cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Effect of Coronavac Vaccine (Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 Vaccine) on Healthcare Workers' Menstrual Patterns

Coronavac, one of the vaccines developed within the scope of combating the COVID-19 pandemic that has surrounded the world for a year, started to be applied in the first healthcare workers in our country. In this important step taken to end the pandemic, information on vaccines is still limited. Most vaccines, including the Coronavac vaccine, are applied with approval for emergency use before phase 3 studies are fully completed. While investigating the effect of the vaccine on the virus, possible side effects should also be considered. In this context, it is not known whether the vaccine has an effect on the menstrual cycle, especially of women of reproductive age.

Our primary aim in our study is to evaluate the effect of the vaccine on the menstrual cycle and if the vaccine has any effect on the menstrual cycle, what kind of changes this effect causes.

The survey contains 20 questions aimed at obtaining information about the menstrual cycles of health workers before and after vaccination. Demographic data of the participants are also taken.

Eligibility Criteria:
Inclusion Criteria:

* be positive for covid-19 (severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 )
* Having 1 or 2 doses of vaccine
* have menstruation
* Being a female health worker
* not using drugs that can affect menstruation

Exclusion Criteria:

* be negative for covid-19(severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 )
* have no menstruation
* Being a male health worker
Effect of Rice Fortification With Iron on Anemia Among Children

This was a double-blind community-based trial, placebo controlled. During 16 weeks, children in the intervention group (GI, n=180) received iron fortified rice, and children in the control group (GC, n=174) received rice with placebo. Anemia was considered present when hemoglobin \< 11.0g/dL. Comparison of mean variation on hemoglobin between groups was accessed by using Student's t-test. Hemoglobin concentration improved in both groups, with mean increase of 0.42 g/dL in GI (11.28±1.23 g/dL to 11.75±1.16 g/dL, p \< 0.001), and 0.49 g/dL in GC (11.06±1.13 g/dL to 11.51±1.16 g/dL, p \< 0.001). Anemia decreased (p \< 0.01) in both groups (37.8% to 23.3% in GI and 45.4% to 33.3% in GC), with no differences between them. Hemoglobin increase was significantly higher in children who received total amount of iron ≥ 53.76 mg from fortified rice, compared to those who received less than this cut-off value (0.94 g/dl vs 0.39 g/dl p=0.03). The results suggest that this type of intervention can be useful in anemia control if fortified food intake is adequate.


Eligibility Criteria:
Inclusion Criteria:

* pre-school children attending public day care centers

Exclusion Criteria:

* sickle cell anemia, purpura
R.CULT.HEA - URban Environment, CULTural Social Use of Space and HEAlth / Well-being Effect on Population

This cluster randomized trial will test the affect of individual participation in culturally- and socially-related activities on health and well-being, in comparison also with the classic individual determinant, in relation to urban renovation schemes. Investigators will using a questionnaire based on several areas such as individual psychological well-being (PGWBI), individual happiness positioning (Keyes Scale) and health status perception (SF-12 Health Survey). Secondary outcomes will be related to social capital density (relationships and trust), culture (participation) and religion. The survey will be undertaken in a mid-size Italian metropolitan area, namely the Metropolitan City of Bologna.


Eligibility Criteria:
Inclusion Criteria:

* Gender: men and women;
* Age range between 18 and 75 years old;
* Residency: in an area of 2 square kilometers surrounding the Casa del Popolo

Exclusion Criteria:

* participants no having the previous features
Assessment of a New Surgical Smoke Clearing Technology in Laparoscopic Cholecystectomy

The study will examine the safety and performance of a new surgical smoke clearance system designed for use during laparoscopic surgery.

The study will examine the safety and performance of a new surgical smoke clearance system which has been developed to maintain a visually clear operative field during laparoscopic surgery by using electrostatic precipitation to clear, from the surgical field, smoke and plume produced by energy based surgical instruments e.g. electrocautery, laser tissue ablation and ultrasonic scalpel tissue dissection.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, at least 18 years of age
2. Undergoing elective laparoscopic cholecystectomy for documented symptomatic gallstone disease
3. Patient or authorised representative must be able to comprehend and sign the Informed Consent Form prior to enrolment in the study.

Exclusion Criteria:

1. \<18 years of age
2. Pregnant or lactating females
3. Previous extensive abdominal surgery, which in the opinion of the Investigator presents a \>5% risk of conversion to an open procedure being required
4. Current participation in another device or drug study
5. Unwilling or unable to provide informed consent
Transdermal Insulin Response In Healthy Volunteers

Bio-fermentation produced Human insulin is available without prescription in the U.S. This study is a physician-initiated trial of a formula enabling transdermal delivery of human insulin.

The primary objective of the study is to determine the amount of lowering serum glucose as a function of dose of a topically applied formulation of Human Insulin administered by syringe measurement to adult Healthy Volunteer subjects as compared to no treatment. A 5-day period of daily blood sugar monitoring by means of wearable Continuous Glucose Monitor and insulin dosing for 3 days then monitoring for at least 3 days following will form the baseline and experimental data for each subject.

The secondary objective is to evaluate the tolerability and local and systemic effects of transdermal Human Insulin if any.

Eligibility Criteria:
Inclusion Criteria:

1. The subject has a serum protein HbA1c of less than 6.
2. The subject is willing and able to read, understand the Subject Information Sheet and provide written informed consent.
3. The subject has a body mass index (BMI) within 18-50 kg/m2.
4. The subject is in otherwise good health as determined by medical history and physical examination.
5. The subject is a non-smoker.
6. The subject must agree to continue with daily serum glucose testing by means of a wearable blood glucose for the pharmacokinetic assessments.
7. The subject is willing and able to comply with all testing and requirements defined in the protocol.
8. The subject is willing and able to return to the study site for all visits.

Exclusion Criteria:

1. The subject has any relevant deviations from normal other than blood glucose in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator.
2. The subject has had a clinically significant illness within 30 days preceding entry into this study.
3. The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.
4. The subject has a known allergy or history of hypersensitivity to Human Insulin or similar modified Insulin compounds.
5. The subject has used any prescription medication that may interfere with the evaluation of study medication.
6. The subject has donated or lost a significant volume of blood (\>450 mL) within four (4) weeks of the study, and their Haemoglobin concentration and haematocrit have not returned to within 5% of normal.
7. The subject has a history of substance abuse or a current positive urine drug screen or urine alcohol test.
8. Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males).
9. Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry
End-Expiratory Lung Volume in Children Awakening From Propofol Anesthesia

The goal of this pilot randomized clinical trial is to test the effects of high flow nasal oxygen and head elevation during awakening from propofol anesthesia in pediatric patients undergoing airway surgery.

The main question\[s\] it aims to answer are:

* High flow oxygen can decrease the occurence of atelectasis during awakening from propofol anesthesia in pediatric patients?
* Head elevation can decrease the occurence of atelectasis during awakening from propofol anesthesia in pediatric patients?

Researchers will compare high flow oxygen vs low flow oxygen group to see if the use of high flow oxygen decrease the occurence of atelectasis during awakening from propofol anesthesia.

And in each group, the patients will be assigned to supine position vs head elevation position to compare the effects of head elevation during awakening from propofol anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients undergoing airway surgery with high flow nasal oxygen

Exclusion Criteria:

* Loss of spontaneous ventilation during surgery
* less than 1 months
* cyanotic patients
Safety and Pharmacokinetics Study of XOMA 052 in Subjects With Active, Stable, Moderate to Severe Rheumatoid Arthritis

Study X052070 will evaluate the safety and pharmacokinetics (PK) of XOMA 052 administered to patients with active, stable, moderate to severe rheumatoid arthritis (RA).

It is hypothesized that administration of XOMA 052 is likely to improve inflammatory control in subjects with RA.


Eligibility Criteria:
Inclusion Criteria:

* American College of Rheumatology (ACR) diagnostic criteria for RA
* Moderate to severe disease, defined as follows - At least six tender and six swollen joints (28 joint count) AND ESR \> 28 mm/hr or CRP \> 1.0 mg/dL
* Current duration of RA at Screening ≥ 6 months and ≤ 20 years
* RA and other medical conditions must be stable.
* Age ≥ 18 and ≤ 75 at Screening
* Weight ≥ 80 lbs (36.3 kg) and ≤ 275 lbs (125.0 kg)
* For females with child-bearing potential, a negative serum pregnancy test

Exclusion Criteria:

* Major surgery within 28 days prior to Day 0
* Joint replacement surgery within 60 days prior to Day 0 or joint replacement surgery planned within 9 months following Day 0
* Known HIV antibody, or hepatitis B surface antigen
* History of malignancy within 5 years prior to Screening other than carcinoma in situ of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin
* Immunodeficiency
* History or symptoms of a demyelinating disease
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. Respiratory distress (dyspnea, oxygen desaturation with pO2 \< 90% or onset of acute respiratory distress syndrome), flank or back pain, and/or hypotension may be signs of anaphylaxis.
* History of tuberculosis, positive PPD test, active atopic disease requiring medication, or asthma. A subject who has had a positive PPD test but has completed a course of treatment for tuberculosis, had a documented vaccination against tuberculosis, or had a negative QuantiFERON -TB test result is eligible.
* Chronic obstructive pulmonary disease (COPD), asthma, or other pulmonary disease requiring more therapy than using one inhaler 4× daily
* Significant systemic involvement secondary to RA (e.g. vasculitis, pulmonary fibrosis)
* Liver disease (e.g., hepatitis, cirrhosis) or abnormal hepatic function. If the diagnosis of liver disease was based on positive Hep C serology due to prior vaccination, the subject is eligible.
* Pregnant or planning to become pregnant during the course of the study, or breast-feeding
Assessment of Corneal Topography and Densitometry in Rheumatoid Patients

Corneal transparency is a result of its unique ultrastructure with collagen fibrils regularity, integrity of connective tissue, and balanced keratocyte components. Corneal densitometry is known to be altered in cases corneal haze or scar, but recently it is assumed to be altered earlies in presence of a systemic inflammatory disease, even before clinical manifestations take place.

The aim of this study is to assess changes in corneal topography and corneal densitometry in RA patients with clinically clear corneas and to compare these results with those of healthy control subjects.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with rheumatoid arthritis

Exclusion Criteria:

* corneal opacity; severe dry eye; glaucoma; any inflammatory ocular disorder or infection including blepharitis, conjunctivitis, meibomitis and dacryocystitis; central or peripheral thinning evident in slit-lamp examination; history of ocular surgery, trauma, or contact lens use; and patients using any topical medication other than artificial tears will be excluded from the study.
PK and PD Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis

The purpose of this study is to determine if the calcitriol absorption in pediatric subjects is comparable to that in adults and adolescents, with no significant impact on calcium/phosphorus metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Male or female pediatric subjects, 2 to 12 years of age inclusive at screening
* Clinical diagnosis of plaque type psoriasis involving 3% through 35% body surface area at screening and baseline (excluding face and scalp)

Exclusion Criteria:

* Subjects with guttate or pustular psoriasis, erythrodermic psoriasis or active infection
* Vitamin D deficiency at screening
* Subjects with hypercalcemia and out of range urinary calcium/creatinine ratio at screening
* Subjects with secondary hyperparathyroidism at screening
Emotion Awareness and Skills Enhancement Program

This project will address impaired emotion regulation in adolescents with ASD (autism spectrum disorder). There are no evidence-based interventions to improve emotion regulation (ER) in this population, yet poor emotion regulation often leads to maladaptive behavior and substantially impedes capacity to learn and function across all life settings, and reduce their quality of life and that of their families. The primary objective of this study is to formally evaluate efficacy of EASE via a sufficiently powered, two-site randomized-controlled trial (RCT).

The current study is to test a new intervention called Emotional Awareness and Skills Enhancement (EASE). This program was designed to address ASD-specific obstacles to effective emotion regulation, such as reduced awareness concerning others' intentions, a limited repertoire of behavioral responses, and inadequate language for understanding emotional experiences. This new program is based on an acceptance-based approach in which awareness of emotion is developed, emotions (whether negative or positive) are accepted, and behavior is regulated in the face of intense emotion. The goal is not to learn to avoid negative emotions, but rather to develop a collection of abilities which allow the individual to manage stress and act in ways that are more adaptive. The investigators expect to find that participants' emotion dysregulation will decrease and their adaptive function will increase following completion of the EASE program.

Eligibility Criteria:
Inclusion Criteria:

1. ages 12-21 years, inclusive
2. A diagnosis of ASD (autism spectrum disorder), as defined by exceeding the ASD cutoff on the ADOS-2 (Autism Diagnostic Observation Scale) or ADI-R (Autism Diagnostic Interview-Revised) In. If the participant has completed the ADOS in a previous study within 3 years and signs a release of information to obtain it, they will not be required to complete another ADOS.
3. Average verbal intellectual ability (Wechsler Abbreviated Scale of Intelligence-2 \[WASI-2\] FSIQ \>=75).
4. Fluent in the English language
5. Problems with regulating emotions based on parent report 6) Parent/guardian who will attend sessions and assessments.

Exclusion Criteria:

1. Current concerns of suicidality that warrants immediate clinical care (such potential participants will be referred elsewhere for treatment), determined by clinical interview.
2. Previous or current diagnosis of a psychotic disorder.
3. Receiving concurrent psychotherapy treatment for emotional issues (i.e., depression, anxiety, anger) that overlaps with the current study. This will be assessed using current treatment items on the demographic forms.
Efficacy and Safety Study of SUNPG1622

This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the efficacy and safety of SUNPG1622.


Eligibility Criteria:
Inclusion Criteria:

* Subject has provided informed written consent
* Subject is ≥ 18 years of age at time of Screening
* Subject must be on a stable dose of NSAID for ≥ 2 weeks prior to initiation of investigational product
* Subject has a negative test for TB within 4 weeks before initiating IMP

Exclusion Criteria:

* Subjects with known diagnosis of fibromyalgia or complex regional pain syndromes
* Active uveitis or symptomatic inflammatory bowel disease requiring therapy at screening
* Radiographic evidence of total ankylosis of the spine
* Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pre-treatment condition
Evaluation of Efficacy of Cryotherapy for Skin Anesthesia During Arterial Puncture

the purpose of this study is to evaluate the cryotherapy effect by vapocoolant spray to reducing pain during puncture for artérial blood gas

Blood gas analysis by arterial puncture is the Gold Standard in the assessment of a patient's acidbase status and oxygenation. This procedure, which can be repeated depending on the clinical condition of patient, is however associated with a potentially painful experience for patients.

The known anesthetic properties of cold can be an interesting alternative to evaluate in the reduction of pain induced during arterial puncture for gas analysis in critically il patients.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients (age≥18 years) hospitalized in Intensive Care Unit
* Patient requiering arteriale puncture for ABG
* A négative score of CAM ICU scale
* Patient with a score to visual analog scale \< or equal 30mm
* Securité sociale affiliated
* consentement

Exclusion Criteria:

* patient undergoing mechanical ventilation
* patient with arterial catheter
* patient with arterio veinius fistul
* patient receiving topical anesthesic at least 2 h before the puncture
* patient with cutaneous lesion (zone of puncture)
* Raynaud Syndrom
* cold sensibility
* Allen test negative
* pregnant
* legal guardianship
Evaluation of a Microendoscopic Imaging System in Examination of Resected Tissues

The overall objective of this exploratory, laboratory study is to evaluate whether noninvasive fluorescence microendoscopic imaging of tissue can assist clinicians in detecting dysplastic (precancerous) areas during standard surveillance. This is a study designed to evaluate the feasibility of using prototype imaging technology to enhance the detection of precancerous changes in various tissues. The results of this laboratory study will be used to further develop the technology for clinical application.

The primary aim of this project will be to investigate what digital image analysis criteria can be used to best detect dysplasia in various types of resected tissue.


Eligibility Criteria:
Inclusion Criteria:

* Males and females over the age of 18 scheduled for standard of care resection of abnormal tissue

Exclusion Criteria:

* Previous chemotherapy or radiation treatment to the tissue to be resected
* Inability to provide consent
Bisphosphonate Therapy for HIV-Infected Adults With Decreased Bone Mineral Density

Bisphosphonates are a type of drug used to prevent and treat bone loss. The purpose of this study is to determine if zoledronate, an investigational bisphosphonate, can improve bone mineral density (BMD) in HIV-infected adults.

Study hypothesis: Zoledronate will reduce bone resorption in HIV-infected persons with osteopenia.

Decreased BMD and bone loss is estimated to affect up to 67.5% of the HIV-infected population. HIV-associated bone loss may be a result of antiretroviral treatment (ART), but can also be caused by the infection itself. To date, treatment for this bone loss has not been established. Before prescribing drugs to treat bone loss, physicians must take into account patients' already demanding ART schedules and potential nonadherence. This study will evaluate the efficacy of a single IV dose of zoledronate, an investigational bisphosphonate, in treating HIV-associated bone loss.

This study will last 1 year. Participants will be randomly assigned to receive zoledronate or placebo at study entry; their assigned intervention will be given in a 20- to 30-minute infusion on an outpatient basis. There will be 7 study visits: at screening, study entry, Week 2, and Months 3, 6, 9, and 12. Blood collection will occur at all visits. Medical history, a physical exam, a dual-energy x-ray absorptiometry (DEXA) scan to measure bone density, and a nutrition evaluation will occur at selected visits.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected
* On stable antiretroviral regimen for at least 3 months
* Able to walk
* Lumbar spine or total hip BMD T-score at least 1.5 SD and no more than 3.5 SD below the mean BMD
* No prevalent fractures at entry OR 1 prevalent vertebral fracture that has been asymptomatic during the last 2 years prior to study entry
* HIV viral load of less than 5000 copies/ml within the 2 months prior to study entry
* CD4 count of more than 100 cells/mm3 within the 2 months prior to study entry
* Willing to use acceptable forms of contraception during the study period and for 6 months after study completion. Participants who are female and postmenopausal will be required to take hormone replacement therapy during this study.

Exclusion Criteria:

* Prior treatment with bisphosphonates or fluoride
* Use of supraphysiologic systemic estrogen/androgen therapy or corticosteroid therapy within the 3 months prior to study entry. Participants who have taken hormone replacement therapy are not excluded.
* Significant liver or kidney disease
* Hemoglobin less than 8 g/dL
* Serum calcium less than 8 mg/dL
* Laboratory evidence of low levels of estrogens or androgens
* Laboratory evidence of overactive parathyroid glands
* History of thyroid, parathyroid, or other endocrinologic disorder known to affect bone
* Current use of any therapy known to affect bone
* Current or history of cancer or chemotherapy
* Current or history of radiotherapy to the jaw
* Current osteomyelitis of the jaw or ongoing dental infection
* Recent tooth extraction or major dental procedure within 3 weeks of study entry
* Pregnancy or breastfeeding