bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Autologous Platelet-Rich Plasma for Erectile Dysfunction.
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate changes in vascular parameters and International
      Index of Erectile Function (IIEF) scores with the administration of Platelet Rich Plasma
      (PRP) to participants with Erectile Dysfunction (ED)
    


Intervention name(s): Autologous Platelet Rich Plasma; Saline solution
Intervention type(s): Drug; Other
Intervention description(s): Each injection session will consist of a total of 5 mL PRP infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum.; Each injection session will consist of a total of 5 mL saline solution infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum
Other intervention name(s): PRP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ED
Pharmacokinetics of Nilotinib in Subjects With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a formal assessment of the impact of hepatic function impairment on the
      pharmacokinetics of nilotinib
    


Intervention name(s): Nilotinib
Intervention type(s): Drug
Other intervention name(s): AMN107
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nilotinib; hepatic impairment; Child-Pugh scale; PK; healthy, subject(s); Subjects with impaired hepatic function and healthy subjects
Pharmacokinetics, Pharmacodynamics, and Safety of Moss-aGalactosidase A in Patients With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Six patients with Fabry disease will be recruited. Patients will receive a single dose of 0.2
      mg/kg recombinant human alpha-galactosidase A produced in moss (moss-aGal) as intravenous
      infusion. Patients will be hospitalized during the infusion and for at least 24 hours after
      the end of the infusion. Treatment will be administered sequentially: if a patient shows no
      safety concerns on the treatment day, treatment of the next patient will commence on the
      following day.
    


Intervention name(s): Moss-aGal (recombinant human alpha-galactosidase A produced in moss)
Intervention type(s): Drug
Intervention description(s): Single i.v. Infusion of 0.2 mg/kg moss-aGal over 60 minutes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
Condition: Relapsing-remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod
      (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting
      multiple sclerosis (RRMS)
    


Intervention name(s): Fingolimod 1.25 mg; Fingolimod 0.5 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients self-administered fingolimod 1.25 mg capsules orally once daily.; Patients self-administered fingolimod 0.5 mg capsules orally once daily.; Patients self-administered a fingolimod placebo capsule orally once daily.
Intervention MeSH terms: Fingolimod Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; FTY720; Fingolimod
A Study Evaluating the Bioequivalence of VIAject®7 Compared to VIAject®25 and Comparing the Pharmacokinetic and Pharmacodynamic Properties of VIAject®7 to Insulin Lispro in Subjects With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of this study is to test for bioequivalence of VIAject®7 and VIAject®25
      and to compare the pharmacokinetic/Pharmacodynamic/tolerability characteristics of VIAject®7
      with those of VIAject®25 and insulin lispro.
    


Intervention name(s): VIAject®25; VIAject®7; Insulin Lispro
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Two vial presentation for reconstitution and single dose of 12 IU subcutaneous injection and 25 IU/mL; One vial presentation and single dose of 12 U for subcutaneous injection and 100 IU/mL; One vial presentation and single dose of 12 IU for subcutaneous injection and 100 IU/mL
Intervention MeSH terms: Insulin; Insulin Lispro; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study Comparing Total Extraperitoneal Patch "TEP" Versus Lichtenstein According Chronic Pain
Condition: Chronic Pain; Sexual Dysfunction
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The purpose of this study is to se if there is a difference regarding chronic pain and sexual
      dysfunction one and tree years after laparoscopic un fixated preperitoneal mesh versus gold
      standard open fixated on lay mesh in inguinal hernia surgery.

      Long term cross-sectional follow-up comparing different instruments for measurement of
      chronic pain.
    

Detailed description: 
      Prospective randomized study comparing total extraperitoneal patch TEP versus open onlay mesh
      according to Lichtenstein in primary unilateral inguinal hernias in men between 30 to 75
      years of age. Non fixated polypropylene mesh is used in the TEP operation and fixated light
      weight polypropylene mesh is used in the Lichtenstein procedure. The aim is to study
      chronical pain and sexual dysfunction. Clinical examination according nerve function, hernia
      status and genital findings are performed together with a questionnaire including SF36,
      Inguinal Pain Questionnaire(IPQ), sexual function are registered preoperatively, one and tree
      years postoperatively.

      Cross-sectional follow-up in median 7.5 years using enquiries for comparison of different
      pain instruments to evaluate the effect of chronic pain on physical activity.
    

Intervention name(s): Total Extraperitoneal repair (TEP); Lichtenstein
Intervention type(s): Procedure; Procedure
Intervention description(s): Operation for primary inguinal hernias i men; Operation for primary inguinal hernias i men
Other intervention name(s): Total extraperitoneal patch; Laparoscopic hernia operation; Hernia mesh operation; Open on lay mesh repair; Anterior mesh repair
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Inguinal hernia; TEP; Lichtenstein; Mesh; Randomized; Chronic pain; Sexual dysfunction
Efficacy of BGG492 in Individuals With Refractory Partial Seizures Undergoing Inpatient Evaluation for Epilepsy Surgery
Condition: Seizures; Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will asses the safety and efficacy of BGG492 in reducing the seizure rate in
      therapy-refractory partial seizures.
    


Intervention name(s): Investigational new drug, company code: BGG492; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: epilepsy; seizure; monotherapy trials; partial seizure; Partial seizures and undergoing evaluation for epilepsy surgery
Analgesia For Positioning Patient With Femur Fracture For Spinal Anaesthesia
Condition: Femoral Fracture
MeSH terms: Fractures, Bone; Femoral Fractures
Study type: Interventional

Summary: 
      This study is performed to determine the efficacy of ultrasound-guided fascia iliaca
      compartment block during positioning for spinal anaesthesia in patient undergoing repair of
      proximal femur fracture surgery comparing with intravenous fentanyl.
    

Detailed description: 
      This a prospective, single-blind, randomized control study that compare the efficacy of
      ultrasound-guided fascia iliaca compartment block with intravenous fentanyl in positioning
      patient with femur fracture for spinal anaesthesia.
    

Intervention name(s): Ropivacaine; Fentanyl; Ultrasound
Intervention type(s): Drug; Drug; Device
Intervention description(s): Fascia iliaca compartment block using ropivacaine; Intravenous fentanyl; Ultrasound-guided fascia iliaca compartment block
Intervention MeSH terms: Fentanyl; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: fascia iliaca compartment block; fentanyl
Study to Evaluate Drug-drug Interaction, Safety and Tolerability in Case of the Co-administration of D565 and D930
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomized, open-label, 2-period, parallel group, multiple-dose phase 1 study
      to evaluate drug-drug Interaction, safety and tolerability in case of the co-administration
      of D565 and D930, in healthy male subjects
    

Detailed description: 
      To healthy male subjects of thirty-two (32), Investigational products are administered
      following treatments in each period
    

Intervention name(s): D565; D930
Intervention type(s): Drug; Drug
Intervention description(s): Q.D. in both eye; T.I.D in both eye
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Performance of the AtbFinder® Test System for Selection of Antibiotic Therapy in Persons With Cystic Fibrosis
Condition: Cystic Fibrosis; Lung Infection Bacterial
MeSH terms: Bacterial Infections; Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      This prospective case-control study was planned to evaluate the efficacy of antibiotic
      therapy selected with the AtbFinder® in persons with cystic fibrosis.
    

Detailed description: 
      This pilot study entitled "Clinical Performance of the AtbFinder® diagnostic test system for
      selection of antibiotic therapy in persons with cystic fibrosis " was designed to demonstrate
      the clinical performance of antibiotics selected with the AtbFinder® for the treatment of
      lung infections in persons with cystic fibrosis.
    

Intervention name(s): AtbFinder
Intervention type(s): Device
Intervention description(s): In the present study, we provided a prospective evaluation of the effectiveness of antibiotics selected with AtbFinder compared to a retrospective analysis of antibiotic efficacy selected with conventional culture-based antibiotic susceptibility tets in patients with cystic fibrosis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effects of Curcumin-containing Toothpaste on Dental Biofilm and Associated Oral Halitosis
Condition: Halitosis
MeSH terms: Halitosis
Study type: Interventional

Summary: 
      Purpose: To investigate the short-term clinical effect of curcumin-containing toothpaste on
      halitosis as compared to placebo and to assess potential shifts in the composition of dental
      biofilm associated with the use of curcumin-containing toothpaste

      Participants: This clinical study will 30 adult participants under prophylactic or
      periodontal maintenance protocol.

      Procedures (methods): Participants will be included and throughout the protocol will not
      allow the use any other oral hygiene products except standard manual toothbrush and study
      toothpaste (either test -curcumin-containing or placebo). Additionally participants will be
      instructed to odiferous foods such as onions, garlic and spices. At each of the three
      examination sessions, Plaque Index (six sites, O'Leary) and volatile sulphur compounds (VSC)
      will be measured.
    


Intervention name(s): Toothpaste with curcumin; Toothpaste without curcumin
Intervention type(s): Other; Other
Intervention description(s): Subjects will be given toothpaste to be used during this study with 0.5% curcumin; Subjects will be given toothpaste to be used during this study without curcumin
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Dexmedetomidine on the Characteristics of High Volume/Low Concentration Ropivacaine in a Caudal Block in Pediatrics
Condition: Ambulatory Orchipexy
Study type: Interventional

Summary: 
      The investigators perform this study to evaluate the effects of caudal Dexmedetomidine (DEX)
      added to high volume/low-concentration of ropivacaine in children undergoing orchiopexy.
    


Intervention name(s): Caudal ropivacaine + normal saline; Caudal ropivacaine + dexmedetomidine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dexmedetomidine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: dexmedetomidine; caudal block; children; children (1-6 years) undergoing ambulatory orchipexy
Immune Checkpoint Inhibitors(ICPis)-Induced Endocrine Immune-related Adverse Events (irAEs)
Condition: Immune Checkpoint Inhibitor; Endocrine Toxicity
Study type: Observational

Summary: 
      Immune checkpoint inhibitor (ICI) includes agents that block cytotoxic T-cell-associated
      antigen 4 (CTLA-4), programmed cell death protein 1 (PD-1), and programmed cell death protein
      ligand 1 (PD-L1). Since the FDA-approval of the CTLA-4 inhibitor ipilimumab in 2011, ICI
      drugs have emerged as a powerful new tool in the treatment for several advanced cancers. Now
      indications for ICI have expanded dramatically due to their efficacy and include a wide array
      of cancer types. However, the administration of ICI, whereas, carry the risk of developing
      immune-related adverse events (irAEs) and may lead to serious and even fatal events.
      Endocrine dysfunctions are among the most common irAEs that have been reported in clinical
      trials with ICI, including thyroid dysfunction, hypopituitarism, primary adrenal
      insufficiency (PAI) and insulin-deficient diabetes (ICI-DM). However, it is difficult to
      acquire a complete picture of irAEs from randomized controlled trials (RCTs) due to
      limitations in the study design and realistic practicalities.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged 18 years or older, with cancers who received one dose or more of PD-1/PD-L1
        inhibitors 5 academic centers from June 2018 to March 2021 were included.
School Activity for the Reduction of Distress, Pain and Negative Emotions in Children Experiencing Hospital School
Condition: Hospital School Experience
Study type: Observational

Summary: 
      Aim of present study is to evaluate the efficacy of hospital school experience in the
      reduction of distress, pain and negative emotion in children from 8 to 12 years old,
      hospitalized in oncology and pediatric wards. Investigators also want to explore the ideas
      and opinions of teachers and parents about hospital school service.

      Hypothesis: the investigators expect a reduction in pain, distress and negative emotions.
    

Detailed description: 
      The school service into the hospital was born as an attempt to support emotionally,
      relationally and cognitively the hospitalized children, who have to spend a lot of time
      alone, without being educated by teachers with their classmates. There are not many studies
      in the Italian contest about this issue and with the present study the investigators intended
      to implement the acknowledgement about this theme.

      The principal aim of this study is to explore if the school service reduces negative emotions
      experienced by oncological children as well as perceived pain and distress. To evaluate this
      aims, the investigators organized the study in 3 sections: the first is about the emotions
      experienced by oncological children between 8 and 12 years old, who benefit from the school
      service into the hospital; the second is about their parents' opinions and believes about the
      hospital school service; the third is about opinions, training and educational method
      dedicated by hospital school teachers and not hospital school teachers (who previously
      thought to our oncology children sample).
    

Intervention name(s): Hospital School Experience, point of view of the children; Hospital School Experience, point of view of the hospital teachers; Hospital School Experience, point of view of the non hospital teachers; Hospital School Experience, point of view of parents
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Operators of the PANAS-C, PH-C and VAS ask the children to answer the questionnaire before/after the school lesson; then they ask the children to make 2 paintings about hospital and not hospital school experience.; operators interview hospital teachers and make them complete a questionnaire (CEESQ); operators interview the teachers and make them complete a questionnaire (CEESQ); Operators interview parents
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        children 8-12 years old in oncology and pediatric wards, having hospital school into Meyer
        Hospital; parents of these children; hospital and not hospital teachers of the patients
        included in the study
      
Keywords: hospital school; pain; distress; negative emotions; school continuity; child
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG
      145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein
      cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective
      dose of a statin.
    


Intervention name(s): Evolocumab; Ezetimibe; Placebo to Evolocumab
Intervention type(s): Biological; Drug; Other
Intervention description(s): Administered by subcutaneous injection; Administered orally once a day; Administered by subcutaneous injection
Other intervention name(s): AMG 145; Repatha; Zetia
Intervention MeSH terms: Ezetimibe; Evolocumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Proprotein convertase subtilisin/kexin type 9 (PCSK9); Cholesterol; High Cholesterol; Raised Cholesterol; Elevated Cholesterol; Statin intolerant; Hypercholesterolemia
Khalifa Effectiveness Study
Condition: Total Rupture of the Anterior Cruciate Ligament in the Knee
MeSH terms: Rupture
Study type: Interventional

Summary: 
      The primary hypothesis is that Khalifa's therapy brings additional benefit compared to
      standard therapy (physiotherapy) for patients with a ruptured anterior cruciate ligament
      (ACL).
    

Detailed description: 
      Mohamed Khalifa, a therapist from Hallein (Austria), has been working since 30 years with a
      self-developed manual technique for treating injuries of the musculoskeletal system
      especially of the knee by applying high pressure to the skin in the area of the injury. This
      pressure is applied in various amplitudes and frequencies.

      International top athletes from various disciplines reported a rapid pain relief, and even
      full recovery, immediately after his one hour treatment.

      Prior to the investigators' study, the investigators evaluated one pilot patient with a
      complete ACL rupture after a soccer game with Magnet-Resonance-Imaging (MRI) and clinical
      tests. This patient was physically immobile and reported pain especially when stretching and
      bending the knee. After one hour of treatment from Khalifa the signs of the injury like the
      stretching / bending inhibition and pain were gone immediately. Three months after the
      treatment, an evaluation of the knee with MRI showed an end-to-end continuous ACL with
      homogeneous signal and the clinical tests confirmed the stability of the knee.

      With this study the investigators will evaluate the possibility of influencing the healing of
      a completely ruptured ACL of the knee by one single special local pressure treatment to the
      skin for 60 min.
    

Intervention name(s): Khalifa's therapy; Physiotherapy
Intervention type(s): Other; Other
Intervention description(s): One hour of Khalifa's therapy which is specially applied pressure to the skin; Twelve times standardized Physiotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: ACL; Ligament; Knee
Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy
Condition: Vitreomacular Traction Maculopathy; Eye Diseases
MeSH terms: Eye Diseases; Macular Degeneration
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to evaluate the safety and preliminary efficacy of different
      doses and several exposure times of intravitreal microplasmin in the setting of pars plana
      vitrectomy for vitreomacular traction maculopathy.
    

Detailed description: 
      Study drug will be administered in the mid-vitreous by injection. Patients will be enrolled
      into the cohorts in a sequential dose/time-escalating fashion. To ensure that enrolment is
      evenly balanced across eligible conditions, enrolment of any specific underlying disease type
      into any cohort will be capped at five (5) patients.
    

Intervention name(s): Microplasmin
Intervention type(s): Drug
Intervention description(s): 25ug injected 1 hr prior to PPV, 24 hr and 7 days prior to PPV, 50ug injected 24 hr prior to PPV, 75ug injected 24 hr prior to PPV and 125ug injected 24 hr prior to PPV.
Intervention MeSH terms: Plasminogen
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetic macular edema; macular hole; vitreomacular traction syndrome