cyrilzakka/clinical-trials huggingface dataset:
Investigating a Well-being Review in Pulmonary Hypertension

Pulmonary Hypertension (PH) is a rare disease that makes patients easily become breathless. There is evidence that people with PH can benefit from exercise; we want to look at how they can access rehabilitation in their local community.

Aim: To see if it is feasible to study physiotherapy well-being reviews in PH. Step 1: We will interview some patients with PH who have had rehabilitation and ask questions about their experiences. We will also ask what they think we should measure to show any difference their rehabilitation has made to them. The findings from Step 1 will help us to shape the details of Step 2, where we will conduct a small study to see if it is feasible to run a full study. Participants will be divided randomly into a treatment group and a control group. The treatment group will have a physiotherapy well-being review, leading to referral to their most suitable local rehabilitation service and follow-up after 6 months. The control group will receive brief exercise advice and follow-up after 6 months. The findings will help to design a full study and be shared with patients and health professionals.


Eligibility Criteria:
Inclusion Criteria:

* in World Health Organisation (WHO) Functional Class II or III
* have a diagnosis of PH
* have started on PH drug therapy in the preceding 18 months
* showing no signs of worsening breathlessness or heart failure
* on an unchanged PH therapeutic regime for at least 6 months prior to inclusion.

Exclusion Criteria:

* have an active infection or acute exacerbation of lung disease
* have participated in a clinical study involving another investigation of drug, device or exercise within the previous 6 months
* are on a surgical or other pathway of care that has pre-determined physiotherapy or activity regimes or restrictions
* have any additional medical conditions that may adversely affect the safety of the subject or severely limit the lifespan of the subject
* have participated in rehabilitation in the last 12 months.
An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice

The purpose of this study is to explore the safety, efficacy, effects on quality of life (QOL), and biomarker response of ozanimod in participants with moderate to severely active ulcerative colitis (UC) in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of ulcerative colitis (UC), with signs and symptoms consistent with UC for at least 3 months prior to the first study intervention administration
* Moderate to severely active UC disease activity, defined as a modified Mayo score of 4 through 9, inclusive, with the following minimum subscores:

  i) An SF subscore ≥ 1, AND ii) An RB subscore ≥ 1, AND iii) An ES ≥ 2 (endoscopy performed within 60 days of the first study intervention administration).
* Report of a previous colonoscopy that documents extent of disease

Exclusion Criteria:

* Current or recent (within 3 months of screening) evidence of fulminant colitis, toxic megacolon, or bowel perforation
* Extensive colonic resection or current stoma
* Colonic dysplasia that has not been removed

Other protocol-defined inclusion/exclusion criteria apply
Auto/Allo Tandem Transplant for Relapsed B-NHL

The investigators plan to perform a retrospective review of patients with poor risk relapsed/refractory B-NHL having received HSCT and targeted immunotherapy at the Maria Fareri Children's Hospital between January 1, 2012 and June 1, 2015. The investigators will review the clinical records and collect the data with de-identified medical information from our HSCT clinical research database.

The investigators will obtain the following information from the patient's medical records: clinical factors including age at presentation, gender, clinical presentation, laboratory and pathology data, lymphoma diagnosis, clinical staging criteria, anti-cancer therapy as well as supportive care medicines, complications of therapy (adverse events graded from CTCAE v4.0), and hematopoietic stem cell transplantation therapy (chemotherapy, donor source, cell dose), course (engraftment, GVHD, chimerism), and follow-up (disease status).

Eligibility Criteria:
Inclusion Criteria:

* This analysis will include all children, adolescents, and young adults less than 29 years old with a histologically confirmed diagnosis of B-NHL treated at the Maria Fareri Children's Hospital

Exclusion Criteria:

* None
Sleep Health Enhancement in Older Adults to Address Frailty

The objective of the proposed study is to tailor a sleep health enhancement intervention to older adults and assess preliminary efficacy on reducing frailty in older adults. This pilot study will be conducted in two stages. In the treatment development stage, we will recruit n=10 older individuals age ≥65 with poor sleep health (≤ 7 on the Ru-SATED self-report questionnaire) to assess acceptability and tailor the sleep health enhancement intervention for older adults. In the pilot study stage to assess preliminary efficacy of the tailored sleep health enhancement intervention, n=30 older adults with poor sleep health will be randomly assigned to a 4-week 1x/week, telehealth-delivered sleep health enhancement intervention or to a wait-list control condition. Participants will wear wrist-worn actigraphy, complete sleep, frailty, and quality of life questionnaires at baseline and reassessments.


Eligibility Criteria:
Inclusion Criteria:

* ≥65 years old
* ≤ 7 on the RU-SATED self-report questionnaire
* MMSE ≥25 and AD8 \<3

Exclusion Criteria:

* Known untreated sleep disorder (such as sleep apnea or restless leg syndrome)
* \>3 on the STOP BANG indicating increased risk of sleep apnea
* Evidence of restless legs syndrome on RLS-Diagnosis Index
* Evidence of circadian rhythm sleep-wake disorder
* Evidence of parasomnia
* Regular use (\>2x/week) of prescription or over-the-counter medications to improve sleep
* Score of ≥15 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorse any suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)
* Score of ≥10 on the Generalized Anxiety Disorder (GAD-7) indicating moderate to severe anxiety
* Self-report of current or history (up to 2 years) of drug or alcohol abuse based on the DSM-V criteria
* History of nervous system disorder such as stroke or Parkinson's disease
* Severe mental illness such as schizophrenia or bipolar disorder
* Current or history (within 5 years) of shift work including hours of midnight-4am
* Is currently receiving a behavioral sleep health intervention
Clinical Study of Adipose Derived Mesenchymal Stem Cells for Treatment of Pulmonary Arterial Hypertension

Pulmonary arterial hypertension is a disease characterised by pathological changes in the pulmonary arteries leading to a progressive increase in pulmonary vascular resistance and pulmonary artery pressure. Right ventricular failure is the main cause of death in patients with pulmonary arterial hypertension, and the ability of the right ventricle to adapt to the progressive increase in pulmonary vascular resistance associated with changes to the pulmonary vasculature in pulmonary arterial hypertension is the main determinant of a patient's functional capacity and survival.Mesenchymal stem cells (MSCs)are a subset of adult stem cells residing in many tissues, including bone marrow(BM), adipose tissue, umbilical cord blood. Recent experimental findings have shown the ability of MSCs to home to damaged tissues and to produce paracrine factors with anti-inflammatory properties, potentially resulting in reduction of inflammation and functional recovery of the damaged tissues.It was found that MSCs can significantly improve the pulmonary hemodynamics, lung tissue gross and decrease the pulmonary artery pressure, middle artery thickness and right cardiac hypertrophy by intravenous injection.


Eligibility Criteria:
Inclusion Criteria:

（1）40-75years （2）Male or female （3）The patients that COPD with moderate to severe pulmonary hypertension (pulmonary systolic pressure more than 40mmHg)in relatively stable period （4）To preliminary assess the Patients'lifetime have more than 6 months （5）According to the researchers' judgment, they can abide by the research protocol or Volunteer to participate in the clinical study, understand the study procedure and sign the informed consent in person.

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Exclusion Criteria:

1. Patients with acute myocardial infarction and cardiac surgery in the past 1 month
2. Surgery may be required within 8 weeks
3. patients with prior pneumonectomy or having acute, chronic pulmonary embolism or other serious pulmonary diseases
4. Having a history of malignant tumor
5. Participated in other clinical investigators in the last 6 months
6. To allergic to penicillin, gentamicin, aminoglycoside, human serum albumin and DMEM medium
7. A woman who is planning to pregnancy, gestation, or lactation
8. Other reasons caused Pulmonary hypertension and heart failure caused by other causes;Severe liver and kidney failure;Autoimmune diseases;Patients with infectious diseases
9. According toThe researchers' judgments, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study
10. According to the researcher's judgment, this study is not suitable for other conditions -
S-ketamine Prevents Postoperative Pain and Cognitive Dysfunction After Tibial Fracture

Purpose:

To explore effects of S-ketamine on postoperative pain and cognitive dysfunction after tibial fracture and orthopedic surgery.

To evaluate and examine the incidence of adverse effects with the purpose of selecting the optimum dose.

With the increase in human life span, orthopedic injuries and subsequent repair surgery have become a major health problem which impairs the life quality of patients and burdens healthcare systems worldwide. Poor post-surgical pain control is a leading factor that hinders the physical rehabilitation and musculoskeletal functional recovery, and causes acute cognitive impairment and chronic pain syndrome. Also, existing treatments of opioids and non-steroidal anti-inflammatory drugs have potential drawbacks, which may in turn interfere with bone healing. Therefore, prophylaxis of fracture-associated pain is indispensable to postoperative comfort and satisfaction.

There is no denying the fact that pathologic pain is related to central glutaminergic system and N-methyl-d-aspartate (NMDA) receptor activation induced central sensitization. Also, we previously reported that neuroinflammation is associated with pain development and cognitive dysfunction. Ketamine, a NMDA receptor antagonist, is effective in reversing NMDA receptor activation underlying pain states. But the side effects of ketamine limit its clinical application, such as Delirium, gibberish and agitation. It is clarified that S-ketamine has lower side effects than ketamine and that antinociception of S-ketamine is stronger than ketamine. The following study is carried out to evaluate whether S-ketamine can prevent postoperative pain and cognitive impairment after tibial fracture and orthopedic surgery in patients.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is scheduled to undergo tibial fracture with orthopedic surgery under a short general anesthesia of less than 2 hours
2. Subject's American Society of Anesthesiologists physical status is I-II.
3. The subject's parent/legally authorized guardian has given written informed consent to participate.

Exclusion Criteria:

1. Subject has a diagnosis of bronchial asthma, coronary heart disease, severe hypertension, renal failure or liver failure.
2. Subject has a diagnosis of Insulin dependent diabetes.
3. Subject is allergy and contraindication to S-ketamine.
4. Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre- existing therapy with opioids.
5. Subject has any contraindication for the use of patient-controlled analgesia (PCA).
6. Subject is pregnant or breast-feeding.
7. Subject is obese (body mass index \>30kg/m\^2).
8. Subject is incapacity to comprehend pain assessment and cognitive assessment.
Pancreatic Stump Closure After Distal Pancreatic Resection

The aim of this study is to investigate whether finnish binding pancreatico-jejunal anastomosis is feasible and prevents the risk for post operative pancreatic fistula after distal pancreeatectomy.


Eligibility Criteria:
Inclusion Criteria:

* patiens which the distal pancreatic resektions
* the type of resections that is techically possible with finnish binding panceatico-jejunal anastomosis

Exclusion Criteria:

* if the pancreas is not suitable for this kind of anastomosis
Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP)

The clinical syndrome of PSP responds poorly to all available forms of therapy used in Parkinson's Disease (PD). Currently, no effective treatment exists. Coenzyme Q10 in high doses has been shown to be a beneficial therapy in PD and might possibly be a beneficial therapy for PSP. This study will compare the efficacy, safety and tolerability of Coenzyme Q10 versus placebo in patients with atypical parkinsonian syndrome, progressive supranuclear palsy (PSP).

The study is designed as a multicenter randomized, placebo-controlled, double blind trial. Up to 60 patients with PSP will be enrolled at several centers in the United States

Eligibility Criteria:
Inclusion Criteria:

* Patients fulfilling the diagnostic criteria of PSP/diagnosed within the past 5 years
* Either vertical supranuclear palsy or both slowing of vertical saccades
* Prominent postural instability with falls in the first year of disease onset
* No evidence of other diseases that could explain the foregoing features

Exclusion Criteria:

* Current or previous therapeutic use of CoQ10
* Parkinsonism due to drugs
* History of pallidotomy, thalamotomy, active deep brain stimulator or fetal tissue transplant
* History of active epilepsy, stroke, structural brain disease
* Use of methylphenidate hydrochloride, cinnarizine, reserpine, amphetamines, or monoamine oxidase-A inhibitors within 3 months before the baseline visit.
* Active cancer or cancer undergoing treatment
* Participation in other drug studies or the use of other investigational drugs within 30 days before screening.
* Known hypersensitivity to Coenzyme Q10.
* Pregnant, planning a pregnancy or nursing woman
Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program

The primary objective of this study is to establish a control population to assess performance of an investigational diagnostic test targeting lung neoplasms.

Subjects will be participating in a lung cancer screening program at enrollment. Subjects will have a blood sample collected within 60 days of a low-dose CT scan (LDCT). Subjects with nodules present on the LDCT or subjects with a clean LDCT scheduled for a 12-month follow-up may have another blood draw at 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is male or female, 50 years of age or older.
2. Subject meets one of two lung cancer screening criteria below.

   1. Subject is a candidate for LDCT lung cancer screening and is scheduled for a baseline LDCT scan. There may be circumstances when a patient cannot have an LDCT scan (e.g., due to insurance issues). In these cases, it is allowable for a patient to have a CT scan in order to meet the inclusion criteria. OR
   2. Subject has had previous LDCT scan(s) for lung cancer screening and the most recent LDCT scan prior to enrollment is negative for pulmonary nodules (Lung-RADS category 1, no nodules).
3. Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria:

1. Subjects with pulmonary nodules on the most recent LDCT scan prior to enrollment (Lung-RADS category 1 nodules with specific calcifications such as complete, central, popcorn, concentric rings and fat containing nodules are excluded).
2. Prior history of cancer within the past 5 years except for non-melanoma skin cancer.
3. Prior removal of the lung, excluding percutaneous lung biopsy.
4. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Registry Study of Clinical Application of MRI Compatible CIED

The purpose of this study is to clear the Safety and Necessity of the Magnetic Resonance Imaging (MRI) in the Presence of CIEDs(Cardiovascular Implantable Electronic Devices).


Eligibility Criteria:
1. Inclusion criteria

   * Patient is \>18 years old
   * Patient implanted with a Biotronik MRI compatible CIED (including the pacemaker, cardiac resynchronization therapy, implantable cardioverter defibrillator, and cardiac resynchronization therapy-defibrillator) in the past two months
   * Patient has provided a written informed consent
   * Patient's height is≥140cm
2. Exclusion criteria

   * Have other medical implants that may interact with MRI, e.g. abandoned pacemaker/ICD leads, lead extensions, mechanical valves, other active medical devices, non-MRI compatible devices
   * Life expectancy less than 2 years
   * Pregnant and/or breat-feeding females or females who intend to become pregnant in next two years
   * Patient is currently participating in another study
   * In the investigator's opinion patient will not be able to comply with the follow-up requirements
tDCS Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive Disorder

This is a single-center study about patients with severe resistant OCD.

Main assumption is that performing 10 tDCS sessions with the anode positioned at the level of the right orbitofrontal cortex, and the cathode at the level of the supplementary motor area, associated with the provocation of symptoms before each session is effective in the reduction in obsessive-compulsive symptoms.

After the inclusion visit, the treatment period is provided from D1 to D12 (one session per day from Monday to Friday, for two consecutive weeks, i.e. a total of ten sessions). Each tDCS session lasts 30 minutes at an intensity of 2 mA and is preceded by symptom provocation using a standardized procedure performed by trained personnel.

The patients are then assessed on D42 and D102 (i.e. 1 month and 3 months after the end of the tDCS sessions).


Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from OCD evolving for at least 2 years diagnosed according to DSM-V criteria;
* Patient with good insight, defined by a score less than or equal to 18 at the threshold of delusions on the BABS (Brown Assessment of Beliefs Scale) insight scale;
* Absence of a current depressive episode (MADRS score \< 21) or suicidal risk (MADRS score item 10 \< 3);
* Absence of epileptic pathology;
* Chronic obsessive-compulsive disorder defined by a total YBOCS score \> 20, or a subscale score \> 15;
* Drug-resistant obsessive-compulsive disorder despite treatment with:

  1. at least 2 antidepressants of the IRS type at an effective dose and for a sufficient duration
  2. and/or Behavioral and Cognitive therapy for at least 1 year;
* Therapeutic stability (antidepressants) for more than 12 weeks without significant improvement. This treatment, at a fixed dose, will be maintained during the study;
* Patient aged between 18 and 70 included
* Patient who has given his/her informed consent after having received written information on the planned procedure;
* Patient benefiting from social security or by benefiting through a third party.

Exclusion Criteria:

* Woman of childbearing age without effective means of contraception (hormonal/mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy)
* Pregnant or nursing woman;
* Patient hospitalized under duress (SPDT, SPDRE);
* Patient under guardianship or curatorship;
* Patient with another DSM-V Axis 1 diagnosis (Schizophrenic Disorder, Bipolar Disorder, Substance Abuse or Substance Dependence).

Generalized anxiety disorder, social phobia, nicotine addiction and history of major depressive episodes are not exclusion criteria. Axis I comorbidity will be explored using MINI 5.0.0. ;

* Patient suffering from a current depressive episode;
* Patient at risk of suicide;
* Patient with skin lesions on the scalp;
* History of head trauma;
* Patient with an intracerebral metal object
* Patient with a pacemaker;
* Presence of epileptic pathology;
* Patient in an emergency situation or unable to give personal consent
Neoadjuvant GTX With Chemoradiation for Pancreatic Cancer (Stage II/III)

This study is for patients with locally advanced pancreatic cancer (cancer that involves the local blood vessels so it cannot be removed without cutting major blood vessels) that cannot be treated with surgery. The purpose of this study is to assess the safety and benefit of 6 three week cycles of chemotherapy treatment consisting of gemcitabine, capecitabine and docetaxel (also called 'GTX'). The patients fall into two groups. Group I are those with only venous involvement. Group II patients have arterial involvement and may also have venous involvement. If there is arterial involvement, GTX will be followed by 5 and 1/2 weeks of radiation therapy with gemcitabine and capecitabine. After the chemotherapy and radiation treatment, participants may be able to have surgery to remove any remaining pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the pancreas (When possible the tissue should be evaluated for K-ras mutation and the patient evaluated for BRCA and p16 mutations.)
* Locally advanced disease determined by Endoscopic ultrasound, CT scan (chest/abdomen/pelvis with contrast), MRI scan (of abdomen with gadolinium) or PET scan.
* No evidence of metastatic disease by CT scan (chest/abdomen/pelvis with contrast), MRI scan (of abdomen with gadolinium) or PET scan.
* Unresectable tumor. (this reflects those patients whose tumors abut, invade or surround a major vessel, either venous or arterial or both)
* No prior chemotherapy or radiation therapy.
* Ineligible for other high priority national or institutional studies.
* Negative serum or urine β-HCG within 1 week of starting treatment for non-pregnant, non-menopausal females.
* Must not have other underlying medical conditions that would make them ineligible for surgery, radiation therapy, or chemotherapy.
* Complete Blood Count and Complete Metabolic Profile:

Absolute Neutrophil Count \> 1,500 μl White Blood Count \> 3,000/μl Platelet count \> 100,000/μl BUN \< 1.5 x normal Creatinine \< 1.5 normal Hemoglobin \> 8.0 g/dl Serum Albumin \> 3 mg/dl Total Bilirubin \< 3.0 mg/dl SGOT, SGPT, Alkaline Phosphatase \< 2.5 x ULN

* Informed consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the nature of this therapy, alternatives, potential benefits, side-effects, risks, and discomforts.