cyrilzakka/clinical-trials huggingface dataset:
MitoQ for Fatigue in Multiple Sclerosis

The purpose of this study is to determine whether MS patients who receive Oral mitoquinone (MitoQ) have less fatigue than those receiving a placebo. A comparison between patient's fatigue scored at baseline and fatigue scored 12 weeks after study drug initiation will assess if MitoQ has a significant change in fatigue.

MitoQ is a potent antioxidant with potentially significant immunomodulatory and anti-inflammatory properties. While the cause of MS related fatigue is uncertain, the investigators believe that mitochondria dysfunction and resultant neuronal energy depletion may be an important contributor to fatigue in MS.

This clinical trial will evaluate the potential beneficial effects of MitoQ on MS fatigue. It will also explore the effects of MitoQ on cognitive function, quality of life and mood. If enrolled in the study, patients will take two capsules of the study drug or placebo at the same time every day for twelve weeks. There will be 4 study visits where the participant will undergo medical and nervous system examinations, questionnaires, and blood draws. Because it is a placebo-controlled trial, participants will have a 33% chance of receiving either placebo (inactive), 20mg of MitoQ, or 40mg of MitoQ. This will be a blinded randomized study, meaning neither the participant nor the investigator will know who received the placebo or study drug.

Eligibility Criteria:
Inclusion Criteria:

* MS (any clinical subtype) as diagnosed by the 2010 McDonald criteria40;
* Expanded Disability Status Scale (EDSS) score of 2 to 8,
* Complaint of fatigue that has been persistent for at least two months;
* Modified Fatigue Impact Scale (MFIS) score of 38 or greater

Exclusion Criteria:

* Treatment with systemic glucocorticoids in the prior six weeks;
* Beck Depression Inventory (BDI) \>31 (severe depression);
* Significant MS exacerbation in prior 30 days;
* Previous use of MitoQ or CoQ-10 within 30 days of screening appointment;
* Use of non-research-pharmacy-administered MitoQ or CoQ-10 during the duration of the study;
* Other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus) that might increase risk of patient experiencing adverse events),
* Pregnancy or intending to become pregnant or breastfeeding;
* Unable to complete the self-report forms;
* Unable to give informed consent;
* Prisoners will be excluded.
* Any condition which would make the patient, in the opinion of the investigator, unsuitable for the study.
Pediatric ACL: Understanding Treatment Options

Pediatric ACL: Understanding Treatment Outcomes (PLUTO) is a multi-center, prospective cohort study. Specific aims of PLUTO are to evaluate the safety and comparative effectiveness of non-operative treatment, as well as four operative treatments including (1) transphyseal ACL reconstruction (2) partial transphyseal ACL reconstruction, (3) physeal-sparing epiphyseal ACL reconstruction using the Anderson technique, and (4) physeal-sparing ACL reconstruction using the Micheli/Kocher technique in prepubescent and pubescent skeletally immature patients.

Anterior Cruciate Ligament (ACL) injuries are being seen with increased frequency in pediatric and adolescent patients. The management of these injuries is controversial and includes nonoperative treatment and operative treatment with various surgical techniques. Pediatric ACL: Understanding Treatment Outcomes (PLUTO) is a multi-center, prospective cohort study. Specific aims of PLUTO are to evaluate the safety and comparative effectiveness of non-operative treatment, as well as four operative treatments including (1) transphyseal ACL reconstruction (2) partial transphyseal ACL reconstruction, (3) physeal-sparing epiphyseal ACL reconstruction using the Anderson technique, and (4) physeal-sparing ACL reconstruction using the Micheli/Kocher technique in prepubescent and pubescent skeletally immature patients. Accrual will take place over eight years at 9 pediatric sports medicine centers. Post-treatment outcome assessment will be performed at 6-9 months, 1 year, and 2, 5, and 10 years after treatment , including functional outcome, activity level, health-related quality of life, graft survivorship, knee stability, knee motion, and growth disturbance.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of complete intrasubstance ACL tear
* Skeletally Immature (by knee radiographs)

Exclusion Criteria:

* Prior ACL surgery on the ipsilateral knee
* Congenital ACL deficiency
* Multiple ligament reconstruction required
* Other significant comorbidities including syndromic conditions, neuromuscular disorders or developmental delay
* If scheduling of the ACL surgery is impacted by the skeletal maturity of the patient
* Simultaneous bilateral ACL tears
Technological Processes on Quality of Meat

This project aims to assess the impact of technological processes of meat, as cooking conditions, on amino acid bioavailability and protein metabolism. The hypothesis is that, even if meat is considered as a good provider of fast proteins and so could be useful to prevent sarcopenia in aged people, the manner it is cooked can change its digestion rate and amino acids bioavailability for muscle synthesis.

Beef meat, whose proteins were intrinsically labelled with 15 N, was previously obtained by infusing 15N ammonium sulphate during 50 days in the rumen of an heifer. Two different cooking conditions have been applied to this meat (5 min at 55°C vs 30 min at 90°C). Ten healthy elderly volunteers will test each processed meat according to a cross-over design, during 2 different metabolic studies separated by at least 2 weeks. Volunteers will be submitted to a diet controlled for its protein content, for 4 days (1.2 g protein/kg/day) before each metabolic investigation.

On the 2 days of metabolic investigations, after an overnight fast, blood samples will be collected for basal measurements. Then the subjects will be perfused with L-\[1-13C\] leucine for 9h30 hours, during which expired gas and blood samples will be regularly taken, and CO2 production measured. The volunteers will be asked to eat a 130 g beef meat 2.5h after the onset of the perfusion. Isotopic enrichments in expired gas, in plasma alpha-cetoiscaproate and in free leucine will be measured to determine whole body amino acids fluxes (oxidation, protein synthesis and proteolysis). 15N enrichments of leucine will allow splanchnic extraction measurement.

Eligibility Criteria:
Inclusion Criteria :

* Male
* Age \> 70
* Body mass index 21 \< BMI \< 28 kg/m2
* Affiliated to National Health Insurance
* Subject giving his written informed consent
* Subject considered as normal after clinical and medical examinations

Exclusion Criteria :

* Positive serologies to HIV or HCV, or abnormal laboratory tests
* Previous medical and/or surgery judged by the investigator as incompatible with this study
* Person who doesn't eat beef or only if prepared according to religious rite
* Person wearing a removable denture or suffering of dry mouth syndrome
* Regular medication with glucocorticoids
* Intense sports activity \> 7h/week
* Heavy alcohol consumption
* Being under someone's supervision
* Refusal to be registered on the National Volunteers Data file
* Being in exclusion on the National Volunteers Data file
Effects of Adalat LA and Coracten on Drug Levels, Blood Pressure, and Heart Rate in Fed Patients With Hypertension

This study compares the effect of Adalat LA to Coracten on drug levels as well as changes in blood pressure and heart rate in fed hypertensive subjects. Subjects are dosed with either Adalat or Coracten for first 2 weeks, followed by the other drug for 2 weeks, and then switched back to the original drug for one day. Blood samples, blood pressure, and heart rate are taken before and after each treatment period.


Eligibility Criteria:
Inclusion Criteria:- Mild to moderate hypertension (sitting DBP \> 95 - \<114 mmHg and/or SBP \> 140 - \< 160 mmHg) currently untreated. or- Previously diagnosed mild to moderate hypertension (DBP 95-114 mmHg and/or SBP 140 - 160 mmHg) well controlled on current treatment but experiencing adverse events who can be safely switched to the study treatments. or- Previously diagnosed mild to moderate hypertension (DBP 95-114 mmHg and/or SBP 140 - 160 mmHg), well controlled on current treatment, without adverse events, and willing to participate in the study. Exclusion Criteria:- Females who are pregnant, nursing or of childbearing age, unless sterilised. Subjects receiving any form of contraception are not eligible.- Subjects with a medical history of cardiac disease within 6 months (e.g. myocarditis or pericarditis, aortic stenosis, myocardial infarction, unstable angina pectoris or severe angina pectoris). - Subjects with history or evidence of congestive heart failure- Subjects with evidence of clinically important arrhythmia or conduction disturbances requiring treatment.- Subjects with severe liver disease (liver enzymes twice the upper limit of "normal") or other gastrointestinal (GI) tract diseases including inflammatory bowel disease or Crohns disease- Subjects with lactose intolerance.- Subjects with renal diseases (creatinine \> 1.5 mg/dL), which could alter the absorption, metabolism or excretion of the study drugs.- Subjects with Type I diabetes. - Subjects taking drugs which may interfere with the metabolism of nifedipine (cimetidine, ranitidine, quinidine, digoxin, rifampicin, diltiazem, cisapride, quinupristin/dalfopristin, cyclosporin, phenytoin or other antiepileptic drugs,).- Subjects suffering from secondary or malignant hypertension.- Subjects with any known contraindication (e.g. hypersensitivity) to nifedipine or other calcium channel blockers of the dihydropyridine class.- Subjects with previously known clinically significant abnormalities of laboratory tests that might suggest further investigation.- Subjects with a resting heart rate \< 50 bpm or \> 100 bpm.- Subjects with a history of drug and/or alcohol abuse.- Subjects unwilling to comply with the protocol.- Subjects who have participated in another clinical trial within the last month.- Subjects with neurologic or psychiatric illness requiring medication (e.g. tricyclic antidepressants, MAO inhibitors).- Subjects with clinical evidence of ongoing or recent (within the last year) stroke or transient ischemic attacks.- Subjects with pre-existing severe gastrointestinal or oesophageal constriction or narrowing.
Phase Ib Study of Olaparib Plus Weekly Carboplatin and Paclitaxel in Relapsed Ovarian Cancer

The purpose of this study is to determine the maximum tolerated dose (MTD) of the investigational agent, olaparib, to give in combination with carboplatin and paclitaxel in patients with relapsed ovarian cancer or uterine cancer. Furthermore, the investigators intend to study the safety and tolerability of the study treatment, response to treatment, time to disease progression, and overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Advanced (stage III or IV), histologically or cytologically documented ovarian cancer or serious uterine cancer patients who relapsed after primary therapy with a platinum and a taxane. This includes:

  * Platinum sensitive: relapsed at least 6 months following platinum treatment
  * Platinum refractory: the cancer grew while on platinum treatment
  * Platinum resistant: recurrence within 6 months of platinum treatment
* Must have failed first line treatment
* ECOG performance status 0-2
* Must be able to swallow and retain oral medication
* Life expectancy greater than 16 weeks
* Must have normal organ and bone marrow function defined as follows:

  * Hemoglobin ≥ 9.0 g/dL
  * Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
  * White blood cells (WBC) \> 3 x 10\^9/L
  * Platelet count ≥ 100 10\^9/L
  * Total bilirubin ≤ 1.5 x institutional upper limit of normal
  * AST (SGOT)/ALT (SGPT) ≤ x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5 ULN
  * Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN)

Exclusion Criteria:

* Any previous treatment with a PARP inhibitor, including olaparib
* Any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or longer period depending on the defined characteristics of the agents used)
* Currently receiving the following classes of inhibitors of CYP3A4: azole antifungals, macrolide antibiotics, and protease inhibitors
* Second primary cancer except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years
* Symptomatic uncontrolled brain metastases
* Major surgery within 2 weeks of starting study treatment
* Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV)
* Known active hepatic disease (i.e. Hepatitis B or C)
* Uncontrolled seizures
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin or paclitaxel
Expectations, Satisfaction and Quality of Life in Total Hip Arthroplasty

The goals of this study are to identify predictors of improvement in quality of life and satisfaction with total hip arthroplasty three to five years after surgery.

The goals of this study are to identify predictors of improvement in quality of life and satisfaction with total hip arthroplasty three to five years after surgery. Predictors that will be considered are variables that were obtained prospectively and systematically at the time of surgery, including demographic characteristics, functional status, expectations, perioperative complications, and comorbidity. At the follow-up functional status and patient satisfaction will be measured, as well as fulfillment of expectations and predispositional factors.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be eligible for this study if they are part of an assembled cohort of patients who underwent primary unilateral or bilateral total hip arthroplasty in 1998-2000 at the Hospital for Special Surgery.

Exclusion Criteria:

* Patients will be excluded if they are unable to be interviewed, refuse to participate, or are deceased.
Safety and Pharmacokinetis of TAP311 in Dyslipidemic Patients

The study will assess the safety, tolerability and pharmacokinetics of TAP311 in patients with dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 18 to 80 years (inclusive) of age.
* Patients are not treated for dyslipidemia with medications other than HMG-CoA reductase inhibitors (statins) for at least 4 weeks prior to Day 1. Patients should be on stable doses of current medications, if any, for at least 3 months to be eligible.
* Patients must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 40 kg/m2.

Exclusion Criteria:

* Use of other investigational drugs at the time of enrollment
* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
* Use of lipid modifying agents (e.g. fenofibrate, niacin, omega-3 fatty acids, etc.) other than statins will exclude subjects.
* Pregnant or nursing (lactating) women
* Diabetic patients whose plasma glucose is not well controlled by stable diabetic treatment for at least 3 months
* Heavy smokers (smoke more than 10 cigarettes a day routinely and who cannot refrain from smoking during the study).
* Women of child-bearing potential (WOCBP) can be included but must use highly effective contraception
* Significant illness within two (2) weeks prior to initial dosing
* History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
Solar Lentigines Treatment With the Triple Combination Cream

Background

* Lentigines are usually the first sign of photoaging and may produce a significant impact on patients' quality of life.
* There is no a treatment of choice for this condition.
* Solar lentigines and melasma share similar physiopathologic characteristics.
* The triple combination (TC) cream (hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01%) has been effective and safe for the treatment of melasma and other hyperpigmented lesions.

Hypothesis

\* The TC cream will be effective and safe for the treatment of solar lentigines on the back of the hands.

Patients and methods

* 22 patients with solar lentigines were selected and their right hand or left hand were selected at random to be treated with either TC cream or tretinoin 0.05% cream once daily for up 12 weeks.
* Patients were instructed to apply both creams on the whole back of the hand and not only in the lentigines, and to use a broad-spectrum sunscreen (SPF 50+, UVA-PF 28) daily in both hands.
* Clinical assessments of Target Lesion Pigmentation, Physician's Global Assessment of Improvement and a Subject's Self-Assessment questionnaire were collected for data analysis at weeks 4, 8, and 12 after starting the treatment and 3 month post-treatment.
* Statistical methods: The ordinally scaled efficacy measures underwent rank transformation and were analyzed by analysis of variance to test the null hypothesis of no differences among treatments. We performed Mann-Whitney and Wilcoxon tests and the XLSTAT 2009 software was used.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of both sexes of 30 - 80 years of age.
* Phototype II-V.
* Postmenopausal women of childbearing age or users of any contraception method with negative pregnancy test (beta subunit chorionic gonadotropin in the blood) at baseline and that maintain the contraceptive treatment during the investigation.
* Subjects with more than 10 solar lentigines on the back of each hand wich were no treated in the last 6 months

Exclusion Criteria:

* Patients under 30 or over 80 years of age.
* Skin types I and VI.
* Less than 10 solar lentigines on the back of each hand.
* Patients who have received or are receiving any other treatment for lentigines of the back of hands.
* Women of childbearing age without contraceptive therapy.
* Pregnancy or lactation.
* History of hypersensitivity to any component of the drugs.
* Simultaneous use of other topical skin lightening.
* Patient refusal to participate in the study.
The Use of Cannabidiol in Cancer Patients

Alternative and complementary medicines (MAC) are commonly used by cancer patients to help them to face with anticancer treatment, reduce oncology symptoms and/or anticancer treatment adverse effects, detoxifying the body. In consistence with guidelines from the French Society for Oncology Pharmacy (SFPO), the pharmaceutical consultation includes a discussion and collection of herbs, botanical and other natural products consumed by cancer patients. This aim to prevent and manage herb-drug interaction as well as other drug-related problems (DRP). The recent French experimentation dedicated to cannabidiol for medical use could enhance interest of cancer patients in the field of MAC. However, cannabidiol have shown inhibitory effect on different cytochromes with a risk of HDI as other MAC. While the prevalence of MAC consumption is already known in some type of cancer, the consumption of CBD is less known and should be explored. Through this study we wish to know the prevalence of cannabidiol consumption in cancer patients and to establish a typical profile as well as to know the modalities of use. We also want to validate a questionnaire through a literacy scale.

* A Prospective observational study
* Conducted in an oncology day-hospital (CHU de Reims)

All data collected were:

* Clinical characteristics,
* Administrative data,
* Medication review,
* Biologic data collection,
* Oncological data,
* Disease data

Statistical analysis:

* Quantitative variables: described as mean ± standard deviation (SD) or median (Interquartile range and minimum and maximum)
* Student test and Fischer exact performed to compare CBD users and non-users.
* Analysis of variance: used to compare scores between different variables
* Univariate logistic and multivariate logistic regressions were performed. Variables with a p-value \< 0.20 (Wald test) in the univariable analyses were considered eligible for the multivariable models.

Eligibility Criteria:
inclusion criteria: All the patients (\>18yo) who received anticancer treatment

exclusion criteria:

* Patients who received anticancer drug with very short administration time (typically subcutaneous anticancer drugs as 5-azacitidine, bortezomib and some monoclonal antibodies)
* Patients who were not able to speak and understand French as well as who were unable to communicate clearly.
Impact of Adult Asthma

To assess the separate and interactive effects of asthma severity, subspecialty practice variation, asthma-related psychosocial variables, and other factors on asthma outcomes, including asthma-specific quality of life and activity limitations, health care utilization for asthma, and direct and indirect costs of asthma.

BACKGROUND:

Asthma is both common and costly. Neither the risk factors of poor outcome nor the predictors of better outcome are well understood. Illness severity is clearly an important predictive factor in asthma, but may explain less variability in outcome than other determinants, such as patient-perceived asthma control, other asthma-related psychosocial measures, and the kind and extent of subspecialty care for asthma. By quantifying predictors of asthma-specific quality of life, functional status, services utilization, and the direct and indirect illness costs of asthma, this study addressed a major research gap in secondary and tertiary prevention efforts.

DESIGN NARRATIVE:

A random sample of pulmonary and allergy subspecialists initially enrolled 600 persons with asthma identified in patient visit logs. This established panel completed 45 minute baseline and follow-up computer-assisted telephone interviews (CATI); 539 (90%) were successfully re-interviewed after 18 months of follow-up. A supplemental sampling frame of persons with asthma identified from family practitioners was completed as was a group with rhinitis but without asthma. Interviews assessed disease severity and other covariables using validated survey instruments. Pulmonary function and medical records were used to validate severity in a sub-sample of subjects. The study extended longitudinal follow-up study of this initial cohort. Its analysis tested predictive models for the asthma outcomes of interest.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria