bioihbjkbjnl/mcl2 huggingface dataset:
Phase I Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of of PIPE-307 and Food Effect in Healthy Volunteers
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind study of PIPE-307 or placebo in normal healthy subjects.
      The study will be conducted in three parts: Part 1 will be a Single Ascending Dose (SAD)
      study enrolling approximately 48 subjects for a total duration of 6 weeks. Part 2 will be a
      Multiple Ascending Dose (MAD) study enrolling approximately 24 subjects for a total duration
      of 7 weeks, and part 3 will be a selected SAD cohort in a fed state to evaluate the effect of
      food on the bioavailability of PIPE-307, enrolling approximately 8 subjects from a selected
      SAD cohort for a duration of 6 weeks.
    

Detailed description: 
      This is a randomized, double-blind study of PIPE-307 or placebo given as single and multiple
      escalating doses in normal healthy subjects. The study will be conducted in three parts: Part
      1 will be a Single Ascending Dose (SAD) study enrolling approximately 48 subjects for a total
      duration of 6 weeks. Part 2 will be a Multiple Ascending Dose (MAD) study enrolling
      approximately 24 subjects for a total duration of 7 weeks, and part 3 will be a selected SAD
      cohort in a fed state to evaluate the effect of food on the bioavailability of PIPE-307,
      enrolling approximately 8 subjects from a selected SAD cohort for a duration of 6 weeks.
      Safety will be assessed by periodic measurement of vital signs, physical examinations,
      electrocardiograms, blood laboratory analyses and occurrence of adverse events (AE).
    

Intervention name(s): PIPE-307; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): Single and multiple ascending oral doses of PIPE-307 tablets; Single and multiple ascending oral doses of matching Placebo tablets
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Measles, Mumps and Rubella (MMR) Vaccine (209762) Compared to Merck & Co., Inc.'s MMR Vaccine in Healthy Children 12 to 15 Months of Age
Condition: Measles; Mumps; Rubella; Measles-Mumps-Rubella Vaccine
MeSH terms: Measles; Rubella; Mumps
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'
      trivalent MMR (Priorix), comparing it to Merck's MMR vaccine (M-M-R II), which is approved
      for use in the US in healthy children 12 to 15 months of age.
    

Detailed description: 
      This study will evaluate the safety of GSK's trivalent MMR vaccine (referred to as INV_MMR
      vaccine) at a potency that will be used to define maximum release limits for the INV_MMR in
      comparison to the US standard of care (M-M-R II/ M-M-R VaxPro vaccine referred to as COM_MMR
      vaccine). In order to obtain more representative data on the comparator vaccine, the COM_MMR
      used in this study will consist of two lots designated COM_MMR_L1 and COM_MMR_L2. Throughout
      the study COM_MMR_L1 and COM_MMR_L2 will be analyzed as pooled lots. This study is intended
      to support licensure of GSK's MMR vaccine in the US.

      All children will receive Varivax and Havrix vaccines, concomitantly with MMR containing
      vaccine at 12 to 15 months of age. Prevnar 13 will be administered only to US children. At
      the end of the study, GSK will provide a second dose of Havrix and/or varicella vaccine to
      participants enrolled in selected non-US countries if local health departments do not
      routinely provide hepatitis A and varicella vaccination. The second dose of Havrix and
      varicella vaccine is not part of the study procedures.
    

Intervention name(s): Priorix; M-M-R II; Varivax; Havrix; Prevnar 13
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 1 dose administered subcutaneously in the triceps region of left arm at Day 0; 1 dose administered subcutaneously in the triceps region of left arm at Day 0; 1 dose administered subcutaneously in the triceps region of right arm at Day 0; 1 dose administered intramuscularly in the anterolateral region of the right thigh at Day 0; 1 dose administered intramuscularly in the anterolateral region of the left thigh at Day 0 to subjects recruited in US
Other intervention name(s): GSK Biologicals' live attenuated measles; mumps and rubella (MMR) vaccine; MMR vaccine live (M-M R II; Merck & Co.; Inc.; or M-M-R VaxPro; Sanofi Pasteur/Merck Sharp and Dohme [SPMSD]); Merck & Co. Inc.'s Varicella virus vaccine; live; GSK Biologicals' Hepatitis A vaccine; inactivated; Pfizer Inc.'s Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Rubella; Healthy children; Measles; Safety; Mumps; 12 to 15 months; Immunogenicity
Mavoglurant in Alcohol Drinking
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this alcohol-interaction pilot study is to provide information on the effect
      of mavoglurant on the pharmacokinetics of alcohol and on alcohol responses, including
      stimulation, sedation, intoxication, body sway and physiological responses. The investigators
      propose to test the effects of 200 mg mavoglurant versus placebo on alcohol related
      responses. This is a between subjects double blind randomized design in which the
      investigators plan to run 40 subjects to obtain 28 completers.
    

Detailed description: 
      The purpose of this alcohol-interaction pilot study is to provide information on the effect
      of mavoglurant on the pharmacokinetics of alcohol and on alcohol responses, including
      stimulation, sedation, intoxication, body sway and physiological responses. The investigators
      propose to test the effects of 200 mg mavoglurant versus placebo on alcohol related
      responses. This is a between subjects double blind randomized design in which the
      investigators plan to run 40 subjects to obtain 28 completers.

      Subjects will participate in two lab sessions, one prior to taking medication and one
      following 7-10 days of mavoglurant/placebo. During each session, participants will receive
      successive doses of alcohol over a 90 min period designed to raise their blood alcohol levels
      to 80 mg/dl; this dose was chosen because this is close to the legal limit of intoxication
      and to the peak BAC the investigators have observed in prior research studies. Subjects will
      be monitored throughout the lab session and will receive a phone call two days following the
      2nd lab session and a follow-up appointment one week after the 2nd lab session to assess any
      remaining side effects from the medication.
    

Intervention name(s): Mavoglurant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg Mavoglurant; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Assessment of Two New Electronic Cigarettes in Cigarette Smokers
Condition: Electronic Cigarettes
Study type: Interventional

Summary: 
      The purpose of this study is to determine differences in nicotine delivery, user behavior,
      subjective effects, and physiological effects, when cigarette smokers use an two new
      electronic cigarette devices (JUUL and IQOS) relative to their using their own brand of
      cigarettes.
    


Intervention name(s): JUUL electronic cigarette; IQOS electronic cigarette; Own Brand cigarette
Intervention type(s): Other; Other; Other
Intervention description(s): Effects of JUUL electronic cigarette use.; Effects of IQOS electronic cigarette use.; Effects of own brand cigarette use.
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Epidemiological Data of Patients Consulted to Kayseri City Hospital Physical Therapy Clinic in the 2023 Kahramanmaraş Earthquake
Condition: in the Writing Process
Study type: Observational

Summary: 
      The quality of life of people after the earthquake is significantly affected. In particular,
      adequate and correct management of the damage caused by trauma on the human body is very
      important to reduce disability. Epidemiological information about the injury pattern from
      past earthquakes is crucial for preparedness and effective response to potential earthquakes
      in regions where resources are scarce. Thanks to the epidemiological data obtained from
      post-earthquake injury patterns, hospitals can be prepared for possible earthquakes, and
      disability and mortality can be reduced.

      Although many earthquake victims suffer injuries that require treatment, there are large gaps
      in knowledge regarding the epidemiology of earthquakes. It is essential to evaluate the data
      collected after the earthquake in the planning phase of the health demands of the earthquake
      area. Epidemiological studies on earthquakes guide the planning and organization of health
      services for hospitals located in and around the earthquake area. By knowing the injury
      patterns that will occur after the earthquake, the effectiveness of the early and specific
      treatments to be applied to the earthquake victims can be increased significantly. In this
      way, complications, disability and mortality rates that may occur in future natural disasters
      can be reduced. The aim of this study is to record the injury patterns and treatments of the
      patients who were consulted to the physical therapy and rehabilitation clinic after the 2023
      Kahramanmaraş earthquake in our country, which is an earthquake zone, and to ensure that the
      physical therapy physicians meet the possible earthquakes in a more knowledgeable,
      experienced and prepared manner.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 220 patients who were hospitalized due to injury and illness due to the 2023
        Kahramanmaraş earthquake and were consulted to the physical therapy unit were examined.
      
Keywords: 2023 Kahramanmaraş, earthquake
Anti-Mullerian Hormone (AMH) is a Marker for Ovarian Reserve. There Are Many Studies About AMH Changes in Ovarian Surgery, But Little is Known for Other Surgeries. We Seek to Investigate the Hormone Variations Before and After Uterine Artey Ligation for Postpartum Hemorrage (PPH)
Condition: Anti-Mullerian Hormone Deficiency; Post Partum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Observational

Summary: 
      Anti-Mullerian hormone (AMH) is a marker for ovarian reserve. There are many studies about
      AMH changes in ovarian surgery, but little is known for other surgeries. We seek to
      investigate the hormone variations before and after uterine artey ligation for postpartum
      hemorrage (PPH)
    

Detailed description: 
      All patients belong to the same group. The blood samples will be collected at the time of
      surgery and 3 months after surgery from the patients who need uterine artery ligation for
      PPH. The blood samples will be centrifuged within 2 hours after being obtained and assessed
      on the same day. AMH concentrations will be measured with an enzymatically amplified
      two-sided immunoassay
    

Intervention name(s): anti- mullerian hormone
Intervention type(s): Other
Intervention description(s): All patients belong to the same group. The blood samples will be collected at the time of surgery and 3 months after surgery from the patients who need uterine artery ligation for PPH. The blood samples will be centrifuged within 2 hours after being obtained and assessed on the same day. AMH concentrations will be measured with an enzymatically amplified two-sided immunoassay
Intervention MeSH terms: Hormones
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients who need artery ligation for PPH during C-section.
Efficacy and Safety Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines
Condition: Lateral Canthal Lines; Crow's Feet; Facial Wrinkles
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of 2 sequential doses of
      RT001 compared to placebo gel to treat moderate to severe lateral canthal lines in adults.
    

Detailed description: 
      This is a double-blind, randomized, parallel-group, controlled, repeat dose, single center
      study to evaluate the efficacy and safety of a repeat application of RT001 compared to
      placebo gel in at least 36 subjects with moderate to severe lateral canthal lines (LCL).
      Subjects will be randomized to 1 of 2 treatment groups in a 1:1 ratio (active versus
      placebo). At least 36 adult volunteers who have provided informed consent and have met the
      study eligibility criteria will be enrolled. There will be 18 subjects in each treatment
      group.
    

Intervention name(s): Botulinum Toxin Type A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): RT001 (Botulinum Toxin Type A Topical Gel) Dose A applied topically at Baseline (Day 0) and at Week 4 on the lateral canthal areas; Placebo (Dose B) applied topically at Baseline (Day 0) and at Week 4 on the lateral canthal areas
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Lateral Canthal Lines; Crow's Feet; Facial Wrinkles
Use of a Mobile-based App for SCD Patients
Condition: Sickle Cell Disease; Chronic Pain
MeSH terms: Anemia, Sickle Cell; Chronic Pain
Study type: Observational

Summary: 
      The study will seek to enroll 100 sickle cell or thalassemia patients who are age 12 or older
      who have access to a smartphone or tablet with Internet access daily.

      The study will evaluate patient-reported comfort level with using a mobile device to record
      their pain levels, as well as adherence to recording these levels daily.

      The study will track patients' assessment of their pain, actions taken, and outcomes related
      to pain management and provider involvement.

      This study will attempt to collect information about differences in the use of two
      traditional pain assessment modes (verbal scale and paper) versus the use of a pain
      assessment tool on a mobile device in the form of a smartphone, tablet, or iPad with an
      Android or iOS operating system.
    

Detailed description: 
      The study will evaluate patient-reported comfort level with using a mobile device to record
      their pain levels, as well as adherence to recording these levels daily. The study will track
      patients' assessment of their pain, actions taken, and outcomes related to pain management
      and provider involvement. This study will attempt to collect information about differences in
      the use of two traditional pain assessment modes (verbal scale and paper) versus the use of a
      pain assessment tool on a mobile device in the form of a smartphone, tablet, or iPad with an
      Android or iOS operating system. The study will seek to enroll 100 sickle cell or thalassemia
      patients who are age 12 or older who have access to a smartphone or tablet with Internet
      access daily. Patients enrolled in this study will be ask to use a mobile device such as a
      smartphone or a tablet with Android or iOS operating system to record daily pain level and
      related information once daily or more frequently for a period of forty-two days. A 1:1
      randomization assignment will be made to have patients receive automated "canned" provider
      feedback or not.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients experiencing pain or patients with sickle cell disease
      
Keywords: Sickle cell; Pain
Depression, Anxiety and Stress in High School
Condition: Depression; Anxiety; Stress
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Observational

Summary: 
      Background: Social isolation secondary to the pandemic can predispose the population to
      mental health issues in the future, especially teenagers. The Depression, Anxiety, and Stress
      Scale (DASS) is a valuable self-report scale since it may be used to screen for anxiety,
      depression, and stress in one questionnaire. In the last years, it has been observed
      effective in detecting these symptoms in teenagers.

      Aims: Identify the prevalence of depression, anxiety, and stress in high school students
      during the COVID-19 pandemic This is an observational cross-sectional study.

      For this study, the validated Spanish version of DASS-21 will be used. Qualitative variables
      will be evaluated through central tendencies, such as mean, standard deviation, and
      frequencies. The inferential analysis of categorical variables will be performed using the
      chi-squared test, analysis of variance (ANOVA), or Kruskal Wallis test as appropriate. For
      quantitative variables, Student's t-test or Mann Whitney U test will be performed depending
      on their distribution.
    


Intervention name(s): DASS-21 scale
Intervention type(s): Diagnostic Test
Intervention description(s): Each construct consists of 7 questions. The participants must select the answer that better represents their feelings over the last week in each scenario. Each question has a Likert scale of 4 options where 0 represents "did not apply to me" to 3 "applied to me very much.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adolescents from 14 to 22 years old with an average age of 16 years are high school
        students.
Effect of Metamizole (Dipyrone) on Renal Function in Salt-depleted Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The planned study is a single-center, randomized, open-label parallel group study in 16
      healthy male subjects. Study subjects will be randomly allocated either to the metamizole
      group (1) or to the naproxen group (2). All participants will start with a low sodium diet
      (approximately 50 mmol Na+ per day) 7 days before the first drug intake and maintain the diet
      until the end of the study (14 days in total). Salt-depletion is an accepted model to enhance
      production of vasodilatory prostaglandins and to increase renal sensitivity to prostaglandin
      inhibition. On the first day of treatment (Day 1), a single dose of metamizole or naproxen
      will be administered to investigate the effects after a single dose and to collect single
      dose pharmacokinetic profiles. Starting on Day 2, all participants will receive therapeutic
      doses, i.e. 1000 mg metamizole 'ter in die' (TID, three times a day) or 500 mg naproxen 'bis
      in die' (BID, twice a day) for one week and on Day 7 pharmacokinetics and pharmacodynamics
      effects will be assessed under near steady-state conditions.

      The primary objective is the characterization of the renal effects of metamizole by
      determination of the glomerular filtration rate (GFR) using the inulin clearance. Secondary
      objectives are the characterization of the urinary excretion of prostaglandin E2 (PGE2) and
      the prostaglandin I2 (PGI2) metabolite 6-keto-prostaglandin F1 (PGF1)alpha as well as the
      urinary excretion of sodium and potassium.

      Overall, clinical experience suggests better renal tolerability of metamizole possibly due to
      less potent COX-inhibition compared to classical nonsteroidal antiinflammatory drugs
      (NSAIDs). If this could be confirmed, metamizole would be a valuable alternative for
      treatment of painful conditions in patients with impaired renal function. Therefore, the aim
      of this study is to examine the effects of metamizole on renal function in comparison with
      the non-specific COX-inhibitor naproxen.
    


Intervention name(s): metamizole; Naproxen
Intervention type(s): Drug; Drug
Intervention description(s): metamizol tablets (500mg): 1000mg TID during 7 days; Naproxen tablets (500mg): 500 mg BID during 7 days
Other intervention name(s): dipyrone; Naproxen sodium
Intervention MeSH terms: Dipyrone; Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Effect; metamizole; salt-depleted; subjects
Measurement Variability of Liver Metastases From Neuroendocrine Tumors on Different Magnetic Resonance Imaging Sequences
Condition: Neuroendocrine Tumors
MeSH terms: Neuroendocrine Tumors
Study type: Observational

Summary: 
      The aim of our study is to assess variability of measurements of liver metastases from
      neuroendocrine tumors (NET) on different magnetic resonance imaging (MRI) sequences.

      In this institutional review board-approved retrospective study from January 2011 to December
      2012, all liver MRIs performed at our department in patients with proven liver metastases
      from NETs and with at least one measurable lesion according to Response evaluation criteria
      in solid tumors (RECIST 1.1) were included.
    

Detailed description: 
      The aim of our study is to assess variability of measurements of liver metastases from
      neuroendocrine tumors (NET) on different magnetic resonance imaging (MRI) sequences.

      In this institutional review board-approved retrospective study from January 2011 to December
      2012, all liver MRIs performed at our department in patients with proven liver metastases
      from NETs and with at least one measurable lesion according to Response evaluation criteria
      in solid tumors (RECIST 1.1) were included. Up to two lesions were selected by an independent
      radiologist on T2-weighted images and marked by an arrow. Three reviewers (attending
      radiologist R1, fellow R2, senior R3) independently obtained long axis measurements of 135
      metastases in 30 patients, on T2, diffusion-weighted imaging (DWI) with three b values (50,
      400, 800), arterial, portal and late phases after gadolinium ), and during two distant
      separate sessions. Intraclass correlation coefficients and Bland-Altman plots were used to
      assess intra-and interobserver variability.
    

Intervention name(s): magnetic resonance imaging
Intervention type(s): Other
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with liver metastasis from neuroendocrine tumor with a magnetic resonance imaging
        in Reims university hospital.
      
Keywords: Neuroendocrine tumor