bioihbjkbjnl/mcl2 huggingface dataset:
GSK1358820 (Botulinum Toxin A) PhIII DB & OL Study in Patients With Axillary Hyperhidrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to demonstrate superiority of single treatment of
      GSK1358820 (hereinafter, referred to as BOTOX®) over placebo in terms of the efficacy of
      treatment with BOTOX® 50 U in each axilla (100 U in total for each patient) as intradermal
      injections based on gravimetric assessment (measurement of spontaneous axillary sweat
      production) for axillary hyperhidrosis.
    


Intervention name(s): GSK1358820; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Onabotulinum toxin type A; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Neuromuscular Agents; Botulinum Toxin Type A; Sweating; Sweat Gland Disease; Axillary Hyperhidrosis; Skin Disease
Intrauterine Balloon Tamponade in the Management of Postpartum Hemorrhage
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      Intrauterine balloon tamponade in the management of postpartum hemorrhage in the obstetrics
      emergency ward in menoufiya university hospitals as a low resource setting.Guidelines for the
      management of postpartum hemorrhage involve a stepwise approach including the exclusion of
      retained products and genital tract trauma. Uterine atony, which is the most common cause, is
      dealt with uterine rubbing and various uterotonic agents. Among the new modalities introduced
      to arrest the bleeding is the uterine tamponade using various balloons and catheters. The
      condom catheter uses a sterile rubber catheter fitted with a condom for uterine tamponade .
    

Detailed description: 
      Objectives: To evaluate the outcome of uterine balloon tamponade using condom-catheter in the
      management of primary postpartum hemorrhage (PPH).

      Material and Methods: Prospective observational study included 50 women with primary
      postpartum hemorrhage unresponsive to uterotonics and bimanual compression, was conducted at
      the department of Obstetrics &Gynecology, Menoufia University Hospital, Egypt. Clinical
      assessment, laboratory investigations and intrauterine condom catheter were applied to all
      patients. The primary outcome was the success of the balloon to stop bleeding, maternal
      complications were assessed as secondary outcomes.
    

Intervention name(s): condom balloon catheter
Intervention type(s): Device
Intervention description(s): The condom balloon catheters were inserted into the uterine cavity digitally or with forceps .Tight vaginal pack was inserted or cervical stitch was done to prevent displacement of the balloon catheter.
(2)-Insertion at Cesarean Section: The catheter was inserted through the uterine incision (pushing the tip to the fundus and the drainage port through the cervix into the vagina) or transvaginally and inﬂated after the uterine incision was closed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Postpartum Hemorrhage; Uterine Tamponade; Condom Catheter
Aquatic Therapy Versus Land-Based Therapy for the Treatment of Balance Dysfunction in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The aim of this study is to compare the effectiveness of a specific aquatic therapy program
      on balance with a land-based physical-treatment in patients with Parkinson's disease and to
      evaluate the long-term effects in a 6-month follow-up period.
    

Detailed description: 
      Background: Balance dysfunction (BD) in Parkinson's disease (PD) is a disabling sign leading
      to falls which have a negative impact on the quality of life. It is known that aquatic
      therapy could be useful to train balance given its physical features and for reducing
      patients' fear of falls. Many studies have evaluated the efficacy of land-based physiotherapy
      in treatment of BD, but few studies have investigated the efficacy of aquatic therapy on
      balance and none of those assessed clinical measurements in a clinically, relevant follow-up
      period.

      Objective: The aim of study was to compare the effectiveness of a specific aquatic therapy
      program on balance with a land-based physical-treatment in patients with PD and to evaluate
      the long-term effects in a 6-month follow-up period.

      Methods: Thirty-four patients with PD in medium-stage of disease were randomized into two
      groups: 17 underwent Multidisciplinary-Intensive-Rehabilitation-Treatment (MIRT) and 17
      underwent MIRT associated with aquatic therapy protocol (MIRT-AT). Investigators assessed the
      Berg Balance Scale (BBS), Unified Parkinson's Disease Rating Scale (UPDRS) II-III, and Timed
      Up Go test (TUG) in both groups at admission, discharge and after a 6-months follow-up
      period.
    

Intervention name(s): MIRT-AT; MIRT
Intervention type(s): Other; Other
Intervention description(s): Aquatic therapy; Land-based Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Parkinson's disease, aquatic therapy, balance, MIRT
Influence of Initial Levothyroxine Dose on Neurodevelopmental and Growth Outcomes in Congenital Hypothyroidism
Condition: Congenital Hypothyroidism
MeSH terms: Congenital Hypothyroidism; Hypothyroidism
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to evaluate the risk-benefit profile of long-term
      treatment of two different initials treatment schemes with L-T4 on the neurodevelopmental and
      auxological outcomes in children with congenital hypothyroidism, diagnosed by neonatal
      screening in order to find the best dose of initial thyroid hormone replacement to assure the
      best long-term developmental outcome without any adverse effects on auxological,
      cardiovascular and skeletal outcomes. The secondary objective of the study is to evaluate the
      role of other factors that, in addition to the initial L-T4 therapy,can influence long-term
      neurodevelopmental and auxological outcomes as well as the cardiovascular system and bone
      metabolism outcomes.
    

Detailed description: 
      Seventy-two neonates detected by the neonatal screening program for congenital hypothyroidism
      were randomly assigned to receive one of the two initial L-T4 replacement dose: Group A
      received an initial replacement dose of 10-12.5 mcg/kg/die and Group B received an initial
      replacement dose of 12.6-15 mcg/kg/die. The adequacy of treatment were monitored closely by
      clinical evaluation and regular measurement of FT4 and TSH. Cognitive development were
      evaluated through the Griffiths Mental Development Scales at the the age of 2 yeas. Cognitive
      and behavioural assessment at the age of 4 years were performed using the Wechsler Preschool
      and Primary scale of Intelligence. Growth were evaluate at the enrolment and at each visit.
      Skeletal maturation were evaluated at diagnosis and at the age of 1 and 4 years. At the age
      of 4 years a quantitative ultrasound measurements and cardiovascular evaluation were
      performed.
    

Intervention name(s): Levothyroxin
Intervention type(s): Drug
Intervention description(s): Congenital hypothyroidism children received two different doses of levothyroxin within the recommended range to evaluate any differences in long-term outcomes.
Other intervention name(s): L-T4
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Children were randomly assigned to receive an initial L-T4 dose of 10-12.5 μg/kg/day (Group A) or 12.6-15 μg/kg/day (Group B). Randomization was designed according to a block scheme (8 blocks of 6 patients and 6 blocks of 4 patients which were randomly alternated) which guaranteed the frequency balance in the two groups during the enrolment without altering the causality of the assignment. Random allocation sequence was generated using the function sample in R statistical platform.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neonatal screening; Levothyroxine treatment; Neurocognitive; Growth
Serratus Plane Block For Breast Reduction Surgery
Condition: Pain Management
Study type: Interventional
Phase: Phase 4

Summary: 
      Serratus plane block was first described in 2013 by Blanco and designed to primarily block
      the thoracic intercostal nerves. And this block provides sufficient analgesia lateral
      anterior and posterior part of thoracic wall.Increased use of ultrasound guidance for
      regional anesthesia in recent years has led to definition of thoracic wall PECs blocks by
      Blanco. The Serratus plain block (SPB), providing wider analgesia, with easier application
      and less adverse effects than neuroaxial blocks, has been defined after these blocks and has
      taken its place in the literature.In spite of the insufficient randomized clinical trials in
      the literature, SPB has been reported for many cases such as thoracoscopy, shoulder
      arthroscopy, breast surgery and axillary lymph node dissections, and the results are
      promising. The aim of this study is to determine effectiveness of ultrasound guided bilateral
      serratus plane block in patients undergoing breast reduction surgery.

      Main outcome measures: The primary endpoint is postoperative opioid consumption.

      Secondary endpoints are visual analogue pain scores, opioid related side effects.
    


Intervention name(s): Bupivacaine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): 30 ml %0,25 bupivacaine bilaterally; 2 ml saline subcutaneously bilaterally
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative Analgesia; Ultrasound guided serratus plane block
A Safety Study Evaluating N6022 in Multiple-Ascending Doses in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study will evaluate multiple doses across a range that has been found to be
      effective in mouse models of asthma and safe in one Phase 1 clinical trial. It is intended to
      provide evidence of the tolerability of multiple doses as well as provide information on the
      Pharmacokinetic (PK) and metabolism of N6022 in humans.
    

Detailed description: 
      This is a double-blind, randomized, placebo-controlled, multiple ascending dose study, in at
      least three ascending cohorts. Twenty-four subjects will be enrolled initially in the first
      three cohorts, with up to 40 subjects to be enrolled overall if additional cohorts are
      required to reach the maximum tolerated dose (MTD). The cohorts will be enrolled in two
      groups of 4 each with approximately 7 days between groups to conduct safety monitoring
      committee review for approval to proceed to the second group in the cohort. Eight subjects
      will be enrolled per cohort, randomized 3:1 to N6022: placebo. Each subject will undergo
      screening (Day -28 to Day -2) and, if eligible, they will be instructed to begin a
      low-nitrate diet on Day -4. Subjects will return to the clinical site on Day -1, and
      eligibility will be reconfirmed. Eligible subjects will receive a dose of investigational
      medicinal product ([IMP], N6022 or placebo) by intravenous (IV) infusion on study Days 1
      through 7 and will be followed for safety, PK, and PD until discharge on the morning of Day
      8. Subjects will return to the clinic for a follow-up visit on Day 15 (± 1 day) and will be
      contacted via telephone on Day 28 (± 1 day) for the end-of-study safety follow-up visit.
      Participation of an individual subject may last approximately 56 days from the time of
      screening until the end-of-study follow-up visit.

      A Safety Monitoring Committee (SMC) will review the safety data in each cohort after the Day
      15 Follow-up visit, before proceeding to the next ascending dose cohort, modifying the dose,
      repeating a dose, or stopping the study according to the stopping rules outlined in the
      protocol.
    

Intervention name(s): 5 mg/N6022; Placebo; 10mg/N6022; 20mg/N6022
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Intravenous formulation, given at doses of 5 mg once each day over 7 days.; Same administration procedures as active; Intravenous formulation given at doses of 10 mg once each day over 7 days.; Intravenous formulation given at doses of 20 mg once each day over 7 days.
Other intervention name(s): N6022; GSNOR Inhibitor; Normal Saline; N6022; GSNOR Inhibitor; N6022; GSNOR Inhibitor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: N6022, GSNORi
Two-year Follow-up to High-intensity Multi-component Agility Intervention That Improves Clinical and Motor Symptoms of Parkinson's Disease
Condition: Follow up; Parkinson Disease; Rehabilitation
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Individualization of exercise is recommended but rarely performed in patients with
      Parkinson's disease (PD).

      Unusually High Intensity and Individual Sensor Motor with Visuomotor Mobility Trainer The
      clinical symptoms, mobility and posture of PD patients. After 3 weeks of intensive treatment,
      treated patients and the control group were subjected to a two-year observation.

      Objectives: The effect of the unusually highly intense and strictly individualized sensomotor
      and visuomotor agility program was determined for the clinical symptoms, mobility and
      stability of non-demented PD patients with a two-year follow-up. Detection and comparison of
      results of patients undergoing biphasic maintenance with the results of intensively treated
      patients and the control group.

      Patients were recalled every 3 months after the first intensive examination and one year
      after a one-year control. The results of the active group were continuously compared with the
      results of the passive and control groups, thus determining the effectiveness of our
      treatment and the deterioration of the other groups in life-quality.

      The treated groups will be divided into two. One Parkinson's group takes part in a treadmill
      treatment that takes place 3 times a week for 2 years. The other group does not undergo a
      special series of exercises after 3 weeks of intensive therapy.

      Main outcome measures: Movement disorder Society Unified Parkinson Disease Rating Scale,
      Motor Experiences of Daily Living, a measure sensitive to changes in a broad spectrum of PD
      symptoms.

      In group time, repeated measurements of variance analysis were compared to MDS-UPDRS M-EDL,
      Beck Depression Score, PDQ-39, EQ5D VAS, Schwab & England Scale for Parkinson's Disease. The
      TUG test and 12 static posturographic measurements are compared and compared to the healthy
      group as a standard.

      An at-limit and individualized sensorimotor and visuomotor agility exercise program vs.
      standard care, will improve non-demeted, stage 2-3 PD patient's clinical symptoms, mobility,
      and postural stability by functionally meaningful margins. As a long-term solution, a
      follow-up treatment can slow down the progression of clinical symtoms.
    


Intervention name(s): Follow-up; Post-treatment control; Control Parkinson group
Intervention type(s): Other; Other; Other
Intervention description(s): After 3 weeks of intensive treatment, no special exercises are performed as a control.; No treatment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Balance; Posturograpy; quality of life
Procalcitonin in Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      the value of serum procalcitonin in differentiation between bacterial infection and non
      infectious inflammation in febrile HCC patients following locoeregional treatment for HCC.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        inpatients in tropical medicine department and hepatocellular carcinoma out patient clinic
        ain shams university
      
Biospecimen description: 
      Serum
    
Keywords: hepatocellular carcinom; postablation syndrom; procalcitonin
Bioavailability Study of Oral OZ439 Prototype Formulations Administered With Piperaquine Phosphate (PQP)
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      A single dose study to investigate how different formulations of OZ439 co-administered with
      PQP tablest are processed by the body when taken without food
    


Intervention name(s): 800mg OZ439 prototype formulation 1; 800mg OZ439 prototype formulation 2; 800mg OZ439 prototype formulation 3; 960mg PQP
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Treatment A; Treatment B; Treatment C; Piperqauine phosphate as powder in bottle
Intervention MeSH terms: Artefenomel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malaria; Bio-availability
Adefovir Dipivoxil For The Treatment Of Chinese Compensated Chronic Hepatitis B(CHB)Patients
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      This 48-week open-label study of local manufactured adefovir dipivoxil Tablet evaluates the
      efficacy and safety of adefovir 10mg once daily in Chinese subjects with compensated CHB.
      Primary endpoint is proportion of subjects achieving HBV DNA undetectable (<=1000 copies/mL
      by by Roche COBAS AMPLICOR HBV MONITOR Test) at week 48. Approximately 1250 patients will be
      recruited in 30 study centers in China. The subjects are offered 48 weeks of open label
      adefovir dipivoxil treatment, with assessments every three months, after with is a 12-week
      post study treatment follow-up prior to study completion.
    


Intervention name(s): adefovir dipivoxil
Intervention type(s): Drug
Intervention description(s): adefovir dipivoxil once daily one tablet 10mg orally
Intervention MeSH terms: Adefovir; Adefovir dipivoxil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adefovir dipivoxil; compensated; chronic hepatitis B; Chinese
Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (The EXACT Trial)
Condition: Coronary Artery Disease; Ischemia; Angina Refractory; Cardiovascular Diseases; Heart Diseases
MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Angina Pectoris; Ischemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary purpose of this trial is to determine the safety of XC001 (AdVEGFXC1) in patients
      who suffer from angina caused by coronary artery disease and have no other treatment options.
      Subjects in this study will receive one of four intramyocardial doses of XC001 that expresses
      human vascular endothelial growth factor (VEGF) which induces therapeutic angiogenesis
      (revascularization).
    

Detailed description: 
      This is a Phase 1/2, first-in-human, multicenter, open-label, single arm dose escalation
      trial of XC001. Approximately 12 subjects (N=3 per cohort) who have refractory angina will be
      enrolled into 4 ascending dose groups, followed by an expansion of the highest tolerated dose
      with 32 additional subjects. XC001 will be administered by a transthoracic epicardial
      procedure. Safety will be the focus for the initial 6 months after XC001 administration
      followed by one safety focused telephone evaluation at Month 12.
    

Intervention name(s): AdVEGFXC1
Intervention type(s): Biological
Intervention description(s): AdVEGFXC1 at one of 4 doses
Other intervention name(s): XC001
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Refractory angina; Coronary Artery Disease; Gene Therapy
Oral Manifestation in Patients With SARS-CoV2 Infection.
Condition: SARS-CoV Infection
MeSH terms: Infections; Communicable Diseases; COVID-19; Severe Acute Respiratory Syndrome; Oral Manifestations
Study type: Observational

Summary: 
      The oral cavity is particularly susceptible to viral infection with several viruses such as
      herpes simplex virus, cytomegalovirus and Zika virus because of its structures, especially
      salivary glands and soft tissues Moreover, oral mucosa can be affected by secondary
      pathological process of a bacterial or fungal nature due to viral immunosuppression. The oral
      cavity could be considered a "biological barometer" of both viral infection and viral
      immunosuppression advancement .
    

Detailed description: 
      The SARS-Cov2 virus was identified in china at the end of 2019 and spread worldwide causing a
      global pandemic. Current research showed that SARS-Cov2 virus invades human cells via the
      receptor angiotensin-converting enzyme 2 (ACE2) through scRNA-seq data analyses. The study
      identified the organs that are at risk and are vulnerable to SARS-CoV-2 infection. Therefore,
      cells with ACE2 receptor distribution may become host cells for the virus and cause
      inflammatory response in related organs and tissues, such as the tongue mucosa and salivary
      glands. These results suggest that oral mucosa could be a target of SARS-CoV-2 infection .

      Although many authors reported the presence of oral lesion associated with SARS-CoV2
      infection, the prevalence of the oral manifestation and the range of oral manifestation are
      still unknown. Further studies are necessary to better understanding of the symptoms of the
      SARS-CoV2 virus in order to faster detection. A multidisciplinary team following the patients
      could be the key in treatment of the infection and faster recovery.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients with SARS-CoV2 infection confirmed with PCR will be recruited form 3 different
        isolation hospitals at Ministry of health and population. Patient selection will be based
        on certain inclusion and exclusion criteria.
      
Keywords: oral Manifestation; SARS-CoV2; prevelance