cyrilzakka/clinical-trials huggingface dataset:
rTMS for Adolescents and Young Adults

rTMS is a promising, though largely untested, option for treating adolescent and young adult depression. This study hypothesizes that rTMS will safely and significantly alleviate depression and decrease suicidal ideation in adolescents and young adults based on previous studies.

After signing consent and undergoing a thorough screening, participants will be administered rTMS 5 days per week for 4 consecutive weeks (a total of 20 sessions) as an add-on to their current antidepressant regime. Adolescents must be accompanied by a parent or legal guardian. We will monitor for depression, anxiety and suicidal ideation over the 4 weeks as well as 1 week following the last rTMS administration using rating scales. These scales will be given once a week, on Fridays, and will require roughly 40 minutes to complete. TMS sessions will last approximately 25 minutes each.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with MDD by a child and adolescent psychiatrist based on the DSM-IV, have a CDRS score of at least 60 or an HDRS score of at least 22 and have been suffering with depression during the current episode for at least 3 months
* Currently seeing a Johns Hopkins psychiatrist
* Excellent documentation of treatment resistance:

  * to at least 2 different antidepressant treatments, defined as resistance to a minimum of two antidepressant drug trials of adequate dose and duration in the current episode or previous episodes, adequacy being defined as a minimum level of three on the ATHF per antidepressant drug trial (those who have not completed antidepressant trials of adequate dose and duration due to intolerance to therapy may be included if they have demonstrated intolerance to three or more antidepressant medications in the current or a previous episode)
  * to at least one course of psychotherapy which did not result in significant alleviation of depressive symptoms
* No changes in medication dose or psychotherapy frequency over the previous 1 month
* Negative answers on the safety screening questionnaire for rTMS

Exclusion Criteria:

* History of substance abuse or dependence within the past six months (excluding nicotine and caffeine) or marked conduct disordered or oppositional behavior
* Any current unstable medical or surgical illness
* Bipolar Disorder
* Psychotic symptoms
* History of head injury or seizure or history of seizure in a first degree relative.
* History of any metal in the head (outside the mouth).
* Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps
* History of frequent or severe headaches or migraines
* History of hearing loss or known history of cochlear implants.
* Pregnancy or not using a reliable method of birth control.
* Participation in another clinical trial within 30 days of this study
* Inability to locate and quantify a motor threshold (MT) as defined by the rTMS protocol
* Current use of drugs known to lower seizure threshold, such as stimulants, wellbutrin, bupropion, and certain tricyclics (e.g. clomipramine and maprotiline)
* Left-handed
Intraocular Pressure in Ocular Hypertensives With Scleral Lens Wear

The purpose of this study is to determine if short-term wear of a spherical rigid contact lens, called a scleral lens, will raise intraocular pressure in ocular hypertensive patients.

This is a randomized, self-controlled study designed to compare effectiveness of a scleral lens on intraocular pressure. In this study, all participants have one eye randomly selected to wear the scleral lenses during study measurements and the other eye serves as the control, non-lens wearing eye.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ocular hypertension (IOP \>22 in each eye during at least two visits over the previous 3 years)
* May have had cataract extraction and intraocular lens (IOL)
* Not on topical medication for glaucoma
* No History of ALT/SLT
* Any Age, 18 years or older
* History of contact lens wear (except scleral lenses), as long as they are willing to not wear their lenses the day of the study

Exclusion Criteria:

* On topical medication for glaucoma
* Eye disease
* Inability to wear scleral lenses
* Any intraocular surgery other than uncomplicated cataract extraction.
* Known allergy to proparacaine eye drops
Effects of Aerobic Training Program On Liver Functions

The liver plays a central role in energy exchange, protein synthesis as well as the elimination of waste products from the body. The optimal functioning of the liver is essential for athletic performance. It becomes necessary to maintain the enzymes of the liver at an optimal level so that liver cells can be protected from inflammation or damage. This paper investigated the effects of a twelve-week aerobic exercise program on the liver function of adult athletes. A total of thirty (30) healthy male athletes aged 21 to 24 were recruited for this study and kept in two equal groups. The control group was kept under rigorous supervision and did not participate in any special activities. The experiment group was well-versed in their assigned training program and solely performed the experimental procedure for twelve (12) weeks. Evaluation of all patients in both experimental and control groups was carried out before and after the treatment program by measuring the levels of (Alkaline phosphate, AST/SGOT, ALT/SGPT, Bilirubin Total/indirect/direct, Albumin, Globulin, and Total protein) respectively using standard methods by collecting blood samples, 5 mls each of baseline into lithium heparin containers for estimation of above biochemical parameters at the pathology laboratory accredited by National Accreditation Board for Testing and Calibration Laboratories accredited (NABL, India).


Eligibility Criteria:
Inclusion Criteria:

* Male
* Age: 21-24 years
* Healthy
* Athletes

Exclusion Criteria:

* history of severe illness,
* surgery, or damage to liver,
* fatty liver disease,
* cirrhosis,
* blood infections,
* neuromuscular illnesses,
* or the presence of any disorders such as fever, high blood pressure, high blood sugar
Ventriculostomy in Subarachnoid Hemorrhage (SAH): Intracranial Pressure (ICP) Open or Not?

The purpose of this study is to explore two currently accepted methods of intracranial pressure (ICP) management through cerebral spinal fluid (CRF) drainage for patients diagnosed with subarachnoid hemorrhage (SAH). This is a randomized observational study of two physician-prescribed approaches to managing ICP monitoring and CSF drainage for SAH patients. The study will enroll only those patients who have ICP monitoring. Because this is an observational study, there are no physical risks to the patient, the only risk is loss of confidentiality.

Patients diagnosed with subarachnoid hemorrhage (SAH) who require intracranial pressure (ICP) management through cerebral spinal fluid (CRF) drainage will be eligible for this study.

Subjects will be randomized to receive one of two currently accepted methods of ICP management. The first is ICP monitoring with intermittent CSF drainage and the second is through continuous CSF drainage at set pressure thresholds.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to Duke University NCCU
* Adult (18 years of age or older)
* Primary diagnosis is Subarachnoid Hemorrhage
* Intraventricular catheter in situ

Exclusion Criteria:

* Glasgow Coma Score = 3
* Hunt and Hess Score = 5
* Prisoners
* Ventriculostomy \> 72 hours
Long-Term Follow-up of Children for a 2-Year Period to Confirm the Safety and Immunogenicity of GSK 257049 Vaccine

The RTS,S/AS02A vaccine (or GSK 257049 vaccine), GSK Biologicals' candidate Plasmodium falciparum (P. falciparum) malaria vaccine is being developed for the routine immunization of infants and children living in malaria endemic areas. The vaccine would offer protection against malaria disease due to the parasite P. falciparum. The vaccine would also provide protection against infection with hepatitis B virus (HBV).

This phase IIb trial is being carried out following the demonstration of efficacy of the candidate malaria vaccine in children in Mozambique: there, the vaccine demonstrated approximately 30% efficacy against clinical episodes of malaria and approximately 58% efficacy against severe malaria disease.

In this study, the children from Mozambique (NCT= NCT00197041) are followed-up to assess the safety, immunogenicity and efficacy of the candidate malaria vaccine for a two year period commencing 21 months after Dose 1.

This protocol posting deals with objectives \& outcome measures of the extension phase at year 2. During this extension study, no new subjects will be recruited and no vaccine will be administered.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Eligibility Criteria:
Inclusion criteria:

* Completion of Visit 7, Month 21 of 104297 (NCT= NCT00197041).
* Written informed consent obtained from the parent(s) or guardian(s) of the subject

Exclusion criteria:

* Planned use of any investigational or non-registered drug or vaccine during the study period.
* Simultaneous participation in any other clinical trial
Fetal Lung Maturation in Twin Gestations

Objectives:

To evaluate discordance in lung maturity in diamniotic twins based on birth order, sex and body weight. If we find discordance in fetal lung maturity in twin gestations this will change current practice of sampling only one amniotic sac for evaluation of fetal lung maturity.

Objectives:

To evaluate discordance in lung maturity in diamniotic twins based on birth order, sex and body weight. If we find discordance in fetal lung maturity in twin gestations this will change current practice of sampling only one amniotic sac for evaluation of fetal lung maturity.

Hypotheses:

Lung maturation within twin pairs is weakly correlated based on presentation and estimated fetal weight.

Research Methods:

This study will be prospective cohort study of women with twin diamniotic intrauterine gestations who will be delivered at a Good Samaritan or Bethesda North Hospital. Patients will be counseled and informed consent for participation in the study will be obtained prior to enrollment in study.

At the time of Cesarean delivery or in the event of amniocenteses for FLM, a sample of amniotic fluid will be drawn from the amniotic sac of Twin A and Twin B. Each amniotic sac will be aspirated by the obstetrician and sent to the laboratory for determination of fetal lung maturity index and lamellar body count. Fetal lung maturity index and lamellar body count will be correlated to see if there is an association between Twin A and Twin B.

Fetal Lung Maturity index and lamellar body count will be calculated and compared based on fetal weight, sex, zigosity, and birth order. Demographic information, maternal obstetrical and medical history, newborn/fetal data, indications for cesarean section and twin A and B outcomes will be obtained through OB Traceview or patient chart.

Study population:

Participants will include pregnant patients, greater than 24 completed weeks with diamniotic twin gestations, at Good Samaritan and Bethesda North Hospitals. Patients will be scheduled for a cesarean section by their primary MD prior to being approached for inclusion into the study.

Eligibility Criteria:
Inclusion Criteria:

Diamniotic twin gestations

* Twenty-four completed weeks gestation with dating calculated by their sure last menstrual period or utilizing a first trimester crown rump length ultrasound.
* English Speaking
* Scheduled cesarean section by patient's primary MD

Exclusion Criteria:

* Monoamniotic twins
* Presence of gross blood in amniotic sample
* Presence of meconium amniotic fluid
* Known/diagnosed fetal or newborn anomaly
* Twin to Twin Transfusion Syndrome (TTTS)
* Vaginal delivery
3D Bioprinted Models for Predicting Chemotherapy Response in Colorectal Cancer With/Without Liver Metastases

The therapeutic regimens of adjuvant and neoadjuvant chemotherapy for colorectal cancer (CRC) remain largely relied on clinical experience, and thus preclinical models are needed to guide individualized medicine. The investigators are going to establish 3D bioprinted CRC models and organoids from surgically resected tumor tissues of CRC patients with or without liver metastases. In vitro 3D models and organoids will be treated with the same chemotherapy drugs with the corresponding patients from whom the models are derived. The sensitivity of chemotherapy drugs will be tested in these two types of in vitro models, and the actual response to chemotherapy in patients will be evaluated. The predictive ability of 3D models for chemotherapy sensitivity in CRC patients will be compared with that of the organoids. This observational study will validate the potential value of 3D bioprinted tumor models in predicting the response to chemotherapy in CRC.


Eligibility Criteria:
Inclusion Criteria:

* More than 18 years old
* Diagnosed as colorectal cancer with or without liver metastases before
* Pathologically proven colorectal cancer after surgery

Exclusion Criteria:

* Medical history with other malignancies or serious diseases
* Disable to sign the informed consent independently
Exercise Training in Patients With Non-cystic Fibrosis (CF) Bronchiectasis

The aim of this project is to examine the short and long term effects of an 8 week, twice weekly, outpatient exercise training program for people with bronchiectasis. Participants will be randomly allocated to undergo a supervised exercise training program at The Alfred, Austin Hospital or Sir Charles Gairdner Hospital.

The hypotheses of this study are:

1. Patients with bronchiectasis who complete an exercise program will have a higher exercise capacity and better quality of life and these improvements will be sustained for up to 12 months after completion
2. Exercise training will significantly reduce the incidence of pulmonary exacerbations, use of antibiotics and rate of hospitalisation

Bronchiectasis not related to cystic fibrosis (non-CF bronchiectasis) is a chronic respiratory condition characterised by permanent dilatation of the airways arising from bronchial inflammation and infection. Predominant symptoms include daily productive cough, dyspnoea and generalised fatigue. This profile is associated with diminished health-related quality of life (HRQOL) and reduced exercise tolerance.

Available medical treatments for bronchiectasis include antibiotic and inhalation therapy. To date, there is no evidence that these treatments can reduce the exacerbation rate or modify the rate of disease progression. While international guidelines for pulmonary rehabilitation recommend the inclusion of patients with bronchiectasis, there is a deficiency in evidence supporting exercise training in this population. It is proposed that a standard exercise training program conducted according to Australian guidelines for pulmonary rehabilitation will improve both exercise capacity, quality of life and reduce the number of acute infections in both the short and long term in people with bronchiectasis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bronchiectasis (HRCT)
* Stable medical status for last 4 weeks
* History of 2 exacerbations in the last 2 years
* Dysnpoea on exertion (Modified Medical Research Council score \>1)

Exclusion Criteria:

* Concurrent diagnosis of COPD (physician diagnosis and history of 10 pack year smoking)
* Concurrent diagnosis of asthma (history of atopic disease and evidence of bronchodilator reversibility of 12% or 200ml in FEV1 or FVC)
* Concurrent diagnosis of Interstitial lung disease
* Concurrent diagnosis of Cystic Fibrosis
* Medical condition which could place patient at risk during exercise training (angina, neurological or orthopaedic condition)
* Prior completion of pulmonary rehabilitation within the last 12 months
Optimization of the Care Pathway for Patients With Chronic Pain: Assessing the Value of Integrating Sleep Specialists

DOLOREPIT is an interventional, RIPH 2, multicenter, randomized, controlled, open-label study comparing two care pathways for the management of patients with chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* First consultation at the pain management center
* Patient with chronic pain as defined by the "Haute Autorité de Santé". The pain must have several of the following characteristics:

  * Persistence or recurrence
  * Duration beyond what is usual for the presumed initial cause, especially if the pain has been evolving for more than 3 months;
  * Inadequate response to treatment;
  * Important and progressive deterioration of the patient's functional and interpersonal abilities in activities of daily living at home, school, or work due to the pain.
* Patients with chronic primary pain (according to the typology defined by the International Classification of Diseases-11) and classified into one of the 4 following categories:

  * Chronic generalized pain
  * Complex regional pain syndrome
  * Chronic primary headache or orofacial pain
  * Chronic primary musculoskeletal pain
* Pittsburgh Sleep Quality Index (PSQI) must be completed by the patient and the score must be available (for randomization purposes)
* Have access to an internet connection as a self-administered questionnaire is to complete online, and at least have access to the online platform for CBT treatment if insomnia is detected
* Affiliation to a French social security system
* Free informed consent

Exclusion Criteria:

* Patients undergoing cancer treatment or who have completed treatment within the last 2 years
* Patient with a chronic inflammatory disease (e.g. rheumatoid arthritis, ankylosing spondylitis, chronic inflammatory bowel disease, Horton's disease, Wegener's disease, myositis, Still's disease, lupus erythematosus, etc.)
* Immunocompromised patient
* Patient with severe psychiatric pathology that does not allow study follow-up (at the discretion of the investigator)
* Patient already treated for a sleep disorder by a sleep specialist (the only prescription of hypnotics is not considered as a criterion of non-inclusion)
* Patient follow-up difficult (for geographic motives or other reasons)
* Patient under judicial protection of incapable adults or guardianship
* Refusal to participate in the research
Exercise and Activity Guidance in Older Adults With Diabetes

The purpose of the project is to better understand how exercise and education will help mobility and health in older adults with diabetes. The investigators are trying to learn what type of exercises and classes are needed to help older adults stay active. This knowledge will eventually prove useful in helping patients and doctors understand what is needed to keep older adults with Type 2 diabetes as healthy as possible.

1. Information and health screening: Interested persons are screened for eligibility and undergo a directed medical history and examination, echocardiogram (if not done within one year), limited ABI test, and maximal treadmill test with oxygen kinetics.
2. Measure fitness level at the beginning of the exercise training, at 10 and 20 weeks: DEXA scan, body fat analysis, strength and balance measurements, and blood tests.
3. Train for 10 weeks in a supervised small group format. Classes meet three times a week for an hour. Participants are randomly assigned to:

1) Flexibility and toning exercises + health education, or 2) Functional circuit training + home activities + tailored physical activity guidance.

4. Follow-up phone calls for an additional 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* History of type 2 diabetes on medications
* Age 60 or older
* Able to attend local class 3 times per week for 10 weeks

Exclusion Criteria:

* Ejection fraction \<40%
* Symptomatic obstructive valvular disease (primarily aortic stenosis)
* Atrial fibrillation with poor rate control (particularly during exercise), or high grade AV block
* Substantial dementia (Folstein Mini Mental State Examination \<24 out of 30)
* Blood tests suggesting severe renal (Cr\>3.0) or hepatic (transaminases\>4x normal) disease
* Alcohol intake \>3 oz/day
* Hemiplegia or lower limb amputation
* Participating in regular exercise 2 or more hours per week.
* Significant orthopedic or musculoskeletal condition that limits weight bearing
* Acute medical conditions, such as acute flare-up of joint condition or infection
* Normal FBS in those with equivocal diabetes history (\< 130)
A Study of Rucaparib in Japanese Patients With a Previously-treated Solid Tumor

This is a Phase 1 open-label, dose-escalation, safety and pharmacokinetic study of rucaparib administered twice daily (BID) to Japanese patients with a solid tumor who have failed previous standard treatment for their cancer. A recommended dose of rucaparib for Japanese patients will be determined in a dose-escalation portion and then further evaluated in a dose-expansion portion of the study.


Eligibility Criteria:
Inclusion Criteria:

* Be 20 years of age at the time the informed consent form is signed and of Japanese ethnicity (ie, both parents are native Japanese and were born in Japan).
* Have a solid tumor that has progressed on standard treatment:

  * For patients enrolled in the dose-escalation portion, has confirmed solid tumor that is locally recurrent or metastatic
  * For patients enrolled in the dose-expansion portion, has high-grade serous ovarian cancer, or BRCA 1/2 mutated breast cancer, or other solid tumor with BRCA 1/2 or related gene mutation
* Have to have evaluable disease (i.e. disease can be followed on scans.)
* Be willing and able to fast for at least 14 hours

Exclusion Criteria:

* Active second malignancy
* Prior treatment with any PARP inhibitor
* Symptomatic and/or untreated CNS metastases
* Women who are breastfeeding or pregnant
* Pre-existing duodenal stent and/or any gastrointestinal disorder that would interfere with drug absorption
* Requires regular blood transfusions
Dose Study of Antithymocyteglobulin in Haploidentical Allogeneic Stem Cell Transplantation

The purpose of this study is to compare the incidences of GVHD in haploidentical hematopoietic stem cell transplant recipients receiving different dose of antithymocyte globulin (ATG) for acute graft-versus-host disease(aGVHD) prophylaxis. The investigators' first objective was to investigate the optimal dose of ATG for aGVHD.

Graft-versus-host diseases (GVHD) remains a major cause of morbility and mortality after allogeneic hematopoietic stem cell transplantation (HSCT) with grafts from an HLA-mismatched family donor. Antithymocyteglobulin (ATG) has been widely used to prevent acute GVHD (aGVHD) in haploidentical HSCT. Notwithstanding, immunosuppressive effect of ATG, which may also increase the risk of opportunistic infections, necessitates the use of the lowest possible dose. Till now, the optimal dose of ATG is not known. Here, the investigators compared the outcome of patients receiving haploidentical HSCT treated with two different doses of ATG.

Eligibility Criteria:
Inclusion Criteria:

* Haploidentical hematopoietic stem cell transplant recipient
* Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)