cyrilzakka/clinical-trials huggingface dataset:
A Research Trial of High Dose Vitamin C and Chemotherapy for Metastatic Pancreatic Cancer

This study is designed to determine the maximum tolerated dose of vitamin C when given with a standard chemotherapy for people who have metastatic pancreatic cancer.

This is a phase I, dose-escalating study of ascorbic acid (vitamin C) designed to determine the maximum tolerated dose of vitamin C or, if well tolerated, the dose required to obtain a desired ascorbic acid plasma concentration.

Because this is a phase I study, prospective subjects should have advanced disease (i.e., metastasis) and have failed other curative therapies (or, are unable to receive curative therapies due to comorbidities or stage of disease).

Eligibility Criteria:
Inclusion Criteria:

* Normal G6PD status
* Histologically or cytologically diagnosed pancreatic adenocarcinoma.
* Disease extent documented by CT scan (radiologically measurable disease is not required)
* Ambulatory patient without evidence of spinal cord compression
* No prior chemotherapy for metastatic disease
* Failed curative therapy or patient ineligible for definitive curative therapy
* Completed adjuvant therapy at least 4 weeks prior and recovered from any/all toxicities related to that treatment.
* If post-therapy, must have disease progression since that treatment
* If treated with prior radiation therapy, disease must be outside of the radiation fields
* No currently active second malignancies unless it is a non-melanoma skin cancer
* Women must be non-pregnant and non-lactating
* ECOG performance of 0, 1, or 2
* Granulocytes at least 1,500 / ul
* Platelets at least 100,000 / ul
* Creatinine less than 1.5 mg/dL or clearance of at least 60 mL / min
* Total bilirubin less than 2 times the upper limit of normal
* AST and ALT less than 3 times the upper limit of normal if liver metastases are not present. If liver metastases are present, AST and ALT less than 5 times the upper limit of normal
* PT INR less than 1.5 (unless the patient is on full dose warfarin)
* Patient must be at least 18 years of age
* Patient must be able to understand consent process, the research study, and be able to sign the consent document

Exclusion Criteria:

* A psychiatric disorder by history or examination that would prevent completion of the study
* ECOG performance of 3 or 4
* Co-morbid conditions that affect survival: end stage congestive heart failure, unstable angina, myocardial infarction (within the past 6 weeks), uncontrolled blood sugars of greater than 300 mg/dL, known chronic active hepatitis or cirrhosis.
* Consumption of excess alcohol (more than 4 drinks per day) or use of illicit drugs
* Continued sse of over-the-counter antioxidants (supplements like vitamin C and grape seeds)
A Study to Explore the Influence of Two Opioid Pain Medications on Bacterial Composition in the Gut and Other Gastrointestinal Aspects

The study is intended to explore changes in the composition and quantity of gut bacteria subject to treatment with strong pain medication. Two pain medications will be compared (OXN PR and OxyPR). Other gastrointestinal parameters will be assessed.

Patients who require around-the-clock opioid therapy and show symptoms of constipation secondary to opioid treatment will be randomised to receive either OXN PR followed by OxyPR, or vice versa. Each treatment takes 24days. The study is composed of three phases, a pre-randomisation phase, a double-blind phase and a Follow-up phase.

Eligibility Criteria:
Inclusion Criteria:

Subjects who are receiving WHO step II/III opioid analgesic medication for the treatment of non-malignant pain and who require daily opioid treatment for pain with WHO step III opioid therapy for the duration of the study, based on Investigator's judgement.

Documented history of non-malignant pain that requires around-the-clock opioid therapy (20 - 50 mg oxycodone PR equivalent per day for a minimum of study duration).

Subjects with constipation caused or aggravated by opioids:

* Subject's medical need of regular intake of laxatives to have at least 3 bowel evacuations per week, or having less than 3 bowel evacuations when not taking a laxative.
* In the opinion of the subject and investigator confirm that the subject's constipation is induced, or worsened by the subject's prestudy opioid medication (present at Screening).

Exclusion Criteria:

Any contraindication to oxycodone, naloxone, or any non-investigational medicinal products (NIMPs) that will be used by subjects during the study.

Continuous systemic use of antibiotics and/or steroids within the last 4 weeks prior to the start of the Screening Period and during the study period.

Chronic or intermittent pain that results from Fibromyalgia or Rheumatoid Arthritis
Sportcheck Follow-Up

The study resembles a four-year follow-up on the influence of physical activity and fitness, blood pressure, BMI and stress on vascular health in primary schoolchildren. It examines the predictive value of retinal vessel diameters for the development of childhood hypertension.

The study aims to examine the usefulness of retinal vessel analysis in childhood cardiovascular prevention. It investigates the long-term influence of physical activity and fitness on retinal vessel diameters, blood pressure, BMI and psychosocial stress in children. The study aims to set new standards for an integrative primary prevention concept to initiate healthy ageing from childhood to adulthood.

Eligibility Criteria:
Inclusion Criteria:

* All fifth-graders of public primary schools in Basel-Stadt with an informed consent signed by their parents are included.

Exclusion Criteria:

* Fifth-graders with motor-or other disabilities that do not allow participation will be excluded.
Evaluation of the Safety, Tolerability and Pharmacokinetics of Repeat Oral Doses of GSK580416

This study will evaluate the safety, tolerability and exposure of repeat escalating oral doses, a loading dose/maintenance dose regimen of GSK580416 and when co administered with ketoconazole, a PGP/CYP3A4 inhibitor.

A three part study in healthy adult subjects to evaluate the safety, tolerability and pharmacokinetics of repeat escalating oral doses of GSK580416; the safety, tolerability, and pharmacokinetics of GSK580416 following a loading dose regimen; and the effect of ketoconazole on the pharmacokinetics of GSK580416

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults (as determined by medical evaluation including history, physical exam, vital signs, laboratory tests, and cardiac monitoring)
* Aged 18-60yrs, with BMI of 19-31kg/m2.
* Females must be of non-childbearing potential.
* QTc \< 450 msec at screening.
* Subjects must be able to give consent and comply with restrictions of study.

Exclusion Criteria:

* Clinically significant CNS, cardiac, pulmonary, metabolic, renal, hepatic or GI condition or history that may place the subject at an unacceptable risk or may interfere with absorption, distribution, metabolism, or excretion of drug.
* Positive urine drug screen.
* Positive urine test for alcohol.
* Positive HIV or Hep B and/or C assay.
* History of regular tobacco use within 3 monts prior to screening or cotinine levels indicative of smoking at screening.
* History of regular alcohol consumption (14 units/week for women and 21 units/week for men).
* History of drug abuse or dependence within 12 months of study.
* Participation in another drug trial within 30 days of first dose.
* Exposure to more than 4 new chemical entities within 12 months of first dose.
* Use of prescription and non-prescription drugs including vitamins, dietary supplements, herbals within 7 days of first dose or St. John's Wort within 28 days of the first dose.
* Consumption of red wine, Seville oranges, grapefruit, or grapefruit juices within 14 days of first dose.
* Donation of blood in excess of 500 mL within 56 days of dosing. No blood donation is allowed 30 days prior to study participation.
* A positive immunochemical fecal occult blood test at screening.
* History of sensitivity to any of the study medications.
* History of sensitivity to heparin or heparin-induced thrombocytopenia.
* History of orthostatic hypotension or orthostatic hypotension at screening.
The Thai Surgical Intensive Care Study (Thai-SICU Study)

The study observed the 28 days mortality of 9 participated University base surgical intensive care unit (SICU) as well as the occurrence of adverse events in SICU.

The adverse events included pulmonary aspiration, pulmonary emboli, drug error, new stroke, symptomatic deep vein thrombosis, pneumothorax, unplanned extubation, upper GI hemorrhage, myocardial infarction, abdominal hypertension, acute lung injury(ALI)/acute respiratory distress syndrome (ARDS), re-intubation within 72 hours, delirium, cardiac arrest, new arrhythmia, acute kidney injury, sepsis

Eligibility Criteria:
Inclusion Criteria:

* All SICU admission patients

Exclusion Criteria:

* Age \< 18 years
Second Laparoscopic Surgery for Recurrent Unilateral Endometriomas.

This retrospective case-control study was performed in an Academic centre for the diagnosis and treatment of endometriosis. It included patients with recurrent unilateral endometriomas who were previously operated for the same condition (cases) and patients without recurrency who previously underwent surgery for unilateral endometrioma (controls). The primary outcome of the study was to assess the impact on ovarian reserve of second surgery for recurrent unilateral endometriomas. The evaluation of ovarian reserve was performed by assessing serum anti-mullerian hormone (AMH) level, serum follicle-stimulating hormone (FSH) level, 17-beta estradiol level and antral follicle count (AFC).


Eligibility Criteria:
Inclusion Criteria:

* reproductive age (at the time of both surgical procedures);
* two surgical procedures on the same ovary (stripping of endometrioma with
* largest diameter ≥ 4 cm; cases) performed at our Institution;
* one surgical procedures (stripping of endometrioma with largest diameter ≥ 4 cm; controls) performed at our Institution;
* histological diagnosis of ovarian endometriomas;
* complete assessment of ovarian reserve at routinary follow-up at our institution.

Exclusion Criteria:

* patients aged ≥ 40 years at the time of primary surgery;
* surgical procedures on the contralateral ovary (at primary or second-line surgery);
* previous salpingectomy or hysterectomy;
* unilateral ovariectomy at the time of first or second surgery;
* ultrasonographic diagnosis of persistent endometrioma after first surgery;
* additional surgical procedures for endometriomas or for other ovarian diseases before first surgery and between first and second surgery;
* hormonal treatment within 3 months from ovarian reserve assessment;
* patients followed-up \< 3 months after second-line surgery (for cases).
* pregnancy and/or breastfeeding during the study period.
Phase IV Study to Compare Efficacy and Safety of Plavix 75mg With Astrix 100mg and Closone

The Aim of this study is to prove non-inferiority of Closone to the Combination treatment of Plavix with Astrix.


Eligibility Criteria:
Inclusion Criteria:

* Subjects under a stable condition after Post-Percutaneous Coronary Artery Intervention over three months
* 20\~86 years old
* Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria:

* Subject who did not undergo or failed Drug-Stent Implantation
* Subjects who took an anti-coagulant, anti-thrombotic regularlly( ≥ 2weeks in a month) before the study, or plan to have continuous treatment during the study(Except Aspirin alone or combination of Aspirin and Clopidogrel)
* Subjects with a history of substance or alchol abuse
* Subjects with a history of hypersensitivity to Clopidogrel, Aspirin or other NSAIDS
* Subjects having Aspirin or other NSAIDs-induced Asthma or history
* Subjects with Severe hepatopathy(AST and ALT \> 5 times the upper limit of normal)
* Subjects with Severe nephropathy(Cr \> 3 times the upper limit of normal)
* Subjects with hemorrhage like gastric ulcer, intracranial hemorrhage etc.
* Subjects with high risk of hemorrhage like blood coagulation disorders, uncontrolled severe hypertension, active bleeding, history of severe bleeding
* subjects who are pregnant, breastfeeding
* Subjects not using medically acceptable birth control
* Subjects who are unsuitable to take the Investigational product due to a medical/mental condition
* Subjects inherently having Galactose malobsorption, Lactase deficiency or Glucose-Galactose malobsorption
IS-002 Phase 2 Prostate Cancer Study

Phase 2 randomized controlled multi-center study of IS-002, in conjunction with near-infrared (NIR) fluorescence imaging, for identification of prostate cancer during robotic-assisted radical prostatectomy (RARP) with (extended) pelvic lymph node dissection ((e)PLND) using the da Vinci® X/Xi Surgical System with Firefly® Fluorescence Imaging.


Eligibility Criteria:
Inclusion criteria

1. Subjects aged 18 to 75.
2. Subject has a confirmed adenocarcinoma of the prostate as defined by (histo-) pathology.
3. Subject has CAPRA ≥6; or ≥T3 disease on imaging (TRUS and/or MRI); or a Gleason sum score ≥8; or regional lymphadenopathy suspicious for nodal metastases on imaging.
4. Subject is scheduled to undergo robotic-assisted radical prostatectomy (RARP) with (extended) pelvic lymph node dissection ((e)PLND) using a da Vinci® X/Xi Surgical System equipped with Firefly® Fluorescence Imaging.
5. Subject is willing and able to provide written informed consent.
6. Subject can comply with the study procedures and study visits and understands an informed consent document.

Exclusion criteria

1. Subject has known bone metastasis.
2. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
3. Subject has a known history of acute or chronic liver or kidney disease.

   • Renal function at screening: i. Creatinine clearance: \<50 mL/min as determined using the Cockcroft-Gault formula ii. Albumin: \<LLN

   • Hepatic function at screening: i. AST and/or ALT: \>2.5x ULN ii. Total Bilirubin (serum): \>1.5x ULN
4. Subject has received neo-adjuvant therapy, radiation therapy, focal ablation therapy, hormonal therapy, or androgen deprivation therapy within the last 4 months.
5. Subject is currently receiving an investigational therapeutic agent; or has participated in a study of an investigational therapeutic agent within the past 6 months prior to the day of IS-002 infusion; or is involved in a significant risk investigational device study within the past 6 months prior to the day of IS-002 infusion.
6. Subject has any other condition or personal circumstance that, in the judgment of the site Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile.
Motivational Interviewing in Adolescents With Epilepsy

Epilepsy is the most common serious neurodevelopmental disorder of childhood characterized by recurrent seizures, affecting approximately 0.9% of children and adolescents worldwide. Although epileptic seizures are an important element of epilepsy in children, there are many neurological, mental health and cognitive comorbidities in childhood epilepsy that increase the burden of the disease and cause a decrease in quality of life. Motivational interviewing has been found to have a positive effect on the treatment and prevention of chronic diseases; It is a patient-centered counseling that explores, strengthens, and directs the individual's motivation for change.

Adolescence period; It is an important stage of development in which the self-concept develops, self-related schemas are created and carried into adulthood. During this formative period of life; Adolescents experience increasing levels of uncertainty and self-consciousness as they progress through the task of identity formation. It is greatly influenced by social interactions, especially interactions with peers.Children and adolescents with epilepsy are at increased risk for social problems, reduced social competence, poor social skills, and deficits in social communication compared to healthy children. Compared to youth with other chronic diseases, youth with epilepsy have higher rates of comorbid neurological disorders, academic failure, poor social skills, stigma, poor quality of life, and behavioral health problems (e.g., anxiety, depression). They often experience low quality of life because they feel unsafe and fear having a seizure in public. In a study aiming to investigate the factors affecting the level of social anxiety in epilepsy, it was concluded that social anxiety is independently associated with low quality of life. In a meta-analysis study; It was concluded that the motivational interviewing method applied by nurses increased the quality of life of individuals with chronic diseases. When the literature was examined, no study was found that addressed the motivational interviewing technique applied to the social anxiety and quality of life of adolescents with epilepsy. Motivational Interviewing Technique applied to adolescents with epilepsy; It is thought that it will be effective in reducing social anxiety and increasing the quality of life by enabling adolescents to become aware of their situation, get rid of the ambivalent (opposite emotional state) they experience, and take action to change.

Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 12-15
* Having epilepsy for at least six months
* Having a high score on the Social Anxiety Scale for Adolescents
* Having a low score on the General Child Life Quality Scale
* Low scores on the KINDL Epilepsy Quality of Life Module for Children
* No mental disability
* Able to communicate (can speak and understand Turkish, has no speech disorder)
* Being literate
* Not having any other chronic disease
* Being willing to participate in the study

Exclusion Criteria:

-Not attending at least one of the interviewing
Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis

To investigate whether cyclosporine, added to methotrexate and steroid, increases the possibility of inflammatory management early in the disease; furthermore to investigate the possible steroid-sparing effect of cyclosporine in patients with recently diagnosed rheumatoid arthritis.

Design: Multicentre, prospective, randomised, double-blind study with parallel design.

Selection of patients: Patients with recently diagnosed rheumatoid arthritis (less than 6 months of persistent synovitis).

Eligibility Criteria:
Inclusion Criteria:

* Synovitis in at least 2 joints.
* Compliance with the ACR criteria for RA.
* Duration of no more than 6 months (from the first anamnestic non-traumatic synovitis of at least 6 weeks' duration).
* Informed consent.

Exclusion Criteria:

* Age less than 18 years or more than 75 years
* Lack of co-operability.
* Previous treatment with DMARD
* Corticosteroid treatment during the preceding 4 weeks.
* Contra indications for the treatments (awaiting the recommendations from Novartis)
* Previous or present malignant or premalignant disease
* Poorly regulated hypertension
* Impaired renal function
* Immuno defective diseases, including HIV
* Cardiac or pulmonary insufficiency
* Serious arteriosclerosis
* Serious granulocytopenia or thrombocytopenia
* Impaired liver function (liver enzymes more than twice the highest normal limit).
* Alcohol consumption of more than 3 drinks a week.
* Poorly controlled epilepsy
* Lack of contraception in fertile patients
* Pregnancy and lactation
* Psoriasis
* Poorly regulated diabetes
* Anticoagulant treatment
* Known allergy to the medicine
* Medicamental interactions
* Other inflammatory rheumatic diseases
To Explore the Safety and Efficacy of Intravenous Infusion of Different Doses of Lidocaine in Patients

All patients who met the inclusion criteria were randomly divided into four groups, 30 cases in each group, which were lidocaine group 1, lidocaine group 1.5, lidocaine group 2, and the placebo group In lidocaine group 1, lidocaine group 1.5, and lidocaine group 2, 1% lidocaine 1.5 mg/kg was intravenously infused with a micropump after anesthesia induction, and the infusion was completed within 10 minutes according to the ideal body weight, and then continued for 1% lidocaine was infused at 1 mg/kg.h, 1.5 mg/kg.h and 2 mg/kg.h respectively until the end of the operation. In the placebo group, the same volume of normal saline was used instead.

All patients who met the inclusion criteria were randomly divided into four groups, 30 cases in each group, which were lidocaine group 1, lidocaine group 1.5, lidocaine group 2, and the placebo group In lidocaine group 1, lidocaine group 1.5, and lidocaine group 2, 1% lidocaine 1.5 mg/kg was intravenously infused with a micropump after anesthesia induction, and the infusion was completed within 10 minutes according to the ideal body weight, and then continued for 1% lidocaine was infused at 1 mg/kg.h, 1.5 mg/kg.h and 2 mg/kg.h respectively until the end of the operation. In the placebo group, the same volume of normal saline was used instead.Postoperative pain management during the first 72 postoperative hours will involve the use of a PCIA device, which will contain lidocaine 30mg/kg, sufentanil 2 μg/kg, granisetron 12 mg diluted to 200 mL in 0.9 % normal saline. In the placebo group, the same volume of normal saline will be administered during anesthesia. The postoperative PCIA device will contain sufentanil 2 μg/kg, granisetron 12 mg diluted to 200 mL in 0.9% normal saline solution with a total volume of 200 ml. All the background infusions of PCIA will set at 2 ml/h, the bolus volume of each PCIA press is 2 ml and the lockout interval is 15 min.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-70 years old
* American Society of Anesthesiologists(ASA) Ⅰ～III
* BMI≤30
* Intended for open liver resection Exclusion criteria：1. Long-term opioid users 2. Patients with contraindications or allergies to any drugs (lidocaine, etc.) used in this study 3. Patients with severe hepatic insufficiency before surgery (defined as total bilirubin\>1.46mg/dl), renal insufficiency (glomerular filtration rate \<30ml/min/1.73m2 or end-stage renal disease) 4. Associated with severe heart disease (second or third degree atrioventricular block); severe heart failure (ejection fraction \<50%); sinus bradycardia; patient 6. Patients who participated in other clinical trials within 3 months before enrollment in the study.
The Evaluation of a Mask Seal/Mask for the Treatment of Obstructive Sleep Apnea (OSA)

This investigation is designed to evaluate the performance as well as the patients overall acceptance of the seal/mask.

A minimum of 15 OSA participants who currently use a Full face mask will be recruited for the trial. Participant will be on the trial for 1 week- The participant will use the trial seal in-home for 1 week.

An additional 5 Participants will be added to the study to use the entire mask in home for 14+-4 days as an extension to the original trial.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18+ years of age)
* Able to give consent
* Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
* Prescribed PAP for OSA
* Existing oro-nasal mask user

Exclusion Criteria:

* Inability to give consent
* Patients who are in a coma or a decreased level of consciousness
* Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
* Commercial drivers who are investigated by New Zealand Transport Agency
* Current diagnosis of carbon dioxide (CO2) retention
* Pregnant or may think they are pregnant