cyrilzakka/clinical-trials huggingface dataset:
Arousal Analysis by Pulse Wave Amplitude in Patients With Obstructive Sleep Apnea

Photoplethysmography is an easy non-invasive method to detect the pulse wave amplitude (PWA) from a finger. This can be measured using the Somnocheck micro system. A pulse wave amplitude decrease (PWAD) is considered to be a marker for autonomic activation. Detecting the PWAD is a surrogate marker for waking reactions (arousal) which eventually will contribute to assess sleep disruption and resulting performance deterioration. Arousal and performance deterioration and its possible improvement under continuous positive airway pressure (CPAP) therapy will be determined in this study.

Patients from the sleep laboratory with verified obstructive sleep apnea syndrome (OSAS) will be asked to participate in this study.

A device is used to determine autonomic arousal over night (SOMNOcheck micro). The Somnocheck micro records oxygen saturation as well as pulse frequency and breathing, and calculates an autonomic arousal index (AAI). Somnocheck measurements will take place in two nights (baseline and with CPAP) and parallel to a standard polysomnography (PSG). The PSG provides data to analyze the arousal frequency according to ASDA rules, which will then be compared to the AAI.

Performance is determined twice (prior and after CPAP therapy) by the use of a steering simulator programme (DASS). Differences in arousal will be correlated with differences in performance (deviation from the road, reaction time). The subjects are also asked to fill out the Epworth Sleepiness Scale (ESS) twice, prior and after therapy. Aim is to compare Somnocheck and PSG measurements and daytime sleepiness with DASS and ESS.

Eligibility Criteria:
Inclusion Criteria:

* Obstructive Sleep Apnea (AHI \>5)

Exclusion Criteria:

* Suspected acute cardiac, pulmonary or neurologic disease
Effect of Bathing on Physiological Parameters, Skin, Bilirubin and Comfort Levels in Infants Receiving Phototherapy

The aim of this study is to determine the effect of bathing on physiological parameters (heart rate, body temperature and oxygen saturation), skin, bilirubin and comfort level in infants receiving phototherapy.

Neonatal jaundice (hyperbilirubinemia) causes a yellowish discolouration of the sclera and skin due to increased levels of bilirubin in the blood. Jaundice develops in 60% of term babies and 80% of premature babies in the first week of life. Currently, the appropriate treatment option for neonatal jaundice is phototherapy. Phototherapy treatment reduces bilirubin concentrations through various photochemical reactions that allow bilirubin to be excreted more easily. However, phototherapy treatment is associated with short-term side effects including transient skin rashes, diarrhoea, hyperthermia and dehydration.

Physiological reasons such as the weak connection between the epidermis and dermis layer in the skin of the newborn, the pH value of the skin being close to neutral or alkaline, and the low melanosome production increase the susceptibility of the newborn to infection and skin damage. Invasive interventions, use of antiseptics, phototherapy and various instruments may disrupt the skin integrity of the newborn. Therefore, all newborns receiving treatment and care in the neonatal intensive care unit are at risk in terms of skin integrity.

In the majority of newborn infants; jaundice develops, which can affect the newborn neurologically, motor and hearing if left untreated,. Phototherapy devices are widely used today for the treatment of jaundice. Phototherapy devices used in the treatment of jaundice have side effects such as skin rashes, diarrhea, dehydration and hyperthermia. In the literature reviewed, results were found that bathing the newborn reduces phototherapy rashes, lowers the bilirubin level and increases the comfort of the newborn. Also in the literature; There are studies showing that one of the most suitable bathing methods for a newborn is bathtub bathing and that bathing with baby shampoo is not harmful to the newborn.

Eligibility Criteria:
Inclusion Criteria:

* Born at 35-41 gestational weeks
* Indirect hyperbilirubinaemia diagnosed at 24 hours of birth or more,
* No health problems,
* Indication for phototherapy treatment
* Stable vital signs
* Whose parents agreed to participate in the study

Exclusion Criteria:

* Newborns with ABO and Rh incompatibility,
* Direct diagnosis of hyperbilirubinaemia,
* Congenital anomaly,
* With skin lesions
CONtrolled Focal Fibrous Band Release Method Study

Study to evaluate the safety and effectiveness of the Avéli medical device to reduce the appearance of cellulite.

Multi-center, single-arm clinical study to evaluate the safety and effectiveness of the Avéli device in reducing the appearance of cellulite.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe cellulite

Exclusion Criteria:

* Body Mass Index ≥30.0
Symptom-limited Stair Climbing Test in Heart Failure

Aims: To assess the efficacy of symptom-limited stair-climbing test (SLSCT), in determining the exercise capacities of patients with chronic heart failure (CHF) in comparison with cardiopulmonary exercise test (CPET) and 6-minute walk test(6MWT) and to interpret the results according to the clinical status of the patients.

Methods: Thirty-one patients, aged 50-75 years, with stage II-III CHF according to the New York Heart Association Classification and left ventricular ejection fraction (LVEF) of ≤45% were included. The demographic and clinical characteristics of the patients were recorded. Exercise capacity was assessed by SLSCT, 6MWT, and CPET. The duration of patients' performance in the test, reasons for ending the test and predicted maximal oxygen consumption (VO2max) were recorded. Heart rate (HR), blood pressure (BP), dyspnoea severity \[Modified Borg Scale (MBS)\] and peripheral oxygen saturation were recorded. Pulmonary functions were assessed by spirometry.


Eligibility Criteria:
Inclusion Criteria:

* 50-75 years of age
* NYHA stage II-III
* LVEF of 45% or less
* Independently walking and climbing stairs
* Volunteer to participate in research

Exclusion Criteria:

* Any acute or chronic condition that would limit exercise capacity other than CHF
* Insufficient mental status to perform tests and surveys
* Orthopaedic problem limiting exercise test in lower extremity
* Severe obesity or there is a secondary cause for obesity
* Uncontrolled cardiac arrhythmia
* Unstable angina
Light Therapy for the Treatment of Back Pain in Pilots (LLL&Pilots)

Back pain is a common complaint among pilots. Current treatments include physiotherapy and chiropractic manipulations. Low-level laser irradiation (LLLI) in the visible to near-infrared range was shown to reduce neck and low back pain.

The purpose of the study is to evaluate the efficacy of Light Therapy for treatment of back pain in pilots.

Background: Lumbar spine disorders are common conditions in pilots of various aircraft with etiology related to sub-optimal ergonomics, exposure to G-forces, the weight of the head gear and exposure to extensive vibrations. Current treatments include physiotherapy and chiropractic manipulations. Low-level laser irradiation (LLLI) is a non-ionizing, non-thermal irradiation within the visible to near infrared range of the light spectrum. LLLI has been used widely for alleviation of pain in inflammatory processes and acceleration of wound healing. A variety of clinical studies show that LLLT in the near infrared range may be useful in the treatment of back pain.

Objective: To evaluate the efficacy of Light Therapy for treatment of back pain in pilots.

Study design: Prospective, randomized, controlled double blind. Volunteers will receive biweekly physiotherapy treatment for 3 weeks. In addition to the physiotherapy treatment, half the volunteers will receive light therapy and half sham irradiation. Study evaluations will include physical examination by an orthopedic surgeon, subjective pain level by visual analogue scale, validated low back functional questionnaires, a generic functional questionnaire, and patient satisfaction scores. Volunteers will be invited for evaluations at 1 and 3 months after the final treatment.

Eligibility Criteria:
Inclusion Criteria:

* Pilot (current)
* Level of pain - moderate to severe low back pain (≥40 on the pain VAS)

Exclusion Criteria:

* Low back pain due to non-traumatic etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, cauda equinal syndrome).
* Pregnant
* Recent (up to 1 year) history of trauma
* Current chronic pain other than low back pain
* Physical disability that prevents the patient to lie down/get up
Insomnia Prevention in Children With Acute Lymphoblastic Leukemia

The goal of this research study is to understand the acceptability and feasibility of the Sleep ALL Night intervention among children with Acute Lymphoblastic Leukemia (ALL) in hopes of improving the discussion of sleep disorders with clinical providers.

The name of the intervention used in this research study is: Sleep ALL Night, which is a sleep intervention program comprised of an action plan tool and psychoeducational website.

This research study is to conduct a single-arm pilot study to determine the acceptability and feasibility of Sleep ALL Night for children with Acute Lymphoblastic Leukemia (ALL).

Participation in this research study is expected to last 1 month.

It is expected about 30 children will take part in this research study.

The National Cancer Institute (NCI) is providing funding for this research study through a grant.

Eligibility Criteria:
Inclusion Criteria:

* Patient in the Maintenance Phase of therapy on or as per DFCI 16-001 and has completed at least two cycles of maintenance therapy to allow adequate recovery from the more intensive Consolidation phase.
* English or Spanish speaking child and primary caregiver (parent/guardian).
* Child aged 4-12 years.

Exclusion Criteria:

* Primary team declines permission to approach.
* Children with critical illness (defined as ICU admission)
Microbiome Sampling in GI Disease With a Focus on Small Intestinal Microbial Assessment

GI disorders are influenced by the gut microbiome. To date, sampling of the small intestine in GI disorders has been limited. The investigators plan to sample the small intestinal contents during endoscopy for research purposes.

Current guidelines (AGA Clinical Practice Update, 2020) report the definition of SIBO as a clinical entity lacks precision and consistency; it is a term generally applied to a clinical disorder where symptoms, clinical signs, and/or laboratory abnormalities are attributed to changes in the numbers of bacteria or in the composition of the bacterial population in the small intestine. To date, there is unlimited knowledge regarding the diagnostic criterion which has been limited by nonspecific and nonsensitive testing such as breath tests. Breath tests have a limited use in patients with IBS-D who inherently have increased gut transit time rendering the testing invalid for accurately measuring small intestinal bacteria. Additionally, the relationship between SIBO and symptoms in patients without obvious risk factors (such as anatomical changes due to surgery) is unknown. The investigators study aims to investigate the microbial landscape of the small intestine in healthy patients and those with GI disease (suspected or diagnosed) undergoing an upper endoscopy by collecting an aspirate of patient small intestinal fluid and studying it.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18years
* Patients seen at Stanford University Digestive Health Center who are scheduled for an upper endoscopy as part of their Standard Of Care

Exclusion Criteria:

Children (under age 18years) Pregnant Women and Fetuses Neonates (0 - 28 days) Impaired Decision Making Capacity
Nursing Consultation in Out-patient Clinics for Patients With Inflammatory Rheumatic Disease

Evaluate the effectiveness and acceptability of care given by nurse specialists in out patient clinics, through a randomized controlled study.

This study is part of a national multicenter study (NOR-DMARD) that aims to measure the longterm safety and effectiveness of disease modifying therapies in inflammatory arthropathies. The Nor-Dmard study is a comparative, phase IV, longitudinal, observational study. All patients starting a DMARD regime are enrolled. Patients from two clinics (different parts of Norway) will be randomised to receive follow-up care from either a clinical nurse or a rheumatologist.

The primary outcome measure is patient satisfaction measured by Leeds Satisfaction Questionnaire.

The secondary outcome is effectiveness measured by Coping (CORS),Health related quality of life (SF-36) and Disease activity (MHAQ, DAS-28).

Eligibility Criteria:
Inclusion Criteria:

* Patients with inflammatory arthropathies monitored after starting disease modifying antirheumatic drugs.
Does Endometrial Injury Improve Intrauterine Insemination Outcome?

The investigator suggests that local endometrial injury using pipelle catheter performed in the follicular phase (cycle day 5, 6 or 7) of the stimulation cycle may improve the pregnancy rates among patients undergoing intrauterine insemination.

In a selected group of patients with repeated implantation failure, endometrial injury in the preceding cycle may improve ICSI outcome.

Little is known about the efficacy of this procedure in improving intrauterine insemination outcome.

Also little is known about the effect of this procedure if done in the stimulation cycle weather in ICSI or intrauterine insemination cycles.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 38 years.
* patent fallopian tunes.
* mild male factor.
* anovulation.
* unexplained infertility.

Exclusion Criteria:

* indications for ICSI.
* evidence of pelvic inflammatory disease.
An Open, Multicenter Study of Foscarnet Treatment of Acyclovir-Resistant Herpes Simplex Virus in Patients With the Acquired Immunodeficiency Syndrome and Other Immunodeficiencies

To evaluate the safety and efficacy of intermittent intravenous (IV) foscarnet in the treatment of acyclovir-resistant herpes simplex virus (HSV) infections in AIDS patients and other immunocompromised patients. To evaluate the necessity, efficacy, and safety of IV maintenance foscarnet therapy in preventing recurrent disease. To confirm the pharmacokinetics of intermittent induction and maintenance IV regimens.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Cyclosporine.

Patients must have AIDS as defined by the CDC, or be patients with other immunocompromised states (transplant patients; other hematologic malignancies with recognized cell-mediated immune deficiency), and have herpes simplex virus (HSV) infection documented by culture and in vitro resistance to acyclovir by standard laboratory susceptibility or suspected resistance to acyclovir after an acyclovir treatment failure in which acyclovir was administered for at least 2 weeks intravenously at doses of 30 mg/kg/day (or a comparative dose adjusted for renal insufficiency). In vitro susceptibility data must be pending in the latter case.

* Patients must be able to give informed consent.
* Patients \< 18 years of age may participate with the consent of parent, guardian, or person with power of attorney, or through the provisions of state laws regarding emancipated minors.
* Expected survival of at least 6 months.

Prior Medication:

Allowed:

* Cyclosporine.
* Ganciclovir.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Known allergy to foscarnet.
* Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).

Concurrent Medication:

Excluded:

* Any potentially nephrotoxic agent (except cyclosporine).
* Immunomodulators.
* Biologic response modifiers.
* Investigational agents.

Patients with the following are excluded:

* Known allergy to foscarnet.
* Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).

Prior Medication:

Excluded within 7 days of entry:

* Any potentially nephrotoxic agent (except cyclosporine).
* Excluded within 14 days of entry:
* Immunomodulators.
* Biologic response modifiers.
* Investigational agents.
Pericapsular Nerve Block in Proximal Femoral Fractures

Proximal femoral fractures commonly occur above 50 years and regional anesthesia could be a complement in the perioperative treatment of the patients. The use of pericapsular nerve group block (PENG Block) has been proposed to reduce pain. However, no studies have explored the efficient of the systemic analgesia associated with PENG Block in functional limitation in the preoperative period. In this sense, the main goal of this study is to evaluate the effectiveness of systemic analgesia associated with PENG Block in patients with proximal femoral fractures in the period preceding the surgical procedure.

Focus on functional capacity will be measured by the Activity Measure for Post-Acute Care (AM-PAC) short version of the "6 Clicks", pain intensity will be assessed using the numerical rating scale, and opioid consumption. This study will include 21 patients admitted to the Emergency Room with proximal femoral fractures.

Eligibility Criteria:
Inclusion Criteria:

* patients with unilateral proximal femoral fractures admitted to the emergency room of the Hospital Sírio-Libanes,
* aged 18-105 years
* with the American Society of Anesthesiology (ASA) physical status I, II, or III.

Exclusion Criteria:

* allergy to metamizole and/or ropivacaine
* history of mental disorders
* presence of chronic pain as assessed using the Douleur Neuropathique 4 (DN4) questionnaire
Efficacy and Safety of Insulin Detemir in Type 1 Diabetes

This trial is conducted in Europe.

The aim of this trial is to compare the efficacy and safety of insulin detemir and insulin NPH in adults with type 1 diabetes on blood glucose control.


Eligibility Criteria:
Inclusion Criteria:

* Duration of type 1 diabetes for at least 12 months
* BMI below 35 kg/m2
* HbA1c between 7.0-12.0%
* Current treatment with preprandial short acting insulin and insulin NPH once or twice daily for at least 6 months
* Fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the Investigator

Exclusion Criteria:

* Known or suspected allergy to trial product or related products
* Previous participation in this trial
* Receipt of any investigational products within the last 2 months prior to this trial
* Drug or alcohol dependence
* Pregnancy, breast-feeding or intention of becoming pregnant
Comparison of Three Methods of Taking Temperatures in the Well Baby Nursery

Body temperature measurement is one of the standard vital sign measurements in newborn babies in order assess their health status. Temperatures are taken on a regular basis throughout the newborn's stay on the well-baby floor. A temperature that is elevated above the normal range for age or depressed below the normal range for age may be a sign of illness in a newborn. There are many methods that may be used to record this temperature. Traditionally, axillary (under the arm) and rectal (in the rectum) sites have been used. Recently, a new method of temperature measurement has become available. Temporal artery thermometers are a non-invasive method to measure the baby's temperature by means of a light that is shone on the forehead that can read your baby's temperature quickly. It is not clear whether this method is accurate in the newborn period.

The purpose of this study is to evaluate the accuracy of temporal artery temperature measurement. This will be achieved by observing the axillary measurement, rectal temperature measurement, and temporal artery temperature measurement taken at approximately the same time in each infant. These measurements will be compared to each other to determine if temporal artery thermometry is as reliable a measurement as rectal and / or axillary temperature measurements.

We plan to compare

Hypothesis: Temporal artery thermometry of the immediate newborn infant is an accurate measurement of temperature in this age group.


Eligibility Criteria:
Inclusion Criteria:

* term newborns \>/= 37 weeks gestational age
* late preterm infants \>/= 35 weeks gestational age
* admitted to the well baby nursery following delivery
* \< 24 hours of age

Exclusion Criteria:

* Infants \< 35 weeks gestational age
* Infants currently under a radiant warmer or who have been under a radiant warmer \< 1 hour prior to temperature measurement.
Refractory Diffuse Large B-cell Lymphoma

In the rituximab era, one-third of diffuse large B-cell lymphoma (DLBCL) patients experience relapse/refractory disease after first-line anthracycline-based immunochemotherapy (IChemo). Optimal management remains an unmet medical need. The aim of this study was to report the outcomes of a cohort of refractory patients according to their patterns of refractoriness and the type of salvage option. The investigators performed a retrospective analysis, which included 104 DLBCL patients treated at Lyon Sud University Hospital (2002-2017) who presented with refractory disease. The investigators retrospectively evaluated the outcomes of a cohort of 104 refractory patients according to their patterns of refractoriness and the type of salvage option.


Eligibility Criteria:
Inclusion Criteria:

-≥18 years of age

* diagnosed with DLBCL at Lyon Sud University Hospital (LSUH) from January 2002 to January 2017
* presented with refractory disease in response to front-line therapies
* including anthracycline-based chemo and a monoclonal anti-CD20 antibody

Exclusion Criteria:

* Patients with a history of indolent lymphoma,
* Patients with a primary central nervous system (CNS) lymphoma or immunosuppression-related lymphoma
A New Adaptive Feeding Plan for Newborns

The purpose of this clinical trial is to identify the infant formula(s) for which the investigators get the closest gut maturation index compared to the one they get with breastfed babies.


Eligibility Criteria:
Inclusion Criteria:

* Healthy newborn infant
* Full term infant (≥ 37 weeks gestation; \< 42 weeks gestation)
* Birth weight from 2500g to 4500g
* For the formula-fed groups: babies whose mothers elected not to breastfeed at all
* For the breastfed group: babies whose mothers elected to exclusively breastfeed for at least 2 months
* Newborn whose parents / caregivers can be expected to comply with the protocol
* Study explained and written information given
* Informed consent signed

Exclusion Criteria:

* Mother who had antibiotics in the 7 days preceding delivery
* Caesarian section
* Multiple birth
* Congenital illness or malformation that may affect normal growth
* Significant pre-natal and/or post-natal disease
* Newborn participating in another clinical trial
Evaluation of Corneal Epithelial Thickness Mapping

Optovue has developed a new feature for mapping corneal epithelial thickness. The purpose of the study is to evaluate the accuracy and repeatability of the epithelial thickness measurement. Consented subjects will undergo a series of cornea measurements using optical coherence tomography (OCT) that will be used for analysis.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Able and willing to provide consent
* Able and willing to complete the required examinations
* DRY EYE GROUP ONLY: Clinical diagnosis of dry eye
* CONTACT LENS GROUP ONLY: Regular contact lens wear

Exclusion Criteria:

* History of ocular surgery
* History of laser refractive surgery
* History of cataract surgery
* DRY EYE GROUP ONLY: Corneal pathology not associated with dry eye
* CONTACT LENS GROUP ONLY: Corneal pathology including dry eye
* NORMAL GROUP ONLY: History of contact lens wear or dry eye or corneal pathology