bioihbjkbjnl/mcl2 huggingface dataset:
Expressive Writing in Improving Quality of Life in Patients With Breast Cancer and Lymphedema
Condition: Breast Cancer; Fatigue; Lymphedema
MeSH terms: Breast Neoplasms; Lymphedema; Fatigue
Study type: Interventional

Summary: 
      RATIONALE: Expressive writing may help relieve symptoms and improve quality of life in breast
      cancer survivors with chronic lymphedema.

      PURPOSE: This clinical trial is studying expressive writing in improving the quality of life
      in women with breast cancer and lymphedema.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine if expressive writing improves quality of life (QOL) relative to the
           control condition in breast cancer survivors with chronic stage II lymphedema.

        -  To determine if expressive writing improves physical and psychological symptoms/outcomes
           (i.e., fatigue, psychological distress, activity level, confidence in body) relative to
           the control condition in breast cancer survivors with chronic lymphedema.

      Secondary

        -  To explore the influence of individual difference variables (dispositional optimism,
           emotional intelligence, and repressive coping) on outcomes associated with this
           intervention to include identification of subsets of individuals for whom expressive
           writing is most effective.

        -  To explore the influence of intrusive/avoidant thinking as a mediator between the
           intervention and outcomes of QOL and physical and psychological symptoms.

      OUTLINE: Patients are randomized to 1 of 2 treatment groups.

      Patients travel to the School of Nursing at Vanderbilt University or meet a team member in
      their home or another private location for an initial visit. Patients complete
      questionnaires, are measured for height and weight data, and arm fluid measurements.

        -  Expressive writing group: Twenty minutes a day, twice a week for 2 weeks, patients write
           about their deepest thoughts and feelings regarding their lymphedema and its treatment.

        -  Daily diary group (control): Twenty minutes a day, twice a week for 2 weeks patients
           write about how they manage their time .

      Patients complete quality-of-life questionnaires periodically.

      After completion of study, patients are followed at 1, 3, and 6 months.
    

Intervention name(s): expressive writing
Intervention type(s): Behavioral
Intervention description(s): four non-emotional writing assignments
Other intervention name(s): none noted
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: fatigue; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; lymphedema
Comparison of Plasma Caffeine Concentration After Oral Consumption of Caffeinated Beverages With Varied Bioactive Compounds in Healthy Volunteers
Condition: Plasma Caffeine Concentration
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, double blind, randomized, controlled, cross-over trial.

      The primary outcome is to quantify the incremental area-under-the-concentration-curve (iAUC)
      for plasma caffeine after oral consumption of caffeinated beverages with various bioactive
      compounds vs. caffeine alone, in 16 healthy volunteers

      Secondary outcomes are caffeine concentration at each time point from pre-dose baseline to
      3.5 hrs post-dose, peak caffeine concentration (Cmax), time to maximum caffeine concentration
      (Tmax) and return to baseline concentration (TBR) for plasma caffeine

      Other outcomes are ratings of physiological symptoms and mood, assessed using visual analog
      scales (VAS).

      Polyphenol food frequency questionnaire data at screening will be collected as a possible
      co-variate.
    


Intervention name(s): Beverage
Intervention type(s): Other
Intervention description(s): 16 oz (473.2 ml)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: caffeine; botanicals; beverage; mood
A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder.
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 2

Summary: 
      1. Primary Objective:

           To evaluate the dose-response relationship of tarafenacin on efficacy.

        2. Secondary Objectives:

             -  To compare 12 weeks' efficacy of different doses of tarafenacin to that of placebo
                in patients suffering from Overactive Bladder. .

             -  To compare the tolerability of different doses of tarafenacin to that of placebo in
                patients suffering from Overactive Bladder. .
    


Intervention name(s): Tarafenacin 0.2 mg; Placebo; Tarafenacin 0.4 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Capsule, qd, 12 weeks; Capsule, qd, 12 weeks; Capsule, qd, 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Overactive Bladder; Tarafenacin
Ultrasound and Mammography for Screening Breast Cancer in Chinese Women
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Early detection of breast cancer through screening has been a common practice in the United
      States and several European countries for decades.It is effective in reducing the mortality
      of breast cancer and improving the postoperative quality of life of patients. Mammography has
      been the standard imaging method for the screening, and in recent years, a supplemental
      ultrasound exam is also recommended.A prospective, multi-center, randomized trial is needed
      to define an optimal screening strategy that suits Chinese women and the socioeconomics of
      China.
    


Intervention name(s): mammography; ultrasound; mammography and ultrasound
Intervention type(s): Other; Other; Other
Intervention description(s): participants were screened by mammography alone every year; participants were screened by ultrasound alone every year; Participants were screened by both mammography and ultrasound every year
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: breast cancer; screening; mammography; ultrasound
Comparison of Tacrolimus 0.1% and Clobetasol 0.05% in the Management of Symptomatic Oral Lichen Planus
Condition: Oral Lichen Planus
MeSH terms: Lichen Planus, Oral; Lichen Planus
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical study is carried out to assess the efficacy of Tacrolimus and Clobetasol in
      symptomatic Oral Lichen Planus.
    


Intervention name(s): Tacrolimus 0.1%; Clobetasol 0.05%
Intervention type(s): Drug; Drug
Intervention description(s): This group was randomly allocated to receive topical Tacrolimus 0.1% for 3 consecutive weeks; This group was randomly allocated to receive topical Clobetasol 0.05% for 3 consecutive weeks
Intervention MeSH terms: Clobetasol; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phase 1/2 Study of TAK-850 Subcutaneous Injection in Healthy Adults
Condition: Influenza Infection
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of a single
      subcutaneous injection of TAK-850 as compared to intramuscular injection of TAK-850 in
      healthy Japanese adults
    

Detailed description: 
      The drug being tested in this study is called TAK-850. This drug is being tested to evaluate
      the safety and immunogenicity of a single subcutaneous injection as compared to a single,
      intramuscular injection.

      A total of 110 healthy participants (55 per group) will take part in this study.

      Each participant will be randomly (like flipping a coin) assigned to receive one of the
      following :

        -  A single injection of TAK-850, subcutaneously , or

        -  A single injection of TAK-850, intramuscularly.

      Participants will make up to 3 visits to the study site. Total duration of this study is 22
      days.
    

Intervention name(s): Subcutaneous injection of TAK-850; Intramuscular injection of TAK-850
Intervention type(s): Drug; Drug
Intervention description(s): TAK-850 0.5 mL, Subcutaneous injection; TAK-850 0.5 mL, Intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prevention
Added Value of N Acetyle Cysteine to Clomiphene Citrate in PCO
Condition: PCO
Study type: Interventional

Summary: 
      PCO is one of the factors associated with delayed conception
    

Detailed description: 
      In an attempt to induce ovulation Clomiphene citrate can be given in conjunction with N
      acetyle cysteine
    

Intervention name(s): Clomiphene plus metformin plus N acetyle cysteine in arm number 1; Clomiphene citrate plus metformin with chromium; clomiphene citrate plus metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral adminstration of clomiphene citrate plus metformin plus N acetyl cysteine or chromium; oral adminstration of clomiphene citrate plus metformin and chromium; oral adminstration of clomiphene citrate plus metformin
Intervention MeSH terms: Chromium; Metformin; Citric Acid; Sodium Citrate; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Women who will receive clomiphe citrate plus N acetyle cysteine rally in arm number 1 And women who will receive clomiphene citrate and chromoum in arm number 22
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Determination of Longus Colli Muscle Thickness by Ultrasonography
Condition: Pain Syndrome; Pain, Intractable; Complex Regional Pain Syndromes; Hyperhidrosis
MeSH terms: Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Hyperhidrosis; Syndrome; Pain, Intractable; Somatoform Disorders
Study type: Observational

Summary: 
      This study aims to assess the longus colli muscle thickness by ultrasonography in order to
      guide stellate ganglion blocks
    

Detailed description: 
      Stellate ganglion block is an interventional pain management procedure that is often
      performed for diagnostic and therapeutic purposes. It has long been performed with the
      guidance of fluoroscopy, and despite the increasing use of ultrasonography in recent years,
      fluoroscopy is still the gold standard method.

      In traditional fluoroscopic method, the needle is directed to the transverse process of the
      C6 vertebra, after touching the anterior tubercle (Chassaignac's tubercule) the needle is
      slightly withdrawn and following a negative aspiration, injection is performed.

      The ideal placement of the needle should be anterolateral to the longus colli muscle and deep
      to the prevertebral fascia. Further placement may cause intramuscular spread and superficial
      placement may cause injection in the carotid sheath or vascular structures. These are the
      most important reasons for clinical ineffectiveness. How far should the needle be withdrawn?
      Data is inconsistent in the literature.

      The primary aim of this study is to determine the distance from transverse process to longus
      colli muscles anterior border and from transverse process to carotid sheath's posterior
      border. Secondary aim is to investigate the relationship between longus colli muscle
      thickness and age, gender, height, weight, BMI and neck circumference.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers
      
Keywords: Stellate Ganglion; Longus Colli Muscle; Ultrasound
Effect of Antenatal Corticosteroids on Neonatal Morbidity.
Condition: Neonatal Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Hyaline Membrane Disease
Study type: Interventional

Summary: 
      It will be a randomized controlled trial. There will be two study groups. Study group 1 will
      be given dexamethasone while study group 2 will be given betamethasone. The control group
      will be given placebo.
    

Detailed description: 
      The study will be a double blind randomised controlled trial. There will be two study groups
      and one control group.

      The first study group will be the pregnant women at risk of late preterm birth that will
      receive antenatal corticosteroids in the form of intramuscular dexamethasone sodium
      phosphate.

      The second study group will be the pregnant women at risk of late preterm birth that will
      receive antenatal corticosteroids in the form of intramuscular betamethasone sodium
      phosphate.

      The control group will be pregnant women at risk of late preterm birth that will be given
      intramuscular water for injection.
    

Intervention name(s): Dexamethasone Sodium Phosphate Injection; Betamethasone Sodium Phosphate Injection (Medication); Water for injection
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dexamethasone sodium phosphate injection 12 mg X doses to be given 12 hours apart; betamethasone sodium phosphate injection12mg X 2 doses given 12 hours apart; Two doses of intramuscular injection of water for injection given 12 hours apart
Other intervention name(s): Pemadex; Juhel water for injection
Intervention MeSH terms: Dexamethasone; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Dexamethasone acetate; Betamethasone sodium phosphate; Dexamethasone 21-phosphate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised controlled trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Antenal corticosteroids; Late preterm delivery; Neonatal morbidity
Study of Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence
Condition: Colorectal Adenoma
MeSH terms: Adenoma; Recurrence
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Berberine hydrochloride is a conventional component in Chinese medicine. In recent years,
      anticancer activity of berberine hydrochloride have been explored. The aim of this study is
      to investigate the effect of berberine hydrochloride on the recurrence of colorectal
      adenomas.
    

Detailed description: 
      Colorectal adenomas are well-known to be precancerous lesions that develop into colorectal
      cancers on the basis of the adenoma-carcinoma sequence. The effects of screening for
      colorectal adenomas and removing precancerous lesions on the prevention of colorectal cancer
      have been established. Because of the high recurrence rates of colorectal adenomas in
      patients who have undergone polypectomy, the potential chemopreventive agents that may reduce
      the risk of colorectal adenoma recurrence need to be investigated.

      Berberine hydrochloride is a conventional component in Chinese medicine. In recent years,
      anticancer activity of berberine hydrochloride have been explored. The aim of this study is
      to investigate the effect of berberine hydrochloride on the recurrence of colorectal adenomas
      by conducting a randomized, placebo-controlled, prospective clinical.
    

Intervention name(s): Berberine hydrochloride; placebo
Intervention type(s): Drug; Drug
Intervention description(s): supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years; supplement of placebo two times per day for 2-3 years
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Vascepa to Accelerate Lipoprotein Uptake and Elimination
Condition: Lipid Disorder; Triglycerides High; Dyslipidemias
MeSH terms: Dyslipidemias; Lipid Metabolism Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase 1 pilot/feasibility mechanistic experiment to help clarify the
      mechanism of action of an EPA-rich fish oil preparation, icosapent ethyl, on lipid changes in
      statin-treated patients with residual triglyceridemia.
    

Detailed description: 
      This is a prospective randomized, controlled pilot/feasibility experiment in a small number
      of statin-treated patients with residual triglyceridemia assigned to chronic daily exposure
      to icosapent ethyl 4 g daily vs usual care to get preliminary data to ultimately design a
      definitive hypothesis-testing experiment to clarify the mechanism of action whereby icosapent
      ethyl alters lipoprotein kinetics. The formal statistical aim is to develop statistical
      parameters such as central tendency, dispersion, and distributional shape to design a robust
      hypothesis-testing study. The primary outcome is based around stable-isotope lipoprotein
      kinetics, specifically apolipoprotein B kinetics.
    

Intervention name(s): Icosapent Ethyl 1000 MG [Vascepa]
Intervention type(s): Drug
Intervention description(s): Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate.
Other intervention name(s): AMR101
Intervention MeSH terms: Eicosapentaenoic acid ethyl ester
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel, randomized, controlled mechanistic pilot/feasibility experiment focused on elucidating detailed mechanism of action for apolipoprotein turnover kinetics changes using intravenous infusions of stable isotopes in a clinical/translational metabolic unit.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
177Lu-PP-F11N in Combination With Sacubitril for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer
Condition: Thyroid Cancer, Medullary
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine the use of 177Lu-PP-F11N for imaging and therapy of
      patients with advanced medullary thyroid carcinoma (MTC). 177Lu-PP-F11N is a gastrin
      analogon, binding to cholecystokinin-2 receptors. This receptors show an overexpression on
      more than 90 % of medullary thyroid carcinomas.
    

Detailed description: 
      A phase 0 study (Lumed study part A) was already performed, showing low toxicity of
      177Lu-PP-F11N and tumor uptake in all patients. Co-injection of Physiogel (Gelofusin) showed
      insignificant reduction of kidney uptake and can therefore be omitted for a radionuclide
      therapy with 177Lu-PP-F11N. In this study, the effect of the NEP-1 inhibitor Sacuitril on the
      in-vivo stability of 177Lu-PP-F11N and the uptake, respectively radiation doses in MTC
      metastases and organs will be evaluated, using a cross-over design already used for the Lumed
      part A study. Each patient will receive two injections of 177Lu-PP-F11N, with and without
      additional medication with Sacuitril Imaging findings, acquired by SPECT/CT, will be compared
      to imaging with 68Ga-DOTATOC positron emission tomography (PET)/CT. The inclusion of 8
      patients is planned.
    

Intervention name(s): 177Lu-PP-F11N; Sacuitril
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N with and without co-medication with Sacuitril (100 mg Entresto) in each patient; Medication with Sacuitril (100 mg Entresto) additional to the injection of 177Lu-PP-F11N
Other intervention name(s): Radiopharmakon; Entresto
Intervention MeSH terms: Sacubitril and valsartan sodium hydrate drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Group 1 patients will receive first 177Lu-PP-F11N alone, second 177Lu-PP-F11N in combination with Sacuitril. Group 2 patients will first receive 177Lu-PP-F11N in combination with Sacuitril, second 177Lu-PP-F11N alone. Affiliation of patients to Groups 1 and 2 will be randomised.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Calcitonin; Medullary thyroid carcinoma; Peptide receptor radionuclide therapy; Gastrin; Cholecystokinin-2 receptor
Feasibility of Using Telepractice to Provide Modified Interaction Guidance.
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to determine the feasibility of using telepractice to provide
      Modified Interaction Guidance (MIG) to caregivers and their child with autism. MIG as an
      intervention to improve attachment for children with autism and their primary caregiver.
    

Detailed description: 
      The process objectives target focus on1) recruitment, 2) retention, 3) engagement with tools,
      4) time demand on dyads, and 5) eligibility criteria.

      The resource assessment objectives include: 1) equipment and internet accessibility 2)
      communication methods, and 3) timelines.

      The management assessment objectives address: 1) ethical standards, 2) researcher
      qualifications and 3) data storage and collection.

      Finally, when looking at the scientific assessment, the objectives relate to: 1) Is use of a
      concurrent multiple baseline single-subject design feasible with this population? 2)capturing
      dyad needs, 3) burden levels, and 4) safety protocols.

      This study will evaluate the above listed dimensions of feasibility using a embedded mixed
      methods approach that incorporates both a single-subject design and qualitative data gathered
      throughout the research process and post intervention individual interviews.
    

Intervention name(s): Modified Interaction Guidance
Intervention type(s): Behavioral
Intervention description(s): The main steps in the procedure are to have the family identify the primary concern they are facing, highlight the strengths that the family already has in place and expand on those strengths, convey/impart caregiving and societal norms, and offer other perspectives (McDonough, 2004). The goal of this therapy is to engage the family to take an active role in the construction of their overall treatment. The individualized treatment approach focuses and builds on existing strengths.
Intervention model: Single Group Assignment
Intervention model description: This study is a mixed methods feasibility study using a single-subject research design and qualitative description.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Modified Interaction Guidance