bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Estradiol and Progesterone Microspheres for the Treatment of Climacteric Symptoms.
Condition: Menopause
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      During menopause a woman's body slowly produces less of the hormones estrogen and
      progesterone. Lower hormone levels in menopause may lead to hot flashes, vaginal dryness and
      osteoporosis. To help with these problems, women are often given estrogen or estrogen with
      progestin. The purpose of this study is to assess and compare the efficacy and safety of
      three doses of estradiol and progesterone for the treatment of the climacteric symptoms
    

Detailed description: 
      Different formulations of estrogens and progestins have been used for the treatment of
      climacteric symptoms, however up to this date no formulation is completely satisfactory. Our
      company has developed a new technology for the preparation of controlled release bioerodible
      non-polymeric microspheres, these microspheres are capable of delivering doses of estradiol
      (E) and progesterone (P) at levels appropriate for the Hormonal Replacement Therapy (HRT) in
      order to relieve the climacteric symptoms. Non clinical and clinical studies have been
      conducted aimed at assessing the pharmacokinetics of these microspheres, at several doses of
      progesterone and estradiol. Results show that sustained plasma profiles for both steroids
      within the therapeutic range for several days are attained. On this basis, a new efficacy and
      safety study is going to be conducted with the purpose of assessing and defining the most
      appropriate doses of estradiol and progesterone for the HRT of the climacteric symptoms.

      Three different doses of progesterone and estradiol (0.5 mg of E + 15 mg of P vs 1 mg of E +
      20 mg of P vs 1 mg of E + 30 mg of P) will be compared in terms of their efficacy and safety
      to treat the climacteric symptoms in healthy postmenopausal women.
    

Intervention name(s): Estradiol and Progesterone; Estradiol and Progesterone
Intervention type(s): Drug; Drug
Intervention description(s): Injectable suspension of three different dosages of estradiol and progesterone a) 0.5 mg E/15 mg P; b) 1 mg E/20 mg P; c) 1 mg E/30 mg P. Administered on a monthly basis during a six-month period.; Injectable suspension of three different formulations of estradiol and progesterone a) 0.5 mg E/15 mg P; b) 1 mg E/20 mg P; c) 1 mg E/30 mg P. Each will be applied on a monthly basis during a six-month period
Other intervention name(s): estrogens and progestines; Estrogens; Progestins
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate; Estrogens; Progesterone; Progestins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Menopause; Hormone Replacement Therapy; Microspheres; Progesterone; Estradiol; Hot flashes
Identification of Serum Biomarkers for CD15+ Hypodense Neutrophils in Severe Asthma
Condition: Severe Persistent Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The goal of this study is to identify a serum biomarker(s) that can detect increased levels
      of a population of CD15+ hypodense neutrophils termed low-density granulocytes (LDG) in the
      blood of patients with severe persistent asthma.
    

Detailed description: 
      Neutrophils are implicated in the pathophysiology of multiple asthma phenotypes. It was shown
      in study IST Q4935s that low-density granulocytes (LDG) are elevated in the blood of patients
      with moderate or severe asthma. The greatest frequency and the highest percentages of LDG
      were observed in subjects with severe asthma. The LDG, which were first identified and
      characterized in systemic lupus erythematosus (SLE) patients, have been reported to display
      increased cytotoxicity for endothelial cells, increased tendency to form neutrophil
      extracellular traps, and increased production of tumor necrosis factor (TNF). It was also
      observed that the LDG expressed increased levels of CD15, which can facilitate attachment of
      activated platelets to the LDG. Identification of a putative serum biomarker that correlates
      with increased levels of the CD15+ LDG may be useful for the detection of
      neutrophil-associated inflammation in severe asthma.

      Thirty subjects will be screened to identify 20 subjects with severe persistent asthma. The
      following data and/or samples will then be obtained within three weeks of the clinical
      assessment: (1) the percentages of LDG will be quantified by flow cytometry; (2) a blood
      sample will be collected into a PAXgene Blood tube and stored until shipped to Genentech for
      gene profiling analysis; and (3) a serum sample will be collected for measurement of total
      immunoglobulin E (IgE) and for future confirmation of potential biomarkers identified in the
      gene profiling analyses.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Thirty prospective subjects will be screened to identify 20 subjects with severe persistent
        asthma. These subjects will be recruited from the Allergy/Immunology outpatient clinic at
        Rush University Medical Center along with self-referral through advertising posted on
        campus.
      
Biospecimen description: 
      Venous blood and serum will be drawn and shipped to Genentech for analysis.
    
Keywords: Asthma
Efficacy and Safety of Oltipraz in the Patients With Non-alcoholic Fatty Liver Disease
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Dithiolethiones, a novel class of adenosine monophosphate-activated protein kinase (AMPK)
      activators, prevent insulin resistance through AMPK-dependent p70 ribosomal S6 kinase-1
      (S6K1) inhibition. And it is well known that the modulation of S6K1 by oltipraz inhibited the
      development of insulin resistance and hyperglycemia through the AMPK-S6K1 pathway.Also some
      research reported that LXRg (a member of the nuclear hormone receptor)-mediated increases in
      SREBP-1c (the sterol regulatory element-binding protein-1c gene) promote the expression of
      lipogenic genes and enhance fatty acid synthesis and oltipraz inhibits LXRg and SREBP-c.
      Therefore, Oltipraz inhibits fatty acid synthesis through AMPK-S6K1 pathway and LXRg-SREBP-1c
      pathway in liver.
    


Intervention name(s): Placebo; Oltipraz
Intervention type(s): Drug; Drug
Intervention description(s): 30mig/bid or 60mg/bid P.O; 30mig/bid or 60mg/bid P.O
Intervention MeSH terms: Oltipraz
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Psychological Prevention of Internalizing Disorders
Condition: Anxiety Symptoms; Depressive Symptoms; Somatoform Symptoms
MeSH terms: Depression
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether cognitive-behavioral group prevention
      (CBT-G) for german children is effective and to what extent parental group training moderates
      outcome.
    

Detailed description: 
      Internalizing disorders represent a large group of psychological disorders among children who
      are referred to psychological treatment. Anxiety, Depression and somatoform disorders in
      children and adolescents increase the risk of mental disorders in adulthood. Some english
      programs have proved the efficacy of CBT-G prevention.This study will test the efficacy of
      CBT-G in German children. The role of parental involvement is currently subject to scientific
      discussions. The impact of an additional parent-group training will be investigated.
    

Intervention name(s): Cognitive Behavioral Group Therapy; Cognitive Behavioral Group Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12 children group sessions, 8 parent group sessions; 12 children group sessions
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Ambulation Study in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This is a study comparing clinical tests of walking and balance. The goal of this study is to
      discover which of those tests are best at predicting walking problems due to MS.
    

Detailed description: 
      This study includes:

      Three study visits to the MS Center at Evergreen; wearing a pedometer for two, one-week
      periods to record walking during regular daily activities; keeping a diary for any walking
      problems such as falls and slips.

      Subjects must meet the following criteria:

      Diagnosis of MS (any form); 18-70 years of age; be on stable MS treatment OR no MS treatment
      for the last three months; no scheduled hospitalization in the next six months.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects with Multiple Sclerosis
      
Keywords: Mulitple Sclerosis; Ambulation
Comparison of Bed up Head Elevated Intubation Position With Glidescope Assisted Tracheal Intubation
Condition: Bed up Head Elevated Intubation Position
Study type: Interventional

Summary: 
      Positioning during the process of tracheal intubation is critical, as optimal positioning can
      greatly facilitate successful intubation. Many complications can occur as a result of failed
      intubation, ranging from airway injury, lack of oxygen, with even deaths. Today, the most
      popular positioning of patients for intubation is in the "sniffing" position. There is
      however evidence to support that intubation in the bed-up-head-elevated position may be
      better. In today's technological age, video assisted laryngoscopy (Laryngoscopy is the
      process of visualizing the vocal cords prior to intubation), a new method where the
      anaesthetist intubates a patient via aid of an image guided view of the airway, is
      increasingly popular due to its reliability and superiority to normal intubation. However, it
      is not widely available, and may suffer from technical breakdowns. The Glidescope is one
      example of a video laryngoscope, and has been widely researched in the medical literature. In
      this study, the investigators wish to investigate whether intubation in the
      bed-up-head-elevated position will be as good as, if not better than Glidescope assisted
      tracheal intubation, in patients undergoing elective surgery and planned for general
      anaesthesia.
    


Intervention name(s): Tracheal intubation; Glidescope assisted tracheal intubation; Bed up head elevated tracheal intubation
Intervention type(s): Procedure; Device; Device
Intervention description(s): Intubation of the trachea with endotracheal tube; With the use of the Glidescope video laryngoscope, the trachea will be intubated with the endotracheal tube; Use of the Macintosh laryngoscope blade size 3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Bed up head elevated position; Glidescope assisted tracheal intubation; Laryngeal exposure; Time to intubation
POMx In the Treatment of Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      POMx can be used as a treatment for erectile dysfunction.
    


Intervention name(s): Placebo; One POMx capsule daily; 2 POMx Capsules
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 placebo capsules daily; One POMx capsule, one placebo capsule daily; 2 POMx Capsules daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ED; POMx; Pomegranate; Erectile dysfunction
Intravenous Fluids Versus Naso/Orogastric-tube Feeding in Hospitalized Infants With Bronchiolitis
Condition: Viral Bronchiolitis
MeSH terms: Bronchiolitis; Bronchiolitis, Viral
Study type: Interventional

Summary: 
      Oro- or nasogastric tube feeding is safe and may be more physiologic than intravenous (IV)
      fluids in hospitalized infants with acute viral bronchiolitis.
    


Intervention name(s): IV fluids; Naso/oro gastric tube feedings
Intervention type(s): Procedure; Procedure
Intervention description(s): Infants will be allocated to IV fluids; Infants will be allocated to naso/oro gastric tube feedings
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Feasibility Study of the Effect of Intra-Dermal Insulin Injection on Blood Glucose Levels After Eating
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to determine the effect of intra-dermal (ID) administration of regular and of
      rapid-acting insulin, before eating, on blood glucose levels for several hours after a
      standard meal (a mixed, liquid meal). Insulin will also be given normally, subcutaneously,
      for control or comparison purposes. The hypothesis or expectation is that ID insulin will
      work more quickly and control blood glucose levels better than SC injection.
    

Detailed description: 
      Previous studies have shown that intra-dermal (ID) insulin administration results in a more
      rapid onset of action in comparison to subcutaneous (SC) administration as measured by
      glucose infusion rate (GIR) under glucose clamp conditions.The aim of this study is to
      investigate whether ID administration of regular human insulin or rapid-acting insulin
      analogue leads to reduced postprandial glycemic excursions in comparison to SC application
      under highly standardized experimental conditions. Effects on the occurrence of hypoglycemia
      will also be investigated, as well as pK and pD comparisons between different insulin
      formulations administered ID. This is a mono-center, open-label, randomized, 5-period
      crossover study in patients with type 1 diabetes
    

Intervention name(s): Regular insulin (Humulin); Insulin lispro (Humalog)
Intervention type(s): Drug; Drug
Intervention description(s): Insulin will be given either subcutaneously or intra-dermally, and at two different times prior to the liquid meal (T zero). At -17 mins, regular insulin will be given either SC or ID. At -2 mins, regular insulin will be given ID; also insulin lispro will be given either SC or ID. Each patient will receive 1 injection on 5 different study days.; Insulin will be given either subcutaneously or intra-dermally, and at two different times prior to the liquid meal (T zero). At -17 mins, regular insulin will be given either SC or ID. At -2 mins, regular insulin will be given ID; also insulin lispro will be given either SC or ID. Each patient will receive 1 injection on 5 different study days.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; insulin; subcutaneous; intra-dermal; blood glucose
The Influence of Different Food Componente on Zinc Absorption in Young Adults Consuming Zinc Fortified Porridges Prepared From Maize, Beans and Sorghum: a Series of Six Similar Randomized, Single-blind Studies
Condition: Study Not Related to a Disease. Nutrition Study Without Drug Administration.
Study type: Observational

Summary: 
      The influence of different food componente on zinc absorption in young adults consuming zinc
      fortified porridge's prepared from maize, beans and sorghum: a series of six similar
      randomized, single-blind studies.
    


Sampling method: Probability Sample
Study population: 
        Study not related to a disease. Nutrition study without drug drug administration.
        Investigation on the influence of different food components on zinc absorption in young
        adults consuming zinc fortified porridges prepared from maize, beans and sorghum.
The Effect of Surgical Interventions to Assist Orthodontic Movement of Impacted Maxillary Canines
Condition: Impaction of Tooth
MeSH terms: Tooth, Impacted
Study type: Interventional

Summary: 
      Impacted canine causes many problems for patients, such as absorption and damages to the
      adjacent teeth roots, as well as aesthetic problems. Correction of this problem requires a
      lengthy time. Therefore, many methods have been suggested to accelerate the movement of
      impacted canines with the help of surgical procedures.
    


Intervention name(s): Corticotomy; Traditional withdrawal techniques
Intervention type(s): Procedure; Procedure
Intervention description(s): Perforations in the areas close to the impacted canines will be performed in order to accelerate tooth movement.; The impacted canines will be withdrawn using elastic modules.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Seroquel Switching Study: Feasibility of Switching Any Antipsychotic Treatment to Seroquel in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to document the clinical benefit of quetiapine (Seroquel)
      sustained release (SR) after switching from another ongoing antipsychotic treatment,
      regardless of the reason for the switch.

      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation
      was changed to XR after consultation with FDA.
    


Intervention name(s): Seroquel SR
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia
Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy
Condition: Cholelithiasis
MeSH terms: Cholelithiasis; Cholecystolithiasis; Gallstones
Study type: Interventional

Summary: 
      The purpose of this study is to determine the advantages of single trocar cholecystectomy
      over standard laparoscopic cholecystectomy.
    


Intervention name(s): Single trocar cholecystectomy; Standard laparoscopic cholecystectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients with symptomatic cholelithiasis will be operated using the single trocar surgery approach; Patients with symptomatic cholelithiasis will undergo a standard laparoscopic cholecystectomy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cholelithiasis; cholecystitis
Repetitive Transcranial Magnetic Stimulation With Double Cone Coil in Chronic Tinnitus
Condition: Chronic Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      Transcranial Magnetic Stimulation is used to modulate both the auditory neural pathways
      contributing to the perception of phantom sounds, and the regulatory neural network
      responsible for the generation of the individual amount of suffering caused by chronic
      tinnitus.
    

Detailed description: 
      Tinnitus is the phantom auditory perception of sound in the absence of an external or
      internal acoustic stimulus. It is a frequent problem which can interfere significantly with
      the ability to lead a normal life. Treatment remains difficult. Most available therapies
      focus on habituation rather than treating the cause. Tinnitus has been shown to be generated
      in the brain, as a result of functional reorganization of auditory neural pathways and
      tonotopic maps in the central auditory system. Low-frequency rTMS applied to the
      temporoparietal areas has been investigated for the treatment of hyperexcitability disorders
      such as auditory hallucinations and tinnitus. Pilot data indicate that taking into account
      affective components of the multiple overlapping neural networks responsible for the
      generation of a bothersome subjective tinnitus might enhance the efficacy of Repetitive
      Transcranial Magnetic Stimulation (rTMS) treatment in chronic tinnitus. A newly developed
      coil, the so-called double cone coil will be examined with regard to feasibility, safety and
      clinical efficacy in patients suffering from chronic tinnitus in a controlled pilot trial.
    

Intervention name(s): Medial Frontal rTMS Double-Cone-Coil; Left DLPFC Butterfly Coil
Intervention type(s): Device; Device
Intervention description(s): High frequency rTMS ( Alpine Biomed Mag Pro Option) applied over medial superior frontal cortex (supplementary motor cortex) (Brodman area 6/8),Double-Cone-water-cooled-Coil (2000 Stimuli of 10 Hz each session), 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold.; High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 20 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rTMS; repetitive transcranial magnetic stimulation; chronic tinnitus; subjective tinnitus; double cone coil