louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02599740: Natural Fruit Extract Versus the Assumed Key Active Compound in Reducing the Post-prandial Blood Glucose Level
Official title: The Bioequivalence of a Natural Extract Versus the Assumed Key Active Compound in Reducing the Post-prandial Blood Glucose Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Blood glucose
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
First posted: 2015-11-09
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to test bioequivalence of a assumed key active compound vs. natural fruit extract as judged from the Incremental area under the curve (+iAUC0-2h) for blood glucose: i.e. the 90% confidence interval of the ratio +iAUC0-2h for blood glucose for assumed key active compound vs. natural extract falls between 0.8 - 1.25.

Detailed description: The basic study design for this Williams design consists of six distinct treatment sequences; within each of the treatment sequences the treatments are duplicated.

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) ≥ 18.5 and ≤ 25.0 kg/m2.
* Apparently healthy males and females: no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery \[with exception of cholecystectomy and appendectomy\] and inflammatory diseases).
* Fasting blood glucose value of subjects is ≥ 3.4 and \<6.1 mmol/litre (i.e. 62- 110 mg/dl) at screening.

Exclusion Criteria:

* Use of antibiotics within 3 months before day 1; use of any other medication within 14 days before day 1 except for both paracetamol and hormonal contraception.

Primary outcomes:
measure: Change of 2-h Post Prandial Blood Glucose (PPG) based on response to different treatments
timeFrame: 0-2 hours
Secondary outcomes:
measure: Change of 3-h PPG based on response to different treatments
timeFrame: 0-3 hours
measure: Change of 2-h and 3-h post-prandial insulin based on response to different treatments
timeFrame: 0-2 hours and 0-3 hours
measure: Max plasma concentration for assumed key active
timeFrame: 0-12 hours
measure: Time of max plasma concentration for assumed key active
timeFrame: 0-12 hours
measure: AUC for plasma concentration versus time curve for assumed key active
timeFrame: 0-12 hours
measure: Half-life of elimination phase for assumed key active
timeFrame: 0-12 hours
measure: Total amount of assumed key active excreted in urine
timeFrame: 0-36 hours
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Research Organisation GmbH
Study officials:
affiliation: Charité Research Organisation GmbH
name: Christian Keicher, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02733640: Does Pantoprazole Reduce the Anti-platelet Effect of Clopidogrel?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antiplatelet Effect
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2016-04-11
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators sought to evaluate the influence of pantoprazole, indicated as less effective than other proton pump inhibitors, on the antiplatelet effect of clopidogrel, with stratification of the population according to the presence of cytochrome (CYP) 2C19 polymorphism.

Detailed description: Participants being treated with a maintenance dose of 75 mg clopidogrel and 100 mg aspirin daily after previous PCI with coronary stenting were included in the study. Participants were randomly assigned to either the pantoprazole 40 mg once-daily group or the ranitidine 150 mg twice-daily group using a computer-generated randomized table. An independent investigator generated the random allocation sequence. Blood samples were collected at 9:00 on day prior to treatment (day 0) and on day 9. Measuring impedance was performed by one independent investigator in a blinded manner.

Eligibility criteria: Inclusion Criteria:

* Patients being treated with a maintenance dose of 75 mg clopidogrel and 100 mg aspirin daily after previous PCI with coronary stenting were included in the study. All patients received standardized therapy with a loading dose of 600 mg of clopidogrel hydrogen sulfate and 400 mg aspirin.

All participants had a normal platelet count (150,000-450,000/mL).

Exclusion Criteria:

* Patients with severe liver disorders, current gastrointestinal disorders, a current infection, congestive heart failure, or a known bleeding disorder as well as patients on bivalirudin or glycoprotein IIb/III antagonists within the last 7 days were excluded from the study.

Primary outcomes:
measure: Number of participants with more than 5 Ω of impedance after intervention by an aggregometer which measures platelet aggregation in whole blood samples
timeFrame: 8 days
Secondary outcomes:
measure: Change of the impedance value (Ω) by an aggregometer which measures platelet aggregation in whole blood samples
timeFrame: baseline and 8days
measure: Number of participants with gastrointestinal bleeding
timeFrame: up to 2weeks
measure: Number of participants with reccured coronary artery disease
timeFrame: up to 2weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
citation: Choi YJ, Kim N, Jang IJ, Cho JY, Nam RH, Park JH, Jo HJ, Yoon H, Shin CM, Park YS, Lee DH, Jung HC. Pantoprazole Does Not Reduce the Antiplatelet Effect of Clopidogrel: A Randomized Controlled Trial in Korea. Gut Liver. 2017 Jul 15;11(4):504-511. doi: 10.5009/gnl16352.
Clinical trial NCT03729440: Evaluation of Esophageal Injuries in Corrosives in Assiut Governorate - Experimental Comparison Between Different Treatments
Official title: Evaluation of Esophageal Injuries in Corrosives in Assiut Governorate - Experimental Comparison Between Different Treatments
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Clinico-epidemiological Characteristics of Corrosive Patients Presenting at Assiut Governorate
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases diagnosed as acute corrosive toxicity which admitted to emergency unit Assiut University Hospital ,children university hospital and ministry of health hospitals in Assiut in duration of one year.

Brief summary: Esophageal stricture is one of the most common sequelae of caustic injury. Up to 70% of patients with grade IIB and more than 90% of patients with grade III injury are likely to develop esophageal stricture. Stricture formation can be prevented by suppressing fibrosis and scar formation therefore; many agents are explored for treatment on various models in this subject.

Detailed description: In spite of the multiple efforts to educate the public, Caustic ingestion maintains its place as an important public health issue due to the availability of caustic agents and the loose regulatory control on its production. All the cases will be evaluated by detailed history and thorough physical examination and necessary investigations. Patient's sheet will include; name, age, sex, occupation, residence, type of administrated substance, route and mode of exposure, symptoms and sighs (pain , vomiting , diarrhea) and any received treatment.

Eligibility criteria: Inclusion Criteria:

-1- All the cases with the primary diagnosis of acute caustic injury will be included in the study.

2- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

* 1- Caustic substance ingested patient with any chronic disease. 2- Patients with history of congenital esophageal stricture. 3- Unable to provide informed consent. 4- Unlikely to return at 8 weeks. 5- Ingestion of substances other than corrosive (co-ingestion).

Primary outcomes:
measure: fate of cases
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04686240: Doppler Ultrasonographic Assessment of Fetal Internal Thoracic Artery Indexes
Official title: Doppler Ultrasonographic Assessment of Fetal Internal Thoracic Artery Indexes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy Related
Fetal; Circulation
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 150
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy fetuses between 24th and 32nd gestational weeks

Brief summary: The aim of this study is to assess the feasibility of visualizing the internal thoracic artery (ITA), establishing the normogram for ITA pulsatility index (PI), resistance index (RI) and acceleration/ejection time (AT/ET) at 24-32 weeks.

Detailed description: Background: The internal thoracic artery arises from the subclavian artery as the first branch. It travels downward on the inside of the rib cage and then gives off six main branches; mediastinal, thymic, pericardiacophrenic, sternal, perforating and intercostal branches.

In literature, there are so many articles that have been focused on thymus size in pregnancies complicated with diabetes mellitus, fetal growth restriction, preterm rupture of membranes and so on. To the best of our knowledge, there is no paper about fetal ITA whose branch are feeding vessel of thymus and ITA Doppler velocity. The arteries supplying the thymus are branches of the internal thoracic, and inferior thyroid arteries. As far as it has been known, growing of a tissue depends on increased blood flow. Before detecting possible blood-flow changes in fetuses complicated with great obstetrics patologies, the investigators should obtain normal values of ITA Doppler velocity.

Eligibility criteria: Inclusion Criteria:

* singleton pregnancy
* having no fetal anomalies
* healthy pregnant women age \>17 and \<45 years
* between 24th-32nd gestational weeks

Exclusion Criteria:

* fetuses with congenital aneuploidy or structural malformation
* underlying chronic diseases
* pregnant women complicated with gestational diabetes, Type 1-2 DM, hypertension (pregnancy-induced; chronic; preeclampsia), malignancy
* pregnancy complicated with preterm premature rupture of membranes, preterm labour, fetal growth restriction and another obstetric complication

Primary outcomes:
measure: Doppler indices for internal thoracic artery
timeFrame: Between 24th and 32nd gestational weeks
measure: assessment of fetal thymus size
timeFrame: Between 24th and 32nd gestational weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ankara City Hospital Bilkent
name: betül yakıştıran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara City Hospital Bilkent
name: aykan yücel, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara City Hospital Bilkent
name: mihriban alkan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ankara city hospitalBilkent
name: seval erdinç, assoc prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00609440: Morquio's Syndrome: a Case Study
Official title: Morquio's Syndrome: a Case Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Morquio's Disease
Keywords: Morquio's disease; physiotherapy; results
Lead sponsor: Clínica de Hidroterapia e Recuperacao Funcional
Sponsor class: OTHER
Collaborators: name: Integrated Faculty of Recife
First posted: 2008-02-07
Enrollment: 1
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: Relating about the benefits proportionated by the physiotherapeutic treatment for the patients that have the Morquio's syndrome. METHODS: This study intends to analyse a patient that presents this syndrome, describing the physiotherapeutic treatment that was proposed and the evolution clinical.


Eligibility criteria: Inclusion Criteria:

* The parents agreed with the study;
* The parents signed a consent term

Exclusion Criteria:

* The treatment disturbed the patient physically or emotionally;
* The parents didn't signed the consent term;
* The patient refused to be treated.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Employee
name: Maria do Carmo Pinto Neta, Post-graduated
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06265740: Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota
Official title: Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Birth
Vaginal Flora
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Objectives: to assess the relevance of the RiboTaxa algorithm coupled with neural network learning based on analysis of vaginal microbiota metagenomic sequencing data for predicting prematurity in an identified at-risk population.

Study description: Longitudinal follow-up of a cohort of pregnant women, with collection of biological samples, and a posteriori case-control comparison based on the occurrence of an event (premature birth).

Detailed description: There is currently no reliable clinical or biological diagnosis to predict premature birth. Recent work using metagenomic data analysis coupled with artificial intelligence approaches suggests that there may be a vaginal microbiota signature during pregnancy that correlates with the occurrence of preterm birth. The aim of the study is to use biological samples to confirm the identification of these vaginal microbiota signatures as a means of predicting preterm birth.

Eligibility criteria: Inclusion Criteria:

* Pregnant women Admitted to the Clermont-Ferrand University Hospital maternity ward from 14 weeks' gestation onwards
* For threat of preterm birth (PTB) characterized by contractile activity and/or cervical changes, or for premature rupture of fetal membranes (PROM)
* And in need of vaginal swabbing
* Single or multiple pregnancy
* Able to understand and object to the study
* Covered by a French social security scheme.
* Give informed consent for the study

Exclusion Criteria:

* Patient under guardianship, curatorship or safeguard of justice
* Patient having received antibiotic therapy in the 2 weeks prior to admission

Primary outcomes:
measure: Early diagnosis of preterm birth using vaginal microbiota analysis
timeFrame: at birth
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Denis Gallot
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00092040: A Study and 12 Month Extension to Evaluate Two Investigational Drugs in Postmenopausal Women With Osteoporosis (MK-0217-907)
Official title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter Study to Evaluate and Compare the Effects of Alendronate and Risedronate on Bone Mineral Density in Postmenopausal Women With Osteoporosis; A 12 Month Extension to: A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter Study to Evaluate and Compare the Effects of Alendronate and Risedronate on Bone Mineral Density in Postmenopausal Women With Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis, Postmenopausal
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-24
Enrollment: 936
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study and 12 month extension is to evaluate the effects of two investigational drugs on osteoporosis in postmenopausal women.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women with osteoporosis

Exclusion Criteria:

* Any known allergy to the study drug

Primary outcomes:
measure: Mean percent change from baseline in hip trochanter bone mineral density (BMD)
Secondary outcomes:
measure: Mean percent change from baseline in PA lumbar spine, total hip, and femoral neck BMD
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Reid DM, Hosking D, Kendler D, Brandi ML, Wark JD, Weryha G, Marques-Neto JF, Gaines KA, Verbruggen N, Melton ME. Alendronic acid produces greater effects than risedronic acid on bone density and turnover in postmenopausal women with osteoporosis : results of FACTS -international. Clin Drug Investig. 2006;26(2):63-74. doi: 10.2165/00044011-200626020-00002.
citation: Reid DM, Hosking D, Kendler D, Brandi ML, Wark JD, Marques-Neto JF, Weryha G, Verbruggen N, Hustad CM, Mahlis EM, Melton ME. A comparison of the effect of alendronate and risedronate on bone mineral density in postmenopausal women with osteoporosis: 24-month results from FACTS-International. Int J Clin Pract. 2008 Apr;62(4):575-84. doi: 10.1111/j.1742-1241.2008.01704.x.
Clinical trial NCT03487640: Surgical Treatment for ODS With Rectal Prolapse Surgical Treatment for Rectal Prolapse
Official title: Laparoscopica Hindgut Resection Plus Rectum Suspention Compare With Transanal Rectal Mucosa Resection for ODS With Rectal Prolapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Constipation by Outlet Obstruction
Keywords: constipation, surgery
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2018-04-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Meet for Rome IV criteria for constipation.

Brief summary: Chronic obstinate constipation is hard to deal with in clinic. Especially for obstructed defecation syndrome(ODS). Rectal prolapse is the most common type of ODS. Lots of surgical procedures have been suggested for it but with unsatisfactory results.To develop new surgical treatment and to provide higher quality proof for this intractable condition is of significance.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with ODS by defecography, coloscopy, barium enema and dynamic MRI.
* Patients should accord with Rome IV criteria.

Exclusion Criteria:

* Severe heart or other organ disease.
* test.

Primary outcomes:
measure: Wexner constipation score
timeFrame: 2019.1-2019.12
measure: patients' satisfaction rate
timeFrame: 2019.1-2019.12
Secondary outcomes:
measure: short period complications
timeFrame: 2018.1-2019.12
measure: operative time
timeFrame: 2018.1-2019.12
measure: quality of life
timeFrame: 2019.1-2019.12
Other outcomes:
Locations:
city: Yuzhong
country: China
facility: Weidong Tong
state: Chongqing
Study officials:
affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: Yong Yang, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT00224640: Iron-Chelating Therapy and Friedreich Ataxia
Official title: Effect of Iron-Chelating Therapy in Friedreich Ataxia. Study Phase I/II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Friedreich Ataxia
Keywords: Iron-chelating treatment
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-09-23
Enrollment: 15
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Friedreich ataxia, an autosomal recessive condition, ascribed to frataxin gene expansion, has been shown to result from an iron- induced injury to the mitochondrial respiratory chain. Buffering free radicals with short-chain quinones (Idebenone) protects the patients against cardiomyopathy but not CNS involvement. Removing CNS iron should limit the impact of the neurological symptoms of the disease.

Detailed description: The current clinical trial is a monocentric open phase1-2 trial in the context of rare diseases framework, aimed to the goal of defining the tolerance/efficacy of the treatment.

Inclusion criteria: minimum age: 13 years Follow up in the Dept of Genetics, Hospital Necker-Enfants Malades, Paris, France

Eligibility criteria: Inclusion Criteria:

1. Minimum age: 13 years
2. Molecular confirmation of frataxin gene mutation
3. Iron overload evaluation
4. Presence of lactate
5. Echography response to Idebenone treatment
6. Urinary test of pregnancy for girls
7. Sexual abstinence for men
8. Information consent

Exclusion Criteria:

1. No disturbance of iron metabolism
2. No response to Idebenone
3. Friedreich not confirmed
4. Polynuclear neutrophils \<2 x 109/L or hemoglobin \< 8g/dL
5. No participation to other trial
6. Doubt regarding the compliance of the patient to protocol
7. Impossibility to undergo X-ray examination or presence of iron material in the backbone
8. Pregnant women
9. Absence of social insurance.

Primary outcomes:
measure: assessment of iron overload at TO and month2 by imagery
timeFrame: at months :0, 1 ,2 ,4 ,6
Secondary outcomes:
measure: Clinical (monthly) and biological parameter follow- up ( blood count,
timeFrame: weekly
measure: plasma iron, ferritin, transferrin and liver enzymes)
timeFrame: every months
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Arnold MUNNICH, Pr,MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: