cyrilzakka/clinical-trials huggingface dataset:
Pilot Study of Cardiac MR in Patients With Muscular Dystrophy

Muscular Dystrophy can affect the skeletal muscles and also the heart and breathing muscles, causing significant morbidity and mortality. As patients are now living longer, treatment of muscular dystrophies involves drugs that help improve heart function. However, better types of heart imaging studies are needed to understand how these treatments work. Researchers want to improve heart imaging to identify earlier indicators of heart dysfunction in muscular dystrophy patients and how these are changed by medical treatment. The new imaging indicators will also help identify candidates for entry into future clinical trials.

Cardiomyopathy causes significant morbidity and mortality in multiple forms of muscular dystrophy affecting children, including Duchenne muscular dystrophy (DMD), Becker muscular dystrophy (BMD) and subtypes of autosomal recessive limb-girdle muscular dystrophy (LGMD2). Pharmaceutical treatments for the cardiomyopathy of muscular dystrophy, including angiotensin-converting enzyme (ACE) inhibition and beta-adrenergic receptor blockade, afford significant benefit and demonstrate cardiac remodeling in clinical studies. Further studies are needed to identify and characterize more sensitive indicators of cardiac dysfunction in muscular dystrophy subjects to better stratify subjects for entry into clinical protocols.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Duchenne, Becker, or Limb Girdle Muscular Dystrophy

Exclusion Criteria:

* Day-time users of continuous positive airway pressure (CPAP)
* Sip ventilator users
* Invasive ventilator dependent
* Pregnant minors or adults (when uncertain, participants will undergo urine testing) or lactating minors and adults
* Females who are nursing and who do not plan to discard breast milk for 24 hours
* Decompensated congestive heart failure (unable to lie flat during CMR)
* Impaired renal excretory function (calculated Glomerular Filtration Rate less than 30 milliliters/min)
* Contra-indications to Magnetic Resonance Imaging:
* Cardiac pacemaker or implantable defibrillator
* Cerebral aneurysm clip
* Neural stimulator
* Metallic ocular foreign body
* Any implanted device (i.e. insulin pump, drug infusion device)
* Claustrophobia
* Metal shrapnel or bullet
* Investigator assessment of inability to comply with protocol
* Unable/unwilling to lie still throughout the research procedure or who require sedation
* Persons with cognitive impairment
Affirmative Mindfulness, Acceptance, and Compassion-based Intervention for SM

The goal of this pilot clinical trial is to explore the effectiveness of Free2Be group intervention for sexual minorities. The main questions it aims to answer are:

* Is it Free2Be effective in the decrease of stress?
* Are mindfulness, acceptance, and self-compassion responsible for changes in psychological symptoms?

Participants will receive an affirmative mindfulness, acceptance, and self-compassion-based face-to-face group intervention with 13 weekly sessions (Free2Be).

Sexual Minorized (SM) individuals include several self-identified nonheterosexual sexual orientations. This population face uncountable forms of discrimination stemming from social stigma. Unsurprisingly, levels of psychopathology are poorer in SM individuals when compared to heterosexual individuals, The Minority Stress Model describes stress processes that help to explain this disparity, for example, expectations of rejection and internalized stigma. Beyond the specific minority-related processes, general maladaptive psychological processes also contribute to the elevated risk of psychopathology in this population (Psychological Mediation Framework), for example, self-criticism. Additionally, shame and fears of compassion seem to affect the mental health in this population.

When SM individuals try to access mental health care, they find inappropriate and discriminatory services with professionals without specific training on sexuality-related themes. Affirmative interventions are wide approaches with a positive and respectful perspective about sexual orientations, recognizing different identities as representations of human diversity. This approach identifies negative consequences in mental health as consequences of stress related to heterosexism, discrimination and violence against SM individuals.

Previous studies reinforcing the relevance of mindfulness, acceptance, and self-compassion as positive psychological processes for SM individuals. Free2Be was the first affirmative intervention based on mindfulness, acceptance, and compassion techniques for SM individuals, and is a manualized 13 weeks, face-to-face group intervention. The feasibility results highlighted the acceptability of this intervention, suggested some changes in the intervention content, and concluded about the viability of a pilot study.

Eligibility Criteria:
Inclusion Criteria:

* Majority (\> 18 years old)
* Nonheterosexual self-identified
* Being Portuguese
* Perfectly understanding of Portuguese oral and written language
* Gave informed and free consent

Exclusion Criteria:

* Currently receiving individual or group psychotherapy
* Major Depressive Disorder - severe specifier
* Hypo/maniac Episode - without full remission
* Psychosis Characteristics in the last two months
* Social impairment from Substance Use Disorder
* High suicide risk (according to the Suicide Risk Index).
Pain, Acceptance, and Discomfort With Periodontally Accelerated Osteogenic Orthodontics (PAOO)

Patients will be examined in the Orthodontic Department of the University of Damascus Dental School. Patients who will be treated in conjunction with the PAOO procedure and subjects who will meet the inclusion criteria will be included then the initial diagnostic records (diagnostic gypsum models, internal and external oral photographs, as well as radiographic images) will be studied to ensure that the selection criteria will be accurately matched. This study aims to assess patients' acceptance of the PAOO procedure as well as the levels of pain and discomfort associated with this treatment.

Surgical procedure associated with PAOO The surgery will be performed under local anesthesia and then full-thickness flaps will be reflected labially only from the distal surface of the lower right canine to the distal surface of the lower left canine, after washing the exposed alveolar bone with saline, then a selective cortical cutting will be performed using a piezosurgery and then the Bone-D® xenograft (particle size of 0.2 mm-1.0 mm) from Medpark (Busan, Korea) will be placed, then the wound will be sutured. Then a schedule will be set up to review the patient after 1, 7, 14, and 28 days to fill out questionnaires related to pain, acceptance, discomfort, satisfaction, and follow-up to orthodontic treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Class I malocclusion with moderate crowding (4-6 mm of a tooth-size-arch-length-discrepancy).
2. Good oral hygiene and periodontal health.
3. No severe skeletal discrepancy.
4. Normal proclination for the upper and lower incisors.
5. No congenitally missing or extracted teeth (except for the third molars).

Exclusion Criteria:

1. Bimaxillary dentoalveolar severe protrusion.
2. Previous orthodontic treatment.
3. Subject with psychological abnormalities.
4. Subject with systemic diseases.
Efficacy of Combining an Inferior Alveolar Nerve Block With a Buccal Infiltration

OBJECTIVE To compare the effectiveness of using both a combined technique of an Inferior Alveolar Nerve block and buccal infiltration with that achieved by utilizing an Inferior Alveolar Nerve block alone for endodontic treatment of mandibular molars with irreversible pulpitis.

STUDY DESIGN Randomized clinical trial PLACE AND DURATION OF STUDY Operative Dentistry Department of Armed Forces Institute of Dentistry Rawalpindi, from 1st April 2020 to 31st September 2020.

MATERIAL AND METHODS A total of 120 patients were enrolled in the study. Sixty patients of group A received conventional Inferior Alveolar Nerve block and sixty patients of Group B received buccal infiltration along with conventional Inferior Alveolar Nerve block.

Patients of Group A received Inferior Alveolar Nerve block anesthesia. For this block, nerve was approached from the contra-lateral side of the oral cavity over the contralateral premolars. Needle penetrated into the mandibular tissue on the average boundary of the mandibular ramus inside the pterygomandibular space and lateral to pterygomandibular fold, it advanced until bony surface was contacted. In the event that bony contact wasn't made inside 27-29 mm of needle infiltration, needle was pulled back somewhat, moved the needle further distally toward premolars. The needle was withdrew 1-2 mm after making bony contact, aspiration was performed, followed by 1.8 ml deposition of anesthetic solution.

Patients of Group B received buccal infiltration as supplementary injection technique to conventional Inferior Alveolar Nerve block, buccal infiltration was carried out. The needle was penetrated in buccal mucosa adjacent to mandibular 1st molar. After aspiration, 1.8ml of anesthetic solution was dumped in approximate time of 2 minutes using 2% lignocaine with 1:100,000 epinephrine. Following time period of 15 minutes of injection, every patient was inquired about his/her lip numbness. Patients who did not experience significant lip numbness within 15 minutes after the block was administered were excluded from the investigation and was considered ineffective. In case of positive lip numbness patient concerned teeth was isolated using rubber dam and a traditional access opening was started. Patient was told to lift hand if any pain will occur while doing procedure. The patient was requested to mark pain on visual analogue scale (VAS) after completion of treatment. Absence of pain was indicated if patient scored his/her pain ≤ 3 on VAS.

Eligibility Criteria:
Inclusion Criteria:

* Mandibular molars with irreversible pulpitis (confirmed by positive response to EPT)
* Patient age between 18 to 45 years
* No medication taken 24 hours before treatment
* Both male and female patients

Exclusion Criteria:

* Patients on analgesics or anti-inflammatory drugs
* Medically compromised patients
* Teeth with immature apices
* Retreatment cases
* Patients allergic to lignocaine
* Teeth with root resorption
* Teeth with necrotic pulp
* Apical abscess
* Pregnancy
A Comparison of Stroke Volume Variation for Prediction of Fluid Responsiveness

Stroke volume variation (SVV) is an indicator used to assess the patient's volume status. The FloTrac system (Edwards Lifesciences, Irvine, CA) continuously monitors cardiac output (CO) and SVV (SVV-FloTrac) by analyzing the systemic arterial pressure wave. Numerous studies have demonstrated that SVV-FloTrac serves as a reliable indicator of fluid responsiveness. However, its peripheral invasiveness raises concerns about susceptibility to reflecting waves, damping, and vascular tone influences.In contrast, Transthoracic electrical bioimpedance (BioZ.com™) offers a non-invasive approach for continuously monitoring various hemodynamic variables. In this study, the primary aim was to assess the agreement between simultaneously measured SVV-FloTrac and SVV-BioZ.


Eligibility Criteria:
Inclusion Criteria:

* Age 18≤ Age ≤65
* patients undergoinglaparoscopic elective surgery for gastrointestinal tumors under general anesthesia
* 18 kg/m2≤BMI≤30 kg/m2
* ASA classification I-III
* Patients signed informed consent form

Exclusion Criteria:

* Arrhythmias
* The patient is diagnosed with severe cardiovascular disease（pulmonary arterial hypertension、left ventricular ejection fraction\< 50%、aortic aneurysm、extensive peripheral arterial occlusive disease,、significant valvulopathy）
* Severe heart failure (METS\<4)
* The patient is diagnosed with severe hepatic dysfunction (ChildePugh class C)
* The patient is diagnosed with severe renal dysfunction (undergoing dialysis before surgery)
* There is an infectious lesion on the skin or subcutaneous tissue where the non-invasive electrode piece is placed
* History of allergy to anesthetic drugs
* Weight\<40kg
* Allergies to 6% hydroxyethyl starch, Fresenius Kabi, Deutschland
Adult Study / OROS Methylphenidate Hydrochloride (HCL) (OROS MPH) in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

The purpose of this study is to compare the ADHD symptom response of adults with ADHD treated with OROS MPH to those treated with placebo.

The hypothesis is that Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCL (OROS MPH) is safe and effective in improving Attention Deficit Hyperactivity Disorder (ADHD) symptoms in adults with ADHD when compared to placebo as demonstrated using specific study measures. This is a double-blind (neither participant nor investigator knows the name of the assigned study drug), randomized (study drug assigned by chance), placebo-controlled study to evaluate the efficacy and safety of OROS MPH using the optimal dose for each adult patient in the study with ADHD. The primary efficacy variable in this study is the change from baseline to final evaluation using the Adult ADHD Investigator Symptom Rating Scale (AISRS) to measure patient ADHD symptoms. Participants will also be assessed for adverse events throughout the study. Patients will initiate treatment with oral OROS MPH 18 mg or matching placebo at baseline and continue morning dosing with increases every week until an optimal dose is achieved, up to the maximum of 72 mg/day of OROS MPH or matching placebo. Eligible patients will remain in the study for a maximum of 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* ADHD diagnosis (any type: Combined, Predominantly Inattentive, or Predominantly Hyperactive-Impulsive)
* Patients with an Adult ADHD Investigator Symptom Rating Scale (AISRS) score greater than 24 at screening/baseline
* Ability to read and understand English

Exclusion Criteria:

* Any significant history of cardiovascular disease or cardiovascular disease detectable via ECG
* History of diagnosis of substance or alcohol dependence or admission/hospitalization for rehabilitation for dependence
* Current neurologic or psychiatric diagnosis that would make patient inappropriate for participation
* Anxiety assessments of moderate or severe
* Depression assessments of moderate or severe
* History or current suicidal thoughts or attempts
* Known allergies, hypersensitivity, or intolerance to OROS MPH
Obstructive Sleep Apnea and Telomere Length

Obstructive sleep apnea (OSA) is a highly prevalent and morbid sleep disorder. Among the factors associated with its pathophysiology, the role of intermittent hypoxia stands out, contributing to the development of oxidative stress and inflammation. It is known that cumulative levels of these factors negatively influence the final portion of the DNA, known as telomere. In this sense, the investigators hypothesize that OSA is capable of accelerating aging process through telomere shortening mediated by inflammatory and oxidative markers. Thus, the aim of this study is to investigate the effect of OSA and its treatment with CPAP on the variation of telomere length and their associated mechanisms. For this, a randomized, double-blind, sham-controlled clinical study with 6 months duration will be conducted. We will recruit male participants with OSA diagnosis (apnea-hypopnea indexe15/hour), aged between 35-65 years and body mass index\<35 kg/m2, which will be randomized to use CPAP or sham-CPAP for 6 months. Participants will visit the laboratory 7 times (baseline and after 1, 2, 3, 4, 5 and 6 months) and will be submitted to clinical and otorhinolaryngological evaluation, sleep questionnaires, polysomnography and blood collection for DNA and extraction and measurement of telomere length, as well as the expression of telomerase and oxidative and inflammatory markers (ADMA, homocysteine, cysteine, TBARS, 8-oxodG, TNF-a, IL-6 and IL-10). This project aims to contribute to the elucidation of the effect of OSA on telomere length maintenance, as well as the adjacent mechanisms to this relationship.


Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) of less than 35kg/m2
* age between 35 and 65 years
* diagnosed by laboratory polysomnography with moderate to severe OSA (apnea-hypopnea index, AHI≥20 events/hour of sleep)

Exclusion Criteria:

* illiteracy
* participants with more than 50% of the respiratory events obtained in the polysomnography exam being central apneas
* participants with central AHI\>5 events/hour of sleep
* participants with sleepiness, measured by the Epworth sleepiness scale≥14
* participants with severe otorhinolaryngological diseases that preclude the use of CPAP (severe nasal septum deviation, severe nasal turbinate hypertrophy, marked palatine and/or adenoid hypertrophy)
* abuse of alcohol or chronic use of psychoactive drugs
* participants with decompensated clinical, neurological or psychiatric illness
* participants with other sleep disorders; participants who had already undergone previous OSA treatments
The Effectiveness and Safety of Vagus Nerve Stimulation for TRE

Prospective cohort studies to identify clinical epilepsy control, cognitive changes, and safety of VNS in patients with tuberous sclerosis complex-related epilepsy.

This study aims to evaluate the efficacy and safety of vagus nerve stimulation (VNS) in the treatment of drug-resistant epilepsy in patients with Tuberous Sclerosis Complex (TSC) and compare it with traditional antiepileptic drug therapy. By assessing seizure frequency, severity, and improvements in quality of life, the study seeks to provide evidence-based guidance for clinical treatment strategies.

Eligibility Criteria:
Inclusion Criteria:

* Age Range: Patients aged 1 to 18 years.
* Confirmed Diagnosis: Diagnosed with Tuberous Sclerosis Complex (TSC) according to established diagnostic criteria.
* Drug-Resistant Epilepsy: Ineffectiveness of at least two antiepileptic drugs (monotherapy or combination therapy).
* Informed Consent: Patients and their guardians understand the purpose of the study and voluntarily sign the informed consent form.

Exclusion Criteria：

* Other Severe Diseases: Presence of significant cardiovascular, respiratory, or other systemic diseases.
* Psychiatric Disorders: History or presence of severe psychiatric disorders (e.g., schizophrenia or major depressive disorder).
* Surgical Contraindications: Unsuitability for general anesthesia or factors affecting surgical safety.
* Drug Allergy: Known allergy to drugs used in the study.
* Implant Conflict: Presence of implanted medical devices that may interfere with VNS therapy.
* Pregnancy or Lactation: Pregnant or breastfeeding individuals.
* Poor Compliance: Inability to adhere to follow-up visits or treatment protocols.
Dexamethasone Plus Virtual Reality Exposure Therapy for PTSD

Evidence from preliminary studies suggests that people with PTSD have heightened fear responses and that cortisol suppression reduces this heightened fear. Research has shown the drug dexamethasone (DEX), a cortisol suppressor, reduces the startle response in civilians with PTSD. This current research proposal represents a blinded, randomized, placebo-controlled efficacy study with the goal of determining whether a drug that suppresses the stress hormone cortisol will increase the efficacy of exposure therapy. Specifically, it is proposed that a dose of DEX, given the night before (approximately 10 hours before) each of 5 to 11 individual virtual reality exposure (VRE) therapy sessions, will significantly enhance the rate of response and possibly the efficacy of treatment. Participants will be treated until they have experienced at least a 70% reduction in PTSD symptoms from baseline or up to 12 sessions or until they and their therapist agree treatment should be terminated, a minimum of 6 sessions to a maximum of 12 sessions. Comprehensive multi-modal outcomes will be assessed by independent assessors blind to subject condition on interviews, self-report measures, and psychophysiological measures. Participants will be assessed pre- and post-treatment and at a follow-up of 3, 6 and 12 months to assess long term effects.


Eligibility Criteria:
Inclusion Criteria:

1. Participants will be 60 males and females between ages of 21 and 65.
2. Participants must meet DSM-V criteria for PTSD due to exposure to a trauma while serving in Operation Iraqi Freedom and/or Operation Enduring Freedom-Afghanistan and Operation New Dawn.
3. Patients must be literate in English.
4. Patients must be medically healthy or medically stable such that the stress of VR and DEX are not contraindicated.
5. Participants must comprehend his or her role in the study and the risks involved in order to be entered.

Exclusion Criteria:

1. Patients with a history of mania, schizophrenia, or other psychoses;
2. Patients with prominent suicidal ideation;
3. Patients with current alcohol or drug dependence;
4. Patients unable to tolerate wearing the VR helmet;
5. Patients unwilling to take study medication;
6. Patients on psychotropic medication(s) must have been on a stable dose for at least 2 weeks prior to beginning the study and must agree not to change their current medication regimen throughout the course of the study. The concomitant use of psychotropic medications will be recorded and examined in data analyses.
7. Patients with special medical conditions such as pregnancy, renal insufficiency, or a history of significant head injury
8. Active medical disorders contributing to psychiatric sx e.g. hypo or hyperthyroidism, SLE, advanced cirrhosis, etc. (per clinical judgment of study physician)
9. Patients stabilized on potentially data-obscuring medications (glucocorticoids).