bioihbjkbjnl/mcl2 huggingface dataset:
Radiation Therapy and Chemotherapy in Treating Patients With Stage I Bladder Cancer
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized
      radiation therapy that delivers a high dose of radiation directly to the tumor may kill more
      tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as
      cisplatin, mitomycin C, and fluorouracil, work in different ways to stop the growth of tumor
      cells, either by killing the cells or by stopping them from dividing. Giving radiation
      therapy together with cisplatin may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well radiation therapy given together with
      chemotherapy works in treating patients with stage I bladder cancer.
    

Detailed description: 
      After completion of study treatment, patients are followed up every 3 months for 1 year,
      every 4 months for 1 year, every 6 months for 3 years, and annually thereafter until
      termination of the study.
    

Intervention name(s): cisplatin; 5-fluorouracil; Mitomycin; Three-Dimensional Conformal Radiation Therapy
Intervention type(s): Drug; Drug; Drug; Radiation
Intervention description(s): 60-minute intravenous (IV) infusion of 15 mg/m^2 on days 1, 2, 3, 15, 16, 17, 29, 30, and 31 of radiation treatment.; Continuous IV infusion of 500 mg/m^2/24 hrs for 5 consecutive days during weeks 1 and 4 of radiation treatment.; IV bolus dose of 12 mg/m^2 on day 1 of radiation treatment.; Total dose to the gross bladder volume of 61.2 Gy as 34 daily fractions 5 days/week, for approximately 7 weeks.
Other intervention name(s): 5FU; 3DCRT; 3D CRT
Intervention MeSH terms: Fluorouracil; Mitomycins; Mitomycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I bladder cancer; transitional cell carcinoma of the bladder
Safety, Tolerability and Pharmacokinetics of ERX-963 in Adults With Myotonic Dystrophy Type 1
Condition: Myotonic Dystrophy, Type 1 (DM1); Myotonic Dystrophy
MeSH terms: Myotonic Dystrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      Participants in this study will receive two treatments, placebo and ERX-963, on different
      days in a randomized fashion.

      The primary purpose of this study is to investigate the safety and tolerability of ERX-963 in
      participants diagnosed with Myotonic Dystrophy, Type 1 (DM1).

      The secondary purpose is to evaluate the potential of ERX-963 treatment to reduce excessive
      daytime sleepiness / hypersomnia and improve cognitive function in DM1 participants compared
      to placebo treatment.
    

Detailed description: 
      This study is evaluating single administration of two dose levels of ERX-963 to explore the
      relationship between dose, safety, tolerability, exposure and clinical benefit. This is a
      multi-center, randomized, double-blind, placebo-controlled, two-treatment period crossover
      study in two cohorts of participants with DM1.

      Participants who have consented and meet eligibility criteria will receive two treatments,
      placebo and ERX-963, in a randomized crossover fashion with a washout period between the
      treatments. On treatment days, participants will receive treatment followed by repeated blood
      collection for pharmacokinetic analysis and administration of a battery of outcome measures
      relevant to sleep and cognition.
    

Intervention name(s): ERX-963; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active medicine; Comparator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Excessive Daytime Sleepiness; hypersomnia
Pneumacare SLP Validation in Infants and in Clinical Bronchiolitis
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Observational

Summary: 
      A cohort observational study to characterise baseline Structured Light Plethysmography (SLP)
      outputs in infants with bronchiolitis and examine response to treatment using the Thora3DiTM
    

Detailed description: 
      Viral illness, particularly chest infection causing breathing difficulty in infants and
      children is the commonest reason for admission to hospital. At present, there are no
      objective measurements of the degree of breathing difficulty.

      This is because current objective tests of breathing difficulty requires the patient to
      cooperate and actively perform the tests. This is not possible in babies and very challenging
      in young children. SLP is a noncontact, effort independent technique for measuring the rate
      of breathing, the amount of chest expansion and the relative contribution of chest and
      abdomen to the work of breathing. Measuring these parameters which are known to vary with
      increasing breathing difficulty will allow us to make objective assessments of breathing
      difficulty. This study proposes to validate this technique in babies aged 02 years who are
      healthy and in babies with clinical viral bronchiolitis. The Investigators intend to
      demonstrate that the technique is feasible in this young age group and that the investigators
      will be able to demonstrate clinically valid differences between normal and ill babies and
      also demonstrate measurable differences with the evolution of the clinical illness.
    

Intervention name(s): Structured Light Plethysmography (SLP) - Pneumscan
Intervention type(s): Device
Intervention description(s): Both healthy infants and bronchiolitis infants will have their chest movements monitored using Structured Light Plethysmography (SLP) performed by a device (Thora-3 Di) using a projector and two cameras. A light pattern of black and white squares is projected on the child's chest and the cameras record how the shape of this pattern changes with breathing. A computer converts this information to show how the child's chest moves during breathing.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy infants aged 0-2 years and Infants aged 0-1 years with Bronchiolitis
Comparison of Anastrozole Verses Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile Women With Ovulatory Dysfunction
Condition: Anovulation
MeSH terms: Anovulation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate and compare the safety and efficacy of various
      doses of the aromatase inhibitor (anastrozole) versus clomiphene citrate in stimulating
      follicular growth and ovulation in infertile women with ovulatory dysfunction.
    


Intervention name(s): Anastrozole 1 mg; Anastrozole 5 mg; Anastrozole 10 mg; Clomiphene Citrate 50 mg; Clomiphene Citrate 100 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects will be administered orally with 1 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).; Subjects will be administered orally with 5 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).; Subjects will be administered orally with 10 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).; Subjects will be administered orally with 50 mg of clomiphene citrate once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).; Subjects will be administered orally with 100 mg of clomiphene citrate once daily for 5 days in Cycle 2 and 3 (each cycle = approximately 1 month).
Intervention MeSH terms: Anastrozole; Citric Acid; Sodium Citrate; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
What Effect Does Intubation Have on Regional Lung Ventilation?
Condition: Anesthesia
Study type: Observational

Summary: 
      During any general anaesthetic which involves muscle relaxation artificial breathing is
      required. This is most commonly provided by pushing air under pressure (positive pressure
      ventilation) into the lungs via a tube in the airway (the tracheal tube). It has been
      observed for many years that with this form of breathing the distribution of gas within the
      lungs differs from that seen during 'natural' breathing: more of the gas goes to the upper
      parts of the lung than lower parts. This change in how the gas is distributed can lead to
      problems with how well oxygen is taken up by blood and carbon dioxide removed from the body.
      Previous work using mathematical modelling has found that the position of the tracheal tube
      might affect air distribution, but this has previously been difficult to study in 'real
      life', requiring the use of radioactive dyes and computerised tomography (CT). However a
      bedside test is now available which allows us to study these changes rapidly and
      non-invasively, using electrical impedance tomography (EIT). The EIT device is commercially
      available (PulmoVista®, Draeger UK) and is used in hospitals worldwide as a bedside monitor
      of lung ventilation.

      This study aims to investigate the effect of tracheal intubation on regional ventilation of
      the lungs by comparing measurements before and after the patient is anaesthetised and
      intubated. The investgiators aim to show whether altered patterns of ventilation are caused
      by patients simply being asleep and ventilated, or whether these changes are due to the use
      of a tracheal tube itself. The exact effect of tube position will also be studied by
      measuring ventilation as the tube is deliberately advanced until it enters one of the lungs.
      This will give us information about the ideal position for a tube within the trachea to
      promote optimal ventilation patterns within the lungs
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients attending for a surgical procedure are eligible and will be approached.
Pilot Study of a Dietary Intervention Based Upon Advanced Glycation End Products
Condition: Healthy Adults
Study type: Interventional

Summary: 
      The purpose of this pilot study is to determine whether it is feasible to conduct a
      randomized, controlled dietary intervention trial of high versus low dietary intake of
      advanced glycation end products (AGEs) in 24 adults; and to gather preliminary data on the
      impact of high versus low AGE diet health parameters. The investigators hypothesize that it
      will be feasible to conduct a randomized, parallel arm, controlled dietary intervention in a
      pilot study involving 24 subjects.
    

Detailed description: 
      Advanced glycation end products (AGEs), bioactive molecules formed by the non-enzymatic
      glycation of proteins, are emerging as a possible dietary risk factor for many key adverse
      health outcomes related to obesity and to aging. Major sources of systemic AGEs are
      endogenous AGEs generated in the body and exogenous AGEs found in foods. When food is heated
      to high temperatures, the characteristic "browning" generates Maillard reaction products,
      known as AGEs. Although AGEs have been implicated in atherosclerosis, insulin resistance,
      diabetes, cardiovascular disease, aging-related eye disease, Alzheimer's disease, and chronic
      kidney disease, the possible adverse effects of dietary AGEs have not been well characterized
      in humans.

      The objective of the study is to determine whether it is feasible to conduct a randomized,
      parallel arm, controlled dietary intervention in a pilot study involving 24 subjects; and to
      compare the effects of a high-AGE and low-AGE diet on (a) serum and urine
      carboxymethyl-lysine and serum receptor for AGEs (RAGE), (b) endothelial function, (c)
      interleukin-6, C-reactive protein, (d) lipids, (e) adipokines, (f) glucose metabolism and
      insulin resistance, (g) renal function, and (h) cognition.
    

Intervention name(s): Dietary
Intervention type(s): Other
Intervention description(s): The diets will each consist of 3 meals/day and 1 snack/day which are either high or low in AGEs.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Novel Window of Opportunity Trial to Evaluate the Impact of Statins to Oppose Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This research study provides a novel opportunity to examine the intra-prostatic tumour
      inhibitory effects of statins in men with prostate cancer undergoing surgery.
    


Intervention name(s): Fluvastatin; Pimonidazole
Intervention type(s): Drug; Drug
Intervention description(s): HMG-CoA reductase inhibitors that lowers cholesterol levels. 40mg twice daily
Other intervention name(s): Lescol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to to Assess the Effect of Dapagliflozin When Administered Once a Day Versus Twice a Day on Blood Glucose
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to assess the effect of dapagliflozin on the amount of
      glucose in the blood and urine when dapagliflozin is administered once a day (10 mg) versus
      twice a day (5 mg every 12 hours) after five days of dosing.
    


Intervention name(s): Dapagliflozin; Dapagliflozin
Intervention type(s): Drug; Drug
Intervention description(s): Dapagliflozin tablets 5 mg, Oral Twice daily dose for 5 days (total daily dose 10 mg); Dapagliflozin tablets, 10 mg, Oral, once daily dose for 5 days
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy volunteers; Inhibition of glucose re-absorption; diabetes; dapagliflozin
Study on CRP Apheresis After Coronary Bypass Surgery
Condition: Post-cardiac Surgery
Study type: Interventional

Summary: 
      The CABY1 study is conducted open, controlled, randomized and monocentric. The efficacy and
      tolerability of CRP apheresis in patients undergoing elective primary coronary bypass surgery
      is investigated.
    

Detailed description: 
      CABY1 is a clinical trial to study the reduction of C-reactive protein (CRP) by therapeutic
      apheresis (CRP apheresis) in patients undergoing elective primary coronary bypass surgery.

      The term therapeutic apheresis describes therapeutical procedures whose effect is based on
      the elimination of blood components with a pathogenic function within the disease process.
      Elimination takes place in adsorbers outside the body in an extracorporeal circuit. To remove
      the pathogenic substances, blood plasma is separated from the circuit and passed through an
      adsorber. The purified blood plasma is then reunited with the solid blood components and
      returned to the patient.

      The "PentraSorb® CRP" adsorber used for CRP apheresis is CE-certified. It serves for the
      selective depletion of the C-reactive protein from human plasma.

      As a cause of the damaging effect of the C-reactive protein it is assumed that the CRP as an
      inflammatory mediator favours the destruction of cardiac muscle tissue (in conjunction with
      complement) and has a negative influence on the regeneration of the traumatized tissue.

      The aim of the CABY1 study is to investigate if the tissue damage of the heart can be reduced
      by depletion of the C-reactive protein after elective coronary bypass surgery. A possible
      protective effect of CRP apheresis will be determined from laboratory biomarkers (e.g.,
      troponin I, CM-MB, IL-6) and cardiac events.

      20 randomly selected patients receive apheresis treatments with a duration of 4-6 h each the
      following 2-3 days after bypass surgery, the 20 patients of the controls do not receive
      apheresis. The biomarkers required for the evaluation of the treatment success are determined
      over a period of 4 days after surgery on the basis of the routine blood tests. Cardiac events
      are documented until the patient is discharged.
    

Intervention name(s): CRP apheresis
Intervention type(s): Device
Intervention description(s): Selective CRP apheresis by use of the PentraSorb-CRP adsorber
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of this multicenter, randomized,
      double-blind, placebo-controlled, 4-period, incomplete-block crossover, dose-ranging study
      comparing 2 fixed dose combinations (FDCs) of aclidinium bromide with formoterol fumarate or
      with placebo, aclidinium bromide and formoterol fumarate, all administered twice a day (BID)
      in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD)
      beginning with a 2-week run-in period and with a 7-10 day washout each between treatment
      period.
    


Intervention name(s): Aclidinium 400 μg / Formoterol 12 μg; Aclidinium 400 μg / Formoterol 6 μg; Aclidinium 400 μg; Formoterol 12 μg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods.; Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods.; Aclidinium bromide 400 μg administered twice-daily (BID) for a 14 day period within four different treatment periods.; Formoterol fumarate 12 μg twice-daily for a 14 day period within four different treatment periods.; Placebo twice-daily delivered by inhalation for a 14 day period within four different treatment periods.
Intervention MeSH terms: Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Obstructive Pulmonary Disease; COPD; Chronic Bronchitis; Emphysema; Airflow Obstruction, Chronic; Chronic Airflow Obstruction; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease
Synbiotics and Gastrointestinal Function Related Quality of Life After Colectomy for Cancer
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The aim of this double-blinded prospective randomised trial is to explore the potential
      benefits of early postoperative administration of Synbiotics (combination of prebiotics and
      probiotics) to patients who have undergone colectomy for cancer. The patients are randomised
      to either synbiotics or placebo administration at the day they are able to tolerate po liquid
      diet and for 15 days thereafter.

      Primary end points of the study will be:

      Assessment of gastrointestinal function-related quality of life at 1, 3 and 6 months
      postoperatively by the use of the validated questionnaire GIQLI (Gastrointestinal Quality of
      Life Index)

      Secondary end points will be:

      -Assessment of functional bowel disorders (diarrhea, constipation, etc) at 1, 3 and 6 months
      postoperatively based on the respective domains of the validated instrument EORTC QLQ-C30
    

Detailed description: 
      The study patients are randomized before surgery to receive either synbiotics (Synbiotics
      group) or placebo (Control group). Equal randomization is accomplished using a
      computer-generated random allocation schedule. The method of allocation concealment is
      sequentially numbered sealed opaque envelopes technique. Both synbiotics and placebo
      preparations are in foil-sealed sachets stored in identical numbered containers. Both study
      products are white powders, identical in weight, smell, and taste. Thus, the identity of the
      specific product is blind to participants, support staff and investigators for the entire
      duration of the study period.
    

Intervention name(s): Synbiotics; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 12 gr in 250 cc of water once daily X 15 days; 12 gr in 250 cc of water once daily X 15 days
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Sebum Excretion in Neonates of Women With Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      To investigate whether women with polycystic ovary syndrome who are post-partum excrete
      higher levels of sebum in comparison to healthy controls due to high levels of androgens.
    

Detailed description: 
      First degree relatives of women with PCOS have a 3-4 fold increased prevalence of the
      syndrome compared with the general population, suggesting an inherited genetic
      predisposition. Many investigations into possible candidate genes for PCOS susceptibility
      have hypothesised the incomplete penetrance of a dominant gene, although no consensus has
      been achieved as to any exact genetic polymorphisms which may be culpable.

      Primate studies have offered credence to the theory that genomic imprinting is influenced by
      environmental hyperandrogenism and the hypothesis of intra-uterine exposure to excess
      androgens as a cause of PCOS is gaining momentum (Abbott et al, 2010). At birth, both mother
      and neonate are influenced by an identical hormone profile, and it is therefore expected that
      sebum excretion rates (a correlate of androgen excess) will be higher in those neonates born
      to mothers with PCOS when compared to those without. This would account for the observed
      familial transition of PCOS (Legro et al, 1998; Vink et al, 2006), and support the hypothesis
      that in-utero hyperandrogenism primes differentiating tissues for later expression of the
      PCOS phenotype in adolescence.
    

Intervention name(s): Sebutape
Intervention type(s): Other
Intervention description(s): Women who consent to the study will have a sebutape attached to their and their babies foreheads to measure the levels of androgens.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic