cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of SMS in Diabetes Control

Introduction: The Spanish Society of Family and Community Medicine, started the Program of Preventive Activities and Health Promotion, which generates periodic recommendations of preventive methods based on scientific evidence. In the last update it has become evident the need of modifications to adapt the program to modern times and focuses on improving accessibility and offering more flexible responses to users of the program. In this sense, the mobile phone technology could be useful, specifically the messaging service to remind patients their appointments and increase attendance rates. Main objective Compare the percentage of patients in the intervention group compared with the control group who achieved a figure of HbA1c \<7% in 2013.Design: single blind Randomized Clinical Trial. Study population: Patients with diabetes with or without hypertension or lipid metabolism disorder, over 18 years, belonging to the Public Health System of Basque Country (primary care) meeting the inclusion / exclusion criteria. Sample size: 238 patients (119 per arm) to detect a difference of 16% in the percentage of patients with HbA1c lower than 7% between groups: Short Messages Standard (SMS) group: Mobile messages reminding the next review of Papps. Control group: Routine clinical practice. Statistical analysis: The relationship between the intervention received and the main variable (compliance with preventive activities at 12 months) were analyzed using a logistic regression model.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients with or without hypertension or lipid metabolism disorder,
* Aged between 35 and 74 years old with or without hypertension or lipid metabolism disorder,
* Mobile phone holder,
* Able to read messages via mobile phone.

Exclusion criteria:

* Pregnant women,
* Patients whose next date for HbA1c control is less than 2 months
* Patients with HbA1c \<7%
Cystic Fibrosis (CF) Leukocyte Genes as Biomarkers for Novel Therapies

Presently, effectiveness of treatments for CF lung disease is judged by improvement in lung function (FEV1). However, in CF patients, FEV1 can range from severely decreased to normal, and improvements may occur slowly. Thus, clinical trials require many patients over prolonged periods to evaluate medications. As the pace of drug development accelerates, it is no longer possible to test all of the promising candidate therapies using conventional study designs. A sensitive technique for assessing lung inflammation has been developed which uses the expression of genes located in circulating blood cells. Mononuclear cells pass repeatedly through the blood vessels of the lung, and are exposed to many of the inflammatory products that are present in the airways. Over the past 4 years the investigators have identified a small group of candidate genes that are unregulated or downregulated in response to antibiotic treatment. The investigators now propose to prospectively test this method of quantifying lung inflammation in a large group of CF patients undergoing treatment of pulmonary exacerbations. Blood will be sampled before and after antibiotic treatment for a pulmonary exacerbation, and the relative change in gene expression will be compared to improvement in FEV1 and other clinical responses, to determine the utility of this method for use in studies. If successful, this technique could allow for a rapid and noninvasive method to gauge immediate effects by new treatments, and assist caregivers in determining optimal treatment strategies for the individual.


Eligibility Criteria:
Inclusion Criteria:

1. Documented diagnosis of CF.
2. Age 18 years old or greater.
3. Presentation at the start of treatment for a pulmonary exacerbation of CF.
4. Ability to perform reproducible Pulmonary Function Tests.
5. Willingness to comply with study procedure and willingness to provide written consent.

Exclusion Criteria:

1. Participation in an investigational drug study within one month of enrollment.
2. Presence of a condition or abnormality that, in the opinion of the Principal Investigator (PI), would compromise the safety of the patient or the quality of the data.
Pilot Study of the Genius(TM)2 Tympanic Thermometer in Cardiac Patients Requiring Cardiopulmonary Bypass

Primary study objective is to test the accuracy of the Genius 2 tympanic thermometer and the Exergen TAT-5000(TM) temporal artery thermometer as compared with serial perioperative core temperature measurements obtained in cardiac surgical patients during cardiopulmonary bypass. Study hypothesis: The Genius 2 thermometer will display greater precision and accuracy than the Exergen TAT-5000 thermometer when compared to core body temperature in patients undergoing CABG surgery.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adult subjects greater than/equal to 18 years of age providing signed informed consent
* Febrile or afebrile
* Planned monitoring of core temperature at a minimum of two separate sites, one of which includes the pulmonary artery
* Planned use of cardiopulmonary bypass for a cardiac surgical procedure.

Exclusion Criteria:

* Mist tents or oxygen hoods
* Hot or cold applications to the head
* Patients that have the planned use of deep hypothermic circulatory arrest
* Aural anomalies (e.g., external auditory canal less than 2cm in length, persistent ear pain)
* Any other major anomaly, surgery or medical condition precluding participation according to manufacturers' stated exclusions or in the opinion of the principal investigator
* Blood, cerumen, excessive hair, inflammation, infection, ulceration or foreign object in the ear observed by otoscopic examination
* Any other signs or symptoms of distress or a condition which would, or in the opinion of the principal investigator, render their participation in the study detrimental to their well-being.
* Previous refusal or enrollment in this study
* Previous or concurrent participation in a clinical trial of a drug or device within the past 30 days.
Thoracic Manipulation Versus Myofascial Release in Patients With Shoulder Impingement Syndrome

aims: • To investigate the effect of adding thoracic manipulation vs myofascial release to scapular stabilization exercise on pain intensity.

* To investigate the effect of adding thoracic manipulation vs myofascial release to scapular stabilization exercise on pain pressure threshold.
* To investigate the effect of adding thoracic manipulation vs myofascial release to scapular stabilization exercise on shoulder proprioception.
* To investigate the effect of adding thoracic manipulation vs myofascial release to scapular stabilization exercise on shoulder range of motion(ROM).
* To investigate the effect of adding thoracic manipulation vs myofascial release to scapular stabilization exercise on disability of shoulder and hand questionnaire(DASH).

Various researches have been done on rehabilitation of shoulder impingement by addressing either osseous structure or myofascial structure and found to be effective. But no studies could retrieve to compare these two: myofascial release and thoracic manipulation. (Dash \& Deepak, 2020). so in this study we will investigate the effect of adding thoracic manipulation versus myofascial release in patients with shoulder impingement syndrome. we will investigate the effect on each of the following: pain intensity will measure by visual analogue scale.(VAS).

proprioception of the shoulder by isokinetic dynamometer. pain pressure threshold by algometer. function by DASH questionnaire and finally ROM by kinovea software.

The subjects will be arranged into three groups: Group I (control group) will receive scapular stabilization exercises.

* Group II will receive scapular stabilization exercises and thoracic manipulation combined with shoulder mobilization.
* Group III will receive scapular stabilization exercises and myofascial release by instrument assisted soft tissue mobilization techniques(IASTM).

the measurements will take before and after treatment programs and after one month of follow up.

Eligibility Criteria:
Inclusion Criteria:

1. Sixty patients with shoulder impingement syndrome from both genders their age will be ranged and divided into three groups from 25-40 years.
2. History of shoulder pain for at least one month.
3. Positive Neer's impingement test and Hawkins's kiennedy test.
4. Presence of thoracic hypomobility from clinical evaluation.
5. Provocation of pain above 60 degrees of flexion and abduction.
6. Palpable trigger points on shoulder muscles.

Exclusion Criteria:

1. History of Shoulder girdle fracture, dislocation and surgery
2. Diagnosed with frozen shoulder or rotator cuff tear
3. History of cervicobrachial pain
4. Any neuromuscular pain in upper limb and use of corticosteroids or pain subsiding medication
French National Registry of Adults With Growth Hormone Deficiency Treated With Somatropin

This study is conducted in Europe. The aim of this study is to extract data from the French National Registry holding information about patients having initiated growth hormone therapy with the objective to describe patients receiving growth hormone therapy, assess efficacy and safety of somatropin (Norditropin® SimpleXx®) and evaluate treatment compliance.


Eligibility Criteria:
Inclusion Criteria:

* Adult with growth hormone deficiency
* Treated with Norditropin® SimpleXx (somatropin)
Effect of Hp Infection on the Quality of Gastric Mucosa Preparation

The purpose of this study was to evaluate the effect of Helicobacter pylori infection on the quality of gastric mucosa preparation.

The purpose of this study was to evaluate the effect of Helicobacter pylori infection on the quality of gastric mucosa preparation by comparing the cleanliness of gastric mucosa between patients with Helicobacter pylori infection and those without Helicobacter pylori infection.

Eligibility Criteria:
Inclusion Criteria:

* Adults who volunteered to participate in this study and signed an informed consent form
* Have been tested for Helicobacter pylori and have definite test results

Exclusion Criteria:

* Contraindications for gastroscopy (such as severe cardiopulmonary diseases, liver and kidney dysfunction, shock, etc.)
* History of upper gastrointestinal surgery
* Therapeutic endoscopy and emergency surgery are required
* Recent history of upper gastrointestinal bleeding
* Corrosive substance ingestion
* The pregnancy
* Abnormal mental state cannot cooperate with the examination
* Patients with contraindications to the drugs used in the study.
Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study

This trial will test, in a representative group of IBD patients, the acceptability of - and adherence to - the IBDoc test (a new home test for faecal calprotectin in the monitoring of inflammatory bowel disease (IBD)).

Crohn's disease (CD) and ulcerative colitis (UC) are forms of inflammatory bowel disease (IBD) that require long-term monitoring. People with these conditions require regular and repeat testing, sometimes with endoscopy, to assess the state of the disease. Many centres worldwide now use a stool test called faecal calprotectin (FCALP) as an accurate reflection of endoscopic disease activity - meaning that people with IBD do not need 'routine' endoscopy to assess their disease. FCALP can also be used to give a prediction of what will happen to a person's IBD in the near future.

As such, FCALP is an excellent and highly cost-effective test in IBD. However, uptake is often low (as with all stool tests) particularly because the sample needs to be taken at home and delivered in to the laboratory or hospital to be tested. People still therefore need to make an effort to submit samples and find this inconvenient. Furthermore, treatments for IBD are increasingly being given at home (usually self-administered injections). While beneficial for people with IBD, it is more difficult to keep track of such patients in the hospital service as they attend less regularly. A test that can be done at home, while making results available to the hospital team, is therefore desirable.

New technology allows reliable testing of FCALP at home, using a smartphone app (IBDoc-TM, Buhlmann Laboratories) within a few minutes. The test kit is packaged with everything required (including gloves, sample 'capture' paper, disposal bag, etc). An instructional video is available within the app itself.

Apart from testing whether patients adhere to the testing schedule, the investigators will also compare their experiences of the IBDoc test, health anxieties, locus of control, and satisfaction vs postal and traditional 'drop-off' test. Validated questionnaires will include: GAD7, PHQ9, IBDC, CBRQ and MHLC as well as a proprietary satisfaction questionnaire at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with inflammatory bowel disease diagnosed at least 6 months prior to study entry
* Willing to participate in home testing and have smartphone
* Able to understand English or explanation via interpreter, and provide written consent

Exclusion Criteria:

* Participants without smartphone (Android or iOS)
* Unable to understand English (excl. via interpreter)
* No previous experience of submitting stool samples for faecal calprotectin measurement
Effectiveness of Acupuncture Treatment Applied in Addition to the Rehabilitation Program in Multiple Sclerosis Patients

The purpose of the study is to assess the effect of acupuncture treatment combinated with conventional rehabilitation methods on gait, fatigue, quality of life and bladder functions in patients with multiple sclerosis

After being informed about study and potential risks, all patient giving written informed consent will undergo screening period determine eligibility for study entry. The patients who meet the eligibility recruitments will get treatment into two groups in a conventional rehabilitation and acupuncture combined with conventional rehabilitation

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with MS according to McDonald criteria
* EDSS score between 1-6
* The patient is clinically stable
* Having not had a new MS attack in the last 3 months
* Being cognitively suitable to participate in the study

Exclusion Criteria:

* Being clinically unstable
* Inability to cognitively participate in tests
* Having received acupuncture treatment in the last 6 months
Whole Exome Sequencing in Prenatal Diagnosis of Agenesis of the Corpus Callosum

Agenesis of the corpus callosum (ACC) is one of the most frequent cerebral malformations and is now diagnosed prenatally in most cases. Prenatal counseling is then challenging because of uncertain neurodevelopmental outcome, depending on the genetic cause of ACC. Our purpose is to evaluate the feasibility of sequencing known genes responsible for ACC by whole exome sequencing (WES) in trio (fetus and both parents) when ACC is diagnosed during the pregnancy, in order to provide complete and loyal information on the intellectual prognosis for the fetus.

Agenesis of the corpus callosum (ACC) is one of the most frequent cerebral malformations. The neurodevelopmental outcome of patients with ACC is extremely variable, ranging from normal intelligence to severe intellectual disability (ID). When ACC is discovered during the prenatal period, prenatal counseling is challenging because of this uncertain neurodevelopmental outcome. Currently, only chromosomal analyses are performed in cases of prenatal diagnoses, which are expected to bring the diagnosis in only few cases. No molecular studies of genes implied in ACC with or without ID are performed. Then, the couples are in the difficult situation of continuing or interrupting the pregnancy without complete information about the aetiology of ACC.

All patients will have a consultation with an obstetrician and consultations with a paediatric neurologist and a geneticist. The geneticist will explain WES and its issues. Both parents will have to provide informed consent for the study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* ACC diagnosed prenatally during the 2nd trimester of pregnancy, confirmed by ultrasound by a referee
* Fetal sample (amniotic fluid, 10 ml) et blood samples of both parents (2 tubes of 5 ml EDTA)
* Covered by social security
* Written consent obtain for routine and research genetic analysis

Exclusion Criteria:

* Refusal to participate from one or both parents
* Pregnancies obtained with gamete donation (trio sequencing not feasible)
* If one parent is not available (trio sequencing not feasible)
* Inability to understand the given information
* One or both parents under juridical protection
Life Quality of Children in Cancer Remission During School Reintegration

Few data about the evaluation of consequences of past life with cancer on life quality of children in school reintegration are available in literature. Nevertheless, some of these studies show that the reintegration impairs life quality of these children (school difficulties, conflictual relations with peers...). The hypothesis is that children with past life with cancer have more chances to have school integration difficulties with a consequent life quality degradation compared to healthy children.

The main objective of this project is to study the relation between the satisfaction of school reintegration of children in cancer remission and the evolution of life quality in the medium term (after getting back to school). More exactly, it is the question if the satisfaction of school reintegration influences life goals and priorities of these children.

The secondary objective is to study the role of psychological status of these children (anxiety, depressive symptoms) on satisfaction-life quality relation.

A group of children with cancer history sent to ordinary school is compared to a control group of children sent to school in the same conditions (sex and age matched). Data are collected with questionnaires some months to several years after school reintegration and same questionnaires 1 year later.

If the study hypothesis is confirmed, this study will show the necessity of a long term follow up of children in cancer remission and not only medical care, but also psychological and social care, in order to support a better school reintegration.


Eligibility Criteria:
Group of children in cancer remission:

Inclusion Criteria:

* Children of both sexes in cancer remission (leukemia, with or without transplant and solid tumors), aged 8 to 12
* Stop of treatment since at least 6 months
* Back to school since some months to several years
* Signed consent of parents

Exclusion Criteria:

* Psychic difficulties
* Specialized education

Group of control children:

Inclusion Criteria:

- Signed consent of parents
Does the Message Matter? Enhancing Adherence in Healthcare Through Persuasive Messages

In this research we propose to develop a comprehensive model to explain how users process persuasive messages. We then propose to experimentally test varying the persuasiveness of message content in various domains, and assess their impact on adherence by both physicians and patients. Finally based on our conceptual model and results from the experimental data we propose to develop preliminary guidelines to assist developers in designing effective messages.


Eligibility Criteria:
Inclusion Criteria:

Study 1

1. Subjects who have an appointment scheduled at HCHD Baytown Health Center

Study 2

1. Subjects who are neonatology physicians (not in training).
2. Subjects must be able to give signed informed consent.

Study 3

1. Any subjects (students or employee) at the University of Texas Health Science Center at Houston.
2. Subjects must be able to give signed informed consent.

Exclusion Criteria:

* No specific individual who meets the inclusion criteria will be excluded.
Athrectomy and Drug Eluting Balloon Therapy (ADEBT) on the Femoral Popliteal Arteries

The aim of this study is to study the effects of athrectomy followed by percutaneous transluminal angioplasty using Paclitaxel coated Drug Eluting Balloon (DEB) in treating de novo or re-stenotic lesions in the femoral-popliteal artery in patients with symptomatic peripheral vascular disease in an Asian population. The intention is to study the effects of debulking athrectomy followed by application of DEBs to prevent restenosis, resulting in improved patency rates The study will prospectively recruit 8 cases treated with athrectomy followed by DEB. This project is a pilot to investigate the effects of athrectomy and DEB in reducing re-stenosis rates. It will be a primer for a larger scale randomized controlled trial (RCT) involving multiple institutions to demonstrate the benefit of athrectomy and DEB technology to treat de novo versus plain balloon angioplasty with bail-out stenting, which is currently the most commonly used modality to treat femoral-popliteal lesions. There are no studies combining the effect of rotational athrectomy and DEBs.

Patient will undergo an intervention under anaesthesia. After common femoral artery sheath access, a diagnostic angiogram will be performed. After pre-arthrectomy Intravascular ultrasound (IVUS) of the affected arterial segment, patient will undergo treatment of the lesion with arthrectomy, followed by post-arthrectomy IVUS analysis. Following arthrectomy, the affected vessel will be treated by supplementary Ranger Drug Eluting Balloon (DEB). During post-procedure, patients will be started on dual antiplatelets for 3 months followed by Aspirin for life unless contraindicated. Clinical follow-up, duplex ultrasound (to assess for re-stenosis) and Ankle Brachial Pressure Index (ABPI) will be performed at 1-month, 6-month and 12-month post intervention. Assessment of the symptoms, pulse, and clinical patency will be performed at each visit.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic ≥ 50% stenosis or occlusions of the femoral or popliteal artery (including below knee popliteal artery) proven on 2 views during angiography of Rutherford stage 2-6 lesions
* At least one tibial vessel runoff
* Life expectancy \>1 year

Exclusion Criteria:

* Subintimal recanalisation of the affected de novo artery which would preclude treatment with athrectomy
* Patient unwilling or unlikely to comply with follow-up schedule
* GFR \<30 ml/min
* Planned major index limb amputation
* Acute limb ischaemia
* Untreated ipsilateral iliac artery stenosis ≥ 50
* Previous atherectomy, brachytherapy or cryoplasty of the affected arterial segment
* Severe flow limiting dissection or residual stenosis \>50% post initial athrectomy requiring supplementary stenting
* Female patients of childbearing potential