louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04673331: Physical Activity, Exercise Capacity and Coronavirus Phobia of Adult Cystic Fibrosis Patients During COVID-19 Pandemic
Official title: Comparison of Physical Activity, Exercise Capacity, Quality of Life, Cognitive Function and Coronavirus Phobia Levels of Adult Cystic Fibrosis Patients With Healthy Individuals With Telerehabilitation in the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients and healthy individuals between 18-65 years old, who are diagnosed with cystic fibrosis will be included in the study.

Brief summary: The purpose of this study was to evaluate physical activity, exercise capacity, quality of life, cognitive status level and coronavirus phobia level of adult cystic fibrosis patients and compare with the findings of healthy subjects with teleconference during COVID-19 pandemic.

Detailed description: This study will be participated adult with cystic fibrosis and healthy individuals. Demographic information of individuals will be recorded in online video conference. Physical activity, exercise capacity and cognitive function levels will be measured during video conferencing.Then, the physical activity level, coronavirus phobia and quality of life of the participants will be evaluated subjectively with questionnaires through the Google forms.

Eligibility criteria: Inclusion Criteria:

* Being over 18 years old Having the ability to access the internet through a device (computer or mobile device) that enables video conferencing Giving consent on a voluntary basis

Exclusion Criteria:

* Severe comorbidity that limits mobilization or physical activity(orthopedic, cardiac or neurological condition) Pregnancy

Primary outcomes:
measure: Physical Activity Level-International Physical Activity Questionnaire
timeFrame: 8 minutes
measure: Coronavirus Phobia-Coronavirus-19 Phobia Scale
timeFrame: 5 minutes
measure: Exercise Capacity
timeFrame: 15 minutes
measure: Weekly Average Steps
timeFrame: 2 minutes
Secondary outcomes:
measure: Cognitive Function-Standardized Mini Mental State Examination
timeFrame: 5 minutes
measure: Quality Of Life-Nottingham Health Profile
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Naciye Vardar Yağlı, PhD
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Aydan Aslı Aksel
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Ebru Damadoğlu, PhD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Merve Fırat, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT06694831: Health Tourism in Bariatric Surgery
Official title: Evaluation of Anxiety of Patients Coming to Our Country for Bariatric Surgery Through Health Tourism Using Psychiatric Tests
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anxiety
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over the age of 18 who came to our country for bariatric surgery through health tourism

Brief summary: The aim of the study is to examine whether patients who come to our country for bariatric surgery via health tourism have any concerns during this process, and if they do, to determine the level of their concerns through psychometric tests, to determine the reasons for their concerns (is it related to travel, going to another country, hospital, surgery, etc.) and whether their concerns decrease after the surgery.


Eligibility criteria: Inclusion Criteria:

* Patients who came to our country through health tourism
* Patients with indications for bariatric surgery
* Patients over the age of 18

Exclusion Criteria:

* Patients under 18 years of age
* Patients with psychiatric, neurological diseases or mental retardation that prevent them from completing psychometric tests
* Patients with bariatric surgery indications other than health tourism
* Patients who do not agree to participate in the study

Primary outcomes:
measure: anxiety scale
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istinye Üniversity
state: Merkez Mahallesi
Study officials:
References:
citation: Zuberi S, Egiz A, Iqbal H, Jambulingam P, Whitelaw D, Adil T, Jain V, Al-Taan O, Munasinghe A, Askari A, Aly MK, Iqbal FM. Characterizing barriers and facilitators of metabolic bariatric surgery tourism: a systematic review. Br J Surg. 2024 Mar 2;111(3):znae060. doi: 10.1093/bjs/znae060.
citation: Demir Y, Özpınar S. Evaluation of the Effect of Body Image Perception on Patient Satisfaction and Quality of Life in Medical Tourists Undergoing Bariatric Metabolic Surgery. Int Journal Of Health Manag. And Tourism 2024, 9(1), 62-75.
Clinical trial NCT05991531: Dynamic Changes of Serum HBV RNA in Chronic Hepatitis B Patients
Official title: Dynamic Changes of Serum HBV RNA in Chronic Hepatitis B Patients With Low Level HBV DNA Treated With Nucleoside (Acid) Analogues
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Hepatitis B Patients
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 100
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 who receive antiviral therapy with nucleoside (acid) analogues for 1-3 years and with HBV DNA negative or LLV.

Brief summary: Some patients with low-level viremia (LLV) are also likely to develop hepatocellular carcinoma (HCC) or other liver diseases. The relationship between HBV RNA levels and fibrosis in patients with HBV DNA negative or LLV is still lacking evidence. The purpose of this study is to observe the differences in HBV RNA levels and their association with efficacy in HBV DNA negative or LLV patients. Investigators conduct the prospective, single-center, non-randomized, observational clinical study. A total of 100 chronic hepatitis B (CHB) patients who receive antiviral therapy with nucleoside (acid) analogues for 1-3 years will be enrolled. The enrolled patients will be followed up five times to collect clinical data and record adverse events (at baseline, week 12, week 24, week 36 and week 48, respectively).


Eligibility criteria: Inclusion Criteria:

* 1.18 years old or above and the gender is not limited;
* 2. Patients who receive antiviral therapy with nucleoside (acid) analogues for 1-3 years ;
* 3. Patients with HBV DNA negative (HBV DNA\<20 IU/ml) or LLV（HBV DNA 20-2000 IU/mL）
* 4. Good compliance and voluntary signing of informed consent.

Exclusion Criteria:

* 1. Patients with decompensated cirrhosis;
* 2. Patients co-infection with other viruses, such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, HIV virus, etc.;
* 3. Patients with significant renal, cardiovascular, pulmonary, or neurological disease;
* 4. Patients have active or suspected malignancy or history of malignancy;
* 5. Patients who were identified not appropriate for the study by investigators.

Primary outcomes:
measure: The decrease of HBV RNA from baseline to 48 weeks
timeFrame: 2023.8-2025.8
Secondary outcomes:
measure: HBV RNA undetectable rate at 48 weeks;
timeFrame: 2023.8-2025.8
measure: The association of the dynamic changes of serum HBV RNA levels with HBsAg and HBeAg levels;
timeFrame: 2023.8-2025.8
measure: The association of HBV RNA changes with the liver stiffness;
timeFrame: 2023.8-2025.8
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT03398031: Effect of Magnesium Supplement in Early Pregnancy After ICSI
Official title: Magnesium Supplement in Early Pregnancy After ICSI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: ICSI
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 180
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Daily supplement of magnesium after biochemical diagnosis of pregnancy in females pregnant after ICSI and through out 1st trimester

Detailed description: a fall of magnesium levels at 2-3 weeks of gestation. This drop of magnesium concentration is larger following IVF as compared to spontaneous pregnancies.

so magnesium supplement start after biochemical diagnosis of pregnancy and throughout the 1st trimester

Eligibility criteria: Inclusion Criteria:

* age 25_38 years
* BMI 25_30

  * females pregnant after ICSI after biochemical diagnosis of pregnancy

Exclusion Criteria:

* females with poor ovarian reserve and poor responders

  * abnormality in uterine cavity detected by hysteroscopic evaluation pre ICSI and not treated
  * hydrosalpinx

Primary outcomes:
measure: 1st trimesteric abortion
timeFrame: 13 week of gestation
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShams university maternity hospital
state: Abbassya
Study officials:
References:
Clinical trial NCT03412331: Effects Of Adjunctive Photodynamic Therapy To Non-Surgical Periodontal Treatment In Patients With Generalized Aggressive Periodontitis
Official title: Clinical And Microbiological Evaluations Of Adjunctive Photodynamic Therapy To Non-Surgical Periodontal Treatment In Patients With Generalized Aggressive Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Aggressive Periodontitis
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Generalized aggressive periodontitis (GAgP) is a distinct type of periodontal disease characterized by rapid loss of attachment and alveolar bone occuring in young individuals. Photodynamic therapy (PDT) was introduced in periodontology as an adjunctive approach to non-surgical periodontal treatment (NPT) in periodontitis patients. In this trial, it was aimed that to evaluate the clinical and microbiological effects of adjunctive PDT to NPT in patients with GAgP. In this prospective controlled clinical study, 24 systemically healthy, non-smoking subjects with GAgP were enrolled. Subjects were randomly assigned to a control group (n=12) treated with NPT only or to a test group (n=12) treated with NPT and PDT. Plaque index, sulcus bleeding index (SBI), pocket depth (PD), relative attachment level, gingival recession, mobility were recorded at baseline and on day 63. Microbiological samples were obtained fom the sites with PD ≥5 mm at the same time points and evaluated for Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia and Treponema denticola using micro-IDent test.


Eligibility criteria: Inclusion Criteria:

* systemically healthy,
* non-smoker
* not received any periodontal treatment within the last 6 months
* no antibiotics, anti-inflammatory drugs or any other medication taken within the last 6 months
* consent to participate in the study

Exclusion Criteria:

* any systemic disease (i.e. diabetes mellitus, HIV infection) that might influence the prognosis of periodontal disease and outcome of the treatment
* any medical condition that required antibiotic prophylaxis before the treatment
* smoking
* pregnancy and lactation
* ingestion of antibiotics, anti-inflammatory drugs or any other medication during study period
* any physical limitations or restrictions that might preclude normal oral hygiene procedures

Primary outcomes:
measure: Probing Depth
timeFrame: 63 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Marmara University, Faculty of Dentistry, Department of Periodontology
name: Leyla KURU, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04408131: Morbi-mortality by COVID-19 Among Homeless People in Marseille: a Cohort Study
Official title: Morbi-mortality by COVID-19 Among Homeless People in Marseille: a Cohort Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Homeless
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: COVID/Homeless is a prospective observational cohort study of homeless people to determine the impact of the SARS-CoV-2 epidemic on this population.

The cohort aims for exhaustiveness for the city of Marseille, being based on the active files of the partner teams, namely the four emergency shelters of Marseille and 12 outreach teams (including one specialized in psychiatry, three specialized in addictions, and three working in squats and shantytowns).

Aims of this cohort include to identify of the prognostic factors of morbi-mortality of homeless people by COVID-19, and therefore to propose appropriate management strategies.


Eligibility criteria: Inclusion Criteria:

* Living in the city of Marseille
* Being homeless
* Be over 18 years of age

Exclusion Criteria:

* Persons under guardianship
* Persons who refused to sign the research consent

Primary outcomes:
measure: the covid mortality rate
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
state: Paca
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Jean-Olivier ARNAUD, Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03703531: Istria County CPR Survival 2011-2017
Official title: Effect of Duration of EMS Teams' Arrival on CPR Survival in Istria County, Croatia, 2011.-2017.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiopulmonary Resuscitation
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 1440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients resuscitated in the 2011-2017 time frame in Istria county, Croatia

Brief summary: Analysis of factors that influence CPR survival of 1440 patients that were resuscitated in Istria County, Croatia between 2011-2017.

Detailed description: Survival status, duration to EMS arrival, level of education of initial CPR provider, initial monitored rhythm, cause of cardiac arrest, age, gender and time of year will be recorded and analyzed to determine which factors influence CPR survival.

Eligibility criteria: Inclusion Criteria:

* all adult patients that were resuscitated in Istria county because of out of hospital cardiac arrest (OHCA)

Exclusion Criteria:

* minors

Primary outcomes:
measure: Survival status
timeFrame: At hospital admission
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
state: Grad Zagreb
Study officials:
References:
Clinical trial NCT00640731: Safety and Efficacy Study of OmniWave Endovascular System to Treat Deep Vein Thrombosis
Official title: Study of the OmniWave Endovascular System in Subjects With Lower and Upper Extremity Deep Vein Thrombosis - SONIC I Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Deep Vein Thrombosis
Keywords: DVT
Peripheral Vascular Disease
Venous Thrombosis
Deep Vein Thrombosis
Lead sponsor: OmniSonics Medical Technologies, Inc.
Sponsor class: OTHER
First posted: 2008-03-21
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, multi-center single arm registry to assess the use of the OmniWave Endovascular System in subjects presenting with either lower or upper extremity acute (symptoms have been present for greater than or equal to 14 days) DVT.


Eligibility criteria: Inclusion Criteria:

* DVT confirmed by venographic and ultrasound imaging, which has been symptomatic for a maximum of 14 days, or diagnosed within past 14 days defined as either first episode (no prior history in affected segment), or recurrent episode.
* Written informed consent
* Agreement to comply with follow up requirements

Exclusion Criteria:

* Known R-L shunt, pulmonary A-V malformation
* Excessive tortuosity and/or sharp angulation in target treatment zone
* Isolated calf vein thrombosis
* Isolated DVT in veins peripheral to axillary vein
* Thrombus in peripheral vessel smaller than 5 mm
* Target treatment zone cannot be adequately accessed within the 100 cm working length of device

Primary outcomes:
measure: Procedural success rate defined as at least 50% reduction in thrombus burden in each target treatment zone following use of the OmniWave Endovascular System
timeFrame: Post-Index procedure
Secondary outcomes:
measure: Death, clinically detectable PE, significant vessel damage in target treatment area
timeFrame: through 6 months post-index procedure
measure: Restoration and maintenance of antegrade in-line flow in target treatment area
timeFrame: through 6 months post-index procedure
measure: QOL SF-36
timeFrame: through 6 months post-index procedure
measure: Incidence of clinically significant hemolysis
timeFrame: Prior to discharge
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: John Aruny, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02959931: Postprandial Effects of a High Potassium Meal
Official title: Postprandial Physiological Effects of a High Potassium Meal in Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Dietary Potassium
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators aim to evaluate the acute effects of potassium supplementation achieved by ingestion of potassium rich food, on vascular health.

Detailed description: Many studies have shown that an increase in potassium through the diet or through potassium pills helps to lower blood pressure. Also, the amount of oral potassium taken can improve how well the participants blood vessels work. These studies have focused on potassium given in the form of a pill. The investigators are interested in the effect of potassium consumed through food sources and how it will effect arterial health and blood pressure. The world health organization (WHO) recommends a K⁺ intake of at least 3510 mg/day from food for adults, excluding those with impaired K⁺ excretion. In this study the investigators aim to provide approximately 75% (approximately 2000 mg) of the total daily recommended intake for potassium in one meal. The investigators do not know whether dietary potassium (not pill form) will acutely improve the arterial health and if it will cause a decrease in blood pressure. The investigators hypothesis to see an improvement in vascular function following a high potassium meal compared to a low potassium meal.

Eligibility criteria: Inclusion Criteria:

* 18-80 years
* Normal sinus rhythm
* A diagnosis of hypertension on medical therapy with an ambulatory systolic blood pressure \<160 mmHg and diastolic blood pressure \<90 mmHg, or a diagnosis of stable coronary artery disease

Exclusion Criteria:

* Recent hospital admission due to an cardiovascular events
* Serum K+ concentration \>5.0 mmol/L
* Current smoking
* Women who are pregnant
* Diabetic patients - patients receiving insulin therapy
* Glomerular filtration rate \< 90mls/min/1.73m2
* On loop diuretic therapy
* Food allergies and/or intolerance to meal items

Primary outcomes:
measure: Change in Flow Mediated Dilatation
timeFrame: Flow Mediated Dilatation will be assessed over 2 clinic visits, at 3 times points with in each visit; pre-prandial and post-prandial at 60 min and 120 min
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT06174831: Study of a Series of Patients Treated for Retrograde Cricopharyngeal Muscle Dysfunction Syndrome
Official title: Study of a Series of Patients Treated for Retrograde Cricopharyngeal Muscle Dysfunction Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Deglutition Disorders
Keywords: Deglutition Disorders
Dysphagia
cricopharyngeus muscle
Circular sphincter
Esophagus
Botulinum toxin
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major Subject treated by injection of botulinum toxin into the cricopharyngeal muscle after having had a diagnosis of R-CPD in consultation between January 1, 2022 and December 31, 2022

Brief summary: R-CPD syndrome (Retrograde Cricopharyngeal Dysfunction syndrome) is an inability to burp.

It is a syndrome whose diagnosis is clinical, and for which there is effective treatment. Recently treated in the United States (first publication in 2019), this syndrome affects many patients in France and is currently unknown.

This study concerns a series of patients treated at the University Hospitals of Strasbourg for a syndrome of retrograde dysfunction of the cricopharyngeus muscle having been treated by injection of botulinum toxin into the cricopharyngeus muscle.


Eligibility criteria: Inclusion Criteria:

* Major subject (≥18 years old)
* Subject treated by injection of botulinum toxin into the cricopharyngeal muscle after having had a diagnosis of R-CPD in consultation between January 1, 2022 and December 31, 2022
* Subject not opposing the reuse of their data for the purposes of this research.

Exclusion Criteria:

* Subject having expressed opposition to participating in the study,
* Subject under judicial protection
* Subject under guardianship or curatorship

Primary outcomes:
measure: Retrospective description of the characteristics of a series of patients treated for dysphagia syndrome
timeFrame: Through study completion, an average of 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'ORL et de Chirurgie Cervico-faciale - CHU de Strasbourg - France
Study officials:
References: