cyrilzakka/clinical-trials huggingface dataset:
Soft Tissue Mobilization Versus Therapeutic Ultrasound for Subjects With Neck and Arm Pain

The purpose of this study is to investigate effects of soft tissue mobilization versus therapeutic ultrasound in subjects with neck and arm pain who demonstrate neural mechanical sensitivity.

To investigate the immediate effects of soft tissue mobilization (STM) versus therapeutic ultrasound (US) in patients with neck and arm pain who demonstrate neural mechanical sensitivity. Twenty-three patients with neck and arm pain and a positive upper limb neurodynamic test (ULNT) were randomly assigned to receive STM or therapeutic US during a single session. Outcome measures were collected immediately before and after treatment, and at 2-4 day follow-up. Primary outcomes were the Global Rating of Change (GROC), range of motion (ROM) during the ULNT, and pain rating during the ULNT. Secondary measures included the Neck Disability Index (NDI), Patient-Specific Functional Scale (PSFS), Numeric Pain Rating Scale (NPRS), and active range of shoulder abduction motion combined with the wrist neutral or wrist extension.

Eligibility Criteria:
Inclusion Criteria:

1. Active movement dysfunction that could be related to mechanical sensitivity of the neural structures of the upper limb. (i.e. painful shoulder abduction with elbow extension that is limited more when the wrist is extended than when the wrist is in neutral.)
2. Positive response to upper limb neural provocation testing (ULNT 1) (see description below for details)
3. Tenderness to palpation over the cervical nerve trunks, brachial plexus, or along the median nerve.
4. Tender points or taut bands in the muscles of the upper quadrant including the scalenes, cervical paraspinals, trapezius, deltoid, pectoralis major or minor, rotator cuff, biceps, triceps, coracobrachialis, brachialis, radiobrachialis, pronator teres, supinator, forearm extensor, forearm flexor, pronator quadratus, and hand intrinsic muscles.

Exclusion Criteria:

1. Red flags noted in the medical screening questionnaire such as tumor, fracture, history of metabolic disease, prolonged history of corticosteroid use.
2. Signs of central nervous system involvement such as hyper-reflexia (exaggerated response to deep tendon reflex testing), unsteadiness during gait, ataxia, disturbed vision, nystagmus, altered taste, positive Babinski's or Hoffman's reflexes.
3. Cervical spine surgery within the last 3 months.
4. Litigation associated with their neck and/or upper limb pain.
5. Insufficient English language skills to complete the questionnaires and follow-up instructions.
6. Inability to complete the treatment and follow-up schedule.
7. Current pregnancy.
The Effect of tDCS in Patients With Moderate to Severe Major Depressive Disorder

Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Patients will be randomized to receive either real or sham-tDCS as well as anti-depressant drugs. tDCS will be applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Patients will visit the hospital to get tDCS administrations 5 days a week for 2 weeks. They will be evaluated every 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Has a diagnosis of a major depressive disorder as confirmed by the SCID-IV and MINI (without psychotic features)
* Greater than 22 points of Montgomery-Asberg Depression Rating Scale
* Aged 19 to 65.
* Has provided informed consent

Exclusion Criteria:

* Has other mental disorders diagnosed by Axis-I, except major depressive disorder (However, subject who is diagnosed as both major depressive disorder as well as anxiety disorder can participate the study.)
* History of suicidal attempt in the last 6 months
* Diagnosed with bipolar or psychotic major depressive disorder
* Diagnosed with other depressive disorders: dysthymic disorder, and depressive disorders that are not elsewhere classified.
* Has hypersensitivity to sertraline ingredients
* A score of 5 or greater for the question #10 in MADRS
* Diagnosed with closed angle glaucoma or has a history of glaucoma.
* History of participation in other clinical trials within 30days.
* A major and/or unstable medical or neurologic illness
* Currently taking substances that contain sertraline, mono amine oxidase inhibitor, or pimozide
* Pregnant or has a positive pregnancy serum test.
The Effects of Progressive Clinical Pilates Exercises Applied as 2 Different Ways in Fibromyalgia

The aim of this study is to compare the effects of progressive clinical Pilates exercises applied as group under the supervision of a physiotherapist and home exercise programs on pain level, physical condition, functional status, psychosocial status and quality of life in individuals with fibromyalgia between the ages of 20-50.

After the voluntary individuals with Fibromyalgia (FM) who meet the inclusion criteria are evaluated, they will be randomly divided into two groups: exercise group and home exercise group.

The same clinical Pilates program will be applied to both groups at the same dosage. Evaluations and treatment will be applied to both groups by the same physiotherapist. Individuals will perform the exercises 10 repetitions, 3 days a week, for 6 weeks. The exercise program will be progressed as basic stabilization exercises in the first 3 weeks, advanced stabilization exercises in the last 3 weeks, as recommended in the literature, and a 30-second rest will be given between sets. For the home exercise group, all exercises will be shown and it will be ensured that they are performed correctly. Patients will be given an illustrated and descriptive exercise program brochure containing information about exercise position, number of repetitions, contraction duration, rest time between sets, frequency, and an exercise diary for exercise tracking.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer individuals between the ages of 20-50
* Diagnosed with fibromyalgia according to the American College of Rheumatology criteria
* Pain level 3 and above according to visual analogue scale.
* Individuals who are sedentary (who have not engaged in physical activity at least 3 days a week in the last 3 months) will be included in the study.

Exclusion Criteria:

* Having additional rheumatic disease
* Using NSAIDs and antidepressant drugs
* Individuals with orthopedic, neurological and cardiopulmonary diseases that prevent them from exercising
* Pregnant women
* Malignancy
* Individuals with uncontrolled systemic diseases (diabetes, systemic arterial hypertension, thyroid dysfunction, neurological, cardiorespiratory, musculoskeletal problems, etc.)
A Study to Compare Daratumumab, Bortezomib, and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Chinese Participants With Relapsed or Refractory Multiple Myeloma

The primary purpose of this study is to compare the efficacy of daratumumab when combined with Velcade (bortezomib) and dexamethasone (DVd) to that of Velcade and dexamethasone (Vd), in terms of progression free survival (PFS) in Chinese participants with relapsed or refractory multiple myeloma (MM).


Eligibility Criteria:
Inclusion Criteria:

* Documented multiple myeloma (MM) as defined by the criteria: monoclonal plasma cells in the bone marrow greater than or equal to (\>=) 10 percent (%) at some point in the participant's disease course or presence of a biopsy-proven plasmacytoma
* Received at least 1 prior line of therapy for MM
* Documented evidence of progressive disease (PD) based on investigator's determination of response as defined by the International Myeloma Working Group (IMWG) criteria on or after their last regimen
* Achieved a response (partial response \[PR\] or better based on investigator's determination of response by the IMWG criteria) to at least 1 prior regimen
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2

Exclusion Criteria:

* Received daratumumab or other anti-CD38 therapies
* Refractory to Velcade, or another proteasome inhibitor (PI), like ixazomib and carfilzomib (ie, participant had progression of disease while receiving Velcade therapy or within 60 days of ending Velcade therapy, or another PI, like ixazomib and carfilzomib, etc)
* Intolerant to Velcade (that is \[ie\], discontinued due to any adverse event while on Velcade treatment)
* Planning to undergo a stem cell transplant prior to progression of disease on this study, that is ie, these participants should not be enrolled in order to reduce disease burden prior to transplant
* History of malignancy (other than MM) within 3 years before the date of randomization
Emergency Use of OCR-002 in Acute Liver Failure (ALF)

This study provides emergency use of the unapproved study medication in ALF patients with acute liver failure who are not responding to standard of care.

This is an open-label study in patients diagnosed with ALF who are not responding to the institution's standards of care. Standard of care may include, but is not limited to, administration of N-acetylcysteine, lactulose, hypothermia therapy, and consideration for orthotopic liver transplant.

Eligibility Criteria:
Inclusion Criteria:

* International Normalized Ratio (INR) ≥1.5 with encephalopathy in patient with no prior history of liver disease
* Venous ammonia level of ≥ 100 μmol/L

Exclusion Criteria:

* Patients who are pregnant
Hypertrophic Cardiomyopathy Symptom Release by BX1514M

Hypertrophic cardiomyopathy (HCM) is the most frequent genetic cardiac disease characterized by an asymmetric hypertrophic. In two third of patients, an obstruction to blood ejection is observed within the left ventricle which is named left ventricular outflow tract obstruction (LVOTO). This phenomenon can occur at rest or during exercise and is associated with symptoms such as dyspnea, dizziness or chest pain that can significantly limit day life adaptation. To now, medical or interventional treatments such as betablocacker, calcium blockers or septal alcoholisation or surgery present with a limited efficiency. Recent studies from investigators group revealed new concepts about the role of venous return to the LVOTO. Therefore the investigators hypothesis that BX1514M generating a venous vascular constriction, could improve symptoms of HCM patients by reducing LVOTO.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a typical or atypical hypertrophic cardiomyopathy (HCM) confirmed by imaging modalities (echo and MRI) and/or genetic tests or a relative history of HCM
* Left ventricular obstruction during exercise on treadmill (above 50 mmHg)
* Positive response to leg lifting test (obstruction reduction above 20 mmHg) at rest or in early recovery phase
* Daily symptoms as shortness of breath during exercise (NYHA2-3), non coronary chest pain, dizziness
* Correct ultrasound windows quality
* Sinus rhythm
* Optimal medical treatment
* For women, pregnancy test or contraception
* Written consent form obtained

Exclusion Criteria:

* Previous treatment by BX1514M
* Extra-cardiac pathology with life expectancy below than 1 year
* No capability of consent form written
* Pregnancy women
* Secondary hypertension hypertrophy, secondary valvular disease hypertrophy
* Permanent atrial fibrillation
* Severe ventricular arrhythmia without Implantable Cardioverter Defibrillator (ICD)
* Severe coronary disease
* Severe non stabilized hypertension
* Severe cardiopathy (ejection fraction below 40% or demonstrated elevated end diastolic pressure or pulmonary pressure above 60 mmHg)
* Bradycardia
* Narrow angle glaucoma
* Vascular prethrombotic diseases
* Vascular spams
* Thyrotoxicosis
* Pheochromocytoma
* Severe renal failure (\<30ml/mn)
* Patients at risk of urinary retention secondary to prostatic severe disease
* Raynaud's disease
* Non selective Monoamine Oxidase Inhibitors (MAOIs), iproniazid, nialamide or ephedrine, methylphenidate, phenylephrine, pseudoephedrine or digitalic
* Procedures modifying the peripheral venous return
* Participation to other research protocol
Trial of the Effect of Timing of Cholecystectomy During Initial Admission for Mild Gallstone Pancreatitis

Randomized trial of laparoscopic cholecystectomy with cholangiogram on admission versus after resolution of pain for mild gallstone pancreatitis.

The purpose of this study is to perform a single-center randomized trial to compare laparoscopic cholecystectomy with intraoperative cholangiogram (IOC) within 24 hours of presentation versus after clinical resolution during index admission for mild gallstone pancreatitis on clinical and patient-reported outcomes. Additionally, this study aims to determine patients' values and preferences that influence decision-making regarding treatment options for gallstone pancreatitis. Hypothesis: During index admission for mild gallstone pancreatitis, early cholecystectomy within 24 hours of presentation regardless of symptoms or laboratory values versus after clinical resolution results in a shorter 30-day total hospital length of stay.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of gallstone pancreatitis. Patients will be considered to have gallstone pancreatitis if they have:

  1. upper abdominal pain, nausea, vomiting, and epigastric tenderness
  2. absence of ethanol abuse
  3. elevated lipase level above the upper limit of normal (\>370 U/L)
  4. imaging confirmation of gallstones or sludge
* Low predicted mortality using the Bedside Index of Severity in Acute Pancreatitis (BISAP) -Diagnosis of mild pancreatitis (i.e.,no evidence of organ failure or local or systemic complications)
* Scheduled for laparoscopic cholecystectomy prior to discharge
* Lack of any very strong indicator for choledocholithiasis based on the American Society for Gastrointestinal Endoscopy (ASGE) guidelines
* Clinical stability as denoted by admission to a non-monitored floor bed.

Exclusion criteria

* Pregnancy
* Severe preexisting medical comorbidities precluding surgery, organ failure, local or systemic complications of acute pancreatitis
* Chronic pancreatitis
* Native language other than English and Spanish
* Patient refusal to participate
Measuring Concerns of Cancer Patients Referred to Complementary Medicine Treatment Integrated Within Oncology Service

In 2007, the Haifa and Western Galilee district of the CHS set out to test the feasibility of integrating complementary medicine (CM) within the CHS Oncology Service. In 2008, the CHS established the Integrative Oncology Program with the goal of addressing patient concerns and improving quality of life parameters during chemotherapy and advanced disease. The study hypothesis is that integrated medicine consultation and treatment provided within the oncology department may improve patients' concerns and well-being.

In 2007, the Haifa and Western Galilee district of the CHS set out to test the feasibility of integrating complementary medicine (CM) within the CHS Oncology Service. In 2008, the CHS established the Integrative Oncology Program with the goal of addressing patient concerns and improving quality of life parameters during chemotherapy and advanced disease. The study is purposed to assess concerns, needs and perspectives of patients referred to integrative consultation during chemotherapy and/or advanced cancer; to characterize social demographic and health parameters of patients who consult or avoid integrative medicine consultation; to document complementary medicine use prior and during consultation; to assess if complementary medicine consultation and treatment improve patient's concerns and well-being; and to assess oncology provider and integrative practitioner communications issues concerning integrative care.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cancer diagnosis receiving chemotherapy and/or surgical treatment who are referred by their oncology provider to complementary medicine consultation
* Age older than 18 years

Exclusion Criteria:

* Age younger than 18 years
Home Study of Subjects Who Have Completed a Previous Continuous Negative External Pressure (cNEP) Clinical Trial

This study is designed to determine whether subjects who were responders to cNEP during an overnight sleep lab titration in a previous clinical trial, Study SOM-012, will maintain a response throughout the night for up to two weeks in a home setting. It will also be determined whether two weeks of home use of cNEP is associated with any adverse events.


Eligibility Criteria:
Inclusion Criteria:

* must have completed study SOM-012 and been categorized as a "responder"
* the subject agrees to participation by signing an informed consent statement

Exclusion Criteria:

* medical or social circumstances have changed since participation in SOM-012 such that continued use of cNEP may provide questionable benefit or associated with increased risk
Effect of Low Level Laser Therapy on Pain Occurring After Insertion of an Orthodontic Device

Thus study consists of evaluating the effect of low level therapy on pain induced by insertion of an orthodontic device (the "quadhelix"). Each day during the first seven days post procedure, the level of pain will be reported on an analogic visual scale.

As secondary objectives, intake of antalgics and type of swallowed food (soft or tough) will also be daily registered.

Patient will be randomized into one of the 3 following arms :

* arm 1 (experimental) : administration of Low Level Laser Therapy just after insertion of the quadhelix.
* arm 2 (sham procedure) : material necessary to perform Low Level Laser Therapy will be installed but the laser will not be activated.
* arm 3 (no intervention): material necessary to perform Low Level Laser Therapy will NOT be installed

Eligibility Criteria:
Inclusion Criteria:

* Children aged between 8 and 15 years old who need to receive an orthodontic device ("quadhelix)
* informed consent form signed by parents who should be affiliated to French health insurance (french Social security)

Exclusion Criteria:

* malignant facial tumor
* not able to read or write correctly and thus not able to complete the questionnaire
* allergic or intolerant to paracetamol
* Informed consent not obtained
National Cooperative Growth Study (NCGS): A Post-marketing Surveillance Program for Nutropin, Nutropin AQ, Nutropin Depot, and Protropin

The purpose of this multicenter, open-label, observational, post-marketing surveillance study is to collect long term safety and efficacy information on growth hormone (GH) products: Protropin (somatrem for injection), Nutropin (somatropin for injection), Nutropin AQ (somatropin for injection), and Nutropin Depot (somatropin for injectable suspension) in the treatment of pediatric growth disorders for which GH is prescribed.


Eligibility Criteria:
Inclusion Criteria:

* Participants with open epiphyses
* Children of either sex who are treated with Nutropin Depot, Nutropin AQ, Nutropin, or Protropin for the treatment of growth failure
* Participants who are willing to keep follow up appointments throughout the study participation

Exclusion Criteria:

* Participants treated with a non-Genentech GH preparation
* Participants with closed epiphyses
* Participants with active neoplasia
Seroquel Switching Study: Feasibility of Switching Any Antipsychotic Treatment to Seroquel in Patients With Schizophrenia

The purpose of this study is to document the clinical benefit of quetiapine (Seroquel) sustained release (SR) after switching from another ongoing antipsychotic treatment, regardless of the reason for the switch.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility Criteria:
Inclusion Criteria:

* Patients who in their own and/or in the Investigator's opinion, consider ongoing antipsychotic treatment inadequate, because of insufficient efficacy and/or tolerability.
* Female patients of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation during the study.
* Able to understand and comply with the requirements of the study, as judged by the Investigator.

Exclusion Criteria:

* Meeting the criteria for any other (than schizophrenia) Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Axis I diagnosis, concomitant organic mental disorder or mental retardation.
* Substance abuse or dependence as defined by DSM-IV and not in full remission. A urine drug screen test will be performed. The Investigator will evaluate the results along with medical history to determine if the patient meets DSM-IV criteria for substance abuse or dependence.
* Risk of transmitting human immunodeficiency virus (HIV) or hepatitis B, via blood or other body fluids, as judged by the Investigator.
* Patients who, in the opinion of the Investigator, pose an imminent risk of suicide or a danger to self or others.
Safety and Efficacy Study of A0001 in Patients With the A3243G Mitochondrial DNA Point Mutation

This is a phase 2a, double-blind, placebo-controlled, single-center study. Twenty-one patients who qualify for the study will be randomly assigned to either active drug or placebo. The study will take place at Newcastle University. Patients will have a 66% chance of getting active drug. Patients will be required to take study treatment orally twice a day for 28 days. A baseline visit will occur within 21 days of screening visit. All patients will be followed for 1 week after completion of study or early withdrawal from the study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of neuromuscular symptoms due to the A3243G mitochondrial DNA point mutation
* PCR/ATP ratio of \<1.9 following the Cardiac MRS at screening

Exclusion Criteria:

* Any major illness not due to the A3243G mitochondrial DNA point mutation in the past three months or any significant ongoing chronic medical illness, especially significant central nervous neurological disease limiting capacity to carry out the study
* Use of any investigational product within the past 30 days
Alcohol and Health: Personalized Feedback

Heavy episodic drinking (HED) among college students remains a concern within the U.S., as rates of HED are still high in this population. Though a variety of brief motivational interventions for alcohol use in college students have demonstrated significant effects, these effects are often small and not consistently maintained over time. Personalized feedback interventions (PFIs) are a particularly promising approach, as these are often acceptable to college students, as well as low-cost, and easy to disseminate. Though presentation of interperson discrepancy via descriptive and injunctive norms has shown consistent effects within PFIs and received much attention in the literature, intraperson, or ideal-actual self discrepancies, has largely been ignored. Drawing from cognitive dissonance theory, self-regulation theory, and motivational interviewing, the current study aims to evaluate the efficacy of an alcohol PFI with a values component to incorporate ideal-self discrepancy into a typical intervention.


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age
* Must be able to speak and read English
* Must report consuming alcohol in a typical week over the past month

Exclusion Criteria:

* Must not deny drinking within the past month
* Non-English speaking
* Under the age of 18