cyrilzakka/clinical-trials huggingface dataset:
A Study With LY293111, Gemcitabine and Placebo in Patients With Pancreatic Cancer

The purpose of this study is to determine the effectiveness and side effects of LY293111 given in combination with gemcitabine in patients with pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Adenocarcinoma of the pancreas that is locally advanced or metastatic and not amenable to resection with curative intent
* Tumor that can be measured by x-ray or scan
* Adequate organ function

Exclusion Criteria:

* Inability to swallow capsules
* Documented brain metastases
* Prior chemotherapy or biological therapy for this disease
Effect of Long-term Oxygen Therapy on Exercise Capacity and Quality of Life in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension

In this randomized-controlled, cross-over trial the investigators test the effect of long-term oxygen therapy (\> 16h/day) given for 5 weeks with a wash-out period between phases of 2 weeks on exercise performance and quality of life and many physiological parameters in patients with pulmonary arterial and chronic thromboembolic pulmonary hypertension.


Eligibility Criteria:
Inclusion criteria:

- Adult patients with established diagnosis of pulmonary arterial or chronic thromboembolic pulmonary hypertension (class I and IV according to the latest WHO classification scheme of Dana Point 2008) on optimized medical therapy and in stable condition for at least 4 weeks, who desaturate in the 6 minute walking test by =4% to values \<92%.

Exclusion criteria:

* Patients in unstable conditions requiring frequent therapeutic adaption
* pregnant women
* patients with pulmonary venous hypertension due to left heart diseases
* patients with relevant concomitant lung disease and severe daytime hypoxemia
Conditioned Pain Modulation in Localized vs Widespread Chronic Low Back Pain

This study aims to compare function of the body's endogenous pain modulation system between people with localized low back pain versus widespread body pain. Endogenous pain modulation refers to the body's natural ability to inhibit one pain stimulus by applying a second pain stimulus. This study will assess pain inhibition by measuring pressure pain thresholds at the low back before and during cold water hand immersion. The researchers hypothesize that those with widespread body pain will have worse functioning of pain inhibition compared to those with localized low back pain only. The results may provide insights into personalized chronic pain management approaches.

Chronic low back pain (CLBP) is highly prevalent worldwide. Impairments in conditioned pain modulation (CPM) have been documented in CLBP populations. CPM refers to endogenous pain inhibition, where one noxious stimulus inhibits pain from a second noxious stimulus. This relies on descending inhibitory pathways. However, it is unknown whether CPM alterations differ between individuals with localized versus widespread mechanical pain hypersensitivity. The aim of this cross-sectional quantitative sensory testing study is to compare CPM function between localized and widespread CLBP subgroups. A sample of 75 adults with CLBP of at least 3 months duration will be recruited from a chronic pain clinic. Based on pressure pain threshold mapping at the low back and distal sites, participants will be classified as having localized or widespread mechanical hyperalgesia.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-60 years
* Chronic LBP \>3 months
* Average LBP intensity ≥4/10

Exclusion Criteria:

* Known LBP pathologies
* Previous lumbar surgery
* Neuropathic LBP
* Comorbid generalized pain conditions
An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer

The purpose of this study is to determine whether Nivolumab, in combination with other therapies, is effective in patients with advanced Non-Small Cell lung cancer


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Advanced Non Small Cell Lung Cancer (NSCLC)
* Eastern Cooperative Oncology Group (ECOG) Performance status of ≤ 1
* Life expectancy of at least 3 months from most recent chemotherapy or immunotherapy treatment
* Must have at least 1 lesion with measurable disease

Exclusion Criteria:

* Subjects with certain mutations that have not been treated with a targeted therapy prior to enrollment
* Subjects who need daily oxygen therapy
* People with autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply
Metabolic Cost of Kettlebell Training

This study aims at investigating the metabolic cost of several fundamental exercises with Kettlebell. Kettlebell training has become a popular training modality that is efficiently used to improve cardiovascular status and physical performance. Despite its widespread use and popularity the metabolic cost of exercises using kettlebell remains to be elucidated. Therefore, the metabolic cost of various fundamental exercise with kettlebell will be determined to aid the planning of exercise training programs.

Ten healthy young adults will be assigned to this study. Participants will initially undergo a baseline assessment of their anthropometrics, body composition (by DXA), resting metabolic rate (RMR), cardiorespiratory fitness (VO2max), muscular strength \[maximal strength (1RM) and muscular endurance\] and functional capacity. After baseline screening, participants will execute in different days (one exercise per day) one set of each of the following 7 exercises: (1) plank with kettlebell pass, (2) swings, (3) overhead squat-thrusters, (4) lunges with motion hands, (5) single leg deadlift, (6) wood chop και (7) snatch, in two different conditions: (i) 30 sec and (ii) 45 sec exercise duration, in a random order. Prior to each exercise resting heart rate, blood lactate concentration, oxygen consumption and rate of perceived exertion will be recorded. Heart rate and oxygen consumption (through portable gas analyzer) will be continuously monitored during the exercise and after the end of it, until the oxygen consumption reach the pre-exercise values (excess post-exercise oxygen consumption). Blood lactate and rate of perceived exertion will be reassessed post-exercise.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-35 years
* Physically active individuals
* Free of chronic diseases
* Free of musculoskeletal injuries
* Nonsmokers

Exclusion Criteria:

* Chronic disease
* Musculoskeletal injury
* Consumption of alcohol, caffeine and any type of ergogenic supplement during the study
Use of Onepiece Suit or Forced Warm Air for Perioperative Temperature Conservation.

To study if a one piece body suite (T-balance, Telespro, Finland) is equally effective in maintaining peri-operative body temperature as forced air warming, during open low-back surgery of medium duration.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1-3
* Approved consent
* Expected duration of open back surgery of 60-120 min
* Prestudy core temperature (oral) of at least 36 degrees C

Exclusion Criteria:

* Known diabetes mellitus
* Any known illness or use of pre-op drugs which may interfere with normal temperature regulation
* Body mass index less than 17 or more than 35
* Pregnancy
* Any contraindication for warming device or temperature monitor
Optimizing Screening for Cervical Cancer Among Women Living With HIV in the Dominican Republic

This study compares different screening approaches to detect abnormal cell growth on the cervix that could be an early sign of cervical cancer. The lesions are caused by an infection of human papillomavirus, also called HPV. Using new methods to detect HPV may help doctors find ways to improve cervical cancer screening for women living with human immunodeficiency virus (HIV) in the Dominican Republic and in other countries.

OUTLINE:

Participants participate in three annual interviews and clinical exams that last approximately 2 hours. Study participants provide blood, urine, and swab samples from the cervix, anus, and vagina and receive a pelvic exam. Any positive results are followed up in the study clinic.

Eligibility Criteria:
Inclusion Criteria:

* Women ages 25 - 49 years old will be eligible to participate in the study
* Women living with HIV who have an intact cervix
* Intent to reside in the Santo Domingo area
* Ability to attend routine study visits at IDCP for at least 24 months during the study. If women report that they anticipate relocating in the subsequent 24 months or anticipate difficulty attending study visits they will not be eligible
* Ability to understand the study timeline and procedures and the willingness to complete the informed consent process are also inclusion criteria

Exclusion Criteria:

* Women with a prior diagnosis of cervical cancer or a history of treatment for cervical precancerous lesions (CIN2+) will be excluded
* Women with significant physical, mental, or social conditions that would limit participation with study procedures will not be eligible for the study
* Women who are pregnant or report an intent to become pregnant in the subsequent 3 months will not be eligible for the study
* Women who have no history of vaginal sexual exposure will not be eligible for the study
Comparing Two Pneumococcal Vaccines in Adults With Chronic Obstructive Pulmonary Disease

Pneumococcal disease is a serious bacterial infection that can affect different parts of the body, including the lungs. People with chronic illnesses, such as chronic obstructive pulmonary disease (COPD), have a greater risk of developing pneumonia and meningitis as a result of pneumococcal disease. This study will compare the immune response to two types of pneumococcal vaccines in adults with COPD.

Individuals who are infected with the Streptococcus pneumoniae bacteria may develop pneumococcal disease, a serious disease that kills more people in the United States than all other vaccine-preventable diseases combined. Individuals with COPD, characterized by breathing difficulties due to damaged and obstructed lung airways, may have an increased risk of developing serious complications from pneumococcal disease, including pneumonia and meningitis. Currently, there are two types of pneumococcal vaccines available. The pneumococcal capsular polysaccharide (CPS) vaccine, known as Pneumovax, is typically given to adults 65 years of age or older and to any individuals with a serious health condition, including heart disease, lung disease, and diabetes. The diphtheria protein-conjugated vaccine (PCV7), known as Prevnar, is typically given to infants; however, adults who receive this vaccine may also have a favorable response. The purpose of this study is to compare the immune response to the Pneumovax and Prevnar vaccines in adults with COPD.

This study will enroll adults with mild to moderate COPD. Participants will be randomly assigned to receive either the Pneumovax or Prevnar vaccine. This will involve one or two injections. Blood collection will occur during study visits at Months 1, 12, and 24. Study researchers will contact participants by telephone at Months 6 and 18 to document any pneumococcal infections and any additional pneumococcal vaccinations.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
* Post-bronchodilator forced expiratory volume at one second

  /forced vital capacity (FEV1/FVC) level less than 70%
* Ten or more pack-years of smoking
* Willing to make return visits to the study clinic and accept telephone contact
* Last pneumococcal vaccination occured at least 5 years prior to study entry

Exclusion Criteria:

* Asthma
* Sensitivity to pneumococcal vaccine
* Known bleeding disorder, or requires long-term anticoagulation therapy
* Presence of chronic disease that may impair pneumococcal vaccine response
* Acute illness requiring antibiotics in the month prior to study entry
* Medical condition that makes survival for 24 months following study entry unlikely
* Pregnant
Evaluation Of Bacillus Clausii In Treatment Of Acute Diarrhea In Latin American Children

Primary Objective:

To demonstrate the effectiveness of treatment with Bacillus clausii probiotic strain (Enterogermina) in combination with oral rehydration therapy (ORT) for a period of 5 days, in the duration of acute community-acquired diarrhea in Latin American children.

Secondary Objectives:

To evaluate the clinical safety of Enterogermina in acute diarrhea in children and to demonstrate its effectiveness on stool frequency, stool consistency, and number of vomiting episodes.

To evaluate parent's overall global assessment. To evaluate the safety and effectiveness of Enterogermina in norovirus acute gastroenteritis (AGE).

The maximum duration of study participation for each patient can be 10 days.

Eligibility Criteria:
Inclusion criteria:

Infants or children with acute community-acquired diarrhea (≥3 liquid or watery stools occurring in a 24-hour period):

* with less than 48 hours duration
* aged between 6 months and 5 years of age
* whose parents or legal guardians have given their written informed consent
* with clinical indication for ORT per formula of World Health Organization

Exclusion criteria:

Infants or children with:

* presence of blood, pus, or mucus in stools
* severe dehydration
* untreatable vomiting
* antibiotics indication for the treatment of this acute diarrhea;
* hospitalization
* expected hospitalization for the next hours due to the poor clinical conditions
* treatment with antibiotics, probiotics, or prebiotics within a period of 2 weeks before enrolment (the use of probiotics and prebiotics in dairy food such as yoghurt, cheese, milk prior to the study is permitted)
* previous use (within 48 hours) of kaolin, pectin, bismuth subsalicylate, racecadotril, loperamide, atropine and other anticholinergic agents
* indication of any other ORT different from the one prescribed in the study
* chronic diseases including chronic diarrhea
* immunodeficiency (acquired or congenital immunodeficiency)
* other infectious comorbid conditions
* known hypersensitivity to Bacillus clausii (Enterogermina) or other probiotics
* parent/legal guardian who, in the opinion of the Investigator, is unable to complete the patient diary or bring the child for the follow-up visit
* participation in another clinical trial in the last 3 months prior to the start of the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Assessing of Tooth Sensitivity Using Ibuprofen Before in Office-tooth Bleaching

Ibuprofen has been recognized as anti-inflammatory and analgesic. The purpose of this study is to determine the effect of ibuprofen 400 mg on tooth sensitivity (TS) caused by in-office bleaching.

Methods: 30 health adults who received either placebo or ibuprofen. The drugs were administered 1 hour prior to the bleaching and will be prescribed 5 doses every 8 hours during 48 hours. For bleaching will be used 35% hydrogen peroxide gel. The tooth sensitivity will be recorded for up and lower arc on two scales: VAS (visual analogic scale) and 0-4. The shade evaluation will be performed before and 30 days after bleaching with visual shade guide and spectrophotometer.

Background: Ibuprofen has been recognized as anti-inflammatory and analgesic. The purpose of this study was to determine the effect of ibuprofen 400 mg on tooth sensitivity (TS) caused by in-office bleaching.

Methods: A triple-blind, parallel design, randomized clinical trial will be conducted on 30 health adults who received either placebo or ibuprofen. The drugs will be administered 1 hour prior to the bleaching and a every eight hours during 48 hours. For bleaching used 35% hydrogen peroxide gel. The TS will be recorded for up and lower arc on two scales: VAS and 0-4. The shade evaluation will be performed before and 30 days after bleaching with visual shade guide and spectrophotometer. The % of patients that reported TS at least once during treatment and the TS intensity will be evaluated by Fisher's and Mann-Whitney tests, respectively. The color changes will be evaluated by repeated measures ANOVA.

Eligibility Criteria:
Inclusion Criteria:

* patients included in this clinical trial were:
* at least 18 years old.
* had good general and oral health.
* the participants should have eight caries-free maxillary and jaw anterior teeth and without restorations on the labial surfaces.
* the central incisors should be shade C2 or darker.

Exclusion Criteria:

* participants that had undergone tooth-whitening procedures.
* presenting anterior restorations.
* pregnant/lactating.
* with severe internal tooth discoloration (tetracycline stains, fluorosis, pulpless teeth).
* taking any kind of medicine, bruxism habits or any other pathology that could cause sensitivity (such as recession, dentine exposure).
* participants that reported some earlier or present health problems in stomach, heart, kidney and liver, or participants using any continuous drug with anti-inflammatory and antioxidant action were excluded from the study.
SMART - Systems Medicine of Heart Failure

The onset and course of heart failure (HF) is triggered by a complex regulatory network that includes stressors (pressure overload by individual anatomic hemodynamic settings), intrinsic (genes), environmental (regulating epigenetics), and modifying factors (such as hor-mones and the immune system). SMART aims to establish individualized strategies for the prevention and management of HF by early detection of the physiological, genomic, proteo-mic and hemodynamic mechanisms that lead from onecommon cause of ventricular dysfunction (pressure overload) to maladaptive remodelling and irreversible HF. To cope with the complexity of HF, SMART will interrelate models describing the interplay between ge-nome, proteome and cell function, regulating hormones, tissue composition and hemody-namic whole organ function up to a whole body description of a patient and patient cohorts. The ultimate goal is to demonstrate proof-of-concept tools for predicting disease evolution and efficacy of treatment in a given patient. To achieve this task SMART will apply

* A modelling framework that couples multi-scale mechanistic models with in-depth genome/proteome, cell physiology and whole organ (biomechanical and fluid dynamic) models
* Subsequently, investigate methods validity and relevance for "quantitative prediction" of treatment outcome in a clinical proof-of-concept trial (demonstrator) of patients with aortic valve desieases.


Eligibility Criteria:
Inclusion Criteria:

* Aortic Valve Stenosis

Exclusion Criteria:

* coronary heart disease
Use of the Scolioscan for Quantitative Evaluation of Spinal Deformity - A Validity Study on Patients With Scoliosis

The purpose of the study is to investigate the validity of Scolioscan for quantitative assessment of curve severity in scoliosis using x-ray radiographs as the gold standard.

Scoliosis is a three dimensional spinal deformity, in both the coronal plane, sagittal and transverse planes. Quantitative assessment of curve severity in scoliosis is important for patient management. At present, Cobb angle measurement in the frontal plane using standing postero-anterior X-ray radiograph is the gold standard for scoliosis evaluation. Taking x-ray involves irradiation and is not without risk especially over repeated exposures for follow-up visits. With advancement of ultrasound technology which is radiation-free and noted to be useful as a tool for musculoskeletal imaging, an ultrasound system designed for evaluation of spinal deformity called Scolioscan has been developed. It comprises of a freehand 3D ultrasound imaging system with an enhanced frame structure for supporting the patient to maintain the posture during scanning and a software for measuring curve deformity in terms of Cobb angles. Previous studies on validity of ultrasound assessment for back deformity involved a pilot group of subjects. Based on these promising pilot results, we plan to carry out a formal study to investigate the validity of Scolioscan for quantitative assessment of curve severity in scoliosis using x-ray radiograph as the gold standard for comparison.

Eligibility Criteria:
Inclusion Criteria:

* Scoliosis patients between 8-40 years old
* Patients with body mass index (BMI) \<23 kg/m2
* Patients with standing height between 1 m - 2 m

Exclusion Criteria:

* Pregnant women or women after pregnancy before return of the menstrual period.
* Subjects with skin disease such as skin cancer, psoriasis or a history of skin disease
* Subjects with fracture or wound that affect application of the probe of Scolioscan during scanning
* Subjects with Ferromagnetic implants
* Subjects with pacemakers, implanted pain modulators, implanted insulin delivery systems, cochlear implant, and any defibrillator
* Subjects with surgery done for the spine
* Subjects with winged scapula or other irregularity of back contour that precludes satisfactory skin contact of the machine probe during the scanning procedure
* Subjects who cannot stand steadily on the device during the examination
* Subjects with allergy to aqueous gel used for ultrasound scanning
Rituximab Combined With ESHAP in Patients With Relapse or Refractory Diffuse Large B Cell Lymphoma (DLBCL)

The purpose of this study is to evaluate the efficacy and toxicity of Rituximab combined with ESHAP (etoposide, methylprednisolone, cytarabine, and cisplatin) in the patients with diffuse large B cell lymphoma (DLBCL).

The salvage therapy in the patients with DLBCL is still controversial. The investigators conducted this study to evaluate the efficacy and tolerability of Rituximab combined with ESHAP in the patients with DLBCL. The patients enrolled were defined to be relapsed or refractory after the first-line chemotherapy like CHOP or other CHOP-like regimens.

Eligibility Criteria:
Inclusion Criteria:

* Age range 18-70 years old
* Histological confirmed diffuse large B cell lymphoma
* ECOG performance status no more than 2
* Life expectancy of more than 3 months
* Relapse or refractory after the first-line chemotherapy of DLBCL
* No evidence of bone marrow involvement
* Normal laboratory values: hemoglobin \> 8.0g/dl, neutrophil \> 1.5×109/L, platelet \> 80×109/L, serum creatine \< 1× upper limitation of normal(ULN), serum bilirubin \< 1× ULN, ALT and AST \< 1.5× ULN

Exclusion Criteria:

* Pregnant or lactating women
* Serious uncontrolled diseases and intercurrent infection
* The evidence of CNS metastasis and bone marrow involvement
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* History of allergic reaction/hypersensitivity to rituximab
The TRICURE EU Pivotal Study

Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System

The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)
* Institutional Heart Team evaluates patient as being at increased operative risk

Exclusion Criteria:

* Patient in need of emergent intervention
* Patient who is hemodynamically unstable
* Anatomical contraindications for implantation with study device
* Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet