bioihbjkbjnl/mcl2 huggingface dataset:
Sophrology and Congenital Heart Disease
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      The SOPHRO-CARE trial aims to measure the impact of sophrology on exercise capacity of
      adolescents and young adults with congenital heart disease.

      Investigator hypothesized that a series of group sessions of sophrology may improve the
      exercise capacity, in this population.
    

Detailed description: 
      Adolescents and adults with congenital heart disease (CHD) have reduced exercise capacity
      compared to the general population.

      Our recent randomized trial in a population of children and adolescents with asthma showed
      that sophrology improve lung function (NCT02114398). Sophrology, from the Greek "study of
      consciousness in harmony", is an adjuvant therapy, considered in healthcare as a relaxation
      technique, mainly based on breathing.

      Investigator assume that adolescents and young adults (13-25 y.o.) with CHD who participate
      in a program of sophrology with structured group sessions will improve their exercise
      capacity as measured by the maximum oxygen uptake (VO2max), in comparison with a control
      group.
    

Intervention name(s): Sophrology sessions; usual care
Intervention type(s): Other; Other
Intervention description(s): 8 sophrology sessions, approximately 60 minutes each, spread over 12 months; usual care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Ultrasound Guided Rhomboid Intercostal and Subserratus Plane Block in Breast Cancer Surgeries
Condition: Breast Cancer Surgery; Postoperative Analgesia
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Postoperative analgesia after breast cancer surgery is a challenge for anesthesiologists due
      to the complex innervation of the breast. Interfascial plane blocks of the chest are gaining
      widespread popularity with the introduction of ultrasonography into the regional anesthesia
      practice. We aimed to investigate the efficacy of Rhomboid intercostal and subserratus plane
      block (RISS) for postoperative analgesia in patients undergoing breast cancer surgery.
    

Detailed description: 
      This prospective randomized controlled trial will be carried out on female patients who
      scheduled for breast cancer surgery. Our hypotesis is that this new interfascial plane block
      technique will able to provide postoperative analgesia in breast cancer surgery.
    

Intervention name(s): Rhomboid Intercostal and Subserratus Plane Block with local anesthetic
Intervention type(s): Drug
Intervention description(s): Local anesthetic will be injected in the tissue planes between the rhomboid and the intercostal muscles and the serratus anterior and external intercostal muscles with ultrasound guidence.
Other intervention name(s): 40 mL of bupivacaine/lidocaine mixture
Intervention MeSH terms: Lidocaine; Bupivacaine; Anesthetics, Local; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective study
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rhomboid intercostal and subserratus plane block
A Trial of Two Diets for Weight and Diabetes Management
Condition: Type 2 Diabetes Mellitus; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a low-fat or low-glycemic load diet is more
      effective for controlling weight and blood glucose in persons with type 2 diabetes.
    

Detailed description: 
      This research is a randomized controlled trial to compare long-term outcomes behavioral
      weight loss interventions that include either low-fat or low-glycemic load dietary
      instruction. Targets for energy intake and expenditure, and behavioral skills taught, are
      identical across the two diets. Additionally, both treatments include 20 weekly group
      sessions, followed by 10 every-other-week sessions. Participants are overweight and obese
      adults with type 2 diabetes. The primary outcomes are changes in weight and glycated
      hemoglobin. Those randomized to the low-glycemic load diet are expected to achieve greater
      weight losses and maintain better glycemic control at the end of treatment (i.e., week 40)
      and after 1 year of no-treatment follow-up (i.e., week 92).
    

Intervention name(s): Lifestyle Modification
Intervention type(s): Behavioral
Intervention description(s): Weekly group therapy for 20 weeks, followed by bi-weekly group therapy for 20 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Type 2 Diabetes; Glycemic Load; Weight Loss; Glycated Hemoglobin
A Phase 2a, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine the safety, pharmacokinetics and efficacy of orally
      administered VX-135 with ribavirin in treatment naive subjects with chronic hepatitis C
      infection.
    

Detailed description: 
      Up to twenty (20) subjects with CHC GT1 infection will be randomized in a 1:1 ratio (with
      stratification by IL-28B genotype (CC versus non-CC)) to evaluate VX-135 low dose or high
      dose both given in combination with RBV for 12 weeks.

      Safety and tolerability will be evaluated on an ongoing basis through assessment of adverse
      events (AEs), lab evaluations and physical examinations. Subjects will be monitored from Day
      1 through end of follow-up for virologic breakthrough or relapse.
    

Intervention name(s): VX-135; Ribavirin
Intervention type(s): Drug; Drug
Intervention description(s): 12 weeks of VX-135; 12 weeks of ribavirin
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
CD19 /22 CAR T Cells (AUTO3) for the Treatment of B Cell Acute Lymphoblastic Leukemia (ALL)
Condition: B Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Lymphoblastic Leukemia; Refractory Childhood Acute Lymphoblastic Leukemia; B-cell Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to test the safety and efficacy of AUTO3, a CAR T cell treatment
      targeting CD19 and CD22 in paediatric or young adult patients with relapsed or refractory B
      cell acute lymphoblastic leukaemia.
    

Detailed description: 
      The study will consist of 2 phases, a Phase I or dose escalation phase and a Phase II or
      expansion phase. Paediatric or young adult patients with relapsed or refractory B cell ALL
      will be enrolled in both phases of the study. Eligible patients will undergo leukapheresis in
      order to harvest T cells, which is the starting material for the manufacture of the
      autologous CAR T product AUTO3 which is a CD19 and CD22 dual targeting CAR T cell product.
      Following pre-conditioning by a chemotherapeutic regimen, the patient will receive AUTO3
      intravenously as a single or split dose and will then enter a 24-month follow-up period.
    

Intervention name(s): AUTO3 (CD19/22 CAR T cells
Intervention type(s): Biological
Intervention description(s): Following preconditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with 1 to 5.0 x 10⁶/kg CD19/CD22 Chimeric Antigen Receptor (CAR) positive T cells as a single or split dose.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Lymphoblastic Leukaemia; CD19 Positive; CD22 Positive; Relapsed Acute Lymphoblastic Leukaemia; Refractory Acute Lymphoblastic Leukaemia; AUTO3
24-hour Efficacy and Ocular Surface With Talfuprost and Triple Combined Therapy
Condition: Glaucoma; Ocular Surface Disease
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 4

Summary: 
      The study investigated the 24-hour efficacy and ocular surface health with preservative-free
      tafluprost and a combined preservative-free regimen (tafluprost and dorzolamide/timolol fixed
      combination) in open-angle glaucoma patients insufficiently controlled on latanoprost
      monotherapy and showing signs, or symptoms of ocular surface disease with
      preservative-containing latanoprost monotherapy. This trial randomized open-angle glaucoma
      patients insufficiently controlled (IOP > 20 mm Hg) on branded, or generic latanoprost
      monotherapy who required further IOP reduction and who demonstrated clinical signs, or
      symptoms of ocular surface disease.
    


Intervention name(s): tafluprost; tafluprost and dorzolamide/timolol
Intervention type(s): Drug; Drug
Other intervention name(s): Saflutan, Taflotan; Saflutan, Taflotan, Cosopt PF
Intervention MeSH terms: Timolol; Dorzolamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: tafluprost; dorzolamide; timolol; FC
Randomized Trial of Tapas Acupressure for Weight Loss Maintenance
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This randomized clinical trial evaluates the efficacy of TAT(Tapas Acupressure Technique)
      compared to a Social Support (SS) group for the primary outcome of weight loss maintenance.
      We recruit obese adults from the Kaiser Permanente Northwest managed care setting. Those who
      meet eligibility criteria are entered into an intensive six-month weekly group-based
      behavioral weight loss program. Those who meet threshold weight loss criteria (n=~288) are
      randomly assigned to either TAT instruction or social support group. Participants in both
      groups attend the same schedule of group meetings with parallel contact hours. Participants
      in the TAT group are advised to practice the technique at home. Participants are weighed and
      questionnaires administered at entry, randomization, and at 12 and 18 months post entry. The
      main outcome measure is weight at 18 months.
    


Intervention name(s): Tapas Acupressure Technique; Social support
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Practice of the TAT technique involves application of pressure to select acupoints combined with specific mental focus. The TAT pose involves lightly touching the tips of the left thumb and 4th finger to the area 1/8 inch above the inner corner of each eye and the 3rd finger to the point midway between the eyes, about ½ inch above eyebrow level. The right hand is on the back of the head, with the palm cradling the occiput and the thumb just above the hairline. Once in this position, the process is to 1) focus attention on the identified problem or behavior to be changed (e.g., over-eating); 2) focus on a positive thought related to the problem; 3) focus on the thought of healing or clearing the origins of the problem; and 4) focus on an awareness of healing or clearing any storage of the problem, at a cellular, mental, emotional, or energetic level.; The LIFE SS maintenance intervention will consist of a series of professionally facilitated social support groups where the session content is directed by the participants. The contact hours for SS will match those of the TAT intervention. The initial SS group session will orient participants to the basics of weight maintenance, and subsequent sessions will provide opportunities for participants to share experiences and ask questions. Participants may choose to use behavioral tools as desired. In addition to the basic materials about weight loss maintenance used in both maintenance interventions, will we use the materials already used in the weight loss program for the SS group as needed. We will measure adherence by taking attendance at the SS group sessions.
Other intervention name(s): TAT; Social support groups
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Expression of NIS Protein and mRNA in Thyroid Tumors
Condition: Tumors
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Study type: Observational

Summary: 
      The uptake of iodide by thyroid cells requires the expression of sodium iodide symporter
      (NIS). Thyroid benign and malignant tumors have low iodide uptake activity. Previous studies
      of NIS expression with RT-PCR and immunohistochemistry showed divergent data. NIS protein was
      overexpressed in thyroid cancer. The aim of this study was to investigate the NIS transcript
      levels and its presence and localization in 30 samples of thyroid tumors (14 benign and 16
      malignant) and in their surrounding non-tumoral tissues (NT), by real time RT-PCR and
      immunohistochemistry, respectively. Our results revealed lower gene expression in 78.6% of
      the benign tumors and 100% of the carcinomas when compared with the NT samples, using GHPDH
      as a housekeeping gene. Immunohistochemical staining revealed presence of NIS protein in 100%
      of the non-tumoral samples, 100% of the benign tumors and 93.75% of the malignant tumors. NIS
      protein was identified at basolateral membrane in 23.3% of non-tumoral samples, 14.3% of
      benign and 12.5% of malignant tumors. Stronger cytoplasmatic immunostaining of NIS protein
      was detected in 64.3% of benign tumors and in 87.5% of malignant tumors when compared to NT.
      Association between low gene expression and strong cytoplasmatic immunostaining was found in
      50% of benign tumors and 87.5% of malignant tumors. We concluded that the reduced NIS gene
      expression in thyroid tumors associated with strong intracytoplasmatic staining may be due to
      its incapacity to migrate to cellular membrane.
    

Detailed description: 
      The aim of this study was to quantify NIS transcript levels by real time PCR and to determine
      the presence and cellular localization of NIS protein by immunohistochemistry, in benign and
      malignant thyroid tumor cells and to compare with their paired surrounding non-tumoral cell.
      NIS expression was also compared to that of the TSHR
    

Time perspective: Other
Keywords: NIS; thyroid adenoma; thyroid cancer; Iodine uptake; expression
Effectiveness and Safety of Acupuncture for Climacteric Syndrome in Patients With Breast Cancer
Condition: Climacteric Syndrome
MeSH terms: Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the investigators study is to create the evidence of effectivness on
      climacteric syndrome in patients affected by breast cancer, by acupuncture added to the
      standard care (self care).
    

Detailed description: 
      The study will be performed under randomized, open, controlled design. The effect of
      acupuncture and control group will be compared including the following outcomes: Greene
      climacteric scale score, quality of life (MenQol italian version), overall improvement in
      climacteric syndrome, adverse effects from treatment.
    

Intervention name(s): acupuncture; self care
Intervention type(s): Device; Other
Intervention description(s): 10 sessions of acupuncture; physical exercice, diet, self help groups, psychological support
Other intervention name(s): chinese traditional medicine; self help
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: climacteric, climacteric syndrome
Altering Toenail Biomechanic in Managing Ingrown Toenail.
Condition: Ingrown Toenail
MeSH terms: Nails, Ingrown
Study type: Interventional

Summary: 
      Ingrown toenail is commonly met in clinical practice.treatment may be non-operative and
      operative treatment.operative trestment depends on lateral wedge resection of the nail. The
      idea is to change toenail biomechanics by central toenail resection.
    

Detailed description: 
      The aim of this study is to compare between central toenail resection with ordinary lateral
      wedge resection in managing ingrown toenail. This study was performed on 100 patients divided
      into 2 groupd each is 50 patients. Group A underwent central resection while group B
      underwent lateral toenail resection.
    

Intervention name(s): Central toenail resection; Wedge toenail resection
Intervention type(s): Procedure; Procedure
Intervention description(s): Using local aneasthesia, resection of central part of toenail with germinal matrix.; Using local anaesthesia,we remove lateral part of toenail .
Other intervention name(s): Surgical resection; Surgical resection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Ingrown toenail; Biomechanic; Central resection; Recurrence
Effect of CPAP on Blood Pressure in Patients With Sleep Apnea and Refractory Hypertension
Condition: Obstructive Sleep Apnea; Refractory Arterial Hypertension
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of CPAP treatment on blood pressure in
      patients with sleep apnea syndrome (SAS) and refractory arterial hypertension (RAH).

      Also, some of the mechanisms mediating SAS and RAH (systemic inflammation, oxidative stress,
      sympathetic hyperactivity) will be analyzed.
    


Intervention name(s): CPAP; Control
Intervention type(s): Device; Device
Intervention description(s): continuous positive airways pressure; Patients are 3 months without any change in their treatment, and are in the waiting list to come into the CPAP procedure after that time
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obstructive sleep apnea; refractory arterial hypertension; continuous positive airways pressure
Effect of Breathing Exercise During Peripheral Intravenous Catheter
Condition: Venipuncture
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      This study was carried out to determine the effect of breathing exercise performed during
      peripheral intravenous catheter (PIVC) application on pain, anxiety and patient satisfaction.

      The study was completed as a randomized controlled experimental study with a total of 130
      individuals who met the inclusion criteria. The Descriptive Characteristics Questionnaire,
      the State-Trait Anxiety Inventory, and the Numerical Rating Scale were used to collect the
      data of the study. In addition, Algometer (66 Lb/30 Kg) device was used to evaluate the pain
      pressure threshold in determining the individuals to be included in the research sample. The
      individuals in the intervention group were given diaphragmatic breathing exercise while
      applying the catheter, and the individuals in the control group were inserted without any
      application.
    

Detailed description: 
      This study was carried out to determine the effect of breathing exercise performed during
      peripheral intravenous catheter (PIVC) application on pain, anxiety and patient satisfaction.

      The study was completed as a randomized controlled experimental study with a total of 130
      individuals who met the inclusion criteria, 65 of whom were in the intervention group and 65
      in the control group. Ethics committee approval, institutional permission, and written
      informed consent from individuals were obtained in the study. The Descriptive Characteristics
      Questionnaire, the State-Trait Anxiety Inventory, and the Numerical Rating Scale were used to
      collect the data of the study. In addition, Algometer (66 Lb/30 Kg) device was used to
      evaluate the pain pressure threshold in determining the individuals to be included in the
      research sample. The individuals in the intervention group were given diaphragmatic breathing
      exercise while applying the catheter, and the individuals in the control group were inserted
      without any application.
    

Intervention name(s): Breathing exercise
Intervention type(s): Other
Intervention description(s): Diaphragmatic breathing exercises were taught to the individuals by the researcher and they were asked to start breathing exercises before starting PIVC. While the PIVC was being placed, the individuals continued the breathing exercise and the breathing exercise was terminated at the end of the application.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Anxiety; Breathing exercise; Nursing; Pain; peripheral intravenous catheterization
Endometrial Biopsy Instrument Comparison Study
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine the level of pain women experience during an
      endometrial biopsy and the effect that the biopsy tool might have on that pain. The
      investigators will also evaluate the adequacy of the sample each endometrial biopsy tool
      collects.
    

Detailed description: 
      Is there a difference in pain perceived by patients undergoing endometrial biopsy via the
      Pipelle or Explora curette? Currently, the instrument selected for endometrial biopsy is
      solely dependent on provider preference. This study aims to elucidate advantages and/or
      disadvantages of the Pipelle versus the Explora curette in terms of pain perceived by the
      patient, adequacy of sample, and provider ease of use to better aid in the selection of the
      appropriate device.
    

Intervention name(s): Pipelle de Cornier; Explora curette
Intervention type(s): Device; Device
Intervention description(s): A flexible suction cannula 23.5 cm in length with an inner diameter of 2.6 mm and an outer diameter of 3.1 mm. It has a 2.4mm diameter opening on the distal end, on one side of the cannula. It is a disposable polypropylene sheath with an inner plunger and is used for blind endometrial biopsy.; The curette has an outer diameter of 3.0 mm and is slightly more rigid. This cannula has a sharp Randall-type cutting edge on the distal end, on one side of the cannula.
Other intervention name(s): Pipelle; Explora
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: endometrial biopsy; pain management