louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05747352: Safety of Closed-loop Hybrid Insulin Administration During Ramadan Fasting in People Living With Type 1 Diabetes
Official title: Evaluation of the Glycemic Profile During the Ramadan Fasting in People With Type 1 Diabetes Treated With Closed-loop Hybrid Insulin System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type1diabetes
Keywords: type1diabetes
the Ramadan fasting period
closed-loop hybrid insulin administration
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with type 1 Diabetes

Brief summary: Fasting in Ramadan is not recommended for people with type 1 diabetes. The main risk associated with fasting is dysglycemia (hypoglycemia, hyperglycemia, diabetic ketosis) and dehydration. Nevertheless, whether or not to practice Ramadan remains a personal choice and many people living with diabetes choose to perform this fast with or without their physician's approval. The purpose of this prospective observational study is to evaluate the safety and efficacy of an closed-loop hybrid insulin system on glycemic parameters and the level of hypoglycemia in patients with type 1 diabetes who wished to fast during Ramadan.

Detailed description: Primary objective: to evaluate the efficacy of an closed-loop hybrid insulin system on continuous glucose monitoring (CGM) glycemic parameters during the Ramadan fasting period Primary endpoint : to compare the time spent in the 3.9-10.0 mmol/l glucose target (TIR) from 30 days prior to the Ramadan fasting period to 30 days during the fasting period

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* type 1 diabetes for \> 1 year
* on using closed-loop hybrid insulin administration
* scheduled Ramadan fasting
* patient put on using closed-loop hybrid insulin administration more than 2 months before the start of the Ramadan fast
* percentage of continuous glucose monitoring sensor wear \> 70% in at least one of the two 30-day periods

Exclusion Criteria:

* patient put on using closed-loop hybrid insulin administration less than 2 months before the start of the Ramadan fast
* patient who is pregnant or wants to become pregnant immediately
* patient informed of the study who objected to the collection of his/her data.

Primary outcomes:
measure: Glucose time
timeFrame: Day 30
Secondary outcomes:
measure: Glucose time
timeFrame: Day 60
measure: Glucose time
timeFrame: Day 30
measure: Glucose time
timeFrame: Day 60
Other outcomes:
Locations:
city: Corbeil-essonnes Cedex
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
affiliation: Centre Hospitalier Sud Francilien
name: Dured DARDARI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02143752: Meriter Mindfulness Training for Smokers Program and Study
Official title: Meriter Mindfulness Training for Smokers Program and Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Keywords: Smoking
Tobacco
Addiction
Mindfulness
Meditation
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2014-05-21
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study subjects will be drawn from the Meriter Smoking Cessation Program, which is made up of two interventions: the Mindfulness Training for Smokers (MTS) intervention and the Quit Line (QL) Intervention

Brief summary: The Meriter Smoking Cessation Study tests participants in the Meriter Smoking Cessation Program. Meriter Hospital and clinic patients will be recruited into the Meriter Smoking Cessation Program. The Meriter Smoking Cessation Program has two interventions, the Mindfulness Training for Smokers (MTS) intervention and the Quit Line (QL) Intervention. Study activities include one 10-minute study visit and two 5-minute survey phone calls.

Detailed description: The Meriter Smoking Cessation Study tests participants in the Meriter Smoking Cessation Program. Meriter Hospital and clinic patients will be recruited into the Meriter Smoking Cessation Program. The Meriter Smoking Cessation Program has two interventions, the Mindfulness Training for Smokers (MTS) intervention and the Quit Line (QL) Intervention. Study activities include one 10-minute study visit and two 5-minute survey phone calls.

MTS: Mindfulness Training for Smokers Intervention. This is the 7-week quit smoking intervention developed by the PI.

QL: Quit Line Intervention. This is a program starting at makes use of the Wisconsin Tobacco Quit Line.

Meriter Smoking Cessation Program: A program offering the MTS and QL interventions to smokers at Meriter Hospital and Clinics.

Meriter Smoking Cessation Study: This is a study comprised of 2 phone surveys and 1 study visit that tests participants in the MTS and QL intervention. Participants in the Meriter Smoking cessation program will have the opportunity to decide if they would like to be in the study.

Eligibility criteria: Inclusion Criteria:

* everyday smoker

Exclusion Criteria:

* current alcohol or other drug addiction

Primary outcomes:
measure: biochemically confirmed post treatment smoking abstinence
timeFrame: 10 days post quit
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Meriter Hospital and Medical Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: James M Davis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davis JM, Mills DM, Stankevitz KA, Manley AR, Majeskie MR, Smith SS. Pilot randomized trial on mindfulness training for smokers in young adult binge drinkers. BMC Complement Altern Med. 2013 Sep 3;13:215. doi: 10.1186/1472-6882-13-215.
Clinical trial NCT06246552: Clinical Trial to Evaluate the Safety and Efficacy of JTM201 to Treat Moderate or Severe Glabellar Lines
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled, Single-dose Phase 2 Study of the Safety and Efficacy of JTM201 (Botulinum Toxin Type A) to Treat Moderate or Severe Glabellar Lines
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Glabellar Lines
Lead sponsor: Jetema Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-07
Enrollment: 480
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 is Multicenter, Randomized, Double-blind, Placebo-controlled, Single-dose Study to evaluate Safety and Efficacy of JTM201 in patients with Moderate or Severe Glabellar Lines

Detailed description: This is Multicenter, Randomized, Double-blind, Placebo-controlled, Single-dose Study to evaluate Safety and Efficacy of JTM201 in patients with Moderate or Severe Glabellar Lines. Treatment period is 180 days and evaluation of the safety is the primary endpoint

Eligibility criteria: Inclusion Criteria:

* Subjects ≥18 years of age based on the date of the written informed consent form.
* Subject is able to provide written informed consent and comply with study procedures.
* Subject has moderate or severe glabellar lines on maximum frown as assessed by the investigator and subject using the GLS (score of 2 or 3).

Exclusion Criteria:

* Previous insertion of permanent material in the glabellar area including the forehead.
* Planned treatment with botulinum toxin of any serotype in any other body region during the study period.
* Pregnant or breastfeeding (directly or via pump); or planning to become pregnant during the study.
* Known allergy or hypersensitivity to botulinum toxin or product excipients.
* Participation in another interventional clinical study ≤30 days of Visit 1: Screening.
* Planning to donate, bank, or retrieve eggs (ova, oocytes) or donate sperm during the study.

Primary outcomes:
measure: TEAE
timeFrame: 180 days
measure: SAE
timeFrame: 180 days
Secondary outcomes:
Other outcomes:
measure: Glabellar Line Scale (GLS)
timeFrame: 30 days
Locations:
Study officials:
References:
Clinical trial NCT03812952: China Red Eye Study on Allergic Conjunctivitis
Official title: Current Status of Diagnosis and Treatment of Allergic Conjunctivitis in Chinese Ophthalmology Clinic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Allergic Conjunctivitis
Keywords: misdiagnose
mistreatment
antibiotics
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients whose clinical diagnosis is allergic conjunctivitis.

Brief summary: This study is the first multi-center cross-sectional study on the diagnosis and misdiagnosis of allergic conjunctivitis in the ophthalmology clinic in China. It provides a clinical basis for the standardized diagnosis and treatment of allergic eye diseases.

Detailed description: Allergic conjunctivitis is a common disease in ophthalmology. The European Allergy Association, Japan, the United States and other countries have clear diagnostic criteria or guidelines for the definition and diagnosis of allergic diseases and allergic conjunctivitis. However, China is currently lacking related guidelines. Allergic conjunctivitis has some of the same symptoms and signs as other infections/non-infectious conjunctival inflammation. When the symptoms and signs are atypical, it is prone to missed diagnosis and misdiagnosis, resulting in prolonged disease duration, drug abuse and waste of medical resources.

The current abuse of antibiotics is considered to be a huge problem in the treatment of ocular surface diseases. A study in our country believes that the rate of misdiagnosis of dry eye is as high as 66.2%, and most of them are misdiagnosed as chronic conjunctivitis, resulting in frequent using a variety of antibiotic eye drops. At present, the misdiagnosis of allergic conjunctivitis and the abuse of antibiotics caused by misdiagnosis in China are still unclear, therefore clinical research is urgently needed. We intend to use this study to understand the status of diagnosis and treatment of allergic conjunctivitis in China, and provide clinical evidence for the standard diagnosis and treatment of allergic eye diseases.

Eligibility criteria: Inclusion Criteria:

* Patients whose clinical diagnosis is allergic conjunctivitis.

Exclusion Criteria:

* The investigator believes that there are any unsuitable reasons for participating in the trial.

Primary outcomes:
measure: Specific diagnosis of the patients
timeFrame: Until the study completion, up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center of Sun yat-sen Universtiy
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Xiaofeng Lin
role: STUDY_CHAIR
References:
Clinical trial NCT04041752: Meal Texture and Satiety
Official title: Satietogenic Effect of Liquid Versus Solid Meals in Healthy Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Normal Weight
Keywords: Meal texture
Appetite
Energy compensation
Food reward
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Appetite Control and Energy Balance Research Group, UNiversity of Leeds, Leeds, UK
name: Université d'Auvergne
First posted: 2019-08-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants complete the same conditions
Primary purpose: PREVENTION

Brief summary: The aim of the present study is to compare the nutritional compensation between iso-caloric meals of various textures (liquid vs solid) in health young adults.

Detailed description: The present study will compare the potential energy intake compensations, appetite feelings response, food reward variations and satiating responses after the ingestion of three different lunch meals: i) one classical cooked meal; ii) one iso-energetic meal consumed using a pre-prepared liquid meal; iii) one iso-energetic meal consumed using a prepared liquid meal. This will be the first study to assess all these nutritional factors after such meals.

Eligibility criteria: Inclusion Criteria:

* being aged 18 to 25 years old
* Being normal weight with a BMI between 20 and 25 kg/m²
* Being registered with a social security number

Exclusion Criteria:

* Eating disorders
* Specific food allergies or habits
* being under diet

Primary outcomes:
measure: Change in Spontaneous Energy intake measured
timeFrame: day 1 , day 8, day 15
Secondary outcomes:
measure: Hunger feelings
timeFrame: day 1 , day 8, day 15
measure: Food reward
timeFrame: day 1 , day 8, day 15
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: yves Boirie
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04417452: Long-term Outcome After Gestational Diabetes and Diabetes in Pregnancy
Official title: Effects of Fetal Programming on the Metabolic, Cardiovascular, Neurocognitive and Reproductive Health of Offsprings and Their Mothers After Pregnancies With Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes, Gestational
Pregnancy Diabetic
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study collective is composed of mother-child pairs after gestational diabetes, which were supervised in the Competence Center for Diabetes and Pregnancy at the University Hospital of Jena. The patients can decide to fill in an online questionnaire. For all other parts of the study, only patients who have been informed independently or on behalf of their legal guardian about the nature of the study after a detailed and understandable explanatory discussion with an investigator and who have given written consent will be included in the study.

Brief summary: The primary objectives of the proposed project are to assess the long-term effects of prenatal exposure to gestational diabetes or diabetes on the maturation and health of the offspring. In addition, the long-term changes on the health of the affected mothers will be investigated, taking into account the metabolic adjustment during index pregnancy. The expected results will help to establish possible prevention strategies to fight the epidemic of non-communicable diseases for the offspring and the mothers.

Detailed description: Investigation of the long-term outcome of mother-child pairs after diabetic pregnancies and a comparison group regarding metabolic, cardiovascular, neurocognitive and reproductive long-term changes as a function of the course of pregnancy and metabolic control

Eligibility criteria: Inclusion Criteria:

* For the pilot project: Initial participation in the preliminary study
* Written Informed Consent
* Singleton pregnancies
* Delivery at the University Hospital Jena

Exclusion criteria:

* Severe physical and mental illness
* Patients who refuse to participate in the study or drop out
* Premature birth, i.e. birth of the child \<37/0 weeks of gestation
* Serious pregnancy complications
* Prenatally known serious malformations

Primary outcomes:
measure: Metabolic health
timeFrame: 1 day examination at the study centre
measure: Neurocognitive development
timeFrame: 1 day examination at the study centre
measure: Cardiovascular and vascular health
timeFrame: 1 day examination at the study centre
measure: Maturation of the gonadal regulation
timeFrame: 1 day examination at the study centre
Secondary outcomes:
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Universitätsklinikum Jena
state: Thüringen
Study officials:
affiliation: Klinik für Geburtsmedizin
name: Friederike Weschenfelder, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05733052: Pubourethral Ligament Plication for the Surgical Treatment of Stress Urinary Incontinence
Official title: Pubourethral Plication Procedure (PPP) Cures Stress Urinary Incontinence Without Tapes- First Report.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Pelvic Floor Disorders
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 36
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To test efficacy and safety at six months of the proposed Pubourethral Plication Procedure (PPP) for cure of stress urinary incontinence - reinforcing pubourethral ligaments (PUL) with large diameter polyester sutures.

Detailed description: Full thickness vaginal incisions will be made in the suburethral sulci extending from bladder neck to urethral meatus. The operation space is 2.5cm2 space. A No2 or 3 polyester suture will be inserted into PUL, immediately lateral to midurethra, into PUL origin, external urethral ligament, laterally into m.pubococcygeus, then will be tied, but not tightly. The vaginal incisions will be closed with vicryl sutures. All women will be discharged on day of surgery. During the regular follow ups the healing at stress urinary incontinence will be evaluated

Eligibility criteria: Inclusion Criteria:

* Urine loss on coughing controlled by hemostat behind symphysis

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Curing effect of the suturation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Muğla Training and Research Hospital
Study officials:
affiliation: Mugla SITKI KOÇMAN UNİVERSITY
name: AHMET AKIN SIVASLIOGLU, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01736852: Evaluation of CRB in PROM Patients
Official title: Randomized Study to Compare the Cook Cervical Ripening Balloon (CRB) Plus Pitocin to Pitocin Alone in Premature Rupture of Membranes (PROM) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Rupture of Fetal Membranes
Keywords: Premature Rupture of Membrane (Pregnancy)
PROM
Cervical Ripening
Induced Labor
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 129
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The CRB study is designed to study the safety and effectiveness of the Cook Cervical Ripening Balloon (CRB) for the induction of labor in term and near-term patients with premature rupture of membranes (PROM).


Eligibility criteria: Inclusion Criteria:

* PROM not in labor

Exclusion Criteria:

* Contraindication to vaginal delivery
* Contraindication to labor induction
* Abnormal fetal heart-rate patterns
* Maternal heart disease
* Severe maternal hypertension
* Pelvic structural abnormality

Primary outcomes:
measure: Time of Labor
timeFrame: Start of labor induction through delivery, an expected average of 6 hours
measure: Incidence of Infection
timeFrame: Through hospital discharge, an expected average of 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tucson Medical Center (TMC)
state: Arizona
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Louisville
country: United States
facility: Kosair Children's Hospital Maternal Fetal Medicine Specialists
state: Kentucky
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: Watching Over Mothers and Babies (WOMB)
name: Hugh Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04673552: Open Surgery for Necrotizing Pancreatitis
Official title: Open Surgery for Necrotizing Pancreatitis in the Era of Minimally Invasive Approach: 10-year Experience in a High-volume Centre
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatitis,Acute Necrotizing
Keywords: necrotizing pancreatitis
laparotomy
debridement
Lead sponsor: Northern State Medical University
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In-hospital patients of the First Emergency City Hospital named after E. E. Volosevich

Brief summary: Retrospective analysis of the cases of traditional open surgery for acute necrotizing pancreatitis, with evaluation of indications for surgery, intraoperative findings, mortality rate and risk factors of mortality.

Detailed description: All cases of laparotomy/lumbotomy will be retrospectively analysed, with evaluation of mortality, complications, in-hospital stay, indications for surgery, findings during operation, combination with minimally invasive procedures (radiological drainage, necrosectomy). Assessment of risk factors, like erosive bleeding, intraperitoneal perforation of collection, gut resection, splenectomy, relaparotomy will be done.

Eligibility criteria: Inclusion Criteria:

* laparotomy or lumbotomy performed for acute necrotizing pancreatitis from January, 2008 to December, 2017

Exclusion Criteria:

* N/A

Primary outcomes:
measure: survival
timeFrame: 01.001.2008 - 31.12.2017
measure: death
timeFrame: 01.001.2008 - 31.12.2017
Secondary outcomes:
Other outcomes:
Locations:
city: Arkhangel'sk
country: Russian Federation
facility: Northern State Medical University
state: Arkhangelsk Region
Study officials:
affiliation: Northern State Medical University
name: Denis Mizgirev, DoctMedSci
role: PRINCIPAL_INVESTIGATOR
References: