louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01603654: Sodium Picosulphate/Magnesium Citrate and Low-volume PEG -Ascorbic Acid as Preparation for Colonoscopy
Official title: A Randomized Controlled Trial Comparing the Efficacy and Acceptability of Sodium Picosulphate/Magnesium Citrate With Low-volume PEG -Ascorbic Acid as Preparation for Colonoscopy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colon Cleansing for Colonoscopy
Keywords: Colon preparation
Colonoscopy
Polyethylene glycol
Sodium Picosulphate
Lead sponsor: ASST Fatebenefratelli Sacco
Sponsor class: OTHER
First posted: 2012-05-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adequate bowel cleansing is essential for effective colonoscopy. Acceptance of colon preparation affects the quality of colon cleansing. The study is aimed at comparing the efficacy, safety and acceptability of sodium picosulphate/magnesium citrate (PMC) and low-volume PEG -ascorbic acid (PEG+ASC)in colon cleansing, and to identify predictors of poor bowel preparation.


Eligibility criteria: Inclusion Criteria:

* adult outpatients
* aged 18-85 years
* undergoing elective colonoscopy

Exclusion Criteria:

* previous colon resection
* ileus
* intestinal obstruction
* toxic megacolon
* severe heart failure (New York Heart Association \[NYHA\] Class III or IV)
* acute cardiovascular disease
* uncontrolled arterial hypertension (systolic pressure \> 170 mmHg, diastolic pressure \> 100 mmHg)
* severe liver failure or ascites
* end-stage renal failure
* phenylketonuria
* glucose-6-phosphate dehydrogenase deficiency. Women were excluded from the study if they were pregnant, breastfeeding

Primary outcomes:
measure: Efficacy of bowel cleansing
timeFrame: Within 24 hrs
Secondary outcomes:
measure: Safety
timeFrame: In the 24 hours within assumption of study products
measure: Tolerability
timeFrame: Within 12 hrs
Other outcomes:
Locations:
city: Como
country: Italy
facility: Ospedale Valduce, Gastroenterologia
city: Milano
country: Italy
facility: Ospedale S. Paolo
city: Milano
country: Italy
facility: Ospedale L. Sacco, Endoscopic Unit
Study officials:
affiliation: Ospedale L. Sacco
name: Gianpiero Manes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04246554: Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery
Official title: Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ACL Injury
Postoperative Pain
Keywords: ACL reconstruction
Ketorolac
Pain
Narcotic
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 49
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: TREATMENT

Brief summary: 1. The investigators aim to examine the use of IV and oral ketorolac as an adjunctive agent to the standard of care pain protocol for postoperative pain control following ACL reconstruction surgery.
2. The investigators hypothesize that the use of IV and oral ketorolac in addition to the standard of care pain protocol will reduce postoperative opioid consumption following ACL reconstruction surgery.


Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 89 years old
* Patients undergoing primary anterior cruciate ligament (ACL) reconstruction surgery

Exclusion Criteria:

* Patients below age 18 or above age 89
* Illiterate or non-English speaking individuals
* Patients with contraindications to Ketorolac
* History of chronic alcohol or drug abuse
* Chronic use of psychotropic or analgesic drugs
* Known peptic ulcer disease or bleeding diasthesis
* Renal dysfunction (estimated glomerular filtration rate \< 50 mL/min/1.73m2)
* Breastfeeding women
* Pregnant women

Primary outcomes:
measure: Postoperative Visual Analogue Scale Scores
timeFrame: Up to 8 weeks postoperative
Secondary outcomes:
measure: Narcotic Medication
timeFrame: 5 days
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: UH Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospital Cleveland Medical Center
name: Michael Karns, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06579833: Histotripsy (HistoSonics®) for Liver Tumours
Official title: Histotripsy (HistoSonics®) for Liver Tumours: a Phase II Safety and Efficacy Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Liver Tumour
Keywords: liver tumour
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Histotripsy is a promising non-invasive technique that uses high-intensity ultrasound waves to disrupt tissue without damaging surrounding structures. It works by using high-intensity ultrasound waves to create microscopic bubbles within the tumour tissue. These bubbles rapidly expand and collapse, generating shock waves that disrupt the tissue. The technique is highly precise and can be targeted to specific areas of the liver, allowing for selective destruction of tumour cells while minimizing damage to healthy tissue. This study will enrol 20 patients with liver tumours (be it primary or secondary liver tumours), monitor their post-operative adverse events, and study the changes in tumour size and volume after treatment. Histotripsy will be performed under general anaesthesia, with real-time monitoring by ultrasound, and deliver high-intensity ultrasound waves in single session or multiple sessions. Similar to other minimal invasive treatments, patients will be admitted 1 day prior, then receive Histotripsy on the next day and stay overnight for observation. Patients will be discharged on the 3rd day if unremarkable. During the hospital stay, blood samplings will be taken for evaluation around 2-4 times in total depending on the length of hospital stay.


Eligibility criteria: Inclusion Criteria:

* Fit for general anaesthesia
* Liver tumour size \< 10cm
* Solitary or multifocal
* Primary liver tumour such as hepatocellular carcinoma or intrahepatic cholangiocarcinoma
* Secondary liver tumour such as liver metastasis
* Patients with operable or inoperable liver tumours
* Liver transplant candidates awaiting for liver graft

Exclusion Criteria:

* Refusal to take part in clinical trial
* Child C liver cirrhosis
* Not fit for general anaesthesia

Primary outcomes:
measure: Changes in tumour features
timeFrame: up to 36 months
measure: Post procedure adverse events and complication
timeFrame: The whole duration of hospital stay, normally 3 days on average
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Albert Chan, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05112133: Effect of Mulberry Leaf Extract on Glucose Response of a Test Meal
Official title: Effect of Mulberry Leaf Extract on Glucose Response of a Test Meal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-prandial Glycemia
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2021-11-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to test the effects of Mulberry leaf extract on glucose response of a standardized complete meal when taken just before or when mixed with the meal.


Eligibility criteria: Inclusion Criteria:

* Male and female participants
* Healthy status (based on anamnesis)
* Age between 18 and 45 years
* BMI between 20 and 29.9 kg/m2
* Ability to understand and sign an informed consent form

Exclusion Criteria:

* Pregnant or lactating women
* Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments
* Known food allergy and intolerance to test product
* Medically known cutaneous hypersensitivity to adhesives and plasters
* Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.

Smokers

Volunteer who cannot be expected to comply with the protocol

Subject having a hierarchical link with the research team members.

Primary outcomes:
measure: Post-prandial glucose
timeFrame: Hour 0 to hour 3 after standard meal consumption
Secondary outcomes:
measure: C max glucose
timeFrame: Hour 0 to hour 3 after standard meal consumption
measure: T max glucose
timeFrame: Hour 0 to hour 3 after standard meal consumption
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Nestlé Clinical Research Unit
state: Vaud
Study officials:
References:
Clinical trial NCT01906333: Elevated FFA and Skeletal Muscle Lipid Content
Official title: Effects of Acute Elevation of Circulating Fatty Acids on Skeletal Muscle Lipid Accumulation and Metabolism in Healthy Lean Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Exercise Physiology
Keywords: Exercise
Ectopic fat accumulation
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2013-07-24
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: There is increasing evidence that skeletal muscle lipid content (IntraMyoCellular Lipid, IMCL) markedly increases the risk of metabolic complications, including insulin resistance and cardiovascular events. The investigator hypothesizes that skeletal muscle is passively taking up FFAs when the availability is high, thereby leading to an increased storage. To test this hypothesis, the investigator wants to manipulate FFA levels, by means of exercise, and monitor intramuscular lipid content.

Therefore the objective is to examine the effect of an exercise-induced elevation of FFA on skeletal muscle lipid content in healthy lean men. To this end, skeletal muscle lipid content will be investigated at baseline and after an exercise protocol and again after a four-hour recovery period from exercise, once in a condition with high FFA concentration, once with low FFA concentration. To achieve high- versus low FFA concentrations, an exercise protocol was chosen and participants had to perform this protocol once with a glucose supplementation and once without.

Skeletal muscle lipid content will be determined before, directly after exercise and 4 h post exercise (from muscle biopsies) with or without glucose supplementation.


Eligibility criteria: Inclusion Criteria:

* Male sex
* Age 18-30 years
* Lean, BMI 18-25 kg/m2
* Healthy
* Stable dietary habits
* No medication use

Exclusion Criteria:

* Female sex
* Engagement in programmed exercise \> 2 hours total per week
* Cardiac problems, such as angina pectoris, cardiac infarction and arrhythmias
* First degree relatives with type 2 diabetes mellitus
* Any medical condition requiring treatment and/or medication use
* Unstable body weight (weight gain or loss \> 3 kg in the past three months)
* Participation in other biomedical study within 1 month prior to the screening visit
* Subjetcs, who do not want to be informed about unexpected medical findings, or do not wish that their treating physician is informed, cannot participate in the study

Primary outcomes:
measure: Change in IntraMyoCellularLipid (IMCL)content
timeFrame: Baseline, directly postexercise and 4 hours post-exercise
Secondary outcomes:
measure: Change in substrate metabolism
timeFrame: Measured several time points during the test day
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Department of Human Biology, Maastricht University Medical Center (MUMC)
Study officials:
References:
Clinical trial NCT04901533: Cervical Manipulation (OAA Technique) in Exophories
Official title: Effect of Occipito-atlas-axis Manipulation on Oculomotricity in Individuals With Exophories
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exophoria
Keywords: cervical manipulation
disorder ocular motility
musculoeskeletal
strabismus
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 57
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objetive: to assess the efficacy of the occipito-atlas-axis cervical manipulation technique to correct ocular divergence in subjects with exophoria.

Design: quantitative, experimental, longitudinal and prospective study.

Subjects: subjects over 18 years of age, with exophorias, without heterotropies and who do not present a contraindication to cervical manipulation.

Methods:Subjects with this ocular mobility dysfunction are going to be evaluated objectively with the Alternate Cover Test. The ocular deviation will be measured at 40 cm and at 4 meters. The individuals who were part of the experimental group underwent the OAA manipulation technique, and to those who were part of the control group a placebo maneuver. Two measurements were taken from this moment, one immediately after the execution of the technique and another one week later.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of exophoria
* Being 18 years old.

Exclusion Criteria:

* Having heterotropia or have been treated for it.
* Present contraindication to manipulation (recent fractures, sprains, or dislocations, local tumor, rheumatic polyarthritis, Down syndrome, vertebrobasilar insufficiency, basilar impression, refusal to be manipulated).
* Having cervical manipulation before two weeks.

Primary outcomes:
measure: exophoria with cover test at 40 cm
timeFrame: Changes from baseline to moment after intervention
measure: exophoria with cover test al 4 m
timeFrame: Changes from baseline to moment after intervention
Secondary outcomes:
measure: exophoria with cover test at 40 cm (2)
timeFrame: Changes from baseline to 1 week after intervention
measure: exophoria with cover test al 4 m (2)
timeFrame: Changes from baseline to 1 week after intervention
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Lourdes M Fernández-Seguín
Study officials:
affiliation: University of Seville
name: Lourdes M Fernández-Seguín, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05070533: Interventions to Prevent Falls. PRECAISAL Study
Official title: Interventions to Prevent Falls in Elderly People Who Live at Home. PRECAISAL Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Accidental Falls
Old Age; Debility
Activity, Motor
Lead sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Sponsor class: OTHER
First posted: 2021-10-07
Enrollment: 0
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to guide older people living in the community on appropriate strategies within a fall prevention program. This program is aimed at training in physical exercises carried out through group workshops or at preventing risk situations at home.

Detailed description: Two-arm, non-blind, non-inferiority experimental design. Multicenter, randomized trial.

The study tries to assess whether a group intervention following the principles of the LiFE program is no less effective than individual intervention in reducing the incidence of falls.

Eligibility criteria: Inclusion Criteria:

* Older than 70 years
* Live at your address
* Are at risk of falls
* Timed Up and Go Test time timed ≥ 12 seconds
* Able to walk 200 meters without personal assistance
* Speak and read in Spanish

Exclusion Criteria:

* Perform moderate to vigorous physical activity\> 150 min / week in the last 3 months
* Present any of the following medical conditions:

  * Heart failure (New York Heart Association class III and IV)
  * Recent stroke (\<6 months)
  * Parkinson's disease
  * In active cancer treatment (last 6 months)
  * Class III and IV chronic obstructive pulmonary disease
  * Unstable fracture of the lower limb
  * Lower limb amputated
  * Treatment for less than 6 months of depression
  * Uncontrolled resting blood pressure of a systolic pressure\> 160 or a diastolic pressure\> 100 or more
  * Not being available for home visits within 11 weeks of the initial assessment: having planned trips or transfers of more than 2 months within the first 6 months of the study
  * Moderate to severe cognitive impairment (Mini Mental cognitive assessment \<23)
  * Current participation in another scientific intervention trial.

Primary outcomes:
measure: Incidence of falls
timeFrame: 6 months
measure: Physical activity
timeFrame: 9 days
measure: Cost-effectiveness
timeFrame: 6 months
measure: Health effects
timeFrame: 6 months
Secondary outcomes:
measure: Fear of falling
timeFrame: 6 months
measure: Adherence to exercise
timeFrame: 6 months
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Infosalud
Study officials:
affiliation: Primary Health Care Research Unit
name: Luis García-Ortiz
role: STUDY_CHAIR
References:
Clinical trial NCT05940233: Comparison of Rate of Complete Abortion Between Letrozole Plus Misoprostol vs Misoprostol Alone
Official title: Comparison of Rate of Complete Abortion Between Letrozole Plus Misoprostol vs Misoprostol Alone in First Trimester Pregnancy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Medical; Abortion, Fetus
Lead sponsor: Queen Savang Vadhana Memorial Hospital, Thailand
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 70
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: We devide patient into 2 groups, intervention and control group. In intervention group we give the Letrozole 10 mg PO daily at day 1-3 prior to Misoprostol 800 mcg SL in day 4.

In control group we give only Misoprostol 800 mcg SL.
Primary purpose: TREATMENT

Brief summary: Comparison of rate of complete abortion between Letrozole plus Misoprostol versus Misoprostol alone in first trimester pregnancy

Detailed description: Comparison of rate of complete abortion between Letrozole plus Misoprostol versus Misoprostol alone in first trimester pregnancy; RCT

This reseach focus on the medical abortion in the early pregnancy loss. The target population is 70 patients (35 per group). We devide patient into 2 groups, intervention and control group. In intervention group we give the Letrozole 10 mg PO daily at day 1-3 prior to Misoprostol 800 mcg SL in day 4.

In control group we give only Misoprostol 800 mcg SL. Then, thepatien will follow up on day 7, TVS will be done to diagnose the complete abortion.

The primary outcome is rate of complete abortion between 2 groups. The secondary outcome is side effect of letrozole and induced to abortion time.

Eligibility criteria: Inclusion Criteria:

* Diafnoed Early pregnancy loss by TVS according to ACOG Practice bulletin 2018
* GA \<= 14 weeks
* Os open \<= 1 cm and no conceptus per os
* Hematicrit \>= 30
* Systolic blood pressure \>= 95 mmHg
* Informed consent done and can follow up and comunicate in Thai language

Exclusion Criteria:

* Allerguc to Letrozole or Misoprostol
* Intrauterine contraceptive device use
* Breast feeding
* Diagnoed with ectopic pregnancy or undiagnoed adnexal mass
* Severe or recurrent liver disease or AST or ALT more than or equal to 3 times of upper normal limit
* Multiple pregnancy
* Myoma uteri that involves the endometrium ex. Submucous myoma uteri
* Thromboembolism or has a history of thromboembolism
* Serum creatinine \>= 2

Primary outcomes:
measure: Rate of complete abortion
timeFrame: up to 7 days
Secondary outcomes:
measure: Side effect between both group
timeFrame: up to 7 days
measure: induced to abortion time between both group
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Sutinee Srimahachota
state: Yannawa
Study officials:
affiliation: Queen Savang Vadhana Memorial Hospital, Thailand
name: ชื่นฤทัย ยี่เขียน, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05422833: Effectiveness of Medical Management of Fibrous Dysplasia of Bone.
Official title: Effectiveness of Medical Management in the Field of Rare Diseases. The Example of Fibrous Dysplasia of Bone.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibrous Dysplasia of Bone
McCune Albright Syndrome
Keywords: Fibrous Dysplasia of Bone
McCune Albright Syndrome
rare
bone disease
healthcare organization
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 528
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adults with FD/MAS who visited at least once in our center

Brief summary: The objective of our study was to assess the effectiveness of our reference center since its constitution.

In a retrospective cohort study, we compared the activity of our center, including the time elapsed between diagnosis and access to the center and the diagnostic delay of patients with fibrous dysplasia between two periods, 1996-2006 (before certification of our center) and 2007-2019 (after certification of our center).


Eligibility criteria: Inclusion Criteria:

We have included children and adults with FD/MAS who visited at least once in our center (outpatient and hospitalized patients). The diagnosis was established by an expert of the center, based on clinical, biological, imaging and/or histological arguments

Exclusion Criteria:

The absence of detectable bone lesion

Primary outcomes:
measure: to compare time elapsed between first symptomes or discovery of bone lesions and the diagnosis of FD
timeFrame: 1996-2019
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: rheumatology department, hopital Edouard Herriot
Study officials:
References: