bioihbjkbjnl/mcl2 huggingface dataset:
Validation of a Newly Developed Liquid Jet Aesthesiometer
Condition: Ocular Surface Disease
Study type: Observational

Summary: 
      A new liquid jet aesthesiometer prototype was developed with the aim to measure ocular
      surface sensitivity by employing a liquid jet.

      This study aims to validate this new prototype by means of correlating its measurement with a
      previously validated air jet aesthesiometer, the non-contact aesthesiometer (NCCA; by Murphy
      et al. 1996) and by exploring the repeatability of ocular surface sensitivity measurement.
    

Detailed description: 
      Currently, no aesthesiometer is available that delivers reliable and repeatable measurement
      of ocular surface sensitivity in a routine clinical setup. The only commercially available
      Cochet- Bonnet aesthesiometer uses a tactile-mechanical stimulus (the tip of a nylon thread),
      which can cause a microerosion when applied to the corneal surface. Additional disadvantages
      represent poor stimulus reproducibility, a limited stimulus bandwidth and the influence of
      humidity and age on the bending capibility of the nylon thread. For research purposes
      prototypes of non-contact air aesthesiometers (eg by Murphy et al. and Belmonte et al) are
      being used.

      This study aims to correlate ocular surface sensitivity measurements of a newly developed
      prototype, the liquid jet aesthesiometer, with the non-contact air jet aesthesiometer by
      Murphy et al. 1996 and to explore its repeatability of measurement.

      In this repeated measures design 60 subjects participate in corneal sensitivity measurements
      during two appointments with each described aesthesiometer.
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        30 healthy subjects within age range of 18-30 years 30 healthy subjects within age range of
        50-65 years
      
Keywords: ocular surface sensitivity
Tube Tip Position in Orally Intubated 0-4year Old Children: Assessment of the Precision of Two Clinical Techniques
Condition: Intubation, Endotracheal
Study type: Interventional

Summary: 
      In pediatric anesthesia it is very important to place the endotracheal tube into the right
      position. This study compares two clinical location methods. The hypothesis means that the
      two techniques have the same precision of the location of the tip position of a cuffed
      MICROCUFF (Kimberly-Clark)endotracheal tube.
    

Detailed description: 
      Appropriate location of the tip of an endotracheal tube (TET), in relation to the carina and
      vocal cords, is of great importance in pediatric anesthesia. A not optimal laying tube causes
      life threatening consequences. Therefore, it is very essential to have reliable methods how
      to place the tube tip in regard of the precision of the localisation. There are no
      standardized methods how to accomplish a precise position. The study compares two most
      applied techniques. The first one is the cuff palpation technique (CPT), the second one the
      deliberate right mainstem intubation technique (RMT).
    

Intervention name(s): Anesthesia induction; Anesthesia induction
Intervention type(s): Procedure; Procedure
Intervention description(s): Cuff palpation technique: identification of the cuff position in the trachea by palpation.; Right mainstem intubation, identification of the tube tip position in the trachea by withdrawing the tube from the right mainstem until good quality breath sound in the left axilla are available.
Other intervention name(s): Pediatric endotracheal tube. Microcuff, Kimberly-Clark.; Pediatric endotracheal tube, Microcuff, Kimberly-Clark
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: evaluating precision of tube tip position with two methods
Modified Relaxation (MR) Technique for Treating Hypertension in Postmenopausal Women
Condition: Postmenopausal Syndrome; Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate better effectiveness of modified relaxation (MR)
      technique over no MR for treating hypertension in Thai postmenopausal women.
    

Detailed description: 
      Medical treatment of hypertension (HTN) in postmenopausal women is not very effective, as it
      requires co-operation and long-term commitment from the patients and their families. The
      medication itself may cause bothersome side effects and it can pose economic burden to the
      patients and the society. In contrast, lifestyle modifications, particularly relaxation
      technique, are less costly and relatively free of any side effects. Once the patients master
      the techniques, they can practice by themselves at home and at any time that is convenient to
      them. There is evidence from at least one RCT that the techniques are effective in reducing
      the systolic blood pressure (SBP) and diastolic blood pressure (DBP), even after a short
      practice of only two months.

      In this study, the investigators propose a randomized control trial to examine the
      effectiveness of modified relaxation (MR) technique to control HTN in Thai postmenopausal
      women against a control group who practice no MR. Such a study in Thai population has not
      been done before. In addition, the investigators will extend the period of observation up to
      16 weeks, to assess longer-term patients' compliance, and the effects of MR on BP.
    

Intervention name(s): Modified Relaxation (MR); Lifestyle Education (LE)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Modified Relaxation (MR) This technique intend to train participants in a group of 8-10 in only 1 session that lasts 60 minutes. After completing the training, participants will be given a hand-out on MR. They will be asked to practice MR at home once a day for 15-20 minutes during their leisure times, for at least 5 days a week during the whole 16 weeks of the study period.; Participants in this group will receive conventional care and lifestyle education on dietary choice and exercise.
Other intervention name(s): Behavioral Relaxation; Lifestyle Modification
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: postmenopause; hypertension; relaxation; SBP 140-159 mmHg; DBP 90-99 mmHg; stage 1 or mild hypertension
Phase II/III Trial of CPT-11/5-FU/l-LV Versus CPT-11/TS-1 as Second Line Chemotherapy of Unresectable Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is designed as Phase II/III. Phase II is aimed to evaluate safety and efficacy of
      IRIS, and feasibility of FOLFIRI. Phase III is aimed to verify inferiority of the progression
      free survival of IRIS in comparison with FOLFIRI.
    


Intervention name(s): CPT-11 and TS-1; CPT-11, 5-FU and l-LV
Intervention type(s): Drug; Drug
Intervention description(s): TS-1 was administered orally at 40-60 mg twice daily for 14 days with a rest period of 14 days as one course. CPT-11 was administered intravenously 125 mg per square meter at day1 and day14 in 4 weeks as one course.; Patients were administered FOLFIRI every 2 weeks in one course. FOLFIRI:CPT-11 150 mg per square meter on day1 with l-LV 200 mg per square meter administered as a 2-hour infusion before 5-FU 400 mg per square meter administered as an intravenous bolus injection, and 5-FU 2400 mg per square meter as a 46-hour infusion immediately after 5-FU bolus injection on day1 in 2 weeks.
Intervention MeSH terms: Irinotecan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colorectal Cancer
HEPMET-1: Evaluate the Feasibility, Mental Sideeffects and the Efficacy of Hepatitis C Treatment in a MMT Group.
Condition: Opiate Dependence; Hepatitis
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      -  To evaluate if weekly psychological follow-up make opioid dependent patients in MMT able
           to accomplish 14 weeks treatment with Peginterferon alfa-2a (PEG-INF) and ribavirin to
           the same extent than non-opioid dependents.

        -  To determine the efficacy of this anti-HCV treatment
    

Detailed description: 
      Chronic infection with the hepatitis C virus (HCV) is a health problem worldwide. In Norway,
      there are about 3000 patients participating in Methadone Maintenance Treatment(MMT) programs.
      A prevalence study at the MMT treatment unit in Kristiansand, showed that more than 90 % of
      177 patients have been infected with hepatitis C.

      A major problem with anti-HCV treatment for this group is the lack of compliance and
      retention in treatment. Further, due to the high incidence of psychological disorders in
      opioid dependent patients, this may also complicate anti-HCV treatment. Drug addicted in MMT
      treatments programs may find themselves excluded from Hepatitis C treatment.

      Due to better treatment efficacy with the new PEG-INF's and encouraging reports from 14 weeks
      studies, it may be easier to motivate opioid dependents to fulfill treatment. Weekly
      psychological follow-up of these patients will further increase the possibility of opioid
      dependents in MMT to be able to complete anti-HCV treatment.

      The aim of this study is to focus on this patients situation, and strengthen their
      possibility to have a real opportunity to get treatment. We therefore wish to make a pilot
      study to investigate the feasibility, efficacy and psycological side-effects of the
      treatment.
    

Intervention name(s): Ribavirin; Pegylated Interferon
Intervention type(s): Drug; Drug
Intervention description(s): 800 mg pr. os daily, 400 mg morning and 400 mg evening (200 mg/tbl.) for 14 weeks; 180 mikrogram in 0,5 ml solution s.c. once a week for 14 weeks
Intervention MeSH terms: Interferons; Ribavirin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronical Hepatitis C treatment; Methadone Maintenance Treatment; Pegylated Interferon and Ribavirin; 14 weeks treatment; Genotype 2 and 3
Clinical Pharmacology Study of MRA in Patient With Rheumatoid Arthritis (RA) With Renal Impairment
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      This is an open-label, clinical pharmacology study to evaluate the safety and PK of MRA in
      patients with RA with Renal Impairment.
    


Intervention name(s): MRA(Tocilizumab)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I/II Study of Immune Therapy After Allograft in Patients With Myeloid Hemopathy
Condition: Acute Myeloid Leukemia; Chronic Myeloid Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Patients with acute or chronic myeloid leukemia, or myelodysplastic syndrome, underwent
      allogeneic stem cell transplantation from HLA-identical donor (related or unrelated) after
      reduced-intensity conditioning regimen.

      If WT1 expression is detectable on tumor cells, they will receive an immune therapy 60 days
      after allograft.

      6 administrations every 2 weeks of the protein recwt1-A10+AS01B will be administrated.

      The safety and immunological efficacy of this immune therapy after hematopoietic stem cells
      transplantation with reduced intensity conditioning will be evaluated.
    


Intervention name(s): recwt1-A10+AS01B
Intervention type(s): Biological
Other intervention name(s): immune therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute myeloid leukemia; chronic myeloid leukemia; myelodysplastic syndrome; allograft; WT1 expression
Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase II clinical research study to evaluate the efficacy and safety of two different dose
      levels of an injectable investigational treatment (ACC-001) in subjects with Mild-to-Moderate
      Alzheimer's disease. ACC-001 (vanutide cridificar) is a beta amyloid fragment attached to a
      carrier protein. It is intended to help induce an antibody response against beta amyloid and
      is administered as an intramuscular injection.
    


Intervention name(s): ACC-001 (vanutide cridificar)
Intervention type(s): Biological
Intervention description(s): Comparisons of 2 different doses of ACC-001 or placebo for 24 months
Other intervention name(s): vanutide cridificar
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mild to moderate Alzheimer's disease; immunization; amyloid imaging; injection; vaccine
The Use of GnRH Agonist Trigger in the Prevention of OHSS
Condition: Ovarian Hyperstimulation Syndrome
MeSH terms: Ovarian Hyperstimulation Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the incidence of ovarian hyperstimulation syndrome (OHSS) and implantation rate
      between high responder patients using Gonadotropin releasing GnRH) agonist or human chorionic
      gonadotropin (hCG) to trigger final oocyte maturation.
    

Detailed description: 
      OHSS is an iatrogenic complication of controlled ovarian hyperstimulation, which in its
      severe form, may result in significant morbidity. Although, there have been significant
      advances in in-vitro fertilization (IVF) protocols over the years, the incidence of OHSS have
      remained stable and there is currently no effective way of preventing this disorder.

      hCG is commonly used as a substitute for the endogenous LH surge to induce final oocyte
      maturation in IVF. Unfortunately, hCG results in a prolonged luteotropic effect because of
      its long half-life which may result in a potential risk of OHSS in high-risk patients. In
      contrast, induction of endogenous LH surge with a GnRH agonist may result in a reduced risk
      of OHSS. This is due both to the shorter half-life of the endogenous LH surge and the
      subsequent pituitary suppression leading to early luteolysis. However, previous studies have
      suggested that this approach may impair implantation rates.

      There are no randomized studies assessing the effect of GnRH agonist to induce oocyte
      maturation on the occurrence of OHSS and implantation rates in high-risk patients. The aims
      of this study are to compare the incidence of OHSS and implantation rates among high-risk
      patients who used either GnRH agonist or hCG to trigger oocyte maturation after prevention of
      premature LH surge with either a GnRH antagonist protocol or the dual pituitary suppression
      protocol, respectively.

      High risk patients include women with polycystic ovarian syndrome (PCOS) or PCO morphology
      (PCOM) on ultrasound without the clinical or biochemical evidence of the syndrome, and
      patients with previous high response to gonadotropins.
    

Intervention name(s): Leuprolide acetate
Intervention type(s): Drug
Intervention MeSH terms: Leuprolide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: OHSS; PCOS; Previous high response; GnRH antagonist; GnRH agonist; IVF
Cross-over Study to Evaluate the Rate and the Extent of Iron Absorption of an ODF Iron Supplement vs an Iron Supplement in Capsules
Condition: Iron-deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      Open, monocentric, comparative, cross-over study to evaluate the rate and the extent of iron
      absorption after a single oral dose of (A) IBSA Iron orodispersible film vs (B) SiderAL®
      FORTE capsules in healthy women aged 18 to 55 years.
    

Detailed description: 
      Open, monocentric, comparative cross-over study to compare the rate and the extent of iron
      absorption after a single oral dose of (A) IBSA Iron orodispersible film vs (B) SiderAL®
      FORTE capsules in healthy women aged 18 to 55 years.

      IBSA Iron is a food supplement based on ferric pyrophosphate and folic acid in orodispersible
      film.

      SiderAL® FORTE is a preparation based on ferric pyrophosphate and Vit.C in capsules.

      Each subject will be observed for two consecutive days (phase I, day -1 and day 0) and after
      a 7-day washout (phase II) for an additional two consecutive days (day -1 and day 0). Half of
      the enrolled subjects will take A in phase I and B in phase II; the remaining half of the
      enrolled subjects will take B in phase I and A in phase II.

      In the two days (day -1 and day 0) of both phases, peripheral blood samples will be taken and
      the defined parameters, indicative of blood iron levels, will be measured.

      The primary endpoint is the AUC0-t, Tmax and Cmax of serum iron. The secondary endpoints are
      the standard parameters indicative of blood iron levels.
    

Intervention name(s): IBSA Iron ODF; SiderAL® FORTE
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): IBSA Iron ODF is a food supplement based on ferric pyrophosphate and folic acid in orodispersible film. IBSA Iron ODF appears as a yellow, opaque, homogeneous film, without visible particles. Once taken, it dissolves on the tongue and can be swallowed without adding water.; Sideral® r.m. contained in SiderAL® FORTE is an iron protected with Sucrosomial® Technology which passes through the gastric environment intact and is absorbed in the intestine, thus preventing any irritation and discomfort to the stomach. The presence of Vitamin C facilitates the absorption of iron.
Other intervention name(s): Sucrosomial iron
Intervention MeSH terms: Iron
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-dose, open-label, randomized, double-arm cross-over study
Masking: None (Open Label)
Primary purpose: Other
Oral Contraceptive Efficacy and Body Weight
Condition: Contraception; Body Weight
MeSH terms: Body Weight
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the blood spot validation portion of the study is to test if measuring female
      hormone levels in the blood is as accurate through a finger stick, as it is by a blood draw
      from a vein. The purpose of the feasibility study is to evaluate ovulation occurrence in two
      populations of oral contraceptive users: heavier and lighter women.
    

Detailed description: 
      The blood spot validation portion of the study tests the hypothesis that progesterone assays
      from self-collected daily blood spots are equivalent to serum samples, and that the values
      obtained can identify women that ovulate. After validating collection methods, enrollment
      will begin for the feasibility portion of the study looking at thin and heavy women on birth
      control pills. All women in this portion of the study will take a very-low dose birth control
      pill that is normally available through a doctor's office. During each month of the study,
      women will have their blood pressure and weight recorded, and have their blood drawn twice
      per week or use a finger stick kit daily at home to check for the natural hormones and brain
      chemicals that tells if an egg develops. During the last week of each menstrual cycle (period
      week), women will also have their blood drawn to measure the levels of hormone found in the
      birth control pill. Women will also need to report in a written diary that they have taken
      their birth control pill for the day.
    

Intervention name(s): ethinyl estradiol / levonorgestrel; ethinyl estradiol / levonorgestrel
Intervention type(s): Drug; Drug
Intervention description(s): Take one tablet daily of 20 mcg ethinyl estradiol/100 mcg levonorgestrel for 21 days plus 7 days of placebo tablets, repeat for two months total duration.; Take one tablet daily of 20 mcg ethinyl estradiol/100 mcg levonorgestrel for 21 days plus 7 days of placebo tablets, repeat for two months total duration.
Other intervention name(s): Alesse; Alesse
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Levonorgestrel; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination; Estradiol; Polyestradiol phosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: contraceptive; efficacy; body weight
Comparison of Glargine and Oral Antidiabetic Drugs (OADs) in Newly Diagnosed Type 2 Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The investigators designed this prospective, randomized control study to compare the efficacy
      and safety between the basal insulin glargine therapy and metformin-based OADs after
      correction of the glucose toxicity with a short period of intensive insulin therapy.
    

Detailed description: 
      Detailed Description:

      OBJECTIVE-Type 2 diabetes is associated with defects in insulin secretion and insulin
      sensitivity. Hyperglycemia may aggravate these defects, a feature known as glucose toxicity.
      Previous studies have shown that acute correction of hyperglycemia in subjects with
      long-standing type 2 diabetes gives only short-term improvement in glycemic control after
      discontinuation of insulin. The current study attempts to identify whether basal insulin
      glargine or metformin-based OADs for further management would have a long-term benefit in
      newly diagnosed type 2 diabetes after short-term intensive insulin therapy.

      RESEARCH DESIGN AND METHODS-Newly diagnosed type 2 diabetic patients (fasting blood glucose
      >200 mg/dL or random blood glucose >300 mg/dL) will be hospitalized and treated with
      intensive insulin injection for 10 to 14 days. HbA1c were measured before intensive insulin
      injection. After discharge, patients will be randomized to receive basal insulin injection or
      metformin-based OADs for further management. Patients will be followed in our clinics and
      adjust their medication according to their blood glucose levels. HbA1c were measured 6 months
      later.After the six-month intervention, these patients were continually followed up for
      another six months. Subjects received an oral glucose tolerance test (OGTT) after the
      intensive insulin therapy and at the end of the 6th and 12th month.

      EXPECTED RESULTS-We will expect that basal insulin glargine,compared with metformin-based OAD
      treatment,could more effectively maintain adequate glycemic control in newly diagnosed type 2
      diabetes after short-term intensive insulin therapy.
    

Intervention name(s): metformin-based Oral Antidiabetic Drugs; Glargine
Intervention type(s): Drug; Drug
Other intervention name(s): Metformin and so on; Lantus
Intervention MeSH terms: Metformin; Hypoglycemic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment