bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Effect of Cyclosporine, a P-Glycoprotein, Breast Cancer Resistance Protein, and Organic-Anion-Transporting Polypeptide Inhibitor, on Pimodivir in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of a single oral dose of cyclosporine on
      the pharmacokinetics of a single oral dose of pimodivir when coadministered to healthy adult
      participants under fasted conditions.
    


Intervention name(s): Pimodivir; Cyclosporine
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be administered pimodivir 600 mg orally as two tablets of 300 mg each.; Participants will be administered cyclosporine 400 mg orally as 4 capsules of 100 mg each.
Other intervention name(s): JNJ-63623872; NEORAL
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Topical Application of Black Pepper Essential Oil and Peripheral Catheter Insertion
Condition: Vein; Spasm; Patient Satisfaction; Nurse Scope, Practice
Study type: Interventional

Summary: 
      The investigators aimed to determine the effects of topical application of black pepper
      essential oil on peripheral intravenous catheter insertion success.This randomized controlled
      trial was carried out on 60 patients randomly assigned to either the experimental group
      (n=30) or the control group (n=30) reporting to the endoscopy unit of the clinic between May
      2019 and October 2019. In the experimental group, black pepper essential oil was used to
      increase vein degree before the procedure, while in the control group, no extra interventions
      were applied. The time taken in determining an appropriate vein, time taken for successful
      catheter insertion, and the patient's and nurse's satisfaction after the process were
      recorded.
    

Detailed description: 
      Introduction: The literature describes many techniques to increase vein visibility and
      palpability that facilitate peripheral intravenous catheter insertion. However, there is only
      one study examining the effect of topical essential black pepper oil on veins. The
      investigators aimed to determine the effects of topical application of black pepper essential
      oil on peripheral intravenous catheter insertion success.

      Methods: This randomized controlled trial was carried out on 60 patients randomly assigned to
      either the experimental group (n=30) or the control group (n=30) reporting to the endoscopy
      unit of the clinic between May 2019 and October 2019. The study results were evaluated using
      an information form, a catheter insertion form, and a visual analog scale (VAS). In the
      experimental group, black pepper essential oil was used to increase vein degree before the
      procedure, while in the control group, no extra interventions were applied. The time taken in
      determining an appropriate vein, time taken for successful catheter insertion, and the
      patient's and nurse's satisfaction after the process were recorded via a chronometer.
    

Intervention name(s): Topical essential oil application
Intervention type(s): Other
Intervention description(s): We applied black pepper essential oil to the participants in experimental group before the catheter insertion procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: essential oil application; catheter insertion
A 6-week Open Label Cross-over Study With 2 Different Daily Doses of Minirin® Oral Lyophilisate in Children and Adolescents With Primary Nocturnal Enuresis (PNE)
Condition: Primary Nocturnal Enuresis
MeSH terms: Enuresis; Urinary Incontinence; Nocturnal Enuresis
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the preference of subjects for Minirin® oral lyophilisate treatment compared with
      Minirin® tablet treatment after 6 weeks.

      To compare efficacy of the 2 formulations at the end of the 6-week treatment period using
      diary card data.

      To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale. To validate a
      PNE Quality of Life (QoL) questionnaire. To evaluate safety. To compare compliance with the 2
      formulations
    

Detailed description: 
      To evaluate the preference of subjects for Minirin® oral lyophilisate treatment compared with
      Minirin® tablet treatment after 6 weeks.

      To compare efficacy of the 2 formulations at the end of the 6-week treatment period using
      diary card data.

      To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale. To validate a
      PNE Quality of Life (QoL) questionnaire. To evaluate safety. To compare compliance with the 2
      formulations
    

Intervention name(s): MINIRIN Oral Lyophilisate; Minirin tablet
Intervention type(s): Drug; Drug
Intervention MeSH terms: Deamino Arginine Vasopressin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Family & Friends - the Significance of a Significant Other in Treatment
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study focuses on the difficulties to maintain a weight loss and behavioural change after
      having been in a institutional intermittent weight loss programme.

      We explore if including a member of the family or a close friend in the treatment influences
      weight loss maintenance after completion of the programme.
    


Intervention name(s): With friend; Without friend
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Weight Loss; Social support
SAD and MAD Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of TD-1473 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      single ascending doses and multiple ascending doses of the investigational drug TD-1473
      compared to placebo in healthy subjects.
    


Intervention name(s): TD-1473 for SAD; Placebo for SAD; TD-1473 for MAD; Placebo for MAD
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): SAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 5 dose ascending cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally as a single dose.; SAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 5 dose ascending cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally as a single dose.; MAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 4 cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally for a total of 14 days of dosing.; MAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 4 cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally for a total of 14 days of dosing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Single ascending dose; SAD; multiple ascending dose; MAD; Phase 1; first-in-human; volunteers; TD-1473
An Investigation of rhTPO With Different Frequencies in the Management of ITP
Condition: Immune Thrombocytopenia
MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 3

Summary: 
      The project was undertaking by Qilu Hospital of Shandong University and other well-known
      hospitals in China. In order to study the efficacy and safety of different dose and frequency
      Recombinant Human thrombopoietin in treating the primary immune thrombocytopenia (ITP)
    

Detailed description: 
      The investigators are undertaking a parallel group, multicentre, randomised controlled trial
      of 30 primary ITP adult patients from 3 medical centers in China. They will be randomly
      assigned in a 1:1:1 ratio into three groups .The patients in group A (total 10 patients) will
      receive rhTPO at a dose of 300Units/kg ,daily for 14 consecutive days;The patients in group B
      will receive rhTPO at a dose of 300Units/kg ,one times every other day for 7 times.The
      patients in group C will receive rhTPO at a dose of 300Units/kg ,daily for 7 consecutive days
      .All the patients will follow with a flexible dosage depending on platelet count during the
      following 12 weeks.

      Platelet counts, bleeding and other symptoms were evaluated before and after treatment, in
      order to evaluate the efficacy and safety of different dose and frequency Recombinant Human
      thrombopoietin in treating the primary immune thrombocytopenia (ITP)
    

Intervention name(s): Recombinant Human Thrombopoietin (rhTPO)
Intervention type(s): Drug
Intervention description(s): rhTPO was given intravenously at a dose of300Units/kg ,daily for 14 consecutive days;at a dose of 300Units/kg ,one times every other day for 7 times; or at a dose of 300Units/kg ,daily for 7 consecutive days
Other intervention name(s): tpiao; Recombinant Human Thrombopoietin; Recombinant Human TPO
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recombinant Human Thrombopoietin; Dose and frequency; Immune Thrombocytopenia
A Stress Reduction Program for Companies
Condition: Stress
Study type: Interventional

Summary: 
      This protocol proposes a well-being program based in stress reduction program for employees
      of a company.

      objectives: To evaluate the effects of a stress reduction program with a specific orientation
      for workers and taught to them within their companies.

      Methods: Participants with stress complaints were recruited and randomized into two groups:
      group 1 (G1) received the intervention while group 2 (G2) did not. Both groups were evaluated
      before the intervention (time 1 - T1); again after the eight weeks of the program for G1
      (time 2 - T2); and then at the end of a second eight-week period during which G2 received the
      intervention and G1 was simply instructed to maintain the practice they had learned without
      further instruction (time 3- T3).
    

Detailed description: 
      Disorders resulting from chronic stress are some of the main causes of absenteeism and
      reduced productivity in companies. A number of successful stress management programs are
      based on the principle of mindfulness and may help individuals to relieve stress symptoms and
      to improve well-being and pro-social behavior. The objective of this study was to evaluate
      the feasibility and efficacy of a weekly one-hour stress reduction program adapted for
      companies and if the possible benefits would be sustained 8 weeks after the end of the
      program. Participants with stress complaints were recruited in two companies and they were
      randomized into two groups: in the first period of the study, group 1 (G1) N=23 received the
      intervention while group 2 (G2) N=18 did not. Both groups were evaluated before the
      intervention (time 1 - T1); again after the eight weeks of the program for G1 (time 2 - T2);
      and then at the end of a second eight-week period during which G2 received the intervention
      and G1 was simply instructed to maintain the practice they had learned without further
      instruction (time 3- T3).
    

Intervention name(s): PROGRESS group
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stress; work; employees; mindfulness; depression; anxiety
A Single Blind, Randomized, Placebo-controlled, Phase 2a, 2-cohort Study for the Evaluation of Safety and Efficacy of RZL-012 for Submental Fat Reduction in Healthy Volunteers.
Condition: Submental Fat
Study type: Interventional
Phase: Phase 2

Summary: 
      Twenty-Eight (28) subjects (12 for cohort 1 and 16 for cohort 2 ) will be included in the
      study. Subjects in each cohort will be injected with a different dose of RZL-012. The total
      of 28 subjects will be enrolled in 2 clinical sites.
    

Detailed description: 
      This is a single blinded, randomized, placebo-controlled, 2-cohort clinical study in healthy
      volunteers. Cohort 1 will be comprised of 8 active (RZL-012) and 4 placebo subjects. Cohort 2
      will be comprised of 16 subjects wuth at least 4 placebo subjects. All subjects will receive
      a single dose of RZL-012 or vehicle into the submental area, after which they will be
      monitored for safety and efficacy during 84 days of follow-up.

      Subjects will be blinded to study treatment while physicians will not be blinded.

      The study will be composed of 2 treatment cohorts, 12 in cohort 1 and 16 in cohort 2.

      The study will be conducted in 2 clinical sites. Per each study cohort, subjects will be
      randomized to receive active or placebo treatment according to a randomization program that
      will be prepared prior to study initiation. Each clinical site will have at least one active
      and one placebo treatment subject per each study cohorts. In case of slow enrollment in one
      of the sites, other sites may complete the enrollment of subjects in each cohort.

      Cohort 1 (N=12) - Each subject will be dosed with up to 120 mg RZL-012 (depending on
      submental fat area) or vehicle.

      Cohort 2 (N=16) - Each subject will be dosed with up to 240 mg RZL-012 (depending on
      submental fat area) or vehicle.

      Treatment of cohort 2 will start following cohort 1 day 28 data. An independent Data Safety
      Monitoring Board (DSMB) will review safety and tolerability data for cohort 1 subjects, 28
      days after injection, and decide whether it is safe to increase the dose for the next study
      cohort. The decision to proceed to the cohort 2 will be made within 30 days (28 days + 2
      days) after injection of the last dosed subject in cohort 1.

      The DSMB will be comprised of two independent MDs with expertise in the aesthetic area and in
      conduction of clinical trials.

      In case of serious safety concerns (e.g. prolonged severe swelling or severe pain following
      injection) among cohort 1 subjects receiving the 120mg dose, sponsor and DSMB may decide to
      reduce or stay with the 120mg/subject dose level for cohort 2 subjects.
    

Intervention name(s): RZL-012; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection to the submental fat area; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effects of Preoperative Dexamethasone Study on QOL After Vaginal Reconstructive Surgery for POP
Condition: Pelvic Organ Prolapse; PONV
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators hypothesize that preoperative administration of 8 mg IV dexamethasone will
      benefit patients' perceived quality of recovery after surgery.
    

Detailed description: 
      This is a randomized controlled trial involving single administration of 8 mg Dexamethasone
      per IV preoperatively among women undergoing vaginal reconstructive surgery for pelvic organ
      prolapse.
    

Intervention name(s): Dexamethasone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dexamethasone 8mg/IV; Placebo given IV
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: pelvic organ prolapse surgery; dexamethasone; postoperative nausea and vomiting; peroperative administration
Tension Band Wiring Versus Cannulated Screws in Fixation of Medial Malleolus in Ankle Fracture
Condition: Medial Malleolus Fracture
MeSH terms: Fractures, Bone; Ankle Fractures
Study type: Interventional

Summary: 
      This is a prospective randomized study conducted on 30 patients with an age spanning between
      20 and 55 years. Half of the sample was treated by tension band wiring for closed medial
      malleolar fractures, and the other half by two cannulated screws. The patients were assessed
      at (6w-3months and 6months) for clinical and radiological union and evaluated functionally
      (12 months) using modified Olerund and Molander scoring system.
    


Intervention name(s): Tension band wires; Cannulated screws
Intervention type(s): Procedure; Procedure
Intervention description(s): medial malleolus fracture fixed with tension band wiring): 2 k.wires (1.6 mm) are inserted perpendicular to the fracture site. Again the position is checked under image intensification for the correct direction and length. We drilled a 2.5mm hole with a protection sleeve, 2-3cm above the level of the horizontal joint line, aiming the drill bit slightly inferiorly to avoid screw pullout. We inserted a 3.5mm unicortical screw about 30 mm in length (with or without washer), 2-3mm is left for the wire between the bone and screw head before full tightening. A steel wire is constructed into a figure of eight between the screw the reduction k. wires, then twisted to achieve interfragmentary compression; In group 2 (15 patients with medial malleolus fixed by 2 cannulated screws): Two guide wires (1.6mm) are inserted perpendicular to the fracture site, the appropriate length, proper insertion site including the distance from the articular surface is checked fluoroscopically .the length is measured .drilling of the bone through the threaded guide wire with a cannulated drill bit (3.2mm). A two 4.5mm partially threaded cannulated screws (with or two washers) are inserted through the guide to achieve Compression, the guide wires are then removed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fixation of medial malleolus; Tension band; Malleolus fracture; Ankle fracture
Vidofludimus Calcium for Primary Sclerosing Cholangitis
Condition: Primary Sclerosing Cholangitis
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Study type: Interventional
Phase: Phase 2

Summary: 
      To examine the safety, tolerability, and efficacy of daily dosing with vidofludimus calcium
      over a 6-month period.
    

Detailed description: 
      Investigators will assess the following:

        1. Changes on serum alkaline phosphatase levels at 3 & 6 months.

        2. Changes in other liver biochemistries at 3 & 6 months.

        3. Changes in IL-17 &IFNγ levels at 6 weeks and 6 months.
    

Intervention name(s): Vidofludimus calcium
Intervention type(s): Drug
Intervention description(s): During the 6-month treatment period, subjects will receive 30 mg VC orally once daily. This will be preceded by a lead-in dosing period where subjects will receive 15 mg VC once daily for 1 week.
Other intervention name(s): IMU-838
Intervention MeSH terms: Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase I, Open-Label, Multicentre Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MEDI4736 in Patients With Advanced Solid Tumours
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, open-label, multicentre study of MEDI4736 administered intravenously with
      a standard 3+3 dose-escalation phase to evaluate safety, tolerability, and pharmacokinetics
      in patients with advanced solid tumor followed by an expansion phase in patients with
      advanced solid tumors.
    


Intervention name(s): MEDI4736; tremelimumab
Intervention type(s): Drug; Drug
Intervention description(s): MEDI4736 will be administered by IV infusion every 14, 21 or 28 days.; tremelimumab is administered by IV infusion every 4 weeks
Intervention MeSH terms: Durvalumab; Tremelimumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MEDI4736; Advanced solid tumors; squamous cell carcinoma of the head and Neck; biliary tract cancer; squamous cell carcinoma of esophagus cancer; B7-H1; PD-L1
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of TAK-925 after a single intravenous
      dose (compared to placebo) on promoting wakefulness as measured by sleep latency on the
      maintenance of wakefulness (MWT) in sleep-deprived healthy participants.
    

Detailed description: 
      The drug being tested in this study is called TAK-925. This study will assess the safety,
      tolerability, PK and PD of TAK-925 and will assess the effects of TAK-925 in sleep-deprived
      healthy adult participants.

      The study will enroll approximately 20 participants. Participants will be randomly assigned
      (by chance, like flipping a coin) to one of the 4 treatment sequences-which will remain
      undisclosed to the participant and study doctor during the study (unless there is an urgent
      medical need):

        -  TAK-925 Low Dose + Placebo + TAK-925 High Dose + Modafinil

        -  TAK-925 High Dose + TAK-925 Low Dose + Modafinil + Placebo

        -  Modafinil+ TAK-925 High Dose + Placebo + TAK-925 Low Dose

        -  Placebo + Modafinil + TAK-925 Low Dose + TAK-925 High Dose

      TAK-925 will be administered as an intravenous infusion based on the availability of safety,
      tolerability and PK data from health Japanese participants in ongoing study TAK-925-1001.

      This single center trial will be conducted in the United States. The overall time to
      participate in this study is approximately 10 weeks. Participants will make a final visit 7
      days after receiving their last dose of drug for a follow-up assessment.
    

Intervention name(s): TAK-925; TAK-925 Placebo; Modafinil; Modafinil Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): TAK-925 intravenous infusion.; TAK-925 placebo-matching given as saline intravenous infusion.; Modafinil tablets.; Modafinil placebo-matching tablet.
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Drug Therapy