bioihbjkbjnl/mcl2 huggingface dataset:
A Multi-Center Study of Lapatinib in Patients With Trastuzumab-refractory Metastatic Breast Cancer
Condition: HER2 Positive Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluating the Efficacy of Lapatinib in Combination With Chemotherapy in Patients With
      Trastuzumab-refractory Metastatic HER2-positive Breast Cancer.
    

Detailed description: 
      Some studies has demonstrated that even in trastuzumab pretreated patients with HER-2
      positive breast cancer, might benefit from the treatment of trastuzumab. However, there is
      small benefit for some patients having short disease-free survival after adjuvant trastuzumab
      or short progression-free survival after first-line trastuzumab-based therapy. In clinical
      practice, the investigators also found it is fact. And the investigators have a scientific
      rationale for clinical testing of lapatinib plus chemotherapy in patients with
      trastuzumab-refractory, metastatic HER2-positive breast cancer.
    

Intervention name(s): lapatinib and capecitabine or vinorelbine
Intervention type(s): Drug
Intervention description(s): lapatinib 1250 mg qd and Capecitabine 1000 mg/m2 bid or Vinorelbine 25mg/m2(d1,d8)
Other intervention name(s): Tykerb; Xeloda;NVB
Intervention MeSH terms: Capecitabine; Vinorelbine; Lapatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Olanzapine Versus Aripiprazole in the Treatment of Acutely Ill Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purposes of this study are to assess similarities and differences in the efficacy (how
      well the drug works), safety, and side effects of olanzapine and aripiprazole in patients
      with schizophrenia, schizoaffective disorder, or schizophreniform disorder.
    


Intervention name(s): Olanzapine; Aripiprazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olanzapine; Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Dacomitinib (PF-00299804) Pharmacokinetics In Chinese Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      As part of the global clinical development program for Dacomitinib, studies are planned in
      cancer patients in China. An assessment of Dacomitinib pharmacokinetics in Chinese subjects,
      as required by the Chinese Health Authorities, is therefore warranted.

      The single 45 mg oral dose pharmacokinetics of Dacomitinib will be characterized.
    

Detailed description: 
      To evaluate the pharmacokinetics of Dacomitinib in Chinese healthy volunteers.
    

Intervention name(s): Dacomitinib
Intervention type(s): Drug
Intervention description(s): A single 45 mg oral dose of Dacomitinib will be administered under fasted conditions to healthy Chinese volunteers
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Dacomitinib; PF299804; pharmacokinetics; healthy; Chinese
Premedication by Midazolam for Emergency Surgery
Condition: Anxiety
MeSH terms: Emergencies; Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Preoperative anxiety is a subjective and painful experience and may have adverse
      psychological consequences and complicate anesthetic management. The aim of the study is to
      show the effect of premedication by midazolam on preoperative anxiety assessed by a visual
      analog scale and by measuring salivary cortisol levels. This study was a monocentric,
      prospective, blind randomized placebo controlled clinical study. Sixty patients, aged 18 to
      79 years, to undergo elective surgery under general anesthesia with tracheal intubation must
      be enrolled and randomized to receive midazolam (0.02mg/kg) or placebo. The primary outcome
      is the reduction in anxiety assessed by a visual analog scale. The secondary outcomes are the
      reduction in salivary cortisol levels, the overall level of anxiety and the evaluation of
      respiratory and hemodynamic adverse effects of midazolam.
    


Intervention name(s): placebo administration; midazolam intravenous administration
Intervention type(s): Drug; Drug
Other intervention name(s): isotonic saline serum intravenous administration; hypnovel
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: premedication; preoperative anxiety; salivary cortisol level; anxiety visual analog scale
Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Non-responder Genotype 2 Hepatitis C Infected Patients
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and
      Ribavirin (RBV) in patients with genotype 2 hepatitis C, who did not respond to previous
      treatment.
    


Intervention name(s): MP-424 (generic name:Telaprevir); Ribavirin; Peginterferon alfa-2b
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 750mg q8h for 12 weeks; 400 - 1000 mg/day based on body weight for 24 weeks; 1.5mcg/kg/week for 24 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Genotype 2
Effect of an Internet-based At-home Physical Training Protocol on Quality of Life, Fatigue, Functional Performance, Aerobic Capacity and Muscle Strength in Multiple Sclerosis Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      In this randomised controlled trial, the feasibility and effectiveness of an internet-based
      exercise intervention including progressive strength and endurance training (e-training) for
      PwMS was investigated. Primary outcome was health-related quality of life, secondary outcomes
      were muscle strength, aerobic capacity and lung function, physical activity and fatigue.
    


Intervention name(s): e-training; Control
Intervention type(s): Behavioral; Other
Intervention description(s): The e-training intervention is a home-based aerobic and resistance training program. Resistance training was prescribed twice weekly for a period of 12 weeks. No special equipment was necessary except an elastic exercise band or a large gymnastic ball. In addition, endurance training was to be carried out once a week. Training intensity was regulated by the participant's subjective, perceived exertion, which was rated between 6 and 20 on the BORG Scale. The form of activity for the endurance training was freely selected, duration (between 10-60 min) was adjusted to individual fitness levels. Therapists aimed at eliciting a BORG Feedback of between 11 (fairly light) and 16 (hard). The exercise training was home-based and supervised via the internet. Participants continued exercise training for another 12 weeks after the 3month assessment.; After the initial assessment on entry, those assigned to the control group were instructed to maintain their previous physical activity behaviour. After waiting three months, they received the same e-training intervention as the intervention group had received from the start.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Quality of Life; exercise; internet
Lidocaine Combined Dexmedetomidine for Obturator Nerve Block
Condition: Nerve Block
Study type: Interventional

Summary: 
      Hypothesis: Dexmedetomidine as an adjuvant of lidocaine can decrease the median effective
      concentration(EC50) of lidocaine for obturator nerve block during transurethral resection of
      bladder tumor
    

Detailed description: 
      A selective obturator nerve block(ONB) is an effective alternative to suppress the obturator
      nerve reflex which is defined as a sudden, violent adductor muscle spasm when the obturator
      nerve is stimulated directly by the electronic resector during transurethral resection of the
      tumor on the lateral bladder wall. Studies showed Dexmedetomidine as an adjuvant to local
      anesthetic prolongs peripheral nerve block duration without any nerve toxicity. In the
      following randomized, non-crossover study, the investigators test if Dexmedetomidine as an
      adjuvant can decrease the median effective concentration(EC50) of lidocaine for obturator
      nerve block during transurethral resection of bladder tumor.
    

Intervention name(s): Dexmedetomidine; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.; Normal Saline is administrated as an adjuvant of lidocaine.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dexmedetomidine; obturator nerve block; lidocaine; EC50
Dose-Response in PD and Safety of Cofact Under VKA Anticoagulation
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a randomized, open label, placebo-controlled, parallel design, single center,
      prospective study. Subjects will receive treatment with VKA. Subjects who reach the targeted
      INR, will receive single dose of Cofact. Multiple coagulation laboratory tests will be
      evaluated over a period of 15 days
    


Intervention name(s): Cofact
Intervention type(s): Biological
Intervention description(s): Human prothrombin complex concentrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Alogliptin Used Combination With 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: 
      The purpose of this study was evaluate the efficacy and safety of alogliptin, once dairy (QD)
      combined with metformin taken twice daily (BID) or three times daily (TID) in type 2 diabetic
      patients with uncontrolled blood glucose.
    

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.

      The present study was planned to evaluate the efficacy and safety of alogliptin as an add-on
      to metformin in type 2 diabetic patients who have uncontrolled blood glucose despite
      treatment with metformin as well as diet and exercise therapies.
    

Intervention name(s): Alogliptin and metformin; Alogliptin and metformin; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.; Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.; Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
Other intervention name(s): SYR-32; Glycoran; SYR-322; Glycoran; Glycoran
Intervention MeSH terms: Metformin; Alogliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus - Type 2; Diabetes Mellitus; Drug Therapy
Pharmacokinetics and Pharmacodynamics of Vicagrel in Healthy Adult Subjects of Different CYP2C19
Condition: Healthy Subjects; PK/PD
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single-center, randomized, open, two-cycle crossover, clopidogrel control,
      multiple dosing study. The aim was to evaluate the pharmacokinetic/pharmacodynamic behavior
      of different metabolites of CYP2C19 in healthy subjects. The study enrolled 48 patients,
      divided into three groups of CYP2C19 fast metabolite, middle metabolite, and slow metabolism,
      16 cases in each group. All groups of subjects were administered for 7 days in the first
      cycle, once a day (loading dose on the first day, maintenance dose on other days), and
      entering the 14-day washout period after the end of the first cycle. The second cycle was
      entered, and the second cycle was administered for 7 days, once a day (the first day was
      given a loading dose, and the other days were given a maintenance dose). Blood was collected
      before and after administration of D1, D7, D22, and D28, and PK/PD was measured.
    


Intervention name(s): Vicagrel 6mg; Clopidogrel 75mg
Intervention type(s): Drug; Drug
Intervention description(s): Vicagrel 24mg loading followed by 6mg/day for 6 days; Clopidogrel 300mg loading followed by 75mg/day for 6 days
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cognition Intervention Study PLUS (CogniDO PLUS)
Condition: Having Lunch; Omitting Lunch
Study type: Interventional

Summary: 
      Major aim of the Cognition Intervention Study Dortmund (CogniDo) was to add scientifically
      proven insights into cognitive effects of lunch to the existing recommendations for school
      meals in Germany. The Cognition Intervention Study Dortmund PLUS ties up to that aim. As an
      enhancement of CogniDo this study investigates the short-term effects of having school lunch
      versus skipping it on children's executive cognitive functions in the afternoon. The study
      was conducted in a comprehensive school in Gelsenkirchen (Germany) and included 215 children.
    

Detailed description: 
      Because of cerebral particularities, children may react highly sensitive to short-term
      variations of nutrient supply. Therefore, an optimised composition of meals at favourable
      mealtime should be considered for optimal cognitive performance. The increasing
      implementation of all-day schools in Germany requires the children's catering for lunch at
      school. However, the number of 'meal skippers' is increasing among children and adolescents.
      Thus, the effect of skipping lunch at school on cognitive functioning is examined in this
      experimental cross-over trial. As prior intake of food can have an influence on the
      physiological effect of test meal, the children's dietary intake in the mid-morning is
      standardized. The intervention is integrated in everyday school life:

      9.15 a.m. standardized snack within the frame of the regular break, 9.45 a.m. to 12.25 p.m.
      everyday school life, 12.25 p.m. either lunch (control) or water as a beverage (intervention
      of 'skipping meal'), 12.45 p.m. to 1.15 p.m. regular lunch break, 1.15 p.m. computerized
      tests of executive cognitive functioning, 2 p.m. lunch for the 'skipping meal'-group.
      Parameters of cognition with relevance to everyday school life are measured by a computerized
      test program developed by the Institute of Working Learning and Aging (Institut für Arbeiten
      Lernen Altern, ALA). Usual eating behaviour, sleep behaviour, physical activity and parental
      education were determined as control variables by questionnaires for children, parents.
      Migration background was requested from teachers. Body Mass Index was calculated based on
      measured height and weight.
    

Intervention name(s): Skipping lunch
Intervention type(s): Other
Other intervention name(s): Just water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
The Use of Piezoelectric Surgery for Osteotomies
Condition: Maxillofacial, Osteotomy
Study type: Interventional

Summary: 
      Piezo-surgery was ﬁrst used in oral and maxillofacial surgery in 2001 by Vercellotti and
      colleagues to simplify maxillary sinus surgery by avoiding perforation of the schneiderian
      membrane. Later on ultrasonic bone cutting has been used in orthognathic procedures,
      extraction of impacted third molars , cyst enucleation, implant site preparation,
      temporomandibular join surgery , corticotomy-facilitated orthodontics, and head and neck
      oncological and reconstructive surgeries.
    


Intervention name(s): Osteotomy using piezoelectrical device
Intervention type(s): Procedure
Intervention description(s): osteotomy were utilized using piezoelectric from device (Woodpeker) with its internal irrigation system. We used US2 tip using the maximum bone cutting program and maximum irrigation program for lateral maxillary wall osteotomy and USIR tip for the posterior maxillary wall osteotomy.
The pterygoid osteotome was placed between the tuberosity and pterygoid plates while the hamulus is palpated palatally with the index finger to guide the osteotome direction preventing palatal perforation.With the pterygoid osteotome still in position, we used a thin osteotome to complete the osteotomy of the posterior wall of the maxilla.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Impact of Reward-induced Dopamine Release on Functional Connectivity: a Combined PET/fMRI Study
Condition: Healthy
Study type: Observational

Summary: 
      The present study would be the first to investigate the relationship between reward- and or
      social stimuli-induced dopamine (DA) release and neural function using a combined PET/fMRI
      approach. Data from this project conducted in healthy subjects will provide preliminary data
      for a larger grant application to study patient populations with known abnormalities in DA
      including schizophrenia, major depressive, substance use, and eating disorders.
    

Detailed description: 
      Aim 1. To test the relationship between reward-induced dopamine (DA) release on changes in
      resting state functional connectivity (RSFC) in healthy subjects. In 20 healthy adults, the
      investigators will examine DA release (measured using positron emission tomography, PET) in
      the ventral striatum, thalamus, and prefrontal cortex, as previously described. Before and
      after the task the investigators will examine RSFC (measured using functional magnetic
      resonance imaging, fMRI) between these structures, which have been shown to form functional
      pathways serving motivation and emotion regulation in rodents and nonhuman primates. The
      investigators hypothesize that DA release will impact the functional relationship between
      these and other structures as determined by changes in RSFC.

      Aim 2. To examine the relationship between dopamine release and the Reward Positivity (RewP)
      potential. Subjects will be presented with the option to participate in an event-related
      potential (ERP) study. The investigators will correlate the amount of DA release with the
      amplitude of the RewP potential, an ERP that is enhanced in reward versus non-reward
      circumstances. Based on previous studies, the investigators hypothesize that RewP amplitude
      will positively correlate with dopamine release in the nucleus accumbens.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        20 subjects (ages 18-45 years) will be included. Male and female representation will be
        about equal. No ethnic/racial/gender group is excluded.
      
Keywords: PET; dopamine; fMRI; reward
Follicle Stimulating Hormone (FSH) Receptor Polymorphisms in In-Vitro Fertilization Cycles.
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      This study is being done to identify if certain sequences (patterns) of key genes (called
      polymorphisms) may predict a response to fertility medications. The investigators will also
      determine if the individual response to fertility medications affects pregnancy rates in
      in-vitro fertilization.
    

Detailed description: 
      All IVF patients who meet inclusion criteria and not exclusion criteria will be asked to
      participate in this study. Upon consent, a blood sample will be obtained in 2 EDTA containing
      lavender topped tubes before, during or within 3 months after their IVF cycle. Genomic DNA
      will be extracted and saved for genotyping.

      The Investigators will collect data on each individual's age, ethnic background, and
      estradiol levels on the day of hCG administration, total gonadotropin amount, clinical
      pregnancy rates, basal FSH levels, and occurrence of OHSS. The Investigators will then
      analyze all samples from all patients for their FSH receptor genotypes.

      Patients will be compensated $75 via a check within 6-8 weeks of their blood drawn.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing in-vitro fertilization will be recruited. Inclusion criteria will limit
        the patient population to those patients most likely to have normal ovarian function since
        age or disease related ovarian dysfunction will confound interpretation of our results.
      
Biospecimen description: 
      2 EDTA containing lavender topped tubes will be collected before, during or within 3 months
      after an IVF cycle. Genomic DNA will be extracted and saved for genotyping.
    
Keywords: Infertility; FSH Receptor Polymorphisms
Modifiers of Tenofovir in the Female Genital Tract
Condition: HIV/AIDS; Contraception
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Observational

Summary: 
      Two-armed, single visit, pharmacokinetic study to compare tenofovir diphosphate
      concentrations in cervical tissues of women on Depo-Provera contraception vs non-hormonal
      contraception.
    


Intervention name(s): Tenofovir Disoproxil Fumarate; Depo-Provera
Intervention type(s): Drug; Drug
Intervention description(s): Two cervical biopsies, blood plasma, PBMC, urine, and two cervicovaginal swabs will be collected at a single study visit; Two cervical biopsies, blood plasma, PBMC, urine, and two cervicovaginal swabs will be collected at a single study visit
Intervention MeSH terms: Tenofovir; Medroxyprogesterone Acetate; Medroxyprogesterone
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women will be recruited from an existing cohort.
      
Keywords: tenofovir; microbiome; inflammation