cyrilzakka/clinical-trials huggingface dataset:
The Impact of Biological Mechanisms of Aging on Response Variability to Resistance Training in Older Adults

To critically examine biological, clinical, and behavioral modulators of progressive resistance training-associated exercise response heterogeneity in physical function and whole-body metabolism in older adults.


Eligibility Criteria:
Inclusion Criteria:

* aged greater than or equal to 65 years
* sedentary (Community Healthy Activities Model Program for Seniors physical activity questionnaire to identify and exclude persons engaged in regular (125 min/week or more) moderate intensity physical activity
* at risk for mobility disability score of less than or equal to 10 (but greater than 3) on the SPPB
* willing to be randomized into HE or PRT
* willing to be transported or transport themselves to the clinical sites for the intervention and assessments

Exclusion Criteria:

* unwillingness to provide informed consent
* participation in lifestyle or pharmacologic intervention trial or structured program of exercise training in the past 6 months
* an SPPB score of less than or equal to 3
* osteoarthritis or condition with joint pain limiting daily life activities
* significant weight loss or gain (7.5% of body weight) in past six months
* current anti-coagulant or anti-platelet therapy (Coumadin, Eliquis, Pradaxa, Xarelto, heparin, Lovenox, Plavix)
* clinically significant abnormality in any of the screening laboratory values, including those identified as outside of the "normal limits', that are deemed to be of concern for participation in the study by the study physician
* acute or terminal illness
* Mini Mental State Exam (MMSE) \<23
* myocardial infarction in the previous 6 months or other symptomatic coronary artery disease
* New York Heart Association Class III or IV congestive heart failure
* serious conduction disorder (e.g., 3rd degree heart block), uncontrolled arrhythmia, or new Q waves or ST-segment depressions (\>3 mm) on ECG
* chronic obstructive pulmonary disease requiring oxygen therapy
* upper or lower extremity fracture in the previous 6 months
* uncontrolled hypertension (150/90 mm Hg)
* neuromuscular diseases and/or drugs which affect neuromuscular function
* current use of anabolic steroids, growth hormone, replacement androgen therapy, anti-androgen therapy
* allergy to lidocaine
* presence of significant liver or renal disease (eGFR \< 45 mL/min)
* diagnosis of type I diabetes mellitus or insulin requiring type 2 diabetes mellitus
* HbA1c \> 7%
* BMI \<21 or \>35 for men or \>40 for women
* excessive alcohol intake (\>14 alcoholic beverages per wk.)
* current tobacco use
* current participation in any interventional clinical trial
* current use of weight loss medications
Digital Device Reading Skin Prick Test

Skin prick tests (SPTs), or intraepidermal tests, are the first diagnostic approach for people with a suspected allergy. SPTs are very simple, safe and quick. They are cheap tests and are very useful as a screening test for allergy, especially in diseases like bronchial asthma, rhinoconjunctivitis, food/drug allergy and anaphylaxis. Together with the clinical history, SPTs allow to draw conclusions on allergies based on the sensitization pattern.

Nevertheless, the technique itself has evolved very little and continues to be performed entirely manually. This has a few drawbacks that limit the utility of the tests, in many cases limiting them to a purely qualitative assessment.

In comparison to standard practice (manual measurement), the digital skin test reading device Nexkin DSPT can provide the following benefits for project participants: Automates and digitizes the test reading, provides test results in digital format, reduces variability and subjectivity and greater consistency of diagnosis, reduces manual tasks allowing health professionals providing quantitative instead of qualitative results and avoiding potential human errors and allows a faster workflow, resulting in shorter patient visits.

The aim of this study is to validate the clinical utility of the electromedical skin test reading device Nexkin DSPT regarding its use in allergology clinics for the reading of skin prick allergy tests. The overall purpose of the study is to determine the sensitivity and specificity of skin prick tests (SPT) performed using the current practice of the fully manual SPT procedure and those performed using the Nexkin SPT DSPT (digital) procedure and to compare the sensitivity and specificity of both methods.


Eligibility Criteria:
Inclusion Criteria:

Patients who will undergo skin prick tests with panels of aeroallergens and/or foods.

Over 18 years of age. The patient or their representative has given consent to participate in the study.

The patient must not have taken an antihistamine in the last 5 days.

Exclusion Criteria:

Patients who are evaluated by more than 40 prick tests. Patients who have taken an antihistamine within the previous 5 days. Patients who are being treated with antidepressants or other drugs with an antihistamine effect.

Patients who suffer severe atopic dermatitis with forearm involvement. Patients with dermographism. Patients who are evaluated by intradermal testing. Pregnant women or women suspected to be pregnant. Vulnerable patients
The Efficacy and Safety of DWP16001 in Combination With Metformin in T2DM Patients Inadequately Controlled on Metformin

Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.

A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with T2DM aged 18 to 80 years
2. Subjects who have received metformin alone at a fixed dose for the last 8 weeks and has 7% ≤ HbA1c ≤ 10.5%
3. Subjects with BMI of 20-45 kg/m2
4. Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study

Exclusion Criteria:

1. Subjects with current or history of hypersensitivity to the IP of this study, metformin or drugs of the same class and their components (e.g., history of hypersensitivity to biguanide or SGLT2 inhibitors)
2. Diabetic ketoacidosis, diabetic coma or precoma within the past year
3. Urinary tract infections or genital infections within
4. Uncontrolled hypertension (SBP \> 180 mmHg or DBP \> 110 mmHg)
5. eGFR \< 60 mL/min/1.73 m2
6. Severe heart failure (NYHA class III/IV)
Malawi International Center of Excellence in Malaria Research School-based Cohort

A school-based, prospective, cohort study was conducted to evaluate the epidemiology of P. falciparum (Pf) infections in school-age children and determine the impact of the screen-and-treat approach on Pf infection and anemia prevalence among students in two different transmission settings. Investigators aimed to evaluate how frequently malaria rapid diagnostic tests (mRDTs) fail to detect low-parasite-density infections as well as whether low-density infections contribute to the burden and health consequences of Pf infection in school-age children and whether they contain gametocytes, the parasite stage required for transmission from humans to mosquitos.

Students were enrolled in four schools in southern Malawi in the rainy (March-May) and dry season (Sept-Nov) of 2015. 15 students per grade-level (grades 1-8), were invited to participate. Following enrollment, students were evaluated at baseline for screening-and-treatment, and followed-up 1, 2 and 6 weeks later. At each follow-up visit, a blood sample was obtained for microscopy and molecular detection of parasites and students were interviewed about bed net use the night prior, current or recent illness, and use of antimalarial treatment. At the final visit, a mRDT and hemoglobin test were repeated, and parents were interviewed and portable medical records ("health passports") were reviewed to identify intercurrent fever or malaria treatment.

Eligibility Criteria:
Inclusion Criteria:

* Randomly selected student at a participating school

Exclusion Criteria:

* Parent or guardian not available for consent
* Age \<5 or \>= 16 years
* Known allergy or adverse reaction to lumefantrine-artemether
* Child will not attend this school during the time of the survey
* For the dry season survey (Sept-Oct 2015), participants in the rainy season survey (April-May 2015)
Pathophysiologic Changes in the Respiratory System During Therapeutic Interventions

Airway pressures change during fiberoptic bronchoscopy and endotracheal suctioning. In this study pressure changes are examined in a mechanical lung model and in a population of ICU patients on mechanical ventilation.

Airway pressures change during fiberoptic bronchoscopy and endotracheal suctioning. In this study such pressure changes are examined in a mechanical lung model and in a population of ICU patients on mechanical ventilation. A systematic recording of airway pressures, tidal volumes and blood gases are carried out during ordinary therapeutic procedures requested by the staff physician. No additional study interventions are carried out.

The aim of the project is to examine negative effects of pressure/volume changes.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* on mechanical ventilation
* daily endotracheal suctioning performed

Exclusion Criteria:

* \< 18 years of age
* non-invasive ventilation
Preventive Osteopathic Treatment of Plagiocephaly

Positional cranial deformities (PCD), plagiocephaly and brachycephaly are a common reason for pediatric consultation, which has increased significantly since the recommendation to lay babies on their backs to prevent unexpected infant death (ILD). CPD is a source of concern for parents about their impact on psychomotor development and the aesthetic risk of deformity. The High Authority for Health (HAS) will soon put in place recommendations with a fact sheet for health professionals and the public. The aim of this research is to study whether early treatment of rotation disorders and hypertonia in newborns by manual osteopathic techniques would prevent the occurrence of positional deformities of the skull.

The main objective is to evaluate the effectiveness of an early osteopathic treatment on the rate of CPP (plagiocephalic and postural brachycephalia) at 4 months in newborns at risk.

the secondary objective is: to evaluate the effectiveness of an early osteopathic treatment on the quality of life of the child at 4 months.

Methodology: Controlled, randomized monocentric two-arm parallel study between (1) osteopathic follow-up and (2) osteopathy-free follow-up. The inclusion period will be 18 months and the follow-up period is 4 months.

Procedure: The two groups will be evaluated at 3 days and 4 months. The experimental group will benefit from an osteopathic treatment of 3 days of life to 4 months with a frequency of 3 to 4 sessions. Both groups will benefit from sleeping, carrying, positioning and stimulation advice.

The perspectives are:

* the decrease in the prevalence of CPP after early osteopathic treatment.
* Defining a decision algorithm for early osteopathic treatment.
* Subject to recommendations on the indication of early osteopathic treatment in neonates at risk.


Eligibility Criteria:
Inclusion Criteria:

* Newborn baby aged 3 days and until the maternity leave
* Newborn with at least one risk factor for cranial deformity:

  * Newborn who received instrumental vaginal delivery.
  * Newborn presenting:

    * a preferential side,
    * global axial hypertonia,
    * Localized suboccipital hypertonia
  * Newborn presenting:

    * cranial deformity at birth,
    * a deformation of the face,
    * deformity of the trunk in scoliosis, comma or hyperextension

Exclusion Criteria:

* Newborn with congenital muscular torticollis (managed directly in physiotherapy)

  * Premature neonate (\<37SA)
  * Newborn with a malformation pathology
  * Newborn with craniosynostosis.
  * Newborn with a contraindication to the practice of osteopathy.
Metformin Treatment, Renal Function and Lactic Acidosis

From a central registry at the National Board of Health and Welfare in Sweden collect all patients in the city of Malmö prescribed metformin during two years. Glomerular filtration rate (eGFR) was estimated from the CKD-EPI formula (n=5408) and compared to a control material (n=2815) from the same town. All cases of severe lactic acidosis rendering ICU admission were also sought. The study hypothesis is that metformin is prescribed to patients with lower GFR than anticipated with very few cases of lactic acidosis registered.


Eligibility Criteria:
Inclusion Criteria:

* Patients in the city of Malmö prescribed metformin at least three times during two years
* Available at least one p-creatinine during the two years

Exclusion Criteria:
BAY80-6946 Open Label, Phase I Study in Patients With Advanced Cancer

The purpose of this study is to determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.


Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years.
* Histological or cytological documentation of non-hematologic, malignant solid tumor, excluding primary brain or spinal tumors, or history of central nervous system metastases
* At least one measurable lesion or evaluable disease
* Life expectancy of at least 12 weeks
* ECOG Performance Status of 0, 1 or 2
* PT-INR/PTT \< 1.5 x upper limit of normal \[Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists\]. Low-dose aspirin is permitted (\</= 100 mg daily).
* Adequate bone marrow, liver and renal function
* Ability to understand and to sign an informed consent form; a signed informed consent must be obtained prior to any study specific procedures

Exclusion Criteria:

* History of cardiac disease congestive heart failure (CHF) \> NYHA Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset angina within 3 months prior to study entry or unstable angina or cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or Digoxin are permitted).
* Current diagnosis of type I or II diabetes mellitus or fasting blood glucose level \>125 mg/dL at screening, or HbA1c 7%
* Active clinically serious infections \> Grade 2 (NCI-CTCAE Version 3.0)
* History of having received allogeneic organ transplant
* Uncontrolled seizure disorder. Use of cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital) is not allowed throughout the entire study.
* Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management
Emotional Evaluation and Reconstructed Breast Satisfaction

Data from the National Cancer Institute (Inca) reveal that breast cancer is the most common type of cancer among women worldwide. In Brazil, it is second only to non-melanoma skin cancer. Breast cancer is a feared disease in the female universe because it is considered one of the major causes of death due to neoplasia among women. It brings also the stigma of suffering, mutilation, loss of female identity and loss of body contour. Among other issues, problems with body self-image may have an impact on sexuality and fertility, and also, the incapacity to breastfeed. Breast reconstruction can restore the patient's shape and physical integrity, among other benefits. The research justifies itself because information about the satisfaction of breast reconstruction can be achieved. It is also known that women having breast reconstruction after a mastectomy due to cancer have a favorable evolution. This study will analyze body contour satisfaction of women undergoing mastectomy and breast reconstruction as part of their breast cancer treatment. The Breast Q questionnaire will be used to measure patients satisfaction.

This is a prospective, quasi-experimental study. The subject sample will be composed of women submitted to mastectomy due to breast cancer and to breast reconstruction as part of their treatment. They will be evaluated twice. One when they receive the cancer diagnosis and the other six months after de reconstruction surgery. On both occasions, they will answer the Brest Q questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* women over eighteen years of age;
* women with proven histological diagnosis of breast cancer;
* women who have an indication of mastectomy as part of their treatment;
* women who have breast reconstruction, regardless of the technique used, as part of their treatment;
* women under 70 years of age at the time of the reconstructive surgery

Exclusion Criteria:

* women diagnosed with breast cancer and treated with conservative surgeries;
* women who refuse reconstruction as part of treatment;
* women who refused surgery as part of the treatment for breast cancer
Effect of Arginine Supplementation in the Metabolic Syndrome

The purpose of this study is to determine whether oral supplementation with one form of arginine improves vascular endothelial function in healthy subjects with risk factors associated with the metabolic syndrome

The study is a randomized crossover study including 32 subjects with risk factors associated with metabolic syndrome. In a cross-over design, each subject received oral arginine and placebo, in a randomized order, and were studied the day preceding the first day of administration of arginine (or placebo) and after 4 weeks of arginine (or placebo) supplementation. The two periods of supplementation were separated by a washout period of at least 4 weeks.

The subject were studied in the morning (when before supplementation) and in a whole day (when after supplementation).

The mornings cessions consisted of fasting blood draw and vascular explorations, including a measurement of endothelium-dependent brachial artery reactivity ("Flow mediated dilation"), directly coupled to a measurement of post-ischemic digital reactivity (with the Endo-PAT method), completed by a measurement of non-endothelium-dependent brachial artery reactivity. An analysis of the pulse wave geometry was also performed.

The whole-day cession consisted of the same fasting vascular explorations. Blood tests were performed fasting and repeated 2, 4 and 6 h after ingestion of a high-fat meal (900 kcal). Measurements of Flow mediated dilation was repeated 4h and postischemic digital reactivity were repeated 2, 4 and 6 h after ingestion of the high fat meal.

Eligibility Criteria:
Inclusion Criteria :

* Age between 18 to 60 years old
* Overweight (BMI between 25 and 30 kg/m²)
* 'Hypertriglyceridemic waist' (waist circumference \> 94cm for men or \> 88cm for women and fasting triglyceride levels \> 150 mg/dL)

Exclusion Criteria :

* Obesity (BMI\> 30 kg / m²)
* Cardiac or vascular diseases
* Diabetes
* Thyroid disease
* Systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 90 mmHg
* Tobacco consumption \> 6 cigarettes per week
* Alcohol consumption\> 2 drinks per day
* Any medication (except contraceptive treatment) or dietary supplement intake that could not be arrested more than a week before the first visit for the duration of the study.
* Persons under guardianship
* Positive Hepatitis B virus (HBV), Hepatitis C virus (HCV) and HIV
* Hemoglobin \< 14 g/dl (for men) or \<12 g / dl (for women)
* Participation in a clinical trial within 6 months preceding the study
* Pregnant and lactating women
* For women, menstrual cycle with a duration different from 28 (± 1) days (the cycle is not controlled by a contraceptive treatment at 28 days, or he does not appear spontaneously with regularity)
* Subjects with allergies to final product components
* Contraindications to arginine intake, namely asthmatics subjects, people prone to herpes, patients with liver cirrhosis and renal failure
* Hypotensive patients for whom the use of nitroglycerin is contraindicated.
Genomic-Based Diagnosis, Classification and Targeted Treatment of Multiple Myeloma

Multiple myeloma is an incurable bone marrow cancer characterized by an abnormal expansion of plasma cells that secretes monoclonal immunoglobulin. Over the years, the molecular and genetic heterogeneity of the disease have been dissected. With the maturation of technologies, the time is ripe now to apply genomics to diagnose, classify, risk-stratify and prognosticate myeloma in the clinical setting and use this information to guide current treatment. The investigators hypothesize that the use of gene expression profiling as a single test will be more economical, efficient and accurate compared to the current standard panel of tests done at diagnosis. The investigators also hypothesize that the investigator can use predictive markers to identify prospectively patients who will respond to Velcade and that with more effective trebasedonatment, ability to measure depth of response beyond conventional complete response become important since more patients are achieving conventionally determined complete response. Using a cohort of patients treated on a standard treatment protocol based on Velcade-based induction treatment followed by consolidation and maintenance treatment, the investigators will study specifically the feasibility and accuracy of gene expression diagnostics, the predictive power of the investigators predefined predictive markers and the clinical utility of minimal residual disease measurement in myeloma. The results of the investigators study will allow us to improve the diagnosis, and prognostication of MM patients

1. The investigators hypothesized that this will speed up diagnosis, provide comprehensive information for the classification and risk stratification of MM patients and can completely replace the current FISH assay and may be cheaper.
2. The investigators hypothesized that TRAF3 deletion or mutation and MYC activation will identify patients that will have a significantly better response to Velcade.
3. Modern treatment induced deeper response. More sensitive method of disease detection will allow us to know the fully extent of response to these treatment


Eligibility Criteria:
Inclusion Criteria:

* All Patients fulfilling IMWG diagnostic criteria for myeloma

Exclusion Criteria:

* Unable to take consent
The Feasibility of Propofol TCI in Hemodialysis Patients Undergoing Arteriovenous Shunt Surgery

Written informed consent must be obtained before any study specific procedures are undertaken. Informed consent will be obtained during pre-operative assessment.

The investigators will recruit 80 patients undergoing AV shunt surgery. All patients will receive general anesthesia and brachial plexus block. Patients will be randomly allocated into two groups. Study and control group received propofol target-controlled infusion (TCI) and inhaled anesthetics as anesthesia maintenance, respectively. Main outcomes will be assessed by perioperative blood pressure, heart rate, respiratory rate, end-tidal CO2, analgesics dosage, pain intensity and perioperative adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Uremic adult(over20-year-old)patients under going arteriovenous (AV) shunt surgery

Exclusion Criteria:

* one of below systemic diseases; chronic pulmonary, cardiac diseases(such as COPD, asthma, acute myoischemia), hepatic co-mobility(such as liver cirrhosis), morbid obesity, alcoholism, allergy to propofol and inhaled anesthetics, the women who are pregnant or breastfeeding