cyrilzakka/clinical-trials huggingface dataset:
Effects of Sitagliptin on Gastric Emptying in Healthy Subjects

The purpose of this study is to determine the effects of the drug, sitagliptin, on the rate at which the stomach empties, and the release of gut hormones and blood glucose concentrations, after a mashed potato meal in healthy subjects. Sitagliptin has been shown to reduce the blood glucose (sugar) response to a meal and this may potentially be due to slowing of stomach emptying. This is particularly relevant to people who have diabetes, in whom normalization of elevated blood glucose levels is important to maintain health.

The purpose of this study is to evaluate the effect of sitagliptin on gastric emptying, intragastric meal distribution, postprandial glycemia and insulinemia in healthy subjects. Glucagon-like peptide-1 (GLP-1) inhibits gastric emptying, thereby slowing the delivery of nutrients, and their absorption, across the small intestine. The rate of entry of carbohydrate into the small intestine is especially important in patients with diabetes mellitus. Sitagliptin is an orally administered inhibitor of dipeptidyl-peptidase-IV (DPP-IV), the enzyme responsible for the degradation of GLP-1. It is hypothesized that sitagliptin will increase the GLP-1 response to, and thereby slow gastric emptying and diminish the glycemic response to, a carbohydrate-containing meal.

Fifteen healthy subjects (male and female) will be studied. Each subject will be studied on two occasions following treatment for 2 days with sitagliptin (100mg once daily) or matching placebo in a randomized, double blind, crossover design. Measurements of gastric emptying, intragastric meal distribution, blood glucose concentrations, gut hormones and appetite will be measured for 4 hours following ingestion of a mashed potato meal.

Eligibility Criteria:
Inclusion Criteria:

* Male or female (females must be using an appropriate contraceptive method)
* 18 - 45 years
* Body mass index (BMI) 19 - 25 kg/m2.

Exclusion criteria:

* Subjects with gastrointestinal disease, history of gastrointestinal surgery and/or significant gastrointestinal symptoms
* Subjects taking medication known to influence gastrointestinal function
* Alcohol intake \> 20 g per day
* Smoking \> 10 cigarettes per day
* Pregnant and/or lactating females
* Calculated creatinine clearance \< 60 ml/min
* Exposure to ionising radiation for research purposes in the previous 12 months.
AXS-05 Phase II Trial on Smoking Behavior

This research study is designed with the purpose of evaluating a new drug, combination Dextromethorphan-Bupropion (AXS-05), for its effects on smoking behavior.

This study aims to investigate the potential efficacy of a combination of two FDA-approved agents, sustained release (SR) Bupropion (BUP) and immediate release (IR) Dextromethorphan (DXM), for the purpose of smoking cessation treatment. DXM, a widely used over-the-counter cough suppressant, is a nicotine receptor antagonist. In fact, studies by Duke's Center for Smoking Cessation (CSC) have shown that administration of DXM leads to a decrease in self-administration of nicotine in nicotine-dependent rats. DXM, however, has not been studied in humans. DXM, when taken alone, is not expected to be useful for treating nicotine dependence in humans given DXM rapidly metabolizes in humans via CYP2D6. As a result, therapeutic concentrations needed to bind to nicotine receptors are not obtained. Therapeutic concentrations of DXM are required, therefore, to allow DXM to bind to nicotine receptors and act as a nicotine antagonist. In order to attain therapeutic concentrations of DXM a metabolism inhibitor must be introduced. BUP is a well-known FDA approved smoking cessation medication that has been shown to inhibit the metabolism of DXM. When BUP is co-administered with DXM to healthy volunteers, a significant increase in DXM plasma levels is observed.

Currently, Axsome Therapeutics Inc. (Axsome) is developing and testing an oral fixed-dose combination of IR DXM with SR BUP to achieve therapeutic concentrations of DXM. This investigational drug has been named AXS-05. Axsome has found AXS-05 to be generally safe and well-tolerated in three Phase 1 studies. The adverse event profile of AXS-05 was similar to that of BUP alone.

Given the distinct mechanisms by which BUP and DXM interact, it is hoped that combining DXM and BUP will prove more efficacious than either drug administered alone for the purpose of tobacco use treatment in humans.

Eligibility Criteria:
Key Inclusion Criteria:

1. Age 18 years or above
2. Daily smoker using 10 or more cigarettes per day
3. Willing to be smoke-free for 7 days
4. Is able to provide written informed consent (in English) to participate in the study and able to understand the procedures and study requirements.
5. Is willing to voluntarily sign and date an informed consent form that is approved by an institutional review board before the conduct of any study procedure.

Key Exclusion Criteria:

1. Current use of a smoking cessation medication (e.g. nicotine replacement, Varenicline, bupropion)
2. Current use of tobacco product other than cigarettes (e.g. e-cigarettes, smokeless tobacco)
3. Not pregnant or breastfeeding
4. Contraindication to the use of bupropion.
5. Additional criteria may apply.
A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers

The primary purpose of this study is to evaluate the safety and tolerability of Lpathomab in healthy volunteers. Additional endpoints include characterization of the pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity profiles of a single IV dose of Lpathomab in healthy volunteers.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy male or female subject ≥ 18 years old between 50 and 145 kg
* Laboratory values and ECG during Screening period within normal range or evaluated as not clinically significant (NCS)
* Female subjects must be not of child-bearing potential or using double-barrier method of contraception
* Male subjects must use double-barrier contraception during the study period
* Subject is able to read, understand, and sign the informed consent form (ICF) and HIPAA release

Key Exclusion Criteria:

* Subjects with diabetes mellitus (glycated hemoglobin \[HbA1c\]≥6.5%) or pre-diabetes mellitus (HbA1c between 5.7 and 6.4%).
* Male subjects with corrected Q-T interval (QTc)\> 450 msec or a QRS interval\>120 msec and female subjects with QTc\> 470 or a QRS interval\>120 msec.
* Subject's blood pressure (BP) during screening period exceeds 140/90 mm Hg
* Subject is positive for HIV, hep B and/or hep C at screening
* Subject has significant psychiatric co-morbidity including but not limited to major depression-severe, bipolar disorder or schizophrenia spectrum disorder, history of suicide attempt, or active suicidal ideation in 6 months prior to screen.
* Subject has any significant or advanced systemic illness, unstable or severe medical condition(s) or end stage disease that could put them at risk during the study, interfere with outcome measures, or affect compliance with the protocol procedures and requirements.
* Subject has history of cancer stability/remission for less than 5 years, with the exception of non-metastatic basal and/or squamous cell carcinomas of the skin and cervical cancer in situ.
Post Marketing Surveillance (PMS) Study for Velaglucerase Alfa (VPRIV) in India

The main aim of this study is to measure the safety and to find out the effects of VPRIV in participants with Gaucher disease using both retrospective and prospective data when used in the post-marketing setting and to collect genetic mutation data from participants with Gaucher disease.

This study is about collecting data available in the participant's medical record as well as data from each participant's ongoing treatment. No study medicines will be provided to participants in this study.

When the participants start the study, they will visit the study clinic close to approximately 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Participants with type 1 Gaucher disease prescribed VPRIV according to the investigator's judgment and current Indian Prescribing information (PI) are eligible for this study.
* Participants or legally authorized representative must provide written informed consent to participate.

Exclusion Criteria:

- Participants will be excluded from this study if the participant met any of the contraindications included in the current Indian PI for VPRIV.
Vibro-Acoustography Imaging in Diagnosing Breast Masses in Women With a Breast Mass or Breast Cancer

RATIONALE: New diagnostic procedures, such as vibro-acoustography imaging, may be an effective method of diagnosing breast cancer.

PURPOSE: This clinical trial is studying how well vibro-acoustography imaging works in diagnosing breast masses in women with a breast mass or breast cancer.

OBJECTIVES:

* To study in vivo detection of breast masses by vibro-acoustography (VA) imaging.
* To evaluate the performance of VA imaging in differentiating between benign and malignant breast masses identified as BI-RADS 4 or 5.

OUTLINE: Patients undergo clinical mammography of the breast, followed by vibro-acoustography (VA) imaging using ultrasonography over 90 minutes. Patients may also undergo further imaging using clinical ultrasonography.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Suspiciuos breast lesions identified as BI-RADS 4 or 5 and 3
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Female
* Menopausal status not specified
* Not pregnant
* No condition that does not allow proper use of study imaging devices

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Study Of RV-39 In Patients Who Also Have Asthma

This study will last up to 9 weeks. Subjects will visit the clinic up to 14 times. Certain clinic visits will include a physical examination, lung function tests, inflammatory cell analysis from nasal secretions and/or sputum, and blood draws. Subjects will inhale an FDA approved virus through their nose which is known to cause the common cold. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study are approved for the age group under study.


Eligibility Criteria:
Inclusion Criteria:

* Have asthma for at least 3 months prior to the study.
* Have been using an allowed pre-study asthma therapy for at least 3 months prior to study.
* Demonstrate airway hyperresponsiveness following inhalation of bronchoconstrictor.
* Have a positive allergic status antibody test.

Exclusion Criteria:

* Have a history of life-threatening asthma.
* Been hospitalized for asthma within the 24 months prior to the study.
* Have certain conditions that would make study participation unsafe.
* The study doctor will evaluate other inclusion and exclusion criteria.
Atherosclerosis in Rheumatoid Arthritis

The purpose of this study is to investigate the link between rheumatoid arthritis and cardiovascular disease by studying inflammation, joint disease, cholesterol abnormalities, and endothelial function.

In the general population, individuals with elevated inflammatory markers (e.g. C-reactive protein, CRP) have increased cardiovascular disease. Patients with RA have chronic elevations in CRP and other inflammatory markers that are usually higher than the levels associated with increased cardiovascular risk in the general population. Indeed, RA patients have accelerated disease of their blood vessels, and increased cardiovascular death not explained by traditional cardiac risk factors but associated with chronic inflammation. However, the mechanisms by which inflammation leads to cardiovascular disease are not well characterized in RA. Moreover, current treatment strategies of RA largely target joint symptoms rather than inflammation, potentially leaving patients at increased risk for cardiovascular disease. Studies of markers that increase the risk of heart disease in the full spectrum of RA are missing. We hypothesize that inflammatory markers will be more strongly associated with abnormalities in blood vessels in RA patients than any clinical measure of disease activity. This hypothesis will be tested with a cross-sectional study of patients in the UCSF RA cohort. Aim 1 will characterize abnormal blood vessel changes across the spectrum of RA disease activity, specifically measuring ultrasound of the upper arm artery, markers of oxidative stress, and abnormalities in cholesterol proteins. Aim 2 will identify factors associated with these changes across the spectrum of RA disease activity, specifically focusing on the association between inflammatory markers, cholesterol, and blood vessel abnormalities.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA by ACR criteria
* Age 18-80
* Enrolled in UCSF RA cohort already

Exclusion Criteria:

* Diabetes (on meds or in medical history)
* Pregnant or Lactating
* Renal failure (Creatinine \> 2mg/dL or on dialysis)
* History of MI or CAD
* History of ischemic CVA
* Symptomatic PVD
* Current uncontrolled hypertension (blood pressure \> 160/100mmHg)
* Daily prednisone \> 10mg daily
* Current smoker
* New BP med within 3 months
* New statin within 3 months
* Change in RA meds: new or increase in prednisone within 1 month, new TNF inhibitor within 2 months, titration of methotrexate, leflunomide or sulfasalazine within 3 months.
Effects of Aerobic and Resistance Training on Accumulation of Old, Modified Proteins in Young and Older Adults

Muscle proteins accumulate damage during aging and leads to the loss of muscle mass and function in older people. Exercise can increase the making of new proteins and removal of older proteins, but it is not known if the effect changes with aging or type of exercise. The investigators will determine the ability for endurance, resistance, or a combination of exercise training to remove older-damaged proteins and make newer-functional muscle proteins in groups of younger and older people. The investigators will particularly study protein that are involved with energy production (mitochondrial proteins) and force production (contractile proteins).

Hypothesis 1: Older people will have greater accumulation of damaged proteins than younger people.

Hypothesis 2: Aerobic exercise will decrease the accumulation of damaged forms of contractile and mitochondrial proteins in younger and older people.

Hypothesis 3: Resistance exercise will decrease the accumulation of damaged forms of contractile proteins in younger and older people.

The loss of muscle mass and function with age leads to high social and economic costs. Lifestyle interventions that can help maintain muscle mass and function can be beneficial to improve health and decrease the costs associated with loss of independence in the elderly. Muscle proteins accumulate damage during aging, which is suggested to lead to loss of function. The biological processes that remove damaged proteins and synthesis new proteins appear to be decreased with aging. Exercise is known to increase the processes that remove older and synthesis newer muscle proteins and may be an effect lifestyle intervention to improve muscle quality and function. Additionally, specific types of proteins appear to decay with age including contractile and mitochondrial proteins. Different types of exercise training can increase the making of specific proteins. The investigators will examine the ability for aerobic and resistance training to increase the quality of mitochondrial and contractile proteins between younger and older people.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* 18 to 30 years or 65 to 80 years old
* Male and female

Exclusion Criteria:

* Regular exercise program
* Smoking
* Metabolic disease (diabetes, cardiovascular disease, cancer, thyroid disorders)
* Pregnancy
* Inability to exercise
* Overweight or obesity
* Drugs known to impair metabolic function (statin, beta-blocker, anti-inflammatory)
* Allergies to lidocaine
Estrogen Supplementation Mode in HRT-FET Cycle: a RCT

A systematic review and meta-analysis concluded that there is insufficient evidence to recommend one particular protocol for HRT with regard to pregnancy rates after frozen embryo transfer, and no comparison of estrogen dose or route of administration was included in the review\[7\]. It is worth highlighting that the authors did not find any literature discussing the effect of estrogen dose and route of administration for HRT on reproductive outcomes. In 2016, a retrospective cohort study concluded that there is no difference in live birth rates between a constant dose versus an increasing dose of estrogen in oocyte donation cycles with oral or transdermal supplementation\[6\]. In order to provide good evidence about pattern of estrogen supplementation in HRT-FET, a randomized controlled study is urgently needed.

The present randomized controlled study aims to compare between a constant estrogen dose protocol and a step-wise increasing estrogen dose protocol on the live birth rate of HRT-FET cycles.

The objective is to compare between a constant estrogen dose protocol and a step-wise increasing estrogen dose protocol on live birth rate of HRT-FET cycles.

This is a multicenter randomized controlled trial. Women undergoing HRT-FET will be recruited and randomized to use a constant estrogen dose protocol and a step-wise increasing estrogen dose protocol.

Participation in the study is totally voluntary. The subjects can withdraw from the study at any time and they will still receive standard medical care.

Women being scheduled for HRT-FET will be assessed for eligibility. Eligible women will be recruited in the study and each woman will only be included in the study once.

Informed written consent will be obtained prior to recruitment. The baseline characteristics will be collected. Transvaginal ultrasound will be done to measure the endometrial thickness on the day of progesterone supplementation. Embryo transfer will be performed 3 days or 5 days after progesterone use, depending on replacement of cleaving stage embryos or blastocysts respectively.

Eligibility Criteria:
Inclusion Criteria:

* Women aged \<42 years at the time of HRT-FET
* Replacing 1-2 early cleavage embryos or blastocysts after thawing.

Exclusion Criteria:

* Preimplantation genetic testing(PGT)
* Use of donor oocytes
* Hydrosalpinx shown on pelvic scanning and not surgically treated such as tubal ligation or resection
* Severe uterine adhesion
* The endometrial thickness cannot reach 8mm in previous fresh cycles or HRT -FET cycles
Quality of Life and Pain Outcomes Following Video-Assisted Thoracic Surgery (VATS) Anatomic Lung Resection Versus Thoracotomy and Anatomic Lung Resection

The purpose of this study is to see if different types of surgery for lung cancer have different effects on quality of life and pain. What we learn from this study may help us find new ways to improve the quality of life of lung cancer patients who have surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed or suspected clinical stage I non small cell lung cancer (including carcinoid tumors) based on standard staging (CT, PET, ± mediastinoscopy).
* Patients offered a VATS anatomic lung resection or a standard, posterolateral thoracotomy and anatomic lung resection at MSKCC.
* Patients cannot have had prior therapy, including surgery for the current lesion, systemic chemotherapy or external beam radiotherapy.
* KPS ≥ 70.
* Synchronous primaries within one lobe.

Exclusion Criteria:

* Patients who have already undergone the planned operation.
* Patients who cannot tolerate segmentectomy or lobectomy.
* Patients with locally advanced or metastatic disease found either preoperatively or at the time of operation.
* Patients who are non- English speaking
* Patients with multi-focal disease
* Patients with con-current cancers
* Patients with benign disease.
* Patients who are unwilling or unable to return to Memorial Sloan-Kettering Cancer Center for postoperative follow-up for the first year following their operation.
Exercise Intervention Using mHealth in Patients With Post-Acute COVID-19 Syndrome: a Randomized Clinical Trial

Post-Acute Syndrome COVID-19 is a disease resulting from infection by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is estimated that between 10 and 35% of infected persons suffer symptoms afterwards, and in hospitalized patients it can reach 85%. These sequelae have individual, social and economic repercussions, so effective rehabilitation alternatives are necessary. Physical exercise is recommended as rehabilitation for these patients. Moreover, the implementation of m-Health supported interventions is a proven alternative in patients with Post-Acute COVID-19 Syndrome or other conditions, which improves therapeutic adherence and patient autonomy. Therefore, the development and evaluation of the effectiveness of an exercise-based m-Health system for application in patients with Post-Acute COVID-19 Syndrome responds to a need.

Our hypothesis is that a mobile health technology based on physical exercise recommendations for patients with Post-Acute COVID-19 Syndrome will improve fatigue, physical fitness, post-exertional dyspnea, pain intensity, anxiety, depression, cognitive function, and quality of life. Therefore, this project aims to evaluate the efficacy of the mobile health technology system (COVIDReApp) based on physical exercise recommendations for patients with COVID-19 Post-Acute Syndrome based on its results on fatigue, physical condition, post-exertional dyspnea, pain intensity, anxiety and depression, cognitive function and quality of life.

The achievement of the present project will serve to analyze the benefits of a physical exercise program in patients with COVID-19 Post-Acute Syndrome and identify those patients in whom the benefits will be greatest and whose implementation will have the highest priority.


Eligibility Criteria:
Eligible participants will be patients who have had COVID-19 at any time since the onset of the pandemic and even have Acute Post-CoVID-19 Syndrome, identified by their physicians and recruited from routine outpatient appointments at the Post-CoVID-19 Service of the Hospital Universitario Puerta del Mar, Cadiz, Spain.

Their physicians will give them an appointment for a future session in which potential participants will be provided with patient information and the consent form, and will be contacted approximately 48 hours later to discuss their willingness to participate.

Inclusion Criteria:

* Male and female patients.
* Over 18 years of age.
* Absence of cognitive and physical deficits that would preclude physical exercise.
* Owner of a smartphone with Internet access.
* Ability to understand and write in Spanish.

Exclusion criteria:

* Concomitant diseases that prevent physical exercise.
* Contraindications to physical exercise detected by physicians.
* Participation in moderate-intensity activities (more than 30 minutes and 3 times per week) at the time of study initiation.
Ioflupane I123 (DaTSCAN) and Positron Emission Tomography-computed Tomography Fludeoxyglucose (PET-CT FDG) to Assess Brain Function of Parkinson Patients' First Degree Relatives

Parkinson Disease is one of the most common neurodegenerative illnesses. First degree relatives of Parkinson patient are in high risk for developing the disease. We will try to detect early changes in brain metabolism before the appearance of Parkinson symptoms.

Participants: first degree relatives of diagnosed Parkinson patients that carry a gene mutation in either LRRK2 or GBA genes.

The examination results will be given to the participants by a doctor from the neurology department.


Eligibility Criteria:
Inclusion Criteria:

* healthy first degree relatives of diagnosed Parkinson patients

Exclusion Criteria:

* patients unable to understand and sign an informed consent
* minors
* people with psychiatric disorders or a history of major head trauma