louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04436692: Dietary Intervention and Adults With Intellectual Disabilities
Official title: Dietary Intervention in Overweight Subjects With Intellectual Disabilties Using the Nudging Approach as Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intellectual Disabilities Nutritional
Intellectual Disability
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Goal The overall aim of the study is to improve the health of persons with Intellectual disabilities

Detailed description: Purpose

There are two main purposes of the study The first is to study the diet and heath of persons with intellectual disabilities. The second is to increase their knowledge on nutrition and health and that of service providers in municipalities housing facilities and to test, in an intervention, the effects of a method for weight reduction in adult persons with intellectual disabilities with overweight and obesity. Physical activity is also an important factor in weight reduction, but this study focuses only on nutrition, to obtain new information on this one factor in weight reduction. A combined study with many changes in a short period of time is very challenging for the group in question.

The vision is that results from this study will lead to improved health promotive and preventive services in the municipality in the future, to adult persons with intellectual disabilities and that this study also can have effects on services also for other groups, such as those with the fields of psychiatry and drug problems.

Eligibility criteria: Inclusion criteria:

* Mild intellectual disability and overweight
* Moderate intellectual disability and overweight

Exclusion Criteria:

* Metabolic diseases
* Hypertension
* Diabetes

Primary outcomes:
measure: Change in body weight by using a nudging approach in adults with intellectual disabilities
timeFrame: One year
Secondary outcomes:
measure: Change in consumption of fruits and vegetables as measured using dietary survey
timeFrame: One year
Other outcomes:
measure: Change in consumption of sugar containing beverages as measured using dietary survey
timeFrame: One year
Locations:
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
affiliation: Institute of Basic Medical Sciences
name: Lene F Andersen, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00552292: Complications in Hypertension and Obesity
Official title: National Investigation of Cardiovascular Complications in Arterial Hypertension and Obesity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metabolic Syndrome
Hypertension
Obesity
Dyslipidemia
Hyperglycemia
Keywords: metabolic syndrome
hypertension
obesity
dyslipidemia
hyperglycemia
cardiovascular complications
Lead sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Sponsor class: OTHER
First posted: 2007-11-01
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age and sex-matched sample of subjects older 18 age

Brief summary: The study in aimed to investigate epidemiology of risk factors in Russian Federation its prognostic value aimed on acceptance of national specific definition of metabolic syndrome and guidelines for its management.


Eligibility criteria: Inclusion Criteria:

* Age older 18 years
* Signed informed consent
* Blood pressure more than 130 and/or 85 mm Hg
* Waist circumference more than 80 sm in females and 94 in males and/or BMI more than 25 kg/m2
* Dyslipidemia (elevated TG and/or decreased level of HDLP or therapy for high triglyceride level)
* Fasting glucose more than 5,6 mmol/l

Exclusion Criteria:

* Associated clinical conditions (stroke, TIA, MI, heart failure, renal disease, diabetes mellitus)
* Severe concomitant diseases affecting outcome

Primary outcomes:
measure: cardiovascular complications
timeFrame: 2007-2017
Secondary outcomes:
measure: diabetes mellitus
timeFrame: 2007-2017
Other outcomes:
Locations:
city: St.Petersburg
country: Russian Federation
facility: Almazov Federal Center of Heart, Blood and Endocrinology
Study officials:
affiliation: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
name: Eugene V Shlyakhto
role: STUDY_DIRECTOR
References:
Clinical trial NCT00830492: Clomiphene Citrate (CC)/Gonadotropin/Gonadotropin Releasing Hormone (GnRH) Antagonist Versus Gonadotropin/GnRH Agonist
Official title: Comparisin CC/Gonadotropin/GnRH Antagonist and Gonadotropin/GnRH Agonist in IVF Outcome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ovarian Stimulation
Keywords: clomiphene citrate
GnRH agonist
GnRH antagonist
in vitro fertilization
clinical pregnancy
pregnancy
Lead sponsor: Yazd Research & Clinical Center for Infertility
Sponsor class: OTHER
First posted: 2009-01-28
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To compare the efficacy of using mild ovarian stimulation protocol and conventional stimulation protocol in IVF outcome.

Design: Prospective randomized trial

Setting: University IVF setting. Patient(s): The study compromised a total 200 subinfertile couple that women had regulary menstruation.

Intervention(s): Patients were randomized to treatment clomiphene citrate, gonadotropin and GnRH antagonist (100 patients) or GnRH agonist and gonadotropin ( 100 patients).

Main outcome measure: Clinical pregnancy rate.

Key Words: clomiphene citrate, GnRH agonist, GnRH antagonist, in vitro fertilization, pregnancy rate.


Eligibility criteria: Inclusion Criteria:

* female patient age 18-35 years, presence of a regular and proven ovulatory menstruation cycle with a length of 26-35 days
* basal FSH \<10 IU/L and body mass index (BMI) of 18-30 (kg/m²)
* Indication for IVF were unexplained infertility, mild male factor, tubal factor, early stage endometriosis and cervical factor

Exclusion Criteria:

* patient requiring ICSI

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: 2 weeks
measure: ovarian stimulation safety
timeFrame: 3weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Yazd
country: Iran, Islamic Republic of
facility: Yazd Research and Clinical Center For Infertility
Study officials:
References:
Clinical trial NCT01531192: Comparison of Lactobacillus Reuteri and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants
Official title: Zekai Tahir Burak Maternity Teaching Hospital, Ankara/Turkey
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Very Low Birth Weight Infants
Keywords: Lactobacillus reuteri
Nystatin
Very Low Birth Weight Infants
Candida Colonization
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2012-02-10
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Lactobacillus reuteri was shown to reduce candida colonization. The objective of this study is to evaluate the efficacy of prophylactic Lactobacillus reuteri in reducing the candida colonization and infection in very low birth weight infants.


Eligibility criteria: Inclusion Criteria:

* Very low birth weight infants \< 1500 gr
* Gestational age \< 32 weeks

Exclusion Criteria:

* Genetic anomalies
* Short bowel syndrome
* Not willing to participate
* Allergy to Lactobacillus reuteri components

Primary outcomes:
measure: Comparison of prophylactic Lactobacillus reuteri and nystatin on candida colonization and infection in very low birth weight infants
timeFrame: up to 6 months
Secondary outcomes:
measure: Effect of Lactobacillus reuteri on feeding intolerance
timeFrame: up to 6 months
measure: Effect of Lactobacillus reuteri on sepsis
timeFrame: up to 6 months
measure: Effect of Lactobacillus reuteri on length of hospital stay
timeFrame: up to 6 months
measure: Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology
Study officials:
affiliation: Neonatology
name: Mehmet Yekta Oncel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oncel MY, Arayici S, Sari FN, Simsek GK, Yurttutan S, Erdeve O, Saygan S, Uras N, Oguz SS, Dilmen U. Comparison of Lactobacillus reuteri and nystatin prophylaxis on Candida colonization and infection in very low birth weight infants. J Matern Fetal Neonatal Med. 2015;28(15):1790-4. doi: 10.3109/14767058.2014.968842. Epub 2014 Oct 9.
Clinical trial NCT02394392: Clinical Characteristics and Medication Satisfaction of Kanarb Tablet in Korean Hypertensive Patient(Kanarb-Hypertension Epidemiology Medication Satisfaction Study)
Official title: Clinical Characteristics and Medication Satisfaction of Kanarb Tablet in Korean Hypertensive Patient: a Prospective, Cross-sectional and Open-label 8 Week Switching Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Medication satisfaction
Quality of life
Drug compliance
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2015-03-20
Enrollment: 12691
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 14,000 hypertensive patients anticipated 30% of hypertensive patients who does not satisfied their anti-hypertensive drugs

Brief summary: 1. Investigate the clinical characteristics, medication satisfaction and quality of life of anti-hypertensive drugs in Korean hypertensive patients
2. Observe the changes of medication satisfaction and compliance in patients after switchting to Fimasartan


Eligibility criteria: Inclusion Criteria:

Step1

* Over 20 years old
* Essential hypertensive patients who taking anti-hypertensive drugs during previous 1 month

Step2

* Patients does not taking Fimasartan
* Patient's medication satisfaction score under 4

Exclusion Criteria:

* Patients with secondary hypertension
* Patients with orthostatic hypotension who has sign and symptom
* Patients with known severe or malignancy retinopathy
* Patients with significant investigations; abnormal renal function
* Childbearing and breast-feeding women
* Patients with history of allergic reaction to any angiotensin II antagonist

Primary outcomes:
measure: quality of life questionnaire for hypertension
timeFrame: up to 1 month
measure: medication satisfaction questionnaire
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Drug compliance questionnaire
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea university Guro hospital
Study officials:
References:
citation: Oh DJ, Han SE, Jeong SH, Hong MS, Choe SC. Clinical characteristics and satisfaction with the fimasartan in Korean hypertensive patients: a prospective, cross-sectional and open-label, 8-week switching study (Kanarb-hypertension epidemiology medication satisfaction study; K-HEMS study). Clin Hypertens. 2018 Sep 1;24:10. doi: 10.1186/s40885-018-0096-2. eCollection 2018.
Clinical trial NCT06101992: Mesoglycan for Acute Hemorrhoidal Disease
Official title: Randomized Double-blind Controlled Clinical Trial: the Use of Mesoglycan vs Placebo in the Acute Phase of Hemorrhoidal Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemorrhoids
Lead sponsor: Societa Italiana di Chirurgia ColoRettale
Sponsor class: NETWORK
Collaborators: name: Neopharmed Gentili S.p.A.
First posted: 2023-10-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double-blind controlled clinical trial
Primary purpose: TREATMENT

Brief summary: Hemorrhoidal disease (HD) is the most common proctological disease with a prevalence rate that can reach approximately 4.4% of the population, with a particular peak in individuals aged between 45 and 65 years. The most common presentation of HD is painless rectal bleeding occurring during or immediately after defecation. Pain is rare in case of uncomplicated HD and may be present in case of external hemorrhoidal thrombosis.

The decision-making to treat Hemorrhoidal thrombosis usually depends on the timing of the onset of symptoms, with the surgical treatment favored if the onset of symptoms occurs within 72 hours.

Mesoglycan, a natural preparation of glycosaminoglycans (GAGs), is a polysaccharide complex rich in sulfur radicals.

It is composed of heparan sulphate (47.5%), dermatan sulphate (35.5%), chondroitin sulfate (8.5%) and slow heparin (8.5%).

Mesoglycan exerts antithrombotic activity (activation of antithrombin III and heparin cofactor II) and profibrinolytic (stimulation of the activator tissue plasminogen) decreasing plasma concentrations of fibrinogen without affecting the prothrombin time, the time of partial thromboplastin or the remaining coagulation parameters. The rationale of this double-blind randomized controlled clinical trial is to confirm/evaluate the efficacy and safety of mesoglycan versus placebo in reducing the symptoms of hemorrhoidal disease and their impact on quality of life.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of grade I-III hemorrhoidal disease classified according to Goligher classification or diagnosis of external hemorrhoid thrombosis
* Female patients of childbearing age with a negative pregnancy test
* Patients able to understand informed consent
* Signed Informed Consent.

Exclusion Criteria:

* Blood coagulations disorders
* Patients undergoing chemoradiation
* intake of anticoagulants
* pregnancy

Primary outcomes:
measure: Symptoms relief
timeFrame: 40 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Societa Italiana di Chirurgia ColoRettale
name: Arcangelo Picciariello, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02437292: Effect of Ischemic Compression With Stretching on Patients With Upper Back Pain
Official title: Effect of Ischemic Compression With Stretching on Pain Related Parameters in Patients With Upper Back Pain Associated With Myofascial Trigger Point
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myofascial Pain Syndrome
Lead sponsor: Mae Fah Luang University Hospital
Sponsor class: OTHER
First posted: 2015-05-07
Enrollment: 30
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: The purpose of this study is to determine the effect of ischemic compression with stretching on pain related parameters including pain intensity, pressure pain threshold, anxiety, cervical range of motion and patient satisfaction in patients with scapular pain associated with myofascial trigger point.


Eligibility criteria: Inclusion Criteria:

* The participants have experienced spontaneous upper back pain for longer than 12 weeks (chronic) and that at least one trigger point will be present in the s trapezius muscles. Trigger points will be diagnosed as the presence of focal tenderness in a taut band and with pain recognition.
* The participants will be able to follow instructions.
* Good communication and cooperation.

Exclusion Criteria:

* Fibromyalgia syndrome
* Cervical radiculopathy or myelopathy)
* Cervical spine surgery

Primary outcomes:
measure: Pain score on Visual analog scale
timeFrame: 5 weeks
Secondary outcomes:
measure: Pressure Pain Threshold as a measure by pressure algometry
timeFrame: 5 weeks
measure: Anxiety on State Anxiety Inventory
timeFrame: 5 weeks
measure: Cervical range of motion
timeFrame: 5 weeks
measure: Patient satisfaction level
timeFrame: 5 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Mae Fah Luang University
name: VITSARUT BUTTAGAT, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04262492: International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants
Official title: OBServaToire INternational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Antiphospholipid Syndrome
Thrombosis
Anticoagulants Causing Adverse Effects in Therapeutic Use
Keywords: antiphospholipid syndrome
direct oral anticoagulants
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: International Society on Thrombosis and Haemostasis
First posted: 2020-02-10
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thrombotic APS patients according to revised Sapporo-Sydney criteria

Brief summary: This registry, currently being established will ensure consistency of data collection and provide safety information in non high-risk APS patients currently on DOACs.


Eligibility criteria: Inclusion Criteria:

* Patient receiving a comprehensive information about the study, and not opposed to participate
* Age ≥ 18 yo
* Classification of definite APS according to revised Sapporo-Sydney criteria
* Direct oral anticoagulant treatment prescribed during at least 6 months or with the possibility of follow-up of at least 6 months

Exclusion Criteria:

* Incomplete revised Sapporo-Sydney criteria
* No data regarding the recurrent thrombosis
* Pregnant woman
* Age \< 18 yo

Primary outcomes:
measure: Rate of Recurrent Thrombosis
timeFrame: 6 months
Secondary outcomes:
measure: Rate of Bleeding
timeFrame: 6 months
measure: Rate of Non-Criteria Manifestations
timeFrame: 6 months
measure: Adherence to treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Nancy
country: France
facility: Stéphane Zuily
Study officials:
References:
citation: Dufrost V, Risse J, Reshetnyak T, Satybaldyeva M, Du Y, Yan XX, Salta S, Gerotziafas G, Jing ZC, Elalamy I, Wahl D, Zuily S. Increased risk of thrombosis in antiphospholipid syndrome patients treated with direct oral anticoagulants. Results from an international patient-level data meta-analysis. Autoimmun Rev. 2018 Oct;17(10):1011-1021. doi: 10.1016/j.autrev.2018.04.009. Epub 2018 Aug 11.
citation: Dufrost V, Risse J, Wahl D, Zuily S. Direct Oral Anticoagulants Use in Antiphospholipid Syndrome: Are These Drugs an Effective and Safe Alternative to Warfarin? A Systematic Review of the Literature: Response to Comment. Curr Rheumatol Rep. 2017 Aug;19(8):52. doi: 10.1007/s11926-017-0676-2. No abstract available.
Clinical trial NCT05808192: De Novo Metabolic Syndrome in Liver Transplant Patients After Immunosuppression Withdrawal
Official title: De Novo Metabolic Syndrome in Liver Transplant Patients After Immunosuppression Withdrawal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Single Transplant
5 Years of Follow-up After Transplant, in Which an Attempt Was Made to Suspend IS
Keywords: Metabolic Syndrome, Liver transplantation, Immunosoppression, Tolerance
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 92
Sex: ALL
Minimum age (years): 49
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 92 patients with liver transplantation who attempted to suspend/ achieve suspension of immunosuppressive therapy, in follow-up in Tor Vergata transplant center.

Brief summary: Evaluate de novo onset of metabolic syndrome, NAFLD and NASH in liver transplant recipients who have discontinued immunosuppressive therapy ("tolerant") and in those taking immunosuppressive therapy ("non-tolerant").

Detailed description: A retrospective single-center study was conducted aiming to define the incidence of de novo Metabolic Syndrome (MS) in patients who withdraw Immunosoppression (IS) drugs after Liver Transplant (Tolerant-group) compared to these who couldn't wean IS drugs(non-TOL-group).

Eligibility criteria: Inclusion Criteria:

* single LT recipients with an attempt of IS withdrawal
* minimum 5 years follow-up

Exclusion Criteria:

* Liver transplant combined with other organs
* Presence of metabolic syndrome and/or NASH and/or NAFLD as an indication for liver transplantation
* Loss of patient to follow-up

Primary outcomes:
measure: relation between MS development and IS in LT recipients
timeFrame: 5 years
Secondary outcomes:
measure: IS withdrawal in LT recipients
timeFrame: 5 years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Roberta Angelico
Study officials:
References: