louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01778244: Metformin for Treatment of Antipsychotic-induced Dyslipidemia
Official title: Metformin for Treatment of Antipsychotic-induced Dyslipidemia: a Randomized, Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyslipidemia
Keywords: schizophrenia; dyslipidemia
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2013-01-29
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Almost all antipsychotics can induce dyslipidemia, but no treatment has been established. Metformin can improve lipid levels in obese patients. The investigators conducted a randomized, placebo-controlled study to test the efficacy of metformin for antipsychotic-induced dyslipidemia.

Detailed description: The study was designed as a double-blind randomized controlled trial, with research assessors and patients intended to be blind to the intervention status. The staff members performing the assessment were not involved in implementing any aspect of the intervention.162 patients were randomized to one of two 24-week individual treatments: metformin (1000mg/day)or placebo. Medications were provided in double-blind fashion.The assessments include lipid levels, body weight, body mass index, fasting glucose, fasting insulin and insulin resistance index.

Eligibility criteria: Inclusion Criteria:

Diagnostic and Statistical Manual of Mental Disorder-Fourth Edition (DSM-Ⅳ) criteria for schizophrenia dyslipidemia after antipsycotic treatment the duration of illness was less than 12 months taking only one antipsychotic stable outpatient the total score of Positive and Negative Syndrome Scale (PANSS)≤60.

-

Exclusion Criteria:

liver or renal diseases pregnant or lactating women cardiovascular diseases hypertension or diabetes mellitus

Primary outcomes:
measure: low-density lipoprotein cholesterol
timeFrame: 8 weeks
Secondary outcomes:
measure: high-density lipoprotein cholesterol
timeFrame: 8 weeks
measure: adverse effects
timeFrame: 8 weeks
Other outcomes:
measure: body mass index
timeFrame: 8 weeks
Locations:
city: Changsha
country: China
facility: Institute of Mental Health of The Second Xiangya Hospital, Central South University
state: Hunan
Study officials:
affiliation: Central South University
name: Renrong Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00184444: Effect of Increased Oxygenation in the Air During Endurance Training in Stable Angina Pectoris Patients
Official title: Effect of Increased Oxygenation in the Air During Endurance Training in Stable Angina Pectoris Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Angina Pectoris
Keywords: angina pectoris
hyperoxia
endurance training
stroke volume
cardiac perfusion
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2005-09-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study investigates whether endurance training breathing 100% oxygen gives a additional improvement of maximal oxygen uptake in stable Angina Pectoris patients, compared to training without extra oxygen supplementation. In addition work economy, stroke volume and cardiac perfusion is measured.

The hypothesis of the study is that increased oxygenation of the air increases performance, stroke volume, work economy and cardiac perfusion.


Eligibility criteria: Inclusion Criteria:

* stable angina pectoris age 18-75

Exclusion Criteria:

* unstable angina pectoris
* Limitations to exercise other than coronary artery disease
* Participants in other study interventions

Primary outcomes:
measure: maximal oxygen uptake
timeFrame: Baseline and post training
Secondary outcomes:
measure: Cardiac perfusion
timeFrame: Baseline and post training
measure: work economy
timeFrame: Baseline and post training
measure: cardiac output
timeFrame: baseline and post training
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: Norwegian university of sience and technology
name: Asbjørn Støylen, MD
role: STUDY_DIRECTOR
References:
citation: Karlsen T, Hoff J, Stoylen A, Skovholdt MC, Gulbrandsen Aarhus K, Helgerud J. Aerobic interval training improves VO2 peak in coronary artery disease patients; no additional effect from hyperoxia. Scand Cardiovasc J. 2008 Oct;42(5):303-9. doi: 10.1080/14017430802032723.
Clinical trial NCT01173744: Comparison of Gamma Nail Versus Dynamic Hip Screw for the Treatment of Unstable Intertrochanteric Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intertrochanteric Femoral Fractures
Keywords: Intertrochanteric femoral fractures - unstable
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-08-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to examine the treatment of unstable Intertrochanteric fractures with the short Gamma nail, compared to the use of the dynamic hip screw (DHS).

This is a prospective study. Sixty patients with unstable Intertrochanteric fractures will be randomized to be treated using either Gamma nail or DHS. The patients will be followed for 12 months. The primary endpoint is the clinical outcome as measured by the Merle d'Aubigne and Postelhip score.


Eligibility criteria: Inclusion Criteria:

* Acute Intertrochanteric fracture - A1-32 AO/OTA
* Abbreviated mental score \>6
* Community ambulator (pre-fracture state)

Exclusion Criteria:

* Previous arthritis
* Pathological fracture
* Chronic corticosteroid use
* Concomitant lower extremity fractures

Primary outcomes:
measure: Clinical outcome as measured by the Merle d'Aubigne and Postel hip score
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: E. WOlfson medical center
Study officials:
References:
Clinical trial NCT01211392: Detection of Bone Marrow Changes: Comparison of MRI and DECT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Marrow Changes
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2010-09-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with bone marrow changes

Brief summary: Prospective study where magnetic resonance imaging is compared to dual-energy computed tomography for the detection of bone marrow changes.


Eligibility criteria: Inclusion criteria:

* Patients with bone marrow changes

Exclusion criteria:

* Pregnacy
* Age below 18 ys old
* Contraindications for MRI

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT03949192: Efficacy of Kangliuwan for Recurrent Grade IV Glioma
Official title: Efficacy of Hospital Traditional Chinese Medicine Preparation Kangliuwan for Recurrent Grade IV Glioma: A Prospective Exploratory Clinical Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioma of Brain
Recurrence
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Recurrent grade IV glioma patients and conventional treatment is invalid.

Brief summary: A Prospective Exploratory Clinical Study to explore the efficacy of Hospital Traditional Chinese Medicine Preparation Kangliuwan for Recurrent Grade IV Glioma.


Eligibility criteria: Inclusion Criteria:

1. The patient signed "informed consent" voluntarily;
2. The age of patient is between 18 and 80 years;
3. KPS score ≥40 ; The patient has normal liver and kidney function Normal heart function Better follow-up and compliance;

Exclusion Criteria:

1. The patient did not sign "informed consent" or signed unvoluntarily.
2. Non-glioma patients
3. Active infection
4. Human immunodeficiency virus (HIV) positive
5. Hepatitis C or hepatitis B infective
6. Pregnancy or breast-feeding women
7. Patients did not agree to use effective contraception during treatment and the following 3 months.
8. Patients also participated in other clinical studies.
9. The subjects researchers believe are not suitable for participation or completion of the study.

Primary outcomes:
measure: Changes in tumor volume
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Qingtang Lin, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Xuanwu Hospital, Beijing
name: Xiaolan Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The General Hospital of People's Liberation Army (301 hospital)
name: Ling Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05897892: The Clinical Study on the Mangrove Sword Bean Food Bar Effect for Older People
Official title: School of Environmental Sciences - University of Indonesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition Disorders in Old Age
Disaster
Keywords: Older people
disaster
weight
mangrove-sword bean food bar
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 31
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment group consumed mangrove sword bean food bar during 15 days. Control group consumed sword bean food bar during 15 days. Balanced nutrition education undertaken to all subjects at two groups once at the first week of study.
Primary purpose: PREVENTION

Brief summary: The goal of this clinical study is to assess the api-api mangrove sword bean food bar effect on the older people's weight affected by a landslide

The main questions aimed to answer are:

* Can api-api mangrove sword bean food bar improve the weight of older people affected by landslide?
* Can balanced nutrition education increase the older peoples' knowledge?

Participants divided in the two groups i.e.:

* Treatment group received 50 g mangrove sword bean food bar each day during 15 days.
* Control group received 50 g sword bean food bar each day during 15 days.
* Both groups obtained balanced nutrition of older people education once at the first week of study.

Detailed description: Treatment group received 50 g mangrove sword bean food bar each day during 15 days.

Control group received 50 g sword bean food bar each day during 15 days. Both groups obtained balanced nutrition of older people education once at the first week of study.

Compliance monitoring to control the food compliance by the subjects at two groups through home visit, weight measurement, three days food recall, and food bar distribution checking by trained enumerators.

Eligibility criteria: Inclusion Criteria:

* Aged 60 years old or above
* Male and female
* Living in Cihanjuang Village, Sumedang District, West Java Province Indonesia who affected by the landslide disaster
* Had normal, under-, or over-nutrition status
* Not suffering from chronic diseases or degenerative diseases during the study.
* Willing to avoid consumption of any snacks other than the food bars and plain water.

Exclusion Criteria:

* Having difficulty mobilities to run daily basic activities.
* Suffered from infectious and or a chronical diseases.

Primary outcomes:
measure: Mangrove sword bean food bar on the weight of older people
timeFrame: Two weeks
Secondary outcomes:
measure: Balanced nutrition knowledge of older people
timeFrame: Two weeks
Other outcomes:
Locations:
city: Sumedang
country: Indonesia
facility: Health integrated post for older people office
state: West Java
Study officials:
affiliation: Indonesia University
name: Fatmah Fatmah, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04638192: Transcranial Alternating Current Stimulation for Hand Function Recovery
Official title: Design of Synchronized Pairing Peripheral Nerve Stimulation and Cortical Polarization to Promote Post-stroke Neuroplasticity for Hand Function Recovery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: tACS has the potential to directly induce cortical alterations in the intrinsic neural oscillation at specific frequencies, and the brain could mirror the induced frequencies of the external source of oscillations from the stimulation. Hence, tACS with matching stimulation frequency could be an effective means of enhancing brain oscillatory activity to potentially induce synaptic plasticity for restoration of damaged brain functions. However from the existing studies of applying tACS over the M1 in healthy and diseased brains, there is a wide range of applied stimulation frequencies and varied neuromodulation effects on motor behavior or cortical excitability at different frequencies. In this proposal, subject-specific stimulation frequency and latency will be identified.


Eligibility criteria: Inclusion Criteria:

* Hemiparesis subsequent to first-ever unilateral stroke for more than 6 months;
* MCP and PIP finger joints can be extended to 180° passively;
* Sufficient cognition to follow the experimental instructions

Exclusion Criteria:

* Severe hand spasticity or hand deformity;
* History of alcohol or drug abuse or epilepsy;
* Bilateral brain infarcts;
* Severe cognitive deficits;
* Comprehensive aphasia;
* Contraindications to tACS and MRI

Primary outcomes:
measure: Magnetic resonance imaging
timeFrame: 3-month after the 10th session training
Secondary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: 3-month after the 10th session training
measure: Fugl-Meyer Assessment (Upper Extremity)
timeFrame: 3-month after the 10th session training
measure: Wolf Motor Function Test (WMFT)
timeFrame: 3-month after the 10th session training
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Department of Biomedical Engineering, The Chinese University of Hong Kong
Study officials:
affiliation: Department of Biomedical Engineering, The Chinese University of Hong Kong
name: Raymond Tong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01757392: Candin Safety & Efficacy Study for the Treatment of Warts
Official title: Study of the Safety and Effectiveness of Candin for the Treatment of Common Warts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Warts
Human Papilloma Virus
Keywords: Treatment
common wart lesions
(verruca vulgaris)
Lead sponsor: Nielsen BioSciences, Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-28
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at a 0.3 ml dose level at up to 6 monthly injections for treating common warts (Verruca vulgaris).

Detailed description: The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at either 0.3 mL dose levels at up to 6 monthly injections (a maximal, cumulative dose of 1.9 mL, including the delayed-type hypersensitivity (DTH) test) for treating common warts (Verruca vulgaris). A secondary objective is to understand the relative effectiveness of the 0.3 dose level for treating common warts, both those that were injected and those that were not injected as well as other types of warts that were not injected to allow a determination of appropriate dose levels to use in a future dose-ranging efficacy trial.

Eligibility criteria: Inclusion Criteria:

* Must have at least 3 and not more than 10 common warts not located on the palms or digits
* Positive DTH response to Candin® required

Exclusion Criteria:

* No previous medical treatment for warts other than OTC
* No immunocompromising medical conditions or medicines allowed
* No preexisting inflammatory conditions at treatment site allowed

Primary outcomes:
measure: Number of Participants With Complete Resolution of Primary Injected Wart
timeFrame: Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months
Secondary outcomes:
measure: Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits
timeFrame: Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Johnson Dermatology
state: Arkansas
Study officials:
affiliation: Johnson Dermatology
name: Sandy M Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04909892: Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise
Official title: A Phase 2a Study of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Covid19
Keywords: covid-19
long haul
post-acute covid
Lead sponsor: Sorrento Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-02
Enrollment: 0
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 a Phase 1b study to assess the safety and efficacy of COVI-MSC in treating post COVID-19 "long haulers" with pulmonary compromise.

Detailed description: This is a Phase 1b multicenter study to assess the safety and efficacy of COVI-MSC in treating post COVID-19 "long haulers" with pulmonary compromise.

COVI-MSC will be administered intravenously on Day 0, Day 2, and Day 4.

Eligibility criteria: Inclusion Criteria:

* Has had prior laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen
* Has had a recent (within a week) negative SARS-CoV-2 test (an approved PCR or antigen test)
* Has had at least moderate or severe post-COVID-19 pulmonary symptoms for at least 3 months which have resulted in reduced physical functioning compared to pre-COVID-19 status
* Willing to follow contraception guidelines

Exclusion Criteria:

* Clinically improving pulmonary status over the month prior to screening
* Undergone a previous stem cell infusion unrelated to this trial
* Pregnant or breast feeding or planning for either during the study
* Suspected uncontrolled active bacterial, fungal, viral, or other infection
* History of a splenectomy, lung transplant or lung lobectomy
* Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)

Primary outcomes:
measure: Change in 6-Minute Walk Distance (6MWD) at Day 60
timeFrame: Baseline to Day 60
Secondary outcomes:
measure: Change in 6MWD at Day 30
timeFrame: Baseline to Day 30
measure: Change in Pulmonary Function Tests (PFTs)
timeFrame: Baseline to Day 30 and Day 60
measure: Change in oxygenation
timeFrame: Baseline to Day 30 and Day 60
measure: Change in biomarker levels
timeFrame: Baseline through Day 30
Other outcomes:
Locations:
Study officials:
affiliation: Sorrento Therapeutics, Inc.
name: Mike Royal, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06885892: Posterior Tibial Artery Perforator-Pedicled Propeller Flaps in Reconstruction
Official title: Posterior Tibial Artery Perforator-Pedicled Propeller Flaps for Reconstruction of the Defects in the Lower Leg（Case Series）
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma Patients with Soft Tissue Defects
Keywords: the lower leg
soft tissue defects
perforator flaps
propeller flaps
doppler ultrasound
Lead sponsor: The Affiliated Hospital of Xuzhou Medical University
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 14
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Soft tissue defects in the lower leg remain a challenge for surgeons due to frequent bone exposure and paucity of soft tissues. The goal in this study was to evaluate the surgical technique and clinical significance of posterior tibial artery perforator-pedicled propeller flaps for reconstruction of defects in the lower leg.

Detailed description: The construction of the lower extremity defects with exposed bone and tendon is considered as the biggest challenge of all body regions in many plastic and reconstructive surgeons. The lower leg regions are in visible areas. Defects recovery and aesthetic consideration should be considered at the same time with the development of the economy and society. Although free flaps have been used to reconstruct these defects, some disadvantages still exist, such as needing microinstruments, long operation time and none like-with-like repair. In this article, a series of patients with soft tissue defects in the lower leg were transplanted with posterior tibial artery perforator-pedicled propeller flaps.

Eligibility criteria: Inclusion Criteria:

* 1.age range :10-80years. 2. in good overall heath without severe comorbidities. 3. posterior perforator tibial artery is no damage.

Exclusion Criteria:

1. age range \<10years or \>80years.
2. with severe comorbidities
3. Posterior perforator tibial artery of panticipants is damage

Primary outcomes:
measure: flaps observation
timeFrame: 12-24months
Secondary outcomes:
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
Study officials:
References:
citation: Lin J, Zhou F, Sun YD, Gao YS, Li HZ, Zheng HP, Zhang YF, Li QF, Ward PJ, Yang YL, Liu CY. Modified Anterior Tibial Artery Perforator-Pedicled Propeller Flap for Soft-Tissue Coverage of the Ankle and Heel. World J Surg. 2020 Jul;44(7):2237-2242. doi: 10.1007/s00268-020-05452-y.
citation: Jakubietz RG, Jakubietz MG, Gruenert JG, Kloss DF. The 180-degree perforator-based propeller flap for soft tissue coverage of the distal, lower extremity: a new method to achieve reliable coverage of the distal lower extremity with a local, fasciocutaneous perforator flap. Ann Plast Surg. 2007 Dec;59(6):667-71. doi: 10.1097/SAP.0b013e31803c9b66.