cyrilzakka/clinical-trials huggingface dataset:
PAP Systems Internal Clinical Studies (ICS)

This is a pre-market study for ongoing product development aiming to explore the usability and performance of the study PAP systems to guide product development.

This is an open label, prospective, randomized cross over (or single arm) study designed to support the development of new accessories for PAP devices. This generic protocol provides a framework methodology for how these ongoing studies will be conducted. This protocol then is used in a number of smaller sub-studies, each of which will have their own sub-protocol outlining the exact specifics of the study.

The studies could be run face-to-face or remotely.

Participants are healthy volunteers who are ResMed employees. Recruitment will be done via emails. Participants will be explained the details of the trial and those who wish to take part will be invited to a selected site for the first study visit.

Visit 1: Participants will provide written informed consent. Participants will be shown the PAP systems and trial them for fit and comfort. Participants may be asked initial questions on their first thoughts on the PAP systems. If the participant and assessor are happy to proceed, the participants will use the loan PAP system for trial.

Visit 2: After trialing the PAP systems, participants will be asked to complete a questionnaire regarding the appeal, comfort, and usability of the PAP system(s). Depending on sub-study protocol, participants will then take the second PAP system home to test.

Visit 3: The participant will return the loan PAP system to the assessor. The participants' questionnaire responses will be reviewed. This concludes the participation in the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants who are employees of ResMed
* Participants shall be volunteers
* Participants willing to give written informed consent
* Participants who ≥ 18 years of age
* Participants willing and able to complete the specified tasks

Exclusion Criteria:

* Participants who are or may be pregnant.
* Participants with a preexisting lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury.
* Participants believed to be unsuitable for inclusion by the researcher.
* Participants who or whose bed partner has implantable medical devices which may contraindicate against masks with magnetic clips (exclusion criteria for study masks with magnetic clips only)
Effect of Sitagliptin on Short-Term Metabolic Dysregulation of Oral Glucocorticoid Therapy

The investigators hypothesize that sitagliptin will significantly reduce impairments in insulin secretion and insulin resistance resulting from short-term oral glucocorticoid therapy.

The investigators plan to conduct a prospective, randomized, double-blind, placebo-controlled parallel arm crossover study comparing insulin secretion and insulin resistance in subjects with impaired fasting glucose on oral glucocorticoid therapy + placebo versus subjects on oral glucocorticoid therapy + sitagliptin. For the oral glucocorticoid therapy, we plan to use dexamethasone (dex) 2.5 mg daily. We chose dex for known glycemic effects, improved compliance, and once daily dosing.

Previous studies have shown that in humans, glucocorticoid-induced insulin resistance develops within 4 hours with infused drug at high dose (methylprednisolone 500 mg x single infusion) and does not change with duration of drug therapy of up to 3 months.10 Furthermore, more modest doses over a short duration (dex 2.0 mg orally daily x 2 days) have been shown to decrease insulin-mediated glucose disposal.11 12 Thus, studying acute effects of oral dex at 2.5 mg daily x 7 days should be more than adequate to achieve impaired glucose-mediated insulin secretion and impaired insulin-mediated glucose disposal.

In order for sitagliptin to have the desired effect, drug should be administered for at least 7 days (5 half-lives plus 40% more for margin of error). We plan to study subjects with impaired fasting glucose or impaired glucose tolerance as they would likely be candidates for DPP-IV therapy in the future and would be likely to have impaired insulin secretion and impaired glucose disposal amenable to DPP-IV therapy.

A total of 10 participants were enrolled in this study. Participants were given 2.5 mg dexamethasone daily plus either placebo tablet or sitagliptin daily for 8 days with a washout period prior to crossover. The order of study drug administration was randomized. Participants underwent blood sampling, mixed meal testing (MMT), and intravenous glucose tolerance testing (IVGTT) before and after each study period.

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* impaired fasting glucose
* We will stratify for weight and age.

Exclusion Criteria:

* Known Type 2 DM
* Severe disease preventing participation in study
* On chronic steroids for any reason
* Already taking DPP-4 inhibitor
The Use of Oxytocin, Carbetocin and Buccal Misoprostol in Patients Undergoing Elective Cesarean Section (CS)

The use of Oxytocin, Carbetocin and buccal misoprostol in patients undergoing elective Cesarean Section

The use of Oxytocin, Carbetocin and buccal misoprostol in patients undergoing elective Cesarean Section in the prevention of uterine atony and postpartum hemorrhage (PPH) after caesarean section.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or more.
2. Gestational age of pregnancy of 37 completed weeks or more.
3. Written and signed informed consent by the patient to participate in the study.

Exclusion Criteria:

1. fetal or maternal distress where, due to time constraints, it will not possible and/or appropriate to recruit or randomize.
2. Women undergoing caesarean section with general anesthesia are also excluded, because carbetocin is licensed for use with regional anaesthesia only.
3. Women planned to have any other type of uterine incision other than transverse lower segment.
4. Women with HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), eclampsia, and epilepsy .
5. Women with placental abruption are excluded because there is a higher risk of hemorrhage with this condition and it was therefore felt to be inappropriate to recruit these women.
6. Women with thrombocytopenia, known coagulopathies, or receiving anticoagulant therapy.
7. Women with history of significant heart disease, a history or evidence of liver, renal, vascular disease or endocrine disease (other than gestational diabetes).
8. Women with history of hypersensitivity to oxytocin or carbetocin.
9. Women with any severe allergic condition or severe asthma.
10. Women with any contraindication to receiving prostaglandins, including known hypersensitivity to misoprostol or other prostaglandins (PGs) or glaucoma.
11. Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.
Physiotherapy Treatment for Gynecological Cancer Survivors with Urinary Incontinence

The aims of this pilot study are to examine the feasibility and to explore the effects of a physiotherapy treatment compared to standard usual care in gynecological cancer survivors with urinary incontinence in preparation of a large randomized controlled study.

Epidemiological studies demonstrated a growing number of gynecological cancer survivors, and this population is at great risk of developing pelvic floor dysfunction after cancer and its treatment. Representing the most prevalent pelvic floor dysfunction, urinary incontinence affects up to 70% of gynecological cancer survivors. International practice guidelines, in line with available meta-analysis, recommend physiotherapy as a first-line treatment to reduce urinary incontinence. However, there is limited evidence on its effectiveness in gynecological cancer survivors. Considering the current knowledge and the negative impacts of urinary incontinence, there is an urgent need to examine whether this population can benefit from this intervention in a pilot study, to conduct eventually a larger randomized controlled trial. The objectives of the present study are to examine the feasibility and to explore the effects of a physiotherapy treatment compared to standard usual care in gynecological cancer survivors with urinary incontinence. A total of 44 participants will be randomized to receive either physiotherapy or standard usual care (wait-list for physiotherapy). Baseline and post-treatment evaluations will be realized by a physiotherapist.

Eligibility Criteria:
Inclusion Criteria:

* History of gynecological cancer (endometrial, cervical, vaginal or other parts of the uterus)
* Scheduled oncological treatments completed
* Stress or mixed urinary incontinence with a frequency of at least three urinary leakage per

Exclusion Criteria:

* Pelvic floor rehabilitation in the last year
* Other conditions interfering with assessment
Vitamin D and the Influenza Epidemic

Subjects included in ongoing vitamin d intervention trials were asked by questionnaire if they were ill with influenza during the winter season 2009/2010 to see if vitamin d supplementation prevented flu like disease.


Eligibility Criteria:
Inclusion Criteria:

* participant in vitamin D versus placebo study

Exclusion Criteria:

* none
Comparison of Non-nutritive Suck (NNS) Measures to Clinical Estimates of Suck and Feeding Readiness in Preterm Infants

This is a research study to quantitatively assess the development of non-nutritive suck (NNS) and feeding readiness in preterm infants using a novel device, the NTrainer©, and to compare this with two clinical assessment tools, NOMAS and EFS.

Fifteen minutes before feeding, the mobile NTrainer recording station will be positioned cribside. Following a brief exam of physiologic state, using the Oral Feeding Readiness Assessment portion of the EFS, the infant will be cradled in a supportive inclined posture, swaddled, with limbs positioned at midline, and background/overhead lighting dimmed in the area to promote eye contact with the tester. Sampling of NNS behavior will not be initiated until the infant is in an optimal behavioral state, i.e., drowsy to active alert (state 3 or 4 or 5 as described by the Naturalistic Observation of Newborn Behavior, Newborn Individualized Developmental Care and Assessment Program; NIDCAP). The infant will be presented with the NTrainer pacifier, and several contiguous 30-second blocks of NNS nipple compression data will be sampled using the NeoSuck RT software. The infant will remain connected to the usual NICU monitors at all times for observation of respiration, heartbeat and oxygen saturation.

After the NTrainer data collection is completed, the baby will be fed by his or her nurse or parents as directed in the care plan. If the baby is able to feed by mouth, one of the investigators will observe the feeding, and perform 1) a NOMAS evaluation during the first 2 minutes of the feeding, and 2) an EFS assessment after the feeding is completed.

Infants will be studied in 2 sessions each day beginning at Day 4 to 7 of life, then twice weekly (2 sessions per day, 2 days per week) until hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* Born at 30 to 36 weeks gestation and have no exclusion criteria.

Exclusion Criteria:

* Significant birth defects.
* Breathing difficulties severe enough to require being on a ventilator or nasal CPAP for more than 2 hours after birth.
* Any oxygen requirement at Day 4 of life.
* Any neurologic problems, including seizures or frequent apnea spells.
Growth and Safety Clinical Trial on a New Infant Formula

The aim of this study is to assess age-appropriate growth of healthy infants fed a new infant formula. In this randomized, controlled trial, healthy, term, formula-fed infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants or the new infant formula for term infants for 16 weeks. A reference group of human milk-fed infants will also be enrolled. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. This study allows caregivers to participate completely from the comfort of their own home.


Eligibility Criteria:
Inclusion Criteria:

* Normal term infant (37-42 weeks gestation at birth)
* Infant \<15 (+3) days of age at first study feeding, Birth constitutes day 0
* Infant birth weight of ≥2500 g (5.5 lbs.)
* Healthy Infant
* Caregiver who has previously decided to exclusively feed infant formula or exclusively breastfeed and is willing to continue with current feeding method throughout the study (breastfeeding or formula feeding)
* Caregiver willing to conform to protocol requirements (e.g. measuring, feeding, completion of food intake and tolerance diaries, and reporting of AEs)
* Caregiver willing and able to sign informed consent

Exclusion Criteria:

* Infant born in multiple birth (i.e., twins, triplets, etc.)
* Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)
* Infant with family history (parents or siblings) of confirmed Milk or Soy allergies
* Infant with failure to thrive, fever, any GI tract abnormalities (e.g., short gut, gastroesophageal reflux, etc.), any congenital illness or malformation that may affect infant feeding or normal growth
* Caregiver intent to feed non-study formula or solid food during the study
Effectiveness of Cognitive Behavioral Treatment and Mindfulness Based Stress Reduction (MBSR) for Chronic Low Back Pain

The primary purpose of this study is to determine the effectiveness of two psychological techniques in chronic low back pain patients treated in hospital pain clinics. The techniques are: cognitive behavioral treatment and mindfulness based stress reduction (MBSR). This is a multiple site project in which patients come from 16 different pain clinics throughout Spain. The control group is formed by patients under usual medical treatment at pain clinics. The two intervention groups also receive usual medical treatment at pain clinics plus one psychological therapy treatment. The sample size is 330 subjects.


Eligibility Criteria:
Inclusion Criteria:

* Chronic low back pain and failed back surgery patients
* With or without referred or radiated pain
* Who are between 18 and 70 years of age (inclusive)

Exclusion Criteria:

* Patients with red flags for systemic disease or criteria for surgery
* With intolerable intensity of pain despite 6 weeks or more of non-surgical treatment
* With pain that appears only on walking and disappears with sitting, persists after 6 months of conservative treatment, and is a possible spinal stenosis
* Under psychological or psychiatric treatment
* Unable to fill out the questionnaires
* Have received cognitive behavioral treatment in the past
* Have ongoing work litigation or are in the process of obtaining permanent disability.
Anti-Carbamylated Protein Antibodies in Psoriatic Arthritis

Anti-carbamylated protein (anti-CarP) antibodies are present in approximately one-fourth of the patients who are seronegative for both rheumatoid factor and anti-citrullinated protein antibody and who may therefore have psoriatic arthritis. The investigators hypothesized that detection of anti-CarP antibodies in serum may be useful for diagnosis of psoriatic arthritis.


Eligibility Criteria:
Inclusion Criteria:

* "Controls" : Patients with a psoriasis confirmed by a dermatologist and with absence of psoriatic arthritis confirmed by a rheumatologist.
* "Cases" : Patients with psoriatic arthritis fulfilling the classification criteria for psoriatic arthritis (CASPAR), with a diagnosis confirmed by a rheumatologist and associated with personal or familial psoriasis.

Exclusion Criteria:

* "Controls": Presence of any chronic rheumatic inflammatory disease such as psoriatic arthritis.
A Caregiver-mediated Intervention Improves the Functional Ability of Home-living Chronic Stroke Patients

To examine the feasibility of improving stroke patients' physical functional recovery and social participation through improving caregiver's care capability.

In the hospital, most rehabilitation units are like sheltered workshops and the therapists work with stroke patients in well-designed, but non-home-like, environment to improve the stroke patient's functional ability. After returning home, stroke patients face new challenges and also need to assume more responsibility for daily activities. Without continuing rehabilitation training or proper support, the patients can easily fall into a sedentary lifestyle and lead to declines in functional ability.However, providing home-based exercise by therapists directly would increase the health care cost and may not be practical for chronic stroke patients. Hence, the objective of the present study was to determine whether a caregiver-mediated, home-based intervention program is effective for improving stroke patients' functional ability and social participation.

Eligibility Criteria:
Inclusion Criteria:

1. \>6 months post first stroke with mild to moderate disability (Brunnstrom stage III-V)
2. No longer undertaking active rehabilitation program(defined as ≤2 times/wk rehabilitation activities)

Exclusion Criteria:

1. Recurring strokes
2. Mental or cognitive impairment
3. Severe orthopedic disability or unstable medical conditions (such as severe rheumatoid arthritis or acute myocardial infarction)
4. Caregiver with mental/behavioral disorders
PORTAL: Patient-reported Outcomes After Routine Treatment of Atypical Lesions

This research study is evaluating how patients feel physically and emotionally after a prior breast biopsy for specific breast conditions (including atypical lesions such as atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), lobular carcinoma in situ (LCIS), and/or ductal carcinoma in situ (DCIS))

The goal of this research is to better understand the experience of women who have been diagnosed with certain breast conditions to enable women (and their doctors) to make informed decisions about their care.

Eligibility Criteria:
Inclusion Criteria:

Patients treated at DUMC, DFCI, MDACC, MGH, NWH, or DFCI @ SSH with a diagnosis of DCIS, LCIS, ADH, or ALH who are also:

* Age 18 or more at index diagnosis
* Diagnosed with DCIS, LCIS, ADH, or ALH between January 1, 2012 and June 30, 2017
* Able to read either English or Spanish and able to provide written (via paper), or on-line informed consent
* Treated and followed at one of the study sites (including affiliated network sites) and for whom treatment and surveillance data are available, for at least 1 year of follow up after date of diagnosis
* Participants with bilateral synchronous or metachronous disease (DCIS, LCIS, ADH, ALH) are eligible

Exclusion Criteria:

* Ever had a diagnosis of invasive or microinvasive breast cancer
* DCIS prior to index lesion or history of progressive/recurrent DCIS after treatment
* Other cancers (excluding non-melanoma skin cancer) diagnosed within 5 years prior to index lesion, including concurrent invasive cancer diagnosis and up to the present time of participant's approach to invitation into the study
* Patients identified by treating physician as being unsuitable for contact
Experimental Tobacco Marketplace in Regulating Flavored Tobacco Products in Menthol Cigarette Smokers

This trial uses an Experimental Tobacco Marketplace to study the purchase of tobacco products in menthol cigarette smokers. Determining the level of substitutability of both flavored and unflavored/tobacco flavored e-cigarettes when menthol cigarettes are available and unavailable can help determine if a flavor ban (of either menthol cigarettes and/or flavored e-cigarettes) will lead to smoking cessation and/or harm reduction. A greater understanding of tobacco product purchasing could help inform possible regulatory actions by the Food and Drug Administration.

Participants view and purchase hypothetical tobacco products during four distinctly different Experimental Tobacco Marketplace (ETM) conditions. During the session, participants are presented with these randomly ordered conditions: menthol cigarettes and five flavored e-cigarettes (menthol/mint, fruits, sweets, alcohol, snacks/meals), menthol cigarettes and both unflavored and tobacco-flavored e-cigarettes, non-menthol cigarettes and five flavored e-cigarettes, and non-menthol cigarettes and both unflavored and tobacco-flavored e-cigarettes. Participants' visual attention is evaluated by eye-tracking equipment.

Eligibility Criteria:
Inclusion Criteria:

* Menthol cigarette smokers who report smoking a brand that has a non-menthol equivalent.
* Residing in Western New York.
* Voluntarily provide informed consent to participate in the study.

Exclusion Criteria:

* Any known history of macular degeneration, glaucoma, cataracts, eye implant, permanently dilated pupils or the use of a screen reader/magnifier.
* The following special populations will not be included:

  * Adults unable to consent
  * Individuals who are not yet adults (infants, children, teenagers)
  * Prisoners
  * Pregnant women
Management and Clinical Outcome of Neonatal Arrhythmias

assess the Management and clinical outcome of neonatal arrhythmia

Cardiac arrhythmia is a significant cardiovascular disorder in the neonatal period and can result in infant mortality if not diagnosed or treated promptly. The incidence of arrhythmia is about 0.1% to 4.8% during the neonatal period. In neonatal intensive care units (NICUs), the incidence of cardiac arrhythmia could reach 10%. Approximately 1% to 3% of fetal

* cardiac arrhythmias were detected during pregnancy The clinical presentation of NA is variable. Some neonates do not become symptomatic, and could not be diagnosed during
* neonatal period, whereas others may develop signs of congestive heart failure and cardiogenic shock even before birth The most common significant arrhythmia is supraventricular tachycardia (SVT), but atrial flutter (AFL), various forms of atrioventricular block (AVB), and ventricular tachycardia (VT) may also occur. Because of the immature physiology of
* the fetal and neonatal myocardium, heart failure may occur at either abnormally low or high ventricular rates

  * The electrocardiogram (ECG) is the gold standard for identifying problems with heart rate and regularity. However investigations of arrhythmias were hampered by their transitory nature. Monitoring rhythm patterns over extended duration makes Holter monitors a very helpful complementary noninvasive tool in the diagnosis of cardiac arrhythmias. It allows the cumulative evaluation of heart rhythm and rhythm variability, which is important in diagnosing silent and episodic
* arrhythmias in high-risk groups Medical management of SVT consists of a trial of vagal maneuvers, adenosine, and medications to maintain sinus rhythm such as beta blockers and class I or class III antiarrhythmic medications. For neonates who have hemodynamically

  * significant SVT, frequent SVT requiring medical management, pre-excitation on ECG, or congenital cardiac defect chronic medical treatment is appropriate. AF is common in newborns, usually in structurally normal hearts, and long term medical therapy besides initial conversion to sinus rhythm is usually not needed, given the low probability of recurrence
* the prognosis depends on the early recognition and proper management of the condition in some serious neonatal cases Precise diagnosis with risk stratification of patients with non-benign neonatal arrhythmia is needed to reduce morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Neonates up to 28 day with arrhythmia except premature atrial contraction.

Exclusion Criteria:

* More than 28 day
* Neonates with other diseases other than arrhythmia .