bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Iloprost on Pulmonary Oxygenation in Patients With Low Diffusing Capacity During One-lung Ventilation
Condition: Lung Cancer
Study type: Interventional

Summary: 
      One lung ventilation (OLV) is essential during thoracic surgery. During OLV, intrapulmonary
      shunt can be increased resulting hypoxemia. Although OLV technique had been advanced so far,
      hypoxemia during OLV reaches about 10% in spite of inspired oxygen fraction 100%. Iloprost is
      a prostaglandin analogue used for pulmonary hypertension, which can decrease pulmonary artery
      resistance by selectively dilating pulmonary artery. In this prospective, randomized, double
      blind study, investigators are planning to investigate the effects of iloprost on respiratory
      physiology (intrapulmonary shunt, deadspace, oxygenation, etc).
    


Intervention name(s): iloprost; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): 20μg(2ml) of inhaled iloprost (Ventavis®)
When anesthesia induction finishes, change patients' position from supine to lateral position and measure arterial blood gas analysis (ABGA), venous blood gas analysis (VBGA) while two lung is ventilated. After 20 minutes of applying one lung ventilation, measure ABGA. Apply iloprost or normal saline inhalation for each iloprost and control group and measure ABGA at the time of 20 min and 40 min after iloprost (or normal saline) inhalation has finished.; 20μg(2ml) of inhaled normal saline
When anesthesia induction finishes, change patients' position from supine to lateral position and measure ABGA, VBGA while two lung is ventilated. After 20 minutes of applying one lung ventilation, measure ABGA. Apply iloprost or normal saline inhalation for each iloprost and control group and measure ABGA at the time of 20 min and 40 min after iloprost (or normal saline) inhalation has finished.
Intervention MeSH terms: Iloprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Suturing Material on Scar Healing
Condition: Wound Heal; Cesarean Section Complications; Cesarean Wound Disruption; Suture Related Complication
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      We want to compare the effects of 2 suture materials (monofilament and multifilament) on
      healing of the uterine scar after a cesarean delivery.
    

Detailed description: 
      Cesarean section (CS) is the most common type of obstetric surgery. When medically justified,
      CS can effectively prevent maternal and perinatal mortality and morbidity however, there are
      many short and long-term complications of CS. One of the most common complications is the CS
      scar defect. CS scar defects can develop after transverse incision of the lower uterine
      segment, which may result in prolonged postmenstrual bleeding, spotting, pelvic pain, and
      infertility. Suture material is an essential part of any major surgery, serving to hold
      opposing tissues together and accelerate the healing process, resulting in decreased scarring
      of the affected areas. We sought to evaluate the effects of different synthetic absorbable
      suture materials on cesarean scar defect formation.
    

Intervention name(s): Monofilament suture; Multifilament suture
Intervention type(s): Other; Other
Intervention description(s): 1.0 monofilament synthetic absorbable suture for closure of the low transverse uterine incision; 1.0 multifilament synthetic absorbable suture for closure of the low transverse uterine incision
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cesarean section; scar heal; isthmocele; suture material; saline infusion sonography
Study to Assess the PK of Ketorolac Tromethamine Intranasal and to Assess the Effects of a Oxymetazoline Hydrochloride on the PK of Ketorolac Tromethamine
Condition: Assess Pharmacokinetics of Ketorolac Tromethamine Intranasal and Assess Effects of a Oxymetazoline Hydrochloride on the PK of Ketorolac Tromethamine
Study type: Interventional
Phase: Phase 1

Summary: 
      This was an open label, two way crossover study in healthy male subjects. Two treatments were
      administered to each subject, one treatment per study period, in a randomized manner.
      Subjects remained resident in the Clinical Unit from the evening of Day 1 until the morning
      of Day 2 of each period and there was a washout period of at least 2 days between treatments.
      A post study medical examination was performed prior to discharge in Period 2.

      The objective of this study was to assess the effects of a single dose of intranasal
      oxymetazoline hydrochloride on the pharmacokinetics of intranasal ketorolac in healthy male
      subjects.
    


Intervention name(s): Ketorolac tromethamine; Oxymetazoline hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): 30 mg of intranasal ketorolac tromethamine (one 100 µL spray into each nostril of a 15%, pH 7.2 solution); Single intranasal dose of oxymetazoline hydrochloride (Afrazine®) (3 sprays of a 0.05% solution into each nostril) followed 30 minutes later by 30 mg of intranasal ketorolac tromethamine (one 100 µL spray into each nostril of a 15%, pH 7.2 solution)
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Phenylephrine; Oxymetazoline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influence of a Moderate Physical Exercise Program in Health of Patients Underwent Bariatric Surgery in Talca City, Chile
Condition: Bariatric Surgery Candidate
Study type: Interventional

Summary: 
      Obesity is a multifactorial disorder resulting from multivariate etiopathogenic factors. The
      current lifestyle, causes a gradual increase in weight both in the adult population and in
      the child population. Among their treatments is bariatric surgery. About which there is
      little evidence in the literature regarding the health condition developed by patients
      operated on the same. Objective: To know the influence of a moderate exercise program on
      health status in patients operated on with bariatric surgery. Methodology: A controlled
      clinical trial, the population will consist of 32 women and 11 men. Coming from the
      consultations of bariatric surgery of the Clinic of the Maule - Talca. In the period between
      March 2017 and March 2018. It will be selected following a non-probabilistic sampling and for
      convenience. Results Analysis: The variables used in this study will be: cardiovascular
      function, respiratory function, strength, health perception, anthropometric measures and
      functional capacity to perform exercises. The Shapiro-Wilk normality test will be performed
      to determine the distribution of the data to be analyzed. The t-student test or its
      nonparametric counterpart will be applied to compare two variables. To compare three or more
      variables, the ANOVA or Kruskal-Wallis test will be used depending on the results of the
      normality test.
    


Intervention name(s): Physical activity based on a moderate exercise program
Intervention type(s): Behavioral
Intervention description(s): Physical exercise program begins with a 2-week adaptation stage, climbs onto the treadmill (HP Cosmos®). The programming of the tape will be done initially with an intensity of 40% of its FCdRes obtained from the formula of Karvonen after performing the 6-minute walk test, you will have to maintain that intensity for 15 min, the patient is evaluated with the Borg scale and oxygen saturation permanently.After two weeks of adaptation, the HRdRes becomes to be calculated, 59% of said frequency will be modified until the exercise program is completed.The training is 30 minutes in the tradmill machine.The work of muscle strengthening of biceps, triceps, deltoids and pectorals, will be progressive in intensity and number of repetitions, determined by the evaluation of 1 Rmax. The start of work with weights is 40% of the Rmax, it will be modified monthly from 40% to 75%. Cycloergometer training (Monark ®) is without load for 15 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity,bariatric surgery,physical activity
Effect of Rotigotine Patch Treatment on Cardiovascular Markers in Idiopathic Restless Legs Syndrome
Condition: Restless Legs Syndrome (RLS)
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Several studies report association between restless legs syndrome (RLS), HTA and
      cardiovascular diseases .

      The mechanisms involved in this relationship remained unknown, but several evidences favor
      the role of periodic limb movements in sleep (PLMS), patterns frequently associated with RLS.
      Sympathetic overactivity is associated with PLMS with increased pulse rate and blood pressure
      coincident with PLMS. PLMS-related repetitive nocturnal blood pressure fluctuations could
      contribute to the risk of high blood pressure, heart disease, and stroke in patients with
      RLS, especially in the elderly. Several studies already reported that dopaminergic agonists
      reduce the severity of RLS and the PLMS index.

      Do dopaminergic agonists reduce the risk of cardiovascular diseases and associated autonomic
      dysfunctions in patients with RLS ?

      Nocturnal BP (blood pressure) decline has major clinical implications, and the loss of normal
      reduction in BP during sleep is associated with high risk of cardiovascular morbidity and
      mortality.

      The main aim of this study was to evaluate the impact of rotigotine patch treatment on
      validated cardiovascular risk factors ambulatory BP during night, day and night-to-day ratio,
      and endothelial function in patients with idiopathic RLS compared to placebo.
    


Intervention name(s): Rotigotine; Placebo patchs
Intervention type(s): Drug; Drug
Intervention description(s): Subjects randomized to rotigotine will start treatment with a rotigotine dose of 1mg/24h for 1 week. The dose can be increased weekly until either the optimal or the maximal dose of 3mg/24h has been reached. Subjects will maintain the optimal/maximal dose during the 2-week Maintenance Period. Following the Maintenance Period, subjects will be de-escalated from their optimal dose by decreasing the dose by 1mg/24h every other day until complete withdrawal (Taper period).; Subject randomized on the placebo group will be treated with placebo patchs, following the same modalities and study periods that the rotigotine arm
Other intervention name(s): Rotigotine patchs
Intervention MeSH terms: Rotigotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Restless Legs Syndrome (RLS); Rotigotine; HTA; Cardiovascular diseases; Periodic Limb Movements in Sleep (PLMS); dopaminergic agonist; Sympathetic overactivity; blood pressure
The Perception of the Estomy-Individual Regarding of Its Situation
Condition: Health Promotion; Health Behavior; Pharmaceutical Services; Psychology, Clinical
Study type: Observational

Summary: 
      The present work had as purpose to analyze estomy-individuals according to the feelings of
      their current situation.
    

Detailed description: 
      The present work had as purpose to analyze estomy-individuals according to the feelings of
      their current situation. It is about a descriptive research of qualitative approach that took
      place in September, 2006. The population under study was composed by five estomy patients
      participants in a Grupo de Atenção dos Estomizados, which has multi-disciplinary character,
      at the Universidade da Região da Campanha (URCAMP) in the city of Bagé in South Brazil. The
      collection of data was given through not structuralized interviews and with the
      estomy-individuals, after the same ones read and signed the term of informed free ssent. The
      data form analyzed through the method of analysis of categories. Each one received a
      denomination with capital letters from the alphabet (A, B, D, and E) for their
      identification. The most significant categories in the answers from the ones being tested
      were manifestations and feelings of daptation, resignation and affective bond.The
      manifestation of anger and suffering shown by subjects D and E were only mentioned in this
      study, not being considered categories. The feeling shown by subjects A, B and C show an
      acceptance of their reality as rehabilitated from a surgical procedure, in the attempt of
      decreasing the psycho suffering caused by the mutilation and adaptation to the new status
      quo, fact which was observed for not appearing in the answers feeling such as revolt and
      guilty, which are mentioned in the review of literature as characteristics of subjects who
      suffered a surgical intervention. It is noticed that family support is a determinant fact to
      accept the new reality. The study contributed to know the subjectivity of the estomated,
      opening possibilities to improve the attention to health by the multi-professional staff.

      Descriptors: Perception; emotions; Adaptation; estomia
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients Estomizados of a group of visitors to estomizados support from the Center for
        Pharmaceutical Assistance at the University of the Region Campaign.
      
Keywords: Perception; Emotions; Adaptation; Estomia
Persistence Targeted Smoking Cessation in Serious Mental Illness (SMI)
Condition: Tobacco Use; Tobacco Smoking; Tobacco Use Cessation; Tobacco Use Disorder; Schizophrenia; Schizoaffective Disorder
MeSH terms: Tobacco Use Disorder; Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      Due to the pandemic, this study was modified from a randomized clinical trial to test the
      feasibility, initial efficacy, and mechanisms of action of our PTSC-S intervention to a
      feasibility and acceptability test of our intervention when delivered via telehealth in a
      single group, within-subjects design.
    

Detailed description: 
      The investigators will test the feasibility and acceptability of a telehealth-delivered
      treatment designed to help smokers with serious mental illness to quit using a therapy
      approach focused on increasing task persistence.

      We will provide free, weekly individual telehealth video counseling sessions for 8 weeks and
      10-weeks' worth of the nicotine transdermal patch (an FDA-approved smoking cessation product
      available over the counter). All sessions will be video recorded for treatment integrity and
      supervision.

      The investigators hypothesize that 1) the PTSC-S intervention will be acceptable to
      participants, and the study will be feasible to conduct. We will report prolonged and point
      prevalence abstinence rates at end-of-counseling and at 3-month follow-up (CO verified
      <8ppm).
    

Intervention name(s): Persistence Targeted Smoking Cessation in SMI (PTSC-S); Nicotine patch
Intervention type(s): Behavioral; Drug
Intervention description(s): All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth; All participants will receive 10 weeks of nicotine patch
Intervention MeSH terms: Nicotine
Intervention model: Single Group Assignment
Intervention model description: Due to the pandemic, this study was modified from a randomized clinical trial to test the feasibility, initial efficacy, and mechanisms of action of our PTSC-S intervention to a feasibility and acceptability test of our intervention when delivered via telehealth in a single group, within-subjects design.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tobacco; cigarette; schizophrenia; schizoaffective disorders; smoking cessation
A PK and Safety Study in Subjects With Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Assess the single dose PK and safety of TR701 FA in subjects with Moderate or Severe hepatic
      impairment versus matched control subjects with normal hepatic function.
    

Detailed description: 
      This study will assess the single-dose pharmacokinetics (PK) and safety of TR-701 free acid
      (FA) in subjects with Moderate or Severe hepatic impairment compared with matched control
      subjects with normal hepatic function.
    

Intervention name(s): TR-701 FA
Intervention type(s): Drug
Intervention description(s): Oral single dose 200 mg
Intervention MeSH terms: Tedizolid phosphate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Hepatic Impairment; Matched control subjects
Clinical Evaluation of Bilateral Hand Allograft: Pilot Study of 7 Cases
Condition: Amputation
Study type: Interventional

Summary: 
      The double amputation of the forearms is a rare handicap that seriously impacts the autonomy
      and the quality of life of patients, social and familial exclusion, and dependence on third
      parties for everyday activities.

      The management of these patients is nearly exclusively through the use of prostheses. Certain
      patients refuse this solution, or remain penalized by the absence of sensation, the lack of
      precision in movements, and body image issues related to the amputation; the double graft of
      hands and forearms may, in this circumstance, be the only solution.

      The objective of this pilot study was designed to evaluate the cerebral plasticity of
      patients who undergo bilateral hand allograph
    


Intervention name(s): hand allograft
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: allograft; hands; immunosuppression; fMRI
The Bioequivalence Of Two Different Lurasidone Formulations In Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I, Bioequivalent Study between 2 Formulations of Lurasidone HCl
    

Detailed description: 
      12.5% Drugload 3X40mg vs. 25% Drugload 1X120mg
    

Intervention name(s): Lurasidone HCl
Intervention type(s): Drug
Intervention description(s): 120mg dose. 3-way cross-over for 21 days
Intervention MeSH terms: Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Male/Female Patient; Reference/Test Formulation; Schizophrenia Patients
Clinical Evaluation of 2-Week Reusable ACUVUE 2 Vivid Style
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This will be a single site, non-randomized, dispensing, brand-masked to the subject,
      bilateral single treatment study. There will be 2 study visits with a 10 to 14-day contact
      lens wear period between visits.
    


Intervention name(s): JJVC Marketed Contact Lens
Intervention type(s): Device
Intervention description(s): Female subjects that are habitual contact lens wearers between the ages of 18 to 39 will be dispensed 1 treatment of the JJVC Marketed Contact Lens during the 2-visit study.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lower Abdominal Pain During Office Hysteroscopy Can Assess Tubal Patency in Infertile Women
Condition: Infertility
MeSH terms: Infertility; Abdominal Pain
Study type: Interventional

Summary: 
      Office hysteroscopy through vaginoscopic approach was done in gynecology out-patient clinic
      with saline distension medium. The presence or absence of lower abdominal pain and the side
      of pain were recorded. Then, transvaginal sonography within 20 minutes was done to detect the
      presence of free fluid in the pouch of Douglas. Then, laparoscopy with tubal
      chromopertubation was done.
    

Detailed description: 
      Office hysteroscopy through vaginoscopic approach was done in gynecology out-patient clinic
      using a 4 mm endoscopic sheath & 30 ᵒ endoscopic camera with saline distension medium using
      90-100 mmHg pressure. Meanwhile, the presence or absence of lower abdominal pain and the side
      of pain were recorded. Then, transvaginal sonography within 20 minutes was done to detect the
      presence of free fluid in the pouch of Douglas.Then, laparoscopy with tubal chromopertubation
      was done.
    

Intervention name(s): office hystroscopy
Intervention type(s): Procedure
Intervention description(s): Office hysteroscopythrough vaginoscopic approach was done in gynecology out-patient clinic using a 4 mm endoscopic sheath & 30 ᵒ endoscopic camera with saline distension medium using 90-100 mmHg pressure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Office Hysteroscopy; tubal patency; infertility; Lower Abdominal Pain
S-Condom Uterine Tamponade in Controlling Atraumatic Postpartum Haemorrhage (PPH) - RCT
Condition: Post Partum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      A Randomized Controlled Non inferiority Trial will be conducted to see the feasibility,
      acceptability and efficacy of S-Condom Uterine Tamponade in women with atraumatic PPH and not
      responding to first line of treatment.
    

Detailed description: 
      A Randomized Controlled Non inferiority Trial will be conducted to see the feasibility,
      acceptability and efficacy of S-Condom Uterine Tamponade in women with atraumatic PPH and not
      responding to first line of treatment. The women will be divided randomly into two groups, in
      both groups two condom tied on a catheter will be introduced inside the uterus. In one group
      (Control group), condom will be inflated with saline and in another group(study group) it
      will be inflated with air. Time required to stop bleeding will be measured for comparison.
      Data collected will be analyzed using a quantitative approach and the results will be
      presented in tables and graphs. If air media proved feasible, acceptable and effective the
      PPH management will be easier, cost-effective can make a great impact in reaching the target
      for reduction of maternal mortality in Bangladesh and other resource poor settings.
    

Intervention name(s): S-Condom Uterine Tamponade; Traditional condom catheter
Intervention type(s): Device; Device
Intervention description(s): The condom catheter will be inflated with air; The condom catheter will be inflated with saline following national protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two treatment strategies will be compared in this pilot study. When PPH will be diagnosed, women will receive standard treatment, 10 units of oxytocin, uterine massage and aortic compression. If bleeding continue, the control group (Group I) will be treated with condom catheter tamponade by inflating the condom with saline according to national protocol. In case of study group (Group II) the condom will be inflated with air.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Randomised controlled trial, S-condom, postpartum haemorrhage