cyrilzakka/clinical-trials huggingface dataset:
Bhaktapur Maternal and Child Micronutrient Study

Between February 2008 and February 2009, 500 infant-mother pairs in Bhaktapur, Nepal were randomly selected in this nutritional survey. The dietary intake, nutritional status of several nutrients, growth, and breastfeeding habits were measured in both the women and their infants.The objective of this first phase was to estimate the intake and status of several nutrients in relation to breastfeeding. These mother-child pairs were revisited around the child's fifth birthday when growth, diet, and neurodevelopment was measured. The objective of this phase was to create a cohort study where factors in infancy could be related with health outcomes and development 5 years later.

Over a period of one year, a total of 500 lactating (encompassing both exclusive and partial breastfeeding) women were enrolled in the study and completed the first 24-hour dietary recall. The women attended a hospital for physical examination, dietary interview, and blood sampling. Blood samples were also collected from their infants who also went through a detailed clinical examination

The blood samples from mothers and infant pairs were collected approximately one week apart. The blood was spun down, plasma separated and transferred into storage vials immediately. Plasma and blood pellets were stored in cryovials at -70 until analysis.

All women were also requested to provide one breast milk and one urine sample.

Plasma, blood pellet, urine, and breast milk was stored at -70 degrees celcius until analysis.

Plasma was analyzed for iron, transferrin receptor, ferritin, cobalamin, folate, vitamin A, vitamin D, vitamin E, several amino acids and other micronutrient related metabolites.

The breast milk will be analyzed for iodine, fatty acids, and several B vitamins

The urine was analyzed for iodine.

In phase 2, after 5 years we revisited the mother-child pairs and measured growth, diet, food security, and neurodevelopment.

Eligibility Criteria:
Inclusion Criteria:

* availability of consent
* no ongoing illness
* resides in the selected cluster
* that household information could be obtained
* that the mother was lactating

Exclusion Criteria:

* refused blood sampling
* chronic illness
Effect of Non Invasive Ventilation on Lung Volumes Determined by Electrical Impedance Tomography

Effect of Non Invasive Ventilation on end-expiratory lung volumes determined by electrical impedance tomography

Prospective clinical study in ICU with patients requiring non invasive ventilation (NIV) comparing lung volumes determined by electrical impedance tomography before, during and after NIV.

Duration of NIV is 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Adult ICU patients requiring non invasive ventilation
* Consent of patients or family
* Arterial line

Exclusion Criteria:

* Tracheotomized patients
* Dressings in the thoracic area
Preop Dexmedetomidine Attenuates Haemodynamic Responses to Hydrodissection

Percutaneous tunnelling (hydrodissection) in the neck and anterior chest in patients undergoing robotic thyroidectomy leads to significant haemodynamic responses such as increases in blood pressure and heart rate. The investigators evaluated whether a single preoperative dexmedetomidine injection attenuated the haemodynamic responses to hydrodissection by reducing the half-maximal effective concentration (EC50) of remifentanil needed to maintain haemodynamic stability during hydrodissection.

Dexmedetomidine (DXM) is a recently released and approved alpha 2 agonist with a relatively high ratio of α2/α1-activity and an almost fourfold shorter half-life than clonidine.It's sympatholytic, sedative, and analgesic properties makes DXM a useful anaesthetic adjuvant for general anaesthesia. While there are some reports of the beneficial effects of DXM on anaesthetic requirements and haemodynamic responses to endotracheal intubation, the effect of a single preoperative injection of DXM in terms of attenuating haemodymanic responses to surgical stimulation in robot-assisted thyroidectomy is unknown.

When a robotic thyroidectomy using the bilateral axillary breast approach (BABA) technique is performed, subcutaneous tunnelling in the neck and anterior chest, which is defined as hydrodissection, is mandatory. Unfortunately, the procedure leads to significant haemodynamic responses, such as increases in blood pressure and heart rate.

We hypothesised that preoperative DXM administration would attenuate the haemodynamic responses to hydrodissection. This study was designed to evaluate the effects of a single preoperative administration of DXM on haemodynamic responses to hydrodissection in robotic thyroidectomy by comparing the half-maximal effective concentration (EC50) of remifentanil needed to maintain haemodynamic stability during hydrodissection between DXM and control groups. We also investigated the effects of preoperative DXM administration on total doses of remifentanil and propofol administered intraoperatively.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II patientsscheduled for general anaesthesia for robotic thyroidectomy

Exclusion Criteria:

* Patients with an allergy to α2-adrenergic agonists or propofol
* Patients with current antihypertensive medication
* Patients with heart block \> 1 degree
* Patients with severe cardiorespiratory dysfunction
* Patients with history of alcohol or drug abuse
* Patients who had received an opioid analgesic medication within the previous 24-h period before the operation
Dermatologic Manifestations of Zika Virus

The purpose of this study is to determine whether any diagnostic patterns exist in the symptom presentation of Zika Virus.

The study has both retrospective and prospective components. The retrospective review includes medical records with laboratory confirmed Zika Virus diagnosis and the prospective component will enroll adults presenting with febrile illness and rash and ask them to complete a survey about their symptoms. Diagnostic testing will be completed to confirm infection source.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years and older presenting with febrile illness and rash

Exclusion Criteria:

* Patients aged 17 years or younger
A Multi-site Trial Comparing Lichtensteins Operation and Prolene Hernia System in Inguinal HErnia Repair

Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation or Prolene Hernia System to repair their groin hernia. Follow up for three years with a total number of 4 clinical examinations. End point is postoperative pain and recurrences.


Eligibility Criteria:
Inclusion Criteria:

* Primary unilateral groin hernia in adult

Exclusion Criteria:

* recurrence warfarin treatment bilateral groin hernia
Predicting Exacerbation of COPD With Wireless Telemonitoring

This is an open-label single-center 6-month prospective clinical trial predicting exacerbation of COPD with wireless telemonitoring of respiratory rate, heart rate and sleep in patients admitted to the pulmonary ward of the Turku University Hospital due to acute exacerbation of COPD.

A bed sensor based on ballistocardiogram (BCG) will be used to wireless telemonitoring of respiratory rate, heart rate and sleep for six months after an acute exacerbation of COPD.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients treated due to acute exacerbation of COPD at the pulmonary wards of the Turku University Hospital

Exclusion Criteria:

* Those sleeping with a bed partner and not having separate mattresses
* Patients with pacemaker
Computerized Decision Support Tool for Pain Management in Primary Care

Chronic pain is highly prevalent, compromises quality of life, and increases care utilization. Primary care providers are challenged to provide effective treatments, use opioid therapy appropriately, and address the adverse consequences of pain. Technology-enabled decision support tools may provide a means to improve pain management in primary care.

The objective of this study was to evaluate a novel electronic health record (EHR)-based decision support tool-plus-education intervention for pain management in primary care.

This randomized, wait-list controlled trial evaluated a novel EHR-based system for pain management among patients with chronic pain in six practices of a Federally Qualified Health Center network in New York.

Eligibility Criteria:
Inclusion Criteria:

1. Treated at the Institute for Family Health
2. Spoke English or Spanish
3. Received one or more prescriptions for an opioid or nonopioid analgesic during the past three months
4. Pain screening at the prior three office visits documented scores \>3 on the 0-6 scale (FACES, Hicks et al., 2001).
5. Willingness to complete questionnaires three times
6. A commitment to return to the practice
7. Reachable by phone
8. No evidence of psychopathology or cognitive impairment severe enough to prevent informed consent or completing the survey instruments

Exclusion Criteria:

-
Anti-Inflammatory Dietary Intervention for Rheumatoid Arthritis

The primary objective of this study is to assess if there is a significant difference in the mean disease activity score in individuals with RA participating in a dietary intervention compared to those in the control group measured by DAS-28. Other measures to track disease activity will include monitoring number and severity of disease flares and any changes in medications. This will be done by completing a single-blinded randomized controlled trial, parallel in design. The study population will consist of adults diagnosed with Seropositive and Seronegative RA based on the American College of Rheumatology criteria. Participants will have low, moderate, or high disease activity based on DAS-28 where the investigator feels that they can see improvement from a dietary intervention.

Per the Schedule of Assessments, upon enrollment, participants will be required to come in for a total of five on site visits. The first visit, also known as the baseline visit, will require participants to provided informed consent after all eligibility criteria is met. Subsequently, participants' Demographics, Medical History, EULAR/ACR classification, and physicians' assessments will be documented. Participants' vital signs will be checked and a thorough physical exam will also be performed after which safety labs will be drawn in addition to a routine urinalysis. Participants will complete outcome surveys and a food frequency questionnaire. Participants' body composition will be measured. Concomitant medications will be reviewed. Each participant will receive nutrition education from an approved MD or a consultation with an approved RD depending on the group to which they have been randomized. Participants who receive consultations with an RD will have seven follow up visits after the baseline visit.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years.
* Diagnosed RA by a rheumatologist determined by the 2010 ACR/EULAR Classification Criteria.
* Low, moderate, or highly active disease state based on clinical assessment where the investigator feels there is potential to see a difference.
* Able to read and write in English.

Exclusion Criteria:

* Younger than 18 years.
* Unable to attend the 8 weekly nutrition appointment.
* History of documented eating disorders.
Assessment of Esophageal Epithelium Integrity With Use of a Novel Mucosal Impedance Device

The objective of this study is to design and use a novel, minimally invasive mucosal impedance (MI) technology to inexpensively and accurately test mucosal health in suspected gastroesophageal reflux disease (GERD) and nonerosive reflux disease (NERD) patients as compared to those without GERD.

During routine esophagogastroduodenoscopy (EGD), consented study participants will have the original single channel MI catheter advanced through the working channel of the endoscope. Measurements will be taken at 3 locations for 5 seconds each. The catheter will then be removed and a custom-designed balloon assembly will be inserted through the working channel of the endoscope. The balloon assembly will expand to a maximum diameter of 2 cm spanning from the distal to mid esophagus and contain external metal contacts to form 40 impedance channels made up by 10 axial channels spanning a 10 cm axial area and four radial channels.This design will allow us to measure mucosal impedance both axially and radially thus enabling us to assess the discriminating ability of the device for reflux disease. The balloon assembly will be held in place for 5 seconds. Once the mucosal impedance data have been recorded, the balloon assembly will be deflated and removed by the investigator. The study procedure will add approximately 1-3 minutes of procedure time for each research participant.

Those participants who are diagnosed with Grade C or D esophagitis at the initial visit will return for a follow-up visit after treatment with proton pump inhibitor (PPI) therapy to determine whether or not esophagitis has healed as part of their standard of care. If no esophagitis is detected at the follow-up EGD, we will gather one final comparison MI reading during this visit. If esophagitis is still present, follow-up MI will not be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are undergoing standard of care EGD with or without BRAVO pH capsule placement

Exclusion Criteria:

* Age less than 18 years old
* Patients unable to give informed consent
* Use of acid suppressive therapy within last 10 days
* Known history of Barrett's esophagus or gastric surgery, other than non-functioning (slipped) Nissen fundoplication
Gut Microbiome and p-Inulin in Hemodialysis

The Microbiome trial is a non-randomized, open-label, sequential, multi-center study of p-inulin for patients with hemodialysis-dependent end-stage renal disease.

This primary objective of this exploratory study is to characterize the safety and tolerability of p-inulin (Prebiotin®, provided by JGI Medical) in altering the composition and function of the human gut microbiome, thereby reducing the generation of gut-derived uremic toxins, improving gut barrier function and attenuating systemic inflammation in patients treated with maintenance hemodialysis. The study also aims to assess the feasibility of conducting a full-scale trial of p-inulin. The primary efficacy parameters of the trial will be intra- and inter-participant variability in gut metabolites and bacterial composition. Secondary parameters of interest include tolerability and safety of p-inulin, willingness of hemodialysis patients to enroll in a study requiring repeated collection of stool samples, and participant adherence to agent treatment and specimen collection schedules.

Eligibility Criteria:
Inclusion Criteria:

* Maintenance hemodialysis therapy for end-stage renal disease
* At least 18 years of age
* At least 90 days since hemodialysis initiation
* Self-reported average stool frequency of at least 1 every other day
* For women of childbearing potential, willingness to use a highly effective method of birth control for up to 4 weeks after the last dose of p-inulin.
* Ability to provide consent

Exclusion Criteria:

* Use of prebiotics or probiotics during the past 8 weeks
* Consumption of probiotic yogurt during the past 2 weeks
* Use of antibiotics within the past 8 weeks
* Presence of HIV infection, chronic wound infection, osteomyelitis, or current hemodialysis
* Inflammatory bowel disease, chronic diarrhea, current C. difficile infection
* Cirrhosis or chronic active hepatitis
* Anticipated kidney transplantation, change to peritoneal dialysis, or transfer to another dialysis unit within 9 months
* Expected survival less than 9 months
* Pregnancy, anticipated pregnancy, or breastfeeding
* Incarceration
* Participation in another intervention study
* Severe anemia defined as hemoglobin \<9.0 g/dl within the past 4 weeks as documented in the dialysis unit patient record
Sudden Sensorineural Hearing Loss in Wonju Severance Christian Hospital

This study is to build a cohort of sudden sensorineural hearing loss (SSNHL) patients. When the patient visited the Department of otolaryngology clinic for hearing loss, we can diagnose the SSNHL following the result of pure tone audiometry and the history of the patient. The cohort is a system that tracks the hearing recovery status, timing, and degree of recovery of patients who received cocktail therapy with or without high-dose steroids, vasodilators, antiviral agents, and intratympanic steroid injections, satellite ganglion block, and hyperbaric oxygen therapy.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients over 20 years of age
* A patient who visited Wonju Severance Christian Hospital, Department of Otolaryngology and was diagnosed with sudden hearing loss as it was confirmed that hearing loss of 30dBHL or more occurred within 3 days at three consecutive frequencies in a pure tone audiometry test.
* Those who have fully explained the purpose and content of the study and voluntarily agreed to the written consent

Exclusion Criteria:

* If the patients do not want to or do not fill out the consent form
* If treatment is started for sudden hearing loss, but the possibility of other inner ear diseases including Meniere's disease is suspected due to repeated hearing loss, repeated recovery, dizziness, tinnitus, etc.
* Other cases where it is judged difficult to carry out the clinical trial due to the judgment of the person in charge of the above clinical trial
A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients

To characterize the safety and efficacy of fixed doses of MDL 28,574A administered alone and in combination with zidovudine ( AZT ) in patients with asymptomatic or mildly symptomatic HIV infection. To examine the demographic effects on population pharmacokinetics and pharmacodynamics of MDL 28,574A alone and in combination with AZT.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Prior antiretroviral agents for up to 6 months per agent.

Patients must have:

* HIV infection.
* Asymptomatic or mildly symptomatic.
* CD4 count 301 - 500 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Patients with the following condition are excluded:

Unable or unwilling to comply with study procedures.

Concurrent Medication:

Excluded:

* Chemoprophylactic therapy for mycobacterial infection.
* Any nonstudy prescription medications without approval of investigator.

Patients with the following prior conditions are excluded:

* History of grade 3 or 4 toxicity to \<= 600 mg/day AZT.
* History of intolerance to lactose.
* Chronic diarrhea within 6 months prior to study entry.
* Unexplained intermittent or chronic fever, defined as temperature \>= 38.5 C for any 7 days within the 30 days prior to study entry.

Prior Medication:

Excluded:

* Antiretroviral therapy within 2 weeks prior to study entry.
* Prior HIV vaccines.
* Biological response modifiers within 30 days prior to study entry.
* Prior foscarnet.
* Any investigational drug with a washout \< 5 half-lives prior to study entry.
* Any medications known to alter renal, hepatic, or hematologic / immunologic function (such as barbiturates, phenothiazines, cimetidine, immunomodulators, etc.) within 14 days prior to study entry.

Recent history of alcohol and/or drug abuse.
Undiagnosed Hepatitis C Infection in an Urban Hospital

The Centers for Disease Control and Prevention estimates that there are approximately 3.2 million people in the United States infected with hepatitis C and a significant percentage of these patients are unaware of their diagnosis. This study will attempt to determine the point prevalence of undiagnosed hepatitis C infection in an urban hospital population. All patients admitted to the hospital on two separate days will have hepatitis C testing done on leftover serum and plasma that was collected as part of routine inpatient lab work. Our primary goal is to determine the number of undiagnosed hepatitis C infected patients in our hospitalized population. We will also compare these rates to specific demographic characteristics, such as age, race, gender, zip code and type of insurance to see if any associations exist between these demographics and undiagnosed hepatitis C infection.

De-identified study of Hepatitis C infection point prevalence in the inpatient setting of an inner city hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to Temple University Hospital on either of the study dates

Exclusion Criteria:

* Patients admitted on both study dates will only be counted once
The Spine Kinematics and Center of Pressure Excursion During Functional Task Vertebral Compression Fractures Subjects

This study aimed to assess the sensory and kinematic components of the limits of stability (LOS) test in patients with vertebral compression fracture (VCF) .

This study enrolled adults with VCF (VCF group), older adult without spinal deformity (NE group), and young adults (NY group). The Biodex balance system was employed to calculate the balance score and the LOS of participants. An inertia motion system was used to record kinematic data. The center of pressure (COP) signals of postural stability and LOS were used to calculate the frequency power spectrum for interpreting the sensory component.

Eligibility Criteria:
Vertebral compression fracture Inclusion Criteria:

older than 65 years osteoporosis diagnosed by a bone mineral density test of the lumbar spine (T-score \< -2.5; T: peak bone mass) thoracic-lumbar VCF on radiography without displacement

Vertebral compression fracture Exclusion Criteria:

other spinal diseases that might also cause back pain (such as scoliosis, lumbar spondylolisthesis, lumbar disk disease, and spinal stenosis) a history of diabetes a history of neurological disease (such as cerebral vascular disease, peripheral neuropathy and vestibular disease).

Control Inclusion Criteria:

None the control participants had evidence of gait, postural, or spine disorders.
Vitamin D Supplementation and TB

The goal of this study is to understand the effects of vitamin D supplementation on immunological outcomes among patients with tuberculosis.

In this randomized trial, the investigators will enroll 200 adults with active pulmonary tuberculosis (TB; among whom 40 have HIV co-infections) at the time of TB diagnosis in S India. The intervention will include daily vitamin D supplementation in 3 treatment arms (600, 2000, and 4000 IU vitamin D), compared to placebo, for 12 months. The investigators' primary objectives are to assess how vitamin D supplementation affects immunity (immunological markers, immune competence) and serum vitamin D levels. Secondary outcomes include TB treatment outcomes (successful sputum smear conversion, relapse) in all patients, and human immunodeficiency virus (HIV) disease progression among a subset of patients with HIV co-infection.

Eligibility Criteria:
Inclusion Criteria:

* Active TB diagnosis by GeneXpert
* HIV infection status (according to AMC HIV clinic medical records of enzyme-linked immunosorbent assay \[ELISA\] results)

Exclusion Criteria:

* Children (\<18 years of age)
* 60 years of age
* Pregnant at baseline
* Other severe complications or illnesses requiring hospitalization
* Received TB treatment for greater than 4 weeks in the past 5 years
* Refused to participate
* Residing in a geographic location \> 1 hour from AMC (by public transit)
Evaluation of Pre-deployment Device-to-artery Relative Axial Motion in Coronary Catheterizations

The cyclic movement of the heart and the coronary arteries induces relative axial movement between the artery and a pre-deployed intra-luminal stent which may cause malpositioning. Using a new imaging algorithm to indicate the position of a stent in patients undergoing percutaneous coronary intervention (PCI), the investigators will measure the pre-deployment relative, intra-luminal stent axial movement in the different coronary arteries to facilitate the precise deployment site.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing routine PCI

Exclusion Criteria:

* Unstable patients