cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection

This study will have two parts as follows:

The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and confirm the dose of sofosbuvir (SOF) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the safety and tolerability of 7 days of dosing of SOF+ribavirin (RBV) in HCV-infected pediatric participants.

The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate SOF dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the Treatment Phase with no interruption of study drug administration. The Treatment Phase will evaluate the antiviral efficacy, safety, and tolerability of SOF+RBV for 12 or 24 weeks in pediatric participants with genotype 2 or 3 HCV infection, respectively.


Eligibility Criteria:
Key Inclusion Criteria:

* Consent of parent or legal guardian required
* Chronic HCV infection genotype 2 or 3
* Screening laboratory values within defined thresholds
* PK Lead-in only: all individuals must be treatment naive

Key Exclusion Criteria:

* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
* Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus
* Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)
* Pregnant or nursing females
* Known hypersensitivity to study medication
* Use of any prohibited concomitant medications as within 28 days of the Day 1 visit

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Retrospective Review of Infections Usually Observed in Transplant Recipients

The study will identify patients with infections commonly observed in transplant recipients, describe the epidemiology of their infection, study the risk factors associated with various infections and examine strategies of early diagnosis and prevention of infection

The following variables will be followed: time and location of positive cultures, underlying diseases and severity of illness, recent immunomodulative therapies, physical exam findings, previous medical surgical conditions, microbiology and virology culture results, laboratory and radiographical data, antimicrobial usage of onset of infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, suspected source of infection, bacteriological outcomes, laboratory results, demographic information, pathology and histology results, summaries of admissions, discharges, operations, death, medications, clinical outcome gender, height, weight, ethnicity, date of transplant, type of transplant, primary diagnosis, and past medical history. Also required are medical summaries of admissions, discharges, operations, and deaths

Eligibility Criteria:
Inclusion Criteria:

* Patients who receive medical care at UPMC
* Patients who developed infections usually observed in transplant recipients

Exclusion:

* Patients who do not receive medical care in UPMC Oakland campus
This Is An Open-Label Study To Evaluate Fesoterodine Plus "Your Way" Patient Support Plan In Patients With Symptoms Of Overactive Bladder

The primary objective of the study is to assess the level of medication adherence observed among subjects receiving a specific combination of education and support materials (YourWay plan) along with a prescription for fesoterodine.

This is a non-interventional, observational study. Study investigators will recruit symptomatic, fesoterodine-naïve subjects when they present with OAB symptoms during regularly-scheduled physician visits fesoterodine-naïve subjects with OAB symptoms present during regularly-scheduled physician visits

Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients \>=18 years old
* Eligible for receiving Toviaz 4mg or 8mg QD treatment based on the approved US label.

Exclusion Criteria:

* Female subjects who are pregnant, lactating, or who are intending to become pregnant within 28 days after the completion of the study (use of contraceptives is not required to participate in the study)
* Have participated in any other studies involving study drugs within 30 days prior to entry in the study
* Subjects who have previously taken fesoterodine.
Surveillance Study of Bacterial Contamination of the Parent's Cell Phone in the NICU

The purpose of this study is to determine the contamination rate of the parents cell phone in a newborn intensive care setting and identify the types of bacteria contaminating the cell phone as well as evaluating the effectiveness of an antimicrobial gel in reducing the transmission of bacteria from the cell phone to the parents hands.

J Perinatol. 2013 Dec;33(12):960-3. doi: 10.1038/jp.2013.108. Epub 2013 Sep 5.

Eligibility Criteria:
Inclusion Criteria:

* Parents with a cell phone

Exclusion Criteria:

* Parents that do not have a cell phone
Serratus Plane Block After Minimally Invasive Mitral Valve Repair

Patients undergoing minimally invasive mitral valve reconstruction via small thoracotomy are randomized into two groups.

The intervention group receives serratus anterior plane block after minimally invasive mitral-valve reconstruction, following 48h infusion with ropivacaine 2% continually.

The control group receives a placebo pump without infusion. Primary endpoints are perceived pain using a numeric pain rating scale and opioid consumption during the hospital stay.


Eligibility Criteria:
Inclusion Criteria:

-Planned minimal invasive mitral valve repair via right anterior thoracotomy

Exclusion Criteria:

* Pregenancy
* Opioid abuse
* Historyof chronic pain
* Allergy to local anaesthetics (in this case ropivacain)
* Patients who simultaneously participate in another interventional clinical trial, unless the Principal Investigators of the clinical trials give consent by mutual agreement Soft tissue infection in the area of the procedure
A Pilot Study for the Treatment of Iris Neovascularization With Macugen

The purpose of this study is to determine if a drug called Macugen may help to stop the growth of abnormal blood vessels on the iris that has occurred in the eye(s) as part of diabetic retinopathy.

Diabetic retinopathy is an eye condition caused by diabetes in which new blood vessels grow on the retina (the back, inside part of the eye) and the iris. These vessels are not normal and may leak or break, causing bleeding in the eye. This process can lead to vision loss or blindness, glaucoma (disease of the eye where eye pressures are usually too high resulting in damage to the optic nerve), or other eye problems. This study is to determine if a drug called Macugen may help to stop the growth of these abnormal blood vessels on the iris.

Eligibility Criteria:
Inclusion criteria:

1. Male or female, at least 18 years of age
2. Diabetic retinopathy with iris neovascularization
3. Visual acuity must be light perception or better in the study eye
4. Female patients of childbearing potential must have a negative urine pregnancy test at the screening visit.
5. Written informed consent has been obtained
6. Written authorization for use and release of health and research study information has been obtained

Exclusion criteria:

1. Neovascular glaucoma ( a difficult form of glaucoma to control that leads to a painful eye with high intraocular pressure, corneal swelling, and "cell and flare" in the anterior chamber. Caused by abnormal new blood vessel formation (neovascularization) on the iris, that extends over trabecular meshwork causing closure of angle drainage structures).
2. No light perception in the study eye.
3. Inadequate view of retina for PRP/angiography
4. Anterior chamber intraocular lens implant
5. PRP treatment in the past 60 days. Patients may participate if the PRP treatment is beyond 60 days and has newly diagnosed NVI or has nonregression of previously diagnosed NVI.
6. Previous or current Macugen use
7. Any active ocular infection
8. Any conditions which precludes patients ability to comply with study requirements including completion of the study
9. Female patients who are pregnant, nursing, or planning pregnancy, or who are of childbearing potential and not using a reliable means of contraception
10. Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to screening
11. Patient has a condition or is in a situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results or may interfere significantly with the patient's participation in the study
The Primordial Dwarfisms: Diagnosis, Identification of the Molecular Basis of Seckel Syndrome and Microcephalic Osteodysplastic Primordial Dwarfism Type II

The purpose of this study si to define morphological and epidemiological parameters and identify new symptoms in French patients with Seckel syndrome (SCKL) or microcephalic osteodysplastic primordial dwarfism type II (MOPDII).

Multicentre study, aiming to determine morphological and epidemiological parameters and identify new symptoms in French patients with SCKL or MOPDII.

At pre-inclusion visit: Realization of the photographs of: the face, entire body and the extremities (hands and feet) that will be serve for the collegiate decision of the inclusion or not of patients.

Patients are seen at inclusion V1 , a second visit V2 at 6-10 months after V1 and an annual follow-up visit.

At inclusion:

* Full Clinical Examination, specialized consultations (Otorhinolaryngology, stomatology, orthopedics, ophthalmology)
* Results of x-ray examinations and biological tests
* Assessment of the patients competencies and initiation of appropriate care ( orthophony and psychomotricity...)
* Assessment of intelligence and cognitive ability according the WISC-IV scale
* Blood testing for diagnosis and research.

Visit 2:

* Full Clinical Examination
* Cerebral angiography-MRI for all patients
* Programming a neurosurgery / neurovascular consultation based on MRI results
* Immuno-hematology and hepato-gastroenterology consultation if anomaly during the visit V1

Annual follow-up visit:

* Assessment of the complications of the disease and its clinical care
* Full clinical examination
* Skeletal x-ray and systematic orthopedic consultation
* Blood Check
* Prescription of tests if necessary depending to the complications identified of the disease
* Reevaluation of the care according to the detected symptoms

Eligibility Criteria:
Inclusion Criteria:

Patients aged from 2 months to 50 years must present all of the following criteria:

* Symmetrical intrauterine growth restriction (IUGR) \< - 2 DS, Birth size \<-2 DS and Cranial perimeter of birth \<-2 DS
* Postnatal growth restriction (size \<-4DS)
* Microcephaly \<-4DS
* Clinical Diagnosis of Seckel Syndrome or Microcephalic osteodysplastic primordial dwarfism type II (MOPDII) by a geneticist
* Having given free and informed consent

Exclusion Criteria:

* Refutation of the diagnosis
* Parents' refusal to participate in genetic studies once the diagnosis of SCKL or MOPDII has been establish for the patient (major or minor)
* Allergy to gadolinium, contraindicating the realization of an Angio-MRI
* Absence of affiliation to a social security scheme or Universal Health Coverage.
Immunophenotyping From Blood of Patients With Malignant Gliomas

In this explorative study immunological changes during tumor therapy will be analyzed in patients with malignant glioma. Immunophenotyping before and during therapy is used as analysis method. Thereby immune cells are quantitatively and qualitatively detected from patient's blood at continuous time points. Additionally relevant mediators like cytokines, danger signals and chemokines are analyzed by other methods. Obtained results may give information about the effects of therapy on immunological processes and immune cells and may help to find immunological based predictive or prognostic tumor markers and to define time points for including additional immune therapy in the future.

Patients with malignant glioma generally have a bad prognosis. To improve patients' situation new therapy options as well as new possibilities to determine prognosis and prediction more precisely are needed. One approach is the targeted activation of the immune system to recognize and eliminate tumor cells. Due to cerebral tumors the brain is no immune privileged organ anymore, so that immune cells may pass the haemato-encephalic barrier to attack tumor cells. This study aims to offer valuable clues about how the immune system is influenced by standard therapies (radiotherapy and chemotherapy). Just with the background knowledge of immune mechanisms and influencing factors by tumor therapy, an effective anti-tumor response can systematically be induced by modulating immune therapy. To analyze immunological changes, immunophenotyping by flow cytometry is performed with blood from patients with malignant gliomas during their therapy concluding chemoradiation and chemotherapy alone. Count, class and activation status of immune cells are detected by flow cytometry. Together with additional analysis methods, information about immunological mediators like cytokines, chemokines and danger signals can be received. For these purposes serum and plasma are generated from blood samples and stored for prospective questions. The explorative determined results may also help to discover new, immunological based, prognostic or predictive tumor markers.

Eligibility Criteria:
Inclusion Criteria:

* patients with glioblastoma or anaplastic astrocytoma
* legal age
* planned chemoradiation and adjuvant chemotherapy (according to Stupp et. al.)

Exclusion Criteria:

* Fertile patients who refuse effective contraception during study treatment
* persistent drug and/or alcohol abuse
* patients not able or willing to behave according to study protocol
* patients in care
* patients that are not able to speak German
To Test Whether Time-restricted Eating Coupled with a Healthy Diet is Beneficial in Liver Cancer Patients

This is a feasibility study that will collect data to assess the potential effect of a nutritional intervention designed to improve liver metabolism. This prospective single-site trial will enroll adult patients undergoing liver-directed therapies for hepatocellular carcinoma. Eligible individuals who are randomized to the intervention group will be enrolled in a six-month nutritional change program consisting of time-restricted eating in which calorie consumption is limited to 8-10 hours during the day, plus targeted healthy changes in what they eat. The intervention includes dietary counseling visits with a study registered dietitian and motivational phone calls with a study Certified Health and Wellness Coach to help subjects adhere to the intervention. Individuals in the control group will be enrolled in a six-month period of observation only. The main questions it aims to answer are:

Is a prolonged nightly fast coupled with a healthy diet safe and feasible for patients with liver cancer? Does the intervention improve liver metabolism?


Eligibility Criteria:
Inclusion Criteria:

1. Overweight or obese (BMI 27-45 kg/m2)
2. BCLC early to intermediate stage HCC
3. Referred for liver-directed therapy (PTA, TACE, TARE within 3 months)
4. English or Spanish speaking over the age of 18.
5. ECOG Performance Status ≤ 2.
6. Usual nightly fasting \<12 hours
7. Willing to comply with all study procedures
8. Child-Pugh A liver function.

Exclusion Criteria:

1. Advanced HCC, progression, and/or associated comorbidities, metastatic disease, tumor in vein, or ascites
2. Advanced Cirrhosis (hypoalbuminemia/Child-Pugh B+C). Poorly controlled or refractory (grade 3-4) hepatic encephalopathy
3. Type 1 diabetes or self-reported hypoglycemia or hypoglycemic events by CGM
4. Participation in another conflicting study that requires modification of diet or food timing.
5. Uncontrollable eating pattern (e.g., wasting, Night Eating Syndrome, disordered eating habits, food insecurity)
6. Medications that markedly impact metabolic study biomarkers.
7. Other cancer in last 10 years (other than nonmelanoma skin cancer or carcinoma of the cervix in situ)
8. Serious medical conditions such as chronic kidney disease, congestive heart failure, or any condition that would interfere with participation in the trial.
9. Unresolved toxicity ≥ CTCAE Grade 2 from previous anti-cancer therapy
10. Active alcohol abuse or less than 6 months of sobriety
11. Participation in a trial of an investigational agent within the prior 30 days
12. Pregnancy or lactating
Niclosamide Role in Diabetic Nephropathy

This study is randomized, controlled, parallel, prospective clinical study will be conducted on 60 patients diagnosed with type 2 diabetes mellitus at least five years ago. Patients will be recruited from Tanta University Hospital, Tanta, Egypt.

Accepted patients will be randomized into 2 groups as the following:

Control group: 30 patients will receive maximum tolerated dose of ACEI plus placebo pills for six months Treatment group: 30 patients will receive maximum tolerated dose of ACEI plus niclosamide tablets 1 gram once daily for six months The primary end point will be the change in Urinary albumin to creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR) after six months of treatment


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 diabetes mellitus at least 5 years ago
* Stage 2 and 3 diabetic nephropathy (persistent micro- or macroalbuminuria with urinary albumin creatinine ratio (UACR) \>30mg/g) despite treatment with maximum tolerated dose of ACE inhibitors for at least 8 weeks prior to the screening
* Hemoglobin A1c \> 6.5 % with regular use of insulin and/or oral glucose lowering agents

Exclusion Criteria:

* Type 1 diabetes mellitus
* Severe renal impairment (eGFR\< 30 mL/min/1.73 m2 at screening)
* Pregnant or lactating women
* Chronic heart failure
* Inflammatory or autoimmune disease
* History of kidney disease other than diabetic nephropathy
Epidural Block Impairs HPV During One-lung Ventilation: an EIT- Based Prospective Observation Study

Define the effect of epidural block on HPV by EIT.

Epidural block may affect the physiological mechanism of hypoxic pulmonary vasoconstriction, which is still poorly understood. Electrical impedance tomography might be helpful in establishing the hypoxemia etiology at bedside via combining regional ventilation and perfusion information.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 80 years Existing central venous and arterial access Chest circumference 70 - 150 cm

Exclusion Criteria:

* Contraindication to central venous injection of 5 % sodium chloride (NaCl)

Contraindications of PulmoVista 500:

Patients with pacemakers, defibrillators or other electrically active implants Patients with damaged skin or impaired skin contact of the electrodes due to wound dressings Patients where the attachment of the patient belt could pose a risk to the patient, e.g. patients with spinal lesions or fractures Patients with uncontrolled body movements Extremely obese patients (BMI\>50) Patients during pregnancy Patients with massive lung edema Use during electricity-based therapies, such as electrosurgery or electrocautery Use in the presence of strong magnetic fields Use in conjunction with other bioimpedance measurement devices
Effect of Gamification in an Online Grocery Store.

The overall objective of this research is to evaluate the impact of gamification on the diet quality of food choices made by American adults in an online grocery shopping experiment. Participants will shop for 12 food items from a grocery shopping list determined by the research team in a simulated online grocery store designed for this experiment. Each product has a nutritional quality score based on the Guiding Stars algorithm. The experiment tests the gamification of the nutritional quality score. Participants exposed to gamification see one to five crowns illustrating the nutritional quality of the food and a scoreboard indicating the total number of crowns from foods in the participant's shopping basket. Participants will be assigned to experimental conditions of gamification (game or no game) and a fictitious budget ($30 or $50). The investigators will test if the game and the budget affect the dietary quality of their final shopping baskets. The experiment is a 2x2 experimental design. The investigators hypothesize that the presence of gamification will change the dietary quality of participants' final shopping baskets. The investigators hypothesize that a higher budget will change the dietary quality of the final shopping basket. The investigators also hypothesize that the game and higher budget together will change the dietary quality of the final shopping basket.

Participants will be assigned to one of four experimental conditions:

1. Game=No and Budget = $30
2. Game=No and Budget = $50
3. Game=Yes and Budget = $30
4. Game=Yes and Budget = $50.

Variables:

1. Game: Indicates exposure to the game (dummy variable)
2. Budget: Indicates exposure low ($30) or high ($50) budget constraint (dummy variable).
3. Total number of crowns: sum of the number of crowns associated with the 12 items included in participants' final shopping baskets (a continuous variable that ranges from 12 to 60).
4. Number of crowns: number of crowns associated with each of the 12 items included in participants' final shopping baskets separately (a continuous variable that ranges from 1 to 5).

Eligibility Criteria:
The investigators will exclude from the analysis:

1. Participants who had more than or less than 12 items in their final shopping cart.
2. Participants who had four or more items from the same food subcategory in the final shopping basket.
3. Participants who spent more than 120% of the budget assigned to them.
4. Aged \< 18 years
5. Do not have access to a personal computer, laptop, tablet, or mobile phone.
6. Participants who were not in the US when participating in the study.

Inclusion criteria:

1. Participants who had 12 items in their final shopping cart.
2. Participants who had less than four items from the same food subcategory in their final shopping basket.
3. Participants who spent 120% or less of the budget assigned to them.
4. Aged 18 or older
5. Have access to a personal computer, laptop, tablet, or mobile phone.
6. Participants who were in the US when participating in the study.