bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Subantimicrobial Dose Doxycycline for Moderate to Severe and Active Graves' Orbitopathy
Condition: Graves Ophthalmopathy; Graves Disease; Eye Diseases; Thyroid Diseases; Endocrine System Diseases; Eye Diseases, Hereditary; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases
MeSH terms: Eye Diseases; Graves Disease; Graves Ophthalmopathy; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is to evaluate the effects of subantimicrobial dose doxycycline (50
      mg/d), administered for 12 wk, for patients with active moderate-severe Graves' Orbitopathy
      (GO).
    

Detailed description: 
      Graves'orbitopathy is an autoimmune disease characterised by an inflammatory phase followed
      by fibrosis. Surgery to correct eyelid swelling, proptosis, and diplopia is effective, but
      can not be done until the inflammatory phase has passed. To arrest the inflammatory phase,
      several types of immunosuppressive treatments have been investigated. Corticosteroids are the
      first-choice immunosuppressive treatment, but they often cause severe side-effects.

      Subantimicrobial dose doxycycline posses known anti-inflammatory effects that are separate
      from their antibacterial mode of action. This mode of action has lead to the routine use of
      subantimicrobial dose doxycycline for rosacea, periodontitis and multiple sclerosis.

      We propose to test the effect of subantimicrobial dose doxycycline for non-sight threatening,
      moderate-severe, inflammatory GO.
    

Intervention name(s): Doxycycline
Intervention type(s): Drug
Intervention description(s): Tab. Doxycycline 50 mg PO per day for 12 weeks
Other intervention name(s): Dolotard; Tibirox; Biomycin
Intervention MeSH terms: Doxycycline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Graves' orbitopathy; Graves´ ophthalmopathy; Thyroid eye disease; Thyroid-associated ophthalmopathy; Doxycycline; EUGOGO; CAS
Recurrent Low Back Pain: Linking Mechanism to Outcomes (RCT)
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this randomized clinical trial of low back pain exercise programs is to
      determine if trunk control can be changed by core stabilization exercises. The proposed
      mechanism of pain reduction and functional improvement of core stabilization exercises is
      that it enhances trunk movement and muscle control. This study will provide preliminary
      evidence of the link between patient outcomes and treatment mechanisms.

      The investigators hypothesize that:

        -  both treatment groups will demonstrate significant improvements in pain and function;

        -  only subjects in the core stabilization group will demonstrate significant improvements
           in trunk movement and muscle control.
    


Intervention name(s): Core Stabilization; Trunk Motion and Fitness
Intervention type(s): Other; Other
Intervention description(s): 3 Stages: Stage 1: emphasis on neutral spine position, co-contraction of stabilizing muscles with performance feedback through observation and palpation for correct muscle activation; patient education
Stage 2: promotes maintenance of co-contraction while performing movements of the arms/legs and trunk progressing to preformance of these exercises on unstable surfaces; trunk muscle conditioning also emphasized; feedback gradually reduced.
Stage 3: emphasis on maintenance of co-contraction while performing functional activities; stable and unstable surfaces; use of perturbation and random practice to enhance motor learning.; 3 Stages: Stage 1: reducing pain and restoring spine motion and flexibility; patient education
Stage 2: trunk muscle conditioning exercises
Stage 3: trunk muscle conditioning and cardiovascular conditioning exercises
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: low back pain; core stabilization; trunk muscle exercises; physical therapy; RCT
Tractography and Diffusion Tensor Imaging of the Human Spinal Cord in Healthy Subjects : Anatomical Atlas
Condition: Healthy Volunteer
Study type: Interventional

Summary: 
      Today, Spinal cord pathologies, whether are tumoral, vascular, traumatic, malformative,
      inflammatory, or degenerative still constitute a major medico-surgical challenge due to the
      particular anatomy of the spinal cord. Indeed, the spinal fibers (whether they have a sensory
      or motor function) are all condensed in an extremely small volume. To date, there is no
      reliable technique to know the precise position of the spinal tracts specifically involved in
      the sensory and motor functions of the upper and lower limbs.

      The purpose of this study is to evaluate the feasibility for differentiating spinal tracts by
      tractography from a cerebral Diffusion tensor imaging (DTI) Magnetic Resonance Imaging (MRI)
      sequence (associated with an anatomical sequence) by performing a stitching process with
      spinal cord DTI MRI sequence, in healthy subjects. The criterion of differentiation of the
      tracts will be assessed by highlighting already known cerebral tracts (cortico-spinal fibers,
      spinothalamic, posterior cord) and which will be monitored at the spinal level.
    


Intervention name(s): Spinal cord Tractography in order to differentiate spinal tracts.
Intervention type(s): Procedure
Intervention description(s): Spinal cord tractography using DTI MRI sequences of the brain and spinal cord, in order to differentiate tracts at the spinal cord level; and by performing a stitching process between Brain and Spinal cord DTI sequences.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Tractography, DTI, MRI, spinal cord
The Effect of Radiofrequency-treatment on Patients With Facet-joint Pain in Cervical- and Lumbar-columna
Condition: Neck Pain; Low Back Pain
MeSH terms: Arthralgia; Low Back Pain; Neck Pain
Study type: Interventional

Summary: 
      There is conflicting evidence on whether radio-frequency neurotomy of the medial branch has a
      significant effect on pain in patients with chronic unilateral facet joint neck and back
      pain.

      We will evaluate radiofrequency treatment on medial-branch of the ramus dorsalis as an
      effective pain treatment for patients with chronic pain originated from facet-joints in
      cervical and lumbar columna.
    


Intervention name(s): radiofrequency treatment; sham neurotomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Radiofrequency-neurotomy of the medial branch at 80 degr. C needle temperature for 70 seconds, after diagnostic blocks; Radiofrequency-neurotomy of the medial branch at 37 degr. C needle temperature for 70 seconds, after diagnostic blocks
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: radiofrequency
Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the long-term safety and tolerability of rapastinel as an adjunctive
      to antidepressant therapy (ADT) in patients with major depressive disorder (MDD).
    


Intervention name(s): Rapastinel
Intervention type(s): Drug
Intervention description(s): Rapastinel pre-filled syringes for IV injections.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Barriers to Effective Weight Loss in Overweight Adolescents
Condition: Overweight
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      The current study aims to investigate the impact of a comprehensive, team-based,
      family-centered, lifestyle modification program on body weight, metabolic abnormalities,
      fitness measures, and self-esteem in overweight adolescents beginning the study at ages 11-18
      years. The intensive program will uniquely include a "team" structure and a component
      designed to address the role of parental modeling in effective lifestyle changes. By
      comparing the demographic, psychosocial, and metabolic characteristics of adolescents
      according to the degree of weight loss, the study will also more fully characterize the
      barriers that prevent successful participation in an intensive lifestyle modification
      program.
    

Detailed description: 
      The study will annually enroll 100 - 200 adolescent male and female subjects between 11 and
      18 years of age with a BMI > the 85th percentile and one parent. Adolescents enrolled in the
      study, will participate in a structured exercise program and meet regularly with a dietitian
      and behavior specialist for nutrition education and review and update of progress and goals.
      The study is designed for 2 years of participation with data collection points at baseline, 3
      months, 6 months, 1 year and 2 years. Data collected from adolescents include demographic
      information anthropometric information (height, weight, blood pressure, temperature, pulse,
      percent body fat); assessments of nutritional knowledge, food choices and dietary intake;
      assessments of activity and fitness level of behavioral status (depression, self-esteem,
      self-confidence, satisfaction with life, happiness, perspectives on health, exercise and
      diet, family environment, quality of life, body awareness, teasing, social efficacy,
      self-perception, coping mechanisms), assessments of sleep time and quality and physiological
      and medical data (including blood and urine tests)

      Parents will accompany their children to the nutrition and behavior support visits, and
      attend 12 group educational sessions to learn skills and strategies to help their children
      adopt healthier eating and exercise behaviors. Data collected from parents will include
      demographic, anthropometric measures (height, weight, blood pressure, temperature, pulse,
      percent body fat); and assessments of activity level, dietary intake and eating habits,
      behavioral status, child-feeding practices, and understanding of their child.
    

Intervention name(s): Lifestyle modification
Intervention type(s): Behavioral
Intervention description(s): Dietary modification and regular physical activity
Other intervention name(s): Weight Loss; Wellness
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: overweight; obesity; adolescent; insulin resistance; treatment
Phase III of Gemcitabine Vs TS-1 Vs Gemcitabine Plus TS-1 in Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      In patients with unresectable advanced pancreatic cancer, non-inferiority of TS-1 monotherapy
      and superiority of GEM + TS-1 combination therapy to gemcitabine (GEM) will be verified using
      survival time.
    


Intervention name(s): Gemcitabine plus TS-1; TS-1; Gemcitabine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Gemcitabine plus TS-1:Gemcitabine was administered i.v. by 1000 mg/m2 at day 1, 8 followed by 2 week rest as 1 course. TS-1 was co-administered orally at 40 mg/m2 twice daily for 14 days with a rest period of 1 week as one course.; TS-1 was administered orally at 40 mg/m2 twice daily for 28 days with a rest period of 2week as one course.; Gemcitabine was administered i.v. by 1000 mg/m2 at day 1, 8, 15 followed by 2 week rest as 1 course.
Intervention MeSH terms: Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreatic Cancer
A Study to Evaluate Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects With Albuminuria
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Albuminuria
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate pharmacodynamics, safety, tolerability and
      pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects with Albuminuria
    


Intervention name(s): MT-3995 Low; MT-3995 High; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): MT-3995 Low dose for 8 weeks; MT-3995 High dose for 8 weeks; Placebo for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetic Nephropathy
Comparison of Suturing and Packing of Drained Abscesses
Condition: Cutanoeus Abscesses
MeSH terms: Abscess
Study type: Interventional
Phase: Phase 2

Summary: 
      The standard treatment for skin abscesses in drainage followed by packing to prevent
      premature closure and reaccumulation of pus. Studies from the 1950s and later conducted
      outside of the US suggest that when drained abscesses are drained and sutured closed they
      actually heal faster without complications. The current study compares the time to healing
      and scar formation when drained abscesses are packed or sutured.
    


Intervention name(s): PRIMARY CLOSRE; SECONDARY CLOSURE; SPONTANEOUS HALING
Intervention type(s): Other; Other; Other
Intervention description(s): SUTURE; ALLOW TO HEAL SPONTANEOUSLY; SECONDARY HEALING AFTER I&D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: abscess, primary closure, secondary closure
Effectiveness of Passive and Active ROM Exercises Following TKA
Condition: Osteoarthritis; Total Knee Arthroplasty
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of the study is to determine the effectiveness of new interventional approaches
      in the early postoperative phase following total knee arthroplasty (TKA). It is assumed that
      active training programs are more effective in improving physical function than the passive
      standard-of-care therapy.
    

Detailed description: 
      The major objectives of rehabilitation after TKA are the early regain of range of motion
      (ROM) and mobilization of the patient. Continuous passive motion (CPM) is frequently used as
      part of the postoperative care regime following TKA with the aim to increase knee joint
      mobility and improve postoperative recovery despite little conclusive scientific evidence.
      Conflicting research findings have generated an ongoing debate on its usage. As the greatest
      loss of function occurs in the first month following TKA, it is surprising that the ROM
      therapy during hospital stay is still carried out passively. A passive mobilization of the
      knee joint with CPM does not encourage the patients to actively participate in their
      rehabilitation. Research on the effectiveness of active ROM exercises added to standard
      physiotherapy during the short in-hospital period is lacking so far.The objective of this
      study is to compare the passive clinical standard therapy (CPM) with different active
      training programs (controlled active motion, CAM). It was hypothesised that the CAM therapies
      are more effective in improving physical function than the CPM therapy.
    

Intervention name(s): continuous passive motion (CPM); controlled active motion (CAM I); controlled active motion (CAM II)
Intervention type(s): Other; Other; Other
Intervention description(s): standard-of-care therapy (control intervention); Patients receive three 30 minutes CPM applications (unilateral op-leg) each day from the second postoperative day until 1 day prior to discharge.; Patients receive three 30 minutes CAM applications (unilateral op-leg) each day from the second postoperative day until 1 day prior to discharge.; Patients receive three 30 minutes CAM applications (bilateral alternating) each day from the second postoperative day until 1 day prior to discharge.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rehabilitation; total knee arthroplasty; range of motion; continuous passive motion; controlled active motion; postoperative physical therapy
Efficacy and Safety of Poly-L-lactic Acid
Condition: Flaccidity, Muscle
MeSH terms: Muscle Hypotonia
Study type: Interventional

Summary: 
      This study aims to assess efficacy and safety of Sculptra in the treatment of skin flaccidity
      in selected areas - arms, anteromedial region, and gluteal regions. To assess the efficacy of
      Sculptra®, via adapted Global Aesthetic Improvement Scale -GAIS- score determined by blind
      evaluator, in the treatment of skin flaccidity on the anteromedial region of arm and gluteal
      region, 4 months after initiating the treatment, based on the assessment of the corporal side
      randomized to be the first to receive treatment . Considering as an alternative hypothesis of
      interest a 70% value of the subjects the treated side would have higher GAIS than the
      untreated side.
    

Detailed description: 
      Ethical and General considerations regarding the study conduction: This study protocol will
      be reviewed and approved by appropriate IEC/IRB prior to the initiation of the study.

      Clinical monitoring: Study conduction will be closely monitored by Galderma representatives,
      following GCP regulations, applicable standard operating procedures, guides and local
      regulations.

      Data Management: Data may be audited by Galderma Quality Assurance Department and/or CRO
      prior to or after results of the first statistical analysis on the primary discretion.

      Quality assurance, auditing and Inspection: The study will be carried out under the
      sponsorship of Galderma in accordance with all local and federal regulations, as well as ICH
      guidelines. Audits and inspections at the research site may be conducted by Galderma
      representatives or local authorities. All aspects in any study step can be audited by
      Galderma Quality Assurance / CRO and, as a result, a certificate stating this will be
      provided.
    

Intervention name(s): Poly-L-lactic acid - Sculptra
Intervention type(s): Device
Intervention description(s): Participants using Sculptra - Poly-L-lactic acid 3 sessions in the first side and 3 sessions on the second side
Intervention model: Single Group Assignment
Intervention model description: The study sample will be stratified to include 50% of subjects, who will receive Sculptra treatment on the antero-medial side of the arms and approximately 50% of subjects, who will receive Sculptra treatment in the gluteal area, in order to exploratory analyzes by subgroup.
During the study, the subjects should come to the research site up to nine times: one for the screening/inclusion visit (SV), three treatment visits (TVs) for Side 1 (from 1 to 14 days after SV, and from 1 to 2 months after first session), three TVs for Side 2 (4, 5 and 6 months after the first S1 treatment session), one follow-up visit (FUV), 6 months after the first S2 treatment session) and a final visit (FV) (12 months after the first S1 session). After 4 months of the first treatment we will compare the results between the first treated side and non-treated side.
Masking: None (Open Label)
Primary purpose: Treatment
Predicting Cognitive Resilience Against Sleep Loss
Condition: Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      Resilience is the ability to cope effectively and adapt to a wide range of stressful
      environmental challenges. Sleep loss has been shown to reduce activity in the brain regions
      responsible for resilience. The ability to resist the effects of sleep loss appears to be a
      stable, trait-like quality. This study will attempt to predict individuals' trait-resistance
      to sleep loss based on their neurobiology.
    

Detailed description: 
      Resilience, the ability to cope effectively and adapt to a wide range of stressful
      environmental challenges, appears to be mediated extensively by the medial prefrontal cortex
      (MPFC). Sleep deprivation has been shown to reduce metabolic activity throughout the brain,
      particularly the MPFC. The ability to resist the effects of sleep loss appears to be a
      stable, trait-like phenomenon that is consistent across situations, suggesting that it may
      reflect an enduring quality of the underlying neurobiological system. The present study aims
      to identify the neural basis of resilience and effectively discriminate resistant from
      vulnerable individuals during an overnight sleep deprivation session. Specifically, the
      primary aims of this research are 1) to further our understanding of the role of the MPFC in
      resilience and 2) to develop a statistical prediction algorithm based on multimodal
      neuroimaging that will reliably discriminate between individuals who are resilient versus
      vulnerable to the cognitive impairing effects of sleep loss.
    

Intervention name(s): Sleep deprivation
Intervention type(s): Behavioral
Intervention description(s): Participants will undergo 29 hours of sleep deprivation. They will wake up at 7:00 am on the day of the study and remain awake in the laboratory until 12:00 pm the next day.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Sleep Deprivation