bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Algorithm for Post-Stroke Gait Training With C-Brace
Condition: Hemiparesis Due to Stroke; Hemiplegia Due to Stroke
MeSH terms: Stroke; Hemiplegia; Paresis
Study type: Interventional

Summary: 
      The purpose of this study is to develop a clinical algorithmic-based evaluation and treatment
      approach for C-Brace for use by persons with hemiparesis or hemiplegia due to stroke.
    


Intervention name(s): C-Brace
Intervention type(s): Device
Intervention description(s): C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Interaction Between High Dose Sulfamethoxazole/Trimethoprim and Zidovudine
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      To determine if the pharmacokinetics of high doses of zidovudine (AZT) (that is, how fast AZT
      reaches the blood, what concentration of AZT is attained in the blood, and how long AZT
      remains in the blood) changes from day to day in the same patient. Also to determine whether
      the pharmacokinetics of AZT is changed when trimethoprim/sulfamethoxazole (SMX/TMP) is given
      at the same time, or whether the pharmacokinetics of SMX/TMP is altered by AZT given at the
      same time.

      AZT has been effective in treating HIV infection in some patients with AIDS, and SMX/TMP is
      an antibiotic combination which is useful in preventing or treating Pneumocystis carinii
      pneumonia (PCP). It is important to know how drugs interact in patients because addition of a
      second drug may change the speed at which a drug is eliminated from the body, and cause
      increased toxic effects or decreased therapeutic effects.
    

Detailed description: 
      AZT has been effective in treating HIV infection in some patients with AIDS, and SMX/TMP is
      an antibiotic combination which is useful in preventing or treating Pneumocystis carinii
      pneumonia (PCP). It is important to know how drugs interact in patients because addition of a
      second drug may change the speed at which a drug is eliminated from the body, and cause
      increased toxic effects or decreased therapeutic effects.

      Patients with HIV infection take AZT every 4 hours and/or SMX/TMP every 8 hours by mouth for
      4 days as outpatients and then come into the clinical research center for 2 days of studies.
      On day 5 the final dose of medicine is given orally SMX/TMP or by intravenous infusion (AZT).
      Blood samples are drawn 10-20 times over a period of 12 hours and urine is collected for 36
      hours. Concentrations of the drugs in the blood and urine samples are determined. This
      sequence is repeated twice, so that each patient takes AZT alone, SMX/TMP alone, and the
      combination of AZT and SMX/TMP over a period of about 3 weeks. Patients may be included in
      the study if they are asymptomatic, or have been diagnosed with ARC or AIDS, but not if they
      have PCP or any other severe opportunistic infection.
    

Intervention name(s): Sulfamethoxazole-Trimethoprim; Zidovudine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Zidovudine; Trimethoprim; Sulfamethoxazole; Trimethoprim, Sulfamethoxazole Drug Combination
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Trimethoprim-Sulfamethoxazole Combination; AIDS-Related Opportunistic Infections; Pneumonia, Pneumocystis carinii; Drug Interactions; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine; Sulfamethoxazole-Trimethoprim
Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature
Condition: Primary Vascular Dysregulation
Study type: Interventional

Summary: 
      It is already known that the local treatment with Alphagan eye drops (a drug commonly used by
      glaucoma patients) reduces ocular blood flow. In-vitro studies suggest that the
      vasoconstrictive effect of Alphagan is more pronounced when this drug is combined with a
      prostaglandin analogue (eg. Xalatan eye drops). The investigators also question whether this
      effect is more pronounced in subjects suffering from a primary vascular dysregulation (PVD).
      To test for the effect of these drugs on PVD and non-PVD subjects the investigators will take
      measurements of corneal temperature as surrogate for ocular blood flow.
    

Detailed description: 
      The investigators would like to investigate the effect of Alphagan eye drops, Xalatan eye
      drops and their combination (both Alphagan and Xalatan) on corneal temperature in healthy
      subjects with and without a primary vascular dysregulation (PVD).

      The investigators would like to answer the following questions:

        1. Do the individual drugs influence the circulation to the eye as quantified indirectly
           via corneal temperature?

        2. Does the combination of Alphagan and Xalatan give an additive or even potentiated
           effect?

        3. Is the sequence of application of drugs of relevance (Alphagan applied first, Xalatan
           second, or vice versa)?

        4. Do PVD and non-PVD subjects respond differently to these drugs?

      20 healthy non-PVD subjects and 20 healthy PVD subjects in the age range from 20-40 years
      will be recruited. Recruited subjects will have all measurements: corneal temperature,
      intraocular pressure (IOP), ear temperature, blood-pressure. Both prior to and after
      instillation of eye drops (Xalatan, Alphagan and placebo).
    

Intervention name(s): Brimonidine; Latanoprost; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Week1, day2: 1 eyedrop/right eye Week2, day1: 1 eyedrop/left eye Week2, day2: 1 eyedrop/left eye; Week1, day1: 1 eyedrop/right eye Week1, day2: 1 eyedrop/right eye Week2, day2: 1 eyedrop/left eye; Week1, day1: 1 eyedrop/left eye Week1, day2: 2 eyedrops/left eye Week2, day1: 1 eyedrop/right eye Week2, day2: 2 eyedrops/right eye
Other intervention name(s): Alphagan; Xalatan; Fermavisc
Intervention MeSH terms: Brimonidine Tartrate; Latanoprost
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Alphagan; Xalatan; corneal temperature; primary vascular dysregulation
Nutritious Eating With Soul (The NEW Soul Study)
Condition: Cardiovascular Disease Risk Factors; Overweight and Obesity
MeSH terms: Cardiovascular Diseases; Overweight
Study type: Interventional

Summary: 
      This study addresses two challenges seen among African American (AA) participants during
      previous weight loss and dietary interventions aimed at reducing cardiovascular disease (CVD)
      risk: poor weight loss results and high attrition rates. Investigators will target both of
      these challenges by using a randomized design to compare a plant-based dietary intervention
      (vegan diet) vs. an omnivorous (omni) diet and by focusing on culturally-tailored food
      choices for AA adults living in the South. Therefore, the objective of the study is to
      conduct a culturally-tailored, randomized trial examining how a vegan diet affects CVD risk
      factors and weight as compared with an omni diet. The study will randomize overweight AA
      adults (n=130) to follow one of two different diets (vegan or omni) for 24 months.
      Investigators will accomplish objectives and test hypotheses by following two specific
      primary aims:

      Primary Aims: Using a randomized design, determine the impact at 12 months of two different,
      culturally tailored diets (n=65 omni and n=65 vegan) on changes in:

        1. Risk factors for CVD, including LDL cholesterol and blood pressure; and

        2. Body weight.

           Secondary Aim

        3. Examine long-term changes in CVD risk factors and body weight at 24 months.
    


Intervention name(s): Dietary Intervention Meetings; Physical Activity; Podcasts/Mailings
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will attend classes once per week for the first 6 months, bi-weekly for the next 6 months; then once a month for the last 12 months.; Participants will be given the following exercise recommendations: strength training twice per week and ≥75 min of vigorous or ≥150 min of moderate PA per week and will be provided with accelerometers.; Participants with receive additional support delivered remotely months 13-24 in the form of audio podcasts and email newsletters.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
DDI Study Between Dorzagliatin and Rifampicin
Condition: Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this drug-drug interaction study is to investigate the impact of rifampicin on
      the pharmacokinetics of Dorzagliatin.
    


Intervention name(s): Dorzagliatin
Intervention type(s): Drug
Intervention description(s): GKA currently under clinical development
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase Ⅱ Study of an All-Oral Combination of Low-dose Etoposide/Capecitabine in Patients With Metastatic Breast Cancer Previously Treated With Anthracyclines and/or Taxanes
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-center, open-lable, non-comparative, prospective, phase Ⅱ efficacy and
      safety study. Eligible patients are enrolled in a single group. The investigators propose to
      determine the efficacy and safety of low-dose metronomic chemotherapy with
      Etoposide/Capecitabine in Patients with Metastatic Breast Cancer Previously Treated with
      Anthracyclines and/or Taxanes.
    


Intervention name(s): Capecitabine; Etoposide
Intervention type(s): Drug; Drug
Intervention description(s): Drug:capecitabine 700mg/m2, twice daily on days 1-14.; Etoposide 30mg/m2, once daily on days 1-7.
Intervention MeSH terms: Capecitabine; Etoposide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Infrared Thermography for Assessment of Caudal Block in Children
Condition: Anesthesia, Conduction
Study type: Interventional

Summary: 
      Regional analgesia via caudal neuraxial blockade provides pain relief for pediatric patients
      following urological and lower extremity procedures. The injection of local anesthetic into
      the caudal epidural space causes a sensory loss. This sympathetic blockade in turn causes a
      vasodilation, or increased blood flow, to the lower extremities.

      The purpose of this study is to determine whether the FLIR ONE thermographic camera, a
      smartphone attachment which utilizes an application ("app") to measure the temperature at a
      site on an image of the lower extremity, will be able to differentiate between caudal,
      non-caudal, and failed caudal images.
    


Intervention name(s): FLIR ONE; Regional Anesthesia - Caudal Nerve Block
Intervention type(s): Device; Procedure
Intervention description(s): Thermographic assessment of the lower extremities is obtained using the FLIR ONE smartphone camera and software.; Nerve block placement as a pain management strategy indicated for certain urological and lower extremity surgeries.
Intervention MeSH terms: Anesthetics
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Effects on Plasma Exchange on Functional Capacity of Serum Albumin, Circulatory Dysfunction, Renal and Cerebral Function in Cirrhotic Patients With "Acute-on-chronic Liver Failure"
Condition: Liver Cirrhosis; Liver Failure
MeSH terms: Liver Cirrhosis; Liver Failure; Hepatic Insufficiency; End Stage Liver Disease; Acute-On-Chronic Liver Failure; Fibrosis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects on plasma exchange with 5% albumin on
      albumin functional capacity, cardiocirculatory, renal and cerebral function in cirrhotic
      patients with "acute-on-chronic liver failure".
    

Detailed description: 
      The purpose of this study is to evaluate the effects on plasma exchange with 5% albumin on
      albumin functional capacity, cardiocirculatory, renal and cerebral function in cirrhotic
      patients with "acute-on-chronic liver failure", renal disfunction, cerebral disfunction ,and
      inflamtory response
    

Intervention name(s): Plasma exchange with albumin
Intervention type(s): Procedure
Intervention description(s): Realization of 6 plasma exchange with albumin in 11 days
Other intervention name(s): Albumina grifols 5%
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cirrhosis; cirrhotic patients with acute on chronic liver failure
The Organ Protection of Astragalus in Subjects With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Metabolic syndrome have the damages on tissues and organs in heart、kindey and vessels. In
      this study, prospective randomized, controlled, parallel designed ,different doses of
      Astragalus Mongolia, Gansu Longxi produce treat on the MS patients, and then use real-time
      quantitative PCR and Western Blotting to detect the index of oxidative stress
      、angiotensin-converting enzyme 2 mRNA expression and proteins.
    


Intervention name(s): low dose Astragalus; high dose astagalus
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: 5-10 gram astragalus per day
Influence of Diet and Lifestyle Factors on the Results of the IVF
Condition: Lifestyle Factors
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is study the possible relationship between various lifestyle habits
      of men and women (age, body mass index, diet, exercise, alcohol, tobacco, coffee, etc..) and
      live birth rate after in vitro fertilization-intracytoplasmatic injection (IVF-ICSI).
    

Detailed description: 
      It is a prospective study of couples with primary or secondary infertility, with indication
      for IVF. The main objective is to relate different lifestyle factors (age, BMI, physical
      activity, tobacco consumption, alchol, drugs, work and diet) with reproductive outcomes
      obtained in terms of total oocytes, M II, fertilization and implantation rates pregnancy and
      abortion rates and live birth. It also attempts to correlate the different habits of life in
      men with seminal parameters. For this, both members of the pair separately should answer a
      validated questionnaire before beginning the therapeutic process.
    

Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): Questionnaire with 100 questions divided into different groups: general data, work, physical activity, character, hobbies, disease and diet.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study sample is obtained from the population of infertile couples who meet the criteria
        for inclusion in a protocol for controlled ovarian stimulation for IVF/ICSI.
An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild and Moderate Hepatic Insufficiency and Healthy Volunteers
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the
      effect of impaired hepatic function on the PK of deferiprone and its 3-O-glucuronide
      metabolite following a single oral dose of 33mg/kg Ferriprox®.
    

Detailed description: 
      Post-marketing study to evaluate the effect of impaired hepatic function on the
      pharmacokinetics (PK) of deferiprone and its 3-O-glucuronide metabolite and on the safety of
      Ferriprox® in subjects with mild and moderate hepatic impairment as compared to healthy
      volunteers.
    

Intervention name(s): Ferriprox®
Intervention type(s): Drug
Other intervention name(s): DFP; Deferiprone; L1
Intervention MeSH terms: Deferiprone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Hepatic Impairment; Liver Impairment; Liver Disease; Ferriprox®; LI; DFP; Deferiprone
Treatment of Sequelae Caused by Severe Brain Injury With Autologous Adipose-derived Mesenchymal Stem Cells
Condition: The Sequelae Caused by Severe Brain Injury
MeSH terms: Brain Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study is to investigate the efficacy and safety of autologous transplantation of
      adipose-derived mesenchymal stem cells in patients with the sequelae caused by severe brain
      injury.
    


Intervention name(s): autologous adipose-derived mesenchymal stem cells
Intervention type(s): Biological
Intervention description(s): Patients will receive five infusions, one month apart, each comprising 5-7x10^7 cells of autologous adipose-derived mesenchymal stem cells.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Observance of Long Term Oxygen Therapy in Chronic Inspiratory Disease Patients
Condition: Chronic Respiratory Disease; Hypoxemia
MeSH terms: Respiratory Tract Diseases; Respiration Disorders; Hypoxia
Study type: Observational

Summary: 
      Long-term oxygen therapy (LTOT) is the reference treatment for chronic respiratory failure.
      This treatment is based on the principle of oxygen supplementation via a source to correct
      hypoxemia in patients. At present, adherence to this treatment is difficult to evaluate
      (reporting by patients), but the results of the literature show poor LTOT compliance. It is
      therefore important to accurately measure the oxygen consumption by patients and to
      understand the factors explaining LTOT compliance. The ultimate aim is to improve our patient
      management to make them more observant in order to improve the therapeutic efficacy of the
      treatment.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients are recruited from pneumologia unit of hospital and from private pneumologists
A Clinical Investigation to Assess the Performance of Natural Rubber Latex Condoms in Couples
Condition: Control of Pregnancy; Prevention of Sexually Transmitted Infections
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This investigation is designed to evaluate the performance rate of a new natural rubber latex
      (NRL) male condom.
    

Detailed description: 
      In this clinical investigation, a new NRL male condom (test condom) will be evaluated against
      two marketed NRL male condoms of varying thickness (condom A and condom B). This clinical
      investigation will also evaluate the in-use tolerance of the test and the two reference
      condoms.
    

Intervention name(s): NRL Condom
Intervention type(s): Device
Intervention description(s): A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to Subjects to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 3 condom types.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The condom types will be tested in a three-way cross-over design where couples will be randomised to use each of the three condom types in a defined order, according to the randomisation schedule.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Magnetically Navigated vs. Manually Guided Radiofrequency in Atrioventricular-node-reentry-tachycardia
Condition: Atrioventricular Nodal Reentry Tachycardia; Radiofrequency Ablation
MeSH terms: Tachycardia; Tachycardia, Atrioventricular Nodal Reentry
Study type: Interventional
Phase: Phase 4

Summary: 
      The MAGMA-AVNRT study compares two different methods of handling the ablation catheters for
      av-node-reentry-tachycardia with regard to x-ray dose, safety and success: manually guided vs
      magnetically navigated RF-catheter.
    

Detailed description: 
      AV-node reentry tachycardia can be treated by radiofrequency ablation or modulation of the
      slow pathway of the av node. The success rate is 90 to 95%.

      There are different options to navigate the ablation catheter: manually guided vs
      magnetically guided.

      For magnetic guidance two magnets are positioned beneath the patient. A mangetic field is
      induced and a catheter with a ferromagnetic tip can be navigated from outside with a joystick
      by modifying the vectors of the magnetic field.

      We hypothesized that a magnetic guidance of the RF-ablation catheter results in lower x-ray
      time and dose for the patient and the physician with comparable safety und success rates.
    

Intervention name(s): RF-ablation
Intervention type(s): Procedure
Intervention description(s): 4mm-tip catheter manually guided vs magneticallly navigated
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AV-node reentry tachycardia; radiofrequency ablation; magnetic navigation system
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-1944 in Healthy Adults
Condition: Prevention of Chikungunya Virus Infection
MeSH terms: Chikungunya Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, FIH, single-center, randomized, placebo controlled, dose escalation study
      to evaluate the safety, tolerability, PK, and PD of mRNA-1944 in healthy adult subjects.
      Cohorts of mRNA-1944 are planned to be investigated in a sequential dose escalation manner.
    


Intervention name(s): mRNA-1944; Placebo
Intervention type(s): Biological; Other
Intervention description(s): mRNA encoding Chikungunya antibody; Saline
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Chikungunya fever; Alphavirus infections; Togavirus; Viral diseases