bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Tolerability Evaluation of Sintilimab in Combination With Radiation in Stage IV NSCLC Patients
Condition: Stage IV NSCLC
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      This pilot phase I trial aims to investigate the safety and tolerability of anti-programmed
      cell death-1 (PD-1) monoclonal antibody Sintilimab (also called IBI308) in combination with
      concurrent stereotactic body radiation therapy (SBRT) and low dose radiotherapy (LDRT) in
      treating patients with stage IV non-small cell lung cancer (NSCLC).

      At least 29 participants will be enrolled in this study. All will take part at West China
      Hospital, Sichuan University.
    

Detailed description: 
      This exploratory phase I study will be conducted in two steps:

      Step A: A low dose radiotherapy (LDRT) dose escalation, 6 patients per cohort (a total of 18
      patients) will be enrolled to determine the maximum tolerated dose (MTD), dose-limiting
      toxicity (DLT) and recommended dose for expansion (RDE) for lung LDRT.

      Step B: A lung LDRT dose expansion

      All eligible patients will receive lung SBRT dosed at 30 Gy in 3 fractions, in combination
      with LDRT at different dose levels (decried as below) starting from the 2nd day of SBRT,
      followed by sintilimab monotherapy starting within 7 days after radiation completed.
      Sintilimab will be given at 200mg every 3 weeks until disease progression, unacceptable
      toxicities, the patient withdraws informed consent, or sintilimab reaches a maximum of up to
      24 months.

      Patients in the dose escalation will receive lung LDRT at 3 cohorts with increasing dose
      levels: 2 Gy in 1 fraction in dose level 1, 4 Gy in 2 fractions in dose level 2, 10Gy in 5
      fractions in dose level 3.

      A cohort of 17 patients will receive lung LDRT at the RDE determined during the dose
      escalation phase in combination with SBRT and Sintilimab to obtain additional safety and
      response data.
    

Intervention name(s): Sintilimab; stereotactic body radiation therapy; Low Dose Radiotherapy
Intervention type(s): Drug; Radiation; Radiation
Intervention description(s): Patients will receive treatment with Sintilimab 200mg every 3 weeks for a maximum of 24 months.; Radiation treatment utilized in this trial consists of SBRT with a standard doses to 30 Gy/3f; LDRT at dose escalation levels: 2 Gy/1f, 4 Gy/2f, 10 Gy/5f with conventional external beam radiation.
Other intervention name(s): IBI308; SBRT; LDRT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immunotherapy;SBRT; PD-L1 positive; LDRT
Staccato Loxapine in Migraine (in Clinic)
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this trial is to assess the efficacy and safety of Staccato Loxapine in
      patients with migraine headache with or without aura in a clinical setting.
    

Detailed description: 
      This study will enroll male and female patients with migraine headache with or without aura.
      The study will randomize ~160 patients, 1:1:1:1 to receive one of the following treatments:
      1.25 mg Staccato Loxapine; 2.5 mg Staccato Loxapine; 5 mg Staccato Loxapine; Staccato
      Placebo.
    

Intervention name(s): Staccato Loxapine; Staccato Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo aerosol inhalation (0mg)
Other intervention name(s): ADASUVE
Intervention MeSH terms: Loxapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Staccato® Loxapine, Migraine
Circadian Variation in Serum-progesterone Levels Following Controlled Ovarian Hyperstimulation.
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      The aim of the study is to investigate the circadian variation in serum-progesterone in women
      undergoing controlled ovarian stimulation.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women undergoing IVF-treatment using either GnRHa long protocol or GnRH antagoinst
        co-treatment.
      
Biospecimen description: 
      Serum
Bone Mineral Density, Disease Duration, and Activity in Ankylosing Spondylitis
Condition: Ankylosing Spondylitis; Osteoporosis; BMD
MeSH terms: Spondylitis; Osteoporosis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Observational

Summary: 
      Our clinical study aimed to evaluate the prevalence of osteoporosis (OP) in patients with
      ankylosing spondylitis (AS) and to investigate the relationship between clinical, disease
      activity, physical function and disease duration, and bone mineral density (BMD).
    

Detailed description: 
      In this cross-sectional study, patients who were admitted to the rheumatology clinic between
      18 and 65 years of age and diagnosed as AS according to the modified New York diagnostic
      criteria were included

      Patients group was divided two part as patients with (group 1)and without (group 2)
      osteoporosis.

      The patient's global rating scale is a self-assessed scale of the patient with a grade of 10
      (1: very bad, 5: moderate, 10: very good). To assess the disease activity, Bath ankylosing
      spondylitis disease index (BASDAI) and Bath ankylosing spondylitis functional index (BASFI)
      were evaluated. BASDAI is a self-assessment scale used to determine disease activity in
      patients with AS.

      Schober measurement was used to evaluate lumbar mobility of the patients. Chest expansions
      were measured in all patients.

      Body mass index (BMI) was calculated as kg/height m2. Erythrocyte sedimentation rate (ESH mm
      / h), C-reactive protein (CRP mg / l) levels were measured in all patients.

      BMD measurements were made by using dual-energy x-ray absorptiometry (DEXA) and lumbar
      vertebra (L1-4) and left femur (femoral neck and total) regions. DEXA measurements (GE /
      LUNAR DPX PRO) were performed and the results were recorded using standard T score. Bone
      mineral densities of patients were based on the World Health Organization (WHO)
      classification of a T score between -1 and -2.5 for osteopenia; and a score of -2.5 for
      osteoporosis.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        patients who were admitted to the rheumatology clinic between 25 and 65 years of age and
        diagnosed as AS according to the modified New York diagnostic criteria were included
Determining Effectiveness of an mHealth Intervention to Provide Adolescent CBT
Condition: Adolescent Depression; Anxiety Disorders
MeSH terms: Depression; Anxiety Disorders
Study type: Interventional

Summary: 
      Washington University will evaluate the acceptability and effectiveness of a mobile health
      (mHealth) intervention to provide cognitive behavioral therapy for adolescents with
      depression.
    

Detailed description: 
      In this pilot project, Washington University will start to evaluate CBot-A, a promising
      mHealth therapeutic intervention designed to deliver cognitive behavioral therapy (CBT)
      through an app on a phone or other mobile device. The evaluation will include a randomized
      trial among 40 adolescents diagnosed with depression and/or anxiety and will assess if CBot-A
      is usable by teens and likely to provide benefit, and acceptable to adolescents.

      The primary outcome of depression and anxiety symptoms in adolescents will be assessed at 1
      month and 3 months to check for any changes.
    

Intervention name(s): mHealth app
Intervention type(s): Behavioral
Intervention description(s): Participants will receive access to CBot-A app for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Behavioral Therapy; mHealth
The Effectiveness of Simethicone In Improving Visibility During Colonoscopy
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 4

Summary: 
      Sodium phosphate is one of the bowel preparation regimens for colonoscopy. However,
      intraluminal gas can impair visibility during the examination. Simethicone is medication that
      works by reducing the surface tension of air bubbles. We aimed to evaluate the effect of
      simethicone in enhancing visibility and efficacy during colonoscopy.
    

Detailed description: 
      A prospective, randomized, double-blinded, placebo-controlled study was conducted. One
      hundred and twenty-four patients were allocated to receive 2 dosages of either 45 ml of
      sodium phosphate plus 240 mg of simethicone tablets or 45 ml of sodium phosphate plus placebo
      in the evening before and in the morning of the procedure day. The colonoscopic examination
      was recorded. Visibility was blindly assessed for the amount of air bubbles and the degree of
      haziness by a single investigator. Five areas of the colon were graded for the amount of air
      bubbles, from 0 to 3; grade 0 and 1 were defined as the diminishing of air bubbles. The
      haziness was graded into 5 levels from excellent to unacceptable. Excellent, good and
      adequate were defined as the diminishing of haziness. The total duration of colonoscopy, the
      side effect of medication and the endoscopist and patient satisfaction were compared between
      2 groups. Endoscopist satisfaction was evaluated by questionnaires. Visual analog scale
      (0-10) was used for rating patient satisfaction and the side effect of medication.
    

Intervention name(s): Simethicone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 dosages of either 45 ml of sodium phosphate plus 240 mg of simethicone tablets or 45 ml of sodium phosphate plus placebo in the evening before and in the morning of the procedure day. The colonoscopic examination was recorded; 2 dosages of either 45 ml of sodium phosphate plus 240 mg of simethicone tablets or 45 ml of sodium phosphate plus placebo in the evening before and in the morning of the procedure day
Other intervention name(s): sodium phosphate; Sodium phosphate
Intervention MeSH terms: Simethicone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bowel preparation, colonoscopy, simethicone, air bubble
A Study to Evaluate the Bioavailability of Risankizumab Following Subcutaneous Dosing in Healthy Male Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the bioavailability, safety and tolerability of
      risankizumab following subcutaneous injections in healthy male participants.
    


Intervention name(s): risankizumab; risankizumab
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous Injection via prepared syringe; Subcutaneous Injection via syringe pump
Other intervention name(s): ABBV-066; SKYRIZI; ABBV-066; SKYRIZI
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
TiLE (Time Lapse Eeva) Clinical Trial
Condition: Fertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study was to explore the added value of adjunctive use of Early Embryo
      Viability Assessment (Eeva) with morphological grading in identifying optimal embryos for
      transfer.
    

Detailed description: 
      This study is a Phase IV, open label, prospective, randomized, exploratory, multicenter
      study. Subjects were randomized in 2:1 ratio to two treatment groups: in the experimental
      group, embryos were assessed for embryo transfer (ET) with Eeva and morphological grading,
      while in the control group embryos were assessed with morphological grading only.
    

Intervention name(s): Eeva
Intervention type(s): Device
Intervention description(s): Embryos of subjects randomized in this group were assessed using Eeva System and morphological grading to identify optimal embryos for transfer.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: TiLE; Embryo Assessment; Pregnancy; Implantation
A Study to Evaluate the Efficacy, Safety, and Tolerability of SAGE-324 in Participants With Essential Tremor
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2, double-blind, placebo-controlled study to evaluate the safety and efficacy
      of SAGE-324 compared to placebo on upper limb tremor reduction in individuals with essential
      tremor (ET).
    


Intervention name(s): SAGE-324; SAGE-324 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SAGE-324 oral tablet; SAGE-324 matched placebo oral tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Essential Tremor; SAGE-324
Investigation of 2 Different Oral Formulations of Estradiol and Norethisterone in Healthy Women
Condition: Menopause; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate whether a
      reformulated estradiol/norethisterone acetate (NETA) formulation is bioequivalent to that of
      Kliogest® (estradiol/norethisterone acetate (NETA) in healthy women.
    


Intervention name(s): 2 mg estradiol / 1 mg norethisterone acetate (NETA)
Intervention type(s): Drug
Intervention description(s): A single dose of one tablet under fasting conditions separated by a wash-out period of 2 weeks (+0-2 days) between dosing visits. Administered orally.
Intervention MeSH terms: Norethindrone; Norethindrone Acetate; Estradiol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Drug Interaction Study of the Effect of Ketoconazole at Steady State on the Pharmacokinetics of a Single Dose of Isavuconazole in Healthy Adult Subjects
Condition: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Ketoconazole; Healthy Adult Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of ketoconazole at steady state on the
      pharmacokinetics of a single dose of isavuconazole in healthy adult subjects.
    


Intervention name(s): Isavuconazole; Ketoconazole
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): BAL4815; BAL8557
Intervention MeSH terms: Ketoconazole; Isavuconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Isavuconazole; Ketoconazole; Healthy Volunteers; BAL8557; BAL4815
Stachybotrys Induced Hemorrhage in the Developing Lung
Condition: Idiopathic Pulmonary Hemorrhage
MeSH terms: Hemorrhage
Study type: Observational

Summary: 
      The majority of the workscope of this project is focussed on an infant animal model of
      toxigenic mold induced pulmonary hemorrhage. Clinically related studies are directed only to
      the description of human infants diagnosed with idiopathic pulmonary hemorrhage regarding
      their clinical parameters, and collecting samples of secretion, blood, and urine for analysis
      for fungal spores and mycotoxins. These latter analyses are being developed using the infant
      rat model.
    

Detailed description: 
      Over the past seven years in the Cleveland, Ohio area there have been 47 cases of unexplained
      pulmonary hemorrhage in young infants. Sixteen of the infants have died. A CDC case-control
      study found an association with water-damaged homes and the toxigenic fungus, Stachybotrys
      chartarum, which requires water soaked cellulose to grow. The spores of this fungus are not
      infectious in the lung but do contain very potent mycotoxins which appear to be particularly
      toxic to the rapidly developing lungs of young infants. Secondary stresses, e.g.
      environmental tobacco smoke, appear to be important triggers of overt hemorrhage. Concern
      that there may be a larger number of undetected young infants with this disorder led to the
      examination of all infant coroner cases, which revealed six sudden infant death syndrome
      cases with major amounts of pulmonary hemosiderin-laden macrophages, indicating extensive
      hemosiderosis existing prior to death. All of these infants had lived in the eight zip code
      area where all but fifteen of the patients have lived. This disorder may extend beyond
      Cleveland since toxigenic fungi are widespread. We are aware of a total of 138 infants with
      idiopathic pulmonary hemorrhage across the country over the past four years.

      The purpose of this proposal is to establish an infant animal model for this
      stachybotryomycotoxicosis which can be used to understand the developmental pathophysiology
      by which the fungal spores induce hemorrhage and to address practical problems faced in the
      clinical care of these infants and in public health prevention. The model uses tracheal
      instillation of toxic Stachybotrys spores in neonatal to weanling rats to initiate the
      pathological process, followed by stresses to trigger acute hemorrhage. Capillary fragility
      to transmural pressures will be assessed by morphometric analysis of electron micrographs.
      Markers of Stachybotrys exposure which can be applied to clinical cases are being developed
      and tested in the rats.
    

Keywords: idiopathic pulmonary hemorrhage in infants,; toxigenic mold exposure
A Study To Investigate Safety And Pharmacokinetics Of A Single Dose Of PF-00868554 (Filibuvir) In Japanese Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A single dose of PF-00868554 (filibuvir) will be safety and tolerable in Japanese healthy
      volunteers. The pharmacokinetics in Japanese will be consistent to that available in Western
      population.
    

Detailed description: 
      Investigation of safety, tolerability and pharmacokinetics of single oral administration of
      PF-00868554 (filibuvir) in healthy adult Japanese volunteers.
    

Intervention name(s): Active; Placebo; Active; Placebo; Active; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Six subjects will receive PF-00868554 (filibuvir) 100 mg under fasting condition.; Two subjects will receive the placebo under fasting condition.; Six subjects will receive PF-00868554 (filibuvir) 300 mg under fasting condition.; Two subjects will receive the placebo under fasting condition.; Six subjects will receive PF-00868554 (filibuvir) 500 mg under fasting condition.; Two subjects will receive the placebo under fasting condition.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: filibuvir; pharmacokinetics; Japanese; Asian
Effects of Alpha-1 Antagonist, Stress and Relaxation on Anorectal Functions
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to better understand the effects of effects of stress, relaxation, and
      a medication alfuzosin on bowel control and emptying in healthy people and patients with
      bowel problems.
    

Detailed description: 
      Normally, bowel emptying requires relaxation of the anal sphincter (i.e., lowermost end of
      intestinal tract) and pelvic muscles. Some people cannot relax these muscles normally and
      experience constipation. Alfuzosin is a medication which is approved to treat bladder but not
      bowel problems.
    

Intervention name(s): Alfuzosin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): oral alfuzosin immediate release (IR) 2.5 mg (Part A) or oral alfuzosin extended release (ER) 10 mg (Part B); placebo capsule identical to the study drug
Other intervention name(s): Xatral (immediate release 2.5 mg); Uroxatral (extended release 10 mg)
Intervention MeSH terms: Alfuzosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Drug-Drug Interaction to Study the Effect of BMS-708163 on Pharmacokinetics (PK) of Galantamine Extended Release (ER)
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to find out if the plasma concentration of galantamine extended
      release is changed when BMS-708163 is administered at the same time.
    


Intervention name(s): galantamine; galantamine; BMS-708163
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Capsule, Oral, 8 mg (ER), once daily, Days 1-7; Capsule, Oral, 16 mg (ER), once daily, Days 8-24; Capsule, Oral, 125 mg, once daily, Days 15-24
Other intervention name(s): Razadyne ER ™; Razadyne ER ™
Intervention MeSH terms: Galantamine; BMS 708163
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-042)
Condition: Recurrent Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Study the effect of etoricoxib 60 mg and 90 mg compared to placebo to treat chronic low back
      pain.
    


Intervention name(s): MK0663, Etoricoxib / Duration of Treatment : 12 Weeks; Comparator : placebo (unspecified) /Duration of Treatment : 12 Weeks
Intervention type(s): Drug; Drug
Intervention MeSH terms: Etoricoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment