bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluated the Effectiveness of Milnacipran to Reduce Pain Levels in Individuals With Chronic Migraine
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine if milnacipran taken twice daily is effective in
      reduction of headache pain.
    

Detailed description: 
      Milnacipran is a serotonin norepinephrine reubtake inhibitor (SNRI) approved for the
      management of fibromyalgia in the United States.

      Migraine and fibromyalgia have significant co-morbidity. Of 100 patients with fibromyalgia,
      76% had chronic headaches, of whom 63% had migraine. Interestingly, general measures of pain,
      disability, sleep quality, and psychological distress were similar in individuals with
      fibromyalgia with and without headache. Conversely, the prevalence of fibromyalgia in women
      with migraine was reported as 22%, and at a headache referral center, 36% of headache
      patients had fibromyalgia.

      Because of significant co-morbidity, as well as the likelihood of shared pathophysiologic
      mechanisms, there is reason to believe that a medication effective for fibromyalgia might
      reduce migraine pain, especially where the pain has taken on the nature of a chronic pain
      disorder, as in chronic migraine. The current study evaluated the benefits of milnacipran in
      individuals with chronic migraine.

      Patients with chronic migraine were randomized to either Milnacipran or Placebo. Patients
      completed 30 days of baseline followed by 90 days of headache diaries while taking assigned
      medication. Primary outcomes were reduction in pain severity and improvement in migraine
      specific quality of life (MSQ) while secondary outcomes included reduction in migraine and
      non-migraine headache days and symptomatic use of medication for migraine. Independent sample
      t-tests were used to evaluate the changes in primary and secondary measures between the two
      groups.
    

Intervention name(s): Milnacipran; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): titration schedule starting with 12.5mg per day increasing to 50mg twice a day, starting with day 1 to day 90 and then taper down as appropriate for dose.; Placebo dosing schedule was Day 1-2, 1 tablet daily, Day 3-6 BID, Day 7-14 BID, Day 15 an on through day 90 BID and taper down
Other intervention name(s): Savella; Sugar Pill
Intervention MeSH terms: Milnacipran; Levomilnacipran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: headache; migraine
Long-term Fasting: Multi-system Adaptations in Humans
Condition: Fasting
Study type: Interventional

Summary: 
      The aim of this trial is to investigate the effects of long-term fasting on size, mass,
      composition and function of metabolic active tissues in several organs that reexpand possibly
      rejuvenated after 1-4 months. Additionally, the lipid metabolism is investigated in depth.
    

Detailed description: 
      Fasting displays numerous positive effects on metabolism, health and aging. Surprisingly, few
      considerations are given to long-term fasting periods.

      The metabolic switch from food-derived glucose to adipose tissue-derived fatty acids and
      ketones as primary cellular fuel is the key to fasting metabolism. Fasting has been shown to
      improve cardiovascular risk factors and gut microbiota in humans. It provokes profound
      changes in lipid metabolism. However, many questions are still open concerning the
      mobilization, exchange, and function of lipids during long-term fasting. Furthermore, recent
      results show the ability of periodic restrictive nutritional strategies to trigger organ
      regeneration. This promising regenerative power has not been investigated comprehensively in
      humans. In addition, the knowledge about the role of human faecal microbiota in health and
      disease is increasing. Only little is known about its composition and function during
      fasting. We found indications that the gut microbiome could influence energy metabolism and
      consequently could influence the dynamic of the metabolic switch.

      Long-term fasting under medical supervision according to the Buchinger Wilhelmi fasting
      program has been demonstrated to be safe and well-tolerated.

      The current project investigates the effects of a 9±3 days fasting period by a multi-systemic
      approach focusing on lipid metabolism and the gut microbiome in 100 subjects. Additionally,
      the body composition in combination with muscle performance will be analyzed in-depth in a
      subgroup of 32 subjects.
    

Intervention name(s): Long-term fasting according to the Buchinger Wilhelmi fasting program
Intervention type(s): Other
Intervention description(s): the participants will undergo a fasting program that includes the daily intake of 250 kcal under medical supervision
Intervention model: Single Group Assignment
Intervention model description: single-arm interventional study
Masking: None (Open Label)
Primary purpose: Other
Keywords: long-term fasting; Buchinger Wilhelmi program; magnetic resonance imaging (MRI); magnetic resonance spectroscopy (MRS); HDL efflux capacity; fatty acid profile in erythrocyte membrane; gut microbiota; metabolomics; hydrogen sulfide and transsulfuration pathway
The Impact of Genotype on Pharmacokinetics and Antiplatelet Effects of Ticagrelor in Healthy Chinese
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a open and single center clinical trial in healthy Chinese.The objective of the
      study is to clarify the pharmacokinetics characteristics and antiplatelet effects of
      ticagrelor in Chinese and to investigate the impact of genotype.
    

Detailed description: 
      This is an open-label, single-does, nonrandomized study of ticagrelor in healthy volunteers
      carried out at a single center. Written informed consent will be obtained from all volunteers
      before initiation of the study. The study is approved by the Research Ethic Committee of
      Guangdong General Hospital. Fifty-one healthy Chinese will be recruited.

      Venous blood will be collected at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48h after taking
      180mg ticagrelor orally. Urine collection intervals are at predose and 0 to 2, 2 to 4, 4 to
      6, 6 to 9, 9 to 12, 12 to 16 and 16 to 24h after dosing. The concentration of ticagrelor and
      its metabolites will be analyzed using a separately validated liquid chromatography technique
      with tandem mass spectrometric detection (LC-MS/MS).

      Besides，the basic principle of population pharmacodynamics(PPD) is applied to evaluate
      antiplatelet effects. Adenosine diphosphate(ADP)-stimulated platelet aggregation will be
      assessed at baseline, and 0.5h/1h, 2h, 4h/8h/24h, 48h/3d/5d and 7d after dosing.

      The effects of genetic variants on antiplatelet and pharmacokinetic response to ticagrelor
      are investigated through a genome-wide association study (GWAS).
    

Intervention name(s): Ticagrelor
Intervention type(s): Drug
Intervention description(s): 180 mg loading dose
Other intervention name(s): Brilinta; AstraZeneca
Intervention MeSH terms: Ticagrelor
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetics; antiplatelet effects; single nucleotide polymorphism (SNP)
Fear Conditioning Using Computer-Generated Virtual Reality
Condition: Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Observational

Summary: 
      The purpose of this study is to use a computer-generated virtual reality environment to study
      fear conditioning. Fear conditioning is used to explore the causes and persistence of anxiety
      and anxiety disorders.

      When confronted with fearful or unpleasant events, people can develop fear of specific cues
      that were associated with these events as well as to the environmental context in which the
      events occurred via a process called classical or aversive conditioning. Advances in
      computer-generated visual stimulations could facilitate the design of new aversive
      conditioning studies. This study will develop a virtual reality environment to examine human
      contextual fear conditioning in the laboratory. During the procedure, moderately painful
      stimuli will be administered. Participants in this study will be screened with a medical
      history, physical examination, psychiatric evaluation, and hearing test. Participants will
      wear headphones and special goggles that will enable them to view a virtual reality
      environment. Measures will be taken during the study to see how the brain adapts to
      environmental stimuli.
    

Detailed description: 
      Fear conditioning paradigms are tools to explore symptoms of anxiety disorders. During fear
      conditioning, the organism develops fear to the phasic explicit cue (e.g., a light) that was
      associated with the aversive unconditioned stimulus (e.g., a shock) during conditioning as
      well as to the environmental context (e.g., the experimental room). Explicit cue conditioning
      and context conditioning are separate processes mediated by distinct brain structures.
      Whereas explicit cue conditioning is only dependent on the amygdala, context conditioning
      involves the amygdala, the hippocampus and the bed nucleus of the stria terminalis (BNST). We
      have been using explicit cue and context conditioning as models of phasic fear and sustained
      anxiety, respectively. However, contextual fear is relatively difficult to study in humans in
      the laboratory because it requires two experimental sessions and the use of different
      experimental rooms. Advances in computer-generated visual stimulation now offer the
      possibility to develop more sophisticated paradigms in the laboratory that could facilitate
      the design of fear conditioning studies. In addition, compared to traditional paradigms,
      computer generated three-dimensional stimulation provides the opportunity to create more
      realistic virtual environment. The main objective of this study is to use virtual reality to
      further our understanding of fear conditioning in humans.
    

Keywords: Stress; Anxiety; Adults; Fear Conditioning; Normal Volunteers; Associative Learning; Virtual Reality; Context Conditioning; Healthy Volunteer; HV; Normal Control
A Comparison of Paclitaxel-based Three Regimens Concurrent With Radiotherapy for Patients With Local Advanced Esophageal Cancer
Condition: Stage III Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determined the best scheme in paclitaxel and
      cisplatin，paclitaxel and fluorouracil，paclitaxel and carboplatin concurrent with radiotherapy
      for patients with local advanced esophageal Squamous Cell Carcinoma.
    


Intervention name(s): Paclitaxel and Cisplatin; Paclitaxel and Fluorouracil; Paclitaxel and Carboplatin; Radiotherapy
Intervention type(s): Drug; Drug; Drug; Radiation
Intervention description(s): patients get Paclitaxel and Cisplatin according to protocol; patients get Paclitaxel and Fluorouracil according to protocol; patients get Paclitaxel and Carboplatin according to protocol; 1.8Gy/d, d1-5/week, 34Fx
Other intervention name(s): TP; TF; TC
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin; Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: esophageal squamous cell carcinoma; concurrent chemoradiotherapy; paclitaxel; cisplatin; carboplatin; fluorouracil
VELCADEXA: Velcade and Dexamethasone in Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary efficacy objective of this study is to study the efficacy in terms of response
      rate to alternating bortezomib/dexamethasone regimen
    

Detailed description: 
      Multiple Myeloma is a plasma cell disorder characterized by an uncontrolled proliferation of
      bone marrow plasma cells leading to skeletal destruction with bone pain, anemia, renal
      failure, hypercalcemia, recurrent bacterial infections and extramedullary plasmacytomas. It
      accounts for 1% of all malignancies and slightly more than 10% of hematologic malignancies,
      with an annual incidence of about four per 100.000. Although this disease is incurable with a
      median survival of about 3 years, remarkable treatment advances have been recently made,
      including high-dose therapy followed by stem cell rescue and, particularly, the introduction
      of novel promising agents with new mechanisms of action.

      Data from pre-clinical and clinical studies conducted to date support the continued
      development of VELCADE for the treatment of Multiple Myeloma. Standard chemotherapy remains
      as the gold standard for induction before HDT/SCT treatment in younger multiple myeloma
      patients (<65 years). Since VELCADE has a mechanism of action different from chemotherapy and
      dexamethasone and is considered to be efficacious in Multiple Myeloma, its introduction in
      induction regimens may contribute to increase the response rate and eventually survival of
      these patients that represent half of myeloma population.

      Since VBMCP/VBAD is considered to be the gold standard for Multiple Myeloma patients <65
      years as induction regimen prior HDT/SCT, the results of VEL/DEX will be compared with those
      obtained in 100 patients treated with VBMCP/VBAD chemotherapy in our last GEM protocol
      (Spanish Myeloma Group) for patients <65 years (closed in Dec 2004
    

Intervention name(s): Velcade/Dexamethasone
Intervention type(s): Drug
Intervention description(s): Velcade 1,3 mg/m2 on days 1, 4, 8 and 11
Intervention MeSH terms: Dexamethasone; Bortezomib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Múltiple Myeloma; Transplant; Patients <65 years.
Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor
Condition: Tolerability; Pharmacokinetics; Endostatin
Study type: Interventional
Phase: Phase 1

Summary: 
      1. MTD and DLT of M2ES

        2. Pharmacokinetics of M2ES
    

Detailed description: 
      Patients received infusion of M2ES for 120 minutes weekly（d1,d8,d15）by calculated pump and
      underwent evaluation of vital signs including blood pressure, pulse, respiratory rate, and
      temperature before treatment, at intervals during infusion, and hourly for 6 hours after
      infusion. After infusion, patients underwent serial pharmacokinetic sampling. All patients
      were seen weekly during the study therapy and follow-up and underwent evaluation with
      physical examination including ECOG performance status, vital signs, and laboratory
      evaluation with complete blood count with manual differential, chemistry evaluation,
      prothrombin time/partial thromboplastin time, and urinalysis.
    

Intervention name(s): PEDylated Recombinant Human Endostatin
Intervention type(s): Drug
Intervention description(s): The initial dose of PEDylated Recombinant Human Endostatin (M2ES) will be 7.5mg/m2.Dose Escalation to a next higher level will occur when 3 patients in the same dose level complete 28 days of continuous treatment without experiencing a dose-limiting toxicity.
Other intervention name(s): M2ES
Intervention MeSH terms: Endostatins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tolerability; Pharmacokinetics; Endostatin; antiangiogenesis; cancer
HIT on Hypoglycemic Risk in Type 1 Diabetes (T1D)
Condition: Type1diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      There is clear evidence that regular exercise improves wellbeing and reduces the risk of
      diabetes related complications in people with type 1 diabetes. However, many people with type
      1 diabetes do not exercise regularly. The primary reason for this is fear of hypoglycaemia
      and loss of glycaemic control associated with exercise. This loss of glycaemic control is
      associated with traditional moderate intensity continous aerobic exercise advocated in the
      guidelines for exercise in people with type 1 diabetes. Recent work (unpublished) from our
      lab suggests high intensity interval training (HIT) may reduce the risk of hypoglycaemia in
      people with type 1 diabetes, however stronger evidence is needed before firm conclusions can
      be drawn.

      Therefore, the aim of this study is to determine the effects of HIT on glycaemic control in
      people with type 1 diabetes compared to no exercise and traditional moderate intensity
      continous exercise.

      24 people with type 1 diabetes will be recruited to complete a randomised counterbalanced
      cross over study comparing 3x 2-week interventions periods. During these intervention periods
      participant will maintain their habitual lifestyle but complete either no exercise (control),
      traditional moderate intensity continous exercise or high intensity interval training.
      Throughout the intervention periods participants glycaemic control will be monitored using a
      flash glucose monitor.
    


Intervention name(s): high intensity interval training; moderate intensity continous training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will complete 6 sessions of high intensity interval training during a 2 week intervention period. The programme involves repeated 1 minute bouts of simple on the spot movements interspersed with 1 minute of rest.; Participants will complete 6 sessions of moderate intensity continous training during a 2 week intervention period. Participants will be asked to complete 30 minutes of continuous exercise.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Discharge Education of Integrated Traditional and Western Medicine Reduces Re-hospitalization in Patients With Chronic Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Although interventions combining patient education and postdischarge management have
      demonstrated benefits in patients with chronic heart failure, the benefit attributable to
      patient education alone is not known. The investigators hypothesized that a patient discharge
      education program would improve clinical outcomes in patients with chronic heart failure.
    

Detailed description: 
      Although interventions combining patient education and postdischarge management have
      demonstrated benefits in patients with chronic heart failure, the benefit attributable to
      patient education of Integrated Traditional and Western Medicine is not known. The
      investigators hypothesized that a patient discharge education of Integrated Traditional and
      Western Medicine program would improve clinical outcomes in patients with chronic heart
      failure.
    

Intervention name(s): Discharge Education of Chinese Medicine
Intervention type(s): Behavioral
Intervention description(s): Discharge Education of Integrated Traditional and Western Medicine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Patient Education; Chinese Medicine
Bioequivalence of Two Formulations of Esomeprazole
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      Bioequivalence of Two Formulations of Esomeprazole 40mg
    

Detailed description: 
      A randomized, two-way crossover, single-dose pharmacokinetic study to evaluate the
      bioequivalence of a test formulation of Esomelone powder for solution for injection/infusion
      40mg (Esomeprazole 40mg), compared to an equivalent dose of a reference drug product (Nexium
      powder for injection and infusion 40mg) in healthy adult subjects.
    

Intervention name(s): Esomelone; Nexium
Intervention type(s): Drug; Drug
Intervention description(s): powder for injection/ infusion Esomeprazole 40mg; powder for injection/ infusion Esomeprazole 40mg
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment Of Patients With Social Anxiety Disorder
Condition: Social Phobia
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 2

Summary: 
      GW876008 is a drug which may change mans reaction to stress, by decreasing the fear, physical
      and behavior symptoms that people with SocAD experience in social situations.
    


Intervention name(s): GW876008; paroxetine
Intervention type(s): Drug; Drug
Other intervention name(s): GW876008
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: safety; outpatients with a diagnosis of Social Anxiety disorder (SocAD).; effectiveness
Dose-finding of PB-119 Administered Subcutaneously Once-weekly Versus Placebo in Drug-naïve T2DM Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort,
      multiple dose study to evaluate the efficacy, safety, and tolerability of different doses of
      PB-119 in drug-naïve subjects with T2DM.
    

Detailed description: 
      Subjects will be assessed for eligibility over a 2-week screening period prior to a 2-week
      run-in period and a 12-week double-blind treatment period,4-week follow up period. The
      eligible patients will be randomized to 1 of 3 dose cohorts (A, B, or C). Each patient will
      subsequently be randomized within the designated cohort to active drug or placebo at a 3:1
      active drug:placebo ratio.
    

Intervention name(s): PB-119 75ug; PB-119 150ug; PB-119 200ug; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 60 eligible patients will be included in this group; 60 eligible patients will be included in this group; 60 eligible patients will be included in this group; 60 eligible patients will be included in this group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment