cyrilzakka/clinical-trials huggingface dataset:
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Endocrine Tumors of the Gastrointestinal Tract.

This 2 arm study will assess the efficacy and safety of two systemic treatments including Avastin in patients with previously-untreated progressive locally advanced/metastatic well-differentiated digestive endocrine tumors. Patients with duodeno-pancreatic tumors (arm 1) will be treated with 5FU/streptozotocin iv (5FU 400mg/m2/d D1 to D5;streptozotocin 500mg/m2/d/iv D1 to D5;D1=D42) every 6 weeks, plus Avastin 7.5mg/kg iv every 3 weeks. Patients with gastrointestinal tract tumors (arm 2) will be treated with Xeloda 1000mg/m2 po bid D1 to D14 plus Avastin 7.5mg/kg iv D1=D21 every 3 weeks. The patients will be treated with chemotherapy for a minimum of 6 months, unless there is tumor progression and/or unacceptable toxicity. The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* well-differentiated gastrointestinal tract endocrine tumors, or duodeno-pancreatic endocrine tumors;
* no previous anti-cancer therapy, other than surgery;
* progressive metastatic disease;
* \>=1 measurable lesion.

Exclusion Criteria:

* abnormal cardiac function, with history of ischemic heart disease in past 6 months and/or abnormal 12 lead ECG;
* patients with known bleeding disorders;
* unstable systemic disease;
* chronic daily treatment with high-dose aspirin, NSAIDs or corticosteroids;
* previous history of malignancy (other than successfully treated basal and squamous cell cancer of the skin, and/or in situ cancer of the cervix).
The Outcomes of Arteriovenous Fistula Cannulated From Different Direction.

The investigators hypothesis that aneurysms and stenoses will be decreased if the direction of inserted arterial needle were same as the direction of blood flow, when compared to the opposite direction puncture.

Native arteriovenous fistula (AVF) is the preferred access for hemodialysis, and cannulation technique is very important factors affect the outcomes of AVF. Rope-ladder cannulation is one kind of the standard puncture techniques which is used commonly in maintenance hemodialysis (MHD) patients. There are many complications for rope-ladder cannulation, such as venous aneurysm and vascular stenosis, which may induce AVF dysfunction. For the venous outflow way, there always be aneurysm followed by stenoses at the sites of needle connected with the arterial line in rope-ladder cannulation patients. The investigators hypothesis that the directions of inserted arterial needles should affect the AVF outcomes. The present prospective study will compare the outcomes of AVF between the puncture direction at arterial needle sites same as blood flow and opposite to blood flow.

Eligibility Criteria:
Inclusion Criteria:

* MHD patients with autogenous AVF.
* Newly setup AVF in 3 months.
* Fore- or Upper arm AVF.
* Flow of \>800ml/min detected by using the ultrasound dilution technique.

Exclusion Criteria:

* AVF after neoplasty.
* Arteriovenous grafts.
* Anticipated live time less than one year.
* Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.
Women and Child, Safety, Health, and Empowerment

Gender-based violence (GBV) (including homicide) is one of the leading causes of maternal and child (fetus, newborn or infant) mortality and morbidity in limited resource settings such as India. This study is evaluating the feasibility, acceptability and preliminary efficacy of WC-SHE (Women and Children-Safety, Health and Empowerment) intervention developed to promote health and safety outcomes of mother and children in rural and/or tribal regions in India. The aim will be to refine, optimize and standardize the WC-SHE intervention and its added components, develop fidelity measures, conduct a feasibility and acceptability evaluation of the intervention and implementation procedures as well as examine preliminary efficacy outcomes of WC-SHE.


Eligibility Criteria:
Inclusion Criteria:

1. Over 18 years of age
2. Currently pregnant
3. Experienced intimate partner and/or in-law abuse in the past
4. Residing in rural or tribal areas in India

Exclusion Criteria:

1. Under 18 years of age
2. Not currently pregnant
3. No experience of intimate partner and/or in law abuse
4. Not residing in rural or tribal areas in India
Mast Cell Connect: A Registry for Patients With Mastocytosis

The Mast Cell Connect Registry is a voluntary, observational database that will capture demographic, socioeconomic, and disease information directly from patients with mastocytosis via a secure web-based tool. No experimental intervention is involved.

Mastocytosis is an extremely rare and heterogeneous spectrum of diseases characterized by the buildup of genetically altered mast cells. Patients experience a wide range of symptoms and in some cases, mast cell buildup can lead to organ dysfunction and failure. Current treatments address disease symptoms and not the underlying cause. To facilitate the development of new therapies for mastocytosis, it is important for the community to support clinical trials and to document the impact of the disease, including disease natural history and the impact on patients, in a systematic way. Mast Cell Connect is a web-based registry that allows mastocytosis patients and caregivers to enter information about the experience of the patient living with mastocytosis directly into an online data collection tool.

The Mast Cell Connect Registry allows mastocytosis patients and caregivers to enter information about the experience of the patient living with mastocytosis directly into a web-based data collection tool. Two forms of data will be collected: responses to surveys administered on the web-based portal, and de-identified data curated from medical reports uploaded by patients or their caregivers.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with a diagnosis of mastocytosis, including systemic mastocytosis and cutaneous mastocytosis and any subtypes of these diseases, who is willing and able to provide written online informed consent

Exclusion Criteria:

* None
Clinical Efficacy of Remote Monitoring in the Management of Heart Failure

This is a clinical trial to evaluate the clinical benefit of remote monitoring in patients with heart failure having an ICD-CRT implanted.

Study purpose The purpose of this study is to test the hypothesis that the monitoring of specific clinical parameters, obtained by remote controls of ICD-CRT could improve clinical course of patients with heart failure.

Study design This is a prospective observational study, comparing clinical course of patients with heart failure having an ICD-CRT implanted, followed or not by remote monitoring. This study will include 870 subjects with ICD and CRT-D, and followed by a remote monitoring system (with or without weight and pressure external sensors) or followed by conventional ambulatory visits.

Primary endpoints The primary endpoint of this study is to document no superiority of unplanned hospital access for cardiac reasons (included access to the emergency units ) or death for cardiovascular causes in remote monitoring group (with or without weight and pressure external sensors) compared to conventional follow-up (usual care group).

Aim of the study The purpose of this study is to evaluate the clinical benefit of a dedicated remote monitoring system (RPM) in the management of patients with heart failure and implanted with ICDs and CRT-D.

The clinical benefit will be assessed by:

* Increased cardiovascular events (death, myocardial infarction, hospitalization).
* Events arrhythmia: atrial fibrillation, sustained and nonsustained ventricular tachycardia or ventricular fibrillation.
* Autonomic profile, echocardiographic parameters, 6-minute walk test, quality of life questionnaire.

The primary endpoint of this study is to estimate the incidence (and its accuracy) of the first event of unplanned hospitalizations for cardiac reasons or death from cardiovascular causes in the group monitored using RPM (with or without external sensors) and in the group management via conventional follow-up (Usual Care).

Eligibility Criteria:
Inclusion Criteria:

* Subjects \>18 years
* patients implanted or eligible for implant with ICD-CRT-D, accordingly with guidelines of the centers, for heart failure treatment and/or primary prevention of sudden death

Exclusion Criteria:

* Presence of clinically overt heart failure.
* Myocardial infarction within 2 months before enrolment.
* Significant concurrent illness or condition severely limiting life expectancy.
* Any surgical or medical condition which, at the discretion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period.
* History of drug or alcohol abuse within the last 2 years.
* Inability to communicate and comply with all study requirements including the unwillingness or inability to provide informed consent.
Molecular Surveillance of Artemisinin Resistance Malaria in Myanmar

Efficacy and safety of the artemisinin combination therapy (ACT) in uncomplicated falciparum malaria patients in Myanmar and artemisinin molecular markers analysis

The investigators assessed the efficacy and safety of the ACT in uncomplicated falciparum malaria in different sentinel sites in Myanmar. The recruited patients were follow-up until day 28 or day-42 based on the ACTs. Day-0 samples were analysed for artemisinin molecular markers, (K13 kelch propeller, Pfmdr2, Pffd and Pfarps10).

Eligibility Criteria:
Inclusion Criteria:

* Plasmodium falciparum mono infection by microscopy
* Presence of axillary equal to or more than 37.5 degrees centigrade or history of fever during the past 24 hours
* Ability to swallow oral medication
* Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule
* Informed consent from the patient or from a parent or guardian in the case of children

Exclusion Criteria:

* Presence of signs of severe falciparum malaria according to the definitions of World Health Organisation (WHO)
* Mixed or mono-infection with another Plasmodium species detected by microscopy
* Presence of severe malnutrition (defined as a child whose growth standard is below 3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference below 110 mm)
* Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, Human Immune Deficiency Virus (HIV)/Acquired Immune Deficiency Syndrom (AIDS)
* Regular medication, which may interfere with antimalarial pharmacokinetics
* History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s)
* A positive pregnancy test or breastfeeding
* Unable to or unwilling to take a pregnancy test or contraceptives
Effect of Yoga-based Exercises of Healthcare Workers During COVID-19 Pandemic: Prospective Clinical Trial

To investigate the effect of yoga-based exercises therapy on functional capacity, dyspnea, quality of life, depression, anxiety, and sleep quality in healthcare professionals following COVID-19.

Twenty-six healthcare professionals who were diagnosed with COVID-19, whose treatments were completed, and who were actively working during the subacute period with ongoing complaints were included in the study. The exercises program consisting of stretching, relaxation, isometric strengthening, breathing, and meditation exercises were given to the healthcare professionals under a 60-minute yoga-based exercises program held twice a week for a period of eight weeks. Flexibility and muscle strength measurements of the patients were calculated by the sit and reach test, shoulder flexibility test, and a hand dynamometer. Functional capacity was evaluated with the 6-minute walk test (6MWT), physical activity and dyspnea severity with the modified Medical Research Council (mMRC) dyspnea scale, depression and anxiety level with the Beck Depression and Anxiety Inventory, the quality of life with the SF-36, and sleep quality with the Pittsburgh Sleep Quality Index (PSQI).

Eligibility Criteria:
Inclusion Criteria:prospective clinical trial patients who were COVID-19 PCR (+) and/or diagnosed with COVID-19 pneumonia by computed tomography, completed their medical treatment, had ongoing fatigue, dyspnea, decreased stamina, difficulty in activities of daily living, anxiety, and depression complaints, had an event duration of 2 to 6 months, were actively working (between 25-60 years of age), and had a stable general condition and cognitive ability were included in our study.

Exclusion Criteria:Patients who were hemodynamically unstable, whose cardiac and pulmonary system stability could not be maintained, who had rheumatic, neurological, and psychological disorders, and those who could not continue the program due to working conditions were determined as exclusion criteria.
Bilateral Repetitive Transcranial Magnetic Stimulation for Auditory Hallucinations Results

The primary purpose of this study was to conduct fMRI neuroimaging studies prior to and subsequent to the rTMS intervention. The intent was to ascertain changes in regional brain activation and connectivity that most robustly predict level of improvement in auditory hallucinations elicited by bilateral rTMS as assessed by the primary outcome variables.

This study is an extension of previous clinical trials (NCT00308997 and NCT00567281) that were initiated in 2006. This study record provides the results for the amended study NCT00567281 (originally called a 'third arm') that was discontinued following the passing of Dr. Ralph Hoffman. The primary purpose of the study was to conduct fMRI neuroimaging studies prior to and subsequent to the rTMS intervention. The intent was to ascertain changes in regional brain activation and connectivity that most robustly predict level of improvement in auditory hallucinations elicited by bilateral rTMS as assessed by our primary outcome variables. It was hoped that this combined fMRI/rTMS study would provide critical new insights into the neurobiological basis of auditory hallucinations.

The results presented are what was summarized following Dr. Hoffman's passing and were compiled by Dr. Philip Corlett.

Eligibility Criteria:
Inclusion Criteria:

* Previously enrolled in our "parent" rTMS trial with passage of at least six months since last received active rTMS

Exclusion Criteria:

* Active substance abuse or alcohol abuse
* Pregnancy
* Dose or type of psychiatric medication changed within the 4 weeks prior to study entry
* Recent head trauma, seizures, or significant unstable medical condition
A Multiple Dose Study to Assess the Safety and Tolerability of BMS-963272 in Obese But Otherwise Healthy Adults

This study will assess the safety and tolerability of multiple doses of BMS-963272 in obese but otherwise healthy participants.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Participants must be in good general health, in the opinion of the investigator, with no clinically significant deviation from normal in medical history, physical examination findings, ECGs, or laboratory results.
* Participants must have a BMI of 30 kg/m2 to 40 kg/m2 inclusive
* Women (not of childbearing potential) and men aged 18 to 60 years, inclusive

Exclusion Criteria:

* Previous participation in the current study
* Inability or unwillingness to comply with protocol-defined restrictions or requirements regarding lifestyle, diet, concomitant medications, or other aspects of the study
* Inability to tolerate the oLTT meal or to comply with oLTT testing conditions
* Inability to tolerate oral medication
* Inability to tolerate venipuncture and/or inadequate venous access
* Women who are breastfeeding
* Medical Conditions
* History of lactose intolerance
* Any significant (in the opinion of the investigator) acute or chronic illness
* Type 1 or 2 diabetes
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
* Previous/Concomitant Therapy
* Previous exposure to BMS-963272

Other protocol-defined inclusion/exclusion criteria could apply
Monitoring Activity And Gait In Children

COHORT A: To study whether a digital health tool called Actigraph can be used to collect information on gait and physical activity in healthy children aged 3-17. The study will be conducted at the Pfizer Innovation Research Laboratory (PfIRe Lab) in Cambridge MA. In the lab at the first visit, we will ask participants to do activities such as walking on different surfaces as well as to roll a dice and move between different activity stations. Children will wear 2 Actigraph devices, one as a watch and one as a belt. They will then go home and do usual daily activities while answering a brief daily activity diary for approximately 2 weeks. The conclusion of the study will be over the telephone and include questions on the comfort and wearability of the device. The analysis of gait and physical activity as well as adherence and wearability will be looked across three different age groups 3-5, 6-11, and 12-17.

COHORT B: Cohort B of the study aims to evaluate the feasibility of the Panoramic Bracelet and associated algorithms such as SleepPy and GaitPy compared to the GENEActiv device and to evaluate the comfort and wearability of the Panoramic Bracelet. The results of this study will enable the use of novel devices in future clinical trials measuring scratch and sleep. . In the lab at the first visit, we will ask participants to do activities such as walking on different surfaces as well as to roll a dice and move between different activity stations. They will then go home and do usual daily activities while wearing both devices in the same wrist at different times stipulated in the protocol, answering a brief daily activity and sleep diary for approximately 2 weeks. Cohort B includes questions on the comfort and wearability of the Panoramic device on Day 7 approximately. The conclusion of the study will be over the telephone.The analysis will be looked across three different age groups 3-5, 6-11, and 12-17


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory
* No significant health problems that would impair the completion of the physical activity tasks, does not carry any diagnosis of developmental delay and/or significant co-morbid medical conditions as determined by a medically qualified individual during medical history review

Exclusion Criteria:

* Participation in other studies involving digital devices within 1 week and/or treatment with an investigational drug (Phases 1-4) within 30 days or 5 half-lives before the current study begins and/or during study participation.
* Participants with implanted medical devices.
* Minor participants who reach the age of majority during the study, as recognized under local law.
* Any medical or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Participants with known allergies to components as specified by device manufacturer if applicable (eg, plastic, stainless steel and silicone).
Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease

STA-5326 is an oral experimental drug that has been shown to block the release of interleukin-12 from peripheral blood mononuclear cells. Given this activity on the immune system, STA-5326 mesylate is a potential treatment for various autoimmune diseases, such as Crohn's disease, that are mediated by the inappropriate expression of Th1 cytokines.

This study is evaluating the use of STA-5326 mesylate in patients with moderate to severe, active Crohn's disease. Study visits include a screening visit, 4 treatment period visits over 4 weeks and a follow-up visit that will occur 7 days following the end of treatment. Subjects may continue treatment for an additional 4 weeks of open label STA-5326 mesylate administration that includes an additional 2 treatment period visits. Subjects will undergo a colonoscopy with biopsy collection at baseline, at the end of the 4 week blinded phase and at the end of the 4 week open label phase.


Eligibility Criteria:
Inclusion Criteria:

* Is male or female aged 18 through 75 years.
* Has Crohn's disease diagnosed definitively prior to Screening (based upon clinical, endoscopic, radiologic imaging, or histological assessments).
* Has a CDAI score of 220 to 450, inclusive at Baseline.

Exclusion Criteria:

* Has any clinically significant disease (eg, renal, hepatic, neurological, cardiovascular, pulmonary, endocrinologic, psychiatric, hematologic, urologic, or other acute or chronic illness) that in the opinion of the investigator would make the subject an unsuitable candidate for this study.
* Is a woman who has a positive pregnancy test, who is breast-feeding, or who is sexually active without using birth control during the course of the study and Follow-up period.
* Is a woman of childbearing potential or a man who does not agree to use 2 forms of contraception during the course of the study and Follow-up period.
* Has clinically significant hematologic, hepatic or renal laboratory abnormalities.
Guangdong Uptake of Surgery Trial

The purpose of this study is:

1. To determine whether an educational intervention designed based on studies in the area is effective in increasing acceptance of surgery and presentation to the hospital, when adjusting for a number of potential determinants of service uptake;
2. To assess short-term impact of the educational intervention on knowledge about cataract and attitudes toward locally-available surgical services.

China is home to the 18% of the world's blind people, an estimated 6.6 million. In China, cataract is the leading cause of blindness. In Guangdong, current counseling measures for patients diagnosed with cataract are minimal and often lack adequate descriptions of what cataract is, what causes cataract, and benefits/risks of surgery. A counseling session for cataract patients and family members, conducted by a trained nurse during outreach screening, may increase subsequent attendance at pre-operative examination, acceptance of cataract surgery, and attendance at follow-up examinations. An integral part of this counseling is a short movie consisting of testimony from a former cataract patient who underwent surgery ("pseudophakic motivator"). The use of pseudophakic motivators have been shown to be effective in increasing surgical uptake. In addition, a previously validated "Barriers Questionnaire" will be used to assess predictors of of hospital attendance, surgery acceptance, and follow-up attendance in the categories of cost, transportation, knowledge, and concerns about quality.

Eligibility Criteria:
Inclusion Criteria:

* thought by the examiner to have age-related or myopic cataract in one or both eyes
* pinhole-corrected visual acuity less than or equal to 6/18.

Exclusion Criteria:

* traumatic cataract
* inability to give informed consent due to dementia or other reasons.