cyrilzakka/clinical-trials huggingface dataset:
MCB Vs EUS-FNA for Preoperative Pathological Evaluation of Gastric SMT

Gastrointestinal stromal tumors (GISTs) are the most common submucosal tumors (SMTs) of the stomach. The 2022 European Society of Oncology ESMO Diagnosis and Treatment Guidelines recommend that GISTs undergo biopsy with a clear pathological diagnosis and should be removed unless there are significant complications. But currently, the diagnostic rate of EUS-FNA for upper gastrointestinal subcutaneous lesions is less than 60%. In recent years, mucosal cutting biopsy (MCB) has become an effective method for diagnosing SMTs. Regardless of whether the SMTs are large or small, the application of MCB technology can quickly obtain pathological tissue under direct visualization, and its immunohistochemical pathological diagnosis rate is relatively satisfactory. MCB technology has great potential in the biopsy of SMTs, but there is currently no comparison of results between two technologies in randomized controlled trials. The purpose of this study is to design a randomized controlled trial to compare the diagnostic rates of EUS-FNA and MCB techniques for tissue pathology (including immunohistochemistry) of SMTs, in order to improve the diagnostic accuracy of SMTs in our hospital and improve patient prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Endoscopic evaluation considers gastric submucosal tumors (SMTs) with a diameter of ≥ 15mm

Exclusion Criteria:

* Endoscopic non bulging lesions.
* The upper gastrointestinal lesions measured by Endoscopic Ultrasonography(EUS) are less than 15 mm.
* Lesions that do not require tissue collection (such as lipomas, varicose veins)
* Patients with cystic lesions
* The patient has uncorrectable coagulation dysfunction (International Normalized Ratio (INR)\>1.5 or platelet count\<50x109)
* Patients with portal hypertension
* Patients with a history of upper gastrointestinal surgery
* Pregnant women
* Patients who refuse to participate in this clinical trial
Blood Cell Response to Exercise

Moderate exercise is recommended to improve cardiovascular health in obese and overweight people particularly with metabolic syndrome (MetS) that have hypertension, elevated fasting blood sugar, and elevated blood lipids. This study is being done to determine how platelets respond when a person performs an initial period of moderate exercise.


Eligibility Criteria:
Inclusion Criteria:

* 30-60 years old
* BMI \>/=26 and \<40 kg/m2
* not planning to or currently attempting to gain or lose weight
* low reported omega-3 fatty acid intake per Omega-3 Checklist
* Metabolic Syndrome as define 3/5 of the following:Waist circumference: men \> 102 cm women \> 88 cm, triglycerides \> 150 mg/dL, HDL cholesterol: men \< 40 mg/dL women \< 50 mg/dL,Blood pressure \>130/\>85 mmHg,Fasting glucose \> 100 mg/dL (Hypertensive subjects are eligible if taking thiazide diuretics NOT ACE inhibitors beta blockers)

Exclusion Criteria:

* smoke or use tobacco or nicotine in any form (including pills and patches)
* take any medication that makes you unable to exercise
* have established cardiovascular, pulmonary, and/or metabolic disease such as diabetes
* have uncontrolled hypertension
* have alcohol, anabolic steroid, or other substance abuse issues
* consume more than 3 alcoholic drinks/week
* have joint or muscle injuries that affects your ability to exercise
* have cancer (other than skin cancer or carcinoma in situ of the cervix
* pregnant or lactating
* currently exercise regularly
* taking non-steroidal anti-inflammatory medications (aspirin, Aleve, Advil, ibuprofen, naproxen
* take lipid modifying medications such as statins (Lipitor, Zocor)
* take medications for blood glucose such as insulin or metformin
* take medications that affect platelet functions (Plavix)
* taking omega-3 supplements (fish or flax oil)
Combination Therapy of Low Doses of rFVIIa and FEIBA for Severe Hemophilia A Patients With an Inhibitor to Factor VIII

Patients with severe hemophilia and inhibitors can be treated effectively by Activated Prothrombin Complex Concentrates (APCC, eg. FEIBA) or High dose recombinant factor VIIa (rFVIIa). Rarely, such patients develop refractoriness to these products for whom therapy with sequential FEIBA and rFVIIa has been recently suggested.

The impetus for the present report was a hemophilia A patient with high titer inhibitor (1300BU) who had life threatening hematuria that was resistant to repeated doses of 400µg/kg rFVIIa up to a cumulative dose of 1200 µg/kg given over 6-9 hours.

Thrombin generation (TG) tested in vitro was consistent with resistance to high concentrations of rFVIIa but yielded good response to combinations of low doses of rFVIIa+FEIBA. In a desperate attempt to control the bleeding, concomitant therapy of 25 U/kg FEIBA and 40µg/kg rFVIIa was infused and resulted in arrest of bleeding within minutes. Over a span of about one year the patient has been successfully treated by this combination for more than 200 bleeding episodes in muscles and joints.

Inhibitor patients with HR inhibitors were eligible for study enrollment. After consent blood was drawn and ex- vivo spiked with rFVIIa/FEIBA and combinations, assayed by thrombin generation tests.

The combination yielding sufficient hemostasis was depicted for patients' therapy of future bleeding episodes.

Following actual therapy hemostasis and safety parameters were monitored.

Eligibility Criteria:
Inclusion Criteria:

* Hemophilia patients with inhibitors
* Patients signing informed consent

Exclusion Criteria:

* Patients under 16 or above 65
* Patients with allergic reaction or adverse events in previous use the concentrates
* Patients with high risk of thrombosis
Second-Look Ultrasound Post Contrast-Enhanced Mammography for Additional Lesions Characterization

This study investigates the utility of second-look ultrasound (US) following contrast-enhanced mammography (CEM) to characterize additional lesions detected during routine breast imaging.

The goal is to assess the diagnostic accuracy and clinical value of combining CEM with targeted ultrasound to improve lesion characterization and guide biopsy decisions.

Eligibility Criteria:
INCLUSION CRITERIA:

* Patients undergoing contrast-enhanced mammography for diagnostic or surveillance purposes.
* Identification of additional lesions on CEM requiring further evaluation.
* Ability to provide informed consent.

EXCLUSION CRITERIA:

* Known breast cancer diagnosis without suspicion of additional lesions.
* Contraindications to ultrasound or contrast agents.
* Patients with incomplete imaging data.
Dynamic Balance Training in Multiple Sclerosis

This study will test a new technique for improving balance while walking in people with multiple sclerosis (MS). The technique focuses on having people with MS safely practice walking on simulated, uneven terrain that challenges balance and more accurately mimics walking in the community. The goal is to improve balance while walking in order to improve mobility and decrease the risk of falls. Recently, we developed a state-of-the-art treadmill system that allows us to create a challenging walking environment by placing a treadmill onto a motion base. We are able to simulate uneven terrain through movements of the walking surface while maintaining a safe walking environment. We will use this system to conduct tests of balance while walking and to train people to walk on uneven surfaces. Our objective is to evaluate the use of uneven terrain for training gait and balance in people with MS. Participants will undergo a four-week training protocol designed to disrupt and challenge balance while walking. We anticipate that training on uneven terrain will enhance gait stability, improve overall walking function and balance and increase balance confidence compared to training on a stable surface.


Eligibility Criteria:
Inclusion Criteria:

* Participants have been clinically diagnosed with multiple sclerosis
* Must be capable of walking 10 meters independently with no physical assistance
* Must be able to ascend/descend a small staircase (5 steps)
* Medically stable
* Able to give informed consent

Exclusion Criteria:

* they suffer from cognitive deficits that prevent them from following 1 step commands
* unable to give informed consent
* if they suffer from significant cardiovascular problems, respiratory failure, major orthopedic problems, or other medical conditions that affect balance (e.g. diabetic neuropathy, myopathy, or vertigo)
* Significant medical comorbidity or concurrent illness limiting their capacity to conform to study requirements
Effects of rTMS Based on Hemodynamic Activity for Language Recovery in Early Poststroke Aphasia

The aim of this study is to assess the safety and clinical efficacy of repetitive transcranial magnetic stimulation (rTMS) based on hemodynamic brain activity pattern with functional near infrared spectroscopy (fNIRS) in early poststroke nonfluent aphasia patients.

Most conventional rTMS studies employed an inhibitory low frequency protocol for the contralesional homologs of Broca's area.

In the present randomized controlled trial, investigators will perform fNIRS prior to rTMS treatment to select the stimulation method. Stimulation site (perilesional or contralesional) and frequency (excitatory high or inhibitory low) will be determined by activation pattern from the fNIRS with language task in individual patients.

The patient who shows a dominant neural activity at perilesional Broca's area on fNIRS scanning will be randomly allocated into two groups: high frequency stimulation group and sham stimulation group. If a patient shows a dominant neural activity at contralesional homologs of Broca's area on fNIRS scanning, the patient will be allocated to a low frequency stimulation group.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 yrs old
* Right-handed
* Radiologically confirmed left hemisphere stroke within 6 months
* Fluent in Korean
* First ever stroke
* Non-fluent (motor-dominant) aphasia
* Written informed consent

Exclusion Criteria:

* Previous medical histories of stroke, cerebral vascular operation,
* Seizure
* Patients with traumatic brain injury
* Unable to perform the language task
* Severe cognitive impairment (MMSE less than 16)
* Skin lesion in the stimulation site of scalp
* Metal implants in the body (cardiac pacemaker or aneurysm clip)
* Pregnancy, breastfeeding
A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder

This study will evaluate the safety, tolerability and efficacy of darifenacin, in the long-term treatment of adult patients with overactive bladder.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with overactive bladder who completed a previous darifenacin short-term trial.
* Patients capable of independent toileting and able of independently completing the patient diary.

Exclusion Criteria:

* Patients in whom the use of anticholinergic drugs was contraindicated
* Evidence of severe liver disease
* Patients with other clinically significant urinary or gynecological conditions

Other protocol-defined inclusion/exclusion criteria may apply.
Omics Sequencing of Exosomes in Body Fluids of Patients With Acute Lung Injury

The exosomes in the experimental group and the control group were sequenced to find the difference of the two groups, providing a basis for subsequent basic research.

This study is an observational study, mainly collected by infection, trauma, burns and other non cardiac causes without any related comprehensive character drug treatment of acute respiratory distress (ARDS) in patients with blood, urine or alveolar lavage fluid specimens, used to extract exosomes for omics sequencing, relevant histomorphic variations in exosomes of this disease were obtained, In addition, functional verification of genes or proteins with different changes will be carried out to provide clinical basis for subsequent basic research.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria of experimental group:

* Signed informed consent voluntarily;
* Age: \>18 years old, gender: no restrictions ;
* Patients with known clinical manifestations of respiratory impairment or new/aggravated respiratory symptoms diagnosed within one week of onset according to the Berlin definition guidelines.

Control group inclusion criteria:

* Age ≥18 years old (including 18 years old), male and female;
* Male weight ≥50 kg, female weight ≥45kg, and body mass index (BMI) between 19 and 26(inclusive), BMI= weight (kg)/ height (㎡);
* No smoking, alcohol addiction, no history of drug abuse;
* No diabetes, asthma, copd, chronic renal insufficiency and other basic diseases; No history of major diseases or infectious diseases (including hepatitis B, hepatitis C, HIV, syphilis);
* Those who have not taken drugs recently.

Exclusion Criteria:

Exclusion criteria of experimental group:

* Patients with diabetes, chronic renal insufficiency, malignant tumors and other basic diseases;
* severe malnutrition;
* Pregnant or lactating women;
* The researcher judged that he was not suitable to participate in this study.

Exclusion criteria for the control group:

* pregnant or lactation women;
* severe malnutrition;
* The researcher judged that he was not suitable to participate in this study.
Mothers With a History of Depression and Their 10-14 Year Old Daughters

The purpose of this study is to investigate risk factors associated with depression and how such factors might be transmitted cross-generationally. The investigators are conducting an integrative assessment of emotion regulation and stress reactivity in a group of mothers with and without a history of depression and their daughters.

The purpose of this study is to investigate risk factors associated with depression and how such factors might be transmitted cross-generationally. We are conducting an integrative assessment of emotion regulation and stress reactivity in a group of mothers with and without a history of depression and their daughters. We use a range of methodologies to evaluate these processes, including self-report measures, information-processing performance, HPA-axis functioning and reactivity, and neural responses to emotional stimuli following exposure to stressful experiences.

Eligibility Criteria:
Inclusion Criteria:

* Eligible mothers must read and speak English fluently and have a child between the ages of 9 and 15 years old.
* Mothers must either have no history of psychopathology or have a history of depression during their child's lifetime.

Exclusion Criteria:

* Eligible mothers cannot:

  * currently be in treatment for drug or alcohol abuse
  * have significant symptomatology related to psychopathology outside of depression
  * have a medical history of neurological injury or impairment.
* Mothers who meet the requirements for inclusion in the control group must not have a history of any Axis I disorder.
Motivation Matters Study

The study aims to develop and evaluate the efficacy and causal mechanisms of an interactive SMS intervention to optimize individual health and secondary HIV prevention benefits of ART in HIV-positive FSWs.

Antiretroviral therapy (ART) is highly effective at reducing the infectiousness of HIV-positive people, and is considered the cornerstone of all new HIV prevention approaches. A critical question is how to harness the potency of ART to reduce transmission from female sex workers (FSWs), a key population that has been central to HIV transmission in Africa for more than 25 years. In high prevalence countries like Kenya, FSWs represent about 1% of the population, yet contribute to one in seven (14%) new HIV infections. Targeting treatment as prevention (TasP) to FSWs could efficiently reduce HIV transmission on a population level. Effective TasP will require higher levels of ART adherence than those achieved in typical treatment programs. The rapid spread of mobile technology in Africa provides unique opportunities for mobile health (mHealth) interventions, which have been shown to be acceptable to providers and patients, and can improve ART adherence and suppression of plasma HIV viral load.

The ability of mobile (SMS) interventions to support ART adherence in key populations like FSWs and unique clinical scenarios such as TasP has yet to be evaluated. The investigators will answer these fundamental questions by addressing the following aims: 1) To use a qualitative rapid assessment and development approach to craft a theory-based, individualized, interactive SMS intervention, grounded in the Theory of Information, Motivation, and Behavior (IMB), to support ART adherence in HIV-positive FSWs, 2) To compare individualized, interactive SMS to standard care in achieving undetectable HIV VL 6 months post ART initiation in a randomized controlled trial (RCT) with 210 FSWs and 3) To administer an adaptation of the LifeWindows Information - Motivation - Behavioral Skills ART Adherence Questionnaire (LW-IMB-AAQ) to understand the mechanism of our SMS intervention's effect by comparing perceptions of support and motivation to adhere to ART in FSWs who received the intervention versus standard care.

Our overarching goal is to develop and evaluate the efficacy and causal mechanisms of an interactive SMS intervention to optimize individual health and secondary HIV prevention benefits of ART in HIV-positive FSWs. The aims of this project proceed sequentially from developmental (Aim 1) through implementation of the intervention (Aim 2) to evaluation of the fit with the behavioral model (Aim 3).

Eligibility Criteria:
Inclusion Criteria:

* More than 18 years or emancipated minor
* Has access to mobile phone
* Self-identifying female sex worker
* Willing to receive study SMS messages
* HIV-positive (any WHO stage or CD4)
* Able to read or have someone else read
* ART naïve
* Informed consent obtained and signed.

Exclusion Criteria:

* Plans to move away in next 6 months
* Contraindication to ART
A Trial of Digoxin Before Second-Trimester Abortion

The purpose of our study is to determine the optimum route for the injection of digoxin prior to second-trimester surgical abortion.

Of the 1.2 million abortions each year in the U.S., approximately 12% take place in the second trimester of pregnancy. The preferred technique for second-trimester pregnancy termination is dilation and evacuation, or D\&E. In 2006, 144,000 D\&Es were performed in the U.S. Clinicians often achieve preoperative fetal asystole by a maternal transabdominal injection of digoxin. Prior to D\&E, providers use digoxin to induce fetal death 1) for providers' preference to facilitate surgical delivery of the fetus, and/or 2) for patients who express a desire for fetal death prior to the abortion.

The use of digoxin to achieve preoperative fetal asystole is widespread, yet there are no evidence-based standards for how to best achieve fetal asystole prior to D\&E. Digoxin has been administered by intracardiac, intrathoracic, intrafetal and intra-amniotic routes, with doses varying from 0.25 to 2mg. Clinicians who use digoxin usually inject it one to two days before the D\&E. Only one study has assessed the effectiveness of digoxin at varying dosages ; this was a retrospective and nonrandomized analysis. Published failure rates are based on small numbers of patients and are therefore imprecise. Intrafetal digoxin injection may be more effective, but is a technically more difficult procedure than intra-amniotic injection. The pharmacodynamics of digoxin when used for feticide are also unknown. The objective of this study is to determine the optimum route for digoxin injection (intrafetal or intra-amniotic) that will maximize patient safety while maintaining effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* English or Spanish speaking
* be able to give informed consent
* documented fetal cardiac activity.

Exclusion Criteria:

* significant medical illness or cardiovascular disease
* current use of cardiac or antihypertensive medications
* cardiac arrhythmia on preoperative EKG
* multiple gestation
* morbid obesity (BMI greater than 40)
* known digoxin allergy
Registry of Mastectomy for Breast Cancer Risk Reduction

This is a registry for patients who have a risk-reduction mastectomy ("prophylactic mastectomy") due to being at high risk for developing breast cancer, followed by breast reconstruction. Eligible patients include those who have a breast cancer-related gene, a strong family history of breast cancer, or a personal history of high-risk conditions such as cancer in the other breast or ductal carcinoma in situ (DCIS). Patients are enrolled in the registry before surgery, and are followed for up to ten years afterwards. In addition to studying medical outcomes, we will periodically survey patients for quality-of-life issues and psychological well-being. There is no compensation for being enrolled in this registry. This registry is conducted through the Department of Plastic Surgery at Georgetown University Hospital, and is a sub-registry to the Fisher Familial Cancer Registry at the Lombardi Comprehensive Cancer Center at Georgetown University.


Eligibility Criteria:
Inclusion Criteria:

* Patients at an elevated risk for breast cancer.

Exclusion Criteria:

* None.
Effect of Tibet Rhodiola Capsule on Hypoxia and Cardiovascular Risk Factors in Patients With Obstructive Sleep Apnea

The purpose of this study is to evaluate the effect of Tibet Rhodiola Capsule on hypoxia and the cardiovascular risk factors in patients with mild to moderate OSA.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years, males or females;
2. HSAT or PSG testing within recent 3 months;
3. AHI 5-30 and lowest oxygen saturation\<85%;
4. Refuse to accept CPAP, Mandibular orthosis device, surgery, or other medications to improve OSA;
5. Written informed consent.

Exclusion Criteria:

1. History of CPAP, Mandibular orthosis device, surgery, or other medications to improve OSA;
2. Significant central sleep apnea;
3. Histories of other sleep disorders: insomnia, chronic sleep deprivation, long-term use of sleeping pills or sedatives, restless legs syndrome;
4. Histories of underlying heart disease (cardiomyopathy, myocarditis, pericarditis or severe valvular disease), cardiogenic shock and heart failure (NYHA or Killip class 3-4), persistent atrial or ventricular arrhythmias;
5. History of myocardial infarction, coronary revascularization, and a known degree of stenosis \> 75% of the coronary lesions;
6. Histories of known serious liver dysfunction (ALT or AST levels above 3 times the normal limit), renal insufficiency (GFR\<30ml/min), moderate and severe chronic obstructive pulmonary disease, and pulmonary arterial hypertension;
7. Patients with malignant tumors, lymphoma and neuropsychiatric disorders;
8. Patients with major surgery or trauma within 3 months, and active bleeding or cerebrovascular accident within 6 months;
9. History of anemia (hemoglobin\<90g/L) or thrombocytopenia (thrombocyte \<90×10\^9/L);
10. Breastfeeding, pregnant, or potentially fertile women;
11. Patients who have known to be allergic to Tibet Rhodiola Capsule or its components or patients with serious adverse effect;
12. Participation in other clinical trials in recent 3 months;
13. Patients who cannot complete this trial or comply with the protocol.