bioihbjkbjnl/mcl2 huggingface dataset:
Post-Traumatic Stress Disorder (PTSD) and Seroquel
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This 8 weeks study will investigate therapeutic responses to Seroquel pharmacotherapy in
      PTSD.
    

Detailed description: 
      An initial telephone interview will be conducted to determine if potential subjects meet the
      basic study requirements. If no obvious counterindications are present, subjects will be
      scheduled for a screening visit. After briefing the subjects on the reasons for the research,
      they will be given an opportunity to read the Informed Consent Form, approved by the
      Cambridge Health Alliance Institutional ReviewBoard, and to ask questions prior to signing
      it. Subjects will be given a copy of the signed Consent Form. Each subject will complete a
      standardized interview schedule designed to obtain personal and background data along with
      psychodiagnostic and psychometric evaluations. An open-label treatment will be utilized for
      all patients. Seroquel tablets will be flexibly dosed and begun at a target dose of 25 mg per
      day and taken over an 8 week period.
    

Intervention name(s): Seroquel
Intervention type(s): Drug
Intervention description(s): This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
Other intervention name(s): quetiapine
Intervention MeSH terms: Quetiapine Fumarate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Post-traumatic Stress Disorder; PTSD; Seroquel; fMRI
A Clinical Study in Children and Adolescents With Mild to Moderate Atopic Dermatitis
Condition: Mild to Moderate Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      To show therapeutic efficacy of Zarzenda cream compared to Elidel cream in children and
      adolescents with mild to moderate atopic dermatitis
    


Intervention name(s): Zarzenda; Elidel
Intervention type(s): Device; Drug
Intervention description(s): Topical cream, applied twice daily for three weeks; 1% cream, applied topically twice daily for three weeks
Intervention MeSH terms: Pimecrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: atopic dermatitis
Effects of Selective Inhibition of Cholesterol Absorption With Ezetimibe on Intestinal Cholesterol Homeostasis in Dyslipidemic Men With Insulin-resistance - a Pilot Study
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Insulin Resistance
Study type: Interventional
Phase: Phase 3

Summary: 
      Ezetimibe has been shown to inhibit cholesterol absorption and several lines of evidence from
      in vitro systems and animal models suggest that this effect is associated with an increase in
      low-density lipoprotein (LDL) receptor expression in the small intestine. The impact of a
      treatment with ezetimibe on intestinal gene expression and protein mass levels of LDL
      receptor and other key genes involved in intestinal cholesterol homeostasis will be examined
      in dyslipidemic men with insulin-resistance. In the present study, gene expression studies
      and protein mass levels will be assessed on duodenal biopsies by real-time polymerase chain
      reaction (rt-PCR) and liquid chromatography-mass spectrometry (LC-MS/MS), respectively. The
      primary objective of this proposal is to examine the effects of ezetimibe on intestinal gene
      expression (rt-PCR) and protein mass levels (LC-MS/MS) of LDL receptor in dyslipidemic men
      with insulin-resistance. The secondary objective is to examine the impact of ezetimibe
      treatment on intestinal gene expression and protein mass levels of sterol regulatory
      element-binding protein (SREBP)-2, Niemann-Pick C1-Like1 (NPC1L1), ATP binding cassette gene
      (ABCG)-5/8, proprotein convertase subtilisin/kexin type 9 (PCSK9) and
      3-hydroxy-3-methyl-glutaryl-CoA (HMG CoA) reductase.

      Primary hypothesis Treatment with ezetimibe 10 mg/day will significantly increase duodenal
      mRNA and protein mass levels of LDL receptor in dyslipidemic men with insulin-resistance.

      Secondary hypothesis Treatment with ezetimibe 10 mg/day will significantly increase duodenal
      mRNA and protein mass levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA reductase in
      dyslipidemic men with insulin-resistance.
    


Intervention name(s): Ezetimibe; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ezetimibe 10 mg/d for 12 weeks; Placebo for 12 weeks
Other intervention name(s): Ezetrol
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Relationship Between 24-hour IOP Pattern and the 24-hour Blood Pressure Pattern in Patients With POAG
Condition: Primary Open Angle Glaucoma; Normal Tension Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Low Tension Glaucoma
Study type: Interventional

Summary: 
      Interplay between the increasing IOP and decreasing blood pressure (BP) during the 24-hour
      period, especially in the nocturnal period, may lead to insufficient perfusion pressure of
      the optic nerve and contribute to the glaucomatous damage in adjunct to the antero-posterior
      vectorial mechanical impact on the lamina cribrosa, the translaminar pressure. Patients with
      progressive VF loss showed greater nocturnal BP dips than patients with stable VF. Reduced
      mean intraocular perfusion pressure (IOPP) was significantly associated with the extent of
      glaucomatous damage. How the nycthemeral IOP fluctuation influences glaucoma progression has
      not been studied in a prospective manner and remains to be elucidated.

      The purpose of this study is to assess the relationship between the 24-hour IOP fluctuation
      pattern and the 24-hour BP pattern in patients with primary open angle glaucoma (POAG). IOP
      fluctuations will be monitored with SENSIMED Triggerfish®, a portable investigational device
      using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours.
    


Intervention name(s): Sensimed Triggerfish®
Intervention type(s): Device
Intervention description(s): Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Glaucoma; IOP; Blood pressure; ECG
A Two-Week Study of the Efficacy and Safety of Mifepristone in the Prevention of Olanzapine-Induced Weight Gain
Condition: Weight-Gain Prevention
MeSH terms: Body Weight; Weight Gain
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a two-week study testing the efficacy and safety of mifepristone in the prevention of
      olanzapine-induced weight gain in healthy male volunteers by measuring changes in body weight
      and BMI.
    


Intervention name(s): Mifepristone
Intervention type(s): Drug
Intervention MeSH terms: Mifepristone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Study on Safety, Absorption and Metabolism of SYHA1402 Tablets in Healthy People
Condition: Diabetic Neuropathy Peripheral
MeSH terms: Diabetic Neuropathies; Peripheral Nervous System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial used single-center, randomized, double-blind, placebo-controlled, single-dose
      study.

      The trial planned to enroll sixty-two healthy volunteers. The subjects were allocated to
      seven dose groups, including 25 mg (4+2), 50 mg (8+2), 100 mg (8+2), 200 mg (8+2), 400 mg
      (8+2), 800 mg (6+2) and 1200 mg (6+2). Each dose group was allocated test drugs and placebos
      according to the proportion of subjects in the brackets mentioned above.
    


Intervention name(s): 25mg; 50mg; 100mg; 200mg; 400mg; 800mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): SYHA1402 25mg or Placebo 25mg; SYHA1402 50mg or Placebo 50mg; SYHA1402 100mg or Placebo 100mg; SYHA1402 200mg or Placebo 200mg; SYHA1402 400mg or Placebo 400mg; SYHA1402 800mg or Placebo 800mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Switching Study From Warfarin to Rivaroxaban
Condition: Venous Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study objective is to investigate the pharmacodynamics (effects of a drug product) when
      switching the treatment from warfarin to rivaroxaban.

      84 young, healthy subjects will participate; they will be treated following a randomized,
      parallel-group (Treatments A, B, and C), placebo-controlled (Treatment B), and single-blind
      (Treatments A and B) design.

      The first two groups (A, B) will receive warfarin for approximately one week to adjust their
      blood coagulation values to a specific level, i.e. to maintain an INR (international
      normalized ratio) of 2.0 - 3.0. This range is commonly used for long-term anticoagulant
      treatment.

      The first group (A) will receive rivaroxaban for four days, the second group (B) will take
      placebo. On the last day, all subjects in groups A and B will receive vitamin K to neutralize
      the effects of warfarin. The third group (C) will not undergo prior treatment with warfarin
      but will receive rivaroxaban for four days.
    


Intervention name(s): Warfarin (Coumadin); Rivaroxaban (Xarelto, BAY59-7939); Placebo; Vitamin K (Konakion)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Days -6 and -5: 10 mg warfarin (Coumadin) once daily, dosage lower if the INR is already high on day -5; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin (Coumadin) once daily, dosage depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Days 0 to 3: 1 tablet placebo, identical to active tablet; Day 5: 10 mg vitamin K (Konakion) once daily
Intervention MeSH terms: Vitamin K; Vitamin K 1; Warfarin; Rivaroxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Rivaroxaban; Xa-Factors; Warfarin; Thrombosis; Embolism
Streptococcus Mutans Reduction Early Mother-infant Transmission
Condition: Pregnant Women
Study type: Interventional
Phase: Phase 4

Summary: 
      Evidence exists on the vertical transmission of Streptococcus mutans from the mother to her
      children. This transmission can be prevented by maintaining maternal oral health during
      pregnancy.
    

Detailed description: 
      The aim of this study was to evaluate the enhancing effect of 1% chlorhexidine varnish
      together with silane fluoride re-mineralizing varnish and oral health promotion strategy on
      the reduction of S. mutans counts in saliva of pregnant women and the early mother-infant
      transmission until the first six months of age of the newborn. Methods: An open, random
      clinical trial of parallel groups was performed. 56 pregnant women free of caries were
      studied prospectively and longitudinally since the third trimester of gestation until 6
      months after giving birth, the newborns were also assessed until reaching 6 months of age.
      Two groups were formed assigning 28 women to each intervention group. G-I received 0.1%
      silane fluoride applied as varnish in each visit. G-II women's teeth were coated with 0.1%
      silane fluoride and 1% chlorhexidine. For the primary culture, CRT Bacteria® system
      (Ivoclar-Vivadent™) was used for the growth and identification of cariogenic Streptococci.
      Identification of S. mutans was performed through PCR. The DNA of the isolates identified
      molecularly as S. mutans was used for a second PCR reaction using the arbitrary primer OPA-O2
      to determine the homology among the samples of isolated bacteria from the mother-child pair.
    

Intervention name(s): Pregnant women to whom applied silane fluoride; Pregnant women to whom applied silane fluoride + 1% chlorhexidine
Intervention type(s): Drug; Drug
Intervention description(s): Pregnant women who received 0.1% silane fluoride applied as varnish in the teeth.; Pregnant women who received silane fluoride + 1% chlorhexidine applied as varnish in the teeth.
Other intervention name(s): Fluor Protector, Ivoclar Vivadent AG™; Fluor Protector, Ivoclar Vivadent AG™ + 1% chlorhexidine
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Random clinical trial of parallel groups
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: chlorhexidine varnish; silane fluoride; Streptococcus mutans; vertical transmission
The Immediate Effect of Mobilisation With Movement in Amateur Futsal Athletes With Chronic Ankle Instability
Condition: Ankle Injuries and Disorders
MeSH terms: Ankle Injuries
Study type: Interventional

Summary: 
      Chronic ankle instability (CAI) is an increasingly prevalent condition among futsal athletes.
      Mobilization with Movement (MWM) is a conservative rehabilitation strategy commonly used in
      this condition. Even so, the effects of two MWM dorsiflexion techniques on sports performance
      are not known. The aim is to analyze the immediate effect of two MWM techniques on the
      dorsiflexion range of motion, the dynamic balance and the performance variables in futsal
      athletes with CAI. Also, to analyze the impact of performing them in a different order.
    


Intervention name(s): Mobilisation With Movement 1; Mobilisation With Movement 2; Placebo
Intervention type(s): Procedure; Procedure; Other
Intervention description(s): Application of a sustained passive accessory movement to a joint (talus or fibula) while the patient actively performs a forward lean/lunge that was previously limited.
3 sets of 10 repetitions of a glide applied to the talus were performed, followed by 3 sets of 10 repetitions of a glide applied to the fibula.; Application of a sustained passive accessory movement to a joint (talus or fibula) while the patient actively performs a forward lean/lunge that was previously limited.
3 sets of 10 repetitions of a glide applied to the fibula were performed, followed by 3 sets of 10 repetitions of a glide applied to the talus.; The Placebo group participants performed the same number of sets and repetitions (6 sets of 20 repetitions) of lean/lunge forward into dorsiflexion, without any glide application.
Other intervention name(s): Mulligan; Mulligan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Brain Changes in Severely Depressed Patients Before and After Treatment With Electroconvulsive Therapy
Condition: Severe Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      Electroconvulsive therapy (ECT) is a non-pharmacological treatment used in resistant
      depression whose effectiveness has been demonstrated. However, the brain mechanisms
      underlying this therapeutic effect remain unclear. Many animal studies show a neurotrophic
      action of ECT on the hippocampus: increased neurogenesis, synaptogenesis, proliferation of
      glial cells. In addition, functional imaging of "resting state" type have shown, among
      depressed patients after ECT, increased functional connectivity . These results were
      reinforced by the recent work of Perrin (2012). In view of this a priori contradictory, it
      seems appropriate to continue research neuroanatomical correlates subtending neurofunctional
      processes responsible at the same time improving the clinical depressive. The investigators
      suggest using an original technique never used in this type of population: Functional
      magnetic resonance imaging (fMRI) or multimodal structural-functional. This method will allow
      us to study the impact of ECT on brain structures involved in major depressive disorder:
      hippocampus.
    


Intervention name(s): 3T MRI
Intervention type(s): Device
Intervention description(s): Four visits will be conducted during the prospective follow during which will be carried out a 3T MRI examination, assessment of assessment of depressive symptomatology and anterograde memory: within 7 days prior to the first session of ECT, within 48 hours after the first ECT session, within 48 hours after the first effective ECT session and within 10 days of the last session of ECT.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ECT; Diffusion Tensor Imaging (DTI); fMRI
Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to confirm the efficacy of a single oral 900 mg dose
      of nolasiban versus placebo to increase the ongoing clinical pregnancy rate at 10 weeks
      post-embryo transfer (ET) day.
    

Detailed description: 
      The study is a prospective, randomised, parallel group, double-blind, placebo-controlled,
      Phase 3 study to confirm the efficacy and the safety of nolasiban versus placebo to increase
      pregnancy and live birth rates in 820 women undergoing fresh single blastocyst transfer
      following in vitro fertilisation (IVF) or intra-cytoplasmic sperm injection (ICSI).
    

Intervention name(s): Nolasiban; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Nolasiban single oral administration; Placebo single oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IVF; ICSI; ART; ET
Metabolic Acidosis and Vascular Function in Patients With Chronic Kidney Disease
Condition: Metabolic Acidosis; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Acidosis
Study type: Interventional

Summary: 
      Cardiovascular disease (CVD) is the leading cause of death in patients with chronic kidney
      disease (CKD) and large artery damage is a major factor that contributes to death. Metabolic
      acidosis is a common complication of CKD resulting from an inability of the diseased kidney
      to excrete the daily dietary acid load and it is associated with all-cause mortality in
      patients with CKD. However, the effect of treatment of metabolic acidosis with oral sodium
      bicarbonate on endothelial dysfunction and arterial stiffness in patients with CKD has not
      been evaluated. The investigators propose a prospective, randomized, controlled, open-label
      14-week crossover pilot study examining the effect of treatment of metabolic acidosis with
      oral sodium bicarbonate on vascular endothelial function in 20 patients with CKD stage IV
      with metabolic acidosis.
    


Intervention name(s): Sodium bicarbonate; Control
Intervention type(s): Drug; Other
Intervention description(s): Subjects will be treated with oral sodium bicarbonate two to three times per day for a goal serum bicarbonate (HCO3-) of ≥ 23 meq/L.; subjects will receive no treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vascular endothelial cells
The Effect of Exercise Training on Cardiac Structure and Function
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Exercise training, as part of cardiac rehabilitation, is effective in improving functional
      capacity and quality of life in patients with coronary artery disease. Other cardiovascular
      and non-cardiovascular benefits have been reported, namely in glucose metabolism, skeletal
      muscle function, oxidative stress, vascular function, pulmonary circulation,
      ischaemia-reperfusion lesion and ventricular remodelling.

      However, the benefit of exercise training on systolic and diastolic function is controversial
      especially after acute myocardial infarction where no longitudinal study has evaluated
      diastolic function using modern echocardiographic parameters.

      The hypothesis is that a structured program of exercise training can improve systolic and
      diastolic function in patients after myocardial infarction.
    


Intervention name(s): Structured exercise training
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Major Abdominal Surgery
Condition: Major Upper or Lower Abdominal Surgery
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate dosages of ARX-F01 (opioid pain medication) versus a
      placebo (or sugar pill) for the treatment of post-operative pain in subjects following
      abdominal surgery. We hypothesize that subjects receiving placebo will have poor pain relief
      and will drop out of the study sooner and more often than the ARX-F01 treated subjects.
    


Intervention name(s): Oral sufentanil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral dosage of sufentanil; Oral dosage of placebo
Intervention MeSH terms: Sufentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Aging and Immobilisation on Muscle
Condition: Healthy
Study type: Interventional

Summary: 
      The debilitating effects of immobilisation on muscle strength and size in young individuals
      are well documented. Moreover, sarcopenia has long been recognized as a major cause of muscle
      strength loss in old age, however, changes in muscle mass and architecture with
      immobilisation in the elderly has not previously been investigated. This is contrasted by the
      fact that the elderly population more often undergoes periods of immobilization and disuse
      not only due to joint pain but also due to a higher degree of co morbidity and
      hospitalisation.The purpose of the present study was to compare the effect of a 2 week period
      of unilateral immobilisation on the physiological muscle cross sectional area, maximal
      isometric muscle strength, specific force, muscle fascicle length and muscle fibre pennation
      angle in young and old healthy men.
    


Intervention name(s): 2 weeks of unilateral immobilisation and 4 weeks of resistance training; 2 weeks of unilateral immobilisation and 4 weeks of resistance training
Intervention type(s): Other; Other
Intervention description(s): 2 weeks of whole leg casting (side randomized)followed by 4 weeks of unilateral resistance training. The non-imm side served as a within-subject control; 2 weeks of unilateral whole leg casting (side randomized)followed by 4 weeks of unilateral resistance training. The non-imm side served as a within-subject control
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: immobilisation; aging; resistance training; atrophy; The effect of immobilisation in elderly compared to young individuals