bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study Assessing Breast Temperature in Breast Cancer Patients
Condition: Breast Reconstruction
Study type: Interventional

Summary: 
      Our investigators plan to measure the skin on the breast six months after breast
      reconstruction. The non-reconstructed breast will be used as the control for subject with
      unilateral reconstruction only. For those who have BILATERAL reconstruction, a core
      temperature will be obtained from the ear.
    

Detailed description: 
      Many factors influence outcomes following mastectomy and breast reconstruction. Cutaneous
      sensation, degree of scar formation, nipple projection and overall appearance are well
      correlated with patient satisfaction. However, very little data exists on the importance of
      skin temperature after mastectomy and reconstruction. Our investigators have noted that a
      number of patients report their reconstructed breast is cold and relate this as a source of
      dis-satisfaction. In these patients, it is unclear if 1) the reconstructed breast skin is
      cold and if so 2) can something can be done to improve this. Our investigators hypothesize
      that cutaneous breast temperature may be altered after mastectomy and reconstruction. This
      may be dependent on the reconstruction technique and other patient factors. In this pilot
      study, our investigators aim to establish techniques for evaluating cutaneous breast
      temperature following mastectomy and reconstruction. Our investigators hope to establish
      baseline data to develop an understanding of breast skin temperature after mastectomy and
      reconstruction.

      Our long-term goals are to evaluate how cutaneous breast temperature may contribute to
      patient satisfaction. Our investigators also hope to determine which patients are at risk for
      developing a cold breast after surgery. Finally, our investigators will setup a prospective
      trial evaluating techniques to correct this problem and improve patient satisfaction.
    

Intervention name(s): Temperature measurement of breast
Intervention type(s): Other
Intervention description(s): Multiple measurements will be obtained from the ear, chest, breast, abdomen, and hands.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Determine skin temperature after breast reconstruction
Masking: None (Open Label)
Primary purpose: Treatment
Treatment With BIBW 2992, Irreversible Inhibitor of EGFR and HER-2 in Non-small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer; EGFR; HER-2
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with stage IIIB and IV lung adenocarcinoma and progression to first-line
      chemotherapy were enrolled to receive afatinib 40 mg/day. Mutational EGFR and HER-2 status
      were assessed by RT-PCR. HER2 amplification was evaluated by FISH. Plasma HGF levels were
      measured by ELISA before and 2 months (mo) after the start of treatment. We assessed changes
      in serum HGF levels and their association with objective response rate (ORR), PFS and overall
      survival (OS).
    

Detailed description: 
      Lung cancer is the main cause of cancer-related mortality worldwide, accounting for 1.6
      million deaths in 2012. Non-small-cell lung cancer (NSCLC) histology comprises ap-proximately
      85% of cases. At the time of diagnosis, 75% of the patients have locally advanced or
      metastatic disease, with a 5-year survival rate of less than 5%. Although treatment options
      for these patients remain limited, drugs targeting the epidermal growth factor receptor
      (EGFR) have proved to be a highly effective therapy in NSCLC patients harboring sensitizing
      EGFR mutations.

      Afatinib, a second-generation irreversible TKI, confers a theoretical advantage over
      re-versible TKIs in patients with acquired resistance. Through covalent binding to the kinase
      domain of EGFR, afatinib down regulates signaling from all homodimers and heter-odimers
      formed by ERBB receptor family members including EGFR, HER2 (ErbB2), HER3 (ErbB3) and HER4
      (ErbB4). HER2 mutations in NSCLC are rare, being found in approximately 1-4% of lung
      adenocarcinomas.

      In contrast with reversible TKIs, the mechanisms of resistance to irreversible TKIs have not
      been fully elucidated, and identification of biomarkers that predict response to these drugs,
      particularly in patients progressing after first line therapy, is needed. In this study we
      assess the usefulness of plasma HGF concentrations as a predictor of response to afatinib in
      patients with advanced-stage lung adenocarcinoma.
    

Intervention name(s): BIBW 2992
Intervention type(s): Drug
Intervention description(s): All patients will receive: BIBW 2992 40mg every 24 hours orally, where a cycle corresponds to complete this treatment for 28 days; option 30mg/day dose reductions, according to established criteria.
Not to be compared with any other drug.
Other intervention name(s): Afatinib
Intervention MeSH terms: Afatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-Small Cell Lung Cancer
Diazepam and Blood Pressure Regulation
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of this study is to determine the acute effects of diazepam on beat-to-beat blood
      pressure variability and baroreflex control.
    

Detailed description: 
      Benzodiazepines are widely prescribed for a variety of clinical conditions. However, its
      cardiovascular consequences remain controversial. In this study, the investigators sought to
      determine the acute effects of a single dose of oral diazepam (10mg) on resting beat-to-beat
      blood pressure variability and cardiac and sympathetic baroreflex sensitivity in a cohort of
      young, healthy individuals.
    

Intervention name(s): Diazepam
Intervention type(s): Drug
Intervention description(s): Oral administration of 10 mg of diazepam
Intervention MeSH terms: Diazepam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Blood pressure; Benzodiazepine; Autonomic nervous system
Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase III trial of LHRH analog administration during chemotherapy to reduce ovarian
      failure following chemotherapy in early stage, hormone-receptor negative breast cancer.
    


Intervention name(s): Standard cyclophosphamide; Goserelin (Zoladex)
Intervention type(s): Drug; Drug
Intervention description(s): AC (3 mos/4 cycles), CAF (6 mos/cycles), TAC (6 mos/cycles), CEF (6 mos/cycles) AC followed by taxane (6 mos/8 cycles), CMF (6 mos); Chemotherapy in Arm 1 plus Goserelin given one week before first chemotherapy dose. Goserelin is given once every 4 weeks during chemo
Intervention MeSH terms: Cyclophosphamide; Goserelin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Early Stage Breast Cancer; Reduce Ovarian Failure Following Chemotherapy
Antenatal Breastmilk Expression From Week 34 of Gestation
Condition: Breastmilk Expression; Collection, Breastmilk; Breastfeeding; Healthy
Study type: Interventional

Summary: 
      In this pilot study, the investigators aim to examine if antenatal breastmilk expression from
      week 34 of pregnancy is a safe and feasible procedure for the mother and fetus. Furthermore,
      the investigators want to evaluate breastfeeding rates.
    

Detailed description: 
      In a randomized pilot study, 60 healthy pregnant women will be randomized either to antenatal
      breastmilk expression from week 34+0 until delivery or no antenatal breastmilk expression.
      Furthermore, all participants will have an individual breastfeeding consultation with a
      trained midwife in week 33 of pregnancy. At the consultation, the intervention group will
      also be taught how to perform antenatal expression by hand and store any expressed breastmilk
      correctly. All women included in this study will receive standard care.

      To detect signs of uterine contractions or fetal reaction in relation to stimulation of the
      breast, a cardiotocography (CTG) will be performed before, during and after the first
      expression in the intervention group. If the CTG is normal the women can perform breastmilk
      expression by hand 5 minutes at each breast two times per day until birth, and collect and
      store any expressed milk.

      During the intervention and 8 weeks after birth the participating women will receive weekly
      push-messages through an application on their smartphone. The messages include short
      questions about the handexpression of milk in pregnancy as well as regarding feeding of the
      infant after birth. At the end of the study the mothers will be invited for an interview to
      investigate their experience with the procedure, but this is an independent study and
      therefore not a part of this protocol.
    

Intervention name(s): Antenatal breastmilk expression; Breastfeeding consultation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Stimulation of the breast by hand/handexpression of breastmilk during pregnancy from week 34; 60 min standardized breastfeeding consultation with a trained midwife, with focus on practical breastfeeding skills
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Infant nutrition; Lactation; Breastmilk; Breastfeeding
Comparison of Two Insulin Detemir Formulations in Healthy Volunteers
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to compare two formulations of
      insulin detemir containing an isotonic agent in healthy volunteers.
    


Intervention name(s): insulin detemir; insulin detemir
Intervention type(s): Drug; Drug
Intervention description(s): Single dose containing mannitol as isotonic agent. Administered subcutaneously (s.c., under the skin); Single dose containing glycerol as isotonic agent. Administered subcutaneously (s.c., under the skin)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Detemir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of Orientation and Visual Acuity of Four Toric Soft Contact Lenses When Head is Tilted at 90 Degrees
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      The purpose of this study is to determine the relative performance of a new toric soft
      contact lens against three toric contact lens currently available in market, specifically
      with orientation and visual acuity when head is tilted at 90 degrees.
    

Detailed description: 
      Non-dispensing single-masked (subject-masked), randomised, 1-visit controlled study, ~2 hour
      duration.
    

Intervention name(s): senofilcon A; balafilcon A toric; lotrafilcon B toric; omafilcon A
Intervention type(s): Device; Device; Device; Device
Intervention description(s): toric contact lens; toric contact lens; toric contact lens; toric contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: astigmatism; orientation; visual acuity; contact lenses
A Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis.
Condition: Myasthenia Gravis Generalised
MeSH terms: Myasthenia Gravis; Muscle Weakness
Study type: Interventional
Phase: Phase 3

Summary: 
      This 2 arm study will provide optional continuation of double-blind treatment with CellCept
      or placebo, in patients with myasthenia gravis who have achieved good symptom control in
      study WX17798. Patients who have completed 36 weeks of treatment in study WX17798, with
      stable prednisone dosing for the last 4 weeks, can continue on blinded treatment with
      CellCept (1g bid) or placebo until the database for WX17798 is locked and unblinded. The
      anticipated time on study treatment is 3-12 months, and the target sample size is 100-500
      individuals.
    


Intervention name(s): mycophenolate mofetil [CellCept]; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1g po bid; po bid
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Safety Study of Balsamic Bactrim in Pediatric Participants With Acute Bronchitis
Condition: Bronchitis
MeSH terms: Bronchitis; Acute Disease
Study type: Observational

Summary: 
      This pilot, multicentric and observational study will assess the safety of sulfamethoxazole +
      trimethoprim + guaifenesin (Balsamic Bactrim) in pediatric participants with acute
      bronchitis. Administration of treatment will be according to treating physician's
      recommendation under local labeling.
    


Intervention name(s): Guaifenesin; Sulfamethoxazole; Trimethoprim
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.; Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.; Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.
Intervention MeSH terms: Trimethoprim; Sulfamethoxazole; Phenylpropanolamine; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric participants receiving treatment for acute bronchitis with Balsamic Bactrim
        according to standard of care and in line with the current summary of product
        characteristics (SPC) / local labeling and who have no contraindication to Balsamic Bactrim
        as per the local label.
Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy to Treat Lung Cancer
Condition: Non-small Cell Lung Cancer; Squamous Cell Carcinoma
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This randomized, multicenter,open-label phase II/III study is to evaluate the effects of
      chemotherapy combination with autologous cytokine-induced killer Cell immunotherapy in
      patients with stage IIIb-IV squamous non-small-cell lung cancer
    

Detailed description: 
      1. Phase II/III study,

        2. Randomized, multicenter, open-label study,

        3. Evaluated the effects of chemotherapy combination with autologous cytokine-induced
           killer Cell immunotherapy compared with chemotherapy in patients with stage IIIb-IV
           squamous non-small-cell lung cancer
    

Intervention name(s): CIK cell; Gemcitabine Injection; Cisplatin injection
Intervention type(s): Biological; Drug; Drug
Intervention description(s): CIK cell injection; Gemcitabine injection; Cisplatin injection
Other intervention name(s): Cytokine-induced killer cell; Gemcitabine; Cisplatin
Intervention MeSH terms: Cisplatin; Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy Subjects
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of
      oral doses of FB-101 in healthy subjects.
    

Detailed description: 
      Part A

        -  To assess the safety and tolerability of single ascending oral doses of FB-101 in
           healthy subjects.

        -  To assess the pharmacokinetics (PK) of single ascending oral doses of FB-101 in healthy
           subjects.

        -  To assess the effect of a high-fat meal on the PK of a single oral dose of FB-101 when
           administered to healthy subjects.

      Part B

        -  To assess the safety and tolerability of multiple ascending oral doses FB-101 in healthy
           subjects.

        -  To assess the PK of multiple ascending oral doses of FB-101 in healthy subjects.
    

Intervention name(s): FB-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Part A - Single Ascending Dose study Part B - Multiple Ascending Dose study; Part A - Single Ascending Dose matching placebo study Part B - Multiple Ascending Dose matching placebo study
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Evaluation of Metronidazole Hydrogel 25% in Stage II and III Periodontitis
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized clinical trial will be performed single-blind to evaluate the effectiveness of
      sublingual metronidazole hydrogel 25 % in periodontitis.
    

Detailed description: 
      A randomized clinical trial will be performed single-blind to evaluate the effectiveness of
      sublingual metronidazole hydrogel 25 % in periodontitis in stage II and III.

      At least 40 volunteers between the age of 18 and 80, will be enlisted, with the need to
      perform the SRP. In half of the mouth will be used the metronidazole hydrogel 25%, while in
      the other half no drugs will be used of delivered.

      The study will be carried out in accordance with the Helsinki Declaration and the Protocol
      will be submitted to the Internal Review Board of the University to obtain authorization.
      Afterwards, the protocol will be recorded on the databa-se clinicaltrials.gov for clinical
      trials.

      The protocol respects the SPIRIT parameters for the compilation of protocols on clinical
      trials and the study will respect the parameters of CONSORT sta-tement on randomized clinical
      trials.
    

Intervention name(s): metronidazole hydrogel; scaling and root planning
Intervention type(s): Drug; Procedure
Intervention description(s): scaling and root planning in adjunct to the use of metronidazole in the periodontal pocket; scaling and root planning
Other intervention name(s): Non Surgical Periodontal Therapy
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Periodontitis; Periodontal disease
Menopausal Sleep Fragmentation and Body Fat Gain
Condition: Menopause
MeSH terms: Sleep Deprivation
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to investigate the impact of menopause-related sleep fragmentation on
      metabolic biomarkers of body fat gain. The investigators hypothesize that experimental sleep
      fragmentation will result in an adverse leptin response as a metabolic biomarker for body fat
      gain.
    

Detailed description: 
      While obesity is highly prevalent in midlife and older women, with rates increasing markedly
      after age 40 and body fat increasing in half of women during and after the menopause
      transition, factors causing these changes are not well understood. Reduced total sleep time
      has been shown to adversely impact biomarkers of obesity, but the effect of the highly
      prevalent menopause-related sleep fragmentation secondary to hot flashes on metabolism and
      eating behaviors in humans is not known. We will use experimental paradigms to isolate the
      impact of menopause-related sleep disruption, as well as that of hot flashes and estrogen
      withdrawal, metabolic biomarkers of body fat gain and on eating behaviors, results of which
      will inform strategies to prevent body fat gain and improve cardio-metabolic health outcomes
      in women.
    

Intervention name(s): Estradiol withdrawal; Fragmented sleep
Intervention type(s): Drug; Other
Intervention description(s): one injection of open-label intramuscular dose of leuprolide (3.75-mg depot), a gonadotropin-releasing hormone agonist that rapidly suppresses estradiol and temporarily achieves ovarian suppression.; Fragmented sleep will be experimentally induced.
Other intervention name(s): Leuprolide Acetate; Lupron
Intervention MeSH terms: Leuprolide; Estradiol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: menopause; sleep fragmentation; leuprolide; adipokine; weight gain; leptin
Multi-dimensional Investigations of Negative Emotions and Drug-resistant Auditory Verbal Hallucinations in Psychosis
Condition: Schizophrenia Spectrum and Other Psychotic Disorders; Hallucinations, Auditory
MeSH terms: Hallucinations; Schizophrenia; Psychotic Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders
Study type: Observational

Summary: 
      Auditory verbal hallucinations (AVH) are commonly reported as source of distress, disability
      and mortality in schizophrenia. Despite proven efficacy of antipsychotics, many patients
      still experience drug-refractory AVH. It has been postulated that AVH is maintained by
      negative emotions. Yet, little is known about the temporal relationship and underlying
      mechanisms between negative affect and AVH. Utilizing both an ecologically-validated method
      and brain imaging technique, this study aims to uncover the role of emotions in the
      maintenance of psychotic symptoms.
    


Observational model: Case-Only
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients, including in-patients, out-patients and day hospital patients, will be recruited
        from psychiatric units of multiple hospital sites.
      
Keywords: Auditory hallucinations; Psychosis; Mood; Brain imaging; Experience sampling method
Study to Assess the Effects and Safety of ZGN-1061 in Overweight and Obese Participants With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus; Overweight and Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of the study drug ZGN-1061
      in participants with type 2 diabetes.
    

Detailed description: 
      Participants will be enrolled in 1 of 2 groups. Approximately 120 participants will receive
      0.05, 0.3, or 0.9 mg of ZGN-1061 or placebo (Group 1). An additional 40 participants will
      receive 0.9 or 1.8 mg of ZGN-1061 or placebo (Group 2).
    

Intervention name(s): ZGN-1061; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ZGN-1061 is a methionine aminopeptidase 2 inhibitor; Placebo has the same excipients and appearance as ZGN-1061
Intervention MeSH terms: ZGN-1061
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Methionine Aminopeptidase 2 Inhibitor; Diabetes Mellitus, Type 2; Blood Glucose; Overweight; Obesity