bioihbjkbjnl/mcl2 huggingface dataset:
A Safety and Efficacy Study to Evaluate AMG 334 in Migraine Prevention
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomized, double-blind, placebo-controlled, parallel-group, multicenter study followed by
      an open-label treatment phase (OLTP). To evaluate the effect of erenumab (AMG 334) compared
      to placebo on the change from baseline in monthly migraine days.
    

Detailed description: 
      This is a Phase 2, randomized, double-blind, placebo-controlled study in participants with
      episodic migraine. The study's double blind treatment phase (DBTP) is designed to evaluate if
      treatment with erenumab once a month for 6 months compared with placebo is effective in
      reducing the mean monthly migraine days. Additionally, this study will continue to evaluate
      the efficacy and safety of erenumab during the OLTP where participants will continue to
      receive active treatment monthly.

      The study also includes a clinical home use (CHU) sub-study to assess a participant's ability
      to self-administer 140 mg of erenumab. Participants will be randomized 1:1 to use either 2
      pre-filled 70 mg/mL autoinjector (AI)/pens or 1 pre-filled 140 mg/mL AI/pen. Participation in
      the substudy is optional, and no additional samples will be collected for the sub-study.

      After implementation of Protocol Amendment 2, the dose of erenumab in the OLTP increased from
      70 mg to 140 mg QM. Participants who had already completed week 48 remain on 70 mg QM,
      participants not yet starting the OLTP, or not yet completing the week 48 visit receive
      erenumab 140 mg QM for the remainder of the OLTP.
    

Intervention name(s): Placebo; Erenumab; Erenumab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): placebo via subcutaneous injection; erenumab via subcutaneous injection; erenumab via autoinjector (AI)/pen
Other intervention name(s): AMG 334, Aimovig™; AMG 334, Aimovig™
Intervention MeSH terms: Erenumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Migraine Prevention; Headache; Prophylaxis
Lidocaine Irrigation in Shoulder Arthroscopy
Condition: Postoperative Pain; Analgesia
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Arthroscopic shoulder surgery is often associated with severe postoperative pain that is
      often significant enough to interfere with initial recovery and rehabilitation. The pain that
      can be difficult to manage without large dose of opioid.

      The study aim to explore the effect of continuous irrigation of fluids mixed with lidocaine
      and epinephrine for analgesic consumption and postoperative pain after shoulder arthroscopy.
    


Intervention name(s): Lidocaine epinephrine; Epinephrin
Intervention type(s): Drug; Drug
Intervention description(s): Under aseptic condition every one litre of fluid irrigation will be mixture with 10 ml of lidocaine 2% and 0.25mg epinephrine and the last one use before end of surgery dexamethasone 8 mg will be added.; 0.25 mg epinephrine mixed with one litre of fluid irrigation
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Postoperative pain; Lidocaine; Shoulder arthroscopy
Pharmacokinetic Characterization of Two Novel CG5503 Tablet Formulations in Healthy Volunteers
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study investigated the pharmacokinetics (how a drug is taken up and excreted from the
      body), safety, and tolerability of 2 new tapentadol (CG5503) tablet formulations compared to
      a previously characterized tapentadol prolonged-release (PR) tablet formulation.
    

Detailed description: 
      The study was performed to evaluate the pharmacokinetic characteristics (relative
      bioavailability) of 2 new tapentadol (CG5503) tablet formulations (Test Product 1 and Test
      Product 2) containing 116 mg tapentadol hydrochloride each, as compared to a 116-mg
      tapentadol hydrochloride PR tablet (Reference Product) and to explore the effect of food on
      the bioavailability of the 2 new tapentadol formulations. Participants received a single dose
      of each of the test formulations under fasting or fed conditions and of the reference
      formulation under fasting conditions in a randomized order. There was a wash-out period of at
      least 3 days between consecutive treatments. Blood samples were taken from pre-dose up to 32
      hours post-dose for pharmacokinetic analyses.

      Furthermore, the study compared the safety and tolerability of the test formulations with
      that of the reference. Adverse events and vital signs were documented at screening, pre-dose,
      and up to 32 hours post-dose. Clinical laboratory parameters were determined and 12-lead
      electrocardiograms (ECG) were recorded at screening and at discharge. A final medical
      examination was performed at 2-14 days after discharge following the last treatment.
    

Intervention name(s): Tapentadol Test Product 1; Tapentadol Test Product 2; Tapentadol Prolonged-release Reference Product
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tapentadol tablet containing 116 mg of tapentadol hydrochloride; Tapentadol Test Product 1 contains different amounts of excipients than Tapentadol Test Product 2; Tapentadol tablet containing 116 mg of tapentadol hydrochloride; Tapentadol Test Product 2 contains different amounts of excipients than Tapentadol Test Product 1; Tapentadol PR tablet containing 116 mg of tapentadol hydrochloride
Intervention MeSH terms: Tapentadol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomization was performed according to Williams' design, with 5 periods and 10 sequences. There was a washout of at least 3 days between the consecutive administrations.
Masking: None (Open Label)
Primary purpose: Treatment
A Single-Dose Trial to Examine the Within Subject Variability of Clexane® in Healthy Adults Under Fasting Conditions
Condition: Clexane is Administered to Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary: To examine the within subject variability of Clexane (80 mg) in healthy male and
      female volunteers administered subcutaneously (s.c.) as a single dose, in two periods, under
      fasting conditions.

      Secondary: To monitor safety during the Treatment Periods.
    

Detailed description: 
      This was a pilot, open-label study to evaluate the PK of enoxaparin following s.c.
      administrations of 80 mg Clexane, on 2 different occasions, in 14 healthy adult subjects.

      The study comprised a Screening Visit and 2 Treatment Periods (1 and 2). Screening (Day -14
      to Day -1): Screening assessments were carried out within 14 days before administration of
      the first dose of Clexane. Eligible subjects were asked to return for Treatment Period 1.

      Treatment Periods 1 and 2 (Day 0 to Day 26): Eligible subjects received two doses of s.c.
      Clexane over 2 Treatment Periods (1 dose/period). Final confirmation of eligibility was made
      prior to dosing during Treatment Period 1. Confirmation of ongoing eligibility was made prior
      to dosing during Treatment Period 2.

      Each Treatment Period was of 2 days duration, from the afternoon before dosing (Day 0) until
      36 hours (h) post-dose (evening of Day 2). During each Treatment Period, subjects resided at
      the Clinical Unit. Study drug was administered on the morning of Day 1 following an overnight
      fast. Pharmacokinetic (PK) samples were collected pre-dose and up to 36 h post-dose (x14
      samples) for the measurement of enoxaparin. Safety was also evaluated at specified times
      throughout the study. There were at least 7 days between each dose administration. The
      Post-Study Follow-Up was conducted on Day 2 of Treatment Period 2 after completion of the 36
      h PK blood sampling and vital sign check.
    

Intervention name(s): Enoxaparin sodium
Intervention type(s): Biological
Intervention description(s): comparison of 2 different administration of drug
Other intervention name(s): Clexane
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: enoxaparin sodium
Manicaland VMMC Uptake Through Behavioural Incentives Trial
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      Primary Objective The purpose of this study is to evaluate the impact of an interactive VMMC
      education session offered by a circumcised health worker and contribution to transport costs
      for accessing VMMC along with either (1) conditional economic compensation for wages or (2)
      lottery-based economic incentives on the uptake of VMMC.

      Hypothesis VMMC education session offered by a role model - a young male health worker who
      has been previously benefited from VMMC services in this community - addressing risks of HIV
      infection, benefits of VMMC, and the fear of pain associated with VMMC, with/without a
      conditional fixed or lottery-based financial incentives off-setting present-biased
      preferences, will improve risk perception and increase uptake of VMMC in HIV-negative young
      men.

      Study outcomes The primary outcomes for the study will be risk perception measured in a
      follow-up survey at 6 months and proportion of men taking up VMMC within 6 months measured
      through self-reports and matched to program records.
    


Intervention name(s): Education session with fixed incentive; Education session with lottery incentive
Intervention type(s): Behavioral; Behavioral
Intervention description(s): All participants will receive an education session on the risk of HIV infection and benefits from medical male circumcision. The sessions will be implemented by trained male healthcare workers who have undergone VMMC.
All participants will receive contributions towards transport costs to access medical male circumcision at participating clinics. On completing VMMC, participants assigned to receive fixed incentives will receive payment through mobile payments. In two sites a community-led intervention will also be implemented to address social obstacles and to increase support from peers, families and social structures.; All participants will receive an education session on the risk of HIV infection and benefits from medical male circumcision. The sessions will be implemented by trained male healthcare workers who have undergone VMMC.
All participants will receive contributions towards transport costs to access medical male circumcision at participating clinics. On completing VMMC, participants will participate in a lottery with prizes equivalent in expected value to the fixed incentives. In two sites a community-led intervention will also be implemented to address social obstacles and to increase support from peers, families and social structures.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Voluntary medical male circumcision; HIV prevention; Risk perception
Effects of Cocoa on Gastrointestinal Function
Condition: Gastrointestinal and Digestive Disorder
MeSH terms: Digestive System Diseases
Study type: Interventional

Summary: 
      This is a randomized, controlled, 2x2 cross-over study to assess the effects of cocoa solids
      on gastrointestinal transit, post-prandial sensation and well-being. Additionally functional
      brain imaging will be applied to identify regions of brain that are activated or inactivated
      by cocoa ingestion. Healthy subjects will be recruited and randomized to receive either dark
      chocolate (70% cocoa solids) or white chocolate (0% cocoa solids) in addition to their normal
      diet in randomized order. Reference standard methodology will be applied to measure gastric
      emptying, oro-caecal and colonic transit time. Dark and white chocolate (100g, ~500kcal, ~50%
      fat) will be consumed with radio-opaque markers on three consecutive days. On the third day
      chocolate ingestion will be followed by measurements of postprandial brain activity using
      FDG-Positron Emission Tomography. Additionally colonic transit will be assessed based on the
      number and distribution of radio-opaque markers in the colon. On the fourth day gastric
      emptying and oro-caecal transit time will be assessed by scintigraphy after ingestion of a
      dark or white chocolate mousse test meal (both 150g, ~500kcal, ~50% fat). During both
      interventional studies pre- and post-prandial satiety and dyspeptic symptoms, well-being and
      mood will be recorded. Additionally, validated questionnaires will assess digestive comfort
      and well-bring at the end of each study day. These results will deliver comprehensive
      information about the effects of cocoa on gastrointestinal transit and sensation.
    


Intervention name(s): Dark chocolate bar; Dark chocolate mousse; White chocolate bar; White chocolate mousse
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Dark chocolate bar (70% cocoa solids (~500kcal, ~50% fat)), 100g / day for 3 days to assess postprandial brain activity and colonic transit by FDG-PET.; Dark chocolate mousse (150g, ~500kcal, ~50% fat) to assess gastric emptying and oro-caecal transit time by scintigraphy.; White chocolate bar (0% cocoa solids (~500kcal, 50% fat)), 100g / day for 3 days to assess postprandial brain activity and colonic transit by FDG-PET.; White chocolate mousse (150g, ~500kcal, ~50% fat) to assess gastric emptying and oro-caecal transit time by scintigraphy.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy of Neuro+ Attention Training
Condition: ADHD
Study type: Interventional

Summary: 
      This study evaluates the efficacy of the Neuro+ Attention Training System (Neuro+) in
      improving attention skills in children. Half of participants will receive the Neuro+
      intervention for 10 weeks, while the other half will continue treatment as usual (TAU) for
      the same period. We expect those receiving the Neuro+ intervention to see significant
      improvements in ADHD symptoms relative to the TAU controls.
    

Detailed description: 
      Neuro+ a non-pharmacological intervention that targets the underlying neural signatures and
      cognitive deficits which are assumed to mediate attention pathways. Targeting those
      underlying areas could reduce ADHD symptoms and potentially lead to greater transfer and
      generalization to functioning in the classroom and every day life.

      Neuro+ combines neurofeedback, biofeedback, and go/no-go training protocols embedded in a
      training video game to help develop and improve attention skills. The protocols function as
      follows:

      Neurofeedback: Users wear a dry, wireless, easy-to-use EEG headset that interfaces with
      computer software to provide feedback on their level of brain activation, or focus. Users
      must focus in order to advance through the training game.

      Motion-biofeedback: Accelerometers in the headset send data on users' movement to the
      training game, such that users must maintain complete control of their bodies and remain
      absolutely still in order to advance through the game and avoid costly point penalties.

      Go/no-go training: To practice impulse control, users will be challenged with adaptive
      "go/no-go tasks," requiring them to quickly and accurately respond to target stimuli and
      ignore distractions, with the tasks becoming more difficult as the user improves.
    

Intervention name(s): Neuro+ Attention Training; Treatment as Usual
Intervention type(s): Behavioral; Other
Intervention description(s): Attention training program with Neuro+ software; Continuation of current ADHD treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Neurofeedback; Biofeedback; Neuro+; Go/no-go; Attention training
CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF)
Condition: Persistent Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      This is a multi-center, open label, randomized pivotal study evaluating the safety and
      efficacy of the EPi-Sense-AF Guided Coagulation System for the treatment of persistent AF
      patients, refractory or intolerant to at least one Class I and/or III Anti Arrhythmic Drug
      (AAD).
    

Detailed description: 
      The objective of this randomized pivotal study is to evaluate the safety and efficacy of the
      AtriCure EPi-Sense®-AF Guided Coagulation System with VisiTrax® for the treatment of
      symptomatic persistent Atrial Fibrillation (AF) patients, refractory or intolerant to at
      least one Class I or Class III anti-arrhythmic drug (AAD). 153 subjects from up to 27 US and
      3 OUS sites. Randomized 2:1.

      The primary efficacy endpoint is success or failure to be AF/AT/AFL free absent class I and
      III AADs except for a previously failed or intolerant class I or III AAD with no increase in
      dosage following the 3-month blanking period through the 12-month post procedure follow-up
      visit.

      The primary safety endpoint is the incidence of major adverse events (MAEs) listed in the
      protocol for subjects undergoing the convergent procedure for the procedural to 30-day post
      procedure time period.
    

Intervention name(s): AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax; Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering
Intervention type(s): Device; Device
Intervention description(s): Convergent Epicardial Endocardial Ablation Procedure; Endocardial Catheter Ablation Procedure
Other intervention name(s): Epicardial EPi-Sense-AF Guided Coagulation System combined with endocardial RF catheter ablation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2:1 randomized (Convergent Procedure versus standalone endocardial catheter ablation) multi-center pivotal clinical study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial Fibrillation; Convergent Procedure; Combined Epicardial/ Endocardial Ablation; Hybrid Procedure; Radiofrequency Ablation; Arrhythmia; RF Ablation
Impact of Increasing Levothyroxine Dose in Ramadan for UAE Patients With Hypothyroidism
Condition: L-thyroxine
MeSH terms: Hypothyroidism
Study type: Interventional
Phase: Phase 4

Summary: 
      The study aims to compare the mean change in Thyroid Stimulating Hormone (TSH) levels among
      patients with hypothyroidism treated with an increased dose of L-thyroxine (treatment group)
      versus standard/regular dose of L-thyroxine (control group) during the month of Ramadan.
    

Detailed description: 
      The present study is an open-label, two-arm parallel groups, randomized controlled clinical
      trial that included Emirati patients with hypothyroidism who attended the Family Promotion
      Centre, Endocrinology Clinic, regularly. Eligible participants (n = 103) were randomly
      allocated to the treatment group (patients who received an increased dose of L-thyroxine, 25
      mcg, n = 50) and the control group (patients who received standard/regular dose of
      L-thyroxine, n = 46). Both groups attended 5 visits before, during, and after Ramadan.
      Several tests were conducted including thyroid function, lipid profile, HbA1c, and Vitamin D.
    

Intervention name(s): Extra dose of L-thyroxine, 25 mcg during Ramadan
Intervention type(s): Drug
Intervention description(s): Extra dose of L-thyroxine, 25 mcg during the month of Ramadan
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The present study is an open-label, two-arm parallel groups, randomized controlled clinical trial that included Emirati patients with hypothyroidism who attended the Family Promotion Centre, Endocrinology Clinic, regularly. Eligible participants (n = 103) were randomly allocated to the treatment group (patients who received an increased dose of L-thyroxine, 25 mcg, n = 50) and the control group (patients who received standard/regular dose of L-thyroxine, n = 46). Both groups attended 5 visits before, during, and after Ramadan. Several tests were conducted including thyroid function, lipid profile, HbA1c, and Vitamin D.
Masking: None (Open Label)
Primary purpose: Treatment
Prevalence and Risk Factors in Unipolar Depression Patients Without Remission After One Antidepressant Trial
Condition: Non-psychotic Unipolar Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Observational [Patient Registry]

Summary: 
      A non interventional, descriptive, longitudinal cohort study is designed, trying to obtain
      local data about the prevalence of non remitted depressed patients after an antidepressant
      treatment, and to get information about sociodemographic and clinical characteristics of
      these patients as well as features of their treatments and compare them with those of the
      patients that achieve remission. Also the effect of patient´s expectation in the treatment
      outcome will be examined.
    

Detailed description: 
      A non interventional, descriptive, longitudinal cohort study is designed, trying to obtain
      local data about the prevalence of non remitted depressed patients after an antidepressant
      treatment, and to get information about sociodemographic and clinical characteristics of
      these patients as well as features of their treatments and compare them with those of the
      patients that achieve remission. Also the effect of patient´s expectation in the treatment
      outcome will be examined.

      Non psychotic depressed patients that are initiating an antidepressant treatment will be
      recruited. Socio demographic and clinical features will be recorded as well as their
      expectations before the treatment. Severity of depression and treatment characteristics will
      be recorded after 4 to 8 weeks of drug treatment at an adequate dose. Variables will be
      compared between the patients that will achieve remission and those that do not.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals between 18 and 75 years old that have non-psychotic unipolar major depression
        and have not been treated for the current episode.
      
Keywords: Non-psychotic unipolar major depression; Resistant depression