bioihbjkbjnl/mcl2 huggingface dataset:
Carbohydrate Restriction for Gestational Diabetes Mellitus
Condition: Gestational Diabetes Mellitus (GDM)
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      There is evidence that controlling total amount of carbohydrates is a strategy for
      controlling glucose levels in diabetes mellitus. There is not major evidence that any given
      macronutrient percentage may be recommended to treat a woman with Gestational Diabetes
      Mellitus (GDM). In the investigators' country, insulin is the second-line treatment once
      medical nutrition therapy (MNT) has failed to control glucose levels during pregnancy.
      Insulin treatment is more expensive and not as well accepted as MNT. The investigators have
      designed a randomized-controlled trial to assess whether a diet with 40% total calories from
      carbohydrates may reduce the need of insulin treatment in women with gestational diabetes,
      without having unfavourable pregnancy outcomes, in comparison with a diet with 55% total
      calories from carbohydrates.
    


Intervention name(s): Low CHO; High CHO diet
Intervention type(s): Behavioral; Dietary Supplement
Intervention description(s): Diet with 40% total calories from carbohydrates. In the "Low-CHO" arm, 15% of calories from carbohydrates will be substituted by monounsaturated fat.; Diet with 55% total calories from carbohydrates.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Gestational diabetes; Carbohydrate; Diet; Insulin
Effect of Oral Supplements on the Nutritional Status of Locally Advanced Nasopharyngeal Carcinoma Patients
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Malnutrition is very common in locally advanced nasopharyngeal carcinoma(NPC) patients
      undergoing current chemoradiotherapy (CRT) due to dysphagia, mucositis, nausea and other
      treatment-related problems. Malnutrition is associated with lower physical functioning, lower
      immune status, more severe (grade III/IV) late RT-induced toxicities, treatment interruption
      of chemo(radio)therapy, lower chemotherapy response rates, hospital readmission, impaired
      quality of life (QoL), and increased mortality. Although the international guidelines
      recommend early nutritional support in the presence of nutritional risk, the best type of
      nutritional intervention is still unclear. Individualized dietary counseling showed
      beneficial effects in nutritional intake, nutritional status and QoL in head and neck cancer
      patients undergoing RT or CRT-treatment; oral nutritional supplements (ONS) was most
      acceptable in Chinese NPC patients. Previous nutritional intervention trials in head-neck
      cancer patients have been conducted on small samples and did not clarify the role of oral
      nutritional supplements (ONS). Accordingly, although current guidelines recommend as grade A
      the use of ONS associated with dietary counseling for head-neck cancer patients undergoing
      RT, the efficacy of this nutritional intervention still needs to be evaluated in adequately
      sized and randomized clinical trials for Chinese NPC patients.
    


Intervention name(s): Healing Elements,Methuselah Medical Technology
Intervention type(s): Dietary Supplement
Intervention description(s): ONS group will receive Healing Elements ONS everyday during CRT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nutritional status; nasopharyngeal carcinoma; Nutritional Counseling; concurrent chemoradiotherapy; oral nutritional supplements
Food Effect Study of Codeine Sulfate
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The study was designed to assess the effect of food on the absorption of codeine from Roxane
      Laboratories' 60 mg Codeine Sulfate tablet
    


Intervention name(s): Codeine Sulfate
Intervention type(s): Drug
Intervention description(s): Tablet
Intervention MeSH terms: Codeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intrathecal Magnesium and Postoperative Analgesia
Condition: Total Hip Replacement
Study type: Interventional
Phase: Phase 3

Summary: 
      Magnesium is implicated in the activation of NMDA receptors by amino-excitatory acids in the
      central nervous system [1]. Magnesium deficiency is associated to an increased activation of
      these receptors, and to an increased sensitivity to pain in animals. Spinal cord is the site
      of sensitization of pain, mainly mediated by the NMDA receptors, and intrathecal magnesium
      may have anti-hyperalgesic effect when administered intrathecally [2]. As intrathecal
      magnesium has already been used in humans for treatment of eclampsia, we stated that it could
      also improve postoperative analgesia and reduce the need for auto-administered morphine if
      given (50 mg of magnesium sulfate) with the intrathecal anesthetic drugs (bupivacaine and
      sufentanil) injected for orthopedic surgery.
    

Detailed description: 
      Magnesium is implicated in the activation of NMDA receptors by amino-excitatory acids in the
      central nervous system [1]. Magnesium deficiency is associated to an increased activation of
      these receptors, and to an increased sensitivity to pain in animals. Spinal cord is the site
      of sensitization of pain, mainly mediated by the NMDA receptors, and intrathecal magnesium
      may have anti-hyperalgesic effect when administered intrathecally [2]. As intrathecal
      magnesium has already been used in humans for treatment of eclampsia, we stated that it could
      also improve postoperative analgesia and reduce the need for auto-administered morphine if
      given (50 mg of magnesium sulfate) with the intrathecal anesthetic drugs (bupivacaine and
      sufentanil) injected for orthopedic surgery.
    

Intervention name(s): intrathecal magnesium sulfate
Intervention type(s): Drug
Intervention description(s): intrathecal magnesium sulfate
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Magnesium; Pain; Morphine; Intrathecal; NMDA; Elective total hip replacement under intrathecal anesthesia
Changes in the Upper Airway Volume After Rapid Maxillary Expansion in Adults Using Pure Skeletal Anchorage
Condition: Orthodontic Appliance Complication; Dental Malocclusion; Bone Anchored Rapid Maxillary Expansion; Maxillary Hypoplasia; BAME
MeSH terms: Malocclusion
Study type: Observational [Patient Registry]

Summary: 
      The objective of this study is to evaluate the effect of bone-anchored rapid maxillary
      expansion (RME) in the volume of the right maxillary sinus, left maxillary sinus and nasal
      and maxillary sinus airway complex, through bone anchored maxillary expansion devices (BAME);
      in addition, the influence of gender and age in the volume changes will be also analyzed.
      Material and method: 18 patients between undergone RME treatment with a jackscrew based on 4
      miniscrews which will be placed in the palate on both sides of the midpalatal suture.
      Cone-beam computed tomography (CBCT) scans will be taken before and after suture palatine
      expansion and datasets will be uploaded into therapeutic digital planning software to measure
      the volume (mm3) of the right maxillary sinus, left maxillary sinus (mm3) and nasal and
      maxillary sinus airway complex (mm3). The airway volumes will be isolated after selecting the
      anatomical area in the axial, coronal and sagittal space plane and ensuring the air density
      measurement by reference points placement inside the selected area. Statistical analysis
      between preoperative and postoperative measurements will be performed using the statistical
      analysis of the t-test.
    


Intervention name(s): Rapid Maxillary Expansion
Intervention type(s): Procedure
Intervention description(s): Rapid Maxillary Expansion consists in the mid palatal suture opening through temporary anchorage mini implants placed in the palatal area.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        dental clinic patients
Efficacy and Safety of Four Escalating Dose Regimens of TPI ASM8 in Patients With Allergic Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      During this proposed clinical trial, the investigators intend to evaluate the pharmacodynamic
      anti-inflammatory properties and safety of TPI ASM8, by investigating the effect on sputum
      eosinophils and the airway responses during an allergen challenge at different dose levels.
    

Detailed description: 
      The early and late asthmatic response were both significantly attenuated by the highest dose
      of ASM8. The methacholine challenge and other parameters (ECP, mRNA knockdown on CCR3 and
      B-Chain of IL-3-Il-5 and GMCSF were attenuated by ASM8.
    

Intervention name(s): TPI ASM8; TPI ASM8; TPI ASM8; TPI ASM8
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 4 mg/mL, 1 mg BID for 4 days; 4 mg/mL, 2 mg BID for 4 days; 4 mg/mL, 4 mg BID for 4 days; 4 mg/mL, 8 mg OD for 4 days
Other intervention name(s): ASM8; ASM8; ASM8; ASM8
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children
Condition: Hand-foot-mouth Disease; Infection; Viral, Enterovirus
MeSH terms: Enterovirus Infections; Hand, Foot and Mouth Disease; Virus Diseases; Mouth Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I clinical trialto evaluate the safety of an Inactivated Enterovirus Type 71 Vaccine
      in healthy children (3-11y) and infants (6-35m).
    

Detailed description: 
      36 eligible children aged from 3 to 11 years and 96 eligible infants aged from 6 to 35 months
      will be enrolled in the study, they will be randomized to receive different dosage of vaccine
      candidate or placebo to evaluate the safety of this vaccine
    

Intervention name(s): 100U inactivated Enterovirus Type 71 Vaccine; 200U inactivated Enterovirus Type 71 Vaccine; 400U inactivated Enterovirus Type 71 Vaccine; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Inactivated Enterovirus Type 71 Vaccine, 100U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm; Inactivated Enterovirus Type 71 Vaccine, 200U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm; Inactivated Enterovirus Type 71 Vaccine, 400U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm; Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Other intervention name(s): EV71 vaccine; EV71 vaccine; EV71 vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Water Exercise and Vascular Function in Elderly
Condition: Elderly Women
Study type: Interventional

Summary: 
      Objectives:

      The purpose of this research was to assess modifications caused by a concurrent water
      exercise program on plasma nitrite (NO3), cerebral vascular resistance and cholesterol in the
      elderly and analyze the correlations between these variables after intervention.

      Methods The sample was composed of 40 women mean age 69,21 ±5,27 years old, divided into an
      intervention (WG) and control group (CG). It was to measure nitrite concentration (NO3) by
      the Griess reaction; internal cerebral arteries were assessed by Doppler ultrasound to
      determine the resistivity index and Cholesterol was determined using the colorimetric
      enzymatic method and test kit. Intervention with water exercise program consisted of three
      weekly sessions for 16 weeks.
    


Intervention name(s): Exercise; Educational lectures
Intervention type(s): Other; Other
Intervention description(s): The WG was submitted to a 16-week WEP, with combined aerobic and resistance exercises in three weekly sessions. Water temperature was approximately 30º C with an average ambient temperature of 34° C. The pool had water levels ranging between 1,20 and 1,40 meters deep.; Educational lectures
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Suprascapular Nerve Block Guided by Ultrasound
Condition: Rotator Cuff Syndrome
MeSH terms: Syndrome; Rotator Cuff Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of suprascapular nerve block guided by
      ultrasound combined with home exercises compared with placebo. Pain intensity, function,
      pressure pain threshold and goniometry were designed to be assessed in all patients.
    

Detailed description: 
      The trial is being carried out in the Institute of Physical Medicine and Rehabilitation of
      the University of São Paulo since June 2013. The investigators are including patients with
      clinical diagnosis of supraspinatus tendinitis based on the Lateral Jobe Test.

      The patients are being randomized in two arms: Active (2% 5ml lidocaine for suprascapular
      nerve block and home exercises) and placebo control (saline solution as the nerve block and
      home exercises). The randomization is being performed in blocks of 4 and 6.

      The investigator, the raters, the MD who makes the procedure and the patients are blind to
      treatment.

      4 visits are being performed. Screening and initial evaluation visit, procedure visit, follow
      up 1 week after intervention and follow up 12 weeks after intervention.

      The sample size was estimated to be 54 in each arm.
    

Intervention name(s): Lidocaine; Saline solution; Homemade exercises
Intervention type(s): Procedure; Procedure; Other
Intervention description(s): Suprascapular Nerve Block Guided by Ultrasound with 5ml lidocaine at 2%.; Suprascapular Nerve Block Guided by Ultrasound with 5ml saline solution; Codman and Hughston exercises.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rotator cuff syndrome; supraspinatus tendonitis; suprascapular nerve block; ultrasound guided; supraspinatus
S-1 Concurrent With Radiotherapy Versus Radiotherapy for Elderly Patients With Esophageal Cancer
Condition: Esophageal Cancer; Chemoradiation
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a randomised, multicenter, phase 3 trial. Patients who were age of 70 years or older
      with histologically confirmed esophageal cancer were randomly assigned to S-1 concurrent with
      radiotherapy or radiotherapy alone.The primary endpoint was overall survival.
    


Intervention name(s): Radiotherapy 54 Gy; Radiotherapy 60 Gy; S-1
Intervention type(s): Radiation; Radiation; Drug
Intervention description(s): Radiotherapy was administered in 1.8 Gy fractions 5 times weekly to a total dose of 54 Gy.; Radiotherapy was administered in 2 Gy fractions 5 times weekly to a total dose of 60Gy.; S-1 70mg/m2 was administered on days 1-14 and 29-42.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cytokines Supplementation to Culture Media and ICSI Outcome
Condition: ICSI
Study type: Interventional

Summary: 
      A randomized clinical trial to evaluate the effect of cytokine supplementation in embryo
      culture medium with various protein concentrations aiming to evaluate the effects of
      cytokines (CYK) integration into the human in vitro culture medium with high and low human
      serum albumin (HSA) concentrations on live birth rates after intracytoplasmic sperm injection
      (ICSI).
    

Detailed description: 
      Oocytes were injected, and embryos cultured and transferred in three supplemented culture
      media.

      A- A single step culture medium (SSCM; Global, Life Global)+5mg/ml (10% Vol/Vol), life global
      protein, without supplementation of CYK (control n=200), B- A single step culture medium
      (SSCM; Global, Life Global)+5mg/ml (10% Vol/Vol), life global protein, with 2ng/mL GM-CSF
      (granulocyte macrophage colony stimulating factor) (G5035 Sigma), 5ng/mL HB-EGF (Heparine
      Binding Epidermal Growth Factor )(E4643 Sigma),and 5ng/mL LIF (Lukemia Inhbitory Factor)
      (SRP9001 Sigma)(n=200).

      C- A single step culture medium (SSCM; Global, Life Global) +2mg/ml (5% Vol/Vol) life global
      protein, with 2ng/mL GM-CSF (G5035 Sigma), 5ng/mL HB-EGF (E4643 Sigma), and 5ng/mL LIF
      (SRP9001 Sigma).(n=200) Setting :- - Mansoura Integrated Fertility
    

Intervention name(s): A single step culture medium
Intervention type(s): Combination Product
Intervention description(s): A single step culture medium (SSCM; Global, Life Global)+5mg/ml life global protein, without supplementation of CYK
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicenter, randomized, double-blinded and prospective study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Buspirone for Early Satiety and Symptoms of Gastroparesis
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates whether the study medication, buspirone, an antianxiety drug, improves
      the symptoms of gastroparesis in patients with gastroparesis symptoms and at least moderately
      severe symptoms of fullness and/or inability to eat a full meal. Half the patients will
      receive buspirone and half the patients will receive a placebo.
    

Detailed description: 
      This is a multi-center, randomized, double-masked, placebo-controlled, parallel treatment
      groups phase 2 trial to determine the effect of buspirone, a 5-hydroxytryptamine (5-HT) 1a
      receptor agonist, on early satiety and postprandial fullness in participants with symptoms of
      gastroparesis and with at least moderately severe symptoms of early satiety and/or
      postprandial fullness. After enrollment, participants aged 18-75 years will be treated with
      buspirone (10 mg three times per day) or a matching placebo for 4 weeks, followed by a 2-week
      post-treatment washout period. The primary outcome for the study is 4-week change (week 4
      minus baseline) in the 4-item postprandial fullness/early satiety subscore (higher scores
      indicate worse symptoms) from the Patient Assessment of Gastrointestinal Disorders Symptom
      Severity Index (PAGI-SYM) Gastroparesis Cardinal Symptom Index (GCSI). We hypothesize that
      buspirone treatment will improve symptoms of postprandial fullness/early satiety compared to
      treatment with placebo, as indicated by a lower (smaller, more negative) 4-week change in the
      postprandial fullness/early satiety subscore in the buspirone arm compared to the placebo
      arm; change for a participant will be calculated as subscore at 4-weeks minus subscore at
      baseline.
    

Intervention name(s): Buspirone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Buspirone tablet; "Sugar" pill manufactured to mimic buspirone 10 mg tablet
Other intervention name(s): Buspar; buspirone hydrochloride (HCl); Buspar Dividose; Vanspar; Placebo (for buspirone)
Intervention MeSH terms: Buspirone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: BESST is a multi-center, randomized, placebo-controlled, double-masked, parallel treatment groups phase 2 trial with half the participants receiving the study drug, buspirone, and half receiving the placebo.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: gastroparesis; early satiety; stomach; buspirone; 5-HT 1a receptor agonist
Application Time of Plaster-of-Paris Splint Packs Compared to Bulk Supplies Following Standard Orthopaedic Procedure
Condition: Post-operative Time Saving Techniques
Study type: Interventional

Summary: 
      The investigators wish to perform a randomized controlled study to determine how much time
      and money is saved by orthopedic foot and ankle surgeons through the use of prepared splint
      packs compared to bulk supplies.
    

Detailed description: 
      The most expensive variable in the operating room (OR) is time. At the Faulkner hospital one
      hour of OR time costs approximately $500, exclusive of supply and personnel costs. Many
      things contribute to the amount of time a surgical procedure takes. One of these is
      application of the post surgical immobilization required of almost all orthopedic surgery
      cases. Custom molded Plaster-of-Paris splints are used for immobilization after the vast
      majority of orthopedic foot and ankle procedures. They have many advantages including exact
      fit for each patient, low cost and excellent safety profile. Traditionally these splints are
      constructed from bulk supplies at the end of surgical cases. The collection, measurement and
      organization of the component materials require the circulating nurse or surgeon to devote
      time to these tasks. This necessarily precludes OR staff from performing other tasks in the
      OR and lengthens the overall case duration. By lengthening the duration of the case more cost
      is incurred. The total number of cases able to be completed in a single operative day may
      also be diminished by the aggregate increased case time. Recently, the investigators have
      started utilizing prepared splint packs containing all components necessary for single
      plaster-of-Paris splint applications. This alternative to the traditional method of splint
      application has minimal expense over that incurred with traditional methods. Pilot studies
      have shown that the use of these splint packs diminish the time of application by 50 percent.
    

Intervention name(s): Pre-prepared Splint Pack composed by Medline; Bulk splint supplies
Intervention type(s): Device; Device
Intervention description(s): Applying splint by using pre-prepared splint pack; Applying splint by using the bulk splint supplies
Other intervention name(s): Standard supplies used to create post-op splint
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Health Services Research