cyrilzakka/clinical-trials huggingface dataset:
A Randomized Controlled Trial to Test the Effect of a Smartphone Quit Smoking Intervention on Young Adult Smokers

The primary aim of this study will be to determine the effectiveness of a smartphone delivered app for young adult smokers on quitting smoking.

The principle study purpose of the randomized controlled trial is to determine the effectiveness of a smartphone delivered app for young adult smokers on smoking cessation at six months using a randomized controlled trial. Secondary aims of this study include examining: 1) proximal outcome measures of cessation behaviour; 2) satisfaction, extent of app use and use of NRT and other cessation services; 3) mediators of cessation outcomes between conditions; and 4) the incremental cost-effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Age 19 to 29 years
* Currently smoking cigarettes daily or occasionally
* Residing in Canada
* Considering quitting smoking in the next 30 days
* Have an Android or iPhone OS smartphone
* Able to provide informed consent
* English comprehension
* Not referred by a study participant

Exclusion Criteria:

- opposite of the above
A Phase I Study to Investigate the ADME of KD101

A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of KD101 in Male Subjects

A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of KD101 in Male Subjects

Eligibility Criteria:
Inclusion Criteria:

* Are able to provide written informed consent
* The subject is a healthy Korean aged 20 to 55 years, inclusive.
* The subject weighs at least 55 and has a body mass index (BMI)over 27

Exclusion Criteria:

* Subjects with evidence or a history of clinically significant pulmonary, cardiovascular, hepatic, endocrine, hematological, neurologic or psychiatric diseases.
* Subjects with evidence of gastrointestinal disease which can affect the absorption of drug.
* Subjects with a history of drug abuse or a positive result in the urine drug screening for drug abuse
* Subjects who have taken any prescribed medicine or herbal medicine within 2 weeks before the first administration of the investigational product, any non-prescribed medicine or vitamin supplement within 1 week prior the first administration of the investigational product (if all other conditions are satisfied, subjects may be eligible for the trial as judged by the investigator.)
* Subjects who have donated a unit of whole blood within 30 days or who have participated in any other clinical trial within 60 days prior the first administration of the investigational product
* Subject who have history of allergy.
* Subject who can not continue proper contraception method during study period.
* Subjects who consume more than 21 units of alcohol per week (1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the PK/PD testing period
* Subjects who are unable to abstain from smoking during the PK/PD testing period
* Subjects who are unable to abstain from grapefruit or caffeine containing food 1 day prior the first administration of the investigational product
* Subjects judged not eligible for the study after reviewing the clinical laboratory results or other reasons by the investigator.
Guided Training Program of Maximum Strength in Military Personnel

Introduction. The members of the Military Emergency Unit must be physically prepared for any type of situation where required, although their strength training does not follow any concrete structure. Structured training of maximum strength aims to increase the recruitment of different types of fibers, and the increase in the size of these.

Objectives: To evaluate the effectiveness of a maximum strength training protocol in lower extremity functionality in military personnel aged 25 to 45 years.

Study design. Randomized, single-blind clinical study with follow-up period. Methodology. 65 male subjects will be recruited, who will be randomly assigned to the two study groups: experimental (structured strength training) and control (they will continue with their usual routine of free training). The intervention will last for 8 weeks, with 2 weekly sessions, lasting 20 minutes, with three evaluations (baseline, posttreatment and follow-up). The study variables will be: lower limb functionality (assessed by Standing Long Jump and Single Leg Hop tests), and quadriceps and hamstring strength (evaluated with the MRI measurement for each exercise). To perform the analysis of normality, the Kolmogorov Smirnof test will be used. In case of homogeneity, with the t-student test of repeated measures and an ANOVA of repeated means, the difference between the different evaluations and the intra and intersubject effect, respectively, will be calculated.

Expected results. Effectiveness of structured training of maximum strength in functionality of lower extremities.


Eligibility Criteria:
Inclusion Criteria:

* Military personnel belonging to the Military Emergency Unit
* male
* With an age of 25 to 45 years
* No history of musculoskeletal injury in the 3 months prior to the study

Exclusion Criteria:

* Present a diagnosis of injury in the period prior to or during the study
* Who are receiving a physiotherapy intervention at the time of the study
* Not signed the informed consent document
Leg Fluid Shift in Patients With Chronic Heart Failure and Obstructive or Central Sleep Apnea

This study aims to investigate the influence of a potential leg fluid shift (LFS) in patients with chronic heart failure (CHF) and obstructive sleep apnea (OSA) or central sleep apnea (CSA).

Chronic heart failure (CHF) is a common disease in general western population with high levels of morbidity and mortality. Prospective risk factors need to be identified and investigated. The prevalence for sleep disordered breathing (SDB) in patients with CHF is higher compared to general population. Especially the occurence of CSA with its special breathing pattern of Cheyne-Stokes-Respiration (CSR) is frequent in CHF patients.The pathophysiology and relation inbetween sleep apnea (SA) and CHF isn´t completely identified yet. Multiple theories with different strategies try to explain the pathophysics and development of SA. Following one of these theories, patients with CHF often develop edema in lower body compartments. The idea is a possible influence of retrograde nocturnal LFS from lower body to upper body compartments which could induce pulmonal congestion. Therefore, an increased pulmonary capillary wedge pressure (PCWP) could irritate special pulmonal receptors resulting in CSR with periods of hyperventilation, related hypocapnia and central apnea events. OSA could be induced by fluid accumulation in the upper airway by retrograde fluid shift.

Patients with known CHF receive fluid measurements by b multi frequency bioimpedance analysis (mfBIA) the evening before and the morning after sleep is recorded using polygraphy (PG) or polysomnography (PSG) in hospital. Sleep results are analyzed by physicians using current guidelines of the American Academy of Sleep Medicine (AASM).

Capillary blood gas (CBG) samples are taken before and after sleep to examine the relation of fluid shift and blood gas changes.

A subgroup of the study group undergo additional investigation. Hemodynamic effects (e.g. reduced cardiac output (CO)) as a cause of a potential fluid shift is measured during wakefulness by using a tilting table. Hemodynamically relevant parameters are recorded non-invasively.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Heart Failure
* reduced left ventricular ejection fraction (LVEF) ≤ 45%
* NYHA I - IV

Exclusion Criteria:

* current existing sleep apnoea breathing therapy
* significant chronic obstructive pulmonary disease (COPD) Tiffenau-Index: \<70%
* respiratory insufficiency with need for a long time oxygen therapy
* hypercapnic state in rest at day time
* acute myocardial infarction at moment of study
* instable angina pectoris at moment of study
* cardiac surgery in last twelve weeks
* stroke or TIA in last twelve weeks
* implantable cardioverter-defibrillator, if there is no security clearance of the fabricator
* chronic kidney disease \> Stage III
Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes

To prospectively observe the outcomes of surgical prolapse treatment in terms of urinary, bowel, and sexual function, quality of life, patient satisfaction, cost, and achieving patient determined treatment goals.

Patients meeting the inclusion/exclusion criteria will be identified by reviewing the hospital's surgical boarding list and contacted by phone to obtain informed consent. Once informed consent is obtained, chart review will be conducted here at William Beaumont Hospital and at the physician's office to collect patient information related to their prolapse condition. Prior to surgery, questionnaires will be mailed and completed by the participant and then again at 6 and 12 months after surgery, and then yearly. Questionnaires will assess urinary, bowel, and sexual function, and patient treatment goals, treatment satisfaction, and general health and wellbeing. Completion of the questionnaires will be voluntary, and participants will be followed in this manner until voluntary withdrawal, exclusionary criteria emerge, or death.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Pelvic Organ Prolapse
* Able to provide informed consent
* Able to complete study assessments, per clinician judgment

Exclusion Criteria:

* Age \< 21 years
* Currently pregnant or \< 6 months post-partum
Safety and Efficacy of Formulation for Improving Vagina Laxity: A Pilot Study

This study is conducted to investigate the safety and efficacy of the formulation containing stem cell secretome and licorice root extract in improving vagina laxity (VL) condition of women in Malaysia. This formulation may stimulate cell rejuvenation and trigger cell renewal efficiently as they contained rich mixture of natural, bioavailable polypeptides and plant extracts and these might help improving the VL condition in women. The study duration is 5 weeks and vagina assessment will be carried out at baseline, week 2 and week 5.The main objectives of this study are:

1. To assess the vagina laxity of women in Malaysia after using the formulation.
2. To observe any adverse effect occurrence with the use of the formulation.


Eligibility Criteria:
Inclusion Criteria:

* Malaysian women ( age 40 to 55 years old)
* Complaint of vagina laxity
* Willingness to participate in the study

Exclusion Criteria:

* Pregnant and breastfeeding women
* Doing any surgical or non-surgical procedures to improved vaginal laxity condition such as laser and radiofrequency before participating in the study that might affect the study outcome
* Presence of illness or taking any medication that might impact the study outcome or participants well-being
Validation of HRM Score for the GERD Diagnosis

The goal of this prospective study is to validate a high resolution manometry score to predict pathologic GERD in patients with reflux symptoms. The main question it aims to answer is:

Is it possible to predict GERD on high resolution manometry? Participants will be asked to undergo high resolution manometry and pH-study

According to recent guidelines, high resolution manometry (HRM) has an ancillary role in the diagnosis of gastro-esophageal reflux disease (GERD). A recent multicenter study demonstrated the effectiveness of the straight leg raise (SLR) maneuver in predicting GERD, thus increasing the diagnostic value of HRM in patients with suspected pathological reflux. HRM parameters associated with GERD include esophageal body hypomotility such as ineffective esophageal motility (IEM), and esophagogastric junction (EGJ) metrics, particularly the EGJ contractile integral (EGJ-CI) that takes into consideration the presence or absence of a hiatal hernia (HH), and a hypotensive lower esophageal sphincter (LES). The combination of these four parameters might help to predict or exclude true GERD in patients undergoing HRM with the suspicion of GERD.

In this multicenter international prospective study, we aimed to build a score to predict pathological esophageal acid exposure time (AET\>6%).

Eligibility Criteria:
Inclusion Criteria:

* HRM and wireless pH-study or catheter pH-impedance study performed for persistent GERD symptoms off proton-pump inhibitor (PPI) within two weeks of each other,
* SLR maneuver performed at the end of HRM

Exclusion Criteria:

* Body mass index (BMI) \>35 Kg/m2
* prior esophageal surgery
* paraesophageal hiatal hernia
* eosinophilic esophagitis
* scleroderma
* esophageal achalasia
Evaluation of Vaccination Coverage and Determinants of Success of the COVID-19 Vaccination Program Among Populations in Very Precarious Situations

The main objective of the study is to assess the level of vaccination coverage (VC) against COVID-19 among migrants, homeless and travelling community, according to their living conditions and housing.

The secondary objectives are :

* to compare the estimated level of vaccination coverage in the different sites and strata (emergency shelters/hotels, camps, workers' hostels, on the street) with the estimated level in the general population of the same territory obtained from the French Health Insurance data (SIVAC).
* identify the obstacles and leverage of vaccination (i.e. mobile team) according to living conditions and habitat (socio-demographic factors, personal health history, vaccine adherence, local health policies, etc.).


Eligibility Criteria:
Inclusion Criteria:

* Adult (18 years and older)
* People considered as homeless (homeless, living in a camp or squat) or
* Living in adapted housing (migrant workers' hostel) or
* Housed in residences of the National System or
* Housed in a social residence such as a 115 hotel or a social housing centre
* Freely and voluntarily consenting to participate

Exclusion Criteria:

* Refusal to participate in the study (non-consent).
* Language barrier with no in-person or telephone translation available.
* Impossibility to give free and informed consent (comprehension barrier, cognitive and/or psychiatric and/or addictive disorders, external pressure from family and friends, persons under guardianship, etc.).
The Effects of Surgical Wait Time for Knee Arthroplasty Quality of Life in Patients Awaiting Knee Arthroplasty

This study prospectively evaluates the effect of surgical wait time on knee function, pain and quality of life in patients waiting for knee arthroplasty (TKA or PKA)

Osteoarthritis (OA) is a common condition, leading to pain and disability. The knee is the most affected joint, accounting for almost 80 percent of the total prevalence of OA. The pooled global prevalence of knee OA is 22.9% in individuals aged 40 and over. Correspondingly, there are around 654.1 million individuals with knee OA in 2020 worldwide. The number of people affected with symptomatic knee OA is likely to increase because of the aging population and the obesity epidemic.

Pain is the most important symptom in knee OA. It is intermittent, typically weight bearing and progressive over time. Additional symptoms are crepitus, swelling and morning stiffness. The knee is often swollen and has diminished range of motion (ROM). Not only does OA lead to functional disability, but also influences social participation and quality of life.

Knee OA is a progressive disease, which requires continuous management. Treatment consists of conservative as well as invasive treatments, as described in national and international guidelines. First line treatments are patient education, physical therapy, weight loss, different pharmacological treatments and intra-articular steroid injections. More advanced OA may require surgery. Knee arthroplasty, (total knee arthroplasty (TKA) or partial knee arthroplasty (PKA)) can provide excellent pain relief, remarkable deformity correction, and satisfactory functional recovery.

Since the beginning of the covid19 pandemic, surgeons have been asked to only perform essential surgeries in order to preserve healthcare resources. This has led to an increase in patients on the waiting list, resulting in unusually high wait times. Despite the decrease in covid related healthcare consumption, waiting times are yet to return to pre-covid duration. Currently, time to surgery in our hospital is approximately 7 months as opposed to 2-3 months pre-covid.

Long wait times may be a substantial burden for patients. There have been reports of worsening pain, deterioration in quality of life and increased opioid use and frailty. The effects on pain catastrophizing, fear and anxiety have not yet been studied.

It is important to better understand the effects of long surgical wait times on pre-operative knee function, pain and quality of life as well as to investigate how this effects outcome after surgery.

Eligibility Criteria:
Inclusion Criteria:

* on the waiting list for partial or total knee arthroplasty
* written informed consent

Exclusion Criteria:

* none
Prevalence and Dynamic of Sleep-disordered Breathing in Patients Pre and Post Heart Transplantation

Sleep-disordered breathing is believed to appear at a high prevalence in end-stage heart failure patients and the presence of sleep-disordered breathing has been associated with increased mortality. This study is designed to investigate prevalence and dynamics of sleep-disordered breathing in end-stage heart failure patients pre and post heart transplantation.

Sleep-disordered breathing is believed to appear at a high prevalence in end-stage heart failure patients and the presence of sleep-disordered breathing has been associated with increased mortality. This study is designed to investigate prevalence and dynamics of sleep-disordered breathing in end-stage heart failure patients pre and post heart transplantation, as this topic is hardly studied yet and previous reports suggest changes in the entity of sleep-disordered breathing through heart transplantation. The circumstances and the impact of sleep-disordered breathing or residuals in heart transplant patients is not well understood yet and will be subject of this study.

Eligibility Criteria:
Inclusion Criteria:

* End-stage heart failure patients assigned and eligible for heart transplantation

Exclusion Criteria:

* heart failure patients not eligible for heart transplantation
Telemedicine for Patients With an Hybrid Closed Loop System

The primary objective is to assess the impact on quality of life after a follow-up program using a telemedicine platform designed for patients with DM1 treated with an hybrid closed loop insulin infusion system. Open-label, randomized 1:1 controlled clinical trial during 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Diagnostic criteria for DM1 according to ADA
* They must have access to the technology that allows monitoring (mobile phone and / or computer as well as having an internet connection)
* Acceptance of participation in the study and signing of the informed consent

Exclusion Criteria:

* Gestation
* Institutionalization, serious or terminal illness or renal replacement therapy.
* Inability to undertake the training and / or acquire the degree of knowledge to use the telemedicine platform.
* Refusal to participate in the study or to sign the informed consent
TEAS Reduces Remifentanil Consumption

Transcutaneous electrical acupoint stimulation (TEAS) has been shown to decrease the need of opioids including remifentanil during anaesthesia. However, it is not clear whether combination of two or more acupoints could induce stronger analgesia. Moreover, evidence for the long-term effect of TEAS has been limited. The present study was to compare the short-term and long-term effect on pain of dual-acupoint and single-acupoint TEAS.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 yrs
* body mass index (BMI) of 18 to 30 kg/m2
* elective radical mastectomy under general anaesthesia

Exclusion Criteria:

* contradictions to TEAS
* difficulties in communication
* histories of general anaesthesia
* drug or alcohol abuse or addiction
* cardiac dysfunction or severe hypertension
* confirmed hepatic dysfunction and renal impairment
* the participants recruited into other clinical trials during last three months
KDIGO Bundle to Prevent AKI in Sepsis

Summary: Controlled, prospective, randomized and randomized clinical trial of two intervention groups (standard care vs. preventive recommendations the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines for AKI) of patients diagnosed with sepsis and abdominal post-surgical septic shock with positive results in the risk determination of acute renal injury by NephroCheck® Test that integrates the urinary biomarkers TIMP-2 and IGFBP-7.

Hypothesis: The implementation of a package of preventive measures proposed by the KDIGO guide can reduce the occurrence and severity of acute renal injury in the high-risk abdominal post-surgical septic patient detected by urinary biomarkers for early detection.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years.
* Patients (or their informed family members) who accept and sign the informed consent.
* Patients diagnosed with sepsis or abdominal post-surgical septic shock.

Exclusion Criteria:

* Patients under 18 years.
* Patients (or their authorized relatives) who refuse to sign the informed consent.
* Patients diagnosed with sepsis or non-surgical septic shock.
* Patients diagnosed with sepsis or septic shock of origin other than abdominal.
* Patients with AKI stages KDIGO 2 and 3 and / or renal replacement therapy.
* Patients with chronic renal failure and glomerular filtration \<30 ml / min and / or undergoing treatment with dialysis or previous renal transplantation.
* Patients with AKI of origin other than the diagnosed septic, such as glomerulonephritis or interstitial nephritis, renal artery occlusion and / or postrenal obstruction.