bioihbjkbjnl/mcl2 huggingface dataset:
A Relative Bioavailability Study of Sertraline HCl 100 mg Tablets Under Non-fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the rate of absorption and oral bioavailability of a test formulation of
      Sertraline 100 mg tablets manufactured by Purepac Pharmaceutical Company to an equivalent
      oral dose of the commercially available reference product, Zoloft® manufactured by Pfizer
      Inc. Following an overnight fast of at least 10 hours, subjects will consume a standard
      high-calorie, high-fat breakfast meal. This standard breakfast will begin 30 minutes prior to
      each dose.
    

Detailed description: 
      Study Type: Interventional Study Design: A single-dose, open-label, randomized, two-period
      crossover study

      Official Title: A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of
      Sertraline 100 mg Tablets Under Fed Conditions

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      Rate and Extend of Absorption
    

Intervention name(s): Sertraline HCl 100 mg tablets, single dose; Zoloft® 100 mg tablets, single dose
Intervention type(s): Drug; Drug
Intervention description(s): A: Experimental SSubjects received Purepac formulated products under non-fasting conditions; B: Active comparator Subjects received Pfizer formulated products under non-fasting conditions
Other intervention name(s): Sertraline; Sertraline
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Sertraline; Healthy subjects
Safety and Tolerability of Preservative-free Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Healthy Subjects
Condition: Acanthamoeba Keratitis
MeSH terms: Acanthamoeba Keratitis; Keratitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, double-masked, placebo-controlled, multiple center, parallel-group Phase 1 study
      to evaluate the safety and tolerability of 3 doses of preservative-free PHMB ophthalmic
      solution compared to placebo in healthy subjects
    

Detailed description: 
      The primary objective of the study is to establish the ocular safety and tolerability, and
      systemic safety of 3 different concentrations of preservative-free PHMB in healthy subjects.
      Safety and tolerability will be compared to those of a placebo.The PHMB bioavailability in
      plasma will also be assessed
    

Intervention name(s): 0.04% PHMB; 0.06% PHMB; 0.08% PHMB; PHMB Vehicle
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days; 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days; 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days; PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
Other intervention name(s): Polyhexamethylene Biguanide; Polyhexamethylene Biguanide; Polyhexamethylene Biguanide
Intervention MeSH terms: Biguanides; Polihexanide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Diclofenac Plus Lidocaine Gel for Pain Relief During Intrauterine Device Insertion(IUD).
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to determine the effectiveness of a combination of diclofenac and
      lidocaine gel in reducing pain during IUD insertion.
    

Detailed description: 
      Various studies evaluating the use of local anesthetics or misoprostol prior to IUD insertion
      have mixed results.We think that the combination of diclofenac and lidocaine gel could be
      more successful in relieving pain during IUD insertion than single therapy.The aim of this
      study is to determine the effectiveness of a combination of diclofenac and lidocaine gel in
      reducing pain during IUD insertion.
    

Intervention name(s): Diclofenac plus lidocaine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The study nurse will instruct the patients to swallow diclofenac tablets (100 mg) 1 hour before IUD insertion. Three millilitres of the lidocaine gel will be placed on the anterior lip of the cervix . A cotton swab socked in 3 ml of the lidocaine gel will be introduced in the cervical canal till the level of internal os. The cotton swab will be left in place for three minutes. The IUD will be inserted by experienced gynecologists according to the recommendations of manufacture.; The study nurse will instruct the patients to swallow placebo tablets 1 hour before IUD insertion. Three millilitres of the placebo gel will be placed on the anterior lip of the cervix . A cotton swab socked in 3 ml of the placebo gel will be introduced in the cervical canal till the level of internal os. The cotton swab will be left in place for three minutes. The IUD will be inserted by experienced gynecologists according to the recommendations of manufacture.
Intervention MeSH terms: Diclofenac; Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: IUD,Diclofenac , Lidocaine
A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer
Condition: Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a Phase 2a trial to investigate the safety and biological activity of the RIX-2
      Regimen in patients with untreated, resectable squamous cell cancer of the head and neck
      (HNSCC).
    

Detailed description: 
      IRX-2 is a primary cell-derived biologic that reduces the immune suppression that is often
      seen in the cancer tumor micro-environment, restores immune function and activates a
      coordinated immune response against the tumor. IRX-2 is a complex proprietary therapeutic
      containing numerous active cytokine components, which restores and activates multiple immune
      cell types including T cells, dendritic cells, and natural killer cells to recognize and
      destroy tumors.

      The present study administered the IRX-2 Regimen to 27 patients as a neoadjuvant (before
      surgery) therapy, and the main objective of the study was to determine the safety and
      tolerability of the IRX-2 regimen.
    

Intervention name(s): IRX-2; Cyclophosphamide; Indomethacin; Zinc; Omeprazole
Intervention type(s): Biological; Drug; Drug; Drug; Drug
Intervention description(s): IRX-2 for 10 days (2 s.c. injections of 1 mL each day) into bilateral mastoid insertion regions.; Single i.v. injection of low-dose (300 mg/m2) on Day 1; 21 days of oral indomethacin, 25 mg. 3 times daily; 21 days of zinc gluconate (65 mg) as part of an oral multivitamin; 21 days of 20 mg. orally
Other intervention name(s): Cytoxan; cyclophosphane; Indocin; Indocid; zinc gluconate; Prilosec
Intervention MeSH terms: Zinc; Indomethacin; Cyclophosphamide; Omeprazole
Intervention model: Single Group Assignment
Intervention model description: Open Label Single Arm Phase 2a trial of Safety of IRX-2 in Patients with Operable Head and Neck Cancer
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Head and Neck Cancer; Immunotherapy; IRX-2; Mouth Cancer; Throat Cancer
A Study To Investigate The Pharmacokinetics, Safety And Tolerability Of An Intravenous And Oral Form Of A Compound In Subjects With Varying Degrees Of Renal Impairment And Normal Renal Function
Condition: Pneumonia
MeSH terms: Pneumonia; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate what effect renal dysfunction has on a drug that has an intravenous
      (CP-70,429) and an oral form (PF-03709270).
    

Detailed description: 
      To evaluate the pharmacokinetics and safety.
    

Intervention name(s): CP-70,429 and PF-03709270
Intervention type(s): Drug
Intervention description(s): Study Periods 1 and 2 will be separated by a minimum of 14 days. In Period 1, subjects will receive a single dose of CP-70429 (800 mg given as a 1.5 hour intravenous infusion), while in Period 2, subjects will receive a single oral dose of PF-03709270 (1000 mg).
Other intervention name(s): CP-70,429 - sulopenem
Intervention MeSH terms: Lactams
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Effectiveness of Neuronavigated Continuous Theta Burst Stimulation of the Left Heschl's Gyrus in Chronic Tinnitus
Condition: Chronic Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      Neuronavigated continuous theta burst stimulation of the left Heschl's gyrus is used to
      modulate auditory cortex activity and plasticity contributing to the perception and distress
      of chronic tinnitus.
    

Detailed description: 
      Tinnitus is the phantom auditory perception of sound in the absence of an external or
      internal acoustic stimulus. It is a frequent problem which can interfere significantly with
      the ability to lead a normal life. One significant modulator of tinnitus is stress. Tinnitus
      has been shown to be generated in the brain, as a result of functional reorganization of
      auditory neural pathways and the central auditory system. Repetitive transcranial magnetic
      stimulation (rTMS) is also effective in treatment of tinnitus with moderate effect size.
      Pilot data were positive for low-frequency rTMS applied to the temporal and temporoparietal
      areas. Continuous theta burst stimulation (cTBS) is a new protocol of rTMS with a possible
      superior effect in contrast to low-frequency rTMS. Also anatomical neuronavigation might
      increase the efficacy of rTMS due to exact targeting of the primary auditory cortex. Thus,
      the aim of this study is the evaluation of the clinical efficacy of neuronavigated left-sided
      cTBS in chronic tinnitus in a randomised sham-controlled two-arm design.
    

Intervention name(s): Left temporal verum cTBS; Left temporal placebo cTBS
Intervention type(s): Device; Device
Intervention description(s): Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session)
Arms: Left temporal verum cTBS; Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session); coil tilted by 45° over both wings
Arms: Left temporal placebo cTBS
Other intervention name(s): MC-B70, MagPro,MagOption, Medtronic, Germany; MC-B70, MagPro,MagOption, Medtronic, Germany
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Early Access to Virtual Resources for the Self-management of Plantar Fasciitis
Condition: Plantar Fascitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

Summary: 
      This proof of concept and feasibility study will adopt a mixed methods approach. The primary
      objectives will be to assess participants' acceptance and usability of a package of self-help
      videos for Plantar Fasciitis designed to be accessed shortly after suitable participants are
      referred to the podiatry service, and also the feasibility of conducting a future randomised
      controlled trial. The secondary objectives will be to assess the effects of the intervention
      on pain and quality of life.
    

Detailed description: 
      This proof of concept and feasibility project will investigate the use of a self-help package
      of virtual resources for the treatment of plantar fasciitis. The research will involve a
      small group of ten, shortly after participants are referred to Cardiff & Vale UHB podiatry
      service and join the waiting list.

      The virtual resources will include short videos demonstrating ways of managing symptoms, such
      as gentle stretching exercises, and footwear recommendations. Participants will be given
      access to these resources to watch at their convenience. Patient reported outcome measures
      (foot pain, and quality of life) will be collated at baseline and periodically up to 6 weeks.
      Participants' acceptability of these resources will be assessed through interviews at the end
      of the six weeks.

      The feasibility of conducting a future randomised controlled trial will be assessed by
      looking at recruitment rates, retention and any patient safety issues. It is hoped the long
      term benefit will be that participants joining the waiting list can engage with these
      resources at the earliest opportunity to help manage their symptoms.

      This research is important because it presents an opportunity to work with participants at
      the start of joining a waiting list, and the benefits of early access to virtual resources
      could be applicable to a number of different health problems.
    

Intervention name(s): Early access to virtual resources
Intervention type(s): Other
Intervention description(s): Single arm study. Participants are given access to self help videos for the management of plantar fasciitis while they are on the waiting list
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Recovery Time of Quadriceps Strength After Total Knee Arthroplasty (TKA): The Effect of Quadriceps Incision Length
Condition: Osteoarthritis of Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Minimally invasive total knee arthroplasty (MIS-TKA) became the popular technique. It had the
      less postoperative pain and shorter recovery time compared to the conventional technique.
      With using MIS technique, less cut of quadriceps tendon was the key. It related to keep more
      quadriceps strength and improve functional performance after TKA. However, there was no
      previous studies about the effect of quadriceps incision length in the recovery time of the
      quadriceps strength. The investigators hypothesized that longer quadriceps incision affected
      the longer recovery time of quadriceps strength in MIS-TKA.
    


Intervention name(s): Quadriceps incision < 2 cm; Quadriceps incision 2-4 cm; Quadriceps incision > 4 cm
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): MIS-TKA was performed with less than 2 cm Quadriceps incision length; MIS-TKA was performed with 2 to 4 cm Quadriceps incision length; MIS-TKA was performed with more than 4 cm Quadriceps incision length
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Dexmedetomidine Versus Fentanyl as an Adjuvant to Bupivacaine in Saddle Block
Condition: Regional Anesthesia Morbidity
Study type: Interventional

Summary: 
      Dexmedetomidine is recommended over fentanyl as adjunctive medication to bupivacaine for
      saddle block spinal anesthesia in anal surgeries and procedures.
    

Detailed description: 
      Objectives: A saddle spinal block is a viable choice for anal surgeries. This technique
      effectively maintains balanced hemodynamics, and fast recovery, and prevents irrelevant motor
      blocks in both limbs.

      Methods: Fifty-eight adult patients were categorized into two groups. Group FENT, consisting
      of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with
      fentanyl (0.5 ml; 25 μg). The DEX Group, consisting of 29 patients, received 2.5 ml of
      hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml). Continuous monitoring of
      HR and SpO2 was conducted. Evaluation of sensory blockage and the motor block was done
      utilizing the Bromage scale. Following surgery, assessments were conducted. Pain in the ward
      and PACU was determined utilizing the visual analog scale (VAS).
    

Intervention name(s): FENT group; DEX group
Intervention type(s): Drug; Drug
Intervention description(s): Group FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg).; The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml).
Other intervention name(s): fentanyl group; dexmedetomidine group
Intervention MeSH terms: Fentanyl; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Fifty-eight adult patients were categorized into two groups. Group FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg). The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml).
Masking: Single (Investigator)
Primary purpose: Screening
Safety and Effectiveness of CPI-1189 in HIV-Infected Males on Combination Anti-HIV Drug Therapy
Condition: AIDS Dementia Complex; HIV Infections
MeSH terms: AIDS Dementia Complex; Dementia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see if it is safe to give multiple doses of CPI-1189 to
      HIV-infected, otherwise healthy, males. The study will also look at how CPI-1189 affects the
      levels of HIV, T cells (cells in the body that help fight infection), and three anti-HIV
      drugs (zidovudine, lamivudine, and indinavir) in the blood.

      Advanced HIV infection can cause AIDS dementia (brain damage due to HIV leading to losses of
      memory and muscle control). CPI-1189 may be able to postpone AIDS dementia or slow it down.
    

Detailed description: 
      Late-stage HIV infection can cause AIDS dementia (brain damage due to HIV leading to losses
      of memory and muscle control). CPI-1189 may be able to postpone AIDS dementia or slow it
      down.

      In this randomized, double-blind study, 48 HIV-infected, otherwise healthy, male volunteers
      receive either multiple-dose CPI-1189 or placebo by mouth for 15 consecutive days. Each
      dosing group begins 6 weeks following the start of the preceding group. Volunteers enter the
      study site the night before dosing on Days 1 and 15 and remain at the study site for 72 hours
      following dosing. Throughout the study, volunteers have physical exams and donate samples of
      blood, urine, cerebrospinal fluid, and sperm.
    

Intervention name(s): CPI-1189
Intervention type(s): Drug
Masking: Double
Primary purpose: Treatment
Keywords: Dose-Response Relationship, Drug; Drug Therapy, Combination; AIDS Dementia Complex; Zidovudine; Lamivudine; Indinavir; Reverse Transcriptase Inhibitors
Newborn Cortical Response to Pain and Non Pharmacological Analgesia
Condition: Analgesia
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      Minor painful procedures are frequently performed on newborn infants and non-pharmacological
      analgesia is commonly used. As more than one analgesic method may be applied simultaneously
      in clinical practice, the relative contribution and efficacy of analgesic components still
      needs to be further elucidated. In the present study neonatal cortical brain response during
      four types of non-pharmacological analgesia (oral glucose, expressed breastmilk, maternal
      holding plus oral glucose, maternal holding plus breastfeeding) will be studied. The aim is
      to assess the differential effect of oral solutions (glucose, breastmilk), when given alone
      or in combination with maternal relationship (holding, breastfeeding). The study will test
      the hypothesis that the mother-infant relationship would improve the analgesic effect of oral
      solutions.
    


Intervention name(s): Oral glucose solution + maternal holding; Breastfeeding; Oral glucose solution; Oral expressed breastmilk
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Infant will receive both the oral glucose solution and the contact with the mother; Infants will be breastfed; Infant will receive only oral glucose solution without contact with the mother; Infant will receive only oral expressed breast milk without contact with the mother
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: pain; infant; near-infrared spectroscopy; non pharmacological analgesia
Zink and Bone Strength
Condition: Coxarthrosis; Fracture of Femoral Neck
MeSH terms: Osteoarthritis, Hip
Study type: Observational

Summary: 
      Zink and bone strength
    

Detailed description: 
      blood- and urine samples collected from 20 OA patients and 20 osteoporosis patients who all
      had a hip-replacement. All patients were evaluated by DEXA-scanning.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        blood- and urine samples collected from 20 OA patients and 20 osteoporosis patients who all
        had a hip-replacement. All patients were evaluated by DEXA-scanning.