cyrilzakka/clinical-trials huggingface dataset:
Fertility Study of Women With Chronic Inflammatory Rheumatism

Etiopathogenesis of Chronic inflammatory rheumatisms (CIR) includes genetic, autoimmune and environmental factors. Their impact on the quality of life is important, leading to a sometimes severe disability. Thus they are likely to affect female fertility through several mechanisms, including autoimmune since the association between immunity and fertility has already been demonstrated in other autoimmune diseases.

This study wants to evaluate and compare the birth rate between CIR and control group.

Data collection will be carried out using a questionnaire submitted to women in charge of the rheumatology department of the University Hospital of Toulouse and having agreed to participate:

* women with Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis or Chronic juvenile arthritis for the chronic inflammatory rheumatism group
* women with a mechanical rheumatic pathology for the control group

The primary endpoint was birth rate after spontaneous or induced pregnancy in patients who attempted to procreate, in the CIR group and in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Patient with Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Chronic juvenile arthritis, Chronic Inflammatory Rheumatism
* Patient diagnosed before the age of 40
* Patient having given her no opposition to her participation in research
* For the control group: patient not suffering from chronic inflammatory rheumatism, having consulted in Rheumatology for a mechanical pathology

Exclusion Criteria:

* Patient\> 40 years old at the time of diagnosis
* Patient with insufficient medical data (treatments)
Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of NNC0174-0833 in Subjects With Obesity or Overweight

This trial is conducted in The United States of America. The aim of this trial is to investigate Safety, Tolerability, Pharmacokinetics (the exposure of the trial drug in the body) and Pharmacodynamics (the effect of the investigated drug on the body) of Multiple Dosing of NNC0174-0833 in Subjects with Obesity or Overweight.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of non-childbearing potential (NCBP), aged 22-55 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 25.0 and 39.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess of adipose tissue, as judged by the investigator

Exclusion Criteria:

* History or presence of any clinically relevant respiratory, metabolic, renal, hepatic,gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or other major disorders including sleep apnoea or excessive sleepiness that might require medical attention
* History or presence of cardiovascular disease including stable and unstable angina, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, and heart failure
* History or presence of a disease being associated with impaired calcium homeostasis and/or increased bone turnover (e.g. Paget´s disease, osteoporosis)
* Male subject who is not surgically sterilised (vasectomy) and is sexually active with female partner(s) and is not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) of childbearing potential (Pearl Index below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period from screening until 3 months following administration of the last dose of investigational medical product
Preventing Postpartum Relapse to Smoking Using Yoga and Cognitive Behavioral Therapy: A Randomized Pilot Study

The purpose of this study is to develop strategies to maintain smoking abstinence initiated in pregnancy and prevent relapse in the postpartum period.

Many women quit smoking during pregnancy, but postpartum relapse rates are high, approximately, 50-80% (Van't Hof, et al). The majority of women who quit smoking during pregnancy resume smoking within the first 3 months postpartum (McBride, et al). The environmental risks of tobacco smoke on the newborn child can lead to acute respiratory infections, bronchitis, pneumonia, and SIDS. Several studies have tried to identify reasons for the high rates of relapse. Postpartum relapse has been attributed to decreased self-efficacy, the lack of effective coping strategies to resist temptation to smoke, and weight concerns (McBride, et al). Addictive behaviors such as smoking are learned behavioral means of coping. By learning new rules for dealing with problems, a behavior can be modified or unlearned. Physical exercise, when combined with cognitive behavioral therapy (CBT) as a smoking cessation treatment, is useful in the maintenance of smoking cessation in women. Yoga, as a form of exercise, has been shown to promote the desire to stop smoking and enhance subjective well-being and mood. Though untested in postpartum relapse prevention, yoga practice, when coupled with CBT, may address both mood and physiologic postpartum sensations that may be associated with the prevention of smoking relapse. Women are more apt to decrease or even stop smoking during pregnancy, and if successful in sustaining cessation, are likely to live longer.

This randomized exploratory pilot study will use a controlled parallel group design using smoking cessation yoga intervention and cognitive behavioral therapy. The study will include a total of 30 participants aged 18-45 years. Smoking status will be identified by self-report and carbon monoxide testing at enrollment. At randomization and following time points, smoking status will be identified by self-report and confirmed by carbon monoxide testing.

Eligibility Criteria:
Inclusion Criteria:

* Must have the ability to read, write, and understand English.
* Must have quit smoking during their current pregnancy.
* Must possess the desire to remain smoke-free after delivery.
* Obtain permission from obstetrician to participate in yoga.
* Must be reachable by telephone.
* If subject becomes pregnant again while in the study, she can still participate with written permission from her primary care physician.

Exclusion Criteria:

* Untreated hypertension.
* A history of: glaucoma, major depression, alcohol abuse or substance disorder, anorexia nervosa, or head trauma.
* Recent abdominal surgery (such as caesarean section).
Establishment of a Tissue Registry for Hepatocellular Carcinoma Specimens

The goal of the study is to establish a cancer registry to facilitate research and assist in the identification of additional risk factors for hepatocellular carcinoma. The main objectives are:

1. provide a mechanism to store the information about subjects with hepatocellular carcinoma
2. use of tissue samples for translational/further research purposes

The Establishment of a Tissue Registry for Hepatocellular Carcinoma biopsy specimens for genetic and histologic research (TIR-HCC) is a project aimed at addressing the high incidence rates of primary liver cancer in Armenia. This initiative seeks to establish a cancer registry to support research efforts and identify additional risk factors associated with hepatocellular carcinoma (HCC).

The study will involve patients of Armenian descent who exhibit clinical, biochemical, and imaging evidence of hepatocellular carcinoma. Data collection will include tissue and blood samples, which will undergo histologic and genetic analyses. Additionally, relevant clinical history, laboratory results, imaging findings, and gut microbiota profiles will be collected.

To ensure a comprehensive dataset, samples will be collected from eight institutions in Armenia. The project aims to accumulate data from a total of 500 patients, providing a substantial pool for research and analysis.

By establishing the TIR-HCC registry, researchers hope to contribute to the understanding of hepatocellular carcinoma and potentially identify new risk factors associated with the disease. The collected data will aid in advancing knowledge of HCC and guide future strategies for prevention, early detection, and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with biopsy-confirmed diagnosis of HCC
* Armenian descent
* Having given their signed Informed consent

Exclusion Criteria:

* Failure to obtain informed consent
Effectiveness of CARD for Improving School-Based Immunizations

Vaccination is estimated to have saved more lives in Canada than any other single intervention and is considered one of the most important advances in the prevention of disease. The process of vaccination, however, is stressful for individuals. School-based vaccinations in particular, are associated with high levels of fear and anxiety among students. This randomized cluster trial will implement a multi-faceted knowledge translation intervention called The CARD (C-Comfort A-Ask R-Relax D-Distract) System in school-based vaccinations and evaluate its effects on the experience of vaccination for students and implementation outcomes.

The investigators developed a multi-faceted knowledge translation intervention called The CARD System to provide a framework for delivering vaccinations at school that integrates evidence-based strategies to mitigate pain, fear and fainting and promotes a student-centred approach to vaccination. CARD addresses 2 components of the vaccination delivery program: 1) pre-vaccination day preparation and 2) vaccination day activities. In a small controlled clinical trial in a public health unit in Niagara, Ontario, the investigators demonstrated benefits of CARD on student symptoms during vaccination, including fear, and dizziness-precursor of fainting, and satisfaction with CARD by all stakeholder groups (students, public health staff, school staff and parents). This study will evaluate CARD in a large cluster trial in Calgary, Alberta. This trial is the final phase of a 3-phase project, whereby the first 2 phases involve developing an implementation plan for the local context and evaluating feasibility of implementation.

Eight community health centres that provide vaccination services to schools in their regions will be randomized in a 1:1 ratio to CARD or control (usual practices). Data will be collected for vaccination services carried out in grade 6 and grade 9 students in participating schools for the academic year 2019-2020.

Eligibility Criteria:
Inclusion Criteria:

* grade 6 and 9 students eligible for vaccination at school
* public health staff in community health centre involved in the study
* school staff in a participating school involved in school vaccination
* parent of a student eligible for vaccination at school

Exclusion Criteria:

- unable to understand and read English
Evaluation of the Functionality of a Fluid Filled Single Breast Pump

This study is an early (during the product development process) feasibility study. It shall evaluate the device design concept with respect to device functionality of a new fluid filled breast pump in a small number of subjects.


Eligibility Criteria:
Inclusion criteria:

* Female over 18 years
* Participant has an established milk flow, general rule: approx. 50 ml per breast per pumping session
* The participant is pumping at least 2 times a week
* The participant is 1-6 months after giving birth (postpartum) at the day of data assessment
* The participant agrees to pump or feed the last time a minimum of 3 hours before the start of the pumping sessions
* The participant agrees that the pumped breast milk cannot be fed to her infant (will be disposed)
* The participant agrees to photograph and video record the breast and upper body (no face)
* The participant agrees to the presence of up to 3 men in the room during the pumping session

Exclusion criteria:

* Participant or their baby is dependent on life-sustaining electric devices (e.g. heart pacemaker, insulin pump, etc.)
* Participant has an medical condition of the breast
* Participant is allergic to plastics or silicone
Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis

Two year study to determine the safety and efficacy of weekly 35 mg Risedronate doses in men with osteoporosis followed by a two year follow-up study.


Eligibility Criteria:
Inclusion Criteria:

* Documented osteoporosis of the femoral neck and lumbar spine

Exclusion Criteria:

* BMI greater than or equal to 35
Decitabine in Treating Patients With Myelodysplastic Syndrome

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of decitabine in treating patients with myelodysplastic syndrome.

OBJECTIVES: I. Determine the response of patients with myelodysplastic syndromes (including chronic myelomonocytic leukemia) to decitabine.

OUTLINE: This is an open label, multicenter study. Patients are stratified by disease (low risk myelodysplastic syndrome (MDS) vs. high risk MDS vs. chronic myelomonocytic leukemia). Patients receive decitabine as a 4 hour infusion every 8 hours on days 1-3. Treatment continues every 6-8 weeks for 4-6 courses. Patients are followed at 6 and 12 months.

PROJECTED ACCRUAL: Approximately 75 patients will be accrued for this study over 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven myelodysplastic syndrome Refractory anemia (RA) RA with ringed sideroblasts (RARS) RA with excess blasts (RAEB) RAEB in transformation Chronic myelomonocytic leukemia (CMML) RA and RARS: Platelet count less than 50,000/mm3 CMML: If WBC greater than 10,000/mm3, then must have at least 8% monocytes in the blood or marrow

PATIENT CHARACTERISTICS: Age: 15 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease Other: No active or uncontrolled infection Not pregnant or nursing Fertile patients must use effective contraception No other active cancer except skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than one prior chemotherapy regimen for myelodysplastic syndromes At least 3 weeks since chemotherapy and recovered No prior high-dose cytarabine (at least 0.5 g/m2 for at least 4 doses) Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Braden Pressure Ulcer Scale for Prediction of the Intensive Care Length of Stay

The aim of this study is to predict the length of intensive care unit stay of patients treated in a tertiary general intensive care unit with the help of the Braden risk assesment scale, which is used to predict the risk of pressure ulcers. The main question it aims to answer is:

* Does high Braden scales predict the long lenght of stay? Braden scales of patients admitted to the intensive care unit were recorded every day.

Intensive care units are specialized units where patients with multiple comorbidities are treated. The length of stay in intensive care varies according to the characteristics of the patient, the disease and the center. Prolonged intensive care stay causes an increase in mortality . It has been reported that the severity of the disease as well as the comorbidities of the patients contribute to prolonged stay . One third of patients with stay longer than seven days were evaluated as more fragile than before hospital admission. Prolonged intensive care length of stay leads to an increase in morbidity and mortality, bed demand and costs.

The Braden pressure ulcer scale was developed by Braden et al. in 1987 . Scoring is done under six different headings evaluating sensory perception, humidity, activity, mobility, nutrition and friction/cutting. It has been reported as an effective tool for evaluating pressure ulcer development in intensive care patients. In this scoring system, there are different assessment steps such as mobility, nutrition, sensory perception, etc., which allows the assessment of the functional capacity of the patients at the time of admission. In a study of elderly dementia patients, the Braden scale was found to be effective in predicting 90-day mortality. In a retrospective evaluation of patients with heart failure, the Braden scale was reported to predict 30-day mortality.

The aim of our study is to predict the length of intensive care stay by analyzing the Braden scales calculated on the day of hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Patients treated in intensive care
* Patients treated with diagnoses other than Covid-19
* Patients without missing data in the hospital electronic data system
* Patients hospitalized for more than 24 hours

Exclusion Criteria:

* Patients younger than 18 years
* Patients treated for Covid-19 disease
* Patients with missing data in the hospital electronic data system
* Patients hospitalized for less than 24 hours
Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence

Hyperphosphatemia in end-stage renal disease (ESRD) patients is a non-traditional risk factor for all-cause and cardiovascular mortality. Non-adherence to phosphate binders is as high as 74% in ESRD patients and has been shown to be most related to psychosocial factors including attitudes. There is limited data on the influence of attitudes and perceived autonomy support on phosphate binder adherence and these two psychosocial constructs can be positively influenced through the use of motivational interviewing skills to increase autonomous motivation. Furthermore, racial disparities are known to exist in ESRD however and there are still gaps, which exist in understanding the determinants of disparities in adherence in vulnerable patients with ESRD.

In this study, the investigators seek to determine the impact of motivational interviewing on phosphate binder adherence in diverse ESRD patients. The investigators will ask all the subjects to fill out surveys mainly regarding their attitudes; perceived providers' autonomy support and phosphate binder adherence. The investigators will administer motivational counseling to subjects in the intervention arm of the study, at baseline and 1 month after recruitment. The investigators will ask all the subjects to fill out the same surveys 2 months after recruitment and the investigators will compare subjects who underwent motivational interviewing to those who did not.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 years or older
* Receiving phosphate binder therapy currently
* English speaking

Exclusion Criteria:

* Non- English speaking
* Known diagnosis of psychosis or dementia, limiting ability to provide informed consent
* Any medical condition that precludes participation in the study including deafness, dying etc.
* Initial Morisky Medication Adherence score greater than 6
Substance Use and Eating Disorders : Food Craving and Addiction Transfer

Substance Use Disorder (SUD) and Eating Disorders (ED) are severe and persistent disturbances that are associated with significant harm. These two disorders have many clinical similarities, including craving and behavioral loss of control. Recently, craving for food has been described in newly abstinent patients with SUD. the aim of the study is to verify the hypothesis of addiction transfer based on common neurobiological mechanisms between substance craving and food craving, that postulates that food craving would correspond to an attempt to regulate substance craving (or vice versa).

The knowledge of existence of common addictive, neurobiological and clinical processes between substance use disorders and eating disorders has been a promising approach for a better understanding of the factors involved in the emergence and maintenance of these disorders. Several studies have shown that increased palatable food with high sugar or fat content causes brain neurochemistry changes similar to those observed after use of addictive drugs. Clinical and behavioral similarities concerning craving, loss of control and use as a coping strategy have also been highlighted. Craving is considered as a clinical marker of addiction and a potent predictor of relapse vulnerability. In substance addiction, the link between craving, use and relapse has been previously demonstrated in experimental and daily life studies. The main objective of this study is to examine the hypothesis of addiction transfer between Substance Use Disorders and Eating Disorders, according to which food craving for palatable foods would correspond to an attempt to regulate substance craving or vice versa. One assumption is that food intake could be used to alleviate craving for substances in patients hospitalized for substance use disorder. The secondary objective is to explore psychopathological, addictive, and medical similarities between substance use disorder and eating disorder participants. Included patients (group 1: substance use disorder participants and group 2: eating disorder) will be asked to answer different self-questionnaires, as well as a clinical psychiatric (MINI) and cognitive (MoCA) assessment.

Eligibility Criteria:
Inclusion Criteria:

* DSM-5 diagnostic criteria for substance use disorder/behavioral addiction (gambling) or an eating disorder (Anorexia nervosa, Bulimia nervosa or Hyperphagia access).
* Begin treatment in addiction complex care unit, located in inter-hospital unit Charles Perrens Hospital and Bordeaux University Hospital
* Non-opposition formulated

Exclusion Criteria:

* Severely impaired physical and/or mental health that, according to the investigator, may affect the participant's compliance with the study and understanding of assessment tools
* Trouble in understanding/writing French
* Hospitalization for less than 3-weeks for patients with substance use disorders or behavioral addiction (gambling)
* Individuals participating in another study that includes an ongoing exclusion period.
* Be under guardianship
* Pregnant and/or lactating woman