bioihbjkbjnl/mcl2 huggingface dataset:
Single-Dose Pharmacokinetics (PK) Study of Novel Neurogenic Compound NSI-189
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a subject single blinded, randomized, placebo-controlled, single dose,
      first-time-in-human study with three or more ascending cohorts.
    

Detailed description: 
      Each subject will undergo Screening (Day -28 to Day -2). Subjects will return to the clinical
      site on Day -1, be admitted to the unit, and eligibility will be reconfirmed. Eligible
      subjects will receive a single dose of investigational medicinal product (IMP, NSI-189
      Phosphate or Placebo) on Day 1 and will be followed for safety and PK until discharge on Day
      3. Subjects who are experiencing any significant AEs that are considered possibly related to
      study drug will be kept at the unit for an additional day (or longer) until the event
      resolves or it is considered medically safe for the subject to be discharged. Subjects will
      have a telephone Follow-up on Day 4 and return to the unit on Day 7 (± 1) for End-of-study.
      Participation of an individual subject may last up to 36 days from the time of Screening
      until the End-of-study.
    

Intervention name(s): NSI-189 Phosphate
Intervention type(s): Drug
Intervention description(s): Once daily oral administration
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neurogenesis; hippocampal stem cells; depression; stroke
A Study to Evaluate the Safety and Reactogenicity of DPX-RSV(A), a Respiratory Syncytial Virus Vaccine
Condition: Respiratory Syncytial Virus
MeSH terms: Virus Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Administration of DPX-RSV(A), a Respiratory Syncytial Virus vaccine containing Respiratory
      Syncytial Virus (RSV) SHe antigen and DepoVaxTM adjuvant to healthy adults ≥50-64 years of
      age.
    

Detailed description: 
      This is a phase 1, First in Humans, randomized (2:2:1) observer blind, controlled, dose
      ranging, multi-arm parallel-group clinical trial in healthy persons 50 to 64 years of age to
      assess the safety and immunogenicity of two dose levels of a novel vaccine formulation
      DPX-RSV(A) consisting of a synthetic Respiratory Syncytial Virus SHe antigen combined with a
      novel adjuvant DepoVaxTM, compared to the antigen combined with the commonly used adjuvant
      Aluminum hydroxide, and to a saline placebo control.

      The study will evaluate two different doses of DPX-RSV(A) and two doses of the RSV SHe
      antigen with aluminum hydroxide (RSV(A)-Alum), and a placebo control. The study is
      randomized, controlled, and observer-blinded in order that allocation to treatment is
      concealed from the investigative team and the participant. The inclusion of comparator groups
      (a placebo control group and the RSV(A)-Alum) allows for estimation of the attributable risk
      of adverse events. Since the study vaccines are not identical in appearance, an unblinded
      study nurse who has no other role in the study will administer the study vaccines.
    

Intervention name(s): DPX-RSV(A); RSV(A)-Alum; Placebo
Intervention type(s): Biological; Biological; Other
Intervention description(s): Prophylactic peptide vaccine targeting RSV will be administered intramuscularly.; Prophylactic peptide vaccine targeting RSV will be administered intramuscularly.; Normal saline (0.9 % sodium chloride) will be administered intramuscularly.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC
      over Placebo SC in Patients With Moderately to Severely Active Ulcerative Colitis
    


Intervention name(s): CT-P13 SC (Infliximab); Placebo SC
Intervention type(s): Biological; Other
Intervention description(s): Subcutaneous injection of CT-P13 SC; Subcutaneous injection of Placebo SC
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
Condition: Active Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment
      regimen of two doses of anifrolumab versus placebo in adult subjects with moderately to
      severely active, autoantibody-positive systemic lupus erythematosus (SLE).
    

Detailed description: 
      This is a Phase 3, multicentre, multinational, randomised, double-blind, placebo-controlled
      study to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of
      anifrolumab versus placebo in subjects with moderately to severely active,
      autoantibody-positive systemic lupus erythematosus (SLE) while receiving standard of care
      (SOC) treatment. The study will be performed in adult subjects aged 18 to 70 years of age.
    

Intervention name(s): Anifrolumab; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Anifrolumab IV administration every 4 weeks from Week 0 to Week 48 for a total of 13 doses; Placebo IV administration every 4 weeks from Week 0 to Week 48
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Active Systemic Lupus Erythematosus
A Study of Mirikizumab (LY3074828) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to explore the safety and tolerability of mirikizumab in
      healthy Japanese and Caucasian participants. The study will also estimate how much
      mirikizumab gets into the blood stream and how long it takes the body to remove it. The study
      is expected to last about 16 weeks for each participant.
    


Intervention name(s): Mirikizumab - IV; Mirikizumab - SC; Placebo - IV; Placebo - SC
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered IV; Administered SC; Administered IV; Administered SC
Other intervention name(s): LY3074828; LY3074828
Intervention MeSH terms: Mirikizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Impact of Clinical Pharmacy Services Provided for Patients With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      Enrolment of clinical pharmacy services in RA patients as a part of health care system has
      been investigated at many studies but not investigated in active RA patients before. This
      study aimed to detect drug therapy-related problems (DTRPs) in active rheumatoid arthritis
      (RA) patients and Investigate the impact of clinical pharmacist interventions on the patient
      clinical outcome and quality of life (QoL). Methods:Prospective, randomized controlled study
      to be carried out at rheumatology outpatient clinic, Ain Shams University Hospitals on 50
      patients with active RA for 6 months.determine if any drug therapy problems are
      present.Develop a plan of care that includes interventions to resolve drug therapy problems,
      achieve goals of therapy, and prevent drug therapy problems. questionnaires was used to
      measure functional status in RA patients using health assessment questionnaire (HAQ) and
      assess self-reported quality of life in patients with (RA) using rheumatoid arthritis quality
      of life questionnaire (RAQOL) and measure adherence using the 4-item Morisky Green Levine
      Medication Adherence Scale and Disease Activity Score-28 was used as an objective method to
      assess RA disease activity.
    


Intervention name(s): pharmaceutical care services
Intervention type(s): Other
Intervention description(s): detection of drug therapy problems and investigation of the impact of clinical pharmacist interventions on the patient clinical outcome and quality of life
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        rheumatoid arthritis patients from outpatient clinics - Ain shams university hospitals
A Phase I Clinical Study on a New Oral Pentamidine Formulation in Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate on the Hepatic Uptake, Pharmacokinetics, Safety
      and Tolerance of a New Oral Pentamidine Formulation in Hepatocellular Carcinoma Subjects
      Undergoing Thermal Ablation
    

Detailed description: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, sequential-group
      administration of a new oral pentamidine formulation to investigate its hepatic uptake,
      pharmacokinetics, safety and tolerance in subjects with hepatocellular carcinoma who
      undergoes thermal ablation procedure
    

Intervention name(s): Oral Pentamidine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Oral pentamidine given at 300 mg, 600 mg, 900 mg or 1200 mg QD x 3 consecutive days; Placebo given at 300 mg, 600 mg, 900 mg or 1200 mg QD x 3 consecutive days
Other intervention name(s): VLX103
Intervention MeSH terms: Pentamidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatocellular carcinoma; Oral Pentamidine; Endo-exonuclease
Oxytocin Infusion and Abdominal Myomectomy
Condition: Oxytocin and Abdominal Myomectomy
Study type: Interventional
Phase: Phase 3

Summary: 
      Objective:To compare oxytocin infusion with control, in patients undergoing abdominal
      myomectomy in terms of mean blood loss.

      Design: Single blinded randomized control trial Setting: Obstetrics and Gynecology
      Department, Military Hospital, Rawalpindi Population: 60 women of ASA class I-II, with
      intramural fibroids, candidate for elective abdominal myomectomy.

      Methods: Women were divided into two groups randomly. In the study group 30 Units of oxytocin
      in 1000 ml normal saline were given during surgery, at the rate of 15units/hour. In control
      group, pure normal saline was given.

      Main outcome measure: Intra-operative blood loss
    


Intervention name(s): oxytocin in abdominal myomectomy
Intervention type(s): Other
Intervention description(s): Women were divided into two groups randomly. In the study group 30 Units of oxytocin in 1000 ml normal saline were given during surgery, at the rate of 15units/hour. In control group, pure normal saline was given
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Leuprorelin Associated With Radiotherapy Versus Leuprorelin Alone in T3 - T4 or pT3 (on Biopsy) N0, M0 Prostate Cancer
Condition: Prostatic Neoplasms, Locally Advanced
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy and safety of combined radiotherapy and
      hormone therapy and hormone therapy alone in the treatment of clinically locally advanced
      prostate cancer (T3-T4 or pT3 on biopsy, N0, M0).
    

Detailed description: 
      The drug being tested in this study is called leuprorelin SR. Leuprorelin SR is being tested
      to treat people who have prostate cancer. This study will look at the overall survival of
      people who take leuprorelin SR in addition to radiation therapy compared to those who take
      only leuprorelin SR.

      The study will enroll approximately 273 patients. Participants will be randomly assigned to
      one of the two treatment groups.

        -  Combined Radiotherapy and Hormone Therapy

        -  Hormone Therapy alone. All participants will receive leuprorelin injection every 3
           months and flutamide tablets thrice daily for first 30 days as part of hormone therapy.
           Participants randomized to combined radiotherapy and hormone therapy group, will also
           receive radiotherapy 70 +/- 4 Gy in 35 fractions at a rate of 5 fractions of 2 Gy per
           week.

      This multi-center trial will be conducted in France and Tunisia. The overall time to
      participate in this study is 8 years. The scheduled duration of hormone therapy was 3 years
      in both arms, with an additional treatment-free follow-up period of 2 years i.e. a total
      follow-up period of 5 years. Post-protocol collection of information relative to survival
      will be performed after the end the 5-year follow-up period.
    

Intervention name(s): Leuprorelin SR; Radiotherapy; Flutamide
Intervention type(s): Drug; Radiation; Drug
Intervention description(s): Leuprorelin SR injection; Radiotherapy 70 +/- 4 Gy; Flutamide tablets
Other intervention name(s): ENANTONE SR
Intervention MeSH terms: Leuprolide; Flutamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Therapy; Radiotherapy
EMD and/or Bone Substitute for the Treatment of Class II Furcations
Condition: Periodontal Disease
MeSH terms: Periodontal Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      To clinically evaluate the treatment of mandibular class II furcation defects with enamel
      matrix derivative (EMD) and/or a bone substitute graft make of beta tricalcium
      phosphate/hydroxyapatite (βTCP/HA).
    

Detailed description: 
      To clinically evaluate the treatment of mandibular class II furcation defects with enamel
      matrix derivative (EMD) and/or a bone substitute graft make of beta tricalcium
      phosphate/hydroxyapatite (βTCP/HA). Forty-one patients, presenting a mandibular class II
      buccal furcation defect, probing pocket depth (PPD) ≥ 4 mm and bleeding on probing, will be
      included. They will be randomly assigned to the groups: 1- EMD (n = 13); 2- βTCP/HA (n = 14);
      3- EMD + βTCP/HA (n = 14). Relative gingival margin position (RGMP), relative vertical and
      horizontal attachment level (RVCAL and RHCAL) and PPD will be evaluated at baseline and 12
      months. The mean horizontal clinical attachment level gain will be considered the primary
      outcome variable.
    

Intervention name(s): EMD; βTCP/HA; Flap access surgery
Intervention type(s): Drug; Device; Procedure
Intervention description(s): During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).; During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland); In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments.
Other intervention name(s): Emdogain; Bone Ceramic®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Regenerative therapy; Randomized clinical trial (RCT); Enamel matrix derivative; Hydroxyapatite-beta tricalcium phosphate; Buccal furcation
An Alternative Approach to Improve Hyperglycemia Among Type 2 Diabetes Patients
Condition: Type2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The study compared the effect of bitter melon intake and moderate exercise on postprandial
      glucose levels as measured by incremental area under the curve (iAUC) in eight patients with
      type 2 diabetes.
    

Detailed description: 
      Background: This study compared the effects of bitter melon intake and moderate-intensity
      physical activity on postprandial glucose responses in type 2 diabetic patients.

      Methods: A total of 8 patients with type 2 diabetes were randomly assigned to two sequences
      (AB, BA) with two treatments (A or B) using a 2 x 2 randomized cross-over design: A) 100 ml
      of bitter melon juice administered 15 minutes prior to the 75-g oral glucose load; B) 30
      minutes walking at moderate-intensity performed 15 minutes after the oral glucose load.
    

Intervention name(s): Bitter melon juice (100 ml); Exercise
Intervention type(s): Dietary Supplement; Behavioral
Intervention description(s): Fresh bitter melon fruits were purchased from certified local groceries. The seeds of bitter melon were removed, and the juice was obtained from the raw fruit using a blender. Every 140 g of bitter melon fruit produced approximately 100 ml bitter melon juice.; The walking exercise was started 15 minutes after the glucose load. Walking speed was determined to elicit 65% of the maximum heart rate (HRmax) during exercise for each participant. HRmax was estimated using the America College of Cardiology prediction model, HRmax=208 - 0.7 × age. All participants wore a heart rate monitor (Polar, Vantage, XL) around the chest to assess exercise intensity. A rate of perceived exertion was assessed every 2 minutes based on the Borg's scale.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Lumbopelvic Manipulation on Hip and Knee Neuromuscular Activity
Condition: Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to determined if a lower back treatment would change the hip and
      knee muscle activities in people with and without anterior knee pain. The investigators
      hypothesized that the lower back treatment may change the hip and knee muscle activities in
      people with anterior knee pain but not in people without anterior knee pain.
    


Intervention name(s): Lumbopelvic manipulation
Intervention type(s): Other
Intervention description(s): High-velocity-low-amplitude thrust manipulation of the lumbopelvic region
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of a Novel Silicone Dressing to Minimize Scar Formation
Condition: Hypertrophic
MeSH terms: Hypertrophy
Study type: Interventional

Summary: 
      Neodyne has developed an investigational dressing for post-operative incision care. Neodyne
      is conducting this research to study whether the investigational dressing, called the Neodyne
      Dressing, can minimize scar formation in a simple manner.
    

Detailed description: 
      It is proposed to study a dressing designed to reduce scarring in post-incision skin tissue.
      It is expected that by managing the incision site during the healing phase, scar formation
      may be minimized.
    

Intervention name(s): embrace device
Intervention type(s): Device
Intervention description(s): Adhesive bandage/dressing intended to minimize scar formation.
Other intervention name(s): Neodyne Device; embrace dressing; Neodyne Dressing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: scar; incision; wound healing; scarring; post-surgical
Alleviating Trunk Low Back Pain, With an Active Medical Device Study (ATLAS)
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the reduction of pain by wearing the ATLAS Medical Device
      in standardized daily activities for patients with Chronic Low Back Pain.

      This is an intervention al non blinded study with a crossover design comparing pain evaluated
      with an Analogue Visual Scale with and without the ATLAS device during 5 standardized daily
      activities.
    

Detailed description: 
      This study aims at assessing pain release by wearing a new medical device (ATLAS) in patients
      affected by chronic low back pain.

      Population: patients with chronic low back pain admitted for a 4 weeks rehabilitation
      program.

      Intervention: active rehabilitation and wearing the ATLAS device 60 min per day. The ATLAS
      study is carried out during the 5 first days of the rehabilitation program.

      Primary outcome: Pain intensity evaluation with a 100 mm Visual Analogue Scale (VAS) during 5
      standardized activities (the most intensive pain during the 5 activities is recorded), with
      and without wearing the ATLAS device.

      Secondary outcome measures: percentage of patients reporting pain decrease of at least 20 mm
      on the 100 mm VAS during the 5 standardized activities with the ATLAs device compared without
      wearing the device. Percentage of relieved patients (percentage of patient reporting pain
      intensity less than 30 mm on the 100 mm VAS with wearing the device). Pain intensity
      evaluated with the 100 mm VAS before and after 60 min of wearing the ATLAS device.

      Randomization: two groups (i.e. group A and B). Primary outcome is evaluated at day 4 and 5,
      with a crossover design (Group A: pain is evaluated during activities with the device at day
      4 and without the device at day 5. Group B: pain is evaluated during activities without the
      device at day 4 and with the device at day 5).
    

Intervention name(s): wearing ATLAS device during evaluation at 4th day; wearing ATLAS device during evaluation at 5th day
Intervention type(s): Device; Other
Intervention description(s): Wearing the ATLAS device 60 min per day during 5 days and evaluation of pain during standardized activities with or without ATLAS Device at the 4th or 5th day of a 4 weeks rehabilitation program.; Wearing the ATLAS device 60 min per day during 5 days and evaluation of pain during standardized activities without ATLAS Device at the 4th or 5th day of a 4 weeks rehabilitation program.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Low back pain; Medical device; Spine; Rehabilitation; Traction