louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00212394: Tourniquet Complications in Orthopaedic Surgery
Official title: A Prospective, Epidemiological Study of the Incidence and Nature of Tourniquet Complications in Norway
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tourniquet Complications
Paresis
Palsy
Nerve Compression
Keywords: Tourniquet
paresis
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The purpose of the study is to establish the number and nature of complications that we, the researchers, have with the use of a tourniquet in orthopaedic surgery in Norway.

Detailed description: This is a multicenter, prospective study where contact persons in 10 different hospitals throughout Norway monitor problems and complications that occur in relation with tourniquet use in orthopaedic surgery. If a complication occurs, it is documented in detail by the contact person.

Eligibility criteria: Inclusion Criteria:

* All patients in 10 orthopaedic hospitals in Norway undergoing surgery which requires a tourniquet, from 1 january to 31 of december 2005

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: National Taiwan Normal University
name: Vilhjalmur Finsen, Profesor
role: STUDY_DIRECTOR
References:
citation: Odinsson A, Finsen V. Tourniquet use and its complications in Norway. J Bone Joint Surg Br. 2006 Aug;88(8):1090-2. doi: 10.1302/0301-620X.88B8.17668.
Clinical trial NCT01833494: A Long-term Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
Official title: A Long-term Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemodialysis Patients With Hyperphosphatemia
Keywords: Hemodialysis
Hyperphosphatemia
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-04-17
Enrollment: 161
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety and efficacy for 52-week dosing in hemodialysis patients with hyperphosphatemia.


Eligibility criteria: Inclusion Criteria:

* Receiving stable maintenance hemodialysis 3 times a week.
* Dialysis patients with hyperphosphatemia

Exclusion Criteria:

* Patients having history of a pronounced brain / cardiovascular disorder.
* Patients having severe gastrointestinal disorders.
* Patients having severe hepatic disorders.

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: 52 weeks
Secondary outcomes:
measure: Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)
timeFrame: 52 weeks
measure: Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)
timeFrame: 52 weeks
measure: Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: JAPAN
Study officials:
References:
Clinical trial NCT02233894: Post-marketing Surveillance of Atrovent® Inhalets in Chronic Obstructive Pulmonary Disease
Official title: Post-marketing Surveillance (as Per § 67(6) AMG [German Drug Law]) of Atrovent® Inhalets in Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-09
Enrollment: 526
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with chronic obstructive pulmonary disease recruited at general practitioners

Brief summary: Study to obtain further information on the tolerability and efficacy of Atrovent® inhalets in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice


Eligibility criteria: Inclusion Criteria:

* Patients of both genders older than 40 years, who suffer from Chronic Obstructive Pulmonary Disease
* Only patients who have not been treated with Atrovent® within the last year are to be considered for inclusion

Exclusion Criteria:

* Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Atrovent® metered dose inhaler

Primary outcomes:
measure: Change in overall severity of the clinical picture
timeFrame: 3 months
Secondary outcomes:
measure: Assessment of efficacy by investigator on a 4-point scale
timeFrame: after 3 months
measure: Assessment of efficacy by patient on a 4-point scale
timeFrame: after 3 months
measure: Number of patients with adverse drug reactions
timeFrame: 3 months
measure: Assessment of tolerability by investigator on a 4-point scale
timeFrame: after 3 months
measure: Assessment of tolerability by patient on a 4-point scale
timeFrame: after 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00200694: Anti-Proteinuric Response to ACEI, ARB and Diuretics Combination.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heavy Proteinuria
Keywords: Proteinuria
ACEI
ARB
diuretics
blood pressure
renal failure
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Determine the best strategy for proteinuria lowering in patients with proteinuria \> 1 g/day receiving ACEI and ARB combination: either increase of ACEI and ARB dosage or increase of diuretic dosage.


Eligibility criteria: Inclusion Criteria:

* proteinuria \> 1 g/day with ramipril 5 + valsartan 80 mg/day for 2 months
* proteinuria changes \< 50% on 3 separate dosages over 2 months.

Exclusion criteria:

* age \< 18 or \> 80 years systolic BP \< 110 or ≥ 140 mmHg, serum creatinine \> 250 mmole/L
* serum creatinine increase on ramipril + valsartan \> 20%
* intolerance to ACEI or ARB

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: Nantes University Hospital
name: Vincent LM Esnault, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01245894: Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment
Official title: Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on the Coronary Microcirculation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction [C14.907.585.500]
Keywords: Index of microcirculatory resistance
Fractional Flow Reserve
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2010-11-23
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to measure the effect of low- and high-dose lipid-lowering treatment with rosuvastatin on the coronary physiology parameters.


Eligibility criteria: Inclusion Criteria:

1. ST-segment elevation myocardial infarction
2. no prior treatment with statins and
3. a non significant lesion in one of the two non-culprit coronary arteries

Exclusion Criteria:

1. age below 18 or above 81 years,
2. unconscious patients,
3. serum creatinine \> 176μmol/L,
4. hypothyroidism ((TSH \> 1.5 x ULN (upper limit of normal)),
5. current liver disease (ALAT \> 2 x ULN),
6. unexplained creatine kinase \> 3 x ULN,
7. alcohol or drug abuse within the last five years,
8. prior myopathy or serious hypersensitivity reaction caused by statins,
9. women with childbearing potential who were not using chemical or mechanical contraception,
10. pregnant or breastfeeding women,
11. history of malignancy unless a disease-free period of more than five years was present,
12. patients with abnormal lung function test (LFT),
13. participation in another investigational drug study less than four weeks before enrolment in the present study,
14. treatment with cyclosporine or fibrates

Primary outcomes:
measure: The primary endpoint was the change from baseline in Index of microcirculatory resistance(IMR).
timeFrame: One year
Secondary outcomes:
measure: The secondary endpoints were the changes from baseline in Fractional Flow Reserve (FFR) and lipid values.
timeFrame: One year
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Cardiology, Odense University Hospital
state: Fuenen
Study officials:
affiliation: Department of Cardiology, Odense University Hospital
name: Rasmus Egede, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02812394: A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets
Official title: A Phase 1 Single Dose Pharmacokinetic Bridging Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson Disease
Keywords: Parkinson's disease
Episodic motor fluctuations (OFF periods)
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-06-24
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will be an open-label, randomized, three-period cross-over pharmacokinetic evaluation of CVT-301 compared with the Reference Listed Drug (RLD), orally administered carbidopa/levodopa, in healthy volunteers.

Detailed description: The primary objective is to determine the relative bioavailability of two CVT-301 (dose levels 1 and 2) capsules compared with the Reference Listed Drug (RLD) on a per milligram basis.

Eligibility criteria: Inclusion Criteria:

* In good general health as determined by medical history, physical examination, electrocardiogram (ECG), vital signs, and clinical laboratory evaluation;
* FEV1/FVC above the 5th percentile of the predicted normal distribution for age and gender;
* Body Mass Index (BMI) between 18 - 30 kg/m2

Exclusion Criteria:

* No flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening Visit;
* Negative drug and alcohol testing;
* Negative pregnancy test for female subjects

Primary outcomes:
measure: Maximum observed plasma drug concentration (Cmax)
timeFrame: within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose.
measure: Area under the plasma concentration curve from time 0 to the concentration at 24 hours (AUC0-24h)
timeFrame: within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose.
Secondary outcomes:
measure: Number of subjects with Adverse Events (AEs) including Serious AEs
timeFrame: up to 9 days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Site #001
state: Texas
Study officials:
affiliation: Acorda Therapeutics
name: Charles Oh, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05505994: The Efficacy and Safety of DWP16001 in Combination With Metformin in T2DM Patients Inadequately Controlled on Metformin
Official title: A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Therapeutic Confirmatory Study and Open-Label Extension Study to Evaluate the Efficacy and Safety of DWP16001 Add-on to Metformin in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Disease
Endocrine System Diseases
Keywords: Dapagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2022-08-18
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

Brief summary: Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.

Detailed description: A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.

Eligibility criteria: Inclusion Criteria:

1. Subjects with T2DM aged 18 to 80 years
2. Subjects who have received metformin alone at a fixed dose for the last 8 weeks and has 7% ≤ HbA1c ≤ 10.5%
3. Subjects with BMI of 20-45 kg/m2
4. Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study

Exclusion Criteria:

1. Subjects with current or history of hypersensitivity to the IP of this study, metformin or drugs of the same class and their components (e.g., history of hypersensitivity to biguanide or SGLT2 inhibitors)
2. Diabetic ketoacidosis, diabetic coma or precoma within the past year
3. Urinary tract infections or genital infections within
4. Uncontrolled hypertension (SBP \> 180 mmHg or DBP \> 110 mmHg)
5. eGFR \< 60 mL/min/1.73 m2
6. Severe heart failure (NYHA class III/IV)

Primary outcomes:
measure: Change from baseline in HbA1c
timeFrame: at 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Linong Ji, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02097394: The Clinical Study on Combizym and Bifidobacteri to Prevent the Recurrence of Colon Polyps
Official title: A Randomized Controlled Study on Combizym and Bifidobacteria to Prevent the Recurrence of Colon Polyps
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Combizym
Bifidobacteri
Colon Polyps
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2014-03-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study hypothesis is whether digestion enzyme(Combizym) and intestinal flora drugs(Bifidobacteria) can decease recurrence rate of colon polyps

Detailed description: Colon polyps has high recurrence rate in the digestion diseases. However, the reasons are not clear. The possible reasons for the recurrence of colon polyps include intestinal inflammation (e.g., Ulcerative colitis), intestinal flora imbalance (the benefit intestinal bacteria reduced, which lead to diarrhea or constipation), long-term indigestion. The investigators propose to examine whether digestion enzyme (Combizym) and intestinal flora drugs(Bifidobacteria) can decease recurrence rate of colon polyps

Eligibility criteria: Inclusion Criteria:

-Patients who have cutted colon polyps in one month, and the diagnosis were proved by pathological analysis

Exclusion Criteria:

* have organic or other functional disease
* pregnant or breast-feeding

Primary outcomes:
measure: recurrence of colon polyps
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Shengliang Chen
role: STUDY_DIRECTOR
References:
Clinical trial NCT02570594: Autobiographical Memory Organization in Schizophrenia
Official title: Autobiographical Memory Organization in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Cognition
Autobiographical
memoryCognitive
remediation
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-10-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to investigate the temporal organization of autobiographical memory in patients with schizophrenia. Patients and control participants will be invited separately to participate in a 1hour walk in the city of Strasbourg and at the same time, to carry an automatic camera around their neck, which is called SenseCam®. Pictures obtained with SenseCam® will be later presented to the participants during the session of test. They will be asked to determine the chronological order of 12 pictures corresponding to 12 particular events of the tour. Then they will be asked to watch the complete sequence of photos from the tour and to determine the beginning and ending of the events that have occurred during the tour. According to the investigators hypotheses, patients should have difficulty to find out the correct chronological order of the photos and to determine the appropriate beginnings and endings of the events


Eligibility criteria: Inclusion Criteria:

* for both patients and controls
* male or female willing to participate and who have signed up the legal document
* under the protection of health insurance for patients only
* schizophrenia or schizo-affective disorder according to the DSM-IV-TR criteria
* clinically stable for at least 2 months for controls only
* no psychiatric history

Exclusion criteria:

* for both patients and controls
* current severe or unstable somatic illness
* neurological history (epilepsia, brain injury, brain surgery...)
* current substance use disorder (DSM-IV-TR)
* current major depressive disorder (DSM-IV-TR)
* mental retardation (IQ \< 70)
* pregnancy, breast feeding
* current legal control for patients only
* treatment comprising benzodiazepines
* benzodiazepines intake during the last 3 weeks for controls only
* psychotropic intake during the last 3 weeks

Primary outcomes:
measure: Specificity of memories recovered by using the SenseCam camera during the trial
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de psychiatrie 1 , Les Hôpitaux Universitaires de Strasbourg
state: Alsace
Study officials:
References:
Clinical trial NCT03381794: The German Keratoplasty Registry of the German Ophthalmological Society (DOG)
Official title: Trends in Corneal Transplantation from 2001 in Germany: Reports of the DOG-Section Cornea and Its Keratoplasty Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Corneal Transplantation
Keywords: Keratoplasty Registry, PKP, DSAEK, DMEK, DALK
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
Collaborators: name: University Eye Hospital, Freiburg
name: University of Erlangen-Nürnberg
name: University of Cologne
name: Heinrich-Heine University, Duesseldorf
name: Charite University, Berlin, Germany
First posted: 2017-12-22
Enrollment: 100000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients in Germany treated with the different types of corneal transplantation since 2001.

Brief summary: Aim of this study is to reflect on the changing trends in absolute numbers, surgical techniques and indications of corneal transplantations being performed in Germany.

The Section Cornea of the German Ophthalmological Society provides interim-assessments on a regular basis about the most up-to-date results of this long-term study.


Eligibility criteria: Inclusion Criteria:

All patients in Germany treated with the different types of corneal transplantation since 2001.

Exclusion Criteria:

Patients without corneal transplantation.

Primary outcomes:
measure: An overview about absolute numbers of corneal transplantation in Germany.
timeFrame: 01/01/2001 to 31/12/2031
measure: An overview about trends in the various types of corneal transplantation in Germany.
timeFrame: 01/01/2001 to 31/12/2031
measure: An overview about indications for corneal transplantation in Germany.
timeFrame: 01/01/2001 to 31/12/2031
Secondary outcomes:
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Department of Ophthalmology
state: Saarland
Study officials:
affiliation: Universität des Saarlandes
name: Berthold Seitz, Prof.Dr.med.
role: STUDY_DIRECTOR
References:
citation: Flockerzi E, Turner C, Seitz B, Collaborators GSG; GeKeR Study Group. Descemet's membrane endothelial keratoplasty is the predominant keratoplasty procedure in Germany since 2016: a report of the DOG-section cornea and its keratoplasty registry. Br J Ophthalmol. 2024 May 21;108(5):646-653. doi: 10.1136/bjo-2022-323162.
citation: Flockerzi E, Maier P, Bohringer D, Reinshagen H, Kruse F, Cursiefen C, Reinhard T, Geerling G, Torun N, Seitz B; all German Keratoplasty Registry Contributors. Trends in Corneal Transplantation from 2001 to 2016 in Germany: A Report of the DOG-Section Cornea and its Keratoplasty Registry. Am J Ophthalmol. 2018 Apr;188:91-98. doi: 10.1016/j.ajo.2018.01.018. Epub 2018 Feb 2.