cyrilzakka/clinical-trials huggingface dataset:
Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have recurrent or progressive malignant glioma.

OBJECTIVES:

* Determine the progression-free survival and response rate of patients with recurrent or progressive malignant glioma treated with temozolomide.
* Determine whether certain categories of malignant gliomas, such as oligodendroglioma, are more sensitive to temozolomide.
* Determine the toxicity of this regimen in these patients.

OUTLINE: Patients are stratified according to histologic categories (recurrent glioblastoma multiforme \[closed to accrual 11/30/01\] vs recurrent anaplastic astrocytoma vs recurrent anaplastic oligodendroglioma).

Patients receive oral temozolomide twice daily for 5 consecutive days. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven recurrent or progressive malignant glioma of one of the following types:

  * Anaplastic oligodendroglioma or oligoastrocytoma
  * Anaplastic astrocytoma
  * Glioblastoma multiforme (stratum closed to accrual 11/30/01)
* Patients who have failed radiotherapy are eligible
* Measurable disease by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 70-100%

Life expectancy:

* At least 12 weeks

Hematopoietic:

* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin greater than 10 g/dL

Hepatic:

* SGOT or SGPT less than 3 times upper limit of normal (ULN)
* Alkaline phosphatase less than 2 times ULN (if greater than 2 times ULN then a gamma glutamyl transferase test must be performed)

Renal:

* BUN less than 1.5 times ULN
* Creatinine less than 1.5 times ULN

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception
* No other serious concurrent infection or other medical illness that would preclude study entry
* No frequent vomiting or partial bowel obstruction
* HIV negative
* No AIDS-related illness
* No other concurrent malignancy except carcinoma in situ of the cervix or basal cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No concurrent epoetin alfa

Chemotherapy:

* At least 6 weeks since other prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics
* At least 3 months since prior radiotherapy (exceptions allowed for recurrent/progressive disease at discretion of primary investigator)

Surgery:

* Recovered from prior surgery

Other:

* No other concurrent investigational agents
* Concurrent anticonvulsant therapy allowed
A Study of the Cardiac Effects of ALXN2050 in Healthy Adults

This is a randomized, double-blind, double-dummy, placebo- and positive-controlled parallel study to evaluate the effect of ALXN2050 on the QT interval in healthy adult participants.

Participants randomized to the treatment arm will receive ALXN2050 in a multiple-ascending doses fashion over 3 periods (treatment sequence ABC). Participants randomized to the control arms will be further randomized to 1 of 2 treatment sequences (treatment sequence DEF or GHI) to receive placebo or active control over 3 periods.

Eligibility Criteria:
Inclusion Criteria:

1. Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at screening.
2. No clinically significant history or presence of ECG abnormalities at screening.
3. Female participants must be of non-childbearing potential and need not employ a method of contraception.
4. Non-sterile male participants must agree to abstinence or use a highly effective method of contraception.

Exclusion Criteria:

1. Clinically significant laboratory abnormalities.
2. History of any medical or psychiatric condition or disease that might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
3. History or presence of drug or alcohol abuse within previous 2 years, current tobacco and/or nicotine user, or positive alcohol and/or drug screen at screening or Day -1 of Period 1.
4. History or presence of clinically significant seizures, head injury, or head trauma.
5. History of procedures that could alter absorption or excretion of orally administered drugs.
6. History of meningococcal infection, or a first-degree relative with a history of meningococcal infection.
7. History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs.
8. Body temperature ≥ 38.0°Celsius at screening or prior to first dosing in Period 1 or history of febrile illness, or other evidence of infection, within 14 days prior to (first) dosing.
9. Donation of whole blood from 3 months prior to first dosing, or of plasma from 30 days before first dosing, or receipt of blood products within 6 months prior to first dosing.
10. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives (if known) or 30 days before first dosing, whichever is longer.
The GRK2 Inhibitor Paroxetine as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients

Among three MAPK families, paroxetine was found to be able to decrease the phosphorylation of ERK. It was reported that paroxetine attenuates the symptoms of collage induced arthritis rats due to its inhibitory effect on T cell activation and infiltration to synovial tissue via suppression of ERK pathway. This study aimed to evaluate the therapeutic efficacy of paroxetine in rheumatoid arthritis. Paroxetine prevents the joint inflammation which is at the very early stage. paroxetine could inhibit GRK2 with selectivity over other GRKs. Medications developed for maintaining the immunologic equilibrium. such as GRK2 inhibitors, will be the novel trends in RA treatment that could avoid the adverse side effects that are common with current treatment options.


Eligibility Criteria:
Inclusion Criteria:

• Patients with active rheumatoid arthritis based on DAS28 score. Patients received the standard therapy (i.e. one or more conventional DMARDs) for at least three months.

Exclusion Criteria:

* Known hypersensitivity to metformin.
* Patients who have a prior diagnosis with diabetes mellitus.
* Patients receive metformin for any other indications.
* Patients with congestive heart failure.
* Patients with a history of myocardial infarction.
* Patients with severe anemia.
* Patients with active infections or other inflammatory diseases.
* Patients receiving biological therapy.
* Pregnancy or lactation.
* Patients with impaired liver functions.
* Patients with impaired kidney functions (serum creatinine concentrations ≥1.5 and ≥1.4 mg/dL in males and females respectively).
* Patients with malignancies.
Lactobacillus Lozenges as Preventative Care in Low-grade Dysplasia

There are limited evidence-based management options for patients with low-grade oral dysplasia. Despite the risk of malignant transformation, management is frequently limited to risk factor reduction (such as smoking cessation) and clinical surveillance. An intervention for low-grade oral dysplasia which could induce regression or decrease rates of malignant transformation has the potential to be a valuable preventative tool to reduce rates of oral cancer.

The investigators will conduct a randomized clinical trial to investigate if the administration of a probiotic lozenge to patients with low-grade oral dysplasia result in decreased peri-tumoral inflammation as evidenced by impacts on populations of tumor-associated macrophages and tumor-infiltrating lymphocytes, and decreased dysbiosis at the disease site compared with the contralateral normal site. The investigators hypothesize that these changes may increase the rate of clinical regression of these lesions.


Eligibility Criteria:
Inclusion Criteria:

* Presence of biopsy-proven low-grade or mild oral dysplasia

Exclusion Criteria:

* Active oral cavity malignancy
* Active oral cavity high grade dysplasia
* Currently undergoing chemotherapy or immunotherapy, or have used these agents within the prior 6 months
* History of external beam radiation therapy to the head and neck area
* Diagnosis of HIV with decreased CD4 count and/or detectable viral load
* Current use of systemic or orally absorbed steroids
* Patient undergoing stem cell transplantation
* Patients taking anti-rejection medication after stem cell or solid organ transplantation
* Patients using injectable immunosuppressive drugs for autoimmune disease
* Pregnant or nursing women
* Patients who are hospitalized
* Patients with a heart valve abnormalities or a history of valve replacement or endocarditis
* Patients with active severe acute intestinal disease (active bowel leak, acute abdomen, active colitis) or a history of short bowel syndrome
Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device in the Treatment of Bipolar Depression

This study is evaluating the potential antidepressive effect of a 4 week treatment protocol using the H-coil deep TMS device in bipolar depression.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bipolar depression

Exclusion Criteria:

* No other axis I disorder
* Risk factors for convulsions
Investigation of TEST (Transcranial Electric Stimulation Therapy) for Chronic Pain

The goal in this study is to investigate TEST (Transcranial Electric Stimulation Therapy) for chronic pain. It requires an inpatient stay on our research unit of about a month. The study is designed to address the cognitive and emotional aspects of chronic pain and other conditions that often accompany this disorder, such as major depression or drug use.

This project proposes to investigate the feasibility of TEST in subjects with chronic pain. This will be an open-label study where subjects (n=12) are administered 8-10 sessions of TEST over 4 weeks. Measurements of pain, mood, and memory will be obtained before and after the sessions. The hypothesis is that TEST will be feasible and tolerable in this population.

Eligibility Criteria:
Inclusion Criteria:

1. adults (ages 22 to 60) who understand all procedures and have the ability to provide informed consent, with a score on the Mini-Mental Status Exam of at least 24;
2. participants experiencing chronic pain, with ongoing pain symptoms, and score on the Brief Pain Inventory of \> 5 on question #3 (which asks about maximal pain in the past 24 hours) or \> 5 on question #5 (which asks about average pain in the past 24 hours);
3. a diagnosis of chronic postoperative pain, low back pain, musculoskeletal pain, fibromyalgia, visceral pain or neuropathic pain, including complex regional pain syndrome or peripheral neuropathy;
4. no significant changes in pain medications for at least one month prior to study entry.
Effects of Hepatic Fibrosis on Hepatic Steatosis Using the Ultrasound Attenuation Imaging in Chronic Hepatitis B

The investigator aimed to prospectively study the effect of the hepatic fibrosis on quantifying hepatic steatosis using ultrasound attenuation imaging (ATI value) in patients with chronic hepatitis B.

Chronic hepatitis B virus (HBV) infection has been reported to be associated with the prevalence of non-alcoholic fatty liver disease (NAFLD). Prior studies demonstrate that concurrent fatty liver increases risk of hepatocellular carcinoma among patients with chronic hepatitis B. Therefore, quantification of hepatic steatosis and fibrosis in chronic hepatitis B patient has important clinical significance in active surveillance.

Ultrasound imaging provides reliable noninvasive quantification of hepatic steatosis and fibrosis. Attenuation imaging (ATI) reflects hepatic steatosis and 2D-shear wave elastography reflects hepatic fibrosis.

The potential interaction between of the hepatic fibrosis and the hepatic steatosis in chronic hepatitis B is not fully understood. The investigator investigated the effect of the hepatic fibrosis on quantifying hepatic steatosis using ultrasound attenuation imaging (ATI value) in patients with chronic hepatitis B.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis B patients
* Who is scheduled for pathological exam such as liver biopsy or surgery, that can quantify hepatic steatosis and hepatic fibrosis
* Who submitted informed consent

Exclusion Criteria:

* Who underwent liver transplantation or right hemihepatectomy
* Huge hepatic mass or numerous cysts in right hepatic lobe, who is not eligible for measuring ultrasound attenuation imaging and Fibroscan
* High bleeding risk patients
Primary Connections for Youth and Families

The goal of this clinical trial is to compare a standard adolescent-only approach to substance use screening, brief intervention, and referral to treatment to a in primary care settings. Primary outcomes (AOD use, co-occurring behavior problems, parent-youth communication about AOD use) and secondary outcomes (adolescent quality of life, therapy attendance) are assessed at screen/initial and 3, 6, 9, and 12 months follow-up.

This randomized effectiveness trial compares a standard adolescent-only approach (SBIRT-A-Standard) versus a family-based approach (SBIRT-A-Family) in which caregivers are systematically included in screening, intervention, and referral activities. The study includes N = 2,300 adolescents (age 12 - 17) and their caregivers attending one of three hospital-affiliated pediatric settings serving diverse patients in major urban areas. Study recruitment, initial screening, randomization, and all SBIRT-A activities occur during a single pediatric visit. SBIRT-A procedures are delivered primarily in digital format on hand-held tablets using both patient-facing and provider-facing programming. Primary outcomes (AOD use, co-occurring behavior problems, parent-youth communication about AOD use) and secondary outcomes (adolescent quality of life, therapy attendance) are assessed at screen/initial and 3, 6, 9, and 12 months follow-up. The study is well powered to conduct all planned main and moderator (age, sex, race/ethnicity, youth AOD risk status) analyses.

Eligibility Criteria:
Inclusion Criteria:

* Youth aged 12-17 years with a primary caregiver (i.e., parental figure) also in attendance to primary care appointment
* Youth and caregiver are fluent in English or Spanish
* Youth and caregiver are capable of using audio-assisted informed consent procedures and independently operating a hand-held tablet device
* Youth and caregiver are complete routine site AOD risk screening questions prompted during PC visit intake
Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia

This pilot study seeks to evaluate the safety, acceptability and feasibility of a shortened outpatient procedure for medical abortion at 13-18 weeks gestation. It also seeks to document the roles of health workers in providing services related to later abortion care. Participants will take a single dose of 200 mg mifepristone orally, followed 24-48 hours later with 400 mcg misoprostol sublingually prior to arriving at the study clinic. Repeat doses of 400 mcg misoprostol will be administered sublingually every three hours at the clinic until the abortion is achieved. If expulsion does not occur by a certain time prior to the clinic closing that day, D\&E will be performed to complete the abortion.


Eligibility Criteria:
Inclusion Criteria:

1. Have an intrauterine pregnancy of 13-18 weeks gestation according to ultrasound
2. Meet legal criteria to obtain abortion
3. Be at least 18 years old
4. Have access to a phone where she can be reached for the 2-week follow up
5. Be willing to follow pilot study procedures

Exclusion Criteria:

1. Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
2. Any contraindications to vaginal delivery
3. More than one prior cesarean delivery
4. Staying more than 2 hours away from the clinic
Effect of Post-exercise Nutrition on Glycemia in Women

The purpose of this study is to assess whether post-exercise Greek yogurt following a single session of aerobic exercise improves metabolic and musculoskeletal health in women with overweight/obesity.

Following the acquisition of informed consent, eligibility to participate in the study will be determined using questionnaires. Participants will undergo baseline testing at our laboratory at the University of Toronto to determine cardiorespiratory fitness, body composition and undergo exercise familiarization.

Eligible participants will be assigned, in a random order, to two metabolic trials approximately 4 weeks apart that involve 4 days of controlled diet and exercise. Each trial takes place over 4 days, but participants are not required to come to the laboratory on all days. The two trials involve: 1) Exercise + Greek Yogurt (GY) 2) Exercise + a carbohydrate-based study supplement (SS).

During the 4 day trials, participants consume controlled diets and the study supplements (GY and SS). On 1 of these days participants will perform exercise in our lab followed by the consumption of GY or SS. Various outcomes will be measured throughout the trial, including glycemic control (via continuous glucose monitoring), fat oxidation, appetite and health outcomes in blood samples.

Throughout the duration of the study, participants will be asked to maintain their habitual diet and physical activity patterns, and maintain their current body weight.

Eligibility Criteria:
Inclusion Criteria:

* 18-45 yrs
* BMI ≥27 kg/m2
* Elevated waist circumference (≥88 cm)
* ≤2 structured exercise sessions/week
* Weight stable (within ± 2kg for at least 6 months)
* Experiencing regular natural menstrual cycles
* Non-smoker

Exclusion Criteria:

* Allergy to dairy foods
* Diagnosed lactose intolerance or an aversion to foods provided during the study (e.g., post-exercise snacks)
* Previous history of cardiovascular or metabolic disease
* The use of medication for managing blood glucose or lipid metabolism
* Current use of oral contraceptives or use within the last 3 months
* Irregular menstrual cycles (\<21 days or \>35 days)
* Pregnant or lactating
* Recreational tobacco or cannabis use
* Inability to perform the study exercise protocols
* Actively engaging in a low-carbohydrate diet (e.g., ketogenic, Atkins).
Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients with CKD Stage 3b and 4

Rationale: Several studies have shown that higher urinary potassium excretion (as proxy for potassium intake) is associated with better kidney outcomes, lower blood pressure and improved survival. These associations are also observed in patients with (advanced) CKD. However, application in daily practice in patients with CKD, is impaired by the risk of hyperkalemia, due to metabolic acidosis and impaired renal potassium excretion in these patients. As a consequence, patients with CKD are advised to restrict their intake of fruit and vegetables, as these healthy food components are important sources of dietary potassium. This is particularly undesirable for patients with CKD in view of the very high risk of cardiovascular disease.

Concomitant use of sodium zirconium cyclosilicate (SZC) could allow a more liberal intake of fruit and vegetables for patients with CKD, as SZC effectively treats hyperkalemia and counteracts metabolic acidosis \[1\]. With this strategy, the beneficial effects of potassium in fruits and vegetables on (vascular) health could also become accessible to patients with CKD.

Objective: To demonstrate that a potassium-rich diet, including the use of SZC as potential rescue treatment (in case of hyperkalemia), does not result in an unacceptable rise in plasma potassium (i.e. max rise of 0.5 mmol/L and no hyperkalemia). Study Design: Investigator initiated, single center, cross-over randomized clinical trial with non-inferiority design (14 weeks, 2 groups: regular diets vs. diet with potassium rich fruits and vegetables with sodium zirconium cyclosilicate if necessary) Study population: Outpatients ( age ≥ 18 years ) with chronic kidney disease stage IIIb/IV and use of inhibitor of the renin-angiotensin system (RASi).

Intervention: Addition of fruit- and vegetables that contain 40 mmol of potassium on top of regular diet. Addition of SZC after 1 week in case hyperkaliemia develops (serum potassium \&gt; 5,5 mmol/L). Weekly measurement of plasma potassium and dose adjustment of SZC if needed


Eligibility Criteria:
Inclusion Criteria:

* Chronic Kidney disease, stage 3 to 4b (eGFR 44-15 ml/min/1.73m\^2)
* Use of inhibitor of the renin-angiotensin system

Exclusion Criteria:

* Hyperkaliemia (plasma potassium \&gt; 5.5 mmol/L) at baseline or at the start of potassium enriched diet
* Use of potassium binders at baseline or at the start of potassium enriched diet
* Use of dual RAAS-blockade, mineralocorticoid receptor blockers or potassium-sparing diuretics
* Use of calcineurin inhibitors
* Use of trimethoprim and sulfamethoxazole
* Patients with a previous history of ventricular cardiac arrhythmia
* Patients with a prolonged QTc time on ECG
* Kidney transplantation patients
* Patients with a life expectancy of \&lt; 6 months
* Incapacitated subjects or subjects who are deemed unfit to adequately adhere to instructions from the research team
* Women who are pregnant, breastfeeding or considering pregnancy in the coming 6 months.
* Hypersensitivity to SCZ