bioihbjkbjnl/mcl2 huggingface dataset:
The Efficacy of Periarticular Single Drug Compared With Multimodal Drug Injection in Controlling Pain After TKA
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the periarticular multimodal drug injection has
      more efficacy for controlling pain after TKA than single anaesthetic drug injection.
    

Detailed description: 
      Many studies have to determine the efficacy of periarticular multimodal drug injection or
      single local anaesthetic drug comparing with placebo for pain controlled in TKA. But in this
      study would like to determine which one of both drugs are more efficacy.

      In multimodal drug injection consist of levobupivacaine, morphine, ketorolac and epinephrine
      while single anaesthetic drug has levobupivacaine and epinephrine.
    

Intervention name(s): single anaesthetic drug; multimodal drug injection
Intervention type(s): Drug; Drug
Intervention description(s): inject periarticular tissue of the knee after implantation; inject periarticular tissue of the knee
Other intervention name(s): levobupivacaine; chirocaine; anaesthetic cocktail
Intervention MeSH terms: Anesthetics; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain control; periarticular injection; Total knee arthroplasty; levobupivacaine; multimodal drug injection
The Effect of an Experimental Gel Based on Acmella Oleracea Extract in Reducing Post-bleaching Tooth Sensitivity
Condition: Tooth Bleaching; Pain; Dentin Desensitizing Agents
MeSH terms: Dentin Sensitivity
Study type: Interventional

Summary: 
      This randomized, double-blind clinical trial aimed to evaluate the effect of an experimental
      gel containing 10% jambu extract (Acmella Oleracea) in reducing postoperative tooth
      sensitivity caused by bleaching with 35% hydrogen peroxide. The volunteers of this study were
      randomized into two different groups - GE (A. Oleracea extract at 10%) and GP (placebo). The
      dental elements of the GE received application of the experimental desensitizing gel on the
      buccal surfaces of the central incisors, lateral incisors, canines and upper and lower
      premolars, with a rubber cup in an active way, for 10 minutes. The GP group also received the
      application of a placebo gel (without active ingredient), under the same conditions described
      for the experimental gel. Subsequently, all groups underwent in-office bleaching treatment
      with 35% hydrogen peroxide.Post-bleaching sensitivity was collected through a form composed
      of the visual analogue scale (VAS). Color measurement was performed at two times: baseline
      (Ti) and one week after the 3rd bleaching session (Tf).
    


Intervention name(s): EG (Experimental A. Oleracea extract gel); GP (Gel placebo)
Intervention type(s): Other; Other
Intervention description(s): Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the EG received application of the experimental desensitizing gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active way, for 10 minutes.; Prior to bleaching treatment with 35% hydrogen peroxide, the GP group also received the application of a placebo gel (without active ingredient), under the same conditions described for the experimental gel.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Safety and Pharmacokinetics of Ataluren in Participants From ≥6 Months to <2 Years of Age With Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD)
Condition: Nonsene Mutation Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate safety, tolerability, and pharmacokinetics (PK) in male
      children with nmDMD aged ≥6 months to <2 years treated daily for 24 weeks with orally
      administered ataluren 10, 10, and 20 milligrams/kilogram (mg/kg) (morning, mid-day, and
      evening dose, respectively).
    

Detailed description: 
      Participants who complete the 24-week treatment period in this study will be offered
      participation to a follow-up extension period for at least 52 weeks from the date of first
      administration of ataluren in this parent study.
    

Intervention name(s): Ataluren
Intervention type(s): Drug
Intervention description(s): Ataluren will be administered as per the dose and schedule specified in the arm.
Other intervention name(s): PTC124
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact Advanced Recovery® for Radical Cystectomy (RC) Patients: a Pilot Study
Condition: Bladder Cancer; Radical Cystectomy; Urinary Bladder Neoplasms; Surgery
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is determine if using Impact Advanced Recovery® before and after RC
      surgery helps reduce surgical complications.
    

Detailed description: 
      Radical cystectomy (RC) is the removal of the entire bladder and nearby organs that may
      contain cancer cells. It is a major surgery that can lead to breakdown of proteins in the
      body and a decreased immune response, both of which increase the risk of illness and death.
      Poor nutrition status before RC surgery is linked to a higher rate of death after surgery.
      Therefore, it is important to eat a balanced diet before and after RC surgery to avoid
      negative outcomes.

      Studies show that patients who drink a nutritional supplement that may enhance the immune
      system before and after gastro-intestinal surgery may have fewer infections and shorter
      hospital stays after surgery. Patients with cancer of the colon/rectum, stomach, and pancreas
      who drank a similar immune-enhancing nutritional supplement before and after surgery also had
      fewer infections.

      The purpose of this study is to attain pilot data for a larger trial.
    

Intervention name(s): Boost Plus®; Impact Advanced Recovery®
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: nutritional supplement; immune system; RC surgery
Effect of Aromatherapy on Postoperative Nausea, Vomiting
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effect of the aromatherapy with lavender, rose or
      ginger essential oils on nausea, vomiting and postoperative quality of recovery scores in
      patients with postoperative nausea and vomiting.
    

Detailed description: 
      Postoperative Nausea and Vomiting (PONV) relief is still challenge for the anesthesiologist.
      Pharmacological therapies is also cornerstone for treatment of PONV. Although future
      researches are needed, there is some proofs about the aromatherapy could provide an
      inexpensive, noninvasive and effective treatment for PONV.
    

Intervention name(s): Lavender Aromatherapy; Rose Aromatherapy; Ginger Aromatherapy; Placebo Aromatherapy
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): the two drops of lavender essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes.; the two drops of rose essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes.; the two drops of ginger essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes.; the two drops of pure water will be dropped into the gauze and the patient will inhale it for 5 minutes
Other intervention name(s): Aromatherapy with lavender essential oil; Aromatherapy with rose essential oil; Aromatherapy with ginger essential oil; Aromatherapy with pure water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative Nausea and Vomiting; Aromatherapy; Quality of Health Care
Evaluation of the Effect of Pramlintide on Satiety and Food Intake
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single center, randomized, blinded, placebo-controlled, two-period, cross-over
      study to evaluate the effect of pramlintide on satiety and food intake in normal-weight and
      obese non-diabetic subjects and in insulin-treated subjects with type 1 and type 2 diabetes.
    


Intervention name(s): Pramlintide acetate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.; placebo injection will be supplied in 5-mL multidose glass vials with a rubber stopper
Intervention MeSH terms: Pramlintide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Efficacy and Safety of Nasal Glucagon for Treatment of Hypoglycemia in Adults
Condition: Diabetes Mellitus, Type 1
MeSH terms: Hypoglycemia; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy, pharmacokinetics (PK), pharmacodynamics
      (PD), and safety of 3 milligrams (mg) glucagon (glucagon nasal powder) administered nasally
      compared with commercially available glucagon given by intramuscular injection.
    

Detailed description: 
      Each glucagon dosing visit was conducted after an overnight fast of at least 8 h with a
      starting plasma glucose >= 90 mg/dL. Hypoglycemia was induced by an intravenous (IV) infusion
      of regular insulin diluted in normal saline during the clinic visit. Five minutes after
      stopping the insulin infusion (once the plasma glucose was <60 mg/dL), participants were
      treated with either a 3 mg glucagon dose nasally or 1 mg of glucagon administered by
      intramuscular (IM) injection.

      After a wash-out period of 7 days or more, participants returned to the clinic and the
      procedure repeated with each participant crossed over to the other treatment. As such, each
      participant underwent two episodes of insulin-induced hypoglycemia in random order and
      received glucagon nasal powder during one episode and commercially available glucagon
      (GlucaGen, Novo Nordisk) by IM injection during the other episode.
    

Intervention name(s): Nasal Glucagon; Intramuscular Glucagon
Intervention type(s): Drug; Drug
Other intervention name(s): AMG504-1; LY900018; GlucaGen HypoKit
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study was to compare the renoprotective effect of a long acting calcium
      antagonist (nisoldipine) with an angiotensin converting enzyme inhibitor (lisinopril)in type
      1 diabetic patients with diabetic kidney disease. In total, 51 patients were randomised to
      treatment with one of these drugs for 4 years. Changes in kidney function, blood pressure and
      urinary excretion of albumin were measured every 6 months
    


Intervention name(s): nisoldipine; lisinopril
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lisinopril; Nisoldipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Resistance Training in Elderly
Condition: Sarcopenia; Atrophy; Aging
MeSH terms: Sarcopenia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In the present study the investigators aim to determine whether protein supplementation can
      augment the response to a 12 week resistance training program in healthy elderly men.
    


Intervention name(s): protein drink; Resistance training
Intervention type(s): Dietary Supplement; Behavioral
Intervention description(s): 250 ml protein hydrolysate solution; 12 weeks resistance training, 3 days per week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: resistance training; protein supplementation; hypertrophy
Pharmacokinetics of Voxilaprevir in Adults With Normal Renal Function and Severe Renal Impairment
Condition: HCV Infection
MeSH terms: Hepatitis C; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the pharmacokinetics, safety, and
      tolerability of voxilaprevir (formerly GS-9857) in participants with severe renal impairment
      and matched healthy control participants.
    


Intervention name(s): Voxilaprevir
Intervention type(s): Drug
Intervention description(s): 100 mg tablet administered orally
Other intervention name(s): GS-9857
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Feasibility Study of Group Metacognitive Therapy Versus Mindfulness Meditation Therapy
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The study will examine the effectiveness of group metacognitive therapy in comparison with
      group meditation therapy, in patients with Generalised Anxiety Disorder. Individuals will be
      randomly assigned to either meditation or metacognitive therapy and undergo 8 group therapy
      sessions of their respective treatment condition.
    


Intervention name(s): Group Metacognitive Therapy; Mindfulness Meditation Therapy
Intervention type(s): Behavioral; Behavioral
Other intervention name(s): MCT; MMT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Metacognitive therapy; mindfulness meditation therapy; group therapy; generalized anxiety disorder; Group Based Metacognitive Therapy; Group Based Mindfulness Meditation Therapy
Microbiome in Lung Cancer and Other Malignancies
Condition: Lung Cancer; Cancer; Malignancy
MeSH terms: Lung Neoplasms; Neoplasms
Study type: Observational

Summary: 
      To characterize the fecal, skin, nasal and oral microbiome and metabolome in patients with
      lung cancer and other malignancies, and correlate to treatment response and toxicities of
      various therapies including immunotherapy, chemotherapy and targeted therapy, etc.
    

Detailed description: 
      Patients will be asked to provide nasal, oral and skin swabs, as well as stool samples during
      their regular clinic visits, at the baseline before desired therapy is given, and at the time
      when treatment is changed due to either disease progression or unbearable toxicities leading
      to treatment stop/change. If treatment stop/held is due to toxicities, a 3rd set of samples
      will be collected when toxicities reduce to less than grade 1. The samples will be subjected
      to DNA extraction followed by 16S rRNA and/or shotgun sequencing metagenomic analysis. The
      data will be correlated to clinical response from treatments, toxicities, clinical data (use
      of antibiotics, PPIs, lab parameters, etc.) and tissue genetic/immunological characteristics
      (mutations, PDL1 expression, etc.) for review of response. This is not data to be used for
      treatment of these subjects.
    

Intervention name(s): Nasal Swab; Oral Swab; Stool Collection; Microbiome analysis; DNA Banking; Skin Swab
Intervention type(s): Procedure; Procedure; Other; Genetic; Genetic; Procedure
Intervention description(s): The swab is removed from packaging, moistened with sterile water if needed to prevent any discomfort to the participant. The swab is gently inserted less than one inch into the anterior nare (nostril) until resistance is met at turbinate. Then it is rotated several times against nasal wall and repeated in other nostril using the same swab.; The swab is removed from packaging, moistened with sterile water if needed to prevent any discomfort to the participant. The swab is gently rubbed along the inside of the participant's cheek for 5-10 seconds.; A stool collection kit will be sent home with each participant. It will include instructions on how to collect the stool specimen and how to return the kit.; Study of microbial communities found in and on the human body.; Secure, long term storage of an individual's genetic material.; Gentle rubbing of the swab will be applied to the skin on the dorsal part of the hand.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All individuals, meeting eligibility requirements will be eligible to participate in the
        study by providing samples during times of routine care for lung cancer and other
        malignancies.
      
Biospecimen description: 
      Bacterial DNA will be isolated from oral, skin, and nasal swabs, as well as stool samples.
      The extracted DNA will be subsequently used for microbiome analysis.
Randomized Controlled Double Blind Trial of Short vs Long Acting Dihydrocodeine in Chronic Non-malignant Pain
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      We wish to compare the effect of long acting vs short acting opioids in chronic non-malignant
      pain. The study opioid is Dihydrocodeine Continus and Dihydrocodeine 30 mg tablets. We
      measure pain relief, health related quality of life, sleep, breakthrough pain and depression
      with validated questionnaires to compare the two treatment arms.

      Hypothesis: The pain relief will be better and more stable with long acting opioids. Quality
      of sleep, breakthrough pain and quality of life will also be improved with long acting
      dihydrocodeine.
    


Intervention name(s): Dihydrocodeine
Intervention type(s): Drug
Intervention description(s): Group 1: 2* 60 mg dihydrocodeine long acting + up to four placebo short action
Group 2: 3* 60 mg dihydrocodeine long acting + up to six placebo short action
Group 3: 4* 60 mg dihydrocodeine long acting + up to eight placebo short action
Group 4: 2 placebo for long acting + up to 4*30 mg dihydrocodeine short acting
Group 5: 3 placebo for long acting + up to 6*30 mg dihydrocodeine short acting
Group 6: 3 placebo for long acting + up to 8*30 mg dihydrocodeine short acting
Intervention MeSH terms: Dihydrocodeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: dihydrocodeine; opioids, long acting; opioids, short acting; Chronic pain; non-malignant pain
Functional Organ Preservation Surgery
Condition: Organ Preservation
Study type: Interventional

Summary: 
      This is a prospective randomized controlled trial comparing functional organ preservation
      surgery (FOPS) vs. radiotherapy or chemoradiotherapy as the first treatment modality for
      patients with head an neck squamous cell carcinoma arising in the oropharynx, larynx and
      hypopharynx. This study has a hypothesis that the FOPS is an effective treatment strategy to
      preserve the organ function without compromising oncologic safety and survival.
    

Detailed description: 
      This prospective study compare the following items between two groups:

        -  Functional outcomes: laryngeal, pharyngeal, and quality of life

        -  Oncological outcomes: survivals, locoregional controls

        -  Combined imaging and molecular biomarkers with follow-up data

      The functional organ preservation surgery (FOPS) is defined as a surgery preserving the
      laryngeal or pharyngeal function regardless of open or transoral route. The FOPS may include:

        -  Radical tonsillectomy or other oropharyngeal resection

        -  Partial laryngectomy or pharyngectomy

        -  Transoral laser microresection

        -  Transoral robotic surgery (TORS)

        -  Reconstructive surgery may be combined with primary resection

        -  Neck dissection may be indicated in some patients

        -  Postoperative radiotherapy or chemoradiotherapy may be indicated in some patients
           according to their pathologic reports.

      The standard concurrent chemoradiotherapy (CRT) is generally used but radiotherapy (RT) alone
      may be indicated for some patients under tumor-board discussion. The salvage surgery may be
      indicated for patients with residual or recurrent diseases after CRT or RT.
    

Intervention name(s): FOPS; CRT
Intervention type(s): Procedure; Radiation
Intervention description(s): Functional organ preservation (FOPS) as a first-line treatment modality
Postoperative RT or CRT may be included for the patients of this group.; Concurrent chemoradiotherapy as a first-line treatment modality
Salvage surgery may be applied for the patients with persistent or recurrent cancers after RT or CRT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Laryngeal and pharyngeal preservation, survivals
Exemestane Plus Goserelin in Treating Premenopausal Women With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using
      exemestane plus goserelin may fight breast cancer by reducing the production of estrogen.

      PURPOSE: Phase II trial to study the effectiveness of exemestane and goserelin in treating
      premenopausal women who have metastatic breast cancer that has not responded to previous
      tamoxifen.
    

Detailed description: 
      OBJECTIVES: I. Determine the efficacy of exemestane and goserelin in premenopausal women with
      hormone receptor positive metastatic breast cancer after tamoxifen failure. II. Determine the
      toxicity of this regimen in these patients. III. Determine the hormonal profile of patients
      treated with this regimen. IV. Determine the predictive value of HER-2, epidermal growth
      factor receptor, and estrogen receptor for response in patients treated with this regimen.

      OUTLINE: Patients receive oral exemestane daily on days 1-28 and goserelin subcutaneously on
      day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable
      toxicity.

      PROJECTED ACCRUAL: A total of 22-40 patients will be accrued for this study.
    

Intervention name(s): exemestane; goserelin acetate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Exemestane; Goserelin
Primary purpose: Treatment
Keywords: stage IV breast cancer; recurrent breast cancer