bioihbjkbjnl/mcl2 huggingface dataset:
Ultrasound-guided Sciatic Nerve Block in Below Knee Amputation Surgery
Condition: Sciatic Nerve Block
Study type: Interventional

Summary: 
      56 ASA physical status II and III patients, aged 45-75 year, undergoing elective below knee
      amputation were randomly assigned to receive either sciatic nerve block using a popliteal
      approach or a sub gluteal approach. Patients in both groups received same amount of LA and
      additional ultrasound guided femoral nerve block to ensure sensory block of the medial side
      of the leg. Success of the block was considered when the block is solid and doesn't require
      shifting to GA
    

Detailed description: 
      56 ASA physical status II and III patients, aged 45-75 year, undergoing elective below knee
      amputation were randomly assigned to receive either sciatic nerve block using a popliteal
      approach (group P, n 28) or a sub gluteal approach (group G, n 28). Patients in both groups
      received same amount of LA (25 ml of bupivacaine 0.5 %) and additional ultrasound guided
      femoral nerve block by 10 ml of bupivacaine 0.5% to ensure sensory block of the medial side
      of the leg. Time to complete sensory and motor block, time taken to perform the block,
      block-related complications, block duration, time for asking for rescue analgesia in the
      first 24 h were recorded and both patients and surgeons were asked about their level of
      satisfaction. Success of the block was considered when the block is solid and doesn't require
      shifting to GA
    

Intervention name(s): sciatic nerve block
Intervention type(s): Procedure
Intervention description(s): blocking sciatic nerve either at the subgluteal area or the popliteal region for effective anesthesia and analgesia during below knee amputation
Other intervention name(s): sciatic nerve block at the subgluteal and popliteal region
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Health Services Research
Turkish Version of the Ankle Instability Instrument
Condition: Ankle Injuries
MeSH terms: Ankle Injuries
Study type: Observational

Summary: 
      This study aimed to translate the Ankle Instability Instrument into Turkish language, to
      perform a cultural adaptation study and to evaluate its validity and reliability in the
      Turkish population. Ankle Instability Instrument was developed to determine the ankle
      instability level of individuals with a history of ankle injury. Assessment of ankle
      instability is particularly useful in determining the complaints and functional levels of
      individuals with a history of functional or chronic ankle instability. It is anticipated that
      introducing this scale to our language will contribute to other studies in this field.
    


Intervention name(s): Determining the level of ankle instability
Intervention type(s): Behavioral
Intervention description(s): Ankle instability
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with a history of ankle injury and healthy population.
Dexmedetomidine Infusion During Laparoscopic Adrenalectomy
Condition: Pheochromocytoma
MeSH terms: Pheochromocytoma
Study type: Interventional

Summary: 
      The investigators planned this study to investigate the effects of dexmedetomidine
      administration on intraoperative hemodynamic stability in patients with pheochromocytoma.
    


Intervention name(s): dexmedetomidine; 0.9% normal saline
Intervention type(s): Drug; Drug
Intervention description(s): In the dexmedetomidine group, dexmedetomidine is administered at a rate of 0.5 μg/kg/h immediately after anesthesia induction and continued until the completion of the surgery. The research nurse, who did not participate in the study other than the management and preparation of the study medication, prepared 50mL of 0.9% normal saline for the control group and a mixture of dexmedetomidine 2 mL and 0.9% normal saline 48 mL (at a concentration of 4 μg/mL) for the dexmedetomidine group.; In the control group, a 0.9% normal saline infusion is initiated at the same rate immediately after anesthesia induction and continued until the end of the operation.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Effect of Non-estrogenic Pollen Extract PCC-100 on Hot Flushes
Condition: Breast Cancer; Hot Flashes; Postmenopausal Symptoms
MeSH terms: Breast Neoplasms; Hot Flashes
Study type: Interventional

Summary: 
      Many postmenopausal women have vasomotor symptoms during adjuvant hormonal treatment for
      breast cancer. PCC-100 is a pollen extract used for alleviation of postmenopausal symptoms.
      In a randomised, double blinded study pollen extract PCC-100 will be used to treat vasomotor
      complaints in postmenopausal women under adjuvant hormonal treatment and also in menopausal
      women without a history of breast cancer.
    


Intervention name(s): non-estrogenic pollen extract PCC-100; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): non-estrogenic pollen extract PCC-100; placebo -non-estrogenic pollen extract PCC-100
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety, Pharmacokinetics and Pharmacodynamics of BIBR 1048 MS Capsule in Healthy Male Subjects of Japanese and Caucasian Origin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate and compare safety, pharmacokinetics and pharmacodynamics of BIBR 1048
      MS following oral administration of single (150 mg, 220 mg and 300 mg) and multiple (150 mg
      and 220 mg q.d. and 150 mg b.i.d.) rising doses in healthy male subjects of Japanese and
      Caucasian origin.
    


Intervention name(s): BIBR 1048 MS low dose; BIBR 1048 MS medium dose; BIBR 1048 MS high dose
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Dabigatran
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial for Localised High-risk Rhabdomyosarcoma and Rhabdomyosarcoma-like Soft Tissue Sarcoma
Condition: Soft Tissue Sarcoma
MeSH terms: Sarcoma; Rhabdomyosarcoma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate whether the addition of oral maintenance
      chemotherapy with O-TIE (Etoposide, Idarubicin, Trofosfamide) for 6 months improves the event
      free survival (EFS) in patients with localised high-risk RMS and RMS-like Soft Tissue
      Sarcoma.
    


Intervention name(s): trofosfamide, idarubicin, etoposide
Intervention type(s): Drug
Intervention description(s): oral maintenance therapy for 6 months
Intervention MeSH terms: Etoposide; Idarubicin; Trofosfamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric soft tissue sarcoma; rhabdomyosarcoma; extraosseous Ewing family tumours; synovial sarcoma; undifferentiated sarcoma
IMS-treatment and Canalis Carpi Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Carpal tunnel syndrome is a condition in which the median nerve is compressed at the wrist,
      leading to paresthesias, numbness and muscle weakness in the hand. Treatment of the condition
      often involves surgery.

      In this study we wish to se if there is an effect of using intramuscular stimulation (IMS) to
      release the tension of nervus medianus in the lower arm. The study will be performed by
      randomization to IMS of musculus pronator teres or a control ("Scam IMS treatment" to the
      acupuncture point Li11). The two insertion points are approximately 1cm apart in the lower
      arm.
    

Detailed description: 
      The most important outcome measure is ultra sound measured diameters for nervus medianus in
      the carpal tunnel
    

Intervention name(s): Needle in acupuncture point Li11; IMS of the musculus pronator teres
Intervention type(s): Device; Device
Intervention description(s): Acupuncture needle in acupuncture point Li11; Acupuncture needle in musculus pronator teres
Other intervention name(s): Needles; Needles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Safety and Immunogenicity Study of AdCLD-CoV19: A COVID-19 Preventive Vaccine in Healthy Volunteers
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Phase 1/2a clinical trial to assess the safety and immunogenicity of AdCLD-CoV19 in
      healthy adults.
    

Detailed description: 
      Part A is conducted as dose-escalation, single-center, open-label, a Phase 1 clinical trial.
      Part B is conducted as multi-center, open-label, a Phase 2a clinical trial. In Part A, we
      assess safety in all dose groups and set suitable two doses for Part B. In Part B, we assess
      immune responses against SARS-CoV-2 and set suitable dose for next phase of clinical trial.
      DSMB will evaluate safety during the whole study period.
    

Intervention name(s): AdCLD-CoV19
Intervention type(s): Biological
Intervention description(s): Replication-defective human adenovirus type 5/35 vector based vaccine expressing S protein of SARS-CoV-2.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Pilot PK/PD Study of DS-1093a in Patients With Chronic Kidney Disease
Condition: Chronic Renal Disease; Renal Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      DS-1093a is an inhibitor of hypoxia-inducible factor prolyl hydroxylases, and is expected to
      produce transient dose / exposure dependent increases in erythropoietin levels in subjects
      with chronic kidney disease (CKD). This study will be conducted in 2 parts. Part A will
      involve subjects with stage 3b or 4 CKD, and will be an open, non-controlled parallel group
      investigation of three single doses of DS-1093a (6 subjects/dose), in which allocation to
      dose will be randomised. On completion of this part of the study an optional fourth dose may
      be tested to gain a more complete understanding of the PK/PD behaviour of DS-1093a. Part B
      will be an open, non-controlled investigation of a single dose of DS-1093a in CKD subjects
      (n=6) receiving haemodialysis. The dose for Part B will be determined based on the data from
      Part A.
    


Intervention name(s): DS-1093a
Intervention type(s): Drug
Intervention description(s): DS-1093a, single oral doses up to 50 mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hypoxia inducible factor prolyl hydroxylase inhibitor.; Erythropoietin stimulating agent; Chronic renal disease; renal anemia
Biopsies and Polyps
Condition: Nasal Polyps; Asthma
MeSH terms: Asthma; Nasal Polyps; Polyps
Study type: Observational

Summary: 
      Background: Nasal polyps are found in about 5% of asthmatic patients.A close link exists
      between the upper and lower airways and the concept of the "United Airways" has emerged
      mainly from studies on allergic rhinitis and asthma. However, other upper airway diseases,
      such as chronic sinusitis and nasal polyposis may influence lower airway diseases. As for
      nasal polyposis, eosinophils are the major effector cells in asthma and have been associated
      with a worsening of this condition.

      Aim: To compare normal nasal mucosa and nasal polyp biopsies from subjects with nasal
      polyposis with or without asthma.

      Hypothesis: Nasal polyps from asthmatic subjects show a more aggressive pro-inflammatory
      pattern of cytokine expression compared to nasal polyps from non asthmatic subjects, and
      therefore contribute to the development and severity of asthma.
    

Detailed description: 
      The study will include 2 visits separated by a maximum of 7 days. During the first visit,
      subjects' characteristics will be documented by a locally validated questionnaire. Allergy
      skin prick tests, spirometry, methacholine inhalation test and induced sputum will also be
      done. Asthma and rhinitis control will be evaluated by locally validated questionnaires, the
      Asthma Control Scoring System (ACSS) and the Rhinitis Control Scoring System (RCSS),
      respectively. Nasal peak inspiratory flow (NPIF) and oral peak expiratory flow (PEF) will
      also be recorded to obtain the nasal blockage index (NBI). On the second visit, nasal
      biopsies will be taken.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Recruited from the ENT clinic (Laval Hospital, Quebec City, Canada)
      
Biospecimen description: 
      Nasal polyps (Biopsies) Normal nasal mucosa (Biopsies) Sputum
24-hr IOP With Travoprost/Timolol Compared With Latanoprost/Timolol in XFG
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 4

Summary: 
      A crossover, randomized, single-masked study which compares the short-term (3 months) 24-hour
      IOP control and safety of travoprost/timolol fixed combination given once in the evening,
      versus that of latanoprost/timolol fixed combination given once in the evening in patients
      with exfoliative glaucoma. The primary objective of this trial is to compare the quality of
      24-hour IOP control after 3 months of chronic therapy with these two medications.
    


Intervention name(s): treatment with latanoprost/timolol fixed combination; latanoprost/timolol fixed combination drops
Intervention type(s): Drug; Drug
Intervention description(s): dosing in the evening with the two fixed combinations; once in the evening
Intervention MeSH terms: Timolol; Latanoprost
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: 24-hour IOP; exfoliative glaucoma; travoprost/timolol; latanoprost/timolol; fixed combinations
Individualized Precise Localization of rTMS on Primary Motor Area
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Parkinson's disease (PD) patients have some problem with self-initiated movement task.
      Compared with health controls, task meta-analysis found that PD patients showed abnormal
      activation in pre-supplementary motor area (pre-SMA) and putamen. And the functional
      connectivity has already been reported between pre-SMA and putamen in 2013. Repetitive
      Transcranial Magnetic Stimulation (rTMS) is a sage and painless technique to activate
      cortical areas. The deep brain structure can be activated via stimulating superficial cortex
      by rTMS. For investigating the mechanism of self-initiated movement, this project is using
      functional magnetic resonance imaging (fMRI) to individualize the precise localization in
      motor area and combining rTMS to activate putamen.
    

Detailed description: 
      Healthy subject is recruiting in this project. High and low frequency rTMS will be performed,
      respectively. For the l-Hz sessions (low frequency), stimulation is delivered at 100% of the
      subject's resting motor threshold at 1 Hz continuously over 30 min for a total of 1,800
      pluses. The 10-Hz stimulation is delivered at 100% of the subject's resting motor threshold
      via 60 trains of 3-s 10-Hz rTMS (30 pulses per train).
    

Intervention name(s): rTMS
Intervention type(s): Device
Intervention description(s): For the l-Hz sessions (low frequency), stimulation is delivered at 100% of the subject's resting motor threshold at 1 Hz continuously over 30 min for a total of 1,800 pluses. The 10-Hz stimulation (high frequency) is delivered at 100% of the subject's resting motor threshold via 60 trains of 3-s 10-Hz rTMS (30 pulses per train).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: fMRI; rTMS; functional connectivity
Reducing Fear of Childbirth Among Pregnant Women
Condition: Fear of Childbirth
Study type: Interventional

Summary: 
      Pregnant women often experience fear of childbirth or anxiety toward the labor pain or
      uncertainties associated with labor process. To develop and evaluate the efficacy of
      childbirth educational interventions on reduction of fear or anxiety is an important issue in
      maternal health care.
    

Detailed description: 
      Fear of childbirth is a common clinical problem among perinatal women and link to adverse
      health effects on mother's and offspring's well-being. Recently, reducing the childbirth fear
      becomes a highly important maternity care issues as a result of the fact that the birth rate
      has been declining rapidly as well as Cesarean rate increased steadily. However, the studies
      on fear of childbirth among perinatal population in Taiwan were limited. In this proposal the
      investigators plan to conduct a randomized controlled study examining the effects of
      mindfulness-based childbirth education. In the randomized controlled study, women will be
      recruited and randomized into the experiment group (receiving mindfulness-based childbirth
      education and traditional childbirth education),or will be allocated in the control group
      receiving traditional childbirth education. Intention-to-treat analysis as well as mixed
      regression modeling will be used to estimate the effectiveness of the interventions.
    

Intervention name(s): Mindfulness-Based Childbirth Education
Intervention type(s): Behavioral
Intervention description(s): 8-week mindfulness-based childbirth education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: fear of childbirth, pregnancy, childbirth education,
Median Study for Biochemical Serum Markers in First Trimester of Pregnancy
Condition: Pregnancy
Study type: Observational

Summary: 
      The purpose of this study is to get initial values (normal medians) for certain biochemical
      serum markers for pregnancy weeks 10-13. Also initial values for mean arterial blood pressure
      measurement and certain ultrasound measurement may be established.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        women in first trimester of pregnancy coming to antenatal assessment
      
Biospecimen description: 
      Serum
The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains (IPV)
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Based on pre-clinical trial and phase 1 clinical data and principle of GCP, the objective of
      phase Ⅱ clinical trial is to evaluate safety and immunogenicity of Inactivated Poliomyelitis
      Vaccine made from Sabin Strains(Sabin IPV).
    

Detailed description: 
      The Sabin IPV was manufactured with poliovirus type1, 2, 3 Sabin strains and Vero cells by
      microcarrier culture in 550 liter bioreactors. The virus suspension was harvested
      ,ultra-concentrated, purified and inactivated with formalin. Three formulations A,B,C of
      Sabin IPV were used, the DAg contents for A were type1 45,type2 64,type3 67.5 DU /0.5ml/per
      dose; for B 30,32,45 DU/0.5ml/per dose; for C 15,16,22.5 DU/0.5ml/per dose.

      Oral Poliomyelitis Vaccine(OPV)was manufactured by Institute of Medical Biology, Chinese
      Academy of Medical Sciences.Trivalent OPV contains Polioviruses Type 1 6.0 log CCID Type 2
      5.0 log Type 3 5.5log /0.1ml/per dose Inactivated Poliomyelitis Vaccine (Salk strains)was
      manufactured by Sanofi Pasteur DAg contents /0.5ml/per dose were Type 1 40 DU,Type 2 8DU,Type
      3 32DU.

      This is a randomized, blind phase 2 clinical trial. Total 500 infants (ages 60 days to 90
      days) were selected , randomized to five groups(each group n=100) Sabin IPV formulations
      A,B,C,OPV ,Salk IPV were separately given to each group with three doses one month apart
      respectively.
    

Intervention name(s): Inactivated Poliomyelitis Vaccine (Sabin strains); Inactivated Poliomyelitis Vaccine (Sabin strains); Inactivated Poliomyelitis Vaccine (Sabin strains); Oral Poliomyelitis Vaccine; Inactivated Poliomyelitis Vaccine (Salk strains).
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Inactivated Poliomyelitis Vaccine (Sabin strains) formulation A. 3x0.5ml intramuscular injections,one month apart.; Inactivated Poliomyelitis Vaccine (Sabin strains) formulation B. 3x0.5ml intramuscular injections, one month apart.; Inactivated Poliomyelitis Vaccine (Sabin strains) formulation C. 3x0.5ml intramuscular injections, one month apart.; Oral Poliomyelitis Vaccine (OPV).3x0.5mloral, one month apart.; 3x0.5ml intramuscular injections, one month apart.
Other intervention name(s): Sabin IPV; Sabin IPV; Sabin IPV; OPV; Salk IPV
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Inactivated Poliomyelitis Vaccine; Sabin Strains; poliomyelitis
Safety of Thoracoscopy in Patients With High Risk
Condition: Pleural Diseases
MeSH terms: Pleural Diseases
Study type: Observational

Summary: 
      Medical thoracoscopy can be performed for diagnostic as well as therapeutic purposes.
      Thoracoscopy in the diagnosis of pleural diseases is highly sensitive for detecting pleural
      neoplasia with negative pleural fluid cytology and in the diagnosis of tuberculosis. The
      indication of thoracoscopy in patients with pleural effusion has been optimized. In some
      studies medical thoracoscopy has been claimed a useful diagnostic tool with a very low rate
      of complications. However the investigators do not know its safety on high risk patients.
      Because many patients having suspected malignancy have bed conditions due to other health
      problems such as coronary heart diseases, COPD, arrythmia, hypoxemia. In this study the
      investigators aimed to test the safety of medical thoracoscopy in the patients with high risk
      for complications.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who require thoracoscpic investigation
      
Keywords: thoracoscopy; pleural diseases; complications; safety