cyrilzakka/clinical-trials huggingface dataset:
Multiparametric Assessment of Peripheral Blood and Tissue Myeloid Cells. Phenotype for Precision Medicine in Patients With SARS-Cov-2 Infection

We hypothesise that patients with SARS-Cov-2 infection are characterized by progressive changes in distribution of distinct lung macrophages populations mediated by influx of circulating monocytes into the lungs . Moreover, we also hypothesise that patients with higher rate of MerTKpos alveolar macrophages in the lung lavage will have the lowest rate of lung complications and the best recovery outcome in terms of clinical outcome and need of assisted ventilation supporting the use of macrophage phenotyping as novel prognostic biomarker in patients with SARS-Cov-2 infection. Finally, the definition of the transcriptomic signature of peripheral blood and tissue-derived myeloid cell subtypes will offer new therapeutic target of this uncurable newly discovered infection.


Eligibility Criteria:
Inclusion Criteria:

- Patients with COVID-19 pneumonia

Exclusion Criteria:

* Other infections rather than Covid-19
* Patients with concomitant treatment with prednisone ≥10 mg daily
* Patients under therapy with immunosuppressants
Inflammation, Polyphenols, and Genetics

Pilot study to determine whether daily consumption of blackraspberry powder (high in polyphenols) can reduce markers of inflammation and to determine whether genetics influence baseline levels of inflammatory markers as well as individual's response to polyphenols. A total of 10 males participated in this cross-over study.

A high-fat, high-calorie challenge meal is administered to induce an inflammatory response in overweight and obese adult males. Serum levels of CRP, TNF-alpha, and IL-6 are measured prior to the challenge meal and at various times (1,2,4,8, and 12 hours) after the challenge meal. The challenge meal is given once without intervention and once after 5 daily doses of concentrated black-raspberry powder mixed in water.

Eligibility Criteria:
Inclusion Criteria:

* adult males over 55 years of age
* overweight or obese

Exclusion Criteria:

* history of adverse reaction to berries or berry products
* history of adverse reaction to high-fat, high-calorie challenge meal
* significant liver or renal insufficiency
* significant cognitive impairment
Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4)

A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis.

The study will compare multiple doses of aldafermin against placebo in a compensated NASH cirrhosis population for 48 weeks of treatment.

Eligibility Criteria:
Key Inclusion Criteria:

1. Liver biopsy consistent with NASH cirrhosis.
2. Compensated cirrhosis due to NASH.

Key Exclusion Criteria:

1. Other causes of liver disease including but not limited to alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders, primary biliary cirrhosis, drug-induced hepatotoxicity, Wilson's disease, hemochromatosis, and alpha-1-anti-trypsin definition based on medical history and/or centralized read of liver histology.
2. Evidence of drug induced steatohepatitis secondary to amiodarone, corticosteroids, estrogens, methotrexate, tetracycline, or other medications known to cause hepatic steatosis.
3. History of hepatic decompensation including variceal bleeding, ascites, or hepatic encephalopathy.
4. Model of end stage liver disease (MELD) score \>12.

Other protocol-defined inclusion/exclusion criteria could apply.
Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes

The primary aim of the study is to evaluate the glucose response to low-dose glucagon (single 150 µg dose) administered immediately before aerobic exercise in individuals with AHCL-treated T1D.

The study consists of a screening visit (visit A) and two additional study visits (visit B and visit C) completed in a sequential order. During study visit B participants will receive s.c. administration of 150 ug glucagon prior to a 45-min moderate intensity continuous exercise session and subsequently continue into a 1-hour post-exercise observation period. During study visit C the exact same procedures will be followed with the omission of glucagon.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Type 1 diabetes ≥ 2 years
* Use of AHCL system MiniMed 780G ≥ 4 weeks
* Use of Novorapid for ≥ 1 week

Exclusion Criteria:

* Allergies to lactose or glucagon
* Known or suspected allergies to glucagon or related products
* History of hypersensitivity or allergic reaction to glucagon or lactose
* Patients with diagnosed pheochromocytoma, insulinoma or gastroparesis
* Concomitant medical or psychological conditions identified through review of medical history, physical examination and clinical laboratory analysis that, according to the investigator's assessment, makes the individual unsuitable for study participation
* Lack of compliance with key study procedures at the discretion of the investigator
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (methods are considered adequate for study enrolment for females: an intrauterine device, hormonal contraception (birth control pills, implant, patch, vaginal ring or injection), a single partner who is sterile or infertile, or sexual abstinence. Contraception is required throughout the study duration. Sterilized or postmenopausal women (\>12 months since last period) are not required to use contraception)
* Inability to understand the individual information and to give informed consent
Prophylactic Negative Pressure Dressings for Closed Laparotomy Wounds - A Randomised, Controlled, Open Label Trial

Laparotomy wounds are associated with high rates of surgical site infections (SSI). The effect of prophylactic negative pressure dressing of closed incisional wounds on SSI rates is inconclusive.


Eligibility Criteria:
Inclusion Criteria:

* Elective and emergency abdominal surgery

Exclusion Criteria:

-
Combination of Fluoroscopy and Ultrasonography Guidance in Sacroiliac Joint Injections

The primary purpose of this study is to investigate the effect of the application of sacroiliac joint injection guided by combination of ultrasonography and fluoroscopy on the duration of the procedure and the amount of radiation exposed during the procedure, compared to the application of only fluoroscopy-guided technique. Secondary objectives are to evaluate the effectiveness of the treatment with both methods and to record the adverse events that may be encountered during the procedure.

The study was designed as prospective, randomized, controlled trial. The patients who meet the eligibility requirements will be randomized into two groups in a 1:1 ratio to fluoroscopy and ultrasound+fluoroscopy. Processing time will be recorded during injection. "Fluoroscopy time" (sec) and "kerma-area product" (μGy) automatically measured by the fluoroscopy device will be used to evaluate the radiation exposure. Pre-procedural visual analogue scale (VAS) scores and Oswestry Disability Index (ODI) values were noted all the patients.

Eligibility Criteria:
Inclusion Criteria:

* Low back and/or gluteal pain and/or groin pain without radicular extension below the L4 level for more than 3 months
* Pain score greater than 3 according to NRS
* Unresponsiveness to conservative treatment (such as exercise, NSAID)
* At least 3 of the five sacroiliac provocation tests (FABER (Patrick), thigh thrust, Gaenslen, sacroiliac compression, and sacroiliac distraction tests) are positive

Exclusion Criteria:

Refusing to participate in the study

* Pregnancy
* Infective sacroiliitis
* Malignancy
* Osteoporosis
* Mechanical lumbosacral pathologies (spondylolisthesis, scoliosis, stenosis, etc.)
* Neurological finding in the lower extremity
* Pain spreading below the knee
* History of spinal surgery
* History of allergy to drugs to be injected (local anesthetic, contrast material, steroid allergy)
Hydroxyurea in the Treatment of Sickle Cell Disease

This is a retrospective cohort study of Sickle Cell Disease (SCD) patients attending 32 treatment centers across Italy. The aim of this study will be to report the Italian experience with the use of hydroxyurea in a large cohort of SCD patients and to evaluate the benefits and safety of this intervention for the prevention and management of a wide range of clinical morbidities

The indication for hydroxyurea initiation was 2-3 vaso-occlusive crisis and/or hospitalizations in the last year.

The study will analyze demographics (age and gender), origin, genotype, clinical phenotype (vaso-occlusive or hemolytic), transfusion history (including exchange), and folic acid use, average laboratory values up to three years pre-hydroxyurea and for the period post-hydroxyurea therapy including total hemoglobin level, fetal hemoglobin level, hemoglobin S level, white blood count, platelet count, lactate dehydrogenase level, total and direct bilirubin levels, aspartate and alanine aminotransferase levels, and serum creatinine level.

The incidence of complications pre- and post-hydroxyurea therapy will be also analyzed including: stroke, silent cerebral infraction, acute chest syndrome, vaso-occlusive crisis, hospitalization, pulmonary hypertension, leg ulcers, bone necrosis, and kidney injury. Safety data included adverse events as reported by the treating physician and the incidence of malignancy or death as well as pregnancy incidents and their outcomes will be also pointed out.

Eligibility Criteria:
Inclusion Criteria:

* Sickle Cell Disease affected patients
* 2-3 vaso-occlusive crisis and/or hospitalizations in the last year

Exclusion Criteria

* none
Detection of Eating Disorders in Pregnant Women

Eating disorders (ED) are insufficiently detected and belatedly or not treated during pregnancy.

There are many screening questionnaires for eating disorders in the literature, but we note the absence of a specific and validated tool for their screening during pregnancy, which would make it possible to differentiate maternal dietary concerns related to pregnancy from symptoms linked to a proven eating disorder.

The main objective of the study is to evaluate which items of the Sick Control One stone Fat Food (SCOFF-F) and Eating disorders examination questionnaire (EDE-Q) questionnaires could be specific to an ED during pregnancy and not related to the simple state of pregnancy, by comparing the answers of pregnant women, for whom the diagnosis of ED has been made, to those of pregnant women without an ED.


Eligibility Criteria:
Inclusion Criteria:

* Adult pregnant woman
* Woman with current diagnosed Eating Disorders or without Eating Disorders
* Having a good command of the French language
* Having given their consent for their participation in the research

Exclusion Criteria:

* Underage pregnant woman
* Woman who does not have a good command of the French language.
* Woman with past Eating Disorders
Vitamin D Supplementation and PTH Response Among Malaysian Adults

This clinical trial was designed to determine the efficacy of vitamin D supplementation on plasma 25-hydroxyvitamin D \[25(OH)D\] and intact parathyroid hormone (PTH) concentrations of Malaysian female adults of child-bearing age after daily intake of vitamin D supplements containing either 0 IU, 600 IU, 1200 IU or 4000 IU vitamin D for 16 weeks.

After being informed regarding the study protocol and requirements, participants given informed consent were interviewed using a questionnaire for collection of background data and medical history as a screening process. Eligible participants were randomly assigned in a double-blind manner to receive daily 500 mg of calcium with either 0, 600 IU, 1200 IU or 4000 IU vitamin D supplement for 16 weeks. Questionnaires and anthropometric measurements were collected at baseline and post 16 weeks supplementation trial. Primary outcomes of plasma 25(OH)D and intact PTH were measured via fasting intravenous blood samples at baseline and post 16 weeks trial.

Eligibility Criteria:
Inclusion Criteria:

* three major ethnic groups (Malay, Chinese, Indian)
* age 20-45 years

Exclusion Criteria:

* any diseases or conditions that may affect vitamin D metabolism, such as diabetes, cardiovascular diseases, bone diseases, autoimmune diseases, had major gastrointestinal surgery and diagnosed primary hyperparathyroidism
* medications that might affect vitamin D metabolism, such as insulin, thiazide diuretics, prednisolone, biphosphonates, tamoxifen and phenytoin
* pregnant and lactating women
The Study of Relationship of Plasma Concentrations of Folic Acid, Vitamin B and Homocysteine With Carotid Atherosclerosis and Endothelium-Dependent Vasodilatation of Geriatric and Young Patients in the Ambulatory Care Department of NTUH

Elevation of plasma homocysteine has been recognized as one of the risk factors of atherosclerotic disease. The objectives of this study are: (1) to investigate the level of plasma homocysteine and the prevalence of hypehomocysteinemia (2) to find out the role of homocysteine in coronary artery disease and the proper cut-off point of plasma homocysteine to evaluate the presence of coronary artery disease; (3) to understand the control condition of tranditional risk factors of cardiovascular disease, especially hypertension, dyslipidemia, and diabetes mellitus.

The study subjects were recruited from the ambulatory setting of cardiology in National Taiwan University Hospital.


Eligibility Criteria:
Inclusion Criteria:

Patient \> 65 y/o or \< 50y/o Scr\<=1.5mg/dL

Exclusion Criteria:

* Scr\> 1.5mg/dl pregnancy alcohoism
A Randomized Controlled Trial on Smoking Cessation and Adherence Intervention on Patients With Erectile Dysfunction

The purpose of this proposed RCT is to test (a) the effectiveness of smoking cessation intervention (counseling and NRT) among patients with ED; and (b) the effectiveness of adherence intervention (ADIN) to increase adherence to NRT use in order to increase quit rate.


Eligibility Criteria:
Inclusion Criteria:

* Male ethnic Chinese aged 18 or above
* Smokes at least 1 cigarette per day
* Is not following other forms of smoking cessation interventions
* Intends to quit smoking within the next 7 days of the first contact and would use NRT
* Free from illness that contraindicate to the use of NRT
* Has signed an informed consent form, or has given verbal consent (for those contacted by telephone)

Exclusion Criteria:

* Patients who are psychologically or physically unable to communicate
* Children and teenagers (aged below 18)
* Those on regular psychotropic medications and in the presence of any serious health problems that may make them unsuitable for using NRT, such as recent stroke, palpitation, or other life threatening conditions
Aneuploidy Rate and Stimulation Protocol: Recombinant Follicle Stimulating Hormone (FSH) Versus Human FSH

Several stimulation protocols have been used in in vitro fertilization (IVF) in a cycle of egg donation; recombinant FSH and human FSH are included. The effect of each kind of hormone on aneuploidy rate it is unknown. If there was an increase on aneuploidy rate of one of these stimulation protocols, there will be a negative effect on the successful rates in the egg donation cycles. The aim of this study is to observe if there is a different in aneuploidy rate and morphological oocyte parameters between different stimulation protocols.


Eligibility Criteria:
Inclusion Criteria:

* Egg donation cycles with more than 8MII in oocyte retrieval day

Exclusion Criteria:

* Male factor
* Uterine malformations
* genetic alterations
A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis

This multi-center observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the licensed label will be followed for 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
* Patient in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in accordance with the local label (DMARD-IR, TNF-IR or need of RoActemra/Actemra monotherapy); this can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit

Exclusion Criteria:

* Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
* Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
* Patients who have received treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
* Patients with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
Optimizing Mindfulness and Acceptance Based Behavioral Treatment for Bulimia Nervosa and Binge Eating Disorder

The current study will use a full factorial design to identify the independent and combined effects of four core MABT components when combined with standard behavioral treatment for BN and BED. The primary aim of the study will be to evaluate the independent efficacy of Mindful Awareness, Distress Tolerance, Emotion Modulation, and Values-Based Decision Making on eating pathology (at posttreatment and at 6 and 12-month follow-ups). Secondary aims will be (1) to test target engagement of each MABT component, i.e., to confirm that each treatment component impacts both the variable which it targets and self-regulation and that improvements in these are associated with improvements in outcomes and (2) to test the hypotheses that the efficacy of each component is moderated by related baseline deficits in self-regulation (e.g. individuals with worse distress tolerance at baseline are most likely to benefit from conditions that include the Distress Tolerance component). A final exploratory aim will be to quantify the component interaction effects, which may be partially additive (because components overlap and/or there is diminishing return), fully additive, or synergistic (in that components may partially depend on each other).


Eligibility Criteria:
Inclusion Criteria:

1. Have experienced 12 or more loss of control episodes within the previous 3 months
2. Have a BMI above 16
3. Are located in the US and wiling/able to participate in remote treatment and assessments
4. Are able to give consent

Exclusion Criteria:

1. Are unable to fluently speak, write and read English
2. Have a BMI below 16
3. Are receiving treatment for an eating disorder
4. Require immediate treatment for medical complications as a result of eating disorder symptoms
5. Have a mental handicap, or are experiencing other severe psychopathology that would limit the participants' ability to comply with the demands of the current study (e.g. severe depression with suicidal intent, active psychotic disorder)
Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators

The purpose of this study is to compare a new noninvasive ventilator to existing ventilators already used for patient care.

This study compares the Respironics California V60 Mask ventilator to conventional noninvasive ventilators in a cross-over study with the patient as his/her own control.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 7 years and \< 18 years
* Weight \> 20 kg (44 lbs)
* Respiratory failure or respiratory insufficiency
* Ability to cooperate with the investigators
* Designated adult able to provide Informed Consent

Exclusion Criteria:

* An endotracheal tube or tracheostomy in place
* Hemodynamically instability
* Prolonged apnea
* Inability to maintain the airway
* A recent history of cardiac and or respiratory arrest
* Acute hemorrhage
* Multiple organ system failure
* Undrained pneumothorax
* High risk for aspiration
* Metastatic or terminal cancer
* Do-not-resuscitate orders
* Inability to clear respiratory secretions
* Inability to fit a mask
* Facial surgery, trauma, or deformity
* Upper gastrointestinal or airway surgery
* Pregnancy
* Refractory delirium
* PaO2 \< 50 mmHg on present settings
* Designee unable or unwilling to provide Informed Consent
Diagnostic and Prognostic Biomarkers of Transplant Dysfunction in the Context of Lung Transplantation

Transplant results vary considerably from one organ to another. Lung transplantation has poorer long-term outcomes than other solid organ transplants, with a current median post-transplant survival of 6.0 years. Allograft rejection remains the leading cause of morbidity and mortality in all organ groups and is the leading cause of death, accounting for more than 40% of deaths beyond the first year after lung transplantation.

Each dysfunctions impacts the fate of the graft and therefore the survival of the recipient. Their early and precise diagnosis is therefore a major issue. The identification of the pathophysiological mechanisms underlying these different subtypes of dysfunction (transcriptomics, polymorphism of target genes of the immune system or tissue repair, cell phenotyping) is an essential step. It can only be done on the basis of a collection of samples linked to a clinical database allowing to contextualize each sample.


Eligibility Criteria:
Inclusion Criteria:

* Men or women over 15 years of age
* Suffering from a lung condition requiring a transplant planned at Foch Hospital or being followed up at Foch Hospital following a lung transplant
* Have signed the informed consent form and for patients aged 15 to 18 years that the person(s) exercising parental authority has/have signed the informed consent.
* Be affiliated with a Health Insurance plan.

Exclusion Criteria:

* Pregnant, parturient and/or lactating woman
* Hemoglobin level less than or equal to 8g/dl
* Persons of full age who are subject to a legal protection measure or who are unable to express their consent
* Persons under the protection of justice
* Not being able to follow the study requirements for geographical, social or psychological reasons
* Patient refusal.
Developing an mHealth Application to Improve Cancer Chemotherapy Symptom Management

This research project addresses critical gaps in cancer symptom management through the creation of a mobile chemotherapy symptom management application. This application will assess for the presence and severity of common chemotherapy side-effects and provide personally tailored symptom-related video and narratives to enhance self-management of cancer and treatment-related symptoms. This study will examine patient acceptance and use of this mHealth application (called MyChemoCare) in a prospective trial of cancer patients (n=60) who are receiving chemotherapy for colorectal cancer at the University of Michigan Comprehensive Cancer Center.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with colon or rectal cancer
* Expected to live at least 6 months
* Initiating chemotherapy for the first time in their treatment history
* Physically and mentally able to participate
* Able to read English
* Willing and able to sign informed consent

Exclusion Criteria:

* A treatment plan that does not include cytotoxic chemotherapy for colon or rectal cancer
* A medical history that includes cancer with the exception of in situ cancers of the cervix and basal cell cancers of the skin
* A current diagnosis that includes multiple cancers (this does not exclude metastatic disease)
* Received prior cytotoxic chemotherapy for any reason
* A diagnosed psychiatric disorder