louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00828698: FINGER; Finland-Germany Myocardial Infarction Study
Official title: Finnish-German Prospective, Observational Follow-up Study on Risk Assessment of Mortality After Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: Death, sudden
All cause mortality
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Medical Council of the Finnish Academy of Science
name: Finnish Foundation for Cardiovascular Research
name: Bundesministerium für Bildung, Wissenschaft, Forschung und Technologie
name: Kommission für Klinische Forschung
name: German Research Foundation
First posted: 2009-01-26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients who have been hospitalized for acute myocardial infarction from Munich, Germany and Oulu, Finland

Brief summary: The purpose of this observational study is to find characteristics and risk stratification methods for identification of subjects who have increased risk of death, especially sudden cardiac death, after acute myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of acute myocardial infarction
* Consent to the study

Primary outcomes:
measure: All cause mortality
timeFrame: 10years
Secondary outcomes:
measure: Sudden cardiac death
timeFrame: 10 years
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Munich
country: Germany
facility: Deutsches Herzzentrum
Study officials:
References:
citation: Makikallio TH, Barthel P, Schneider R, Bauer A, Tapanainen JM, Tulppo MP, Perkiomaki JS, Schmidt G, Huikuri HV. Frequency of sudden cardiac death among acute myocardial infarction survivors with optimized medical and revascularization therapy. Am J Cardiol. 2006 Feb 15;97(4):480-4. doi: 10.1016/j.amjcard.2005.09.077. Epub 2005 Dec 22.
citation: Bauer A, Kantelhardt JW, Barthel P, Schneider R, Makikallio T, Ulm K, Hnatkova K, Schomig A, Huikuri H, Bunde A, Malik M, Schmidt G. Deceleration capacity of heart rate as a predictor of mortality after myocardial infarction: cohort study. Lancet. 2006 May 20;367(9523):1674-81. doi: 10.1016/S0140-6736(06)68735-7.
citation: Makikallio TH, Barthel P, Schneider R, Bauer A, Tapanainen JM, Tulppo MP, Schmidt G, Huikuri HV. Prediction of sudden cardiac death after acute myocardial infarction: role of Holter monitoring in the modern treatment era. Eur Heart J. 2005 Apr;26(8):762-9. doi: 10.1093/eurheartj/ehi188. Epub 2005 Mar 18.
citation: Peltola M, Tulppo MP, Kiviniemi A, Hautala AJ, Seppanen T, Barthel P, Bauer A, Schmidt G, Huikuri HV, Makikallio TH. Respiratory sinus arrhythmia as a predictor of sudden cardiac death after myocardial infarction. Ann Med. 2008;40(5):376-82. doi: 10.1080/07853890701884659.
Clinical trial NCT04371198: Patient-Derived Organoids for Rectal Cancer
Official title: Feasibility of Establishing Patient-Derived Organoids for Rectal Cancer: A Biospecimen Collection Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectum Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the feasibility of establishing patient-derived organoids from pre-treatment rectal adenocarcinoma biopsies.


Eligibility criteria: Inclusion

1. Age ≥18 years old.
2. Able to provide informed consent.
3. Undergoing proctoscopy.

Exclusion

1. Patient not planned to receive neoadjuvant radiotherapy

Primary outcomes:
measure: Number of Participants With Biopsies That Form Spherical Organoids
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Brian Czito, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00608998: Identification of Cardiovascular Risk Factors Linked to Renal Failure Progression
Official title: Vascular Risk Factors and Coronary Calcifications in Chronic Renal Failure Patients: Identification of Specific Factors Linked to Renal Failure Progression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Renal Failure
Keywords: Chronic renal failure
Vasculopathy
Cardiovascular risk
Chronic renal failure patients
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2008-02-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The aim of this study is to appreciate the influence of renal failure progression on vasculopathy (coronary calcifications and left ventricular hypertrophy) and cardiovascular risk factors.

Detailed description: The aim of this study is to appreciate the relationship between:

* extension of coronary calcifications and chronic renal failure progression
* extension of coronary calcifications and levels of osteoprotegerin (bone disease marker)
* cardiovascular risk factors and coronary calcifications
* cardiovascular risk factors and existence of cardiovascular diseases

Eligibility criteria: Inclusion Criteria:

* Patient who has signed the written consent form
* Patient aged \> 18 and \< 90 years
* Chronic renal failure defined by glomerular filtration rate (GFR)

  * group 1: GFR \>90 mL/min with urinary biological abnormalities and GFR comprised between 90 and 60 mL/min
  * group 2: GFR comprised between 60 and 30 mL/min
  * group 3: GFR \<30 mL/min but without dialysis therapy

Exclusion Criteria:

* Chronic renal failure patient requiring dialysis therapy

Primary outcomes:
measure: description of osteoprotegerin levels according to chronic renal failure progression
timeFrame: inclusion
Secondary outcomes:
measure: calcium score description according to chronic renal failure progression
timeFrame: inclusion
measure: osteoprotegerin description according to calcium score
timeFrame: inclusion
measure: relationship between cardiovascular risk factors and calcium score
timeFrame: inclusion
measure: relationship between cardiovascular risk factors and cardiovascular disease
timeFrame: inclusion
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire
Study officials:
affiliation: CHU Lapeyronie Montpellier France
name: Bernard CANAUD, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Lapeyronie Montpellier France
name: Jean-Paul CRISTOL, Pr
role: STUDY_CHAIR
affiliation: CHU Arnaud de Villeneuve Montpellier France
name: Hélène VERNHET, Pr
role: STUDY_CHAIR
affiliation: CHU Lapeyronie Montpellier France
name: Kada KLOUCHE, Dr
role: STUDY_CHAIR
affiliation: CHU Lapeyronie Montpellier France
name: Hélène LERAY-MORAGUES, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT01087398: Hematopoietic Stem Cell Transplantation for Malignant Infantile Osteopetrosis
Official title: Hematopoietic Stem Cell Transplantation for Malignant Infantile Osteopetrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Osteopetrosis
Keywords: Osteopetrosis
HSCT
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-03-16
Enrollment: 10
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and side effects of donor hematopoietic cells using chemotherapy regimen without total-body irradiation in children undergoing a hematopoietic stem cell transplant for Malignant infantile osteopetrosis. The blood stem cells will be derived from either related donor or unrelated umbilical cord blood or haploidentical donor.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Osteopetrosis confirm by bone biopsy and radiographic imaging
* Age up to 5 year old

Exclusion Criteria:

* Carbonic Anhydrase II (CAII) deficiency osteopetrosis variant
* Creatinine clearance ≤ 40ml/min/1.73m\^2 or RTA
* Bilirubin ≥ 3mg/dL
* SGPT ≥ 500 U/L
* Current severe infection
* Evidence of CNS involvement
* Morbidity such as blindness or deafness

Primary outcomes:
measure: Overall Survival and Progressive Free Survival in patient with infantile Osteopetrosis who receive allogeneic HSCT
timeFrame: 1 year
Secondary outcomes:
measure: One year overall survival after allogeneic HSCT
timeFrame: 1 year
measure: One year Progressive Free Survival after allogeneic HSCT
timeFrame: 1 year
measure: Transplantation Related Mortality (TRM) after allogeneic HSCT
timeFrame: 1 year
measure: Acute and chronic GVHD rate after allogeneic HSCT
timeFrame: 1 year
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Hematology-Oncology & SCT Research Center
Study officials:
affiliation: Hematology-Oncology and SCT Research Center
name: Amir Ali Hamidieh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04852198: Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Official title: A Study on Safety and Efficacy Comparing 150cm One Anastomosis Gastric Bypass With 150cm Biliopancreatic Limb Roux-en-Y Gastric Bypass (Roux-en-WHY?): An Open Label, Multicentre Non-inferiority Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bariatric Surgery Candidate
Obesity
Obesity, Morbid
Lead sponsor: Flevoziekenhuis
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with 2 groups
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficiency of OAGB compared to RYGB

Detailed description: Rationale: to compare two different types of gastric bypass operations on surgical outcome.

Objective: to compare two established procedures in order to find the optimal procedure in terms of weight loss and metabolic control that is associated with the fewest side-effects and complications, and decreased invasiveness.

Study design: A multicentre, open label, non-inferiority randomized controlled trial Study population: Patients are eligible for inclusion if their body-mass index (BMI) was 40 kg/m2 or higher, or 35 kg/m2 or higher with the presence of at least one comorbidity (type 2 diabetes, high blood pressure, obstructive sleep apnoea, dyslipidaemia, osteoarthritis of the hip or knee) and a positive evaluation by our bariatric multidisciplinary team (BMDT) and are aged 18-65.

Intervention: Group 1: One Anastomosis Gastric Bypass with 150cm biliopancreatic limb. Group 2: Roux-en-Y gastric bypass with biliopancreatic limb of 150cm and 75cm alimentary limb.

Main study parameters/endpoints:

Primary endpoint:

% Excess BMI loss at two years

Secondary endpoints:

Metabolic status Nutritional status Comorbidity remission QOL Complications or serious adverse events (SAE's)

Eligibility criteria: Inclusion Criteria:

* body-mass index (BMI) of 40 kg/m2 or higher, or 35 kg/m2 or higher with the presence of at least one comorbidity (type 2 diabetes, high blood pressure, obstructive sleep apnoea, dyslipidaemia, osteoarthritis of the hip or knee)
* a positive evaluation by our BMDT

Exclusion Criteria:

* Presence of H. Pylori, resistant to eradication therapy
* chronic diarrhoea
* history of previous bariatric or extensive abdominal surgery

Primary outcomes:
measure: Percentage excess BMI loss at 2 years (%EBMIL)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Almere
country: Netherlands
facility: Flevoziekenhuis
city: Amsterdam
country: Netherlands
facility: OLVG
Study officials:
affiliation: Flevoziekenhuis
name: Stef JM Smeets, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02280798: Endometrial Gene Expression in Different Protocols of Endometrial Preparation for Embryo Transfer'
Official title: Endometrial Gene Expression in Different Protocols of Endometrial Preparation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial
Keywords: ERA
Lead sponsor: IVI Madrid
Sponsor class: OTHER
Collaborators: name: Igenomix
First posted: 2014-11-02
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 5 volunteers from our egg donation program were included in the study from Setember 2014 to jnuary 2015

Brief summary: Do differences in endometrial gene expression exist after different protocols of endometrial preparation for embryo transfer? The recent apparition of endometrial receptive arrays technology let us know if endometrial is receptive or not in patients with some problems of infertility as implantation failure, for that we want to know if this technology would tell us if the different kind of protocols for endometrial preparation origin differences that could explain some of the founded results.

Detailed description: Do differences in endometrial gene expression exist after different protocols of endometrial preparation for embryo transfer? The clinical results in different publications showed different results, some of them described the natural cycle superior as the substituted cycles, and in contrast other large series showed superior results in substituted cycles than natural but with an increased of pregnancies losses. The recent apparition of endometrial receptive arrays technology let us know if endometrial is receptive or not in patients with some problems of infertility as implantation failure, for that we want to know if this technology would tell us if the different kind of protocols for endometrial preparation origin differences that could explain some of the founded results.

Eligibility criteria: Inclusion Criteria:

* age between 18 and 35 years
* regular menstrual cycles (between 25 and 35 days)
* normal basal hormones(follicle-stimulating hormone \[FSH\] and LH \<10 IU/ mL and estradiol \<60 pg/mL)
* normal karyotype
* body massindex between 18 and 25 kg/m2
* negative serology
* normal cervical cytology in the past year, and a vaginal ultrasound without evidence of any pathologic conditions

Exclusion Criteria:

* endometriosis
* polycystic ovariansyndrome
* use of an intrauterine device in the last 3 months.

Primary outcomes:
measure: Endometrial receptivity
timeFrame: 4 months
Secondary outcomes:
measure: Hormonal profile
timeFrame: LH,E2,P4
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Maria Cerrillo
Study officials:
affiliation: IVI Madrid
name: Cerrillo M Maria, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01183598: A Study to Provide RoActemra/Actemra (Tocilzumab) to Patients With Multicentric Castleman's Disease Who Demonstrated Benefit From Previous RoActemra/Actemra Treatment
Official title: Provision of Tocilizumab for Patients With Multicentric Castleman's Disease Who Have Demonstrated Benefit From Previous Tocilizumab Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Castleman's Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-08-17
Enrollment: 3
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: This open-label, single center study will provide RoActemra/Actemra (tocilizumab) to a maximum of 4 patients with Multicentric Castelman's Disease who have demonstrated benefit from RoActemra/Actemra in study MRA004US (Chugai Pharma USA) without major toxicities or significant adverse events. Patients will receive their most effective maintenance dose until disease progression or significant toxicity occurs.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Evidence of improvement of one or more clinical benefit criteria with acceptable tolerability to RoActemra/Actemra in Protocol MRA001US, maintained clinical benefit in MRA004US, and completion of MRA004US
* Life expectancy \> 12 weeks
* Zubrod performance status \</= 3

Exclusion Criteria:

* Serious toxicity including anaphylactic reactions to tocilizumab during the MRA004US trial
* Any treatment for Multicentric Castleman's Disease except for corticosteroids within 2 weeks prior to Day 1
* Active infection requiring iv antibiotics for \> 1 month and not resolving at least 1 week prior to Day 1; iv antibiotics prophylaxis for infections of implanted venous access portals is allowed
* Active viral infection within 28 days prior to Day 1
* Treatment with any investigational agent other than RoActemra/Actemra within 30 days prior to baseline

Primary outcomes:
measure: Efficacy: Maintenance of hemoglobin >/=10.5 g/dL, of Zubrod Performance Status, and of improvement in fatigue and anorexia as per National Cancer Institute Common Toxicity Criteria (NCI CTC) scales
timeFrame: until disease progression or significant toxicity occurs
measure: Safety: Adverse events, laboratory parameters, vital signs, electrocardiograms, chest X-rays
timeFrame: up to 90 days after discontinuation of treatment
measure: Provision of tocilizumab for treatment of Multicentric Castleman's Disease to patients with evidence of clinical benefit in response to tocilizumab
timeFrame: until disease progression or significant toxicity occurs
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01234298: SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia
Official title: A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Low- and High-dose Range Groups of SPD489 as Adjunctive Treatment to Established Maintenance Doses of Antipsychotic Medications on Negative Symptoms in Clinically Stable Adults Who Have Persistent Predominant Negative Symptoms of Schizophrenia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Negative Symptoms of Schizophrenia
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2010-11-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the safety and efficacy of SPD489 low-dose and high-dose treatment groups to placebo when given as adjunctive therapy to antipsychotic medication in clinically stable adults with persistent predominant negative symptoms of schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Subject has diagnosis of schizophrenia for at least 2 years
* Subject has persistent predominant negative symptoms
* Subject has 2 or more persistent predominant negative symptoms (affective flattening, alogia, avolition apathy, and anhedonia-asociality) determined to have been present for at least 6 months
* Subject is maintained on antipsychotic monotherapy or polytherapy with no more than 2 antipsychotic medications
* Subject has been clinically stable and is in the non-acute phase of illness

Exclusion Criteria:

* Subject has clinically notable positive symptoms
* Subject is considered to be treatment refractory
* Subject has current history of substance abuse/dependance
* Subject is considered a suicide risk or risk to harm others

Primary outcomes:
measure: Negative Symptom Assessment (NSA-16) total score
timeFrame: up to 26 weeks
Secondary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: up to 26 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00666198: Special Investigation For Long-Term Use Of Sildenafil (Regulatory Post Marketing Commitment Plan)
Official title: Special Investigation For Long-term Use Of Revatio (Regulatory Post Marketing Commitment Plan)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-24
Enrollment: 3337
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an investigator involving A1481263 prescribes the SILDENAFIL(Revatio).

Brief summary: The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Detailed description: All the patients whom an investigator prescribes the first SILDENAFIL(Revatio) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria: Inclusion Criteria:

* Patients need to be administered SILDENAFIL(Revatio) in order to be enrolled in the surveillance.

Exclusion Criteria:

* Patients not administered SILDENAFIL(Revatio).

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events
timeFrame: 3 years
measure: Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
timeFrame: 3 years
measure: Number of Paritcipants With Treatment-Related Adverse Events by Age
timeFrame: 3 years
measure: Number of Paritcipants With Treatment-Related Adverse Events by Gender
timeFrame: 3 years
measure: Number of Participants With Treatment-Related Adverse Events by Disease Type
timeFrame: 3 years
measure: Number of Participants With Treatmnt-Related Adverse Events by WHO Functional Classification of Severity
timeFrame: 3 years
measure: Clinical Efficacy Rate by Age
timeFrame: 3 years
measure: Clinical Efficacy Rate by Gender
timeFrame: 3 years
measure: Clinical Efficacy Rate by Disease Type
timeFrame: 3 years
measure: Clinical Efficacy Rate by WHO Functional Classificaton of Severity
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: