cyrilzakka/clinical-trials huggingface dataset:
Irinotecan Plus Radiation Therapy Followed By Chemotherapy in Treating Patients With Glioblastoma Multiforme

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Irinotecan may make the tumor cells more sensitive to radiation therapy.

PURPOSE: This phase I/II trial is studying the side effects of irinotecan given together with radiation therapy followed by irinotecan and carmustine and to see how well it works in treating patients with newly-diagnosed glioblastoma multiforme.

OBJECTIVES:

* Determine the safety of adjuvant irinotecan when administered concurrently with radiotherapy in patients with newly diagnosed glioblastoma multiforme.
* Determine survival of patients treated with this regimen followed by irinotecan and carmustine.
* Assess the toxic effects of this regimen in these patients.
* Determine whether the dose of irinotecan chosen produces radiosensitizing plasma concentrations of SN-38 in these patients.
* Assess individual variation in responses (toxicity and/or activity), pharmacokinetic parameters, and/or biological correlates due to genetic differences in enzymes involved in transport, metabolism, and/or mechanism of action of irinotecan in these patients treated with this regimen.

OUTLINE: This is a pilot, dose-escalation study of irinotecan. Patients are stratified according to receipt of concurrent enzyme-inducing anticonvulsants (EIACs) (yes vs no).

* Phase I (closed to accrual as of 3/5/2005): Patients receive carmustine IV over 2 hours on day 1 of courses 2-5 and irinotecan IV over 90 minutes (beginning immediately after carmustine infusion) on days 1, 8, 22, and 29 of courses 1-5. Patients also undergo radiotherapy 5 days a week for 6 weeks concurrently with course 1 only. Treatment repeats every 6 weeks for 5 courses in the absence of unacceptable toxicity.

Cohorts of 6 patients receive escalating doses of irinotecan until the recommended dose for phase II is determined. The recommended dose for phase II is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity.

Eligibility Criteria:
* 18 years and older
* Histologically confirmed newly diagnosed grade IV astrocytoma or gliosarcoma
* No oligodendrogliomas/oligoastrocytomas
* Study entry must occur within 8 weeks after surgery
* Performance status - ECOG 0-2
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 130,000/mm\^3
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* SGOT ≤ 2 times ULN
* Creatinine ≤ 0.5 mg/dL above ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No uncontrolled infection
* No other concurrent malignant disease except superficial skin cancers
* No other major medical problems
* No prior chemotherapy
* No prior radiotherapy for any tumor
Acupuncture for Individuals With Stable Angina

This RCT aims to determine if it is possible to perform acupuncture on men and women diagnosed with stable angina who have symptoms, chest pain, and/or chest discomfort. The investigators want to determine if acupuncture reduces the pain and other symptoms of angina, chest pain, and chest discomfort. The investigators also want to examine whether this study is acceptable to the participants, and by carrying out this study the investigators will be able to tell how many participants they will need in a future larger study to further test acupuncture to reduce the symptoms of angina in women.

The investigators are conducting a RCT aimed at gathering feasibility, and initial efficacy for a randomized controlled trial (RCT) to test the effect of acupuncture on anginal symptoms, chest pain, and chest discomfort in men and women. The investigators long term goal is pain and symptom management resulting in improved functional status and quality of life for men and women with stable angina, chest pain, and chest discomfort. This study will include 69 community dwelling men and women with a medically confirmed diagnosis of stable angina, chest pain which includes non-ischemic or ischemic cardiomyopathy, microvascular coronary dysfunction (MCD), heart failure with preserved ejection fraction (HFpEF), heart failure with reduced ejection fraction (HFrEF), or chest discomfort whose pain and associated symptoms have not been completely controlled with guideline-directed medical management. The investigators will use a randomized attention control design with 13 men and women assigned to initial acupuncture and 13 to control. Participants in the experimental group will receive a standardized acupuncture point prescription two treatments per week, for 5 weeks. The attention control group will receive non-pain related video health education over 5 weeks equal to the approximate 10 hours of treatment for the acupuncture group.

Eligibility Criteria:
Inclusion criteria:

* provision of a verified diagnosis from a care provider
* male or female sex
* at least 21 years of age
* intermittent angina symptoms (pain, pressure, or discomfort in the chest or other areas of the upper body)
* medical confirmation of a diagnosis of stable angina for at least 6 months

medical confirmation of a diagnosis of chest pain including non-ischemic or ischemic cardiomyopathy

medical confirmation of a diagnosis of microvascular coronary dysfunction (MCD)

medical confirmation of a diagnosis of heart failure with preserved ejection fraction (HFpEF), heart failure with reduced ejection fraction (HFrEF) medical confirmation of chest discomfort.

Exclusion criteria:

* pregnancy
* chronic obstructive pulmonary disease (COPD) causing pain or associated symptoms
* autoimmune dysfunction
* use of steroid medications
* concomitant physical therapy
* biofeedback
* massage
* additional acupuncture
Effect of Probiotics on Recurrent Urinary Tract Infections

Randomized clinical trial to evaluate the effect of a probiotic mixture of Lactobacillus plantarum on recurrent urinary tract infections in women. Secondary outcomes comprise variation in vaginal/perianal microbiota, product tolerability, safety and consumer's satisfaction with the product.

Double-blind, randomized, placebo-controlled clinical trial to determine the effect of two probiotic strains of Lactobacillus plantarum on recurrent urinary tract infections in women. Women are randomized 1:1 to one of the following study groups: one group will receive a capsule/day of the mixture of Lactobacillus plantarum in combination with cranberry, and vitamine C; and the other group will receive a capsule of placebo for 6 months. Main study outcome is the number of women who have recurrence of UTIs during th estudy compared to the placebo group. Secondary outcomes comprise the duration of disease free period, duration and severity of symptomatology, the number of symptomatic UTIs during the study, variation of Lactobacillus plantarum levels in the vaginal/perianal microbiota, product tolerability, safety and consumer's satisfaction with the product.

Eligibility Criteria:
Inclusion Criteria:

* Women over 18 years of age.
* Women who have had at least one episode of UTI in the past 2 months
* Women with a well-documented history of recurrent UTIs: ≥2 infections in the past 6 months or ≥3 in the past 12 months.
* Women who have been treated with an antibiotic regimen for each episde of UTI
* Recurrence due to reinfection, not relapse: multiple infections should be spaced by a minimum of 2 weeks or in case of a shorter time, with negative urine culture between them
* Women who use contraception to prevent pregnancy and who do not plan a pregnancy during the study period

Exclusion Criteria:

* Pregnant or breastfeeding women
* Underlying chronic disease: diabetes mellitus, kidney failure, cancer, spinal cord injury, polycystic ovary
* Women wih catheters in the urethra
* Women who consume probiotics or foods, beverages or supplements containing extracts or parts of the genus Vaccinum sp, including other forms of V. macrocarpon (blueberry), V. myrtillus (European blueberry), V. angustifolium (wild or low buch blueberry), V. corymbosum (tall bch blueberry) or V. vitis-ideae (mountain blueberry) during the 2 weels prior to recruitment.
* High consumption of fruits rich in phenolic compounds, with special reference, to berries
* Women allergic to red fruits
* BMI ≥ 40 Kg/m2
Pharmacokinetics of AZD7295 Capsules

This is a pharmacokinetics (PK) and safety study of AZD7295 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female volunteers, aged 18-65 years.

Exclusion Criteria:

* Previous exposure to AZD7295, clinically relevant disease.
Phase I Study of MK-0683 in Combination With Bortezomib in Participants With Multiple Myeloma (MK-0683-098)

The primary purpose of this clinical study is to determine the recommended clinical doses of vorinostat (MK-0683) and bortezomib administered in combination to participants with relapsed and/or refractory multiple myeloma (MM). It was hypothesized that administration of vorinostat in combination with bortezomib is sufficiently safe and tolerated well enough to permit further study in participants with relapsed and/or refractory MM. Study results are based on data collected up to the data cut-off date of 20-March-2011.


Eligibility Criteria:
Inclusion Criteria:

* is ≥20 years of age.
* has an established diagnosis of MM based on the myeloma diagnostic criteria
* has received at least 1 but not more than 3 prior anti-myeloma regimens and has progressive disease after the most recent treatment regimen
* has adequate organ function

Exclusion Criteria:

* has had a prior allogeneic bone marrow transplant or plans to undergo any type of bone marrow transplantation during the study
* has known hypersensitivity to any components of vorinostat or bortezomib
* has active hepatitis B or C, plasma cell leukemia, or is human immunodeficiency virus (HIV) positive
* has had prior treatment with vorinostat or histone deacetylase (HDAC) inhibitors
Portuguese Registry on Acute Coronary Syndromes

The purpose of this Registry is creating a database management that allows continuous monitoring characteristics, evolution, prognostic indicators and management of patients with ACS admitted in Portuguese Hospitals, and identify the appropriateness of clinical practice recommendations for diagnosis and treatment of ACS and monitor its evolution.

Cardiovascular diseases remain the principal causes of death in Portugal and approximately one quarter of these are directly to ischemic heart disease, especially Acute Coronary Syndromes (ACS).

In order to reduce mortality for ACS, a significant number of new drugs and new techniques have been introduced into clinical practice, resulting in important heterogeneity of approach and treatment of patients with ACS.

The Portuguese Society of Cardiology have sought to review and incorporate in its recommendations the evidence to date, with the aim to standardize diagnosis and treatment of patients with ACS, which is not always able to in daily practice.

Since it is essential to characterize the national reality of the ACS, the Portuguese Society of Cardiology has promoted the Portuguese registry on Acute Coronary Syndromes, aimed at bridging the knowledge gaps in this area of cardiovascular disease.

This will include all adult patients (≥ 18 years) diagnosed with Acute Coronary Syndrome (ACS) with \<48 hours of evolution. The inclusion is of responsibility of the last service of Cardiology where the patient was hospitalized. The ACS is set to the presence of angina at rest last 48 hours, with 1) ischemic electrocardiographic changes ST-segment deviations or negative T waves, and / or 2) elevation of biomarker (cardiac troponin and CK-MB) above the reference value. For diagnosis ACS with ST elevation is considered to be persistently elevated (\> 30 minutes) of the ST segment. The rest should be considered as ACS ST-segment elevation. In the absence of angina, the SCA will be considered consistent elevation (curve ascending / descending) biomarker (above reference value for cardiac troponin or higher 2 times the value of reference to the CK-MB) associated with other clinical manifestations such as ill-defined chest discomfort or dyspnea.

Are included patients participating in clinical trials

Are excluded patients with MI after revascularization procedures (EAM type 4 and 5) and MI type 2 (classification according to the redefinition of Myocardial Infarction, 2007 the Joint ESC / ACCF / AHA / WHF Task Force)

Eligibility Criteria:
Inclusion Criteria:

* presence of angina at rest last 48 hours, with: 1) ischemic electrocardiographic changes - ST-segment deviations or negative T waves, and / or 2) elevation of biomarker(cardiac troponin and CK-MB) above the reference value.

Exclusion Criteria:

* patients with MI after revascularization procedures (EAM type 4 and 5) and MI type 2 (classification according to the redefinition of Myocardial Infarction, 2007 the Joint ESC / ACCF / AHA / WHF Task Force).
Early Use of Norepinephrine in Septic Shock Resuscitation

Current septic shock guideline recommends fluid resuscitation as the first treatment. Vasopressors, including norepinephrine is recommended to start after achieve adequate fluid therapy. This can cause a certain duration of systemic hypotension before vasopressor is commenced. Initiation of norepinephrine together with fluid therapy soon after diagnosis of septic shock may increase blood pressure quicker than start treatment with intravenous fluid alone. The rapid restoration of perfusion pressure may improve septic shock outcome.

We will include severe infection patient who had evidence of organ dysfunction and hypotension and randomize into 2 groups as following:

1. Control group. The patient will receive treatment according to septic shock guideline 2013, which start with intravenous fluid replacement until achieve target central venous pressure (CVP) or pulmonary capillary wedge pressure (PCWP) or other fluid responsive test goal. If the patient's mean arterial blood pressure still lower than 65 mmHg, then norepinephrine or dopamine will initiate to rise blood pressure. The patient will receive 5% dextrose water as the placebo of norepinephrine.
2. Early norepinephrine group. The patient will receive fluid therapy together with low dose of norepinephrine (0.05 mcg/kg/min). If after titrate intravenous fluid therapy until achieve goal CVP or PCWP or other fluid responsive test, but the mean blood pressure still lower than 65 mmHg, then additional titrate dose of norepinephrine will be given to the patient according to standard septic shock guideline.

Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years old
* Diagnosed severe sepsis or septic shock according to survival sepsis campaign 2013
* Mean arterial pressure \< 65 mmHg

Exclusion Criteria:

* Pregnancy
* Severe underlying condition that unexpected to survive more than 48 hours
* Severe peripheral vascular disease
* Patient who required major surgery within 24 hours
Single Anastomosis Duodeno-Ileal Bypass vs Standard Duodenal Switch as a Second Step After Sleeve Gastrectomy in the Super-Morbid Obese Patient

Single-Anastomosis Duodeno-Ileal bypass with a 250 cm common/alimentary loop is a modification of standard duodenal switch in which a Roux-en-Y duodeno-ileal anastomosis is performed at 250 cm from the cecum and a 60 cm to 100 cm common channel is build up. Hypothesis of the study is that Single-Anastomosis Duodeno-Ileal bypass behaves at least equally to standard duodenal switch as a second step after sleeve gastrectomy in the super-morbid patient. Secondary aims are to demonstrate that single-anastomosis duodeno-ileal bypass is simpler to perform, quicker and has less postoperative short, mid and long-term complications.

Sleeve gastrectomy is a restrictive operation for morbid obesity which has a 60% success rate in solving both morbid obesity and related co-morbidities, mainly diabetes mellitus. When the sleeve is not enough for the patient, due to alimentary habits or to an excessive initial BMI before surgery (usually over 50 - 55), a second-step operation should be performed to increase effectiveness. Some patients are submitted to a second restrictive operation, i.e.: a re-sleeve, a gastric plication or sleeve banding. Other group are offered a gastric bypass. And, finally, a subset of patients, generally those with higher initial BMI, are offered a malabsorptive operation. While re-sleeve is adequate for many patients, gastric bypass is not offering a greater weight loss rate, and it is a complex operation requiring sectioning of the sleeve and two anastomoses. We support the performance of malabsorptive operations which warrant a better weight loss result for "resistant" patients needing a second-step. As Single-Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy (SADI-S) has behaved as a good primary operation for morbid obesity, we decided to test this one-loop reconstruction as a second step operation. Results will be compared to those obtained with a Roux-en-Y duodenal switch performed as a second step after a "failed" sleeve.

Eligibility Criteria:
Inclusion Criteria: Morbid obesity with initial BMI over 50 submitted to Sleeve Gastrectomy more than 18 months earlier. Excess weight loss with the sleeve under 50%.

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Exclusion Criteria: Mental retard, alcoholism, age over 60, concomitant neoplastic disease.

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The Effect of Milk Powder With Fiber and Probiotics on Digestive Habits and General Health Well-being of Selected Filipino Mothers.

In-Shape Nutritional Milk Powder is a nutritional milk powder containing fibers, probiotics and other nutrients. This study will focus on the effects of fiber and probiotics on digestive health and health well being in selected Filipino mothers


Eligibility Criteria:
Inclusion Criteria:

* Female between 21 and 35 years of age.
* Has at least one child under the age of three.
* Willingness and ability to participate in the study.
* Suffering from mild to moderate constipation and bowel troubles, and non-specific symptoms including bloating, flatulence, gurgling, feeling heavy after eating, and abdominal pain.
* Slow transit or irregular bowels movements (stool consistency harder than usual or fewer bowel movements, i.e. every 2-3 days or less than 3 bowel movements per week).
* Agree to maintain dietetic measures (on their own volition or as previously recommended by health/nutrition professionals), if any, during the study period.
* Subject, or subject's legally acceptable representative, has voluntarily signed and dated an informed consent form, approved by a local Ethics Committee/Institutional Review Board authorization prior to any participation in the study.

Exclusion Criteria:

* Having participated in another trial currently and up to two months prior to this trial date.
* Known chronic constipation.
* Treated gastrointestinal symptoms.
* Regular intake of laxatives or other remedies to promote digestion (herbal teas, peppermint etc.) during the two weeks before the start of the study or during the study.
* Consuming dairy products or supplements containing Probiotics (e.g., yogurt, Lactic acid drink, drinkable yogurt, food supplements, extracts), Prebiotics (e.g., Oligosaccharides), or fiber supplements within 10 days prior to the start of the study or during the study.
* Currently taking (and during the past 3 months) any dietary fiber supplementation except from food sources.
* Previous contraindication to fiber supplement (Crohn's disease).
* Recently or currently on antibiotic medication in the past two weeks.
* Known allergy to milk proteins or intolerance to lactose.
* Currently pregnant.
Comparison of Intraligamentary Anesthesia With the Inferior Alveolar Nerve Block for the Extraction of Mandibular Molars.

Local anaesthesia or numbing is done before tooth extraction. This study compares two different methods of numbing molar teeth before extraction. It compares them on the basis of pain during the procedure and on discomfort after the procedure as well. It will help dentists better understand the benefits of the two techniques, and their usage case to case.

The study was designed as a randomized controlled trial. The purpose of this study was to examine the differences in efficacy of the intraligamentary anaesthetic technique and the inferior alveolar nerve block for mandibular posterior tooth extraction cases. Pain intensity, duration of anaesthesia, incidence of post-operative dry socket, success rates, onset of anaesthesia were examined. It was done in a split-mouth method so that two different techniques were used in the same patient, thus minimizing individual variations.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes who were more than 18 years of age; they had indications of non-surgical extraction of one or multiple mandibular posterior teeth.

Exclusion Criteria:

* For patients: pregnancy, immunological compromise, systemic conditions requiring special considerations and non-compliance.
* The exclusion criteria for individual teeth were: acutely infected teeth or any teeth with the instances of expression of pus through sinus tracts or the gingival sulcus were excluded. In case of multiple unilaterally indicated teeth that were to be extracted under IANB, only the tooth best fitting all criteria was considered for the study.
Effects of Levothyroxine Supplementation in Patients With Systolic Heart Failure and Subclinical Hypothyroidism

The purpose of this study is to determine whether levothyroxine supplementation is beneficial in patients with systolic heart failure and subclinical hypothyroidism on the functional class evaluated with a 6 minute walk test.

Forty patients with systolic heart failure and subclinical hypothyroidism will be include in a open label trial. They will receive levothyroxine supplementation to determine if their functional class will be affect.

Eligibility Criteria:
Inclusion Criteria:

* Biochemical diagnosis of subclinical hypothyroidism (TSH between 3.5 and 10 with a normal T4)
* Systolic heart failure with New-York Heart Association (NYHA) class II or III
* Left ventricular ejection fraction under 40%
* Stable heart failure for the past 3 months (no IV furosemide or hospital admission)
* Beta-blockers and ACE inhibitors titrated to the maximum tolerated dose

Exclusion Criteria:

* Isolated diastolic heart failure
* Awaiting cardiac resynchronisation therapy
* Impossibility to perform the 6 minutes walk test
* Active cancer / Life expectancy under 18 months
* Treatment with amiodarone