bioihbjkbjnl/mcl2 huggingface dataset:
Effects Of Global Postural Re-Education (GPR) On Patients With Non-Specific Neck Pain.
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Pain is an "unpleasant sensory and emotional experience (associated with actual or potential
      tissue damage". Chronic pain is a sensation of hyperalgia to muscles, ligaments and skin on
      both active and passive movements. Chronic pain has a tendency to prevent people from working
      and exercising
    

Detailed description: 
      Neck pain is a very common clinical condition which equals the economic, social cost and
      level of disability to that of low back pain.Mechanical neck pain that occurs without an
      identifiable underlying disease and anatomical abnormality is termed as "non-specific" neck
      pain (NS-NP).Mechanical neck pain commonly arises insidiously and is generally multifactorial
      in origin.Two most common complains associated with chronic specific and non-specific neck
      pain are Kinesiophobia (fear of movement) and Postural asymmetry (forward head posture).
      Medical, surgical and physical therapy treatments are recommended for addressing chronic
      non-specific neck pain. Within the scope of physical therapy conventional management consist
      of many different techniques such as therapeutic exercises, electrotherapy, Pilates, yoga and
      manual therapy. Manual therapy is among the most common used method for treating
      musculoskeletal conditions including chronic neck pain. Manual therapy consists of stretching
      techniques, joint mobilization/manipulation, isometric/dynamic strengthening exercises and
      fascial manipulation or release. Global Postural Re-education (GPR) is an alternative
      therapeutic strategy based on the concept that postural muscles are organized in the form of
      'muscle chains' located on the anterior and posterior aspect of the spine. It involves the
      global stretching of the anti-gravitational muscles and the kinetic muscle chains.
    

Intervention name(s): Global Positional Re-education; Conventional Physical Therapy Program
Intervention type(s): Other; Other
Intervention description(s): A series of gentle active movements and postures aimed at realigning joints and stretching shortened muscles. GPR includes 8 therapeutic postures in lying, sitting and standing.; Axial traction will be given for 5 minutes, followed by mobilization of the muscle fascia along with static stretching of the scalene, levator scapulae, upper trapezius, sternocleidomastoid and pectoralis minor muscles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; Range of motion; Kinesiophobia; Forward head posture
An Efficacy and Safety Study of Telaprevir in Patients With Genotype 1 Hepatitis C Infection After Liver Transplantation
Condition: Chronic Hepatitis C Virus (HCV) Infection
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness of telaprevir in combination with
      Peg-IFN-alfa-2a and ribavirin in stable liver transplant patients with chronic hepatitis C
      virus (HCV) genotype 1.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), multicenter study
      in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks
      with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin
      followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total
      treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will
      include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital
      signs, and physical examination.
    

Intervention name(s): Telaprevir; Pegylated interferon alfa-2a; Ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Type=exact number, unit=mg, number=375, form=tablet, route=oral. Patients will receive 2 oral tablets (750 mg) every 8 hours for 12 weeks.; Type=exact number, unit=µg, number=180, form=injection, route=subcutaneous. 180 microgram (µg) per week, subcutaneous injection, for 48 weeks.; Type=exact number, unit=mg, number=200, form=tablet, route=oral. Starting from 600 mg (3 tablets) per day on Day 1. This dose will become higher or lower based on blood results and the investigators opinion (to a goal of 1000 to 1200 mg/day [5 to 6 tablets] based on subject weight), twice daily regimen, for 48 weeks.
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic HCV infection; Genotype 1 chronic HCV; Liver transplantation; Hepatitis C; Hep C; HCV; Telaprevir; Pegylated-Interferon-alfa-2a; Ribavirin
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Multiple Subcutaneous Doses of OLP-1002
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1b, randomised, double-blind, placebo-controlled, parallel study to evaluate
      the safety, tolerability, pharmacokinetics and preliminary efficacy of multiple SC doses of
      OLP-1002 in patients who have pain due to moderate to severe osteoarthritis (OA) in a hip
      and/or knee joint. The study consists of:

        -  Screening period: up to 14 days (defined as Day -23 to -9)

        -  Washout period: 5 days (± 1 day) (defined as Day -8 to -4)

        -  Baseline period: 3 days (± 1 day) (defined as Day -3 to -1, where Day -1 is the day
           before dosing)

        -  Treatment period: 15 days (± 1 day) (defined as Day 1 to 15, where Day 1 is the day of
           first dosing)

        -  Follow-up period: 30 days (± 5 days) (defined as Day 16 to 45, assuming Day 15 is the
           day of the last dose)

      Up to 30 patients will be enrolled in the study and will be randomised in the ratio 1:1:1 to
      the following arms:

        -  Arm A: 10 patients will receive 5 µg twice-weekly (BIW) OLP-1002

        -  Arm B: 10 patients will receive 10 µg BIW OLP-1002

        -  Arm C: 10 patients will receive Placebo BIW
    

Detailed description: 
      Study drug: OLP-1002

      Proposed Dose:

        1. 5 microgram twice a week (BIW) for 15 days (Day 1, 4, 8, 11 and 15)

        2. 10 microgram BIW for 15 days (Day 1, 4, 8, 11 and 15)

      Mode of Administration: Subcutaneous injection

      The study will consist of 5 time periods:

        -  Screening period: up to14 days

        -  Washout period: 5 days (± 1 day)

        -  Baseline period: 3 days (± 1 day)

        -  Treatment period: 15 days (± 1 day)

        -  Follow-up period: 30 days from last dose (± 5 days)

      Up to 30 patients will be enrolled in the study and will be randomised in the ratio 1:1:1 to
      the following arms:

        -  Arm A: 10 patients will receive 5 µg BIW OLP-1002

        -  Arm B: 10 patients will receive 10 µg BIW OLP-1002

        -  Arm C: 10 patients will receive Placebo BIW
    

Intervention name(s): A: OLP-1002; B: OLP-1002; C: Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 patients will receive 5 µg OLP-1002 twice-weekly (BIW) OLP-1002; 10 patients will receive 10 µg OLP-1002 BIW OLP-1002; 10 patients will receive Placebo BIW
Other intervention name(s): OLP-1002: A; OLP-1002: B; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Genomic Tools for Studying the Ecology of the Human Vaginal Microflora
Condition: Healthy
Study type: Observational

Summary: 
      The human vagina contains a large number of normal bacteria. These bacteria are important
      because provide protection against other bacteria that may cause disease. Several important
      diseases are linked to abnormal bacteria in the vagina. Women with abnormal bacteria in the
      vagina are more likely to be infected with human immunodeficiency virus, the virus that
      causes AIDS. Also women with unusual bacteria in their vagina are more likely to deliver a
      premature baby when they are pregnant. For these reasons, it is important to have a better
      understanding of the normal bacteria of the vagina.Some bacteria found in the vagina can not
      be grown in a laboratory. Our preliminary studies indicate a very wide variety of bacteria in
      the vagina. Also we have shown there are some differences between African American and
      Caucasian women. The goal of our study is to study the bacteria in the vagina of normal women
      using the latest technology. This technology involves study the bacterial DNA present in the
      normal microbes in the vagina
    

Detailed description: 
      The normal vaginal bacteria in healthy women of reproductive age plays a key role in
      preventing successful colonization by "undesirable" organisms including those responsible for
      bacterial vaginosis, yeast infections, sexually transmitted diseases and urinary tract
      infections. Our long-term goal is to develop an accurate understanding of the vagina
      microbial ecosystem in normal, healthy women as an essential prerequisite for comprehending
      how the normal microflora reduces the risk of acquiring these common vaginal infections.

      Four hundred women will be recruited such that there will be equal distribution among four
      self-declared ethnic groups (Caucasian, African-American, Hispanic and Asian). These
      groupings were selected based on the original Forney study that identified different
      distributions supergroups of dominant vaginal microflora between African-American and
      Caucasian women.

      The experimental focus of this proposal is to use a combination of culture-independent
      methods (T-RFLP of 16S rRNA, 16SrRNA and recA genes sequence analysis and community genomics)
      to develop tools aimed at advancing our understanding of the composition and role of
      individual organisms and communities that make up the ecosystems of human vaginas . The
      specific aims are designed to develop genomic tools for the research and clinical scientific
      community to study the ecology of the human vaginal microflora
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Asian, African American, Hispanic, or Cauasian women between the ages of 12 to 45 years old
      
Biospecimen description: 
      vaginal secretions
    
Keywords: vaginal; bacteria; microflora; bacterial DNA; To determine the normal bacteria in the vagina
The Combination of ATRA and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia
Condition: Immune Thrombocytopenia
MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomized, open-label, multicenter study to compare the efficacy and safety of ATRA plus
      high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line
      treatment of adults with primary immune thrombocytopenia (ITP).
    

Detailed description: 
      The investigators are undertaking a parallel group, multicenter, randomized controlled trial
      of 132 adults with ITP in China. Patients were randomized to ATRA+ high-dose dexamethasone
      and high-dose dexamethasone monotherapy group. Platelet count, bleeding and other symptoms
      were evaluated before and after treatment. Adverse events are also recorded throughout the
      study.
    

Intervention name(s): Dexamethasone; ATRA
Intervention type(s): Drug; Drug
Intervention description(s): Dexamethasone, iv, 40 mg/d, for 4 days (The 4-day course of dexamethasone was repeated in the case of lack of response by day 10); ATRA, po,10mg bid, for 12 weeks
Other intervention name(s): HD-DXM; High-dose Dexamethasone; All-trans retinoic acid
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Tretinoin; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Safety and Pharmacokinetics of Inhaled Ciprofloxacin in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      Objectives of the study are to investigate the safety, tolerability and levels of
      ciprofloxacin in the lung after single and multiple inhalative administration to patients
      with moderate to severe COPD (stage II-III according to GOLD Criteria)
    


Intervention name(s): Ciprofloxacin (PulmoSphere, BAYQ3939); Ciprofloxacin (PulmoSphere, BAYQ3939); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin PulmoSphere inhalation powder will be given as an initial single-dose inhalation (day 0).During the multiple-dose phase (day 2 to day 11), the same dose will be given twice daily, with a concluding single dose (on day 12); 48,75 mg ciprofloxacin betaine corresponding to 75 mg Ciprofloxacin PulmoSphere inhalation powder will be given as an initial single-dose inhalation (day 0).During the multiple-dose phase (day 2 to day 11), the same dose will be given twice daily, with a concluding single dose (on day 12); Placebo inhalation powder will be given as an initial single-dose inhalation (day 0).During the multiple-dose phase (day 2 to day 11), placebo will be given twice daily, with a concluding single dose (on day 12)
Intervention MeSH terms: Ciprofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Ciprofloxacin; Inhalation; Pharmacokinetics; Safety; Tolerability; COPD
A Study in Healthy Adults Investigating Eptinezumab Produced by 2 Different Manufacturing Cell Lines
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      Eptinezumab is a preventive treatment for migraine. The drug is made from a process that
      currently uses yeast cells for production of the drug. The trial researchers want to test
      whether using a new production cell line to make eptinezumab will affect the way the drug
      behaves in the body. To do this, the researchers will give a single dose of eptinezumab to
      healthy participants. Some of the participants will get eptinezumab that has been made from
      yeast cells. Others will get eptinezumab made with the new cell line.
    


Intervention name(s): Eptinezumab Mammalian Cell Line; Eptinezumab Yeast Cell Line
Intervention type(s): Drug; Drug
Intervention description(s): Concentrate for solution for IV infusion; Concentrate for solution for IV infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Rehabilitation in Patients With Progressive Supranuclear Palsy
Condition: Progressive Supranuclear Palsy
MeSH terms: Supranuclear Palsy, Progressive
Study type: Interventional

Summary: 
      The investigators evaluate whether an aerobic, intensive, goal based and multidisciplinary
      rehabilitation treatment, previously conceived for Parkinson's disease, is effective for
      patients with progressive supranuclear palsy and whether a driven gait orthosis (Lokomat) can
      provide further benefits.
    


Intervention name(s): MIRT; MIRT+Lokomat
Intervention type(s): Other; Other
Intervention description(s): It consists of a 4-weeks physical therapy which entails four daily sessions for five days. All treatments are performed in aerobic condition. The duration of each session, including recovery periods, is about one hour. The first session consists of a one-to-one session with physical therapist. The second session includes aerobic and repetitive exercises to improve balance and gait using different devices: a posturographic platform with visual cues, cycloergometer, treadmill-plus. The third is a session of occupational therapy. The last session includes one hour of speech therapy.
All patients undergo 20-minutes treadmill-plus training per day, 5 times a week, for 4 weeks.; It consists of a 4-weeks physical therapy which entails four daily sessions for five days. All treatments are performed in aerobic condition. The duration of each session, including recovery periods, is about one hour. The first session consists of a one-to-one session with physical therapist. The second session includes aerobic and repetitive exercises to improve balance and gait using different devices: a posturographic platform with visual cues and cycloergometer. The third is a session of occupational therapy to improve autonomy in activities of daily life. The last session includes one hour of speech therapy. All patients undergo 20-minutes Lokomat® training per day in spite of treadmill-plus.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rehabilitation; Robot-assisted walking training; Treadmill; Lokomat
Effects of Antioxidants on Human Macular Pigments
Condition: Eye Health
Study type: Interventional

Summary: 
      Age-related macular degeneration (AMD) is the leading cause of blindness in the United
      States. Low dietary intake or low blood levels of lutein and zeaxanthin, which are the only
      pigments found in the macular region of the human retina, has been associated with an
      increased risk for AMD. We have reported that the dietary supplementation of lutein and
      zeaxanthin can increase the macular pigments (MP) of the eye. MP effectively absorbs blue
      light as well as quenches reactive oxygen species (ROS). Green tea polyphenols are also
      effective scavenger of ROS in vitro.

      Our goal is to elucidate how to effectively increase MP by physiologic levels of antioxidant
      supplementation. We hypothesize that lutein and tea polyphenols protect the macula of the eye
      by increasing MP carotenoids effectively through an antioxidant mechanism.
    


Intervention name(s): Lutein; Lutein plus green tea extract
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Lutein (12 mg/d); lutein (12 mg/d) plus green tea extract (200 mg/d)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Macular pigment, lutein, green tea extract, antioxidant
A Study to Evaluate the Safety of K-755 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study designed to explore the safety, tolerability and pharmacokinetics of
      K-755 following oral administration to healthy male and female volunteers.
    


Intervention name(s): K-755 Part A (SAD); Placebo Part A (SAD); K-755 Part B (MAD); Placebo Part B (MAD); K-755 Part C (FE); K-755 Part D (FE); K-755 Part E (MAD); Placebo Part E (MAD)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single ascending dose (SAD). There will be 7 cohorts in the Part A. Three quarters of subjects will receive K-755 tablet orally in a double-blind fashion.; Single ascending dose (SAD). In Part A, one quarter of subjects will receive placebo tablet orally in a double-blind fashion.; Multiple ascending dose (MAD). There will be 4 cohorts in the Part B. Three quarters of subjects will receive K-755 oral tablet in a double-blind fashion.; Multiple ascending dose (MAD). In Part B, one quarter of subjects will receive placebo tablet orally in a double-blind fashion.; Food effect (FE). All subjects in Part C will receive K-755 oral tablet both under fed and fasted condition in a open-label, crossover fashion.; Food effect (FE). All subjects in Part D will receive K-755 oral tablet both under fed and fasted condition in a open-label, crossover fashion.; Multiple ascending dose (MAD). There will be 2 cohorts in the Part E. Three quarters of subjects will receive K-755 oral tablet in a double-blind fashion.; Multiple ascending dose (MAD). In the Part E. One quarter of subjects will receive placebo tablet orally in a double-blind fashion.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Sequential Assignment/Crossover (for food effect)
Masking: Double (Participant, Investigator)
Primary purpose: Other
AMX0035 in Patients With Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Nervous System Diseases; Central Nervous System Diseases
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Diseases; Central Nervous System Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The CENTAUR trial was a 2:1 (active:placebo) randomized, double-blind, placebo-controlled
      Phase II trial to evaluate the safety and efficacy of AMX0035 for the treatment of ALS.
    

Detailed description: 
      AMX0035 is a combination therapy designed to reduce neuronal death through blockade of key
      cellular death pathways originating in the mitochondria and endoplasmic reticulum (ER). This
      clinical trial is designed to demonstrate that treatment is safe, tolerable, and able to slow
      decline in function as measured by the ALSFRS-R. The trial will also assess the effects of
      AMX0035 on muscle strength, vital capacity, and biomarkers of ALS including markers of
      neuronal death and neuroinflammation.
    

Intervention name(s): AMX0035; Placebo
Intervention type(s): Drug; Other
Intervention description(s): AMX0035; Matching Placebo Comparator
Other intervention name(s): Proprietary formulation of taurursodiol and sodium phenylbutyrate
Intervention MeSH terms: 4-phenylbutyric acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized; Double-blind; Placebo-controlled; Amyotrophic Lateral Sclerosis; Sodium Phenylbutyrate; Tauroursodeoxycholic Acid