cyrilzakka/clinical-trials huggingface dataset:
A Study to Test the Effectiveness and Safety of a New Higher 40mg Dose of Copaxone® Compared to Copaxone® 20mg, the Currently Approved Dose

This is a study to test if a new higher dose of Copaxone is more effective in treating relapsing-remitting multiple sclerosis than the currently available 20 mg dose.


Eligibility Criteria:
Inclusion Criteria:

1. Clinically definite MS with disease duration (from onset) of at least 6 months.
2. Subjects must have had at least 1 documented relapse within the last year prior to study entry.
3. Subjects must have at least 1 and not more than 15 gadolinium (Gd)-enhancing lesions on the screening MRI scan.
4. Subjects must be relapse-free and not have taken corticosteroids (IV, IM and/or PO) within the 30 days prior to the screening visit.
5. Subjects must not have taken corticosteroids (IV, IM and/or PO) between the screening and baseline visits.
6. Subjects may be male or female. Women of child- bearing potential must practice a medically acceptable method of birth control. Acceptable methods include oral contraceptive, contraceptive patch, or double-barrier method (condom or IUD with spermicide).
7. Subjects must be between the ages of 18 and 50 years inclusive.
8. Subjects must be ambulatory, with a Kurtzke EDSS score of between 0 and 5 inclusive.
9. Subjects must be willing and able to give written informed consent prior to entering the study.

Exclusion Criteria:

1. Previous use of glatiramer acetate (oral or injectable).
2. Previous use of cladribine.
3. Previous use of immunosuppressive agents in the last 6 months.
4. Use of experimental or investigational drugs, including I.V. immunoglobulin, and/or participation in an investigational drug study within 6 months prior to study entry.
5. Use of interferon agents within 60 days prior to the screening visit.
6. Chronic corticosteroid (IV, IM and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry.
7. Previous total body irradiation or total lymphoid irradiation (TLI).
8. Pregnancy or breast feeding.
9. Patients who experience a relapse between the screening (month -1) and baseline (month 0) visits.
10. Any condition which the investigator feels may interfere with participation in the study, including alcohol and/or drug abuse.
11. A known history of sensitivity to mannitol.
12. A known sensitivity to gadolinium.
13. Inability to successfully undergo MRI scanning.
The Prescriptive Validity of a Novel Fall Risk Clinical Prediction Rule for People With COPD

This study has 3 objectives: (1) demonstrate the effectiveness of balance training for people with COPD, (2) determine which patients with COPD respond best to balance training, and (3) calculate clinically meaningful changes in balance for patients with COPD.

After receiving a detailed explanation of the study, including its risks and benefits, and providing informed consent, patients will be screened for eligibility criteria during a single 75-minute evaluation for participation in a physical therapy based pulmonary rehabilitation program. Those meeting eligibility criteria will be randomly assigned in blocks of four (by clinical site) in a single-blind manner (patients) in a 1:1 ratio to either balance training or a breathing and stretching exercise program. Both groups will receive respiratory muscle stretch exercises, aerobic exercise, strength training, and fall prevention education. The intervention phase will last 8 weeks, with patients being seen 3 times per week for 75 minute sessions supervised by a physical therapist or physical therapist assistant.

Eligibility Criteria:
Inclusion Criteria:

* having reported a fall in the past 5 years, or a near fall in the past year, or a score ≥ 9 on the Short Version of the Falls Efficacy Scale - International Version
* age ≥ 60 years
* both sexes
* spirometrically-confirmed COPD of all disease severity stages
* being independently ambulatory with or without a gait aid
* medical clearance by a physician to participate in pulmonary rehabilitation
* provision of informed consent.

Exclusion Criteria:

* having suffered a recent, severe COPD exacerbation (recent is 30 days or less prior to the study baseline)
* participation in a formal exercise program in the three months prior to the study baseline
* an inability by the patient to complete all study testing due to physical, psychological, communication-barrier, or other unanticipated reasons.
Music Therapy for Pain Management for Minor Procedures in Neonates.

The aim of this study is to assess the effectiveness and safety of music therapy as adjuvant therapy for pain management in newborns undergoing minor painful procedures. It is a prospective study and we plan to enroll 200 healthy full term newborns undergoing minor procedures (heel pricks). They will be randomly assigned to either control or music group. Those in music group will receive recorded Mozart lullaby music. Pain will be assessed using NIPS (Neonatal Infant Pain Scale) scoring tool. The potential benefit of the study would be identifying music a safe and efficient adjuvant therapy for pain management in newborns.

This randomized, controlled, double blinded, clinical trial will include full term neonates undergoing painful minor procedures (heel pricks) in the Nursery unit of Lincoln Medical and Mental Health Center.

One of the investigators involved in the study will obtain consent from the legal guardian and enroll the participants. All infants, regardless of the group that they are assigned, will receive similar standard non-pharmacologic method of pain relief which is 0.5 ml of 24% Sucrose, 2 minutes before undergoing heel prick. Pacifiers will be avoided to avoid potential confounding.

Subjects will be randomized into two different groups. Group A, music intervention group and group B, control group. In the music intervention group, a recorded instrumental lullaby music track called "Deep Sleep" from "Bedtime Mozart: Classical Lullabies for Babies", will be played for the neonates through smart phone speakers (maximum sound up to 60 A dB), starting 20 minutes before the heel prick, continuing through the procedure and for 5 minutes after the procedure. This music track has been selected based on previous research studies that showed effectiveness in neonatal pain management.

An investigator involved in the study will place the baby in a bassinet in a quite, dim lighted room. He/She will play the music for those babies in the music group and will NOT assess the NIPS. Another investigator wearing active noise cancelling Bluetooth headphones (for blinding) will enter the room at 5 minutes prior to the procedure and assess the NIPS at appropriate intervals: 5 minutes prior and at 1-minute interval during and after the procedure for 5 minutes. NIPS will be compared using appropriate statistical methods.

Eligibility Criteria:
Inclusion Criteria:

* \>37 weeks gestation babies

Exclusion Criteria:

* \<37 weeks gestation babies
* Major congenital anomalies
* Failed hearing screen
A Clinical Study of Islatravir and Its Interaction With Lamivudine (MK-8591-058)

The goal of this study is to learn what happens to the medication islatravir (ISL), in a healthy person's body over time--called a pharmacokinetic (PK) study. Researchers want to compare the amount of islatravir in the blood when it is taken alone as a single dose and when it is taken with multiple doses of another medication called lamivudine (3TC).


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is in good health before randomization
* Has a body mass index (BMI) ≥18 and ≤32 kg/m\^2

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Is a smoker and/or has used nicotine or nicotine-containing products (for example, nicotine patch and electronic cigarette) within 3 months prior to entering the study
Sympathetic Activity and Cardiometabolic Complications

Recent studies on catecholamine physiology have shown a direct correlation with arterial hypertension, overcoming the exclusive role in the diagnosis and follow-up of chromaffin tumors.

Nevertheless, in literature, few studies explore and reveal the utility of testing metanephrines for the evaluation of sympathetic activity and its associated cardiometabolic complications in patients with essential hypertension.

Catecholamines (noradrenaline, adrenaline and dopamine) are adaptive and maladaptive stress hormones.

In the classic "fight or flight" mechanism, they activate behavioral and physiological processes that facilitate the overcoming of stress; for instance, challenged by a physical stressor, an organism responds to the threat either fighting and prevailing or accepting defeat and fleeing in avoidance.

In the pathological context, an excessive catecholamine secretion is typical of the chromaffin tissue tumors, determining a clinical picture characterized by blood pressure elevation, tachycardia, anxiety, pallor, sweating and headache.

COMT enzyme catalyzes the O-methylation of the 3-hydroxyl group of catecholamines. The O-methylated derivatives of noradrenaline, adrenaline and dopamine are normetanephrine, metanephrine and 3-methoxytyramine, respectively. The term "metanephrines" is generally used to collectively refer to the first two compounds.

Compared to catecholamines, metanephrines are characterized by longer half-life and more stable levels over time. Their superior accuracy for the diagnosis and follow-up of pheochromocytoma and paraganglioma (PPGL) has been widely proved.

Excluding patients with PPGL, however, metanephrines can be more broadly considered as reliable markers of the whole sympathetic system activity; therefore, their levels may be hypothesized to be associated to a higher rate of concurrent cardiometabolic complications and, if so, could be useful for the stratification of cardiovascular risk.

Eligibility Criteria:
Inclusion Criteria:

* Measurement of 24h urinary metanephrines at the laboratory of "City of Health and Science" hospital in Turin between 2007 and 2015
* Availability of contextual clinical patient data as collected in prospective registries of Piedmont region

Exclusion Criteria:

* Diagnosis of pheochromocytoma or paraganglioma (at the time of urinary metanephrines collection or within the following 5 years)
* Diagnosis of other forms of secondary hypertension
* Previous cardiovascular or cerebrovascular event
* Chronic heart failure
* eGFR \< 50 ml/min (according to CKD-EPI)
* Liver cirrhosis
* Acute conditions and/or hospitalization in ICU (at the time of urinary metanephrines collection)
* Assumption of acetaminophen during the day before the 24-hour urine collection
* Therapy with labetalol
* Therapy with sotalol
* Therapy with alpha-methyldopa
* Therapy with MAO inhibitors
* Therapy with tricyclic antidepressants
* Therapy with buspirone
* Therapy with phenoxybenzamine
* Therapy with sulfasalazine
* Therapy with L-Dopa
* Therapy with sympathomimetic drugs or other vasopressors
* Alcohol abuse
* Cocaine abuse
Multiple-Dose Study of VGX-1027 in Healthy Subjects

The purpose of this study is to evaluate the safety profile, tolerability and pharmacokinetics following multiple oral doses of 40mg to 200mg VGX 1027 in healthy subjects administered for 5 days.

This study will evaluate:

* The safety and tolerability of multiple oral doses of VGX 1027 in the range of 40 to 400mg.
* The pharmacokinetics of VGX 1027 in healthy subjects following the first oral dose (Day 1) and at steady state (Day 5).

Eligibility Criteria:
Inclusion Criteria:

* Must give written informed consent.
* Healty subjects as determined by no clinically significant deviation from normal as judged by the investigator in medical history, physical examination, ECGs and clinical laboratory evaluations.
* Body Mass Index (BMI) of 18 to 30kg/m2 ±0.5kg/m2 inclusive.

Exclusion Criteria:

* Women who are of childbearing potential.
* Women who are pregnant or breastfeeding.
* Women with a positive pregnancy test on enrollment or prior to study drug administration.
* Male subjects who are unwilling to agree to practice barrier contraception during study participation and 3 months following dosing.
* Any significant acute or chronic medical illness
* Current or recent (within 3 months) gastrointestinal disease that may impact the absorption of the drug.
* Any major surgery within 4 weeks of enrollment.
* Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of enrollment.
* Blood transfusion within 4 weeks of enrollment.
* Inability to tolerate oral medication.
* Inability to be venipunctured and/or tolerate venous access.
* Recent (within 6 months) drug or alcohol abuse.
* History of bleeding disorder.
* History of head trauma or seizures.
* Any other sound medical, psychiatric and/or social reason as determined by the Investigator.
* Evidence of organ dysfunction or any clinically significant deviation from normal in vital signs, physical examination, ECG, or clinical laboratory determination.
* Positive urine screen for drugs of abuse
* Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, HIV 1/2 antibody
* History of any significant drug allergy
* Exposure to any investigational druge within 4 weeks prior to enrollment or greater than 4 weeks for investigational drugs that may have a longer half life.
* Use of any prescription drugs, over the counter acid controllers within 4 weeks prior to enrollment.
* Use of any other drugs, including over the counter vitamins, medications and/or herbal preparations within 2 weeks prior to enrollment
* Use of oral, injectable or implantable hormonal contraceptive agents within three months prior to enrollment
* Use of alcohol containing beverages within 1 week prior to enrollment
* Use of grapefruit containing products within 1 week prior to enrollment
* Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness
Catheter Orifice Configuration (Six-hole Versus End-hole) on Post-operative Analgesia After Total Knee Arthroplasty.

Multiorifice catheters have been shown to provide superior analgesia and significantly reduce local anesthetic consumption compared with end-hole catheters in epidural studies. This prospective, blinded, randomized study tested the hypothesis that, in continuous femoral nerve block (CFNB) under ultrasound guidance, multiorifice catheter would reduce local anesthetic consumption at 24h compared with end-hole catheter.

Eighty adult patients (aged ≥18 years) scheduled to undergo primary total knee arthroplasty under a combination of continuous femoral nerve block (CFNB), sciatic nerve block and general anesthesia were randomized to CFNB using either a 3-pair micro-hole (Contiplex, BRAUN®, 20G - 400 mm) or an end-hole (Silverstim VYGON®, 20G - 500 mm) catheter. Once the femoral catheter was sited, a bolus of 20 mL lidocaine 1% was injected. An electronic pump then delivered an automated 5 mL bolus of ropivacaine 0.2% hourly, with 10 mL self-administered patient controlled analgesia boluses.

Eligibility Criteria:
Inclusion Criteria:

* every patient accepting a conitnuous femoral nerve catheter

Exclusion Criteria:

* pregnancy,
* any contraindication to peripheral nerve blockade,
* pre-existing peripheral nerve neuropathy,
* allergy to LA (study medications),
* ASA score ≥4,
* neurologic or neuromuscular disease,
* psychiatric disease,
* renal failure,
* hepatic failure,
* chronic opioid therapy,
* NSAID contraindication,
* inability to use a patient controlled analgesia (PCA) device, g
* enu valgum,
* infection at the injection site or
* withdrawal of consent.
Investigating Immune Mechanisms in Atopic Eczema

The aim of this study is to investigate the mechanisms behind the immune dysfunction that occurs in atopic eczema (or atopic dermatitis).

Atopic eczema is a chronic inflammatory skin disease that affects 15-20% of children and 12% of adults and leads to significant loss of quality of life. It results from a complex interaction of genetic and environmental factors, and is characterised by dysregulation of the cutaneous immune system. Specifically, in the skin of eczema patients there is a persistence of T lymphocytes (a crucial cell involved in regulating the immune system), and an overproduction of certain cytokines (signalling molecules that are essential in producing inflammatory responses).

The study intends to investigate the causes of atopic eczema by examining the number, characteristics and function of T lymphocytes in the skin and the blood of eczema patients, as well as the types of cytokine they produce. To achieve this the investigators aim to take skin biopsies, tissue fluid (from induced skin suction blisters) and blood samples from adult eczema patients and healthy controls for analysis. Additionally, in these groups a cutaneous immune response will be initiated by injecting tuberculin protein purified derivative (the Mantoux test) into the skin, to further investigate how the behaviour of T lymphocytes varies between eczema patients and healthy controls.

This research is important in view of the high prevalence of atopic eczema in the population. An improved understanding of its causes will hopefully lead to more effective treatments for this condition in future.

Eligibility Criteria:
Inclusion Criteria:

* History of atopic dermatitis (according to United Kingdom Working Party's diagnostic criteria)
* Previous Bacillus Calmette-Guerin vaccination

Exclusion Criteria:

* Unable to give written informed consent
* Previous history of hypersensitivity to local anaesthetic (for skin biopsy) or tuberculin PPD (for skin test)
* Pregnancy or breast feeding
* History of tuberculosis
* Recent infection or immunisation (within last month)
* Known immunodeficiency e.g. HIV infection, primary immunodeficiency, any history of chemotherapy or radiotherapy
* Systemic steroids within the last month or any other immunosuppressive medications (eg. methotrexate, ciclosporin or azathioprine) within the previous 3 months
* Phototherapy within the previous 28 days
* Treatment with potent topical corticosteroids or tacrolimus ointment within the previous 7 days
* Significant co-morbidity (diabetes, renal failure, liver failure, heart failure)
* On warfarin or known bleeding disorder
* History of neoplasm in last 10 years (not including basal cell carcinoma)
* Previous keloid scarring
The Social Gradient of Urban Noise Pollution and Its Effect on Pediatric and Adult Health

The investigators pilot test an intervention to understand the spatial-temporal distribution of aggregated environmental noise exposure in Philadelphia and its impact on health.

Noise pollution - sound created by human activities considered harmful to health - represents an oft- cited public concern, yet has taken a back seat to other environmental hazards. A limited number of observational studies demonstrate that chronic environmental noise exposure is associated with poor outcomes in adults and children, including cardiovascular disease, poor mental health, impaired sleep, and reduced cognitive performance in children. Further investigation and direct measurement at a community-level is needed to not only better understand the spatial-temporal distribution of aggregated environmental noise exposure and its impact on health, but also to lay the groundwork to develop and evaluate needed noise-reducing interventions.

The broad objective of this pilot proposal is to examine the social gradient of noise at a micro-spatial level in Philadelphia and evaluate its impact on the health of pediatric and adult local residents. Our multi-disciplinary team uniquely combines emerging digital and remote-sensing technologies, and expertise in place- based interventions to achieve the following specific aims: (AIM 1) Document the spatial-temporal distribution of environmental noise exposure across 24 Philadelphia neighborhoods with low, medium, and high socioeconomic status (SES), and (AIM 2) Explore the feasibility of evaluating the relationship between noise exposure and biometric health data - including sleep quality, cardiovascular metrics, and neurobehavioral profiles in pediatric and adult participants.

Eligibility Criteria:
Inclusion Criteria:

* Residents living within 0.25 miles of the location of an external sound device
* Adults 18 years and older
* Children between 11-17 years of age
* Able to understand and respond to an oral interview in English

Exclusion Criteria:

* Unwilling to wear an Actigraphy device
* Adults unwilling to take blood pressure
Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine in Uterine Cervical Cancer

The scope of the trial is to assess the efficacy of the association gemcitabine-cisplatin + radiotherapy followed by an adjuvant chemotherapy


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years old
* Cervical uterine cancer (epidermoid or adenocarcinoma, stage:from IB\> or = 4 cm to IV, according to FIGO classification) histologically proven
* Measurable lesions,clinically and by MRI assessed
* PS-WHO \< or = 2 ou Karnofsky Index \>70 per cent
* Life expectancy \> 3 months
* Hematologic function: leukocytes \< or = 3 G/l, polynuclear neutrophil leukocytes \> or = 1.5 G/l, platelets \> or = 100 G/l, hemoglobin \> or = 10 g/dl
* Hepatic function: ASAT and ALAT \< 2.5 ULN
* Renal function: creatininemia \< 1.5 ULN, clearance \> 60 ml/min
* No prior chemotherapy or radiotherapy
* Contraception
* Written informed consent signed

Exclusion Criteria:

* Stage IB \< 4 cm or IVB
* Other histology than epidermoid or adenocarcinoma
* Distant metastases, including sus-clavicular adenopathy
* Contraindication to MRI
* Pregnant or lactating woman
* Auto-immune disease
* Peripheric neuropathy, autograft or homograft, psychiatric disease
* Prior cancer (except cutaneous basocellular carcinoma and uterine cervical carcinoma in situ)
* Active infection
* Other clinical trial with an experimental drug
* Known positive serology (HIV, HbC, HbS)