cyrilzakka/clinical-trials huggingface dataset:
Study to Examine the Effect of Gastric Bypass Surgery on Venlafaxine ER Blood Levels

The purpose of the study is to determine whether a significant and predictable change in bioavailability of extended-release venlafaxine occurs following Roux-en-Y gastric bypass.


Eligibility Criteria:
Inclusion criteria:

- Approved to undergo Roux-en-Y gastric bypass surgery (cost of surgery is NOT included in the study)

Exclusion criteria:

* Pregnant
* Allergy to venlafaxine or desvenlafaxine
* Psychiatric hospitalization within the prior 12 months
* Active professional treatment for recent substance abuse within 12 months of abstinence
* Ongoing psychologic issues, such as personality disorders, difficulties as a trauma survivor, or difficulties with depression unless a stable, documented course of treatment by a licensed mental health professional is available
* Current use of any of the following medications/supplements: 5-hydroxytryptophan, almotriptan, amitriptyline, amoxapine, amoxicillin-clavulanate, amphetamine-dextroamphetamine, atazanavir, bupropion, cinacalcet, citalopram, clarithromycin, clomipramine, desipramine, desvenlafaxine, dextroamphetamine, dextromethorphan, doxepin, duloxetine, eletriptan, entacapone, escitalopram, fluoxetine, fluvoxamine, frovatriptan, haloperidol, imipramine, isocarboxazid, itraconazole, jujube seed extract, linezolid, maprotiline, methylene blue, metoclopramide, metoprolol, milnacipran, mirtazapine, naratriptan, nefazodone, nelfinavir, nortriptyline, paroxetine, phenelzine, procarbazine, protriptyline, quinidine, rasagiline, ritonavir, rizatriptan, saquinavir, selegiline, sertraline, St. John's wort, sumatriptan, tapentadol, terbinafine, toremifene, tramadol, tranylcypromine, trazodone, trifluoperazine, trimipramine, tryptophan, L-tryptophan, venlafaxine, vilazodone, zolmitriptan
Study of SHR-A1811 in HER2-expression Advanced Breast Cancer with Brain Metastases

This study aimed to evaluate the use of SHR-A1811 in HER2-expression Advanced Breast Cancer patients with brain metastases.


Eligibility Criteria:
Inclusion Criteria:

1. Females ≥18 yrs old;
2. Pathologically confirmed HER2-positive or HER2-low advanced breast cancer;
3. At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;
4. Without prior cranial radiation and had no indication for immediate local treatment or refuse to local treatment;
5. More than 2 weeks from last systemic treatment; patients with new brain lesions after craniocerebral surgery were admitted if no radiotherapy was performed. Patients with HER2-Low disease must not have systemic treatment for brain metastases.
6. Prior HER2-target treatment, endocrine therapy and chemotherapy was allowed;
7. Life expectancy is not less than 6 months.
8. Adequate function of major organs.

Exclusion Criteria:

1. Leptomeningeal involvement;
2. CNS complications requiring emergency neurosurgical intervention (e.g. excision, shunt tube placement);or uncontrolled symptomatic brain metastases;
3. Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor;
4. Patients who had progressed on previous HER2 tyrosine kinase inhibitor therapy were excluded from Arm 2, and those who had progressed on previous bevacizumab therapy were excluded from Arm 3;
5. No concurrent antitumor therapy for metastatic cancer other than the study treatment;
6. Antitumor radiotherapy, chemotherapy, surgery, targeted therapy, or immunotherapy within 2 weeks or endocrine therapy within 1 week prior to enrolment;
7. Participated in other drug clinical trials within 4 weeks before admission;
8. History of clinically significant lung disease；
9. Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.
10. According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.).
11. Any other conditions that researchers believe that patients are unsuitable for this study.
Effect of Shock Wave Therapy on Truncal Obesity and Lipid Profile in Obese Post Menopausal Women

This study aimed to evaluate the effect of six weeks extracorporeal shockwave therapy (SWT) on truncal obesity and serum lipids in obese postmenopausal women

Truncal obesity occurs when the excess abdominal fat around the stomach and abdomen has accumulated to the point where it is likely to have a negative influence on health , increased visceral abdominal fat (VAF) is directly related to abdominal obesity (AO), which is also linked to endothelial dysfunction, inflammation, insulin resistance, diabetes mellitus, hypercholesterolemia, hepatic steatosis metabolic syndrome \[MetS\] and cancer.

High density lipoprotein (HDL) cholesterol, often known as cardio protective cholesterol, increases in a hypoestrogenic state such postmenopausal status, whereas triglyceride (TG), total cholesterol, and LDL cholesterol levels fall The prevention of CVD and dyslipidemia depends on the management of truncal obesity, and the reduction of serum lipid levels.

Extracorporeal shock wave therapy (ESWT) has lately been popular for treating fat-related disorders by altering the permeability of lipocyte membranes, improving blood flow and hastening macrophages' clearance of debris so cellulite, body contouring and localized fat can all be treated with the safe and non-invasive ESWT technology because to its mode of action in biological tissue In order to identify the best methods for treating abdominal obesity and prevent the risk of developing cardiovascular disease (CVD) in post-menopausal women. The current randomized controlled trial aimed to determine the effect of extracorporeal shockwave therapy (SWT) on truncal obesity and serum lipids in obese postmenopausal women.

Eligibility Criteria:
Inclusion Criteria:

* Obese Post menopausal women Body mass index more than or equal 30kg/m2 Waist circumference more than or equal 88 cm Waist hip ratio more than or equal 0.88cm Women not engaged in any procedure to treat obesity or received medication from 6 months

Exclusion Criteria:

* women diagnosed with malignancies or received chemical or radiotherapy or hormone replacement therapy or corticosteroids or diagnosed with liver disease or active infection or trauma
Randomized Comparison of ExoSeal® and Angio-Seal Vascular Closure Devices: The CLOSE-UP II Trial

Is the ExoSeal VSD non-inferior to Angio-Seal vascular closure device (VSD) in the incidence of adverse access site related events at 30 days.

Prospective, randomized (1:1) controlled, single blind, single center study in 2000 percutaneous coronary intervention (PCI) patients comparing the ExoSeal VCD (test device) to the AngioSeal VCD (standard comparator). In-hospital and 30 days safety and efficacy endpoints and 6 months safety endpoints will be reported.

Eligibility Criteria:
Inclusion Criteria:

* Should be able to provide valid informed signed consent
* PCI procedure including treatment by balloon and/or stent
* PCI indicated by silent ischemia, stable angina pectoris, non-ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI)

Exclusion Criteria:

* Only coronary angiography
* Multiple punctures
* Active infection
* Groin haematoma before the closure procedure
* Sheath size \> 7 French
* Known pseudoaneurysm or arteriovenous (AV)-fistula in the ipsilateral groin
* Prior arterial surgery in abdomen and/or lower extremities
* Cardiogenic shock
* Life expectancy less than one year
* The patient is a female of childbearing potential with possible pregnancy or a positive pregnancy test within 7 days before the index procedure or is lactating
* Simultaneous or planned subsequent femoral vein access
* Allergy to any of the components in the closure material left in the groin
* Puncture on same site \< 30 days
* Peripheral artery disease patients can be included at operator´s discretion except if heavy calcification is present at the access site which at the operator's discretion precludes insertion of the VCD
Effectiveness of the FairCare System for Patients With Advanced Illness

This study of the FairCare Program (FC) is designed to address end of life (EOL) care delivery issues by reducing barriers to effective EOL care among health care providers, family members, surrogates, and Chronic Heart Failure (CHF) patients using a comprehensive, multi-pronged approach delivered by a care coordinator and supported by an interdisciplinary team.

Background:

This study of the FairCare Program (FC) is designed to address end of life (EOL) care delivery issues by reducing barriers to effective EOL care among health care providers, family members, surrogates, and Chronic Heart Failure (CHF) patients using a comprehensive, multi-pronged approach delivered by a care coordinator and supported by an interdisciplinary team.

Objectives:

Evaluate the impact of FC on: 1) improving the quality of life (QOL) and health care delivery for CHF patients with advanced illness, (i.e. ejection fractions of 35% or less, or assessed as level III or IV on the NYS Heart Association Classification System); 2) addressing their fears about dying; 3) increasing their use of Advance Directives (ADs); and 4) improving provider compliance with ADs. Also, describe trends that may occur in disease-specific QOL, survival, and health care use and cost.

Methods:

The study employs a randomized control group design. There are two treatment arms, the FC treatment condition, and the usual care (UC) control condition. Assessments for improving quality of life (QOL), and quality of care delivery are taken at baseline, and at three and six months. Assessments of AD use, i.e. frequency of formulation and documentation of ADs, are taken at baseline, three and six months at one year and 18 months. Because data about compliance with ADs and utilization and cost may not be fully comprehensive until patients' deaths, to maximize the sample size for these variables, and hence the power of the study to detect difference in these outcomes, data on compliance with ADs will be collected in the final year of the study, and data on utilization and cost will be aggregated in monthly intervals and collected from baseline to 18 months. One year of VA pre-intervention health care utilization and cost data will also be collected to assess baseline utilization and to control for any pre-existing differences in the propensity of patients to use health care services. Also, an intention to treat methodology will be used during data analyses.

Status:

The study ends 9-30-04, data for VA cost, Medicare cost, consistency of medical care with patient preferences, and survival, are being collected and analyzed for the final report.

Eligibility Criteria:
Inclusion Criteria:

Ejection fraction 35% or less and classification at level 3 or 4 of the New York State Heart Classification System and surrogates of patients meeting this criteria.

Exclusion Criteria:
Noninvasive Brain Stimulation to Evaluate Neural Plasticity After Stroke

The purpose of this study is to examine how different areas in the brain interact with each other and how using brain imaging and brain stimulation approaches can influence these interactions.

Subcortical strokes affect small vessels deep in the brain, and typically present with motor hemiparesis. The investigator will assess the effects of Transcranial Magnetic Stimulation (TMS) on motor function and examine how different areas in the human brain interact with each other using brain imaging and brain stimulation. The investigator will also evaluate the capacity for noninvasive stimulation to transiently modify brain activity supporting arm movement.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-85 years
2. Middle cerebral artery stroke
3. Individuals with a first time stroke that affects the corona radiata and/or internal capsule

Exclusion Criteria:

1. Age outside the age range of 18-85 years
2. Signs of dementia (score \< 24 on the Montreal Cognitive Assessment)
3. Aphasia (score \< 13 on the Frenchay Aphasia Screen)
4. History of head trauma
5. History of a major psychiatric diagnosis
6. History of a neurodegenerative disorder
7. History of substance abuse
8. Contraindications to Transcranial Magnetic Stimulation
The Sahlgrenska Anti-VEGF Study

The study investigates whether patients treated for neovascular (wet) age-related macular degeneration (AMD), with intravitreal injection with bevacizumab (Avastin) after two years need more injections with retained therapy response compared to patients being treated with intravitreal injection with aflibercept (Eylea).

The study also aims to evaluate if there is a difference in best-corrected visual acuity, macular thickness, recurrence interval, durability, cost efficiency, as well as vision-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

Signed informed consent.

≥50 years, regardless of gender.

Diagnosed with the neovascular (wet) form of age-related macular degeneration through diagnosed neovascular vascular membranes with OCT-A and, if necessary, also FA / ICG, according to clinical routine.

Distance visual acuity ≥34 (ETDRS) on the current study eye.

Exclusion Criteria:

Other eye disease in the current study eye that affects visual acuity or the possibility of examining fundus, according to the investigator's assessment.

Previously received treatment for the neovascular (wet) form of age-related macular degeneration.

Diagnosed with diabetes (all types).

Degenerative state of the macula that prevents vision improvement such as central areolar atrophy or other pronounced dry AMD or fibrosis, in the current study eye.

Other choroidal neovascularization (CNV) of the type PCV or due to grave myopia i.e. ≥ 6.0 diopters (D) or secondary to other retinal disease, in the current study eye.

Unregulated intraocular pressure (IOP) \> 30 mmHg despite pharmacological treatment in the current study eye.

Have had a stroke or heart attack ≤6 months ago.

Inability to access information (e.g. due to dementia) or inability to conduct examinations (e.g. ETDRS examination), according to the investigator's assessment.

Inability to receive oral and written information in Swedish (in need of an interpreter).

Included in another intervention study.

Fertile woman i.e. a woman who has had menstruation for the past 12 months or has not undergone permanent sterilization (hysterectomy, bilateral salpingectomy or bilateral oophorectomy).
A Phase III Clinical Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops

This study was a randomized, double-blind, placebo-controlled, multicenter, superiority design, phase III clinical trial to compare the efficacy and safety of two low-concentration atropine sulfate eye drops versus placebo in delaying myopia progression in children.

Eligible subjects were screened and randomly assigned to the placebo control group, the lower dose group, and the lower dose group. Subjects received the study drug in both eyes, 1 drop each time, once every night before sleep, for continuous administration.A total of 526 subjects were planned to be enrolled。

Statistical analyses were performed with the use of SAS software, version 9.4, without any specific description. All statistical tests were two-sided at a 0.05 level.

Eligibility Criteria:
Inclusion Criteria:

1. Child (female or male) aged 6 to 10 years.
2. Myopia (SER of at least -0.50 D and no more myopic than -6.00 D) in each eye as measured by cycloplegic autorefraction.
3. If present, astigmatism of ≤1.50 D in each eye as measured by cycloplegic autorefraction.
4. Anisometropia SER of \< 1.50 D as measured by cycloplegic autorefraction.

Exclusion Criteria:

1. History of any disease or syndrome that predisposed the subject to severe myopia (e.g.,Marfan syndrome, Stickler syndrome, retinopathy of prematurity).
2. History in either eye of abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus,spherophakia).
3. Chronic use of any topical or systemic antimuscarinic/anticholinergic medications (e.g.,atropine, scopolamine, tropicamide) within 21 days prior to screening and/or anticipated need for chronic use during the study period (i.e., more than 7 consecutive days in 1 month or more than 30 total days in 1 year).

   Use of cycloplegic drops for dilated ocular exam was allowable.
4. Heart rate persistently (for more than 10 minutes) \> 120 beats per minute.
5. Allergy to study drugs.
Inhibition of the Renin Angiotensin System Plus Corticosteroids for the Treatment of Proteinuria in IGA Nephropathy

TO ASSESS THE EFFICACY OF THE RENIN ANGIOTENSIN SYSTEM PLUS STEROIDS TO DECREASE THE AMOUNT OF PROTEINURIA IN IGA NEPHROPATHY

Patients whose proteinuria was \> 0.5 g/day were to receive enalapril plus valsartan coupled with oral 0.5 g/day of methylprednisone for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* PATIENTES WITH IGA NEPHROPATHY WITH PROTEINURIA OVER 0.5 G/DAY

Exclusion Criteria:

* MALIGNANCY, RENAL FAILURE
Cardiac Anesthesia Registry Including Biosignal Database for Prognostication of Postoperative Renal Outcome

AKI(Acute Kidney Injury) is a common complication after cardiac surgery which is associated with increased mortality and morbidity. Collecting perioperative biosignal data and studying their association with renal outcomes can help improve kidney injury, mortality, and morbidity in cardiac surgical patients. Furthermore, the occurrence of AKI, length of hospital stay, and recovery of renal function after discharge are closely associated with the development of chronic kidney disease (CKD). Therefore, regular monitoring of renal function and related indicators in cardiac surgical patients can help improve long-term outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Aged 19 years and older scheduled for cardiac surgery using CPB

Exclusion Criteria:

* emergency operation, the patient is foreigner or illiterate and unable to read the consent form
A Study of BMS-986171 in Healthy People to Assess Safety, to Measure Blood Levels of Drug, and to Find Out What the Drug Does to the Body

The purpose of this study is to assess safety, to measure blood levels of drug, and to find out what the drug does to the body.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Age 21 to 55 years (Part A,B, and C)
* BMI 30-40 (Part A or Part B); BMI 20-35 (Part C). BMI = weight (kg)/ \[height (m)\]

Exclusion Criteria:

* Any significant medical illness
* Cannot tolerate subcutaneous injections, or having blood samples taken
* Smoking more than 10 cigarettes/day
* History of allergy to pegylated compounds or of hypersensitivity to protein based therapeutics.
* HIV, Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection.
* Pregnancy
A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis

This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be at least 18 years of age.
* Males and females with a documented diagnosis of UC at least 4 months prior to entry into the study.
* Subjects with moderately to severely active UC based on Mayo score criteria.
* Subjects must have failed or be intolerant of at least one of the following treatments for UC:

  * Corticosteroids (oral or intravenous).
  * Azathioprine or 6 mercaptopurine (6 MP).
  * Anti TNF therapy.

Exclusion Criteria:

* Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease.
* Subjects with disease limited to distal 15 cm.
* Subjects without previous treatment for UC (ie, treatment naïve).
* Subjects displaying clinical signs of fulminant colitis or toxic megacolon.
Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction

This project aims to assess the ability of cardiac imaging (cardiac MRI and Doppler-echocardiography) post-processing tools to predict a combined end-point of intraventricular thrombosis, silent brain infarcts, clinical stroke and peripheral arterial embolism in patients with first acute myocardial infarction and ventricular dysfunction.

An acute myocardial infarction (AMI) is a clinical situation that entails an increased risk of both subclinical and clinically devastating cardioembolic events. This increased risk of embolic phenomena may be related to blood stasis caused by alterations in the blood flow inside the left ventricle (LV) after AMI. Using flow velocity measurements obtained by cardiac MRI and Doppler-echocardiography it is possible to quantify the stasis in the LV and assess its relation to the risk of embolic events. The ability of cardiac imaging (cardiac MRI and Doppler-echocardiography) post-processing tools to predict embolic events in a cohort of 92 patients with a first AMI and left ventricular dysfunction shall be addressed. The potential confusion generated by the possible existence of paroxysmal AF will be controlled by implanting cardiac monitoring devices in random order in a subset of patients.

Eligibility Criteria:
Inclusion Criteria:

1. First ST elevation AMI undergoing (or not) revascularization.
2. Sinus rhythm in the first 24 hours of the AMI.
3. Written informed consent. ( 4) Left ventricular ejection fraction \< 45% measured by echocardiography in the first 24-72 hours after AMI symptoms onset.

Exclusion Criteria:

1. Implantable defibrillation or stimulation devices not compatible with MRI.
2. Killip-IV class or other shock situations or marked peripheral hypoperfusion.
3. Aborted sudden death or other causes of possible acute brain damage attributed to cerebral hypoperfusion.
4. Hemodynamically significant valvular disease or prosthetic heart valves.
5. Claustrophobia that impedes MRI scanning.
6. Atrial fibrillation (AF) in the first 24 hours after AMI.
7. Carotid Artery Disease diagnosed with stenosis greater than 50%.
8. Full oral anticoagulation prior to admission or indication of anticoagulation.
9. Defined pro-thrombotic conditions.
10. History of previous stroke in the last 6 months.