cyrilzakka/clinical-trials huggingface dataset:
A Bioequivalence Study Of AG-013736 Tablets Under Fed Conditions In Healthy Volunteers

The purpose is to show that 5 mg Form IV tablet of AG-013736 produces similar drug concentrations in plasma compared to 5 mg Form XLI tablet of AG-013736 after oral dosing under fed conditions.

To establish bioequivalence between Form IV and Form XLI of AG-013736 tablets

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 47 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead electrocardiogram (ECG) and clinical laboratory tests)
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs)
* An informed consent document signed and dated by the subject or a legally acceptable representative

Exclusion Criteria:

* Evidence of significant disease of the blood, kidney, endocrine system, lungs, gastrointestinal, heart, liver, psychiatric, neurologic, or allergic (including drug allergies, but excluding season allergies)
* Use of tobacco- or nicotine- containing products (or a positive urine cotinine test).
* Pregnant or nursing females and females of childbearing potential including those with tubal ligation
Identification of Microcirculation and Inflammation After Posterior Stabilization of the Spine

In this project, with unstable vertebral fractures, the microcirculation of the skin and muscle (O2C,Laser-Doppler/White-light -Spectroscopy and contrast-enhanced sonography) will be evaluated in both conventional and in percutaneous minimally invasive technique (XIA versus Mantis) at the thoracolumbar junction.

In this project, with unstable vertebral fractures, the microcirculation of the skin and muscle (O2C,Laser-Doppler/Whitelight-Spectroscopy and contrast-enhanced sonography) will be evaluated in both conventional and in percutaneous minimal-invasive technique (XIA versus Mantis) at the thoracolumbar junction. And after placing a fixator, the inflammatory potency (laboratory chemicals, cytokines, immune status) and the muscular injury (EMG) of acess are examined.

The study is planned as a randomized prospective study. In the study a total of at least 100 patients should be included, 50 with minimally invasive fixation-implantation and 50 patients with conventional procedure.

The radiological imaging (post-surgical control, possibly after mobilization, CT) ist routinely.

The patient outcome is determined using established scores (clinical score, visual analogue scale, SF-12).

The study also indicates by comparing the damage of the microcirculation of the two surgical techniques to make statements on wound healing and muscle blood flow heavily in order to filter out the less complications and tissue-method.

In this research project, the limits in the microcirculation measurement with the O2C and contrast enhanced sonography be established at an early stage to help in future wound healing disorders can be treated so well.

Eligibility Criteria:
Inclusion Criteria:

older than 18 years, fracture in thoracal-lumbal region, deceleration of agreement signed

Exclusion Criteria:

under age, pregnant, pathologic fractures, history of surgery in the examined area, history of metabolic bone disease, soft tissue damage, immunodeficient, polytrauma, history of significant heart or pulmonal diseases or diabetes mellitus
ERADICATE Hp - Treating Helicobacter Pylori With RHB-105

The "test and treat" strategy for treating dyspeptic patients who are H. pylori positive is rapidly becoming the standard of care. This study will test the effectiveness of RHB-105, a new triple therapy to treat H. pylori infection in dyspeptic patients.

This is a, randomized, double-blind, placebo-controlled study of RHB-105 in adult subjects complaining of epigastric discomfort that have been screened and found to be positive for H. pylori infection via 13C Urea Breath Test (UBT) and either fecal antigen test or CLO test.

Eligible subjects will be randomized in a ratio of 1:2 between placebo arm (n=30) and the active arm (RHB-105) (n=60). Subjects will receive study drug for 14 consecutive days. Eradication of H. pylori infection will be determined based on 13C UBT conducted between 28 to 56 days after completion of study drug therapy.

Subjects will be unblinded upon 13C UBT analysis. This will provide timely active therapy to all subjects enrolled in this study. Subjects in the placebo arm will be entitled to receive standard-of-care as prescribed by the treating physician following un-blinding.

Eradication failures (13C UBT-positive) in the active study drug arm will undergo upper endoscopy with sampling for culture and sensitivity testing (to rifabutin, amoxicillin, clarithromycin, and metronidazole). Culture and sensitivity directed therapy as prescribed by the treating physician will be offered to these subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Be ≥18 years of age and ≤ 65 years
2. Have symptoms consistent with dyspepsia of at least two weeks duration (defined as recurrent pain or discomfort centered in the upper abdomen, often with a relation to meals)
3. Be positive for H. pylori by 13C Urea Breath Test (UBT) and also by fecal antigen test
4. Be informed of the nature of the study and provide written informed consent before any study specific procedures are performed (or have a legally authorized representative sign consent)

Exclusion Criteria:

1. Have alarm symptoms/signs (including unexplained anemia \[iron deficiency), melena / hematemesis, anorexia, dysphagia, jaundice, weight loss)
2. Have taken antibiotics in the 4 weeks prior to screening
3. Have taken bismuth containing medications such as peptobismol in the 4 weeks prior to screening
4. Have a history of any previous esophageal or gastric surgery, except for simple closure of perforated ulcer
5. Have a history of gastric outlet obstruction
6. Have a history of hypersecretory state such as Zollinger-Ellison Syndrome
7. Have a history of gastric cancer
8. Have the presence of active gastric and duodenal ulcers or presence of 3 or more active ulcers
Exercise for Adults With Limited Mobility

The purpose of this study is to evaluate the effectiveness of a structured and progressive task-oriented, community based exercise program for older adults who have limitations in mobility and examine whether improvements in mobility and quality of life would be seen following completion at 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Limitations in mobility as evidenced by 6 Minute Walk Test score of \< 499 meters
* Motivation to participate in an exercise program

Exclusion Criteria:

* unable to follow commands
* unstable cardiac status
* greater than minimal assist for mobility
Duration of Antibiotic Therapy in Community - Acquired Pneumonia

The purpose of the study is to assess the efficacy of an individualized approach to duration of antibiotic therapy based on each subject's clinical response compared to a local standard approach in patients coming from the community and who are hospitalized because of a pneumonia.


Eligibility Criteria:
Inclusion Criteria:

Patients will be 18 years old or older and meet all of the following inclusion criteria to be eligible for enrollment into the trial:

1. Diagnosis of pneumonia:

   Evidence of a new pulmonary infiltrate seen on either radiograph or computed tomography of the chest within 48 hours after hospitalization plus at least two among the following: 1) new or increased cough with/without sputum production and/or purulent respiratory secretions; 2) fever (documented temperature -rectal or oral- ≥ 37.8 °C) or hypothermia (documented temperature -rectal or oral- \<36o C); 3) deterioration of oxygenation; 4) evidence of systemic inflammation (such as abnormal white blood cell count -either leukocytosis (\>10,000/cm3) or leukopenia (\< 4,000/cm3) - or increasing of C-reactive protein or procalcitonin values above the local upper limit.

   CAP will be defined as pneumonia occurring in any patient admitted to the hospital coming from the community and who were not hospitalized in the previous 14 days. HCAP will be defined as a community-acquired pneumonia occurring in a patient with any of the following special epidemiological characteristics: patient who was hospitalized for 2 days or more in the previous 90 days; patient coming from a nursing home or extended care facility; patient who received home infusion therapy (including antibiotics) or wound care in the previous 30 days; patient who was on chronic dialysis in the previous 30 days.
2. An appropriate empiric antibiotic therapy for the pneumonia received within 24 hours after admission to the hospital.
3. A clinical stability reached within 5 days after hospital admission, in the absence of any changes of the initial empiric antibiotic therapy.
4. Signed informed consent

Exclusion Criteria:

Patients presenting with any of the following will not be included in the trial:

1. Patients with immunodeficiency, defined as: chemotherapy in the previous 12 months, radiotherapy in the previous 12 months, transplantation, immunosuppressive treatment, hematologic malignancy, AIDS or HIV with CD4 count \< 200, asplenia.
2. Patients with a concomitant infection on admission to the hospital requiring antibiotic therapy (i.e urinary tract infection). The presence of sepsis due to pneumonia will not be considered another concomitant infection.
3. Patients with documented bacteremia due to S. aureus in a blood culture (both methicillin resistant and susceptible S. aureus)
4. Patients with etiology of pneumonia due to fungi, mycobacterium or Pneumocystis jiroveci.
5. Patients hospitalized in the previous 15 days

Inclusion and exclusion criteria for the proposed study will not limit the study cohort on the basis of sex, ethnicity, socioeconomic status or other potentially discriminatory factors.
Safety and PK Study of CC-90003 in Relapsed/Refractory Solid Tumors

The CC-90003-ST -001 trial is a first-in-man, open-label study in subjects with locally-advanced or wide spread cancers to determine if CC-90003 (an oral medication) can be adequately tolerated with minimal side effects.

CC-90003-ST -001 is an open-label, multicenter, Phase 1a study in subjects with locally-advanced or metastatic, solid tumors who are intolerant of, resistant to, or have relapsed after at least one line of therapy and for whom no standard therapy exists. The study will be conducted in two parts: Dose Escalation (Part 1) and Cohort Expansion (Part 2). Subjects may continue CC-90003 until progression of their underlying malignancy, the occurrence of intolerable toxicity, or physician/subject decision to discontinue CC-90003. In Part 1, cohorts of subjects with relapsed or refractory solid tumors will receive increasing doses of CC-90003 in order to assess its safety and tolerability, the maximum tolerated dose (MTD), and PK profile. In Part 2, cohorts of subjects with specific tumors that harbor mutations involving the Mitogen -Activated Protein Kinase (MAPK) pathway will receive CC-90003 at or below the MTD until progression of disease, intolerable toxicity, or physician/subject decision to discontinue CC-90003.

Eligibility Criteria:
Inclusion Criteria:

1. Eligible study subjects in Part 1 and Part 2 must be 18 years or older
2. Eligible study subjects must have histologic or cytologic confirmation of advanced, unresectable or metastatic solid tumors, and have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
3. Eligible study subjects must have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
4. Eligible study subjects must exhibit acceptable liver, bone marrow, renal and cardiac functions as assessed by laboratory tests, ECG and ECHO or MUGA scan.

Exclusion Criteria:

1. Subjects with symptomatic or unstable CNS metastases
2. Subjects with a history of recent (within 28 days) systemic therapy for their underlying malignancy
3. Subjects who have had surgery/radiotherapy within 2 weeks prior to start of study
Esophageal Motility and Airway Defenses Among Infants

Feeding difficulties and airway related consequences contribute significantly to the infant mortality and morbidity. Some of these problems may be dependent on neural control and muscular function. Prematurity, congenital anomalies and perinatal depression represent three important conditions in infants, that may have feeding and airway difficulties.Development of motility of the foregut and the adaptation during normal and disease in developing infants is unclear.

With the aid of small clinical research funding from the NIDDK, in this proposal, we have developed methods to safely evaluate foregut motility in relation to breathing among high risk infants. We are using simultaneous esophageal motility studies, swallowing and respiratory measurements in this evaluation.

Eligibility Criteria:
Inclusion Criteria:

Prematurely born infants, Infants with congenital foregut anomalies, Infants with perinatal asphyxia, Ability to maintain vital signs at study,

Exclusion Criteria:

No contraindication to enteral feeding
Treatment of Fever Due to Malaria With Ibuprofen

Drugs to treat fever are widely used in children with fever. But there is a controversy about the benefit of reducing fever in children with malaria. Ibuprofen is often used to treat malarial fever. This study evaluates the capacity of ibuprofen to reduce fever in malaria. The effect of ibuprofen on fever compared to only mechanical measures is investigated in children with malaria.

Fever is the most apparent clinical manifestation of Plasmodium falciparum infection during the acute phase. The role of fever in defence against malaria or in other infectious diseases remains unclear. However, it has been shown that febrile temperatures inhibit the growth of P. falciparum in vitro.

Antipyretic drugs are commonly and widely used to treat malarial fever in endemic areas. There is however a controversy about the benefit of reducing fever in children with malaria. Data from Gabon have revealed that neither paracetamol, nor naproxen or metamizol - antipyretics often used in this area - had an effect on fever clearance time. Worryingly, paracetamol increased parasite-clearance times (i.e. inhibited clearance of parasites) and decreased significantly the production of oxygen radicals and tumour necrosis factor (TNF), mechanisms of the innate immune response, pivotal to combat infections.

Another antipyretic drug often used to treat malarial fever in endemic areas is ibuprofen. However, the rationale of its use and its capacity of reducing fever due to P. falciparum infections has never been proven in this area.

Comparison: The effect of ibuprofen plus mechanical fever "treatment" (continuous fanning, tepid sponging, and cooling blankets) is compared to mechanical treatment alone to treat fever in children with malaria.

Eligibility Criteria:
Inclusion Criteria:

* Uncomplicated falciparum malaria
* Asexual parasitaemia between 20,000 and 200,000/µL
* Fever with temperature above 38 °C or history of fever during the preceding 24 hours
* Informed consent

Exclusion Criteria:

* Effective anti-malarial treatment for the present attack
* Antipyretic use within 6 hours of presentation
* Contraindications to the use of ibuprofen (history of asthma, dyspeptic symptoms, gastro-intestinal bleeding, or allergy to ibuprofen)
* Mixed plasmodial infection
* Haemoglobin \< 7 g/dL
* Packed-cell volume \< 20%
* White cell count \> 16,000/L
* Platelet count \< 40,000/µL
* Schizontaemia \> 50/µL
* Impaired consciousness
* Convulsions or history of convulsions
* Concomitant diseases masking assessment of response
Cardiovascular Outcomes in the VA's Rheumatoid Arthritis(VARA) Population

Rheumatoid arthritis (RA) is a symmetric, peripheral polyarthritis of uncertain etiology that can lead to joint deformity and destruction. However, the effects of RA are not confined simply to joint involvement. Virtually every organ system can be affected by RA if left untreated. Of particular note is RA's affect on the cardiovascular system. RA patients have a reduced lifespan compared to the general population primarily due to an increased cardiovascular disease burden (1). Recently, RA has been linked to the development of preclinical atherosclerosis in the carotid arteries as measured by ultrasonography (2). Women with RA have also been shown to have an increased incidence of nonfatal myocardial infarctions (3). Despite these studies showing the effects of RA on the cardiovascular disease burden of those who are afflicted, no study to date has compared the number of cardiovascular events in a large RA patient population to a risk factor and age matched control group. Consequently it is the goal of this study to determine whether the cardiovascular event ratio in an RA patient cohort exceeds an age and risk factor matched cohort of non-RA patients. This study will also attempt to ascertain whether specific cardiovascular risk factors contribute to the cardiovascular morbidity and mortality associated with RA and if any standard cardiovascular medicines disproportionately contribute to patient outcome.

Hypothesis: Given the increased cardiovascular disease burden associated with RA patients they are likely to suffer from a statistically significant increased risk of cardiovascular events when compared to an age and risk factor matched cohort.


Eligibility Criteria:
Inclusion Criteria:

* Patient included in the VA Rheumatoid Arthritis database previously, who by definition will meet criteria for RA.
* Control subjects will not carry the diagnosis of RA.
Benazepril for Advanced Chronic Renal Insufficiency

The purpose of this study is to further determine whether benazepril, could safely slow the progression of renal dysfunction in non-diabetic patients with advanced renal insufficiency.


Eligibility Criteria:
Inclusion Criteria:

1. serum creatinine concentration 1.5-5.0 mg/dL (133-442 µmol/L)
2. creatinine clearance 20 to70 mL/min/1.73 m2, with variations of less than 30 percent in the three months before the screening evaluation
3. non-diabetic renal disease
4. persistent proteinuria (defined as urinary protein excretion greater than 0.3 g/day for three or more months without evidence of urinary-tract infection or overt heart failure \[New York Heart Association class III-IV\]).

Exclusion Criteria:

* immediate need for dialysis; treatment with corticosteroids, non-steroidal anti-inflammatory drugs or immunosuppressive drugs; renovascular disease; myocardial infarction or cerebrovascular accident in the year preceding the trial; connective-tissue disease; obstructive uropathy.
Green Tea Intake for the Maintenance of Complete Remission in Women With Advanced Ovarian Carcinoma

Green tea is extracted from steam treated leaves, allowing the preservation of catechins, the active elements of the infusion. Catechins are recognized for their anti-cancer activity. Catechins act on the capacity of cancer to disseminate to other organs because of their anti-protease action. Proteases are proteins capable of digesting the cancer environment and facilitating the progression of cancer cells to blood vessels which will bring them to distant organs. We know that ovarian cancer responds well to the initial treatment of chemotherapy but tends to recur rapidly. We intend to provide green tea with higher concentrations of catechins to women with complete remission of their ovarian cancer in an attempt to delay cancer relapse. We also intend to identify, with molecular technologies, the proteases involved in ovarian cancer recurrence and response to catechins. Our objective is to test the hypothesis that green tea intake may delay ovarian cancer recurrence and to develop tools to predict which women will best benefit of the addition of green tea to their initial treatment.


Eligibility Criteria:
Inclusion Criteria:

* patients with ovarian serous carcinoma FIGO stage III or IV
* patients showing complete response after oncological surgery and chemotherapy (paclitaxel-carboplatin, minimum 5 cycles, maximum 8 cycles), complete response being defined as 1) a negative complete physical examination 2) Serum CA-125 levels inferior to 35 U/mL 3) no evidence of diseased assessed by abdomino-perineal CT-scan
* patients refraining from drinking tea other than provided by the study
* patients who may absorb liquids orally
* patients without any other malignancy (except for non-melanoma skin cancer)
* patients not involved in an other study
* patients who signed up informed consent form.

Exclusion Criteria:

* exclusion criteria are implicit from inclusion criteria.
In-office Bleaching With a 2-day Interval Between Sessions: Tooth Sensitivity

The calcium containing 35% hydrogen peroxide gel employed in this study can be re-applied 2 days after the first bleaching session without increasing the bleaching-induced tooth sensitivity

The in-office bleaching uses 35% hydrogen peroxide gel which is applied in 2 to 3 sessions usually with one week interval between sessions, without a scientific and plausible reason for this recommendation (. The aim of this study was to evaluate the tooth sensitivity (TS) risk using a shorter interval between clinical sessions. Methods: In this randomized, single-blind study, 40 young patients with color C2 or darker were selected and randomly divided in two groups. In the 7-day group, two bleaching sessions with a 35% hydrogen peroxide gel (Whiteness HP Blue Calcium - FGM) were performed with a one-week interval and in the 2-day group, the same protocol was performed but with a 2-day interval. TS was recorded on a 0-10 visual analog scale up to 48 h after bleaching. The color evaluation was performed at baseline and 30 days after bleaching with a value-oriented shade guide and a spectrophotometer. The absolute risk of TS (%) was evaluated by Fisher´s exact. The TS intensity was evaluated by two-way repeated measured ANOVA and color changes (ΔSGU and ΔE) were evaluated by Student´s t-test (alpha = 5%).

Eligibility Criteria:
Inclusion Criteria:

The participants should have:

At least six maxillary and mandibular anterior teeth caries-free. Without restorations on the labial surfaces. The central incisors should be C2 or darker according to a value-oriented shade guide (Vita Lumin).

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Exclusion Criteria:

Pre-existing anterior restorations. Pregnant/lactating. Severe internal tooth discoloration (tetracycline stains, fluorosis, pulpless teeth).

Taking any drug with anti-inflammatory and antioxidant action. Bruxism habits or any other pathology that could cause Tooth Sensbility (such as recession, dentine exposure).

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