louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06459323: the Outcomes of Laparoscopic Cholecystectomy for Acute Cholecystitis Within and Beyond the First 72 Hours, Does it Differ?!
Official title: the Outcomes of Laparoscopic Cholecystectomy for Acute Cholecystitis Within and Beyond the First 72 Hours, Does it Differ?!
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Cholecystitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare outcomes of patients undergoing early laparoscopic cholecystectomy within and after72 hours of symptoms.

Detailed description: Laparoscopic cholecystectomy (LC) is the mainstay treatment of acute cholecystitis. However, it remains a challenging procedure with low but significant risks of major complications such as bile duct injury increasing as the severity of AC progresses. New Guidelines suggest that laparoscopic cholecystectomy should preferably be performed within 72 hrs of symptom onset but has acknowledged that this may not be always possible in practice. Hence, it recommends that patients presenting after 72 h of symptom onset may still benefit from laparoscopic cholecystectomy in selected patients Studies found that it is imperative to convert to open cholecystectomy when it is deemed unsafe to dissect the Calot's triangle may occur even within or beyond first 72 hrs of attck symptoms. studies found a statistically longer mean total length of hospitalization, operation time and intraoperative blood loss for LC performed beyond 72 h, this did not translate into clinically significant adverse outcomes such as an increase in perioperative morbidity or the need for blood transfusion. After 72 h, chronic inflammation and fibrosis set in resulting in more technically demanding and longer surgeries.Studies show differing results reporting longer operation times for laparoscopic cholecystectomy beyond 72 h, due to stiffer tissues that cannot be bluntly dissected during the subacute phase of tissue inflammation. However, other studies did not report any difference in operation times between both groups.

Eligibility criteria: Inclusion Criteria:

1. Patients with acute cholecystitis within and after 72 hours.
2. Patients over 18 years.
3. Patients with no common bile duct stones based on imaging and biochemical criteria
4. Fit for surgery.

Exclusion Criteria:

1. Patients not fit for surgery
2. Patients with Pancreatitis.
3. Significant medical disease rendering patient unfit for Laparoscopic surgery (e.g. Uncontrolled Diabetes Mellitus, Chronic Pulmonary Disease, significant Cardiac Disease)

Primary outcomes:
measure: Bile duct injury , intraoperative bleeding and operative time
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04120623: Therapeutic Effect of Dapagliflozin Combined With CSII on Newly Diagnosed Type 2 Diabetes Mellitus
Official title: Therapeutic Effect of Dapagliflozin Combined With CSII on Newly Diagnosed Type 2 Diabetes Mellitus With Continuous Glucose Monitoring System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Continuous Glucose Monitoring System (CGMS)
Dapagliflozin
Continuous Subcutaneous Insulin Infusion ( CSII)
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effect of dapagliflozin combined with CSII and CSII alone on glucose profile in newly diagnosed type 2 diabetes mellitus by continuous glucose monitoring system.

Detailed description: To compare the effect of dapagliflozin combined with continuous subcutaneous insulin infusion (CSII) and CSII alone on glucose profile in newly diagnosed type 2 diabetes mellitus by continuous glucose monitoring system.

Eligibility criteria: Inclusion Criteria:

* volunteer to participate and be able to sign informed consent prior to the trial.
* patients with type 2 diabetes or type 1 diabetes, aged 18-80 years old.
* No acute complications such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc.
* Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise.

Exclusion Criteria:

* Patients with insulin allergy.
* Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value; Serum creatinine was 1.3 times higher than the upper limit of normal.
* Drug abuse and alcohol dependence in the past 5 years.
* Systemic hormone therapy was used in the last three months.
* Patients with poor compliance and irregular diet and exercise.
* Patients with pregnancy, lactation or pregnancy intention.
* Any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.

Primary outcomes:
measure: the effect of dapagliflozin combined with CSII on glucose profile
timeFrame: 5 weeks
Secondary outcomes:
measure: the effects of dapagliflozin combined with CSII on weight
timeFrame: 5 weeks
measure: the effects of dapagliflozin combined with CSII on blood pressure
timeFrame: 5 weeks
measure: the effects of dapagliflozin combined with CSII on lipid metabolism(total cholesterol in mmol/l, total glyceride in mmol/l)
timeFrame: 5 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Nanjing First Hospital, Affiliated to Nanjing Medical University
name: Jianhua Ma
role: STUDY_DIRECTOR
References:
Clinical trial NCT05453123: The Effect of Motivational Messages by "WhatsApp" on Adherence to Home Exercise Program
Official title: The Effect of Motivational Messages by "WhatsApp" on Adherence to Home Exercise Program Among Middle-aged and Older Adults With Knee Osteoarthritis in Saudi Arabia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 42
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to examine the effect of the text message platform (WhatsApp) on the adherence to home exercise programs, pain and physical function among middle age and older adults with knee OA in two public hospitals in Riyadh city, Saudi Arabia


Eligibility criteria: Inclusion Criteria:

Saudi adults aged 45 to 65. Diagnosis of unilateral or bilateral, mild to moderate knee OA

Exclusion Criteria:

Diagnosis of severe knee OA Diagnosis of neurological conditions Diagnosis of cardiopulmonary conditions Diagnosis of mental disorders on wait for surgical intervention.

Primary outcomes:
measure: Adherence percentage outcome was measured with the self-report
timeFrame: baseline and see the change after 6 weeks
Secondary outcomes:
measure: VAS
timeFrame: baseline and see the change after 6 weeks
measure: WOMAC
timeFrame: baseline and see the change after 6 weeks
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
References:
citation: Eickenberg H-U. Letter: Hypoazotemia. Urology. 1975 Aug;6(2):267. doi: 10.1016/0090-4295(75)90734-7. No abstract available.
citation: Al-Arfaj AS, Al-Boukai A. Prevalence of radiographic osteoarthritis of the hands in Saudi Arabia. Rheumatol Int. 2002 Sep;22(5):208-12. doi: 10.1007/s00296-002-0228-5. Epub 2002 Aug 13.
Clinical trial NCT02895438: Non Coeliac Gluten Sensitivity in Children
Official title: Does Non Coeliac Gluten Sensitivity (NCGS) Exist in Children? A Double-Blind Randomized Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Gluten-Free
Gluten-Sensitive Enteropathy
Keywords: Gluten-Sensitive
Diet, Gluten-Free
Irritable Bowel Syndrome
non Coeliac Gluten sensitivity
children
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Irritable Bowel syndrome (IBS) is a very frequent condition in children. Its management is difficult, often resulting in a persistence of chronical abdominal pain.

In adults, many patients affected by IBS improve under a gluten-free diet, even in the absence of Celiac Disease (CD) or wheat allergy. This condition is called Non Coeliac Gluten Sensitivity (NCGS). However, it is still not clear how to diagnose and manage NCGS, and the pathophysiological mechanisms also remain elusive.

The aim of this study is to determine if NCGS exists in children with IBS and to identify the clinical, serological, and histological characteristics, which could distinguish patients with NCGS from conventional IBS and CD patients.

This is a prospective cohort study in a population of children affected by a moderate to severe IBS for more than 6 months. All children had a Gluten Free Diet (GFD) for 6 weeks. Then, children who improved under GFD were randomized in two groups for a double-blind placebo-controled trial. One group had a reintroduction of gluten followed by a wash-out period, then a placebo reintroduction, whereas the other group had the placebo first, then the wash-out and the gluten reintroduction.


Eligibility criteria: Inclusion Criteria:

* children with Irritable Bowel Syndrome (IBS)

Exclusion Criteria:

* children with Celiac Disease (CD)
* children with wheat allergy

Primary outcomes:
measure: Severity of IBS
timeFrame: 12 weeks after randomisation
Secondary outcomes:
measure: change in gastro-intestinal symptoms
timeFrame: 12 weeks after randomisation
measure: Change in quality of life
timeFrame: 12 weeks after randomisation
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Sylvie DESTOMBE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00412438: Investigation of Genetic Risk of Atrial Fibrillation
Official title: Investigation of Genetic Risk of Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Lead sponsor: Nagoya University
Sponsor class: OTHER
First posted: 2006-12-18
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: The atrial fibrillation (AF) is the most common cardiac rhythm disturbance that is responsible for substantial morbidity and mortality independent of associated heart disease or other risk factors. Even in the absence of preexisting cardiovascular disease, AF remains significantly associated with excess mortality rates. The current unsatisfactory treatment for AF comes from lack of understanding of the pathophysiology of AF. The purpose of this study is to identify gene polymorphisms that confer susceptibility to atrial fibrillation. Patients with AF（N=500） and healthy volunteer（N=1000） without AF are enrolled in this study. Patients with coronary artery disease, severe valvular heart disease, cardiomyopathy or heart failure were excluded from the study.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of atrial fibirillation

Exclusion Criteria:

* coronary artery disease
* severe valvular heart disease
* cardiomyopathy
* heart failure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Department of Bio-information Analysis, Research Institute of Enviromental Medicine, Nagoya University
state: Aichi
Study officials:
affiliation: Department of Bio-information Analysis, Research Institute of Enviromental Medicine, Nagoya University
name: Kenji Yasui, MD, Phd
role: STUDY_CHAIR
References:
Clinical trial NCT06398938: Evaluation of Ultraaccelerated High Dose Rate Intrauterine Interventional Radiotherapy
Official title: EROS 3 Study Evaluation of Ultraaccelerated High Dose Rate Intrauterine Interventional Radiotherapy Brachytherapy in Terms of Overall Toxicity and Sexual Activity
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Locally Advanced Cervical Carcinoma
Keywords: cervical carcinoma
interventional radiotherapy
acute and late toxicities
radiochemotherapy
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 129
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with locally advanced cervix cancer

Brief summary: To evaluate the degree of acute and long-term intestinal, urinary and vaginal toxicity, and the impact on sexual activity of an accelerated fractionation of high dose rate interventional radiotherapy (IRT-HDR) in patients with locally advanced cervical cancer (IB2 - VA, N+/-).

Detailed description: Observational, monocentric and prospective study. All patients with locally advanced cervix cancer will be underwent to radiochemotherapy followed by accelerated interventional radiotherapy (brachytherapy). Fist endpoints wer severe acute and late gastrointestinal, and urinary toxicities and sexual activity.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* ECOG 0-2
* Histological diagnosis of squamous carcinoma and/or adenocarcinoma of the uterine cervix
* FIGO IB2 Stadium - IVA (staging 20018)
* No contraindications to performing MRI of the pelvis
* Informed consent

Exclusion Criteria:

* Age \<18 years
* PS \>2
* Previous cancer in the last 10 years
* Previous radiation treatment in the region of interest
* Presence of pathologies that contraindicate radiotherapy treatment (genetic syndromes of hyper-radiosensitivity, ulcerative colitis, diverticulitis in the acute phase, severe diverticulosis, chronic pelvic inflammation)
* Presence of internal diseases that contraindicate chemotherapy or radio-chemotherapy treatment (severe liver disease, heart disease, renal failure, etc.)
* Presence of distant metastases in sites other than the pelvic lymph nodes
* Any significant medical condition that in the opinion of the investigator may interfere with the patient's optimal participation in the study

Primary outcomes:
measure: Acute and late gastrointestinal toxicity
timeFrame: 6 months
measure: Acute and late urinary toxicity
timeFrame: 6 months
measure: Sexual activity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fondazione Universiataria Policlinico A Gemelli IRCCS
name: VALENTINA LANCELLOTTA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01158638: Utilizing Tailored Step-Count Feedback to Enhance Physical Activity in the Elderly
Official title: Utilizing Tailored Step-Count Feedback to Enhance Physical Activity in the Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Physical Activity
Elderly
Keywords: Physical Activity Enhancement
Lead sponsor: University of Wisconsin, Milwaukee
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2010-07-08
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Individually tailored, mediated pedometer feedback will provide an effective method to promote physical activity adoption in the elderly


Eligibility criteria: Inclusion Criteria:

1. Male or female individuals living in the community.
2. Aged between 50 and 85 years, at screening.
3. Sufficient physical function not to have limitations to participate in physical activity demonstrated by:

   * Habitual gait speed ≥ 1.5 mph, AND
   * No use of a cane or walker, AND
   * Able to walk ≥ 50 feet unaided
4. Sufficient cognitive function, as demonstrated by responses to the mini-mental state examination(\>23 score).
5. Be able to read and write in English
6. Sedentary behavior, demonstrated by no regular activity / exercise for previous 6 months and/or a Stage of Change 2 and 3

Exclusion Criteria:

1. Presence of a rapidly progressive or terminal illness condition that is expected to result in significant functional decline during the course of the proposed studies.
2. Significant uncontrolled cardiovascular disease and conditions, e.g. unstable or new onset angina, unrepaired aortic aneurysms, critical aortic stenosis or CAD without bypass, persistent moderate to severe uncontrolled hypertension.
3. Significant uncontrolled metabolic disease, e.g. hemoglobin A1c levels greater than 8.0 and/or glucose levels greater than 300 mg/dL.
4. Fracture of lower extremity within three months.
5. Amputation other than toes.
6. Current history of severe arthritis or orthopedic condition precluding physical activity.
7. Participation in any regular structured exercise (resistance training, Tai Chi, high intensity walking, jogging, cycling, stair climbing, stepping, within the previous 6 months.
8. Individuals that start a new medication that can impact health variables examined during study period (e.g., beta blockers, glucose or cholesterol altering medications), or individuals who alter medication dose that can impact health variables examined within study period.

Primary outcomes:
measure: Objectively assessed steps per day
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Physical Activity & Health Research Laboratory
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Milwaukee
name: Scott J Strath, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03336138: Application of Telemedicine to the Management of Aggressive Lymphomas
Official title: Application of Telemedicine to the Management of Aggressive Lymphomas: a Regional Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoma
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2017-11-08
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the value of AMA in a comparative multicenter regional study as a reference for aggressive lymphoma. The primary endpoint will be RDI. This study consider that the AMA support should allow a significant improvement of the RDI compared to the control group and thus impact the duration without progression. The study covers 350 patients recruited from 10 regional centers.


Eligibility criteria: Inclusion Criteria:

* Patient with a recent diffuse large B cell lymphoma (LBDGC), histologically proven, with treatment not started
* a priori likely to be treated by rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone every 21 days (R-CHOP21) for 8 cycles or rituximab, doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (R-ACVBP).
* Index international prognosis (IPI) measurable (IPI-aa), adjusted for age. Any IPI-aa is eligible.
* accepting the study

Exclusion Criteria:

* Patient with another type of lymphoma (including transformed follicular forms)
* Patient having already started his treatment.
* Life expectancy \<3 months.
* Carcinologic history
* Serum positive for HIV or hepatitis B virus (HBV).

Primary outcomes:
measure: dose-relative intensity (RDI)
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Albi
country: France
facility: Clinique Claude Bernard
city: Auch
country: France
facility: Hospital
city: Bayonne
country: France
facility: Bayonne Hospital
city: Bordeaux
country: France
facility: University Hospital Bordeaux
city: Montauban
country: France
facility: Hospital
city: Pau
country: France
facility: Clinique Marzet
city: Rodez
country: France
facility: Rodez Hospital
city: Tarbes
country: France
facility: Tarbes Hospital
city: Toulouse
country: France
facility: Clinique Saint Jean
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: LAURENT Guy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02857738: Sun Protection Factor (SPF) - Static and Water Resistant Assay
Official title: Sun Protection Factor (SPF) - Static and Water Resistant Assay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreen Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-08-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of human subjects.


Eligibility criteria: Inclusion Criteria:

* Male or female of an age of 18 to 70 years inclusive;
* Fitzpatrick Skin Type I, II and/or III for SPF testing;
* Good health as determined from the CRO Subject History Form (SHF);
* Signed and dated Informed Consent Form;
* Signed and dated Health Insurance Portability and Accountability Act (HIPAA) Form;
* An unambiguous minimal erythema dose (MED).

Primary outcomes:
measure: Evaluation of water resistant SPF in accordance to ISO 24444
timeFrame: 16-24 hrs post exposure
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: