bioihbjkbjnl/mcl2 huggingface dataset:
Controller Medications in the Management of Bronchial Asthma
Condition: Moderate to Severe Persistent Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to know the effect of another controller medication add on to
      the inhaled corticosteroid and long acting β2 agonist on clinical symptom, lung function and
      compliance in patients of moderate to severe persistent bronchial asthma.
    


Intervention name(s): inhaled budesonide and formeterol plus oral montelukast; inhaled budesonide and formeterol plus oral doxophylline; Doubling the dose of inhaled budesonide and formeterol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1st two weeks -run in period all the participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks- Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day plus tablet montelukast (10 mg/day)orally in the evening; 1st two weeks -run in period, all participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks- Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day plus tablet doxophylline sustained release(400 mg/day)orally in the morning; 1st two weeks -run in period, all groups participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks- Metered dose inhaler (budesonide 200 mcg /puff + formeterol 6 mcg/puff) two times a day plus metered dose inhaler of budesonide (200 mcg/puff) two times a day
Intervention MeSH terms: Budesonide; Doxofylline; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Transcutaneous Electrical Nerve Stimulation in Post-operative Lung Cancer
Condition: Cancer, Lung
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      Among all cancers, lung cancer is the most common disease on the planet, accounting for 13%
      of the cases, and leading the number of deaths from malignant diseases. In Brazil, it is
      estimated that its incidence between 2018 and 2019 could be 18,704 new cases in men and
      12,503,000 new cases in women. These data take into account an estimated risk of 18.16 new
      cases for 100,000 men and 11.81 for 100,000 women, respectively occupying the second and
      fourth most frequent cases of the disease according to gender .

      Surgeries, however aggressive they may be, are one of the most viable alternatives for
      patients with PC, provided it is performed in the milder or early phase of the disease, since
      after such period this procedure may have a period degree greater than the other forms of
      treatment.

      As a consequence, the injuries that the surgical procedure can cause to patients, pain is one
      of the most influential in the patient's quality of life. It can lead the individual to a
      marked state of disability both functional and psychological, thus being determinant for the
      suffering related to the disease, thus comprising its multifactorial character, involving
      physical, emotional, socio-cultural and environmental aspects .

      For the control of pain, physiotherapy appears with features such as transcutaneous nerve
      electrostimulation, where its use for the suppression of pain has become quite feasible due
      mainly to the ease of its handling, to be noninvasive and to serve to reduce acute pain and
      chronic.

      The use of conventional transcutaneous nerve electrostimulation to support the use of
      analgesics reduced the intensity of pain in patients of the second day of thoracotomy, but
      for a longer extension of their effects, it would take a longer time to apply the resource,
      something around 24 -48 hours.
    


Intervention name(s): rehabilitation
Intervention type(s): Other
Intervention description(s): Tens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Deprexil in Subjects With Signs and Symptoms of Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the efficacy of DEPREXIL administration in combination
      with relaxation psychotherapy in the treatment of patients with signs and symptoms of
      depression. The duration of this double-blind placebo controlled phase 3 clinical trial will
      be 24 weeks. The estimated number of persons to be recruited and randomized for the study is
      200.
    


Intervention name(s): Deprexil; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): One 600 mg Deprexil tablet (Orally administered) half an hour after each meal (breakfast, lunch and dinner), for 24 weeks. A 20 minutes relaxation psychotherapy will also be provided once a week.; One Placebo tablet (Orally administered) half an hour after each meal (breakfast, lunch and dinner), for 24 weeks. A 20 minutes relaxation psychotherapy will also be provided once a week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Depression; Dietary supplement; Deprexil
Massage With Senna-based Laxatives Versus Senna-based Laxatives in Managing Overflow Retentive Stool Incontinence
Condition: Massage
MeSH terms: Fecal Incontinence
Study type: Interventional

Summary: 
      This study aimed to evaluate the effect of abdominal massage with senna-based laxative in
      managing overflow retentive stool incontinence in pediatrics.
    

Detailed description: 
      Much attention has been devoted to children with overflow retentive stool incontinence (ORSI)
      by the pediatric surgeons, as the referral of such cases from pediatric facilities is
      constantly increasing. An important initial step in managing these children is the exclusion
      of Hirschsprung's disease starting by water-soluble contrast enema.

      Conservative management of ORIS is generally successful. The aim of the treatment is to
      achieve and maintain regular bowel movements free of symptoms Laxatives remain the mainstay
      of maintenance therapy of ORSI; yet, there is no standard laxative therapy despite the
      varieties of medication currently available. New information to these queries can be
      beneficial to medical staff involved in managing overflow retentive stool incontinence in
      pediatrics, Possibly it may add new guideline of treatment with more good result , short time
      and decrease the laxative dose.
    

Intervention name(s): Abdominal massage
Intervention type(s): Other
Intervention description(s): The patients lying in comfortable relaxed supine position and physiotherapist performed slow circular clockwise movements on the abdomen, throw tangential pushing, with digital pulp, slow and gradual pressure, with fingers inclination 45 degree. The pressure applied to the abdomen on each point for 1 min, beginning with the ascending colon, transverse colon, descending colon and sigmoid; this sequence was repeated approximately 15 min. The therapist teaches the parents this technique and asked them to apply at home 3 times / day for 15 min.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: First group receives senna-based laxatives . Second group managed by abdominal massage with senna-based laxatives. Evaluation of outcome of two groups as regard to continence and radiological study.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Constipation; Laxatives; Massage
Safety and Feasibility of Atrial Deganglionation as Adjunctive Therapy for AF
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      A prospective, single arm, multi-center exploratory study of safety and feasibility in the
      treatment of patients undergoing cardiothoracic surgery.
    

Detailed description: 
      To assess the safety and feasibility of electroporation/Pulsed Electric Field (PEF) as a
      technology to achieve selective GP ablation. This treatment will be performed on 30 patients
      undergoing cardiothoracic surgery. Primary feasibility endpoint will be demonstration of
      ability to access and deliver Pulsed Electric Field energy to all of the targeted ablation
      sites.
    

Intervention name(s): Pulsed Electric Field Ablation
Intervention type(s): Procedure
Intervention description(s): Catheter ablation of Ganglionated Plexi (GP) structures on the epicardial surface of the heart during cardiothoracic surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the Effect of Rifampicin (CYP Inducer) on Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours
Condition: Solid Tumours
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-part study in patients with advanced solid tumours. Part A will investigate the
      effect of rifampicin on the PK parameters of olaparib in patients; Part B will allow patients
      continued access to olaparib after the PK phase and will provide additional safety data.
    


Intervention name(s): Pharmacokinetic sampling; Rifampicin; Olaparib tablet dosing
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): Blood sampling to measure olaparib, rifampicin and 4β-hydroxycholesterol; Rifampicin (CYP inducer) 600mg taken once daily from Day 5 to Day 14 (Part A); Olaparib 300mg tablet taken on Days 1 and 14 (Part A). Part B dosing is 300mg olaparib bi-daily
Intervention MeSH terms: Rifampin; Olaparib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: oncology, cancer, tumour, anticancer drug, pharmacokinetics, olaparib, rifampicin, neoplasm, CYP P450 inducer
A Trial of the Safety and Efficacy of K-604 for the Treatment of Atherosclerosis
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of K-604 for the treatment
      of atherosclerosis.
    


Intervention name(s): K-604; Placebo
Intervention type(s): Drug; Other
Intervention description(s): K-604 is given for 26 weeks; placebo tablets are given for 26 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: atherosclerosis; carotid artery disease
The Effect of Oxytocin on the Consolidation of Trauma-Associated Memories
Condition: Intrusive Memories; PTSD
Study type: Interventional

Summary: 
      The purpose of the study is to examine whether oxytocin and certain polygenic risk scores
      affect the development of intrusive memories, a cardinal symptom of PTSD.
    


Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Drug: Oxytocin nasal spray; Drug: Placebo nasal spray
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Chicago is an epicenter for asthma health disparities in the U.S., with African-American
      children 5-11 yrs bearing a disproportionate share of the burden. Among the most visible of
      these disparities is the high rate of visits to the Emergency Department (ED) for
      uncontrolled asthma. Clinical uncertainties regarding the real-world effectiveness of
      guideline recommendations for ED discharge and strategies to reduce environmental triggers at
      home contribute to practice variation and poor adherence to guidelines. The CHICAGO Plan
      tests both ED- and home-level interventions to improve clinically meaningful outcomes in a
      minority pediatric ED population with uncontrolled asthma.
    


Intervention name(s): CAPE; CHW home visits
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Decision support and communication tool to promote guideline-recommended care by providers and use of such care by children/caregivers; Home visits by community health workers (CHW) to assist children and their caregivers to implement the CAPE and other guideline-recommended competencies.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: community health worker; emergency; asthma
The Study on Effects of Acute Exposure to High Altitude Hypoxia on Cognitive Function in Lowlanders
Condition: Cognition
MeSH terms: Altitude Sickness; Hypoxia
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to investigate the impact of rapid elevation to 3,800 meters on
      the cognitive function of low-altitude residents through a plateau field and plain control
      study, and explore the objective indicators related to the impaired cognitive function.
    

Detailed description: 
      This study intends to recruit 60 healthy young people residing in plain area to 3000 m.
      Participants were divided into two groups: the plateau group (N=30) and the plain group
      (N=30).

      Firstly, we collected baseline data one week before the plateau group rushed to the plateau,
      and then repeated the above data collection at the same time on day 1 (3-5 hours after
      arrival), day 2, day 3, day 5, and day 7 after entering the plateau. The plain group was
      studied in the plain according to the same test plan.

      Finally, analyze and find out the main types of cognitive impairment, and explore the
      physiological prediction index, including exploring the characteristics of EEG changes before
      and after entering the plateau.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        According to the inclusion and exclusion criteria, this study intends to recruit 60
        subjects from the healthy young and middle-aged people who live in the plain for the first
        time, such as students for internship in Tibet for the first time, cadres for aid to Tibet
        for the first time, and tourists for the first time.
Immunotherapy With TG4040 in Treatment-naïve Patients Chronically Infected With Hepatitis C Virus
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to determine the safety of sub-cutaneous (SC) injections of TG4040
      in non-cirrhotic, treatment-naïve patients chronically infected with HCV (genotype 1).

      Patients will be sequentially treated at an escalting dose of TG4040. All patients will be
      followed up to at least 6 months after his/her first injection. In addition, all patients
      treated at the highest dose will receive a TG4040 boost injection 6 months after the first
      injection, and will be followed up during an additional 6-month period.
    

Detailed description: 
      The first nine patients will be sequentially treated in three cohorts of three patients, i.e.
      they will receive 3 SC injections of TG4040 on Days 1, 8 and 15, at the dose of 10e6 pfu
      (first cohort), 10e7 pfu (second cohort), or 10e8 pfu (third cohort).

      There will be a one-week safety interval between the first injection of the patients of a
      given cohort, and a two-week safety interval between the last injection of the last patient
      of a given cohort and the first injection of the first patient of the next one. There will be
      also a two-week safety observation period after the last injection of the last patient of the
      third cohort. If the dose of 10e8 pfu does not raise safety problems, then 6 patients will be
      further enrolled, without safety intervals between patients. They will receive 3 SC
      injections of TG4040 at the dose of 10e8 pfu, on Days 1, 8 and 15.

      All patients will be followed up to at least 6 months after his/her first injection. In
      addition, all patients treated at the dose of 10e8 pfu will receive a TG4040 boost injection
      6 months after the first injection, and will be followed up during an additional 6-month
      period.

      Three additional cohorts of 9 patients will receive a boost injection either at 2, 4 or 6
      months.
    

Intervention name(s): MVA-HCV (Immunotherapy)
Intervention type(s): Biological
Intervention description(s): MVA-HCV
Intervention MeSH terms: Immunomodulating Agents
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Study on the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure
Condition: Helicobacter Pylori
Study type: Observational [Patient Registry]

Summary: 
      The patients who accepted the quadruple eradication program of the helicobacter pylori but
      failed to eradicate helicobacter pylori will be assessed the most suitable re-eradication
      time of helicobacter pylori.
    

Detailed description: 
      Helicobacter pylori (HP) infection is a common global infectious disease, which is an
      important cause of chronic gastritis, peptic ulcer and gastric cancer.

      At present, due to the non-standard Helicobacter pylori eradication program in clinical work,
      poor patient compliance and other reasons, the phenomenon of HP eradication treatment failure
      is more and more common. However, there is still no conclusion on the most appropriate time
      for remedial treatment in patients with Hp eradication failure.
    

Intervention name(s): Amoxicillin , Levofloxacin and Esomeprazole; Amoxicillin , Furazolidone and Esomeprazole; Tetracycline , Furazolidone and Esomeprazole; Amoxicillin,Levofloxacin and Vonoprazan fumarate; Amoxicillin,Furazolidone and Vonoprazan fumarate; Tetracycline,Furazolidone and Vonoprazan fumarate
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Esomeprazole-Bismuth-Amoxicillin-Levofloxacin-containing quadruple regimens; Esomeprazole-Bismuth-Amoxicillin-Furazolidone-containing quadruple regimens; Esomeprazole-Bismuth-Tetracycline-Furazolidone-containing quadruple regimens; Amoxicillin-Levofloxacin-Vonoprazan fumarate-containing quadruple group; Amoxicillin-Furazolidone-Vonoprazan fumarate-containing quadruple group; Tetracycline-Furazolidone-Vonoprazan fumarate-containing quadruple group
Intervention MeSH terms: Amoxicillin; Levofloxacin; Ofloxacin; Tetracycline; Furazolidone; Esomeprazole
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The patients in Shandong province,aged between 18 and 70 years old, with positive H. pylori
        infection that was eradicated by previous therapies but failed are included.
      
Keywords: Re-eradication time; Remedial treatment
Knot Burial Technique for Rectus Sheath Closure
Condition: Cesarean Section Complications
Study type: Interventional

Summary: 
      Caesarean section is one of the most commonly performed abdominal operations on women in most
      countries of the world. Its rate has increased markedly in recent years, and is about 20-25%
      of all child-births in most developed countries.

      The present study was a step to reduce postoperative pain in cesarean sections. Because of
      the large number of women that undergo caesarean section, even small differences in
      post-operative morbidity rates due to different techniques could translate into improved
      health and significant savings of cost and health services resources.

      Closing the rectus sheath in cesarean sections with the knots pricking through the skin
      causes significant postoperative pain, discomfort and delayed ambulation. No comments in
      literature regarding the best way for closing the rectus sheath in cesarean sections.

      AIM/ OBJECTIVES The aim of this study is to assess the efficacy of burying knots beneath the
      rectus sheath during cesarean section in reducing post operative pain and discomfort.

      Study hypothesis:

      In women undergoing cesarean sections may or may not burying knots beneath the rectus sheath
      reduce the post operative pain and discomfort.
    

Detailed description: 
      Non absorbable and delayed absorbable monofilament materials require meticulous care to
      prevent knot slippage.

      One common problem that arises from use of these materials is the discomfort caused by the
      knot pricking through the skin. Although this is a common problem after cesarean section, it
      is often overlooked and only very few preventive techniques have been described.

      This study is to assess the efficacy of burying knots beneath the rectus sheath during
      cesarean sections in reducing post operative pain and discomfort.

      Type of Study : A randomized controlled clinical trial. Study Setting :this study will be
      conducted at the department of Obstetrics and Gynecology at Ain-Shams University Maternity
      hospital.

      Study time: 2019. Study Population : The study population comprises pregnant women,
      fulfilling the inclusion criteria, attending to Ain Shams University Maternity Hospital,
      during the study period, who are planned for cesarean delivery.
    

Intervention name(s): knot burial technique; classical closure
Intervention type(s): Procedure; Procedure
Intervention description(s): surgical suturing intervention; surgical suturing intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: we will analyze 400 candidate for elective cesarean sections, divided into two groups ,each of 200 patients according to the rectus sheath closure:
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
A Study to Evaluate the Drug-drug Interactions (DDIs) of GP681 With Rosuvastatin, Digoxin, Itraconazole, Oseltamivir in Chinese Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a four-part, single-center, Open label phase I clinical study to characterize
      the DDIs potential of GP681 With Rosuvastatin, Digoxin, Itraconazole or Oseltamivir in
      Chinese healthy volunteers. This study also aims to evaluate the safety and tolerability of
      GP681 in the presence of Rosuvastatin, Digoxin, Itraconazole, or Oseltamivir.
    

Detailed description: 
      GP681 is a potent polymerase acidic (PA) protein endonuclease inhibitor. This study will be
      run in four parts to characterize the DDIs potential of GP681 with the expected concomitant
      drugs (Rosuvastatin, Digoxin, Itraconazole, Oseltamivir) in Healthy Subjects. Each part of
      this study consists of a screening period (Day -14 to Day -1), a baseline period (Day -1), a
      treatment period, and a follow-up telephone call for safety.
    

Intervention name(s): GP681; Rosuvastatin; Digoxin; Itraconazole; Oseltamivir
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): GP681, tablet, oral; Rosuvastatin, tablet, oral; Digoxin, tablet, oral; Itraconazole, capsule, oral; Oseltamivir, capsule, oral
Intervention MeSH terms: Itraconazole; Oseltamivir; Digoxin; Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment