bioihbjkbjnl/mcl2 huggingface dataset:
Combination of Lenalidomide and Dexamethasone in Treatment of Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study for elderly myeloma patients lenalidomide plus low-dose dexamethasone until
      progression is being compared with age-adjusted tandem high-dose melphalan 140 mg/m²
      augmented by induction with 3 cycles of lenalidomide plus low-dose dexamethasone before
      transplantation and lenalidomide maintenance after transplantation.
    


Intervention name(s): Lenalidomide, Dexamethasone; Lenalidomide, Dexamethasone, PBSCT
Intervention type(s): Drug; Drug
Intervention description(s): Rd until progression or max. 5 years (Rd = lenalidomide 25 mg d1-21/28d + dexamethasone 40 mg po d1, d8, d15, d22/28d); Induction with 3 cycles Rd, tandem high dose melphalan (140 mg/m²) with autologous peripheral blood stem cell transplantation (PBSCT) followed by lenalidomide maintenance (10 mg/day) until progression or max. 5 years
Other intervention name(s): Revlimid; Revlimid
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Lenalidomide; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Continuous Positive Airway Pressure and Acetazolamide to Treat Sleep Apnea Syndrome Patients at Altitude
Condition: Obstructive Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to investigate the effect of nasal continuous positive airway
      pressure in combination with acetazolamide as a treatment for sleep related breathing
      disturbances in patients with the obstructive sleep apnea syndrome living at low altitude
      during a sojourn at moderate altitude.
    


Intervention name(s): acetazolamide; nocturnal continuous positive airway pressure; placebo
Intervention type(s): Drug; Procedure; Drug
Intervention description(s): acetazolamide 250mg 1/0/2; continuous positive airway pressure; placebo capsules
Other intervention name(s): Diamox (trade name); placebo capsules; placebo capsules
Intervention MeSH terms: Acetazolamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: apnea; sleep; altitude; hypoxia; treatment; CPAP
A Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at Three Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Tiotropium
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to evaluate the dose-response relationship and efficacy of AZD9668
      at 3 dose levels compared with placebo in symptomatic COPD patients by assessing effects on
      lung function and symptoms of COPD.
    


Intervention name(s): AZD9668; AZD9668; AZD9668; AZD9668 Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 x 30 mg oral tablets twice daily (bid) for 12 weeks; 2 x 10 mg oral tablets twice daily (bid) for 12 weeks; 2 x 2.5 mg oral tablets twice daily (bid) for 12 weeks; 2 x Matched placebo to oral tablet twice daily (bid) for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Chronic; Obstructive; Pulmonary; Lung; Respiratory disease; Efficacy; Safety and tolerability; Placebo-controlled; Pharmacokinetics; COPD
A Research Study of How NNC0174-0833 Behaves in Chinese Volunteers Who Are Normal Weight, Overweight or With Obesity
Condition: Overweight and Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to look at how the study medicine behaves in participants body and
      how it is removed from their body.

      The study compares three different doses of the study medicine in Chinese healthy men.

      Participant will either get 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833 which dose participant get
      is decided by chance.

      NNC0174-0833 is a new medicine and has not been approved by the Center for Drug Evaluation.

      We are testing the study medicine to make a medicine that can help people lose weight.

      Participant will get 1 injection by a study nurse or doctor at the clinic. The injection will
      be with a needle in a skin fold in the stomach area.

      The study will last for about 5 months. But participants participation will last about 2
      months.

      Participant will have 8 clinic visits with the study staff. One of these visits will be a
      7-day, 6-night stay.

      At all visits, except the information visit, participant will have blood drawn along with
      other clinical examinations.

      Participants will be asked about their health, medical history and habits including mental
      health.
    


Intervention name(s): NNC0174 0833
Intervention type(s): Drug
Intervention description(s): Participants will either get a single dose of 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833, administered subcutaneously (s.c., under the skin)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Slow-release Locally Administered 0.02% Hypochlorite Formulation
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      Aim: The presence of bacterial plaque is associated with the development of periodontal
      inflammation. The aim of this single-blind randomized clinical study was to prospectively
      evaluate the efficacy of two different agents in a staged approach for nonsurgical
      periodontal treatment in terms of clinical and patients related outcomes in a cohort of
      patients with periodontitis: NitrAdine® based disinfectant formula (PerioTabs®) vs
      Chlorhexidine 0.12 toothpaste and mouthwash 0.20.

      Material and methods: Patients with a diagnosis of periodontal disease (stage I-III)
      scheduled for non surgical periodontal treatment were randomly allocated to the preparatory
      home use of a chlorhexidine mouthwash or a NitrAdine® based brushing solution called
      PerioTabs® for 10-15 days. Active decontamination with ultrasonic scalers was performed after
      the completion of the preparation period. Clinical and patient-related outcomes were recorded
      at baseline, at the moment of professional intervention, and after 30 and 90 days from
      baseline.
    


Intervention name(s): PerioTabs® brushing solution; Chlorhexidine 0.12 %
Intervention type(s): Combination Product; Combination Product
Intervention description(s): PerioTabs® contains a non-antibiotic biofilm removal complex called NitrAdine®.Its anti-biofilm action is based on the combination of surfactant-induced protein denaturation and slow release of a non-toxic concentration of hypochlorite (0.02%).; chlorhexidine 0.12 % toothpaste and chlorhexidine 0.2% mouth rinse
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Energy Regulation and Nutritional Status of Children: A Satiation Study
Condition: Underweight; Stunting; Healthy
MeSH terms: Thinness
Study type: Interventional

Summary: 
      This is study among children attending child welfare clinics in Greater Accra Region of
      Ghana. The investigators want to find out if moderately malnourished children regulate the
      food energy intake similarly to healthy children, using an established method to assess
      energy compensation.
    

Detailed description: 
      Malnutrition originates from a complex interplay between genes and environment, manifesting
      in changes to hormones, metabolism, and behaviour. Energy regulation which determines food
      intake or avoidance plays a significant role in the cause, prevention and treatment of
      malnutrition. There is however limited knowledge of how energy regulation develops in
      children and its effect on their nutritional status in the context of undernutrition in
      children. A good understanding of energy regulation in children is therefore essential in
      designing interventions for tackling infant malnutrition.

      A standardised energy compensation study will be undertaken in 60 children- 20 moderately
      malnourished, 20 stunted and 20 healthy. At two visits at least a week apart, the children
      will be given one of two similar tasting drinks in random order, one with very few calories
      and another with extra, without them knowing which is which. After 30 minutes they will eat
      as much as they want of a standardized lunch. All foods and drinks offered will be weighed
      before and after, to calculate the amount of energy eaten in total after the low energy
      drink, compared to the high energy drink.
    

Intervention name(s): High energy preload; Low energy preload
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Tests the extent to which participants reduce their food intake at a meal following ingestion of a high energy preload drink.; Tests the amount participants eat at a meal following ingestion of a low energy preload drink
Other intervention name(s): Satiation study; Satiation study
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: cross-over energy compensation study, participants acting as their own controls
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Rapamycine vs Placebo for the Treatment of Inclusion Body Myositis
Condition: Inclusion Body Myositis (IBM)
MeSH terms: Myositis; Myositis, Inclusion Body
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Sporadic Inclusion Body Myositis (IBM) is the most frequent inflammatory myopathy in patients
      over 50. It is a slowly progressive, but today untreatable (notably by classical
      immunosuppressants) disease.

      Rapamycin used in organ transplantation blocks the activity of T effector cells, preserves T
      regulatory cells and induces autophagy (protein degradation), all parameters impaired during
      IBM.

      RAPAMI is a prospective, randomised, controlled, double blind, monocentric, phase IIb trial
      evaluating rapamycine against placebo.
    


Intervention name(s): Rapamycin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Experimental: rapamycin oral solution, 2 mg/day during one year Comparator: placebo; Comparator: placebo
Other intervention name(s): Sirolimus; Rapamune; Phosal
Intervention MeSH terms: Sirolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Prospective Cohort Study on the Clinical Trajectory of Resected Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      Hepatocellular carcinoma (HCC) is the 6th most common cancer in the world but the 2nd most
      important cause of cancer death. Because of its highly heterogeneous nature, the current
      approach to identifying druggable targets have not delivered efficacious therapies in HCC and
      is a main reason for the high case fatality. Even when surgical resection is potentially
      curative in early disease, tumor recurrence remains high and long term survival poor because
      of the absence of useful adjuvant therapy.

      To address these unmet needs, the investigators bring together internationally recognized
      scientists from genomics and immunology and established clinician investigators in a
      synergistic team. This TCR capitalizes on recent collaborative advances made by the PIs in
      the consortium. The investigators have shown through multi-region sampling of freshly
      resected HCC and phylogenetic analysis, that significant intra-tumoral heterogeneity exists
      and have identified the specific positions of known clonal drivers. Simultaneously the
      investigators have analyzed the immune landscape of the tumor microenvironment with deep
      immune-phenotyping and found unique inter-patient immune landscapes predictive of clinical
      trajectory.

      This TCR is a prospective study that samples resected HCC from multi-ethnic sites within the
      established Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group, which has enrolled
      approximately 1000 patients through 6 multi-center trials in 35 centers in the region.
      Clinical trajectories are tracked and genomic and immunological studies are repeated when
      tumors recu r, to confirm clonally dominant driver mutations and immunological processes that
      are targetable. Concurrently, representative pre-clinical models will be developed from the
      tissues sampled.

      The investigators aim to combine these approaches to overcome the challenges posed by genomic
      heterogeneity and to guide the development of therapeutics and precision medicine in HCC.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who have undergone resection of HCC with curative intent with a R0 and R1
        resection margin
      
Biospecimen description: 
      Tumour samples Blood samples Urine samples
    
Keywords: Intra-tumour heterogeneity; Cancer immunotherapy; Tumour microenvironment; Driver mutations; Precision Medicine
Effectiveness of the Music With Structured Verbal Training During Prostate Biopsy
Condition: Pain; Anxiety; Satisfaction; Urological Nursing
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Transrectal ultrasound (TRUS) guided prostate biopsy is a gold standard method widely used in
      the diagnosis of prostate cancer. This procedure can be very painful and anxious for men.
      Various pharmacological methods can be used to relieve patients' pain and discomfort during
      TRUS-guided prostate biopsy. Although there is still no consensus on the solution suggestions
      for pain and anxiety due to biopsy, it is known that music, which is a non-pharmacological
      method, is effective in this regard. The aim of this study is to evaluate the effect of music
      with structured verbal training on patients' pain, anxiety and satisfaction levels during
      transrectal ultrasound-guided prostate biopsy.
    

Detailed description: 
      Although there have been several studies examining the effect of music on pain and / or
      anxiety during TRUS prostate biopsy, only one study has been found examining the effect of
      stress management (music and one-to-one simulation training) on patients' pain and anxiety
      levels. In addition, there is only one study on the effectiveness of the training method
      (written and video-based training) on anxiety levels of patients related to prostate biopsy.
      For this reason, it is thought that music will be more effective on pain and anxiety levels
      along with structured verbal training to alleviate the discomfort associated with patients'
      biopsy procedure.
    

Intervention name(s): Music with Structured Verbal Training
Intervention type(s): Other
Intervention description(s): Structured verbal training on prostate biopsy was given to the intervention group before the procedure, and then patients in this group listened to the music they preferred during the procedure with headphones.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Anxiety; Nursing; Pain; Satisfaction; Prostate biopsy
The Oxygenation of the Brain During Caesarean Section
Condition: Complications; Cesarean Section
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the impact of phenylephrine versus ephedrine on
      organ perfusion, in women undergoing caesarean section receiving spinal anaesthesia. The
      organ perfusion is estimated by measuring the maternal cerebral oxygenation by
      NIRS(Near-infrared spectroscopy)and the foetal heartrate.
    


Intervention name(s): Ephedrine; Phenylephrine
Intervention type(s): Drug; Drug
Intervention description(s): An infusion with a maximum of 3 mg/minute for maximum 60 minutes or if sideeffects develope.; An infusion of maximum 4 mg/hour for maximum 60 minutes.
Other intervention name(s): Efedrin; Ephedrine hydrochloride; Phenylephrine Hydrochloride; Metaoxedrin
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Ephedrine; Pseudoephedrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spectroscopy, Near-Infrared; Fetal heartrate; Ephedrine; Phenylephrine
Eurosarc Trial of Linsitinib in Advanced Ewing Sarcoma
Condition: Relapsed Ewing Sarcoma; Refractory Ewing Sarcoma
MeSH terms: Sarcoma; Sarcoma, Ewing
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an international, multi-centre, single arm Bayesian designed phase 2 study to
      identify and determine the safety and activity of anti-IGF-1/IR inhibition in patients with
      relapsed and/or refractory ESFT. Approximately 40 patients will be recruited from 5-7
      European centres. Each patient will be treated with single agent linsitinib, 600 mg orally
      once a day for days 1-3, 8-10 and 15-17 on a 21 day cycle until disease progression or undue
      toxicity.
    

Detailed description: 
      An important development in ES has been the identification of IGF-1R pathway dependency. The
      reasons for the remarkable single agent efficacy observed in a small subset of patients
      remains unknown, as is the relative lack of efficacy in the majority of patients. There may
      be heterogeneity in response due to partial signal pathway inhibition at the tumour level,
      inherent resistance in ES cells or the presence of alternative pathway activation through
      IR-A receptor signalling.

      Here we aim to establish pharmacodynamic responses in ES tumours using functional imaging
      18FDG-PET-CT and repeat post treatment biopsy for biomarker responses, toxicity and clinical
      outcome to the dual anti-IGF-1R/IR kinase blocking single agent linsitinib.

      This is a single arm phase 2 study utilising adaptive Bayesian analysis. Approximately 40
      patients will be recruited the national bone sarcoma centre in 5 EU countries over 18 months.

      Eligible patients will take 4x 150 mg tablets once a day, days 1-3 of the week followed by 4
      days off - repeated for 3 weeks = one treatment cycle. Patients can remain on treatment for
      as long as they gain clinical benefit.

      The primary objectives are to determine the effect of linsitinib on the patient's tumours in
      terms of changes in biomarker and PET scans and to establish the safety of the trial drug
      (linsitinib) in Ewing sarcoma at the dose and treatment schedule being used in the trial.
    

Intervention name(s): Linsitinib
Intervention type(s): Drug
Other intervention name(s): OSI-906; ASP7487
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Linsitinib; anti-IGF-1R/IR; Ewing Sarcoma; dual IGF-1R/IR inhibition; Relapsed Ewing Sarcoma; Refractory Ewing Sarcoma; Metastatic Ewing Sarcoma
Study Assessing Safety and Therapeutic Activity of AFFITOPE® PD01A and PD03A in Patients With Early MSA
Condition: Multiple System Atrophy; Neurodegenerative Diseases
MeSH terms: Neurodegenerative Diseases; Multiple System Atrophy; Shy-Drager Syndrome; Atrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized controlled parallel Group phase I study to investigate the safety and
      immunological/ therapeutic activity of two new vaccines, AFFITOPE® PD01A and AFFITOPE® PD03A,
      given to patients with early Multiple System Atrophy (MSA).

      In total 30 patients are planned to be enrolled in the study: 12 patients in each treatment
      arm who will receive either 75µg AFFITOPE® PD01A (with adjuvant) or 75µg AFFITOPE® PD03A
      (with adjuvant) and 6 patients in the control group who will receive the reference substance
      (Placebo). Over a study duration of 52 weeks, the study participants will receive 4
      injections as basic immunization in a 4-weekly interval and 1 boost immunization 36 weeks
      after the first injection. Male and female patients aged 30 to 75 years can participate in
      the trial. 2 study sites in France (Bordeaux and Toulouse) will be involved.

      AFF009 is part of the project SYMPATH funded by the European Commission
      (FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602999).
    


Intervention name(s): AFFITOPE® PD01A + Adjuvant; AFFITOPE® PD03A + Adjuvant; Adjuvant without active component
Intervention type(s): Biological; Biological; Biological
Intervention description(s): s.c. injection; s.c. injection; s.c. injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment