louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02384148: Study of Circadian Clock Properties in Healthy Subjects, Obese and Type 2 Diabetic Patients.
Official title: Measure and Comparison of Molecular Circadian Clock Properties in Healthy Subjects, Obese and Type 2 Diabetic Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Circadian Rhythm
Diabetes
Obesity
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2015-03-10
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One hundred normolipidemic healthy individuals, one hundred T2D subjects divided into two sub-groups (T2D non-obese and T2D obese) and one hundred obese non diabetic patients will be included.

Brief summary: The investigators aimed to characterize human circadian clockwork in healthy individuals in comparison to obese and type 2 diabetic subjects, employing the noninvasive experimental approach allowing the study of circadian profile in human individuals.

Detailed description: The investigators specifically aim to obtain and analyze the circadian profile of skin fibroblasts from healthy, obese and T2D subjects. Does circadian oscillator profile and its parameters (phase, period and amplitude) will differ between healthy individuals and obese/ T2D patients? Skin biopsy will be performed in order to collect and culture skin fibroblast cells.

In vivo bioluminescence recording will be performed in primary human skin fibroblast cells. The profiles obtained from 10 subjects in each group will be compared to their healthy counterparts.

Bmal1and Per2 are clock genes. Lentiviral transduction of Bmal1-luciferase or Per2-luciferase in fibroblasts allow observation of circadian oscillations using bioluminescence assay. Phase, period length and amplitude are used to characterize the circadian rhythm.

Eligibility criteria: Inclusion Criteria:

* age 20-80
* consent obtained

Exclusion Criteria:

* neoplasia
* inflammatory disease
* allergy to lidocaine

Primary outcomes:
measure: Difference of period length
timeFrame: 5 days
Secondary outcomes:
measure: Difference of amplitude
timeFrame: 5 days
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospital
Study officials:
References:
citation: Pagani L, Schmitt K, Meier F, Izakovic J, Roemer K, Viola A, Cajochen C, Wirz-Justice A, Brown SA, Eckert A. Serum factors in older individuals change cellular clock properties. Proc Natl Acad Sci U S A. 2011 Apr 26;108(17):7218-23. doi: 10.1073/pnas.1008882108. Epub 2011 Apr 11.
citation: Brown SA, Fleury-Olela F, Nagoshi E, Hauser C, Juge C, Meier CA, Chicheportiche R, Dayer JM, Albrecht U, Schibler U. The period length of fibroblast circadian gene expression varies widely among human individuals. PLoS Biol. 2005 Oct;3(10):e338. doi: 10.1371/journal.pbio.0030338. Epub 2005 Sep 27.
Clinical trial NCT05016648: Cerebral Hemodynamics During Sustained Intra-operative Hypotension
Official title: Cerebral Hemodynamics During Sustained Intra-operative Hypotension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Autoregulation
Keywords: cerebral autoregulation
PEARS
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients planned for the PEARS procedure at the AMC.

Brief summary: Objective:

The objective of this study is to describe the physiology of the cerebral autoregulation over time during extreme low blood pressures (BP).

Study design:

This is a retrospective data collection study. During the Personalized External Aortic Root Support (PEARS) procedure extreme low blood pressures \< 65 mmHg are medically induced. Hemodynamic and neurophysiologic data is for clinic purposes stored.

Study population:

All patients requiring a PEARS study at the Amsterdam University Medical Centers, location Amsterdam Medical Center (AMC).

Investigation:

Cerebral parameters during sustained low blood pressures are monitored with the transcranial doppler (TCD) for cerebral blood flow velocity (CBFV), near infrared spectroscopy (NIRS) for cerebral tissue oxygenation (rS02) and the electroencephalography (EEG) for the cerebral activity. Blood pressure waveforms are retrieved from an invasive arterial catheter. Besides, blood gasses during the low blood pressures and cardiac output, measured with a Schwan Ganz catheter are collected as well as electronic health records (EHR) (like age, gender and weight). All these devices are implemented as stated in the clinic protocol.

Main study parameters/endpoints:

The investigators will describe the cerebral autoregulation (CA) in several ways to retrieve a cut-off or lower limit of the CA where the regulation is either intact or impaired. First the static CA will be created with the mean arterial pressure (MAP) and mean cerebral blood flow (CBFm), second, the CA will be described with the mean flow velocity index (Mx, a method which calculates the correlation between the MAP and CBFm), COX (correlation between MAP and rS02) and with data of the EEG.

After retrieval of the cut off or lower limit, the CA below this point will be described over time to check for differences.


Eligibility criteria: Inclusion Criteria:

* Planned for a PEARS procedure
* Informed consent should be given

Exclusion Criteria:

* No informed consent

Primary outcomes:
measure: Cerebral autoregulation
timeFrame: During the entire operation, about 4 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: AUMC
state: Noord-holland
Study officials:
References:
Clinical trial NCT05422248: Oxygen Wound Therapy Feasibility Study
Official title: Oxygen Wound Therapy Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Leg Ulcer
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2022-06-16
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Determine the feasibility of using a new topical oxygen therapy device to treat hard to heal lower leg wounds.


Eligibility criteria: Inclusion Criteria:

* Patients with hard to heal lower leg wounds as determined by the treating clinician.
* Patient has a wound area greater than the area of the interface
* Aged 16 years and over
* Able to provide informed consent

Exclusion Criteria:

* Lower limb wounds with bone or tendon exposed
* Infected wounds which require treatment with antibiotics
* Wounds with critical bioburden requiring a medicated dressing
* Wounds that require dressing changes more than every second day, for example high exudating wounds
* Wounds with slough covering more than 30% of the wound surface

Primary outcomes:
measure: Change in wound area
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dunedin
country: New Zealand
facility: Otago Vascular Diagnostics
state: Otago
Study officials:
affiliation: Southern DHB Vascular Surgery
name: Jolanta Krysa
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06393348: Efficacy and Safety of HRS-7535 Tablets in T2DM Subjects Poorly Controlled With Metformin and SGLT2i.
Official title: A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Phase ⅡStudy to Evaluate the Efficacy and Safety of HRS-7535 in T2DM Subjects Poorly Controlled With Metformin and SGLT2i.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 2 weeks screening period, 3 weeks run-in period, 16 weeks double-blind treatment period, to evaluate the Safety and Efficacy of HRS-7535 in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin and SGLT2i.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects, 18-75 years of age at the time of signing informed consent;
2. Have T2DM (based on the 2020 Chinese Diabetes Society \[CDS\] diagnostic criteria)
3. HbA1c为7.5%≤HbA1c≤11.0% at the screening visit；
4. FPG≤15 mmol/L at the screening visit;
5. Have been treated with an SGLT2i with metformin, for at least 8 weeks;
6. At screening and random visit, 20.0 ≤BMI≤ 35.0 kg/m2;
7. Able and willing to provide a written informed consent

Exclusion Criteria:

1. Have type 1 diabetesmellitus;
2. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
3. Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix;
4. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
5. Surgery is planned during the trial;
6. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;

Primary outcomes:
measure: Change in HbA1c from baseline at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Proportion of subjects achieving HbA1c target of <7.0% at 16 weeks
timeFrame: 16 weeks
measure: Proportion of subjects achieving HbA1c target of ≤6.5% at 16 weeks
timeFrame: 16 weeks
measure: The change in fasting blood glucose from baseline to 16 weeks
timeFrame: 16 weeks
measure: The change in in body weight from baseline to 16 weeks
timeFrame: 16 weeks
measure: The change in 7-point SMBG profile from baseline to 16 weeks
timeFrame: 16 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00560248: The BEACON Registry: Best Expert Agreement for Care of Occult Myocardial Infarction (MI) Nationally
Official title: The BEACON Registry: Best Expert Agreement for Care of Occult MI Nationally
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chest Pain
Keywords: Chest Pain
STEMI
UA/NSTEMI
ACS
Emergency Department
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Heartscape Technologies, Inc.
name: Novella Clinical
name: PharmaVigilant
First posted: 2007-11-19
Enrollment: 1897
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the Emergency Department with chest pain.

Brief summary: The purpose of this registry is to assess and improve the process of care and health outcomes of patients presenting to the Emergency Department with chest pain suspected to be of cardiac origin. The study will identify which methods facilitate the diagnosis and risk stratification of ST elevation myocardial infarction (STEMI) or non STEMI, including patients with occult myocardial infarction (MI), and result in a shorter time to definitive diagnosis and treatment.

Detailed description: The BEACON Registry is a multi-center data collection and follow-up registry. Participating Sites will collect information on patients presenting to the Emergency Department (ED) with chest pain. The purpose of the BEACON Registry is to evaluate the impact of new technologies, practice patterns and initiatives on patient time to diagnosis, patient time to treatment, patient survival and overall economics.

Eligibility criteria: Inclusion Criteria:

* Patients presenting with chest pain suspected to be of cardiac origin.

Exclusion Criteria:

* None

Primary outcomes:
measure: Time to definitive diagnosis of STEMI, UA/NSTEMI and non-cardiac chest pain; time to disposition decision will be used as an objective measure of time to definitive diagnosis
timeFrame: Index hospitalization
Secondary outcomes:
measure: Time to treatment, economic outcomes and survival outcomes
timeFrame: 1 year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: William F. Peacock, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Boston Healthcare System
name: Deepak L. Bhatt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Venugopal Menon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01476748: Intraoperative Trocar Slippage Study
Official title: A Pilot Study to Determine the Extent of Intraoperative Laparoscopic Trocar Slippage.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Trocar Slippage
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2011-11-22
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out how much a trocar might slide during a typical laparoscopic hysterectomy. We also want to find out if there is a difference between how much three commonly used trocars slide and if a device called LaproStop has an effect on the slippage.

Patients will be randomly assigned into the different trocar groups. After this assignment has been made, we will then assign the Laprostop to one of the two trocars by chance.


Eligibility criteria: Inclusion Criteria:

* Women undergoing a hysterectomy at Brigham and Women's Hospital and Faulkner Hospital.

Exclusion Criteria:

Primary outcomes:
measure: Trocar Slippages With LaproStop
timeFrame: During the hysterectomy procedure, up to 2 hours and 32 minutes
Secondary outcomes:
measure: Trocar Slippages Without LaproStop
timeFrame: During the hysterectomy procedure, up to 2 hours and 32 minutes
Other outcomes:
Locations:
city: Boston
country: United States
facility: Minimal Invasieve Gynaecology Surgery, Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jon I Einarsson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02523248: Comparison Between UPPP and Tonsillectomy in Adult OSA
Official title: Randomized Control Study Between Uvulopalatopharyngoplasty and Tonsillectomy in Adult Sleep Apnea Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized control study is to evaluate the effect of tonsillectomy with or without uvulopalatoplasty in treating adults with moderate to severe sleep apnea.

Detailed description: Patients are after baseline PSG 1 included and randomized to either UPPP or TE. They are stratified according to tonsil size, those with size 2 in one group and those with 3-4 in another. They all undergo surgery within two months and thereafter PSG 2 after 6 months and PSG after 4 years. At PSG they fill in questionnaires and measurements of blood pressure.

Eligibility criteria: Inclusion Criteria:

* AHI more than 15
* Friedmans stage I and II
* Tonsil size 2, 3 and 4
* BMI below 34
* Failed use of CPAP and dental device

Exclusion Criteria:

* Severe cardiovascular or neurological disease
* Prefers strongly one surgical method
* ASA IV

Primary outcomes:
measure: Polysomnography: group differences of changes in apnea-hypopnea index (AHI)
timeFrame: 6 months
Secondary outcomes:
measure: Questionnaire: group differences of changes in daytime sleepiness
timeFrame: 6 months
measure: Questionnaire: group differences in changes of general health
timeFrame: 6 months
measure: Group differences in changes of blood pressure
timeFrame: 6 months
Other outcomes:
measure: Polysomnography: group differences of changes in apnea-hypopnea index (AHI)
timeFrame: 4 years
measure: Questionnaire: group differences of changes in daytime sleepiness
timeFrame: 4 years
measure: Questionnaire: group differences in changes of general health
timeFrame: 4 years
measure: Questionnaire of pharyngeal side-effects pre-and postoperatively
timeFrame: 6 months
measure: Postoperative bleeding complications
timeFrame: 6 months
Locations:
city: Stockholm
country: Sweden
facility: Orl dep, Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital, ORL dep
name: Bo Tideholm, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Sundman J, Nerfeldt P, Fehrm J, Bring J, Browaldh N, Friberg D. Effectiveness of Tonsillectomy vs Modified Uvulopalatopharyngoplasty in Patients With Tonsillar Hypertrophy and Obstructive Sleep Apnea: The TEAMUP Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Dec 1;148(12):1173-1181. doi: 10.1001/jamaoto.2022.3432.
Clinical trial NCT03346148: Staff Management About Food Allergy Into ResTaurants
Official title: Staff Management About Food Allergy Into ResTaurants in Metz and Strasbourg
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food Allergy
Keywords: Food Allergy, Restaurant staff
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Restaurant staff member

Brief summary: Assessment of the knowledge levels of restaurant personnel about food allergies. A structured questionnaire was given through a telephonic interview to evaluate the responses of the respondents.

Detailed description: Food allergy is a common disease affecting children and adults in Europe. It's a burden for patients, with an important impact on quality of life. Dining in restaurants may be dangerous for allergic consumers. Currently in France, little training on food allergies is included in the generic food hygiene training that is compulsory for only a minimum of one member of the staff of a restaurant.

Eligibility criteria: Inclusion Criteria:

* Etablished in Metz or Strasbourg
* Restaurant staff member

Exclusion Criteria:

-

Primary outcomes:
measure: knowledge about food allergy
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01306448: Safety Evaluation of the Vibrating Capsule
Official title: Safety Evaluation of the Vibrating Capsule in Aiding Reliving Constipated Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Keywords: constipation
gastro
vibrating capsule
safety
Lead sponsor: Vibrant Ltd.
Sponsor class: INDUSTRY
First posted: 2011-03-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will assess the safety of the vibrating capsule in healthy volunteers first and than for constipation relief constipated individuals.

Detailed description: Healthy volunteers will be followed for safety for 7 days after taking the capsule.

Constipated individuals will be first followed for 2 weeks and than they will use the capsule for 7.5 weeks period. Safety and efficacy will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Patients age 18-60 years
* Ability of subject to understand character and individual consequences of clinical trial
* Written informed consent must be available before enrollment in the trial
* For women with childbearing potential, adequate contraception

Exclusion Criteria:

* Patient with Diverticulosis
* Patient must not use protocol-defined prohibited medicine
* History of or current diagnosis of cardiovascular ischemic disease (e.g., angina pectoris, myocardial infarction, transient ischemic attack or stroke and including findings suggestive of ischemia on an ECG such as changes in ST segment and T waves, and / or Q wave)
* Clinical evidence of significant (as judged by the Investigator) respiratory, cardiovascular, renal, hepatic-biliary, endocrine, psychiatric or neurologic diseases or presence of abdominal adhesions
* Presents of pacemakers
* History of or current eating disorder such as anorexia or bulimia or compulsory overeating.
* Diagnosis of mega-rectum or colon, a history of intestinal obstruction, congenital anorectal malformation, clinically significant rectocele, or any evidence of intestinal structural abnormality including gastrointestinal resection that affected bowel transit or any evidence of intestinal carcinoma, of inflammatory bowel disease or of alarm symptoms such as weight loss, rectal bleeding, or anemia.
* Actively participating in another clinical trial

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: 7.5 weeks of treatment period
Secondary outcomes:
measure: Change in spontaneous bowel movement per week compared to baseline
timeFrame: 9.5 weeks
measure: Patient assessment of capsule tolerability
timeFrame: 7.5 weeks of treatment period
Other outcomes:
Locations:
city: AShkelon
country: Israel
facility: Barzilai MC
city: Nazeret
country: Israel
facility: Italian Hospital
city: Tel Aviv
country: Israel
facility: Tel Aviv Souraski medical Center
Study officials:
References: