cyrilzakka/clinical-trials huggingface dataset:
Endoscopy in Anemic Children

Assess the role of Upper and lower gastrointestinal endoscopy in evaluation of refractory iron deficiency anemia in children


Eligibility Criteria:
Inclusion Criteria:

* children with iron deficiency anemia not responding to medical treatment for more than 6 weeks

Exclusion Criteria:

* children with iron deficiency anemia responding to medical treatment Children below 1 years and above 18 years old
The Effect of a Single Spinal Manipulation on Cardiovascular Autonomic Activity

This study evaluates the effect of a single high-velocity low-amplitude spinal manipulation on both cardiovascular autonomic activity and pressure pain thresholds.

It is a cross-over study, thus each participant will undergo both interventions (spinal manipulation and sham manipulation). Both interventions will be separated by a 48 h wash-out period.

Several systematic reviews have shown that spinal manipulations may have an immediate effect on autonomic nervous system activity (e.g. increase in skin sympathetic nerve activity) and on sensitivity to experimentally-induced pain (e.g. increase in pressure pain threshold).

It is generally unknown i) if these supposed effects last after the immediate post intervention period and ii) if there is a statistical relationship between them, considering that pain and autonomic networks are closely connected and interact at the peripheral, spinal and supra-spinal levels.

The primary aim of the study is to assess every single effect immediatly and at short-term after the intervention.

The secondary aim is to assess the bivariate statistical relationship between cardiovascular autonomic activity and sensitivity to experimentally-induced pain after the intervention.

Cardiovascular autonomic nervous system activity is assessed with both heart rate and systolic blood variabilities

Sensitivity to experimentally-induced pain is measured using pressure pain threshold.

Eligibility Criteria:
Inclusion Criteria:

* First-year chiropractic student at IFEC
* Volunteer
* Healthy (no pain, no disease)

Exclusion Criteria:

* Counter indications to spinal manipulation
* Drugs intakes (pain killers or beta-blockers)
* Food, Caffeine and tobacco intakes during the previous hour
* Alcohol intake and performance of strenuous physical activity the day of the experimentation
Serranator Recoil Study

The study objective is to assess the ability to define and measure post treatment recoil in infrapopliteal arteries. Preliminary evidence as to the differences between serration angioplasty and standard balloon angioplasty as defined by post treatment recoil, lumen gain, and dissection will be collected.

Multi-center, feasibility study treating up to 20 atherosclerotic lesions in the infrapopliteal arteries. The study will capture angiographic imaging (pre, during, post, and post 15 mins) for all lesions, and a subset (up to 10) of IVUS imaging data (pre, post, and post 15 mins), to compare serration angioplasty vs standard angioplasty and its effects on vessel recoil and final diameter stenosis.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female of \>18 years old.
2. Women of childbearing potential must have a negative urine pregnancy test within 7 days of index procedure.
3. Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and comply, and has signed the consent form.
4. Subject has Rutherford Clinical Category 3, 4, 5, or 6.

Angiographic Inclusion Criteria:

1. Target lesion(s) has stenosis \>70% by visual assessment;
2. De-novo, or non-stented re-stenotic lesions;
3. Reference vessel diameter is between 2.5 mm and 3.5 mm, inclusive;
4. Target lesions involve infrapopliteal tibial arteries including pedal;
5. A target lesion may consist of one long or multiple serial lesions that are up to and including 12 cm in length;
6. If a second lesion is identified in another vessel, the second lesion can also be treated and if treated will be treated with the alternate treatment.

Exclusion Criteria:

1. Evidence of aneurysm or acute thrombus in the target vessel.
2. Subject has an allergy to contrast medium that cannot be pretreated.
3. Subject is pregnant or breastfeeding.

Angiographic Exclusion Criteria:

1. Acute Total Occlusions; evidence of acute thrombus formation by angiography.
2. In-stent restenotic lesions.
3. Inability to cross the lesion with the assigned study device.
4. Treatment of target lesion with atherectomy.
The Effect of Vitamin D Therapy on Morbidity and Moratlity in Patients With SARS-CoV 2 Infection

The ongoing pandemic of SARS CoV-2 virus is calling for effective preventive and theraputic interventions. Vitamin D has been shown to play immunemodulatory functions in human. Low vitamin D levels have been linked to increased susciptability to infections especially the acute respiratory infections. This randomised controlled study aims to explore the effect of vitamin D administration on the outcome of SARS- CoV2 virus

Background: Coronavirus disease COVID-19 is an ongoing pandemic and is causing avoidable fatalities worldwide. Vitamin D plays an essential role in the immune system. Vitamin D interferes with the majority of the immune systems cells such as macrophages, B and T lymphocytes, neutrophils and dendritic cells. We aim to find whether supplementation of vitamin D deficient diabetes with a single intramuscular cholecalciferol injection could improve the prognosis of those patients.

Patients and Methods: This was a placebo controlled randomized prospective study, included cohorts of 40 diabetes elderly patients who got infected with SARS-CoV-2 compared with 16 elderly diabetes patients matched of the same age group who got infected with SARS-CoV-2 but given a placebo instead intramuscularly were used as a control. Clinical, laboratory, treatment, and outcome data were recorded after six weeks of follow up especially ICU admissions and fate of COVID-19 disease.Vitamin D was given as a single intramuscular injection during period of the study.

Eligibility Criteria:
Inclusion Criteria:

- Elderly type II diabetes adult with age more than 60 years males and females having deficient serum vitamin D levels (less than 25 ng/ml).

Diabetes patients recruited to the control group were only included in the study if not known to have cholecalciferol supplementation within last 6 weeks. All elderly vitamin D deficient diabetes patients were diagnosed with COVID-19 when throat-swab specimens for SARS-CoV-2 PCR were positive.

Exclusion Criteria:

* patients with known history of renal stones, diagnosis of hypercalcemia with the past year, baseline serum total calcium more than 10mg/dl, established diagnosis associated with increase the risk of hypercalcemia (e.g. metastatic cancer, sarcoidosis, multiple myeloma, primary hyperparathyroidism), and current vitamin D supplementation

Moreover, other exclusion criteria included those with known malignancy, with organ transplant, and those with known chronic autoimmune diseases and lastly those on systemic steroid for any cause
Early Risk of Asthma in Children Exposed to In-utero Maternal Obesity

This study seeks a better understanding of the pathogenesis of asthma in early life. The aim of this project is to determine whether the offspring of obese mothers at 3 years of life have increased the risk of asthma compared to children whose mothers were not obese and whether this increased risk is associated with a programming altered immune reactivity at birth.

The general objectives of this study are:

1. To determine whether the increased risk of asthma in children born from a pre-pregnant obese mother can be observed at 3 years of life and whether this increased risk associated with altered plasma levels of immune mediators at birth.
2. To explore in children born from pre-pregnant obese mother whether monocyte physiology and M1-M2 polarization present an altered response and expression of asthma-related immune-modulations at birth.
3. To study in neonates born from pre-pregnant obese mother whether the in vitro expression of TNFα, IL12, IL-10 and IL-4Rα in monocytes associates with changes in the DNA methylation status in the promoter regions of those genes.

The study is performed in accordance with the Helsinki Declaration, and the study protocol was accepted by Institutional Review Boards at School of Medicine of the Pontificia Universidad Católica de Chile.

Eligibility Criteria:
Inclusion Criteria:

* Women who receive care in any of the 12 public health care centers in La Florida and Puente Alto and give birth in the Sotero del Río Hospital.
* Singleton pregnancy of fewer than 14 weeks of gestation at the first antenatal visit.
* 18 years or older

Exclusion Criteria:

* Pregnant women with overweight (BMI 25-30) before 14 weeks.
* Women that have a premature birth, cardio-respiratory disorder or neurological defects of the neonate.
* Women that develop gestational diabetes and hypertension during pregnancy
Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®

The purpose of this study is to evaluate the proportion of patients who demonstrate no medical need to discontinue therapy among DMT-naïve patients with relapsing forms of multiple sclerosis after 1 year of treatment with Rebif 44 mcg tiw or with Tecfidera 240 mg bid based on real-world data.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Clinically Isolated Syndrome (CIS) or a relapse remitting multiple sclerosis (RRMS).
2. Age between 18 - 55 years at the time of index.
3. No evidence of prior disease modifying therapy for MS.
4. Initiated treatment with either Rebif or Tecfidera at the time of index. Patient is considered to have initiated treatment if they took at least one dose. Treatment must have been initiated after the product was approved by the FDA.
5. Availability of a high quality baseline MRI brain scan, which must have occurred between 6 months prior to the index date to 2 weeks after the index date.
6. Availability of clinical data in the patient's record for the full study observation period, as defined in the primary objective.

Exclusion Criteria:

1. Pregnant at any time during the study observation period.
2. Presence of pre-existing medical conditions known to be associated with brain pathology (cerebrovascular and neurodegenerative diseases, presence of active alcohol or substance abuse).
3. Patient discontinued initial therapy prior to completing 1 year of treatment due to a reason other than disease activity, tolerability, or safety (e.g. financial, convenience, preference, etc.).
4. Phase III registrational trial patients
Exercise Adherence and Cognitive Decline

The purpose of this study is to conduct a small-scale test of a goals-based program to help people to exercise more and learn what people like or don't like about the procedures. This program is being designed for individuals aged 45-65 from the Black community. Low levels of physical activity are related to health problems such as heart disease, diabetes, and cognitive decline. People of color are more negatively impacted by these conditions and have also historically been underrepresented by research seeking to increase physical activity. The investigators have developed this goals-based exercise promotion program with the help of a Black-led community-based organization (The Gyedi Project) and a Community Advisory Board made up of stakeholders in the Black community, and now the investigators are conducting a trial of its feasibility and acceptability.


Eligibility Criteria:
Inclusion Criteria:

* \<3 incorrect responses on the Pfeiffer Mental Status Questionnaire
* Ages 45-65.
* Consent to be randomized to condition.
* Planning to remain in the Denver metro area for the next two months
* Identify as Black or African American

Exclusion Criteria:

* Currently physically active (i.e., \>90 min/week of moderate PA or \>40 min/week of vigorous PA consistently for the past 6 months).
* On antipsychotic medications or currently under treatment for any serious psychiatric disorder, including Alzheimer's or dementia
* Answers "yes" to 1 or more of the 7 questions of the PAR-Q+
* Blood pressure at baseline or before exercise is greater than 140/90
* Blood pressure \>210/90 mmHg (for men) or \>190/90 mmHg (for women) immediately after exercise
* Inability to walk 3 blocks without chest pain, shortness of breath, or light headedness.
* Inability to climb 2 flights of stairs without chest pain, shortness of breath, or light headedness.
Long-Term, Open-Label Study Of CP-690,550 For Treatment Of Rheumatoid Arthritis In Japan

The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are only eligible for this study after they have completed participation in another "qualifying" study of CP-690,550.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have completed their participation in a randomized "qualifying" study of CP-690,550 for the treatment of rheumatoid arthritis

Exclusion Criteria:

* Serious medical conditions that would make treatment with CP-690,550 potentially unsafe
SA4Ag Safety, Tolerability, and Immunogenicity Study in Japanese Adults

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of a single dose of Staphylococcus aureus 4 antigen vaccine in Japanese adults aged 20 to \<86 years.


Eligibility Criteria:
Inclusion Criteria:

1. Japanese male and female adults aged 20 to \<86 years,
2. Determined as healthy by the investigator (Subjects with preexisting chronic medical conditions determined to be stable may be included),
3. Must be available for the 12 month duration of the study,
4. Subjects must agree to use an acceptable method of birth control for 3 months after study vaccination (if the subject or the subject's partner are/is capable of having children).

Exclusion Criteria:

1. Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components,
2. Unstable or serious chronic medical condition that would increase the subject's risk of participation,
3. Immune system suppression or treatment with medications that suppress the immune system,
4. Receipt of blood products or immunoglobulins within the past 12 months,
5. Any infection proven or suspected to be caused by S.aureus within the past 6 months,
6. A staff member at this site nor a relative of those site staff members, nor a sponsor's employee directly involved in the conduct of this research study,
7. Living in a nursing home, long-term care facility or other institution or requiring any types of nursing care,
8. A pregnant or a breast feeding woman.
Menstrual Cycle Hormones and Eating Behavior

The purpose of this study is to determine if the phase of the menstrual cycle (opposed versus unopposed estrogen phase) affects eating behavior, including types of foods preferred, wanting/desire for specific foods, and perception of hunger.

This is an observational study to investigate the effect of endogenous estrogen (E2) and progesterone (P4) levels on eating behavior and energy-yielding nutrient metabolism. Eating behavior will be assessed during a complete menstrual cycle during the first month of the study. Participants will track the follicular and luteal phases of their menstrual cycle using urinary leuteinizing hormone (LH) kits, they will record information about their food intake, eating behaviors, and appetite in their home environments, and they will complete two laboratory test days: one test day scheduled during their follicular phase, and one test day scheduled during their luteal phase.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index between 20-30 Kg/m2
* regular menstrual cycles
* sedentary lifestyle (physical activity not more than 30 minutes per day three times a week)

Exclusion Criteria:

* Fasting blood sugar greater than 110 mg/dL
* Systolic Blood Pressure greater than 140 mmHg
* Diastolic Blood Pressure greater than 90 mmHg
* Fasting triglycerides greater than 120 mg/dL
* Documented or self-reported chronic disorders such as arthritis, or other inflammatory diseases
* Women who are Post-menopausal or Peri-menopausal
* Pre-menopausal women who are pregnant, uni/multiparous, taking oral contraceptives, or who have menstrual cycles lasting less than 20 days or greater than 45 days, polycystic ovary syndrome (PCOS), amenorrhea, eumenorrhoea, or polymenorrhoea.
Substitution of Sulfonylureas With New Generation of Hypoglycemic Drugs for the Treatment of Type 2 Diabetes Mellitus

This is a multicentric, prospective, parallel groups study. Patient recruitment will be carried out at the U.O. Departmental Endocrinology and Diabetology ASST FBF Sacco, Fatebenefratelli and Ophthalmic Hospital, and at the SSD of Endocrine Diseases and Diabetology ASST FBF Sacco, L. Sacco Hospital.

At the screening visit, patients being treated with sulfonylureas / glinids will be shifted, depending on the subject's biochemical and phenotypic characteristics, based on current prescribing criteria and diabetes complications, to one of 4 different types of treatment:

1. GROUP 1: SGLT2 inhibitors +/- Metformin
2. GROUP 2: DPP4 inhibitors +/- Metformin
3. GROUP 3: GLP1-RA + Long-acting insulin +/- Metformin
4. GROUP 4: SGLT2 inhibitors + DPP4 inhibitors +/- Metformin At the screening visit the clinician will evaluate which new treatment to assign to the patient, based on the subject's biochemical and phenotypic characteristics, current prescribing criteria and existing complications (Algorithm for the treatment of diabetes mellitus, SID-AMD Care Standard 2018)

Approximately 500 T2DM patients aged ≥18 years will be enrolled according to the guidelines of the American Diabetes Association (ADA) with poor glycemic control (hemoglobin A1c \[A1C\] ≥6.5% and ≤11% \[≥58 mmol / mol and ≤97 mmol / mol\]), in stabilized treatment with sulfonylureas / glinids, which meet all the study enrollment criteria.

During the study 7 visits are scheduled which coincide with the routine diabetic visits.

During the scheduled visits the patients of the study will be subjected to:

* Enrollment on the first visit if the inclusion criteria are met and those of exclusion are absent
* Anamnestic and clinical collection
* Evaluation of the type of treatment to which they have been assigned and possible modification of drug therapy in the in case that the desired glycemic target has not yet been reached up.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years;
* 6.5% \<HbA1c \<11%;
* Diagnosis of type 2 diabetes mellitus;
* Active treatment with sulfonylureas / glinids, both in monotherapy and in association with other long-acting hypoglycemic / insulins.
* Written informed consent of the patient or a legal guardian signed and dated

Exclusion Criteria:

* Patients suffering from severe systemic diseases, fever, known chronic inflammatory states
* PCR determinants\> 10 mg/L;
* HbA1c\> 11% or HbA1c \<6.5%;
* Use of corticosteroids at the time of enrollment;
* Poor patient understanding of spoken and written Italian;
* Absent compliance.
Evaluation of ZK 6032924 in Probable Alzheimer's Disease Patients Versus Healthy Volunteers and the Radiation Dosimetry of ZK 6032924 in Healthy Volunteers

PET (positron emission tomography) imaging with BAY85-8101 (ZK 6032924) in patients with Alzheimer's Disease compared to healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:Patients for brain imaging:- patient and designee capable of giving fully informed consent in writing- patient fulfils DSM-IV and NINCDS-ADRDA criteria for probable Alzheimer's disease. Other forms of dementia excluded- males or postmenopausal females aged \>/= 50 yearsHealthy volunteers for brain imaging: - able to give fully informed consent in writing- absence of any sign of dementia/cognitive impairment in neuropsychological examinations- males or postmenopausal females aged \>/= 50 years Healthy volunteers for whole body imaging:- able to give fully informed consent in writing - males or postmenopausal females aged \>/= 60 years - no significant disease or drug use Exclusion Criteria:For all healthy volunteers and patients:- Any disease, condition, or concomitant medications that significantly compromises the function of the body systems and could result in excessive accumulation, impaired metabolism, altered excretion of the radiotracer, or might interfere with the conduct of the study or interpretation of the results
The Impact of Artificial Intelligence Dietary Smartphone Application on Nutritional Status Among Cancer Patients

Multi-center prospective pilot trial study

This is a clinical study to evaluate impact of dietary smartphone application on nutritional status among cancer patients. the study hypotheses there is improvement in nutritional outcome in intervention group if compare with control group. the eligible subjects will be screened according to inclusion criteria and approached individually to participate in this study. The consented subjects will be divided randomly into two groups, intervention and conventional groups. Conventional dietitian care will be given to conventional group (CG) while intervention group (IG) will received innovated dietitian care where they will be introduced with iDSA apps and installed in consented subjects' smartphone. All subjects will be reviewed again by dietitian in 1-month time to assess nutritional status (weight and energy protein intake) as well as nutrition impact symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Possessing smartphone and is willing to use smartphone application
* Been referred to dietitian in outpatient clinic
* At least 18 years of age
* Malaysian

Exclusion Criteria:

* Inability to use the smartphone application (eg. due to vision problems)
* Not been referred to dietitian in outpatient clinic
* Patients who participate in other study at the same time
* On nutrition support (enteral / intra-venous)
* Vulnerable subjects
Adult Growth Hormone Deficiency and Cardiovascular Risk

This protocol will assess the cardiovascular risk associated with growth hormone deficiency in adults. We will use multiple modalities to assess risk for heart attacks or strokes including blood work, ultrasound, MRI and endothelial cell biopsies in both patients who are growth hormone deficient and in patients with normal growth hormone secretion. We hypothesize that adults with growth hormone deficiency will have results suggestive of an increased risk for cardiovascular disease.

Subjects will first be tested for possible growth hormone deficiency. This will be done by administering two intravenous medications that should stimulate growth hormone secretion and we will measure growth hormone in the blood every 30 minutes following the administration. Once we have the results on enough subjects we will split the cohort into those subjects who are growth hormone deficient and those who have normal growth hormone. The two groups will each undergo various tests all designed to assess some component of cardiovascular risk. Ultimately we will compare the results of each test to see if those who are growth hormone deficient have an increased risk for cardiovascular disease.

Eligibility Criteria:
Inclusion Criteria:

* Adults 19 years or older who have undergone transsphenoidal surgery for a clinically non-secreting pituitary adenoma

Exclusion Criteria:

* Currently taking growth hormone, radiation therapy in the past 5 years, changes in dose of other pituitary hormone replacement therapy in past 3 months, taking hydrocortisone (or its equivalent) at a dose of \> 30 mg/day, pregnant or nursing women