bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia
Condition: Herpes Zoster
MeSH terms: Herpes Zoster; Neuralgia
Study type: Interventional
Phase: Phase 4

Summary: 
      All eligible Herpes Zoster patients will be randomized into two groups. Group 1 will be the
      treatment group receiving Pregabalin 75 mg twice daily for 4 weeks in addition to other
      routine treatment. Whereas, group 2 will be the control group receiving all routine treatment
      similar to group 1 except Pregabalin. Instead control group will receive Placebo.
    

Detailed description: 
      This study wants to see the role of Pregabalin in acute herpetic neuralgia pain reduction and
      for the prevention of post herpetic neuralgia incidence as compared to placebo group. For
      this purpose, all eligible Herpes Zoster patients will be randomized into two groups (41
      patients in each group i.e.82 total patients). Group 1 will be the treatment group receiving
      Pregabalin 75 mg twice daily for 4 weeks in addition to other routine treatment. Whereas,
      group 2 will be the control group receiving all routine treatment similar to group 1 except
      Pregabalin. Instead of pregabalin, control group will receive Placebo. The pain will be
      evaluated in all patients in each follow visits (weekly follow up for 4 weeks then monthly
      follow up for next three months). If it is difficult for the patient to present physically,
      telephonic follow up will be done to find the pain score in the required time. Also, DLQI
      (Dermatological life quality index) will be assessed at the first and last visit of the
      patient.

      At the end, pain score will be compared between the two groups.
    

Intervention name(s): Pregabalin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group); Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group)
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blinded randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Herpes Zoster; Herpetic neuralgia; Pregabalin
Freedom Study: Myfortic in Kidney Transplant Patients
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to evaluate that 3 immunosuppressant regimens will have
      comparable kidney function results in kidney transplant patients.
    


Intervention name(s): Myfortic
Intervention type(s): Drug
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MPA; Kidney Transplantation; Acute rejection; Kidney function
SMART: A Social and Mobile Weight Control Program for Young Adults
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The Social/Mobile Approach to Reduce Weight (SMART) study is a 24-month randomized control
      trial designed to evaluate the hypothesis that weight status at 24 months will be
      significantly better for the SMART intervention recipients than for those who receive the
      comparison condition.
    

Detailed description: 
      The focus of the SMART study is to develop an intervention to promote weight loss in
      overweight or obese young adults. The investigators will recruit college and university
      students to evaluate the effects of SMART on weight status and other metabolic, behavioral
      and psychosocial outcomes up to and including 24 months.

      The Primary aim of the study is to evaluate between condition differences in weight status at
      24 months.

      Secondary aims will assess the impact of the SMART intervention on: Diet, physical activity,
      sedentary behaviors, quality of life and depression at 6, 12, 18 and 24 months;
      Anthropometric measures (BP, waist circumference) at 6, 12, 18 and 24 months; Differences in
      weight status at 6, 18 and 24 months; Level of satisfaction and amount of use of the
      intervention components.

      These aims will be applied to overweight/obese young adults. Among overweight/obese young
      adults, the investigators will determine whether SMART produces weight loss.
    

Intervention name(s): Social/mobile weight loss promotion intervention.
Intervention type(s): Behavioral
Intervention description(s): Social/mobile intervention for weight loss promotion, compared to control group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity; Weight Loss; Healthy Lifestyle; Social; Mobile; Facebook; Text Messages
Therapeutic Intensification Plus Immunomodulation in HIV-infected Patients
Condition: HIV-1 Infection
Study type: Interventional
Phase: Phase 2

Summary: 
      Viral eradication in selected HIV-infected patients is possible with intensive antiretroviral
      therapy plus immunomodulation
    

Detailed description: 
      The overall strategy of the ERAMUNE 01 Trial is to treat selected patients with an optimal
      synergistic antiretroviral regimen plus one or more immunomodulating agents. Among
      immunomodulating treatments the candidates include therapies from two functional classes: 1)
      agents that target actively replicating cells and 2) agents activating latently infected
      cells31.

      The novelty of this approach is three-fold: first, the use of highly potent antiretroviral
      therapy combining drugs with different HIV enzymes targets or receptors and different
      penetrations in cells, with the aim to suppress virus to truly undetectable levels as
      measured by the most sophisticated viral quantification techniques; secondly, the addition of
      an immunomodulatory therapy that specifically targets viral reservoirs to this
      intensification strategy; and lastly, the rigorous selection of patients having already a low
      HIV reservoir as measured by peripheral blood HIV DNA content. To our knowledge, this type of
      strategy has not been implemented. We believe this strategy is feasible.
    

Intervention name(s): ART Intensification; Immunomodulation
Intervention type(s): Drug; Biological
Intervention description(s): Current ART regimen plus raltegravir and maraviroc Raltegravir : 400 mg PO BID for 56 weeks Maraviroc : 150, 300 or 600 mg PO BID depending on concomitant ART treatment, for 56 weeks; Starting at Week 8, 1 cycle of 3 injections (1 per week) of recombinant human Interleukin-7 (r-hIL-7 / CYT107) at a 20 µg/kg dose.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Controlled viremia; Viral reservoirs; Virus eradication; Therapeutic intensification; Immunointervention
Yoga as a Treatment for Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effectiveness of a daily, 8-week treatment for
      insomnia using yoga, relaxation exercises or sleep hygiene.
    

Detailed description: 
      Insomnia is a sleep disorder characterized by a chronic difficulty in initiating and
      maintaining sleep which has a relatively high prevalence and a significant socioeconomic
      cost. There is good evidence that cognitive and/or physiological arousal, associated with
      sustained sympathetic activation, is one of the underlying causes of insomnia. Relaxation
      treatments such as progressive relaxation and meditation which address the cognitive and
      somatic arousal associated with insomnia have been found to be effective. Yoga is a
      comprehensive discipline which includes physical exercises, postures, breathing techniques,
      and meditation, for the purpose of improving health and well being. Research studies have
      documented the effectiveness of yoga in reducing sympathetic activation and cognitive and
      somatic arousal and in the treatment of specific medical disorders. Although it has been used
      and recommended for the treatment of insomnia, its effectiveness has not been evaluated in a
      randomized, controlled study. The aim of this proposal is to evaluate the effectiveness of
      yoga, relaxation exercises or sleep hygiene in the treatment of chronic psychophysiological
      insomnia. A subjective measure of sleep onset latency will be derived from daily sleep
      diaries, and an objective measure will be drawn from polysomnographic recordings. Sleep onset
      latency will be evaluated before and after a two month treatment period in a total of 48
      young men and women who have been carefully screened for psychiatric and medical disorders.
      Subjects will be assigned to a yoga, relaxation exercise, or sleep hygiene treatment group.
      We anticipate that yoga practice will prove to be an effective treatment for insomnia which
      will yield significant improvements in sleep onset latency. We also anticipate that these
      improvements will be maintained at long-term follow up evaluation.
    

Intervention name(s): Yoga, Relaxation Exercises, Sleep Hygiene
Intervention type(s): Behavioral
Intervention description(s): Sleep hygiene and relaxation exercises, with additional yoga
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insomnia; Yoga; Meditation; Behavioral treatment
Effects of Mindfulness Practice on Healthcare Workers
Condition: Psychological Burnout
MeSH terms: Burnout, Psychological
Study type: Interventional

Summary: 
      This study aims to examine the effects of mindfulness practice administered using a mobile
      app on psychological health among health care workers in Singapore.
    

Detailed description: 
      Research has shown that health workers are particularly at risk of experiencing heightened
      risks of burnout and psychological symptoms when dealing with a health pandemic, including
      the current COVID-19 pandemic (Lai et al., 2020; Tan et al., 2020; Wu et al., 2009). The
      increased risk reflects an urgent need to develop feasible psychological interventions to
      mitigate burnout and psychological symptoms among health workers. The present study aims to
      examine the effects of a brief mindfulness intervention delivered using a mobile application
      (HeadSpace) on psychological functioning in the context of coping with the COVID-19 pandemic
      in a sample of health workers in Singapore. A total of 80 health workers will be recruited
      and randomly assigned to using a mindfulness practice app or a cognitive games app daily over
      a period of 21 days. They will be assessed at baseline, post-intervention, and at one-month
      follow-up on depressive symptoms, anxiety, stress, burnout, compassion fatigue, compassion
      satisfaction, post-traumatic stress symptoms, trait mindfulness, self-compassion, sleep
      quality, working memory, and fear of COVID-19 infection. Results of the study will have
      implications on developing cost-effective interventions to mitigate psychological symptoms
      among health workers in the context of heightened pandemic-related stress.
    

Intervention name(s): Mindfulness Practice; Cognitive training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 10-15 mins of daily mindfulness practice using HeadSpace, for 3 weeks; 10-15 mins of cognitive games using Lumosity, for 3 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
The Effect of a Probiotic Strain on Aspirin-induced GI Damage.
Condition: Side Effects of Acetylsalicylic Acid Use
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is a single-site, randomised, double-blind, placebo-controlled, two-armed,
      parallel-group trial in healthy, adult volunteers. The trial will investigate the effect of
      daily intake of a probiotic strain versus placebo when co-administered to daily intake of
      300mg of Aspirin. The objective is to investigate the ability of the probiotic strain to
      attenuate and/or reverse Aspirin-induced deterioration of the small intestine.
    

Detailed description: 
      The trial includes a run-in period of two weeks duration followed by a six weeks intervention
      period where a probiotic strain/placebo and Aspirin is co-administered. After the 6 weeks,
      probiotic strain/placebo is given for two additional weeks to investigate the potential
      effects of the probiotic strain on intestinal healing after long-time Aspirin use.

      Subjects will participate in the trial for a total duration of 10 weeks including the run-in
      phase. Besides the screening visit, the trial will consist of 6 visits.

      After having given their written informed consent, subjects will complete screening
      procedures to evaluate their eligibility for participation in the trial and complete a run-in
      period of two weeks duration to washout possible pre-trial probiotics and/or use of
      medication. After baseline assessments at Visit 2, subjects will start daily intake of 300mg
      Aspirin and also be randomly assigned to 8 weeks daily intake of active or placebo product in
      a ratio of 1:1.
    

Intervention name(s): probiotic strain; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 8 weeks of treatment with probiotic strain; 8 weeks of treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Aspirin challenge model
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Increased Liver Stiffness: A Study of Acoustic Radiation Force Impulse (ARFI) Elastography
Condition: Liver Fibroses
MeSH terms: Liver Cirrhosis
Study type: Observational

Summary: 
      The goal of this study is to determine if ultrasound tools can be used to detect liver
      stiffness. Acoustic radiation force impulse (ARFI) elastography and backscatter will be used
      to see if they can detect liver stiffness in different populations of patients with liver
      disease.

      The study is measuring liver stiffness in pediatric patients aged 2-5 years. Patients either
      have had a Fontan cardiac surgery or have liver disease.

      Ultrasound scanning takes images of the liver and has much lower risks for patients. ARFI
      elastography and other tools can be used to measure liver stiffness.
    

Detailed description: 
      If patients have liver congestion, reversing it could prevent liver fibrosis, which cannot be
      treated. Liver fibrosis has serious health risks and is associated with a higher chance of
      developing liver cancer later in life.

      Subjects from two patient populations will be enrolled in order to test ultrasound
      technologies. A total of 30 subjects between 2-5 years of age will be enrolled.

        1. 15 children with increased liver stiffness due to the Fontan operation

        2. 15 children with increased liver stiffness caused by Biliary Atresia.
    

Intervention name(s): Ultrasound with ARFI (acoustic radiation force impulse); Ultrasound with backscatter imaging
Intervention type(s): Device; Device
Intervention description(s): This technology uses sound waves to measure the stiffness of tissue.; This ultrasound tool gathers data from the waves returning from imaged tissue.
Other intervention name(s): elastography
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will either be scheduled for a Stage 3 Fontan cardiac operation or have chronic
        liver disease caused by biliary atresia.
      
Keywords: liver stiffness Fontan
Pharmacokinetic and Safety Study of Cenicriviroc and Pioglitazone, When Dosed Alone or in Combination
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A single center, open-label, fixed sequence study to evaluate the pharmacokinetics (PK) of
      Cenicriviroc (CVC) administered with and without Pioglitazone (PGZ), and to evaluate the PK
      of PGZ administered with and without CVC.
    

Detailed description: 
      This is a open-label, fixed-sequence, 3-period study being conducted in a single center to
      evaluate the following:

        -  PK of CVC administered with and without PGZ

        -  PK of PGZ administered with and without CVC

        -  Safety of CVC administered with and without PGZ

        -  Tolerability of CVC administered with and without PGZ
    

Intervention name(s): Cenicriviroc; Pioglitazone
Intervention type(s): Drug; Drug
Intervention description(s): CVC 150 mg QD on Days 1-10, washout on Days 11-20, PGZ 45 mg QD on Days 21-30, and CVC 150 mg QD + PGZ 45 mg QD on Days 31-40; PGZ 45 mg QD on Days 1-10, washout on Days 11-20, CVC 150 mg QD on Days 21-30, and CVC 150 mg QD + PGZ 45 mg QD on Days 31-40
Other intervention name(s): CVC 150 mg; PGZ 45 mg
Intervention MeSH terms: Pioglitazone; Cenicriviroc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Repetitive Transcranial Magnetic Stimulation in Adult Attention Deficit Disorder
Condition: Attention Deficit Disorder; ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of the current open-lable study was to use low-frequency repetitive transcranial
      magnetic stimulation (rTMS) to improve the attention deficits in a sample of adult patients
      suffering from attention deficit disorder. Participants received 10 sessions of rTMS over Fz
      (located using the EEG 10-20 international system) and underwent assessments of their
      attentional capacity using the gradCPT task in an fMRI scanner, before and after the
      intervention. Other behavioral assessments of their attention symptoms have also been
      conducted.
    


Intervention name(s): repetitive Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): Magnetic pulses delivered to the Fz area of the brain in a low frequency (1 Hz) manner.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rTMS; ADHD; ADD; fMRI
The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study
Condition: Metabolic Syndrome x
MeSH terms: Metabolic Syndrome; Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with metabolic syndrome, insulin resistance, and elevated triglycerides of 150 mg/dl
      or higher will be randomized to one of four groups: 1) placebo; 2) metformin; 3) fenofibrate;
      or 4) combined metformin and fenofibrate for a period of 12 weeks after titration to target
      dose. We are interested in the effects of these therapies on triglyceride levels, HDL-C,
      insulin resistance, and markers of inflammation.
    


Intervention name(s): Study drugs: Metformin and fenofibrate; Study Drug: Metformin; Study Drug: fenofibrate; Metformin and Fenofibrate placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 145mg fenofibrate once/day and 2000mg/day of metformin for arm 3.; 2000mg/day; 145mg/day of fenofibrate; placebo metformin and fenofibrate
Intervention MeSH terms: Metformin; Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: metabolic syndrome; Triglycerides; Insulin Resistance; inflammation; Cardiovascular Disease; Elevated triglycerides; without diabetes
Evaluating the Safety, Tolerability, and Pharmacokinetics of BIIB095 in Healthy Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the safety and tolerability of single- and
      multiple-ascending oral doses of BIIB095 in healthy participants. The secondary objectives
      are to characterize the single- and multiple-oral-dose PK of BIIB095 in healthy participants
      and to investigate the effect of food on the single-oral-dose PK of BIIB095 in healthy
      participants.
    


Intervention name(s): BIIB095; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in the treatment arm.; Administered as specified in the treatment arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic pain; Neuropathic pain; Neuralgia; Healthy volunteers
Investigation of the Effect of 8-week Controlled High Intense Interval Training in Type 2 Diabetic Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The overall objective of this study is to examine the blood flow in the thigh muscles and
      sugar metabolism before and after 8 weeks of high intensity interval training (HIIT) on a
      bicycle ergometer in patients with type 2 diabetes (T2D) and matched controls. The following
      parameters are included in the assessment:

        -  Sugar Metabolism

        -  Muscle and fat mass

        -  The blood flow at rest around the thigh muscles

        -  Oxygen uptake test on a bicycle ergometer and 5 km time trial
    

Detailed description: 
      Type 2 diabetes (T2D) can be defined as a bihormonal metabolic disorder characterised by
      insufficient insulin secretion and abnormal glucagon secretion. It is however well
      established that physical activity per se improves glucose and may postpone or even slow down
      in the diabetic population. Glycaemic control may be improved more by high intensity interval
      training than by intensities from existing recommended guidelines. Additionally, there seems
      to be accumulating evidence that high intensity interval training induces increased overall
      fat and abdominal fat mass loss as opposed to traditional continuous endurance training
      Therefore we hypothesise that 3 weekly sessions of high intensity interval training (10×60
      sec. at an intensity inducing 90% of maximal heart frequency with a recovery of 60 sec.
      between each bout) over 8 weeks improves overall glycaemic control (glucose, insulin and
      glucagon), inflammatory status (interleukins, cytokines, chemokines and cell adhesion
      molecules) and blood flow (NO and PGI2 vasodilatory capabilities).
    

Intervention name(s): Physical training
Intervention type(s): Other
Intervention description(s): Performed supervised high intensity interval training 3 times a week over 8 weeks on a bicycle ergometer (with watt meter). During the training period, the trainee individually established program, each time with 10 × 60 sec. workout (interspersed with 60 sec. break) corresponding to a force which during the test cycle induces ~ 90% of the maximum heart rate. The time spent per session is expected to last ~ 25 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Type 2 diabetes; Interval training; Insulin resistance; fat metabolism