louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01372852: Plasma Adiponectin Concentration, Activity and Isoforms in Newly Diagnosed and Untreated Type 2 Diabetes Mellitus
Official title: Plasma Adiponectin Concentration, Activity and Isoforms in Newly Diagnosed and Untreated T2DM Patients in Chinese Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Keywords: Diabetes mellitus
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2011-06-14
Enrollment: 300
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This study enrolls a group of 30-70years patients from primary care clinic who have diabetes history within 12 months and without taking any treatment.

Brief summary: The objective of present study were to compare plasma adiponectin isoform status, their bioactivities newly diagnosed Chinese with healthy volunteer.

Detailed description: Adiponectin, circulates as trimer, hexamer and high molecular weight form (HMW) in human blood, is a promising biomarker for indication diabetes and cardiovascular disease. Both adiponectin complexes concentration and their bioactivities are decreased in pathological state. Disulﬁde-bond A oxidoreductase-like protein (DsbA-L) is a key regulator for adiponectin biosynthesis and its expression level is down-regulated in obese mice and humans. However, the alteration of circulating adiponectin multimers distribution, their bioactivities and adiponectin regulator, DsbA-L level, in newly diagnosed Chinese type 2 diabetes patients are unknown. The objective of present study were to compare plasma adiponectin isoform status, their bioactivities and DsbA-L concentration in newly diagnosed Chinese with healthy volunteer.

Eligibility criteria: Inclusion Criteria:

* Having a diabetic history within 12 months
* BMI smaller than 30kg/m2

Exclusion Criteria:

* Having any kinds of treatment affecting glucose
* pregnant
* uncontrolled hypertension, active cardiac disease, or other major liver, kidney disease

Primary outcomes:
measure: plasma adiponectin concentration, isoform distribution and activity.
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Department of Cardiology of Xijing Hospital, Fourth Military Medical University
name: Ling Tao, M.D Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05142852: Shock Wave Therapy in Individuals With Lateral Epicondylitis
Official title: Analgesic Effect of Extracorporeal Shock Wave Therapy in Individuals With Lateral Epicondylitis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Epicondylitis
Keywords: Pain
Function
Lead sponsor: Isra University, Jordan
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A sample of 40 patients poststroke (24 males) was randomly allocated to either ESWT experimental (n=18) or conventional physiotherapy control group (n=20). All patients received 5 sessions during the treatment program. The Visual Analog Scale (VAS) and Taiwan version Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, and dynamometer (Maximal grip strength) for each participant were assessed before and after the treatment program.

Detailed description: The participants in the experiment group received 5 consecutive sessions of ESWT for 5 minutes. Treatment parameters for the shock wave therapy group were set similar to a previous study (Devrimsel et al., 2013) 2000 shock waves with 1.6 bar intensity and 16 Hz frequency were applied for five sessions using the Swiss DolorClast Master (EMS, Nyon, Switzerland). The participants in the control group received 5 sessions of conventional physical therapy intervention for 5 minutes. The control group intervention consists of a 1-minute friction massage over the common extensor tendon of the elbow, followed by 3 minutes therapeutic ultrasound with a frequency of 1.5 Hz, and a 1-minute ice massage over the common extensor tendon of the elbow. All participants used 10-cm lateral epicondyle bandages in the treatment period, while none of them received analgesic or anti-inflammatory drugs and received exercise programs.

Eligibility criteria: Inclusion Criteria:

* An inclusion criterion was a confirmed diagnosis of lateral epicondylitis with lateral elbow pain lasting more than 6 months and less than 1 year.

Exclusion Criteria:

* Participants were excluded from this study if they had cervical radiculopathy, elbow deformity, history of diabetes mellitus, hypo- or hyperthyroidism, history of malignancy, chronic inflammatory diseases, and pregnancy. Patients who received corticosteroid injections to the lateral epicondyle within 6 weeks were also excluded.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Change from baseline Visual Analog Scale at 5 day
Secondary outcomes:
measure: Upper extremity disability and symptoms
timeFrame: Change from baseline Upper extremity disability and symptoms at 5 day
measure: Maximal grip strength
timeFrame: Change from baseline maximal grip strength at 5 day
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Isra University
Study officials:
affiliation: Isra University, Jordan
name: Salameh Aldaja, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00520052: Frequency of Zoledronic Acid to Prevent Further Bone Loss in Osteoporotic Patients Requiring Androgen Deprivation Therapy for Prostate Cancer
Official title: Frequency of Zoledronic Acid to Prevent Further Bone Loss in Osteoporotic Patients Requiring Androgen Deprivation Therapy for Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: bisphosphonates, prostate cancer, bone density, osteoporosis
Lead sponsor: Wirral University Teaching Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2007-08-23
Enrollment: 58
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine if 3 monthly infusions of zoledronic acid, given over one year, improves the bone mineral density in osteoporotic patients undergoing androgen deprivation therapy for prostate cancer

Detailed description: Androgen Deprivation Therapy is the mainstay of treatment for advanced prostate cancer. However they are associated with accelerated bone loss, osteoporosis and fractures. Previous studied looking at the use of zoledronic acid have predominantly studied men with a normal or osteopenic bone mineral density. However, it has been shown that upto 40% of men presenting with prostate cancer have osteoporosis and it is these who are at most risk of osteoporotic fractures. Our aim was to evaluate the efficiency of zoledronic acid in 2 groups of osteoporotic patients, those undergoing treatment with LHRH agonists and with antiandrogens.Peripheral and axial bone densitometry will be used to measure percentage changes in bone mineral density over 3 years. The first year with the patients on LHRH or antiandrogen, the second year continuing with their androgen deprivation therapy and zoledronic acid. Then bone mineral density will be measured one year following the last infusion of zoledronic acid to ascertain the optimum frequency of administration.

The study will also involve monitoring serum and urine bone turnover markers.

Eligibility criteria: Inclusion Criteria:

* patients with locally advanced prostate cancer who progress from normal/ osteopenic bone mineral density to osteoporosis while on LHRH agonists (LHRH Group). Also patients who have been commenced on Bicalutamide due to osteoporosis at presentation (Bicalutamide Group)

Exclusion Criteria:

* patients with elevated prostate specific antigen, any illness or medication that would affect bone and mineral metabolism, previous bisphosphonate treatment, severe hepatic or renal insufficiency.

Primary outcomes:
measure: axial and peripheral bone mineral density
timeFrame: over 3 years
Secondary outcomes:
measure: serum and urine bone turnover markers
timeFrame: over 1 year
Other outcomes:
Locations:
city: Upton, Wirral
country: United Kingdom
facility: Wirral Hospitals Universirt NHS Trust
state: Merseyside
Study officials:
affiliation: Wirral Hospital University NHS Trust
name: Nigel J Parr, MBBS, FRCS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05835232: Sleep Disorders and Psychophysical Well-being in HIV+ Patients
Official title: Sleep Disorders, Mental Health and Quality of Life in a Court of HIV+ Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infections
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We expect the majority of the HIV patient population to be male, between the ages of 40 and 65 and with a high school diploma. We expect a virologically suppressed HIV population with good adherence to antiretroviral therapy. We expect poor sleep quality and low quality of life and high symptoms of depression, anxiety and stress.

Brief summary: The primary goal of this observational study is to investigate sleep quality in patients living with HIV+. The secondary objective is to measure the influence of sleep quality on indicators of mental health (anxiety, depression and stress) and quality of life.

The main questions it aims to answer are:

* Measuring the effects of poor sleep quality on mental and physical health in HIV+ patients.
* Monitor the sleep pattern in the HIV+ population.

Participants will fill out an online cross-sectional survey.

The online questionnaire survey will collect:

* sociodemographic and clinical data related to HIV infection,
* sleep quality,
* mental health,
* quality of life.


Eligibility criteria: Inclusion Criteria:

* HIV diagnosis.
* Being treated at the Infectious Diseases Outpatient Clinic of Policlinico Gemelli in Rome.
* Ongoing antiretroviral therapy.
* Age \> 18 years.
* Native Italian speaker.
* Informed consent to participate in the study

Exclusion Criteria:

* Absence of an HIV diagnosis.
* Not being treated at the Infectious Diseases Outpatient Clinic of Policlinico Gemelli in Rome.
* Absence of ongoing antiretroviral therapy.
* Age \> 18 years.
* Not being a native Italian speaker.
* Refusal to sign informed consent

Primary outcomes:
measure: Sleep quality
timeFrame: 1 year
Secondary outcomes:
measure: Influence of sleep quality on mental health
timeFrame: 1 year
measure: Influence of sleep quality on quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
References:
Clinical trial NCT00862732: Study to Prevent Negative Thoughts of Life
Official title: A Randomised Controlled Trial With Cognitive Behavioural Therapy for Persons With Active Suicidal Ideations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Active Suicidal Ideations
Keywords: active suicidal ideation
cognitive behavioural therapy
Sri Lanka
RCT
Lead sponsor: Institute for Research & Development Sri Lanka
Sponsor class: OTHER
Collaborators: name: Institute of Psychiatry, London
First posted: 2009-03-17
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to test whether cognitive behaviour therapy (CBT) offered by trained therapists, to people with current active suicidal ideations, is efficacious as a secondary prevention strategy in Sri Lanka, when compared with treatment as usual provided by Medical Officers (Mental Health; MO (MH)) of government hospitals


Eligibility criteria: Inclusion Criteria:

* Age between 18 - 64 years
* Self reported current active suicidal ideations
* Ability to speak and write Sinhala

Exclusion Criteria:

* An acute intent and planning of suicide
* In-patient/out-patient treatment following an attempted suicide during the previous two-year period
* A diagnosis of mental retardation
* A diagnosis of sensory deficit
* A diagnosis of alcohol abuse
* A diagnosis of psychotic illness

Primary outcomes:
measure: Presence of active suicidal ideations during the follow-up period
timeFrame: three months after the cessation of intervention
Secondary outcomes:
measure: Impulsiveness Suicide attempts and completed suicides Client satisfaction Probability of common mental disorders Adherence to treatment regime Retention in the treatment regime Quality of life
timeFrame: three months after the cessation of intervention
Other outcomes:
Locations:
city: Battaramulla
country: Sri Lanka
facility: Institute for Research & Development
Study officials:
affiliation: Institute for Research & Development Sri Lanka
name: Sudath Samaraweera, MBBS MSc MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05126732: Ganglion Cell Thickness in Enuresis Nocturna
Official title: Is Ganglion Cell Thickness the Main Problem in Enuresis Nocturna?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Enuresis, Nocturnal
Ganglion
Circadian Rhythm Disorders
Keywords: enuresis
optical coherence tomography
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients aged 5-18 years, with enuresis, without any eye disease

Brief summary: The precise role of the intrinsic circadian regulatory mechanism behind the pathogenesis of enuresis is not fully understood, but in theory, circadian rhythm irregularity may be the primary pathogenic mechanism not only for urinary outflow mechanisms but also for nocturnal bladder function. The proximity between SCN centers that control AVP release, sleep/arousal, voiding, and baroreregulation may provide the basis for circadian rhythm disturbance in one or more of these biological functions. Ganglion cells containing melanopsin pigment in the retina transmit the information they receive from the outside world about the light-dark state to the SCN via the retinohypothalamic pathway. Peripapillary retinal nerve fiber layer (RNFL) thickness, optic nerve head and macula are examined most frequently for the diagnosis of glaucoma and the detection of progression with optical coherence tomography (OCT). If differences in ganglion cell thickness can be detected using OCT in these children, a new avenue in Enuresis Nocturna may be opened.


Eligibility criteria: Inclusion Criteria:

* be between the ages of 5-18
* have enuresis

Exclusion Criteria:

* have any eye conditions

Primary outcomes:
measure: Difference in ganglion cell thickness in enuretic children
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Bakircay University
Study officials:
References:
Clinical trial NCT00900432: Immune Response in Peripheral Blood of Patients With Colon Cancer
Official title: Immune Studies of Peripheral Blood From Patients With Malignant Disease Gastrointestinal Tract
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: recurrent colon cancer
stage I colon cancer
stage II colon cancer
stage III colon cancer
stage IV colon cancer
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 67
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: colon cancer

Brief summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that may occur in the immune system that may help kill cancer cells.

PURPOSE: This laboratory study is looking at anticancer immune responses in the peripheral blood of patients with colon cancer.

Detailed description: OBJECTIVES:

* Quantify T cells specific for tumor peptides (carcinoembryonic antigen and MUC1) from the peripheral blood of patients with colon cancer.

OUTLINE: This is an open-label study.

Patients undergo blood collection at time of follow-up, surgery, thoracentesis, paracentesis, or leukapheresis (≤ 5 times per year). Blood is analyzed for tumor peptides (carcinoembryonic antigen and MUC1), circulating cytokines, and lymphocyte response by ELISA, ELISPOT, or intracellular flow.

PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of colon cancer

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Quantitation of T cells specific for tumor peptides (carcinoembryonic antigen and MUC1)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center at University of Arizona Health Sciences Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Michael Demeure, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05602532: Triglyceride-Glucose Index in Diabetic Nephropathy in Type 2diaberes Mellitus Patients
Official title: Triglyceride-Glucose Index in Diabetic Nephropathy in Type 2diaberes Mellitus Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There will be no risk for the patients during the study Confidentiality will be assured. The participants will be informed about the research and they will hsve the right to refuse to participate.

Written consents will be obtained from all the participants; illiterate participants will give their consent by fingerprints.

Brief summary: The aim of the present study is to investigate the associations between the TyG index and diabetic nephropathy in patients with type2 DM .

Detailed description: the triglyceride-glucose (TyG) index was proposed as a simple and reliable surrogate marker of IR, and it has been reported to be closely correlated with the HOMA-IR index. The TyG index has the advantage of being applicable in clinical practice since both triglyceride and glucose levels are routinely measured and the cost of these measurements is low.

Eligibility criteria: Inclusion Criteria:

* patients with type 2 DM

Exclusion Criteria:

- (1) Individuals with obstructive uropathy, severe heart failure, stroke, liver disease, cancer, autoimmune disease (2) Pregnant woman. (3)End stage renal disease patients on dialysis ( glomerular filtration rate \<15 mL/min/1.73 m2) or renal transplantation.

(4) Type 1 Diabetic patient. (5) Albuminuria due to non-diabetic renal disease

Primary outcomes:
measure: TyG index in type 2diaberes Mellitus
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Zheng Y, Ley SH, Hu FB. Global aetiology and epidemiology of type 2 diabetes mellitus and its complications. Nat Rev Endocrinol. 2018 Feb;14(2):88-98. doi: 10.1038/nrendo.2017.151. Epub 2017 Dec 8.
citation: Beckman JA, Creager MA, Libby P. Diabetes and atherosclerosis: epidemiology, pathophysiology, and management. JAMA. 2002 May 15;287(19):2570-81. doi: 10.1001/jama.287.19.2570.
citation: Yamagishi S, Imaizumi T. Diabetic vascular complications: pathophysiology, biochemical basis and potential therapeutic strategy. Curr Pharm Des. 2005;11(18):2279-99. doi: 10.2174/1381612054367300.
citation: Liang S, Cai GY, Chen XM. Clinical and pathological factors associated with progression of diabetic nephropathy. Nephrology (Carlton). 2017 Dec;22 Suppl 4:14-19. doi: 10.1111/nep.13182.
citation: Lee MY, Hsiao PJ, Huang JC, Hsu WH, Chen SC, Chang JM, Shin SJ. ASSOCIATIONS BETWEEN TRIGLYCERIDE/HIGH-DENSITY LIPOPROTEIN CHOLESTEROL RATIO AND MICRO- AND MACROANGIOPATHIES IN TYPE 2 DIABETES MELLITUS. Endocr Pract. 2018 Jul;24(7):615-621. doi: 10.4158/EP-2017-0254.
Clinical trial NCT01621932: Anterior Capsulectomy vs. Repair in Direct Anterior THA
Official title: Anterior Capsulectomy vs. Repair in Direct Anterior THA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Arthroplasty
Keywords: Anterior approach
Lead sponsor: OrthoCarolina Research Institute, Inc.
Sponsor class: OTHER
First posted: 2012-06-18
Enrollment: 82
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: Randomized prospective study comparing the anterior capsule repair vs capsulectomy with regards to post-operative pain and range of motion outcomes in elective primary unilateral direct anterior approach THA for osteoarthritis. Visual Analog Scores (VAS) will be recorded for preoperative and postoperative months 1 and 4. Hip range of motion will be assessed by goniometer measurements and lateral hip radiographs in maximum flexion.

The purpose of the study is to compare post-operative pain control and hip range of motion between two surgical techniques (anterior capsular repair vs. anterior capsulectomy) during direct anterior total hip arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Elective unilateral primary total hip arthroplasty Direct anterior surgical approach Osteoarthritis diagnosis 18 years of age or older

Exclusion Criteria:

* Bilateral primary total hip arthroplasty Revision hip arthroplasty Avascular necrosis of the hip Rheumatoid arthritis of the hip Younger than 18 years of age

Primary outcomes:
measure: Hip flexion
timeFrame: postoperative 4 months
Secondary outcomes:
measure: Visual analog scale-pain
timeFrame: 4 months and 12 months post operative
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina, P.A.
state: North Carolina
Study officials:
affiliation: OrthoCarolina, P.A.
name: John Masonis, MD
role: PRINCIPAL_INVESTIGATOR
References: