cyrilzakka/clinical-trials huggingface dataset:
A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations

The purpose of this study is to evaluate the efficacy of erdafitinib in terms of overall response rate (ORR) in adult and pediatric participants with advanced solid tumors with fibroblast growth factor receptor (FGFR) alterations (mutations or gene fusions). It will also evaluate ORR in pediatric participants with advanced solid tumors and FGFR alterations.

Erdafitinib is a selective and potent pan FGFR 1-4 inhibitor with demonstrated clinical activity in participants with metastatic urothelial cancer and cholangiocarcinoma identified to have alterations in the FGFR pathway. This study targets the underlying altered biology of FGFR-driven tumors irrespective of solid tumor histology subtype. The study consists of screening phase, treatment phase and the post treatment follow-up phase (from the end of treatment visit until the participant has died, withdraws consent, is lost to follow-up, or the end of study, whichever comes first). End of study is considered as the time when the last participant receives the last dose of study drug on the study and either all pediatric participants are off study or until the most recently enrolled pediatric participant still participating in the study has 6 months of follow-up, whichever occurs first. Currently this study is recruiting pediatric participants only.

Eligibility Criteria:
Inclusion Criteria:

* Histologic demonstration of an unresectable, locally advanced, or metastatic solid tumor malignancy with an fibroblast growth factor receptor (FGFR) mutation or FGFR gene fusion
* Measurable disease
* Participant must have received at least one prior line of systemic therapy in the advanced, unresectable, or metastatic setting; or is a child or adolescent participant with a newly-diagnosed solid tumor and no acceptable standard therapies
* Documented progression of disease, defined as any progression that requires a change in treatment, prior to full study screening

Exclusion Criteria:

* Has had prior chemotherapy, targeted therapy, or treatment with an investigational anticancer agent within 15 days or less than or equal to (\<=) 5 half-lives of the agent (whichever is longer) and up to a maximum of 30 days before the first dose of erdafitinib
* The presence of FGFR gatekeeper and resistance mutations
* Histologic demonstration of urothelial carcinoma
* Hematologic malignancy (i.e., myeloid and lymphoid neoplasms
* For non-small cell lung cancer participants only: pathogenic somatic mutations or gene fusions in the following genes: EGFR, ALK, ROS1, NTRK, BRAF V600E and KRAS
* Active malignancies other than for disease requiring therapy
Parkinson's Disease Evaluated by PET and the Effect of Memantine

Purpose of study: To investigate whether the NMDA antagonist Memantine has a substantial effect of brain metabolism in patients with Parkinson's disease (PD), using Positron Emission Tomography (PET).

Background: Disturbances in brain metabolism is thought to contribute to degeneration of neurons in brain of PD patients. Production of toxic oxygen radicals and presence of too much excitatory neurotransmitter (glutamate) due to over activity is involved. These factors can theoretically be alleviated by memantine.

Hypothesis: Memantine decreases metabolism in areas in PD brain known to be over-active. Decreases in cerebral blood flow and oxygen metabolism in these areas will be the consequence and this can be detected by PET.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's Disease (British Brain Bank Criteria)
* Age 50-70y

Exclusion Criteria:

* Tobacco use
* Any serious medical conditions (Heart disease, kidney disease, liver disease, endocrinological disorders etc)
* Metal implants contraindicating MR scan
* Drug use affecting the central nervous system
* Psychiatric disorders
* Head trauma or any disorders of the head, skull or brain
* Drug addiction or use of any kind of illegal substance affecting the central nervous system
* Pregnancy
Evaluation of Effectiveness and Safety of Bioresorbable Vascular Scaffold in Routine Clinical Practice

The purpose of this study is to evaluate the relative effectiveness and safety of Bioresorbable Vascular Scaffold compared to other (drug eluting stents) DES.


Eligibility Criteria:
Inclusion Criteria:

* Age 19 and more
* Intervention with Bioresorbable Vascular Scaffold
* Agreed with written informed consent form

Exclusion Criteria:

* Bypass graft surgery (CABG) recommended
* Lesion with previous bypass graft surgery (CABG)
* Severe calcification and/or severe tortuosity
* Contraindication to antiplatelet agent or Inability to take dual antiplatelet therapy within 1 year
* Life expectancy of 1year and under
* Subjects scheduled to receive cardiac surgery or serious non-cardiac surgery
* Cardiac shock
STI571 Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia

Phase I/II trial to study the effectiveness of combining STI571 and chemotherapy in treating patients who have chronic myelogenous leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. STI571 may stop the growth of leukemia cells. Combining chemotherapy and STI571 may kill more cancer cells

OBJECTIVES:

I. Determine the maximum tolerated dose of high-dose cytarabine when combined with imatinib mesylate in patients with blastic phase chronic myelogenous leukemia.

II. Determine the safety of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients. IV. Determine the frequency of hematologic and cytogenetic responses, duration of response, and survival of patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of cytarabine.

Phase I: Patients who have not previously received imatinib mesylate receive oral imatinib mesylate daily on days 1-35. Patients who have previously received imatinib mesylate for at least 28 days receive oral imatinib mesylate on days 22-35. All patients receive cytarabine IV over 2 hours every 12 hours on days 29-32. Patients with more than 5% residual blasts in bone marrow on day 28 receive a second course in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of cytarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that which 2 of 6 patients experience dose-limiting toxicity.

Phase II: Additional patients are treated at the dose level preceding the MTD. Patients are followed monthly.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic myelogenous leukemia in myeloid blast crisis

  * At least 30% blasts in bone marrow
* Philadelphia chromosome positive by cytogenetic analysis
* bcr/abl translocation by fluorescent in situ hybridization
* Ineligible for or refused allogeneic stem cell transplantation
* Not previously treated with imatinib mesylate OR currently receiving imatinib mesylate with stable disease on 2 bone marrow biopsies at least 2 weeks apart
* Performance status - ECOG 0-2
* See Disease Characteristics
* Bilirubin less than 3 times upper limit of normal (ULN)
* AST and ALT less than 3 times ULN
* Creatinine less than 2 times ULN
* No New York Heart Association class III or IV heart disease
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for at least 2 weeks after study for female patients and at least 3 months after study for male patients
* See Disease Characteristics
* No prior allogeneic bone marrow or peripheral blood stem cell transplantation
* At least 48 hours since prior interferon alfa
* At least 24 hours since prior hydroxyurea
* At least 6 weeks since prior busulfan
* No other prior chemotherapy for blast crisis (except hydroxyurea)
* Concurrent hydroxyurea or anagrelide for severe leukocytosis or thrombocytosis allowed
* At least 4 weeks since prior investigational agents
Effects of Lactobacillus Plantarum PS128 in Children With ASD

Autism spectrum disorder (ASD) is a neurodevelopmental disorder that can cause significant social, communication and behavioral deficits. Probiotics are regarded as active microorganisms. With sufficient amounts, probiotics can regulate intestinal flora, intestinal permeability, inflammation and antioxidant reactions in the body. These reactions may further promote health, regulate metabolic disease progression and prevent complications. Lactobacillus plantarum PS128 (PS128) was reported to be a psychobiotic in several animal and human studies which modulated the levels of neurotransmitters in different brain areas. This study is to evaluate whether the consumption of PS128 can improve the symptoms of patients with ASD. The current randomized, placebo-controlled trial was conducted to investigate the psychophysiological effects of PS128 in school children with ASD.


Eligibility Criteria:
Inclusion Criteria:

* (1) Age 7 to 12 years old.
* (2) PS128 group and placebo group: Children with autism spectrum disorder, confirmed by Autism Diagnostic Observation Schedule.
* (3) Normal control group: Children without autism spectrum disorder.

Exclusion Criteria:

* (1) Receiving antibiotics within one month.
* (2) Probiotics used in powder, capsule, or tablet in two weeks (except for Yogurt, Yogurt, Yakult and other related foods).
* (3) Patients with hepatobiliary gastrointestinal tract who have undergone surgery (except for hernia surgery and appendectomy)
* (4) Those with special diets (gluten-free, casein-free, high-protein, and ketogenic diet).
* (5) Those with a history of cancer.
* (6) Those who are allergic to lactic acid bacteria.
* (7) Not eligible judged by PI
Biological and Cognitive Marker of Neurodegeneration in Obstructive Sleep Apnea Patients

The goal of this observational study is to investigate biomarkers and neurocognitive markers of neurodegenerative processes in obstructive sleep apnea patients.

The main questions the study aims to answer are:

* Does neurodegeneration assessed by neurobiological markers and neurocognitive test performance exists in obstructive sleep apnea?
* Are these neurodegenerative markers are associated with the adherence to clinical prescribed positive airway pressure therapy?

Newly diagnosed patients with obstructive sleep apnea will be observed during the use of clinical prescribed positive pressure therapy. Different study related investigations take place before and six months after treatment start.

Researchers will compare after six months the group of adherent treatment participants with the non-adherent treatment participants group to investigate if differences in the observed neurobiological or neurocognitive parameters exist.


Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed obstructive sleep apnea
* clinical indication for start of positive airwas pressure therapy
* Age older than 18 years

Exclusion Criteria:

* neurodegenerative disease
* Multiple sclerosis
* Stroke within last 3 months
* Brain injury within last 3 months
* MoCA \&lt; 21 points
* higher degree chonic kidney disease (lower than 30 mL/min)
* regular use of sleep pills (e.g. Zopiclon, Mirtazapin, Daridorexant)
Efficacy of the Lumbar Stabilization and Thoracic Mobilization Exercises in Chronic Low Back Pain Patients

Chronic low-back pain (CLBP) is a heterogeneous group of disorders, which according to the new classification of the International Association for Pain Research (IASP), is recognized as an independent entity and belongs to a mixed type of pain caused by central sensitization , which is present for more than 12 weeks. Studies have found that lumbar segmental instability (LSI) is one of the most significant cause of lumbar pain through the movement of each spinal segment where degenerative changes were observed in the discs. The aim of this study was to compare the program of lumbar stabilization exercises in the open and closed kinetic chain, in relation to the program of lumbar stabilization exercises and thoracic mobilization in a closed kinetic chain, to evaluate the clinical efficacy of both exercise programs and determine whether initial pain intensity values and disability levels affect the outcome of patients with chronic low back pain. The study was conducted as randomized, single-blind, controlled trial in 80 chronic low-back pain (CLBP) patients of both sexes (35 male, 45 female), average age (48.45 +/- 10.22 years, treated at the Rehabilitation Clinic "Dr. Miroslav Zotović" in Belgrade between June 2017 and March 2018. Respondents were divided into two groups of 40 patients by simple randomization. Participants were given laser therapy, transcutaneous electrical nerve stimulation (TENS) and an eight-week kinesiotherapy that included exercises to strengthen the deep lumbar spine stabilizers. Retesting was done after 4 and 8 weeks. Patients who performed lumbar stabilization and thoracic mobilization exercises program in a closed kinetic chain had better functional recovery and a significant reduction in pain intensity compared to respondents who performed a lumbar stabilization program in opened and closed kinetic chain.


Eligibility Criteria:
Inclusion Criteria:

* patients with lumbar pain present for more than 12 weeks,
* pain during changing of the position,
* radicular pain.

Exclusion Criteria:

* Cauda equina syndrome,
* ankylosing spondylitis,
* thoracic deformities (pectus carinatum, excavatum),
* spina bifida,
* fractures,
* post-operative spinal conditions,
* diabetes,
* inflammatory processes,
* tumors,
* pregnancy.
Rosiglitazone Versus Rosiglitazone and Metformin Versus Rosiglitazone and Avandia in the Treatment of Nonalcoholic Steatohepatitis (NASH)

The purpose of this study is to evaluate the efficacy of rosiglitazone alone compared with rosiglitazone plus metformin or rosiglitazone plus losartan in the treatment of biopsy proven nonalcoholic steatohepatitis (NASH). This study was designed to answer the question: are there differences in the efficacy (as measured by histopathology and insulin resistance) of three different therapeutic modalities used to treat NASH?


Eligibility Criteria:
Inclusion Criteria:

1. Patients between 18-70 years old
2. Negative urine pregnancy test in females
3. History of elevated liver associated enzymes (ALT \> 40)
4. Liver biopsy within 1 year of screening in this study that shows histopathologic findings consistent with NASH

Exclusion Criteria:

1. ALT greater than three times normal
2. NYHA class 3 or 4 heart failure
3. Any congestive heart failure patient on insulin
4. Patients on one of the 3 study drugs within the past 3 months prior to enrollment
5. Alcohol consumption \>20 gm/day in a female and \> 30 gm/day in a male
6. Evidence of co-existent chronic liver disease to include viral hepatitis, Wilson's disease, autoimmune hepatitis, hemochromatosis, primary biliary cirrhosis, or primary sclerosing cholangitis
7. Serum creatinine on initial screening of greater than 1.4
8. Known hypersensitivity to rosiglitazone, metformin, or losartan
9. Known history of diabetic ketoacidosis
10. Female that is breastfeeding
11. Insulin dependent diabetic
Effect of Chronic Arsenic Exposure on Malnutrition of Under Five Children

Early life malnutrition is associated with later life health problems, Particularly Stunting, which is a height-for-age Z score less than -2 standard deviation of World Health Organization median.Underweight is weight-for-age Z score less than -2 standard deviation of World Health Organization median. Wasting is weight -for- height Z score less than -2 standard deviation of World Health Organization median.

prevalence of under-five stunting, wasting and underweight are 21% and , 8% and 6% respectively in Egyptian Demographic Health Survey 2014.

The main risk factors for growth restriction in children are maternal under nutrition during pregnancy, lack of exclusive breastfeeding, inappropriate complementary feeding and micronutrient intake and high prevalence of enteric infections. However, other environmental exposures may also play a role in growth restriction .

High concentrations of Arsenic, lead and cadmium in placenta are associated with poor fetal out come and low birth weight. Arsenic crosses the placenta causing suppression of insulin-Like Growth Factor 1.

When breastfeeding is exclusive, infants are unlikely to be exposed to Arsenic by other routes of exposure such as external foods, drinking water and foods made at home using Arsenic contaminated water.

Rational of the study. Improvement of under-five nutritional status is a global target. Although the exposure to arsenic has increased globally, it's impact on nutritional status has seldom been investigated.

Eligibility Criteria:
Inclusion Criteria:

female children from 2 to 5 years

Exclusion Criteria:

Severely ill children other than severely malnourished.

* Children with congenital anomaly.
* Relatives.
The Effects of Prednisone on HIV Levels and the Immune System

The purpose of this study is to see if it is safe and effective to give prednisone to HIV-infected patients.

Prednisone is a corticosteroid, a hormone produced by the body that inhibits immune cell responses. Prednisone may be able to lower the level of HIV in the body (viral load) by reducing the number of cells that HIV can infect. At the same time, prednisone may be able to increase CD4 cell counts (cells of the immune system that fight infection).

By inhibiting cellular activation, corticosteroids such as prednisone may inhibit HIV expression and reduce the population of potentially infectable cells. Furthermore, no studies have been performed to systematically evaluate immune function in prednisone-treated, HIV-infected patients or the immune mechanisms that may facilitate increases in CD4+ cell number. This study explores this issue.

Patients are separated into 2 arms according to whether or not they are currently receiving a protease inhibitor (PI) as part of their antiretroviral (ARV) therapy regimen (PI vs no PI therapy). Arm I: Current stable ARV therapy plus prednisone for 8 weeks, followed by 4 weeks at half the prior dose, then a 2-week taper. Arm II: Current stable ARV therapy plus prednisone placebo for 12 weeks.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Have a CD4 cell count of 200-600 cells/mm3 within 30 days of study entry. (This study has been changed. You now must have a CD4 cell count of 200-700 cells/mm3 within 45 days of study entry.)
* Have had your viral load measured within 30 days of study entry.
* Have been on stable anti-HIV therapy with at least two anti-HIV agents for at least 12 weeks, and you intend to remain on this therapy during the study.
* Are at least 18 years of age.
* Agree to abstain from sex or use effective methods of birth control during the study and for 30 days after.

Exclusion Criteria

You will not be eligible for this study if you:

* Abuse alcohol or drugs or have a serious psychological condition.
* Are allergic to prednisone or other corticosteroids.
* Have a history of opportunistic (AIDS-related) infections, including cytomegalovirus (CMV), Mycobacterium avium complex (MAC), or Kaposi's sarcoma (KS).
* Have a history of a serious medical condition, including heart problems, tuberculosis (TB), cancer, diabetes, or osteoporosis.
* Are being treated for herpes at study entry.
* Have received certain medications, including blood pressure medication.
* Are pregnant or breast-feeding.
Clinical Study of PAL-222 Targeting Patients With Myopic Chorioretinal Atrophy (PAMyCA)

The goal of this clinical trial is to assess efficacy and safety in patients with myopic chorioretinal atrophy.

The main question it aims to answer are:

• Percentage of changes in the chorioretinal atrophic area

Participants will be implanted one sheet of PAL-222 into the subretinal space through pars plana vitrectomy.

Researchers will compare non-therapeutic eye to see if the changes is significant different.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20 years or older at the time of consent acquisition
* Patients with binocular intensity myopia (myopia of -6.0 diopter (D) or more) or patients with axial length (26 mm) or more equivalent to -6.0 D
* Corrected characters of the test eye patients with visual acuity of less than 60 characters (equivalent to decimal visual acuity 0.32)
* Patients diagnosed with binocular myopic chorioretinal atrophy and having atrophy of 1 papillary diameter (1.5 mm) or more in the area within 2 papillary diameter (3.0 mm) including the fovea centralis in the subject eye
* Patients without active choroidal neovascularization

Exclusion Criteria:

* Patients with abnormal findings that pose a problem in clinical trial participation in screening tests.
* Patients with positive hepatitis B surface (HBs) antigen, Hepatitis C virus (HCV) antibody, Human immunodeficiency virus (HIV) antibody, Human T-lymphotropic virus type 1 (HTLV-1) antibody, syphilis serum reaction
* Patients with allergies to human serum albumin antibiotics, trypsin
* Patients with eye infections
* Patients with other retinal diseases (diabetic retinopathy, hypertensive retinopathy, vascular occlusion)
* Patients with confirmed optic nerve atrophy
* Patients with glaucoma who cannot control intraocular pressure
* Patients with findings associated with myopic traction macular disease (apparent posterior macular tumor, vitreous macular traction, retinal separation, macular hole detachment, macular hole)
* Patients with atrophy in all areas of the circle within 3 papilla diameter (4.5 mm) (9.0 mm in diameter) from the fovea
* Patients with corrected visual acuity of control eye 0.08 or less
* Patients with severe blood disorders, heart failure, liver disorders, and renal disorders
* Patients diagnosed with malignant tumor within 5 years or patients requiring treatment
* Pregnant women, lactating women, patients wishing to become pregnant during the trial period
* Patients who cannot discontinue anticoagulants or antiplatelet drugs before the trial
* Patients with drug addiction or alcoholism
* Patients receiving treatment with vascular endothelial growth factor inhibitor or photodynamic therapy within 4 months prior to transplantation for test eye or 2 months for reference eye.
* Patients who underwent eye surgery (excluding lens reconstruction) within 3 months before transplantation. In the case of cataract surgery, if 7 days or more have passed since surgery and postoperative inflammation is stable, registration is possible.