cyrilzakka/clinical-trials huggingface dataset:
Treatment of Human Gingivitis With Amnion-derived Cellular Cytokine Solution (ACCS)

The purpose of this study is to evaluate the safety of oral topical application of Amnion-derived Cellular Cytokine Solution (ACCS) in subjects with gingivitis

This randomized blinded study will evaluate the use of ACCS in subjects with gingivitis. Two doses of ACCS will be used. It will be given topically intra-orally daily Monday through Friday for 2 weeks. In the first cohort, a low dose of ACCS or saline will be given by random chance. If there are no safety issues, cohort two will include a higher dose of ACCS randomized with saline. Pocket depth, plaque index, gingival index, and bleeding on probing will be assessed. To assess shifts in supragingival flora, a qualitative and quantitative microbial analysis will be performed for common oral bacteria. There will also be an analysis of inflammatory cytokines in crevicular fluid at the beginning and end of the study. Comparisons of adverse events and outcomes will be made between the subjects receiving low dose ACCS, high dose ACCS, and saline.

Eligibility Criteria:
Inclusion Criteria:

* good general health
* ages 18-70 years
* minimum of 20 natural teeth
* modified gingival index score of 2.0 or greater and \>40 percent bleeding sites at initial presentation.

Exclusion Criteria:

* presence of orthodontic appliance
* soft or hard tissue tumor of the oral cavity
* carious lesion requiring immediate treatment
* participation in another clinical trial within 30 days
* pregnant or breast-feeding women
* women of child-bearing potential refusing to use an acceptable method of birth control
* antibiotic therapy within the last 30 days
* chronic use (\> 3 times/week) of non-steroidal anti-inflammatory medications (NSAID). Any use of steroids. Low dose (\<325 mg) aspirin is allowed.
* immune-compromised subjects
* subjects with liver or kidney dysfunction on blood tests as evidenced by a value equal to or greater than 2X the upper limit of normal.
* any medical history or any concomitant medication that might affect the assessment of the study treatment or periodontal tissues such as diabetes rheumatoid arthritis, Crohn's disease, use of nifedipine, phenytoin (Dilantin), anticoagulant medications (e.g. warfarin), ongoing cancer treatment either with radiation of chemotherapy.
Peritoneal Ropivacaine Infiltration on Postoperative Pain in Children Affected

The aim of this study was to evaluate the analgesic effect of intraperitoneal infiltration of ropivacaine in children undergoing laparoscopic surgery.

1. Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.
2. Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
3. Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources .
4. Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information .
5. Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.
6. Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect.
7. Plan for missing data to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results
8. Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan

Eligibility Criteria:
Inclusion Criteria:

1. Between 6 months and 5years.
2. Laparoscopic inguinal hernia repair
3. Laparoscopic testicular descent fixation

Exclusion Criteria:

1. Patient who are suffering from mental disease
2. Patient who suffering from neuromuscular disease
3. Local anesthetic allergy
4. Patient who needs directly into ICU after the operation.
Retreatment of Recurrent Dupuytren's Contractures

The objectives of this study are to assess the safety and efficacy of AA4500 in the retreatment of recurrent contractures in joints that were effectively treated with AA4500 in a previous Auxilium-sponsored Phase 3 study.

Open-label, Phase 4 study in subjects who are currently participating in the long-term follow-up study (ie, AUX-CC-860) in the United States, Australia, or Europe and who have recurrence of contracture (ie, joint contracture increases by at least 20 degrees compared with the Day 30 value after the last injection in a Phase 3 Auxilium-sponsored study and a palpable cord present) in a joint that was effectively treated (ie, reduction in contracture to 5 degrees or less 30 days after the last injection) with AA4500 in a Phase 3 Auxilium-sponsored study.

Subjects who experience recurrence of contracture in one or more effectively treated joints may be enrolled in this retreatment study after the investigator determines subject eligibility and after informed consent has been obtained. The investigator will treat the cord affecting the recurrent joint with up to three injections. Only one recurrent joint will be treated in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Provide written informed consent
2. Be currently participating in the AUX-CC-860 follow-up study
3. Have at least one joint with all of the following:

   * The joint was effectively treated (had a correction to 5 degrees or less at the Day 30 evaluation after the last injection of AA4500) in a previous Auxilium Phase 3 study
   * The effectively treated joint has an increase in contracture of at least 20 degrees compared with the Day 30 value after the last injection of AA4500 in a previous Auxilium Phase 3 study
   * A palpable cord is present in the joint to be treated
4. Be able to comply with the study visit schedule as specified in the protocol

Exclusion Criteria:

1. Is a pregnant or lactating female or female intending to become pregnant during the study
2. Has hypersensitivity to AA4500 or any of the AA4500 excipients
3. Is currently receiving or plans to receive anticoagulant medication or has received anticoagulant medication (except for equal to or less than 150 mg aspirin daily and over-the-counter nonsteroidal antiinflammatory drugs \[NSAIDs\]) within 7 days before injection of AA4500
Comparison of Hyaluronidase and Dexametasone in Reduction of Postoperative Edema

The present study is designed to reveal effectiveness of hyaluronidase and dexamethasone on reduction of postoperative edema, pain, trismus, and infection. For this purpose, 60 participants with symmetrical mandibular wisdom teeth enrolled the present study. All measurements and evaluations were performed before and 1, 2, 3, and 7 days later the operation.


Eligibility Criteria:
Inclusion Criteria:

* symmetrical mandibular wisdom teeth with bone retention
* patients who are signed informed consent and acceptance of study involvement forms

Exclusion Criteria:

* existence of any systemic disease
* existence of any periodical drug intake
* existence of difference in operation times of right and left impacted wisdom teeth extractions more than 5 minutes
* existence of pregnancy
* existence of breastfeeding
Optimizing Treatment for Patients with Juvenile Idiopathic Arthritis in Sustained Remission: the MOVE-JIA Trial

The goal of this clinical trial is to compare three different maintenance and step-down treatment strategies in children and adolescents with juvenile idiopathic arthritis in sustained remission. The main questions it aims to answer are:

* Is the proportion of study participants with a disease flare different between each of the two drug withdrawal arms and the stable treatment arm during 12 months?
* Does the proportion of study participants with a disease flare differ between the two drug withdrawal arms during 12 months?
* How long time does it take before a disease flare occurs, and how long does it take before disease remission is reestablished for participants in the different treatment arms?

Participants will be randomized to either A) continued stable treatment with methotrexate and tumor-necrosis alpha inhibitor (TNFi); B) gradual withdrawal of methotrexate while continued stable dose TNFi; or C) gradual withdrawal of TNFi.

Participants will be examined every 4 month, and with extra visits if they experience increased symptoms or suspect a disease flare. If a flare occurs, the medications received at study inclusion will be restarted.


Eligibility Criteria:
Inclusion Criteria:

1. Participant must be 2-\<18 years of age at the time of signing the informed consent.
2. Fulfilment of the International League of Associations for Rheumatology (ILAR) classification criteria for non-systemic Juvenile Idiopathic Arthritis (JIA).
3. Inactive disease for ≥12 months documented at a minimum of 2 consecutive visits and documented inactive disease according to Wallace criteria at inclusion, and no active uveitis for ≥24 months.
4. Stable treatment with methotrexate and Tumor Necrosis Factor inhibitor (TNFi) for ≥6 months. Weight adjustments permitted.
5. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
6. Male participants: No contraceptive measures necessary.
7. Female participants: contraception guidance for women of childbearing potential (WOCP).

Exclusion Criteria:

1. Chronic widespread pain syndrome
2. Major comorbidity including uncontrolled infectious, neurological or mental disease, malignant disease, severe heart failure, severe renal failure, active ulcus ventriculi, and uncontrolled diabetes mellitus.
3. Use of oral, intra-articular, intramuscular or intravenous corticosteroids due to JIA less than 12 months prior to randomization.
4. Participating in an ongoing clinical randomized study..
5. Drug/alcohol abuse which hampers adherence to the study protocol as based on the investigators judgement.
6. Language barriers that hamper adherence to the study protocol.
7. Pregnancy or breastfeeding.
8. Any condition that in the view of the investigator would suggest that the patient is unable to comply with the study protocol and procedures.
9. Unwillingness to use safe contraception for sexually active WOCP.
Comparative Effects of Mulligan Straight Leg Raise Technique Versus Slump Stretching on Pain, Disability and Hip Range of Motion in Patients With Chronic Low Back Pain.

The goal of this clinical trial is to examine the effect of mulligan straight leg raise versus slump stretching on pain, disability and hip range of motion in patient with low back pain. . Convenient sampling technique will be used to enroll the patients. Patients will be inquire into basis of pre formulated eligibility criteria. Written Consent will be taken from each patient before starting interventional sessions. Sample size of this study will consist on the participants who will qualify for both inclusion an exclusion criteria. Both groups will receive ultrasonic therapy and hot pack therapy as baseline treatment. Group A will receive mulligan straight leg raise and group B will receive slump stretching. The assessment of patients will be done at baseline, 4th and 8th week. The outcomes from patients will be calculated by using Visual Analogue Scale (VAS), Goniometer and ODI. The comparison between pre-treatment and post-treatment data will be done after 8th week. Data will be analyzed through SPSS 25.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have active positive knee extension test(APKET).
* Patient having low back pain for more than 3 months.
* Patients who have been sitting for three hours.

Exclusion Criteria:

* Any active infection, tumor, tuberculosis.
* History of trauma.
* Subject with intervertebral disc prolapse.
Systems Addressing Frail Elders (SAFE) Care Implementation

Systems Addressing Frail Elders (SAFE) Care is a nurse-led interprofessional team model to rapidly identify and provide safe and effective inpatient care to high risk older adults and help support their successful transition back to the community. Developed and demonstrated to be effective in one hospital - the model is now being disseminated and studied in three additional hospitals (multiple organizational case study).

Three Magnet hospitals in Los Angeles County (Huntington Hospital, Torrance Memorial Medical Center and Ronald Reagan UCLA Health System) are collaborating on this demonstration and evaluation project (Multiple Case-Study Design). The project will engage interprofessional hospital leadership; provide training and coaching in implementation processes of the SAFE Care model; and track outcome of the SAFE Care model as implemented in the three collaborating site hospitals (three case studies). The investigators hope to contribute to the existing state of the science in dissemination and implementation of evidenced-based innovations. The collective data from the three sites (collected through interviews with hospital leadership and staff and with de-identified patient data on program implementation outcomes) will provide information about the effectiveness of the implementation process and support further dissemination.

Eligibility Criteria:
Inclusion criteria:

Organizational Leadership Nursing Unit Leadership/staff Adults aged 65 years

Exclusion criteria:

65 years and older that are on hospice protocols or dying/comfort care protocols.
Study Comparing the Efficacy of Venlafaxine XR Vs. SSRIs and Conventional Antidepressants in Depressed Patients

This study is an open-label, randomized, multi-center study conducted in a typical psychiatric outpatient practice in China. This study is intended to collect data on the efficacy and safety of venlafaxine XR (Efexor XR®) versus SSRIs and conventional antidepressants in depressed patients that previously failed antidepressant treatment. This data will be used to guide psychiatrists on recommendations for clinic use.


Eligibility Criteria:
Main Inclusion Criteria:

* Males or females, 18 -65 years of age
* Outpatients
* Major depressive disorder based on DSM-IV criteria
* The baseline score of 17-item HAM-D³17
* Switchers from prior antidepressants, who have had no satisfactory improvement (normally after a minimum of 8weeks of treatment), with an approved antidepressant medication or have experienced intolerance due to side effects to their antidepressant medication based on clinical discretion
* Provide written informed consent
* If female is of childbearing potential, must be confirmed no pregnancy at baseline, and use a medically acceptable method of contraception throughout the study.

Main Exclusion Criteria:

* Hypersensitivity to venlafaxine;
* Clinically significant renal or hepatic disease or any other medical disease that, in the opinion of the investigator, might compromise the study, including seizure
* Alcohol or drug abuse within the last year
* A recent history of myocardial infarction or unstable heart disease (within 6 months of baseline)
* Bipolar disorder
* For female, known or suspected pregnancy or breast feeding
* Use of a monoamine oxidase inhibitor (MAOI) within 14 days of baseline; use of any investigational drug within 30 days of baseline.
* Patients have prior use of venlafaxine or use of venlafaxine for the current episode.
Laparoscopic Vs. Open Prostatectomy Outcomes

This study is aimed at discovering the differences in outcomes, regarding quality of life issues(continence, impotence) of patients who have had either laparoscopic or open surgical technique for prostate cancer.

This study is a post surgical, data collection effort in order to gather definitive, Quality of Life(continence, impotence) information regarding the outcomes of patients who have undergone either Laparoscopic vs. Prostatectomy surgeries for Prostate Cancer. As part of the study, 200 subject's medical records will be retrospectively reviewed and 100 current subjects will be prospectively contacted. The information collected may benefit patients who undergo a prostatectomy

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have undergone a prostatectomy

Exclusion Criteria:

* none
Pharyngeal Sensitivity in Diagnosis Algorithm for Sleep Apnea Syndrome

Pharyngeal sensitivity is a determinant parameter of pharyngeal functioning, particularly regarding protective dilator reflexes of upper airway. Preliminary results have suggested that the use of this parameter in diagnosis algorithm such as linear discriminant analysis and random forest could predict the presence of sleep apnea syndrome in almost 98% of patients. Our study aims at validating a new diagnosis method of sleep disordered breathing which will be compared with nocturnal polysomnography, the reference method to diagnose sleep disordered breathing. Pharyngeal sensitivity will be measured using the SENSITEST device which allows an automatic measurement of the pharyngeal sensation. The use of this parameter in diagnosis algorithm will be compared with polysomnographic results.


Eligibility Criteria:
Inclusion Criteria:

* consecutively included patients with suspicion of sleep apnea syndrome
* patients who have signed the informed consent form
* patients with body mass index less than or equal 30 kg/m2

Exclusion Criteria:

* body mass index more than 30 kg/m2
* pharyngeal infection or allergic rhinitis less than 2 weeks before recordings
* craniofacial anomalies and/or limited mouth opening and/or teeth position compromising mouthpiece installation and stability during measurement
* instable dentures
* exaggerated gag reflex preventing pharynx examination
* no visibility of the soft palate
* systemic or topical anti-inflammatory treatments
* treatments that may increase the occurence of nocturnal respiratory events and/or leading to daytime sleepiness and cognitive impairment
* cardiac failure, or symptoms suggesting cardiac failure
* history of stroke
* contraindication for using xylocaine spray
* no affiliation to national insurance
* patient participating in another research study involving drugs that may interfere with sleep recordings and/or measurement of pharyngeal sensation
* patient subjected to exclusion period following participation in another research study
A Drug Interaction Study of Montelukast and Levocetirizine

The purpose of this study is to evaluate the drug-drug interaction between montelukast sodium and levocetirizine dihydrochloride in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male
* Age between 20 and 55
* Signed informed consent

Exclusion Criteria:

* Has a history of hypersensitivity to IP ingredients
* Hypotension or hypertension
* Has a history of acute infection within 14days of screening
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Tocilizumab vs Abatacept

This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.

This is a non-randomized, non-interventional study that is part of the DREAM Study of Brigham and Women's Hospital. DREAM is led by Dr. Madhav Thambisetty, MD, PhD, Chief of the Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging (NIA) intramural research program. This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.

Eligibility Criteria:
Please see https://docs.google.com/spreadsheets/d/1paz3s8atiPsH8kyaCgxB8gcqQYNnK1Cv_om79IfIAsI/edit?usp=sharing or Appendix A for full code and algorithm definitions.

Medicare timeframe: 2007 to 2017 (end of data availability).

Inclusion Criteria:

* 1. No prior use of tocilizumab or abatacept anytime prior to cohort entry date
* 2. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date

Exclusion Criteria:

* 1. Prior history of dementia measured anytime prior to cohort entry date
* 2. No prior history of rheumatoid arthritis recorded in the 365 days prior to cohort entry date
* 3. Prior history of nursing home admission in the 365 days prior to the cohort entry date
Evaluation of ETC-1002 vs Placebo in Patients Receiving Ongoing Statin Therapy

The purpose of this research study is to see how ETC-1002 is tolerated in the body and how ETC-1002 affects the levels of LDL-C (bad cholesterol) in patients receiving ongoing statin therapy.

Approximately 132 hypercholesterolemic patients already taking statin therapy to treat elevated LDL-C will be randomized in a ratio of 1:1:1 to receive either ETC-1002 (120 mg or 180 mg dose), or placebo for 12 weeks in addition to ongoing statin therapy. This study will explore the safety and efficacy of ETC-1002 when given to patients receiving statin therapy.

Eligibility Criteria:
Inclusion Criteria:

* Fasting, calculated mean LDL-C ≥130 mg/dL and ≤220 mg/dL
* Fasting mean TG level ≤400 mg/dL
* Stable statin therapy for at least 3 months prior to screening: atorvastatin (10 or 20 mg daily), simvastatin (5, 10 or 20 mg daily), rosuvastatin (5 or 10 mg daily), or pravastatin (10, 20 or 40 mg daily)

Exclusion Criteria:

* Clinically significant cardiovascular disease within 12 months of screening
* Current muscle-related symptoms that may be due to ongoing statin therapy or a history of certain lab abnormalities that occurred during statin therapy and resolved when statin therapy was discontinued
* Type 1 diabetes or uncontrolled type 2 diabetes
* Use of metformin or thiazolidinediones (TZD) within 4 weeks of screening
* History of chronic musculoskeletal symptoms such as fibromyalgia
* Uncontrolled hypothyroidism
* Liver disease or dysfunction
* Renal dysfunction or nephritic syndrome
* Gastrointestinal conditions or procedures or surgeries
* Hematologic or coagulation disorders or low hemoglobin levels
* HIV or AIDS
* History of malignancy
* History of drug or alcohol abuse within 2 years
* Use of experimental or investigational drugs within 30 days of screening
* Use of ETC-1002 in a previous clinical study