bioihbjkbjnl/mcl2 huggingface dataset:
Brain Activity Changes Following Neuroproprioceptive Physiotherapy in Multiple Sclerosis
Condition: Neuronal Plasticity; Multiple Sclerosis; Rehabilitation
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Imaging methods bring new possibilities for describing the brain plasticity processes that
      underly the improvement of clinical function after physiotherapy in people with multiple
      sclerosis (pwMS). The study determined whether facilitation physiotherapy could enhance brain
      plasticity, compared two facilitation methods, and looked for any relation to clinical
      improvement in pwMS.
    

Detailed description: 
      The study was designed as parallel group randomized comparison of two kinds of
      physiotherapeutic interventions referred to healthy controls.

      MS patients were examined by fMRI (primary outcomes) and clinical tests (secondary outcomes)
      at the beginning of study. Then, they were randomly divided into two groups (by drawing lots
      in a 1:1 ratio). The first group underwent Vojta reflex locomotion (VRL), and the second
      Motor Program Activating Physiotherapy (MPAT). The length and intensity of treatment was the
      same in both groups (two months, one hour twice a week). After the treatment, a clinical and
      fMRI examination was performed. Healthy volunteers underwent an fMRI examination that was
      considered to be a control.
    

Intervention name(s): Motor Program Activating Therapy; Vojta reflex locomotion
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients undergo ambulatory physiotherapy - Motor Program Activating Therapy (2 months, twice a week, 1 hour of duration). Therapy was undertaken at the ambulatory section of the Department of Neurology, Kralovske Vinohrady University Hospital in Prague.; Patients undergo ambulatory physiotherapy - Vojta Reflex Locomotion Therapy (2 months, twice a week, 1 hour of duration). Therapy was undertaken at the Department of Rehabilitation and Sport Medicine, Motol University Hospital.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study was designed as parallel group (outpatients) randomized comparison of two kinds of physiotherapeutic interventions referred to healthy controls.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Central Neck Dissection in Patients With Clinical Node Negative Thyroid Cancer
Condition: Stage I Papillary Thyroid Cancer; Stage II Papillary Thyroid Cancer; Stage III Papillary Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Cancer, Papillary; Thyroid Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial studies how well thyroid gland removal with or without central lymph node
      dissection works in treating patients with thyroid cancer or suspected thyroid cancer that
      has not spread to the lymph nodes (randomized into Arms I and II). Arms I and II are compared
      to a standard of care (SOC) Arm III to enable comparison of quality of life among various
      surgical treatments. Currently, the standard treatment for thyroid cancer is total
      thyroidectomy, or complete removal of the thyroid. The lymph nodes in the central part of the
      neck may also be surgically removed, called central lymph node dissection. Prophylactic
      removal of the lymph nodes may increase the risk of life-threatening complications, and may
      reduce post-surgery quality of life. It may also prevent the cancer from returning and reduce
      the need for additional surgery. It is not yet known whether recurrence rates and
      complication levels are lower after thyroid gland removal alone or with central lymph node
      dissection.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine the rate of transient and permanent hypocalcemia

      SECONDARY OBJECTIVES:

      I. To determine the rate of voice and swallowing problems.

      II. To determine the degree to which quality of life (QOL) is compromised.

      III. To determine the degree to which accurate quality of life measures can be extracted from
      patient interview narratives using natural language processing techniques.

      IV. To determine clinical recurrence rates.

      OUTLINE: Patients are randomized to 1 of 2 treatment arms, if ineligible into a SOC arm.

      Arm I: Patients undergo total thyroidectomy alone.

      Arm II: Patients undergo total thyroidectomy with ipsilateral prophylactic central neck
      dissection (CND).

      Arm III: Patients ineligible to be randomized into Arm I or II, Standard of Care (SOC)
      comparator receiving same follow up.

      After completion of study treatment, patients are followed up at day 1, 2 and 6 weeks, and 6
      and 12 months.
    

Intervention name(s): Thyroidectomy; entral lymph node dissection (CLND); Quality-of-life assessment
Intervention type(s): Procedure; Procedure; Other
Intervention description(s): Undergo total thyroidectomy; Undergo total thyroidectomy with ipsilateral prophylactic CND; Voice evaluation, interviews, ancillary studies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Strengthening in Functional Mobility of Active Elderly
Condition: Aged; Muscle Strength
Study type: Interventional

Summary: 
      Aging is characterized by functional losses among which, the related to mobility and balance
      may be highlighted. Regular physical activity, including muscle strengthening exercises, is
      beneficial to a healthy elderly. Thus, this study aimed to verify the influence of 8
      weeks-program of lower limbs strengthening exercises in the balance and functional mobility
      of physically active elderly. The investigators evaluated 18 women, with ages between 61 and
      80 years. Balance assessment was performed using the Functional Reach Test (FRT), Timed Up
      and Go (TUG) test and Romberg test in stable or unstable soil. For muscular strengthening of
      the lower limbs, the workload was determined by the strength reached in the eight-repetition
      maximum test (8RM), applying progressive load increments between training sessions conducted
      (50% , 60% , 70% of 8RM), with the muscle strength being reevaluated in the fourth week of
      training, with subsequent adjustment of the load for the subsequent training. The training
      took place in two weekly meetings, in 40-minute sessions, during eight weeks. Data were
      analyzed using the paired-t test and ANOVA with repeated measures. Among 18 evaluated elderly
      women, 7 completed the 8 week training proposed. Decrease in TUG time (p = 0,035) and
      statistically significant increase in muscle strength were observed in all muscle groups
      trained (quadriceps, hamstrings, adductors and abductors). FRT (p = 0.170) was not
      significantly different after training. Therefore, strength training proposed was efficient
      in improving muscle strength in the lower limbs of irregular physically active elderly,
      impacting positively on functional gain gait. However, the gain in muscle strength was not
      enough to generate significant results in static balance probably due to the type of exercise
      performed as well as due being limited to muscle groups of the lower limbs.
    


Intervention name(s): Muscle strength
Intervention type(s): Other
Intervention description(s): Strength training The strength training for lower limbs muscles occurred twice a week, 40 minutes per session for eight consecutive weeks.
n the first two weeks of training, each elderly performed the exercises with 50% of its load defined in 8RM test, increasing to 60 and 70% of the load in the third and fourth subsequent weeks, respectively. After this period, a new evaluation by 8RM strength test was conducted, adopting the fifth and sixth weeks of training 50% of value of the new load defined in 8RM test and to finalize the program in seventh and eighth weeks applied, respectively, 60% and 70% of the new charge. The exercises were performed for the quadriceps, hamstrings, muscles adductor and abductor hip.
Other intervention name(s): Resistance Training; Strength Training
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aged; Postural balance; Muscle strength
Celecoxib in Colposcopic Directed Biopsy
Condition: Colposcopy
Study type: Interventional
Phase: Phase 4

Summary: 
      Women often experience pain and discomfort during colposcopic examination especially at time
      of colposcopic directed excisional biopsy, pre-procedure anxiety, women pain threshold may
      also increase pain, woman's cooperation during the procedure is affected by all these
      factors, which also may hinder the colposcopist from obtaining adequate data and biopsies.

      Several pharmacological and non-pharmacological methods have been studied to reduce pain
      associated colposcopic directed biopsy (CDB). We aim to study the effect of Celecoxib to
      reduce pain associated with CDB.
    


Intervention name(s): Celecoxib 200mg; Colposcopic guided biopsy; Placebo oral capsule
Intervention type(s): Drug; Procedure; Drug
Intervention description(s): oral capsule 3 hours before procedure; Patient is placed in the lithotomy position. Vulva is examined for any suspicious lesions. A sterile bivalve speculum is introduced into the vagina to inspect cervix. A 3% acetic acid solution is applied to the cervix to map acetowhite areas for colposcopic directed punch biopsy using Tischler punch forceps.; oral capsule 3 hours before procedure
Other intervention name(s): celebrex 200
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: colposcopy - colposcopic directed biopsy - celecoxib
NeoCart Phase 2 Clinical Trial
Condition: Articular Cartilage Damage
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to gather additional information regarding the performance of
      NeoCart to fill articular cartilage defects in the knee.
    


Intervention name(s): NeoCart; microfracture
Intervention type(s): Biological; Procedure
Intervention description(s): autologous tissue implant; microfracture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 Administered Alone or With Dabigatran Etexilate
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to investigate the safety, tolerability and pharmacokinetics of BI
      655075 following intravenous administration of single rising doses of BI 655075 when
      administered alone and after administration of dabigatran.
    


Intervention name(s): Dabigatran; BI 655075; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Dabigatran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Comparison of IN 10 003 to Placebo in Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep
Condition: Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to assess the efficacy of IN 10 003 in improving sleep parameters in patients
      with Insomnia exhibiting both difficulty in falling asleep and staying asleep. The study will
      compare 2 formulations of the IN 10 003 to placebo
    


Intervention name(s): IN 10 003 formulation A; IN 10 003 formulation B; Placebo capsules
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of RO7062931in Healthy Volunteers and Subjects With Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized study will be conducted in two parts to evaluate the safety, tolerability,
      pharmacodynamics, and pharmacokinetics of subcutaneous administration of RO7062931. Part 1
      will include only healthy participants and Part 2 will include only participants with chronic
      hepatitis B (CHB). Part 1 is an adaptive, single-ascending dose study with an adaptive
      dose-escalating schedule to determine the best dose to be evaluated in participants with CHB.
      Part 2 is an adaptive, parallel multiple-dose study comprised of three sub-parts which will
      be used to further refine the dose and dosing regimen, and to evaluate the safety and
      efficacy of RO7062931 when administered with standard-of-care (SoC) therapy.
    


Intervention name(s): RO7062931; Placebo; Immune Modulator
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered subcutaneously in Parts 1 and 2. Part 1 will be administered in single-ascending doses after 0.1 mg/kg starting dose. Subsequent doses of 0.3, 1, 2 and 4 mg/kg may be administered based upon tolerability. In Part 2a, participants will receive two monthly doses of either 0.4, 0.8, 1.2 times the saturation dose or placebo. In Part 2b, a dose selected from Part 2a will be administered to participants randomized into 4 cohorts QW or Q2W. In Part 2c, participants will receive RO7062831 QW on top of another therapy for up to 24 or 48 weeks.; Part 1 cohorts: active drug vs placebo 4:1. Part 2a 4 parallel cohorts of 3 active drug doses and placebo in 1:1:1:1. Part 2b active drug vs placebo in 3:1 in 2 parallel cohorts.; Participants in Part 2c will receive an immune modulator subcutaneously QW for up to 48 weeks.
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Family Nurture Intervention, A Group Model in Connecticut
Condition: Behavior Problem; Development Delay; Emotional Disturbance; Family Conflict
MeSH terms: Problem Behavior; Affective Symptoms
Study type: Interventional

Summary: 
      The purpose of this current study is to investigate the efficacy of a group model of Family
      Nurture Intervention in ameliorating behavioral problems in preschool-aged children. The
      behavioral, neurobiological and clinical insights gained from this project may eventually
      lead to better treatment of emotional, behavioral and developmental disorders. The
      investigator hypothesizes that the children who are treated with Family Nurture Intervention
      (FNI), which incorporates interactive touch with vocal soothing, and family practice in
      comforting, will show increased emotional connection and mother child co-regulation with
      better results in the outcome measures in the short term and long term.
    

Detailed description: 
      There are several early intervention programs that are available for children with emotional,
      behavioral and developmental disorders, ranging from behavioral treatment and sensory
      exposure therapy to pharmaceutical treatments. Although improvements in behavior have
      resulted from these interventions, they are limited in numerous ways. They are usually
      time-consuming, both for the child and the teacher or clinician providing the intervention.
      In order to see an effect of the intervention, most children must engage in the intervention
      procedure for several years. Moreover, the effects of most current intervention procedures
      are minimal to moderate. Pharmaceutical prescriptions are often accompanied by undesirable
      side effects that may modulate behavior, emotion, and physiological functions. The
      behavioral, neurobiological and clinical insights gained from this project may eventually
      lead to better treatment of emotional, behavioral and developmental disorders.
    

Intervention name(s): Family Nurture Intervention; Nutrition and Play Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The mother-child pair will be asked to talk and play with each other as they customarily do. If the child becomes restless and dysregulated the mother will be coached by the Nurture Specialist to bring the child back into a calm state through sustained physical contact, comfort touch, soothing words, and eye contact.; Mothers and children in the Play and Nutrition group will play educational and nutrition-focused games.
Other intervention name(s): FNI; NPI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Family Nurture Intervention; Martha G. Welch MD; Randomized Control Trial; Pre-school Intervention; Preschool Intervention; Multiple Family Group Intervention; Emotional Connection; Co-regulation
A Study in Healthy Men to Test How Different Doses of BI 1595043 Are Tolerated
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this trial are to investigate safety, tolerability and
      pharmacokinetics (PK) of BI 1595043 in healthy male subjects following oral administration of
      single rising doses.
    


Intervention name(s): BI 1595043; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BI 1595043; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Reference Intervals for Sonoclot Analysis in Chinese
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      The reference intervals for Sonoclot Analysis may be different between Chinese and American.
      So far, no reference interval has been established in Chinese for Sonoclot Analysis. This
      study is going to establish the first Chinese reference intervals for Sonoclot Analysis and
      test whether they are different from American reference intervals.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Chinese healthy adults aged 18 and older
      
Biospecimen description: 
      2.7 mL citrated blood.
CT Dose Simulation Study for Appendicitis
Condition: Appendicitis
MeSH terms: Appendicitis
Study type: Observational

Summary: 
      The study will explore CT radiation dose as low as reasonably achievable in diagnosing acute
      appendicitis, by using of dose simulation technique and iterative reconstruction.
    

Detailed description: 
      Three sequential non-inferiority tests are planned. First, three readers will review the
      original 2-mSv images. Second, the readers will review the 75%-dose images. After the readers
      review the 75%-dose images and before the readers reviewed the 50%-dose images, the
      non-inferiority of 75% dose to the original dose will be tested. If the non-inferiority is
      not accepted, the study will be terminated with the conclusion of 2 mSv as the lowest
      acceptable dose. If the non-inferiority is accepted, the study will be continue to the next
      step. In the same manner, the readers will review the next lower-dose images (50% and then
      25%), and then the noninferiority will be tested against the original dose.
    

Intervention name(s): CT
Intervention type(s): Radiation
Intervention description(s): Contrast-enhanced CT images of the abdomen and pelvis will be obtained during the portal venous phase using a 256-channel CT system (Philips Healthcare, Cleveland, OH). The target median dose-length product (DLP) is 130 mGy·cm, which corresponded to an effective dose of 2 mSv with a conversion factor of 0.015 mSv·mGy-1·cm-1. The radiation output was automatically adjusted according to the individual patient's body size.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Emergency department visit with suspected symptoms and signs of acute appendicitis.
      
Keywords: Appendicitis; Tomography, X-Ray Computed; Receiver operating characteristic (ROC) Curve; Computer Simulation
Neuromodulation With Transcranial Direct Current Stimulation (tDCS) to Control Excess Weight
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the effects of noninvasive neuromodulation with
      transcranial direct current stimulation (tDCS) aimed at enhancing the excitability of the
      left prefrontal cortex in middle-aged women with excess body weight. This is a randomized,
      parallel, double-blind study with a duration of 4 weeks. Outcome measures will include
      changes in performance in a computerized task assessing executive functions, subjective
      measures of food craving and appetite and changes in body weight.
    

Detailed description: 
      A total of 40 subjects with overweight or class I obesity will be enrolled and randomized
      into either Group 1) Active tDCS or Group 2) Sham (control) tDCS. The duration of the study
      will be 4 weeks. During the first two weeks participants will receive eight sessions of tDCS.
      At week 2 they will also start a hypocaloric diet. The stimulation sessions (duration: 20
      minutes, intensity: 2 mA) will be applied once daily (5 days in a row) during the first week
      and 3 alternate days (Monday, Wednesday and Friday) during the second week. At week 2 and
      until the end of the study subjects will also start a hypocaloric diet.

      The study aims are:

        1. To examine whether anodal tDCS applied over the left prefrontal cortex can improve
           executive functions/inhibitory control and reduce subjective ratings of food craving and
           appetite.

        2. To study whether anodal tDCS applied over the left prefrontal cortex, in combination
           with a hypocaloric diet, can facilitate weight reduction and maintenance over time.
    

Intervention name(s): Transcranial Direct Current Stimulation (tDCS)
Intervention type(s): Device
Intervention description(s): Transcranial Direct Current Stimulation (tDCS) is a noninvasive form of neuromodulation that uses constant, low-intensity direct current delivered via electrodes that are placed on the head.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; overweight; neuromodulation; transcranial direct current stimulation (tDCS)