cyrilzakka/clinical-trials huggingface dataset:
Open-Label, Multicenter Extension Study for Patients Completing Treatment Phase of a Rigel-Sponsored R935788 Studies

The purpose of this new research study is to gain additional information about how safe and effective R935788 is over a longer period of time.


Eligibility Criteria:
Inclusion Criteria:

* Patients must give written informed consent by signing an IRB/EC-approved Informed Consent Form (ICF) prior to admission to this study
* Patients who are being treated in Study C-788-006X
* Patients who completed Studies C-788-010 or C-788-011 and did not withdraw due to adverse events
* Patients who withdrew from Study C-788-010 at Month 4 or Month 5 because of a pre-defined lack of efficacy
* Females of childbearing potential must be fully informed of the potential for R788 to adversely affect the fetus and, if sexually active, must agree to use a well established method of birth control during the study (oral contraceptive, mechanical barrier, long acting hormonal agent). These patients must not be lactating and must have a negative pregnancy test at the time of entry and at each laboratory determination.

Exclusion Criteria:

* The patient has a history of, or a concurrent, clinically significant illness, medical condition (other than arthritis) or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study. Specifically, excluded are patients with the following:

  1. unresolved Grade 2 or greater toxicity in a RA protocol studying R788
  2. uncontrolled or poorly controlled hypertension;
  3. recent (within past 2 months) serious surgery or infectious disease;
  4. recent history (since enrollment in prior R788 study) of, or treatment for, a malignancy other than non-melanomatous skin cancer, or any history of lymphoma;
  5. known to be positive for Hepatitis B, Hepatitis C, HIV or Tuberculosis;
  6. interstitial pneumonitis or active pulmonary infection;
  7. known laboratory abnormalities: ALT \> 1.2 x ULN, creatinine \>1.5x ULN, an ANC \<2,500/mm3 or 2.5 x 109/L, lymphocyte count \< 600/mm3 or 0.6 x 109L, Hgb \< 9 g/dL or 5 mmol/L, platelet count \<125,000/mm3 or 125 x 109/L are excluded.
* The patient has a history of substance abuse, drug addiction or alcoholism. Patients may consume up to 4 units of alcohol per week; however, alcohol should be avoided in the 72 hours prior to lab assessments. Patients who cannot reliably comply with this should be excluded. A unit of alcohol is defined as the following: Beer = 12 oz or 355 mL; wine = 5 oz or 148 mL; sweet dessert wine = 3 oz or 89 mL; 80 proof distilled spirits = 1.5 oz or 44 mL.
* The patient is unable to report for clinical and laboratory monitoring as per protocol.
Induction Chemotherapy,Radiochemotherapy, Consolidation Chemotherapy in Preoperative Treatment of Rectal Cancer

The use of capecitabine based preoperative chemoradiation and adjuvant chemotherapy is standard treatment of locally advanced rectal cancer. It has reduced local recurrence rate to less than 10%, but has only had limited effect on overall survival due to the constantly high (more than 30%) rate of distant metastasis.

Complete eradication of the primary tumour observed in the histopathological specimen (pathological complete response, pCR) correlates with a favourable overall prognosis so obtaining a pCR might be beneficial. The aim of the study is to investigate whether the addition of capecitabine based chemotherapy before preoperative chemoradiation and also before the operation improves pathological complete remission rate in locally advanced rectal cancer with acceptable toxicity. Secondary objectives are to evaluate pathological downstaging rate, histopathological R0 resection rate,sphincter preservation rate, perioperative surgical complication rate, local control, DFS, OS, late toxicity and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with histologically proven adenocarcinoma of the rectum (tumour located below the peritoneum),
* T3/4 or any node positive disease (clinical stage according the TNM classification system)
* No evidence of metastatic disease.
* The disease must be considered either resectable at the time of entry or thought to become resectable after preoperative chemoradiation.
* Age 18 years and more
* WHO Performance Status 0-2
* No prior radiotherapy, chemotherapy or any targeting therapy for rectal cancer
* Adequate hematological, hepatic and renal function Ability to swallow tablets
* Signed informed consent
* Patients must be willing and able to comply with the protocol for duration of the study

Exclusion Criteria:

* Malignancy of the rectum other than adenocarcinoma
* Any unrested synchronous colon cancer
* Other co-existing malignancy or malignancy within the past 5 years, with the exception of adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin
* Significant heart disease (uncontrolled hypertension despite of medication (\> 150/100 mmHg), NYHA class III or IV heart disease,unstable angina or myocardial infarction within the past 1 year prior the study entry, history of significant ventricular arrhythmia requiring treatment)
* Pregnant or lactating patient
* Females with a positive or no pregnancy test unless childbearing potential can be otherwise excluded (amenorrheic for at least 2 years,hysterectomy or oophorectomy)
A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo

The purpose of this study will be to examine the efficacy, safety, and tolerability of ruxolitinib cream in subjects with vitiligo.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of vitiligo.
* Vitiligo with depigmented areas including:

  * at least 0.5% of the total body surface area (BSA) on the face (0.5% BSA is approximately equal to the area of the participant's palm \[without digits\]) AND
  * at least 3% of the total BSA on nonfacial areas (3% BSA is approximately equal to the area of 3 of the participant's handprints \[palm plus 5 digits\]).
* Participants who agree to discontinue all agents used to treat vitiligo from screening through the final follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.

Exclusion Criteria:

* Conditions at baseline that would interfere with evaluation of vitiligo.
* Participants who are receiving any kind of phototherapy, including tanning beds.
* Participants with other dermatologic disease besides vitiligo whose presence or treatments could complicate the assessment of repigmentation.
* Participants who have used skin bleaching treatments for past treatment of vitiligo or other pigmented areas.
* Participants who have received any of the following treatments within the minimum specified timeframes.

  * Use of any biologic, investigational, or experimental therapy or procedure for vitiligo within 12 weeks or 5 half-lives (whichever is longer) of screening.
  * Use of laser or light-based vitiligo treatments, including tanning beds, within 8 weeks of screening.
  * Use of immunomodulating oral or systemic medications (eg, corticosteroids, methotrexate, cyclosporine) or topical treatments that may affect vitiligo (eg, corticosteroids, tacrolimus/pimecrolimus, retinoids) within 4 weeks of screening.
* Use of any prior and concomitant therapy not listed above that may interfere with the objective of the study as per discretion of the investigator, including drugs that cause photosensitivity or skin pigmentation (eg, antibiotics such as tetracyclines, antifungals) within 8 weeks of screening.
* Participants with a clinically significant abnormal thyroid-stimulating hormone or free T4 at screening.
* Participants with protocol-defined cytopenias at screening
* Participants with severely impaired liver function.
* Participants with impaired renal function.
* Participants taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit.
* Participants who have previously received JAK inhibitor therapy, systemic or topical.
Development and Evaluation of HighAlert

In Canada, youth ages 16-24 have the highest rates of cannabis use, impaired driving, and express the least concern for driving under the influence of cannabis (DUIC). As such, developing effective and practical DUIC prevention efforts is crucial. This study aims to evaluate the effects of 'High Alert' in reducing 3-month risky cannabis use and DUIC among young Ontarian drivers. 'High Alert' is an interactive web-based smartphone application developed by the research team with the feedback of experts and youth. 'High Alert' modules focus on recognizing what constitutes risky cannabis use, the effects of cannabis on driving, the risks of DUIC, and strategies to avoid DUIC. A pilot randomized controlled trial will compare the effects of 'High Alert' with an active control (DUIC Information) and passive control (no contact). Overall, effectively preventing DUIC among youth is critically needed and time-sensitive.


Eligibility Criteria:
Inclusion:

* ages 18-24
* valid Ontario driver's license
* access to a motor vehicle
* report DUIC at least three times in the past three months
* proficient in English
* have a smartphone they can complete the intervention with.

Exclusion Criteria:

* Individuals under 18 and those over 24
* resides outside Ontario
* non-drivers
Trial for Evaluation of Safety of Escalating Dose Levels of MEDI-507 in Patients for Treatment of at Least Grade II Graft-Versus-Host Disease (GvHD)

A trial to assess safety of four doses of MEDI 507 combined with another drug for initial treatment of at least Grade II acute Graft-vs-Host Disease in recipients.

The primary objective of this study is to assess safety of four dose levels of MEDI 507 combined with methylprednisolone for initial treatment of at least Grade II acute GvHD in stem cell or bone marrow allograft recipients.

Eligibility Criteria:
Inclusion Criteria:

1. allogeneic bone marrow or hematopoietic stem cell graft recipients
2. acute GvHD of at least Grade II severity
3. receipt of at least 2 mg/kg of methylprednisolone (or equivalent corticosteroid) within eight to 24 hours prior to initial receipt of study drug
4. evidence of engraftment (ANC over 1,000 cells/mm3)
5. histologic evidence of GvHD from biopsy performed during the current episode
6. receipt of GvHD prophylaxis of methotrexate, tacrolimus or cyclosporine
7. age at least 18 years
8. body weight under 130 kg
9. Both males and females are eligible, but females of childbearing potential, unless previously surgically sterilized, agree to use an effective method of birth control (e.g., abstinence, intrauterine contraceptive device, oral contraceptives, diaphragm or condom in combination with contraceptive jelly, cream or foam, Norplant7 or DepoProvera7) beginning with the first study injection and continuing through 60 days after the final study injection.

Exclusion Criteria:

1. previous receipt of MEDI 507
2. diagnosis of chronic GvHD
3. previous treatment with any anti-T-cell monoclonal antibodies such as OKT73 or daclizumab (Zenapax7)
4. receipt of antithymocyte globulin (ATGAM7 or other ATG) within 14 days
5. treatment with more than 0.3 mg/kg/day of methylprednisolone (or equivalent corticosteroid) for more than 72 hours for the treatment of GvHD
6. intolerance or history of intolerance to corticosteroids such that it is unlikely the patient will be able to complete at least ten days of corticosteroid therapy (2 mg/kg/day of methylprednisolone or equivalent)
7. more than one allogeneic bone marrow or hematopoietic stem cell allograft
DASH Cloud: Using Digital Health to Improve Adherence to the DASH Diet Among Women

This study will test whether a digital health intervention (DASH Cloud) using smartphones can improve diet quality among women at risk for cardiovascular disease. The DASH (Dietary Approaches to Stop Hypertension) Diet has been proven to lower blood pressure, yet dissemination efforts remain poor. This study aims to use technology to improve adherence to DASH.

Specifically, this study aims to

1. To test the feasibility of the DASH Cloud intervention compared to education control among women with prehypertension and hypertension via a 3-month randomized controlled trial.
2. To evaluate the preliminary efficacy of the DASH Cloud intervention relative to education control on blood pressure, weight and medication adherence at 3 months.

This study will enroll 50 adult women aged 21-70 with pre-hypertension or hypertension in a 3-month randomized controlled trial to test the initial feasibility of DASH Cloud. Women will be randomized to either the DASH Cloud intervention or DASH Light and followed up 3 months post randomization. The investigators will recruit participants from the Durham, NC area.

Women randomized to the DASH Cloud intervention will be asked to track their diet daily using a smartphone diet tracking app. Based on the foods/beverages entered, the intervention will send daily or weekly text messages with feedback about DASH adherence and information videos about how to follow DASH. Women randomized to DASH Light will also be asked to track their diet using the smartphone diet tracking app and will receive basic informational materials about DASH.

Eligibility Criteria:
Inclusion Criteria:

* ages 21-70 years; BMI \>18.5 kg/m2
* on antihypertensive medication or systolic blood pressure 120-159 mmHg and/or diastolic blood pressure of 80-99
* current use of a smartphone and willingness to be texted daily or weekly
* an email account; spoken and written English fluency.

Exclusion Criteria:

* CVD event in prior 6 months
* active malignancy; active psychosis or recent psychiatric institutionalization
* current pregnancy or lactation
* current participation in a similar trial.
Comprehensive Treatment for Different Types of Tumor Thrombi in the Portal Vein for Hepatocellular Carcinoma Patients

This study is working to evaluate the surgical comprehensive treatment for different types of tumor thrombi in the portal vein for hepatocellular carcinoma patients, to establish a standardized, unified, effective therapeutic program.

Primary liver cancer (PLC) has a great tendency to invade portal vein intravascularly, results in the formation of portal vein tumor thrombus (PVTT), which is a crucial factor that can worsen the prognosis of patients with PLC.

In clinical, various treatments have been applied to improve this short-term prognosis, but there was no identical indication for treatment of PLC patients with different PVTT.

The objective of this study is to evaluate the surgical comprehensive treatment for different types of tumor thrombi in the portal vein for hepatocellular carcinoma patients, to establish a standardized, unified, effective therapeutic program.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients \> 30 years and \<=60 years of age.
* with a clinical diagnosis of primary liver cancer with PVTT, without any adjuvant therapy.
* resectable tumors in the liver.
* PVTT type for II or III (based on the PVTT type system established by our groups), confirmed through pre-operative imaging and pathologic examination.
* liver function grade A or B of the Child-Pugh classification.
* No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal. Hb ≥95g/L,WBC ≥3.000 cells/mm³,platelets ≥80.000 cells/mm³.
* Patients who can understand this trial and have signed information consent.

Exclusion Criteria:

* have had an allergic reaction following iodine or chemotherapeutic drugs.
* with extrahepatic metastasis.
* Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.
* liver function:Child C.
Study to Explore the Effect of Mefloquine in Participants With Progressive Multifocal Leukoencephalopathy (PML)

The primary objective of the study was to explore whether mefloquine can delay or stop progression of progressive multifocal leukoencephalopathy (PML) as measured by JC virus (human polyomavirus or JCV) deoxyribonucleic acid (DNA) levels in cerebrospinal fluid (CSF). The secondary objective of the study was to explore whether mefloquine can delay or stop progression of PML based on neurological deterioration, magnetic resonance imaging (MRI) measures of brain lesion evolution or the formation of new lesions, and mortality.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of PML confirmed by detection of JCV DNA in CSF.
* Onset of PML symptoms within 6 months prior to study.

Key Exclusion Criteria:

* Other opportunistic infection of the central nervous system.
* Current severe illness or any other conditions that, in the opinion of the Investigator, would make the subject unsuitable for enrollment.
* Active severe mental illness (e.g., depression, anxiety, psychosis, and schizophrenia).
* Hypersensitivity to mefloquine, quinine, or quinidine, or to any component of these drugs.
* Current treatment with quinine, quinidine, chloroquine, or halofantrine.

Note: Other protocol-defined criteria may also apply.
Research Study Investigating How Well Semaglutide Works in People From Thailand and South Korea Living With Obesity

This study looks at how well semaglutide helps people lose weight. This study will look at the change in the participants' body weight from the start to the end of the study. The study compares the weight loss in people who get semaglutide to the weight loss in people who get placebo. Placebo is a "dummy" medicine that looks like the study medicine, but has no effect on the body.

Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm.

Participants will also have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight.

The study will last for about a year (50 weeks). Participants will have 10 clinic visits and 8 phone calls. At 6 of the clinic visits participants will have blood samples taken.

Participants cannot take part if participants have or have had diabetes. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.


Eligibility Criteria:
Inclusion Criteria:

* Age above or equal to 18 years at the time of signing informed consent.
* BMI at least 25.0 kg/m\^2 at screening.
* Both parents of Asian descent.
* History of at least one self-reported unsuccessful dietary effort to lose body weight.

Exclusion Criteria:

* HbA1c at least 48 mmol/mol (6.5%) as measured by the central laboratory at screening.
* History of type 1 or type 2 diabetes mellitus.
* A self-reported change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records.
* Any participant where a substantial weight loss, in the investigator's opinion, might jeopardise the participant's safety.
* Renal impairment with estimated Glomerular Filtration Rate (eGFR) below 15 mL/min/1.73 m\^2 at screening.
Predicting Response to Chemotherapy in Colorectal Cancer Via Multi-dimensional Analyses of the Tumor Associated Neutrophils

A single biomarker is not adequate to identify patients with colorectal cancer (CRC) who have the potential to benefit from adjuvant therapy, presumably owing to the complexity of tumor-infiltrating immune cells (TIICs). The density and spatial organization of TIICs has not been definitely established to explore their predictive value. This study aimed to investigate the prognostic significance of TIICs and its biological predictive value in CRC.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily sign a written ICF.
2. The Eastern Cancer Collaborative Organization (ECOG) has a physical fitness score of 0 or 1.
3. The expected survival period is ≥ 3 months.

5. Subjects diagnosed with metastatic colorectal adenocarcinoma by histology or cytology.

6. Colorectal cancer patients who have not received systematic anti-tumor therapy in the past.

Exclusion Criteria:

1. Subjects suffered from other malignant tumors within 3 years before enrollment, except for cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, etc.).
2. Simultaneously enroll in another clinical study, unless it is an observational, non-interference clinical study or a follow-up period of an intervention study.
3. Received systematic anti-tumor therapy (chemotherapy) within 3 weeks prior to the first administration
Comparison of Systemic Response After Laparoscopies Performed With Standard and Low-Pressure Pneumoperitoneum

The purpose of the study was the comparative assessment of the influence of low and standard pressure CO2 pneumoperitoneum on the systemic inflammatory and angiogenic responses during the postoperative period after laparoscopic management of cholelithiasis.

Objective: The purpose of the study was to access the influence of low pressure CO2 pneumoperitoneum on the inflammatory and angiogenic responses during the postoperative period after laparoscopy. Summary background data: Surgical procedures enhance production of pro- and anti-inflammatory cytokines and angiogenic factors that play a pivotal role in the immunological response to surgical trauma and take part in the pathogenesis of tumor growth and adhesions formation. Methods: Study group consisted of 40 patients, operated on due to cholelithiasis using standard- (n=20) and low-pressure (n=20) CO2 pneumoperitoneum. Serum concentration of IL-6, IL-8, IL-10, VEGF-A and endostatin were measured before the surgeries and thereafter at 6, 24 and 48h with commercially available ELISA assays. Results: Concentrations of IL-6 increased significantly after the operations in both groups. No differences were observed between the groups in regards to IL-6, IL-8 and IL-10 levels. Concentrations of VEGF-A measured at 6 and 48h were significantly lower in patients who underwent laparoscopies performed with low pressure pneumoperitoneum. No significant variations were observed in endostatin serum concentration. Concentrations of the studied parameters were not influenced by the duration of surgeries, age, gender, or BMI of the patients. Conclusions: The results obtained in our study do not show any significant differences between studied operative procedures with regards to systemic inflammatory response. Changes in the concentrations of VEGF-A and endostatin observed in the studied population may suggest this technique to be more favorable with regards to angiogenesis process intensity, along with all its consequences and implications.

Eligibility Criteria:
Inclusion Criteria:

* cholelithiasis

Exclusion Criteria:

* symptoms of acute cholecystitis, diabetes, body mass indx above 36 kg/m2 and autoimmunological diseases.