bioihbjkbjnl/mcl2 huggingface dataset:
Dynamic Alterations of Th2/Th1 With New Onset of Community-acquired Severe Sepsis Patients
Condition: Sepsis
MeSH terms: Sepsis; Toxemia
Study type: Observational

Summary: 
      To evaluate the dynamic alterations of Th2/Th1 for the prediction of clinical immunity and
      how it was related to 28 day-prognosis and ICU-acquired infections among critically ill
      patients of community-acquired severe sepsis with new onset.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We enroll patients with community-acquired severe sepsis and then the patients admitted to
        ICU without the diagnosis of severe sepsis as ICU control group, and the heathy volunteers
        as healthy control group.
      
Biospecimen description: 
      whole blood, serum
    
Keywords: immunosuppression; community-acquired sepsis; mortality
Study of Fruquintinib in Patients With Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Fruquintinib administered at 5mg once daily in 4 weeks treatment cycle (three weeks on and
      one week off) was well tolerated and demonstrated encouraging preliminary clinical antitumor
      activity in patients with advanced Colorectal Cancer (CRC) in Phase Ib study.

      This study is aimed to evaluate the efficacy and safety of Fruquintinib in the treatment of
      patients with metastatic CRC who have progressed after metastatic CRC second line or above
      standard chemotherapy.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, multicenter Phase II clinical trial
      to compare the efficacy and safety of Fruquintinib plus Best Supportive Care (BSC) versus
      placebo plus BSC in patients with metastatic colorectal cancer who have progressed after
      second-line or above standard chemotherapy.

      After checking eligibility criteria, subjects will be randomized into Fruquintinib plus BSC
      group (treatment group) or placebo plus BSC group (control group) in a ration of 2:1.

      Primary Efficacy Endpoint:

      Progression free survival (PFS) (According to RECIST Version 1.1).

      Secondary Efficacy Endpoints:

      Objective Response Rate (ORR), Disease Control Rate (DCR), Overall Survival (OS).

      Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events
      (AEs) and categorized by severity in accordance with the NCI common terminology criteria for
      adverse events (CTC AE) Version 4.0.
    

Intervention name(s): fruquintinib; placebo
Intervention type(s): Drug; Drug
Intervention description(s): fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off; Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off
Other intervention name(s): HMPL-013; HMPL-013 placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Colorectal cancer; Fruquintinib; 013
A Study to Evaluate the Safety and Tolerability of Arbaclofen Placarbil (XP19986) in Subjects With Acute Back Spasms
Condition: Back Pain
MeSH terms: Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate safety and tolerability of arbaclofen placarbil
      sustained release tablets taken every 12 hours compared to placebo in subjects with acute
      back spasms in the lumbar region.
    


Intervention name(s): Arbaclofen placarbil, 20 mg; Placebo; Arbaclofen placarbil, 30 mg; Arbaclofen placarbil, 40 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): tablets; tablets; tablets; tablets
Other intervention name(s): XP19986 SR3; Sugar Pill; XP19986 SR3; XP19986 SR3 tablets
Intervention MeSH terms: Arbaclofen placarbil; Baclofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acute back pain in the lumbar region
REHIT Versus SMIT in Sedentary Young Women
Condition: Sedentary Behavior
Study type: Interventional

Summary: 
      Reduced-exertion high-intensity training (REHIT) is a novel form of exercise known for being
      non-classical, time-efficient, and effective on different populations. However, REHIT was
      scarcely tested on sedentary women with mortality risks. The aim of the study is to compare
      the effects of REHIT versus short moderate-intensity training (SMIT) on functional capacity,
      resting heart rate (RHR), and activity enjoyment in sedentary young women.
    

Detailed description: 
      The aim of the study is to compare the effects of reduced-exertion high-intensity training
      (REHIT) versus short moderate-intensity training (SMIT) on functional capacity, resting heart
      rate (RHR), and activity enjoyment in sedentary young women. Therefore, sedentary young women
      will be randomly allocated to either a: i) REHIT group or ii) SMIT group. Both groups will
      perform an intervention over 6 weeks duration for 10 minutes each session for 2
      sessions/week, but with different intensities (REHIT or SMIT). Both forms of exercise will be
      conducted on a cycle ergometer with the subjects monitored throughout the intervention.
      Before and after the 3-week intervention, functional capacity (6-minute walking test) and RHR
      will be measured. Additionally, physical activity enjoyment (Physical Activity Enjoyment
      Scale) will be assessed after the intervention.
    

Intervention name(s): Reduced-exertion high intensity training; Short moderate intensity training
Intervention type(s): Other; Other
Intervention description(s): The intervention of the REHIT group will consist of three parts: i) 3 minutes of warm-up part at 50% of HRmax obtained in the effort test; ii) 3 min 20 sec to 3 min 40 sec of REHIT; and iii) 3 minutes of cool-down at 50% of HRmax obtained in the effort test. The REHIT part will consist of maximum cycling sprints of all-out exercise at 100% of the HRmax, increasing for up to 10 seconds, 15 seconds on week two and 20 seconds on week three. Then, 3 minutes of active rest at 50% of HRmax. Finally, 10 seconds of all-out exercise at 100% of the HRmax, rising to 15 seconds on week two and 20 seconds on week three.; The SMIT group will receive a short moderate-intensity training with the same warm-up and cool-down exercises as the REHIT group. In addition, the main part of the session consisted of 6 minutes of moderate intensity exercise at 60-70% HRmax obtained in the effort test. In addition, the main part of the session increases 3 min every week as 6 min for the first 2 weeks, 9 min for the 3rd and 4th weeks, and 12 min for the last two weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: High-intensity training; Moderate intensity training; Sedentary young women
r-ESWT in Moderate Knee Osteoarthritis
Condition: Orthopedic Disorder
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Musculoskeletal Diseases
Study type: Interventional

Summary: 
      This study aims to compare the efficacy of r-ESWT treatment with sham-ESWT on pain, walking
      speed, physical function, and isokinetic muscle strength in knee osteoarthritis.
    

Detailed description: 
      Extracorporeal shock wave therapy (ESWT) has been increasingly used to help relieve pain and
      to remedy musculoskeletal disorders in recent years. ESWT seems to be an effective treatment
      modality many different musculoskeletal conditions, including rotator cuff tendinopathies,
      calcifying tendinopathy of the shoulder, lateral epicondylitis, greater trochanteric pain
      syndrome, patellar tendinopathy, achilles tendinopathy, plantar fasciitis, and bone
      disorders. ESWT seems to have chondroprotective, anti-inflammatory, neovascularization,
      anti-apoptotic, and tissue regeneration effect on tissues which could be relevant in the
      treatment of OA.
    

Intervention name(s): ESWT
Intervention type(s): Device
Intervention description(s): Extracorporeal shock wave therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: r-ESWT; knee osteoarthritis; pain; function
Comparison of the Effect of Traditional Method and Eras Protocol in Obesity Surgery
Condition: Obesity, Morbid; Bariatric Surgery Candidate; Obesity Adult Onset; Obesity Associated Disorder; Diabetes; Nausea; Ache; Pain, Postoperative; Postoperative Nausea; Postoperative Nausea and Vomiting; Post Procedural Discharge; ERAS; DVT
MeSH terms: Obesity; Obesity, Morbid; Nausea; Vomiting; Pain, Postoperative; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      This study was conducted to compare the effectiveness of care based on the "Accelerated
      Recovery After Surgery (ERAS) Protocol" and the traditional method in bariatric surgery and
      demonstrate the difference the two methods based on evidence.
    

Detailed description: 
      The population of the study consisted of 700 patients over the age of 18 who underwent
      bariatric surgery in the Obesity Surgery Clinic of a private hospital in 2022. The sample of
      the study included 128 patients who were willing to undergo bariatric surgery between April
      15-July 31, 2022, were in compliance with the research criteria and were voluntarily over the
      age of 18, 64 in the control and 64 in the experimental group. 128 patients in the sample
      were assigned to 2 groups using a computer program that generates random numbers. For the
      purpose of the research, groups were coded as groups A and B, and two different surgical
      preparations and surgical procedures were applied to the patients in the group. The effects
      of two different surgical method preparations and the surgical process on the patient's
      recovery were compared. In the study, the data were collected with the personal introduction
      form introducing the characteristics of the patients, the Rhodes Nausea-Vomiting and
      Regurgitation Index (WPI), the Mcgill Pain Scale and the Postoperative Evaluation Form
      created within the scope of the ERAS Accelerated Care Protocol. Permission was obtained for
      the scales, and the content validity calculation of the Postoperative Evaluation Form was
      made in line with the evaluations of the field experts consisting of physicians and nurses
      experienced in the ERAS Rapid Care Protocol. The data were analyzed in SPSS Package Program.
      While calculating frequency, percentage and standard deviation in the evaluation of the data,
      comparisons between groups were made with the independent sample t-test, and p≤ 0.05 was
      taken as the significance value of the findings.
    

Intervention name(s): Surgical Procedure with ERAS Protocol
Intervention type(s): Procedure
Intervention description(s): It covers the period before, during and after the surgery.
Other intervention name(s): Fast Track Surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: DVT; BKÖİ; DSÖ; ASA; BKI; BPD; CVI; DMAH; ERAS; FTS; IASMEN; MBT; LSG
Study to Assess the Efficacy and Safety of Reflex Plus™ in Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      Reflex plus™ is a unique blend of Collagen Hydrolysate with Rosehip extract. The blend
      contains individual ingredients which have been widely studied for its effectiveness in
      osteoarthritis(OA). Collagen hydrolysate is accumulated in the cartilage and helps to repair
      the OA, related cartilaginous changes. Rosehip works in the anti-inflammatory pathway thus
      reducing the pain and inflammation of the joint.

      The two open-label studies have showed the effectiveness of the investigational product on
      OA. The 2 studies did not show any specific safety concern to be considered. The study
      demonstrated the synergistic effect of CH and Rosehip extract from former in-vitro results in
      the formulation.

      The supplement has been manufactured in GMP certified manufacturing units in Germany and
      India under strict quality control check. Hence, quality of the supplement and batch to batch
      consistency is well assured.
    

Detailed description: 
      The purpose of this study is to assess the effect of Reflex Plus on osteoarthritis(OA)
      patients. The duration of the study is 12 / 24 weeks excluding the screening period of
      approximate 1 week. The test product being studied is Reflex Plus is composed of Collagen
      hydrolysate and Rosehip extract, it is a health supplement. It is expected to help in the
      building of cartilage for efficient joint functioning and relieving pain associated with
      arthritis It helps in cartilage protection and joint pain management.The primary endpoint of
      the study is the change in knee pain as measured by the WOMAC osteoarthritis (OA) index sum
      score between baseline and last visit in the comparison between IP and placebo.
    

Intervention name(s): Reflex Plus; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Collagen Hydrolysate: 5g ,Rosehip aqueous extract 0.55g,; Fructose,Orange flavor and sucralose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Gonarthrosis
Dexmedetomidine on Microcirculation in Septic Shock
Condition: Septic Shock
MeSH terms: Shock, Septic; Shock
Study type: Interventional
Phase: Phase 4

Summary: 
      Dexmedetomidine was found might be beneficial to sepsis. Dexmedetomidine were found to
      improve microcirculation in sepsis animal studies and non-sepsis patients. However, the
      effect of dexmedetomidine on microcirculation in septic shock patients is unknown.
    

Detailed description: 
      Septic shock is characterized by significant decline in vascular response and relative
      hypovolemia. Fluids and exogenous catecholamines are mainstay. However, even after initial
      resuscitation, microcirculatory dysfunctions still exist, and represent a direct physiologic
      link to organ failure and death. Therefore, therapeutic strategies aiming at improving
      microcirculation are performed.

      Dexmedetomidine was found might be beneficial to sepsis. Dexmedetomidine were found to
      improve microcirculation in sepsis animal studies and non-sepsis patients. However, the
      effect of dexmedetomidine on microcirculation in septic shock patients is unknown.

      Based on the hypothesis that dexmedetomidine might improve microcirculation in initial
      resuscitated septic shock patients, the study was to investigate the effects of
      dexmedetomidine on microcirculation in early septic shock patients despite initial
      resuscitation. Meanwhile, to observe the possible mechanism of the effect, the correlation
      between dexmedetomidine dose and microcirculatory parameters as well as catecholamine level
      were performed.
    

Intervention name(s): Dexmedetomidine 0.7 Mcg/kg/h
Intervention type(s): Drug
Intervention description(s): CIF 0.7mcg/kg/h
Other intervention name(s): Dexmedetomidine
Intervention MeSH terms: Dexmedetomidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sepsis; Sedation; Microcirculation; Dexmedetomidine
Phase 2 Study of Ambrisentan for Liver Function Test Rescue in Pulmonary Arterial Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 study was to determine the incidence of increased serum aminotransferase
      concentrations (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST]), as
      well as the overall safety and tolerability of ambrisentan, in participants with pulmonary
      arterial hypertension (PAH), idiopathic PAH (IPAH), or familial PAH (FPAH) who had previously
      discontinued ERA therapy (bosentan or sitaxsentan) due to increased serum ALT or AST
      concentrations.
    


Intervention name(s): ambrisentan
Intervention type(s): Drug
Intervention description(s): All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
Intervention MeSH terms: Ambrisentan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study in Healthy Men to Test How Different Doses of BI 3000202 Are Tolerated and How Food Influences the Amount of BI 3000202 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The single rising dose (SRD) part of the trial investigates safety, tolerability, and
      pharmacokinetics of BI 3000202.

      The food effect (FE) part is conducted to assess the effect of food on the relative
      bioavailability of the BI 3000202 formulation.
    


Intervention name(s): BI 3000202; Placebo matching BI 3000202
Intervention type(s): Drug; Drug
Intervention description(s): BI 3000202; Placebo matching BI 3000202
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The SRD part of the trial is designed as blinded to subjects, randomised, and placebo-controlled within parallel dose groups.
In the FE part, subjects participate in a randomised, open-label, two-way crossover trial part with two treatment periods.
Masking: Single (Participant)
Primary purpose: Treatment
Intensive Management for Gestational Diabetes
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      This is a randomized clinical pilot trial designed to assess the feasibility of randomizing
      obese women with GDM to lower glycemic thresholds compared to standard care. Maternal and
      cord blood metabolic profiles, neonatal body composition, and maternal sleep quality and
      duration will also be compared between groups.
    

Detailed description: 
      The investigators will randomize 60 obese pregnant women with a new diagnosis of gestational
      diabetes using the Carpenter-Coustan criteria in a 1:1 fashion to either standard care or
      intensive therapy. Subjects will be randomized to either standard care or intensive therapy
      at the first study visit, which will occur between 12-32 weeks of gestation after they have
      completed their gestational diabetes testing. Neither patients nor their providers will be
      blinded to patient study group. All women will receive standard nutritional counseling at the
      time of diagnosis, and they will also be treated with either glyburide or insulin as dictated
      by standard care. Women will return for a second study visit between 32-36 weeks of gestation
      to assess the impact of their glycemic target groups on overall glycemic control. The
      investigators will also collect information on the type and dose of each medication required
      to maintain glycemic control in women randomized to either standard care or intensive
      therapy.

      In addition to standard glucose monitoring 4x/day (fasting and one-hour post breakfast,
      lunch, and dinner), the investigators will utilize blinded continuous glucose monitors (iPro,
      Medtronic) at each study visit. Because women with GDM are receiving active management of
      their blood sugars and dietary counseling, the investigators will assess CGM for 5
      consecutive days both at study enrollment and again between 32-36 weeks. Study participants
      will complete food diaries during their CGM monitoring to correlate food intake with glycemic
      variation. The investigators will also compare maternal and cord blood metabolic profiles,
      neonatal body composition, and maternal sleep quality and duration between groups.
    

Intervention name(s): Lower glycemic targets
Intervention type(s): Other
Intervention description(s): Women will be randomized to either standard or lower glycemic targets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Postoperative Pain and Recovery Time After Pulpotomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of this retrospective study was to compare immediate postoperative pain scores and
      the need for rescue analgesia in children who underwent pulpotomies and general restorative
      treatment and those who underwent general restorative treatment only, all under general
      anaesthesia.
    

Detailed description: 
      Ninety patients aged between 3 and 7 years who underwent full mouth dental rehabilitation
      under general anaesthesia were enrolled in the study and reviewed. The experimental group
      included patients who were treated with at least one pulpotomy, and the control group was
      treated with dental fillings only. The Wong-Baker FACES scale was used to evaluate
      self-reported pain and the need for rescue analgesia. The data were analysed using the
      Kruskal-Wallis test, two sample t- tests, chi-square tests and Pearson's correlation
      analysis.
    

Intervention name(s): pulpotomy; tooth filling
Intervention type(s): Procedure; Procedure
Intervention description(s): vital endodontic procedure; tooth filling
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Postoperative pain; child; pulpotomy; general anesthesia
A Randomized, Double-blind, Placebo- and Active-controlled Study of the Electric Current Effects of ABT-639 on the Spontaneous Activity of Pain Sensory Receptors in Patients With Diabetic Peripheral Neuropathy
Condition: Diabetic Neuropathic Pain
MeSH terms: Neuralgia; Peripheral Nervous System Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      People with diabetes can, over time develop nerve damage throughout the body with symptoms
      such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.
    


Intervention name(s): ABT-639; Placebo; Lidocaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): two 50 mg oral capsules; 2 placebo capsules; 3mg/kg infusion over 30 minutes
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Diabetic peripheral neuropathy