cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects

This was a Phase 2/3, open-label, multicenter study to evaluate the pharmacokinetics (PK), efficacy, and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/RTV) with or without dasabuvir (DSV) and with or without ribavirin (RBV) in Hepatitis C virus (HCV) genotype 1 or 4 (GT1 or GT4)-infected pediatric participants of ≥ 3 to 17 years of age.

The study population for Part 1, the PK study, included GT1-infected participants who were noncirrhotic and treatment-naïve (TN). Part 2, the safety and efficacy study, included GT1 or GT4-infected participants who were TN or interferon (\[IFN\] or Pegylated-interferon alfa-2a or 2b \[pegIFN\] with or without RBV) treatment-experienced (TE) without cirrhosis or with compensated cirrhosis. In Part 1 and Part 2, the treatment regimen and duration were dependent on HCV GT, GT1 subtype, and cirrhosis status.

Eligibility Criteria:
Inclusion Criteria:

1. Positive anti-hepatitis C virus antibody (HCV Ab) and HCV ribonucleic acid (RNA) ≥ 1000 IU/mL at the time of screening
2. HCV genotype 1 for enrollment into Part 1 of the study and genotype 1 or 4 for enrollment into Part 2
3. Parent or legal guardian with the willingness and ability to provide written informed consent and participant willing and able to give assent, as appropriate for age and country

Exclusion Criteria:

1. Female participant who is pregnant, breastfeeding or is considering becoming pregnant
2. Use of known strong inducers and inhibitors (e.g., gemfibrozil) of cytochrome P450 2C8 (CYP2C8) in participants receiving dasabuvir, or strong or moderate inducers of CYP3A, within 2 weeks or 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration.
3. Positive test result for Hepatitis B surface antigen (HbsAg) or anti-human immunodeficiency virus antibody (HIV Ab) test
4. Current enrollment in another interventional clinical study, previous enrollment in this study, prior or current use of any investigational or commercially available anti-HCV agents other than interferons or ribavirin or receipt of any investigational product within 6 weeks prior to study drug administration
A Study of SPH3127 in the Treatment of Mild to Moderate Ulcerative Colitis

To preliminarily evaluate the clinical efficacy of the renin inhibitor SPH3127 Tablets in patients with mild to moderate ulcerative colitis with placebo as a control and determine the recommended dose.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 - 75 years, male or female;
2. Subjects who have been diagnosed with ulcerative colitis；
3. Subjects who agree to take effective contraceptive measures with their spouses throughout the study period and for up to 12 weeks after the last dose;
4. Subjects who thoroughly learn about the nature, significance, possible benefits, possible inconvenience and potential risks of the trial, understand the study procedures and voluntarily sign the informed consent form prior to their participation in the trial.

Exclusion Criteria:

1. Subjects who are diagnosed with Crohn's disease or indeterminate colitis;
2. Subjects with active infections at screening which may, as evaluated by the investigator, cause increased risks for subjects;
3. Subjects who had surgery that might impact the absorption of oral drugs, subjects who will undergo surgery during the study period, subjects who have undergone major surgery before screening, or subjects who have a plan of surgery during the study period;
4. Subjects and lactating women and those who will become pregnant within 6 months after the trial starts;
5. Subjects with a history of drug abuse with clinical significance within 1 year prior to screening;
6. Subjects with other diseases or conditions that the investigator considers unsuitable for this trial.
Pain, Discomfort, and Functional Impairments During Maxillary Expansion

Maxillary expansion is associated with varying degrees of pain and functional impairments. The current study aims to compare rapid maxillary expansion using a McNamara-type (bonded) appliance and slow maxillary expansion using a removable palatal expansion appliance concerning patient-centered outcomes. Those outcomes will include pain and discomfort, mastication difficulties, swallowing difficulties, and pressure on the soft tissues.

Skeletal maxillary constriction is one of the common orthodontic problems of all ages, which could be unilateral or bilateral. If it is neglected and not treated, it may result in later orthodontic problems such as skeletal deviation of the lower jaw. The current study aims to use two types of expanders to treat skeletal maxillary constriction in adolescents aged between 12 and 16 years. The study sample will include 52 patients who will be equally divided into two groups: the slow and the rapid maxillary expansion groups. Patients will be asked to answer a questionnaire within five assessment times during the expansion procedure. The questionnaire will contain four questions: 1) What is the degree of discomfort/pain? 2) What is the degree of mastication difficulties? 3) What is the degree of swallowing difficulties? 4) What is the degree of any sense of pressure in soft tissue?

Eligibility Criteria:
Inclusion Criteria:

1. Adolescents between 12 and 16 years.
2. Early permanent dentition.
3. Skeletal bilateral maxillary constriction.
4. There is no loss or absence of any permanent teeth except for the third molar.
5. Dental and skeletal class I/II malocclusion.
6. Normal/mild vertical growth pattern.

Exclusion Criteria:

1. Previous orthodontic treatment.
2. A severe horizontal growth pattern.
3. Any periodontal diseases.
4. Any general diseases or syndromes.
Study of Combination of PIGEV Before Autologous Stem Cell Transplant in Patients With Hodgkin's Lymphoma

study to assess maximum tolerated dose (MTD), safety, tolerability and activity of IGEV (Ifosfamide, Gemcitabine,Vinorelbine, Prednisolone) + Panobinostat new combination in order to determine the recommended phase II dose

Patients will received 4 p-IGEV courses repeated every 3 weeks in the absence of unacceptable toxicity, whenever an objective response is observed at disease evaluation performed after II cycle.

Eligible patients will be accrued in cohorts of 3 patients at each dose level and dose escalation will be performed following the standard 3+3 rule.

Three patients will be treated for each dose-level, starting from level 1, for one cycle: if no dose-limiting toxicities (DLTs) will be recorded after the first cycle, treatment will be continued in those patients until study completion or unacceptable toxicity and three new patients will be treated at the next dose level. However, if one out of 3 patients will develop a DLT, the same dose-level will be administered to three additional patients for one cycle. If no one of those additional patients will experience a DLT, dose escalation will continue. If more than one over 3 or 6 patients will develop a DLT after the first cycle in any cohort, MTD will be reached. Six further patients will be treated at the lower dose in order to obtain more information about the optimal dose for phase II trials and to characterize pharmacokinetic profiles of this combination. If DLT will be found at level 1 (20 mg), 3 patients will be treated at dose -1 (10 mg). If no more than 1 patient experience toxicity, other 3 patients will be treated to assess more information about pharmacokinetic profiles and safety.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of relapsed or refractory classical HL
* Measurable disease
* One or two prior systemic lines of treatment
* PS(ECOG) 0-2
* Absence of bone marrow infiltration
* Adequate laboratory values for bone marrow, liver and renal functionality

Exclusion Criteria:

* prior or concurrent treatment with a DAC inhibitor including panobinostat
* valproic acid therapy for any medical condition during the study or within 5 days prior to the first panobinostat treatment
* previous autologous hematopoietic stem cell transplant
* other concurrent therapy intended to treat the primary cancer including chemotherapy, investigational or biologic agents or other antitumor agents
* impaired cardiac function or unstable AF
* known history of HIV seropositivity, chronic hepatitis, or other active viral infections
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of panobinostat (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, obstruction, or stomach and/or small bowel resection)
* pregnant or breast feeding women
Hip Arthroplasty and Vitamin D Status

It is essential that serum 25(OH)D changes following surgery be clarified, and the mechanism(s) underpinning these changes be identified. As such, the overarching hypothesis of this study is that elective total hip arthroplasty reduces serum total 25(OH)D.


Eligibility Criteria:
Inclusion Criteria:

* Elective total hip arthroplasty for osteoarthritis
* Age 50+
* Able and willing to sign informed consent
* English speaking
* Willing to not alter vitamin D supplementation use for the duration of this study
* Willing to utilize sunscreen of SPF-15 or higher when sun exposure for more than 15 minutes is expected

Exclusion Criteria:

* Illnesses known to affect inflammatory marker status including, but not limited to, rheumatoid arthritis, systemic lupus erythematosis and mixed connective tissue disease
* Chronic diseases that could potentially affect DBP status, e.g., chronic kidney disease stage requiring dialysis, nephrotic syndrome and chronic hepatitis,
* Hip arthritis from causes other than osteoarthritis
* Treatment with medications with potential to affect vitamin D metabolism, (e.g., phenytoin, phenobarbital, teriparatide or active vitamin D analogues) or to potentially interfere with 25(OH)D measurement by HPLC (atavaquone) within the preceding three months.
* Treatment with high dose vitamin D supplementation (50,000 IU weekly or more frequently) within the preceding three months. Note; subjects on a stable daily vitamin D dose will be allowed to participate
* Surgical procedure within the preceding six months
* Use of tanning beds or salons or unwillingness to utilize sunscreen during periods of sun exposure of 15 minutes or longer
Lead Extract Study

The recent expansion of indications for implantable cardioverter defibrillators (ICDs) has changed the population of patients being implanted. Younger and healthier patients are now being implanted for primary prevention of sudden cardiac death. Due to the younger population, the likelihood of the lead failing during the lifetime of the patient is higher and also more likely to need extraction. To reduce the risk of the lead extraction procedure and therefore reduce the number of abandon leads, ICD lead manufacturers are designing leads to offer improved chronic extractability to reduce the morbidity and mortality during these procedures.

This study will enroll up to 100 subjects at our site only. Prior to the procedure information will be collected including the subjects demographics, medications, medical, cardiovascular and surgical history. During the lead extraction procedure specific data will be gathered which includes items such as: total lead length, lead length from insertion site to connector end of lead just prior to lead extraction, extraction tools used and the physician description of the extraction. The patients will undergo an assessment of extraction force up to 3 kilograms maximum to the ICD lead for a specified amount of time before the use of laser or extraction sheaths. Extraction forces and approximate times will be monitored and recorded throughout the procedure. Forces will be measured by using a force gauge. Xrays will be taken to show lead position during movement of the arm at the side, above the head and across the chest. Fluoroscopy images of the heart may be saved. The amount of extra time added to the case in order to perform this study and collect the data is estimated at 10 minutes. Participation in the study is complete following the procedure. There is a 30-day follow-up phone call to capture any adverse events which require a clinic visit, ER visit or hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 18 years of age or older,
* be scheduled for an ICD lead extraction and
* willing and able to sign the informed consent.

Exclusion Criteria:

* Patients with lead implant duration less than 6 months,
* patients with gross chronic lead infections,
* patients with epicardial or subcutaneous ICD systems (without transvenous ICD lead) and
* patients who are pregnant or suspect they may be pregnant.
An Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects

This is a double-blind, randomised, three period crossover phase 1 trial using automated 8-hour euglycemic clamps in healthy Japanese subjects.

Each subject will be randomly allocated to one out of nine sequences to receive either three single doses of BioChaperone insulin lispro or one single dose of Humalog® and two single doses of BioChaperone insulin lispro on three separate dosing visits.

The total trial maximum duration for a subject will be up to 10 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese male or female subjects by completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
* BMI between 18.5 and 25.0 kg∙m-2, both inclusive.
* Fasting Plasma Glucose ≤ 5.6 mmol/L (100 mg/dL).
* Signed and dated informed consent obtained before any trial-related activities.

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product(s) or related products.
* Receipt of any investigational medicinal product within 3 months before randomisation in this trial.
* Any history or presence of a life threatening disease (i.e. cancer except basal cell skin cancer or squamous cell skin cancer), or of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (including type 1 and type 2 diabetes mellitus, haematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the investigator.
* History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
Pattern of Autoimmune Hepatitis in Children In Sohag University Hospital

Autoimmune hepatitis (AIH) is a progressive inflammatory liver disorder of unknown etiology. If left untreated, it progresses to liver cirrhosis and liver failure.

Diagnosis of AIH relies on the exclusion of other causes of liver disease and the presence of positive clinical, biochemical, and histological criteria.

AIH has a very wide spectrum of clinical presentations ranging from being asymptomatic to an acute severe fulminant disease.

It may be associated with other autoimmune disorders such as thyroiditis, type 1 diabetes, vitiligo, inflammatory bowel disease, or juvenile idiopathic arthritis.

Biochemical features of AIH include elevation of serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and immunoglobulin G (IgG) in addition to autoantibodies.

Liver biopsy is recommended in any patient with suspected autoimmune hepatitis where interface hepatitis is the hallmark of the disease.

Immunosuppression is the mainstay of therapy in AIH. Prednisone is administered as the initial therapy either alone or in combination with azathioprine.

Liver transplantation is indicated in patients who develop fulminant hepatic failure that is unresponsive to corticosteroids and in patients who develop end-stage liver disease.


Eligibility Criteria:
Inclusion Criteria:

* Age: under 18 years old.
* Both sex.
* children suffering from manifestations of Autoimmune Hepatitis. Children previously Diagnosed with Autoimmune Hepatitis

Exclusion Criteria:

* Patient infected with hepatitis B or C.
* Patient had autoimmune hepatitis after liver transplantation.
* Patients not respond to steroids and immunosuppressive therapy. Other Causes of acute and chronich hepatitis like wilson disease and Metabolic liver Diseases
A Study of Workflow-Integrated Artificial Intelligence for RPM Enrollment

The objective of this study is to evaluate effectiveness, usability and clinical utility of the remote patient monitoring (RPM) "fit" score when choosing patients to enter the RPM Program.


Eligibility Criteria:
Inclusion Criteria:

* The study participants will be nurses who are part of the RPM care team that cares for adult patients ≥18 years.
* A patient's data will be included in the analysis if the patient is ≥18 years old and receives care from a participating nurse.
* Patient data will only be collected if permitted (based on the use of the Minnesota Research Authorization Retrieval Tool).
* Patients who will be considered for this study will be assessed based on standard RPM program inclusion and exclusion criteria for the any of the chronic disease RPM programs (congestive heart failure, coronary artery disease, hypertension, type 2 diabetes, COPD, and general complex care).

Exclusion Criteria:

- \< 18 years old.
Partial Breast Irradiation Using Non Invasive Approach for Early Stage Breast Cancer

The purpose of this study is to evaluate the rate of early and intermediate toxicity related to the AccuBoost System for delivery of APBI in women with resected, early stage breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. A confirmed histological diagnosis of invasive breast carcinoma or DCIS
2. Age greater or equal to 50 years old
3. Life expectancy \> 6 months
4. Treated by breast conserving surgery with axillary node dissection or sentinel lymph node biopsy
5. Pathologic tumor size less than or equal to 2 cm
6. Invasive ductal, mucinous, tubular or colloid histology
7. Estrogen receptor positive for invasive carcinoma.
8. Unifocal/unicentric disease
9. Negative surgical margins greater than or equal to 2 mm
10. Pathologic lymph node negative
11. No evidence of lymphovascular invasion
12. ECOG performance status of 0 or 1 (Appendix 1)
13. Informed consent signed.

Exclusion Criteria:

1. Known BRCA 1/2 Mutation; (BRCA 1 and 2 testing is not required)
2. Autoimmune disorder
3. Pregnancy
4. Breast implants
5. Psychiatric or addictive disorder that would preclude attending follow-up
6. Neoadjuvant chemotherapy (adjuvant chemotherapy is permitted)
7. Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign)
8. Lobular features on histology (pure or mixed) or sarcoma histology
9. Node positive on axillary dissection or in the sentinel lymph node biopsy;
10. Extensive in situ carcinoma (EIC)
11. Multicentric or multifocal disease
12. Paget's disease of the nipple
13. Distant metastases
14. Lumpectomy cavity not well visualized on AccuBoost imaging
15. Lumpectomy cavity with 1cm margin (PTV) not adequately encompassed by any applicator (PTV \> 6cm)
16. Breast separation with compression \> 7cm.
17. Overlap of skin between orthogonal treatment axes.
Calcium Channel Splice Variant Expression in Cardiovascular Disease and Aging

The purpose of this study is to learn what changes in blood vessel contraction may occur as a result of a disease of the vessel that requires surgery. The study will examine the calcium channels present in the vessels being operated on, and the genes that may alter blood vessel function. Possible variation in these genes may change the kind of calcium channels present in blood vessels.

The goal of this study is to learn more about how blood vessels function and the mechanism that causes them to contract. The study will investigate the natural history of diseased blood vessel tissue and the calcium channels in the muscle part of the blood vessel. The study will also examine how genetics influences cardiovascular disease and its causes and treatments.

Patients scheduled for vascular surgery will be approached to participate in this study. During surgery, tissue fragments of diseased and marginal tissue will be obtained. A blood sample will be obtained at either the time of surgery or consent and genomic DNA will be extracted.

Eligibility Criteria:
Inclusion Criteria:

* Ages 21 and older
* Scheduled for vascular surgery

Exclusion Criteria:

* Unwillingness to be subjected to diagnostic and/or therapeutic procedures that are deemed not necessary for clinical management
* Volunteers deemed too fragile to participate in the study by the principal investigator (PI) or the attending physician
* Inability to obtain informed consent from either the volunteer or the responsible party (durable power of attorney \[DPA\]) for the volunteer, with the volunteer's assent
Evaluation of 68-GaNOTA-Anti-HER2 VHH1 Uptake in Brain Metastasis of Cancer Patients

This study investigates the uptake of the radiopharmaceutical 68-GaNOTA-Anti-HER2 VHH1 in brain metastasis using PET/CT imaging. Patients with HER2-positive and HER2-negative cancer will be included and the uptake in their lesions will be compared.

Optional 68-GaNOTA-Anti-HER2 VHH1 scans may be performed during or after treatment, at time points 12±6 weeks and 24±9 weeks after the first scan.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have given informed consent
* Age 18 years or older
* Patients with brain metastasized cancer, with at least 1 brain lesion of at least 8 mm maximal diameter, as measured by CT or MRI.
* Patients with potentially HER2-positive cancer. Either a HER2 staining should have been done in standard of care, or sufficient tissue should be available for HER2-staining for study purpose.

Exclusion Criteria:

* Pregnant patients
* Breast feeding patients
* Patients with recent (\< 1 week) gastrointestinal disorders with diarrhea as major symptom
* Patients with any serious active infection
* Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the test radiopharmaceutical
* Patients who cannot communicate reliably with the investigator
* Patients at increased risk of death from a pre-existing concurrent illness
Services to Enhance Social Functioning in Adults With Autism Spectrum Disorders

The purpose of this study is to test a novel, three-part cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder.

The treatment, named TUNE In (Training to Understand and Navigate Emotions and Interactions), includes components to address the many behavioral domains involved in social functioning, including social motivation, social anxiety, social cognition, social skills, and generalization of the skills to community settings.

The Investigators will test the efficacy of TUNE In to improve social functioning in adults with autism spectrum disorder (ASD), using a randomized controlled trial using the SRS-2 as the primary outcome measure.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of autism spectrum disorder

Exclusion Criteria:

* intellectual disability
* severe mood or psychotic symptoms experienced in the past 4 weeks
* severe self-injurious or aggressive behavior
* severe extrapyramidal motor or sedating side effects of medications
* concomitant participation in another social skills treatment program.