bioihbjkbjnl/mcl2 huggingface dataset:
Fish Oil and Folate Supplementation During Pregnancy
Condition: Perinatal DHA and Folate Status; Neurological Development
Study type: Interventional

Summary: 
      Pregnant women are randomised to supplementation with fish oil, methyl tetrahydro folic acid,
      both or a placebo during the second half of pregnancy. Biochemical measures are determined in
      maternal blood during pregnancy and in cord blood.

      Non invasive follow up examinations of infants at ages 4, 5.5, 6.5, 7.5, 8, 9 and 9.5 years
      focus on long term effects of supplementation anthropometric development, neurological
      development and allergy risk.
    


Intervention name(s): fish oil; folate; fish oil + folate; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 400 mg of DHA and 150 mg of eicosapentaenoic acid per day; 400 µg per day; 500 mg DHA, 150 mg eicosapentaenoic acid, 400 µg MTHF per day; only vitamins and minerals as recommended, but no fish oil or folate
Intervention MeSH terms: Folic Acid; Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: docosahexaenoic acid; folate; neurological development; allergies; long term consequences for the offspring; allergy risk
A Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers
Condition: Smoking
Study type: Interventional
Phase: Phase 1

Summary: 
      Bioequivalence study to confirm that a NTS with a polyisobutylene (PIB) adhesive from an
      alternative supplier delivers the same nicotine blood profile as that of the currently
      approved NTS with a polyisobutylene adhesive from the current supplier.
    


Intervention name(s): nicotine
Intervention type(s): Drug
Intervention description(s): nicotine transdermal patch
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
A Phase II Trial of Afatinib(BIBW 2992) in Third-line Treatment for Patients With Stage IIIB/IV Adenocarcinoma of the Lung Harbouring Wild-type Epidermal Growth Factor Receptor[EGFR]
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Adenocarcinoma; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      To explore the efficacy of BIBW 2992 defined by the objective response rate (Complete
      Response, Partial Response) as determined by Response Evaluation Criteria in Solid
      Tumours[RECIST] 1.1 in the patients with advanced (stage IIIB or IV) adenocarcinoma of the
      lung harbouring wild-type EGFR.
    


Intervention name(s): afatinib (BIBW 2992)
Intervention type(s): Drug
Intervention description(s): afatinib (BIBW 2992) po QD
Intervention MeSH terms: Afatinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Transcranial Direct Current Stimulation for Migraine Attack
Condition: Acute Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      This study is conducted to investigate the therapeutic efficacy and safety of transcranial
      direct current stimulation (tDCS) over the primary motor cortex of patients with acute
      migraine attack.
    


Intervention name(s): transcranial direct current stimulation
Intervention type(s): Procedure
Intervention description(s): A constant current of 2 mA intensity applied for 20 min over C3 or C4
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neck Kinesiotherapy and Massage in Tinnitus Treatment
Condition: Subjective Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      The primary aim of this study is to investigate the effectiveness of cervical spine
      kinesiotherapy and massage in tinnitus treatment. Furthermore, we investigate if there is a
      link between cervical spine range of motion and cervical muscles tension and tinnitus.
    

Detailed description: 
      The study is planned with power of 80%. A total of 118 adult patients with subjective
      tinnitus are divided into two groups: Kinesiotherapy group (n=59) and Waiting list group
      (n=59).Kinesiotherapy group receives a complex set of cervical spine exercises and neck
      massage for consecutive 10 working days (entire treatment takes two weeks). Each visit lasts
      around 30 minutes. Patients from kinesiotherapy group will fill the outcome measures on the
      following time points: (a) Time point 0 - baseline (b) Time point 1- Two weeks after the
      baseline

      (c) Time point 2- Four weeks after the baseline. Individuals from waiting list group are
      enrolled on a waiting list and do not receive any treatment. They undergo assessment at three
      time points corresponding to Kinesiotherapy group i.e Time point 0, Time point 1 and Time
      point 2.

      .
    

Intervention name(s): Complex set of kinesiotherapy of cervical spine and delicate massage
Intervention type(s): Other
Intervention description(s): Intervention:- A complex neck therapy.Treatment comprises 10 sessions performed on consecutive working days, includes four parts.
Active exercises of the neck, 5 minutes, first demonstrated by the physiotherapist and next the patient performs them under supervision, 5 repetitions of each of the following: cervical flexion, rotation to the left and to the right, side bending to the left and to the right, torsion to left and right.
Massage of cervical interspinales muscles performed by therapist 3 minutes.
Post Isometric Relaxation (PIR) performed by physiotherapist. 15 minutes.
Active neck exercises - the same as mentioned in step 1. 5 minutes. Total duration of one treatment session is around 30 minutes.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: It is a non randomized controlled trial
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Subjective tinnitus,; massage; Post Isometric Relaxation Exercises; Kinesiotherapy
Sphenopalatine Ganglion Block Versus Occiptal Nerve Block in Treatment of Post Dural Puncture Headache
Condition: Headache
MeSH terms: Headache
Study type: Interventional

Summary: 
      Postdural puncture headache (PDPH) is a common complication associated with neuraxial
      anesthesia and diagnostic lumbar puncture (LP). PDPH is defined as a bilateral headache that
      develops within 7 days and disappears within 14 days after the dural puncture with a distinct
      postural quality. PDPH causes significant short-term disability, prevents ambulation and care
      of the newborn (in obstetrics), and results in a prolonged hospital stay.
    

Detailed description: 
      The sphenopalatine ganglion (SPG) is an extra-cranial neural structure located in the
      pterygopalatine fossa that has both sympathetic and parasympathetic components as well as
      somatic sensory roots. The trans-nasal approach is a low risk, noninvasive technique that is
      easily performed and could potentially be beneficial in the treatment of PDPH through
      blocking the parasympathetic ﬂow to the cerebral vasculature through the sphenopalatine
      ganglion which will allow the cerebral vessels to return to normal diameter and thus relieve
      the headache.

      The greater occipital nerve contains sensory fibers from C2 and C3 segments of medulla
      spinals. It arises from the dorsal ramus of C2 segment, contains a thin branch from C3
      segment, and innerves the medial aspect of posterior scalp up to the anterior aspect of
      vertex. Greater occipital nerve block (GONB) inhibits the pain sensation of this region.

      There is some evidence to suggest the effectiveness of GONB in the management of PDPH.
      Nowadays, guidelines for the management of PDPH were modified and included GONB as a part of
      standard management of PDPH.

        -  Dexamethasone possess potent antiinflammatory and immunosuppressive actions by
           inhibiting cytokine-mediated pathways.

        -  Many providers believe that the local anesthetic produces the rapid onset of headache
           relief, like an abortive agent, and that the locally acting steroid produces the
           preventive like action of up to 6 weeks.
    

Intervention name(s): Sphenopalatine block; Greater occipital nerve block
Intervention type(s): Procedure; Procedure
Intervention description(s): patients will receive bilateral sphenopalatine ganglion block using 3ml mixture of 2ml 2% lidocaine plus 1ml dexamethasone 4mg (on each nostril).; patients will receive bilateral greater occipital nerve block using a mixture of 3ml of 2ml 2% lidocaine plus 1ml dexamethasone 4mg (on each side of the occipital region).
Other intervention name(s): SPGB; GONB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Endoscopy in CKD With Iron Deficiency Anemia
Condition: Chronic Kidney Diseases; Iron-Deficiency Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional

Summary: 
      Iron deficiency anemia is very common in CKD patients. Data about gastrointestinal lesions in
      Arab patients are insufficient.
    

Detailed description: 
      Iron deficiency anemia without gastrointestinal symptoms needs to be assessed in patients
      with chronic kidney disease.
    

Intervention name(s): Upper GIT endoscopy
Intervention type(s): Procedure
Intervention description(s): Upper gastrointestinal endoscpy for all participants and gastric biopsy for histopathological examination for suspicious lesions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Evaluating Trauma-Informed, Evidence-Informed Interventions for Latino Families Experiencing Domestic Violence
Condition: Interpersonal Relations
Study type: Interventional

Summary: 
      This project will evaluate the implementation and efficacy of a domestic violence
      intervention module for parents receiving child welfare home visitation services.
    

Detailed description: 
      The ultimate goal of this proposed project is the provision of culturally-relevant,
      trauma-informed services leading to a reduction of family violence, and a resultant increase
      in family stability, improved communication, and a healthy home environment for children in
      Latino families with co-occurring domestic violence (DV) and child abuse/neglect (CAN). The
      Administration for Children, Youth and Families (ACYF) funded project and evaluation will be
      layered onto the existing UC San Diego's NIH-funded R01 research (NIH R01 MH092950) on
      scale-up of SafeCare (SC) across the entire San Diego Child Welfare System. In the first
      phase of this project, the community and academic partners will collaborate to develop a
      detailed evaluation plan by collecting formative qualitative data via focus groups with
      active CW clients with domestic violence (DV) histories and community child welfare and DV
      service providers. The second phase of this project will begin with the implementation of
      SafeCare+ (SC+), an evidence-based training curriculum for parents referred for child
      maltreatment, coupled with the Healthy Relationships (HR) module for Latino families with
      co-occurring child maltreatment and domestic violence experiences. SafeCare® (SC) has been
      shown to be widely accepted among the Latino community and the HR module has been
      specifically adapted for and successfully utilized with Latino populations. As part of the
      expansion of the original research study, 80 clients who will be recruited into the existing
      study will also be randomly assigned to receive the additional HR module.
    

Intervention name(s): SafeCare+ (SC+); SafeCare (SC)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): SafeCare intervention with the additional Healthy Relationships (HR) module; SafeCare intervention as usual
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: healthy relationships; interpersonal relations; domestic violence
Pharmacokinetics Study on Nevirapine Resistance in Tanzania
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary

        -  pharmacokinetics of single dose nevirapine

        -  the effect of single dose carbamazepine on the pk of single dose nevirapine

        -  resistance against nevirapine before and after.

        -  follow-up on HIV status newborns

        -  relation between nevirapine levels in cord blood and plasma

      Secondary

      * safety of single dose nevirapine and nevirapine/carbamazepine

      Hypothesis:

      Single dose carbamazepine decreases development of resistance to nevirapine in HIV positive
      pregnant Tanzanian women by decreasing nevirapine half-life.
    

Detailed description: 
      Without the use of preventative measures, the risk of mother-to-child transmission (MTCT) of
      HIV-1 is estimated to vary between 25 and 48%. The regimen of single dose of nevirapine to
      the mother just before delivery and a single dose of nevirapine to the newborn within 24 - 72
      hours after birth reduces the risk of MTCT by 50%, is affordable in many situations and is
      therefore standard of care in many African countries, like Tanzania. Recent studies, however,
      have shown that this single dose to the mother can induce the occurrence of nevirapine
      resistance in a large number of mothers. The mechanism of occurrence of nevirapine resistance
      already after a single dose is most likely related to the long elimination half-life of the
      drug. The subtherapeutic plasma levels present the perfect environment for the occurrence of
      resistance as the concentrations are subinhibitory for several days.
    

Intervention name(s): carbamazepine and nevirapine; Nevirapine
Intervention type(s): Drug; Drug
Intervention description(s): Carbamazepine 400mg and Nevirapine 200mg are taken just before delivery during labor.; Nevirapine 200mg is taken prior to delivery during labor.
Intervention MeSH terms: Nevirapine; Carbamazepine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; mother to child transmission; MTCT; nevirapine resistance; pharmacokinetics; Treatment Naive
Fractional Ablative Radiofrequency for the Treatment of Acne Scars and Wrinkles
Condition: Wrinkles; Acne Scars
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      To assess the safety and efficacy of the Pixel RF (fractional radio frequency) module in the
      treatment of acne scars and wrinkles.
    

Detailed description: 
      The study design will be a prospective open label study. Up to 20 subjects of both genders
      with acne scars and/or wrinkles in the face will be recruited. The subjects will be treated
      once on clean acne scarred skin and three times on the the wrinkled skin with the Pixel RF
      handpiece. Each treatment duration will be approximately 30 minutes. The initial power and
      number of passes parameters shall be set according to the clinical indication and skin type
      of the subject treated (as well as the results of test sites).

      Clinical improvement will be assessed by the investigator physician from the visual
      appearance of the treated area according to the following scale: -1 for exacerbation, 0 no
      change, 1 for 1%-25% improvement, 2 for 25%-50% improvement, 3 for 50%-75% improvement, and 4
      for 75%-99% improvement. Adverse side effects will be scored by clinical evaluation of
      erythema, edema, and burns. Real-time assessments will be made as well by the investigators.
      Treatment and results will be documented in a Case Report Form and follow-up sessions (1, 5
      days after the treatment and 1 month and 3 months after the treatment).
    

Intervention name(s): Alma Lasers Accent RF Pixel handpiece
Intervention type(s): Device
Intervention description(s): Treatment with fractionated RF Pixel device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: wrinkles; acne scars
Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa
Condition: Anemia; Dialysis-dependent Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 open-label efficacy, safety, and pharmacokinetic/pharmacodynamic (PK/PD)
      study to evaluate oral Vadadustat for the treatment of anemia in hemodialysis participants
      converting from Epoetin Alfa therapy.
    

Detailed description: 
      This is a Phase 2, randomized, open-label study to evaluate efficacy and safety of oral
      Vadadustat for the treatment of anemia in hemodialysis participants converting from Epoetin
      Alfa therapy. The study will be conducted in two parts running in parallel: Part 1, Main
      Study in a hemodialysis population on maintenance treatment with Epoetin Alfa; Part 2 is in a
      hemodialysis population that are erythropoiesis-stimulating agent (ESA) hyporesponders on
      maintenance treatment with Epoetin Alfa. For all participants (Main and ESA hyporesponder
      parallel study), the study will include a Screening Period, a Treatment Period, and a Safety
      Follow-Up Period. PK and PD sampling will be done throughout the study. The aim is to achieve
      and maintain hemoglobin (Hb) levels within the target range of 10.0 to 11.0 grams per
      deciliter (g/dL), inclusive, while targeting the middle of the range and minimizing
      excursions outside the target range.
    

Intervention name(s): Vadadustat; Epoetin Alfa; Vadadustat TIW
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Vadadustat Tablets 150 mg; Epoetin Alfa; Oral Vadadustat
Other intervention name(s): AKB-6548; Procrit; Epogen
Intervention MeSH terms: Epoetin Alfa; Glycine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Open-Label, Active-Controlled
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vadadustat; AKB-6548; Anemia; Chronic kidney disease (CKD); erythropoietin
BeatMG: Phase II Trial of Rituximab In Myasthenia Gravis
Condition: Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Study type: Interventional
Phase: Phase 2

Summary: 
      The specific primary objective of this study is to determine whether rituximab is a safe and
      beneficial therapeutic for Myasthenia Gravis (MG) that warrants further study in a phase III
      efficacy trial.
    

Detailed description: 
      Investigators plan on conducting a multicenter randomized, double-blind, placebo controlled
      Phase II clinical trial utilizing a futility design. The study would include acetylcholine
      receptor (AChR) antibody positive generalized MG subjects. This study also presents a unique
      opportunity to study both drug and disease mechanisms because unlike many other autoimmune
      diseases in which rituximab has been used, MG affords the investigation of antigen-specific
      components that participate in the immunopathology of the disease, namely autoantibodies,
      autoantibody-producing B cells, and antigen-specific T cells. This work will further our
      understanding of MG immunopathology and it represents the first step toward gaining a more
      complete understanding of the immune mechanisms underlying treatment of MG with rituximab
      leading to new ways to treat the disease.

      The specific aim of this study is to determine whether rituximab is a safe and effective
      treatment for subjects with MG.

      The SNOMED code for MG is 31839002.
    

Intervention name(s): Rituximab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intervention (rituximab): The treatment group will receive a total of two cycles of rituximab separated by 6 months. Each cycle is defined as one infusion (375mg/m2 IV) per week for four consecutive weeks; The placebo group will receive a vehicle control infusion
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Myasthenia Gravis; Rituximab; SNOMED code 31839002
Cesarean Skin Incision Trial
Condition: Wound Complication
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to determine if there is a difference between Pfannenstiel and
      midline vertical skin incision at time of cesarean section in preventing wound complications
      in the morbidly obese patient. This is a comparative effectiveness study of two commonly-used
      skin incisions. The investigators plan to enroll morbidly obese obstetrical patients upon
      admission and randomize them to one of the above incision types in the operating room. The
      investigators will follow them for 6 weeks post-op to evaluate for wound complications. There
      is minimal risk to the participant as both incision types are acceptable in current
      obstetrical practice. There is no direct benefit to the patient.

      Currently, there is no level I evidence to support either Pfannenstiel or midline vertical
      skin incision in the prevention of wound complications in the obese patient undergoing
      cesarean section. Therefore, current practice is for the surgeon to make the decision based
      on preference and weighing theoretic risks. Therefore, there is clinical equipoise. Cesarean
      section is a very common procedure, with a national rate of 32% of all live births in 2007.
      Not only does obesity increase the expectant mother's risk of a cesarean section, it is also
      a well recognized risk factor for wound complication. The cesarean wound complication rate in
      the morbidly obese population at the University Of Texas at Houston - Memorial Hermann
      Hospital Texas Medical Center in 2011 was roughly twenty times as high as the normal weight
      population, 28% compared to 1.4%. Results from this study could be extrapolated in the future
      to affect lower post-operative morbidity, higher patient satisfaction, less antibiotic use,
      shorter hospital stay, and overall lower health care costs.
    


Intervention name(s): Pfannenstiel incision; vertical skin incision
Intervention type(s): Procedure; Procedure
Intervention description(s): Pfannenstiel incision at time of cesarean section; vertical skin incision at time of cesarean section
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: wound; infection; cesarean delivery; obesity