bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Multiple Doses of LY3305677 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to determine:

        -  The safety of LY3305677 and any side effects that might be associated with it.

        -  How much LY3305677 gets into the bloodstream and how long it takes the body to remove it
           in healthy participants, including those of Japanese origin.

        -  The effect LY3305677 has on the body, particularly the effect on blood glucose levels.

      This study will last approximately 17 weeks not including screening. Screening is required
      within 4 weeks prior to start of the study.

      This study is for research purposes only and is not intended to treat any medical conditions.
    


Intervention name(s): LY3305677; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study to Evaluate the Effects of Synthetic Conjugated Estrogens, B (SCE-B) on Nocturnal Vasomotor Symptoms in Postmenopausal Women
Condition: Nocturnal Vasomotor Symptoms
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multi-center study to evaluate the effects of SCE-B on nocturnal vasomotor
      symptoms. Study duration will be approximately 16 weeks; this includes a 4-week screening
      period and approximately 5 scheduled clinic visits. Participants will receive one of two
      strengths of SCE-B tablets plus matching placebo or placebo only, and will have a physical
      and gynecological exams that may include transvaginal ultrasound, endometrial biopsy and a
      pap smear. Participants will be asked to wear a monitoring device for a portion of the study
      and be asked to complete a daily dairy.
    


Intervention name(s): SCE-B; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.3 mg or 0.625 mg SCE-B tablets daily plus matching placebo; Matching placebo for 0.3 mg and 0.625 mg tablets
Other intervention name(s): Synthetic Conjugated Estrogens, B; Enjuvia
Intervention MeSH terms: Estrogens; Estrogens, Conjugated (USP); Estrogens, conjugated synthetic A; Estrogens, conjugated synthetic B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Nocturnal vasomotor symptoms in postmenopausal women
Safety and Pharmacokinetics Study of FBF001
Condition: Avian Influenza
MeSH terms: Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the clinical and laboratory safety and to determine
      the pharmacokinetic profile of FBF001.
    


Intervention name(s): FBF001; Placebo
Intervention type(s): Biological; Drug
Other intervention name(s): Sodium chloride 0.9%
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions.
Condition: Primary Ovarian Insufficiency; Vaginitis; Metrorrhagia; Menopause
MeSH terms: Vaginitis; Primary Ovarian Insufficiency; Menopause, Premature; Metrorrhagia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence and food effect for a new Premarin
      formulation compared with a Premarin reference tablet in Japanese healthy postmenopausal
      women.
    


Intervention name(s): Premarin reference tablet (fasted); Premarin new tablet (fasted); Premarin reference tablet (fed); Premarin new tablet (fed)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Premarin reference tablet, single dose, fasted conditions; Premarin new tablet, single dose, fasted conditions; Premarin reference tablet, single dose, fed conditions; Premarin new tablet, single dose, fed conditions
Intervention MeSH terms: Estrogens, Conjugated (USP)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bioequivalence; menometrorrhagia; climacteric disturbance; Estrogen Replacement Therapy; Estrogens Conjugated
Effects of Big Toe Strengthening on Agility, Jump and Speed Among Runners
Condition: Sports Physical Therapy
Study type: Interventional

Summary: 
      Running form and technique have a direct influence on a runner's economy, and therefore small
      changes in specific running mechanics could be useful to improving running performance. The
      thumb plays an important role in the functionality of the foot. During standing, the big toe
      is more loaded than the head of the five metatarsals and the heel.

      The study design will be a Randomized Controlled Trial. This study will be conducted in
      Pakistan Sports Board (PSB) Lahore. The study will be completed within the time duration of
      eight to ten months after the approval of the synopsis. The sample size will be 30 subjects.
      Non-probability convenient sampling technique will be used to recruit the individuals for the
      study. Then randomization will be done by lottery method to divide the individuals into 2
      treatment groups. The experimental group is given big toe strengthening program for 3 weeks
      along with running training on the other hand control group will do only their running
      training and after that measure their pre-post values on spss.

      In this study, it will be aimed to examine the relationship of big toe strength with
      parameters that affect anaerobic athletic performance in runners such as vertical jump,
      horizontally jumping, strength, agility and speed.
    

Detailed description: 
      The objective of my study is to explore the effects of big toe strengthening on agility, jump
      and speed among runners.
    

Intervention name(s): Toe strengthening exercise; Control Group
Intervention type(s): Other; Other
Intervention description(s): 12 participants will be in experimental group giving them Toe strengthening exercise protocol along with running training for three weeks, measure all values before giving them protocol and after protocol.; 12 participants will be in control group they will do only there running training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Big toe; Athlete; Dynamometer; Muscle Strength; Agility
Smoking Cessation in Women With Gynecological Conditions
Condition: Cervical Dysplasia
MeSH terms: Uterine Cervical Dysplasia
Study type: Interventional

Summary: 
      This feasibility study will compare two smoking cessation methods, traditional nicotine
      replacement therapy and Electronic Nicotine Delivery Systems (electronic cigarettes) in
      patients with gynecological conditions.
    

Detailed description: 
      This study will allow women with serious gynecological conditions to sample both traditional
      nicotine replacement therapy (NRT) and Electronic Nicotine Delivery Systems (electronic
      cigarettes, ENDS). Whether the woman samples NRT or ENDS first will be randomized. Women will
      choose the product they wish to try for a 6-week intervention period for smoking cessation.
      Women choosing NRT will receive a 6-week intervention of a daily nicotine patch plus either
      nicotine gum or lozenges to use (as needed) throughout the day. The ENDS group will receive
      an electronic cigarette device with refills to last the 6-week duration of the study. Both
      groups will receive identical tobacco cessation counseling. As part of the study, each
      subject will complete a survey conducted at baseline, 6-weeks into the study during
      intervention, and upon completion of a 6 week follow-up period in which participants receive
      no intervention. At the 12-week measurement period we will add a qualitative interview that
      will allow us to ask the women whether the methods were acceptable, caused any problems, and
      if so, what the problems entailed.
    

Intervention name(s): Nicotine Replacement Therapy; Electronic Cigarettes
Intervention type(s): Other; Device
Intervention description(s): Patients will use one patch per day for 6 weeks for a total of 42 patches - they will receive 7 the first visit and then the additional 35 at the second visit. Women will receive 3 weeks of original strength nicotine patches, and will receive patches half as strong during the last 3 weeks of the study. This will allow for a lower strength of nicotine as each woman continues with smoking cessation.; The number of cartridges for the electronic cigarettes is determined by asking each patient the number of packs currently smoked per day, and multiplying 1.5 times the number of packs smoked per day. We plan to decrease the strength of the cartridges by one half after three weeks of intervention. We will give each women supplies and instructions accordingly. This will allow for a lower strength of nicotine as each woman continues with smoking cessation
Other intervention name(s): Nicoderm CQ patches (21 or 14 mg patches); Nicorette gum (2 mg); Nicorette lozenges (2 mg); Blu Cig Electronic Nicotine Delivery System
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking cessation; Traditional nicotine replacement therapy; Electronic nicotine delivery devices; electronic cigarettes; cervical dysplasia
A Pilot Study of Boredom in a Community Sample of Adolescents and a Clinical Sample of Adolescents
Condition: Mental Disorders; Affective Disorders; Anxiety Disorders; Attention Deficit and Disruptive Behavior Disorders; Psychotic Disorders
MeSH terms: Anxiety Disorders; Mental Disorders; Psychotic Disorders; Mood Disorders; Problem Behavior; Attention Deficit and Disruptive Behavior Disorders
Study type: Observational

Summary: 
      The aim of the following pilot study is to examine boredom in a community sample of
      adolescents and a clinical sample of adolescents. This is important in order to examine
      differences among healthy adolescents and adolescents with mental illness.
    

Detailed description: 
      Boredom has been recognized as a significant problem in a wide variety of areas. However,
      limited research has been focused on this construct (Vodanovich & Watt, 1999). Research into
      boredom in adolescents is especially lacking in the psychological literature. This is
      surprising given that adolescence is a time marked by change, stress, and identity issues.

      The aim of the following pilot study is to examine boredom in a community sample of
      adolescents and a clinical sample of adolescents. This is important in order to examine
      differences among healthy adolescents and adolescents with mental illness, such as
      depression, anxiety, and ADHD. This has implications for both prevention and intervention
      strategies and programs, such as the assessment and treatment of adolescents with mental
      illness. Hence, the results of this study will be important in providing an evidence-based
      practice in the treatment of mental illness in adolescents.

      Participants will be asked to complete one survey, the Boredom Proneness Scale (Farmer &
      Sundberg, 1986), and a demographic background form to measure gender, date of birth, country
      of birth, etc. The community sample of adolescents will be recruited from secondary schools
      in Victoria. The clinical sample of adolescents will be recruited from the Alfred Child and
      Adolescent Mental Health Service. It is envisaged that about 100 adolescents from each sample
      will be recruited to participate.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adolescents
      
Keywords: Boredom; Adolescent; Mental illness; Depression; Anxiety
Pharmacokinetic and Safety Study of Naltrexone Release From Subcutaneous BICX104 Pellets Compared to Vivitrol Injections
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, 6-month, open-label, multi-center study in parallel groups of randomized
      healthy volunteers to evaluate the pharmacokinetics and safety of BICX104 implantable
      subcutaneous naltrexone pellets and Vivitrol intramuscular depot naltrexone injection.
    


Intervention name(s): BICX104; Vivitrol
Intervention type(s): Drug; Drug
Intervention description(s): Erodable implantable pellet containing 1 g naltrexone and 11 mg magnesium stearate.; Intramuscular injection containing 380 mg of naltrexone.
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Culture Media Microdroplet Geometry With Different Oil Overlay and Its Effect on Embryonic Development.
Condition: Embryonic Development; Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      A prospective randomized study included 1695 MII sibling oocytes collected from 100 patients
      undergoing ICSI.
    

Detailed description: 
      Purpose:

      to determine the effect of culture media microdroplet geometry of different culture dishes
      and oil overlay on the pre implantation embryo development in dry incubators

      Method:

      We used sibling oocytes splits between two different dishes : GPS (life global, USA) and SPL
      (life science, Korea) with two different oils : light mineral oil (LM)(Irvine, USA) and
      paraffin oil (PO)(Vitro life, Sweden). All embryos cultured in dry incubators at the same
      conditions.

      statistical analysis done using SPSS version 23
    

Intervention name(s): GPS/LM; SPL/LM; GPS/PO; SPL/PO
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Media microdroplet geometry (3D dishes) in combination with light mineral oil overlay; Media microdroplet geometry (2D dishes) in combination with light mineral oil overlay; Media microdroplet geometry (3D dishes) in combination with Paraffin oil overlay; Media microdroplet geometry (2D dishes) in combination with paraffin oil overlay
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Effect of two different culture dishes with two different oil overlay which used in human embryos culturing through ICSI procedures on the pre implantaion embryonic development.
Masking: None (Open Label)
Primary purpose: Other
Keywords: dry incubator; Osmolality; Oil overlay; Microdrops
Safety of Testosterone Undecanoate i.m. in Hypogonadal Men
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      Treatment of male hypogonadism by testosterone substitution has be monitored in terms of
      safety. This study relates to safety of a new long-acting preparation.
    

Detailed description: 
      A reliable form of androgen substitution therapy regarding kinetics, tolerance and
      restoration of androgenicity is paramount in hypogonadal men. Intramuscular injection of the
      long-acting ester testosterone undecanoate (TU) offers a new modality.

      The objective is to assess safety of TU regarding metabolic and pharmacogenetic confounders
      in hypogonadal men treated with this new formulation.

      This is a longitudinal prospective one-arm open intervention and observation trial. A minimum
      of 5 individual assessments is a prerequisite. Investigated modulators of safety parameters
      entering regression models are: nadir and/or delta total testosterone concentrations, body
      mass index (BMI), and age.

      The setting Andrological outpatient department.
    

Intervention name(s): Testosterone Substitution by Testosterone Undecanoate i.m.
Intervention type(s): Drug
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Testosterone; Hypogonadism; Safety
Yoga to Reduce Fatigue in Hospitalized Children Receiving Intensive Chemotherapy
Condition: Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      Cancer-related fatigue (CRF) is a major problem in children, adolescents and adults receiving
      treatment for cancer, and intensively treated patients may be at higher risk. While exercise
      is an effective intervention for CRF, patients receiving the most intensive chemotherapy may
      frequently be too ill to participate in a standardized exercise program. A unique
      intervention that combines exercise and relaxation is yoga. This pilot study will evaluate
      the feasibility of three times weekly yoga sessions administered by a trained yoga instructor
      for a three week duration and will enroll between 10 and 20 children. If feasible, the
      intervention will be tested in a randomized controlled trial.
    


Intervention name(s): Individualized Yoga Intervention
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fatigue; quality of life; chemotherapy; haematopoietic stem cell transplantation; children; pilot; yoga
High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy
Condition: Spinal and Bulbar Muscular Atrophy; Healthy Subjects
MeSH terms: Muscular Atrophy; Bulbo-Spinal Atrophy, X-Linked; Atrophy
Study type: Interventional

Summary: 
      We want investigate if high intensity training can increase daily functionality without
      causing muscle damage in patients Spinal and Bulbar Muscular Atrophy . We want to study if
      there is a difference in effect with supervised and unsupervised training. Furthermore we
      want to study if a supervised training program will motivate participants to continue
      training by the end of the program.
    


Intervention name(s): Supervised high intensity training; Optional training; Control period; Unsupervised High intensity training
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 8 weeks of supervised training; 8 weeks of optional training on cycle ergometer. No program needs to be followed. Participant decides whether they want to keep training or not.; 8 weeks with no training.; 8 weeks of unsupervised high intensity training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Kennedy's disease; Spinal and bulbar muscular atrophy; High Intensity Training; High Intensity Interval Training; HIT; HIIT; Training; Exercise; 10-20-30
An Evaluation of Safety and Feasibility Using Repetitive Transcranial Magnetic Stimulation (rTMS) in Adolescents With Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The objective of this investigation is to examine the safety and feasibility of a series of
      repetitive transcranial magnetic stimulation (rTMS) treatments (10 Hertz [Hz]; Left
      Dorsolateral Prefrontal Cortex), with a Neuronetics Model 2100 Therapy System as adjuvant
      treatment for depression in adolescent subjects.
    

Detailed description: 
      High frequency rTMS applied to the left dorsolateral prefrontal cortex (L-DLPFC) has been
      shown to have an antidepressant effect. Initial studies comparing electroconvulsive therapy
      (ECT) and rTMS suggest that rTMS has been as effective as ECT in treating non-psychotic
      depression. Given the high degree of ongoing dysfunction in depressed adolescents despite
      optimization of treatment with antidepressant medications, new concerns regarding suicidal
      thoughts and behaviors in adolescents treated with antidepressant medications, and the more
      interventional nature of ECT, the use of rTMS as adjuvant therapy may be of significant
      clinical benefit. Thus far, research using rTMS to treat depression in adolescents has been
      limited. The primary aim of this study is to examine the safety and feasibility of using 10
      Hz rTMS applied to the left dorsolateral prefrontal cortex (L-DLPFC) as adjuvant treatment
      for depression in adolescents.
    

Intervention name(s): rTMS Treatment
Intervention type(s): Device
Intervention description(s): Active rTMS treatment.
Other intervention name(s): Neuronetics Model 2100 Therapy System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescent; Depression; rTMS
Bone Health in Pregnancy
Condition: Pregnancy
Study type: Interventional

Summary: 
      Women between the ages of 18 and 45 are needed for a study that looks at the effect of
      calcium supplementation on bone health during pregnancy in black and white women. Study
      subjects will be divided into two groups. Each group will take 2 study supplements each day,
      the supplement will be calcium or placebo (a pill without calcium). The study involves five
      visits to the Children's Hospital of Oakland Research Institute; each visit will be 1-2 hours
      in length. There are 3 study visits during pregnancy and 2 in the first year after delivery.
      At each visit you will have your blood drawn and be asked questions about what you eat and
      what type of activities you do. At visit 16 and 36 weeks and 4 and 12 months postpartum you
      will have your bone density measured. You will be paid $240 for completing the study.
    

Detailed description: 
      Women between the ages of 18 and 45 are needed for a study that looks at the effect of
      calcium supplementation on bone health during pregnancy in black and white women. Study
      subjects will be divided into two groups. Each group will take 2 study supplements each day,
      the supplement will be calcium or placebo (a pill without calcium). The study involves five
      visits to the Children's Hospital of Oakland Research Institute; each visit will be 1-2 hours
      in length. There are 3 study visits during pregnancy and 2 in the first year after delivery.
      At each visit you will have your blood drawn and be asked questions about what you eat and
      what type of activities you do. At visit 16 and 36 weeks and 4 and 12 months postpartum you
      will have your bone density measured. You will be paid $240 for completing the study.
    

Intervention name(s): Calcium or Placebo
Intervention type(s): Dietary Supplement
Intervention description(s): Participants are randomized to take either 1000mg of calcium or placebo from week 16 of pregnancy until delivery.
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: calcium; vitamin D; bone; pregnancy