bioihbjkbjnl/mcl2 huggingface dataset:
Does Inclusion of Diaphragmatic Breathing Exercises in Complete Decongestive Therapy Provide Further Benefits in Patients With Breast Cancer Related Lymphedema
Condition: Lymphedema, Breast Cancer; Lymphedema of Upper Limb
MeSH terms: Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
Study type: Interventional

Summary: 
      Complete decongestive therapy is proven to be effective in reducing lymphedema related
      symptoms such as swelling and pain. Breathing exercises, on the other hand, may also help
      managing lymphedema symptoms. Deep breathing creates a pressure change in the abdomen, which
      creates a vacuum effect in the thoracic cavity and helps to empty the lymphatic vessels.
      Thus, we aimed to investigate whether addition of diaphragmatic breathing exercises to
      physical exercise component of complete decongestive therapy provides further benefits on
      lymphedema volume, pain and quality of life in patients with breast cancer related
      lymphedema.
    


Intervention name(s): Complete Decongestive Therapy; Upper extremity exercises combined with diaphragmatic breathing exercises
Intervention type(s): Other; Other
Intervention description(s): Complete Decongestive Therapy will include manual lymphedema drainage (self) for 20 min everyday, skin care everyday, wearing compression garment or bandages everyday and upper-extremity exercises twice a day.; "Upper-extremity exercises" component of Complete Decongestive Therapy will be performed combined with diaphragmatic breathing exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study of Selpercatinib (LY3527723) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to determine how safe and how well tolerated selpercatinib
      is when given as oral doses to healthy participants. The study will also assess how fast
      selpercatinib gets into the blood stream and how long it takes the body to remove it. The
      study will last up to about 6 weeks, inclusive of screening period.
    


Intervention name(s): Selpercatinib
Intervention type(s): Drug
Intervention description(s): Administered orally.
Other intervention name(s): LY3527723; LOXO-292
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effects of Tolcapone on Decision Making and Alcohol Intake in Alcohol Users
Condition: Alcohol Abuse; Impulsive Behavior
MeSH terms: Alcoholism; Impulsive Behavior; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effects of tolcapone on decision making and
      alcohol intake using a laboratory bar (on-site alcohol self-administration) in alcohol
      drinkers.
    

Detailed description: 
      The study is a 7-session, double blind, placebo-controlled crossover study of the effects of
      tolcapone, the COMT inhibitor, on decision making and alcohol intake using a laboratory bar
      in moderate to heavy social alcohol drinkers. Subjects will be moderate to heavy social users
      of alcohol, defined as at least 10 standard drinks per week for women and at least 14
      standard drinks per week for men. There will be one screening session followed by six
      additional visits including 2 laboratory bar sessions. On each study drug administration day,
      subjects will come in to the clinic for a medication dispensation visit and instructions on
      when and how to take the study drug for the remainder of the study. Study drug bottles will
      be equipped with MEMS caps to ensure compliance. After 5 days of drug administration,
      subjects will return to the clinic for a laboratory bar. This session will consist of
      administration of a standardized laboratory bar paradigm and a series of computerized and
      written decision-making tasks. Subjects will then be crossed over and complete the same
      series of study visits on the alternate study drug.
    

Intervention name(s): Tolcapone; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Tasmar
Intervention MeSH terms: Tolcapone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Efficacy of Axial Stability on Improving Gait and Balance Performance in Children With Dyskinetic Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The aim of this study will be to evaluate the effect of TheraTogs orthotic undergarment and
      strapping system on increasing axial stability that will reflect on improving balance and
      walking performance in children with dyskinetic cerebral palsy.
    

Detailed description: 
      The aim of this study will be to evaluate the effect of TheraTogs orthotic undergarment and
      strapping system on increasing axial stability that will reflect on improving balance and
      walking performance in children with dyskinetic cerebral palsy. Forty children with
      dyskinetic CP will be assigned randomly into two groups (A & B). Control group (A) will
      receive conventional rehabilitation program for postural correction 2 hours/3 sessions
      weekly/3 successive months. Study group (B) will receive conventional rehabilitation program
      as in group (A) in addition to wearing Thera Togs soft orthotic undergarment. Patients
      evaluation will be carried out before and after the intervention programs to assess gait and
      balance performance using Noraxons myo pressure plate and Biodex balance system.
    

Intervention name(s): TheraTogs Arm; Traditional Treatment
Intervention type(s): Other; Other
Intervention description(s): TheraTogs Arm Received Soft Orthotic undergarments; Traditional treatment to Dyskinetic CP
1- Trunk control exercises 2- Core stability training 3- Proximal dynamic stability for the shoulder and pelvic girdles components. 4- Back and abdominal strengthening exercises 5- Standing exercises : - Standing alone gradually increase time. - Stride standing alone. - Step standing alone (other limb supported on wooden step then soft step and finally on small ball). - Standing on balance board
Other intervention name(s): Experimental
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Lurasidone Effects on Tissue Glutamate in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      24 individuals with schizophrenia or schizoaffective disorders, who are currently considered
      stable, will be recruited, screened for entry criteria into a blinded study with a 4-week
      randomization to either lurasidone, haloperidol, or perphenazine to examine glutamate-related
      outcomes with lurasidone as compared to haloperidol and perphenazine.
    

Detailed description: 
      At study start all volunteers will be discontinued from their current antipsychotic drug
      (APD) and switched to haloperidol 4mg for 5 days. At the end of this discontinuation period,
      all baseline symptom ratings and cognition testing will be done, as well as the baseline
      imaging procedures. At the end of the baseline procedures, volunteers will be blindly
      randomized, either to lurasidone at 40mg (N=12), or to haloperidol at 4mg/d or perphenazine
      at 16mg/d (N=12). Doses will increase to 80mg/d lurasidone, 8 mg/d haloperidol, or 32 mg/d of
      perphenazine at the beginning of week two. Dose should be stable for the last 3 weeks of
      treatment unless side effects are prominent, then the dose can be decreased to 40
      lurasidone/4 haloperidol/16 perphenazine mg/d for optimal clinical management. The
      randomization strategy will be designed and implemented by the research pharmacist in four
      blocks of six volunteers; drug will be dispensed by the research pharmacy according to the
      randomization schedule. The randomization will be followed by a four week treatment period at
      optimal dose levels. On the last two days of the 4 week stable dosing period, the specified
      glutamate outcome measures will be completed (neuroimaging and cognitive testing) along with
      all the symptom outcome measures, testing for drug plasma levels, and usual blood safety
      measures. Patients will be seen weekly for clinical evaluation; suicidality will be monitored
      weekly. All medications other than study drugs will be discontinued, as much as possible, for
      the 24-48 hr assessment period. After the evaluation phase, patients will be cross-titrated
      back to their original treatment medication and dosing.

      This design will generate outcomes from 12 patients on lurasidone vs. 12 patients on
      haloperidol/ perphenazine.
    

Intervention name(s): Lurasidone; Haloperidol; Perphenazine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Compare to haloperidol and perphenazine; Compare to lurasidone; Compare to lurasidone
Other intervention name(s): Latuda; Haldol; Trilafon
Intervention MeSH terms: Haloperidol; Haloperidol decanoate; Lurasidone Hydrochloride; Perphenazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; schizoaffective; cognition; lurasidone; Latuda
Effects of Smoking on Non-surgical Periodontal Therapy in Generalized Aggressive Periodontitis
Condition: Generalized Aggressive Periodontitis; Smoking
MeSH terms: Periodontitis; Aggressive Periodontitis; Aggression
Study type: Interventional

Summary: 
      Smoking is the major preventable risk factor in the initiation and progression of periodontal
      diseases. Periodontitis risk was found to be 3.9 times higher among smokers aged between
      19-30 years and 2.8 times higher among smokers aged 31-40 years compared to non-smokers.
      Aggressive periodontitis (AgP), is characterized by a rapid attachment loss usually
      incompatible with the amount of plaque and dental calculus. It is often not possible to
      predict the prognosis of treatment with various treatment options in cases of aggressive
      periodontitis. It was hypothesized that non-smoker patients with generalized aggressive
      periodontitis (GAgP) will respond better to conventional mechanical non-surgical periodontal
      therapy compared to the smokers. Therefore, the aim of this study was to evaluate the effects
      of smoking on the outcomes of non-surgical periodontal treatment in terms of the clinical,
      biochemical and microbiological parameters.
    


Intervention name(s): Non-surgical periodontal therapy
Intervention type(s): Procedure
Intervention description(s): Patients were motivated and instructed to brush with modified Bass technique and use interdental toothbrushes, dental floss. Each patient underwent quadrant scaling and root planning (SRP) under local anaesthesia over a 4-week period. Root planing (RP) was performed under local anaesthesia (2% lidocaine, epinephrine 1:100.000) and a standard curette set newly sharpened with Arkansas stone was used for each patient.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Generalized aggressive periodontitis; Non-surgical periodontal therapy; Periodontopathogens; Smoking; Gingival crevicular fluid
Clinical and Histological Evaluation of BTL-785F Non-invasive Treatment for Facial Rejuvenation
Condition: Wrinkle
Study type: Interventional

Summary: 
      This study will evaluate the clinical efficacy, safety and the performance of the BTL-785-2
      applicator of the BTL-785F system for non-invasive treatment of facial wrinkles and
      correcting facial skin laxity.
    

Detailed description: 
      The changes in the skin tissue related to the levels of hyaluronic acid (HA) will be assessed
      histologically. The study is a prospective, single-center, three-arm, open-label study. The
      subjects will be enrolled and assigned into two treatment groups; group A (RF & USN) and B
      (only RF) which will receive a treatment with different settings. Subjects of both groups
      will be required to complete four (4) treatment visits and two follow-up visits.
      Additionally, a Control will be included to verify the treatment outcomes.

      At the baseline visit, health status will be assessed. Inclusion and exclusion criteria will
      be verified and informed consent will be signed. Punch biopsies of the facial skin for the
      examination of changes related to HA levels and photographs of the treated area will be
      taken.

      The treatment administration phase in both treatment groups will consist of four (4)
      treatment visits, delivered 7 - 14 days apart.
    

Intervention name(s): BTL-785-2; No Treatment
Intervention type(s): Device; Other
Intervention description(s): Treatment with BTL-785 device (BTL-785-2 applicator) for non-invasive facial rejuvenation; The subject who will serve as control will not be treated with the study device.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Safety, PK, and Preliminary Effects on Scar Formation of Multiple Intradermal Administrations of RXI-109
Condition: Cicatrix; Scar Prevention
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to evaluate the safety and tolerability of multiple (3)
      intradermal doses of RXI-109 at small surgical incisions in the abdominal skin of healthy
      volunteers. The effect of RXI-109 versus placebo on scarring at these incision sites will be
      evaluated visually, histologically, and by biomarker analysis.
    


Intervention name(s): RXI-109; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Multiple intradermal injections of RXI-109 at incision sites; Multiple intradermal injections of placebo at incision sites
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Scar; Scar prevention; Fibrosis
Study to Evaluate the Safety and Efficacy of Filgotinib and Lanraplenib in Adults With Lupus Membranous Nephropathy (LMN)
Condition: Lupus Membranous Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, Membranous
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the efficacy of filgotinib and lanraplenib
      (previously GS-9876) in adults with lupus membranous nephropathy (LMN).
    


Intervention name(s): Filgotinib; Lanraplenib; Filgotinib placebo; Lanraplenib placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 200 mg tablet administered orally once daily; 30 mg tablet administered orally once daily; Tablet administered orally once daily; Tablet administered orally once daily
Other intervention name(s): GS-6034; GLPG0634; GS-9876
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Colorectal Cancer Screening for Cancer Survivors
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      The risk of colorectal cancer (CRC) is significant among cancer survivors treated with
      abdominal radiation therapy (RT). Further, CRC is once of the few cancers for which there is
      effective screening. Although some expert groups recommend early CRC screening for patients
      with prior abdominal RT, the effectiveness of early screening is unknown. It is also unknown
      if radiation-induced CRC passes through a "pre-clinical" phase in which precancerous polyps
      are detectable and treatable prior to becoming invasive cancers. This study will evaluate
      whether screening will detect pre-invasive colorectal polyps among survivors treated with RT.
    

Detailed description: 
      Cancer survivors meeting the COG criteria for CRC screening will undergo colonoscopy and
      removal of colorectal polyps. Documentation of polyp number, location and pathologic
      characteristics will be made. Clinical data information will also be collected at the time of
      patient enrollment.
    

Intervention name(s): Colonoscopic examination
Intervention type(s): Other
Intervention description(s): All patients enrolled in the study will undergo a colonoscopic examination and complete a baseline questionnaire.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who have received radiation treatment to the abdomen,pelvis or spine.
      
Keywords: Colorectal cancer screening; Cancer survivor; Radiation therapy
Safety of 40K Pegylated Recombinant Factor IX in Non-Bleeding Patients With Haemophilia B
Condition: Congenital Bleeding Disorder; Haemophilia B
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe, Japan and the United States of America (USA).

      The aim of this clinical trial is to investigate the safety and pharmacokinetics (the
      determination of the concentration of the administered medication in blood over time) of
      Pegylated Recombinant Factor IX (nonacog beta pegol) in Non-Bleeding Patients with
      Haemophilia B.
    


Intervention name(s): nonacog beta pegol; nonacog beta pegol; nonacog beta pegol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Cohort to receive a single dose of 25U/kg nonacog beta pegol administered intravenously (into the vein); Cohort to receive a single dose of 50U/kg nonacog beta pegol administered intravenously (into the vein); Cohort to receive a single dose of 100U/kg nonacog beta pegol administered intravenously (into the vein)
Other intervention name(s): 40K PEG-rFIX; 40K PEG-rFIX; 40K PEG-rFIX
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
E7080 Food Effect Study in Healthy Subjects
Condition: Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a randomized, single-dose, open-label, two-period crossover study in 16 healthy
      subjects. The study will consist of two phases: Pre-randomization and Randomization. The
      Pre-randomization phase will have two periods: Screening and Baseline. In the Randomization
      Phase, subjects will be randomized to one of two possible treatment sequences (fed/fasted and
      fasted/fed). In each period, subjects will receive a single capsule containing 10 mg
      lenvatinib either with or without a standard breakfast. There will be a 2-week washout
      between treatments.
    


Intervention name(s): HOPE; HOPE
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg lenvatinib (1x10 mg lenvatinib capsule) with food; 10 mg lenvatinib (1x10 mg lenvatinib capsule) without food
Other intervention name(s): E7080; E7080
Intervention MeSH terms: Lenvatinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Effectiveness of Orthopedic Spinal Supports in the Treatment of Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether orthopedic spinal supports are effective in
      the treatment of low back pain.
    

Detailed description: 
      Back pain is a common and expensive medical condition. Although rarely life-threatening, back
      disorders are a major cause of pain, disability, and social cost affecting the quality of
      life in most patients. Although primary care providers routinely treat back pain, little is
      known about how often primary care providers manage occupation-related symptoms and how
      outcomes compare with other treatment modalities. Treatment outcomes utilizing a
      non-operative treatment paradigm have not been adequately studied. This paradigm consists of
      treating patients sequentially with analgesics, physical therapy, use of back supports,
      caudal epidural steroid injections, or surgical referral. The use of spinal supports as a
      complimentary treatment along with physical therapy and posture education is promising.
    

Intervention name(s): Back supports
Intervention type(s): Device
Intervention description(s): The spinal / back supports are made of polymer shield covered by fabric and foam to be used externally to relieve back pain and offer spinal support. They are to be placed in the chair used in workstation related jobs.
Other intervention name(s): Moller Back Support System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: backache; low backpain; sciatica
Maternal Uterine Artery Doppler Study
Condition: Maternal-Fetal Exchange
Study type: Observational

Summary: 
      The purpose of this study is to detect if adding resistance to maternal blood flow from the
      arm will help increase the blood flow through the uterine arteries to the placenta and the
      baby.
    

Detailed description: 
      In the setting of uteroplacental insufficiency, there is little that can be done to increase
      blood flow through the uterus and placenta. Historically, women with growth restricted
      fetuses or oligohydramnios have been placed on bed rest. Unfortunately, this treatment
      modality has met with only limited success. Cardiologists have long recognized the simple act
      of making a fist or otherwise occluding blood flow through a limb dramatically increases a
      person's peripheral vascular resistance. If maternal peripheral resistance can be increased,
      perhaps the increased differential between the maternal peripheral vascular resistance and
      that of the uteroplacental unit will increase flow through the uterus and placenta.
    

Intervention name(s): Any patient eligible for an Ultrasound greater than or equal to 18 weeks gestation without a fetal or uterine anomaly.
Intervention type(s): Other
Intervention description(s): bilateral Uterine artery Doppler readings pre- and during blood pressure measurement
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women greater than or equal to 18 weeks gestation and 18 years old eligible for an
        ultrasound without fetal or uterine anomalies
      
Keywords: Pregnant women; Uterine Artery Doppler Velocimetry