bioihbjkbjnl/mcl2 huggingface dataset:
Benjakul Extract and Loratadine for Treatment Allergic Rhinitis Patients
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      1. To compare the effectiveness of Benjakul extract capsules at 300 mg per day with
           Loratadine drug in the treatment of allergic rhinitis patients in small group (Clinical
           Trial Phase II).

        2. To study the safety and side effects of Benjakul extract capsules 300 mg per day and
           Loratadine drug for allergic rhinitis patients.
    

Detailed description: 
      1. Group 1consists of 30 patients, taking Benjakul dosage 100 mg or 1 capsule 3 times
           daily. beforeBreakfast, lunch and dinner.

        2. Group 2 consists of 30 patients, taking Loratadine dosage 100 mg 1time daily.Taking drug
           is as follows

      Volunteers will be treated by drugs continuously for a period of six weeks. Taking three
      times a day 1 tablet before meals (breakfast, lunch, dinner), giving drug based on random.

      Volunteers groups receiving Benjakul take 1capsule 3 times daily. Volunteer groups receiving
      Loratadine take loratadine tablet first 1capsule 1 time daily and then taking placebo once 1
      capsule during the day and 1 capsule in the evening.

      Patients have to report all the 42 days (6 weeks). The blood and urine samples will be
      collected and evaluated before the treatment and later following symptoms after 21 and 42
      days (3 weeks and 6). Assessment methods to measure the nasal, other of nasal symptoms,
      assessment of quality of life and overall treatment (Global assessment),Acoustic Rhinometry
      and tools which are used to evaluate nasal congestion. measuring the narrowest
      cross-sectional area of the nasal cavity, this tool takes a short time to evaluate and can
      determine volume of nasal cavity by calculating of the CSA in the nasal cavity. In addition,
      the researchers areable to check the safety of using medications by taking blood and urine
      samples to check Hematology CBC, Lipid profile, FBS monitoring of renal function (Renal
      function test) and liver function tests (Liver Function Tests: LFTs). So, the volunteers must
      NPO before every blood drawing.
    

Intervention name(s): Benjakul Extract; Loratadine
Intervention type(s): Drug; Drug
Intervention description(s): 30 patients taking Benjakul Extract dosage 100 mg capsule 3 times daily. before Breakfast, lunch and dinner for 42 days.; 30 patients taking Loratadine dosage 10 mg capsule 3 times daily. before Breakfast, lunch and dinner for 42 days.
Other intervention name(s): Benjakul remedy; Clarityne
Intervention MeSH terms: Loratadine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Benjakul Extract; Allergic Rhinitis; Herbal Medicine
Effect of Massage on Chronic Low Back Pain
Condition: Chronic Low Back Pain (Non-specific, Uncomplicated)
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will evaluate the effectiveness of two types of massage therapy for treating
      chronic low back pain.
    

Detailed description: 
      Americans are increasingly seeking care from massage therapists for relief of chronic back
      pain. However, while initial studies suggest that massage is beneficial for back pain, we
      have no information about which of the many types of massage is most helpful. We will be
      conducting a study that compares two distinct therapeutic massage protocols with each other
      and with usual care for treating chronic back pain. This study is designed to determine which
      of these massage protocols will be most effective in reducing pain and increasing
      functionality in people with low back pain. 399 Group Health members with non-specific low
      back pain lasting at least 3 months will be randomized to one of the two massage groups or to
      a control group that receives no treatment beyond their usual care. Massage therapists will
      provide each participant with 10 treatments over 10 weeks. The primary outcomes, function and
      bothersomeness of low back pain, will be assessed before treatment begins and 10, 26 and 52
      weeks after randomization by interviewers who do not know which treatment the participant
      received. The results of this study will clarify the value of two different types of massage
      for treating one of the most common, challenging, and expensive health problems plaguing
      developed countries. The findings will help physicians make informed and confident referrals,
      consumers and insurers make safe and cost-effective choices, and massage schools make
      responsible curriculum decisions.
    

Intervention name(s): massage
Intervention type(s): Procedure
Intervention description(s): UP to 10 massages over 10 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: massage; back pain; effectiveness
Acute Phase Response & Periodontal Treatment
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases; Acute-Phase Reaction
Study type: Interventional

Summary: 
      This study has compared quadrant scaling and root planing (Q-SRP) versus intensive treatment
      performed within 24 hours (FM-SRP) in terms of acute phase responses following treatment of
      periodontal disease. The primary aim was to compare the differences in CRP acute increase
      following FM-SRP versus Q-SRP therapy (24 hours after therapy). Secondary outcomes included
      changes in a broad array of inflammatory and endothelial injury markers between groups.
      Patients were randomly assigned to either FM-SRP and Q-SRP. Data indicated that non-surgical
      periodontal therapy performed within 24 hours induced greater perturbations of systemic
      inflammation compared to conventional treatment.
    

Detailed description: 
      Aim. A moderate acute-phase response occurs 24 hours following full-mouth non-surgical
      treatment (FM-SRP). Aim of this study will be to compare quadrant scaling (Q-SRP) versus
      FM-SRP in terms of systemic acute (24 hours) and medium-term (3 months) inflammation.

      Material & Methods. 38 periodontitis-affected subjects will be randomly allocated to FM-SRP
      or Q-SRP after a baseline visit. Periodontal and anthropometric parameters, such as systolic
      and diastolic bood pressure, BMI and temperature, will be collected at baseline and 3 months.
      Serum samples will be drawn at baseline, 1, 7 and 90 days after treatment. High sensitivity
      assays for a broad array of inflammatory (PCR, IL-6, TNF-alpha) and endothelial assays will
      be performed.
    

Intervention name(s): Scaling & Root Planing
Intervention type(s): Procedure
Intervention description(s): It consists in the non-surgical debridement of the sub gingival area affected by periodontal disease
Other intervention name(s): SRP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Scaling and root planning; C-reactive protein
Surgery With or Without Radiation Therapy in Untreated Nonmetastatic Retroperitoneal Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma
Study type: Interventional

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation
      therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that
      needs to be removed. It is not yet known whether surgery is more effective with or without
      radiation therapy in treating nonmetastatic retroperitoneal soft tissue sarcoma.

      PURPOSE: This randomized phase III trial is studying radiation therapy followed by surgery to
      see how well it works compared with surgery alone in treating patients with previously
      untreated nonmetastatic retroperitoneal soft tissue sarcoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To assess whether there is a difference in abdominal recurrence-free survival between
           retroperitoneal soft tissue sarcoma patients undergoing curative intent surgery alone
           and those undergoing preoperative radiotherapy followed by curative-intent surgery.

      Secondary

        -  To assess whether there is a difference in metastasis-free survival, abdominal
           recurrence-free interval, and overall survival between these patients.

        -  To assess tumor response in patients undergoing preoperative radiotherapy.

        -  To assess toxicity of preoperative radiotherapy given prior to curative-intent surgery
           in these patients.

      OUTLINE: This is a multicenter study. Patients are stratified according to institution and
      WHO performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients undergo surgical resection of the tumor mass within 4 weeks following
           randomization.

        -  Arm II: Patients undergo 3-dimensional conformal radiation therapy (RT) or
           intensity-modulated RT within 8 weeks after randomization. RT continues 5 days a week
           for approximately 5.5 weeks. Patients undergo surgical resection of the tumor mass
           within 4-8 weeks after the completion of RT.

      Tumor tissue, normal abdominal wall fat, and peripheral blood may be collected during surgery
      to identify new prognostic factors for translational research.

      After completion of study therapy, patients are followed at day 60 post-surgery and every 6
      months thereafter.
    

Intervention name(s): therapeutic conventional surgery; 3-dimensional conformal radiation therapy
Intervention type(s): Procedure; Radiation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult angiosarcoma; adult fibrosarcoma; adult leiomyosarcoma; adult liposarcoma; adult malignant fibrous histiocytoma; adult malignant mesenchymoma; stage I adult soft tissue sarcoma; stage II adult soft tissue sarcoma; stage III adult soft tissue sarcoma
A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.
Condition: Non-alcoholic Fatty Liver Disease (NAFLD; Hypertriglyceridemia
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Overweight; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study
      performed in 2 centres in Sweden to assess the effect of Omega-3 carboxylic acids and
      fenofibrate on liver fat measured with magnetic resonance imaging (MRI) in patients with
      over-weight and hypertriglyceridemia.
    


Intervention name(s): Placebo; Omega-3 carboxylic acid; Fenofibrate 200mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo matching to Omega-3 carboxylic acids (olive oil); 4 g administered as 4 x 1 g capsules; 200mg capsule administered once daily; Placebo matching to fenofibrate 200mg
Intervention MeSH terms: Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: omega-3 carboxylic acid
AAN Robotic Therapy in SCI
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate that a robot-aided rehabilitation protocol that
      follows the "assist-as needed" paradigm provide statistically significant improvements in arm
      and hand motor functions when compared to robot-aided protocols that passively move patients'
      arms along pre-defined trajectories, in patients with incomplete spinal cord injury (SCI).
    


Intervention name(s): MAHI Exo-II
Intervention type(s): Device
Other intervention name(s): Robot-aided movement therapy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Injuries; Spinal Cord
Comparison of Aerobic, Resistance, and Combined Training in Overweight/Obese Hypertensive Adults
Condition: Obese; Hypertension
MeSH terms: Overweight
Study type: Interventional

Summary: 
      To compare the effects of aerobic, resistance and combined training in hypertensive obese
      patients
    


Intervention name(s): Aerobic exercise training Group; Resistance Exercise Training Group; Combined Exercise Training Group
Intervention type(s): Other; Other; Other
Intervention description(s): Aerobic Exercise includes Treadmill walking At Week 1-2, intensity of 40-45% Heart rate maximum (HR max), 3 days/week, for 30 minutes At Week 3-4, intensity of 45-50% HR max, 3 days /week, for 30 minutes At Week 5-6, intensity of 50-60% HR max 3 days per week, for 30 minutes; Resistive Exercises includes (a) Leg press b) Quadriceps extension c) Bicep curl d) Hip abduction.
At Week 1-2, 10 repetitions 1 set, 3 days/week, for 30 minutes At Week 3-4, 2 sets of 10 repetitions, 3 times /week for 30 minutes At week 5-6, 2 sets of 10 repetitions with 5 sec hold 3 times per week for 30 minutes; Combined Exercise training includes [Aerobic: Treadmill walking + Resistive Training: a) Leg press b) Quadriceps extension c) Bicep curl d) Hip abduction] Time will be reduced to 15 minutes for both trainings in respective weeks. Aerobic Exercise includes Treadmill walking At Week 1-2, intensity of 40-45% Heart rate maximum (HR max), 3 days/week, for 15 minutes At Week 3-4, intensity of 45-50% HR max, 3 days /week, for 15 minutes At Week 5-6, intensity of 50-60% HR max 3 days per week, for 15 minutes
Resistive Exercises At Week 1-2, 10 repetitions 1 set, 3 days/week, for 15 minutes At Week 3-4, 2 sets of 10 repetitions, 3 times /week for 15 minutes At week 5-6, 2 sets of 10 repetitions with 5 sec hold 3 times per week for 15 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Aerobic Exercise; Resistive exercise; Combined Aerobic and Resistive Exercise
Comparison of Quadratus Lumborum Intramuscular and Transmuscular in Postoperative Pain
Condition: Pain, Postoperative; Pain, Acute; Cesarean Section Complications
MeSH terms: Pain, Postoperative; Acute Pain
Study type: Interventional

Summary: 
      Acute pain is reported in approximately 80% of patients undergoing postoperative care for
      various types of surgical procedures in the United States. Another study reported patient
      postoperative pain intensity with 75% with severe pain in the first 1 to 2 postoperative days
      and 38% reporting moderate to severe pain at 14 postoperative days. Several modalities have
      been used as the standard for the management of pain postoperative C-sections.

      One of the postoperative analgesic modalities for SC is quadratus lumborum block (QLB). This
      technique has advantages in relieving postoperative pain after C-section because it is
      considered to be able to relieve visceral pain as well as somatic pain. The transmuscular QLB
      (QLBT) approach is one of the most frequently used. This technique was found to be effective
      with regard to the distribution of analgesics to the paravertebral spaces which is the
      hallmark of QLB. However, this technique was found to be difficult to perform. Difficulties
      were reported related to the position of the procedure i.e. lateral or sitting position.
    


Intervention name(s): Quadratus lumborum block after C-section surgery as postoperative pain management
Intervention type(s): Other
Intervention description(s): To manage postoperative pain, the subjects will be allocated to either QLB or QLTB group to receive the respective intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Single Dose Study Of The Safety And Investigational Product Level Measurement In Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to find the safety and side effects of investigational drug in
      healthy volunteers. See how quickly investigational drug enters the bloodstream, is
      distributed in the body, broken down and removed in healthy male and female volunteers. See
      if your body makes antibodies to this investigational drug (how your immune system responds).
    

Detailed description: 
      First in human study to collect safety and pharmacokinetics (PK) of single ascending dose in
      Healthy subjects
    

Intervention name(s): PF-05230905
Intervention type(s): Drug
Intervention description(s): Single dose subcutaneous or intravenous (IV) administration of PF-05230905 or placebo
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: Healthy subject; safety; PK study; healthy volunteers
Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Adults With Fatigue Associated With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Fatigue; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy, safety and tolerability of
      Levomilnacipran ER for the treatment of fatigue associated with major depressive disorder
      (MDD).
    


Intervention name(s): Levomilnacipran ER; Paroxetine, Sertraline, Citalopram or Fluoxetine.; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Drug: Levomilnacipran ER (40 -120 mg/day) Study drug is to be given orally, in capsule form, once daily for 8 weeks; Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks; Matching placebo capsules, oral administration, once daily dosing
Intervention MeSH terms: Milnacipran; Sertraline; Fluoxetine; Paroxetine; Citalopram; Levomilnacipran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Fatigue; Major Depressive Disorder
Hormone Estradiol Replacement Therapy Additional Herbals
Condition: Menopause
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether Hormone Replacement Therapy (HRT), safety
      studies are combined with herbal (garlic oil, rutin, and nattokinase) to reduce estrogen side
      effects. Making it safer when an endocrine supplement is needed for estrogen deficiency
      symptoms in menopausal and postmenopausal women.
    

Detailed description: 
      Recent studies have proved :

      -Garlic oil as garlic may reduce platelet aggregation, patients taking anticoagulant
      medication are cautioned about consuming garlic.

      A 2013 meta-analysis concluded that garlic preparations may effectively lower total
      cholesterol by 11-23 mg/dL and LDL cholesterol by 3-15 mg/dL in adults with high cholesterol
      if taken for longer than two months. The same analysis found that garlic had a marginally
      positive effect on HDL cholesterol, no significant effect on blood triglyceride levels, and
      that garlic preparations were generally well tolerated with very few side effects.

        -  Nattokinase Nattō is made from fermented soybeans and has been eaten in Japan for about
           a thousand years. Nattō is produced by fermentation by adding the bacterium Bacillus
           natto to boiled soybeans. Nattokinase is produced by the bacterium acting on the
           soybeans . While other soy foods contain enzymes, it is only the nattō preparation that
           contains the specific nattokinase enzyme.

        -  Estradiol valerate is one of the most widely used esters of estradiol.

        -  Progesterone: Hormone replacement therapy. Progesterone is combined with 17-beta
           estradiol in the estrogen patch.
    

Intervention name(s): ESTROGEN HERBALS 21; ESTROGEN HERBALS 28
Intervention type(s): Drug; Drug
Intervention description(s): Applies to the following strengths:
17β-estradiol 1.5mg/24 hours x 21 days, stop drinking for 7 days. Progesterone 5 mg/24 hours x 10 days, stop drinking for 7 days. Garlic oil 30mg/24 hours x 28 days. Enzyme nattokinase 300 FU x 24 hours x 28 days.; Applies to the following strengths:
17β-estradiol 1.5mg/24 hours x 28 days. Garlic oil 30mg/24 hours x 28 days. Enzyme nattokinase 300 FU x 24 hours x 28 days.
Other intervention name(s): EPGANA 21; EPGANA 28
Intervention MeSH terms: Estrogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Health Services Research
Heterosexual HIV Transmission Study (HATS). Prospective Cohort Study
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      PRIMARY: To identify factors associated with risk of HIV infection through heterosexual
      activity among urban, inner-city women.

      SECONDARY: To identify correlates of high-risk behaviors in order to provide a basis for
      future intervention studies.
    

Detailed description: 
      At baseline and at 6-month intervals, participants are interviewed about their sexual
      behavior, drug and alcohol-related behaviors, and recent medical history, and are given a
      psychosocial assessment. They also undergo a physical exam, including pelvic exam and
      colposcopy, and have blood and urine specimens collected for HIV testing, drug screening, and
      STD evaluation. Additionally, participants are given pre- and post-test counseling and
      education, including information about social services. They are provided with basic
      gynecological care and either treatment or referral for medical problems.
    

Intervention name(s): Pre- and post-test counseling
Intervention type(s): Behavioral
Primary purpose: Treatment
Keywords: Sex Behavior
Drug Interaction Study of Isavuconazole and Digoxin
Condition: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Digoxin; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of multiple doses of isavuconazole on the
      pharmacokinetics of a single dose of digoxin in healthy adult subjects.
    


Intervention name(s): Isavuconazole; digoxin
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): BAL8557; Lanoxin®
Intervention MeSH terms: Isavuconazole; Digoxin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Isavuconazole; Digoxin; Healthy Volunteers; BAL8557