bioihbjkbjnl/mcl2 huggingface dataset:
Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II
Condition: Cervical Intraepithelial Neoplasia
MeSH terms: Neoplasms; Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators want to test whether treatment with a natural progesterone intravaginally
      increases the cure rate of cervical intraepithelial neoplasia grade I and II.
    

Detailed description: 
      Background:

        1. The development of cervical intraepithelial neoplasia (CIN) was linked to a decreased
           local immune response as evidenced by a decrease of Langerhans' cell (LC) count in the
           cervical epithelium. Preliminary studies show that vaginally administered progesterone
           locally increases the number of LCs.

        2. There is no accepted treatment strategy of low grade CIN, i.e., CIN I and II, than await
           spontaneous regression.

      Thus, vaginal progesterone is expected to increase the regression rate of cervical dysplasia
      grade I and II.

      Outcome parameters:

      Primary outcome parameters:

      To evaluate whether or not a treatment with vaginal progesterone increases regression and
      remission rates of CIN I and II during a 6-month treatment period.

      Secondary outcome parameters:

      Change of immunohistochemically detected expression of LCs in CIN.

      Methods:

      Prospective phase II trial with vaginal progesterone as treatment of CIN I and II. 60
      patients receive vaginal micronized progesterone 400mg 1x daily for 10 days/month from
      menstrual cycle day 16-25 for 6 months. After 3 and 6 months patients are examined for
      possible regression, persistence, or progression of disease and treated accordingly.
      Treatment of patients with progressing CIN is being discontinued after 3 months. Follow-up of
      patients is ensured based on current clinical practice, i.e., regular outpatient visits every
      3 months, until the lesion completely regresses.

      Diagnosis and main inclusion criteria:

      CIN I and II diagnosed by punch biopsy, lesion fully visible, otherwise healthy subjects < 60
      years, no history of breast cancer, patient's compliance

      Medication:

      Micronized progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25

      Duration of treatment:

      6 months
    

Intervention name(s): progesterone
Intervention type(s): Drug
Intervention description(s): Micronized progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25
Intervention MeSH terms: Progesterone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cervical intraepithelial neoplasia (CIN); progesterone
Exploratory Trial of TAS-303 in Female Patients With Stress Urinary Incontinence
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of TAS-303 in female
      patients with stress urinary incontinence.
    

Detailed description: 
      The main purpose of this study is to assess the efficacy of TAS-303 for 8 weeks in female
      patients with stress urinary incontinence (SUI) compared with placebo as measured by the
      percent change in incontinence episode frequency (IEF) from baseline.
    

Intervention name(s): TAS-303; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration for 8 weeks, once daily.; Oral administration for 8 weeks, once daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Urinary Incontinence; Urinary Incontinence, Stress; Lower Urinary Tract Symptoms
Phase II AZD9291 Open Label Study in NSCLC After Previous EGFR TKI Therapy in EGFR and T790M Mutation Positive Tumours
Condition: Non Small Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of AZD9291 in
      Patients with Locally Advanced/Metastatic Non Small Cell Lung Cancer whose Disease has
      Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy
      and whose Tumours are Epidermal Growth Factor Receptor Mutation and T790M Mutation Positive
    

Detailed description: 
      This is a phase II, open label, single arm study assessing the safety and efficacy of AZD9291
      (80 mg, orally, once daily) in patients with a confirmed diagnosis of Epidermal Growth Factor
      Receptor mutation positive and T790M mutation positive NSCLC,who have progressed following
      prior therapy with an approved Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor
      (EGFR-TKI) agent. Patients must agree to provide a biopsy for central confirmation of T790M
      mutation status following confirmed disease progression on the most recent treatment regimen.
      The primary objective of the study is to assess the efficacy of AZD9291 by assessment of
      Objective Response Rate according to RECIST 1.1 by an Independent Central Review.
    

Intervention name(s): AZD9291
Intervention type(s): Drug
Intervention description(s): Once daily tablet 80 mg
Intervention MeSH terms: Osimertinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phase II, open label study; safety and efficacy of AZD9291; diagnosis of Epidermal Growth Factor Receptor mutation positive and T790M mutation positive NSCLC
Pharmacokinetic Study in Healthy Volunteers to Characterise the Exposure of Fluticasone Furoate (FF), Vilanterol (VI) and Umeclidinium (UMEC) at Two Different Doses
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the pharmacokinetics of FF, UMEC and VI administered from one
      inhaler (at two different strengths of UMEC (125 and 62.5microgram [mcg]) and FF/VI
      (ICS/LABA) and UMEC/VI (LAMA/LABA).

      Subjects will receive each of the four treatments once, separated by a wash-out period of
      7-21 days between doses in a four way crossover design. There will be 4 treatment periods in
      total. During each treatment period, subjects will attend the clinical unit on Day -1 for
      standard safety assessments in addition to familiarization with the inhaler. Each subject
      will remain resident in the unit until at least 24 hours after the dose given on Day 1.
      Following completion of all four treatment periods, a follow up visit will take place 7 to 21
      days following the final dose of study medication.
    


Intervention name(s): FF 400 mcg; UMEC 500 mcg; UMEC 250 mcg; VI 100 mcg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 100 mcg powder for inhalation delivered by Dry Powder Inhaler (DPI); 125 mcg powder for inhalation delivered by DPI; 62.5 mcg powder for inhalation delivered by DPI; 25 mcg powder for inhalation delivered by DPI
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GW642444 (Vilanterol); GSK573719 (Umeclidinium); GW685698 (Fluticasone Furoate); pharmacokinetics; Healthy subjects
A Study of Tirzepatide (LY3298176) in Healthy Participants and Participants With Type 2 Diabetes (T2DM)
Condition: Healthy; Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purposes of this study are to determine:

        -  The safety of tirzepatide and any side effects that might be associated with it.

        -  How much tirzepatide gets into the bloodstream and how long it takes the body to get rid
           of it.

        -  How tirzepatide affects the levels of blood sugar.

      This study includes 3 parts (A, B and C). Part A involves a single dose of tirzepatide taken
      as a subcutaneous (SC) injection just under the skin and will be approximately 10 weeks in
      duration, including screening. Parts B and C involve 4 doses of tirzepatide taken once weekly
      (over 4 weeks) as a SC injection just under the skin and is approximately 12-14 weeks in
      duration, including screening. Each participant will enroll in only one part.

      This study is for research purposes only, and is not intended to treat any medical condition.
    


Intervention name(s): Tirzepatide; Placebo; Dulaglutide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered SC; Administered SC; Administered SC
Other intervention name(s): LY3298176; Trulicity®
Intervention MeSH terms: Dulaglutide; Tirzepatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study of Allogeneic Bone Marrow Transplantation Following Cyclophosphamide and Radiotherapy in Patients With Fanconi's Anemia
Condition: Fanconi's Anemia
MeSH terms: Fanconi Syndrome; Anemia; Fanconi Anemia
Study type: Interventional

Summary: 
      OBJECTIVES:

      I. Determine the effectiveness of moderate dose cyclophosphamide and total lymphoid
      radiotherapy in terms of improving the survival and reducing the morbidity following
      allogeneic bone marrow transplantation in patients with Fanconi's aplastic anemia.
    

Detailed description: 
      PROTOCOL OUTLINE: Patients receive cyclophosphamide IV over 2 hours on day -6 through -3 and
      total lymphoid radiotherapy on day -1. Patients undergo allogeneic bone marrow
      transplantation on day 0.

      Patients are followed for at least 100 days.
    

Intervention name(s): cyclophosphamide; Allogeneic Bone Marrow Transplantation
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Cyclophosphamide
Primary purpose: Treatment
Keywords: Fanconi's Anemia; aplastic anemia; hematologic disorders; rare disease
Phase 1 Safety, Tolerability and PK Study of Ondansetron and Hylenex Recombinant in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open-label Phase 1 pharmacokinetic, tolerability, and safety study of
      ondansetron and Hylenex given subcutaneously compared to ondansetron given intravenously,
      intramuscularly, and orally in normal healthy volunteers.
    

Detailed description: 
      This is a randomized, open label, 4 way crossover Phase 1 study of the pharmacokinetics,
      safety and tolerability of a 4 mg dose of ondansetron administered subcutaneously with
      Hylenex recombinant compared to 4 mg doses of ondansetron administered intravenously and
      intramuscularly and an 8 mg dose of ondansetron administered orally.
    

Intervention name(s): Ondansetron; Ondansetron + Hylenex; Zofran ODT; Ondansetron solution
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ondansetron solution 4 mg single administration; Ondansetron solution (4 mg) single administration + Hylenex recombinant (150 U) single administration; Zofran ODT (8 mg) single administration; Ondansetron solution (4 mg) single administration
Other intervention name(s): Zofran; Zofran; ondansetron disintegrating tablet - oral; Zofran
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Safety; Healthy Volunteers; tolerability
Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Study of L-Dopa/Carbidopa To Treat Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Determine if a novel levodopa/carbidopa formulation results in a better clinical response on
      Parkinson's Disease patients compared to the reference formulation of levodopa/carbidopa in
      terms of motor complications, onset of action and response duration.
    

Detailed description: 
      Primary objective is to demonstrate a better clinical response profile of novel
      levodopa/carbidopa formulation vs. the reference formulation of levodopa/carbidopa in
      patients with Parkinson's Disease as judged by motor performance and to describe
      pharmacokinetic profile for the novel formulation compared to the reference.
    

Intervention name(s): levodopa-carbidopa
Intervention type(s): Drug
Intervention description(s): novel levodopa/carbidopa formulation or a reference levodopa/carbidopa formulation
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Treatment of Parkinson's Disease
Tissue Characterization in Teeth Treated With a Regeneration Protocol
Condition: Pulp Necrosis
MeSH terms: Dental Pulp Necrosis; Necrosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of the investigators study is to characterize the composition of the hard and
      soft tissues present in root canals of teeth previously diagnosed with necrotic pulps and
      incomplete root formation and treated with a triple antibiotic regeneration protocol. The
      investigators hypothesis is that treatment of teeth with necrotic pulps and immature apices
      with triple antibiotic paste will stimulate continued root formation by the deposition of
      dentin at the root apices. The primary outcome measure will be histological identification of
      mineralized tissue and adherent cells in the apical third of these teeth.
    

Detailed description: 
      'Regeneration' as referred to in this protocol refers to the stimulation of continued root
      formation by the deposition of apical tissues subsequent to disinfection of a necrotic root
      canal and its contents and creation of a scaffold upon which cells can proliferate. While the
      proposed treatment protocol is currently being used in clinical practice and has been shown
      to be successful in case reports and case series, the nature of the proliferating apical
      tissues remains unknown. Thus, this study is uniquely positioned to address a critical gap in
      knowledge in the regeneration of a functional pulp-dentin complex. Moreover, results obtained
      from pediatric cases may well provide the essential foundation of knowledge for endodontists
      to apply this knowledge to the more difficult situation of regenerating the pulp-dentin
      complex of the full mature permanent tooth.
    

Intervention name(s): Triple Antibiotic Paste; Triple Antibiotic Paste; Triple Antibiotic Paste
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ciprofloxacin, metronidazole & minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection and cell proliferation.; ciprofloxacin, metronidazole & minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection and cell proliferation.; ciprofloxacin, metronidazole & minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection and cell proliferation.
Intervention MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Regeneration (revascularization) of dental pulp; Immature Permanent Tooth With a Diagnosis of Pulpal Necrosis
Comparison of Erector Spinae Plane Block and Rectus Sheath Block
Condition: Postoperative Pain, Acute
MeSH terms: Pain, Postoperative; Acute Pain
Study type: Interventional

Summary: 
      In study, The investigators aimed to compare the intraoperative and postoperative analgesic
      efficacy of erector spinae plane block and rectus sheath block, which investigators routinely
      perform in surgeries with abdominal lover midline-upper midline incision, morphine
      consumption with patient-controlled analgesia, as well as patient and surgeon satisfaction.
    

Detailed description: 
      Following ethics committee approval and written consent from the patients, the study was
      conducted on 60 patients aged between 18-75 years in American Society of Anesthesiologists
      (ASA) classes I-III, who were to undergo midline incisions. The demographic data of the
      patients were recorded and after routine monitoring and general anesthesia induction, they
      were divided into two groups as the ESPB group and RSB group. Hemodynamic data of all
      patients were recorded before induction, one minute after induction, and intraoperatively in
      30-minute periods. Patient-controlled analgesia (PCA) prepared with morphine was administered
      to all patients. Patients' intraoperative hemodynamic data and administered opioid doses,
      postoperative visual analog scales (VAS) at rest and during coughing, time to first PCA dose,
      postoperative morphine consumption, need for rescue analgesics, duration time until first
      mobilization, opioid side effects, and patient and surgeon satisfaction were evaluated.
    

Intervention name(s): bupivacaine
Intervention type(s): Other
Intervention description(s): used for peripheral block
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: erector spinae plane block; rectus sheath block; pain management; midline laparotomy
Comparison of High Flow Oxygenation Therapy and CPAP in Children With Bronchiolitis.
Condition: Respiratory Syncytial Virus Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional

Summary: 
      Bronchiolitis in infants and young children often requires respiraty support. In Denmark
      Continous Positive Airway Pressure ( CPAP) are routinely used in children with
      moderate-severe bronchiolitis. The aim of the study is to compare CPAP and High Flow
      Oxygenation Therapy (HFOT) as tools of respiratory support in infants and young children with
      bronchiolitis.

      Infants and young children with moderate-severe bronchiolitis and are randomized to either
      CPAP or HFOT.
    


Intervention name(s): Optiflow Junior; Continous Positive Airway Pressure
Intervention type(s): Device; Device
Intervention description(s): Humified air are dispensed through the system. Airflow, FiO2 (Fraction of inspired oxygen) , SpO2 (peripheral capillary Oxygen saturation) and respiratory rate are noted each hour. Progression of condition might lead to change of system og mechanical ventilation. poor tolerance might lead to change of system; Humified air are dispensed throug the system. Airflow, FiO2, SpO2 and respiratory rate are noted each hour. Progression of condition might lead to change of system or mechanical ventilation. Poor tolerance might lead to change of system.
Other intervention name(s): High Flow Oxygenation Therapy; HFOT; CPAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Continuous Positive Airway Pressure; High Flow Oxygenation therapy; Bronchiolitis; Children
Reliability of Hand Held Dynamometer for Assessing Isometric Lumbar Muscle Strength in Asymptomatic Healthy Population
Condition: Healthy
Study type: Interventional

Summary: 
      To determine intra-rater and inter-rater reliability of hand held dynamometer for assessing
      isometric lumbar
    

Detailed description: 
      After being informed about the study and potential risks, all participants given informed
      consent underwent a 1-week screening period to determine eligibility for study entry. Two
      raters assessed isometric strength of lumbar flexor and extensor muscles, by a hand-held
      dynamometer. Strength was measured and recorded by each of the two raters and re-assessed
      after a week.
    

Intervention name(s): MicroFET 2
Intervention type(s): Device
Intervention description(s): Lumbar Flexor and Extensor Strength Measurement
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Reliability; Lumbar region; Muscle strength dynamometer
Exploring Deployment Stress and Reintegration in Army National Guard Chaplains
Condition: Combat Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Combat Disorders
Study type: Observational

Summary: 
      The purpose of this 2-year pilot study is to explore the impact of deployment on the
      psychosocial and health characteristics and reintegration of Military Chaplains, specifically
      those of the Army National Guard (ARNG). This pilot will serve as the foundation for
      subsequent investigations of chaplains from multiple branches of the military. In addition to
      spiritual and religious support, Military Chaplains play a key role in the behavioral health
      of deployed service-members, routinely participating in suicide prevention training,
      conducting critical event debriefing, and identifying service-members at risk for combat and
      operational stress reactions1. A high risk group for exposure to trauma2, Military Chaplains
      have suffered brain injuries, gunshot wounds and blast injuries in OEF/OIF Theater3. In
      addition, many report combat related stress issues such as compassion fatigue, PTSD, and
      reintegration issues3. While the traumatic experiences of OEF/OIF deployed troops have been
      well documented, the effects on military chaplains caring for these service-members have
      received little attention in the research to date. We are collaborating with the National
      Guard Chaplain Corps Leadership on this program of research. The aims of this 2-year pilot
      cross-sectional study focus on describing and exploring deployment and its impact on
      psychosocial, health characteristics and reintegration of ARNG chaplains using a mixed method
      approach (web-based survey, in-depth interviews, social network analysis).
    


Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        ARNG Chaplains who have ever/never been deployed to OEF/OIF combat theaters
      
Keywords: war; religion; caregiver; combat stress disorder