bioihbjkbjnl/mcl2 huggingface dataset:
Electrohaemodynamic Activity in Epileptic Children : Combined Video-EEG and Near-infrared Spectroscopy (NIRS) Analysis
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Observational

Summary: 
      Evaluate the contribution of multimodal high-resolution EEG-NIRS electrical and local
      haemodynamic analysis to spatial localization of epileptogenic foci
    

Detailed description: 
      This study is designed to evaluate the contribution of multimodal high-resolution EEG-NIRS
      electrical and local haemodynamic analysis (HR-EEG, HR-NIRS) to spatial localization of
      epileptogenic foci in order to perform multimodal mapping and localization of interictal
      spikes (by HR-EEG source reconstruction) with the clinical prospects of guiding the SEEG
      electrode implantation strategy prior to surgery in children with drug-refractory partial
      epilepsy.
    

Intervention name(s): multimodal high-resolution EEG-NIRS
Intervention type(s): Device
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children between the ages of 6 and 18 years with drug-refractory partial epilepsy,
        presenting interictal spikes on standard EEG recordings.
      
Keywords: Video-EEG; near-infrared spectroscopy (NIRS)
Treatment of Bacterial Vaginosis in Early Pregnancy in Skaraborg and the Effect on Spontaneous Preterm Delivery
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases; Premature Birth
Study type: Observational

Summary: 
      Bacterial vaginosis (BV) is a known risk factor for preterm delivery. This study was
      conducted in an attempt to investigate if treatment of bacterial vaginosis in early pregnancy
      could reduce the risk for preterm delivery.

      Women were screened for bacterial vaginosis during the first visits at the maternal health
      care unit with a vaginal sample that were taken by the midwife or by herself. After the
      vaginal samples was air dried it was sent to the gynaecological department and was
      investigated using Hay/Ison classification. Eligible women were those who had lived in
      Skaraborg and delivered at Skaraborg hospital.
    

Detailed description: 
      The study has started 2007 and will continue until 2014. Pregnant women that will come to the
      maternal health care units in gestational week 8-11 will be offered to be screened for
      bacterial vaginosis. A vaginal sample will be taken by the midwife or by the women herself.
      The vaginal sample is air-dried and sent to the gynecological. There it is investigated using
      Hay/Ison classification for the diagnosis of bacterial vaginosis.

      Women with bacterial vaginosis will be offered treatment with topical clindamycin treatment
      for 7 days if the women has passed the 12th gestational week. A control sample for the test
      of cure will be done after 10 week. If not cured of BV she will be offered a new treatment.

      All women will be followed until delivery.
    

Intervention name(s): Clindamycin-2-phosphate
Intervention type(s): Drug
Intervention description(s): how many women will deliver before the 37th week of gestation
Other intervention name(s): Dalacin vaginal cream
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant women with bacterial vaginosis in early pregnancy
Epidemiological Analysis for Hereditary Angioedema Disease
Condition: Abdominal Pain; Functional Abdominal Pain
MeSH terms: Angioedema; Angioedemas, Hereditary; Abdominal Pain
Study type: Observational

Summary: 
      An international, multicenter, epidemiological, observational study investigating the
      prevalence of Hereditary Angioedema (HAE) disease among participants with recurrent episodes
      of abdominal pain of no obvious etiology.
    

Detailed description: 
      Hereditary Angioedema (HAE) is a rare autosomal dominant disorder characterized most commonly
      by deficient (type 1) or nonfunctional (type 2) C1 inhibitor protein (encoded by SERPING1
      gene). The disorder is associated with episodes of angioedema of the face, larynx, lips,
      abdomen, and extremities. The angioedema is caused by the activation of the kallikrein-kinin
      system that leads to the release of vasoactive peptides, followed by edema, which in severe
      cases can be life threatening.

      Gastrointestinal involvement occurs in 93% of patients with HAE and may be the only
      manifestation of the disease. However, individuals with gastrointestinal symptoms are rarely
      considered for HAE and the disease can be misdiagnosed for several years.

      EHA study focuses on the gastrointestinal complications of HAE as a potential area of
      misdiagnosis leading to surgical morbidity. Aim of the study is to investigate the prevalence
      of HAE among participants experiencing recurrent abdominal pain attacks with no clear
      etiology. The HAE-positive samples in the study will be further analyzed biochemically to
      identify disease-specific biomarker that may support the development of new diagnostic tools
      for HAE disease.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants with previous episodes of abdominal pain attacks of no obvious etiology
      
Biospecimen description: 
      Blood sample applied on the Dry Blood Spot (DBS) Filtercard (Centocard®)
    
Keywords: Hereditary Angioedema; DBS-based biochemical and genetic assay for HAE type I/II; Biomarker
Evaluation of the Additional Efficacy, and Safety of Olmesartan Medoxomil 20mg / Hydrochlorothiazide 12.5mg in the Treatment of Chinese Patients With Mild to Moderate Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the additional efficacy and safety of olmesartan
      medoxomil/hydrochlorothiazide in the treatment of Chinese patients with mild to moderate
      essential hypertension, who fail to attain the blood pressure goals with olmesartan medoxomil
      monotherapy
    


Intervention name(s): olmesartan medoxomil + hydrochlorothiazide; olmesartan medoxomil
Intervention type(s): Drug; Drug
Intervention description(s): olmesartan medoxomil 20mg oral tablets, once daily for 4 weeks then olmesartan medoxomil 20mg oral tablets + hydrochlorothiazide 12.5 mg oral tablets, once daily for up to 8 weeks; olmesartan medoxomil 20mg oral tablets, once daily for 4 weeks then olmesartan medoxomil 40mg oral tablets, once daily for up to 8 weeks
Intervention MeSH terms: Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Clinical Trial of CS12192 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic
      profiles of CS12192 after single or multiple oral administration, as well as the food effect
      on the pharmacokinetics in healthy subjects.
    

Detailed description: 
      This study consists of 3 parts: single ascending dose (SAD), multiple ascending dose (MAD)
      and food effect (FE). Both SAD and MAD study are randomized, double-blind, placebo-controlled
      design. The FE study use a randomized, open-label, two-period, two-crossover design.
    

Intervention name(s): CS12192 capsule; Placebo capsule
Intervention type(s): Drug; Drug
Intervention description(s): Participants receive CS12192 orally single or multiple doses; Participants receive placebo matching CS12192 orally single or multiple doses
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The study consists of 3 parts: single ascending dose (SAD), multiple ascending dose (MAD) and food effect (FE). Both SAD and MAD study use a randomized, double-blind, placebo-controlled dose-escalation design. The FE study use a randomized, open-label, two-period, two-crossover design.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: healthy
Relative Bioavailability of Single Doses of Dabigatran Etexilate When Administered Alone or in Combination With a Single Dose of Ketoconazole or in Combination With q.d. Ketoconazole at Steady State in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate whether and to what extent the P-glycoprotein (P-gp) inhibitor ketoconazole
      affects plasma exposure of dabigatran.
    


Intervention name(s): Dabigatran etexilate; Ketoconazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ketoconazole; Dabigatran
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Pre-emptive Analgesics on Post-Operative Pain After Stainless Steel Crown Placement On Primary Molars
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to evaluate the effectiveness of pre-emptive analgesia using
      ibuprofen and paracetamol on reducing post-operative pain following the placement of
      stainless steel crowns on primary molars compared to placebo
    

Detailed description: 
      The study will be a parallel, placebo-controlled, triple-blinded, randomized clinical trial.
      A total of 66 healthy children aged 5-8 years requiring the placement of a stainless steel
      crown will be selected from Pediatric Dentistry and Dental Public Health Department, Faculty
      of Dentistry, Alexandria University, Egypt. The children will be randomly allocated into
      three groups according to the type of pre-emptive solution used. Group I will receive
      ibuprofen, group II will receive paracetamol, while group III (control) will receive a
      placebo solution. Children will self-report their level of pain using a Visual analogue scale
      (VAS) and/or a Facial pain scale (FPS) after local anesthesia administration, immediately
      after the cementation of the stainless steel crown, and 2, 6 and 24 hours post-operatively.
      Children's baseline anxiety and parental anxiety will also be assessed.
    

Intervention name(s): Ibuprofen; Paracetamol; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Ibuprofen is a non-steroidal anti-inflammatory drug which acts by reducing the production of cyclo-oxygenases (COX-1 and COX-2)- derived prostanoids in the blood; Paracetamol is an analgesic that acts peripherally; although its primary site of action is still debatable, it is thought to inhibit prostaglandins in the hypothalamus; A placebo solution will be freshly prepared by an assistant in a manner to match the color and odor of the analgesics
Other intervention name(s): BRUFEN®, Kahira Pharmaceuticals & Chemical Industries Co.; CETAL®, EGYPTIAN INT. PHARMACEUTICAL INDUSTRIES CO.
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pre-emptive analgesia; ibuprofen; paracetamol; post-operative pain; stainless steel crown; Primary molars
Effect of Pycnogenol® on ADHD
Condition: ADHD
Study type: Interventional
Phase: Phase 3

Summary: 
      This double blind, randomised controlled trial examines the effect of a commercially
      available nutritional supplement on behaviour of ADHD patients, as well as on their physical
      and psychiatric co-morbidities, and level of oxidative stress and immune activity, as
      compared to placebo and standard pharmaceutical treatment for ADHD.
    


Intervention name(s): Pycnogenol; Methylphenidate; Placebo
Intervention type(s): Dietary Supplement; Drug; Other
Intervention description(s): Dietary supplement, standardised extract of French maritime Pine bark. This group receives a nutritional supplement for a period of 10 weeks.; Standard pharmaceutical treatment for ADHD, slow release.; Placebo treatment (identical capsules containing excipients only)
Intervention MeSH terms: Methylphenidate; Pycnogenols
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Using Ultrasound in Infraclavicular in Upper Limb Surgeries
Condition: Upper Limb Surgeries
Study type: Interventional

Summary: 
      Comparison of 3 approach of infraclavicular brachial plexus
    

Detailed description: 
      Comparison of retroclavicular & costoclavicular and classic type of infraclavicular brachial
      plexus block for upper limb surgeries
    

Intervention name(s): Infraclavicular brachial plexus block
Intervention type(s): Procedure
Intervention description(s): Using ultrasound in 3different techniques of infraclavicular brachial plexus block
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Trial of a Novel Brief Intervention on Health Behaviors for Youth With Chronic Medical Conditions
Condition: Substance Use
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The primary goal of this project is to develop a tailored screening, brief intervention and
      referral to treatment (SBIRT) model for youth with chronic medical conditions (YCMC) for
      delivery at point of care during a routine healthcare visit, through conducting a rigorous
      randomized control trial among adolescent patients with type 1 diabetes (TID) or
      rheumatologic conditions. The secondary goal is to assess the attitudes and knowledge of
      parents of these same adolescents, to explore links between parent beliefs and adolescent
      behavior around substance use.
    

Detailed description: 
      The proposed project is a randomized control trial to assess the efficacy of an SBIRT model
      tailored to youth with chronic medical conditions. This trial is being built into a larger,
      longitudinal cohort study to assess whether a set of brief, substance specific questions can
      accurately predict adolescent substance use outcomes when compared to more lengthy, criterion
      standard assessment questions, in cross-sectional and prospective analysis. The first
      component of the project will consist of pre-testing an assessment battery and brief
      electronic intervention with a small sample of 14-17 year old youth. In the second component
      the investigators will randomize consented eligible participants into intervention or control
      arms of the study and administer the 1) Baseline Assessment Battery and the 2) Brief
      Intervention OR Treatment as Usual (TAU). In the third component the investigators will
      follow up with all participants at 6 and then 12 months after study entry to reassess rates
      of substance use through follow up assessment batteries.

      At baseline, the investigators will also attempt to enroll parents of all participants who
      are present at the time of enrollment. The investigators will separately consent and
      administer a brief assessment battery to parents to assess their knowledge and attitudes
      around substance use, as well as opinions and attitudes regarding other health and risk
      behaviors.
    

Intervention name(s): Brief psycho-educational intervention
Intervention type(s): Behavioral
Intervention description(s): Participants in the intervention arm will receive a computerized brief intervention composed of tailored feedback and psycho-education specific to their chronic condition.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Acute and Chronic Effects of Avena Sativa on Cognition and Stress
Condition: Cognitive Change; Stress, Psychological; Mood
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      The flavanoid and terpene phytochemicals present in wild green oat interact with multiple
      mechanisms relevant to brain function; including those which would modulate cognition and
      stress. The current study aims to test this in a group of N=128 males and females between the
      ages of 35-65yrs before and after 28 days supplementation of placebo, 300-, 600- and 900mg of
      a wild green oat extract.
    

Detailed description: 
      The flavanoid and terpene phytochemicals present in wild green oat interact with multiple
      mechanisms relevant to brain function; including those which would modulate cognition and
      stress. The current study aims to test this in a group of N=128 males and females between the
      ages of 35-65yrs before and after 28 days supplementation of placebo, 300-, 600- and 900mg of
      a wild green oat extract. The study is randomized (within x3 age categories also; 35-45,
      46-55, 56-65yrs), placebo controlled and counterballanced across parallel groups.
      Participants will first attend a training/screening session followed by x2 lab-based testing
      sessions, 28 days apart. In the lab-based sessions participants will complete baseline
      cognitive assessments; including whilst undergoing a stressful observed methodology (the
      observed multi-tasking stressor or 'OMS'). Here galvanic skin response and heart rate will be
      measured and before and after the OMS participants will provide a saliva sample which will be
      analysed for cortisol and alpha-amylase levels. This procedure will be repeated 120- and 240-
      minutes post-dose. Between the lab-based sessions participants will complete mood scales via
      a mobile phone application 'cognimapp'.
    

Intervention name(s): Avena sativa; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A supplement derived from wild green oat; Maltodextrin
Other intervention name(s): Wild green oat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
CAFE Comparison of Atypicals in First Episode of Psychosis
Condition: Schizophrenia; Psychotic Disorders; Mental Health; Mental Disorders
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effectiveness, tolerability, and efficacy of the
      currently available atypical antipsychotic drugs olanzapine (2.5-20 mg/day), quetiapine
      (100-800 mg/day) and risperidone (0.5-4 mg/day) in patients with schizophrenia,
      schizophreniform disorder, or schizoaffective disorder who are experiencing their first
      psychotic episode.
    


Intervention name(s): Olanzapine, risperidone
Intervention type(s): Drug
Intervention MeSH terms: Olanzapine; Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Immunogenicity of Repeated Follicle Stimulating Hormone (FSH) Stimulation Cycles
Condition: Oocyte Donation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate immunogenic potential of FSH-IBSA in healthy
      volunteers undergoing controlled ovarian hyperstimulation (COH) in an oocyte donation
      program.
    


Intervention name(s): FSH (Follicle Stimulating Hormone)
Intervention type(s): Drug
Intervention MeSH terms: Hormones; Follicle Stimulating Hormone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Efficacy and Safety of a Combination Containing Myo-inositol, D-chiro-inositol, Alpha-lactalbumin, Zinc and Extract of Gymnema Sylvestre in Subjects Diabetic Patients.
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Mellitus type 2 diabetes (T2MD) is a chronic disease characterized by high glucose plasmatic
      level due to an alteration of insulin function. Several authors have correlated this altered
      function to an inositol depletion. The main present member of inositol family in biological
      systems is undoubtedly myo-inositol, a precursor of several second messengers, widely
      involved in insulin signalling. For this reason this molecule is considered an
      insulin-sensitizer. The high excretion of inositol in T2MD patients is frequent, inducing a
      myo-inositol depleted state that favours the onset of insulin resistance, impairing the
      activity of this hormone. The aim of this study is to evaluate the efficacy and the safety of
      a food supplement containing myo-inositol in T2MD patients.
    


Intervention name(s): Myo-inositol, D-chiro-inositol, Gymnema sylvestre, Zinc and Alpha-lactalbumin; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Myo-inositol (1950 mg), D-chiro-inositol (50 mg), Gymnema sylvestre (250 mg), Zinc (7,5 mg) and Alpha-lactalbumin (50 mg) - Two-times daily on an empty stomach, for 6 months; Placebo - Two-times daily on an empty stomach, for 6 months
Intervention MeSH terms: Inositol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; Myo-inositol; Gymnema sylvestre
Association of Keratinised Mucosa Around Implants and Teeth With Peri-implant/Periodontal Disease and Soft Tissue Conditioning
Condition: Peri-Implantitis; Soft Tissue; Bone Gain
MeSH terms: Peri-Implantitis
Study type: Interventional

Summary: 
      Lack of keratinised mucosa around dental implants and teeth is associated with plaque
      accumulation and worse tissue conditions. However, there is lack of data on the influence of
      the presence/lack of keratinised mucosa on the periodontal condition. Hence, soft tissue
      conditioning by grafting with a gingival graft is aimed at improving the quality of the
      peri-implant conditions
    


Intervention name(s): Free gingival graft obtained from the palate and debridement of the peri-implant lesion
Intervention type(s): Procedure
Intervention description(s): granulation tissue debridement and grafting of a free gingival strip obtained from the palate
Intervention model: Single Group Assignment
Intervention model description: Single-prospective one-arm study
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HGP1602 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics,
      safety and tolerability of HGP1602 in healthy subjects.
    


Intervention name(s): HGP1812; HGP1602
Intervention type(s): Drug; Drug
Intervention description(s): Dapagliflozin (Forxiga) 10mg; Dapagliflozin 10mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment