cyrilzakka/clinical-trials huggingface dataset:
Taking Account of Inobservable Periods in Longitudinal Drug Treatment Follow-up

The question of the inclusion of periods of interruptions and periods unobservable has been studied as part of medico-administrative databases. However, the specificity of the health insurance databases justify the realization of dedicated methodological research. A thorough knowledge of the purpose of these data, how they collect and restitution is an essential prerequisite to carry out this work.

One type of scheme cohort exposed/unexposed led to the formulation of a finding on the basis of the comparison between the exposure groups. However, this traditional approach has the major drawback of neglecting the changing nature of drug exposure, and therefore fails to take into account any changes or interruptions doses. Approaches to take into account the time dependent variables were developed. These allow to take into account any interruptions. However, as part of study on health databases, sometimes we do not have the status in relation to the exhibition on the entire monitoring period. This is for example the case during hospitalization. The bias generated by the failure to take account of these periods ("non measurable time bias") can be problematic when a long exposure and chronic disorders require hospitalization.


Eligibility Criteria:
General Inclusion Criteria:

* Beneficiaries of all social security regimen with a minimum of one year of data in general sample of beneficiaries

Group expose to benzodiazepine :

* Exposition to at least one benzodiazepine or anxiolytic

Group antidepressants and anxiolytics and hypnotics non benzodiazepines :

* Exposition to at least one antidepressants and anxiolytics and hypnotics non benzodiazepines

Control group :

- Patient having a medical consultation without prescription of interest

Exclusion Criteria:

* Non incident patient : Patient having a prescription of benzodiazepines, clonazepam, tetrazepam, antidepressants, anxiolytics ou hypnotics non benzodiazepine during the last 12 months before index date
Effectiveness of Breathing Exercises During the Second Stage of Labor

To determine effectiveness of breathing exercises for pregnant women during the second stage of labor on maternal pain, duration of labor, dyspnea, oxygen saturation (SPO2) and the first-minute Appearance, Pulse, Grimace, Activity and Respiration (APGAR) scores

This study is about to determine effectiveness of breathing exercises for pregnant women during the second stage of labor on maternal pain, duration of labor, dyspnea, oxygen saturation SPO2 and the first-minute Appearance, Pulse, Grimace, Activity and Respiration (APGAR) scores.

Two sessions will be given to pregnant women in Intervention group. One session breathing exercises training will be given during first stage of labor by the investigator. During training all participants in Intervention group will be instructed to perform breathing exercises during the second stage of labor. The main components of breathing exercises during training will be as fellows (A) First, fill your stomach and then your lungs with air while breathing in; (B) Feel the expansion in the stomach; (C) Make sure the muscles from your stomach to your knee are relaxed, as if you are urinating while breathing out; (D) When there is pain, perform deep abdominal breathing exercises, and take a deep breath in and hold as much as you can; (E) Try to push the baby downward; (F) You can do it by holding your breath or breathing out quite slowly from your mouth; (G) The most important point in this stage is that you should not fill up the stomach with air, and you should push downward to deliver the baby; (H) You should continue the pushing until the pain is relieved. The participants will be observed during second stage of labor and their breathing will be monitored.

1. During the second stage of labor maternal labor pain will be assessed by Visual Analogue Scale.
2. Duration of second stage of labor will be counted by turning on the stop watch on the start of second stage and it will be stopped at the end when baby will be delivered.
3. Dyspnea will be monitored by dyspnea scale after performing breathing exercises during second stage of labor.
4. Oxygen saturation will be monitored by pulse oximeter during second stage of labor.
5. APGAR score of newborn will be marked in 1st minute after the birth.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant females
* Gestational age ranging between 37 and 42 weeks

Exclusion Criteria:

Women using analgesics or anesthetics, Women with clinical instability Women with psychiatric disorders
The Role of Trimetazidine on Right Ventricle Function in Pulmonary Arterial Hypertension

The study will evaluate the effect of trimetazidine versus placebo in addition to standard pulmonary arterial hypertension regime on right ventricular function in pulmonary arterial hypertension patients.

Right ventricular dysfunction is the worst mortality predictor in pulmonary arterial hypertension (PAH). Recent study has described that approximately 25% of PAH patients will developed into right ventricular failure despite therapeutic reduction of pulmonary vascular resistance. Subsequently, several studies have shown that fatty acid accumulation in right ventricle was inversely correlated with right ventricular function in PAH patients. Several PAH animal studies have revealed that metabolic glucose oxidation impairment through increased aerobic glycolysis, mitochondrial dysfunction, and lipotoxicity play significant role in right ventricular failure. Moreover, several pulmonary hypertension animal studies have demonstrated the benefit of partial fatty acid inhibitor such as trimetazidine on right ventricle function. It was hypothesize that trimetazidine improved right ventricular function through indirect effect of increased glucose oxidation by blocking the Randle cycle. Therefore, we hypothesize that trimetazidine can improve right ventricular function in pulmonary arterial hypertension patients.

Eligibility Criteria:
Inclusion Criteria:

* Pre-capillary Pulmonary Hypertension patients assessed by right heart catheterization
* Signed informed consent

Exclusion Criteria:

* Patient belonging to post-capillary, Isolated post-capillary, or combined post -capillary and pre-capillary pulmonary hypertension according to 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension.
* Moderate to severe chronic pulmonary obstructive disease
* Right Ventricular Ejection Fraction \> 45% assessed by cardiac magnetic resonance.
* Documented left ventricular dysfunction with left ventricular ejection fraction \< 50% assessed by cardiac magnetic resonance.
* Severe renal impairment (Serum creatinine \> 2.5 mg/dL, eGFR \< 30ml/min/1.73 m\^2, or routine dialysis treatment).
* Malignant arrhythmia such as total atrioventricular block or ventricular fibrillation or unstable ventricular tachycardia.
* Patients who are receiving or have been receiving any investigational drugs within 1 month before the baseline visit
* Acute or chronic impairment (other than dyspnea) limiting the ability to comply with study requirements
* Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements
* Females who are lactating or pregnant or those who plan to become pregnant during the study
* Known Parkinson disease
* Known hypersensitivity to any of the drug formulation
Comparison of LMA Proseal and LMA Supreme for Efficient Ventilation During Lateral Positioned Laparoscopic Surgeres

The LMA Proseal and LMA Supreme are the third generation of LMA with potential advantages over the classic LMA.Several publications have reported the successful, safe use of Laryngeal Mask Airway devices in patients undergoing laparoscopic surgery. However, there have been no studies that have examined the application of LMA in patients during lateral positioned laparoscopic surgery. The aim of this study is to observe the safety and efficacy when LMA Proseal and LMA Supreme used in lateral positioned laparoscopic surgery under general anesthesia.

We undertook a single-blind, parallel-group, randomized controlled trial.The patients were randomized to either LMA Proseal group or LMA Supreme group by computer generated allocation.

The patients were scheduled for elective lateral positioned laparoscopic surgery, such as laparoscopic radical nephrectomy, laparoscopic renal cyst decortication (LRCD) or laparoscopic adrenalectomy.Inclusion criteria for the patients were: Aged\>18 years, ASA physical status grade I - Ⅲ and body mass index ≤30 kg.m-2. Exclusion criteria were: anticipated difficult airway (e.g., Modified Mallampati Class IV, oropharyngeal pathology), severe cardiopulmonary disease, increased risk of regurgitation and aspiration (e.g., gastro-esophageal reflux disease, and pregnant patients), and retroperitoneal laparoscopic procedures.

Eligibility Criteria:
Inclusion Criteria:

* The patients belong to ASA physical status grade I and Ⅲ, aged above 18 years and body weight less than 30 kg/m2,who underwent elective laparoscopic urology surgery in the lateral position.

Exclusion Criteria:

* The patients with anticipated difficult airway (e.g., Modified Mallampati Class IV, oropharyngeal pathology), severe cardiopulmonary disease, increased risk of regurgitation and aspiration (e.g., gastro-esophageal reflux disease, and pregnant patients), and retroperitoneal laparoscopic procedures.
Effect of Momordica Charantia Administration on Anthropometric Indicators in Patients With Obesity

Momordica charantia has shown to exert anti-obesity effects through numerous mechanisms of action described in preclinical studies. Important reductions in body weight and other anthropometric indicators have been reported in clinical trials. However, these beneficial effects of Momordica charantia on obesity have been observed mainly in type 2 diabetes mellitus patients. The purpose of this study is to evaluate the effect of Momordica charantia administration on anthropometric indicators in patients with obesity.

A randomized, double-blind, placebo controlled clinical trial is carried out in 24 patients with obesity according to the body mass index.

Patients are assigned to two different arms: one group receives Momordica charantia, 2 capsules with 500 mg twice daily before breakfast and dinner for 12 weeks or placebo, under the same scheme of treatment.

Body weight, body mass index, waist circumference, body fat percentage and other clinical and laboratory parameters are evaluated.

This protocol is approved by a local ethics committee and written informed consent will be obtained from all volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of obesity type I according to body mass index (IMC: 30.0 - 34.9 kg/m2)
* Body weight without variations above or under 5% in the last three months before entering the study
* Fasting plasma glucose: \<126 mg/dL
* Total cholesterol: \<240 mg/dL
* Triglycerides: \<400 mg/dL
* Women in childbearing years must have a contraceptive method
* Letter of consent and release signed by each patient

Exclusion Criteria:

* Women with confirmed or suspected pregnancy
* Women under lactation and/or puerperium
* Known uncontrolled renal, hepatic, cardiovascular or thyroid disease
* Physical impossibility for taking pills
* Known hypersensibility to the Momordica charantia or placebo
Health and Psychological Outcomes of Lifestyle Versus Traditional Physical Activity

This study is a comparison of the traditional prescription versus the lifestyle exercise prescription in sedentary adults over 6 months. Biological and psychological parameters will be assessed over the 6 month study. Biological indicators will be assessed pre and post including body composition, muscular strength, endurance, and flexibility, aerobic fitness, and blood tests. Psychological parameters will be assessed pre, mid, and post including self-efficacy, motivation, need satisfaction, physical self-description, leisure-time exercise, as well as all constructs from the thepry of planned behaviour.


Eligibility Criteria:
Inclusion Criteria:

* 25-65 years old
* exercise less than twice per month in the preceeding 6 months
* physician consent to participate

Exclusion Criteria:

* health problems
* exercise more than twice per month in the preceeding 6 months
Comparison of Motion and Comfort for Thoracolumbosacral Orthoses - Group 2

The study will measure and compare range of motion (ROM), motion during simulated activities of daily living ADL), tissue interface pressure (TIP), muscle activation (EMG), and trunk stiffness and damping measurements (TSD) for two pairs of back braces: Postural TLSO (456), and TLSO (464).


Eligibility Criteria:
Inclusion Criteria:

* BMI \< 40
* English speaking
* Subjects who have read and signed IRB approved informed consent for this study
* Of appropriate body size for back brace per instructions for use

Exclusion Criteria:

* History of back pain or back injury requiring medical care within the previous 12 months
* History of spinal surgery, physical or chiropractic therapy of the back
* History of spinal spondylosis or osteoporosis
* Pregnant
* Currently Incarcerated
High-Intensity Focused Ultrasound Focal Ablation in Treating Patients With Progressive Prostate Cancer

RATIONALE: High-intensity focused ultrasound focal ablation uses high-energy sound waves to kill tumor cells.

PURPOSE: This phase II trial is studying the side effects of high-intensity focused ultrasound focal ablation and to see how well it works in treating patients with progressive prostate cancer.

OBJECTIVES:

Primary

* To evaluate the side effects of high-intensity focused ultrasound (HIFU) ablation in men with non-metastatic progressive prostate cancer.
* To evaluate the quality of life of patients treated with this regimen.

Secondary

* To determine the success of index lesion ablation with HIFU at 6 months after treatment by demonstrating the absence of cancer in the treated or ablated area by transrectal ultrasound biopsy.
* To evaluate the prostate-specific antigen kinetics after index lesion ablation in patients treated with this regimen.
* To evaluate the proportion of men who require androgen blockade at 12 months of follow-up.

OUTLINE: Patients undergo focal ablation with high-intensity focused ultrasound (HIFU) ablation on day 1. Treatment may repeat at 6 months in patients with progressive disease.

Blood samples and prostate biopsies are collected periodically for further analysis.

Patients complete questionnaires (IPSS, IPSS-QoL, ICS, IIEF-5, and FACT-P) at baseline and periodically during study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed prostate cancer by transrectal or transperineal template prostate biopsies

  * Stage ≤ T3bN0M0
  * Gleason grade ≤ 8
  * Serum PSA ≤ 20 ng/mL
  * Bone scan- or cross-sectional imaging-negative for metastatic or nodal (outside prostate) disease
  * No metastatic disease and/or nodal spread by CT scan or MRI
* Index lesion or other secondary lesions with a volume ≥ 0.5 cc by MRI
* No prostatic calcification and cysts (on transrectal ultrasound) that would interfere with effective delivery of therapy

PATIENT CHARACTERISTICS:

* Able to tolerate a transrectal ultrasound
* Not allergic to latex
* Fit for major surgery as assessed by a consultant anaesthetist
* Able to have MRI scanning (i.e., none of the following conditions: severe claustrophobia, permanent cardiac pacemaker, metallic implant, etc.)

PRIOR CONCURRENT THERAPY:

* No prior radiotherapy
* No androgen suppression and/or hormone treatment within the past 12 months
* No prior significant rectal surgery preventing insertion of transrectal high-intensity focused ultrasound (HIFU) probe (decided on the type of surgery in individual cases)
* No prior transurethral resection of the prostate (or equivalent procedures) within the past 2 years
* No prior HIFU, cryosurgery, thermal, or microwave therapy to the prostate
Biomarker-Integrated Umbrella, Advanced Gastric Cancer

In-depth understanding of molecular characteristics of gastric cancer enabled us to realize personalized medicine with targeted agents in gastric cancer treatment.

The investigators initiated open-label, randomized, controlled phase II, multi-arm trial comparing targeted therapy based on tumor molecular profiling with standard paclitaxel therapy as second line treatment.

In-depth understanding of molecular characteristics of gastric cancer enabled us to realize personalized medicine with targeted agents in gastric cancer treatment.The investigators initiated open-label, randomized, controlled phase II, multi-arm trial comparing targeted therapy based on tumor molecular profiling with standard paclitaxel therapy as second line treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed locally advanced or metastatic gastric cancer and gastroesophageal junction cancer
2. Eastern Cooperative Oncology Group performance status of 0 to 1
3. Male or female; ≥ 19 years of age
4. On or progression after 1st line palliative chemotherapy
5. Subjects with evaluable lesion (using RECIST 1.1 criteria)
6. Subjects who meet the following criteria:

   * Absolute neutrophil count ≥ 1000 /µL
   * Platelet count ≥ 75,000/ µL
   * Serum creatinine \< 1.5 x upper limit of normal or Creatinine clearance ≥60 mL/min
   * aspartate aminotransferase and alanine transaminase 3 x upper limit of normal

Exclusion Criteria:

* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
Nutrition, Exercise, and Technology for Weight Loss

The purpose of this study is to evaluate whether a social support-enhanced, technology-based, behavioral weight control intervention can improve weight loss over existing best practices.

This 4-month randomized controlled trial is designed to investigate the short-term efficacy and feasibility of a novel, social support-enhanced behavioral weight control intervention. Participants will be recruited via email listservs, fliers, and word of mouth. They will be randomized to a standard behavioral weight control treatment (SBT) or a social support-enhanced behavioral weight control treatment which receives the same intervention as SBT plus social support resources (specifically, additional self-monitoring technologies) for weight loss.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 25 kg/m2 and 55 kg/m2
* Age 18 years or older
* Access to a computer with an Internet connection
* Smartphone ownership (Android or iOS)
* Willing to be randomized to either one of the two study groups
* Only one member of the same household eligible to participate

Exclusion Criteria:

* Currently lactating, pregnant, or planning to become pregnant during the length of the study
* Been diagnosed with type 1 or type 2 diabetes
* Medical or physical contraindications or limitations for engaging in physical activity
* History of major medical or psychiatric conditions
* Recent changes in medication known to affect weight
* Schedule that would prohibit or restrict attendance at a designated time for weekly in- person group meetings
* Currently participating in a weight management program
* Currently on medication that might affect weight loss
Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients

Participants will randomly be placed into one of four groups and experience one of the four following conditions: (1) a placebo light that provides a 40 hertz (Hz) flicker (rhythmic light \[RL\]); (2) a placebo light with a random flicker (placebo condition for rhythmic light); (3) a light source that will stimulate the circadian system and provides a 40 Hz flicker (RL); or (4) a light source that will stimulate the circadian system and provides a random flicker (placebo condition for rhythmic light). Following a baseline week, participants will experience his/her assigned lighting condition for two hours in the morning for 8 weeks. After a 4-week washout period, a final round of assessments will be obtained. Study assessments (except for the Pittsburgh Sleep Quality Index and Montreal Cognitive Assessment) will be collected at the end of each week, for a total of 8 assessments.

The tailored lighting intervention used to promote circadian entrainment will provide high circadian stimulation during the day produced by narrowband blue light peaking at 470 nanometers (nm). A comparison lighting intervention (i.e., placebo lighting), a narrowband red light peaking at 630 nm, will be used as a control. Both the red and the blue light devices will also provide either the 40 hertz (Hz) flicker (RL) or the random flicker (placebo RL). For the random flicker (placebo RL), the duty cycle will be delivered with a random interval determined by a Poisson process with an average interval of 40 hertz (Hz).

Eligibility Criteria:
Inclusion Criteria:

* Participants must be diagnosed with mild cognitive impairment or mild Alzheimer's disease, as defined by a Montreal Cognitive Assessment score between 17 and 25;
* Have sleep disturbance indicated by a score \>5 on the Pittsburgh Sleep Quality Index
* Participants must reside in their homes, independent living, or assisted living facilities

Exclusion Criteria:

* Participants taking sleep medication
* Residence in a skilled nursing facility or long-term care
* Obstructing cataracts, macular degeneration, and blindness
* Severe sleep apnea or restless leg syndrome
* History of severe epilepsy
Sequencing in Inflammatory Bowel Diseases (IBD) Therapy: "the Latium Net".

Patients with IBD, both UC and CD, who fulfil the inclusion and exclusion criteria will be included consecutively:

* Retrospective cohort Patients treated with IBD from January 2015 to June 2024 will be included.
* Prospective cohort Consecutive patients with IBD who are starting, from clinical practice, new biological/small molecule therapies, failure (already exposed) to a mechanism of action (for anti TNF-alpha, more than one molecule is allowed), and who belong to the Lazio Regional Health System.

Eligible subjects will be identified among patients belonging to the IBD Unit of the Digestive Diseases Centre (CEMAD) of the Foundation and to all the other IBD Units of all the centres specified in Annex 1. Based on the number of patients referred to the clinics, we estimate 112 patients per month, the time for recruitment is 24 months.

Potential study participants will receive oral and written information about the study. Patients who agree to participate in the study will be asked to sign a written informed consent according to GCP.

Multicenter, ambispectic observational study with drug

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 70 years
2. Patients with a previous diagnosis of CD or UC at least 3 months before baseline.
3. Patients who have already failed at least one advanced (biological or small molecule) therapy for IBD and who have experienced failure to at least one mechanism of action (failure is defined as primary failure, secondary failure, or intolerance).
4. Patients who have already started a new advanced therapy for IBD based on clinical practice indication (primary loss of response, secondary loss of response, intolerance to the previous drug) since at least 1 week and up to 8 weeks after starting it.
5. Written informed consent certifying the willingness of the subject to participate to the study.

Exclusion Criteria:

1. Age \< 18 years.
2. Patients with diagnosis of indeterminate colitis.
3. Patients naive to advanced (biological or small molecule) therapy for IBD.
4. Refusal to sign written informed consent certifying the willingness of the subject to participate to the study.