bioihbjkbjnl/mcl2 huggingface dataset:
Cognitive Behavioral Therapy for Insomnia With rTMS
Condition: Depression; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      Depression and insomnia occur together in a substantial number of patients. Transcranial
      magnetic stimulation (TMS) is an effective treatment for depression, but does not help
      insomnia symptoms in depressed patients. A form of cognitive behavioral therapy (CBT) has
      been developed that specifically helps with insomnia (CBT-I). The study team will give CBT-I
      to patients who are being treated with TMS for depression, who also have insomnia, to
      determine if it helps insomnia symptoms.
    


Intervention name(s): CBT-I (Cognitive Behavioral Therapy for Insomnia) with rTMS; Repetitive Transcranial Magnetic Stimulation
Intervention type(s): Behavioral; Device
Intervention description(s): Cognitive Behavioral Therapy for insomnia (CBT-I) with rTMS (repetitive Transcranial Magnetic Stimulation) will be performed as part of this study by the PI. This includes weekly, one hour sessions addressing sleep for 6 weeks.; Participants in this study will be undergoing repetitive transcranial magnetic stimulation (rTMS) for major depressive disorder as part of their clinical treatment. This involves magnetic stimulation with specific settings to a specific region of the brain to help treat depression. Treatment time ranges, but is around 30 minutes per session and occurs 5 days a week for 6 weeks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Staccato® Granisetron Single Dose PK
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Part A: Single Ascending Dose in Healthy Volunteers This study will assess single ascending
      oral doses of AZ-010 in a placebo-controlled, double-blind design. The planned AZ-010 doses
      to be studied are 0.5 mg, 1 mg, and 3 mg.

      Part B: Single Dose Crossover in Healthy Volunteers 2-period, 2-treatment open-label
      crossover design study assessing the pharmacokinetic profiles of AZ-010 (1 mg) and
      granisetron for IV injection (1 mg).
    

Detailed description: 
      This two-part study will assess the safety, tolerability, and pharmacokinetics (PK) of single
      ascending doses AZ-010 in healthy volunteers and will compare in a crossover design the
      safety and PK of a single dose of AZ-010 and IV granisetron.
    

Intervention name(s): 0.5mg AZ-010; 1mg AZ-010; 3mg AZ-010; AZ-010 1mg; IV Granisetron 1mg
Intervention type(s): Combination Product; Combination Product; Combination Product; Combination Product; Drug
Intervention description(s): Subject will receive a single inhaled dose (0.5mg) of AZ-010 or matching Staccato Placebo; Subject will receive a single inhaled dose (1.0 mg) of AZ-010 or matching Staccato Placebo; Subject will receive a single inhaled dose (3.0 mg) of AZ-010 or matching Staccato Placebo; 2-period, 2-treatment open-label crossover design; 2-period, 2-treatment open-label crossover design
Other intervention name(s): Staccato Placebo; Staccato Placebo; Staccato Placebo
Intervention MeSH terms: Granisetron
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Open Label Extension Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain
Condition: Back Pain Lower Back Chronic
MeSH terms: Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the long term safety of duloxetine in participants with
      Chronic Low Back Pain (CLBP).
    


Intervention name(s): Duloxetine
Intervention type(s): Drug
Intervention description(s): Administered orally
Other intervention name(s): Cymbalta; LY248686
Intervention MeSH terms: Duloxetine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Low Back Pain; CLBP
A Follow-up Assessment of Resistance to ABT-333 in Hepatitis C Virus (HCV)-Infected Subjects Who Have Received ABT-333 in ABT-333 Studies
Condition: HCV Infection
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this follow-up study is to evaluate the frequency and persistence of specific
      viral mutations in response to treatment with ABT-333 (dasabuvir).
    

Detailed description: 
      This Phase 2, multicenter study was conducted in HCV-infected participants who received
      ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT-333.
      Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or
      matching placebo in Study M10-351 Substudy 2 (NCT00696904; ABT-333 dosing duration was 2
      days) and Study M10-380 (NCT00851890; ABT-333 dosing duration was 28 days) were eligible.

      After receiving at least 1 dose of ABT-333 or placebo, subjects were assessed for
      participation in this rollover study and asked to review the informed consent. The day of
      study completion or early discontinuation from the prior ABT-333 clinical study served as the
      baseline assessment. If it was found that a participant received placebo during the previous
      ABT-333 clinical study, the sites were instructed to discontinue the participant from this
      study.

      This study included approximately monthly blood sample collection procedures for 48 weeks,
      and no treatment was provided during this time.
    

Intervention name(s): Blood sample collection only; ABT-333
Intervention type(s): Procedure; Drug
Intervention description(s): Approximately monthly collection of blood samples.; Previous treatment in prior ABT-333 studies.
Other intervention name(s): dasabuvir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: HCV Infection
Process and Outcomes of Horticultural Therapy for People With Disabilities
Condition: Mental Disorders, Severe; Intellectual Disability
MeSH terms: Intellectual Disability; Mental Disorders
Study type: Interventional

Summary: 
      Horticultural therapy (HT) "is the engagement of a client in horticulture activities
      facilitated by a trained therapist to achieve specific and documented treatment goals"
      (American Horticultural Therapy Association, 2012). People's interactions with plants,
      through goal-orientated horticultural activities in the form of active gardening, as well as
      the passive appreciation of nature, could be therapeutic to people with mental or
      intellectual disabilities in many ways (Eling, 2006; Parkinson, Lowe, & Vecsey, 2011). This
      study aims to conduct evaluation studies of HT group programmes for care home residents with
      severe mental illness.
    

Detailed description: 
      This is a randomized, single-blind, controlled study in which the outcomes of the
      horticultural therapy program is compared with a comparison group. Outcome measures were
      compared at Pre-intervention and post-intervention.
    

Intervention name(s): Horticultural therapy; Comparison
Intervention type(s): Behavioral; Other
Intervention description(s): A structured 8-session group therapy program, in which participants learn about plants, green spaces, plant-human interactions. During the program, the participants are guided by therapist to grow or take care of both indoor and outdoor plants, do small horticulture projects (like cooking, making drinks, herb projects).; 4 session of semi-structured and free engagement in activities of their choice. The activities that they could choose are mostly table-top activities which are solitary in nature, and does not require social interaction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: horticultural therapy; severe mental illness; care home residents
Pharmacological Modulations of Allergen-Specific Immunotherapy
Condition: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      There is mounting evidence that successful allergen immunotherapy (SIT) functions through the
      induction of different subset of Treg including Foxp3 positive cells, therefore additional
      strategies to enhance this property are highly attractive. Based on previous findings we
      assumed that combine allergen immunotherapy with non-specific treatments such as
      glucocorticosteroids and vitamin D3 as well as montelukast sodium treatment might enhanced
      allergen tolerance induction and improved clinical effectiveness of allergen-specific
      immunotherapy
    

Detailed description: 
      There is mounting evidence that successful allergen immunotherapy (SIT) functions through the
      induction of different subset of Treg including Foxp3 positive cells, therefore additional
      strategies to enhance this property are highly attractive. Since corticosteroids directly
      induce the development of an IL-10-synthesizing regulatory T-cell population (Tr1) and this
      effect can be greatly increased with vitamin D3 treatment we , we assumed that combine
      allergen immunotherapy with non-specific treatments such as glucocorticosteroids and vitamin
      D3 as well as montelukast sodium treatment might enhanced allergen tolerance induction and
      improved clinical effectiveness of allergen-specific immunotherapy, therefore we conducted
      the stud comparing the effect of glucocorticosteroid, glucocorticosteroid with vitamin D3 or
      montelukast sodium on early immunological and clinical effect of allergen-specific
      immunotherapy in asthmatic children.
    

Intervention name(s): prednisone, lactose; prednisone, colecalciferol, lactose; lactose; montelukast sodium; lactose
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy:
20mg prednisone+ 0.3mg lactose; Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy:
20mg prednisone + 1000j colecalciferol + 0.3mg lactose; Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy:
0.3mg lactose; Allergen immunotherapy (build-up phase)premedication with montelukast sodium. Children 6-14 years received 5 mg of montelukast and children > 14 years old received 10mg oral tablet once daily at bedtime; Allergen immunotherapy (build-up phase)premedication with 0,3mg lactose once daily at bedtime
Other intervention name(s): Miflonide; Pulmicort; Miflonide; Pulmicort; Miflonide; Pulmicort; Miflonide; Pulmicort; Miflonide; Pulmicort
Intervention MeSH terms: Cholecalciferol; Vitamin D; Prednisone; Budesonide; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: allergen immunotherapy premedication
Effect of Ramelteon on Smoking Abstinence
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled crossover study to test whether a
      medication called ramelteon (Brand Name: Remeron) will help smokers quit and whether it
      reduces sleep problems that smokers experience during a quit attempt.
    

Detailed description: 
      Ramelteon, an FDA-approved treatment for insomnia, is used to treat sleep problems (e.g.,
      specifically sleep onset latency) by enhancing melatonin receptor function. The investigators
      propose a randomized double-blind placebo-controlled crossover study.

      Fifty chronic smokers will complete a validated procedure for screening new medications. All
      subjects will receive 8mg ramelteon and placebo. The order in which ramelteon and placebo is
      received will be randomized across participants. This is a 6-week study consisting of two
      2-week medication phases separated by a 2-week washout. Each phase includes 1 week of ad
      libitum smoking (baseline) and 1 week of medication (ramelteon vs. placebo) plus transdermal
      nicotine patches while trying to abstain from smoking (quit assessment). Subjects will
      complete the same procedures during each study phase. Following completion of the study,
      participants will be offered standard smoking cessation treatment.

      For the duration of the study, subjects will be asked to keep sleep diaries and to wear an
      armband while sleeping, which provides objective indices of sleep duration and quality
      (SensewearPro® armband).

      The primary outcome will be the total number of days abstinent (out of 5) during each quit
      assessment period. Intermediate outcomes include sleep onset latency (self-report) and sleep
      efficiency (SensewearPro®).

      This study will provide information about the role of the melatonin system during brief
      abstinence and whether enhancing melatonin reduces abstinence-induced sleep problems that
      promote smoking relapse. Information obtained in this study may further establish the role of
      sleep disturbance in promoting smoking relapse.
    

Intervention name(s): Ramelteon; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Sugar Pill
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Ramelteon; Nicotine; Nicotine dependence; Insomnia; Tobacco Dependence
Spread of Muscle Hyperalgesia and Pain in a Low Dose NGF-induced Pain Model
Condition: Hyperalgesia; Healthy Subjects
MeSH terms: Hyperalgesia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to investigate and determine the time course and distribution on
      muscle hyperalgesia and muscle pain in a repeated, low dose NGF model. It is hypothesized
      that low dosages i.m injections of NGF are able to induce mechanical hyperalgesia and muscle
      soreness in a same manner (effect of duration) as for dosages previously used in NGF studies.
      Furthermore, it is also speculated if several injections of low dose NGF into the muscle
      combined are able to course immediate pain sensation and spreading of muscle
      hypersensitivity.
    

Detailed description: 
      Effects of pain responses, symptom development and pattern (time course and distribution)
      following 5 i.m low dose injections of NGF injected into the tibialis anterior muscle will be
      compared to a high dose i.m injection of NGF injected into the contralateral side in healthy
      pain-free subjects.
    

Intervention name(s): NGF
Intervention type(s): Drug
Intervention description(s): Intramuscular injection
Other intervention name(s): Beta-Nerve Growth Factor, Human
Intervention MeSH terms: Mitogens
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Muscle soreness; NGF-induced pain; Pain model; Long-lasting sensitization
Standardization of Chortoglyphus Arcuatus Allergenic Extract. Determination of Biological Activity in HEP Units
Condition: Rhinitis, Allergic, Seasonal; Conjunctivitis, Allergic
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Conjunctivitis; Conjunctivitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of the trial is to prove the therapeutic value of the product and enable an
      effective and safe dosage schedule to be recommended
    

Detailed description: 
      The skin testing procedure, based on the Nordic Guidelines is the reference method for the
      biological calibration of in-House Reference Preparations (IHRP). The method is not intended
      for routine testing of allergen extracts. The use of this procedure is the basis for the
      definition of biological activity units: "the activity of an allergen extract is 10,000
      Biological Units (BU) per ml (10 HEP per ml), when the extract provokes an specific skin
      reaction in the median sensitive patient with a wheal of the same size as a wheal provoked by
      a positive reference solution consisting of histamine 54.3 mmol/l (for example histamine
      dihydrochloride 10 mg/ml), when both solutions are administrated using the same technique
      (prick testing) on at least 20 individuals who are clinically allergic and cutaneously
      reactive to the allergen concerned".
    

Intervention name(s): Standardization of allergenic extract (Ch. arcuatus)
Intervention type(s): Other
Intervention description(s): Allergenic extract for cutaneous prick-test
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Allergen-extract; Standardization
Open-Label Extension Study of 23 mg Donepezil SR in Participants With Moderate to Severe Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of long-term administration
      of 23 milligram (mg) donepezil sustained release (SR) in participants with moderate to severe
      Alzheimer's disease. Participants who complete study E2020-G000-326 (NCT00478205) with no
      ongoing serious adverse events (SAEs) and no serious adverse drug reactions will be eligible
      to enter the open-label extension study.
    


Intervention name(s): Donepezil
Intervention type(s): Drug
Intervention description(s): Donepezil SR 23 mg once daily orally.
Other intervention name(s): Aricept
Intervention MeSH terms: Donepezil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Moderate-to-severe; Alzheimer's; Disease
Efficacy and Safety of S (+) - Ibuprofen in Osteoarthritis Pain
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of S (+) - ibuprofen compared to an
      active treatment for pain control in individuals diagnosed with osteoarthritis.
    


Intervention name(s): S (+) - Ibuprofen; Ibuvix® - ibuprofen
Intervention type(s): Drug; Drug
Intervention description(s): S (+) - Ibuprofen + placebo of Ibuvix®; Ibuvix® + placebo of S(+) - Ibuprofen
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Nonsteroidal anti-inflammatory; Pain; Ibuprofen; Inflammation; Anti-inflammatory; Pain control; Osteoarthritis; Pain relief; Enzyme Inhibitors
The Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation
Condition: Constipation; Chronic Idiopathic Constipation; Irritable Bowel Syndrome With Constipation
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Study type: Interventional

Summary: 
      Constipation is a common gastrointestinal motility disorder that is often chronic, negatively
      affects patients' daily lives. Constipation occurs when bowel movements become difficult or
      less frequent.This study is being done to study the effectiveness of the hydrogel capsule,
      CSP01, compared to the active control (carboxymethylcellulose) and placebo (non-medicine
      sugar pill), to relieve constipation among subjects with chronic idiopathic constipation
      (CIC) or with irritable bowel syndrome with constipation (IBS-C).
    


Intervention name(s): CSP01; Carboxymethylcellulose (CMC); Placebo
Intervention type(s): Device; Device; Device
Intervention description(s): Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.; Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.; Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
Intervention MeSH terms: Carboxymethylcellulose Sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
T-cell-immunity During Standard Radiotherapy in Localised Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      Immunological effects of radiotherapy have been described before, but not evaluated in a
      time-dependant manner.

      In order to identify a possible time frame for combination therapies, white blood cells are
      isolated of samples taken at different time points before during and after standard
      radiotherapy in patients with localised prostate cancer. The overall activity of the
      T-cell-system as well as tumor-specific T-cell-response are evaluated.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing standard radiotherapy for localised prostate cancer at the University
        Hospital of Tuebingen
      
Biospecimen description: 
      Peripheral blood mononuclear cells and serum are frozen and stored.
    
Keywords: localised; prostate cancer; radiotherapy; immunology
BTL-9000 Low Level Laser Therapy for the Waist Circumferential Reduction
Condition: Circumferential Reduction; Waist Circumferential Reduction
Study type: Interventional

Summary: 
      Prospective, two-arm, randomized study of the effectiveness of the BTL-9000 LLLT in achieving
      3 cm or greater average waist circumferential reduction in LLLT group of subjects relative to
      the base line and 1 cm or greater reduction relative to the average waist circumferential
      reduction of the Placebo group.
    

Detailed description: 
      Prospective, randomized, blinded, two-arms study of waist circumferential reduction following
      5 once-a-week treatments. One arm is the LLLT group of 25 subjects who are treated with the
      BTL-9000 LLLT and the other arm is the Placebo group of 15 subjects treated with the sham
      device. The objective of the study is to demonstrate the effectiveness of the BTL-9000 LLLT
      treatment in achieving average post-treatment waist circumferential reduction of 3 cm or
      greater across the waistline relative to the baseline assessment and of 1 cm or greater than
      the average waist circumferential reduction of the Placebo group.
    

Intervention name(s): BTL-9000 LLLT; sham BTL-9000 LLLT
Intervention type(s): Device; Device
Intervention description(s): Irradiation of adipocyte cells within the fat layer with BTL-9000 LLLT for the release of fat and lipids from these cells; Irradiation of adipocyte cells within the fat layer with sham BTL-9000 LLLT for the release of fat and lipids from these cells
Other intervention name(s): BTL-9000 LowLevel Laser Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low Level Laser Therapy; LLLT; Waist circumferential reduction