bioihbjkbjnl/mcl2 huggingface dataset:
Follow-up Study of Chondrogen® Delivered by Intra-Articular Injection Following Meniscectomy
Condition: Recovery Following Partial Medial Meniscectomy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of the present study is to establish the long-term safety of an intra-articular
      injection of human mesenchymal stem cells (hMSCs) (Chondrogen).
    

Detailed description: 
      The long-term safety of human mesenchymal stem cells (hMSCs) (Chondrogen) has not yet been
      established. This 3-year follow-up study will provide additional data to gain understanding
      of the safety of the investigational agent. This study is designed to determine the safety of
      a single intra-articular injection of 50 million donor-derived hMSCs or 150 million
      donor-derived hMSCs in suspension with commercial sodium hyaluronan compared to an injection
      of vehicle (diluted hyaluronan) alone. The injections were performed under the initial study,
      Protocol No. 550.
    

Intervention name(s): Chondrogen; Chondrogen; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intra-articular injection of ex vivo cultured adult human mesenchymal stem cells; Intra-articular injection of ex vivo cultured adult human mesenchymal stem cells; Intra-articular injection of Hyaluronan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee; Meniscus; Meniscectomy; Mesenchymal Stem Cells; MSCs; Adult Human Stem Cells; Osiris; Chondrogen
Implementation of a Program Based on Adapted Physical Activity and Recommendations for Second Cancers Prevention for TYACs
Condition: Neoplasms
MeSH terms: Neoplasms, Second Primary
Study type: Interventional

Summary: 
      About 700 new cases of cancer are recorded each year among TYAC aged 15 to 25 years old in
      Rhône-Alpes region (France); more than 200 are treated and supported within the TYAC
      Department of the Institute of Hematology and Oncology Pediatrics (Centre Léon Bérard-Civil
      Hospice of Lyon). These patients survive from their disease in 80% of cases; they have six
      times more likely to develop a risk of second primary cancer (SCP) than their peers. This
      risk of SCP is multifactorial and varies depending on the type of first cancer, treatment
      received and the prevalence of risk factors (smoking, overweight, sedentary lifestyle,
      environmental exposures...). This project aims to implement a clinical program based on
      adapted physical activity (APA) and cancer prevention recommendations for TYAC during the
      active treatment period (4-6 months). The methodology used series of assessments of APA
      sessions and information meetings dedicated to cancer prevention and SCP risk
      recommendations. It mobilizes regularly the health care team of TYAC Department, TYAC
      associations, sports structures and associations involved in cancer prevention at the
      regional level. Assessment of TYAC satisfaction regarding the project, benefits in terms of
      exercise practice, and knowledge improvement on cancer prevention recommendations, are
      assessed throughout the program.
    


Intervention name(s): Physical activity program and prevention after cancer
Intervention type(s): Other
Intervention description(s): Providing a supervised and non-supervised physical activity program for adolescent and Young adult with cancer and improve awareness on cancer prevention recommendations (second cancer risk, healthy lifestyles...)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adolescent and young adult
Point of Care Device Use in the Pediatric Emergency Department
Condition: Dehydration; Seizure; Gastroenteritis; Hyperglycemia
MeSH terms: Gastroenteritis; Seizures; Hyperglycemia; Dehydration; Emergencies
Study type: Interventional

Summary: 
      To compare the effect of "point-of-care" (POC) analysis of blood work with traditional
      laboratory methods on length of stay in a pediatric emergency department (PED).
    

Detailed description: 
      This study was a prospective, randomized controlled study of patients requiring blood work
      that a POC device was capable of performing. Length of time spent at various timepoints were
      prospectively recorded by a dedicated research assistant after randomization.
    

Intervention name(s): Point of Care Device; i-Stat Analyzer
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Point-of-care Testing; Pediatric Emergency Department; Length of Stay; Efficiency
N-Acetyl Cysteine in the Prevention of Contrast Induced Nephropathy in Cirrhosis of Liver-NEPHRO Trial
Condition: Liver Cirrhoses
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional

Summary: 
      Contrast induced nephropathy has an incidence of 7-11 % in patients undergoing Contrast
      imaging for various conditions. The risk associated with the development of CIN are still
      under evaluation. Even with patients having normal kidney functions there is a risk of
      contrast induced nephropathy hence the need for markers which could predict injury. Cirrhosis
      of liver predisposes patient to Kidney abnormalities as these patients lower renal reserve
      and can have various conditions like Hepatorenal syndrome, Sepsis, ATN. Contrast imaging is
      vital for ruling out conditions like Hepatocellular Carcinoma in patients of cirrhosis of
      liver. Presently there is no study in cirrhosis of liver which studies the Effect of N-acetyl
      cysteine before and after contrast imaging in the prevention Of CIN. The incidence of CNI is
      cirrhosis is also an avenue which requires more studies and also there is a need for
      formulation of a Score to predict this CIN. Hence this study is being done to assess the
      incidence of CNI and the role of N-Acetyl cysteine in Preventing CNI.
    


Intervention name(s): N-Acetyl Cysteine; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): NAC 1200 mg twice daily one day prior to the procedure and on the day of the procedure.; Placebo Oral Tablet twice daily.
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
68Ga-AlfatideII for the Differential Diagnosis of of Lung Cancer and Lung Tuberculosis by PET/CT
Condition: Lung Cancer; Lung Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary; Lung Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Comparison of 68Ga-AlfatideII and 18F-FDG in differential diagnosis effectiveness towards the
      solitary pulmonary nodules of lung cancer or tuberculosis.
    


Intervention name(s): 68Ga-labeled peptides of dimer RGD (Alfatide II) and 18F-FDG
Intervention type(s): Radiation
Intervention MeSH terms: Fluorodeoxyglucose F18
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 68Ga; Alfatide II; RGD; αvβ3; PET/CT
A Study of Adalimumab to Treat Sarcoidosis of the Skin
Condition: Sarcoidosis
MeSH terms: Sarcoidosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if adalimumab is an effective for the skin
      manifestations of sarcoidosis.
    

Detailed description: 
      The cutaneous lesions of sarcoidosis are often disfiguring and can produce functional
      impairment. They tend to be hard to treat with most topical therapies and often require
      systemic medications which carry the risk of significant side effects. Often such treatments
      are withheld unless there is a need to use them for visceral involvement. There is thus an
      unmet need for safe and effective treatments for these patients. In addition there is
      essentially no controlled trial data for any treatments for cutaneous sarcoidosis. This study
      is intended to determine if adalimumab might offer a viable therapeutic option for this
      condition by comparing the response of cutaneous sarcoid lesions to this drug as compared to
      placebo.
    

Intervention name(s): adalimumab
Intervention type(s): Drug
Intervention description(s): Adalimumab 40 mg administered subcutaneously once weekly or placebo injection administered once weekly for 12 weeks, followed by open-label adalimumab 40 mg administered subcutaneously weekly for an additional 12 weeks.
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sarcoidosis; adalimumab; skin diseases
Role of Herbal Immunomodulators in the Treatment of Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Addition of systemic herbal immunomodulators with scaling & root planing (SRP) may enhance
      the therapeutic result of Chronic Periodontitis owing to host modulation & anti-inflammatory
      properties. If proven, herbal immunomodulators can be used as an adjunct to SRP.
    


Intervention name(s): herbal immunomodulator; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients in Test Group were treated with scaling and root planing (SRP) along with Herbal Immunomodulators (Septilin) therapy, 2 tablets twice daily for 3 weeks.; Patients in Control Group were treated with scaling and root planing (SRP) along with Placebo therapy, 2 tablets twice daily for 3 weeks.
Other intervention name(s): Septilin (brand name)
Intervention MeSH terms: Immunologic Factors; Adjuvants, Immunologic; Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Herbal medicine,; Host modulation therapy,; Periodontitis,; Meta-analysis,; Scaling and root planing.
A Study to Investigate the Mass Balance of BTD-001
Condition: Molecular Mechanisms of Pharmacological Action
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-centre, open-label, non-randomised, single oral dose study in healthy male
      subjects to assess the mass balance recovery of carbon-14 (14C)-BTD-001.
    


Intervention name(s): [14C]-BTD-001
Intervention type(s): Drug
Intervention description(s): Carbon-14 labeled BTD-001
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Mass Balance; Phase 1
Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE2)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, randomized, double-blind, placebo-controlled study to be conducted in
      the United States in subjects with atopic dermatitis.
    


Intervention name(s): Tradipitant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BID; BID
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Pruritus; Eczema
Performance of the Hedrocel(R) Cervical Fusion Device
Condition: Symptomatic Cervical Disc Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this clinical investigation is to compare patients treated with Anterior
      Cervical Discectomy and Fusion (ACDF) using the Hedrocel Cervical Fusion Device, with a
      concurrent, randomized, control group receiving autologous iliac crest bone graft or
      allograft and test the hypothesis that ACDF with Hedrocel is non-inferior to ACDF with
      allograft or autologous bone graft.
    

Detailed description: 
      The objective of this clinical investigation is to compare patients treated with Anterior
      Cervical Discectomy and Fusion (ACDF) using the Hedrocel Cervical Fusion Device, with a
      concurrent, randomized, control group receiving autologous iliac crest bone graft. Success
      criteria include radiographic evidence of fusion, and improvement in pain, function and
      overall quality of life. If shown to be successful, the use of the Hedrocel Cervical Fusion
      Device would eliminate complications associated with harvesting autologous bone graft and
      provide an alternative for those who are unable to provide autologous bone graft from the
      iliac crest.
    

Intervention name(s): Anterior Cervical Discectomy and Fusion; Anterior Cervical Discectomy and Fusion; Anterior Cervical Discectomy and Fusion
Intervention type(s): Device; Device; Device
Intervention description(s): Implantation of Hedrocel; Implantation of Allograft; Implantation of Autograft
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Anterior Cervical Discectomy and Fusion,; Degenerative Disc Disease,; Cervical Spine,; Herniated Disc
Effect of MMFS-202-302 on Cognitive Enhancement in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The goals of this study are to study MMFS-202-302 in a double blind, randomized,
      placebo-controlled 9-week study of its effect on ameliorating cognitive deficits in 60
      patients with schizophrenia or schizoaffective disorder with stable levels of positive
      symptoms. Secondary end points will include changes in positive and negative symptoms. One
      dose of MMFS-202-302 will be studied and compared with placebo as adjunctive treatment to
      atypical antipsychotic drug treatment.
    

Detailed description: 
      One of the symptoms of schizophrenia is a problem with specific domains of cognition, even
      when the positive symptoms have been treated. The primary goal of this study is to determine
      the effectiveness of 9 weeks of supplementation with MMFS-202-302 as augmentation of atypical
      antipsychotic medication, to improve a critical specific domain of cognitive function, i.e.,
      working memory, in patients with schizophrenia or schizoaffective disorder. To support this
      primary goal, global function will be assessed with the Clinical Global Impression assessment
      of change.

      The investigators will also examine the effect of MMFS-202-302 on other domains of cognition
      (e.g. attention, executive function, declarative memory, etc.); negative symptoms of
      schizophrenia; positive symptoms of schizophrenia; MRI measures of brain structure, resting
      state functional connectivity, and function during evaluation of emotional/unemotional and
      rewarding/aversive images and anticipation and receipt of reward and punishment, and working
      memory; and EEG measurement of network interactivity during learning and memory recollection.
    

Intervention name(s): MMFS-202-302; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active ingredient: L-Threonic acid Magnesium salt.
1 g (2 pills) by mouth once daily in the evening for 9 weeks
Drug: MMFS-302 Active ingredient: L-Threonic Acid Magnesium Salt
1 g (2 pills) by mouth once daily in the morning for 9 weeks; Two tablets by mouth in the morning, and two tablets by mouth in the evening, daily for 9 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Schizoaffective disorder; Cognition; Magnesium; Imaging; Negative symptoms
Pharmacokinetics and Bioavailability Comparison of Two Different Formulations of MNTX Tablets
Condition: Normal Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a single-center, double-blind, randomized, cross-over Phase 1 study in normal,
      healthy volunteers. Study treatment entailed single doses of two different formulations of
      MNTX tablets.
    


Intervention name(s): MNTX tablet (Formulation 1); MNTX tablet (Formulation 2)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Methylnaltrexone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Analysis of Change of Optic Nerve Sheath Diameter in in Patients Operated for Urological Reasons
Condition: Anaesthetic Complication Neurological; Central Nervous System Depression
MeSH terms: Depression
Study type: Observational

Summary: 
      The assessment of the diameter of the optic nerve sheath (ONSD) using ultrasound can be a
      very helpful tool in the assessment of increased intracranial pressure in patients operated
      for urological procedures.
    

Detailed description: 
      Advantages of using ultrasound in the assessment of intracranial pressure:

      simple, bedside examination, repetitive, generally available, cheap, no exposure to X-rays,
      no need to transport the patient to the CT laboratory

      Differential diagnosis:

      Widening of the size of the optic nerve sheath outside of increased intracranial pressure may
      occur in the following pathologies:

      optic neuritis optic nerve injuries meningioma of the optic nerve arachnoid cyst around the
      optic nerve tumors of the cavernous sinus Blood edema may occur due to impaired blood flow.
      The research is to determine whether the patient's position for urological procedures is safe
      for the patients and whether as a result of staying in such a position there is no
      development of cerebral edema.
    

Intervention name(s): Change of Optic Nerve Sheath Diameter
Intervention type(s): Diagnostic Test
Intervention description(s): In patients, the optic nerve sheath width (ONSD) examination will be performed twice: for the first time immediately after general anesthesia and again after surgery after placing the patient in a position on the back.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing urologic operation Adults 18 to 90 years of age American Society of
        Anesthesiologists Physical grade 1-3
      
Keywords: Optic Nerve Sheath Diameter; Urological Anaesthesia; point of care USG
Study to Investigate the Safety and Tolerability of AZD8848 in Butyrylcholinesterase Deficient Subjects
Condition: Butyrylcholinesterase Deficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of AZD8848 in
      Butyrylcholinesterase deficient subjects in comparison with sex and age matched control
      subjects.
    

Detailed description: 
      An Open, Non-controlled, Non-randomised, Parallel-group Study to Investigate the Safety,
      Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of AZD 8848
      Administered Intranasally to Male and Female Butyrylcholinesterase deficient Subjects and to
      Sex and Age matched Controls
    

Intervention name(s): AZD8848
Intervention type(s): Drug
Intervention description(s): Nasal spray solution, intranasal, single ascending doses, 1.4 - 60 μg
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Butyrylcholinesterase deficiency; tolerability; safety; AZD8848; pharmacokinetics; pharmacodynamics; BChE deficient subjects and matched control subject
Reletex Versus Standard of Care Therapy for Post-Operative Nausea Control in Patients Undergoing Foregut Surgery
Condition: Nausea and Vomiting Post-foregut Surgery
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      The effect a ReletexTM device has on postoperative nausea and vomiting when used with
      ondansetron after foregut surgery will be studied. A ReletexTM device is a FDA approved
      wristwatch-like device that painlessly stimulates a nerve in the wrist and has been shown to
      decrease nausea and vomiting. The investigators will randomize 100 patients who are having a
      fundoplication for either gastroesophageal reflux disease (GERD), paraesophageal hernia, or
      Heller Myotomy for achalasia into two groups. A control group will receive scheduled
      ondansetron for prevention and treatment of postoperative nausea and vomiting and phenergan
      as needed. The treatment group will wear a ReletexTM wrist band after surgery for 7 days.
      These patients will also get scheduled ondansetron and phenergan as needed, like the control
      group. The investigators will compare nausea, retching, and the amount of supplemental nausea
      medication used between the two groups. The patients will be provided a diary to document
      their nausea, retching, and medication use.

      The hypothesis of this study is that use of the ReletexTM device will reduce post-operative
      nausea and vomiting, and will reduce post-operative use of anti-emetic medications in
      patients who have undergone foregut surgery.
    


Intervention name(s): Reletex; IV ondansetron 4 mg q 6 hours for a total of 4 doses; IV promethazine 25 mg q 6 hours prn; Elixir promethazine 25 mg q 6 hours prn after discharge
Intervention type(s): Device; Drug; Drug; Drug
Intervention description(s): Neurostimulation device for prevention/treatment of post-operative nausea and vomiting, Reletex arm.
Intervention MeSH terms: Promethazine; Diphenhydramine; Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: nausea; vomiting; post-operative; foregut surgery
Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants
Condition: Ductus Arteriosus, Patent
MeSH terms: Ductus Arteriosus, Patent
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine if adding paracetamol to ibuprofen is superior to
      ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.
    

Detailed description: 
      Randomized control trial to determine if adding paracetamol to ibuprofen is superior to
      ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.
    

Intervention name(s): Paracetamol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ibuprofen 3 doses administered q24h + Paracetamol 12 doses administered q 6h; Ibuprofen 3 doses administered q24h + Placebo : 12 doses administered q 6h
Other intervention name(s): Acetaminophen; Acamol; NaCl 0.9%
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: patent ductus arteriosus; PDA; Preterm; Infant; Electrocardiography; Paracetamol; Acamol; ibuprofen; Placebo
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicef 300 mg Capsule Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fasting
      conditions.
    


Intervention name(s): Cefdinir 300 mg Capsule (Sandoz, Austria); Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cefdinir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antibiotic