cyrilzakka/clinical-trials huggingface dataset:
Simplifying Menstrual Regulation (MR): Post Abortion Care in Pakistan

This study is an additional component of protocol 6005, titled Simplifying Menstrual Regulation (MR): Exploring the role of at-home semi-quantitative pregnancy tests for follow-up to menstrual regulation service provision in Pakistan. The study seeks to pilot a self-assessment checklist that will help women, who receive medical services for incomplete abortion, correctly identify warning signs and symptoms and determine whether to return to the clinic. The checklist can serve as a useful resource to help with the timely identification of women who need additional care and can help streamline service delivery. In addition, this study will provide important data on the role of misoprostol at varying levels of health services offering an array of treatments for incomplete abortion.


Eligibility Criteria:
Inclusion Criteria:

* Vaginal bleeding during pregnancy
* Open cervical os.
* No signs of severe infection, defined as at least one of the following of: 1) foul smelling discharge, 2) fever \> 38 degrees C , 3) uterine tenderness
* No hemodynamic disturbances (pulse \>110/min and systolic bp \<100)

Exclusion Criteria:

* Suspected to have an ectopic pregnancy
* Unable to provide informed consent
Tailored Internet Information Supply for Patients - Part 2

Medical expert systems in combination with portal searching meta-search engines are exploited to provide reliable patient-tailored information. A prototype of a web-based information system has been developed and is to be evaluated. Its aim is to answer the decisive question whether expert system guided internet meta-search provides a better information supply for patients seeking health information online then this is possible by using ordinary search engines or health portals. The research does neither investigate the influence of ethical nor legal aspects of internet health information supply.

The study is a follow-up of NCT00746408. It has been conducted because for the first study still not enough participants have been recruited. The study took part at Bamberg University in Germany with 140 participants.

Eligibility Criteria:
Inclusion Criteria:

* can use a computer
* can surf the internet

Exclusion Criteria:

* is a medical expert
A Study of ZN-c3 in Combination With Gemcitabine in Subjects With Osteosarcoma

This is a phase 1/2 study of ZN-c3 in combination with gemcitabine in adult and pediatric subjects with relapsed or refractory osteosarcoma.

This is a phase 1/2 dose escalation and dose expansion study, evaluating the clinical activity and safety, pharmacodynamics, and pharmacokinetics of ZN-c3 in combination with gemcitabine in relapsed or refractory osteosarcoma.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 12 years at the time of informed consent
* Bodyweight ≥ 40 kg
* Histologically documented relapsed or metastatic osteosarcoma.
* Must have measurable disease according to RECIST Guideline version 1.1 criteria.
* Adequate hematologic and organ function.
* Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception per institutional standard prior to the first dose and for 6 months after study treatment discontinuation.
* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Unresolved toxicity of Grade \>1 attributed to prior therapies (excluding: Grade ≤2 neuropathy, alopecia, or skin pigmentation)
* Prior therapy with a WEE1 inhibitor
* A serious illness or medical condition(s).
* Pregnant or lactating females. Females of childbearing potential with a positive serum pregnancy test \<14 days to Day 1.
* Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
* 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of \>470 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid.
* History or current evidence of congenital or family history of long QT syndrome or Torsades de Pointes (TdP).
* Taking medications with a known risk of TdP.
* Administration of strong and moderate CYP3A4 inhibitors/inducers and strong and moderate P-gp inhibitors.
Amulet™ ADVANCE LAA

This is a prospective, multicenter, observational study intended to characterize real-world outcomes on the commercially available Amulet device in the United States. Over 600 subjects have been enrolled at 16 US clinical sites. Subjects will be followed through 24 months in accordance with each site's standard care practices.

The ADVANCE LAA study is intended to characterize real-world outcomes of patients receiving the commercially available Amulet device in the United States. The Amulet device is intended to reduce the risk of thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular atrial fibrillation (NVAF) and who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short-term anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, taking into consideration the safety and effectiveness of the device.

Eligibility Criteria:
Inclusion Criteria:

* Intended for LAAO with the Amulet device
* At least 18 years of age
* Willing and capable of providing informed consent and participating in all testing associated with this clinical study

Exclusion Criteria:

* Presence of other conditions that, in the investigator's opinion, could limit the subject's ability to participate in follow-up
Choice Architecture and Mailed Colorectal Cancer Screening Outreach in a Community Health Setting

This is a 3-arm randomized trial aimed at increasing rates of participation in colorectal cancer (CRC) screening by outreach to patients' homes using choice architecture informed by behavioral science principles.

The investigators will evaluate the effectiveness of mailed outreach with choice between colonoscopy and FIT, and FIT alone, as compared to colonoscopy alone in increasing CRC screening rates.

Eligibility Criteria:
Inclusion Criteria:

1. At least 1 visit with CHDC in the past 2 years
2. Not up to date on CRC screening (no evidence of colonoscopy in the last 10 years, sigmoidoscopy in the last 5 years, or stool testing in the past 12 months)

Exclusion Criteria:

1. History of CRC or polyps
2. Significant family history of CRC
3. History of Inflammatory Bowel Disease or Ulcerative Colitis
4. History of colectomy
5. History of metastatic cancer
6. Current use of Medication Assisted Therapy (MAT)
Web-based Guided Self-help CBT-E vs Online G-CBT-E for Binge Eating Behavior

Eating disorders with binge eating as the core feature include bulimia nervosa (BN) and binge eating disorder (BED). In recent years, the prevalence rate has increased rapidly, mostly among women, accompanied by emotional problems, physiological complications and increased risks of obesity and depression, which bring great pain to patients. Enhanced Cognitive Behavioral therapy (CBT-E) for eating disorders is an evidence-based and effective first-line psychotherapy for BN and BED. CBT-E is implemented in various forms. In addition to face-to-face therapy, online group CBT-E and guided self-help CBT-E can significantly reduce binge eating in BN and BED patients. However, there are no relevant clinical studies in China. Since 2008, the applicant has carried out CBT treatment and research on eating disorders, translated and published the self-help book "Overcoming Overeating", and accumulated rich clinical research experience. This study intends to establish a set of CBT-E self-help therapy courses suitable for Chinese binge eating patients, and conduct a randomized controlled study of web-based guided self-help CBT-E and online group CBT-E to compare the effectiveness of the treatment modalities in the treatment of binge eating and the feasibility of online guided self-help CBT-E and online group CBT-E in the treatment of binge eating.


Eligibility Criteria:
Inclusion Criteria:

* Han nationality, aged 18-35 years old;
* Students with junior high school education or above;
* Meet the diagnostic criteria of BN or BED in DSM-5, body mass index (BMI)≥18.5 kg/m2;
* no systematic nutritional treatment, psychiatric drug treatment or any form of psychological treatment was received within 1 month before enrollment;
* Each patient must understand the nature of this study and sign informed consent.

Exclusion Criteria:

* Persons meeting other DSM-5 diagnoses other than BN and BED, such as substance abuse/dependence, depression, bipolar disorder, anxiety disorder, obsessive-compulsive disorder, etc., persons at high risk of suicide, persons with strong destructive impulses or antisocial behaviors;
* The patient has severe primary or secondary physical disease or cognitive impairment, which makes the patient unable to complete the required symptom assessment and psychological tests;
* Have received systematic nutritional therapy, individual and group psychotherapy;
* Those who have taken neuroblockers, antidepressants, lithium salts, stimulants, antiepileptics and other psychotropic drugs within the past 1 month;
* Participation in this clinical trial was deemed inappropriate by the investigator for other reasons.
Prospective Post-market Evaluation of an Echogenic Catheter

Patients scheduled for mastectomy and suitable for paravertebral block will be randomized to one of 2 groups.

Group 1 will have the nerve block performed using a standard non-echogenic needle and catheter under ultrasound guidance. Group 2 will have the block performed using the control needle and an echogenic catheter, all under ultrasound (US) guidance.

The clinician will be blinded to the catheter type and will assess the quality of catheter visualisation of the US image during the procedure, along with adequacy of spread of local anesthetic. The primary outcome will be needle visibility, and secondary outcomes will be block success rate and block quality. An assessment of the patient's pain levels after the procedure will also be conducted.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo breast surgery requiring use of a peripheral nerve block catheter for establishing a paravertebral block
* Patients classified as ASA (American Society of Anesthesiologists) physical status I, II or III
* Patients at least 18 years old
* Patient is willing and able to provide informed consent for study participation
* Patient has a good understanding of written and verbal English

Exclusion Criteria:

* Patient with contraindications to regional anesthesia technique (e.g. allergy to local anesthetic or other medications used in study)
* Patient with known coagulopathy
* Patient whose target nerve cannot be seen with linear ultrasound probe in a pre-procedure scan. All patients who need a curvilinear probe to visualize the target nerve will be excluded from the study.
* Patients having mastectomy and immediate reconstruction
A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects

The objective of this study is to evaluate the safety and efficacy of BLI4900 as a bowel preparation prior to colonoscopy in adult patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
* 18 to 85 years of age (inclusive).
* If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, abstinent, or vasectomized spouse).
* Negative urine pregnancy test at screening, if applicable.
* In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study.

Exclusion Criteria:

* Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
* Subjects with ongoing severe, acute inflammatory bowel disease.
* Subjects who had previous significant gastrointestinal surgeries.
* Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
* Subjects with uncontrolled hypertension (systolic blood pressure \> 170 mmHg and diastolic blood pressure \> 100 mmHg).
* Subjects with severe renal insufficiency (GFR \< 30 mL/min/1.73m2).
* Subjects with known severe hepatic insufficiency (Child Pugh C).
* Subjects with cardiac insufficiency (NYHA Functional Classifications 3 or 4).
* Subjects undergoing insulin therapy for any indication.
* Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
* Subjects undergoing colonoscopy for foreign body removal and/or decompression.
* Subjects who are pregnant or lactating, or intending to become pregnant during the study.
* Subjects of childbearing potential who refuse a pregnancy test.
* Subjects allergic to any preparation components.
* Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
* Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.
* Subjects who withdraw consent before completion of Visit 1 procedures.
Non-inferiority of GSK Biologicals' DTPw-HBV/Hib Compared to Two Formulations of GSK Biologicals' DTPw-HBV/Hib

The purpose of this observer-blind study is to generate immunogenicity data with one formulation of GSK Biologicals' DTPw-HBV/Hib vaccine after the primary vaccination course and to demonstrate non-inferiority of this vaccine as compared to two formulations of GSK Biologicals' DTPw-HBV/Hib vaccine with respect to the anti-PRP antibody response. Additionally to assess the reactogenicity and safety of GSK Biologicals' DTPw-HBV/Hib vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female between, and including, 6 and 8 weeks of age at the time of the first vaccination.
* Written informed consent obtained from the parent or guardian of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Born after a gestation period of 36 to 42 weeks inclusive.
* Administration of one dose of hepatitis B vaccine at birth

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period with the exception of OPV.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose, (with the exception of OPV).
* Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
* Hepatitis B vaccine received after the first week of life.
* Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae or hepatitis B (except hepatitis B at birth).
* History of diphtheria, tetanus, pertussis, Haemophilus influenzae or hepatitis B diseases.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease at the time of enrolment.
* Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Efficacy and Safety Study of the Fixed-dose Combination of Olmesartan + Indapamide When Compared to the Isolated Drugs in the Treatment of Hypertension.

Phase III clinical trial, multicenter of non-inferiority, randomized, single-blind evaluation of fixed-dose combination of olmesartan + indapamide compared to the isolated drugs in the treatment of hypertension.

This study is designed for the treatment of essential hypertension. It is performed in participants of both sexes, over 18 years of age, who have essential hypertension with diastolic blood pressure between 90 mmHg and 110 mmHg.

The rationale for studying the fixed dose combination is the possibility to enhance compliance and simplify treatment.

Eligibility Criteria:
Inclusion Criteria:

* Have signed the informed consent form;
* Participants of both genders aged ≥ 18 years;
* Essential hypertension based on a Diastolic Blood Pressure (DBP) \> 90 mmHg and \< 110 mmHg;
* Patients with no treatment or on antihypertensive therapy taking up to two anti-hypertensives;
* Possibility of discontinuing previous antihypertensive medication during the washout period.

Exclusion Criteria:

* Essential hypertension based on a Diastolic Blood Pressure (DBP) ≥ 110mmHg and Systolic Blood Pressure (SBP) ≥ 180 mmHg;
* Secondary hypertension;
* Participants with Body Mass Index (BMI) \> 35 Kg/m2;
* Non-controlled types 1 and 2 diabetes mellitus (HbA1 \> 8,5%);
* Myocardial infarction, coronary surgery or coronary angioplasty with or without stent placement, in the last 6 months;
* Unstable angina;
* Participants with coronary heart disease taking beta-blockers;
* Clinically manifest heart failure;
* History of cardiac arrhythmia;
* Moderate and severe heart valve disease;
* Stroke or transient ischemic attack in the last 6 months;
* Chronic disease of any nature that contraindicates the participant's participation according to the investigator's judgment, in particular renal failure with glomerular filtration rate \< 45 ml/min, serum potassium levels ≥ 5,5 mEq/L or ≤ 3,5 mEq/L, hepatopathies, or SGOT, SGPT or bilirubin levels 3 times above the normal upper limit, and blood dyscrasias;
* Known allergies or contraindication to the use of the study medication components;
* Female participants who are pregnant, breastfeeding or who want to become pregnant;
* COVID-19 symptoms;
* Post COVID-19 syndrome with cardiovascular impairment;
* Subjects who have participated in other study within the 12 months prior to screening (unless benefit is justified by the researcher).
Role of AS-OCT in Assessment of Corneal Perforation

Assessment of healing of thin and perforated cornea after surgical treatment by anterior segment optical coherence tomography

* thin and perforated cornea (small perforation) is surgically treated by amniotic membrane graft and platelet rich plasma clot
* anterior segment optical coherence tomography is performed preoperative and 1 month postoperative to assess healing

Eligibility Criteria:
Inclusion Criteria:

* thin cornea about to perforate
* small corneal perforation

Exclusion Criteria:

* active infection
Registry of Acute Ischemic Stroke With Large- or Medium-vessel Occlusion

This study is designed to observe the treatment options in real-world clinical practice as well as the safety and efficacy of different treatment strategies.

LOMEVO is a prospective, multicenter, real-world registry lasting for 10 years. A total of 50000 patients with large- or medium-vessel occlusion will be enrolled at approximately 30 centers around China.

Eligibility Criteria:
Inclusion Criteria:

* The clinical diagnosis is acute ischemic stroke with large- or medium- vessel occlusion (the criteria followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018)
* Informed consent from the patient or surrogate

Exclusion Criteria:

* No additional exclusion criteria
Perioperative Intravenous Lidocaine Infusion for Patients Undergoing Laparoscopic and Open Pancreatectomies

The purpose of this study is to evaluate if a lidocaine infusion will provide benefit to pancreatectomy patients in regards to analgesia and return of bowel function.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients undergoing elective open or laparoscopic total pancreatectomies and pancreatoduodenectomies (i.e., Whipple procedure), and participating in the Enhanced Recovery Protocol (ERP) at Mayo Clinic in Florida.
* Age 18 - 80 years old
* American Society of Anesthesiologist (ASA) class I - III
* BMI \< 40
* Ability to understand and read English

Exclusion Criteria:

* Not able or willing to sign consent
* Intolerance or allergy to opioids, NSAIDS, acetaminophen, or amide-type local anesthetics (i.e., lidocaine).
* History of epilepsy or currently receiving treatment for seizures
* Severe hepatic insufficiency (Child-Pugh Score C)
* Renal insufficiency (creatinine clearance less than 30 mL/minute)
* Advance heart failure (NY Heart failure stage 3 or greater; Ejection function \<30%)
* Cardiac arrhythmias: 2nd and 3rd degree heart block, sick sinus syndrome, symptomatic bradyarrhythmias, Wolff-Parkinson-White (WPW) syndrome, or Stokes-Adams syndrome; Left bundle branch block or bifascicular block; Not to exclude patients the following conditions unless clinical circumstance dictate: Atrial fibrillation or atrial fluTter; Presence of Implantable Cardioverter Defibrillator (ICD), or pacemakers
* Patients on anti-arrhythmic therapy (i.e., digoxin, amiodarone, flecainide, lidocaine, sotalol, etc.). Not to exclude patients on beta blockers (i.e., metoprolol, atenolol, etc.) unless clinical circumstance dictate
* Patients with active psychiatric disorders or cognitive dysfunction
* Pregnancy or lactating
* Enucleation, central, and distal pancreatectomy
* Opioid tolerance (defined as consumption of greater than 30 mg of oxycodone per day)
Asthma in the Elderly: The Effect of Montelukast

This is a pilot study of the effect of montelukast in subjects with asthma who are 65 years old and older. Montelukast is a leukotriene receptor antagonist U.S. F.D.A. approved for the treatment of asthma in subjects who are 12 month old and older. This study is being done because there has been no placebo controlled study of montelukast focused on this group of patients. Elderly asthmatics have been mostly ignored in asthma studies. They are more likely to be underdiagnosed, undertreated, and hospitalized for asthma when compared to younger asthmatics. The pathophysiology of asthma in the elderly is typically different than in younger patients. This is a double-blind, placebo-controlled, crossover study. Investigators plan to enroll thirty subjects who have been diagnosed with asthma for at least one year, are non smoker, and did not smoke for more than 10 pack/year of tobacco products in their lifetime. After a run-in period of one week, the study subjects will take montelukast 10 mg orally for 8 weeks first and then placebo for 8 weeks, or vice versa. Primary objectives of this study are to evaluate the effect of montelukast on asthma symptoms assessed by daily symptom scores, the Asthma Control Test and the number of puffs of albuterol, and spirometric values (FEV1). Secondary objectives include studying whether montelukast affects peripheral blood eosinophils counts and serum IgE levels.


Eligibility Criteria:
Inclusion Criteria:

* Asthma diagnosed for at least one year;
* Able to swallow small capsules.

Exclusion Criteria:

* Tobacco smoking for more than 10/pack years;
* Previous adverse reaction to montelukast or other leukotriene inhibitor;
* History of hypereosinophilic disorder other than atopic disease;
* Treatment with montelukast within 4 weeks from randomization;
* Asthma exacerbation or treatment with prednisone/other systemic steroid within 4 weeks from randomization.