bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics, Safety, and Tolerability of Intramuscular 5-MeO-DMT in Healthy Volunteers
Condition: Pharmacokinetics; Safety; Tolerability
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to assess the pharmacokinetics, safety, and
      tolerability of a single-dose and multiple-doses of 5-MeO-DMT administered by intramuscular
      (IM) injections in healthy subjects.
    

Detailed description: 
      This study is a phase 1, first-in-human, double-blind, placebo-controlled, randomized,
      single-dose and multiple-ascending-dose study of 5-MeO-DMT administered by intramuscular
      injection in 54 healthy subjects (adult male and/or females, 18-65 years of age). Subjects
      will be randomized 6:1 to receive 5-MeO-DMT or placebo.
    

Intervention name(s): 5-methoxy-N,N-dimethyltryptamine succinate salt; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The 5-MeO-DMT drug product is comprised of the appropriate concentration of 5-MeO-DMT succinate salt drug substance in solution with 0.9% sodium chloride injection solution (USP) in a 5 mL glass vial, and is administered intramuscularly.; The placebo is commercially available 0.9% sodium chloride solution (USP) for injection. The placebo is provided by the pharmacy in single-use sterile syringes of the appropriate dose.
Other intervention name(s): 5-MeO-DMT succinate salt; 5-MeO-DMT; 0.9% sodium chloride solution (USP)
Intervention MeSH terms: N,N-Dimethyltryptamine
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This study will include separate single- and multiple-dose parts.
Single-dose part:
A double-blind, placebo-controlled, randomized, sequential-group design with 5-MeO-DMT administered by intramuscular injection in 6 cohorts of 6 subjects (randomized as 5 active and 1 placebo subject(s) per group).
Multiple-dose part:
A double-blind, placebo-controlled, randomized, sequential-group design with 5-MeO-DMT administered by intramuscular injection in up to two doses within a single day (3-hour interval) with two different dose levels (6 subjects per group).
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: 5-MeO-DMT; Psychedelics; Safety; Pharmacokinetics; First-in-human; 5-methoxy-N,N-dimethyltryptamine
SUV Max as Predictor of Outcome in Cervical Cancer
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      Cervical Cancer is staged clinically, not surgically. Patients in whom an extensive disease
      is identified are not usually eligible for surgery. PET-CT is used to support staging.
      However, some patients received surgery after staging and subsequently require
      radio/chemotherapy due to findings on operation.

      This study will attempt to find a correlation between SUV-Max on PET-CT and subsequent
      outcomes i.e. need for adjuvant therapy.
    


Intervention name(s): Radiotherapy
Intervention type(s): Radiation
Intervention description(s): Radiotherapy for cervical cancer
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Females age 18-80, diagnosed with cervical cancer
      
Keywords: Cervical Cancer; PET CT; SUV Max
Pharmacodynamic Open-Label Trial With VXA-A1.1 Oral H1 Vaccine in Healthy Adults
Condition: Seasonal Influenza Preventative Vaccine Pharmacodynamics
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 open-label pharmacodynamics study in healthy adults. The purpose of the
      study is to determine if the tablet formulation size of VXA-A1.1, an adjuvanted adenoviral
      based influenza vaccine, has an impact on delivery location. The secondary objective is to
      evaluate delivery with fasting versus fed status.
    

Detailed description: 
      This is a pharmacodynamics study in healthy adult males. The purpose of the study is to
      determine if the tablet formulation size of VXA-A1.1, an adjuvanted adenoviral based
      influenza vaccine, impacts the location and time of initial and complete disintegration of
      the drug product. The secondary objective is to evaluate delivery with fasting versus fed
      status.
    

Intervention name(s): VXA-A1.1 H1 Tablet Vaccine (small); VXA-A1.1 H1 Tablet Vaccine (large)
Intervention type(s): Biological; Biological
Intervention description(s): Tableted oral H1 vaccine (~140 mg tablet); Tableted oral H1 vaccine (~275 mg tablet)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: open-label with two tablet sizes labeled with different radioisotopes
Masking: None (Open Label)
Primary purpose: Other
Adrenal Function in GHD Children
Condition: Growth Hormone Treatment; Adrenal; Functional Disturbance
Study type: Observational

Summary: 
      To evaluate in children affected by idiopathic GHD the adrenal function both at baseline and
      after 6 and 12 months of GH treatment.
    

Detailed description: 
      The relationship between the growth hormone (GH)-insulin like growth factor (IGF)-I system
      and the hypothalamic-pituitary-adrenal (HPA) axis is complex and not univocal. Both a
      stimulatory and neutral effect of IGF-I on HPA axis has been demonstrated in in vitro models
      and in healthy subjects, respectively. The effect of GH on the 11beta-hydroxysteroid
      dehydrogenases (11beta-HSD) isozymes is always to be considered in patients affected by GHD
      both at diagnosis and during GH treatment. Indeed, in peripheral tissues, corticosteroid
      hormone action is partially determined by the activity of 11beta-HSD, two isozymes of which
      interconvert hormonally active cortisol and inactive cortisone. 11beta-HSD2 inactivates
      cortisol to cortisone in the kidney, whilst 11beta-HSD1 performs the reverse reaction
      activating cortisol from cortisone in the liver and adipose tissue.

      For these reasons, many data are available about the evaluation of adrenal function in
      patients affeceted byGHD, but most of them come from patients with organic GHD or adult
      patients, while few and discordant data are available on pediatric GHD patients. We aimed to
      evaluate, through insulin tolerance test, the adrenal function in about 30 children with
      overt diagnosis of idiopathic GHD both at baseline and after 6 and 12 months of GH treatment.
    

Intervention name(s): growth hormone
Intervention type(s): Drug
Intervention description(s): Children with a diagnosis of GHD will practice GH replacement therapy in line with normal clinical practice and international guidelines. Controls will be evaluated just at baseline.
Intervention MeSH terms: Hormones
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        30 consecutive children with short stature and overt idiopathic GHD and 30 children with
        constitutional short stature without endocrine disease
      
Keywords: growth hormone; children; adrenal function
Cd133+ Cell Infusion in Patients With Colorectal Liver Metastases.
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Treatment of patients with metastatic colorectal carcinoma is surgical resection. Only 10-15%
      of the patients will be candidates for curative resection. After response to chemotherapy
      this figure rises 10-13% more. To perform the surgery it is necessary to have a sufficient
      remnant liver volume (RLV), which allows maintaining optimal liver function after resection.
      If the estimated RLV is insufficient preoperatively, portal venous embolization site (PVE) is
      performed for compensatory hypertrophy, thus increasing the number of resections 19%. Still,
      in 20% of these patients surgery can not be performed because RLV is not achieved or because
      the disease progresses while waiting for growth. Therefore, it is necessary to improve liver
      regeneration without promoting tumor growth. Studies on liver regeneration, have determined
      that cells (CD133 +) are involved in the liver hypertrophy that occurs after hepatectomy.
      CD133 + have been used to induce liver hypertrophy with encouraging results. This population
      of CD133 +, can be selected from peripheral blood after stimulation with Granulocyte
      colony-stimulating factor (G-CSF), being able to obtain a large number of them. The
      investigators propose to treat patients who do not meet criteria for surgery because of
      insufficient volume <40%, with CD133 + and portal embolization in order to carry out a
      surgical resection in a second place.
    


Intervention name(s): CD133+ infusion; portal vein embolization
Intervention type(s): Drug; Other
Intervention description(s): Infusion of cells cd133+; portal vein embolization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Walnut Consumption and Diabetes Risk
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      Multiple NHANES surveys were combined and weighted to evaluate relationships between walnut
      consumption and type 2 diabetes mellitus using various independent measures of diabetes
      status and risk. After risks were ascertained, interactions with gender were analyzed.
    

Detailed description: 
      Background. Dietary interventions and cohort studies of tree nuts lowering glucose levels for
      diabetes suggest a possible effect with walnuts. Objective. To examine the associations
      between walnut consumption and diabetes risk through data from the National Health and
      Nutrition Examination Survey (NHANES). Methods. NHANES survey data for 1999 through 2014 was
      pooled for adults with 24 hour recall dietary data. Risk of diabetes was based on
      self-report, medication use, fasting plasma glucose levels, and hemoglobin A1c (HbA1c)
      levels. Individuals were characterized as reporting consumption of walnuts, mixed 'nuts', or
      no nuts.
    

Intervention name(s): Diabetes Outcome
Intervention type(s): Diagnostic Test
Intervention description(s): based on self report definition, fasting plasma glucose, and hemoglobin A1c
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The National Health and Nutrition Examination Survey (NHANES) is a cross-sectional,
        probability survey administered to the US civilian population aged from 0 to 85 years. This
        study used continuous NHANES data collected from 1999 to 2014, covering eight cycles of
        data collection (N=82,091). Participants were excluded from analysis for being under 18
        (N=34,735) and not having data on either day of the 24-hour food intake (N=6,533). In an
        attempt to have a control group free of nut consumers, individuals who consumed peanuts,
        but not other nuts on the day of recall, were excluded from the analysis (N=6,702). After
        exclusions, our analytic sample N was 34,121, representing a population size of
        approximately 176 million individuals.
      
Keywords: nut consumption; NHANES; epidemiology; plasma glucose; hemoglobin A1c
Effects of Docosahexaenoic Acid (DHA) on Children With Nonalcoholic Fatty Liver Disease (NAFLD)
Condition: Fatty Liver; Liver Fibrosis; Obesity; Metabolic Syndrome; Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Metabolic Syndrome; Fibrosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this interventional study is to evaluate the efficacy and tolerability of
      docosahexaenoic acid (DHA) in children or adolescents with well-characterized and liver
      biopsy confirmed nonalcoholic fatty liver disease (NAFLD).
    

Detailed description: 
      Sixty children or adolescents (4-16 years) with liver biopsy proven NAFLD will be enrolled.
      They will be randomized to treatment with DHA 250 mg/kg/d (n=20), DHA 500 mg/kg/d (n=20), or
      an identical placebo (n=20) given orally for a period of 24 months. All patients will be
      included in a lifestyle intervention program consisting of a diet tailored on the individual
      requirements and physical exercise.

      Patients will undergo a medical evaluation every three months during the 24-month study
      period. Liver biopsy will be performed only at baseline and at the end of treatment.
      Anthropometric analysis, laboratory tests, including liver enzymes and lipids will be
      repeated at 3-month intervals during the 24-month study duration. Ultrasonography and
      Fibroscan of the liver will be repeated at the end of the study period.
    

Intervention name(s): DHA250; DHA500; PLACEBO; Lifestyle intervention
Intervention type(s): Drug; Drug; Drug; Behavioral
Intervention description(s): DHA 250 mg/kg/d; DHA 500 mg/kg/d; placebo; lifestyle intervention [including hypocaloric diet (25-30 cal/kg/d) or isocaloric diet (40-45 cal/kg/d) and physical activity], for 12 months.
Other intervention name(s): Docosahexaenoic Acid; Docosahexaenoic Acid; No interventions; Diet and physical activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: NAFLD; NASH; fibrosis
Smartphone-Delivered Attentional Bias Modification Training in Helping Patients Quit Smoking
Condition: Current Every Day Smoker
Study type: Interventional

Summary: 
      This randomized clinical trial studies how well a smartphone-delivered attentional bias
      modification training works in helping patients quit smoking. Smartphone-delivered
      attentional bias modification training may help patients quit smoking by reducing the
      attentional bias (the tendency of one's perception to be affected by their recurring
      thoughts) towards smoking cues that developed over time as a result of conditioning processes
      through which smoking cues become important.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine the feasibility of smartphone-delivered, in-home attentional bias
      modification (ABM) to reduce attentional bias (AB) to smoking cues and to reduce smoking
      behavior in the short- and long-term.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM I: Patients receive ABM training over 30 minutes through a smartphone on days 1-14.
      Patients then receive nicotine patches for up to 8 weeks.

      ARM II: Patients undergo sham training on days 1-14. Patients then receive nicotine patches
      for up to 8 weeks.

      After completion of study treatment, patients are followed up on days 15, 29, 43, 57, and 72.
    

Intervention name(s): Computer-Assisted Smoking Cessation Intervention; Laboratory Biomarker Analysis; Nicotine Patch; Questionnaire Administration; Sham Intervention
Intervention type(s): Behavioral; Other; Drug; Other; Other
Intervention description(s): Receive ABM training via a smartphone; Correlative studies; Given via transdermal patch; Ancillary studies; Undergo sham training
Other intervention name(s): NicoDerm CQ; Nicotine Skin Patch; Nicotine Transdermal Patch
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Pulse Steroids Versus Oral Steroids in Problematic Hemangiomas of Infancy
Condition: Hemangiomas
MeSH terms: Hemangioma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine if pulse steroids are more efficacious and safer
      than the standard treatment with oral corticosteroids.
    

Detailed description: 
      Currently there is no prospective study in hemangioma patients answering critical questions
      such as: which type of steroid should be used,how much should we use and for how long. This
      study is an investigator blinded study with two arms:one arm is receiving standard treatment
      with daily oral corticosteroids and the other is receiving intravenous pulse corticosteroids
      daily for 3 days, monthly for 3 months. The main outcome of the study is assess the efficacy
      of each treament modality as the percentage improvement in the hemangioma's appearance. The
      secondary outcomes are the safety profiles of the two drugs and the changes in the
      angiogenesis markers as a result of treatment intervention.
    

Intervention name(s): prednisolone; methylprednisolone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Belzutifan (MK-6482) Hepatic Impairment Study (MK-6482-020)
Condition: Moderate Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to compare the plasma pharmacokinetics (PK) of
      belzutifan (MK-6482) following a single oral 80 mg dose of belzutifan in participants with
      moderate hepatic impairment to that of healthy matched control participants. This study will
      also evaluate the safety and tolerability of a single oral 80 mg dose of belzutifan in
      participants with moderate hepatic impairment.
    


Intervention name(s): Belzutifan
Intervention type(s): Drug
Intervention description(s): Two 40 mg tablets given as a single oral 80 mg dose.
Other intervention name(s): MK-6482; PT2977; WELIREG
Intervention MeSH terms: Belzutifan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Group
Masking: None (Open Label)
Primary purpose: Treatment
PK, PD, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomised, double blind, parallel group, multicentre study yo compare the
      pharmacokinetics, pharmacokinetics, safety and efficacy of SAIT101 versus MabThera® versus
      Rituxan® in patients with rheumatoid arthritis.
    

Detailed description: 
      This is a randomized, double-blind, parallel group, multicenter study to compare the
      pharmacokinetics (PK), pharmacodynamics (PD), safety, efficacy, tolerability, and
      immunogenicity of SAIT101 (biosimilar rituximab) versus MabThera® versus Rituxan® in patients
      with rheumatoid arthritis (RA). This study will take place globally across approximately 75
      study centers in order to randomize approximately 282 patients. The study consists of Part A
      from baseline for PK and efficacy analysis, followed by Part B from Week 24 to 52 for safety
      follow-up in which collects transition data.
    

Intervention name(s): SAIT101; MabThera; Rituxan
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 1,000 mg i.v. of SAIT101 on Day 1 and 15. 1,000 mg i.v. of SAIT101 on week 24 and 26 for eligible patients.; 1,000 mg i.v. of MabThera® on Day 1 and 15. 1,000 mg i.v. of MabThera® on week 24 and 26 for eligible patients.; 1,000 mg i.v. of Rituxan® on Day 1 and 15. 1,000 mg i.v. of Rituxan® on week 24 and 26 for eligible patients.
Other intervention name(s): Rituximab; Rituximab
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In Part A, patients are randomized in a 1:1:1 ratio to receive one course (baseline and Week 2) of SAIT101 (n=94) versus Rituxan® (n=94) versus MabThera® (n=94).
At Week 24, patients are evaluated for the second course (Week 24 and 26) of the infusion.
In Part B, eligible patients in the SAIT101 arm receive the second course of SAIT101 treatment. Eligible patients in the MabThera® arm receive the second course of MabThera® treatment. Eligible patients in the Rituxan® arm are randomized in a 1:1 ratio to receive SAIT101 or Rituxan® treatment. Patients are followed up for safety until Week 52.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: an inadequate response to anti -TNF therapy
Assessing the Diagnostic Accuracy of an On-line Questionnaire for Diagnosis of Primary Headache Disorders
Condition: Headache Disorders
MeSH terms: Headache Disorders; Headache Disorders, Primary; Headache
Study type: Observational

Summary: 
      Purpose of the study is to assess the diagnostic accuracy of an on- line questionnaire in
      comparison to a semi-structured interview administered by a trained interviewer.
    

Detailed description: 
      The worldwide current gold standard for diagnosing headaches is the International
      Classification of Headache Disorders (ICHD 3 beta). Adhering strictly to ICHD criteria has
      been problematic for accurately diagnosing patients in the clinic and as for clinical trials.
      To address these issues, an online instrument was developed that successfully diagnosis
      common primary and secondary headache disorders. In this research Investigator hopes to
      demonstrate an on- line questionnaire is non inferior to a semi-structured interview for
      accurately diagnosing different types of headaches (for example: episodic migraine vs. non
      episodic migraine, chronic migraine vs. non chronic migraine, episodic tension-type vs.
      non-episodic tension type, chronic tension-type headache vs. non chronic tension-type
      headache, medication overuse headache vs. non medication overuse headache, post traumatic
      headache vs. non post traumatic headache).

      Participants will be screened by telephone to see if participants meet the criteria for
      taking part in this research study. Once participant is deemed eligible,the participants will
      then be randomized in a 1:1 ratio to complete either the semi-structured interview over the
      phone first and then complete the online questionnaire or vice versa. Study is expected to
      enroll 500 participants with headache and healthy controls.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All race, gender age between 18-65, English speaking selected from community, clinic.