bioihbjkbjnl/mcl2 huggingface dataset:
Change in Skin Surface Temperature at the Knee Area on Both Sides When Using Mild Moxibustion Manipulation at Mingmen Acupoint With Moxa Stick
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Moxibustion plays an important role in Traditional Medicine treatments, which treats and
      prevents diseases by burning a herb preparation containing Moxa (Artemisia vulgaris, Mugwort)
      to stimulate the meridians of human body. Moxibustion is considered a safe and effective
      traditional therapy. Mild moxibustion is a kind of therapeutic method which characterized by
      wide indications, simple manipulation and comfortable feeling, is commonly used in clinical
      treatment. Mingmen acupoint located on the midline of the lower back, in the depression below
      the spinous process of the 2nd lumbar vertebra (L2). Its indications include Yang-deficiency
      syndrome, Cold-Stagnation syndrome, Cold Excessive syndrome,... and it is closely related to
      the knee area through the path of Thoroughfare Vessel (one of the Eight Extraordinary
      Vessels). In our study, we investigate the change in skin surface temperature at the knee
      area on both sides when using mild moxibustion manipulation at Mingmen acupoint with moxa
      stick in healthy volunteers.
    

Detailed description: 
      Participants and Methods: A randomized controlled trial is conducted by comparing the change
      in skin surface temperature before and after using mild moxibustion manipulation at the
      research acupoint (Mingmen (GV-4) acupoint) or the control acupoint (the left side Pishu
      (BL-20) acupoint) in healthy volunteers. A total of 38 participants will undergo 2 trial
      phases, corresponding to 2 times of moxibustion in 8 days, each time is 7 days apart. In the
      first trial phase: participants received moxibustion at left side Pishu (BL-20) acupoint. In
      the second trial phase: participants received moxibustion at Mingmen (GV-4) acupoint. The
      primary outcome was the change in skin surface temperature at the local stimulated area and
      the knee area on both sides when using mild moxibustion manipulation at Mingmen acupoint.
      This trial will be performed as a pilot study.
    

Intervention name(s): Mild moxibustion with moxa stick
Intervention type(s): Procedure
Intervention description(s): To conduct this intervention, we used moxa sticks which were 1.5 cm in diameter, 13 cm long, and weighed 12 gram to perform mild moxibustion manipulation at the control acupoint (the left side Pishu acupoint) or Mingmen acupoint in 2 trial phases. The main ingredient of the moxa was dried mugwort leaf, produced in Vietnam. All moxa materials were obtained from the Sai Gon TCS Co., Ho Chi Minh City, Vietnam.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: A pilot study
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Moxibustion; Skin surface temperature
Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Erythropoietic Protoporphyria
Condition: Erythropoietic Protoporphyria (EPP)
MeSH terms: Protoporphyria, Erythropoietic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the efficacy and safety of MT-7117 on sunlight
      exposure duration without symptoms and tolerance in subjects with EPP.
    

Detailed description: 
      This is a Phase 2, randomized, double-blind, placebo controlled study to assess the efficacy,
      tolerability, and safety of MT-7117 in subjects with EPP. The study consists of a 2 week
      screening period, a 16 week double-blind treatment period, and a 6 week follow-up period at
      Week 22. The total participation period is approximately 24 weeks.
    

Intervention name(s): MT-7117 low dose; MT-7117 high dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): MT-7117 low dose QD, oral, 16 weeks; MT-7117 high dose QD, oral, 16 weeks; Placebo QD, oral, 16 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation Of Acceptability And Satisfaction Of Hemophilia Patients Treated With FusENGO
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Observational

Summary: 
      This study aims to investigate prospectively throughout a period of 3- 6 months and not to
      exceed 12 months (according to local therapeutic plans) patients experiences of treatment
      with Factor VIII in the new device named FuseNGO, a new delivery system for Factor VIII
      compared to their previous delivery system.
    


Intervention name(s): Refacto FusENGO
Intervention type(s): Device
Intervention description(s): Dosage will be chosen by PI based on patient condition.
Intervention MeSH terms: Factor VIII
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Approximately 200 patients with Hemophilia A (all severity levels) will be enrolled in
        approximately 20 centers in Italy.
Early Discharged Lumbar Spine Fusion Reduced Postoperative Readmissions: A Follow-up Study in a National Cohort
Condition: Lumbar Spinal Fusion; Early Discharge; Readmission
Study type: Observational

Summary: 
      This study undertake to determine the effects of ED on readmissions and reoperations in
      lumbar fusion. The study enrolled patients who underwent lumbar fusion surgery at age 50-70
      years from a national database, and grouped them into an ED group or a comparison group. All
      patients were then followed-up for 180 days after the indexed surgery of lumbar fusion.
    

Detailed description: 
      Surgery for lumbar fusion is one of the most commonly performed spinal arthrodesis procedures
      worldwide. In recent years, there has been the emerging popularity of strategies aimed at
      early discharge (ED) in such a field of spinal surgery. However, more data are required to
      corroborate the adaptation of ED in spinal surgery. The benefits of ED in lumbar fusion have
      not yet been validated by large cohort studies. This study undertake to determine the effects
      of ED on readmissions and reoperations in lumbar fusion.

      This population-based retrospective cohort study used admission records of Taiwan's National
      Health Insurance Research Database (NHIRD). The NHIRD comprehensively contains de-identified
      claim data of Taiwan's National Health Insurance (NHI) program which covers 99% of the
      Taiwanese population and contracts with 97% of the providers of healthcare services in
      Taiwan. In order to protect privacy, the National Health Research Institute (NHRI)
      re-compiled, validated and de-identified the medical claims and finally made the data
      publicly available for medical researchers in Taiwan. In the admission database, the
      investigators are able to trace comprehensive information on the insured subjects, including
      gender, date of birth, dates of clinical visits and hospitalization, the International
      Classification of Diseases (Ninth Revision) Clinical Modification (ICD-9-CM) codes of
      diagnoses, ICD codes of surgical procedures, etc.
    

Intervention name(s): Rates of readmission and reoperation
Intervention type(s): Behavioral
Intervention description(s): All patients were then followed-up for 180 days after the indexed surgery of lumbar fusion. All-causes of re-hospitalization and re-operations for lumbar spine fusion, were analyzed at 30, 60 and 180 days for comparison between the ED group and the comparison group.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent lumbar spinal fusion surgery between July 2011 and June 2013 were
        identified and extracted in the NHIRD.
Evaluation of the Muscle Strength and Motor Ability in Children With Spinal Muscle Atrophy(SMA) Treated With Valproic Acid
Condition: Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Study type: Observational

Summary: 
      The purpose of this study is to determine if the treatment with valproic acid can increase
      the muscle strength and motor ability of children with spinal muscular atrophy.
    

Detailed description: 
      Spinal muscular atrophy (SMA) is an autosomal recessive disorder that affects the motoneurons
      of the spinal anterior corn, resulting in hypotonia and muscle weakness. The knowledge about
      its molecular mechanism has led to clinical tests with drugs that increase survival motor
      neuron (SMN) protein level. The valproic acid (VA) that acts as a histone deacetylase
      inhibitor activates the SMN2 gene increasing the protein level. Methods: Twenty-two patients
      with type II and III SMA, aged between 2 and 18 years old, were treated with VA and were
      evaluated five times along a period of one year using the Manual Muscle Test (Medical
      Research Council scale-MRC), the Hammersmith Motor Ability Score, and the Barthel Index. The
      first evaluation was coincident with the introduction of VA. Results: After 12 months of
      therapy, the patients did not gain muscle strength but their motor ability has improved.
      Children younger than 6 years of age had a higher pronounced gain in motor ability.
      Conclusion: treatment of SMA patients with VA is one alternative to alleviate the progression
      of the disease.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        22 children with spinal muscular atrophy disease
      
Keywords: Spinal Muscular atrophy; Valproic acid; HMAS; MRC scale
On Demand Contraception: Ulipristal Acetate Plus a COX-2 Inhibitor at Peak Fertility
Condition: Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an exploratory prospective study investigating if addition of a COX-2 inhibitor can
      increase efficacy of ulipristal in disrupting ovulation at peak fertility.
    

Detailed description: 
      This is an exploratory prospective study investigating if addition of a COX-2 inhibitor can
      increase efficacy of ulipristal in disrupting ovulation at peak fertility. We will compare
      the proportion of women with ovulatory disruption after taking the study medications with
      those women's own placebo cycles and also to previously established/published rates of
      ovulatory disruption of ulipristal alone.9 Given the established efficacy of ulipristal
      during the follicular time period as well as the theoretical mechanism of meloxicam to
      disrupt cumulus-oocyte expansion is a late step in ovulation, we hypothesize that this
      medication could emerge as the best candidate for an oral on-demand contraceptive option.
    

Intervention name(s): Ulipristal Acetate 30 MG Oral Tablet
Intervention type(s): Drug
Intervention description(s): Each study participant will receive one dose of the study medication (ulipristal acetate 30mg plus meloxicam 15mg) at peak fertility in the treatment cycle.
Other intervention name(s): Meloxicam
Intervention MeSH terms: Meloxicam; Ulipristal acetate
Intervention model: Single Group Assignment
Intervention model description: Single, open-label trial of one-time dosing of ulipristal acetate and meloxicam at a peak fertility time point.
Masking: None (Open Label)
Primary purpose: Prevention
Absorption and Digestion Kinetics of Human Metabolites
Condition: Postprandial Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The purpose of this pilot study is to evaluate the effects oral supplementation with four
      human metabolites (spermidine, nicotinamide, palmitoylethanolamide (PEA), and
      oleoylethanolamide(OEA)) at varying doses on the circulating blood levels of these
      metabolites as well as their immediate effects on plasma functionality and postprandial
      inflammation. 5 young healthy subjects will participate in a four armed study consisting of a
      Placebo arm and a Low, Medium, and High Dose arm. Subjects will be given a standardized
      breakfast along with supplementation with either an escalating dose (Low: 1x, Medium: 2x,
      High: 3x) of a combination of spermidine, nicotinamide, PEA and OEA or a placebo control and
      a time course of their blood plasma will be collected after supplementation. Plasma samples
      will be assessed for their concentration of spermidine, nicotinamide, PEA, and OEA as well as
      their experimental and clinical functionalities including their anti-inflammatory,
      antioxidant, and cholesterol efflux abilities on primary human macrophage.
    


Intervention name(s): Spermidine; Nicotinamide; PEA; OEA; Wheat Flour
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Spermidine in the form of a 0.1% spermidine wheat germ extract; Nicotinamide given as niacinamide; Palmitoylethanolamide given at 98% purity; Oleoylehtanolamide given at 90% purity; Wheat flour given as a placebo control
Other intervention name(s): Primeadine; Jarrow Niacinamide; Nootropics Depot PEA; Riduzone
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will take a supplement containing 4 metabolites at escalating doses compared with placebo after a standardized meal and their blood will be drawn at mutliple points throughout a postprandial time course to evaluate markers of inflammation, circulating levels of each metabolite, and plasma functionalities.
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluate Safety and Efficacy of an OC Preparation vs Placebo for 6 Treatment Cycles in Women With Moderate Acne.
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study were to evaluate the efficacy and safety of drospirenone 3
      mg/ethinyl estradiol 0.02 mg (DRSP/EE) in comparison with placebo in female subjects with
      moderate acne vulgaris during 6 treatment cycles.
    


Intervention name(s): YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The study medication was packaged in 28-tablet blister packs. Each subject kit contained 6 blister packs plus 1 reserve blister pack.Subjects randomly assigned to the active treatment group received 24 consecutive days of hormonally active tablets (3mgDRSP/0.02mgEE) followed by 4 consecutive days of inactive tablets. The treatment period was 6 cycles (28 tablets per cycle).; The subjects randomly assigned to the placebo group received 28 inert but identical-appearing, color-matched tablets. The treatment period was 6 cycles (28 tablets per cycle)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Moderate Acne Vulgaris; Acne
Safety and Tolerability of Anakinra in Combination With Riluzol in Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis (ALS)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Amyotrophic Lateral Sclerosis (ALS) is an adult neurodegenerative disease that is caused by a
      selective degeneration of the motor nerve cells in the cortex and myelon. As a result of
      motor neurodegeneration, a progredient paralysis of the extremities and of the speaking,
      swallowing, and breathing musculature develops. ALS leads to death by respiratory
      insufficiency in a mean course of 3-5 years. So far, Riluzole is the only approved
      neuroprotective medication which effects a slight lifespan prolongation of 1.5 - 2.5 months.
      Riluzole inhibits the presynaptic glutamate release and lowers the level of glutamate
      liberated by activated microglia.

      The researchers propose an investigational therapy of ALS with subcutaneous administration of
      100 mg of Anakinra. The neuronal inflammation is a crucial pathogenetic factor of the motor
      neuron degeneration. Inflammatory processes are detectable in sporadic ALS, in the
      autosomal-dominant form of ALS and in transgenic mouse model. The rationale of this clinical
      trial is based on the anti-inflammatory effect of Anakinra. One of the key mediators of
      inflammatory response is Interleukin-1. Anakinra is a recombinant produced Interleukin-1
      receptor antagonist. This gives Anakinra anti-inflammatory attributes that presumably reduce
      motor neuron degeneration and disease progression.
    

Detailed description: 
      Open Safety and Tolerability study to evaluate a subcutaneous application 100 mg of Anakinra
      in combination with Riluzol in Amyotrophic Lateral Sclerosis.
    

Intervention name(s): Anakinra
Intervention type(s): Drug
Intervention description(s): Open Safety and Tolerability study to evaluate a subcutaneous application 100 mg of Anakinra in combination with Riluzol in Amyotrophic Lateral Sclerosis.
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ALS; Anakinra; Kineret; Progressive Muscular Atrophy; PMA; Safety Trial; Tolerability Trial
Effect of Saccharomyces Cerevisiae on the Symptoms of Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The main purpose of this study is the effect of the probiotic yeast Saccharomyces cerevisiae
      CNCM I-3856 on abdominal pain or intestinal discomfort in patients presenting with the
      irritable bowel syndrome (IBS)
    


Intervention name(s): Saccharomyces cerevisiae CNCM I-3856; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 capsules/day during 12 weeks; Capsule with comparable organoleptic properties and weight than the experimental product.
2 capsules/day during 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
The Female Health Dietary Intervention Study
Condition: Polycystic Ovary Syndrome; Morbid Obesity
MeSH terms: Polycystic Ovary Syndrome; Obesity, Morbid; Syndrome
Study type: Interventional

Summary: 
      This study has two phases:

        1. In phase 1 of the study (8 weeks),the effect of two different low calorie diets on
           manifestations of PCOS, including risk factors for the metabolic syndrome and
           cardiovascular risk profile will be compared.

        2. In phase 2 the long term effect (next 44 weeks) on sustained weight-loss and the above
           mentioned parameters will be compared and evaluated.
    

Detailed description: 
      Weight loss is an important and effective treatment of morbidly obese women with PCOS.
      Effective weight reduction will improve manifestations of PCOS and risk factors for
      developing type 2 diabetes and coronary heart diseases. We compare the effect of two
      isocaloric low calorie diets (LCD), - one powder-based shake-diet and a fiber rich diet on
      the above mentioned parameters. In addition we want to compare the weight-maintenance effect
      the next 44 weeks of two different follow-up programs: A usual care- and a lifestyle-program.
    

Intervention name(s): Crispbread
Intervention type(s): Behavioral
Intervention description(s): 8 week low calorie diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Polycystic Ovary Syndrome; Morbid Obesity; Type 2 DM; Coronary heart disease
The Impact of Comprehensive Medication Management Services on Clinical Outcomes in Patients With Cardiovascular Diseases at Primary Care Level
Condition: Cardiovascular Diseases in Old Age
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Patients with established cardiovascular disease (CVD) often have multiple medications that
      increase the risk of prevalence of drug therapy problems (DTP), subsequently leading to
      unfavourable clinical and health outcomes. By providing Comprehensive Medication Management
      (CMM) services to patients within a healthcare system, pharmacists assess patients'
      medication-related needs, identify and prevent DTP, develop individualized care plan for each
      individual patient and evaluate and monitor outcomes. Thus, the CMM services delivered at the
      primary care level in collaboration with general practitioners and other healthcare providers
      could address this problem and by optimizing therapy improve patients' clinical outcomes and
      quality of life. Studies have shown that patients with chronic diseases have the greatest
      benefit from the CMM services. The aim of this study is to evaluate the impact of CMM
      services on clinical and humanistic outcomes in patients with established CVD. The study will
      employ prospective, longitudinal, pre- and postintervention study with a 1-year patient
      follow-up.
    


Intervention name(s): Comprehensive Medication Management services
Intervention type(s): Other
Intervention description(s): Comprehensive Medication Management services (CMM services) is an evidence-based and patient-centred service which involves an assessment of patient's medications to determine that each medication is appropriate, effective for the medical condition being treated, safe for the patient in the presence of other medications and co-morbidities, and that the patient is able and willing to take the medications as intended. As all patient care providers need a structured, rational thought process for sound clinical decision retrieval, the Pharmacotherapy Workup was developed and adopted as a systematic problem-solving process. This process represents the cognitive work taking place in the mind of the practitioner, and is used to identify, resolve, and prevent drug therapy problems (DTP), establish therapy goals, select interventions and evaluate outcomes.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: medication managements services, pharmaceutical care, primary care, elderly, control group, cardiovascular disease