cyrilzakka/clinical-trials huggingface dataset:
Methoxyflurane and Fentanyl in LBNP

The study is a single-centre, placebo-controlled, crossover study on healthy volunteers aiming to explore non-inferiority of methoxyflurane and fentanyl compared to placebo on the tolerance to hypovolemia.

The study will explore the effects of fentanyl and methoxyflurane versus placebo (NaCl; saline) on the hemodynamic response to hypovolemia in healty volunteers. Hypovolemia will be induced in the "lower body negative pressure" model. XX healthy volunteers will be exposed to inhaled methoxyflurane, 3 ml or intravenous fentanyl, XX mg or placebo in a randomized order (cross-over) at least 3 days apart.

Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age.
* Must be below 65 years of age.
* Signed informed consent and expected cooperation for the study and follow up must be obtained and documented according to ICH GCP, and national/local regulations.

Exclusion Criteria:

* Any medical condition limiting physical excertional capacity or requiring regular medication (allergy and oral contraceptives excepted)
* Pregnancy
* History of syncope (syncope of presumed vasovagal nature with known precipitating factor excepted)
* Any known cardiac arrhythmia
* History of renal disease
* History of liver disease
* Previous substance abuse
* Allery or known serious side-effects to opioids or methoxyflurane
Rifaximin SSD in Dementia Trial

Using a new formulation of rifaximin, a non-absorbable antibiotic, to test if it can affect microbes in the gut of patients with dementia favorably.

Hypothesis: Rifaximin SSD therapy is safe and well tolerated in patients with AD and VaD with beneficial changes in systemic inflammation and systemic biomarkers of dementia due to improvement in microbiota function compared to placebo-related changes in a single-blind, placebo-controlled Phase 1b/2a trial .

Overall Objective: In a single blind placebo-controlled trial in patients with Alzheimer's or vascular dementia, to determine the effect of rifaximin SSD compared to placebo on gut microbial structure and function, cognitive and daily function, and caregiver burden.

Eligibility Criteria:
Inclusion Criteria:

* Probable Alzheimer's Disease (AD) or Vascular Dementia (VaD) mild or moderate based on Clinical Dementia Rating Scale.
* Males and Females Age ≥ 65 years
* Community living with availability of caregiver to accompany participant to study visits and to participate in the study.
* Able to consent or legal guardian who can consent (with participant assent).
* Legally authorized representative (LAR) and caregiver for the study is the same individual.
* Fluency (both participant and caregiver) in written and spoken English to participate in study visits.

Exclusion Criteria:

* Dementia not due to AD or VaD
* Clinically significant agitation or aggression (requiring treatment with antipsychotic medication)
* Delusions and/or hallucinations
* Severe psychopathology including major depression
* Unstable, severe, or poorly controlled medical conditions evident from physical examination or clinical history
* Visual and/or hearing disorder that prevents completion of neuropsychologic evaluations.
* Diarrhea
* Hypersensitivity to rifaximin, components of rifaximin,
* and any rifamycin antimicrobial agent
* Antibiotic use in the prior 6 months
* Taking medications that interact with Rifaximin. P-glycoprotein (P-gp) inhibitor treatment is permitted as long as the use of P-gp inhibitors is discussed with the investigator.
* History of alcohol and/or drug abuse
* Participation in another investigational drug trial in the last 30 days
Neutrophil Gelatinase Associated Lipocalin (NGAL) in Urine: Can This Prove to be a Biomarker for Acute Kidney Injury in Patients With Sepsis?

Patients with severe infection and sepsis are in high risk of hypo perfusion and therefore organ affection. Temporary or permanent kidney failure is a common complication in these patients. Today's golden standard for kidney failure detection is creatinine levels rising and / or oliguria. The investigators hypothesize that an even more sensitive biomarker; neutrophil gelatinase associated lipocalin(NGAL) in urine can predict kidney injury before creatinine levels rise. In recent studies NGAL in urine seem to be a sensitive biomarker in these patient to predict kidney injury, but the time factor for sampling optimally is not known. In this pilot study the investigators sample the urine at admission within the first hour of hospitalization to investigate if NGAL can be used as a predictor in an emergency setting.


Eligibility Criteria:
Inclusion Criteria:

* Severe sepsis
* Septic shock
* Patients must not be able to give consent

Exclusion Criteria:

* Underaged (18 years )
* known kidney injury
* Fully alert patients that can give consent
Post-POEM GERD in Patients Undergoing Conventional Versus Oblique Fibers Sparing Posterior Myotomy for Achalasia Cardia

In this study, we will evaluate the incidence of reflux esophagitis between two different techniques of posterior per-oral endoscopic myotomy (POEM) i.e. conventional POEM versus oblique/ sling fiber sparing POEM. This is a randomized trial where the patients with idiopathic achalasia will be randomized in two groups in 1:1 fashion into groups.

In this randomized trial, patients with idiopathic achalasia will undergo POEM using two techniques as follows. In the first technique, a conventional posterior POEM will be performed where the sling or oblique fibers will not be spared during POEM. Sling or oblique fibers will be recognized using the configuration of fibers below the gastroesophaeal junction and by identifying the border between the sling fibers and the circular fibers which is formed by the penetrating vessels. In the second group (Oblique fiber group), the sling fibers will be selectively spared and only the circular fibers will be spared.

The other steps of the POEM procedure will be the same as described in the standard technique of POEM. These include submucosal injection of saline mixed with indigo carmine dye, mucosal incision, submucosal tunneling using triangular knife in spray coagulation mode (Effect 2, Watts 50), myotomy extending upto 2-4 cm below the gastroesophageal junction and the closure of mucosal incision using endoclips.

Post POEM management: All the patients will be kept nil per oral for about 24-hours after the procedure. A timed barium swallow will be performed the next day and oral liquids will be started. A soft puried diet will be started from day 3 onwards.

Oral proton pump inhibitors (PPIs) equivalent to 40 mg of Pantoprazole per day will be prescribed to all the patients unless a contraindication exists.

Follow-up: The first evaluation will be performed at 2-months after POEM. During this evaluation, the following parameters will be recorded: symptom relief, reflux symptoms, and esophageal acid exposure. PPIs will be stopped for 1-2 weeks prior to the evaluation of GERD.

Subsequent evaluation will be at 6-months for reflux symptoms and symptoms of achalasia using Eckardt scores.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with type 1 and 2 achalasia with Eckardt score \>3 (0-12 scale achalasia).
2. Patients with age 18-75 years.
3. Patients who are treatment naïve or have a history of pneumatic balloon dilatation.
4. Patients who are willing and able to comply with the study procedures and provide written informed consent form to participate in the study

Exclusion Criteria:

1. Patients with type 3 achalasia cardia or any other esophageal motility disorder,
2. Patients who have undergone previous surgery of the esophagus or stomach,
3. Patients with active severe esophagitis,
4. Patients with large lower esophageal diverticula,
5. Patients with large ( \> 3cm ) hiatal hernia,
6. Patients with sigmoid oesophagus,
Study Evaluating Etanercept 25mg or 50mg Administered Subcutaneously to Healthy Chinese Male Subjects

The primary purpose of this study is to assess the pharmacokinetics of etanercept in healthy Chinese male subjects. Safety and tolerability data will also be obtained.


Eligibility Criteria:
1. Men, aged 18 to 45 years, of Chinese descent and living in China.
2. Body mass index in the range of 18.0 to 30.0 kg/meter squared and body weight equal to or greater than 50 kg.
3. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, chest x-ray, and 12-lead electrocardiogram (ECG).
4. Have a high probability for compliance with and completion of the study.
DART II - A Phase IV Study of 3 Antiretroviral Medicines in Combination, in HIV Patients Who Have Not Been Previously Treated With Antiretroviral Therapy

The purpose of this study is to evaluate whether a therapy with an all once daily regimen of stavudine extended release (d4T XR), lamivudine (3TC), and efavirenz (EFV) leads to improved outcomes, as measured by viral load, CD4 counts, adherence, safety, and tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older infected with HIV and weigh at least 40 kg.
* Plasma HIV RNA viral load of 1000 copies/mL or greater and CD4 count of 100 cells/mL or greater.
* Be willing to use two forms of contraception throughout study.
* No previous exposure to antiretroviral (ARV) drugs

Exclusion Criteria:

* Pregnancy or breastfeeding
* Physical or psychiatric disability
* Proven or suspected acute hepatitis within 30 days prior to study entry
* Active AIDS-defining opportunistic infection or disease
* History of acute or chronic pancreatitis
Tampostat for Management of Postpartum Hemorrhage

The purpose of the study is to evaluate the safety, feasibility and applicability of a new device 'Tampostat' in the management of primary postpartum hemorrhage and compare the efficacy of 'Tampostat' in terms of arresting primary PPH with that of the conventional condom catheter.

This will be a 2-year study having two parts. Part A will be a Proof of Concept (POC) study that will be conducted at the Obstetrical Ward of Shaheed Suhrawardi Medical College Hospital (ShSMCH) and Dhaka Medical College Hospital (DMCH). There is no sample size estimation of this POC study that will assess safety, feasibility and applicability of using Tampostat on 5 consenting women with PPH for each hospital. Part B of the study will be an open label, randomized clinical trial that will be conducted at the Obstetrical Ward of Dhaka Medical College Hospital (DMCH). In this part, 344 consenting women with primary PPH will be enrolled, and allocated to either Tampostat or the control intervention in equal numbers per randomization (172 patients in each arm). In both these parts, Tampostat will be used only when Active Management of Third Stage of Labour (AMTSL) has failed to prevent PPH within 24 hours after delivery. All the doctors involved in the provision of care and treatment to PPH patients will be trained on the WHO's standard of care; they will also receive training on appropriate use of the devices to be used in this trial. An expert committee constituted of OBGYN professionals, clinical trial specialists, and statisticians will oversee the technical management of patients, data collection and their procedures, and ethical issues in this trial.

Eligibility Criteria:
Inclusion Criteria:

1. Women who delivered their baby at the site hospital, or attended the site hospital with PPH that started within the last 24 hours.
2. Women with primary PPH have received AMTSL.
3. PPH is due to atonic uterus.
4. Provides written informed consent for enrolment in the study.

Exclusion Criteria:

1. Primary PPH caused by retained placenta or ruptured uterus.
2. Women who delivered before 28 weeks of gestation.
3. Women not willing to participate in the study.
Time Restricted Eating for Weight Loss Maintenance

The aim of this pilot feasibility and acceptability, randomized clinical trial will be to examine the effects of two-time restricted eating (TRE) interventions on weight loss maintenance (WLM). This study will be conducted in 40 individuals with non-surgical weight loss of ≥5% initial body weight recruited from the NYU Langone Health Weight Management Program and NY-MOVE! Weight Management Clinic at the Manhattan VA. Measurements will occur at baseline, 4 and 12 weeks. Participants will be randomized with equal allocation to 2 groups: (1) TRE6 or (2) TRE10. The TRE6 will restrict their eating window to 6 hours per day and the TRE10 to 10 hours per day.


Eligibility Criteria:
Inclusion Criteria:

* ≥5% non-surgical weight loss from NYULH-WMP and NY-MOVE! Endocrinology Weight Management Clinic in the last 3 months
* BMI between 20.5 - 45 m/kg2
* between the ages 25 to 65 years old
* own a smartphone or willing to use a smartphone if provided for self-monitoring
* Eating window \>12 h per day
* \<150 mins/wk of physical activity
* log at least 2 meals into the smartphone app on ≥5 days

Exclusion Criteria:

* \<25 years or \>65 years of age
* Body weight in excess of 400lbs (181.4kg)
* pregnant, trying to get pregnant or breastfeeding
* previous or planned bariatric surgery
* previous or current history of eating disorder
* ongoing participation in another weight-management research study
* continued participation in a weight loss program other than the proposed study
* currently on appetite suppressants
* currently following intermittent fasting or skipping meals
* eating window \<11h 59min/day
* perform overnight shift work more than once a week
* work that includes travel across one or more time zones
* currently on anti-obesity medications (AOMs) such as, GLP-1 analogues (exenatide, tirzepatide, semaglutide, liraglutide) and pancreatic lipase inhibitors (Orlistat/Xenical and Alli)
* prescribed medications expected to result in weight loss such as Orlistat, Naltrexone, Bupropion, Lorcaserin, Phentermine, Topiramate, or Liraglutide, and who are unwilling to delay treatment with these medications for the next 3 months
* unable or unwilling to provide informed consent
* unable to participate meaningfully in the intervention (e.g., uncorrected sight and hearing impairment)
* unwilling to accept randomization assignment
* unable to log at least 2 meals into the smartphone app on ≥5 d during the screening period
* have type 1 or other conditions that would preclude restricted eating windows
* have type 2 diabetes with a HbA1c \>7.0% on medications except for metformin alone
* narcolepsy
* active cancer
* organ dysfunction
* current steroid use
* daytime sleepiness with the Epworth Sleepiness Scale \>10
* severe insomnia with a score ≥15 on the Insomnia Severity Index
* \>2.5 kg additional weight loss during run-in phase (weight regain is not an exclusion criteria)
The Effect of Resistance Exercise on Inflammation in Young and Older Adults

Healthy young and older adults will complete two trials in a randomized crossover counter-balanced order, including resistance exercise and sedentary control. During each trial, blood samples will be collected.

The investigators hypothesized that an acute bout of resistance exercise exert different inflammation responses in young and older adults.


Eligibility Criteria:
Inclusion Criteria:

* Age: 20-80
* Healthy male
* Without experience of resistance training

Exclusion Criteria:

* No acute or chronic musculoskeletal symptoms
* Smoking
* Alcohol or drug abuse
* Fail to conduct resistance exercise
Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating adults with newly diagnosed primary malignant glioblastoma multiforme.

OBJECTIVES:

* Determine the antitumor activity of temozolomide in adults with newly diagnosed glioblastoma multiforme.
* Define the relationship between tumor O6-alkylguanine-DNA alkyltransferase activity and tumor response in these patients.
* Define the relationship between tumor DNA mismatch repair activity and tumor response to temozolomide.

OUTLINE: Patients receive temozolomide orally once daily on days 1-5. Treatment courses are repeated every 28 days. In the absence of disease progression and toxicity, patients receive up to 4 courses of treatment prior to radiation therapy. After radiation therapy, patients demonstrating partial or complete response may receive an additional 12 courses of treatment.

Patients are followed every 8-12 weeks for 2 years.

PROJECTED ACCRUAL: This study will accrue 50 patients.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven, newly diagnosed, supratentorial malignant glioblastoma multiforme not requiring immediate radiation therapy
* At least 1 bidimensionally measurable lesion

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 70-100%

Life expectancy:

* Greater than 12 weeks

Hematopoietic:

* Absolute neutrophil count at least 1500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL

Hepatic:

* Bilirubin less than 1.5 times upper limit of normal (ULN)
* SGOT and SGPT less than 2.5 times ULN
* Alkaline phosphatase less than 2 times ULN

Renal:

* BUN less than 1.5 times ULN
* Creatinine less than 1.5 times ULN

Other:

* Must be neurologically stable
* No systemic disease
* No acute infection requiring intravenous antibiotics
* No frequent vomiting
* No other medical condition that would interfere with oral medication intake such as partial bowel obstruction
* No prior or concurrent malignancies except:

  * Surgically cured carcinoma in situ of the cervix
  * Basal or squamous cell carcinoma of the skin
* HIV negative
* No AIDS-related illness
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior biologic therapy
* No concurrent biologic therapy (growth factors or erythropoietin)

Chemotherapy:

* No prior chemotherapy
* No other concurrent chemotherapy

Endocrine therapy:

* Concurrent steroid allowed (must be on stable dose for at least 1 week prior to study)

Radiotherapy:

* No prior radiation therapy
* No prior interstitial brachytherapy
* No prior radiosurgery to the brain
* Not requiring immediate radiation therapy
* No concurrent radiotherapy

Surgery:

* Recovered from any effects of prior surgery
* At least 2 weeks since prior surgical resection

Other:

* No other concurrent investigational drugs
Strategies to Promote Skin Health

The purpose of the intended proposed research is to investigate and determine best strategies for preventing skin cancer for emerging adults. To answer this question, the investigators intended to pilot a randomized control trial with three arms: 1) Facial Morphing, 2) Mindfulness, and 3) Treatment as usual. The population from which the sample was drawn from was undergraduate psychology students from a large public university in Southern California, who report recent indoor/outdoor tanning, and intentions for future tanning.

Indoor and outdoor tanning are two of the most common risk factors for developing skin cancer. Predictors of indoor and outdoor tanning including negative body image and negative affect. Thus, to subsequently prevent skin cancer, interventions should focus on appearance concerns and negative affect. To date, limited brief efficacious skin cancer preventions exist. One potential program (APRIL AGE) a facial morphing software program, has recently been evaluated as a potential prevention program of skin cancer. However, limited data exists on the long term benefits of this program. Additionally, brief mindfulness programs have been found to be efficacious in preventing other health risk behaviors (e.g., smoking, negative affect, eating behaviors). To the investigators' knowledge, these brief mindfulness interventions have yet to be applied in skin cancer prevention. Thus, the investigators sought to compare the relative efficacy of the facial morphing intervention and the mindfulness intervention vs. control condition (treatment as usual). It was hypothesized that both facial morphing and mindfulness would lead to reductions in tanning behavior compared to the TAU condition. The investigators also tested contrasts between the facial morphing and mindfulness conditions, however, no directional hypotheses could be generated, due to the dearth of prior data on these interventions in skin cancer prevention.

Eligibility Criteria:
Inclusion Criteria:

* 1) aged 18 years old or older
* 2) enrolled as a student at the University
* 3) engaged in either indoor or outdoor tanning in the last 30 days
* 4) intended to tan (indoor or outdoor) in the last 30 days
* 5) English speaking

Exclusion Criteria:

* Failure to meet any of the above mentioned inclusion criteria
Efficacy and Safety Study of HZT-501 in Subjects Requiring Nonsteroidal Anti-Inflammatory Drug (NSAID) Treatment

The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.

HZT-501 is a combination product including ibuprofen and the acid reducing agent famotidine. The study is designed to determine whether the combination product reduces the rate of ulcer development in subjects who require long-term daily use of ibuprofen.

Subjects will be assigned randomly, in approximately a 2:1 ratio, to treatment with either HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) or ibuprofen (800 mg) three times daily for a 24 week treatment period or until they develop either an endoscopically-diagnosed upper gastrointestinal ulcer and/or prohibitive toxicity. Subjects will visit the study center for Screening and at Weeks 4, 8, 16, and 24. Physical exams will be performed, and clinical laboratory measurements made, at selected times during the study. Endoscopic exams will be performed during Screening and at Weeks 8, 16, and 24. Subjects will be contacted four weeks following study completion.

Study with completed results acquired from Horizon in 2024.

Eligibility Criteria:
Inclusion Criteria:

* Expected to require daily administration of an NSAID for at least the coming six months for conditions such as osteoarthritis, rheumatoid arthritis, chronic low back pain, chronic regional pain syndrome, and chronic soft tissue pain.
* Did not use a NSAID within the 30 days prior to study entry

Exclusion Criteria:

* History of erosive esophagitis
* History of any of the following serious gastrointestinal complications:

  * perforation of ulcers,
  * gastric outlet obstruction due to ulcers, or
  * gastrointestinal bleeding.
* Active cardiac, renal, and/or hepatic disease
* Current Helicobacter pylori (H. pylori) infection
* Use of an acid suppressant agent, misoprostol, or more than 325 mg/day of aspirin within the 14 days prior to study entry.
* Uncontrolled diabetes
* Uncontrolled hypertension
* Positive pregnancy test at screening
* Positive test at Screening for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
* Currently participating, or participation within 30 days prior to study entry, in an investigational drug study

Please note that there are other additional criteria. The study center will determine if patients meet all of the criteria.
Assessment of Change in Atherosclerotic Plaque by Serial CCTA

Assessment of Change in AtheROSclerotic Plaque by Serial CCTA (ACROSS) is designed as a prospective observational study which aim is to demonstrate the effect of statins on coronary atherosclerosis, assessed by quantitative analysis of CCTA.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent clinically indicated CCTA (index CCTA)
* Mild to moderate stenosis (25-69%) on CCTA
* ≥1 clinical risk factors (Smoking, HTN, HDL\<40, Premature FHx, M ≥45, F ≥55) for CAD

Exclusion Criteria:

* Acute coronary syndrome (unstable angina or MI)
* Positive (not equivocal) stress test
* Contraindications to statin