bioihbjkbjnl/mcl2 huggingface dataset:
A Study for Patients With Diabetes Mellitus (IOPA)
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare glycemic control (HbA1c) in Chinese patients with
      type 1 or type 2 diabetes when treated with insulin lispro low mixture and human insulin
      30/70.
    


Intervention name(s): Human insulin 30/70; Insulin lispro low mix
Intervention type(s): Drug; Drug
Intervention description(s): Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks; Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks
Other intervention name(s): LM; Low Mix; Humalog
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; type 1; type 2
Renal Effects of RIPC in Patients After Total Arch Replacement
Condition: Acute Kidney Injury; Dialysis
MeSH terms: Acute Kidney Injury
Study type: Interventional

Summary: 
      The purpose of this study is to test the hypothesis that remote ischemic preconditioning
      prevents acute kidney injury and improves clinical outcomes in patients undergoing total arch
      replacement.
    

Detailed description: 
      Acute kidney injury (AKI) is a well-recognized complication after cardio-thoracic surgeries
      and is associated with increased morbidity and mortality. Total arch replacement is reported
      with a relatively high incidence of post-operative AKI. In addition, few effective preventive
      or therapeutic interventions for AKI have been identified. A number of studies have now
      addressed renal protection as a primary outcome following RIPC. Because the mechanism of I/R
      injury are similar to those proposed for AKI after CPB, the purpose of this study is to test
      the hypothesis that remote ischemic preconditioning prevents acute kidney injury and improves
      clinical outcomes in patients undergoing total arch replacement.
    

Intervention name(s): remote ischemic preconditioning; Control
Intervention type(s): Other; Other
Intervention description(s): Remote ischemic preconditioning (RIPC) will be induced after the general anesthesia prior to the cardiopulmonary bypass by four cycles of right limber ischemia (5-min blood pressure cuff inflation to a pressure of 200mmHg or a pressure that is 50 mmHg higher than SAP and 5-min cuff deflation); Four cycles of right upper limb pseudo ischemia and reperfusion, which will be induced by 5-minute blood pressure cuff inflation to a low pressure of 20 mmHg followed by 5-minute cuff deflated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
RCT to Evaluate the Efficacy and Safety of Ivy Leaves Cough Liquid vs. Placebo in the Treatment of Acute Cough
Condition: Acute Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomized, controlled, double-blind, multi-center trial to evaluate the efficacy and safety
      of a liquid containing ivy leaves dry extract vs. placebo in the treatment of acute cough
    


Intervention name(s): Ivy Leaves Cough Liquid; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Integrative Nutrition Care Plan for the Patient With Liver and Colorectal Cancer
Condition: Malnutrition; Cancer of Colon; Cancer of Liver; Nutrition Aspect of Cancer
MeSH terms: Colorectal Neoplasms; Colonic Neoplasms; Liver Neoplasms; Malnutrition
Study type: Interventional

Summary: 
      At present, the families of cancer patients are lack knowledge and experience of nutritional
      care after discharge. As a result, cancer patients often suffer from low nutritional status
      after being discharged from the hospital.
    

Detailed description: 
      This study intends to design a home nutrition care plan to explore the effect of a home
      nutrition care plan on the nutritional status of patients with liver cancer and colorectal
      cancer at risk of malnutrition. Malnutrition or side effects often lead to natural food
      intake for patients. It is not enough to meet the nutritional requirements, so it is matched
      with dietary products to help patients more easily meet their nutritional requirements.
      Supplements are used to alleviate patients' side effects. It is hoped that they can help
      patients improve their nutritional status.
    

Intervention name(s): Nutritional consultant; Nutritional consultant + High-calorie, high-protein liquid nutrition supplement; Nutritional consultant + Liquid supplement + Powdered supplement 1 and 2
Intervention type(s): Behavioral; Dietary Supplement; Combination Product
Intervention description(s): The control group is to be consulted by the dietitian using communication software (Line) or telephone to evaluate the nutritional requirement and guide the cancer diet principles before starting the project.; At the beginning of the plan, the dietitian first calculates the patient's daily calorie intake and the ratio of the three macronutrients and guides the patients or their family members of the nutritional care plan group A to implement a daily diet with a concentrated high-calorie and high-protein liquid supplement (Commercial formula contains 425 kcal and 19.1 grams of protein).; At the beginning of the plan, the dietitian first calculates the patient's daily calorie intake and the ratio of the three macronutrients and guides the patients or their family members of the nutritional care plan group B to implement a daily diet with a concentrated high-calorie and high-protein liquid supplement (Commercial formula contains 425 kcal and 19.1 grams of protein). Meanwhile, nutrition care plan group B will be given powdered supplement 1 (containing β-glucan and gamma-aminobutyric acid) and nutritional products and powdered supplement 2 (contains water-soluble dietary fiber and probiotics).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nutrition care of cancer; Liver cancer; Colorectal cancer; Remote consultation; Nutrition supplement
The Psychology of Physical Activity
Condition: Sedentary Lifestyle
Study type: Interventional

Summary: 
      This study plans to learn more about psychosocial factors that contribute to adopting
      physical activity. The goal of this study is to improve upon existing theories of behavior
      change in order to help other people become more physically active.
    

Detailed description: 
      The purpose of this study is to examine the relationship between personal life meaning and
      purpose and physical activity maintenance in a group of previously sedentary adults starting
      new exercise programs. Participants complete questionnaires at baseline, 4 weeks, and 12
      weeks after starting an exercise program. Participants are randomly assigned to complete
      questionnaires about daily meaning, mood, and activity for the first 4 weeks or to complete 8
      random questionnaires about daily activities over the first 4 weeks. It is hypothesized that
      personal life meaning and purpose will be related to greater exercise participation at 12
      weeks.
    

Intervention name(s): Daily Surveys; Random Surveys (8)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants complete 28 daily surveys of daily meaning, mood, and physical activities.; Participants complete 8 random surveys of activities over the past 24 hours during the first 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Purpose in Life; Self-determination; Physical activity; Self-monitoring; Behavior change
Coffee Consumption for Intestinal Function Recovery After Laparoscopic Gynecologic Surgery
Condition: Postoperative Ileus
Study type: Interventional

Summary: 
      Minimally invasive surgery (MIS) has revolutionized women's healthcare. Laparoscopy is an
      excellent route of MIS. Today, laparoscopic surgery is one of the major procedure in the
      management of a gynecologic disease. It has revealed benefits of decreased morbidity, earlier
      discharged, and quicker return to normal daily activities, and shorter hospital when compared
      to abdominal approach.

      Postoperative ileus (POI) defined as an uncomplicated ileus occurring following surgery,
      resolving spontaneously within 2 to 3 days. Clinically, it is characterized by abdominal
      distension, a lack of bowel sounds, nausea, vomiting, stomach cramps, and lack of flatus. It
      leads to morbidity and delays in patient discharge from the hospital, leading to an increased
      economic burden on the healthcare system. That's why many researchers have focused on the
      prevent of postoperative ileus; many studies have investigated preventive approaches such as
      early mobilization of the patient, adequate pain control, epidural anaesthesia, hot pack
      therapy, motility agents such as metoclopramide, and alvimopan. Although POI incidence has
      lower after the laparoscopic surgery it remains a major problem during the postoperative
      period.

      Recent studies demonstrated that coffee consumption is associated with improved
      gastrointestinal function without worsening of postoperative morbidity for both open and
      laparoscopic surgery. However, until now, no studies investigating the effect of
      postoperative coffee consumption at laparoscopic gynecologic surgery. Therefore, the
      investigators performed a randomized controlled trial to assess whether coffee consumption
      accelerates the recovery of bowel function after laparoscopic gynecologic surgery.
    


Intervention name(s): coffee
Intervention type(s): Other
Intervention description(s): All patients were asked to drink the entire 150-mL amounts within 20 minutes under the supervision of a nurse or doctor. Patients were free to drink any amount of water but no more coffee, black tea, or other forms of caffeine, such as soda. Coffee and hot water were prepared with a conventional coffee machine (Nescafe Alegria; 100 g caffeine; Nestlé. Gatwick, United Kingdom).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to provide 24 months of standard of care data on participants
      previously enrolled in Study BA058-05-003 (NCT02653417).
    

Detailed description: 
      To assess the long-term effect of the anabolic drug, abaloparatide-subcutaneous (SC) versus
      placebo in the prevention of bone fracture after cessation of treatment. Participants who
      completed the 18-month Double-Blind BA058-05-003 (ACTIVE) study (NCT02653417), after
      receiving abaloparatide-SC or placebo, were enrolled in this extension study to receive 70 mg
      of alendronate (bisphosphonate) weekly for an additional 24 months. Complete details for
      Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.
    

Intervention name(s): Alendronate
Intervention type(s): Drug
Intervention description(s): Alendronate is a bisphosphonate drug that prevents bone resorption by osteoclast and is used for the treatment of osteoporosis.
Other intervention name(s): Fosamax; Alendronate sodium
Intervention MeSH terms: Alendronate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BA058; Abaloparatide-SC; abaloparatide; ACTIVExtend; osteoporosis; fracture; bone loss
Bilateral Gluteal Fascio-myo-cutaneous Flap in Treatment of Recurrent Pilonidal Disease
Condition: Pilonidal Sinus
MeSH terms: Pilonidal Sinus
Study type: Interventional

Summary: 
      Bilateral Gluteal Fascio-myo-cutaneous Advancement Flap is a modified technique used in
      Treatment of Recurrent Sacrococcygeal Pilonidal sinus
    

Detailed description: 
      Patients with recurrent pilonidal sinus disease are recruited to undergo Bilateral Gluteal
      Fascio-myo-cutaneous Advancement Flap technique under spinal anesthesia in order to prevent
      recurrence.
    

Intervention name(s): Bilateral Gluteal Advancement Flap
Intervention type(s): Procedure
Intervention description(s): Dissection of both gluteus maximus muscles from their origin in the sacrum, advancement of both muscles is conducted to the midline after creating release incisions in their fascia.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ALTO-300 in Depression (ALTO-300-004)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to collect biologically-based data for defining predictors and
      correlates of the effects of ALTO-300.
    


Intervention name(s): ALTO-300 PO Tablet
Intervention type(s): Drug
Intervention description(s): One tablet daily
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Drug-drug Interaction and Safety of RLD2301 and RLD2007 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the drug-drug interaction and safety of RLD2301 and
      RLD2007 after oral administration in healthy volunteers.
    


Intervention name(s): RLD2301; RLD2007
Intervention type(s): Drug; Drug
Intervention description(s): Take it once a day per period.; Take it once a day per period.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mechanics Analysis of Patients Having a Sigma Mobile Bearing TKA
Condition: Knee Prosthesis; Knee Replacement Arthroplasty
Study type: Observational

Summary: 
      Utilize previously developed mathematical model to determine in vivo knee mechanics
      (kinematics, forces, stresses, areas and sound) for subjects having a Sigma Posterior
      Stabilizing (PS) mobile bearing (MB) total knee arthroplasty (TKA). There are several
      hypotheses for this study, although the most prominent is: Subjects having a Sigma RP PS TKA
      will experience polyethylene bearing rotation at 10 years post-operative, similar to their
      previous evaluations at six months, two years and five years.
    

Detailed description: 
      Additional hypotheses:

        -  Subjects having a Sigma RP PS TKA will experience full ideal femorotibial contact
           mechanics.

        -  Subjects having a Sigma RP PS TKA will experience optimal cam/post mechanics.

        -  Subjects having a Sigma RP PS TKA will experience continuous axial rotation in deep
           flexion.

        -  Subjects having a Sigma RP PS TKA will experience optimal distribution of tibio-femoral
           and cam/post contact forces over a broad area on the post.

        -  Subjects having a Sigma RP PS TKA will experience a smooth transition of the cam on the
           post, not an abrupt slide as seen with fixed bearing PS TKA.

        -  The use of the sound sensors will detect cam/post contact mechanics under in vivo
           conditions.
    

Intervention name(s): Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly
Intervention type(s): Device
Intervention description(s): Sigma PS RP TKA including a polyethylene insert with 4 beads
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients are eight mobile bearing subjects that were implanted over 10 years ago with a
        custom polyethylene insert that has four beads rigidly inserted into the polyethylene
        component.
      
Keywords: Total Knee Arthroplasty (TKA); in vivo mechanics; kinematics; fluoroscopy
A Study to Evaluate the PK, Safety and Tolerability of HCP1803.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, single-dose parallel study to evaluate the pharmacokinetics, safety
      and tolerability of HCP1803 in healthy male volunteers.
    


Intervention name(s): HCP1803-3; RLD2002; HCP1904-1
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Take it once per period; Take it once per period; Take it once per period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI)
Condition: Critical Limb Ischemia
MeSH terms: Chronic Limb-Threatening Ischemia; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the efficacy and safety of ixmyelocel-T, a
      patient-specific expanded multicellular therapy, for the treatment of patients with critical
      limb ischemia (CLI). The study is a randomized, vehicle controlled (placebo)study in CLI
      patients who have no option for revascularization procedures. All patients randomized will
      undergo a small volume bone marrow aspiration in a 15-minute outpatient or in-office
      procedure. All patients will receive injections of either ixmyelocel-T or vehicle-control
      into their pre-identified index leg. Patients will be followed for 18 months.
    


Intervention name(s): Ixmyelocel-T; Placebo
Intervention type(s): Biological; Other
Intervention description(s): On Day 14, 20 intramuscular injections of ixmyelocel-T on pre-identified index leg.; On Day 14, 20 intramuscular injections of vehicle control on pre-identified index leg.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: critical limb ischemia; REVIVE; peripheral vascular disease; CLI; PAD; MSC; stem cells; cell therapy
Dentures and Dental Implants in Treating Patients Undergoing Surgery for Mouth Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: The use of dentures and dental implants may help maintain chewing and speaking
      ability following surgery to remove tumors in the mouth.

      PURPOSE: Phase II trial to study the effectiveness of dentures and dental implants in
      maintaining the ability to chew and speak in patients undergoing surgery for mouth cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine whether conventional or implant supported dental prostheses and current
           surgical reconstructive procedures restore oral function and quality of life to
           pre-cancer surgery levels in patients with early oral cancer.

      OUTLINE: Patients complete a series of objective and subjective functional tests,
      questionnaires, and baseline examinations. Within 1-5 days, patients undergo the composite
      resection, including reconstructive surgery for the mandibulectomy group. Patients in the
      maxillectomy group receive an immediate maxillary surgical obturator. Approximately 6 weeks
      after ablative surgery, some patients receive radiotherapy for 5-7 weeks.

      Patients receive 2-4 implants at 12-16 weeks after completion of radiotherapy or 8-16 weeks
      after ablative surgery. Patients then receive conventional dentures at 4-22 weeks after
      implant surgery. Implants are exposed during 27-48 weeks after placement and abutments
      connected for fabricating dental prostheses. Approximately 8 weeks are needed to fabricate
      the implant supported prosthesis.

      Patients complete quality of life and other questionnaires prior to and at 8-21 weeks after
      surgery, 16 weeks after conventional denture insertion, and then 16 weeks after implant
      supported prosthesis insertion.

      Patients are followed every 6 months for at least 3 years.

      PROJECTED ACCRUAL: A total of 62 patients (22 requiring maxillectomy and 40 requiring
      mandibulectomy) will be accrued for this study within 42 months.
    

Intervention name(s): Implant
Intervention type(s): Other
Intervention description(s): A total of 62 patients with early oral cancer will be recruited; in addition, 22 patients requiring a partial maxillectomy and 40 requiring a partial lateral mandibulectomy will be enrolled. The mandibular defects will be reconstructed with fibula free flap surgery. Following a healing period, implants will be placed and permitted to heal unloaded for six months. Conventional dental prostheses will be fabricated and used by patients for at least 16 weeks during Phase I healing before the implants are exposed and loaded. A few weeks after Phase II surgery, the patients will receive implant-supported dental prostheses.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: stage I lip and oral cavity cancer; stage II lip and oral cavity cancer; stage III lip and oral cavity cancer
Study to Compare the Bioavailability of Omeprazole 20 mg Before and After Undergoing Surgery for Morbid Obesity
Condition: Bariatric Surgery Candidate
Study type: Interventional
Phase: Phase 4

Summary: 
      The principal aim was to evaluate whether gastric bypass surgery modifies the bioavailability
      of omeprazole 20 mg at one month and six months after surgery.

      Other objectives were:

        -  To compare bioavailability of omeprazole 20 mg between patients undergo gastric bypass
           surgery and patients who avoid it.

        -  To asses other pharmacokinetic parameters, demographic parameters and drug safety.

      Study design It was planned a mixed design which intended to compare the bioavailability in
      patients with gastric bypass (before and after surgery) and control subjects matched by sex
      and body mass index (BMI) post-surgery. This was a single-dose, open-label, crossover
      bioavailability study of omeprazole in surgical group and controls.
    


Intervention name(s): Omeprazole 20mg
Intervention type(s): Drug
Intervention MeSH terms: Omeprazole
Intervention model: Sequential Assignment
Intervention model description: This was a single-dose, open-label, bioavailability study of surgical group and controls.
Masking: None (Open Label)
Primary purpose: Other
Study to Evaluate the Safety of SP-104
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the safety and tolerability of 3-day repeat-dose of SP-104 compared to naltrexone
      hydrochloride immediate release.
    

Detailed description: 
      The purpose of this trial is to evaluate the safety and tolerability of SP-104 relative to
      naltrexone immediate release capsules in healthy adults. The study is designed to test the
      hypothesis that the formulation of SP-104 will mitigate against adverse events associated
      with naltrexone.
    

Intervention name(s): SP-104; Naltrexone immediate release oral capsules
Intervention type(s): Drug; Drug
Intervention description(s): oral capsule once daily; oral capsule once daily
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment