cyrilzakka/clinical-trials huggingface dataset:
Registry to Evaluate INOmax in Newborn Babies With Pulmonary Hypertension

Pulmonary hypertension is high blood pressure in the arteries to the lungs. It is a serious condition. It causes the blood vessels that carry blood from the heart to the lungs to become hard and narrow. When this happens, the heart has to work harder to pump the blood through.

Some babies are born with pulmonary hypertension (PH). Doctors might use INOmax (a gas the baby breathes) to help newborn babies (neonates) with PH. This study will use information from the records of registered babies to see how effective and safe INOmax is for treating premature and other newborn babies for up to 11 days after they are born.


Eligibility Criteria:
Inclusion Criteria:

1. Was either a P neonate born at least 27 weeks to less than 34 weeks of gestational age (GA) or a TNT neonate born at least 34 weeks but no more than 40 weeks of GA.
2. Was administered INOmax therapy after birth to 7 days of age via any route (invasive or noninvasive ventilation) for a minimum treatment period of at least 24 hours up to 96 ± 12 hours. The participants may receive INOmax for a longer period.
3. Had PH, as confirmed by echocardiogram or a differential saturation gradient of at least 10%.
4. Received INOmax administration as part of routine clinical practice in a Level III or higher neonatal intensive care unit in the United States.
5. Has all variables required to calculate OI or SOI (a baseline sample prior to treatment and 4 samples obtained during treatment).

Exclusion Criteria:

1. Was at risk of imminent death (death expected within 24 hours).
2. Received extracorporeal membrane oxygenation (ECMO).
3. Had a life-threatening abnormality (cranial, cardiac, thoracic), chromosomal abnormality, congenital diaphragmatic hernia, congenital heart defect (other than patent ductus arteriosus or small atrial septal defect).
4. Had been resuscitated requiring chest compressions within 6 hours of receiving INOmax.
5. Had Grade IV bilateral intraventricular hemorrhage or periventricular leukomalacia.
6. Had active uncontrolled bleeding.
7. Had disseminated intravascular coagulopathy.
8. Had active seizures while receiving anticonvulsants.
9. Experienced prolonged asphyxia with evidence of severe acidosis (pH \< 7.25).
10. Received concomitant pulmonary vasodilator therapy (eg, prostacyclin or sildenafil) except when sildenafil was used to wean the participant from INOmax therapy.
The Rolex Registry (Revascularization Of LEft Main With Resolute onyX)

The primary objective of this study is to assess the safety and efficacy of the new-generation zotarolimus-eluting stent Resolute Onyx in the treatment of unprotected left main coronary artery disease (ULMCAD), both isolated or in association with two- or three-vessel coronary artery disease.

The ROLEX study is a prospective, non-randomized, European, multi-center registry.

Four hundred and fifty patients with unprotected left main coronary artery disease (ULMCAD) will be enrolled at up to 40 European sites. The main objective of the study is to assess the safety and efficacy of the new-generation zotarolimus-eluting stent Resolute Onyx in the treatment of ULMCAD, both isolated or in association with two- or three-vessel coronary artery disease

Eligibility Criteria:
Inclusion Criteria:

* Subject \> 18 years old
* ULMCAD with angiographic diameter stenosis \>50% (if 50-70% evidence of FFR \<0.80 or IVUS minimal lumen area \<6.0 mm2 is recommended.
* Silent ischemia, stable angina, unstable angina or non-ST elevation myocardial infarction
* Ability to provide written informed consent and comply with follow-up for at least 2 years.

Exclusion Criteria:

1. Clinical exclusion criteria:

   * Prior PCI on the left main trunk or prior CABG.
   * Concomitant indication to cardiac surgery (severe heart valve disease etc.)
   * Cardiogenic Shock (Killip\>2)
   * Severe renal insufficiency (GFR \<30 ml/min)
   * Known impaired left ventricular function (left ventricular ejection fraction \<30%)
   * Inability to tolerate or comply with dual antiplatelet therapy for at least 1 year
   * Pregnancy or intention to become pregnant
   * Life expectancy less than 1 year
   * Other investigational drug or device studies that have not reached their primary endpoint
2. Angiographic exclusion criteria:

   * Left main diameter stenosis \<50%
   * SYNTAX score \>33
Effectiveness of Rosuvastatin at Preventing the Progression of Atherosclerosis in HIV Positive Patients

Rosuvastatin is a drug used to lower cholesterol, which also has other cardiovascular benefits. The goal of this project is to determine if rosuvastatin is effective at slowing the development of heart disease in people with HIV. We expect that after 2 years of treatment people treated with rosuvastatin will show significantly better results than people treated with a placebo.

HIV+ patients with at least one cardiovascular risk factor will be randomized to either rosuvastatin 10mg/day or placebo for a period of 96 weeks. B-mode carotid ultrasound will assess the primary outcome measure of average total thickness (a composite measurement of intima media thickness and total plaque area) at baseline, 24, 48, 72 and 96 weeks. We hypothesize that rosuvastatin will be significantly more effective with respect to inhibition of change in average total thickness between baseline and 96 weeks compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* HIV positive, at least one cardiovascular disease risk factor

Exclusion Criteria:

* Diabetes
* Previous vascular disease
* Muscular disease
* Current use of other lipid lowering therapy
Mindfulness Training Hidradenitis Suppurativa (HS)

The purpose of this research is to investigate the effectiveness of mindfulness training on the quality of life of Hidradenitis Suppurativa (HS) patients. HS can have a profound impact on quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Hidradenitis Suppurativa patients registered in the University of Miami Hospital dermatology system. Patients can have lesions present at the time of study participation

Exclusion Criteria:

* Individuals with any of the following: active drug addictions, untreated Post Traumatic Stress Disorder (PTSD), psychosis or suicidal ideations
* Adults unable to consent
* Pregnant women
* Prisoners
* Individuals below the age of 18 years old
* Individuals who do not speak English
Clinical Trial of Integrated Treatment for Pain and Opioid Dependence

This study is designed to develop an effective psychotherapy for chronic pain and opioid dependence.

This study aims to develop a novel manualized intervention using tailored cognitive-behavioral treatment (CBT) and buprenorphine medication to effectively treat the co-occurring disorders of non-malignant pain and opioid dependence (POD).

Specific Aims:

1. To conduct a pre-pilot phase with 16 patients with POD receiving buprenorphine maintenance treatment (BMT). In the pre-pilot phase, we will also explore the effects of different daily buprenorphine dosages on pain and opiate use.
2. To conduct a pilot randomized, clinical trial to obtain data regarding the feasibility, acceptability and efficacy (compared to Physician Management(PM) only) of manual-guided CBT or Educational Counseling (EC) for patients with POD treated with BMT (N=75).

The secondary outcomes: Development of a Treatment Manual and Development and Modification of Initial Therapy Training and Process Rating Measures were process measures and not been to be included as measures associated with RCT. These outcomes were removed when the RCT results were entered. In addition, outcomes were renamed for clarification.

At results entry, the timeframe (16 weeks) was also corrected to account for the actual timeframe used for analysis in the study. The 16-week study period listed in the protocol included a 2-week buprenorphine induction period (before randomization) and up to a 2-week post-conclusion of the clinical trial continuation on buprenorphine and referral to continuing treatment. In prior studies with buprenorphine, the study team had observed an artificially high attrition during the last 2 weeks of the planned study protocol, when participants were attempting to transition to available clinical treatments outside of the study. Consequently, as per the original study protocol for this study, the plan was to analyze intake and induction data (as baseline data) and then the data from the first 12-weeks post-randomization.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* prescription opioid addiction criteria
* moderate to severe chronic pain
* seeking or interested in buprenorphine maintenance
* understand English

Exclusion Criteria:

* methadone maintenance at a dose greater than 40 mg daily
* current suicide or homicide risk
* life-threatening or unstable medical problem
* pregnancy
Effect of Transcutaneous Electrical Stimulation on Post-stroke Dysphagic Patients

Oropharyngeal dysphagia (OD, swallowing dysfunction) is a major complaint following stroke. Despite its enormous impact on functional capacity, quality of life, and survival, OD is both underestimated and underdiagnosed as a cause of major nutritional and respiratory complications in stroke patients. A recent systematic review on the effects of rehabilitation therapy on OD concluded that although some positive effects were found, the number of studies was small, many of them had methodological problems and there was a need for further research using randomized controlled trials. Transcutaneous electrical stimulation was approved by the FDA as a treatment of dysphagia in June 2001 and is traditionally used to activate pharyngeal muscles through stimulation of peripheral motor nerves (neuromuscular electrical estimulation, NMES). However, their real effectiveness and safety in the treatment of dysphagia is still matter of discussion (Logemann Dysphagia 2007, Ludlow dysphagia 2007) and studies evaluating NMES therapy, present discordant results. On the other hand, in recent years, transcutaneous electrical stimulation is beginning to use as a sensory strategy (Gallas 2010), avoiding muscle contraction during the treatment.Our research strategy includes the assessment of the therapeutic effect of these two main strategies using transcutaneous electrical stimulation on swallow physiology and clinical outcomes of post-stroke dysphagic patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Background of swallowing difficulties associated with stroke, more than 3 months of evolution
* Study explained and signed informed consent

Exclusion Criteria:

* Patients who are suspected or can not meet the protocol. patients who are participating or have participated in a trial last 4 weeks. Patients with active cancer Patients with active infectious process. patients with severe dementia or inability to communicate. patients with neurodegenerative diseases. patients with pacemakers. patients with implanted electrodes. patients with epilepsy or seizure disorders. patients with gastroesophageal reflux.
Bioequivalence Study (Candesartan 8 mg and Amlodipine 5 mg)

The purpose of this study is to compare the safety and pharmacokinetics of CKD-330 (fixed-dose combination of Candesartan 8 mg and Amlodipine 5 mg) with coadministration of the two separate drugs in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male volunteer in the age between 20 and 45 years old.
2. Body weight ≥ 55 kg and Body weight in the range of calculated IBW ±20%.
3. Subjects without a hereditary problems and chronic disease.
4. Subjects whose clinical laboratory test values are inside the accepted normal range.
5. Understand the requirements of the study and voluntarily consent to participate in the study.

Exclusion Criteria:

1. Previous history or present of clinically significant hepatobiliary, nephrological, neurologic, respiratory, hemato-oncological, endocrine, urogenital, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system.
2. History of gastrointestinal disease or gastrointestinal surgery to affect drug absorption.
3. History of clinically significant allergies of amlodipine or candesartan or CCB or ARB or aspirin or antibiotic.
4. Subjects with galactose intolerance.
5. SBP ≥ 140 mmHg or\< 90 mmHg, DBP ≥ 95 mmHg or \< 60 mmHg, pulse ≥ 100 BPM.
6. AST or ALT \> 2\*ULN, total bilirubin \> 2\*ULN
7. Serum Creatinine \> ULN
8. Previous history or present of drug abuse.
9. Subjects treated metabolizing enzyme inducers or inhibitors such as barbitals within 1 month prior to the first dosing.
10. Subjects treated ethical drug or herbal medicine within 2 weeks, OTC or vitamin within 1 week prior to the first dosing.
11. Subjects treated IP within 2 months prior to the first dosing.
12. Subjects with whole blood donation within 2 months or component blood donation within 1 month or blood transfusion within 1 month prior to the first dosing.
13. Alcohol \> 21 units/week or cannot stop drinking.
14. Cigarette \> 10 cigarettes/day.
15. Subjects with the plan dental treatment(extraction, orthodontic, nerve treatment) or any surgery(plastic surgery, eye surgery - LASIK, LASEK).
16. Not eligible to participate for the study at the discretion of investigator.
Combination or Sequential Therapy of Peginterferon Alfa-2a and Entecavir for Patients With Chronic Hepatitis B

Currently, seven medications are approved for the treatment of hepatitis B: two formulations of interferon and five nucleons(t)ide analogues. The current treatment strategy of chronic hepatitis B is now standard: initial selection of entecavir, tenofovir, or peginterferon alfa-2a (peg-IFNα-2a). Interferon is administered for a finite duration while nucleotide analogues are usually administered for many years. But among hepatitis B e antigen （HBeAg） positive patients with high serum hepatitis B virus DNA levels, the rates of virological response are poor. And antiviral drug resistance is a major limiting factor to the success of nucleotide analogue treatment. Therefore, combination therapy using peginterferon with an oral agent with a high genetic barrier to resistance might be superior to standard current monotherapy. However, the addition of lamivudine to peg-IFNα-2a therapy led to a greater decrease in serum HBV DNA levels during treatment but did not increase the rate of HBeAg sero¬conversion. Entecavir is a nucleoside analogue superior to lamivudine and adefovir in achieving higher virological response, histological improvement and normalisation of ALT. Moreover, Entecavir has a high genetic barrier with a very low incidence of drug resistance. This study is aimed to investigate the efficacy of combination or sequential therapy using peg-IFNα-2a and entecavir in HBeAg-positive chronic hepatitis B(CHB) patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age≥16 years
2. HBsAg positive for more than 6 months, and HBeAg detection is positive for two times in 6 months before enrollment
3. Serum HBVDNA \>2×10\^4IU/ml
4. 80U/L \< serum ALT \< 400U/L, and TBIL \< 34 umol/L
5. Serum ALT \< 80U/L, but hepatic inflammation scores ≥ G2 or hepatic fibrosis stage ≥ S3

Exclusion Criteria:

1. Co-infected with HCV, HDV or HIV, or autoimmune liver diseases combined
2. Hepatic decompensation
3. received antiviral therapy or immunosuppressant drugs before 6 months prior to enrollment
4. Blood routine examination: WBC \<3×10\^9/L，neutrophile granulocyte \< 1.5×10\^9/L，PLT \<80×10\^9/L
5. Renal function: creatinine \>1.5 times of upper normal limit
6. Alcoholism or a history of addiction and abuse
7. Combined with hepatocarcinoma
Topical Bimatoprost in the Treatment of Migraine

The study is to assess the effectiveness of topically applied bimatoprost in reducing migraine headache frequency, severity, and duration. It will also assess the effect of topical bimatoprost on quality of life.

Hall, et al. have observed retrospectively that treatment with topical prostaglandin F2 alpha analogs (applied either to the eye or fingernail bed) significantly reduced the frequency, severity and duration of headaches in migraine sufferers, as well as their migraine disability assessment score (MIDAS).

This is a double-blind, placebo-controlled prospective clinical study to determine if the effect of FDA-approved bimatoprost, a prostaglandin F2 alpha analogue, has anti-migraine activity when administered topically to people suffering from migraine.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of migraines based on International Classification of Headache Disorders (ICHD) II criteria and experiencing headaches for 4 or more days per month.

Exclusion Criteria:

* Significant liver or renal dysfunction,
* On treatment for inflammatory bowel disease, medication over-use for headaches according to the ICHD II criteria,
* Use of antipsychotics in the past month,
* Recent (in the past six months) history of alcohol or drug abuse,
* Allergy to bimatoprost and its compounds,
* Severe comorbid psychiatric illness,
* Severe infection,
* Malignancy,
* Severe cardiovascular disease,
* Neurodegenerative disorders,
* Pregnancy and lactation, and
* Sexually active women of child bearing age who do not use any method of contraception.
Azacitidine in Treating Patients With Newly Diagnosed Previously Untreated or Secondary Acute Myeloid Leukemia Who Are Unsuitable For Intensive Chemotherapy

RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well azacitidine works in treating patients with acute myeloid leukemia who are unsuitable for treatment with intensive chemotherapy.

OBJECTIVES:

Primary

* To evaluate the efficacy of azacitidine in patients with newly diagnosed or untreated acute myeloid leukemia who are unsuitable for induction type chemotherapy because of age or relevant comorbidities.

Secondary

* To evaluate survival and adverse events.

OUTLINE: This is a multicenter study.

Patients receive azacitidine subcutaneously on days 1-5. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of 1 of the following:

  * De novo acute myeloid leukemia (AML)
  * AML secondary to prior hematological disease or cytotoxic treatment
* Newly diagnosed or untreated disease
* At least 20% blasts in the blood or bone marrow or extramedullary disease
* Must be considered unsuitable for intensive chemotherapy due to ≥ 1 of the following:

  * High age or frail for the biologic age
  * Relevant comorbidities
  * Unwilling to undergo intensive chemotherapy
* No chronic myelogenous leukemia or acute promyelocytic leukemia

PATIENT CHARACTERISTICS:

* WHO performance status 0-3
* Bilirubin ≤ 3 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2.5 times ULN
* AST ≤ 2.5 times ULN
* Serum creatinine ≤ 2.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 12 months after completion of study treatment
* Patient compliance and geographic proximity allow proper staging and follow-up
* No NYHA class III-IV heart failure or relevant cardiac arrhythmia
* No active hematological/oncological disease other than AML
* No psychiatric disorder precluding understanding of information on trial related topics or giving informed consent
* No serious underlying medical condition in the judgment of the investigator, which could impair the ability of the patient to participate in the trial, including but not limited to, any of the following:

  * Active autoimmune disease
  * Uncontrolled diabetes
  * Active uncontrolled infection
  * HIV infection
  * Active chronic hepatitis B or C infection
* No known allergy or hypersensitivity to azacitidine or mannitol

PRIOR CONCURRENT THERAPY:

* No prior treatment for AML
* No prior azacitidine or decitabine
* No other concurrent experimental or investigational drugs or anticancer therapy
* More than 30 days since participation in another clinical trial
* No concurrent growth factors for use in afebrile and asymptomatic patients except to treat neutropenic infection
Targeting Mitochondrial Fusion and Fission to Prevent Atherosclerosis: Getting the Balance Right

Our preliminary data suggests that pharmacological inhibition of the mitochondrial fission protein, Drp1, reduced atherosclerotic plaque volume and attenuated macrophage accumulation within the plaque in an ApoE-/- mouse model of wire-induced carotid arterial injury. Furthermore, we hypothesize that modulation of mitochondrial morphology and metabolism with Drp1 inhibition prevents atherosclerosis by reducing monocyte activation and migration. In this research proposal, our overall objective will be to investigate the role of Drp1 in human monocytes and macrophages as novel therapeutic targets for preventing atherosclerosis.

Study 1 (tissue sample study): To investigate the changes in mitochondrial function and pro-inflammatory markers in human arterial atherosclerotic plaques.

Hypothesis: Macrophages from femoral artery atherosclerotic plaques in patients with peripheral artery disease will display upregulation of mitochondrial fission proteins and features of pro-inflammatory activation.

Study 2 (white blood cell study): To investigate the changes in mitochondrial function and pro-inflammatory markers in white blood cells from patients with stable and unstable coronary artery didease (CAD).

Hypothesis: Monocytes from patients with unstable CAD will display upregulation of Drp1 and features of pro-inflammatory activation, mitochondrial fission, impaired mitochondrial respiratory function, and perturbed metabolism, when compared to monocytes from patients with stable CAD.

Eligibility Criteria:
Inclusion Criteria:

Study 1 (tissue sample study):

CABG patients

1. Patients aged ≥21 years old
2. Undergoing elective CABG with aortic valve surgery

PAD patients:

1. Patients aged ≥21 years old
2. Undergoing either elective surgical femoral or carotid endarterectomy

Study 2 (white blood cell study):

1) Healthy volunteers aged ≥21 years old 2) Patients with stable CAD 3) Patients admitted with ACS treated by PCI in prior 24 hours.

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Exclusion Criteria:

1. General exclusion criteria will be a known history of leucopenia, thrombocytopenia, or severe hepatic or renal dysfunction, as well as evidence for inflammatory or malignant disease.
2. History of haematological disorders
3. Cardiac arrest, Cardiogenic shock, Poor pre-morbid status, Pregnancy