cyrilzakka/clinical-trials huggingface dataset:
Effect of LAPS-Exendin on Body Weight in Obese Population

The purpose of this study is to determine the optimal dose and regimen of HM11260C, in combination with a hypocaloric diet, to reduce weight in obese subjects who are otherwise considered in stable health.

Phase 2 study

Eligibility Criteria:
1. Inclusion Criteria:

   * Age: 18 years to 65 years
   * Genders: male and female
   * healthy obese population
   * non-diabetes
   * stable body weight for at least 3 months prior to screening
2. Exclusion Criteria

   * Pregnant or nursing (lactating) women
   * Drug-induced obesity
   * Diabetes mellitus (type 1, 2, and other)
   * Previous surgical treatment for obesity
   * Any known history of severe gastrointestinal (GI) disease or intolerance
   * Known history of pancreatitis with presence of raised serum amylase and lipase
   * History of suicide attempts or recent history (within 2 years prior to screening) of major depression, anxiety, or other psychiatric disease requiring treatment with prescription medication including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitor s (SNRIs), antipsychotics, and lithium.
The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study

This study is designed to evaluate the effect of pacing on post-MI patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or above, or of legal age to give informed consent specific to state and national law
* Willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol
* Patient has had a clinically documented anterior myocardial infarction which occurred within the last 14 days
* Measured peak CK \> 2000 mU/mL within 72 hours of MI.
* QRS duration \< 120 ms measured by 12-lead ECG at any time after most recent MI

Exclusion Criteria:

* Patient has atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) or persistent (i.e., can be terminated with medical intervention, but does not terminate spontaneously) at time of enrollment
* Patient is in cardiogenic shock defined by systolic blood pressure \< 90 mmHg and on pressor/inotrope medications at time of potential enrollment
* Patient has 2 or 3 degree heart block at time of potential enrollment
* Patient has undergone or is scheduled for a coronary artery bypass graft procedure, 30 days before or 30 days after date of potential enrollment
* Patient has a known life expectancy of less than 6 months due to non cardiac causes
* Patient has marked renal dysfunction defined as Creatinine \> 2.5 mg/dL at time of enrollment
* Patient enrolled in any concurrent study that may confound the results of the study
* Patient is in class IV heart failure
* Patient is on the heart transplant list
* Patient already has an implanted pacemaker, ICD, or CRT device
* Patient is pregnant or plans to be pregnant during the course of the study
* Both
Evaluating The Acceptability and Uptake of Pre-Exposure Prophylaxis (PrEP) for Adolescent Women in The Deep South

This project is designed to 1) develop a PrEP implementation plan for a general adolescent clinic. Investigators will develop a replicable implementation plan for providing PrEP to adolescents in a primary care setting; and 2) Determine the acceptability and preliminary effectiveness of a telehealth intervention to promote adherence in adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Females between 15 to 21 years old
* Established patients at the Adolescent Health Center
* HIV negative

Exclusion Criteria:

* HIV positive patients
* patients weighing less than 35kg
* patients with creatinine clearance \<60 ml/min
* patients with documented osteopenia or osteoporosis or history of pathologic fractures
* patients with previous allergic reactions to either emtricitabine or tenofovir
* patients who are on post-exposure prophylaxis for HIV (they can become eligible after completion of therapy)
* patients with hepatic impairment
* For patients who become pregnant, they may be able to continue on PrEP after a discussion with their obstetrics/gynecology (OB/GYN) provider.
Comparison of Efficacy Of Probiotic Toothpaste and Chlorhexidine Mouthwash To Reduce S.Mutans

Orthodontic appliance causes increase in plaque accumulation, especially around brackets, wires and attachments. Advances in orthodontics in recent time have led to improved quality of appliance and treatment procedures ultimately resulting in improvised standard of patient care.

These bacteria metabolize different kind of carbohydrates accumulated around orthodontic appliances and create acidic environment in the oral cavity leading to enamel demineralization around the brackets and white spot lesions.

This study was carried out to evaluate and compare the efficacy of probiotic toothpaste and chlorhexidine mouthwash in patients undergoing orthodontic treatment with individuals who are not using them.

INTRODUCTION - When the basic oral hygiene is poor, orthodontic appliances create areas where plaque gets accumulated, especially around brackets, bands, wires, and other attachments; this facilitates the development of white spot lesions. Probiotics act by competitively inhibiting the pathogenic bacteria because they have greater adhesion to the tissues while Chlorhexidine is often used as an active ingredient in mouthwash designed to reduce dental plaque around orthodontic appliances. AIM \& OBJECTIVE - The objectives of the study is to evaluate and compare the effects of the topical application of probiotic toothpaste and chlorhexidine mouthwash on the Streptococcus Mutans levels in the plaque of orthodontic patients hence improving the oral micro-flora of oral cavity by competitive inhibition of Streptococcus Mutans in plaque present around brackets.

MATERIAL \& METHOD - The study consists of thirty randomly selected orthodontic patients undergoing fixed appliance treatment. The patients were divided into three groups - Control Group (Group 1), Probiotic Toothpaste Group (Group 2) \& Chlorhexidine Mouthwash Group (Group 3). Samples were collected at two times interval: before the study began (Phase 1) and after thirty days (Phase 2).

Eligibility Criteria:
Inclusion Criteria:

* Orthodontic Treatment With The Straight Wire Appliance (MBT, 0.022-in Slot; 3M Unitek, Monro- Via, Calif), Permanent Dentition (Excluding Third Molars)
* Good General Health (No Significant Medical History Or Drug Use During The Last Month)
* No Anti-inflammatory Or Antibiotic Medications Taken In The Month Before The Study
* No Chewing Gum Or, Mouthwash Used In The Last Week And During The Study
* Habit Of Brushing Twice Daily With Fluoride Toothpaste

Exclusion Criteria:

-Patient with poor periodontal condition Patient with known medical condition e.g. Subacute bacterial, endocarditis , diabetes, valvular disease ,anaemia etc
Amiodarone and N-Acetylcysteine or Amiodarone Alone for Preventing Atrial Fibrillation After Thoracic Surgery

This trial will be comparing the combination of amiodarone and NAC (n=122) to amiodarone alone and NAC matched placebo (n=122) to determine the rates with which sustained (lasting \>30 seconds) or clinically significant POAF is reduced in high risk patients within 7 days after major thoracic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years old scheduled for elective thoracic surgery (segmentectomy, lobectomy or bi-lobectomy, pneumonectomy or esophagectomy) and meeting one of the four following risk criteria:

  * 1. Female \& BNP ≥ 25pg/ml (no age limit)
  * 2. Male gender \<75 \& BNP ≥ 25pg/ml
  * 3. Male- age ≥75 (No BNP limit)
  * 4. History of prior AF
* Patients in sinus rhythm.
* Patients with stable respiratory status (no respiratory distress).
* Patients capable of providing written, informed consent.

Exclusion Criteria:

* Patients scheduled for extrapleural pneumonectomy.
* Hemodynamically unstable patients (not in cardiogenic shock or having an acute MI).
* Patients with 2nd or 3rd degree atrioventricular (AV) block.
* Patients with hypersensitivity to amiodarone or NAC.
* Patients already taking class Ic or III antiarrhythmic drugs.
* Hepatic insufficiency (≤2 times the upper normal limit of transaminase levels).
* Renal insufficiency (creatinine ≥2.0 mg/dl).
* Known pregnancy.
Comparing a Patient Self-Assessment Software to Treatment as Usual in Opioid Prescriber and Patient Opioid Outcomes

The Care Continuity Program (CCP), a product of Sure Med Compliance, is a novel, online patient self-assessment used by prescribers of opioids to better identify patient risk factors and therapy benefit. This tool is completed by the patient, outside of the office, using an internet enabled device and follows a compliance driven protocol developed by analyzing case law against physicians in mis-prescribing opioid cases. Results, in the form of a date and time stamped legal report, are instantly transmitted to the prescriber's electronic health records, mitigating the prescriber's civil and criminal risk. A brief of findings is displayed within the software through a dashboard and on the summary page of the report. This software offering includes a mobile and standard web-based application. The objective of the proposed research is to validate the protocols and delivery system of the CCP by measuring patient outcomes, prescriber confidence, and completeness of documentation in the patient chart in primary care and pain management settings, pre and post implementation of the CCP.


Eligibility Criteria:
Inclusion Criteria:

* Prescribed an opioid at a participating clinic
* Completed a baseline CCP assessment
* Report functional impairment due to chronic pain
* Report at least a 4 out of 10 on pain intensity
* Have no psychiatric, mental, or physical limitation that precludes participation in the trial

Exclusion Criteria:

* Current cancer diagnosis
* Palliative or end of life care
Application of Perioperative Remote Ischemic Conditioning in Patients Undergoing Hepatectomy

Our primary aim is to investigate whether perioperative remote ischemic conditioning (PRIC) as an adjunctive treatment can improve postoperative recovery in patients undergoing hepatectomy as an adjunct to standard treatment.

Remote Ischemic Conditioning (RIC) can be applied as repeated short-lasting ischemia in a distant tissue that results in protection against subsequent long-lasting ischemic injury in the target organ. This protection can be applied prior to or during a prolonged ischemic event as remote ischemic pre-conditioning (RIPreC) and per-conditioning (RIPerC), respectively, or immediate after reperfusion as remote ischemic post-conditioning (RIPostC).

RIC is a non-pharmacologic and non-invasive treatment without noticeable discomfort, commonly achieved by inflation of a blood pressure cuff to induce 5-minute cycles of limb ischemia alternating with 5 minutes of reperfusion. However, whether perioperative remote ischemic conditioning (PRIC) can improve postoperative recovery in patients undergoing hepatectomy has never been investigated in a randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing hepatectomy under general anesthesia
* American Society of Anesthesiology (ASA) grade of II \~ III
* Male and female patients, age 25 to 75 years
* New York Heart Association (NYHA) grade of I \~ III

Exclusion Criteria:

* Patients with limb deformity or peripheral vascular disease affecting upper limb function
* Patients with a medical history of nervous system, immune system and mental illness
* Patients who have received hepatectomy in the past, have important organ diseases or have undergone surgical treatment recently
* Patients who have recently used anti-inflammatory analgesics, anticoagulants, hormone drugs, immunosuppressants, and ATP-sensitive K-channel blockers (KATP)
* Preoperative severe renal insufficiency (serum creatinine \> 442 umol/L, with or without serum potassium \> 6.5 mmol/L, or the clinician-recognized need for renal replacement therapy), liver insufficiency (Child-Pugh grade C)
* Patients and/or their family members refuse to participate in the program
How Accurate INFANIB is Among Hospitalized Preterm Infants

Reliability of infant neurological international battery (INFANIB) among hospitalized preterm infants will be checked. This study will mainly focus on test-retest reliability.

Background: NICU is a specialised intensive care unit that treats and cares for premature or critically ill newborn babies. A special category of high-risk babies consists of premature infants. Their motor growth differs from that of healthy full-term infants and their occurrence of motor disorders is greater. The outcome of neuromotor disorders can be substantially changed by treatments during the first year of life. So in order to detect these neuromotor disorder there must be a reliable screening tool present. Hence, in this study we will check reliability of INFANIB.

Purpose: Reliability of INFANIB among hospitalized preterm infants. Methodology: It will be an observational study and will be carried out in Neonatal Intensive Care Unit (NICU). The study will recruit preterm infants that are stable and are present without any respiratory assistive devices.

INFANIB screening tool will be performed on these infants. It has 20 items that measure the state of the infant for body tone and posture, primitive reflexes and French angles in the supine, prone, sitting, standing and suspended position upto 18 months. But we will take only preterm infants so only 14 items will be assessed and infants will be scored accordingly. The main focus will be on test- retest reliability.

Discussion: A similar research has been carried out in Iran and China, that established that reliability of INFANIB is excellent. Another research was carried out in India that stated INFANIB's reliability to be low. So this study is required to be carried out in India to know the actual results.

Eligibility Criteria:
Inclusion Criteria:

1. Preterm neonates.
2. Stable neonates.

Exclusion Criteria:

1. Unstable neonates.
2. Neonates on respiratory assistive devices.
Functional GI Disease Registry

The goal of this study is to establish a prospective observational cohort of individuals with functional GI disorders (functional constipation, irritable bowel syndrome, chronic nausea, functional diarrhea, and functional dyspepsia, as well as a subset of these individuals starting neuromodulation for their functional GI disorder) and collect clinical information and specimens. This information will be used in order to establish a patient registry with detailed clinical data and a specimen repository for future research as well as to specifically identify environmental, genetic, physiological, and psycho-social factors associated with functional GI disorders.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Rome IV criteria for a functional GI disorder

Exclusion Criteria:

* Acute illness
* Known bleeding disorder
* Awaiting transplantation
* Known diagnosis of Inflammatory Bowel Disease
* Use of antibiotics in last 2 months
Diagnostic Benefits of HyperQTM vs. Conventional ECG Stress Test. Comparison of HyperQ vs. Stress ECG in Women Before Angiography

The purpose of this study is to verify the efficiency of the HyperQ technology compared with standard ECG analysis in detecting exercise induced ischemia in women who are referred to coronary angiography.

Cardiovascular disease (CVD) is the leading cause of mortality in women. In fact, CVD is responsible for a third of all deaths of women worldwide and half of all deaths of women over 50 years of age in developing countries. Historically, women have been underrepresented in clinical trials. The lack of good trial evidence concerning sex-specific outcomes has led to assumptions about CVD treatment in women, which in turn may have resulted in inadequate diagnoses and suboptimal management, greatly affecting outcomes. This knowledge gap may also explain why cardiovascular health in women is not improving as fast as that of men. Over the last decades, mortality rates in men have steadily declined, while those in women remained stable.

The treadmill exercise test is the classic initial investigation for the diagnosis of coronary artery disease (CAD), and significant ST depression on the ECG is the commonly used indicator of a positive test. Compared with men, in women it is known that ST depression is less likely to be associated with CAD. False positive rates of treadmill exercise testing have been reported to be as high as 67%, while positive predictive value is around 48-50%.

Coronary angiography is one of the most frequently performed procedures in women; however, non-obstructive (ie, \<50% stenosis) CAD is frequently reported. Additionally, approximately 30% of women undergoing PTCA because of a positive exercise test are found to have normal coronary arteries. A successful outcome in the current study will significantly improve non-invasive diagnosis of CAD in women and may reduce the number of unnecessary invasive procedures performed.

Eligibility Criteria:
Inclusion Criteria:

* A woman who was referred to angiography.
* A woman who is able (i.e. no contraindications) to perform an exercise stress test
* A woman who signed an informed consent form.

Exclusion Criteria:

* Contraindications for an exercise test
* Wolff-Parkinson-White (pre-excitation) syndrome.
* Left Bundle branch block, Complete Right bundle branch block or QRS duration \> 120 ms, change in QRS morphology during exercise
* Atrial Fibrillation or significant ventricular arrhythmia
* Treatment with Digoxin
* Pacemaker
* Having taken beta blockers within 24 hours before the exercise test
* Pregnancy or suspected pregnancy
Breastfeeding Education and Support Trial for Obese Women (BESTOW)

The primary objective of this study is to evaluate the efficacy of a specialized exclusive breastfeeding education and support program targeting obese, pregnant, low-income women in Hartford, CT. Specifically, the investigators will evaluate the impact of the intervention on exclusive and partial breastfeeding rates at birth, 1, 3 and 6 months pp. Secondary aims of this study are: a) to characterize postpartum weight loss patterns and blood pressure values of obese women, by study group; and b) to evaluate potential differences in infant morbidity (diarrhea, otitis media and rehospitalization), by study group.


Eligibility Criteria:
Inclusion Criteria:

* obese (prepregnant BMI 27.0 or greater)
* pregnant women delivering at Hartford Hospital
* no more than 34 weeks gestation
* considering breastfeeding this child
* low income (\<185% Federal poverty level)
* planning to remain in the greater Hartford area for 6 months postpartum
* must have access to a telephone for follow-up interviews
* delivery of a healthy, term, singleton

Exclusion Criteria:

* HIV positive or having other conditions which interfere with exclusive breastfeeding
* Infant admitted to the Neonatal Intensive Care Unit
Role of Metabolites in Nicotine Dependence (1) - 1

The purpose of this study is to determine the effects of cotinine with or without a transdermal nicotine replacement on tobacco withdrawal symptoms.

The purpose of this study was to determine the effects of a metabolite of nicotine, cotinine, on tobacco withdrawal symptoms. Cotinine has been shown to have psychoactive effects that are similar as well as different from those of nicotine, however, little research has been conducted examining the role cotinine plays in nicotine addiction. This study compared the effects of cotinine with the nicotine patch, and a combination thereof on tobacco withdrawal symptoms. The results showed that cotinine antagonizes the beneficial effects of the nicotine patch in reducing withdrawal symptoms.

Eligibility Criteria:
Inclusion Criteria:

Male or female subjects, aged 21-45 yrs inclusive, with a smoking history of at least 1 pack of cigarettes daily for at least 1 year. Subject must be in good health as verified by medical history, screening exam, and screening laboratory tests. Subject must provide written informed consent to participate in the study and be motivated to stop smoking for a short term.

Exclusion Criteria:

History of myocardial infarction, angina pectoris, sustained or episodic cardiac arrhythmias, symptomatic peripheral vascular disease, peptic ulcer disease or any other medical condition which the physician or investigator deems inappropriate for participation, insulin-dependent diabetes; pregnant or lactating or not using adequate birth control methods; requirement of any form of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history; chronic use of systemic steroids or antihistamines; skin sensitivity which would preclude use of a transdermal system; abuse of alcohol or any other recreational or prescription drug; use of any other tobacco products, including smokeless tobacco and nicotine products; previous use of transdermal nicotine system; inability to fulfill all scheduled visits and examination procedures throughout the study period.
Format of Patient Education for Different Sociodemographic Groups

Questionnaire study to investigate the effect of individual characteristics such as age, sex, ethnicity, educational level and socioeconomic status on the preferred format of patient education delivery, for patients with diabetes and/or cardiovascular disease

An anonymous questionnaire will be used to collect basic demographic data for patients with the conditions of interest, in addition to information about their preferences for the format in which they receive patient education information. This data will be statistically analysed to address the primary and secondary outcomes of the study:

1. To investigate the effect of individual characteristics such as age, sex, ethnicity, educational level and socioeconomic status on the preferred format of patient education delivery.
2. To identify reasons for preference of patient education delivery, and whether these are associated with sociodemographic factors.
3. To assess the distribution of sociodemographic factors from participants who prefer online education, in order to identify whether preference for online education is associated with particular sociodemographic factors.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or over.
* Diagnosed with cardiovascular disease (defined as heart disease, peripheral vascular disease or stroke) or Type 2 diabetes
* Has not already completed the questionnaire
* Able and willing to complete questionnaire

Exclusion Criteria:

* Participant unable or unwilling to complete questionnaire
* Under the age of 18
* Not diagnosed with any of the conditions of interest
* Participant has already completed the questionnaire
* Unable to communicate (assisted or otherwise) in written English