cyrilzakka/clinical-trials huggingface dataset:
CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

The purpose of the study is to evaluate the safety and tolerability of the study drug, calaspargase pegol, when given with multi-agent chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed Philadelphia negative B- or T-cell acute lymphoblastic leukemia, with \>10% peripheral blood or bone marrow lymphoblasts at diagnosis.
* Treatment and full recovery from arm 1A of the Hyper-CVAD regimen.
* Be willing and able to provide written informed consent/assent for the trial.
* Able to adhere to the study visit schedule and other protocol requirements.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Cardiac ejection fraction ≥ 50% by echocardiography or MUGA, as measured prior to arm 1A of Hyper-CVAD.
* Serum bilirubin and creatinine \< 1.5x upper limit of normal (ULN). AST and ALT must be \<3x ULN.
* Females of childbearing potential (FCBP) must have a negative serum pregnancy test at screening. A FCBP is considered when a sexually mature female: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months.
* A FCBP must agree to use of two methods of highly effective non-hormonal contraception, be surgically sterile, or abstain from heterosexual activity for the course of the study through 3 monthsafter the last dose of study treatment.
* Male subjects must agree to use an adequate method of contraception starting with the first dose of study therapy through 30 days after the last dose of study therapy. Men must agree to not donate sperm during and after the study for 3 months

Exclusion Criteria:

* Induction therapy with any regimen other than Hyper-CVAD 1A.
* Diagnosis of L3 type Burkitt's lymphoma
* Clinical evidence of active central nervous system (CNS) leukemia.
* Any major surgery or radiation therapy within four weeks.
* Diagnosis of Down Syndrome.
* Any active infection requiring systemic therapy, including HIV, Hepatitis B, and/or Hepatitis C.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator (including but not limited to unstable angina, pre-existing liver disease, recurrent pancreatitis, uncontrolled diabetes, hypertriglyceridemia, pulmonary hypertension, or severeheart failure (New York Heart Association Class III-IV).
* Recurrent thrombosis, or non-central venous catheter associated thrombosis within 3 months prior to enrollment.
* Severe comorbid conditions for which life expectancy would be \<6 months.
* Patients with active (uncontrolled, metastatic) second malignancies are excluded.
* Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 3 months after the last dose of trial treatment.
Gut Microbiota Changes of HIV Patients Before and After One Year of ART

HIV infection leads to destruction of CD4+T cells in the gut-associated lymphoid tissue (GALT) and promotes a decline in mechanical barrier functions of the gut mucosa, and the subsequent translocation of microbial products from the gastrointestinal tract to systemic circulation. The gut mucosal immune system is not completely restored by cART, and the resultant microbial translocation may contribute to chronic inflammation, inadequate CD4 T-cell recovery, and increased rates of serious non-AIDS events. Many studies have revealed strong and characteristic compositional differences in gut microbiota between individuals with HIV infection and seronegative controls. So far, several probiotic organisms have shown the ability to enhance intestinal epithelial barrier functions, reduce inflammation, and support effective Th-1 responses. Probiotics mainly stimulates polymeric IgA secretion, avoid bacterial overgrowth and their translocation, and produce a self-limited inflammatory response through development of regulatory T (Treg) cells by anti-inflammatory cytokine production. Therefore, we design a prospective, randomized, double-blind, placebo-controlled study to determine whether the use of a probiotic can expand beneficial microbiota that aid in decreasing bacterial translocation and pro-inflammatory cytokine production, thereby improving immune functions in HIV-infected subjects. Participants in the intervention group will receive oral probiotic containing 3 billion Bifidobacterium and 1 billion Lactobacillus once daily, while those in the placebo group will take placebo which contains no probiotic but has the same flavor and characteristics as the probiotic product.. Gut bacterial community diversity and composition, immune recovery and activation in peripheral plasma, plasma levels of gut damage, microbial translocation and inflammation at baseline and after 12 months of receiving intervention will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old;
* Documented HIV infection;
* No history of gastrointestinal diseases;
* Good adherence and promise to follow-up;
* Ability to provide informed consent.

Exclusion Criteria:

* Administration of antibiotics, probiotics, or prebiotics or experience of diarrhea within the previous 3 months;
* Administration of anti-inflammatory drugs, corticosteroids, immunosuppressive drugs, immunomodulator within the previous 3 months;
* Severe organ dysfunction;
* Pregnancy or breastfeeding.
Retrospective Study of Reoperation After Primary Augmentation With NATRELLE® INSPIRA® Breast Implants

This study will evaluate the incidence of reoperations associated with the use of smooth and textured NATRELLE® INSPIRA® TruForm® 1 and TruForm® 2 devices in patients who have undergone primary breast augmentation.


Eligibility Criteria:
Inclusion Criteria:

* Primary breast augmentation (either bilateral or unilateral) operated on by the investigating surgeon with an infra-mammary approach smooth or textured NATRELLE® INSPIRA® TruForm® 1 or 2 device
* Primary breast augmentation 2 to 4 years (24-48 months) prior to data collection
* Subfascial, submuscular, dual plane or subglandular implant placement

Exclusion Criteria:

* Breast augmentation for Poland Syndrome or amastia
* Breast reconstruction following mastectomy
* Revision or secondary breast reconstruction
* Non NATRELLE® INSPIRA® device implanted at initial breast augmentation
* Women diagnosed with breast disease considered to be pre-malignant or malignant prior to or at the time of primary breast augmentation
* Surgical procedures of the breast not related to the primary breast augmentation (e.g. excision of significant skin lesions or a biopsy) occurring prior to or at the time of primary augmentation that may adversely affect the aesthetic outcome in the opinion of the investigator
* Axillary or peri-areolar approach
* Mastopexy augmentation
MODY in Young-onset Diabetes in Different Ethnicities

The purpose of this study is to describe and compare the different types of diabetes that exist in people from white European and south Asian origin in the UK (United Kingdom) who are diagnosed with diabetes before they turn 30 years old. By doing this we hope to identify cases of MODY (maturity onset diabetes of the young), which is a rare genetic cause of diabetes that is frequently misdiagnosed. Identifying MODY cases is important, as the treatment may differ to conventional treatment for type 1 or type 2 diabetes.

People who meet the recruitment criteria, will be invited to attend for a single fasted 2 hour visit at our research facility. During the visit we will record details of their diabetes history as well as their general health and undertake blood and urine tests. At the end of the visit their participation will be complete. We will contact them later to discuss results of specialist blood tests and whether or not they have MODY, if they have had genetic testing performed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with diabetes on the basis of fasting glucose and/or oral glucose tolerance test and/or HbA1c as per WHO criteria.
* Diagnosed with diabetes between 6 months and 30 years of age.
* South Asian ancestry- defined as self-reported ancestry and at least 2 grandparents from the Indian Subcontinent (India, Pakistan, Bangladesh or Sri Lanka).
* European ancestry - defined as self-reported ancestry and at least 2 grandparents from within Europe.

Exclusion Criteria:

* An established secondary cause of diabetes exists (for example recurrent pancreatitis, pancreatectomy, new onset diabetes after transplantation, Cushing's syndrome, acromegaly, steroid induced).
* Enrolled in another study.
* Have active malignancy or under investigation for malignancy.
Effects of Korean Red Ginseng Extract on Electrical Brain Activity in Elderly Subjects

A prospective, randomized, double blind, placebo-controlled study to determine if a hydroponically-cultivated red ginseng preparation is superior to conventionally grown ginseng and placebo for positively affecting electrical activity of the brain during performance of various cognitive tasks.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be capable of giving informed consent.
* Acceptance of written consent to participate in the study after instruction in written and oral form (informed consent).

Exclusion Criteria:

* Subjects with acute or chronic diseases that are relevant to the study and asked for by the study staff are excluded:
* Acute or chronic disease with an impact on the study, which becomes obvious by case history or clinical examination.
* Clinically relevant allergic symptoms.
* Detection of alcohol at the time of initial examination (day SC) or on any study (positive alcohol test) or by case history.
* Consumption of clinically relevant medication during last 14 days before and during the active study period based on the notification of the subject or his case history.
* Consumption of medication with primarily central action (i.e. psychotropic drugs or centrally acting antihypertensive drugs). Known intolerance / hypersensitivity (allergy) to plant derived extracts or any of the ingredients of the investigational product (anamnestic).
* Consumption of unusual quantities or misuse of coffee (more than 4 cups a day), tea (more than 4 cups a day).
* Smoking in the study center on study days A, B, C and D.
* Participation in another clinical trial within the last 60 days.
* Bad compliance.
* Cancellation of informed consent.
A Study of SHR-1210 Plus Apatinib in Patients With Soft Tissue Sarcoma

The main purpose of this study is to evaluate the efficacy of SHR-1210 plus Apatinib versus AMD plus IFO in participants with soft tissue sarcoma.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects with the age from 16 years to 70 years.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;the ECOG performance status of 2 can be accepted after the amputation.
* Life expectancy of at least 3 months.
* Histologically confirmed diagnosis of advanced unresectable or metastatic soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy.The histopathologic types as specified in the protocol.
* Without prior systemic chemotherapy or relapse more than 6 months after the completion of last systemic chemotherapy.
* Presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
* Acceptable liver function, renal function, hematologic status and coagulation function as specified in the protocol.
* Females of child-bearing potential must have a negative serum pregnancy test within 7 days prior to randomization.Females of child-bearing potential and males must agree to use highly effective contraceptive precautions during the trial and up to 3 months following the last dose of study drug.
* Willingness to comply with the study protocol for any reason.

Exclusion Criteria:

* Receiving any previous anticancer treatment, other investigational drugs or any attenuated live vaccine with 4 weeks of the first does of study drug.
* Prior treatment with PD-1/PD-L1/CTLA-4 targeted drugs or VEGFR targeted drugs.
* Plan to receive surgery or radiotherapy to treat the sarcoma during the trail.
* Radiological evidence of brain metastases or primary tumors.
* Diagnosed other malignancies within the last 3 years from the first dose of drug.
* Known allergy to any of the treatment components.
* Active infection including human immunodeficiency virus (HIV) ,HBV or HCV.
* Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
Safety, Tolerability and Pharmacokinetics of Oral BIBP 5371 CL in Healthy Male and Female Volunteers

Safety, tolerability and pharmacokinetics (including comparisons of different formulations and investigation of food effect)


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers
* Age 21 - 50 years
* Body mass index (BMI) 18.5 - 29.9 kg/m2

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate, respiratory rate, body temperature and ECG) deviating from normal
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) within at least 1 month or less than 10 half-lives of the respective drug before enrolment in the study
* Use of any drugs which might influence the results of the trial (within 1 week prior to administration or during the trial)
* Participation in another trial with an investigational drug (within 2 months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 grams/day)
* Drug abuse
* Blood donation (≥ 100 mL within 4 weeks prior to administration or during the trial)
* Excessive physical activities (within the last week before the study)
* Any laboratory value outside the reference range of clinical relevance

In addition, for female subjects:

* Pregnancy
* Positive pregnancy test
* No adequate contraception e.g. oral contraceptives, intrauterine device, sterilisation

Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condoms) prior to administration of study medication, during the study and at least 1 month after release from the study

* Inability to maintain this adequate contraception during the whole study period
* Lactation period
Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Intra-Coronary Stem Cell Infusion-3-DES

This trial was performed to evaluate the safety of G-CSF based stem cell therapy and to compare outcome of intracoronary infusion of mobilized PBSCs between patients with AMI and OMI.

The MAGIC Cell-DES trial was designed as a randomized, controlled trial to recruit 100 patients with AMI and OMI. Patients who were successfully revascularized with DES in the culprit lesion were eligible for enrollment. After revascularization, patients were randomized by use of a randomization table. After randomization, study processes were not blinded.

In the cell infusion groups after successful PCI, PBSCs were mobilized by daily subcutaneous injections of G-CSF (Dong-A pharmaceutical, Seoul, Korea) at 10 g/kg body weight for three days. At day 4, mobilized PBSCs were collected with COBE spectra apheresis system (COBE BCT. Inc., Lakewood, CO, USA) using the mononuclear cell collection methods and infused selectively to infarcted myocardium via over-the-wire balloon catheter.

The primary end point to evaluate efficacy was the change in LVEF, measured by MRI. The secondary end points were changes in LV volume, myocardial perfusion measured by coronary flow reserve (CFR), and the development of major adverse cardiac events (MACE; death, new MI, revascularization, hospitalization due to aggravation of ischemia or heart failure).

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute or old myocardial infarction who were successfully revascularized with DES in the culprit lesion were eligible for enrollment.

Exclusion Criteria:

* 1) Persistent severe heart failure (left ventricular ejection fraction (LVEF) \< 20%) 2) Uncontrolled myocardial ischemia or ventricular tachycardia 3) Culprit lesion of infarct related artery not feasible for percutaneous coronary intervention (PCI) or unsuccessful PCI 4) Age \> 80 years 5) Malignancy 6) Serious current infection or hematologic disease; and 7) Life expectancy under one year.
Study of Cavosonstat (N91115) in CF Patients Who Are Heterozygous for F508del-CFTR and a Gating Mutation and Being Treated With Ivacaftor

Cavosonstat (N91115) is being studied as a potential novel therapy for cystic fibrosis (CF), and this study assesses a target population of patients who are heterozygous for F508del-CFTR and a gating mutation that is approved for treatment with ivacaftor (G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R).

Assess the effect of Cavosonstat (N91115) on lung function when added to preexisting treatment with ivacaftor in adult patients with CF who are heterozygous for F508del-CFTR and a gating mutation that is approved for treatment with ivacaftor (G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R).

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CF, heterozygous for F508del-CFTR and a gating mutation that is approved for treatment with ivacaftor (G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R)
* Have been treated with chronic ivacaftor twice daily for at least 6 months prior to Screening (date of consent) and are currently being treated with commercially available Ivacaftor
* Negative serum pregnancy test
* Weight ≥ 40 kg at screening
* Oxygen saturation by pulse oximetry ≥ 90% breathing ambient air, at screening

Exclusion Criteria:

* Any acute infection, including acute upper or lower respiratory infections and pulmonary exacerbations that require treatment that has completed within 2 weeks of Study Day 1 or hospitalization discharge within 2 weeks of Study Day 1
* Recent infection (per investigator discretion) with organisms associated with more rapid decline in pulmonary status, for example: Burkholderia cenocepacia, Burkholderia dolosa, and Mycobacterium abscessus
* Any change in the regimen for chronic therapies for CF lung disease (e.g., Pulmozyme®, hypertonic saline, Azithromycin, TOBI®, Cayston®) within 4 weeks of Study Day 1
* Blood hemoglobin \< 10 g/dL at screening
* Serum albumin \< 2.5 g/dL at screening
* Abnormal liver or renal function
* History of ventricular tachycardia or other clinically significant ventricular arrhythmias
* History, including the screening assessment, of prolonged QT and/or QTcF (Fridericia's correction) interval (\> 450 msec for men; \> 470 msec for women)
* History of solid organ or hematological transplantation
* History of alcohol abuse or drug abuse (including cannabis, cocaine, and opioids) in the year prior to screening
* Use of continuous (24 hr/day) or nocturnal supplemental oxygen
Immunogenicity of the ChAdox1 n CoV-19 Vaccine With 12-dose Vial

ChAd0x1 nCoV-19 (AZD 1222) is the main vaccine that is planned to roll-out in Thailand and involve vaccinating people especially in high-risk categories. This vaccine is contained in the multiple-dose vial for vaccinating 10 recipients for 0.5 mL each. However, the additional volume of vaccine was overfilled to 6.5 mL per vial which the vaccination can be administered to more than 10 doses. The University Hospital Network (UHOSNET) and Faculty of Medicine Vajira Hospital, Navamindradhiraj University have jointly stipulated the preparation and vaccination of ChAdox1 - n CoV-19 vaccine with 12 doses per vial injection with traditional 21 or 24 G needle. Taken together, The investigators planned to investigate the immune response of participants after first dose of ChAd0x1 nCoV-19 vaccination with such technique

The investigators measured anti-SARS-CoV-2 antispike RBD IgG and neutralizing antibody by surrogate virus neutralizing test (sVNT) in adults between age 18-72 year after first dose of ChAd0x1 nCoV-19 vaccine.The primary outcome was the antibody levels.The secondary outcome were adverse events,factors affecting antibody levels and incidence of COVID-19 infection at the time of study

Eligibility Criteria:
Inclusion Criteria:

* Participants were eligible if they were more than 18 years old.

Exclusion Criteria:

* Allergic to components of vaccine
* Risk of COVID-19 infection in the previous 14 days before enrollment i.e close contact with index cases or history of fever with upper respiratory tract infection.
Oral/Intramuscular B12 to Treat Cobalamin Deficiency

Objective: To determine the effectiveness of oral versus intramuscular Cobalamin (vitamin B12) by restore cobalamin parameter in blood at 8, 26 and 52 weeks in ≥ 65 aged patients with Cobalamin Deficiency.

Design: Noninferiority randomised controlled trial, pragmatic and multi-center in the primary healthcare setting (Madrid Region).

Participants: ≥ 65 aged patients with Cobalamin Deficiency. Patients give inform consent. Number of patients: 320 (160 each arm). Assignment: randomized simple (automatic system).

Variables. Main outcome variable: Cobalamin level standardization (yes/no). Secondary outcome variables: Adverse events. Adherence measurement of treatment. Health related quality of life questionnaire (Euroqol-5D). Satisfaction and preferences. Other variables: Gender. Age. Live alone. Vegetarian diet. Alcohols consume. Clinic Variables (symptoms and physical examination) and blood parameters. Drugs consume.

Causes of all losses and withdrawals. Number of patients (age and gender) who declined to participate.

All data (excluding patient identification data) will be record in an electronic database.

Intervention group: oral Optovite® B12 1000 gammas. Control group: idem intramuscular.

Analysis: Descriptive analysis (screening phase). Baseline comparison of the two intervention groups. Effect of cobalamin (main outcome variable). Security. Quality of life. Adherence measurement of treatment.

Variables. Main outcome variable: Cobalamin level standardization (yes/no). Secondary outcome variables: Adverse events. Adherence measurement of treatment. Health related quality of life questionnaire (Euroqol-5D). Satisfaction and preferences. Other variables: Gender. Age. Live alone. Vegetarian diet. Alcohols consume. Clinic Variables (symptoms and physical examination) and blood parameters. Drugs consume.

Causes of all losses and withdrawals. Number of patients (age and gender) who declined to participate.

All data (excluding patient identification data) will be record in an electronic database.

Intervention group: oral Optovite® B12 1000 gammas. Control group: idem intramuscular.

Analysis: Descriptive analysis (screening phase). Baseline comparison of the two intervention groups. Effect of cobalamin (main outcome variable). Security. Quality of life. Adherence measurement of treatment.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 65 aged patients with Cobalamin Deficiency.
* Patients give inform consent.

Exclusion Criteria:

* Treatment with B12 (1 last year)
* Neurologic or psychiatric pathologies
* Folic acid \< 2.3ng/ml ...