louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02467972: Functional Ingredients: Effect in Gastrointestinal System
Official title: Functional Ingredients: Effect in Satiety and Intestinal Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Diabetes
Constipation
Keywords: Hunger and satiety
Hormones gastrointestinal
Bowel movements
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2015-06-10
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The addition of fructans or unripe banana flour to frozen meals can change the hormonal parameters related to hunger and satiety, improve the bowel movements and increase in colonic bacteria population measured by microbiological determinations (qPCR). The inulin no can change bowel movements and increase in colonic bacteria population measured by microbiological determinations (qPCR)

Detailed description: Non-transmissible chronic diseases have been constantly related to the consumption of diets with inadequate nutrient input; at the same time, the ingestion of unavailable carbohydrates have presented an inverse relationship with the risk for these diseases. Among these carbohydrates is inulin, a fructan considered as a prebiotic and the unripe banana flour, rich in resistant starch, which may contribute to the intestinal health.

This study evaluated the effect of regular intake of frozen soups added functional ingredients (fructans and unripe banana flour) by heath volunteers, about gastrointestinal hormones, satiety and bowel movements.

Eligibility criteria: Inclusion Criteria:

- good health condition

Exclusion Criteria:

* history of renal or gastrointestinal disease
* hyperthyroidism
* diabetes, nor parents with diabetes
* for women: not pregnant, breastfeeding or using hormonal therapy
* using any drug that might affect the digestion of food and absorption (antibiotics, laxatives)

Primary outcomes:
measure: Change in hormonal parameters related to hunger and satiety.
timeFrame: 6 weeks
measure: Change in bowel function
timeFrame: 6 weeks
measure: Change in colonic bacteria population
timeFrame: 6 weeks
measure: Change in satiety
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in biochemical parameters
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Faculty of Pharmaceutical Sciences USP
Study officials:
affiliation: Faculty of Pharmaceutical Sciences of University of Sao Paulo
name: Elizabete W Menezes, Prof Assoc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05767372: Effect of Coherent Breathing on Elderly Quality of Life
Official title: Effect of Coherent Breathing on Different Outcome Measures in Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stable Diabetes Mellitus
Geriatrics
Hypertension
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be carried out on sixty elderlies of both gender with ages ranges from 60 to 70 years old. The participants will receive Inspiratory muscle trainer and/or Coherent breathing exercise three times per week for 12 weeks.


Eligibility criteria: Inclusion Criteria:

1. Elderly subject of both gender with age ranged from 60 to 70 years old.
2. BMI will be ranged from 25 to 29.9.
3. Clinically and medically stable.
4. Able to understand the requirements of the study.
5. Conscious patient and respond to verbal command.

Exclusion Criteria:

1. Neurological conditions (e.g., stroke history, Parkinson's disease).
2. Presence of an acute illness.
3. Metabolically unstable chronic illness.
4. Pre-existent untreated metabolic or renal disease.
5. Patient undergoes chemotherapy.
6. Recent surgery.
7. Uncontrolled diabetes or hypertension.

Primary outcomes:
measure: Tinetti Performance Oriented Mobility Assessment (POMA)
timeFrame: 12 weeks
measure: The five Times Sit to Stand Test
timeFrame: 12 weeks
measure: The muscle quality index (MQI)
timeFrame: 12 weeks
measure: The Geriatric Depression Scale (GDS)
timeFrame: 12 weeks
measure: The 6 minutes' walk test (6MWT)
timeFrame: 12 weeks
measure: Short form Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
timeFrame: 12 weeks
measure: Evaluation of oxygen saturation (SPO2) and heart rate (HR)
timeFrame: 12 weeks
Secondary outcomes:
measure: Modified Borg Dyspnoea Scale
timeFrame: 12 weeks
measure: Evaluation of forced expiratory volume at one second (FEV1) and maximum voluntary ventilation (MVV)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of physical therapy outpatient clinic
state: Giza
Study officials:
affiliation: May University
name: Sherif O Elabd, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00801372: Use of Existing Fibroblast Cells to Convert to Induced Pluripotent Stem Cells
Official title: Use of Existing Fibroblast Cells to Convert to Induced Pluripotent Stem Cells
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnant, Healthy Females
Healthy Male Newborns
Keywords: termination of pregnancy
surgical circumcision
umbilical cord
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2008-12-03
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant, healthy females older than 18 who signed an informed consent for the termination of the pregnancy.

pregnant healthy couples older than 18 who signed an informed consent for a c-section.

healthy male newborns, undergoing surgical circumcision who's parents older than 18 signed an informed consent.

Brief summary: Induced pluripotent stem cells potentially may be useful in the future as an unlimited source of cells for transplantation.

The major goal of the project is to develop human iPS cells from existing lines of fibroblasts that were originally donated as clinical grade feeders for the development of clinical grade hESCs. The clinical grade feeders were developed from aborted fetuses, foreskin and umbilical cord.

Detailed description: The potential to reprogram somatic cells into an embryonic state raises multiple basic research questions related both to the process of reprogramming and the properties of iPS cells. We will use various approaches to study the molecular mechanisms and processes that occur during reprogramming. We will use various experimental systems to characterize and study the properties of the iPS cells, their biology, developmental potential, capability to give rise to functional differentiated progeny etc.

The clinical grade donated feeders used in this project were developed under GMP conditions using animal-free reagents. For potential future clinical applications, the iPS cells will be developed under GMP conditions, using reagents and methods that will be acceptable for clinical applications.

Eligibility criteria: Inclusion Criteria:

* healthy, older than 18

Exclusion Criteria:

* non healthy, younger than 18

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Ein Kerem
Study officials:
affiliation: Chairman of Department of Obstetrics & Gynecology/IVF, Hadassah Ein Kerem
name: Benjamin E Reubinoff, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Takahashi K, Tanabe K, Ohnuki M, Narita M, Ichisaka T, Tomoda K, Yamanaka S. Induction of pluripotent stem cells from adult human fibroblasts by defined factors. Cell. 2007 Nov 30;131(5):861-72. doi: 10.1016/j.cell.2007.11.019.
Clinical trial NCT02921672: Feasibility Trial of a Mediterranean Diet Pattern to Prevent Cognitive Decline
Official title: Feasibility Trial of a Mediterranean Diet Pattern to Prevent Cognitive Decline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Cognitive Impairment
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2016-10-03
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: By doing this study, researchers hope to learn if older adults with and without cognitive impairment can adhere to a Mediterranean diet.

Detailed description: Participants will be given instruction on following the study designed Mediterranean diet. Participation in the study will last about 9 weeks. Each person will be asked to follow the study diet for 6 weeks. During the study, participants will be asked to track the food they eat and will be monitored by a registered dietitian.

Potential participants need to be located within the KC metro area.

Eligibility criteria: Inclusion Criteria:

* Cognitively normal older adults over the age of 65 or individuals with a diagnosis of MCI or AD (any age)
* Have a study partner, if diagnosed with MCI or AD
* Body mass index (BMI) range between 20 - 35 kg/m2
* Speak English as a primary language

Exclusion Criteria:

* Serious medical risk
* Adherence to specialized diet regimes
* Already consume a Mediterranean diet pattern

Primary outcomes:
measure: Number of participants completing the study
timeFrame: Week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Deborah K Sullivan, PhD, RD, LD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01690572: Drug Eluting Balloon for Prevention of Constrictive Remodeling
Official title: Drug Coated Balloon (DCB) for the Prevention of Constrictive Remodeling and Restenosis in Small Vessel Coronary Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Disease
Diabetes Mellitus
Keywords: drug eluting balloon
constrictive remodeling
Lead sponsor: Herz-Zentrums Bad Krozingen
Sponsor class: OTHER
First posted: 2012-09-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Earlier studies indicated that Percutaneous coronary intervention (PCI) may be problematic in diffuse small vessel disease especially of diabetic patients. High restenosis rates after balloon only procedures in small vessels occur due to negative constrictive vessel remodeling if DES (drug eluting stents) are not used and prolonged anti-platelet therapy is not indicated. The main hypothesis of the trial is that in analogy to DCB success in peripheral arterial disease (PAD), cellular toxicity of the drug paclitaxel eluting from a IN.PACT FalconTM DCB will prevent constrictive remodelling of small coronary vessel segments after dilatation. The IN.PACT FalconTM DCB is compared with plain old balloon angioplasty (POBA) using a Sprinter LegendTM balloon in small vessel coronary artery disease. A constrictive remodelling process will be measured by optical coherence tomography (OCT) at 9 months median F/U. This pilot trial is planned to be randomized 1:1 for DCB against POBA therapy.


Eligibility criteria: Inclusion Criteria:

* at least one target lesion with a stenosis severity ≥ 50% in one coronary segment with a diameter ≤ 2.5 mm
* age \> 18 years
* weight \> 45 kg
* patient suitable for balloon dilatation and not suitable for elective implantation of a drug eluting stent
* insulin-dependent or non-insulin-dependent diabetes mellitus
* length of lesion ≥ 15 mm

Exclusion Criteria:

* Life expectancy \< 12 months
* In-Stent restenosis
* planned coronary bypass or heart valve OP
* ST elevation myocardial infarction within the last 72 hours
* cardiogenic shock
* renal impairment or liver dysfunction (creatinine \> 2.0 mg/dl, AST/ALT \> 3x of normal value
* incompliance
* pregnant or breastfeeding women or women who like to be pregnant

Primary outcomes:
measure: MACE-rate
timeFrame: 12 months after initial treatment
Secondary outcomes:
measure: OCT-measurement
timeFrame: during follow-up, after 9 months
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Department of Cardiology and Angiology I, Heart Center,
state: Baden-Württemberg
Study officials:
affiliation: Department of Cardiology and Angiology I, Heart Center, Freiburg University
name: Christoph Hehrlein, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03718572: Evaluation Of Preoperative Scoring Method For Peridiction Of Difficult Laparoscopic Cholecystectomy
Official title: Evaluation Of Preoperative Scoring Method For Peridiction Of Difficult Laparoscopic Cholecystectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Evaluation Studies
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults male and female age of or above 18 years

Brief summary: Registering and observing clinical and radiological data of patients undergoing laparoscopic cholecystectomy, then formulating these data aiming to find helpful scoring system to predict difficulty of laparoscopic cholecystectomy.

Detailed description: Patients with symptomatic chronic calculous cholecystitis based on clinical and radiological correlation undergoing elective laparoscopic cholecystectomy at Assiut University hospitals will be included for the study of 30 patients will operated by single experienced laparoscopic surgeon.The scores are given on history, clinical examination and radiological findings one day prior to surgery on admission.

Eligibility criteria: Inclusion Criteria:

* Adults male and female age of or above 18 years
* Symptomatic chronic calculous cholecystitis
* Ultrasound confirmed Gall bladder stones

Exclusion Criteria:

* Complicated chronic calculous cholecystitis
* Malignant Gall bladder

Primary outcomes:
measure: Evaluation of preoperative scoring method for prediction of difficult laparoscopic cholecystectomy
timeFrame: 6 monthes
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University hospitals
Study officials:
References:
Clinical trial NCT00744172: Finhyst 2006: Study on Morbidity of Hysterectomies in Finland
Official title: Finhyst 2006: Incidence, Methods, Complications and Effect on Quality of Life of Hysterectomies in Finland in 2006
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbidity of Hysterectomy
Keywords: hysterectomy
vaginal
laparoscopy
abdominal
complication
quality of life
cost-effectiveness
Morbidity of three types of hysterectomy
Lead sponsor: Society for Gynecological Surgery in Finland
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
First posted: 2008-08-29
Enrollment: 5279
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to analyze prospectively all hysterectomies performed in Finland for benign indications including all 46 public hospitals performing hysterectomies and also 7 private clinics. Hypothesis is that vaginal and laparoscopic hysterectomies are safe and cost-effective methods of hysterectomy.

Detailed description: This Finhyst 2006 study evaluates nationwidely methods, indications, concomitant procedures, complications, hospital stay and convalescence time of all types of hysterectomies with questionnaires filled by doctors and patients. In addition, in the area of Helsinki University Central Hospital also the effect of quality of life and cost-effectiveness is studied.

Eligibility criteria: Inclusion Criteria:

* Bening indications for hysterectomy

Exclusion Criteria:

* Malignant indications for hysterectomy
* Postpartum hysterectomy

Primary outcomes:
measure: Safety of hysterectomy
timeFrame: 1.1-31.12.2006
Secondary outcomes:
measure: Cost-effectiveness
timeFrame: 1.1.-31.12.2006
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
Study officials:
affiliation: Member of Society of Gynecological Surgery in Finland
name: Päivi SM Härkki, MD
role: STUDY_DIRECTOR
References:
citation: Makinen J, Brummer T, Jalkanen J, Heikkinen AM, Fraser J, Tomas E, Harkki P, Sjoberg J. Ten years of progress--improved hysterectomy outcomes in Finland 1996-2006: a longitudinal observation study. BMJ Open. 2013 Oct 28;3(10):e003169. doi: 10.1136/bmjopen-2013-003169.
citation: Brummer TH, Heikkinen AM, Jalkanen J, Fraser J, Makinen J, Tomas E, Seppala T, Sjoberg J, Harkki P. Antibiotic prophylaxis for hysterectomy, a prospective cohort study: cefuroxime, metronidazole, or both? BJOG. 2013 Sep;120(10):1269-76. doi: 10.1111/1471-0528.12178. Epub 2013 Jun 21.
citation: Brummer TH, Heikkinen A, Jalkanen J, Fraser J, Makinen J, Tomas E, Seppala T, Sjoberg J, Harkki P. Pharmaceutical thrombosis prophylaxis, bleeding complications and thromboembolism in a national cohort of hysterectomy for benign disease. Hum Reprod. 2012 Jun;27(6):1628-36. doi: 10.1093/humrep/des103. Epub 2012 Mar 14.
Clinical trial NCT04423172: Safety, Efficacy and Operability of Using the New Tissue Containment System During Laprascopic Hysterectomy
Official title: Safety, Efficacy and Operability of Using the New Tissue Containment System With Hard Pipes Which Can Assemble With Detachable Trocars Seamlessly for Tissue Removal During Laprascopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecologic Surgery
Keywords: morcellation
laparoscopic surgery
hysterectomy
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed to evaluate the safety, operability and efficacy of performing the new tissue containment system during laparoscopic hysterectomy. Pre- and perimenopausal women undergoing laparoscopic hysterectomy.


Eligibility criteria: Inclusion Criteria:

* Pre- and Peri-menopausal woman patient age 18-65 years
* Women with fibroids, adenomyosis, and endometrial hyperplasia and indication for laparoscopic hysterectomy.
* Normal Pap smear result within one year
* The uterus is larger than 12 weeks of gestation
* The body mass index of the patients is 18.5-27.9kg/m2
* Signed informed consent form

Exclusion Criteria:

* Women with Known or suspected malignancy
* patients during pregnancy and lactation
* Known blood diseases, bleeding coagulation disease, any part of the active bleeding or bleeding tendency of the constitution of the patient
* Patients with known severe liver and kidney dysfunction;Liver function (ALT, AST) ≥ 2 times of normal upper limit, or renal function (Cr) ≥ normal upper limit
* Patients who are known to have participated in any other clinical trial within 3 months
* Patients who cannot sign informed consent
* Patients with acute stage infection of the reproductive system or other sites

Primary outcomes:
measure: The exposure rate
timeFrame: approximately two years
Secondary outcomes:
measure: Mean procedure time
timeFrame: Within one day after the surgery
measure: The probability of failure during in-bag morcellation procedure
timeFrame: approximately two years
measure: Estimated blood loss during operation
timeFrame: Within one day after the surgery
measure: Post-operative pain
timeFrame: Within one month after the surgery
measure: Rate of intra- or post-operative complications
timeFrame: Three months after the surgery
measure: The Surgeon Task Load Index
timeFrame: Within one week after the surgery
measure: The Patients' life quality postoperative
timeFrame: One months after the surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03758872: CUFF-assisted Colonoscopy vs Standard Colonoscopy
Official title: USE OF ENDOCUFF SECOND GENERATION IN THE COLIC POLYPS DETECTION: HISTORIC COHORTE PROSPECTIVE COMPARATIVE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonic Polyp
Colonoscopy
Lead sponsor: Clinique du Trocadéro
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 1034
Sex: ALL
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: Patient of all participating physicians for total colonoscopic exploration over the study periods

Brief summary: The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate in routine colonoscopy.

This is a prospective comparative cohort, on 1034 patients, 517 patients with ECV in prospective group and 517 without ECV in retrospective group


Eligibility criteria: Inclusion Criteria:

* Patient scheduled for total colonoscopic exploration, during the period study
* Patient over or equal to 18 years
* ASA 1, ASA 2, ASA 3
* No participation in another clinical study
* Certificate of non opposition signed

Exclusion Criteria:

* Patient under 18 years old
* ASA 4, ASA 5
* Pregnant woman
* Patient with coagulation abnormalities preventing polypectomy: prothrombin level \<50%, -Platelets \<50000 / mm3, effective anti-coagulation in progress, clopidogrel in progress.
* Inflammatory bowel disease
* Known colonic stenosis
* Diverticulitis less than 6 weeks old
* Patient unable to give consent or protected by law
* Opposition expressed for inclusion in the study

Primary outcomes:
measure: detection of polyp or adenoma with cuff
timeFrame: during procedure
Secondary outcomes:
measure: POLYP DETECTION RATE
timeFrame: during procedure
measure: morbidity : perforation rate
timeFrame: 21 DAYS AFTER PROCEDURE
measure: CAECAL INTUBATION RATE
timeFrame: DURING PROCEDURE
measure: TIME TO REACH CAECUM
timeFrame: DURING PROCEDURE
measure: WITHDRAWAL TIME
timeFrame: DURING PROCEDURE
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinique Du Trocadero
Study officials:
References: