cyrilzakka/clinical-trials huggingface dataset:
A Randomized Clinical Trial of Home-based Exercise Combined With a Slight Caloric Restriction on Obesity Prevention Among Women

The study investigated the effectiveness of home-based exercise combined with a slight caloric restriction on weight change during 12 months in non-obese women. In addition the investigators evaluate the effects of baseline insulin resistance on modulation of weight change.

A randomized clinical trial with a factorial design was conducted from 2003 to 2005. Two hundred three middle-aged women (Rio de Janeiro/Brazil), 25-45 years, were randomly assigned to one of two groups: control (CG) and home-based exercise (HB). The HB group received a booklet on aerobic exercise that could be practiced at home (3 times/week - 40 min/session), in low-moderate intensity, during 12 months. Both groups received dietary counseling aimed at a slight energy restriction of 100-300 calories per day.

The HB experienced a greater weight loss in the first 6 months (-1.4 vs. -0.8 kg; p=0.04), but after 12 months there was no differences between groups (-1.1 vs. -1.0; p=0.20). Of the serum biochemical markers, HDL-cholesterol showed major change, with an increase at month 12 of 18.3 mg/dl in the HB compared to 9.5 in the CG (p\<0.01). At baseline the non-IR group (n=121) compared to IR (n=64) had similar values of BMI (26.7 vs. 26.3 p=0.21), but statistically significant lower values of waist, glucose, insulin and HOMA-IR, as expected. When the group non-IR and IR were further stratified by GI diet, there were no differences according to diet in both groups. Women classified as IR at baseline had greater weight loss after 12 months of follow-up (-1.62 kg vs. -1.08 kg; p=0.01), and HB exercise helped to reduce weight only among NIR women (-1.51 vs. -0.68; p=0.04); no differences were observed between intervention groups for IR women (-1.54 vs. -1.66; p=0.24). There were no differences between IR and NIR groups for lipid profile after adjustment for weight changes. During follow-up, changes were more pronounced among those women in the high GI diet. These differences were statistically significant for weight and BMI and were greater among the IR compared to the non-IR. Changes in HOMA-IR after 3 months of follow-up were different comparing non-IR with IR at baseline. The IR had a reduction in the HOMA-IR, whereas in the non-IR this value increased (-0.73 vs. +0.37; p=\<0.001). Also this reduction was greater among high compared to low GI diet (p=0.04).


Eligibility Criteria:
Inclusion Criteria:

Non-obese women aged 25-45 years

Exclusion Criteria:

Physician-diagnosed thyroid disease or diabetes or who were menopausal or any other disease that could be influenced by intervention
Study Of The Safety And Pharmacokinetics Of CE-326,597 In Patients With Asymptomatic Gallstones

The study is designed to assess whether repeated dosing with CE-326,597 will cause patients with asymptomatic gallstones (as detected on screening abdominal ultrasound) to become symptomatic. In addition, the study will characterize the pharmacokinetics of CE-326,597.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index between 30-40 kg/m2, inclusive
* Evidence of asymptomatic cholelithiasis on screening abdominal ultrasound

Exclusion Criteria:

* Patients with unstable medical conditions, such as diabetes, stroke, heart attack.
* Females of childbearing potential or those who may be pregnant or breast feeding.
* Patients with inflammed gallbladder, evidence of stones in bile ducts on screening abdominal ultrasound, history of symptoms indicating active gallbladder disease or gallbladder removal.
Evaluation and Validation of Endogenous Markers for the Assessment of CYP3A Activity in Korean Healthy Subjects Using Metabolomics

The study objective is to evaluate and validate of endogenous markers for the assessment of CYP3A activity in Korean healthy subjects using metabolomics.

In part 1, total 75 healthy subjects (males and females) will be enrolled. In part 2, total 25 healthy female subject aged 20-45 years will be enrolled. In both part A and B, subjects will be administered midazolam I.V. 1 mg.


Eligibility Criteria:
Inclusion Criteria:

* Age: Between 20 to 80 years of age, inclusive
* Weight: Between 45 to 95 kg, within 17 - 28 of Body Mass Index
* Subject who agree contraception during the study
* Subject who are reliable and willing to make themselves available during the study period, are willing to follow the study protocol, and give their written informed consent voluntarily

Exclusion Criteria:

* History of hypersensitive reaction to medication (midazolam, ketoconazole, rifampicin)
* History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease history or evidence of drug abuse
* A subject whose lab test results are abnormal A subject whose systolic blood pressure is over 140 mmHg or below 90 mmHg and diastolic blood pressure is over 100 mmHg or below 50 mmHg
* Presence or history of drug abuse or positive result in urine drug screening test
* Blood donation during 2 months or apheresis during 1 month before the study Use any prescriptive medication
* Use of alcohol over 21 units/weeks
* Smoker who smoke more than 10 cigarettes per day
* Participation in clinical trials of any drug within 60 days prior to the participation of the study
* Use of grapefruit juice within 1 week before first dose
* Use of caffeine drink within 3 days before first dose
* Subject pregnant or breast-feeding
* Judged to be inappropriate for the study by the investigator
A Study to Evaluate the Efficacy, Safety and Immunogenicity of Leucostim® Versus Neupogen® in Breast Cancer Patients

A study to compare the efficacy, safety and immunogenicity of Leucostim® to those of Neupogen® in patients with breast cancer intended to be treated with TAC regimen as a myelosuppressive chemotherapy.

TAC regimen (docetaxel, doxorubicin and cyclophosphamide) is recommended for the adjuvant treatment of breast cancer patients. The TAC regimen is known to lead to significant hematological toxicity and induces febrile neutropenia with a rate \> 20%. The use of primary G-CSF prophylaxis with the TAC regimen is recommended by guidelines. e.g., by the European Organisation for Research and Treatment of Cancer as well as by the guideline on myeloid growth factors of the National Comprehensive Cancer Network.6,7 This study is to compare the efficacy, safety and immunogenicity of Leucostim® to those of Neupogen® in patients with breast cancer intended to be treated with TAC regimen as a myelosuppressive chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Willing to provide a written informed consent
2. Men or women ≥ 18 and ≤ 70 years of age
3. Histologically or cytologically confirmed breast cancer (Stage II to Stage IV)
4. Be scheduled to receive TAC regimen as adjuvant therapy
5. Subjects who meet the conditions at screening test as follows;

   * Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
   * Platelet Count ≥ 100,000/mm3
   * ECOG Performance Status : 0\~2
6. Adequate renal function (Creatinine ≤ 1.5 x ULN at screening test)
7. Adequate hepatic function at screening test (Total bilirubin/AST/ALT ≤ 1.5 x ULN, ALP ≤ 2.5 x ULN at screening test)

Exclusion Criteria:

1. Prior chemotherapy experiences
2. Prior bone marrow or stem cell transplantation
3. History of treatment with hematopoietic growth factors (e.g. G-CSF, peg-G-CSF, erythropoietin)
4. History of prior malignancy other than breast cancer or surgically cured malignancies within 5 years of informed consent date
5. Participation in any other clinical study within 4 weeks of informed consent date or planning to simultaneously participate in another clinical study
6. Currently receiving radiation therapy or having completed radiation therapy within 4 weeks of informed consent date
7. Active infection which may require systemic antimicrobial or antiviral therapy during the study (e.g. ANC ≥ 12,000/mm3 or Body Temperature \> 38.2 degrees C (100.8 degrees F))
8. History of systemic antibiotic use within 72 hours prior to chemotherapy
9. History of hypersensitivity to the investigational product, components or similar products
10. HIV positive
11. Pregnant or lactating women, or women of child-bearing potential who are not willing to follow a reliable and effective contraceptive measure during the course of the study and for at least one month after the completion of the study
12. Any other cases that is considered by the investigator as an exclusion
Muscle Function and Its Biological and Physiological Determinants in Sickle Cell Disease

Background : Sickle cell patients have profound remodeling of their muscle microcirculation networks with signs of amyotrophy. However, the consequences of these muscle alterations on the functional status of muscles are unknown. In addition, whether the poor physical fitness of sickle cell patients can be attributed, at least partly, to an hypothetical muscle dysfunction has never been tested.

Purpose : this study will compare the muscle function of legs between sickle cell patients (SS and SC genotypes) and healthy individuals (AA genotype) before, during and after a short localized muscle endurance exercise.

Abstract : Very recently, a study reported large differences between the muscle microcirculation networks of sickle cell patients compared to healthy individuals with decreased capillary density and higher proportion of large capillaries in the former population. In addition, the same study showed signs of amyotrophy in sickle cell patients. However, the muscle function of sickle cell patients has not been investigated and one may suggest that muscle dysfunction could participate in the decrease of physical fitness, in association with the hematological and hemorheological disorders, already reported in this population. The hypothesis is that muscle fatigue during a short localized muscle endurance exercise should be higher in sickle cell patients compared to healthy individuals, due to a greater recruitment of glycolytic fibers and a faster decrease of muscle oxygenation during exercise.


Eligibility Criteria:
Inclusion Criteria:

For Sickle cell patients :

* age ≥ 15 and \< 60 years old,
* SS homozygote or SC heterozygote
* in clinical steady state (i.e. without vaso-occlusive crisis or recent blood transfusion)
* identified by systematic neonatal screening programs,
* registered in the French medical social security national program

For Healthy and non sickle cell subjects:

* age ≥ 18 and \< 60 years old
* without cardiovascular/respiratory/muscle disease,
* registered in the French medical social security national program.

Exclusion Criteria:

* other hemoglobinopathies,
* stroke or vasculopathy history,
* presence of leg ulcers or osteonecrosis,
* recent infectious episode (less than 1 month),
* chronic transfusion therapy programs,
* recent blood transfusion or phlebotomies (less than 3 months),
* patients not at steady state,
* pregnancy or breast feeding
Coproporphyrine Isomers and Methotrexate Elimination

High dose methotrexate (MTX) is responsible of severe toxicity in patients in whom elimination from plasma is delayed. Factors responsible for MTX accumulation are partly known but some patients still experience toxicity despite adequate measures being taken. Our hypothesis is that renal tubular secretion may be impaired in these patients. This study aims at evaluating the performance of the UCP ratio (urinary ratio of coproporphyrins), a putative biomarker of tubular secretion, in predicting delayed MTX elimination.

MTX is a substrate of MRP2, a renal tubular transporter encoded by the ABCC2 gene. It has been shown that single nucleotide polymorphisms (SNPs) on the ABCC2 gene are associated with impairment of MTX elimination. Mutations on the ABCC2 gene are also responsible for the Dubin-Johnson syndrome, characterised by the absence of a functional MRP2 protein. Apart from hyperbilirubinaemia, the main biological perturbation observed in this disease is a typical increase of the urinary ratio of coproporphyrins I (I+ III) (UCP ratio). Our hypothesis is that the UCP ratio could be used as a biomarker of MRP2's activity, thus predicting MTX elimination. One hundred patients treated with high dose MTX will be recruited in this prospective study. Their UCP ratio will be measured before and after MTX administration and correlated with MTX clearance. A genetic analysis will be conducted to study the five more frequents SNPs of ABCC2 in each patient.

Eligibility Criteria:
Inclusion criteria :

* Patients receiving HDMTX (≥1g/m2) for a primitive cerebral lymphoma, a large cell lymphoma, a lymphoblastic lymphoma, a Burkitt's lymphoma or an acute lymphoblastic leukaemia,
* over 18 years old,
* Signed informed consent.
* Affiliated to a medical assurance.
* Able to respect the protocol.
* Effective contraception for women.

Exclusion criteria :

* renal failure,
* liver failure,
* hepatic cytolysis,
* chronic respiratory deficiency,
* pregnancy,
* breast-feeding,
* Concomitant medication: phenytoin, probenecid, trimethoprim, phenylbutazone, salicylates, non steroid anti-inflammatory, yellow fever vaccine.
* Patient included in another study in the four weeks preceding his inclusion.
Serum Calprotectin in Surgical Septic Patients

To early evaluate the serum levels of calprotectin in patients suffering from intra-abdominal sepsis requiring a surgical treatment. The research project aims to investigate the role of serum calprotectin in the diagnosis of sepsis and to establish whether its level significantly correlates with different degree of disease severity and with short and long-term outcomes. If these associations were confirmed, serum calprotectin would represent an easily and rapidly detectable biomarker able to predict the severity of sepsis.

Inclusion criteria are age\>18 years; diagnosis of upper/lower gastro-intestinal perforation, intestinal occlusion, acute cholecystitis, acute appendicitis or intra-abdominal sepsis.

Enrolled patients will be divided in two groups according to the Calgary PIRO (CPIRO) score evaluation: group A includes patients with CPIRO score \</= 2 and represents patient with mild form of intra-abdominal sepsis while group B includes patients with CPIRO score \>/= 3, therefore representing patients with more severe systemic forms. The control group (group C) will be made by elective surgical adult patients.

A blood sample will be collected in sample tubes without anticoagulant from all the eligible patients at admission. After centrifugation, the serum will be stored at -80°C until analysis. The serum level of calprotectin will be measured using a commercially available ELISA Kit based on polyclonal antibodies, according to the manufacturer instruction and fully blinded to any clinical data of the patients or controls.

To our knowledge, this is going to be the first study comparing the levels of serum calprotectin in a large cohort of surgical patients with different degree of intra-abdominal sepsis.

Our primary outcome is to determine whether the serum calprotectin level at the admission is increased in septic patients compared to the control group. We will correlate serum calprotectin level with PCT levels, to check which is the most accurate for the detection of sepsis. Our secondary outcome is to analyze if serum calprotectin level at admission correlates with the clinical severity of sepsis, evaluated trough the CPIRO score. Finally, we will verify if calprotectin level at admission is predictive of short and long-term morbidity and mortality, need for ICU admission and invasive/non-invasive post-operative reinterventions.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of upper/lower gastro-intestinal perforation
* diagnosis of intestinal occlusion
* diagnosis of acute cholecystitis
* diagnosis of complicated acute appendicitis
* radiological diagnosis of intra-abdominal sepsis

Exclusion Criteria:

* recent (\<3 months) surgery
* recent (\<3 months) trauma
* diagnosis of acute pancreatitis
* diagnosis of burn
A Prospective Trial on the Effects of Vitamin D Supplementation in Collegiate Swimmers and Divers

Objective 1: Determine if Vitamin D supplementation can improve body composition, reduce injuries and illnesses, and improve performance in collegiate swimmers and divers.

Objective 2: Examine how baseline Vitamin D levels predict outcome variables over the course of the intervention period.

The investigators plan to recruit from approximately 45 male and female University of Kentucky Swimmers and Divers, at least 18 years of age in August 2011. Approximately equal numbers of men and women will be recruited. The entire athletic team(s) will be recruited. With a conservative dropout rate of 30%, the investigators final sample size should be approximately 22 participants (per group).Following baseline measures, participants will be randomized to one of two groups (Vitamin D 4000 IU or Placebo control) and monitored over the course of their athletic season. Measurements will be repeated at Midpoint (3 months) and Endpoint (6 months).

Participants will have no recent history of Vitamin D supplementation beyond what is normally found in a multivitamin (400 IUs).

Following the informed consent process a medical history and Vitamin D questionnaire (screenings), and urine pregnancy test (for female athletes) will be administered prior to more invasive baseline testing procedures (blood draw and DXA). A blood draw will then be conducted at baseline, midpoint and endpoint. Collected blood for the purposes of this study will assess Vitamin D status (25(OH)D), parathyroid hormone, ionized calcium, bone turnover markers, and inflammatory cytokines. A Vitamin D lifestyle questionnaire will be administered at all 3 time points and incidence of illness and injury will be documented over 6 months following randomization. DXA measures will only occur at Baseline and Endpoint.

Eligibility Criteria:
Inclusion Criteria:

* University of Kentucky Swimmers and Divers, at least 18 years old.
* No recent history of Vitamin D supplementation beyond 400IU

Exclusion Criteria:

* hormone replacement therapy,
* high dose Vitamin D supplementation,
* history of renal disease or kidney stones,
* organ transplantation,
* sarcoidosis,
* parathyroid disease,
* history of high blood calcium levels.
Digital Preop-planning of Total Hip Arthroplasties

Residual leg length discrepancy is a common issue after total hip arthroplasty(THA). Digital preoperative planning may improve the accuracy of the surgical procedure and may help the surgeon to precisely predict implants sizes

Total hip arthroplasties (THAs) are used to restore locomotion. More than 150,000 THAs are performed each year in France. Better outcomes require a restoration of limb lengths and anatomy. Post-operative discrepancy is the main cause of complaints and financial compensation in the US after THA. As such, the investigators aim to use preoperative digital planning using TraumaCad to optimize the restoration of the center of rotation of the hips. Preoperative planning are usually performed using anteroposterior standard radiographs, which are scaled to an inaccurate scale. The TraumaCad system (Brainlab®) allows the adjustment of the scales to each patient and the virtual positioning of the implants in order to simulate the intervention for the restitution of the geometrical parameters of the hip.

Eligibility Criteria:
Inclusion Criteria:

* being older than18 years,
* osteoarthritis as the indication for THA

Exclusion Criteria:

* THAs after femoral neck fractures,
* revision surgery,
* major architectural anomaly (Bone tumor, prior fracture of the pelvis, hip dysplasia),
* patients under legal protection,
* pregnancy or breast-feeding
Efficacy and Safety of Allogenic Stem Cell Product(CARTISTEM®) for Osteochondral Lesion of Talus

The purpose of this study is to evaluate the efficacy and safety of adding CARTISTEM®(allogenic umbilical cord blood-derived stem cell product) on microfracture, a currently standard treatment for OLT, in patients with talar chondral or osteochondral defect.


Eligibility Criteria:
Inclusion Criteria:

1. Talar chondral/osteochondral lesion confirmed by radiographical exam at screening or diagnosis, an AOFAS score of 75 or below
2. Ankle joint pain/stiffness with no response to conservative treatment for more than 12 weeks
3. Ankle joint cartilage injury of defect of ICRS grade Ⅳ in MRI
4. Male or female aged more than 18
5. A one-sided lesion
6. Appropriate function of blood clot: PT(INR) \< 1.5×ULN, aPTT \<1.5×ULN
7. Appropriate renal function: Creatinine ≤ 2.0 ㎎/㎗, Proteinuria ≤ trace
8. Appropriate hepatic function: Total bilirubin ≤ 2.0 ㎎/㎗, AST/ALT ≤ 100 IU/L
9. No evidence of auto-immune disorder: According to investigator's judgement based on relevent symtom and physical exam, anti-nuclear antibody and anti-thyroglobulin antibody tests are able to performed and confirmed negative (If positive, there are possible cases according to diagnostic opinion of medical department)
10. No surgery or radiotherapy for the same ankle joint within 6 weeks
11. Female patients agreeing with maintenance of contraception\* during study period

    \*hormone contraceptive, implants of intrauterine device or intrauterine system, double barrier contraception\[Concurrent use of diaphragm or cervical occlusive cap and male condom\], surgical sterilisation, etc.
12. No chronic ligament instability more than grade Ⅲ (Grade 0: none, Grade Ⅰ: 1\~5㎜, GradeⅡ: 5\~10㎜, Grade Ⅲ: \>10㎜)
13. Patients agreeing with participation in this study and signed on informed consent by their own will

Exclusion Criteria:

1. Degenerative arthritis in ankle(Kellgren Lawrence Grade 3-4)
2. Autoimmune disease
3. Infectious disease need to administration of parenteral antibiotics
4. Myocardial infarction, congestive heart failure, other serious cardiac disorder or uncontrolled resistant hypertension
5. Serious medical disease(Ex. Kidney disease such as chronic renal failure or Glomerulonephritis, etc., acute/chronic liver disease such as liver cirrhosis, fatty liver etc., medical history of malignancy\*)

   \*Complete remission status is possible.
6. Pregnancy or breast-feeding
7. Psychiatric history or epilepsy
8. Alcohol abuse
9. Heavy smoker
10. Chronic inflammatory disease such as rheumatoid arthritis
11. Participants other clinical trials within 4 weeks
12. Administration of immunosuppressing agents such as Cyclosporin A or azathioprine within 6 weeks
13. Patients with acute ligament injury and clinically significant chronic ligament instability
14. Patients treated with surgery or cell therapy product for the same disease
15. Patients with hypersensitivity or allergy history to bovine protein, hyaluronic acid and gentamicin
16. Other inappropriate patients determined by the principal investigator
Molecular Characterization of Spinal Tissue

The researchers are trying to identify molecular mechanisms that control spine deformity and degenerative changes that can be used for therapeutic strategies.

Discarded surgical material from spinal procedures is collected. RNA analysis and other tests on the tissue is performed to determine markers of pathologic disease and to develop pharmacologic treatment strategies for pediatric spinal disorders.

Eligibility Criteria:
Inclusion Criteria:

* Children and adults undergoing surgical procedures where spinal tissues are removed as a normal part of their procedure. Material from adults may be collected as a control group.

Exclusion Criteria:

* Surgeries where spinal tissues are not being removed.