cyrilzakka/clinical-trials huggingface dataset:
Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis

This study aims to compare antibiotic treatment versus surgery for patients with uncomplicated appendicitis.

The study will include patients aged 16 and over, with a first admission with right iliac fossa pain and a raised white cell count or C-reactive protein. Patients will be randomised electronically in a 1:1 ratio either to undergo emergency appendectomy or to receive intravenous antibiotics as an inpatient, until clinical and biochemical improvement is observed, followed by outpatient oral antibiotics. Those who have surgery will have 3 post-operative doses of intravenous antibiotics, unless perforation was identified at the time of surgery, in which case, microbiology will be contacted to advise regarding antibiotic choice and duration. Follow-up by telephone interview will be at 1 week, 1, 3 and 12-month intervals.

Eligibility Criteria:
Inclusion Criteria:

* Right iliac fossa pain
* 1st episode in the past 1 year
* Raised WCC or CRP
* Fluent in English

Exclusion Criteria:

* History of inflammatory bowel disease or appendectomy
* B-HCG positive
* Significant co-morbidities
* Complicated appendicitis as proven by ultrasound, CT or MRI
* Anaphylaxis to penicillin
Cardiogenomics Registry

This is a continuous blood banking study that will archive plasma and blood permitting DNA and plasma analysis at a future date. Subjects are recruited at the time of a clinically required procedure and blood samples are collected and banked and used for future research. The main purpose of this study is to investigate the interaction of multiple phenotypes and genotypes and their impact on cardiovascular disease events and measures of atherosclerosis progression.


Eligibility Criteria:
Inclusion Criteria:

* \> 17 years of age
* Undergoing a clinical required cardiovascular procedure
* Agree to donation of blood sample
* Provide written informed consent and Authorization for Use/Disclosure of PHI

Exclusion Criteria:

* \< 18 years of age
* Refusal to donate a blood sample
* Refusal to provide written informed consent and Authorization for Use/Disclosure of PHI
An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have Spread

The purpose of this study is to demonstrate the safety and preliminary activity with triple combinations of relatlimab in combination with nivolumab and BMS-986205, or in combination with nivolumab and ipilimumab in immunotherapy-naive and pretreated populations across select advanced tumor types.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic confirmation of select incurable solid malignancies that are advanced (metastatic and/or unresectable), with measurable disease per RECIST v1.1
* Available tumor tissue for biomarker analysis
* Eastern Cooperative Oncology Group Performance Status (ECOG) status of 0 or 1

Exclusion Criteria:

* Known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease
* History of interstitial lung disease / pneumonitis
* Prior malignancy active within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer
* Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent

Other protocol-defined inclusion/exclusion criteria apply
Developing a Non-invasive Cardiac Functional Health Status Measurement Device

This is a single-center, non-randomized study.Enrolled patients will be placed on a tilt table and a stress test will be performed in a total of 4 different positions. Their blood pressure will be measured at each position. Also, a pulse oximeter will be placed on the forehead to measure pulse rate and strength. These results will be compared to cardiac functional classifications defined by New York Heart Association (NYHA) criteria for adults and New York Pediatric Heart Failure (NYPHF) index for our pediatric age patients. The primary aim of this initiative is to assess the discriminatory value of a cardiac functional health classification based upon the degree of dependency of cardiac function on changes in cardiac preload and afterload circulatory volume.

Participants will be asked to review the informed consent and consent to the study prior to any study procedures. The study will consist of a single visit to the Medical Plaza at the University of Florida. During this visit, Enrolled patients will be placed on a tilt table and their position changed to a total of 4 different positions. Their blood pressure will be measured at each position. Also, a pulse oximeter will be placed on the forehead to measure pulse rate and strength. The study will take approximately 25 minutes. Data collected shall include a questionnaire for the patient, a list of the patient's co-morbidities, an echocardiogram or catheter lab data if available, and a list of the patient's current medications.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure patient eligibility shall consist of the following:

Group 1a: 5 adult heart transplant patients

* Age ≥ 21 years old and \<74 years old
* Speaks and understands English
* Provides Informed Consent

Group 1b: 5 pediatric heart transplant patients

* Age ≥ 7 years old and \< 21 years old
* Speaks and understands English
* Provides Informed Consent

Group 2: 5 adult heart failure patients

* Age ≥ 21 years old and \<74 years old
* Speaks and understands English
* Provides Informed Consent

Group 3: 5 adult aged Fontan patients

* Age ≥ 21 years old and \<74 years old
* Speaks and understands English
* Provides Informed Consent

Group 4: 5 pediatric Fontan patients

* Age ≥ 7 years old and \< 21 years old
* Speaks and understands English
* Provides Informed Consent

Group 5: 5 pediatric patients limited to heart murmurs

* Age ≥ 7 years old and \< 21 years old
* Speaks and understands English
* Provides Informed Consent

Group 6: 5 normal adult patients

* Age ≥ 21 years old and \<74 years old
* Speaks and understands English
* Provides Informed Consent

Exclusion Criteria:

* • Unstable patients per judgment of the clinician prior to the start of the treatment

  * Patients unable to have blood pressure cuff measured on the upper arm
  * Inability to wear monitor on forehead
  * Patients will be excluded from the study if they have eaten, consume caffeinated beverages, or taken hypertensive medications within 2 hours of testing
Effect of the COVID-19 Public Health Crisis on the Mental Health and Physical Well-Being of Cancer Patients, the Coping With COVID Study

This study determines how the threat of the coronavirus has affected the mental health and physical well-being of cancer patients seen at the psychiatric oncology clinic, and how they have coped with any related stress. Questionnaires that assess coping strategies and behaviors for decreasing disease transmission may help researchers create recommendations for future public health crises and pandemics.

PRIMARY OBJECTIVE:

I. To determine how the coronavirus disease 2019 (COVID-19) public health crisis affected mental well-being in cancer patients seen at the psychiatric oncology clinic.

SECONDARY OBJECTIVES:

I. To determine how the COVID-19 public health crisis affected physical well-being and substance use in cancer patients seen at the psychiatric oncology clinic.

II. To determine how patient coping strategies and levels of apathy affected mental and physical health symptoms and substance use during COVID-19 in patients seen at the psychiatric oncology clinic.

III. To determine the association of coping strategies and levels of apathy with proclivity to engage in health behaviors intended to decrease the transmission of the disease during the COVID-19 pandemic in patients seen at the psychiatric oncology clinic.

OUTLINE:

Patients complete 3 questionnaires online over 15 minutes regarding coping strategies that may have been used, mental health and physical well-being in the past month, and if they have been following certain behaviors which the World Health Organization (WHO) has recommended during the coronavirus pandemic, such as regular hand washing and social distancing.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients seen by providers of the psychiatric oncology clinic at least once between November 1, 2019 and February 29, 2020 and at least once between April 10, 2020 and June 10, 2020
* Speaking English as indicated in their medical chart

Exclusion Criteria:

* Patients who are pregnant as recorded in their medical chart
* Incarcerated
* With a recorded diagnosis of a formal thought disorder
* Unable to consent
Dual-Plane Breast Augmentation: Axillary Approach With Assistant of Endoscope

The purpose of this study is to evaluate the feasibility and outcome of performing dual plane breast augmentation with assistant of endoscope by axillary approach.

Dual plane augmentation mammoplasty is a logical approach to realize the benefits of retromammary and partial retropectoral implant placement while minimizing the tradeoffs of other pocket locations. Traditionally, dual plane augmentation has been performed using transareolar or inframammary fold approach. However, the approach is unacceptable to Chinese patients because of the front scar formation. For aesthetic reasons, the axillary incision is more acceptable approach for augmentation mammoplasty.

The endoscope assistant technique has been widely used in transaxillary breast augmentation. It provides the feasibility to perform dual plane breast augmentation by axillary approach.

In this research, at least 40 patients with light degree of glandular ptotic and constricted lower pole breasts are selected to receive soft cohesive gel microtextured anatomic style silicone implants. Portions of the pectoralis major muscle is split without its release from the costal margin with the help of a 10mm, 30°endoscope and endoscopic diathermy scissors through a 4-cm incision in the axilla each side. Bleeding during surgery is kept to the minimum. The results of outcomes, operative time, bleeding volume, drainage volume, complications are observed.

Eligibility Criteria:
Inclusion Criteria:

* All women who want breast augmentation using the implants.Especially for the patients with
* glandular ptotic (\< I degree) breasts
* thick soft tissues (\> 10 mm) in the low pole of the breast

Exclusion Criteria:

* With thin soft tissues (\< 9 mm) in the low pole of the breast
Crizotinib Plus Pembrolizumab In Alk-Positive Advanced Non Small Cell Lung Cancer Patients

The purpose of this study has 2 phases, a Dose Finding Phase will determine the maximum tolerated dose . The Dose Expansion Phase will explore the safety, tolerability, and anti-tumor activity of the combination.

The patients will be screened for up to 28 days before they start treatment to determine if they meet eligibility criteria. The screening procedures will include physical examination, blood work and radiological scans.

In the dose finding phase, patients who meet eligibility criteria will receive crizotinib at the dose level assigned that will be taken on daily basis and pembrolizumab 200 mg intravenous infusion every 3 weeks.

Once a Crizotinib dose level is decided, the dose expansion cohort will start enrolling patients who meet eligibility criteria.

All patients will be followed up every three weeks. Blood samples will be drawn to test for safety and tumor activities and radiological scans will be performed on certain timepoints to determine the antitumor activities.

There will be a quality of life questionnaire administered at certain time points during the study.

The study will have a quality assurance plan that addresses data validation and registry procedures. There is a plan to visit the investigator site for routine monitoring and auditing.

The team will conduct source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (e.g., medical records, paper or electronic case report forms, or interactive voice response systems).

The study will also include a statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives of this study, as specified in the study protocol or statistical plan.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proved diagnosis of locally advanced recurrent or metastatic non-squamous NSCLC that is not suitable for local curative treatment.
* Alk-positive NSCLC as determined by a test that is approved or validated for use as a companion diagnostic test.
* No prior systemic therapy for metastatic disease.
* Adjuvant chemotherapy more than 12 months prior to study enrollment.
* Measurable disease as per RECIST 1.1
* ECOG PS 0 or 1.

Exclusion Criteria:

* Prior exposure to ALK receptor tyrosine kinase inhibitor, anti-PD1, anti-PDL1 or any drug targeting T-cell checkpoint pathways.
* known diagnosis of immunodeficiency or is receiving systemic steroid therapy or other form of immunosuppressive therapy within 7 days of clinical trial treatment.
* Active autoimmune disease that has required systemic treatment in the past 3 months.
* History of extensive disseminated interstitial fibrosis or any grade of interstitial lung disease.
A Study of Circulating Immune Cell Activity Changes in Blood of Colorectal Cancer Patients

Previous studies have shown that colorectal cancer patients' prognosis and overall survival was related with immune cell expression in patients' tissue. However, the circulating immune cell activity changes in patients' blood has few studies. The purpose of this study is to analyze the variation of circulating immune cell activity in colorectal patients' blood which is classed as clinical staging.

The patients were classed as clinical staging

1. Early (stage1+2) and Late(stage3+4)
2. regional lymph node metastasis
3. Distant metastasis
4. TNM stage

Eligibility Criteria:
Inclusion Criteria:

* patient who was planned to undergo colorectal cancer surgery.

Exclusion Criteria:

* age \< 20 years old
* history of hypersensitivity reaction in propofol or sevoflurane
* history of previous cancer
* patient with ongoing inflammation
The Study is an Oberservational Post-market Follow-up Program to Evaluate Long Term(5 Years) Safety of Mentor Breast Implants in Chinese Population.

The Mentor Post-Market Clinical Follow-Up Study is a multicenter observational study conducted in China. It aims to collect safety data on Mentor breast implants over a 5-year follow-up period in the Chinese population. In addition to safety data, the study will also gather information on postoperative pain and participant satisfaction levels. The objective is to explore customers' clinical experiences and use them as a reference for future product development. The study intends to enroll a minimum of 300 subjects per license, with participation from three or more medical institutions.


Eligibility Criteria:
Inclusion Criteria:

1. Women who have received Mentor breast implants per product instructions;
2. Participants must possess the ability to comprehend the study procedures, give consent for the use of their preoperative and surgical data, and agree to take part in postoperative follow-up assessments. Additionally, they should possess the necessary civil capacity, be capable of reading and writing, and willingly provide informed consent by signing the consent form.
3. Participants must be at least 22 years old at the time of their implantation surgery.

Exclusion Criteria:

* Not applicable
A Clinical Study on Pre-operative Intervention With Products During Aesthetic Medicine

This clinical trial aims to evaluate whether a 14-day pre-operative application of the test product (containing MLYAAT-1002®, a proprietary anti-aging complex) can mitigate skin discomfort during Fotona 4D laser therapy (Frac3 and Piano modes) by comparing clinical evaluation, skin attributes measurement and subject self-assessment.


Eligibility Criteria:
Inclusion Criteria:

* health females aged 35-60;
* subjects with rough dark, loose fine lines;
* no history of cosmetic allergies;
* subjects are willing to use the test serum on split-face for 28 days;
* subjects are willing to suffer the Fotona 4D treatment (Frac3 and Piano modes) on the face;
* subjects are willing to use the basic skincare products for 28 days, and acceptable for split-face use of the test products or the control product for 14 days;
* written informed consent and portrait right consent were obtained from all participants before study entry.

Exclusion Criteria:

* anyone who is pregnant, nursing an infant, or planning a pregnancy during the study;
* subjects with known allergies or sensitivities to the ingredients in any of the study products;
* any symptoms of facial flushing, erythema, papules, desquamation, or edema as evaluated by a physician prior to initial screening or Fotona4D Pro treatment;
* unhealed skin lesions;
* participated in any other clinical trial within one month;
* received facial skin treatments including but not limited to lasers, chemical peels, and dermal fillers within one month;
* taken/injected anti-allergy medication in the past one month;
* participants in other clinical trials at the same time;
* any subjects that the investigator considers ineligible.
Study of Oral RXDX-101 in Adult Patients With Locally Advanced or Metastatic Cancer Targeting NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations.

Entrectinib (RXDX-101) is an orally available inhibitor of the tyrosine kinases TrkA (coded by the gene NTRK1), TrkB (coded by the gene NTRK2), TrkC (coded by the gene NTRK3), ROS1 (coded by the gene ROS1), and ALK (coded by the gene ALK). Molecular alterations to one or more of these targets are present in several different tumor types, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC), prostate cancer, papillary thyroid cancer, pancreatic cancer, and neuroblastoma. Patients with locally advanced or metastatic cancer with a detectable molecular alteration in targets of interest may be eligible for enrollment.

Phase 1 will assess safety and tolerability of entrectinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and efficacy will be assessed in the dose expansion portion of the study.


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumors that have a NTRK1, NTRK2, NTRK3, ROS1, or ALK molecular alteration.
* Measurable disease according to RECIST version 1.1.
* Prior cancer therapy is allowed, including crizotinib, ceritinib, and investigational drugs.
* Prior radiotherapy is allowed
* Patients with controlled asymptomatic central nervous system involvement are allowed.
* Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
* Adult patients age 18 years or older.
* Life expectancy of at least 3 months.

Key Exclusion Criteria:

* Current participation in another therapeutic clinical trial.
* Prior treatment with entrectinib.
* History of prolonged QTc interval (e.g., repeated demonstration of a QTc interval \> 450 milliseconds).
* History of additional risk factors for torsade de pointes (e.g., family history of long QT syndrome).
* Known active infections (bacterial, fungal, viral including HIV positivity).
* Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.
* Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis.
* Peripheral neuropathy ≥ Grade 2.
Reading Stories to Premature Babies Reinforces Mother-baby Synchronies?

Observations of the early interactions between the infant and his parents highlighted the existence of rhythmic and reciprocal communications that serve as a basis for the mother-baby relationship and the emotional and cognitive development of the baby.

Observations of the early interactions between the infant and his parents highlighted the existence of rhythmic and reciprocal communications that serve as a basis for the mother-baby relationship and the emotional and cognitive development of the baby. In this study, the investigator proposes to focus on premature births (before 37 years) because prematurity disrupts the synchronization of these mother-baby communication. For several years, reading of stories and nursery rhymes has been used by the liaison child psychiatry team in the neonatal medicine and pediatric intensive care unit of the University Hospital of Amiens, as a therapeutic mediation tool allowing And support for parent-child interactions. Thus, it is desirable to explore the impact of reading stories and rhymes on mother-baby synchronies. The study is innovative because it simultaneously explores several fields: physiological, neuroendocrine, cognitive and psychic. A pilot study carried out in 2013 showed the feasibility of this exploration in the three protagonists of the interaction: mother, preterm baby and reader.

Eligibility Criteria:
Inclusion Criteria:

* A premature birth between 27 and 37 SA
* At the time of the transfers, the latter must be hospitalized in intensive care and extubated

Exclusion Criteria:

For the baby:

* an unstable medical condition
* Serious somatic complications
* genetic or neurological diseases
* a twin.

For the mother:

* an impossibility to understand and speak the French language
* a mental or cognitive pathology
* an addiction to alcohol or other psychoactive substances
* persons under guardianship or curatorship or deprived of their liberty by a judicial or administrative decision
Mirror Therapy Combined With Task- vs. Impairment-oriented Rehabilitation Program

The goal of this clinical trial is to examine the effects of mirror therapy combined with task- vs. Impairment-oriented rehabilitation programs as novel hybrid approaches in individuals with stroke. Participants will receive mirror therapy combined with the task-oriented rehabilitation program (MTT), mirror therapy combined with the impairment-oriented rehabilitation program (MTI), or task-oriented rehabilitation program combined with the impairment-oriented rehabilitation program (TI) 90 minutes per day, three days per week, for six weeks.


Eligibility Criteria:
Inclusion Criteria:

1. A first-ever unilateral stroke ≥3 months
2. Age between 20 and 80 years
3. Baseline Fugl-Meyer Assessment Upper Extremity (FMA-UE) score \>10
4. No severe spasticity in any joints of the affected arm
5. Ability to follow the instructions
6. No participation in other studies during the study period
7. Willingness to provide informed written consent.

Exclusion Criteria:

1. Serious medical problems or poor physical conditions that might be detrimental to study participation.