cyrilzakka/clinical-trials huggingface dataset:
Valuation of Quality of Life in Children With Asthma

The aim of the study is valuation of quality of life (QL) in children with asthma and analysis of the factors that can have influence on it. The clinical problems included into the aim are to evaluate:

* the correlation between the QL and asthma control
* the utility of the Polish Version of PAQLQ(S) by Juniper, especially the understanding of each question and it's answers The results of this study can be very helpful in the future in developing a questionnaires to use in Polish Primary Care, according to which the investigators would be able to see whether the asthma in our patients is being well controlled.

Quality of Life in people with asthma is strictly relevant with the correct treatment of the disease, that is why the correct screening of patient's quality of life, especially in children, is so important.

Exploring the quality of life (QL), we use different types of questionnaires to obtain a quantitative result, which we can interpret using a compatible key for it. Pediatric Asthma Quality of Life Questionnaire with Standardized Activities (PAQLQ(S)) by Juniper is a reliable measure of the influence of asthma on QL in children. The Polish Version of the questionnaire is a strict translation of the english one, however it is not completely validated, which in practice can evince in difficulties in understanding the meaning of the applied questions, probably because of the difference in the habits of both populations.

The aim of the study is valuation of quality of life (QL) in children with asthma and analysis of the factors that can have influence on it. The clinical problems included into the aim are to evaluate:

* the correlation between the QL and asthma control
* the utility of the Polish Version of PAQLQ(S) by Juniper, especially the understanding of each question and it's answers The results of this study can be very helpful in the future in developing a questionnaires to use in Polish Primary Care, according to which we would be able to see whether the asthma in our patients is being well controlled.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Asthma
* Asthma treatment at least 6 months before enrollment
* Must be able to do spirometry

Exclusion Criteria:

* Children during the introductory period of the specific immunotherapy
* Other protracted diseases
Doppler Findings in the Fetal Cerebral Blood Vessels (VA/MCA) Within 24 Hours Before Delivery and Relation With Perinatal Outcome.

1. Assess differences in flow patterns in the fetal cerebral blood vessels within 24 hours before delivery between fetuses with a normal vs. adverse perinatal outcome.
2. Explore maternal and/or fetal characteristics that might influence technical feasibility of doppler sonography of the fetal cerebral blood vessels in early labor at term.
3. Assess reliability of the technique by measuring intra- and inter-observer variation in a subset of participants.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy.
* Term gestation (37-42 weeks).
* Fetus in cephalic presentation.
* No known fetal chromosomal or (severe) congenital anomaly.
* Normally grown fetus (ultrasound scan demonstrating normal fetal growth between 30-37 weeks of gestation, defined as an estimated fetal weight/abdominal circumference \> 10th centile or crossing \<2 quartiles compared to earlier growth ultrasound).
* Absence of pre-existing doppler or amniotic fluid abnormalities.
* Normal fetal heart rate tracing / CTG (excluding pre-existing hypoxia).
* Admission in early spontaneous labor or induction of labor with expected delivery \< 24 hours.
* Maternal age \>= 18 years
* Willing to give written informed consent.

Exclusion Criteria:

* Advanced labor (\> 4cm of cervical dilatation) at the time of admission on the labor ward.
* Severe pre-existing chronic maternal medical condition or poor obstetric history/antenatal complications associated with increased risk of adverse perinatal outcome (non-exhaustive e.g.: uncontrolled chronic hypertension, severe pre-eclampsia, uncontrolled (gestational) diabetes, maternal sepsis, major antepartum haemorrhage, intra-uterine infection, prolonged rupture of membranes \> 18 hours, etc.).
* Intra-uterine fetal demise / death.
* Prelabour rupture of membranes with meconium-stained amniotic fluid.
* Patients not fulfilling all the inclusion criteria or refusing to give written informed consent.
A Trial to Investigate Hyperglycemic and Hypoglycemic Excursions in Subjects With Type 1 Diabetes

This is a single center, double-blind, randomized trial in subjects with type 1 diabetes mellitus applying an adaptive design approach.

Subjects were be studied on two occasions, in randomized sequence, whereby glycemic excursions are assessed following an oral mixed meal challenge while treated with either insulin alone or co-administered insulin and glucagon.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged between 18 and 64 years (both inclusive)
* Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months prior to the screening visit
* Treated with daily insulin for T1DM ≥ 12 months prior to the screening visit

Exclusion Criteria:

-
Interest of Virtual Reality to Reduce Patient Anxiety During the Placement of a Percutaneous Implantable Port Catheter

The Vascular Access Unit (UAV) of the Lyon Sud Hospital Center is the first unit within a French public establishment where the Regional Health Agency (ARS) has authorized that medical procedures for the installation of central venous access be performed by nurses.

The installation of CIP represents an anxiety-provoking step for the patient, because the gesture, which consists of inserting a box under the skin, connected to a catheter, placed in a deep vein, involves uncomfortable, even painful moments. In the UAV, the installation of this device is carried out in the operating room, without premedication and only under local anesthesia. Affected patients usually have a diagnosis of serious illness (oncology).

Virtual Reality (VR) simulates the physical presence of the patient in an environment artificially generated by software. Many applications have already been evaluated in different health sectors, the investigators would like to show its interest in reducing patient anxiety during CIP placement under local anesthesia, without premedication.

The medical device used is Lumeen. It is a Class I medical device software within the meaning of Regulation (EU) 2017/745, CE marked. In the context of research, the Relaxation module is used. This module is the one intended for the management of anxiety and pain induced by medical procedures in adults and children over 6 years of age. It allows to perform immersions in 360° videos in real shots or computer-generated images, accompanied by natural sounds, relaxing music and a relaxation script recorded by hypnotherapists. The duration of an immersion can be adjusted according to the needs of the medical procedure..


Eligibility Criteria:
Inclusion Criteria:

* Adult patient ≥18 years old
* Patient operated on an outpatient basis and available for a phone call between D+1 and D+5
* Patient operated for a 1st pose of CIP at the UAV
* Patient whose anxiety measured by ENS Anxiety is at least 4/10 at entry
* Patient having signed the Informed Consent
* Patient affiliated to a social security

Exclusion Criteria:

* Patient not sufficiently fluent in the French language, in the judgment of the investigator, to allow him a good understanding of the implementation and the interest of the virtual reality headset material;
* Patient with motion sickness;
* Patient participating in another study who, in the judgment of the investigator, could interfere with the results of this research protocol;
* Patient deprived of liberty or placed under guardianship or curators;
* Pregnant or breastfeeding women;
* Patient with a history of epilepsy ;
* Patient with a pacemaker or pacemaker;
* Patient with psychiatric disorders of a psychotic nature in the acute phase or visual hallucinations;
* Patient under anxiolytic treatment;
* Patient presenting wounds or infections on the level of the head not allowing the installation of the virtual reality helmet.
Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)

The purpose of this study is to test the safety and tolerability of repeated subcutaneous (SC) doses of belimumab in subjects with SLE.

This clinical trial will evaluate the safety, pharmacokinetics (PK), and effect on biomarkers of repeated subcutaneous (SC) administration of belimumab in subjects with SLE. As data permit, an exploratory pharmacodynamic analysis will be performed to evaluate the correlation between belimumab serum exposure, PGA, SELENA SELDAI, and biomarker effects.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria
* Active SLE disease
* On stable SLE treatment regimen

Exclusion Criteria:

* Pregnant or nursing
* Have received treatment with an B cell targeted therapy
* Have received treatment with a biologic investigational agent in the past year
* Have received intravenous (IV) cyclophosphamide within 180 days of Day 0
* Have severe lupus kidney disease
* Have active central nervous system (CNS) lupus
* Have required management of acute or chronic infections with the past 60 days
* Have current drug or alcohol abuse or dependence or within the past year
* Have a historically positive test or test positive at screening for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
* Have a history of an allergic or anaphylactic reaction to drugs, food, or insects requiring medical intervention
The Effect of Curcumin Supplementation on Recovery From Exercise-induced Muscle Damage

Recent evidence suggests that curcumin supplementation may reduce muscle inflammation, oxidative markers, and muscle damage. The most favourable dosage to elicit these ergogenic effects are yet to be established; both 750mg \& 1500mg has been shown to be effective. Curcumin supplementation has been ingested in numerous different ways however, no previous research to date has used curcumin in a hydrolysed (drinkable) format. The aim of this study is to investigate whether hydrolysed curcumin can reduce indices of muscle damage and improve recovery, whilst also examining a potential dose-response effect.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria are as follows:

* between the age of 18-35
* non-smoker
* no previous history of cardiovascular, respiratory, or neurological problems
* not taking anticoagulant medication
* injury-free in the 3 months prior to scheduled participation in the study

Exclusion Criteria:

Exclusion criteria include:

* hypertension (\<140/80)
* any blood diseases or clotting issues,
* injury, or previous injury in \<3 months
Eribulin Mesylate Combined With Lobaplatin in the Treatment of Recurrent or Metastatic Triple-negative Breast Cancer

A prospective phase II study conducted at the Cancer Hospital Chinese Academy of Medical Sciences to compare the effectiveness of eribulin combined with lobaplatin in the treatment of recurrent or metastatic triple-negative breast cancer

This study is designed to be a prospective phase II study conducted at the Cancer Hospital Chinese Academy of Medical Sciences. The target populations of this study are patients with recurrent or metastatic triple-negative breast cancer who received the therapy of eribulin combined with lobaplatin from July 1, 2020 to December 31, 2022. It is expected to enroll 40 subjects in this study. The subjects' data such as demographics and other baseline characteristics, medications, prognosis, will be collected, and statistical analysis of data will be conducted to compare the effectiveness outcome measures.

Eligibility Criteria:
Inclusion Criteria:

1. Female aged between 18 and 75
2. Recurrence or metastasis OF TNBC confirmed by histological or cytological methods, TNBC definitions of ER, PR and HER-2 are negative, if there is metastasis pathology, the histological pathology of metastasis shall prevail.ER and PR negative were defined as ER \< 10% positive and PR \< 10% positive.
3. Disease progression after at least one prior systemic treatment and anthracycline and/or taxane use;Note: For neoadjuvant/adjuvant therapy, recurrence or disease progression during treatment or within 6 months of discontinuation of treatment should be counted as first-line systemic treatment failure;
4. There should be at least one measurable lesion according to the efficacy evaluation criteria for solid tumors (RECIST version 1.1)

Exclusion Criteria:

1. The number of previous treatment lines (including postoperative adjuvant therapy) \<2 lines
2. symptomatic central system metastases. Patients with stable asymptomatic BMS who have received brain radiation and who have at least one other evaluable target in addition to the BMS can be enrolled (evaluable target should be at least 4 weeks away from the last radiotherapy).
3. New bisphosphonate or dinoselmer treatment for bone metastases was initiated within 28 days prior to study initiation.(Subjects are permitted if they have already been treated with bisphosphonate or dinoselmer for at least 4 weeks of optimal stable administration prior to study initiation.)Subjects already enrolled in this study may begin treatment with bisphosphonate or dinoselmer for bone metastases after the first post-treatment evaluation
A Real World Study of Apatinib in Treatment of Patients With Gastric Carcinoma

The study was designed to evaluate the efficacy and safety of apatinib in the treatment of patients with gastric carcinoma.

The study is a real-world non-interventional retrospective study and will collect the original medical records of patients with gastric carcinoma treated with apatinib from 2015 to 2018 in Henan Cancer Hospital. Clinical data such as patient demographic, history of treatments, tumor biological characteristics and adverse events will be analyzed to evaluate the efficacy and safety of apatinib and explore the risk factors of prognosis in patients with gastric carcinoma.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically or cytologically confirmed gastric or residual gastric or gastroesophageal junction carcinoma;
2. Patients received apatinib treatment at least once.

Exclusion Criteria:

1. No specific exclusion criteria in this real world study.
Zinc Absorption in Flakes Derived from Sprouted or Hydrothermally Processed Wheat

The aim of this project is to investigate whether the increased zinc bio-accessibility values in sprouted or hydrothermally processed wheat is reflected in an increased zinc absorption in human subjects after consuming breakfast flakes derived from such processed wheats.

The zinc study is a randomised crossover design with two different meals (control wheat flakes and flakes derived from sprouted wheat or flakes derived from hydrothermally processed wheat) spiked with a specific zinc isotope. The study contains two test groups (I and II) of 26 and 10 participants, respectively. Both test groups will consume the control wheat flakes, whereas test group I will consume the flakes from sprouted wheat and group II the flakes from hydrothermally processed wheat randomised over two test days. An intravenous dose of Zn will be given on day 1 of the study and the zinc isotope composition in the urine of the participants will be measured on day 1,5,6,7 and 8 of the study.

Eligibility Criteria:
Inclusion Criteria:

* BMI range 18.5-25.0 kg/m²
* Regular diet with 3 meals a day (at least 5 times a week)

Exclusion Criteria:

* Intake of vitamin and/or mineral supplements during and 2 weeks before the stud
* Intake of antibiotics 3 months prior to the study
* Intake of medicines that have an impact on the gastrointestinal tract during and 2 weeks before the study
* Previous or current gastrointestinal (e.g. Crohn's disease), endocrine or eating disorders or other gastrointestinal history
* Previous or current substance/alcohol dependence or abuse (\> 2 units per day/14 units per week)
* Currently smoking (have smoked in the last 28 days) or willingness to smoke during the study period
* Pregnant or lactating or wishing to become pregnant in the period of the study
* Allergy or intolerance to wheat (coeliac disease, gluten sensitivity) or citric acid
* Adherence to vegan or vegetarian diets or special diets (weight loss, gluten-free etc...)
* Blood donation in the 6 months prior to the study
Clinical Investigation and Molecular Forms of Family Disease of Varicose

The existence of a family factor in the genesis of varicose veins is certain, but few studies have addressed reliably instead of the genetic factor in clinical and molecular level. The investigator initiated an original study to identify one or more genetic abnormalities predisposing to varicose disease, based on a combined approach of genetic linkage and of exome sequencing. The clinical research phase is an essential prerequisite to the identification of genetic mutations; it is to identify large affected families and ensure an extremely rigorous and accurate phenotyping of individuals over several generations. A first clinical work has identified and / or phenotype 8 families with a genetically informative family suggesting autosomal dominant inheritance. Linkage analysis suggested several candidate chromosomal regions without allowing the identification of a gene. This project aims to resume and expand the Family clinical investigations and apply the techniques of genome analysis points, including exome sequencing on the most informative families to identify the genes and mechanisms responsible of this disease and improve the prevention and the treatment of varicose veins.


Eligibility Criteria:
Inclusion Criteria:

* Any patient consultant the Medicine Vascular Surgery for varicose veins of the lower limbs as part of a manifesto family context
* Varices Presence in at least one family member
* Written consent

Exclusion Criteria:

* Patients who are unable to sign or who refuse to sign an informed consent
* Subjects aged less than 25 years, due to the low penetrance of varicose disease that age.
* Secondary veins at a post-thrombotic disease (suspected by the examination and confirmed by Doppler ultrasonography of the deep venous system)
* Venous angiodysplasia or secondary varicose arteriovenous fistulas.
A Trial of the C-TraC Intervention for Dementia Patients

The goal of the project is to conduct a prospective, randomized-controlled clinical trial to determine the extent to which the Coordinated-Transitional Care (C-TraC) program impacts transitional care quality, patient cognition/function, caregiver stress and 30-day rehospitalizations in patients with documented diagnoses of dementia discharged from the hospital to the community.

Patients with dementia often experience poor quality transitions from the hospital to the community. In response, the investigators developed and piloted the Coordinated-Transitional Care (C-TraC) program--a low-cost, telephone-based intervention designed to improve care coordination and outcomes in hospitalized patients with dementia or other high-risk conditions discharged to community settings.

A single-blind, prospective, randomized-controlled trial will be used with participants being randomly assigned to receive usual (i.e. standard) care, or usual care plus the C-TraC intervention. Outcomes will be assessed via scheduled phone-calls at 14, 30, and 90 days post-hospitalization. A 45-day phone call will also be conducted to complete a brief satisfaction survey with the caregiver about their post-hospital experience.

Eligibility Criteria:
Patient Inclusion Criteria:

* English-speaking
* Have a working telephone
* Hospitalized on medical inpatient wards at UWHC
* A documented pre-hospitalization diagnosis of dementia.
* Alzheimer's Disease Cooperative Study - Clinical Dementia Rating (ADCS-CDR) score of \> 0
* Have a family member/informal caregiver who has regular contact with them in the community setting

Caregiver Inclusion Criteria:

* English-speaking
* Have a working telephone
* Have contact with patient a minimum of once per week

Patient Exclusion Criteria:

* Discharged to institutional settings
* No identified caregiver
* Discharged to hospice
* Followed by complex case management or any form of intensive case management (e.g. transplant, congestive heart failure, dialysis)
* Score moderate-high on modified ASSIST tool for alcohol
A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors

Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of AK112 (anti-PD-1 and VEGF bispecific antibody) combined with AK117#AntiCD47 Antibody# in advanced malignant tumors


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 75 years old.
2. Have a life expectancy of at least 3 months.
3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Phase Ib: Histologically or cytologically confirmed selected advanced solid tumor.
5. Phase II:

   Cohort 1 and 2 :

   A. Has histologically confirmed recurrent or metastatic HNSCC who had failed only first-line platinum-containing therapy.

   B. Has histologically confirmed recurrent or metastatic HNSCC with PD-L1 positive (CPS≥1) without prior systemic antitumor therapy.

   Cohort 3: Has histologically confirmed recurrent or metastatic HNSCC without prior systemic antitumor therapy.
6. Have at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.
7. Has adequate organ function.

Exclusion Criteria:

1. Undergone major surgery within 30 days prior to the first dose of study treatment.
2. Active central nervous system (CNS) metastases.
3. History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs).
4. Active Hepatitis B or Hepatitis C.
5. Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity.
6. History of severe bleeding tendency or coagulation disorder.