bioihbjkbjnl/mcl2 huggingface dataset:
Genetic Variants Modulate Association Between Dietary n-3 LCPUFAs and DHA Proportion in Breast Milk
Condition: Fatty Acid Desaturases; Polymorphism, Single Nucleotide; Milk, Human
Study type: Observational

Summary: 
      DHA is important for the development of brain and retina in newborns. Considering that
      exclusive breast feeding for at least 4 ~6 months are globally recommended, plus it is well
      known that nutrient requirement is determined by both genetic and environmental (including
      diet) factors, this clinical study sought to investigate how the DHA levels in maternal milk
      is modulated by genetic variants and dietary n-3 LCPUFA intake. To recruit subjects (n=193),
      the inclusion criteria are Han Chinese women just having delivered full-term baby, 20-40
      years old, healthy, and willing to breast feed their baby for at least 2 months. Written
      informed consent will be obtained from participants. Personal information (or covariates)
      such as height, weight (before getting pregnancy and delivery, respectively), age, parity,
      education, smoking, alcohol drinking, gender of baby…etc, and DNA from oral swab will be
      collected. Breast milk and dietary data will be collected at the end of the 1st and 2nd month
      of postpartum period. Considering Han Chinese women usually have special postpartum diets and
      care during puerperium, therefore, collection of breast milk and dietary information will be
      repeated at the 2nd month. The fatty acid composition in milk will be analyzed by gas
      chromatography. Using food frequency questionnaire, intake of n-3 LCPUFA from foods + fish
      oil supplements will be calculated. Subjects will be instructed to give a 3-days food record
      as well. We foresee results of this study might contribute to public health care as
      nutritionists/dietitians will be able to target the vulnerable subjects, who are dietary
      dependent for DHA, for dedications in nutrition consults or customized dietary guidance.
      Moreover, these information are valuable in making policy regarding dietary recommendation in
      Taiwan.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Of all 193 participants, there were 180 who continued to track for two months.
Myofascial Pain Syndrome and Plantar Fasciitis Treatment
Condition: Plantar Fascitis; Myofascial Pain Syndrome
MeSH terms: Fasciitis; Myofascial Pain Syndromes; Fasciitis, Plantar; Fibromyalgia; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      Patients with plantar fasciitis between the ages of 25-65 years who presented to the Physical
      Medicine and Rehabilitation clinic with the complaint of heel pain and met the inclusion and
      exclusion criteria will be included in the study. Demographic data (age, gender, body mass
      index, symptom duration) will be recorded at the beginning of the study. Then, Foot
      Functional Index (FFI) and Visual Analog Scale (VAS) scales will be recorded. Participants
      will be randomly divided into two groups. Group 1 will receive dry needling and Group 2 will
      receive extracorporeal shock wave therapy (ESWT). Patients in the 1st group will undergo 3
      sessions of dry needling with Seirin branded 0.6*50 mm acupuncture needles at one week
      intervals for the trigger point detected by manual palpation in the medial gastrocnemius,
      lateral gastrocnemius, soleus, flexor digitorum brevis, quadratus plantae, abductor hallucis
      brevis muscles. Patients in the 2nd group, Patients in this group received three sessions of
      ESWT (MASTERPLUS MP 200 ENERGY 2 trademarked ESWT device) at an energy density of 2 bars and
      a frequency of 2,000 shocks/min at 12 Hz for three weeks, each session once a week. Each of
      the five most sensitive and painful points was given 400 pulses in the supine position
    


Intervention name(s): ESWT; Dry needling
Intervention type(s): Device; Procedure
Intervention description(s): Patients in this group received three sessions of ESWT (MASTERPLUS MP 200 ENERGY 2 trademarked ESWT device) at an energy density of 2 bars and a frequency of 2,000 shocks/min at 12 Hz for three weeks, each session once a week. Each of the five most sensitive and painful points was given 400 pulses in the supine position; Dry needling with Seirin branded 0.6*50 mm acupuncture needles will be performed for 3 sessions with one week intervals for the trigger point detected by manual palpation in the medial gastrocnemius, lateral gastrocnemius, soleus, flexor digitorum brevis, quadratus plantae, abductor hallucis brevis muscles of the patients in the group.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly divided into 2 groups and will be treated with ESWT or Dry needling.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: plantar fasciitis; ESWT; dry needling
Randomized Trial for Pharmacogenomics-based Tuberculosis Therapy (RT-PGTT)
Condition: Pulmonary Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to elucidate whether the individualized medicine based on NAT2
      gene polymorphism could improve the safety, efficacy and economical benefits of multi-drug
      therapy for the pulmonary tuberculosis with isoniazid.
    


Intervention name(s): Isoniazid; isoniazed
Intervention type(s): Drug; Drug
Intervention description(s): Modified daily isoniazid dose : approx. 7.5 mg/kg, 5 mg/kg and 2.5 mg/kg for rapid, intermediate and slow acetylators, respectively; Conventional standard daily isoniazid dose : approx. 5 mg/kg b.w. for all
Intervention MeSH terms: Isoniazid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pulmonary tuberculosis; isoniazid; arylamine N-acetyltransferase 2; pharmacogenomics; genetic polymorphisms; individualized medicine; drug-induced hepatotoxity
Pocket Echocardiography System (PES) for Detection of PDA in Neonates
Condition: Patent Ductus Arteriosus
MeSH terms: Ductus Arteriosus, Patent
Study type: Interventional

Summary: 
      This is a single-center, feasibility study involving all neonates admitted to the neonatal
      intensive care unit with orders for a cardiac echo evaluation. Parents will be approached and
      provided a description of the study. No written consent will be requested, but parents have
      the option of opting out. Each patient will have a 5 minute Pocket echocardiography system
      scan followed by a full echo performed on a traditional full featured echo system. The
      objective is to assess if the current Food and Drug administration (FDA) approved Pocket
      echocardiography system (PES) can detect patent ductus arteriosus (PDA) in neonates as
      comparable to traditional full featured echo systems (FFES) and/or physical exam alone.
    

Detailed description: 
      All newborns admitted to the neonatal intensive care unit with orders for a cardiac echo
      evaluation will be included in this study. Parents will be approached and provided a
      description of the study. No written consent will be requested, but parents have the option
      of opting out. If parents agree to be part of this study, a 5-minute PES scan will be
      performed first so as to not bias the sonographer. Then, a full echocardiogram study will be
      performed on a traditional FFES. The scans will be performed at the bedside. The images will
      be reviewed and compared by fellow and/or attending and by experienced sonographer. The scans
      will include short axis view, ductal view and arch view.

      The objective of the study is to assess if the current FDA approved PES can detect PDA in
      neonates as comparable to traditional full featured echo systems and/or physical exam alone.
      Using PES for PDA diagnosis will be an accessible, economic and effective way of
      complementing the findings in our physical exam by increasing diagnostic accuracy, and
      detecting PDA's at the bedside comparable to a full size traditional echocardiographic
      system.
    

Intervention name(s): PES first, then FFES
Intervention type(s): Device
Intervention description(s): A 5-minute Pocket echocardiography system scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
Other intervention name(s): Pocket echocardiography system scan; Full Featured Echocardiography System Scan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: PDA; Echo; PES; Handheld echo system
Formula Tolerance of Term Infants
Condition: Gastro-Intestinal Tolerance
Study type: Interventional

Summary: 
      To assess the effects of infant formula with oligosaccharides on symptoms of formula
      intolerance in healthy, term infants
    


Intervention name(s): Study Infant Formula
Intervention type(s): Other
Intervention description(s): RTF milk-based infant formula with oligosaccharides
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of Peginterferon Alfa-2a in Participants With Chronic Hepatitis B Virus (HBV) in an Expanded Access Program
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an expanded access, multicenter, national, open-label, and non-randomized study to
      analyze the safety of peginterferon alfa-2a in participants with hepatitis B e antigen
      (HBeAg) positive and HBeAg negative chronic HBV infection. All participants will receive 48
      weeks treatment of peginterferon alfa-2a monotherapy, followed by a 24 week treatment-free
      follow-up period.
    


Intervention name(s): Peginterferon alfa-2a
Intervention type(s): Drug
Intervention description(s): 180 mcg SC injection QW for 48 weeks.
Other intervention name(s): Pegasys
Intervention MeSH terms: Peginterferon alfa-2a
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study was to determine if treatment with SAGE-217 reduces
      depressive symptoms in participants with severe postpartum depression (PPD) compared to
      placebo as assessed by the change from baseline in the 17-item Hamilton Rating Scale for
      Depression (HAM-D) total score at Day 15 and to evaluate the safety and tolerability of
      SAGE-217 compared to placebo as assessed by the incidence of adverse events, vital sign
      measurements, clinical laboratory evaluations, electrocardiogram (ECG) parameters, and the
      Columbia Suicide Severity Rating Scale (C-SSRS).
    

Detailed description: 
      This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the
      trial was transferred to Biogen.
    

Intervention name(s): SAGE-217 15/20 mg Oral Solution; Placebo; SAGE 217 30 mg Capsules
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SAGE-217, 15 mg oral solution, BID for Days 1 to 2 followed by 20 mg oral solution BID for Days 3 to 14. If not tolerated, 15 mg for the rest of study (Days 3 to 14).; SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.; SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postpartum Care
Effects of Short Wave Diathermy Added on Dextrose Prolotherapy Injections in Osteoarthritis of the Knee
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Hyperthermia
Study type: Interventional

Summary: 
      Goal: To show the effects of short wave diathermy added on prolotherapy injections in
      osteoarthritis of the knee on pain, physical functioning and quality of life.

      Material and Methods: 63 patients with osteoarthritis of the knee with Kellgren-Lawrence
      (K-L) class 2 or 3 were included in the study. Patients were randomized to two grous, first
      being dextrose prolotherapy+ short wave diathermy(SWD), and second being dextrose
      prolotherapy with sham SWD. Patients were injected with dextrose prolotherapy solutions in
      the beginning, 3rd and 6th week of the study, for a total of 3 times, and took 20 minutes of
      SWD after injection(true or sham). Western Ontorio and McMaster Universities Osteoarthritis
      Index (WOMAC), Visual Analogous Scale for pain(VAS) and Short Form Health Survey (SF-36)were
      applied before, after(6th week) and at the 3rd month of treatment.
    


Intervention name(s): Short wave diathermy; Prolotherapy
Intervention type(s): Device; Other
Intervention description(s): SWD group took short wave diathermy with specifications of 400 watt power output, 27.12 MHz frequency, 11.06m wave length, using condensators and electrodes of 12 cm diameter parallel to the knee for 20 minutes(Enraf-Nonius, Curapuls 970 Short wave diathermy device).; Prolotherapy solutions were injected to the knee by a blinded physician in the group, using 25 gauge needle, with solutions being 6 ml 25 % dextrose (3 ml 20% dextrose + 3 ml 30% dextrose) for intraarticular, and 20 ml 15% dextrose (10 ml 0,9% NaCl + 10 ml 30% dextrose) for periarticular. Injection points wwere defined as medial collateral ligaments, adhesion points of quadriceps tendon, adhesion points of patellar tendon, tuberositas tibia, pes anserinus, lateral collateral ligaments, coronal ligaments, medial and lateral tibia plateaus. Patients were blinded to their treatment groups
Other intervention name(s): Hypertonic dextrose injections
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee Osteoarthritis; Prolotherapy; Hypertonic dextrose solution injections; Short-wave diathermy
Digital Assessment of a Full Digital Implant-Prosthetic Workflow for a Prefabricated Single Implant-Supported Restoration
Condition: Dental Implants
Study type: Interventional

Summary: 
      The aim of the present study was to evaluate the accuracy of a prefabricated digitally
      planned provisional restoration on a single- implant placed with a fully guided surgical
      protocol.
    

Detailed description: 
      Fifteen dental implants were placed in partially edentulous patients with single bounded
      lower posterior edentulous area selected from those admitted to the Prosthodontics
      Department, Faculty of Dentistry, Alexandria University. A full digital implant-prosthetic
      protocol was followed and a quantitative evaluation of the accuracy of the protocol was
      performed using computer software and superimposition of the planned and post-operative
      images was done.
    

Intervention name(s): Virtual Implant Planning
Intervention type(s): Other
Intervention description(s): According to the virtual implant plan, a CAD/CAM tooth supported surgical guide will be fabricated to place the dental implant with a fully guided surgical protocol.The surgical guide will be manufactured from a photopolymer resin using a 3D printing machine. A hex- shaped metal sleeve will be inserted in the surgical guide with the flat surface located buccally so that it will help in orientation of the implant hex during the implant placement.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Skin Tests in Cat Allergic Patients With Cat Dander Samples Obtained Before and After Vaccinating the Cat
Condition: Hypersensitivity
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      Determination of allergenicity of cat dander samples obtained before and after vaccinating
      the cat
    


Intervention name(s): Diagnostic skin testing
Intervention type(s): Other
Intervention description(s): 14 Skin prick tests on each volar forearm with cat dander samples.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cat; allergy; dander; Fel d 1; Felis domesticus
A Study to Demonstrate the Efficacy of GSK Biologicals' Influenza Vaccine in Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to demonstrate the efficacy of GSK Biologicals' influenza
      vaccine (Fluarix™) administered intramuscularly in adults.
    


Intervention name(s): Fluarix vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Influenza vaccine; Prophylaxis Influenza vaccine
PK Study of YH22162 FDC Compared to Combination of Twynsta and Hygroton
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Randomized, open-label, single-dose, 2-treatment, 2-period, 2-sequence crossover
      design.
    

Detailed description: 
      This is a 2 by 2 cross-over study to evaluate pharmacokinetics of YH22162 FDC compared to
      reference twynsta and Hygroton co-administered in two groups enrolling healthy adult male
      subjects under fasting conditions.

      Subjects will be admitted to the clinic in the evening before Day 1. All subjects will
      receive a single oral dose of YH22162 FDC or twynsta and Hygroton co-administered in the
      morning on Day 1. All the subjects will remain in the clinical unit until completion of all
      assessments on Day 2 including collection post-dose PK sample. Subjects will return to the
      clinic for pharmacokinetic samples at scheduled time. The two treatment periods will be
      separated by a washout period.
    

Intervention name(s): YH22162; Telmisartan/Amlodipine 80/5 mg (FDC); Chlorthalidone 25mg
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Twinstar 80/5 mg; Hygroton 25mg
Intervention MeSH terms: Amlodipine; Telmisartan; Chlorthalidone; Telmisartan amlodipine combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy
Condition: Nephrectomy; Laparoscopic Donor Nephrectomy
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether continuous intravenous ketorolac infusion
      reduces pain in patients who are having laparoscopic surgery to donate a kidney.
    


Intervention name(s): Ketorolac; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.; 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
Other intervention name(s): Toradol; Acular
Intervention MeSH terms: Ketorolac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: laparoscopic; donor; nephrectomy
Pre-Exposure Prophylaxis (PrEP) Adherence Monitoring Using Dried Blood Spots
Condition: PrEP Adherence Monitoring
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of this study is to define the mean, variance, and dose proportionality
      for tenofovir-diphosphate(TFV-DP) in dried blood spots resulting from 33%, 67%, and 100% of
      daily dosing with 200mg emtricitabine and 300mg of tenofovir disoproxil fumarate (as
      Truvada®). With this information, a model will be established to predict adherence rates to
      TFV-DP using DBS. Forty-eight healthy HIV-uninfected adult participants who are at low risk
      for HIV infection will be randomized to one of 6 sequences consisting of two directly
      observed dosing regimens, 33%/67%, 33%/100%, 67%/33%, 67%/100%, 100%/33%, and 100%/67% with
      each dose regimen lasting approximately 12 weeks, separated by an approximately 12 week
      washout period. DBS will be collected at regular intervals, including during the washout. The
      hypothesis of the study is that levels of TFV-DP in DBS will predict adherence rates in the
      preceding 1-3 months.
    


Intervention name(s): Truvada
Intervention type(s): Drug
Intervention description(s): Truvada is a combination pill consisting of tenofovir and emtricitabine used in PrEP
Other intervention name(s): Tenofovir; Emtricitabine
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pre exposure prophylaxis; Dried blood spots
Incorporating Financial Incentives to Increase Smoking Cessation Among Asian Americans Residing in New York City
Condition: Smoking Cessation; Smoking, Cigarette
Study type: Interventional

Summary: 
      Financial incentives for motivating health change have been increasingly employed in various
      healthcare sectors. They can be a potentially effective approach to promote smoking
      behavioral change and increase the use of evidence-based counseling and pharmacotherapy.
      Smoking cessation randomized clinical trials (RCT) incorporating financial incentives have
      been conducted in different populations; however, there has not been a randomized clinical
      trial coupled with a financial incentive with Asian American cigarette smokers. The purpose
      of this pilot study is to examine the feasibility of implementing an incentivized smoking
      cessation program among Asian American smokers in New York City.
    


Intervention name(s): Financial Incentives
Intervention type(s): Behavioral
Intervention description(s): Baseline Interview, 2 Counseling Sessions at baseline and 2 weeks post baseline, and one follow up survey at one month
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Vitamin D Dose-Response Relationship
Condition: Vitamin D Status
Study type: Interventional

Summary: 
      The purpose of the study is to determine the importance of the UV intensity and the UVB dose
      on the Vitamin D response after UVB.
    

Detailed description: 
      The work is addressing vitamin D production after UVB exposure and explore the importance of
      UVB dose and UV intensity. Four different UVB doses and four different UV intensities are
      used to explore these relationships.

      Many assumptions have been made concerning the vitamin D production after UVB exposure but
      only few studies exist.
    

Intervention name(s): UVB; UVB; UVB; UVB
Intervention type(s): Radiation; Radiation; Radiation; Radiation
Intervention description(s): 0.375 SED x 4 in a week; 0.75 SED x 4 in a week; 1.5 SED x 4 in a week; 3.0 SED x 4 in a week
Other intervention name(s): UVB radiation; UVB radiation; UVB radiation; UVB radiation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Vitamin D; UVB; Dose-Response; UV intensity; Skin cancer