cyrilzakka/clinical-trials huggingface dataset:
Embedded Narrative in Interactive Game Design for Improving Medication Adherence of Schizophrenia

This study explores the potential of an interactive narrative game to enhance medication adherence among stable schizophrenia patients. Employing participatory design methods, game's development and testing process actively involved patients and individuals closely connected to their daily lives. Artificial Intelligence-Generated Content (AIGC) facilitated swift iterations in game's visual style and content. During game therapy, patients are tasked with making decisions based on presented situations, which influence the course of the narrative.

Our game design is inspired by Cognitive Behavioral Therapy (CBT), specifically the autonomic engagement and emotion regulation for the treatment of stable schizophrenic patients. This design aims to motivate patients to practice the basic principles of CBT in a virtual environment with the aim of producing positive psychological and behavioral changes in real life.

To ensure that the interactive design in the game can effectively promote cognitive reconstruction and emotional regulation in patients, the investigators used the following game interaction strategies:

1. Situational simulation: By simulating real-life situations, patients face challenges and make decisions in the game that are similar to those in real life, so as to train their cognitive and emotional regulation.
2. Immediate feedback: Provide patients with immediate feedback during the game so that they can understand the impact of their decisions on the outcome of the game, thus encouraging them to make more positive decisions in real life.
3. Role-imitation: Encourage patients to take an in-depth look at their thoughts and behaviors from a third-person perspective by having them take on the role of a therapy practitioner.

Eligibility Criteria:
Inclusion Criteria:

* Stable Phase Schizophrenia
* on long-term medication
* medication adherence was problematic

Exclusion Criteria:

* Serious Schizophrenia
* Lack of basic cognitive abilities
PK Comparisons of Bepotastine Besilate 10 mg and Bepotastine Salicylate 9.64 mg

To compare the relative bioavailability and pharmacokinetic characteristics of a newly developed bepotastine formulation, bepotastine salicylate, with a conventional formulation, bepotastine besilate, in healthy subjects with a single dose, randomized, open-label, 2-sequence -2period crossover study.


Eligibility Criteria:
Inclusion Criteria:

* subjects aged between 20 and 45 years
* Body weight \> 50 kg (in case of female \> 45 kg) with BMI between 18 and 29 kg/m2
* Signed and dated informed consent form which meets all criteria of current FDA and KFDA regulations

Exclusion Criteria:

* subjects with acute conditions.
* presence of history affecting ADME
* Clinically significant history or current evidence of a hepatic, renal, gastrointestinal, or hematologic abnormality
* Hepatitis B, hepatitis C, or HIV infection revealed on the laboratory findings
* Any other acute or chronic disease
* A history of hypersensitivity to bepotastine
* A history of alcohol or drug abuse
* Participation in another clinical trial within 2 months
* smoked \>10 cigarettes daily
* consumption over 5 glasses daily of beverages containing xanthine derivatives
* use of any medication having the potential to affect the study results within 10 days before the start of the study.
* medication of the inhibitors or inducers of DME including barbiturates within 1 month
* one of abnormal lab findings as like

  * c. AST/ALT \> UNL (upper normal limit) x 1.5
  * Total bilirubin \> UNL x 1.5
Investigating the Relationship Between Parents and Their Children With ADHD and Conduct Disorder

This study aims to uncover mechanisms of action underlying any long-term change in youth antisocial behavior by considering the role of child and family characteristics as mediators and moderators of change. The study design is qualitative interviews to be conducted face-to-face with parents of children previously diagnosed with Conduct Disorder and Attention Deficit Hyperactivity Disorder (ADHD) but no longer meet diagnostic criteria. Questions will be asked to understand participants' parenting experience over time (before, during and after their children's treatment).


Eligibility Criteria:
Inclusion Criteria:

* Parents of children who participated in previous study "Supplements and Social Skills Intervention" conducted by Singapore Institute of Mental Health Child Guidance Clinic.
* Children no longer meet the criteria for Conduct Disorder and ADHD, as measured by Antisocial Process Screening Device (APSD) Callous-Unemotional score of 7 or less, and who do not meet the cut-off for rule-breaking and aggressive behavior determined by Child Behavior Checklist (CBCL). These data were collected from a previous study.

Exclusion Criteria:

* Children who still meet the requirements of Conduct Disorder and ADHD as defined above.
* Parents who did not indicate that they wish to be contacted for follow-up studies.
AKI Prevention and Early Intervention in VAD Patients Admitted for Acute Medical Events.

The investigators are doing this research to investigate whether multifaceted preventive measures for newly hospitalized ventricular assist device (VAD) patients will reduce the Acute Kidney Injury (AKI) occurrence rate, progression and associated complications

The purpose of the study is to investigate whether preventive measures for newly hospitalized ventricular assist device (VAD) patients will reduce the Acute Kidney Injury (AKI) occurrence rate, progression and associated complications

Participants will be in the study for the first 7 days of hospitalization. The study investigators will access the electronic medical record daily from admission day 1 through admission day 7 in order to provide clinical recommendations in an effort to minimize AKI risk as per routine practice.

If the patient is discharged prior to day 7 the study, intervention will be terminated on day of discharge.

The investigators will review the participant's medical record up to one year after surgery.

This study will not include any experimental laboratory tests or experimental medication.

The clinical recommendations will regard the following:

1. Avoidance of potentially nephrotoxic medications (e.g. NSAIDs, intravascular contrast, nephrotoxic antimicrobials)
2. Optimizing volume status (avoidance of volume overload or depletion)
3. Optimizing electrolytes and acid-base status
4. Optimizing hemodynamics (Mean arterial BP\>65mmHg)
5. Assessment of kidney function with serum creatinine and/or cystatin C None of the suggestions will be experimental. All suggestions will be based on standard nephrology practice.

The investigators plan to compare the results of the current study with those in in the years of 2012-2017 (1/7/2012- 1/7/2017) via retrospective chart review

Eligibility Criteria:
Inclusion criteria:

Adult patients with VAD in place who are admitted to the hospital for acute medical illness during the study period. For those with multiple admissions during the study period only the first admission will be studied.

Patients who are able to give consent. In case of patients that are mentally impaired we will obtain consent from power of attorney and when patients regain intact mental capacity we will reobtain consent from the patient.

Exclusion criteria:

Patients on dialysis (hemodialysis or peritoneal dialysis).
Ultrasound Guided Ganglion Impar Block

The aim of this study is to evaluate feasibility, reliability and short term effectiveness of ganglion impar block with ultrasound in patients with chronic coccygodinia.

Ganglion impar blocks have long been used for coccydynia, either with a landmark-based technique or fluoroscopic guidance. With the growing use of ultrasound, ultrasound-guided ganglion impar block has become a viable alternative.

Despite its frequent use in clinical practice, ultrasound has limitations in visualizing structures behind the bone, while fluoroscopy remains the gold standard. Further research is needed to evaluate its feasibility, safety, and efficacy.

This study primarily aims to assess the feasibility and safety of ultrasound-guided ganglion impar block in coccydynia. Additionally, it will examine its short-term (1-month) efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-65 years.
* Coccydynia persisting for at least three months.
* Being scheduled for a ganglion impar block in the pain medicine outpatient clinic.
* Having inadequate response to medical and conservative treatments.
* Aggreeing to undergo the interventional procedure and participate in the study.

Exclusion Criteria:

* Local infection at the injection site.
* Bleeding disorders or diseases and drugs that may cause bleeding diatesis (e.g. renal failure, liver failure, anticoagulant treatments)
* History of allergic reaction to the medications to be used.
* Pregnancy
LLLT and Russian Electrical Stimulation in Osteoarthritis

Objectives: To investigate the effect of low-level laser therapy (LLLT) application combined with Russian Electrical Stimulation on pain, mobility, functionality, range of motion, muscular strength, and activity in patients with osteoarthritis of the knee.

Design: Randomized controlled double-blind study. Setting: Specialist Rehabilitation Services.

ABSTRACT Objectives: To investigate the effect of low-level laser therapy (LLLT) application combined with Russian Electrical Stimulation on pain, mobility, functionality, range of motion, muscular strength, and activity in patients with osteoarthritis of the knee.

Design: Randomized controlled double-blind study. Setting: Specialist Rehabilitation Services. Participants: Eighty participants with knee osteoarthritis were randomized. Intervention: Participants were randomized into four groups: Group I (n=20; LLLT over three weeks followed by an eight-week receiving Russian electrical stimulation), Group II (n=20; Placebo laser over three weeks followed by an eight-week receiving Russian electrical stimulation), Group III (n=20; LLLT over three weeks followed by an eight-week receiving LLLT application combined with Russian electrical stimulation), Group IV (n=20; Placebo laser over three weeks followed by an eight-week receiving Placebo laser application combined with Russian electrical stimulation). The groups treated with LLLT received treatments with invisible infrared laser (904 nm, 3 Joules/point). The Placebo groups received identical treatment, but the infrared laser output was disabled. The sessions occurred three times a week.

Main outcome measures: The primary outcome was the change in knee pain and functionality (Lequesne). Secondary outcomes included change in mobility (8 meters and Timed Up and Go test), range of motion (goniometer), muscular strength (dynamometer), activity (Western Ontario and McMaster Universities Osteoarthritis questionnaire) and medication intake.

Eligibility Criteria:
Inclusion Criteria:

1. levels 2-4 according to Kellgren-Lawrence grade
2. aged 50-75 years
3. both genders
4. have knee pain and functional disability for at least three months
5. according to the criteria of the American College for Rheumatology.

Exclusion Criteria:

* cancer, diabetes, symptomatic hip osteoarthritis, or used antidepressants, anti-inflammatory medications or anxiolytics during six months prior to enrolment.
Focal Muscle Vibrations in Acute Stroke

A prospective, randomized, double-blind, sham-controlled trial designed to evaluate the effects of Repeated Muscle Vibration (rMV) on motor recovery in acute stroke patients treated within 72 hours of symptom onset

After enrollment (T0), patients are randomly assigned to either the vibration group (VG) or the control group (CG). Patients in the VG will receive rMV treatment, while those in the CG receive sham treatment. Both interventions are administered on the 1st, 2nd, and 3rd days post-enrollment. Physiokinesitherapy (PT) and occupational therapy (OT) are provided daily to all patients, starting immediately after the T0 clinical evaluation. Patients are re-evaluated after 4 ± 1 days (T-1), marking the end of the treatment period.

Upon admission, demographic details and medical histories of all participants are recorded. Each patient undergoes clinical evaluations at all time points by an experienced investigator blinded to group allocation and distinct from the recruiting personnel. The clinical assessment includes stroke severity evaluation using the NIH Stroke Scale, motor and functional limb abilities using the Fugl-Meyer scale, SAFE score, and Motricity Index. Additionally, bioimpedance analysis of muscle mass and phase angle in the impaired upper limb is performed using the BWA device.

All participants follow a standardized daily rehabilitation program. Physical therapists, blinded to treatment allocation, are instructed on the duration, frequency, and content of therapy to ensure consistency across groups.

Low-amplitude rMV (frequency: 100 Hz; amplitude: 1-2 mm) is applied to the flexor carpi radialis and biceps brachii for upper limb treatment, using a commercial device (VibraMoov Physio, TechnoConcept, Mane, France). The rMV sessions are conducted over three consecutive days by two trained physiotherapists, with each daily session comprising three 10-minute treatments (per treated limb) interspersed with 1-minute breaks.

During the rMV sessions, participants are instructed to perform voluntary isometric contractions of the treated muscle. In contrast, CG participants undergo sham rMV, where the vibrator is positioned near the tendon but without vibration.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntary patients in the acute phase of a sylvian ischemic stroke (from day 1 to day 7 post-stroke)
2. Estimated hospital stay expected to exceed 7 days
3. Age ≥ 18 years
4. Able to understand and follow evaluation instructions
5. Provided informed consent
6. Affiliated with a social security scheme
7. SAFE score between 4 and 7 on the affected side

Exclusion Criteria:

1. Individuals under guardianship or curatorship
2. Individuals deprived of liberty
3. Individuals under legal protection (safeguard of justice)
4. Other neurological or rheumatological conditions limiting mobility
5. Drowsiness (related to stroke or medication)
6. Pregnant or breastfeeding women
Major Bleeding Risk Associated With Antithrombotics

Prospective, multicenter, observational study with a three-year inclusion period (from January 1, 2012 to December 31, 2015) and a 6-month follow-up

All adults subjects living in the five well-defined areas affiliated to the French National Health Insurance System and having had at least one reimbursement of any antithrombotic in the 3-year study period are identified by using data from the National Health reimbursement database (Système National d'Information Inter-Régimes de l'Assurance Maladie, SNIIR-AM). SNIIR-AM contains individualized, anonymous and comprehensive data for all health spending reimbursements of affiliated subjects, including basic patient demographic data, medical drugs as well as outpatient medical care, prescribed or performed by health-care professionals from both public and private practices. This allows to calculate a denominator (number of person-years of anti-thrombotic drug exposure).

Crude incidence rates of major bleeding per 100 person-months are calculated in antithrombotic users, anticoagulants and others; stratification on a modified HAS-BLED score allows fair comparison between anti-thrombotic drug classes.

Eligibility Criteria:
Inclusion Criteria:

* Patient with major bleeding event associated with antithrombotic drug
* Patient older than 18 years old
* Information on 1 and 6-month follow-up is given pending non-opposition letter

Exclusion Criteria:

* Patients with major bleeding events associated with antithrombotic during hospitalization
* Patients with intentional overdose with antithrombotic drugs
* Patients with multi-trauma
* Patients living outside the defined influence areas of the five participating cities
Information and Accompaniment of Siblings Following the Announcement of a Cancer in Pediatric Hematology.

The primary objective is to evaluate the experience with the information received on the disease by the healthy brothers and sisters of childrens with malignant haemopathy at the Centre Hospitalier Régional et Universitaire of Lille


Eligibility Criteria:
Inclusion Criteria:

* Children from 6 to 12 years old
* Brother or sister of a child:

O has malignant haemopathy O follow-up in the pediatric hematology department in Lille, O diagnosed from 6 weeks to 1 year before maintenance of the healthy subject included

* whose parents are able to understand and sign voluntarily informed consent
* Affiliated to a social security scheme
* Ability to understand and answer questions alone during the semi-structured interview

Exclusion Criteria:

* Child under 6 years or over 12 years
* Subject with a pathology that may interfere with the course of the study, according to the investigator's assessment
* Absence of the informed consent of one of the parents and / or the legal representative
* Refusal of participation of the subject
Efficacy of Buprenorphine on Postoperative Endodontic Analgesia

To see whether the addition of buprenorphone to local anesthesia will lengthen postoperative analgesia for endodontic pain


Eligibility Criteria:
Inclusion Criteria:

* persons with preoperative pain to percussion of a tooth with pulpal disease requiring endodontic therapy, healthy individuals, ASA Class I and II, no known allergies to the drugs being administered

Exclusion Criteria:

* pregnancy, allergy to buprenorphine, allergy to local anesthetic
Impacts of Stoppa and Total Extraperitoneal Inguinal Hernia Repair on the Lower Extremity Muscular Functions

Comparison of physical activity parameters of the lower extremity muscles in patients who received total extraperitoneal repair (TEP) and STOPPA repair.

The patients were evaluated during the preoperative period and in the postoperative day 3, to achieve an isometric and isokinetic, objective assessment of the pain-related lower extremity muscular function changes.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral inguinal hernia

Exclusion Criteria:

* Contralateral hernia repair history
* Recurrent inguinal hernia
* Incarceration or strangulation
* Bilateral inguinal hernia
* Severe congestive heart failure
* Severe hypertension
* Rheumatoid arthritis
* Systemic or neurologic diseases altering lower extremity functions
Development of Brief Positive Affect Treatment (PAT) for Caregivers of Patients with Advanced Cancer

To learn more about the experience and wellbeing of people who provide care for cancer patients.

OBJECTIVES

Primary Objectives:

The primary objective of this proposal is to identify relevant themes and content essential to adapt PAT to a caregiving in advanced cancer context (PAT-C) and develop a Brief (5-session) version of PAT-C. Findings from this study are essential to inform future RCTs to test the feasibility, efficacy, dose and explore potential mediators of treatment outcomes of this intervention.

Secondary Objectives:

The secondary objective is to characterize psychosocial distress and psychosocial health of caregivers in the supportive care clinic. This data will be essential to inform appropriateness of the supportive care clinic as a potential site for future RCTs (i.e., determine if there are enough caregivers in this clinic who might benefit from this specific supportive care strategy).

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Males and female adults ≥18 years
* Able to read and speak English
* Caregiver of a patient diagnosed with stage IV solid malignancy, with whom they have been residing for \>6 months
* Access to necessary resources for participating in a technology-based intervention (i.e., telephone, internet access)

Exclusion Criteria:

* Current participation in consistent (self-defined) psychotherapy
* Caregivers who are considered part of a vulnerable population (i.e. cognitively impaired (self-reported or patient-reported), pregnant, military personnel) will not be eligible.
Chickpea Pulao Using Fenugreek Seeds and Indian Rennet for Improving Blood Glycaemic Levels

The goal of this study was to perform a clinical trial to compare the impact of herbal chickpea pulao (cooked Indian-Pakistani rice dish) on improving postprandial blood glucose levels in type-2 diabetic people. The main questions it aims to answer are:

* Whether Indian rennet and fenugreek seed extract can modulate blood sugar levels or not?
* At what concentration the flavor, taste, and blood sugar impact were acceptable?

Participants were provided with control and intervention herbal chickpea pulao for a period of 21 days and asked to provide feedback on taste, flavor, and over-acceptability, and their postprandial blood glucose levels were checked.


Eligibility Criteria:
Inclusion Criteria:

* People having Type-2 diabetes disease
* Must be able to consume chickpea rice pulao
* Must not be on vegan or keto diet

Exclusion Criteria:

* Healthy people without diabetes
* People with less than 18 years of age
Senescent Endometrial Cells in Patients with Thin Endometrial Lining

The goal of this observational study is to determine if thin endometrial lining that is unresponsive to estrogen might be associated with the presence of senescent cells in patients following long-term use of oral contraceptives. The main question it aims to answer is:

Are there any senescent cells present in thin endometrial lining?

During the luteal phase of the cycle, participants will will undergo:

* Gynecologic US to measure the endometrial lining thickness and pattern.
* Endometrial biopsy with Pipelle catheter

The investigators hypothesized that senescent cells in the endometrium may be the cause of the failure of thin endometrium to respond to normal growth stimuli such as estrogen.

The outcome that research team anticipate to measure is the percentage of senescent cells in the endometrial biopsies of women with thin endometrium compared to the control group biopsies.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-39
* BMI - up to 35
* Thin endometrium after OCP use
* Asherman's syndrome
* Women already undergoing endometrial biopsy for infertility testing (eg. EMMA testing)
* Women with archived endometrial biopsy samples

Exclusion Criteria:

* Women with systemic disease (Rheumatic disease, DM)
* Women with coagulopathies
* Women with active pelvic inflammatory process
* Uterine anomalies
* Pregnant women
* Any hormonal contraception use or IUD