bioihbjkbjnl/mcl2 huggingface dataset:
Multidimensional Assessment of Fatigue in Multiple Sclerosis- Observational Study - Ticino
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Fatigue
Study type: Observational

Summary: 
      Fatigue is a common symptom in patients with multiple sclerosis, however, its nature is not
      completely understood. Fatigue overlaps often with other symptoms such as somnolence,
      depression and cognitive disorders, from which it is not always readily distinguished. The
      evaluation of fatigue and the three most frequently associated symptoms using a
      multidimensional approach might allow to understand, which methodology is the best indicated
      to estimate the prevalence of fatigue with greatest accuracy, leading to a better
      differentiation of the symptoms in the diagnostic setting.
    

Detailed description: 
      Objectives: 1- to provide a detailed characterization of fatigue in a cohort of selected MS
      patients, including a definition of the boundaries and the overlaps between fatigue,
      somnolence, mood disorders and attention dysfunction; 2- to see how the prevalence and the
      overlaps between fatigue, somnolence, depression and attention dysfunction are influenced by
      the method of assessment. 3-To better characterize the sleep structure in MS patients with
      fatigue under both the macro- and microstructural point of view.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with multiple sclerosis
      
Keywords: Multiple scerlosis; Fatigue; Sleep; Somnolence; Depression; Cognitive disorders
Pregabalin and Post-thoracotomy Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      With Institutional Ethics Board approval and signed informed consent, a pilot investigation
      was conducted in which 15 adult patients scheduled to undergo a thoractomy were randomly
      assigned to receive 1) 150 mg pregabalin 1 hour preoperatively and then 7 days
      postoperatively (BID) or 2) 300 mg pregabalin 1 hour preoperatively and 7 days
      postoperatively (BID) or 3) placebo for same regimen to assess the feasibility, safety and
      compliance of this drug regimen on this patient population. This assessment was necessary in
      order to plan a future fully powered randomized controlled trial looking at the efficacy of
      perioperative pregabalin ifor reducing the incidence/severity of chronic post-thoracotomy
      pain.
    

Detailed description: 
      Chronic post thoracotomy pain syndrome (CPTPS) is a significant problem that has important
      effects on patients' daily activities. The severity of postoperative pain and the central
      sensitization associated with it are thought to play a role in the chronification of acute
      pain. Gabapentin has been shown to be effective in reducing acute post-surgical pain and
      treating CPTPS. There is conflicting data regarding its effects on the development of chronic
      post-surgical pain. Although pregabalin is similar to gabapentin there are only a few studies
      examining its use in the modification of post-surgical pain but evidence suggests that it
      might be effective. There are no studies examining the effect of pregabalin on the
      development of chronic post-surgical pain. Our hypothesis is that perioperative use of
      pregabalin will decrease the incidence of CPTPS. Our ultimate goal is to conduct a
      multi-center study assessing the effect of perioperative oral pregabalin on the development
      of CPTPS. Prior to this, we will carry out a prospective, randomized, placebo controlled,
      double-blinded pilot study to assess the feasibility, safety, and compliance associated with
      perioperative use of oral pregabalin in patients undergoing video assisted thoracotomy
      surgery (VATS) or open thoracotomy procedures.
    

Intervention name(s): Pregabalin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PHASE 1 (N=3) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.
PHASE 2 (N=4) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.; An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op (N=8)
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thoracotomy; Post-surgical; Pregabalin
Platelet Rich Plasma and Hydrodissection for Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with
      involving compression of the median nerve in the carpal tunnel. Rather than other progressive
      disease, CTS is characterized by remission and recurrence. Although many conservative
      managements of CTS, the effectiveness of these methods is insignificant or only persist for a
      short duration. The platelet rich plasma (PRP) is a new and potential treatment for patients
      with kinds of musculoskeletal disorders and recent reports showed being beneficial for
      peripheral neuropathy in animal studies. Since 2014, three small clinical trials showed the
      positive effect of PRP in peripheral neuropathy included CTSin a pilot research. However,
      these studies have not entirely proved the effects of PRP on peripheral neuropathy because
      these studies enrolled small number of patients and lacked controlled design. The
      investigators design a randomized, double-blind, controlled trail to assess the effect after
      ultrasound-guided PRP injection in patients with CTS.
    

Detailed description: 
      After obtaining written informed consent, patients with bilateral CTS will been randomized
      into intervention and control side. Participants in intervention group received one-dose
      ultrasound-guided PRP injection and control side received one-dose ultrasound-guided normal
      saline injection. No additional treatment after injection through the study period. The
      primary outcome is Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and secondary outcomes
      include visual analog scale (VAS), cross-sectional area (CSA) of the median nerve, sensory
      nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was
      performed pretreatment as well as on the 2nd week, 1st, 3rd, 6th month and one year after the
      treatment.
    

Intervention name(s): platelet rich plasma; Normal saline; Ultrasound
Intervention type(s): Drug; Drug; Device
Intervention description(s): Ultrasound-guided 3cc PRP injection between proximal carpal tunnel and median nerve.; Ultrasound-guided 3cc normal saline injection between proximal carpal tunnel and median nerve.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: platelet rich plasma; Hydrodissection
Evaluating the Safety of and Immune Response to a Dengue Vaccine (TV003) in Healthy Adults, Adolescents, and Children in Thailand
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety of and immune response to two doses of a
      dengue vaccine (TV003) given 6 months apart to healthy adults, adolescents, and children in
      Thailand.
    

Detailed description: 
      Dengue infection is a leading cause of illness and death in the tropics and subtropics. The
      infection is caused by any one of four types of the dengue virus. This study will evaluate
      the safety of and immunogenicity to a vaccine (called TV003) against all four types of the
      dengue virus in healthy adults, adolescents, and children aged 12 months to 50 years in
      Thailand.

      Participants will be enrolled sequentially in four age groups (adults, adolescents, children,
      and young children), and researchers will evaluate safety data before enrolling each
      subsequent cohort. Each participant will be in the study for approximately 12 months.

      At study entry (Day 0), participants will be randomly assigned to receive either the TV003
      vaccine or a placebo vaccine for TV003. All participants will receive two doses of TV003 or
      placebo-the first dose at study entry (Day 0) and the second dose 6 months later on Day 180.
      Additional study visits will occur on Days 6, 9, 12, 15, 28, 56, 72, 186, 189, 192, 195, 208,
      236, 252, and 360.

      All study visits will include a medical history review and a physical exam. Select study
      visits will also include blood collection and a urine pregnancy test for participants of
      childbearing potential.

      At the vaccination study visits, participants will remain in the clinic for approximately 30
      minutes after each vaccination for observation and monitoring. For 20 days after each
      vaccination, participants will take their temperatures and record any symptoms. Throughout
      the entire study period, study researchers will monitor participants for suspected dengue
      infection.
    

Intervention name(s): TV003; Placebo for TV003
Intervention type(s): Biological; Biological
Intervention description(s): 10^3 plaque forming units (PFU) of rDEN1 delta 30, 10^3 PFU of rDEN2/4 delta 30(ME), 10^3 PFU of rDEN3 delta 30/31-7164, and 10^3 PFU of rDEN4 delta 30 to be administered as 0.5 mL by subcutaneous injection in the deltoid region of the upper arm or the thigh in pediatric participants; To be administered as 0.5 mL by subcutaneous injection in the deltoid region of the upper arm or the thigh in pediatric participants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study to Investigate the Efficacy and Tolerability of ESO-101 in Patients With Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, placebo-controlled, double-blind trial to evaluate the efficacy,
      tolerability, and safety of ESO-101 in adult patients with active eosinophilic esophagitis
      (EoE). Patients will be screened at 2 visits (Visit 1 and Visit 2) during which their
      eligibility will be assessed based on endoscopy-independent criteria (Visit 1) and based on
      the histologic assessment of esophageal biopsy samples taken during the screening endoscopy
      (Visit 2). Eligible patients will be randomized 2:1 to once-daily treatment with ESO-101 or
      placebo and treated for 28 days starting on Day 0. Further clinic visits will be performed at
      Day 14 (Visit 4) and Day 28 (Visit 5, end of treatment) to assess the efficacy, tolerability,
      and safety. In addition, a safety follow-up call will be scheduled 2 weeks after the end of
      treatment (Day 42, Visit 6).
    


Intervention name(s): ESO-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Daily administration in the evening at bedtime for 28 days; Daily administration in the evening at bedtime for 28 days
Other intervention name(s): Mometasone furoate (800 μg)
Intervention MeSH terms: Mometasone Furoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term
Condition: Obesity; Induction of Labor Affected Fetus / Newborn
MeSH terms: Obesity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Obesity increases the risk of pregnancy complications, including among others puerperal
      infections and cesarean delivery, and risk rises with increasing body mass index (BMI). Class
      III obesity is an indication for delivery by 39 weeks, and these patients have a high rate of
      labor induction. In nulliparous women from the general population (obese and non-obese),
      labor induction at 39 weeks (compared to expectant management) is associated with less
      morbidity and a lower cesarean rate. Antibiotic prophylaxis, standard before cesarean
      delivery, is associated with less post-cesarean infection if azithromycin is added to the
      standard cefazolin. In this placebo-controlled pilot trial, investigators will estimate the
      parameters necessary to calculate the sample size for a planned multicenter clinical trial of
      prophylactic antibiotics administered at the start of labor inductions of morbidly obese
      nulliparous women at term.
    

Detailed description: 
      Investigators will enroll consenting women delivering at The Children's Hospital at OU
      Medical Center who meet enrollment criteria. Flyers will be distributed to providers to give
      to women who may be eligible for the study at prenatal visits, so that they may review the
      information prior to presenting for their induction of labor. Labor induction may be a
      scheduled procedure. However, many inductions occur in an unscheduled fashion due to medical
      or obstetric indications. Therefore, it is difficult to predict which women will ultimately
      require labor induction and at what gestational age they will require it, so it is not
      feasible to approach and consent all women during a clinic visit prior to labor induction.
      Distribution of flyers will allow patients to have information about the study prior to
      presenting for labor induction. Furthermore, unlike women in spontaneous labor, women being
      consented just prior to a labor induction are not vulnerable in the same way as one might
      consider a patient in labor, since they will not have the distraction and discomfort of
      uterine contractions that are presenting in laboring patients.
    

Intervention name(s): Cefazolin; Placebo; Azithromycin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): intravenous drugs used as prophylactic antibiotics; Intravenous saline; prophylactic antibiotic
Other intervention name(s): Saline
Intervention MeSH terms: Azithromycin; Cefazolin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled clinical trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Probiotic on Rhinovirus Induced Colds
Condition: Common Cold
MeSH terms: Common Cold
Study type: Interventional

Summary: 
      This is a randomized, double-blind placebo controlled trial to evaluate the effect of a
      probiotic (Bl-04) on the occurrence of rhinovirus-associated common cold illness in the
      experimental rhinovirus challenge model. A previous study documented that Bl-04 has
      significant effects on the innate immune response in the nose and this study will be powered
      to assess whether these effects translate into a demonstrable clinical benefit. Volunteers
      will be given Bl-04 or placebo for 28 days then challenged with rhinovirus. The primary
      analysis will be on the proportion of volunteers who develop a rhinovirus associated illness
      in the two treatment groups.
    


Intervention name(s): Bifidobacterium animalis subsp. lactis Bl-04; sucrose
Intervention type(s): Biological; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Preoxygenation With Nasal Cannula and Noninvasive Positive Pressure Ventilation
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      This is a prospective randomized cross over study of healthy volunteers comparing end-tidal
      oxygen concentration among subjects undergoing continuous positive airway pressure
      ventilation via a noninvasive ventilation (NIV) mask with and without the addition of nasal
      cannulas.
    

Detailed description: 
      Noninvasive positive pressure ventilation with the addition of a nasal cannula is a useful
      technique to pre-oxygenate and provide apneic oxygenation in hypoxic patients undergoing
      emergency airway management. This study aims to evaluate preoxygenation by quantifying
      end-tidal oxygen (etO2) concentration resulting from nasal cannula placement underneath a
      noninvasive positive pressure ventilation (NIPPV) mask. This is a prospective randomized
      cross over study of healthy volunteers undergoing continuous positive airway pressure
      ventilation via a noninvasive ventilation (NIV) mask with and without the addition of nasal
      cannulas. End-tidal oxygen concentration will be measured by an oxygen sensor following three
      minutes of NIPPV with and without the addition of a nasal cannula, with each subject serving
      as his or her own control.
    

Intervention name(s): Ventilation with nasal cannula; Ventilation without nasal cannula
Intervention type(s): Device; Device
Intervention description(s): Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear) while simultaneously wearing nasal cannula (Carefusion AirLife Standard Nasal Cannula) with 15 L/min oxygen flow. Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E).; Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear). Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste
Condition: Pulp Necrosis
MeSH terms: Dental Pulp Necrosis; Necrosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine the treatment outcomes in permanent teeth with
      necrotic pulp and immature root development that undergo a regenerative procedure using a
      triple antibiotic paste (ciprofloxacin, metronidazole, minocycline) versus a double
      antibiotic paste (ciprofloxacin, metronidazole)compared to the commonly used mineral trioxide
      aggregate (MTA) apexification treatment.
    

Detailed description: 
      Recent case series have reported positive outcomes treating necrotic immature permanent teeth
      with a regenerative procedure using a triple antibiotic paste (ciprofloxacin, metronidazole,
      minocycline). However, this method can result in considerable staining due to minocycline. In
      this randomized clinical trial, we will compare clinical outcomes of a triple antibiotic
      paste versus a double antibiotic paste (ciprofloxacin, metronidazole) intracanal medicament
      as compared to a standard treatment (immediate apexification with MTA) in permanent teeth
      with necrotic pulps and immature root development. We hypothesize there will be no
      significant differences between radiographic measures of root development after treatment
      with either the double versus triple antibiotic paste, and that both methods will produce
      significantly greater increases in root length and width compared to standard treatment. The
      primary outcome measures will be radiographic measurement of root length and dentinal wall
      thickness and the secondary outcomes will be lack of clinical symptoms and crown staining.
    

Intervention name(s): Double Antibiotic Paste; Triple Antibiotic Paste; Mineral Trioxide Aggregate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ciprofloxacin and metronidazole powder mixed at a 1:1 ratio used as a intracanal medicament for disinfection.; ciprofloxacin, metronidazole & minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection.; standard material providing an apical barrier
Intervention MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Regeneration (revascularization) of dental pulp; Immature permanent tooth with a diagnosis of
Radiotherapy in Primary Mediastinal Lymphoma
Condition: Adjuvant Radiotherapy on Complete Remission Patients
MeSH terms: Lymphoma
Study type: Observational

Summary: 
      The use of Rituximab has been proposed to be useful and avoid the use of radiotherapy in
      diffuse large B-cell lymphoma with bulky disease.We assess efficacy of adjuvant radiotherapy
      in patients treated with R-CHOP
    


Intervention name(s): no drugs
Intervention type(s): Radiation
Intervention description(s): Adjuvant radiotherapy 3.5 G will be administered or not (control group) in patients with mediastinal lymphoma,treated with R-CHOP
Other intervention name(s): no applicable
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with primary mediastinal lymphoma treated in an tertiary medical center
      
Keywords: primary mediastinal lymphoma; radiotherapy; chemotherapy; rituximab
Efficacy of Combination of Trastuzumab to Gemcitabine - Platinum Advanced or Metastatic Urothelial Carcinoma
Condition: Recurrent Bladder Cancer; Stage IV Bladder Cancer; Transitional Cell Carcinoma of the Bladder
MeSH terms: Carcinoma; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      A multicenter, randomized, Phase 2 trial to study the effectiveness and feasibility of
      association of trastuzumab with combination chemotherapy in advanced or metastatic bladder
      cancer patients. Combining monoclonal antibody therapy with combination chemotherapy may
      improve treatment efficacy on tumours overexpressed HER 2.
    


Intervention name(s): Trastuzumab; Gemcitabine; Carboplatin; Cisplatin
Intervention type(s): Biological; Drug; Drug; Drug
Intervention description(s): Bottles of 150 mg; Charging dose: 8mg/kg then 6mg/kg every 21 days given IV; Given IV, 1000 mg/m² BSA on Day 1 and Day 8 every 21 days; Given IV: AUC 5 on Day 1 every 21 days; Given IV, 70 mg/m² BSA on day 1 every 21 days
Other intervention name(s): anti-c-erB-2; Herceptin; MOAB HER2; dFdC; difluorodeoxycytidine hydrochloride; Gemzar; gemcitabin hydrochloride; Carboplat; CBDCA; JM-8; Paraplat; Paraplatin; cis-Diamminedichloroplatinum(II); Platinum Diamminodichloride; Diamminodichloride, Platinum; cis-Platinum; cis Platinum; Dichlorodiammineplatinum; cis-Diamminedichloroplatinum; cis Diamminedichloroplatinum; cis-Dichlorodiammineplatinum(II); Platinol; Platidiam; Platino; NSC-119875; Biocisplatinum
Intervention MeSH terms: Cisplatin; Carboplatin; Gemcitabine; Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Urothelial carcinoma; Trastuzumab; Treatment