bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Periodontal Treatment on Growth Differentiation Factor-15 Levels
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      In light of the controversy that are already approved but that however still exists regarding
      the efficacy and influence the management of Periodontitis, the aim of this study was to
      evaluates, at 6-months follow-up, the post-treatment clinical and serum parameters in
      patients with periodontitis, treated by either Full Mouth Scaling and Root Planing (FM-SRP)
      treatment versus conventional oral hygiene treatment on serum CRP and Growth differentiation
      factor-15 levels.
    

Detailed description: 
      This trial was conducted in accordance with the World Medical Association's Declaration of
      Helsinki of 1975, and reviewed in 2016. The local ethical committee approved the study
      protocol and each patient was carefully informed about the possible inherent risks of the
      study and provided their informed written consent.

      Subjects with a diagnosis of periodontitis were enrolled in this clinical trial. The
      inclusion criteria were: 1) good condition of general health, 2) a minimum of 2 teeth for
      each quadrant with a Pocket Depth (PD) ranging from 4-6 mm, 3) no involvement of the
      furcation, 4) a minimum of six teeth per quadrant, respectively. The exclusion criteria were:
      1) periodontal therapy during the last 12 months, 2) assumption of antibiotics during the
      last 6 months, 3) pregnancy, 4) any systemic condition which might affect the effects of the
      study treatment, 5) previous or current radiation or immunosuppressive therapies, 5) use of
      mouthwash containing antimicrobials during the previous 3 months, 6) no use of hormonal
      contraceptives, 7) medication by anti-inflammatory and immunosuppressive drugs, 8) previous
      history of hard-drinking, 9) smoking, 10) class II and III tooth mobility. Patients randomly
      undergo to full mouth SRP or Quadrant SRP
    

Intervention name(s): Full mouth Scaling and root planing; Quadrant Scaling and root planing
Intervention type(s): Other; Other
Intervention description(s): patients were treated with full mouth Scaling and root planing; patients were treated with quadrant Scaling and root planing
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Each selected patient underwent randomly, without anaesthesia, after recording periodontal parameters, the two following treatments: in one, maxillary quadrants were treated as conventional Quadrant Scaling and Root Planing (SRP) or Full-Mouth Scaling and Root Planing
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of a Biofeedback-assisted Meditation Program as a Stress Management Tool for Hospital Nurses
Condition: Stress
Study type: Interventional

Summary: 
      The purpose of this study is to assess a novel meditation program which is biofeedback
      reinforced (Healing Rhythms™) as a means to improving stress management in a population of
      nurses practicing in the hospital setting.
    

Detailed description: 
      Stress is a common problem with significant ramifications for health. This is especially true
      in the workplace and particularly true for nurses practicing in a hospital environment. A
      number of factors (e.g. an aging population, the obesity epidemic, patients presenting with
      multi-system diseases, etc.) have dramatically increased the demands on hospital nurses in
      the past decade. This increased stress has potential ramifications at a personal level (e.g.
      increased risk of ill health) as well as an institutional (e.g. higher staff turnover).
      Meditation has been shown to be an effective tool for stress management. A self-directed,
      computer-guided meditation training program that can be pursued independently may be
      particularly useful for hospital nurses where scheduling challenges may preclude the use of
      scheduled classes. Healing Rhythms™ is a computer program that teaches meditation and uses
      biofeedback (heart rate variability and galvanic skin response) to reinforce the training.
    

Intervention name(s): Healing Rhythms™ Meditation Program
Intervention type(s): Behavioral
Intervention description(s): The Healing Rhythms™ meditation program was chosen as the intervention for this study because it has a long history of use in the consumer market, it provides a dual-mode biofeedback which allows users to visually see their progress, and it provides an attractive and engaging user interface which is enjoyable to use. This is a critical factor as the research cited documents the importance of adherence in achieving optimal outcomes.
Other intervention name(s): Wild Devine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healing Rhythms™; Meditation; Biofeedback; Stress
Adding Phosphorus to Osteoporosis Drug Treatment
Condition: Osteoporosis; Osteopenia
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 2

Summary: 
      Osteoporosis causes bones to weaken and break more easily. Calcium and phosphorus are two
      minerals that are essential for normal bone formation. Unfortunately, calcium salts commonly
      prescribed in anti-osteoporosis treatment bind phosphorus from food and restrict phosphorus
      available for bone building. Teriparatide is a drug that reduces the risk of fractures by
      increasing bone thickness and strength. Vitamin D is also necessary for strong bones and
      teeth. The purpose of this study is to evaluate the bone-building effectiveness of two
      calcium supplements, one with a source of phosphorus and one without, in combination with
      teriparatide and vitamin D in women with osteoporosis.
    

Detailed description: 
      Osteoporosis is the most common type of bone disease. Calcium supplements normally used in
      anti-osteoporosis treatment are calcium salts of carbonate or citrate; however, these salts
      bind phosphorus from food in the intestine and restrict phosphorus available for bone
      building. This study will evaluate the efficacy of adding calcium phosphate to a regimen of
      teriparatide and vitamin D in increasing bone mineral density in women with osteoporosis. It
      is hypothesized that the group taking the phosphate-containing calcium supplement will have
      greater gains in bone mineral density (BMD) during the course of the study than the group not
      receiving phosphate.

      All participants will receive teriparatide and vitamin D during the course of the 12-month
      study. Participants will be randomly assigned to one of two groups. One group will receive
      calcium phosphate and the other will receive calcium carbonate. BMD will be measured at spine
      and hip at baseline and at 3, 6, and 12 months of treatment.
    

Intervention name(s): Calcium carbonate; Calcium Phosphate
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.; Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
Intervention MeSH terms: Calcium, Dietary; Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Bone Mineral Density; Calcium
Effect of Probiotic Lactobacillus Reuteri in the Treatment of Mucositis and Periimplantitis
Condition: Mucositis; Peri-implantitis
MeSH terms: Mucositis; Peri-Implantitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluate clinically and microbiologically the effect of the oral probiotic Lactobacillus
      reuteri Prodentis (PerioBalance®, Sunstar, Switzerland) on implants with mucositis or
      periimplantitis, as a coadjuvant treatment of mechanical therapy.
    

Detailed description: 
      A total of 44 patients, 22 with mucositis and 22 with periimplantitis, were randomly assigned
      to either the control or the test group, so that 11 patients received placebo and 11
      probiotic treatment. After the baseline clinical, radiological and microbiological
      examination, and once the study group was randomly assigned (probiotic or placebo),
      supragingival prophylaxis was performed in the mucositis group and subgingival mechanical
      therapy in the periimplantitis group. Then they get a container with 30 probiotic or placebo
      tablets and instructions on how and when to take them. At 30 and 90 days after beginning the
      treatment, a clinical, radiological and microbiological examination was performed.
    

Intervention name(s): Probiotic; Placebo Oral Tablet
Intervention type(s): Drug; Device
Intervention description(s): 30 probiotic tablets were given after the mechanical debridement of implants with mucositis and periimplantitis.; 30 placebo tablets were given after the mechanical debridement of implants with mucositis and periimplantitis.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized controlled, parallel design, triple-blind prospective clinical study with a follow-up of 3 months.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mucositis, periimplantitis, probiotic
A Pilot Study of a Dendritic Cell Vaccine in HIV-1 Infected Subjects
Condition: HIV-1 Infection; HIV Infections
MeSH terms: Infections; Communicable Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to find out whether an experimental autologous dendritic cell
      vaccine is safe, well tolerated, and whether it can strengthen the immune system's response
      to HIV.
    

Detailed description: 
      This is a randomized trial to evaluate whether mRNA-transfected dendritic cell vaccination is
      safe and immunogenic in HIV-infected participants who are on antiretroviral therapy.
    

Intervention name(s): mRNA-transfected autologous dendritic cells; autologous dendritic cells with no mRNA transfection
Intervention type(s): Biological; Biological
Intervention description(s): Injections will be administered intradermally at weeks 0, 2, 6 and 10.; Injections will be administered intradermally at weeks 0, 2, 6 and 10.
Other intervention name(s): Autologous dendritic cells not transfected with mRNA.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: HIV vaccine; Dendritic cells; treatment experienced
Cardiac Output Autonomic Stimulation Therapy for Heart Failure (COAST-HF) - Human NeuroCatheter Study
Condition: Cardiac Output, Low
MeSH terms: Heart Failure; Cardiac Output, Low
Study type: Interventional

Summary: 
      A single-center feasibility study in patients undergoing cardiac catheterization, to
      investigate the acute hemodynamic effects of transvenous cardiac autonomic nerve stimulation.
    

Detailed description: 
      A single-center feasibility study performed in patients undergoing a planned cardiac
      catheterization. This study investigated the feasibility of the NeuroTronik CANS Therapy™
      System to improve acute hemodynamics. Purpose-built stimulation catheters were percutaneously
      inserted into an upper venous structure near the heart via right femoral vein and or left
      subclavian vein access using standard introducers and techniques. Subjects were instrumented
      with left ventricular and femoral artery catheters for pressure measurement and stimulated
      for approximately 60 minutes. Baseline hemodynamic measures were collected before stimulation
      and compared to measured values during stimulation. Following completion of the protocol, all
      in-dwelling equipment and catheters were removed.
    

Intervention name(s): NeuroTronik CANS Therapy System
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Electrical Stimulation Therapy; Parasympathetic Nervous System; Sympathetic Fibers; Post Ganglionic; Congestive Heart Failure; Heart Failure
Comparison Between Lingual and Labial Fixed Orthodontic Appliances in the Treatment of Crowding Cases
Condition: Crowding
Study type: Interventional

Summary: 
      Patients who have moderate crowding that could be treated without extraction will be treated
      in this study using either lingual or labial fixed orthodontic appliances. All patients will
      receive a cone-beam computed tomography (CBCT) scan in two different times (T0: before
      treatment, T1: after treatment). The dentoalveolar changes will be assessed.
    

Detailed description: 
      Lingual orthodontic appliances provide an ultimate esthetic solution for patients who do not
      want visible orthodontic appliances. Recently, lingual orthodontic treatment outcomes have
      become similar and comparable to those produced with labial orthodontic treatment. However,
      placement of orthodontic brackets on the lingual surfaces of teeth causes changes in their
      morphology, which results in articulation problems, chewing difficulties, tongue irritation
      and other impairments. In this respect, the main difference between the labial and lingual
      techniques is the distance between the point of application of the force that is transmitted
      through the bracket and the centre of resistance of the tooth. Consequently, the displacement
      and stress induced in bone by these two techniques will also differ, and these need to be
      evaluated so that useful comparisons can be made between these two techniques. Patients who
      have moderate crowding that could be treated without extraction will be treated in this study
      using either lingual or labial fixed orthodontic appliances. All patients will receive a
      cone-beam computed tomography (CBCT) scan in two different times (T0: before treatment, T1:
      after treatment). The dentoalveolar changes will be assessed.
    

Intervention name(s): Lingual appliances; Labial appliances
Intervention type(s): Device; Device
Intervention description(s): Patients with moderate crowding will be treated without extraction using lingual appliances.; Patients with moderate crowding will be treated without extraction using labial appliances.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fixed appliances; labial appliances; lingual appliances
Intraarticular Leukocyte-rich and Leukocyte-poor PRP for Osteoarthritis of the Knee
Condition: Osteo Arthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To compare the efficacy of intraarticular knee injection between leukocyte-rich and
      leukocyte-poor platelet-rich plasma in knee osteoarthritis treatment
    

Detailed description: 
      Participants were randomized into 3 groups (leukocyte-rich platelet-rich plasma (LR-PRP),
      leukocyte-poor platelet-rich plasma (LP-PRP), and Corticosteroid (CS)). The primary outcome
      of this study is The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
      and was measured pre-treatment and post-treatment at follow-up at 1, 3, and 6 months
    

Intervention name(s): Leukocyte-rich platelet-rich plasma; Leukocyte-poor platelet-rich plasma; Corticosteroid
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intra-articular knee injection; Intra-articular knee injection; Intra-articular knee injection
Other intervention name(s): LRPRP; LPPRP; CS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: OA knee; PRP; Leukocyte concentration; Osteoarthritis Knee
Metformin and Folate in Pregnant Polycystic Ovary Syndrome(PCOS) Women
Condition: Pregnancy; Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      A more recent prospective nonrandomized placebo-controlled double-blind clinical study
      demonstrated that metformin exerts a slight but significant deleterious effect on serum
      homocysteine (Hcy) levels in patients with PCOS, and supplementation with folate is useful to
      increase the beneficial effect of metformin on the vascular endothelium.
    

Detailed description: 
      PCOS (cases) and non-PCOS (controls) pregnant women were enrolled. Cases will be randomized
      in four treatment groups: metformin plus placebo (group A1), metformin plus folic acid (group
      A2), placebo plus folic acid (group A3), placebo alone (group A4). Controls will not received
      any treatment (group B). Clinical and biochemical assessment (including serum markers of
      implantation), Doppler velocimetry of the uterine arteries, and trophoblastic invasion at
      histological and immunohistochemical evaluation.

      Changes in clinical and biochemical data under treatment, pattern of Doppler velocimetry at
      the uterine arteries, and trophoblastic invasion were evaluated.
    

Intervention name(s): metformin plus placebo; Metformin plus folic acid; placebo plus folic acid; placebo alone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): metformin 850 mg cp, 2 cps daily; metformin 850 mg cp, 2 cps daily plus folic acid 0.4 mg daily; Placebo 1 cp daily plus folic acid 0.4 mg daily; placebo cp, 2 cps daily
Intervention MeSH terms: Folic Acid; Vitamin B Complex; Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Folate; Metformin; PCOS; Pregnancy; Trophoblastic invasion; Uterine artery velocimetry
Thinking in Speech for Children With Autism
Condition: Autism Spectrum Disorder; Speech
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This study examines a cognitive therapy for autistic children, Thinking in Speech. Thinking
      in Speech helps children with autism independently cope with everyday events that cause
      stress, by developing their ability to use "inner speech".
    

Detailed description: 
      The purpose of this study is to examine the effectiveness of Thinking in Speech (TiS) in
      teaching children to identify when they are experiencing a problem and learn to ask for help
      appropriately.

      Participants. Participants will be 20 verbal children, aged 7-11, who have been diagnosed
      with autism or related neurocognitive disorders. Therapists will be experienced and certified
      speech-language pathologists (SLPs) who will be trained to use TiS For this grant,
      investigators will develop a standardized training program that can be administered to
      community SLPs. Training will consist of background reading and discussions, analysis of past
      therapy sessions, and practice sessions with individualized feedback provided by a trainer.
      Training will focus on developing the child's ability to ask for help. Asking for help
      requires a complex combinations of executive functions and being able to adopt the
      perspective of another person. Training sessions will be recorded for use in further training
      development and enhancements. A five-week training program is anticipated.

      Procedure: Both training and therapy will be delivered remotely. The therapists will plan to
      conduct sixteen 30-minute remote therapy sessions over 8 weeks - the actual time frame will
      depend on the health and scheduling demands of the therapists and children. All TiS sessions
      will be video-recorded. Children will be randomly assigned to either receive therapy
      immediately or to be placed on a 10-week wait-list after which they will receive therapy.
    

Intervention name(s): Thinking in Speech
Intervention type(s): Behavioral
Intervention description(s): Thinking in Speech is a therapy to help children with autism learn to cope with daily stressors and improve their communication.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: All participants will receive the Thinking in Speech Therapy
Masking: None (Open Label)
Primary purpose: Treatment
Acupuncture in the Regulation of Dai Meridian for the Metabolism of Visceral Adipose Tissue in Abdominal Obese Patients
Condition: Abdominal Obesity; Metabolic Syndrome
MeSH terms: Obesity; Metabolic Syndrome; Obesity, Abdominal
Study type: Interventional

Summary: 
      To evaluate the effectiveness of acupuncture therapy combined with healthy education for
      patients with abdominal obesity.
    

Detailed description: 
      This subject is a prospective, single-blind, parallel-group, randomized controlled clinical
      trial.120 patients with abdominal obesity are allocated into two groups with a ratio of
      2:1.Randomized series was generated by computer. The allocation was concealed. Patients in
      the intervention group are received acupuncture therapy and healthy education. Patients in
      the control group are only given healthy education. The treatment in both intervention group
      and control group lasts for 8 weeks. Comparison of two groups of patients with abdominal fat
      thickness, fasting serum visfatin concentration, simple anthropometric parameters (including
      body weight, body mass index, waist circumference, hip circumference, waist-to-hip radio,
      waist-to-height radio, the percentage of body fat), fasting blood glucose, fasting insulin,
      glycosylated hemoglobin, fasting blood lipid (total cholesterol, triglyceride, high density
      lipoprotein, low density lipoprotein), uric acid, blood pressure, insulin resistance level,
      and obesity related lifestyle survey.
    

Intervention name(s): Acupuncture; Healthy education
Intervention type(s): Other; Other
Intervention description(s): Acupuncture needles of 0.3mm in diameter and 100mm in length are inserted into gallbladder-meridian(GB)26 about 25-65mm deep by an angle of 15°, following the path of Dai Meridian (towards medial and downside) . The other acupoints are inserted with needles of 0.25-0.3mm in diameter and 25-40mm in length approximately 10-30mm deep, with an angle of 90°. Electro-acupuncture is applied to both sides of GB26 and stomach-meridian(ST)25: cathode is connected to GB26; anode to ST25. Dense-disperse wave pattern and a wave frequency of 2/100 Hertz is chosen. The intensity of the electro-acupuncture is adjusted on average 4-8 milliampere. The needles are subsequently retained for 20min. The results of the study are based on 8 weeks, each week consisting of 3 sessions.; Healthy knowledge lectures and issuing brochures are given. Education of patients for conditioning and changing bad habits, diet, quit smoking, limit alcohol consumption, salt restriction, appropriate increase in physical activity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment