cyrilzakka/clinical-trials huggingface dataset:
Disease-related Fatigue Monitoring Based on Body Signals Measured on the Skin

This study investigates the use of physiological parameters as predictors of disease-related fatigue. For that purpose, wearable devices are used to monitor post-COVID-19 patients during their stay in a rehabilitation clinic. Besides, the effectiveness of respiratory training in reducing breathlessness and improving exercise breathing patterns in patients suffering from post-COVID-19 will be explored.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years old)
* suffering from post-COVID-19 fatigue (i.e., score equal or higher than 5 on the single-item fatigue \[SIF\] or the Fatigue Severity Scale \[FSS\])
* admitted to Gais rehabilitation clinic
* able to use a mobile phone
* able to wear and handle the monitoring devices

Exclusion Criteria:

* Patients suffering from a relevant comorbidity (i.e., comorbidity resulting in significant distortion of physiological signals \[e.g., moderate to severe chronic obstructive pulmonary disease or persistent atrial fibrillation\])
* pregnancy
* unable to use, wear or handle the monitoring systems
Administration of Surfactant Through an Instillation Device Infasurf® (Calfactant) in Neonates- A Pilot Study

A pilot study to explore and determine feasibility and safety of the administration of surfactant through a new supraglottic device in patients from 500 to 5000 grams with RDS.

Surfactant therapy can be life-saving for newborn infants with respiratory distress due to surfactant insufficiency, also known as respiratory distress syndrome (RDS). All commercially available surfactants for clinical use are approved for administration through an endotracheal tube. Placement of an endotracheal tube, a procedure called intubation, is stressful for the infant and associated with significant adverse effects. The proposed supraglottic instillation device allows infants to benefit from surfactant therapy while avoiding the negative effects of intubation.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age at the time of enrollment ≥ 24 0/7 weeks
* Weight at the time of enrollment 500- 5000 grams
* Age ≤ 24 hours old
* Require non-invasive respiratory support (i.e. continuous positive airway pressure, high flow nasal cannula or non-invasive ventilation)
* Require FiO2 ≤ 40%
* Clinical diagnosis of RDS

Exclusion Criteria:

* Prior surfactant administration
* Prior mechanical ventilation
* Major congenital anomaly
* Abnormality of the airway
* Respiratory distress secondary to an etiology other than RDS (suspected pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemia shock, hypoxic ischemic encephalopathy)
* Apgar score \< 5 at 5 minutes of age
The Vascutek Custom Fenestrated Anaconda Post-Market Surveillance Study

This is a multicentre, prospective, observational post-market registry (follow-up 1 month, 1 year, 2 years, 3 years, 4 years and 5 years) to monitor the post-market clinical safety and effectiveness of the Vascutek AnacondaTM Custom Fenestrated Stent Graft in patients with a short infrarenal neck of \<15mm or juxta-renal abdominal aortic aneurysms who, in the opinion of the treating physician, are anatomically suitable for the AnacondaTM Custom Fenestrated Stent Graft and for whom a customised medical device is required.

AnacondaTM Custom Fenestrated Devices (CFD) are designed for the endovascular repair of abdominal aortic aneurysms (AAA) for cases where the aneurysm extends superiorly very close to or involving the renal arteries, leaving insufficient neck length for infrarenal device sealing. The non-CE marked devices are custom designed based on CT scan data of the patient's aorta and regulated in accordance with the Medical Device Directive (93/42/EEC) and associated country specific regulations as applicable.

The proximal end of the AnacondaTM fenestrated body device is positioned suprarenally, where it seals and fixates in the vessel by means of rings comprised of multiple turns of fine nitinol wire, attached to the fabric with polyester sutures, creating a self-expanding stent which provides a conformable seal with the vessel wall and assists in anchoring of the device. Nitinol hooks provide secure fixation within the suprarenal aorta. The saddle shape of the rings allows the superior mesenteric artery (SMA) or celiac artery to be accommodated in the valley of the top ring saddle in some cases.

The objective of the registry is to provide long term (5 year) safety and effectiveness data of all patients who consent to their data to be used in the registry. This data aims to demonstrate that the Vascutek AnacondaTM Custom Fenestrated Stent Graft is safe and effective in patients with a short infrarenal neck of \<15mm or juxta-renal abdominal aortic aneurysms who, in the opinion of the treating physician, are anatomically suitable for the AnacondaTM Custom Fenestrated Stent Graft.

Eligibility Criteria:
Inclusion Criteria:

A patient with juxta renal abdominal aortic aneurysms (AAA) who, in the opinion of the treating physician, is anatomically suitable for the Anaconda Fenestrated Graft and for whom a customised medical device is required.

Exclusion Criteria:

1. Ruptured or symptomatic aneurysm
2. Clinically significant concomitant medical disease or infection
3. Connective Tissue Disease (e.g. Marfan's Syndrome)
4. Known allergy to nitinol, polyester or contrast medium
5. Excessive tortuosity of access vessels (femoral or iliac arteries)
6. Landing zone of less than 10mm in the visceral segment of the aorta
7. Inability to comply to follow up protocol
8. Access vessels less than 6mm in diameter
9. Diseased or excessively tortuous access to target vessels
10. Target vessels of less than 5mm in calibre
11. Excessive calcification or thrombus at the intended landing zone which could affect sealing
Time Based Effects of Different Duration Stretching on Calf Muscle Strength

Stretching is reported to decrease muscle strength and thus suggested to be avoided prior to athletic events but with conflicting reports. This time course study aimed to assess acute effects of static stretching of different durations on isometric maximum voluntary contraction force of calf muscle.

Stretching is reported to decrease muscle strength and thus suggested to be avoided prior to athletic events but with conflicting reports. This time course study aimed to assess acute effects of static stretching of different durations on isometric maximum voluntary contraction force of calf muscle. Pretest posttest experimental design was used. 14 subjects participated in three experimental trials: Static stretching for 2 minutes (SS2), static stretching for 4 minutes (SS4), and static stretching for 8 minutes (SS8). Strength was measured before (pre), immediately after (post), and at 10- and 20- minutes post stretching. Each static stretching (SS) trial involved varied repetitions of 30-seconds self-stretches and 20-seconds relax periods.

Eligibility Criteria:
Inclusion Criteria:

* Subjects performed active foot dorsiflexion in long sitting position with back supported against wall and those having not more than 20-degree range of motion were selected
* Used to engage in 1 to 5 hours of physical activity per week

Exclusion Criteria:

* Subjects having any current injury or limits in range of motion specific to lower limb joints
* Current neuromuscular disease
* Competitive athletes were excluded from the study
Non Invasive Biomarkers to Identify Subjects at Risk for Preterm Delivery

The goal of this study is to identify a non-invasive predictor or predictors that will increase the clinician's ability to identify patients with preterm labor (PTL) at risk for preterm delivery (PTD). Through these studies we also hope to reveal potential therapeutic targets in the prevention of prevention of preterm births.

The study hypothesis is that we can identify non-invasive predictors of PTL at risk for PTD.

STUDY DESIGN This is a prospective study involving a cohort of pregnant subjects with pre-term labor. Maternal blood and cervical/vaginal fluid will be collected from consenting subjects with preterm labor. Repeat sampling of cervical fluid will occur as often as weekly until the time of delivery. Relevant clinical and demographic data will be recorded. Levels of prostaglandins (PG's), lipocalin-type prostaglandin D2 synthase (L-PGDS) and cytokines will be determined using ELISA. DNA will also be extracted from maternal blood for SNP analysis of cytokine genes. At the time of delivery, cord blood and placenta samples will be collected if logistically possible (during regular laboratory hours). To determine fetal levels of PG's, L-PGDS and cytokines in cord blood will be analyzed using ELISA. Placental samples will be used for in vitro studies aimed at investigating the placental regulatory pathways of cytokine and PG production. Placental samples will also be processed and embedded in paraffin for use in immunohistochemical studies in order to localize the expression of PG's and cytokines. Clinical delivery data will also be recorded.

Gender of Subjects. Only female subjects will be included.

Age of Subjects. The age of subjects will be restricted to 18-45 years.

Inclusion Criteria. Women with a diagnosis of preterm labor will be included in this study. Preterm labor will be diagnosed as

Six or more contractions per hour associated with one of the following:

1. cervical dilation \>= 2 cm
2. cervical effacement \> 80%
3. documented changes in dilation or effacement

OR Cervical length less than 2.5 cm by ultrasound with or without contractions.

Exclusion Criteria. Multiple pregnancy, fetal anomalies, abruptio placenta, preeclampsia, cervical dilation greater than 4 cm, clinical signs of infection and vaginal bleeding.

Subject Capacity. All subjects included in this study will have the capacity to give informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Women with a diagnosis of preterm labor.

Exclusion Criteria:

* Multiple pregnancy, fetal anomalies, abruptio placenta, preeclampsia, cervical dilation greater than 4 cm, clinical signs of infection and vaginal bleeding
Effect of Curcumin in Treatment of Squamous Cervical Intraepithelial Neoplasias (CINs)

The purpose of this study is to determine the safety, feasibility, and regression rate of using curcumin in patients with Cervical Intraepithelial neoplasias (CIN3). The secondary objectives of this study is to evaluate patients with CIN3 for the presence of high-risk Human papillomavirus (HPV) and to perform an inflammatory panel on dysplasia biopsies from patients with CIN3 to determine which factors play a role in persistence of CIN3.

Fourteen women with a biopsy-confirmed CIN3 diagnosis will be enrolled. The participants will receive 500mg of curcumin orally twice daily for 12 weeks. Colposcopies will be performed at the participants' baseline, 6 week, and 12 week visits. Two biopsies will be performed at the baseline and 12 week visit, and if there is suspicion for cancer formation or invasion, at the 6-week visit. One sample will be used for histologic examination, while the other sample will be used for p65 assays. Based on the biopsy, if cancer is present, then the patient will be referred to gynecologic oncology for further care and the trial will be terminated. At the end of the 12 week period, if CIN3 persists, Loop electrosurgical excision procedure (LEEP) or Cold knife conisation (CKC) will be performed to remove the dysplastic cells as this is considered standard of care.

Eligibility Criteria:
Inclusion Criteria: A patient will be eligible for inclusion in this study if she meets all of the following criteria:

1. The patient must be 21 or older and able to give informed consent.
2. Patient must have histologically confirmed squamous CIN3.
3. There must be an adequate colposcopy.
4. Patient must have no abnormal cells in their endocervical curettage (ECC).
5. There must be no suspicion of invasion.

Exclusion Criteria: A patient will be ineligible for inclusion in this study if she meets any of the following criteria:

1. Women who are pregnant or lactating.
2. HIV+ status
3. Adenocarcinoma in situ or any invasive cancer of the cervix.
4. Gallstones or bile duct obstructions.
5. Patients on anti-coagulant/anti-platelet therapies.
6. Patients on immunosuppressive therapies.
7. Patients may not receive any other investigational treatments while participating in this study.
8. Concurrent severe, uncontrolled infection or intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
Cannabinoid Augmentation of Fear Response in Humans

The purpose of this double blind, randomized, controlled, proof-of-concept study is to test the effects of cannabinoid receptor augmentation on the facilitation of fear conditioning. On three days over not more than two weeks, subjects will be trained to associate cues with two different stimuli, then this association will be extinguished. Cannabinoid receptor stimulation will be accomplished indirectly by harnessing the brain's capacity to endocannabinoids through the administration of an enzyme (FAAH inhibitor) that prevents degradation of anandamide. Subjects will receive placebo or the FAAH-inhibitor PF-04457845. Some details of this study have not been disclosed to preserve the study design.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 65
* Male and female
* No major medical problems

Exclusion Criteria:

* Hearing problems
* Psychiatric or mental problems
Topiramate Trial for Compulsive Buying

It is a double blind controlled study to test the hypothesis that Topiramate is more effective than placebo in the treatment of compulsive buying, during a period of 12 weeks

Compulsive buying is a prevalent disorder with no approved pharmacological treatment. Previous reports suggest that topiramate could be useful in reducing impulsivity in pathological gambling and other impulse control disorders, as well as craving in substance addictions. The goal of this study was to investigate the effectiveness of topiramate combined with brief cognitive restructuring in treating compulsive buying, compared with just cognitive restructuring treatment+placebo.

Eligibility Criteria:
Inclusion Criteria:

* Match criteria for compulsive buying, according to McElroy et al. (1994), confirmed by semi-structured interview modeled after the Schedules for clinical assessment in neuropsychiatry (SCID)
* woman within fertility age have to be already practicing an acceptable contraception method and to be negative at a pregnancy test

Exclusion Criteria:

* illiteracy
* pregnancy and breastfeeding for woman
* previous history of alcohol abuse/dependence with current elevation of liver enzymes, or a present diagnosis of alcohol abuse/dependence
* past or current drug abuse/dependence, except for nicotine
* history of current or past Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders diagnosis of bipolar disorder, schizophrenia, psychosis or any neuropsychiatric condition causing cognitive impairment
* a history of suicide attempt or acute suicide risk
* severe depression indicated by a score higher than 30 at the beck depression inventory
* current participation on psychotherapy or use of pharmacological agent or experimental dispositive for compulsive buying in the past 3 months
* current use of psychotropic drugs, except benzodiazepines
* cardiovascular disease including a history of heart attack, stroke, arrhythmia, cardiac failure in the past 5 years. Uncontrolled high blood pressure.
* chronic or acute renal or liver failure, as well as Retinopathy and thyroidopathy
* a personal or family history of nephrolithiasis
* immunodeficiency
* any blood dyscrasia
* contraindication or allergy to topiramate
* history of seizures
* dont't have a phone number for contact
* live alone and don't have a person that can inform about the shopping behavior
Evaluation of Letters Promoting Colorectal Cancer Testing

In this evaluation, 4 different versions of letters are being sent with mailers promoting colorectal cancer screening with an at-home test. The researchers hypothesize that the use of behavioral nudges in the message should lead to increased colorectal cancer screening (either with the at-home test or a colonoscopy).

Colorectal cancer (CRC) is the third most common cancer diagnosed in the US. Mailing fecal immunochemical (FIT) kits to at-risk patients is an effective way of increasing CRC testing uptake, as this test can be done at home and is less intrusive compared to colonoscopies. As part of an existing program, the health system mails FIT kits to eligible patients each year. Although this test needs to be conducted annually, not everyone who receives the test kit returns the kits for processing. In this study, the researchers aim to test different letters with the goal of encouraging the use of FIT kits or scheduling a colonoscopy.

As part of this study, the kits are mailed with everything the patient will need to conduct the test at home and mail a sample back to the hospital. It also includes an introductory letter informing the patient about the program and inviting them to use the kit. The researchers are comparing a standard version of the introductory letter against 3 versions that include different combinations of behavioral nudges, specifically framing effects (loss, default, decoy) and fear appeals.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in Medicare Health Maintenance Organization (HMO) and Preferred Provider Organization (PPO; age 65 and older) or Commercial HMO in one large employer's group
* Has a flag indicating that the person is due for a colon cancer screening

Exclusion Criteria:

- Members who are on the do not contact list at Geisinger Health Plan
Regenexx™ SD Versus Exercise Therapy for Treatment of Knee Osteoarthritis With Historical Comparison to TKA

The primary objective of this study is to evaluate the efficacy of Regenexx SD compared to Exercise Therapy at three months. Historical comparison will be made to Total Knee Arthroplasty for treatment of knee osteoarthritis at 1 and 2 years.

The study is single center, prospective, randomized, controlled trial to include 50 subjects, 25 treated with Regenexx SD and 25 treated with Exercise Therapy for treatment of knee osteoarthritis. Subjects will be enrolled within 60 days prior to Regenexx-SD injection or initiation of Exercise Therapy and take part in follow-up visits for two years following treatment. A preoperative visit will occur at the time of enrollment; follow-up visits will occur at the clinical site at 6 weeks, 3 months, 6 months, 12 months, and 24 months post injection.

Subjects in the control, exercise therapy arm, will have the opportunity to cross-over to the study treatment arm at or after the 3 month visit and then continue to be followed through 24 months.

Subjects will complete the study following the 2 year follow-up visit. They will be withdrawn from the study prematurely if a revision occurs.

The study subjects will be compared to a historical total knee arthroplasty group. Data of the TKA group subjects will be reviewed retrospectively after it is retrieved from the clinical database. The TKA group will consist of patients who underwent TKA for knee osteoarthritis. The inclusion criteria of age and BMI will be applied to these subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntary signature of the IRB approved Informed Consent
2. Ages 18 to 70
3. Diagnosis of Knee osteoarthritis
4. Kellgren-Lawrence Grade 2 or 3 on X-Ray
5. BMI of \<30
6. Minimum flexion to 110 degrees
7. Varus under 12 degrees/Valgus under 15 degrees
8. Instability in any plane less than 2 mm translation
9. ACL intact and no history of ACL reconstruction
10. Knee Society 100 point score \> 65
11. If bilateral arthritis, subject must be able and willing to delay treatment of the second side for at least 6 months
12. Candidate is able to follow Regenexx medication guidelines
13. Patient agrees to return for periodic assessment protocol
14. Patient must execute all required documents
15. Patient must be appraised of Clinical Trial

Exclusion Criteria:

1. History of infection of the joint in the last five years
2. Intra-articular PRP, steroid or viscosupplementation in the last three months
3. Previous knee surgery within the last 6 months
4. Flexion contracture over 15 degrees
5. Low back pain with radiculopathy or with "significant" radiographic changes
6. History of immunosuppressive or chemotherapy in the last five years
7. Systemic neurological disease
8. HIV positive or chronic hepatitis
9. Any significant co-morbidity that in the opinion of the investigator should exclude the subject from the study
Value-Based Medicine (VBM) for Lung Cancer

This is a prospective observational monocentric trial. The primary endpoint is the validation of predictive models. These predictive models will be used to develop a personalized clinical-functional risk profile for estimating in advance, prior to surgery, the probability for a patient to experience surgical complications, pain, fatigue, dyspnea, as well as issues related to physical function, role, social, and emotional well-being, up to 12 months post-discharge.

The goal of this prospective observational monocentric study is to validate a predictive models in patients with diagnosis of non-small cell lung cancer eligible for surgical lung resection (lobectomy/typical and atypical segmentectomy) with or without neo-adjuvant and adjuvant therapy.

Participants will be asked to complete quality of life questionnaires before surgery and then at 30 days, 4 months, 8 months and 12 months post discharge.

The informations collected through questionnaires, along with clinical data will be used to validate the predictive models created.

These models will then be utilized to develop a personalized clinical-functional risk profile for estimating in advance, prior to surgery, the probability for a patient to experience surgical complications, pain, fatigue, dyspnea, as well as issues related to physical function, role, social, and emotional well-being, up to 12 months post-discharge.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years
* Patients with diagnosis of non-small cell lung carcinoma
* Only patients eligible for surgical lung resection (lobectomy/typical and atypical segmentectomy) with or without neo-adjuvant and adjuvant therapy
* Diagnosis of primary non-small cell lung cancer
* Signed Informed Consent
* Patients must be available for follow-up

Exclusion Criteria:

* Patients with benign lesion
* Patients with recurrence who have already undergone lung surgery
* Conditions/pathologies that prevent the ability to give consent