louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01896336: Efficacy and Safety of 5 mg Sublingual Zolpidem vs 10mg Oral Zolpidem in the Induction and Maintenance of Sleep in Patients With Primary Insomnia
Official title: National Study, Phase IV, Single-center, Double-blind, Randomized, Parallel, Controlled by 10 mg Oral Zolpidem, in Evaluating the Efficacy and Safety of Zolpidem 5 mg Sublingual in the Induction and Maintenance of Sleep in Patients With Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Insomnia
Lead sponsor: EMS
Sponsor class: INDUSTRY
Collaborators: name: Associação Fundo de Incentivo à Pesquisa
First posted: 2013-07-11
Enrollment: 67
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of sublingual zolpidem presentation 5 mg in the induction of sleep in patients with primary insomnia.

Detailed description: * National study, phase IV, single-center, double-blind, randomized, parallel, controlled by zolpidem 10mg oral.
* Experiment duration: 93 days.
* 05 visits (days -3, 0, 15, 45 and 90).
* Efficacy will be evaluated for: Sleep induction and the maintenance of sleep.
* Adverse events evaluation.

Eligibility criteria: Inclusion Criteria:

* Men or women aged between 20 and 64 years;
* Diagnosis of primary insomnia according to criteria defined by DSM-IV;
* Difficulty in maintaining sleep and waking up until 3 am;
* Not having used any psychoactive drug in the last 30 days prior to their inclusion in the study;
* Signature of IC.

Exclusion Criteria:

* Previous history of serious medical illness, neurological or psychiatric disorder;
* Allergy or hypersensitivity to zolpidem;
* Obstructive Sleep Apnea syndrome;
* Polysomnography with apnea and hypopnea index \>10/hour or PLM \>15/h;
* Other secondary sleep disorders;
* History of substance abuse or dependence;
* History of daily consumption of alcoholic beverages;
* Pregnancy, lactation or refusal to use safe contraceptive methods during the study.

Primary outcomes:
measure: Efficacy will be measured by sleep induction and maintenance.
timeFrame: 90 days
Secondary outcomes:
measure: Safety will be evaluated by the adverse events occurrences
timeFrame: 90 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: AFIP
state: Sâo Paulo
Study officials:
affiliation: Associacao Fundo de Incentivo a Psicofarmcologia
name: Dalva R Poyares, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Castro LS, Otuyama LJ, Fumo-Dos-Santos C, Tufik S, Poyares D. Sublingual and oral zolpidem for insomnia disorder: a 3-month randomized trial. Braz J Psychiatry. 2020 Apr;42(2):175-184. doi: 10.1590/1516-4446-2019-0389. Epub 2019 Dec 20.
Clinical trial NCT01467336: Supra-spinatus Rehabilitation Program Comparison
Official title: Prospective Randomized Study Comparing 3 Post-operative Rehabilitation Programs After Arthroscopic Supra-spinatus Tendon Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rotator Cuff Tear
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2011-11-08
Enrollment: 294
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Through a prospective randomized study the aims of this study is to analyze the impact of 3 types of rehabilitation protocols on the Optimization of the post-operative clinical and anatomic healing of the rotator cuff. After an arthroscopic repair of a stage 1 or 2 supra-spinatus tendon rupture, patients will be included in 3 groups (98 patients per group):

* strict immobilization for 6 weeks then active rehabilitation,
* or 3 weeks of immobilization then 3 weeks of passive motion before active rehabilitation,
* or immediate passive motion for 6 weeks and then active rehabilitation.

Patients will be evaluated clinically at 6 weeks, 3 months, 6 months and 1 year and an arthro-CT will be performed at 1 year.

The investigators will evaluate: constant score and rate of tendon healing.


Eligibility criteria: Inclusion Criteria:

* Male or female between 40 and 65 years old
* non-retracted supra-spinatus tendon tear-pre-operative clinical examination and ct
* scan-arthroscopic single-row tendon repair

Exclusion Criteria:

* patient with a stiff shoulder
* previous surgery of the shoulder
* stage 3 or 4 fatty infiltration
* insufficient repair of the cuff

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Illkirch
country: France
facility: CCOM, Service de Chirurgie du membre supérieur, Hôpitaux Universitaires de Strasbourg
city: Nancy
country: France
facility: Service d'Imagerie Guilloz, Hôpital Central, CHU de Nancy
city: Nancy
country: France
facility: Centre Chirurgical Emile Gallé
city: Strasbourg
country: France
facility: Service de radiologie, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg, France
name: Philippe CLAVERT, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03332836: Multiple Ascending Dose Study of HM12460A in Type 2 Diabetes Mellitus
Official title: A Phase 1, Multiple Ascending Dose, Glucose Clamp Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM12460A Compared to Insulin Glargine in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a phase 1 multiple ascending dose (MAD) study, conducted in subjects with Type 2 Diabetes Mellitus.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Female subjects must be non-pregnant and non-lactating

Exclusion Criteria:

* Recurrent severe hypoglycemia or hypoglycemic unawareness or recent severe ketoacidosis, as judged by the Investigator
* Pregnant or lactating women
* Participation in an investigational study within 30 days prior to dosing

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 1 month
Secondary outcomes:
measure: Cmax of HM12460A
timeFrame: 1 month
measure: AUC of HM12460A
timeFrame: 1 month
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Hanmi Investigative Site
state: California
Study officials:
References:
Clinical trial NCT01619436: The Effect of Clonidine in Glycemia During Coronary Artery Bypass Graft With Cardiopulmonary By-pass
Official title: The Effect of Clonidine in Glycemia During Coronary Artery Bypass Graft With Cardiopulmonary By-pass.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glycemia During Coronary Artery Bypass Graft
Sedation During Pre-anesthetic Medication
Lead sponsor: Federal University of Juiz de Fora
Sponsor class: OTHER
First posted: 2012-06-14
Enrollment: 46
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is the randomized blind research of the assessment of the different levels of glycemia during Coronary Artery Bypass Graft (CABG) with cardiopulmonary by-pass (CPB) between clonidine and placebo. As clonidine decrease the inflammatory response during cardiac surgery, the investigators would like to know if the glycemia levels in clondine group will be lower than placebo group.


Eligibility criteria: Inclusion Criteria:

* elective CABG EF \> 40% Sinus ritmy

Exclusion Criteria:

* precordialgia emergency surgery combinated surgery not agreement

Primary outcomes:
measure: sedation
timeFrame: 2 years
Secondary outcomes:
measure: Glycemia
timeFrame: 2 years
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: National institut of Cardiology
state: RJ
Study officials:
References:
Clinical trial NCT00397436: Pilot Study of Protein Profiling of the Human Epidermal Cells After Ultraviolet Irradiation
Official title: Pilot Study of Protein Profiling of the Human Epidermal Cells After Ultraviolet Irradiation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Proteomics
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2006-11-09
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main focus of this pilot study is to construct a fairly complete protein profile of the epidermis. This will allow us to study how the epidermis responds to external stressors such as ultra-violet. We hypothesize that by using the cutting edge technology, proteomics, we will be able to construct a fairly complete profile of different epidermal cells (keratinocytes, epidermal nerve fibers (ENFs), melanocytes, Langerhans cell,...etc) of normal and ultraviolet (UV) irradiated skin.

Detailed description: We will investigate the changes of the epidermal cell proteome after UV irradiation to the forearms of healthy young male volunteers. Knowledge of specific molecular markers may provide knowledge of basic biological systems and possibly targeted therapy of inflammation.

By using combined proteomic methodologies we will be able to quantify protein changes at cytoplasmic and membrane protein levels of epidermal cells in normal vs. irradiated skins.

This study may allow us to obtain fairly comprehensive profile of membrane integrated and cytoplasmic proteins of epidermal cell populations which will facilitate our understand of biological responses to UV irradiation.

Eligibility criteria: Inclusion Criteria:

* Healthy Males age 18-30
* Caucasian
* No neurological disease

Exclusion Criteria:

* Use of any medication that affects skin

Primary outcomes:
measure: Ability to quantify protein changes at cytoplasmic and membrane protein levels of epidermal cells in normal vs. irradiated skin
timeFrame: 1 year
Secondary outcomes:
measure: Obtain a profile of membrane integrated and cytoplasmic proteins of epidermal cell populations which will facilitate our understanding of biological responses to UV irradiation.
timeFrame: 1 year
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: George Wilcox, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03322436: HeartLinc, a Study With AMI Patients Undergoing PCI
Official title: A Non-interventional Patient Study to Demonstrate Medical Utility of the lncRNA to Predict HF in AMI Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: AMI Patients
Lead sponsor: Firalis SA
Sponsor class: INDUSTRY
First posted: 2017-10-26
Enrollment: 240
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: AMI patients undergoing PCI

Brief summary: HeartLinc is a non-interventional patient study to demonstrate medical utility of the lncRNA to predict HF in AMI patients. 300 patients are expected to be recruited.

Detailed description: The recruiting phase of the study includes the recruitment of patients (36 months) and is followed by 12 month of monitoring for each patient. After deciding MI and PCI treatment by physical exam, ECG and other diagnostic methods, blood samples will be collected. After undergoing PCI, samples of the same patients will be collected during hospitalization days after PCI (D0-3) according to the patient study flowchart. After hospitalization, patients will be contacted by phone call or written questionary after 30 days (D30). After 6 and 12 months, patients are reinvited for a routine rehospitalisation to perform clinical exams and ECGs. Blood and urine samples will be collected after 12 months.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years
* Myocardial infarction in association with a recent acute coronary syndrome \<24 hrs leading to a coronary angioplasty decision
* Myocardial infarction with ST-elevation (STEMI) or myocardial infarction following acute coronary syndrome without ST-segment shift with a significant elevation of non-ST troponin (NSTEMI)
* Participation in the Hearlink Cohort
* Collecting and signed informed consent for Heartlink study participation and consent to participate in the ancillary Heartlink 2 study

Exclusion Criteria:

* Sudden Cardiac arrest which resulted in resuscitation other than single, non-repeated electric shock,
* cardiogenic shock
* Severe extra-cardiac diseases involving the short-term life expectancy of patients (risk of death at one year
* Programmed major non-cardiac surgery
* Known Altered Left Ventricular function before Acute Coronary Syndrome inclusion
* History of left, right or global heart failure
* Significant heart failure at hospital admittance (KILLIP 2)
* Acute Coronary Syndrome know more than 24 hours
* History of Myocardial infarction
* Participation in any other in progress or stopped study for less than 3 months other than the Heartlink study

Primary outcomes:
measure: LV-EF < 40%
timeFrame: 12 months
Secondary outcomes:
measure: LVEDV
timeFrame: 12 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de TOULOUSE
city: Seoul
country: Korea, Republic of
facility: SNUH
Study officials:
affiliation: Firalis SA
name: Hüseyin FIRAT, MD, PhD,
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03348436: Study on Left Atrial Function of Paroxysmal Supraventricular Tachycardia After Radiofrequency Ablation
Official title: Study on Left Atrial Function of Paroxysmal Supraventricular Tachycardia After Radiofrequency Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Supraventricular Tachycardia
Keywords: paroxysmal supraventricular tachycardia
Left Atrial Function
Lead sponsor: The Second Hospital of Hebei Medical University
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 100 patients with persistent，in whom successful RF ablation of slow pathway or accessory pathway was performed. Patients with atrial fibrillation, structural heart disease, ventricular arrhythmias, impaired left ventricular systolic function or on antiarrhythmics were excluded. All the patients had echocardiographic study before ablation 、1 day and 1 months after ablation.
Primary purpose: TREATMENT

Brief summary: This study to investigate the effects of RF ablation on left atrial systolic function in patients with atrioventricular nodal reentrant tachycardia (AVNRT) and atrioventricular tachycardia (AVRT).

Detailed description: A total of 100 patients with persistent，in whom successful RF ablation of slow pathway or accessory pathway was performed. Patients with atrial fibrillation, structural heart disease, ventricular arrhythmias, impaired left ventricular systolic function or on antiarrhythmics were excluded. All the patients had echocardiographic study before ablation 、1 day and 1 months after ablation. Left atrial systolic function was assessed using atrial ejection force (AEF) according to Manning's formula (AEF = 0.5 x ρ x MA x A(2), r: blood density = 1.06 g/cm(3), MA: mitral orifice area \[cm(2)\], A: A wave velocity). The following left atrial dimensions were assessed: antero-posterior (LA-AP), infero-superior (LA-IS, long axis), medio-lateral (LA-ML, short axis). The correlations between AEF and electrophysiological parameters were analysed (VA - ventriculo-atrial conduction, VA/CL - tachycardia cycle length).

Eligibility criteria: Inclusion Criteria:

Patients with paroxysmal supraventricular tachycardia,includes atrioventricular reentrant tachycardia and atrioventricular nodal reentrant tachycardia， Age is \>14 years

Exclusion Criteria:

Atrial fibrillation, Atrial tachycardia， Structural heart disease, Ventricular arrhythmias, Patients with impaired left ventricular systolic function or on antiarrhythmics

Primary outcomes:
measure: Left Atrial Function of postoperative radiofrequency ablation.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
Study officials:
References:
Clinical trial NCT01328236: Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia
Official title: Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Plasma Cell Leukemia
Multiple Myeloma
Keywords: Bortezomib
PCL
Lead sponsor: Clinical Service, China
Sponsor class: INDUSTRY
Collaborators: name: Harbin Hematology and Oncology Institute
name: Shanghai Changzheng Hospital
name: Chinese PLA General Hospital
name: 307 Hospital of PLA
name: Wuhan Union Hospital, China
name: Beijing Chao Yang Hospital
name: Henan Provincial People's Hospital
name: Peking University Third Hospital
First posted: 2011-04-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Bortezomib/Liposomal doxorubicin (V-DD) is preferred to bortezomib single agent in salvage therapy for Multiple Myeloma (MM).

The present study is designed to assessment the efficacy and safety study of Bortezomib in combination with Liposomal Doxorubicin and Dexamethasone in treatment of Plasma Cell Leukemia (PCL).

Primary study endpoint is the overall response rate (sCR+CR+VGPR+PR). Secondary endpoints is the rate of complete response (sCR+CR), partial remission rate (VGPR + PR), duration of response (DOR), overall survival (OS).

Detailed description: Patient with Plasma Cell Leukemia(PCL ) and multiple myeloma (MM); KPS ≥ 60scores

Eligibility criteria: Inclusion Criteria:

* Patients confirmed relapsed or refractory PCL who previously untreated or never received treatment with Bortezomib
* KPS ≥ 60
* Adequate liver and renal function within 2 weeks of Screening:
* Bilirubin ≤ 1.5 × the upper limit of normal (ULN)
* Alanine aminotransferase (ALT) ≤ 2.5 × the upper limit of normal (ULN)
* Aspartate aminotransferase (AST) ≤ 2.5 × the upper limit of normal (ULN)
* Cardiac function \> Ⅲ grade and ejection fraction \> 45%
* Signed informed consent prior to initiation of any study-related procedures that are not considered standard of care

Exclusion Criteria:

* has taken Bortezomib
* KPS ≤ 60 scores
* mental illness

Primary outcomes:
measure: overall response rate
timeFrame: Day 1 of every treatment cycle
Secondary outcomes:
measure: the rate of response
timeFrame: Day 1 of every treatment cycle
measure: partial remission rate
timeFrame: Day 1 of every treatment cycle
measure: duration of response
timeFrame: up to 6 months
measure: overall survival
timeFrame: up to two and a half year
measure: Adverse Events
timeFrame: up to two and a half years
measure: FACT/GOC-Ntx
timeFrame: Day 1 of every treatment cycle
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Clinical Service Center
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: zhao wang, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04946136: Gait Modification and Knee Joint Load
Official title: The Effect of Gait Modification on Knee Joint Load in Persons With Medial Tibiofemoral Osteoarthritis - A Pilot Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 16
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This pilot study aims to assess the effect of a 6-week individualized gait retraining program on knee load and symptoms in persons with knee osteoarthritis (OA).

Detailed description: This study aims to pilot-test an individualized gait retraining intervention to reduce knee load, guided by real-time visual feedback of the external knee adduction moment (KAM), a commonly used determinant for medial tibiofemoral (TF) joint load, during walking. Our central hypothesis is that individuals with predominantly medial TF OA can adapt their gait patterns to lower KAM during walking; consequently, reduce knee load and pain.

Eligibility criteria: Inclusion Criteria:

* people with radiographic TF OA fulfilling American College of Rheumatology classification criteria
* reporting average knee pain on walking \> 3 on an 11-point scale (0-10) in at least one knee
* pain or tenderness predominantly located on the medial knee.

Exclusion Criteria:

* medial TF joint space width greater than lateral
* Kellgren/Lawrence (K/L) grade 4
* knee surgery or intra-articular corticosteroid injection in the past 6 months
* uncomfortable walking on treadmill for 20 minutes
* unable to walk without a walking aide
* inflammatory arthritis
* other musculoskeletal or neurological disorders that affect gait patterns
* currently receiving physical therapy

Primary outcomes:
measure: External knee adduction moment during walking
timeFrame: Baseline-to-6-week change
measure: WOMAC (Western Ontario and McMaster Universities) score
timeFrame: Baseline-to-6-week change
Secondary outcomes:
measure: External knee flexion moment during walking
timeFrame: Baseline-to-6-week change
measure: KOOS (Knee Injury and Osteoarthritis Outcome Score)
timeFrame: Baseline-to-6-week change
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Alison H Chang
role: PRINCIPAL_INVESTIGATOR
References: