cyrilzakka/clinical-trials huggingface dataset:
Task Specific Training for Advanced Multiple Sclerosis

The purpose of this study is to find effective physical therapy treatments for individuals who have severe multiple sclerosis. Physical therapy treatments for mild-to-moderate multiple sclerosis exists, however, very limited research has been done for physical therapy for severe multiple sclerosis (MS). In this study 10 participants diagnosed with severe MS will engage in 1-hour physical therapy sessions twice a week for 6 weeks to address limitations in standing, balancing, and bed mobility.

The purpose of this study is to investigate the feasibility, safety, and efficacy of task-specific physical therapy for persons with severe MS. The hypothesize for this study that a task-specific physical therapy program is safe, feasible, and effective in persons with severe MS.

Multiple studies have confirmed the effectiveness of task specific physical therapy for persons with MS. However,MS is a progressive disease which can lead to mild to severe disability and the studies examining the effectiveness of task specific therapy have only been conducted on persons with mild to moderate MS impairments. The small amount of research on physical therapy for persons with severe disability due to MS has only looked at the use of generalized conditioning exercises(1). Task specific therapy has been shown to be effective in persons with severe disability in non-MS neurologic disorders.(2) The effectiveness of task specific exercises on persons with severe MS not been studied. Based on the previous scientific evidence of the effectiveness of task-specific physical therapy in MS subjects with mild-to-moderate disability, there is strong scientific justification for conducting a trial of task specific therapy on persons with severe disability due to MS.

The results of this study will be presented at various conferences attended by physical therapists as well as other health care practitioners who specialize in MS care, including the American Physical Therapy Combined Sections Meeting, as well as the Consortium of Multiple Sclerosis Centers annual meeting. Additionally, upon completion of the study, we will submit a manuscript to the appropriate peer review journal.

Eligibility Criteria:
Inclusion Criteria:

1. definitive diagnosis of Multiple Sclerosis
2. Expanded Disability Status Scale (EDSS) of 7.0-8.0
3. Ability to read, understand , and sign an informed consent -

Exclusion Criteria:

1. evidence of MS exacerbation in the 4 weeks prior to starting the study
2. any orthopedic, cardiopulmonary, or non-MS neurologic symptoms that will interfere with their ability to participate in the study
Induction Chemotherapy Followed By Chrono-chemotherapy Concurrent With IMRT Of Locally Advanced NPC Clinical Study

Comparing induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy (chrono-chemotherapy group) with induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy (routine-chemotherapy group) in the treatment of locally advanced nasopharyngeal carcinoma, observing the adverse reaction and effects of two groups,expected chrono-chemotherapy group can achieve lower toxicity, improve the curative effect, for the treatment of nasopharyngeal carcinoma provides a more reasonable way.


Eligibility Criteria:
Inclusion Criteria:

1. Pathological diagnosis of early cure Ⅲ - Ⅳ stage of patients with advanced nasopharyngeal carcinoma (according to the 2010 UICC staging criteria, T3-4, N0-3), no evidence of distant metastasis (M0). A measurable tumor lesions;
2. Karnofsky score≥70;
3. Age 18-70 years old, male or female;
4. No major organ dysfunction; Normal bone marrow hematopoietic function (white blood cell ≥4．0×109／L，platelet≥100×109 /L. hemoglobin ≥100g/L)，normal liver function (total bilirubin、alanine aminotransferase、 aspartate aminotransferase ≤1.5 times the upper limit of normal)，normal renal function (creatinine ≤1.5 times the upper limit of normal) electrocardiogram does not affect the normal treatment;
5. To understand this study and sign informed consent form.

Exclusion Criteria:

1. A distant metastasis;
2. Patients with physical or mental illness, and researchers think that patients can't fully or adequately understand the possible complications of this study;
3. Pregnancy (confirmed by serum or urine β-HCG test) or between lactation period;
4. Serious complications, such as uncontrollable hypertension, heart function failure, diabetes, etc.; 5.Who had received radiation and chemotherapy.
Molecular Genetics of Schizophrenia

This study will create a DNA collection with blood samples from families with at least two siblings who have schizophrenia symptoms. This collection will help scientists identify genes that predispose people to schizophrenia.

Each site will recruit individuals in a large geographic area, and use efficient ascertainment strategies and assessment procedures in order to maximize the number collected. Subjects thought to have schizophrenia will be assessed by personal and family interviews and a review of medical records. Diagnoses will be made by consensus best-estimate procedures. Blood specimens will be obtained from all individuals with schizophrenia or schizoaffective disorder plus their available parents and also the control individuals. A clinical self-assessment will be administered to each control subject. The assessment will include validated self-assessments of lifetime major depression, anxiety disorders, and substance use, and self-reported history of bipolar or psychotic symptoms. Permanent cell lines will be created and DNA extracted at the NIMH-sponsored Center for Genetic Studies. At the end of the four-year project period, biological materials and blinded pedigree and clinical data will be made available to the scientific community for genetic studies of schizophrenia and related disorders. The control sample will, however, be released in a staggered fashion, twice during each fiscal year, to start during the 2nd year of recruitment. The informed consent for controls includes consent for specimens to be used in research on the genetics of any medical disorder. In years 3 and 4, we will undertake association analyses. Power analyses suggest that this study will have excellent power to detect loci associated with genes with relatively small etiologic effects. Data derived from this study will potentially have applications for the treatment and prevention of schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* Individuals thought to have schizophrenia or schizoaffective disorder, be the parent of such an individual, or be in the matched control group of unrelated individuals not thought to have schizophrenia or schizoaffective disorder

Exclusion Criteria:

* Unable to give informed consent to all aspects of the study
* Psychotic disorder judged to be secondary to substance use, psychotic disorder that appears to be secondary to a known medical or neurological disorder, or severe mental retardation
Prophylactic Antibiotic Use in Hernioplasty

The purpose of this study is to determine whether prophylactic antibiotic use in inguinal hernioplasty are effective in prevention of infectious complication.


Eligibility Criteria:
Inclusion Criteria:

* Primary inguinal hernia
* Elective surgery
* Must be older than 20 years of age
* Must not have any serious complication

Exclusion Criteria:

* Incarceration
* Recurrence
* Drug allergy
* Diabetes mellitus
* Malignant diseases
* Serious heart diseases
* Psychological diseases
* Pregnancy
* Have been medicated with corticosteroids
Therapeutic Strategy in Postmenopausal Women Using Osteoporotic Diagnostic Kits

The frequency of osteoporosis in Japan is increasing. Also, the frequency of osteoporosis-based fractures in postmenopausal women is increasing. Therefore, it is urgently required to improve osteoporosis. Life expectancy in Nagano prefecture is the longest in Japan, however, healthy life expectancy in Nagano is not very long in Japan. There are several problems in this issue from the medical site and the patient site. The aim of this study is, from the patient site, to increase the motivation of postmenopausal women for osteoporosis using osteoporotic diagnostic kit.


Eligibility Criteria:
Inclusion Criteria:

* Women, mainly postmenopausal women

Exclusion Criteria:

* Men
Phase II Study of Combined Modality Treatment in Primary Testicular Non-Hodgkin's Lymphoma

The primary objective assess the clinical activity of combination doxorubicin-containing chemotherapy plus monoclonal antibody anti-CD20 (Rituximab) plus intrathecal prophylactic chemotherapy and loco-regional radiotherapy in primary localised testicular DLCL and to assess the toxicity of this therapeutic strategy


Eligibility Criteria:
Inclusion Criteria:

1. age = 18 years.
2. ECOG performance status 0-2
3. Histologically proven primary testicular CD20-positive diffuse large B-cell non-Hodgkin's lymphoma, untreated
4. Ann Arbor stage IE or IIE. Bilateral testicular involvement at presentation will not be considered stage IV. In these patients the final Ann Arbor stage will be determined by the extent of nodal involvement.
5. Bidimensionally measurable or evaluable disease. Patients who have had all disease removed by surgery are eligible.
6. Adequate bone marrow reserve (ANC \> 1.000/L, Plt \> 100.000/L)
7. Cardiac ejection fraction ≥ 50% by MUGA scan or echocardiography
8. No previous therapy with monoclonal antibody anti-CD20.
9. No psychiatric illness that precludes understanding concepts of the trial or signing informed consent
10. No other major life-threatening illnesses that may preclude chemotherapy
11. Have given written informed consent prior to any program-specific screening procedure, with the understanding that the consent may be withdrawn by the patient at any time without prejudice

Exclusion Criteria:

1. impairment of renal function (creatinine \> 2 mg/dl) or liver function (bilirubin \> 2 mg/dl) unless due to lymphoma involvement
2. HIV positive patients
3. evolutive malignancy within 5 years with the exception of localized non-melanomatous skin cancer
Belatacept Compared to Tacrolimus in Deceased Donor Renal Transplant Recipients

The main purpose of this study is to ﬁnd out whether treatment to prevent kidney rejection with belatacept in presence of Thymoglobulin induction and withdrawal of steroids will result in less delayed graft function or "sleepy kidney" after transplant than that seen in patients who get tacrolimus as their main drug to prevent rejection instead of belatacept. The investigators will also look at whether patients who get belatacept have the same, lesser or more problems that those who get tacrolimus.

New York Presbyterian Hospital-Columbia University Medical Center (NYPH-CUMC) performs nearly 250 renal transplants annually; of these approximately half are recipients of a variety of deceased donor kidneys, usually with cold ischemia time (CIT) \>24 hours leading to an approximate incidence of delayed graft function (DGF) of 50%. The main focus of this study will be to determine whether initial immunosuppression with belatacept with Thymoglobulin induction will result in lower incidence and/or more rapid disappearance of DGF than that observed in patients who receive tacrolimus based immunosuppression. NGAL determinations will bne made in the first months after transplantation to correlate with clinical DGF.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have known Epstein-Barr virus (EBV) serostatus, and that status must be positive
* Adult patients ≥18 years of age, receiving a deceased donor kidney transplant at Columbia University Medical Center (CUMC)
* Patients with a PRA ≤ of 50
* Primary or re-transplant candidates (no more than 5th renal transplant)
* Deceased donor renal transplant recipients
* Candidates eligible for rATG induction
* Patients fully consented prior to transplantation
* Women of reproductive age who are willing to delay pregnancy for the duration of the study and use appropriate recommended contraception

Exclusion Criteria:

* Seronegative or unknown EBV serologic status (due to the risk of post-transplant lymphoproliferative disorder, PTLD), predominantly involving the central nervous system.
* Patients with tuberculosis who have not been treated for latent infection.
* Scheduled to undergo multi-organ transplantation
* Recipients of previous non-renal organ transplant
* Patient receiving 5th renal transplant at the time of screening.
* Patients with a PRA \> 50
* Recipient is pre-emptive status.
* Recipient with positive flow crossmatch.
* History or known HIV
* Known hypersensitivity or contra-indications to Belatacept, Tacrolimus, Mycophenolate mofetil (cellcept), or mycophenolic acid
* Use of an investigational drug in the past 30 days before day of surgery
* Enrolled in a clinical trial other than the current
* Lactating or pregnant women
* Donor specific antibodies (DSA) identified at the time of transplantation
* ABO incompatible renal transplant
The Study of Minocycline for Negative and Cognitive Symptoms in Schizophrenia

The purpose of this study is to determine whether minocycline are effective in the treatment of negative and cognitive symptoms in schizophrenia.

Immune-related disorders have been hypothesized as etiological factors in schizophrenia.Minocycline is a second-generation tetracycline that exerts anti-inflammatory and antimicrobial effects while having a distinct neuroprotective profile.This study was performed as a double-blind, placebocontrolled,randomized evaluation of Second generation antipsychotics(SGA) and minocycline versus SGA and placebo.

Eligibility Criteria:
Inclusion Criteria:

* male and female,were aged 18-40 years
* were currently diagnosed with DSM-IV schizophrenia
* were able to comprehend the cognition test
* patients or guardian signed informed consent,were able to comprehend the procedure and aims of the study,agreed to join the study
* patient's current antipsychotic medication regimen must be stable
* must be in a stable living arrangement

Exclusion Criteria:

* had ever been hypersensitivity to minocycline or tetracycline;
* had acute,unstable,significant,or untreated medical illness besides schizophrenia
* were pregnant or breast-feeding;
* had a DSM-IV diagnosis of substance abuse or dependency;
* had a tendency to suicide or Violence,self-harm;
* had taken immunosuppressive agents in the preceding 3 months before study entry;
* had influenza or fever in the preceding 2 weeks before study entry;
* had a DSM-IV diagnosis of emotional psychosis,Mental retardation,etc.
* has suicidal attempts or ideation or violent behavior within the last 12 months
* patient has mental retardation or severe organic brain syndromes
* treatment with Electroconvulsive Therapy (ECT) within 6 months prior to screening
Comprehensive Behavioral (ComB) Model of Treatment for Trichotillomania

This study will be the first randomized controlled trial of Comprehensive Behavior Modification (ComB) as a treatment of trichotillomania (TTM). ComB treatment (12 weekly sessions, following a manual developed in an earlier treatment development project) will be compared to Minimal Attention Control among adults (N = 42) with TTM.

Treatment based on the ComB model has been influential in the field of body-focused repetitive behaviors (BFRB's), but there is limited empirical research on its efficacy. Our first project (Falkenstein et al., 2016) developed a 12-session manual for ComB and a method for evaluating therapist adherence to the model that can be used reliably and provided encouraging (uncontrolled) data on the effects of ComB through 3-month follow-up.

The proposed project extends the earlier work in two main ways: (a) using random assignment to ComB vs. comparison condition to test whether ComB works better than the passage of time + demand characteristics of being in a TTM study alone; and (b) gathering initial evidence on how ComB works.

Treatment will be conducted at two sites -- Washington, DC (American University and the Behavior Therapy Center of Greater Washington) and Chicago (University of Chicago). Participants in the Minimal Attention Control condition will receive ComB therapy after the post-treatment \[week 12\] assessment is conducted. Uncontrolled follow-up data will be collected through 3 (MAC condition) or 6 (immediate ComB condition) months after the end of ComB treatment.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older

  * diagnosed with Trichotillomania
  * medication type and dosage \[if any\] stable for at least 3 months

Exclusion Criteria:

* active suicidality

  --probable bipolar disorder
* probable psychosis

  * other pressing clinical problem requiring immediate treatment
  * current psychotherapy and unable/unwilling to discontinue
Febrile Urinary Tract Infection Randomized Short Treatment Trial

The purpose of this study is to determine whether a 7-day duration of antibiotic treatment of febrile urinary tract infection (FUTI) is non inferior to 14-day standard duration of treatment in unselected population presenting at primary care or emergency department.

In the last decades hospitalization rates of patients with acute pyelonephritis (AP) or FUTI has decreased from almost 100% to 10-30%. The outpatient management of patients with FUTI has become popular as well as oral antimicrobial treatment regiments and shortening of treatment duration. However, as such approaches are only discovered in otherwise young health non-pregnant women, the best management of FUTI in the elderly, men and patients with co-morbidity remains elusive. Bases on personal perception of the attending physician antibiotic treatment, duration varies approximately between 7-14 days. Facing the aging of the general population, it is urgent to better define the optimal treatment for AP or FUTI in an unselected population and to identify those at risk for treatment failure or poor outcome to guide and optimize individual patient management and to prevent on the one hand unnecessary long treatment duration and hospital admission and on the other hand unsafe short duration or unsafe outpatient management.

In this study the efficacy and safety of a 7-day antimicrobial regimen compared to a 14-day antimicrobial regimen will be evaluated in an unselected population presenting with FUTI at primary care or emergency department. In addition a clinical and/or biomarker based scoring system of disease severity will be derived to predict those at risk for treatment failure or poor outcome.

Eligibility Criteria:
Inclusion Criteria:

* Competent patient aged 18 years or above
* One or more symptom(s) suggestive of urinary tract infection (dysuria, frequency or urgency\*; perineal or suprapubic pain; costo-vertebral tenderness or flank pain)
* Fever (ear or rectal temp of 38.2 oC or higher, or axillary temp of 38 oC or higher), or history of feeling feverish with shivering or rigors in the past 24 hours
* Positive urine nitrate test and/or leucocyturia as depicted by positive leukocyte esterase test or microscopy

Exclusion Criteria:

* Known allergy to fluoroquinolones
* Female patients who are pregnant or lactating
* Patients with known polycystic kidney disease
* Patients on permanent renal replacement therapy (hemodialysis or peritoneal dialysis)
* Patients with history of kidney transplantation
* Residence outside country of enrolment
* Inability to speak or read Dutch
* Isolated causal uropathogen resistant to ciprofloxacin
* Renal abscess
* Chronic bacterial prostatitis
* Suspicion or evidence of any metastatic infectious foci
Normothermia Protocol for Traumatic Brain Injury Patients

Comparison between a normothermia protocol and current protocol (acetaminophen plus blankets)

1. Normothermia Protocol is successful in achieving and maintaining normal temperature in moderate to severe Traumatic Brain Injury (TBI) patients.(using Arctic Sun for 96 hrs from admission to Neuro ICU)
2. Normothermia is translated into improved neurologic Outcome and survival compared to standard of care (Physician management)


Eligibility Criteria:
Inclusion Criteria:

* Severe TBI patients(GCS 3-9) admitted to ICU

Exclusion Criteria:

* Less than 18 years OLD.
* Bleeding disorders.
* Pregnancy/Breastfeeding.
* Hepatic Encephalopathy.
* Spinal cord injury (know or new)
* Fever \>100 F prior to randomization.
* Blood Alcohol level \>80
* Participation in other Research trial.
* Inability/unwilling to obtain Informed consent.
* Terminal illness(not expected to survive 3-6 months)
* Not expected to survive 24 hrs.
Prone Positioning for Patients on General Medical Wards With COVID19

COVID-PRONE is a multicenter, pragmatic, unblinded, 2-arm, parallel, randomized controlled trial seeking to compare the pre-emptive prone positioning (i.e. encouraging patients to adopt a prone position before they require mechanical ventilation) to the control arm of standard care alone. Randomization will be stratified by site.

COVID-PRONE is a multicenter, pragmatic, unblinded, 2-arm, parallel, randomized controlled trial. The intervention is not a medication or a medical device. Instead, the intervention is instructing patients to lie on their stomach while they are in bed.

Patients will be randomized to receive either standard-of-care or pre-emptive prone positioning while in bed plus standard of care. Randomization will be stratified by site. Patients randomized to prone positioning will be instructed to i) lie on their stomach supported by their arms and a pillow at the level of their shoulders and another pillow at the level of the pelvis, ii) immediately thereafter their oxygen saturation will be checked, iii) after a two hour period they can reposition to supine (but should be educated on the use of prone position and encouraged to adopt prone position as often as tolerated while in bed); the 2-hour period will be encouraged four times each day in addition to during sleep overnight.

Since there are limited data on the potential risks and benefits of prone positioning, a feasibility analysis will be performed after 30 patients are randomized to identify the rate of serious adverse events in the prone group (e.g., rate of pneumonia, death, intubation) and to understand the change in oxygenation as a result of prone positioning.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years of age
2. COVID-19 infection is suspected by the treating clinician or confirmed by diagnostic test
3. Able to lie on their stomach with verbal instruction
4. Requiring supplemental oxygen less than or equal to 50% FiO2
5. Capable to make treatment related decisions
6. Hospitalized in the last 48 hours with suspected or confirmed COVID-19 infection or diagnosed for nosocomial infection in the last 48 hours during their hospital stay

Exclusion Criteria:

1. Inability to follow commands (e.g., delirium, dementia)
2. indication for mechanical ventilation (e.g., reduced level of consciousness, rapid clinical deterioration)
3. contraindication to prone positioning (spinal cord injury, unstable c-spine, pelvic fracture, unstable airway, open chest or abdomen, anterior chest tube, recent abdominal surgery in past 14 days)
4. patients on home CPAP (continue positive airway pressure)
5. transfer from ICU in past 72 hours
6. need for telemetry at the time of randomization
7. pregnant (i.e., more than 20 weeks)
8. body mass index above 40 kg/m2 (based on clinician's assessment)
9. Recently completed or plan for intrathoracic or intra-abdominal surgical procedure
10. severe hemoptysis
11. pace-maker inserted in past 48 hours