louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03978949: Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP)
Official title: Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP Trial): a Prospective, Randomized Controlled, Double Blinded, Single Center, Superiority Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Radiotherapy
Toxicity
Diarrhea
Probiotics
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 248
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In recent studies, a radiation-induced enteropathy is being reported over 50%. In clinics, probiotics are actively prescribed as a treatment for radiation-induced enteropathy. If probiotics can be used during radiation therapy to prevent or reduce radiation-induced enteropathy, the investigators can 1) reduce the inconvenience which is caused from intestinal toxicity, 2) reduce the unnecessary interruption of radiation therapy, and 3) expect to improve the quality of life.


Eligibility criteria: Inclusion Criteria:

* Histologically proven uterine cancer, ovarian cancer, vaginal cancer, vulvar cancer, ureter cancer, kidney cancer, urethral cancer, and prostate cancer
* Over 20 years of age
* Eastern Cooperative Oncology Group (ECOG) score 0-2
* Appropriate values of blood test within 6 months after enrollment Absolute neutrophil count (ANC) ≥ 1500 cells/mm3, platelets≥50000cells/mm3
* Appropriate values of kidney function within 6 months after enrollment Creatinin \< 2.0 ng/dL
* Appropriate values of liver function within 6 months after enrollment Total bilirubin \< 1.5 times upper limit normal range, alanine aminotransferase or aspartate aminotransferase \< 2.5 times upper limit normal range.
* Willing to provide informed written consent

Exclusion Criteria:

* History of pelvic irradiation
* Double primary cancer other than skin/thyroid cancer
* Combined serious morbidity
* Experience of other clinical trial within 1 month.

Primary outcomes:
measure: Number of participants with grade 2 or more acute intestinal toxicities
timeFrame: Adverse effect evaluated at 3 months after radiation therapy
Secondary outcomes:
measure: Number of participants with grade 2 or more chronic intestinal toxicities
timeFrame: Adverse effect occured after 3 months since end of radiation therapy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Young Seok Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim YJ, Yu J, Park SP, Lee SH, Kim YS. Prevention of radiotherapy induced enteropathy by probiotics (PREP): protocol for a double-blind randomized placebo-controlled trial. BMC Cancer. 2021 Sep 16;21(1):1032. doi: 10.1186/s12885-021-08757-w.
Clinical trial NCT03916549: Acupuncture in Low Anterior Resection Syndrome Treatment
Official title: The Role of Traditional Acupuncture in Low Anterior Resection Syndrome Treatment - Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Low Anterior Resection Syndrome
Lead sponsor: National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
Sponsor class: OTHER
Collaborators: name: Vilnius University
First posted: 2019-04-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One group of intervention - acupuncture for LARS patients
Primary purpose: TREATMENT

Brief summary: Acupuncture has it's role in treating patients with fecal incontinence and diarrhea-predominant irritable bowel syndrome. There is no trial or case-report assessing it's role in treatment of Low anterior resection syndrome.

Detailed description: Colorectal cancer is common in Western countries. For thirty years rectal cancer treatment is standardized: patients are undergoing low anterior resection with mesorectal excision +/- (chemo)radiotherapy. Unfortunately around 80% of patients undergoing low anterior resection will experience complex bowel dysfunction including fecal incontinence, soiling, urgency, incomplete evacuation, fragmented defecation and impaired rectal sensation known as low anterior resection syndrome (LARS) causing a "toilet dependence" which severely affects quality of life.

Still there is no standardized treatment for LARS.

Eligibility criteria: Inclusion Criteria:

* patients over 18 year
* signed written consent
* patients experiencing major low anterior resection syndrome
* patients at least one year following the surgery

Exclusion Criteria:

* allergy to stainless steal
* implanted pacemaker
* current skin infection
* needle phobia
* metastatic disease to the central nervous system (brain, spinal cord)
* at the same time, application of smecta, dicetel, cisapride or traditional Chinese medicine;

Primary outcomes:
measure: Bowel function changes after the treatment using Low anterior resection syndrome questionnaire
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: National Cancer Institute
Study officials:
References:
citation: Dulskas A, Aukstikalnis T, Kavaliauskas P, Samalavicius NE. The Role of Traditional Acupuncture in Low Anterior Resection Syndrome Treatment: A Pilot Study. Dis Colon Rectum. 2022 Jan 1;65(1):93-99. doi: 10.1097/DCR.0000000000002060.
Clinical trial NCT03598049: Assessment of Dental Implants Placed in Posterior Maxillary Ridge Using Densah Burs Versus Standard Drills
Official title: Assessment of Dental Implants Placed in Posterior Maxillary Ridge Using Densah Burs Versus Standard Drills
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Implant Site Reaction
Keywords: Implants
Stability
Bone loss
Success
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 30
Sex: ALL
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: comparing the drilling technique of using densah burs osseo densification drills in posterior maxilla with the normal surgical kit drilling

Detailed description: the densification of bone using the densah burs are thought to be improving the bone quality surrounding the implants thus increasing the primary stability and decreasing the marginal bone loss surrounding the implants comparing to the normal drilling techniques using the conventional implant drilling kit

Eligibility criteria: Inclusion Criteria:

* Patients with partially edentulous in the posterior area of the maxilla, with a residual ridge that allowed insertion of ≤3.5 width implants.
* Both sexes.
* No intraoral soft and hard tissue pathology
* No systemic condition that contraindicate implant placement

Exclusion Criteria:

* Sinus pathology.
* Heavy smokers more than 20 cigarettes per day.
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems
* Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site
* Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.

Primary outcomes:
measure: implant stability
timeFrame: at the time of surgery
Secondary outcomes:
measure: Marginal bone loss
timeFrame: 3 month
Other outcomes:
measure: patient satisfaction
timeFrame: 3 month
Locations:
Study officials:
References:
Clinical trial NCT04491149: Study on the Ability of Virtual Reality Glasses in Anxiety and Pain Reduction in 50 Women Undergoing Amniocentesis or Feticide
Official title: The Ability of Virtual Reality in Anxiety and Pain Reduction in Women Undergoing Amniocentesis or Feticide
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Acute
Amniocentesis
Foeticide
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-07-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Both amniocenteses and especially feticide are procedures that incorporate both anxiety and pain. As anxiety and pain can be reduced when using a distraction, The investigators speculate that the use of virtual reality glasses during these procedures will elevate both anxiety and pain.

The investigators will examine this hypothesis by comparing two groups of participants who undergo amniocentesis or feticide, one group will undergo the procedure while using virtual reality glasses and the other without the use of the glasses.


Eligibility criteria: Inclusion Criteria: Pregnant women undergoing amniocentesis/foeticide who will sign an informed consent form

-

Exclusion Criteria:

* Women younger than 18 years
* Twin pregnancies
* Women with vertigo

Primary outcomes:
measure: Anxiety level
timeFrame: Up to one hour before the procedure
measure: Anxiety level
timeFrame: Up to one hour after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: Asaf ha Rofeh, MC
Study officials:
References:
Clinical trial NCT02551549: An Ascending Multiple Dose Study of CD101 IV in Healthy Subjects
Official title: A Phase 1, Randomized, Double-Blind, Multiple-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD101 Injection in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Subjects
Lead sponsor: Cidara Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CD101 Injection in Healthy Subjects.

Detailed description: This is a Phase 1, single-center, prospective, randomized, double-blind study of multiple ascending doses (MAD) of CD101 Injection administered IV to healthy adult subjects. In this study, subjects in 3 cohorts of 8 subjects each will be randomized to receive multiple IV doses of CD101 Injection or placebo infusions. Dose levels of CD101 Injection to be assessed will follow an ascending multiple-dose regimen.

Eligibility criteria: Inclusion Criteria:

* Men must be surgically sterilized or using contraception,
* No significant findings on physical exam, ECG, clinical laboratory tests,
* Body mass index (BMI) between 18.5 and 32.0 kg/m2, inclusive
* Must provide written informed consent

Exclusion Criteria:

* Females of child bearing potential
* Signs and or symptoms of acute illness or chronic disease
* Use of prescription medications within 28 days
* Use of OTC, supplements, and herbals within 14 days
* Current smoker
* Previous participation in a clinical study within 28 days

Primary outcomes:
measure: Safety as assessed by the number of subjects with clinically significant adverse events
timeFrame: Up to 2 weeks following last dose of study drug
Secondary outcomes:
measure: Peak plasma concentration (Cmax)
timeFrame: Up to 2 weeks following last dose of study drug
measure: Time to reach peak plasma concentration (Tmax)
timeFrame: Up to 2 weeks following last dose of study drug
measure: Area under the concentration time curve (AUC)
timeFrame: Up to 2 weeks following last dose of study drug
measure: The volume of plasma cleared of the drug per unit time (CL)
timeFrame: Up to 2 weeks following last dose of study drug
measure: Apparent volume in which the drug is distributed (Vz)
timeFrame: Up to 2 weeks following last dose of study drug
measure: The rate at which a drug is removed from the body (^z),
timeFrame: Up to 2 weeks following last dose of study drug
measure: Terminal half-life (t1/2)
timeFrame: Up to 2 weeks following last dose of study drug
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion Inc
state: Arizona
Study officials:
affiliation: Celerion
name: Danielle Armas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00604149: Cardiac AResT And GENEtic
Official title: Etude Multicentrique en Population de la susceptibilité génétique à Faire Une Mort Subite
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Out-of-hospital Cardiac Arrest
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2008-01-30
Enrollment: 2332
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all subjects in out-of-hospital cardiac arrest and treated by medical mobil emergency medical care

Brief summary: Sudden death is a major problem in industrially developed countries. Despite a decline in ischemic heart disease mortality and the progress has been made in resuscitation, treatment of sudden death victims is frequently unsuccessful. the ideal solution would be to prevent the disease process that causes the initial episode of cardiac arrest. Parental sudden death is an independent risk factor for sudden death. So, detect a gene predisposing to sudden death may help provide better identification of subjects at high risk of cardiac arrest. This research is a genetic study of sudden cardiac death, recruited 2000 subjects in out-of-hospital cardiac arrest.


Eligibility criteria: Inclusion Criteria:

* OHCA
* Aged from 18 to 75 years

Exclusion Criteria:

* Pregnant
* People not free
* Inhospital subjects
* Death by other disease
* Violent death

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Xavier Jouven, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02823249: Effect of Amino Acids and Sugar Alcohols on Satiation Peptides and Activation of Specific Brain Regions
Official title: Effect of Amino Acids and Sugar Alcohols on Release of Satiation Peptides and Activation of Specific Brain Regions in Normal Weight and Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endocrine System Diseases
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: With this study the investigators investigate the effects of amino acids (tryptophan, leucin) and sugar alcohols (xylitol, erythritol) on satiety mechanisms and brain activation.


Eligibility criteria: Inclusion Criteria:

* Healthy normal weight subjects with a body-mass index of 19.0-24.9
* Healthy obese subjects with a body-mass index of \> 30
* Normal eating habits (no diets; no dietary changes; no special dietary habits such as vegetarian/vegan)
* Age 18-40 years
* Stable body weight for at least three months

Exclusion Criteria:

* Smoking
* Substance abuse
* Regular intake of medications (except for oral contraceptives)
* Medical or psychiatric illness
* History of gastrointestinal disorders
* Food allergies
* Pregnancy, breast feeding
* Body piercings that cannot be removed
* History of claustrophobia
* Left-hander

Primary outcomes:
measure: Effect of aminoacids on cerebral blood flow measured by functional brain MRI
timeFrame: changes from baseline to one hour after treatment
measure: Effect of sugar alcohols on cerebral blood flow measured by functional brain MRI
timeFrame: changes from baseline to one hour after treatment
Secondary outcomes:
measure: Measurement of Plasma Glucose concentrations
timeFrame: changes from baseline to three hours after treatment
measure: Measurement of Plasma Insulin concentrations
timeFrame: changes from baseline to three hours after treatment
measure: Measurement of Plasma cholecystokinin concentrations
timeFrame: changes from baseline to three hours after treatment
measure: Measurement of Plasma Glucagon-like Peptide (GLP-1) concentrations
timeFrame: changes from baseline to three hours after treatment
measure: Measurement of Plasma PYY concentrations
timeFrame: changes from baseline to three hours after treatment
measure: Measurement of Plasma ghrelin concentrations
timeFrame: changes from baseline to three hours after treatment
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel-Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Christoph Beglinger, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT05212649: Optimized Peak VO2 in Predicting Advanced HF
Official title: Optimizing Risk Stratification in Predicting Poor Prognosis in Post-Acute Heart Failure With Reduced Ejection Fraction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Morality
Transplant; Failure, Heart
Keywords: advance heart failure
cardiac transplantation
Peak oxygen consumption
Guideline-directed medical therapy
Risk score
Heart Failure Survival Score
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 377
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Investigators retrospectively collected acute HF patients discharged alive from the hospital. Investigators divided participants into more-GDMT (\>= 2 kinds) and few-GDMT (\<2 kinds) groups and compared the prognostic significance of peak VO2 and Heart Failure Survival Score for combined all-cause mortality and urgent cardiac transplantation.

Brief summary: The ability and timely selection of severe heart failure (HF) patients for cardiac transplantation and advanced HF therapy is challenging. Peak VO2 by cardiopulmonary exercise test (CPET) was used for transplant listing. This study aimed to reassess the prognostic significance of peak VO2 and to compare that with the Heart Failure Survival Score in the current optimized novel guideline-directed medical therapy (GDMT).

Detailed description: Investigators retrospectively collected acute HF patients discharged alive from the hospital. Investigators divided participants into more-GDMT (≥2 kinds) and few-GDMT (\<2 kinds) groups and compared the prognostic significance of peak VO2 and HFSS for combined all-cause mortality and urgent cardiac transplantation.

Eligibility criteria: Inclusion Criteria:

* acute HF patients with reduced ejection fraction (left ventricular ejection fraction, LVEF \<=40%) and discharged alive from the hospital
* patients with age \>= 20 years of age
* patients who performed cardiopulmonary exercise test (CPET) within one month after discharge
* patients with serum B-type natriuretic peptide (BNP) level \>100 pg/mL.

Exclusion Criteria:

* patients with estimated survival time \< 6 months
* patients who could not tolerate exercise test due to muscular-skeletal disorder or other reason
* patients who had severe valvular heart disease.

Primary outcomes:
measure: all-cause mortality
timeFrame: May, 2014 ~ June 2020
measure: urgent heart transplant
timeFrame: May, 2014 ~ June 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital Heart Failure Center
Study officials:
affiliation: Chang Gung Medical Foundation
name: Shyh-Ming Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02043249: Cord Milking and Activity Of The Immune System In Preterm Infants
Official title: Cord Milking and Activity Of The Immune System In Preterm Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Delivery
Keywords: DELAYED CORD CLAMPING
MILKING OF CORD
PREMATURE INFANTS
LEVEL OF IgG IN NEONATES
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-01-23
Enrollment: 200
Sex: ALL
Minimum age (years): 24
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In the embry life there is a passage of IgG type, from the mother to tha embryoyo and only in the age of 3-5 month after birth the infant start to develop them by himself.

In preterm infants the starting point of the level of the IgG's is lower from the level of term infants.

Delayed cord clamping /milking it was prooved in many researches as benificial in terms of : levels of hemoglobin; hematocrit and feritin in the neonats. Also benefits were proved by means of less need for blood tranfusion, less intra ventricular hemorrhage; necrotzing entero colitis and iron deficiency anemia. The hypothesis is that delayed clamping /milking it will increse the level of IgG's in preterm infants. The end point hypothesis is that delayed cord clamping /milking cause to less fever disease or hospitalization it the neonats.

Detailed description: In this study we come to a prove that if we miking the cord in preterm infats we will increse the level of IgG .

Eligibility criteria: Inclusion Criteria:

* PRETERM INFANS BETWEEN 24+0/7 TO 36

  * 6/7 WEEKS.
  * NEWBORN FOR MOTHER WHO AGREE TO PARTICIPATE IN THE RESEARCH WHO DELIVER IN NORMAL DELIVERY / PLANED OR URGENT CESARIAN DELIVERY

Exclusion Criteria:

* INTRA UTERINE GROWTH RESTRICTION, INFANT UNDER 10% TO AGE OF PREGNANCY.
* MOTHER WHO IS NOT WILLING TO PARTICIPATE IN RESEARCH.
* NEONATES TO MOTHER WHOM SUSPECTED TO BE IMMUNO- COMPROMISED OR HAVING INFECTION AROUND DELIVERY.

Primary outcomes:
measure: levels of IgG in preterm infats
timeFrame: 24 hours after delivery and after 24 hours..
Secondary outcomes:
measure: Mother's telephone questioning about the infant disease: fiver / hospitalization/tretment wit antibiotic.
timeFrame: 3 and 6 month after delivery
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hellel Yaffe Medical Center
name: Rivka Frenkel, MD
role: PRINCIPAL_INVESTIGATOR
References: