cyrilzakka/clinical-trials huggingface dataset:
Prospective on Market Patient-reported Outcomes for Milli

To assess the effectiveness of the Milli device in achieving vaginal intercourse

The Milli Vaginal Dilator is a patient-controlled vaginal dilator that provides therapy through distention of the vaginal tissue under electromechanical expansion.

This study is intended to provide data in support of the Milli Vaginal Dilator as a commercially available, over-the-counter medical device.

The Milli has been granted marketing authorization by the FDA under premarket notification K220035 for the following Indications for Use statement:

The Milli Vaginal Dilator is a tool indicated for controlled dilation of the vagina. It can be used for dilation for an examination (by your doctor), in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex.

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Eligibility Criteria:
Inclusion Criteria:

* Subject is a female at birth aged ≥18 years of age
* Subject is able to read and understand the approved, informed consent form (ICF)
* Subject meets vaginismus and related painful sex/GPPPD criteria as defined in the DSM-5, as confirmed by having one or more of the following for greater than 6 months:
* Pelvic pain
* Vaginal pain
* Pain with vaginal intercourse
* Pain with vaginal penetration
* Fear or anxiety about vaginal or pelvic pain with vaginal penetration
* The inability to achieve vaginal penetration
* Subject currently has a sexual partner with a functional penis
* Subject is currently seeking vaginal penetration to achieve sexual intercourse
* Subject is currently unable to tolerate vaginal penetration to achieve sexual intercourse (Score of ≤1 on PEQ Question #1)
* Subject purchased Milli vaginal dilator
* Subject is not contraindicated for Milli vaginal dilator use
* Subject is able and willing to comply with study protocol

Exclusion Criteria:

* Subject has previously participated in any studies by the company in the past 12 months or has used Milli prior to enrollment
* Subject is pregnant
* Subject has an active pelvic infection (vagina or vulva)
* Subject has open wounds in the tissue inside or surrounding the vagina
* Subject has an untreated major mental health disorder (e.g., affective disorder, psychosis, PTSD)
* Subject has prior history of gender-confirming surgery, vaginal reconstruction surgery, pelvic radiation, and/or vaginal procedures that result in extensive scarring (with the exception of hysterectomy procedures)
* Subject or subject's partner experiences other conditions preventing intercourse (e.g., erectile dysfunction, lack of libido)
'Tenofovir Pulse and Peg Interferon Alpha 2b' Therapy in HBeAg-positive Patients With Normal ALT

After fulfillment of the selection criteria, all the patients included in the trial will be administered Tenofovir that will be continued for 3 months and then stopped for 1 month, LFT's, HBV DNA, HBsAg, will be checked weekly during the time period of stopping Tenofovir and thereafter at 4 months patients with ALT \>/= 1.5 times ULN will be randomised in 2 groups to administer either Peg INF alpha 2b + Tenofovir (in same dose as before) or Tenofovir alone which will be continued for 48 weeks and the patients with no rise in ALT will be excluded. Patients will be closely monitored during the period of stopping tenofovir post pulse therapy and liver function tests will be performed weekly. Patients will be closely observed for the development of acute hepatitis or decompensation during the 4 - week period of drug withdrawal. Thereafter, CBC, KFT, LFT's, PT-INR, HBsAg (Q), HBeAg and HBV DNA levels will be tested every 3 months. After stopping treatment followup will be done at 24 weeks post stoppage of treatment to look for sustained seroconversion and virological/biochemical response


Eligibility Criteria:
Inclusion Criteria:

1. Treatment naive chronic HBV infection i.e detectable HBsAg for past 6 months,
2. HBeAg (+),
3. ALT \< ULN (Upper Limit Normal) on 2 or more occasions in last 6 months \[ULN: 45\]
4. HBV DNA \>2000 IU/mL
5. Age \> 18 years

Exclusion Criteria:

1. Decompensated Cirrhosis
2. Severe HBV flare with reactivation
3. Presentation as ACLF (Acute on Chronic liver Failure)
4. Baseline ALT \> ULN (Upper Limit Normal)
5. Contraindications to PEG-IFN therapy
6. Prior HBV antiviral therapy within 6 months of enrollment
7. Co-infections with HCV/HIV
8. ANA +(autoantibodies suggestive of autoimmune disease) \>1:80
9. Patient not willing for enrollment in the study
10. Pregnancy, lactation
11. Patients who leave the study/ discontinue the therapy before completion
Comparison of 18F-fluorodeoxyglucose Positron Emission Tomography and Coronary Computed Tomography in Assessing Vascular Inflammation

Vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.cardiac multidetector-row CT can provide measurements of coronary artery calcium (CAC), the degree of stenosis, and the characteristics of plaque including its potential vulnerability. Therefore, the purpose of the investigators study is to compare the usefulness of 18 FDG-PET and MDCT in assessing the vascular inflammatory status and vulnerability.


Eligibility Criteria:
Inclusion Criteria:

* Healthy patients for visiting routine medical check in our clinic

Exclusion Criteria:

* History of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization)
* Diabetes
* Stage 2 hypertension (resting blood pressure, ≥ 160/100 mmHg)
* Malignancy
* Severe renal or hepatic disease
* Subjects taking medications that might affect inflammation such as NSIAD and statin
Development and Evaluation of an Adult Burn Prevention Program

The aim of this study was to evaluate the effectiveness of a targeted burn prevention message on burn safety knowledge and behavior.

Flammable liquid burns comprise 23% of admissions to our burn center. This was a project to test the uptake of the message "Don't be a Flaming Fool" delivered via multi-media campaign.

Eligibility Criteria:
Inclusion Criteria:

* male 16 years of age or older

Exclusion criteria

* males less than 16 years of age
* females
Intracellular Pharmacokinetics of Zidovudine Triphosphate in Maternal and Infant Cord Blood Mononuclear Cells.

To determine the levels of zidovudine triphosphate ( AZT-TP ) in maternal and fetal cord blood mononuclear cells. To determine the ratio of AZT-TP to endogenous nucleoside triphosphate levels in maternal and fetal cells. To determine the extent of drug transfer through the feto/placental unit.


Eligibility Criteria:
The Effect of Using Virtual Reality Glasses on Post-Care Pain and Comfort Level in Intensive Care Patients

The aim of this study is to determine the level of pain and comfort associated with the implementation of virtual reality prior to nursing care in patients undergoing treatment in the intensive care unit. The research will be conducted in the Internal Medicine Intensive Care Unit of a university hospital.

The aim of this study is to determine the level of pain and comfort associated with the implementation of virtual reality prior to nursing care in patients undergoing treatment in the intensive care unit.

The study will be conducted in the Internal Medicine Intensive Care Unit of a university hospital. The study population will consist of patients admitted to the internal medicine unit who are between 18 and 65 years of age, are conscious with a Glasgow Coma Scale (GCS) score of 10 or above, have no auditory or visual impairments, and are not receiving mechanical ventilation support.

A total of 60 patients will be included in the study and randomly assigned into two groups: 30 in the experimental group and 30 in the control group.

Data will be collected through face-to-face interviews using a Sociodemographic Characteristics and Information Description Form, a Visual Analog Scale (VAS), and the General Comfort Scale - Short Form (GCS-SF).

The intervention for the experimental group will include viewing calming videos using a virtual reality headset before nursing care. Pain and general comfort levels will be evaluated 24 hours after the nursing care procedure.

Statistical analyses such as percentage calculations, t-test, Mann-Whitney U test, and Spearman correlation analysis will be used to evaluate the data.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who are hospitalized in the intensive care unit (with diagnoses such as cancer, chronic renal failure, heart failure, gastrointestinal bleeding, COPD, DM, etc.) and volunteer to participate in the study.
* Between the ages of 18-65,
* Having clear consciousness, orientation to place, time and person, and having a GCS score of 10 and above,
* Individuals who do not have any hearing or visual impairment,
* They were determined as individuals who were not on mechanical ventilation support.

Exclusion Criteria:

* Receiving mechanical ventilation support
* Individuals under 18 years of age and over 65 years of age
Risperidone and Zotepine in the Treatment of Delirium

Delirium is an organic psychiatric syndrome characterized by fluctuating consciousness and impairment in perception, cognition and behavior. In hospitalized elderly, the prevalence of delirium ranges from 10% to 40%. If untreated, delirium is associated with significant morbidity and mortality. Treatment of delirium consists of identifying and managing underlying medical abnormalities and the associated psychiatric symptoms. Conventional antipsychotics have been the mainstay of treatment of agitation and psychosis associated with delirium; but their use is limited in terms of EPS side effects. Second-generation antipsychotic agents have been reported to have a lower incidence of extrapyramidal side effects and tardive dyskinesia which has resulted in their increased use in the treatment of delirious patients. However, there is still no consensus regarding standard pharmacologic treatment of this syndrome that takes use of second-generation antipsychotic agents into account.

Risperidone and zotepine have a lower incidence of EPS and are effective in treating disturbing psychotic behaviors. We hope to compare the efficacy and safety of risperidone and zotepine in the treatment of delirium and the correlation between the severity of delirium with autonomic dysfunction.

Qualified inpatients will be enrolled and randomly given a flexible-dose regimen of Risperidone or Zotepine. Autonomic dysfunction is checked using analysis of heart rate variability before any active drug given. The initial starting dose of each drug is 1mg(risperidone) or 50 mg(zotepine) once a day. The dosage was increased depending on the status of delirium during the first 7 days and will be adjusted until patients are maximally stabilized or until intolerable adverse events necessitated cessation. Risperidone or zotepine will be tapered off in 10 days when patients are considered stable. No concomitant psychotropic medications will be used during the study except for lorazepam, which are given for severe agitation or insomnia . Patients are assessed by another rater blinded to active drug at the time of enrollment, the subsequent 12, 24,and then assessed daily until discharge. The study period is estimated to be around 12 months upon the designed number of subjects are reached.

Eligibility Criteria:
Inclusion Criteria:

* Patients may be included in the study if they meet all of the following criteria:DSM-IV-TR delirium (293.0 delirium due to general medical condition, 290.3 dementia with delirium 290.41, arteriosclerotic dementia with delirium 780.09delirium NOS. 292.8 substance-induced delirium( excluding alcohol and BZD)
* Age 18 to 85 year-old inpatients; either sex
* Patients are able to take Risperidone or Zotepine orally

Exclusion Criteria:

* Alcohol-induced delirium; delirium caused by seizures; Sedative, hypnotic or anxiolytic withdrawal delirium
* Patients with schizophrenia or bipolar disorder or being treated with antipsychotics
* Patients are mandatory to take parenteral treatments
* Patients are known to be allergic to Risperidone or Zotepine
* Women with pregnancy or during lactation.
OD vs. TID Dosing With Mesalazine Granules in Active Ulcerative Colitis

To proof the therapeutic equivalence of once daily (OD) versus three times daily (TID) dosing of total 3.0 g mesalazine granules in patients with active ulcerative colitis


Eligibility Criteria:
Inclusion Criteria (main):

* Active ulcerative colitis except proctitis, i.e. inflammation minimal 15cm ab ano, confirmed by endoscopy and histology
* Established or new diagnosis
* Disease activity at baseline: Clinical Activity Index (CAI) \>4 and Endoscopic Index (EI) \>= 4

Exclusion Criteria (main):

* Crohn's disease
* Toxic megacolon
* Present or past colorectal cancer
* Symptomatic gastrointestinal disease
* Serious secondary disease(s)
* Baseline stool positive for germs causing bowel disease
* Immunosuppressants within 3 months and/or corticosteroids within 1 month prior to baseline
* Current relapse occurred under maintenance treatment with \>2g/day mesalazine
* Serum creatinine \>= 1.2x upper limit of normal (ULN) and creatinine clearance \< 60 ml/min per 1.73 m2
* Serum transaminase (ALT and/or AST), and/or alkaline phosphatase \>= 2x ULN
Immediate Effect of Dynamic Stretching With and Without Floss Band on Flexibility of Hamstrings in Futsal Players

To compare the immediate effect of dynamic stretching with and without floss band on the hamstring flexibility in futsal players.

Futsal is a soccer-like indoor sport that has been gaining popularity worldwide.To increase the flexibility and ROM of involved muscle group a new method has been introduced named Flossing of tissue by using a floss band.

This research study will be helpful to enable therapists to broaden their treatment plans or choose better treatment tools for improving hamstrings flexibility in futsal players. Thus, this study has been designed with the purpose to examine the effect of dynamic stretching with and without floss band on the flexibility of the hamstring.

Eligibility Criteria:
Inclusion Criteria:

* National level futsal players.
* Active for past 3 months.

Exclusion Criteria:

* Players with any systemic disease/disorder.
* Players with any recent ligamentous or musculoskeletal injury that isn't healed yet.
Beijing Hospital Atherosclerosis Study

The Beijing Hospital Atherosclerosis Study (BHAS) is a prospective, single-center, observational cohort study performed at the Beijing Hospital in Beijing, China. Subjects enrolled in this study will be the consecutive patients undergoing coronary angiography in the hospital. Blood samples are taken immediately before the angiographic procedure. Clinical and angiographic characteristics are recorded. All patients will have routine follow-up at 6 months and 1 year postprocedure, then yearly thereafter. Follow-up includes mortality, myocardial infarction (MI), stroke, rehospitalization, coronary revascularization procedures, life styles, and medication use. The primary end point for the study will be the major adverse cardiovascular events (MACE), defined as death from any cause, nonfatal myocardial infarction, nonfatal stroke and revascularization. This study has been reviewed and approved by the Ethics Committee of Beijing Hospital. All enrolled individuals will be received written notice of the intended use of their blood samples and provided written consent.

The major objectives of the BHAS Study are to (1) establish a prospective cohort and a biological sample bank in ethnic Chinese with coronary angiography, (2) identify baseline new biosignature profiles such as novel biomarkers via metabolomics approach associated with the subsequent clinical events, (3) assess the use of molecular profiles from multiple platforms (eg, genomics, proteomics, and metabolomics) integrated with readily available clinical information for improved risk classification for cardiovascular events, and (4) provide clearer understanding of underlying disease processes.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18y
* Consent for the study
* Primary reason for catheterization is concern for ischemic heart disease
* Complete clinical and coronary angiogram data available

Exclusion Criteria:

* Primary pulmonary hypertension or severe lung disease
* Cardiac transplantation
* Other solid organ transplant
* Peripheral vascular intervention only
* Right heart catheterization only
* Advanced heart failure
* Congenital heart disease
* Women who are pregnant or nursing, or preparing for pregnant during the study period
* Progressive fatal disease
* History of alcoholism or drug abuse
* Patients with mental illness and are being treated
* Patients are undergoing radiotherapy or chemotherapy
* Acute and chronic infectious diseases
Pregabalin Effects on Hypotensive Anesthesia During Spine Surgery.

Elective lumbar spine surgical procedures are commonly performed under controlled hypotension during general anesthesia. That is beneficial to limit the intraoperative blood loss and transfusions and improves surgical field. Deliberate hypotension could be achieved via various medications but mostly associated with significant side effects. Pregabalin effectively augmented hypotensive anesthesia. The hypothesis is that Pregabalin 150 mg single preoperative dose may augment intraoperative deliberate hypotension that will be reflected on blood loss and nitroglycerin consumption.

An arterial line will be established then general anesthesia will be conducted. After adequate preoxygenation, anesthesia induction by IV fentanyl 1.5µg/kg, propofol 2 mg/kg, and atracurium 0.5 mg/kg then appropriated size tracheal tube. The ventilator settings will be adjusted to maintain the end-tidal carbon dioxide tension (ETco2) at 30-35 mm Hg. Anesthesia will be maintained by isoflurane concentration 1.2%, with 40% oxygen in air then IV infusion of fentanyl 0.05 mcg/kg/min was started while atracurium 0.1 mg/kg incremental dose as required. Then patients will be turned into the prone position above pad support permitting free hanging of the abdomen. Intraoperatively, the target mean arterial arterial blood pressure (MBP) is 55-65 mm Hg. After surgical incision, if MBP exceeds 65 mm Hg (defined as hypertension) it will be managed by: increasing isoflurane MAC up to 2%, if no response after 5 min, Nitroglycerin infusion initiated at 0.5 mcg/kg/min to 40 mcg/kg/min. Hypotension (MBP \<55 mm Hg) will be treated by stopping nitroglycerin, proper compensation of losses, reducing Isoflurane MAC. If persisted; vasoactive drugs will be used. Bradycardia (HR \<50 beat/min.), treated with 0.01 mg/kg atropine IV increments.

The nitroglycerin infusion will be stopped after the finial surgical hemostasis. Fentanyl infusion will be stopped before ligament sutures. Isoflurane will be closed after the last surgical suture. After dressing, patient will be turned to the supine position and morphine 0.025 mg/kg IV will be administered then 0.04 mg/kg neostigmine and 0.015 mg/kg atropine for reversal. Extubation will be done after establishment of acceptable spontaneous respiration.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) score I-II
* admitted to undergo lumbar discectomy or spinal fixation surgery under general anesthesia

Exclusion Criteria:

* Patients on anti-hypertensive treatment, diuretics, corticosteroids, pregabalin, gabapentin, anticonvulsants, antipsychotics,
* alcohol addiction or drug abuse
* patients with history of allergy to any drug used in the study .
* pregnant or nursing women
* patients with peripheral neuropathy, endocrinal diseases, bleeding abnormality,
* cardiac, hepatic or renal impairment
Validation of Functional Imaging as Predictive Tool for Outcome of Mandibular Replacement Appliance Therapy in Obstructive Sleep Apnea Hypopnea Syndrome Patients

In this open prospective study 40 patients who received Mandibular Replacement Appliance (MRA) Therapy as treatment of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) will be included. The patient's sleep will be registered during 2 periods of 2 days: one while the patient does not wear the MRA and, +/- 1 week later, one while the patient wears the MRA. Furthermore, 2 low dose CT scans (one with and one without the MRA device in the mouth) will be taken. These data must allow the investigators to validate the use of functional imaging (segmentation and Computational Fluid Dynamics) as a predictor of the outcome of the MRA therapy in OSAHS patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with documented OSAHS based on the following criteria:

   AHI \>= 5 Complaints of extreme daytime sleepiness with no other explanation and/or 2 or more of the following symptoms:
   * choking or gasping during sleep
   * recurrent awakenings from sleep
   * un-refreshing sleep
   * daytime fatigue
   * impaired concentration
2. Patients who received MRA as treatment for OSAHS
3. AHI \>= 5 on at least 1 of the screening nights (patient does not wear MRA device)
4. Male or female patients aged ≥ 18 years
5. Patients with a co-operative attitude
6. Written informed consent obtained

Exclusion Criteria:

1. Pregnant or lactating females or females at risk of pregnancy
2. Patients with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.
3. Cancer or any other chronic disease with poor prognosis and/or affecting patient status
4. History of alcohol or drug abuse in the last 2 years
5. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
6. Patients who participate in another clinical study whose investigational plan is judged to interfere or affect any of the measures of this study
Safety and Efficacy of the LMA Supreme When Inserted With Patients in the Prone Position

This study is a non-randomized, observational, non-comparative prospective study to evaluate the safety, efficacy and performance of the LMA Supreme laryngeal mask airway when used according to the device's Instructions for Use.

This study is a non-randomized, observational, non-comparative prospective study to evaluate the safety, efficacy and performance of the LMA Supreme laryngeal mask airway when used according to the device's Instructions for Use. During surgery, standard treatment will be applied, complemented with the recording of study parameters related to safety, efficacy and performance of the LMA Supreme laryngeal mask airway.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years of age
* American Society of Anesthesiology Classification (ASA) I-III patients
* Fasting for 8 hours
* Scheduled surgery with indication for laryngeal mask airway

Exclusion Criteria:

* Have contraindicating conditions
* Have had radiotherapy to the neck involving the hypopharynx (risk of trauma, failure to seal effectively).
* Have inadequate mouth opening to permit insertion
* History of hiatal hernia
* Scheduled for minimally invasive spine stabilization procedures such as Transforaminal Lumbar Interbody Fusion (TLIF), Anterior Cervical Discectomy and Fusion (ACDF) (all have neuromonitoring/general endotracheal intubation)
* Scheduled for Joimax procedure (initial anesthetic is MAC)
* Unable to safely position themselves prone with assistance
* History of previous failed LMA Supreme placement
* BMI greater than or equal to 53
* Outside age or ASA range specified in inclusion criteria
* Inability to comply with study requirements including follow-up