cyrilzakka/clinical-trials huggingface dataset:
Care.Coach Avatars for Improvement of Outcomes in Hospitalized Elders, Including Mitigation of Falls and Delirium: a Multi-Site Clinical Study

Through NINR project 1R44NR017842-01 which preceded the present study, the investigators enhanced the care.coach avatar platform to incorporate a robust suite of evidence-based protocols based on the Hospital Elder Life Program (HELP), and to leverage an integration with hospital-based electronic medical record (EMR) systems. In the present study, the investigators seek to validate the efficacy of the new avatar platform, as measured by reduction in falls, delirium, and patient sitter utilization. Also, the investigators seek to gather patient and outcomes data at a scale sufficient to begin developing machine learning algorithms for intelligent, automatic assignment of protocols to maximize patient engagement and clinical efficacy, and for intelligent, automatic screening of delirium to assist care teams in positive identification of delirium. Therefore, the present study comprises a two-year randomized between-groups comparison across multiple hospitals to compare outcomes with the new generation of care.coach avatars as the intervention versus usual care only as the control. Each study group will be geographically distributed across participating research sites: initially MediSys Health Network's Jamaica Hospital Medical Center in New York, with additional hospitals to join the study over the course of two years.


Eligibility Criteria:
Inclusion Criteria:

* fall/delirium risk (may be based purely on age at the election of each site, e.g. 65+)

Exclusion Criteria:

* aggression or combativeness with intent to harm self or others
* severe hearing impairment and simultaneous severe vision impairment, despite assistive devices
* no comprehension of either Spanish or English
PortoSinusoidal Vascular Diseases and Systemic Sclerosis

Porto-Sinusoidal Vascular Disorders (PSVD) is a heterogeneous clinico-pathological entity characterized by alterations in small liver vessels. "Nodular regenerative hyperplasia (NRH)" is the most common PSVD. The most frequent liver disease associated with Systemic sclerosis (SSc) is primary biliary cholangitis reported in 2 to 22% of cases. NRH prevalence estimated to 1.4%, may be underestimated as NRH diagnosis is histologic and usually suspected in case of complications due to portal hypertension. Few data are available about NRH associated with SSc resulting in a lack of knowledge of the characteristics and outcome of these patients.

The study aims to compare the outcome of patients with MVPS associated with SSc to patients with MVPS without SSc. This work is a multicenter retrospective study comparing two groups of adult patients, one with MVPS associated with SSc and the other with MVPS without SSc. Patients with MVPS associated with SSc will be recruited from French university hospital departments of Hepatogastroenterology and Internal Medecine. Patients with MVPS without SSc will be recruited from the Beaujon Hospital database dedicated to liver vascular diseases.

Eligibility Criteria:
Inclusion Criteria:

* PSVD (Valdig criteria)
* SSC (ACR/EULAR 2013 criteria)

Exclusion Criteria:

* Liver cirrhosis
* Limited scleroderma
* Autoimmune hepatitis
* Primary biliary cholangitis
A Comparison of Two Brief Suicide Prevention Interventions Tailored for Youth on the Autism Spectrum

Rates of suicide have increased significantly over the past two decades, particularly among youth. Compared to the general population, autistic people are significantly more likely to think about suicide, attempt suicide, and die by suicide. Autistic individuals have identified suicide prevention as a top research priority; however, little is known about how to best help autistic youth at risk for suicide. The purpose of this study is to compare the effectiveness, feasibility, and acceptability of two suicide prevention strategies tailored for autistic individuals: the Safety Planning Intervention tailored for Autistic individuals (SPI-A) and SPI-A plus structured follow-up contacts (SPI-A+).

This study includes three aims:

Aim 1: Among autistic youth (age 12-24) at risk for suicide, compare the effectiveness of SPI-A vs. SPI-A+. The primary outcomes of interest are suicidal ideation (SI) and suicidal behavior (SB). Secondary patient-centered outcomes are mental health treatment initiation and engagement, quality of life, well-being, skills to manage SI, access to lethal means, safety plan use, and acute care services for suicidality.

Aim 2: Compare implementation outcomes of acceptability and feasibility for the two interventions from the perspectives of patients, clinicians, and health system administrators.

Aim 3: Explore patient characteristics that may moderate the relationship between intervention and SI and SB.

Eligibility Criteria:
Patient Participants

Inclusion Criteria:

* 12-24 years old
* Able and willing to provide informed consent (age ≥18) or assent and parental consent (age \<18)
* Able to speak English
* Have received a safety plan tailored for autistic youth during a clinical visit

Exclusion Criteria:

* Altered mental status that precludes ability to provide informed assent or consent (acute psychosis, intoxication, or mania)

Clinician Participants

Inclusion Criteria:

* Employment as a provider serving autistic patients at one of the study sites
* Employment in a role that involves suicide risk intervention with youth patients at a participating clinic
* Able to read and speak English
* Able and willing to provide informed consent
* 18-99 years old

Exclusion Criteria:

* There are no exclusion criteria for the clinician participants

Health System Leader Participants

Inclusion Criteria:

* Health system or clinic leader at one of the study sites
* Employed in a role that provides administrative oversight to clinicians conducting safety plans with patients
* Able to read and speak English
* Able and willing to provide informed consent
* 18-99 years old

Exclusion Criteria:

* There are no exclusion criteria for the health system leader participants
Immunization of HLA-A201 Patients With Metastatic Melanoma Using a Combination of Immunodominant Peptides From Three Melanoma Antigens, MART-1, GP100 and Tyrosinase

This is a study of a melanoma tumor antigen peptide vaccine. Peptides representing HLA-A201 restricted T cell epitopes of the melanoma antigens, MART-1, gp100 and tyrosinase will be administered emulsified in Incomplete Freund's Adjuvant, (IFA) to HLA-A201 patients with melanoma. The study is designed to evaluate the potential therapeutic role, immunologic effects and toxicity of repeated doses of this peptide vaccine administered subcutaneously.

Immune reactivity to the peptide epitope will be monitored in all patients by analysis of melanoma-specific T cell precursors prior to and after immunization.

This is a study of a melanoma tumor antigen peptide vaccine. Peptides representing HLA-A201 restricted T cell epitopes of the melanoma antigens, MART-1, gp100 and tyrosinase will be administered emulsified in Incomplete Freund's Adjuvant, (IFA) to HLA-A201 patients with melanoma. The study is designed to evaluate the potential therapeutic role, immunologic effects and toxicity of repeated doses of this peptide vaccine administered subcutaneously.

Immune reactivity to the peptide epitope will be monitored in all patients by analysis of melanoma-specific T cell precursors prior to and after immunization.

Eligibility Criteria:
Any patient 16 years of age or older with measurable metastatic melanoma who has failed standard treatment and has an expected survival of greater than three months.

Must be HLA-A0201.

Serum creatinine of 2.0 mg/dl or less.

Bilirubin 1.6 mg/dl or less.

WBC 3000/mm(3) or greater.

Platelet count 90,000 mm(3) or greater.

Serum AST/ALT less then two times normal.

ECOG performance status of 0 or 1.

Patients of both genders must be willing to practice effective birth control during the trial.

Must not be undergoing or have undergone in the past 3 weeks any other form of therapy except surgery for their cancer.

Must not have active systemic infections, coagulation disorders, or other major medical illnesses of the cardiovascular or respiratory systems or any known immunodeficiency disease.

Must not require steroid therapy.

Must not be pregnant.

Must not be positive for hepatitis B(s)AG or HIV antibody.

Must not have had a known allergic reaction to Incomplete Freund's Adjuvant (IFA).
Efficacy & Safety Comparison of Epiduo With Doxycycline Versus Vehicle With Isotretinoin in the Treatment of Severe Acne

Non-inferiority, randomized, controlled, multi-center, investigator-blind, parallel-group comparison study in subjects with severe acne vulgaris on the face.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subject of any race, aged 12 to 35 years inclusive
2. Subject weighing between 50 and 110 kg
3. Subject with severe acne (IGA at least 4), which in the opinion of the investigator is appropriate for treatment with oral isotretinoin (severe nodular acne, severe inflammatory acne, recalcitrant acne; all unresponsive to conventional first line therapies)
4. Subject with at least 5 nodules on the face

Exclusion Criteria:

1. Subject with clinically abnormal results to blood testings performed at screening
2. Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), pyoderma faciale, sinus tracks
3. Female subject who is pregnant, nursing or planning a pregnancy during the study
4. Subject with known history of hepatic and/or renal insufficiency, to be confirmed by blood testings
5. Subject with known metabolic or structural bone disease (for 12-17 years old population)
6. Subject with bowel disease and/or with hypervitaminosis A
7. Subject who presents with treated or untreated depression or has a history of depression including a family history of major depression
8. Subject with a wash-out period from baseline for topical treatment on the face less than : Corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatments (2 weeks); Cosmetic procedures (1 week); Photodynamic therapy and laser therapy for acne (3 months)
9. Subject with a wash-out period from baseline for systemic treatment less than: Corticosteroids, antibiotics (4 weeks),Progesterone for contraception (3 months); Spironolactone(3 months); Other acne treatments (6 months);Cyproterone acetate(6 months)
Capnography During Percutaneous Transhepatic Cholangiodrainage (PTCD) (HepaBreath)

Capnography provides noninvasive monitoring of ventilation and can allow early recognition of altered respiration patterns and apnea. The aim of this prospective study was to compare the detection of apnea and the prediction of oxygen desaturation and hypoxemia by capnography versus clinical surveillance during procedural sedation for percutaneous transhepatic cholangiodrainage (PTCD).


Eligibility Criteria:
Inclusion Criteria:

* Age\>=18
* Scheduled for PTCD with midazolam and propofol sedation

Exclusion Criteria:

* age less than 18 years
* ASA class V
* allergy to narcotic drugs
* pregnancy
* pre-existing hypotension, bradycardia or hypoxemia
Surgical Transversus Abdominis Plane Block in Pediatric Patients

The objective of this study to determine the effect of surgical transversus abdominis plane block and local infiltration for postoperative pain control in major abdominal surgery compare with control group.

Most children experience postoperative pain after major abdominal surgery. They may have ineffective ventilation, following atelectasis and pneumonia if receive inadequate pain management. There are several methods used for pain relief such as epidural block, intravenous analgesia with local infiltration, transversus abdominis plane (TAP) block by ultrasound guided and surgical TAP block. Therefore, the investigators would like to compare the effectiveness of postoperative pain control with TAP block. However, TAP block in children need experience and ultrasound. The investigators decided to do surgical TAP block performing by inject from peritoneum point to skin instead.

Eligibility Criteria:
Inclusion Criteria:

1. Age \< 15 year
2. ASA I-III
3. Abdominal surgery : all upper abdomen and lower abdomen which would have midline incision
4. Elective surgery

Exclusion Criteria:

1. Allergic to Lidocaine or bupivacaine
2. Delayed development
3. Major abdominal surgery within 2 year
Dermacyd PH_DESILSTY_FR (Lactic Acid) - Acceptability - Stay on Frutal

Primary Objective:

To prove the safety of the gynecological formulation in normal conditions of use.


Eligibility Criteria:
Exclusion criteria:

* Integral vaginal mucosa in the product analysis region
* Use the same category of cosmetics products
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time

Exclusion criteria:

* Use of Anti-inflammatory, immunossupression or antihistaminics drugs
* Allergic or atopic history to cosmetics products
* Cutaneous active disease (local and/or general) in the evaluated area
* Disease which can cause immunosuppresion, such as diabetes, HIV
* Endocrinology pathology such as thyroid gland, ovary and adrenal gland
* Intensive solar exposure until 15 days before evaluation
* Gynecological treatment until four weeks before the study
* Other reason considered by the investigator as a reason for not being included.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure

This is a study whose focus is on understanding the clinical utility of rectal ultrastructure in detecting colonic neoplasm. The method uses Low-coherence Enhanced Backscattering Spectroscopy (LEBS).

The investigators use an optic probe which is a small device that uses light to assess the colon tissue. This probe will be used to identify subjects who do and do not have precancerous changes in the colon by capturing the light reflected back from the rectal wall and that will be assessed without the need for colonoscopy and bowel preparation (i.e unprepped). This device may detect early cancerous changes in colon tissue with higher accuracy than current tests.

Eligibility Criteria:
Inclusion Criteria:

- Subjects are eligible if they were scheduled for colonoscopy for colon cancer screening or surveillance

Exclusion Criteria:

* age \<50
* personal/family history of colonic neoplasia
* personal history of coagulopathy
* (retrospectively) failure to complete or inadequate colonoscopy
* any patients harboring non-pathoglocially normal rectum (i.e. presence of lesion, inflammation, polyp, adenomas at rectum)
The Effect of Relaxation Response Training on Declarative Memory and Salivary Cortisol in Older Adults

To evaluate whether a 5-week relaxation response intervention influences the learning, memory or attention of healthy older adults.


Eligibility Criteria:
Inclusion Criteria:

* 65 to 80 years od age
* No prior or current psychiatric or neurological condition.
* score above 24 on the Mini-Mental State Exam (MMSE)
Reversing Glucose and Lipid-mediated Vascular Dysfunction

The purpose of our study is to understand the extent to which the blood vessels are affected by glucose and fat (lipids) in lean healthy adults and if these changes in the blood vessels contribute to the development of high blood pressure.

Hypertension, obesity, and insulin resistance are associated with elevated muscle sympathetic nerve activity (MSNA), which is important for blood pressure regulation. The measurement of MSNA is safely performed in humans using the microneurographic technique that involves recording sympathetic nerve activity projecting to skeletal muscle using a small microelectrode at the peroneal nerve near the knee.

The health of your blood vessels will be tested in this study, in addition to the activity of the nerves that control the blood vessels. The function of the nerves and blood vessels can be diminished by high blood glucose and lipids, and we will test the ability of a well-known antioxidant, ascorbic acid (vitamin C), to restore the function of the nerves and blood vessels.

Eligibility Criteria:
Inclusion Criteria:

* Lean: BMI \< 25 kg/m
* Normal insulin sensitivity: (calculation based on fasting glucose and insulin concentrations in blood)
* Middle-aged: 18-79 years
* Blood pressure: \< 140 (systolic) and \< 90 mmHg (diastolic
* Weight stable (+/- 5 lbs) for the previous 3 months
* Participants must be willing and able to discontinue taking any vitamin C or E supplements or omega-3 fatty acids beginning 2 weeks prior.
* Able and willing to provide written informed consent

Exclusion Criteria:

* Diabetes mellitus Type I or Type II: fasting glucose \< 126 mg/dL and/or HbA1c \< 6.5%
* Current smoker or History of smoking in the past 3 months.
* Hyperlipidemia: Fasting triglycerides \< 250 mg/dL
* Hypertension: \>130/80 mmHg
* History of heart disease (e.g., myocardial infarction, stent, heart attack, stroke, heart failure, valvular heart disease, cardiomyopathy)
* History of vascular disease (e.g., bypass, stroke)
International Classification of Functioning, Disability and Health and Lower Extremity Orthoses in Cerebral Palsy

International Classification of Functioning, Disability and Health (ICF) is a coding system developed to describe the health status of individuals in a universal way. The increasingly common core sets are short forms of ICF categories that are specifically selected for diseases. The aim of this study is to investigate the relationship among the lower extremity orthoses commonly used in children with cerebral palsy (CP), body structure and functions, activity and participation level, and is to determine the relationship between clinical tests and ICF CP core set. For this purpose, a total of 75 children with ages between 3 and 18 will be divided into 3 groups, including using a walking orthosis, using a resting orthosis, and using both walking and resting orthoses. Children's muscle tone, joint limitation, gross motor functions, balance skills, activity and participation levels and quality of life will be assessed with the tests frequently used in the clinic separately and with the core set in a holistic framework.


Eligibility Criteria:
Inclusion Criteria:

* Being 3-18 age years old
* Having the diagnosis with cerebral palsy
* Being no Botulinum Toxin Application or no surgery for the last 6 months

Exclusion Criteria:

* If there is any other neurological or orthopedic problem other than cerebral palsy
Safety, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber

The purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal product in seasonal allergic rhinitis patients.


Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 to 65 years of age with a positive skin prick test with ragweed allergen

Exclusion Criteria:

* No active respiratory tract infection
The Life Style Patterns and the Development Trend of Chronic Diseases in Healthy and Sub-healthy Groups Were Analyzed by Using Data-mining Techniques

Used multi-year health examination member profile by multi-algorithms technology, to find comprehensive key hazard factors or important high-risk group components for metabolic syndrome and chronic kidney disease or more common chronic diseases.

The proportion of the population over the age of 65 in Taiwan reached 7.10% in 1993. After Taiwan became an 「aging country」, the originally slow growth of the elderly population (9.9% in 2006) started to increase, and it reached 14.05% in 2018, which was almost 2 times that in 1993. In addition, Taiwan formally became an 「aged country」as defined globally. According to the statistical data from the Ministry of the Interior and the data from the National Development Council, it is estimated that the population over the age of 65 is rapidly growing. It is expected that 6 years later (by 2026), the elderly population in Taiwan will exceed 20%. Taiwan will formally become the「super-aged country」as defined globally, with a population structure similar to that in Japan, South Korea, Singapore, and some European countries (Department of Statistics, 2018; National Development Council, 2019). In order to effectively prevent and treat chronic diseases of sub-health populations and develop health management prediction systems that have unlimited market opportunities and potentials, the author intends to extend the achievements of individual projects sponsored by the Ministry of Science and Technology in recent years. By multi-year complete health examination member profile, this project used multiple algorithms, such as Logistic regression (LR); Classification And Regression Trees (CART); Hierarchical Linear Modeling (HLM); Random forests (RF); Support-Vector Machines (SVM); eXtreme Gradient Boosting (xGBoost); Light Gradient Boosting Machine (LightGBM) and multiple analysis tools to explore the common potential health hazard variables of the sub-health population to establish a comprehensive assessment health management system that can detect chronic diseases early, the research results will be provided for reference in related fields.

Eligibility Criteria:
Inclusion Criteria:

* Continuously health screening twice or more in MJ health reports.
* Chronic kidney disease
* Metabolic syndrome
* Or more, common chronic diseases

Exclusion Criteria:

* Participants who have received clinical treatment
* Subjects of other related research diseases
Nuclear Magnetic Resonance for Embryo Ploidy Selection

This study aims to validate the embryo culture medium analysis by nuclear magnetic resonance spectroscopy, as a faster and less-costly alternative to preimplantation genetic test for aneuploidy which could significantly enhance embryo selection and the success rate of assisted reproductive technologies.

Assisted reproductive technologies (ART) refers to treatments used to assist people in achieving a pregnancy. Over the last years, ART have been developed with efforts to deliver a healthy baby. However, the selection of the embryo that most likely results in pregnancy remains a critical step in ART. Currently, this selection is based on morphological assessment of the embryos, but up to 70% of those embryos display an abnormal number of chromosomes. Preimplantation genetic test for aneuploidy (PGT-A) is used to assess the ploidy of embryos, although this is an invasive, expensive and time consuming technique. Alternatively, in order to predict the ploidy of pre-implantation embryos (euploidy vs aneuploidy), we suggest to characterise the metabolic profile of the embryo culture medium by Nuclear Magnetic Resonance (NMR), which is a non-invasive, low cost and fast technique.

The aim of this study is to assess whether, using multivariable analysis to all the collected NMR data, it is possible to identify a differential metabolic pattern between aneuploid and euploid embryos which could improve embryo selection.

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥18 and \<49 years old.
* Body Mass Index ≥18.5 Kg/m2 and \<30 Kg/m2.
* Planned for in vitro fertilization followed by preimplantation genetic test for aneuploidy.
* Oocytes retrieval and fertilization by intracytoplasmic sperm injection
* Six follicles over 14 mm on the day of the triggering. Gonadotropin-releasing hormone antagonist
* Signed and dated informed consent.

Exclusion Criteria:

* Previous history of poor ovarian response (\<4 oocytes retrieved) with a maximal dose of ovarian stimulation (≥300 IU/day).
* Presence of a medical condition which is known to affect assisted reproductive technologies outcome (e.g. thyroid dysfunction).
* Active female smoking.
* Current use of anti-depressants, anti-psychotics, steroids, antiepileptics or chemotherapy.
* Those unable to comprehend the investigational nature of the proposed study.