bioihbjkbjnl/mcl2 huggingface dataset:
Double Blind Trial of Duloxetine in Chronic Fatigue Syndrome
Condition: Fatigue Syndrome, Chronic
MeSH terms: Fatigue Syndrome, Chronic; Syndrome; Fatigue
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of duloxetine compared with
      placebo for reducing fatigue in patients diagnosed with Chronic Fatigue Syndrome (CFS).
    

Detailed description: 
      Chronic fatigue syndrome (CFS) is characterized by severe disabling fatigue of at least six
      months duration that cannot be fully explained by an identifiable medical condition . Pain
      symptoms are also a part of the diagnostic criteria for CFS, and include muscle pain,
      multi-joint pain, and headaches. The prevalence of CFS ranges from 0.007 to 2.8 % in the
      general adult population and 0.006 to 3.0% in primary care practice (2). Although most who
      receive a CFS diagnosis are 30-40 years of age, Caucasian, and female, CFS affects both women
      and men, adults and children, and all racial and socioeconomic classes.

      Patients with CFS have 2-4 times the rate of depression and anxiety compared with the general
      population. CFS is also commonly comorbid with fibromyalgia, a disorder characterized by
      chronic widespread pain, tenderness, fatigue, sleep and mood disturbances. In some samples,
      70% of patients with fibromyalgia also meet criteria for CFS. CFS and fibromyalgia are
      characterized by greater similarities than differences and may share pathophysiologic
      features. Like fibromyalgia, CFS is associated with chronic pain, sleep and mood
      disturbances. Because fibromyalgia responds to treatment with antidepressants, particularly
      the dual serotonin and norepinephrine reuptake inhibitors, including duloxetine,
      antidepressant trials in CFS are clearly needed.
    

Intervention name(s): Duloxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Duloxetine po 60-120 mg/day for 12 weeks; Sugar pill dose comparable to duloxetine
Other intervention name(s): Cymbalta; Sugar Pill
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fatigue; Fatigue syndrome, chronic; Chronic fatigue syndrome; CFS; Fibromyalgia
Assessing Endoloop-assisted Polypectomy in Patients With Antiplatelet Therapy
Condition: Colorectal Polyp
Study type: Interventional

Summary: 
      The aims of this study were to examine: 1) safety and feasibility of antiplatelet therapy
      interruption 7 days prior to polypectomy in patients with long-term antiplatelet therapy; 2)
      safety and feasibility of endoloop assisted snare polypectomy in patients with long-term
      antiplatelet therapy; 3) safety and feasibility of so called "ligate and let go" approach in
      patients with long-term antiplatelet therapy.
    


Intervention name(s): Endoloop-assisted "ligate and let go" colorectal polypectomy; Endoloop-assisted snare colorectal polypectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): The technique implies placement of endoloop snare on the base of large pedunculated colorectal polyps without consecutive snare polypectomy.; The technique implies placement of endoloop snare on the base of large pedunculated colorectal polyps with consecutive snare polypectomy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Intermittent Theta Burst Stimulation on Motor Learning in Healthy Adults
Condition: Healthy
Study type: Interventional

Summary: 
      This study investigates the effect of different application frequencies of intermittent theta
      burst stimulation on motor learning in healthy adults.
    


Intervention name(s): neuromodulation; motor learning training
Intervention type(s): Other; Other
Intervention description(s): neuromodulation: Neuromodulation is technology that acts directly upon nerves. It is the alteration-or modulation-of nerve activity by delivering electrical or magnetic stimulus/current.; motor learning training requires performing a sequential training called finger taping task
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
DAME: Induction of Labor or Waiting for Suspicion Fetal Macrosomia
Condition: Fetal Macrosomia
MeSH terms: Fetal Macrosomia
Study type: Interventional
Phase: Phase 4

Summary: 
      Aim of the study :The major aim is to evaluate the effectiveness of the induction of labor in
      case of fetal macrosomia on the reduction of neonatal traumatism risk. The secondary aims are
      to evaluate maternal morbidity and the risk of Caesarean in case of induction of labor,
      compared to a spontaneous labor.
    

Detailed description: 
      A clinical trial multicentric randomized controlled will be organized. A total of 1000 women
      will be recruited between 36 and 38 weeks of amenorrhoea (GW) if the pregnancy is single, in
      cephalic presentation and the fetus is estimated macrosomic for the gestational age (> 90e
      percentile clinically and >95° percentile sonographically).All agreeing patients will be
      randomized in one of the two following groups: - 1. Induction of labor between 37+0 and 38+6
      GW and within 3 day after the randomization. - 2. Expectancy until the spontaneous beginning
      of labor or up to 41 GW.The measurement of principal exit is the neonatal traumatism
      (criterion composite associating: dystocia of the shoulders, fractures osseous,
      paralysis/paresis of the plexus brachial or intracerebral haemorrhage).The secondary criteria
      are neonatal asphyxiation (arterial pH < 7.10 or Apgar < 7 to 5 minutes), the maternal
      traumatism (tear of 3rd or 4th degree) and the Caesarean. The long-term after-effects for the
      mother and her child will be also evaluated
    

Intervention name(s): Induction of labor vs waiting
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fetal macrosomia; Neonatal traumatism; Maternal morbidity
Study to Evaluate the Analgesic Efficacy of 28 Days' Oral Administration of AZD2066 Compared With Placebo in Patients With Painful Diabetic Neuropathy
Condition: Pain; Diabetic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate if AZD2066 can relieve the pain arising from
      painful diabetic neuropathy compared to placebo.
    


Intervention name(s): AZD2066; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule, once daily, 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28.; Capsule, once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Diabetic Neuropathy; PDN; Analgesia; Efficacy
Short and Long Time Effects of IASTM and Myofascial Release Techniques in Chronic Neck Pain
Condition: Chronic Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The aim of this study is to determine whether EYYDM and myofascial applications have short
      and long-term effects on pain and disability in individuals diagnosed with chronic neck pain.
    

Detailed description: 
      Participants will be randomly assigned to IASTM, myofascial release and control groups. In
      addition to conventional treatment, IASTM and myofascial release groups will be treated twice
      a week for 4 weeks. Conventional treatment will be applied to the control group for 4 weeks.
    

Intervention name(s): IASTM; Myofascial Release; 250W infrared application; TENS; Home exercise
Intervention type(s): Other; Other; Other; Device; Other
Intervention description(s): IASTM will be applied to the upper trapezius and sternocleidomastoid muscles of the participants for 90 seconds, with a frequency of 60 beats per minute.; Basic movements will be performed for 3 minutes in the rectus capitis, sternocleidomastoideus, hyoid region and upper trapezius regions.; For 15 minutes, 250W infrared application will be applied on the cervical region from a distance of 50 cm; TENS will be applied for 20 minutes at 80Hz frequency, with a current transit time of 150ms.; Cervical strengthening and stretching exercises five days a week will given
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Neck Pain; Disability; Pain
Study on Serum Zinc and Selenium Levels in Epileptic Patients
Condition: Generalized Epileptic
MeSH terms: Epilepsy
Study type: Observational [Patient Registry]

Summary: 
      This study was carried out with the purpose of evaluating zinc and selenium levels in serum
      of epileptic patients and compare with normal individuals.
    

Detailed description: 
      Forty patients aged 18 to 50 years visiting Vali-Asr hospital in Arak, I.R. Iran, who were
      diagnosed with generalized form of epilepsy by a neurologist for the first time were
      recruited as cases. The control group (n=40) was selected from healthy individuals, in whom
      no disease was diagnosed until this study, and were matched to the case group by age, sex,
      and economical status.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        all generalized and single epileptic patiants which were identify for fist time
      
Biospecimen description: 
      Serum were analysis for zinc and selenium
    
Keywords: zinc; selenium; serum; epilepsy; antioxidants
Pharmacokinetic Interaction Between Midazolam and ID-082 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical study in healthy male subjects to investigate whether the administration of ID-082
      can affect the fate in the body (amount and time of presence in the blood) of midazolam.
    


Intervention name(s): Midazolam; ID-082
Intervention type(s): Drug; Drug
Intervention description(s): Single oral administration of 2 mg midazolam under fasted conditions/outside of meal times; Administration of ID-082 under fasted conditions/outside of meal times
Intervention MeSH terms: Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study to Evaluate the Abuse Potential of AZD7325 in Healthy Recreational Central Nervous System (CNS) Depressant Users
Condition: Recreational CNS Depressant Use
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the abuse potential of AZD7325.
    


Intervention name(s): Lorazepam; AZD7325; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): mg, oral dose; mg, oral dose
Intervention MeSH terms: Lorazepam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Recreational CNS depressant; Abuse liability; Abuse potential; Healthy Recreational CNS Depressant Users
A Safety, Tolerability, Pharmacokinetics (PK) and Target Engagement (TE) Study of GSK3858279 in Healthy Participants and Evaluation of the Efficacy of Repeat Doses in Participants With Osteoarthritis (OA)
Condition: Pain, Inflammatory
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is the first administration of GSK3858279 in humans and will be conducted in two
      parts: Part A will consist of a single ascending dose escalation design to evaluate safety,
      tolerability, PK, TE and immunogenicity of either a single intravenous (IV) or a single
      subcutaneous (SC) dose. Approximately 48 healthy participants will be enrolled in 6 cohorts
      and randomized to 3:1 ratio (GSK3858279 or placebo). Part B will evaluate safety,
      tolerability, efficacy (pain), PK, TE and immunogenicity after repeat SC dosing.
      Approximately 50 OA participants will be randomized in a parallel group design to receive
      either GSK3858279 or placebo in a 1:1 ratio.
    


Intervention name(s): GSK3858279 IV; GSK3858279 SC; Placebo matching to GSK3858279 (SC or IV); Placebo matching to GSK3858279 (SC)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): GSK3858279 will be available as solution for injection to be administered via IV route.; GSK3858279 will be available as solution for injection to be administered via SC route.; Placebo will be available as sodium chloride solution to be administered via SC or IV route.; Placebo will be available as sodium chloride solution to be administered via SC route.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Participants will be randomized in 3:1 ratio to receive GSK3858279 and placebo in sequential manner in Part A. In Part B, participants will be randomized in parallel groups to receive either GSK3858279 or placebo.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pain; Osteoarthritis of the knee; Target engagement; GSK3858279; Pharmacokinetics; Sequential
Cognitive Behavior Therapy for Somatization Disorder
Condition: Somatoform Disorders
MeSH terms: Somatoform Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine the long-term effects of cognitive behavioral therapy on the physical
      symptoms, functioning, and health care utilization of people with multiple medically
      unexplained physical symptoms.
    

Detailed description: 
      Somatization disorder is a chronic psychological condition that causes numerous physical
      complaints for which no underlying physical problem can be identified. The disorder often
      lasts for several years and results in substantial functional impairment. The physical
      complaints most frequently involve chronic pain and problems with the digestive, nervous, and
      reproductive systems. Neither pharmacological nor psychosocial treatments for this disorder
      have been successful in suppressing symptoms. Cognitive behavioral therapy (CBT) is a
      treatment that focuses on maladaptive patterns of thinking and the beliefs that underlie such
      thinking. This study will examine the long-term effects of CBT on the physical symptoms,
      functioning, and health care utilization of people with somatization disorder.

      Participants in this open label study will be randomly assigned to receive either CBT
      supplemented with augmented standard medical care (ASMC) as indicated by a psychiatric
      consultation letter or ASMC alone. Participants assigned to CBT plus ASMC will receive CBT
      for 10 weeks. Somatic symptomatology, functional impairment, and health care costs will be
      assessed at study visits at baseline and Months 3, 9, and 15. The visits at Months 9 and 15
      will assess specifically the long-term efficacy of the treatment.
    

Intervention name(s): Cognitive Behavior Therapy; Psychiatric Consultation Letter
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Somatization Disorder; Multiple Medically Unexplained Symptoms; Cognitive Behavior Therapy; Mental Health
Effect of Carbamazepine and Oxcarbazepine on Serum Neuron-specific Enolase and S100B in Focal Seizures
Condition: Seizures, Focal
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 4

Summary: 
      The present study has been planned to assess the level of serum neuron-specific enolase (NSE)
      in focal seizures and its changes after antiepileptic therapy.
    

Detailed description: 
      Epileptic seizures can cause neuronal cell death, enhanced neurogenesis, axonal sprouting,
      dendritic changes, and reactive gliosis. Histopathological analyses have suggested that the
      initial insult and recurrent seizures contribute to the neuronal damage. Activation of mesial
      temporal structures is more likely to cause damage than that of other areas of brain;
      therefore, one of the consequences of prolonged seizures is selective neuronal loss in the
      hippocampus. The excitotoxic damage is considered the most important mechanism of injury but
      there is also evidence that programmed cell death contributes to neuronal damage.

      Various biomarkers of brain damage have been studied in the context of epilepsy and brain
      damage but most widely investigated biochemical biomarker is neuron-specific enolase (NSE).
      NSE is γγ-isoenzyme of enolase involved in glycolysis pathway. NSE originates predominantly
      from the cytoplasm of neurons and neuroendocrine cells. Neuronal damage and impairment of
      blood brain barrier integrity can be detected by the release of NSE into cerebrospinal fluid
      (CSF) and eventually into blood. NSE is therefore regarded as a marker of neuronal damage and
      prognosis in various disorders associated with cell damage in the central or peripheral
      nervous system.

      CSF and serum NSE levels obtained within first 48 hours were found to be elevated and
      correlated well with the duration of epilepsy and outcome of patients. Some studies have
      shown elevated NSE levels in temporal lobe epilepsy, after single tonic-clonic seizures, and
      status epilepticus. Literature review reveals that there is lack of data on serum NSE in
      focal seizures and there is no study on the effect of antiepileptic drugs on the level of
      serum NSE. So the present study has been planned to assess the level of serum NSE in focal
      seizures and its changes after antiepileptic therapy.
    

Intervention name(s): Carbamazepine; Oxcarbazepine
Intervention type(s): Drug; Drug
Intervention description(s): Carbamazepine will be started with a dose of 200 mg/day for one week and then increased to 400 mg/day for one week and then 600mg/day for next two weeks.; Oxcarbazepine will be started with 10mg/kg daily dose for one week followed by 15mg/kg daily for next one week and then will be increased to 20mg/kg for next two weeks.
Other intervention name(s): Tegretol; Oxetol
Intervention MeSH terms: Carbamazepine; Oxcarbazepine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neuron-specific enolase (NSE); Carbamazepine; Oxcarbazepine
Treating Sleep in Teens With ADHD
Condition: ADHD; Sleep
Study type: Interventional

Summary: 
      Sleep problems are common in adolescence and recognized as an international public health
      concern given their links to a range of adverse outcomes. Adolescents with
      attention-deficit/hyperactivity disorder (ADHD) experience more sleep problems than their
      peers, including delayed sleep onset, shorter sleep duration, poorer sleep quality, more
      sleep variability, and greater daytime sleepiness. Further, research conducted by the
      investigator's team has shown that sleep problems are strongly associated with - and causal
      contributors to - functional impairment in adolescents with ADHD, including increased mood,
      behavior, and academic problems. However, sleep problems are not currently addressed in any
      evidence-based treatment for adolescents with ADHD, and no study has evaluated an
      intervention targeting sleep problems in adolescents with ADHD. This is a notable gap in the
      field since consensus statements on sleep suggest that treating sleep problems may improve
      ADHD and associated impairments. Evidence-based cognitive-behavioral sleep interventions,
      including the Transdiagnostic Sleep and Circadian Intervention for Youth (TranS-C)
      intervention, are effective for improving sleep and associated impairments (e.g., attention,
      mood) in adolescents with sleep problems. However, these interventions have never been tested
      in adolescents with ADHD specifically. This will be the first to evaluate a
      cognitive-behavioral sleep intervention (TranS-C) in adolescents with ADHD who experience
      co-occurring sleep problems. This study will recruit 15 adolescents with ADHD and sleep
      problems to enroll in and complete an open trial of the TranS-C intervention to evaluate its
      feasibility, acceptability, and preliminary efficacy. Findings will provide key pilot data
      regarding treatment of sleep problems in adolescents with ADHD.
    


Intervention name(s): Transdiagnostic Sleep and Circadian Intervention for Youth (TranS-C)
Intervention type(s): Behavioral
Intervention description(s): TranS-C adopts a modular approach to reversing the psychosocial, behavioral, and cognitive processes maintaining sleep problems via 4 "cross-cutting" modules (introduced in the first session and included in every session thereafter), 4 core modules and 7 optional modules. TranS-C typically involves 6-8 individual, weekly 50-minute sessions.
Intervention model: Single Group Assignment
Intervention model description: This is a single group open trial.
Masking: None (Open Label)
Primary purpose: Treatment
A PhaseⅠb Study Evaluating Safety and Efficacy of C-CAR011 Treatment in B- NHL Subjects
Condition: B-cell Non-Hodgkin Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy
      of C-CAR011 therapy in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL).
    

Detailed description: 
      The study will include the following sequential phases: Screening, Pre- Treatment (Cell
      Product Preparation; Lymphodepleting Chemotherapy), Treatment and Follow-up
    

Intervention name(s): CD19-directed CAR-T cells
Intervention type(s): Biological
Intervention description(s): CD19-directed CAR-T cells single infusion intravenously at a target dose of 0.5-5.0 x 10^6 anti-CD19 CAR+ T cells/kg
Other intervention name(s): Anti-CD19 chimeric antigen receptor T cells (C- CAR011)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: B-cell Non-Hodgkin Lymphoma; Refractory; Relapsed
Evaluation of Cyclosporine Microemulsion and Tacrolimus on the Rate of New Onset Diabetes Mellitus in Kidney Transplantation Recipients
Condition: Kidney Transplant
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the impact of tacrolimus and cyclosporine
      microemulsion on glucose metabolism in kidney transplant recipients and the efficacy and
      safety in preventing organ rejection
    


Intervention name(s): Cyclosporine microemulsion; Tacrolimus
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cyclosporine; Tacrolimus; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Kidney transplant, adults, NODM, immunosuppressants