bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate Pharmacokinetic and Safety of Albuvirtide Between Intravenous Drip and Intravenous Injection
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center,randomized,open, single-dose, parallel-design study, which will be
      only enrolled Chinese healthy volunteers.
    

Detailed description: 
      30 Chinese volunteers will be enrolled to assess the pharmacokinetic and safety of
      Albuvirtide in two different Administration methods. All subjects are required to collect PK
      blood samples before and after administration.

      30 healthy subjects will be randomized into three cohorts ( cohorts A, B and C) in 1:1:1
      ratio, with 10 subjects in each cohort. The subjects will receive a single dose of 320 mg of
      albuvirtide by iv infusion for 45 min or by iv bolus for 0.5 min or 3 min, respectively.
    

Intervention name(s): Albuvirtide
Intervention type(s): Drug
Intervention description(s): Long-Acting HIV-1 Fusion Inhibitor (chemically modified peptide targeting HIV-1 gp41)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Dose Response Study of a Topical Formulation of Nitroglycerin for the Treatment of Raynaud's Phenomenon
Condition: Raynaud's Disease
MeSH terms: Raynaud Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this clinical study is to determine the response to two different dosage
      strengths of a topical nitroglycerin gel in patients with Raynaud's Phenomenon. Patient
      fingers will be monitored for changes in blood flow and skin temperature. Symptoms of pain,
      tingling and numbness will also be monitored.
    

Detailed description: 
      It is the intention of this protocol to study, in a controlled manner, the response of
      fingers of patients with Raynaud's phenomenon to two dosage strengths of a fast acting
      topical formulation of Nitroglycerin, MQX-503. Patients may have moderate to severe primary
      Raynaud's phenomenon or Raynaud's phenomenon secondary to autoimmune diseases such as
      scleroderma.

      Quantitative changes in blood flow in the fingers of the non-dominant hand will be measured
      after the clinical induction of constriction of blood vessels by exposure to local cold
      temperatures. Secondarily, the quantitative reduction in skin temperature recovery time and
      symptoms of pain, tingling and numbness associated with Raynaud's phenomenon will be
      evaluated using a patient hand symptom analog assessment score. The frequency and severity of
      adverse events associated with MQX-503 will be assessed.
    

Intervention name(s): Nitroglycerin
Intervention type(s): Drug
Intervention MeSH terms: Nitroglycerin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Raynaud's phenomenon; Raynaud's Disease; Raynaud's disease secondary to scleroderma; Raynaud's phenomenon secondary to autoimmune disease
Non-Invasive Determination of Cardiac Output by Inertgas Rebreathing Method
Condition: Cardiac Diseases
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      The cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac
      diseases. The current standard methods for the determination of the CO, however, are either
      invasive (e.g. right heart catheterization) or technically expendable and expensive (magnetic
      resonance tomography, MRT). The traditional non-invasive methods of determining the CO by
      rebreathing of carbon dioxide are easily carried out but suffer from methodical inaccuracies.
      Therefore the aim of the study at hand was to evaluate a new method for determining the CO by
      means of the inert gas rebreathing method.
    


Intervention name(s): inertgas rebreathing; spirometry; cardiac magnetic resonance imaging (CMR)
Intervention type(s): Device; Device; Device
Intervention description(s): determination of cardiac output by inertgas rebreathing; spirometry for testing the ventilatory function; CMR examination which delivers the hemodynamic reference parameters
Observational model: Cohort
Time perspective: Prospective
Study population: 
        Consecutive patients with indication for CMR
      
Keywords: indication for CMR
Study to Evaluate Benefits & Safety of Endourage Formula C™ Oral Drops in People With Post-Acute COVID-19 Syndrome.
Condition: Covid 19
MeSH terms: COVID-19; Post-Acute COVID-19 Syndrome
Study type: Interventional

Summary: 
      This study will explore the contribution of CBD oral drops in persons experiencing symptoms
      of Post Acute COVID Syndrome or "PACS".
    

Detailed description: 
      At present, conventional medical and rehabilitation therapies have not consistently been
      effective for people with PACS, and in fact some symptoms have been observed to worsen over
      time. This inconsistency in clinical response has created a need for alternative treatment
      options to be explored. CBD presents a novel approach that warrants further investigation.

      After review and approval by an Institutional Review Board (IRB), potential study
      participants will be recruited from on-line support groups who have identified themselves as
      persons experiencing post-acute COVID-19 syndrome also known as (long-haulers syndrome).

      The study will be registered on the www.clincaltrials.gov website and will accept referrals
      from targeted clinics who refer their patients to the investigational site listed and
      individuals can also self-refer to the study center team.

      Subjects will be evaluated weekly using telemedicine procedures. At completion of study,
      there will be a 7-day and 14-day follow up telemedicine visit to assess for continued benefit
      and/or re-emergence of symptoms/relapse.
    

Intervention name(s): Targeted Wellness Formula C™ Sublingual Drops - 1200mg - 30 mL (Formula C)
Intervention type(s): Dietary Supplement
Intervention description(s): Hemp seed oil
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A total of 60 (sixty) participants who meet inclusion and exclusion criteria will be randomized and enrolled in a 1:1 ratio of study product (Formula C) vs. placebo.
Group 1: 30 participants will be randomized to masked active study product (Formula C) for 28-days; they will continue to the open label extension phase (with commercially available product for an additional 28-days when they will receive commercially available product.
Group 2: 30 participants will be randomized to placebo for 28-days; they will roll-over to the open label extension phase of study product (Formula C) for an additional 28-days when they will receive commercially available product.
At the completion of the treatment period, the participants will be followed for 14-days.
Masking: Single (Participant)
Primary purpose: Other
Impact of Fatigue on Jumping Performance
Condition: Healthy
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The purpose of this study will be to determine the effects of a 2-minute single limb lateral
      step-down fatigue test versus a 30 second side hop test on single limb forward hop distance.
    

Detailed description: 
      Current methods to induce fatigue often incorporate equipment not available in all clinical
      settings or include tasks that are difficult to standardize. One of the tests to fatigue the
      leg muscles is the leg extensor fatigue test using a unilateral weight machine. There are
      drawbacks to this testing including the clinician having access to the equipment, testing
      only fatigued a single muscle group, and it is less sport/task specific compared to jump
      testing. Our previous work has incorporated the use of a side hop task that is performed by
      hopping over two lines 40 cm apart for 30 seconds. While this does induce fatigue and
      decreases single leg forward hop performance the overall decrease was relatively small (<10
      cm). It is likely necessary to induce a greater amount of fatigue; thus further limiting
      single leg forward hop performance.
    

Intervention name(s): Step-Down Test (2 min); Side hop test (30 s)
Intervention type(s): Other; Other
Intervention description(s): The 2-minute single limb lateral-step down test will be used to induce lower extremity muscle fatigue. Participants will be instructed to perform a single limb lateral step-down test on a 31 cm box (12-inches), touching their heel to the floor each time as many times as possible in 2 minutes. The number of lateral step-downs will be recorded.; The 30 second side hop test will be used to induce lower extremity muscle fatigue. Participants will be instructed to jump as many times as possible over two parallel strips of tape placed 40 cm apart, but must initiate approximately 30 degrees of knee flexion each jump. The number of successful jumps performed within 30 seconds will be recorded and used for data analysis. An unsuccessful jump will be defined as touching the tape or the area inside the tape. We will record the number of successful trials.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Side Hop; Forward Hop; Step test; Vertical Jump
Safety Evaluation of the LGL102 in Obese Subjects Treated With OMS102
Condition: Obesity; Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      The main objective of this study is to evaluate the LGL102 implant safety in obese to
      morbidly obese subjects treated with OMS102 system. The effect of the therapy on body weight
      changes will be also evaluated.
    


Intervention name(s): OMS102
Intervention type(s): Device
Intervention description(s): Subjects will receive implanted OMS102 System.
Other intervention name(s): abiliti System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; gastric stimulation; morbid obesity
Phase II Clinical Trial of Purified Isoflavones in Prostate Cancer: Comparing Safety, Effectiveness
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of our study is to recruit and treat 96 men diagnosed with prostate cancer and
      scheduled for a prostatectomy with a capsule form of either purified isoflavones or placebo
      for a 3-6 week period to see if we can slow down the rate of prostate cancer growth. A
      placebo is a pill or something that looks like the medicine that is being studied but has no
      active medicine in it. We also want to see if taking purified isoflavones is safe and if it
      reduces lower urinary tract symptoms. In addition, we want to study if purified isoflavones
      are able to slow the progression of prostate cancer, and the mechanism of action of purified
      isoflavones. If the safety and the effects of purified isoflavones on slowing down the
      progression of prostate cancer is shown in our study, this will also be a safe way of
      treating men who are at high risk of prostate cancer, so that we can prevent prostate cancer
      in the future.
    

Detailed description: 
      Patients will need to take two (2) capsules daily, one with their breakfast and one with
      their dinner. On the day prior or the day that patients are coming in for their pre-operative
      surgery blood work, we ask that they take the second dose with lunch, if their appointment is
      in the afternoon.

      At the start of the study and at the end of the study (3-6 weeks), patients will undergo
      interviews, complete questionnaires, and have lab tests to determine if this drug is
      effective to reduce progression of prostate cancer and is safe to use.

      Patients will also receive a multivitamin/mineral supplement for the 3-6 weeks that they are
      on this study and will be required to take one (1) every day. It is required that patients
      not take any other vitamin/mineral or herbal preparation containing isoflavones and avoid
      eating or drinking soy products.

      We anticipate that most patients will be scheduled for a prostatectomy 3-6 weeks (+/- 3 days)
      from start of study agent. In addition to their first visit, patients will be required to
      come in the day of the surgery for prostatectomy.
    

Intervention name(s): Purified isoflavones; Methyl cellulose blend
Intervention type(s): Drug; Drug
Intervention description(s): Soy-based isoflavone concentrate with methyl cellulose blend filler - Take 2 capsules daily; Placebo - Take 2 capsules daily
Other intervention name(s): Novasoy 400; Avicel PH105; Avicel PH105
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study Evaluating the Impact of an Educational Program (EDU-MICI) on Patients With Inflammatory Bowel Disease
Condition: Crohn's Disease; Ulcerative Colitis
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      This study has the objective to demonstrate that an education program could have a
      significant impact on Inflammatory Bowel Disease (IBD) patient's skills with regards to their
      disease.
    


Intervention name(s): Educational program EDU-MICI
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Crohn's Disease; Ulcerative Colitis; Educational program; Inflammatory Bowel Disease; Psycho-pedagogic score; IBD
Efficacy of Telerehabilitation in the Patients With Aphasia
Condition: Aphasia
MeSH terms: Aphasia
Study type: Interventional

Summary: 
      The study will invite 30 patients to join, and they will be arranged in the face to face
      group and telerehabilitation group randomly.

      In the telerehabilitation group, the investigators use the mobile device, which with the
      camera and speaker, for patients to practice the naming training at home, and assess the
      speech ability every 2-4weeks by speech therapist via telerehabilitation platform.

      Concise Chinese Aphasia Test (CCAT) and ASHA FACS conceptual framework Test will be used as
      the assessment tool for evaluation speech ability and functional ability.

      The investigators expect that patients can improve their speech ability, functional ability,
      and quality of life via telerehabilitation speech therapy.

      And the investigators can establish the standard telerehabilitation speech therapy protocol
      for aphasia therapy.
    


Intervention name(s): Smart Phone Based Assistive Speech Therapeutic System; Mobile phone-based tele rehabilitation program
Intervention type(s): Procedure; Procedure
Intervention description(s): use the mobile device, which with the camera and speaker, for patients to practice the naming training at home, and assess the speech ability every 2-4weeks by speech therapist via telerehabilitation platform. Concise Chinese Aphasia Test (CCAT) will be used as the assessment tool for evaluation speech ability and functional ability.; Mobile phone-based tele rehabilitation program
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: telerehabilitation; aphasia; speech therapy; rehabilitation device; visual action therapy; naming drills
Saroglitazar Magnesium in the Treatment of Non-Alcoholic Steatohepatitis
Condition: Non Alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled study to evaluate safety and efficacy
      of Saroglitazar Magnesium 2 mg and 4 mg in patients with NASH. This study will be initiated
      after obtaining the approvals of Institutional Ethics Committee/Institutional Review Board
      (IEC/IRB) and the local regulatory authority.
    

Detailed description: 
      Patients clinically suspected of NASH will be invited for a screening programme for inclusion
      in the study. Patients will be screened according to the inclusion and exclusion criteria.
      Clinical evaluation will be conducted for baseline characteristics and anthropometry
      measurements such as body weight and height.

      After clinical evaluations, all baseline safety and efficacy parameters will be recorded as
      per Visit Schedule. All laboratory collections will be performed following overnight fasting
      (at least 8 hrs).

      Following confirmation of all clinical and laboratory inclusion and exclusion criteria,
      patients will continue into the screening period. During the screening period liver biopsy
      will be performed. However, if a biopsy was performed within 6 months the slides and biopsy
      material, or block, must be made available for baseline documentation. Such Patients, whose
      historical biopsy report is available, should not use medication suspected of having an
      effect on NASH from the 3 months prior to the screening.

      Liver biopsy will be performed to confirm the diagnosis of NASH and record a baseline NAFLD
      Activity Score. The histological evidence of NASH is defined as NAS ≥ 4 with a minimum score
      of 1 for all of its three components [steatosis, hepatocyte ballooning and lobular
      inflammation].

      Following confirmation of inclusion/exclusion criteria and upon histological confirmation of
      NASH by liver biopsy, patients will be enrolled into the study.

      Eligible patients will be randomly assigned to receive Saroglitazar Magnesium 2 mg or 4 mg or
      placebo in a 2:2:1 ratio for 24 weeks.

      Upon completion of 24 weeks of treatment, liver biopsy will be performed and the NAFLD
      Activity Score recorded.
    

Intervention name(s): Saroglitazar Magnesium 2mg; Saroglitazar Magnesium 4mg; Placebos
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients randomly assigned to this group will receive Saroglitazar Magnesium 2 mg tablet orally once daily for 24 weeks.; Patients randomly assigned to this group will receive Saroglitazar Magnesium 4 mg tablet orally once daily for 24 weeks.; Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NASH
Light to Maximize Vision, Minimize Insomnia
Condition: Postural Balance
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether specific wavelengths of light at night can
      be used to improve mobile balance while simultaneously not increasing alertness.
    


Intervention name(s): Light
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Phase 2 Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia; Cognition Disorders; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an efficacy study evaluating a experimental treatment for cognitive deficits in
      adults with schizophrenia.
    

Detailed description: 
      Safety and Efficacy Study for Cognitive Deficits in Adult Subjects with Schizophrenia.
    

Intervention name(s): ABT-126; ABT-126; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ABT-126 Low Dose; ABT-126 High Dose; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: schizophrenia
LatInamerican Vaccine Effectiveness Against Hospitalizations Due to Circulating COVID-19 VoC RWE Study
Condition: COVID-19, SARS-CoV-2
MeSH terms: COVID-19
Study type: Observational

Summary: 
      COVID-19 is the infectious disease caused by the novel coronavirus known as SARS-CoV-2, that
      appeared in 2019. The World Health Organisation (WHO) declared the novel coronavirus a
      pandemic on 11 March 2020. The evolution of the pandemic is varying across countries,
      affected in part by different containment strategies ranging from extreme lockdown to
      relative inaction. As a result, there are regional waves of the disease and pockets of
      vulnerable populations. Globally, governments have acknowledged that effective vaccines
      against COVID-19 are the only way to guarantee a safe and sustained exit strategy from
      repeated lockdowns.

      The objective of this study is to estimate the vaccine effectiveness against hospitalizations
      due to circulating COVID-19 VoC among subjects eligible for vaccination with the AstraZeneca
      or any other COVID-19 vaccine provided in their country as per national/regional immunization
      recommendations prior to hospital admission.

      The study design is an observational prospective active-surveillance hospital-based study,
      with a test-negative case-control design (TNCC) of hospitalized COVID-19 like cases
      undergoing testing for SARS-CoV-2
    

Detailed description: 
      LatInamerican Vaccine Effectiveness against hospitalizations due to circulating COVID-19 VoC
      RWE study is an observational prospective active-surveillance hospital-based study, with a
      test-negative case-control design (TNCC) of hospitalized COVID-19 like cases undergoing
      testing for SARS-CoV-2 by RT-PCR or rapid antigen test with the participation of countries
      from six LatAm Marketing Companies (Argentina, Brazil, Colombia, Costa Rica, Mexico and
      Panama).

      This study will generate new information regarding vaccine effectiveness (VE) in the RW
      setting for populations where evidence is still unavailable
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects older than 18y that are hospitalized due COVID-19 like symptoms
      
Biospecimen description: 
      For those participating on the control group (previous positive PCR/antigen test) a new
      COVID-19 PCR test will be performed to evaluate the type of variant
Efficacy and Safety Study of Abnoba Viscum F 20mg in Malignant Pleural Effusion Patients
Condition: Malignant Pleural Effusion
MeSH terms: Pleural Effusion, Malignant; Pleural Effusion
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase 3, non-randomized, Multicenter, single arm study to assess efficacy and safety of
      Abnoba viscum F 20mg in patients with malignant pleural effusion
    


Intervention name(s): Abnoba Viscum F 20mg
Intervention type(s): Drug
Intervention description(s): intravesical instillation of five amples of AbnobaViscum® F20mg and 0.9% normal saline into the pleural space
Other intervention name(s): viscum album extract; mistletoe extract; abnobaVISCUM
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment