louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04319107: Classifying Ectopia Lentis in Marfan Syndrome Into Five Grades of Increasing Severity
Official title: Classifying Ectopia Lentis in Marfan Syndrome Into Five Grades of Increasing Severity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Marfan Syndrome
Ectopia Lentis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: MFS patient or Relatives of MFS patients

Brief summary: Marfan syndrome is characterized by musculoskeletal manifestations, cardiovascular disease and ocular abnormalities, particularly ectopia lentis. Diagnosis depends on clinical evaluation, family history and molecular data: mutation in the fibrillin-1 gene (FBN1). Ectopia lentis is the most common ocular manifestation in Marfan syndrome with FBN1 mutation and is relatively specific to this disease when associated with other features. However, clinical examinations for identifying ectopia lentis have not really been codified. The purpose of this study is to describe a 5-grade classification of increasing severity for ectopia lentis based on clinical examination and to evaluate the predictive value for the early grades of ectopia lentis in order to help characterize this major clinical diagnosis criterion.


Eligibility criteria: Inclusion Criteria:

* MFS patient, clinical diagnosis according to revised Ghent criteria, confirmed by FBN1 mutation.
* Relatives of MFS patients with none of the clinical features of MFS and in whom testing for the familial FBN1 mutation was negative.

Exclusion Criteria:

* Patients who had surgery for ectopia lentis
* Patients for whom dilation was not optimal.

Primary outcomes:
measure: Ectopia lentis measurement
timeFrame: day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Femme Mère Enfant
Study officials:
affiliation: Hospices Civils de Lyon
name: Audrey Putoux, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zech JC, Putoux A, Decullier E, Fargeton AE, Edery P, Plauchu H, Dupuis-Girod S. Classifying Ectopia Lentis in Marfan Syndrome into Five Grades of Increasing Severity. J Clin Med. 2020 Mar 6;9(3):721. doi: 10.3390/jcm9030721.
Clinical trial NCT06162507: Study of CM310 in Children Subjects With Moderate-to-severe Atopic Dermatis
Official title: A Multicenter, Single-arm, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacokinetics of CM310 in Children Subjects With Moderate-to-severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2023-12-08
Enrollment: 24
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, single arm, open-label study to evaluate safety in children patients with moderate-to severe atopic dermatis.


Eligibility criteria: Inclusion Criteria:

* With atopic dermatis.
* Voluntarily sign the informed consent form.

Exclusion Criteria:

* Any major surgery planned during the research period.
* With intestinal parasitic infection within the first 6 months of screening.
* With any previous malignant tumors prior to screening.
* With any circumstance that is not suitable to participate in this study.

Primary outcomes:
measure: Adverse events
timeFrame: up to week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children's Hospital Capital Medical University
Study officials:
References:
Clinical trial NCT03310307: Vitamin D3 Treatment and Homocysteine Concentrations Among Overweight Reproductive Women
Official title: Vitamin D3 Treatment Decreases Serum Total Homocysteine Concentrations of Overweight Reproductive Women: Randomized Placebo Controlled Clinical Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Homocystinaemia
Vitamin D Deficiency
Keywords: Homocysteine
Overweight
vitamin D3
Reproductive women
RCT
Lead sponsor: Al-Balqa Applied University
Sponsor class: OTHER
Collaborators: name: Jordan University of Science and Technology
First posted: 2017-10-16
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 100 overweight reproductive vitamin D deficient women were divided into two groups; vitamin D (n = 50) and placebo (n = 50). Vitamin D group received treatment dose of 50,000 IU of vitamin D3 per week for 2 consecutive months and placebo group received placebo tablets similar in size, shape and color to vitamin D3 for 2 months also. Total homocysteine concentrations were measured before intervention (basal), on 30 days (one month) and on 60 days (2 months) of intervention. Changes in means of homocysteine concentrations for placebo and vitamin D group over time showed significant difference on 30 and 60 days of intervention. Mean comparisons of homocysteine concentrations and standard error of the means before and after intervention showed statistical significant decrease in homocysteine concentrations among vitamin D group.


Eligibility criteria: Inclusion Criteria:

* Overweight (BMI between 25-29.99 kg/m2)
* Had 25(OH)D \< 20 ng/mL
* Had normal vitamin B-12 and folic acid levels
* Not diagnosed with any chronic diseases
* Agreed to participat in the study

Exclusion Criteria:

* age \< 18 or \> 49 years
* BMI \> 30 kg/m2 or \< 25 kg/m2
* 25 (OH)D level \> 20 ng/ml
* tHcy levels greater than 100 µmol/L
* Abnormal vitamin B-12 or folic acid levels
* Chronic diseases
* Pregnant or lactating

Primary outcomes:
measure: 25(OH)D3
timeFrame: 2 months
Secondary outcomes:
measure: Homocysteine
timeFrame: 2 months
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: King Abdullah University Hospital
Study officials:
affiliation: JUST
name: Jehan M Hamadneh, FRCOG
role: PRINCIPAL_INVESTIGATOR
affiliation: BAU
name: Nahla S Al-Bayyari, PhD
role: STUDY_CHAIR
References:
citation: Al-Bayyari N, Al-Zeidaneen S, Hailat R, Hamadneh J. Vitamin D3 prevents cardiovascular diseases by lowering serum total homocysteine concentrations in overweight reproductive women: A randomized, placebo-controlled clinical trial. Nutr Res. 2018 Nov;59:65-71. doi: 10.1016/j.nutres.2018.07.012. Epub 2018 Jul 29.
Clinical trial NCT02248207: Tolerability of Sifrol® in Ambulatory Patients Suffering From Parkinson's Disease
Official title: Management of Parkinson's Disease Patients at Their First Visits in a Neurological Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-25
Enrollment: 1293
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinson's disease recruited at specialist neurologist (private practices and clinics)

Brief summary: Study to obtain information about the co-operation of the different physician-colleagues in the treatment of patients with Parkinson's disease, both in private practices and clinics and about the primary treatment strategies in the pharmacotherapy of Parkinson's disease and to collect data on the tolerability of Sifrol® in ambulatory patients suffering from Parkinson's disease under routing conditions


Eligibility criteria: Inclusion Criteria:

* Patients with Parkinson's disease who present to the specialist neurologist practice for the first time without or with referral and who are planned to receive or either be switched to Sifrol or continue the previously prescribed therapy with Sifrol® can be included in this observational study

Exclusion Criteria:

* Neurologists are asked to consider the Summary of Product Characteristics (SPC) for Sifrol®

Primary outcomes:
measure: Global Assessment of efficacy by investigator on a 4-point scale
timeFrame: after 8 weeks
measure: Change from Baseline in actual Parkinson symptoms
timeFrame: Baseline, after 8 weeks
measure: Global Assessment of tolerability by investigator on a 4-point scale
timeFrame: after 8 weeks
Secondary outcomes:
measure: Number of patients with adverse drug reactions
timeFrame: up to 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02000856: BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension
Official title: BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2013-12-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study is a single center randomised, double-blind, placebo-controlled crossover study to assess the effects of beetroot juice in patients with pulmonary arterial hypertension.


Eligibility criteria: Inclusion Criteria:

* PAH (pulmonary arterial hypertension)
* WHO functional class II-III

Exclusion Criteria:

* WHO functional class I or IV
* pregnancy
* known intolerance or allergy to beetroot
* treatment with Allopurinol
* treatment with Iloprost (inhaled)
* systolic bloodpressure \< 95 mmHg
* diabetes mellitus type 2

Primary outcomes:
measure: Change in VO2 submax and or VO2 max
timeFrame: 7 days
Secondary outcomes:
measure: Change in 6MWT
timeFrame: 7 days
measure: Change in WHO functional class
timeFrame: 7 days
measure: Change in echocardiographic parameters
timeFrame: 7 days
measure: Change in exhaled NO
timeFrame: 7 days
measure: Change in systemic bloodpressure
timeFrame: 7 days
measure: Change in metabolic pathways involved in nitric oxide production and regulation
timeFrame: 7 days
measure: Change in NT-pro-BNP
timeFrame: 7 days
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Uppsala University and Uppsala University Hospital
name: Gerhard Wikström, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04499456: Mediators and Moderators of a Web-based Intervention for Alcohol Use
Official title: Analysis of Mediators and Moderators of a Web-based Intervention for Alcohol Use Among College Students
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Drinking
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2020-08-05
Enrollment: 685
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: Alcohol use among college students causes health and social problems. However, even when available, many students do not access alcohol interventions. Web-based Personalized Normative Feedback (PNF) has been used to disseminate alcohol brief-interventions, and evidence supports PNF efficacy in reducing alcohol consumption among this population. On the other hand, studies on PNF mediators and moderators are scarce, limiting the knowledge on the mechanisms of change and conditions in which their effects occur. Objective: to evaluate whether normative perceptions mediate, and motivation to receive the intervention, moderates the effects of a web-based PNF intervention (Pesquisa Universitária sobre Bebidas - PUB 2.0) for alcohol use among Brazilian college students. Methods: Pragmatic randomized controlled trial among college students aged 18 and over and with follow-up assessments after 1, 3 and 6 months. Participants will be randomized into a Control group (assessment only) or to receive the updated version of the intervention (PUB 2.0). Outcomes are the typical number of drinks (primary outcome) and the total number of drinks consumed, drinking frequency, maximum number of drinks consumed and number of consequences (secondary outcomes). Statistical analyses will consider Structural Equation Models and significance level of 5%. This study will improve knowledge on how and in which conditions a web-based alcohol PNF effects occur, helping tailor future strategies to reduce the impact of alcohol problems among college students.


Eligibility criteria: Inclusion Criteria:

* College student
* Alcohol use during the last year
* Aged 18 or more years

Primary outcomes:
measure: Typical alcohol use
timeFrame: 30 days
measure: Maximum alcohol use
timeFrame: 30 days
Secondary outcomes:
measure: Frequency of alcohol use
timeFrame: 30 days
measure: Total number of drink units
timeFrame: 30 days
measure: Number of consequences
timeFrame: 30 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Departamento de Psicobiologia
Study officials:
References:
Clinical trial NCT00553956: A Randomized Controlled Clinical Trial With Orphans and Widows Who Experienced the Rwandan Genocide
Official title: Phase 1:Epidemiological Study of PTSD and Comorbid Disorders in Widows and Orphans Who Experienced the Rwandan Genocide Phase 2: A Randomized Controlled Clinical Trial With Orphans and Widows Who Experienced the Genocide Carried Out by Trained Local Psychologists -NET/IPT Versus Waiting List-
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Posttraumatic Stress Disorder
Depression
Prolonged Grief Disorder
Lead sponsor: University of Konstanz
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2007-11-06
Enrollment: 150
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In the framework of the epidemiological study, local psychologists are trained in Butare in carrying out diagnostic interviews with orphans and widows who experienced the Rwandan genocide. With the aid of standardized questionnaires they will assess trauma related symptoms as well as Prolonged Grief Disorder. Under the supervision of clinical experts from the University of Konstanz the local psychologists will carry out a randomized house to house survey (Phase 1).

As a second step, a controlled randomized clinical trial will be carried out. Local psychologists will be trained in applying Narrative Exposure Therapy and Interpersonal Psychotherapy. Genocide survivors that will be identified with a PTSD diagnosis will randomly be assigned to either the treatment condition or a waiting list. The treatment group will receive 5 individual sessions of NET in addition to 3 individual IPT sessions. Subsequent 3-months and 6-months post-tests will serve to evaluate the efficacy of this treatment module in alleviating trauma related symptoms and symptoms of prolonged grief. We expect a significant symptom reduction in the experimental group and no significant symptom reduction in the waiting list. After the 6-months post-test, the trained psychologists will train other psychologists in applying this treatment module under the supervision of clinical experts from the University of Konstanz. Afterwards, they will apply therapy to the victims from the waiting list.

A 12-months follow-up will serve to evaluate the long-term effect of the NET/IPT combination.


Eligibility criteria: Inclusion Criteria:

* widows and orphans
* confrontation of the Rwandan genocide
* clinical diagnosis of PTSD

Exclusion Criteria:

* mental retardation
* psychotic symptoms
* current drug or alcohol

Primary outcomes:
measure: Symptoms of PTSD, depression, prolonged grief disorder
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Butare
country: Rwanda
facility: Victims Voice
state: Province de Butare
Study officials:
affiliation: University of Konstanz
name: Susanne Schaal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06531356: Efficiency of Autologous Amniotic Fluid Injection in the Healing of Cesarean Section Scar in High-Risk Population
Official title: Efficiency of Autologous Amniotic Fluid Injection in the Healing of Cesarean Section Scar in High-Risk Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: High Risk Pregnancy
Healing Surgical Wounds
Keywords: amniotic fluid
cesarean section scar (healing)
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 108
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this randomized controlled trial is to investigate the effect of injection of autologous amniotic fluid in the healing of the scar of cesarean section among high-risk population. Investigator's aim is to know : quality of wound healing, rate of infection and time needed for complete healing. Participants will be divided into two groups. All participants will undergo cesarean section. We will inject autologous amniotic fluid in the edges of the wound during skin closure in half of the participants. Wound healing will be assessed at 1st, 2nd and 6th week postoperatively.

Detailed description: After surgery, participants will be observed along 6 weeks (at 1, 2 and 6 weeks intervals) and scars will be assessed regarding color, thickness, pliability and presence of exudate.

Eligibility criteria: Inclusion Criteria:

* Age \> 30 years old.
* Anemic patients
* Maternal chronic disease e.g., Diabetes and Hypertension
* BMI of \> 25 Kg/m2.
* Underwent previous CS.

Exclusion Criteria:

* Rupture of membrane.
* No previous section.
* Anhydraminos.
* Congenital malformation of the fetus.

Primary outcomes:
measure: Quality of wound healing
timeFrame: 1,2,6 weeks postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: kasr Al Aini, Faculty of Medicine, Cairo University
state: Old Cairo
Study officials:
References:
Clinical trial NCT01060956: The Clinical Impact of Isolation of Two Different Bacteria in Urinary Cultures
Official title: The Clinical Impact of Isolation of Two Different Bacteria in Urinary Cultures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infection
Keywords: Urinary tract infection with two bacteria in culture
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2010-02-02
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether identification of two different bacteria in urine culture of patients with indwelling catheter has a clinical impact - change in antibiotic, duration of antibiotic, days to clinical resolution and length of stay in hospital.

The microbiology laboratory will randomized urine cultures with two bacteria from indwelling catheter to either reporting identity and susceptibility of the bacteria or reporting "mixed growth".


Eligibility criteria: Inclusion Criteria:

* Adults hospitalized with indwelling urinary catheter in growth of two bacteria in urine culture

Exclusion Criteria:

* Positive blood cultures or no blood cultures taken

Primary outcomes:
measure: Change of antibiotic treatment
timeFrame: During the episode of urinary tract infection
Secondary outcomes:
measure: Days to clinical resolution
timeFrame: Duration of urinary tract infection and duration of hospitalization
measure: Increase/decrease in the spectrum of antibiotic
timeFrame: Duration of urinary tract infection and duration of hospitalization
measure: Length of stay in hospital
timeFrame: Duration of urinary tract infection and duration of hospitalization
Other outcomes:
Locations:
Study officials:
affiliation: Hebrew university, Jerusalem, Israel
name: Amos M Yinnon, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05044156: Investigation of the Relationship Between Salivary Histatine-5 Level and Vaginal Candidiasis in Women
Official title: Investigation of the Relationship Between Salivary Histatine-5 Level and Vaginal Candidiasis in Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginal Infection
Candidiasis
Lead sponsor: Usak State Hospital
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women with regularly menstrual cycle, diagnosed candidal vaginosis and not have any vaginal infection.

Brief summary: The low Histatine-5 (HST-5) level of the saliva can lead to vaginal candidiasis. Because HST-5 level in the saliva can effect vaginal Ph, flora and local defence mechanisms.

Histatine-5 is secreted in the parotis and submandibular glands. İt riches histidine amino ascid and have antifungal activity. Salivary proteins and their plasma levels were found as similar in the literature.

Detailed description: Women with regularly menstrual cycle will enroll in the study than will separate two groups:

Study group: women with vaginal candidiasis ( diagnosed by clinic and lab.)

Control group: women ( not have any vaginal infections candida and others)

Saliva samples will be taken from two groups than HST-5 level will be analyzed. Finally HST-5 levels of the two groups will be compared .

Women with diabetes, immun deficiency, pregnancy, virgin, menopausal period , premature ovarian failure will be excluded.

Eligibility criteria: Inclusion Criteria: women with regularly menstrual cycle , diagnosed candidal vaginosis and not have any vaginal infection.

-

Exclusion Criteria: diabetes, immun deficiency, menopause, premature ovarian failure, pregnancy, virgin

-

Primary outcomes:
measure: SALIVARY HISTATINE-5 LEVEL IN THE WOMEN WITH VAGINAL CANDIDIASIS
timeFrame: 1 month
Secondary outcomes:
measure: SALIVARY HISTATINE-5 LEVEL IN THE WOMEN WITH VAGINAL CANDIDIASIS
timeFrame: 2 month
Other outcomes:
Locations:
city: Usak
country: Turkey
facility: İrem Şenyuva
Study officials:
affiliation: USAK TRAINING AND RESEARCH HOSPITAL
name: İREM ŞENYUVA, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khurshid Z, Najeeb S, Mali M, Moin SF, Raza SQ, Zohaib S, Sefat F, Zafar MS. Histatin peptides: Pharmacological functions and their applications in dentistry. Saudi Pharm J. 2017 Jan;25(1):25-31. doi: 10.1016/j.jsps.2016.04.027. Epub 2016 May 4.
citation: Loo JA, Yan W, Ramachandran P, Wong DT. Comparative human salivary and plasma proteomes. J Dent Res. 2010 Oct;89(10):1016-23. doi: 10.1177/0022034510380414. Epub 2010 Aug 25.
citation: Liao H, Liu S, Wang H, Su H, Liu Z. Efficacy of Histatin5 in a murine model of vulvovaginal candidiasis caused by Candida albicans. Pathog Dis. 2017 Aug 31;75(6). doi: 10.1093/femspd/ftx072.