bioihbjkbjnl/mcl2 huggingface dataset:
Laparoscopic Surgery Equivalent to Open Surgery in Right Colon Cancer Surgery?
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Study type: Observational

Summary: 
      The primary goal of this study is to compare in the long-term costs of laparoscopic or open
      right colectomy in patients sustaining a colon cancer controling for the carcinologic
      equivalence of the two surgical strategies. The secondary goals to compare long-term
      mortality, morbidity as well as quality of life of the two groups.The present study is an
      prospective multicentric observational trial taking into account the usual surgical strategy
      of every centers
    

Detailed description: 
      The aim of the present study is to compare in the long-term costs of laparoscopic and open
      right cancer colectomy as well as the mortality the morbidity and the quality of life of the
      operated patients.

      The number of patients need to get a 54% power is 300. The average number of
      patients/surgical center is approximately 27 in 14 surgical centers.

      The proposed undertaking of every patient is fully identical to that which is usually
      proposed by the surgical center in charge of the patient (i.d. 7 centers will perform
      laparoscopic procedures and 7 centers open procedure according to their usual practice).

      A complete information leaflet will be given to the patients during the first consultation
      which will correspond to the enrollment day.

      The preoperative, intraoperative and postoperative period will be in complete accordance with
      the usual care of the center.

      The baseline demographics and conditions as well as the perioperative items and the
      postoperative occurrences will be recorded through a prior designed e-questionnaire.

      The follow-up encompass 5 postoperative consultations:1 month, 6 ,12 ,18 and 24 months.

      On every consultation the patient will fill a very simple validated quality of life
      questionnaire (EORTC,QLQ.C30) an give back a weekly journal reporting the potentially arising
      medical and surgical events.

      Globally the comparative analysis of the costs ,the mortality ,the morbidity, the quality of
      life ot the patients undergoing either a laparoscopic or a open right colectomy for cancer
      will be performed controling for the carcinologic equivalence of the two surgical strategies.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Right colon cancer < T4 without metastasis needing colectomy
      
Keywords: Colon Cancer Surgery; Laparoscopy; Open surgery; Costs; Mortality; Morbidity; Quality of life
Dermacyd Tina Gel Sweet Flower - Photo Evaluation
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to prove the absence of photo irritation and photo sensitivity
      potential of the product Dermacyd Tina Gel Sweet Flower.
    


Intervention name(s): Lactic acid (Dermacid)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Hygiene
Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5
      days in children with acute otitis media (AOM).

      Secondary objectives are to assess Efficacy, Pharmacokinetics and Acceptability of
      telithromycin 20 mg/kg qd for 5 days in children with AOM.
    


Intervention name(s): Telithromycin (HMR3647)
Intervention type(s): Drug
Intervention MeSH terms: Telithromycin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Otitis Media; AOM; children; Child
Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma, Kaposi; Sarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Nicotine may stimulate the immune system to kill Kaposi's sarcoma cells.

      PURPOSE: This phase II trial is studying the side effects and how well the nicotine skin
      patch works in treating patients with Kaposi's sarcoma.
    

Detailed description: 
      OBJECTIVES:

        -  Evaluate the toxicity and efficacy of transdermal nicotine applied to lesions in
           patients with classic Kaposi's Sarcoma.

      OUTLINE: This is a double-blind, placebo-controlled study.

      Patients apply a nicotine dermal patch to a selected lesion and a placebo patch to the other
      lesion, replacing the same type of fresh patch every other day, during the first 2 weeks,
      increasing the nicotine dose in week 3 and again in week 5 for a total of 15 weeks in the
      absence of disease progression or unacceptable toxicity.

      PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
    

Intervention name(s): nicotine
Intervention type(s): Drug
Intervention MeSH terms: Nicotine
Masking: Double
Primary purpose: Treatment
Keywords: classic Kaposi sarcoma; recurrent Kaposi sarcoma
Effects of a Diet Based on Inulin-rich Vegetables on Gut Health and Nutritional Behaviour in Healthy Humans
Condition: Healthy
Study type: Interventional

Summary: 
      Inulin-type fructans (ITF) are fermentable dietary fibres that can confer beneficial health
      effects through changes in the gut microbiota. However, their effect on gut sensitivity and
      nutritional behaviour is a matter of debate.

      The investigators evaluated, in healthy individuals, the impact of shifting from their usual
      food habits towards a diet based on the daily consumption of ITF-rich vegetables on gut
      microbiota, gastro-intestinal symptoms and food-related behaviour.
    


Intervention name(s): Diet based on inulin-rich vegetables
Intervention type(s): Other
Intervention description(s): During two weeks, healthy subjects were instructed to adhere to a controlled diet based on ITF-rich vegetables (±15 g ITF/day).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
NMDA-enhancing Agent for the Treatment of Mild Cognitive Impairment
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      NMDA neurotransmission plays an important role in learning and memory. NMDA receptors were
      found to decrease in the frontal lobe and hippocampus of mild cognitive impairment. This
      study is a randomized, double-blind, placebo-controlled drug trial. All subjects will be
      allocated randomly to 2 groups: (1) NMDA-enhancer: DAOIB group (starting dose: 250-500 mg/d);
      (2) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOIB may
      yield better efficacy than placebo for cognitive function in patients with mild cognitive
      impairment.
    


Intervention name(s): DAOIB; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Bioavailability and Pharmacokinetics of Vedolizumab in Healthy Participants Following Single Subcutaneous Administration
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the absolute bioavailability and pharmacokinetics of
      vedolizumab following a single injection of vedolizumab subcutaneously at 3 varying doses.
    

Detailed description: 
      The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to
      determine its bioavailability, safety, and tolerability in the body with three varying doses
      of vedolizumab SC compared to people who are administered vedolizumab IV.

      The study will enroll approximately 24 non-Japanese patients and 24 Japanese patients.
      Participants will be randomly assigned to one of the four treatment groups:

        -  Vedolizumab Intravenous 300 mg

        -  Vedolizumab Subcutaneous 54 mg

        -  Vedolizumab Subcutaneous 108 mg

        -  Vedolizumab Subcutaneous 160 mg

      All participants will receive the treatment they are assigned on Day 1 of the study.

      This single-center trial will be conducted in the United Kingdom. The overall time to
      participate in this study is up to 196 days. Participants will make 10 visits to the clinic,
      including one 8 day period of confinement to the clinic, and will be contacted by telephone
      at Study Day 168 (+/-3), approximately 6 months after dose for a follow-up questionnaire.
    

Intervention name(s): Vedolizumab SC; Vedolizumab IV
Intervention type(s): Drug; Drug
Intervention description(s): Vedolizumab injection, for subcutaneous use (vedolizumab SC); Vedolizumab injection, for intravenous use (vedolizumab IV)
Other intervention name(s): MLN0002SC; MLN0002SC
Intervention MeSH terms: Vedolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug therapy
Comparison of Desloratadine Associated With Prednisolone Oral Solution Versus Dexchlorpheniramine Associated With Betamethasone for Persistent Allergic Rhinitis Treatment
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the non-inferiority clinical efficacy of two
      different drug associations in the treatment of Moderate - Severe Persistent Allergic
      Rhinitis.
    

Detailed description: 
      -  double-blind, non-inferiority, prospective, parallel group trial.

        -  Experiment duration: 07 days.

        -  02 visits (days 0 and 7).

        -  Efficacy will be evaluated for persistent allergic rhinitis based on nasal symptoms
           score

        -  Adverse events evaluation.
    

Intervention name(s): Dexchlorpheniramine + Betamethasone; Desloratadine + Prednisolone
Intervention type(s): Drug; Drug
Intervention description(s): Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day; Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day
Intervention MeSH terms: Prednisolone; Betamethasone; Desloratadine; Dexchlorpheniramine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparative Efficacy of Ovule vs Tablet
Condition: Clotrimazole; Ovulen; Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is focused to prove that the efficacy of a new Canesten formulation (ovule) is not
      inferior to the old Canesten formulation (tablet)
    


Intervention name(s): Clotrimazole, vaginal ovule; Clotrimazole, vaginal tablet
Intervention type(s): Drug; Drug
Intervention description(s): Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).; Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).
Intervention MeSH terms: Clotrimazole; Miconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Clotrimazole; Ovule; Tablet; Vulvovaginal candidiasis; Non-inferiority
Discordance of Obesity in Adolescent Sibilngs
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      This research studies the energy balance behaviors (usual eating, physical activity,
      sedentary) and non-shared experiences of siblings discordant for weight (one sibling is lean
      the other is overweight).
    

Detailed description: 
      This research studies the energy balance behaviors (usual eating, physical activity,
      sedentary) and non-shared experiences of siblings discordant for weight (one sibling is lean
      the other is overweight). To accomplish this, siblings attend four laboratory sessions where
      they consume one of two types of kool-aid, smell the pizza, or rest quietly. Siblings then
      eat a dinner meal. Siblings also wear an activity monitor for one week and record their
      physical activity and sedentary activities in a habit book.
    

Intervention name(s): Kool-aid
Intervention type(s): Other
Intervention description(s): Participant drank two different types of kool-aid (sugar free and regular)
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Forty-eight sibling pairs (24 pairs of boys and 24 pairs of girls, 96 total adolescents)
        age 13 to 17 years who are discordant for overweight/obesity will be studied to assess
        potentially modifiable non-shared experiences within and outside the family environment
        that alter energy balance behaviors and contribute to adolescent overweight. We will also
        measure the height and weight of up to 3 of their best friends.
      
Keywords: siblings; overweight; adolescent
A Study to Assess the Bioequivalence of Dapagliflozin/Metformin XR Fixed-dose Combination Tablets in Healthy Subjects
Condition: Bioequivalence; Fixed Dose Combination Tablets; Healthy Male and Female Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a bioequivalence study to compare 2 fixed-dose combination tablets of
      dapagliflozin/metformin XR manufactured at 2 different plants in healthy subjects under
      fasting and fed conditions
    

Detailed description: 
      This is a Phase 1, 2-part, open-label, randomized, 4-period, 4-treatment, crossover study in
      healthy subjects (males and females of non-childbearing potential)
    

Intervention name(s): dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon); dapagliflozin/metformin XR 5/500 mg reference drug (Humacao); dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon); dapagliflozin/metformin XR 10/1000 mg reference drug (Humacao)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single fixed-combination dose tablets; single fixed-dose combination tablets; single fixed-dose combination tablets; single fixed-dose combination tablets
Intervention MeSH terms: Metformin; Dapagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: dapagliflozin/metformin XR 5/500 mg; dapagliflozin/metformin XR10/1000 mg; bioequivalence; fixed dose combination tablets; pharmacokinetic; type 2 Diabetes Mellitus (T2DM); safety
Comparison of Different Video Laryngoscopes in < 1 Year Old Undergoing Neurosurgical Operations: a Prospective Randomized Study
Condition: Intubation;Difficult
Study type: Interventional

Summary: 
      İntubation of pediatric patients is a challenging problem. Video laryngoscopes increased the
      intubation success rate. We want to compare different video laryngoscopes in this field.
    

Detailed description: 
      Aim:İntubation of pediatric patients is a challenging problem. Video laryngoscopes increased
      the intubation success rate. We want to compare different video laryngoscopes in this field.

      methods: We enroll total 50 patients < 1 year old undergoing neurosurgery. We compared the
      intubation times, success rates and minor complications of Airtraq and c-mac video
      laryngoscopes in these pediatric patients undergoing neurosurgery.
    

Intervention name(s): airtraq; c-mac
Intervention type(s): Device; Device
Intervention description(s): device entering the oral cavity till visualization of the endotracheal tube entering the vocal cords; device entering the oral cavity till visualization of the endotracheal tube entering the vocal cords
Other intervention name(s): videolaryngoscope; videolaryngoscope
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: airtraq; c-mac; videolaryngoscope; infant; intubatioon
The Evaluation of the Deepithelialized Gingival Graft Healing
Condition: Wound Heal
Study type: Interventional

Summary: 
      The aim of this study was to compare of the effects of different fixation methods on
      deepithelialized gingival graft wound healing. Laser doppler flowmetry method was used to
      determine for blood perfusion changes. 40 patients were devided into two groups randomly and
      deepithelialized gingival graft procedure was performed and healings were evaluated by laser
      doppler flowmetry.
    

Detailed description: 
      This study evaluates the effects of different fixation methods on the early healing period of
      deepithelialized gingival grafts placed for non-root coverage gingival augmentation by laser
      Doppler flowmetry Forty patients were assigned to study groups: 1)test : tissue adhesive or
      2) control group: suture. Forty patients completed the study. Blood perfusion in the
      recipient site was measured by laser doppler flowmetry on the day of surgery and at 3 and 7
      days after surgery. Quality of life and pain at recipient sites were also investigated.
    

Intervention name(s): deepithelialized gingival graft fixation
Intervention type(s): Procedure
Intervention description(s): one group's deepithelialized gingival graft fixed by sutures and other one's by tissue adhesive.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Placebo-Controlled Study of ONO-2333Ms in Patients With Recurrent Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of ONO-2333Ms in patients
      with Recurrent Major Depressive Disorder
    


Intervention name(s): ONO-2333Ms Experimental 2; Placebo; ONO-2333Ms Experimental 1
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5-10 mg QD(once a day) for 8 weeks; 0 mg QD(once a day) for 8 weeks; 1-2 mg QD(once a day) for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ONO-2333Ms; Major Depressive Disorder
A Single Center, Open-Label Study to Quantify Metabolites of [14C]-Neramexane in Plasma and Urine in Healthy Male Subjects
Condition: Metabolism of Neramexane
Study type: Interventional
Phase: Phase 1

Summary: 
      A Single Center, Open-Label Study to quantify metabolites of [14C]-Neramexane in plasma and
      urine in Healthy Male Subjects
    


Intervention name(s): Neramexane
Intervention type(s): Drug
Intervention description(s): Multiple dose Neramexane followed by single dose 14C Neramexane
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy and Safety of Milrinone Versus Sildenafil in the Treatment of Neonates With Persistent Pulmonary Hypertension
Condition: Persistent Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      Compare the effect of milrinone versus sildenafil in treatment of neonates with persistent
      pulmonary hypertension.
    

Detailed description: 
      40 neonates with PPHN, met inclusion criteria, randomly assigned to 2 groups, each includes
      20, first group received intravenous milrinone and second group received nasogastric
      sildenafil. both groups receive other supportive care.
    

Intervention name(s): Milrinone; Sildenafil
Intervention type(s): Drug; Drug
Intervention description(s): milrinone lactate, 1mg/ml, for intra venous use only; 50mg sildenafil citrate/tablet, crushed in water taken by nasogastric tube
Other intervention name(s): primacor; Viagra
Intervention MeSH terms: Milrinone; Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Asthma & Exposure to Peaks in Particulate Air Pollution
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      We are testing the following two hypotheses: 1) Peaks in hourly exposures to airborne
      particulate matter (PM) of outdoor origin will be more closely associated with acute
      asthmatic responses to particles than 24-hour average exposures in susceptible individuals;
      2) Personal exposure to PM, and estimated particle dose to the lungs, will be more closely
      associated with daily asthma severity than standard outdoor particle concentrations measured
      as 24-hour averages at governmental monitoring sites.
    

Detailed description: 
      We are testing the following two hypotheses: 1) Peaks in hourly exposures to airborne
      particulate matter (PM) of outdoor origin will be more closely associated with acute
      asthmatic responses to particles than 24-hour average exposures in susceptible individuals;
      2) Personal exposure to PM, and estimated particle dose to the lungs, will be more closely
      associated with daily asthma severity than standard outdoor particle concentrations measured
      as 24-hour averages at governmental monitoring sites. Toxicological data for asthma
      exacerbations from particulate matter (PM) suggests that particle deposition in the lower
      respiratory tract can cause inflammatory and lung function changes suggestive of asthma
      pathology. There is now a scientific need to explain epidemiological findings of ambient PM
      effects on asthmatics at mass concentrations below what is expected (from toxicological data)
      to be harmful. One possibility is that study participants are encountering unmeasured
      short-term excursions of particle mass levels capable of inducing adverse reactions in the
      lung, but this effect is only captured somewhat by the regulatory standard of 24-hour
      averages. Our research in southern California is vital to the current controversy regarding
      regulatory standards given that a health-based scientific rationale for any specific PM
      averaging time is not established.
    

Observational model: Defined Population
Time perspective: Prospective
Keywords: asthma; particulate matter
Evaluation of Efficay & Safety of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-2 Study
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The main purpose of this study is to evaluate the efficacy and safety of the study drug known
      as galcanezumab in participants with episodic migraine.
    


Intervention name(s): Galcanezumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): LY2951742
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: prevention; prophylaxis; headache