cyrilzakka/clinical-trials huggingface dataset:
Psychological Intervention Using Smartphone Technology to Alleviate Malignant Pain

The purpose of this study is to develop and pilot test a novel medical intervention (STAMP+CBT app) that will help patients track their pain, mood, opioid use and side effects while delivering tailored education and self-management advice for patients with advanced cancer.

The primary purpose of this project is to determine the feasibility and acceptability of a novel mobile health application (STAMP+CBT app). The STAMP+CBT app (Smartphone Technology to Alleviate Malignant Pain + Cognitive Behavioral Therapy) seeks to provide education about pain medications alongside cognitive behavioral therapy techniques for pain to patients with advanced cancer. The application uses multi-media educational materials and survey algorithms assessing pain, medication usage, mood, stress, and sleep to improve pain management in this population. In this study, patients with advanced cancer at OU will participate in a single-arm, 6-week study of STAMP+CBT (4-week intervention period and a 2-week post-intervention period).

Eligibility Criteria:
Cohort Inclusion Criteria:

* Age ≥ 18 years
* Patient diagnosed with an active cancer diagnosis (locally advanced solid tumor malignancy, multiple myeloma, or other advanced hematologic malignancy), either undergoing active treatment or receiving treatment for an advanced cancer or are receiving supportive care
* Chronic pain related to cancer or treatment (\> pain score of 4)
* Has an active prescription for at least one opioid medication to treat their cancer pain (i.e. not for post-surgical pain)
* Completed baseline survey

Cohort Exclusion Criteria:

* Patients in survivorship: patients who have completed their treatment regimens, are not actively receiving treatment for an advanced cancer, or have a cancer that is in remission
* Cognitive impairment that would interfere with study participation, as judged by treating clinician
* Inability to speak English (the intervention has not yet been translated to Spanish)
* Enrolled in hospice
* Currently hospitalized
* Use of transmucosal fentanyl, given safety concerns and ongoing risk mitigation program required to prescribe these (TIRF REMS)
* Pain primarily related to a recent surgery (within the last 2 weeks)

We will exclude adults who are unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners.
Effects of REnal Denervation for Resistant Hypertension on Exercise Diastolic Function and Regression of Atherosclerosis and the Evaluation of NEW Methods Predicting A successfuL Renal Sympathetic Denervation (RENEWAL-EXERCISE, -REGRESS, and -PREDICT Trial From RENEWAL RDN Registry)

1. (RENEWAL-EXERCISE trial) The investigators hypothesize that the increased sympathetic nervous system activation that is associated with resistant hypertension is a major contributor in the pathogenesis of exercise diastolic dysfunction and that modulation of the sympathetic nervous system activity with radiofrequency ablation of the renal artery sympathetic nerve fibers delivered via a treatment catheter, will have a significant effect on the diastolic function that is beyond BP-lowering effect.
2. (RENEWAL-REGRESSION trial) The major cause of mortality and morbidity in hypertension is atherosclerotic cardiovascular disease. the significant decrease in the sympathetic nervous system activation after renal sympathetic denervation will contribute to regression over and beyond it's effect of blood pressure reduction.
3. (RENEWAL-PREDICT trial) No data exists regarding the tests or methods predicting the successful renal denervation causing the effective reduction of BP. For these, the investigators sought to perform the new tests such as adenosine infusion test during procedure and skin sympathetic activity measurement before and immediate post-procedure (detailed explanation provided in section of Methods) and then evaluate the association between these tests and reduction of BP following procedures.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20-85 years with resistant hypertension defined as systolic BP\>140 mmHg (\>130 mmHg for diabetes) or diastolic BP\>90mmHg (\>80 mmHg for diabetes) despite adequate administration of 3 or more different classes of anti-hypertensive medications including diuretics with good adherence and adequate treatment regimen.
* All agents should be prescribed at optimal dose amounts. BP was based on an average of 3 office BP readings measured according to the general guidelines. Patients are adhering to a stable drug regimen including 3 or more antihypertensive medications (with no changes for a minimum of 2 weeks prior to enrollment).
* Patients provided with the written, informed consent to participate in this study

Exclusion Criteria:

* Hemodynamically or anatomically significant renal artery abnormalities, main renal arteries \< 4 mm in diameter or \< 20 mm in length, or.prior renal artery intervention
* Estimated glomerular filtration rate (eGFR) of \< 30mL/min/1.73m2, using the MDRD calculation
* Hemodynamically significant valvular heart disease
* History of congestive heart failure with reduce LV ejection fraction of less than 35%
* CVA in the prior 3 months
* ST-segment elevation MI within 48 hours
* Scheduled or planned surgery or cardiovascular intervention in the next 6 months.
* Patients with chronic debilitating disease with life expectancy of less than 1 year
* Patients taking hormone replace treatment and/or oral contraceptives; pregnant, nursing or planning to be pregnant
* Chronic liver cirrhosis
Impact of Tele-visit on Patients Continous Positive Airway Pressure (CPAP) Follow-up by Home Care Provider

To determine the impact of telecare on continous positive airway pressure (CPAP) patients follow up by home care provider (HCP)

Obstructive sleep apnea (OSA) syndrome is a chronic respiratory pathology affecting 4% of french adult population and reference treatment for moderate to severe forms of obstructive sleep apnea syndrome (OSA) is continuous positive airway pressure (CPAP).

However, CPAP treatment is binding, so nearly a quarter of patients abandoning treatment at 1 year and nearly half of them at 3 years. Support for these patients on CPAP must therefore be optimal and seek patient satisfaction; HCP (Home Care Provider) plays an important role in this follow-up.

Since 2018 in France, teleconsultation entered on common law but was little used. The pandemic has disrupted the habits of care and patients monitoring by developing remote monitoring. Home Care Providers (HCP) have also been forced to organize remote monitoring, particularly for the annual follow-up visit (technical tele-visit).

The impact of the annual follow-up visits of HCP by tele-visit has never been clinically evaluated. If its clinical relevance were demonstrated and patient satisfaction confirmed, this follow-up modality could become, like telecare, a new standard for the follow-up of patients on CPAP.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* CPAP ≥ 12 months and annual followed by "AGIR à dom" health care provider.
* Compliance with CPAP ≥ 4h/night and AHI ≤ 5 events/hour on machine report for the 3 months prior to inclusion

Exclusion Criteria:

* Follow-up by AGIR à dom. for an other service than package F9.1 : CPAP follow-up and remote monitoring
* Unacceptable level of mask leakage
* Patient unavailable or willing to move within the next 12 months to an area not covered by AGIR à dom.
* Patient considered by the investigator to be unfit for a tele-visit
Thrombopoietin Levels and Platelet Transfusion in Neonates

Infants who have low platelets and who require a platelet transfusion are included in this study. Platelet transfusions are routinely given to infants when their platelet count falls below a certain level. The study will look at the amount of platelets transfused. The purpose of the study is to evaluate the effect of platelet transfusions on the level of a protein (thrombopoietin) which is known to help control platelet production.

Thrombocytopenia, defined as a platelet count \< 150,000/mm3, is a very common hematologic problem in the neonatal period. Multiple etiologies are known to be associated with thrombocytopenia in neonates. Thrombopoietin (TPO) is known to be the central regulator of megakaryocyte and platelet production in adults and infants. However, the role of TPO in neonatal platelet regulation is not well understood. TPO levels have been shown to be higher in neonates with thrombocytopenia, with a decrease in TPO after resolution of the thrombocytopenia. The response of TPO levels in neonates after platelet transfusion has never been studied. In addition, the optimal volume of platelet transfusions has never been studied in neonates. This study will evaluate the response to 2 different volumes of platelet transfusion.

We hypothesize that a decrease in plasma TPO levels will be seen following a platelet transfusion in a population of neonates with thrombocytopenia. We also hypothesize that a platelet transfusion of 15 mL/kg will result in a greater rise in platelet count than a transfusion pf 10 mL/kg of platelets.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants with thrombocytopenia
* Decision made by medical team to transfuse with platelets

Exclusion Criteria:

* Infants with major congenital malformations
Encouraging Healthy and Sustainable Dietary Substitutions

The aim of this study is to examine emerging adults' responses to dietary substitution messages about health, the environment, or both health and the environment.

This online study will examine emerging adults' responses to dietary substitution messages about 4 different topics. Participants will be randomized to 1 of 4 topic arms: 1) Control (neutral topic, not related to health or the environment); 2) Health topic; 3) Environment topic; 4) Health and Environment topic. Participants will view messages about each of 4 dietary substitutions: replacing red meat with chicken or vegetarian options; replacing dairy milk with non-dairy milk; replacing juice with whole fruit; and replacing sugar-sweetened beverages with water. For each dietary substitution, participants will view 2 messages about their assigned topic, with the 2 messages shown in random order. Participants will rate each message on perceived message effectiveness (primary outcome).

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-25 years
* Reside in the United States
* Ability to complete a survey in English

Exclusion Criteria:

* Older than 25 years; younger than 18 years
* Reside outside of the United States
* Unable to complete a survey in English
Functional Recovery After Partial Hip Arthroplasty: Anterior or Posterolateral Approach?

Hueter anterior approach as described by Siguier allows an anatomical approach without muscle or tendon sections. It minimizes the rate of dislocation after primary total hip arthroplasty (1.5%, Sariali)and seems to allow quicker rehabilitation.

The investigators hypothesis was Hueter anterior approach allows quicker functional recovery after partial hip replacement.


Eligibility Criteria:
Inclusion Criteria:

* Femoral Neck Fracture
* Partial Hip Arthroplasty

Exclusion Criteria:

* Total Hip Arthroplasty
* Osteosynthesis
* Pathologic fracture
TCM for Post-operative Edema

There are loads of research on knee surgery, including surgical methods, rehabilitation strategies, and complication prevention. Whether it is general surgery or endoscopic surgery, there may be postoperative joint swelling, which may last for several weeks depending on the patient's condition. Therefore, reducing swelling as soon as possible is important in post-operative treatment. Swelling of the knee joint may increase soft tissue tension, causing pain and discomfort, and affecting the range of motion and functional recovery of the joint. It may also affect wound healing and increase the risk of complications such as infection and thrombosis. Most clinical research related to traditional Chinese medicine focuses on reducing pain, and little attention is paid to reducing swelling, relatively. Nevertheless most relevant literatures discuss total knee replacement surgery.

Cruciate ligament surgery is very common in sports medicine orthopedics. It is expected that ordinary patients get function recovery quickly after surgery, and athletes can return to play as soon as possible. This study is a prospective study, with partially double-blinded, randomized controlled study design. The investigators are aiming to TCM intervention for knee swelling after cruciate ligament surgery, and evaluation of postoperative swelling and functional improvement. TCM intervention methods are laser acupuncture and external application of herbal medicine.


Eligibility Criteria:
Inclusion Criteria:

1. Willing to sign informed consent
2. Age between 18-50 years old male and female patients
3. First time receiving cruciate ligament reconstruction
4. Willing to accept TCM intervention and follow up

Exclusion Criteria:

1. Repeat surgical intervention
2. History of serious acupuncture syncope
3. History of severe allergic response of herbal packing or drug-induced dermatitis
4. History of other diseases that cause knee joint swelling, such as rheumatoid arthritis, knee joint infection, gouty arthritis, connective tissue disease, tumor, or cardiac/renal failure.
Denosumab vs Zoledronic Acid and Osteoporotic Compression Fracture

Bone mineral density and function at 1 year after screw fixation with denosumab vs zoledronic acid for osteoporotic vertebral compression fractures: a parallel double-blind randomized controlled clinical trial

Conduct a single-center, double-blind, randomized controlled clinical trial according to clinical Trial Reporting Standards (CONSORT). Bone mineral density and function of osteoporotic vertebral compression fracture (OVCF) were compared 1 year after screw internal fixation with denosumab vs zoledronic acid in Shenzhen People's Hospital from September, 2021 to November, 2022. The study was approved by Shenzhen People's Hospital and informed consent was signed.

Eligibility Criteria:
Inclusion Criteria:

* Must be age between 40 and 90 years old
* X-ray diagnosis of 1-2 vertebral compression fractures
* Dual eneragy X ray test for bone mineral density T value less than -1
* fracture history lasted within 6 weeks
* Must be MRI showed bone marrow edema of injured segment
* Must be lower back pain, local spines tenderness

Exclusion Criteria:

* Must be able to have no posterior vertebral wall fracture
* Must be able to have no patients with intervertebral fissure
* Must be able to have no infection
* Must be able to have no malignancy
* Must be able to have no neurological dysfunction
* Must be able to have no calcium level ≤2.13 mmol/L
* Must be able to have no previous use of anti-osteoporosis drugs
* Must be able to have no inability to perform magnetic resonance imaging
* Must be able to have no prior back surgery
* Must be able to have no other established contraindications for elective surgery
Normal Donor Blood Draws for Platelet Studies and Biomarker Evaluation (ND-PLT)

This is a single-center study at the Cleveland Clinic Main Campus designed to study biomarkers in healthy individuals to identify novel mechanisms of platelet activation and how platelets drive vascular inflammation and thrombosis in diseases.

Our past studies have discovered novel platelet activation pathways that may be targets of therapeutic development. We have also defined an important role for a shift in platelet phenotype in vascular disease. Our studies use both in vivo animal models and validation using human platelets from isolated blood. Platelets from healthy individuals may be compared to patients with vascular diseases in the IRB approved protocol "Vascular Lab Resource" (IRB #19-1451) study which is actively recruiting patients at the Cleveland Clinic Main Campus and studies patients with vascular diseases.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 to 65 years old
* Healthy Male \& Female voluntary participants

Exclusion Criteria:

* Individuals who have taken anticoagulant or antiplatelet medications in past 10 days
* Individuals with hematopoetic diseases
Norepinephrine Versus Phenylephrine Continuous Variable Infusion in Cesarean Delivery

Comparison will be conducted between continuous variable infusions of Phenylephrine with starting dose of 0.75 mcg/Kg/min and Norepinephrine Bitartrate with starting dose of 0.1 mcg/Kg/min (with norepinephrine base of 0.05 mcg/Kg/min) for prophylaxis against Post-spinal hypotension during cesarean delivery

Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Many vasopressors have been used for prevention of post-spinal hypotension (PSH) during CD; however, the optimum protocol for prophylaxis is not established yet. Phenylephrine (PE) is a popular vasopressor used in obstetric anesthesia; however, its use is limited by its marked cardiac depressant nature. Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonistic activity in addition to a weak β adrenergic agonistic activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to PE. In this study, the investigators will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.05 mcg/Kg/min respectively for prophylaxis against PSH during CD. We used Norepinephrine Bitartrate 8 mg ampules which contains norepinephrine base of 4 mg.

Eligibility Criteria:
Inclusion Criteria:

* Full term
* Pregnant women
* Scheduled for cesarean section

Exclusion Criteria:

* Pre-eclampsia
* Eclampsia
* Bleeding
* Cardiac dysfunction
Bootcamp During Neoadjuvant Chemotherapy for Breast Cancer

This is a randomized, single-site pilot study incorporating one control group. This research involves an exercise group and a non-exercise group (control group).

The patients who are in the exercise group will be enrolled in the Dallas County Women's Adventure Boot Camp. This will require them to undergo exercise training 3 times per week, under the direction of an experienced personal trainer in a group setting. All Boot Camp personal trainers are trained in basic cardiac life support (CPR) and are trained to watch for any signs or symptoms associated with a poor exercise response.

The investigators hypothesize that randomizing women to a supervised exercise program of core conditioning, muscular/circuit training, and short distance running administered during neoadjuvant chemotherapy for breast cancer can be performed.

Patients will continue on study as they are undergoing neoadjuvant chemotherapy for their breast cancer. This will be about 4 - 6 months.

The exercise protocol will consist of activities including walking/running up to a mile, calisthenics (jumping jacks, short relays, rapid punches) and light (no greater than 5 pounds) weight lifting. The patients who do not receive the exercise program will be allowed to do what they would normally do during their neoadjuvant chemotherapy. They are allowed to engage in their own exercise regimens and diet modifications.

Subjects will receive the chemotherapy as directed by their physicians, and then undergo surgery as planned. Randomization will occur by drawing cards entitled "exercise" or "control" from an envelope and then assigning the patient to this group.

Eligibility Criteria:
Inclusion Criteria:

1. Receiving neoadjuvant chemotherapy for breast cancer at one of the UT Southwestern hospitals or affiliates (Simmons Cancer Center, Parkland Hospital)
2. No evidence of metastatic disease as confirmed by routine staging
3. 18 - 70 year old female
4. Karnofsky score \>80%
5. Body Mass Index \>25 kg/m2
6. Able to speak, read and understand the English language
7. Ability to understand and willingness to sign a written informed consent document
8. All races and ethnicities will be eligible.

Exclusion Criteria:

1. Unable to speak, read and understand the English language
2. Patients may not be involved in other trials evaluating the efficacy of neoadjuvant therapy
3. Insulin-dependent diabetic patients.
4. Known to be pregnant or planning to become pregnant during the study.
5. Subjects are prohibited from being on other cancer treatments aside from what their treating medical oncologist has prescribed, primarily additional chemotherapies.
Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine

The purpose of this study is to assess the efficacy and safety of ALD403 in the prevention of migraine headache in chronic migraineurs.


Eligibility Criteria:
Inclusion Criteria:

* Males and females between 18 and 65 years of age, inclusive, who were diagnosed with migraines at ≤ 50 years of age, and have a history of chronic migraine for ≥ 12 months before screening.
* During the 28 day screening period, subjects must adequately complete the headache eDiary and must have headaches occurring on ≥ 15 to ≤ 26 days of which at least 8 must be migraine days.
* Headache eDiary was completed on at least 24 of the 28 days prior to randomization.

Exclusion Criteria:

* Confounding and clinically significant pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome).
* Psychiatric conditions that are uncontrolled and/or untreated, including conditions that are not controlled for a minimum of 6 months prior to screening. Patients with a lifetime history of psychosis, mania, or dementia are excluded.
* Any use of botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections within 4 months prior to screening and during the screening period.
* History or diagnosis of complicated migraine (ICHD-III beta version, 20134), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or sporadic and familial hemiplegic migraine.
* Receipt of any monoclonal antibody treatment (within or outside a clinical trial) within 6 months before screening.
* Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway.
A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203

The purpose of this study is to determine the continued effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism who have completed protocol ZA-203. Men will be allowed to choose Androxal (enclomiphene citrate) or Testim (topical testosterone) at the beginning of the study. All men on Androxal will start at 12.5 mg and will be allowed to up titrate to 25 mg if an inadequate response is exhibited at the lower dose.


Eligibility Criteria:
Inclusion Criteria:

* Successful completion of ZA-203
* Ability to understand and provide written informed consent
* Agreement to use a condom, and with a fertile female partner, another form of contraception
* Agreement to provide semen samples in the clinic

Exclusion Criteria:

* Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study
Description of Ophthalmologic Injuries in Intensive Care During the SARS-CoV2 Epidemic - COVID19

The management of patients with SARS-CoV2 in respiratory distress can expose to corneal or retinal lesions induced by the stay in intensive care.

Examination by ophthalmologists would make it possible to detect the most of the ophthalmologic problems known in intensive care and to provide an early, preventive or curative therapeutic response when possible, in order to avoid irreversible visual loss.

The object of the research is to assess the presence and the importance of surface ophthalmologic lesions, the presence and the importance of retinal or optic nerve lesions, in order to improve the monitoring and primary prevention of this population


Eligibility Criteria:
Inclusion Criteria:

* patient SARS-CoV2 positive (RT-PCR or chest scanner)
* hospitalized in intensive care

Exclusion Criteria:

* traumatic lesion of the face or any other condition preventing any ophthalmological evaluation