louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01935167: To Determine the Efficacy and Safety of DW1029M on Microalbuminuria in Patients With Diabetic Nephropathy
Official title: A Phase Ⅱ, Prospective, 24 Weeks, Double-blind, Placebo-controlled, Randomized, Multi-center Clinical Trial for the Evaluation of the Efficacy and Safety of DW1029M on Microalbuminuria in Patients With Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Nephropathy
Keywords: Microalbuminuria
Lead sponsor: Dong Wha Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2013-09-04
Enrollment: 158
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 2 clinical study to evaluate of the efficacy and safety of DW1029M on microalbuminuria in Patients With Diabetic Nephropathy

Detailed description: A Phase Ⅱ, prospective, 24 weeks, double-blind, placebo-controlled, randomized, multi-center clinical trial for the evaluation of the efficacy and safety of DW1029M on microalbuminuria in Patients With Diabetic Nephropathy

Eligibility criteria: Inclusion Criteria:

* Has confirmed diabetic mellitus prior to 6years
* Has confirmed microalbuminuria 30 \~ 299㎍/㎎creatinine prior to 5months one time and microalbuminuria 30 \~ 299㎍/㎎creatinine during screening period
* Blood Pressure(BP) ≤ 150 / 90 mmHg
* estimated glomerular filtration rate(eGFR) ≥ 30 ml/min/1.73m2
* Hemoglobin A1c(HbA1c) ≤ 9%
* Low density lipoprotein(LDL-C) ≤ 130mg/dl

Exclusion Criteria:

* kidney or liver disease as follows i.Serum Creatinine \> 2.0mg/dl ii.Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) \> 2 x Upper Limit Normal(ULN) iii.Total Bilirubin \> 2 x ULN
* Organic gastrointestinal disorder or Chronic gastroenterologic disorders prior to 6 months as follows \[NOTE\] Active Crohn's disease, Active ulcerative colitis, Chronic peptic ulcer disease, etc.
* cardiovascular disease prior to 3 months as follows \[NOTE\] Unstable angina pectoris, Myocardial infarction, Coronary artery bypass surgery, Percutaneous Transluminal Coronary Angioplasty, transient ischemic attack, cerebrovascular accident etc.

Primary outcomes:
measure: log ACR
timeFrame: 24 weeks after 1st administration
Secondary outcomes:
measure: Log UAE
timeFrame: 24 weeks after 1st administration
measure: eGFR
timeFrame: 12 and 24 weeks after 1st administration
measure: log ACR
timeFrame: 12 weeks after 1st administration
measure: SCC
timeFrame: 12 and 24 weeks after 1st administration
measure: Cystatin C
timeFrame: 12 and 24 weeks after 1st administration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: DongWha Pharm
Study officials:
affiliation: Samsung Medical Center
name: MoonKyu Lee, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05501067: Tai Chi Training on Hand Grip Strength and Functional Fitness in Post COVID
Official title: A Tai Chi Training on Hand Grip Strength, Fatigue and Functional Fitness in Post COVID in Elderly Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Covid
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to evaluate the effects of participating of Tai Chi program on hand grip strength and Functional Fitness in post Covid

Detailed description: evaluate the effects of Tai Chi and aerobic training on improving hand grip strength, fatigue, and functional fitness in patients with post COVID-19.

Eligibility criteria: Inclusion Criteria:

* post covid

Exclusion Criteria:

* medically unstable
* post stroke
* obese
* mentally unstable

Primary outcomes:
measure: hand grip strength
timeFrame: 2 months
Secondary outcomes:
measure: functional fitness
timeFrame: 2 months
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: National institute for Gerontology
state: Bani Suwayf
Study officials:
affiliation: national institute for longevity elderly sciences, Beni Suef University, Egypt
name: mohammed elhamrawy, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00232167: Study Of Indiplon/Placebo With Sertraline In Insomnia Co-Existing With Depression
Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Tolerability Of Indiplon Therapy Initiated With Sertraline Versus Sertraline Monotherapy In Subjects With Insomnia And Co-Existing Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Insomnia
Depression
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
First posted: 2005-10-04
Enrollment: 380
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: The goal of this study is to determine whether indiplon, when administered with sertraline, improves insomnia symptoms and depressive symptoms in subjects with both insomnia and depression.

Detailed description: This Pfizer run study stopped due to the co-development program for indiplon being terminated between Pfizer and Neurocrine. The study was terminated on 16 November 2006. There were no safety issues leading to the decision to terminate this study.

Eligibility criteria: Inclusion Criteria:

* DSM-IV defined insomnia
* DSM-IV defined Major Depression

Exclusion Criteria:

* Current suicidal ideation or behavior
* Primary sleep disorder other than insomnia

Primary outcomes:
measure: Change from baseline to week 1 in subjective total sleep time (sTST); (average of the week one data)
Secondary outcomes:
measure: Change from baseline in subjective total sleep time (sTST). Change from baseline in subjective parameters: LSO, sWASO, sNAASO, Sleep Quality (IVR). Change from baseline in the 3-item HAM-D insomnia factor (items #4-6).
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00861367: Prospective Double-blind Study for the Use of Aspirin During Transurethral Surgery of the Bladder or the Prostate
Official title: Prospektive Doppel-Blind-randomisierte Studie Zur Verwendung Von Aspirin Bei Transurethralen Operationen
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Blood Loss, Surgical
Intraoperative Complications
Re-operation Rates in Patients With Aspirin Treatment
Keywords: aspirin
blood loss
transurethral surgery
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2009-03-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Aspirin is very common in older patients. Therefore many of the investigators patients have aspirin. The aim of the study is to proof that Transurethral Surgery of the bladder or the prostate can be performed with aspirin.


Eligibility criteria: Inclusion Criteria:

* Transurethral surgery of the bladder or prostate, informed consent, age over 18

Exclusion Criteria:

* Oral anticoagulation,

Primary outcomes:
measure: Blood loss
timeFrame: intraoperative, 6 hours post op, 3 days postop
Secondary outcomes:
measure: Reoperation rates
timeFrame: during hospitalization
Other outcomes:
Locations:
city: Liestal
country: Switzerland
facility: Urologische Universitätsklinik Basel-Liestal
Study officials:
affiliation: Department of Urology, Liestal
name: Thomas C Gasser, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT00779467: Epidural Neostigmine for Labor Pain
Official title: Epidural Neostigmine Dose Response for the Treatment of Labor Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Labor Pain
Keywords: non narcotic
epidural
labor pain
Non narcotic treatment of labor pain
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2008-10-24
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see which dose of epidural neostigmine is the best additive to use with the numbing medication used in an epidural during labor.

Detailed description: This study is examining the use of the non-narcotic medication, neostigmine, in combination with the local anesthetic bupivacaine when compared with the commonly used narcotic fentanyl in providing pain relief with the fewest side effects in labor analgesia.

Eligibility criteria: Inclusion Criteria:

* Healthy pregnancy
* Term pregnancy ( \> 37 weeks)
* Primiparous or multiparous
* Induction or spontaneous labor greater or = 18 years of age
* Cervical exam on entry \</=5 cm

Exclusion Criteria:

* Weight \> 115 kg
* Non-English speaking
* IV analgesics within 60 minutes prior to epidural being administered
* Allergy to local anesthetics or neostigmine

Primary outcomes:
measure: Amount of Drug Consumed Per Hour in Each Group(Arm)
timeFrame: until delivery
Secondary outcomes:
measure: Nausea
timeFrame: until delivery
measure: Sedation
timeFrame: until delivery
measure: Shivering
timeFrame: until delivery
measure: Pruritus
timeFrame: until delivery
measure: Bromage Score
timeFrame: until delivery
measure: Patient Satisfaction Scores
timeFrame: within 24 hours post delivery
measure: Cesarean Delivery
timeFrame: occurence
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences OB Anesthesia
name: Peter H Pan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00693667: Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women
Official title: A Phase II, Double-Blind, Randomized, Placebo-controlled, Clinical Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoporosis
Keywords: osteoporosis
postmenopausal women
botanical drug
Lead sponsor: PhytoHealth Corporation
Sponsor class: INDUSTRY
First posted: 2008-06-09
Enrollment: 92
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective of this clinical study is to evaluate the effectiveness and safety of PH3 for the prevention of osteoporosis.

The secondary objectives are to identify the optimal dosage for subsequent studies and to provide basis for the next confirmatory study in study design, endpoints, and study methodologies.


Eligibility criteria: Inclusion Criteria:

1. Women 40-60 years of age.
2. Must be postmenopausal (0.5\~5 years post cessation of menses) or ovariectomized or hysterectomy women who have documented elevated Follicle Stimulating Hormone FSH (\>30mIU/ml) with low serum estradiol (\<20 pg/ml).
3. The lumbar vertebral BMD T-score is between -1and -2.5 SD.
4. The body mass index (BMI) is between 19 and 29 kg/m2.
5. Completed informed consent and signed informed consent form.

Exclusion Criteria:

1. Have diseases which may affect bone metabolism, e. g., hyper-or hypocalcemia, hyperthyroidism, osteogenesis imperfecta, malignancy, chronic gastrointestinal disease, extensive Paget's disease, alcoholism, and renal or hepatic impairment.
2. Has taken drug therapy for osteoporosis within the previous six months (excluding calcium supplements) prior to this study.
3. Chronic or continued use of hormone replacement drugs or medications that may affect bone calcium metabolism, for example, phosphate-binding antacids, many diuretics, adrenal or anabolic steroids, heparin, anticonvulsants, fluoride in excess of 1 mg/day and supplements of vitamin D or A in excess of RDAs.
4. Vitamin D deficiency (1, 25-dihydroxyvitamin D is lower than the normal range of: 25.1 pg/mL \~ 66.1 pg/mL).
5. Patients with fracture history.
6. Patients who can not promise to keep from taking stimulant drinks (for example, coffee, tea, alcoholic drink, and Coke) that may cause loss of bone calcium, during the study period.

Primary outcomes:
measure: Biochemical Markers
timeFrame: four weeks
Secondary outcomes:
measure: Bone Densitometry
timeFrame: four weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veteran General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Hsiang Tai Chao, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05252767: Patient Engagement in Perioperative Pain Management Project
Official title: Evaluation of an Intervention for Improving Patient Engagement in Perioperative Pain Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Opioid Use Disorder
Keywords: Patient engagement
Patient activation
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2022-02-23
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Previously, the study team evaluated the implementation and effectiveness of the Johns Hopkins Perioperative Pain Program (PPP), which coordinates continuum of care for surgical patients on chronic opioid therapy throughout the perioperative period. Based on the findings of that project, the study team developed an educational intervention intended to improve patient engagement in perioperative pain management. In this project, the study team will formally implement a randomized controlled trial to evaluate the effectiveness of the intervention developed.


Eligibility criteria: Inclusion Criteria:

* All patients in Johns Hopkins Personalized Pain Program Clinic

Exclusion Criteria:

* Active suicidal ideation at study entry
* Primary psychotic disorder
* Non-English speaker

Primary outcomes:
measure: Patient engagement as assessed by a patient engagement survey
timeFrame: Time of each participant's standard of care clinic visit, up to 1 year from enrollment
Secondary outcomes:
measure: Opioid consumption as assessed by daily morphine milligram equivalents
timeFrame: Time of each participant's standard of care clinic visit, up to 1 year from enrollment
measure: Pain level as assessed by the Brief Pain Inventory
timeFrame: Time of each participant's standard of care clinic visit, up to 1 year from enrollment
measure: Pain level as assessed by the Present Pain Intensity scale of the McGill Pain Questionnaire
timeFrame: Time of each participant's standard of care clinic visit, up to 1 year from enrollment
measure: Pain level as assessed by the Pain Catastrophizing Scale
timeFrame: Time of each participant's standard of care clinic visit, up to 1 year from enrollment
measure: Functional status as assessed by the Insomnia Severity Index
timeFrame: Time of each participant's standard of care clinic visit, up to 1 year from enrollment
measure: Functional status as assessed by the 36-Item Short Form Health Survey
timeFrame: Time of each participant's standard of care clinic visit, up to 1 year from enrollment
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Anping Xie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002367: A Study of Saquinavir Soft Gelatin Capsules Plus Zidovudine Plus Lamivudine in the Treatment of HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs
Official title: An Open-Label, Non-Comparative Study of Saquinavir-SGC in Combination With Zidovudine (AZT) and Lamivudine (3TC) in the Treatment of HIV-1 Infected Patients With No Previous Anti-Retroviral Drug Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Zidovudine
HIV Protease Inhibitors
Lamivudine
Saquinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of Saquinavir-SGC combination with Zidovudine and Lamivudine in the treatment of HIV-1 infected patients with no previous anti-retroviral drug therapy.

Detailed description: All enrolled patients will receive the following 3 drug combination: Saquinavir, Zidovudine and Lamivudine. Efficacy and duration of anti-viral response will be evaluated by monitoring of HIV-1 RNA levels. Patients below the detectable limit of 200 copies/ml will be analyzed using the Ultra-direct method with a detection limit of 20 copies/ml. CD4 and CD8 cell counts will also be analyzed.

Eligibility criteria: Inclusion Criteria

Patients must have:

* Plasma HIV-1 RNA titers \> 10,000 copies/ml.
* CD4 cell count \> 100 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following conditions will be excluded:

* Any prior anti-retroviral drug therapy.

Prior Medication:

Excluded:

Previous anti-retroviral drug therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: AIDS Healthcare Foundation Labs
state: California
city: Fort Lauderdale
country: United States
facility: Urgent Care Ctr / North Broward Hosp District
state: Florida
Study officials:
References:
Clinical trial NCT02271867: Thermal QST for Interscale Block Evaluation
Official title: Thermal Quantitative Sensory Testing as a Method to Semi-quantitatively Assess the Neurosensory Effects of 3 Local Anesthetic Solutions in an Interscalene Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthetics, Local
Nerve Block
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Thermal quantitative sensory testing (QST) is a method to evaluate peripheral nerve blocks in a quantitative way. It assesses the neurosensory effects of local anesthetics, like nerve block intensity, duration, recovery, neurotoxicity, the effect of spread of local anesthetic solutions and the effect and the eventual neurotoxicity of adjuvants. We aimed at investigating, in a quantitative way, the block characteristics of 3 different commonly used local anesthetics on peripheral nerves through the application of thermal QST by measuring changes in sensory detection thresholds. Furthermore, we wanted to evaluate if QST could be of value for measuring gradual changes in block characteristics on the adjacent nerves at distance of the injection site in an US-ISB.


Eligibility criteria: Inclusion Criteria:

* Adult patients scheduled for diagnostic and therapeutic shoulder arthroscopy, with or without decompression technique were eligible

Exclusion Criteria:

* contraindications for ISB
* diabetes mellitus
* peripheral neuropathy
* patients receiving chronic analgesic therapy
* contraindications for NSAID
* patients with an initial QST with abnormal values

Primary outcomes:
measure: Presence of sensory block
timeFrame: 24 hours after intervention
Secondary outcomes:
measure: Degree of sensory stimulus detection threshold variation from baseline values
timeFrame: 24 hours after intervention
measure: Block duration
timeFrame: 24 hours after intervention
measure: Use of rescue medication
timeFrame: 24 hours after intervention
measure: Presence of motor block
timeFrame: 24 hours after intervention
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
References:
citation: Sermeus LA, Hans GH, Schepens T, Bosserez NM, Breebaart MB, Smitz CJ, Vercauteren MP. Thermal quantitative sensory testing to assess the sensory effects of three local anesthetic solutions in a randomized trial of interscalene blockade for shoulder surgery. Can J Anaesth. 2016 Jan;63(1):46-55. doi: 10.1007/s12630-015-0505-x. Epub 2015 Oct 16.
Clinical trial NCT06621667: Diaphragmatic Myofascial Release for Hyperkyphotic Subjects
Official title: Response of Lung Function, Chest Mobility, and Kyphotic Curve to Diaphragmatic Myofascial Release in Hyperkyphotic Subjects: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hyperkyphosis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: kyphotic subjects have respiratory disturbances due to weakening of the diaphragm, responsible for inhalation, which lead to abnormalities in respiratory mechanics and abnormal gas exchange, leading to respiratory complications. Myofascial release of the diaphragm is an intervention intended to indirectly stretch the diaphragm muscle fibers to reduce muscle tension, normalize fiber length, and promote the efficiency of muscle contraction. Although diaphragm myofascial release has been used in clinical practice, to the best of the authors' knowledge, the current study is the first research investigating the effect of diaphragmatic myofascial release on lung function, chest mobility and kyphotic curve in hyperkyphotic subjects.


Eligibility criteria: Inclusion Criteria:

* The participant's age ranged from 20 to 40 years.
* kyphosis angle 40-50◦
* reporting pain on palpation of the diaphragm

Exclusion Criteria:

* A history of respiratory diseases, heart disease, vascular disease, central nervous system disorder, psychiatric disorders, hypertension.
* History of any trauma or fracture to the thoracic spine.
* inflammatory diseases such as rheumatoid arthritis, musculoskeletal problem and neurological deficit
* Restrictive respiratory disease, smokers.

Primary outcomes:
measure: maximum voluntary ventilation
timeFrame: change from base line at 4 weeks.
Secondary outcomes:
measure: Chest expansion
timeFrame: change from base line at 4 weeks.
measure: kyphotic angle
timeFrame: change from base line at 4 weeks.
Other outcomes:
Locations:
Study officials:
References: