louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05213559: Metabolic Responses After 12-week Hypocaloric Diet Supplemented With a Cereal-based Plant Protein Biscuit
Official title: Glucose and Gastrointestinal Hormone Responses of Subjects With Overweight/Obesity After 12-week Hypocaloric Dietary Intervention Supplemented With a Cereal-based Biscuit Enriched With Plant Proteins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetite
Keywords: cereal-based biscuit enriched with plant proteins
appetite regulation
glycemic control
hormone responses
Lead sponsor: Harokopio University
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
First posted: 2022-01-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Biscuits enjoy high popularity in the human diet and can be excellent snack alternatives and potential carriers of ingredients with appetite regulating properties. In the present study, the effects of a wheat biscuit enriched with plant proteins originated from legumes and seeds on gastrointestinal hormone responses of women with overweight/obesity after a hypocaloric dietary intervention will be examined.

Detailed description: Women with overweight/obesity will follow a 12-week dietary intervention supplemented with a cereal-based biscuit enriched with plant proteins or a common isocaloric wheat biscuit as a daily snack.

At the beginning and at the end of the dietary intervention postprandial metabolic responses, body weight reduction and subjective appetite ratings will be examined.

Eligibility criteria: Inclusion Criteria:

* non-diabetic women with overweight/obesity
* constant body weight for the last three months before enrollment
* standard dietary and physical activity habits

Exclusion Criteria:

* pregnancy
* lactation
* chronic medical illness
* use of nutritional supplements
* alcohol consumption \>2 drinks per day

Primary outcomes:
measure: change in postprandial glucose response
timeFrame: Time points: 0,30,60,91,120,180 min postprandially at week 0 and week 12.
Secondary outcomes:
measure: change in postprandial appetite regulating hormone responses
timeFrame: Time points: 0,30,60,91,120,180 min postprandially at week 0 and week 12.
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens
state: Attiki
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Alexander Kokkinos, Professor
role: STUDY_CHAIR
affiliation: Harokopio University
name: Amalia Yanni, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02115659: Triptolide-Containing Formulation as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Official title: Randomized Controlled Trial of Triptolide-Containing Formulation for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Keywords: ADPKD
triptolide
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2014-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Triptolide was shown in experimental studies to inhibit the cyst formation and growth in ADPKD models, while triptolide-containing formulation was revealed to potentially slow the disease progression in several proteinuric ADPKD patients in our clinical practice. It remains to be shown the effect of triptolide-containing formulation on total kidney volume (TKV) enlargement and renal function protection in ADPKD patients.

Detailed description: Randomized Controlled Trial

Eligibility criteria: Inclusion Criteria:

* ADPKD patient older then 40 years of age without gender limitation
* Estimated glomerular filtration rate (eGFR) higher than 60 ml/min 1.73m2
* documented kidney volume progression with yearly increasing rate more than 6%
* informed consent

Exclusion Criteria:

* Female who is planning to become pregnant, who is pregnant and/or lactating, who is unwilling to use effective means of contraception
* impaired liver function as increased liver enzymes (2-fold above normal values)
* uncontrolled hypercholesterolemia (fasting cholesterol \> 8 mmol/l) or hypertriglyceridaemia (\> 5 mmol/l) under lipid lowering therapy
* granulocytopenia (white blood cell \< 3,000/mm3) or thrombocytopenia (platelets \< 100,000/mm3)
* hepatitis B or C, HIV infection
* malignancy
* mental illness that interfere with the patient ability to comply with the protocol
* drug or alcohol abuse
* known hypersensitivity to similar drugs as Triptolide-Containing Formulation

Primary outcomes:
measure: renal volume measured by high resolution magnetic resolution imaging
timeFrame: 2 yrs
Secondary outcomes:
measure: Estimated glomerular filtration rate (eGFR)
timeFrame: 2 yrs
measure: Adverse events.
timeFrame: 2 yrs
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Changzheng Hospital
name: Changlin Mei, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04867759: Uterine Natural Killer (uNK) Cell Expression in Patients With Repeated ICSI Failures: A Multicenter Cohort Study
Official title: Uterine Natural Killer (uNK) Cell Expression in Patients With Repeated ICSI Failures: A Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Repeated Implantation Failure
ICSI Failure
uNatural Killer Cells
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Mansoura University
name: Benha University
First posted: 2021-04-30
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with repeated implantation faikure

Brief summary: uterine NK (uNK) cells are characterized by a high expression of CD56 (CD56brihgt), lack of CD16 expression, high secretion of cytokines and rather low cytotoxic activity. It has been shown that uNK cells increase in number during the late secretory phase and during early pregnancy. This study was designed to assess the possible role of uNK cells in repeated ICSI failure.

Detailed description: For occurrence of the "window of implantation", the endometrium must proliferate, increase in thickness, then, after ovulation, adequately respond to progesterone, and become receptive. Ultrasound examination of the thickness and appearance of the endometrium is an easily performed means of assessing morphological changes occurring in the endometrium during the follicular phase, and is thus used as a measure to predict successful implantation. Indeed, several studies have reported a strong association between endometrial thickness and successful implantation. However, others failed to confirm such an association. The minimal adequate endometrial thickness for successful implantation, as measured in the late proliferative phase, varies between studies, with a range of 6-8 mm. However, although rare, some investigators have reported successful implantation in an endometrium of no more than 5 mm thickness.

Uterine NK cell testing can only be done via an endometrial biopsy. Uterine natural killer cells never come into direct contact with the fetal cells-they only have direct access to placental cells.The biopsy is performed on day 21 of your menstrual cycle, when the NK cell count is at its highest. The procedure is done at outpatient clinics and results take about two weeks to receive. If your NK cell activity reading is greater than 14 % on day 21 biopsy, then diagnosed with high levels of NK cell activity.

Eligibility criteria: Inclusion Criteria:

* Patients with IVF/ICSI failures more than 2 times
* Age 20-40 years

Exclusion Criteria:

* prior uterine surgery
* immunological disease
* previous testing to uNK cells

Primary outcomes:
measure: Level of uNK cells
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Adel Elgergawy
Study officials:
References:
Clinical trial NCT01507259: Chocolate's Effect on the Cerebral Vasculature
Official title: A Randomised Trial of Effect of Chocolate Upon Cerebrovascular Reactivity in Healthy Adult Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Vasculature
Keywords: Determine effect on cerebral vasculature
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2012-01-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy controls

Brief summary: The popularity of chocolate can largely be attributed to its mood elevating properties, research shows that it contains antioxidants that also provide physical health benefits. Dark chocolate, in particular, contains high levels of an antioxidant called epicatechin, which is known to cause changes in blood vessels by relaxing them and increasing blood flow.

Little is know about the immediate effects of chocolate consumption, or the differences between milk and dark chocolate with regards to these effects. The project will investigate the effect of a single bar of dark or milk chocolate upon blood flow to the brain, using simple ultrasound tests.


Eligibility criteria: Inclusion Criteria:

* No regular medication including vitamins/antioxidants
* Able to provide informed consent

Exclusion Criteria:

* Inability to perform breath-hold test
* Any known cardiovascular disease, diabetes, throid disease, high blood pressure, hyperlipidaemia or pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Western Infirmary
Study officials:
References:
Clinical trial NCT03578159: Study of Arsha Vidya Chhatralaya Initiative on Health and Functioning of Disadvantaged Tribal Children
Official title: Study of Arsha Vidya Chhatralaya Initiative on Health and Functioning of Disadvantaged Tribal Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Disorder
Mental Health Wellness
Social Function Disorder, Childhood or Adolescent
Malnutrition
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Warwick Research Services
name: Arsha Vidya Tirtha
First posted: 2018-07-06
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children selected from Udaipur tribal areas, Rajasthan, India

Brief summary: India's poor tribal communities have far worse health and social indicators than the general population. Most tribal people live in remote forested or desert areas where illiteracy, trying physical environments, malnutrition, inadequate access to potable water, and lack of personal hygiene and sanitation make them more vulnerable to disease.The aim of Chhatralaya initiatives taken by Arsha Vidya, Jaipur was to address the exclusion of the socially and economically disadvantaged children of the tribes and to provide a fair opportunity to all.


Eligibility criteria: Inclusion Criteria:

* Children selected from Udaipur tribal areas as lacking parental care and basic services;
* Children living in Udaipur tribal areas;
* Children from 8 years to 16 years of age

Exclusion Criteria:

Primary outcomes:
measure: Physical health and wellbeing
timeFrame: Change from baseline to one year
measure: Mental Health and wellbeing
timeFrame: Change from baseline to one year
measure: Social functioning
timeFrame: Change from baseline to one year
measure: Academic functioning
timeFrame: Change from baseline to one year
Secondary outcomes:
measure: Weight
timeFrame: Change from baseline to one year
measure: Prevalence of acute child malnutrition
timeFrame: Change from baseline to one year
Other outcomes:
Locations:
city: Jaipur
country: India
facility: Arsha Vidya Chhatralaya,
state: Rajasthan
Study officials:
affiliation: Arsha Vidya Tirtha
name: Brahmaparananda Saraswati
role: STUDY_CHAIR
affiliation: Warwick Research Servives, UK
name: Neha Sharma, PhD
role: STUDY_DIRECTOR
affiliation: NMP Medical Research Institute
name: Puneet Sharma
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02373059: Shared Decision Making With Pharmaceutical Care
Official title: Examining the Use of a Shared Decision Making Tool With Pharmaceutical Care in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A research study to enhance clinical discussion between patients and pharmacists using a shared decision making tool for type 2 diabetes or usual care.


Eligibility criteria: Inclusion Criteria:

* Adults ≥ 18 years of age
* Diagnosed with type II diabetes by ICD-9 code for more than one year
* HbA1c of 7%-9.5% within past 6 months
* Prescribed three or less anti-hyperglycemic medications as indicated by the medication list within the medical record

Exclusion Criteria:

* Prescribed insulin
* Pregnancy
* Appointment with provider within a month
* Appointment with provider within the last month
* Followed by endocrinology

Primary outcomes:
measure: Patient Involvement Questionnaire
timeFrame: Post-Visit up to 2 weeks
Secondary outcomes:
measure: Patient Knowledge regarding Diabetes treatments Questionnaire
timeFrame: post visit up to 2 weeks
measure: Patient Medication Adherence Questionnaire
timeFrame: 1 month post visit
Other outcomes:
Locations:
city: Kasson
country: United States
facility: Mayo Clinic Kasson
state: Minnesota
Study officials:
References:
Clinical trial NCT05015959: Analysis of Surgical Mortalities Using the Fishbone Model for Quality Improvement
Official title: Analysis of Surgical Mortalities Using the Fishbone Model for Quality Improvement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Surgical and Medical Care, Unspecified
Lead sponsor: University of Witwatersrand, South Africa
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 859
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all adults 18 years or older that presented to our institution and died withing the study period.

Brief summary: Retrospective data analysis of mortalities and the evaluation of the quality of care offered, using the Fishbone method.

Detailed description: Evaluation of mortalities seen between 01 January 2017 and 31 December 2018. Analysis of the mortality decision into preventable, non-preventable and potentially preventable categories. Identifying the associated risk factors and co-morbidities in a single centre study in Johannesburg. Further analysing was performed on the subset of preventable mortalities and further do the fishbone model of quality of care. RedCap data was utilized for all data points. A further comparison was done to the MNM classification based on the team and an independent senior surgeon.

Eligibility criteria: Inclusion Criteria: All mortality of patients seen in the Department who were 18yrs or older

-

Exclusion Criteria:

* incomplete data death in the Emergency department

Primary outcomes:
measure: mortality outcomes
timeFrame: study period (Jan 2017 to Dec 2018)
Secondary outcomes:
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Charlotte Maxeke Johannesburg Academic Hospital
state: Gauteng
Study officials:
affiliation: University of Witwatersrand, South Africa
name: Maeyane Moeng, MBBCH, FCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05019859: Effects of a Low Carb Diet on Erectile Function and Serem Testosterone in Men With Metabolic Syndrome
Official title: Effects of a Low Carb Diet on Erectile Function and Serem Testosterone in Men With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Testosterone Deficiency
Metabolic Syndrome
Diet Modification
Keywords: low carb diet
hypogonadism
metabolic syndrome
Lead sponsor: Hospital Moinhos de Vento
Sponsor class: OTHER
Collaborators: name: Hospital de Clinicas de Porto Alegre
First posted: 2021-08-25
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: Investigate if low carb diet could increase serum testosterone level in hypogonadic men

Detailed description: Randomized controlled trial to evaluate the effect of low carb diet in men with metabolic syndrome and low testosterone level. The inclusion criteria is men with metabolic syndrome and serum total testosterone below 300 ng/dL. They will randomized to perform a low carb diet or a traditional low fat diet for metabolic syndrome. The follow up will be of three months with a once a month visit. Even though these men will be looked at their sexuality and life style. They will be monitoring by urologists and nutritionists during the study.

Eligibility criteria: Inclusion Criteria:

* metabolic syndrome, serum testosterone level below 300 ng/dL

Exclusion Criteria:

* active cancer, diet allergies, psychological incapability

Primary outcomes:
measure: testosterone
timeFrame: three months
Secondary outcomes:
measure: IIEF 5
timeFrame: three months
measure: AMS
timeFrame: three months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas Porto Alegre
state: RS
Study officials:
affiliation: Hospital de Clínicas Porto Alegre
name: Brasil S Neto, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital Moinhos de Vento and Hospital de Clínicas Porto Alegre
name: Caio S Schmitt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03810859: Non-syndromic Inherited Anomalies of Mineralized Tooth Tissues: a Whole Exome Study to Identify New Pathogenic Variants
Official title: Non-syndromic Inherited Anomalies of Mineralized Tooth Tissues: a Whole Exome Study to Identify New Pathogenic Variants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amelogenesis Imperfecta
Dentinogenesis Imperfecta
Dentin Anomalies
Keywords: Amelogenesis imperfecta
Dentinogenesis imperfecta
Dentin anomalies
Whole Exome Study
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: French rare diseases Healthcare Network
name: The French Foundation for Rare Diseases
First posted: 2019-01-22
Enrollment: 14
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: ExoDent specifically aims to discover new genes and new mutations causing isolated amelogenesis imperfecta (AI) and dentinogenesis imperfecta (DI) and other dentin anomalies. The key point for clinicians is to distinguish between non syndromic and syndromic disorders in order to improve patients guidance and counseling. To do so, two targeted NGS panel have been designed, one searching for isolated AI and the other for DI. After 18 months, some families remain without any positive results. ExoDent project proposes those negative patients a Whole Exome Sequencing (WES) approach to deeper explore their genetic background.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of amelogenesis imperfecta or dentinogenesis imerfecta or other dentin anomaly with no other signs or symptoms ( familial or isolated)
* negative results after targeted NGS strategy for molecular diagnosis

Exclusion Criteria:

* absence of positive clinical diagnosis
* Diagnosis of syndromic disease

Primary outcomes:
measure: Genome sequencing
timeFrame: After one day
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hospital Cochin
Study officials:
affiliation: APHP
name: Céline GAUCHER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06696859: Patterns of Antibiotics Resistance
Official title: Patterns of Antibiotics Resistance Among Respiratory ICU Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Antibiotics Resistance
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All patients will be admitted at respiratory ICU with respiratory infection who have been treated with antibiotics and patients in whom adequate respiratory specimen

Brief summary: Antibiotics resistance has become a global health challenge especially in third world countries. The main causes of antibiotics resistance are the improper use or overuse of antibiotics, the lack of skilled public health workers and poor hygiene standards. Resistance to antibiotics reduces the effectiveness of these treatments and has a negative impact on hospital systems especially in intensive care settings.

Medical intensive care unit (MICU) is commonly known as a "hotbed of infections" in high-risk healthcare environments ICU patients are especially prone to infections because of the various invasive procedures they undergo,including vascular access, mechanical ventilation, and intubation.


Eligibility criteria: Inclusion Criteria:

* All patients will be admitted at respiratory ICU with respiratory infection who have been treated with antibiotics and patients in whom adequate respiratory specimen is obtained will be included in the study

Exclusion Criteria:

* Patients who are HIV positive, who can't provide adequate respiratory specimen, patients who are not on antibiotics and patients who die within 48 hours after admission

Primary outcomes:
measure: Patterns of Antibiotics Resistance
timeFrame: 6months to 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: