cyrilzakka/clinical-trials huggingface dataset:
VITOM Study: A Randomized, Controlled Trial.

This is research in which students are queried by questionnaires on their satisfaction with and experience with certain educational practices (use of a camera image projecting during a live surgery) or with pre-recorded video. As data collection only involves survey data collection and satisfaction with an educational experience, and randomization/intervention is only involving use of one type of educational method versus another .

As better training in vaginal surgery is a priority of gynecologic safety and quality organizations, optimizing learner satisfaction with vaginal surgery learning experiences is of paramount importance. Our purpose was to investigate if this unique camera system may have advantages in learner satisfaction both in the operating room and in video learning settings, therefore increasing the interest of the learner pool in vaginal surgery and optimizing their experience. This study has two main, non-dependent aims:

Aim 1: The investigators aim to perform a randomized, controlled trial that compares a vaginally-mounted high-definition telescopic camera system (VITOM®) that can project live images in the operating room during vaginal surgery to traditional learner surgery observation practices, with the primary outcome of learner satisfaction as measured by validated adult learner satisfaction measures.

Aim 2: The investigators aim to investigate in a randomized, controlled trial whether learners watching videos acquired with the VITOM® camera feel the video is more learner-friendly and optimal that videos acquired with traditional, tripod-mounted standard definition cameras.

Eligibility Criteria:
Inclusion Criteria:

* Adult learners (age \>=18 years)
* Residents and medical students rotating in the field of gynecology at the University of Louisville and within the group of learners who are available to observe and participate in surgeries with the Urogynecologic team at any of the study sites.

Exclusion Criteria:

* Adult learners will be excluded if they have participated in the study prior, are performing a role within the surgery that precludes their participating in one of the study arms.
* If it is deemed by the surgical team that participation of the learner in the study or filming of the surgery would compromise the quality of surgery or patient safety in any manner.
Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adults With COVID-19

This is a placebo-controlled study to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19.

This is a multi-center, randomized, double-blind, placebo-controlled study designed to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19. Subjects will receive 100 mg of COVI-AMG, 200 mg of COVI-AMG, or placebo via slow IV push. Subjects will be followed for approximately 70 days post dosing.

Eligibility Criteria:
Inclusion Criteria:

* Positive for COVID-19 by an approved antigen test
* Progressive disease suggestive of ongoing COVID-19 infection
* Requires hospitalization for acute medical care
* Provides written informed consent
* Willing to follow contraception guidelines during study

Exclusion Criteria:

* Requires high-flow oxygen supplementation
* Current or imminent respiratory failure
* Has rapidly progressing symptoms that in the investigator's opinion are likely to progress to needing high-flow oxygen or to respiratory failure within 24 to 48 hours
* Any condition which, in the investigator's opinion, participation would not be in the subject's best interest or could prevent, limit, or confound the protocol-specified assessments
* Has participated, or is participating in, a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies against SARS-CoV-2, or intravenous immunoglobulin within 3 months or less than 5 half-lives of the investigational product (whichever is longer)
* Pregnant or lactating and breast feeding, or planning on either during the study
* Unable to comply with planned study procedures and be available for all follow-up visits
Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With A Reference Product

The purpose of this study is to compare the absorption of four different inhalation products with the reference product in healthy volunteers.

Healthy subjects will be enrolled and will receive single doses of 4 test inhalation products and one reference inhalation product according to a five-period cross-over design. Plasma tiotropium levels will be measured pre-dose and over 8 hours post-dose.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteer
* Willing and able to give informed consent
* Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic
* Subjects must agree to use an adequate method of contraception from admission through 12 weeks after last administration

Exclusion Criteria:

* Evidence or history of clinically significant abnormalities or disease or chronic respiratory disorders
* Any presence or history of a clinically significant allergy including any adverse reaction to study drug
* History of drug or alcohol abuse within the past 2 years
* Smoked tobacco within the past 6 months or have a history of more than 10- pack years (number of packs smoked per day x number of years smoked)
* Donation or loss of greater than 400 mL of blood within the previous 3 months
* Have received any prescription medication within 4 weeks or investigational medication within 12 weeks of study (exception: contraceptives are permitted)
* Have received any non-prescription medication within 14 days prior to dosing (exception: paracetamol use within 2 days)
* Upper respiratory tract infection (excluding otitis media) within 14 days of the first study day, or lower respiratory tract infection within the last 3 months
* If female, nursing, lactating or pregnant
* Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)

The IMRT-HIT-SNT trial is a prospective, mono-centric, phase II trial evaluating toxicity and efficacy in the combined treatment with intensity-modulated radiation therapy (IMRT) and carbon ion (C12) boost. Primary endpoint is mucositis ≥ CTC°3, secondary endpoints are local control, disease-free survival, overall survival, and toxicity. Planned accrual of the trial includes 36 patients with histologically proven (≥R1-resected or inoperable) sinonasal malignancies.

Local control in sinonasal malignancies is dose dependent. However, dose escalation at acceptable toxicity is technically demanding even with modern radiotherapy techniques. Raster-scanned carbon ion therapy with highly conformal dose distributions may allow higher doses at comparable or reduced side-effects.

Methods/ design:

The IMRT-HIT-SNT trial is a prospective, mono-centric, phase II trial evaluating toxicity in the combined treatment with intensity-modulated radiation therapy (IMRT) and carbon ion (C12) boost in 36 patients with histologically proven (≥R1-resected or inoperable) adeno-/ or squamous cell carcinoma of the nasal cavity or paransal sinuses. Patients receive 24 GyE carbon ions (8 fractions) and IMRT (2.0 Gy/ fraction).

Study objectives:

Incidence of mucositis ≥ CTC°3 will be assessed as the primary endpoint of the trial, local control, disease-free survival, overall survival, and toxicity (incl. mucositis CTC °I-II and late toxicity at 2 years post RT)are secondary endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed or surgically removed adenocarcinoma or squamous cell carcinoma of the nasal cavity or paranasal sinuses
* Inoperable tumour or refusal to undergo surgical resection
* Macroscopic or microscopic residual tumour (R2/ R1) or
* ≥T3/T4 or
* written informed consent
* pts aged 18 - 80 years
* effective contraception for pts in childbearing age (\<12 months post beginning of menopause)

Exclusion Criteria:

* Prior radio- or chemotherapy for tumours of the head and neck
* Other previous malignancy within the past 5 years except prior, adequately treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
* Significant neurological or psychiatric condition including dementia or seizures or other serious medical condition prohibiting the patient's participation in the trial by judgement of the investigators
* Legal incapacity or limited legal capacity
* Positive serum/ urine beta-HCG/ pregnancy
* Drug abuse
Respiratory Effects of Perioperative Oxygen During General Anaesthesia

Aim: To investigate the effect of high intra- and postoperative oxygen concentration (80%, as opposed to normally 30%) on pulmonary gas exchange and other pulmonary complications after abdominal surgery.

Background: Previous studies have shown possible beneficial effects of high perioperative oxygen concentration on surgical wound infection and healing, but all pulmonary effects are not clarified. Change in perioperative PaO2/FiO2 and shunt-fraction, measured by a gas rebreathing technique, can describe pulmonary oxygenation. This could add knowledge to the pulmonary effects of high vs. normal oxygen concentration.

Primary hypothesis of study: Perioperative use of a 80% oxygen concentration reduces the PaO2/FiO2-index compared to 30% oxygen.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Laparatomy, elective

Exclusion Criteria:

* Inability to give informed consent
* Chemotherapy within 3 months
* Other surgery within 30 days(except surgery in local anaesthesia)
* Inability to keep oxygen saturation above 90% without supplemental oxygen (measured preoperatively by pulse oximetry)
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)

This study is designed to evaluate the safety, tolerability, and immunogenicity of two different lots of V114 in healthy infants 6 to 12 weeks (\>=42 days to \<=90 days) of age. The primary hypothesis of the study is that the proportion of participants receiving V114 who have serotype specific IgG \>=0.35 mcg/mL for each of pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F at 1 month after Dose 3 is non-inferior to that for recipients of Prevnar 13™.


Eligibility Criteria:
Inclusion Criteria:

* Infant approximately 2 months of age (42 days to 90 days), inclusive
* In good health

Exclusion Criteria:

* Prior administration of any pneumococcal vaccine
* Known hypersensitivity to any component of the pneumococcal conjugate vaccine or any diphtheria toxoid-containing vaccine
* Known or suspected impairment of immunological function
* History of congenital or acquired immunodeficiency (eg, splenomegaly)
* Mother has documented human immunodeficiency virus (HIV) infection
* Mother has documented hepatitis B surface antigen-positive test result
* Known or history of functional or anatomic asplenia
* History of failure to thrive
* History of a coagulation disorder
* History of autoimmune disease
* Known neurologic or cognitive behavioral disorder
* Expects to require systemic corticosteroids within 30 days after each vaccination during the trial
* Prior administration of a blood transfusion or blood products, including immunoglobulin
* Participated in another clinical trial of an investigational product
* History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease
Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of ASC42 in Healthy Subjects

This is a first in human study of single and multiple ascending doses and food effect of ASC42.

This study consists of 8 cohorts and is divided as follows:

Part Ia: Single ascending doses study including cohorts 1 to 5. Part Ib: A cross-over design of cohort 2 to study the food effect on ASC42 PK. Part II: Multiple ascending doses study including cohorts 6 to 8.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy male and female subjects between 18 to 65 years of age.
* Subjects' weight ≥ 50 kg and BMI within the range of 19 - 29 kg/m2.
* Physical examination and vital signs are within normal range or slightly abnormal.

Key Exclusion Criteria:

* History or current liver disease, or liver injuries.
* A positive HBsAg, HCV Ab and/or HIV Ab.
* Platelet count \<150,000/mcL
* INR\> 1.2
Effect of Ciclesonide on Quality of Life in Patients With Moderate Persistent Asthma (21 to 65 y) (BY9010/AR-101)

The aim of the study is to compare the effect of ciclesonide on quality of life, pulmonary function and time to first exacerbation in patients with moderate persistent asthma. Ciclesonide will be administered once daily in the evening at two dose levels. The study duration consists of a baseline period (2 weeks) and a treatment period (8 weeks).


Eligibility Criteria:
Main Inclusion Criteria:

* Written informed consent
* Good health with the exception of asthma
* Clinical diagnosis of moderate persistent asthma during the last 6 months prior to visit B0
* Pre-treatment with inhaled corticosteroids dose equivalent to 250 - 500 mcg BDP / day at stable dosing during the last 4 weeks prior to visit B0, concomitant or not to short-acting beta2-agonists treatment as rescue medication
* FEV1 ≥ 70% and ≤ 90% predicted measured at least 4 h after the last use of rescue medication at visit B0
* Reversibility ≥ 12% and ≥ 200 mL in B0, B0 or T0, after inhalation of 400 mcg of salbutamol
* Patients compliant to recommended pre-treatment

Main Exclusion Criteria:

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
* Chronic obstructive pulmonary disease (COPD)
* Hospitalization within previous four weeks from baseline
* Hospitalization due to asthma within the last twelve months
* Asthma exacerbation within two months previous to baseline
* History of almost fatal asthma at any moment
* Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women
* Exacerbation of asthma within 2 months prior to entry into the baseline period
* Use of systemic steroids up to 2 months (injectable depot steroids 6 months) before entry into the baseline period, or more than 3 times during the last 6 months
Hematological Disorders in Covid 19 Patients

aim of the research is to detect hematological abnormalities in covid 19 patients and its correlation with the severity and outcome of the disease.

Covid 19 is an infectious disease caused by a newly discovered coronavirus.most people infected with the covid 19 virus will have mild to moderate respiratory illness and recover without specific treatment.older people and those with underlying medical problems like cardiac diseases,diabetes,any chronic respiratory disease and cancer are more likely to have serious illness.the covid 19 virus spreads primarily through droplets of saliva or discharge from the nose oral cavity when an infected person coughs or sneezes.people with covid19 have had a wide range of symptoms reported _ranging from mild to severe symptoms.symptoms may appear 2_14 days after exposure to the infection .any one can have mild to severe symptoms.people with these symptoms may have covid 19: fever or shivering,cough,shortness of breath,fatigue,body or muscle aches,headache,new loss of smell or taste ,sore thraot,congestion or running nose , nausea or vomiting,diarrhoea.

The most common hematological clinical findings include lymphocytopenia,neutrophilia,eosinophilia,mild thrombocytopenia,and less frequently thrombocytosis,the presence of reactive lymphocytes has been reported only occasionally the leucocyte count may be normal,reduced or increased.according to a meta analysis leucocytosis,lymphopenia and thrombocytopenia are associated with greater severity and fatality in covid 19 cases

Eligibility Criteria:
Inclusion Criteria:

all covid 19 patients diagnosed by pcr or CT chest

-

Exclusion Criteria:

* No
The Effect of Dexmedetomidine on the Emergence Agitation in Nasal Surgery

The investigators examined the effect of dexmedetomidine on the emergence agitation and postoperative quality of recovery in nasal surgery

Emergence agitation during the immediate postanesthetic period is common. It may lead to serious consequences for the patient, such as injury, increased pain, hemorrhage, self-extubation, and removal of catheters. Emergence agitation is common in ENT surgery. The aim of this study is to evaluate the effect of dexmedetomidine on the emergence agitation and postoperative quality of recovery in adult patients undergoing nasal surgery.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 20,
* ASA class I and II,
* nasal surgery

Exclusion Criteria:

* bradycardia (\< 45 bpm),
* heart block,
* liver failure,
* renal failure,
* uncontrolled hypertension,
* body mass index ≥ 30 kg/m2
Addition of Heparin to Taurolock-TM CLS in HD Patients With TCC Dose it Improve Catheter Patency Problems ?

Addition of Heparin to the Catheter Lock Solution (CLS): Taurolock-TM will improve the vascular patency compared to Taurolock-TM alone , in hemodialysis patients with Tunneled Cuffed Catheter(TCC) as vascular access.

Bacteremia and thrombosis are the major complications of TCC used for hemodialysis.Instilation of CLS containing antibiotic-anticoagulant solution in the end of each dialysis session till the next dialysis ,can prevent Catheter related bacteremia (CRB).In previous study in our department, Taurolock-TM decreased the rate of CRB but increased the incidence of catheter malfunction.

The aim of the study is to investigate the influence of of Heparin addition to CLS-Taurolock- TM ( Taurolidine \&citrate 4%) in prevention of catheter patency problems in HD patients with TCC, in addition to CRB prevention.

Methods : Patients with newly inserted TCC for HD enrolled and randomized to receive one of three CLS types : group 1- Taurolock-TM, Group 2 - Taurolock-TM and Heparin , Group 3- Heparin .Patients were followed for 6 monthes.

The objective of the study is to investigate the effect of Taurolock TM with heparin on the rate of CRB and vascular patency.

Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis patients with new TCC
* Informed Consent
The Effectiveness of Low Carbohydrate Diet in Reducing Polypharmacy for Patients With Type 2 Diabetes Mellitus

This study determines whether an educational intervention with a 90 g/day LCD is safe, effective and has good compliance for poorly controlled type 2 diabetes patients.

Poorly controlled type 2 diabetic men and women, aged between 20 and 80 years, with HbA1c≧ 7.5% (58mmol/mol) in the previous 3 months participated in this randomized controlled 18-month trial at a medical center. Patients were randomly assigned to the interventional group and given a 90g/day low carbohydrate diet (LCD) or the controlled group, which maintained a standard calorie-restricted diet (CRD). All patients received periodic educational intervention and were monitored for weight, body composition, waist girth, hip girth, thigh girth, pre- and post-prandial serum glucose, HbA1c, lipid profile(Cholesterol, Triglyceride. HDL, LDL, sdLDL), renal function, microalbumin/cre, carotid intima-media thickness (IMT),and medication effect score (MES).

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes diagnosis ≧ 1 year
* poorly controlled with HbA1c≧ 7.5% in the previous 3 months.
* aged 20 to 80
* without or with treatment \[ oral hypoglycemic agents (OHA) and/or insulin treatment)

Exclusion Criteria:

* pregnancy or lactating women
* impaired renal function with serum creatinine ≧ 1.5 mg/dl
* abnormal liver function \[alanine aminotransferase (ALT), aspartate aminotransferase (AST), ≧ 3 times the normal upper limit) or liver cirrhosis
* significant heart diseases (unstable angina, unstable heart failure)
* frequent gout attacks (≧ 3 times/year)
* participation in other weight loss programs or the use of weight-reducing drugs
* eating disorders
* could not complete the questionnaire
* poor compliance to protocol.
Promoting Co-Parenting and Reducing Hazardous Drinking in New Families

This study aims to understand if a parenting program that helps couples learn to parent as a team and maintain a healthy lifestyle, such as maintaining safer levels of alcohol use, promotes parent and child health and well-being. Programs will be delivered prenatally and postnatally and will include both group classes and individualized sessions. A comprehensive assessment is administered during pregnancy and then at 6 and 12 months of child age. It is hypothesized that targeting intervention during the naturally motivating transition to parenthood may not only provide opportunities for long lasting behavioral change for parents, but also initiate a cascade of protective processes that ultimately reduce risk for negative emotional and behavioral outcomes for children.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant couples who are cohabitating
* Parents are 18 years of age or older
* Health behavior such as moderate to heavy drinking
* English speaking

Exclusion Criteria:

* Plural pregnancy
* Illicit drug use other than cannabis for either parent
Efficacy of Virtual Reality Exposure Therapy Scripts for Social Phobia

The purpose of this study is to test the efficacy virtual reality videos to facilitate exposure therapy in social anxiety disorder (SAD). The exposure therapy videos are the focus of this experiment. Essentially, we are testing the efficacy of the Virtual Reality Exposure Therapy (VRET) scripts (i.e., virtual scenarios, people, and interactions that we expose socially anxious people to). To this end, the goal of the current study is to help people with social anxiety overcome their phobias. Individuals who experience a difficult time building social relationships, accomplishing everyday tasks, or pursuing job interviews can practice those same behaviors in a controlled environment. Specifically, we aim to test the following hypotheses: (1) Virtual reality exposure therapy intervention (vs. waitlist control condition) is effective for treating SAD symptoms. (2) Participants who received the VRET will experience maintenance of treatment gains following 3-month and 6-month post-termination of treatment. (3) Users of the virtual reality exposure therapy will demonstrate high amounts of acceptability of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Presence of Social Anxiety Disorder based on the Social Phobia Diagnostic Questionnaire self-report or Mini International Neuropsychiatric Interview
* Current student at the Pennsylvania State University or a community-dwelling adult who expressed interest to participate through the PSU StudyFinder portal
* Expressed interest to seek treatment
* Currently not receiving treatment from a mental health professional
* Able to provide consent
* Proficient in English

Exclusion Criteria:

* Below age 18
* Failure to meet any of above inclusion criteria
* Presence of suicidality, mania, psychosis, or substance use disorders