cyrilzakka/clinical-trials huggingface dataset:
Second Young Adult Naturalistic Alcohol Study

This study involves completion of questionnaires, computer-based cognitive tasks and an alcohol drinking session. Participation in this study consists of an initial, in-person screening appointment, 4 brief daily appointments at the research office, an alcohol drinking session at a local bar and a follow-up appointment 1-3 days after the alcohol drinking session.

Participants who are found to be eligible in the screening phase will then complete a daily appointment for 4 days out of a 5-day period (i.e., there will be 1 day out of the 5 on which they will not attend an appointment). Each appointment will last 20 minutes, on average and consist of a questionnaire and computer-based cognitive task. On the day of the fourth appointment, participants will complete an alcohol drinking session. The alcohol drinking session begins at 4pm and lasts until at least midnight.

Participants in this study will be young adults between the ages of 21-25, who regularly drink alcohol and are not currently seeking treatment for alcohol use. Seventy-two participants will complete this study.


Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 21-25.
* Be able to read English and complete study evaluations.
* Drink alcohol on a regular basis

Exclusion Criteria:

No participant may:

* Be seeking treatment for alcohol or other addictive behaviors or have been in inpatient or intensive outpatient treatment within the past 12 months.
* Provide two positive breath alcohol concentration (BAC) readings (i.e., \> 0.00%) at any of the following times: in-person screening, a pre-session screening, or at the outset of an alcohol self-administration session. After participants blow their first positive BAC, they will be allowed to reschedule and participate at another time, however if they blow a second positive BAC, they will be excluded from this study and offered referrals for alcohol treatment.
* Have positive urine screen results at the in-person screening or pre-session screening on the day of an alcohol self-administration session for opiates, cocaine, phencyclidine, amphetamines, methamphetamine, barbiturates, methadone or benzodiazepines.
* A woman who is pregnant, nursing, or refuses to use a reliable method of birth control.
* Fail to perform at a normative level at screening on any of the four cognitive and psychomotor tasks administered in this study. Participants must perform within two standard deviations of the mean from the samples in relevant prior studies
* Perform computer tasks initially administered at baseline in either a random or inordinately slow fashion
* A body mass index lower than 18.5 or greater than 35.
Study to Compare and Assess the Safety and Pharmacokinetic Characteristics After Oral Administration of Fimasartan (BR-A-657∙K) in Healthy Elderly and Young Male Volunteers

The purpose of this study is to compare and assess the safety and pharmacokinetic characteristics after oral administration of fimasartan (BR-A-657∙K) in healthy elderly and young male volunteers.

Fimasartan (BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models.

Phase I study, Fimasartan (BR-A-657-K) 20 mg \~ 480 mg single dosing with healthy subjects, demonstrated that the Fimasartan (BR-A-657-K) was very safe and well tolerated. Another phase I study, Fimasartan (BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that Fimasartan (BR-A-657-K) was safe and tolerable though one temporal adverse event was observed in high dose.

A open-labeled, single-dosing, parallel Clinical Study to Evaluate pharmacokinetic characteristics after oral administration of fimasartan in healthy elderly and young male volunteers.

22 male healthy volunteers were enrolled during 2 months.

In part A, 240 mg of fimasartan per day was taken once by younger male healthy volunteers in day 1. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours after administration.

In part B, 240 mg of hydrochlorothiazide per day was taken once by elderly male healthy volunteers in day 1. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours after administration.

Eligibility Criteria:
Inclusion Criteria:

* age

  * young: 19-45 years
  * elderly: more than 65 years
* sex: male
* body weight: greater than 55 kg

Exclusion Criteria:

* patients with contraindication to angiotensin II receptor antagonist.
* patients with a history of liver, renal, gastrointestinal, hematological or cardiac diseases
* patients with history or diseases which might affect absorption of the drug
* patients with HIV, type B or C hepatitis
* smokers of 20 or more cigarettes per day
The Effects of Continuous Positive Airway Pressure on Overlap Syndrome

1. The first objective of this study is to determine the differences between, while the airway obstruction severity is the same, and the acute continuous positive airway pressure (CPAP) effect on chronic obstructive pulmonary disease (COPD) patients with overlap syndrome compared with COPD patients without in terms of sleep quality, autonomic nerve activity, biologic markers of systemic inflammatory, and exercise performance.
2. The second objective of this study is to evaluate the subacute (3 months treatment) CPAP effect on COPD patients with overlap syndrome in terms of pulmonary hemodynamic and right heart function, We will also determine the subacute effect of CPAP on sleep and life quality, autonomic nerve activity, biologic markers of systemic inflammatory, as well as exercise performance.
3. The last objective of this study is to evaluate the long term (12 months treatment) CPAP effect on COPD patients with overlap syndrome. The un-scheduled clinic or emergency department visiting, hospitalization, or mortality will be recorded to see if there is significant treatment effect in terms of reducing morbidity and mortality. The long term CPAP effect on sleep and life quality, autonomic nerve activity, biologic markers of systemic inflammatory, exercise performance, as well as pulmonary hemodynamic and right heart function will be re-evaluation.

COPD patients will be disturbed by season 12 months follow up is better than 18 months

Eligibility Criteria:
Inclusion Criteria:

* chronic stable COPD
* FEV1/FVC \< 70%
* No response to beta-agonist
* without acute exacerbation within2 months

Exclusion Criteria:

* Chronic respiratory failure (PaO2\<60 mmHg, PaCO2\>50 mmHg)
* Clinical evidence of congestive heart failure
* Facial defect and all the other condition that can't tolerate nasal mask
* Malignancy
Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip on Obese Parturients

Pregnant women, with a Body Mass Index (BMI) greater than 30 kg/m2, who receive epidural analgesia/anesthesia for childbirth will have epidural catheter placement per our standard procedure, which includes using the gravity flow technique to confirm that the tip (aperture) of the epidural needle is indeed located within the epidural space. The study procedure will be to use a cold stimulus (ice) to assess the subjects for hypesthesia the dermatomes of the lower abdomen between 10 and 30 minutes after the epidural catheter is inserted. Hypesthesia to cold will be taken a sign of successful lumbar epidural block.

The purpose of this study is to quantify the reliability of the gravity flow technique to accurately validate the position of the epidural needle tip when performing lumbar epidural analgesia/anesthesia for childbirth (vaginal and cesarean delivery) in women with a BMI greater than 30 kg/m2.

Eligibility Criteria:
Inclusion Criteria:

* Patients requesting epidural analgesia/anesthesia for childbirth
* American Society of Anesthesiologists (ASA) physical status I to III
* Ability to speak and read English to fully comprehend the consent process
* BMI greater than 30 kg/m2

Exclusion Criteria:

* Combined spinal-epidural anesthesia
* Coagulopathy
* History of lumbar spine surgery
* Allergy or contraindication to any of the study medications
* Contraindication to epidural analgesia
* ASA physical status \>III
* BMI less than 30 kg/m2
MIDCAB (Mid-Calf Block) for Foot Surgery

MIDCAB is defined as a group of ultrasound guided distal nerve blocks at the level of the individual branches. It is similar to an Ultrasound Guided (USG) Ankle block but the probe is placed higher on the calf covering all and any surgery of the foot and ankle, providing prolonged analgesia since we are blocking the individual nerves and preserving the proximal motor function.

This study is determining the potential therapeutic effect of MIDCAB during the hospital stay and recovery period in patients undergoing foot/ankle surgeries that require spinal anesthetic and peripheral nerve blocks. A total of 20 patients at HSS will participate to see if MIDCAB is not only effective at providing analgesia (pain relief) but to see if it allows allows patients to maintain motor function (movement) of the foot and ankle unlike the current popliteal block which is done above the knee and prevents patients from moving their foot.

During the course of the study we will also be looking at patients numeric pain scores with movement and at rest along with post-operative nausea and vomiting, the presence of numbness and it patients can move their foot. Along with all of these, the study will also look at the amount of opioid pain medications taken by patients along with medication-related side effects. As a result, the study will be used to determine if MIDCAB provides analgesia for patients undergoing foot/ankle surgery while allowing them to maintain movement of the foot. This pilot study will also be used to gather preliminary data that will allow us to perform a power analysis for a subsequent randomized clinical control trial that would compare the MIDCAB block to the popliteal block.


Eligibility Criteria:
Inclusion Criteria:

* Planned use of regional anesthesia
* Ability to follow the major components of the study protocol
* Planned foot or angle surgery

Exclusion Criteria:

* Patients younger than 18 years old and older than 80 years old
* Patients intending to receive general anesthesia
* Contra-indication to nerve blocks or spinal anesthesia
* Patients with an ASA status of IV or higher
* Chronic opioid use (taking opioids for longer than 3 months)
* Patients with prior foot or ankle surgery
* Patients with type 2 diabetes
A Questionnaire for Endoscopic Prediction Improvement of Gastrointestinal Cancer

Despite improvements in a range of chemo, radio and surgical therapies, the overall survival at 5 years from gastrointestinal cancer remains poor. Endoscopic early diagnosis is a key strategy to improve survival but the detection rate of early cancer varies among different countries. Risk factor questionnaire result is easy to be obtained and may be of great help for improving the detection rate. The aim of this research is to validate a risk factor questionnaire to help predict gastrointestinal cancer therefore allowing earlier diagnosis and higher detection rate.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged more than 18 years with or without GI symptoms attending for endoscopy.

Exclusion Criteria:

* Patients unable to cooperated the endoscopy or unable to complete it. People with endoscopy contraindications are naturally excluded.
Exercise,Metabolic Syndrome and Weight Regain (Echocardiography Substudy)

We plan to test the hypothesis that patients with metabolic syndrome will have impaired left ventricular diastolic parameters. These parameters will be measured before and after a stress test at the end of a 3 month period of exercise training and a 10% weight loss.

Patients must have 2 of the 5 criteria for metabolic syndrome and be able to exercise in a monitored setting for 45 min 5 times a week.

Eligibility Criteria:
Inclusion Criteria:

* 2 of 5 criteria for metabolic syndrome
* Ability to exercise for 45 min 5 days a week

Exclusion Criteria:

* No diabetes
* Established coronary disease
Botulinum Toxin to Improve Cosmesis of Primary Cleft Lip Repair

Objective: To determine if the use of botulinum toxin during primary cleft lip repair improves the cosmetic appearance of the cleft lip scar


Eligibility Criteria:
Inclusion Criteria:

* complete unilateral cleft lip with or without cleft palate
* planned for a primary cleft lip repair

Exclusion Criteria:

-bilateral cleft lip
Repetitive Transcranial Magnetic Stimulation to Reduce Heroin Cravings

The purpose of this research study is to test the effect of repetitive transcranial magnetic stimulation (rTMS) on opioid cravings among adult patients with Opioid Use Disorder.

This study will use rTMS, a neuromagnetic and non-invasive treatment, to reduce opioid cravings in individuals who are diagnosed with opioid use disorder. Repetitive transcranial magnetic stimulation is currently used for the treatment of Major Depressive Disorder and Obsessive Compulsive Disorder in clinical practice. This proposed study will employ a randomized, single-blind, experimental design. Participants will be randomly assigned to two groups using a computer-based randomization program: treatment and sham-control groups.

Eligibility Criteria:
Inclusion Criteria:

* Adult aged 18-64, used heroin in the past 30 days;
* has a history of heroin use for at least one year;
* meets the clinical criteria for Opioid Use Disorder (only heroin use will be considered to meet this criteria);
* meets the clinician clearance using the rTMS Patient Screening Form.

Exclusion Criteria:

* do not currently take and medications for a substance use disorder such as methadone, buprenorphine, naltrexone, acamprosate, disulfiram;
* do not have a psychotic disorder;
* do not have a diagnosis of another substance use disorder;
* do not have a history of seizures or other neurological disorders including organic brain disease; epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery;
* do not have a personal history of head trauma that resulted in a loss of consciousness for more than 5 minutes and retrograde amnesia for more than 30 minutes;
* do not have a presence of non-fixed metal in body 30 cm to treatment coil.
* have not taken any medication for a substance use disorder within the last 72 hours before the first rTMS treatment;
* are not pregnant or think you may be pregnant.
Post-Marketing Study Using PROLIEVE® for the Treatment of Benign Prostatic Hyperplasia (BPH)

The primary objective of the post-marketing study is to collect safety and effectiveness data for 5 years on subjects treated with Prolieve®. The collection of 5-year safety information will be used to evaluate the occurrence of any long-term side effects from the treatment. The collection of long-term effectiveness data on subjects treated with Prolieve® will provide information on the long-term effects of treatment and time to re- treatment (any treatment initiated for BPH since Prolieve'" treatment, including a second treatment with Prolieve").


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with symptomatic BPH.
* Peak Urine flow rate \<12 ml/sec on voided volume of \>125mL.
* AUA symptom score value ≥9(9).
* Signed informed consent.

Exclusion Criteria:

* Subjects whose pain response has been significantly decreased by any means (because the subject's ability to detect pain is a treatment safety mechanism).
* Subject with a history of any illness or surgery that might confound the results of the study " or impede the successful completion of trial"
* Subject with a history of any illness for which the Prolieve® treatment may pose additional risk to the subject.
* Subject with the confirmed or suspected malignancy of the prostate
* Subject with the confirmed or suspected bladder cancer
* PSA \>10 ng/mL
* Subject with previous treatment to the prostate (e.g., surgery, balloon dilation, stents, laser, TUNA, or Indigo prostatectomy) and/or non-metallic urogenital implants (e.g., penile prostheses, artificial urinary sphincters)
* Subject with prostate weighing \<20 or \>80g.
* Subject with previous pelvic irradiation or radial pelvic surgery
* Subject having large, obstructive middle lobe
* Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease.
* Subject with urethral stricture and/or bladder stones
* Active urinary tract infection.
* Subject with neurogenic bladder and/or sphincter abnormalities due to Parkinson's, multiple sclerosis, cerebrovascular accident (CVA), diabetes, or other disease process.
* Residual bladder volume \>250 mL measured by ultrasound.
* Compromised renal function (i.e., serum creatinine levels above 1.8 mg/dL).
* Cardiac pacemaker or metallic implants or staples, etc. in the pelvic or femoral area.
* Concomitant medicating of the following:

  1. Bladder antispasmodics (Ditropan or Detrol) within one week of treatment, unless there is documented evidence that the subject has been on the same drug dose for at least three months with a stable voiding pattern. The drug dose will not be altered or discontinued for the entrance into or throughout the study.
  2. 5-alpha reductase inhibitors and gonadotropin releasing hormonal analog.
  3. Alpha blockers, antidepressants, androgens, within one week of treatment.
* Subject interested in future fertility/fathering children.
* Subject with full urinary retention.
* Subject with bleeding disorder or liver dysfunction associated with a bleeding disorder.
* Subject with prostatic urethra length of \<1.2 cm or \>5.5 cm.
Hemiarch vs Extended Arch in Type 1 Aortic Dissection

HEADSTART is a prospective, open-label, non-blinded, multicenter, randomized controlled trial that compares a composite of mortality and re-intervention in patients undergoing hemiarch and extended arch repair for acute DeBakey type 1 aortic dissection. Eligible patients will be randomized to one or the other surgical strategy and clinical and imaging outcome data will be collected over a 3 year follow up period.

DeBakey Type 1 aortic dissections continue to have high operative mortality and morbidity and there is equipoise in available literature with regards to the best operative strategy and patient selection criteria. Hemiarch repair is current standard of care in most centers but extended arch repair is gaining popularity aiming to address early post-operative malperfusion and improve long term aortic remodeling.

HEADSTART is a randomized controlled prospective trial of patients presenting to participating institutes with acute DeBakey 1 aortic dissection. Patients will be enrolled and randomized into one of two groups - 'hemiarch repair' and 'extended arch repair'. Pre-operative, early post-operative and long term follow clinical and CT imaging data will be collated on a centralized database and at a core lab respectively.

Eligibility Criteria:
Inclusion Criteria

1. Emergent surgical repair of Acute DeBakey Type 1 aortic dissection
2. Age \>18 years and \<70 years
3. Operating surgeon believes that both surgeries could be safe and effective

Exclusion Criteria

1. Hemodynamic instability/shock defined as systolic BP \< 90 mm Hg
2. Previous cardiac surgery with sternotomy or thoracic endograft placement
3. Aortic arch diameter \> 6cm in which a concomitant arch replacement is judged necessary
4. Procedures deemed to be "salvage operations" where the patient is unlikely to survive hospital discharge.
5. GCS \< 8 for more than 6 hours
6. History of cirrhosis.
7. History of chronic renal failure (baseline eGFR \< 50)
8. Metastatic malignancy
9. Pregnancy
Effect of Sago-based Product on Glycaemic and Lipid Control in Diabetes

This will be a parallel, randomised, double-blind, controlled trial. Upon successful screening, subjects will be randomised to either intervention arm or control arm in a ratio of 1:1. The subjects will consume either a drink containing 25g of Sarawak sago starch (intervention) or 25g of corn starch (control) in approximately 200mL of water, two times a day, before lunch and dinner for 12 weeks, in addition to a standardised dietary counselling for diabetes given by the hospital dietitian at baseline. The study endpoints will be evaluated after 12 weeks of starch consumption.

SAGODM trial is a parallel, randomised, double-blind, controlled trial on the effect of consuming sago starch for 12 weeks on glycaemic and lipid control in patients with type 2 diabetes mellitus. Diabetic patients who had HbA1C between 6.5% and 8.5% and had no change in the antidiabetic treatment for the past two months (primary inclusion criteria) were invited to participate in the trial. They were randomised to either the intervention arm or control arm in a ratio of 1:1. The subjects will consume either a drink containing 25g of Sarawak sago starch (intervention) or 25g of corn starch (control) in approximately 200mL of water, two times a day, before lunch and dinner for 12 weeks. They will receive standardised dietary counselling for diabetes given by the hospital dietitian at baseline. They will also be asked to record their dietary intake for three consecutive days every month. Blood samples will be taken at baseline and the last visit (post-12 weeks). The study endpoints will be evaluated after 12 weeks of starch consumption.

Eligibility Criteria:
Inclusion Criteria:

1. 18 - 70 years old
2. Individual diagnosed with type 2 diabetes for at least three months
3. Not on any antidiabetic medications or on lifestyle modification or taking a stable dose of oral hypoglycaemic agents, with no change of dose and regime for the past eight weeks
4. Has HbA1C values of 6.5 - 8.5% within 28 days before commencing the study
5. Able to complete the clinical study, and
6. Able to provide written informed consent

Exclusion Criteria:

1. History of allergy to sago starch or corn starch
2. History of allergy to any other ingredients in the study foods
3. Clinically significant, active and acute cardiovascular disease
4. Clinically significant, stage 4 - 5 (estimated glomerular filtration rate \<30mL/min/1.73m2), chronic kidney failure
5. Clinically significant chronic liver disease or infection
6. Any malignancies
7. Regular use of hormone medications, anti-inflammatory medication, steroids, or other medications that might interfere with outcome measure
8. On a prescribed therapeutic diet
9. Taking part in weight loss programme
10. Clinically significant abnormal laboratory investigations
11. Other medical conditions or reasons, in the opinion of the Investigator or Research Physician, that make one unsuitable to join the study
12. Concurrent participation in other clinical studies involving intervention or treatment towards obesity, diabetes or impaired glucose
13. Pregnant or lactating mothers