bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Patients With Periorbital Hyperpigmentation
Condition: Periorbital Hypermelanosis
MeSH terms: Hyperpigmentation
Study type: Interventional

Summary: 
      Periorbital hyperpigmentation (POH) is a common condition in dermatology practice.
      Periorbital hyperpigmentation is defined as bilateral, round, homogeneous pigmented
      macules.The etiology of POH is multifactorial including genetic and enviromental factors.
      Many treatment options are avaiblabe with variable efficacy and safety in different patients.
      Therefore, the investigator's study aims to evaluate the efficacy and safety of combined
      microneedling with topical Glutathione versus Carboxy Therapy in treatment of patients with
      periorbital hyperpigmentation.
    

Detailed description: 
      Periorbital hyperpigmentation (POH) is a common skin condition which has a great negative
      effect on the patient quality of life. Many factors contribute in the pathogensis of POH
      which lead to developement of several treatment options with no treatment option has a great
      sucess in improving the POH and patient quality of life. Our current study tries to explore
      the efficacy and safety between 2 treatment methods in a split face study.

      Microneedling is a process of making small punctres into the skin through small needles by
      device which is called a Dermapen. This microneedling method is beleived to be associated
      with improving the skin quality through increased collagen. This microneedling will be
      followed by topical application of glutathione which is a commong antioxidant with whitening
      effects.

      Carboxy therapy is a new emerging treatment option in many dermatological diseases. It will
      be used in POH patients as it will be able to increase blood flow in periorbital area and
      improve the skin qulaity.
    

Intervention name(s): carboxy therapy; Dermapen with topical glutathione
Intervention type(s): Device; Device
Intervention description(s): 6 sessions of carboxy therapy every 2 weeks; 6 sessions of Dermapen microneedling with topical glutathione every 2 weeks
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Patients with periorbital hyperpigmentation will be treated using Carboxy theraby method at right side of face followed by microneedling using dermapen will be at left side of face.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Periorbital hypermelanosis; Carboxy therapy; Microneedling; Topical Glutathione
Dexmedetomidine Versus Fentanyl for Sedation of Postoperative Mechanically Ventilated Neonates
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      Newborn infants experience pain after surgical procedures,prevention and management of pain
      in neonates is important due to its deleterious consequences. Fentanyl is a widely used
      analgesic which promotes rapid analgesia,however, is not free of adverse effects including
      chest wall rigidity, hypothermia, hypotension, respiratory depression and
      tolerance.Dexmedetomidine is a selective α 2-adrenergic agonist can cause sedation,
      anxiolysis, analgesia and minimal respiratory depression.Therefore, the objective of the
      study is to evaluate the safety and efficacy of dexmedetomidine compared to fentanyl in
      postoperative mechanically ventilated neonates.
    

Detailed description: 
      A prospective, randomized trial, which was conducted upon neonates who needed postoperative
      mechanical ventilation in Neonatal Intensive Care Unit, Mansoura University Children's
      Hospital.The patients were randomized to two groups according to the drug they received for
      postoperative sedation. The first group received dexmedetomidine infusion and the second
      group received fentanyl infusion.Our primary outcome was the efficacy of postoperative
      sedation score, and the secondary outcomes were plasma cortisol level, time to extubation,
      time to reach 100ml/kg enteral feed, need for adjuvant sedative and skeletal muscle relaxant,
      length of the hospital stay, side effects of sedative drugs and mortality.
    

Intervention name(s): Dexmedetomidine; Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): Infants received dexmedetomidine IV loading dose: 0.5 mcg/kg given over 20 minutes followed by maintenance dose 0.3 µg/kg/hour by infusion over 24 hours.Weaning was done when the patient was about to be extubated or with maximum 5 days after the randomization.; Infants received Fentanyl IV continuous infusion: 1µg/ kg /hour. Weaning was done when the patient was about to be extubated or with maximum 5 days after the randomization.
Intervention MeSH terms: Fentanyl; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess the Efficacy and Safety of CMK389 in Patients With Moderate to Severe Atopic Dermatitis.
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this phase 2 study is to assess the efficacy and safety of CMK389 in
      patients with atopic dermatitis.
    


Intervention name(s): CMK389; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Active; Placebo Comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Atopic Dermatitis; Safety; Efficacy; Atopic Eczema; Eczema; CMK389
Comparative Safety and Efficacy of Two Treatments in the Treatment of Acne Vulgaris
Condition: Acne
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the safety and efficacy of Perrigo's product to an
      FDA approved product for the treatment acne vulgaris
    


Intervention name(s): Clindamycin and Benzoyl Peroxide Gel (combination); Clindamycin and Benzoyl Peroxide Gel (Reference) (combination); Placebo gel (combination)
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
This Study is Done in Healthy Chinese and Japanese Volunteers; it Looks at How BI 690517 is Taken up in the Body and How Well it is Tolerated
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the safety and tolerability of BI
      690517 in healthy Chinese and Japanese male subjects following oral administration of single
      doses.

      Secondary objectives are the exploration of the pharmacokinetics (PK) including dose
      proportionality as well as the investigation of pharmacodynamic effects following single
      rising doses of BI 690517.
    


Intervention name(s): BI 690517; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single dose; single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Tuberculosis Volatile Organic Compounds
Condition: Pulmonary Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Observational

Summary: 
      The Pulmonary Colonization Test is a non-invasive breath test for markers of lower
      respiratory tract infection, which may predict the probability of mycobacterial organisms in
      the lower respiratory tract. It consists of:

        -  A breath collection apparatus for collection of volatile organic compounds in breath
           onto a sorbent trap and Tedlar bag, as well as for the collection of a separate sample
           of room air.

        -  Analysis of the volatile organic compounds in breath and room air by short acoustic
           wave/gas chromatography.

        -  Interpretation of the volatile organic compounds with a proprietary algorithm in order
           to predict the probability of lower respiratory tract colonization and infection.

        -  Analysis of the volatile organic compounds in sputum culture by short acoustic wave/gas
           chromatography.

      This study will test the hypothesis that the investigators can identify the presence of
      mycobacteria in an individual by sampling the breath of patients with active tuberculosis and
      by sampling "head space" above culture media of sputum provided. This study will test the
      hypotheses:

        -  that the investigators can identify positive cultures for mycobacterium tuberculosis
           through sampling of the headspace above the cultures prior to standard laboratory
           culture identification

        -  that the investigators can identify control of tuberculosis by sampling exhaled breath
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Tuberculosis patients will be enrolled through the Tuberculosis Specialty Clinic in Oxnard,
        Ca.
      
Keywords: Mycobacterium tuberculosis; Pulmonary tuberculosis; Electronic nose; Gas chromatography
The Potential for Pomegranate Juice to Ameliorate Endothelial Dysfunction
Condition: Healthy
Study type: Interventional

Summary: 
      This study will be a randomized, double-blind, crossover intervention to investigate the
      health effects of acute ingestion of pomegranate juice when consumed with a high fat meal.
      After one week of controlled dietary intervention, subjects will consume a high fat morning
      meal supplemented with either pomegranate juice or a juice-free sweetened beverage. After
      consumption of the breakfast meal, subjects will be assessed for endothelial function and
      postprandial meal response.
    


Intervention name(s): Controlled diet
Intervention type(s): Other
Intervention description(s): 1 week of controlled diet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effect of Spirulina on Periodontitis
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      The purpose of this study is to assess the clinical and immunological effect of spirulina in
      treatment of stage II periodontitis.
    

Detailed description: 
      In this study, the investigators tested the effect of spirulina gel as adjunctive of scaling
      and root planing in treatment of stage II, grade B periodontitis in term of probing pocket
      depth reduction, mean gain in clinical attachment level, and level of interleukin 6.
    

Intervention name(s): spirulina gel; SRP of all teeth
Intervention type(s): Drug; Procedure
Intervention description(s): Patient were received spirulina gel in diseased sites. The process will be repeated at 7, 14, 21 days.; Patients received oral hygiene instructions and SRP of all teeth.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
High-Intensity, Brief-Duration Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphocytic Leukemia
Condition: Leukemia
MeSH terms: Leukemia
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of high-intensity, brief-duration
      chemotherapy in treating patients with relapsed or refractory acute lymphocytic leukemia.
    

Detailed description: 
      OBJECTIVES: I. Determine the complete response rate to high-intensity, brief-duration
      chemotherapy with cyclophosphamide, methotrexate, vincristine, doxorubicin, and dexamethasone
      followed by ifosfamide, methotrexate, vincristine, cytarabine, etoposide, and dexamethasone
      in patients with relapsed or refractory acute lymphocytic leukemia (ALL). II. Determine the
      toxic effects of these regimens in these patients.

      OUTLINE: All patients receive up to six alternating courses (every 3-4 weeks) of two
      chemotherapy regimens: cyclophosphamide, oral dexamethasone, methotrexate with leucovorin
      rescue, vincristine, and doxorubicin over 5 days; and ifosfamide/mesna, oral dexamethasone,
      methotrexate with leucovorin rescue, vincristine, cytarabine, and etoposide over 5 days.
      G-CSF is given following each course until recovery of the neutrophil count. All patients
      receive triple intrathecal chemotherapy on day 1. Patients with CNS disease receive
      intrathecal therapy twice weekly until the CSF is clear, then weekly for 4 weeks, and monthly
      for 1 year; those who have not received prior CNS irradiation also receive whole-brain
      radiotherapy. Patients are followed monthly for 6 months, every 3 months for 18 months, every
      6 months for 2 years, then annually.

      PROJECTED ACCRUAL: A total of 37 evaluable patients will be accrued if at least 4 of the
      first 17 patients respond.
    

Intervention name(s): filgrastim; cyclophosphamide; cytarabine; dexamethasone; doxorubicin hydrochloride; etoposide; ifosfamide; leucovorin calcium; mesna; methotrexate; therapeutic hydrocortisone; vincristine sulfate; low-LET cobalt-60 gamma ray therapy; low-LET photon therapy
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Radiation; Radiation
Intervention MeSH terms: Leucovorin; Cobalt; Cytarabine; Dexamethasone; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Cyclophosphamide; Ifosfamide; Doxorubicin; Liposomal doxorubicin; Methotrexate; Etoposide; Vincristine; Levoleucovorin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent adult acute lymphoblastic leukemia
Safety of Juvista When Administered Following Excision of Ear Lobe Keloids
Condition: Keloid
MeSH terms: Keloid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This trial will assess the safety and efficacy of 500ng Juvista per linear cm of wound margin
      administered by intradermal injection following the excision of keloid scars on the ear lobe.
      Ear lobe keloids commonly occur after ear piercing and can be particularly distressing for
      patients as they are very difficult to conceal and are usually bilateral. As the recurrence
      rate and growth rate of keloids can vary significantly between individuals, trial subjects
      will have bilateral ear lobe keloids and will act as their own control. One ear lobe will be
      treated with Juvista following keloid excision and one with placebo.
    


Intervention name(s): Avotermin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 patients undergoing surgical revision of bilateral keloids will be dosed with 500ng Juvista/100µL per cm of wound margin to one ear lobe and placebo to the other and followed up for three months after dosing to assess the local and systemic tolerability.; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
GLP-1 Agonism for Blocking Cocaine Euphoria and Self-Administration
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators plan to explore the effects of acute pre-treatment with the glucagon like
      peptide-1 (GLP-1) agonist, exenatide versus placebo, on the subjective (e.g., euphoric) and
      behavioral effects (e.g., self-administration) of cocaine in experienced, non-treatment
      seeking users of the drug. Additionally, the investigators plan to explore the effects of
      sub-chronic (5-day) treatment with exenatide as compared to placebo on the subjective (e.g.,
      euphoric) and behavioral (self-administration) effects of cocaine in experienced,
      non-treatment seeking users of the drug.
    


Intervention name(s): cocaine hydrochloride; exenatide; placebo
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): byetta
Intervention MeSH terms: Exenatide; Cocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Comparison Between the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA) for Robotic Thyroidectomy
Condition: Thyroid Papillary Carcinoma; Thyroidectomy
MeSH terms: Carcinoma, Papillary; Thyroid Cancer, Papillary
Study type: Interventional

Summary: 
      The purpose of this study is to compare the therapeutic effects between the axillary
      bilateral-breast approach (ABBA) and bilateral axillo-breast approach (BABA) for robotic
      thyroidectomy.To explore the efficacy, safety, cosmetic results and clinical value by the two
      approaches.
    

Detailed description: 
      Although several reports on operative outcomes of the robotic technique have appeared, no
      prospective trials comparing the clinical results of between the axillary bilateral-breast
      approach (ABBA) and bilateral axillo-breast approach (BABA) for robotic thyroidectomy have
      been described. The investigators therefore designed a prospective trial comparing outcomes,
      including surgical outcomes and patient satisfaction, between patients undergoing robotic and
      conventional open thyroidectomy.
    

Intervention name(s): The Axillary Bilateral-breast Approach; The bilateral Axillo-breast Approach
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Robotic thyroidectomy; Robotic central neck dissection; Axillary bilateral-breast approach; Bilateral axillo-breast approach
Tube 1st Technique for Easy Fiberoptic Intubation
Condition: Difficult Intubation
Study type: Interventional

Summary: 
      the aim of this work is to study how this technique will make nasal fiberoptic intubation
      easier and faster than the usual classic technique
    

Detailed description: 
      Difficult intubation is one of the most significant issues anesthesiologists deal with,
      occasionally. Among these, mandibulofacial deformities face the biggest challenge in
      intubation and make an anticipated difficult airway (1), due to short length of mandible
      (HLM), short thyromental distance (TMD), short inter horizontal -incisors gap (IIG) and high
      grade modified Mallampati test (MMT) (2).

      There are several strategies to approach these patients and each technique has unique
      benefits that should be used on experience. Sitting endotracheal intubation is a useful
      technique for airway control, in patients with difficult airway or in patients in whom
      maintenance of the upright posture is beneficial (3), A difficult airway is defined as
      difficulty with facemask ventilation, difficulty with tracheal intubation, or both (3).
      According to new updates on difficult airway management, by the American Society of
      Anesthesiologists, there are non-invasive and invasive interventions for the management of
      difficult airway. Non-invasive interventions include, without being limited to: awake
      intubation, video-assisted laryngoscopy, intubating stylets or tube-changers, supraglottic
      airway (SGA) for ventilation (e.g., LMA, laryngeal tube), SGA for intubation (e.g., ILMA),
      rigid laryngoscopic blades of variousdesign and size, fiberoptic-guided intubation, and
      lighted stylets or light wands, while invasive interventions include surgical or percutaneous
      airway, jet ventilation and retrograde intubation (4).

      Attaching a nasal airway to a breathing circuit as a tool to assist or control ventilation is
      a very helpful trick to have in challenging airway management situations.

      Typically, Fiberoptic bronchoscope is passed through the more patent nostril to follow the
      major nasal pathway at the floor of the nose along the superior aspect of the hard palate,
      the lateral aspect of the nasal septum inferior to the lower turbinate to reach the
      nasopharynx where the operator identifies the pharyngeal structures, such as the base of the
      tongue and/or the epiglottis that are mostly "in-fall" precluding clear views of the larynx
      requiring a jaw thrust to visualize the laryngeal structures for patients planned to be
      intubated under general anesthesia [5,6].
    

Intervention name(s): fiberoptic intubation classic technique; fiberoptic intubation tube 1st technique
Intervention type(s): Other; Other
Intervention description(s): classic fiberoptic intubation; tube 1st technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
A Pharmacokinetic Study of [14C]-GDC-0810 After Single Oral Administration in Healthy Female Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, non-randomized study to determine the excretion kinetics and mass
      balance of GDC-0810, and to determine metabolites present in blood, feces, and urine in
      healthy participants following a single 300-milligram (mg) oral dose of GDC-0810 containing
      approximately 100 microcuries of [14C] labeled GDC-0810 using conventional absorption,
      metabolism, and excretion (AME) methodology. The entire duration of the study is up to
      approximately 8 weeks.
    


Intervention name(s): [14C]-GDC-0810
Intervention type(s): Drug
Intervention description(s): Participants will receive a single 300-mg dose of GDC-0810 containing approximately 100 microcuries of [14C]-labeled GDC-0810 on Day 1.
Other intervention name(s): ARN-810; RO7056118
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety and Pharmacokinetic Effects of Oseltamivir Alone or in Combination With Amantadine
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess the safety and pharmacokinetic effects of oseltamivir
      administration alone or in combination with amantadine in healthy volunteers.
    


Intervention name(s): amantadine hydrochloride; oseltamivir phosphate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Oseltamivir; Amantadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oseltamivir, amantidine, Symmetrel, Tamiflu