louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00002104: Placebo-Controlled Trial of Safety and Efficacy of Thalidomide in Patients With Infections Due to Mycobacterium and/or HIV
Official title: Placebo-Controlled Trial of Safety and Efficacy of Thalidomide in Patients With Infections Due to Mycobacterium and/or HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mycobacterium Avium-Intracellulare Infection
HIV Infections
Tuberculosis, Mycobacterium Infection
Keywords: Mycobacterium tuberculosis
Mycobacterium Infections
AIDS-Related Opportunistic Infections
Mycobacterium avium-intracellulare Infection
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Mycobacterium Infections, Atypical
Thalidomide
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate, in patients with tubercular or nontubercular mycobacterium infections with or without HIV infection, the safety of thalidomide use as judged by symptoms, physical exam, and studies of microbiologic, immunologic, hematologic, renal, and hepatic status. To demonstrate efficacy of the drug as judged by status of fever, nutrition, tuberculosis lesions, and immune responses.

Detailed description: Patients are randomized to receive thalidomide or placebo orally at 9 PM the night before beginning anti-tuberculosis chemotherapy and continuing nightly for 7 nights. Patients are followed for 28 days. Patients are stratified according to HIV status and stage of HIV infection.

Eligibility criteria: Inclusion Criteria

Patients must have:

* Positive AFB smear and/or culture for Mycobacterium tuberculosis, M. avium, or other mycobacterial infection, with or without documented HIV infection. NOTE:
* HIV-positive patients must have CD4 count \< 500 cells/mm3 and be on antiretroviral therapy.
* One of the following manifestations:
* Temperature over 38 C on at least two occasions in the week prior to study entry.
* Recent weight loss of more than 5 kilograms.
* Pulmonary involvement of one or more lobes or involvement of other tissues due to tuberculosis or other mycobacterial infections, or symptomatic infections related to HIV status.
* Night sweats on two or more occasions in the week prior to study entry.

NOTE:

* Patients must be hospitalized men aged 18-65 and postmenopausal women to age 65. Anticipated requirement for hospitalization must be at least 10 days.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Neuropathy or other disorders with risk of neuropathy.

Required for HIV-positive patients if CD4 count \< 500 cells/mm3:

* Antiretroviral therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Bellevue Hosp Ctr
state: New York
city: New York
country: United States
facility: Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
state: New York
Study officials:
References:
Clinical trial NCT04161001: Clinical Trail to Evaluate the Efficacy and Safety of DWJ1451
Official title: A Multi-center, Randomized, Double-Blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWJ1451 in Patients With Hypertension and Dyslipidemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypertension, Dyslipidemia
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2019-11-13
Enrollment: 237
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * the change of sitSBP based on baseline between Treatment arm and control 1 arm \[ Time Frame: 8 weeks \]
* the change of LDL-C based on baseline between Treatment arm and control2 arm \[ Time Frame: 8 weeks \]


Eligibility criteria: Inclusion Criteria:

* Age 19 to 80 years
* patients with hypertension and hyperlipidemias

Exclusion Criteria:

* orthostatic hypotension
* History of ventricular tachycardia, atrial fibrillation
* uncontrolled diabetes mellitus

Primary outcomes:
measure: the change of MSSBP based on baseline between Treatment arm and control 1 arm
timeFrame: 8 weeks
measure: the change of LDL-C based on baseline between Treatment arm and control2 arm
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
References:
Clinical trial NCT00783601: MK0524 Asthma POC Study (0524-008)(COMPLETED)
Official title: A Multicenter, Randomized, Double Blind, Crossover Study Comparing the Effect of MK0524 With Placebo and Concomitant Administration of MK0524 Plus Montelukast in Adult Patients With Chronic Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Chronic Asthma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to demonstrate the benefit of MK0524 compared to placebo in patients with chronic asthma.


Eligibility criteria: Inclusion Criteria:

* Has symptoms of chronic asthma (shortness of breath, wheezing, chest tightness, etc.) for at least 1 year
* Nonsmoker for at least 1 year with a smoking history of no more than 7 pack-years (i.e., 1 pack per day for 7 years)

Exclusion Criteria:

* Any clinically significant disease of heart, intestinal, kidney, liver, lung or uncontrolled blood pressure
* Any surgery within 4 weeks prior to Visit 1
* Patient is intending to move or vacation for more than 5 days during the study
* Patient is pregnant or breast-feeding

Primary outcomes:
measure: To demonstrate benefits of MK0524 compared with placebo on Forced Expiratory Volume in 1 second (FEV1)
timeFrame: Last 2 weeks of each treatment period
Secondary outcomes:
measure: To determine the benefits of MK0524 as compared with placebo on the key secondary endpoints (Daytime & Nighttime Asthma Symptoms scores
timeFrame: Last 2 weeks of each treatment period
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Philip G, van Adelsberg J, Loeys T, Liu N, Wong P, Lai E, Dass SB, Reiss TF. Clinical studies of the DP1 antagonist laropiprant in asthma and allergic rhinitis. J Allergy Clin Immunol. 2009 Nov;124(5):942-8.e1-9. doi: 10.1016/j.jaci.2009.07.006. Epub 2009 Sep 12.
Clinical trial NCT00548301: Study of Cyclosporine in the Treatment of Dry Eye Syndrome (ST-603-007)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Lead sponsor: Sirion Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2007-10-23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this phase 3 study is to determine the safety and efficacy of cyclosporine in the treatment of dry eye syndrome.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of moderate to severe dry eye syndrome with or without Sjogren's syndrome or other autoimmune disease

Exclusion Criteria:

* Intraocular or refractive surgery in the study eye within 3 months prior to study start
* Unwilling to discontinue use of contact lenses during the run-in and duration of the study
* Pregnancy or lactation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bangor
country: United States
facility: Eye Center Northeast
state: Maine
Study officials:
affiliation: Sirion Therapeutics
name: Roger Vogel, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03253601: iADAPT to Support Strategy Training After Stroke
Official title: iADAPT to Support Strategy Training After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Adherence, Patient
Strategy Training
Keywords: Rehabilitation
Disability
Mobile Health Technology
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-08-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adherence to rehabilitation interventions is associated with functional outcomes (e.g. independence in daily activities, return of motor function) after stroke. Low adherence to rehabilitation home programs is common after stroke. Interventions delivered via mobile health applications demonstrated positive effects on adherence to health behaviors (e.g. medication routines, smoking cessation). The investigators developed the iADAPT mobile application to support adherence to Strategy Training. Strategy Training is an iterative rehabilitation intervention the promotes goal setting, planning, and self-monitoring after stroke. This study examines the effects of the iADAPT mobile health application relative to a workbook on adherence to Strategy Training after stroke.


Eligibility criteria: Inclusion Criteria:

-Diagnosis of Stroke

Exclusion Criteria:

* prior exposure to Strategy Training
* vision impairment that impairs ability to read device screen or worksheet
* poor self-awareness (score of ≥2 on Self Awareness of Deficits Inventory item #1 or #2
* current major depressive, bipolar, or psychotic disorder (Patient Health Questionnaire-9, PRIME-MD)
* current alcohol or drug abuse (Mini International Neuropsychiatric Interview)
* severe aphasia (score ≤1 on Boston Diagnostic Aphasia Examination)
* current diagnosis of dementia, neurodegenerative disease, or cancer
* anticipated discharge to a skilled nursing facility

Primary outcomes:
measure: Adherence: Observed client behavior
timeFrame: Baseline to 3 months
measure: Adherence: Client-reported progress on goals.
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Adherence: Client perspectives on treatment environment
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Elizabeth R. Skidmore, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04055701: Fetal Thymus Volume of Dichorionic Diamniotic Twin
Official title: Relationships Between Preterm Labor and Fetal Thymus Volume in Twin Pregnancies at Second-trimester
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Twin Pregnancy, Antepartum Condition or Complication
Fetal Thymus Volume
Preterm Birth
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: In some studies of fetal thymus volume, fetal stress factors; infection, preterm premature premature rupture of membranes, preeclampsia, preterm delivery risk.

Generally, there is a direct correlation between fetal growth and thymus volume and it was observed that thymus volume decreased in pregnancies accompanied by fetal stress factors.The aim of this study was to measure fetal thymus volume in second trimester twin pregnancies and to investigate whether there is a statistically significant correlation between preterm birth risk pregnancies.


Eligibility criteria: Inclusion Criteria:

* Dichorionic di amniotic twin pregnancies between 18 weeks and 23 days 6 days

Exclusion Criteria:

* Single pregnancy,
* first and third trimester pregnant women,
* urinary tract infection, immune system diseases
* fetuses with intrauterine genetic and / or multiple morphological diseases

Primary outcomes:
measure: fetal thymus volume
timeFrame: first 6 months
measure: fetal thymus volume
timeFrame: last6 months
measure: fetal thymus volume
timeFrame: last 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University
Study officials:
References:
citation: Borgelt JM, Mollers M, Falkenberg MK, Amler S, Klockenbusch W, Schmitz R. Assessment of first-trimester thymus size and correlation with maternal diseases and fetal outcome. Acta Obstet Gynecol Scand. 2016 Feb;95(2):210-6. doi: 10.1111/aogs.12790. Epub 2015 Nov 17.
Clinical trial NCT00323401: The Influence of Antenatal Classes on Pregnancy, Birth and Parenthood
Official title: The Influence of Antenatal Classes on Pregnancy, Birth and Parenthood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Parturition
Keywords: Pregnancy
Parturition
Depression
Randomized
Antenatal classes
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital Skejby
First posted: 2006-05-09
Enrollment: 1192
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 1. To study the influence of antenatal classes for first time parents and their effect ob pregnancy, birth and parenthood.
2. Randomized into two groups (a. 3 courses in midpregnancy and b. no courses)
3. Data on pregnancy, birth and parenthood are collected from register and questionaire

Detailed description: Data collected contain register data and data from questionnaire, which also contains psychometric tests

Eligibility criteria: Inclusion Criteria:

Pregnant Over 18 years of age Singleton

Exclusion Criteria:

Primary outcomes:
measure: Arrival for birth
timeFrame: prospective
measure: Birth experience
timeFrame: prospective
measure: Medical interventions during delivery
timeFrame: prospective
measure: Use of birth analgesia
timeFrame: prospective
Secondary outcomes:
measure: Length of Birth
timeFrame: prospective
measure: Post partum depression
timeFrame: prospective
measure: Breastfeeding duration and experience
timeFrame: prospective
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: University of Aarhus and University Hospital, Skejby
city: Aarhus
country: Denmark
facility: Skejby Sygehus
Study officials:
affiliation: University of Aarhus, Department of Epidemiology
name: Jørn Olsen, Professor
role: STUDY_CHAIR
References:
citation: Maimburg RD, Vaeth M, Hvidman L, Durr J, Olsen J. Women's worries in first pregnancy: results from a randomised controlled trial. Sex Reprod Healthc. 2013 Dec;4(4):129-31. doi: 10.1016/j.srhc.2013.10.001. Epub 2013 Oct 9.
Clinical trial NCT05069701: The Effect of Different Head and Trunk Positions on SVV in Healthy Individuals
Official title: The Effect of Different Head and Trunk Positions on Static Virtual SVV and Dynamic Virtual SVV in Healthy Individuals: A Standardization Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Aim: To obtain standardization data in static virtual SVV and dynamic virtual SVV tests according to different head and body positions by keeping up with developing technologies. In this way, it is planned to evaluate the treatment responses of patients who receive vestibular rehabilitation in a healthier way.


Eligibility criteria: Inclusion Criteria:

1. Healthy adult volunteers
2. Volunteers over 18 years old

Exclusion Criteria:

1. Patients with impaired cooperation
2. Musculoskeletal or systemic presence of disease
3. Past ear disease
4. Patients who have experienced dizziness
5. Presence of central nervous system pathology
6. Patients who have used ototoxic drugs
7. Patients whose use of glasses may cause problems (epilepsy, vision loss, etc.)

Primary outcomes:
measure: Static SVV test
timeFrame: 1 month
measure: Dynamic SVV test
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Fazıl Necdet Ardıç, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03764501: Image Fusion System for 3D Preoperative Planning in the Osteosynthesis and Osteotomy
Official title: Image Fusion System for 3D Preoperative Planning in the Osteosynthesis and Osteotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fractures, Bone
Fracture Malunion, Bone
Lead sponsor: Tokyo Medical University
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Image fusion group will utilize 3D preoperative planning and image fusion system. Control group will utilize only 3D preoperative planning.
Primary purpose: TREATMENT

Brief summary: Utility of image fusion system for the fracture and fracture malunion management will be evaluated.

Detailed description: The fracture and malunion patients need osteosynthesis or osteotomy will be recruited. Image fusion group utilizes 3D preoperative planning and image fusion system. Control group utilizes only 3D preoperative planning. The age, sex, and fracture types will be matched between groups. In both groups, 3D preoperative planning will be performed in order to determine reduction, placement and choices of implants. In the image fusion group, the outline of planned image will be displayed on the monitor overlapping with fluoroscopy image during surgery. Reductions, implant choices/positions, and clinical outcomes will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Fracture paitents need osteosynthesis

Exclusion Criteria:

* Fracture patients under 18 years old

Primary outcomes:
measure: Reduction accuracy
timeFrame: 1month after the surgery
measure: Implant placement
timeFrame: 1month after the surgery
measure: Implant choices
timeFrame: 1month after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ami
country: Japan
facility: Tokyo Medical University Ibaraki Medical Center
state: Ibaraki
Study officials:
References:
citation: Yoshii Y, Ogawa T, Hara Y, Totoki Y, Ishii T. An image fusion system for corrective osteotomy of distal radius malunion. Biomed Eng Online. 2021 Jun 30;20(1):66. doi: 10.1186/s12938-021-00901-8.
citation: Yoshii Y, Totoki Y, Sashida S, Sakai S, Ishii T. Utility of an image fusion system for 3D preoperative planning and fluoroscopy in the osteosynthesis of distal radius fractures. J Orthop Surg Res. 2019 Nov 6;14(1):342. doi: 10.1186/s13018-019-1370-z.
Clinical trial NCT02254980: Migration and Head Penetration of Vitamin-E Diffused Cemented Polyethylene Cup in Total Hip Arthroplasty
Official title: Migration and Head Penetration of Vitamin-E Diffused Cemented Polyethylene Cup Compared to Standard Cemented Cup in Total Hip Arthroplasty. A Randomized, Single-blinded, Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Total Hip Arthroplasty
Keywords: Total hip arthroplasty
Cemented acetabular cup
Vitamin-E
Radiostereometry
Fixation of cemented acetabular component in total hip arthroplasty
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2014-10-02
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In vitro, Vitamin-E diffused, highly cross-linked polyethylene (PE) have been shown to have superior wear resistance and improved mechanical properties as compared to that of standard highly cross-linked PE. There are as of yet no published studies with vitamin-E diffused PE although several trials are ongoing. All of these trials use uncemented acetabular cups intended for biological fixation. In many countries the standard fixation method for the acetabular component is bone-cement. The Vitamin-E used in implants is alfa-tocopherol, a lipid-soluble antioxidant with oily consistency; theoretically affecting cemented fixation when used in acetabular components. The aim of the study is to compare migration, linear wear and clinical results between two types of cemented acetabular cups.


Eligibility criteria: Inclusion Criteria:

* Primary osteoarthritis of the hip
* Willingness and ability to follow study-protocol

Exclusion Criteria:

* Inflammatory arthritis or secondary osteoarthritis.
* Type C (stove pipe) femur
* Abnormal femoral or pelvic anatomy after hip dysplasia, not suitable for implantation of components
* Treatment with bisphosphonates, cortisol or cytostatic drugs 6 months prior to surgery
* Ongoing oestrogen treatment
* Not suited for the study for other reason (surgeons preference)

Primary outcomes:
measure: Cup migration
timeFrame: 2 years
Secondary outcomes:
measure: Linear wear
timeFrame: 2 years
measure: Linear wear
timeFrame: 4 years
measure: Osteolysis
timeFrame: 10 years
measure: Osteolysis
timeFrame: 2 years
measure: Functional outcome
timeFrame: 2 years
measure: Complication rate
timeFrame: 10 years
measure: Cup migration total
timeFrame: 2 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Orthopaedic department, Danderyd Hospital
Study officials:
References:
citation: Skoldenberg O, Rysinska A, Chammout G, Salemyr M, Muren O, Boden H, Eisler T. Migration and head penetration of Vitamin-E diffused cemented polyethylene cup compared to standard cemented cup in total hip arthroplasty: study protocol for a randomised, double-blind, controlled trial (E1 HIP). BMJ Open. 2016 Jul 7;6(7):e010781. doi: 10.1136/bmjopen-2015-010781.