louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00222053: IFM 99-02 Thalidomide in Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Myeloma
Autologous transplantation
Maintenance therapy
Thalidomide
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 800
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: Principal objective is to evaluate the impact of Thalidomide to prolong the duration of response after autologous transplantation for myeloma


Eligibility criteria: Inclusion Criteria:

* de novo myeloma
* according to Durie and Salmon classification stage II, III and stage I with a lytic bone lesion
* patients from 18 to 65 years old
* beta2microglobulin \< 3 mg/l or del13 absent
* signed informed consent
* eligible for transplantation

Exclusion Criteria:

* peripheral neurological toxicities
* uncontrolled or severe cardiovascular disease
* other malignancy except basocellular carcinoma or FIGO stage I carcinoma of the cervix
* patient who received biphosphonate during the last 60 days
* renal failure definited as creatinine \> 150 µmol/l
* patient with obvious vascular cerebral medical history
* liver dysfunction definited as bilirubin \> 35 µmol/l or ASAT, ALAT, PAL \> 4N
* respiratory dysfunction
* HIV +
* Patient who refused to use an acceptable barrier method for contraception

Primary outcomes:
measure: Duration of response
timeFrame: 3 years
Secondary outcomes:
measure: Survival
timeFrame: 3 years
measure: Toxicity
timeFrame: 3 years
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Médecine Interne, CHU Purpan
city: Toulouse
country: France
facility: Médecine Interne, Hôpital Rangueil
city: Toulouse
country: France
facility: Rhumatologie, CHU Purpan
city: Toulouse
country: France
facility: Rhumatologie, CHU Rangueil
city: Toulouse
country: France
facility: Service d'hématologie, CHU Purpan
Study officials:
affiliation: CHU Toulouse
name: ATTAL Michel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Combination chemotherapy versus melphalan plus prednisone as treatment for multiple myeloma: an overview of 6,633 patients from 27 randomized trials. Myeloma Trialists' Collaborative Group. J Clin Oncol. 1998 Dec;16(12):3832-42. doi: 10.1200/JCO.1998.16.12.3832.
citation: Attal M, Harousseau JL, Stoppa AM, Sotto JJ, Fuzibet JG, Rossi JF, Casassus P, Maisonneuve H, Facon T, Ifrah N, Payen C, Bataille R. A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Francais du Myelome. N Engl J Med. 1996 Jul 11;335(2):91-7. doi: 10.1056/NEJM199607113350204.
Clinical trial NCT04462653: Evaluation of the Detection of Atrial Fibrillation by a Wearable Dynamic ECG Recorder
Official title: Evaluation of the Consistency Between the Detection of Atrial Fibrillation by a Wearable Dynamic ECG Recorder and a Control Instrument
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Huami Corporation
Sponsor class: INDUSTRY
First posted: 2020-07-08
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: A Randomized, Crossover Trial is conducted to Evaluate Consistency Atrial fibrillation diagnosis between the Wearable Dynamic ECG Recorder and the Control device.

In this investigation, the following indicators is also evaluated:

1. Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation compared with physician-adjudicated Gold Standard ECG recorder.
2. Waveform qualitative assessment
3. Safety incident assessments. 114 subjects (60 healthy subjects in phase I and 54 subjects with atrial fibrillation diagnosis in phase II) are enrolled in the investigation according to the criteria.


Eligibility criteria: Inclusion Criteria:

* - All study participants must be able to provide written informed consent prior to study procedure. This study has 2 Phases.

Phase 1:

* Health conscious individuals
* \> 18 years of age

Phase 2:

* \> 18 years of age
* non critical patients ever diagnosed with atrial fibrillation

Exclusion Criteria:

* • \< 18 years old

  * Unable to consent

Phase 1:

* \> 80 years of age
* Previous history of cardiac disease (e.g., atrial fibrillation, myocardial infarction, congestive heart failure)
* current status of non-sinus heart rhythm

Phase 2:

- Critical patients

Primary outcomes:
measure: Consistent rate of atrial fibrillation diagnosis
timeFrame: second 60
Secondary outcomes:
measure: Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation
timeFrame: second 60
measure: waveform qualitative assessment 1
timeFrame: second 60
measure: waveform qualitative assessment 2
timeFrame: second 60
Other outcomes:
measure: Safety measures 1
timeFrame: second 60
measure: Safety measures 2
timeFrame: second 60
measure: Safety measures 3
timeFrame: second 60
Locations:
city: Shanghai
country: China
facility: Shanghai Chest hospital
Study officials:
References:
Clinical trial NCT00528853: Correlation of Lung Biopsy, BAL, and High Resolution CT Scan in Lung Transplantation
Official title: Correlation of Lung Biopsy, BAL, and High Resolution CT Scan in Lung Transplantation. Can We Help Diagnose Acute Rejection and Better Predict Bronchiolitis Obliterans?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchiolitis Obliterans Syndrome
Keywords: Bronchiolitis Obliterans Syndrome
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2007-09-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lung transplant patients meeting inclusion criteria will be recruited from the lung transplant clinic.

Brief summary: A major source of graft failure and dysfunction in lung transplantation is known to be bronchiolitis obliterans (BO)and its clinical correlate called bronchiolitis obliterans syndrome(BOS). In fact, BOS is the leading cause of death in lung recipients beyond one year post transplant. Currently, our ability to assess lung injury after transplant is less than ideal.

The purpose of this study is to use new computerized tomography(CT) technology, specifically , 64 bit acquisition, to detect and predict the onset of lung injuries, with the hope of finding better therapies that currently exist.

Detailed description: Total enrollment : 10

Lung transplant patients will undergo CT Scans before scheduled bronchoscopies which are routinely performed at 1, 3, 6, 9, and 12 months post transplant. Imaging will be done with the newest generation scanner, with intent to analyze all pertinent areas of the lung for pathology, but especially the bronchial anastomoses, the lung parenchyma with focus on gas exchanging lobules of the lung, and any suspected abnormalities from physical exam, laboratory tests, or prior chest xray.

CT imaging will precede bronchoscopy and biopsy so that CT interpretation will be unencumbered by changes due to the bronchoscopic procedure.

Eligibility criteria: Inclusion Criteria:

* Lung transplant patients who are at least 18 years of age.
* All patients must be able to give written informed consent.

Exclusion Criteria:

* Lung transplant patients who are unable to undergo a CT Scan.
* Lung transplant patients who are unable to give informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Edward Garrity, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06972953: NEUROvascular NAVgation With Remotely Controlled Deflectable Guidewire, Study I (NeuroNAV Study I)
Official title: NEUROvascular NAVgation With Remotely Controlled Deflectable Guidewire, Study I (NeuroNAV Study I)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Unruptured Cerebral Aneurysm
Lead sponsor: Artiria Medical
Sponsor class: INDUSTRY
First posted: 2025-05-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the study is to confirm the safe and successful use of the SmartGUIDE guidewire, when used in neuro interventions. The performance of the SmartGUIDE guidewire in terms of safe and successful navigation within the neurovasculature will be compared to standard of care guidewire on the market.


Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* Informed consent signed by the patient
* Confirmed cerebral unruptured aneurysm treatable via transcatheter approach

Exclusion Criteria:

* Pregnancy or lactation
* Known disorder of vascular fragility with propensity to vascular injury (e.g., Ehlers-Danlos syndrome)
* Known prior vascular stenosis or dissection or injury to vessels intended to be catheterized during study procedures
* Acute phase myocardial infarction or uncontrolled cardiac arrhythmia
* Uncontrolled serum electrolyte imbalance
* Bleeding disorder which limits the use of antiplatelet and/or anticoagulant therapy
* Known contraindication to intravascular contrast material that cannot be adequately controlled with pre-medication
* Known hypersensitivity to Nickel
* Subjects currently enrolled in another investigational device or drug study that clinically interferes with the current study endpoints

Primary outcomes:
measure: Performance
timeFrame: During index procedure
Secondary outcomes:
measure: Usability
timeFrame: During index procedure
measure: Procedural times
timeFrame: During index procedure
measure: Intra-procedural adverse events
timeFrame: During index procedure and up to 48 hours post procedure
measure: Intra-procedural device deficiencies
timeFrame: During index procedure
Other outcomes:
Locations:
city: Limoges
country: France
facility: Centre Hospitalier Universitaire - CHU Limoges
Study officials:
affiliation: Centre Hospitalier Universitaire - CHU Limoges
name: Prof. Dr. Aymeric Rouchaud
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00145353: Insulin NovoRapid Versus Actrapid in Treatment of Type 1 Diabetic Patients During Daily Adjustment of Insulin Dose
Official title: Is Insulin NovoRapid Better Than Actrapid for Treating Type 1 Diabetic Patients When Simultaneously, Daily Adjusting the Insulin Dose?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 1 Diabetes Mellitus
Keywords: type 1 diabetes mellitus
hypoglycaemia
insulin profiles
growth hormone
cortisol
glucagon
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2005-09-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main purpose of the study is to investigate the reason for the reduced number of hypoglycaemic attacks in type 1 diabetic patients when, for a period of time, using Insulin Aspart at meals together with NPH insulin mornings and evenings, and when, in another period of time, using human fast-working insulin at meals and NPH insulin mornings and evenings, and when the patients in both periods simultaneously take extra insulin at meals if high blood glucose values are found before meals.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus treated with insulin four times daily (basal bolus treatment) at least three months before screening.
* AGe: 18-60 years
* BMI: 18-27.5
* No nefro- or neuropathy; i.e. S-creatinin below 120 μmol/l and normal monofilament examination
* Written informed consent

Exclusion Criteria:

* Pregnant women or patients planning to become pregnant during the investigation period
* Reduced eyesight; i.e. visus \> 0.3 evaluated at the latest eye exam.
* Patient lacking the ability to sens insulin sensitivity
* Serious rival disease, i.e. heart disease, severe liver or lung impairment, severe psychiatric disease.
* Suspicion of abuse or non-compliance
* Participation in another clinical trial

Primary outcomes:
measure: Meal-regulated insulin time two peaks after the two intervention periods
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Diabetes Research Center
state: Funen
Study officials:
affiliation: Odense University Hospital
name: Iben B. Jacobsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00882453: Physical Activity and Fatigue in Early Multiple Sclerosis (MS)
Official title: Betaferon Treatment and Exercise Data Gathering IN Early MS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Physical Activity
Fatigue
RRMS
CIS
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-04-16
Enrollment: 1739
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after a first demyelinating event suggestive of MS as well as patients with recently diagnosed RRMS (\< 12 months)

Brief summary: The purpose of this observational study is to obtain a survey on physical activity in patients who for the first time have experienced symptoms which indicate a high risk for developing multiple sclerosis (MS) and in patients with recently diagnosed MS, and to obtain information on factors potentially influencing the patients' level of activity.


Eligibility criteria: Inclusion Criteria:

* Multiple sclerosis diagnosed within the last 12 months
* Clinically isolated Syndrome (CIS), under Interferon-beta-1b treatment

Primary outcomes:
measure: Physical Activity and Fatigue
timeFrame: At baseline and at Month 24
Secondary outcomes:
measure: Health-related Quality of Life
timeFrame: At baseline and at Month 24
measure: Depression
timeFrame: At baseline and at Month 24
Other outcomes:
Locations:
city: Many Locations
country: Australia
city: Many Locations
country: Austria
city: Many Locations
country: Bahrain
city: Many Locations
country: Belgium
city: Many Locations
country: Canada
city: Many Locations
country: Colombia
city: Many Locations
country: Czech Republic
city: Many Locations
country: Denmark
city: Many Locations
country: Egypt
city: Many Locations
country: France
city: Many Locations
country: Germany
city: Many Locations
country: Greece
city: Many Locations
country: Indonesia
city: Many Locations
country: Israel
city: Many Locations
country: Italy
city: Many Locations
country: Jordan
city: Many Locations
country: Kazakhstan
city: Many Locations
country: Korea, Republic of
city: Many Locations
country: Kuwait
city: Many Locations
country: Lebanon
city: Many Locations
country: Mexico
city: Many Locations
country: Netherlands
city: Many Locations
country: Norway
city: Many Locations
country: Oman
city: Many Locations
country: Portugal
city: Many Locations
country: Slovenia
city: Many Locations
country: Spain
city: Many Locations
country: Sweden
city: Many Locations
country: Switzerland
city: Many Locations
country: Taiwan
city: Many Locations
country: Thailand
city: Many Locations
country: United Arab Emirates
city: Many Locations
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01538953: Pakistan Flocculent Health Outcome Study
Official title: Pakistan Flocculent Health Outcome Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhea
Keywords: diarrhea
handwashing
point-of-use water treatment
diarrhea longitudinal prevalence
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Health Oriented Preventive Education
name: Procter and Gamble
First posted: 2012-02-27
Enrollment: 8949
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to evaluate the effect of different methods of drinking water treatment on the occurrence of diarrhea among children living in squatter settlements in Karachi, Pakistan, and the marginal benefit of adding handwashing to water treatment. 260 households will receive a new product which combines flocculation with chlorination to produce clearer, less chemically contaminated drinking water. 260 households will receive dilute sodium hypochlorite, i.e. bleach to treat their water. 260 households will receive soap and encouraged to wash their hands regularly. 260 households will receive both soap and the combination flocculation/chlorination water treatment. 260 households will continue their standard water treatment and handwashing practices. The households will be visited each week for 9 months, and the episodes of diarrhea from each child in the household recorded. The rate of diarrhea between the groups will be compared. At the end of 9 months, households who were part of the standard habits and practice group will receive a water storage vessel and disinfectant.


Eligibility criteria: Inclusion Criteria:

* households in study neighborhoods
* contain a child \< 5 years old
* have access to water for handwashing

Exclusion Criteria:

* participated in handwashing or drinking water treatment programs with HOPE previously

Primary outcomes:
measure: diarrhea longitudinal prevalence
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Health-Oriented Preventive Education
Study officials:
References:
citation: Luby SP, Agboatwalla M, Painter J, Altaf A, Billhimer W, Keswick B, Hoekstra RM. Combining drinking water treatment and hand washing for diarrhoea prevention, a cluster randomised controlled trial. Trop Med Int Health. 2006 Apr;11(4):479-89. doi: 10.1111/j.1365-3156.2006.01592.x.
citation: Boudier E, Zurlinden B, Cour A, Rognon M, Devalland-Monnin C, Nirhy-Lanto A, el Khadissi H. [Antenatal diagnosis of achondrogenesis. Two successive cases in the same family]. J Gynecol Obstet Biol Reprod (Paris). 1991;20(5):623-6. French.
citation: Bowen A, Agboatwalla M, Luby S, Tobery T, Ayers T, Hoekstra RM. Association between intensive handwashing promotion and child development in Karachi, Pakistan: a cluster randomized controlled trial. Arch Pediatr Adolesc Med. 2012 Nov;166(11):1037-44. doi: 10.1001/archpediatrics.2012.1181.
Clinical trial NCT02680353: The Perioperative Analgesic Efficiency of Bilateral Superficial Cervical Plexus Block in Patients With Thyroidectomy
Official title: The Perioperative Analgesic Efficiency of Bilateral Superficial Cervical Plexus Block in Patients With Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Block
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2016-02-11
Enrollment: 47
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: To determine the postoperative analgesic efficiency of bilateral superficial plexus block, patients are divided into two groups. Study group received bilateral superficial plexus block, where control had none. Visual analog scale, opioid consumption and presence of nausea-vomiting are recorded.

Detailed description: Bilateral superficial cervical plexus block has successfully been demonstrated to provide an efficient analgesia in patients with thyroidectomy, parathyroidectomy, carotis end-arterectomy. The present study is aimed to investigate the intraoperative hemodynamic responses, anesthetic and analgesic consumption, and postoperative recovery quality of bilateral superficial cervical plexus block in patients with total thyroidectomy. After approval, patients enrolled in the study is invited to complete the Pain Catastrophizing Scale questionnaire. Patients are divided into two groups by computer-based randomization technique as control and study group. After standard monitorization, anesthesia induction and tracheal intubation, bilateral superficial cervical plexus block is performed to study group and no intervention to control group. At the end of the operation all patients received paracetamol 1 gr intravenous. In postoperative period, visual analog scale values, opioid consumption, presence of nausea-vomiting, anti-emetic usage or any other complications are recorded.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Planned to undergo thyroidectomy
* An American Society of Anesthesiologists score of 1 or 2

Exclusion Criteria:

* Severe cardiovascular disease
* Psychiatric diseases
* Difficult intubation
* Rejected to participation

Primary outcomes:
measure: Visual analog scale
timeFrame: one time in postoperative period for one year
Secondary outcomes:
measure: Presence of nausea-vomiting
timeFrame: In postoperative period for one year
measure: Mean arterial pressure
timeFrame: In both intraoperative and postoperative period for one year
measure: Heart rate
timeFrame: In both intraoperative and postoperative period for one year
measure: Antiemetic usage
timeFrame: postoperative period for one year
measure: respiratory rate
timeFrame: postoperative period for one year
measure: opioid consumption
timeFrame: During postoperative period for one year
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University
Study officials:
affiliation: Gaziosmanpasa University
name: Hakan Tapar, Assist.Prof
role: PRINCIPAL_INVESTIGATOR
References: