cyrilzakka/clinical-trials huggingface dataset:
Study of INC280 in Patients With c-MET Dependent Advanced Solid Tumors

This study will assess the safety and efficacy of INC280 in patients with solid tumors that are refractory to current treatment or for which there is not a current standard of care and whose tumors have dysregulation of the c-MET pathway.


Eligibility Criteria:
Inclusion Criteria:

* Must have evidence of c-MET dysregulation from either local data or the results of molecular pre-screening evaluations.
* Confirmed diagnosis of a solid tumor.
* Measureable lesion.
* Refractory to currently available treatment or no therapies available.
* 18 years or older.
* ECOG performance status of 0, 1, or 2.
* Obtained written informed consent.

Additional inclusion criteria for NSCLC patients EGFRwt with high c-MET expression:

* Written documentation of EGFRwt NSCLC.
* Written documentation of c-MET positivity.
* Patients should not have received more than three prior lines of antineoplastic therapy for NSCLC.
* Presence of at least one measurable lesion as determined by modified RECIST version 1.1

Exclusion Criteria:

HCC with liver dysfunction greater than Child-Pugh A. Previous treatment with a c-MET inhibitor or HGF-targeting therapy. Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control their CNS disease.

Any CNS deficits. For patients with GBM, CNS symptoms grade 2 or greater. Subjects with significant or uncontrolled cardiovascular disease (eg, uncontrolled hypertension, peripheral vascular disease, congestive heart failure, cardiac arrhythmia, or acute coronary syndrome) within 6 months of starting study treatment or heart attack within 12 months of starting study treatment.

Receiving anti-epileptic drugs that are known to be strong inducers of CYP3A4. Prior or current anti-angiogenic therapy for patients with GBM. Radiation therapy within ≤ 4 weeks (\< 12 for GBM) prior to the first dose of study drug or limited field radiotherapy within ≤ 2 weeks (\< 12 weeks GBM) prior to the start of study treatment. Any persistent side effect of prior radiotherapy must be resolved to ≤ Grade 1 prior to the first dose of study drug.

Additional exclusion criteria for NSCLC patients EGFRwt with high c-MET expression:

* Patients who have received more than three prior lines of antineoplastic therapies
* Any unresolved toxicity (CTCAE grade \> 1) from previous anti-cancer therapy or radiotherapy, except alopecia
* Patients have received anti-cancer therapies within the following time frames prior to the first dose of study treatment:

  * Conventional cytotoxic chemotherapy: ≤4 weeks (≤6 weeks for nitrosoureas and mitomycin-C)
  * Biologic therapy (e.g., antibodies): ≤4 weeks
  * Non-cytotoxic small molecule therapeutics: ≤5 half-lives or ≤2 weeks (whichever is longer)
  * Other investigational agents: ≤4 weeks
  * Radiation therapy (palliative setting is allowed.): ≤4 weeks
  * Major surgery: ≤2 weeks

Other protocol-defined inclusion/exclusion criteria may apply.
Microcirculatory Changes During Magnesium Sulphate Infusion in Sepsis

During infections (sepsis) bloodflow in small vessels (microcirculation) becomes disturbed. Restoration of bloodpressure and cardiac performance may not be sufficient to correct these alterations. Magnesium is a potent vasodilator which may be used to open up the small vessels, in order to reduce organ failure.

In a single-center open label study we evaluated the effects of magnesium sulphate (MgS) infusion on the sublingual microcirculation perfusion in fluid resuscitated patients with severe sepsis and septic shock within the first 48 hours after ICU admission. Directly prior to and after 1 hour of magnesium sulphate (MgS) infusion (2 gram) systemic hemodynamic variables, sublingual SDF images and standard laboratory tests, were obtained.

Eligibility Criteria:
Inclusion Criteria:

* severe sepsis and septic shock

Exclusion Criteria:

* pregnancy
* oral bleeding
* age \< 18 years
* liver cirrhosis
* acute arrhythmias
* advanced malignancy or a mean arterial pressure (MAP) \< 65 mmHg refractory to vasopressors
A Comparative Study of Tumor Specific Mesocolic Excision and Complete Mesocolic Excision for Right Sided Colon Cancer : Asian Multicenter Retrospective Study

The goal of this observational study is to determine the optimal surgical strategy based on oncologic outcomes in patients with stage I-III right-sided colon cancer who underwent curative right hemicolectomy.

The main question it aims to answer is: Is there a significant difference in 5-year recurrence-free survival (RFS) between patients treated with Complete Mesocolic Excision (CME) and those treated with tumor specific mesocolic excision (TSME)? Participants will include patients who underwent curative right hemicolectomy for right-sided colon cancer between 2015 and 2020 at eight institutions. They will be categorized into two groups based on the surgical technique received-CME group and TSME group-and evaluated for primary and secondary endpoints of 5-year recurrence-free survival (RFS) and overall survival (OS), respectively.

This observational, population-based cohort study was conducted following the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines, with approval obtained from the institutional review board (IRB) of the primary institution and the ethics committees of each participating institution in the Republic of Korea, Hong Kong, and Taiwan. Given that the study utilized anonymized retrospective data, the requirement for informed consent was waived.

The study aimed to evaluate the efficacy and safety of Tumor Specific Mesocolic Excision (TSME) compared to Complete Mesocolic Excision (CME) in patients with right-sided colon cancer. Patients diagnosed with right-sided colon cancer who underwent laparoscopic or robotic right hemicolectomy between 2015 and 2020 were included. Surgical techniques were classified into modified TSME or CME, and the study assessed oncologic outcomes, including recurrence-free survival (RFS), overall survival (OS), lymph node yield, and stage distribution.

Data collection was conducted at multiple medical centers across Asia to ensure a diverse representation of patient demographics and clinical practices. The participating institutions included Asan Medical Center, Korea University Anam Hospital, Severance Hospital, Kyungpook National University Chilgok Hospital, Chinese University of Hong Kong, North District Hospital, Pamela Youde Nethersole Eastern Hospital, and China Medical University Hospital. These centers, varying in location and size, enhance the study's generalizability within the context of right-sided colon cancer management in Asia.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent laparoscopic or robotic right hemicolectomy from 2015 to 2020
* Patients who received curative right hemicolectomy with lymphadenectomy

Exclusion Criteria:

* Familial adenomatous polyposis (FAP)
* Hereditary non-polyposis colon cancer (HNPCC)
* Patients with inflammatory bowel disease
* Patients with synchronous malignancies in other organs
* Patients with non-adenocarcinoma histology of colon cancer
* Patients with follow-up duration of less than 3 months
Beta-Cell Function of Insulin Glargine Compared to Neutral Protamine Hagedorn (NPH) Insuline and to Insulin Detemir in Combination With Metformin

The aim of the study is to show that treatment with Glargine will lead to an improvement in beta cell function especially within times of maximal beta cell stress occurring after a meal. For this reason three different standardized test meals (breakfast, lunch, dinner) will be performed and the postprandial secretion of intact proinsulin levels will be measured. These measurements will be performed with patients treated in combination with metformin and insulin glargine versus metformin plus NPH insulin (within the core study) and if significant difference is observed, with a third treatment arm with metformin plus insulin detemir.

Hypothesis is that the area under the curve (AUC) intact proinsulin levels within 2 hours after test meal dinner of metformin plus insulin glargin differs from AUC intact proinsulin levels of metformin plus NPH insulin.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes mellitus according to the ADA criteria
* HbA1c between 6.5% and 8.5%
* Individually optimized combination therapy with metformin in combination with sulfonylurea in a stable dosage within the last 3 months
* Age between 40 and 75 years
* Fasting intact proinsulin level \> 7 pmol/Land \< 20 pmol/Lat screening

Exclusion Criteria:

* Type 1 Diabetes mellitus
* Pre-Treatment with insulin within the last 3 months prior to screening
* Pre-Treatment with PPARy-agonists (glitazones) within the last 3 months prior to screening
* Major micro- or macrovascular complications as judged by the investigator
* BMI \> 40 kg/m²
* Hypokalemia (K \< 3.5 mmol /L)
* History of drug or alcohol abuse
* Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
* History of severe or multiple allergies
* Treatment with any other investigational drug within 3 months prior to screening
* Progressive fatal disease
* History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT \> 3 times the normal reference range), renal (creatinine \> 1.3 mg/dL in women and \> 1.7 mg/dL in men), neurological, psychiatric and/or haematological disease as judged by the investigator
* Pregnancy or breast feeding
* Sexually active women of childbearing potential not actively and consistently practicing birth control by using a medically accepted device or therapy
A Nutritarian Study to Evaluate the Effectiveness of Lifestyle Changes in Chronic Disease Prevention, Especially Cancer

The Nutritarian Women's Health Study (NWHS) is a long-term hybrid effectiveness-implementation study on the effect of the Nutritarian Diet on the occurrence, recurrence, and progression of chronic diseases (including all forms of cancer and cardiometabolic risk factors).

The Nutritional Research Foundation, in conjunction with Northern Arizona University, is conducting a long-term health study for women ages 18 and older. This study will address the effects of a nutrient dense, plant-rich diet on the long-term risks of cancer and other chronic diseases.

Participants enroll in a 30-day training module which outlines the benefits of a nutrient-dense, plant-rich diet. At the conclusion of those videos and written modules, they take a short quiz to assess their knowledge and they can enroll in the full study.

All participation is online with ongoing modules on nutrition and lifestyle. There is a comprehensive health history and lifestyle index to be completed. Nutrition questionnaires will be administered an average of every 3-6 months; PHQ-9 (Patient Health Questionnaire) \& PSQI (Pittsburgh Sleep Quality Index) questionnaires an average of every 12 months; serum cardiometabolic measures and liquid biopsies an average of every 18 months.

Eligibility Criteria:
Inclusion criteria:

* Women only
* Age 18 years and older.
* Must be willing to complete an online program
* Follow the dietary guidelines as outlined to the best of their ability.
* English-speaking
* US residents
* Have internet access
* Pregnant women are eligible

Exclusion criteria:

* None
Dabrafenib and/or Trametinib Rollover Study

This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.


Eligibility Criteria:
Inclusion Criteria:

* Patient is currently receiving treatment with dabrafenib/trametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective.
* In the opinion of the Investigator would benefit from continued treatment.

Exclusion Criteria:

* Patient has been previously permanently discontinued from study treatment in the parent protocol.
* Patient's indication is commercially available and reimbursed in the local country.
* Patient currently has unresolved toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study.
Xarelto [SPAF-QOL] Post-marketing Surveillance in Japan

The objective of this study is to understand if Rivaroxaban can improve treatment satisfaction of Warfarin patients and assess the safety and effectiveness of Xarelto in real clinical practice.

A total of 725 patients are to be enrolled and followed for a 6 months.period. QOL survey will be conducted at month 0, 3, 6 using ACTS/TSQM.

This study is categorized as a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Xarelto for SPAF.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated by Warfarin for their atrial fibrillation for at least two months at the time of the study initiation.
* Rivaroxaban naïve patients
* Patients 20 years old or older.
* Patients who agree to sign the inform consent

Exclusion Criteria:

* Patients who are contraindicated by product label
Plant Stanol Ester Beverage and Ileostoma Patients

We aim to examine efficacy of a plant stanolester beverage to lower serum cholesterol and LDL-cholesterol levels, when given with or without a fatty acid preparation. Study subjects are otherwise healthy proctocolectomized ileostoma patients (n=10), who consume stanolester beverage with or without a fatty acid preparation in a random order for one week period after a standardized low-fat meal. Washout period is 4 weeks. Serum lipids, lipoprotein lipids, sterols and fecal sterols and variables of cholesterol metabolism will be examined accordingly.


Eligibility Criteria:
Inclusion Criteria:

* healthy proctocolectomized subjects with an ileostoma

Exclusion Criteria:

* Chronic illness
Effectiveness of Two Water-Based Potassium Oxalate Desensitizers on Dental Hypersensitivity

This study will compare the safety and effectiveness of two water-based potassium oxalate desensitizers on existing dentinal hypersensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent to participate in the study
* Be at least 18 years of age
* Be in good general health, as determined by the Investigator/designee based on review of the health history/update for participation in the study
* Agree to refrain from participating in any other oral/dental product studies for the duration of the study
* Agree to refrain from receiving any elective dentistry (including dental prophylaxis) for the duration of the study
* Agree to refrain from using any oral hygiene products other than the assigned study products for the duration of the study
* Agree to comply with study/product usage instructions; and
* Have at least one tooth with gingival recession and hypersensitivity evidenced by a score of ≥ 1 on the Cold Air Sensitivity Schiff scale during screening

Exclusion Criteria:

* Gross oral neglect or urgent dental treatment needs
* Severe periodontal disease and/or generalized mobility
* Active treatment for periodontitis
* Any disease or condition that could be expected to interfere with examination procedures or safe completion of the study
* Self-reported pregnancy or nursing
Intraoperative Mitomycin C in Lacrimal Sac Mucocele

30 patients had lacrimal sac mucocele and dacryocystorhinostomy was done for them with intraoperative mitomycin C was added to decrease postoperative fibrosis and recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Lacrimal sac mucocele

Exclusion Criteria:

* Paediatric patients (less than 16 years old).
* Previous lacrimal passage procedure.
* Neoplasms as secondary causes of obstruction.
Vitamin D Metabolism in Patients With Endocrine Disorders

This prospective controlled interventional study aims to reveal the diversity of vitamin D metabolism in patients with certain endocrine disorders (Cushing's disease, acromegaly, primary hyperparathyroidism, diabetes mellitus type 1) compared to healthy adults. All patients will receive a single dose (150,000 IU) of cholecalciferol aqueous solution orally. Laboratory assessments including serum vitamin D metabolites (25(OH)D3, 25(OH)D2, 1,25(OH)2D3, 3-epi-25(OH)D3, 24,25(OH)2D3 and D3), free 25(OH)D, vitamin D-binding protein (DBP) and parathyroid hormone (PTH) as well as serum and urine biochemical parameters will be performed before the intake and on Days 1, 3 and 7 after the administration.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis (arms "Cushing's Disease", "Acromegaly", "Diabetes Mellitus Type 1", "Primary Hyperparathyroidism")
* active phase of the disease (arms "Cushing's Disease", "Acromegaly")
* no history of surgical and specific pharmacological treatment (arm "Primary Hyperparathyroidism")
* HbA1c \<8.0% (arm "Diabetes Mellitus Type 1")
* absence of the specified endocrine disorders (arm "Control group")

Exclusion Criteria:

* factors associated with vitamin D level

  * intake of the following drugs during the 3 months preceding the study: vitamin D medications; glucocorticosteroids; antiretroviral drugs; antifungal drugs; cholestyramine, orlistat; antiepileptic drugs; antidepressants (fluoxetine); diuretics (spironolactone); antimicrobial agents (macrolides, tetracyclines, isoniazid, rifampin, primaquine); chemotherapy (cyclophosphamide, tamoxifen, paclitaxel, ifosfamide, irinotecan, etoposide, vinblastine); immunosuppressants (cyclosporin A, tacrolimus, sirolimus); H2 receptor antagonists.
  * BMI \>35 kg/m2
  * pregnancy
  * granulomatous disease (sarcoidosis, tuberculosis, histoplasmosis, berylliosis, coccidiomycosis)
  * disease with malabsorption syndrome (Crohn's disease, ulcerative colitis, celiac disease, post-bariatric surgery condition, decompensation of chronic pancreatitis)
  * reduced renal function (eGFR \<60 ml/min/1.73m2)
  * laboratory signs of liver failure (hypoalbuminemia, hypoprothrombinemia)
* hypercalcemia or risk factors for hypercalcemia

  * serum total calcium \>3.0 mmol/L
  * myeloma
  * immobilization
  * thiazide diuretics intake
* allergy to vitamin D drugs
* total 25(ОН)D \>60 ng/ml (determined by chemiluminescent immunoanalysis)
A Trial of Single- and Multiple-doses of Aripiprazole in Adult Subjects With Schizophrenia or Bipolar I Disorder

The primary objective of this trial is to evaluate the pharmacokinetics (PK) of aripiprazole long-acting injectable (LAI) (420 mg) following deltoid or gluteal muscle administration in adult subjects with schizophrenia or bipolar I disorder.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects between 18 and 64 years of age, inclusive.
* Body mass index of 18 to 35 kg/m2, inclusive.
* A current diagnosis of schizophrenia or a current diagnosis of bipolar I disorder as defined by DSM-5 criteria.
* Prior history of tolerating aripiprazole per investigator's judgment.

Exclusion Criteria:

* Subjects who have met DSM-5 criteria for substance dependence within the past 180 days
* Use of any psychotropic medications other than their current non-aripiprazole antipsychotic or mood stabilizer(s) medication or subjects who use more than one antipsychotic or mood stabilizer(s) medication at screening.
* Subjects may not receive varenicline beyond screening.
* Use of any prescription medication not specifically approved by the medical monitor.
* Females who are pregnant or lactating. A negative serum pregnancy test must be confirmed prior to the first dose of IMP for all female subjects.
* Subjects who had participated in any clinical trial involving a psychotropic medication within 1 month prior to enrollment; subjects who had participated in a previous aripiprazole LAI trial within the last 1 year (ie, enrolled but did not receive aripiprazole LAI); or who had previously enrolled and received IMP in an aripiprazole LAI clinical trial.
* Any major surgery within 30 days prior to enrollment or scheduled/elective surgery during the trial.
* Subjects currently in an acute relapse of schizophrenia.
* Subjects with a current DSM-5 diagnosis other than schizophrenia or bipolar I disorder
* Electroconvulsive therapy must not be conducted within 2 months prior to administration of the IMP
* Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia as assessed by the investigator.
* History of or current hepatitis or acquired immunodeficiency syndrome or carriers of HBsAg, anti-HCV, and/or HIV antibodies.
* History of any significant drug allergy or known or suspected hypersensitivity, in particular to aripiprazole or other quinolinones.
* Subjects deemed intolerant of receiving injections.
Effect of Dialysate Temperature on Haemodynamic Stability and Haemodialysis Efficiency

Comparison between dialysate temperatures on haemodynamic stability and haemodialysis efficiency.

Comparison of 4 different dialysate temperatures for haemodialysis of patients with chronic renal failure.

Comparison of 3 different dialysate temperatures for haemodialysis of patients with acute renal failure.

Investigation of the efficiency of haemodialysis of patients with acute renal failure

Eligibility Criteria:
Inclusion Criteria:

* Chronic renal failure
* Acute renal failure
* Aged between 21-90 years

Exclusion Criteria:

-
Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults

The purpose of this study is to determine whether a combination of a radiochemotherapy (vincristin) and a following maintenance chemotherapy (vincristin, cisplatin and CCNU) in adult patients with medulloblastoma is tolerable.

As medulloblastoma in adult patients are very rare (1.1% of all brain tumors), adults are often treated in the scope of expanded access treatments or within pediatric studies; although, it is not known whether medulloblastomas act in the same way in adulthood and in childhood. This is the first study to investigate the significance of a combination of a radiochemotherapy (vincristin) and a following maintenance chemotherapy (vincristin, cisplatin and CCNU) in adult patients with medulloblastoma with the purpose to have a starting point for the development of chemotherapeutical protocols in adults.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* medulloblastoma (+/- postoperative residual tumor, M0) or medulloblastoma (+/- postoperative residual tumor, M1-M3) respectively
* primary diagnosis of the tumor
* no previous chemo- or radiation therapy
* Karnofsky-Index ≥ 70%
* WBC ≥ 3000/μl; thrombocytes ≥ 100 000/μl; Hb ≥ 10 g/dl
* creatinine =\< 1,5 ULN; Bilirubin =\< 1,5 ULN; GPT, GOT, AP =\< 2,5 ULN
* HIV and hepatitis B/C negative
* no factors / any medical condition affecting patient's compliance
* patient needs to fulfil protocol's requirements
* patient is willing to use highly effective methods of contraception during dosing and for 6 months after the last dose; women of child-bearing potential must have a negative hCG laboratory test at baseline; pregnancy tests must be repeated every 4 weeks
* patient's written consent

Exclusion Criteria:

* age \< 18 years
* histologically not confirmed Medulloblastoma
* by chemo- or radiotherapy treated recidive tumor
* other cancer (with exception of surgically cured carcinoma in situ of the cervix and non-melanocytic skin tumors)
* hypersensitivity or contraindication against one of the used drugs
* current or planned participation to another clinical trial during this study Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrolment or could interfere with the patient participating in and completing the study
* Any medical condition associated with high medical risk or contraindicated to use chemotherapeutic agents as indicated in current product package insert
* Pregnant or nursing (lactating) women; women or men not willing to use a highly effective methods of contraception