cyrilzakka/clinical-trials huggingface dataset:
Cognitive-Behavioral Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in College Students - Study 1

College students with ADHD have significant difficulty effectively managing their time, organizing, planning, and completing their academic work. As a result, they typically have lower grade-point averages, more course failures and withdrawals, are more likely to be placed on academic probation and are less likely to graduate from college than students without ADHD. The purpose of this project is to refine and test a psychological intervention on campus to help students with ADHD develop these self-management skills so that they can be more successful in college and avoid these negative outcomes.

Participants will be assessed pre- and post-intervention during interviews with the clinician-investigators and on several self-report questionnaires designed to assess their self-management of time, organization, and planning. Feedback of the results will be discussed with them, including any recommendations for further treatment.

Eligibility Criteria:
Inclusion Criteria:

* Student at The City College of New York
* Diagnosis of ADHD, Inattentive or Combined Subtype
* In good physical health

Exclusion Criteria:

* Actively abusing drugs or alcohol within the past 6 months
* Actively suicidal
* Diagnosis of borderline personality disorder
* Diagnosis of bipolar disorder
* Diagnosis of a psychotic disorder
* Neurological disorder (such as traumatic brain injury, brain tumor, Parkinson's)
* History of childhood abuse or trauma or psychiatric condition that prevents clear
* confirmation of the presence of ADHD in childhood
* Any other acute psychiatric condition (e.g. acute panic disorder, severe depression) with treatment needs that take precedence over ADHD.
Novel Probiotic Treatment for Prevention of Recurrent UTIs in Children

Background:

Urinary tract infections (UTIs) are a common and costly cause of doctor visits for children. Frequent UTIs trigger kidney damage that leads to serious diseases like high blood pressure, pregnancy complications, and kidney failure. Treating UTIs with preventative antibiotics has not shown improvement of the risk of these diseases, and contributes to the growing public health issue of antibiotic resistant bacteria. Bacteria that cause UTIs originate from the bowel. In an effort to reduce the number of UTIs, investigators want to exchange the bacteria living in our bowels for a more harmless variety.

Hypothesis and specific aims:

Investigators hypothesize a probiotic comprised of a probiotic bacteria will change the bowel bacteria, thereby reducing the numbers of infection-causing bacteria, thus reducing frequency of UTIs in healthy patients with recurrent UTIs and those patients with urinary tract problems that require use of catheters to empty their bladders.

Aim 1: Investigators plan to challenge infection-causing bacteria like Pseudomonas species, Enterococcus species, and Klebsiella species to live in the same environment with the probiotic bacteria to see how the numbers of each bacteria change.

Aim 2: Investigators will culture bacteria that live on urinary catheters and then challenge them to live in the same environment as the probiotic bacteria.

Potential Impact:

This novel treatment prevents UTIs by exchanging a patient's bowel bacteria for a harmless bacteria and reduces the use of antibiotics overall in the community.


Eligibility Criteria:
Inclusion Criteria:

* Patients with urinary catheters placed that will be getting them removed

Exclusion Criteria:

* Patient's currently getting treated for UTI
History of Hepatitis C in Volunteer Blood Donors

Hepatitis C is a disease of the liver caused by the Hepatitis C Virus (HCV). Patients with hepatitis C may feel well and show no signs or symptoms of being ill. However, researchers would like to study the long-term effects of this disease.

Volunteer blood donors diagnosed with chronic hepatitis C viral (HCV) and various levels of liver enzyme activity will be offered a complete medical evaluation and liver biopsy. The tests will enable researchers to provide the patients with an idea of how severe their liver disease is. The virus and patient will be studied in order to understand why patients with hepatitis C develop different levels of liver damage.

A selected sample of volunteer blood donors with chronic hepatitis C viral (HCV) infection and various levels of serum aminotransferase activity will be offered a complete medical evaluation and liver biopsy to determine the severity of their liver disease. Various virological and host factors will be studied in an attempt to determine why patients with HCV infection develop differing degrees of liver disease.

Eligibility Criteria:
Patients with chronic hepatitis C.

Age 18 to 70 years, male or female.

HCV infection indicated by the presence of anti-HCV (by ELISA and recombinant immunoblot assay \[RIBA\]).

Written informed consent.

Women must not be pregnant.

Patients must not have significant systemic illnesses other than liver disease, including congestive heart failure, renal failure, uncontrolled diabetes mellitus.

Patients must not have antiviral or immunosuppressive therapy within the last 6 months.

Patients must not have HIV infection.

Patients must not have contraindications to liver biopsy (mainly clotting abnormality (coumadin therapy, platelet count less than 50,000/cubic millimeter, prothrombin time more than 4 seconds beyond control)).
Analysis of Effectiveness and Safety of Teclistamab in Relapsed and Refractory Multiple Myeloma Patients

200 adult patients with multiple myeloma receiving teclistamb will be included. Effectiveness, safety, and condition of use of teclistamab in early access program (post-MA) will be assessed. Primary objective is the evaluation of overall response rate (ORR) of teclistamab according to IMWG criteria.

This is a multicenter, prospective, observational study.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (≥18 years) with multiple myeloma who will receive at least one dose of teclistamab (first dose of the step-up dose)

Exclusion Criteria:

* Patients alive at the start of the study who did not receive study information or who objected to the collection of data
* Patients who received teclistamab as part of an interventional clinical trial
* Patients who are initiating teclistamab as part of a current interventional clinical trial
Effects of Pravastatin on Cholesterol, Inflammation and Cognition in Schizophrenia

This study involves people with schizophrenia or schizoaffective disorder, who are currently taking antipsychotic medications. Some antipsychotic medications may cause an increase in cholesterol levels, which may lead to inflammation in the body. Inflammation poses a risk in developing heart disease, diabetes and problems with brain function. The purpose of this study is to see if pravastatin can:

* Lower cholesterol
* Decrease inflammation
* Improve cognition in patients with schizophrenia

This study is a 12-week randomized, double-blind, placebo-controlled pilot study of pravastatin 40mg a day, administered for 12 consecutive weeks to subjects with schizophrenia to examine pravastatin's effects on lowering cholesterol levels and inflammatory markers, and improving cognition. The study will be conducted at the Freedom Trail Clinic and will use the Massachusetts General Hospital Clinical Research Center. The innovative approach of using pravastatin to not only decrease cholesterol levels, but to decrease inflammation and improve cognition in patients with schizophrenia is promising and may lead to a different approach to treatment in this population.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 18-68 years
* Diagnosis of schizophrenia, any subtype, schizoaffective disorder, any subtype or schizophreniform disorder
* Well established compliance with outpatient medications including their antipsychotic medication

Exclusion Criteria:

* Inability to provide informed consent
* Current substance and alcohol abuse
* Significant medical illness, including congestive heart failure, severe cardiovascular disease, renal disease (serum creatinine \> 1.5), severe hepatic impairment or active liver disease, anemia (hemoglobin \<11.0 gm/dL), history of severe head injury, and not treated muscle disease.
* Psychiatrically unstable
* Women of child bearing potential who are pregnant, breastfeeding, or who are unwilling or unable to use an effective form of birth control during the entire study
* Subjects treated with anti-inflammatory drugs (including daily aspirin and ibuprofen), thiazide diuretics; agents that induce weight loss, and St. John's Wort will be excluded from the study
* Current history of untreated thyroid disease
* Current treatment with insulin
* Subjects being treated with drugs such as: colchicine, azole antifungals (fluconazole, ketoconazole, itraconazole); macrolide antibiotics (clarithromycin, erythromycin); HIV protease inhibitors (ritonavir, indinavir, saquinavir, nelfinavir) that inhibit the CYP 450 3A liver enzyme
* Known hypersensitivity to pravastatin or any of its components
Effects of Dexmedetomidine on Postoperative Renal Function Recovery After Kidney Transplantation in Adult Patients

Postoperative renal function recovery is very important to value the operation quality after kidney transplantation. Dexmedetomidine is a selective alpha-2 agonist,enhances urine flow rate and perioperative renal function. Some animal experiments have revealed its beneficial effects against ischemia-reperfusion injury (IRI), our goal is therefore to investigate the effectiveness of a recipient treatment with Dexmedetomidine during operation at reducing Cystatin C level and enhancing renal function after kidney transplantation.

Participants will be randomly assigned, in a 1:1 ratio, to receive Dexmedetomidine or control (0.9 %Sodium Chloride Solution,0.9%NaCl). The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center.Dexmedetomidine and 0.9 %NaCl solution will be treated from 10 minutes before anesthesia induction, ending in the last 10 minutes before the operation to complete. Cystatin C level and urine volume (but are not limited to these data) at 1,7,14 days after the transplantation will be recorded. The participation of each patient is scheduled for 14 days.Investigators will research both living and cadaveric kidney transplants.

Eligibility Criteria:
Inclusion Criteria:

Patients underwent renal transplant in the First Affiliated Hospital of Xi'an Jiaotong University.

Exclusion Criteria:

severe comorbidity history: severe cardiac dysfunction, central nervous system disease, endocrine, and history of mental disorders; alcoholic and long-term use of sedatives and opioids history; drug allergy history.
Pragmatic Randomized Controlled Trial of Non-pharmacological Treatment for Lumbar Disc Herniation : A Pilot Study

This is a 2-arm parallel pragmatic randomized controlled trial that will compare non-pharmacological treatment with pharmacological therapy for lumbar disc herniation.

Participants who voluntarily signed informed consent form and eligible for the study were randomly assigned in a 1:1 ratio (15:15) for non-pharmacological treatment and pharmacological treatment group. Participants of each group will receive twice a week for total 8 weeks of intervention. This is a pragmatic randomized controlled trial, so physicians will have medical decision making according to each participant's conditions and choose the specific intervention and dosage of pharmacological and non-pharmacological treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Numeric rating scale (NRS) score of radiating pain 5 or more for recent 3 serial days.
2. Onset time of radiating pain occurred within 12 weeks.
3. Radiologically diagnosed with lumbar disc herniation in lumbar spine magnetic resonance imaging (L-spine MRI)
4. 19-70 years old
5. participants who agreed and signed informed consent form

Exclusion Criteria:

1. Spine metastasis of cancer, acute fracture of spine, or spine dislocation
2. Progressive neurologic deficits or severe neurologic deficits
3. Soft tissue diseases that can induce low back pain(ie. cancer, fibromyalgia, rheumatoid arthritis, gout,etc)
4. Presence of chronic underlying disease which can interfere the efficacy or interpretation (ie. stroke, myocardial infarct, kidney disease, dementia, diabetic neuropathy, epilepsy, etc)
5. Concurrent use of steroids, immunosuppressants, orpsychotropic medications or any other medication that can interrupt the study result
6. Hemorrhagic disease, severe diabetes or taking anticoagulant drug
7. Participants who took NSAIDs or pharmacopuncture within 1 week
8. Pregnant or lactating women
9. Participants who had undergone lumbar surgery within 3 months
10. Participants who had participated in other clinical trial within 1 month, or have plan for participation in other trial during follow up period of this trial
11. Participants who can not write informed consent
12. Participants who is difficult to participate in the trial according to investigator's decision
Risperidone Maintenance Treatment in Schizophrenia

This study set out to determine the duration of maintenance treatment with therapeutic risperidone dose in schizophrenia. In a multi-center, open label, randomized, controlled study design, patients with schizophrenia who were clinically stabilized following an acute episode were randomly assigned to a 'maintenance group' (optimal therapeutic doses continued for at least 1 year), a 4-week group (optimal therapeutic doses continued for 4 weeks followed by a 50% dose reduction that was maintained for at least 11 months) or a 26-week group (optimal therapeutic doses continued for 26 weeks followed by a 50% dose reduction for at least another 6 months).

Prevention of relapse is the crucial task in the maintenance treatment of schizophrenia. This study set out to determine the duration of maintenance treatment with therapeutic risperidone dose in schizophrenia. In a multi-center, open label, randomized, controlled study design, patients with schizophrenia who were clinically stabilized following an acute episode were randomly assigned to a 'maintenance group' (optimal therapeutic doses continued for at least 1 year), a 4-week group (optimal therapeutic doses continued for 4 weeks followed by a 50% dose reduction that was maintained for at least 11 months) or a 26-week group (optimal therapeutic doses continued for 26 weeks followed by a 50% dose reduction for at least another 6 months).

Eligibility Criteria:
Inclusion Criteria:

1. in- or outpatient of either sex diagnosed with DSM-IV schizophrenia
2. having been clinically stable following an acute episode for at least 4 but less than 8 weeks, with 'clinical stability' defined as a sum score of the Brief Psychiatric Rating Scale (BPRS) of less than 36 points
3. aged between 18 and 65 years
4. receiving risperidone monotherapy titrated to optimal level in the acute phase of treatment for the psychotic episode
5. local resident, living with at least one family member after discharge
6. having satisfactory treatment adherence defined by a pill count that yielded more than 80% adherence to risperidone prescription over the past 4 weeks
7. understanding the aims of the study and having signed the consent form

Exclusion Criteria:

1. taking antidepressants, mood stabilizers, and Chinese herbal remedies concomitantly with risperidone, or having received electroconvulsive therapy (ECT), or participating in any other drug trials or interventional studies over the 4 weeks before study entry
2. having a history or ongoing experience of major chronic medical or neurological condition(s) requiring treatment that would be likely to affect psychic functions
3. past or current drug/alcohol abuse other than nicotine
4. being pregnant or having plans to become pregnant, lactating, or not practicing an effective method of birth control
The Use of Low Dose Prophylactic Naloxone Infusion to Prevent Respiratory Depression With Intrathecal Morphine.

This is an investigator led, randomised, double blind, placebo controlled, double arm comparator study.

Delayed respiratory depression is a well-documented side effect associated with the use of intrathecal morphine. This respiratory depression has implications for patient safety and necessitates either the observation of the patient in a high dependency setting for at least 24 hours or the use of an alternative analgesic technique. Other associated side effects include pruritus, nausea and vomiting and sedation. Naloxone is the most effective treatment for these side effects. However, it is usually given as a reactive treatment when the side effect presents.

The hypothesis is that patients who are commenced on a naloxone infusion at low dose early after injection of intrathecal morphine will have a clinically significant reduction in incidence of these side effects. The primary endpoint is a reduction in respiratory depression.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be aged 18 years or above at baseline
* Diagnosed with any hepatobiliary condition requiring an elective major surgical resection under general anaesthetic.
* Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol

Exclusion Criteria:

* Allergy/sensitivity to naloxone
* Female subjects who are pregnant or breast-feeding.
* Subjects who have received any other investigational agent within 2 months
* Subjects taking anticonvulsant medications for epilepsy
* Subjects who have a cardiac arrhythmia with an uncontrolled rate
* Subjects who have a history of chronic opioid use / chronic pain
* Any contraindication to intrathecal injection eg coagulopathy
* Documented history of obstructive sleep apnoea
* Treating clinician feels not in the patients best interests to be randomised
Examining the Role of the Orexin System in Sleep and Stress in Persons With Opioid Use Disorder

This study is designed to elucidate the role of the orexin neurotransmitter system in sleep disturbance and circadian rhythms of stress that might in turn influence relapse behaviors in persons on medication-assisted treatments (MAT) who are in early recovery from opioid use disorder (OUD). Briefly, the study will enroll recently abstinent OUD patients (N=200) maintained on either extended-release naltrexone (XR-NTX), buprenorphine, or methadone. Within each MAT group, participants will be randomized to either suvorexant or placebo. The study is expected to have a 20% treatment attrition rate which will result in N=160 completers in the entire study. Patients will be recruited from and treated at Ashley Addiction Treatment, Addiction Treatment Services at Johns Hopkins Bayview Medical Center, Man Alive, or community providers.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 21-65, inclusive.
* Past 30-day sleep disturbance as evidenced by a Pittsburgh Sleep Quality Index Total Score \>5.
* Enrolled in either outpatient methadone-maintenance, buprenorphine-maintenance, or XR-NTX treatment for OUD.
* Willingness to be maintained on a protocolized dose starting between 60-130mg methadone or 380mg XR-NTX for the duration of the study.
* At least two weeks of continuous abstinence from illicit opioids as evidenced by self-report and urine drug screens collected as part of routine care.
* Willing to comply with the study protocol, which will include weekly study visits, daily actigraphy and ecological momentary assessments.
* Use of birth control throughout study.
* Have no clinically significant chronic medical disorders or conditions that are judged by the investigators to prevent participation.

Exclusion Criteria:

* Serious mental illnesses that are unstable and could affect study participation (thought disorders, hallucinations, delusions, thoughts of harm to self/others).
* Current moderate to severe substance use disorder other than OUD.
* Current illicit stimulant use, including cocaine and methamphetamine.
* Pregnant or breast feeding.
* Have a known allergy to the study medications.
* Past 30-day prescribed use of suvorexant.
* Current use of a benzodiazepine or other schedule IV medication for insomnia.
* Use of Cytochrome P450 3A inhibitors.
* Current narcolepsy, sleep paralysis, or restless leg syndrome as assessed by medical history
* Apnea-hypopnea index \> 30.
* Use of glucocorticoid medications and any medication that would alter the hypothalamic-pituitary-adrenal axis.
* Past 30-day suicidal behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).
* Have circumstances that would interfere with study participation (e.g., impending jail; severe clinical issues).
Resistance Training in Patients With Chronic Obstructive Lung Disease (COPD): Whole Body Vibration Versus Conventional Resistance Training

Pulmonary rehabilitation has been emerged as a recommended standard of care for patients with chronic lung disease based on a growing body of scientific evidence. A set of evidence-based guidelines were published in American College of Chest Physicians (ACCP) and the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR). Since then, the published literature in pulmonary rehabilitation has increased substantially, and other societies have published important statements about pulmonary rehabilitation (eg, the American Thoracic Society and the European Respiratory Society).

In patients with COPD, there is a strong scientific basis for implementing conventional resistance training (CRT) in addition to endurance training. Endurance training, such as walking, is a key component of pulmonary rehabilitation and improves in exercise tolerance and muscular endurance. However, this type of training may not reverse muscle weakness or atrophy. For that reason, strength training seems to be the optimum training modality to increase muscle mass and strength.

Recently, Whole-Body-Vibration (WBV) training has been promoted as an alternative for resistance training on multigym equipment. In WBV training, the subject stands on a platform that generates vertical sinusoidal vibration, during which static and dynamic exercises can be performed.

The present study is conducted to provide an answer on the following question: will a resistance training program, such as the whole body vibration, be even effective than a conventional resistance training program in patients with COPD.


Eligibility Criteria:
Inclusion Criteria:

* Patients with COPD candidate for pulmonary rehabilitation
* Men and female between 40 and 80 years of age
* Written informed consent to participate

Exclusion Criteria:

* Severe cardiac, neurological and orthopedic co-morbidity interfering with exercise training.
* Pacemaker
* Hip, knee of shoulder prosthesis or recently introduced spirals, metal pens, bolts or plates
* Uncontrolled diabetes, epilepsy or migraine
* Osteoporotic or metastatic fractures, acute hernia, discopathy, spondylitis