louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05125887: Remote Assessment of Outpatient With Severe Acute Respiratory Syndrome (SARS-CoV-2)
Official title: Remote Assessment of Outpatient With SARS-CoV-2
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV2 Infection
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who had a positive PCR (polymerase chain reaction assay ) meeting the eligibility criteria could be included

Brief summary: Outpatient management of patients with a milder form of COVID may be associated to an unfavorable initial or deferred course in relation to the pathology.. Outpatients represent the bulk of patients with COVID-19. To know their evolution, their secondary complications and identifying a profile of "at risk" patients is essential for the prevention and care of future non-hospitalized patients, in an epidemic context still active.

This study could make it possible to redefine the follow-up of outpatients. The study consists of a simple questionnaire and possibly a teleconsultation.


Eligibility criteria: Inclusion Criteria:

* Patients with a PCR (polymerase chain reaction assay ) positive for Sars-COV-2 between the start of the pandemic and May 11, 2020
* Outpatient care
* Inclusion 24 months from the date of diagnosis of Sars-COV-2 (± 6 months)

Exclusion Criteria:

* Patients in EHPAD (accommodation facilities for dependent elderly people), home, retirement home, center for disabled people
* Patients under protective measure, curators or guardianship
* Patients with a pathology or condition that does not allow them to express their wishes
* Patients hospitalized when performing PCR or within 10 days with Sars-COV-2

Primary outcomes:
measure: Medical procedures
timeFrame: At month 24
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: Médecine Interne A
Study officials:
References:
Clinical trial NCT00772187: Intraoperative and Postoperative Analgesia for Laparoscopic Surgery.
Official title: Intraoperative and Postoperative Analgesia for Laparoscopic Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Analgesia
Keywords: Laparoscopic surgery (general surgery).
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2008-10-15
Enrollment: 40
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: Main Hypothesis: laparoscopic surgery is very painful to patient during and after surgery. We would like to compare different analgesic methods.


Eligibility criteria: Inclusion Criteria:

* Laparoscopic (general) Surgery
* Age\>18
* ASA\<4
* Morning surgery

Exclusion Criteria:

* Patient refusal
* contra-indication for treatment

Primary outcomes:
measure: Good analgesic method with minimal side effect.
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
References:
Clinical trial NCT05548387: A Study to Evaluate the Pharmacokinetics and Safety Between HCP2202 and Co-administration of Each Component in Healthy Volunteers
Official title: A Randomized, Open Label, Single Dose, 4-period Replicate Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety After Administration of a Fixed-dose Combination Drug of HCP2202 or Co-administration of RLD2202 and RLD2203 in Healthy Volunteers Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2022-09-21
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2202 and co-administration of each component in fasting condition in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Age 19\~54 years in healthy volunteers 18.5 kg/m\^2 ≤ BMI \< 30 kg/m\^2, weight(men) ≥55kg / weight(women) ≥45kg
* 90 mmHg ≤ SBP \<140 mmHg, 50 mmHg ≤ DBP \<90 mmHg
* agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug.
* Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Subjects who judged ineligible by the investigator

Primary outcomes:
measure: AUCt
timeFrame: 0~24 hours
measure: Cmax
timeFrame: 0~24 hours
Secondary outcomes:
measure: AUCinf
timeFrame: 0~24 hours
measure: Tmax
timeFrame: 0~24 hours
measure: t1/2
timeFrame: 0~24 hours
measure: CL/F
timeFrame: 0~24 hours
measure: Vd/F
timeFrame: 0~24 hours
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Jeonbuk National University Hospital
name: Mingul Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00868387: Macronutrient Relations and Weight Loss in Obese Subjects
Official title: Effects of Macronutrient Relations on Body Weight, Body Composition, and Cardiovascular Risk Markers in Overweight Patients Attending a Telemedically Guided Weight Loss Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: weight reduction
low-carbohydrate
body fat
telemedicine
cardiovascular risk markers
Lead sponsor: Heart and Diabetes Center North-Rhine Westfalia
Sponsor class: OTHER
First posted: 2009-03-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The burden of overweight and obesity has dramatically increased during the last decades. High carbohydrate intake, particularly refined carbohydrates, probably increase the risk of obesity, type 2 diabetes, and metabolic syndrome. There is evidence that energy-restricted low-carbohydrate diets show greater weight loss and better improvement of cardiovascular risk markers compared to energy-restricted low-fat diets. Beside macronutrient relations, efficacy of weight loss programs depends on care and control. The investigators aim to investigate whether or not a carbohydrate-restricted telemedically guided weight loss program results in a more pronounced weight loss and influences metabolic risk markers more beneficial than a fat-restricted diet.

Detailed description: see brief summary.

Eligibility criteria: Inclusion Criteria:

* age 18-70 years
* body mass index \> 27 kg/m2

Exclusion Criteria:

* history of cardiovascular symptomatology
* cholelithiasis
* urolithiasis
* insulin dependent diabetes
* pacemaker implantation
* pregnancy
* lactation
* vegetarianism

Primary outcomes:
measure: body weight
timeFrame: 12 months
Secondary outcomes:
measure: waist circumference
timeFrame: 12 months
measure: blood pressure
timeFrame: 12 months
measure: blood lipids
timeFrame: 12 months
measure: parameters of glucose metabolism
timeFrame: 12 months
measure: fat mass
timeFrame: baseline, 12 months
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Heart Center North Rhine-Westfalia
state: North Rhine-Westfalia
Study officials:
affiliation: Heart Center NRW
name: Heinrich Koertke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frisch S, Zittermann A, Berthold HK, Gotting C, Kuhn J, Kleesiek K, Stehle P, Kortke H. A randomized controlled trial on the efficacy of carbohydrate-reduced or fat-reduced diets in patients attending a telemedically guided weight loss program. Cardiovasc Diabetol. 2009 Jul 18;8:36. doi: 10.1186/1475-2840-8-36.
Clinical trial NCT01805687: Single Dose Bronchodilatory Study in Asthma
Official title: A Single-Center, Open-Label, Single-Dose Evaluation of the Duration and Extent of Bronchodilation Following Administration of Zileuton CR 1200 mg in Subjects With Stable, Chronic Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Cornerstone Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to evaluate the bronchodilator effects of Zyflo CR in patients with chronic stable asthma.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of asthma for at least 5 years
* FEV1 of 50-85% predicted
* Reversible airway obstruction

Exclusion Criteria:

* Pregnant/nursing females
* Liver function tests greater than upper limit of normal

Primary outcomes:
measure: Change From Baseline in FEV1
timeFrame: 12 Hours
Secondary outcomes:
measure: Area Under the Curve (AUC)
timeFrame: 72 Hours
measure: Number of Subjects With Adverse Events
timeFrame: 72 Hours
Other outcomes:
Locations:
city: North Dartmouth
country: United States
facility: Northeast Medical Research Associates
state: Massachusetts
Study officials:
References:
Clinical trial NCT00241787: Progression of Sub-Clinical Atherosclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Cardiovascular Diseases
Heart Diseases
Carotid Artery Diseases
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-10-19
Enrollment: 2900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community based in Framingham MA

Brief summary: To determine the rate of progression of sub-clinical cardiovascular disease as measured in carotid intimal medial thickness over a period of 8 to 10 years.

Detailed description: BACKGROUND:

Strong associations exist between cardiovascular events and increased carotid artery wall intima-media thickness (IMT) as measured non-invasively by carotid ultrasound. Carotid IMT is accepted as a surrogate marker of sub-clinical cardiovascular disease.The study will determine the rate of progression of sub-clinical cardiovascular disease (change in IMT) over a period of 8 to 10 years.

DESIGN NARRATIVE:

The study will determine the rate of progression of sub-clinical cardiovascular disease (change in intimal medial thickness {IMT}) over a period of 8 to 10 years. Imaging and IMT measurements of approximately 2800 to 3000 members of the Framingham Offspring cohort having had baseline IMT measurements at their 1995-98 clinic visit will be repeated in 2005-2007. The principal aims of the project are to study the primary hypotheses that: 1. Interim exposure to traditional cardiovascular risk factors measured over 50 years is positively associated with the progression rate of carotid IMT. 2. Baseline carotid IMT and cumulative exposure to cardiovascular risk factors 20 years before the baseline visit are a better predictor of progression of sub-clinical disease after 8 to 10 years than the interim exposure to risk factors. 3. Novel risk factors such as C-reactive protein and homocysteine affect progression of carotid atherosclerosis more than traditional risk factors. This study will add a phenotypic marker of site-specific change in sub-clinical cardiovascular disease to the Framingham Study database. This complements ongoing research on the progression of sub-clinical cardiovascular disease and its associations with family history of premature cardiovascular events and genomic markers

Eligibility criteria: No eligibility criteria

Primary outcomes:
measure: Cardiovascular Morbidity
timeFrame: Longitudinal follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tufts Medical Center
name: Joseph F Polak, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03741387: The Effect of Message Framing on Blood Donation-Study 2
Official title: Saving a Life or Preventing a Death: the Effect of Message Framing on Blood Donation Among Rh Negative Donors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rh Negative Blood Donor
Lead sponsor: Guangzhou Blood Center
Sponsor class: OTHER_GOV
First posted: 2018-11-14
Enrollment: 795
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Rh negative blood group is a rare blood group in China, as it only accounts for 0.3-0.4 percent of the Han population. Therefore, low inventory is often found in blood collection and supply agencies in many regions in China. In order to assess the effects of the gain-versus-loss framing message on blood donation among Rh negative donors, we designed two kinds of self-administered, standardized and structured questionnaires. In addition of the basic socio-demographic characteristics, one questionnaire includes the questions which survey the attitude of saving patients lives, and the other was to survey the attitude of preventing patients from death. The questionnaires were randomly sent to Rh negative blood donors.


Eligibility criteria: Inclusion Criteria:

* Rh negative blood donors who have donated blood between 2016 and 2018.

Exclusion Criteria:

* People who are Rh negative blood type but never have donated blood.

Primary outcomes:
measure: The differences of attitude towards different massage framing
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Blood Center
state: Guangdong
Study officials:
References:
Clinical trial NCT03388333: Biomarkers in Patients Undergoing Atrial Fibrillation Ablation
Official title: A Single-center Observational Study to Find Biomarkers for the Outcome of Catheter Ablation in Patients With Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2018-01-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with atrial fibrillation schedulded for pulmonary vein isolation

Brief summary: The investigators aim to find biomarkers to determine the success of pulmonary vein isolation for the treatment of atrial fibrillation.

Detailed description: The investigators perform an observational study in patients undergoing pulmonary vein ablation to treat atrial fibrillation. Additionally, electrophysiological procedures not related to pulmonary vein isolation are also followed. The aim of the study is finding biomarkers that are able to predict short-term outcome of the procedure.The primary endpoint is defined as reoccurrences of atrial fibrillation within the first three months after pulmonary vein isolation.

Eligibility criteria: Inclusion Criteria:

* patients with atrial fibrillation scheduled for pulmonary vein isolation with either radiofrequency of cryoballoon
* patients scheduled for an electrophysiological study without ablation
* patients with a catheter ablation at the cavotricuspid isthmus for the treatment of right atrial flutter

Exclusion Criteria:

* patients with concurrent pulmonary vein isolation and ablation of the cavotricuspid isthmus
* Acute myocardial infarction, coronary artery bypass graft surgery or open heart surgery within less than 3 months prior to inclusion

Primary outcomes:
measure: Number of patients with short term reoccurrences of atrial fibrillation after ablation.
timeFrame: 3 months
Secondary outcomes:
measure: Change in heart rate after pulmonary vein isolation
timeFrame: 3 days.
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Department of Cardiology - Electrophysiology, University Heart Centre, University Hospital Hamburg-Eppendorf
Study officials:
affiliation: Germany Department of Cardiology - Electrophysiology, University Heart Centre
name: Christian Meyer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05741333: In-Office Clinical Study of the Solo+ TTD
Official title: Pivotal In-Office Clinical Study of the Solo+ Tympanostomy Tube Device
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ear Infection
Otitis Media
Lead sponsor: AventaMed DAC
Sponsor class: INDUSTRY
First posted: 2023-02-23
Enrollment: 66
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and effectiveness of the Solo+ Tympanostomy Tube Device (Solo+ TTD) for the placement of tympanostomy tubes in paediatric patients undergoing a tympanostomy procedure.

Detailed description: The study will be a multi-site, prospective, treatment-only study to gather safety and effectiveness data on the use of the Solo+ TTD in-office with topical anesthesia in children aged ≥6 months to \<13 years.

Eligibility criteria: Inclusion Criteria:

* Patients aged ≥6 months to \<13 years
* Planned tympanostomy tube insertion
* Patient is able to commit to the follow-up visits and assessments

Exclusion Criteria:

* Anatomy that precludes sufficient visualization of the tympanic membrane
* Anatomy that precludes safe access to the tympanic membrane and safe use of the Solo+ TTD
* Narrow ear canals
* Congenital or craniofacial abnormalities affecting the ear
* No baseline audiometry or tympanometry
* Familial history of insensitivity to anesthetic components
* Patient unable to remain still or is unsuitable for protective stabilization to undergo an in-office procedure

Primary outcomes:
measure: Procedure Success
timeFrame: Intra-operative
measure: Rate of Adverse Events
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexander City
country: United States
facility: Southern Head & Neck Surgery
state: Alabama
city: Huntsville
country: United States
facility: North Alabama ENT
state: Alabama
city: Opelika
country: United States
facility: East Alabama ENT
state: Alabama
city: Sacramento
country: United States
facility: Sacramento ENT
state: California
city: Louisville
country: United States
facility: Advanced ENT & Allergy
state: Kentucky
city: Bethlehem
country: United States
facility: Specialty Physician Associates
state: Pennsylvania
city: Columbia
country: United States
facility: South Carolina ENT
state: South Carolina
Study officials:
affiliation: Queen's Medical Center
name: Matija Daniel
role: STUDY_CHAIR
References:
Clinical trial NCT03680833: Sentinel Node Detection in Cervical Cancer
Official title: Sentinel Node Detection in Cervical Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sentinel Lymph Node Biopsy
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 226
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective cohort study
Primary purpose: DIAGNOSTIC

Brief summary: Evaluation of sensitivity of Sentinel lymph nodes for detecting nodal metastases in cervical cancer

Detailed description: Consecutive women with stage 1a2-2a1 cervical cancer scheduled for surgery will be approached for eligibility by defined criteria.

Sentinel nodes will be detected by a combined use of Indocyanine green and Tc99 radiocolloid ( first 75 patients) and for the continuation with either the combined use or the best performing of those tracers.

Technical success rates, adverse events (related study intervention and overall) sensitivity and negative predictive values will be estimated.

An interim analyse will be performed after 34 node positive patients based on the Fleming two stage analyse. The null hypothesis of sensitivity of 85% will be tested against an estimated sensitivity of 95%. At this stage the study may be closed for futility, closed as hull hypothesis is rejected or continued to reach another 28 node positive patients.

As a full pelvic lymphadenectomy will be performed after detection of sentinel nodes patient will act ast their own controls.

Eligibility criteria: Inclusion Criteria:

* Women of age 18 years and older at the time of informed consent.
* Women with a pathologically proven cervical carcinoma of any histologic subtype, clinically stage 1a2- 2a1 planned for primary surgery
* Absence of any exclusion criteria

Exclusion Criteria:

* Non consenting patients
* Ongoing pregnancy
* Inability to understand written and/or oral study information
* Who performance status III or more
* Previous lower limb lymphedema
* Surgical contraindication to a laparoscopic approach or lymphadenectomy at surgeons discretion.
* Anesthesiologic contraindication to a laparoscopic approach at the anesthetist's discretion
* Locally advanced disease or intraabdominal/distant metastases at preoperative CT, MRI or ultrasonography
* Radiologically suspect pelvic nodal metastatic disease according to the RECIST criteria (\>= 1 node with \>=16 mm short axis diameter)
* Allergy to Iodine
* Patients with a known liver disease
* Patients with a significant bleeding disorder or mandatory antithrombotic treatment.

Primary outcomes:
measure: Sentinel node detection in cervical cancer; Sensitivity and negative predictive values for identifying pelvic nodal disease, See detailed study protocol
timeFrame: 4-5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of Gynecology and Obstetrics
Study officials:
affiliation: Region Skane
name: Jan Persson, ass professor
role: PRINCIPAL_INVESTIGATOR
References: