cyrilzakka/clinical-trials huggingface dataset:
Nerveblocks for Persistent Pain After Breast Cancer Surgery

Persistent pain after breast cancer surgery (PPBCS) affects 25-60% of breast cancer survivors and nerve damage has been implicated as the cause of this neuropathic pain condition. Local anaesthetic blockade of tenderpoints and the intercostobrachial nerve (ICBN) could provide clues to pathophysiological mechanisms as well as aiding diagnosis and treatment of PPBCS but has never been attempted. The aims of this study is to examine clinical effect of ultrasound guided blockades of the ICBN and tenderpoints of pain.


Eligibility Criteria:
Inclusion Criteria:

* At least 1 year after surgery for breast cancer
* Women aged 18 or over
* Suffering from persistent pain in the breast, side of chest, axilla or arm (NRS 4 or over)

Exclusion Criteria:

* Previous cosmetic surgery
* bilateral cancer
* pregnant or lactating
* other disease in the nervous system
* in treatment for psychiatric disease
* unable to understand Danish
* unable to give informed concent
Leveraging Technology to Achieve Equity for Men With Prostate Cancer on Androgen Deprivation Therapy

This clinical trial studies a digital platform, the supportive therapy in androgen deprivation (STAND-T), in achieving equity for men undergoing treatment with androgen deprivation therapy for prostate cancer. STAND-T is a digital platform that provides prostate health information, evidence-based materials and resources. STAND-T may help improve health, address symptoms, and promote equity in men with prostate cancer.

PRIMARY OBJECTIVE:

I. To assess study feasibility of the STAND-T program at the Helen Diller Family Comprehensive Cancer Center (HDFCCC) and Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG) genitourinary (GU) medical, surgical, and radiation oncology practices.

SECONDARY OBJECTIVE:

I. To measure preliminary estimates of acceptability and usage of a digital platform, STAND-T.

EXPLORATORY OBJECTIVE:

I. To describe diet (e.g., fruit and vegetable intake), lifestyle (e.g., moderate to vigorous exercise, smoking status), clinical (symptoms e.g., fatigue), and health related quality of life (QoL) outcomes (e.g., sleep disturbance), physiologic measures (body mass index, BMI) at baseline and change in these metrics from baseline to 3 months post-intervention.

OUTLINE:

Patients review educational material and resources via online STAND-T platform. Patients also receive interactive text messages for 3 months.

After completion of study, patients are followed up at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Ability to understand study procedures and to comply with them for the entire length of the study
* Ability of individual or legal guardian/representative to understand an informed consent document and the willingness to sign it
* Adenocarcinoma of the prostate
* Current or planned anti-androgen therapy (ADT) (oral or injection) with gonadotropin-releasing hormone (GnRH) antagonist or luteinizing hormone releasing hormone (LHRH) agonist
* Life expectancy duration of 6 months or longer from date of study consent
* Prior and concurrent radiation is allowed
* Treatment with concurrent androgen signaling inhibitors is allowed
* \< 75 minutes/week of vigorous aerobic exercise based on Godin survey or \< 2 days per week of vigorous activity

Exclusion Criteria:

* Contraindication to any study-related procedure or assessment
* Planned surgery/chemotherapy/immunotherapy/parp inhibitor treatment during the study period
* Prior and concurrent investigational therapies
* Unable to read/speak English
* Unable to access the Internet
* Has seen an exercise counselor in the past 6 months for prostate or cardiovascular health
* Has seen a dietary counselor in the past 6 months for prostate or cardiovascular health
Consequences and Correlates of Weight Fluctuations

To quantify the association between multiple intentional weight losses (i.e., weight fluctuations) and the development of hypertension and diabetes mellitus among 50,790 female nurses participating in the ongoing Nurses' Health Study II. In addition to assessing the consequences of weight fluctuations, their correlates and course were identified.

BACKGROUND:

In the United States, approximately one third of adult women are trying to lose weight. Most weight losses are not sustained and in fact may be followed by gains of at least as much weight as was intentionally lost. It is unclear whether there are adverse outcomes associated with multiple intentional weight losses.

DESIGN NARRATIVE:

The prospective study addressed the impact of weight fluctuation on development of hypertension (HPT) and diabetes (DM) by following women who significantly fluctuated in weight compared to those who generally maintained a stable weight. The subject source was all participants between 1989 and 1993 in the Nurses Health Study II (NHS) who did not experience a full term pregnancy between 1989 and 1993 and who were free of HPT, DM and cancer in 1993. A random sample of each of two weight fluctuation classifications, \>20 lbs. (3 or more times) and 10-19 lbs. (3 or more times) was identified. A control group of non-fluctuators was matched by age and body mass index strata. Baseline data consisted of information obtained from the 1993 NHS II follow-up along with supplemental questionnaires sent to study participants to elicit specific information on past and present weight gain/loss and intentionality of weight fluctuation. Prospective data came from follow-up questionnaires in 1995, 1997, and 1999. Hypertension and DM ascertainment were obtained from self-report in the questionnaire. This ascertainment method appeared quite adequate based on validity studies carried out on subsamples of this cohort.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
A Study on Prevention Strategies for CKD-SHPT and Related Complications Based on General Vitamin D Supplementation

1. Study content: This is a multicentre, double-blind, randomised controlled study to determine the optimal dose and duration of treatment for the correction of vitamin D insufficiency or deficiency in patients with CKD5d; to investigate whether vitamin D supplementation delays the increase in PTH levels in this group of patients; and to investigate the effects on changes in CKD-MBD-related markers, cardiovascular complications, cognitive function in this group of patients. 2. Study procedure: Based on the inclusion and exclusion of the patients, the study was conducted in accordance with the following criteria
2. Study procedure: Eligible subjects were screened according to inclusion and exclusion criteria and randomly divided into three groups: high-dose vitamin D group, low-dose vitamin D group and control group. Baseline data were collected before the intervention and each group was given different doses of regular vitamin D2 softgels or placebo and followed up. 25(OH)D, PTH, blood Ca, and blood P levels were measured every month; bone metabolism markers, FGF23, and blood counts, liver function, kidney function, lipids, and blood glucose were measured every 3 months; the prevalence of vascular calcification, the incidence of cardiovascular events, and changes in cognitive function scale scores were assessed 6 months after the intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Patients with chronic kidney disease stage 5d who have been on haemodialysis for 3 months or more
3. 5 ng/mL \< 25(OH)D \< 30 ng/mL (liquid phase tandem mass spectrometry).
4. 130 pg/ml \< PTH \< 600 pg/ml (electrochemiluminescence method).
5. serum phosphorus \< 1.78 mmol/L.
6. Good compliance with the treatment requirements formulated for the study.
7. informed consent from the subject.

Exclusion Criteria:

1. Patients who are prepped for or have undergone renal transplantation or parathyroidectomy.
2. taking vitamin D, active vitamin D or analogues and other drugs that may affect 25(OH)D levels within 3 months prior to enrolment
3. Treatment affecting PTH results (e.g. cenacaser, etc.) within 3 months prior to enrolment
4. Serum calcium \> 2.55 mmol/L
5. Patients who are pregnant or likely to become pregnant, breastfeeding or planning to become pregnant during the study period
6. known prior or concomitant serious illness or medical condition such as malignancy, human immunodeficiency virus, severe gastrointestinal or liver disease, intestinal malabsorptive disease, hepatitis or cardiovascular events that may worsen or shorten life expectancy and/or interfere with participation in the study
7. History of neurological/psychiatric disease, including psychosis or dementia, or any other reason that is unlikely to result in adherence to treatment or follow-up plans.
8. Known or suspected allergy to any component of the study drug.
9. Ongoing participation in other clinical studies.
Radiation Exposure Assessment in Fluoroscopy

There has been increasing awareness regarding the risk of radiation exposure to patients and providers when performing procedures requiring fluoroscopic guidance.

Fluoroscopy guidance is routinely used in many endoscopic procedures per standard-of-care practice and there is increasing effort to minimize the degree of radiation exposure to patients and providers during fluoroscopy usage. The current fluoroscopy machine used per standard-of-care practice at the Center for Interventional Endoscopy is the Eview machine (Omega Medical Imaging, Orlando, FL, USA). Recently, CA-100S technology (FluoroShield, Omega Medical Imaging) has been developed in an effort to further reduce the degree of radiation exposure to patients and provides. This technology is an additional component that can be fitted to the preexisting Eview fluoroscopy machine, in order to further filter radiation that has passed through the pre-existing machine. The investigators will be performing this study to determine the degree of radiation exposure to patients and providers when using the Eview fluoroscopy machine, with and without the FluoroShield radiation exposure reduction system.

There has been increasing awareness regarding the risk of radiation exposure to patients and providers when performing procedures requiring fluoroscopic guidance. In a prior study, the Eview machine, which is currently used for fluoroscopy guidance at the Center for Interventional Endoscopy, was shown to decrease, but not completely eliminate, radiation exposure when compared to C-arm type of fluoroscopy machines (GE Healthcare, Wauwatosa, WI, USA). Recently, the FluoroShield technology (Omega Medical Imaging) has been developed in an effort to further reduce the degree of radiation exposure to patients and provides. This technology is an additional component that can be fitted to the preexisting Eview fluoroscopy machines, in order to further filter radiation that has passed through the pre-existing machine.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Having an endoscopy with fluoroscopy

Exclusion Criteria:

* Less than 18 years of age
* Not having an endoscopy with fluoroscopy
A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma (HL)

The primary objective was to provide drug to ongoing patients who were receiving panobinostat and to characterize the safety and tolerability of panobinostat in patients with HL after achieving a complete response following autologous hematopoietic stem cell transplant (AHSCT) with high dose chemotherapy (HDT). Primary objective as stated above reflects a change from the original protocol as of an amendment. The original objective was no longer feasible with only 41 of 367 patients randomized after the study was halted due to poor recruitment. An amendment was written to allow patients on panobinostat to continue their treatment until discontinuation/completion criteria were met (patients were unblinded). Therefore, the study was completed as per this amendment. No secondary objectives were included for this trial from the amendment; this was a change from the original protocol.


Eligibility Criteria:
Inclusion Criteria:

1. Patient age is greater than or equal to 18 years
2. Patient has a history of histologically confirmed classical HL (i.e. Nodular sclerosing (NSHL), Mixed-cellularity (MCHL), Lymphocyte-rich (LRHL), Lymphocyte depleted (LDHL))
3. Patient has achieved a complete response by CT/MRI scan within 9 weeks (± 1 week) from the day of their first autologous peripheral blood/ bone marrow stem cell transfusion (AHSCT) following HDT. Complete response is defined as:

   Normalization of all nodes and lesions compared to pre-transplant scan performed prior to salvage therapy for relapse. Any residual abnormal masses on the post transplant CT/MRI must be metabolically inactive on a PET scan.
4. Patient has at least one of the following factors that places them at risk for relapse:

   * Primary refractory disease (including relapse in ≤ 3 months of completion of 1st line treatment)
   * First relapse \>3 but \<12 months from last dose of 1st line treatment
   * Multiple relapses (prior to transplant)
   * Stage III/IV disease (at relapse, prior to transplant)
   * Hemoglobin \<10.5 gm/dL (at relapse, prior to transplant)

Exclusion Criteria:

Patient has been treated with allogeneic transplant 2. Patient has received any anti-lymphoma therapy after AHSCT including but not limited to:

* chemotherapy prior to start of study
* biologic immunotherapy including monoclonal antibodies or experimental therapy prior to start of study
* radiation therapy 3. Patient has not recovered from reversible toxicity due to any prior therapies (e.g. returned to baseline or Grade ≤1) except for hematological laboratory parameters Note: Patient does not meet this criteria if the toxicity is stable and irreversible, and there is no evidence that panobinostat causes a similar toxicity 4. Patient has received prior treatment with DAC inhibitors including panobinostat
Evolution of Swallowing in Patients Undergoing Lateral Pharyngoplasty With Preservation Stylopharyngeal Muscle

Evolution of swallowing in patients undergoing lateral pharyngoplasty with preservation stylopharyngeal muscle.

refer patients to the side pharyngoplasty with total preservation of stylopharyngeal muscle and evaluate the total recovery time of swallowing, making a daily assessment.

Eligibility Criteria:
Inclusion Criteria:

* patients with obstructive sleep apnea with surgical indication

Exclusion Criteria:

* patients with obstructive sleep apnea without surgical indication
Morphine, Midazolam and Dexmedetomidine in the Management of Acute Cardiogenic Pulmonary Edema, Safety and Efficacy

Acute cardiogenic pulmonary edema is a stressful scenario with progressive respiratory failure that may lead to cardiorespiratory collapse within hours, or minutes unless therapeutic action is taken As the initial events in involve hemodynamic pulmonary congestion with high capillary pressures, diuretics, non-invasive ventilation (NIV) and vasodilators constitute the key armamentarium for the initial treatment.

The patients will be randomized in a 1:1:1 ratio, (group midazolam i) midazolam (administered intravenously at a dosage of 1 mg, up to a maximum dose of 3 mg) (group morphine) morphine (administered intravenously at a dosage of 2-4 mg, up to a maximum dose of 8 mg \[14\], \[15\],(group Dexmedetomidine.) dexmedetomidine ( administered intravenously, Load: 0.25 mcg/kg IV over 10 minutes , Maintenance 0.2-0.7 mcg/kg/hr continuous IV infusion according to haemodynamics and sedation score of patient ; not to exceed 24 hr

• Boluses of morphine, midazolam and dexmeddetomidine will be repeated on demand according to Ramsay sedation scale.

• All patients will be assessed for need of noninvasive ventilation by total face mask connected to ventilator.

• Medical therapy with intravenous boluses of loop diuretics, intravenous infusions of nitroglycerine, oxygen supplementation will be provided by physicians according to their clinical judgment

• The target in all patients is to provide anxiolytic or light sedation effect for good compliance to noninvasive ventilation and reducing of pulmonary congestion.

• The expected sedation scores (Ramsay score 2-3) will be achieved in all of the patients taking morphine, midazolam or dexmedetomidine

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 year with a clinical diagnosis of ACPE with severe dyspnea and anxiety.
* Patients able to verbally acknowledge the risks in receiving midazolam, morphine or dexmedetomidine.-

Diagnosis of ACPE was defined by the association of sudden onset of dyspnoea, the presence of bilateral rales on auscultation, respiratory rate \>25 breaths/min and pulse oxygen saturation \<90% in room air. diagnosis will be confirmed by echocardiography and lung ultrasound

Exclusion Criteria:

* Patients with history of asthma, severe stenotic valvular disease. • Cardiovascular collapse or an impaired level of consciousness (Glasgow Coma Scale score of ≤8 points).

Immediate indication for intubation.

• Suspicion of ST-segment elevation, acute coronary syndrome needing interventions.

• Known severe liver or renal disease, pneumonia, poor chance of survival due to a pre-existing condition.

• Psychiatric disorders.
Evaluation of Different Analysis Methods for Circulating Tumor Cells, Circulating Endothelial Cell, and Circulating Tumor DNA in Patient Followed for a Tumoral Pathology

Fifteen cohorts will be opened. Each cohort will explore one analysis method and/or tumoral type. Up to 50 patient can be included into each cohort.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or more
* Performance status from 0 to 4
* Patient treated followed for histologically confirmed solid tumor type of any of these localization : breast, prostate, uterus, ovary, colon, lung, head and neck, melanoma.
* Informed consent form signed.

Exclusion Criteria:

* Patient with history of other invasive cancer within 5 years.
* Patient treated for any non-invasive cancer
* Patient individually deprived of liberty or placed under the authority of a tutor
* Geographical condition potentially preventing compliance with the study protocol.
D-cycloserine: A Novel Treatment for Gulf War Illness (GWDCS)

The purpose of this study is to investigate the efficacy of d-cycloserine (DCS) treatment for Gulf War Illness (GWI). Gulf War veterans with Gulf War Illness experience numerous chronic health symptoms, including cognition and fatigue, which reduces their quality of life. Gulf War veterans are in urgent need of novel treatment plans to tackle elusive symptomatology of Gulf War Illness. By using the literature of previous studies, the investigators have chosen to investigate d-cycloserine as a possible candidate for treating GWI, specifically cognitive symptoms. DCS has been shown to reduce neuroinflammation, regulate glutamate levels, and improve synaptic functioning in key areas of the brain.

Our study is a pilot study for the novel treatment of d-cycloserine to treat GWI. Our study will consist of two experimental groups of equal size (n=28): DCS treatment group and a placebo group. Participants will be randomized into either group; with a double blind study design. Participants will be instructed to self-administer their treatment pills once per day for 28 days. There will be a total of 6 study visits that will include medical and neuropsychological assessment. The first visit will be for establishing eligibility and baseline functioning. Three visits (visits 2-4) will occur during the medication trial (day 1, day 2 and two weeks into medication/placebo). Visit 5 will occur around the time medication/placebo is finished. Visit 6 (follow up) will occur one month after medication/placebo is complete.

Eligibility Criteria:
Inclusion Criteria:

* Veterans of the 1991 Gulf War, male or female
* Physical examination and laboratory findings within normal limits
* Willingness and ability to participate in the informed consent process and comply with study protocols
* Symptom criteria: Meets Gulf War Illness criteria with the cognitive symptom domain being present. Veteran does not have medical exclusions for Gulf War Illness

Exclusion Criteria:

* Veteran lacks the capacity to provide consent during the informed consent process
* Veteran has the one of the following medical exclusion conditions and/or has been active or received treatment within the past 5 years: Cancer (except nonmelanoma skin cancer), diabetes (not well managed), seizure disorder, heart disease (except hypertension), liver disease, kidney disease, Lupus, multiple sclerosis, stroke, chronic infectious disease, immune disorder/immunosuppression
* Veteran has a history of a major psychiatric or central nervous system disorder that can affect cognitive function (ie. epilepsy, brain tumor, Parkinson's Disease)
* Veteran has been hospitalized in the past 5 years for depression, PTSD, alcohol or drug dependence
* Veteran has current suicidal ideation or current alcohol or drug dependence
* Pregnant women, lactating women, women who are breastfeeding, or women of childbearing potential who are not using medically accepted forms of contraception
* Veteran is active duty personnel
Effects of Smartphone Use on Posture, Pain, Function and QoL

The aim of the study is to determine the effects of the use of smartphone on the neck and shoulder posture, pain, and functions, and the quality of life in young adults. The sample of the study consists of university students. According to the scores they got from the Smartphone Addiction Scale-Short Version, all participants will be divided into two groups. The neck and shoulder posture, pain, and functions, and the quality of life will be compared between the two groups.

The study will include 106 university students who are 18-25 years old. According to the scores they got from the Smartphone Addiction Scale-Short Version, all students will be divided into two groups as Excessive Smartphone Use Group and Non-excessive Smartphone Use Group, both consisting of 53 participants. Participants whose scores are higher than 30 will be included to the Excessive Smartphone Use Group, and whose scores are 30 or less will be included to the Non-excessive Smartphone Use Group. In the assessment of pain level, the Visual Analogue Scale will be used. Functional levels of the neck and shoulders will be evaluated with the Copenhagen Neck Functional Disability Scale and the Shoulder Disability Questionnaire. World Health Organization Quality of Life Instrument-Short Form will be utilized to assess the quality of life. Postural analyzes of the participants will be fulfilled with the New York Posture Rating Chart. All scores will be evaluated by comparing between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* To be willing and volunteer to participate in the study
* To be between 18 and 25 years old
* To have been using smartphone for more than 1 year

Exclusion Criteria:

* To have any health problem history or diagnosed pathology related with the neck or shoulder regions
* To have any history of trauma or surgery related to the neck or shoulder regions
* To have received any medical attention or treatment in the last six months because of a health problem related to neck or shoulder
* To have any diagnosed neurological problem