cyrilzakka/clinical-trials huggingface dataset:
Effect of the High Impact Exercise on Bone Density in Prepuberal Girls

Osteoporosis has become a worldwide concern an a matter of public health as osteoporosis is a major contributing factor associated with insufficiency fracture of the spine, wrist and proximal femur, and as a result, can diminish quality of life as well as increase direct and indirect healthcare costs.

The pathophysiology of osteoporosis is based on two main factors; low bone mass and age associated architectural changes within the bone, high impact exercise in childhood can improve the peak bone mass and bone architecture. The evidence suggests that bone adaptation to increased load is optimal in early puberty (Tanner stages I and II) since around 30% of total body adult bone mass is accrued during this period.

However, the optimal exercise program for increasing peak bone mineral content is still unclear. Therefore, the aim of this study is to assess if 15 minutes of high-impact exercise three times per week improve areal bone mineral density assessed by DXA of pre pubertal girls after a ten-month regimen compared to low-impact exercise. This information could highly impact the development of public health policies directed to pre pubertal girls.


Eligibility Criteria:
Inclusion Criteria:

* Girls between ages 8 to 10
* Tanner I

Exclusion Criteria:

* Precocious menarche (within the selected timeframe)
* Chronic disorders or medications known to affect bone metabolism or musculoskeletal function.
* Body Mass Index 30 or higher
* Regular vigorous physical activity (training more than 8 hours per week)
Effects Of Ingesting An Energy Bar On Performance And Recovery

The purpose of this study is to determine the effects of ingesting a low glycemic whey protein energy bar prior, during and following resistance exercise and conditioning on performance and recovery.

Fit-joy is a commercially available food bar marketed as having a low glycemic index and being relatively high in dietary fiber. The fiber contained within this product is isomalto-oligosaccharides (IMO) which is a food ingredient with a relative sweetness level equal to approximately 60% of sucrose. Chemically, IMO is a mixture of glucose oligomers with alpha - (1-6) - linkages. Short and hard exercise produces muscle damage and soreness. The Fit-joy bar contains whey protein that previous research in the investigator's lab showed may be able to decrease the muscle damaging effects of exercise while also helping with muscle growth. The purpose of this study will be to determine if eating a Fit-joy bar before and in the middle of a hard weight training workout will promote positive results during the workout and 48 hours after the workout.

Eligibility Criteria:
Inclusion Criteria:

* Participant is between the ages of 18 and 35
* Participant is apparently healthy
* Participant is involved in a a consistent strength and conditioning program consisting of upper and lower body resistance exercises as well as cardiovascular or sprint conditioning training (for at least the past year for 2-4 days/week), bench press at least your body weight and squat at least 1.5 times your body weight and/or leg press twice your body weight.
* Participant has a Body Mass Index (BMI) \< 24.9 or Body Fat Percentage (%BF) \< 25.0

Exclusion Criteria:

* Participant has a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypo-tension, thyroid disease, arrhythmia, cardiovascular disease
* Participant has a food allergy (i.e., milk, soy, egg, wheat or nuts)
* Participant uses current prescription medication (birth control is allowed)
* Participant is pregnant or nursing or plans to become pregnant during the next month
* Participant has an intolerance to caffeine and/or other natural stimulants
* Participant has a history of smoking
* Participant drinks excessively (i.e., 12 drinks per week or more)
A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Early Asymptomatic HIV Infection

To assess the magnitude and duration of the antiviral activity in plasma and the incidence and time to total suppression of detectable HIV RNA in plasma. To assess the long-term safety and tolerability of this combination therapy and the magnitude and duration of the effect of this therapy over CD4 cell counts.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Documented HIV infection.
* CD4 count \> 500 cells/mm3.
* No HIV-associated symptoms.
* Written, informed consent from parent or legal guardian for patients \< 18 years old.
* Availability for follow-up for at least 96 weeks.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions and symptoms are excluded:

* Presence of a newly diagnosed AIDS-defining opportunistic infection requiring acute therapy at the time of enrollment.
* Intractable diarrhea.
* Signs and symptoms of bilateral peripheral neuropathy \>= Grade 2.
* Inability to tolerate oral medication.
* Hemophilia, other bleeding disorder, or no accessible tonsillar or lymph node tissue.

Patients with the following prior conditions are excluded:

History of acute or chronic pancreatitis. 1. Use of potent neurotoxic drugs is not permitted.

* No other anti-HIV therapy allowed.
* Nelfinavir should not be administered concurrently with rifampin or rifabutin, terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion), and midazolam (Versed).

  1. Any prior antiretroviral therapy.
* Prior vaccination with a candidate HIV therapeutic vaccine.
* Previous therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or the expected need for such therapy at the time of enrollment.
* Previous therapy with rifampin or rifabutin, terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion), and midazolam (Versed) within 14 days prior to study entry or at any time while on study.

Active alcohol or substance abuse.
Outcomes of a New Trans-epithelial Photorefractive Keratectomy (Streamlight PRK) Compared to Conventional PRK Procedures

Photorefractive keratectomy (PRK) involves mechanical or alcohol assisted debridement of the epithelium that leads to potential basement membrane (BM) injury ,with resultant more significant haze and pain compared to laser assisted epithelial removal known as 2 step trans-epithelial PRK (PTK-PRK). Our study is focusing on comparing the outcomes of the conventional 2 step trans-epithelial PTK-PRK to the new single step trans-epithelial PRK (StreamLight PRK, Alcon lab, TX, USA).

Photorefractive keratectomy (PRK) is nowadays one of the commonest refractive procedures in laser vision correction (LVC). PRK differs from laser in situ keratomileusis (LASIK) in that it's a flapless procedure involving the removal of corneal epithelium with different techniques including manual removal , alcohol assisted removal or excimer laser assisted removal with phototherapeutic keratectomy (PTK). Mechanical or alcohol assisted debridement of the epithelium may lead to potential basement membrane (BM) injury ,with resultant more significant haze and pain compared to laser assisted epithelial removal known as 2 step trans-epithelial PRK (PTK-PRK).

Single step trans-epithelial PRK allows removing the epithelium and stroma in a single step with a single ablation profile.

Previous studies paid particular attention for comparing the 2 step PTK-PRK procedure or the new single step PRK procedure to the conventional PRK procedures involving epithelial removal whether manual or alcohol assisted.

The aim of this study is to focus on comparing the different outcomes of the new single step Trans-epithelial PRK (StreamLight Technology) versus the routine 2 step PTK-PRK in terms of postoperative vision, epithelial healing, pain scoring and haze evaluation.

Eligibility Criteria:
* Inclusion Criteria: Candidates for Laser vision correction (LVC) with

  1. Myopia up to -6 diopters
  2. Myopic astigmatism up to -4 diopters
  3. Corneal thinnest location ≥ 500 um and a residual stromal bed ≥ 300um.
* Exclusion criteria

  1. Patients not candidates for LVC.
  2. Hyperopic patients.
  3. Systemic disease that contraindicates LVC.
  4. Intra- or post-operative complications.
"Principle Test" for Isolation and Characterization of Circulating Cancer Cells (CTC)-CXCR4+.

This is multicentric, interventional, non farmacological and prospective study.

The new CLG platform, a prototype owned by IRCCS Pascale Institute, is able to reconstruct a PMN for the capture of CTCs able to extravasare and colonize tissues at distance, a fundamental requirement to begin the process of metastasis formation. The purpose of the study is to evaluate in vitro the effectiveness of CLG in the isolation, recovery and subsequent molecular characterization of CTCs from peripheral blood of patients suffering from solid neoplasms (endometrium, kidney, colorectal, glioblastoma and lung).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* Signature of Informed Consent
* Advanced solid neoplasm with metastases

Exclusion Criteria:

* Age \<18
* Refusal to sign informed consent
An Investigation of Light Therapy for Cancer-related Fatigue (The LITE Study)

Cancer-related fatigue is one of the most common and distressing symptoms associated with a cancer diagnosis.Fatigue related to cancer often appears before a diagnosis, worsens during treatment, and lasts for years after treatment in up to 35% of patients. Despite the long-term effects of cancer-related fatigue, the treatment options available are not always appropriate or helpful for all patients.Light therapy is an effective treatment for other disorders related to fatigue. The purpose of the study is to investigate the role of light therapy on quality of life, sleep patterns, and physical measures of immune function and stress hormones in individuals with post-treatment cancer-related fatigue.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Non metastatic cancer
* At least 3 months post chemotherapy/radiation treatment (hormone treatment ok)
* Meets criteria for cancer-related fatigue

Exclusion Criteria:

* Under 18 years of age
* Presence of a sleep disorder other than insomnia or hypersomnia
* Shift work
* Presence of an Axis-I psychiatric condition
* Presence of a medical condition that may impact levels of fatigue
* Presence of conditions contraindicated to the use of light therapy or photosensitizing medications
* Randomization refusal
The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy

This study will determine how the intestinal microbiome differs between patients with obesity and early triple-negative breast cancer who achieve a pathologic complete response from preoperative anti-PD-1 immunotherapy (pembrolizumab) versus patients who do not.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Female biological sex
* Newly diagnosed, previously untreated, histologically confirmed early triple-negative breast cancer
* Plan to initiate preoperative anti-PD-1 immunotherapy using pembrolizumab
* Overweight or obesity, defined as a body mass index \>=25 kg/m2
* Ability to provide written informed consent
* Allow the collection and storage of biospecimens and data for future use

Exclusion Criteria:

* Active autoimmune disease
* Concomitant conditions that require the use of antibiotics (e.g., chronic sinusitis)
* Digestive disease disorders (e.g., irritable bowel syndrome, Crohn's disease)
* Currently pregnant, breastfeeding, or planning to become pregnant within the next 24 weeks
* Recent (within 90 days) use of glucocorticoids for more than 10 consecutive days
* Any other cardiovascular, pulmonary, orthopedic, neurologic, psychiatric, or other condition that, in the investigator's opinion, would preclude participation or successful compliance with the protocol
* Any other situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol
Pediatric Intubation by Nurses

The purpose of this study was to compare the Pentax AWS, Intubrite and AirTraq to Miller laryngoscope during pediatric resuscitation with and without chest compressions.

Endotracheal intubation (ETI) is a life-saving procedure performed daily in emergency medicine. The European Resuscitation Council (ERC) 2010 cardiopulmonary resuscitation (CPR) guidelines suggest that intubators should be able to secure the airway without interrupting chest compression. However, ETI with uninterrupted chest compression in patients can be a very difficult skill to acquire.

Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* minimum 1 year of work experience in emergency medicine
* experienced emergency medical personnel - nurses

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
Two Strategies of RDS Treatment in Newborns With Birth Weight > 1500 Grams

The purpose of this study is to compare two different treatment strategies for RDS in preterm infants \> 1500 grams and evaluate whether a selective surfactant administration would reduce the need of intubation, mechanical ventilation and surfactant use.

Respiratory Distress Syndrome (RDS) is a frequent respiratory problem of preterm infants and an important cause of morbidity and mortality.

The management of this disease usually includes intubation, surfactant administration and mechanical ventilation in infants less than 1500 grams. However, in patients over this weight, the treatment has not been standardized and depends on the clinical progression of oxygen requirements.

Hypothesis:

- Early CPAP and selective surfactant administration is an effective treatment for RDS in infants \>1500 g. This could decrease or avoid intubation and surfactant administration.

Comparison(s):

Early surfactant administration, when the FiO2 ≥ 0.4. compared to selective surfactant administration when the arterial to alveolar oxygen tension ratio (a/APO2) is ≤ 0.21.

Eligibility Criteria:
Inclusion Criteria:

* Birth Weight \> 1500 g.
* First day of life.
* Clinical and radiological signs of RDS.
* Oxygen requirement over 30% to reach an oxygen saturation of 88%.
* Parent's consent approved.

Exclusion Criteria:

* Neonatal asphyxia, 5 minute Apgar \< 3 or cord pH \<7.0.
* Cardiac or respiratory malformation.
* Chromosomal disease.
* Significative pneumothorax.
Function of High Density Lipoproteins in Acute Coronary Syndromes

High density lipoproteins (HDL) have many effects that protect against cardiovascular diseases. In an acute heart attack (acute coronary syndrome -ACS), HDL change in composition and structure, reflecting the inflammatory environment that accompanies an ACS. The investigators will examine the function of HDL during an ACS and again when the patient has recovered.

High density lipoproteins (HDL) have pleiotropic effects associated with protection against atherosclerosis. These effects include cellular cholesterol efflux, anti-inflammatory and anti-oxidant effects, increase in nitric acid (NO) production from vascular endothelial cells and differentiation of endothelial progenitor cells for repair at sites of vascular injury. The measurement of the cholesterol mass within HDL (HDL-C) does not provide an adequate measure of HDL function. The investigators therefore propose to test and validate biomarkers of HDL function in patients with acute coronary syndromes (ACS).

Hypothesis: HDL lose their cardiovascular protective functions in ACS. The investigators hypothesize that these changes are transient and partly normalize within 12 weeks. In this proposal, the investigators will examine the function of HDL in acute coronary syndromes (ACS) and 12 weeks later, in the recovery phase. Acute coronary syndromes are characterized by an acute inflammatory reaction, a marked decrease in HDL in plasma and a shift of the HDL proteome to an inflammatory phenotype.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 18-80 years of age
* Acute Coronary Syndrome within 72 hours of presentation
* Elevated tropinins (T or I)

Exclusion Criteria:

* Refusal to participate
* Inability to return for a 12 week follow-up visit
* Hemodynamic instability requiring vasopressor support, mechanical ventricular assist devices, the need for coronary artery bypass surgery
* Lack of documented atherosclerotic CAD
* Uncontrolled hypertension
* Triglycerides≥5mmol/L
* Severe obesity (BMI≥35)
* Alcohol intake\>21 drinks/week
* Presence of thyroid, hepatic, or renal disease
* Autoimmune disease or any chronic or acute infectious or inflammatory illness
The Evaluation of Immunogenicity and Safety of NBP608 in Healthy Children 12 Months to 12 Years of Age

This study evaluates the immunogenicity and safety of three different potencies of NBP608 and Varivax which are indicated for active immunization for the prevention of varicella. Total of 152 subjects (38 subjects per each treatment arm) of 12 months to 12 years of age are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned.

This is a multi-center, randomized, double blinded, active controlled, parallel-group study to evaluate the immunogenicity and safety of three different potencies of NBP608(low, middle, high potency) and Varivax which are indicated for active immunization for the prevention of varicella. Total of 152 subjects (38 subjects per each treatment arm) of 12 months to 12 years of age are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned in 1:1:1:1 ratio. Stratified randomization for age group is used to achieve the balance of treatment assignment within age strata.

Total of four visits are scheduled including two visits via telephone contact. Blood sampling is conducted for immunogenicity assessment before and 6 weeks after vaccination at Visit 1 and Visit 3 respectively. Safety is monitored 1 week, 6 weeks and 26 weeks after vaccination through Visit 2\*, Visit 3 and Visit 4\* (\*telephone contact)

Eligibility Criteria:
Inclusion Criteria:

* Healthy children aged between 12 months and 12 years old who are available for the follow-up during the study period
* After menarche females who are confirmed to be negative in a pregnancy test on the day of vaccination and agree to practice birth control for 3 months after the vaccination

Exclusion Criteria:

* Those with hypersensitivity to any component of the IPs(Investigational Products), such as gelatin or neomycin
* Those who have received a varicella vaccine previously
* Those with a history of hypersensitivity to vaccination, such as Guillain-Barre syndrome
* Those with congenital or acquired immunodeficiency
* Those with active untreated tuberculosis
* Those who have received or are expected to receive salicylates from 14 days prior to IP(Investigational Product) vaccination to Visit 3
* Those who have received or are expected to receive other vaccines from 1 month prior to IP(Investigational Product) to Visit 3
* Those who have received or are expected to receive other IPs(Investigational Products) in another clinical study from 1 month prior to IP(Investigational Product) vaccination to Visit 3
Anti-Migration System for Anti-reflux Oeso-gastric Stent (ANTIMIG)

The aim of this prospective, controlled, randomized, multicentre, single-blind study is to compare the rate of intragastric migration of 2 types of esophageal stents with and without an anti-migration device placed for locally advanced or metastatic malignant stenosis of the gastroesophageal junction.

In order to reduce the rate of spontaneous intragastric migration of esophageal stent placed for gastroesophageal junction tumor, anti-migration device has been developed. Pilot studies suggest the absence of morbidity of this device, but no comparative study has been conducted to confirm the interest of this anti-migration device.

The aim of this study is to compare the rate of intragastric migration of 2 types of esophageal stents with and without an anti-migration device placed for locally advanced or metastatic malignant stenosis of the gastroesophageal junction.

* Main objective: To evaluate the rate of intragastric migration of 2 types of esophageal stents (one with and the second without anti-migration device) placed for malignant stenosis of the gastroesophageal junction.
* Secondary objective(s):

  * Degraded migration rate (M3 and M6) if patient alive, and duration of survival without dysphagia
  * Comparison of the morbidity of these two stents
  * Comparison of the effectiveness of these two stents on dysphagia and reflux
  * Clinical and technical failure rate of these two stents

This is a prospective, controlled, randomized, multicentre, single-blind study.

Eligibility Criteria:
Inclusion Criteria:

1. Patient of both sexes aged 18 or over.
2. Patient admitted to one of the investigation centers for dysphagia due to tumoral stenosis of the gastroesophageal junction, locally advanced or metastatic.
3. Patient ASA 1, ASA 2, ASA 3
4. Absence of participation in another clinical study
5. Signed Informed Consent
6. Patients benefiting from the social security system.

Exclusion Criteria:

1. Patient referred for stenosis by extrinsic compression by an extra digestive mass
2. Patients with contraindications relating to the procedures essential for the introduction of a stent
3. Mediastinal radiotherapy or esophageal surgery history
4. Patient under 18 or over 90
5. Patient ASA 4, ASA 5
6. Pregnant Woman
7. Patient unable to give personal consent
8. Absence of signed informed consent
The Effects of Atorvastatin on the Nitric Oxide-system in Patients With Non-diabetic Nephropathy

It has been documented that statin reduce mortality and morbidity in patients with cardiovascular disease. This effect can partly be related to a reduction in cholesterol levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as nephropathy, diabetes and hypertension. The purpose of this study is to investigate the effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular variables in patients witk chronic kidney disease.

Subjects will be examined on two examination days. 4 days prior to each examination day subjects are treated with either atorvastatin or placebo. During treatment periods subject are given a standardized diet.

On the examination days subject are given L-NMMA(L-NG-monomethyl Arginine citrate), a NO inhibitor, 6 mg bolus infusion followed by continuous 4 mg/kg/hr infusion for 1 hour. Renal function, central hemodynamic and vasoactive hormones are evaluated prior, during and after L-NMMA infusion.

Renal function is measured by renal clearance of 51Chromium-EDTA and urinary sodium, potassium and albumin concentration. Urinary excretion of protein from NCC, NKCC and ENaC will be measured to evaluate channel activity in the nephron.

Central blood pressure, pulse wave analysis, and augmentation index are measured using SphygmoCor® from Atcor.

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* minimum 20 years
* Chronic Kidney disease
* Estimated GFR (eGFR) between 30 and 90 ml/min

Exclusion Criteria:

* Nephrotic Syndrome
* Diabetes mellitus
* Anamnestic or clinical signs of significant heart, lung, lever, kidney, thyroid and brain disease
* Neoplastic disease
* Alcohol abuse,
* Drug abuse
* Pregnancy or nursing
* Blood donation within a month before examination
* Hgb \< 6,0