bioihbjkbjnl/mcl2 huggingface dataset:
Phase I Study to Assess the Effect of Food on AZD1775 Pharmacokinetics in Patients With Advanced Solid Tumours
Condition: Solid Tumours
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of food on the pharmacokinetics (PK) of a
      single dose of AZD1775 (printed capsules) in patients with advanced solid tumours.
    

Detailed description: 
      This is a Phase I, open-label, randomised, 2-period crossover design study in patients with
      advanced solid tumours.

      The purpose of this study is to assess the effect of food on the pharmacokinetics (PK) of a
      single dose of AZD1775 (printed capsules).In addition single dose safety and tolerability
      data will be gathered.

      Patients will be screened within 28 days of Day 1 of the first treatment period (Period 1).
      Patients will take part in 2 randomised treatment sequences each separated by a washout
      period of at least 5 and no more than 14 days.

      During Period 1, prior to administration of the first dose of study treatment, each patient
      will be randomised to 1 of 2 treatment sequences (Fasted-Fed or Fed-Fasted) to receive a
      single oral dose of 300 mg AZD1775 in each of the 2 treatment periods as follows:

        -  Fasted (Treatment A): Single dose 300 mg AZD1775, (3 x 100 mg, printed capsules).

        -  Fed (Treatment B): Single dose 300 mg AZD1775, (3 x 100 mg, printed capsules).

      Pharmacokinetic and safety assessments will be obtained for up to 72 hours post-dose in each
      treatment period.

      On completion of the study (ie, after collection of 72-hour PK sample and safety in period 2)
      patients will be evaluated per current assessments for their eligibility and interest to
      enrol into the open-label continued treatment access study (D6014C000007).
    

Intervention name(s): Treatment A - AZD1775 administered under fasted conditions; Treatment B - AZD1775 administered under fed conditions.
Intervention type(s): Drug; Drug
Intervention description(s): Premedication with Kytril (granisetron) 1 mg intravenously or Zofran (ondansetron) 8 mg intravenously within 30 to 40 minutes prior to administration of the AZD1775 capsules. Single dose 300 mg AZD1775, (3 x 100 mg, printed capsules) administered orally under fasted conditions. The drug class of AZD1775 is Wee-1 kinase inhibitor.; Premedication with Kytril (granisetron) 1 mg intravenously or Zofran (ondansetron) 8 mg intravenously within 30 to 40 minutes prior to administration of the AZD1775 capsules.
Single dose 300 mg AZD1775, (3 x 100 mg, printed capsules) administered orally under fed conditions.
The drug class of AZD1775 is Wee-1 kinase inhibitor.
Intervention MeSH terms: Adavosertib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics, WEE1 inhibitor, food effect, safety assessments
Clinical Investigation to Examine Toothpaste Effect on Oral Bacteria
Condition: Oral Bacteria Levels in the Mouth
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective was to evaluate the antibacterial effects of two toothpastes containing
      0.3% triclosan, 2% copolymer and 0.234% sodium fluoride in a silica base as compared to a
      control regular fluoride toothpaste on anaerobic and malodor bacteria 12 hours after 13 days
      of product use. A secondary objective was to demonstrate that a toothpaste containing 0.3%
      triclosan, 2% copolymer, 0.234% sodium fluoride and a flavor with odor-masking ingredients in
      silica base (Colgate Total Toothpaste-Flavor Option 1) provides a level of antibacterial
      efficacy that is "equivalent" to a toothpaste containing 0.3% triclosan, 2% copolymer, 0.234%
      sodium fluoride and a regular flavor in silica base (Colgate Total Toothpaste-Flavor Option
      2) after 13 days of product use.
    


Intervention name(s): Total Flavor option 1; Total Flavor option 2; Placebo toothpaste: Crest Cavity Protection toothpaste
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1; Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2; Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)
Other intervention name(s): Total toothpaste; Total toothpaste; Crest Anti-Cavity toothpaste
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Docetaxel and Cisplatin in Patients With Solid Tumors
Condition: Neoplasms, Malignant
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

        -  To determine the maximum tolerated dose based on the incidence of dose limiting toxicity
           and the maximum administered dose of ombrabulin in combination with docetaxel and
           cisplatin administered every 3 weeks in patients with advanced solid tumors

      Secondary Objectives:

        -  To assess the overall safety profile of the combination therapy

        -  To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR
           258063, docetaxel and cisplatin in combination.

        -  To evaluate anti-tumor activity of the combination therapy
    

Detailed description: 
      The duration of the study for each patient will include an up to 4-week screening phase,
      21-day study treatment cycles, an end of treatment visit and a follow-up period 30 days after
      the last infusion of ombrabulin. The patient will continue treatment until disease
      progression, unacceptable toxicity, patient's refusal of further treatment.
    

Intervention name(s): OMBRABULIN (AVE8062); cisplatin; docetaxel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form:injection solution
Route of administration: intravenous infusion; Pharmaceutical form:injection solution
Route of administration: intravenous infusion; Pharmaceutical form:injection solution
Route of administration: intravenous infusion
Intervention MeSH terms: Docetaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Do Changes in Plasma Osmolality Influence Ventilation?
Condition: Hyponatraemia; Hypernatraemia
MeSH terms: Hyponatremia; Hypernatremia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Primary hypothesis: osmolality changes influence the sensitivity of the respiratory center to
      carbon dioxide, hyponatraemia causing hyperventilation, and hypernatraemia depressing
      ventilation.

      Secondary hypothesis: There are gender differences in the sensitivity to osmolality changes.

      10 women and 10 men will on different occasions drink water or receive hypertonic saline
      intravenously, in order to lower or increase plasma osmolality. The women will participate
      during both faces of the menstruation cycle. On each occasion the subject´s sensitivity to
      carbon dioxide will be tested, and blood samples will be drawn for analysis of blood
      gases,electrolyte and osmolality.Subjects who interrupt participation before completion of
      all planned occasions, will be substituted, so that 10 subjects of either sex will have
      participated as planned. All results from all participants will be analyzed.
    

Detailed description: 
      Healthy volunteers will on different occasions be subject to reduced plasma osmolality caused
      by drinking water, and increased osmolality caused by intravenous infusion of hypertonic
      saline.Before and after each osmolality change, sensitivity to carbon dioxide will be tested
      by partial rebreathing through a so called Bain-system. Throughout the whole experiment heart
      rate, blood pressure and oxygen saturation will be recorded.Blood samples will be collected
      before each rebreathing test and every 20 minutes during the two hours of water or salt load.
      Urine will be collected and analysed.
    

Intervention name(s): Water; Saline 3%
Intervention type(s): Other; Other
Intervention description(s): The subjects will drink tap water for 2 hours, volume calculated according to weight: 20ml/kg/hour.; The subjects will receive saline 3% intravenously for 2 hours, the volume calculated as 0.1 ml/kg/min
Other intervention name(s): saline 3%
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: carbon dioxide; ventilation; gender; osmolality; menstruation cycle
Effects of Two-weeks of Time Restricted Feeding on Basal and Postprandial Metabolism in Healthy Men
Condition: Metabolic Health
Study type: Interventional

Summary: 
      In the modern era, food access is widely available and it is not uncommon for the time
      between breakfast and a late night snack to exceed 14 hours. The investigators are interested
      in studying whether limiting this window to 8 hours will have any beneficial effects of human
      health as has been demonstrated in animal models. Eight men were asked to restrict their
      energy intake window to between 8 am and 4 pm for two weeks whilst maintaining their habitual
      diet (quantity and composition). Improvements in skeletal muscle and whole-body insulin
      sensitivity were observed but these were potentially confounded by an average weight loss of
      1 kg. Therefore an additional control group was recruited to follow a daily caloric deficit
      of ~400 kilocalories without changing the timing of intake.
    

Detailed description: 
      All participants were monitored for a one week baseline period to establish their habitual
      physical activity and dietary patterns. This was done using food diaries, interstitial
      glucose monitors and a combined heart rate + accelerometer device. Participants consumed a
      standardised evening meal ~12h before visiting the laboratory to assess their metabolic
      response to a liquid test meal (1g/kg bodyweight dextrose and 0.4g/kg bodyweight protein)
      using the arterio-venous forearm balance model. Dual-energy X-ray absorptiometry scans,
      indirect calorimetry measurements and fasted and postprandial vastus lateralis biopsies were
      also obtained.

      From the next day, participants either restricted their daily energy intake window to between
      8 am and 4 pm or were prescribed a caloric deficit diet (~400 kilocalories/day) for two
      weeks. Physical activity, interstitial glucose concentrations and dietary patterns were
      monitored throughout. After this, participants visited the laboratory again to assess changes
      in metabolism and body composition.
    

Intervention name(s): Time restricted feeding; Caloric restriction
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Restrict energy intake window to between 8am and 4pm; Follow a prescribed daily energy deficit of 400 kilocalories without altering nutrient timing
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: All participants monitored for a one week baseline period before being allocated to either a caloric deficit group or a time-restricted feeding group for two weeks.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: chrononutrition; metabolism; body composition
Effectiveness of Laserpuncture and Standard Antiemetic on RINVR Scores in Adolescent Patients Undergoing Chemotherapy
Condition: Chemotherapy-induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Study type: Interventional

Summary: 
      Chemotherapy is a common treatment for treating cancer. Chemotherapy induced nausea and
      vomiting (CINV) is nausea and vomiting that occurs after chemotherapy. Complete protection of
      standard antiemetic drugs against CINV symptoms in children and adolescents receiving
      moderately and strongly emetogenic chemotherapy drugs was less than 50%.

      The side effects of chemotherapy in the form of CINV are so unpleasant that chemotherapy
      causes extreme anxiety and stress. The psychological characteristics of adolescents who have
      a greater perception of the changes that occur cause more frequent anxiety which can increase
      the risk of CINV.

      Acupuncture with laserpuncture modality is a non-pharmacological therapy that has a good
      effect on CINV symptoms in adolescents. This research was conducted for the first time in
      Brazil in 2019, while in Indonesia there has never been any research on this matter. So it is
      hoped that this research will be the first research in Indonesia to prove that the effect of
      laserpuncture plays a role in CINV symptoms in adolescents and can be an additional treatment
      in standard therapy for CINV problems in adolescents.
    

Detailed description: 
      This is a clinical trial study to evaluate and compare the effects of laserpuncture and sham
      laserpuncture as a therapy for Chemotherapy induced nausea and vomiting (CINV) . The subjects
      are 58 males/female and will be randomly assigned to 2 groups: (1) laserpunctur and (2) Sham
      laserpuncture. The outcome will be assessed before treatment (baseline), in chemotherapy
      procedure and 3 days after chemotherapy. Patients and the outcome assessors will be blinded
      to the group allocation.
    

Intervention name(s): laserpuncture; Sham Laserpuncture
Intervention type(s): Device; Device
Intervention description(s): laserpuncture use continous wave,dose 2 Joule, 785nm, 50mw; Sham laser using laserpuncture in off condition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Study to Test the Effectiveness of Controlled-Release OROS® Hydromorphone HCl Compared to Placebo in Patients With Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will test an experimental drug called OROS® hydromorphone hydrochloride (HCl)
      (NMED-1077), a once daily opioid analgesic that can relieve pain. A large number of clinical
      studies have been conducted to test this drug. OROS hydromorphone HCl is currently approved
      in both the US and Europe to treat chronic pain.

      The purpose of this study is to compare OROS hydromorphone to placebo to see if it is safe
      and efficacious.
    


Intervention name(s): OROS hydromorphone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): hydromorphone 12, 16, 24, 32, 40, 48, or 64 mg tablets; Placebo
Intervention MeSH terms: Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Back Pain; Chronic Low Back Pain; Chronic Back Pain; Pain; Chronic Pain
Effects of Docosahexaenoic Acid (DHA) on Cardiovascular Disease on Diabetic Patients
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      Aim: to determine the effects of DHA supplementation:

        -  on the platelet function through their aggregation and the pathway of arachidonic acid
           metabolism

        -  on redox status on cells and plasma

        -  on inflammation in 16 type 2 diabetic patients in a cross-over study comparing DHA (400
           mg/day for 2 weeks) vs Sunflower oil (placebo). Each period is separated by a wash-out
           period of 6 to 9 weeks.
    


Intervention name(s): First period DHA; Second period DHA
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 400 mg DHA supplementation by day for 2 weeks during the first study period; 400 mg DHA supplementation by day for 2 weeks during the second study period
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: DHA supplementation; Type 2 diabetic patient; Platelet function
Evaluation of Navigation Assisted Reconstruction of Posttraumatic Zygomatic Deformity
Condition: Zygomatic Fractures
MeSH terms: Zygomatic Fractures
Study type: Interventional
Phase: Phase 3

Summary: 
      Treatment of late deformities following fractures of the orbitozygomaticomaxillary complex
      can be considered a formidable challenge, even to the skilled surgeon. However, the
      development of Computer-Assisted Navigation technology Offers new opportunities in the
      treatment of such deformities. With the help of navigation system,pre- and
      intraoperatively,the objective of any supporting medical device for reconstruction of the
      orbitozygomaticomaxillary complex would be visualization of the real and desired positions of
      the zygoma. In this randomized controlled trial, the investigators would like to evaluate the
      feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in
      cases of established post-traumatic deformities using computer assisted navigation.
    

Detailed description: 
      Treatment of late deformities following fractures of the orbitozygomaticomaxillary complex
      can be considered a formidable challenge. Even to the skilled surgeon, over-or
      underestimation of the displacement is likely to occur, leading to an unsatisfactory result
      caused by over- or undercorrection.However,The development of Computer-Assisted Navigation
      technology Offers new opportunities in the treatment of such deformities. With the help of
      navigation system,pre- and intraoperatively,the objective of any supporting medical device
      for reconstruction of the orbitozygomaticomaxillary complex would be visualization of the
      real and desired positions of the zygoma. In this randomized controlled trial, we would like
      to evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic
      osteotomies in cases of established post-traumatic deformities using computer assisted
      navigation.
    

Intervention name(s): Navigation Surgery; Traditional Surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): To evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in cases of established post-traumatic deformities using computer assisted navigation.; To compare with the experamental group.
Other intervention name(s): Computer-Aided Surgery; Surgical Navigation; Control Group
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Zygomatic Fractures; Surgery, Computer-Assisted; Facial Asymmetry
Pharmacodynamic Effects, Safety and Tolerability of Cilobradine, Compared to Metoprolol Succinate and Placebo in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Pharmacodynamic effects on heart rate (HR) at rest and during exercise and on flicker fusion
      frequency (FFF), FFF method evaluation

      Safety, tolerability and pharmacokinetics of cilobradine
    


Intervention name(s): Cilobradine low dose 1; Cilobradine low dose 2; Cilobradine medium dose; Cilobradine high dose 1; Cilobradine high dose 2; Metoprolol succinate tablets; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Metoprolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
INSTRUCT for Repair of Knee Cartilage Defects
Condition: Articular Cartilage Lesion of the Knee
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether the INSTRUCT therapy is safe and
      effective in the treatment of cartilage defects of the knee.
    

Detailed description: 
      This is a prospective, open-label, single-arm pilot study designed to investigate the safety
      and efficacy of the INSTRUCT therapy in the treatment of knee cartilage defects.

      All patients who meet eligibility criteria and who consent to participate will undergo the
      implantation of a biodegradable scaffold seeded with autologous primary chondrocytes and bone
      marrow cells via arthrotomy.

      Patients will be followed-up for 2 years at regular intervals. Evaluations will include
      adverse events collection, patient reported outcomes (mostly pain and function), arthroscopic
      and histologic evaluations and MRIs (including dGEMRIC).
    

Intervention name(s): INSTRUCT
Intervention type(s): Device
Intervention description(s): INSTRUCT PolyActive scaffold implantation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: knee cartilage defect repair; cartilage lesion; autologous chondrocyte; scaffold; INSTRUCT
Characteristics of Intensity and Dependence to Physical Activity in Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Observational

Summary: 
      Etude d'épidémiologie clinique multicentrique (IMM), naturalistique, comparant un échantillon
      clinique à un échantillon de témoins issus de la population générale.

      Cette recherche se fixe pour objectif principal de déterminer, sur un large échantillon de
      patients pris en charge pour anorexie mentale dans des unités de soins spécialisées, les
      caractéristiques de l'activité physique et la dépendance à l'exercice physique en comparaison
      avec des sujets issus de la population générale appariés pour l'âge et le sexe.

      Nous faisons l'hypothèse que les patients anorexiques mentaux sont plus actifs et plus
      dépendants à l'exercice physique que des sujets de la population générale de même âge et de
      même sexe.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pour l'échantillon clinique (patients témoins et contrôles) : prise en charge pour Anorexie
        Mentale (selon les critères DSM-IV) dans le département de psychiatrie de l'enfant et de
        l'adolescent de l'Institut Mutualiste Montsouris.

        Pour l'échantillon individus sains témoins : Sujets issus de la population générale
        (collégiens lycéens étudiants).
Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19
Condition: Confirmed Coronavirus Disease
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to evaluate if adding rhC1-INH to standard of care (SOC)
      in patients admitted for stage II COVID-19 infection may reduce the risk of disease
      progression, i.e. ALI requiring mechanical ventilation, or increase the chance of a faster
      clinical improvement compared to SOC alone.
    

Detailed description: 
      Patients fulfilling all eligibility criteria will be randomized in a 2:1 ratio in an
      open-label controlled design to treatment with rhC1-INH in addition to SOC or SOC only
      starting on day 0. The first rhC1-INH treatment will be administered on the same day and
      continued for a total of 4 days.
    

Intervention name(s): Ruconest
Intervention type(s): Drug
Intervention description(s): Patients will be randomized to Ruconest or Standard of Care
Other intervention name(s): SOC
Intervention MeSH terms: Complement C1 Inhibitor Protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment