louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00160121: Efficacy and Safety of Fosrenol in Treating Elevated Serum Phosphate Levels in Adults With End Stage Renal Disease
Official title: A Phase IV, Open-Label, Multi-Center Trial Evaluating the Efficacy of Fosrenol Compared to Existing Therapy in Adults With End Stage Renal Disease Treated for Hyperphosphatemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Failure, Chronic
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test how well lanthanum carbonate reduces the pre-dialysis level of serum phosphorus in subjects undergoing dialysis due to end stage renal disease and to determine the patient and physician's satisfaction.


Eligibility criteria: Inclusion Criteria:

* Patients with ESRD who currently require treatment for hyperphosphatemia

Exclusion Criteria:

* Female patient who is pregnant or lactating
* Patient has used any investigational product within 30 days of screening

Primary outcomes:
measure: Pre-dialysis serum phosphorus levels at 12 weeks
timeFrame: Week 12
measure: Patient satisfaction questionnaire at 12 weeks
timeFrame: Week 12
measure: Physician satisfaction questionnaire at 12 weeks
timeFrame: Week 12
measure: Patient preference questionnaire at 12 weeks
timeFrame: Week 12
measure: Physician preference questionnaire at 12 weeks
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Wilson RJ, Keith MS, Preston P, Copley JB. The real-world dose-relativity of sevelamer hydrochloride and lanthanum carbonate monotherapy in patients with end-stage renal disease. Adv Ther. 2013 Dec;30(12):1100-10. doi: 10.1007/s12325-013-0077-5. Epub 2013 Dec 5.
citation: Keith MS, Wilson RJ, Preston P, Copley JB. Cost-minimization analysis of lanthanum carbonate versus sevelamer hydrochloride in US patients with end-stage renal disease. Clin Ther. 2014 Sep 1;36(9):1276-86. doi: 10.1016/j.clinthera.2014.06.036. Epub 2014 Jul 26.
Clinical trial NCT01573221: Stroke and PMSI (Medicalisation Information Systems Programm)
Official title: Stroke and PMSI Evaluation of the Sensitivity and Specificity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2012-04-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: hospitalized stroke

Brief summary: Evaluation of the sensitivity and specificity of PMSI to identify the burden of stroke in France,from 2500 cases


Eligibility criteria: Inclusion Criteria:

* diagnosis of stroke in the hospital activity board

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon
city: Grenoble
country: France
facility: CHU Grenoble
Study officials:
affiliation: Centre Hospitalier Universitaire Dijon
name: Maurice GIROUD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01579721: Prospective Randomized Study of SILS Versus CLS for Rectal Cancer
Official title: Prospective Randomized Study of Single Incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rectal Cancer
Adenocarcinoma
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2012-04-18
Enrollment: 40
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: Background: Single-port laparoscopic surgery is emerging as a method to improve morbidity and cosmetic benefits of conventional laparoscopic surgery and minimize the surgical trauma. However, the feasibility of this procedure in rectal surgery has not been determined yet. The aim of this study is to evaluate our initial experience using single port access in laparoscopic rectal surgery.

Design: randomized, prospective clinical study Patients: 40 patients


Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years of age.
* ASA I-III.
* Tumor-location: maximum 15 cm from the anal verge.
* No involvement of neighbouring organs.
* No distant metastasis.

Exclusion Criteria:

* Linguistic, physical or psychological barriers precluding oral and written consent.
* History of intestinal surgery (excl. appendectomy).

Primary outcomes:
measure: morbidity
timeFrame: 30 days
Secondary outcomes:
measure: immunology
timeFrame: 72 hours postoperatively
measure: postoperative outcome
timeFrame: 5 days postoperatively
measure: oncology
timeFrame: 30 days
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Department of Gastroentestinal Surgery, Hvidovre Hospital
Study officials:
References:
citation: Bulut O, Aslak KK, Levic K, Nielsen CB, Romer E, Sorensen S, Christensen IJ, Nielsen HJ. A randomized pilot study on single-port versus conventional laparoscopic rectal surgery: effects on postoperative pain and the stress response to surgery. Tech Coloproctol. 2015 Jan;19(1):11-22. doi: 10.1007/s10151-014-1237-6. Epub 2014 Nov 8.
Clinical trial NCT06511921: Effect of Biologic Therapy on Surgical Outcomes for Perforated Crohn's Patients
Official title: Early Versus Late Biologic Therapy for Post-operative Perforated Crohn's Disease Patients Diagnosed for the First Time
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Crohn Disease
Keywords: perforation
biologic therapy
ileostomy
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-07-22
Enrollment: 60
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: crohn's disease patients who present by intestinal perforation as the first presentation are hard to deal with. Surgical techniques as anastmosis or diversion stoma and active course of the disease may greatly affect the quality of life. In post-operative period, is the priority to avoid the post operative complications and to improve surgical outcomes or to stop active course of the disease and to induce remission?. So, those patients were classified into two groups. one group will receive biological therapy early post operative and the other group will receive it 2 or 3 months later after surgery and the investigators will compare results between the two groups.


Eligibility criteria: Inclusion Criteria:

* patients at or above 18 years old
* patients with perforated bowel diagnosed as Crohn's disease at presentation underwent surgery

Exclusion Criteria:

* patients less than 18 years old
* well known Crohn's disease patients on medical treatment
* associated bowel disease as malignancy and diverticulosis.

Primary outcomes:
measure: size of intra-abdominal fluids or collection
timeFrame: from the first post-operative day to 2 months postoperatively
measure: bowel function
timeFrame: from the first post-operative day to 2 months postoperatively
measure: fecal fistula
timeFrame: from the first post-operative day to 2 months postoperatively
measure: skin maceration
timeFrame: from the first post-operative day to 2 months postoperatively
measure: body weight
timeFrame: from the first post-operative day to 2 months postoperatively
measure: age
timeFrame: 2 hours before surgery
measure: sex
timeFrame: 2 hours before surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Hospitals
Study officials:
References:
Clinical trial NCT01257321: Risk Stratification of Post Tonsillectomy Respiratory Complications in the Pediatric Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post Tonsillectomy Respiratory Complications
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2010-12-09
Enrollment: 200
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children, suffering of obstructive sleep apnea, having their tonsills removed

Brief summary: Obstructive sleep apnea syndrome (OSAS) is the most common indication for tonsillectomy and adenoidectomy in young children. According to previous studies, as much as 8 to 20% of patients will develop post operative respiratory complications requiring medical intervention. The pre-operative risk factors that could predict respiratory complications retrospectively analyzed were young age, obesity and high preoperative apnea-hypopnea index. Despite the removal of obstructing lymphoid tissue, upper airway obstruction occurs on the first postoperative night in children with OSA. There is a debate regarding the post-operative duration and monitoring needed in children with OSA.

Hypothesis:

Pre-operative, operative and immediate post-operative parameters could predict post tonsillectomy respiratory complications.


Eligibility criteria: Inclusion Criteria:

1. Pediatric patient \< 14 years old
2. Obstructive sleep apnea according to polysomnography
3. Surgery: Tonsillectomy/Tonsillotomy

Exclusion Criteria:

1. Patient suffering from known respiratory disease

Primary outcomes:
measure: respiratory distress
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT00580021: Clinical Outcomes in Hereditary Cancer
Official title: Clinical Outcomes in Hereditary Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Cancer
Pancreatic Cancer
Keywords: Ashkenazi ancestry
mutations in BRCA1 or BRCA2
Breast Cancer
Pancreatic Cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects will be individuals with the disease of interest during the time period of interest who described their religious preference at the time of registration to be Jewish.

Brief summary: Compare the clinical characteristics and post-surgical outcomes (overall survival)of pancreatic cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 .

Compare the clinical characteristics and outcomes (time to progression) of breast cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 receiving paclitaxel chemotherapy for metastatic disease.

Detailed description: Compare the clinical characteristics and post-surgical outcomes (overall survival)of pancreatic cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 .

Compare the clinical characteristics and outcomes (time to progression) of breast cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 receiving paclitaxel chemotherapy for metastatic disease.

Eligibility criteria: Inclusion Criteria:

* Included in DB0363-03
* Jewish religious preference at registration
* Archival material available for testing
* Adequate post-surgical follow-up
* Jewish religious preference at registration
* Archival material available for testing
* Adequate follow-up to determine time to progression

Exclusion Criteria:

-Subjects will not be included in the analyses if a DNA sample cannot be obtained.

Primary outcomes:
measure: The overall objective of the protocol is to examine the hypothesis that hereditary cancers are distinct in clinical characteristics and outcome from those that arise in the absence of a known predisposition.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Mark Robson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02316821: The Phase II Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes; TSUBAKI Study
Official title: RTA 402 Phase 2 Clinical Trial (A Randomized, Double-blind, Placebo-controlled Clinical Trial in Patients With Chronic Kidney Disease and Type 2 Diabetes)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Type 2 Diabetes
Keywords: Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Complications
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Renal Insufficiency
Urologic Diseases
bardoxolone methyl
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-12-15
Enrollment: 216
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
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 assess the safety and efficacy of RTA 402 in chronic kidney disease (CKD) patients with type 2 diabetes in a double-blind, placebo-controlled study when this compound is administered once daily for 16 weeks in an intrapatient dose escalation design.


Eligibility criteria: Inclusion Criteria:

* CKD patients with type 2 diabetes mellitus
* Patients whose estimated GFR levels are eligible for this study
* Patients being treated with stable dose of angiotensin converting enzyme (ACE) inhibitors and/or angiotensin II receptor blocker (ARB) etc.

Exclusion Criteria:

* Patients with type 1 diabetes mellitus
* Patients with known non-diabetic renal disease
* Patients with a history of renal transplantation
* Patients with mean systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 90 mmHg
* Patients with Hemoglobin A1c \> 10%
* Patients with cardiovascular disease specified in the study protocol etc.

Primary outcomes:
measure: Safety: Number and types of adverse events
timeFrame: Up to 16 weeks
measure: Change in glomerular filtration rate (GFR) measured by inulin clearance after 16 weeks of study drug administration, compared to baseline GFR
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Change in estimated GFR (eGFR) after 16 weeks of study drug administration, compared to baseline eGFR
timeFrame: Up to 16 weeks
measure: Profiles of pharmacokinetics of plasma RTA 402 concentration: Trough (Pre-dose) and peak (2-4 hours post dose) concentrations of study drug at steady state
timeFrame: Baseline, week 2, 6, 10, and 4 weeks after completion of study treatment
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
References:
Clinical trial NCT02342821: Empowering Immigrants in the Greater Boston Area to Connect to HBV Care
Official title: Empowering Immigrants in the Greater Boston Area to Connect to HBV Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2015-01-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: immigrants and other persons at HBV risk in Greater Boston area

Brief summary: This Study will attempt to provide information / linkage to HBV care for persons at risk in the Greater Boston area.

Detailed description: Specific Aims

1. Provide HBV education at community sites where immigrants at risk for HBV could be informed of the risks related to HBV, in a culturally and linguistically sensitive manner.

   1. Chelsea, Charlestown, and Revere MGH Community Health Centers: posters, pamphlets, and telephone line to provide HBV education
   2. Senegalese Community Center: community meeting, posters, and pamphlets
   3. African Students' Association, Suffolk University: community meeting, posters, and pamphlets
   4. Revere Cambodian Community Centers: community meeting, posters, and pamphlets
2. Provide at-risk persons with the tools to develop an HBV diagnosis plan with his / her provider.

   1. Provide counseling on the significance of different testing results prior to testing
   2. Connect to testing, and appropriate post-test follow-up appointments
3. Provide an education hub for patients and providers to return to with questions regarding: test interpretation, available treatments for those who test positive, and screening for hepatocellular carcinoma in those who are infected.

   1. Provide copy of an easy to understand US HBV treatment algorithm in native languages
   2. Provide information related to genotype-specific risks for HCC (increased with GT C).

Eligibility criteria: Inclusion Criteria: all persons interested in hearing more information about HBV -

Exclusion Criteria: children

-

Primary outcomes:
measure: Improved understanding of HBV by Questionnaire
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01023321: First-in-Human Single Ascending and Multiple Dose of GLPG0555
Official title: Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending and Multiple Oral Doses of GLPG0555 in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Tolerability
Pharmacokinetics
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2009-12-02
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral dose of GLPG0555 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG555 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.


Eligibility criteria: Inclusion Criteria:

* healthy male, age 18-50 years
* BMI between 18-30 kg/m², inclusive.

Exclusion Criteria:

* significantly abnormal platelet function or coagulopathy
* smoking
* drug or alcohol abuse

Primary outcomes:
measure: Safety and tolerability of single and multiple dosing
timeFrame: up to 10 days postdose
Secondary outcomes:
measure: Pharmacokinetics of single and repeated doses, including effect of food.
timeFrame: up to 10 days postdose
measure: To characterize the in/ex vivo pharmacodynamics (PD) of GLPG0555 after single and repeated oral administration
timeFrame: up to 72 hours postdose
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS Stuivenberg
Study officials:
affiliation: Galapagos NV
name: Gerben van 't Klooster, PhD
role: STUDY_DIRECTOR
affiliation: SGS Stuivenberg
name: Wouter Haazen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01928121: Effectiveness of an Interdisciplinary, Nurse-coordinated Atrial Fibrillation Expert Program for Primary Care Patients
Official title: Effectiveness of an Interdisciplinary, Nurse-coordinated Atrial Fibrillation Expert Program for Primary Care Patients - A Clustered Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: nurse
expert program
primary care
implementation
interdisciplinary
effectiveness
disease management system
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-08-23
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to assess the effectiveness of a newly developed interdisciplinary nurse-coordinated AF expert program for primary care patients. Therefore a prospective, pragmatic clustered randomized controlled trial will be performed in general practices.


Eligibility criteria: Inclusion Criteria:

* Every newly diagnosed AF patient.
* Every AF patient who is not seen by a cardiologist or electrophysiologist in the past 2 years before inclusion.
* AF must be confirmed on electrocardiogram.
* Capable of providing written informed consent.
* Dutch speaking and verbally testable, without cognitive impairment.

Exclusion Criteria:

* AF patients who once received an arrhythmologic consult about AF prior to the start of the study.
* AF patients who have a systematic follow-up at a cardiologist prior to the start of the study.
* Terminally ill AF patients
* Participation in another clinical trial

Primary outcomes:
measure: cardiovascular events
timeFrame: after 1 year
Secondary outcomes:
measure: Guideline adherence
timeFrame: after 1 year
measure: Hospitalization days and clinic visits
timeFrame: after 1 year
measure: Perceived health
timeFrame: After 1 year
measure: AF related symptoms and symptom burden
timeFrame: After 1 year
measure: Patient satisfaction
timeFrame: After year
measure: Patient knowledge
timeFrame: After 1 year
measure: Patient adherence with medication
timeFrame: After 1 year
measure: Time to establishment of a management plan by electrophysiologist or cardiologist
timeFrame: After 1 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams Brabant
Study officials:
References: