bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics and Safety/Tolerability of CKD-379
Condition: Type II Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to compare the pharmacokinetics and safety/tolerability between CKD-379 tablet and
      D759, D745, D150 combination
    

Detailed description: 
      A randomized, open-label, single dose, 2-period, 2-treatment, crossover study to compare the
      pharmacokinetics and safety/tolerability of CKD-379 in healthy subjects under fed conditions
    

Intervention name(s): CKD-379; D759+D745+D150
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet administration under fed condition; 3 tablet coadministration under fed condition
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Correlation Between Dorsalis Pedis and Radial Arterial Invasive Blood Pressures During Anesthesia Induction in Neurosurgical Patients
Condition: Blood Pressure
Study type: Interventional

Summary: 
      Anesthesiologists need to understand the specific difference between dorsalis pedis
      arterial(DPA) pressure and the more commonly used radial arterial(RA) pressure When blood
      pressure monitoring at DPA. Generally, the systolic blood pressure measured in DPA is
      significantly higher than that in RA, with little difference of diastolic blood pressure and
      mean artery pressure in two sites. However, there is no specific study on the difference
      between them, and it is not clear how the diagnosis and treatment threshold should be
      adjusted when relying on DPA blood pressure measurement to guide treatment. The
      intraoperative blood pressure of patients is in the normal range in most cases. The purpose
      of this study is to analyze the correlation of different blood pressure stratification
      (RASBP90-109mmHg,110-129mmHg,130-149mmHg) of DPA-RA in the normal range to understand the
      correlation of DPA-RA in different blood pressure ranges, to provide a reference for clinical
      decision-making and hemodynamic management.
    


Intervention name(s): invasive blood pressure monitoring
Intervention type(s): Diagnostic Test
Intervention description(s): radial artery and dorsalis pedis artery intubated with BD Insyte-W 22G artery puncture needle under local anaesthesia
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: correlation radial artery dorsalis pedis artery
Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to demonstrate the antihypertensive efficacy of once daily oral
      administration of ACT 280778 on DBP compared to placebo after 28 days.
    


Intervention name(s): ACT-280778; Placebo; Amlodipine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 mg once daily for 28 ± 2 days; Placebo oral capsules matching ACT-280778; 10 mg once daily for 28 ± 2 days
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Impact of the Opiate Antagonist Naltrexone on the Emotional Valence of Dreams
Condition: Neuroscience of Dreaming, Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, the investigators pose the question which influence the opioid circuit has on
      positive valent situations in dreams.
    


Intervention name(s): Naltrexone; Placebo
Intervention type(s): Drug; Other
Intervention description(s): one week; one week
Other intervention name(s): Naltrexin; Placebo Pills
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Psychology; Dreams
Safety Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects 65 to 75 Years of Age
Condition: Moderate to Severe Convexity of Submental Fat; Safety; Efficacy
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study are to explore the safety and efficacy of subcutaneous
      injections of Deoxycholic Acid relative to placebo, in the submental area of participants who
      are 65 to 75 years old.
    


Intervention name(s): ATX-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.; Phosphate buffered saline placebo for injection
Other intervention name(s): deoxycholic acid
Intervention MeSH terms: Deoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
High Resolution IR Imaging for Diagnosis in the Acute Limping Child - ThermLimp
Condition: Limping
Study type: Interventional

Summary: 
      A variety of different diseases may cause a limp in a child, and in younger children it is
      particularly challenging to isolate the area affected. Children of this age group are unable
      to identify a specific region of pain, so clinical examination and parental interpretation is
      the only method of localising the area of discomfort. Potential problems that may affect
      children include inflammation, fractures, infection, juvenile arthritis or movement in the
      growth plate in the hip, among other diseases. Aside from an obvious source of injury, it is
      challenging for a clinician to distinguish between these different potential causes or the
      area of the problem without repeated visits, non-specific blood tests and the use of x-ray
      imaging: a form of radiation that carries with it a small risk of carcinogenic effect. Once a
      region of the lower limb is identified, an x-ray image of the affected area is often taken;
      however, it is not possible to image the entire leg, so the importance of the initial
      examination by a clinician is evident. The aim of this research project is to assess the
      potential of high resolution infrared (IR) imaging technology in the identification of a
      focus for the cause of a limping child. The IR camera used for imaging is able to observe an
      entire limb, so the need to localise an area for imaging would be removed. In addition, if
      successful, infrared imaging could reduce the number of children exposed to x-ray radiation
      unnecessarily, whilst stream-lining medical practice by reducing the time to make a diagnosis
      along with unnecessary visits and tests. The investigators aim to explore whether
      non-invasive IR thermographic camera imaging assists with the clinical diagnosis in children
      presenting with an acute limp. This study represents a pilot evaluation as a test of concept.
    


Intervention name(s): Infrared imaging
Intervention type(s): Device
Intervention description(s): Infrared image image acquisition of study participants
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Genz-682452 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess in healthy adult subjects:

        -  The tolerability and safety of ascending repeated oral doses of Genz-682452.

        -  The pharmacokinetic parameters of Genz-682452 after ascending repeated oral doses.

        -  The pharmacodynamics of Genz-682452 after ascending repeated oral doses.
    


Intervention name(s): Genz-682452; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Capsules for oral administration.; Placebo capsules matching the Genz-682452 capsules.
Intervention MeSH terms: Venglustat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Employment-based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction. - 2
Condition: Behavior, Addictive; Cocaine Abuse; Cocaine Dependence; Heroin Dependence; Opioid Dependence
MeSH terms: Cocaine-Related Disorders; Opioid-Related Disorders; Heroin Dependence; Behavior, Addictive
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether long-term exposure to the Therapeutic
      Workplace intervention could sustain drug abstinence over an extended period of time in
      heroin- and cocaine-dependent, unemployed, treatment-resistant young mothers.
    

Detailed description: 
      The current study is a continuation of the research into the development and evaluation of a
      novel treatment designed to address the chronic, persistent nature of drug addiction. This
      treatment, called the Therapeutic Workplace, integrates abstinence reinforcement
      contingencies of proven efficacy into a model supported work program. Participants were paid
      to work or to train in the Therapeutic Workplace but had to provide drug-free urine samples
      to gain daily access. Forty participants were randomly assigned to a Therapeutic Workplace or
      usual care control group. Therapeutic Workplace participants could work for about 5 years.
      This study reports the effects of the intervention over a follow-up period of 8 years after
      treatment initiation.
    

Intervention name(s): Contingency management
Intervention type(s): Behavioral
Intervention description(s): Invited to attend the Therapeutic Workplace 3 hr per day, Monday through Friday. Each day when a participant reported to the workplace, she was required to provide a urine sample. If the sample tested negative for opiates and cocaine, she was allowed to work that day. Participants who gained entrance to the workplace participated in basic skills education and job skills training throughout each 3-hr work shift.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Behavior Therapy; Cocaine Abuse; Cocaine Dependence; Contingency Management; Heroin Dependence; Methadone; Opioid Dependence
A Phase I Clinical Trial of an HPV Therapeutic Vaccine
Condition: Human Papillomavirus
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will consist of 300 women aged 18-50 years. The study will show that a new
      therapeutic human papillomavirus (HPV) vaccine designed to regress a precancerous condition
      called high-grade squamous intraepithelial neoplasia (HSIL)is safe. HPV is known to cause
      cervical, vaginal, oral, and anal cancers. This novel vaccine will consist of a synthetically
      made fragment of HPV protein called E6 and yeast extract called Candin®. Previous studies
      have revealed that immune response to E6 is important in fighting HPV. We also know that
      injecting Candin has anti-HPV effect since it has been used to treat common warts which are
      caused by different types of HPV. The current standard treatment for HSIL is loop electrical
      excision procedure (LEEP). The immune system is the part of the body that fights infection
      and cancer. This research study will also examine the immune response to the vaccine and its
      effectiveness in regressing HSIL. Volunteers would be eligible to enroll in the study if they
      have had a recent Papanicolaou (Pap) smear result indicating HSIL or "Cannot rule out HSIL",
      and if they meet the inclusion/exclusion criteria. Subjects will be eligible to receive
      vaccinations if biopsy confirms HSIL. A series of four vaccinations will be given roughly 3
      weeks apart, and LEEP will be performed at the end of the study approximately 12 weeks after
      the last vaccination.
    


Intervention name(s): Vaccine consisting of four HPV-16 E6 peptides in combination with Candin®
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: human papillomavirus (HPV); vaccine; treatment
Tadalafil for Erectile Dysfunction in Patients With Cirrhosis
Condition: Cirrhosis
MeSH terms: Liver Cirrhosis; Erectile Dysfunction; Fibrosis
Study type: Interventional

Summary: 
      This study will be conducted into two parts 1) Screening of 400 cases of cirrhosis (Child
      A,child B and child c) for the prevalence and risk factors of erectile dysfunction in
      cirrhosis.2) The part 2 is RCT as follows where 70 cases in each arm will be taken wuth child
      A and child B cirrhosis for the effect of treatment on erectile dysfunction (Tadalafil vs
      Placebo).

      After getting informed consent. Clinical, anthropometric and biochemical assessment will be
      done by candidate, co-supervisors and supervisor. Screening and selection criteria by using
      various questionnaire like Karnofsky Performance Score (KPS) , IIEF Questionnaire , ADAMS
      Questionnaire, Generalized Anxiety Disorder 7 (GAD-7) questionnaire, Patient Health
      Questionnaire (PHQ-9 for depression ; and SF-36 questionnaire).

      The informed consent will be obtained from the participants in the study. Patients-ED IIEF<25
      will be included as per inclusion and exclusion criteria. Tadalfil regimen: 10 mg daily at
      any time before anticipated sexual activity on days with anticipated sexual activity On days
      with no anticipated sexual activity: 10 mg daily at night after meals. Follow-up1 week,
      2weeks, 4weeks, 12 weeks with history, clinical examination and laboratory test.
    


Intervention name(s): Tadalafil 10 MG; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Tadalafil 10 mg per oral once daily for 3 months; TPlacebo tablet per oral once daily for 3 months
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Topical Lidocaine for Pain Control With Intrauterine Device (IUD) Insertion
Condition: Pain
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Intrauterine contraception is a very effective, long term, reversible form of birth control,
      and is increasingly used in young, nulliparous patients. However, there is potential for pain
      with insertion of an Intrauterine Device (IUD) - particularly in patients without a previous
      history of vaginal delivery. The potential pain associated with insertion is often a
      significant barrier for patients when choosing and IUD for contraception. Several methods of
      pain control have been studied, but none have been shown to reduce pain at time of insertion.
      Our research question is to determine if 2% topical lidocaine gel, instilled into the
      cervical canal, will reduce maximum pain at time of insertion of a popular IUD (Mirena
      Intrauterine System) in young, nulliparous patients. This will be studied in a randomized,
      double-blind placebo-controlled trial.
    

Detailed description: 
      The investigators research question is to determine if 2% topical lidocaine gel, instilled
      into the cervical canal, will reduce maximum pain at time of insertion of a popular IUD
      (Mirena Intrauterine System) in young, nulliparous patients. This will be studied in a
      randomized, double-blind placebo-controlled trial.
    

Intervention name(s): Lidocaine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): During the procedure (placement of the IUD), 1ml of gel will be applied to the anterior lip of the cervix. After 1 minute of waiting, a tenaculum will be placed to steady the cervix. The catheter will be introduced into the cervical canal, past the external os and 1-1.5ml of gel will be placed into the canal. After another minute, the IUD will be placed in the standard fashion.; Placebo; no topical lidocaine administered
Other intervention name(s): No intervention
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Intrauterine Device
VNS-supplemented Motor Retraining After Stroke
Condition: Stroke, Acute
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The goal of this study is to learn more about the connections between the brain, spinal cord,
      and muscles and how these connections can be strengthened after neurological injury.
    

Detailed description: 
      To establish a link between the physiological mechanisms driving enhanced motor control in
      response to VNS, subjects will undergo progressive training on a visuomotor task that
      requires fine gradation of voluntary motor output to control a moving object through target
      boundaries. In separate groups, VNS or sham stimulation will be paired with movement when a
      minimal time-on-target (ToT) is achieved.
    

Intervention name(s): Training; Vagus Nerve Stimulation; Sham Stimulation
Intervention type(s): Other; Other; Other
Intervention description(s): Controlling movement of an object on computer screen by adjusting muscle activity.; Recruits the auricular branch of the vagus nerve which activates brain structures that release chemicals mediating cortical plasticity.; Sub-threshold stimulation that does not activate neural structures.
Other intervention name(s): VNS; Sham
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Evaluation of the Safety and Pharmacokinetics of Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Combination Ophthalmic Solution
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Study type: Observational

Summary: 
      To compare the safety and tolerability of brimonidine tartrate 0.025%/ketotifen fumarate
      0.035% combination ophthalmic solution versus its vehicle in healthy adult subjects and in
      pediatric subjects.
    

Detailed description: 
      The study will consist of 4-51 study visits to compare the safety and tolerability of
      brimonidine tartrate 0.025%/ketotifen fumarate 0.035% combination ophthalmic solution versus
      its vehicle in healthy adult subjects and in pediatric subjects with a history or family
      history of atopic disease (including allergic conjunctivitis).

      To characterize the plasma pharmacokinetics (PK) of brimonidine tartrate 0.025%/ketotifen
      fumarate 0.035% combination ophthalmic solution following a single dose and 22-day twice
      daily (BID) topical ocular dosing in a subset of healthy adult subjects.
    

Intervention name(s): rimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution (Combo); Vehicle of brimonidine tartrate 0.025%/ketotifen fumarate 0.035% ophthalmic solution
Intervention type(s): Drug; Drug
Intervention description(s): rimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution (Combo); Vehicle of brimonidine tartrate 0.025%/ketotifen fumarate 0.035% ophthalmic solution
Intervention MeSH terms: Ketotifen; Brimonidine Tartrate; Pharmaceutical Solutions; Ophthalmic Solutions
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Approximately 600 subjects will be screened in order to enroll approximately 501 subjects
        from approximately 6 sites in the United States. Of the subject total, approximately 100
        pediatric subjects are anticipated to be enrolled into this study.
The Effects of The Use of Baby Mobile Accompanied With Brahms Lullaby On The Infants During Sternum Dressing
Condition: Pain, Procedural (During Sternum Dressing on Infants); Physiological Parameters During Sternum Dressing in Babies
MeSH terms: Pain, Procedural
Study type: Interventional

Summary: 
      The study was conducted experimentally in a randomized controlled manner in order to
      determine the effect of the use of baby mobile accompanied by Brahms Lullaby on physiological
      parameters and pain level during sternum dressing in babies. The research was carried out
      with 76 babies followed up in the Pediatric Cardiovascular Surgery Intensive Care Unit
      between August 2020 and February 2021 (Baby Mobile Group accompanied by Brahms Lullaby: 38,
      Control Group: 38). Data were collected by using the "Baby Monitoring Form" and "FLACC Pain
      Scale".
    


Intervention name(s): THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABY
Intervention type(s): Behavioral
Intervention description(s): Using of baby mobile and listening Brahms Lullaby during sternum dressing process
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled two groups ( control group and experiment group)
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Sternum Dressing; Infant; Brahms Lullaby; Baby Mobile; Pain; Physiological Parameters
Bevacizumab and Chemoembolization in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different
      ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
      help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the
      growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Chemoembolization kills tumor cells by carrying chemotherapy drugs
      directly into the tumor and blocking the blood flow to the tumor. Giving bevacizumab together
      with chemoembolization may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving bevacizumab together with
      chemoembolization works in treating patients with liver cancer that cannot be removed by
      surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Improve median progression-free survival of patients with unresectable hepatocellular
           cancer treated with bevacizumab and transarterial chemoembolization therapy.

      Secondary

        -  Characterize the safety and toxicity of this regimen in these patients.

        -  Determine the response rate in patients treated with this regimen.

      OUTLINE: Patients receive bevacizumab once in weeks 1, 3, and 5. Beginning in week 3,
      patients also receive transarterial chemoembolization (TACE) therapy. Treatment repeats
      approximately every 8 weeks for up to 3 courses. Patients achieving < 100% necrosis by MRI
      after the first course receive 2 additional courses of bevacizumab and TACE.

      PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
    

Intervention name(s): bevacizumab; chemotherapy; embolization therapy; hepatic artery infusion
Intervention type(s): Biological; Drug; Drug; Procedure
Intervention MeSH terms: Bevacizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: localized unresectable adult primary liver cancer; adult primary hepatocellular carcinoma; advanced adult primary liver cancer; recurrent adult primary liver cancer