bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study of Parathyroid Hormone in Patients Needing Additional Stem Cell Mobilization.
Condition: Lymphoma; Multiple Myeloma; Acute Myelogenous Leukemia
MeSH terms: Multiple Myeloma; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety of parathyroid hormone in combination
      with G-CSF when used as a stem cell mobilization regimen for patients who fail to mobilize
      sufficient progenitor stem cells after one or two attempts.
    

Detailed description: 
      Patients will start treatment within 21 days of the determination of inadequate mobilization.
      PTH treatment will be given in 4 cohorts: 40 mcg, 60 mcg, 80 mcg, and 10 mcg. PTH will be
      given on day 1 and continue until stem cell collections are complete or a maximum of 20 days.
      G-CSF 10 mcg/kg will be given on days 10-14 and continue until stem cell collections are
      complete. Patients with inadequate CD34+ cells on Day 14 will meet off study criteria and not
      continue with PTH/G-CSF.
    

Intervention name(s): Stem cell mobilization
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mobilization; Stem Cell; Parathyroid Hormone
Bioequivalence Study Comparing Two Tablet Formulations of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A bioequivalence and food-effect study comparing two tablet formulations of tebipenem pivoxil
      hydrobromide (TBPM-PI-HBr) in healthy adult subjects.
    


Intervention name(s): Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference; Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test
Intervention type(s): Drug; Drug
Intervention description(s): 600 mg (2 x 300 mg tablets) clinical study drug product batch TBPM-PI-HBr.; 600 mg (2 x 300 mg tablets) registration drug product batch TBPM-PI-HBr.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Open-Label, Randomized, Single-Dose, Semi-Replicate, 4-Period, Crossover
Masking: None (Open Label)
Primary purpose: Other
Confirmatory Clinical Study of Oxiplex
Condition: Herniated Lumbar Disk
Study type: Interventional

Summary: 
      This is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded
      clinical study to assess the safety and effectiveness for the reduction of pain and symptoms
      following lumbar surgery.
    


Intervention name(s): Oxiplex; Surgery Only
Intervention type(s): Device; Other
Intervention description(s): Oxiplex is a clear, viscoelastic gel that is applied to operative site during lumbar spine surgery in order to coat the nerve root with a protective barrier.; Single level partial discectomy as per standard of care procedures.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Food-effect on PK and PD of Single Oral Dose of HIP1601 in Healthy Male Subjects
Condition: Heathy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective

      - To evaluate food effect on the pharmacokinetics (PK) of a single oral dose of HIP1601 in
      healthy subjects under fed or fasting condition.

      Secondary objectives

        -  To explore food effect on the pharmacodynamics (PD) of single oral dose of HIP1601 in
           healthy subjects under fed or fasting condition.

        -  To evaluate the safety of single oral dose of HIP1601 in healthy subjects under fed or
           fasting condition.
    


Intervention name(s): HIP1601 40mg
Intervention type(s): Drug
Intervention description(s): Single dosing of HIP1601 40mg, orally
Other intervention name(s): HIP1601
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of PNF on Selective Motor Control and Balance in CP
Condition: CP (Cerebral Palsy)
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Cerebral palsy is attributed to non-progressive disturbances that occurred in the developing
      infant brain or fetal characterized by abnormalities of muscle tone, movement and motor
      skills. PNF technique is thought to have an impact on voluntary motor control and balance
      through stimulation of proprioceptors, so the aim of this study is to determine the effects
      of proprioceptive neuromuscular facilitation technique on selective motor control and balance
      on children with cerebral palsy.
    

Detailed description: 
      A case study was conducted in 2021 to determine the effects of PNF training for improving
      lower limb coordination in 7 years old cerebral palsy child. After the intervention,
      significant improvement is seen in gait parameters, balance, and gross motor functional
      classification score.

      A case report was conducted in 2020, to determine the effectiveness of PNF technique in
      improving lower extremity function in spastic diplegic cerebral palsied adolescent. Patient
      was treated with tone inhibitory and movement facilitatory techniques. There was significant
      change in balance and lower extremity function before and after the treatment.

      There are multiple impairments in spastic cerebral palsy children; the inability to perform
      purposeful voluntary movements is a critical factor in determining functional ability of
      children. Since selective voluntary motor control is an important factor that must be
      achieved in cerebral palsy children, PNF may be considered as a technique to gain selective
      voluntary control and balance proving an important intervention for cerebral palsy children.
    

Intervention name(s): Proprioceptive neuromuscular facilitation techniques.; Traditional physical therapy
Intervention type(s): Other; Other
Intervention description(s): Proprioceptive neuromuscular facilitation stretching which include hold-relax and contract-relax for 6 sec hold, 10 repetitions and 2 min rest in between, for 5 day/week for 4 weeks along with conventional treatment for 40 minutes.; Conventional therapy (ROMs, stretching, strengthening) of lower limbs for 40 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Proprioceptive neuromuscular techniques; Selective voluntary motor control; Balance
Study of CRx-191 to Assess Activity in Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      CRx-191 is a proprietary synergistic combination drug candidate being evaluated by
      CombinatoRx for topical psoriasis therapy. CRx-191 was identified via a proprietary screening
      assay for novel drug combinations demonstrating enhanced inhibition of tumor necrosis factor-
      alpha and interferon-gamma release, cytokines that are implicated in the pathogenesis of
      psoriasis.

      This clinical trial will assess the effectiveness of CRx-191 in reducing the psoriatic
      infiltrate band thickness as measured by transdermal ultrasound. All subjects will receive
      all treatments in separate test fields, with intra-individual comparison of the treatments.
    


Intervention name(s): mometasone furoate; nortriptyline HCl; Vehicle (placebo)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Topical 0.1% mometasone furoate; Topical 0.05% or 0.1% nortriptyline HCl; Topical placebo
Intervention MeSH terms: Mometasone Furoate; Nortriptyline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: CRx-191; Plaque; Psoriasis; nortriptyline hydrochloride; mometasone furoate; psoriatic infiltrate
Manipulation and Myofascial Techniques On Sacroiliac Joint Dysfunction
Condition: Manipulation, Psychologic; Pain; Performance Anxiety; Participation, Patient; Physiotherapists
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      Aimed to compare the effects of High-Velocity Low-Amplitude (HVLA) manipulation and
      myofascial release techniques on performance in healthy individuals with sacroiliac joint
      dysfunction.
    

Detailed description: 
      Aim: aimed to compare the effects of High-Velocity Low-Amplitude (HVLA) manipulation and
      myofascial release techniques on performance in healthy individuals with sacroiliac joint
      dysfunction. Design: Randomized control trial. Setting: University physiotherapy clinic.
      Participiants: Participants aged 18-45 years with confirmed Dysfunction by six clinical
      Sacroiliac Joint diagnostic tests. Intervention: The groups determined as randomly into the
      four groups. Group I (n=14) received HVLA spinal manipulation, Group II (n=14) underwent foam
      roller stretching, Group III (n=14) received a combination of HVLA spinal manipulation and
      foam roller stretching, and Group IV (n=14) underwent sham manipulation as the control group.
      Measures were measured before the acute intervention and right after the intervention.
      Outcomes: Prior to the interventions, participants were evaluated using the Visual Analog
      Scale (VAS) for pain assessment, the Baseline Sit and Reach test for flexibility assessment,
      the Optojump Next system (Via Stradivari, Bolzano) for vertical jump performance and multiple
      jump tests, and the MicroFet2 digital hand dynamometer (United States, Utah) for muscle
      strength measurement. Results: The study groups showed statistically significant improvements
      in performance parameters compared to the control group (p<0.05). Pre-treatment and
      post-treatment performance parameters and pain values were statistically significant in both
      groups (p<0.05). While performance improvements were observed in all four groups, the highest
      changes were generally observed in the HVLA + Myofascial release group. Conclusion:
      Considering the overall results, the combined use of HVLA and Myofascial release in the
      treatment protocol is recommended.
    

Intervention name(s): Comparing to Manipulation and Myofascial Release Techniques
Intervention type(s): Other
Intervention description(s): Randomized Controlled Trials
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The groups determined as randomly into the four groups. Group I (n=14) received HVLA spinal manipulation, Group II (n=14) underwent foam roller stretching, Group III (n=14) received a combination of HVLA spinal manipulation and foam roller stretching, and Group IV (n=14) underwent sham manipulation as the control group. Measures were measured before the acute intervention and right after the intervention.
Masking: None (Open Label)
Primary purpose: Treatment
Olanzapine in Patients With Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The goals of this study are to determine: the safety of olanzapine and any side effects that
      might be associated with it, how olanzapine compares to placebo, whether olanzapine can help
      patients with symptoms of Borderline Personality Disorder (BPD), and how much olanzapine
      should be given to patients.
    


Intervention name(s): Olanzapine; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Efficacy Study of Vitamin D Supplementation to Meticillin Resistant Staphylococcus Aureus (MRSA) Carriers
Condition: Methicillin Resistant Staphylococcus Aureus; Vitamin D3 Deficiency
MeSH terms: Staphylococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to treat persistent MRSA carriers with vitamin D supplementation
      during a 12 month to see if the number of MRSA positive patients can be reduced.
    


Intervention name(s): Cholecalciferol; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Cholecalciferol 4000 IU/day for 12 months; Placebo (mimic of cholecalciferol) in the same amount and same time frame as Cholecalciferol for 12 months
Other intervention name(s): Vigantol Oil (Germany) or Detremin (Sweden)
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Multifamily Psychoeducation and Cognitive Remediation for Recent-Onset Psychosis
Condition: Recent-Onset Psychosis; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder With Psychotic Features; Major Depression With Psychotic Features; Psychotic Disorder Not Otherwise Specified (NOS)
MeSH terms: Schizophrenia; Bipolar Disorder; Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      The goal of this study is to determine whether pairing multifamily group psychoeducation with
      cognitive remediation may facilitate improved outcomes among individuals with recent-onset
      psychosis.
    


Intervention name(s): Multifamily Group Psychoeducation (MFG); Cognitive Remediation (CR)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participation in multifamily psychoeducation comprised of (i) three individual sessions with family and individual with psychosis, (ii) one psychoeducational workshop, and (iiI) twice monthly multifamily meetings to complete structured problem-solving activity; Computer exercises designed to improve cognitive functioning (3hr/wk).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: First-episode psychosis; cognitive remediation; family psychoeducation
Comparative Effect of Chewing Sticks and Toothbrushing on Plaque Removal and Gingival Health
Condition: Plaque Induced Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      The purpose of the proposed study is to compare the effect of chewing sticks (Miswak) and the
      toothbrushes on plaque removal and gingival health.
    

Detailed description: 
      Dental plaque removal is essential in maintaining oral health. Methods for oral hygiene vary
      from country to country and from culture to culture. The use of a wood stick (miswak or
      chewing stick) for brushing the teeth is considered an important tool for oral hygiene care
      in many Afro-Asian communities. The aim of the study is to compare the effect of the chewing
      stick (miswak), and toothbrushing on plaque removal and gingival health. The participants
      comprise 18 healthy Saudi Arabian male volunteers aged 21 to 30 years, at Taibah University
      in Saudi Arabia. The study was designed as a single, blind, randomized split-mouth study.
      Professional tooth cleaning was conducted, and after six weeks use of either the miswak or
      toothbrush on each quadrant, modified plaque and gingival indices, were recorded.
    

Intervention name(s): Salvadora persica; Toothbrush
Intervention type(s): Procedure; Procedure
Intervention description(s): twice daily use, two minutes interval; Twice daily use two minutes interval
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: gingivitis; dental plaque; oral hygiene; toothbrush; chewing sticks
Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency
Condition: Exocrine Pancreatic Insufficiency; Pancreatic Diseases; Digestive System Diseases
MeSH terms: Digestive System Diseases; Gastrointestinal Diseases; Exocrine Pancreatic Insufficiency; Pancreatic Diseases
Study type: Observational

Summary: 
      This study aims at collecting the information related to the safety and effectiveness in the
      pancreatic exocrine insufficiency patients receiving the treatment with LipaCreon for a long
      term in order to evaluate the effective and safe use of LipaCreon.
    

Detailed description: 
      Criteria for evaluation:

        1. Adverse events

        2. Nutritional endpoints

             -  BMI (height [only prior to the start of Lipacreon treatment] and weight)

             -  Serum total protein

             -  Albumin

             -  Total cholesterol

             -  Triglycerides

             -  Haemoglobin

        3. Symptoms related to exocrine pancreatic insufficiency

             -  Steatorrhoea

             -  Frequency of bowel movements

             -  Diarrhoea

             -  Foul stool odour

             -  Decreased appetite

             -  Abdominal distension

        4. Patient's quality of life (QOL)

        5. Degree of general improvement
    

Intervention name(s): Lipacreon
Intervention type(s): Drug
Intervention description(s): This study was an observational study and no intervention was specified
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in
        pancreatic exocrine insufficiency
      
Keywords: Digestive System Diseases; Therapeutic Uses; Pancreatectomy; Gastrointestinal Agents; Pancreatic Diseases; Pancrelipase; Exocrine Pancreatic Insufficiency
Trial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol Abuse
Condition: Suicidal Ideation; Depression; Alcohol Abuse
MeSH terms: Alcoholism; Depression; Depressive Disorder; Suicidal Ideation
Study type: Interventional
Phase: Phase 3

Summary: 
      This project aims to evaluate the potential rapid and sustained antisuicidal and
      antidepressant effects of a single intranasal dose of ketamine in inpatients during a mood
      episode in Major Depressive Disorder (MDD) or Bipolar Disorder (BD) with or without comorbid
      recent abuse of alcohol.
    

Detailed description: 
      Clinicians have a limited ability to predict imminent suicidal behavior and efficacious
      treatments are not available to treat suicidal patients. Thus, Rapid-acting treatments for
      suicidal individuals are truly needed. This project aims to evaluate the potential rapid and
      sustained antisuicidal and antidepressant effects of a single intranasal dose of ketamine in
      inpatients during a mood episode (in Major Depressive Disorder, MDD or Bipolar Disorder, BD)
      with or without comorbid recent abuse of alcohol. These results will elucidate the
      antisuicidal effects of ketamine using the intranasal route along with the identification of
      associated mediators or moderators; this approach has the potential for enormous public
      health impact.
    

Intervention name(s): Intranasal ketamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intranasal ketamine will be prepared as 100mg/ml ketamine in 0.9% saline. An mucosal atomization device will be used to provide 5 intranasal applications of solution (volume 100 μl), separated by 3 minutes, over a total of 15 minutes. Each of five ketamine applications will provide 10 mg of study drug, for a total of 50mg. The dose to be used (0.5-1mg/Kg) is 6 to 18 times lower than the sedation dose (6-9mg/Kg).; Saline alone. An mucosal atomization device will be used to provide 5 intranasal applications of saline (volume 100 μl), separated by 3 minutes, over a total of 15 minutes.
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-Blind, Placebo-Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ketamine; Depression; Suicidal Ideation; Alcohol Abuse
A Trial Investigating the Safety, Tolerability, Pharmacokinetics (the Exposure of the Trial Drug in the Body) and Pharmacodynamics (the Effect of the Investigated Drug on the Body) of Insulin 287 in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate the safety,
      tolerability, pharmacokinetics (the exposure of the trial drug in the body) and
      pharmacodynamics (the effect of the investigated drug on the body) of insulin 287 in subjects
      with type 2 diabetes.
    


Intervention name(s): Insulin icodec; placebo; insulin degludec; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered once weekly subcutaneously (s.c., under the skin) for 35 days; Administered once daily subcutaneously for 35 days; Administered once daily subcutaneously for 35 days; Administered once weekly subcutaneously for 35 days
Other intervention name(s): insulin 287
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment