bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Physical Therapy on Axillary Web Syndrome After Breast Cancer Surgery
Condition: Axillary Web Syndrome
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      Objective: To determine the effectiveness of physical therapy on the axillary web syndrome in
      improving pain, reducing swelling and increasing mobility of the shoulder. Design: randomized
      single-blinded controlled trial. Follow-up: five physical therapy assessments:
      pre-intervention; post-intervention, 3 months post-intervention, 6 months post-intervention.
      Participants: Eighty consecutive women diagnosed with axillary web syndrome after undergoing
      unilateral breast cancer surgery with ALND or SLND at the Prıíncipe de Asturias Hospital in
      Alcalà de Henares, Madrid (Spain). Randomization: women will be randomly assigned to two
      groups by EpiData 3.1 software. Interventions: Physical Therapy group: Physical Therapy
      composed of manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific
      thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in
      conjunction with progressive active and action-assisted arm exercises; Control group:
      standard progressive active and action-assisted arm exercises. 9 physical therapy sessions.
    


Intervention name(s): Physical Therapy protocol; Control
Intervention type(s): Other; Other
Intervention description(s): Physical therapy protocol includes manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in conjunction with progressive active and action-assisted arm exercises "stretching" cords, and patient education.; Control protocol includes standard progressive active and action-assisted arm exercises & patient education.
Other intervention name(s): PT-AWS; CG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Axillary web syndrome; cording; physical therapy; breast cancer
Study of Safety and Efficacy of an Oral Contraceptive
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a non-comparative study. The primary objective of the study is to assess the efficacy
      of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are
      to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of
      the product.
    


Intervention name(s): Norethindrone acetate/ethinyl estradiol
Intervention type(s): Drug
Intervention description(s): one tablet per day
Intervention MeSH terms: Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Estradiol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Contraception
Testing a Brief Mindful Eating Program
Condition: Overeating; Overweight; Obesity
MeSH terms: Overweight; Hyperphagia
Study type: Interventional

Summary: 
      This project evaluated the effects of a brief manualized mindful eating intervention as a
      treatment for overeating with individuals with overweight and obesity.
    

Detailed description: 
      Overeating leads to overweight and obesity. Effective eating regulation largely depends on an
      individual's responsiveness to internal cues of physiological hunger and satiety; this
      phenomenon is known as interoceptive awareness and has been shown to be lower in individuals
      with overweight or obesity. Mindfulness training may improve interoceptive awareness and thus
      may facilitate more effective regulation of eating through increased sensitivity to cues of
      hunger and fullness. Mindful eating programs have been shown to increase interoceptive
      awareness of hunger and satiety cues and decrease weight in individuals with obesity.
      Although these programs are effective, they involve lengthy group sessions, require
      extensively trained staff, and are not widely available outside of clinical research. Thus,
      the reach and impact of these programs are limited.

      The present study developed and tested a brief mindful eating intervention inspired by
      Kristeller & Wolever's (2010) Mindfulness-Based Eating Awareness Training program to increase
      interoceptive awareness in individuals with overweight and obesity as a means to increase
      mindful and intuitive eating, reduce overeating and facilitate weight loss. The program
      consisted of 9 weekly 10-15 minute sessions structured around one simple evidence-based
      mindful eating exercise, and was delivered to adult (ages 18-67) employees from a Canadian
      university.
    

Intervention name(s): Brief mindful eating intervention
Intervention type(s): Other
Intervention description(s): Over the 9-week intervention, participants will be introduced to various mindful eating and intuitive eating practices which are aimed at reducing overeating and facilitating weight loss. Each session will focus on one simple, evidence-based message, aimed at modifying a current weight-relevant eating behavior of the patient. The intervention will focus on two key elements: (1) the mindful awareness of body cues (intuitive eating) and (2) the mindful awareness of external cues (mindful eating).
Intervention model: Single Group Assignment
Intervention model description: Pilot feasibility trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mindful eating; Overweight; Obesity; Intuitive eating; Overeating; Self-compassion
Crenobalneotherapy in the Treatment of Chronic Venous Insufficiency
Condition: Balneology
MeSH terms: Venous Insufficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      At 3 months, crenobalneotherapy session is superior to waiting list for patients with chronic
      venous insufficiency.
    


Intervention name(s): Crenobalneotherapy
Intervention type(s): Behavioral
Intervention description(s): 18 days of balneotherapy session in 3 weeks. Each day, the treatment associates 4 techniques: Kneipp Therapy, walking pool, underwater massage, bath tub and finishing with 20 minutes of rest in the Trendelendburg position. Kneipp Therapy is an alternating warm (28°C) and cold (14°C) shower on the legs during 10 minutes. Walking pool is a 60 cm deep pool at 23°C with underwater shower where patients are walking without stopping during 10 minutes. Underwater massage is realized by a senior physiotherapist. It starts at the feet and gradually rises to the thighs during 10 minutes. Bath tub is underwater shower at 30°C. It also starts at the feet and gradually rises to the thighs during 20 minutes. The interventions are standardized by timers. Adherence to each technique is supervised before each session in the usual manner for each patient treated in the spa center.
Other intervention name(s): Crenotherapy; Balneotherapy; Spa therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic venous insufficiency; Varicose vein; Crenobalneotherapy; Balneotherapy; Spa therapy
Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetic/Efficacy
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the safety and tolerability of multiple subcutaneous injections of various dosages
      of risperidone with clinically stable schizophrenia
    

Detailed description: 
      This will be an open-label, Phase 2A, multiple ascending dose study in 1 to 3 sites, designed
      to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of multiple
      subcutaneous injections of 60mg, 90mg, and 120mg doses of risperidone in the RBP-7000
      formulation, in subjects with clinically-stable schizophrenia who are on a once daily stable
      dose of 2mg, 3mg, or 4mg of oral risperidone.
    

Intervention name(s): Risperidone; RBP-7000
Intervention type(s): Drug; Drug
Intervention description(s): Oral risperidone was supplied as 2, 3, or 4 mg tablets in blister packs or bottles and taken daily only during the oral dosing periods of the study, days -14 through -8 (if applicable), days -7 through -1, and days 85 through 87.; RBP-7000 60 mg, 90 mg, and 120 mg were a mixture of the ATRIGEL® Delivery System and 60 mg, 90 mg, or 120 mg risperidone, respectively. Treatment was delivered as subcutaneous injections on study days 1, 29 and 57.
Other intervention name(s): Risperdal; risperidone in Atrigel
Intervention MeSH terms: Risperidone
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Schizophrenic; Schizophrenias
Safety and Immunogenicity Study of a Ross River Virus (RRV) Vaccine
Condition: Ross River Virus Disease (RRVD)
MeSH terms: Virus Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of this study is to assess the safety and tolerability of the Ross
      River Virus (RRV) Vaccine in a healthy young adult population. Other objectives of this study
      are to assess the immunogenicity of the RRV Vaccine in a healthy young adult population and
      to identify the optimal dose level of the RRV Vaccine in a healthy young adult population.
    


Intervention name(s): Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant
Intervention type(s): Biological
Intervention description(s): Two intramuscular injections of either 1.25 µg, 2.5 µg, 5 µg or 10 µg on Days 0 and 21, with a booster vaccination to follow 180 days after the first.
Intervention MeSH terms: Formaldehyde
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Open-Label Study of Oxycodone/APAP to Treat Post-Operative Pain Following Arthroscopic Knee Surgery
Condition: Disorder of Knee
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a pilot trial using this product in patients for the management of pain after
      outpatient arthroscopic knee surgery. This is an open-label study and the two active
      ingredients are well known pharmacologic entities.
    

Detailed description: 
      The objective of this single center is to evaluate the safety and efficacy of Oxycodone
      Extended Release (MNK-795) in postoperative pain following common musculoskeletal surgical
      procedures. Knee surgery being the most common surgery performed in the US, the investigators
      chose the model. The investigators also want to look at the flexible-dosing and titration
      which is the common way pain managed by clinicians. This is an open-label study of MNK 795 to
      be described in the procedures section.

      Primary endpoint:

      • Change in pain from baseline (before taking the first dose of study medication) measured on
      NRS

      Secondary endpoints:

        -  Patient/Investigator Global assessment of treatment satisfaction

        -  Safety evaluation with adverse event monitoring
    

Intervention name(s): Oxycodone
Intervention type(s): Drug
Intervention description(s): Oxycodone with Acetaminophen Extended Release
Other intervention name(s): Xartemix XR
Intervention MeSH terms: Oxycodone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Knee; Post-Operative Pain; Xartemis
Pain Intensity After Root Canal Instrumentation
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative; Pain
Study type: Interventional

Summary: 
      Assess the pain intensity in a two visit treatment of molars with irreversible pulpitis after
      instrumentation with two rotary systems Mpro and Hyflex files.
    


Intervention name(s): mechanical preparation of root canal system
Intervention type(s): Device
Intervention description(s): Assess the pain intensity in a two-visit treatment of molars with irreversible pulpitis after instrumentation with two different rotary Nickle Titanium systems
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Bioavailability Study of Metronidazole Capsules Under Fasting Conditions
Condition: To Determine the Bioequivalence Study Under Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the single-dose Bioavailability of Kali and G.D.
      Searle, Inc.
    

Detailed description: 
      To compare the relative Bioavailability of Metronidazole 375 mg Capsules with that of Flagyl
      375 mg Capsules in healthy, adult subjects under fasting conditions
    

Intervention name(s): Metronidazole; Flagyl
Intervention type(s): Drug; Drug
Intervention description(s): Capsules, single-dose, fasting; Capsules, single-dose, fasting
Other intervention name(s): Flagyl Capsules; Metronidazole Capsules
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence, single-dose, fasting
Pilot Indocyanine Green Imaging for Mapping of Arm Draining Lymphatics & Nodes in Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if Indocyanine Green (IC-GREEN) is comparable to
      isosulfan blue (IS-BLUE) in the identification of arm lymphatics and arm-draining nodes
      during nodal staging procedures in breast cancer.
    

Detailed description: 
      It is the objective of the current study to test Indocyanine Green (IC-GREEN) as an agent for
      mapping arm draining lymphatics and nodes and compare it to isosulfan blue (IS-BLUE) in the
      setting of sentinel node procedures with or without axillary node dissections in women with
      breast cancer. All participants will also have tumor samples evaluated with
      99technetium-sulfur colloid, a radiolabel used to identify tumor markers.
    

Intervention name(s): SPY Elite Imaging; Indocyanine Green; Isosulfan blue; 99technetium-sulfur colloid radiolabel
Intervention type(s): Device; Drug; Drug; Drug
Intervention description(s): A camera that is directed into the axillary cavity to try to capture an image of the tumor site labeled with Indocyanine green before and after excising sentinel nodes; started at 1mg /mL
If fluorescence is not detected with this dose, then it will be increased by 50%.; 3 to 5 mL
If fluorescence is not detected with this dose, then it will be increased by 50%.
Other intervention name(s): IC-GREEN; ICG; IS-BLUE; ISB; Lymphazurin; 99tech
Intervention MeSH terms: Technetium Tc 99m Sulfur Colloid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Epiretinal Macular Membrane and Cataract Extraction
Condition: Epiretinal Macular Membrane; Cataract Extraction
MeSH terms: Cataract
Study type: Interventional

Summary: 
      The investigators proposed to assess the functional and anatomical outcomes of cataract and
      idiopathic epiretinal macular membrane extraction in combined and consecutive surgeries.
    

Detailed description: 
      A retrospective nonrandomized clinical case series study collected 174 consecutive eyes of
      174 patients undergoing macular surgery between January 2005 and December 2006. Patients
      suffering from epiretinal macular membranes (ERM) secondary to uveitis, trauma, or associated
      with a simultaneous retinal detachment (RD) were excluded. We treated 109 eyes with a
      combined procedure (group 1) and 65 eyes with a consecutive surgery (membrane surgery and
      cataract separately)(group 2).
    

Intervention name(s): Consecutive surgery; Combined surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): Consecutive surgery for epiretinal macular membrane and cataract extraction; Combined surgery for epiretinal macular membrane and cataract extraction
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Focusing on the Maryam's Flower During the Birth
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      To determine the Effect of Focusing on the Virgin Mary Flower during the Birth Process on
      Labor Pain, Labor Duration and Perceived Fatigue in Birth.

      Method: The study will be completed in a randomized controlled manner with a total of 126
      primiparous pregnant women, 63 in the experimental group and 63 in the control group.
      Pregnant women in the experimental group will focus on the Virgin Mary flower in the
      water-filled jar and imagine that their uterus and birth path are opening like the branches
      of the Virgin Mary flower that blooms as labor pains come. There will be no intervention in
      the control group other than routine midwifery care. Research data will be collected with the
      Pregnant Introduction and Birth Process Follow-up Form, Visual Analog Scale, and Visual
      Similarity Scale for Fatigue.
    

Detailed description: 
      Design and Settings: This randomized controlled experimental study will conducted in the
      delivery room of the, Turkey between the dates of November 2023 and February 2024
    

Intervention name(s): Focusing on Maryam's Flower
Intervention type(s): Other
Intervention description(s): Effect of Focusing on Maryam's Flower During the First Phase of the labor
Other intervention name(s): Foccusing on Maryam's Flower
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
A Phase 1 Study of AV-380 in Healthy Subjects
Condition: Cachexia
MeSH terms: Cachexia
Study type: Interventional
Phase: Phase 1

Summary: 
      This double-blinded, placebo-controlled, single ascending dose (SAD) study is designed to
      evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity in
      healthy subjects of a single dose of AV-380. AV-380 is an immunoglobulin (Ig) G1 monoclonal
      antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15),
      a cytokine involved in cancer-induced cachexia.
    


Intervention name(s): AV-380; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia.; Placebo is sterile liquid for IV infusion.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
the Effect of coenzymeq10/Collagen Hydrogel on Bone Regeneration in Extraction Socket
Condition: Dental Implants
Study type: Interventional

Summary: 
      To investigate the effect of CoQ10 in soft tissue healing and bone regeneration after
      extraction in diabetic patients seeking dental implants. Methods: This study will be a
      randomized controlled clinical trial, 18 patients will be divided equally into three groups.
      In-vitro studies will be performed to investigate the release of CoQ10 from collagen,
      swelling ratio, and evaluation of gelation behavior. The patients will undergo tooth
      extraction and filling of the socket with either collagen or CoQ10/collagen. Empty sockets
      will serve as a negative control. The bone regeneration of the socket will be determined by
      radiography, histology, histomorphometry, and polymerase chain reaction (PCR) for bone
      markers.
    


Intervention name(s): Negative control group; Postive control; Study group
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): No intervention after extraction then delayed implant insertion at the site of extraction after three months; Application of collagen only in the socket after extraction then delayed implant insertion at the site of extraction after three months.; Application of acombination of CoQ10 and collagen hydrogel in the socket after extraction then delayed implant insertion at the site of extraction after three months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PSA Antibody Levels in Samples From Patients With Prostate Cancer Treated on Protocol ECOG-E9802
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the
      laboratory may help doctors identify and learn more about biomarkers related to cancer.

      PURPOSE: This clinical trial studies prostate-specific antigen (PSA) antibody levels in
      samples from patients treated for prostate cancer on trial ECOG-E9802.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To evaluate changes in prostate-specific antigen (PSA) antibody levels over time among
           patients treated on ECOG-E9802.

      Secondary

        -  To characterize the concordance of PSA antibody assessment between the ECOG Immunology
           Laboratory and the NCI Immunology Laboratory.

      OUTLINE: Previously tested samples are evaluated for changes in PSA antibody levels over time
      (from baseline to follow-up at 12 and 24 weeks) at the ECOG Immunology Laboratory and the NCI
      Immunology Laboratory. Results are compared between the laboratories.
    

Intervention name(s): laboratory biomarker analysis
Intervention type(s): Other
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples from patients who participated in E9802 and provided samples for research
      
Keywords: recurrent prostate cancer; stage I prostate cancer; stage IIA prostate cancer; stage IIB prostate cancer; stage III prostate cancer
A Study of Lebrikizumab in Participants With Uncontrolled Asthma on Inhaled Corticosteroids and a Second Controller Medication
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will
      evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease
      remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at
      least one second controller medication. Participants will be randomized in 1:1:1 ratio to
      receive double-blind treatment with either lebrikizumab ("high" or "low") or placebo,
      administered as subcutaneous (SC) injection every 4 weeks for 52 weeks, in addition to their
      standard-of-care therapy. This will be followed by a 52-week double-blind active treatment
      extension. Participants who were assigned to placebo during the placebo-controlled period of
      the trial will be re-randomized at Week 52 to receive blinded SC lebrikizumab 37.5 milligrams
      (mg) or 125 mg every 4 weeks from Weeks 53 to 104. The anticipated time on study treatment is
      104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.
    


Intervention name(s): Lebrikizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.; Lebrikizumab matching placebo will be administered as SC injection every 4 weeks for 52 weeks.
Other intervention name(s): RO5490255
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment