cyrilzakka/clinical-trials huggingface dataset:
Vitamin D Increases Serum Levels of the Soluble Receptor for Advanced Glycation End Products in Women With PCOS

The purpose of this study is to investigate the mechanism that explain the beneficial clinical effect of vitamin D treatment in women with PCOS.

Seventy-nine women with (n=22) or without (control; n=57) PCOS who were diagnosed with vitamin D deficiency were enrolled. Sixty-three women were treated with oral vit D3 for 8 weeks (16 with PCOS and 47 controls) and 16 women were not treated (6 with PCOS and 10 controls). Serum 25 hydroxy-vitamin D (25 OH-D), sRAGE, and AMH concentrations were measured at baseline and after vit D3 supplementation in the treated group, and 8 weeks apart in the non-treated group. Paired t-test, Wilcoxon signed-rank test, and Pearson correlation were used as appropriate.

Main outcome measure: Changes in AMH concentrations following vit D3 replacement.

Eligibility Criteria:
Inclusion Criteria:

* Vitamin D deficient premenopausal women

Exclusion Criteria:

* Pregnant women
* Women during their postpartum period
* Breastfeeding women
* Women taking any kind of exogenous hormones
* Women receiving any form of oral vitamin D replacement
Impact of Medication Reconciliation at Discharge on Potentially Inappropriate Medications in the Elderly : Community-hospital Coordination

The geriatric population is exposed to poly-medication. Furthermore, old people have important pharmacodynamic and pharmacokinetic changes that expose to much drug iatrogenic. Adverse drug effects are a great cause for hospitalization that is why the knowledge of the complete list of medications taken by the patient is necessary. The poly-medication in elderly can lead to extremely serious clinical consequences and significant costs. Reference documents specific to geriatrics guide the doctor in therapeutic choices. On the one hand, the Laroche's criteria lists all PIM of the French pharmacopoeia in elderly. On the other hand, STOPP/START criteria are a tool for detect PIM listing inappropriate drugs and criteria of potentially drug omissions. This has been validated in French language. It is important that any changes proposed by the geriatrician resulting in just prescription is sustainable beyond the hospitalization to prevent the recurrence of adverse effects. Effective community-hospital coordination is essential.

Medication reconciliation is defined as the formal process of checking the complete, accurate list of a patient's previous medication - including drug name, dosage, frequency, and route - and comparing it with the prescription after a transition of care (on admission, after transfer to another medical unit, and/or at discharge).

Two groups of patients will be created, one for which medication reconciliation at discharge will be practiced and the other a similar process but not standardized. Four to eight weeks after the discharge, the member of the pharmacy team is calling the usual community pharmacy to get the first non-hospital prescription by fax and compare the number of PIM with the prescription before hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age ≥ 75 years
* Pharmaceutical interview at the medication reconciliation at admission in Geriatrics Acute Care Unit.
* ≥ one PIM on the prescription before admission
* Identification of the usual referent community pharmacist
* Output of the unit by a return home
* Affiliation to a social security scheme

Exclusion Criteria:

* Patients undergoing a regime of legal protection.
* Patients unable to cooperate in pharmaceutical interview at the medication reconciliation at admission whatever reason.
* Refusal to participate in the study.
* Output of the unit by transfering to another care unit or death
Responses to COVID-19 Vaccination in Patients With Cancer

This is an observational study that will prospectively record and monitor responses and clinical outcomes of patients with cancer after covid-19 vaccination, including measurements of antibody titers in serum and also record potential factors that affect immunity, such as type and stage of cancer, type and time of systemic therapy in relation to covid-19 vaccination.

It is well recognised that patients with cancer are at an increased risk of severe COVID-19 disease and should be at high prioritisation for vaccination against SARS-CoV-2. In Greece the vaccination of healthcare workers has been initiated in January 2021, elderly citizens as well and for cancer patients of all ages will be initiated early February 2021. There are very little available data on the efficacy of immunisation with vaccines overall in cancer patients, with most existing data involving the influenza vaccine. The covid-19 vaccine trials have not included cancer patients, therefore, the efficacy and duration of immunity in patients with cancer are still unknown. Those patients are often immunocompromised due to their disease or the side-effects of their treatment.

Based on the above this study was designed to prospectively record and monitor patients with cancer after covid-19 vaccination. The study will record and measure clinical outcomes, such as possible infection from covid-19 despite vaccination, severity and mortality, but also possible side effects post vaccination. Within the study serological responses (IgG antibody titers) will also be monitored in three timepoints (prior to vaccination, one month and three months after completion of the two doses of vaccination). Potential factors that affect immunity, will be recorded, such as type and stage of cancer, type and time of systemic therapy in relation to covid-19 vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Patients with solid tumours and potentially immunocompromised, ie. currently with active disease and/or undergoing active antineoplastic therapy of any type (chemotherapy, immunotherapy, biologic therapy, targeted therapy) that will be vaccinated for covid-19 within the National Program of Vaccination
* patients must sign informed consent for their data monitoring and also for serum antibody titers to covid-19 vaccination measured in three timepoints, prior to 1st dose and 1 and 3 months post completion of two doses

Exclusion Criteria:

* patients with haematological malignancies are excluded
* patients with prior diagnosis of cancer and now on follow-up without active disease are excluded
* patients on adjuvant hormonal therapy are excluded
Genetic Influence on Susceptibility to Type 1 Diabetes Mellitus

Type 1 diabetes mellitus is an autoimmune disease in which the body's immune cells attack the insulin-producing cells of the pancreas. Several environmental and genetic factors may predispose individuals to developing this disease, including changes in a gene called CD152. This study will examine how this gene may influence the development of insulin-dependent diabetes.

Patients with Type 1 diabetes mellitus enrolled in clinical trials at the National Institutes of Health and at the University of Florida and healthy normal volunteers may participate in this study. Participants will have up to three blood samples drawn over a period of less than 1 year. The first sample (about 20 milliliters, or 4 teaspoons), will be examined for changes in the structure of the CD152 gene. If the CD152 structure is different from that normally seen in the general population, a second sample (about 90 ml, or 6 tablespoons of blood) will be drawn. This sample will be used to study the function of specialized immune system cells (T cells), including their growth and survival, chemicals they produce when stimulated, and other factors. If these cells function differently from what is generally seen in the population, a third sample (90 ml) will be drawn for more detailed studies.

This investigation may help explain what makes certain individuals susceptible to Type 1 diabetes mellitus and may contribute to the development of improved treatments for the disease.

Genetic variations in CD152 have been reported to confer susceptibility to the development of type-1-diabetes mellitus (T1DM). In this protocol we will draw blood samples from patients and normal control volunteers in order to analyze for the presence of CD152 genetic variations and to determine whether those variations are associated with measurable abnormalities in T cell function. Subjects with T1DM and homozygous CD152 gene polymorphisms, patients with T1DM but without CD152 polymorphisms, and control subjects with or without CD152 polymorphisms will be studied to determine whether the CD152 polymorphisms have measurable effects on T cell function and signaling. We will assess T cell function by measuring: proliferation, viability, apoptosis, cytokine production and T cell signal transduction. The identification and characterization of genes that are linked to T1DM may provide an explanation into the mechanisms by which individuals are predisposed to T1DM.

Eligibility Criteria:
Patients must have a willingness and legal ability to give consent, or permission.

Candidates with T1DM or Healthy Volunteers will be eligible.

Patients must be equal to or greater than 18 years of age.

Patients must not have an active malignancy.

Patients with a hemoglobin count of less than 9.0 mg/dl will be excluded. Patients may be on erythropoietin therapy, but will not be placed on therapy solely to facilitate research sample acquisition.

Patients must not have a known immunodeficiency syndrome.
Efficacy and Safety of rhGH (Jintropin®) in Pediatric Participants With ISS

Phase 1: To evaluate the safety and efficacy of 0.05mg/kg/d of rhGH (Jintropin®) in the treatment of children with idiopathic short stature (ISS) in 52 weeks.

Phase 2: To evaluate the safety and efficacy of rhGH (Jintropin®) in the treatment of children with ISS in 2 years


Eligibility Criteria:
Inclusion Criteria:

* Boys are between 4 and 10 years old age and girls are between 4 and 9 years old age;
* Height \<-2.25 SD (Standard deviation) for chronological age;
* GH (Growth hormone) peak concentration ≥10.0 ng/mL in GH stimulation tests;
* The bone age (BA) ≤chronological age (CA)+6 months;
* Prepubertal Status (Tanner Stage I);
* Birth weight within the normal range;
* Growth hormone treatment-naive;
* Participants are willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, to sign informed consent.

Exclusion Criteria:

* Participants with abnormal liver and kidney functions (ALT \> upper limit 1.5 times of normal value; Cr \> upper limit of normal value);
* Participants are positive for anti-HBc, HbsAg or HbeAg in Hepatitis B virus tests;
* Participants with known highly allergic constitution or allergy to investigational product or its excipient;
* Participants with systemic chronic disease and immune deficiency;
* Participants diagnosed with tumor, or with potential high tumor risks such as tumor markers exceed normal range and some other relative information may be excluded from the treatment;
* Participants with mental disease;
* Participants with other types of abnormal growth and development;

  1. Growth hormone deficiency (GHD) (confirmed by GH stimulation test);
  2. Turner syndrome (confirmed by karyotype test of girls);
  3. Noonan syndrome (hypertelorism, pectus carinatum, hypophrenia, frequently with skin disease and congenital heart disease, missense mutation of the protein tyrosine phosphatase, non-receptor type 11 (PTPN11) gene on chromosome 12 for half of the participants, for both male and female participants);
  4. Laron syndrome (confirmed by IGF-1 generation test);
  5. Small for gestational age ( the birth height or weight is below the tenth percentile or 2 SD, with catch-up growth uncompleted at 2 years old);
  6. Growth disorders caused by malnutrition or hypothyroidism (thyroid function test).
* Participants with impaired glucose regulation (IGR) (including impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) ) or diabetes;
* BMI (Body mass index) ≥22kg/m²;
* Congenital skeletal abnormalities or scoliosis, claudication;
* Participants who took part in other clinical trials within 3 months;
* Participants who received medications which may interfere GH secretion or GH function, or other hormones within 3 months (such as sex steroids, glucocorticoids, etc.);
* Other conditions which is inappropriate for this study in the opinion of the investigator.
CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients

This is a phase 3, randomized, placebo controlled, double-blind, multicenter, stratified study of CPI-006 plus standard of care (SOC) versus placebo plus SOC in mild to moderately symptomatic hospitalized Covid-19 patients with the primary objective to compare the proportion of participants alive and respiratory failure free between CPI-006 plus SOC versus placebo plus SOC.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed positive by polymerase chain reaction (PCR) or antigen test for SARS-CoV-2 with sample collection ≤ 10 days prior to randomization
* Covid-19 illness of any duration of symptoms
* Hospitalized for Covid-19 for ≤ 5 days with mild to moderate Covid-19 symptoms and meets criteria for either Category 4, Category 5, or Category 6 per 8-point ordinal scale
* Adequate organ function
* Participants of child-bearing age must agree to use adequate contraception for 6 weeks after study treatment administration

Exclusion Criteria:

* Signs of acute respiratory distress syndrome or respiratory failure necessitating mechanical ventilation at time of screening/randomization or anticipated need for mechanical ventilation
* History of severe chronic respiratory disease and requirement for long-term oxygen therapy
* Uncontrolled active systemic infection or hemodynamic instability requiring admission to an intensive care unit
* Malignant tumor receiving treatment, or other serious systemic diseases affecting life expectancy within 29 days of screening
* Receipt of cancer chemotherapy or immunomodulatory drugs during preceding 2 months (steroids for treatment of Covid-19 are acceptable)
* Convalescent plasma (CCP) or anti-SARS-CoV-2 monoclonal antibodies administered \<24 hours prior to randomization. Must have recovered from any adverse events related to CCP treatment. Received chloroquine or hydroxychloroquine within last 7 days or during the study
* Current participation in other clinical trials including extended access programs
* Active deep vein thrombosis or pulmonary embolism within last 6 months
* Anticipated discharge from hospital or transfer to another hospital which is not a study site within 48 hours of admission
* Active uncontrolled co-morbid disease that may interfere with study conduct or interpretation of findings
* Known to be positive for HIV or positive test for chronic HBV infection or positive test for hepatitis C antibody
* Pregnancy or breast feeding
Evaluation of Somatostatin Receptor Expression in PET 68Ga-DOTATOC in Patients Followed for Metastatic Breast Cancer

DOTABREAST: Evaluation of Somatostatin Receptor Expression in PET 68Ga-DOTATOC in Patients Followed for Metastatic Breast Cancer

This is a prospective, monocentric, non-controlled, non-randomized, open-label, interventional study.

In women, breast cancer is the 1st largest cancer and accounted for 31% of new cancer cases in women in 2017. With 11,913 deaths in 2015, breast cancer is the 1st largest cancer death in women (19%) and the 3rd largest cancer death (men and women included) after lung and colorectal cancer. At initial diagnosis at any stage, approximately 31% of patients have regional lymph node involvement and 5 to 10% present metastatic involvement from the outset. Progression to a metastatic form occurs in about 20% of cases. The risk of metastatic evolution is variable depending on the histological subtype and is a major prognostic event directly impacting overall survival. DOTATOC-68Ga PET scans allows in vivo evaluation of SST2 somatostatin receptor expression. Its use is widely validated in clinical practice for the assessment of extension of neuroendocrine tumors. It is also being used to evaluate the feasibility of SST2-targeted internal radiotherapy therapy with Lutathera (177Lu-Oxodotreotide) in patients with metastatic small intestine neuroendocrine tumours.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Patients with metastatic breast cancer who have completed at least one first line of systemic therapy for metastatic breast cancer
* Patient labeled on the primary lesion ER+HER2- (20)
* Presence of metastatic liver and bone lesions identifiable with 18F-FDG PET-Scan
* Presence of at least 10 identifiable secondary lesions in 18F-FDG PET-Scan
* No therapeutic change between 18F-FDG PET-Scan and 68Ga-DOTATOC PET-Scan.
* Performing the PET scan with 68Ga-DOTATOC within a maximum of 21 days after the 18F-FDG PET-Scan
* Person affiliated to or benefiting from social security
* Person who has given written informed consent

Exclusion Criteria:

* Patients followed or with history of other active neoplastic pathology (including neuroendocrine tumor)
* Known allergy to 68Ga-DOTATOC or its excipients
* Subject refusing to sign the consent to participate
* Minor subject
* Subject excluded from another study
* Persons referred to Articles L1121-5 to L1121-8 of the Public Health Code (CSP)
* Subject cannot be contacted in case of emergency
Effects of Transcranial Magnetic Stimulation in Incomplete Spinal Cord Injury

The main objective is to conduct a study protocol to investigate the effects of repetitive Transcranial Magnetic Stimulation (rTMS) on sensory and motor performance of individuals with incomplete spinal cord injury (iSCI) . A double-blind randomized sham-controlled trial of patients with iSCI will be conducted.

Effective rehabilitation programs for individuals with incomplete spinal cord injury (iSCI) are required either in the acute or in the post-acute care. Rehabilitation techniques based on protocols that selectively stimulate specific pathways along the central nervous system have been considered effective in enhancing neurologic recovery thereby improving functional abilities. The rationale relies on the assumption that the stimulation of the corticospinal tract, primary motor cortex, and spinal cord might induce neuronal reorganization of structures that are largely involved in the control of voluntary movements. In this line of reasoning, protocols involving repetitive transcranial magnetic stimulation (rTMS) have been found effective in enhancing corticospinal synaptic transmission, attenuating neuropathic pain, improving spasticity and sensorimotor function after iSCI. However, controversial findings have also been reported, as other studies showed unaltered central pain, as well as cortical excitability and sensorimotor function. The lack of consistent results is probably associated with differences in stimulation parameters, number of sessions, site of stimulation, chronicity and levels of injury, and outcome measurements of the previous studies. Thus, it is clear that there are remaining gaps in our knowledge and the development of new studies, preferably prospective fully double-blind placebo-controlled trials, is necessary to complement the current knowledge about the effects of rTMS in patients with iSCI.

Eligibility Criteria:
Inclusion Criteria:

* Have a clinical diagnosis of iSCI with nonprogressive etiology
* Clinical stability
* Aged between 18-60 years old
* Score equal to 24 in the Mini-Mental State Examination
* No electroencephalography alterations
* Absence of depression assessed by Hamilton Depression Scale
* Currently receiving inpatient rehabilitation in Physiotherapy Health Center of University of the State of Paraiba, Brazil.

Exclusion Criteria:

* Have metal prosthesis in some part of the body
* Use cardiac pacemaker
* Present dementia or neurological disorders which can increase cortical excitability
* Have psychotic or schizophrenic disorders
* Take drugs that reduce seizure threshold or spasticity.
Safety and Effectiveness of CARE1.02 Spectacle Lens in Myopia Control

China is a major country in myopia, with the highest number of teenagers suffering from myopia. Controlling the progression of myopia and the related complications caused by axial elongation have clinical significance and social value. Currently. There is a lack of researches on the impact of specially designed myopia control spectacle lens in adolescents aged 12 and above. Therefore, The researchers plan to conduct a randomized controlled trial among myopia adolescents aged 12-17 in middle and high schools in Guangzhou, to test and verify the safety and effectiveness of CARE1.02 on myopia control compared with single-vision spectacle lens.


Eligibility Criteria:
Inclusion Criteria:

* Aged 12 to 17 years;
* Under the condition of bilateral cycloplegic autorefraction, the spherical refractive error of -0.50 to -8.00 D in each eye and astigmatism of not more than 1.50 D and anisometropia of not more than 1.50 D;
* Best-corrected visual acuity of equal or better than 0.00 LogMAR (\>= 1.0 as Snellen).
* The intraocular pressure of 10 to 21mmHg.
* Volunteer to participate in this clinical trial with signature of the informed consent form.

Exclusion Criteria:

* History of eye injury or intraocular surgery;
* Clinically abnormal slit-lamp findings;
* Abnormal fundus examination;
* Ocular disease, such as uveitis and other inflammatory diseases,glaucoma, cataract, fundus diseases, eye tumors, dominant strabismus, and any eye diseases that affect visual function;
* Systemic diseases causing low immunity (such as diabetes, Down's syndrome, rheumatoid arthritis, psychotic patients or other diseases that researchers think are not suitable for wearing glasses);
* Participation of the drug clinical trial within three month and the device clinical trial within one month;
* Only one eye meets the inclusion criteria;
* Unable to have regular follow-up;
* Participation of any myopia control clinical research trial within three months, and currently using rigid contact lenses (including nursing products), multifocal contact lenses, progressive multifocal lenses and other specially designed myopia control lenses, atropine drugs, etc.