bioihbjkbjnl/mcl2 huggingface dataset:
Bone Histomorphometry in Postmenopausal Men and Women With Osteoarthritis Undergoing Total Hip Replacement
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to determine the incidence of modeling-based bone
      formation in the femoral neck in participants who have received denosumab and are undergoing
      total hip replacement (THR).
    


Intervention name(s): Tetracycline; Demeclocycline; Total Hip Replacement
Intervention type(s): Other; Other; Procedure
Intervention description(s): Treatment during cycle 1 consists of a total oral dose of 1000 mg of tetracycline daily for a total of 3 days.; Treatment during cycle 2 consists of a total oral dose of 600 mg of demeclocycline daily for 3 days.; Participants entering this study were prescheduled to undergo elective THR due to osteoarthritis. Surgery was to be performed according to local standard of care. During THR a fragment of femoral bone was acquired for histomorphometry evaluation.
Intervention MeSH terms: Tetracycline; Demeclocycline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bone biopsy; tetracycline; demeclocycline; total hip replacement
A Study on Traditional Chinese Medicine (TCM) Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy
Condition: Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional

Summary: 
      1. Title: A Study on TCM comprehensive protocol of Prevention and Control in Diabetic
           Retinopathy.

        2. Objectives of study: To evaluate the Intervention effect of integrate control protocol
           on reducing the incidence rate of proliferative diabetic retinopathy, PRP and MVL. Then
           produce a high performance, optimize, convenient, applicable and demonstrated protocol
           of integrate control with Intervention of TCM and west medicine.

        3. Study Type: Interventional

        4. Study Design: Multi-center, Randomized, Blind (Subject, Investigator, Outcomes
           Assessor), Parallel Assignment, Positive controlled clinical study.

        5. Sample size: 480 subjects , divided into test and control groups equally.

        6. Primary endpoint: incidence rate of proliferative diabetic retinopathy, panretinal
           photocoagulation
    

Detailed description: 
      1. Primary outcome:

             -  proliferative diabetic retinopathy

             -  panretinal photocoagulation

        2. Secondary outcome:

             -  Vision, Funduscopy, Fundus photograph

             -  Fundus fluorescein angiography

             -  Visual Electrophysiology:FERG、OPs、PVEP.

             -  Optical coherence tomography.

             -  Symptoms scores of TCM.

             -  The M0S short-form-36 heaIth survey(SF-36).

             -  Visual Function Questionnaire-25(VFQ-25).
    

Intervention name(s): Qi ming granula; Placebo Comparator
Intervention type(s): Drug; Drug
Intervention description(s): Qi ming granula Usage:4.5g，po，tid. duration:12 months/ arise Endpoint Event; Control group: Basic therapy ＆ placebo
Therapy for DM: To control blood glucose, blood pressure, and serum lipid through drug, dietary management , exercise and education.
placebo,Usage: 4.5g，po，tid
Other intervention name(s): QM; PC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: diabetic retinopathy; traditional chinese medicine
Leptin and Visfatin in Diabetic Patients With Periodontitis Before and After Periodontal Therapy
Condition: Chronic Periodontitis; Type 2 Diabetes Mellitus
MeSH terms: Periodontitis; Chronic Periodontitis; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      1. Are adipokines involved in pathogenesis of periodontal disease in diabetic patients?

        2. Does their level change after periodontal therapy?
    

Detailed description: 
      Patients with chronic periodontitis only and patients with chronic periodontitis and diabetes
      were evaluated for levels of leptin and visfatin in the gingival tissues before and after
      non-surgical periodontal therapy.
    

Intervention name(s): non-surgical periodontal therapy
Intervention type(s): Procedure
Intervention description(s): supra and subgingival debridement
Other intervention name(s): scaling and root planing
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: leptin; visfatin; chronic periodontitis; diabetes mellitus; non-surgical periodontal therapy
The Alberta NutrIMM Study - Nutrition and Immunity
Condition: Diabetes Mellitus, Type 2; Obesity
MeSH terms: Obesity; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study will investigate the effect of body weight, diet, and high blood sugar levels,
      under controlled feeding conditions, on immune function in individuals with and without
      obesity.

      This study will be a non-randomized, four-arm parallel group, clinical trial under controlled
      feeding conditions (4-week nutritional intervention using a North American-type diet). A
      sample size of n=128 participants will be allocated into one of the following groups:

        -  Individuals without obesity and normoglycemia (NG) (Lean-NG)

        -  Individuals with obesity and normoglycemia (Obese-NG)

        -  Individuals with obesity and glucose intolerance (GI) (Obese-GI)

        -  Individuals with obesity and type 2 diabetes (T2D) (Obese-T2D)

      The following outcomes will be analyzed:

        -  Immune cell function (ex-vivo cytokine production after stimulation with mitogen and T
           cell proliferation);

        -  Immune cell phenotypes;

        -  Systemic inflammation (C-reactive protein and plasma cytokines);

        -  Glucose, insulin, glycated hemoglobin (HbA1c), and lipids;

        -  Fatty acids and phospholipds composition in plasma and red blood cells membrane.
    


Intervention name(s): North American-type diet
Intervention type(s): Other
Intervention description(s): All groups will receive an isocaloric diet for 4 weeks composed of 48% of energy as carbohydrate, 17% as protein, and 35% as lipid (12.5% of saturated fat, 13% of monounsaturated fat, and 6% of polyunsaturated fat), designed to reflect as closely as possible current macronutrient intake averages in North America/Canada.America/Canada (35% of energy as fat, 12.5% as saturated fat, 13% as monounsaturated fat, 6% as polyunsaturated fat, 48% as carbohydrate, 17% as protein)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 4-parallel arm study
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: inflammation; diabetes; obesity; lean
Mental Practice and Manipulative Skills Training in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Introduction: Multiple sclerosis (MS) is a demyelinating disease of the central nervous
      system which produces both motor and cognitive dysfunctions. MS causes a decline in the
      performance of activities of daily living (ADL) due to impairments affecting limb function.

      Aim: This pilot study sought to determine whether the use of mental practice (MP) or the
      combined use of MP and the training of manipulative skills would improve the manipulation
      motor skills and treatment satisfaction among people with MS.

      Methods: The study participants were people with MS. Blinded evaluators performed three
      assessments for each patient (pre-treatment, post-treatment and at a three month follow up).
      The patients were divided into three groups with alternate allocation: (A) Mental practice,
      (B) Mental practice + skills training and (C) Control group.

      Keywords: activities of daily living; manual dexterity; mental practice, motor image;
      multiple sclerosis.
    


Intervention name(s): Mental practice; Mental practice + skill training; Control group
Intervention type(s): Other; Other; Other
Intervention description(s): During each of the 12 treatment sessions, the patient was asked to select two tasks from a list of MP activities, graded by level. Once the task was selected, patients received the specific visual or audio instructions and subsequently performed the task. The recording was viewed three times and the audio instructions were repeated two times. To listen to the audio instructions, the participants were requested to close their eyes in order to aid concentration. After listening to the recordings, the patient was asked to perform the task once again, practicing what had been learnt. After the process was completed, the participant completed a questionnaire and scored each task.; In this option, six sessions of MP were alternated with six sessions of skills training (ST). The MP protocol was the same as in group A: selecting, performing, visualizing, listening to and scoring the selected tasks. The activities performed in the skills training were based on the Kamm et al. (2015) protocol and bimanual tasks. After the performance of each task, the patients were allowed to rest for 1 or 2 minutes to avoid the appearance of fatigue.; The control group only received their usual physical therapy and occupational therapy treatments provided by their association. The treatment mainly consisted of the application of the Bobath concept and the Vojta method, dry needling, myofascial induction therapy, passive mobilizations, training of gross and fine motor coordination of the upper limbs, resistance training and static and dynamic balance training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase 1 Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of PRTX-100 in Healthy Adult Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is the second human clinical study with PRTX-100. It is designed to assess the
      safety of a single intravenous (IV) dose of PRTX-100, as well as, how the drug is eliminated
      from the blood after dosing. Additionally, this study provides an opportunity to monitor
      immune system response to PRTX-100.
    

Detailed description: 
      A total of 20 healthy subjects will be enrolled into one of two dosing cohorts. Each dosing
      cohort will consist of 10 subjects. Within each cohort, subjects will be randomized to
      clinical trial material (CTM) (PRTX-100 or placebo) such that 8 subjects receive PRTX-100 and
      2 subjects receive placebo. The PRTX-100 doses to be assessed in an ascending fashion are:
      0.30 mcg/kg and 0.45 mcg/kg. Dosing of Cohort 2 will occur after the Investigator reviews Day
      0-14 safety data and confers with the Sponsor Medical Monitor.

      Subjects will be confined to the clinical pharmacology research unit for 5 days following
      dosing. Each cohort will have safety, pharmacokinetic, and pharmacodynamic assessments over
      the 5-day post-dose period. Subjects will also have follow-up assessments at 6, 7, 10 (±1),
      14 (±1), 30 (±2), and 60 (±2) days post-dose.
    

Intervention name(s): PRTX-100 (Staphylococcal protein A)
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Efficacy and Tolerability of Tonabersat in the Prophylaxis of Migraine Headache
Condition: Migraine Without Aura; Migraine With Aura
MeSH terms: Migraine Disorders; Migraine without Aura; Migraine with Aura; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      Overall trial objectives:

        -  Can treatment with tonabersat reduce the number of days with a migraine headache in
           patients who suffer from frequent migraine attacks

        -  How well tolerated is treatment with tonabersat

      The study is based on the hypothesis that the unique mechanism of action of tonabersat will
      inhibit some of the early events in the generation of migraine and so be effective as
      prophylactic treatment
    


Intervention name(s): Tonabersat; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablet 40mg daily for 12 weeks; Tablet once daily for 12 weeks
Other intervention name(s): SB220453
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Transcriptomic and Biochemical Changes During a Migraine Attack
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Observational

Summary: 
      Despite the fact that migraine is a common disorder, the pathogenesis is still not fully
      elucidated. Studying transcriptomic and biochemical changes during induced and spontaneous
      migraine-attacks will enhance our understanding and may point to new targets for drug
      development.
    

Detailed description: 
      Migraine is a common neurological disorder affecting approx. 16 % of the European population.
      Despite the fact that migraine is a common disorder, the pathogenesis is still not
      sufficiently known.

      Studying transcriptomic and biochemical changes during spontaneous migraine-attacks will
      greatly enhance our understanding of migraine mechanisms and may point to new targets for
      drug development.

      Two blood samples (one for RNA analysis and one for biochemical analysis) are taken on
      minimum 15 patient with migraine with aura and 15 patients with migraine without aura when
      they experience a spontaneous migraine attack. A second sample is taken 2 hours after
      treatment with subcutaneous sumatriptan. Another two blood samples are taken when the patient
      has been migraine free for at least 5 days and had no other headache for at least 24 hours. A
      fourth set of blood samples are collected after a cold pressor test.
    

Intervention name(s): Blood samples
Intervention type(s): Other
Intervention description(s): There is no intervention, but we will take blood samples during a spontaneous migraine attack
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        15 patients with migraine without aura and 15 paitients with migraine with aura
      
Biospecimen description: 
      Bloodsamples
Safety and Efficacy of Long Limb Roux-en Y Reconstruction
Condition: Diabetes Mellitus Type 2 in Nonobese; Gastric Cancer
MeSH terms: Stomach Neoplasms; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      We grafted the concept of metabolic surgery (long limb Roux-en Y reconstruction) into gastric
      cancer surgery. This study aimed to investigate the safety and efficacy of long limb Roux-en
      Y reconstruction after gastrectomy in non-obese type II diabetes with gastric cancer.
    

Detailed description: 
      Type II diabetes in the world is increasing rapidly, and it is known that patients with type
      II diabetes with morbid obesity that underwent bariatric surgery have resolution of impaired
      glucose metabolism.

      In Asia, most type II diabetes are not morbidly obese and still, it is controversy whether
      metabolic surgery is effective or not in non-morbid obese patients. As life expectancy is
      increased, the number of patients with gastric cancer and T2DM is increased as well.

      Recently, we studied the outcome of T2DM after gastrectomy and conventional reconstruction in
      non-obese gastric cancer patients.(Kim JW et al, World J Gastroenterol 2012;18:49) The study
      was a large-series retrospective study including about 400 patients and the result regarding
      DM improvement was not satisfactory. Based on our previous results, it is needed to find more
      effective way to resolve the type II diabetes in gastrectomized patients with gastric cancer.
    

Intervention name(s): Long limb Roux-en Y reconstruction
Intervention type(s): Procedure
Intervention description(s): After radical gastrectomy, the gastrointestinal tract was reconstructed by Roux-en-Y gastrojejunostomy or esophagojejunostomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis
Other intervention name(s): modified Roux-en Y
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type II diabetes; Gastric cancer; Long limb Roux-en Y
Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine
Condition: Meningitis
MeSH terms: Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this observer-blind study is to evaluate the safety, reactogenicity and
      immunogenicity of Meninggococcal (A,C,Y and W135) Conjugate Vaccine in 2 months to 6
      years-old children.
    


Intervention name(s): MCV-ACYW135 Vaccine Group; MPV-ACYW135 Vaccine Group; MPV-A Vaccine Group; MCV-AC Vaccine Group; Hib Vaccine Group
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5ml, intramuscular; 0.5ml, intramuscular; 0.5ml, intramuscular; 0.5ml, intramuscular; 0.5ml, intramuscular
Other intervention name(s): Meningococcal ( A, C, Y and W 135) conjugate vaccine; Group A, C, Y and W-135 Meningococcal Polysaccharide Vaccine; Group A Meningococcal Polysaccharide vaccine; Group A and C Meningococcal conjugate vaccine; Haemophilus Influenzae Type b Conjugate Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Immunogenicity, Safety, Meningococcal Conjugate Vaccine
Ultrasound Guided Supraclavicular Nerve Block
Condition: Local Anesthetic
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will test the hypothesis that sequential injection of 1.5% mepivacaine followed 90
      seconds later by 0.5% ropivacaine in ultrasound guided supraclavicular block provides a
      quicker onset and a longer duration of analgesia than an equi-dose mixture of the two local
      anesthetics.
    

Detailed description: 
      Patients will be randomized into one of two groups, Group M: Ropivacaine and Mepivacaine -
      subject will receive two injections before surgery begins. These two injections will consist
      of the mixture of mepivacaine (15 ml) and ropivacaine (15 ml).

      Group S: Mepivacaine followed by Ropivacaine. Subjects will receive two injections before
      surgery begins. One injection will contain mepivacaine (15 ml) and the other will contain
      ropivacaine (15 ml).

      On the first, second, and third mornings after surgery,subjects will be asked to rate their
      pain on a scale of 1 to 10. If the subject is discharged from the hospital, a telephone call
      will be made to the subject's home to collect this information.
    

Intervention name(s): Ropivacaine; Mepivacaine
Intervention type(s): Drug; Drug
Intervention description(s): ropivacaine (15 ml).; One syringe will contain mepivacaine (15 ml)
Intervention MeSH terms: Ropivacaine; Mepivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: surgery for arm hand or elbow; mepivacaine; ropivacaine; hand surgery; elbow surgery; forearm surgery
Study of Axillary Skin Temperature as a Marker of Ovulation
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      Infertility is the most common reason women (aged 20-45yrs)see their GP, affecting 1 in 7
      couples. Measuring basal body temperature is a technique that has been used since the 1930's
      to attempt to predict ovulation. Current NICE guidelines don't recommend the use of BBT
      charts to predict ovulation, as it has not been established to reliably confirm ovulation.

      The DuoFertility sensor a CE marked Class la device provides a continuous accurate measure of
      axilla temperature whilst worn under the arm.

      The investigators plan to compare the temperature measurements of the DuoFertility sensor
      with the gold standard transvaginal ultrasound scan obtained during 10 infertile women's
      menstrual cycles, up to 10 cycles per women.

      The investigators aim to investigate if continuous axillary skin temperature measurement
      obtained from the DuoFertility sensor, provides comparable results for identifying the
      occurrence of ovulation as the gold standard transvaginal ultrasound scan.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infertile females of child bearing age with regular menstrual cycles trying to get pregnant
Internet-delivered Psychodynamic Therapy for Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The overall aim of this study is to develop and test a psychodynamic Internet-delivered
      psychological treatment for patients with mild to moderate major depression and compare its
      efficacy to an active control group.
    


Intervention name(s): Internet-delivered psychodynamic therapy for depression; Internet-delivered therapist support
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This intervention contains 9 text-based self-help modules. These modules contain material inspired by psychoanalytic theory about identifying reoccurring patterns in life among other things. In addition to the self-help modules, 10-15 minutes of therapist contact is given every week. In total, the intervention will last for 10 weeks.; This intervention contains 1 text-based self-help module, which is mainly based on information on depression. In addition to this text, the participants in this group gets 10-15 minutes of therapist contact every week. In the conversation with the therapist, the participant informs the therapist about the activities during the week. This intervention is considered to be a form of support. In total, the intervention will last for 10 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I Clinical Study of E7389
Condition: Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine the dose limiting toxicity and maximum
      tolerated dose of E7389 in patients with solid tumors. The secondary objectives are to
      investigate the pharmacokinetics, safety, estimated recommended dose, and anti-tumor effects
      (in evaluable cases) of E7389 in patients with solid tumors.
    


Intervention name(s): E7389
Intervention type(s): Drug
Intervention description(s): E7389 will be administered intravenously on Days 1 and 8 of a 21 day cycle. The initial dose level will be 0.7 mg/m2, with planned dose levels of 1.0, 1.4, 2.0 mg/m2.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; Tumors; Phase I; E7389