cyrilzakka/clinical-trials huggingface dataset:
Clinical Extension Study for Safety and Efficacy Evaluation of Cellavita-HD Administration in Huntington's Patients.

Cellavita-HD is a stem-cell therapy for Huntington's Disease. Open label, single treatment, extension study for long-term safety and efficacy evaluation of Cellavita-HD intravenous administration in Huntington's disease patients who participated of ADORE-DH trial.

This extension study will include the subjects who participated the study phase II for dose-response evaluation of Cellavita-HD intravenous administration in Huntington's disease patients (maximum 35 subjects). Because it is a extension study, with an open scenario, the subjects will receive the maximum dose tested in the last clinical trial (ADORE-DH), corresponding to 6 x 10\^6 cells/weight range for each treatment cycle planned. Throughout of 24 months, the subjects will receive total dose planned divided into three administrations per cycle (2 x 10\^6 cells/weight range), that each will occur every 30 days. The maintaining the effectiveness of intravenous administration of Cellavita-HD product over time on clinical progression Huntington's disease will be verified by comparing the UHDRS total score at the end of the 24th study month against baseline score. Secondary evidences of efficacy will be evaluated by through the data of functional state, total functional capacity, functional independence, psychiatric symptoms and cognition from UHDRS scale. Additionally, related data to clinical worsening, change of Body Mass Index (BMI), risk of suicide attempt and neurological image improvement will be evaluated. Safety evaluation will included the incidence and classification of the adverse events experienced by the subjects during the study.

Eligibility Criteria:
Inclusion Criteria:

1. Phase II study participants (ADORE-DH) who express interest in participating in the extension period and who may have significant clinical benefits (motor, cognitive, behavioral and functional capacity) at the Investigator's judged after intravenous application of the Cellavita-HD product;
2. Provide consent by signing in two copies of the Informed Consent Form;
3. Participant using an acceptable contraceptive method.

Exclusion Criteria:

1. History of malignant neoplasia;
2. Present any clinical and laboratory condition or comorbidity that, at the physician's judged, may endanger the health of the research participant and prevent him / her from being part of the extension study;
3. known hypersensitivity to the investigational product and / or products of bovine origin;
4. Research participant who has participated in clinical trial protocols in the last twelve (12) months, unless the Investigator believes that there may be direct benefit to it (Resolution CNS 251 of August 7, 1997, item III, sub-item J);
5. Pregnant or lactating participant;
6. In use or anticipated use of immunosuppressive drugs as well as any other drug in which the use is restricted to this research protocol.
Social Information Processing in Children: an ocUlo-pupillometric Tool for Standard Evaluation

The goal of this observational study is to identify behavioral and physiological markers of social alterations in Autism Spectrum Disorders compared to Typically Developping peers. This single-centre study plan to use eye tracking to evaluate social disorders in Autism Spectrum Disorders (ASD). The investigators will estimate oculometric and pupillometric indices as potential ASD biomarkers. The study will last 4 years and will be organized in two phases.

In a first phase (expected to last 12-16 months), after an experimental validation in typical adults, relevant oculometric and pupillometric indices will be identified in a typical population of children and in a clinically diagnosed population of ASD children.

In a second phase of the protocol (expected to last 32-36 months), biomarkers identified in the first phase will be tested on a larger population including other neurodevelopmental disorders.

Eligibility Criteria:
Inclusion Criteria:

Phase 1

All groups have these 2 criteria in common:

Free, informed and signed consent of both parents Enrolment in the social security system

The other criteria per group are as follows:

Group of adult subjects without ASD : Age between 18 and 50 years Group of children without ASD

* Age between 2 and 12 years
* Group of children with ASD Age between 2 and 12 years Conformity with the diagnostic criteria of ASD according to DSM-V, ICD-10 or ICD-11

Phase 2

* Group of children without TND : Age between 0 and 12 years
* Group of children with TND, or whose diagnosis is in progress (via PCO referral) :

Age between 0 and 12 years Conformity to the diagnostic criteria of TND

Exclusion Criteria:

Phase 1:

All groups have the 2 common exclusion criteria Known uncorrected visual pathologies Known personal neurological pathologies

And they have these criteria per group:

* Group of adult subjects without ASD: Subject under guardianship or trusteeship Diagnosis of ASD Group of children without ASD : Diagnosis of ASD
* Group of children with ASD ICD-10 diagnosis of PDD (Rett syndrome and Hayler syndrome) Phase 2
* Group of children without ASD : Diagnosis of ASD (confirmed or ongoing)
Pulse Oximetry Errors in Hospitalized Patients Across Varying Skin Pigmentation

This is a prospective observational study designed to quantify and understand errors in pulse oximetry in hospitalized patients in relation to their skin pigmentation. It is driven by three recent retrospective studies showing missed diagnosis of hypoxemia in patients across a spectrum of skin pigmentation, defined as blood SaO2 \<90% when their pulse oximeter reads 92% or greater.

This prospective study will overcome the limitations of earlier retrospective studies using three important study protocols:

1. precise time-matching paired blood gas samples to stable periods of pulse oximeter readings
2. objective quantification of skin pigmentation rather than using documented or self-reported race
3. collection of high quality pulse oximeter tracing data, and identifying potential mediators of discordance of noninvasive and invasive measurements such as low perfusion states.

The primary aim is to quantify the bias in SpO2 measurements across skin pigmentation groups in a real-world setting against the gold standard of invasive measurements of arterial blood oxygen saturation measurements across categories of skin pigmentation. These data are essential to addressing health equity and patient safety for people of all skin pigmentations.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* hospitalized and at high risk of hypoxemia, defined as saturations \< 90%,
* patients with arterial line in place for clinical purposes

Exclusion Criteria:

* Profound anemia, defined as hemoglobin \< 8 g/dl will preclude blood draws for research purposes
* Known pregnancy
* In custody of law enforcement officials
A Study on the Correlation Between Interleukin 28B Genotypes With Clinical and Demographic Characteristics in Treatment-Naïve and Treatment-Experienced Patients With Chronic Hepatitis C

This multicenter study will evaluate the correlation of interleukin 28B (IL28B) genotypes with disease characteristics and demographics in treatment-naïve and treatment-experienced chronic hepatitis C patients, including patients with HIV co-infection. There will be a single study visit for testing.


Eligibility Criteria:
Inclusion Criteria:

* Adult (according to local legislation) male or female patient
* Chronic hepatitis C (CHC)
* Patients naïve to CHC treatment or patients who received prior interferon-based therapy for CHC for whom data on treatment received and treatment outcome is available; information on fibrosis stage prior to previous treatment is also required

Exclusion Criteria:

* Co-infection with hepatitis B
* History or evidence of decompensated liver disease
* History of major organ transplantation with an existing functional graft (including liver transplantation)
* End stage renal disease
Is Interval Appendectomy Necessary?

Appendicitis is one of the most common surgical problems in children, with 20-35% of patients having perforated by the time they present to a doctor. In these cases, the patient is often treated non-surgically with antibiotics. Once a patient has improved, it is not known whether it is better to perform an interval appendectomy (IA) or to continue a watchful waiting approach. The purpose of this trial is to determine if expectant nonoperative management (watchful waiting) is not inferior compared to IA management after successful conservative treatment of appendiceal mass at admission.


Eligibility Criteria:
Inclusion Criteria:

* Under 18 years of age
* Perforated appendicitis where the treating physician chooses to follow the conservative approach rather than performing an immediate appendectomy

Exclusion Criteria:

* Uncertainty about the diagnosis
* The need for laparotomy/laparoscopy for another reason
* Perforated appendicitis with diffuse abdominal fluid on imaging associated with a clinical picture of severe sepsis
* Another medical condition that may affect the decision to operate e.g., inflammatory bowel disease
* A comorbidity or chronic illness that contraindicates the watchful waiting approach, e.g, diabetes or cardiac problems
Remote Monitoring of Patients With CHF in Central Greece

The purpose of this study is to evaluate whether telemonitoring of patients with chronic heart failure produces a reduction in the combined end point of all cause mortality and number of hospitalisations, and whether it improves health related quality of life. In addition, the trials evaluate the economic and organisational impact of the telemonitoring service and examine its acceptability by patients and health professionals.

The purpose of this study is to the evaluate the use of a mobile and PSTN phone-based telehealth platform will be able to produce a reduction in the combined end point of all cause mortality, will have positive or negative impact in their generic and disease specific quality of life , or their specific activity compared with usual care. Following this; it is also hypothesized that this will also lead to a change in overall risk for CHF complications. In addition the patients' satisfaction using the telemedicine service will be studied. A Cost-Effective Analysis and Cost Utility Analysis will evaluate the tele-health service compared with the usual care from the health and social perspective.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years.
* Discharge from hospital after acute heart failure in the previous 3 months and FE \< 40% or FE \> 40% plus BNP \> 400 (or plus NT-proBNP\>1500) during hospitalization

Exclusion Criteria:

* Comorbidities prevalent on CHF with life expectation \< 12 months.
* Inability to use the equipment and help at home not available.
* Myocardial infarction or percutaneous coronary intervention in the last 3 months.
* Coronary artery bypass, valve substitution or correction in the last 6 months or scheduled.
* Being on waiting list for heart transplantation.
* Being enrolled in other trial.
NTRK Gene Fusion - Positive Advanced or Recurrent Solid Tumors, a Rare Cancer Caused by Specific Changes in the Genes

Researchers want to learn more about the use of larotrectinib as a real-world treatment for tropomyosin receptor kinase fusion cancer, also called TRK fusion cancer.

In people with TRK fusion cancer, a gene called neurotrophic TRK, (NTRK) joins or "fuses" with another gene. This creates a protein known as a fusion protein, which can cause cancer cells to grow. The study treatment, larotrectinib, is already available for doctors to prescribe to patients with TRK fusion cancer. Larotrectinib works by blocking TRK genes in cancer cells which helps stop the cancer from growing.

In this study, the researchers want to learn more about the safety and effectiveness of larotrectinib in adults and children with advanced or recurrent TRK fusion cancer. This means that their cancer has spread from where it started to other areas of the body, or the cancer has come back after a period of time. To answer this question, the researchers will collect information from patients who are taking larotrectinib as prescribed by their doctors. The researchers will learn what adverse events the patients are having. An adverse event is any medical problem that a patient has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

The study will include patients of all ages with TRK fusion cancer.

In this study, there will be no required tests or visits to a study site. Instead, the researchers will collect information from:

* the patients' medical records
* interviews with the patients or their parents or guardians
* the patients' visits to their doctor as part of their usual care The researchers will collect information about the adults for up to about 2 years and about the children for up to about 8 years.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are treated with larotrectinib or decided to be treated with larotrectinib, under routine clinical practice.

Exclusion Criteria:

* Participation in an investigational program with interventions outside of routine clinical practice
Comparison Between Land-based and Water-based Exercises for Knee Osteoarthritis: Randomized Controlled Trial

Forty six patients with knee osteoarthritis will be randomly allocated into two groups: water-based exercises and land-based exercises. Both of them will receive a strengthening exercise protocol for lower limb muscles. A blind investigator will assess the patients before and immediately after, 3 months and 6 months following the interventions. The main outcomes will be pain, function and strength.

Forty six patients with knee osteoarthritis will be randomly allocated into two groups: water-based exercises and land-based exercises. Both of them will receive a strengthening exercise protocol for lower limb muscles. A blind investigator will assess the patients before and immediately after, 3 months and 6 months following the interventions. The main outcomes will be pain, function, physical performance and strength.

Eligibility Criteria:
Inclusion Criteria:

* Moderate knee osteoarthritis (grade 2 or 3 using the Kellgren-Lawrence radiograph classification), diagnosed based on clinical and radiological criteria of the American College of Rheumatology
* No other lower limb and spine musculoskeletal disorders
* Independent gait
* Body mass index below 32
* Minimum of 4 points in the pain numeric rating scale during climb and descend stairs activities

Exclusion Criteria:

* Cognitive or psychological disorders
* Neurological disorders
* History of post-traumatic knee osteoarthritis
* Knee pain at least 12 months
* Prior surgery of the lower limbs or spine
* Fibromyalgia
* Rheumatoid arthritis
* Cardiovascular disease
* Participating in exercise programs and received treatment for the knee at least 3 months
Effects of Fimasartan on Insulin Secretion in Type 2 Diabetic Patients

This study was designed to evaluate the effect of ARB in improving insulin secretion in patients with type 2 diabetes. The investigators also aimed to evaluate if there are potential synergisms between ARB and DPP4 inhibitors in improving insulin secretion and urinary albumin secretion in diabetic patients.

Angiotensin II has been reported to insulin secretion in beta cells. Angiotensin II indirectly improves insulin secretion in beta cells via vasoconstriction and reduced islet blood flow. Chronic exposure to high glucose or high fat increases expression of AT1R (angiotensin type 1 receptor), leading to reactive oxidative stresses, inflammation, and apoptosis in beta cells, finally decreased insulin formation and secretion. Some studies showed the beneficial effect of blocking AT1R on insulin secretion and beta cell proliferation in animal models using angiotensin receptor blocker (ARB). Furthermore, 26 weeks of valsartan treatment improved insulin secretion in humans with impaired glucose regulation.

Eligibility Criteria:
Inclusion Criteria:

* Aged 20\~80 years
* Type 2 diabetic patients diagnosed more than 6 months ago
* HbA1c ≤8.5% at screening
* No change of OAD within the 3 months before screening
* SBP \<140 mmHg and DBP \<90 mmHg with anti-hypertensive drug at screening
* SBP ≥140 mmHg or DBP ≥80 mmHg without anti-hypertensive drug at screening

Exclusion Criteria:

* Type 1 diabetic patients or active insulin treatment at screening
* Treatment with ARB or ACEi within 1 month prior to screening
* Uncontrolled hypertension with SBP \>170 mmHg or DBP \>100 mmHg
* Pregnancy or lactation
* Elevated liver enzyme (AST or ALT \> 3 times the UNL) or elevated serum Cr (≥1.5 mg/dL in men and 1.4 mg/dL in women)
High-activity Natural Killer Immunotherapy for Small Metastases of Melanoma

The aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of melanoma.

By enrolling patients with small metastases of melanoma adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of high-activity natural killer cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 2 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Validation of 'Corona-T-test' for Assessment of SARS-COV-2-specific T-cell Response After COVID-19 or Vaccination

Accuracy validation of the designed and manufactured ELISpot-based in vitro diagnostic 'Corona-T-test' for detection of SARS-CoV-2-specific T cells.

The investigators enrolled three independent cohorts of vaccinated (n = 69), convalescent (n = 50), and healthy but unvaccinated individuals (n = 101). Further, they estimated the T cell response to the designed peptide antigen panel, as measured by the manufactured ELISpot-based in vitro diagnostic 'Corona-T-test' to detect SARS-CoV-2-specific T cells.

Eligibility Criteria:
Non-specific inclusion criteria

* Participants aged 18 and above
* Participants agreeing to follow the study procedures
* Participants able to understand the purpose, nature, and methodology of the study
* Participants having signed the informed consent

Healthy donors inclusion criteria

* No self-reported COVID-19 infection
* No vaccination against COVID-19
* No immunoglobulin (Ig) IgM or IgG antibodies against SARS-CoV-2 by three tests (IgM to SARS-CoV-2 detection: "SARS-CoV-2-IgМ-ELISA-BEST", Ref #D-5502, IgG to SARS-CoV-2 S protein detection: "SARS-CoV-2-IgG-quantity-ELISA-BEST", "Vector-Best", Ref #D-5505), IgG to SARS-CoV-2 N protein detection: "SARS-CoV-2 IgG Reagent Kit", ARCHITECT, Abbott Laboratories, EU)

Convalescents inclusion criteria

* Self-reported COVID-19 infection
* PCR confirmed COVID-19 in a period 14-45 days before recruitment
* Detectable IgG antibodies against SARS-CoV-2 (IgG to RBD domain of SARS-CoV-2 S protein detection: "SARS-CoV-2-IgG-ELISA", "National Medical Research Center for Hematology", Moscow, Russia. Ref #K153G)

Vaccinated inclusion criteria

* SARS-CoV-2 vaccination with 'Sputnik V' (Gam-COVID-Vac) in a period 7-14 days after the second vaccination before recruitment
* Detectable IgG antibodies against SARS-CoV-2 (IgG to receptor-binding domain (RBD) domain of SARS-CoV-2 S protein: "SARS-CoV-2-IgG-ELISA", "National Medical Research Center for Hematology", Moscow, Russia. Ref #K153G)

Exclusion criteria

- Age under 18 y.o.
Compression Anastomosis Using the CAR™ 27

Purpose: Evaluation of the CAR™ 27 for the creation of compression anastomoses. Indication: Compression Anastomosis Ring (CAR™ 27) device for creation of circular anastomoses during colonic or colorectal resection.

Study Design: Prospective, open labeled study. Patient Population: Male or female subjects 18 years of age or older who are scheduled for non emergency laparoscopic or open colonic or colorectal resections. A temporary loop ileostomy/colostomy can be preformed up to the discretion of the surgeon.

No. of Subjects: 15 patients estimated up to three months to enroll. Duration of Treatment: During the operation - creation of the anastomosis. Duration of Follow-up: Follow-up evaluation will be performed daily while hospitalized, during a post-op clinic visit at approximately 1 month (30 days ± 5 days) including a proctoscopic exam and by phone after 3 months.

Endpoints: To evaluate the creation of a safe and functioning anastomosis and the occurrence of adverse events related to the use of the CAR™ 27 device.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is over 18 years old.
2. Patient is scheduled for a non-emergency procedure.
3. Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.

Exclusion Criteria:

1. Patient has an allergy to nickel.
2. Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease.
3. Patient is participating in another clinical trial which may affect this study's outcomes.
4. Patient has been taking regular steroid medication.
5. Patient has contraindications to general anesthesia.
6. Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.
Prevention Among Young People With Intellectual Disability

This study aims to evaluate an intervention using the Toolkit "Children - what does it involve?" and the "Real-Care-Baby" (RCB) simulator among students with intellectual disability (ID), using a cluster randomized trial design with waiting-list control group.

Background: There is limited knowledge about how young people with ID can be facilitated in their process of deciding about parenthood. A feasibility study showed that it is possible to evaluate an intervention using the chosen instruments among students with ID in order to provide them with further insights about parenthood. Methods: Randomization of eleven clusters/schools to intervention and eleven clusters to waiting-list control. Intervention includes thirteen educational lessons and a three-day and night caring-session with the RCB simulator. Intervention will be given 1-2 lessons/week during 8-14 weeks. Data will be collected with questionnaires and interviews before and after intervention. In control group: Before and after waiting-list time and after intervention.

Eligibility Criteria:
Inclusion Criteria:

* Students with mild or moderate ID with informed consent can be included
* Understand and respond to a questionnaire

Exclusion Criteria:

- Students with severe ID