cyrilzakka/clinical-trials huggingface dataset:
S9717 Tirapazamine Plus Cisplatin in Treating Patients With Metastatic, Recurrent, or Refractory Cervical Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of tirapazamine plus cisplatin in treating patients who have metastatic, recurrent, or refractory cervical cancer.

OBJECTIVES: I. Evaluate the survival of patients with metastatic or recurrent epithelial squamous or adenosquamous carcinoma of the cervix when treated with intravenous tirapazamine plus intravenous cisplatin. II. Evaluate the unconfirmed complete and partial response rates of these patients, as well as, the nature and degree of toxicity associated with this regimen in this patient population.

OUTLINE: Patients receive tirapazamine intravenously over 2 hours and then, following a 1 hour rest, receive cisplatin intravenously over 1 hour. Courses are repeated every 21 days. Treatment continues for 6-10 courses in the absence of unacceptable toxic effects or disease progression. All patients are followed every 6 months for 2 years, then annually thereafter until death.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed squamous or adenosquamous carcinoma of the cervix that is metastatic, recurrent, or refractory Any stage disease treated with prior radical surgery and/or definitive radiotherapy that has locally recurred and is no longer amenable to surgery or radiotherapy OR Metastatic disease that is not amenable to surgery or radiation therapy Measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 1.5 times upper limit of normal Other: No history of allergic reaction to mannitol Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No other prior malignancy except: Adequately treated basal cell or squamous cell skin cancer In situ cervical cancer Adequately treated stage I or II cancer from which the patient is currently in complete remission Any other cancer from which the patient has been disease free for 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factor therapy Chemotherapy: Prior chemotherapy (hydroxyurea, fluorouracil, metronidazole, cisplatin, or other platinum agent) allowed as a radiosensitizing agent only No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Prior radiotherapy allowed to less than 30% of the bone marrow only Recovered from toxic effects No concurrent radiotherapy Surgery: See Disease Characteristics Prior surgery allowed Recovered from effects of prior surgery Other: No prior systemic therapy for this disease
Maintenance Study of Certolizumab Pegol (CZP) in Crohn's Disease

This is a multi-centre, open-label extension study in subjects who showed clinical response to induction therapy in the treatment of subjects with active Crohn's disease in the double-blind main study C87037 (NCT00291668).

In the double-blind main study subjects were dosed at Weeks 0, 2 and 4, with the primary outcome, clinical response, being assessed at Week 6. Subjects who showed clinical response at Week 6 were eligible to enter this open-label extension study. The first visit in this extension study was 2 weeks after Week 6, i.e., Week 8. Subjects in this extension study were dosed at Weeks 8, 12, 16, 20 and 24, with the primary outcome, clinical response, being assessed at Week 26. All week numbers quoted are relative to the start of the double-blind main study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who participated in main double-blind induction study C87037 (NCT00291668) and showed clinical efficacy

Exclusion Criteria:

* Subjects who experienced aggravation of Crohn's disease during main double-blind induction study C87037 (NCT00291668) and required treatment change
Mechanisms of Somatic Mutation and Tumor Initiation in Pre-malignant Kidney Tubule Cells

The goal of this observational study is to analyze somatic mutations in the genome of normal kidney cells from patients affected by kidney cancer predisposition syndrome Von Hippel Lindau (VHL) and compare the mutation rates observed in these patients and in individuals not affected by the disease. The main questions the study aims to answer are:

* Do kidney cells from VHL patients mutate more than cells from control individuals during adult life?
* What mechanisms favor somatic mutation occurrence in the genome of normal kidney tubule cells?

Participants will donate one blood sample and multiple urine samples. Urines will be used for kidney cell isolation, followed by cell culturing and genetic analyses. Urine samples will be collected once a year for 3-5 years. Sample collection will occur during the yearly screening program that each patient undergoes at the hospital. In case patients undergo surgical treatment of kidney tumors, samples discarded from surgery (tumor and normal kidney adjacent to tumor) will be collected and subjected to genetic analyses.

Researchers will compare the number and types of mutations found in tumors and normal kidney cells from VHL-disease patients with those found in normal kidney cells from control individuals, to see if somatic mutation rates are increased in VHL-disease patients during aging.


Eligibility Criteria:
Inclusion Criteria:

* Genetic diagnosis of VHL-disease; age (data need to be collected from a population distributed between 25 and 65 years); gender (males and females should be equally represented);

Exclusion Criteria:

* patients with bilateral nephrectomy, in dialysis or kidney transplant; use of nephrotoxic drugs
Pharmacokinetics, Safety and Tolerability of the Preservative-free Fixed Dose Combination of Tafluprost 0.0015% and Timolol 0.5% Eye Drops

The objective of this study is to investigate the pharmacokinetics, safety and tolerability of the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% (FDC) to those of preservative-free tafluprost 0.0015% and timolol 0.5% eye drops in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 45 years
* Good general health
* Meet best corrected ETDRS visual acuity

Exclusion Criteria:

* Significant systemic or ocular disease
* History of eye surgery, including refractive surgery
* Allergy or hypersensitivity to study drug
* Low heart rate (\<50 bpm)
* Clinically relevant low blood pressure
* Asthma
* Bradycardia
* Use of contact lenses within one week prior to screening or during the study
* Clinically significant obesity (body mass index \> 30 kg/m2)
* Blood donation within 2 months prior to screening
* Females who are pregnant or lactating and females not using adequate contraceptives
Health Education vs. Health Education Plus Physical Therapy for Low Back Pain Patients

The primary purpose of this study is to assess the effectiveness of a brief educational program and of an additional program in physical therapy, for the treatment of low back pain in Primary Care of the Spanish National Health Service. This is a controlled, cluster randomized community trial.


Eligibility Criteria:
Inclusion Criteria:

* Consultation for low back pain, with or without referred or radiated pain; no signs of systemic disease or criteria for surgery.

Exclusion Criteria:

* Inability to fill out the questionnaires (blindness, dementia, illiteracy; total habitual prostration;
* Diagnosis of rheumatologic inflammatory disease, fibromyalgia or cancer in last 5 years;
* Suspicion of fibromyalgia.
Evaluation of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease

The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease

This was a Phase 2b, multicenter, randomized, double-masked, placebo controlled study designed to evaluate the safety and efficacy of OC 01 nasal spray in adult subjects with DED. The study randomized 182 subjects, at least 22 years of age, who had a physician's diagnosis of dry eye disease and met all other study eligibility criteria to receive an application of OC-01 or placebo twice daily (BID) for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to Visit 1

Exclusion Criteria:

* Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such as blepharoplasty) in either eye within three months or refractive surgery within twelve months of Visit 1
* Have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with DED are allowed.
* Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)
* Have a known hypersensitivity to any of the procedural agents or study drug components
* Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject
Prevalence of Cytomegalovirus Infection in Patients With Quiescent Ulcerative Colitis

Colitis from reactivation of established cytomegalovirus (CMV) colonization can complicate the clinical course in patients with an acute flare of ulcerative colitis (UC). Accurate and timely detection of active CMV infection or disease with appropriate anti-viral therapy may reduce complications associated with acute UC flare. Limited information is available on the presence of colonic CMV infection in patients with quiescent ulcerative colitis. Prospective studies on factors associated with reactivation of CMV infection during active UC flare and its impact on disease progression are lacking.

The hypothesis of this study are as follows: 1) CMV infection is prevalent in patients with ulcerative colitis irrespective of disease severity; 2) The degree of immunosuppression directly impacts CMV infection status in patients with ulcerative colitis

This is cross sectional study at St. Paul's Hospital, a tertiary academic teaching hospital. Subjects ages 19 or greater with quiescent ulcerative colitis present for routine elective surveillance endoscopy will be invited for the study.

At enrollment, subjects will be evaluated for clinical and endoscopic disease severity using Mayo score. To be eligible for the study, Mayo score must be \<2. Supplemental blood tests, diagnostic test to determine CMV status, physical examination for extra-intestinal manifestation of CMV and inflammatory bowel disease, and surveillance colonoscopy with colonic biopsy will be done.

Patients will be followed longitudinally. Patients will be contacted every three months via their preferred method (telephone or email) until disease flare (clinical partial Mayo Score \> 2) or one year from enrolment. Patients will be asked to contact study coordinator when they are experiencing UC flare.

Eligibility Criteria:
Inclusion Criteria:

* Patients ages 19 or greater with quiescent ulcerative colitis present for routine elective surveillance endoscopy
* At enrolment: clinical partial Mayo score \< 2 prior to endoscopic evaluation
* At endoscopy: endoscopic Mayo score \< 2

Exclusion Criteria:

* Patient age less than 19
* Clinical partial Mayo score at enrollment ≥ 2
* Endoscopic Mayo score ≥ 2
* Overall Mayo score \> 5
* Patients with known current or previous CMV infection
* Patients with HIV, solid organ or bone marrow transplantation, immunoglobulin deficiency, and who are otherwise immunosuppressed for reasons other than treatment of ulcerative colitis, or
* Pregnant patients
NAC Supplementation and Soccer Specific Performance

In this investigation the investigators utilized NAC supplementation to boost GSH availability during an one-week-microcycle consisting of three soccer games, in order to test the hypotheses that: i) antioxidant supplementation may enhance the recovery of performance and physiological stress variables following multiple match-plays and ii) redox status perturbations are critical in regulating the inflammatory response and repair in skeletal muscle, following repetitive exercise-induced muscle injuries.

After exercise-induced muscle microtrauma the thiol/disulfide couple of reduced (GSH) and oxidized glutathione (GSSG) is a key regulator of important transcriptional pathways that control the inflammatory response and recovery of skeletal muscle.

The objective was to examine how thiol-based antioxidant supplementation affects the muscle damage, oxidative stress, inflammatory and immune responses, as well as the level of post-game fatigue and muscle's recovery kinetics in response to three soccer games within a week. Participants were randomly assigned to one of four groups: i) Experimental-NAC \[EXP-NAC, N=10, participated in daily training sessions and three games and received NAC (20 mg/kg/day)\], ii) Experimental-Placebo (EXP-Pla, N=10, participated in daily training sessions and three games and received Placebo), iii) Control-NAC \[CON-NAC, N=10, participated in daily training sessions only and received NAC(20 mg/kg/day)\] and iv) Control-Placebo (CON-Pla, N=10, participated in daily training sessions only and received Placebo). Blood samples were collected at baseline, post-games and daily during recovery. Performance was assessed at baseline and daily during recovery.

Eligibility Criteria:
Inclusion Criteria:

* Participation at elite level (top three division leagues) of soccer competition for at least five years
* Abstained from consumption of performance-enhancing supplements, antioxidant supplements and medications (for at least 6 months before and during the study)
* Participation in at least six two-hour training sessions and one match per week
* Non-smokers

Exclusion Criteria:

* A known NAC intolerance or allergy
* A recent febrile illness
* History of muscle lesion
* Lower limb trauma
* Metabolic diseases
Estimate of the Activity and the Forecast of the Lupus Disease of the Adult by a Transcriptomic Score (STUDY LU-PUCE)

Lupus erythematosus systemic is an auto-immune disease the evaluation of the activity of which remains very difficult because of an heterogeneousness of the clinical and biological symptoms. The aim of this study is to develop objective, specific and not invasive methods of evaluation of the activity and the forecast of the disease by using an analysis of the transcriptome on circulating blood. A transcriptomic analysis will be realized in parallel by the usual clinico-biological follow-up at the patients affected by systemic lupus, while the diagnosis before treatment, then during every revaluation of the disease during the period of the study. The already treated patients can also be included in this study.


Eligibility Criteria:
Inclusion Criteria:

* Lupus disease diagnosed for lupus disease arm
* Signed assent

Exclusion Criteria:

* non-compliance
* pregnancy
* persons without social coverage
Gut Microbiota Changes in Obese Individuals Undergoing Dedicated Lifestyle Modification Programs

The human gut microbiota has become the subject of extensive research in recent years, particularly in regards to the role it plays in obesity. Although lifestyle factors, diet, and lack of exercise contribute largely to this obesity epidemic, there is increasing evidence that the human gut microbiota also influences weight gain.

The investigators hope to learn more information about the change in gut microbiota, especially with regards to those who are successful with weight loss, versus those who don't lose weight, after participating in a lifestyle modification program at the Dan Abraham Healthy Living Center (DAHLC).

The gut microbiome is altered in obesity and is being increasingly studied given its role in energy harvest and fat storage with the hopeful goal of discovering a modifiable intervention to affect obesity and its consequences. Mouse models have already shown that transplantation of an obese microbiota into germ-free mice yields increased adiposity compared to transplantation of a lean microbiota. In humans, initial studies looked at the relative proportion of Bacteroidetes and Firmicutes in obese versus lean individuals and then followed those obese individuals who lost weight on low-calorie diets. The relative proportion of Bacteroidetes was decreased in obese people, and this then increased with weight loss. While certainly provocative, the findings were not consistently reproduced.

Subjects will include members of the Dan Abraham Healthy Living Center (DAHLC) program or the Healthy Living Program (HLP) at Mayo Clinic Rochester, who are seeking advice for weight management concerns.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and above;
* Subjects who are overweight or obese (BMI of 25 or greater);
* DAHLC/HLP eligible members who are able to access DAHLC support services;

Exclusion Criteria:

* Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions;
* Antibiotic use within the past 4 weeks (they can be enrolled after a four week washout period and subsequent use during the 6 month study duration does not exclude them);
* Bowel preparation for colonoscopy within the past week;
* Pregnancy or plans to become pregnant within the study time frame;
* Vulnerable Adults;
* Any other disease(s), condition(s) or habit(s) that would interfere with completion of the study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes;
Peroxisome Proliferator-Activated Receptor-gamma (PPAR-gamma) Agonist in Diabetic End-Stage Renal Disease Patients

To test the hypothesis that PPAR-gamma agonist, rosiglitazone, induces carotid plaque regression in diabetic ESRD patients on maintenance PD via its anti-inflammatory property.

End-stage renal disease (ESRD) patients are at an increased risk of accelerated atherosclerosis and cardiovascular morbidity and mortality. Non-traditional risk factors such as inflammation and insulin resistance have important contributions to accelerated atherosclerosis in ESRD patients receiving long-term peritoneal dialysis (PD). The peroxisome proliferator-activated receptor-g (PPAR-g) is a member of the nuclear receptor family of ligand-dependent transcription factors. Activation of the PPAR-g has been shown in both clinical and experimental studies to have anti-inflammatory and anti-atherosclerotic properties other than insulin-sensitizing effects. Recent study also showed that PPAR-g agonists reduce plaque inflammation by inhibiting the activation of proinflammatory genes responsible for plaque development and growth. Hence, this study aims to examine the effects of PPAR-g activation on the progression of carotid plaque in diabetic ESRD patients receiving long-term PD using high-resolution magnetic resonance imaging (MRI).

Eligibility Criteria:
Inclusion Criteria:

* Diabetic ESRD patients receiving long-term PD treatment, with carotid plaque (defined as focal intima-media thickening \>1mm) present on screening ultrasonography
* Patients who provide informed consent for the study

Exclusion Criteria:

* Patients with systemic inflammatory disease such as systemic lupus erythematosus
* Patients with chronic liver disease or cirrhosis
* Patients with current active malignancy
* Patients with chronic rheumatic heart disease or congenital heart disease
* Patients with poor general condition
* Patients with plan for living related kidney transplant within coming 1 year
* Patients with pre-existing class III/IV heart failure,
* Patients with recurrent hypoglycemia
* Patients already on glitazone treatment
* Female patients with pregnancy
* Patients with contraindications for MRI examination including those with pacemaker or metallic implant.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1356 BS Administered to Healthy Male Subjects

The objective of the current study was to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1356 BS.


Eligibility Criteria:
Inclusion Criteria:

- Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood pressure (BP), Heart Rate (HR), 12-lead Electrocardiogram (ECG)), clinical laboratory tests

* Age ≥21 and Age ≤65 years
* BMI ≥18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

* Any finding of the medical examination (including BP, HR and ECG) deviating from normal and of clinical relevance
* Any evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients and lactose intolerance)
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (more than 60 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of study centre
* Any ECG value outside of the reference range and of clinical relevance including, but not limited to QRS interval \> 110 ms or QTcB \> 450 ms or QT \>500 ms