louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03056664: The Role of MSC in the Treatment of Fistulas in Patients With Perianal Crohn's Disease
Official title: The Safety and Efficiacy of Local MSC Injection in the Treatment of Fistulas in Patients With Perianal Crohn's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Crohn's Disease
Fistula
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-02-17
Enrollment: 3
Sex: ALL
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: Here investigators will carry out this phase II clinical trial to explore a effective therapeutic regimen of MSC in the Crohn's perianal fistula.

Detailed description: Peri-anal fistula is common seen in Crohn's disease. Treatments including surgery, antibiotics, immunosuppressive drug and infliximab improve the quality of life of the patients suffering Crohn's perianal fistula, but the recurrent rate is still high. MSC showed promising effect in the therapy of CD, but the standard treatment strategy is unclear. Here investigators will carry out this phase II clinical trial to explore a effective therapeutic regimen of MSC in the Crohn's perianal fistula.

Eligibility criteria: Inclusion Criteria:

1. Age 18-65 years old, male or female;
2. refractory CD fistula, there are 1-2 and 1-3 in the mouth fistula;
3. Diagnostic CD at least three months;
4. CDAI \<250;
5. were receiving drug treatment (5-ASA and hormones\> 4 weeks, immunosuppressants and biological agents\> 8 weeks);
6. signed informed consent.

Exclusion Criteria:

1. with intestinal obstruction, stenosis, or perianal abscess;
2. pregnant or lactating women;
3. infection needs antibiotics persons;
4. rectovaginal fistula;
5. complex anal fistula more than two inside the mouth;
6. stenosis or perforation CD;
7. perianal infection;
8. could not do rectal or anal stenosis local injection therapy;
9. with acute enteritis;
10. , liver and kidney dysfunction;
11. a month have used other drugs are in clinical trials;
12. no conditions or unwilling to carry out MRI inspected;
13. who are adjusting therapy;
14. HIV patients;
15. The combined active hepatitis or tuberculosis; Occurred in 16) 6 months opportunistic infections, or severe infections occur within three months;

17) In the past five years, those who suffer from cancer; 18) there is a history of lymphoproliferative disease.

Primary outcomes:
measure: Clinical response(fistula closure)
timeFrame: 12 weeks
Secondary outcomes:
measure: C-reactive protein (CRP)
timeFrame: 12 weeks
measure: Clinical Response
timeFrame: 6 weeks after receiving treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00772564: The Use of Statins for Myocardial Death Prevention
Official title: The Use of Statins for Myocardial Death Prevention: From Cell to Bedside
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Keywords: Acute ST Elevation Myocardial Infarction
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-10-15
Enrollment: 25
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The administration of high dose HMG-CoA reductase inhibitors (Statins) to patients with acute ST-elevation MI (hypoxia/ischemia) who are treated with primary PCI (reoxygenation/ reperfusion) will protect their cardiomyocytes from death and thus preserve LV ejection fraction.


Eligibility criteria: Inclusion Criteria:

1. Patients suffering from acute ST elevation resulting from myocardial infarction, Killip Classification 1 and 2 will be included at-random to either group. Included subjects should be able to give their informed consent to participate in this study.

Exclusion Criteria:

1. The impossibility to give the required informed consent.
2. Known allergy to Atorvastatin.
3. Base line serum creatinine of 1.4 mg/dL.
4. Killip Classification 3 and 4.
5. Persisting vomiting.
6. History of previous liver disease.
7. History of previous muscle disease or rabdomyolisis.
8. Treated already with high dose atorvastatin
9. Non Compliance.

Primary outcomes:
measure: Heart EcoCardiography and specific laboratory tests
timeFrame: Base line, second day and 60 days after myocardial infarction
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Sammer Diab, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04694664: COVID-19 Vaccine Confidence Among Pregnant Women and Mothers
Official title: Vaccine Confidence Among Pregnant Women and Mothers During the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Mothers
Lead sponsor: Pregistry
Sponsor class: INDUSTRY
Collaborators: name: Harvard School of Public Health (HSPH)
First posted: 2021-01-05
Enrollment: 18000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women or women who have at least one child younger than 18 years of age.

Brief summary: The purpose of this study is to assess the level of vaccine confidence and influencers among pregnant women and mothers of school-aged children during the COVID-19 pandemic.

Detailed description: The WHO has listed "vaccine hesitancy" as one of the top threats to global health.

The COVID-19 pandemic has triggered the need to vaccinate worldwide as soon as a safe and efficacious vaccine becomes available. However preliminary data show that, on average, only 50% to 66% of US adults would be willing to receive COVID-19 vaccination when it becomes available, a percentage lower than what is required for herd immunity to control the pandemic. Furthermore, there is a pressing need to vaccinate children to reopen schools and keeping them safe, as well as to immunize pregnant women through vaccination programs since they constitute a vulnerable population. Vaccine confidence among pregnant women and mothers of school-aged children during the period of COVID-19 pandemic is unknown, leading to an important gap of knowledge that may hinder the upcoming global COVID-19 vaccination scale-up effort. It is therefore of critical importance to assess the level of vaccine confidence and influencers among pregnant women and mothers of school-aged children during the COVID-19 pandemic.

The international nature of the proposed survey will allow the evaluation of vaccine confidence and its influencers among pregnant women and mothers of school-aged children on a global level. Therefore, social and geographic characteristics from different countries and cultures will be available for comparison. The resulting knowledge will be relevant to a large percentage of the world's population. Any country in the world can participate.

Eligibility criteria: Inclusion Criteria:

* Pregnant women or women who have at least one child younger than 18 years of age. Able to give electronic informed consent

Exclusion Criteria:

* \<18 years of age

Primary outcomes:
measure: Percentage of acceptance of a COVID-19 vaccine
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Pregistry
state: California
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Julia Wu, SD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04681664: Gut Microbiome Based Analysis of High Protein High Fat Diet
Official title: Development of Methods and Algorithms to Design Diets Based on Gut Microbiome Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: microbiome
ribosomal sequencing
obesity
bifidobacteria
Collinsella
Lead sponsor: Center of Food and Fermentation Technologies
Sponsor class: OTHER
Collaborators: name: National Institute for Health Development, Estonia
First posted: 2020-12-23
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study was to determine body mass reduction and microbiota composition change after the weight loss diet (50 % fat, 25 % proteins and 25 % carbohydrates).

Detailed description: For high fat group a total of 19 overweight/obese participants (14 females, 5 males, aged 25 to 43) with BMI of 28.9-44.4 kg/m2 were assigned to low-calorie low-carbohydrate high-fat weight loss diet for 4 weeks.

As a control group, 58 subjects (39 females, 20 males, aged 24 to 55 years) were recruited and divided into 3 groups based on BMI: 18-25, 25-30, 30-39 kg/m2 (N=33, N=16, N=9, respectively).

Inclusion criteria for participants included no previous history of gastrointestinal (GI) disease, no reported antibiotic use in preceding 3 months, or taking any medication known to alter bowel motility, no history of food allergies and not taking medications.

Before the study all participants were informed about the study and participants were signed a written consent.

At day 0 baseline samples and data were collected (faecal sample, Bristol score and bowel habits, food diary about the period of at least three days before faecal sampling, body weight). After collection of baseline samples subjects in the high fat group started diet plan for 4 weeks while control group contiunued their habitual diet. After the 4 week intervention period samples and data were collected again (faecal sample, Bristol score and bowel habits, food diary about the period of at least three days before faecal sampling, body weight).

Eligibility criteria: Inclusion Criteria for obese group:

* BMI \> 30 g/m2

Exclusion Criteria:

* antibiotic treatment within last three months;
* food restrictions due to allergies, any kind of food intolerance, veganism/vegetarianism or other extremes in food consumption practices;
* chronic illnesses;
* current pregnancy or breastfeeding
* travel to subtropical or tropical regions within one month before the study.

Primary outcomes:
measure: Decrease of body weight during 4 weeks high fat diet
timeFrame: Baseline and after 4 weeks
measure: Reduction of inflammation related bacteria in faecal microbiota
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: Center of Food and Fermentation Technologies
state: Harjumaa
Study officials:
References:
Clinical trial NCT06354764: Propensity to Hospitalize Patients From the ED in European Centers.
Official title: Propensity to Hospitalize Patients From the ED in European Centers.An Observational Retrospective Quality-of-care Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Emergency Medicine
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
Collaborators: name: Astir S.r.l.
name: Centre Hospitalier Universitaire Vaudois
name: Orobix Life S.r.l.
name: Fondazione Bruno Kessler
First posted: 2024-04-09
Enrollment: 162000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients who arrived at participating emergency departments between January 1, 2021 and December 31, 2023

Brief summary: The peer-to-peer comparison means center-to-center comparison, which requires adjusting for possible differences among centers to be fair and convincing. The first step to reach this goal is to develop a predictive model that accurately estimates each patient's probability of being admitted, starting from clinical conditions and boundary variables. Such a model would make it possible to calculate, for each ED, the expected hospitalization rate; that is, the hospitalization rate that would have been observed if the ED had behaved like the average of the EDs that provided the data to build the model itself. Comparing the observed hospitalization rate in the single ED with the expected rate derived from the model provides a rigorous method of comparing the department with the average performance, taking into account the characteristics of the patients treated and the conditions under which the ED operated. In other words, the predictive model represents the benchmark against which each ED is evaluated.


Eligibility criteria: Inclusion Criteria:

* Adult
* Arrived at emergency department between 1 January 2021 and 31 December 2023

Exclusion Criteria:

* None

Primary outcomes:
measure: Create two separate databases
timeFrame: September 2024 - September 2025
measure: Multivariable models
timeFrame: September 2025 - September 2026
measure: Adjusted comparison
timeFrame: September 2025 - September 2026
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Istituto Di Ricerche Farmacologiche Mario Negri
name: Guido Bertolini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01765764: Bimatoprost for the Treatment of Eyebrow Hypotrichosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Eyebrow Hypotrichosis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-01-10
Enrollment: 357
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: This study will evaluate the safety and efficacy of bimatoprost solution compared with vehicle in the treatment of eyebrow hypotrichosis (inadequate eyebrows).


Eligibility criteria: Inclusion Criteria:

-Adult participants with eyebrow hypotrichosis (inadequate eyebrow growth).

Exclusion Criteria:

* Patients with disease, infection, or abnormality of the eyebrow area
* Patients with permanent eyebrow loss due to over-grooming

Primary outcomes:
measure: Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale
timeFrame: Baseline, Month 7
Secondary outcomes:
measure: Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA)
timeFrame: Baseline, Month 7
measure: Change From Baseline in Eyebrow Darkness as Measured Using DMSIA
timeFrame: Baseline, Month 7
measure: Percentage of Participants With 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6
timeFrame: Month 7
Other outcomes:
Locations:
city: Houston
country: United States
state: Texas
city: Vancouver
country: Canada
state: British Columbia
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Carruthers J, Beer K, Carruthers A, Coleman WP 3rd, Draelos ZD, Jones D, Goldman MP, Pucci ML, VanDenburgh A, Weng E, Whitcup SM. Bimatoprost 0.03% for the Treatment of Eyebrow Hypotrichosis. Dermatol Surg. 2016 May;42(5):608-17. doi: 10.1097/DSS.0000000000000755.
Clinical trial NCT01228864: Brody Belt - Alternative Method of Securing a Patient's Urinary Drainage Bag
Official title: Brody Belt - Alternative Method of Securing a Patient's Urinary Drainage Bag
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Quality of Life
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2010-10-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Brody belt may help improve quality of life in patients using urinary drainage bags. PURPOSE: This clinical trial studies the Brody belt in improving the quality of life in patients using urinary drainage bags.


Eligibility criteria: Inclusion Criteria:

-\>18 years old

-All patients in the urology clinic at Roswell Park who currently use a urinary drainage bag for a period of at least 7 days prior to signing consent for the study and who are expected to use a urinary drainage tube for an additional period of 4 weeks or more based on the diagnosis

Primary outcomes:
measure: Quality of Life
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Khurshid Guru, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05427864: Comparison of Multiparametric Prostate MRI and Ga-68 PSMA PET Imaging in Prostate Cancer Staging
Official title: Comparison of Multiparametric Prostate MRI and Ga-68 PSMA PET Imaging in Prostate Cancer Staging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Prostate Cancer Stage
Lead sponsor: Gulhane Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-06-22
Enrollment: 47
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 47 male patients who will be evaluated with both imaging studies will be included in the study.
Primary purpose: DIAGNOSTIC

Brief summary: In this study, it is aimed to compare the lesion location, lesion size, local and distant metastases detection rates of Ga68 PSMA PET and Multiparametric Prostate MR imaging tests used in staging in patients diagnosed with prostate cancer.

The pathologies of the patients who were decided to undergo radical prostatectomy as a treatment will also be compared with the staging tests.


Eligibility criteria: Inclusion Criteria:

* diagnosed with prostate cancer
* Gleason score 7 or above / 6 with high risk
* No other treatment

Exclusion Criteria:

* treated with radiotherapy
* treated with ADT

Primary outcomes:
measure: Lesion location
timeFrame: Between prostate biopsy and curative treatment decision , usually 2 month
measure: Lesion Size
timeFrame: Between prostate biopsy and curative treatment decision , usually 2 month
measure: Lymph node involvement
timeFrame: Between prostate biopsy and curative treatment decision , usually 2 month
measure: Extraprostatic involvement
timeFrame: Between prostate biopsy and curative treatment decision , usually 2 month
measure: Local and distant metastasis
timeFrame: Between prostate biopsy and curative treatment decision , usually 2 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane Research and Training Hospital
state: Etlik
Study officials:
References:
Clinical trial NCT03141164: Peripheral Vision Training Study
Official title: Peripheral Vision Training Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Impairment
Cognitive Change
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will train participants (young people and older adults) to do a visual task, and will assess whether this results in changes in behavioral assessments. In some participants, we will be also testing whether MRI measures (cortical thickness, functional connectivity) change with training.


Eligibility criteria: Inclusion criteria:

* Right handed individuals
* Aged 19-89
* In good health as self-reported or visual impairments due to partial vision loss
* Normal or corrected-to-normal vision with contact lenses or visual impairments due to partial vision loss

Exclusion criteria:

* Younger than 18 or older than 89
* Being hearing-impaired
* Not in good health except due to partial vision loss
* Having a previous serious head injury or neurological disorder, or loss of consciousness for more than 2 minutes
* Having hallucinations or delusions
* Having a current or past history of a substance abuse disorder
* Currently taking psychoactive medications

Primary outcomes:
measure: scores on acuity tests
timeFrame: baseline
measure: scores on acuity tests
timeFrame: immediately following training
measure: scores on spatial attention tests
timeFrame: baseline
measure: scores on spatial attention tests
timeFrame: immediately following training
Secondary outcomes:
measure: Changes in cortical thickness
timeFrame: baseline and immediately following training
measure: Changes in functional connectivity
timeFrame: baseline and immediately following training
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
References:
Clinical trial NCT02024464: Comparing Hydrus Microstent(TM) to the iStent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery
Official title: A Prospective, Multicenter, Randomized Comparison of the Hydrus Microstent to the iStent for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open Angle Glaucoma
Pseudoexfoliative Glaucoma
Pigmentary Dispersion Glaucoma
Keywords: Primary open angle glaucoma
POAG
Pseudoexfoliative glaucoma
PXG
Pigmentary dispersion glaucoma
PDG
Hydrus
Lead sponsor: Ivantis, Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-31
Enrollment: 306
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients. One of the two devices will be implanted immediately following cataract surgery and the placement of a posterior chamber intra-ocular lens. Only one eye (study eye) will be implanted.

Detailed description: This is a prospective, multicenter, single-masked, randomized clinical trial comparing Cataract Extraction (CE) + Hydrus Microstent to CE surgery + iStent implant for the reduction of intraocular pressure in patients with a positive diagnosis of primary open angle glaucoma, pseudoexfoliative glaucoma, or pigmentary dispersion glaucoma with an operable cataract. Eligible patients will be scheduled for cataract surgery. At the conclusion of successful cataract surgery and the placement of a posterior-chamber IOL, qualified subjects will be randomized to receive either the Hydrus Microstent or the iStent implant. Post-operative follow-up visits will be conducted at regular intervals.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of primary open angle glaucoma (POAG), Pseudoexfoliative (PXG) glaucoma, or Pigmentary dispersion glaucoma (PDG)
* An operable age-related cataract with BCVA of 20/40 or worse, eligible for phacoemulsification.

Exclusion Criteria:

* Forms of primary or secondary glaucoma not listed above
* Prior glaucoma surgery in the study eye

Primary outcomes:
measure: Unmedicated Mean Diurnal Intraocular Pressure (DIOP) at Month 12
timeFrame: Month 12: 8 am, 12 pm, 4 pm
Secondary outcomes:
measure: Percentage of Subjects With 20% Reduction From Baseline in Unmedicated DIOP at Month 12
timeFrame: Month 12: 8 am, 12 pm, and 4 pm
measure: Percentage of Subjects With Unmedicated DIOP of Not Less Than 5 mmHg and Not More Than 18 mmHg at Month 12
timeFrame: Month 12: 8 am, 12 pm, 4 pm
Other outcomes:
Locations:
Study officials:
References: