bioihbjkbjnl/mcl2 huggingface dataset:
Total Neoadjuvant Induction and Consolidation CapeOX Plus IMRT With Capecitabine for MRI Defined High-risk Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to test the efficacy and safety of total neoadjuvant induction and
      consolidation CapeOX plus neoadjuvant intensity modulated radiotherapy with concurrent
      capecitabine for MRI defined high-risk rectal cancer.
    

Detailed description: 
      This phase II trial is studying the efficacy and safety of total neoadjuvant treatment for
      MRI defined high-risk locally advanced rectal cancer.

      MRI imaging features as mrT3c/T3d/T4a/T4b, threatening circumferential resection margin, mrN2
      disease or extramural vascular invasion are defined as high-risk factor and proved to
      associated with unfavorable oncological outcome, especially for distant metastasis. Induction
      and consolidation chemotherapy plus radiation may increase both systemic and local control.
      Total neoadjuvant treatment schedule also has advantages as improved patient tolerance, early
      closure of defunctioning ileostomy etc.

      In this study, patients with MRI defined high-risk rectal cancer will receive 3 cycles
      induction CapeOX, intensity modulated radiotherapy with concurrent capecitabine and 2 cycles
      consolidation CapeOX and Total mesorectal excision.

      The induction chemotherapy related G3-4 toxicity occurred in 42% of patients in GCR-3 trial
      (23% during RT, 19% during induction chemotherapy). It is hypothesized that the neoadjuvant
      chemotherapy related G3-4 toxicity rate of the present regimen will be lower than 25% (10%
      during IMRT, 15% during induction/consolidation chemotherapy). A sample size of 67 achieves
      80% power to detect a difference (△P =17%, P1=25%, P0=42%) using a one-sided binomial test.
      (α= 0.05). If the number of G3-4 toxic event is 21 or less, the hypothesis that P1>= 42% is
      rejected. About 10 % loss to follow-up was anticipated, so an additional eight patients will
      be recruited. The study requires 75 subjects in all.
    

Intervention name(s): Oxaliplatin; Capecitabine; Intensity modulated radiotherapy; Total mesorectal excision
Intervention type(s): Drug; Drug; Radiation; Procedure
Other intervention name(s): OXA; CAPE; IMRT; TME
Intervention MeSH terms: Capecitabine; Oxaliplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rectal cancer; neoadjuvant; radiotherapy; chemotherapy; toxicity
Trial of Sirolimus for Cognitive Impairment in Sturge-Weber Syndrome
Condition: Sturge-Weber Syndrome
MeSH terms: Sturge-Weber Syndrome; Brain Stem Infarctions; Klippel-Trenaunay-Weber Syndrome; Syndrome; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this research study is to gain a preliminary understanding of the safety of
      sirolimus in Sturge-Weber syndrome (SWS) and determine best outcomes to be used to assess the
      utility of sirolimus for the treatment of cognitive impairments related to Sturge-Weber
      syndrome.
    

Detailed description: 
      Sirolimus will be administered as an adjunct to all current medications. The impact of
      sirolimus upon cognitive functioning in Sturge-Weber syndrome is the primary outcome measure.
      This outcome will be assessed using a panel of testing selected based upon extensive
      experience in testing cognitive function in adults and children with SWS at the Kennedy
      Krieger Sturge-Weber Center. Changes in a quantitative EEG before and after the trial,
      Sturge-Weber syndrome clinical neuroscore, port-wine birthmark score, and the impact of
      sirolimus upon seizures will be assessed.
    

Intervention name(s): Sirolimus
Intervention type(s): Drug
Intervention description(s): Low dose oral sirolimus
Other intervention name(s): Rapamycin; Rapamune
Intervention MeSH terms: Sirolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SWS; Cognitive impairment; sirolimus
Metabolic Consequences of Heterozygous Hereditary Fructose Intolerance
Condition: Hereditary Fructose Intolerance; Fructose Metabolism, Inborn Errors; Glucose Metabolism Disorders
MeSH terms: Metabolism, Inborn Errors; Fructose Intolerance; Fructose Metabolism, Inborn Errors; Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      Background: High fructose intake increases blood lactate, triglyceride and uric acid
      concentrations. Uric acid may contribute to insulin resistance and dyslipidemia in the
      general population. In patients with hereditary fructose intolerance fructose consumption is
      associated with acute hypoglycemia, renal tubular acidosis, and hyperuricemia.

      Objective: We investigated whether asymptomatic carriers for hereditary fructose intolerance
      (HFI) would have a higher sensitivity to adverse effects of fructose than the general
      population.

      Design: Eight subjects heterozygous for HFI (hHFI; 4 males, 4 females) and eight controls
      received for 7 days a low fructose diet and on the eighth day ingested a test meal calculated
      to provide 25% of basal energy requirement containing labeled fructose (13C fructose 0.35
      g/kg), protein (0.21 g/kg) and lipid (0.22 g/kg). Total fructose oxidation, total endogenous
      glucose production (by 6,6-2H2-glucose dilution), carbohydrate and lipid oxidation, lipids,
      uric acid, lactate, creatinine, urea and amino acids were monitored for 6 hours.
    


Intervention name(s): Test meal
Intervention type(s): Other
Intervention description(s): Assessment of postprandial responses to a mixed meal containing fructose in carriers of one mutated ALDOB allele.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Cervical Kinematics' Reliability: Zero Positioning Using a 3-D-bulls Eye Spirit Level
Condition: Kinematics; Reliability; Cervical
Study type: Interventional

Summary: 
      The measurement of cervical spine range of motion (ROM) figures among the most common aspects
      of clinical diagnosis. Good reliability has been demonstrated for assessments using
      ultrasonic movement analysis systems, such as Zebris CMS 70 (Isny, Germany). However, in
      contrast to combined measurements of movement amplitudes (e.g., flexion plus extension in the
      sagittal plane), separating the respective components provides less reliable results. Current
      research suggest that this is due to the participants' determination of the zero position.
      This position is influenced by possible disposed treatments and, in particular, by the
      subject in case of subjective determination. The present study therefore aims to examine the
      test-retest reliability of separate ROM assessments using a bulls eye spirit meter.

      Twenty healthy participants will be included in the trial that adopts a two-armed randomized,
      crossover design. With a washout-period of one week in between, each subject participates in
      two sessions in a randomised order. In both sessions, cervical ROM (flexion/extension,
      rotation, lateral flexion) will be measured twice (with a five-minute wait period). In all
      measurements, the zero position will be determined by means of a bulls eye spirit level. The
      difference of the two sessions consists in the design of the waiting period. In one session,
      the subjects will keep the mask carrying the ultrasound markers on their head. In the other
      session, the mask will be removed during the break.
    


Intervention name(s): Zebris CMS 70; 3-D Bulls Eye Spirit Meter
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Turkish Validity and Reliability of the UW Concerns About Pain Scale
Condition: Chronic Low-back Pain
MeSH terms: Low Back Pain
Study type: Observational

Summary: 
      Brief Summary:

      The aim of this study was to determine the Turkish validity and reliability of ''UW Concerns
      About Pain Scale'' developed by Dr. Amtmann.
    

Detailed description: 
      Chronic pain is a common condition, affecting an estimated 20% of people worldwide. The
      biopsychosocial model of chronic pain is the most current accepted approach to understanding
      the complexity of pain and disability. One of the most important psychosocial factors in this
      approach is pain-related self-efficacy, which is defined as the individual's confidence in
      their ability to tolerate pain and participate in daily activities despite pain. The aim of
      this study is to determine the Turkish version, validity, and reliability of ''UW Concerns
      About Pain Scale''. 60 people with chronic low back pain will include in the study. In order
      to determine the reliability of the scale, the intraclass correlation coefficient (ICC) will
      be used to determine the level of the relationship between the results of the first and
      second measurements. Cronbach's alpha coefficient will be used for the homogeneity of the
      questions in the scale. For construct validity, the correlation coefficient will be used to
      determine the agreement between the Turkish version of Pain catastrophizing scale and,
      Turkish version of "Fear Avoidance Beliefs Questionnaire" and The ''UW Concerns About Pain
      Scale''.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        People with Chronic low back pain
      
Keywords: Concerns
Aripiprazole (Abilify®) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesized that combined pharmacotherapy using adjunctive aripiprazole of
      standard antidepressants would be associated with improved depression response in Major
      depressive disorder, especially in Quality of life.

      The investigators compare the mean changes in the quality of life between before add-on and 8
      weeks treatment of aripiprazole and between before add-on and 6 weeks treatment of
      aripiprazole.
    

Detailed description: 
      Previous study about quality of life measurement in patients with depression have been
      reported that quality of life have to be measured irrespective with the severity of
      depression because quality of life has some other aspect to depression.The investigators have
      designed a 6-week single blinded study with flexible dose aripiprazole augmentation, ranging
      from 2.5mg to maximum 20 mg (15mg for patients on fluoxetine or paroxetine), in patients who
      responded inadequately (a score of >18 on the MADRS) to first-line antidepressant
      pharmacotherapy. The investigators compare the mean changes from in the quality of life at 8
      weeks.
    

Intervention name(s): Aripiprazole 6-week group; Aripiprazole 8-week group
Intervention type(s): Drug; Drug
Other intervention name(s): Abilify®; Abilify®
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Zonisamide for the Treatment of Obstructive Sleep Apnea in Overweight/Obese Patients
Condition: Sleep Apnea; Obstructive Sleep Apnea; Obesity
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Obesity; Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      This RCT explores the efficacy of Zonisamide (Zonegran®)on overweight/obese in patients with
      moderate to severe obstructive sleep apnea. Patients will be randomized to receive
      zonisamide, placebo or nasal continuous positive airway pressure (nCPAP) during 4 weeks. A 5
      month open extension part will follow when patients in the tablet groups will all receive
      zonisamide. Patients in the open CPAP group will continue with CPAP treatment.

      Study hypothesis:

      Controlled pharmacological weight reduction with Zonisamide will result in elimination of OSA
      and OSA sequels more effectively than nCPAP due to incomplete compliance with the mechanical
      treatment and a lack of direct beneficial metabolic effects after nCPAP. Further it is
      hypothesized that zonisamide has a direct pharmacological effect on respiratory control
      during sleep by its carbonic anhydrase inhibitory effects and this will result in a reduction
      of sleep disordered breathing.
    


Intervention name(s): Zonisamide; Placebo; nCPAP
Intervention type(s): Drug; Drug; Device
Intervention description(s): Zonisamide (Zonegran®) tablets will be administered according to a forced stepwise weekly titration scheme with weekly 100 mg escalations from 100 to 300 mg daily according to the manufacturer Eisai Inc.
Other intervention name(s): Zonegran®; nCPAP - Nasal Continuous Positive Airway Pressure.; ResMed - S9 AutoSet™; ResMed - S8 AutoSet Spirit™ II
Intervention MeSH terms: Zonisamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Zonisamide; Zonegran; Obstructive Sleep apnea; Apnea; Respiration Disorders; Sleep Disorders; Obesity; Anti-Obesity Agents; Carbonic Anhydrase; Carbonic Anhydrase Inhibitors; Enzyme Inhibitors; Sulfonamides; Therapeutic Uses; Pharmacologic Actions
Body Water Content in Cyanotic Congenital Heart Disease
Condition: Heart Defects, Congenital
MeSH terms: Heart Defects, Congenital; Congenital Abnormalities
Study type: Observational

Summary: 
      Adults with cyanotic congenital heart disease have elevated levels of plasma proatrial
      natruretic peptide (proANP) which most likely results in chronic dehydration, leading to
      reduced oxygen transport to tissues and shortness of breath with activity. The purpose of
      this study is to characterize adults with cyanotic congenital heart defects with respect to
      their body composition (water and fat-free mass) and resting metabolic rates. The study
      consists of several measures of how much body water, fat and lean tissue a subject has, and
      measures the number of calories the subject's body uses at rest. Adult subjects with cyanotic
      congenital heart disease will be recruited along with healthy noncyanotic control subjects
      matched for age, gender, and body weight.
    


Observational model: Case-Control
Keywords: Cyanotic Congenital Heart Disease
Sulforaphane to Reduce Symptoms of Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if taking a sulforaphane nutraceutical versus a
      placebo will reduce symptoms of schizophrenia when used in addition to standard antipsychotic
      medications.
    


Intervention name(s): Sulforaphane Nutraceutical; Identical-appearing Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sulforaphane Nutraceutical 6 tablets by mouth daily; Identical-appearing Placebo 6 tablets by mouth daily
Other intervention name(s): Avmacol®
Intervention MeSH terms: Sulforaphane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Schizoaffective Disorder; Sulforaphane; Sulforaphane supplement
Effect of BIIL 284 BS on the Pharmacokinetics of Theophylline in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effect of multiple doses of BIIL 284 BS on the pharmacokinetics of a single
      dose of theophylline.
    


Intervention name(s): BIIL 284 BS; Theophylline; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Theophylline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Efficacy, Tolerability and Safety of LAS41004 Formulations in a Psoriasis Plaque Test
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Clinical investigation of anti-psoriatic efficacy and atrophy
    

Detailed description: 
      In this trial three concentrations of bexarotene in combination with a fixed concentration of
      betamethasone dipropionate, as well as monotherapy with bexarotene, will be investigated
      regarding their efficacy, tolerability and safety in patients with mild to moderate plaque
      psoriasis and will be compared with the vehicle and an active comparator.

      Since a side effect of the application of corticosteroids is skin atrophy, additionally three
      non-lesional test areas (not affected by psoriasis) on the volar forearm will be treated with
      the active reference product, one of the fixed combinations and the vehicle. Skin atrophy
      will be investigated by visual assessment and ultrasound at these test areas
    

Intervention name(s): LAS41004-IMP1; LAS41004 IMP2; LAS41004 IMP3; LAS41004 IMP4; LAS41004 IMP6; LAS41004 IMP5
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): daily topical application; daily topical application; daily topical application; daily topical application; daily topical application; once daily, topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: psoriasis plaque test; topical application; atrophy measure
"Effectiveness of Dual-Wavelength Laser Therapy in Third Molar Extraction Pain, Swelling, and Trismus"
Condition: Molar, Third; Low-level Laser Therapy
MeSH terms: Trismus
Study type: Interventional

Summary: 
      Objective: To investigate the effects of single session dual wavelength low dose laser
      therapy to be applied after third molar tooth extraction on postoperative pain, edema and
      physical activities.

      Materials and Methods: Thirty-six patients who applied for the extraction of a Class III and
      position B lower impacted wisdom tooth were included in the study. The patients were divided
      into 2 groups as laser and control group. Envelope selection method was used for
      randomization of patients. After the surgery, a single session of double wavelength low-dose
      laser therapy was applied to the patients. On the 2nd and 7th postoperative days, pain was
      measured with the VAS scale, edema was measured by face measurements of 3 different points,
      and quality of life was measured with the modified Posse scale.
    

Detailed description: 
      Objective and background: Pain, edema, and trismus are common problems after tooth
      extraction. Photobiomodulation therapy (PBMT) is frequently used as an adjunctive method to
      reduce these problems. However, there is no consensus in the literature regarding the type,
      power, session duration, and application frequency of the laser for this treatment method.
      The aim of this study is to examine the effectiveness of a single-session application of
      dual-wavelength PBMT (using a 904 nm GaAlAs infrared laser and a 650 nm red laser) on pain,
      edema, trismus, and the quality of life of patients following impacted mandibular third molar
      extraction.

      Methods: The study included patients whose impacted mandibular third molars were to be
      extracted for prophylactic purposes. The patients were divided into two groups as the PBMT
      group and the placebo control group. Pain, swelling, maximum mouth opening, and quality of
      life parameters of the patients were evaluated.
    

Intervention name(s): Dual wavelength low level laser; Placebo
Intervention type(s): Device; Device
Intervention description(s): Application of double wavelength low level laser to the related area after tooth extraction.; Only red light applied.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: hee primary outcome was postoperative pain, evaluated using the visual analogue scale (VAS) score at Baseline, for 7 days following surgery, postoperative swelling and maximum mouth opening values evaluated at 2nd and 7th days in subject treated for third molar surgery with piezoelectric surgery or rotating drills. The secondary outcomes chosen were changes in quality of life using a questionnaire form.
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: photobiomodulation,; Impacted third molar; Pain; Edema
The Effect of Z-338 in Subjects With Functional Dyspepsia
Condition: Functioanl Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 2

Summary: 
      Z-338; PhaseIIb, Single-centre, Randomized, Double-blind, Placebo-controlled, Parallel group
      study in Subjects with Functional Dyspepsia, evaluate the motility of gastro-duodenum by
      ultrasound
    


Intervention name(s): Z-338
Intervention type(s): Drug
Intervention MeSH terms: Z 338
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
An Exploratory Investigation of a CBD Supplement's Impact on Sleep, Stress, and Focus
Condition: Anxiety; Fear; Stress; Low Mood; Sleep
MeSH terms: Depression
Study type: Interventional

Summary: 
      A high-quality broad-spectrum cannabidiol supplement with a bio-terpene complex will be
      administered once daily. It is hypothesized that this supplement will lead to improvements in
      sleep, focus, and stress. Previous research supports that CBD supplementation provides
      support to the endocannabinoid system, allowing the brain to better control negative
      psychological outcomes like fear, stress, and negative mood states.
    


Intervention name(s): The Daily Supplement
Intervention type(s): Dietary Supplement
Intervention description(s): Each serving of the dietary supplement (defined as 1 softgel) contains the following formulation:
Organic Broad Spectrum Hemp Extract 35mg Bio-Terpene Complex 52mg Palm Monoglycerides Organic Hemp Seed Oil, Clove Bud Oil, Black Pepper Berry Essential Oil Curcumin (Turmeric Root) Essential Oil
Inactive ingredients: Organic Flaxseed Oil, Gel Shell (Modified Tapioca Starch, Glycerin, Purified Water, Maltitol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Anxiety; Fear; Stress; Low Mood; Sleep; Focus; Calmness