louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00431145: Niacin As Secondary Prevention Of Coronary Artery Disease (NASPOCAD)
Official title: Influence of Combined Therapy of Niacin and Statins on Stem Cell Mobilization and Inflammatory Parameters in Patients Suffering From Coronary Artery Disease - Randomized Clinical Study -
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Coronary Artery Disease
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2007-02-05
Enrollment: 80
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: Aim of the study is to show additional effects of the combined therapy of niacin and statins analyzing number and function of EPCs and other stem cell populations and adiponectin as well as hsCRP levels in patients with CAD.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years old, male or female
* Have stable coronary artery disease (i.e. no acute event like myocardial infarction or PTCA less then 3 months ago)
* LDL \> 100 mg/dl
* HDL \< 50 mg/dl
* Triglycerides \< 400 mg/dl
* No Nicotine abuse for at least 3 months
* Statin-therapy for more than 4 weeks
* Give a written informed consent
* Have the ability to understand the requirements of the study, and agree and be able to return for the required assessments.

Exclusion Criteria:

* Women of childbearing potential, pregnancy or being lactating
* Current participation in another clinical trial
* Have other severe concurrent illness (e.g., active infection, malignancy)
* Have a history of alcohol or drug abuse within 3 months of admission or factors making follow-up difficult or unlikely.
* Have significant or unexplained liver dysfunction or chronic increased levels of transaminases (ALT, AST)
* Suffer from myopathy, active peptic disease or arterial bleeding
* Have a known hypersensitivity against niacin or statins
* Are actually treated with any of itraconazole, ketoconazole, HIV-Protease-Inhibitors, erythromycin, clarithromycin, telithromycin, nefazodone.
* Actual therapy with ezetimibe
* Diabetes mellitus Type I

Primary outcomes:
measure: numbers of EPCs and inflammatory markers
measure: adiponectin
measure: hsCRP
measure: each after 8 weeks
Secondary outcomes:
measure: numbers of EPCs,
measure: inflammatory markers
measure: adiponectin
measure: hsCRP
measure: each after 4 weeks
measure: number and type of progenitor cells
measure: dendritic cells
measure: cytokines
measure: lipoproteins in peripheral blood
measure: vascular function
measure: each after 4 and 8 weeks
measure: carotid artery distensibility
measure: carotid artery plaque composition
measure: each after 8 weeks
measure: optionally 1 year follow-up
Other outcomes:
Locations:
city: Munich
country: Germany
facility: University of Munich
Study officials:
affiliation: University of Munich/Germany
name: Wolfgang M Franz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01750645: Management of the Idiopathic Overactive Bladder With Botulinum Toxin: Systematic Review
Official title: Management of the Idiopathic Overactive Bladder With Intradetrusor Injection of Type-A Botulinum Toxin: Systematic Review of the Literature
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Bladder, Overactive
Lead sponsor: Clínica Infantil Colsubsidio
Sponsor class: OTHER
First posted: 2012-12-17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with idiopathic overactive bladder

Brief summary: Overactive bladder is defined as a syndrome composed of urgency, increased urinary frequency, and sometimes urinary incontinence; its etiology may be characterized as neurogenic or non-neurogenic (i.e., idiopathic). This illness has a great impact in quality of life and one of the available treatments is the injection of Botulinum Toxin. This study aims to review the efficacy and safety of type-A Botulinum Toxin in the management of Idiopathic Overactive Bladder. A systematic search was performed in MEDLINE, EMBASE, CENTRAL and LILACS, and the controlled randomized clinical trials were chosen to review with the CONSORT criteria by independent reviewers. Outcomes analyzed were the efficacy of the intervention for relieving the symptoms (urgency, frequency and urgency incontinence), adverse events to treatment, change in quality of life and urodynamic measures.


Eligibility criteria: Inclusion Criteria:

* Controlled randomized clinical trials
* Adult patients diagnosed with idiopathic overactive bladder
* Language of the study: english

Exclusion Criteria:

* Diagnosis of neurogenic overactive bladder
* Patients under 18 years old
* Use of Type-B Botulinum Toxin as the intervention
* Other types of studies

Primary outcomes:
measure: Efficacy of the intervention for relieving the symptoms (urgency, frequency and urgency incontinence)
timeFrame: Minimun follow-up period of 12 weeks
Secondary outcomes:
measure: Adverse events to treatment (urinary retention and urinary tract infections)
timeFrame: Minimun follow-up period of 12 weeks
measure: Change in quality of life
timeFrame: Minimun follow-up period of 12 weeks
measure: Change in urodynamic measures
timeFrame: Minimun follow-up period of 12 weeks
Other outcomes:
Locations:
city: Bogotá DC
country: Colombia
facility: Clínica Infantil Colsubsidio
Study officials:
affiliation: Clínica Infantil Colsubsidio
name: Hugo E López, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01172145: Treatment of Apathy in Alzheimer's Disease With Modafinil
Official title: Treatment of Apathy in Alzheimer's Disease With Modafinil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Apathy
Alzheimer's Disease
Keywords: apathy
Alzheimer's disease
activities of daily living performance
caregiver burden
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Cephalon
First posted: 2010-07-29
Enrollment: 22
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examined the effects of modafinil on apathetic symptomatology, performance of activities of daily living (ADLs) and caregiver burden in individuals with Alzheimer's disease (AD).


Eligibility criteria: Inclusion Criteria:

* diagnosis of mild to moderate stage Probable Alzheimer's disease
* on a stable dose of a cholinesterase inhibitor medication for at least 30 days
* clinically elevated levels of apathy as measured by the Frontal Systems Behavior Scale

Exclusion Criteria:

* diagnosis of Major Depression
* focal brain lesion on neuroimaging
* history of significant substance abuse
* history of significant head trauma with loss if consciousness \>10 minutes

Primary outcomes:
measure: Apathy
timeFrame: at baseline
measure: Apathy
timeFrame: after 8 weeks of treatment
Secondary outcomes:
measure: Lawton Brody Activities of Daily Living Questionnaire
timeFrame: at baseline
measure: The Direct Assessment of Functional Status Scale
timeFrame: at baseline
measure: Zarit Burden Inventory
timeFrame: at baseline
measure: Lawton Brody Activities of Daily Living Questionnaire
timeFrame: after 8 weeks of treatment
measure: The Direct Assessment of Functional Status Scale
timeFrame: after 8 weeks of treatment
measure: Zarit Burden Inventory
timeFrame: after 8 weeks of treatment
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Memorial Hospital of Rhode Island
name: Laura L Frakey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frakey LL, Salloway S, Buelow M, Malloy P. A randomized, double-blind, placebo-controlled trial of modafinil for the treatment of apathy in individuals with mild-to-moderate Alzheimer's disease. J Clin Psychiatry. 2012 Jun;73(6):796-801. doi: 10.4088/JCP.10m06708. Epub 2012 May 15.
Clinical trial NCT05463445: Multicenter Observational Study of PSC and IgG4-SC in China
Official title: Multicenter Study of Clinical Characteristics and Management of Primary Sclerosing Cholangitis and IgG4-related Sclerosing Cholangitis in China.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Sclerosing Cholangitis
IgG4-related Sclerosing Cholangitis
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This program will be conducted in multiple medical centers among the major cities across Mainland China. The sample size of subjects will be 1000, including 500 patients with PSC and 500 patients with IgG4-SC.

Brief summary: The investigators aimed to collect demographic features and clinical outcomes in patients diagnosed with PSC and IgG4-SC by utilizing participants database from multiple medical centers across Mainland China. Cross-sectional studies will focus on characterizing clinical presentations and validating diagnostic and prognostic models on Chinese PSC and IgG4-SC patients.


Eligibility criteria: Inclusion Criteria:

* Age above 18 years old,
* Male or Female,
* Patients admitted in our medical centers which met the PSC criteria according to The European Association for the Study of the Liver Clinical Practice Guidelines "Management of cholestatic liver diseases" in 2009; or patients diagnosed with IgG4-SC which met initially using the Japan Pancreas Society criteria and confirmed using HISORt criteria.

Exclusion Criteria:

* Female subjects who is pregnant, breastfeeding or is considering being pregnant during the study;
* History of other malignancies, including hematological tumors, solid tumors except hepatobiliary system;
* History of infectious diseases, including hepatis A, B, C, E and tuberculosis.

Primary outcomes:
measure: The percentage of new occurrence of decompensated liver related events, malignancies, liver transplantation and liver-related death caused by PSC and IgG4-SC
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: RenJi Hospital
state: 上海市
Study officials:
References:
Clinical trial NCT00683345: Fatigue and Interleukin-1 (IL-1) Blockade in Primary Sjøgrens Syndrome
Official title: Fatigue and IL-1 Blockade in Primary Sjøgrens Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fatigue
Primary Sjogren
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: University of Oslo
name: University of Stavanger
First posted: 2008-05-23
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fatigue is a prevalent phenomenon in Primary Sjøgrens syndrome (PSS). Observations indicate that the cytokine IL-1 is of importance for this phenomenon. In this study the investigators block IL-1 by giving Anakinra (an IL-1 receptor antagonist) to patients with PSS.

Detailed description: A double-blind, placebo-controlled, parallel study of the effect on fatigue of daily injections of Anakinra for one month.

Eligibility criteria: Inclusion Criteria:

* Primary Sjøgrens Syndrome according to the European-American criteria
* Age 18-80 years
* Written informed consent

Exclusion Criteria:

* Hyper- og hypothyreosis
* Malignant disease
* Parkinsons disease
* Multiple sclerosis
* Conditions or diseases where Anakinra is contraindicated
* Mental depression (BDI \>13)
* Neutropenia (\<1.5\*10.9)
* Frequent infections
* Pregnancy, lactating women.

Primary outcomes:
measure: Fatigue as measured by Fatigue Severity Scale and a visual analogue fatigue scale
timeFrame: 4 weeks
Secondary outcomes:
measure: Inflammatory cytokines and measures of oxidative stress
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
Study officials:
affiliation: Helse Stavanger HF
name: Roald Omdal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Norheim KB, Harboe E, Goransson LG, Omdal R. Interleukin-1 inhibition and fatigue in primary Sjogren's syndrome--a double blind, randomised clinical trial. PLoS One. 2012;7(1):e30123. doi: 10.1371/journal.pone.0030123. Epub 2012 Jan 10.
Clinical trial NCT00139945: Ghrelin, Growth Hormone and Cortisol Interaction in Growth Hormone Deficient Patients
Official title: Effects of Acute Ghrelin Infusion to Growth Hormone Deficient Adults: Growth Hormone and Cortisol Interaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypopituitarism
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2005-08-31
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In growth hormone deficient patients: Determination of endogenous circulating ghrelin levels, ghrelin effects on insulin sensitivity, appetite, energy metabolism, and signal transduction in fat and muscle.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 60 yrs.
* Verified hypopituitarism
* Unchanged substitution treatment through 3+ months
* Unchanged additional medical treatment
* Oral and written informed consent

Exclusion Criteria:

* Age below 18 or above 60 yrs.
* Diabetes mellitus
* body mass index \> 30
* Fasting hypoglycemia
* Convulsions
* Allergy to trial products

Primary outcomes:
measure: Endogenous serum ghrelin levels
timeFrame: Same day as intervention
Secondary outcomes:
measure: Insulin sensitivity, appetite, metabolism, intracellular signal transduction
timeFrame: Same day as intervention
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Jens Otto L Jorgensen, DrMedSci
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lauritzen ES, Jorgensen JOL, Moller N, Nielsen S, Vestergaard ET. Increased lipolysis after infusion of acylated ghrelin: a randomized, double-blinded placebo-controlled trial in hypopituitary patients. Clin Endocrinol (Oxf). 2020 Dec;93(6):672-677. doi: 10.1111/cen.14290. Epub 2020 Aug 3.
citation: Vestergaard ET, Gormsen LC, Jessen N, Lund S, Hansen TK, Moller N, Jorgensen JO. Ghrelin infusion in humans induces acute insulin resistance and lipolysis independent of growth hormone signaling. Diabetes. 2008 Dec;57(12):3205-10. doi: 10.2337/db08-0025. Epub 2008 Sep 5.
Clinical trial NCT02559245: Effect of Flixweed and Fig on Irritable Bowel Syndrome With Predominant Constipation: a Single Blind Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome Predominant Constipation
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates effect of Ficus carica and Descurainia Sophia on irritable bowel syndrome predominant constipation. one-third of patients will receive Ficus carica, another one-third will receive Descurainia Sophia and remained patients only will follow their regular diet for 4 months.


Eligibility criteria: Inclusion Criteria:

* patients with irritable bowel syndrome predominant constipation

Exclusion Criteria:

* Subjects with significant cardiovascular, renal, hepatic, pulmonary, endocrine, metabolic, hematologic disorders,
* structural abnormalities of the gastrointestinal tract or
* diseases ⁄conditions that affected bowel transition,
* surgery,
* any prokinetic or laxative drug used during the past month,
* any medication that may affect gastrointestinal motility,
* other therapeutic dietary advice for IBS,
* used Fig or Flixweed during the last month,
* diarrhea,
* pregnancy or
* breast-feeding

Primary outcomes:
measure: irritable bowel syndrome constipation predominant symptom
timeFrame: 4 months
Secondary outcomes:
measure: quality of life in IBS-C patients
timeFrame: 4 months
measure: frequency of defecation and hard stool
timeFrame: 4 months
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Gastrointestinal Research Center
Study officials:
affiliation: Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
name: makan pourmasoumi, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00848445: Atrial Fibrillation: Canadian Atrial Fibrillation Evaluation (CAFE) Study -
Official title: the Use of Atrial Fibrillation Pacing Therapies in Patients With no Previous History of Atrial Fibrillation: Canadian Atrial Fibrillation Evaluation (CAFE) Study -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2009-02-20
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: To evaluate whether atrial fibrillation (AF) therapies in Guidant Pulsar Max II or Insignia Plus DR have an effect on the occurance of AF in patients with no prior history of AF

Detailed description: This multi-centre, randomized, cross-over, prospective study will evaluate the occurrence of AF with AF pacing therapies programmed on (APP and VRR) and with AF therapies programmed off (APP and VRR) in patients with no known prior history of AF (all patients have a pacing indication). The occurrence of AF as well as time to first event and AF burden (frequecy and duration).

Eligibility criteria: Inclusion Criteria:

* No prior history of AF or atrial flutter, primary indication of SSS or AV block for dual chamber pacemaker, confidentiality agreement signed and dated before implant, available for follow-up at the study centre where they were enrolled at the protocol defined intervals, willing and capable of participating in all testing associated with the study, on stable regime of arrhythmia management drugs.

Exclusion Criteria:

* Documented history of AF or atrial flutter, clinically significant ventricular arrhythmias, \< 18 yrs old, life expectancy \< 1 year or expectation of heart transplantation during the study period, likely to or have received a mechanical tricuspid valve during the study, enrolled in other cardiovascular studies, women who are pregnant, inability or refusal to sign Patient Confidentiality Agreement, inability or refusal to complete the follow-up schedule at the study centre in which they were enrolled, exhibit arrhythmias due to reversible cause eg, digitalis toxicity, hypoxia, transient electrolyte imbalance, acute myocardial infarction or electrocution.

Primary outcomes:
measure: To compare the occurrence of AF (>350 bpm) during a period when AF pacing therapies are programmed on (APP and VRR) and during when AF therapies are programmed off.
timeFrame: one year
Secondary outcomes:
measure: To compare AF burden between patients with AF therapies programmed on (APP and VRR) and patients with AF pacing therapies turned off (APP and VRR). Burden is defined as the product of the number of AF events and duration of events. To compare the time to
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Victoria Cardiac Arrythmia trials
name: Lawrence Sterns, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05261945: Effects of Manual Therapy Versus Stretching Exercise Versus Routine Physical Therapy on Work-related Pain, Among Chefs
Official title: The Effects of Manual Therapy Versus Stretching Exercise Versus Routine Physical Therapy on Work-related Pain, Among Patients With Non-specific Chronic Neck Pain Working as Chefs: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Manual Therapy
Stretching Exercises
Routine Physical Therapy
Non Specific Chronic Neck Pain
Restaurant Chefs
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this research is to analyze the effect of Mulligan technique versus stretching techniques and versus routine physical therapy on pain, range of motion and functional disability among restaurant chefs presenting with non-specific chronic pain.

Detailed description: A Randomized Control Trail study will be conducted, at Riphah International University Faisalabad after the approval of synopsis. Purposive sampling will be used to enroll the patients. Patients will be selected according to the pre-defined inclusion and exclusion criteria. The patients who will meet the inclusion criteria are allocated into three groups. The patients of group A will receive Routine physical therapy only. Group B will receive manual therapy and routine physical therapy while Group C will receive stretching exercises and routine physical therapy. The outcomes will be measured by the Neck Disability Index, visual analogue scale and bubble inclinometer. The data of patients will be recorded pre-treatment and post-treatment. The comparison between pre-treatment and post-treatment data will be done after 3 months. Informed consent will be taken from each patient. Data entry and analysis will be done with Statistical Package of Social Sciences Version 20 software.

Eligibility criteria: Inclusion Criteria:

* For at least 3 months, you've been suffering from neck pain
* Any Neurological problems
* For the previous three months, the patient has taken some analgesic drug for neck pain.
* Rheumatological issues
* Non-specific neck pain
* Age 18-60 years

Exclusion Criteria:

Neck pain due to,

* Tumors
* Ankylosing Spondylitis
* Fracture
* Dislocation
* Cord compression
* Insufficiency of the vertebrobasilar artery
* Osteoprosis
* Anticoagulant or corticosteroid therapy for a long period of time
* Pain due to any congenital deformity, inflammation or any infection
* Carcinoma

Primary outcomes:
measure: Visual analog scale
timeFrame: 12th Week
measure: Neck disability index
timeFrame: 12th Week
measure: Bubble inclinometer
timeFrame: 12th Week
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References: