bioihbjkbjnl/mcl2 huggingface dataset:
A Randomized Pilot Study to Evaluate the Effects of a Short Course of Metformin Versus No Therapy in the Period Prior to Hysterectomy for Grade 1-2 Adenocarcinoma of the Endometrium in Obese Non-Diabetic Women
Condition: Adenocarcinoma of the Endometrium
MeSH terms: Adenocarcinoma; Uterine Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research is to determine the effects of Metformin, a well tolerated drug
      widely prescribed for treatment of Type 2 Diabetes Mellitus, on endometrium cancer patients.
    


Intervention name(s): Metformin
Intervention type(s): Drug
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Persistence of Immune Response After Vaccination With MCC
Condition: Prevention of Meningococcal Infection
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Persistence of Immune response after vaccination with MCC
    


Intervention name(s): BLOOD DRAW
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention of Meningococcal Meningitis; vaccines; conjugate; immunology; antibody persistence
Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™
Condition: Tetanus; Poliomyelitis; Haemophilus Influenzae Type b; Acellular Pertussis; Diphtheria; Hepatitis B; Diphtheria-Tetanus-aPertussis-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
MeSH terms: Influenza, Human; Hepatitis B; Tetanus; Diphtheria; Poliomyelitis; Tetany
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to assess antibody persistence in infants who received three doses
      of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11
      months of age in study NCT00307034.
    


Intervention name(s): Blood Sampling
Intervention type(s): Procedure
Intervention description(s): A blood sample will be taken at 5 years of age, after vaccination in the primary study.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Infanrix-IPV/Hib; Long-term follow up; Persistence; Infanrix hexa
Analgesic Efficacy After Umbilical Hernia Repair in Children
Condition: Umbilical Hernia
MeSH terms: Hernia, Umbilical; Hernia
Study type: Interventional

Summary: 
      Umbilical hernia repair is a common painful outpatient procedure performed in children. Often
      analgesia for this procedure is provided by using local infiltration of the surgical site by
      the surgeons and perioperative opioids and NSAIDS both IV and orally. The use of opioids can
      cause adverse side effects which include, but are not limited to nausea, vomiting, itching,
      and respiratory depression, etc. The rectus sheath block can be performed in these patients
      to decrease their post operative pain.
    

Detailed description: 
      Umbilical hernia repair, a common Day Surgery procedure in children, is associated with
      considerable postoperative discomfort. The patient has to meet certain discharge criteria
      such as tolerating liquids, adequate level of analgesia, etc., prior to being discharged from
      the day surgery unit.

      Currently, both rectus sheath block and local infiltration of the surgical site are used for
      providing post-operative analgesia for umbilical hernia repair surgery. The local
      infiltration can only be done at the end of the surgical procedure as it could alter the
      planes of the surgical field if performed preoperatively. We believe that the analgesia
      provided prior to the surgical incision will decrease the amount of intraoperative and
      postoperative opioids used and the subsequent side effects of these medications (5,6). The
      rectus sheath block, a regional anesthetic technique, offers possible improved pain
      management following umbilical hernia repair in a recent observational study (1-3,7). We will
      perform a double-blinded, randomized study to compare the efficacy of rectus sheath block and
      surgical infiltration in providing postoperative analgesia.
    

Intervention name(s): Bupivacaine
Intervention type(s): Drug
Intervention description(s): Bupivacaine, 0.25%, dose amount is weight based, injection is divided per dise with rectus sheath injection or with local infiltration of the operative area.
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rectus Sheath; Local infiltration; Pain Control
The Effect of Erector Spinae Block on Diaphragma Movement
Condition: Laparoscopic Cholecystectomy; Acute Post-operative Pain; Respiratory Diaphragm
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Laparoscopic cholecystectomy surgeries cause moderate/severe pain and thus can result in
      shallow breathing, atelectasis and increased opioid consumption in the early postoperative
      period which in turn cause a longer hospital stay. Erector spinae plane block has been shown
      to decrease lower thoracic pain after laparoscopic cholecystectomy surgeries. This study aims
      to investigate the effect of erector spinae plane block on opioid consumption and diaphragma
      movement after laparoscopic cholecystectomy surgeries.
    


Intervention name(s): Erector spinae plane block
Intervention type(s): Procedure
Intervention description(s): Bilateral erector spinae plane block will be performed preoperatively under ultrasound guidance using 15 ml bupivacaine on each side
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
CKD-828 (80/5mg) Pharmacokinetic Study
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, single-dose, two-period, two-way, crossover study to compare the
      pharmacokinetics and safety CKD-828 (Fixed Dose Combination Tablet) to coadministration
      telmisartan and s-amlodipine in health volunteers.
    


Intervention name(s): CKD-828; Telmisartan; S-amlodipine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Telmisartan 80mg /S-Amlodipine 5mg(FDC) Tablet, Oral, Once Daily; - Telmisartan 80mg tablet, Oral, Once Daily (Combination Therapy with S-amlodipine); - S-amlodipine 5mg tablet, Oral, Once Daily (combination Therapy with Telmisartan)
Other intervention name(s): Telminuvo; Micardis; Anydipine s
Intervention MeSH terms: Amlodipine; Telmisartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; CKD-828; Telmisartan; S-amlodipine; Pharmacokinetic
Effect of Vitamin D Supplementation on Metabolic Parameters of Patients With Psoriasis
Condition: Psoriasis; Metabolic Syndrome; Vitamin D Deficiency
MeSH terms: Psoriasis; Metabolic Syndrome; Vitamin D Deficiency
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether supplementation with oral vitamin D
      (cholecalciferol) improves metabolic parameters in patients with moderate to severe
      psoriasis.
    


Intervention name(s): Vitamin D3; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A daily 5.000 IU vitamin D3 capsule during 6 weeks.; A daily placebo capsule during 6 weeks.
Other intervention name(s): Cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psoriasis; Vitamin D; Metabolic syndrome; Insulin resistance; Cholesterol; Methotrexate; Dyslipidemia; PASI; Psoriasis Area Severity Index
Randomised Controlled Study on the Use of Psychoeducation for Bulimia Nervosa in Young Women
Condition: Bulimia Nervosa
MeSH terms: Bulimia; Bulimia Nervosa
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectivity of guided self-help via Internet and
      bibliotherapy in the treatment of bulimia nervosa (BN) in young women.
    

Detailed description: 
      Eating disorders and especially bulimia nervosa are psychiatric diseases, affecting 2-4% of
      women. An intervention such as guided self-help via manuals (bibliotherapy) is a well
      accepted approach and accepted. Development of new technologies in recent years allows
      delivery of psychotherapy via CD-ROMs and web-based interfaces. These new technologies have
      not yet been implemented in Austria in treating bulimia nervosa (BN) patients. In particular
      patients will be involved, who would not attend medical care regularly. The aim of our study
      is therefore to deliver guided self-help via an internet platform (supported by email
      contacts) for 100 patients with BN and to investigate the practicability and effectivity of
      this approach as well as compliance of patients in this group.

      Patients will be found and contacted via internet, get specialized medical investigations,
      medical care and support via emails. As control group 100 patients with bulimia are treated
      with bibliotherapy only. Beside effectivity, predictors of outcome (clinical, comorbidity,
      indication to change, personality) are investigated.

      The proposed study is a randomised controlled trial for effectivity and practicability of new
      technologies in psychiatric treatment research.

      This is not a psychotherapy study but a study on psychoeducation, an approach which offers
      new and helpful opportunities for this patient group.
    

Intervention name(s): Guided Self-help for Bulimia nervosa
Intervention type(s): Behavioral
Intervention description(s): bibliotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bulimia nervosa; Guided Self-help; Psycho-education
Evaluation of Smectite Effect As A Food Thickener On Gastroesophageal Reflux Disease In Neonates Using Combined Esophageal Multichannel Intraluminal Impedance
Condition: Gastroesophageal Reflux in Neonates
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 4

Summary: 
      study of diagnosis of GERD in neonates by MII-PH with trial of smectite for treatment
    

Detailed description: 
      This is a prospective clinical trial conducted on 20 preterm neonates < 37 weeks of
      gestation, admitted in NICU, maternity hospital, Ain Shams University. They were assessed for
      gastroesophageal reflux disease and investigated using ph-MII for detection of reflux
      episodes and they were given Smecta 3gm/day for 7 days at least as a food thickener and then
      ph-MII repeated to assess the response
    

Intervention name(s): Diosmectite
Intervention type(s): Drug
Intervention description(s): use of diosmectite as a food thickener in neonates in with gastroesophageal reflux in noenates
Other intervention name(s): Smecta
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
RSV-F Vaccine Dose Ranging Study in Young Women
Condition: Respiratory Syncytial Virus (RSV)
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the immunogenicty and safety of an RSV-F protein
      nanoparticle vaccine, with out without aluminum, in healthy women of child-bearing potential.
    


Intervention name(s): Low dose RSV-F Vaccine with Adjuvant; Low dose RSV-F Vaccine without Adjuvant; High dose RSV-F Vaccine with Adjuvant; High dose RSV-F Vaccine without Adjuvant; Low dose RSV-F Vaccine with Adjuvant [Bedside Mixing]; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5mL IM Injection; 0.5ml IM Injection; 0.5mL IM Injection; 0.5mL IM Injection; 0.5mL IM Injection; 0.5mL IM Injection
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
23-gauge Pars Plana Vitrectomy With Silicone Oil Injectionsilicone Oil Injection With Surgical
Condition: Retinal Detachment
MeSH terms: Retinal Detachment
Study type: Interventional

Summary: 
      Objective: to evaluate anatomical and visual outcomes of 23-gauge vitrectomy for retinal
      detachment with silicone oil injection in fifty cases. The rate of recurrence, the incidence
      of proliferative vitreoretinopathy (PVR) and the value of risk factors.

      Participants and Methods: fifty cases with RD with mixture of epiretinal and subretinal
      membranes were collected. Pars plan vitrectomy, 23gauge vitrectomy were done to these cases,
      then silicone oil removed 6 weeks after primary surgery.

      Main Outcome Measures: The anatomical success rate,the failure rate ,the rate of retinal
      breaks in both groups, and reproliferation rate.
    

Detailed description: 
      50 Patients were included if they had retinal detachment, moderate degrees of PVR, PVR ≥
      Grade C, previous buckle surgery and pseudophakia. A good and correct assessment of the
      detached retina was done. Investigator followed the Lincoff rules to find the retinal breaks.
      Investigator performed a three-port vitrectomy: one infusion trocar and two instruments
      trocars. Non-contact wide-angle viewing systems (Resight- Biom) have a viewing field of
      60-130° was used. Investigator used Perfluorocarbon liquid (PFCL) for attaching the retina
      with its gravity. Then performing PFCL against air exchange.The retina will be attached under
      air tamponade. Laser photocoagulation was performed in the air-filled eye.

      Investigator applied the laser effects confluently surrounding all retinal breaks. Then
      silicone oil (1000 centistokes) was injected as a final step and permanent tamponade.After
      3-6 months investigator removed the silicone and examined the retina for 6 weeks after
      surgery to detect the recurrent cases.
    

Intervention name(s): 23 PARS PLANA VITRECTOMY
Intervention type(s): Procedure
Intervention description(s): We performed a three-port vitrectomy: one infusion trocar and two instruments trocars. Non-contact wide-angle viewing systems (Resight- Biom) have a viewing field of 60-130° was used. Put 23 needle attached to the automated pump for silicone oil extraction. Strict examination of the retina to detect new breaks or untreated breaks. Closure of the sclerotomies.
Other intervention name(s): SILICONE OIL REMOVAL
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Fifty participants were assigned and divided into two groups. Participants without RD after SO removal was recruited into group A-NRD, and participants with RD after SO removal was recruited into group B-RD.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: retina; silicone; laser; break; vitrectomy
PCORI-CER-1306-03385 Informed Decisions About Lung Cancer Screening
Condition: Lung Cancer; Smoking Cessation; Tobacco Use Cessation
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      Educational research study where goal is to test educational materials that help people make
      informed decisions about lung cancer screening.
    

Detailed description: 
      This is the second phase of a larger project funded by the Patient-Centered Outcomes Research
      Institute to help heavy smokers make informed decisions about lung cancer screening with
      low-dose computed tomography (LDCT). The aim of this phase is to compare outcomes for
      promoting informed screening decisions about lung cancer screening in a randomized trial of
      patients who smoke recruited through state-based smoking cessation quitlines, where patients
      will be randomly assigned to the updated patient decision aid or to standard educational
      materials on lung cancer screening.
    

Intervention name(s): Patient Decision Aid; Standard Educational Information; Follow-Up Assessments: Questionnaires
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will receive study materials including a video to watch about lung cancer screening; Participants will receive study materials including a booklet to read about lung cancer screening.; Follow up questions administered via phone and/or mail at 1-week, 3-month, and 6-month
Other intervention name(s): Video; DVD; Booklet; Survey
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Lung Cancer Screening; heavy smokers; state-based smoking cessation quitlines; patient decision aid; low-dose computed tomography; LDCT; standard educational information
Adjunctive Photodynamic Therapy in Treatment of Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to verify the efficacy of Photodynamic Therapy (PDT) as an adjunct
      to non-surgical treatment of chronic periodontitis by assessing clinical and microbiological
      and immunological parameters. This is a randomized, controlled, double-blind, parallel
      clinical trial. Thirty eight patients with chronic periodontitis will receive conventional
      periodontal treatment. After eight weeks, patients will be re-evaluated and sites with
      residual pockets (PD ≥ 5 mm ) will be selected as experimental sites, and will be allocated
      to test and control group randomly. The test group will receive the application of PDT and
      the control group will receive sham procedure. The clinical parameters will be evaluated at
      baseline, 3, 6 and 12 months after treatment. Subgingival plaque will be collected before
      PDT, a week after, 3, 6 and 12 months later. The microbiological evaluation will detect and
      quantify periodontal pathogens such as Porphyromonas gingivalis, Tannerella forsythia,
      Treponema denticola and Aggregatibacter actinomycetencomitans with real time-PCR. During
      follow-up, patients will receive periodontal maintenance every 3 months, as well as the
      application of PDT or sham
    

Detailed description: 
      The goal of periodontal treatment is to restore tissue health through the elimination and
      control of etiologic factors, reducing the microbial aggression. Some microorganisms persist
      in the root surface even after scraping. Thus, the conventional mechanical treatment may fail
      to reduce the number of periodontal pathogens to levels compatible with health. This study
      will verify the efficacy of Photodynamic Therapy (PDT) as an adjunct to non-surgical
      treatment of chronic periodontitis.
    

Intervention name(s): sham procedure; photodynamic therapy
Intervention type(s): Device; Device
Intervention description(s): non activated laser tip; photodynamic therapy 660 nm,40 mW,60 Hz
Other intervention name(s): Laser Hand - MM Optics (ANVISA: 80051420009); Laser Hand - MM Optics (ANVISA: 80051420009)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: periodontitis; photodynamic therapy
Short-term Effects of Physiotherapy on LCI
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      Although some studies have brought some evidences about the efficacy of positive expiratory
      pressure (PEP)-mask therapy as an airway clearance technique, yet it is not clearly
      understood what is the contribution of this technique in modifying peripheral ventilation
      inhomogeneity, a typical feature of patients with Cystic Fibrosis (CF).

      The aim of this study is to investigate how PEP-MASK affects ventilation inhomogeneity in
      children and adolescents, with moderate to normal CF lung disease by the change in acinar
      airways (Sacin), lung clearance index (LCI) and conductive airways (Scond) indexes derived
      from nitrogen multiple-breath washout test (N2MBW).
    

Detailed description: 
      Investigational device: PEP-MASK=Positive Expiratory Pressure delivered through a face mask.

      Standard Operating Procedures used for evaluating CF lung disease and ventilation
      inhomogeneity.

      Sample size: Based on preliminary data collected on seven subjects who performed nitrogen
      multiple-breath washout test before and after PEP-MASK, assuming a variation of 20% of Sacin,
      the study requires a sample size of 18 subjects.
    

Intervention name(s): PEP-MASK
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Cross-over randomized controlled trial. Procedure: two nitrogen multiple-breath washout tests, one before and one after the intervention with PEP-Mask, either standard or sham allocation, during two subsequent mornings.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: physiotherapy; pulmonary function