bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Peer Support and Yoga Music on T2DM With Depression and Sleep Disorders
Condition: Type 2 Diabetes
MeSH terms: Sleep Wake Disorders; Parasomnias
Study type: Interventional

Summary: 
      40 patients with Type 2 Diabetes Mellitus who also have sleep disorders and mild depression
      in the community will be recruited and stochastically divided into the intervention group and
      the control group. Both groups will take the same group education courses including DSME
      (Diabetes Self-management Education), psychological support, improvement in sleep. Patients
      in the intervention group will receive peer support and yoga music therapy before bed. The
      observation period will last for 6 months so as to evaluate the benefits of peer support and
      yoga music therapy in sleep quality improvement and glycemic control of type 2 diabetic
      patients with sleep disorders and mild depression.
    

Detailed description: 
      Research Method:

      This study is an open- label controlled randomized cluster trial with the sample size
      estimated by the improvement of Pittsburgh Sleep Quality Index（PSQI） score. 40 eligible and
      voluntary Type 2 diabetic patients will be recruited among the patients with health records
      in the community. Baseline assessment such as demography, sleep quality, depression, physical
      exam and biochemical index will be performed on the patients who will have signed the
      informed consents.

      The study will use the method of randomized to classify the enrolled units into 2 groups,
      each group has 20 people. Both groups will receive regular diabetes medication and group
      education courses including Diabetes Self-management Education(DSME), psychological support,
      improvement in sleep. The intervention group will be under the guidance of two well-trained
      peer supporters to carry out group activities. Each supporter will be in charge of 10-15
      patients. Starting with peer support therapy in the first three months, the intervention
      group will then take Yoga music therapy before bed for another three months and be given
      support and guidance by the peer supporters.

      Compare the baselines and variations of two group's sleep, depression, blood sugar and
      related biochemical indicators, and self-management, life quality, medication and other
      aspects at the third month and sixth month. The final evaluation will show the effect and
      related influencing factors of peer support and yoga music therapy in helping Type 2 diabetic
      patients who have sleep disorders and mild depression to improve their sleep quality.
    

Intervention name(s): peer support and yoga music therapy
Intervention type(s): Behavioral
Intervention description(s): Patients in the intervention group will receive peer support and yoga music therapy before bed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
The Effect of Consumption of Almonds and Snack Mix Daily for 6 Months on Cognitive Function in Older Adults
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      Cognitive impairment is also a major risk factor for development of dementia later in life.
      Findings from recent studies suggest that the there are many nutrients contained in foods
      that may be important in cognitive function in the elderly. This study evaluates long-term
      intervention with almonds and snack mix as a treatment strategy for age-related cognitive
      impairment which could possibly prevent the onset of dementia.

      The proposed study is designed as a randomized, placebo controlled trial that tests the
      effects of 6 month supplementation with 1.5 or 3 ounces of almonds or 3 ounces of shortbread
      containing coconut oil on cognitive function in older adults. Secondary outcomes include
      plasma biomarkers of oxidative stress and inflammation.
    

Detailed description: 
      The study is designed as a controlled trial that tests the effects of 6 month supplementation
      with 1.5 or 3 ounces of almonds or 3 ounces of snack mix a day on cognitive function in older
      adults. Subjects will be randomly assigned to one of the three groups. Secondary outcomes
      include plasma biomarkers of oxidative stress and inflammation. Participants will be
      recruited from community-dwelling men and women aged greater than of equal to 50 yr and less
      than or equal to 75 years and potential participants will be screened to meet cognitive and
      functional criteria. Participants will be pre-screened by telephone; those who appear to meet
      criteria will undergo further screening.
    

Intervention name(s): snack mix; almonds, 1.5 oz; almonds, 3 oz
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): commercial cereal mix with bits of beef jerky and coconut; almonds, 1.5 oz/day; almonds, 3.0 oz/day
Other intervention name(s): almonds, 3.0 oz
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: almonds; cereal snack
Hormonal Stimulation of Spermatogenesis
Condition: Azoospermia, Nonobstructive
MeSH terms: Azoospermia
Study type: Interventional
Phase: Phase 1

Summary: 
      Urologists and reproductive specialists are often challenged when facing patients with severe
      male infertility scenarios. In particular, the treatment of men with NOA demands a deeper
      insight. In such cases, .
    

Detailed description: 
      The hormonal stimulation of spermatogenesis is still being explored. Thus, there is still
      little knowledge regarding the type of patient who might benefit from medical treatment, the
      optimal medication,

      the regimen, and the duration of treatment. In male infertility, the induction for treatment
      with follicle stimulating hormone (FSH) in the induction and maintenance of spermatogenesis
      in patient with hypogonadotopic hypogonaism. As these patients are normally azoospermic
      without gonadotropin stimulation and during testosterone therapy

      The presence of high numbers of progressively motile and normally formed sperms in the
      ejaculate during exogenous gonadotropin therapy might result in the desired clinical
      pregnancy for many infertile couples on an experimental basis and in some places already in
      clinical routine. FSH preparation are also used for treatment of normogonadotopic infertile
      men with idiopathic impairment of spermatogemesis.

      Pulstile GnRH or exogenous gonadotropins are usually used to induce spermatogenesis and
      promote testicular enlargement .The regimen for gonadotropin replacement includes an initial
      use of human chorionic gonadotropin (HCG) for 6 to 12 months and then addition of FSH or
      human menopausal gonadotropins (HMG) until pregnancy
    

Intervention name(s): Beta-hCG
Intervention type(s): Drug
Intervention description(s): Treatment of spermatogenesis
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: to evaluate the effect of hormonal stimulation for patients with non-obstructive azoospermia
Masking: Single (Participant)
Primary purpose: Treatment
A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis (RA)
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the efficacy of Biologics + Methotrexate with
      Biologics + Tacrolimus measured by the disease activity score 28 (DAS28) erythrocyte
      sedimentation rate (ESR) and the American College of Rheumatology (ACR) scores. The study
      will also assess the safety of the combinations.
    

Detailed description: 
      This study will include 4-weeks screening and a 12-week open-label treatment period.The
      participants in this study will visit the center five (5) times over the study period.
    

Intervention name(s): tacrolimus; methotrexate; adalimumab; tocilizumab; abatacept
Intervention type(s): Drug; Drug; Biological; Biological; Biological
Intervention description(s): Administered orally; Administered orally; Administered as subcutaneous injection; Administered by intravenous injection; Administered by intravenous injection
Other intervention name(s): FK506; Prograf
Intervention MeSH terms: Adalimumab; Methotrexate; Abatacept; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tacrolimus; abatacept; Prograf; adalimumab; methotrexate; tocilizumab; FK506
Study of Home Full Blood Count (FBC) Telemonitoring Device for Chemotherapy Patient
Condition: Cancer
Study type: Interventional

Summary: 
      The Zodiac, a Philips healthcare telemonitoring system has been devised to allow cancer
      patients receiving chemotherapy to test their blood count at home. It is anticipated that the
      system will allow patients and clinicians to reduce the toxic effects of chemotherapy by
      early diagnosis of neutropenia, anaemia and any associated complications of chemotherapy. It
      is also anticipated that the system will also allow clinicians to better manage the
      scheduling of chemotherapy regimes.
    

Detailed description: 
      Philips Healthcare has devised a new home full blood count (FBC) home telemonitoring system
      which will allow cancer patients receiving chemotherapy to test their blood count at home
      (haemoglobin, haematocrit, white cell count and neutrophil count). The system will also allow
      patients to record their temperature and symptoms. The Philips home telemonitoring system is
      called the Zodiac and consists of a telecommunications hub connected to a haematology
      analyser. The Hub connects to medical device software running on a remote server which
      controls the flow of information between the Hub and the clinician. This is designed to
      enable the patient to self test their full blood count in their home and transmit the data
      remotely to a clinician for review. In addition to testing their full blood count, the
      patients can input their temperature and any symptoms they have onto the device. The
      clinician will then be able to send appropriate instructions back to the patient. The Philips
      Zodiac system can also send a preprogrammed automated message based on the results of
      testing.
    

Intervention name(s): Home Telemonitoring System (The Zodiac, Philips Health care)
Intervention type(s): Device
Intervention description(s): Full blood count (FBC) home tele-monitoring system which will allow cancer patients receiving chemotherapy to test their blood count at home (haemoglobin, haematocrit, white cell count and neutrophil count).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Chemotherapy use; Home Monitoring
Efficacy Study of Liraglutide vs.Sitagliptin vs. Glargine on Liver Fat in T2DM Subjects
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to explore the effectiveness of liraglutide combined with metformin
      in non-alcoholic fatty-liver disease patients with type 2 diabetes mellitus (T2DM) compared
      to sitagliptin and insulin glargine in combination with metformin.
    

Detailed description: 
      This is a 26-week, randomized, open-label, active controlled, parallel group, multi-centre
      trial.To compare the change of intrahepatic lipids (IHL) as measured by magnetic resonance
      spectroscopy(MRS) or MRI estimated proton density fat fraction (MRI-PDFF) as measured by MRI
      IDEAL IQ (Iterative Decomposition of water andfat with Echo Asymmetryand Least-squares
      estimation) in type 2 diabetic patients with non-alcoholic fatty-liver disease after a
      26-week treatment of liraglutide, sitagliptin or insulin glargine per day combined with
      metformin.The primary endpoint will be defined by intrahepatic lipids (IHL) as measured by
      magnetic resonance spectroscopy (MRS) or MRI-PDFF as measured by MRI IDEAL IQ.
    

Intervention name(s): Liraglutide combined with metformin; Insulin glargine combined with metformin; Sitagliptin combined with metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Liraglutide, 0.6mg per day for the first week, and will be increased to 1.2mg per day for the second week, and finally 1.8mg per day since the third week; The initial dose will be 0.2 unit/kg/d; The dose throughout the study will be 100mg per day.
Other intervention name(s): Victoza®, Novo Nordisk; Lantus®, Sanofi; Januvia®, Merck & Co. Inc.
Intervention MeSH terms: Metformin; Insulin Glargine; Sitagliptin Phosphate; Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-alcoholic fatty liver disease; Glucagon-like peptide-1 receptor agonists; Diabetes mellitus, type 2
Multiple Ascending Dose Study to Evaluate the Safety, Tolerability of DC371739 Treatment in Hypercholesterolemic
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of
      DC739 after multiple-dose oral administration, to explore the clinical effective dose, and to
      initially explore the efficacy and safety in hypercholesterolemia subjects.
    

Detailed description: 
      Totally about 30-50 qualified subjects were assigned to one of the following dose
      groups：20mg, 40mg, 60mg, 80mg, 120 mg (60mg and 120mg is the optional dose group). Each of
      the dose groups will include 10 subjects (8 for DC739 and 2 for placebo).

      Subjects will be admitted for treatment on day -1 and receive the first dose of study drug or
      placebo on day 1 and then treat for 28 days. Subjects from different dose groups were
      enrolled in turn, the next dose group is conducted on the premise that the D15 safety
      evaluation was completed after the administration of the previous dose group with the result
      was tolerance.

      Blood samples will be collected on day 1 for 48 hours and day 28 for 72 hours after
      administration for pharmacokinetic data analysis. Blood lipid will be collected for
      effectiveness evaluation. PCSK9 and ANGPTL3, Urine and feces were collected for explore
      analysis.
    

Intervention name(s): DC371739 Tablets; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants received one of 5 dose levels of DC371739 administered as single oral doses.; Placebo orally administered as comparison
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are assigned to one of 5 groups in parallel for the duration of the study
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hypercholesterolemia; Pharmacokinetics; Pharmacodynamics
Online Counseling to Enable Lifestyle-focused Obesity Treatment in Primary Care
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      With over half of the US population currently overweight and 31% of adults now obese, the
      primary care setting may represent an important source of weight-loss support, in the
      interest of cardiovascular prevention. Yet, although the US Preventive Services task force
      recommends that physicians screen all adult patients for obesity and offer intensive
      counseling and behavioral interventions to promote sustained weight loss for obese adults,
      the recommendation has not been widely implemented. The Internet may help overcome many of
      the barriers that have prevented intensive obesity counseling in the clinical setting. The
      aim of this study is to examine whether Internet-based interventions for developing healthier
      lifestyles can improve preventive health care in a cost-effective manner.
    

Detailed description: 
      The study, Online counseling to enable lifestyle-focused obesity treatment in primary care,
      aims to translate an evidence-based lifestyle intervention into the primary care setting,
      using information technology to enable clinical lifestyle counseling. While the US Preventive
      Services Task Force (USPSTF) recommends that clinicians screen all adult patients for obesity
      and offer intensive counseling and behavioral interventions to promote sustained weight loss
      for obese adults, multiple barriers to intensive lifestyle counseling exist and the
      recommendation has not been widely implemented. By requiring physician referral, augmenting
      the health care team's access to behavioral expertise, and encouraging physician feedback to
      participating patients, we aim to integrate lifestyle issues into routine preventive
      medicine. We will examine change in weight, waist circumference, physical activity, quality
      of life, and will calculate intervention cost-effectiveness. We will ensure sustainability by
      using recruitment and adherence strategies that can be replicated in routine practice, and
      counseling staff who are representative of the educators employed in primary care practice.
      If an online strategy is effective, the extensive network of the University of Pittsburgh
      Medical Center Health System provides excellent infrastructure for supporting dissemination
      in the region. As such, this study may facilitate wide-spread adoption of current
      evidence-based preventive medicine guidelines recommending incorporation of intensive
      lifestyle interventions into primary care practice.
    

Intervention name(s): VLM-S; VLM-M; OGR
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Online program for weight loss - standard; Online program for weight loss - modulated; Online program for weight loss - resources
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Internet
Safety and Pharmacokinetics of BIRB 796 BS Tablets Administered Twice Daily Orally to Healthy Human Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the safety and pharmacokinetics of BIRB 796 BS tablets administered as
      multiple daily doses at various dose levels
    


Intervention name(s): BIBR 796 BS; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Treatment of Ilioinguinal Entrapment Syndrome - an Often Overlooked Cause of Chronic Pelvic Pain
Condition: Chronic Pelvic Pain
MeSH terms: Pelvic Pain
Study type: Interventional

Summary: 
      Neuralgic pain caused by entrapment of peripheral nerves is an often overlooked cause of
      chronic pelvic pain. The objective of the present study was to assess pain and quality of
      life in women with pain caused by entrapment of the ilioinguinal nerve, iatrogenic after
      surgery but also found without previous surgery. In a controlled prospective cross-over study
      19 women were randomized either to medical treatment or to resection of the nerve.
      Statistically significant improvements were found after surgical resection.
    


Intervention name(s): Amitryptiline, gabapentin; Resection of the ilioinguinal nerve
Intervention type(s): Drug; Procedure
Intervention description(s): For amitryptiline starting dose 20-30 mg at night, increasing until clinical effect. For gabapentin was the initial dose 300 mg tid with rapid increases up to 800 mg tid.; In general anaesthesia the nerve was identified and resected as central as possible
Other intervention name(s): Amitryptiline - Saroten; Gabapentin - Neurontin
Intervention MeSH terms: Gabapentin; Amitriptyline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic pelvic pain; ilioinguinal nerve entrapment; randomized study; Chronic pelvic pain in women
A 12-week, Multicenter, Safety and Dose-ranging Study of 3 Oral Doses of TCH346 in Patients With Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is the first to be performed in Amyotrophic Lateral Sclerosis (ALS) patients with
      the novel compound TCH346. Its purpose is to evaluate the safety and clinical effects of 3
      dose levels of TCH 346 compared to placebo in patients with a clinical diagnosis of
      laboratory-supported probable, probable or definite ALS. The study will require patients to
      visit the study center a total of at least 7 times over the course of up to 14 weeks. The
      study consists of 2 phases: A screening phase (up to 2 weeks) when patients will be evaluated
      for eligibility to participate in the study, and a double-blind treatment phase (12 weeks)
      when patients will receive daily doses of either TCH346 or placebo and will be evaluated for
      clinical effects. In addition, patients eligible to participate in this study will be
      required to have 3 magnetic resonance spectroscopic (MRS) scans. The MRS is a non-invasive,
      painless, "brain scan". The MRS will require traveling to a designated center in Montreal,
      Canada, which is very experienced in performing such MRS scans in ALS patients.
    


Intervention name(s): TCH346
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: (ALS)
Prevenar (13v) Infant Drug Use Investigation
Condition: Infants
Study type: Observational

Summary: 
      The purpose of this study is to investigate post marketing use and safety of Prevnar ( 13v)
      in infants vaccinated for the first time at the age of 2 months, inclusive, to 7 months,
      exclusive.
    

Detailed description: 
      The investigation will be conducted using the continuous investigation method, with which a
      satisfying registration conditions will be continuously registered until the number of
      contracted cases is reached.
    

Intervention name(s): Prevenar (13v)
Intervention type(s): Drug
Intervention description(s): Prevenar (13v)
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Vaccinees who meet all of the following conditions at the time of the first vaccination
        among infants who use Prevenar 13 in accordance with the indication, and dosage and
        administration of the vaccine will be included in the investigation.