bioihbjkbjnl/mcl2 huggingface dataset:
Diamel in the Treatment of Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy of Diamel administration in the treatment
      of Metabolic Syndrome. The duration of this double-blind placebo controlled phase 3 clinical
      trial will be 12 months.
    


Intervention name(s): Diamel; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Two Diamel tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 12 months, together with the standard treatment for metabolic syndrome consisting in appropriate diet according to patient's weight and physical activity, and appropriate hypertensive drugs (generally ACE inhibitors) for hypertension. Patient´s were also verbally encouraged to increase physical activity (to walk for 30-45 minutes a day 3-4 days a week).; Two Placebo tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 12 months, together with the standard treatment for metabolic syndrome consisting in appropriate diet according to patient's weight and physical activity, and appropriate hypertensive drugs (generally ACE inhibitors) for hypertension. Patient´s were also verbally encouraged to increase physical activity (to walk for 30-45 minutes a day 3-4 days a week).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dietary supplement; Diamel; Metabolic Syndrome
A Study Measuring Effect of LY2140023 (Pomaglumetad Methionil) on Electrocardiographs in Participants With Schizophrenia
Condition: Schizophrenic Disorders
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study determined if a single dose of LY2140023 (pomaglumetad methionil) affects the
      electrical activity in the heart in participants with schizophrenia. This study also helped
      determine how a single high dose of LY2140023 is tolerated by participants.
    

Detailed description: 
      The primary objective of this study was to determine that a single supratherapeutic dose of
      LY2140023 does not differ from placebo in the mean change from baseline in 12-lead
      electrocardiogram (ECG) QT interval measurements, such that the upper bound of the 2-sided
      90% confidence interval (CI) for the greatest time-matched mean effect is <10 ms in subjects
      with schizophrenia. The secondary objective was to further evaluate the tolerability of a
      supratherapeutic single dose of LY2140023 monohydrate.

      Male or female subjects diagnosed with schizophrenia and aged between 18 and 65 years,
      inclusive, who had not been hospitalized for psychiatric illness for at least 12 weeks prior
      to Day 1 of the lead-in period, and who had a Clinical Global Impression - Severity scale
      score of <4 were included in the study.
    

Intervention name(s): LY2140023; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally.; Administered orally.; Administered orally.
Other intervention name(s): pomaglumetad methionil; Avelox
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Effects of PGS in Infertile Female Patients With RPL
Condition: Infertility, Female; Abortion, Habitual
MeSH terms: Infertility; Infertility, Female; Abortion, Habitual
Study type: Interventional

Summary: 
      Recurrent pregnancy loss (RPL) is a multifactorial disorder which affects about 1% of all
      couples and challenges both patients and clinicians technically and emotionally. IVF clinics
      see higher prevalence of RPL, since many RPL patients are seeking for assist reproduction
      treatment with or without other infertile factors. Guidelines for evaluation and treatment of
      RPL patients include screening for uterine abnormalities, parental chromosomes, autoimmune
      antibodies and cure gynecological infections, but there are still half of RPL patients remain
      unexplained.

      The documented high incidence of chromosomal errors in first-trimester miscarriages and an
      increased rate of aneuploidy in patients with RPL has led to the theory that screening
      embryos before implantation for aneuploidy may decrease the risk of a subsequent loss and
      serve as a possible treatment. The technology, indications of use, and even terminology for
      genetic testing of embryos have greatly changed since the first PGD(pre-implantation genetic
      diagnosis) baby was born in 1990. The current best evidence shows blastocyst biopsy followed
      by new rapid comprehensive chromosome screening(termed pre-implantation chromosomal screening
      or comprehensive chromosome screening, PCS or CCS, or the investigators generally termed PGS)
      based on array-comprehensive genome hybridization(aCGH), single nucleotide polymorphism
      array(SNP-array) or next generation sequencing(NGS), to be the most powerful technology.
      However, for whom this PGS technique is most suitable to achieve improved clinical outcome
      have not yet been identified by well defined, ITT based research with carefully selected
      control and adequate sample size.

      The investigators research is to determine whether in vitro fertilization (IVF)/
      intracytoplasmic sperm injection (ICSI) combined with SNP-array based pre-implantation
      comprehensive chromosome screening (CCS) will improve the clinical outcome of infertile
      female patients with recurrent spontaneous abortion history.
    


Intervention name(s): IVF/ICSI; PGS; Without PGS
Intervention type(s): Procedure; Genetic; Other
Intervention description(s): In vitro fertilization or intracytoplasmic sperm injection.; Selection of embryos are based on SNP-array-based preimplantation genetic screening for the number of all chromosomes on the 5th day of IVF/ICSI.; Selection of embryos are based on morphology criteria on the 5th day of IVF/ICSI.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: In Vitro Fertilization; Intracytoplasmic Sperm Injections; Infertility, Female; Abortion, Habitual; recurrent pregnancy loss; comprehensive chromosome screening; preimplantation genetic screening; SNP array
A Study to Assess Any Potential Interaction Between Colesevelam and Ciclosporin in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess any potential interaction between colesevelam and
      ciclosporin in healthy volunteers.
    


Intervention name(s): Colesevelam hydrochloride film-coated tablets (Cholestagel)
Intervention type(s): Drug
Intervention MeSH terms: Colesevelam Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Familial Hypercholesterolemia
Application of Combined Lumbar Plexus and Sciatic Nerve Block
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The research is to study the effectiveness and safety of combined lumbar plexus and sciatic
      nerve block by the guide of peripheral nerve stimulator (PNS) in unilateral knee
      replacement.There have be some papers which supported that combined lumbar plexus and sciatic
      nerve block may be more suitable for the old men.
    


Intervention name(s): Nerve block; Combined spinal and epidural anesthesia; Ropivacaine; Bupivacaine
Intervention type(s): Procedure; Procedure; Drug; Drug
Intervention description(s): Patients in this group were assigned to receive lumbar plexus block and sciatic nerve block both using 0.33% ropivacaine 30ml guided by PNS; Combined spinal and epidural anesthesia were performed in patients of this group with 0.5% hyperbaric bupivacaine 8~10mg at L2-3 or L3-4.; Patients will be assigned to receive lumbar plexus block and sciatic nerve block both using 0.33% ropivacain 30ml guided by PNS.; Combined spinal and epidural anesthesia will be performed in patients with 0.5% hyperbaric bupivacaine 8~10mg.
Other intervention name(s): 0.33%Ropivacaine; 0.5%Bupivacaine
Intervention MeSH terms: Bupivacaine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: combined lumbar plexus and sciatic nerve block，; combined spinal and epidural anesthesia
Effects of Low Intensity, High Intensity Eccentric Resistance Training Associated With Blood Flow Restriction
Condition: Exercise
Study type: Interventional

Summary: 
      Introduction: studies on resistance training of low intensity associated with blood flow
      restriction in recent years, although there are still gaps that can be explored in relation
      to their physiological phenomena when associated with eccentric training. In this way, from
      there the exploration becomes relevant the investigation of eccentric training associated to
      an RFS. Objective: To analyze and compare the effects of a high intensity and low intensity
      intensive resistance training associated with an RFS (TREAI-RFS and TREBI-RFS) with a high
      intensity eccentric resistance training without RFS (TREAI) in knee extensors. Method: The
      study will consist of 45 male participants, allocated from a stratified randomization into
      three groups: TREAI (n = 15), TREAI-RFS (n = 15) and TREBI-RFS (n = 15). Participants
      underwent a training program with a minimum of 40% without RFS, 80% with RFS and 40% with CVS
      of CVIM, 3 times a week, and the outcomes of muscle strength, muscle structure, power test
      and Endothelial growth will be assessed one week before, the fourth week and one week after
      the end of the training program. In addition, clinical markers of perception and recovery
      effort are investigated before and after a session. The graph used is descriptive and
      descriptive, as it is used as a model of analysis of variance for the analysis of
      replications without a two-factor scheme, which provides detailed information on how the
      measures are repeated, neither. A whole statistical analysis can reach the level of
      significance of 5%.
    


Intervention name(s): High intensity eccentric training; High intensity eccentric training with BFR; Low intensity eccentric training with BFR; Low intensity eccentric training
Intervention type(s): Other; Other; Other; Other
Intervention description(s): High intensity eccentric training group with 80% of isometric peak torque.; Eccentric high intensity training group with 80% of isometric peak torque associated with blood flow restriction (40% of absolute occlusion pressure).; Low intensity eccentric training group with 40% of isometric peak torque associated with blood flow restriction (40% of absolute occlusion pressure).; Low intensity eccentric training group with 40% of isometric peak torque
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Eccentric Training; Resistance Training
Phase 2a, Exploratory Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of XPF-002 in Patients With Primary/Inherited Erythromelalgia
Condition: Primary Erythromelalgia; Inherited Erythromelalgia
MeSH terms: Erythromelalgia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Phase 2a single-center, randomized, double-blind, Placebo-controlled, parallel
      group study with XPF-002 applied twice daily over 14 or 21 days in patients with
      Primary/Inherited Erythromelalgia (IEM). The purpose of this study is to determine whether
      XPF-002 is safe and effective in the treatment of pain caused by IEM.
    

Detailed description: 
      Your role in the study would include:

        -  Travelling to the clinic (in Anniston, Alabama, USA) for 3 out-patient visits, each
           lasting approximately 1 day

        -  Travelling and staying in the clinic for 2 in-patient stays:

        -  For the first in-patient visit you will have to spend 8 days and 7 nights in the clinic

        -  For the second in-patient visit you will have to spend 2 days and 1 night in the clinic
           You can bring books, laptops and DVDs to the clinic.

      If you do not live within driving distance to the clinic you will need to stay in the local
      area (in Anniston, at a local hotel) for 1 to 2 weeks while you use the ointment, in addition
      to the in-patient portion of the study.
    

Intervention name(s): XPF-002; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days; XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IEM; EM; Erythromelalgia; Erythermalgia; Red neuralgia; Peripheral Vascular Disease; Vascular Disease; Cardiovascular Disease
Reconstruction of Jaw Bone Using Mesenchymal Stem Cells
Condition: Bone Atrophy
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      This pilot study is aimed to reconstruct atrophied posterior alveolar mandibular ridges using
      biomaterial and autologous bone marrow derived stem cells (BMMSC) and to insert an implant
      into the new bone in a prosthetically guided position.
    

Detailed description: 
      Eleven patients presenting with the need of an implant retained restoration in the posterior
      mandibula and an alveolar ridge of maximum 4.5 mm width.

      A clinical examination, x- rays and Cone Beam CT(CBCT) are accessed. A sample of the
      patients' bone marrow is extracted from the posterior alveolar ridge, immediately shipped to
      the collaborating good clinical practice (GCP) cell laboratory for cell expansion, and
      returned after 21 days. The stem cells mixed with Bi Calcium Phosphate (BCP) are then used to
      augment the alveolar ridge. The material is covered with a titanium reinforced membrane
      before closure of the site. After four to six months a bone biopsy is performed and implants
      are installed in the regenerated bone.

      The patient will be followed after 1, 2, 3, and 5 years where implant stability will be
      assessed. Furthermore the new formed bone will be clinically and radiologically assessed at
      the same time.
    

Intervention name(s): BCP with autologous mesenchymal stem cells (MSC).
Intervention type(s): Drug
Intervention description(s): Augmentation of narrow alveolar ridge with BCP and MSC
Other intervention name(s): MSC and BCP
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mesenchymal stem cells; bone augmentation; bone regeneration
Increasing Physical Activity in Persons With Depression
Condition: Depression; Physical Activity
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Pilot study to assess a multi-component intervention to increase physical activity in persons
      with depression.
    

Detailed description: 
      The research project is a pilot study to assess the effects of a multi-component intervention
      in increasing physical activity among persons with depression. Individuals meeting
      inclusion/exclusion criteria will be enrolled in the 12-week intervention. Intervention
      components will include self-monitoring, Active Living counseling, and facility access. Blood
      samples will be collected at baseline. Assessments (anxiety, stress, sleep) and sample
      collection will also occur at 2 time points during the intervention (Weeks 7 and 13). Changes
      in physical activity will be assessed using Fitbits to measure weekly minutes of
      moderate/vigorous activity.
    

Intervention name(s): Physical Activity
Intervention type(s): Behavioral
Intervention description(s): Self-monitoring: Subjects will be provided with a commercially available activity monitor (i.e., Fitbit) and instructed to wear the device daily.
Active Living counseling: The Active Living counseling program will consists of 12 weekly group educational sessions, facilitated by project interventionists. These sessions will involve discussion of topics related to increasing physical activity, including: identifying and overcoming barriers, setting goals, social support, and time management.
Facility Access: Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nuedexta for the Prevention and Modification of Disease Progression in Episodic Migraine
Condition: Episodic Migraine
MeSH terms: Migraine Disorders; Disease Progression
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and effectiveness of daily
      dextromethorphan/quinidine (Nuedexta) in reducing the frequency and progression of episodic
      migraine.
    

Detailed description: 
      This is a double-blind, placebo-controlled, randomized, multi-center study to be conducted at
      the Headache Care Center in Springfield, MO and two other clinics in the United States.
      Approximately 45 subjects, 18 to 65 years of age, with frequent episodic migraine (6-14 days
      per month), with (1.2) or without aura (1.1) as defined by ICHD-3beta, will enter a 1-month
      baseline period to confirm the migraine diagnosis, as well as establish baseline
      characteristics. At Visit 1, subjects must not have a history of utilization of acute
      treatment greater than 14 days per month in the preceding 3 month period. Subjects must have
      a current history of ICHD-3beta migraine with 6-14 migraine days per month in the 3 months
      prior to the study enrollment. Eligible subjects will be randomly assigned to one of two
      groups in a 1:1 ratio. Randomization will occur using a computer-generated allocation
      schedule. Subjects meeting entrance criteria as determined both at screening and through the
      review of the baseline headache diary will be given the lowest available allocation number
      for that site. Migraine preventative use is permitted if the subject has been on a stable
      does for at least 2 months prior to screening and has not failed more than 3 migraine
      preventatives due to lack of efficacy. The study will consist of 5 office visits per subject:
      Visit 1 - screening, Visit 2 - randomization, and Visits 3 to 5 - three-month treatment
      period. During the baseline period, the subject will treat migraines with their current
      preferred acute treatment of choice.
    

Intervention name(s): Dextromethorphan and quinidine; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Nuedexta
Intervention MeSH terms: Quinidine; Dextromethorphan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Episodic Migraine; Migraine; Headache
A Placebo-controlled Study With an Extension Examining the Safety and Efficacy of Alefacept in Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomized, double-blind, 24-week study of patients with psoriatic arthritis comparing
      alefacept + methotrexate (MTX) vs. placebo + MTX followed by a 24-week open-label extension
      with only alefacept + MTX treatment.
    

Detailed description: 
      Patients who completed the initial 24-week treatment course and met the inclusion and
      exclusion criteria for the 24 week open-label extension continued on their stable MTX dose
      and also received alefacept throughout this extension.
    

Intervention name(s): Alefacept; Methotrexate; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intramuscular; Oral; Intramuscular
Other intervention name(s): Amevive, ASP0485
Intervention MeSH terms: Methotrexate; Alefacept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Psoriatic arthritis; psoriasis; Alefacept
The Impact of Sucrose Ingestion Post-Exercise on Liver and Muscle Glycogen Repletion.
Condition: Liver and Muscle Glycogen Replenishment Post-exercise
Study type: Interventional

Summary: 
      Carbohydrate is stored in the body as glycogen, which is mainly found in the liver and
      muscle. During endurance exercise, muscle glycogen is used as fuel for the working muscles
      and liver glycogen is broken down to provide glucose to maintain blood glucose (sugar)
      levels. Both liver and muscle glycogen are important for our ability to perform
      intense/prolonged endurance exercise. Therefore, it is important to replete these stores
      after an intense/prolonged endurance exercise session in order to recover and perform
      optimally during a subsequent exercise bout, especially if the next exercise session is
      within 24h (e.g. stage races such as the Tour de France, tournament-style competitions such
      as the Olympic games and ultra-endurance events).

      Carbohydrate intake has been shown to increase the availability of glycogen in the muscle and
      liver after exercise. The carbohydrates typically found in sports drinks are glucose and
      sometimes fructose. It has been observed that the ingestion of glucose will lead to a maximum
      rate of absorption of approximately ~1 g/min. However, if we also provide a different source
      of carbohydrate (fructose) then this is absorbed through a different pathway and therefore we
      can absorb up to ~1.75 g/min of carbohydrate. In addition, both carbohydrate sources are
      metabolised differently in the human body. By supplementing both glucose and fructose, we can
      potentially replenish the liver and muscle glycogen stores at a faster rate than ingestion of
      glucose only.

      Sucrose is a naturally occurring sugar that is made up of a single glucose and single
      fructose molecule. Therefore, theoretically, this can use the two different pathways of
      absorption and also maximise carbohydrate delivery. It is not yet known however, what impact
      this has on our liver and muscle glycogen stores post-exercise when supplemented in
      relatively high amounts. Therefore the aim of this study is to assess whether relative high
      amounts of sucrose ingestion will improve liver and muscle glycogen repletion after endurance
      exercise.
    


Intervention name(s): Sucrose; Glucose
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science