bioihbjkbjnl/mcl2 huggingface dataset:
Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters
Condition: Male Infertility; HCV
MeSH terms: Hepatitis C; Infertility; Infertility, Male
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Hepatitis C virus is commona viral infection. Direct-acting antiviral (DAA) oral drugs has
      been used in treatment of HCVs. the effect of these drugs on male infertility is still under
      investigation.
    

Detailed description: 
      Semen analysis will be done to male patients with HCV before and after treatment with DAA.
      The included men will take therapy for 3 months and HCV RNA titter will be evaluated. changes
      of seminal parameters will be recorded and analyzed.
    

Intervention name(s): Sofosbuvir +daclatasvir+ simeprevir+Ribavirin
Intervention type(s): Drug
Intervention description(s): Oral daily dose of Sofosbuvir +daclatasvir + simeprevir+ Ribavirin for 3 months
Intervention MeSH terms: Ribavirin; Sofosbuvir; Simeprevir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: DAA oral therapy for HCV.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Semen; DAA; Male infertility
Bioavailability and Effect of Food on TAK-385 Tablet Formulations in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the oral bioavailability of two new tablet
      formulations of TAK-385 (T4 Formulation B and T4 Formulation C) under fasted and fed
      conditions, relative the T2 Formulation tablet; and to estimate the effect of food on the
      pharmacokinetics (PK) of a single oral dose of the T4 Formulation B tablet and the T4
      Formulation C tablet.
    

Detailed description: 
      The drug being tested in this study is called TAK-385. In this study, two new formulations of
      TAK-385 are being evaluated under fasted and fed conditions, relative to a previous
      formulation of TAK-385, to assess its bioavailability and how it is processed by the body.
      This study will look at lab results of people who take TAK-385.

      The study will enroll approximately 54 patients. Participants will be randomly assigned (by
      chance, like flipping a coin) to one of the two treatment groups (Arms). Participants in Arm
      1 will receive TAK-385 T2 Formulation 120 mg tablet (80mg + 40mg tablets) under fasted
      conditions, TAK-385 T4 Formulation B 120 mg tablet under fasted conditions, and TAK-385 T4
      Formulation B 120 mg tablet under fed conditions. Participants in Arm 2 will receive TAK-385
      T2 Formulation 120 mg tablet (80mg + 40mg tablets) under fasted conditions, TAK-385 T4
      Formulation C 120 mg tablet under fasted conditions, and TAK-385 T4 Formulation C 120 mg
      tablet under fed conditions. Participants in each arm will be randomized to receive study
      drug in one of 6 treatment sequences. Study medication will be administered as a single dose
      on Days 1, 11 and 21. There will be a 10-day washout period between each dose.

      This single-centre trial will be conducted in the United States. The overall time to
      participate in this study is 51 days. Participants will make 10 visits to the clinic,
      including three 4-day periods of confinement to the clinic, and will be contacted by
      telephone 30 days after last dose of study drug for a follow-up assessment.
    

Intervention name(s): TAK-385 T2 Formulation; TAK-385 T4 Formulation B; TAK-385 T4 Formulation C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TAK-385 T2 Formulation tablets; TAK-385 T4 Formulation B tablets; TAK-385 T4 Formulation C tablets
Intervention MeSH terms: Relugolix
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug therapy
Social Influences on Adolescents' Snack Purchases
Condition: Social Influences; Food Consumption
Study type: Observational

Summary: 
      The purpose of this study is to assess the effects of peer influences on snack purchases in
      adolescents. During the session teens will be given a certain amount of money to use to
      purchase foods and beverages in a hypothetical convenience store setting.

      The investigators hypothesize that overweight youth will be less responsive to own-price
      elasticity for high calorie foods and less likely to show cross price elasticity for low
      calorie foods when the price of the high calorie for nutrient foods increases. The
      investigators also predict that overweight youth will show more cross price elasticity for
      low calorie foods when in the presence of peers; whereas lean youth's food purchases and
      price sensitivity will not be affected by the presence of peers.
    


Keywords: social influences; food purchases; childhood obesity; amount of energy dense food and beverage items purchased; amount of nutrient dense food and beverage items purchased
A Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets and 100 mg Trazodone Hydrochloride Immediate-release Tablets at Steady State
Condition: Healthy Subjects; Bioavailability; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to compare the pharmacokinetic profiles at steady state of the
      test product, 300 mg trazodone hydrochloride (HCl) extended-release caplets (containing
      Contramid®), when administered once daily, and the reference product, 100 mg trazodone HCl
      immediate-release tablets (Apotex Corp.), when administered three times daily, for one week.
      For this purpose, the rate and extent of absorption of trazodone and formation of
      m-chlorophenylpiperazine (mCPP) after administration of multiple doses of up to 300 mg of
      each of the two formulations was compared.
    


Intervention name(s): Trazodone HCl; Trazodone HCl
Intervention type(s): Drug; Drug
Intervention description(s): Dosage form:
Extended-release caplets containing 300 mg trazodone HCl and extended-release caplets containing 150 mg trazodone HCl (the 150 mg dosage form was only used for the up and down titration, and was not evaluated in the study).
Dose regimen:
75 mg trazodone HCl (½ x 150 mg extended-release caplet) on Days 1 and 11, 150 mg trazodone HCl (one extended-release caplet) on Days 2 and 10, 300 mg trazodone HCl (one extended-release caplet) on Days 3 to 9, each at 23:30 after a fast of at least 4 hours.; Dosage form:
Immediate-release tablet containing 100 mg trazodone HCl
Dose regimen:
100 mg trazodone HCl (one immediate-release tablet) once (at 23:30) on Days 1 and 11, 100 mg trazodone HCl (one immediate-release tablet) twice (at 23:30 and 11:30) on Days 2 and 10, 100 mg trazodone HCl (one immediate-release tablet) three times daily (at 23:30, 07:30 and 15:30) on Days 3 to 9. Evening doses were administered after a fast of at least 4 hours.
Other intervention name(s): Oleptro
Intervention MeSH terms: Trazodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy subjects; Bioavailability; Pharmacokinetics; Trazodone; Steady-state
Changes on Pain and Range of Motion by the Use of Kinesio Taping in Patients Diagnosed With Cervical Pain
Condition: Mobility Limitation; Myofascial Trigger Point Pain
MeSH terms: Myofascial Pain Syndromes; Mobility Limitation; Neck Pain
Study type: Interventional

Summary: 
      The aim of this study is to demonstrate that the application of Kinesio Taping on a
      myofascial trigger point in the trapezius muscle able to cause a decrease of the pain and an
      increase of the cervical range of motion in patients diagnosed with cervical pain.
    

Detailed description: 
      The use of Kinesio Taping has become very popular for the treatment of many musculoskeletal
      disorders in recent decades. Of the six variants of application that has the Kinesio Taping,
      the space correction technique is suggested for pain management. The increased space achieved
      with this variant decreases the pressure by raising the skin directly over the treatment
      area, reducing chemical irritation receptors and therefore pain. The aim of this study is to
      demonstrate that the application of this variant of Kinesio Taping on a myofascial trigger
      point in the trapezius muscle able to cause a decrease of the pain and an increase of the
      cervical range of motion in patients diagnosed with cervical pain. For this, the pressure
      pain threshold will be measured with a algometer on the trigger point, the perception of pain
      with a visual analog scale and the range of motion with a cervical goniometer.
    

Intervention name(s): Kinesio Taping; Sham Kinesio Taping
Intervention type(s): Device; Device
Intervention description(s): Four Kinesio Taping strips will be placed with tension on skin forming an asterisk. The point of intersection of the four strips will be just above the myofascial trigger point. The subject will remain three days with the strips on his skin; Four Kinesio Taping strips will be placed without tension on skin forming an asterisk. The point of intersection of the four strips will be just above the myofascial trigger point. The subject will remain three days with the strips on his skin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Evaluation of Ropinirole CR-RLS ( SK&F101468)Tablets in Restless Legs Syndrome
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was designed to evaluate the safety, pharmacokinetic profile and efficacy in
      Restless Legs Syndrome patients.
    


Intervention name(s): ropinirole controlled release (CR)-RLS
Intervention type(s): Drug
Intervention description(s): White film-coated round-shaped tablet
Other intervention name(s): Ropinirole CR-RLS (SK&F101468)
Intervention MeSH terms: Ropinirole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Restless Legs Syndrome
Bucillamine for the Treatment of Acute Gout Flare in Subjects With Moderate to Severe Gout
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase IIA, open-label, multicenter, active-controlled, parallel-group clinical trial
      designed to evaluate the safety and efficacy of two doses of Bucillamine compared with
      low-dose Colchicine in the treatment of patients with acute gout flare.
    

Detailed description: 
      To evaluate the safety and tolerability of two regimens of Bucillamine 100 mg (900 mg and
      1,800 mg) over seven days of treatment compared with Colchicine 0.6 mg (1.8 mg) in the
      treatment of patients with acute gout flare
    

Intervention name(s): Bucillamine; Colchicine
Intervention type(s): Drug; Drug
Intervention description(s): Bucillamine Tablets
Intervention MeSH terms: Bucillamine; Colchicine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Trial to Evaluate the Safety and Pharmacokinetics of YHP1903 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, single dose, crossover clinical trial to evaluate the safety and
      pharmacokinetics of YHP1903 in healthy volunteers
    

Detailed description: 
      32 healthy subjects wil be randomized one of 2 groups in the same ratio. Subjects in group 1
      will be administered "comparator" and "YHP1903" by cross-over design on day1, 8.

      Subjects in group 2 will be administered "YHP1903" and "comparator" by cross-over design on
      day1, 8.
    

Intervention name(s): YHP1903; Champix
Intervention type(s): Drug; Drug
Intervention description(s): YHP1903 Tab. 1mg; Comparator Champix Tab. 1mg
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics
An Evaluation of Neurofeedback Efficacy in Adults With ADHD
Condition: ADHD
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the effectiveness of neurofeedback
      training (NFB) on objective measurements of attention in young adults with ADHD. The
      secondary objectives are to evaluate neurofeedback effects on self-report measures of
      attention, ADHD symptoms, and to identify electroencephalogram (EEG) markers of ADHD and
      neurofeedback efficacy. The study is a double-blind, placebo controlled clinical trial to
      test the efficacy and safety of EEG neurofeedback in individuals 18-40 years of age with
      attention deficit hyperactivity disorder (ADHD). Attention will be evaluated at baseline,
      after 12 and 24 training sessions (an average of 4 and 8 weeks, respectively), and 4 weeks
      after the last neurofeedback session. The primary outcome will be change from baseline on the
      Attention Performance Index (API) variable of the Test of Variables of Attention (TOVA) a
      standardized, well-normed, computerized test of attention, after 12 neurofeedback or sham
      training sessions (and average of 4 weeks). Secondary outcomes will be change from baseline
      on other TOVA variables after 12 and 24 sessions (an average of 4 and 8 weeks, respectively),
      at 4 weeks post-training follow-up, and changes from baseline at each time point on the Adult
      Self Report Scale (ASRS) and Mindful Awareness and Attention Scale (MAAS). EEG data collected
      during TOVA attention testing at baseline will be used to model EEG differences between ADHD
      and non-ADHD participants. Additional EEG data collected during the TOVA at midpoint (average
      of 4 weeks), after 24 NFB sessions (average of 8 weeks), and 4 weeks post-NFB will be used to
      develop statistical models to use as indicators of neurofeedback efficacy
    


Intervention name(s): Neurofeedback; Sham Neurofeedback
Intervention type(s): Other; Other
Intervention description(s): The intervention will be 24 sessions of beta/sensorimotor rhythm (SMR) neurofeedback.; Feedback generated by data not associated with the current participant.
Other intervention name(s): EEG biofeedback
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of N-803 on B Cell Follicles in Antiretroviral Treated HIV Disease
Condition: Hiv; HIV Infections; AIDS
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      N-803 has demonstrated ability to reactivate HIV from latency and can activate T cells and NK
      cells to clear those cells, thus reducing the reservoir. However, a concern is that CD8 T
      cells may be excluded from the B cell follicles, where a significant part of the reservoir
      resides. Webb, et al, has shown that in SIV infected monkeys CD8 T cells in follicles
      increase in frequency when N-803 is administered. We hypothesize that in HIV infected humans
      treated with N-803 that CD8 T cells will increase in B cell follicles and that there will be
      a further reduction in the frequency of cells with an inducible provirus.
    

Detailed description: 
      A phase 1B single arm study of 10 HIV-infected adults on effective ART will be performed.
      This is a two-center, non-randomized, open label, and uncontrolled study.

      All participants will undergo an extensive baseline evaluation 7-14 days before the first
      dose that will include an excisional biopsy of a lymph node, colonic biopsies, and
      leukapheresis. Participants will then receive three doses of N-803 administered every 21
      days. A second excisional biopsy will be performed between 7-14 days after the final dose.
      The study drug N-803 will be administered at 6 mcg/kg, which is the maximum tolerated dose
      determined in a recently completed dose-escalation study.
    

Intervention name(s): N-803
Intervention type(s): Biological
Intervention description(s): N-803, provided by ImmunityBio., Inc. will be administered subcutaneously at a dose 6 mcg/kg on Days 0, 21, and 42 (with a dosing window of up to 14 days post the planned dosing day)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Atomoxetine Plus Either Comparator or Placebo in Children With ADHD Who Haven't Responded to Stimulant Therapy
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of atomoxetine alone
      versus atomoxetine plus low-dose, sustained-release MPH in children with treatment-resistant
      ADHD.
    


Intervention name(s): Atomoxetine Hydrochloride; Methylphenidate Hydrochloride; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Methylphenidate; Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Nutrients to Enhance Sleep Quality and Quantity
Condition: Sleepiness in Athletes
MeSH terms: Sleepiness
Study type: Interventional

Summary: 
      Identifying non-pharmacological means of enhancing sleep is an important area of research for
      elite athletes. Research completed at the AIS has identified that some athletes have
      difficulties falling and staying asleep during both training and competition.

      There are a number of dietary components such as nutrients and certain dietary supplements
      that are purported to decrease sleep latency and increase quality of sleep. While many of
      these interventions have been investigated in isolation, no research has examined different
      combinations and/or amounts of these substances to determine the resultant effects on sleep.
      The results of such a systematic investigation could produce an effective diet based sleep
      product ("Sleep Drink').

      The optimal components, amounts, and timing of intake of such a Sleep Drink will be explored.
      Additionally, the effects on sleep will be evaluated using the gold standard of sleep
      measurement: polysomnography.
    


Intervention name(s): Tryptophan
Intervention type(s): Other
Intervention description(s): Beverage including tryptophan
Intervention MeSH terms: Tryptophan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Prevalence and Long-term Impact of Non-atherosclerotic CAD
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      Despite a relatively high prevalence of non-atherosclerotic coronary artery disease (NACAD)
      among young women, the majority of these abnormalities were misdiagnosed in this population,
      and thus treatments were not targeted adequately in this patient population. Furthermore, the
      short and long-term cardiovascular outcomes of young women with NACAD have not been
      evaluated. Given the importance of NACAD in young women, the challenges of diagnosis and
      subsequent treatment, and unknown outcomes with NACAD, we propose a prospective registry to
      further evaluate this population. We propose to evaluate young women (age < or equal to 55)
      presenting with myocardial infarction (MI) prospectively, to diagnose the etiology of MI
      differentiating atherosclerotic versus NACAD, to correlate the prevalence of FMD in other
      vascular territory, and to evaluate the long-term outcome of young women with NACAD in
      comparison to those with atherosclerotic CAD over a 5-year follow-up.
    

Detailed description: 
      All women aged 55 or younger having a coronary angiogram for acute coronary syndrome (ACS)
      will be approached prior to their procedure. A pregnancy test will be performed (standard for
      pre-menopausal women due to potential radiation exposure). If the cause of the heart attack
      is uncertain (eg no obvious infarct-related narrowing or occlusion), intravascular ultrasound
      or optimal coherence tomography will be performed within the context of the angiogram to
      better view the artery wall. A picture of the iliac and renal arteries will be accomplished
      by aortography (one dye shot down the aorta); in the case that the renal arteries are not
      well visualized, selective renal angiography will be performed (catheter at the entry to the
      renal artery). In the case of suspected non-atherosclerotic abnormalities, a head CT
      angiogram wil be performed. Referral to appropriate specialists for detected abnormality will
      occur. If symptoms continue, the subject will be followed by a cardiologist. A research
      coordinator will contact the subject at 1, 6 and 12 months and then annually to collect data
      on medications, hospitalization and symptoms.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women aged 55 or younger with a troponin positive acute coronary syndrome (ST and non-ST
        elevation myocardial infarction or Acute Coronary Syndrome (ACS)) having a coronary
        angiogram

        Negative pregnancy test
      
Keywords: myocardial infarction; dissection; coronary Fibromuscular Dysplasia; coronary ectasia; atherosclerotic Coronary Artery Disease; coronary vasculitis; coronary embolism; congenital coronary anomaly
The Effect of Parenteral Nutrition Supplement on Esophagectomy Patients
Condition: Esophagus Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional

Summary: 
      Malnutrition is common in esophagus cancer patients, especially after surgery therapy.
      Whether parenteral supplement with enteral nutrtion is benificial for patients after
      esophagectomy is controversial, when compared with enteral nutrition alone. In this study,
      the investigators are to examine the effect of enteral nutrition supplemented with parenteral
      nutrtion on nutrition status after esophagectomy.
    


Intervention name(s): Parenteral supplement with enteral nutrition for patients after esophagectomy; Enteral Nutrition alone for patients after esophagectomy
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: malnutrition; parenteral supplement; rest metabolic rate; postoperative complications
Purified Rabies Vaccine for Human Use (Chick-embryo Cell)
Condition: Rabies Post-exposure Prophylaxis
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate the immunogenicity and safety of rabies vaccine given in a post-exposure prophylaxis
      regimen to healthy children and adults aged 10-60 years.
    


Intervention name(s): rabies vaccine
Intervention type(s): Biological
Intervention description(s): Administration of PCECV according to ESSEN regimen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: rabies; vaccine; post-exposure prophylaxis