louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00997282: A Study of OPC-262 in Patients With Type 2 Diabetes
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, 3-arms Parallel Group Comparative Study of OPC-262 in Patients With Type 2 Diabetes (Phase 2/3 Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetes Type 2
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-10-19
Enrollment: 255
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to evaluate the superiority of the efficacy of OPC-262 (2.5 mg, and 5 mg) to placebo in patients with type 2 diabetes after 24 week treatment in a double-blind fashion and to evaluate the safety of OPC-262 to placebo.


Eligibility criteria: Inclusion Criteria:

1. Type 2 diabetes patients with HbA1C above 6.5% and below 10%
2. Patients who are capable of giving informed consent
3. Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after the study (end of the post-observation period)

Exclusion Criteria:

1. Patients with type 1 diabetes mellitus, patients with diabetes mellitus due to other specified drugs, mechanisms or diseases, and patients with gestational diabetes mellitus
2. Patients with a medical history of diabetic coma
3. Patients with poorly-controlled hypertension
4. Patients with heart failure
5. Patients with a complication of active hepatitis or hepatic cirrhosis
6. Patients undergoing treatment of glomerular diseases other than diabetic nephropathy
7. Patients with a history or complication of malignant tumor

Primary outcomes:
measure: Changes in HbA1C from baseline
timeFrame: Week 24 (LOCF)
Secondary outcomes:
measure: Changes in fasting blood glucose (FBG) from baseline
timeFrame: Week 24
measure: Changes in 2 hour postprandial blood glucose (PPG) from baseline
timeFrame: Week 24
measure: Changes in 3 hour PPG AUC from baseline
timeFrame: Week 24
Other outcomes:
Locations:
city: Chubu Region
country: Japan
city: Chugoku Region
country: Japan
city: Kansai Region
country: Japan
city: Kanto Region
country: Japan
city: Kyushu Region
country: Japan
city: Shikoku Region
country: Japan
city: Tohoku Region
country: Japan
Study officials:
affiliation: OPCJ
name: Kaatsuhisa Saito
role: STUDY_CHAIR
References:
Clinical trial NCT02744482: Efficacy of Risedronate in Patients With Painful Periprosthetic Resorption of the Hip Prothesis
Official title: Efficacy of Risedronate in Patients With Painful Periprosthetic Resorption of the Hip Prothesis Double-blind Randomized Study Versus Placebo
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Prosthesis Loosening
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 3
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: This is an experimental study, prospective, comparative. This clinical trial is randomized and double-blind, Residronate versus placebo.

The study aims to demonstrate the effectiveness of risedronate in pain management, after 18 month of traitment, in patients undergoing aseptic joint prosthesis loosening. 2 groups were compared with a 1: 1 ratio. The first group receives active drug (risedronate 75mg) and the second a placebo.

Patients are treated during 18 months: 1 tablet residronate/placebo per os two consecutive days each month.

Evaluations are planned evry 6 months.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects, 18 years of age or older.
* Written informed consent
* Subjects with cemented or not cemented total hip prothesis (for primitive or secondary coxarthrosis)
* Painful aseptic loosening
* Subject has pain 4 or greater on a 10 point Visual Pain Rating scale
* For subject woman of reproductive age, they must use reliable method(s) of contraception and/or abstinence, for the duration of therapeutic product exposure.

Exclusion Criteria:

* Subjects with septic loosening of hip prosthesis

  . Subjects with bilateral disease
* Subjects with implant mobility associated with pre-operative and intraoperative loosening
* Subjects under anti-osteoporotic treatment
* Subjects having stopped a biphosphonate traetment for less than one year
* Subjects with known allergy or sensitivity to any of the components in the study medication.

  * Subjects with Hypocalcemia
  * Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
  * Subjects with severe kidney failure ( creatinine \< 30 ml/min)).
  * Subjects participation in another research study
  * Subjects with previous osteonecrosis of the jaw

Primary outcomes:
measure: Pain measurement
timeFrame: 18, months
Secondary outcomes:
measure: Pain measurement at walk
timeFrame: 6 months, 12 months, 18, months, 24 moths
measure: Pain measurement at rest
timeFrame: 6 months, 12 months, 18, months, 24 moths
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU Limoges
Study officials:
References:
Clinical trial NCT00685282: The Effect of Stress on DNA Integrity and the Effect of Cognitive Behavioral Therapy on Stress and Infertility in Women
Official title: The Effect of Stress on DNA Integrity and the Effect of Cognitive Behavioral Therapy on Stress and Infertility in Women Undergoing IVF Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Stress
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
Collaborators: name: Ben-Gurion University of the Negev
First posted: 2008-05-28
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The general hypothesis of the research is that stress decreases fertility and that Cognitive Behavioral Therapy will reduce stress and increase fertility. Secondarily, we hypothesize that stress has a detrimental effect on DNA integrity and that stress reduction will reduce DNA damage in the cell.


Eligibility criteria: Inclusion Criteria:

* women between the ages of 18-35 without children undergoing IVF treatment

Exclusion Criteria:

* undergoing treatment for a DSM-IV axis I psychiatric illness.

Primary outcomes:
measure: pregnancy
timeFrame: two years
Secondary outcomes:
measure: DNA damage/ γH2AX
timeFrame: with in IVF cycle (2 months)
measure: decreased stress
timeFrame: two months
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: IVF Clinic Soroka UMC
Study officials:
affiliation: Soroka UMC
name: Eitan Lunenfeld, PHD MD
role: STUDY_CHAIR
affiliation: Ben-Gurion University of the Negev
name: Julie Cwikel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ben-Gurion University of the Negev
name: Orly Sarid, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Soroka UMC
name: Iris Harvardi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00882882: To Demonstrate the Relative Bioavailability of Metformin HCL 500 mg Extended Release (XR) Tablets Under Fasting Conditions
Official title: A Relative Bioavailability Study of Metformin HCL 500 mg XR Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type II Diabetes
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-04-17
Enrollment: 16
Sex: ALL
Minimum age (years): 19
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability of Metformin HCl 500 mg XR tablets under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 23 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novum Independent Institutional Review Board
name: So Ran Hong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01086982: Pharmacodynamics Of Product Octreotide Acetate Lar 30 Mg Compared To Product Sandostatin LAR ®
Official title: Pharmacodynamics Of Product Octreotide Acetate Lar 30 Mg, Imported And Distributed By The Laboratory Chemical Pharm. Bergamo, Compared To Product Sandostatin LAR®30 MG Manufactured By Novartis Biosciences S/A
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Acromegaly
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
First posted: 2010-03-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Check the pharmacodynamics of the drug octreotide acetate LAR 30 mg imported and distributed by Chemical Laboratory Pharmaceutical Bergamo Ltda. compared to the drug Sandostatin LAR ® (octreotide acetate 30 mg) manufactured by Novartis Biociências S / A, using as activity analysis of growth hormone (GH) and growth factor insulin-like 1 (IGF-1 ) after a single dose of the drug in patients with acromegaly

Detailed description: Secondly, it will be observed safety (tolerability) in clinical patients by comparing the clinical and laboratory parameters before and after the study and the incidence of adverse events after a single dose

Eligibility criteria: Inclusion Criteria:

- Accept the Terms of Consent;

* be aged over 18, regardless of sex;
* Patients with acromegaly who presented GH levels ≥ 2.5 ng / mL or no suppression of GH levels to less than 1 ng / mL after tolerance test glucose and IGF-I levels for age and sex;
* Patients undergoing hypophysectomy followed by radiotherapy or not and to keep níves increased GH and IGF-I;
* Patients waiting hypophysectomy with increased levels of GH and IGF-I

Exclusion Criteria:

* Have participated in any experimental study or have ingested any drug trial within six months prior to the start of the study;
* Have made use of medications that influence the results, regular 4 weeks prior to the start of the study or having used any medication a week before the start of the study;
* Have been treated with somastostatina analog or dopamine agonist in the last 2 months;
* Present history of myocardial infarction, angina and / or heart failure;
* Patients who present calculation of the gallbladder and have not undergone cholecystectomy;
* Pregnant women and nursing;
* Patients who have allergies to medicine;
* Patients with a history of acute pancreatitis;
* Patient with altered levels of amylase

Primary outcomes:
measure: Quantification of serum levels of GH and IGF-I.
timeFrame: Before drug administration, after drug administration, 1, 3, 7, 14, 21, 28, 35, 42, 49, 56 and 63 days after.
Secondary outcomes:
measure: Occurrence and severity of side effects during use of the product in order to ensure the security of it.
timeFrame: After drug administration, 1, 3, 7, 14, 21, 28, 35, 42, 49, 56 and 63 days after.
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: LAL Clínica Pesquisa e Desenvolvimento Ltda
state: São Paulo
Study officials:
References:
Clinical trial NCT04459182: Circulating Exosomes and Endothelial Dysfunction in Patients With Obstructive Sleep Apneas Hypopneas Syndrome
Official title: Circulating Exosomes and Endothelial Dysfunction in Patients With Obstructive Sleep Apneas Hypopneas Syndrome(OSA): EXODYS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Dysfunction
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2020-07-07
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Evaluation of miRNA contained in exosomes in obese and OSA patients with endothelial dysfunction evaluated by digital plethysmography (ENDOPAT) compared to obese and OSA patients without endothelial dysfunction.

Detailed description: The aim of the study is to compare the content of exosomes between two goups of 20 patients, with and without endothelial dysfucntion.

the endothelial function will be evaluated after polysomnography, on obese patients with OSA (AHI \>15).

Eligibility criteria: Inclusion Criteria:

* adult subject
* Subject understands the study protocol and is willing and able to comply with study requirements and sign informed consent
* Subject with OSA (defined by AHI \>15/h)

Exclusion Criteria:

* cardiac or vascular desease

Primary outcomes:
measure: miRNA cointained in exosomes
timeFrame: immediately after the consultation
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Frédéric GAGNADOUX
Study officials:
affiliation: University Hospital, Angers
name: GAGNADOUX Frédéric, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01007682: Intrusive Reexperiencing: The Role of Working Memory Capacity and Thought Suppression
Official title: Intrusive Reexperiencing: The Role of Working Memory Capacity and Thought Suppression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Memory
Keywords: intrusive memories
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2009-11-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims at identifying risk factors for the development of intrusive reexperiencing symptoms. In particular, the investigators examine the influence of working memory capacity and thought suppression on the occurrence of unpleasant memories of a negative experience.

Hypothesis: People with high working memory capacities (HWMC) are able to successfully suppress memories of an unpleasant experience (presentation of a distressing movie). In contrast, in people with low working memory capacities (LWMC), attempts to suppress memories of an unpleasant experience inadvertently lead to an increase of these memories.

Study phase one: Assessment of working memory capacity in 200 healthy participants by means of a computerized task. Selection of 50 participants with HWMC and of 50 participants with LWMC who participate in study phase two.

Study phase two: Presentation of a distressing movie and subsequent assessment of memories of the movie during several days in the daily life of participants. Comparison of 4 groups regarding the frequency of instructions in daily life:(group 1: HWMC participants who are instructed to suppress thoughts of the movie, group 2: LWMC participants who are instructed to suppress thoughts of the movie, group 3: HWMC participants who are instructed to allow the occurence of thoughts of the movie, group 4: LWMC participants who are instructed to allow the occurence of thoughts of the movie)


Eligibility criteria: Inclusion Criteria:

* Older than 17 years

Exclusion Criteria:

* Insufficient knowledge of the German language, for the distressing movie arm of the study: Elevated levels of depression or posttraumatic stress symptoms prior to viewing of the distressing movie

Primary outcomes:
measure: Number of intrusive memories
timeFrame: during one week after viewing the distressing movie
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Harvard University, Department of Psychology
state: Massachusetts
Study officials:
affiliation: Harvard University, Department of Pysychology
name: Monique C Pfaltz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Basel, Department for Clinical Psychology and Psychotherapy
name: Jürgen Margraf, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT02357082: Mayo Clinic Cardiac Implantable Electronic Device MRI Registry
Official title: Mayo Clinic Cardiac Implantable Electronic Device (CIED) Magnetic Resonance Imaging (MRI) Registry; Determining the Risks of of MRI in the Presence of Cardiac Implantable Electronic Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Magnetic Resonance Imaging
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-02-06
Enrollment: 1000
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 at Mayo Clinic who have a previously implanted CIED and are scheduled for a clinically-indicated MRI will be included in the registry.

Brief summary: Registry intends to prospectively collect data regarding the safety of magnetic resonance imaging (MRI) studies in patients with cardiac pacemakers on implantable cardioverter defibrillators.


Eligibility criteria: Inclusion Criteria:

* Strong clinical indication for MRI; in the clinical setting where MRI is the diagnostic modality of choice for a specific disease state without acceptable alternative imaging technology
* Male or Female
* 18 years of age or older
* Able to provide informed consent
* Presence of CIED

Exclusion Criteria:

* Presence of metallic objects that represent a contraindication to MR imaging, including: MRI-unsafe intra-orbital or intra-ocular retained metal fragments, and MRI-unsafe intracranial vascular clips and coils, other MRI-unsafe devices
* Morbid obesity (abdominal diameter greater than 60 centimeters) which results in contact wiht the magnet bore.
* Pregnant at time of scanning Pacemaker or Implanted Cardiac Device that is labeled as MRI-Conditional (approved by the Food and Drug Administration for exposure to MRI)
* Pacemaker dependent and either: 1) device implanted before 2005, or 2) advisory pulse generator that may lower outputs in the setting of radiofrequency currents

Primary outcomes:
measure: Cardiac Implantable Electronic Device Lead Impedance at Different Timepoints
timeFrame: Baseline, Visit 1, 3 months, 6 months
measure: Cardiac Implantable Electronic Device Lead Threshold at Different Timepoints
timeFrame: Baseline, Visit 1, 3 months, 6 months
measure: P/R Wave Amplitude at Different Timepoints
timeFrame: Baseline, Visit 1, 3 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Paul A Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01421082: Evaluation of Physiologic Parameters to Study the Mechanism of Action of the Lung Volume Reduction Coil in Subjects With Homogeneous Emphysema
Official title: Evaluation of Physiologic Parameters to Study the Mechanism of Action of the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) in Subjects With Homogeneous Emphysema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Emphysema
Keywords: LVRS (Lung Volume Reduction Surgery)
LVRC (Lung Volume Reduction Coil)
Emphysema
coil
RePneu
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: PneumRx, Inc.
First posted: 2011-08-22
Enrollment: 10
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The PneumRx Lung Volume Reduction Coil (LVRC) has been shown to effectively improve quality of life, exercise capacity, and static lung volumes, in patients with emphysema. The mechanism of action for these effects is believed to be related to the restoration of elastic recoil to lung parenchyma that has been damaged by emphysema. The objective of this study is to evaluate several physiologic parameters which should provide measures directly related to the mechanism of action by which the coils produce these outcomes.


Eligibility criteria: Inclusion Criteria:

Subject \> 35 years of age CT scan indicates homogeneous emphysema Subject has stopped smoking for a minimum of 6 months prior Subject (and legal guardian if applicable) read, understood and signed the Informed Consent form

Exclusion Criteria:

Subject has a history of recurrent clinically significant respiratory infection Subject has uncontrolled pulmonary hypertension Subject has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc Subject is pregnant or lactating Subject has an inability to tolerate bronchoscopy Subject has clinically significant bronchiectasis Subject has giant bullae Subject has had previous LVR surgery, lung transplant or lobectomy Subject has been involved in other pulmonary drug studies with 30 days prior Subject has other condition that would interfere with completion of study, follow up assessments or that would adversely affect outcomes

Primary outcomes:
measure: 6 minute walk test (6MWT)
timeFrame: 6 months
Secondary outcomes:
measure: Adverse Events
timeFrame: 6 months
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen - UMCG
state: The Netherlands
Study officials:
References:
Clinical trial NCT00864682: Preventing Propofol-associated Injection Pain
Official title: Propofol Mixed With Lidocaine Versus Lidocaine Pretreatment With Tourniquet for Alleviation of Pain Associated With Propofol Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: propofol
lidocaine
injection pain
Lead sponsor: Benaroya Research Institute
Sponsor class: OTHER
First posted: 2009-03-19
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Injection of propofol is associated with discomfort in subsets of patients. Local anesthetics have been shown to attenuate this response in some patients. This randomized, double-blind, placebo-controlled trial tests the hypothesis that lidocaine mixed with propofol will be superior to lidocaine administered directly into the vein, under tourniquet control, prior to injection of propofol. Both groups are expected to be superior to placebo.


Eligibility criteria: Inclusion criteria:

* weight \>40kg, \<100kg
* ambulatory surgery

Exclusion criteria:

* allergy to propofol or lidocaine
* taking opioids, benzodiazepines, or nonsteroidal antiinflammatory drugs (NSAIDs)

Primary outcomes:
measure: Verbal Pain Score
timeFrame: Immediately after injection of study drug. One time assessment.
Secondary outcomes:
measure: Complete Alleviation of Injection Pain
timeFrame: Immediately after injection of study drug. One time assessment
measure: Satisfaction With Anesthetic Technique
timeFrame: Prior to discharge. One time assessment
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Benaroya Research Institute
state: Washington
Study officials:
affiliation: Virginia Mason Medical Center
name: Joseph M Neal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walker BJ, Neal JM, Mulroy MF, Humsi JA, Bittner RC, McDonald SB. Lidocaine pretreatment with tourniquet versus lidocaine-propofol admixture for attenuating propofol injection pain: a randomized controlled trial. Reg Anesth Pain Med. 2011 Jan-Feb;36(1):41-5. doi: 10.1097/AAP.0b013e31820306da.