cyrilzakka/clinical-trials huggingface dataset:
Alcohol and Women : Screening in General

The alcohol consumption of adults has been decreasing in France since the sixties. When focusing on the particular case of women, this trend goes on the opposite direction. In addition, the impact of drinking alcohol involves an increased severity in women in comparison to men. Furthermore, women consult less often doctors about their alcohol problem due to stigmatisation. Finally, as alcohol consumption is a major public health issue (second preventable cause of death), the aim of this study is to propose an earlier screening of women with alcohol use disorders (AUD) in general medicine.

To improve the screening of women with AUD in general médicine, from their perceptions and experiences, and to create a screening tool to general practitioners.

The chosen method is a qualtitative study through semi-structured interview with women with AUD.

A qualitative assessment of these individual interviews could show various topics.

Eligibility Criteria:
Inclusion criteria:

- over 18 years old alcoholic women, with one or several addiction, from all social class.

Exclusion criteria:

- not being able to answer the questionnaire
A Study to Evaluate the Pharmacokinetics of AFQ056 in Subjects With Hepatic Impairment Compared to Healthy Subjects

This study will assess the pharmacokinetics of AFQ056 in subjects with mild, moderate, severe hepatic impairment compared with healthy control subjects.


Eligibility Criteria:
Inclusion Criteria:

* Groups 1, 2, 3 and 4 (all subjects)
* Male and female Caucasian subjects
* Group 1, 2 and 3 (subjects with hepatic impairment)
* Subjects must satisfy the criteria for hepatic impairment as evidenced by a Child-Pugh score of A, B or C at screening
* Group 4 (healthy subjects)
* Each healthy subject must match in age (±8 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1, 2 or 3.

Exclusion Criteria:

* Groups 1, 2, 3 and 4 (all subjects)
* Use of any tobacco products from 1 week prior to cotinine screening assessments until study completion.
* Group 1, 2 and 3 (subjects with hepatic impairment)
* History of drug or alcohol abuse within 3 months prior to screening
* History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases within 1 month prior to study drug administration except for hepatic impairment or any other disease associated with this underlying condition.
* Any surgical or medical condition other than hepatic impairment which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study.
* History or presence of encephalopathy within 6 months prior screening (except for subjects in Groups 2 and 3).
* Documented presence of a porto-systemic shunt.
* Documented presence of esophagus varices (stage III or IV).
* Group 4 (healthy subjects)
* History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases.
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study. History of drug or alcohol abuse within 12 months prior to screening, or evidence of such abuse as indicated by the laboratory assays conducted during screening and baseline.
* History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening.

Other protocol-defined inclusion/exclusion criteria may apply
Effects of Empagliflozin on Exercise Capacity and Left Ventricular Diastolic Function in Patients With Heart Failure With Preserved Ejection Fraction and Type-2 Diabetes Mellitus

Patients enrolled into the study will be randomly allocated either to Empagliflozin group or control group. In the Empagliflozin group patients will be receiving standard care + Empagliflozin 10 mg o.d., in the control group patients will be receiving standard care without sodium glucose contransporter 2 (SGLT2) inhibitors.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females aged 45 to 80 years at screening
2. Diagnosis of type-2 diabetes mellitus with stable glucose-lowering background therapy for at least 12 weeks
3. HbA1c ≥ 6,5% and ≤ 10% at screening
4. Diagnosis of HFpEF which includes:

   * Symptoms ± signs (as defined in 2016 European Society of Cardiology guidelines for the diagnosis and treatment of acute and chronic heart failure)
   * Ejection fraction ≥ 50% (by Simpson)
   * Increased LV filling pressures at rest or during exercise determined by echocardiography (LV diastolic dysfunction grade II/III and/or positive diastolic stress test) \[according to American Society of Echocardiography and European Association of Cardiovascular Imaging (ASE/EACVI) Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography, 2016\]
5. Signed and dated informed consent

Exclusion Criteria:

1. Pretreatment with empagliflozin or other SGLT-2 inhibitor within the last 2 months
2. Type-1 diabetes mellitus
3. NYHA classification IV or acute decompensated heart failure at screening
4. Impaired renal function, defined as eGFR \<30 ml/min/1.73 m² of body-surface-area (CKD-EPI)
5. Systolic blood pressure \> 180 mmHg or \< 90 mmHg
6. Permanent atrial flutter or atrial fibrillation
7. Other conditions that may be responsible for impaired diastolic function such as hypertrophic/restrictive cardiomyopathy, constrictive pericarditis and etc.
8. Anemia (Hb \< 100 g/l)
9. Myocardial infarction, coronary artery bypass graft surgery within the last 3 months
10. Stroke or TIA within the last 3 months
11. Indications of liver disease
12. Acute genital infection or urinary tract infection
13. Pregnancy
14. Additional exclusion criteria may apply
Observational Study Evaluating Etanercept (Enbrel®) In Subjects With Plaque-Type Psoriasis In Usual Care Settings

This prospective observational cohort study will assess the average duration of the drug free interval between etanercept treatment cycles in usual care settings in Germany.

Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Eligibility Criteria:
Inclusion Criteria:

* Subjects with moderate to severe plaque psoriasis on etanercept treatment according to the Summary of Product Characteristics (SmPC), and applicable local guidelines
* Subjects for whom the decision has already been made to initiate treatment with etanercept

Exclusion Criteria:

* Sepsis or risk of sepsis
* Current or recent infections, including chronic or localized, e.g. tuberculosis (TB) infection
* Vaccination with live vaccine in last 4 weeks, or expected to require such vaccination during the course of the study
* Pre-existing or recent onset CNS demyelinating disease.
* Class III or IV congestive heart failure as defined by the New York Heart Association classification or uncompensated congestive heart failure.
* Previous or ongoing treatment with etanercept
* Participation in other clinical or observational studies.
* Patients with psoriatic arthritis requiring continuous etanercept treatment.
Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial

The purpose of this study is to examine adherence to cardio-oncology consultation.

The purpose of this study is to evaluate patient participation in a plan to improve heart health after radiation therapy by having a cardio-oncology assessment early during cancer treatment. Cardiologists and cancer doctors will review any cardiovascular risk factors (heart conditions, hypertension, bleeding disorders, smoking history, obesity, cholesterol and diabetes) and develop a personalized treatment plan. In addition, the study will evaluate use of wearable devices such as a FitBit, and remote EKG (Omron EVOLV) and blood pressure monitoring (AliveCor KardiaMobile) devices to monitor participant's health. Blood will be drawn at three separate timepoints for biomarker testing of heart injury, aging, inflammation and metabolism.

Study visits will occur at baseline, weekly during radiation therapy, 6 weeks and 3 months after completion of radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Any stage (I-IV) malignancy being treated with high dose (≥30 Gy) radiotherapy where the heart is in the treatment field.
* Have Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
* Planning to receive standard of care radiotherapy treatments.
* Access to a smart device that has the capability to sync to the devices.
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
* Ability to read, write and understand English.

Exclusion Criteria:

* Known allergy to surgical steel or elastomer/rubber.
* Heart attack within 6 months prior to study enrollment.
* Severe and/or active scleroderma or systemic lupus erythematosus.
Efficacy of Audio-Visual-Perception-Enhancement (AVWF®) Method in Chronic Pain Patients

It is anticipated that Audio-Visual-Perception-Enhancement (AVWF®) method leads to pain reduction and a decrease of inflammatory markers in chronic pain patients. Also an improvement of quality of life, self-perceived disability and depression in chronic pain patients is expected.


Eligibility Criteria:
Inclusion Criteria:

* chronic low back pain with a numeric rating scale of pain \>= 4 for \> 6 month
* patients \>18 years

Exclusion Criteria:

* psychosis
* drug addiction
* pension process
* pregnant women
* epilepsy
Translation and Implementation of the Dutch VVAS Score in Clinical Practice

The aim of this study is to translate and introduce a cross-cultural adaptation of The Visual Vertigo Analogue Scale (VVAS). E. Dannenbaum et al developed the VVAS in order to diagnose visual vertigo (VV). VV is dizziness caused by visual stimuli such as scrolling through a computer screen or walking through crowds of people or supermarket aisles.

The Visual Vertigo Analogue Scale (VVAS) was developed by E. Dannenbaum et al in 2011 to diagnose visual vertigo. It is a nine-item analogue scale in which the subjects can rate their symptoms' intensity. The symptoms can be categorized as None (0), Mild (0.1-40), Moderate (40.01-70), or Severe (70.01-100). The VVAS is already available in English and French but a Dutch version does not yet exist. In this study, we would like to translate and introduce a cross-cultural adaptation of the VVAS into Dutch for use with vestibular patients in Belgium.

Eligibility Criteria:
Inclusion Criteria:

* All patient with chronic vertigo (\>3 years) will included
* Interpretation of the VVAS is be possible
* 18-75 year

Exclusion Criteria:

* Unable to read Dutch
* Single episode of vertigo
* \> 75 year
* Minors
* When no interpretation of the VVAS is possible (e.g. too young, dementia)
A Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants With Sickle Cell Disease

This study is an open-label study to evaluate the safety of long-term administration of inclacumab in participants with sickle cell disease (SCD). Participants in this study will have completed a prior study of inclacumab.

The study will include approximately 520 adult and adolescent participants (≥ 12 years of age) with SCD.

All participants will receive inclacumab 30 mg/kg administered intravenously every 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

Participants who meet all the following criteria will be eligible for study enrollment:

1. Male or female participant with SCD who participated and received study drug in a GBT-Sponsored inclacumab clinical study.
2. Participant has completed the originating inclacumab study within 30 calendar days of the Day 1 Visit. Participants who discontinued study drug in the originating study due to a non-study drug-related AE, but who remained on study, may be eligible for treatment in this study provided the AE does not pose a risk for treatment with inclacumab.
3. Female participants of childbearing potential are required to have a negative urine pregnancy test prior to dosing on Day 1.

   Note: Female participants who become of childbearing potential during the study must be willing to have a negative urine pregnancy test to remain in the study.
4. If sexually active, female participants of childbearing potential must consistently use highly effective methods of contraception consistently throughout the study and for at least 165 days after the last dose of study drug. If sexually active, male participants must use barrier methods of contraception until 165 days after the last dose of study drug.
5. Participant has provided written informed consent/assent. For underage participants, both the consent of the participant's legal representative or legal guardian and the participant's assent (where applicable) must be obtained based on local requirement.

Exclusion Criteria:

Participants meeting any of the following exclusion criteria will not be eligible for study enrollment:

1. Female participant who is breastfeeding or pregnant.
2. Participant had an infusions-related reaction (IRR) in the originating inclacumab clinical study.
3. Participant withdrew consent from the originating inclacumab clinical study.
4. Participant was lost to follow-up from the originating inclacumab clinical study.
5. Participant has any medical, psychological, safety, or behavioral conditions that, in the opinion of the Investigator, may confound safety interpretation, interfere with compliance, or preclude informed consent.
Atomoxetine Versus Placebo for Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents With Autism Spectrum Disorder

The purpose of this study is to determine whether atomoxetine is effective in reducing ADHD (Attention Deficit/Hyperactivity Disorder) symptoms in children and adolescents with ASD (Autism Spectrum Disorder).


Eligibility Criteria:
Inclusion Criteria (most important):

* ASD (autistic disorder or Asperger's disorder or Pervasive Developmental Disorder - Not Otherwise Specified \[PDD NOS\])
* Criteria A through D for Attention-Deficit/Hyperactivity Disorder (ADHD)
* At least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the ADHD Rating Scale-IV-Parent Version
* Intelligence quotient (IQ) score \> 60

Exclusion Criteria (most important):

* weight under 20 kg
* Patients who meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) criteria for ASD other than Autistic Disorder, PDD-NOS or Asperger's Disorder;history of Bipolar I or II disorder, schizophrenia, another psychotic disorder, substance abuse;Have a significant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, or seizure disorder identified by history, physical examination, or laboratory tests; Patients who have taken (or are currently taking) anticonvulsants for seizure control.
* patients at serious suicidal risk.
* Contraindication to the use of atomoxetine
* Patients who in the investigator's judgment are likely to need psychotropic medications apart from the drug. Patients who at any time during Study Period II are likely to begin a structured psychotherapy, likely to require hospitalization (i.e. in-patient treatment) or likely to be dismissed from in-patient treatment. Psychotherapy (including hospitalization) initiated at least 2 months prior to study participation is acceptable; however, after study participation has begun, only during Study Period III supportive or educational therapy is permitted.
Training in Ataxia - Individuals With Degenerative Cerebellar Diseases

Balance and aerobic training show promise as treatments for degenerative cerebellar diseases, but the neural effects of both training methods are unknown. The goal of this project is to evaluate how each training method impacts the brain, and particularly, the degenerating cerebellum. Various neuroimaging techniques will be used to accomplish this goal and test the hypothesis that balance training impacts brain structures outside the cerebellum whereas aerobic training causes more neuroplastic changes within the cerebellum.

Degenerative cerebellar diseases are a group of disorders that cause severe disability and can be fatal. There are currently no known disease-modifying treatments available for use, and there is a critical need to find treatments that slow disease progression and allow affected individuals to live more functional lives. Balance and aerobic training show promise as treatments for degenerative cerebellar diseases, but the neural effects of both training methods have not been thoroughly investigated. It is crucial to understand how the training impacts the brain, and particularly the cerebellum, in order to determine if one training method is better at slowing disease progression than the other. The goal of this proposal is to compare the neural effects of balance versus aerobic training in individuals with degenerative cerebellar diseases. The investigator hypothesizes that aerobic training causes neuroplastic changes within the cerebellum whereas balance training causes improvements for people with cerebellar degeneration by impacting brain structures outside the cerebellum. If this hypothesis is true, aerobic training may have more influence on disease progression than balance training as it directly impacts the cerebellum.

To investigate the hypothesis, various neuroimaging techniques will be used. In AIM 1, the investigator will compare cerebellar volume before and after the participants perform either 6-months of balance or aerobic training. In AIM 2, the investigator will investigate whether neural changes have clinical significance by correlating cerebellar volume changes with clinical measures of ataxia. Finally, for AIM 3, the investigator will use diffusion tensor imaging and resting state fMRI scans to examine how both training methods impact cerebellar microstructure and functional cerebellar connections. The investigator hopes that a detailed understanding of how each training method impacts the cerebellum will lead to more targeted training regimens with the goal of slowing disease progression of these devastating diseases.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with spinocerebellar ataxia
* Cerebellar atrophy on MRI
* Prevalence of ataxia on clinical exam
* Ability to safely ride a stationary exercise bike

Exclusion Criteria:

* Other neurologic conditions
* Heart disease
* Cognitive impairment
* Medical instability
A Safety and Efficacy of CCRT With Paclitaxel as Adjuvant Therapy to Post-Operative Advanced Endometrial Cancer Patients

The purpose of this study is to determine whether post-operative concurrent chemoradiation with paclitaxel is effective and safe in the treatment of high risk postoperative endometrial cancer patients.

Postoperative radiotherapy (RT) is the most used adjuvant treatment in high risk endometrial cancer (HREC), and it appears to reduce the incidence of pelvic relapses but doesn't seem to improve survival. Paclitaxel (P) has shown in vitro and clinical activity against endometrial cancer, and it is also a potent radiosensitizer by blocking dividing cells in G2/M phase. This study is to evaluate the efficacy and safety of a treatment with concomitant weekly chemotherapy with paclitaxel and RT in high risk advanced endometrial cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients undertaken total hysterectomy, bilateral salpingoophorectomy, washing cytology, pelvic and paraaortic lymph node dissection
* Patients must have the diagnosis of endometrioid type adenocarcinoma with stage III, IV.
* Patients must have a GOG performance of 0, 1, or 2.
* Patients must have expected life span over 6 months.

Exclusion Criteria:

* Patients with peripheral neurotoxicity over grade 2 in CTC criteria.
* Patients with history of chemotherapy or radiation treatment.
* patients with history of arrhythmia,congestive heart failure.
* Patients with intractable infection.
Reducing the Negative Effects of Surgical Conditions Use of Double Layer Mask Against Electrocautery With Smoke Filter

This study was conducted to determine and compare the effectiveness of the smoke filtering electrocautery device used to reduce the negative effects of surgical smoke and the use of a double layer mask.

The research was conducted as a randomised controlled experimental study. The research was collected between November 2023 and February 2024 in Atatürk University Health Research and Application Centre Operating Theatre unit. Data were collected using the Personal Information Form, Specified Health Problems Questionnaire, and the Practice Record Form to record blood gas laboratory results. The study was conducted with 90 (30 control, 30 double mask, 30 device) operating theatre workers. The population of the study consisted of Atatürk University Health Practice and Research Hospital Operating Theatre unit employees between November 2023 and February 2024. In this study, a priori power analysis was performed to determine the sample size. In the power analysis, the sample of the study consisted of a total of 90 people, 30 people in the group using cautery device with smoke filtering system, 30 people in the group using double masks and 30 people in the control group, with an effect size of 0.5%, which is the medium effect size according to Cohen, an error margin level of 0.05% and a confidence interval of 0.95%, with a 95% population representativeness.

Eligibility Criteria:
Inclusion Criteria:

* people over the age of 18.
* People who agreed to participate in the study,
* who have been working in the operating theatre for at least one year.
* people who do not have chronic diseases Voluntary personnel who volunteered to co-operate were included in the study.

Exclusion Criteria:

* People who did not agree to participate in the study,
* persons who have been working in the operating theatre for less than one year
* people with chronic diseases,
* people who withdrew from the study before all data were collected
* Personnel whose laboratory results could not be analysed were excluded from the study.