cyrilzakka/clinical-trials huggingface dataset:
Treatment of Anemia in Patients With Cancer Who Are Not Currently Receiving Chemotherapy or Radiotherapy

The purpose of this study is to determine the effectiveness of different doses of epoetin alfa for treating anemia in patients who have cancer; or patients who no longer have any signs of cancer, but remain anemic as a result of their treatment. These patients should not be currently receiving chemotherapy or radiotherapy. A subject's participation in the study will last approximately 6 months. Subjects will receive weekly doses of epoetin alfa or placebo. Their hemoglobin will be tested every week.


Eligibility Criteria:
Inclusion Criteria:

* Body weight \>/=99 lbs
* ECOG 0-2
* Anemia results from cancer, chemotherapy, radiotherapy or an association with hormonal therapy or immunotherapy
* Screening hemoglobin level of \</=11.0 g/dL for men or \</=10.0 for women
Youth mHealth Adherence Intervention for HIV+ YMSM

This study will help determine feasibility, acceptability, and preliminary efficacy of an app for HIV medication adherence over a 3-month period. Participation is 3 months consisting of two study visits: An initial study visit and a 3 month follow up visit with both visits lasting about 60-90 minutes. The participant must use the study application (app) at least once daily, and at study visits, must complete surveys.

Young men who have sex with men (YMSM) are disproportionately affected by HIV in the US and fewer than half of youth who are prescribed antiretroviral therapy (ART) achieve viral suppression. Yet few interventions have been developed to address adherence in this population with unique developmental/psychosocial needs. Mobile technology, which is constantly consumed by youth, has the potential to deliver interventions that provide support and feedback in real time as youth go about their daily lives.

This pilot study will test a theory-driven, patient-centered, mobile phone-based intervention (mHealth app) targeting medication adherence among HIV+ youth. It is a three-month prospective feasibility trial to test a medication adherence mobile application consisting of two study visits: baseline and 3-month follow up.

Data collection consists of app usage, Computer Assisted Self-Interview (CASI) for participant satisfaction with the app, demographics, and mental health and risk behaviors, as well as medical chart abstraction of disease biomarkers (CD4, viral load) and pharmacy refill data.

Eligibility Criteria:
Inclusion Criteria:

1. Males (sex at birth male) age 14 to 24 years.
2. HIV-positive
3. Owns an Android smart phone
4. Within 1-month of initiating antiretroviral therapy (ART) medication, previously failed ART and about to restart an ART regimen, or currently on ART having trouble with adherence (defined as having a detectable viral load above 200 copies/ml).
5. MSM (men who have sex with men)
6. Receiving care at the Children's Hospital of Philadelphia (CHOP) Adolescent HIV clinic at the time of the study

Exclusion Criteria:

1. Females (sex at birth; not gender)
2. Males age 13 years or younger or 25 years and older.
3. HIV-negative or status unknown
4. Not in care at the CHOP Adolescent HIV clinic at the time of the study.
5. Does not own an Android smart phone (iPhone, Blackberry, etc. phone users)
6. Is already ART adherent (defined as having an undetectable or suppressed, \<200 copies/ml, viral load) or is not on or going to be on ART during the study period.
Metformin Versus Vildagliptin for Diabetic Hypertensive Patients

This is a controlled study to measure the efficacy of using metformin or vildagliptin for type 2 diabetic patients who suffers from hypertension to reduce cardiovascular risk resulting from both diabetes and hypertension using different parameters measuring

Several studies indicated that type 2 diabetes mellitus and hypertension are associated with increased cardiovascular complications. Recently, studies suggest that metformin and vildagliptin can reduce cardiovascular complications in diabetic patients with unclear mechanisms. This work aimed to determine the effect of metformin and vildagliptin on diabetic-hypertensive patients. Patients were allocated into four groups: groupI: healthy volunteers, groupII: patients recently diagnosed with their hypertension and diabetes, groupIII: patients treated with captopril (25mg once daily) for their hypertension in addition to metformin (1000mg bid) groupIV: patients treated with captopril (25mg bid) for hypertension in addition to vildagliptin (50mg bid). At the end of the therapeutic period, then total cholesterol, LDL,serum Creatinine level, blood pressure and vascular endothelial growth factor (VEGF) levels in serum will be measured for different groups to estimate the benefits of one drug over the other one in protecting against cardiovascular risks for diabetic hypertensive patients..

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from moderate HTN and DM, their HbA1c ≥ 7 and age range between 40-60 years, treatment with diet alone, any combination of oral antidiabetic agents and/or insulin before admission

Exclusion Criteria:

* Clinical evidence of ischemic heart disease, chronic obstructive pulmonary disease, presence of diabetic ketoacidosis (DKA), patients admitted to intensive care unit (ICU), subjects expected to undergo surgery during the study period, patients with clinically relevant hepatic disease, impaired renal function (serum creatinine ≥3.0 mg/dL), systemic infections or pregnancy. Also, patients on medications known to interfere with the blood glucose level (either increasing or decreasing) were excluded from the study.
A Nurse Led Intervention to Promote Physical Activity

Regular physical activity should be the essence of treatment in patients with cardiovascular risk factors. Unfortunately, these interventions are usually insufficiently promoted and therefore have only limited efficacy. The aim of the study was to determine the benefits of nurse led intervention to promote physical activity in sedentary older adults with cardio-vascular risk factors in the outpatient setting. Eligible patients are randomized in a 1:1 fashion to receive nurse led tutorial on life-style modification including pedometer hand-out with a daily goal of at least 7000 steps and supporting phone calls (study group) or without a goal or calls (control group). The primary end-point of the study is change in body weight. Secondary end-points include changes in resting heart rate, systolic and diastolic blood pressure, total cholesterol and fasting glucose and clinical outcomes at 3 months follow-up.


Eligibility Criteria:
Inclusion Criteria:

* sedentary lifestyle defined as mean walking distance per day of no more than 3 km as reported by the patients;
* history of at least one of the following conditions: obesity (defined as body mass index ≥30 for I st degree obesity, ≥35 for second degree obesity and ≥40 for third degree obesity), hypertension, diabetes mellitus, dyslipidemia, stable coronary artery disease with or without prior myocardial infarction, peripheral arterial disease, stable arrhythmias, heart failure and/or prior stroke.

Exclusion Criteria:

* unstable clinical condition (in the form of unstable coronary artery disease or peripheral arterial disease, unstable heart failure or unstable arrhythmias);
* inability to undertake physical activity due to orthopedic reasons or other disabilities;
* planned changes in pharmacological treatment during the study period;
* lack of will to participate in the study and to sign the the written informed consent for the participation in the study.
Noninvasive Diagnostic Techniques in Determination of Site of Lesion of Auditory Neuropathy Spectrum Disorder

cross-sectional study of population who have ANSD

Cross-sectional nonivasive study including study and control group aiming to determine site of lesion of auditory neuropathy spectrum disorder either presynaptic or postsynaptic by using electrophysiological measures

Eligibility Criteria:
Inclusion Criteria:

* Age between 12 and 50 years OAE and CM could be present disproportionate SRS to PTA level

Exclusion Criteria:

proportionate ABR to PTA level Proportionate SRS to PTA level

* presnce ol lesions in CT or MRI
Attention Deficit Hyperactivity Disorder (ADHD) Prediction of Treatment Response

This is a 6-month trial in adults to find out if certain neuromarkers can predict individual treatment response to stimulant medications for Attention Deficit Hyperactivity Disorder (ADHD). Males and females, ages 18-45, will complete an MRI scan at MIT prior to beginning medication for ADHD as determined by a treating clinician outside the context of this study.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adults ages 18-55
* A diagnosis of DSM-V ADHD based on clinical assessment supported by the ADHD module of a structured diagnostic interview
* Proficiency in English
* Right-handed

Exclusion Criteria:

* Any contraindication for the use of a stimulant medication
* Investigator and his/her immediate family (spouse, parent, child, grandparent, or grandchild)
* Any contraindications for MRI examination (metallic implants, such as pacemakers, surgical aneurysm clips, or known metal fragments in the body)
* Women who are currently pregnant or breastfeeding, as confirmed by a urine pregnancy test
* Clinically significant abnormal baseline laboratory values, including systolic and diastolic blood pressure parameters above 140 and 90, respectively and resting heart rate outside 60-100 bpm
Human Leukocyte Antigen (HLA) Class I Haplotype Mismatched Natural Killer Cell Infusions

The purpose of this research study is to examine the safety of infusing escalated doses of allogeneic (from a relative of the patient), enriched natural killer (NK) cells after autologous (from the patient) stem cell transplantation. The hypothesis is that the infusion of these NK cells early after an autologous stem cell transplant will help to eliminate and eradicate any residual cancerous cells that remain in the body and may have survived the chemotherapy or radiation.

Natural killer cells are blood cells that are responsible for eliminating cancer cells especially when there are only a few. It has been shown that NK cells coming from a "mismatched" person (a relative) have a better chance than the patient's own NK cells to recognize and kill cancer cells. These cells will be collected from the blood of a parent, child or sibling and after preparation in the laboratory, will be given to the patient early after an autologous stem cell transplantation like a blood or platelet transfusion. A person who has been diagnosed with a blood tumor and received an autologous stem cell transplant has the chance of his/her cancer coming back. This study uses NK cells obtained from a relative to prevent disease recurrence by potentially eliminating and eradicating any residual cancerous cells.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone an autologous stem cell transplant for the following diseases:

  * Acute Myeloid Leukemia
  * Non-Hodgkin's Lymphoma
  * Hodgkin's Disease
  * Multiple Myeloma
* Age 13 - 70 years old
* Able to give informed consent
* Hepatic and renal function: bilirubin less than or equal to 2x normal limits, AST and ALT less than or equal to 2x normal limits, serum creatinine less than or equal to 1.5x normal
* ECOG Performance Status less than or equal to 1 (at planned time of transplantation)
* Patients with no active infection

Exclusion Criteria:

* Patients who have not recovered sufficiently from the side effects of the autologous transplant (i.e. have \> grade 2 toxicity in any organ system)
* Patients who have insufficient engraftment parameters according to the following criteria: WBC \< 2,500 /mm3 and platelets \< 50,000/mm3
* Radiation therapy, chemotherapy, or immunotherapy beginning one week before NK-cell infusion and lasting 2 weeks after NK-cell infusion.
* Intrinsic impaired organ function (as stated above).
* Physical or psychiatric conditions that in the estimation of the PI or designee place the patient at high-risk of toxicity or non-compliance.
* Uncontrolled, life-threatening infections at the time of infusion.
* Concurrent treatment with corticosteroids and/or other immuno-suppressive drugs.
Autologous Cord Blood Transfusion in Preterm Infants

The purpose of this study is to investigate the efficacy and safety of autologous cord blood transfusions in very-low-birth-weight premature infants, and to evaluate the developmental outcomes of the infants who received autologous transfusions.

Blood transfusions have many risks including transfusion reactions and infections. Cord blood is accepted as an alternative method for red cell transfusions in low-birth weight (LBW) premature newborns. However, experience and scientific evidence concerning in-vivo efficacy and safety of red blood cell (RBC) concentrates derived from cord blood in very LBW premature newborns is still insufficient.

A total of 50 umbilical cord blood (UCB) collected from infants born before 32 weeks' gestational age and processed into autologous RBC products. Infants requiring blood transfusion were randomly assigned to an autologous or allogeneic product. Two randomized groups were compared on the 14th, 28th, 35th days and \>35th days with respect to hemoglobin levels, transfusion numbers, transfusion and phlebotomy volumes, and hemoglobin, reticulocyte counts and erythropoietin levels in the postconceptional 36th and 40th weeks' gestation, and hemoglobin levels at postnatal 6-months age. All transfused infants were developmentally assessed by the end of the postnatal first year.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants born at ≤ 32 weeks gestational age
* Parental consent

Exclusion Criteria:

* rhesus incompatibility
* hydrops fetalis
* maternal viral or bacterial infections including suspected chorioamnionitis
* parental refuse
Impact of Soft Contact Lenses on Lid-Parallel Conjunctival Folds

The aim of the study is to investigate how Lid-Parallel Conjunctival Folds recovers or persists after the continued usage or discontinuation of contact lenses or refitting with low coefficient of friction lenses.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must read, understand and sign the statement of informed consent and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. The subject must be 18 years old.
4. The subject's contact lens correction must be in the range of -12.00 to +8.00 in each eye.
5. The subject's refractive cylinder must be less than 1.50D in each eye.
6. The subject must have best visual acuity of 20/40 or better in each eye.
7. The subject must demonstrate adequate mobility and 20/40 vision OD and OS with their habitual contact lenses.
8. The subject must be an adapted soft contact lens wearer in both eyes with at least 1 year experience in contact lens wear.
9. The subject must have normal eyes (i.e. no ocular medications or infections of any type).
10. The subject must have Lid-Parallel Conjunctival Folds greater than or equal to grade 1 OD or OS.

Exclusion Criteria:

1. Currently self reported pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear. This may include, but not be limited to, ocular/systemic pathology or allergy known to affect the conjunctiva, Sjogren's Syndrome, rheumatoid arthritis, diabetes, infections, hay-fever, or if they have had ocular surgery.
3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
5. Any previous, or planned ocular or intra-ocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
6. Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection)on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g. past peripheral ulcer or round peripheral scar), or any other abnormality that may contraindicate contact lens wear.
7. Any ocular infection.
8. Monovision or multi-focal contact lens correction.
9. Participation in any contact lens or lens care product clinical trial within 90 days prior to study enrollment.
10. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV,by self report).
11. Employee of the investigational clinic (e.g. Investigator, Coordinator, Technician)
12. Contact lens wearing of OASYS or TruEye lenses
13. Contact lens wearing time less than 6h/day and/or 5 days/week
14. Extended wear of contact lenses.

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Study to Evaluate Drug-drug Interaction Between Valopicitabine and Ribavirin

This study is being conducted to see if the investigational medication, valopicitabine, is safe to use in combination with ribavirin, a drug approved by the FDA for treating hepatitis C infection.


Eligibility Criteria:
Inclusion Criteria:

* Documented clinical history compatible with chronic hepatitis C and compensated liver disease
* Has not previously received anti-viral therapy for hepatitis C infection

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Patient is pregnant or breastfeeding
* Patient is co-infected with hepatitis B virus and/or HIV

Other protocol-defined exclusion criteria may apply.
The Effect of Home-Based Walking Program on Peripheral Neuropathy, Fatigue and Quality of Life

The study aims to evaluate the effect of home-based walking program on peripheral neuropathy, fatigue and quality of life in patients receiving taxane and platinum-based chemotherapy.

The study was designed as a randomized controlled trial. This study will be carried out with a total of 86 cancer patients receiving taxane and platinum-based chemotherapy, 43 of whom were in the intervention group and 43 in the control group, whose treatment was started in Akdeniz University Hospital."Home Based Walking Program" will be applied to the patients in the intervention group for 8 weeks.Within the scope of the Home-Based Walking Program, face-to-face patient education, patient education booklet, sending text messages, face-to-face and telephone counseling were planned.

Patient Identification Form, International Physical Activity Questionnaire (IPAQ- Short Form), National Cancer Institute (NCI) -CTCAE v5.0 Toxicity Criteria, Cancer Fatigue Scale, EORTC QLQ-CIPN20 (Quality of Life Chemotherapy-Induced Peripheral Neuropathy) and EORTC QLQ-C30 (Quality of Life Scale), Interview Form will be used to collect data.

Eligibility Criteria:
İnclusion Criteria

* 18 Years and older (Adult, Older Adult )
* Turkish speaking-understanding ability and literate.
* Orientation (person, place, time)
* Receiving taxane and platinum-based chemotherapy treatment (monotherapy or combined).
* Receiving chemotherapy treatment for the first time.
* The primary medical diagnosis is cancer (breast cancer, colorectal cancers and other cancers).
* Not having health problems that prevent walking.
* Agreeing to participate in the research.

Exclusion Criteria

* Being bone and brain metastases
* Being peripheral neuropathy due to reasons other than chemotherapy (such as chronic disease, diabetes mellitus, nutritional disorders)
* Skin sensitivity on the hands and feet
* Having cardiovascular, pulmonary, musculoskeletal, or psychological disorders that limit exercise or mobility
* Being in another supportive program
* Being in the very active category according to the "International Physical Activity Scale (IPAQ- Short Form)"
* Being a severity of more than 4 points according to the "Modified Borg Scale (MBS)"
* Being a score of 2 and above according to the "ECOG Performance Scale"
Assessment of Quality of Life After Adjunct Radioiodine Therapy in Patients With Differentiated Thyroid Cancer

The aim of this study was to assess the impact of adjuvant radioactive iodine therapy on the quality of life(QOL) in differentiated thyroid cancer patients and to identify independent factors affecting changes in the QOL.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed new diagnosis of differentiated thyroid cancer, recently treated by total thyroidectomy
* Must sign a consent form before treatment
* One year or more of follow-up after radioiodine ablation

Exclusion Criteria:

* Patients with follicular, Hürthle cell, poorly differentiated, medullary, or anaplastic thyroid carcinoma
* Pregnant or lactating women
* Patients that received adjuvant radioiodine treatment in the past
* Patients with other cancer
The Role of Human Milk Oligosaccharides and Microbiomes on Infantile Colic and Atopic Dermatitis in Term Infants

Background: Human milk oligosaccharides (HMO) and microbiota are both key factors for infants to shape the gut flora and develop the immune system. Breastfed infant is beneficial to prevent the occurrence of infantile colic (IC) and atopic dermatitis (AD), which may through shaping a healthy microbiota. However, the gut microbiota biomarkers representing IC and AD have not yet been discovered. In addition, the effectiveness of supplement of HMO in infant formula reduce the incidence of IC and AD in infants is still debate.

Purpose: To investigate the preventive role of HMO-supplement formula on IC and AD in term infants in a clinical trial.

Method: The investigators will enroll three cohorts (exclusive breastfeeding, formula feeding, and HMO-supplement formula feeding infants) for research. The investigators collected samples of serial baby feces from subjects at 0, 1, 2, 4, 6, 12 months in this study. The fecal microbiota composition will be analyzed by detecting 16S-rRNA using next generation sequencing method. The demographic data and incidence of IC (0-5 months) and AD (0-12 months) was followed and recorded.

Eligibility Criteria:
Inclusion Criteria:

1. New born
2. Gestational age of \>= 37 weeks
3. birth weight greater than 2500 gm

Exclusion Criteria:

1. Born with Perinatal insults
2. Mother with antimicrobial agents 1 month before delivery
3. Congenital abnormalities related to growth
4. Major disease admitted to Level II or NICU
Optical Tissue Identification for Myocardial Architecture

The goal of this study is to test the hypothesis that fiberoptic confocal microscopy (FCM) imaging during repair of common congenital heart defects is a useful adjunct for avoidance of conduction abnormalities.

This is an interventional randomized controlled study to investigate the use of fiberoptic confocal microscopy (FCM) imaging for avoidance of conduction abnormalities during repair of common congenital heart defects. Study results will be compared to a cohort of similar surgical patients following standard surgical procedures where FCM was not used. We will analyze pre-and postoperative ECGs to identify conduction abnormalities.

Eligibility Criteria:
Inclusion Criteria:

* Age 30 days to less than 18 years old
* Patients with planned surgical repair of:
* Ventricular septal defect (VSD)
* Complete atrioventricular canal (CAVC)
* Tetralogy of Fallot (ToF) with pulmonary stenosis

Exclusion Criteria:

* Prior history of adverse reaction to fluorescein sodium
* Prior history of renal failure or abnormal renal function
* Baseline PR interval \> 220 msec or 98% for age
* Baseline HR \> 98% for age
* Underlying genetic syndrome associated with progressive AV block or sinus node dysfunction (e.g. Holt-Oram or NKX2.5)
* Any surgical repair that requires staging or palliation
* Pregnant or lactating
* Exclusions specific to type of surgical repair
* Apical muscular VSD
* ToF with pulmonary atresia