bioihbjkbjnl/mcl2 huggingface dataset:
Protective Genetic Factors Against Neurological Diseases
Condition: Neurological Disorder; Healthy Control
MeSH terms: Nervous System Diseases
Study type: Observational [Patient Registry]

Summary: 
      NIH Precision Medicine Initiative, started in May 2018, will enroll one million people
      through an online portal. It hopes to identify genetic variants affecting a variety of human
      phenotypic outcomes. A giant set of data like this may enable an association of genetic
      variants with a certain phenotype. However, the association is often compromised due to the
      collection of phenotypic data that is not well controlled or standardized creating "noisy"
      data. These phenotypic "noises" can be largely eliminated in clinical studies with stringent
      criteria and standardization of outcome measurements.

      In this study, by looking mainly at genetic information and nerve conduction speed, we hope
      to eliminate the extra "noises" in the data set. Eliminating the extra "noises" should allow
      us to be able to determine if there are genetic differences between neurological disorders
      and healthy controls, and if these genetic differences can be attributed to the speed of the
      nerve conduction.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Neurology clinic for participants with a diagnosis of a neurological disorder and fliers
        will be posted for healthy controls
      
Biospecimen description: 
      All research participants, including healthy control volunteers, will be asked to give their
      blood samples once they are enrolled into the study. Their DNA will be extracted from the
      blood samples and stored in the freezers at the Integrative Biosciences Center in Detroit,
      MI. All samples stored in the Biobank at iBIO will be frozen and kept for an indefinite
      amount of time. The participant cannot obtain or access the stored samples in the future nor
      will participants have access to information or test results obtained from their personal
      samples because personal identifiers will be removed from the samples.
Determination of Metal Ion Serum Levels and Cytokines in Total Hip Replacement
Condition: Hip Replacement Arthroplasty
Study type: Observational

Summary: 
      The goal of the study is the analysis of metal ion serum concentrations and of the cytokine
      production in the blood of patients with a conventional cementless total hip replacement. The
      rationale is that a) the bearing wear releases particles respectively metal ions into the
      joint and the blood which will differ in quantity and composition; b) the cytokine production
      of peripheral blood mononuclear cells (PBMC) might be influenced to a varying degree by the
      metal and the ceramic particles.

      The patients from whom the respective samples will be analyzed are randomized in one of the
      following three groups: metal-on-metal, ceramic-on-ceramic or ceramic-on-metal. A 36mm
      bearing is used in all patients. In this separate study, follow-up data of the clinical and
      radiographic examinations of the patients are available.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        total of 30 subjects; 10 with metal-on-metal, 10 with ceramic-on-ceramic and 10 with
        ceramic-on-metal hip replacement;
      
Biospecimen description: 
      Blood serum samples for metal ion and cytokine measurement; blood cells for cytokine-RNA
      assessment
    
Keywords: metal; ion; cytokine; hip arthroplasty; blood; Assessment; cytokine profile
A Study to Assess the Safety and Drug Levels of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus
Condition: Lupus Erythematosus, Cutaneous
MeSH terms: Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and drug levels of BMS-986256 in
      participants with cutaneous lupus erythematosus.
    


Intervention name(s): BMS-986256; BMS-986256 Placebo
Intervention type(s): Drug; Other
Intervention description(s): Specified Dose on Specified Days; Specified Dose on Specified Days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A New Intervention for Social Communication Skills Following Brain Injury
Condition: Brain Injuries
MeSH terms: Brain Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      To investigate the effectiveness of a peer-led social skills training intervention compared
      to social activity (usual care) to improve social communication skills following severe brain
      injury.
    

Detailed description: 
      A pilot study first tested the feasibility of the approach and the sensitivity of existing
      outcome measures to changes in group social interaction. Following amendments to the pilot
      protocol, twelve new participants with severe ABI were recruited from a residential
      post-acute rehabilitation centre in April 2015. An experimental parallel group design was
      used to compare a peer-led group intervention to a staff-led social activity group.
      Participants were randomised to a peer-led intervention (n=6) or a staff-led social activity
      group (usual care) (n=6). The groups met twice a week for 8 weeks. A peer with severe ABI was
      trained separately to facilitate interaction in the peer-led group. The training took place
      in 16 individual sessions over 4 weeks. Group behaviour was measured twice at baseline, after
      intervention and at maintenance (4 weeks) using measures meeting reliability, validity and
      responsiveness criteria tested in the pilot study.
    

Intervention name(s): Peer facilitator training; Usual care
Intervention type(s): Behavioral; Other
Intervention description(s): Peer facilitation of a project-based activity without staff present; Staff-led social activity
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: An experimental parallel group design
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Social skills; Social communication; Cognitive communication; Traumatic brain injury; Acquired brain injury; Communication partner training; Peer partner training; Peer mentoring; Rehabilitation
Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum for Advanced NSCLC
Condition: NSCLC
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to explore the Clinical Value of Sequential Gefitinib With
      Pemetrexed/Platinum compare with Pemetrexed/Platinum for Advanced NSCLC.
    

Detailed description: 
      Patients will be randomized to 2 groups
    

Intervention name(s): Sequential Gefitinib With Pemetrexed/Platinum; Pemetrexed/Platinum
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pemetrexed; Gefitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study on the Effect of AB-106 on the Pharmacokinetics of Digoxin
Condition: Solid Tumor
Study type: Interventional
Phase: Phase 1

Summary: 
      AB-106-C111 is China-only study, for investigating the drug interaction between AB-106 and
      P-gp substrate (Digoxin). （n=16）
    


Intervention name(s): AB-106, digoxin
Intervention type(s): Drug
Intervention description(s): Period 1, single dose of 0.25mg digoxin; Period 2, Coadministrate AB-106 600mg and 0.25mg digoxin
Intervention MeSH terms: Digoxin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neuromodulation With rTMS in Dysphagic Patients With Stroke
Condition: Transcranial Magnetic Stimulation
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The patients with chronic dysphagia secondary to first-ever stroke were randomly assigned to
      2 groups: Group A: sham stimulation for 10 minutes , Group B: real rTMS for 10 minutes. rTMS
      conditioning: daily rTMS 10 min for 10 days. Assessments: 1. videofluoroscopy，2.Functional
      outcome swallowing scale (3 scales). 3. MEP measurements
    

Detailed description: 
      While the reﬂex component of swallowing depends on swallowing centres in the brainstem,
      initiation of swallowing is a voluntary action that involves the integrity of motor areas of
      the cerebral cortex. Oropharyngeal dysphagia occurs in more than 50% of stroke patients.
      Aspiration pneumonia occurs in up to 20% of acute stroke patients and is a major cause of
      mortality after discharge. Oropharyngeal dysphagia is both underestimated and underdiagnosed
      as a cause of major nutritional and respiratory complications in stroke patients. Recently,
      transcranial magnetic stimulation (TMS) has been used to study the cortical input to
      swallowing control and has revealed that the topographic representation of esophageal motor
      function in the human cerebral cortex is bilateral but with consistent interhemispheric
      asymmetry unrelated to handedness.

      In a number of recent studies, poststroke motor and dysphagia performance has been improved
      after daily treatment sessions with repetitive TMS (rTMS) using an excitatory frequency in
      patients with hemispheric ischaemic stroke due to occlusion of territories of the middle
      cerebral artery. Our hypothesis was that rTMS would facilitate dysphagia recovery.
    

Intervention name(s): repetitive transcranial magnetic stimulation
Intervention type(s): Device
Intervention description(s): rTMS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dysphagia; Repetitive Transcranial Magnetic Stimulation; Stroke
Fluid Restriction After Stapled Hemorrhoidopexy
Condition: Fluid Restriction
Study type: Interventional

Summary: 
      BACKGROUND: Conventional hemorrhoidectomy leads to a high urinary retention rate and fluid
      restriction is commonly recommended to minimize complications. However, the need for
      postoperative fluid restriction among patients who have undergone stapled hemorrhoidopexy is
      unclear. We aimed to determine whether fluid restriction after stapled hemorrhoidopexy
      with/without partial external hemorrhoidectomy could reduce urinary retention and
      postoperative pain.

      PATIENTS AND METHODS: In this prospective, double-blinded, randomized controlled trial, we
      enrolled patients who had grade III or IV hemorrhoids and underwent stapled hemorrhoidopexy
      with/without partial external hemorrhoidectomy; 250 mL/12 h of sterile 0.9% saline was
      administered to the fluid restriction group after the operation, and 1000 mL/12 h was given
      to the non-fluid-restriction group. We focused on the need for fluid restriction after
      stapled hemorrhoidopexy.
    


Intervention name(s): 1000 mL 0.9% sterile saline; 250 mL 0.9% sterile saline
Intervention type(s): Drug; Drug
Intervention description(s): Within 12 h of surgery, the experimental group received 1000 mL 0.9% sterile saline intravenously.; Within 12 h of surgery, the control group received 250 mL 0.9% sterile saline intravenously.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Stapled hemorrhoidopexy; Fluid restriction; Urinary retention
Osteogenic Effects in Human Mesenchymal Stem Cells Enhanced by Wnt Signaling
Condition: Primary Disease
Study type: Observational

Summary: 
      The first year purpose:

      The best concentration of canonical Wnt3a will be investigated in promoting the
      osteoblastogenesis of human mesenchymal stem cells.
    

Detailed description: 
      Our previous work is investigating the viral (Adv-BMP-2) administration for the development
      of a model to generate bones for possible use in clinical settings; the non-viral and viral
      administrations will be compared for best osteogenesis effects.

      The first year purpose:

      The best concentration of canonical Wnt3a will be investigated in promoting the
      osteoblastogenesis of human mesenchymal stem cells.
    

Sampling method: Non-Probability Sample
Study population: 
        The patients require surgery ner iliac or abdomen areas
Study of Trifarotene Cream to Assess Risk of a Trophic Acne Scar Formation
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of trifarotene 50 microgram
      per gram (mcg/g) cream compared to its vehicle on the risk of formation of atrophic acne
      scars after 24 weeks of treatment in facial acne participants assessed by atrophic acne scars
      count.
    


Intervention name(s): Trifarotene Cream; Trifarotene Vehicle Cream
Intervention type(s): Drug; Drug
Intervention description(s): Participants will apply a thin a layer of trifarotene (CD5789) 50 mcg/g cream to the face once daily, in the evening for 24 weeks; Participants will apply a thin a layer of trifarotene vehicle cream to the face once daily, in the evening for 24 weeks
Other intervention name(s): AKLIEF®
Intervention MeSH terms: Trifarotene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acne vulgaris; Trifarotene; AKLIEF®; CD5789
Efficacy and Safety of Quetiapine in Treating Affective Symptoms of Patients With First-episode psychosis-a Pilot Study
Condition: Schizophrenia
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders; Affective Symptoms
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is:

      To investigate whether a treatment with quetiapine for six months in patients with
      first-episode psychosis may be effective in treating depressive symptoms.

      To investigate whether a treatment with quetiapine for six months in patients with
      first-episode psychosis may be effective in mania-like symptoms and to evaluate the general
      efficacy in psychopathology as well as the safety and tolerability of quetiapine.
    

Detailed description: 
      Affective symptoms, in particular depressive symptoms are prevalent in up to 60% of all
      patients with schizophrenia. However, it is still uncertain whether depressive symptoms have
      a prognostic value, having previously been associated with both favorable and poor outcome.
      In addition, treatment of affective symptoms in patients with schizophrenia is difficult.
      There is some evidence that atypical antipsychotics such as quetiapine may contribute not
      only to a reduction in psychotic symptoms but also that these agents may produce an
      antidepressant effect in schizophrenia and may reduce suicidality. Most of these studies
      suffer from methodological limitations as the efficacy on affective symptoms has not been the
      primary target parameter. Concerning the prevalence of affective symptoms in first-episode
      psychosis knowledge is still poor. This is why we have developed a study design for a
      pilot-study on 60 patients with first-episode schizophrenia aiming to demonstrate that a
      treatment with quetiapine over the period of 6 months shows clinical efficacy on affective,
      particularly depressive symptoms
    

Intervention name(s): Seroquel®
Intervention type(s): Drug
Intervention description(s): dosage form: oral, dosage: 300-800mg/d, frequency: twice daily
Other intervention name(s): Quetiapine
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: quetiapine; schizophrenia; first-episode psychosis; depression; psychopathology
Efficacy of L-Ornithine-L-Aspartate in Cirrhotics With Hepatic Encephalopathy
Condition: Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether L-Ornithine L-Aspartate is effective for
      the improvement of Overt Hepatic Encephalopathy.
    

Detailed description: 
      There is no effective treatment available for hepatic encephalopathy at the moment; therefore
      we aimed to check the efficacy and safety of L-ornithine L-aspartate(LOLA). It provides
      critical substrates for ureagenesis and glutamine synthesis, the two primary mechanisms by
      which the body rids itself of excess ammonia. Ornithine is a specific activator of ornithine
      carbamyl transferase and carbamylphosphate synthetase, and, in addition, is a substrate for
      ureagenesis. These reactions are carried out mainly in the periportal portion of the hepatic
      lobules. Aspartate and ornithine, after conversion to alfa-ketoglutarate, are substrates for
      glutamine synthesis, which is performed exclusively by a small population of perivenous
      hepatocytes, the so-called perivenous scavenger cells. The ammonia lowering effect resulting
      from the stimulation of these two basic mechanisms of ammonia detoxification has been studied
      in animals and was confirmed in humans in clinical trials.
    

Intervention name(s): L-Ornithine L-Aspartate
Intervention type(s): Drug
Intervention MeSH terms: N-Methylaspartate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: L-ornithine-L-aspartate,; porto-systemic encephalopathy,; hepatic encephalopathy,; liver cirrhosis,; mental state
A Study to Evaluate Participant Satisfaction With Facial Appearance Overall and the Aesthetic and Psychosocial Impact of Combined Facial Treatment
Condition: Facial Rhytides, Skin Folds, Loss of Volume and Skin Quality
MeSH terms: Facies
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to quantify the psychological and emotional impact of
      comprehensive aesthetic treatment with a portfolio of Allergan products by measuring the
      change in participant's satisfaction with facial appearance from baseline to the final study
      visit.
    


Intervention name(s): JUVÉDERM®; BOTOX Cosmetic®; BELKYRA®; SkinMedica
Intervention type(s): Device; Drug; Drug; Other
Intervention description(s): Facial filler injection (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8 (BELKYRA Treatment) and Month 0 to Month 2 (Non-BELKYRA Treatment).; BOTOX Cosmetic, 20 U to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U injected to forehead lines at Month 9 and Month 10 (BELKYRA Treatment) and at Month 3 and Month 4 (Non-BELKYRA Treatment).; BELKYRA, subcutaneous injection for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose = 100 mg (10mL).; SkinMedica products (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11 (BELKYRA Treatment) and Month 0 to Month 5 (Non-BELKYRA Treatment).
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Randomized Trial of Three Regimens to Prevent Tuberculosis in HIV-Infected Patients With Anergy
Condition: HIV Infections; Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 4

Summary: 
      INTRODUCTION. To evaluate the efficacy of three regimens of prophylactic therapy for
      tuberculosis in HIV-infected patients with anergy. METHODS. Prospective, multi-center,
      randomized, comparative, and open clinical trial. Anergy was defined as absence of induration
      in response to three antigens (PPD, Candida albicans and parotiditis antigen) applied by the
      Mantoux method. Patients were randomized into one of the following prophylactic treatment
      groups: isoniazid for six months (6H), rifampin plus isoniazid for three months (3RH),
      rifampin plus pyrazinamide for two months (2RZ) or no treatment (NT). After completion of
      treatment, patients were followed up for two years.
    

Detailed description: 
      This study is a controlled, open, randomized, multi-center clinical trial. The study was
      authorized by the Clinical Research Ethics Committee of all participating centers and
      informed written consent was obtained from all the patients included. The cutaneous anergy
      was defined by the absence of a reaction (0 mm) to skin reactivity tests with tuberculin,
      Candida albicans, and parotiditis antigens 72 hours after inoculation. The patients were
      randomzed into one of the following four groups: isoniazid for 6 months (6H), rifampin plus
      isoniazid for 3 months (3RH), rifampin plus pyrazinamide for 2 months (2RZ) or no treatment
      (NT). All of the participating subjects underwent a basal study that included clinical and
      epidemiological history, chest x-ray, hemogram, analysis of serum creatinine concentrations,
      uric acid, AST, ALT, alkaline phosphatase, and total bilirubin, as well as a CD4+
      T-lymphocyte count.During prophylactic treatment, patients were evaluated every 15 days for
      the first two months and monthly thereafter. At each check-up it was determined whether or
      not the patient was following the treatment properly and whether there were any adverse
      effects. Therapeutic completion was defined as taking at least 80% of the total prescribed
      dosages.Chemoprophylaxis was discontinued whenever a patient requested to do so or for any of
      the following reasons: appearance of Grade 3 or 4 side effects that could be attributed to
      the drugs used in the study; increases in AST and/or ALT values of three times or more their
      basal values; development of TB; or diagnosis of any disease that made interruption of the
      treatment advisable.
    

Intervention name(s): isoniazid, rifampin + isoniazid, rifampin + pyrazinamide or not treatment
Intervention type(s): Drug
Intervention MeSH terms: Rifampin; Isoniazid; Pyrazinamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV; Tuberculosis; Chemoprophylaxis; Anergy; AIDS
Tolerability and Safety of BDB-001 Injection in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical study to evaluate the tolerability, PK and PD characteristics of BDB-001 Injection
      in healthy subjects.
    


Intervention name(s): BDB-001 injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous injection; Intravenous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment