cyrilzakka/clinical-trials huggingface dataset:
AlcoChange: An Open Label Pilot Study of Smartphone Monitoring for Alcoholic Liver Disease

Alcohol contributes to over 5% of deaths worldwide, and death rates from alcohol-related liver disease (ARLD) in the UK continue to rise sharply. On-going alcohol use in ARLD leads to markedly increased mortality (Thursz et al, 2015), and maintaining abstinence is a key therapeutic goal. However, there are no effective pharmacological therapies for maintaining abstinence. Brief intervention (BI) is an effective psychological tool for reducing alcohol use, but is difficult to scale widely.

AlcoChange is a smartphone app and breathalyser (AlcoChange), which facilitates self-monitoring and delivers BIs in response to patient triggers. The aim of this open-label study is provide AlcoChange to 60 patients with ARLD, to determine compliance with the app/breathalyser and changes in self-reported alcohol consumption.

Recruitment of inpatients/outpatients with ARLD and recent alcohol use will take place at Royal Free London. The inclusion criteria are: intent to maintain abstinence, possession of compatible smartphone. The exclusion criteria are: inability to provide consent. Participants will be assessed at baseline and 3-months. The primary endpoint is self-reported alcohol use (units/week, timeline follow-back). Secondary endpoint is compliance with the app (monitored remotely).


Eligibility Criteria:
Inclusion Criteria:

* presence of ARLD
* age 18-70
* intent to maintain abstinence
* possession of compatible smartphone

Exclusion Criteria:

- inability to provide consent.
Effectiveness of an Aerobic Exercise Program in Cancer Survivors.

A prospective study of cancer survivor patients enrolling in a pilot aerobic exercise program. The total enrollment will be fifteen patients. The study timeline includes a screening period of 4 weeks, baseline period of 2 weeks, and active study intervention for 12 weeks. Study enrollment will continue until all 15 subjects are enrolled or up to 12 months, whichever comes first.

Study Population: Adult cancer survivors within one year of completing cancer-directed therapy.

Study Objective: To determine the feasibility of a prescription exercise program in a cancer survivor population

Specific Objectives:

1. Quantify the number of patients who successfully enroll and complete the Program.
2. Determine a preliminary benefit, if any, of the program with regard to biometric parameters (change in systolic blood pressure, BMI, body composition, average step count, VO2 max), laboratory parameters (Hgb A1c, CRP, Lipid Profile, IL-6, Apolipoprotein B, Vitamin D-25-OH, Vitamin B12 and Folate), patient-reported wellness surveys (SEE, SRQ, Sleep Surveys).

Study Endpoints/Outcomes:

A. Percentage of participants who complete the Program. B. Change in systolic blood pressure C. Change in BMI D. Change in body composition E. Change in Average daily step count F. Change in predicted VO2 max F. Change in participant-reported wellness surveys (SEE, SRQ, and Sleep Surveys) G. Change in Circumference measurements (hip, waist, and neck) H. Improvement in laboratory parameters (Hgb A1c, CRP, Lipid profile, IL-6, Alipoprotein B, Vitamin D-25-OH, Vitamin B12, Folate) I. Cancer recurrence

Sample Size: Fifteen subjects

Eligibility Criteria:
Inclusion Criteria:

* Adult (\&gt;18 yr.) cancer survivor patients who completed treatment within the past year and are able to physically participate in the interventional aerobic exercise program.

Exclusion Criteria:

* Non-ambulatory individuals
* Inability to communicate in English
* Lack of transportation to/from appointments (Of note, language and transportation exclusion criteria are based on practical needs for this pilot study. If effective, services would be open to a broader array of patients).
* On medications (e.g., Ozempic, Tirzepatide) which induce prolonged weight loss.
* Patients who received cancer-directed therapy within the past month.
Comparison of Non-Invasive Blood Pressure (NIBP) Using the Biobeat Device with an Invasive Arterial Line Catheter

In this clinical study the investigators will compare blood pressure measurements obtained using the non-invasive, wireless Biobeat monitoring device (both a wrist watch and a patch configuration) to an invasive arterial line catheter (radial or femoral) and a Swan Ganz Catheter in 20 patients immediately after cardiac surgery, at the cardiac intensive care unit.

The Biobeat non-invasive, wireless monitoring device is based on reflective photoplethysmograph (PPG) technology. It measures several vital signs, including blood pressure, stroke volume, pulse rate, pulse pressure, heart rate variability, respiratory rate, saturation, cardiac output, cardiac index, and more. The data is transmitted to Biobeat's application (in both Apple and Google Play), and is available on the individual's cellular phone, tablet, or as a full monitoring system in a hospital department. The aim of this study is to compare the Biobeat monitor with the invasive method of blood pressure measurement, an arterial line, and a Swan Ganz catheter for measurements of cardiac output and stroke volume. The study population includes 20 patients undergoing cardiac surgery. As per local protocol, each one of the participants will come out from the operating room with an arterial line, some will also have a Swan Ganz catheter. Once in the intensive care unit, the investigators will attach the Biobeat non-invasive monitor (both a wristwatch and a patch), these two configurations are identical in terms of the monitoring system), and monitor the participants for 4 hours. Though both methods are continuous, the investigators will record the vital signs every 15 minutes during the 4 hours of the study.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and above patients of both sexes arriving immediately after cardiac surgery to the intensive care unit with a radial/femoral arterial line and or a Swan Ganz catheter and in need for blood pressure monitoring.

Exclusion Criteria:

* Refusal to participate

  * Patients with no need or no technical capability to have an arterial line
  * Pregnant women
  * Individuals under the age of 18 years
  * Patients with lack of judgment/mental illness
  * Patients working in the Sheba Medical Center
Working Memory Training in Young ADHD Children

The purpose of this study is to investigate whether working memory training improves behavioral symptoms, neurocognitive performance, and neural functioning in young children with ADHD.


Eligibility Criteria:
Inclusion Criteria:

* Age between 4 years/6 months and 7 years/4 months
* Diagnosis ADHD, classified by the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 2000)
* A full scale IQ \>= 80
* Psychopharmaca- naïve or -free
* Access to a PC with Windows Vista or Windows XP with internet connection and speakers at home

Exclusion Criteria:

* Currently intensive (i.e. weekly) individual or group psychotherapy
* Regular use of medication
* Diagnosis of one or more of the following comorbid psychiatric disorders: Major depression, Bipolar disorder, Psychotic disorder, Chronically motor tic disorder or Gilles de la Tourette, Conduct disorder, any other autism spectrum disorder except for Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS), Eating disorders, Anxiety disorders
* Neurological disorders (e.g. epilepsy) currently or in the past
* Cardiovascular disease currently or in the past
* Serious motor or perceptual handicap
* Participation in another clinical trial simultaneously
* Educational level and/ or socio-economic situation that makes it unlikely for the family to fulfil this study
Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy

The purpose of this study is to demonstrate non-inferiority of Fully Covered biliary SEMS to Uncovered biliary SEMS in biliary drainage for the pre-operative management of biliary obstructive symptoms caused by pancreatic cancer in patients undergoing neoadjuvant therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Patient indicated for biliary metal stent placement for the treatment of jaundice and/or cholestasis
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study
* Suspicion of pancreatic adenocarcinoma
* Likely indicated for neoadjuvant treatment
* Distal biliary obstruction consistent with pancreatic cancer
* Location of distal biliary obstruction such that it would allow the proximal end of a stent to be positioned at least 2 cm from the hilum
* Endoscopic and surgical treatment to be provided at the same institution

Exclusion Criteria:

* Benign biliary strictures
* Malignancy secondary to Intraductal Papillary Mucinous Neoplasm
* Surgically altered anatomy where ERCP is not possible
* Previous biliary drainage using a SEMS or multiple plastic stents
* Contraindications for endoscopic techniques
* Patients who are currently enrolled in another investigational trial that would directly interfere with the current study
* Pregnancy
Gingival Augmentation Around Implants During Maintenance

This prospective controlled randomized blind clinical study investigated 44 implants displaying lack of KG in 29 subjects. Fourteen subjects received FGGs followed by oral prophylaxis. Fifteen subjects in the control group did not receive FGGs. The width of KG, gingival recession (GR), pocket depths (PD), plaque index (PI) and gingival index (GI) were assessed at baseline, 6, 12, and 18 months. Changes in crestal bone levels, from baseline, were assessed at 18 months.

The purpose of this study was to evaluate clinical and radiographic outcomes following free gingival grafts (FGGs) around implants with limited keratinized gingiva (KG) compared to oral prophylaxis without gingival augmentation.

This prospective controlled randomized blind clinical study investigated 44 implants displaying lack of KG in 29 subjects. Fourteen subjects received FGGs followed by oral prophylaxis. Fifteen subjects in the control group did not receive FGGs. The width of KG, gingival recession (GR), pocket depths (PD), plaque index (PI) and gingival index (GI) were assessed at baseline, 6, 12, and 18 months.

There was a significant gain in KG with a reduction in GR in the FGG group compared to controls at 6, 12, and 18 months. The mean PI and GI were significantly lower for the FGG group at 12 and 18 months.

Eligibility Criteria:
Inclusion Criteria:

1. less than 2 mm KG present on the facial side of implant
2. implant restoration is single unsplinted unit, and has been in function for at least 6 months with an opposing dentition.

Exclusion Criteria:

1. uncontrolled hypertension
2. diabetes mellitus (DM),
3. subjects with a history of a long-term (\>6 months) use of corticosteroid
4. subjects currently taking bisphosphonates, or with a history of taking bisphosphonates regardless of route of administration
5. subjects on medications that cause gingival hyperplasia
6. smokers
7. pregnant women.
REgistRy BRAnch goRE EndopRosthEsis

Multicenter registry on patients treated by the new Gore thoracic branched endoprosthesis

This is a multicenter, non-sponsored, physician-initiated multicenter registry on patients treated with the Gore thoracic branched endoprosthesis.

Inclusion of centers is on a voluntary basis; each participating center includes consecutive patients treated with this device.

Eligibility Criteria:
Inclusion Criteria:

* patients receving the Gore TAG thoracic branched endograft for thoracic aorta pathologies

Exclusion Criteria:

* less than 18 years
* allergy to endograft components
* patients receiving other types of arch endografts
Met Non Small Cell Cancer Registry (MOMENT)

The purpose of this multi-national disease registry is to collect prospectively (with longitudinal follow-up) high-quality, standardized, and contemporaneous data to capture changes in the non-small cell lung cancer (NSCLC) treatment landscape and outcomes over time.

The registry will capture data on participants; demographic, clinical characteristics (including biomarker data), treatment patterns, and effectiveness and safety outcomes for advanced NSCLC with mesenchymal-epithelial transition exon 14 (METex14) participants treated with systemic therapy.

This is a disease registry, which is an organized system using non-interventional methods to collect data on a patient population defined by a particular disease, exposure, or condition, and which is followed over time. Non-interventional means that after participants enrollment, participants will be treated according to the routine clinical treatment decision by the physician. The registry will not impose any treatment or procedure for participants.

Eligibility Criteria:
Inclusion Criteria:

* Participants who signed ICF
* Participants with advanced stage (stages IIIB-IV) NSCLC (all histologies) and Confirmed METex14 skipping alterations (by valid assay)
* Participants who are starting or are already being treated with systemic therapy

Exclusion Criteria:

* Participants who are enrolled in a clinical trial
Effects of Increased Physical Activity Before Thoracoabdominal Esophageal Surgery

Thoracoabdominal oesophageal resection for cancer is a procedure with high risks for complications, and patients' preoperative status is a crucial factor for outcome. There are only a few studies that evaluate the effect of preoperative intervention, including physical exercises and breathing exercises, after this type of surgery.

The aim of the study is therefore to evaluate the effect of a training intervention before resection of the oesophagus.

One hundred patients scheduled for oesophagus resection according to Ivor-Lewis from five different hospitals in Sweden will be included. The patients will be randomized to an intervention group or a control group. The training intervention starts directly after preoperative radiotherapy and chemotherapy are given and lasts until three months postoperatively.

Intervention includes increased physical activity, strength training and respiratory muscle training.

At inclusion and three months after discharge, the patients will undergo tests of physical function and lung function. In addition, they will fill in questionnaires concerning level of physical function, level of physical activity and quality of life. These questionnaires will also be answered one year after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo thoracoabdominal oesophagus resection at one of the five included centra

Exclusion Criteria:

* \< two weeks between inclusion and surgery
* benign reason for surgery
* difficulties in speaking and reading Swedish
* other injury or disease limiting the ability to perform the intervention.
Effect of Dapagliflozin Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion

The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease.

Dapagliflozin is an inhibitor of the sodium-glucose co-transporter SGLT2 in the kidney and is a novel treatment for diabetes type 2. Some studies indicate that SGLT2 inhibitors have benefits on blood pressure, triglycerides levels and help to raise the levels of high density lipoproteins cholesterol (c-HDL).

The aim of this study is to evaluate the effect of dapagliflozin on metabolic syndrome, insulin sensitivity and insulin secretion.

The investigators hypothesis is that the administration of dapagliflozin modifies the metabolic syndrome, insulin sensitivity and insulin secretion.

A randomized, double-blind, placebo-controlled clinical trial its going to carry out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, lipid profile, creatinine and acid uric are going to be load after a 75 g of dextrose load.

12 patients will receive Forxiga (dapagliflozin), 10 mg, one per day before breakfast during 3 months.

The remaining 12 patients will receive placebo at the same dose.

There will be calculated Area Under the Curve of glucose and insulin, total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).

This protocol it's already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers.

Results will be presented as mean and standard deviation. Intra and inter group differences are going to be tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively; p≤0.05 it's going to be considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Patients both sexes
* Age between 30 and 60 years
* Metabolic Syndrome according to the IDF criteria
* Waist circumference
* Man ≥90 cm
* Woman ≥80 cm
* And two of the following criteria
* High density lipoprotein
* Man ≤40 mg/dL
* Woman ≤50 mg/dL
* Fasting glucose ≥100 mg/dL
* Triglycerides ≥150 mg/dL
* Blood pressure ≥130/85 mmHg
* Informed consent signed

Exclusion Criteria:

* Women with confirmed or suspected pregnancy
* Women under lactation and/or puerperium
* Hypersensibility to SGLT2 inhibitors
* Physical impossibility for taking pills
* Known uncontrolled renal, hepatic, heart or thyroid diseased
* Previous treatment for the metabolic syndrome components
* Body Mass Index ≥39.9 kg/m2
* Fasting glucose ≥126 mg/dL
* Triglycerides ≥500 mg/dL
* Total cholesterol ≥240 mg/dL
* Low density lipoprotein (c-LDL) ≥190 mg/dL
* Blood Pressure ≥140/90 mmHg
Work Stress and Impact of Pruritus on Quality of Life

Work stress and pruritus: imbalance of effort balance reward in patients with psoriasis.

Background. Stress increases the likelihood of psoriasis flare-up episodes and itching. Few studies have focused on work-related stress on such skin symptoms.

Objective. To study the association between work-related stress, pruritus and quality of life among workers suffering from psoriasis.

Methods. Investigators will conduct a monocentric non-interventional prospective study. Patients suffering from psoriasis will be recruited in both the Dermatology inpatient ward and outpatient clinic of Brest University Hospital . Included patients will be workers. Work-related stress will be assessed using the Effort-Reward Imbalance (ERI) model. The impact of pruritus on quality of life will be assessed with the Itchy Quality of Life (ItchyQoL) self-administered questionnaire. The collected data will include age, sex, body mass index, ordered medication to treat psoriasis, weekly working hours. The association between ERI and ItchyQoL scores will be studied using a univariate logistic regression.

Eligibility Criteria:
Inclusion Criteria:

* Major patients
* Active busy patients with psoriasis presenting for a dermatology consultation or hospitalization at the Brest CHRU
* Participation agreement

Exclusion Criteria:

* Presence of another potentially pruritic pathology
* No command of the French language
* Patient under legal protection (guardianship, curatorship, etc.)
* Refusal to participate
The Effect of Laser Therapy in the Management of Adhesive Capsulitis: a Randomized Clinical Trial

In this study, it was aimed to compare the effects of low-level laser therapy (LLLT) and high-intensity laser therapy (HILT) on shoulder joint range of motion, level of pain and functional status in patients with adhesive capsulitis

This study will be designed as a randomized, prospective, single-blind clinical trial with a 3-week follow-up. A total of 50 patients who applied to our hospital with the complaint of shoulder pain will be evaluated for inclusion in the study. Patients will be randomized into two groups as high-intensity laser (HILT) + stretching exercise group and low-level laser (LLLT) + stretching exercise group.

Eligibility Criteria:
Inclusion Criteria:

1. patients aged between 25-65 years
2. patients clinically diagnosed with adhesive capsulitis, characterized by limitation of passive external rotation of the affected shoulder to less than 50% of the contralateral shoulder and normal radiographic finding of the affected shoulder
3. patients with severe pain and shoulder limitation for at least 3 months
4. patients who are literate and able to understand verbal instructions in our language.

Exclusion Criteria:

1. Calcific tendinopathy, glenohumeral osteoarthritis, fracture, shoulder surgery, shoulder trauma, history of malignancy and infection, history of inflammatory rheumatic diseases
2. History of bilateral simultaneous adhesive capsulitis
3. Recent history of lung, breast, or bypass surgery/radiotherapy
4. History of corticosteroid injection to the same shoulder in the last 1 year
5. History of cervical radiculopathy/brachial plexus lesion
6. Neuromuscular disease history
7. History of physical therapy program for the same shoulder in the last 6 months.
Prospective Record Of the Use of Dabigatran in Patients With Acute Stroke or TIA

The multi-center, prospective PRODAST study is investigating patients with non-valvular atrial fibrillation (AF) who experienced an ischemic stroke or a transient ischemic attack (TIA) recently (≤ 1 week) both with and without previous oral anticoagulation. It consists of a baseline visit and a 3 months central follow-up for patients who were discharged with dabigatran, vitamin K-antagonists, antiplatelets only, or no oral antithrombotic treatment at all. Thus, data on the use of dabigatran and vitamin K-antagonists in routine clinical practice will be collected to describe how dabigatran is prescribed and used in the population of AF patients with recent cerebrovascular events and how these factors influence important outcome and safety events. The utilization of dabigatran will be assessed with regards to treatment persistence, compliance, proportion of patients discontinuing treatment and reason for discontinuation as well clinical endpoints such as major bleeding, stroke or systemic embolism. Due to the fact that patients will be treated according to local medical practice it is possible that medication will be changed during the observation period. In the follow-up, data from the first as well as from the second prescribed medication will be used in the study. To explore a long-term effect of anticoagulation, survival up to one year will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years at enrollment
* Male or female patient willing and able to provide written informed consent for data transmission. For patients who are not legally competent to sign this informed consent for data transmission exceptions/special cases are described in the protocol.
* Patient with ischemic stroke or TIA within the last 7 days.
* Patient diagnosed with non-valvular AF. Documentation of AF by 12 lead ECG, ECG rhythm strip, monitor print-out, pacemaker/ICD electrocardiogram, Holter ECG (duration of AF episode at least 30 seconds) or written physician´s diagnosis prior to index event needed for all enrolled patients.

Exclusion Criteria:

* Presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention (surgical or non-surgical) during the next 3 months.
* Current participation in any randomized clinical trial of an experimental drug or device.
* Women of childbearing age without anamnestic exclusion of pregnancy or not using an effective contraception or nursing mothers.