bioihbjkbjnl/mcl2 huggingface dataset:
OurRelationship.Com Effectiveness Study
Condition: Marital Conflict; Relationship, Marital
Study type: Interventional

Summary: 
      The purpose this study is to determine the continued reach and effectiveness of the
      OurRelationship.com program once paid advertising and payment for participation ceases. The
      answer to this question is essential to determining the sustainability of web-based
      interventions for couples. Specifically, this study has four aims:

        1. Examine continued level of initial interest in the study, as measured by number of
           initial visits to the website, time spent on the page, and number of couples signing up
           for the study.

        2. Measure any changes in the characteristics of the individuals expressing interest in the
           study, including demographics (e.g., race, ethnicity, education), relationship
           functioning (e.g., relationship satisfaction, previous help-seeking), and individual
           functioning (e.g., depression, anxiety)

        3. Determine completion rates and effectiveness of the program once payments for
           participation have been removed.

        4. Determine whether having a single Skype/phone call with a coach (rather than the four
           calls that were used in the NIH trial) significantly degrades completion rates.
    


Intervention name(s): OurRelationship Online Program
Intervention type(s): Behavioral
Intervention description(s): OurRelationship.com is an online program designed to improve distressed romantic relationships.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Couples are randomized to receive either one call with a coach or four calls with a coach.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OurRelationship; Couple therapy; Internet; Marriage Counseling
Weight Distribution Asymmetry in Relation to Speed During Gait in Children With Spastic Cerebral Palsy.
Condition: Gait, Spastic
MeSH terms: Muscle Spasticity; Cerebral Palsy; Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      Background: Improving walking ability is one of the major concerns in therapeutic
      interventions for children with cerebral palsy.

      Aim: determine the relation between the weight distributed on both lower limb and speed
      during walking.
    

Detailed description: 
      sixty children with spastic diplegia (group A) and forty-five with hemiparesis ( group B)
      with age ranged from ten to twelve, they had spasticity grade 1 and 1+ according to modified
      ashworth scale and they were able to walk with assistance (level II on Gross Motor
      Classification System).Evaluation was held by the Biodex gait trainer for measuring weight
      distribution on both lower limbs and speed during gait to determine if there was a relation
      between weight distribution asymmetry and the speed of gait of those children
    

Intervention name(s): assesment of gait
Intervention type(s): Other
Intervention description(s): speed and weight distribution during gait
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: assymetry-gait-speed-cerebral palsy
SGLT2 Inhibition: Uric Acid Excretion Study
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 4

Summary: 
      The current study investigates the effects of SGLT2 inhibitor empagliflozin on uric acid
      excretion.
    

Detailed description: 
      SGTL2 inhibitors improve cardiovascular and kidney outcomes. The underlying mechanisms are
      incompletely understood. SGLT2 inhibitors are known to reduce plasma uric acid likely by
      enhanced urinary uric acid excretion.

      In this study the investigators will study the effects of SGLT2 inhibit on uric acid levels
      and excretion in detail, linking it to the role of glucosuria and Uric acid transporter
      (URAT1) which in rodents was indispensable for the glucose-lowering effects of SGLT2
      inhibition.
    

Intervention name(s): Empagliflozin 25 MG; Benzbromaron; Empagliflozin 25 MG + benzbromarone 100 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 25 once daily one week treatment; 100 mg once daily 1 one week treatment; combined treatment once daily for one week
Intervention MeSH terms: Empagliflozin; Benzbromarone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 4-arm cross over, open label intervention study
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety Assessment of ZOlpidem (Stilnox CR) in Patients With Chronic insomNIA
Condition: Sleep Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To evaluate the efficacy and safety of the use of Stilnox CR in Mexican patients with chronic
      insomnia at the prescription conditions of daily practice

      Secondary Objective:

      To evaluate the satisfaction of the patient with chronic insomnia with Stilnox CR over an as
      needed basis.
    


Intervention name(s): ZOLPIDEM SL800750
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: Zopidem 12.5 mg tablets
Route of administration: Oral
Dose regimen:One tablet at bed time and as needed (the patients choose which night they take the tablet without limit of number of nights)
Intervention MeSH terms: Zolpidem
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
AXIS 2: AX200 for the Treatment of Ischemic Stroke
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy of AX200 (filgrastim) in the treatment of
      acute ischemic stroke and to assess the safety and tolerability of AX200.
    


Intervention name(s): Filgrastim; Sodium chloride solution
Intervention type(s): Biological; Drug
Intervention description(s): 135 μg/kg body weight total dose Short term infusion (20 to 30 minutes) and continuous infusion over 3 days; Short term infusion (20 to 30 minutes) and continuous infusion over 3 days
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of the Efficacy and Safety of the LEISH-F2 + MPL-SE Vaccine for Treatment of Cutaneous Leishmaniasis
Condition: Cutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy, safety, and immunogenicity of an
      investigational vaccine being developed for the treatment of leishmaniasis, including
      cutaneous leishmaniasis (CL). The vaccine, identified as LEISH-F2 + MPL-SE, consists of a
      Leishmania protein (LEISH-F2) together with an adjuvant MPL-SE.
    

Detailed description: 
      A phase 2, randomized, open-label, controlled study to evaluate the efficacy, safety, and
      immunogenicity of the vaccine administered three times (10 μg LEISH-F2 + 25 μg MPL-SE on Days
      0, 28 and 56) in the treatment of adults and adolescents with CL compared to treatment with
      standard chemotherapy (20 mg/kg/day sodium stibogluconate for 20 days). The proportion cured
      in each group will be determined using clinical criteria.
    

Intervention name(s): LEISH-F2 + MPL-SE; Sodium stibogluconate
Intervention type(s): Biological; Drug
Intervention description(s): 10 μg LEISH-F2 + 25 μg MPL-SE on Days 0, 28 and 56; 20 mg/kg/day IV daily for 20 days
Other intervention name(s): There are no other names for the vaccine.; Marfan SSG
Intervention MeSH terms: Antimony Sodium Gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Leishmaniasis; vaccine; immunotherapy
Observational Follow-up Study of REGATTA
Condition: Urinary Tract Infections
MeSH terms: Infections; Urinary Tract Infections
Study type: Observational

Summary: 
      Observational follow-up study of patients included in the clinical trial REGATTA.
    

Detailed description: 
      A follow-up telephone interview of the participants of the clinical trial REGATTA exploring
      the occurrence of urinary tract infections, pyelonephritis within a follow-up period of three
      months after inclusion.
    

Intervention name(s): Arctuvan; Placebo to Fosfomycin; Fosfomycin; Placebo to Arctuvan
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): application of a herbal drug in the clinical trial REGATTA (NCT03151603); application of Placebo to Fosfomycin in the clinical trial REGATTA (NCT03151603); application of an antibiotic drug in the clinical trial REGATTA (NCT03151603); application of Placebo to Arctuvan in the clinical trial REGATTA (NCT03151603)
Intervention MeSH terms: Fosfomycin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        participants of the clinical trial REGATTA
      
Keywords: herbal treatment; antibiotics; uncomplicated urinary tract infection
Elafibranor Pharmacokinetic Parameters in Renal Impaired Patients
Condition: Renal Impairment; Renal Insufficiency; Kidney Diseases; Pharmacokinetics
MeSH terms: Kidney Diseases; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted in order to assess the need for dose adjustment for elafibranor
      in participants with renal impairment. Pharmacokinetic parameters of elafibranor and its
      active metabolite (GFT1007) will be compared in severe renal impaired participants
      (eGFR<15mL/mn/1.73m^2) versus healthy participants after a single oral administration of
      elafibranor 120 mg
    


Intervention name(s): Elafibranor
Intervention type(s): Drug
Intervention description(s): 120mg oral single dose
Other intervention name(s): GFT505
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Q-Switched Nd:YAG in Macular Amyloidosis
Condition: Macular Amyloidosis
MeSH terms: Amyloidosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether Q-Switched Nd:YAG Laser therapy are
      effective in reduction of Cutaneous macular amyloidosis.
    

Detailed description: 
      We treat the macular amyloidosis cases by Q-Switched Nd:YAG Laser and compare the before and
      after treatment situation by the photos and colorimetric assessment.
    

Intervention name(s): Laser Therapy
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Dose-adjusted Adjuvant FEC Compared to Standard FEC for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open randomized phase III study. The primary objective of this study is to compare
      FEC adjuvant chemotherapy in operable breast cancer given either as fixed doses calculated
      according to the patients surface area or with doses adjusted according to leukopenia after
      course one in order to achieve hematological equitoxicity. The main aim of the study is to
      test whether chemotherapy dosage aimed at hematological equitoxicity will improve the effect
      of adjuvant chemotherapy.
    

Detailed description: 
      Group A, FECStandard(standard FEC) is given 7 courses of 5-fluorouracil-epirubicin
      (Farmorubicin)-cyclophosphamide with doses based on the patient's surface area. Leukocyte
      nadir values at day 10, 12 or 13 and 15 are measured. Dose-reductions of one step according
      to table 8.2.1 are performed in case of leukopenic fever or grade 4 leukopenia.

      Group B FECTailored(Tailored FEC) receives course one at identical doses to group A.
      Leukocyte nadir values at day 10,12 or 13 and 15 are measured. Doses of subsequent courses
      are adjusted to achieve grade 3 leukopenia (leukocyte nadir 1.0 to 2.0) in patients
      experiencing only grade 0 to 2 leukopenia after course one.

      Dose-reductions of one step according to table 8.2.1 are performed in case of leukopenic
      fever or grade 4 leukopenia .

      Patients achieving only grade 0-2 leukopenia at the first course will be randomized into
      continued treatment at standard doses (Group A) or to doses tailored to achieve grade 3
      leukopenia (Group B). The primary comparisons will be made between these two groups of
      patients.

      Patients with grade 3-4 leukopenia after the first course not be randomized but followed
      according to the protocol and received treatment as group A, FECStandard.
    

Intervention name(s): 5-FU, epirubicin and cyclophosphamide
Intervention type(s): Drug
Intervention description(s): Tailored dose escalation of epirubicin and cyclophosphamide.
Intervention MeSH terms: Cyclophosphamide; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer
Study of the Effects of a Mineralized Water Ingestion Upon Lipidic Absorption Mechanisms
Condition: Moderated Cholesterolemia
Study type: Interventional

Summary: 
      The principal objective of this research is the evaluation of the effect of mineralized water
      consumption upon evolution of LDL Cholesterol and triglycerides, compared to a low
      mineralized water consumption.
    


Intervention name(s): Mineralized water; Low mineralized water
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment
Condition: Parkinson Disease
MeSH terms: Parkinson Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety, tolerability, and potential effects on cognition of
      GRF6021, a plasma-derived product, administered as an intravenous (IV) infusion, to subjects
      with Parkinson's disease and cognitive impairment.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled study to assess the safety and
      tolerability of GRF6021, a plasma derived product, administered by intravenous (IV) infusion
      to subjects with Parkinson's disease (PD) and cognitive impairment. The study duration for
      the subjects will be approximately 7 months.
    

Intervention name(s): GRF6021; Placebo
Intervention type(s): Drug; Other
Intervention description(s): GRF6021 for IV infusion; Placebo for IV infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinson's Disease; Dementia
Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab
Condition: Breast Cancer; HER-2 Positive Breast Cancer; Effects of Chemotherapy
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy in terms of the pathological complete
      response (pCR) rate and the efficacy to preoperative administration of Anthracycline-based
      regimen followed by Nab-paclitaxel and Trastuzumab in patients with HER2 positive operable
      breast cancer.
    

Detailed description: 
      Four cycles of anthracycline-based regimen followed by four cycles of Nab-paclitaxel and
      Trastuzumab are administrated.

      Anthracycline-based regimen (d1, q3w):

      EC (Epirubicin 90mg/m2 and Cyclophosphamide 600mg/m2) AC (Doxorubicin 60mg/m2 and
      Cyclophosphamide 600mg/m2) FEC (Fluorouracil 500mg/m2, Epirubicin 100mg/m2 and
      Cyclophosphamide 500mg/m2)

      Nab-paclitaxel 260mg/m2 (d1, q3w)

      Trastuzumab (d1, q3w) is given at a dose of 8 mg/kg IV on day 1 of the first treatment cycle
      over 90 min, and subsequently given at a dose of 6 mg/kg over 30 min.
    

Intervention name(s): Nab-paclitaxel
Intervention type(s): Drug
Intervention description(s): Nab-paclitaxel 260mg/m2 q3w
Other intervention name(s): Abraxane
Intervention MeSH terms: Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Trastuzumab; Neoadjuvant chemotherapy; Primary chemotherapy
Young, Empowered & Strong (YES): The Young Women's Breast Cancer Study 2- Focus on Intervention Pilot
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This research study is piloting a new internet-based research tool (YES portal). The main
      purpose of this pilot study is to test the web-based interface.
    

Detailed description: 
      This study is being done to pilot a web-based research intervention tool. The investigators
      hope that by piloting it with the participants they can improve the tool and the other
      processes. The main purpose of this pilot study is to test the web-based interface, the
      participant's engagement with the platform, and the recruitment procedures. This initial
      pilot study will inform the design of a larger study intended to monitor common symptoms and
      behavior, and to provide supportive care information and research opportunities in an
      iterative manner for young women who have been diagnosed with breast cancer using the YES
      portal, built for smartphones, tablets, and computers.
    

Intervention name(s): YES portal
Intervention type(s): Other
Intervention description(s): The YES portal is designed to collect and assess participants' toxicities and symptoms, as well as informational needs in between visits with their clinician
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Breast Cancer
Percutaneous Endoscopic Gastrostomy Before Definitive Concurrent Chemoradiation Therapy for Esophageal Squamous Cell Carcinoma
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase II randomized study is to determine the efficacy of percutaneous endoscopic
      gastrostomy before definitive concurrent chemoradiotherapy (CCRT) in Patients with Esophageal
      Squamous Cell Carcinoma(ESCC) by assessing their weight, nutritional status, performance
      status and treatment response.
    

Detailed description: 
      This Phase II randomized study is to determine the efficacy of percutaneous endoscopic
      gastrostomy before definitive concurrent chemoradiotherapy (CCRT) in Patients with Esophageal
      Squamous Cell Carcinoma(ESCC) by assessing their weight, nutritional status, performance
      status and treatment response.

      All patients will receive definitive radiotherapy combined with three cycles of S-1 (40mg/2,
      BID, po) on D1-14, D22-35, D43-56. The primary endpoint is percentage of recent weight loss
      at the end of CCRT. The secondary endpoints are nutrition status, objective response rate,
      overall survival, toxicity and intestinal flora changes in blood, urine and stool specimens.
    

Intervention name(s): Concurrent chemoradiotherapy combined with enteral feeding by percutaneous endoscopic gastrostomy
Intervention type(s): Combination Product
Intervention description(s): One or two weeks before CCRT, all patients will undergo a percutaneous endoscopic gastrostomy (PEG) to be administered enteral nutrition support(30-35 kcal/kg of energy, 1.2-1.5g/kg of protein and electrolyte supplementation each day). Nutritional supplements will be administered till 1 month after CCRT.
All patients will receive definitive radiotherapy combined with three cycles of S-1 (40mg/2, BID, po) on D1-14, D22-35, D43-56.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: esophageal squamous cell carcinoma; percutaneous endoscopic gastrostomy; concurrent chemoradiotherapy; enteral nutrition support
Two Formulations of ELAPR Compared to Restylane® Vital Light Following Repeat Implants in the Upper Arm Dermis
Condition: Intrinsic Aging of Skin
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an early phase study comparing two fixed dose of the study compound ELAPR and a
      Restylane® Vital Light (control), by multiple intradermal injections to a 3cm x 3cm area of
      the upper arm dermis. All subjects will receive three treatments, 3 weeks apart. Each
      treatment will consist of 16 injections in total, each 10mm apart in a grid formation over a
      3cm x 3cm area of the mid - to deep dermis of the medial aspect of the upper arm. Each
      injection will consist of 20-30ul of product delivered using a 30Gx¼" needle.
    

Detailed description: 
      Each subject will also receive Restylane® Vital Light (control) to the opposite arm following
      the same treatment regimen and using the same technique. A 4mm skin biopsy will be taken from
      each of the implant sites from Cohort A subjects (including replacements) on Day 169, and
      from Cohort B subjects (including replacements) on Day 85. The biopsy will encompass the
      needle point tattoo at the centre of the implant site. The biopsy site will be closed with a
      single stitch followed by standard aftercare procedures with stitch removal 7 to 10 days
      later.
    

Intervention name(s): Tropoelastin
Intervention type(s): Device
Intervention description(s): Multiple intradermal implants comprising of three treatments, 3 weeks apart, each consisting of 16 injections in total, each 10mm apart in a grid formation over a 3cm x 3cm area of the mid to deep dermis of the medial aspect of the upper arm. Each injection will consist of 20-30ul of product delivered using a 30Gx¼" needle. Each subject will also receive Restylane® Vital Light (control) to the opposite arm following the same treatment regimen and using the same technique. The treatment will be administered on Day 1, 22 and 43.
Other intervention name(s): Restylane Vital Light
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Intrinsic Aging of Skin
Dry Needling Dosage in the Treatment of Myofascial Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The purpose of this study are (1) to determine the effectiveness of different dry needling
      dosages in the treatment of myofascial trigger points in the upper trapezius muscle in
      patients with myofascial neck pain, (2) to assess postneedling soreness and tenderness and
      (3) evaluate the influence of psychological factors on the perception of postneedling
      soreness.
    


Intervention name(s): Dry needling; Control
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment