cyrilzakka/clinical-trials huggingface dataset:
Mobile Cognitive Behavior Therapy Targeting Anxiety Disorders

This study aims to examine different ways of motivating people to make use of Maya, a mobile cognitive behavior therapy (CBT) program for adolescents and young adults experiencing anxiety symptoms, and to assess whether social supports are as efficacious, or more efficacious, than other non-monetary incentives. Subjects will use the Maya app for at least 20 minutes per day, 2 days per week, for 6 weeks. Assessments will include a weekly check in with a member of the research team, questionnaires, and an optional magnetic resonance imaging (MRI) recording.

There is a growing need for easily accessed anxiety treatments designed for young adults. Mobile app-based interventions can be disseminated more broadly than traditional psychosocial interventions and may be particularly appealing to this age group, which uses mobile devices frequently. Mobile apps can also collect real-time data about patient symptom severity and provide tailored, in-the-moment coping strategies.

This study aims to examine different ways of motivating people to make use of Maya, a mobile cognitive behavior therapy (CBT) app for adolescents and young adults experiencing anxiety symptoms, and to assess whether social supports are as efficacious, or more efficacious, than other non-monetary incentives. Young adults with anxiety will be randomized to one of three conditions: a social support condition, a gain-framed condition in which participants can earn "points" for completing their assigned sessions, and a loss-framed condition in which participants lose "points" for failing to complete their assigned sessions. Subjects will use the Maya app for at least 20 minutes per day, 2 days per week, for 6 weeks and will complete assessments at baseline, week 3, week 6 (end of treatment), and a follow-up assessment at week 12. Subjects may also choose to complete an optional magnetic resonance imaging (MRI) recording at the baseline and end of treatment (week 6).

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 25
* Primary diagnosis of an anxiety disorder, as determined by a score of 4 on the Clinical Severity Rating from the Anxiety Disorders Interview Schedule (ADIS)

Exclusion Criteria:

* Score of \< 4 on the ADIS
* Primary psychiatric diagnosis other than an anxiety disorder
* Currently in cognitive behavioral therapy outside of the study
* Change in dose of a psychiatric medication in the past 12 weeks
* Intent or plan to attempt suicide
Graded Motor Imagery Training in Shoulder Impingement Syndrome

The aim of this study is to investigate the effects of Graded Motor Imagery (GMI) training on pain, functionality, disability and daily living activities in patients diagnosed with Shoulder Impingement Syndrome.

In this study 42 voluntary patients with Shoulder Impingement Syndrome, aged between 25-65 years will be randomly divided into two groups; group1: "GMI + Conventional Physiotherapy", group 2: "Conventional Physiotherapy".

All participants will receive treatment with a physiotherapist three times a week for six-weeks (18 sessions). At the end of the 6th week, it will be followed regularly with a six-week home exercise program. It will be evaluated by a physiotherapist three times in total (before treatment, at the end of six-weeks of treatment and after six-weeks of follow-up). In addition, all patients will undergo an interim evaluation in terms of primary outcome measures (VAS and DASH score) at week three. The shoulder pain on activity, at rest and at night will be assessed with Visual Analog Scale (VAS), Joint Range of Motion (ROM) will be measured with digital goniometer, strength of shoulder flexor, abductor, external and internal rotator muscles will be assessed with digital dynamometer, functional status will be evaluated with Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, functional status of the hand will be evaluated with Jebsen-Taylor Hand Function Test (JTHFT), lateralization evaluation will be assessed with the Recognise™ application (Shoulder and Hand), and motor imagery will be evaluated with the Kinesthetic and Visual Imagery Questionnair (KVIQ). Patient satisfaction will be evaluated by the Global Rating of Change scale.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 25-65 years old,
* Having been diagnosed with Shoulder Impingement Syndrome by physical examination and MRI as a result of shoulder pain lasting at least 3 months,
* Presence of a painful arc between 60° and 120° in shoulder flexion / abduction (elevation) movements,
* The Standardized Mini Mental Test result must be at least 24 points,
* Not having seen imagery practice before,

Exclusion Criteria:

* Having severe mental and communication problems,
* Having undergone surgical treatment on the same upper extremity,
* Presence of acute trauma, peripheral nervous system lesion, fracture or complete tendon rupture in the affected shoulder,
* Presence of other pathologies such as adhesive capsulitis of the shoulder joint complex and glenohumeral instability,
* Presence of radiotherapy history on the same side as the affected shoulder,
* Presence of congenital deformity,
* Symptomatic cervical spine pathology,
* Presence of other neurological or rheumatological disorders affecting upper motor function,
* Having any chronic disease that would prevent participation in the treatment program,
* Having attended a physiotherapy program within the last month.
Study Evaluating Enbrel in Patients With Rheumatoid Arthritis

The purpose of this study is to investigate the incidence of adverse events for patients with rheumatoid arthritis treated with Enbrel under usual care settings. In addition, differences in injection site reactions based on whether health care professionals or patients administer Enbrel will be assessed and evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Proven diagnosis of rheumatoid arthritis

Exclusion Criteria:

* Contraindications according to Summary of Product Characteristic (SmPC)of Enbrel® the following points will prevent or restrict participation:

  * Patients who suffer from hypersensitivity to the active substance Etanercept or to any of the excipients of Enbrel®
  * Treatment with Enbrel® should not be initiated in patients with active infections including chronic or localized infections
  * Patients with sepsis or risk of sepsis should not be treated
Efficacy of Intravenous (IV) Paracetamol for Treatment of Acute Pain

The purpose of this study is to determine whether Iv paracetamol is as effective as Iv Morphine sulfate on control of the acute pain in Patient with limb trauma.

Limb trauma is a painful condition that requires urgent analgesic treatment . Intravenous Opioids and NSAIDs are used extensively to control pain; both of them are with side effects. Paracetamol is a safe and effective analgesic that is used by oral or rectal routs for pain control, and in therapeutic doses has less side effects than Morphine and NSAIDs, and approved as a safe and effective analgesic in emergency department.

recently Iv Paracetamol has become available in European countries and also in Iran.

efficacy and safety of IV Paracetamol has been studied in post operation conditions and asserted but in emergency setting it has been studied only in renal colic situation.

Therefore, the investigators want to study the efficacy of IV Paracetamol in limb trauma and compare it with Iv Morphine sulfate.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute limb trauma
* Age\>=18 years
* Acute pain of score 3 or greater on visual analogue scale

Exclusion Criteria:

* Unstable hemodynamic (Systolic blood pressure under 90 mmHg)
* Known sensitivity to opioids or paracetamol
* Any other known contraindication to Morphine Sulfate or Iv Paracetamol (including severe allergy to these drugs, acute bronchial asthma, upper respiratory tract obstruction)
* Previous administration of analgesic during 6 hours ago
* Pregnant women
* previous inclusion to the study
* diagnosed heart failure
* renal failure
* pulmonary failure or hepatic failure
Treatment Study of Carnosine Versus Placebo in Gulf War Illness (GWI)

The purpose of this study is to perform a randomized double-blind, placebo-controlled, 12 week study of the effects of carnosine on cognitive, psychometric, autonomic, and muscle strength outcomes in 100 GWI subjects.

Background: Homocarnosine (beta-alanine - gamma-aminobutyric acid) is one of the most abundant dipeptides in the brain. It has important antioxidant properties. Both beta-alanine and GABA are neurotransmitters, suggesting that cleavage of this dipeptide by carnosine dipeptidase 1 (CNDP1) may have important regulatory functions in vivo.

Drug: Homocarnosine is not available. Carnosine (beta-alanine - histidine) is an over-the-counter dietary supplement that shares the antioxidant properties. We proposed that oral carnosine would be absorbed from the gut, cross the blood brain barrier, reduce presumed brain oxidant stress that participated in illness pathology, and improve subject health.

Hypothesis: Carnosine supplementation for 12 weeks by mouth in Gulf War Illness subjects would improve cognitive and other outcomes compared to placebo treatment.

Subjects: Gulf War Illness subjects met 1996 Fukuda criteria for Chronic Multisymptom Illness.

Design: Pilot study. Double blind randomized placebo controlled with comparisons between Week 0 (Baseline, pre-randomization) and Week 12 (end of study) Outcomes: This pilot study included included cognitive testing, magnetic resonance imaging during the 2-back working memory task, self-report of psychometric and other subjective symptoms, tenderness testing by dolormetry, and pain threshold to assess reproducibility in the placebo-treated subjects, and potential treatment effects in the active study drug subjects. The study and each of the outcomes at weeks 0 and 12 are described in detail in the final published paper and in its extensive supplementary on-line materials (Baraniuk JN et al. Glob J Health Sci. 2013 5:69-81. PMID:23618477 PMCID:PMC4209301).

An improvement on accuracy on the 2-back working memory task between 0 and 12 weeks was the primary outcome.

Other evaluations were secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of military enlistment between August 1, 1990 and July 31, 1991, and deployment for 30 consecutive days to:

  * Persian Gulf waters and adjacent land areas,
  * Other global locations, or,
  * U.S. only. 1990-1991 enlistment status:
  * Active duty
  * National Guard
  * Reserves

Exclusion Criteria:

* HIV/AIDS
* Pregnant Women
* Active Duty Military Personnel
* Children
* Incarceration
Study of Verapamil in Refractory Epilepsy

Epilepsy is one of the most common chronic neurological diseases, affecting 300,000 Canadians. One in 3 epilepsy patients have refractory seizures meaning that all antiseizure drugs fail to control their seizures. This drug resistance in epilepsy may be related to the over expression of multidrug resistance proteins (MDR). Varapamil inhibits MDR. We propose to add verapamil/placebo to patients' anti epilepsy medication for 3 months. Patients who receive placebo will have verapamil added for 3 months after the completion of the double-blind treatment period. Seizure frequency/severity will be tracked. Blood samples for DNA will be collected. There will be 9 clinic visits over 32 weeks. ECG and echocardiogram will be done at baseline and repeated if necessary

This open label study will consist of three phases: baseline, Double-blind treatment and open-label-treatment. There are 9 visits over 32 weeks. During the baseline period, the number of seizures will be recorded during 2 months while the patient is on a dose of antiseizure drug(s) that was previously established to provide better seizure control. Blood work, including blood for DNA baseline ECG and echocardiogram will be done and may be repeated if necessary. During the 3 months of double-blind treatment phase, verapamil/placebo will be added to the current medications. Visits are every 4 weeks. Vital signs, seizure counts and adverse events will be evaluated. All patients who received placebo will be offered 3 months of open-label treatment with verapamil.

Eligibility Criteria:
Inclusion Criteria:

* 1. patients in whom seizures are not controlled by their antiseizure medication;
* 2. must have at least 2 seizures per month.

Exclusion Criteria:

* Exclusion: patients with cardiovascular problems that could be adversely affected by verapamil
Guiding Sufentanil Administration With Skin Conductance in Mechanically Ventilated Intensive Care Patients

Opioid administration in mechanically ventilated patients in the intensive care unit (ICU) is essential to maintaining patient respiratory and hemodynamic stability. Mechanical ventilation is a persistently nociceptive event that can continuously causes discomfort in the trachealy intubated patient. This can lead to patient-ventilator dyssynchrony, tachycardia, hypertension, and their associated complications. Opioids blunt respiratory drive, which facilitates mechanical ventilation, and decrease the sympathetic response to nociception. However, excessive opiate administration is associated with many adverse events, including respiratory depression, delirium, ileus, nausea, and vomiting. Currently, the standard administration in our institution of sufentanil, a potent opiate, consists of continuous infusions of 0.15µg/kg/h to 0.3µg/kg/h.

Mechanically ventilated patients are unable to speak and are often sedated. This greatly impacts the patient's capacity to communicate pain. The use of a nociceptive monitor may be a possible solution. Skin conductance monitoring (Pain Monitor, Med-Storm, Norway), measures the peaks per second of electrical conduction. This non hemodynamic monitor uses skin conduction as a surrogate to nociception (i.e., the patient's unconscious response to a noxious stimulus). It may consequently guide opioid administration in ICU patients towards and avoid the consequences of excessive or inadequate antinociception.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient admitted to the ICU requiring endotracheal intubation, antinociception, and sedation

Exclusion Criteria:

* Traumatic brain injury
* use of ketamine, dexmedetomidine, or clonidine
* pregnancy
Influence of Somatuline Autogel 120mg on Post-operative Drainage After Total Mesorectum Excision for Rectumcarcinoma

Total mesorectal excision (TME) is a precise dissection of the rectum and all para-rectal lymph nodes within the mesorectal envelope. It is becoming universally recognized and accepted as the standard technique for surgical excision of rectum carcinomas. TME results in lowest rates of local recurrence, especially when combined with pre-operative chemo-radiotherapy.

Especially after pre-operative chemo-radiotherapy, the post-operative drainage may be important. The quick decrease of this drainage will enable the early mobilisation of the patient and may shorten the time of hospitalization. If this decrease in fluid production can be achieved, it will have a positive effect on the Quality of Life of the patient and will ensure health economic savings by reduction of hospitalization time and resources.

Somatostatin analogues have shown to be able to decrease the secretion of numerous types of bodily fluids.

The aim of this study is to investigate if lanreotide Autogel 120mg is capable to reduce the fluid discharge in patients that underwent a TME for rectumcarcinoma.

Lanreotide Autogel 120mg compared to placebo, administered post-surgery on the fluid discharge in the drain of the patient that underwent a total mesorectum excision (TME) for rectal carcinoma. Patient planned to have a TME will be asked to participate in the study. When they have provided written informed consent, they will be randomized 1:1 to receive either placebo or lanreotide autogel 120mg. Drain fluid will be checked for hematocrit daily post-surgery. Once hematocrit levels of the drain fluid are \<10%, study medication or placebo will be administered. After administration the volume of the drain fluid will be measured every 12 hours for at least 5 days. A sample of the drain fluid will be collected every 24 hours for at least 5 days and frozen at -70°C for total protein content, sodium and chloride analysis afterwards. If the patient has a hematocrit \>10% in his drain fluid for a period of 5 days, this patient can not be randomized.


Eligibility Criteria:
Inclusion Criteria:

* male and female patients
* 18-75 years
* written informed consent to participate the study
* scheduled to have a total mesorectal excision (TME) for rectumcarcinoma

Exclusion Criteria:

* patients with a known intolerance for somatostatin analogues, lanreotide or any of it's excipients
* patients younger than 18 years
* patients unable to provide written informed consent
* patients who received somatostatin or any of it's analogues the last 30 days before the start of the study
* Pregnant and breast-feeding women
* Women not using contraception
The South-Norway Atrial Fibrillation Screening Study

Atrial fibrillation (AF) is the most common sustained cardiac rhythm disorder. The most serious common complication of AF is ischemic stroke.The aim of this study is to investigate the yield of AF screening with a continuous ECG monitor (ECG247) and to estimate the prevalence of silent AF

Atrial fibrillation (AF) is the most common sustained cardiac rhythm disorder. The most serious common complication of AF is ischemic stroke. Many AF cases are undiagnosed due to the asymptomatic and intermittent nature of AF (silent AF). Today there is no simple and inexpensive method of detecting silent AF and thus preventing stroke. The ECG247 Sensor is a new Norwegian digital clinical tool for out-of-hospital self-testing of AF. The innovation project has originated from the University of Agder and Sorlandet Hospital. The COVID19 pandemic is realizing more than ever the need for single-use self-testing out-of-hospital diagnostic tools.

The general aim of this open non-randomized study is to investigate the yield of AF screening with a continuous ECG monitor (ECG247) and to estimate the prevalence of silent AF in a cohort of 1500 65-year-old individuals with additional risk factors for stroke.

If the study results indicate that easy-to-use continuous AF-screening-devices designed for self-testing can identify people with previously unrecognized AF, this study may contribute to change the approach to screening for AF in the community. Consequently, the study may prevent stroke in the future. By preventing stroke, major personal and socio-economic consequences can be avoided.

Eligibility Criteria:
Inclusion Criteria:

* Age \>65 years
* Diabetes, heart failure, hypertension, previous stroke/TIA or other cardiovascular disease (minimum 1 risk factor)
* Informed written consent for participation

Exclusion Criteria:

* Chronic AF
* Lack of ability to cooperate
Patients with Coronary Artery Disease or At High Cardiovascular Risk: Measuring Compliance with Treatment for Obstructive Sleep Apnea Syndrome

Obstructive sleep apnea (OSA) is a sleep disorder characterised by partial or total obstruction of the oro-pharyngeal carrefour during sleep. It is found in between 4% and 25% of the general population and in 40 to 80% of patients with cardiovascular diseases.

Continuous positive airway pressure (CPAP) is the standard treatment for OSA and its efficacy has already been demonstrated in this particular population. However, this treatment is not always accepted or sufficiently tolerated. The mandibular advancement device (MAD) is therefore an alternative treatment for OSA, validated by the French National Authority for Health and particularly relevant in this population because it is generally better tolerated. The aim of our study was to assess compliance, tolerance and usability of CPAP and MAD in patients with coronary artery disease and moderate (Apnea-Hypopnea Index AHI 15-30) to severe (AHI\>30) OSA.


Eligibility Criteria:
Inclusion Criteria:

Target population: with coronary artery disease or at very high risk of coronary artery disease:

* Patients with coronary artery disease with or without co-morbidities (smoking, diabetes, hypertension, dyslipidaemia, renal insufficiency, overweight, emerging factors including anxiety-depression, shift workers, etc.).
* Hypertensive patients at high cardiovascular risk (target organ damage such as LVH or albuminuria)
* Diabetic patients at high cardiovascular risk
* Type of heart disease: ischaemic heart disease without clinically significant heart failure (NYHA II, III, IV) For the experimental group (MAD): patients with moderate or severe OSA with intolerance or refusal of CPAP and managed by MAD.

For the control group (CPAP): patients with moderate or severe OSA treated with CPAP.

Exclusion Criteria:

* Patients with heart failure not stabilised according to the investigator (NYHA IV)
* Severe psychiatric disorders
* Pregnant or breast-feeding women
* Opposition to participation after a period of reflection
* Not affiliated to a social security scheme,
* Persons under court protection,
* Persons under guardianship or curatorship
* Person taking part in another study with an exclusion period still in progress
* Inability to follow the patient during the study period.
Study to Investigate Single Ascending Oral Doses of AZD5213 in Healthy Male and Non Fertile Female Subjects

1. The main purpose of this study is to assess the safety and tolerability of AZD5213 after single oral doses.
2. Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how the study drug enters and leaves your body and how your body acts on the study drug) of AZD5213 in your blood and urine.

One group of subjects will be studied to see how food affects the pharmacokinetics (PK) of AZD5213 in the blood and urine. They will receive AZD5213 once after fasting overnight and then return to the clinic to receive AZD5213 after eating a high fat breakfast.


Eligibility Criteria:
Inclusion Criteria:

* Suitable veins for cannulation or repeated venipuncture.
* Male healthy volunteers should be willing to use barrier contraception during sexual intercourse, ie condoms, even if partner is using contraceptive method, from the first day of dosing until 3 months after the last dosing with AZD5213.
* Body weight of ≥50 to ≤100 Kg and Body Mass Index (BMI) ≥18 to ≤30 kg/m2.

Exclusion Criteria:

* History and presence of any clinically significant disease or disorder such as cardiovascular, pulmonary, renal, hepatic, neurological, gastorintestinal and psychiatric/mental disorders.
* History or presence of gastrointestinal (including irritable bowel disease), hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. Surgery on gastrointestinal tract.
* History of previous or ongoing psychiatric disorders.
Long-term Follow-up of Sanfilippo Type A Patients Treated by Intracerebral SAF-301 Gene Therapy

P2-SAF-301 is an open-label interventional study without administration of investigational product, evaluating the long-term safety and tolerability of intracerebral SAF-301 previously administered to 4 patients with Sanfilippo type A syndrome.

The primary objective is to collect additional safety and tolerability data on intracerebral SAF-301 previously administered to 4 patients with Sanfilippo type A syndrome.

The secondary objective is to further collect data to assess the effects of SAF-301 on neurological and psychological status, and potential biological markers.


Eligibility Criteria:
Inclusion Criteria:

* Patients having completed the previous phase I/II study (P1-SAF-301),
* Family understanding the follow-up procedures and the informed consent,
* Patient's parents having signed the informed consent form.

Exclusion Criteria:

* Participation in any other clinical trial.