bioihbjkbjnl/mcl2 huggingface dataset:
Neck Dissection Via a Robot-assisted Transaxillary Approach in Patients With Squamous Cell Carcinoma of the Epi-larynx
Condition: Carcinoma, Squamous Cell
MeSH terms: Carcinoma; Carcinoma, Squamous Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The main hypothesis of this study is that it is possible to make a unilateral selective
      dissection of ganglion levels IIa, III and IV using an endoscopic transaxillary approach via
      the da Vinci robotic system to reduce scarring, while respecting patient safety.

      Feasibility will be assessed by two combinded criteria: 1) performance of the surgical
      procedure respecting the different stages of visualization and dissection of key anatomical
      elements; 2) obtain a minimum of 9 lymph nodes when analyzing pathological evidence of the
      dissection.
    

Detailed description: 
      Secondary objectives include the following:

      A. Describe certain technical variables: surgical time, extent of blood loss, need for
      conversion to open surgery, anesthesia procedure used, the level of difficulty and speed
      associated with each surgical step, length of stay, B. Describe the pathological findings for
      each patient, C. Evaluate neurological complications (function of cranial nerve pairs X, XI,
      XII, brachial plexus, cervical sympathetic) D. Identify specific complications, E. Evaluate
      post-operative pain, F. Evaluate the scar outcome at 6 and 12 months G. Describe the
      oncological results at 6 and 12 months.
    

Intervention name(s): Neck Dissection
Intervention type(s): Procedure
Intervention description(s): Unilateral Selective Neck Dissection at Lymph Node Levels IIa, III and IV Using a Robot-assisted Transaxillary Approach. The robotic system used is the da Vinci system.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Squamous Cell Carcinoma of the Epi-larynx
Phase I Study of Nicotinamide for Early Onset Preeclampsia
Condition: Pregnancy Induced Hypertension; Superimposed Preeclampsia; Hypertension
MeSH terms: Pre-Eclampsia; Hypertension, Pregnancy-Induced; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I study of vitamin B3-amide (nicotinamide) dietary supplementation in
      pregnant women with early onset preeclampsia. The investigators will enroll 10 pregnant women
      at 24-32 weeks' gestation with the diagnosis of preeclampsia. If the woman is anticipated to
      remain undelivered for 48 hours after diagnosis she will receive vitamin B3-amide, 500 mg/day
      given in the morning (n=5) or 1000 mg given in the morning (n=5), continuing until delivery
      or for 14 days, whichever occurs first. Maternal blood will be collected at baseline and
      twice a day on days 1, 3, and 7 of nicotinamide administration to measure nicotinamide
      metabolites, The objectives of this Phase I study are to to test safety of nicotinamide.
    


Intervention name(s): Nicotinamide 500 mg; Nicotinamide 1000 mg
Intervention type(s): Drug; Drug
Intervention description(s): Nicotinamide 500 mg taken by mouth each morning; Nicotinamide 1000 mg taken by mouth each morning
Other intervention name(s): Vitamin B3 amide; Vitamin B3 amide
Intervention MeSH terms: Vitamins; Niacinamide; Niacin; Nicotinic Acids; Vitamin B Complex
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Phase 1 dose escalation study
Masking: None (Open Label)
Primary purpose: Other
Keywords: preeclampsia; pregnancy-induced hypertension; nicotinamide
Use of N-Acetylcysteine (NAC) in Fingernail Biting
Condition: Onychophagia
Study type: Interventional
Phase: Phase 3

Summary: 
      To conduct a pilot randomized placebo-controlled feasibility trial of N-acetylcysteine (NAC)
      in onychophagia, preliminarily assessing the tolerability and effects of this pharmacotherapy
      on young adults who bite their fingernails. It is proposed that NAC will help decrease
      fingernail biting.
    

Detailed description: 
      This is a proof-of-concept pilot placebo-controlled trial of N-acetylcysteine (NAC) in young
      people who bite fingernails. The primary interest is in assessing the feasibility of
      conducting this line of research, while preliminarily exploring potential effects on nail
      biting, as measured by nail length.
    

Intervention name(s): N-Acetylcysteine (NAC); Placebo
Intervention type(s): Drug; Other
Intervention description(s): This is the medication N-acetylcysteine (NAC); Placebo, designed to match in appearance to NAC
Other intervention name(s): NAC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anxiety; Impulse control; Depression; ADHD; Fingernail Biting; N-Acetylcysteine; NAC
Montelukast in Bronchiolitis Obliterans Syndrome
Condition: Bronchiolitis Obliterans; Lung Transplantation; Graft Rejection
MeSH terms: Bronchiolitis; Bronchiolitis Obliterans; Bronchiolitis Obliterans Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Chronic rejection (or Bronchiolitis Obliterans syndrome-BOS) is a major cause of mortality
      and morbidity after lung transplantation. Because montelukast has been shown to be of some
      efficacy in a similar disease (Obliterative Bronchiolitis after bone marrow transplantation),
      the investigators would like to test if montelukast can indeed slow down the progression of
      chronic rejection after lung transplantation.
    

Detailed description: 
      -  Prospective, interventional, randomized, double-blind, placebo-controlled trial.

        -  Clinical setting (tertiary University Hospital).

        -  Investigator-driven, no pharmaceutical sponsor.

        -  Lung transplant recipients.

        -  Add-on of study-drug (placebo or montelukast) to 'standard of care'

        -  1:1 inclusion ratio (placebo:montelukast).

        -  Randomisation at diagnosis of chronic rejection after informed consent.
    

Intervention name(s): Montelukast
Intervention type(s): Drug
Intervention description(s): After diagnosis of fBOS every day an oral capsule with 10 mg montelukast of placebo
Other intervention name(s): Montelukast TEVA
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: montelukast; cysteinyl leukotriene; lung transplantation; bronchiolitis obliterans syndrome
Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety, tolerability, and maximum
      tolerated dose (MTD)/maximum tolerated combination dose (MTCD) or recommended phase 2 dose
      (RP2D) of AMG 994 as monotherapy and AMG 994 in combination with AMG 404 in participants with
      advanced solid tumors.
    

Detailed description: 
      AMG 994 will be administered by short term intravenous (IV) infusion once weekly in each
      28-day cycle and AMG 404 will be administered by short-term IV infusion once every 4 weeks
      (Q4W) in a 28 day cycle (on day 1 of cycle 2 and beyond). The study will be conducted in 2
      parts: Part 1 - Dose Exploration and Part 2 - Dose Expansion.
    

Intervention name(s): AMG 994; AMG 404
Intervention type(s): Drug; Drug
Intervention description(s): Administered as an intravenous (IV) infusion.; Administered as an intravenous (IV) infusion.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mesothelin expression
A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists
Condition: Chronic Idiopathic Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is a global Phase III, multicenter, randomized, double-blind, placebo controlled,
      parallel-group study to evaluate the safety and efficacy of omalizumab administered
      subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged
      12-75 who have been diagnosed with chronic idiopathic urticaria (CIU) who remain symptomatic
      despite standard-dosed H1 antihistamine treatment (including doses up to 4 times above the
      approved dose level), H2 blockers, and/or leukotriene receptor antagonists (LTRA).
    


Intervention name(s): Omalizumab; Placebo; H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist; Diphenhydramine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.; Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.; Participants were required to maintain stable doses of their pre-randomization combination therapy with an H1 antihistamine and either an H2 blocker or leukotriene receptor antagonist, or all 3 drugs in combination, throughout the 24-week treatment period and 16-week follow-up period of the 40-week study.; Participants were provided with diphenhydramine 25 mg for itch relief on an as-needed basis, up to a maximum of 3 doses within 24 hours for the duration of the 40-week study.
Other intervention name(s): Xolair
Intervention MeSH terms: Omalizumab; Diphenhydramine; Promethazine; Leukotriene Antagonists; Histamine H1 Antagonists; Histamine Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children
Condition: Partial Epilepsy in Children and Adolescents
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the efficacy and safety of Eslicarbazepine acetate
      (BIA 2-093) when given with other anti-epileptic drugs to treat children with partial
      seizures whose condition has not been controlled by other drug treatments.
    

Detailed description: 
      Partial epilepsy, the commonest form of epilepsy, is a difficult condition to treat with many
      patients continuing to have symptoms despite trying several medications. Lack of efficacy and
      adverse effects are commonly associated with current anti-epileptic drugs.

      This study will examine the efficacy in addition to safety and tolerability of a new
      anti-epileptic drug, Eslicarbazepine acetate (BIA 2-093), as an adjunctive therapy for
      refractory partial seizures in children.

      The primary analysis variables are:

        -  The responder rate (the proportion of patients with at least a 50% reduction in
           standardised seizure frequency)

        -  The relative reduction in standardised seizure frequency
    

Intervention name(s): Eslicarbazepine acetate (BIA 2-093); Eslicarbazepine acetate
Intervention type(s): Drug; Drug
Intervention description(s): Part I - 8-week observational baseline period followed by a 6-week double-blind titration period, a 12-week double-blind maintenance period, a double-blind tapering-off period, and a 4-week observational period.
The recommended target dose of double-blind study treatment will be 20mg/kg/day.
Part II: At the end of part I, there is an option to enter a long-term open-label extension period to receive Eslicarbazepine acetate for 1 year.; Part I: 8-week observational baseline period followed by a 6-week double-blind titration period, a 12-week double-blind maintenance period, a double-blind tapering-off period, and a 4-week observational period.
Part II: At the end of part I, there is an option to enter a long-term open-label extension period to receive Eslicarbazepine acetate for 1 year.
Other intervention name(s): BIA 2093; BIA 2093
Intervention MeSH terms: Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Epilepsy; Partial; Refractory; Children; Adolescents; Adjunctive; Randomised; Double-blind; Placebo-controlled; Parallel-group
Long Term Follow up Treatment With Levetiracetam in Subjects of 4 Years and Older With Generalized Epilepsy
Condition: Generalized Epilepsy
MeSH terms: Epilepsy; Epilepsy, Generalized
Study type: Interventional
Phase: Phase 3

Summary: 
      An open-label, follow-up study to evaluate the safety and efficacy of levetiracetam (LEV), in
      children (≥ 4 years old), adolescents and adults suffering from primary generalized seizures.
    


Intervention name(s): Levetiracetam 166 mg; Levetiracetam 250 mg; Levetiracetam 500 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Active Substance: Levetiracetam
Pharmaceutical Form: Tablet
Concentration: 166 mg
Route of Administration: Oral use; Active Substance: Levetiracetam
Pharmaceutical Form: Tablet
Concentration: 250 mg
Route of Administration: Oral use; Active Substance: Levetiracetam
Pharmaceutical Form: Tablet
Concentration: 500 mg
Route of Administration: Oral use
Intervention MeSH terms: Levetiracetam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Generalized Epilepsy, Primary Generalized Seizures; Keppra, Levetiracetam
Maintenance of Remission With Budesonide Orodispersible Tablets vs. Placebo in Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to prove the superiority of a 48-weeks treatment with budesonide
      orodispersible tablets versus placebo for the maintenance of clinico-pathological remission
      in patients with eosinophilic esophagitis.
    


Intervention name(s): Budesonide 0.5mg orodispersible tablet twice daily; Budesonide 1mg orodispersible tablet twice daily; Placebo orodispersible tablet twice daily
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): BUL 0.5mg BID; BUL 1mg BID; Placebo BID
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Azelaic Acid on Demodex Counts in Rosacea
Condition: Rosacea
MeSH terms: Rosacea
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to measure the effects of azelaic acid on Demodex folliculorum
      counts and disease condition via a split face design in approximately twenty patients with
      mild to moderate rosacea. The investigators hypothesize that treatment of rosacea with
      azelaic acid will lead to a decreased Demodex folliculorum count as well as an improvement in
      lesion count and redness.
    

Detailed description: 
      This is a split face, randomized, single blind, single center study. Male and female
      (non-pregnant, non-nursing) subjects, age 18 or greater, with mild to moderate papulopustular
      facial rosacea, with bilateral facial involvement, and no more than two nodules will be
      enrolled. Subjects will be randomized 1:1 by the study coordinator using a standard
      randomization table to receive azelaic acid twice daily on either the left side or the right
      side of the face and no treatment on the other side of the face. Subjects must have a
      positive Demodex folliculorum standardized skin surface biopsy, defined at >5 mites cm at
      Screening/Baseline on at least one of two different SSSB specimens on bilateral sides of the
      face. The SSSB test location will ideally be on the cheek, but may be done in the most
      disease involved area. Subjects will be seen at Screening/Baseline, Week 1 and Week 4.
      Standard topical washout periods will be observed. At each visit, rosacea will be evaluated
      by lesion count, IGA and two Demodex SSSB tests done on each side of the face. Safety will be
      monitored at each visit using the Investigator Skin Irritation Assessment.
    

Intervention name(s): Azelaic acid
Intervention type(s): Drug
Intervention description(s): 15% gel twice daily for four weeks to one side of face
Other intervention name(s): Finacea Gel
Intervention MeSH terms: Azelaic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a split face, randomized, single blind, single center study. Male and female (non-pregnant, non-nursing) subjects, age 18 or greater, with mild to moderate papulopustular (based on Investigator Global Assessment) facial rosacea, with bilateral facial involvement, and no more than two nodules will be enrolled. Subjects will be randomized 1:1 by the study coordinator using a standard randomization table to receive azelaic acid (Finacea® Gel, 15%) twice daily on either the left side or the right side of the face and no treatment on the other side of the face.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Rosacea; Wake Forest; Demodex; Finacea Gel
Habitual Abortion Study: Oral Dydrogesterone Treatment During Pregnancy in Women With Recurrent Miscarriage
Condition: Recurrent Miscarriage
MeSH terms: Abortion, Spontaneous; Abortion, Habitual; Recurrence
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical study is to demonstrate the shift from inflammatory cytokines to
      non-inflammatory cytokines in women suffering from habitual abortion treated with
      dydrogesterone (Duphaston).
    


Intervention name(s): Dydrogesterone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg/day, oral; Placebo
Intervention MeSH terms: Dydrogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pregnancy; Immunology; Unexplained recurrent miscarriage
FTIH Study With GSK958108
Condition: Premature Ejaculation
MeSH terms: Premature Ejaculation
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is the first administration of GSK958108 to man. The study will evaluate the
      safety, tolerability and pharmacokinetics of single ascending doses of GSK958108 and evaluate
      the effect of food on GSK958108 pharmacokinetics
    


Intervention name(s): GSK958108; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK958108 oral tablets will be available with dosing strengths of 1 milligram, 5 milligrams, 25 milligrams and 50 milligrams. It will be a brownish-yellow film coated round shape tablet. The tablets have to be swallowed completely with 240 milliliters of water, without chewing over a period of five minutes.; Placebo tablets will be brownish-yellow film coated round shape tablets, administered orally. The tablets have to be swallowed completely with 240 milliliters of water, without chewing over a period of five minutes.
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: Premature ejaculation.; FTIH,; GSK958108,; 5HT1a antagonist,
Emergency Radiotherapy in Metastatic Spinal Cord Compression of Patients With Non-small Cell Lung Cancer
Condition: Neurological Outcome; Survival From First Diagnosis Metastatic Spinal Cord Compression to Death
MeSH terms: Spinal Cord Compression; Emergencies
Study type: Observational [Patient Registry]

Summary: 
      Acute neurological deficit in metastatic spinal cord compression is an emergency condition in
      radiation oncology. Despite some reports about the high efficacy of radiation treatment for
      oncological emergencies, a standard of care is not well defined, especially the time interval
      of immediate RT after deficit, and neurological outcome with respect to poor survival in
      non-small cell lung cancer patients. The objective of this trial is to investigate
      neurological outcome after emergency radiotherapy in metastatic spinal cord compression of
      non-small cell lung cancer patients with acute neurological deficit.
    

Detailed description: 
      Subjects and recruitment 15 consecutive patients with histologically confirmed non-small cell
      lung cancer and bone metastases of the thoracic or lumbar segments of the vertebral column
      will be screened for this trial in the Radiooncology Department of the Heidelberg University
      Clinic. Inclusion criteria are an age of 18 to 80 years, acute neurological symptom caused by
      metastatic spinal cord compression, no radiotherapy in this spinal area before, and written
      consent to participate.

      Design and procedures This is a prospective, controlled, explorative trial to investigate the
      neurological outcome after emergency radiotherapy in metastatic spinal cord compression of
      non-small cell lung cancer patients with acute neurological deficit. RT start within 12 hours
      after onset of neurological symptoms. The target parameters will be measured at the start of
      radiotherapy (t0), and six weeks after radiotherapy (RT) (t1). The target parameters comprise
      the documentation and completion of the ASIA Impairment Scale (AIS), and the recording of
      patient-specific data.
    

Intervention name(s): external beam radiotherapy
Intervention type(s): Radiation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        histologically confirmed non-small cell lung cancer and bone metastases of the thoracic or
        lumbar segments of the vertebral column
      
Keywords: emergency radiotherapy; MSCC; spine; neurological outcome
Study Evaluating Drug Interaction Between Multiple Doses of Ketoconazole and a Single Dose of SKI-606
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate a potential pharmacokinetic interaction between SKI-606 and ketoconazole when
      co-administered.
    


Intervention name(s): SKI-606
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment