bioihbjkbjnl/mcl2 huggingface dataset:
Analysis of Pain and Quality of Life in Patients With Charcot-Marie-Tooth Neuropathy (CMT)
Condition: CMT
MeSH terms: Charcot-Marie-Tooth Disease; Nerve Compression Syndromes; Hereditary Sensory and Motor Neuropathy
Study type: Observational

Summary: 
      The study aims to qualitatively and quantitively evaluate pain in patients suffering from CMT
      with 3 standardized questionnaires (SF-36, NPSI-G, PAIN DETECT) as well as its impact on the
      quality of life.
    

Detailed description: 
      Hereditary neuropathies are a group of clinically and genetically heterogeneous diseases of
      the peripheral nervous system. Charcot-Marie-Tooth disease (CMT), also known as hereditary
      motor and sensory neuropathy (HMSN), is the most common form of hereditary neuropathy with a
      prevalence of approximately 1 in 2,500 and with approximately 30,000 affected persons in
      Germany. There is no therapy known so far. In addition to the characteristic symptoms of a
      distal to proximal progressive symmetric muscular atrophy, especially of the lower
      extremities, there is a weakening of the muscles of the lower legs and feet, with emphasis on
      the "small" foot muscles and the peroneal muscle group, which clinically manifests as a
      so-called "stepper gait". It is also known that many CMT patients additionally suffer from
      pain, but more detailed studies on pain quality and quantity and their impact on patients'
      quality of life have not yet been systematically performed. These parameters will be
      investigated in this study, supported by the company Grünenthal, in the form of a
      questionnaire survey with validated questionnaires on pain and quality of life for at least
      200 CMT patients. A representative result could lead to further investigations of pain in CMT
      patients and ultimately to the development of an adequate pain therapy.

      Recruitment of patients will occur mainly through a call of the Germany-wide CMT registry,
      which is part of the national research network CMT-NET (coordinator: Prof. Michael Sereda).
      Interested patients are invited to contact the study team at the UMG. The patients will be
      informed about the study and if further interested 4 questionnaires (1 regarding the personal
      history as well as 3 standardized questionnaires from literature regarding quality of life
      and pain (SF-36, NPSI-G, PAIN DETECT) will be sent to the patients together with obligatory
      study documents and a pre-franked return envelope. A personal visit at the UMG is not
      planned, so that the patients don´t have any expenses. The data are pseudonymized at the UMG
      and transferred to a database and finally statistically evaluated by Gruenenthal.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        German-wide, registered patients in CMT-registry
Ideal Anatomic Location for Saphenous Nerve Blocks: A Prospective Clinical Evaluation
Condition: Foot Injury; Ankle Injury
MeSH terms: Wounds and Injuries; Ankle Injuries; Foot Injuries
Study type: Interventional

Summary: 
      This research is being done to compare two different saphenous nerve block locations and will
      help to determine which site best maintains knee strength and pain control.
    

Detailed description: 
      This is a prospective, randomized, observer blinded clinical trial comparing motor strength
      in knee extension between two sets of patients, one receiving a proximal thigh block of the
      saphenous nerve and one receiving a distal thigh block of the saphenous nerve. The secondary
      objectives are to compare the pain relief and quality of life of participants in these two
      groups.
    

Intervention name(s): Saphenous Nerve Block
Intervention type(s): Procedure
Intervention description(s): A nerve block will be performed by the anesthesiologist. The location of the nerve block will be per randomization envelope (proximal vs. distal) and performed just prior to foot or ankle surgical procedures that require a saphenous nerve block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adult; nerve blocks in foot and ankle surgery; saphenous
Reflux in Spinal Cord Injury Patients With Neurogenic Lower Urinary Tract Dysfunction
Condition: Vesico-ureteral Reflux; Spinal Cord Injury
MeSH terms: Gastroesophageal Reflux; Spinal Cord Injuries; Vesico-Ureteral Reflux; Wounds and Injuries
Study type: Observational

Summary: 
      The purpose of this study is to investigate the incidence of reflux in patients with spinal
      cord injury in relation to the lesion level, duration of injury and bladder management
    

Detailed description: 
      Vesico-ureteral reflux was the main cause for renal failure and reduced life expectancy in
      patients with neurogenic bladder dysfunction due to spinal cord injury. Neurogenic detrusor
      overactivity leads to high intravesical pressure and may induce reflux. Decreasing
      intravesical pressure and increasing bladder capacity is necessary to prevent reflux and
      secondary renal failure.
    

Intervention name(s): video-urodynamic examination
Intervention type(s): Procedure
Intervention description(s): Assessment of bladder function during video urodynamic determine of incidence degree and localization of vesico ureteral reflux based on the result of video urodynamics
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Ages Eligibility: minimum 18 years Genders Eligibility: female and male
      
Keywords: vesico-ureteral reflux; neurogenic bladder dysfunction; spinal cord injury
Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001
Condition: Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A randomised, double-blind, parallel-group, study comparing the analgesic effect of
      intranasal CT001 to intranasal sufentanil, intranasal ketamine or placebo for treatment of
      acute pain in adults undergoing surgical removal of an impacted mandibular third molar, where
      bone removal is judged to be needed.
    


Intervention name(s): CT001; Placebo; Sufentanil; Ketamine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Intranasal; Intranasal; Intranasal; Intranasal
Intervention MeSH terms: Sufentanil; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Attentional Control
Condition: Attention Control; Healthy Volunteers
Study type: Interventional

Summary: 
      The project is dedicated to understanding the integration within the brain of signals of
      different natures that contribute to attentional control. The investigator will make use of
      standardized experimental displays involving the discrimination of a target (tilted-bar)
      presented together with 3 distractor items, with one stimulus in each visual quadrant. Across
      three fMRI experiments in healthy participants, the investigator will manipulate different
      types of signals that will guide the subject's attention towards one of the four quadrants:
      Exp 1 - task instruction & item salience; Exp 2 - probabilistic target location; Exp 3 -
      probabilistic reward. The investigator expects that irrespective of the nature of the control
      signal, activity in dorsal parietal cortex will index the currently relevant/attended
      location. Moreover, The investigator expects that upon changes of the most relevant location,
      one will observe activation of the ventral parietal cortex, plus increased inter-regional
      connectivity between ventral and dorsal parietal regions - again irrespective of the nature
      of the attention guiding signals.
    


Intervention name(s): Functional brain imaging without any contrast agent
Intervention type(s): Other
Intervention description(s): During the functional magnetic resonance imaging (fMRI) protocol, the subject will perform the attentional task while whole-brain activity will be recorded using Echo Planar Imaging (EPI) that measures the Blood Oxygen Level Dependent (BOLD) signal (2x2x2 isotropic voxels, Echo Time (ET) = 30 ms, Repetition Time (RT) = 2.5 sec). The functional session will be subdivided into several parts ("Runs", duration: 10-15 min). Together with the functional data, the protocol will include a structural scan (T1 weighted, 1x1x1 mm voxels; duration 5-7 min) and a field mapping sequence (duration: 1 min).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Attention; Control; Functional Magnetic Resonance Imaging (fMRI); Parietal; Space
The Effects of Remnant-Preserving Anterior Cruciate Ligament Reconstruction on Proprioception and Functionality
Condition: Anterior Cruciate Ligament Rupture
MeSH terms: Rupture
Study type: Observational

Summary: 
      Anterior cruciate ligament (ACL) reconstruction is a frequently performed surgical procedure
      to stabilize the knee joint biomechanically. At the same time, one of the goals is to improve
      clinical outcomes and return the patient to their daily life as early and ready as possible,
      as well as to sports activities. Remnant-preserving anterior cruciate ligament reconstruction
      is one of the reconstruction approaches that aim to achieve these goals earlier and more
      safely than the standard surgical procedure. However, there is no consensus in the literature
      regarding the effects of remnant-preserving ACL reconstruction on clinical outcomes and its
      superiority over the standard surgical procedure. Therefore, the aim of our study is to
      compare the proprioception and functionality of patients who underwent ACL reconstruction
      with the remnant-preserving approach, by classifying them according to stump size.
    


Intervention name(s): Proprioception assessment, functionality assessment
Intervention type(s): Other
Intervention description(s): Proprioception assessment, functionality assessment
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients who were underwent remnant-preserving anterior cruciate ligament reconstruction
Physical Activity and Cognitive Function in Older Adults: A Novel Role for GPLD1
Condition: Aging; Cognitive Dysfunction
MeSH terms: Cognitive Dysfunction
Study type: Observational

Summary: 
      The investigators are conducting a cross-sectional, observational study to investigate
      whether plasma GPLD1 concentrations are associated with higher cognitive function and better
      brain structure and function in two groups of older adults with high or low levels of
      physical activity.
    

Detailed description: 
      This is a cross-sectional, observational study which will enroll up to 28 healthy, older
      adults (65-85 y, BMI 20-35 kg/m2), and stratify by current self-reported physical activity
      level (equal inactive vs. equal highly active).

      Aim 1: Investigate whether physical activity level is associated with GPLD1.

      Aim 2: Investigate whether cognitive function and brain structure/function are associated
      with GPLD1.
    

Intervention name(s): Brain Health Assessments
Intervention type(s): Behavioral
Intervention description(s): The investigators are enrolling up to 28 healthy, older adults (ages 65-85 y, BMI 20-35 kg/m2) stratified by current physical activity level (equal inactive vs. equal highly active). Each physical activity group (inactive and highly active) will undergo a blood draw, body composition, resting metabolic rate, cognitive testing, and magnetic resonance (MR) imaging.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Up to 28 healthy, older adults (ages 65-85 y, BMI 20-35 kg/m2) stratified by current
        physical activity level will be enrolled. The investigators will enroll an equal number of
        inactive adults and an equal number of highly active adults.
An Integrated Treatment for Comorbid PTSD and Substance Abuse in Adolescents
Condition: Substance Abuse; Traumatic Stress
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      This study plans to develop an integrated treatment for comorbid post-traumatic stress
      disorder (PTSD) and substance abuse (SA) in adolescents. The investigators aim to develop a
      treatment approach that is community-friendly, well-tolerated, and deliverable by substance
      abuse counselors (SAC) in outpatient settings. The proposed Trauma-Focused Substance Abuse
      Treatment (TFSAT) aims to reduce PTSD symptoms and substance use and build coping skills. The
      investigators propose to adapt an evidence-based trauma program, Cognitive-Behavioral
      Intervention for Trauma in Schools (CBITS), for adolescent substance abusers (ASAbusers); to
      assess the acceptability and feasibility of the integrated approach; and to pilot test the
      new program against standard care.

      The investigators hypothesize that the intervention group, compared to the control group,
      will reduce substance use and symptoms for traumatic stress.
    


Intervention name(s): Trauma-focused Substance Abuse Intervention
Intervention type(s): Behavioral
Intervention description(s): An integrated treatment approach to reduce substance use and PTSD symptoms. The intervention program includes: 1) 1-2 individual sessions during which youth talk about the trauma, during the course of the intervention program; 2) 16 group sessions for youth; 3) 2 conjoint sessions with parents to improve communication and problem-solving skills; and 4) 2 parent-education group sessions.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Substance Abuse; Traumatic Stress
Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures
Condition: Epilepsy
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      The main purpose of this trial is to determine safety and efficacy of Lacosamide under long
      term therapy.
    


Intervention name(s): Lacosamide
Intervention type(s): Drug
Intervention description(s): 50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing throughout the trial
Other intervention name(s): SPM 927; LCM
Intervention MeSH terms: Lacosamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety Trial of Subcutaneous Immunotherapy in Mite Induced Asthma
Condition: Allergic Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether a short course of subcutaneous
      immunotherapy is efficacious in mite induced asthma. The efficacy is based on reduction in
      control medication.
    

Detailed description: 
      The control of mild-moderate persistent asthma include the need of concomitant medication, as
      inhaled corticosteroids. However, compliance in perennial asthma is low. The aim of this
      study is to assess the possibility to reduce the need of concomitant medication through a
      short-course of subcutaneous immunotherapy.
    

Intervention name(s): Pangramin Plus D. pteronyssinus 100%
Intervention type(s): Biological
Intervention description(s): Active. Pangramin Plus D. pteronyssinus 100%
Placebo. Pangramin Plus placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Specific immunotherapy; Mite; Asthma
A Study of Multiple Doses of LY2922470 in Participants With Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to determine the safety of LY2922470, taken as oral
      capsules, once or twice daily for approximately 28 days, in participants with diabetes. It
      also aims to determine how long the drug stays in the body and how it affects blood sugar
      levels. A screening appointment is required within 28 days before the start of the study and
      a follow up appointment is required approximately 14 days after the last study dose is taken.
    


Intervention name(s): Placebo; LY2922470
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally as capsules; Administered orally as capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
PK Study to Assess Drug-drug Interaction Between Sitravatinib and a P-gp Inducer and an Inhibitor.
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 Open-label, Two-cohort, One-sequence Crossover Study to Investigate the Effect of P
      glycoprotein Inhibitor (Itraconazole) and Inducer (Rifampin) on the Pharmacokinetics, Safety,
      and Tolerability of Sitravatinib in Healthy Subjects.
    


Intervention name(s): Sitravatinib 50 mg; Sitravatinib 100 mg; Itraconazole; Rifampin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 50 mg Sitravatinib on Day 1 (Group 1A); 100 mg Sitravatinib on Day 1 (Group 2A); Itraconazole QD from Day 9 to Day 18, and Sitravatinib 50 mg at Day 12 (Group 1B); Rifampin QD from Day 9 to Day 22, and Sitravatinib 100 mg at Day 16 (Group 2B)
Other intervention name(s): MGCD516; MGCD516; Protonix; Pepcid
Intervention MeSH terms: Itraconazole; Rifampin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a Phase 1, single-center, open-label, 2-cohort, 1-sequence crossover study to investigate the effect of coadministration of a P glycoprotein (P-gp) inhibitor, itraconazole, (Cohort 1) and a P-gp inducer, rifampin, (Cohort 2) in healthy subjects.
Masking: None (Open Label)
Primary purpose: Other
The Effect on Knee Joint Loads of Analgesic Use Compared With Exercise in Patients With Knee Osteoarthritis - An RCT
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effects of neuromuscular exercise and analgesic
      use on knee joint load, in patients with mild to moderate knee osteoarthritis (OA).

      It is expected that the two groups will receive equipotent pain relieving effect, despite
      this, the investigators expect a between group difference in knee joint load, and the
      exercise group will have a reduction in knee joint load.
    


Intervention name(s): Instruction on analgesic use for pain relief (acetaminophen and NSAIDs); Neuromuscular exercise
Intervention type(s): Drug; Other
Intervention description(s): The PHARMA group receives instruction, by video and pamphlet, on how to best use acetaminophen and NSAID as pain management for knee OA.; The exercise group receives 1 hour of supervised neuromuscular exercise two times a week for 8 weeks. Supervision is conducted by physiotherapists specially trained in using neuromuscular exercise and its principles.
Other intervention name(s): Acetaminophen; Non-Steroid Anti-Inflamatoric Drug:; Ibuprofen; Acetylsalicylic acid; Celecoxib; Dexibuprofen; Etoricoxib; Lornoxicam; Meloxicam; Diclofenac; Etodolac; Indomethacin; Nabumetone; Naproxen; Tenoxicam; Tiaprofenic acid; Dexketoprofen; Exercise; Stability; Alignment; Functional
Intervention MeSH terms: Acetaminophen; Aspirin; Ibuprofen; Celecoxib; Diclofenac; Naproxen; Indomethacin; Etoricoxib; Meloxicam; Dexketoprofen trometamol; Etodolac; Lornoxicam; Nabumetone; Tenoxicam; Tiaprofenic acid; Analgesics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise Therapy; Gait; Joint load; Knee Joint; Middle Aged; Osteoarthritis, Knee/therapy; Pain Management
Therapeutic Effect of Immunoadsorption for Patients With Lipoprotein Glomerulopathy
Condition: Treatment
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy and safety of immunoadsorption in the
      treatment of lipoprotein glomerulopathy.
    

Detailed description: 
      Lipoprotein glomerulopathy is characterized by nephritic syndrome glomerular protein thrombi
      and lipid abnormalities, particularly with an elevated level of plasma apoprotein E
      (apoE).There are no efficiency way to treat lipoprotein glomerulopathy. We firstly
      successfully treat 2 patients by protein A immunoadsorption with remarkable decreased urine
      protein and reduction of lipoprotein thrombi on repeated renal biopsy.
    

Intervention name(s): immunoadsorption
Intervention type(s): Procedure
Intervention description(s): immunoadsorption
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lipoprotein glomerulopathy; treatment; immunoadsorption; apolipoprotein E
Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) in Adolescents in Non-Endemic Area(s)
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to describe the neutralizing antibody response against each
      dengue serotype at 1 month post second dose of TDV or placebo in dengue-naive adolescent
      participants.
    

Detailed description: 
      The vaccine tested in this study was tetravalent dengue vaccine (TDV). TDV was tested to
      assess the safety and immunogenicity in healthy adolescents in non-endemic area(s) for
      dengue.

      The study enrolled 400 healthy participants. Participants were randomized in 3:1 ratio to
      receive:

        -  TDV 0.5 mL subcutaneous injection

        -  Placebo normal saline solution (0.9% NaCl) for injection.

      In each trial group, participants received 2-dose schedule of TDV or placebo by subcutaneous
      injection on Days 1 (Month 0) and 90 (Month 3), but not all participants received both doses
      (8 subjects discontinued the trial before receiving the second dose).

      This multi-center trial was conducted in Mexico. The overall time to participate in this
      study was 270 days. Participants had multiple visits to the clinic including a final visit at
      Day 270.
    

Intervention name(s): Tetravalent Dengue Vaccine (TDV); Placebo
Intervention type(s): Biological; Biological
Intervention description(s): TDV subcutaneous injection; Normal Saline (0.9% NaCl) subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug Therapy