bioihbjkbjnl/mcl2 huggingface dataset:
ASP8825 - Study in Patients With Restless Legs Syndrome
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      To demonstrate the superiority of ASP8825 over placebo and the dose response in patients with
      restless legs syndrome
    

Detailed description: 
      Three doses of ASP8825 are compared to placebo in efficacy and safety point of view in
      patients with restless legs syndrome
    

Intervention name(s): ASP8825; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): XP13512
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ASP8825; Restless legs Syndrome; XP13512
Post Market (Libra/LibraXP System) Deep Brain Stimulation (DBS) Parkinson's Disease Study
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The objective of this study is to evaluate the effectiveness of Deep Brain Stimulation as an
      adjunctive treatment for reducing some of the symptoms of advanced, levodopa-responsive
      Parkinson's disease that are not adequately controlled with medication.

      It is the first study in Parkinson patients outside the US with a Deep Brain Stimulation
      system using constant current instead of constant voltage and using a lead with an active
      electrode tip.
    

Detailed description: 
      This study is designed as a prospective, observational, non-randomized, multi-centered study
      for 12 months in duration from implantation with the subjects being used as their own
      control. The primary outcome assessment will occur at three months: however, subjects will be
      followed for one year.

      A comparison of measures within the same person from pre-treatment to post-treatment will be
      performed. Also, pre-treatment and post-treatment group means and standard deviations will be
      determined.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Libra™/LibraXP™ DBS System Eligible subjects in this study will be screened to confirm that
        they meet the strict guidelines for advanced, levodopa-responsive Parkinson's disease that
        are not adequately controlled with medication followed by surgery to implant the
        Libra™/LibraXP™ deep brain simulation system.
Bioequivalence Study of Tretinoin Gel 0.05% to Brand Tretinoin Gel
Condition: Acne
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a double-blind, randomized, three-treatment, parallel study. Normal, healthy male
      and female children and adults (i.e., ages 12 to 40 years) with at least Grade 2 (i.e., mild
      severity) acne vulgaris were treated on the full face once daily for 84 days with the
      Tretinoin Gel 0.05%, Brand (tretinoin) Gel 0.05%, or Gel Vehicle. Acne lesions were graded by
      a single blinded observer at screening and at Weeks 0 (i.e., baseline), 2, 4, 8, and 12 at
      each location.
    

Detailed description: 
      This was a double-blind, randomized, three-treatment, parallel study conducted at three
      locations with a single investigator. Normal, healthy male and female children and adults
      (i.e., ages 12 to 40 years) with at least Grade 2 (i.e., mild severity) acne vulgaris were
      treated on the full face once daily for 84 days with the Tretinoin Gel 0.05%, Brand
      (tretinoin) Gel 0.05%, or Gel Vehicle. Acne lesions were graded by a single blinded observer
      at screening and at Weeks 0 (i.e., baseline), 2, 4, 8, and 12 at each location.

      The assigned study treatment was self-applied topically once daily for 84 consecutive days.
      Scheduled study visits included:

        -  Visit 1 (Baseline Visit, Day 0)

        -  Visit 2 (First Interim Visit, Day 14)

        -  Visit 3 (Second Interim Visit, Day 28)

        -  Visit 4 (Third Interim Visit, Day 56)

        -  Visit 5 (Forth Interim Visit, Day 84)

      A window of ± 4 days was considered acceptable for each scheduled visit following the
      Baseline Visit. Subjects were admitted into the study if they had a clinical diagnosis of
      acne vulgaris and if they met the inclusion/exclusion criteria. During the study visits, the
      following procedures were performed:

        -  Counts of inflammatory, non-inflammatory, and nodulocystic lesions

        -  The Investigator's Global Assessment (IGA)

        -  Assessment of application site reactions Safety was assessed by the monitoring of AEs
           and documenting signs and/or symptoms of application site reactions.
    

Intervention name(s): Tretinoin
Intervention type(s): Drug
Intervention description(s): Treatment of acne once daily in evening
Other intervention name(s): Placebo
Intervention MeSH terms: Tretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered NNC0148-0287 (Insulin 287) in Subjects With Type 2 Diabetes
Condition: Diabetes; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate the safety,
      tolerability, pharmacokinetics (the exposure of the trial drug in the body) and
      pharmacodynamics (the effect of the investigated drug on the body) of subcutaneously
      administered NNC0148-0287 (insulin 287) in subjects with type 2 diabetes
    


Intervention name(s): Insulin icodec; insulin degludec; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered once-weekly subcutaneously (s.c., under the skin) for 35 days; Administered once-daily subcutaneously (s.c., under the skin) for 35 days; Administered subcutaneously (s.c., under the skin) once-daily for 35 days
Other intervention name(s): insulin 287
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cognitive Processing Therapy in Syrian Women Exposed to IPV
Condition: Depression; Anxiety; PTSD
MeSH terms: Depression
Study type: Interventional

Summary: 
      This study aims to explore the efficacy of cognitive processing therapy (CPT) in treating
      depression, anxiety, PTSD, and difficulties with emotion regulation in Syrian females who
      have suffered intimate partner violence (IPV). Clinicians will conduct interviews with women
      and request that they complete the CAPS, Beck Depression Inventory II, Beck Anxiety
      Inventory, and DERS during pretreatment, posttreatment, and at the 12-month follow-up
    

Detailed description: 
      This study aims to explore the efficacy of cognitive processing therapy (CPT) in treating
      depression, anxiety, PTSD, and difficulties with emotion regulation in Syrian females who
      have suffered intimate partner violence (IPV). Clinicians will conduct interviews with women
      and request that they complete the CAPS, Beck Depression Inventory II, Beck Anxiety
      Inventory, and DERS during pretreatment, posttreatment, and at the 12-month follow-up.
      Cognitive processing therapy (CPT) may have a substantial therapeutic benefit in the
      treatment of depression, anxiety, PTSD, and difficulties in emotion regulation among Syrian
      females who have suffered intimate partner violence.
    

Intervention name(s): Cognitive Processing Therapy (CPT)
Intervention type(s): Behavioral
Intervention description(s): The CPT therapist will teach the patient about PTSD, depression, and anxiety, and outline the treatment regimen and rationale for its effectiveness. In the initial sessions, women will be asked to express their impact statements on the intimate partner violence to which they had been subjected. Women will be taught how to differentiate between events, thoughts, and emotions, as well as their interrelationships. Thoughts of self-blame and other misconceptions of the situation will be addressed using Socratic questioning. Women will be instructed on how to detect and counteract negative thoughts, as well as how to communicate more effectively. Women will be encouraged to evaluate negative thinking relating to five themes: safety, trust, power/control, self-esteem, and intimacy. During the final sessions, their impact statements on the violence to which they had been subjected will be altered to include emotional and cognitive insights obtained during the CPT.
Other intervention name(s): CPT
Intervention model: Single Group Assignment
Intervention model description: The current study is a clinical trial, including the repeated assessments of a single sample of Syrian women. Pre-treatment, posttreatment and 12-month posttreatment assessments were conducted on participants. PTSD severity, depression, anxiety and difficulties in emotion regulation will be assessed as outcomes.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive Processing Therapy; Syrian women; Mental health
Comparison Between Magnetic Field and Laser Therapy in Management of Trigeminal Neuralgia
Condition: Trigeminal Neuralgia
MeSH terms: Trigeminal Neuralgia; Neuralgia
Study type: Interventional

Summary: 
      Trigeminal neuralgia (TN) was defined by The International Association for the Study of Pain
      (IASP) as severe, sudden, usually unilateral, stabbing, brief, recurrent attacks of pain in
      one or more distributional branches of the trigeminal nerve. The purpose of the current study
      will to investigate the effect of Low level laser therapy versus electromagnetic therapy on
      diabetic trigeminal neuralgia pain intensity and amplitude of the compound muscle action
      potential of the masseter and temporalis muscles in diabetic TN patients.
    


Intervention name(s): Electromagnetic therapy.; Low level laser therapy (LLLT)
Intervention type(s): Other; Other
Intervention description(s): Electromagnetic therapy will be applied for 20 min/ session for (3 days/ week for two months) to the group intervention.; Low level laser therapy (LLLT) will be applied for 20 min/session laser scanner for three days each week for two months to the group intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Study of the Safety of USB005 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability and pharmacokinetics of USB005
      (aclerastide) Ophthalmic Solution.
    

Detailed description: 
      This is a Phase 1, single-center, randomized, double-masked, placebo-controlled, multiple
      ascending dose study in healthy volunteers. Thirty-two male and female volunteer subjects,
      between the ages of 18 and 64 years of age, will be enrolled. Subjects will be enrolled in
      four dose-escalating cohorts of eight subjects and randomized to USB005 or placebo in a ratio
      of 3:1. Cohorts will be enrolled sequentially starting at the lowest concentration. The four
      cohorts will be identified as: Cohort 1(0.03% USB005 or placebo), Cohort 2 (0.1% USB005 or
      placebo), Cohort 3 (0.3% USB005 or placebo), and Cohort 4 (0.45% USB005 or placebo).
      Volunteers in the four cohorts will self-administer a single drop of USB005 or placebo into
      the study eye, three times a day for 28 days. The study eye in which the drug is applied to
      will be determined based on screening assessments. Subjects will be followed for 8 days after
      the last USB005 or placebo administration.

      The safety and tolerability of USB005 will be demonstrated by local toxicity, adverse events,
      laboratory assessments, vital signs, and a comprehensive eye exam. Plasma samples will be
      taken at various time points throughout the study to characterize the pharmacokinetics of
      USB005. Dropouts will be replaced after consultation with the Sponsor.
    

Intervention name(s): USB005 (aclerastide) Ophthalmic Solution; USB005 Ophthalmic Solution Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Aclerastide ([Nle3]-Angiotensin II (1-7)) is aseptically formulated in USB005 Ophthalmic Solution for topical ophthalmic administration. Active pharmaceutical ingredient (API) levels ranging from 0.03% to 0.45% are formulated in a sterile vehicle consisting of 0.06% Sodium Phosphate Monobasic Anhydrous, USP; 3% Glycerol, USP; 1.4% Polyvinyl Alcohol, USP; and 0.5% Hydroxyethylcellulose (HEC 250 HHX), NF in Sterile Water for Injection, USP.; A clinical placebo formulated with the same excipients and packaged in the same container closure system as the active product, USB005 (aclerastide) Ophthalmic Solution.
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NorLeu3-A(1-7); USB005; aclerastide; corneal repair; corneal injury
Enhanced Recovery After Surgery (ERAS) in Gynecological Surgery (ERASGS-01)
Condition: Gynecologic Disease; Gynecologic Cancer
MeSH terms: Genital Diseases, Female
Study type: Interventional

Summary: 
      Enhanced recovery programs are composed of preoperative, intraoperative and postoperative
      strategies combined to form a multi-modal pathway. ERAS requires a multidisciplinary team of
      anesthetists, surgeons and nurses for successful implementation and realization of its
      advantages.The aim of this study is to compare outcomes of conventional perioperative care
      with those of an enhanced recovery after surgery (ERAS) perioperative care plan in women
      undergoing surgery for gynecologic cancer or suspected gynecologic disease.
    

Detailed description: 
      The study design is a two-arm, randomized, controlled trial. The control arm will consist of
      standard conventional perioperative care. The intervention arm will consist of a
      protocol-driven ERAS program. The investigators believe that this information will be very
      useful because although there is a national interest in creating ERAS protocols for
      gynecology, there currently is very little published on the subject. Investigators
      hypothesize that those patients randomized to the ERAS protocol will have shorter lengths of
      hospital stay and complications, without increasing readmission rates. The investigators
      would like to publish the investigators' results and protocol as a resource for other
      institutions to adopt.
    

Intervention name(s): ERAS protocol
Intervention type(s): Procedure
Intervention description(s): preoperative management Optimization of relevant medical uncontrolled situations, avoid fasting, avoid bowel preparation, avoid premedications, nutritional assessment, stop smoking, stop alcohol and appropriate counselling
intraoperative management Multimodal prevention of prophylaxis against nausea and vomiting (PONV) (according to preoperative assessment of Apfel Score) with a combination of multiple antiemetic drugs.
postoperative management Postoperative pain control is obtained with opioid sparing strategies, in order to avoid Post Operative Ileus (POI) and PONV.
It is proposed to chew gum three times daily , fluid therapy, early mobilization, early feeding within 2 hours postoperative for at least 15 minutes and eventually to promote a faster bowel function.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: preoperative / intraoperative/ postoperative management
Comparison of Absorption of Budesonide and Formoterol From Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with
      the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.
    


Intervention name(s): Charcoal and Budesonide/formoterol Easyhaler 320/9 microg; Charcoal and Symbicort Turbuhaler; Budesonide/formoterol Easyhaler 320/9 microg; Symbicort Turbuhaler forte
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 inhalations as a single dose; 2 inhalations as a single dose; 2 inhalations as a single dose; 2 inhalations as a single dose
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination; Charcoal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Late Compared to Early Physiotherapy Following Knee Dislocation
Condition: Traumatic Knee Dislocation
MeSH terms: Joint Dislocations; Knee Dislocation
Study type: Interventional

Summary: 
      A knee dislocation is an unusual and extremely serious injury and is defined as complete
      displacement of the tibia with respect to the femur, usually with disruption of 3 or more of
      the stabilizing ligaments. When the knee dislocates, there is often significant damage to the
      soft-tissues envelope surrounding the joint, including adjacent neurovascular structures. Not
      surprisingly, this injury is a profoundly debilitating, life-altering event, with the
      potential to necessitate career change in athletes and laborers alike. Current evidence
      indicates that operative management for these injuries is more effective at returning
      patients to pre-morbid range of motion (ROM) and activity than conservative management. Post
      operative rehabilitation programs for these patients must balance the need for stability of
      their surgical repair and knee ROM and functionality. Experimental data suggests that
      post-operative immobilization offers greater protection of the surgical reconstruction,
      whereas immediate, aggressive physiotherapy may be more effective at preventing
      arthrofibrosis stiffness. The investigators are proposing a randomized clinical trial
      comparing early physiotherapy (day one post op) versus immobilization for three weeks then
      initiation of physiotherapy. The physiotherapy progams will be identicalbe in all aspects
      except for progam initiation.
    


Intervention name(s): Early Physiotherapy start
Intervention type(s): Other
Intervention description(s): Physiotherapy starting at one day post op
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Genetic Determinants of the Metabolism of Non-nucleoside Reverse Transcriptase Inhibitors
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To see if certain variations in the CYP2B6 gene contribute to differences in plasma drug
      levels and central nervous system side affects in people who take nevirapine or efavirenz.
    


Intervention name(s): Nevirapine and Efavirenz
Intervention type(s): Drug
Intervention description(s): single oral dose 200mg of nevirapine and single oral dose 600 mg of efavirenz
Other intervention name(s): Viramune; Sustiva
Intervention MeSH terms: Efavirenz; Nevirapine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Nevirapine; Efavirenz; pharmacokinetics; healthy; CYP2B6; HIV/AIDS
A Clinical Comparison of Two Daily Disposable Contact Lenses.
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the clinical performance of two daily disposable
      contact lenses.
    


Intervention name(s): etafilcon A; nelfilcon A
Intervention type(s): Device; Device
Intervention description(s): Contact Lens; Contact Lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Doravirine (MK-1439) (MK-1439-019)
Condition: HIV-1 Infection
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aimed to investigate the influence of hepatic insufficiency on the
      pharmacokinetics (PK) of doravirine (MK-1439). In Part 1, PK of doravirine in participants
      with moderate hepatic insufficiency was compared with that of healthy control subjects
      matched with regard to mean age and weight. If a clinically meaningful increase in exposure
      of doravirine was observed in participants with moderate hepatic insufficiency in Part 1,
      study Part 2 was to evaluate PK of doravirine in participants with mild hepatic
      insufficiency.
    


Intervention name(s): Doravirine
Intervention type(s): Drug
Intervention description(s): Following an overnight fast, a single tablet of 100 mg doravirine was be administered orally
Other intervention name(s): MK-1439
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of AM-111 in Patients With Acute Sensorineural Hearing Loss
Condition: Hearing Loss
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine whether AM-111 is effective in the treatment of
      acute inner ear hearing loss (acute sensorineural hearing loss, ASNHL).
    


Intervention name(s): AM-111; placebo
Intervention type(s): Drug; Drug
Intervention description(s): single intratympanic injection; single intratympanic injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sudden hearing loss; Sudden deafness; Acoustic trauma; Noise trauma