cyrilzakka/clinical-trials huggingface dataset:
Deaf Weight Wise 2.0: A Healthy Lifestyle Intervention With Deaf Adults Who Are Overweight or Obese

The purpose of the Deaf Weight Wise 2.0 (DWW 2.0) study is to test an evidence-based, comprehensive program to modify obesity-related health behaviors with Deaf people ages 21 to 70 who use American Sign Language (ASL) as their primary language. Participants will be randomized to one of four arms: immediate intervention vs. intervention delayed one year, and in-person group intervention vs. individual intervention delivered via videophone. The investigators' primary hypothesis is that participants in the immediate DWW 2.0 intervention will increase their physical activity and reduce their caloric intake and body weight compared with those in the delayed intervention group (no intervention yet).


Eligibility Criteria:
Inclusion Criteria:

* Deaf men and women ages 21-70 years who use sign language and live in the Rochester Metropolitan Statistical Area (MSA),
* have a body mass index (BMI) of 25-45.
* Eligible subjects must also have permission to participate from a primary healthcare provider if: 1) self-reported diagnosis of a recent cardiovascular disease event (heart attack or stroke in past 6 months), 2) self-reported heart condition, chest pain, dizziness, or other reason not to participate in physical activity, 3) had weight loss surgery in the previous 2 years (self-reported), and 4) are pregnant (self-reported).
* Subjects must also be willing to follow a healthy dietary pattern and to abstain from using weight loss medications during the study, and be willing and able to attend either group or videophone sessions, and to participate in data collection requirements.

Exclusion Criteria:

* Exclusion criteria include: subjects without medical clearance who had 1) a cardiovascular disease event in the past six months, 2) or heart condition, chest pain, dizziness, or other reason not to participate in physical activity, 3) or weight loss surgery in the past two years, or 4) are pregnant. Participants with these conditions (as determined by the PAR-Q Physical Activity Readiness-Questionnaire and other questions administered during the initial study screening visit) must obtain medical clearance from their primary healthcare clinician (or maternity care clinician for pregnancy) to be eligible. Those who are unable or unwilling to provide written, informed consent, and inability to see and interact with computer-based questionnaires and educational interventions will be excluded.
The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position

The aim of this clinical investigation is to determine the effect of intraoperative ventilation on cerebral oxygen saturation in patients undergoing arthroscopic shoulder surgery in the beach chair position (BCP)

Recent developments in near-infrared spectroscopy technology now permit rapid assessment of cerebral oxygenation (SctO2) using non-invasive probes. A high incidence cerebral desaturation events (CDE-defined as a decrease in SctO2 values below 20% of baseline measures or absolute SctO2 values ≤ 55 for ≥ 15 seconds) have been observed in previous investigation of patients undergoing shoulder surgery in BCP with hyperventilation. The investigators hypothesize that the incidence of CDE will be reduced in patients ventilated at normocapnic levels (end-tidal carbon dioxide values (ETCO2) of 40-42 mm Hg) when compared to subjects hyperventilated (ETCO2 of 30-32 mm Hg) in the operating room. Patients undergoing shoulder surgery in the BCP will be randomized to a hypocapnic group (ETCO2 of 30-32 mm Hg) or a normocapnic group (ETCO2 of 40-42 mm Hg). Cerebral oxygenation will be measured continuously throughout the procedure to assess perioperative SctO2 values and the incidence of CDE. The investigators previously observed an association between CDE in the operating room and postoperative nausea and vomiting. Therefore, the effect of ventilatory pattern and intraoperative SctO2 on clinical recovery will also be determined.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for elective shoulder arthroscopy under general anesthesia in the BCP.

Exclusion Criteria:

* Exclusion criteria include 1) history of pre-existing cerebrovascular disease or orthostatic hypotension 2) age \< 18 years 3) American Society of Anesthesiologists Physical Status IV or V.
Beta-1 Adrenergic Inhibition to Reduce Cardiac Injury and Inflammation After Subarachnoid Hemorrhage (BADCATS)

To determine the effect of early metoprolol administration after non-traumatic subarachnoid hemorrhage (SAH).

To determine the effect of early metoprolol administration after non-traumatic subarachnoid hemorrhage (SAH) on the brain and cardiac tissue damage and inflammation, we will conduct a pilot randomized controlled trial comparing (1) sympathetic nervous system (SNS) activation, (2) cardiac rhythm abnormalities, (3) biomarkers of brain and cardiac tissue damage, and (4) and neutrophil activity in patients receiving metoprolol (n=10) or placebo (n=10) for the first 72-hours after SAH.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* Neuro-imaging confirmed non-traumatic subarachnoid hemorrhage

Exclusion Criteria:

* Traumatic cause of subarachnoid hemorrhage (e.g. fall, motor vehicle accident, other blunt trauma) as this is a different mechanism of hemorrhage.
* Other forms of traumatic or non-traumatic intracranial bleed including intracerebral hemorrhage (ICH), subdural hemorrhage, epidural hemorrhage
* Pregnancy (as the study medication, metoprolol, has FDA Pregnancy Category C rating)
* Unstable vital signs not amenable to beta-1 adrenergic receptor inhibitor (B1ARi) administration including:
* Systolic blood pressure \< 80 mmHg not stabilized on vasopressor medications
* Heart rate \< 50 bpm associated with hypotension
* Patients requiring vasopressor agents due to hypotension (SBP \<80 mmHg)
* Other vital sign exclusion at the discretion of the treatment team
* Previous history of severe heart failure (Stage C or D Heart Failure and/or NYHA Class III or IV)
* Patient or legally authorized representative unwilling to provide informed consent
Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Highly Emetogenic Chemotherapy (0869-801)(COMPLETED)

A multicenter trial to assess the safety and efficacy of an investigational drug in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with confirmed solid tumors who will be treated with a chemotherapy regimen that includes cisplatin. The study will evaluate the investigational drug for the treatment of CINV during the first cycle of treatment with cisplatin.


Eligibility Criteria:
Inclusion Criteria:

* Patient is greater than 18 years of age.
* Patient is scheduled to receive his/her first

course of cisplatin chemotherapy for a solid tumor.

* Patient has a prognosis (life expectancy) greater than or equal to 3 months.
Improving REsectability in Pancreatic NEoplasms (IRENE)

Evaluation of clinical response in terms of resectability of patients with locally advanced pancreatic cancer treated with neoadjuvant chemotherapy plus stereotactic body radiotherapy.

Aim of the study is to define the percentage of patients with down-staging and clinical response after having undergone stereotactic radiotherapy + chemotherapy with neoadjuvant intent for locally advanced pancreatic carcinoma or "borderline resectable" at the time of diagnosis.

The study evaluates the response to therapy in terms of resectability, of acute and delayed treatment-related toxicity, of overall survival and progression-free survival and also assesses patient's quality of life.

Eligibility Criteria:
Inclusion Criteria:

* histological diagnosis of locally advanced pancreatic carcinoma, not upfront surgically treated (according to NCCN resectability criteria), without distant metastases
* NCCN criteria resectability status
* patient's age, performance status, possible presence of comorbidity should also be considered to decide the optimal approach (upfront surgery versus neoadjuvant treatment).
* If the chemotherapy treatment induces the disease to a condition of resectability, the patient will undergo a surgical evaluation
* indication for radiotherapy treatment
* ECOG 0-2
* obtaining informed consent
* not pregnant or breastfeeding

Exclusion Criteria:

* ECOG\> 2
* presence of internal diseases for which radiotherapy is contraindicated, or diseases of the connective system, or gastric or duodenal ulcer in progress or acute diverticulitis, ulcerative colitis
* comorbidity which in the opinion of the referring physician may constitute a risk for participation in the study
* lack of availability for clinical-instrumental follow-up
* previous abdominal radiotherapy.
To Assess Safety, Tolerability and Pharmacokinetics of BI 416970 in Healthy Male Volunteers

To investigate the safety and tolerability of BI 416970 and to assess the pharmacokinetics (PK) of single rising doses of BI 416970. A further objective is to assess the influence of CYP2C9 phenotype on the PK of BI 416970.


Eligibility Criteria:
Inclusion criteria:

* Healthy males according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead electrocardiogram, and clinical laboratory
* Age 18 to 50 years (incl.)
* Body Mass Index 18.5 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
* Known genotype of CYP2C9 isoenzyme

Exclusion criteria:

* Any finding in the medical examination (including Blood Pressure, Pulse Rate or Electrocardiogram) is deviating from normal and judged as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside of ranges 90-140 mmHg, diastolic blood pressure outside of ranges 50-90 mmHg, or pulse rate outside the range of 50 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication
* Diseases of the central nervous system (such as epilepsy), other peripheral neurological disorders or psychiatric disorders
Cognitive Behaviour Therapy and Nicotine Replacement to Increase Tobacco Cessation

Background: Pharmacological strategies to improve smoking cessation have been largely studied. The efficacy of cognitive behavior therapy associated to nicotine replacement in tobacco cessation has not yet been demonstrated.

Objective: Evaluate if cognitive behavior therapy during six weeks associated to nicotine replacement for twelve weeks is able to contribute to tobacco cessation at the end of 52 weeks.

Methods: Multicentre, open-label, and pragmatic randomized controlled trial will include 334 patients. Analysis will follow intention-to-treat principle.

Patients older than 18 years old and who had smoked at least 5 cigarettes in the past year before randomization will be included.

All of them will receive nicotine replacement therapy with patches and gum. They will be randomized 1:1 ratio to attend or not cognitive behavior therapy once a week for the first six weeks of the treatment. Every two weeks all of the patients will be evaluated by a physician in order to access any adverse effects from the nicotine replacement.

All patients will have carbon monoxide levels accessed at baseline and after 6 weeks. Telephonic interview will be done at 16, 28, and 52 weeks to access the rates of tobacco cessation, relapses episodes and abstinence maintenance.


Eligibility Criteria:
Inclusion Criteria:

* Smokers (≥ 5 cigarettes/day during the previous year) who had not had a period of abstinence greater than 3 months before randomization
* Age ≥ 18 years \< 75 years;
* Capable of reading and understanding Portuguese;
* Willing to quit smoking.

Exclusion Criteria:

* Dementia;
* Alcoholism;
* Regular use of illicit drugs;
* Panic disorders;
* Psychosis;
* Current pregnancy;
* History of bipolar disturbance;
* Contraindication to nicotine patches;
* Prior use of bupropion and/or varenicline in the previous 12 months before randomization;
* Patients who refused to provide informed consent;
The Diagnostic Value of Acupoint Sensitization Based on Stable Angina Pectoris

Investigators adopt cross-sectional study design to carry out the exemplary research in the aspects of disease diagnosis.This study is designed to confirm the hypothesis "acupoint sensitization is associated with a severity of angina pectoris, which may contribute to the diagnosis of stable angina pectoris". After the eligible participants recruited in group, the coronary artery lesions will be evaluated through coronary angiography and the Canadian Cardiovascular Society(CCS) angina pectoris classification will also be evaluated at the same time. The degree of acupoint sensitization will be tested by the electronic Von Frey instrument by one professional acupuncturist with total 12 acupoints, including Shenmen,Yinxi, Shaohao,Jiquan,Neiguan, Ximen, Quze, Shanzhong, Juque, Jueyinyu, Xinyu, Duyu. Analysis were conducted to explore relationships between the degree of acupoint sensitization, the degree of coronary artery stenosis and CCS angina pectoris classification. Diagnostic value will be further analyzed in the final step.


Eligibility Criteria:
Inclusion Criteria:

* Patients meet the diagnostic criteria of ACC/AHA angina pectoris of coronary heart disease
* The frequency of angina attacks were greater or equal to twice a week over the previous 3 months
* Patients agree to do coronary angiography examination and sign the informed consent.

Exclusion Criteria:

* People with mental disabilities and intelligent obstacle
* Patients who can't accomplish the detection of acupoint sensitization
* Patients with allergic condition, especially the contrast media
* Patients with acute myocardial infarction, unstable angina, during arrhythmia and serious diseases which can affect the blood supply of myocardial
* Patients with skin or peripheral nerve paresthesia, pain or the detect area of skin ulcerate
* Pregnant or lactating women
* Patients who undergoing other clinical trials
Prognosis Factors of Cardiac Complications After Liver Transplantation

This is a prospective, multicenter, non-interventional, observational study of a cohort with a biological plasma and urine samples collection for the study of prognosis factors of cardiac complications after liver transplantation

Liver transplantation (LT) is the standard treatment for chronic or acute hepatic insufficiency with 87% of one-year survival. Cardiovascular complications are common after LT with an incidence at 6 months ranging between 25 and 50 %. These complications are associated with significant morbidity and represents the third cause of post LT mortality. Myocardial perfusion imaging or stress echocardiography, used for preoperative cardiovascular evaluation, are not enough efficient to predict the risk of post LT cardiovascular complications. However, to improve the prediction capacity of cardiovascular disease is fundamental in order to better select the candidates for LT or to develop preventive strategies. Such a strategy could reduce the morbidity and mortality from cardiovascular diseases after LT and improve the results of LT. Cardiovascular biomarkers such as troponin or natriuretic peptide are known to be predictive factors of postoperative cardiovascular complications in non cardiac surgery. The use of biomarkers in combination with conventional tests could improve the preoperative prediction of post LT cardiovascular complications.

Hypothesis: The preoperative biomarkers dosage could improve the prediction of cardiovascular complications occurring in the year after LT.

Eligibility Criteria:
Inclusion criteria:

- Patients older than 18 years, on list for LT because of chronic hepatic disease.

Non-inclusion criteria:

- emergency LT, patient under guardianship or trusteeship.

Secondary exclusion criteria:

* Patient out of list before liver transplant because of his death, his improvement, the existence of a contraindication
* Patient not presenting laboratory tests older than 1 year at the liver transplantaion.
* Patient included for over 2 years at the time of Liver transplantation.
Safety Study of Atomoxetine and Cerebrovascular Outcomes

Using a proprietary insurance health claims database, Eli Lilly and Company has contracted with an external party to conduct a retrospective cohort study of health claims for the time period from 1 January 2003 through 31 December 2006 (with follow-up of patients through 30 June 2007). This study will evaluate the potential association between atomoxetine and cerebrovascular events. In this study, the incidence of selected cerebrovascular outcomes as represented in health claims data among adult patients who initiate therapy with atomoxetine will be estimated. In particular the study will focus on cerebrovascular accident (CVA) and transient ischemic attack (TIA) as the outcomes of interest. The incidence for each outcome among atomoxetine initiators will then be compared to the incidence in a cohort of similar patients who initiate stimulant treatment and an age and gender-matched general population cohort. The atomoxetine and stimulant-initiating cohorts will be matched on a broad variety of variables, including age, gender, diagnoses, medication use, and healthcare utilization through the use of propensity score matching in order to minimize the influence of confounding by indication. The analysis will include the cohorts (atomoxetine and stimulant initiators) from a previous completed study with increased follow-up time (1 January 2003 through 30 June 2007) and accrue new atomoxetine and stimulant ADHD medication initiators over a 2 year period, so that the study will represent initiators between January 1, 2003 and December 31, 2006 with follow-up through June 30, 2007.


Eligibility Criteria:
Inclusion Criteria:

* patients 18 years or older
* received dispensing of one of the study medications during the time period of the study (January 1, 2003 - December 31, 2006)
* 6 months of continuous enrollment prior to first dispensing

Exclusion Criteria:

* presence of pre-existing arrhythmia and heart failure during the baseline period
Investigation of the Steady State Pharmacokinetics of Tacrolimus, Mycophenolate Mofetil and Fluvastatin After Renal Transplantation

Steady state pharmacokinetics of tacrolimus, mycophenolat mofetil and fluvastatin in renal transplant patients are investigated to look for potential interaction between these drugs.

All patient enrolled in this PKI-Study had no changes in the therapy before or because of the study. Only patients without changes more than 4 weeks were included


Eligibility Criteria:
Inclusion Criteria:

* renal transplant patients (18 - 65 years, inclusive)
* cadaver and living renal transplants(1. Ntx, 2. Ntx)
* Immunsuppression: Tacrolimus with or without Mycophenolat Mofetil und and fluvastatin Fluvastatin for a minimum of three months
* writen informt consent by the patient

Exclusion Criteria:

* contraindications for statins
* pregnancy or lactating
* elevated liver or muscle encymes (\> 2x up to normal values: AST, ALT, bilirubine, CPK)
Youth Health and Social Media

The purpose of this study is test the American Academy of Pediatrics (AAP) Family Media Use plan among teens and their parents through a randomized intervention and assess impact on outcomes including family media rules and health behavior outcomes.

For this study there will be three time points of data collection and participant contact by Qualtrics:

Time 1: Baseline

Participants (teen and parent dyads) will be randomized into one of two tracks:

Track A: Family Media Use Plan intervention Track B: Awareness intervention (delayed start intervention)

The track A group will complete a survey regarding technology rules, tech use, and health behaviors, as well as the Family Media Use Plan embedded into the survey. Track B group will only complete the baseline survey.

Time 2: Follow Up Survey: 4-6 weeks after baseline

Track A group will complete a follow-up survey similar to the baseline with additional follow-up questions around their use of the family media use plan.

The track B group will complete a similar survey and receive the Awareness Intervention, providing resources available regarding youth and media use .

Time 3: Follow Up Survey: 3-4 months after baseline

All participants will be asked to complete their corresponding tracks (track A or track B) survey again to understand use media use and health behaviors change over time.

Track A or B designated questions are labeled within each uploaded survey.

Eligibility Criteria:
Inclusion Criteria:

* English speaking and between the ages of 12 and 17
* Parents must be English speaking and have a child between the ages of 12 and 17

Exclusion Criteria:

* n/a
Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Substance Use

This study examines whether isolated doses of d-cycloserine enhance the efficacy of an exposure-based cognitive-behavioral treatment for chronic and treatment refractory substance dependence.

This is a placebo-controlled trial of the efficacy of 50mg d-cycloserine or matching pill placebo for enhancing the efficacy of CBT.

Eligibility Criteria:
Inclusion criteria:

The primary selection criteria include women and men between the ages of 18 and 65 who:

1. Meet DSM-IV criteria for opiate dependence,
2. Maintain a stable dose of methadone for two weeks prior to recruitment and:

   * fail to achieve "take-home" status for methadone dosing during at least the first four months of methadone treatment,
   * test positive on at least two toxicology screens for illicit drugs during the month prior to recruitment
   * have never achieved two consecutive toxicology screens free of illicit substances since entering the current treatment episode.
3. Meet study criteria for chronic stress:

   * unemployment criteria, and
   * affective disorder criteria.

Exclusion Criteria:

1. Patients with significantly unstable or uncontrolled medical illness which may interfere with participation in treatment (e.g., patients likely to require hospitalization during the study period).
2. Patients with a psychotic or organic mental disorder according to DSM-IV criteria.
3. Patients receiving medication affecting methadone metabolism (e.g. rifampin).
4. Patients with uncontrolled bipolar disorder as evidenced by meeting current criteria for mania or hypomania or meeting criteria for rapid cycling in the last year (as indicated by structured questioning of all patients meeting criteria for bipolar disorder).
5. Patients unable to complete the informed consent or unable to understand study procedures in the informed consent process.
6. Pregnancy or current alcohol use.