cyrilzakka/clinical-trials huggingface dataset:
Efficacy of a Supervised Physical Therapy Rehabilitation Program vs Nonsupervised in Non-specific Low Back Pain

This study compares the efficacy of a supervised rehabilitation program vs a non supervised rehabilitation program on pain, disability, quality of life and kinesiophobia in patients with non-specific low back pain.

Low back pain is one of the most common problems of population, being a priority for health systems. It has got a high prevalence and recurrence, affecting in a social and economic way, and, it is one of principal causes of laboral absenteism. A randomized clinical trial will be conducted comparing a supervised physical therapy rehabilitation program vs a non supervised rehabilitation program.

Objective: to compare the efficacy of a supervised rehabilitation program vs a non supervised rehabilitation program in patients with non-specific low back pain.

Methods: Sixt-four subjects with chronic non-specific low back pain will be assigned to supervised rehabilitation program or non supervised rehabilitation program during 4 weeks (5 sessions/week). Outcomes measures will be the following: disability, pain intensity, fear of movement, quality of life, McQuade Test, and lumbar mobility flexion.

Eligibility Criteria:
Inclusion Criteria:

* Chronic non-specific low back pain persisting ≥ 3 months.
* Age between 18 and 65 years.
* A score ≥ 4 in Roland Morris Disability Questionnaire.
* Not currently receiving physical therapy.

Exclusion Criteria:

* Presence of lumbar stenosis.
* Presence of clinical signs of radiculopathy.
* Diagnosis of spondylolisthesis.
* Diagnosis of fibromyalgia.
* Treatment with corticosteroid or pharmachological medication within the paset 2 weeks.
* A history of spinal surgery.
* Central or peripheral nervous system disease.
Impact of Canadian Haskap Berry Powder on Hypertension and Acuity in Women's Health

Haskap berries are rich in cyanidin-3-O-glucoside (C3G), which has been shown in vitro to enhance endothelial function. Previous clinical studies suggest haskap berry supplementation may improve cognition, mood, blood pressure, and athletic performance, but research is limited. This trial aims to contribute to the growing body of evidence on the effects of haskap berry supplementation.

The trial is a 2-period, randomized, double-blinded, cross-over design lasting 16 weeks. During the first period (weeks 0-6), participants will receive either haskap berry powder or a control powder. A 4-week washout period follows (weeks 7-10), where no powder is consumed. In the second period (weeks 11-16), participants will receive the powder they did not consume in the first period.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent to participate in the trial;
* Biological female who is at least 35 years of age;
* A waist circumference of at least 35 inches;
* Average systolic blood pressure between 120 and 150 mmHg;
* Average diastolic blood pressure between 75 and 100 mmHg

Exclusion Criteria:

* Biological male;
* Gluten allergies, celiac disease, or gluten intolerance;
* Allergic to berries;
* Receiving chemotherapy;
* Use of medications containing pseudoephedrine or other anti-inflammatory drugs, and the use of cyclosporine or tacrolimusin;
* Cardiovascular diseases including stroke, congestive heart failure, myocardial infarction, unstable angina pectoris, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, and transient ischemic attack within six months before screening;
* Inability to consume treatment product;
* Inability to provide written informed consent;
* Any of the following visual impairments: diabetic retinopathy, age-related macular degeneration, glaucoma, or cataract;
* Risk of epileptic seizures;
* Any form of motor impairments;
* Any visual impairments, uncorrected vision problems, eye disorders, or injuries
* Any medical condition, uncontrolled systemic disease, or concurrent illness that would hinder study compliance or jeopardize the participant's safety, based on the investigator's opinion
Clinical Evaluation of T.R.U.E. TEST in Children and Adolescents

Open, prospective, single-site, non-randomized study of the efficacy and safety of T.R.U.E. TEST allergens in children and adolescents ages 6-18.

Three T.R.U.E. TEST panels (1.1, 2.1 and 3.1) containing 28 allergens and a negative control will be applied to the skin on the subject's back and worn for approximately 48 hours. Patch test site skin reactions will be evaluated at days 2, 3 (+1), 7 and 21 following panel application

Eligibility Criteria:
Inclusion Criteria:

* Symptoms and history potentially consistent with allergic contact dermatitis based on symptoms and clinical history (i.e., subjects are visiting the clinic/physician to diagnose, treat or resolve this condition).
* Children and adolescents 6 to 18 years of age, and in general good health.
* Adolescent females 15 years of age or older (or with menarche) must consent to a urine pregnancy test; urine test results must be negative for study inclusion.
* Informed consent must be signed and understood by subject. If underage, informed consent must be signed and understood by parent or legal guardian, consistent with all institutional, local and national regulations.

Exclusion Criteria:

* Topical corticosteroid treatment during the last 7 days on or near the test area.
* Systemic treatment with corticosteroids or other immunosuppressive during the last 7 days.
* Subjects currently receiving (or received during the previous 3 weeks) other investigational drugs, treatments or devices, or participating in another clinical study.
* Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks.
* Acute dermatitis outbreak or dermatitis on or near the test area on the back.
* Subjects unable to comply with activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity).
* Subjects unable or unwilling to comply with multiple return visits.
* Female subjects 15 years of age (or with onset of menarche) and older unable to consent to a urine pregnancy test, or those with a positive pregnancy test.
ED Recovery Course Online RCT

The purpose of this study is to examine whether the Eat Breathe Thrive (EBT) Yoga for Eating Disorder Recovery online course is effective in supporting eating disorder recovery.

We will conduct a block randomized controlled trial (RCT) comparing an intervention group and a waitlist control group. Participants in the intervention group will complete the Eat Breathe Thrive (EBT) Yoga for Eating Disorder Recovery online course. This course will be led by certified facilitators via Zoom and offered over the course of four weeks, comprising one two-hour session per week. The course will continue to recruit and enroll participants until sufficient power is reached for the study. At Pretest, Posttest 1, Posttest 2, and three-months Follow-Up, participants will complete a series of self-report measures (see point 12.3). Participants in the waitlist control group will only be engaged in the study assessment procedures. However, they will be given the opportunity to take part in the Yoga for Eating Disorder Recovery online course that was delivered to the intervention group, once Posttest 1 has been completed by both groups.

Eligibility Criteria:
Inclusion Criteria:

* Participants included in the study sample will be people between the ages of 18 and 65, who self-identify as women, are not pregnant, are willing to sign the consent form, are English-speakers, have not taken any EBT course before, and self-identify as recovering from an eating disorder.

Exclusion Criteria:

* The study will utilize the EBT participant application for screening (see attached). Further, those excluded will be people who do not self-identify as women, who are below 18 years old or above 65, pregnant, unable/refuse to sign the consent form, non-English speakers, have taken EBT before, and who do not self-identify as recovering from an eating disorder. Further, those who have suicidal ideations and engage in self-harm behaviors cannot be included.
Validity and Reliability of the Turkish Version of the Functional Shoulder Score

The aim of this study is to determine the validity and reliability of the Turkish version of the Functional Shoulder Score in Turkish patients with subacromial impingement syndrome (SIS).

The original form of the Functional Shoulder Score will be translated into Turkish by two Turkish mother tongue translators who also speak English in advanced level. Then these translations will be combined into one translation and translated back to English. The pre-final version will be composed and tested on a group of patients with SIS. If necessary, readjustments will be made, and the validity of the final version will be investigated in 116 patients with SIS. Additionally, for the test-retest reliability, 59 patients will fill out the questionnaire again after 3-7 days.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of subacromial impingement syndrome (Michener et al, 2009)
* To read and understand Turkish

Exclusion Criteria:

* 50% limitation of passive shoulder range of motion in ≥ 2 planes of motion
* Glenohumeral instability
* Fracture or surgery history in the shoulder
* Another diagnosis that may affect shoulder function (frozen shoulder, primary shoulder arthritis, inflammatory/ neoplastic/neurological conditions, cervical spine induced pain)
* Systemic musculoskeletal disease
BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy

The purpose of this study is to assess functional outcomes post operatively after the use of BioDFence® G3 during robotic radical prostatectomy.

The purpose of this study is to build on our experience of amniotic membrane use in Robotic Assisted Radical Prostatectomy for prostate cancer, we aim to evaluate clinical outcomes related to the use of BioDFence® G3; a tri-layered amniotic membrane. BioDFence® G3 is regulated by the FDA as a 361 HCT/P for use from head to toe as a tissue barrier for soft tissue repair and as a wound covering.

For the purpose of this study BioDFence® G3 will be placed on the neurovascular bundles by the surgeon during the robotic assisted radical prostatectomy procedure that the participant has elected as their primary treatment for prostate cancer. The potential benefits that will be assessed are an earlier return of potency after surgery as evidenced by The Sexual Health Inventory for Men (SHIM) questionnaire score and self-reported sexual function and secondarily looking at continence outcomes measured by The American Urological Association (AUA) questionnaire form and self-reported urinary function.

Eligibility Criteria:
Inclusion Criteria:

1. Male subjects between the ages 40-70.
2. Primary diagnosis of prostate cancer requiring surgical intervention
3. Have a willingness to comply with follow-up requirements.
4. Have ability to provide full written consent.
5. Primary diagnosis of untreated with clinically localized prostate cancer with Gleason score of 6, or 7.
6. Planned elective radical prostatectomy with bilateral full nerve sparing technique.
7. Patients who currently have a pre-operative SHIM \> 19

Exclusion Criteria:

1. Has signs or symptoms of any other disease which could result in allograft failure or has experienced graft failure in the past.
2. Has any condition(s), which seriously compromises the subject's ability to participate in this study or has a known history of poor adherence with medical treatment.
3. Has comorbid conditions that can be confused with or can exacerbate the condition of erectile dysfunction, including:

   1. Diabetes Type I or Type II
   2. Advanced atherosclerotic vascular disease
4. Is unable to sign or understand informed consent.
5. Is unable to comply with penile rehabilitation, including oral 5-phosphodiesterase inhibitor.
6. Has a documented medical history of drug or alcohol abuse within last 12 months.
7. Has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
8. Known sensitivity to glutaraldehyde or ethanol.
9. Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
10. Has had prior hormonal therapy such as Lupron or oral anti-androgens.
11. Living outside of United States
12. Partial nerve sparing technique used during Radical Prostatectomy
Safety and Pharmacokinetics of KBPA-101 in Hospital Acquired Pneumonia Caused by O11 Pseudomonas Aeruginosa

The objectives of this open study are to assess the safety, tolerability, pharmacokinetics and clinical outcome of patients who have HAP caused by Pseudomonas aeruginosa serotype O11 after three separate administrations of KBPA-101 every third day in addition of standard of care antibiotic treatment.

Hospital acquired pneumonia (HAP) is a pneumonia occurring 48 hours or more after hospital admission. HAP occurs in patients on conventional hospital wards and in intensive care units (ICU), some of them associated to mechanical ventilation, known as Ventilator Associated Pneumonia (VAP). VAP is the most common infection on intensive care units representing 82% of HAP cases. Pseudomonas aeruginosa is one of the most frequent pathogens involved in ICU-HAP and despite of adequate treatment its crude mortality remains as high as 70% of the cases.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age
* Patients under intensive care management with hospital acquired pneumonia
* Microbiological diagnosis of P. aeruginosa serotype O11 HAP by lower respiratory tract specimen (BAL or miniBAL) and presence of a new or progressing pulmonary infiltrate, plus one of the three following criteria: a) fever greater than 38ºC, b) WBC greater than 10,000/mm3, or c) purulent sputum
* In non-intubated patients confirmed microbiological diagnosis of P. aeruginosa serotype O11 HAP by endotracheal aspirate (ETA) and modified clinical pulmonary infection score (CPIS) higher than 6 points
* Patient is expected to survive longer than 72 hours
* Written informed consent provided by the patient or by the relatives or the designated trusted person

Exclusion Criteria:

* Use of any investigational drug within 30 days preceding the first dose of KBPA-101, or planned use during the study and safety follow-up periods
* Existence of any surgical or medical condition that might render the patient unduly susceptible to possible toxicity from the monoclonal antibody, including septic shock with unstable hemodynamics,
* Patients with a known complement deficiency associated with systemic lupus erythematosus, paroxysmal nocturnal hemoglobinuria, hereditary angioedema, membranoproliferative glomerulonephritis, collagen vascular disease, autoimmune hepatitis, primary biliary cirrhosis, scleroderma, or recurrent Neisserial infections
* Confirmed Human Immunodeficiency Virus (HIV) infection
* Transplant patients and/or simultaneous treatment with systemic immuno-suppressive drugs.
* Patients with a known liver function deficiency, e.g. associated with liver cirrhosis (Child Pugh B or C) or acute hepatitis
* Administration of poly- or mono-immunoglobulins within the three months preceding the first dose of study drug or planned administration during the study period
* Neutropenia
Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications

The objective of the study is to investigate the natural history of patients with a temporary ileostomy and to assess the effect of Teduglutide in reducing morbidity, hospital readmissions and post reversal complications.

This is a prospective, controlled, randomized, double blind study. A total of 36 subjects will be enrolled into the study. Subjects will be randomized to receive Teduglutide or Placebo for 12 weeks or until the ileostomy is reversed. Teduglutide or placebo will be administered via a daily subcutaneous injection into the abdomen or thigh. The sites will be rotated with each injection. If adverse effects develop the subjects will be permitted to hold drug administration for a maximum of 5 days in total during the 12-week study.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are undergoing temporary ileostomy (loop or end ileostomy) regardless of the indication or technique used (open or laparoscopy) as part of their regular standard of care
* Age- 18-80 years old
* Normal routine laboratories (CMP, CBC, CRP, amylase, lipase)
* Permitted medications will include biologicals which dose has not been changed for \> 6 months, and immunosuppressant therapy which dose has not been changed for 3 months (i.e. codeine sulfate, loperamide, or Lomotil)

Exclusion Criteria:

* Emergency need for ileostomy
* Pregnant or nursing
* Malnutrition or requiring parenteral or enteral nutrition
* Known intestinal obstruction, stricture, or adhesions that would predispose the patient to the development of intestinal obstruction, perforation, hemorrhage, or intestinal abscess
* Intestinal fistulas or abscess proximal to the ostomy
* Small bowel resection greater than 50 cm.
* Clinically significant cardiovascular, renal, pulmonary, endocrine, immunologic, dermatology, neurological or psychiatric disorders
* Cholelithiasis or pancreatitis
* Family history of colorectal cancer or familial polyposis
* Cancer in the last 5 years
* History of HIV, Hepatitis B or C, or other acute systemic or intestinal infections requiring antibiotics
* Use of GLP1 analogues which may increase the risk of acute pancreatitis
* Treatment of Octreotide
A Study of LY3192767 in Healthy Participants

The main purpose of this study is to investigate the side effects related to LY3192767 when given as an injection under the skin to healthy participants. Blood tests will be done to check how much LY3192767 is absorbed into the bloodstream, how long it takes for the body to get rid of it, and how it affects blood sugar levels. The study has two parts: Part A and Part B. Each participant will enroll in one part. For each participant, Part A will last up to about 32 days after last dose and Part B will last up to about 49 days after last dose. Screening must be completed prior to study start.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy males or females, as determined by medical history and physical examination
* Have a body mass index (BMI) of \>18.5 and \<30.0 kilogram per square meter (kg/m²), inclusive

Exclusion Criteria:

* Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
* Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed
* Have participated as a participant in a first-in-human study within 90 days of the initial dose of study drug
* Have known allergies to insulin, heparin, or related drugs, or history of relevant allergic reactions of any origin
* Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, chronic inflammatory disease, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
Does the Ingestion of Mycoprotein Elicit an Optimal Anabolic Response in Resting and Exercised Skeletal Muscle?

The present study will seek to quantify the muscle protein synthetic response to mycoprotein feeding, comparing it to milk protein as a gold standard and heavily researched positive control


Eligibility Criteria:
Inclusion Criteria:

• BMI between 18 and 30 -

Exclusion Criteria:

* Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes)
* Any diagnosed cardiovascular disease or hypertension.
* Elevated blood pressure at the time of screening (e.g. blood pressure of ≥140/90mmHg).
* Chronic use of any prescribed or over the counter pharmaceuticals.
* A personal or family history of epilepsy, seizures or schizophrenia.
* Anyone with previous motor disorders.
* An allergy to mycoprotein / Quorn, penicillin, or milk.
NOCDURNA PASS Study Using Registries in Denmark, Germany and Sweden

A study using medical records to evaluate safety issues for the NOCDURNA drug using national register data from Denmark and Sweden, and a health care register covering parts of Germany.


Eligibility Criteria:
Inclusion Criteria:

* Usage of NOCDURNA recorded as dispensations from drugstores in adults or or usage of drugs for LUTS.

Exclusion Criteria:

* Multiple dispensation of NOCDURNA on the same day or treatment with vasopressin 6 months before study start.
Hypnosis for Patients Treated With Adjuvant Chemotherapy for Breast Cancer(HYPNOVAL)

The main objective is to assess the feasibility of an intervention based on medical Ericksonian hypnosis as a complementary therapy in patients treated with surgery after a diagnosis of breast cancer, followed by an indication of adjuvant chemotherapy and radiotherapy

In the field of management of cancer, many approaches have been used since tens of years, particularly in regard of pain management, both in achieving surgical or invasive procedures in the pain induced by the disease itself. the investigators owe the first description in 1829 Chapelin and col who used hypnosis in a patient with breast cancer in which a mastectomy should be performed. Meta-analysis (2000) showed the positive impact of analgesia obtained through hypnosis on the perception of pain intensity. In children in whom regular venous punctures is performed, using hypnosis seems indisputable on the management of anticipatory anxiety, leading to a better experience of the act itself. Regarding the nausea and vomiting induced by chemotherapy, numerous studies are old, not always randomized and performed often before the era of the setrons; but seems favorable impact on anticipated nausea and vomiting, the updated studies should emerge on the issue of delayed emesis which remain a serious adverse event and not completely resolved. Mark to improve the EORTC validated tools of quality of life measurement widely used for example in ovarian cancer.

The impact of hypnosis on the quality of life or the side effects of treatment or rehospitalization for toxicity remains controversial (Judson, 2011). A meta-analysis combining the tests carried out before and after the era of setrons (Richardson, 2007) concluded that the effectiveness of the anticipated nausea and vomiting.

In this context,the investigators proposed to conduct a feasibility study to evaluate the role and impact of medical Ericksonian hypnosis on acute and delayed adverse event (incl nausea and vomiting) in female patients treated by adjuvant chemotherapy for breast cancer.

The main objective is to assess the feasibility of an intervention based on medical Ericksonian hypnosis as a complementary therapy in patients treated with surgery after a diagnosis of breast cancer, followed by an indication of adjuvant chemotherapy and radiotherapy

Eligibility Criteria:
Inclusion Criteria:

* • Female, age \> 18 years-old

  * Without previous practice of hypnosis
  * Patient with diagnosis of breast cancer
  * Patient receiving an adjuvant chemotherapy for at least 3 months with an indication of radiotherapy after chemotherapy
  * Patient accepting the principle of the study with a signed written informed consent
  * Patient affiliated to French Social Security

Exclusion Criteria:

* • Male

  * Age \< 18 years
  * Patient refusing hypnosis
  * Pregnancy, breast-feeding, or lack of effective contraception in female patients with reproductive potential.
  * Patient with psychological or mental disorders under psychotropic treatments (lithium, neuroleptics)
  * Not ability to speak and read French, deaf and/or mute