cyrilzakka/clinical-trials huggingface dataset:
PHENOTYPE. Therapeutic Study in Barcelona

The study aimed to explore therapeutic effects of natural environments. To do so, the investigators evaluated the immediate and sustained changes in several indicators of well-being while people (n=26) with poor mental health were engaged in unconstrained exposures to natural (green, blue) and urban environments. The indicators included: affection, cognition, physiological responses.

Each participant was exposed to all environments for a period of 210 minutes between October 2013 and January 2014. During the exposure period, participants were instructed to do what they would usually do in that environment. Before, during (at 30 and 210 minutes) and after each exposure, several psycho-physiological measures were taken: (i) heart rate variability and heart rate using a Holter monitor, (ii) blood pressure using a digital blood pressure monitor, (iii) physical activity using the CalFIT application installed in a Smartphone, (iv) lung function using a portable computerized spirometer, (v) stress level using salivary cortisol samples collected using Salivettes, (vi) affect, perceived restoration and social interactions using questionnaires, (vii) cognitive functioning using the backwards digit-span task test.


Eligibility Criteria:
Inclusion Criteria:

* MHI-5 scored in the lower 50th percentile of the Barcelona city PHENOTYPE sample
* willing to participate

Exclusion Criteria:

* no able to walk for 30 minutes at self-directed pace.
* with chest, abdomen surgery or heart attack during the last three months.
* with retinal detachment or eyes surgery or hospitalized for heart problem during the last month.
* with tuberculosis treatment, or respiratory infection during the last three weeks.
* being asthmatic or pregnant
* using inhaler the 24 hours previous to the study day.
* taking medication different from the usual the 24 hours previous to the study day.
Endoscopic Treatment of Gastroesophageal Reflux Disease

Gastroesophageal reflux disease (GERD) occurs when stomach acid repeatedly flows back into the tube connecting your mouth and stomach (esophagus). This backwash (acid reflux) can irritate the inner lining of the esophagus. This is a particular problem after surgery to reduce obesity called gastric sleeve resection.

The goal of this small clinical trial is to examine the effect of endoscopic treatment of GERD by mucosal band ligation. The main questions it aims to answer are:

* Does the treatment affect gastroesophageal reflux assessed by measuring gastroesophageal reflux
* Does the treatment affect gastroesophageal reflux symptoms and ability to stop treatment with medication commonly used (proton pump inhibitors)

Participants (n=12) will be asked to undergo 24 h reflux examination and report symptoms of GERD. Suitable patients will be offered endoscopic treatment with band ligation of the inner lining of the lower esophagus and upper part of the stomach. The effects will be assessed three and six months after the procedure.

Gastroesophageal reflux disease (GERD) is very common after gastric sleeve resection and many patients are dependent on daily use of proton pump inhibitors (PPIs). The goal of this small clinical trial is to examine the effect of endoscopic treatment of GERD by mucosal band ligation.

Patients (n=12) with GERD satisfying inclusion and exclusion criteria will be invited to participate and the degree of gastroesophageal reflux will be assessed before treatment, and three and six months after the procedure. The results of the trial will be used to plan a larger study.

Eligibility Criteria:
Inclusion Criteria (all criteria must be fulfilled):

* Previous gastric sleeve resection
* GERD. GERD must be diagnosed by either endoscopic esophagitis or esophageal pH measurement with DeMeester score \> 14.72 and pH \<4 more than 4% of a 24-h period and symptom association probability (SAP) \> 95%
* Subjective insufficient symptom control with PPI therapy once daily or intolerance to PPI or desire to stop PPI treatment and therefore willingness to undergo endoscopic treatment.

Exclusion Criteria:

* Hiatal hernia \> 5 cm
* Age \< 18_years
* Preexisting esophageal stricture
* Gastric stricture \< 2 cm in diameter
* Anti-coagulant medication
* Use of platelet inhibitors other than acetylsalicylic acid
* Manometric indication of motility disorder
* Connective tissue diseases
* BMI \> 35
* Liver cirrhosis
* Coronary heart disease
* Chronic obstructive pulmonary disease
* Other significant comorbidity
* Indication for long-term PPI use other than GERD
"Fit For Kids"-Copenhagen

This study aims to evaluate the effect of a 40- week multifactorial intervention against overweight, obesity and physical inactivity in Danish children.

The investigators wish to examine 40 children before and after the "Fit for Kids" intervention with basic anthropometric measures such as body mass indexi (BMI), waist/hip ratio, systolic- and diastolic blood pressure, level of physical fitness and Total Body fat mass.

Furthermore the investigators wish to examine the more specific inflammatory, metabolic and hormonal effect of the intervention with a more extensive examination programme.

The tests include a DXA-scan, cardio-respiratory fitness, accelerometer monitoring, pedometer monitoring, cognitive testing, Continuous Glucose Monitoring System, different metabolic and inflammatory markers and an oral glucose tolerance test. The study will take place at Centre of Inflammation and Metabolism, Rigshospitalet, Copenhagen.

The study is a randomised controlled trial with a gradual rollout. The 40 children will be randomised. Twenty children will start the intervention at baseline and 20 children will start after the first 20 weeks of intervention, thus providing a control group.

The investigators expect to find a significant reduction in BMI, total body fat mass and systolic blood pressure after the intervention. As for the more extensive tests, the data approach is explorative, as the investigators look at more statistical dependent variables. The contribution of this project is a further description on the effect of intervention against overweight and physical inactivity on the metabolic and inflammatory response.


Eligibility Criteria:
Inclusion Criteria:

* Obese children

Exclusion Criteria:

* Other chronic medical conditions
* Medical intake
Comparison of Three Confirmatory Tests in the Diagnosis of Primary Aldosteronism

To compare the diagnostic value of three confirmatory tests for primary aldosteronism.

This is a prospective study involving 240 hypertensive patients who underwent primary aldosteronism screening. Every patient will undertake four confirmatory tests to compare the diagnostic accuracy of the oral sodium loading test with captopril challenge testing (CCT) and Seated saline infusion test(SSST)using the fludrocortisone suppression testing (FST) as the reference standard, and to investigate the optimal cutoff of oral sodium loading test

Eligibility Criteria:
Inclusion Criteria:

1. hypertensive patients with ARR≥10(pg/ml)(uIU/ml)
2. hypertensive patients with ARR\<10(pg/ml)(uIU/ml) but suspicious of PA clinically

Exclusion Criteria:

1. Pregnancy or lactation;
2. Child-bearing women refuse to take effective contraceptive measures;
3. History of malignant tumor;
4. Patients with cardiovascular and cerebrovascular diseases (eg. myocardial infarction, acute heart failure, stroke), in the past 3 months
5. NYHA III (New York Heart Association)and above
6. Hypohepatia
7. Chronic kidney disease with an estimated Glomerular Filtration Rate \<30ml/min/1.73 m²
8. Severe arrhythmia by ECG or severe heart disease by cardiac ultrasound
9. Patients who are unwilling to participate in and complete this study and refuses to sign the informed consent form for this study
N-3 Polyunsaturated Fatty Acids in the Prevention and Treatment for IFN-induced Depression

The first part is a double-blind placebo-controlled trial to identify the effects of omega-3 polyunsaturated fatty acids (PUFAs) in prevention of IFN-induced depression. The second part is a double-blind trial to identify the antidepressant effects of omega-3 PUFAs in patients with IFN-induced depression.

We have done a preliminary analysis in 63 HCV patients receiving IFN-α therapy enrolled in our current NSC project (NSC95-2320-B-039-037-MY3) and found that patients who later developed IFN-α-induced depression (case group, 21/63) had lower PUFA levels before starting IFN-α therapy than control group (p=0.024). In addition, there was a trend for a negative correlation (r=-0.224; p=0.078) between baseline DHA levels and the highest scores of BDI during IFN therapy in the whole group. These findings indicate that n-3 PUFAs might play a protective factor.

This 3-year proposal is divided into 2 clinical studies. In study 1, we aim to test the prophylactic effect of n-3 PUFAs (EPA: 3.5 g/d and DHA: 1.75 g/d versus placebo: high oleic oil) for IFN-α-induced sickness behaviour and depressive symptoms, in a two-week, double-blind, placebo-controlled trial of 152 patients with HCV starting IFN-α therapy. In study 2, we will test the antidepressant effect of n-3 PUFAs (EPA: 3.5 g/d and DHA: 1.75 g/d versus placebo: high oleic oil) on IFN-α-induced depression during IFN-α therapy, in an eight-week, double-blind, placebo-controlled trial in 80 HCV patients who have already developed depression.

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants will be adult patients with chronic HCV, assessed by hepatologists and then referred for IFN-α therapy and have capacity and willingness to give written informed consent

Exclusion Criteria:

* Patients will be excluded if they have major depressive episode at assessment
* Any history of pre-existing psychotic disorders (e.g. schizophrenia or bipolar disorder)
* Alcohol or drug dependence within one year before entry into the study
* Seizure disorders and evidence of any unstable substantial coexisting medical conditions (e.g. cardiovascular, endocrine, haematological, renal, or neurological diseases)
Observational Study of HIV Infection in Participants of Seroconvert During Dapivirine Vaginal Ring Trials

The purpose of this trial is to determine if exposure to ARV-containing investigational products in IPM clinical trials will impact the natural history of HIV infection as measured by the virologic, immunologic and clinical outcomes of participants who become HIV-positive during the IPM 027 trial.


Eligibility Criteria:
Inclusion Criteria:

* Recent HIV seroconversion during participation in IPM 027, according to the HIV testing algorithm of that trial
* Ability and willingness to provide informed consent
* Willingness to give the research centre permission to share information with the primary health care provider (PHCP), and willingness to sign approved site-specific documentation to facilitate such sharing.

Exclusion Criteria:

* Any condition that, in the opinion of the Investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
MATRIX: Measuring Neutralizing Antibodies in the Patients Treated With Interferon Beta 1a IM, in Mexico and Colombia

This is a cross sectional Phase 4, multicenter, study of AVONEX® and JUMTAB® to determine the frequency of IFN induced Neutralizing Antibodies (Nabs). A secondary component is the long term retrospective observational evaluation conducted to measure efficacy, adherence to therapy, tolerability, and safety in subjects with relapsing MS related to antibody status and treatment.

The primary objective of this study is to evaluate the frequency of neutralizing antibodies in patients treated with IFN beta 1a IM (Avonex) and IFN beta 1a IM biosimilar formulation (Jumtab).

Secondary objectives:

* Evaluate the effect of Nabs on the severity of the relapses on each treatment group, measured by:

  * The need and duration of steroid courses
  * The need and duration for hospitalization.
* To evaluate the safety and tolerability of the IFN beta 1a IM treatments \[Avonex and Jumtab\].
* To identify the genetic profile of the patients with relation to the predisposition to Nab development (HLA DR4 (in particular HLADRB1\* 0401 and 0408) and DR16 (in particular HLADRB1\* 1601)
* At selected sites: To evaluate the influence of the interferon and the Nabs on the activation of neopterin

Eligibility Criteria:
Inclusion Criteria:

* To be eligible for entry into this study, candidates must meet all of the following eligibility criteria at the time of selection:

  * No limitation of age, EDSS or other disease parameters will be applied.
  * Subject with MS
  * Subjects treated with IFN beta 1a IM (Avonex) or the biosimilar formulation of IFN beta 1a IM (Jumtab) in line with the local prescription information
  * The IFN beta 1a IM (Avonex or Jumtab) treatment should be the first disease modifying treatment
  * The subject should be treated with the same drug for at least 18 months and up to a maximum of 3 years

Exclusion Criteria:

* Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of selection:

  * No informed consent
  * Patients with combination therapy (IFN + immunosuppressive therapy)
  * Patients pretreated with immunosuppressive therapy
  * Treatment with any investigational product, including investigational symptomatic therapies for MS (e.g., 4Aminopyridine) and investigational therapies for NonMS indications, during the review period.

NOTE: subjects may receive investigational symptomatic therapies for MS at any time prior to evaluation period.
Treatment Duration on Normobaric Hyperoxia in Acute Ischemic Stroke

Normoxia Hyperoxia (NBO) is a neuroprotective approach that can be implemented early. NBO is simple and non-invasive and can be used at home or in an ambulance to ensure the shortest possible time after cerebral ischemia occurs. The previous study by the investigators suggested that NBO therapy in the early stage of cerebral ischemia has a neuroprotective effect on ischemic brain injury. Although the neuroprotective effect of NBO has been demonstrated, the optimal duration of treatment for NBO to exert neuroprotective effect is still unclear. Therefore, further discussion of the duration of NBO treatment will contribute to the clinical application of NBO and provide a definite theoretical basis for the treatment of cerebral infarction.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms and signs were consistent with acute anterior circulation stroke,
* NIHSS score≥6分;Alberta Stroke Program Early CT score (ASPECTS)≥6;
* Met the indications for endovascular therapy;
* (Level of consciousness)NIHSS score 0 or 1; MRS score was 0-1 before stroke
* The time from onset to randomization was within 24 hours;
* Preoperative CTA or MRA confirmed the presence of large vessel occlusion (internal carotid artery or middle cerebral artery M1, M2 segments);
* Patients and their families signed informed consent

Exclusion Criteria:

* Rapid neurological function improvement, NIHSS score less than 10 points, or evidence of vessel recanalization prior to randomization;
* Seizures at stroke onset;
* Intracranial hemorrhage;
* Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal;
* Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with INR \> 3.0 or PTT \> 3 times normal;
* Platelet count of less than 100,000 per cubic millimeter;
* Severe hepatic or renal dysfunction;
* Severe, sustained hypertension (Systolic Blood Pressure \>185 mmHg or Diastolic Blood Pressure \>110 mmHg)
* Baseline blood glucose of \<50mg/dL (2.78 mmol) or \>400mg/dL (22.20 mmol) Active and chronic obstructive pulmonary disease or acute respiratory distress syndrome;
* \>3 L/min oxygen required to maintain peripheral arterial oxygen saturation (SaO2) 95% as per current stroke management guidelines;
* Medically unstable;
* Life expectancy\<90 days;
* Patients who could not complete the 90-day follow-up;
* Evidence of intracranial tumor;
* Patients with anemia or polycythemia vera or other situations that require urgent oxygen inhalation;
* Patients with upper gastrointestinal bleeding or nausea or vomiting so that they cannot cooperate with the mask to inhale oxygen.
* A history of severe allergies to contrast agents;
Atorvastatin Plus Ezetimibe on Coronary Plaque Progression

Atherosclerosis is a progressive disease. Lipid lowering therapy was the standard treatment for patients with coronary artery disease. Studies indicated that coronary artery plaque progression had positive relationship with the plasma cholesterol level, and could be halted or reversed by intensive statin therapy (such as 20-40 mg/d atorvastatin). Ezetimibe plus statin could further lowered blood cholesterol level. Here the investigators hypothesize that same cholesterol lowering level by routing dose of atorvastatin or lower dose of atorvastatin plus ezetimibe could achieve the same effect on coronary artery plaque cessation or regression.


Eligibility Criteria:
Inclusion Criteria:

* Willing to receive the coronary angiography and potential PCI therapy

Exclusion Criteria:

* Patients was treated by statins before randomization
* Patient with ≤ 20% and ≥ 70% coronary narrowing and target lesion
* ST elevation myocardial infarction less than 7 days
* Without informed consent
* Abnormal liver function before randomization, (AST, ALT ≥ULN)
* Active hepatitis or muscular disease
* Impaired renal function with serum creatinine level \> 3mg/dl
* Impaired left ventricular function with LVEF \> 30%
* Participate in other studies
POA Retrospective Repository

This repository is a multi-center, outcomes study designed to retrospectively collect data on the demographics, presentation, diagnosis, treatment, cost of associated care, quality of life, and outcomes of subjects utilizing Caris Molecular Intelligence® (CMI) Services for the treatment of cancer. Prior to enrolling a subject, the subject's physician will have made the independent decision whether or not to utilize the drug associations provided by CMI and made clinical treatment choices as appropriate. Thus, data captured and reported provides a "real world" perspective on diagnosis, treatment, cost, and outcomes.

This repository is a multi-center, outcomes study designed to retrospectively collect data on the demographics, presentation, diagnosis, treatment, cost of associated care, quality of life, and outcomes of subjects utilizing Caris Molecular Intelligence® (CMI) Services for the treatment of cancer. Prior to enrolling a subject, the subject's physician will have made the independent decision whether or not to utilize the drug associations provided by CMI and made clinical treatment choices as appropriate. Thus, data captured and reported provides a "real world" perspective on diagnosis, treatment, cost, and outcomes.

Patients who have had CMI testing prior to the initial IRB submission date of November 11, 2016 for the respective site would be eligible to have their treatment and treatment response data entered into the study Database. All entered data would be de-identified. The patient's CMI biomarker results and treatment response data will be coupled together in order to allow the investigation of research questions concerning biomarker status and treatment response.

Eligibility Criteria:
Inclusion Criteria:

* Subject' s age must be greater than or equal to 18 years and must have received CMI testing prior to the initial protocol IRB submission date of November 11, 2016.

Exclusion Criteria:

* Due to the complexity of state and federal requirements governing the participation of prisoners in research, prisoners-patients shall not be approached for participation.
International, Multicenter, Open-Label and Randomized Withdrawal Study of Oral Lixivaptan in Heart Failure Patients With Chronic Hyponatremia

To demonstrate that after 12 weeks of open-label lixivaptan treatment, serum sodium is maintained in hyponatremic patients continuing to receive lixivaptan compared to placebo during the 4 week double blind treatment period.


Eligibility Criteria:
Inclusion Criteria:

1. Men and Women with age greater than or equal to 18 years.
2. Prior successful participation in a randomized, blinded, placebo-controlled Phase 3 lixivaptan study of hyponatremia in Heart Failure (Protocol CK-LX3401) with evidence of continued need for therapy as follows:

   * Patient completed full course of treatment (e.g., either placebo or lixivaptan). Treatment assignments for Protocol CK-LX3401 will not be unblinded prior to participation in the extension study.
   * Baseline serum sodium concentration \< 135 mEq/L following a 30 day post treatment follow-up period in a lixivaptan hyponatremia parent trial. Repeat measures of serum sodium are allowed; the last serum sodium result within 24 hours prior to randomization will serve as the qualifying measurement.
3. The patient has clinical evidence of volume overload with at least one of the following:

   * Dyspnea
   * Pulmonary congestion (rales)
   * Peripheral edema
   * Increased jugular venous pressure and/or hepatic congestion with ascites
   * Chest x-ray consistent with CHF; OR
   * Plasma BNP ≥150 pg/mL or NT pro-BNP ≥ 450 pg/mL

Exclusion Criteria:

1. Women who are pregnant (positive pregnancy test), breastfeeding or who will not adhere to the reproductive precautions as outlined in this protocol and in the informed consent form.
2. Inability to provide informed consent.
3. Acute severe hyponatremia with overt symptoms of hyponatremia requiring immediate medical intervention (e.g., coma, seizures).
4. Acute or transient hyponatremia (e.g., associated with head trauma or postoperative state).
5. Hyponatremia in hypovolemic states. Hypovolemia is defined as the presence of clinical evidence of fluid volume depletion.
6. Euvolemic Hyponatremia (e.g., SIADH, etc.). Euvolemic hyponatremia is defined as low serum sodium in the presence of normal total body sodium due to mild to moderate increases in total body water without edema.
Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year

The objective of this study was to obtain long-term sustained clearance rates for subjects previously treated with imiquimod creams in studies GW01-0702, GW01-0703, GW01-0704 and GW01-0705.

This is a Phase 3 longitudinal and observational study. Subjects who previously enrolled in studies GW01-0702, GW01-0703, GW01-0704, and GW01-0705 and were completely cleared of their AK lesions in the selected treatment area at the end-of-study visit will return for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.

The NCT numbers for the above mentioned studies are:

NCT00603798 - for Studies GW01-0703 and GW01-0705

NCT00605176 for Studies GW01-0702 and GW01-0704

Eligibility Criteria:
Inclusion Criteria:

* Are willing and able to give informed consent;
* Have successfully completed one of the following studies: GW01-0702, GW01- 0703, GW01-0704, or GW01-0705 and have been determined to be completely clear of AK lesions at the EOS visit in the designated treatment area from the previous study
* Are willing to participate in the study as an outpatient, make visits to the study center for follow-up evaluation, and agree to comply with all study requirements.

Exclusion Criteria:

* None. All subjects who meet the inclusion criteria above may participate.