bioihbjkbjnl/mcl2 huggingface dataset:
PK Study of Multi-dose Trazodone Hydrochloride Prolonged-released Tablets in Healthy Chinese
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective is to evaluate the pharmacokinetics comparative studies in a single dose,
      multiple dose
    

Detailed description: 
      Trial II Multiple dose, the highest specification (150mg) pharmacokinetic study of Trazodone
      Hydrochloride Prolonged Release Tablets; 12 patients (males and females, half and half).

      2-period, 2 cross (2x2) crossover design was used. screened 12 subjects (males and females)
      were randomly divided into two groups (II-1、II-2), each 3 males and 3 females, give the
      following two different crossover treatments: trazodone hydrochloride prolonged-release
      tablets 150 mg per day for 7 days in T group, trazodone hydrochloride tablets 50mg for 3
      times per day for 7 days in R group. Wash-out period is 14 days.

      Trial II. 2X2 design Group Period 1 Period 2 II -1 R T II -2 T R T group: the subjects will
      be provided trazodone hydrochloride prolonged-release tablet 150mg at about8:00am each day.
      Sampling site will be conducted in day 1, 5, 6, 7 before administration in this period, blood
      sampling will be conducted in 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0,
      36.0, 48.0, 72.0h after administration on day 7.

      R group: The subjects will receive 50mg trazodone hydrochloride tablet 50mg for 3 times after
      receiving standard light breakfast at 6:00am, standard meal at 14:00 and 22:00. Blood
      sampling will be conducted on day 1, 5, 6, 7 before first administration in this period,
      blood sampling will be conducted at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0 (before the second
      time administration), 8.5, 9.0, 9.5, 10.0, 11.0, 12.0, 14.0, 16.0 (before the third time
      administration), 16.5, 17.0, 17.5, 18.0, 19.0, 20.0, 22.0, 24.0, 36.0, 48.0, 72.0h after
      administration on day 7.

      5.0 mL venous blood from forearm venous blood was took through venous indwelling needle and
      transfer into the heparin tube. After plasma separation it stored in low temperature in a
      refrigerator.
    

Intervention name(s): trazodone hydrochloride prolonged-release tablet; trazodone hydrochloride tablet
Intervention type(s): Drug; Drug
Intervention description(s): 150 mg, oral administration, 1 per day; 50mg, oral administration 3 times per day
Intervention MeSH terms: Trazodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Efficacy, and Tolerability Study of PF-06480605 in Subjects With Moderate to Severe Ulcerative Colitis.
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and efficacy of
      PF-06480605 in subjects with moderate to severe ulcerative colitis.
    

Detailed description: 
      This is a Phase 2a, single arm, two-stage study in subjects with moderate to severe
      ulcerative colitis. Subjects will receive 500 mg of PF-06480605 intravenously every 2 weeks
      for a total of 7 doses. Blood, stool, and tissue samples will be collected at various time
      points throughout the study to evaluate safety, tolerability, efficacy, pharmacokinetics, and
      immunogenicity. Duration of participation for subjects will be approximately 8 months.
    

Intervention name(s): PF-06480605
Intervention type(s): Drug
Intervention description(s): PF-06480605 500 mg IV Q2W x 7 Doses
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Analgesic Effect of Ketamine Vs Ketamine Magnesium Infusion and Their Effect on Postoperative Morphine Consumption
Condition: Nephrectomy
Study type: Interventional
Phase: Phase 1

Summary: 
      Ketamine and magnesium-ketamine are two analgesics that are being studied for use as
      adjuvants. They were shown to have anaesthetic and analgesic properties, and as a consequence
      of this finding, it has been postulated that they may have a role in minimising the
      requirement for analgesic drugs during the postoperative period. The major objective of the
      research was to examine the pain-relieving effects of ketamine vs ketamine magnesium
      infusion, as well as their influence on postoperative morphine consumption following
      nephrectomy; the secondary goal is to assess hemodynamic effects and pain severity.
    

Detailed description: 
      Renal necrosis factor (RN) therapy, which includes ipsilateral adrenalectomy, was first
      utilized to treat renal cortical tumours in 1969. A radical nephrectomy is a surgical surgery
      in which the whole kidney, as well as the surrounding fat and, in some cases, the adrenal
      gland and lymph nodes, are removed. This operation is carried out as an inpatient .

      Opioid use, on the other hand, can result in considerable side effects and adverse events,
      which can result in much longer hospital stays and higher postsurgical hospital costs.
      Although opioid-based analgesia is essential for postoperative pain management, opioid usage
      may have serious adverse effects .

      Finding techniques to limit opioid intake in the postoperative period is essential because
      cases that got increased opioid dosages are more likely to have the negative effects. Using
      non-opioid analgesics alongside opioid analgesics, known as analgesia of multi-modes, to
      enhance post-operative pain management while reducing the usage of the opioids. .

      Ketamine, also and magnesium-ketamine are two analgesics wich are non-opioid that are being
      studied for use like opioid analgesic adjuvants. They were discovered to have anaesthetic and
      analgesic properties, and it has been proposed that as a result of this discovery, they may
      have a great contribution in reducing the need for postoperative analgesic medications .
    

Intervention name(s): Ketamine
Intervention type(s): Drug
Intervention description(s): to examine the pain-relieving effects of ketamine vs ketamine magnesium infusion, as well as their influence on postoperative morphine consumption following nephrectomy; the secondary goal is to assess hemodynamic effects and pain severity
Other intervention name(s): Ketamine Magnesium; Morphine
Intervention MeSH terms: Ketamine; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Ketamine; Ketamine Magnesium,; Analgesic,; morphine consumption,; Nephrectomy
Moderate-Intensity Exercise Versus High-Intensity Interval Training to Recover Walking Post-Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The objective of this study is to determine the optimal training intensity and the minimum
      training duration needed to maximize immediate improvements in walking capacity in chronic
      stroke. A single-blind, phase II, 3-site randomized controlled trial has been planned. Fifty
      persons >6 months post stroke will randomize to either moderate-intensity aerobic locomotor
      training or high-intensity interval locomotor training; each for 45 minutes, 3x/week for up
      to 36 total sessions over approximately 12 weeks. Clinical measures of walking function,
      aerobic fitness, daily walking activity and quality of life will be assessed at baseline
      (PRE) and after 4, 8 and 12 weeks of training (POST-4WK, POST-8WK, POST-12WK).
    


Intervention name(s): Moderate-Intensity Aerobic Training; High-Intensity Interval Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Overground and treadmill walking with speed continuously adjusted to maintain a target heart rate of 40 +/- 5% heart rate reserve, progressing up to 55 +/- 5% heart rate reserve.; Overground and treadmill walking with 30 second bursts at maximum speed alternated with 30-60 second passive recovery periods. Intended to achieve a target average heart rate above 60% heart rate reserve.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rehabilitation; Locomotion; Aerobic; Intensity; Dosing
Pharmacokinetics and Tolerability of Meloxicam Gel Compared to Meloxicam Tablets in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to gain information on the percutaneous absorption of meloxicam after administration of
      a topical gel over 7 days.
    


Intervention name(s): Meloxicam gel; Meloxicam tablet
Intervention type(s): Drug; Drug
Intervention MeSH terms: Meloxicam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Bi-level ESPB Application in Patients Undergoing VATS
Condition: Pain, Postoperative; Thoracic Surgery, Video-Assisted; Erector Spinae Plane Block; Multimodal Analgesia
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery.
      Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods
      such as thoracic paravertebral block (TPVB), intercostal block and erector spina plane block
      (ESPB) are widely used for VATS. Among these methods, ultrasound (US) guided TPVB is the most
      preferred method. In recent years, the frequency of application of plane blocks as a
      component of multimodal analgesia has been increased. ESPB is one of them. Although there are
      publications showing that single-level ESPB applied from the T5 vertebra level spreads in the
      craniocaudal T3-L2 range, there are also publications stating that the spread is more
      limited. This study, it was aimed to compare the efficacy of bi-level ESPB application and
      one-level ESPB application for postoperative analgesia in patients undergoing VATS.
    


Intervention name(s): One-level Erector Spinae Plane Block; Bi-level Erector Spinae Plane Block
Intervention type(s): Procedure; Procedure
Intervention description(s): One-level Erector Spinae Plane Block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, and when the patient is placed in the lateral decubitus position. In applications, 30 ml of 0.25% bupivacaine will be injected at the T5 level.; Bi-level Erector Spinae Plane Block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, and when the patient is placed in the lateral decubitus position. In applications, 15 ml of 0.25% bupivacaine at T4 level and 15 ml of 0.25% bupivacaine at T6 level will be injected.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Awareness of COVID-19 in Turkey
Condition: Healthy
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Because COVID-19 is a new virus, it is believed that awareness assessment will inform and
      guide what steps should be taken and which groups should be targeted in terms of controlling
      the pandemic. According to our hypothesis, COVID-19 awareness of individuals in different age
      groups in the Turkish population also varies. There are controlling pratices based on
      scientific studies made during the outbreak, but there is no certainty as to how much these
      measures are known by our society. Based on these, the aim of our study was to investigate
      and compare the awareness of new Coronavirus (COVID-19) in different age groups across
      Turkey.
    

Detailed description: 
      Statistical Analysis: In the statistical analysis of the data obtained at the end of the
      study, SPSS (Statistical Package for Social Sciences / SPSS 21.0) was analyzed using the
      statistical program. In the study, arithmetic averages are presented with tables and graphs
      as mean ± SD (standard deviation) and values indicated by counting in numbers (percent).
      Demographic information of the participants and their responses to the questionnaire
      questions were evaluated using descriptive statistical analysis method. In the study,
      Independent Sample t Test was used in parametric data and ANOVA was used in normal
      non-parametric data. In all analyzes, p <0,05 was considered statistically significant.

      Sampling: Sample size was calculated based on the number of questions asked. Accordingly, the
      number of questions multiplied by the formula of 60 is the lower limit (42*60=2520).
      Considering the 20% probability of a drop-out and the fact that participants did not want to
      volunteer, it was decided to take 3150 people to the study. Consent will be obtained from the
      participants through a voluntary information form.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        people of diffirent age groups throughout Turkey
      
Keywords: COVID-19; Pandemic; Knowledge and Awareness; Adolescent; Adults
Magnesium Loading in Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Dietary magnesium (Mg) intake has been shown to be independently related to lung function,
      airway reactivity, and respiratory symptoms in the general population. Inhaled Mg and IV Mg
      administration have been shown to promote bronchodilation and to improve lung function in
      asthmatic patients. Some studies have suggested that COPD patients exhibit decreased body
      levels of Mg. The purpose of the present study was to investigate the effects of acute IV Mg
      loading on parameters of respiratory function and maximal exercise capacity of stable COPD
      patients.The study hypothesis is that Mg administration will be associated to improvements on
      airflow and vasodilation leading to improvements of pulmonary function and exercise
      performance.
    

Detailed description: 
      Patients are required to have a diagnosis of COPD according to the Global Initiative for
      Chronic Obstructive Lung Disease criteria.

      This is a randomized, double-blind, placebo-controlled, cross-over study. Twenty five
      patients are going to be included. They are going to come to the laboratory to receive IV
      placebo or IV Mg sulfate at two distinct occasions about 48 hours apart. Half of the patients
      are going to receive Mg first and Placebo at the second day, while the other half are going
      to receive the treatments in an inverse order. Tests are going to be performed before and
      about 40 minutes after the IV infusions. Tests to be performed are: spirometry, arterial
      blood gases, Mg plasma level measurements, and a maximal exercise test protocol in
      cycloergometer.
    

Intervention name(s): Magnesium Sulfate 2 grams
Intervention type(s): Drug
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: COPD; Magnesium; Pulmonary function; Exercise Physiology
Bandage Lenses in Treating Patients With Ocular Graft-Versus-Host Disease
Condition: Graft Versus Host Disease; Ophthalmologic Complications
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II clinical trial studies how well bandage lenses work in treating patients with
      ocular graft versus host disease. Bandage lenses may be helpful in relieving eye symptoms and
      damage caused by eye graft versus host disease.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine the symptom improvement after 2 weeks of therapy with bandage lenses.

      SECONDARY OBJECTIVES:

      I. To confirm short-term safety within 1 month after bandage lenses.

      II. To determine improvement in ophthalmologic examinations after bandage lenses.

      III. To explore the use of optical coherence tomography as an objective measure of corneal
      inflammation.

      OUTLINE:

      Patients wear bandage lenses continuously for at least 3 months in the absence of disease
      progression or unacceptable toxicity.
    

Intervention name(s): graft versus host disease prophylaxis/therapy; questionnaire administration; optical coherence tomography
Intervention type(s): Biological; Other; Procedure
Intervention description(s): Wear bandage lenses; Ancillary studies; Optional ancillary studies
Other intervention name(s): prophylaxis/therapy, graft versus host disease; prophylaxis/therapy, GVHD
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Chronic graft-versus-host disease; eye
A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate sleep onset following administration of Transcept
      zolpidem tartrate sublingual tablet versus placebo in adult insomnia patients.
    


Intervention name(s): zolpidem tartrate sublingual tablet 3.5mg; zolpidem tartrate sublingual tablet 1.75mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.; Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.; Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
Other intervention name(s): Intermezzo®; Intermezzo®
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Insomnia
Diabetes Go Mobile! Pilot Study
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether a behavioral lifestyle intervention using
      mobile smart phone technology for self-monitoring can lead to greater improvements in
      diabetes outcomes.
    

Detailed description: 
      The investigators will conduct a pilot randomized controlled clinical trial to examine the
      feasibility and preliminary efficacy of a behavioral lifestyle intervention on weight,
      glycemic control, and vascular inflammatory marker outcomes. A total of 26 overweight or
      obese patients with type 2 diabetes will be recruited from an underserved minority community
      health center in Houston, TX. They were randomly assigned into one of the three groups: 1)
      Behavior intervention with smart phone based self-monitoring, 2) Behavior intervention with
      paper diary based self-monitoring, and 3) Usual care group. Both Mobile and Paper groups
      received a total of 11 group sessions and 1 individual session in a 6-month intervention.
      Mobile group received an android-based smart phone with two applications loaded to help them
      record their diet, physical activity, weight, and blood glucose, while the paper group is
      using paper diaries for these recordings.
    

Intervention name(s): Behavior intervention with smart phone based self-monitoring; Behavior intervention with paper diary based self-monitoring
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Use two smartphone applications for self-monitoring of diet, physical activity, weight, and blood glucose (connected via a blue-tooth enabled glucometer), plus 11 group session and 1 individual session focused on behavioral strategies; Use paper diaries along with a calorie counter booklet, weight scale, food scale, and pedometer for self-monitoring of diet, physical activity, weight, and blood glucose, plus 11 group session and 1 individual session focused on behavioral strategies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Observational Study to Evaluate Vandetanib in RET -/+ Patients With Metastatic Medullary Thyroid Cancer
Condition: Symptomatic, Aggressive, Sporadic, Unresectable, Locally; Advanced/Metastatic Medullary Thyroid Cancer (MTC)
MeSH terms: Thyroid Neoplasms; Carcinoma, Neuroendocrine; Thyroid Diseases; Aggression
Study type: Observational

Summary: 
      This is a European multinational, multicenter, non-interventional (observational) and
      prospective study. It is carried on to confirm in real life conditions the benefit/risk of
      vandetanib (CAPRELSA™) 300 mg, both in RET negative and RET positive patients with
      symptomatic, aggressive, sporadic, unresectable, locally advanced/metastatic MTC.
    

Detailed description: 
      This is a multinational, multicenter, non-interventional (observational) and prospective
      study. European countries where vandetanib is on the market will participate in the study.

      This study is being conducted to fulfil the specific obligation post-authorisation measure
      for the conditional marketing authorisation. It is carried on to confirm in real life
      conditions the benefit/risk of vandetanib (CAPRELSA™) 300 mg, both in RET negative and RET
      positive patients with symptomatic, aggressive, sporadic, unresectable, locally
      advanced/metastatic MTC. The clinical benefit of vandetanib (CAPRELSA™) 300 mg has previously
      been established in a clinical trial (Study 58) on the basis of a clinically and
      statistically significant advantage in progression free survival (PFS) which was supported by
      a high response rate and substantial duration of response.
    

Intervention name(s): Vandetanib 300 mg
Intervention type(s): Drug
Intervention description(s): Vandetanib commercial tablets
Other intervention name(s): ZD6474, CAPRELSA
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Symptomatic, Aggressive, Sporadic, Unresectable, Locally Advanced/Metastatic
        Medullary Thyroid Cancer (MTC)
      
Keywords: RET Mutation; DIagnostics; Medullary Thyroid Cancer; MTC
Effect of a Specific Blend of Fibers and Probiotics on the Microbiome
Condition: Microbiota Perturbation by an Environmental Challenge
Study type: Interventional

Summary: 
      The study will investigate the effect of a mix of fibers and probiotics on faecal microbiota
      challenged by an environmental stress
    


Intervention name(s): Fibers and probiotics
Intervention type(s): Dietary Supplement
Intervention description(s): A blend of fibers and seven probiotics
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention