bioihbjkbjnl/mcl2 huggingface dataset:
The Investigation Of Exercise Capacity And Exercise-Induced Fatigue in Young Adults Who Survived From Coronavirus
Condition: Covid19
MeSH terms: Coronavirus Infections
Study type: Observational [Patient Registry]

Summary: 
      The effects of Coronavirus Disease (COVID-19), a multisystem disease, on the body system and
      functions are being investigated all over the world. Examining the effect of exercise
      capacity, which is an important marker of cardiovascular risk in young individuals with
      COVID-19, will allow the planning of exercise and physical activity programs according to the
      needs of that specific population. The objectives of this project are:(1) To compare the
      submaximal and maximal exercise capacity of young adults aged between 18-30 who have had
      COVID-19 with healthy individuals in the same age group (2) To determine the roles of muscle
      strength, respiratory functions, fatigue, dyspnea, and physical activity level on exercise
      capacity evaluated by two different tests in young adults survived from COVID-19.
    

Detailed description: 
      The effects of COVID-19, a multisystem disease, on the body system and functions are being
      investigated worldwide. For young adults, exercise capacity is vital in the workforce,
      cardiovascular risk factors and long-term health perception. Determining exercise capacity,
      which is an essential indicator of cardiovascular risk in the long term, and determining the
      factors affecting exercise capacity in cases with COVID-19 will allow the planning of
      exercise and physical activity programs according to young people's needs. The objectives of
      this project are:(1) To compare the submaximal and maximal exercise capacity of young adults
      aged between 18-30 who have had COVID-19 with healthy individuals in the same age group (2)
      To determine the roles of muscle strength, respiratory functions, fatigue, dyspnea, and
      physical activity level on exercise capacity evaluated by two different tests in young adults
      survived from COVID-19. There is no study in the literature evaluating the exercise capacity
      and the factors affecting the prolonged COVID-19 symptoms for patients with COVID-19. This
      project can provide objective evidence on this subject and includes controlled
      multi-directional measurement.
    

Intervention name(s): 6-minute walk test; Incremental shuttle walk test
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): This test assesses submaximal exercise capacity.; This test assesses maximal exercise capacity.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The subjects who survived from COVID-19 aged between 18-30 and healthy individuals in the
        same age will be included in the project.
      
Keywords: coronavirus; exercise capacity
Safety and Efficacy Study of Fx-1006A in Patients With Familial Amyloidosis
Condition: Familial Amyloid Polyneuropathy
MeSH terms: Polyneuropathies; Amyloid Neuropathies; Amyloid Neuropathies, Familial; Amyloidosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will examine whether Fx-1006A is effective in halting the progression of Familial
      Amyloid Polyneuropathy (FAP).

      Deposition of TTR amyloid is associated with a variety of human diseases. Deposition of
      amyloid fibrils of variant TTR (primarily V30M) in peripheral nerve tissue produces the
      condition called FAP.

      The prevention of the formation of amyloid by stabilization of the TTR native state should
      constitute an effective therapy for amyloid diseases. Therapeutic intervention with a TTR
      stabilizer drug, such as Fx-1006A, is hypothesized to stop progression of the disease in FAP
      patients. FAP is a uniformly fatal disease and Fx-1006A is intended to halt the relentless
      neurological deterioration FAP patients experience.

      This Phase 2/3 study will enroll early to mid-stage FAP patients in order to interrupt and
      stabilize the disease at a point in time where progression of motor and autonomic dysfunction
      can be maximally effected. Male and female patients with FAP with documented V30M TTR
      mutation will receive Fx-1006A or placebo once daily for a period of eighteen (18) months.
    

Detailed description: 
      Deposition of TTR amyloid is associated with a variety of human diseases. Deposition of
      amyloid fibrils of variant TTR (primarily V30M) in peripheral nerve tissue produces the
      condition called FAP.

      The prevention of the formation of amyloid by stabilization of the TTR native state should
      constitute an effective therapy for amyloid diseases. Therapeutic intervention with a TTR
      stabilizer drug, such as Fx-1006A, is hypothesized to stop progression of the disease in FAP
      patients. FAP is a uniformly fatal disease and Fx-1006A is intended to halt the relentless
      neurological deterioration FAP patients experience.

      This Phase 2/3 study will enroll early to mid-stage FAP patients in order to interrupt and
      stabilize the disease at a point in time where progression of motor and autonomic dysfunction
      can be maximally effected. Male and female patients with FAP with documented V30M TTR
      mutation will receive Fx-1006A or placebo once daily for a period of eighteen (18) months.
    

Intervention name(s): Fx-1006A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Fx-1006A 20mg or matched placebo once daily (at the same time each day) for a period of 18 Months; Fx-1006A 20mg or matched placebo once daily (at the same time each day) for a period of 18 Months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: FAP; Fx-1006A; transthyretin; TTR; amyloid; polyneuropathy; V30M; familial; hereditary; amyloidosis; FoldRx
Single Ascending Dose Study Using DS-1971 to Assess Safety, Tolerability, and Pharmacokinetics in Healthy Participants.
Condition: Safety; Tolerability; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomised, double-blind, placebo-controlled and ascending single dose study. It is
      hypothesised that single oral doses of DS-1971a within the planned dose range will be safe
      and well tolerated by healthy male subjects.
    


Intervention name(s): DS-1971; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 6 subjects in each group will receive DS-1971.; 2 subjects in each group will receive placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Transcranial Direct Current Stimulation for Dysphagia Therapy in Acute Stroke Patients
Condition: Stroke; Dysphagia
MeSH terms: Deglutition Disorders; Stroke
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate whether transcranial direct current stimulation of
      the cerebral swallow motor cortex in addition to standard care can enhance recovery of
      swallow function in acute dysphagic stroke patients compared to sham treatment plus standard
      care.
    


Intervention name(s): Transcranial direct current stimulation; Sham stimulation
Intervention type(s): Device; Device
Intervention description(s): 20 Minutes of transcranial direct current stimulation (20 min, 1 mA) administered over the contralesional cortical swallow motor area once daily over 4 consecutive days. In case of a brainstem stroke stimulation will be applied over the cortical swallow motor area of the right hemisphere.; 20 Minutes of sham transcranial direct current stimulation (20 min, no current applied) administered over the contralesional cortical swallow motor area once daily over 4 consecutive days. In case of a brainstem stroke sham stimulation will be applied over the cortical swallow motor area of the right hemisphere.
Other intervention name(s): tDCS; sham tDCS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transcranial direct current stimulation; stroke-related dysphagia; cortical plasticity
A Safety Tolerance and Experimental Hyperalgesia Study of Oral NGX426 in Healthy Male Voluneteers
Condition: Healthy; Hyperalgesia
MeSH terms: Hyperalgesia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effects of NGX426 on intradermal capsaicin
      induced pain in hyperalgesia.
    


Intervention name(s): Placebo; Oral NGX426 (Powder in solution)
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Impact of TENS on Postoperative Pain and Quality of Life After Inguinal Hernia Repair
Condition: Inguinal Hernia; Postoperative Pain; Quality of Life; Transcutaneous Electric Nerve Stimulation
MeSH terms: Pain, Postoperative; Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      Lichtenstein herniorrhaphy still remains one of the most often performed inguinal hernia
      repair techniques. It is frequently associated with acute postoperative and chronic pain. Due
      to insufficient effect of non-steroidal anti-inflammatory drugs, they are often overdosed.
      However opioids have many side effects. Interventional treatment, such as transversus
      abdominis plain (TAP) block requires an additional intervention and has relatively short
      effect, also could not be applied in outpatient conditions. The hypoalgesic effect of
      transcutaneous electric nerve stimulation (TENS) is well known for many years, but
      effectiveness during postoperative period is still controversial and maybe therefore didn't
      come to daily practice. However it could be a promising part of multi-modal pain treatment
      for hernia patients. This study analyse the hypoalgesic effect of TENS and its impact on
      hernia specific quality of life (QoL) after Lichtenstein hernia repair.

      Aim#1 To determine whether use of TENS is effective for acute postoperative pain relief.

      Aim#2 To determine whether use of TENS have impact on hernia specific QoL in early and late
      postoperative period.

      Aim#3 To identify factors associated with effectiveness/ineffectiveness of TENS procedures.

      Aim#4 To determine whether a psychological condition (depression, anxiety and pain
      catastrophisation) is somehow associated with TENS effectiveness.
    


Intervention name(s): Transcutaneous electric nerve stimulation
Intervention type(s): Device
Intervention description(s): Conventional transcutaneous electric nerve stimulation
Other intervention name(s): TENS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Inguinal hernia; Transcutaneous electric nerve stimulation; Postoperative pain; Quality of life; Pain threshold; Algometry
Pharmacokinetics, Safety & Tolerability of Isotopologs of Atazanavir (ATV), With Pharmacokinetic Comparison to Reyataz
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacokinetics of
      isotopologs of Atazanavir both as single agents and as combinations.
    

Detailed description: 
      There are two parts to this study. Part A is a three-period, crossover design. Eligible
      subjects will be randomized to 1 of 4 sequences, in groups of 4 subjects each. All study drug
      doses, including the comparator, Reyataz, will be administered as single, open-labeled doses
      to subjects after a light meal. There will be a 7-day washout between individual subjects
      doses; that is, dosing will occur on the same day each week.

      Part B evaluations are based on the results of Part A. Part B will further consist of two
      subparts. In the first subpart, low single doses of 2 new isotopologs will be dosed to two
      groups of 4 subjects each, B1 and B2, respectively. Following assessment of safety and
      pharmacokinetics in the first subpart, the second subpart, which consists of three groups of
      8 subjects (B3, B4, B5) each will be dosed. Subjects enrolled in B3, B4, and B5 will
      participate in a 3-way partial crossover study design.

      The objectives will be to compare the PK properties, in healthy male subjects after a light
      meal, of single oral doses of single agent ATV isotopologs or as combinations of two ATV
      isotopologs with the PK properties in the same subjects, after a light meal, of a single dose
      of either 400 mg or 600 mg Reyataz. The safety and tolerability will also be evaluated.

      Blood samples for pharmacokinetic analysis will be collected. Actual dosing and sampling
      times will be used for analysis.
    

Intervention name(s): C-10276; C-10276; C-10297; C-10299; C-10297; C-10299; C-10276; Reyataz®
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): C-10276 200 mg, C-10276 400 mg, Reyataz 400 mg oral, single dose; C-10276 300 mg, CTP-518 100 mg with C-10276 300 mg, C-10276 400 mg oral, single dose; C-10297 200 mg, oral, single dose; C-10299 200 mg, oral, single dose; C-10297 400 mg, Reyataz 400 mg, C-10297 600 mg, oral, single dose; C-10299 400 mg, Reyataz 400 mg, C-10299 600 mg, oral, single dose; C-10276 600 mg, Reyataz 400 mg, Reyataz 600 mg, oral, single dose; Reyataz 400 mg, oral, single dose Reyataz 600 mg, oral, single dose
Intervention MeSH terms: Atazanavir Sulfate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fluid Resuscitation With HES 200/0.5 10% in Severe Burn Injury
Condition: Survival; Renal Failure
MeSH terms: Renal Insufficiency; Burns
Study type: Interventional
Phase: Phase 3

Summary: 
      HES 200/0.5 10% is equal to ringers lactat solution.
    

Detailed description: 
      30 Patients were enrolled to the study, either to the hyperoncotic HES 200/0.5 (10%) group or
      to the crystalloids only group. After a treatment protocol of 72 hours we collected data
      about complications like pulmonary failure and abdominal compartment syndrome. Furthermore,
      we addressed the question of incidence of mortality and renal failure.
    

Intervention name(s): fluid resuscitation; Fluid resuscitation
Intervention type(s): Drug; Drug
Intervention description(s): fluid resuscitation with HES; Fluid resuscitation in standardized fashion
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Doxycycline in Treatment of Bleeding With Depot Medroxyprogesterone Acetate (DMPA)
Condition: Uterine Hemorrhage
MeSH terms: Uterine Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to test the effect of Doxycycline in treatment of uterine bleeding during the
      use of injectable contraception that contains one hormone "progesterone only".
    


Intervention name(s): Doxycycline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg Doxycycline capsules twice daily for 5 days; Placebo capsules twice daily for 5 days
Intervention MeSH terms: Doxycycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Effect of Exercise on Neurorecovery Following Mild Traumatic Brain Injury
Condition: Brain Concussion
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Interventional

Summary: 
      The study is a "proof-of-principle" project to examine the safety and feasibility of
      implementing a 1-week aerobic exercise program in the post-acute phase after mild traumatic
      brain injury (mTBI). The study will define the extent to which the exercise program improves
      recovery from mTBI in terms of relevant functional outcomes (cognition, mood, and physical
      status) and biomarkers (peripheral brain-derived neurotrophic factor [BDNF] concentration).
    

Detailed description: 
      This is a "proof-of-principle" project for human subjects to examine the safety and
      feasibility of implementing a 1-week aerobic exercise program in the post-acute phase after
      mild traumatic brain injury (mTBI). This study will define the extent to which the exercise
      program improves recovery from mTBI in terms of relevant functional outcomes (cognition,
      mood, and physical status) and biomarkers (peripheral brain-derived neurotrophic factor
      [BDNF] concentration). This project will also lay the foundation for understanding the
      relationship between exercise and BDNF in the area of mTBI neurorecovery, thereby allowing
      future studies to develop best-practice methods for implementing exercise interventions as a
      treatment option for brain injuries.
    

Intervention name(s): Aerobic Exercise; Non-Aerobic Exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Aerobic exercise will consist of riding a stationary bicycle at moderate intensity for 2 consecutive, 20-minute periods with a 5-minute break in between. Moderate intensity is defined as maintaining 65-75% of estimated maximum heart rate based on the calculation (HRmax = 208 - 0.7 × age).; Non-Aerobic exercise will consist of very low-intensity movements including static stretching and toning exercises.Participants will complete 2 consecutive, 20-minute periods with a 5-minute break in between, mirroring the aerobic exercise condition. Heart rate will be monitored by research staff to ensure that it remains below 50% of estimated maximum heart rate.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Mild Traumatic Brain Injury; Aerobic Exercise; Brain-Derived Neurotrophic Factor
Pharmacodynamics, Preliminary Pharmacokinetics and Tolerability of BIBB 515 BS or Pravastatin in Hyperlipemic Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigation of pharmacodynamics (inhibition of oxidosqualene cyclase, MES as marker),
      effect on routine lipid profile parameters, safety and preliminary pharmacokinetics
    


Intervention name(s): BIBB 515 BS; Pravastatin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Pravastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Drug-interaction Trial in Healthy Subjects With Oral Administration of Empagliflozin (BI 10773), Rifampicin and Probenecid
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of the trial are to investigate the effect of concurrent administration of
      rifampicin and probenecid on the pharmacokinetics of empagliflozin.
    


Intervention name(s): Probenecid; Rifampicin; Empagliflozin; Empagliflozin; Rifampicin; Probenecid; Empagliflozin (BI 10773)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Probenecid; Rifampicin; BI Drug; BI Drug; Rifampicin; Probenecid; BI Drug
Intervention MeSH terms: Empagliflozin; Rifampin; Probenecid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Liraglutide as add-on to Metformin Compared to Either Liraglutide or Metformin Alone, or to a Combination of Metformin and a SU (Sulphonylurea) Agent in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effect
      on glycemic control of NNC 90-1170 (liraglutide) added to metformin compared to metformin
      given alone in subjects with type 2 diabetes previously treated with OHAs (oral hypoglycaemic
      agents).
    


Intervention name(s): liraglutide; metformin; placebo; placebo; glimepiride
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously; 1000 mg daily, administered orally; Metformin placebo administered orally. 1000 mg daily; NNC 90-1170 placebo. Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously; Individually adjusted dose, administered orally
Intervention MeSH terms: Metformin; Liraglutide; Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation
Condition: Atrial Fibrillation; Stroke
MeSH terms: Stroke; Atrial Fibrillation
Study type: Interventional

Summary: 
      The purpose of this study is to compare a minimally invasive surgical procedure and
      medication management in stroke patients with Atrial Fibrillation. The two treatment options
      are a minimally invasive surgical procedure or the use of medications.
    

Detailed description: 
      Must have had a stroke or transient ischemic attack (TIA) and have Atrial Fibrillation
    

Intervention name(s): Minimally Invasive Surgery; Medical therapy
Intervention type(s): Procedure; Other
Intervention description(s): Small thumb sized incisions are made on each side of the chest wall where instruments are inserted for the purpose of completing the surgery.; Patients are treated with rhythm and rate control medications.
Other intervention name(s): Minimally Invasive Maze Procedure; Medical Management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment