bioihbjkbjnl/mcl2 huggingface dataset:
Adductor Canal Block for Medial Compartment Knee Arthroplasty
Condition: Postoperative Analgesia; Medial Unicompartmental Knee Arthroplasty
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the affects of a single injection ultrasound-guided adductor canal
      block for patients undergoing robotic-assisted (MAKOplasty) medial UKA (unicompartmental knee
      arthroplasty). Specifically, this study will compare the adequacy of postoperative analgesia
      provided by the adductor canal block with that provided by single injection lumbar plexus
      blockade. The working hypothesis is that the analgesia provided by the adductor canal block
      will be equivalent to the analgesia provided by the lumbar plexus block. The primary outcome
      will be a comparison of verbal numerical pain scores at rest and with movement over the first
      24 hours following nerve blockade.
    


Intervention name(s): Adductor canal block; Lumbar plexus block
Intervention type(s): Drug; Drug
Other intervention name(s): Saphenous nerve block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Partial knee replacement
Comparison of a Spectral OCT/SLO With the Stratus OCT for Imaging Various Retinal Pathologies
Condition: Macular Hole; RPE Detachment; Epiretinal Membrane; Posterior Vitreous Detachment
MeSH terms: Retinal Perforations; Epiretinal Membrane; Vitreous Detachment; Dissociative Disorders
Study type: Observational

Summary: 
      The purpose of this study is to compare the newly released Spectral OCT/SLO (OTI, Toronto,
      Canada) with the Zeiss Stratus OCT (Carl-Zeiss Meditec, Dublin, CA) with regards to the
      quality of the images obtained as well as the ease of use.
    


Time perspective: Other
Keywords: Spectral OCT; SLO; Retinal Imagining
I-scan for Adenoma Detection
Condition: Colorectal Adenomatous Polyps
MeSH terms: Adenomatous Polyps; Polyps
Study type: Interventional

Summary: 
      This study is a randomized controlled trial to determine whether i-scan can improve the
      detection of conventional adenomas and sessile serrated adenomas/polyps.
    

Detailed description: 
      This is a randomized controlled trial comparing the use of i-scan (digital surface and
      contrast enhancement of the mucosa) versus standard high-definition white light for the
      detection of conventional adenomas and sessile serrated adenomas/polyps. Recent studies have
      indicated that colonoscopy is more effective in preventing cancer in the left side of the
      colon than the right side of the colon. The reasons for this difference may be partly
      biologic, in that a special group of polyps known as sessile serrated adenomas/polyps (SSA)
      are located primarily proximal to the splenic flexure. Sessile serrated adenomas/polyps share
      molecular features with a group of cancers that occur primarily in the proximal colon. These
      molecular features include CpG island methylator phenotype (CIMP) and microsatellite
      instability. These lesions are endoscopically subtle in that they are often flat, have the
      same color as the surrounding mucosa, and are hard to differentiate from normal mucosa.
      Recent studies have shown that image enhanced endoscopy can highlight the appearance of these
      lesions. This study will test whether i-scan increases the detection of conventional adenomas
      and sessile serrated adenomas/polyps in a randomized controlled trial.
    

Intervention name(s): i-scan; standard high-definition white light
Intervention type(s): Device; Device
Intervention description(s): examination will be performed with i-scan digital enhancement; examination will be performed with high-definition white light
Other intervention name(s): colonoscopy; colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Evaluation of Osseointegration Process of Dental Implants
Condition: Dental Implant Failed; Osseointegration Failure of Dental Implant
Study type: Interventional

Summary: 
      Implant stability is critical to successful osseointegration, the direct structural
      connection between the dental implant surface and bone. Implant stability must therefore be
      measured to evaluate implant success. The study evaluated the osseointegration of different
      sizes with two devices measuring stability with different methods.
    

Detailed description: 
      The 39 implants, 4.0 and 4.5 mm in diameter and 10 and 12 mm in length, in 19 patients were
      included. Hounsfield unit (HU) values obtained on cone beam computed tomography (CBCT) were
      recorded. Stabilities were measured with Periotest and resonance frequency analysis (RFA) at
      day 0 (intra-operative) and the 1st (T1), 4th (T4), and 12th (T12) weeks. Probing depth (PD)
      and bleeding on probing (BOP) scores were compared between T1 and T4.
    

Intervention name(s): Patients selection; Implnat placement; Recall visits
Intervention type(s): Other; Other; Other
Intervention description(s): Patient selection were selected according to selected criteria.; dental implants were applied as recommended by the manufacturer.; Following the operations, the stability of the dental implants was measured at the 1st (T1), 4th (T4), and 12th (T12) weeks using Periotest (Periotest M, Modautal/Germany) and Osstell (Osstell AB-W&H, Sweden) devices.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: osseointegration; dental implant; mobility
Physical Exercise, Dietary Counseling and Cognitive Behavioral Training as a Combined Intervention to Reduce Weight and Increase Workability in Health Care Workers
Condition: Overweight; Physical Capacity; Musculoskeletal Diseases; Work Ability; Sick-leave
MeSH terms: Musculoskeletal Diseases; Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate whether a 1 year worksite based life-style
      intervention can reduce body weight and increase physical capacity and subsequently reduce
      musculoskeletal disorders and increase workability in overweight health care workers.
    

Detailed description: 
      Health care workers have a high rate of musculoskeletal disorders and sick leave and a poor
      workability and physical fitness. Most studies have focused on increasing physical fitness in
      order to increase workability and to reduce musculoskeletal disorders and sick leave. Studies
      however also show that many health care workers are obese and obesity has been linked to poor
      workability.

      Limited research is available on the effect of reducing body-weight in this group in order to
      increase workability and to decrease musculoskeletal disorders and sick leave.

      This study introduces a combined worksite based lifestyle intervention consisting of physical
      exercise, dietary counseling and cognitive behavioral training aimed at reducing weight in
      health care workers.

      On specific worksites, health care workers are cluster randomized to either intervention or
      control group.

      Effects on physical capacity, body composition, musculoskeletal disorders, workability and
      sick leave are evaluated before and after a 1 year intervention period
    

Intervention name(s): Intervention-group; Control-group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Physical exercise, dietary counseling and cognitive behavioral training as a combined intervention; Invitation to attend a monthly seminar of 2 hour duration on a wide range of health related topics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Weight loss; Physical activity; Cognitive Behavioral Training
Study of SST-0225 Topical Ibuprofen Cream in the Treatment of Delayed Onset Muscle Soreness (DOMS)
Condition: Delayed Onset Muscle Soreness, DOMS
MeSH terms: Myalgia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, prospective, randomized, dual-center, double-blind, placebo-controlled,
      parallel-group study designed to determine the efficacy and safety of SST-0225 (5.4 grams,
      applied up to 6 times in 24 hours, over a 48-hour dosing period) for the treatment of pain
      associated with DOMS.
    

Detailed description: 
      This is a Phase 3, prospective, randomized, multicenter, double blind, placebo controlled,
      parallel group study designed to determine the efficacy and safety of SST-0225 for the
      treatment of pain associated with DOMS. Healthy volunteers will be recruited to undergo an
      exercise regimen designed to induce DOMS in the elbow flexor of the non-dominant arm.
      Subjects who are eligible following the exercise regimen will be randomized to receive
      treatment with SST-0225 or placebo for a 48 hour period. Subjects will be housed in the
      clinic for the first 24 hours of dosing and sent home for the second 24 hour dosing period.
      Arm pain/soreness will be assessed throughout the study using an 11-point (0-10) Numeric
      Rating Scale (NRS).

      Approximately 150 subjects will be randomized in a 1:1 ratio to SST-0225 or placebo at up to
      three study centers in the US. Subject participation will be between 12 and 26 days depending
      on the length of the initial screening period. Once a subject is randomized the duration of
      participation will be 10 days. The expected duration of the study is approximately six months
      depending on enrollment. The sample size may be increased to a maximum of 250 based on the
      results of the planned interim analysis described in Section 15.2 of the protocol.
    

Intervention name(s): SST-0225; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SST-0225 is a cream formulation for topical application. Each 5.4 g dose is formulated to topically deliver 400 mg of ibuprofen. The cream contains sodium ibuprofen and various salts.; Placebo IP will be the same vehicle as SST-0225 vehicle without the active ingredient, ibuprofen. It will be matched in appearance, smell, consistency, and color to SST-0225 topical ibuprofen cream.
Other intervention name(s): Topical Ibuprofen Cream; Placebo Cream
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Non Surgical Treatment of Periodontitis on Diabetes Control
Condition: Periodontitis; Diabetes
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of non-surgical periodontal treatment on
      the metabolic control of type2 diabetes patients. Patients with type two diabetes mellitus
      patients and confirmed chronic periodontitis will be selected and randomly assign to two
      groups. The treatment group will receive immediate full-mouth scaling and root planing
      whereas the control group will be scheduled to receive periodontal treatment at the following
      3-month visit. Plaque index, bleeding index, probing pocket depth, recessions and cervical
      attachment loss will be recorded at baseline, at six weeks and at three months. Glycated
      haemoglobin (HbA1c) and C-reactive protein (CRP) will be analysed at baseline and three
      months following enrolment.
    

Detailed description: 
      The aim of this study is to investigate the effects of non-surgical periodontal treatment on
      the metabolic control of type2 diabetes patients. Patients with type two diabetes mellitus
      patients and confirmed chronic periodontitis will be selected and randomly assign to two
      groups. The treatment group will receive immediate full-mouth scaling and root planing
      whereas the control group will be scheduled to receive periodontal treatment at the following
      3-month visit. Plaque index, bleeding index, probing pocket depth, recessions and cervical
      attachment loss will be recorded at baseline, at six weeks and at three months. Glycated
      haemoglobin (HbA1c) and C-reactive protein (CRP) will be analysed at baseline and three
      months following enrolment.
    

Intervention name(s): non-surgical periodontal treatment
Intervention type(s): Procedure
Intervention description(s): full-mouth scaling and root planing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: periodontitis; diabetes; HbA1c; inflammation
Effects of Wheat Breads on Symptoms of IBS, a Pilot Study
Condition: Irritable Bowel Syndrome; Wheat Sensitivity
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional

Summary: 
      This is randomized pilot study comparing tolerability of yeast-baked wheat bread and
      sourdough wheat bread in irritable bowel syndrome.
    


Intervention name(s): Sourdough wheat bread; Regular yeast baked toast bread; Gluten-free diet
Intervention type(s): Other; Other; Other
Intervention description(s): Gluten-free diet excluding even oats and buckwheat. Rice, quinoa, corn and potato allowed as grains/pseudo-grains
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: wheat, IBS, gluten, ATI
Laparoscopic Assisted Dismembered Pyeloplasty Versus Open Pyeloplasty in (UPJO) With Poorly Function Kidney in Pediatrics
Condition: Uretro-pelvic Junction Obstruction; Poorly Function Kidney
Study type: Observational

Summary: 
      The management of kidneys with poor function less than 10% has been the subject of debate for
      more than a decade. Some authors have recommended nephrectomy while others favor renal
      salvage (pyeloplasty). the investigators reported their experience of lap assisted
      pyeloplasty in poorly functioning kidneys in the pediatric age group, concerning on the
      benefits of a minimally invasive method for repair of UPJO, in comparison with open approach.
    


Intervention name(s): Dismembered Pyeloplasty
Intervention type(s): Procedure
Intervention description(s): dismembered Anderson-Hynes repair was performed using 5/0 absorbable suture.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Children suffered from Uretro-pelvic junction obstruction with split renal function less
        than 10%
      
Keywords: UPJO; Poorly function kidney; Laparoscopic assissted pyeloplasty; Open pyeloplasty; Pediatrics
Ascending Single-Dose and Multiple-Dose Study to Evaluate HSK31679 in Healthy Subjects and Subjects With Elevated LDL-C
Condition: Healthy; Elevated LDL-C
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, single-dose and multiple dose escalation clinical trial for HSK31679
      conducted in chinese healthy volunteers and LDL-C elevated subjects. The safety,
      tolerability, food-impact,pharmacokinetics and pharmacodynamics of HSK31679 tablet in healthy
      volunteers and LDL-C elevated volunteers will be evaluated using a randomized, double-blind,
      placebo-controlled trial design
    


Intervention name(s): HSK31679; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single or multiple oral doses of HSK31679; Matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: HSK31679; Healthy; Elevated LDL-C; Phase I
A Study Comparing a New Dosing Regimen of Clot-dissolving Drug for Mechanical Heart Valves Which Show Clots
Condition: Prosthetic Valve Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The optimal dosage and duration of administration of clot-dissolving medications for the
      treatment of patients with mechanical heart valves with clots is not known. We hypothesized
      that a large dose of the clot-dissolving medicine given initially (akin to the dose given in
      the treatment of heart attacks), might speed up the dissolution of the clot and rapidly
      restore the functioning of the mechanical heart valve.
    

Detailed description: 
      The optimal fibrinolytic strategy for left sided prosthetic valve thrombosis (PVT) is not
      known. A large initial bolus dose of streptokinase (SK) might accelerate fibrinolysis and
      restore valve function more rapidly.

      This is a prospective, randomized trial comparing 2 fibrinolytic protocols in a first episode
      of PVT. In the rapid fibrinolytic protocol (RFP) 1.5 MU of SK is given over 1 hour, followed
      if required by a 0.1 MU/h infusion. In the standard protocol (SP) 0.25 MU is given over 30
      minutes, followed by an infusion of 0.1 MU/h. Serial echocardiography and fluoroscopy will be
      done to monitor therapy. The primary end point is the occurrence of a complete clinical
      response (CCR, complete hemodynamic response without any major complication). 58 patients are
      required in each arm for detecting a 30% difference with 80% power at α=0.05.
    

Intervention name(s): Streptokinase; Streptokinase
Intervention type(s): Drug; Drug
Intervention description(s): Accelerated infusion of streptokinase; Standard dose streptokinase
Other intervention name(s): Fibrinolytic therapy; Fibrinolytic therapy
Intervention MeSH terms: Streptokinase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prosthetic valve thrombosis; Fibrinolysis; Streptokinase
Pegylated Interferon(Peg-IFN) in Reducing Relapse Rate in Patients After Discontinuation of NUC Therapy
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates whether Peg-IFN alfa-2a can reduce the recurrence rate of hepatitis B in
      96 weeks after nucleoside analogue (NUC) withdrawal.

      The HBV HBeAg-Negative patients who received NUC anti-virus treatment for 2.5 years and
      reached stopping rule in 《Chinese chronic hepatitis B prevention and treatment
      guidelines》(2010) were randomly assigned into three groups: One group discontinue the NUC
      treatment and follow up for 96 weeks,One discontinue the NUC treatment ,receive Peg-IFN
      alfa-2a 180 μg by week for 24 weeks and follow up for 72 weeks,The other discontinue the NUC
      treatment ,receive Peg-IFN alfa-2a 180 μg by week for 48 weeks and follow up for 48 weeks.
    

Detailed description: 
      NUC is a potent inhibitor of hepatitis B viral(HBV) replication, but long-term therapy may be
      required. Therefore, NUC resistance is an important clinical risk resulting from long-term
      therapy in chronic hepatitis B (CHB) management. Discontinuation of NUC is a feasible
      strategy to reduce resistance. However, the high rate of relapse after cessation of NUC
      treatment in CHB patients remains a big problem. NUC treatment of how to safely stop drug
      needs to be solved.

      Peg-IFN can clear HBV by direct anti-viral and immune regulation mechanisms including
      enhancing natural killer cell response, increased cluster of differentiation 8(CD8 +) T
      lymphocytes and other mechanisms to restore and enhance the immune response in patients with
      CHB. Response to PEG-IFN is frequently sustained after a finite treatment course due to its
      immune modulating capacity.
    

Intervention name(s): PegIFN alfa-2a
Intervention type(s): Drug
Intervention description(s): 180 μg/ 0.5 ml ,hypodermic injection once a week
Other intervention name(s): Pegasys
Intervention MeSH terms: Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Massage to Increase Well-Being and Immune Function in Dominican Children Infected With HIV
Condition: HIV Infections; AIDS
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether massage therapy can improve immune status
      and enhance well-being in children living in the Dominican Republic who are infected with
      HIV.
    

Detailed description: 
      The incidence of pediatric HIV in the Dominican Republic has been rapidly rising, while
      antiretroviral therapies are not yet readily available to slow disease progression. There is
      compelling evidence that massage therapy may enhance immune status and alter the course of
      HIV disease. Increased immune capacity and improvement in HIV disease progression markers
      have been demonstrated following massage therapy in HIV infected adolescents and adults, even
      in the absence of antiretroviral treatments. In studies with premature newborns, increased
      weight gain, decreased stress behavior, and more optimal cognitive and motor development have
      been reported following massage treatment. This study will examine the efficacy of massage
      therapy, an affordable and potentially beneficial complementary/alternative treatment, to
      promote health and enhance well-being in HIV infected children in the Dominican Republic.

      Children will be randomly assigned to receive either massage therapy or standard
      care/friendly visits twice weekly for 12 weeks. Data will be gathered to assess acceptance,
      safety, and compliance to massage therapy and to examine whether massage treatment has
      improved immune function, developmental performance, and behavioral function.
    

Intervention name(s): Massage therapy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Complementary Therapies