cyrilzakka/clinical-trials huggingface dataset:
Testing the Impact of Smartphone-based Messaging to Support Young Adult Smoking Cessation

Clinical practice guidelines for smoking cessation emphasize cognitive behavioral therapy (CBT) to help patients develop coping strategies for urges. Mindfulness or Acceptance and commitment Therapy (ACT) offer a different approach, which teaches smokers psychological flexibility through accepting negative experiences. While there is evidence for the efficacy of both CBT and Mindfulness/ACT smoking cessation interventions, it is unclear if these approaches are efficacious when implemented in real-time and with young adults. The overall goal of this proposal is to evaluate the efficacy of CBT and Mindfulness/ACT messages for young adults targeted at specific high-risk situations for smoking.

To conduct a pilot trial to test CBT and Mindfulness/ACT intervention message efficacy for reducing momentary smoking urges (N=10). To inform just-in-time interventions, it is crucial to test if CBT and Mindfulness/ACT based messages can reduce momentary smoking urges. The investigators will conduct a micro-randomized trial (repeated within-subject randomizations of messages) to accomplish this. In line with the investigators' existing protocol, participants first collect Ecological Momentary Assessment (EMA) data for 14 days, allowing the investigators to determine high-risk situations for smoking. In the following intervention phase, participants receive tailored messages triggered by geofencing of participants' high-risk locations for a total of 30 days. Tailoring is based on established predictors of smoking relapse (stress and presence of other smokers). The micro-randomized trial tests the efficacy of CBT versus Mindfulness/ACT versus control messages for reducing smoking urge 15 minutes post message delivery. Secondary outcomes include smoking or other tobacco use (including e-cigarettes), affect, and stress. After 45 days, follow up interviews with participants will be conducted to collect information on their study experience.

Eligibility Criteria:
Inclusion Criteria:

1. live in the U.S.
2. read English;
3. are between 18 and 30 years of age;
4. own an iPhone or Android smartphone;
5. have smoked ≥100 cigarettes and currently smoke at least 1 cigarette per day on 3 or more days of the week;
6. are planning to quit smoking within the next 30 days.

Exclusion Criteria:

* live internationally
* don't read English
* younger than 18, older than 30
* don't own a iPhone or Android smartphone
* have smoked less than 100 cigarettes
* not planning to quit smoking in the next 30 days
Effect on Glycemic Control of Inhaled Insulin Alone or Added to Dual Oral Therapy After Failure of Dual Oral Therapy.

To assess the impact on glucose control by inhaled insulin alone or added to two oral anti-diabetic agents in patients with type 2 diabetes who are not well controlled on 2 oral anti-diabetic agents.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus as defined by American Diabetes Association (ADA) at least 1 year earlier.
* Patients were required to have been treated with a stable oral agent regimen involving 2 antidiabetc medications: 1 insulin secretagogue (a sulfonylurea or replabinide) and 1 insulin sensitizer (a thiazolidinedione or metformin).

Exclusion Criteria:

* Asthma, COPD
* Smoking during the previous 6 months
Post Marketing Surveillance(PMS) Study of Lorviqua in Korea

The objective of this study is to monitor the usage of Lorviqua in real practice within label, including the adverse events associated with Lorviqua


Eligibility Criteria:
Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. Use in the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC)
2. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

Patients meeting any of the following criteria will not be included in the study:

1. Patients to whom Lorviqua® is contraindicated as per the local labeling. A. Hypersensitivity to Lorviqua® or to any of the excipients of this product B. Lorviqua® is contraindicated in patients taking concomitant use of strong CYP3A4/5 inducers C. This medicinal product contains lactose as an excipient. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose galactose malabsorption should not take this medicinal product.
2. Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information
Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients

To compare the efficacy of three different long-term treatment strategies of reflux disease in primary care setting.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who seek medical advice in primary care for symptoms thought to be GERD related (GERD is a condition which develops when the reflux of stomach content causes troublesome symptoms and / or complications).

Exclusion Criteria:

* Subjects with any clinical GERD treatment (PPI, H2-receptor antagonists) within the last 3 months prior to Visit 1.
* A history of severe esophagitis or known other complications, with alarm symptoms
Impact Evaluation of Triggerise's Tiko Platform

Triggerise designed web and phone based Tiko platform to connect young girls and women to the health products, services and information. The platform uses principles of behaviour economics to motivate positive choices-including rewards, promotions, discounts, coupons, reminders, alerts etc. The platform was implemented in several cities from seven states of India to provide Sexual Reproductive Health (SRH) and maternal and child health (MCH) products and services. The consumers (called Rafikis) use Tiko card to get discounts and to earn 'Tiko miles' rewards at Tiko franchised healthcare providers and pharmacies. Tiko miles are redeemable towards lifestyle products or services (e.g., beauty salons). The local Tiko health promoter (celled Pro agent) can also buy health and hygiene products at bulk discounts and sell them at profit.

Triggerise appointed Network for Engineering, Economics Research and Management (NEERMAN) to conduct an independent impact assessment of the Tiko platform with multiple research objectives include health impact evaluation at the Rafiki level.

NEERMAN used an ex-post observational design to compare usage of SRH and MCH services and family planning (FP), antenatal care (ANC) and postnatal care (PNC) practices by comparing Users and Non-Users of Tiko platform, and accounting for the selection bias statistically. The structured questionnaire collected data on knowledge, practices, barriers, enablers for SRH and MCH services, exposure o Tiko platform, and how it helped or did not help. The survey participants were approx. 1200 users and 600 non-users being served by approx. 350 pro-agents in their respective operations area.

The association between use of Tiko platform and various outcomes were identified using a generalized linear model with fixed effects at pro-agent level and including a set of covariates. To evaluate the effect modification by type of pro agent - government community health worker (CHW) versus others - an interaction model was used. The standard errors were automatically clustered at pro-agent level due to fixed effects. Primary outcomes are proportion of married Rafikis currently using any contraceptives, currently using modern short-term contraceptives, proportion of Rafikis who delivered a child post Jan 2019 and received at least 4 ANC check-ups, consumed at least 100 iron folic acid (IFA( during pregnancy, and received a PNC check-up within 6 weeks of birth.

See subsequent sections

Eligibility Criteria:
Inclusion Criteria:

* Women who are registered on Tiko Platform with Pro-agents active in 2020-21
* Age 18-50
* Address and contacts details are found with help of Pro-agent

Exclusion Criteria:

* Does not consent to participation
* Does not agree or confirm registering on Tiko Platform
* If a woman is never married, she is excluded from survey on family planning but surveyed for use of Tiko platform
* If a married woman does not have a child born on/after 1 January 2019, then she is excluded from the survey on antenatal care, delivery and postnatal care but surveyed for use of Tiko platform
Home Hemodialysis Assisted by a Nurse for Arterio-venous Fistula Cannulation

Home HD (HHD) is associated with better outcome in end-stage renal disease patients compared to in-center HD, in particular in terms of quality of life. However fear of AVF cannulation is a known barrier for patient's choice and adoption of a HHD program. Providing nurse assistance for the cannulation can help developing HHD programs. The aim of this study is to evaluate the feasibility of assisted home hemodialysis, with the intervention of a nurse at home for arterio-venous fistula cannulation.

* Monocentric prospective interventional study.
* Intervention is assisted HHD, defined as: rope-ladder cannulation at the patient's home provided by a trained private nurse at each dialysis session, and connection to the Nxstage System One
* pilot study, with main objective defined as feasibility of the investigator's assisted HHD program. Pilot study usually concerns a small population, allowing us to develop thereafter a bigger study if the results are encouraging.
* primary end-point criteria defined as definitive cessation of HHD with transfer to an other dialysis modality.

Eligibility Criteria:
Inclusion Criteria:

* The patient must be aged more than 18, able to read and write, and have a person with him at home during HD session, according to the french law.

Exclusion criteria:

* medical contra-indication for HHD
Conservative Treatment Versus Elective Repair of Umbilical Hernia in Patients With Ascites and Liver Cirrhosis

The purpose of the present study is to investigate whether or not to perform elective surgical repair of umbilical hernias in patients with liver cirrhosis and ascites. There are no other randomized controlled trials in this area. The optimal management in patients with umbilical hernias and liver cirrhosis with ascites is not clear yet. The general surgical opinion is that umbilical hernias in patients with ascites should not be corrected because of the supposedly high operative risks and high recurrence rates. Conservative treatment, however, can have severe complications resulting in emergency repair. Such operations carry a higher risk of complications than elective operations, particularly in this group of patients. Prospective and retrospective series showed us that elective hernia repair in this specific patient group is safe without major complications or high recurrence rates.

The aim of this study is to asses the optimal timing of correction of umbilical hernia in patients with liver cirrhosis and ascites.


Eligibility Criteria:
Inclusion Criteria:

* Primary Umbilical hernia
* Liver cirrhosis
* Ascites (US proven)
* Age ≥ 18 years
* Signed Informed consent

Exclusion Criteria:

* Recurrent umbilical hernia
* Midline laparotomy in medical history
* ASA1 score IV or above
* Incarcerated hernia related emergency procedures
* Patent umbilical vein; \>5mm
* Expected time to Ltx \<3 months
Drug-drug Interaction Study of Rosuvastatin and AT-527 (R07496998)

Drug-drug interaction study of rosuvastatin and AT-527 (R07496998)


Eligibility Criteria:
Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Females must have a negative pregnancy test at Screening and prior to dosing
* Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m2
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Concomitant use of prescription medications, or systemic over-the-counter medications
* Other clinically significant medical conditions or laboratory abnormalities
Esophageal Cooling for AF Ablation

The purpose of this study is to determine if esophageal cooling using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) limits the number or seriousness of injury to the esophagus during atrial fibrillation ablation procedures. The EnsoETM is an FDA cleared device used for temperature management, but is not routinely used during atrial fibrillation ablation procedures.

The EnsoETM is a non-sterile multi-lumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while simultaneously allowing gastric decompression and drainage. Modulation and control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger. Two lumens connect to the external heat exchanger, while a third central lumen provides stomach access for connection to a fluid collection device with low intermittent suction for gastric decompression. The EnsoETM is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with an intended duration of use of 72 hours or less. Distilled water circulates within the EnsoETM just like a water blanket.

Eligibility Criteria:
Inclusion Criteria:

1. Patients above the age of 18 years old.
2. Patients with the diagnosis of atrial fibrillation undergoing clinically indicated de-novo AF ablation procedure.
3. Patients must be able to understand and critically review the informed consent form.

Exclusion Criteria:

1. Patients whom are unable to provide informed consent.
2. Patients with contraindication to EGD.
3. History of prior AF ablation procedures.
4. Significant co-morbidities that preclude standard ablation procedure.
5. Patient is ineligible for EnsoETM placement due to:

   * Known esophageal deformity or evidence of esophageal trauma (for example history of esophagectomy, previous swallowing disorders, achalasia).
   * Known ingestion of acidic or caustic poisons within the prior 24 hours.
   * Patients with \<40 kg of body mass.
Dexmedetomidine on Brain Injury Patients

The aim of the study is to check whether dexmedetomidine has neuroprotective properties in brain injury patients.

The enrolled 60 patients will be divided into two groups; Group 1(n=30):

are the patients who will receive dexmedetomidine. Group 2 (n=30): are the patients who represent the control group.

1. Approval will be obtained from the Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
2. All participants must agree to take part in this clinical study and provide informed consent.
3. The required sample size will be calculated.
4. 60 Patients with brain injury will be enrolled from the intensive care department, Damanhour medical national institute.
5. Serum samples will be collected for measuring the biomarkers.
6. All enrolled 60 patients will be mentioned as two groups; Group 1(n=30):

   are the patients who will receive dexmedetomidine. Group 2 (n=30): are the patients who represent the control group.
7. All patients will be followed up during their stay in the intensive care department.
8. During their stay in the intensive care department, step 5 will be repeated.
9. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
10. Measuring outcomes: the primary outcome is measuring the neuroprotection provided by dexmedetomidine reflected by change in patients' symptoms, while secondary outcome is the change in the level of biomarkers from baseline to post-treatment.
11. Results, discussion, conclusion, and recommendations will be given.

Eligibility Criteria:
Inclusion Criteria:

* 60 Patients with brain injury with age ranging from 18 to 70 years, there are no limits to gender.

Exclusion Criteria:

* Patients with significant liver impairment
* Patients with known heart failure
* Patients with hypotension
* Patients with bradycardia
Transcutaneous Auricular Vagus Nerve Stimulation for Treating Post-stroke Dysphagia

The aim of the present project is to use transcutaneous auricular vagus nerve stimulation (t-VNS) for the treatment of dysphagia in acute stroke patients to improve swallowing function and reduce mortality and disability related to this condition.

30 patients will be randomized into one of the two arms of the study:

* REAL: real t-VNS + speech therapy
* SHAM: t-VNS placebo + speech therapy. The experimental treatment consists in the association between t-VNS (real or placebo) and speech therapy exercises to improve swallowing functionality. Each patient will undergo a speech therapy rehabilitation session lasting approximately 40 minutes a day for 3 consecutive days, simultaneously with t-VNS on left ear.

Swallowing function and clinical conditions will be evaluated before the intervention (baseline, T0), immediately after the intervention (T1) and 3 months after the intervention (T2).


Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic or hemorrhagic stroke (within 7 days of onset)
* Dysphagia diagnosed by FEES with a Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) score between 3 and 5

Exclusion criteria:

* Pre-existing stroke dysphagia
* Dementia or other medical conditions that may interfere with the study
Smoking Cessation in the Surgical Pathway Before Major Lung Surgery

This is a feasibility study of a personalised, integrated smoking cessation in the surgical pathway in patients undergoing major elective thoracic surgery when compared to usual care of standard community/hospital based NHS smoking cessation. Half the patients will receive the intervention and half the patients will receive usual care.

Smoking prior to major thoracic surgery is a major risk factor for development of postoperative complications which effect both short and long-term outcome. Despite this 1 in 5 patients continue to smoke before their operation.

Project MURRAY is a trial comparing the effectiveness of personalised integrated smoking cessation delivered by trained health-care practitioners in the thoracic surgical pathway, and is a three part package of behaviour interventions and pharmacotherapy as per National Institute of Clinical Excellence (NICE)/ National Centre for Smoking Cessation Training (NCSCT) guidance which is supported by an adjunct web-based application. This is a pilot study to evaluate feasibility of a substantive trial and study processes in 5 adult thoracic centres including the trial coordinating site at the University Hospitals Birmingham NHS Foundation Trust. This is a multicentre feasibility study, with aim for equal weighting between the two arms of the integrated smoking cessation and an observation only group of usual care.

Eligibility Criteria:
Inclusion Criteria:

* Current tobacco smoker (smoked within the last 28 days)
* Major Thoracic Surgery (including both open and minimally invasive approach)
* Able to provide written informed consent
* At least 1 weeks' time to surgery
* Age over 18 years

Exclusion Criteria:

* Emergency thoracic surgery
* Inability to perform exhaled carbon monoxide (CO) measurements
Serum Metal Ion Concentration After Total Knee Arthroplasty (TKA)

All metal implants release metal ions because of corrosion. Total knee arthroplasty implants have large metal surface areas and therefore substantial potential for corrosion. It is planned to compare changes in serum levels of metal ions in patients after implantation of cemented unconstrained total knee arthroplasty covered with or without a passivating surface. Serum concentrations of chromium, cobalt, molybdenum and nickel will be analyzed and compared between the two groups, as well as with those of 130 control patients without implants.


Eligibility Criteria:
Inclusion Criteria:

* Indication for TKA in primary oder secondary osteoarthritis of the knee
* Patient's consent

Exclusion Criteria:

* Additional Implants present
* Allergy against constituents of implant or cement
* Any malignancies
* Renal insufficiency
* Any additional serious disease complicating the participation in this study
R-One Efficiency For PCI Evolution With Robotic Assistance

This study is a Prospective, Multi-center, Single-arm clinical study, in patients with Coronary Artery Disease, including patients with silent ischemia (excluding STEMI), who qualify for elective Percutaneous Coronary Intervention (PCI), aimed to assess the Safety and Efficacy of the R-One device in elective PCI.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* Candidate for PCI;
* Presence of a de novo coronary artery stenosis of ≥ 50% and \<100% in a native coronary artery indicated and suitable for stent implantation;
* The vessel has a reference vessel diameter ranging from 2.5 mm to 4.0 mm;
* The target lesion length allows for treatment with a single stent up to 38 mm in length;
* Up to 2 target vessels each with a single target lesion requiring a single stent per lesion and treatable within a single procedure may be included (no further staged procedure allowed);
* The patient provides written informed consent as approved by the applicable Ethics Committee and is willing to comply with all study requirements including 30 days follow-up.

Exclusion Criteria:

* Target lesion has TIMI flow \< 3;
* Treatment of in-stent restenosis, or prior stent in the target vessel proximal to the target lesion;
* More than one target lesion per vessel requiring treatment at the time of procedure;
* Target lesion is a bifurcation requiring balloon or stent implantation of the side branch, with a side-branch RVD of ≥1.5 mm with a DS ≥50% at or within 5 mm its origin, or RVD ≥2.0 mm regardless of the presence of side branch disease;
* Target lesion is located in left main coronary artery, or any left main stenosis \> 30%;
* Target lesion is within 5 mm of the ostial LAD, ostial LCX or ostial RCA;
* Severe vessel tortuosity;
* Severe vessel calcification;
* STEMI, cardiopulmonary resuscitation or cardiogenic shock within 48 hours of the procedure;
* Presence of visible thrombus;
* Need for any procedure other than balloon angioplasty or stenting (e.g. atherectomy, laser, are excluded);
* Patients under judicial protection, tutorship or curatorship (for France only);
* Any patient participating in another clinical study evaluating a drug or a medical device (except registries for which the primary endpoint has not been evaluated;
* Pregnant and breast-feeding women or intention to become pregnant prior to completion of all follow-up procedures.
Can Vibration Stimulation of the Foot Sole Activate Leg Muscles?

Participants will be asked to complete three different tests (standing, stepping and assisted walking) and will experience three different experimental conditions during each test. The three conditions are types of vibratory plantar cutaneous stimulation, which include no vibratory stimulation, submaximal vibratory stimulation and supramaximal vibratory stimulation. In the first condition, participants will experience no stimulation applied to any part of the body. In the second condition, a submaximal vibratory stimulus will be delivered at 90% of the participant's threshold to the surface of the foot. In the third condition, a supramaximal vibratory stimulus will be delivered at three times the participant's threshold. The hypothesis is that this plantar stimulation (90% threshold and supramaximal) will elicit increased muscle activity during these tests. If the hypothesis is positive then this protocol will also be presented in incomplete spinal cord injuried participants.


Eligibility Criteria:
Inclusion Criteria:

* no spinal cord injury

Exclusion Criteria:

* any musculoskeletal or neurological disease that affects movement or balance