bioihbjkbjnl/mcl2 huggingface dataset:
Lofexidine ADME & Mass Balance in Volunteers
Condition: Normal Healthy Volunteers Will be Treated With Lofexidine to Understand the Absolute Bioavailability and Mass Balance Recovery of the Product
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the mass balance and absolute bioavailability of a
      single oral dose of 14C-labeled lofexidine compared to a single intravenous dose of
      lofexidine.
    


Intervention name(s): Lofexidine hydrochloride; Lofexidine hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): Single Dose = Solution containing 400 μg lofexidine HCl and a tracer amount of 14C lofexidine; Single Dose = 200 μg lofexidine in phosphate-buffered saline administered intravenously via infusion pump at a rate of 1 μg/min for 200 min
Intervention MeSH terms: Lofexidine; Clonidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; Normal Healthy Volunteers; Mass Balance; ADME; Absolute Bioavailability
Bioequivalnce Study of Loratadine / Pseudoephedrine Sulfate 10/ 240 mg Extended-Release Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of this study was to compare the single-dose relative bioavailability of
      Ranbaxy and Schering (Claritin-D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg
      Extended-Release Tablets, in a fully replicated design, under fasting conditions.
    

Detailed description: 
      The study was conducted as an open-label, randomized, Single-Dose, Fully replicated, 4-way
      Crossover Study to compare the single-dose relative bioavailability of Ranbaxy and Schering
      (Claritin_D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release
      Tablets, in Healthy adult Volunteers Under Fasting Conditions A total of 40 subjects (30
      males and 10 females) were included in this study, of which 36 (27 males and 9 females)
      finished the study according to the protocol.
    

Intervention name(s): Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets
Intervention type(s): Drug
Intervention MeSH terms: Loratadine; Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivaelnce Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended Release Tablets
A Study of Mitoxantrone Hydrochloride Liposome Injection in Chinese Patients With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and
      efficacy of mitoxantrone hydrochloride liposome injection in patients with advanced solid
      tumors.
    

Detailed description: 
      This is a multicenter, open-label, phase I dose-escalation and dose-expansion study aimed to
      evaluate the safety, tolerability, pharmacokinetics and efficacy of mitoxantrone
      hydrochloride liposome injection. This study consists of two phases: dose-escalation phase
      and dose expansion phase. The dose-escalation phase will be conducted to determine the
      maximum tolerated dose (MTD) of mitoxantrone hydrochloride liposome injection in patients
      with advanced solid tumors based on a 3+3 design. Patients enrolled in this phase will
      receive mitoxantrone hydrochloride liposome injection followed by a 3-week DLT observation
      period. After DLT observation, two to four dose cohorts will be selected for dose-expansion
      to further explore the safety and efficacy of study drug according to the dose-escalation
      results. In the dose-expansion phase, patients will receive the study drug every 3 weeks
      (q3w, a cycle) until disease progression, intolerable toxicity, death, or withdrawal by
      investigator or patient decision (a maximum of 6 cycles).
    

Intervention name(s): Mitoxantrone Hydrochloride Liposome injection
Intervention type(s): Drug
Intervention description(s): Mitoxantrone hydrochloride liposome injection will be administered intravenously once every 3 weeks (a cycle) for a maximum of 6 cycles.
Intervention MeSH terms: Mitoxantrone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tolerability and Pharmacokinetic Study of Econazole Nitrate Plus Benzydamine HCl Vaginal Pessary
Condition: Healthy Women
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the local tolerability of the new
      Econazole/Benzydamine pessary, in comparison with Econazole and Benzydamine stand-alone
      products and placebo. Pharmacokinetics of the study products after single and multiple
      applications o.d. for 3 days, overall local and general tolerability, safety and comfort of
      use will also be evaluated.
    


Intervention name(s): Econazole nitrate 150 mg plus Benzydamine HCl 6 mg vaginal pessary; Placebo plus Econazole nitrate 150 mg vaginal pessary; Placebo plus Benzydamine HCl 6 mg vaginal pessary; Placebo vaginal pessary
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Econazole nitrate 150 mg plus Benzydamine HCl 6 mg vaginal pessary
Intervention MeSH terms: Econazole; Benzydamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Pharmacokinetics; Econazole nitrate 150mg; Benzydamine HCl 6mg; Vaginal pessary; Tolerability
Safety and Effectiveness Study of Intranasal Insulin Glulisine on Cognitive and Memory in Mild-Mod AD Patients.
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the effect of the rapidly acting intranasal
      insulin derivative (glulisine) on memory and cognition in 12 patients suffering from
      mild-moderate Alzheimer's Disease (AD) using a double-blind placebo-controlled single dose
      study. This study will further assess safety of insulin glulisine as well as the effects of
      this drug on olfaction.
    

Detailed description: 
      A single center, phase II randomized, double-blind, placebo-controlled, cross-over study
      designed to assess the efficacy and safety of intranasally (IN) delivered insulin glulisine
      versus placebo in patients aged 65-85 with mild-moderate Alzheimer's Disease (AD). Twelve AD
      subjects (six female and six male) will be randomized to receive a single dose of either 20
      IU/IN insulin glulisine or placebo using the MAD 300 device.
    

Intervention name(s): Insulin glulisine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Single treatment, 20 IU/Intranasal (.1ml/10 units Intranasally in each nostril); Single treatment,(saline) 20 IU/Intranasal (.1ml/10units intranasally in each nostril)
Other intervention name(s): Apidra; salt water
Intervention MeSH terms: Insulin glulisine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Memory; Insulin glulisine; Alzheimer's Disease
Comparison of Human Insulin to Insulin Inhalation Solution in Children With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Europe. The aim of this trial is to compare the pharmacokinetic
      profile of two different methods of insulin administration in children with type 1 diabetes.
    


Intervention name(s): human insulin; inhaled human insulin
Intervention type(s): Drug; Drug
Other intervention name(s): Actrapid®; Novolin® R
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cervical Manipulation (OAA Technique) in Exophories
Condition: Exophoria
MeSH terms: Exotropia
Study type: Interventional

Summary: 
      Objetive: to assess the efficacy of the occipito-atlas-axis cervical manipulation technique
      to correct ocular divergence in subjects with exophoria.

      Design: quantitative, experimental, longitudinal and prospective study.

      Subjects: subjects over 18 years of age, with exophorias, without heterotropies and who do
      not present a contraindication to cervical manipulation.

      Methods:Subjects with this ocular mobility dysfunction are going to be evaluated objectively
      with the Alternate Cover Test. The ocular deviation will be measured at 40 cm and at 4
      meters. The individuals who were part of the experimental group underwent the OAA
      manipulation technique, and to those who were part of the control group a placebo maneuver.
      Two measurements were taken from this moment, one immediately after the execution of the
      technique and another one week later.
    


Intervention name(s): O-A-A; cranial listening
Intervention type(s): Procedure; Procedure
Intervention description(s): patient is supine, and the therapist stands on the side to be manipulated. The cranial hand of the therapist globally grasps the patient's skull and turns the patient's neck on that same side. The caudal hand is placed on the patient's face. The technique is performed by an impulse in pure rotation on the side that the cervical region is rotated, with a helical movement.; The patient is in the supine position, and the therapist sitting at the head of the patient. The therapist places his hands on the head of the patient, the thumbs touch each other, without touching the vault cranial. A perception of the cranial rhythm is carried out passively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cervical manipulation; disorder ocular motility; musculoeskeletal; strabismus
Effect of Add-on Citalopram to Risperidone on Negative Symptoms in Schizophrenia
Condition: Schizophrenia; Negative Symptoms
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      Negative symptoms in schizophrenia present a challenge to the clinician owing to their poorer
      response to conventional treatment with antipsychotics. Negative symptoms in schizophrenia
      may be secondary to psychotic symptoms, depressive symptoms, drug-related side effects or
      lack of environmental stimulation. Alternately, they may represent core features of the
      illness, characterized as primary deficit symptoms. Previous studies have suggested that
      atypical antipsychotics may be beneficial in improving deficit symptoms of schizophrenia.
      This study aimed at characterizing the nature of improvement of negative symptoms in the
      early phase (12 weeks) of treatment with the atypical antipsychotic, risperidone. In order to
      account for factors contributing to improvement in secondary negative symptoms, ratings were
      carried out of change in positive symptoms, depressive symptoms and drug-related side
      effects. Further, add-on citalopram or placebo were administered in a double-blind design to
      study the effect of selective serotonin reuptake inhibitor (SSRI) augmentation of risperidone
      on negative symptoms. The investigators hypothesized that the improvement in negative
      symptoms during the initial phase (12 weeks) of treatment with risperidone will be largely
      accounted for by improvement in secondary negative symptoms, rather than of the primary
      deficit symptoms.
    


Intervention name(s): Risperidone; risperidone; Citalopram; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Risperidone: tablet; oral; 4-6 mg/day; once daily; 12 weeks; Risperidone: tablet; 4-8 mg/day; once daily; 12 weeks; Citalopram: tablet; oral; 20 mg/day; once daily; 12 weeks; Placebo: once daily
Other intervention name(s): Respidon; Respidon; Citopam
Intervention MeSH terms: Risperidone; Citalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; risperidone; citalopram; secondary negative symptoms
A Study to Gain Information How Well Dexpanthenol Dermal Spray Helps the Face Skin to Recover After Cosmetic Lasering
Condition: Erythema; Skin Recovery
MeSH terms: Erythema
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, researchers want to learn more about the effect of dexpanthenol dermal spray
      on skin recovery and reduction of skin redness after a dermatological procedure (non-ablative
      laser) on the face for treatment of fine wrinkles, scars, open pores and change of
      pigmentation.

      After the dermatological procedure, participants will return within 3 weeks for 4 visits to
      the study center to investigate the skin conditions such redness, irritation, softness and
      possible side effects. In addition, study participants will be asked about their general
      acceptance of dexpanthenol dermal spray.
    

Detailed description: 
      The primary objective is to evaluate the efficacy of the test product to aid skin recovery
      and reduction of erythema after non-ablative lasering on the face.

      Secondary objectives comprise clinical efficacy with respect to skin hydration, softness,
      vitality, appearance etc. and skin recovery, consumer judgement of product performance and
      acceptability, and safety.
    

Intervention name(s): BAY207543 (Bepanthol, Bepantol® Derma Spray); Semisolid vaseline
Intervention type(s): Drug; Other
Intervention description(s): Product is applied to one hemiface.; Product is applied to one hemiface.
Intervention MeSH terms: Petrolatum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Dermal spray; Ablative lasering; Skin hydration; Consumer satisfaction; Sensorial perception
The Effect of Black Currant on Postprandial Glucose Metabolism
Condition: Postprandial Hyperglycemia; Prediabetic State
MeSH terms: Hyperglycemia; Prediabetic State
Study type: Interventional

Summary: 
      The study examines the effect of black currant on glucose and insulin concentrations after a
      meal. In addition, the cytokine and free fatty acids levels are of interest.
    

Detailed description: 
      The study examines the effect of black currant on glucose and insulin concentrations after a
      meal.

      Healthy (n= 30) volunteers are recruited to participate in four consecutive visits in the
      research laboratory, when four meals are served in randomised order. Meals are: black currant
      puree, black currant and quinoa based snack, quinoa base and liquid containing glucose,
      fructose and sucrose. The meals contain the same amount of carbohydrates.

      In addition to glucose and insulin concentration, cytokine and free fatty acid concentrations
      are measured after each meal.
    

Intervention name(s): Black currant; Black currant-quinoa product; Quinoa base
Intervention type(s): Other; Other; Other
Intervention description(s): The effect of black currant puree will be compared with black currant-quinoa product, quinoa base and with liquid with glucose, fructose and sucrose
Experimental: Black currant and quinoa product
Active Comparator: Quinoa base Meal study comparing the effect of black currant puree with liquid with glucose, fructose and sucrose, black currant and quinoa product and quinoa base; The effect of black currant puree will be compared with black currant-quinoa product; The effect of black currant puree will be compared with quinoa base
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Meal studies in randomised order
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: berries; black currant; glucose; glycemia; quinoa
Muscle Energy Technique and Facet Joint Mobilization in Chronic Neck Pain.
Condition: Chronic Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The purpose of the study is to compare the muscle energy technique, facet joint mobilization
      and conventional physical therapy in individuals with chronic neck pain on cervical lordosis,
      cervical range of motions, numeric pain rating scale and NDI. A randomized control trial was
      conducted at physiotherapy department of HIT hospital, Taxila Cantt. The sample size was 105
      calculated through open-epi tool. The participants were divided into three interventional
      groups, experimental group (1), experimental group (2), and control group (3) each having 35
      participants. The study duration was six months. Sampling technique applied was Purposive
      sampling for recruitment and group randomization using sealed envelope method. Only 35 to 50
      years participants with 4-8 pain intensity on NPRS in cervical region were included in the
      study. Goniometer, Posterior tangent method on lateral radiographs for cervical curve and
      Self structured Questionnaire. Data was collected at baseline then 2 and 4 weeks after the
      application of interventions. Data analyzed through SPSS version 21.
    


Intervention name(s): Muscle energy Technique
Intervention type(s): Other
Intervention description(s): Muscle Energy technique was used to increase the strength of weak muscles,relaxation of tightened muscles in result mobilizes the restricted joint segments.MET's group received 3-5 repetition of post isometric relaxation (PIR).
Treatment through Facet Joint Mobilization based on 3 sets of 15 repetitions of unilateral poster-anterior glide (UPA) using initially grade I & II mobilizations followed by grade III of mitland glides on selected tender segments and 5 repetitions of extension sustained natural apophyseal glides (SNAGs) on hypo mobile segments.
Conventional therapy comprising of stretching and isometric strengthening exercises in combination with TENS and heat therapy.
Other intervention name(s): Facet Joint Mobilization; Conventional Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: cervical pain; chronic neck pain,; Muscle energy technique,; Facet join mobilization,; cervical lordosis,; cervical curve
Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions
Condition: Herpes Zoster; Shingles; Genital Herpes
MeSH terms: Herpes Simplex; Herpes Zoster; Herpes Genitalis
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Valacyclovir
      Hydrochlorothiazide Caplet under fed conditions.
    


Intervention name(s): Valacyclovir Hydrochloride
Intervention type(s): Drug
Intervention description(s): 1000 mg caplet
Other intervention name(s): Valtrex
Intervention MeSH terms: Valacyclovir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) Low Dose in Adolescents With ADHD
Condition: ADHD
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of low doses of SPN-812 in adolescents 12-17
      years of age.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group
      study, to assess the efficacy and safety of SPN-812 as monotherapy for the treatment of
      adolescents 12-17 years old with ADHD.
    

Intervention name(s): Placebo; 200mg SPN-812; 400mg SPN-812
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo was administered once daily; 200mg SPN-812 was administered once daily and compared to placebo; 400mg SPN-812 was administered once daily and compared to placebo
Other intervention name(s): PBO; SPN-812; SPN-812
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Ranibizumab "Treat and Extend" in Diabetic Macular Edma
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to explore a more individualized treatment regime based on achievement
      of disease stability to define a personal optimal treatment interval with ranibizumab in
      patients with visual impairment due to diabetic macular edema.
    


Intervention name(s): Ranibizumab
Intervention type(s): Drug
Intervention MeSH terms: Ranibizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetic macular edema; Macular edema; DME; Diabetic retinopathy; Diabetic eye disease; anti-VEGF; ranibizumab; Lucentis
Levetiracetam for Neuroprotection Against Corticosteroid-induced Hippocampal Dysfunction: A Proof of Concept Study
Condition: Memory Loss Associated With Corticosteroid Use; Manic State Associated With Corticosteroid Use
MeSH terms: Memory Disorders; Mania
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research is to determine whether the memory impairment and manic symptoms
      (feelings of agitation, overexcitement or hyperactivity) typically seen in those on
      corticosteroid therapy is decreased with a seizure medication called levetiracetam compared
      to placebo (an inactive substance). Since increased levels of cortisol (the body's natural
      corticosteroid) in the body are frequently associated with memory impairment interventions
      that may prevent or reverse this are of great importance.

      It is hypothesized that patients who are scheduled to receive prescription corticosteroid
      therapy who are given levetiracetam pretreatment will show lesser memory impairment and manic
      symptoms than those receiving placebo.
    


Intervention name(s): Levetiracetam, Keppra
Intervention type(s): Drug
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Magnetic Resonance (MR) Imaging in the Post Operative Follow-up of Cholesteatoma in Children
Condition: Cholesteatoma
MeSH terms: Cholesteatoma
Study type: Interventional

Summary: 
      Classical imaging techniques are inaccurate to detect residual cholesteatoma. The aim of our
      study is to evaluate the value of diffusion-weighted MR imaging and delayed contrast enhanced
      T1 weighted spin-echo sequences in the detection of residual cholesteatoma in children, in a
      large serie of surgically verified cases.
    

Detailed description: 
      Classical imaging techniques are inaccurate to detect residual cholesteatoma. Thin-section CT
      detects that the postoperative cavity is filled with a soft tissue mass. Classical MR imaging
      (T2 and T1 weighted spin-echo sequences) can not provide additionnal information about the
      nature of this filling : cholesteatoma, granulation or fibrous tissue.
    

Intervention name(s): MR Imaging
Intervention type(s): Other
Intervention description(s): MR imaging in the post operative follow-up of cholesteatoma in children
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic