cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study for Inactivated Vaccine Against EV71

This study aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine in health children and infants aged from 2 months to \<12yrs.


Eligibility Criteria:
Main Inclusion Criteria:

1. Healthy children and infants aged from 2 months to less than 12 years as established by medical history and clinical examination
2. The subjects' guardians are able to understand and sign the informed consent

Main Exclusion Criteria:

1. Subject with previous known exposure to EV71.
2. Subject with a history of herpangina or hand, foot and mouth disease associated with enterovirus infection in the past 3 months.
3. Subject who was diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder.
4. Use of any investigational/non-registered product (including drug, vaccine and invasive medical device) within 30 days prior to vaccination or planned use during study period.
5. Subject with any confirmed or suspected autoimmune disorder, or immunodeficiency
6. Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the whole study period.
Colchicine for Patients With Chagas´ Disease( B1 Stage)

This study evaluate the addition of colchicine in the treatment of patients with Chagas´disease.

Forty patients will receive colchicine while twenty patients will receive placebo

Chagas disease is considered one of the main cause of dilated cardiomyopathy in Latin America. The histopathological characteristics of Chagas' disease are the presence of myocarditis, destruction of heart fibers, and severe myocardial fibrosis. Colchicine had a protective effect on myocardium, indicated by decreased interstitial myocardial fibrosis and attenuated myocardial inflammation. It is an inflammatory cause of cardiomyopathy and myocardial fibrosis is the hallmark of this disease. Colchicine is a drug used in inflammatory diseases, and could also act on myocardial remodeling interfering in the synthesis of collagen

Eligibility Criteria:
Inclusion Criteria:

* Clinical and serological diagnosis of Chagas´disease ( Stage B1)
* Must be able to swallow tablets

Exclusion Criteria:

* myocardial infarction or coronary artery disease,
* diabetes mellitus,
* valvular disease,
* creatinine clearance \<30 ml / kg / min
* contraindication to perform cardiac magnetic resonance imaging
* use of angiotensin converting enzyme inhibitors, angiotensin II receptor blockers and aldosterone blockers
* previous use of benzonidazole
2-Chlorodeoxyadenosine and Cytarabine in Patients With Idiopathic Hypereosinophilic Syndrome (HES)

Primary Objectives:

1. To determine the response rate, progression-free survival (PFS) and overall survival of patients who receive 2-CdA + Ara-C.
2. To examine if there is any clonality in the cytokine expression of helper T cells or cytokine receptor expression of eosinophils.
3. To determine the effect of 2-CdA on accumulation of Ara-C triphosphate in eosinophils.

Before the study begins, patients will have a physical exam, blood tests, and urine tests. Women will have a pregnancy test. A bone marrow sample will be taken. This is done with a large needle. Heart tests and an MRI scan of the brain will be done if there is a suspicion of disease in the heart or central nervous system.

Patients in this study must have a catheter (thin tube) placed in a vein in the arm or under the collarbone. This tube will be left in place throughout the study. 2-CdA (Cladribine) will be given through the catheter 24 hours a day on days 2 to 6. Ara-C (Cytarabine) will be given through the catheter over 2 hours on days 1, 3, 4, 5, and 6. Starting on day 9, patients will inject G-CSF under their skin once a day; G-CSF helps blood counts return to normal. Treatment will be given on an inpatient or outpatient basis. The first course is normally done inpatient.

During the study, patients will have blood tests daily during the first week and every other day after that. Bone marrow samples will be taken on days 14, 21, and 28. Further bone marrow samples may be necessary to evaluate response. Heart tests and MRI scans of the brain may be done.

This is an investigational study. G-CSF, 2-CdA, and Cytarabine are approved by the FDA for treatment of cancer. Up to 40 patients will take part in this study. Patients will be treated at M. D. Anderson or other centers. A total of 40 people will take part in this study. About 1 patient every 3 months will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Patient must have diagnosis of idiopathic HES, defined as (1) no recent history of allergic reaction or parasitic infection; (2) sustained (\> 6 months) hypereosinophilia (1,500/mm\^3); and (3) signs or symptoms of organ involvement.
2. Age less than 76 years old.
3. Patient is not pregnant.
4. Zubrod performance status \< 3.
5. Life expectancy is not severely limited by concomitant illness.
6. Serum creatinine \< 2 mg/dL.
7. Serum bilirubin \< 2 times upper limit of normal (2 mg/dL).
8. Alanine aminotransferase (SGPT) \< 2 times upper limit of normal (112 IU/L).
9. Participant has completed the informed consent process, understands the investigational nature of the study, agrees to participate, and has signed the informed consent.

Exclusion Criteria:

1. Evidence of chronic active hepatitis or cirrhosis, and \> 1 month from prior episode of hepatitis.
2. Presence of an active infection.
3. HIV positive.
4. Has eosinophilic leukemia (defined by presence of clonal cytogenetic abnormalities).
5. Recent history of parasite infection.
6. Recent history of allergic reaction.
Inflammasome Activation and Cortisol Metabolism in Obese Women With Recurrent Miscarriage

The prevalence of obesity among women of reproductive age is increasing. Obesity represents a chronic low-grade inflammatory state and NLRP3 inflammasome plays a pivotal role in obesity-induced inflammation. Obesity is associated with an increased risk of recurrent miscarriage (RM), but the underlying mechanisms are unclear. Abnormal inflammasome activation was also identified in the endometrium of women who experienced RM. Given inflammasome activation has emerged as common pathophysiology in obesity-related disorder and RM, the investigators wonder whether inflammasome activation occurs in the uterine macrophages of obese women, and result in early reproductive failure.

pending

Eligibility Criteria:
Inclusion Criteria:

All women have conceived naturally without the aid of assisted reproductive technologies

Exclusion Criteria:

N/A
Effect of a Decision Aid About Statin Use in Patients With Type 2 Diabetes Mellitus

Background- Statins are a safe and effective therapy to reduce cardiovascular risk in patients with type 2 diabetes; however some patients are not prescribed statins, others do not take it even after being prescribed, and others stop therapy prematurely. Lack of knowledge or misinformation about statins may be responsible for inadequate statin use.

Objective- To test the hypothesis that a formal, structured decision aid could correct deficiencies in the current decision-making process, increase statin use, and improve outcomes in patients with type 2 diabetes.

Methods - The investigators will develop a decision aid called STATIN CHOICE and will pilot its efficacy in a blinded randomized controlled trial enrolling 98 type 2 diabetes patients.

Outcomes- Primary outcomes: adherence to the decision to use or not to use statins three months after using STATIN CHOICE. Secondary outcomes: acceptability of STATIN CHOICE, knowledge about options, satisfaction with decisions, decisional conflict, encounter duration, and quality of life.

Expected results- The investigators anticipate that this work will yield an effective and innovative decision aid for statin use in type 2 diabetes patients. STATIN CHOICE, along with a detailed users manual, will be directly applicable in clinical practice. Data and experience from this project will inform the planning and conduct of a randomized multicenter trial of the effectiveness of STATIN CHOICE in diverse practice settings.

Significance- Patient participation in decision-making resulting in informed treatment decisions, as proposed in this study, will likely lead to improved quality of decision-making, more appropriate use of statins, and improved patient outcomes.


Eligibility Criteria:
Adult patients with type 2 diabetes attending a referral diabetes clinic, who are taking or not taking statins, and give consent to participate. Excluded were patients who had sensory or mental impairments or language barriers that preclude them from using the intervention and therefore participate in this trial.
Medical Treatment in Ectopic Tubal Pregnancy

Ectopic pregnancy (EP) is estimated to be responsible for approximately 20% of all pregnancy-related mortality and 46% early pregnancy mortality.1 Hemodynamically stable women with EP are frequently managed with methotrexate (MTX) while multiple protocols like fixed multiple doses, single-dose as well as two-dose regimens have been in practice for treating EP, but no consensus exists regarding the optimum dosage regimen.

Literature reports multiple dosage regimens of MTX to be associated with increased rates of side effects. Single dose protocol has good compliance and fewer side effects but is linked with lower success rates in comparison to multiple dose protocols.

A new treatment protocol involving "two-doses" of MTX for medical management of EP was introduced in 2007 but most of the research conducted so far has been retrospective in nature and limitations in study designs. No such study in recent years has been done in Pakistan to compare the success and safety of single-dose and two-dose MTX protocols so this study was planned to compare the success rates and safety of two-doses of MTX versus single dose of MTX in tubal EP.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of tubal ectopic pregnancy.
* Pre-treatment beta-human chorionic gonadotrophin (β-hCG) level below 1500 mIU/ml.
* Gestational sac with largest diameter as 4cm.
* Willing to take methotrexate treatment.
* Willing to follow up.

Exclusion Criteria:

* Heterotrophic pregnancy
* Persistent tubal pregnancy
* Embryonic cardiac motion
* Suspected tubal rupture
* Past history of harmful effects of methotrexate treatment on organ functions.
Effect on the Electrocardiographic QT Interval Corrected for Heart Rate (QTc) in Healthy Subjects

The purpose of this study is to determine the effect of BMS-708163 on the QTc interval (QT interval corrected for heart rate).


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) of 18 to 32 kg/m², inclusive.
* Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) and men, ages 18 to 55
* Healthy subjects

Exclusion Criteria:

* History of cardiac arrhythmias or palpitations associated with presyncope or syncope, or history of unexplained syncope
* Sexually active fertile men not using effective birth control (double barrier) if their partners are WOCBP
* Women who are pregnant or breastfeeding
* History of allergy or intolerance to moxifloxacin or any member of the quinolone class of antimicrobial agents
* History of hypokalemia, history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age
* Any clinically significant ECG abnormality
* History of seizure disorders
* History of drowning survival
Taping Technique With Supervised Exercises Protocol on Pain and Functional Status in Individuals With Arthritis

Osteoarthritis (OA) is claimed to be a global burden and a key health issue that affects the large weight-bearing joints of the lower extremity such as the knee and hip joints. The study was aimed to find out the efficacy of the tapping technique in addition to the supervised exercise protocol on pain intensity and functional status of an individual with patella-femoral arthritis.

The study was based on a controlled pretest-posttest experimental group design. After initial screening, forty individuals (mean age 55years, ranged 40-60years) with patello-femoral arthritis randomly (n=20each) assigned into two group A and B. Group A received taping technique in addition to the supervised exercises protocol while group B received supervised exercises protocol only. Both the groups received their specified treatment 5 consecutive days in a week for 4weeks. Data collected for the variables (VAS and WOMAC) at day1 pre-intervention (baseline) and at day 28th post-intervention. The t-test used for within and between group analysis with keeping the p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* The individuals with unilateral patella-femoral osteoarthritis
* Aged between 40-60years;
* Pain more than 3cm on VAS;
* Crepitus on movement,
* Showing osteophytes on standing skyline view of radiograph (Kallgren/Lawrence grade ≥2),
* found positive for the special tests (coordination test for the muscle vastus medialis, apprehension test for patellar, Clarke's test, and Waldron's test with phase I and II)

Exclusion Criteria:

* The individuals with involvement of tibio-femoral joint;
* Presence of patella alta/baja;
* History of rheumatoid arthritis/traumatic knee, knee surgeries within six months
* On steroid injection, neurological deficit, fragile skin around the knee, allergic to tape;
* Poor cooperation
Phase II, Randomized, Placebo-Controlled Study of ATI-7505 in Patients With Chronic Idiopathic Constipation

The purpose of this study is to determine whether ATI-7505 is effective in the treatment of chronic idiopathic constipation.

This study is designed to evaluate the safety and efficacy of ATI 7505 in generally healthy, adult patients who have had symptoms of chronic idiopathic constipation for at least 6 months as defined in the ROME III criteria.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* 18 and 75 years of age
* constipation symptom onset at least 6 months ago \& meet ROME III criteria for chronic constipation
* negative colonoscopy or air contrast barium enema within the past 2 years if ≥50 years of age or within the past 5 years if \<50 years of age;
* are able to refrain from use of medications known to treat constipation or associated symptoms throughout the study

Exclusion Criteria:

* transabdominal surgery, unstable coronary artery disease, organic gastrointestinal disease, collagen vascular disease, or any alarm symptoms within the 6 months prior to screening;
* taking prohibited medications (including laxatives, herbal remedies)
* participating in another drug or medical device study or use of any investigational drug within 30 days before dosing or planning to use prior to study completion;
* QTcB \>440 msec, abnormal 12-lead ECG, family history of sudden death at age \<40 years or history of long QT syndrome
* alcohol or drug abuse within the 6 months prior to screening;
* autonomic dyssynergic defecation
The Effects of 8 oz Fresh vs. Commercial Orange Juice on Blood Pressure In Normotensive Males Aged 18-59

The purpose of this graduate student research study is to determine the effects of drinking eight ounces of fresh vs. commercial orange juice on blood pressure in males with normal blood pressure.

Visit 1

-

Beginning of the first four weeks:

Upon arrival, subjects will be given a consent form to sign. The student investigators will go over the layoutof the research study such as the procedures, and compliance with them. Then, subjects will be asked if they agree with drinking orange juice daily for two months. If they agree, they will be asked to relax for five minutes, and the student investigators will take their blood pressure reading three times using a blood pressure monitor. The subjects will complete the Perceived Stress Scale (PSS) survey before leaving. The subject will drink orange juice for 28 days.

•

Visits 2, 3, and 4:

Subjects will meet with the student investigators at a convenient location. Subjects will be asked to rest for five minutes. Student investigators will then take their blood pressure reading three times using a blood pressure monitor. The subjects will complete the PSS survey before leaving.

•

Between visit 2 and 3:

There is a washout period of approximately eight weeks. • During the first and second set of the 4

-week intervention phase, subjects will visit student investigators to retrieve orange juice samples every 3 or 4 days.

Eligibility Criteria:
Inclusion Criteria: Healthy 18-59 years old males, willing to keep the same lifestyle, not taking any medications or antioxidant supplements to control blood pressure, and do not drink any types of orange juice within 30 days.

Exclusion Criteria: Diabetic, smoke cigarettes, marijuana or electronic cigarettes, drink alcohol more than one a week, allergic to oranges, and diagnosed as hypotensive or hypertensive.
Facilitating Skin-to-Skin Contact In the Postnatal Period

This study evaluates the safety and efficacy of a skin-to-skin facilitating garment used by mother-infant dyads. It has three phases including researcher observation, randomised controlled trialing and qualitative midwifery staff perspective. The research will determine the effect a facilitating garment has in comparison to conventionally facilitated skin-to-skin contact, by measuring its effect on the baby's temperature stability, breastfeeding status and weight velocity.

Skin-to-skin contact is used as part of a package of Kangaroo Mother Care across the world. This has been demonstrated to reduce neonatal morbidity, mortality, and inpatient stays for low birth weight and preterm infants (Charpak and Ruiz 2016).

This study examines the effect a facilitating garment, the Snuby® has on neonatal health outcomes associated with skin-to-skin contact, such as neonatal thermoregulation, breastfeeding status, and self-reported mother-infant bonding. It uses a mixed methods approach to address quantitative and qualitative outcomes including participant's perspectives, and measurable health markers.

Eligibility Criteria:
Maternal participants

Inclusion Criteria:

Women, non-binary and transgender participants. Aged 16+ years old. Vaginal birth, including ventouse, forceps and spontaneous vaginal birth. 28+ weeks pregnant. Body Mass Index of 18 to 30 inclusive. Births between 37 and 42 completed weeks of pregnancy. Women without any morbidities that will significantly impair their ability to independently parent their baby.

Women planning to give birth on the labour ward, co-located birth centre, standalone birth centre or at home.

Exclusion Criteria:

Caesarean section births. High dependency Unit patients. Illiterate in English. Multiple pregnancies e.g. twins. Registered child protection concerns. Substance misusing women. Body Mass Index of less than 18 at booking appointment. Body Mass Index of more than 30 at booking appointment. Aged under 16 years old.

Neonatal participants

Inclusion criteria:

Born 37 to 42 completed weeks gestation. Birth weight between 2500g and 4000g . Weight at six weeks of age less than 6000g. Neonates requiring blood glucose prefeed monitoring. From birth to six weeks of age.

Exclusion criteria:

Preterm neonates (less than 37 weeks gestation). Requirement for special or intensive neonatal care. Receiving phototherapy. Receiving intravenous antibiotics. Falling growth velocity of more than 2 centiles. Aged over 6 weeks old.

Midwifery staff participants

Inclusion Criteria:

Working at the National Health Service Trust hosting the research. Working through the Hospital Bank. Registered midwife through the Nursing and Midwifery Council. Working on band 5, 6 or 7. Working within the hospital setting.

Exclusion Criteria:

Midwifery staff working in the community without rotating to the hospital wards.
Detrusor Underactivity: Presentation and Urodynamic Characteristics

Detrusor underactivity (DU) is a known disease of the muscles of the urinary bladder that defined as a weak contraction of the muscle resulting in a failure to achieve complete bladder emptying. Recently, DU as a cause of Lower Urinary Tract Symptoms in both men and women has been increasingly gaining attention. There is a major issue in differentiation of underactive bladder symptoms and other causes of lower urinary tract symptoms such as detrusor hyperactivity and impaired contractility (DHIC), hypersensitive bladder (HSB), detrusor overactivity (DO), bladder outlet obstruction (BOO) and Dysfunctional Voiding (DV). Urodynamics (UDS) is the standard diagnostic tool, it includes invasive recording of the pressure that is produced when the bladder muscle contracts via pressure sensors introduced in the urinary bladder through special types of urethral catheters. This study aims to determine the prevalence of DU along with its symptomatic and urodynamics (UDS) characteristics of DU in Jordanian population through a retrospective chart review.


Eligibility Criteria:
Inclusion Criteria:

* Patients underwent UDS from July 2016 to August 2019

Exclusion Criteria:

* Patients with neurogenic bladder (NB) due to known underlying neurological disease, history of open pelvic surgery or major abdominal surgery, or using indwelling catheters or clean intermittent catheterization (CIC).
Tipifarnib and Radiation Therapy in Treating Patients With Unresectable Locally Advanced Pancreatic Cancer

RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and may make them more sensitive to radiation therapy. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving tipifarnib together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of tipifarnib when given together with radiation therapy in treating patients with unresectable locally advanced pancreatic cancer.

OBJECTIVES:

Primary

* Determine the maximum tolerated dose and dose-limiting toxic effects of tipifarnib when administered with radiotherapy in patients with unresectable locally advanced pancreatic cancer.

Secondary

* Determine the 3-month clinical response in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of tipifarnib.

Patients receive oral tipifarnib once or twice daily on weeks 1-8. Patients also undergo concurrent radiotherapy daily, 5 days a week, on weeks 2-8.

Cohorts of 3-6 patients receive escalating doses of tipifarnib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 1, 3, and 6 months.

PROJECTED ACCRUAL: A total of 8-18 patients will be accrued for this study within 12-15 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed pancreatic cancer

  * Locally advanced disease
* Unresectable disease requiring radiotherapy

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-2

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3

Hepatic

* AST or ALT \< grade 2 elevation
* Bilirubin ≤ 2.0 mg/dL\* NOTE: \*Prior biliary stent procedure to normalize bilirubin levels allowed

Renal

* Creatinine ≤ 1.5 times normal

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No peripheral neuropathy ≥ grade 2
* No known allergy to imidazole drugs, including any of the following:

  * Clotrimazole
  * Ketoconazole
  * Miconazole
  * Econazole
  * Fenticonazole
  * Isoconazole
  * Sulconazole
  * Tioconazole
  * Terconazole

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* At least 4 weeks since prior experimental or standard chemotherapy and recovered
* No concurrent experimental chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* No prior upper abdominal radiotherapy

Surgery

* Not specified