cyrilzakka/clinical-trials huggingface dataset:
Silo Versus Primary Closure for Gastroschisis

The objective of this study is to scientifically evaluate two different closure strategies for gastroschisis to determine if there is a difference in the two approaches.

The hypothesis is that there is no difference between bedside silo placement and operative closure in return of bowel function, ventilator dependence, or length of stay.

The primary outcome variable between the two techniques will be length of hospitalization. The likely variables will be length of time to meet discharge criteria, length of hospitalization, time to full feedings, time on mechanical ventilation and total hospital charges.

Eligibility Criteria:
Inclusion Criteria:

* Infants with gastroschisis

Exclusion Criteria:

* Born prior to 34 weeks estimated gestational age
* Another congenital anomaly influencing the respiratory status, gastrointestinal status, or the length of hospitalization and recovery.
* Inability to get parental permission before treatment.
Integrating Enhanced HIV PrEP Into a STI Clinic in Lilongwe

This is a prospective cohort study evaluating acceptability, feasibility, and effectiveness of integrating HIV pre-exposure prophylaxis (PrEP) into a sexually transmitted infection (STI) clinic alongside assisted partner notification and etiologic STI testing in Lilongwe, Malawi.


Eligibility Criteria:
Patient Participant

Inclusion Criteria:

* ≥15 years of age.
* Eligible for PrEP according to Malawi PrEP guidelines (see below)
* Presenting for care at STI clinic (primary presentation or referral from partner based on STI or HIV exposure)
* Able to consent for study participation and willing to provide locator information for follow-up tracing

  \*Malawi PrEP eligibility criteria:
* Age ≥15 years
* HIV seronegative iii. At substantial risk for HIV, with prioritization of persons who:
* Buy or sell sex; Key population (female sex worker, men who have sex with other men, transgendered persons; Vulnerable population included adolescent girls and young women aged 15-24; STI clients; Serodiscordant couples including HIV-negative women who are pregnant or breast feeding or HIV-negative men or women for whom their HIV-infected partner is: not on ART, on ART \<6 months, has an unsuppressed or high viral load, or is non-adherent to ART, iv. Have ruled out acute HIV infection, or defer PrEP initiation for anyone with signs or symptoms consistent with acute HIV infection, v. Willingness to attend scheduled PrEP visits, vi. No contraindication to use of TDF and 3TC, vii. Bodyweight ≥30 kg, viii. Estimated glomerular filtration rate (eGFR) ≥60mL/min, ix. No known renal diseases, x. No diabetes mellitus.

Exclusion Criteria:

* Current imprisonment or incarceration in a medical or psychiatric facility

Provider Participant:

Inclusion Criteria:

* ≥18 years of age.
* Duties relevant to integration or provision of PrEP and/or aPN at STI clinic

Exclusion Criteria:

- Unable or unwilling to provide informed consent
Positive Parenting: Empowering Young Mothers Experiencing Homelessness With a History of Inter-personal Violence to Improve Parenting Strategies

The purpose of this study is to strengthen the skills and self-efficacy of women by addressing the social and emotional trauma that they have experienced from inter-personal violence (IPRV) and homelessness and to promote positive parenting strategies through Play and Learning Strategies (ePALS), an evidence based intervention.


Eligibility Criteria:
Inclusion Criteria:

* women's report of physical, sexual or psychological abuse from a partner/ family member/ acquaintance/ stranger within the last 24 months
* have at least one child under the age of 5 years old

Exclusion Criteria:

* non-English speaking
* physical presence of a male partner at the time of enrollment
Longitudinal Study of Cortisol and Pulmonary Function

To conduct a longitudinal study of the relationship between the rate of decline of pulmonary function and measurements of cortisol concentration and excretion in a sample of middle-aged and older men and their wives. The study tested the hypothesis that persons whose plasma cortisol concentrations were relatively low, albeit within the normal range, were predisposed to excessively rapid deterioration of pulmonary function during aging.

BACKGROUND:

It was hoped that the study would provide important insights into the pathogenesis of chronic obstructive pulmonary disease with potential implications for prevention and early therapeutic intervention.

DESIGN NARRATIVE:

All subjects participating in the Normative Aging Study were recruited for the study at the time of their next scheduled examination. Twenty-four hour urinary excretion of free cortisol, morning serum cortisol concentration, and pre- and post-bronchodilator spirometric indices were measured. For the 700 subjects who were recruited during years one and two of the study, these measurements were repeated when subjects returned for their next triennial examination in years four and five of the study. Respiratory illness and smoking questionnaire data, total and differential leukocyte counts, and methacholine inhalation challenge test data were also available at both time points. The specific aims of the study were to examine: (1) the cross-sectional relationship between level of pulmonary function and both morning serum cortisol concentration and 24-hour urinary free cortisol excretion; (2) the relationship between the rate of decline of pulmonary function during the follow-up interval and these measurements of cortisol concentration and excretion; (3) whether these relationships were modified by smoking history, blood total leukocyte count, methacholine airway responsiveness, or other characteristics; and (4) the stability over time of serum cortisol concentration and urinary cortisol excretion in this aging population.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Comparison of Airway Intubation Devices When Using a Biohazard Suit

We will investigate the impact biohazard gear has on time to successful intubation and, in particular, determine how the Supraglottic Airway Laryngopharyngeal Tube (Ecolab, Columbus, Missouri) device compares to traditional direct laryngoscopy and fiber-optic (video) intubation techniques.

This study will take place in an academic/training facility at Lehigh Valley Health Network simulating intubation during a bio-terrorism attack. As a part of their usual (standard of care) residency education, the study volunteers will be participating in a day-long airway training course in the Fall of 2013 where each of the tested devices will be introduced and the residents will be able to practice using them on a variety of training mannequins.

As part of this training, the enrolled study subjects will be timed using each of three intubation devices, both with and without wearing biohazard protective gear, for a total of six measurements per resident. Residents will have been assigned chronological numbers as they arrived and signed in for the course. These numbers will be also used for study identification numbers. Subjects will be randomized by odd or even identification numbers as to whether they will make their initial attempt in street clothing or the biohazard suit. This will help control for individual subject's skill learning. The subject will then intubate the same mannequins using each of the tested devices.

The order of devices used will be the same as in actual clinical practice: 1) Direct Laryngoscopy (the classic standard of care), 2) the GlideScope or C-MAC video laryngoscope (fiber-optic technology, which has become increasingly popular among emergency physicians), and 3) the Supraglottic Airway Laryngopharyngeal Tube airway device (an inexpensive, convenient supraglottic device that allows for a blind intubation technique through the device).

Data will be collected, per device, on the time taken and tubes used for each attempt. Demographic information will also be collected from participants such as gender, resident year, prior intubation experience, prior exposure to each of the tested devices, and experience wearing a biohazard suit. Study participants' satisfaction with each of the devices will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Emergency Medicine residents who volunteer to participate and allow their data to be used for research purposes

Exclusion Criteria:

* Not an Emergency resident who volunteers to participate and allow their data to be used for research purposes
Physical and Psychological Profiles Associated With Patient's Preference for ESRD Treatment

Highlighting the relationship between psychological and physical profiles and patient's preference to better understand the patient's treatment preference and improve the information provided.

CKD is a Public Health Problem with a prevalence of 10% in general population. For patients reaching The making decision to treat ESRD with renal replacement therapy is a complex process and needs to be shared between patients, family, physician and nephrologist.

Systematic Information delivery about several treatments of ESRD is recommended for patients and his family (Hemodialysis, Peritoneal Dialysis, Kidney Transplantation and Conservative treatment). Some studies on the preference of patients for renal replacement therapy reported a choice for PD about 50% while the registers report a low diffusion of PD (around 10%). Since 2009 we propose a systematic information about the different therapeutic options for ESRD and identified some clinical characteristics associated to patient's preference. However we want to know if psychological or physical phenotype is associated to patient's preference.

The objective of the study is to highlight the relationship between psychological and physical profiles and patient's preference to better understand the patient's treatment preference and improve the information provided.

Eligibility Criteria:
Inclusion Criteria:

* More than 18 years
* CKD with estimated GFR below 20 ml/min/1.73m2 without dialysis treatment
* Patient who accepts information delivery about treatments of ESRF
* Patient who accepted and signed the informed consent
* Subject beneficiary of a social security system

Exclusion Criteria:

* Inability to achieve psychological tests
* Inability to achieve physical tests
Locally AblatiVe TherApy in OLigO-pRogressive SOlid TUmorS (VALOROUS)

This is a phase 2 pragmatic study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary outcome measure is the time to treatment failure (defined as time to change in systemic failure or permanent discontinuation of therapy) following locally ablative therapy.

This is a phase 2 pragmatic study at a single site that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary endpoint is disease control at 3 months, defined as continuation in systemic cancer therapy without any changes or permanent discontinuation for 3 months following first day of ablative local therapy. Participants will receive ablative local therapy per standard practices in addition to their systemic therapy and will be followed for up to 5 years following ablative local therapy. Participants will be assigned stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy per the discretion of treating radiation oncologist and/or interventional radiologist.

Eligibility Criteria:
Inclusion Criteria:

1. Must have one of the following histologically and/or biochemically confirmed genitourinary malignancies:

   1. Cohort A: Breast Malignancy
   2. Cohort B: Gynecological Malignancy
   3. Cohort C: Head and Neck Malignancies
   4. Cohort D: Sarcomas
   5. Cohort E: Other solid malignancy specified in the protocol
2. Provision of signed and dated informed consent form.
3. Stated willingness to comply with all study procedures and availability for the duration of the study.
4. Age ≥18 years at time of consent.
5. Currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy.
6. ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. \[Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment\]
7. ≤ 5 progressing or new metastatic lesions.
8. All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and/ interventional radiologist.

Exclusion Criteria:

1. Medical comorbidities precluding locally ablative therapies.
2. History of treatment related toxicities that limit or prohibit application of locally ablative therapies.
3. Progressing intracranial lesions.
Immune Benefits of WGP in Elderly

The aim of this research is to assess the immune enhancing property of food fibers in the elderly population.


Eligibility Criteria:
Inclusion Criteria:

* Male and female elderly volunteers equal or above age of 70
* Pre-frail and frail subjects (based on Fried's criteria)
* Willing to be vaccinated against influenza and having no contraindication to receive influenza vaccination
* Having obtained his/her (or his/her legal representative's) informed consent

Exclusion Criteria:

* Subject with a rapidly deteriorating health status (terminal, severe, or uncontrolled acute/chronic diseases)
* Allergy to eggs or influenza vaccine components.
* Subject who has received any vaccination in the last 3 months or has previously been vaccinated with the current seasonal influenza vaccine.
* Subject who is currently taking, or has taken in the last 4 weeks, or will take immune modulating medication during the study, including steroid, immune suppressive treatment.
* Subject who has taken antibiotics in the last 2 months prior to entering the study.
* Subject who is consuming regularly prebiotic and/or probiotic supplements, yogurts, and/or other dietary supplements.
* Personal or family history of Guillain-Barre syndrome
* BMI\>35 kg/m2
* Subject who has received blood transfusion or had a blood donation during the last 4 weeks prior to the beginning of this study.
* Subject who cannot be expected to comply with the study procedures
* Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
Age Versus Ovarian Reserve Markers Based Therapy in IVF (IVF)/Intracytoplasmic Sperm Injection (ICSI) Cycles

This randomized controlled trial has been designed for carrying out a comparison of new AMH (Anti-Müllerian Hormone)-based individualized treatment (using a nomogram) with the wide accepted age-based strategy. The main objective of the trial is to assess whether an individualized FSH starting dose can increase the rate of women with an adequate ovarian response in terms of retrieved oocytes (optimal number of retrieved oocytes: 8-14).

Before clinicians can adopt any model into routine clinical practice, the accuracy of the model should be independently evaluated in a population different from the one on which the model was elaborated. External validation of the model is therefore crucial to assess the generalizability to other populations.

In the present RCT the new AMH-based individualized treatment will be compared to the wide accepted age-based strategy.

Primary endpoint:

The percentage of women with an appropriate number (n=8-14) of retrieved oocytes in IVF/ICSI cycle.

Secondary endpoints:

1. Serum E2 levels on r-hCG day
2. Serum P levels on r-hCG day
3. Number of growing follicles (≥11mm) on r-hCG day
4. Number of large (≥ 17 mm) ovarian follicles on r-hCG day
5. Total r-FSH dose employed
6. Treatment duration
7. Rate of women with dose adjustment
8. Number of cancelled cycles because of poor and hyper-response
9. Fertilization rate
10. Embryos obtained
11. Implantation rates
12. Biochemical pregnancy rates
13. Clinical pregnancy rates
14. OHSS rates

Eligibility Criteria:
Inclusion Criteria:

* first or second IVF/ICSI attempt (the second one after 6 months from the first one);regular menstrual cycles (25-33 days);female age ≤ 40; day 3 FSH ≤ 15IU/L;treatment with a long GnRH agonist protocol (buserelin)+rFSH;BMI: \>18 and ≤ 25 kg/m2;presence of both ovaries.

Exclusion Criteria:

* irregular cycles, anovulatory infertility, endometriosis III-IV stage AFS, use of adjunctive therapies for stimulation, evidence of PCO status, previous ovarian surgery, presence of ovarian cysts, history of PID, use of hormonal contraception in the previous 3 months, any known metabolic or endocrinological disease, AMH levels \< 1 and \> 4.0 ng/ml
Acupuncture for Pain Management of Hemodialysis Patients

The purpose of this study is to determine the feasibility, effectiveness and safety of acupuncture for pain management in hemodialysis patients.

Pain is one of the most common symptoms experienced by end-stage renal disease (ESRD) patients, which subsequently debilitates patient's quality of life. Although reducing pain is crucial to successful patient care in hemodialysis population, symptoms are often undertreated.Conventional pharmacological approaches are limited in dialysis population , given their altered pharmacokinetics and pharmacodynamic profiles and increased potential for adverse reactions. Acupuncture has been known to be beneficial in various chronic pain condition. As a non-pharmacologic intervention, it might be valuable for pain management in hemodialysis patients whose analgesic use are limited due to altered pharmacokinetics. However, little is known for the benefits of acupuncture for pain management in dialysis population. This study aims to determine whether acupuncture is a feasible, effective and safe therapeutic intervention for pain management in hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* started hemodialysis at least 3 months ago
* receiving hemodialysis 3 times a week regularly
* equilibrated Kt/V ≥ 1.2
* pain occurred at least 3 months ago
* MYMOP2 symptom 1 score ≥ 3
* willingness to participate in this study

Exclusion Criteria:

* acute/chronic liver disease
* events of life-threatening cardiovascular disease within 6 months
* events of life-threatening neurological disorder within 6 months
* current/past history of neoplasm (in past 5 years)
* hemorrhagic disorder
* drug abuse/alcoholism
* other infectious disease
* history of the use of acupuncture, moxibustion or herbs within 1 month
Study of Individuals With Parkinson's Symptoms But in Whom There is Diagnostic Uncertainty

The overall goal of this study is to evaluate the use of dopamine transporter (DAT) imaging as a diagnostic tool in subjects with early parkinsonian symptoms, in whom Parkinson's disease (PD) or parkinsonian syndrome (PS) is suspected, but the diagnosis remains unclear from a clinical standpoint.

* Subjects will be referred to the Institute for Neurodegenerative Disorders (IND) by practicing general neurologists with genuine uncertainty regarding the subject's diagnosis.
* Subjects with suspected PD or PS will be evaluated clinically and with DAT imaging, using b-CIT and SPECT. The DAT imaging procedure will take place over two days:
* On the first day participants are injected with \[123I\]ß CIT, an investigational radioactive material that localizes in the brain. Study participants will also have a thorough neurologic examination and standard neuropsychological testing, including testing of memory, concentration, abstraction and visual spatial functions.
* Twenty-four hours later study participants return to the Institute for Neurodegenerative Disorders where an investigational scanning procedure will be used to obtain SPECT (single photon emission computed tomography) images of the brain.
* Subjects will be asked to return within 3 months following the imaging study to have a repeat neurological examination by the two study neurologists at IND.
* Subjects will be asked to return at about 6 months and possibly again at one year following the imaging study for a final clinical evaluation by one of the study neurologists at IND.

Eligibility Criteria:
Inclusion Criteria:

* Age \>21
* Any parkinsonian or extrapyramidal symptoms
* Parkinsonian symptoms for \< 2 years duration.
* No significant abnormalities on screening laboratory studies including: CBC, Chem-20 and urinalysis.
* Willingness to comply with study protocol.

Exclusion Criteria:

* Pregnancy
* Significant medical disease including abnormalities on screening biochemical or hematological labs or abnormal electrocardiogram (ECG).
Engaging Religious Leaders to Reduce Blood Pressures in Tanzanian Communities

The investigators hypothesize that communities in which religious leaders are provided with education about blood pressure and how to measure blood pressure will have lower overall average blood pressures than communities in which religious leaders do not receive education about blood pressure.

This research is being done to determine whether the Religious Engagement in Health Intervention can reduce community blood pressure. The study is being conducted in the Northwestern Tanzania. 20 communities will be involved: 10 will be randomized to the Religious Engagement in Health Intervention arm, and 10 will be randomized to the control arm. The Religious Engagement in Health Intervention includes the following three evidence-based components: (1) educational sessions for Christian and Muslim leaders on religious teachings and medical aspects of blood pressure, (2) equipping religious leaders to provide blood pressure teaching in their communities using knowledge learned from educational sessions and through longitudinal mentorship meetings, and (3) community blood pressure screening organized by religious leaders in partnership with local health care workers, and referrals for clinical care as needed.

Eligibility Criteria:
Inclusion Criteria:

* Adult ≥35 years of age
* Has lived in the community for ≥1 year
* Household identified for random sampling is primary residence: has slept in the household at least once in the past 2 weeks and considers this their primary residence

Exclusion Criteria:

* First-degree relative from the same household already enrolled
* Relative of the same sex from the same household already enrolled
Perioperative Analgesia by Femoral Perineural Catheter for Femoral Neck Fracture - Study KTcol

Therapeutic essay of phase IV, monocentric, prospective, randomized, in double-blind during 48 hours(then simple-blind),controlled by placebo.

Abstract:

The increasing incidence of the number of femoral neck fractures and the poor prognosis of this traumatological pathology involves an optimization of the diagnostic, therapeutic and analgesic care.

A widespread collectively practice for the analgesia in prehospital or preoperative period is the single injection ("single shot") of local anesthetic with the technique of the femoral or iliofascial block. Nevertheless the single injection of a dose of local anesthetic associated or not with analgesic adjuvants, due to their pharmacological properties, can't prolong the efficiency of the loco-regional analgesia more than 12 hours.

The aim of our study is to evaluate, in the patients admitted in emergencies for suspicion of femoral neck fractures, the perioperative efficiency of an analgesic treatment using a femoral perineural catheter (inserted from the hospital admission) with continuous infusion of ropivacaïne controlled by placebo (physiological serum).


Eligibility Criteria:
Inclusion Criteria:

* femoral neck fracture

Exclusion Criteria:

* Contraindication with analgesia