cyrilzakka/clinical-trials huggingface dataset:
Effect of Psychoeducation on Motivation to Change in Traumatized Alcoholics

Many people suffering from alcohol dependence have a history of exposure to stressful life situations, such as childhood physical or emotional misuse. Often, there's a functional relationship between drinking and emotional problems related to past traumatic experiences, i.e. drinking to forget. However, alcohol treatment often does not include interventions to support patients to cope better with past life experiences. On the other hand, most alcoholics are poorly motivated to participate in long-term rehabilitative treatments after detoxification. In the proposed study, the investigators will study the effects of a brief psycho-educational group intervention during detoxification treatment on motivation to change and the willingness to accept further treatment.

The investigators will use a group comparison design (intervention versus "TAS" control group). In month 1, patients take part in Treatment as Usual (TAS), including a unspecific information group. In month 2, the information group is replaced by the psychoeducational group (intervention). Ward staff selects patients for the groups, irrespective of intervention or TAS. Selection criteria are: absence of severe withdrawal and cognitive impairment. Absence of severe co-morbid psychiatric disorder (e.g. schizophrenia or suicidal crisis). The group sessions will take place in groups of up to 15 patients and will include 4 structured sessions (45 min each). Main content if the intervention group is to highlight and discuss the association between stress, Posttraumatic Stress Disorder and drinking. Patients will also be informed about the different treatment options available in the region.

At entry, patients are asked to fill in the German versions of the University of Rhode Island Change Assessment (URICA; McConnaughy, Prochaska, \& Velicer, 1983; German: Heidenreich, Hoyer \& Fecht; 2001) and the Trauma History Questionnaire (THQ; Green, 1996; German: Maercker, 2002). At discharge, patients are asked to fill in the URICA.

The investigators expect that specific information on the association between stress and drinking will increase the patients' motivation to participate in further treatment.


Eligibility Criteria:
Inclusion Criteria:

* Alcohol Dependence
* Regular admission to detoxification unit

Exclusion Criteria:

* Severe withdrawal
* Severe cognitive impairment
* Severe comorbid psychiatric conditions (schizophrenia, suicidal crisis)
Simulated Walking With Multiplexing Prism for Field Expansion in Monocular Vision

The investigators are developing an assistive device, known as multiplexing prism that expands the field of view for individuals with acquired monocular vision (loss of an eye). The investigators will test the efficacy of the prism in improving the detection of colliding pedestrians during a simulated walking task.


Eligibility Criteria:
Inclusion Criteria:

* No medical health issues such as seizures, motor movements problem
* Loss of vision in one eye (less than 20/200) for \>1 year
* Visual acuity of the seeing eye: Better than 20/32 visual acuity with correction
* No visual field defect in the seeing eye (nasal field of at least \>45degree)

Exclusion Criteria:

* Patients with any physical or mental disabilities, including cognitive dysfunction, balance problems, or other deficits that could impair their ability to respond to the stimuli presented in this study will be excluded
* Any person with a history (such as pacemaker use or photosensitive epilepsy)
* Any person with motor movements problem (e.g., unable to use extremities)
Collecting and Storing Blood and Tumor Tissue Samples From Patients Undergoing Prostatectomy or Transurethral Resection of the Prostate

The primary objective of this study is to collect material for study's to assess mechanisms of tumor progression, mechanisms of resistance, isolation of stem cells and biologic markers in tissue, serum and peripheral blood mononuclear cells.


Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Undergoing routine prostatectomy or transurethral resection of the prostate (TURP)

PATIENT CHARACTERISTICS:

5.1.1 Patient is undergoing routine prostatectomy or TURP.

5.1.2 Patient is ≥ 18 years old.

5.1.3 Patient must give informed consent.

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Acute Effects of the Prostaglandin (Alprostadil) on Cerebral and Pulmonary Flow

The second stage operation towards single ventricle palliation is 'bidirectional cavopulmonary connection' (BCPC). The superior vena cava is connected to the pulmonary artery, diverting 'blue' blood from the upper body (including the brain) to the lungs. A successful BCPC requires sufficient and easy blood flow through the lungs. Alprostadil is the synthetic form of prostaglandin (hormone that causes dilation of blood vessels) and has been shown to increase blood flow in the brain hence increasing blood flow to the lungs after BCPC, potentially useful in managing children post BCPC with low flow to the lungs and thus poor oxygenation. This study propose to investigate acute effects of Alprostadil on different blood vessels after BCPC.


Eligibility Criteria:
Inclusion Criteria:• BCPC patients at time of routine pre-Fontan assessment: Cardiac catheterization and cardiac magnetic resonance imaging (CMR)

• Patients between the ages of 1 and 6 years old.

Exclusion Criteria:

* Patients who are hypersensitive to this product or to any ingredient in its formulation.
* Patients with seizure disorders or coagulopathies.
* Patients with abnormal kidney function.
A Study of Valsartan Administered Once Daily Versus Twice Daily, in Patients With Stable, Chronic Heart Failure

This study will evaluate the tolerability and safety of valsartan in patients with stable, chronic heart failure (NYHA Class ll-lll). The 12-week double blind study has a 2-week (maximum) screening, and a 10-week active treatment phase. In each of the treatment arms (QD and BID), patients are up-titrated to a maximum valsartan total daily dose of 320 mg. Patients remain on their prior CHF standard care therapy throughout the study period, and the up-titration of valsartan is based on patient tolerability.


Eligibility Criteria:
Inclusion Criteria

* Males or females aged 18 years or older
* Diagnosis of chronic heart failure (CHF), in NYHA Class ll-lll beginning at least 3 months prior to Visit 1
* Patients must remain on their prior standard care CHF therapy

Exclusion Criteria

* Diagnosis of severe hypertension (SBP\>180 and DBP\>110 mm Hg)
* Right heart failure due to pulmonary disease
* Presence of rapidly deteriorating heart failure
* MI or cardiac surgery, including PTCA within 3 months of Visit 1
* Unstable angina or coronary artery disease likely to require CABG or PTCA
* Other protocol-defined exclusion criteria may apply.
A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon Cancer.

This single arm study will evaluate the safety profile of Xeloda as monotherapy for adjuvant treatment of colon cancer. All patients will receive Xeloda 1250mg/m2 p.o. twice daily as intermittent treatment (3 week cycles consisting of 2 weeks of treatment followed by 1 week without treatment). The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* colon cancer (Dukes stage C);
* surgery, with no evidence of remaining tumor;
* ECOG performance status of \<=1.

Exclusion Criteria:

* previous therapy for currently treated colon cancer;
* any evidence of metastatic disease;
* history of other malignancy within last 5 years;
* clinically significant cardiac disease.
Multifaceted Intervention for Increasing Performance of CPR by Laypersons in Out-of-hospital Cardiac Arrest

Cardiac arrest (CA) early recognition is essential in order to rapidly activate emergency services and for bystanders to begin cardiopulmonary resuscitation (CPR).

As soon as a call is received, EMS dispatchers should try to identify CA. This may be difficult, in a context of stress and distress of the person calling. Yet, it is vital for bystanders to initiate CPR. Survival can be multiplied by 2 to 4 if the bystanders initiate a CPR before the arrival of the emergency medical services.

This work aim to assess a multifaceted intervention combining 3 elements to improve the initial phone recognition of CA and raise the number of patients benefiting from CPR before EMS arrival on scene.

The first element is a dispatcher training to the early phone recognition of CA. This training will be based on the concept of active teaching, favouring the interactive work of learners in particular by listening to real dispatch recordings. It will be completed by continuing education with a distance teaching platform including the systematic listening of recorded CA calls.

The second element is based on the deployment of a software aiming to notify CA thanks to mobile phones. This system interfaced to a control software enables to request the participation of CPR-trained volunteers automatically. The volunteers have to be located in the patient's surroundings. The deployment of this mobile application will rely on first-aid volunteers, health personal and any trained volunteers willing to participate. A randomized control study in one city area proved the efficiency of a similar software to improve the proportion of CPR by bystanders.

The third element consists in a motivational feedback. A weekly overview of the management and the outcomes of patients who suffered CA will be broadcast to all the responders and volunteers in the mobile application.


Eligibility Criteria:
Inclusion Criteria:

* All adults with nontraumatic, out-of-hospital cardiac arrest diagnosed during the emergency medical service call
* Cardiac arrest located in urban area

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patients under the law
* Patients deprived of liberty by court ruling or administrative ruling
* Traumatic cardiac arrest
* CA occurring under the eyes of a professional emergency services patrol on duty
* Cardiac arrest for which resuscitation seem unjustified (inevitable death, terminally ill irreversible condition, too long duration of cardiac arrest, non-resuscitation personal directive...)
A Multi-national Study to Identify Treatment Discontinuation Rate in de Novo Alzheimer's Disease Patients Who Have Been Newly Prescribed With Donepezil (Aricept) in Asia (ADOS)

This study is an observational study conducted prospectively under routine clinical setting for 1 year with about 700 patients diagnosed as Alzheimer's disease who will be treated by donepezil (Aricept) as monotherapy. The subjects will be recruited in the selected institutions of about 8 countries in Asia.

Participation in this study places no additional visit schedule, which will be determined by the investigator's judgment based on the disease progression of each subject. Investigators educate subjects to keep decided visit schedule, and collect the required information for case record from (CRF) on the visit.

Eligibility Criteria:
Inclusion Criteria:

1. Greater than or equal to 50 years old and less than 90 years old
2. Diagnosed as probable AD based on NINCDS-ADRDA
3. Patients who have been recently prescribed with donepezil (Aricept) as monotherapy
4. Patients and caregivers who signed the written informed consent from for use of personal and medical information
5. Patients with caregivers who can visit the institution together

Exclusion Criteria:

1) Patients who have taken Memantine or Acetylcholinesterase (AChE) inhibitor prior to participating in the study
Dyslexia, Motor Control and Proprioception

The investigators hypothesize that children with dyslexia present proprioceptive disorders and the purpose of the present study is to better understand relationships between motor control, proprioception and academic learnings. The investigators compare a group of French students with and without dyslexia aged 10-12.

2 groups of children (dyslexics and control) will be evaluated on 2 tasks:

* Evaluation of the proprioception: Perception of the speed and Perception of the position
* Evaluation of the motor learning: Estimation of state in the framework of a motor perturbation

Eligibility Criteria:
Inclusion criteria for all children

* Child with a French social security
* School child
* Native French speaker
* right-handed
* Normal or corrected vision
* Without neurological or psychiatric histories
* Agree to participate in the study in agreement with parental rights representatives

For the dyslexic group :

* pluridisciplinary diagnostic
* never consulted for proprioception before
* without any other leaning disorders like dysphasia
* attention deficit hyperactivity disorder (ADHD) or developmental coordination disorder (DCD)

For the control group :

* regular school attendance
* never consulted for learning disabilities
* No learning disorders known for their parents or siblings.

Exclusion criteria for all children

* genetic disorder
* neurological or psychiatric history
* Delayed psychomotor development
* Reeducation or current treatment interfering with the evaluation
Achieving Energy Balance in Post Partum Teens

This proposal will test Balance Adolescent Lifestyle Activities and Nutrition Choices for Energy (BALANCE), a multilevel intervention administered through Parents as Teachers (PAT) and designed to reduce overweight in postpartum teens. The intervention will focus on the replacement of 'obesogenic' patterns (such as high soda intake, excess portion size, and sedentary activity) with 'energy' patterns (such as water consumption, appropriate portion size, and walking).


Eligibility Criteria:
Inclusion Criteria:

* between 12 to 20 years of age
* less than 1 year post partum
* current participant in Parents as Teachers

Exclusion Criteria:

* currently pregnant
A Study With GLPG1972 in Osteoarthritis Subjects

This is a randomized, double-blind, placebo-controlled, stratified, ascending dose, single center study, in three semi-sequential cohorts of 10 male and female subjects of nonchildbearing potential with Osteoarthritis (OA), administered GLPG1972 or placebo. Per cohort, 10 subjects will be randomized in a 4:1 allocation ratio to active treatment with GLPG1972 or matching placebo. In each cohort, OA subjects will be stratified for age (50- 64 years and 65-75 years) with a minimum of 2 of each sex per age group.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects of non-childbearing potential, 50-75 years of age on the date of signing the Informed Consent Form (ICF), inclusive extremes.
2. Diagnosis of OA (knee and/or hip) made by their physician based on symptoms, clinical signs and documented historical imaging evidence.
3. A body mass index (BMI) between 18.0 and 34.9 kg/m2, inclusive extremes.
4. Judged to be in age-appropriate good health by the investigator based upon the results of a medical history, physical examination, vital signs and 12-lead ECG, and fasting clinical laboratory profile.
5. Subjects with a stable chronic illness at least 3 months will be accepted subject to the investigator's judgment.

Exclusion Criteria:

1. Administration of intraarticular glucocorticoid injections or hyaluronan injections in the last 3 months prior to study screening.
2. Subjects who underwent or are on a waiting list for total hip or knee replacement and any other surgery planned during the study (up to Day 50).
3. Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization.
4. Positive serology for HBsAg or HCV antibody or history of hepatitis from any cause with the exception of hepatitis A.
5. History of or a current immunosuppressive condition.
6. Clinically significant serious, per investigator's discretion, and/or unstable illness in the 3 months before screening
7. Renal function with an estimated creatinine clearance \< 60 mL/min based on the Cockcroft-Gault formula. Retesting is allowed once (see Section 5.2).
8. Use of verapamil, diltiazem, amitriptyline, warfarin, acenocoumarol, phenobarbital and phenytoin, within 4 weeks before first study drug administration
9. Consumption of herbal medications that are strong inhibitors and/or inducers of CYPs (e.g., St. John's Wort) and grapefruit/grapefruit products, Seville oranges, or any poppy seed, within 7 days prior to the first study drug administration.
10. History of solid organ or hematopoietic cell transplantation.
11. History of malignancy within the past 5 years.
12. Clinically significant abnormalities detected on 12-lead ECG of either rhythm or conduction (e.g., QTcF ≥ 450 ms for males and QTcF ≥ 470 ms for females, or a known long QT syndrome).
13. Significant blood loss (including blood donation \[\> 450 mL\]), or transfusion of any blood product within 12 weeks prior to screening
COVID-19 Infection in Diabetic Patients

It was observed during the last period of COVID-19 pandemic that diabetic patients had a worse prognosis and more deteriorated clinical features than other patients

Diabetic patients infected with SAR-COV-19 were reported to have worse prognosis and faster deterioration in addition to higher rate for ICU admission when compared to other infected patients. In this study authors aim to investigate the certain cause for their case deterioration to be modified for better prognosis

Eligibility Criteria:
Inclusion Criteria:

Patients infected with COVID-19 male or female 30 years old or more inpatients

Exclusion Criteria:

* have othe comorbidities other than type 2 diabetes mellitus pregnant women below 30 years old
Oxygen Saturation in the Leg Musculature Affected by Peripheral Arterial Disease During Exercise on an Arm Ergometer

Studies with arm ergometer (AE) training have shown benefits in the functional capacity of patients with peripheral arterial disease (PAD) bypassing the main barrier to exercise in these patients, pain during walking exercise. The only study that proposed to investigate the mechanism involved in this adaptation observed that chronically training with EB promoted improvement in the oxygen saturation (StO₂) of the leg muscles during walking. However, how arm exercise could improve leg muscle StO₂ remains unknown.

The goal of this study is to analyze what happens during AE on the tissue oxygen saturation (StO₂) of the leg affected by PAD.


Eligibility Criteria:
Inclusion Criteria:

1. aged ≥ 50 years;
2. with PAD confirmed by clinical diagnosis and ankle-brachial index (ABI) \< 0.90 in one or both limbs;
3. experiencing symptoms of intermittent claudication (IC) during walking;
4. with a body mass index (BMI) not exceeding 30 kg/m²;
5. with medical clearance to participate in the project;
6. presenting calf skinfold thickness less than 20 mm due to interference of adiposity with the light penetration of the NIRS probe and finger oxygen saturation \> 95% to ensure that impaired pulmonary gas exchange does not affect the calf oxygen saturation measurements.
Youth Epilepsy and Successful Self-Management Intervention

This study is designed as a pilot test of the YESS! web-based intervention for adolescents with epilepsy. One hundred twenty participants will be given access to the intervention for a period of eight weeks. The investigators are testing the feasibility and acceptability of the the study procedures, measures and of the intervention itself. The study also evaluats the potential for impact on the users.

YESS! is a web-based self management program developed to enhance the motivation and skills of youth with epilepsy.

This clinical trial uses a pre-test, post-test design where all consenting participants are given access to the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age as above
* Epilepsy diagnosed by a physician
* Currently taking anti-seizure medications or use device
* Ability to understand and respond to questions about health and epilepsy
* Ability to utilize an internet based intervention website

Exclusion Criteria:
Everolimus, Cytarabine, and Daunorubicin in Treating Patients With Relapsed Acute Myeloid Leukemia

RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Everolimus may help cytarabine and daunorubicin work better by making cancer cells more sensitive to chemotherapy. Giving everolimus together with cytarabine and daunorubicin may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with cytarabine and daunorubicin in treating patients with relapsed acute myeloid leukemia.

OBJECTIVES:

Primary

* Determine the maximum tolerated dose of everolimus.
* Determine the toxicity of this regimen.

Secondary

* Assess the activation of PI3K/AKT and mTORC 1 in leukemic blasts.
* Evaluate the pharmacokinetics of everolimus at different concentrations.

OUTLINE: This is a multicenter study.

Patients receive primary induction therapy comprising daunorubicin hydrochloride IV on days 1-3, cytarabine IV over 24 hours on day 1, and oral everolimus on days 1 and 7. Patients with more than 5% blasts on day 15 receive a second induction course comprising daunorubicin hydrochloride IV on days 17 and 18 and cytarabine IV twice daily on days 17-20.

After completion of study therapy, patients are followed for 3 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

Inclusion criteria:

* Diagnosis of de novo or secondary acute myeloid leukemia meeting the following criterion:

  * Relapse \> 1 year after obtaining complete remission (any prior treatment allowed)

Exclusion criteria:

* Philadelphia chromosome-positive disease in blast crisis
* FAB M3, M6, or M7 disease

PATIENT CHARACTERISTICS:

Inclusion criteria:

* Life expectancy ≥ 4 weeks
* Transaminases ≤ 5 times normal
* Creatinine ≤ 2 times normal
* Bilirubin ≤ 3 times normal (except if visceral involvement present)
* Alkaline phosphatase or gamma-glutamyltransferase ≤ 5 times normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients of must use effective contraception during and for ≥ 28 days after completion of study therapy

Exclusion criteria:

* FEV1 \< 30%
* Active uncontrolled or viral pulmonary infection
* Serious psychiatric disorders not related to leukemia or any condition that would prohibit comprehension of the study
* HIV-positive
* Other concurrent malignancy except noninvasive skin cancer or carcinoma in situ
* Patients who are incarcerated or under supervision or trusteeship

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

* See Disease Characteristics

Exclusion criteria:

* Prior experimental medication within the past 4 weeks
Point-of-Choice Prompts to Reduce Prolonged Sitting Time at Work

The purpose of this study is to determine whether an on-screen prompt put on the work computer every 30 minutes is effective in getting office workers to reduce prolonged periods of sitting at work.

Prolonged bouts of uninterrupted time spent sitting is associated with indicators of poor health, independent of how physically active a person is. Many occupations are now sedentary, and are characterised by long periods spent sitting at a desk. Brief education on the benefits of standing regularly and breaking up prolonged sitting will be provided to participants, working at a Scottish University. One intervention group will additionally have software installed on their work computer which placed a prompt window in the centre of their screen for 1 minute every 30 minutes. The prompt will remind participants to stand-up and take a break, and the window cannot be removed or minimised.

Eligibility Criteria:
Inclusion Criteria:

* Employee of Glasgow Caledonian University
* Aged between 18 and 65 years
* Self-reported desk-based occupation
* Informed written consent provided
* Ability to stand unassisted

Exclusion Criteria:

* Any musculoskeletal condition which limits ability to stand regularly