cyrilzakka/clinical-trials huggingface dataset:
Observational Surveillance Study to Detect Potential Safety Signals in Patients Who Have Had at Least One Dose of GARDASIL™ (V501-031)

This is a post-licensure safety surveillance program to detect potential safety signals in subjects, from the managed care organizations database, who have used GARDASIL™.


Eligibility Criteria:
Inclusion Criteria:

3-Dose Safety Population

* Female 9-26 years at the time of first dose of GARDASIL™
* Completed the 3-dose regimen of GARDASIL™ per protocol

Pregnancy Safety Population

* Received at least one dose of GARDASIL™ up to 30 days prior to the date of conception or any time between conception and the day of pregnancy resolution

Autoimmune Safety Population

* Female who has received at least one dose of GARDASIL™
* Has been a member of same Managed Care Organization (MCO) for at least 12 months prior to the receipt of GARDASIL™

Any Dose Safety Population

* Female who has received at least one dose of GARDASIL™

Exclusion Criteria:

3-Dose Safety Population

* Male
* Receives incomplete regimen of GARDASIL™
* Completes the three dose regimen of GARDASIL™ in more than 12 months
* Less than 28 day interval between doses 1 and 2 or less than a 12 week interval between doses 2 and 3
* Younger than 9 or older than 26 years of age at receipt of first dose

Pregnancy Safety Population

* Males
* No record of pregnancy at the Managed Care Organization (MCO)

Autoimmune Safety Population

* Member of the same MCO for less than 12 months prior to receiving the first dose
* Male
To Assess Breathing Exercise as a Relaxation Method

in this study investigator evaluate the effectiveness of breathing exercise using two different play toys in reducing dental anxiety.

bubble blower and pin wheel are used to facilitate breathing exercise and to reduce dental anxiety hence more cooperation of participants during dental treatment

Eligibility Criteria:
Inclusion Criteria:

* children that had been introduced to dental setting without receiving any dental treatment
* According to Corah 's dental anxiety scale children classified with score 19 or more
* No learning disability or psychological disorder or parental anxiety

Exclusion Criteria:

* children in emergency visit
* Allergy to anesthetic drugs
* Use of analgesic before treatment
* Teeth with necrotic pulp
* children whose parents refused to sign informed consent
Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events

The goal of this study is to test the feasibility and acceptability of an informational website to reduce uncertainty, psychological distress, and caregiver burden among close family members of cardiac arrest patients. The investigators hypothesize that participants who receive access to the website will have lower rates of uncertainty, psychological distress, and caregiver burden at 3 months post-hospital discharge compared to participants who receive usual care.

This study will be an unblinded, two-arm randomized controlled trial that enrolls up to 100 adult surrogates of living cardiac arrest patients hospitalized in the New York Presbyterian hospital system. Participants must be English- or Spanish-speaking and have a device with internet access. Participants will be randomized 2:1 to receive the informational intervention program or usual care (control).

Intervention arm participants will receive the informational intervention in three discrete packages upon study enrollment, movement to the general medical floor, and at one month post-discharge. All participants will be assessed at study enrollment, hospital discharge, and 3 months post-discharge for their illness uncertainty, psychological distress, and caregiver burden. All participants will also wear a GENEActiv sleep monitor to track their sleep for one week following hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Surrogate of a living NewYork Presbyterian Hospital cardiac arrest patient
* English- or Spanish-speaking
* Has a working smartphone, tablet, laptop, or other device with internet access

Exclusion Criteria:

* Any medical and/or psychiatric impairment precluding them from complying with the protocol
* Non-English and non-Spanish speaking
* Lack of internet/device access
* Surrogate of an adult CA patient who passed away
* Cannot be reached for initial contact (3 unsuccessful attempts made in ICU)
* Moved to the in-patient floor before initial contact can be established
The Impact of Vitamin on the Clinical Course in Cases Infected by Novel H1N1 Influenza Virus A

Influenza continues to inflict an important burden on health-care systems. The 2009 H1N1 influenza virus first appeared in Mexico and the United States in March and April 2009 and has swept the globe with unprecedented speed.

The aim of this study is to evaluate effect of supplement vitamin on the clinical course of patients with acute respiratory illness suspected novel H1N1 infection.

Patients with acute respiratory illness randomized to control or vitamin groups. The patients completed questionnaire about their initial symptom scores. After 5 days of vitamin trial, patients were asked about their symptom by telephone survey.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 20 years
* Acute respiratory illness suspected H1N1 infection
* Acute febrile respiratory illness(BT \> 37.8) and throat pain or cough or nasal congestion

Exclusion Criteria:

* Pregnancy
* Hypersensitivity to vitamin A
* History of liver disease or renal disease
* Urinary stone disease
A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)

The purpose of this study is to evaluate the safety and efficacy of two parsaclisib treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL) who are naive to or were previously treated with a Bruton's tyrosine kinase (BTK) inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, aged 18 or older (except in South Korea, aged 19 or older).
* Histologically confirmed marginal zone lymphoma, including extranodal, nodal, and splenic subtypes.
* Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures \> 1.5 cm in the longest transverse diameter and ≥ 1.0 cm in the longest perpendicular diameter.
* Participants with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed.
* Participants must be willing to undergo an incisional or excisional lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
* Eastern Cooperative Oncology Group performance status 0 to 2.

Exclusion Criteria:

* Evidence of diffuse large B-cell transformation.
* History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
* Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K inhibitor.
* Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment.
* Active graft versus host disease.
* Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.
Vaginal Flora for Treatment of Bacterial Vaginosis

Bacterial vaginosis (BV) is the most common vaginal infection in women. It is caused by a vaginal bacterial imbalance. Treatment with antibiotics is the standard of care but there is a high rate of recurrence. Almost half of women successfully treated suffer a recurrence within three months. Complications include risk factors for premature birth, increased transmission of sexually transmitted diseases and higher risk for carcinoma of cervix. The investigators proposed study is a cost effective treatment based on returning the normal microbial balance to the vagina. The investigators propose to transfer normal vaginal flora from healthy individuals to women with BV and thus restore normal vaginal flora and cure this disorder.


Eligibility Criteria:
Inclusion Criteria:

* recurrent BV (4 or more incidences in the past year)
* recurrence of BV in less than 2 months of antibiotic treatment or need for prophylactic antibiotic
* 3/4 Amsel criteria and Nugent criteria greater or equal to 7

Exclusion Criteria:

* pregnancy or planned pregnancy during the study period
* other known diseases
* carriers of Hep B and C
* HIV or syphilis positive
Clinical Validation Study for iVue

To demonstrate clinical substantial equivalence of iVue as comparable to commercially available RTVue.


Eligibility Criteria:
Inclusion Criteria:

* Normal: Normal results from clinical exam and free of ocular pathology.
* Glaucoma: Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma.
* Cornea: Clinical exam results consistent with cornea pathology.
* Retina: Clinical exam results consistent with retina pathology
Effect of Graston Technique Versus MET on Improving Hamstring Flexibility and ADLS in Knee Osteoarthritis

The objective of this study is to determine the comparison of Graston technique versus muscle energy technique to improve hamstring flexibility and ADL among patient of knee O.A.


Eligibility Criteria:
Inclusion Criteria:

* Knee osteoarthritis patient with bilateral (but tested only severe side) or unilateral limb involvement.(13)
* Knee osteoarthritis patient already diagnosed by orthopedic surgeon with x ray findings showing grade I or II in kellgren and Lawrence criteria for knee OA will be selected. (16)
* Ambulate independently with or without assistive devices and ascend and descend at least a flight of stairs.(13)
* Both male and female will be included in study.
* Age above 40 to 55years.(13)

Exclusion Criteria:

* Patient with history of any known neurological, cardio or respiratory conditions.
* Patient present with history of open wound, Skin infection or tumors in the area of treatment.
* Any other orthopedic condition or fracture in the area of treatment limb.
* Patient will be excluded if they have low back pain, sciatica or deformities related to his spine and knee.
* Patient with history of recent lower limb or spinal surgeries.
The Impact of Charge Displays on Inpatient Laboratory Test Ordering

This is a clinical trial to evaluate the impact of presenting medicare fee data for inpatient laboratory tests in the electronic health record on provider ordering behavior at a tertiary care hospital.

This study is a clinical trial to determine the impact on inpatient laboratory test ordering of presenting providers with medicare fee data at the time of order entry. We will randomly assign 60 laboratory tests to an active arm (medicare fee data displayed) or to a control arm (medicare fee data not displayed). The primary outcome will be the change in the ratio of tests ordered per patient day over 12 months by study group (intervention vs. control).

Eligibility Criteria:
Inclusion Criteria:

* Not applicable

Exclusion Criteria:

* Not applicable
Analysis of Balance and Mobility for Parkinson Disease After Whole Body Vibration

Parkinson's disease has innumerous motor symptoms that impacting on the functional level of the patient, such as impairment in functional mobility and balance . Previous studies have already aimed to evaluate the effectiveness of whole body vibration, but without methodological criteria. The use of whole body vibration may be an alternative for the treatment of Parkinson's disease. Therefore, the objective of the study is to verify which frequency of vibration is able to improve the balance and mobility of patients with Parkinson's disease.

After confirming the eligibility criteria, patients will be asked to sign the informed consent form. Subsequently, they will be randomly allocated to three groups: (i) group 6 Hz: full body vibration (frequency 6 Hz, amplitude 4 mm, five cycles lasting 1 minutes and interval between cycles of 1 minute) , (ii) 25 Hz group: full body vibration (25 Hz frequency, 4 mm amplitude, five cycles lasting 1 minute and interval between 1 minute cycles) and (iii) sham group: The sham vibration will be performed with the platform disconnected. Additionally, a sound device will be connected producing a noise similar to that of the connected platform for a time equivalent to that of the treatment protocol. The patient will be instructed to position himself standing on the platform, with a semi knee flexion in order that the vibration wave does not propagate to the head. The allocation will be made randomly among individuals, using a random sequence table generated by the website www.randomization.com. There will be a washout time of at least one week between one intervention and another. All evaluations took place inside the laboratory, which has all the equipment for the evaluation. The evaluations will take place immediately before the intervention and immediately after.

Eligibility Criteria:
Inclusion Criteria:

* · Minimum score of the Montreal Cognitive Assessment (MoCA) (27 points);

  * Regular antiparkinsonian pharmacological treatment;
  * Staged from I to III on the modified Hoehn \& Yahr scale.

Exclusion Criteria:

* · Individuals with other neurological disorders, postural hypotension, vestibular, visual, cardiovascular or musculoskeletal disorders that affect the performance of the proposed tests;

  * other associated neurological disease
  * changes in medication in use for Parkinson's disease for at least sixty days before the start of the study
Comparison of Postoperative Analgesic Effectiveness of Superficial and Deep Serratus Plane Blocks for Mastectomy

Pain after breast surgery can be quite severe and can significantly affect quality of life. By successfully treating acute pain, it is aimed to prevent the formation of pain memory and to ensure that chronic pain never occurs. It is known that by using regional techniques, the use of general anesthetics and opioids can be reduced and their harmful effects can be limited. In this study, it will be compared the analgesic effectiveness of superficial and deep serratus plane blocks in the postoperative acute and chronic periods.

Acute and chronic pain is a serious problem in patients undergoing breast surgery. Apart from the feeling of pain, it also causes psychological difficulties, increased hospital stays, delays or difficulties in mobilization, and so on. Due to all these reasons, postoperative pain control is very important.

Although opioids are the gold standard in the treatment of pain, their side effect profiles (sedation, respiratory depression, constipation, tolerance development, etc.) limit their use and different searches are on the agenda. There are studies showing that superficial and deep serratus plane blocks are effective in mastectomy operations. In this study, patients who underwent mastectomy these two blocks will be compared to see which one is superior and to investigate the differences that may occur in the acute and chronic periods.

After general anesthesia induction, a superficial serratus plane block will be performed on the first group of patients undergoing surgery by applying local anesthetic to the fascia between the serratus anterior and latissimus dorsi muscles at the level of the 4th and 5th ribs under ultrasound. then the patient will undergo surgical procedure. Likewise, for the second group of patients, after general anesthesia induction, a deep serratus plane block will be performed by applying local anesthetic between the rib and the serratus anterior muscle at the level of the 4th and 5th ribs, under ultrasound guidance, and the patient will be taken into surgery. Both groups of patients will be monitored for 24 hours after the operation with a patient-controlled analgesia device. Patients' pain scores, satisfaction scores, nausea and vomiting scores, and additional analgesic needs will be recorded 24 hours postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* patients who will undergo mastectomy surgery
* patients who agreed to participate in the study
* ASA I-II patients

Exclusion Criteria:

* Patients planned for bilateral breast surgery
* Patients who have had previous breast surgery
* Patients with existing neuropathic pain or receiving treatment for neuropathic pain
* Patients with psychiatric disorders
* Patients with opioid addiction
* Patients allergic to local anesthetics
Children's Mercy Teens with Type 1 Diabetes Will Participate in an Online Peer Support Group.

The goal of this observational study is to examine the impact of an online peer support group in Children's Mercy teens with Type 1 Diabetes.

The main objectives are to examine the feasibility and acceptability of the Diabetes Link's online social platform Discord among youth with diabetes as it relates to peer support, diabetes management, and usability and to examine the efficacy/magnitude of the effect of the Discord group on treatment adherence among youth with diabetes.

Participants will participate in an online peer support group for 3 months and provide their feedback while doing so.


Eligibility Criteria:
Inclusion Criteria:

* T1D Diagnosis
* 16-19 years old
* 11th-12th graders
* Access to smartphone/laptop
* English-speaking
Pleuropulmonary Ultrasound With Clinical Examination to Check the Good Position of the Double Lumen Tube Intubation

Using a new ultrasound approach, allow us to avoid the systematic use of bronchoscopy which is an invasive procedure. Although rare, several complications are known with, among other things, the occurrence of pulmonary infections, pneumothorax associated with increased pressure in the airways, atelectasis or bronchospasm.

Avoid the systematic control by fibroscopy in simple cases which makes it possible to overcome the complications related to its use and its cost.

The investigators want to evaluate the diagnostic value of the echographic strategy in 2 steps (2D and TM) on 3 sections (pulmonary field on the axillary line of the 2 sides and left upper lobe) associated with the clinical examination in preoperative by comparing with the gold standard: fibroscopy. Clinical examination and pleuropulmonary ultrasound should have a positive predictive value of at least 85%.

In thoracic surgery, it is common to use selective intubation probes to exclude from ventilation the lung operated by the surgeon. It is recommended to perform a bronchoscopy which is the reference examination to confirm the good position of these probes. The interest of systematically controlling the good position of the left selective intubation probe by fibroscopy is controversial.

The interest of ultrasound for the diagnosis of pleuro-pulmonary pathologies is certain in resuscitation and emergency context for the diagnosis of pneumothorax, haemothorax and atelectasis.

The use of pleuropulmonary ultrasound in anesthesiology is the subject of studies. Several teams used it to ensure proper endotracheal tube positioning and to diagnose selective intubation. In fact, it has been shown that to control the position of the probe more precisely, ultrasound is more efficient than auscultation.

The aim of this work is to show by a large-scale prospective study that pleuropulmonary ultrasound associated with the clinical examination confirms the exclusion of the operated lung. the absence of systematic control of the positioning of the probe by fibroscopy allow financial gain and a reduction in the risk of morbidity related to the realization of this invasive gesture.

Eligibility Criteria:
Inclusion Criteria:

* Patient will benefit from thoracic or cardiac surgery requiring selective left intubation.
* Affiliation to the French social security

Exclusion Criteria:

* Minor patients
* Refusal of the patient
* Patients under guardianship, curators.
* Surgery not compatible with a visualization of the pleural slip in echography: surgery of pneumothorax or liquid effusion
* History likely to disturb the detection of pleural slip on ultrasound: pneumothorax surgery
* Predictable intubation difficulties and the need for selective bronchial blocker intubation
* Pregnant or lactating women
Trospium Chloride vs Tamsulosin in Treatment of Ureteral Stent Related Symptoms:

This study will be conducted to compare the efficacy and safety of Trospium chloride versus Tamsulosin for treatment of ureteral stent related symptoms.

Eligible patients will be randomized to one of the two treatment groups. Group 1 patients will receive 30 mg of Trospium chloride tablet twice daily, while group 2 patients will receive 0.4 mg of Tamsulosin tablet once daily, until the stent is removed. Ureteral Stent Symptoms Questionnaire (USSQ) will be used to evaluate the symptoms of the patients with DJ stent after 2 weeks of inserting the stent.

Eligibility Criteria:
Inclusion Criteria:

* Patients with double "J" (DJ) stent after ureteroscopy or for drainage of obstructed kidney

Exclusion Criteria:

1. Patients with hypersensitivity to either Trospium chloride or Tamsulosin
2. Patients with complications after DJ insertion (such as fever, hematuria, perforation, stent migration).
3. Patients receiving alpha blockers or anticholinergic medications for any other reason.
4. Patients with history of orthostatic hypotension.
5. Pregnant or breastfeeding females.
6. Patients with hepatic impairment (Child-Pugh score \>9).
7. Patients with severe renal impairment with creatinine clearance of less than 15 mL/min.
8. Patients with narrow-angle glaucoma.
9. Patients with history of urinary retention or gastric retention.