cyrilzakka/clinical-trials huggingface dataset:
Key Dimensions of PTSD and ED

This study will test whether endothelial dysfunction could be the early subclinical mechanism by which posttraumatic stress disorder (PTSD) increases cardiovascular disease (CVD) risk, and whether posttraumatic fear-a key component of PTSD-or another PTSD dimension could be the target to offset that risk. The results of this study may help trauma-exposed individuals who are at risk of having CVD events.

Posttraumatic stress disorder (PTSD) increases risk of incident cardiovascular disease (CVD) by 25-50%. Most individuals (50-90%) experience a traumatic event in their lifetime, and PTSD is the fifth most common psychiatric disorder. Experts have now called for increased CVD surveillance after trauma and for PTSD treatment trials powered to reduce CVD risk. However, both CVD risk and PTSD are complex phenomena that likely interact in nuanced ways. This study will determine which PTSD dimension(s) contribute to endothelial dysfunction, one of the earliest modifiable precursors to CVD. The investigators will examine cross-sectional and longitudinal associations of PTSD and its underlying dimensions with functional and, secondarily, cellular measures of endothelial dysfunction (FMD and circulating endothelial cell-derived microparticles, respectively) in a community-dwelling sample of CVD-free adult men and women with a history of trauma (50% with current PTSD).

Eligibility Criteria:
Inclusion Criteria:

* Aged 18+ years
* History of exposure to a psychological trauma (e.g., natural disaster, physical assault)
* Fluent in English
* Willing to and capable of providing informed consent

Additional Inclusion Criteria for the PTSD Group

* Diagnosed with current PTSD (duration of at least 1 month) using the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual 5th Edition (DSM-5) (CAPS-5) at the diagnostic interview assessment

Exclusion Criteria:

* History of CVD (i.e., diagnosis of myocardial infarction, unstable angina, heart failure, peripheral artery disease, or stroke)
* Deemed unable to comply with the protocol (either self-selected or by indicating during screening that could not complete all requested tasks)
* Current bipolar disorder or psychotic disorder
* Mild or more severe cognitive impairment \[Mini-Mental State Exam (MMSE)3 score ≤18\]
* Current moderate or severe substance use disorder
* Acute, unstable, or severe medical disorder or pregnancy
* Deemed to need immediate psychiatric intervention (e.g., active suicidality)
* Use of antipsychotic, mood stabilizer, antidepressant, or stimulant medication in the past 4 weeks
* Daily benzodiazepine use in the past 2 weeks

Additional Exclusion Criteria for the Trauma-Exposed Matched Control Group

* Current or past diagnosis of any DSM-5 psychiatric disorder
* CAPS-5 total score ≥25
A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

The purpose of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL. Participants may or may not have already had treatment for their cancer. Participation could last up to six years.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
* Adequate organ function

  * Platelets greater than or equal to ≥ 50 x 10⁹/liter (L) or ≥30 x 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis,
  * Hemoglobin ≥8 grams/deciliter (g/dL) or ≥6 g/dL in participants with documented bone marrow involvement considered to impair hematopoiesis
  * Absolute neutrophil count ≥0.75 x 10⁹/L or ≥0.50 × 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis
  * Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL/min)

Exclusion Criteria:

* Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment
* Known or suspected central nervous system (CNS) involvement
* A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease
* Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia \[AIHA\], idiopathic thrombocytopenic purpura \[ITP\])
* Significant cardiovascular disease including ejection fraction \< 40% and any grade ongoing atrial fibrillation or atrial flutter
* Hepatitis B or hepatitis C testing indicating active/ongoing infection, based on Screening laboratory tests
* Active cytomegalovirus (CMV) infection
* Active uncontrolled systemic bacterial, viral, or fungal infection
* Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
* Clinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatments
* Ongoing inflammatory bowel disease
* Prior exposure to BTK inhibitor (covalent or noncovalent)
* Concurrent use of investigational agent or anticancer therapy except hormonal therapy
* Participants requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
* Use of \> 20 mg prednisone daily or equivalent dose of steroid at the time of first dose of study drug
* Vaccination with a live vaccine within 28 days prior to randomization
* Participants receiving chronic therapy with a strong cytochrome P450 (CYP)3A inhibitor (except posaconazole and voriconazole) which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment
* Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib
Clinical Evaluation of the Causes of Contact Lens Related Dry Eye

The purpose of this study was to clinically evaluate the potential causes of contact lens-related dry eye.

Daily wear soft contact lens wearers reporting significant contact lens-related dryness symptoms were enrolled. Late day dryness with contact lenses, intensity grade 3-5, frequency "sometimes / frequently / constantly" as evaluated by a questionnaire was considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Reports late-day dryness symptoms with contact lens wear on questionnaire.
* Wears FDA Group 2 hydrogel, FDA Group 4 hydrogel, or silicone hydrogel lenses.
* Consistently uses either polyhexamethylene biguanide (PHMB) or polyquaternium-1 (PQT) contact lens care products (i.e. \>6 months including 1 month immediately before enrollment).
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Wears daily disposable contact lenses.
* Has significant symptoms related to lens fit or lens deposits.
* Requires concurrent ocular medication (rewetting drops allowed).
* Has used Restasis® in the last 3 months.
* Wears punctal plugs fitted in the last 30 days.
* Has any current systemic or ocular abnormality, infection or disease.
* Uses any current systemic medication likely to affect tear film, e.g. antihistamines, betaadrenergic blockers, steroids.
* Has a history of refractive surgery.
* Other protocol-defined exclusion criteria may apply.
Post-Market Clinical Follow-Up to Access & Visualize the Anus, Rectum, & Distal Colon During Transanal Procedures

To assess the safety and performance of the Medrobotics Flex Robotic System and Flex Rectoscope for accessing and visualizing the Anus, Rectum, and Distal Colon when used for Transanal procedures


Eligibility Criteria:
Inclusion Criteria:

* ≥ 22 years of age
* Candidate for transanal procedures in the areas of the anus, rectum, and distal colon.

Exclusion Criteria:

* Candidates are excluded if they \< 22 years of age and do not meet criteria for transanal surgery in the anus, rectum, and distal colon
Effectiveness of an Online Psychoeducation Program for Improving Coping in People With a High Level of Dissociative Symptoms: A Pilot Randomized Waitlist-controlled Trial

Subject Population Our study's target population is people with pathological dissociation in the community.

Research Design A pilot randomized waitlist-controlled trial will investigate the effects of an online psychoeducation program on coping, symptom management, and self-efficacy of people with pathological dissociation immediately (posttest-1) and 2-month (posttest-2) post-intervention. Supplementary semi-structured interviews will be conducted for process evaluation. The analysis and reporting of the trial will strictly follow the CONSORT guidelines.

Instrument The primary outcome of our study is the coping ability of individuals with pathological dissociation, which will be assessed by the Brief Coping Orientation to Problems Experienced Inventory (Brief-COPE). The secondary outcome measures are dissociative symptoms, emotional regulation, and self-efficacy, which would be assessed by the Dissociative Experiences Scale-Taxon (DES-T), the Emotion Regulation Questionnaire (ERQ), and the General Self-Efficacy Scale (GSES) accordingly.

Procedure The online psychoeducation program is developed based on an integrative theoretical framework that integrates the Stress and Coping model, Cognitive-Behavioural Theory, Bandura's self-efﬁcacy theory, and findings of our previous feasibility studies on this psychoeducational program. Participants will be recruited via posting on social media and online forums. A 16-session online psychoeducation program will be delivered to the participants in eight weeks.


Eligibility Criteria:
Inclusion Criteria:

* agree to give informed consent and participate
* aged 18 or above
* self-reported symptoms or experiences of pathological dissociation
* screened positive on the Chinese version of the DES-T (i.e., DES-T score 20 or above) at a baseline screening
* able to understand and communicate in Chinese-Cantonese
* have access to the internet.

Exclusion Criteria:

* Individuals who have a reading disorder, cognitive impairment, dementia, or intellectual disabilities
* Individuals who are participating in any research studies
* Individuals who had participated in our previous feasibility study of the same intervention
Evaluation of a Serious Game Aimed at Improving Mental Health in Youth.

The main goal of this study is to evaluate the effectiveness of a serious game aimed at improving mental health in teenagers aged 12-16 years old. This will test the effectiveness by studying the effect on emotion regulation strategies, coping strategies, the presence of cognitive errors and suicidal ideation. Participants will also be asked to evaluate the game. The study is a cluster-randomized controlled trial conducted in secondary schools in Flanders.


Eligibility Criteria:
Inclusion Criteria:

* Dutch speaking
* having access to a smartphone or tablet

Exclusion Criteria:

* not being part of the selected classes in the participating schools
POSE - POs Surgery Endometrial Cancer

This phase I/II feasibility study of hypo-fractionated, image-guided Volumetric Modulated Arc Therapy (VMAT) Stereotactic Body Radiotherapy (SBRT) to the vaginal cuff in intermedium and high risk endometrial cancer. The primary endpoints are SBRT feasibility and dosimetrical reproducibility to HDR brachytherapy, inter/intra-fractional target motion assessment and toxicity rates. Secondary endpoints are quality of life measures, local control, disease free survival and overall survival.

This phase I/II feasibility study of hypo-fractionated, image-guided Volumetric Modulated Arc Therapy (VMAT) Stereotactic Body Radiotherapy (SBRT) to the vaginal cuff aims to reproduce adjuvant High Dose Rate (HDR) brachytherapy dose distributions in patients operated for intermediate and high risk endometrial carcinoma. The study will employ devices to accurately reproduce pelvic anatomy and mitigate target motion and will make use of real-time on-line tracking. Eligible patients will receive three SBRT sessions to a prescription dose of 7 Gy to the vaginal cuff (with 4 to 7 days interval). SBRT will start within 4 to 8 weeks post-hysterectomy. The study will enroll a total of 30 patients. After treatment, patients will be followed-up at 3 months (+/- 6 weeks), at 6 (+/- 6 weeks) and every 6 months (+/- 6 weeks) thereafter for a total of 2 years. The duration of accrual in the study will be up to 3 years. Toxicity and outcome will be compared to published data on the standard modality of care (HDR brachytherapy). Patients' quality of life measures will be collected with validated questionnaires at the baseline and during follow up. Recurrence rates and survival data will be reported.

Eligibility Criteria:
Inclusion Criteria:

* Pathology proven adenocarcinoma of the endometrium
* National Comprehensive Cancer Network (NCCN) intermediate and high risk
* Unstaged patients with \< 50% myometrium invasion;
* Age ≥ 18;
* World health organization - Eastern Cooperative Oncology Group (WHO-ECOG) performance status 0-2 or Karnofsky performance status (KPS) ≥ 70;
* Hemoglobin ≥ 8.0 g/dl; white blood cells count (WBC) ≥ 1,500/mm3 ; Platelets ≥ 40,000 cells/mm3 .
* Signed informed consent

Exclusion Criteria:

* Evidence of post-surgical macroscopic residual disease;
* Patients with anatomical incompatibility with online tracking device;
* Psychiatric conditions;
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years;
* Prior radiation therapy to the pelvis that would result in overlap of radiation therapy fields;
* Severe active co-morbidities.
Evaluation of 2%Bromelain Gel With 0.2%CHX Gel as Subgingival LDD Following SRP in Stage II/III and Grade B Periodontitis -A RCT

The current study is a prospective randomised study Evaluation of 2%Bromelain Gel With 0.2%Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing in Stage II/III and Grade B Periodontitis

36 sites with periodontal pocket depth measuring 4-6mm were selected. The sites selected were divided into

1. Group I (Control)- 12 sites with Probing depth of ≥5mm treated with scaling and root planing alone.
2. Group II -12 sites with Probing depth of ≥5mm treated with scaling and root planing followed by placement of bromelain gel.
3. Group III -12 sites with Probing depth of ≥5mm treated with scaling and root planing followed by placement of chlorhexidine gel.

periodontal pack was placed and patient was recalled at 1week,4th week and 12th week

Eligibility Criteria:
Inclusion Criteria:

* Patient with have chronic periodontitis in the age group between 30-50 years.
* Patients having ≥20 teeth.

  -.Patients with radiographic evidence of bone loss in atleast two teeth.
* Patients who are systematically healthy.
* Patients with localized pockets with probing depth of ≤ 5mm.
* Patients who are cooperative and able to attend the hospital for regular follow-up.

Exclusion Criteria:

* Patients who have received any surgical or nonsurgical therapy during past 6months
* Pregnant or lactating females.
* Use of systemic antibiotics in the past 6 months.
* Patient who are not willing to give a written informed consent
ReCap Total Hip Resurfacing Prospective Data Collection

Prospective data collection on survivorship of ReCap Total Hip Resurfacing

Detailed protocol not available

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hip joint arthritis

Exclusion criteria:

- less than 18 years of age
Tranexamic Acid in Cyanotic Heart Defects

The use of antifibrinolytic agents such as to reduce blood loss in congenital cardiac surgery has been described in many studies

40 patients in each one of the three groups; In control group will receive normal saline, Intravenous Tranexamic acid group received 50 mg / kg intravenousely followed by of 1 mg/kg/hr.for six hours. The topical Tranexamic acid group will have 50 mg / kg of tranexamic poured into the pericoredial cavity. in the first 24 hours we will measure the total blood loss and transfusion requirements. Complate blood picture and coagulation studies will be recorded. the occurrence of re-exploration for excess bleeding, or adverse events.

Eligibility Criteria:
Inclusion Criteria:

2 to 12 years cyanotic cardiac disease with cardio pulmonary bypass

Exclusion Criteria:

Previous cardiac surgery any operation within 48 hr., previous inotropes or mechanical vention aprotinin exposure Liver or renal impairment Coagulation or hemostatic dysfunction within the last 7 days before surgery.
A Study to Assess the Abuse Potential of Intranasal Cebranopadol

The purpose of this study to Assess the Abuse Potential of Intranasal Cebranopadol Compared to Oxycodone and Placebo in Healthy, Nondependent Recreational Opioid Users.

This study will be conducted to examine the intranasal abuse potential of cebranopadol compared with oxycodone HCl IR and placebo in recreational opioid users with intranasal experience, a Dose Escalation Phase (Part A) will first be conducted to determine a safe dose for evaluation in the Main Study (Part B).

The Dose Selection Phase (Part A) will consist of 3 phases: Screening, Treatment and Follow-up. Subjects will participate in an outpatient medical screening visit, a 4-day treatment visit and a follow-up phone call.

The Main Study (Part B) will consist of 4 phases: Screening, Qualification, Treatment and Follow-up. Subjects will participate in an outpatient screening visit, a 4-day Qualification Phase, a 30-day Treatment Phase and a follow-up phone call.

Eligibility Criteria:
Key Inclusion Criteria:

* Experienced opioid user who meets the following criteria: (1) has used opioids for nontherapeutic purposes (i.e., for psychoactive effects) on at least 10 occasions in the year prior to Screening; (2) has used opioids at least once in the 12 weeks prior to Screening; and (3) self-reported intranasal use of drugs of abuse on at least 3 occasions in the year prior to Screening.
* Subjects must be in good health as determined by medical history, physical examination, 12-lead ECG and vital signs measures (pulse rate, systolic and diastolic blood pressure, respiratory rate and oxygen saturation using pulse oximetry) at Screening.
* Subjects must be willing to comply with the requirements and restrictions of the study.

Key Exclusion Criteria:

* Drug or alcohol dependence in the 12 months prior to Screening (except nicotine), as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR), or any self-reported dependence or "addiction" within the subject's lifetime (except nicotine or caffeine).
* Subjects who have ever been in treatment for substance use disorder(s) (except smoking cessation).
* History or presence of any clinically significant cardiac, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal or other disease at Screening, which, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
* Clinically significant abnormalities in the intranasal cavity (including a deviated septum, perforated nasal septum, rhinorrhea, or excessive sneezing) or any condition that, in the opinion of the investigator, would interfere with the study procedures, data integrity or would compromise the safety of the subject. Subjects with nasal piercings/nose rings will be required to remove them for the duration of their inpatient stay.
Effects of Dihydropyridine Calcium Channel Inhibitors on Respiratory Gas Exchanges in the Intensive Care Unit: a Pharmacovigilance Study in VigiBase® and a Comparison With Urapidil

Due to their effects on hypoxic pulmonary vasoconstriction (HPV), dihydropyridine calcium channel inhibitors (CCI) could lead to hypoxia in patients with a pulmonary shunt. To the present time only preclinical studies and case reports focused on this potential adverse drug reaction. We aimed to assess the reporting association between CCI and hypoxia using the World Health Organization pharmacovigilance database (VigiBase®).


Eligibility Criteria:
Inclusion Criteria:

* present in the database

Exclusion Criteria:

* chronology not compatible with the drug imputability
Sensory Processing in Subjects With Painful Bladder Syndrome

The purpose of this study is to determine if clinically relevant subsets exist in patients meeting the diagnosis of Painful Bladder Syndrome (PBS). Subsets suggest differential responses to treatments and if verified, this will be important for the stratification of patients in clinical studies related to PBS.

Patients with the diagnosis of painful bladder syndrome (PBS) constitute two or more phenotypes that are distinguished by differential neurophysiological processing of sensory information. Further, these differing phenotypes can be predicted by the presence or absence of the co-morbidity fibromyalgia.

Eligibility Criteria:
Inclusion Criteria:

* NIDDK criteria for Painful Bladder Syndrome
* Age 19 years or older
* Must be able to read and speak English since testing materials are validated in English

Exclusion Criteria:

* PBS subjects must be independent of co-existing pain disorders or use of medications
* Uncontrolled hypertension or significant cardiopulmonary disease
* No chronic daily pain
* Older than 75 years of age
Caffeinated Gum Softball Performance

The purpose of this study was to investigate the effects of caffeinated chewing gum on female softball pitching and hitting performance. 24 trained female softball players (10 pitchers and 14 fielders) were divided into a caffeine chewing gum trial (CAF) or a placebo trial (PLA) in a single-blind, randomized, crossover experimental design. Two pieces of gum containing 100 mg of caffeine (CAF) or without caffeine (PLA) were chewed for 10 minutes and then spit out, followed by a 15-minute warm-up. The physical tests included grip strength and countermovement jump. The softball-specific tests included pitching (fast ball speed) or hitting (exit speed). The two trials were separated by seven days.

This study utilized a randomized, crossover, single-blind experimental design. At least two familiarization tests were conducted one week before the formal trial to ensure each participant was familiar with the experimental procedures. Before the first formal trial, participants were randomly assigned to either the caffeinated chewing gum trial (CAF) with 200 mg of caffeine or the placebo trial (PLA) without caffeine, seven days apart (Figure 1). The primary outcome was the pitching and hitting performance, and the secondary outcomes were hand grip strength and height of countermovement jump.

Eligibility Criteria:
Inclusion Criteria:

* 1. adult female; 2. at least six years of professional softball training and familiarity with all softball skills; 3. caffeine intake of less than 80 mg daily.

Exclusion Criteria:

* 1. not professionally trained; 2. having a medical condition for which exercise is not recommended, such as hypertension, hyperlipidemia, or heart disease; 3. having any musculoskeletal injuries within the last six months or not being able to complete a full trial; 4. having a history of caffeine allergy.