louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06364306: oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias
Official title: oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias - the PRIOR Multicentre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ventral Hernia
Incisional Hernia
Abdominal Wall Defect
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: St. Clara Hospital, Basel, Switzerland
name: Klinikum Kempten, Kempten, Germany
First posted: 2024-04-15
Enrollment: 140
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 study investigates on the effect of two different operative techniques to treat large abdominal wall defects.

The goal of this clinical trial is to learn if the minimally-invasive, robotically-assisted ventral hernia repair (RVHR) leads to a better outcome than the open ventral hernia repair (OVHR).

The main questions it aims to answer are:

length of stay after the operation rate of complications rate of recurrence and reoperations quality of life.

Participants will:

Either be operated using the RVHR or OVHR will be followed up either in person or via email / phone call at day 7, day 30, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes.


Eligibility criteria: Inclusion Criteria:

* Patient age \>18 years
* Informed consent obtained
* Transverse diameter of ventral hernia \>4cm - 15cm
* Eligible to open and minimally-invasive surgery according to preoperative anaesthetic assessment

Exclusion Criteria:

* precedent hernia treatment with mesh placement in the retromuscular space
* precedent anterior or posterior component separation or transversus abdominis release (TAR)
* active wound infection
* current cancer diagnosis
* presence of ileostomy, colostomy or ileal conduit
* liver disease defined by the presence of ascites
* end-stage renal disease requiring dialysis
* need of an emergency surgery
* pregnancy

Criteria for participating surgeons Each participating surgeon has performed 20 or more OVHR and RVHR.

Primary outcomes:
measure: Primary outcome: length of stay
timeFrame: 30 days
Secondary outcomes:
measure: Comprehensive complication index (CCI)
timeFrame: 30 days
measure: Adverse events
timeFrame: 30 days
measure: pain after surgery
timeFrame: 5 years
measure: Functional recovery
timeFrame: 5 years
measure: Quality of life using SF-12 form
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Clarunis - Universitäres Bauchzentrum Basel
name: Johannes Baur, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clarunis - Universitäres Bauchzentrum Basel
name: Julian Süsstrunk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04201899: HYPOPhosphatemia in the Intensive Care: A One-day Point Prevalence Survey
Official title: Hypophosphatemia in the ICU - A One-day Point Prevalence Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critically Ill
Keywords: Phosphate
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: European Society of Intensive Care Medicine
First posted: 2019-12-17
Enrollment: 890
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: Critically ill patients: adults and children

Brief summary: The point prevalence survey aims at defining the until now unknown real prevalence of hypophosphatemia (defined as blood phosphate value \< 0.8 mmol/l) in international critical care settings

Detailed description: The survey will be conducted on one single day in each centre (D-day), within a week defined by the project coordinator (International PI). On D-Day, the local investigators will be asked

1. to complete questions aiming at describing their ICU (number of beds, number of patients present on D-Day, type medical/surgical/other, local phosphate reference value, presence of an hypophosphatemia treatment protocol in the ICU and route of phosphate delivery in case of hypophosphatemia)
2. to indicate how many patients had a blood phosphate \<0.08 mmol/l, for each patient with hypophosphatemia, to record the exact lowest value on D-Day, and to record age, number of days in ICU on D-Day, presence (or not) of artificial nutrition and continuous renal replacement therapy, if any phosphate administration is ongoing Data will be recorded in and electronic Case Report Form (e-CRF) in REDCap, and analysed with descriptive statistics No outcome data will be recorded (pure point-prevalence) There is no intervention

Eligibility criteria: Inclusion Criteria: blood phosphate value \< 0.8 mmol -

Exclusion Criteria: Blood phosphate value \>0.8 mmol/l

-

Primary outcomes:
measure: Prevalence of hypophosphatemia
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Nice
country: France
facility: Hôpital Pasteur 2
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital
state: VD
city: Nyon
country: Switzerland
facility: Hôpital de Nyon
Study officials:
affiliation: Lausanne University Hospital, Lausanne, Switzerland
name: Mette M BERGER, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berger MM, Appelberg O, Reintam-Blaser A, Ichai C, Joannes-Boyau O, Casaer M, Schaller SJ, Gunst J, Starkopf J; ESICM-MEN section. Prevalence of hypophosphatemia in the ICU - Results of an international one-day point prevalence survey. Clin Nutr. 2021 May;40(5):3615-3621. doi: 10.1016/j.clnu.2020.12.017. Epub 2020 Dec 29.
Clinical trial NCT03810599: Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
Official title: Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Cardiac rehabilitation adherence
Patient-reported outcomes
Post-traumatic growth
Anxiety
Depression
Adherence
Lifestyle
Self-reported health
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 870
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-post comparison.
Primary purpose: PREVENTION

Brief summary: An intervention study with longitudinal follow-up of patients with coronary artery disease undergoing early cardiac rehabilitation is designed.

Detailed description: The main objective of the study is to investigate patient-reported outcomes, their relation to clinical characteristics of the patients and the potential to predict health outcomes and adverse events in coronary artery disease patients participating in an early cardiac rehabilitation programme.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of coronary artery disease
* \>=18 years of age
* Has performed a negative exercise test (bike or treadmill) and thereby able to participate in exercise training.

Exclusion Criteria:

* Cognitive impairment
* Unstable angina pectoris
* Aortic stenosis
* Left ventricular ejection fraction \<30%
* Heart failure NYHA class III-IV
* Serious arrhythmia in need of treatment
* Being on the waiting list for percutaneous coronary intervention or coronary artery bypass grafting.

Primary outcomes:
measure: Time to composite of total mortality, and hospitalization for heart failure and atherothrombotic disease (including non-fatal MI, unstable angina and stroke).
timeFrame: Up to 10 years
Secondary outcomes:
measure: Change in Self-reported health
timeFrame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
measure: Change in self-reported global health
timeFrame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
measure: Change in post traumatic growth
timeFrame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
measure: Nicotine dependence
timeFrame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
measure: Change in anxiety and depression
timeFrame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
measure: Change in physical and mental dimensions of health
timeFrame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
measure: Change in health status following myocardial infarction
timeFrame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Tone M Norekvål, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02462499: Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population
Official title: Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Central Serous Chorioretinopathy
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 28
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: The aim of the study is to determine the efficacy and safety of treatment with the drug eplerenone in patients with chronic central serous chorioretinopathy.


Eligibility criteria: Inclusion Criteria:

* Chronic central serous chorioretinopathy (CSCR) with persistent subretinal fluid on OCT for more than 3 months after initial presentation .
* Written informed consent

Exclusion Criteria:

* Persons with impaired decision-making ability.
* Pregnant women or who are actively trying to conceive.
* Additional eye disease affecting the macula or posterior retina.
* Creatinine clearance \< 50 ml/min
* Hyperkalemia \> 5 mmol/l
* Serum creatinine \> 2 mg/dl in men or \> 1.8 mg/dl in women
* Treatment with potassium sparing agents or potassium
* Treatment with any other drugs known to cause interaction with eplerenone
* Microalbuminuria in patients with type 2 diabetes

Primary outcomes:
measure: Resolution of sub-retinal fluid measured by optical coherence tomography (OCT).
timeFrame: 6 months
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
timeFrame: 3 months
Secondary outcomes:
measure: Changes in macular volume at baseline, during and after the treatment with eplerenone.
timeFrame: 6 months
measure: Changes in visual acuity at baseline measured on Early Treatment of Diabetic Retinopathy Study (ETDRS) chart, during and after the treatment with eplerenone.
timeFrame: 6 months
measure: Changes in choroideal thickness at baseline measured by OCT, during and after the treatment with eplerenone in both eyes.
timeFrame: 6 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University, Department of Ophthalmology
Study officials:
References:
Clinical trial NCT03815799: The Effect of Ultrasound-Guided Erector Spinae Block on Respiratory Function After Laparoscopic Cholecystectomy
Official title: The Effect of Ultrasound-Guided Erector Spinae Block on Respiratory Function After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Postoperative Pain
Respiratory Function
Keywords: Erector Spinae Block
Laparoscopy
Respiratory Function
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the effect of ultrasound guided erector spinae block in control of the postoperative pain and the respiratory functions after laparoscopic cholecystectomy.


Eligibility criteria: Inclusion Criteria:

• American Society of Anesthesiology (ASA) physical status I-II patients who were scheduled for elective laparoscopic cholecystectomy

Exclusion Criteria:

* Patients refusal
* Contraindications for regional anesthesia
* Alcohol or drug abuse
* Chronic opioid intake
* Patient with psychiatric disorders
* Use of pain killers within the 24 h before the operation
* Respiratory tract infection within the last 2 weeks
* Smoker or history of smoking
* Allergy to local anesthetics
* Respiratory and allergic diseases
* Cardiac disease associated with dyspnea

Primary outcomes:
measure: Scoring of postoperative pain
timeFrame: Postoperative 24 hour
Secondary outcomes:
measure: Analgesic consumption
timeFrame: Postoperative 24 hour
measure: Spirometric Parameters of Respiratory Functions
timeFrame: Preoperative (before the surgery) and at postoperative 24th hour
measure: Number of Adverse events
timeFrame: Postoperative 24 hour
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Education and Training Hospital
Study officials:
References:
citation: Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.
citation: Basaran B, Basaran A, Kozanhan B, Kasdogan E, Eryilmaz MA, Ozmen S. Analgesia and respiratory function after laparoscopic cholecystectomy in patients receiving ultrasound-guided bilateral oblique subcostal transversus abdominis plane block: a randomized double-blind study. Med Sci Monit. 2015 May 7;21:1304-12. doi: 10.12659/MSM.893593.
citation: Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
Clinical trial NCT04350099: Emotional Burden of Healthcare Professionals and Covid Infection 19
Official title: Emotional Burden of Healthcare Professionals and the Epidemic Related to Covid Infection 19 -
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Emotionnal Distress; COVID-19
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 200
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: Health professional working

Brief summary: COVID-19 ( known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)) has a highly polymorphic clinical presentation, ranging from pauci-symptomatic infection to severe, potentially complicated forms with acute respiratory distress syndrome or multisystemic organs failure. The picture may be initially severe, or it may progress in two stages, with worsening 7 to 10 days after the first symptoms with an overall case-fatality rate of 3 to 4%.

Its management is essentially symptomatic, as no antiviral treatment has so far demonstrated a clinical benefit in this condition.

In such a context, healthcare professionals assigned to COVID units will be faced with a heavy workload and emotional burden that could lead to psychological suffering or even burnout and its consequences.

We would therefore like to describe, using validated tools, the emotional evolution of the care workers at the Limoges University Hospital and the Esquirol University Hospital faced with this new pandemic infection. An initial and end-of-study evaluation of the caregivers will be carried out concerning their anxiety and depressive state, their personal capacity for resilience and their degree of empathy


Eligibility criteria: Inclusion Criteria:

* Health professional working in a COVID unit
* For the qualitative study: 24 participant selected at random to be interviewed

Exclusion Criteria:

* Refusal to participate

Primary outcomes:
measure: anxiety
timeFrame: 7 days,
measure: anxiety
timeFrame: 15 days,
measure: anxiety
timeFrame: 1 month
measure: anxiety
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: CH Esquirol
city: Limoges
country: France
facility: CHU de Limoges
city: Lyon
country: France
facility: HCL LYON
Study officials:
References:
Clinical trial NCT06713499: A Phase Ib/II Study to Investigate the Safety of SHR-1819 in Children and Adolescents With Moderate-to-severe Atopic Dermatitis
Official title: A Phase Ib/II Study to Investigate the Safety、PK and PD of SHR-1819 in Children and Adolescents With Moderate-to-severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Children and Adolescents With Moderate-to-severe Atopic Dermatitis
Lead sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-12-03
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial was designed to evaluate the safety of SHR-1819 in children and adolescents with moderate-to-severe atopic dermatitis.


Eligibility criteria: Inclusion Criteria:

1. Subjects and their parents or legal guardians have voluntarily signed the informed consent form prior to the start of any procedures related to the study, are able to communicate smoothly with the investigator, understand and are willing to strictly comply with the requirements of this clinical study protocol to complete the study;
2. At the time of signing the informed consent, the subjects were ≥ 6 years old and \< 18 years old, male or female;
3. Have atopic dermatitis at screening.

Exclusion Criteria:

1. Before enrollment, the subjects weighed \< 15kg;
2. Females who are pregnant or lactating and have a positive pregnancy test result;
3. Have other active skin disease or skin complications due to other conditions that may affect the evaluation of AD;
4. Have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial;
5. Treated with biologics targeting IL-4Rα , or participated in previous clinical studies of biologics targeting IL-4Rα, including SHR-1819 injection;
6. Has malignancy or has a history of malignancy;
7. Hypersensitivity to the study drug or any ingredient in the study drug.

Primary outcomes:
measure: Adverse events
timeFrame: Up to 14 weeks.
measure: Heart rate
timeFrame: Up to 14 weeks.
measure: PR interval
timeFrame: Up to 14 weeks.
measure: QT interval
timeFrame: Up to 14 weeks.
measure: QRS duration
timeFrame: Up to 14 weeks.
Secondary outcomes:
measure: The concentration of SHR-1819 in serum
timeFrame: From the beginning of administration to the 14th week.
measure: Changes in the level of TARC/CCL17 in the serum
timeFrame: From the beginning of administration to the 14th week.
measure: Evaluate the incidence and timing of ADA positivity for SHR-1819
timeFrame: From the beginning of administration to the 14th week.
Other outcomes:
Locations:
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
Study officials:
References:
Clinical trial NCT05887999: A Study of LY3532226 in Participants With Type 1 Diabetes Mellitus
Official title: A Phase 1, Randomized, Placebo-Controlled, 2-Period, Cross-over, Double- Blind, Single-Dose Study to Evaluate the Effects of LY3532226 on Insulin- Induced Hypoglycemia in Participants With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-06-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the response of glucagon to insulin-induced low blood sugar after administration of the study drug LY3532226 in participants with type 1 diabetes mellitus (T1DM). The study will also evaluate if LY3532226 helped participants to recover from insulin-induced low blood sugar condition compared to placebo. The study will last approximately 16 weeks excluding screening period.


Eligibility criteria: Inclusion Criteria:

* Participants with type 1 diabetes mellitus (T1DM) for at least 2 years treated with insulin
* Body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m²)
* Are males or females not of childbearing potential

Exclusion Criteria:

* Have acute proliferative retinopathy requiring active treatment within 3 months of screening
* Have been treated with dipeptidyl peptidase-Ni, GLP-1 receptor agonists, GIP agonists, metformin or sodium-glucose cotransporter 2 inhibitors within the previous 3 months
* Have received systemic or inhaled glucocorticoid therapy
* Women of childbearing potential
* Are currently taking part in another clinical study trial involving medical research, or have participated within the last 30 days of screening in a clinical study involving a study intervention

Primary outcomes:
measure: Pharmacodynamics (PD): Area under the concentration versus time curve from time 60 to 120 minutes (AUC60-120min) of plasma glucagon during the insulin-induced hypoglycemia
timeFrame: Predose up to 120 mins postdose
Secondary outcomes:
measure: The amount of exogenous glucose infused to maintain a plasma glucose level of >2.5 millimole per liter (mmol/L), after the insulin infusion is terminated.
timeFrame: Predose up to 120 mins postdose
measure: Change from Baseline in Fasting and Post meal Glucose during Standardized Mixed-meal Tolerance Test (sMMTT)
timeFrame: Predose up to 120 mins postdose
measure: Change from Baseline in Glucagon Concentration at Fasting and Post meal during sMMTT
timeFrame: Predose up to 120 mins postdose
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: ProSciento, Inc
state: California
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: