louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04492150: Effect of Glucose 5% on Labor Length
Official title: The Effect of Adding Parenteral Dextrose Solution During Induction of Labor on Total Labor Length Among Multiparous Women in Ismailia, Egypt: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Induction of Labor Affected Fetus / Newborn
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 476
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Induction of labor, is one of the most common obstetric procedures done routinely in modern obstetrics. For example, in USA, 23% of pregnant women in 2012 (about 1 million) underwent an induction of labor. However, accurate data about percentage of women undergoing induction of labor in Egypt is not accurately known.

One of the recent research era in current obstetrics is the optimal intravenous (IV) hydration of the pregnant women in labor.Current evidences available in our hands, suggest that maternal hydration appears to fasten labor progress and enhance the action of oxytocin, if the later is used for augmentation. However, the addition of glucose supplementation to this IV hydration to enhance uterine contraction, as a matter of safety and efficacy, is controversial


Eligibility criteria: Inclusion Criteria:

* Adult (\>18 years) multiparous women
* Late Term Pregnancy ( gestational Age Between 40-42 weeks)
* Uncomplicated singleton pregnancy with cephalic presentation.
* Favorable cervix for induction (Bishop score\<6) without ruptured membranes.

Exclusion Criteria:

* Women with chronic diseases or complicated pregnancy; gestational and pre gestational ( type 1 \& 2)diabetes, preeclampsia and\\or renal and\\or maternal heart diseases.
* Non-cephalic presentations, multiple pregnancies, or cervix unfavorable for induction.
* Other indications for cesarean delivery

Primary outcomes:
measure: the duration of labor
timeFrame: 24 hours
Secondary outcomes:
measure: Rate of cesarean sections
timeFrame: 24 hours
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Suez canal University
Study officials:
affiliation: Professor of Gynecology and Obstetrics
name: Zakia M Ibraheim, MD
role: STUDY_CHAIR
affiliation: Assistant Professor of Gynecology and Obstetrics
name: Mariam L Mohammed, MD
role: STUDY_DIRECTOR
affiliation: Assistant Professor of Gynecology and Obstetrics
name: Hanan M Ghoneim, MD
role: STUDY_DIRECTOR
affiliation: Assistant Professor of Gynecology and Obstetrics
name: Ahmed M Abbas, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01794650: Guidelines for Post-exercise Dietary Intake in T1DM
Official title: The Metabolic and Glycaemic Responses to Changes in the Glycaemic Index of the Meal Consumed After Performing Evening Exercise in Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: T1DM, Exercise, Hypoglycaemia
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2013-02-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators hypothesise that manipulating the glycaemic index of the meal after exercise and before sleep will help prevent Type 1 diabetes individuals experiencing hypoglycaemia.


Eligibility criteria: Inclusion Criteria:

* Aged between 18-50 years old (male or female).
* Free from any diabetes related complications (apart from mild background diabetic retinopathy).
* HbA1c \<8.5%.
* Not taking any prescribed medication other than insulin, and treated with a stable insulin regimen composed of a combination of slow/long acting insulin (glargine or detemir) and fast-acting insulin analogues (lispro or aspart), for a minimum of 6 months before the start of the study.
* Demonstrate normal cardiac function in response to exercise.

Exclusion Criteria:

* Aged younger than 18, or older than 50 years.
* Suffering from, or diagnosed with a diabetes related complication (apart from mild background diabetic retinopathy).
* HbA1c \>8.5%.
* Currently taking prescribed medication, and not currently treated with a stable basal bolus regimen composed of a combination glargine or determir, and lispro or aspart for at least 6 months before the start of the study.
* Failure to demonstrate normal cardiopulmonary responses during exercise, or have a medical condition which could prevent completion of exercise or be exacerbated because of.

Primary outcomes:
measure: 24 hour blood glucose area under the curve
timeFrame: 24 hours
Secondary outcomes:
measure: Ketogenesis
timeFrame: 60 minutes before and 24 hours post-exercise
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Clinical Research Facility, Royal Victoria Infirmary
state: Tyne and Wear
Study officials:
affiliation: Northumbria University
name: Daniel J West, PhD, BSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06986850: FeelSync: Tailoring Ecological Momentary Assessments and Interventions for Emotion Awareness, Regulation, and Mental Health Outcomes
Official title: FeelSync: Tailoring Ecological Momentary Assessments and Interventions for Emotion Awareness, Regulation, and Mental Health Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress
Keywords: ecological momentary assessment
ecological momentary intervention
language
cognitive reappraisal
emotion regulation
emotion awareness
mental health
Lead sponsor: Erasmus University Rotterdam
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This study investigates how different ways of reflecting on emotions in daily life influence emotional awareness, emotion regulation, and mental health. Using the FeelSync mobile app over the course of seven days, participants are prompted multiple times a day to report on their current emotional state in various formats (e.g., rating scales, multiple choice, or free text). In some groups, participants also receive brief daily exercises designed to help them practice cognitive reappraisal-a strategy that involves reframing stressful situations to reduce their emotional impact. The study aims to assess not only the overall effectiveness of these reappraisal exercises but also whether the type of emotional self-report used before the intervention affects its impact. All participants complete questionnaires before and after the app phase to track changes in mood, stress, emotional awareness, and regulation.


Eligibility criteria: Inclusion Criteria:

* Owning a smartphone
* Proficiency in English language
* Being a student
* Age between 18 to 30 years old

Exclusion Criteria:

- Severe mental health disorder

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: Baseline (pre-intervention, study day 1) and Follow-up (post intervention, study day 9)
measure: Beck Depression Inventory II
timeFrame: Baseline (pre-intervention, study day 1) and Follow-up (post intervention, study day 9)
measure: State-Trait Anxiety Inventory
timeFrame: Baseline (pre-intervention, study day 1) and Follow-up (post intervention, study day 9)
measure: Emotion Regulation Questionnaire
timeFrame: Baseline (pre-intervention, study day 1) and Follow-up (post intervention, study day 9)
measure: Cognitive Emotion Regulation Questionnaire
timeFrame: Baseline (pre-intervention, study day 1) and Follow-up (post intervention, study day 9)
measure: Toronto Alexithymia Scale
timeFrame: Baseline (pre-intervention, study day 1) and Follow-up (post intervention, study day 9)
Secondary outcomes:
measure: Mobile Agnew Relationship Measure
timeFrame: Follow-up (post intervention, study day 9)
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus University Rotterdam
Study officials:
References:
Clinical trial NCT03089450: To Evaluate Safety and Efficacy of CGBIO Stent Compared to Biomatrix Flex Stent
Official title: A Multicenter, Subject-blinded, Randomized Study to Evaluate Safety and Efficacy of CGBIO Stent Compared to Biomatrix Flex Stent in Patients Undergoing Drug-eluting Stent Procedure After Coronary Angiography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Heart Disease
Stable Coronary Artery Disease
Stable Angina
Unstable Angina
NSTEMI - Non-ST Segment Elevation MI
Lead sponsor: CGBio Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-24
Enrollment: 112
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to evaluate safety and efficacy of CGBIO stent(DES) compared to Biomatrix flex stent(DES)

Detailed description: A Multicenter, subject-blinded, randomized study to evaluate safety and efficacy of CGBIO stent compared to Biomatrix Flex stent in patients undergoing drug-eluting stent procedure after coronary angiography

Eligibility criteria: Inclusion Criteria:

* At least one lesion with a diameter stenosis \>50%
* suitable for coronary stent implantation in a vessel with a reference diameter ranging from 2.5 mm to 4.0 mm;
* Gr 1 ≤TIMI flow

Exclusion Criteria:

* ST-segment elevation MI
* Bifurcation lesion
* Chronic total occulusion
* Restenosis lesion
* Graft vessel lesion
* Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated or in which patient will not be able to comply with dual antiplatelet therapy for at least 1 year
* Cardiogenic shock or hemodynamic compromise
* Existing impairment in liver and kidney.

Primary outcomes:
measure: in-segment late loss
timeFrame: 9 month
Secondary outcomes:
measure: in-stent late loss
timeFrame: 9 month
measure: MACE
timeFrame: 9 month
measure: Restenosis rate
timeFrame: 9month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Soeul National University Hospital
Study officials:
affiliation: Soeoul national university hospital
name: Hyo-Soo KIim, MD/PhD
role: STUDY_CHAIR
affiliation: Hanyang University
name: Young-Hyo Lim, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wonju Severance Christian Hospital
name: Junghan Yoon, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02791750: 5 Years Follow-up With Adjuvant Therapy for Women With Breast Invasive Carcinoma
Official title: 5 Years Follow-up in the Lorraine Institute of Oncology With Adjuvant Therapy for Women With Breast Invasive Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: hormone replacement therapy
breast cancer
follow up
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2016-06-07
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients following-up in the Lorraine Institute of Oncology at 5 years of the beginning of an adjuvant hormonal therapy

Brief summary: Non-persistence to adjuvant hormonal therapy for breast cancer at 5 years decrease its efficacy. The objective of this study is to know the women experience (persistence, treatment changes, quality of life) and its determinants, in a french population.


Eligibility criteria: Inclusion Criteria:

* Patients following-up in the Lorraine Institute of Oncology at 5 years of the beginning of an adjuvant hormonal therapy
* Women with breast invasive carcinoma positive-RH and indication of adjuvant hormonal therapy
* Adult patients
* Being capable and agree to follow the study procedure
* Patients informed and non-opposed
* Covered by social security

Exclusion Criteria:

* History of other cancer except basal cell carcinoma
* Patients with breast invasive carcinoma negative-RH
* Synchronous metastases
* Relapsed
* Previous adjuvant hormonal therapy
* Men
* Patients with guardianship

Primary outcomes:
measure: Factors associated with persistence to hormone therapy for breast cancer
timeFrame: 1 day
Secondary outcomes:
measure: Comparison of the quality of life
timeFrame: 1 day
measure: Proportion of women with a change in their treatment
timeFrame: 1 day
measure: Cause of treatment discontinuation
timeFrame: 1 day
measure: Continued homonotherapy
timeFrame: 1 day
Other outcomes:
Locations:
city: Vandoeuvre lès Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: LESUR ANNE, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07001150: Role of Silymarin in Neuroprotection and Symptom Management in Parkinson's Disease
Official title: Clinical Study Evaluating the Possible Role of Silymarin in Neuroprotection and Symptom Management in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Parkinson Disease
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Prof. Sahar Kamal Hegazy,Head of Clinical Pharmacy Department,Faculty of Pharmacy,Tanta University
name: Dr. Raed Ahmed Abdel-Maboud,Lecturer of neurology,Faculty of Medicine,Tanta University
First posted: 2025-06-03
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Parkinson's disease (PD) is a leading neurodegenerative movement disorder, marked by a gradual loss of dopamine-producing neurons in the substantia nigra pars compacta (SNpc) and the accumulation of α-synuclein protein aggregates. Silymarin, a polyphenolic flavonoid renowned for its potent antioxidant properties, will be studied for its neuroprotective effects in PD.


Eligibility criteria: Inclusion Criteria:

* Age between 45 and 65 years old
* Both sexes
* Patients with Parkinson's disease on dopamine replacement therapy
* Modified Hoehn and Yahr stage, MHY 1-4 (29)

Exclusion Criteria:

* Subjects \< 18 years of age
* Pregnant or breastfeeding women
* Suspected hypersensitivity to silymarin or multivitamins
* Advanced liver disease (e.g., ascites, bleeding esophageal varices, and hepatic encephalopathy)
* Subjects with morbid obesity, i.e., a Body Mass Index (BMI) \> 40
* Subjects with severe illness, e.g., multisystem failure, cancer, or poorly controlled diabetes, i.e., known diabetic with Hemoglobin A1C (HbA1C)\>7%
* Current use of Silymarin or recent use within the past two weeks.
* Other conditions, which, in the opinion of the investigators, make the patient unsuitable for enrollment.

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04687150: Fecal Microbiota Transplantation and Newly Diagnosed Ulcerative Colitis (UC)
Official title: Fecal Microbiota Transplantation in Newly Diagnosed Ulcerative Colitis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Helsinki University Central Hospital
name: Päijänne Tavastia Central Hospital
First posted: 2020-12-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized placebo-controlled pilot study. Accrued participants were randomized 1:1 using a computer generated randomization algorithm (www.random.org).
Primary purpose: TREATMENT

Brief summary: In this FinUC study we are trying to find out the efficacy and safety of the Fecal microbiota transplantation (FMT) in newly diagnosed active ulcerative colitis patients. The study group with newly diagnosed active ulcerative colitis receive an FMT via colonoscopy from a tested general donor, frozen and thawed from a fecal bank at week 0 and at week 4 as an enema at the study nurse´s visit. The control group will be given colored water. The main aim of the FinUC study is to determine how the FMT change of the gut microbiota composition in newly diagnosed active ulcerative colitis patients. The other aim is to determine efficacy and mechanisms of fecal microbiota transplantation.


Eligibility criteria: Inclusion Criteria:

* Over 18 years
* Active newly diagnosed colitis (Mayo score \<11)
* Signed informed consent

Exclusion Criteria:

* Fulminant severe colitis (Mayo score 11-12 or Truelove and Witts criteria)
* Gastrointestinal infection
* Pregnancy
* Antibiotic therapy at the baseline
* On-going probiotic medication
* Unable to provide signed informed consent

Primary outcomes:
measure: Modified gut microbiota composition
timeFrame: at week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Kimmo Salminen
Study officials:
affiliation: Head of the section
name: Kimmo K Salminen, MD,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05746650: Improving Tissue Repair After Injury in the Muscle-tendon Interface Muscle Tissue Injury
Official title: Regulation of Protein Turnover in Connective Tissue From Muscle and Tendon Following Muscle Tissue Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Muscle Injury
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study is a 2-week human study where 40 patients who are scheduled to undergo reconstructive knee surgery are randomized to administration of GH or placebo following or without neuromuscular electrical stimulation of hamstring muscles.The overall aim is to determine, the role of muscle connective tissue protein synthesis in muscle injury and repair.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women scheduled to undergo reconstructive knee surgery
* BMI 18-35

Exclusion Criteria:

* Former or current use of growth hormone or anabolic steroids
* Use of corticosteroids in the past 3 months
* Use of any medication known to affect muscle or tendon turnover
* Former participation in a study using deuterated water
* Chronic diseases

Primary outcomes:
measure: Difference in muscle and myotendinous junction protein synthesis in regenerating vs. control muscle
timeFrame: 2 years
Secondary outcomes:
measure: Difference in muscle protein synthesis in regenerating muscle, myotendinous junction tissue with or without growth hormone
timeFrame: 2 years
measure: Single protein synthesis in regenerating vs. control muscle and myotendinous junction tissue
timeFrame: 2 years
measure: Single protein synthesis in regenerating muscle and myotendinous junction tissue with or without growth hormone
timeFrame: 2 years
measure: Tendon tissue synthesis from injured muscle vs. control muscle
timeFrame: 2 years
measure: Difference in muscle protein synthesis in regenerating muscle, myotendinous junction, and tendon tissue with or without growth hormone
timeFrame: 2 years
measure: Difference in muscle protein synthesis in regenerating vs. control muscle, myotendinous junction, and tendon tissue
timeFrame: 2 years
measure: Number of satellite cells, fibroblasts and immune cells in renereting vs. control tissue, with and without growth hormone
timeFrame: 2 years
measure: Mechanical properties of tissue with and without growth hormone
timeFrame: 2 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Institute of Sports Medicine, Bispebjerg Hospital
name: Grith Højfeldt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04234750: Mesenchymal Stem Cell-derived Pleiotropic Factor in the Treatment of Donor Sites
Official title: The Evaluation of the Safety and Effectiveness of Mesenchymal Stem Cell-derived Pleiotropic Factor in the Treatment of Donor Sites
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Evaluate the Safety and Effectiveness of Mesenchymal Stem Cell Conditioned Medium-derived Pleiotropic Factor in Treating Donor Sites
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-01-21
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Skin grafting is a standard treatment for deep wounds, but care of the donor site after transplantation is very important. The means of accelerating wound healing can increase overall patient satisfaction. In recent years, cytokine therapy has been an important strategy to promote tissue repair.Mesenchymal stem cells (MSC) have been considered the star cells that promote tissue repair. It works mainly through paracrine. Many biological effectors, including IGF-1, vascular endothelial growth factor (VEGF), TGF-β1, and hepatocyte growth factor (HGF), have been found and reported in various MSC conditioned media (MSC-CM), And play a role in promoting tissue repair and regeneration. In here, we aim to explore the MSC-CM-derived pleiotropic factor in treating donor sites and further evaluate its safety and effectiveness


Eligibility criteria: Inclusion Criteria:

Mainly mild to moderate burns, III ° burn area is less than 20% (trauma factor is thermal burn); Thick-thickness skin (thickness 0.2-0.3mm), donor area and medium-thickness skin (thick 0.3-0.5mm) for the skin area study separately; Psychologically stable and able to complete the test process-

Exclusion Criteria:

History of clotting disorders, uncontrolled diabetes; Drug abuse, excessive drinking, malignant or autoimmune diseases, chemotherapy and immunosuppressive therapy; Significant local infection or combined systemic infection; Patients with severe heart, lung, liver, kidney, blood system and mental and nervous system diseases; Women during pregnancy and lactation-

Primary outcomes:
measure: wound healing rate
timeFrame: 1 month
Secondary outcomes:
measure: Vancouver score
timeFrame: 6 months
Other outcomes:
Locations:
city: Datong
country: China
facility: People's Liberation Army Central Air Force Hospital
state: Shanxi
Study officials:
affiliation: Chinese PLA General Hospital
name: Xiaobing Fu, doctor
role: PRINCIPAL_INVESTIGATOR
References: