cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets (0208-144)

This study will determine whether the CT formulation of famotidine taken with and without water is bioequivalent to the FCT formulation. The primary hypothesis is that the area under the concentration-time curve (AUC) and the maximum plasma concentration (Cmax) of a single dose of famotidine 20 mg CT without water are equivalent to a single dose of famotidine 20 mg FCT with water.


Eligibility Criteria:
Inclusion Criteria:

* Female participant is not pregnant or lactating
* Female of childbearing potential must use reliable means of contraception during the course of the study
* Is in good health
* Is able to abstain from smoking during the 24-hour periods before and during each treatment day

Exclusion Criteria:

* Has any major systemic disorders
* Has a history of ulcers, other Gastrointestinal (GI) disease, or GI surgery
* Has or has a history of any illness or condition that might interfere with optimal participation in the study
* Has a history of asthma or severe allergies to drugs or foods
* Currently uses prescribed or non-prescribed drugs on a regular basis
* Has a recent history of drug/alcohol abuse
* Consumes more than 6 cups of coffee per day
* Has unconventional or extreme dietary habits
* Has donated blood or has been in a clinical trial in which they received an investigational drug during the past 30 days
* Has a history of allergy or intolerance to antacids
* Is known to be pregnant or is not using reliable means of contraception
Perfusion Index as an Objective Measure for Supraclavicular Brachial Plexus Block in Pediatric Patients

The aim of the present study is to evaluate the effects of supraclavicular brachial plexus block using perfusion index in pediatric patients undergoing Upper limb surgery.

The role of perfusion index in the prediction of peripheral block success was previously reported for infraclavicular brachial plexus block, axillary brachial plexus block, interscalene brachial plexus block, and supraclavicular brachial plexus in adult patients. The aim of the present study is to assess the effects of perfusion index on success of supraclavicular brachial plexus block in pediatric patients.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II
* Children undergoing Upper limb surgery.
* Parents' agreement.

Exclusion Criteria:

* Parents' refusal.
* Children with behavioral changes
* Children with physical developmental delay
* Children on treatment with sedative or anticonvulsant.
Gleevec/Low-Dose Ara-C Study for Elderly Patients With AML and Myelodysplastic Syndromes

The goal of this clinical research study is to learn if the combination of Gleevec (imatinib mesylate) and low doses of Cytarabine (ara-C) may help to control leukemia while causing fewer side effects than standard high dose chemotherapy.

Imatinib mesylate is a drug that blocks a certain protein. This protein is thought to be important in the growth of leukemia cells. Ara-C is a chemotherapy drug that has been used for many years to treat AML and MDS.

Imatinib mesylate (Gleevec) is a protein-tyrosine kinase inhibitor that inhibits the Bcr-Abl tyrosine kinase, as well as the receptor tyrosine kinases for platelet- derived growth factor (PDGF) and stem cell factor (SCF), c-Kit, and inhibits PDGF- and SCF-mediated cellular events. c-Kit is expressed in over 90% of patients with AML.

The treatment of AML for patients age 65 or older with AML or high-risk MDS (age ³ 60 if high-risk cytogenetics) have a poor prognosis with induction chemotherapy. Response rate is no more than 45% with an induction mortality of at least 25%, and 1-year survival no better than 20%. Indeed, most patients in these age groups are not even offered therapy and are managed with supportive care only. Thus, new therapies that are better tolerated are needed.

Imatinib alone can induce response in nearly 20% of patients, and there is synergy with low concentrations of ara-C. In this study we plan to investigate the combination of imatinib and low-dose ara-C.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are not candidates for intensive chemotherapy with any of the following diagnosis: 1. AML or MDS (with \>/=5% blasts) age \>/= 65 years old (or age \>/= 60 if high-risk cytogenetics), or 2. AML or MDS (RAEB or RAEBT) of any cytogenetic group age 60 or older with minimally treated disease who have relapsed disease or are refractory to therapy and not likely to require cytoreductive therapy within one month, and, or 3. CMML.
* Patients with WHO performance status of 0 to 2
* Patients must have recovered from prior cytotoxic chemotherapy; treatment with hydrea is allowed up to 24 hours prior to day 1 of study drug administration
* Written informed consent obtained according to local guidelines
* Patients must have a serum creatinine of \</= 1.5 x ULN, SGPT \</= 3 x ULN and total bilirubin \</= 2.0 x ULN.
* Patients with \>/= 20% blasts positive for c-kit (CD117) (except for CMML)
* Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of childbearing potential must agree to employ an effective method of birth control throughout the study and for up to 3 months following discontinuation of study drug.

Exclusion Criteria:

* Patients with uncontrolled active infection
* Patients with NYHA class III or IV
* Women who are pregnant
* Women who are breast feeding
Shape Up! Adults Study

Identify the unique associations of body shape to body composition indices in a population that represents the variance of sex, age, BMI, and ethnicity found in the US population.

Describe the precision and accuracy of 3DO scans to monitor change in body composition and metabolic health interventions.

Estimate the level of association of 3DO to common health indicators including metabolic risk factors (glucose, triglycerides, HDL-cholesterol, blood pressure, VAT, WC and strength) by gender, race, age, and BMI.

Investigate holistic, high-resolution descriptors of 3D body shape as direct predictors of body composition and metabolic risk using statistical shape models and Latent Class Analysis.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants will be included in the study if they have a self-reported ability to:

  1. walk one-quarter of a mile and climb 10 steps without difficulty,
  2. perform activities of daily living (ADLs) without difficulty, and
  3. have no life-threatening conditions or diseases that would alter their body composition from what is typical for their age, sex, ethnicity, and BMI.

Exclusion Criteria:

* Participants will be excluded if they have any internal metal artifact (e.g. pacemakers, internal fixation, arthroplasty), amputation, physical impairment or previous fracture that would alter body composition assessment or are pregnant or breastfeeding.
* All premenopausal females will be asked for a spot urine sample for pregnancy test prior to participation.
* Those unwilling to comply with this will not be included.
A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)

This Phase 3 study will evaluate the efficacy and safety of KSI-301 compared to aflibercept, in participants with neovascular (wet) age-related macular degeneration (wAMD)

This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with visual impairment due to treatment-naïve neovascular (wet) age-related macular degeneration (wAMD)

The primary endpoint will be assessed as an average of Weeks 40, 44, and 48; additional secondary endpoints for efficacy will be assessed by visit over time

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to participation in the study.
* Treatment-naïve choroidal neovascularization (CNV) secondary to AMD.
* BCVA ETDRS score between 83 and 25 letters, inclusive, in the Study Eye.
* Decrease in vision in the Study Eye determined by the Investigator to be primarily the result of wAMD.
* Other protocol-specified inclusion criteria may apply

Exclusion Criteria:

* BCVA of hand motion or worse in the non-Study Eye or non-physical presence of a non-Study Eye (i.e., monocular).
* Active or suspected ocular or periocular infection or inflammation.
* CNV secondary to other causes in the Study Eye.
* Any history or evidence of a concurrent ocular condition present in the Study Eye, that in the opinion of the Investigator could require either medical or surgical intervention or affect macular edema or alter visual acuity during the study.
* Uncontrolled glaucoma in the Study Eye.
* Significant media opacities, including cataract, in the Study Eye that might interfere with visual acuity, assessment of safety, OCT or fundus photography.
* Cataract in the Study Eye that in the judgment of the Investigator is expected to require surgical extraction within 12 months of screening.
* Women who are pregnant or lactating or intending to become pregnant during the study.
* Recent history (within the 6 months prior to screening) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event.
* History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product.
* Uncontrolled blood pressure defined as a systolic value ≥180 mmHg or diastolic value ≥100 mmHg while at rest.
* Other protocol-specified exclusion criteria may apply
An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer

The purpose of this study is to learn how hereditary or sporadic medullary thyroid cancer patients, treated with ZD6474, react to the drug, what happens to ZD6474 in the human body, about the side effects of ZD6474, and if ZD6474 can decrease or prevent the growth of tumors.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic Medullary Thyroid Cancer.
* Presence of measurable tumor
* Able to swallow medication

Exclusion Criteria:

* Major surgery within 4 weeks before randomization
* Last dose of prior chemotherapy received less than 4 weeks prior to randomization
* Radiation therapy within the last 4 weeks prior to randomization(with exception of palliative radiotherapy)
* Brain metastases or spinal cord compression, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days
* Significant cardiac events
* Previous ZD6474 treatment
PreColo Practice Variation

This study will answer the question what the practice variation is (in terms of efficiency) in primary colon surgery on patients of 75 years and above related to the application of different modalities of prehabilitation across the Netherlands.

Rationale: Prehabilitation has shown promising results in orthopedic, cardiothoracic and abdominal surgery. However, there is still a lack of data supporting cost-effectiveness of prehabilitation in colon cancer surgery in older patients. Therefore the Dutch guidelines still restrict prehabilitation for research settings.

Objective: This study will answer the question what the practice variation is (in terms of efficiency) in primary colon surgery on patients of 75 years and above related to the application of different modalities of prehabilitation across the Netherlands. Besides, it will show what service factors (including prehabilitation) determine the technical efficiency of primary colon surgery for these patients of 75 years and above.

Study design: This study is a multicenter observational study based on questionnaires and existing data sources, aimed at including 24 different hospitals, of which structural, process and outcome data related to prehabilitation and colon cancer surgery will be registered.

Study population: Patients aged 75 years and above, 10 per participating hospital, who underwent colon cancer surgery in one of the participating hospitals, where prehabilitation is or is not applied. All patients will be followed with questionnaires focusing on process and outcome measures for the hospital period and three months after discharge.

Intervention: Whether or not the intervention (prehabilitation) is judged as part of daily practice in a participating hospital is based on a predefined definition of oncological surgical prehabilitation. The care as given in a participating hospital is according to the local guideline and will not be changed for this study. According to our definition prehabilitation consists at least of a minimum of 2 weeks exercise therapy and a review of the patients nutritional status at least 2 weeks before surgery.

Usual care: Guideline based colon cancer surgery, without prehabilitation. Main study endpoints: Technical efficiency and service factors that determine this technical efficiency of primary colon cancer surgery. The results will be presented anonymously both for patients and hospitals (so there will not be carried out benchmark analyses per center).

Statistical analysis: Data Envelopment Analysis will be carried out. Factors that might explain variability in technical efficiency will be regressed on bias corrected DEA scores (via truncated regression). Ethical considerations: There will be no change in standard procedures in everyday care. The burden for participants is minimal.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 75 years and above
* Scheduled for colon cancer surgery

Exclusion Criteria:

* Not receiving surgery
* Hematogenous metastasis
* Pretreatment; chemotherapy or radiotherapy
* Rectal cancer
Biosensors for Open and Closed-loop Glycemia Control in T1D Patients With Insulin Pump

In T1D, the destruction of beta-pancreatic cells causes insulin deficiency and requires insulin therapy whose control remains complex: even with recent technologies of continuous measurement and monitoring of blood glucose (CGM), current systems are electrochemical, insulin therapy algorithms do not are not optimal and cannot completely eliminate vital risks such as hypoglycemia. A new biosensor connected to the patient by microdialysis, will be tested in a clinical trial in CHU-Bdx on 10 T1D patients with an internal or external insulin pump. In various daily scenarios (meals, physical exercise) the biosensor DIABLO responses will be compared to the measurements of standard CGM systems.

Continuous monitoring and linked drug delivery is a novel approach to the treatment of chronic diseases that provides powerful means to improve therapeutic outcomes and quality of patient's life. Type 1 diabetes (T1D) concerns 5 to 10% of the estimated 415 million cases of diabetes worldwide in 2016, expected to rise to 642 million by 2040(1). Continuous glucose monitoring systems (CGMS) linked to insulin delivery has provided a major advance(2). T1D is a serious, currently chronic and costly disease in children or young adults. Indeed, the destruction of pancreatic beta-cells leads to absolute insulin deficiency in T1D.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Patient with type 1 diabetes (T1D)
* Patient being equipped and trained with an external or internan insulin pump linked to a CGM
* Affiliated person or beneficiary of a social security scheme
* Free, informed and written consent

Exclusion Criteria:

* Patient under 18 years
* Patient not having T2D
* Pregnant or lactating patient
* No consent signed by the patient
Retroperitoneal Tunneling Versus Dissection Technique During Sacrocolpopexy

The purpose of this study is to compare operative time, patient reported outcomes, surgical complications, and surgical outcomes between the tunneling versus dissection technique during robotic assisted sacrocolpopexy (RA SCP).

Women with symptomatic, stage II to IV POP who plan RA SCP at UTMB Health will be approached to participate. Using the study protocol inclusion and exclusion criteria, patient's eligibility will be determined. All eligible subjects will provide the written informed consent before any research data is collected. All screening assessments will be completed at a preoperative, in-person, clinic visit, and within 60 days of surgery. The subject will then undergo randomization to tunneling versus dissection technique during RA SCP with the total sample size of 40 female subjects (20 per group). Concomitant procedures for POP or urinary incontinence are permitted and will be based upon the operating surgeons' standard clinical practice and best clinical judgement. Subsequently, the subject will have postoperative follow up at 2 weeks, 6 weeks and 3 months

Eligibility Criteria:
Inclusion Criteria:

1. Females at least 18 years of age at the time of consent.
2. Able to understand and read English
3. Able and willing to provide written informed consent
4. Able to comply with the follow-up study protocol, per clinician judgment
5. Symptomatic POP (bulge or pressure) evidenced with vaginal prolapse with POP-Q measurement consistent with Stage II-IV.
6. RA SCP as desired surgical approach to correct apical prolapse

Exclusion Criteria:

1. Females who are pregnant, or intend to become pregnant during the study
2. Texas Department of Criminal Justice prisoners
3. A known history of sensitivity to propylene mesh
4. Prior prolapse repair surgery using mesh (abdominal, vaginal or rectal)
5. Active or chronic systemic infection including any pelvic infection, abscess
6. Has had history of primary pelvic organ cancer (uterine, ovarian, endometrial, cervical, bladder) or any cancer that is metastatic to the pelvis
7. Prior or current pelvic radiation, or chemotherapy.
8. Not a candidate for general anesthesia
9. History of systemic connective tissue or musculoskeletal disorders (scleroderma, SLE, Marfan's syndrome, Ehlers Danlos, polymyositis, Lambert Eaton syndrome etc)
10. History of neurologic condition affecting bladder function (multiple sclerosis, spinal cord injury, stroke with neurologic deficit)
Establishing the Central and Peripheral Fatigue Indexes and VR Based Anti-fatigue Training Paradigm for Individuals With Parkinson Disease

Fatigue is one of the most common symptoms in individuals with Parkinson's Disease (PD). Past researches indicated that more than half of the individuals with PD demonstrated fatigue symptom. The severity of fatigue was also correlated to the quality of life in individuals with PD. Finding the contributions of the central and the peripheral factors to fatigue, building reliable fatigue indexes, and developing an effective training program for individuals with PD are very important.

The purpose of this project is to develop non-invasive method to monitor central and peripheral fatigue, to establish Virtual Reality(VR) anti-fatigue ergo cycling training paradigm, and to evaluate the long term training effect in individuals with PD.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Parkinson disease
* Hoehn and Yahr ≦3

Exclusion Criteria:

* Musculoskeletal injuries
* Osteoporosis
* Diabetes
* Any peripheral or central nervous system injury or disease patients
A Clinical Trial Investigating the Safety and Efficacy of Subjects With Alcohol Associated Hepatitis (Part 1)

A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects with Moderate Alcohol Associated Hepatitis (Part 1)


Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 21 years old on the day of signing the informed consent form;
* Clinical diagnosis of alcoholic hepatitis, based on clinical features and laboratory testing, confirmed by the Investigator at screening
* Agreement to abstain from alcohol and utilize resources to cease at-risk behaviors during the trial, including addiction/alcohol abuse treatment
* Ability and willingness to swallow tablets
* Willingness to provide signed informed consent, prior to any trial-related procedures and willingness to comply with the trial procedures and requirements

Exclusion Criteria:

* Pregnant, intending to become pregnant (or father a child), or breastfeeding
* Current or recent enrollment in another interventional trial in the 30 days prior to screening
Preoperative Chemoradiation for Glioblastoma

Trial to determine the safety of neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.

Prior to any definitive treatment and after enrollment, the patient will undergo stereotactic biopsy of the lesion to confirm the histology of the lesion and to determine methylated methylguanine methyltransferase (MGMT) status. Standard image-guided stereotactic technique will be used. Patients will be treated with conformal radiation therapy. Temozolomide will be given from the day prior to radiation therapy through the last day of radiation therapy. 4-6 weeks after radiation therapy the patient will undergo craniotomy and maximal safe resection. Temozolomide will continue beginning 4 weeks after surgery.

Imaging:

MRI within 2 weeks prior to the start of the protocol. MRI at 4 weeks after chemoradiation therapy and prior to surgery. MRI within 48 hours after surgery.

MRI after every 2 cycles of chemotherapy and then every 2 months until progression, up to 2 years.

Eligibility Criteria:
Inclusion Criteria:

* MRI lesions of the brain that have a high probability of being glioblastoma in a potentially resectable location in the brain (the primary study population)
* WHO performance status 0-2 (to allow comparison to historical controls)
* Adequate hematological parameters: (for safety because of neutropenia from the temozolomide)
* Consent can be obtained from the patient, and if the patient cannot give consent then from the medical power of attorney and if one is not assigned, then the nearest relative (required to obtain consent)
* Able to have MRI scans (secondary endpoint is MRI scan characteristics)
* Willing to have radiation treatment at a participating center (homogeneity of treatment parameters)
* Ages 18-80

Exclusion Criteria:

* Unresectable tumor
* Absolute neutrophil count (ANC) less than 1,200/μL
* Hemoglobin less than 9.0g/dL
* Platelet count less than 100,000/μL