louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01350687: Pulmonary Hypertension Prevention in Hemodialysis
Official title: New Phosphore Binders in Prevention of Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Disease
Keywords: Calcium Phosphore
Renagel
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
First posted: 2011-05-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 40 patients on hemodialysis treated with Phosphore biders, non-calcium containig.

Brief summary: Pulmonary hypertension is a new complication described in hemodialysis patients. in the last year these patients were treated by calcium carbonate orally to control serum phosphor. Calcium phosphor deposits in pulmonary artery can explain this phenomena. The investigators want to investigate the new phosphor non calcium containing agents in hemodialysis patients and to measure the pulmonary pressure.

Detailed description: The investigators will measure pulmonary blood pressure before and after treatment with new phosphor binders, non calcium containing.

Eligibility criteria: Inclusion Criteria:

* Hemodialysis Patients without fistula

Exclusion Criteria:

* Heart Disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tiberias
country: Israel
facility: Poria Medical Center
Study officials:
affiliation: Poria medical Center
name: Farid Nakhoul, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT03398187: Cardiac Catheterization in the Management of Pediatric Cardiac Patients at A.U.C.H.
Official title: Cardiac Catheterization in the Management of Pediatric Cardiac Patients at Assiut University Children Hospital ( A Descriptive Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all cases admitted for cardiac catheterization for diagnosis or intervention at Assiut University Children Hospital

Brief summary: The aim of this study is to find out and record the indications for diagnostic catheterization as well as for interventional cardiac catheterization in A.U.C.H , and record the outcome in these cases.

Detailed description: Cardiac catheterization is of two types:

diagnostic and interventional . There has been recent advances in these procedures.There is an over 10y experience at the pediatric cardiology unit in assiut University Children Hospital ( A.U.C.H ) catheterization department. The procedure usually follows other investigations used for evaluation of the pediatric cardiac patients e.g. chest X-ray , ECG and echocardiography.

The role of cardiac catheterization may be in the diagnosis of congenital cardiac anomalies as well as in the follow up of repair of some cardiac anomalies . On the other hand, the indications for interventional cardiac catheterization may be repair of Atrial septal defect, Transposition of great arteries palliation with balloon septostomy ,blood vessel dilatation e.g. aortic stenosis and coarctation of the aorta . In addition Patent ductus arteriosus closure and others may be done by the interventional cardiac catheterization.

Eligibility criteria: Inclusion Criteria:

-all cases admitted for cardiac catheterization for diagnosis or intervention at Assiut University Children Hospital

Exclusion Criteria:

* cases not admitted for diagnostic or interventional cardiac catheterization

Primary outcomes:
measure: procedure time
timeFrame: duration of the cardiac catheterization procedure (1-4 hours depending on complexity of case)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01078987: Plasmapheresis for Nephrogenic Fibrosing Dermopathy (NFD)/Nephrogenic Systemic Fibrosis (NSF)
Official title: Use of Plasmapheresis for Nephrogenic Fibrosing Dermopathy (NFD)/Nephrogenic Systemic Fibrosis (NSF) and Understanding Its Etiology
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Nephrogenic Fibrosing Dermopathy
Nephrogenic Systemic Fibrosis
Keywords: Nephrogenic Fibrosing Dermopathy (NFD)
Nephrogenic Systemic Fibrosis (NSF)
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2010-03-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pathophysiology of nephrogenic fibrosing dermopathy (NFD)/nephrogenic systemic fibrosis (NSF).


Eligibility criteria: Inclusion Criteria:

* diagnosed with NFD/NSF following a kidney transplant
* diagnosed with NFD/NSF following a liver transplant
* NFD/NSF and who have not had a kidney or liver transplant
* diagnosed with NFD/NSF and who have not had a kidney or liver transplant

Primary outcomes:
measure: Improve elasticity of skin, including increased range of motion of compromised joints due to leathery skin
timeFrame: Assessed two weeks after each monthly course of plasmapheresis
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
affiliation: Loma Linda University Medical Center
name: Pedro Baron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01946087: Remote Ischemic Preconditioning Induces Myocardial RISK Signaling Pathway in Patients Undergoing Valvular Heart Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patients With Elective Aortic Valve Replacement
Keywords: Remote ischemic preconditioning
cardiac surgery
left ventricular hypertrophy
reperfusion injury salvage kinase
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-09-19
Enrollment: 79
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate whether RIPC protects the heart against ischemia reperfusion injury on the concentrically hypertrophied myocardium


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥20 years with severe degenerative AS presenting concentric remodeling of the LV, who were scheduled for AVR

Exclusion Criteria:

* diabetes mellitus,
* coronary stenosis ≥70%,
* renal failure (serum creatinine \> 2.0 mg/dL),
* upper arm peripheral vascular disease,
* LV ejection fraction \<50%

Primary outcomes:
measure: Serum levels of CK-MB and Tn-T
timeFrame: baseline
measure: Serum levels of CK-MB and Tn-T
timeFrame: 12-hour after surgery
measure: Serum levels of CK-MB and Tn-T
timeFrame: 24-hour after surgery
Secondary outcomes:
measure: Myocardial activation of protective signaling pathway
timeFrame: Before commencement of CPB
measure: Myocardial activation of protective signaling pathway
timeFrame: After taking off CPB
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT01470287: Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent (DTwP-Hib-Hep B) Vaccine in Infants 6-8 Weeks of Age
Official title: A Phase-III, Single Arm, Multi-Center, Open-Label Study to Assess the Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent Vaccine (DTwP-Hib-HepB Vaccine) When Administered to Indian Infants at 6, 10, and 14 Weeks of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Pertussis
Hepatitis B
Hemophilus Influenzae B
Keywords: Infants,
Immunogenicity,
Safety
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-11-11
Enrollment: 175
Sex: ALL
Minimum age (years): 42
Maximum age (years): 64
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will evaluate immunogenicity, safety and tolerability of fully liquid pentavalent vaccine (DTwP-Hib-HepB Vaccine) in infants 6-8 weeks of age.


Eligibility criteria: Inclusion Criteria:

1. Male and female subjects ≥ 42 days to ≤ 64 days of age.
2. Written informed consent obtained from either parents/ legal guardian after the nature of the study has been explained according to local regulatory requirements

Exclusion Criteria:

1. Subjects whose parents or legal guardians are unwilling or unable to give written informed consent to participate in the study.
2. History of previous immunization with a vaccine containing any of the 5 antigen components of investigational vaccine.
3. History of anaphylactic shock(immediate hypersensitivity reactions), urticaria or other allergic reactions after previous vaccination or known hypersensitivity to any vaccine component.
4. Administration of parenteral immunoglobulin preparation and/or blood products since birth.

Primary outcomes:
measure: Seroprotection rate one month after the last dose of vaccine administration
timeFrame: One month after last vaccination
Secondary outcomes:
measure: Seroprotection rate and GMCs one month after the last vaccine administration
timeFrame: One month after last vaccination
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Rajarajeshwari Medical College and Hospital
state: Karnataka
city: Pune
country: India
facility: Bharathi Vidyapeeth University
state: Maharashtra
city: Kolkatta
country: India
facility: Medical College Kolkata
state: West Bengal
Study officials:
References:
citation: Eregowda A, Lalwani S, Chatterjee S, Vakil H, Ahmed K, Costantini M, Lattanzi M. A phase III single arm, multicenter, open-label study to assess the immunogenicity and tolerability of a pentavalent DTwP-HepB-Hib vaccine in indian infants. Hum Vaccin Immunother. 2013 Sep;9(9):1903-9. doi: 10.4161/hv.25166. Epub 2013 Jun 19.
Clinical trial NCT02466087: Role of Magnesium Supplementation in the Treatment of Depression
Official title: Role of Magnesium Supplementation in the Treatment of Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Depression
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2015-06-09
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this project is to test the hypothesis that magnesium supplementation will decrease depressive symptoms in adults.

This study takes place over 12 consecutive weeks. While the investigators will follow the volunteers for the full 12 weeks volunteers will only take magnesium supplements for 6 consecutive weeks. Volunteers will be randomly assigned to start the supplement at week 1 or week 7. Volunteers will take two supplement two times a day for a total of 248 mg elemental magnesium daily in the form of magnesium chloride. This amount of magnesium is less than the tolerable upper limit of 350 mg per day. The supplements will be provided. Volunteers will be asked to maintain their normal diet for the 12 weeks of the study.

The primary outcome measure is the PHQ-9 questionnaire, a validated measure of depression. Secondary measures include the GAD-7 for Anxiety and side effects.


Eligibility criteria: Inclusion Criteria:

* All adults at least 18 years of age
* A Patient Health Questionnaire-9 (PHQ-9) score of greater or equal to 5 but less than 20
* People who are currently being treated for depression are still eligible to participate but their treatment must be stable (no changes in medication dose or brand and/or no changes in therapy regimen for at least 2 months).

Exclusion Criteria:

* Active delirium or dementia
* Medicinal treatment for bipolar disorder, personality disorder or schizophrenia,
* Glomerular Filtration Rate of less than 60
* Irritable Bowel Disease
* Inflammatory Bowel Disease
* GERD
* Gastritis
* Pregnant as reported by potential volunteer
* Myasthenia Gravis
* Planned elective surgery
* Currently taking

  * Long Term Antibiotics
  * Fluoroquinolone
  * Trientine or Penicillamine
  * Long Term Antivirals
  * Digoxin
  * Bisphosphonates
  * Eltrombopag
  * Opiods
  * Calcium Channel Blockers
  * Deferiprone
  * Doxercalciferol
* Unable or unwilling to stop taking a magnesium supplement

Primary outcomes:
measure: Patient Health Questionnaire-9
timeFrame: 12 weeks
Secondary outcomes:
measure: Generalized Anxiety Disorder 7 Item Questionnaire
timeFrame: 12 weeks
measure: Change in Headaches While Taking Supplements
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: Emily Tarleton, MS, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04884087: EMA of Substance Use in Homeless Youth
Official title: Ecological Momentary Assessment of Substance Use in Homeless Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 factorial design (fixed incentive model vs. prize-based model; random assessment 3x vs. 6x per day)
Primary purpose: OTHER

Brief summary: The proposed study will provide critical information on Ecological Momentary Assessment (EMA) design characteristics that promote retention in a vulnerable and under-represented population in research-youth experiencing homelessness. The study will use an EMA app to collect substance use, mood, craving, social surroundings, and trauma measures over a 14-day period in youth age 18-24 (n=40) recruited from Star House, a homeless youth drop-in center. Youth will be randomized in 2x2 factorial design (fixed incentive model vs. prize-based model; random assessment 3x vs. 6x per day).


Eligibility criteria: Inclusion Criteria:

* currently homeless, defined as lacking a fixed, regular, and adequate nighttime residence.
* report any of the following past-month frequencies of substance use (NIDA ASSIST screen) used in prior EMA studies: a) heavy episodic or "binge" drinking (≥4 drinks per day for women/≥5 drinks for men) ≥2 days per month ; b) marijuana use ≥2 days per week; or c) any illicit drug use.

Exclusion Criteria:

-

Primary outcomes:
measure: Length of Time
timeFrame: Baseline to end of trial (day 14)
measure: Percent Completion
timeFrame: Baseline to end of trial (day 14)
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Abigail Wexner Research Institute at Nationwide Children's Hospital
name: Laura Chavez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00821587: Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation
Official title: Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C
Keywords: Hepatitis C Post Liver Transplant
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2009-01-13
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of cyclosporine, an anti-rejection drug, on the clearance of the hepatitis C virus in liver transplant subjects being treated with peg-interferon and ribavirin.

Detailed description: This is a randomized, single-center controlled study comparing two different immunosuppression regimens (CsA and TAC) in patients with recurrent HCV after LT undergoing antiviral therapy for HCV.

Eligibility criteria: Inclusion Criteria:

* Males and females age 18 years and older
* HCV RNA positive by PCR after liver transplantation
* Elevated ALT at any time point after liver transplantation
* Protocol liver biopsy (standard of care) consistent with Stage greater than or equal to 2 of Ishak fibrosis score after liver transplantation
* Able to provide written informed consent
* Willing to practice acceptable birth control during the study period.

Exclusion Criteria:

* Decompensated Cirrhosis
* hemoglobin \< 12 g/dl
* WBC \< 3,500/cubic mm
* Platelets \< 75,000/cubic mm
* Human immunodeficiency virus infection
* Pregnancy
* Positive HbsAg
* History of coronary artery disease, history of seizure disorder, poorly controlled autoimmune conditions, thyroid dysfunction, diabetes mellitus, major psychosis, intolerance to previous interferon-based therapy other than anemia or neutropenia
* History of suicidal ideation or suicidal attempts
* Creatinine \> 2.0 mg/dl
* Severe non-hepatic illnesses

Primary outcomes:
measure: Number of Participants With Less Than 100 Hepatitis C Virus RNA Copies/mL
timeFrame: 6 months after completion of interferon based therapy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Roberto J Firpi-Morell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01401387: Pancreatic Enzyme Suppletion in Pancreatic Cancer
Official title: Exocrine Pancreatic Insufficiency in Pancreatic Cancer: Evaluating the Need and Efficacy of Pancreatic Enzyme Replacement Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Adenocarcinoma of the Pancreas
Normal Pancreatic Exocrine Function
Lead sponsor: Foundation for Liver Research
Sponsor class: OTHER
First posted: 2011-07-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of immediate pancreatic enzyme suppletion on the physical and mental health status and survival of patients who are diagnosed with pancreatic cancer and are highly likely to develop exocrine pancreatic insufficiency during their disease process.

Detailed description: Weight loss in cancer is caused by primary tumour effects and secondary effects (e.g. side effects of treatment, mechanical and intestinal obstruction). In pancreatic cancer, additional weight loss and malnutrition may be due to the development of exocrine pancreatic insufficiency (EPI). The presence of EPI in pancreatic cancer is frequently overlooked, because the focus of treatment is directed at possible surgery or chemotherapy and its potential side effects. Although studies have proven that pancreatic enzymes may prevent or decrease weight loss, they are seldom being prescribed.

Eligibility criteria: Inclusion Criteria:

* Adenocarcinoma of the pancreas (histologically confirmed)
* Normal exocrine pancreatic function (Fecal Elastase test \> 0.2 mg/g)
* Capable and willing to follow instructions given by the physician.

Exclusion Criteria:

* Other causes of fat malabsorption (celiac disease, IBD, and major gastrointestinal surgery).
* \< 18 years.

Primary outcomes:
measure: To evaluate if prescribing pancreatic enzymes in patients with pancreatic cancer leads to a decrease in weight loss.
timeFrame: every month during 6 months after inclusion
Secondary outcomes:
measure: improvement of the nutritional status
timeFrame: every three months
measure: quality-of-life
timeFrame: on a monthly base during 6 months after inclusion
measure: improvement of the nutritional status
timeFrame: every month during six months after inclusion
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Marco Bruno, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01128387: Trial of Panitumumab/Cisplatin/Fluorouracil Combined With Radiation in Esophageal Cancer
Official title: A Phase I/II Study of Panitumumab/Cisplatin/Fluorouracil Combined With Radiation Preoperatively for Patients With Locally Advanced Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Cancer
Keywords: esophageal cancer
Locally advanced esophageal cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2010-05-21
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Dose escalation study
Primary purpose: TREATMENT

Brief summary: The overall study objective is to evaluate the dose limiting toxicities and the recommended phase II dose of Panitumumab when combined with the standard of care treatment with cisplatin, fluorouracil and radiation in patients with locally advanced esophageal cancer. The investigators will also be assessing the ability of PET (Positron Emission Tomography) imaging to predict the degree of pathologic response.

All patients will have a pre-study FDG (F-18 Fluorodeoxyglucose) PET scan and will receive radiation therapy and chemotherapy over a 35 day period. 4-8 weeks post radiation and chemotherapy patients will be restaged with a PET/CT scan. It is anticipated that approximately 30 patients enrolled will undergo an esophagectomy which is considered standard of care post radiation and chemotherapy. The surgery will allow us to compare this study regimen to the historical standard of care (Cisplatin/fluorouracil chemotherapy with radiation therapy).


Eligibility criteria: Inclusion Criteria:

1. Locally Advanced Esophageal cancer (stages T1N1 or T2-4 any N)
2. Histology must be adenocarcinoma or squamous cell carcinoma
3. Must be surgical candidate based on evaluation by a thoracic surgeon
4. must have adequate organ function as defined by routine lab tests

Exclusion Criteria:

1. Insitu carcinoma
2. prior chemotherapy for esophageal cancer
3. Metastatic (stage IV disease)
4. Tumors \<5cm from the cricopharyngeus muscle, Tumors with \>75% of tumor located within the stomach
5. Active, uncontrolled cardiac disease
6. subjects with \>Grade 2 neuropathies. -

Primary outcomes:
measure: MTD of Panitumumab in Combination With Cisplatin/Fluorouracil and Radiation for Locally Advanced Esophageal Cancer Determined by Number of Participants Experiencing DLT
timeFrame: approximately 18 weeks
Secondary outcomes:
measure: Pathologic Response
timeFrame: 20 weeks.
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Mark A Ritter, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: