cyrilzakka/clinical-trials huggingface dataset:
Family-Centered Behavioral Preparation for Surgery

Children experience significant anxiety and distress during the preoperative period. Currently available interventions are ineffective and/or associated with significant disadvantages. These interventions exclusively target the child and do not attempt to reduce parental anxiety. Based on an integration of the literature in both the anesthesia and psychological milieus, we developed ADVANCE, a behaviorally oriented anxiety reduction program for children undergoing surgery that targets the family as a whole.

Children and their parents (n=408) were randomly assigned to one of four groups: 1) Control: received standard of care, 2) PPIA: received standard parental presence during induction of anesthesia, 3) ADVANCE: received family-centered behavioral preparation, and 4) oral Midazolam. We assessed the effect of group assignment on anxiety levels and postoperative outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Children 2-10 years old who were in good health (American Society of Anesthesiology physical status I-II) and who were undergoing general anesthesia and elective, outpatient surgery, and their parents.

Exclusion Criteria:

* Children with a history of chronic illness, prematurity (fewer than 36 weeks gestation) or reported developmental delay
Shanghai Mild Cognitive Impairment Cohort Study

This study was planned 1) to identify individuals with Mild Cognitive Impairment (MCI) who convert to Alzheimer's Disease (AD), and 2) to explore factors associated with the conversion.


Eligibility Criteria:
Inclusion Criteria:

1. Cognitive concern reflecting a change in cognition reported by the patient or informant or clinician
2. Mini-Mental State Examination (MMSE) scores between 18-30 (inclusive)
3. Clinical Dementia Rating (CDR) =0.5; Memory Box score must be at least 0.5
4. Objective memory loss\* as evidenced by Auditory Verbal Learning test (AVLT-HS)
5. Essentially preserved activities of daily living based on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
6. Not-demented, as defined by '"All-cause Dementia" (see 3.4. All-cause Dementia)
7. Willing to and able to undergo all test procedures including neuroimaging, and agree to longitudinal follow up
8. Written informed consent for the participation of this study including repeated neuropsychological tests and MRI scans
Open Label Study to Evaluate Effect, Safety and Tolerability of Betaferon Standard Dose of 250µg in Patients of Chinese Origin With Multiple Sclerosis

The purpose of this study is to determine if the study drug is effective and safe in the treatment of Multiple Sclerosis (MS) in patients of Chinese origin.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany.

Bayer HealthCare AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Chinese origin
* diagnosis of Relapsing remitting multiple sclerosis or secondary progressive multiple sclerosis

Exclusion Criteria:

* Any disease other than Multiple Sclerosis (MS) that could better explain the patients signs and symptoms
* HIV (human immunodeficiency virus) infections
* Hepatitis A
* Syphilis
* immunodeficiency
* rheumatic disease or Sjogren syndrome
* heart disease
* severe depression
* pregnancy or lactation
* conditions interfering with Magnetic Resonance Imaging (MRI)
* Gadolinium DTPA (Gadovist, contrast agent) allergy
* allergy against human proteins, paracetamol, acetaminophen and ibuprofen intolerance
* participation in other trial
Re-Rehabilitation in Chronic Obstrctive Pulmonary Disease

Patients with COPD who participated in the second rehabilitation program in the Pulmonary Rehabilitation unit will be included in the study. Pulmonary function tests, arterial blood gases, mMRC dyspnea perception, 6-minute walking distance, disease-specific (SGRQ) quality of life and hospital anxiety depression scale values will be compared.

Pulmonary rehabilitation (PR) program in patients with COPD reduces dyspnea perception, increases exercise capacity, improves quality of life, and reduces psychological symptoms. Unfortunately, these gains are not permanent, but disappear within 12-24 months. The aim of this study is to compare the gains of the second PR program with the first program.

Patients with COPD who participated in the second rehabilitation program in the Pulmonary Rehabilitation unit will be included in the study. Pulmonary function tests, arterial blood gases, mMRC dyspnea perception, 6-minute walking distance, disease-specific (SGRQ) quality of life and hospital anxiety depression scale values will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years
* Completed PR program

Exclusion Criteria:

-
Driving Ability Evaluation System to Improve the Conditional Driving License System: Feasibility Study of High-risk Drivers.

The primary objective of this study is to verify the safety and validity of a VR driving simulator developed for evaluating the driving abilities of elderly drivers.

This study also aims to establish indicators in VR driving simulator to evaluate high-risk group for driving, such as cognitive and physical abilities. Therefore, this study aims to measure the physical driving function, general physical function and cognitive function of elderly drivers. to identify the correlation between their outcomes and the VR driving simulator's result

VR driving simulator is to evaluate the driving abilities of high-risk drivers, including the elderly and those with medical conditions, potentially prone to incapacitate driving.

It aims to evaluate whether drivers who were anticipated to have impaired driving ability can handle highly risky situations for traffic accidents. The results of this study can be used to make the drivers know their status and encourage them to take safety training. Until now, the evaluation of driving abilities could only be conducted at licensing centers. However, the use of VR technology can eliminate spatial limitations, offering a promising tool for the objective assessment of driving skills.

Eligibility Criteria:
Inclusion Criteria:

* Individuals over the age of 65 who are currently driving.
* Individuals capable of understanding and following the researcher's instructions.
* Individuals who can understand the purpose of the research and have consented to participate

Exclusion Criteria:

* Those who have not signed the consent form.
* Individuals with a history of severe dizziness or epilepsy.
* Patients with restrictions on sitting in a wheelchair or chair for more than 30 minutes.
* Patients with severe shoulder pain.
* Patients whose range of motion in major joints is restricted by more than 50%.
* Pregnant women.
* Patients with pressure sores.
* Patients with limitations on simulator use due to heterotopic ossification.
* Patients with acute fractures.
* Other patients for whom participation in the study is expected difficult.
ATHNdataset Registry

The Hemophilia Treatment Center (HTC) where you receive care is working with The American Thrombosis and Hemostasis Network (ATHN) to look at the quality of life of people with blood disorders and problems.

Doctors, scientists, policymakers, and other health care providers need a large amount of information from a lot of people to answer scientific, public health, and policy questions about better ways to treat blood disorders. They will use the information from the ATHNdataset to answer these questions.

Participants who agree to participate will let their health information be included in the ATHNdataset Registry, and the information will be updated regularly to reflect the participant's current health status. This registry includes collecting, storing and managing health information through a secure database. The following health information will be collected:

* Demographics (e.g., age, gender, income, education/occupation)
* The type of blood disorder you have
* Date you were diagnosed, or symptoms began
* Family history of the disorder
* Testing and assessments
* Physical exams
* Height, weight
* Vital signs, including blood pressure and heart rate
* Laboratory tests (results from blood or urine testing, or biological specimens)
* Genetic test results
* Imaging results (X-rays, CT scans, etc.)
* Pharmacokinetic testing results (how drugs are processed in the body)
* Medications used and any problems with use
* Types of bleeds, pain and clotting problems
* Treatments that stop your bleeding or clotting problems from occurring or getting worse
* Surgeries and/or procedures
* Immunizations (vaccines)
* Devices
* Routine care visits and injuries (trauma)
* Other illnesses and diseases you may have
* Allergies
* Patient-reported outcomes (PROs), questionnaires, and surveys
* Payment details for treatment, including insurance companies and health plans

Eligibility Criteria:
Inclusion Criteria:

* Any participant evaluated for or the potential to have a blood disorder who has an encounter with an ATHN Affiliate.
* Participants of any age.
* Participant is able to provide consent or assent; a Legally Authorized Representative (LAR) may provide consent on a participant's behalf if a participant is unable to provide self-consent

Exclusion Criteria:

* Any participant unable to provide consent or assent to participate in the ATHNdataset
Video Laryngoscopy vs Direct Laryngoscopy in Paediatric Patients

The goal of this interventional study is to compare the effectiveness of direct laryngoscopy vs. video laryngoscopy in paediatric population aged 2 to 8 years presenting for elective surgeries having uncomplicated airways.

The primary outcome measures include:

1. Time taken for succesful insertion and confirmation of ETT in patients using both techniques seprately.
2. Rate of complications and failed attempts compared between both modalities.

The comparision of efficacy of Video Laryngoscopy for pediatric airway vs Direct Laryngoscopy is the goal of this study, Safety of the patients will be the utmost priority with careful case selection alongwith proper informed detailed consent from the guardians of the children.

PROCEDURE:

After induction of General Anesthesia four minutes of proper bag mask ventilation to allow for proper intubating conditions will be done. The time taken from the insertion of the laryngoscopic blade to the best glottic view acheived by the specific technique will be noted seperately and then the time to the succesful acheivement of lung inflation with the proper placement of ETT will be noted seperately, both of these parameters will be recorded.

If in a patient airway is not secured even after 3 attempts by a specific technique the technique would be altered and patient would be excluded from our research.

MATERIALS:

Randomized allotment of patients into the 2 groups i.e Direct Laryngoscopy and Video Laryngoscopy would be done.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients of age between 2 - 8 years,
* American Society of Anesthesiologist (ASA) grades I-II Children
* Cormack-Lehane grade I, II and III who will need airway management for elective surgery under general anesthesia.

Exclusion Criteria:

* Patients with abnormal airway anatomy,
* Obese patients,
* Emergency surgery,
* Congenital syndrome involving any major organs
* Patients' guardians unwilling to participate .
* Patients in whom airway is not secured with a specific technique even after three attempts.
Determination of Blood Loss After CS

Comparing betweeen tranexamic acid plus oxytocin and oxytocin alone in their efficacy in reducing blood loss following CS

tranexamic acid plus oxytocin versus oxytocin only in reducing blood loss following CS

Eligibility Criteria:
Inclusion Criteria:

1. Age : 20-40 year

   * 2- Gestational age is between 37-41weeks

3- Delivery by uncomplicated elective CS

Exclusion Criteria:

* 1- Risk factors for uterine atony such as polyhydramnios or fetal macrosomia. 2- Grandmultiparity 3- Past history of postpartum hemorrhage either atonic or traumatic 4- Previous history of retained placenta 5- Pre-eclampsia or gestational hypertension/ Maternal DM 6- Abnormal placentation 7- Contraindications to the use of tranexamic acid 8- Hypersensitivity to tranexamic acid. 9- Women receiving anticoagulant therapy. 10- having underlying disease (heart, liver, kidney, pulmonary, etc.),
Bacterial Properties With LoFric® Catheters During Clean Intermittent Catheterization

The primary objective of our study is to examine characteristics of bacteria that are discovered in urine from pediatric patients that utilize either LoFric® or non-LoFric® catheters for self intermittent catheterization. The investigators hypothesize that the hydrophilic nature of the LoFric® catheter will alter the microbial environment and reduce clinically significant urinary tract infections in patients with neurogenic bladder compared to a similar population using standard catheters.

Secondary outcomes will be comparing the incidence of clinical urinary tract infections between patients that use standard catheters and those that use LoFric catheters.

Lastly, patient satisfaction using LoFric catheters compared to standard catheters will be assessed.

The investigators will randomize patients with neurogenic bladder into 2 groups after the have been matched for age, gender and mobility.

The first group will continue with their current intermittent catheterization system (a non-LoFric® catheter) while the second group will receive sufficient LoFric® catheters to complete the study. The investigators will collect the urine at the start of the study, and then at 3, 6, 12, and 18 months and sent for culture. If a child develops a urinary tract infection, the investigators will have the patient collect the urine and the urine will be cultured and the organism will be identified.

Using an existing bladder cell line, the investigators will inoculate the bladder cells with any bacteria that grows from any sample and then determine the interleukin-6 response of the bladder cell line following inoculation with the bacteria. This will determine if the initiate a high or low cytokine response which the investigators have correlated to clinical risk of symptomatic urinary tract infection

The investigators will provide a patient satisfaction survey at the start of the study, prior to randomization and at the completion of the study to determine satisfaction with LoFric® catheters.

Eligibility Criteria:
Inclusion Criteria:

* Patients who perform clean intermittent catheterization on a regular basis

Exclusion Criteria:

* Patients on daily continuous antibiotic therapy
Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia

The purpose of this study was to determine the safety and effectiveness of different doses of botulinum toxin Type A in treating lower urinary tract symptoms due to benign prostatic hyperplasia.


Eligibility Criteria:
Inclusion Criteria:

* Lower urinary tract symptoms due to benign prostatic hyperplasia
* Enlarged prostate volume by rectal ultrasound

Exclusion Criteria:

* Previous prostate surgery
* Previous or current diagnosis of prostate cancer
* Use of other medications for the treatment of prostatic hyperplasia
* Urinary tract infection
Percutaneous Ethanol Injection for Primary Papillary Thyroid Microcarcinoma

We assess the effectiveness of percutaneous ethanol ablation for the treatment of thyroid cancer.

We hypothesize that percutaneous ethanol ablation (PEA) for primary papillary thyroid microcarcinoma (PTMC) has equivalent oncologic outcomes to current treatment options including observation, thyroid lobectomy and total thyroidectomy. In addition, we hypothesize that it will yield superior long-term quality of life, including measures of pain, voice, and cosmesis than standard surgical therapy (total thyroidectomy). If our hypotheses are correct, the findings of this study have the potential to fundamentally change clinical management of this group of patients.

This study was changed from its initial design: a 2 arm study comparing PEA to surgery (Amended April 30, 2015). The change in design was made based on several discussions within Yale Endocrine Surgery, with patients diagnosed with PTMC, and knowledge of other institutions performing PEA for PTMC as standard of care.

The study team had been contacted by numerous potential subjects interested in PEA who were unwilling to be randomized to surgery. Because patients interested in PEA appeared to be firmly against the idea of thyroidectomy, we believed that we would be unable to enroll sufficient patients to this study as the protocol originally stood.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Diagnosis: single, cytology-proven papillary thyroid carcinoma measuring 1 cm or less in diameter (microcarcinoma, T1a), without visible extrathyroidal extension, and with negative central and lateral neck lymph nodes by ultrasound

Exclusion Criteria:

* Patient refusal to participate
* History of prior thyroid or parathyroid surgery
* Previous recurrent laryngeal nerve injury
* Inability to make decisions or comply with follow up
* Co-existing indication for thyroidectomy
* Aggressive cytological or molecular features
* Multifocal papillary thyroid carcinoma
* Pregnant or breast-feeding
* Anatomically unfavorable location of the tumor (proximity to recurrent laryngeal nerve or trachea)
* Documented or suspected distant metastasis
* History of radiation to neck or face
* Family history of thyroid cancer
Induction Immunochemotherapy in Stage III-IVa Head and Neck Cancer

patients with locally advanced cancer of oropharynx, hypopharynx or larynx and CPS\>1 will recieve 3 cycles of induction immunochemotherapy with platinum, 5-FU and pembrolizumab followed by (chemo)radiation.

patients with locally advanced cancer of oropharynx, hypopharynx or larynx and CPS\>1 will recieve 3 cycles of induction immunochemotherapy with platinum (cisplatin 75 mg\\m2, 5-FU 1000 mg/m2/day 96-hour infusion and pembrolizumab 200 mg) followed by (chemo)radiation. Effect of induction therapy will be assesed by PET/CT and by endoscopic evaluation with biopsy of suspected residual tumor. Managemant of any residual tumor will be performed according with local rules and standards.

Eligibility Criteria:
Inclusion Criteria:

* Squamous cell cancer of oropharynx (p16+: T0-3N3, T4N0-3, p16- : T3-4aN0-1, T1-4aN2-3), hypopharynx (T2-3N0-3, T1N+, T4aN0-3) or larynx III-IVa (T1-2N2-3, T3N2-3, T4aN0-3) , TNM8 staging classification;
* Tumor is morphlogically confirmed;
* CPS\>1 (22C3 clone);
* ECOG 0-2;
* Age above 18 years;
* Signed Informed consent form.

Exclusion Criteria:

* Cancer of nasopharynx;
* Non-squamous cell carcimomas or absense of morphological confirmation of squamous cell cancer;
* Stages I or II;
* ECOG\>=3.
Utility of CAML as Diagnostic for Early Stage Lung Cancer

Primary Objective Determine the prevalence of CAMLS in patients with pulmonary nodules.

Secondary Objectives Determine the positive and negative predictive value of CAMLS in patients with pulmonary nodules who undergo biopsy.

Model combinations of clinical factors with the presence/absence of CAMLS to refine strategies for assessment of patients with pulmonary nodules. Evaluate whether these measures result in enhanced T-cell activity and/or NK cell function and number


Eligibility Criteria:
Inclusion Criteria:

* Referral for a pulmonary nodule that has not yet been biopsied and that meets the definition of an "indeterminate" nodules (i.e. 0.8-3.0 cm).
* No prior diagnosis of lung cancer or other invasive malignancy within the past 5 years.
* No history of rheumatologic disease.
* Age \> 18 years.
* Ability to understand and willingness to sign a written informed consent and HIPAA consent document

Exclusion Criteria:

* Patients with active, known or suspected autoimmune disease.
* Prior diagnosis of lung cancer or other invasive malignancy within the past 5 years.
* Uncontrolled intercurrent illness that would increase the risk of toxicity or limit compliance with study requirements. This includes but is not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Known HIV-positive patients on combination antiretroviral therapy are ineligible because of the abnormal immune response that results from HIV disease (testing is not required).
* Patients should be excluded if they are known to be positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection (testing is not required).
* Subjects with any history of interstitial lung disease or a history of \> or = to grade 2 radiation pneumonitis.
Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia

To assess the effectiveness of aripiprazole once-monthly in the maintenance treatment of patients with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR®), in a naturalistic care setting by comparing it to an existing long-acting antipsychotic, paliperidone palmitate.


Eligibility Criteria:
Main Inclusion Criteria:

* The patient has schizophrenia, diagnosed according to DSM-IV-TR®.
* The patient has a CGI-S score from mildly ill to markedly ill at the Screening and Baseline Visit(s).
* The patient is in need of a change in the current antipsychotic treatment and in the judgement of the investigator the patient would benefit from an extended treatment with a once-monthly formulation.
* The patient agrees to protocol-defined use of effective contraception.

Main Exclusion Criteria:

* The patient has any current psychiatric disorder or Axis I disorder (DSM-IV® criteria) other than schizophrenia established as the primary diagnosis.
* The patient is experiencing acute exacerbation of psychotic symptoms at the Screening Visit or between the Screening and Baseline Visits.
* The patient in the investigator's judgment has shown significant intolerance and/or lack of efficacy to oral aripiprazole, paliperidone or risperidone.
* The patient is at significant risk of harming himself/herself or others according to the investigator's judgement or according to Columbia-Suicide Severity Rating Scale (C-SSRS).
* The patient has a history of neuroleptic malignant syndrome.
* The patient has or has had significant medical condition that would expose him or her to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the study including, but not limited to neurological, hepatic, renal, metabolic, haematological, immunological, gastrointestinal, pulmonary, or cardiovascular disorders.
* The patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
* The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.