bioihbjkbjnl/mcl2 huggingface dataset:
Growth Hormone Secretagogue MK-0677 Effect on IGF-1 Levels in ESRD Patients
Condition: Chronic Kidney Disease; End Stage Renal Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      The objective of this study is to determine MK-0677 increases IGF-1 in patients with end
      stage renal disease (ESRD) on hemodialysis.
    

Detailed description: 
      With development and progression of chronic kidney disease (CKD) to end stage renal disease
      (ESRD), malnutrition becomes an increasingly severe problem. This is thought to occur from
      two mechanisms: decreased appetite secondary to uremia and development of a catabolic
      inflammatory milieu. Patients experience decreased muscle mass and functional activity
      associated with increased morbidity and mortality. Many therapies to improve poor nutritional
      state have been used with little success. Growth hormone (GH) and insulin like growth hormone
      (IGF-1) improve muscle mass, quality of life, nutritional parameters, immune and physical
      functions but must be given parenterally and are limited by expense and patient compliance.
      Recently, the endogenous GH receptor secretagogue (GHRS) ghrelin has been shown to raise
      endogenous GH and improve food intake but must be given parenterally and is not available.
      The experimental drug MK-0677, a synthetic GHRS, ghrelin mimetic, which is given orally, has
      recently been shown to increase IGF-1 and muscle mass in the elderly. Its effects in CKD and
      ESRD are unknown. We will study the effects of MK-0677 on renal patients. Specifically, we
      hope to show that the drug increases IGF-1 in renal patients, and has similar effects to
      exogenous GH and IGF-1. Subjects will be ESRD hemodialysis patients. This protocol is an
      investigator-initiated, randomized, double-blind crossover, placebo-controlled pilot study.
      The study's primary outcome is IGF-1 levels for subjects. Secondary outcomes will be levels
      of cytokines, esterase, leptin, insulin, ghrelin, TNF-alpha, CRPs, IL-1, IL-6, IL-10, and
      adiponectin.
    

Intervention name(s): MK-0677; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The dosage of the drug is 25mg, subjects will take one pill a day for about 30 days.; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Chronic kidney disease; End stage renal disease
A Safety and Dose Finding Trial of C-Tb, When Given to Adult Patients Recently Diagnosed With Active Tuberculosis
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to assess the safety of two doses of C-Tb (0.01 and 0.1 µg/0.1 mL)
      when administered intradermally by the Mantoux technique to patients in the acute phase of
      treatment against active TB. The secondary objectives are to assess the immune response of
      two doses (0.01 and 0.1 µg/0.1 mL) of C-Tb from the size of induration and to assess the
      safety of unpreserved C-Tb and C-Tb preserved with 0.5% phenol (local reactions).
    

Detailed description: 
      This clinical trial is a single centre phase Ib open dose adjustment study with respect to
      the dose of C-Tb combined with a double blind randomised, split-body comparison of
      unpreserved C-Tb and C-Tb preserved with 0.5% phenol (each patient receives the unpreserved
      version in one arm and the preserved version in the other arm).
    

Intervention name(s): rdESAT-6 + rCFP-10 (C-Tb)
Intervention type(s): Biological
Intervention description(s): rdESAT-6 + rCFP-10 (C-Tb) skin test +/- phenol administered intradermally by the mantoux injection technique. Each patient receives the unpreserved version in one arm and the preserved version in the other arm in double blind manner.
Other intervention name(s): rdESAT-6 + rCFP-10; C-Tb
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: tuberculosis; ESAT-6; CFP-10; skin test; diagnostic test
Effects of Modified Constraint-Induced on Chronic Stroke Patients
Condition: Stroke; Rehabilitation
MeSH terms: Stroke
Study type: Interventional

Summary: 
      In the present study, it was aimed to compare the proprioception training applied in addition
      to conventional treatment and Modified Constraint-Induced Movement Therapy treatment in
      patients with chronic strokes and to investigate the effects on proprioception, spasticity,
      functional motor skills and daily living activities in the upper extremity.
    


Intervention name(s): modified constraint-induced therapy; Proprioceptive Training; conventional rehabilitation
Intervention type(s): Other; Other; Other
Intervention description(s): Patients received conventional rehabilitation and modified constraint-induced therapy schedule; Patients received conventional rehabilitation and Proprioceptive Training schedule; Patients received conventional rehabilitation schedule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Modified constraint-induced therapy; Proprioceptive Training; conventional rehabilitation
A Study of Soticlestat in Healthy Adult Nondependent Recreational Drug Users With Central Nervous System (CNS) Depressant Experience
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main aim is to evaluate the relative abuse potential of soticlestat in healthy adults who
      has used central nervous system (CNS) depressants for recreational nontherapeutic reasons.
    

Detailed description: 
      The drug being tested in this study is called soticlestat. Soticlestat is being tested in
      healthy participants. This study will assess the relative abuse potential of soticlestat
      compared to alprazolam and placebo in healthy adult, nondependent recreational drug users
      with CNS depressant experience. The study will enroll approximately 110 participants.
      Participants will be randomly (by chance, like flipping a coin) assigned to treatments of the
      study.

      Treatment order will remain undisclosed to the participants and study doctor (unless there is
      an urgent medical need). This single center trial will be conducted in the United States.
      Participants will be followed up for up to 7 days after the last dose of study drug for a
      follow-up assessment. The overall time to participate in this study is approximately 11
      weeks.
    

Intervention name(s): Soticlestat 300 mg; Soticlestat 600 mg; Soticlestat 900 mg; Alprazolam; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Administered orally.; Administered orally.; Administered orally.; Administered orally.; Administered orally.
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Drug Therapy
An Evaluation of LEO 138559 in Adults With Moderate to Severe Atopic Dermatitis.
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a clinical study in adult participants with moderate to severe atopic dermatitis
      (AD).

      The purpose of the study is to test a new medicine (LEO 138559) given by injection to see if
      it works to treat AD and what the side effects are when compared with a placebo injection
      with no medical ingredient.

      The study will last up to 36 weeks for each participant. The study will include a treatment
      period of 16 weeks, during which the participants will receive the injections, followed by a
      period of 16 weeks without treatment with the main purpose of continuing safety evaluations.
      The participants will regularly visit the clinic for tests and the study doctor will evaluate
      their AD. The participants will also be asked to answer questions about their AD symptoms and
      quality of life.
    


Intervention name(s): LEO 138559; LEO 138559 placebo
Intervention type(s): Drug; Drug
Intervention description(s): LEO 138559 is an antibody given by injection just under the skin.; LEO 138559 placebo is given by injection just under the skin. LEO 138559 placebo contains the same excipients in the same concentration as LEO 138559, except for the medical ingredient LEO 138559.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacokinetic and Exploratory Biomarker Study of ABT-126 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to determine the cerebrospinal fluid (CSF) levels of ABT-126
      and to examine the effects of ABT-126 on exploratory biomarkers after administration of a
      single does of ABT-126 in healthy volunteers.
    


Intervention name(s): ABT-126; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ABT-126 administered on Day 1 of Period 1; Placebo for ABT-126 administered on Day 1 of Period 2
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Healthy Volunteers
Effects of GABA Modulator AZD7325 on Cortical Excitability
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      GABA (gamma-aminobutyric acid) is the main inhibitory compound in the human brain. Drugs that
      enhance its effects by binding on GABA receptors (e.g., benzodiazepines) are used to treat
      various diseases such as epilepsy, insomnia, anxiety or movement disorders. However, the use
      of these medications is often compromised due to their side effects, like sedation, cognitive
      impairment, and addiction.

      Many of these side effects have been linked to a particular type of GABA receptor (GABA A
      alpha 1). Therefore, effort is being made to develop drugs that do not act on this receptor,
      but maintain their beneficial properties by acting on other types of GABA receptors. AZD7325
      is a drug that selectively acts on GABA A alpha 2 and A alpha 3 receptors, but not A alpha 1.
      It has been tested in more than 700 people and so far proved to be generally well tolerated.
      Positron emission tomography (PET) study in humans demonstrated that AZD7325 binds to GABA A
      receptors in the brain after a single dose. Early clinical studies have shown that it has
      less sedative and cognitive adverse events as compared with a benzodiazepine lorazepam.

      In this study, we will investigate its effects on short interval intracortical inhibition
      (SICI). SICI is neurophysiological marker of inhibitory processes in the motor cortex. It is
      obtained non-invasively by using transcranial magnetic stimulation (TMS). In TMS, magnetic
      impulses applied over the scalp that in turn induce a current in a small area of the brain.
      If applied over the motor areas of the brain, impulses result in muscle twitch that is
      recorded with surface electrodes. SICI is enhanced by certain drugs like benzodiazepines that
      act on GABA A alpha 1,2,3, and 5 receptor subtypes, but not by zolpidem acting solely on
      alpha 1 subtype. Because GABA A alpha 5 receptor subtype is less common in the cortex, it has
      been concluded that the drug effects on SICI are related to GABA A alpha 2 and alpha 3
      receptors.

      If AZD7325 proves to enhance SICI in healthy volunteers, this would create the grounds for
      the use of this medication to treat certain neurological disorders in which SICI has been
      found to be impaired (e.g., dystonia).
    


Intervention name(s): 2 mg AZD7325; 10 mg AZD7325; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single 2 mg oral dose of AZD7325; A single 10 mg oral dose of AZD7325; A single oral dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: GABA modulator; AZD7325; Short interval intracortical inhibition; volunteers
Evaluation of Insecticide Treated Nets and Wall Liners for the Prevention of Malaria
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether insecticide treated wall liners, in
      combination with insecticide treated nets, reduce the incidence of malaria infections
      compared to insecticide treated nets alone.
    

Detailed description: 
      Insecticide treated nets (ITNs) have been shown to reduce malaria related morbidity and
      mortality and are increasingly being scaled up throughout sub-Saharan Africa. However, ITNs
      alone are unlikely to reduce transmission to zero in most settings and additional vector
      control tools are necessary. One new promising strategy is the use of insecticide treated
      wall liners (ITWLs). These are textiles treated with an insecticide that are used to line the
      inner walls of houses. The wall liners are considered a long-lasting alternative to indoor
      residual spraying which is also used for malaria vector control but is expensive to
      implement.

      Within 6 pairs of villages, we plan to randomly allocate one village in each pair to receive
      either ITNs or ITNs plus ITWLs. Households will be randomly selected from each village and
      all children between the ages of 6 months and 11 years will be enrolled in a cohort study.
      The children will be cleared of existing infections and then followed monthly until they are
      found to be infected with malaria. The study will last for 6 months and will demonstrate
      whether the ITWLs provide additional protection against malaria over that provided by the use
      of ITNs.
    

Intervention name(s): Insecticide treated nets and wall liners; Insecticide treated nets alone
Intervention type(s): Other; Other
Intervention description(s): Participants will be provided a long-lasting insecticide treated net recommended by the WHO Pesticide Evaluation Scheme. Households where participants reside will be fitted with insecticide treated wall liners.; Participants will be provided with a long-lasting insecticide treated net recommended by the WHO Pesticide Evaluation Scheme
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Insecticide treated wall liners; Insecticide treated nets; Incidence cohort
Cervical Neuromodulation and Nociceptive Processing
Condition: Nociceptive Pain
MeSH terms: Nociceptive Pain
Study type: Interventional

Summary: 
      Several studies have demonstrated that direct currents delivered through the skin at the
      level of the lumbar spinal cord can influence spinal cord function. In human volunteers,
      anodal lumbar transcutaneous spinal direct current stimulation (tsDCS) alters spinal
      processing of nociceptive inputs. Whether cervical tsDCS is able to do the same is less well
      known.
    

Detailed description: 
      The investigators will compare the effects on the nociceptive processing of healthy
      volunteers of cervical and lumbar tsDCS. This study will be a double-blinded,
      sham-controlled, cross-over trial. Each participant will undergo two experimental sessions
      (anodal cervical tsDCS and sham lumbar tsDCS vs. sham cervical tsDCS and anodal lumbar
      tsDCS), separated by at least one week.
    

Intervention name(s): Starstim (Neuroelectrics)
Intervention type(s): Device
Intervention description(s): Anodal transcutaneous spinal direct current stimulation (a-tsDCS)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: tsDCS; non-invasive neuromodulation; healthy volunteers
Testosterone Replacement Therapy in Chronic Spinal Cord Injury
Condition: Spinal Cord Injury; Hypogonadism
MeSH terms: Spinal Cord Injuries; Hypogonadism; Wounds and Injuries
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      It has long been recognized that co-morbidity associated with multiple metabolic syndrome,
      such as adverse body composition, insulin resistance and autonomic nervous system impairment,
      may lead to significant increase in cardiovascular morbidity and mortality. It is unclear
      whether the co-morbidity evident in this population are due directly to their immobility or
      are the result of unfavorable changes in their underlying hormonal milieu. The purpose of
      this study is to determine the effect of testosterone replacement therapy in hypogonadal
      males on:

      body composition, i.e. lean tissue and fat mass, glucose tolerance, resting energy
      expenditure, autonomic-cardiovascular integrity, muscular strength, psychological assessment
    

Detailed description: 
      This study is 24 months in duration. Men who have consented to pre-screening serum
      testosterone draw and are found to have total testosterone levels averaging ≤ 11.3 nmol/l
      will start testosterone replacement therapy after a 6-month baseline period. Once treatment
      begins subjects will place a testosterone replacement patch (5 or 10 mg/day) on various sites
      of the body daily. Subjects will visit the lab after 2,6, 12, and 18 months of therapy for
      testing; however they will stop taking the patch at the 12 month visit. If needed, a steroid
      cream will be provided to the subjects should any skin irritations occur. If the patch causes
      persistent skin irritations, despite use of the steroid cream, then a testosterone gel may be
      used. Detailed instructions and precautions using the gel are outlined in the consent form
      and will be reviewed with the subject.

      Those men who have consented to pre-screening serum testosterone and are found to have normal
      levels of total testosterone (testosterone total ≥ 11.4 nmol/l) are eligible to participate
      as a control subject for the full 24-month period of the study. These subjects visit the lab
      at baseline (BL), 12 and 24 months for the same testing as those in the treatment group.
    

Intervention name(s): Testosterone Transdermal System (Androderm 5 mg patch)
Intervention type(s): Drug
Intervention description(s): Testosterone Transdermal System (Androderm 5 mg patch)
Other intervention name(s): Androgel (Testim) and Underarm Testosterone (Axiron)
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal Cord Injury; Testosterone Replacement Therapy; Dual Energy X ray Absorptiometry; Lean Tissue Mass
Effect of Triple Antibiotic Paste as an Intracanal Medication With an Anti-Inflammatory Drug on Post-operative Pain.
Condition: Asymptomatic Necrotic Teeth
MeSH terms: Pain, Postoperative; Necrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether the use of triple antibiotic paste as
      intracanal medication with an anti-inflammatory drug, compared to a calcium hydroxide will
      reduce postoperative pain and intracanal bacteria or not in patients with asymptomatic
      necrotic teeth.
    

Detailed description: 
      This trial is aiming to answer a clinical question whether in patients with asymptomatic
      necrotic teeth, the use of triple antibiotic paste as intracanal medication with an
      anti-inflammatory drug, compared to a calcium hydroxide, reduce postoperative pain and
      intracanal bacteria or not? trial design will be Randomized, controlled, double blinded,
      unicenter, parallel, two-arm, superiority trial with 1:1 allocation ratio.
    

Intervention name(s): triple antibiotic paste with an anti-inflammatory drug
Intervention type(s): Other
Intervention description(s): Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast)
Intervention MeSH terms: Anti-Bacterial Agents; Anti-Inflammatory Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: post operative pain; triple antibiotic paste; intracanal medication
Proof of Concept Study of Cognitive Improvement in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to demonstrate that AZD3480 improves cognition in patients with
      stable schizophrenia who are being treated with an atypical antipsychotic and who are active
      cigarette smokers, to assess the safety and tolerability of AZD3480 and to define the optimal
      dose(s) to be used in future trials.
    


Intervention name(s): AZD3480
Intervention type(s): Drug
Intervention description(s): oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Cognitive Deficits
Effects of Moderate Physical Activity on Early Symptoms of Peripheral Diabetic Neuropathy in Type-II Diabetes: A Randomized Clinical Trial
Condition: Peripheral Diabetic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study determines the effects of moderate physical activity on early symptoms of
      peripheral diabetic neuropathy in type-II diabetes. Most of the literature shows the impact
      of physical activity to manage/controlling diabetes. Some studies were conducted on animals
      to study the impact of physical activity on diabetic neuropathy and neurogenesis. There is no
      study on the impact of physical activity to manage early symptoms of peripheral diabetic
      neuropathy in patients with type-II diabetes in humans. This study finds the impact of
      moderate physical activity to manage early symptoms of peripheral diabetic neuropathy in
      patients with type-II diabetes in humans.
    


Intervention name(s): Moderate Physical Activity for Peripheral Diabetic Neuropathy
Intervention type(s): Other
Intervention description(s): Moderate physical activity can increase movement and heart rate are particularly important for people suffering with peripheral neuropathy. Physical activity can improve blood circulation, which strengthens nerve tissues by increasing the flow of oxygen.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 diabetes mellitus, moderate physical activity, HbA1c, diabetic neuropathy