louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03254914: Fimasartan Optimal Reduction Targeting Elevated Blood Pressure: the FORTE Study
Official title: A Multi-center, Cluster-randomized, Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Home Blood Pressure
Fimasartan
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2017-08-21
Enrollment: 3554
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypertensive patients

Brief summary: The purpose of this study is to evaluate the effect of home blood pressure monitoring on controlling blood pressure and correlation between home blood pressure and clinic blood pressure in hypertensive patients receiving two or more concomitant antihypertensive agents including fimasartan

Detailed description: A multi-center, cluster-randomized, prospective, observational study

Eligibility criteria: Inclusion Criteria:

* Subjects who voluntarily signed informed consent for participating in this clinical study
* Male and female over the age of 19
* Hypertensive patients receiving two or more concomitant anti-hypertensive agents including fimasartan

Exclusion Criteria:

* Renal dialysis patients.
* Diabetic nephropathy patients taking angiotensin-converting enzyme inhibitor.
* Severe renal disorder
* Subjects with hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
* Medical history with hypersensitivity to Fimasartan
* Pregnant women or lactating female.
* Participate in another clinical trial.

Primary outcomes:
measure: Rate of reaching target blood pressure
timeFrame: 12 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
References:
citation: Choi JY, Kim KI, Kim CH. Effect of home blood pressure monitoring for blood pressure control in hypertensive patients taking multiple antihypertensive medications including fimasartan (the FORTE study). Clin Hypertens. 2020 Dec 15;26(1):24. doi: 10.1186/s40885-020-00154-y.
Clinical trial NCT00240214: Study Evaluating Rapamune in Patients After Kidney Transplantation
Official title: An Open Label Post Marketing Surveillance Assessment to Evaluate the Effectiveness and Safety of Rapamune in Patients After Kidney Transplantation Receiving a Rapamune Containing Regime
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Renal Transplantation
Keywords: Kidney transplants
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-17
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The purpose of this study is to obtain data on the effectiveness and safety of Rapamune under everyday conditions


Eligibility criteria: Inclusion Criteria:

* Patients having received a renal allograft from a cadaveric or living donor with low or moderate risk of developing acute rejection episodes.

Exclusion Criteria:

* Contraindications according to Summary of the Product Characteristics (SmPC).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Cities
country: Germany
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Germany, medinfoDEU@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05047614: Effects of Lumbar Repositioning Feedback and Transversus Abdominis Training on Lumbar Propricption in Patients With Chronic Mechanical Low Back Pain
Official title: Effects of Lumbar Repositioning Feedback and Transversus Abdominis Training on Lumbar Propricption in Patients With Chronic Mechanical Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthopedic Disorder
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 48
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study is conducted to answer the following question: What is the effect of lumbar repositioning feedback and transverses abdominis training on lumbar proprioception in patients with chronic mechanical low back pain?

Detailed description: Chronic low back pain is a chronic pain syndrome in the lower back region, lasting for at least twelve weeks. Chronic low back pain represents the leading cause of disability worldwide and is a major welfare and economic problem. Low back pain represents a major social and economic problem. The prevalence of chronic low back pain is estimated to range from fifteen to forty-five percent in French healthcare workers. Low back pain symptoms can derive from many potential anatomic sources, such as nerve roots, muscle, fascial structures, bones, joints, intervertebral discs, and organs within the abdominal cavity. Moreover, symptoms can also spawn from aberrant neurological pain processing causing neuropathic low back pain. Low back pain has been associated with motor control dysfunction. Indicators of this dysfunction include decreased contraction of the transversus abdominis and multifidus muscles, the reduced cross-sectional area of the multifidus, and fat infiltration. An association of chronic low back pain with altered muscle recruitment patterns and transversus abdominis activation delay was also found, as well as increased back muscle fatigue and altered kinematic patterns in the hips and lumbar area.

This was further supported in two recent systematic reviews that reported that proprioception deficits were found in patients with chronic low back pain compared to healthy controls

Eligibility criteria: Inclusion Criteria:

* Patients with CMLBP referred from orthopedic surgeon with no radicular pain
* Their age is ranged between 35-55 years old (Martim etal.,2008)
* BMI 24-28 kg/m2

Exclusion Criteria:

* Patients who have a history of diabetic peripheral neuropathies
* Patients who have a history of sciatica
* Spinal or lower limb deformity or any pathology within the spine.
* Patients who have neurological disorders
* Patients who have a history of previous lumbar surgery
* Patients who have visual problems

Primary outcomes:
measure: Pressure biofeedback unit
timeFrame: up to 45 days
measure: feedback laser tracker
timeFrame: up to 45 days
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: October 6 university
Study officials:
References:
Clinical trial NCT00000214: IV Cocaine Abuse: A Laboratory Model - 3
Official title: IV Cocaine Abuse: A Laboratory Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: intravenous abuse
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Columbia University
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of buprenorpine on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving in non-opiate dependent cocaine users.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Direct cocaine effects (caridio, subjective)
measure: Interaction of coc/bup on cardio measures
measure: Ineraction of coc/bup on coc's subjective effects
measure: Effects of buprenorphine on cocaine craving
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Richard Foltin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Behav Pharm 1994, vol 5: 79-89
Clinical trial NCT03978195: A Non-invasive Device to Remove Fluid From the Middle Ear
Official title: EMD - A Non-invasive Device for Ventilating the Middle Ear Feasibility Study to Evaluate Efficiency and User Satisfaction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Otitis Media With Effusion
Lead sponsor: Yuinvent Innovations Ltd.
Sponsor class: INDUSTRY
First posted: 2019-06-07
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A feasibility study for evaluating efficacy and satisfaction is treated using a non-invasive device for middle ear ventilation.

The study is designed to test the device's effectiveness by encouraging the evacuation of fluid from the middle ear, aid in hearing improvement, pain relief and assessment of patient satisfaction with the use of the device.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with ear fluids (OME) according to a doctor's examination for at least 4-6 weeks. There is a progressive hearing impairment and a matching tympanum.
* In principle, these children (with OME and hearing impairment) meet the criteria and candidates for the analysis of inserting tubes of incontinence (buttons).

Exclusion Criteria:

* First encounter: acute ear infection or Proper Otoscopy
* Second session: First review: Otoscopy / Timpneometry / Hearing test.
* Parallel treatment: acupuncture - tubes insertion - discontinuation of follow-up - cessation of the experiment initiated by parents

Primary outcomes:
measure: Middle ear values of Tympanometry
timeFrame: 10 weeks
measure: Middle ear ventilation evaluated by otoscopy
timeFrame: 10 weeks
Secondary outcomes:
measure: Auditory test
timeFrame: 10 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02369055: Quality of Life and Rehabilitation Pathway in Northern Norway and Denmark.
Official title: Relationship Between Quality of Life and Rehabilitation Pathway One Year Post Stroke in Northern Norway and Denmark. A Mixed Method Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Quality of Life
Keywords: Rehabilitation
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2015-02-23
Enrollment: 369
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: All patients with stroke

Brief summary: The aim of this study is to analyze and describe rehabilitation pathways of stroke patients in a region of North Norway and Central Denmark Region in relation to how patients perceive quality of life, health and functioning one year post stroke.

The study will consist of 1) Translate, cross-cultural adapt and validate a stroke-specific health-related questionnaire 2) Describe the level of quality of life and rehabilitation pathway in the two countries 3) In-depth interviews of a smaller group of patients for a more complex understanding

The study is part of a larger prospective observational multicenter-study of two patient cohorts with stroke.

Detailed description: Anticipated: 500 patients from Norway and 500 patients from Denmark are included in the national stroke-register datasets, and 250 patients from each country in the questionnaire-based datasets.

The questionnaire includes demographic data, the Stroke-Specific Quality of Life (SS-QOL) scale, Hospital Anxiety and Depression Scale (HADS), The EuroQol Quality of Life scale (EQ-5D), the EuroQol Visual Analogue Scale (EQ-VAS), the Quality of Life After Brain Injury, Overall Scale QOLIBRI-OS, modified Rankin Scale (mRS), and additional questions about satisfaction on treatment and rehabilitation.

5-6 patients from each country will be selected for semi-structured interviews with both priori questions and exploratory questions.

The mixing of methods will balance the goals of generality and complex understanding in how patients describe their quality of life and rehabilitation-chain.

Eligibility criteria: Inclusion Criteria:

All patients admitted to the hospitals; UNN Tromso,Harstad, Narvik (Norway) and Aarhus (Denmark).

Exclusion Criteria:

Unverified stroke and residence outside of the studyregion.

Primary outcomes:
measure: Health-Related Quality of Life
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: Universitetet i Tromsø, Norges Arktiske Universitet, Det helsevitenskapelige fakultet, Institutt for helse og omsorgsfag
Study officials:
affiliation: Division of Rehabilitation Services, University Hospital of North
name: Audny Anke, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03461055: Lavender During Intrauterine Insemination
Official title: Lavender Aromatherapy vs Placebo to Decrease Anxiety and Pain During Intrauterine Insemination (IUI).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
Anxiety
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Researchers hope to learn if by using lavender aromatherapy during an intrauterine insemination patients have decreased anxiety and pain at the time of the procedure.

Detailed description: Infertility patients have a high level of anxiety before and during infertility treatments due to anticipated discomfort of a procedure and anticipation of a long awaited pregnancy. Aromatherapy with lavender, an essential oil, has been shown to be effective in reducing anxiety and pain in a variety of procedures such as Botox injections, cesarean delivery and intrauterine device placement.

Eligibility criteria: Inclusion Criteria:

* Women undergoing intrauterine insemination
* English speaking

Exclusion Criteria:

* Allergy to lavender oil or its components
* Currently using aromatherapy
* Contraindication to intrauterine insemination
* Contraindication to pregnancy

Primary outcomes:
measure: Anxiety
timeFrame: During intrauterine insemination procedure
Secondary outcomes:
measure: Pain
timeFrame: During intrauterine insemination procedure
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Elizabeth Stewart, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04763655: Neural Biomarkers of Electroconvulsive Therapy Response
Official title: Neural Biomarkers of Electroconvulsive Therapy Response in Schizophrenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Electroconvulsive Therapy Treated Patients
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2021-02-21
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In the proposed study, the investigators will utilize resting-state functional MRI (fMRI) and structural MRI-based electrical field modeling to study the effect of electroconvulsive therapy on human neural circuitry. Our study will recruit patients who are beginning treatment with bilateral electroconvulsive therapy (N=75). Our design will be longitudinal where patients will be followed up until their 8th week electroconvulsive therapy clinically. The primary measure of interest will be the slope of clinical change estimated with mixed effect modeling (see Approach). Secondary measures will be the cognitive performance change between baseline and the 8th week electroconvulsive therapy time point.


Eligibility criteria: Inclusion Criteria:

1. current positive symptoms rated ≥4 (moderate) on one or more of these BPRS 53 items: hallucinatory behavior, unusual thought content, suspiciousness, conceptual disorganization;
2. has failed at least one trial of treatment with antipsychotic drug, lasting 6 weeks in duration,
3. competent and willing to sign informed consent;
4. for women, negative pregnancy test and agreement to use a medically accepted birth control method; and
5. Diagnostic and Statistical Manual (DSM)-IV diagnosis of schizophrenia, schizoaffective or schizophreniform disorder.

Exclusion Criteria:

1. serious neurological or endocrine disorder;
2. any medical condition which requires treatment with a medication with psychotropic effects;
3. significant risk of suicidal or homicidal behavior;
4. cognitive (MMSE ≤ 23) or language limitations that would preclude subjects providing informed consent;
5. contraindications to treatment with electroconvulsive therapy;
6. contraindications to magnetic resonance imaging (e.g. pacemaker)

Primary outcomes:
measure: Rate of Response to Brief Psychiatry Rating Scale (BPRS)
timeFrame: Baseline and 8 weeks.
Secondary outcomes:
measure: The change of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)
timeFrame: Baseline and 8 weeks.
measure: Volume change of the hippocampus bilaterally based on MRI based volumetry
timeFrame: Baseline and 8 weeks.
measure: Magnitude of the electric field in the hippocampus bilaterally
timeFrame: At baseline.
Other outcomes:
Locations:
city: Glen Oaks
country: United States
facility: The Zucker Hillside Hospital
state: New York
Study officials:
affiliation: The Zucker Hillside Hospital
name: Miklos Argyelan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00998855: Glucose and Lipid Metabolism in Adolescents
Official title: Glucose and Lipid Metabolism in Adolescents
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Exercise
Obesity
Insulin Sensitivity
Keywords: Exercise in obesity
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2009-10-21
Enrollment: 42
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sedentary, post pubertal, Hispanic lean and obese adolescents

Brief summary: A 12 wk aerobic exercise program will reduce visceral, hepatic and intramyocellular fat accumulation and improve insulin sensitivity and glucose metabolism in obese sedentary Hispanic adolescents.

Detailed description: Lean and Obese post pubertal adolescents perform an aerobic exercise program 30 minx4/week at a heart rate corresponding to at least 70% of that obtained at VO2 peak. The exercise program is preceded and followed by a 7 d diet delivered by the metabolic research kitchen (identical on both study occasions); metabolic studies (identical on both study occasions) including 24h calorimetry, measurements of glucose and lipid metabolism and insulin sensitivity and secretion using compounds labelled with stable i.e. non radioactive isotopes and gas chromatography-mass spectrometry.Fat mass and lean body mass are measured by DXA and visceral/subcutaneous, hepatic and intramyocellular fat by MRI/MRS. Since we want to specifically determine the effects of exercise, there is no intent of weight loss. The subjects are weighed twice a week to assure weight stability.

Eligibility criteria: Inclusion Criteria:

* Healthy
* No medication
* Sedentary
* No first degree relative with diabetes,
* Hispanic
* BMI \>30 or \<25 kg/m2.

Exclusion Criteria:

* Any medication including birth control pills
* Performing more than \>45 min of moderate to light physical activity/week
* Chronic illness

Primary outcomes:
measure: Fat distribution, insulin sensitivity, glucose production, gluconeogenesis, glycogenolysis
timeFrame: In response to a 12 wk exercise program.
Secondary outcomes:
measure: Lipolysis, blood lipids, adiponectin, leptin and CRP
timeFrame: In response to a 12 wk exercise program
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Agneta L Sunehag, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06055855: Comparing Two-Needle vs. Surgery-Guided Arthrocentesis for TMJ Disorders
Official title: A Randomized Controlled Trial Evaluating the Efficacy of Conventional Two-Needle Arthrocentesis Versus Surgery-Guided Arthrocentesis in the Management of Temporomandibular Joint Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Disorders
Keywords: Arthrocentesis,Temporomandibular Joint
Guided surgery
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare two methods of arthrocentesis in treating temporomandibular joint (TMJ) disorders. The main questions it aims to answer are:

Is surgery-guided arthrocentesis more efficient in terms of operation time compared to traditional two-needle arthrocentesis? Does the use of surgical guides lead to less postoperative pain and better patient comfort?

Participants will:

Undergo either the traditional two-needle arthrocentesis or the surgery-guided arthrocentesis.

Be monitored for operation time, postoperative pain, and overall patient comfort.

Researchers will compare the outcomes of patients who underwent traditional two-needle arthrocentesis with those who had surgery-guided arthrocentesis to see if the latter can shorten operation time and improve patient comfort.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Wilkes stage II, III, or IV Temporomandibular Joint (TMJ) internal derangement.
* Presence of pain, sound, or both in the TMJ.
* Limitation or locking in mouth opening, or both.
* Patients who have not responded to symptoms after a minimum of three months of splint therapy.

Exclusion Criteria:

* Presence of infection in the puncture area.
* Presence of osteomyelitis in the neighboring region.
* Patients with uncontrolled coagulopathies.
* Patients experiencing limitation in maximum mouth opening without disk disorder.
* Patients with severe degenerative joint disease (e.g., deformed condylar contour, osteophyte findings in MRI).
* History of TMJ surgery.
* History of muscle-originated mandibular hypomobility.

Primary outcomes:
measure: Total Duration of Arthrocentesis Procedure
timeFrame: Immediately following the completion of each arthrocentesis procedure, anticipated to occur on the day of the surgery.
Secondary outcomes:
measure: Volume of Ringer's Solution Used for Joint Irrigation
timeFrame: Immediately following the completion of each arthrocentesis procedure, anticipated to occur on the day of the surgery.
measure: Change in Postoperative Pain
timeFrame: 7 days
measure: Change in Mouth Opening
timeFrame: 7 days
measure: Change in Facial Swelling
timeFrame: 7 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Dentistry
Study officials:
References: