bioihbjkbjnl/mcl2 huggingface dataset:
Health Promotion for Women With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Women with chronic disabling conditions such as fibromyalgia syndrome (FMS) must manage a
      wide variety of disease-related, intrapersonal, and environmental demands to maintain their
      health and quality of life. Engaging in health-promoting behaviors is one strategy
      recommended to manage disease symptoms and enhance quality of life (USDHHS, 2000). The
      purpose of this four-year study is to refine and test a theoretically and empirically based
      intervention to promote the health and well being of women with the chronic disabling
      condition of fibromyalgia. We hypothesize that women who participate in the "Lifestyle
      Counts" Intervention will report more greater self-efficacy for health behaviors, more
      frequent health behaviors and more positive health and quality of life than women in the
      comparison group.
    

Detailed description: 
      This wellness intervention, originally developed and tested in a randomized clinical trial of
      women with MS (N=113), resulted in significant improvements in self-efficacy, health
      behaviors and improvements in pain, social functioning, mental health and emotional
      role-functioning. The specific aims of this study are to examine the effects of the adapted
      wellness intervention on self-efficacy, resources, barriers, health behaviors and health
      outcomes for women with fibromyalgia.

      A sample of 160 women with FMS will be recruited to participate in a randomized clinical
      study to determine the effects of this wellness intervention that includes an eight week
      health promotion/behavior change component and 3 months of follow-up phone support. Content
      regarding stress management, lifestyle adjustment, physical activity, nutrition and women's
      health issues will be presented with an emphasis on the unique adaptations and associated
      skills required to empower women with the tools for exercising personal control over their
      health behaviors. The effects of the intervention on outcome variables will be assessed over
      an 8-month period with measurements at baseline, 2 months (immediately after the
      educational/skill-building component), 5 months (after 3 months of phone support) and at 8
      months.
    

Intervention name(s): Lifestyle Counts; Attention Control
Intervention type(s): Behavioral; Other
Intervention description(s): 8 weeks of classes focused on health behavior change, individualized goal setting and 3 months of follow-up phone support; 8 weeks of classes on general health information topics followed by 3 months of phone calls to solicit questions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Women; Fibromyalgia Syndrome; Health Behaviors; Quality of Life
ProSat - Effect of Probiotics on Satiety
Condition: Obesity; Appetite Regulation
Study type: Interventional

Summary: 
      The aim of the ProSat study is to examine the effects of a probiotic capsule containing one
      of two doses (low and high dose) of Lb. Casei on subjective appetite sensation, ad libitum
      energy intake, and appetite hormone response in a single meal test and to determine whether
      the acute effects persist after daily supplementation of the probiotic capsule.
    


Intervention name(s): probiotic; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): One capsule per meal test (high dose or low dose); 1 capsuel every morning
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Improved Language Acquisition With Levodopa
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether the non-daily administration of levodopa is
      effective in boosting semantic language acquisition in healthy subjects.
    

Detailed description: 
      Our prior work using a between-subject design shows that daily administration of
      d-amphetamine or the dopamine precursor levodopa over the course of five days markedly
      improves word learning success in healthy subjects. In this randomized, placebo-controlled,
      double-blind clinical trial, we probe whether the effect can be replicated using a
      within-subject design, with administration of levodopa and placebo on alternate days for a
      total period of 10 days.

      The expected scientific results will strengthen the basis for transferring neuromodulatory
      interventions from the laboratory to stroke patients with language dysfunctions. Because of
      the heterogeneity of stroke patients, only a within-subject design can be used to probe the
      effects of pharmacological adjuncts to language therapy.
    

Intervention name(s): levodopa
Intervention type(s): Drug
Intervention MeSH terms: Levodopa
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: language acquisition; plasticity; stroke recovery; associative learning
Magnifying NBI Endoscopy for Gastric Condition
Condition: Gastritis H Pylori
MeSH terms: Gastritis
Study type: Observational

Summary: 
      Recently, the improved resolution with standard endoscopy allows the close observation of
      highly inflamed gastric mucosa without a magnifying view. In a previous study, the
      investigators established the endoscopic classification of H. pylori-infected stomach by
      non-magnifying standard endoscopy. One normal RAC pattern and three types of abnormal
      patterns were observed. Overall diagnostic accuracy for predicting H. pylori-infection was
      91.6%. However, there is no comparison study predicting H. pylori-infection and precancerous
      gastric lesions between standard and magnifying endoscopy.
    

Detailed description: 
      The investigators aimed to evaluate the diagnostic efficacies of non-magnifying standard
      endoscopy for predicting H. pylori-infection status and precancerous gastric conditions,
      compared to magnifying NBI endoscopy
    

Intervention name(s): Magnifying narrow-band imaging endoscopy
Intervention type(s): Other
Intervention description(s): During endoscopy, gastric mucosal patterns would be examined by magnifying narrow-band imaging.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All of the patients underwent gastroscopy for peptic ulcer, gastric cancer screening in a
        single academic hospital.
      
Biospecimen description: 
      Biospecimen would be obtained for urease test (commercial name: CLOtest) and pathological
      analysis.
Prednisolone in the Treatment of Withdrawal Headache in Probable Medication Overuse Headache
Condition: Headache
MeSH terms: Headache Disorders, Secondary; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether prednisolone is more effective than placebo
      in the first six days after initiation of medication withdrawal therapy for a medication
      overuse headache. Another purpose is to study whether patients followed by a neurologist 1
      year after withdrawal do better than patients followed by a general practitioner.
    

Detailed description: 
      Data published BoeMG,Mygland A,Salvesen R; Neurology 2007 Jul 3;69(1):26-31
    

Intervention name(s): prednisolone
Intervention type(s): Drug
Intervention description(s): Prednisolone 60mg day 1 and 2 , 40mg day 3 and 4 , 20mg day 5 and 6
Other intervention name(s): Prednison, prednisolon
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: migraine; analgesics; tension type headache
Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      Our primary hypothesis is that Roflumilast (500 μcg, once daily) will significantly decrease
      surrogate markers of bone metabolism and early cardiovascular disease in individuals with
      moderate to severe airflow obstruction and a chronic bronchitis phenotype.
    

Detailed description: 
      Study participants will be given Roflumilast 500 micrograms daily for 30 days. At baseline,
      prior to drug administration, blood samples will be collected for analysis of markers of bone
      metabolism (C-terminal telopeptide of Type I Collagen (CTx), Amino-terminal Propeptide of
      Type-1 Procollagen (P1NP) and participants will undergo measurement of endothelial function
      with measurement of brachial flow mediated dilation. After completion of one month of
      Roflumilast therapy, participants will have a repeat blood collection for measurement of CTx
      and P1NP and repeat measurement of brachial flow mediated dilation testing.
    

Intervention name(s): Roflumilast
Intervention type(s): Drug
Other intervention name(s): Daxas; Daliresp
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Roflumilast; COPD
Pharmacokinetics and Pharmacodynamics Study of BCD-066 Compared to Aranesp® in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized double-blind crossover study of pharmacokinetics, pharmacodynamics and
      safety of BCD-066 (darbepoetin alfa manufactured by CJSC BIOCAD, Russia) and Aranesp® (Amgen
      Europe B.V., Netherlands) in healthy volunteers. The purpose of the study is to demonstrate
      the equivalence of pharmacokinetics, pharmacodynamics and safety parameters after single
      subcutaneous or intravenous injection. Each drug will be administered to each volunteer at a
      dose of 1 µg per kilogram as a single subcutaneous or intravenous injection with an interval
      of at least 25 days.
    


Intervention name(s): Darbepoetin alfa
Intervention type(s): Drug
Other intervention name(s): Aranesp; BCD-066
Intervention MeSH terms: Darbepoetin alfa
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: darbepoetin alfa; pharmacokinetics; pharmacodynamics; healthy volunteers
Using BETTER Model Sexual Problems in Breast Cancer
Condition: Sexuality; Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Breast cancer and its treatments such as mastectomy, chemotherapy, radiotherapy, hormonal
      therapy cause many side effects such as scar, problems with body perception and sexual
      problems. Sexual concerns lead to significant emotional distress, including
      sadness/depression, issues related to personal appearance, stigma, and negative impacts on
      personal relationships, intimacy and sexuality all of which reduce the quality of life. This
      experimental type of research is conducted within the framework of the BETTER model to
      evaluate the impact of counselling programme on sexuality issues that patients with breast
      cancer experience.
    

Detailed description: 
      Methods: The sampling consists of 60 female participants who volunteered to participate in
      the study. Face to face interviews are held with the female participants based on the
      Information Forms and Female Sexual Function Index (FSFI)", "EORTC QLQ-BR23 Quality of Life
      Questionnaire", "Center for Epidemiologic Studies Depression Scale (CES-D)", "Body Cathexis
      Scale (BCS)" and "BETTER Model". Counselling programme of the women in the intervention group
      is held in four sessions one week apart and these women are provided with a counselling
      booklet accompanied by a CD. The scales are re-applied one month after the last session. In
      the control group, the women are left under routine hospital control after the scales are
      applied. The scales are re-applied to the control group after one month.
    

Intervention name(s): Counselling
Intervention type(s): Other
Intervention description(s): o An appointment was made with the women in the experimental group at a time when they were available and a suitable environment was arranged in the hospital. The counselling programme of the experimental group was conducted in four sessions one week apart. In addition, each woman in the experimental group was given a counselling booklet and compact disc. The interviews lasted between 15- 45 minutes. The topics of interest among women were noted in the interviews and after the information on the subject was received, feedback was given to the relevant woman through a phone call.
Other intervention name(s): education
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: pre evaluation-final evaluation, control group work
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: breast cancer; sexuality; better model; nursing care
ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
Condition: Primary Biliary Cholangitis
MeSH terms: Cholangitis; Liver Cirrhosis, Biliary
Study type: Interventional
Phase: Phase 3

Summary: 
      A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy
      of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response
      to or intolerance to ursodeoxycholic acid (UDCA)

      The participants might enter the ongoing open-label safety study (NCT03301506) following this
      double-blind study.
    

Detailed description: 
      Primary:

        -  To evaluate the safety and effect on cholestasis of two seladelpar regimens (5 mg/day
           titrated to 10 mg/day and 10 mg/day) over 52 weeks of treatment compared to placebo

      Key Secondary:

        -  To evaluate the effect of seladelpar on normalization of alkaline phosphatase (AP)
           levels

        -  To evaluate the effect of seladelpar on pruritus
    

Intervention name(s): seladelpar 5-10 mg; seladelpar 10 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Seladelpar 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety study. Subjects will continue the seladelpar dose (5 or 10 mg) received during the double-blinded study; Seladelpar 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label safety study. Subjects will continue the seladelpar dose (10 mg) received during the double-blinded study; One capsule daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety study. Subjects on placebo will be re-randomized to initiate seladelpar at 5 or 10 mg once daily
Intervention MeSH terms: Seladelpar
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PBC; Primary Biliary Cholangitis (PBC)
ALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced Abstinence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 3

Summary: 
      VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to
      abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL.
      This Phase 3B trial was designed to evaluate the efficacy and safety of VIVITROL versus
      placebo. Injections were administered to patients in whom abstinence was enforced by a period
      of inpatient hospitalization of 7 to 21 days.
    

Detailed description: 
      The study consisted of 2 parts, Part A and Part B. Part A was a double-blind,
      placebo-controlled assessment of safety and efficacy of VIVITROL versus placebo for 3 months.
      Part B was an open-label extension to assess longer-term safety, durability of effect, and
      health economics of VIVITROL when administered for up to 9 additional months.
    

Intervention name(s): VIVITROL 380 mg; Placebo for VIVITROL 380 mg
Intervention type(s): Drug; Drug
Intervention description(s): Administered via IM injection once every 4 weeks.; Administered via IM injection once every 4 weeks.
Other intervention name(s): naltrexone for extended-release injectable suspension; Medisorb naltrexone
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Addiction; Alcoholism; Inpatient detoxification
A Pharmacokinetic Study Comparing the Liraglutide Injection (RD12014) and Victoza® in Healthy Chinese Subjects
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetics similarity between the liraglutide injection (RD12014)
      produced by Sunshine Lake Pharma Co., Ltd. and liraglutide injection (Victoza®) produced by
      Novo Nordisk Pharmaceutical Co., Ltd for single dose in healthy male subjects, as well as to
      evaluate the similarity of the safety and immunogenicity between RD12014 and Victoza ® in
      healthy subjects.
    


Intervention name(s): Liraglutide injection,RD12014; Liraglutide injection,Victoza
Intervention type(s): Drug; Drug
Intervention description(s): single dose, s.c. injection; single dose, s.c. injection
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of 9MW0813 in Subjects With Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional
Phase: Phase 1

Summary: 
      A multicenter, randomized, double-blind, parallel-controlled phase I trial comparing the
      safety, pharmacokinetics and efficacy of 9MW0813 and aflibercept (EYLEA®) after a single dose
      in patients with diabetic macular edema (DME).
    

Detailed description: 
      This is a multi-center, randomized, double-blind, parallel controlled Phase I clinical trial.

      The primary objective is to compare the safety of a single intravitreal injection (IVT) of
      9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) in DME patients.

      The secondary objectives are to comparing the pharmacokinetic profile, immunogenicity and
      efficacy of a single intravitreal injection (IVT) of 9MW0813 injection and aflibercept
      intraocular injection solution (EYLEA®) in DME patients.
    

Intervention name(s): 9MW0813; Aflibercept
Intervention type(s): Drug; Drug
Intervention description(s): The active ingredient of 9MW0813 injection is recombinant human vascular endothelial growth factor receptor-antibody fusion protein.
One dose(2mg) of the drug will be injected intravitreously.; Aflibercept (trade name: Eylea®/EYLEA®) is an anti-VEGF drug developed by Regeneron/Bayer. It is a fusion protein of human VEGFR1 and VEGFR2 extracellular domains and human immunoglobulin Fc segment genes.
One dose(2mg) of the drug will be injected intravitreously.
Other intervention name(s): Eylea®
Intervention MeSH terms: Aflibercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: aflibercept; biosimilarity; safety; pharmacokinetics; pharmacodynamics
VATS Versus Thoracotomy for Pulmonary Hydatid Disease
Condition: Pulmonary Hydatid Cyst
MeSH terms: Echinococcosis; Echinococcosis, Pulmonary
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the efficacy and safety of minimally invasive surgery
      and compare the outcomes with patients undergoing thoracotomy in treatment of Pulmonary
      Hydatid Cyst.

      Disease : pulmonary hydatid cyst.

      Intervention:

        -  Group 1 : VATS approach.

        -  Group 2 : thoracotomy approach.
    

Detailed description: 
      After being informed about the study and the approach, all patients giving written informed
      consent to determine eligibility for study entry.
    

Intervention name(s): VATS approach; Thoracotomy approach
Intervention type(s): Procedure; Procedure
Intervention description(s): video-assisted thoracic surgery approach
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: study the effect of a treatment and evaluate outcome postoperative
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: pulmonary hydatid cyst; video-assisted thoracic surgery; thoracotomy
Peginterferon Beta-1a (BIIB017) Autoinjector Pharmacokinetic Study in Healthy Volunteers
Condition: Healthy; Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the pharmacokinetic (PK) profile, safety, and
      tolerability of peginterferon beta-1a (BIIB017) delivered by the single-use autoinjector or
      prefilled syringe (PFS) in healthy volunteers to support the development of the autoinjector.
    

Detailed description: 
      This is a randomized, open-label, 2-sequence, 2-period crossover study that will be conducted
      at a single site in the United States to characterize the PK profile, safety and tolerability
      of peginterferon beta-1a delivered by autoinjector or PFS. Participants will be randomized in
      a 1:1 ratio to receive a single dose of peginterferon beta-1a at Day 1 delivered by either
      autoinjector or PFS, followed by a single dose of peginterferon beta 1a delivered by the
      other device at Day 22. The total duration of study participation is up to 3 months for each
      participant. Participants will complete a follow-up visit at Day 50 after the end of
      treatment period.
    

Intervention name(s): BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS); BIIB017 (peginterferon beta-1a) Autoinjector
Intervention type(s): Device; Device
Intervention description(s): 125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by PFS once on either Day 1 or Day 22; 125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by autoinjector once on either Day 1 or Day 22
Other intervention name(s): BIIB017; BIIB017
Intervention MeSH terms: Interferon-beta
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: SC; PEG; Inteferon; PK; Subcutaneous; PEGylated; Autoinjector; Injectable; MS