bioihbjkbjnl/mcl2 huggingface dataset:
Study to Investigate the Effects of Food on Relative Bioavailability of ABP-671 Tablets in Healthy Subjects
Condition: Gout; Food-drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, open-label, single-dose, 2-way randomized crossover design in which
      12 healthy subjects will be randomized to 1 of 2 treatment sequences (AB or BA). Treatments A
      and B will consist of single oral dose of tablet formulation (1.0 mg as 1 x 1.0 mg) in the
      fasted and fed state administered with approximately 240 mL of water. Each period will be
      separated by a washout interval of 4 days.
    


Intervention name(s): ABP-671
Intervention type(s): Drug
Intervention description(s): ABP-671 Tablet 1.0 mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Reliability, Sensitivity and Validity of the 6 Minute Step Test in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Chronic Obstructive Pulmonary Disease (COPD) leads to a reduction in exercise capacity that
      affects the quality of life and increases mortality of these patients. So, exercise tests are
      considered as an essential component of the clinical evaluation of the patients with COPD.
      The objective of this study is to evaluate the reproducibility sensitivity and validity of
      the Six Minute Step Test (6MST) in patients with COPD and in health volunteers, and verify
      its relation with the "Body-Mass Index, Airways Obstruction, Dyspnea and Exercise Capacity"
      Index (BODE). This Observational, Transversal, Prospective study will be conducted in the
      "Special Unit of Respiratory Physiotherapy", of the "Federal University of São Carlos". To
      participate in this study, 120 subjects, both gender, will be invited and will be allocated
      in five groups: Group I (30 healthy young subjects of 17 to 27 years old), Group II (30
      healthy elderly individuals of 60 to 75 years old), and patients COPD, 60 to 80 years old,
      with mild, moderate, severe and very severe obstruction determined by the forced expiratory
      volume in one second (FEV1) by forced vital capacity (FVC) relation "FEV1/FVC" <70% and FEV1
      in predict percentage < 80% composing the Group III (20 COPD patients in GOLD stage I), Group
      IV (20 COPD patients in GOLD stage II) and Group V (20 patients COPD stages III and IV). All
      subjects will be submitted to body composition and anthropometric assessment, pulmonary
      function test, three 6-minutes walk test (6MWT) and three 6MST. Furthermore, the patients of
      the groups III, IV and V will answer the Modified Medical Research Council (mMRC) scale, and
      BODE index will be calculated to each of them.
    


Intervention name(s): Six-minute Step Test
Intervention type(s): Other
Intervention description(s): The patients underwent a test where they need to step up and down a 20cm test during six minutes.
Other intervention name(s): Exercise Test
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Exercise Test; Reproducibility of Results; Mortality
Topical PDT Cream Without Irradiation Source in the Acne Treatment
Condition: Acne, Photodynamic Therapy
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      In this study, the investigators are going to compare the clinical effect and safety of
      topical application of 1.5% Butenyl ALA cream formula without light source irradiation in the
      treatment of acne.
    


Intervention name(s): Topical application of 1.5% Butenyl ALA; Topical application of sham control
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Microneedling Plus the Universal Peel For Acne Scarring
Condition: Acne Scarring
MeSH terms: Cicatrix
Study type: Interventional

Summary: 
      Acne is a prevalent disorder mostly witnessed in adolescents, but can be seen in adults.
      Early treatment is imperative to reduce acne scarring which can appear with atrophic lesions,
      and depending on the skin type, significant erythema (redness) or post-inflammatory
      hyperpigmentation. A multi-modality approach to treatment is necessary when dealing with the
      aforementioned types of lesions. Pharmacologic management is essential, but safe procedural
      therapies are also necessary specifically with darker skinned individuals.

      Percutaneous collagen induction therapy (PCIT) is a non-invasive treatment achieved by using
      a micro-needling device, which is safe and effective in causing "micro-wounds" into the
      dermis thereby initiating wound healing followed by collagen production. This is an ideal
      treatment for acne scarring, re-texturizing of the skin, and hyperpigmentation for all skin
      types . Currently there are very few studies evaluating the safety and efficacy of
      microneedling and chemical peels in skin types III-VI.

      The aim of this study is to evaluate the effects of the combination of microneedling and
      chemical peel for the treatment of acne scars in skin types III-VI.
    


Intervention name(s): Universal Peel; Microneedling; Post-Microneedling Skin Care; Post-Universal Peel Skin Care
Intervention type(s): Drug; Procedure; Drug; Drug
Intervention description(s): Universal Peel: is a chemical peel consisting of a mild acid solution. (5 min Peel and 5 min Retinol); Microneedling: is a device for all skin types that creates micro "injuries" in the dermis (layer of the skin underneath the outermost layer) in an attempt to trigger new collagen (natural component of skin tissue) production for smoother, firmer and younger-looking skin.
For this protocol, the needle depth will be increased over the 3 sessions:
Forehead: 0.75 mm, 0.85 mm, 1.0 mm. Cheeks/Chin: 1.0 mm, 1.5 mm, 2.0 mm.
Each Session: Microneedling procedure on Day 1, followed by skin care regimen; On Day 1 (after Microneedling procedure):
Gentle Antioxidant Soothing Cleanser daily
Soothing Recovery Ointment and Sheer Physical Sunscreen
On Day 2-7:
AM: Physical sheer sunscreen and recovery ointment
PM: Retinol/Vitamin C in the evening and soothing recovery ointment
On Day 7:
AM: BD Hydrating Day/Night Cream
PM: Retinol and Vitamin C and the BD Hydrating Day/Night Cream (if necessary); Gentle Antioxidant Soothing Cleanser daily
Physical Sunscreen daily
Soothing recovery ointment fortified with silver only when peeling occurs
After completely peeling, vitamin c product in the morning and the retinol in the evening
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
LEO 22811 - Single Dose Bioavailability Study of Tablet Versus Oral Solution in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this phase 1 study is to determine the relative bioavailability and
      pharmacokinetics following single oral dose administration of LEO 22811 solution compared to
      LEO 22811 tablet in healthy male subjects as well as to determine the effect of food on the
      single oral dose pharmacokinetics of LEO 22811 tablet in healthy male subjects.
    


Intervention name(s): LEO 22811
Intervention type(s): Drug
Intervention description(s): Oral administration of solution and tablet.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Anodal Transcranial Direct Current Stimulation and Cognition in Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Pervious literature shows the effects of tDCS and RehaCom on cognition in chronic stage of
      stroke and only short-term effects were seen, but detailed evidence-based study on cognition
      in subacute and acute stages of stroke is spare and there is limited number of studies are
      available on effects of tDCS in cognition in both acute and subacute stages of stroke. Some
      polite studies were done in acute stage of stroke and only short-term effects of tDCS were
      evaluated along with other outcome measures including upper and lower limb motor recovery,
      balance and improving activity of daily living. The long-term effects of transcranial direct
      stimulation only for the improvement of cognition in subacute stage of stroke are yet to be
      seen. This study will help us in evaluating the long-term effects of aTDCS and RehaCom
      cognitive therapy on cognition in subacute stage of stroke.
    

Detailed description: 
      Previous literature showed that, the brain has a capacity to recover the loss that comes
      after brain damage within subacute stage, as in this stage there is high
      excitation-inhibition phenomena in neural circuit, this excitation-inhibition spectacles may
      reflect to upsurge the activity of neurotransmitter concentration within cortex that put
      subtle effect for developing neural plasticity.

      More innovative therapies are used worldwide in patient's cognitive rehabilitation after
      stroke, for cognitive training including physical movement, paper-and-pencil activities,
      manipulatives training programs or other aids such as playing cards or a combination of
      multiple training, along with transcranial direct current stimulation (tDCS) and RehaCom
      cognitive therapy which shows significant effects with (p < 0.05) in acute and chronic stages
      of stroke. Most of the studies used a different type of therapy in therapeutic protocols for
      other functional improvement including motor recovery exercises for both upper and lower limb
      balance training, postural stability exercises, manipulative training programs with
      significant improvement (p < 0.05) in real time (tDCS)
    

Intervention name(s): Anodal TDCS; Sham Anodal TDCS
Intervention type(s): Other; Other
Intervention description(s): RehaCom software is a computer assisted cognitive rehabilitation, it targets six programs of brain including attention, memory, and higher executive function, visuo-motor abilities, visual filed, vocational abilities, each module is divided into further subsections there is 36 total subsections, we will work on 6 subsections in every week.
The aTDCS device is a battery operated, with a pair of rubber conductive electrodes (size 7×5cm) enclosed with sponge saturated pockets (pads).; rehacom cognitive therapy will be provided to this group participants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Microvascular and Antiinflammatory Effects of Rivaroxaban Compared to Aspirin in Type-2 Diabetic Patients With Subclinical Inflammation and High Cardiovascular Risk
Condition: Type 2 Diabetic Patients
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to investigate microvascular and antiinflammatory effects of Rivaroxaban compared to
      low dose aspirin in type 2 diabetic patients.

      Especially patients with cardiovascular disease and subclinical inflammation are in the focus
      of interest.
    


Intervention name(s): Rivaroxaban; Aspirin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Aspirin; Rivaroxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phthalate Esters and Childhood Obesity
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Observational

Summary: 
      Phthalate esters have been considered closely related with childhood obesity, but the
      existing studies revealed inconsistent results. This study was desigened to investigate the
      association between phthalate esters and childhood obesity in China.
    

Detailed description: 
      The physical activity, dietary intake and the levels of urine phthalate metabolites of
      children were detected, and the associations between these 3 factors and childhood obesity
      were analyzed.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Students aged 6-8 years from monitoring schools in Shenzhen, China.
      
Biospecimen description: 
      urine sample
Efficacy of Whole-body Vibration on Balance Control, Postural Stability and Mobility After Thermal Burn Injuries.
Condition: Thermal Burn
MeSH terms: Burns
Study type: Interventional

Summary: 
      This study will be conducted to investigate the effect of whole-body vibration device on
      Balance control, postural Stability and mobility after thermal burn injuries.
    

Detailed description: 
      40 patients with deep second-degree burn involving the lower limbs and trunk (TBSA: 35-40%),
      will be randomly assigned either into the experimental group, received whole body vibration
      (WBV) plus the routine physical therapy program or the control group, received the same
      routine physical therapy program. All treatment interventions will be applied at a frequency
      of three sessions per week for 8 weeks. Anteroposterior stability (APS), Medial lateral
      stability (MLS), Time up and go test (TUG) test, and Berg balance scale will be the outcome
      measures of the study.
    

Intervention name(s): whole body vibration device; routine physical therapy treatment
Intervention type(s): Device; Other
Intervention description(s): 20 patients will receive vibration training on vibration platform (Power Plate International, Irvine, California, USA) at a frequency of 25-30 Hz and amplitude of 3-5mm, plus traditional physical therapy program 3 sessions per week for total period of 8 weeks. The total duration of the WBV training stimulus will 10 min in first week and progress gradually to 25 min in the 8th week with regular increase by 5 minutes after each 2 successive weeks; The program consists of 60 minutes supervised and individualized stretching exercise to all involved muscles followed by strengthening for affected muscles, mobilizing exercise for the joints involved to increase the joint range of motion, in addition to scar management techniques including pressure garments, inserts, and physical agent modalities , to avoid scar or contracture formation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study Comparing Plate Stabilization to Conservative Treatment in Midshaft Clavicle Fractures
Condition: Clavicle; Fracture
MeSH terms: Fractures, Bone
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to find whether to operate or treat conservatively dislocated
      midshaft clavicle fractures.
    

Detailed description: 
      Midshaft clavicle fractures are common comprising 2% of all fractures and 35% to 45% of all
      shoulder girdle injuries in adults. Old-established treatment practices, based on no
      randomised controlled trials, are used for clavicle fractures. By tradition, midshaft
      clavicle fractures have been treated conservatively with arm immobilized to a sling for few
      weeks. The goal of treatment is to restore painless function of the upper extremity.

      There have been some recommendations for operative treatment, such as skin compromising in
      fracture area, open fracture, floating shoulder, neurovascular symptoms in upper extremity,
      or multiple injuries. Recently, increasing interest has emerged in the surgical treatment.
    

Intervention name(s): Operative treatment; Non-operative treatment with arm immobilised to a sling
Intervention type(s): Procedure; Procedure
Intervention description(s): Fracture stabilization with stainless steel reconstruction plate and screws. After the operation arm is immobilized to a sling for three weeks. Pendulum movements are allowed immediately.; Arm is immobilised to a sling for three weeks. Pendulum movements are allowed immediately.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: clavicle fractures; midshaft; dislocated; operative treatment; conservative treatment; non-operative treatment; randomized controlled trial; bone plates
Bioavailability Study of SPARC001 (Study 2) in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to determine the relative bioavailability, safety and
      tolerability of SPARC001 and Reference001 in healthy, adult, male and female subjects
    


Intervention name(s): SPARC001 type I; SPARC001 type II; Reference001 type I; Reference001 type II
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Treatment type I; Treatment type II; Hydrocodone-acetaminophen; Hydrocodone Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Orthostatic Tolerance in Mamma Cancer Patients After Anaesthesia
Condition: Breast Cancer
Study type: Observational

Summary: 
      The investigators want to investigate the effect of anaesthesia, on the ability to maintain
      upright posture immediately after surgery in mamma cancer patients.

      The investigators hypothesis is, that a standard anaesthesia does not effect the ability to
      maintain upright posture right after surgery.
    

Detailed description: 
      It is known, that patients undergoing major surgery have problems maintaining upright posture
      after major surgery. This can be due to fall in bloodpressure, with symptoms like dizziness,
      nausea/vomiting and fainting.

      With this investigation, we want to prove that anaesthesia is not the decisive factor, in
      patients ability to maintain upright posture after surgery.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Mammasurgery patients
      
Keywords: Mammae cancer patients
PREDICTIVE IMMUNOLOGICAL STUDY OF RECURRENT ABORTIONS AND IMPLANTATION FAILURE
Condition: Maternal-Fetal KIR-HLA-C Compatibility
MeSH terms: Abortion, Habitual
Study type: Observational

Summary: 
      The involvement of the immune system in the process of implantation and its modulation as a
      therapeutic line in these alterations, failure of implantation and repetition abortion are
      controversial and make it necessary to conduct clinical studies properly led and with a study
      population chosen by strict criteria in order to better understand the involvement of the
      different innate and adaptive immune mechanisms in the field of reproductive medicine and
      especially in clinically expressed failures recurrent implantation failure and recurrent
      abortions.
    

Detailed description: 
      A prospective pilot study is proposed in patients with recurrent implantation failure and
      recurrent abortions undergoing assisted reproductive techniques.

      The main objective of this study is to determine the involvement of key effectors of innate
      immune response in the endometrium that induces a pro-inflammatory response, and to be able
      to know in particular what is the distribution of KIR receptors in the uNK and the HLA-C
      typing in patient-mother, egg/semen donors, male-father, abortive remains, live newborns.

      To this end, the distribution of KIR and HLA-C receptors will be studied two arms/patient
      groups, divided from a population chosen according to inclusion/exclusion criteria:

        -  Group I: group recurrent abortions.

        -  Group II: group recurrent implementation failure. The study population will include
           subjects of older age (aged between 18 and 37 years) who will be divided into 2 total
           Study Arms N x 200 (n x 100 for each arm).
    

Intervention name(s): HLA-C and KIR determination for patients, couples, oocyte or semen donors, abortive tissue and newborn.
Intervention type(s): Diagnostic Test
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with a history of recurrent abortion (more than 3 idiopathic involuntary abortions)
        or recurrent implantation failure (more than 3 failures of IVF cycles with good quality
        embryos or more 2 failures in cycles with donor eggs) that will undergo a cycle assisted
        reproduction
Safety, Tolerability and Host Response to Lactobacillus Johnsonii
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this research study is to determine the effects of the probiotic,
      Lactobacillus johnsonii N6.2, on safety, gastrointestinal function, wellness, fecal bacteria
      and blood biomarkers in healthy individuals.
    

Detailed description: 
      Healthy adult volunteers from 18-50 years of age will be recruited through the University of
      Florida and randomly distributed into two groups. This study is divided into 3 phases:
      baseline, intervention (study treatment) and washout. Participants will receive either the
      probiotic or placebo during the intervention phases. During the baseline phase, blood and
      fecal samples will be collected about 1 week before intervention initiation. On the day of a
      scheduled blood draw, the participant will need to arrive fasted overnight, and a light
      breakfast will be provided after blood draw. Starting on day 1 of the intervention phase, a
      second baseline blood sample will be collected and the participant will begin the study
      intervention (probiotic or placebo). Participants will consume 1 capsule (probiotic or
      placebo) daily for 8 weeks, and blood and stool samples will be collected and processed (on
      or around weeks 2, 4 and 8 of the intervention phase). A Fisher Scientific commode specimen
      collection system will be provided for stool collections. The stool collection kit may be
      taken home (participants will be asked to drop off the stool within 4 hours of defecation)
      for fecal sample collection or may use the restroom in the clinical lab at the Food Science
      and Human Nutrition Building in which kits will be provided for use. In the wash-out phase,
      participants will not consume the capsule (either the probiotic or placebo), but will provide
      blood and stool samples (on or around week 12). Throughout the study, participants will
      provide a total of 5 stool samples and 6 blood samples. Participants will be asked to
      complete daily and weekly questionnaires throughout all phases of the study, which will ask
      about quality of life (physical functioning, mental functioning, level of sleep, etc.),
      gastrointestinal function, and dietary intake. These assessments will be self-reported via
      online questionnaires. In the event that internet access is not available for a portion of
      the study, paper copies of the questionnaires may be provided.
    

Intervention name(s): L. johnsonii N6.2; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): L. johnsonii N6.2 10^10 CFU in capsule form administered for 8 weeks; Encapsulated starch placebo administered for 8 weeks
Other intervention name(s): Lactobacillus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: safety; tolerability