bioihbjkbjnl/mcl2 huggingface dataset:
Can Cholesterol Lowering Drugs Influence Circulating Omega-3 Fatty Acid Levels
Condition: Hypercholesterolemia; Hyperlipidemia
MeSH terms: Hypercholesterolemia; Hyperlipidemias
Study type: Interventional

Summary: 
      The objective of this study is to determine if the administration of a cholesterol lowering
      drug like ezetimibe will reduce circulating omega-3 fatty acid (ALA) levels in patients with
      heart disease and hypercholesterolemia.

      The investigators hypothesize that their data will discover that patients receiving ezetimibe
      require additional dietary supplementation with omega-3 supplements to insure that these
      beneficial fatty acids are available to these patients.
    

Detailed description: 
      All patients will undergo drug therapy as required to treat their clinical symptoms including
      the use of other classes of cholesterol-lowering drugs like statins (that will not interfere
      with intestinal cholesterol levels). One group of patients will be those who in addition to
      there existing drug therapy are prescribed ezetimibe to lower circulating cholesterol
      concentrations. A second group of patients will be those who are not prescribed ezetimibe as
      part of their normal course of therapy. Blood samples will be taken from all patients at the
      study baseline. All patients will be fasted for 12 hours prior to the blood sample being
      taken. After 6 weeks a second blood sample will be taken. This will determine if the drug
      intervention (ezetimibe) influenced the circulating omega-3 fatty acid concentration.

      It will also be of interest to determine if drug administration (ezetimibe) will influence
      this process when higher levels of omega-3 fatty acids are given to the patients by dietary
      supplements of ALA. Two additional groups of patients will consume a flaxseed oil supplement
      containing 1g of ALA in the form of two capsules daily
    

Intervention name(s): Flax seed oil (ALA); Ezetimibe
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): 2 capsules each containing 500mg of ALA will be taken once per day for 6 weeks; In total, 30 patients will receive ezetimibe as a drug intervention. The dosage is 10mg pod for 6 weeks
Other intervention name(s): Jamieson Flax seed oil (ALA)- capsules.
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Omega-3 Fatty acid; ALA (alpha linolenic acid); Ezetimibe; Flaxseed oil capsules
Collagen Treatment in Facial Nerve Palsy
Condition: Facial Nerve Palsy
MeSH terms: Bell Palsy; Facial Paralysis; Facial Nerve Diseases; Paralysis; Facies
Study type: Interventional

Summary: 
      To test the effectiveness of a collagen-based treatment for patients complaining of long
      standing facial nerve axonotmesis, who are following a proprioceptive neuromuscular
      facilitation protocol (Kabat method), compared to a group only undergoing the Kabat method.
    

Detailed description: 
      Objective: To test the effectiveness of a collagen-based treatment for patients complaining
      of long standing facial nerve axonotmesis, who are following a proprioceptive neuromuscular
      facilitation protocol (Kabat method), compared to a group only undergoing the Kabat method.

      Methods: Patients undergoing both procedures will be compared, after randomization, to
      matched patients undergoing only Kabat procedure after 8 weeks of treatment. The outcomes
      will be electromyographic findings, validated questionnaires (Facial Disability Index, FDI)
      and clinical grading (House-Brackmann, HB). A correlation analysis will be performed between
      pre-/post-treatment diﬀerences (Δ) in outcome and clinical-demographic measures.
    

Intervention name(s): Rehabilitation; Collagen Injection
Intervention type(s): Procedure; Procedure
Intervention description(s): The Kabat procedure consists of facilitating the voluntary response of an impaired muscle through a global pattern of an entire muscular section which undergoes resistance. This method considers that harmony, coordination and optimal strength of body movements mainly depend upon the fact that they are performed following diagonal lines with respect to the sagittal axis of the body, thus implying a 'rotational' effect. It will performed twice a week for 8 weeks; With an insulin-type syringe and 30-gauge needle, a bolus of about 0.4 cc per point of the collagen solution will be injected in the orbicularis oculi muscle 1 cm outside the orbital rim and 0.5 cm superior and inferior to the first injection point, respectively, and in the orbicularis oris muscle, where the 2 injection points are on the border between the pars peripheralis and pars marginalis, located about 5 mm above the superior and inferior vermilion, respectively
Other intervention name(s): Kabat procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Facial nerve palsy; Kabat method; Collagen injections; Electromyography
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials of Org 36286 (Study 38817)(P06054)(COMPLETED)
Condition: Pregnancy
Study type: Observational

Summary: 
      The objective of this trial was to evaluate whether Org 36286 treatment in any Phase IIa
      clinical development trial of Org 36286 for OI or COH in assisted reproductive treatment
      programs was safe for pregnant subjects and their offspring. Data from subjects who
      participated in Trials 38805 and 38807 and became pregnant were evaluated.
    

Detailed description: 
      This was an open prospective follow-up trial to monitor pregnancy, delivery, and neonatal
      outcome of women who became pregnant during any Phase IIa clinical trial of Org 36286 for OI
      or COH for IVF. For this trial, no study specific assessments were required, but information
      obtained in standard practice was used.
    

Intervention name(s): Org 36286 (corifollitropin alfa); Placebo; recFSH
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single dose of Org 36286 (corifollitropin alfa) administered under protocol 38805/38807; single dose of placebo (administered under protocol 38805); 150 IU recFSH daily (reference group administered under protocol 38807)
Other intervention name(s): corifollitropin alfa; follitropin beta; Puregon®; Follistim®
Intervention MeSH terms: Follicle Stimulating Hormone
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All women who became pregnant during Trials 38805 or 38807 were enrolled in Trial 38817
      
Keywords: Neonatal outcome; Congenital malformations; In-Vitro Fertilization; Controlled ovarian stimulation; Follow-up; Ovulation Induction; Neonates
e-CHEC-uP: Scaling up an Efficacious Cancer Screening Intervention for Women With Limited English
Condition: Breast Cancer; Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      This research is being done to learn more about whether or not Korean American women will
      improve the screening practices for breast and cervical cancer if subjects receive education
      and follow-up from community health workers. The education materials may be given via online
      or in-person. Primary Hypothesis: e-CHEC-uP will be as efficacious as the original CHEC-uP in
      promoting mammogram and Pap test screening among Korean immigrant women (KIW) at 6 months.

      Objectives: (1) To develop a web-based platform of the health literacy education component of
      the original CHEC-uP intervention; (2) To evaluate the acceptability and usability of the web
      version of the health literacy education in a user testing sample of 10 KIW; and (3) To
      conduct a pilot study to test the preliminary efficacy of the web version of CHEC-uP
      (e-CHEC-uP) in 40 KIW.
    

Detailed description: 
      e-CHEC-uP stands for e-Community based breast and cervical cancer control education program.
    

Intervention name(s): e-CHEC-uP; CHEC-uP
Intervention type(s): Behavioral; Behavioral
Intervention description(s): One time online-based education about breast and cervical cancer screening procedures followed by phone counseling by trained community health worker over 6 months; One time face-to-face education about breast and cervical cancer screening procedures followed by phone counseling by trained community health worker over 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
A Study of ULTRAM ER at Two Dose Levels in Adolescents With Pain
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetic (PK) of single oral doses of
      ULTRAM Extended Release (ER) at 2 dose levels in adolescents between 12 and 17 years old,
      inclusive (up to 17 years 364 days) with pain due to injury or nonmalignant disease, to the
      PK in adults, with respect to the PK parameter AUC∞ (area under the curve) of racemic
      tramadol. PK explores how the drug is absorbed in the body, distributed within the body, and
      how it is removed from the body over time.
    

Detailed description: 
      This is a multicenter, open-label (all people know the identity of the intervention),
      2-group, single dose study. Within each group of participants for Parts 1 and 2, at least 1/3
      of the participants will be female, at least 1/3 of the participants will be male, at least
      1/3 of the participants will be below the age of 14 years, and at least 1/3 of the
      participants will be above the age of 16 years. Participants will be assigned to 1 group
      only. Each group of participants will receive a single oral dose of ULTRAM ER on 1 occasion.
      Group 1 will receive a dose of ULTRAM ER that is closest to 2 mg/kg, based on the
      participant's body weight and adjusting the dose in 25 mg increments. Following completion of
      all evaluations of Group 1, the pharmacokinetic data will be evaluated to target a dose for
      Group 2 that will achieve a level of exposure similar to that seen with a single 200 mg
      ULTRAM ER dose in adults. The maximum dose of ULTRAM ER should not exceed 6 mg/kg or 300 mg.
      When the study physician, the investigators, and the medical monitors agree that the PK of
      the drug is well-characterized and that the drug is well tolerated, enrollment will begin for
      Group 2 of the study. The sponsor's responsible Medical Officer will evaluate the safety of
      the calculated dose in Group 2 participants by evaluation of adverse drug events paying
      particular attention to events suggestive of either opioid toxicity or serotonin toxicity.
    

Intervention name(s): ULTRAM ER; ULTRAM ER
Intervention type(s): Drug; Drug
Intervention description(s): One dose of ULTRAM ER that is closest to 2 mg/kg, based on the participant's body weight and adjusting the dose in 25 mg increments.; The target dose for Group 2 will be the one that achieves a level of exposure similar to that seen with a single 200 mg ULTRAM ER dose in adults.
Intervention MeSH terms: Tramadol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; ULTRAM ER; Tramadol hydrochloride; Adolescents
Comparison of Zinc Oxide Eugenol to Ferric Sulphate Pulpotomy in Primary Teeth
Condition: Pulpotomy
Study type: Interventional

Summary: 
      In this prospective randomized, single blinded; split-mouth clinical trial the aim was to
      evaluate clinical and radiographic effects of placement of reinforced zinc oxide eugenol
      (ZOE) base directly over the amputated pulp stumps in pulpotomized primary molars, and to
      compare this technique to ferric sulphate (FS) in pulpotomized primary teeth. Included were
      65 children using a split-mouth design, (130 teeth). All teeth were then restored with
      prefabricated stainless steel crowns (SSC). Patients were recalled for clinical and
      radiographical evaluation after 3, 6, 12 and 24 months. Two experienced and calibrated
      pediatric dentists who were not involved in the investigation blindly assessed the
      radiographs.
    

Detailed description: 
      Purpose:

      The purpose of this study was to evaluate the clinical and radiographic effects of placement
      of reinforced zinc oxide eugenol (ZOE) base directly over the amputated pulp stumps in
      pulpotomized primary molars, and to compare the effects of this technique to ferric sulphate
      (FS) agent in pulpotomized primary teeth.

      Methods:

      A sample of 65 children with bilateral deep carious mandibular primary molars who attended
      the pediatric dental clinics, at Jordan University of Science and Technology (JUST) were
      selected for this prospective randomized, single blinded; split-mouth clinical trial. The
      teeth were randomly divided into 2 treatment groups: in the ZOE group (n=65 teeth) hemostasis
      was achieved by a dry cotton pellet, then the chamber was filled with zinc oxide eugenol
      (ZOE) directly over the pulp on one side. In the FS group (n=65 teeth) hemostasis was
      achieved by a wet cotton pellet, ferric sulphate (FS) was applied on the pulp, then the
      chamber was filled with (ZOE) on the contralateral side. All teeth were restored with
      prefabricated stainless steel crowns (SSC). Patients were recalled for evaluation clinically
      after 1month, then clinically and radiographically after 3, 6, 12 and 24 months. Two
      experienced and calibrated pediatric dentists who were not involved in the investigation
      blindly assessed the radiographs.
    

Intervention name(s): Pulp hemostasis with a dry cotton pellet; Pulp hemostasis with a wet cotton pellet impregnated with FS; Stainless steel crown
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Application of a dry cotton pellet, then the chamber was filled with ZOE directly over the pulp; Application of a a wet cotton pellet impregnated with FS, then the chamber was filled with ZOE directly over the pulp; Stainless steel crown placed as a final restoration
Intervention MeSH terms: Hemostatics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ferric sulphate; Zinc Oxide Eugenol; Pulpotomy; Primary dentition
Fever and Wheezing Events in Children After US Influenza Vaccines Using Text Messaging
Condition: Fever; Wheezing
MeSH terms: Fever; Respiratory Sounds
Study type: Interventional

Summary: 
      Children 2-11 years of age who are given the influenza vaccine (inactivated influenza (IIV)
      or live attenuated influenza vaccine (LAIV)) as part of their routine care can enroll in this
      study if their parent has the ability to receive and send text messages. Children enrolled in
      this study will be observed daily for an eight-day period starting on the day of vaccine
      administration, and then continuing over the next 7 days, and then weekly for 42 days. On the
      day of enrollment and nightly for the next seven days, the parent will report via text
      message what their child's highest temperature is. If fever is present, they will then be
      prompted for additional information including other symptoms, antipyretic use and medical
      care sought. On day 3 as well as weekly from day 7 through day 42 post-vaccination, parents
      will be asked via text message about breathing problems, specifically cough, wheezing and
      chest tightness. They will also be asked about medications taken and care sought. The purpose
      of this study is to assess the feasibility of collecting this data.
    


Intervention name(s): text message
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Study to Evaluate the Efficacy and Safety of KBP-042 in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicentre, randomized, double-blind, placebo-controlled, parallel-group Phase II
      trial of twelve weeks of KBP-042 administered as daily s.c. injections in subjects with Type
      2 Diabetes Mellitus with inadequate glycaemic control while treated with a stable dose of
      metformin.

      The trial is planned to be performed in Czech Republic, Denmark, Moldova, Poland, Romania and
      United Kingdom
    


Intervention name(s): Daily injection of KBP/placebo for 12 weeks as add-on to metformin
Intervention type(s): Drug
Intervention description(s): Daily subcutaneous injection
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; KBP-042
The Effect of Cherry Seed Pillow on Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      In this study, the effects of 4-week Cherry seed pillow application on pain and quality of
      life in individuals diagnosed with fibromyalgia will be examined.
    


Intervention name(s): Cherry seed pillow; Control
Intervention type(s): Other; Other
Intervention description(s): 4 Weeks, 5 days a week, in addition to the routine physiotherapy application, 20 minutes of heated cherry seed pillow will be applied to the participant's back area.; 4 Weeks, 5 days a week, in addition to the routine physiotherapy application, 20 minutes of hotpack will be applied to the participant's back area.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Bioequivalence Study of Dasatinib Tablet
Condition: Leukemia, Myelogenous, Chronic
MeSH terms: Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a clinical study to evaluate the bioequivalence of dasatinib tablet produced by Chia
      Tai Tianqing Pharmaceutical Group Co., Ltd. and Sprycel® produced by Bristol Myers Squibb
      after single dose in healthy subjects, so as to provide reference for clinical evaluation and
      clinical medication; to observe the safety of the dasatinib tablet and the reference drug
      Sprycel® in healthy subjects under fasting and fed states.
    


Intervention name(s): CTTQ Dasatinib tablet; Sprycel Dasatinib tablet
Intervention type(s): Drug; Drug
Intervention description(s): Dasatinib tablet is an oral tyrosinekinase inhibitor produced by Chia Tai Tianqing Pharmaceutical Group.; Sprycel Dasatinib tablet is an oral tyrosinekinase inhibitor produced by Bristol Myers Squibb.
Intervention MeSH terms: Dasatinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Morphological Pattern of the Atrophic Posterior Maxillae
Condition: Bone Deficiency, Posterior Maxillae
Study type: Observational

Summary: 
      Overcoming the vertical and horizontal bone deficiency in the posterior maxillae are
      considered as the most challenging scenarios for implant-supported oral rehabilitation in
      modern implant dentistry. Therefore, a comprehensive and precise understanding of such
      anatomical structures are needed to avoid potential complications that ultimately might
      jeopardize the treatment outcome.

      Cone-beam computerized tomography (CBCT) offers some advantages to conventional CT-scan such
      as lower-dose radiation with high isotropic spatial resolution and cost. Therefore, it offers
      a viable and reliable tool to study anatomical structures such as the posterior atrophic
      maxillae
    


Intervention name(s): Cone-beam computed topography
Intervention type(s): Radiation
Intervention description(s): This study used a retrospective database of preexisting data that included patients treated as part of routine periodontal and oral surgery therapy for each patient's needs. All the patients signed an inform consent approving using their radiographic data for research purposes.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study used a retrospective database of preexisting data that included patients treated
        as part of routine periodontal and oral surgery therapy for each patient's needs. All the
        patients signed an inform consent approving using their radiographic data for research
        purposes.
      
Keywords: Bone; Maxilla; Cone-Beam Computed Tomography; Regeneration
Combination of Topiramate and Empagliflozin is Considered a Good Option for the Treatment of Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Observational [Patient Registry]

Summary: 
      The aim was to show if a combination of topiramate and empagliflozin have the greatest weight
      decreasing effect in comparison to each drug alone and to group with no treatment( control
      group).

      .
    

Detailed description: 
      The aim was to show if a combination of topiramate and empagliflozin have the greatest weight
      decreasing effect in comparison to each drug alone and to group with no treatment( control
      group).

      Materials and methods 200 obese patients 4 groups. had been monitored in a private clinic,
      each group 50 patients number, with 35 females and 15 males who were already on treatment.
    

Intervention name(s): The intervention being studied
Intervention type(s): Drug
Intervention description(s): Intervention Other Names have not been specified
Other intervention name(s): "empagliflozine", "jardiance®"); "topiramate", "conviban®"
Intervention MeSH terms: Topiramate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        obese peoples , age from 35 to 55 years
      
Keywords: obesity; drug combination; empagliflozin(jardiance); topiramate(conviban)
NCPAP + Heliox as a Treatment for Infant Respiratory Distress Syndrome (RDS)
Condition: Respiratory Distress Syndrome; Bronchopulmonary Dysplasia
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Bronchopulmonary Dysplasia; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Infants born between 28 and 32 weeks' gestation with radiological findings and clinical
      symptoms of moderate RDS, requiring respiratory support with Nasal Continuous Positive Airway
      Pressure (NCPAP) within the first hour of life, were randomized to receive either standard
      medical air or a Heliox/Oxygen mixture 80/20 (Heliox) during the first 12 hours of life,
      followed by medical air until NCPAP was needed. The aim of the study was to assess the
      therapeutic effects of breathing a low-density gas mixture (heliox: 80% helium and 20%
      oxygen) in premature babies with Respiratory Distress Syndrome (RDS), undergoing NCPAP in
      terms of reducing the rate of mechanical ventilation (MV).
    


Intervention name(s): NCPAP + standard air; NCPAP + Heliox
Intervention type(s): Other; Other
Intervention description(s): NCAP (SiPAP, Vyasis) was used to administer standard air; Heliox21 (mixture of Helium 80%- Oxygen 20%) (BOC Medical UK- The Linde group) was stored in 10 liter cylinders and administrated through NCPAP for 12 hours (study period) starting from randomization.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: preterm infants; nasal continuous positive airway pressure; heliox; bronchopulmonary dysplasia.