bioihbjkbjnl/mcl2 huggingface dataset:
MEV to Block the Posterior and Lateral Cords of the Infraclavicular Brachial Plexus
Condition: Shoulder Disease; Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators have recently shown that LSIB in combination with a suprascapular and a
      cervical plexus block is a very good alternative for arthroscopic shoulder surgery. However,
      the investigators believe the total volume of local anesthetic for LSIB may be reduced. For
      shoulder surgery there is no need to block the medial cord and the investigators therefore
      hypothesize a significantly lower MEV95% by applying a selective lateral and posterior cord
      block
    

Detailed description: 
      The MEV for a successful block in 50% of the participants will be determined by using the
      staircase up-and-down method introduced by Dixon and Massey. Logistic regression and probit
      transformation will be applied to estimate the MEV for a successful block in 95% of the
      participants.
    

Intervention name(s): Ropivacaine
Intervention type(s): Drug
Intervention description(s): Minimum effective volume
Intervention MeSH terms: Ropivacaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Gingival Depigmentation by Diode Laser
Condition: Laser-induced Hypopigmentation
MeSH terms: Hypopigmentation
Study type: Interventional
Phase: Phase 1

Summary: 
      Physiologic gingival pigmentation(PGP) is the most common type of gingival pigmentation and
      cosmetic concern particularly in gummy smile patients. Laser therapy is an effective and
      noninvasive treatment option. The aim of this study was to evaluate the efficacy of diod
      laser on the treatment of PGP in patients.
    

Detailed description: 
      Preoperative and postoperative photographic and clinical observations about the gingival
      melanin pigmentation were made according to Dummett-Gupta Oral Pigmentation Index scoring
      criteria given by Dummett C.O. in 1964 The investigators classified pigmented gingiva in
      patients as:

        1. Mild:Pink to slightly brown

        2. Moderate:Deep brown or black

        3. Severe:Mixed in color Score in each tooth was taken including one full inter dental
           papilla. Observations were made in natural light. The assessment of the scoring of the
           pigmentation index were done by all the three examiners, and the agreed upon score was
           assigned to prevent individual variations.

      The investigators compared the intensity of pigmentation in each patient in recall sessions
      after 1month and 3mounth postoperative.
    

Intervention name(s): 810 Diode Laser
Intervention type(s): Device
Intervention description(s): The 810-nm diode laser has energy and wavelength characteristics that specially target the soft tissues. It has an affinity for hemoglobin and melanin, so it is an excellent soft tissue laser and is applicated for cutting and coagulating gingival tissue.Today,sparse studies have been published assessing physiologic gingival pigmentation using diode laser,therefore the aim of this study was to evaluate the effect of diode laser on the treatment of gingival pigmentation in adult patients.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigation of Interactions Between Faldaprevir, Itraconazole, Atorvastatin and Rosuvastatin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the effect of steady-state itraconazole on the pharmacokinetics of
      steady-state of faldaprevir and the effect of steady-state of faldaprevir on the single-dose
      pharmacokinetics of atorvastatin as well as the effect of steady-state of faldaprevir on the
      single-dose pharmacokinetics of rosuvastatin
    


Intervention name(s): Itraconazole; Atorvastatin; Faldaprevir; Rosuvastatin; Faldaprevir
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): twice daily; single dose; once daily; single dose; once daily
Intervention MeSH terms: Itraconazole; Atorvastatin; Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fermented Grape Combined With Fruits and Vegetables Drink on Anti-aging and Anti-inflammatory
Condition: Skin Condition
MeSH terms: Skin Diseases; Disease
Study type: Interventional

Summary: 
      60 subjects were recruited and divided into placebo group and fermented grape drinks group.
    

Detailed description: 
      In this study, using a fermented grape drinks made of fermented grapes with fruit and
      vegetable powder to explore whether it can improve the skin's condition and achieve
      anti-inflammatory effects. Sixty subjects were recruited and divided into placebo group and
      fermented grape drinks group. After drinking for 8 weeks, skin test and blood biochemical
      analysis were performed.
    

Intervention name(s): placebo group; fermented grape drinks
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): subjects drank 50 ml , 1 bottle a day for 8 week; subjects drank 50 ml , 1 bottle a day for 8 week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Study to Evaluate Tolerability and Safety of FXFM244 and to Monitor Clinical Effect in Acne Vulgaris Patients
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the tolerability and safety and to determine whether
      FXFM244 Antibiotic Foam is effective in the treatment of Acne Vulgaris.
    

Detailed description: 
      This is a phase IIa prospective, multicenter, randomized, double blind, placebo controlled,
      parallel group, dose range finding clinical study to evaluate the safety, tolerability and
      efficacy of Minocycline Foam 1% and 4% for the treatment of Acne Vulgaris.

      The study consists of a screening / baseline visit, a treatment period where patients will be
      treated topically on the facial skin areas affected by acne twice daily for 12 weeks,
      followed by a post-treatment follow up visit 4 weeks after end of treatment. The first dose
      will be applied in the presence of the study investigator or his assignee. Subsequent
      applications will be made by the patients.
    

Intervention name(s): Topical Minocycline Foam FXFM244
Intervention type(s): Drug
Intervention description(s): Topically applied once a day.
Other intervention name(s): FXFM244 antibiotic foam
Intervention MeSH terms: Anti-Bacterial Agents; Minocycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acne; Acne Vulgaris; Topical; Minocycline; Foam; Phase II
Safety and Efficacy of Autologous Bone Marrow Stem Cells in Treating Spinal Cord Injury
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The projected data related to the burden of spinal cord injuries induced limb paralysis in
      India is quite alarming. This is attributed to the rapid industrialization and economical
      development in the country. Increase in vehicular traffic has caused numerous road traffic
      accidents. Rapid increase in populations, development in the computer technology and real
      estate business lead to construction of huge buildings which indirectly adds to the injuries
      due to fall. Spinal cord injuries could not be treated adequately with the prevailing
      treatment modalities. In view of this, there is definitely an urgent need for finding
      different methods of treatment for these patients who cannot undergo established modalities
      of treatment or these have been tried unsuccessfully. Since a large number of these patients
      will loose their productive life and at the prime of their lives, one such alternate therapy,
      which seems to offer some promise, is "stem cell" therapy, which has been well studied and
      published in prestigious journals.

      In our present study, we want to evaluate the safety and efficacy of autologous bone marrow
      derived stem cells surgically transplanted directly into the lesion site with glial scar
      resection for 8 indian patients of chronic spinal cord injury and intra-thecal injection for
      4 indian patients of acute and subacute injury.
    


Intervention name(s): laminectomy; Intrathecal
Intervention type(s): Procedure; Procedure
Intervention description(s): surgical laminectomy with glial scar resection; direct into the CSF through lumbar puncture
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Breathing Exercises for Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Despite the advances in pharmacological therapy for asthma, there has been an increasing
      worldwide interest in alternative therapies for asthma. Treatments and therapies such as
      yoga, acupuncture, homeopathy, hypnosis and Buteyko and other breathing techniques have been
      used as complementary therapies however little evidence exists behind such practices.

      Data from systemic reviews and randomized control trials provide evidence of benefit although
      additional confirmation is still needed. Among the most common techniques are the Buteyko
      breathing exercises that aim to reduce minute ventilation by instruct asthmatics patients to
      breathe shallowly and slowly through the nose. The second common technique is the Pranayama,
      or yoga breathing exercises which emphasizes deep respirations and exhalation prolongation.

      Our goal is to assess the effectiveness of breathing exercises as a complementary therapy for
      asthma.
    


Intervention name(s): Breathing exercise
Intervention type(s): Behavioral
Intervention description(s): Patients will be thought 3 different exercises included yoga pranayama, diaphragmatic breathing and pursed lip breathing. Patients will be asked to repeat these exercises at least twice daily for a one month period. Also patients will be thought 4 different exercises which they could use in the event of an asthma exacerbation. Teaching will be supplemented by a breathing exercise brochure and patients will be asked to demonstrate proper technique at initial visit and at the return visit.
Other intervention name(s): Intervention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adults; age 18-65; physician-diagnosed; persistent asthma
Comparative Study on the Effects of Epidural Dexmedetomidine on Heart Rate Variability During General Anesthesia in Patients Undergoing Gastrectomy
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      The use of epidural dexmedetomidine decreases the anaesthetic requirements and improved
      postoperative pain. Dexmedetomidine is a potent and highly selective a2-adrenoceptor agonist
      and has sympatholytic effect. Power spectral analysis of heart rate variability(HRV) is a
      useful tool to assess cardiac autonomic activity. We investigated whether preemptive epidural
      dexmedetomidine can develop hemodynamic change and it could be identify patients by HRV.
    


Intervention name(s): preemptive dexmedetomidine epidural bolus injection(1.5 mcg/kg); normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Patients in the pre-emptive groups recived a dose of 1.5㎍/kg dexmedetomidine dissolved into normal saline 10cc before the induction of; patients in the control groups received the equivalent volume of normal saline.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: dexmedetomidine; heart rate variability; preemptive epidural; gastrectomy
Comparison of Deep Versus Awake Tracheal Extubation in Adults
Condition: Airway Complication of Anesthesia; Respiratory Complications of Care
Study type: Interventional

Summary: 
      Prospective, randomized, single-blinded controlled study to compare the airway and
      respiratory complications of deep and awake tracheal extubations in adults.
    


Intervention name(s): Extubation
Intervention type(s): Procedure
Intervention description(s): Removal of the endotracheal tube
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Awake Extubation; Deep Extubation
Isokinetic Exercises in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The investigators evaluated the effects of isokinetic muscle strengthening exercises of the
      quadriceps and hamstring on muscle strength, joint position sense, pain, kinesiophobia and
      quality of life in patients with multiple sclerosis.
    

Detailed description: 
      Objective: To evaluate the effects of isokinetic exercises on muscle strength, knee joint
      position sense, pain, kinesiophobia, and quality of life in patients with multiple sclerosis.

      Design: Randomized controlled trial. Setting: Outpatient clinic. Participants: Fifty patients
      with multiple sclerosis. Interventions: Fifty patients who met the inclusion criteria were
      randomized to an isokinetic exercise (n:25) or home exercise programme (n:25). Sequentially
      numbered opaque envelopes were used for randomization.

      Outcome measures: The outcome measures were the peak torque/body mass index of quadriceps and
      hamstring muscles at 60°/s and 180°/s velocities, the hamstring/quadriceps ratios at the same
      velocities, absolute angular errors of the 15°, 45°, and 60° and the mean absolute angular
      error of joint position sense of the less and more affected knees, and the scores of Multiple
      Sclerosis Quality of Life-54, Visual Analogue Scale, and Tampa Scale of Kinesiophobia.
    

Intervention name(s): exercises
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This prospective randomized controlled trial aimed to recruit 50 patients with MS from the physical medicine and rehabilitation clinic of Ankara Training and Research Hospital, Health Sciences University, Ankara, Turkey. Fifty patients who met the inclusion criteria were enrolled in the study. Fifty patients were randomized to two groups: isokinetic exercise (Group 1) (n=25) and home exercise (Group 2) (n=25). Randomization was completed using sequentially numbered, opaque envelopes by the investigator. All patients gave informed consent before the assessment. The outcome measures were assessed initially and at eighth week after the treatment. Group 1 performed isokinetic concentric quadriceps and hamstring strengthening exercises under supervision and Group 2 performed lower extremity muscle strengthening and balance exercises at home.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple sclerosis; isokinetic; exercises; joint position sense; kinesiophobia
Safety, Tolerability, and Efficacy Study of rAvPAL-PEG Administered Daily in Subjects With Phenylketonuria (PKU)
Condition: Phenylketonuria
MeSH terms: Phenylketonurias
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of daily administration of rAvPAL-PEG on
      the reduction of blood Phe concentrations in subjects with PKU.
    

Detailed description: 
      This 16-week multi-center, open-label, Phase 2 study is designed to evaluate the safety,
      tolerability,and efficacy of daily SC injections of rAvPAL-PEG in subjects with PKU. Subjects
      who are naïve to prior treatment with rAvPAL-PEG and who have met the other study eligibility
      criteria will be enrolled at approximately 8 sites in the US and Canada. Up to 6 daily dose
      levels of rAvPAL-PEG are planned and may be assessed during this study (0.06 mg/kg/day, 0.1
      mg/kg/day, 0.2 mg/kg/day;0.4 mg/kg/day, 0.6 mg/kg/day, or 0.8 mg/kg/day). Enrollment will
      begin with the 0.4 mg/kg/day dose level and additional higher or lower doses may be added.
      The additional dose levels chosen for assessment will be based on the safety (systemic
      reaction or clinically significant abnormal laboratory test results assessed as related to
      study drug) and efficacy (blood Phe reduction to less than or equal to 60 μmol/L) information
      of at least 3 subjects with at least 2 weeks of daily dosing with rAvPAL-PEG. Initiation of
      dosing at higher or lower dose levels will be per the determination of the Sponsor's Medical
      Officer in consultation with the Investigator.
    

Intervention name(s): rAvPAL-PEG
Intervention type(s): Drug
Intervention description(s): 0.06 mg/kg/day, 0.1 mg/kg/day, 0.2 mg/kg/day, 0.4 mg/kg/day, 0.6 mg/kg/day, 0.8 mg/kg/day
Other intervention name(s): Recombinant Anabaena variabilis phenylalanine ammonia lyase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PEG PAL; PKU; injection;
Blood Pressure Monitor Clinical Test (Cuff Range: 22 Cm-36cm)
Condition: Blood Pressure
Study type: Observational

Summary: 
      The purpose of this study is to monitor the blood pressure level of the patient using a
      preformed cuff ranged 22 cm-36 cm.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        resident of a community
      
Keywords: BP
Dose Escalation Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      A one month multi-dose study will evaluate the safety and tolerability of 3 intravenous
      infusions of RSLV-132 in subjects with inactive to mild SLE.
    


Intervention name(s): RSLV-132
Intervention type(s): Biological
Intervention description(s): 0.3 - 10.0 mg/kg RSLV-132 weekly for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: RSLV-132; Systemic Lupus Erythematosus; Lupus; SLE; Resolve
Robotics Plus VR in Improving Cognition
Condition: Cognition Disorders
MeSH terms: Cognition Disorders
Study type: Interventional

Summary: 
      Stroke can be classified as ischemic, i.e. due to the lack of blood flow, and haemorrhagic,
      caused by bleeding. Stroke results in focal signs and symptoms, with a devastating impact on
      a patient and his family. Although robotic rehabilitation is very useful in improving motor
      function, there is no a clear evidence on its role in improving cognitive abilities, which
      are often compromised in stroke patients.

      To this end, the investigators designed a randomized controlled experimental study on stroke
      patients, with the aim of evaluating the effects of robotic neurorehabilitation using Lokomat
      with and without virtual reality on cognitive functioning in stroke patients, compared to
      traditional therapy.
    


Intervention name(s): Robotic Treatment plus VR
Intervention type(s): Device
Intervention description(s): The patients included will be divided into three groups of 30 patients each. In this group patients will undergo a rehabilitation training with the Lokomat-Pro, in which the exoskeleton device is equipped with a screen with virtual reality. The rehabilitation protocol consists of 24 training sessions (3 sessions per week, for 8 weeks, each session lasting about 45 minutes). The Lokomat-Pro will be used to improve gait, whereas motor and cognitive function will be normally trained by using conventional neurorehabilitation. Patients will be evaluated at baseline (T0), immediately (T1) and after 3.month (T2) of treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lokomat; Robotic rehab; Executive function; VR
Perioperative Endothelial Dysfunction
Condition: Myocardial Injury
Study type: Observational

Summary: 
      More than one in 100 otherwise healthy patients undergoing non-cardiac surgery will die
      within 30 days post-operatively, and of these patients 45% will die from vascular causes such
      as myocardial infarction. The pathogenesis of perioperative myocardial infarction is complex
      and to date not fully elucidated. The physiological stress response associated with the
      surgical procedure is believed to be central in the development of perioperative
      cardiovascular complications. Surgery initiates systemic inflammation, hypercoagulability and
      increases the production of catecholamines and cortisol. These drastic systemic changes lead
      to a state of myocardial oxygen supply-demand mismatch, which added to acute endothelial
      dysfunction and ruptures of vulnerable plaques, may result in myocardial injury.

      The endothelium is a regulator of vascular homeostasis, vascular tone and structure and
      exerts anticoagulant, antiplatelet and fibrinolytic properties. Endothelial dysfunction is
      characterized by a decreased vascular bioavailability of nitric oxide probably due to an
      increased degradation of nitric oxide via its interaction with locally produced reactive
      oxygen species. No clinical studies have investigated whether peri- and postoperative
      endothelial dysfunction is associated with an increased risk of perioperative myocardial
      injury. Endothelial dysfunction may be a key element in the development of perioperative
      myocardial injury.

      The aim of this observational clinical study is to closely examine the endothelial function
      and its dynamics in the early postoperative period.
    


Intervention name(s): Elective colon cancer surgery
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A population of patients with colon cancer undergoing elective cancer surgery.
      
Biospecimen description: 
      Plasma
    
Keywords: Endothelial dysfunction; General Surgery; Perioperative Care