louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04664868: SphinkeeperTM Procedure for Treating Severe Faecal Incontinence
Official title: SphinkeeperTM Procedure for Treating Severe Faecal Incontinence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Faecal Incontinence
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Candidates for sphinkeeper operations due to fecal incontinence will be enrolled in this study.

Brief summary: Patients, aged 18 - 90 years, undergoing sphinkeeper operation at the Department of General Surgery at the Medical University of Vienna are enrolled into our study. Primary endpoints is the functional outcome as well as movement, migration and extrusion of sphinkeeper prostheses after implantation by endoluminal ultrasound and manometrical examination.

Detailed description: The Sphinkeeper™ implantation for fecal incontinence is a novel surgical procedure with limited data on its clinical efficacy. Therefore, we aimed to assess the functional outcome following Sphinkeeper™ surgery in patients with refractory FI.

Patients with FI, who met the inclusion criteria were enrolled to our study and received Sphinkeeper™ implantation. Functional outcome and quality of life was evaluated by standard questionnaires before and after surgery. In the routine check-up patients received endoanal ultrasound and anorectal manometry.

Eligibility criteria: Inclusion Criteria:

* Age 18 - 90 years, undergoing sphinkeeper operation at the Department of General Surgery, Medical University of Vienna
* Ability and willingness to understand and comply with study interventions and restrictions.
* Voluntarily signed informed consent after full explanation of the study to the participant.

Exclusion Criteria:

* Any physical or mental disorder, which could interfere with the participant's safety during the clinical trial or with the study objectives
* Inability to communicate well with the investigator due to language problems or reduced mental development
* Inability or unwillingness to give written informed consent

Primary outcomes:
measure: Faecal incontinence assessment
timeFrame: six months
Secondary outcomes:
measure: Psychological und physical well-being
timeFrame: six months
measure: Migration of Sphinkeeper prostheses
timeFrame: six months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna, Head of Pelvic Floor surgery
name: Stefan Riss, Prof.MD
role: STUDY_CHAIR
References:
Clinical trial NCT03897868: A Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension
Official title: A Muticenter, Randomized, Double-blind, Parallel, Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2019-04-01
Enrollment: 248
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter, randomized, double-blind, parallel, phase 2 study to assess dose-response relationship of HCP1803 in patients with essential hypertension


Eligibility criteria: Inclusion Criteria:

* Patient with essential hypertension who meet 140 mmHg ≤ mean sitSBP \< 180 mmHg and mean sitDBP \< 110 mmHg at Visit 1, Visit 2

Exclusion Criteria:

* Patient with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1
* Patient with difference of ≥ 15 mmHg in mean sitSBP between Visit 1 and Visit 2
* Patient with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg at Visit 1, Visit 2
* Patient with secondary hypertension

Primary outcomes:
measure: Change from baseline in sitting systolic blood pressure
timeFrame: baseline, 8 weeks
Secondary outcomes:
measure: Change from baseline in sitting systolic blood pressure
timeFrame: baseline, 4 weeks
measure: Change from baseline in sitting distolic blood pressure
timeFrame: baseline, 4 weeks, 8 weeks
measure: Proportion of subjects achieving blood pressure control
timeFrame: 4 weeks, 8 weeks
measure: Proportion of responder
timeFrame: baseline, 4 weeks, 8 weeks
measure: Change from baseline in pulse pressure(sitSBP - sitDBP)
timeFrame: baseline, 4 weeks, 8 weeks
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Donggguk University Ilsan Hospital
state: Gyeonggi-do
Study officials:
affiliation: Donggguk University Ilsan Hospital
name: Moo-Yong Rhee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hong SJ, Sung KC, Lim SW, Kim SY, Kim W, Shin J, Park S, Kim HY, Rhee MY; HM_APOLLO Investigators. Low-Dose Triple Antihypertensive Combination Therapy in Patients with Hypertension: A Randomized, Double-Blind, Phase II Study. Drug Des Devel Ther. 2020 Dec 31;14:5735-5746. doi: 10.2147/DDDT.S286586. eCollection 2020.
Clinical trial NCT05788068: Efficacy and Neuroimaging Mechanisms of Smoking Cessation in China
Official title: Efficacy and Neuroimaging Mechanisms of Smoking Cessation in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Psychological Interventions
Smoking Cessation
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This proposed project is to assess the efficacy of CBT-based digital smoking cessation interventions in China, as well as explore its neuroimaging mechanisms.


Eligibility criteria: Inclusion Criteria:

1. Use cigarettes for no less than 1 year, and use cigarettes ≥ 10 per day
2. Nicotine dependence (FTCD ≥ 3)
3. Willing to make an attempt to quit smoking in the next month, and have not quit smoking in the past 3 months, and .
4. No other addictions except nicotine
5. Education level of junior high school or above
6. Age between 18 to 45 years old
7. Right-handed
8. No contraindication of MRI scanning
9. Willing to provide informed consent to participate in the study.

Exclusion Criteria:

1. Patients who are receiving medication
2. Previous and current mental disorders,and/or mental disorders in line with DSM-5 diagnostic criteria in two departments and three generations.
3. Brain organic disease, brain injury history, coma history
4. Serious physical disease, endocrine disease history, abnormal blood picture, heart, liver and kidney function after examination
5. Pregnant and lactating women

Primary outcomes:
measure: Biochemically Validated Continuously Abstinence
timeFrame: 4 weeks
measure: Brain Structural Characteristics
timeFrame: 4 weeks
measure: Brain Functional activity
timeFrame: 4 weeks
Secondary outcomes:
measure: Self-reported 7-day Point Abstinence
timeFrame: 4 weeks
measure: Self-reported Continuous Abstinence
timeFrame: 4 weeks
Other outcomes:
measure: Smoking Reduction and Participation
timeFrame: 4 weeks
Locations:
city: Hanzhou
country: China
facility: Yanhui Liao
state: Zhejiang
Study officials:
References:
Clinical trial NCT00837668: Stromal Gene Expression During Pulmonary Sarcoidosis
Official title: Stromal Gene Expression During Pulmonary Sarcoidosis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sarcoidosis
Keywords: sarcoidosis
stromal gene expression
pulmonary sarcoidosis
bronchoscopy
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2009-02-05
Enrollment: 110
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: patients from sarcoidosis clinic

Brief summary: to determine the genetic pathways operating at the tissue level to cause granulomatous inflammation in the lungs and lymph nodes of patients with sarcoidosis. By so doing, we hope to identify unique genetic mechanisms which will aid in the diagnosis of sarcoidosis and will help us understand the pathogenesis of this poorly understood disease.

Detailed description: to collect small sample of lung tissue recovered from a clinical procedure such as bronchoscopy, or a mediastinoscopy (a procedure in which a lighted instrument (mediastinoscope) is inserted through a neck incision to visually examine the structures in the top of the chest cavity and to take a sample (biopsy) of tissue.

Eligibility criteria: Inclusion Criteria:

* diagnosis of sarcoidosis

Exclusion Criteria:

* inability to provide consent

Primary outcomes:
measure: To Identify Gene Expression Patterns That Specifically Correlate With Active Pulmonary Sarcoidosis.
timeFrame: end of study
Secondary outcomes:
measure: To Determine if Gene Expression Patterns Correlate With The Severity of Illness Of Sarcoidosis Patients
timeFrame: end of study
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Elliott Crouser, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01651468: The Effect of the Nutraceutical "Hemofix" on the Coagulation System
Official title: Phase 1 Study of the Nutraceutical "Hemofix" Safety and Effect on the Coagulation System
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Von Willebrand Disease
Menorrhagia
Keywords: mild bleeding disorder
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: HEMOFIX
name: Yocheved Grossman
name: Idan Grossman
First posted: 2012-07-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hemofix is a herbal formula based on traditional Jewish and far eastern medicine created to assist in wound healing and bleeding arrest. It contains herbs such as Red Clover, Liquorice, Raspberry, Ginger and more. The present study will evaluate the formula on the coagulation system.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers and volunteers with a mild bleeding disorder

Exclusion Criteria:

* people with thrombophilic and cardiovascular complications,
* people who are treated with anti-coagulants,
* women taking birth control pills
* people with a history hypercoagulability

Primary outcomes:
measure: bleeding and blood test results
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: HMO
name: David Varon, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03271268: Cardiovascular Biomarkers and Lung Edema in Severe Burns Patients
Official title: The Role of CARdiovascular biOmarkers (NT-pro-BNP and CD146) in Predicting Lung Edema in Severely Burned Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Burns
Keywords: Vascular filling
Fluid overload
Biomarkers
Lung edema
Lead sponsor: Saint-Louis Hospital, Paris, France
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 36
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: Severely ill burn patients admitted to a tertiary referral burn center

Brief summary: Burn injury leads to hypovolemic then distributive shock. Fluid resuscitation remains the cornerstone of initial treatment of burn shock. However, fluid rescucitation can lead to fluid overload, which manifests most notably as lung edema.

The peptide NT-pro-BNP, a biomarker of cardiac congestion secreted by the myocardium, as well as plasma CD146, an endothelial factor involved in angiogenesis and a marker of vascular congestion, may help identifying patients with risk of pulmonary edema and hypoxia .

Our hypothesis is that these biomarkers may predict the occurence of pulmonary edema in severe burns patients.


Eligibility criteria: Inclusion Criteria:

* Intubated mechanically-ventilated patients within the first 24 hours of admission
* And/or patients with total body surface area (TBSA) burn-injured \>20 %
* And/or patients with at least 10% full-thickness burns
* And/or receiving vasopressors within the first 24 hours of admission
* And monitored by a PiCCO system (PiCCO-2 Pulsion Medical Systems AG, Munich, Germany)

Exclusion Criteria:

* Admission delay to ICU \> 24 hours post burn
* Age less than 18 years
* Pregnancy
* Chronic renal impairment with a baseline eGFR \< 15 ml/min
* Patients with chemical or electrical burns
* Coexisting non-burn trauma
* Patients moribund on admission or dead within 72 h from admission
* Patients with do-not-resuscitate orders

Primary outcomes:
measure: Lung edema
timeFrame: During the first 7 days of admission
Secondary outcomes:
measure: Hypoxemia
timeFrame: During the first 7 days of admission for mechanically-ventilated patients
measure: Hypercapnia
timeFrame: During the first 7 days of admission for mechanically-ventilated patients
measure: Corrected minute ventilation > 10L/min
timeFrame: During the first 7 days of admission for mechanically-ventilated patients
measure: Multiple organ dysfunction syndrome (MODS)
timeFrame: During the first 7 days of admission
measure: 28-day mortality
timeFrame: 28 days
measure: 90-day mortality
timeFrame: 90 days
measure: Length of stay in the ICU
timeFrame: until 90 days of hospitalization
Other outcomes:
Locations:
city: Paris
country: France
facility: Sabri SOUSSI
state: Ile de France
Study officials:
affiliation: Saint-Louis Hospital, Paris, France
name: Sabri Soussi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05700968: Turkish Version of Multidimensional Outcome Expectations For Exercise Scale (MOEES
Official title: Investigation of the Validity and Reliability of the Turkish Version of Multidimensional Outcome Expectations For Exercise Scale (MOEES)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Health Care Acceptor Health Knowledge, Attitudes, Practice Patient Participation
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
Collaborators: name: İrem Hüzmeli
First posted: 2023-01-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with cardiac disease.

Brief summary: The Multidimensional Outcome Expectations For Exercise Scale (MOEES) was developed to assess the multidimensional outcome expectations of exercise. The Turkish validity and reliability study of the scale, originally in English, has not been conducted before. The aim of this study is to develop the Turkish version of the Multidimensional Outcome Expectations For Exercise Scale (MOEES), and to report its reliability assessment.

Detailed description: The Turkish version of The Multidimensional Outcome Expectations For Exercise Scale (MOEES) will be asked face to face with patients diagnosed with cardiac disease.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years.
* Be diagnosed with heart disease.
* Having at least one of the cardiac risk factors (hypertension, diabetes mellitus, hyperlipidemia/dyslipidemia, overweight or obesity (BMI\>25), physical inactivity (less than 150 minutes of moderate-intensity exercise per week).
* To agree to participate in the study.
* Being able to write and speak in Turkish.

Exclusion Criteria:

* \< 18 years.
* Lack of cooperation.
* No heart disease.
* Mental retardation.

Primary outcomes:
measure: Reliability and Validity of MOEES by Correlation Analysis.
timeFrame: 6 months
Secondary outcomes:
measure: Tampa Scale of Kinesiophobia for Heart
timeFrame: 6 months
measure: International Physical Activity Questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Mustafa Kemal University
name: Yusuf Ziya Arslan, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mustafa Kemal University
name: İrem Hüzmeli, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06128668: The Effect of Yoga on Sleep Quality, Fatigue and Physical Activity Level of Multiple Sclerosis
Official title: The Effect of Yoga on Sleep Quality, Fatigue and Physical Activity Level of Multiple Sclerosis Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Fatigue
Sleep Quality
Yoga
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is an experimental study with pre-test and post-test control groups
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized controlled study will be conducted to examine the effects of Yoga on Sleep, Fatigue and Physical Activity in Individuals Diagnosed with Relapsing-Remitting Multiple Sclerosis.


Eligibility criteria: Inclusion Criteria:

Patients diagnosed with Relapsing-Remitting Multiple Sclerosis Being an adult between the ages of 18-65

Exclusion Criteria:

* Those who have communication problems Those with psychiatric problems Having a condition that prevents you from doing yoga

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: Six week
measure: Fatigue Severity Scale:
timeFrame: six week
measure: Expanded Disability Status Scale (EDSS, ExpandedDisabilityStatusScala):
timeFrame: six week
measure: International Physical Activity Questionnaire (IPAQ):
timeFrame: six week
Secondary outcomes:
Other outcomes:
Locations:
city: Elazığ
country: Turkey
facility: Gülcan Bahçecioğlu TURAN
Study officials:
References:
Clinical trial NCT00949468: Microbiological Keratitis in a Countryside City of Brazil
Official title: Epidemiologic Characteristics, Predisposing Factors and Microbiological Profile of Infectious Corneal Ulcers in Two Referral Centers in a Countryside City of Brazil
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratitis
Keywords: Keratitis
Lead sponsor: Sao Jose do Rio Preto Medical School
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2009-07-30
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 37 patients admitted in two referral ophthalmology centers in a countryside city of Brazil. 37 volunteers were used as a control group.

Brief summary: The purpose of this study is to identify the predisposing factors, epidemiological features and clinical and microbiological diagnosis of infectious keratitis in two public referral centers of ophthalmology in a countryside city of Brazil.


Eligibility criteria: Inclusion Criteria:

* All patients admitted with clinical suspicious of keratitis from June 2008 to June 2009 (Keratitis group)
* 37 volunteers without any ophthalmologic claim, recruited in the two ophthalmology centers listed (Control study group)

Exclusion Criteria:

* In the Control Study Group, no infectious ocular disease was accepted

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Jose do Rio Preto
country: Brazil
facility: Sao Jose do Rio Preto University
state: Sao Paulo
Study officials:
affiliation: Sao Jose do Rio Preto Medical School
name: Thiago Lo Genaro, Academic
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04181268: ROtational Atherectomy, Lithotripsy or LasER for the Treatment of CAlcified STEnosis
Official title: Roller Coaster Trial: Rotational Atherectomy, Lithotripsy or LasER for the Treatment of CAlcified
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2019-11-29
Enrollment: 150
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: Some data exist about the efficacy and safety of rotational atherectomy, intravascular lithotripsy and excimer laser to modify calcified plaques.

However there is no direct randomized comparison between these three tools in this scenario.

The aim of this pilot randomized trial is to compare the safety and efficacy of these three techniques during PCI of moderate to severe calcified lesions.

Detailed description: Some data exist about the efficacy and safety of rotational atherectomy, intravascular lithotripsy and excimer laser to modify calcified plaques.

However there is no direct randomized comparison between these three tools in this scenario.

The aim of this pilot randomized trial is to compare the safety and efficacy of these three techniques during PCI of moderate to severe calcified lesions.

The primary endpoint will be the percentage of stent expansion measured with optical coherence tomography. Between secondary endpoints we will analyze the strategy success (defined as successful stent delivery and expansion with \<20% residual stenosis and TIMI 3 flow without crossover or stent failure) and presentation of clinical adverse at 1 year follow-up .

Eligibility criteria: Inclusion Criteria:

* Patients \>18 years.
* Stenosis ≥70% in a coronary artery with a diameter ≥2,5 y ≤4 mm.
* Moderate to severe angiographic calcification
* Stable coronary artery disease or NSTEMI.
* Native coronary vessel or bypass graft.

Exclusion Criteria:

* Knwon allergies to aspirin or P2y12 inhibitors.
* STEMI.
* Cardiogenic shock at the time of PCI.
* Treated lesion in a bifurcation with side branch diameter \> 2mm.
* Absence of informed consent.
* Impossibility for 1year follow up.

Primary outcomes:
measure: Percentage of stent expansion by optical coherence tomography
timeFrame: At the end of percutaneous coronary intervention
Secondary outcomes:
measure: Strategy success rate
timeFrame: At the end of percutaneous coronary intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: La Paz University Hospital
Study officials:
References: