cyrilzakka/clinical-trials huggingface dataset:
Distribution of Biospecimens From Biorepositories/Biobanks for Research Use

This protocol seeks to assist biorepositories/biobanks in distributing their stored specimens and data to researchers that will actually utilize them to advance medicine and technology.

iSpecimen has built a partner network comprised of supplying institutions that have ethically acquired human biospecimens and created biorepositories/biobanks to store the specimens and data.

Many of these biorepositories have protocols allowing for the collection of their samples but require an additional IRB or ethics review for the distribution of their samples.

This protocol establishes a method of such supply sites to allow their specimens to be distributed and used for research via iSpecimen's technology and network of research clients.

Eligibility Criteria:
Inclusion Criteria:

* Specimens and/or data from Biorepositories that have enrolled subjects that have provided consent for the specimens and de-identified data to be collected, stored and distributed.
* Specimens from biobanks that have collected materials and de-identified data under a waiver of consent
* Specimens from a biobank that meet the criteria for non human subject research under the common rule.

Exclusion Criteria:

* Specimens and/or that have been obtained from subjects without informed consent, nor waiver of consent or that do not meet the criteria for non human subject research under the common rule.
Validity and Reliability of Tele-Assessment Based Core Performance and Functional Capacity Tests in Healthy Individuals

The COVID-19 pandemic process has created the need for social isolation and quarantine, and restrictions have occurred in access to healthcare services. In this process, the trend towards alternative methods that will provide access to health services and the need for telehealth services has increased. As a result of this, when we look at the literature, evaluation methods used in the clinical environment in physiotherapy are frequently encountered in tele-evaluation. There is a need for validity and reliability studies of these evaluation methods in terms of tele-assessment. This study was designed to determine the validity and reliability of trunk endurance and functional capacity tests applied by the tele-assessment method in healthy individuals.

Tele-health has become a service whose prevalence has increased in recent years with the development of technology. Tele-health facilitates the accessibility of health services for individuals in all segments of society. Telerehabilitation, a subcomponent of telehealth, provides easy access to rehabilitation services by reducing cost, time, and distance barriers in physiotherapy. It offers physiotherapists the opportunity to observe the musculoskeletal system through physical assessment, exercise program planning, distance education, and continuous feedback of individuals. In this sense, tele-assessment has an important place within the scope of health services. As a result of the restrictions that came with the COVID-19 process, it has become difficult for individuals to access health services. With the effective use of technology to eliminate this obstacle, telehealth has become an alternative method. Tests such as curl-up, push-up, plank, and lateral bridge are frequently used to evaluate trunk endurance in healthy individuals. For functional evaluation, the timed sit and test, the timed stand up and test, the functional anterior reach test and the one-foot balance test are among the most used tests in the literature. The validity and reliability of these methods used in the face-to-face evaluation should be determined for the correct and effective tele-assessment.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years
* Does not have any diagnosed disease
* Volunteer
* Able to use the technology required for tele-assessment

Exclusion Criteria:

* Do not have the technology required for evaluations
* Not willing to participate in the study
* Who have a balance problem
A Two-way Crossover Study Of The Effect Of Food On The Pharmacokinetics Of Pazopanib In Cancer Patients

This is two-part study (Part I/Part II). Part I is designed to determine the effect of a low and high fat meal on the pharmacokinetics of single dose pazopanib (GW572016). Part II is designed to allow patients continued access to study drug in a multiple dosing regimen. Patients who are receiving clinical benefit on that regimen will go into the long term rollover study VEG105430 provided they are stable for 8 weeks.


Eligibility Criteria:
Inclusion criteria:

* Histologically or cytologically confirmed diagnosis of advanced solid tumors that have progressed following treatment with standard agents. Patients may have either measurable disease by RECIST or may be followed by a tumor marker for assessment of disease.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* Adequate bone marrow function: ANC greater than or equal to 1,500 mm cubed; Platelets count greater than or equal to 100,000 mm cubed; Hgb greater than or equal to 9 g per dL
* Adequate renal function as determined by a creatinine clearance greater than 50mL per min calculated by the Cockcroft-Gault Formula; Measured creatinine clearance greater than or equal to 50mL per min by 24-hour urine collection will be acceptable in lieu of a calculated value.
* Urine Creatinine Ratio of less than 1 as assessed in a random or spot urine sample.
* Adequate hepatic function: total bilirubin less than or equal to 1.5 times the upper limit of normal; AST and ALT less than or equal to 2.5 times the upper limit of normal.
* PT, INR, PTT less than or equal to 1.2 times upper limit of normal.
* Male or female at least 18 years of age.
* A woman is eligible to enter and participate in the study if she is of: Non-childbearing potential; Childbearing potential, has a negative serum pregnancy test at screening, and agrees to use adequate contraception per protocol. A man with a female partner of childbearing potential is eligible to enter and participate in the study if he uses a barrier method of contraception or abstinence during the study. If sexually active, patients will continue the recommended contraceptive measures for the duration of the treatment and for 28 days following discontinuation of therapy.
* Predicted life expectancy of at least 12 weeks.
* Written informed consent.
* Able to swallow and retain oral medications.

Exclusion criteria:

* Patients with certain heart problems or history of bleeding within a month.
Study of Anlotinib Combined With Docetaxel in Non-Driver Mutation Non-squamous NSCLC: the Save Study

The purpose of this study is to evaluate the Effectiveness and Safety of Anlotinib combined with Docetaxel in Progress after First line Standard Cheomotherapy in advanced non-driver mutation non- squamous non-small cell lung cancer

The purpose of this study is to evaluate the Effectiveness and Safety of Anlotinib combined with Docetaxel in Progress after First line Standard Cheomotherapy in advanced non-driver mutation non- squamous non-small cell lung cancer .According to the result of TAX317,the ORR of second line standard chemotherapy was 5- 8%. We expect the ORR was 20%. Using PASS11, we calculated the sample size of this study was 39 , according to 10% censoring,the expected sample size is 43.

Eligibility Criteria:
Inclusion Criteria:

* 18，Pathologically proven Non squamous non small cell lung cancer

  * No-drive gene mutaion (EGFR、ALK、ROS1） by NGS
  * Progress after second line
  * PS score 0-2

Exclusion Criteria:

* Patients received second line treatment
* Patients received treatment of Anlotinib or Docetaxel
* Patients with contraindication of chemotherapy
* Pregnant or breast feeding women
Dorsal Scapular Nerve Injection Combined With Muscle Needle Release

Ultrasound-guided perineural injection (PIT) of 5% dextrose (D5W) hydrodissection has been widely used in the treatment of peripheral entrapment neuropathies. However, there are few studies investigating the efficacy of PIT using D5W HD for dorsal scapular nerve (DSN) entrapment. Generally, the DSN entrapment causes the stiffness of the major and minor rhomboideus(2). In clinical practice, the investigators observed that ultrasound-guided PIT using D5W HD combined with needle release of major and minor rhomboideus significantly relieved the pain of scapular region. Therefore, the investigators aimed to evaluate the 6-month efficacy of this procedure for the participants with DSN entrapment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with DSN entrapment confirmed by electrophysiological study;
* age 18-80 years;
* patients who were irresponsive to conservative treatment;
* symptoms persisted for more than 3 months.

Exclusion Criteria:

* pregnancy
* DSN entrapment caused by trauma, surgery or occupying lesions of DSN;
* concurrent presence of rheumatic immune diseases, hypothyroidism, or diabetes mellitus;
* C5/6 lumbar radiculopathy;
* previous history of local injection or surgery for DSN entrapment.
A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia

This is a nonrandomized study of ruxolitinib in combination with a standard multi-agent chemotherapy regimen for the treatment of B-cell acute lymphoblastic leukemia. Part 1 of the study will optimize the dose of study drug (ruxolitinib) in combination with the chemotherapy regimen. Part 2 will evaluate the efficacy of combination chemotherapy and ruxolitinib at the recommended dose determined in Part 1.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for study when participant is 1 year to 21 years at the time of diagnosis
* Eligible Ages in Canada; 2 years to 21 years
* De novo high-risk (HR) Ph-like B-ALL for which any of following criteria are present at diagnosis:

  * Age ≥ 10 years
  * White blood cell (WBC) ≥ 50 × 10\^3/μL
  * CNS3 leukemia at diagnosis
  * Systemic steroid pretreatment without presteroid WBC documentation
* Diagnostic bone marrow or peripheral blood sample must have gene expression profiling and downstream genetic testing performed by submitting diagnostic specimens under the COG AALL08B1 or APEC14B1 biology studies, or AALL1131 or its successor study. Specimens must demonstrate a Ph-like expression profile (ie, LDA-positive) as tested by low density microarray testing at the COG ALL reference laboratory or TriCore laboratory at the University of New Mexico AND must contain 1 of the following genetic lesions: (determined at COG ALL reference laboratories, or equivalent CAP/CLIA-certified laboratories approved by the medical monitor:

  1. CRLF2 rearrangement with confirmed JAK1 or JAK2 mutation (JAK+)
  2. CRLF2 rearrangement without JAK mutation
  3. Other JAK pathway alterations (eg, JAK2 fusions, EPOR fusions, SH2B3 deletions, IL7RA mutations) with or without CRLF2-R, or CRLF2-R with unknown JAK status as determined by a COG ALL Reference Laboratory
* Completed a 4-drug Induction therapy regimen (modified aBFM regimen or equivalent) in Study AALL1131 or its successor study, or as per the institutional standard of care for HR B-ALL and have had end-Induction minimal residual disease (MRD) assessed
* Male and female subjects of reproductive non childbearing potential or willing to take appropriate precautions to avoid pregnancy or fathering a child for the duration of study participation

Exclusion Criteria:

* Receipt of any other cytotoxic chemotherapy before Induction therapy, with exception of hydroxyurea or steroid pretreatment
* Trisomy 21 (Down syndrome)
* BCR-ABL1-rearranged (Ph+) ALL
* Calculated creatinine clearance or radioisotope glomerular filtration rate \< 70 mL/min/1.73 m\^2
* Alanine aminotransferase ≥ 5 × upper limit of normal (ULN) for age
* Direct bilirubin ≥ 1.5 × ULN (may be assumed if total bilirubin is below ULN)
* History or evidence of cirrhosis
* Platelet count \< 75 × 10\^3/μL
* Absolute neutrophil count (ANC) \< 750/μL
* Positive screen for hepatitis B or C
* Known human immunodeficiency virus infection
Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study)

The purpose of the study is to determine whether the combination of Daclatasvir (DCV), Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C virus.

Allocation:

Initial Therapy: Randomized Controlled Trial: Participants are assigned to intervention groups by chance

Rescue Therapy: Nonrandomized Trial: Participants are expressly assigned to intervention groups through a non-random method such as physician choice

Number of Arms:

Initial Therapy: 2 Groups

Rescue Therapy: 2 Groups

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Males and Females ≥18 years of age, inclusive
* Chronic HCV infection Genotype 1 only
* Non-cirrhotic
* Treatment naive subjects with no previous exposure to an Interferon formulation (ie, IFNα, pegIFNα), ribavirin (RBV) or HCV Direct Acting Antiviral (DAA) (protease, polymerase inhibitor, etc.)

Exclusion Criteria:

* HCV Genotype other than Genotype 1
* Documented or suspected hepatocellular carcinoma
* Evidence of decompensated liver disease
* Contraindication(s) to Peg/RBV therapy
Aerobic Exercise on Fitness Score and Blood Glucose Level in Adolescents Girls With Diabetes Mellitus

In adolescent diabetic girls, a correct life style, including diet and physical activity, is part of a correct intervention protocol. Thus, the aim of this study was to evaluate the effects of aerobic training intervention, based on heart rate at glycemic level , on clinical and physiological parameters in adolescent girls with type 1 diabetes forty type1 DM girls will randomly assigned to an intervention (study group ) or control group. The study group will perform a supervised aerobic exercise training based on heart rate whereas control group maintained their usual lifestyle. Anthropometric fitness score measures, blood analysis will assess at baseline and after intervention.

fourty adolescents girls were diagnosed by physician as having type 1 diabetes mellitus and recruited from outpatient internal of El-Hussien hospital in Egypt . girls ages were between 13 and 18yr old; . The following inclusion criteria was applied to all participants in the study : all girls had type 1DM for more than 3 years, Their dose of insulin intake over 0.4 U/Kg/day, Body mass index (BMI) between 25 and 30 kg/m2 . Moderate-intensity aerobic exercise was defined according to the classification standard of the ACSM, which refers to exercise where the HRR of subjects is 64-76%; the moderate-intensity target heart rate area was set in advance and controlled by heart rate monitor during the intervention, and the menarche was began from 3 to 5 years. The patients had no history of severe and frequent hypoglycemia in the last 6 months (\< 60 mg/dl, more than twice a week).

All participants attended a clinic for clinical assessments before and after treatment plane.

1. Body Mass Index (BMI)
2. Fitness score
3. Target Heart Rate
4. Fasting blood samples, post prandial and HbA1c: were taken for the following measurements: glucose.
5. Estradiol blood test

Eligibility Criteria:
Inclusion Criteria:

* All girls had type 1DM for more than 3 years,
* Their didn't of insulin intake over 0.4 U/Kg/day, Body mass index (BMI) between 25 and 30 kg/m2

Exclusion Criteria:

* Diabetes as a secondary condition
* Any known cardiac defects and Macrovascular or microvascular chronical complications.
* Insulin therapy and regulate dietary intake Were followed through diabetes physician.
Mycetoma Retrospective Data Collection

The goal of this retrospective observational study is to describe mycetoma cases detected in health care facilities in India and Senegal in a 10-year period. The main objectives are to:

* Determine the number of mycetoma cases diagnosed per year and trends over time.
* Describe characteristics of diagnosed mycetoma cases.

  1. Describe demographic characteristics of patients with mycetoma.
  2. Describe clinical characteristics of patients with mycetoma upon initial presentation and over time.
* Assess etiology of mycetoma cases.
* Characterize clinical management of mycetoma cases.

  1. Characterize approaches to diagnosis of mycetoma.
  2. Investigate types and durations of treatments (including medical and surgical approaches) utilized to treat mycetoma cases.
  3. Describe clinical outcomes among patients with mycetoma.

The study team will review all available medical, laboratory and radiologic records of identified mycetoma cases and use data collection forms to extract relevant data.

Mycetoma is a poorly understood neglected tropical disease which disproportionately affects the poorest of the poor and is associated with substantial morbidity. The disease presents a multitude of diagnostic and management challenges; in particular, effective treatments for eumycetoma, the fungal and least understood form of the disease are lacking. DNDi and partners aim to conduct late-phase clinical trials on a promising new pharmacologic treatment for eumycetoma, but substantial knowledge gaps preclude such trials. These knowledge gaps include data on the burden, distribution, causative agents, clinical presentation, natural history, and common approaches to diagnosis and treatment of mycetoma in endemic countries.

This study, a retrospective review of mycetoma cases, aims to generate such data from several countries suggested by preliminary data to potentially be good candidate clinical trial sites.

Eligibility Criteria:
Inclusion Criteria:

* Any patient given a diagnosis of mycetoma in a medical, radiologic, or laboratory record.

Exclusion Criteria:

* Patients with illegible or inaccessible health records.
A Phase II Clinical Trial to Evaluate HLX208 in Advanced Non-small Cell Lung Cancer Patients With BRAF V600 Mutation

Evaluate the efficacy，safety and pharmacokinetics of HLX208 in advanced non-small cell lung cancer patients with BRAF V600 mutation


Eligibility Criteria:
Inclusion Criteria:

* Age\>=18Y
* Good Organ Function
* Expected survival time ≥ 3 months
* advanced BRAF V600 NSCLC that have been diagnosed histologically or cytology and have failed standard treatment or unable to receive, or refusing standard care.
* Previous failure to standard treatment, or insuitability for standard treatment or refuse standard treatment.
* ECOG score 0-2;
* Exclusion Criteria:
* Previous treatment with BRAF inhibitors or MEK inhibitors
* Presence of EGFR mutations or ALK rearrangements (unless disease progression following prior treatment with tyrosine kinase inhibitors).
* Symptomatic brain or meningeal metastases (unless the patient has been on \> treatment for 1 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
* Current or former patients with interstitial lung disease;
* Severe active infections requiring systemic anti-infective therapy
* A history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, adenocarcinoma in situ of the lung, or tumors that do not require interventional treatment after radical surgery.
* Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.
Evaluation of IL-6 in Synovial Fluid in Obese and Normal Weight Patients Suffering From Gonarthrosis During PTA

Evaluate the concentration of IL-6 in the synovial fluid of obese patients suffering from gonarthrosis during knee arthroplasty surgery


Eligibility Criteria:
Inclusion Criteria:

* age between 55 and 85 years inclusive,
* Normal weight patients with BMI 18-24.9 included
* Obese patients with BMI ≥ 30
* Patients suffering from gonarthrosis awaiting knee arthroplasty surgery
* Patients awaiting knee replacement surgery
* Patients who agree to sign informed consent

Exclusion Criteria:

* Patients under 55 years of age.
* Patients over 85 years of age
* Patients suffering from diabetes mellitus
* Patients who are unable to understand
* Patients with severe neurological disorders or severe disability
* Rheumatoid arthritis patients
* Cancer patients
* Patients on immunosuppressive therapy
A Multicenter Trial of Localized Radiation Therapy to Inhibit Restenosis (GAMMA V)

The objectives of this study are:

1. To show a reduction in the late thrombosis (LT) rate following percutaneous revascularization using current interventional techniques with new stent placement and intravascular radiation therapy (IRT) with a long-term antiplatelet regimen (12 months) compared to the stented patients on short-term antiplatelet regimen (2 months) from the IRT arm of GAMMA I Trial.
2. To show equivalence in the LT rate following percutaneous revascularization using current interventional techniques without new stent placement and IRT with a long-term antiplatelet regimen (6 months) compared to non-stented patients on short term antiplatelet therapy (2 months or less) from a pooling of the IRT arms of the GAMMA I, SCRIPPS, and WRIST Trials.


Eligibility Criteria:
Inclusion Criteria:

1. The patient has a restenosis of \>60% (by subjective angiographic determination of the minimal luminal diameter compared to the distal reference diameter) within a native coronary artery which has previously undergone stent placement.
2. The patient has a history, signs of, or laboratory studies that suggest coronary ischemia attributable to the target stenosis.
3. The study target lesion must be located in a restenotic native coronary artery measuring \>2.75 and \<4.0 mm in diameter and 45 mm in length. The target lesion must have undergone coronary interventional treatment \>4 weeks previously.
4. The vessel 1 cm distal to the target lesion is \>2.5 mm in diameter.

5 Patients age must be \>18 years and \<85 years.

Exclusion Criteria:

1. Attempts to treat lesions in other vessels during the procedure were unsuccessful.
2. The patient sustained a recent (\<72 hours) myocardial infarction defined as a serum CK 2x the upper limit of normal and elevated MB.
3. Serum creatinine \>2.0 mg/dl.
4. The left ventricular ejection fraction is \<40%.