cyrilzakka/clinical-trials huggingface dataset:
Coadministration of Measles-rubella and Rotavirus Vaccines

The investigators aim to establish the non-inferiority of concomitant administration of measles-rubella and rotavirus vaccines to measles-rubella vaccine given alone in terms of measles seroconversion rates. The primary study hypothesis is the measles seroconversion rate as defined by the percentage of children seroconverting to measles with a measles serum antibody concentration of \>=1:120 at 8 weeks post vaccination after the concomitant administration of measles-rubella and rotavirus vaccines is non-inferior to that obtained when measles-rubella vaccine is given alone in children 9 months of age who have received a primary rotavirus vaccine series with the first dose between 6 and 10 weeks and the second at least 4 weeks later and are seronegative for measles antibody in the pre-vaccination sample.


Eligibility Criteria:
Inclusion Criteria:

* Child 9 months of age eligible for measles-rubella vaccination
* documented evidence of a primary rotavirus vaccine series with first dose between 6 and 10 weeks of age and second dose at least 4 weeks after first dose
* healthy infants free of chronic or serious medical condition as determined by history and physical examination at time of study enrollment
* parents/guardians of each participant are able to understand and follow study procedures and agree to participate in study by providing signed informed consent

Exclusion Criteria:

* hypersensitivity to any component of measles-rubella or Rotarix vaccine which would preclude administration of the vaccine
* history of intussusception, intestinal malformations, or abdominal surgery
* known history of measles and/or rubella disease
* history of previous receipt of measles and/or rubella vaccine
* use of any immunosuppressive drugs or immunoglobulin and/or blood products since birth or anticipated during study period
* current enrolment in any other intervention trial or use of any investigational drug or vaccine throughout the study period
* any participant who reports planning to leave the study area before the completion of the study
* acute diarrhea (defined as ≥3 loose stools within a 24-hour period) or vomiting (defined as projectile vomiting or any vomiting at the discretion of the clinician) at the time of enrollment or within the last 24 hours
* acute febrile illness (defined as a temperature of ≥38°C) at the time of enrollment.
Annular Array Ultrasound in Ophthalmology

The objective of this research is to improve the care of ocular disease and disorders, in particular the changes in the eye associated with diabetes, by providing clinicians with dramatically improved ultrasonic images of the entire eye. The research combines advanced high-frequency, high-resolution ultrasonic annular arrays transducers with new processing techniques designed to overcome several limits that have been reached with conventional high frequency ultrasound systems. The investigators propose that diagnosis of eye diseases using annular arrays can be more effective than the conventional ultrasound images by at least 50%; i.e., that for every 2 posterior vitreous detachments detected conventionally, 3 will be detected with the annular arrays.

The goal of this study is to develop and evaluate advanced annular-array transducer technology for rapid, high-definition imaging. The study will assess high frequency ultrasound (HFU, 40 \& 20 MegaHertz) annular arrays in imaging posterior vitreous detachments (PVDs) associated with diabetic retinopathy, the leading cause of blindness in the US working-age population according to Prevent Blindness America. Current HFU instruments do not use linear arrays for such applications because of a variety of technical and cost reasons. Instead, current HFU instruments use mechanically scanned, single-element transducers, which provide fine-resolution images over a very limited depth of field (DOF). For ophthalmic applications, a shallow DOF causes most ocular anatomy to be imaged with poor definition compared to the in-focus region; therefore, because only a small portion of the eye is in focus at a given time, detection and assessment of ocular conditions such as PVD are prone to inaccuracies and false-negative determinations. Annular-array transducers offer a promising approach to significantly extend DOF and to increase the depth range over which fine-lateral resolution is provided. The investigators will validate system performance using animal experiments and human-subject examinations. First, in vivo animal experiments will be conducted to evaluate a 40-MegaHertz (MHz) annular array for anterior-segment imaging and a 20-MHz annular array for posterior segment and full-globe imaging. The investigators will test the hypothesis that 20-MHz annular arrays improve detection of PVD. Validation of this hypothesis will significantly improve our ability to assess disease status in diabetic retinopathy.

Eligibility Criteria:
Inclusion Criteria:

* over age 60
* people with diabetic retinopathy or posterior vitreous detachments

Exclusion Criteria:

* under age 60
A First-in-human Study of HCR-188 in Overweight or Obese Otherwise Healthy Volunteers Without Type 2 Diabetes

This is a first-in-human study evaluating the safety, tolerability, pharmacokinetics, immunogenicity and pharmacodynamics of single and multiple doses of HCR-188 administered as subcutaneous injection(s).

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study in overweight or obese volunteers without type 2 diabetes mellitus. Up to 5 SAD cohorts and up to 5 MAD cohorts may be enrolled.

Multiple dosing regimens are planned to be evaluated in the MAD portion of the study.

The duration of the study will be approximately 20 weeks per each participant completing the entire study.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) of 27 to 40 kg/m2, inclusive
* Except for overweight or obese, otherwise healthy as determined by the Investigator
* Stable body weight, defined as a \< 5 kg change during the 8 weeks prior to screening
* Females of childbearing potential must agree to use highly effective methods of contraception during the participation in the study
* Males must be surgically sterile, abstinent, or must agree to use highly effective methods of contraception during participation in the study

Exclusion Criteria:

* History of or active cardiovascular (CV) disease
* History of active pulmonary diseases
* History of immunosuppressive, chemotherapeutic, or radiation treatment within the last 12 months prior to Screening
* History of malignancy in the past 12 months or active malignancy
* History of bariatric surgery or use of gastric balloons
* History of diabetes mellitus Type 1 or 2
* History of chronic liver disease
* Pregnant or breastfeeding, or a positive pregnancy test at Screening
* Treatment with medications that may cause significant weight gain or weight loss
The Benefits of Deep Neuromuscular Block and Sugammadex in Laparoscopic Colorectal Surgery

Pneumoperitoneum, the use of carbon dioxide, presents some disadvantages, including a risk of hypercarbia and respiratory acidosis during surgery in the respiratory system, and of an increased mean arterial pressure and systemic vascular resistance due to sympathetic excitation in the cardiovascular system. 10\~15 mmHg intra-abdominal pressure is required in order to achieve a pneumoperitoneum, and increased abdominal pressure following a pneumoperitoneum causes hemodynamic changes leading to a reduced cardiac function by increasing the left ventricular end systolic wall stress and the right and left ventricular filling pressure, while decreasing the stroke volume and cardiac index. The author compared the intra-abdominal pressure necessary to achieve a pneumoperitoneum under deep muscle relaxation and medium muscle relaxation in ten patients undergoing laparoscopic surgery for colorectal cancer as part of preliminary research. The results showed that deep muscle relaxation, compared to medium muscle relaxation, was able to lower the intra-abdominal pressure by an average of 5.6 mmHg (13.2 ± 0.8 vs 7.6 ± 1.1) and the inspiratory pressure by an average of 8. Above all, even after lowering the intra-abdominal pressure with deep muscle relaxation, the surgeon was able to maintain a view almost identical to the one afforded by medium muscle relaxation. However, up until now, no reports have clearly indicated the change in pneumoperitoneum pressure, the patient's hemodynamic change, post-operative recovery, and surgical prognosis depending on the depth of muscle relaxation.Against this background, this study aims to identify the degree to which intra-abdominal pressure in laparoscopic colorectal surgery can be reduced by deep muscle relaxation, and the corresponding advantages this method presents in terms of physiological changes such as hemodynamic and respiratory system changes. In addition, the study intends to examine the difference between deep muscle relaxation and medium muscle relaxation in terms of surgical prognosis, including their effects on post-operative pain and on the patient's recovery of intestinal mobility.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 19 to 80 scheduled to undergo laparoscopic colorectal or rectal surgery below the ASA class 3

Exclusion Criteria:

* Patients with neuromuscular disease/patients with a personal history or family history of malignant hyperthermia/patients with a serious heart, kidney (GFR \< 60) or liver condition (ALT/AST \> 100)/ patients who have had colorectal or rectal surgery/obese patients (BMI ≥35)
ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)

This study will compare Measles, Mumps, Rubella, and Varicella Vaccine (V221) and concomitant administration of Varivax and M-M-R II vaccines in healthy children.


Eligibility Criteria:
Inclusion Criteria:

* In good health
* Negative clinical history of varicella, shingles, measles, mumps, and rubella

Exclusion Criteria:

* Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination
* Any immune impairment or deficiency
* Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination
* Vaccination with an inactive vaccine with in the past 14 days
* Vaccination with a live vaccine within the past 30 days
* Immune globulin or any blood product administered in the past 3 months
A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma

The study is being conducted to evaluate the effect of 3 dosing regimens of povorcitinib on pulmonary function


Eligibility Criteria:
Inclusion Criteria:

* Physician-diagnosed asthma requiring treatment with medium- to high-dose ICS-LABA for at least 12 months prior to screening.
* Pre-BD FEV1 \< 80% predicted according to central over read value at Visit 2.
* Documented historical post-BD reversibility of FEV1 ≥ 12% and ≥ 200 mL in FEV1.
* At least 2 documented asthma exacerbations (requiring treatment with systemic CS, hospitalization, or emergency department visit) within 12 months prior to screening but not within the past 4 weeks prior to screening
* ACQ-6 ≥ 1.5 at screening.

Exclusion Criteria:

* Maintenance use of asthma controllers other than ICS-LABA.
* Have undergone bronchial thermoplasty.
* Current smokers or participants with a smoking history of ≥ 10 pack-years and participants using vaping products, including electronic cigarettes.
* Women who are pregnant (or who are considering pregnancy) or breastfeeding.
* Current conditions or history of other diseases, as follows:
* Clinically important pulmonary disease other than asthma ,Thrombocytopenia, coagulopathy, or platelet dysfunction.
* Venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, moderate to severe heart failure (NYHA Class III or IV), cerebrovascular accident, myocardial infarction, coronary stenting, or CABG surgery.
* Diagnosis of other significant cardiovascular diseases, including but not limited to angina, peripheral arterial disease, or uncontrolled arrhythmias such as atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, and forms of carditis.
* Recipient of an organ transplant that requires continued immunosuppression.
* Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome).
* Any malignancies or history of malignancies.
* Chronic or recurrent infectious disease.
* Receipt of any biologic drugs used for asthma \< 12 weeks or 5 half-lives (if known), whichever is longer, prior to screening
Testing the Effectiveness of an Online Behavioral Intervention in Reducing Loneliness

This study will use a longitudinal randomized experimental design. Participants will be randomly assigned to either a positive affect skills intervention or a psychoeducation control group and assessed with questionnaires at baseline and immediately post 8-week intervention.

Participants will be randomly assigned to either a positive affect skills intervention or a psychoeducation control group, with each intervention lasting 8-weeks. Participants in the positive affect skills intervention will have full access to the unchanged Happify platform.

The psychoeducation control group participants will use a version of the Happify platform that encourages thinking about well-being through quizzes and polls without providing any instructions for promotion (i.e., Wait-list Control). Participants will be asked to complete questionnaires before and after the 8-week program, at which point study participation will end.

Eligibility Criteria:
Inclusion Criteria:

* No prior experience on the Happify platform (new user registration)
* Located in the United States
* Self reported loneliness/desire to be more connected to others

Exclusion Criteria:

* Participants who are under the age of 18, reside outside of the United States, have previously registered for Happify, or did not self report loneliness/desire to be more connected with others
Medication Reconciliation in Oncologic Patients

To improve medication reconciliation in oncologic patients in healthcare transitions through an alliance between a Cancer Institute and the community pharmacies and a new integrated IT platform.

This trial will explore the alliance between a Cancer Institute and the community pharmacies to improve medication reconciliation in healthcare transitions, and will validate a new integrated IT platform.

Cancer patients receiving an oncologic treatment will be asked to choose a pharmacy participating to the trial, and to perform the pharmacological survey before every cycle of chemotherapy.

This will be sent through the new IT platform to the electronic medical record of IRST, and the Oncologist will perform the reconciliation.

Data about concomitant medications and possible interactions will be exensively analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Adult ≥18 years old
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1
* Patients receiving an anticancer treatment
* Clear understanding of the Italian language; written informed consent.

Exclusion Criteria:

- None
FOLFOXIRI Compared With FOLFIRI for Metastatic Colorectal Cancer

The purpose of the study is to evaluate if the exposure to all the three active cytotoxic agents (FOLFOXIRI regimen) is superior in terms of response rate to conventional chemotherapy with the FOLFIRI regimen as first-line treatment of metastatic colorectal cancer patients.

Survival of patients with metastatic colorectal cancer is correlated with the proportion of patients who receive all the three active drugs in the course of the disease, but not with the proportion of patients who receive any second-line therapy. In a sequential strategy, not all patients who progress after first-line chemotherapy are able to receive second-line treatment. Moreover, there is a correlation between the response rate to chemotherapy and the postchemotherapy radical resection rate of metastases.

Therefore, a way to improve the outcome of metastatic colorectal cancer patients could be to administer a first-line regimen containing the three active agents.

Eligibility Criteria:
Inclusion Criteria:

* adenocarcinoma of the colon or rectum
* unresectable metastatic disease
* age 18 to 75 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower if age 70 years or younger or ECOG performance status of 0 if age 71 to 75 years measurable disease according to WHOcriteria
* leukocyte count of at least 3,500/mm3, neutrophils count of at least 1,500/mm3, platelet count of at least 100,000/mm3
* serum creatinine of 1.3 mg/dL or less
* serum bilirubin less than 1.5 mg/dL and AST, ALT, and alkaline phosphatase 2.5 x normal values or less (\</= 5 if liver metastases)
* previous fluoropyrimidine-based adjuvant chemotherapy was allowed if ended more than 6 months before random assignment

Exclusion Criteria:

* previous palliative chemotherapy for metastatic disease
* previous chemotherapy including irinotecan or oxaliplatin
* symptomatic cardiac disease, myocardial infarction in the last 24 months or uncontrolled arrhythmia
* active infections
* inflammatory bowel disease
* total colectomy
Tooth Extraction With Deep Sedation in Children: A Retrospective Study

In this study it's aimed to evaluated the patients in whom dental local anesthetic attempts were failed due to anxiety or fear and referred to our clinic for tooth extraction with deep sedation. All patients dates will evaluate from their patient file retrospectively from 2011 to 2014.

Majority of dental treatments can be performed under local anesthesia. However, this is not always possible for pediatric non-cooperated patients with severe anxiety. In these patients, unpleasant dental experiences may lead to development of dental phobia when they become adults . Therefore, it is important to eradicate anxiety, and to prevent a possible psychological trauma in pediatric patients. For this purpose, psychological and medical methods have been applied to increase patient compliance. It has been proven that general anesthesia especially prevents dental phobia in elderly, and increases the quality of life related to oral health. In this study we aimed to evaluated the patients in whom dental local anesthetic attempts were failed due to anxiety or fear and referred to our clinic for tooth extraction with deep sedation. All patients dates will evaluate from their patient file retrospectively from 2011 to 2014.

Eligibility Criteria:
Inclusion Criteria:

* the patients who dental treatment was performed with deep sedation

Exclusion Criteria:

* the patients who dental treatment was performed local anesthesia or general anesthesia
Proprioception and Meditation

In past work is has been shown that yoga can be as effective as a standard balance or Tai Chi protocol; however, there is an inability to distinguish between the mind and body contributions of yoga training. This study will compare an accepted proprioceptive training program to a meditation program which concentrates on body awareness in individuals with Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* An individual must be between 40 and 90 years of age with mild to moderate Parkinson's Disease (Hoehn \& Yahr stages I-III).

Exclusion Criteria:

* Participants that have been part of a formal training program that targeted lower body strength, balance or proprioception within the past six months
* Participants that have any uncontrolled nerve (except Parkinson's patients taking appropriate medication), bone or joint, or heart disease;
* Participants that have been advised by a doctor to not exercise;
* Participants that have regularly practiced yoga at least twice per week within the past six months;
* Participants that is unable to consent;
* Participants that is a prisoner;
* Participants that are pregnant.
Survival Study of Docetaxel and Carboplatin as Neo-Adjuvant Vs Adjuvant Chemotherapy in Early Stage NSLC

The objective of the trial is to determine whether 3 cycles of TP (docetaxel plus cisplatin) after complete operation will improve survival when compared with 3 cycles of TP prior to complete resection for NSCLC.

Non-small-cell lung cancer (NSCLC) accounts for approximately 80% of lung cancers diagnosed worldwide. Surgical resection offers the best chance for cure for those patients diagnosed with early-stage disease, however, the vast majority of patients experience eventually relapse or metastasis. The rationale of neoadjuvant or adjuvant chemotherapy for early stage NSCLC lies in the possibility of eradicating micro-metastasis disease, so it appears to improve survival by reducing the occurrence of distant metastases. Meta analysis, CALGB 9633, JBR 10 and ANITA trials have shown postoperative (adjuvant) CT after complete resection will prolong survival. On the other hand, Depierre et al had conducted a trial to demonstrate preoperative (neoadjuvant ) chemotherapy in early stage NSCLC appears to improve survival. We need a head to head trial to comparing neoadjuvant with adjuvant chemotherapy to answer which treatment model is better to early stager NSCLC. Based on proven activity and survival benefit in advance NSCLC, docetaxel has been introduced into neoadjuvant therapy, even as a potential option in adjuvant setting.

Comparison: 3 cycles of TP after complete operation compared to 3 cycles of TP prior to complete resection for NSCLC.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed stage IB-IIIA non-small cell lung cancer patients,without previous chemotherapy, radiotherapy or target-therapy;
* age from 18 to 75;
* PS with ECOC 0-1;
* Adequate haematological and Hepatic- renal function;
* Expected to live longer than 12 months;
* The informed consent should be signed.

Exclusion Criteria:

* Patients with Small Cell Lung Cancer;
* Already receiving any prior anti-cancer treatment;
* Pregnant women;
* Uncontrolled diabetes, mental disease;
* Hepatic and renal function failure;
* The investigators believe the patient is not suitable to be enrolled in the study
Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures

This study is a case-control prospective, clinal trial to assess the safety and efficacy of the allogeneic adipose derived mesenchymal stem cell transplantation on the healing of recent tibial fracture in 40 patients.

In this study all eligible patients divided in 2 group.20 patients received allogeneic adipose derived mesenchymal stem cell in the fractured site (case group) and other patients received the placebo in the fractured site (control group) .

To assess the outcomes, we will evaluate the patients at 2, 6 weeks and 3, 6 months after transplantation by: X-ray, BMD , VAS and biochemical analysis with laboratory tests.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years
* The presence of tibial fracture based on X ray
* tibial fracture is limited to diaphysial

Exclusion Criteria:

* Addiction
* Pregnancy
* liver or kidney disease or uncontrolled diabetes or heart and lung disease
* immune deficiency