cyrilzakka/clinical-trials huggingface dataset:
Pazopanib for Metastatic Alveolar Soft Part Sarcoma

Alveolar soft part sarcoma (ASPS), a rare subset of STS (\<1%) harbors t(X;17)(p11;q25) translocation and produces resultant ASPL-TFE3 fusion protein. Due to its nature of high expression of angiogenic factors, sunitinib and cediranib produced overall response rates of 55% and 43%, respectively. However, the efficacy of pazopanib is unknown in metastatic ASPS.

Pazopanib, a multi-targeted anti-angiogenesis inhibitor significantly prolonged progression-free survival (PFS) in patients with metastatic soft-tissue sarcoma (STS) after failure to anthracycline-based regimen (pazopanib vs placebo, 4.6 vs 1.6 months, HR=0.31, 95% CI 0.24-0.40; P \< .0001). Regarding sunitinib (continuous daily dose of 37.5mg), after a median duration of 10 months, median OS and PFS were 19 months and 17 months, respectively in a small retrospective study (ASPS, N=9). With regard to cediranib, 6-month PFS was over 60%. In addition, randomized phase II trial of sunitinib vs cediranib with cross-over at disease progression was recently initiated (NCT01391962). However, the efficacy of pazopanib is unknown in metastatic ASPS.

Eligibility Criteria:
Key Inclusion Criteria:

* Histologically confirmed diagnosis of alveolar soft part sarcoma harboring TFE3 fusion at stage IV or at relapse
* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Measurable lesion defined by RECIST v1.1
* Chemo-naïve or prior chemotherapies
* Adequate organ function

Exclusion Criteria:

* Prior malignancies
* Active CNS disease
* High-risk for gastrointestinal bleeding
* Significant cardiovascular disease
* Uncontrolled hypertension
* Bleeding diathesis
Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis

The study evaluates the efficacy and safety of fosfomycin and imipenem for the treatment of methicillin-resistant staphyloccocus aureus infective endocarditis in comparison to vancomycin, the standard therapy.


Eligibility Criteria:
Inclusion Criteria:

* Suspected methicillin-resistant staphyloccocus aureus infective endocarditis on a native valve, prosthetic valve or pacemakers´s electrode or defibrillators with definitive or probable diagnosis by the modified Duke criteria (Li J, et al. Clin Infect Dis. 2000).
* Patients over 18 years.

Exclusion Criteria:

* Patients who did not sign informed consent.
* Patients with active consumption intravenous drug.
* Patients with emergent surgery criteria (\<72 hours).
* Patients or cardiogenic shock.
* Patients with antibiotic active against MRSA over 72 hours or they may need another antibiotic active against MRSA than those in the study.
* Patients with chronic renal failure on hemodialysis who received empirical treatment with vancomycin as a single dose and have a valley ≥ 15 mcg / mL on the third day.
* Patients with MRSA strains resistant to fosfomycin (MIC\> 64 mg / L) (\<10%) or vancomycin (MIC\> 2 mg / L) or with an MIC to vancomycin of 2 mg / L.
* Patients with any formal contraindication to be treated with study drugs
* Patients treated with any investigational drug within 30 days prior to entering the study.
Improving Clinical Trial Awareness in NSCLC: Pilot Testing A Novel Healthcare IT Platform for Incorporating Education at the Point of Care

The objective of this study is to 1) evaluate the impact of a novel individualized care planning/ educational technology (the On Q Care Planning System or CPS) on oncology patient and provider knowledge, attitudes and beliefs about Non-Small Cell Lung Carcinoma (NSCLC) clinical trials, as well as 2) to evaluate the impact of the On Q CPS on patient referral to and enrollment in NSCLC clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* All participants must be 18 years of age or older.
* Patient participants must have Stage III, IV and/or recurrent NSCLC.
* Patient participants must be at a point of treatment initiation/change or evaluation for treatment initiation/change
* Patients must have working email address and internet access

Exclusion Criteria:

* Any participant who cannot understand written or spoken English.
* Any participant who is not competent to provide informed consent for study participation per the investigator.
* Any participant who cannot be present for the related study visits and/or complete the post-test assessment
Study to Assess the Efficacy and Safety of Favipiravir-HU

The aim of the study is to assess the safety and efficacy of Favipiravir HU when administered to SARS-Cov- 2 patients in order to offer a safe and effective treatment to SARS-Cov-2 infection during the pandemic. The study is not for registration purposes and is not part of a series of studies for registration of Favipiravir HU.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients between the ages of 18 and 65 years.
2. Patients with PCR confirmed SARS-CoV-2 infection
3. Asymptomatic or have mild only symptoms and symptoms are onset less than 5 days
4. Signed Informed Consent Form and Patient Information Leaflet

Exclusion Criteria:

1. Pregnant or possibly pregnant patients or lactating females
2. Patients have moderate to severe or immediately life-threatening COVID-19
3. Major risk factor onset (Obesity, Diabetes, COPD, Hypertension)
4. Patients with SpO2 less than 95% without oxygen therapy
5. Patients with severe hepatic impairment equivalent to Grade C on Child-Pugh classification
6. Patients with renal impairment requiring dialysis
7. Patients with disturbed consciousness such as disturbed orientation
8. Female patients who are woman of childbearing potential and unable to consent to use of dual contraception from the start of favipiravir administration to 30 days after the end of favipiravir administration. Dual contraception is a combination of two of the following: Barrier method of contraception: condoms (male or female) with orwithout a spermicidal agent, diaphragm or cervical cap with spermicide; IUD; Hormone-based contraceptive; Tubal ligation
9. Male patients whose are unable to consent to use of barrier method of contraception (condom) the start of favipiravir administration to 90 days after the end of favipiravir administration. Male patients who are planning to donate sperm in 90 days after the start of favipiravir administration.
10. Patients with hereditary xanthinuria
11. Patient with severe uncontrolled hyperuricaemia
12. Patients receiving immunosuppressants
13. Patients who received interferon-alpha or drugs with reported antiviral activity against SARS-CoV- 2 (hydroxychloroquine sulfate, chloroquine phosphate, lopinavir-ritonavir combination, ciclesonide, nafamostat mesylate, camostat mesylate, remdesivir, etc.) within 72 hours or Patients who receive forbidden concomitant medication
14. Any medical condition that the examining physician deems unsuitable for the patient to participate in the study
The Safety and Immunogenicity of Haemophilus Influenzae Type b Vaccine in Different Injection Site

The objective of this study was to evaluate the safety and immunogenicity of Haemophilus influenzae type b vaccine in different injection site.

A randomized trial was conducted in 680 healthy infants with Hib vaccine of two brands. The different sub-groups were selected randomly based on the plan to inoculate vaccines in the upper arm deltoid or vastus lateralis muscle. The safety and immunogenicity were assessed after three or two doses.

Eligibility Criteria:
Inclusion Criteria:

* participants were under 1 years old, and were in good healthy
* participants were full-time pregnancy and birth weight were more than 2.5 kg

Exclusion Criteria:

* current infectious fever or acute disease
* a history of hypersensitivity to study vaccine components especially tetanus toxoid
* a history of allergy, autoimmune, convulsions, seizures heredity disease
* a history of Hib vaccination or Hib disease
* a history of congenital deformity, developmental disorders or serious chronic diseases, muscle injection contradiction, and immunosuppressive agents, hormone or immunoglobulin received.
Predictive Value of Embryonic Testing

The primary objective of this study is to determine the predictive value of preimplantation genetic screening (PGS) as a marker of embryonic competence. Secondary objectives are to define the related or independent predictive values of other proposed markers of embryonic and maternal reproductive competence in assisted reproductive technology (ART) cycles.

Patients participating in the study will undergo a routine in vitro fertilization cycle. Trophectoderm biopsy will be performed on all blastocysts however biopsy samples will not be analyzed till the clinical outcome has been determined. The single, morphologically best embryo available will be selected for transfer. All clinical and laboratory care is identical to that of which subjects would receive if they were not participating in the study. This includes all pretreatment screening, in-cycle treatment, embryology procedures, single embryo transfer, pregnancy testing, and pregnancy follow-up (if pregnancy occurs).

Eligibility Criteria:
Inclusion Criteria:

1. Couples electing embryonic aneuploidy screening (PGS)
2. Couples electing single embryo transfer

Exclusion Criteria:

1. Any prior failed IVF cycle
2. Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid
3. Diagnosis of chronic endometritis
4. Maximum day 3 FSH level of 12 or higher
5. Anti-mullerian hormone level less than 0.5 g/mL, tested within previous year
6. Total basal antral follicle count less than 8 follicles
7. Male partner with \<100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
8. BMI \<18.5 or \> 35
9. Personal history of recurrent pregnancy loss (two or more pregnancy losses)
10. Use of oocyte donation
11. Use of gestational carrier
12. Medical condition predisposing patient to high risk pregnancy
13. Use of surgical procedures to obtain sperm
14. Presence of hydrosalpinges that communicate with endometrial cavity
15. Any contraindications to undergoing in vitro fertilization or gonadotropin stimulation
16. Single gene disorder or chromosomal rearrangement requiring a more detailed embryonic genetic analysis
Arm Pump in Motorcross Training

Arm Pump is a sport specific term drivers use to describe Acute or Chronic Compartment Syndrome of the forearm. Drivers experience pain in the forearms due to increased blood pressure in forearm muscle compartments. No strategies nor methods have been used to diminish the risk to suffer from arm pump within motor cross.

This project aims to look at ergonomics of driving and its relationship with the occurrence of arm pump.

The investigators will first investigate the experience of motor cross athletes with arm pump through motor cross federations in Belgium and The Netherlands (survey).

Two groups of athletes will be selected (20 persons within each group) who will be invited to the motor cross track to investigate their hand grip strength, motor driving position, muscle activity.


Eligibility Criteria:
Inclusion Criteria:

* recreational or competitive motor cycling athletes
* with or without arm pump problems
* signing informed consent
* participation with their own motor bike
* Regular training hours

Exclusion Criteria:

* Inactive for more than 2 weeks before participation
* Pathology at shoulder, elbow or wrist level (except for arm pump)
Correlation of Campbell Score With Suicidal Ideation

The Campbell Score is a blood based means of assessing molecules believed to be associated with suicidal ideation and in some cases successful suicide.

The current clinical trial will assess the Campbell Score in 3 groups:

Group 1: 10 patients with no personal or family psychiatric history and no suicide attempts.

Group 2: 10 patients with suicidal ideation (Hamilton Depression Rating Scale suicide item \>2) and reported low acquired capability for suicide (Acquired Capability for Suicide Scale \<20).

Group 3: 10 patients with suicidal ideation (Hamilton Depression Rating Scale suicide item \>2) and reported high acquired capability for suicide (Acquired Capability for Suicide Scale \>60).

The goal of the study is to confirm efficacy of Campbell Score in identifying patients with high suicidal ideation potential.


Eligibility Criteria:
Inclusion Criteria:

* Capability of giving informed consent
* Agree to abide by the study protocol and its restrictions and be able to complete all aspects of the study.
* Be diagnosed with Suicide ideation/attempts/gestures

Exclusion Criteria:

- Not currently pregnant or lactating (due to potential confounding of brain activity as a result of differing hormone levels)
Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)

This trial studies how well a centralized care strategy works in improving the quality of smoking cessation and shared decision making among patients who smoke and are considering lung cancer screening. The centralized care strategy is a model where smokers eligible for lung cancer screening are referred to a dedicated tobacco treatment program where they receive both the shared decision-making and initiate smoking cessation counseling prior to their visit with a primary care provider. Utilizing the centralized care model may work better in helping people quit smoking and make informed decisions about lung cancer screening compared to usual care.

PRIMARY OBJECTIVE:

I. Test the effectiveness of usual care (primary care providers with training in guideline-based smoking cessation and shared decision making) versus (vs.) centralized care (smoking cessation and shared decision making delivered remotely by trained counselors) on smoking abstinence and the quality of patients' decisions about lung cancer screening.

SECONDARY OBJECTIVES:

I. Evaluate the reach, acceptability, feasibility, and fidelity of the two smoking cessation and shared decision-making implementation models in meeting the requirements from Centers for Medicare \& Medicaid Services (CMS) for the lung cancer screening patient counseling and shared decision making visit.

II. Conduct budget impact and cost-effectiveness analyses of the two implementation models for the smoking cessation and shared decision making to inform adoption of the intervention beyond the current study.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I (CENTRALIZED CARE): Participants receive counseling over the phone to help them quit smoking and learn about lung cancer screening over 15-20 minutes for 6-8 sessions over 8 weeks. Participants may also receive nicotine patches.

GROUP II (USUAL CARE): Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit.

After completion of study, participants are followed up at 1, 8, and 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* PATIENTS: Primary care patients
* PATIENTS: Upcoming primary care office visit
* PATIENTS: Current smoker
* PATIENTS: 30 plus (+) pack-year smoking history
* PATIENTS: English-speaking
* PROVIDERS: Primary health care providers
* PROVIDERS: Provide care to adults

Exclusion Criteria:

* PATIENTS: History of lung cancer by self-report
Immune Response to Varicella Vaccination in Children With Atopic Dermatitis

Atopic dermatitis (AD) causes people to be susceptible to skin infection and inflammations. The purpose of this study is to determine the immune response to chicken pox vaccine in children with or without AD who received the vaccine 2 to 16 weeks prior to the study visit.

AD is a chronic inflammatory skin disorder characterized by recurrent viral skin infections. Children with AD given the smallpox vaccine could develop a life-threatening condition known as eczema vaccinatum. This immune response is not currently understood. The purpose of this study is to understand the immune response to a viral vaccine in children with AD. This will be accomplished by studying immune response to the chicken pox vaccine in children with AD in comparison to those without AD.

This study will consist of one study visit occurring about 2 to 16 weeks after the child received the chicken pox vaccination. During this visit, physical and skin exams will occur. Personal and family medical histories and blood collection will also occur. The chicken pox vaccine will not be given as a part of this study. Subjects will receive the results of radioallergosorbent (RAST) testing that will tell if they are allergic to some common items (e.g., mold, grass).

Eligibility Criteria:
Inclusion Criteria:

* Parent/guardian has signed informed consent
* Male or female of any race or ethnicity
* 12 to 36 months of age, inclusive
* Healthy subjects with no systemic disorders and subjects with moderate to severe AD including a group of subjects with ADEH+
* Previously vaccinated for varicella by a physician 3 weeks prior to the Study Visit (subjects receiving the vaccine 2-16 weeks prior will also be accepted)

Exclusion Criteria:

* History of infection with chicken pox
* Oral, intravenous, or intramuscular corticosteroids within 30 days prior to chicken pox immunization
* Asthmatics receiving more than 500 micrograms per day of inhaled budesonide or more than 220 micrograms per day of inhaled fluticasone
* Antiherpes antiviral agents within 7 days prior to immunization
* Suspected immune deficiency or family history of primary immunodeficiency
* History of or active cancer
* Active untreated tuberculosis (TB)
* Respiratory illness at the time of chicken pox vaccination
* Receipt of blood products or chicken pox zoster immune globulin within the last 5 months prior to study entry
Clinical Trial of Temisartan/Amlodipine & Rosuvastatin in Subjects With Hypertension and Hyperlipidemia

Randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with hypertension and hyperlipidemia.

This trial is a phase 3 study to evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with hypertension and hyperlipidemia.

In "Temisartan/Amlodipine/Rosuvastatin" treatment group, 60 subjects will be assigned and the subjects administer "Temisartan/Amlodipine/Rosuvastatin" 8 for weeks.

In "Temisartan/Amlodipine" treatment group, 60 subjects will be assigned and the subjects administer "Temisartan/Amlodipine" for 8 weeks.

In "Temisartan/Rosuvastatin" treatment group, 60 subjects will be assigned and the subjects administer "Temisartan/Rosuvastatin" for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Subjects with hypertension and hyperlipidemia

Exclusion Criteria:

1. Patients with known or suspected secondary hypertension
2. Other exclusions applied
Handgrip Training With and Without Blood Flow Restriction in Relation to Gender Among Healthy Young Adults

In this study Investigator will determine the effects of blood flow restriction training on hand grip strength using hand held dynamometer among healthy young adults and investigator also see effects of blood flow restriction training on forearm circumference using weighted measuring tape among healthy young adults along with correlation of male and female population following blood flow restriction training among healthy young adults.

(A randomized control trial will be conducted in Foundation University Institute of Rehabilitation Sciences on 56 healthy young adults. Study will be conducted in 6 months (May 2020 to December 2020). Healthy young adults of both genders between 20-40 years of age will be included in the study. Adults with any diagnosed cardiovascular, metabolic, orthopedic or neurological disease, active/ongoing infection, recent history of upper extremity fracture or history of vascular medication will not be included in this study. The outcome variables will be hand grip strength measured through hydraulic hand held dynamometer and forearm circumference through anthropometric measuring tape.After assessment and screening, subjects will be randomly allocated in Control group "A" receiving low intensity strength training and Interventional group "B" receiving blood flow restriction training along with low intensity strength training via lottery method.Each participant will receive three sessions per week for two consecutive weeks making 6 treatment sessions in total. The outcome variables will be assessed at the start of 1st session and then at 6th session. To carry out the anthropometric assessment, anthropometric tape for circumference measurements, a digital scale for measuring weight and a stadiometer to measure height will be used.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults of sedentary lifestyle
* Young healthy adults following 6 minutes' Walk test
* Young healthy adults following YMCA 3 minutes Step test

Exclusion Criteria:

* Any diagnosed cardiovascular, metabolic, orthopaedic or neurological disease
* Active/ongoing infection
* Recent history of upper extremity fracture
* History of vascular medication
Intraoperative Optic Nerve Sheath Diameter Changes After Laparoscopic Surgery

Laparoscopic surgery is a widely used alternative to open surgery; Advantages include reduced bleeding and pain intensity, shorter hospital stay, and improved cosmetic results.

Laparoscopic surgery involves the creation of a carbon dioxide (CO2) pneumoperitoneum to facilitate a clear surgical view, which can result in increased intracranial pressure (ICP).

Ultrasonographic measurement of optic nerve sheath diameter (ONSD) is a simple, non-invasive, yet reliable technique for ICP assessment.Ultrasonographic assessment of optic nerve sheath diameter (ONSD) has been proposed as a non-invasive measurement of intracranial pressure.

Ultrasonographic measurement of optic nerve sheath diameter (ONSD) is a simple, non-invasive, yet reliable technique for ICP assessment. Previous studies have demonstrated that ultrasonographic measurement of ONSD correlates with the degree of ICP and can detect intracranial hypertension in a variety of clinical settings.

It was planned to measure the optic nerve sheath throughout the surgery with the help of a linear ultrasound probe.

Ultrasonographically, in each measurement, the optic nerve sheath diameter (ONSD) was detected 3 mm behind the entry point of the optic nerve into the globe in both eyes. ONSD will be measured bilaterally 3 mm behind the papilla. It will be evaluated by transverse measurement for each optic nerve.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 aged patients
* American Society of Anesthesiologists Classification (ASA) I-II-III patients
* Patients undergoing laparoscopic surgery

Exclusion Criteria:

* American Society of Anesthesiologists Classification (ASA) IV-V patients
* Those with known ophthalmic disease
* Those with a history of ophthalmic surgery
* Those with any known neurological disorder
* History of intracranial hypertension
* Patients who will undergo open abdominal surgery