louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03364595: Operative Plate Fixation Versus Replacement for Mason Type III Fracture of Radial Head
Official title: Operative Plate Fixation Versus Replacement for Mason Type III Fracture of Radial Head
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Radial Head Fracture
Keywords: radial head fracture
replacement
plate
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men or women aged 18 to 65 years of age with Mason Type III radial head fracture

Brief summary: To compare the effect of Operative Plate Fixation Versus Replacement for Mason Type III Fracture of Radial Head

Detailed description: From April 2015 to October 2016, patients with comminuted radial head fractures diagnosed as Mason type III are retrospectively included in this study, they were treated with either operative plate or radial head replacement. All the patients are regularly followed up in clinic. Then we will compare the union rate and clinical functional outcome(Mayo score) between the 2 groups at 1 year after surgery.

Eligibility criteria: Inclusion Criteria:

Men or women aged 18 to 65 years of age with Mason Type III radial head fracture are confirmed by radiograph within 1 month post injury Provision of informed consent

Exclusion Criteria:

Pathological fractures Non-displaced (cortical contact) fractures Open fractures Presence of vascular or nerve injury Fractures more than 1 month post-injury Limited life expectancy due to significant medical co-morbidity Medical contraindication to surgery Inability to comply with rehabilitation or form completion Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)

Primary outcomes:
measure: Union rate
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Functional score
timeFrame: 1 year after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Peking University People's Hospital
name: Peixun Zhang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01309295: An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease in Pre-Dialysis or Dialysis
Official title: A Prospective Study Evaluating the Efficacy and Safety of Mircera in Patients With CKD in Predialysis and Dialysis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia, Kidney Disease, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-03-07
Enrollment: 250
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: Chronic kidney disease patients initiated on Mircera treatment

Brief summary: This prospective observational study will assess the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in clinical practice in patients with chronic kidney disease, in pre-dialysis or on dialysis, initiated on Mircera treatment. Data from each patient will be collected over 12 months of treatment.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Chronic kidney disease, in pre-dialysis or dialysis
* Appropriate for treatment with Mircera according to current guidelines and Summary of Product Characteristics

Exclusion Criteria:

* Anemia due to non-renal causes
* Pregnant or lactating women
* Uncontrolled hypertension
* Known hypersensitivity to methoxy polyethylene glycol-epoetin beta

Primary outcomes:
measure: Achievement of target hemoglobin (Hb) range of 10-12 g/dL according to Kidney Disease Outcomes Quality Initiative (KDQOI) guidelines
timeFrame: 2 years
measure: Maintenance of target Hb range (10-12 g/dL)
timeFrame: 2 years
measure: Safety: Incidence of adverse events
timeFrame: 2 years
Secondary outcomes:
measure: Correlation between baseline clinical variables and time on target Hb level
timeFrame: 2 years
measure: Dosing pattern in clinical practice, including dose adaptations
timeFrame: 2 years
measure: Frequency of visits and laboratory assessments
timeFrame: 2 years
measure: Effect of compliance to treatment on Hb levels
timeFrame: 2 years
Other outcomes:
Locations:
city: Tirane
country: Albania
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02817295: Bariatric Surgeries in Elderly
Official title: Bariatric Surgeries in Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery
Lead sponsor: Assuta Medical Center
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 9000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients underwent baritaric surgery

Brief summary: an examination of the different aspects of bariatric surgery in elderly in comparison with non-elderly patients.

Detailed description: the study examines the success rate, complications, revisions, days of hospitalization and co-morbidities in elderly and in non-elderly patients that underwent bariatric surgery in our medical center

Eligibility criteria: Inclusion Criteria:

bariatric surgery

Exclusion Criteria:

below 18 years old

Primary outcomes:
measure: Number of complications.
timeFrame: six months
measure: Number of revisions
timeFrame: six months
measure: Number of days of hospitalization
timeFrame: six months
measure: Incidence of co-morbidities
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Assuta Medical Center
Study officials:
References:
Clinical trial NCT01274195: Hematopoietic Stem Cell Transplantation With Targeted Busulfan and Fludarabine in Pediatric AML
Official title: Hematopoietic Stem Cell Transplantation With Targeted Busulfan and Fludarabine in Pediatric AML
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hematopoietic Stem Cell Transplantation
Keywords: Hematopoietic stem cell transplantation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-01-11
Enrollment: 27
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study we plan to improve the outcome of hematopoietic stem cell transplantation by using optimal busulfan dose through pharmacokinetic study.

Detailed description: Busulfan is a highly toxic drug with narrow therapeutic window used for the conditioning of hematopoietic stem cell transplantation. High exposure is associated with systemic toxicity such as veno-occlusive disease (VOD) and underexposure is associated with graft failure or relapse. In this study the investigators plan to improve the outcome of hematopoietic stem cell transplantation by using optimal busulfan dose through pharmacokinetic study.

Eligibility criteria: Inclusion Criteria:

1. Patients who are diagnosed as AML.
2. Patients who need hematopoietic stem cell transplantation with busulfan based conditioning regimen.
3. Age: up to 21 years
4. Performance status: ECOG 0-2.
5. Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases. 1. Heart: a shortening fraction \> 30% and ejection fraction \> 45%. 2. Liver: total bilirubin \< 2 × upper limit of normal; ALT \< 3 × upper limit of normal. 3. Kidney: creatinine \<2 × normal or a creatinine clearance (GFR) \> 60 ml/min/1.73m2.
6. Patients must lack any active viral infections or active fungal infection.
7. Appropriate donor is available: Matched in 6/6 of A, B, DR loci.
8. Patients (or one of parents if patients age \< 20) should sign informed consent.

Exclusion Criteria:

1. Pregnant or nursing women.
2. Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
3. Psychiatric disorder that would preclude compliance.

Primary outcomes:
measure: To evaluate 1-year event free survival after hematopoietic stem cell transplantation.
timeFrame: For 4 days used Buslufan through pharmacokinetic study in hematopoietic stem cell transplantation
Secondary outcomes:
measure: To evaluate engraftment rate, toxicities associated with hematopoietic stem cell transplantation, acute and chronic GVHD, treatment related mortality and relapse rate.
timeFrame: 1, 3, 6 and 12 months after transplantation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Daehangno, Jongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: Hyoung Jin Kang, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00426595: Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation
Official title: Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastreoesophageal Reflux Disease
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2007-01-25
Enrollment: 14
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Gastroesophageal reflux disease and reflux-esophagitis are a major chronic problem in most children with cerebral palsy and mental retardation. Oral administration of enteric-coated formulations of the acid-labile proton pump inhibitor omeprazole is often problematic in these patients who may be suffering from swallowing disorders. A suspension of omeprazole in a sodium bicarbonate solution is often used for administration via the gastrostomy tube. This trial aims to compare the pharmacokinetics of omeprazole administered through the gastrostomy tube as a suspension in pediatric patients with cerebral palsy and mental retardation versus the pharmacokinetics of omeprazole administered as a multi-unit-pellet system (MUPS®). The crossover study will consist of 2 consecutive treatment periods of 14 days.


Eligibility criteria: Inclusion Criteria:

* Children \> 15 kg
* Cerebral palsy and mental retardation with swallowing disorders
* Presence of gastrostomy tube
* GERD and/or reflux-esophagitis treated with omeprazole at the same dose since at least 2 weeks
* Informed consent

Exclusion Criteria:

* Treatment with ciclosporine, tacrolimus, mycofenolate
* Treatment with anticoagulants
* Infection
* Recent start of treatment with known inhibitors of the omeprazole-metabolism
* Moderate to severe hepatic impairment (SGPT and/or AST \> 3 times upper limit)

Primary outcomes:
measure: Pharmacokinetics (at the end of the treatment period of 14 days)
Secondary outcomes:
measure: Gastric pH (at the end of the treatment period of 14 days)
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Myriam Van Winckel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03012295: Genetic Testing of Monogenic Hypertension in Chinese Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Monogenic Hypertension
Keywords: Genetic Testing
Chinese Population
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 1000
Sex: ALL
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: High blood pressure outpatients and inpatients from national multi-hypertension center.

Brief summary: Monogenic hypertension, which follows the rules of Mendel's genetic law, is one of the most important causes of hypertension. Generally, patients occur hypertension in early age, have family history, and often manifest severe hypertension or refractory hypertension. At present, only a few hypertension centers of hospitals in China will help clinically difficult diagnosis hypertensive patients to test some selective genes, while most of other hospitals still perform diagnosis based on biochemical examination and clinical symptoms. Therefore, in order to provide better guidance for the diagnosis and treatment for hypertensive patients, this project aims to develop a single gene detection panel for genetic hypertension, so as to provide new diagnostic technology for early intervention, prevention and treatment of hypertension in clinics.


Eligibility criteria: Inclusion Criteria:

* hypertension patients meet one of the following criteria

  1. Beginning age of hypertension: \<35 years (regardless of family history of hypertension);
  2. refractory hypertension (blood pressure is difficult to control): triple antihypertensive drugs treatment for 1 months, 3 times of non-continuous high blood pressure in consulting room (SBP ≥140mmHg and/or DBP≥90mmHg);
* patients suspected of secondary hypertension, meeting one of the following criteria

  1. pheochromocytoma or Cushing syndrome;
  2. hypertension with hypokalemia;
  3. hypertension with hyperkalemia;
  4. hypertension with special body shape, such as central obesity, moon face, acne etc..
  5. adrenal tumor;

Exclusion Criteria:

* renal parenchymal / renovascular hypertension
* patients exceed age of 50, and with coronary heart disease and arteriosclerosis

Primary outcomes:
measure: number of genetic variants in Monogenic Hypertension patients as assessed by specific gene panel
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: CIFuwaiHospital
Study officials:
References:
Clinical trial NCT02787395: Self Reduction of Shoulder Dislocation
Official title: Patients Education of a Self-reduction Technique for Anterior Dislocation of Shoulder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Shoulder Dislocation
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-06-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anterior dislocation of the shoulder (glenohumeral joint) is one of the most prevalent dislocations. Following a first dislocation recurrence rates of up to 80% have been reported. Many patients will seek medical assistance for reduction of the shoulder after each of these recurrent dislocations. The investigators describe the results of reduction of anterior glenohumeral dislocation using a modified self manipulated Milch technique that can be performed by the patients themselves after simple guidance and demonstration. This method is directed to patients who are not willing or cannot have surgical stabilization and may be in a place where medical assistance is not available.


Eligibility criteria: Inclusion Criteria:

* anterior shoulder dislocation
* acute (24 hours) shoulder dislocation

Exclusion Criteria:

* shoulder fracture
* non-cooperative patient

Primary outcomes:
measure: rate of successfull self reduction
timeFrame: 10 minutes
Secondary outcomes:
measure: pain using VAS during reduction
timeFrame: 10 minutes
measure: patient satisfaction from self reduction process using VAS
timeFrame: 10 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00334295: Fulvestrant for the Treatment of Recurrent or Metastatic Endometrial Carcinoma.
Official title: An Open, Non-randomised Multicentre Phase II Study to Assess the Efficacy and Tolerability of a 250 mg Monthly Dose of i.m. Applied Fulvestrant for the Treatment of Recurrent or Metastatic Endometrial Carcinoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometrial Carcinoma
Keywords: Recurrent or metastatic endometrial carcinoma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-06-07
Enrollment: 35
Sex: FEMALE
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 determine the efficacy of a monthly administration of Fulvestrant in patients with recurrent or metastatic endometrial carcinoma by assessment of the clinical tumour response after 3 injections.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed, recurrent or metastatic endometrial carcinoma
* Postmenopausal
* Hormonreceptor positive

Exclusion Criteria:

* Pre-treatment with Fulvestrant
* Previous endocrine therapy of the endometrial carcinoma
* Previous malignancy less than 3 years ago other than in situ carcinoma of the cervix, basal cell carcinoma or squamous carcinoma of the skin

Primary outcomes:
measure: Determination (for ITT (Intet-to-Treat Set): Efficacy of a Monthly Administration of Fulvestrant in Patients With Recurrent or Metastatic Endometrial Carcinoma by Assessment of the Clinical Tumour Response After 3 Injections of Fulvestrant
timeFrame: up to 1 year
Secondary outcomes:
measure: Time to Progression of Disease (TTP-Time To Progression, for ITT Set)
timeFrame: ICF (Informed Consent Form completed) to the date of objective progression or death (by any cause in the absence of progression)
measure: Determination (for ITT Set): Median Survival
timeFrame: ICF to the date of death
measure: Determination (All Subjects Treated (AST) Set): Safety and Toxicity by Assessment of the Frequency of Grade I-IV Haematological and Non-haematological Toxicities
timeFrame: ICF to Last Patient Out (LPO)
measure: Evaluation (Patient-reported): Change From Baseline in Health-related Quality of Life (HR-QoL) at 12 Months (12 Visits)
timeFrame: ICF (Baseline) up to 12 months (12 visits)
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Research Site
city: Göttingen
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Jena
country: Germany
facility: Research Site
city: Lübeck
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Münster
country: Germany
facility: Research Site
city: Neunkirchen
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Germany Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01943981: Exercise Performance in Patients With Atrial Fibrillation
Official title: Exercise Performance in Patients With Atrial Fibrillation: Usefulness of Cardiopulmonary Exercise Test
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Lead sponsor: Incheon St.Mary's Hospital
Sponsor class: OTHER
First posted: 2013-09-17
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with atrial fibrillation and preserved left ventricular systolic function

Brief summary: Heart failure and stroke are the two major complication of atrial fibrillation. Current treatment for atrial fibrillation is so focused to stroke prevention, but the risk assessment for heart failure is less highlighted. The most of patients with atrial fibrillation have cardiac functional limitation of variable degree. We hypothesize that the exercise test would reveal the subclinical cardiac dysfunction, and might be helpful to classify the patients with atrial fibrillation according to their exercise capacity real cardiac function.


Eligibility criteria: Inclusion Criteria:

* Nonvalvular chronic atrial fibrillation
* Left ventricular ejection fraction \>40%

Exclusion Criteria:

* Acute decompensated heart failure within 30 days
* unstable hemodynamic status
* Significant coronary artery disease
* Any condition interfering sufficient exercise
* Valvular stenosis or regurgitation of moderate or severe degree
* Obstructive or restrictive lung disease of moderate or severe degree
* Active malignancy

Primary outcomes:
measure: Exercise response patterns of heart rate and oxygen uptake
timeFrame: At baseline
Secondary outcomes:
measure: Composite cardiovascular events (all death, admission of heart failure, stroke/thromboembolism)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Incheon St.Mary's Hospital
Study officials:
References:
Clinical trial NCT03743181: Impact of Clinical Pharmacy Services Provided for Patients With Active Rheumatoid Arthritis
Official title: Impact of Clinical Pharmacy Services Provided for Patients With Active Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: rheumatoid arthritis patients from outpatient clinics - Ain shams university hospitals

Brief summary: Enrolment of clinical pharmacy services in RA patients as a part of health care system has been investigated at many studies but not investigated in active RA patients before. This study aimed to detect drug therapy-related problems (DTRPs) in active rheumatoid arthritis (RA) patients and Investigate the impact of clinical pharmacist interventions on the patient clinical outcome and quality of life (QoL). Methods:Prospective, randomized controlled study to be carried out at rheumatology outpatient clinic, Ain Shams University Hospitals on 50 patients with active RA for 6 months.determine if any drug therapy problems are present.Develop a plan of care that includes interventions to resolve drug therapy problems, achieve goals of therapy, and prevent drug therapy problems. questionnaires was used to measure functional status in RA patients using health assessment questionnaire (HAQ) and assess self-reported quality of life in patients with (RA) using rheumatoid arthritis quality of life questionnaire (RAQOL) and measure adherence using the 4-item Morisky Green Levine Medication Adherence Scale and Disease Activity Score-28 was used as an objective method to assess RA disease activity.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-60 years old
* fulfillment of the American College of Rheumatology /European league against rheumatism (2010 ACR/EULAR ) diagnostic criteria for RA.
* patients with active RA(defined by DAS28 score \< 5.1)

Exclusion Criteria:

* Patients with cognitive impairment.
* The presence of hepatic or renal disease.
* The presence of other rheumatic and connective tissue disorders.

Primary outcomes:
measure: disease activity score
timeFrame: 6 months
measure: Quality of life questionnaire
timeFrame: 6 months
measure: Health assessment questionnaire
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Facuty of Pharmacu Ain Shams University
state: Abasiya
Study officials:
affiliation: teaching assistant at faculty of pharmacy ain shams university
name: hager omar m siddik
role: PRINCIPAL_INVESTIGATOR
References: