bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Safety Study of Alogliptin Used in Combination With Sulfonylurea or Metformin in Participants With Type 2 Diabetes in Japan
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To evaluate the efficacy and safety of alogliptin administered as an add-on to sulfonylurea
      (glimepiride) or metformin, once daily (QD), twice daily (BID) or three times daily (TID).
    

Detailed description: 
      Both insulin hyposecretion and insulin-resistance are considered to be involved in the
      development of type 2 diabetes mellitus.

      Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients
      with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV
      (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2
      peptide hormones released in response to nutrient ingestion. It is expected that inhibition
      of DPP-IV will improve glycemic control in patients with type 2 diabetes.

      This was a phase 2/3, multicenter, open-label study, in participants who had completed the
      core phase 2/3 sulfonylurea add-on study (SYR-322/CCT-005; NCT01318083) or the core phase 2/3
      metformin add-on study (SYR-322/CCT-006; NCT01318109) to evaluate the safety and efficacy of
      alogliptin administered as an add-on to a sulfonylurea (glimepiride) or metformin
      continuously for 40 weeks (52 weeks from the start of study treatment with alogliptin in the
      core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
    

Intervention name(s): Alogliptin and glimepiride; Alogliptin and glimepiride; Alogliptin and metformin; Alogliptin and metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.; Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.; Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.; Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Other intervention name(s): SYR-322; Amaryl; SYR-322; Amaryl; SYR-322; Glycoran; SYR-322; Glycoran
Intervention MeSH terms: Metformin; Glimepiride; Alogliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus - Type 2; Diabetes Mellitus; Drug Therapy
The Oakland Men's Health Disparities Study
Condition: Behavior; Cardiovascular Risk Factor; Influenza
Study type: Interventional

Summary: 
      Reducing racial disparities in health outcomes is a major policy concern in the United
      States. Although there has been recent progress to close the gap, black men continue to
      experience earlier morbidity and mortality from preventable and manageable medical
      conditions, and live on average 4.2 years less than their white male peers. An oft-prescribed
      solution to close this stubborn gap is to increase the diversity of the healthcare workforce.
      Another common policy tool to increase take-up of preventative healthcare services is
      financial incentives. In this randomized evaluation, we will estimate the effects of
      financial incentives and a racially concordant physician on the uptake of preventive health
      services in Oakland, California.
    


Intervention name(s): Concordant
Intervention type(s): Behavioral
Intervention description(s): We will be randomizing across providers - we are particularly interested in racial concordance.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years
Condition: Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients
MeSH terms: Infections; Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study investigated the efficacy of inhaled TOBI treatment for early infections of P.
      aeruginosa in paediatric patients with cystic fibrosis.
    


Intervention name(s): TOBI; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TOBI (tobramycin inhaled solution); Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tobramycin Inhalation solution; Cystic fibrosis; Lung disease; anti-bacterial agents
Randomized Trial of In-Home Cervical Cancer Screening in Underscreened Women
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      The purpose of this trial is to determine whether mailing in-home human papillomavirus (HPV)
      screening kits is effective in increasing uptake of cervical cancer screening and early
      detection and treatment of cervical neoplasia in underscreened women.
    

Detailed description: 
      Over half of all cervical cancers in the U.S. are diagnosed in unscreened or underscreened
      women. New national guidelines identify increasing screening uptake as the number one
      priority for reducing cervical cancer-related morbidity and mortality. Innovative screening
      strategies that eliminate the need for clinic-based screening could be highly effective in
      improving screening compliance while maintaining high-quality care. We propose a large,
      pragmatic randomized controlled trial within Group Health (a large integrated health care
      delivery system in Washington State) to compare effectiveness of two programmatic approaches
      to increasing cervical cancer screening among overdue women. The first approach (control arm)
      is usual care at Group Health, which consists of patient- and provider-level services to
      promote adherence to Pap screening, and the second approach (intervention arm) includes usual
      care plus a mailed in-home high-risk human papillomavirus (hrHPV) screening kit. We will
      randomize eligible women to the in-home hrHPV screening arm or the usual care arm. Compared
      to usual care, we hypothesize that in-home hrHPV screening will enhance early detection and
      treatment of cervical neoplasia and improve compliance with screening. The trial will provide
      definitive evidence-based data on the impact of an in-home hrHPV screening program in a
      real-world clinical setting.
    

Intervention name(s): Mailed in-home high-risk HPV testing kit; Usual care
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligibility is assessed weekly over 2.5 years. Study participants are assigned to the control arm or to the intervention arm. After follow-up is complete, control arm participants are re-assessed for eligibility and re-randomization.
Masking: Single (Investigator)
Primary purpose: Screening
Keywords: cervical cancer; screening; human papillomavirus; cervical intraepithelial neoplasia
Cognitive Therapy in Patients Failing ART
Condition: HIV; Cognitive Therapy
Study type: Interventional

Summary: 
      Highly active antiretroviral therapy (HAART) has been the greatest achievement to control the
      HIV/AIDS epidemic in the world. HAART has been shown to reduce virus replication to
      undetectable levels and to favor the recovery of immune function, avoiding the occurrence of
      opportunistic diseases. Although existing treatments have been shown to lower AIDS-related
      morbimortality and to increase patients' quality of life, the success of HAART requires high
      levels of adherence to the prescribed treatment regimen.

      Adherence to HAART has become the major challenge for global public policy managers and
      healthcare teams involved in the care of HIV/AIDS patients. Mental healthcare professionals
      should use structured and effective intervention as strategies to facilitate a better
      approach, increase patients' autonomy and achieve optimal adherence.

      Trial-Based Cognitive Therapy (TBCT) is a new, structured, and short-term version of
      cognitive behavior therapy developed by de Oliveira (2011). TBCT is an active approach that
      aims to change negative cognitions, especially dysfunctional core beliefs, that negatively
      influence patient's life in different domains. TBCT helps patients recognize situationally
      based thoughts, unhelpful beliefs and maladaptive behaviors that exacerbate emotional
      distress.

      This study aims to assess the efficacy of TBCT in helping the patients to identify thoughts,
      emotions, assumptions and behaviors associated with non-adherence to antiretroviral therapy,
      and to improve adherence to treatment.
    


Intervention name(s): Trial-Based Cognitive Therapy; Control group. Standard healthcare.
Intervention type(s): Behavioral; Other
Intervention description(s): Participants in the TBCT intervention arm will have 14 (fourteen) psychotherapy sessions over a period of 7 (seven) months. The frequency of the intervention is biweekly with a duration of approximately 90 minutes per session. We will have10 groups with 5 participants each. All participants will practice the learned techniques during the meetings, have a manual with a description summary of the sessions and the activities to practice at home. The main TBCT techniques that will be used are case conceptualization, intrapersonal thought record, consensual role-play, action plan, trial-based thought record and trial-based metacognitive awareness.; Participants with therapeutic failure, receiving the standard healthcare in the HIV / AIDS Program, which includes at least a half-yearly psychology and pharmaceutical chemist consultations (approximately half an hour each).
The purpose of these consultations is to approach the importance of adherence and psychoeducation on HIV
Other intervention name(s): TBCT; Standard healthcare
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: HIV; Cognitive therapy; Treatment; HAART; Treatment adherence and compliance
Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema
Condition: Hereditary Angioedema; Hereditary Angioedema Type I; Hereditary Angioedema Type II; Hereditary Angioedema Types I and II; Hereditary Angioedema Attack; Hereditary Angioedema With C1 Esterase Inhibitor Deficiency; Hereditary Angioedema - Type 1; Hereditary Angioedema - Type 2; C1 Esterase Inhibitor Deficiency; C1 Inhibitor Deficiency
MeSH terms: Angioedema; Angioedemas, Hereditary; Hereditary Angioedema Types I and II
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the efficacy of orally administered deucrictibant for the acute
      treatment of attacks in patients with hereditary angioedema (HAE). Eligible subjects are
      randomized to one of three single doses of deucrictibant and placebo. The study will compare
      symptom relief (skin pain, skin swelling, abdominal pain) during HAE attacks and safety of
      each dose of deucrictibant with placebo.
    

Detailed description: 
      In Part I of the study, patients in non-attack state receive the assigned active single dose
      of deucrictibant at the study center to assess pharmacokinetics (the way the body absorbs,
      distributes, and gets rid of the drug) and safety. In Part II of the study, patients
      self-administer blinded study drug at home to treat three HAE attacks with deucrictibant or
      placebo (cross-over).
    

Intervention name(s): Deucrictibant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): deucrictibant soft capsules for oral use; Matching placebo capsules for oral use
Other intervention name(s): PHA-022121; PHA121; PHVS416
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HAE; HAE Type I; HAE Type II; Oral Treatment; Bradykinin B2 Receptor Antagonists; PHVS416; PHA121; PHA-022121; Deucrictibant
A Study to Assess the Reversal of the Anticoagulant Effects of Milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) (Part 1) and Recombinant Human Factor VIIa (rFVIIa) (Part 2) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the reversal of the anticoagulant effects of
      milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) and Recombinant Human Factor
      VIIa (rFVIIa) in healthy participants as measured by changes from baselines of the
      coagulation testing parameters (activated partial thromboplastin time [aPTT] and thrombin
      generation assay [TGA]).
    


Intervention name(s): Milvexian; 4-Factor Prothrombin Complex Concentrate (4F-PCC); Recombinant Human Factor VIIa (rFVIIa); Placebo matching to 4F-PCC; Placebo matching to rFVIIa
Intervention type(s): Drug; Biological; Biological; Biological; Biological
Intervention description(s): Milvexian will be administered orally.; 4F-PCC will be administered intravenously.; rFVIIa will be administered intravenously.; Placebo matching to 4F-PCC will be administered intravenously.; Placebo matching to rFVIIa will be administered intravenously.
Other intervention name(s): BMS-986177; JNJ-70033093
Intervention MeSH terms: Thrombin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intravenous/Subcutaneous FIH Study of REGN1154 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to study the safety and tolerability of intravenous (IV) and
      subcutaneous (SC) administration of REGN1154 in normal healthy subjects.
    


Intervention name(s): REGN1154 or placebo
Intervention type(s): Drug
Intervention description(s): Participants will receive active drug or placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Effects of Transcranial Direct Current Stimulation on Pain Perception
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a new medical technology can temporarily
      alter pain perception. The new technology is called Transcranial direct current stimulation
      (tDCS).
    

Detailed description: 
      Healthy subjects underwent thermal pain tolerance testing pre- and post intervention. The
      intervention includes either anodal, cathodal, or sham tDCS for 20 minutes during a pain
      cognitive intervention [either brief cognitive intervention (BCI) or general pain education].
      The tDCS brand was the Phoresor-II Auto (Model PM850, Iomed, Salt Lake City Utah, USA) and
      the current was set to 2.0mA. Electrodes were 4x4 cm sponge electrodes soaked in sterile
      saline. For anodal and cathodal tDCS, One electrode was placed over the left DLPFC (F3 from
      the EEG 10-20 system) located via the Beam F3 measurement system and the other electrode was
      attached to the right shoulder. For sham tDCS, the device was turned on for 30 seconds to
      temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for
      the duration of the 20-minute session.
    

Intervention name(s): anodal tDCS; cathodal tDCS; sham tDCS
Intervention type(s): Device; Device; Device
Intervention description(s): a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder; a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode attached to the right shoulder and the cathode electrode placed over the left DLPFC.; Participants were provided pain education during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session
Other intervention name(s): Transcranial Direct Current Stimulation; Phoresor-II Auto; Transcranial Direct Current Stimulation; Phoresor-II Auto; Transcranial Direct Current Stimulation; Phoresor-II Auto
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Healthy Adults; Pain Perception
Study Of Weight Development Over Time
Condition: Obesity; Insulin Resistance; Weight Reduction; Weight Gain
MeSH terms: Insulin Resistance; Body Weight; Weight Gain; Weight Loss
Study type: Observational

Summary: 
      The investigators will study the influence of fat cell size/number and adipose function on
      weight development over very long time periods (years). By comparing fat biopsies obtained at
      baseline and after >7 years, the investigators will determine the association between adipose
      morphology/function and changes in weight or development of cardiometabolic complications
      (e.g. insulin resistance, type 2 diabetes, dyslipidemia and hypertension).
    

Detailed description: 
      The investigators will ask all subjects that have previously been examined at the
      investigators laboratory (from 1992 and forward) in studies of adipose tissue function if
      they are interested to participate in a new study. The minimal follow up time is 7 years.

      Saved blood samples and samples from old fat biopsies will be analyzed together with samples
      from new examinations.

      The investigators plan to examine the subjects in the same way as performed at the baseline
      examinations. This includes estimation of total body fat using bioimpedance, venous blood
      samples for determination of insulin, glucose and lipids, subcutaneous fat biopsies with
      determination of fat cell size/number, lipolysis/lipogenesis as well as analysis of adipokine
      secretion.

      In selected patients, baseline examinations included DEXA-measurement (dual energy x-ray
      absorptiometry) for determination of body fat distribution as well as hyperinsulinemic
      euglycemic clamp. In these cases, the same type of examinations will be repeated at their
      follow up visits.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Observational study All subjects that have been previously investigated at our lab at least
        7 years ago
      
Biospecimen description: 
      Whole blood, serum, plasma, adipose tissue, adipocytes
Examining Outcome Expectancies and Behavioral Reinforcers Among Young Adult Smokers
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      Chronic cigarette smoking habits often begin in adolescence or early adulthood. 98% of
      cigarette smokers try their first cigarette before the age of 26. Thus, young adult smokers
      represent an important target for early smoking cessation intervention. This study tests two
      interventions designed to increase motivation to quit and decrease smoking behavior. These
      interventions include: an expectancy challenge approach, which aims to increase negative
      beliefs about the consequences of smoking; and a behavioral economics approach, which
      encourages participants to substitute non-smoking behaviors that may still provide
      reinforcement similar to reinforcement derived from smoking a cigarette.
    


Intervention name(s): Expectancy Challenge; Expectancy Challenge + Behavioral Activation; Control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Expectancy challenge intervention (see description in study arms).; Expectancy challenge + behavioral activation interventions (see description in study arms); Neutral reading condition (see description in study arms).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: smoking cessation; motivation; outcome expectancies; behavioral reinforcers
Study About Safety and Efficacy of Coenzyme Q10 in Progressive Supranuclear Palsy
Condition: Progressive Supranuclear Palsy
MeSH terms: Paralysis; Supranuclear Palsy, Progressive
Study type: Interventional
Phase: Phase 2

Summary: 
      Study hypothesis:

      A 6-week p.o treatment with 5 mg/Kg Coenzyme Q10 is safe and tolerable,increases the brain's
      metabolism and ameliorates clinical symptoms in patients with PSP.
    

Detailed description: 
      Background and Rationale:

      1. Progressive Supranuclear Palsy (PSP, Steele-Richardson-Olszewski Syndrome) is a sporadic
      neurodegenerative disorder resulting clinically in a Parkinson syndrome (i.e. akinetic-rigid
      movement disorder) with prominent postural instability, oculomotor deficits, and cognitive
      decline (for review: Albers and Augood, 2001; Burn and Lees, 2002). With an average annual
      incidence of 5.3 per 100000 and an age-adjusted prevalence of 6.4 per 100000, PSP is as
      common as motor-neuron disease (Burn and Lees, 2002). There is no symptomatic treatment,
      because PSP patients do not respond to any known therapy (Albers and Augood, 2001; Burn and
      Lees, 2002). The progression of PSP is rapid and the median survival after onset of symptoms
      is 5-10 years (Albers and Augood, 2001). Presently, there is no known effective symptomatic
      or neuroprotective therapy for PSP.

      2. Evidence suggests an impairment of mitochondrial energy metabolism in PSP (Albers and
      Beal, 2002):

        1. Reduced cerebral glucose and ATP metabolism have been shown in functional imaging
           studies in PSP patients (Forster et al., 1988; Martinelli et al., 2000).

        2. Cybrid cells harboring mitochondrial genes from PSP patients have decreased ATP-levels
           and complex I activity (Swerdlow et al., 2000; Albers et al., 2001; Chirichigno et al.,
           2002).

        3. A tropical PSP-like tauopathy has been linked clinically and experimentally to the
           consumption of the fruit and teas of leaves of the tropical plant annona muricata rich
           in lipophilic complex I inhibitors (Caparros-Lefebvre et al., 1999; 2001). These
           clinical observations suggest a role for mitochondrial dysfunction in the etiology of
           PSP.

      3.Coenzyme Q10 (CoQ10) is the physiological electron recipient of complex I. Exogenous CoQ10
      (1.) enhances the electron transport by complex I and (2.) powerfully scavenges free
      radicals. Thus, CoQ10 has been shown to reduce the toxicity of complex I inhibitors in vitro
      (Menke et al., 2003) and in vivo (Beal et al., 1998
    

Intervention name(s): Coenzyme Q10
Intervention type(s): Drug
Intervention MeSH terms: Ubiquinone; Coenzyme Q10
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Progressive Supranuclear Palsy; Coenzyme Q10