cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Tolerability of Grazoprevir and Elbasvir in Patients With Chronic Genotype 1 HCV and HIV Co-infection

This clinical study will evaluate whether grazoprevir and elbasvir is efficacious, safe, and well-tolerated in peginterferon alfa plus ribavirin experienced patients who inject drugs (PWID) and men who sex with men (MSM) with genotype 1 HCV and HIV co-infection.

Primary Objective •To assess the efficacy of grazoprevir 100mg and elbasvir 50mg by determining the proportion of sustained virological response 12 weeks after the end of therapy (SVR12; HCV RNA concentration less than 10 IU/ mL at follow-up week 12) in peginterferon alfa plus ribavirin experienced patients with genotype 1 HCV and HIV co-infection, compared with treatment-naïve patients with 1 HCV and HIV co-infection.

Secondary Objective

•To assess the tolerability of grazoprevir 100mg and elbasvir 50mg in peginterferon alfa plus ribavirin experienced patients by measuring frequency of SAEs and AEs leading to discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* Men and non-pregnant women, at least 20 years of age with chronic genotype 1 HCV and HIV co-infection.
* HCV RNA \> 10,000 IU/mL
* Stable antiretroviral therapy (ARV) with confirmed plasma HIV-1 RNA \< 200 copies/mL
* CD4 T-cell count \> 100 cells/L
* peginterferon alfa plus ribavirin failure: null response \<1 log10 IU/mL reduction in HCV RNA at week 4; detectable HCV RNA since week 12 to the end of treatment; detectable HCV RNA for 12 to 24 weeks after the end of treatment; or discontinuation of peginterferon alfa plus ribavirin due to grade 3 or grade 4 adverse effects at any moment.

Exclusion Criteria:

* Decompensated liver disease (presence or history of ascites, oesophageal or gastric variceal bleeding, hepatic encephalopathy, or other signs of advanced liver diseases)
* Liver cirrhosis with Child-Pugh class B or C, or with a Child-Turcotte-Pugh score of more than 6 points and albumin below 3 g/dL or platelet count below 75,000/ μL
* History of malignant disease, or evidence of hepatocellular carcinoma
* ARV with protease inhibitor containing regimen HBsAg and HBV core antibody should be checked in all patients. HBsAg positive patients should be excluded from the study. HBV core antibody positive patients should be closely monitored for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Appropriate patient management should be instituted for HBV infection as clinically indicated.
Effect of Whole Body Vibration on Down Syndrome

A congenital condition known as Down syndrome is typified by an excess of genetic material from chromosome 21, making 47 chromosomes in total. Development of the body and brain may be impacted. About 1 in 700-1100 live births have the condition, and 1 in 700-1100 live births inherit it. Heart disease, hypotonia, ligament laxity, cerebral disabilities, thyroid abnormalities, and metabolic diseases are among the physical, cognitive, and metabolic changes that define it. Reduced performance, increased energy consumption, and altered gait patterns are frequently the results of motor disorders. This study intends to ascertain the effects of whole body vibrations (WBV), an activity that has been recommended for individuals with Down syndrome, on gait parameters and postural control in children with this condition.

Whole Body Vibration (WBV) and routine physical therapy (RPT) are given to Group A, whereas routine physical therapy is given to Group B as a control. Two sessions of 20 minutes each are given to both groups twice a week. Postural control and gait metrics are the outcomes that will be examined. The present investigation will be conducted over a two-month period and will be a randomized control experiment. Alkhidmat Hospital in Sargodha and Al-Ghafoor Hospital in Bhera will provide the data. 16 participants will participate in the trial; they will be randomly assigned to two equal groups. Children with DS, ages 5 to 12, of both sexes, will be eligible to participate in the study. The condition of improved comprehension of children older than five years was taken into consideration when determining the inclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Ages 5-12
* Both sexes are chosen
* Children with Down syndrome older than 5 who are more knowledgeable about the exercise to be done are given preference.

Exclusion Criteria:

* Children with cardiac conditions and other conditions
* Atlantoaxial instability and prosthesis implantation are excluded.
* DS kids who don't have their parents or legal guardians sign the consent form.
Blood and Tumor Tissue Samples From Young Patients With Acute Myeloid Leukemia

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying blood and tumor tissue samples from young patients with acute myeloid leukemia.

OBJECTIVES:

* To evaluate Mer and Axl expression in samples from pediatric patients with acute myeloid leukemia (AML).
* To determine if abnormal expression of Mer and Axl is associated with poor clinical characteristics (e.g., induction failure or relapse) of AML in these patients.

OUTLINE: This is a multicenter study.

Archived samples from pediatric patients with acute myeloid leukemia are analyzed for Mer and Axl expression by flow cytometry and western blot assays.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia
* Children Oncology Group (COG) patient samples

PATIENT CHARACTERISTICS:

* Available clinical data

PRIOR CONCURRENT THERAPY:

* Not specified
The Efficacy of Electrical Version of Patient Reported Outcome

Recently the importance of electrical PRO system is increased for the accuracy, convenience, and efficiency for both patients and physicians. For the evaluation of quality of life, various self-reported questionnaires is filled-out by the patient, mostly in front of outpatient clinic, and doctor usually take times to calculate the score. If there is electrical PRO which is available with mobile device, the efficacy of clinic would be improved. The investigators developed such a system and applied the system for patients with spinal disease. The investigators assessed the effectiveness of application of electrical-PRO in outpatients' clinic for patients who had filled-up same questionnaire in paper version.

Age, sex, education levels, use of smartphone, the number of applications.

Eligibility Criteria:
Inclusion Criteria:

* We assessed the effectiveness of application of electrical-PRO in outpatients' clinic for patients who had filled-up same questionnaire in paper version

Exclusion Criteria:

* Computer illiterate
* Uncooperative patient
Arthritis Foundation Exercise Program & "10 Keys" to Healthy Aging--Prevention Research Center

Older adults are at high risk for loss of independence because of age-related chronic health conditions. Of these chronic conditions, arthritis accounts for the largest proportion of the disability in the community. The investigators propose to target older adults who have self-reported arthritis or joint pain for dissemination of a disability prevention program. The program will be a collaborative effort of the Arthritis Foundation, the investigators Prevention Research Center staff and other key partners in the community. The project will develop information needed to provide guidance for implementation of the investigators intervention by other agencies and organizations. As a major thrust of the investigators CDC Prevention Research Center, the investigators have developed a comprehensive program focused on preventing disease and disability in older adults: the "10 Keys to Healthy Aging". Each of the 10 Keys disseminates proven approaches and current recommendations for prevention in older adults, focusing on age 65+ but also addressing age 50-65 years. The overall objective is to determine if an integrated evidence based exercise intervention (AFEP) combined with health education on preventive practices for older adults ("10 Keys") is more effective for improving mobility and risk factors for mobility disability and use of preventive services compared to exercise alone (AFEP). The investigators will also propose to evaluate the impact of geographic location on outcomes and overall sustainability of the program.


Eligibility Criteria:
Inclusion Criteria:

* 50+ years old
* Attends at last one exercise class in a 10 week program

Exclusion Criteria:

* On oxygen
* Hospitalized for cardiac event in past 6 months (at least 1 overnight)
* Had major surgery in past 6 months
A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis

This Phase 3 study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day as monotherapy in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 Rheumatoid Arthritis studies.


Eligibility Criteria:
Inclusion Criteria:

* The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
* The patient has active disease at both Screening and Baseline, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) \>28 mm in the local laboratory. 2. CRP \>7 mg/L in the central laboratory
* Patient had an inadequate response to at least one DMARD (traditional or biologic) due to lack of efficacy or toxicity.
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
* Patient has washed out of all DMARDs other that antimalarials

Exclusion Criteria:

* Blood dyscrasias including confirmed: 1. Hemoglobin \<9 g/dL or Hematocrit \<30%; 2. White blood cell count \<3.0 x 109/L; 3. Absolute neutrophil count \<1.2 x 109/L; 4. Platelet count \<100 x 109/L
* History of any other autoimmune rheumatic disease other than Sjogren's syndrome
* No malignancy or history of malignancy.
* History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias

This is an open-label, continuous daily dosing, two-part safety and efficacy study of SKI-606 (bosutinib) in Philadelphia chromosome positive leukemias (Ph+). Part 1 is a dose-escalation study in chronic phase Chronic Myelogenous Leukemia (CML) subjects to establish the maximum tolerated dose (MTD) in this subject population. Part 2 has begun after the completion of Part 1 and after a dose has been established for the compound in chronic phase subjects. Part 2 is a study of the the efficacy of 500mg daily oral SKI-606 (bosutinib) in patients with all phases of Ph+ CML and Ph+ Acute Lymphocytic Leukemia (ALL). The protocol will test the hypotheses that oral daily dosing of bosutinib at 500 mg will attain (1) Major Cytogenetic Response (MCyR) in chronic phase CML patients and (2) Overall Hematological Response (OHR) in advanced leukemia patients. Each phase of the disease will be evaluated as a separate cohort.


Eligibility Criteria:
Inclusion Criteria:

* Ph+ CML or Ph+ ALL who are primarily refractory to full-dose imatinib (600 mg), have disease progression/relapse while on full-dose imatinib, or are intolerant of any dose of imatinib.
* At least 3 months post stem cell transplantation
* Able to take daily oral capsules/tablets reliably

Exclusion Criteria:

* Subjects with Philadelphia chromosome, and bcr-abl negative CML
* Overt leptomeningeal leukemia
* Subjects without evidence of leukemia in bone marrow (extramedullary disease only)
Serum and Peritoneal CEA and CA 19-9 for Gastric Adenocarcinoma

For preoperative staging and prediction of peritoneal dissemination of gastric adenocarcinoma, usage of serum and peritoneal levels of carcinoembryonic antigen (CEA) and CA 19-9 may be helpful. Additionally, the prognosis of the patients with gastric adenocarcinoma treated with gastrectrectomy may be associated with serum and peritoneal levels of tumor markers.

Clinical usage of tumor markers on preoperative staging and prediction of peritoneal dissemination of gastric adenocarcinoma is a controversial issue. It has been thought that there is a positive correlation between serum and peritoneal levels of carcinoembryonic antigen (CEA) and CA 19-9 and pathologic features of gastric tumors and peritoneal dissemination.

In this study, it was aimed to evaluate the effect of serum and peritoneal CEA and CA 19-9 to predict TNM stages and peritoneal washing cytology in patients with gastric adenocarcinoma after curative gastrectomy, and to determine predictive value of these measurements to the development of recurrence and death.

Eligibility Criteria:
Inclusion Criteria:

* Endoscopically proven gastric adenocarcinoma
* Standard gastrectomy and a D2 lymph node dissection;
* Desire to attend the study protocol

Exclusion Criteria:

* Metastatic or overt peritoneal disseminated cancer
* Undesired reaction to attend the study protocol
Comparison Between Prepectoral and Subpectoral Breast Reconstruction

There are controversies about breast implant-based reconstruction techniques. Our center pioneered single-port insufflation endoscopic nipple-sparing mastectomy (SIE-NSM) combined with stage I prosthesis reconstruction. The study's primary objective is to compare single-port endoscopic NSM combined with pre-pectoral breast reconstruction to the subpectoral breast reconstruction group regarding breast satisfaction.

This study is an ambispective cohort study. The study will be conducted at Beijing Friendship Hospital, affiliated with Capital Medical University. Patients will be enrolled retrospectively from January 2014 to March 2022 by reviewing the medical records and recruited prospectively from March 2022 to March 2025. The two cohorts are the pre-pectoral breast reconstruction cohort and the subpectoral breast reconstruction cohort, both following single-port insufflation endoscopic nipple-sparing mastectomy. The primary outcome of this study is postoperative breast satisfaction, which the BREAST-Q score will measure. The different variables will be compared using the Χ2 test for categorical variables and the Mann-Whitney test for continuous variables.

Sample size and statistical analysis This study is an ambispective cohort study. According to the previous retrospective research data of the center, the breast satisfaction score is the main research object. The standard deviation was 2.6, the non-inferiority margin was 0.15, the test level was α=0.05, β=0.2, and a one-sided test was performed. Eighty patients will be needed for two cohorts in a 1:1 ratio. Considering the 10% loss to follow-up rate, 44 patients will be required to be enrolled in each group.

Eligibility Criteria:
Inclusion Criteria:

1. Female patients with preoperative pathologically confirmed early-stage invasive breast cancer (stage I or stage II) by core needle biopsy.
2. Breast-conserving surgery is not possible due to the presence of contraindications to breast-conserving surgery, or the patient actively requests total mastectomy.
3. Patients having willingness for breast reconstruction.
4. Age between 18 to 70 years.
5. Maximum diameter of the cancer lesion ≤ 3 cm.
6. Physical examination and breast magnetic resonance imaging (MRI) confirmed that the tumor did not invade the skin, subcutaneous tissue, or chest wall.
7. The distance between the lesion and the nipple is ≥2 cm, and it is confirmed by physical examination and MRI that the nipple-areola complex is not invaded.
8. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale of 0 to 2.

Exclusion Criteria:

1. patients having serious medical diseases, including unstable angina pectoris, myocardial infarction, and cerebrovascular accident within 6 months.
2. Having history of malignant tumor (s) within 5 years.
3. Patients under immunosuppressive therapy for organ transplantation.
4. Having continuous systemic steroid hormone therapy.
5. Pregnant or lactating women.
Impact of Patient Education on Influenza Vaccine Uptake Among Community-dwelling Chinese Elderly

The purpose of this study is to test the effectiveness of brief face-to-face patient education in increasing uptake of influenza vaccine among Chinese elderly in the community.


Eligibility Criteria:
Inclusion Criteria:

* Cantonese speaking
* Chinese

Exclusion Criteria:

* cognitively impaired
* unable to communicate effectively
* having known contraindication of vaccination
* institutionalized
Delivery of Nutritional Services in Nicaragua

This study investigates nutritional status, at predefined points in therapy, and the association with outcomes in children and adolescents undergoing treatment for cancer in institutions under Asociación de Hemato-Oncología Pediátrica de Centro América (AHOPCA) consortium in Central America. The aim of the study is to examine the effects of the newly-established nutritional program aimed at improving the delivery of nutritional care and outcomes in children undergoing treatment for cancer in Central America.

In low and middle-income countries, children with cancer are simultaneously dealing with malnutrition in high proportions. Without proper access to care and a minimal or basic level of care, these children are exposed to worse conditions. Studies have shown that more than half of the children with cancer are also malnourished at diagnosis. This increases children's risk of complications associated with the treatment as well as the abandonment of care, as well as decrease the level of survival rates. With an established nutritional education and clinical intervention program, the outcomes of these children can be improved, especially in Central America where the cancer rates and malnutrition is high, as shown by several studies.

Eligibility Criteria:
Inclusion Criteria:

* Recent diagnosis of childhood cancer (Solid Tumors)
* Recruited at diagnosis
* Under the age of 18 years

Exclusion Criteria:

* Other cancer diagnosis
* Palliative care patients
Novel Pulmonary Function Measures for Diagnosis of Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem-Cell Transplantation in Children

In this study, we will study 129Xe-MRI and LCI as tools for diagnosis of BOS in pediatric patients who have received Hematopoietic Stem Cell Transplantation (HSCT) and have been identified as eligible for this study. Participants will be required to have vital signs collected, complete breathing tests and complete an MRI. The MRI will require participants to perform breath holds in the MRI scanner with xenon gas while being coached by a research assistant.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants aged 6 -17.9 years old.
* Received HSCT treatment at least 6 months prior to enrollment in study.
* Participants should have an FEV1%pred value greater than 40%.
* Participant understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent or assent.
* Participant must be able to perform a breath hold for 16s.
* Participant meets MRI screening criteria

Exclusion Criteria:

* Participant has had a cold or respiratory infection in the last four weeks.
* Participant requires supplemental oxygen or has a daytime room air oxygen saturation ≤ 95%.
* Participant is unable to perform spirometry or plethysmography maneuvers.
* Participant is pregnant or lactating.
Cost of Care for Juvenile Idiopathic Arthritis

This project seeks to collect data on healthcare utilization and expenditure rates in Juvenile Idiopathic Arthritis (JIA) patients from across the US, correlate these costs with disease activity and outcome measures and determine methods by which to reduce the economic impact while improving outcomes.

SPECIFIC AIMS AND OBJECTIVES

The specific aims of this registry protocol are:

* To create and maintain a secure online database of patients with JIA
* To collect data elements related to cost of care in patients with JIA
* Compare standard outcome and disease activity measures to health care expenditures in JIA
* To determine methods by which to reduce costs while improving outcomes and quality of care

The study plans to enroll 300 or more subjects from 3 medical centers in the US over a 24 month period. Subjects in the study are patients with Juvenile Idiopathic Arthritis.

Enrollment into the protocol will include key demographic and clinical data including, medication exposures, disease severity, and function including disease-specific data elements; and estimates of health care service utilization and health care expenditures. Data will be collected once per subject within the context of a standard of care visit.

Eligibility Criteria:
Inclusion Criteria:

* Subject has been diagnosed with JIA by a pediatric rheumatologist according to published criteria.
* Person providing consent must be able to read English.
* Subject (and/or parent/legal guardian) is able to provide informed consent and willing to comply with study procedures.

Exclusion Criteria:

* Subject/ legal guardian is unwilling to provide consent, cannot read English, or does not meet published criteria for JIA.
* Coexisting rheumatologic disorder
* Diagnosis of fibromyalgia
* Participation in a drug trial in the past 6 months.
Comparisons of 3-month Versus 6-month Solifenacin Treatment for Female OAB Patients

To investigate whether prolonged period of treatment (6 months) can have a better therapeutic outcome than conventional period (3 months) of antimuscarinics.

Overactive bladder syndrome (OAB), with or without urge incontinence, is characterized by urinary urgency, frequency and nocturia. Thus, patients with OAB could be considered to have a reduced quality of life. Patients with overactive bladder syndrome have a higher risk of falling and fracture due to nocturia. OAB affects around 17 % of female population. At present, muscarinic receptor antagonists are the ﬁrst-line pharmacotherapeutic agents for OAB. However, discontinuation of the treatment often results in symptom relapse. Until now, optimal duration of the treatment and durability of the efﬁcacy have not been determined. We plan to use urodynamic studies outcome to evaluate therapeutic effect, with the change of urinary nerve growth factor level. This study is a randomized prospective study, comparing female OAB patient after 3 months and 6 months of antimuscarinic treatment.

The purpose of this study is to investigate the difference of urodynamic effects, therapeutic effect and urinary urinary nerve growth factor level between OAB females after 3 months and 6 months antimuscarinic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Women who have overactive bladder syndrome

Exclusion Criteria:

* Women who are less than 20 year-old