cyrilzakka/clinical-trials huggingface dataset:
Apatinib and Etoposide in Patients With Platinum Resistant or Refractory Ovarian Cancer

The purpose of the study is to evaluate the efficacy and toxicity of apatinib in patients with platinum resistant or refractory ovarian cancer when combined with etoposide.

Ovarian cancer is the leading cause of death for patients with gynecologic malignancies. In most cases, the disease is diagnosed at an advanced stage and approximately 75% of patients will eventually experience disease recurrence. However, the overall response rates of second-line chemotherapy for recurrent ovarian cancer are only 20-27%. Therefore, it is important to seek alternative agent that can improve the outcome. Apatinib is a novel vascular endothelial growth factor receptor 2 tyrosine kinase inhibitor and it has been approved for the treatment of advanced gastric cancer. The preclinical studies suggest apatinib may be effective in other cancers such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and safety of the study drug apatinib when combined with a standard treatment, etoposide, for patients with platinum resistant or refractory ovarian cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary.
* Platinum resistant ovarian cancer (defined as relapsing within 6 months after the last administration of platinum-based chemotherapy) OR platinum refractory ovarian cancer (defined as progressing while on a platinum-based chemotherapy)
* At least treated with one line of platinum-based chemotherapy
* Female, age ≥18 years and ≤70 years, signed informed consent.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version
* Patients must have a life expectancy of at least 3 months.
* Patients must have adequate organ function as defined by the following criteria:

  * White blood cell count ≥ 3 x 10\^9/L, Absolute neutrophil count (ANC) (≥ 1.5 x 10\^9/L), Hemoglobin of ≥ 80 g/L, Platelets ≥ 70 x 10\^9/L
  * Total bilirubin ≤ 1 x upper limit of normal (ULN), AST and ALT ≤ 2 x ULN
  * Serum creatinine ≤ 1 x ULN

Exclusion Criteria:

* Had prior exposure to apatinib or has known allegies to any of the excipients.
* History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.
* Patients with QT interval prolongation
* Serious, non-healing wound, active ulcer, bowel obstruction.
* History of abdominal fistula or gastrointestinal perforation within 28 days prior to Day 1
* Evidence of bleeding diathesis or coagulopathy
* Inadequately controlled hypertension
* Major surgical procedure within 28 days prior to Day 1
* Symptomatic central nervous system (CNS) metastasis
Treatment of Steroid Refractory Gastro-intestinal Acute GVHD afteR AllogeneiC HSCT With fEcal Microbiota tranSfer

Patients who have a gastrointestinal acute Graft versus host disease (GVHD) received a first-line standard treatment of corticosteroids. For patients who do not respond or progress after an initial response have a high mortality. There is an interest in identifying effective second line therapy for these patients corticosteroid-resistant acute GVHD. Fecal microbiota transfer might be a beneficial treatment in this clinical situation with a poor prognosis and limited therapeutic options.


Eligibility Criteria:
Inclusion Criteria:

* Patients who develop a first episode of Stage 2 to 4 Gastro-intestinal Acute Graft-versus-Host (GI-aGVHD) with gut predominance (Przepiorka D, 1995), resistant to a first line therapy with steroids (lack of improvement after 5 days or progression after 3 days of treatment with corticosteroids at 2 mg/Kg methylprednisolone equivalent dose) (SR GI-aGVHD)
* Age ≥ 18 years old
* Allogeneic Hematopoietic stem cell transplantation (Allo-HSCT) with any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen
* Patients able to have a minimum of 12 hours discontinuation of systemic antibiotics in order to perform the allogeneic FMT
* Signature of informed and written consent by the subject or by the subject's legally acceptable representative

Exclusion Criteria:

* Grade IV hyper-acute GVHD
* Overlap chronic GVHD
* Acute GVHD after donor lymphocytes infusion
* Relapsed/persistent malignancy requiring rapid immune suppression withdrawal
* Active uncontrolled infection according to the attending physician
* Other systemic drugs than corticosteroids for GVHD treatment (including extra-corporeal photopheresis). Drugs already being used for GVHD prevention (eg. calcineurin inhibitors) are allowed.
* Absolute neutrophil count \< 0.5 x 10\^9 /L
* Absolute platelet count \< 10 000
* Patient Epstein-Barr Virus (EBV) negative
* Evidence of toxic megacolon or gastrointestinal perforation on abdominal X-ray
* Known allergy or intolerance to trehalose or maltodextrin
* Pregnancy: positive urinary or blood test in female of childbearing potential; lactation; absence of effective contraceptive method for female of childbearing potential
* Other ongoing interventional protocol that might interfere with the current study primary endpoint.
TAVR for Aortic Valve Disease

Transcatheter aortic valve replacement (TAVR) has became an important treatment of severe aortic stenosis (AS). Several randomized clinical trials showed that TAVR was non-inferior or superior to surgical aortic valve replacement (SAVR). However, many different issues have emerged: TAVR in younger patients? valve leaflet thrombosis? transcatheter valve durability? coronary reaccess after TAVR? TAVR in bicuspid aortic valve? TAVR in aortic regurgitation? etc. Hence, a prospective, multicenter database is created to provide the real-word data for these questions.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of severe aortic stenosis or aortic regurgitation
2. Patients undergo transcatheter aortic valve replacement

Exclusion Criteria:

patients refuse the clinical follow-up
A Pharmacokinetic/Pharmacodynamic Study of RO5185426 in Previously Treated Patients With Metastatic Melanoma

This open-label study will assess the pharmacokinetics, efficacy and safety of RO5185426 administered as 240mg tablets in previously treated patients with metastatic melanoma. Patients will be randomized to receive one of four dose-levels of RO5185426 \[RG7204; PLEXXIKON; PLX4032\] orally twice daily on days 1 to 15 (morning dose). Starting on day 22, treatment with RO5185426 may be resumed at a dose of 960 mg twice daily and continued until disease progression. Target sample size is \<100 patients.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>/=18 years of age
* histologically confirmed metastatic melanoma, stage IIIc or IV (AJCC)
* failure of at least one prior standard of care regimen
* positive for BRAF V600E mutation (by Roche CoDx BRAF mutation assay)
* ECOG performance status 0 or 1
* adequate hematologic, renal and liver function

Exclusion Criteria:

* active CNS lesions on CT/MRI within 28 days prior to enrollment
* history of spinal cord compression o carcinomatous meningitis
* anticipated or ongoing anti-cancer therapies other than those administered in this study
* previous treatment with BRAF inhibitor (sorafenib allowed) or MEK inhibitor
* severe cardiovascular disease within 6 months prior to study
* previous malignancy within the past 5 years except for basal or squamous cell carcinoma of the skin, melanoma in-situ and carcinoma in-situ of the cervix
Use of a Synthetic Macromolecule (Hydroxypropyl Cellulose ) and Trehalose as Additives for Oocyte Vitrification

This study is aimed to evaluate the use of Hydroxypropyl Cellulose (HPC) as substitute for the traditional protein supplement (Synthetic Serum Substitute; SSS) and Trehalose as substitute for the most widely used sugar (Sucrose) in the vitrification solutions employed for oocyte vitrification.

Vitrification involves the transformation of an aqueous solution into a very viscous solid avoiding ice formation. To achieve this, the vitrification protocols include high concentrations of cryoprotectants dissolved in a base medium supplemented with serum rich in protein. Traditionally available preparations contains human albumin (HSA). The most commonly used in vitrification solutions is the synthetic serum replacement (SSS) consisting of synthetic glycoporoteins and HSA. The replacement of human albumin by other fully synthetic components enables compliance with the European directives for classification of Class III medical device in accordance with the Manual for the Classification of Medical Devices in the regulatory framework of the European community, and therefore these media have the European CE conformity marking (Directive 93/42/EEC). According to European regulations, Class III medical devices are subject to special supervision and require certification exam or design type examination by a notified body. Commercial media supplied by Kitazato supplies ® (Tokyo, Japan) to be used in this study have been submitted to the whole process of evaluation and certification by the notified body BSI0086. Because of physical properties of hydroxypropyl cellulose (HPC), fully synthetic macromolecule, including the ability to form a viscous gel at low temperatures, this macromolecule has been proposed as a substitute for human origin albumin (HSA). Another necessary component of vitrification media is sucrose, which acts as an osmotic agent. Trehalose, a disaccharide present in nature is used by certain species to survive extreme conditions, being able to remain vitrified for years. This sugar has also been employed previously in cryobiology in some vitrification protocols. We have tested HPC and threhalose for oocytes vitrification in a pilot study, showing that no impairment in the survival rates, embryo development and pregnancy rates. The current study is a prospective randomized trial aimed to assess the outcome of ovum donation cycles conducted with vitrified oocytes using HPC and trehalose versus oocytes vitrified using traditional available solutions containing HAS and sucrose.

Eligibility Criteria:
Inclusion Criteria:

Donors:

* \< 35 years old
* Normal physical and gynecological examinations
* No family history of hereditary or chromosomal diseases.
* Normal karyotype
* Negative screening for sexually transmitted diseases.

Oocyte recipients:

* Oocyte recipients \< 50 years old
* Body mass index\< 30
* \< 2 previous IVF failures
* No severe male factor
* No recurrent miscarriage
* No hidrosalpinx
* No myoma
* No adenomyosis
* No AMH alterations

Exclusion Criteria:

Donors and recipients not meeting inclusion criteria
A Single, Ascending Dose Evaluation of the Safety, Pharmacokinetics of Methylone in Healthy Subjects

This is an open-label, single, ascending dose study evaluating the PK and safety of methylone in healthy subjects.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy adult male or female aged 25 to 55 inclusive
* Normal resting ECG
* Normal hematologic and hepatic function
* Normal renal function

Key Exclusion Criteria:

* Vital sign abnormalities
* Positive urine drug screen at screening and / or Day -1
* Current mental illness such as depression, anxiety disorder, schizophrenia or other psychotic disorders
Semen Processing for ICSI Using Swim-down and Density Gradient Methods

The investigators evaluate the feedback of using swim down semen processing method during preparation for ICSI and compare the results of pregnancy and embryos quality with the cases used density gradient method for their semen processing.

There is different semen processing method, in this study we compared the ICSI output when the investigators used one method with higher separation method and minimum sperm stress or physical interface as swimming down using 100 % silica solution, with other more stressful procedure with high selection power as density gradient.

The routine used method as density gradient (DG) includes about 30 min centrifugation at 1200 RPM, and more working steps with more handling procedures. According to many references the investigators can approve that it is method to be indicated with all cases particularly with those severely decreases semen number or motility.

Using 100 % silica solution for semen processing used for ICSi, shews lesser centrifugation time and minimum processing procedures. As swimming down time is about 30 min followed by 5 min washing and finalized with other 3 minutes last wash. For that total interfering physical action is about 8 minutes compared with 30 min with DG method.

In swimming down we are using the natural sperm behavior and own swimming power for separate itself from other seminal components. As well as only the one normally structure and motility direction the only can penetrate the interface surface of silica solution and swim inside higher density matrix using its speed and power.

Eligibility Criteria:
Inclusion Criteria: all semen samples fresh or frozen that has,

* Cases have semen examination criteria fall within WHO 2010 standards of count
* Cases have semen examination criteria fall within WHO 2010 standards of motility
* Cases have semen examination criteria with all types of abnormal forms
* Cases produced more than 4 mature oocytes (M2) and more

Exclusion Criteria:

* Cases have semen examination criteria with motility less than 5%
* Cases have semen examination criteria with count less than 1.0 million
* Cases with TESE, TESA and EPSA, both fresh and frozen
* Cases produced less than 4 mature oocytes (M2)
A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.

Double-blind, Placebo-controlled study to confirm the superiority of MR13A9 to placebo, and followed by extension, open-label treatment to confirm long-term safety of MA13A9 in hemodialysis patients with pruritus.


Eligibility Criteria:
Inclusion Criteria:

* Patient with Chronic Kidney Disease (CKD) has been on hemodialysis 3 times per week
* Patient receiving treatment for itch
* Patient has a baseline NRS score \> 4

Exclusion Criteria:

* Patient has pruritus cause other than CKD or its complications
* Patients has hepatic cirrhosis
* Patient has a known history of allergic reaction to opiates
High-resolution Phosphocreatine and Creatine Mapping of Human Muscle and Brain

In this study, we aim to develop and validate a noninvasive approach for quantifying and imaging energy metabolism, without contrast agents, on widely available clinical MRI scanners. Briefly, this technique allows specific and selective imaging of the energy metabolite phosphocreatine (PCr), in vivo and non-invasively. PCr is one of the predominant high-energy phosphates present in brain and muscle and one that is altered by common diseases. Although energy metabolism and PCr play a vital role in cellular homeostasis, there currently are no routine diagnostic tests to noninvasively quantify or map the distribution of PCr with clinically acceptable spatial resolution or/and scan time. Here, we demonstrate that the exchangeable guanidinium protons of millimolar concentration PCr can be exploited to detect it via the water signal in MRI with greatly enhanced sensitivity (molar signal) using chemical exchange saturation transfer (CEST) MRI, and its concentration can be quantified using an artificial neural network (ANN). This new technique, dubbed ANNCEST, allowed us to obtain a high-resolution PCr map on human skeletal muscle within 1.5 min, on a 3T clinical MRI scanner equipped with just the standard MRI setup. To put this in a larger perspective, energy metabolism is critical for cell viability and is altered by many common acquired and inherited diseases. ANNCEST is arguably the first to use widely available MRI scanners to noninvasively image tissue energy metabolism of PCr, and thus would have appeal to a broad readership of scientists and clinicians interested in neurology, muscular dystrophies and myopathies as well as cardiology, to name a few.


Eligibility Criteria:
Inclusion Criteria:

Subject must be at least 18 years of age Subject must be willing and able to undergo verbal and written informed consent Healthy subjects will have no history of cardiovascular or peripheral vascular disease, diabetes, claudication or difficulty walking.

Exclusion Criteria:

1.) Unable to understand the risks, benefits, and alternatives of participation and give meaningful consent, 2.) Contraindications to MRI such (eg implanted metallic objects) 3.) Significant cardiovascular (heart failure, significant coronary artery disease, infiltrative or hypertrophic cardiomyopathy, constrictive pericarditis), pulmonary or musculoskeletal or orthopedic disease that significantly limit exercise capacity 4.) Weight greater than 350 lbs (inability to fit in the MRI), 5.) Cognitive or speech impairments that would limit completion of questionnaires or fatigue reporting. 6) Subjects with rest pain, critical limb ischemia will be excluded for the study. 7) Pregnant women
Efficacy and Safety of GENOSS SES in Patients with Coronary Artery Disease

Efficacy and Safety of GENOSS SES in patients with coronary artery disease

GENOSS SES

Eligibility Criteria:
Inclusion Criteria:

1. Patients of 19 and over
2. Patients with coronary artery disease treated with GENOSS SES
3. Participants who voluntarily decide to participate in this clinical trial, agree to the study protocol and clinical follow-up plan, and provide written informed consent as study participants

Exclusion Criteria:

1. Patients who are contraindicated in the use of heparin, aspirin, clopidogrel, sirolimus, cobalt chromium and contrast agents
2. Patients who are pregnant or planning to become pregnant
3. Patients with a planned surgery to discontinue antiplatelet agents within 12 months
4. Patients with a life expectancy of less than 1 year
5. Patient with cardiogenic shock at the time of hospitalization and had a low chance of survival based on medical judgment.
6. Patients who have already received treatment with another DES (Drug Eluting Stent) or BMS (Bare Metal Stent) at the time of registration
7. Patients participating in randomized controlled trials using other medical devices
The Lymphoma and Leukemia Society Amended COVID-19 Registry

The LLS COVID-19 Registry is being amended to invite people who participated in the LLS COVID-19 Registry and did not develop antibodies after receiving a complete COVID-19 vaccination, as well as people with blood cancer who did not participate in the initial LLS COVID-19 Registry and also did not develop antibodies after receiving a complete COVID-19 vaccination, to participate in this amended LLS COVID-19 Registry.

The results of the Leukemia and Lymphoma Society (LLS) COVID-19 Registry indicate that about twenty-five percent (25%) of people with blood cancer and on immunosuppressants participating in the LLS COVID-19 Registry, who received a complete COVID-19 vaccination, did not develop antibodies.

The Food and Drug Administration has authorized third doses (boosters) of the Pfizer and Moderna Covid-19 vaccines for people with weakened immune systems, in a bid to bolster their protection against infection as the highly contagious Delta variant circulates. The agency will amend the emergency-use authorizations for the two vaccines to allow immunocompromised people to get an additional dose.

Therefore the LLS COVID-19 Registry is being amended to invite people who participated in the LLS COVID-19 Registry and did not develop antibodies as noted above, as well as people with blood cancer who did not participate in the initial LLS COVID-19 Registry and also did not develop antibodies after receiving a complete COVID-19 vaccination, to participate in this amended LLS COVID-19 Registry. Using the same design as the initial COVID-19 Registry (Protocol LLSC19-001), this amended LLS COVID-19 Registry will determine if people who have decided to receive a booster vaccination, who did not develop antibodies after receiving a complete COVID-19 vaccination will develop antibodies after a single dose booster of either the Pfizer or Moderna COVID-19 vaccination.

Eligibility Criteria:
Inclusion Criteria:

* People with blood cancer who did not develop antibodies after a complete COVID-19 vaccination.

Exclusion Criteria:

* People who receiived a complete COVID-19 vaccination and did develop antibodies.
* People unwilling or unable to receive COVID-19 booster.
The Role of GIP in Postprandial Splanchnic Blood Flow Distribution and Metabolism in Patients With Type 2 Diabetes

This project will describe the mechanisms of action and the relative contributions of GIP to changes in gastrointestinal blood flow induced by oral glucose and endogenous GIP with the use of a receptor antagonists GIP(3-30)NH2 in patients with type 2 diabetes.

Each participant will attend four independent randomised experimental days in the MRI-scanner with intravenous infusion (hormone/placebo) and oral ingestion (glucose/water): An intravenous infusion of saline or GIP(3-30)NH2 starts at time point -20 minutes.The infusions are combined with an oral glucose tolerance test (75 gram of glucose dissolved in 250 ml water ingested orally) at time point 0 minutes on two of the experimental days (with and without GIP(3-30)NH2).

MRI measurements are repeatedly performed and blood samples are drawn to be analysed for endocrine responses from the intestines, pancreas, and bones.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* BMI 20-35 kg/m\^2
* Age 20-80

Exclusion Criteria:

* Not MRI-compatible implants
* Claustrophobia
* Abnormal kidney or liver function
* Anemia
* Planned weight loss or change in diet
* Hypertension
* Other conditions that could be expected to affect the primary or secondary outcomes