bioihbjkbjnl/mcl2 huggingface dataset:
Treatment Of Gastroesophageal Reflux Disease By Endoscopic Fundoplication, A Placebo-Controlled Study
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 3

Summary: 
      Aim:

      To evaluate the therapeutic efficacy of a therapeutic procedure, involving endoscopic
      suturing, for gastroesophageal reflux disease (GERD) compared to a sham procedure.

      The hypotheses tested in this study were that active treatment would: 1) decrease the use of
      antisecretory medication, 2) decrease GERD symptoms, 3) improve quality of life, and 4)
      reduce esophageal acid exposure.
    

Detailed description: 
      Gastroesophageal reflux disease (GERD) and the chronic, often lifelong, use of antisecretory
      medication have great clinical and economical implications for the patient, practicing
      physician and society in general. The currently available medication in GERD is very
      effective against heartburn, but less against the symptom of regurgitation. Surgical
      antireflux treatment offers a good alternative. The current surgical approach, a laparoscopic
      fundoplication, is safe and effective (a 90% reduction in use of antireflux medication), but
      in a significant subgroup of patients new symptoms arise (dysphagia, bloating) and
      perioperative morbidity, as well as financial costs are relatively high.

      An endoscopic suturing system has been developed, offering a minimally invasive antireflux
      treatment, which can be performed in an outpatient setting. The procedure aims to create an
      endoscopic fundoplication, and could possibly serve as an alternative to antireflux
      medication and surgery. Recent, uncontrolled studies, have shown that the results of the
      endoscopic suturing system are satisfactory and that the procedure is safe.

      This single-center, double-blinded, randomized, sham-controlled trial was conducted to
      evaluate the efficacy of endoscopic gastroplication by the Endocinch suturing system. Sixty
      patients with daily symptoms of GERD and abnormal esophageal 24-hr pH monitoring were
      randomly assigned to three endoscopic gastroplications (n = 20), to a sham procedure (n = 20)
      or to observation (n = 20). Primary endpoints were proton pump inhibitor use and GERD
      symptoms. Secondary endpoints were quality of life, 24-hr esophageal acid exposure,
      esophageal manometry and the occurrence of adverse events. Follow-up assessments were
      performed at 3 months. The research nurse and patients in the active and sham groups were
      blinded to the procedure assignment.
    

Intervention name(s): Endoscopic gastroplication
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Endoscopic antireflux treatment; GERD; Sham-controlled; Endocinch
The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Revision Knee Arthroplasty
Condition: Postoperative Pain; Knee Arthroplasty
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether Adductor-Canal-Blockade is effective at
      reducing pain and morphine consumption after revision knee arthroplasty.
    


Intervention name(s): Adductor-Canal-Blockade with Ropivacaine; Adductor-Canal-blockade with saline
Intervention type(s): Procedure; Procedure
Intervention description(s): US-guided Adductor-Canal-Blockade with ropivacaine 7,5 mg/ml; US-guided Adductor-Canal-blockade with saline
Other intervention name(s): Naropine; Postoperative pain; US-guided nerve block; Placebo block
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adductor-Canal-Blockade; postoperative pain; US-guided nerve block; revision knee arthroplasty
Study to Evaluate the Concentration of Denosumab in Seminal Fluid in Healthy Men After a Single Subcutaneous Dose
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1b, open-label, single dose study in healthy male subjects. Approximately 12
      healthy male subjects will receive a subcutaneous injection of denosumab on Day 1. Subjects
      will be followed by a 105 day treatment-free follow-up period.
    


Intervention name(s): Denosumab
Intervention type(s): Biological
Intervention description(s): 60 mg
Other intervention name(s): Prolia (R)
Intervention MeSH terms: Denosumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Study of OP-1 Putty in Uninstrumented Posterolateral Fusions
Condition: Degenerative Lumbar Spondylolisthesis
MeSH terms: Spondylolisthesis
Study type: Observational

Summary: 
      This study is to provide additional data to support the safety and efficacy of OP-1 Putty as
      a replacement for autograft in patients undergoing posterolateral spinal fusion.
    

Detailed description: 
      Follow-up study 06-UPLF-01 was a prospective collection of longer-term data on the patient
      population from pivotal study S01-01US, and was conducted to expand the information regarding
      efficacy, particularly with regard to radiographic assessment of fusion, as well as the
      longer-term safety of OP-1 Putty in uninstrumented posterolateral fusion (PLF) as compared to
      autograft
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients treated in clinical protocol S01-01US
      
Keywords: Degenerative disc disease
Short-term Health Benefits of Using Fresh Air Filtration System in Classroom
Condition: Airway Morbidity; Cognitive and Attention Disorders and Disturbances; Oxidative Stress
MeSH terms: Cognition Disorders
Study type: Interventional

Summary: 
      A randomized crossover trial will be conducted in 90 primary school children in 3 classrooms
      in Shanghai, China. The effects of fresh air ventilation/filtration system, fresh air
      ventilation system with no filtration and natual ventilation will be compared on the effects
      of reducing indoor PM2.5 and chilhood health. Biological samples of children are going to be
      collected to investigate the associations between indoor air pollution and biomarkes of
      certain health effects.
    

Detailed description: 
      A randomized crossover trial among 90 primary students in 3 classrooms in Shanghai, China
      will be performed. Three arms are going to be 1) fresh air filtration system, 2) fresh air
      system with no filtration and 3) natural ventilation. Each arm is going to be in use for five
      continuous weekdays followed by one week of wash-out. After one-week of wash out, a cross
      over change between 3 arms is going to be taked. Then the 2nd week of intervention is
      performed followed by the 2nd wash-out week. The same cross-over change between 3 arms is
      going to be repeated again until each classroom will be applied by all three arms of
      ventilation. A total of 5 weeks is required for the project. Children's biological samples
      including saliva, urine and skin samples will be collected as well as exhaled NO. A
      questionnaire on children's perception on air quality will be assessed as well.
    

Intervention name(s): Fresh air system with filtration
Intervention type(s): Device
Intervention description(s): Using fresh air ventilation combined with PM2.5 filtration system to reduce the indoor PM2.5 concentration in primarty school classrooms
Other intervention name(s): mechanical ventilation and filtration system
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: exhaled nitric oxide; Sick building syndrome; indoor air
Diabetes Mellitus and Periodontitis and Vitamin D Supplementation
Condition: Diabetes Mellitus Type 2 With Periodontal Disease
MeSH terms: Periodontitis; Periodontal Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study investigates the clinical and biochemical results of vitamin D supplementation in
      addition to non-surgical periodontal treatment in individuals with Type II diabetes mellitus
      and periodontitis.
    

Detailed description: 
      38 individuals with T2DM and periodontitis were included into the study. Clinical periodontal
      measurements including probing depth, clinical attachment level, plaque and gingival indices
      were recorded The individuals included in the study were divided into two groups: Individuals
      given D3K2 with periodontal therapy were included in the test group, and individuals given
      placebo with periodontal therapy were included in the control group. All serum and gingival
      crevicular fluid samples from individuals who underwent non-surgical periodontal treatment
      were taken again at 3rd and 6th months, and clinical periodontal measurements were recorded.
      Glycated hemoglobin A1c (HbA1c), fasting blood glucose (FBG), 25(OH)D3, parathyroid hormone
      (PTH), calcium (Ca) and magnesium (Mg) values were determined in serum samples. GCF and serum
      IL-1ß and IL-10 values were analyzed by enzyme-linked immunosorbent analysis (ELISA).
    

Intervention name(s): Vitamin D3K2; Saline Solution
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Non-surgical periodontal treatment was applied to all individuals included in the study. 2 drops of the preparation containing 25 µg D3 [1000 IU] and 11.25 µg K2 in each drop were given per day to participants in the test group.; Non-surgical periodontal treatment was applied to all individuals included in the study and saline solution (0.9% NaCl) was given as placebo, 2 drops per day to particiapants in the control group.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Periodontitis; Type 2 periodontitis; 25(OH)D3; HbA1c
A Study in Healthy Men to Find Out How BI 425809 is Taken up and Handled by the Body
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial intends to investigate the basic pharmacokinetics of BI 425809 and [14C]-
      radioactivity, including mass balance, excretion pathways and metabolism following a single
      oral dose of 25 mg BI 425809 (C-14) given to healthy male subjects
    


Intervention name(s): BI 425809 mixed with [C-14] BI425809
Intervention type(s): Drug
Intervention description(s): Oral Solution
Intervention MeSH terms: BI 425809
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Robotic-assisted Training After Upper Arm Fracture
Condition: Shoulder Injury
MeSH terms: Shoulder Injuries; Humeral Fractures
Study type: Interventional

Summary: 
      In this study, patients with upper arm fracture will receive an additive robotic-assisted
      training using the Armeo®Spring robot for three weeks on the injured arm in addition to
      conventional physio- and occupational therapy. The supportive treatment and execution of
      specific exercises on the Armeo®Spring should lead to improved recovery of function and
      mobility of the upper arm compared to conservatively treated patients.
    

Detailed description: 
      60 Patients aged between 35 and 70 years with proximal humeral fracture and surgical
      treatment will be recruited in three different clinics in Germany and randomised into an
      intervention and a control group. Participants will be assessed before randomisation and
      followed up after completing an intervention period of 3 weeks and additionally after 3, 6
      and 12 months. Baseline assessment will assess cognition (SOMC), level of pain in the
      affected arm, ability to work, gait speed (10m walk), disability of the arm, shoulder and
      hand (DASH), as well as the range of motion of the affected arm (goniometer measurement),
      visual acuity and motor function of orthopaedic patients (WMFT-O). Clinical follow up
      directly after intervention will assess disability of the arm, shoulder and hand (DASH), the
      range of motion and motor function (WMFT-O). Primary outcome parameter will be the DASH and
      secondary outcome parameter will be the WMFT-O. The long-term results will be assessed
      prospectively by a postal follow-up. All patients will receive conventional occupational- and
      physiotherapy. The intervention group will receive an additive robotic-assisted training
      using the Armeo®Spring robot for three weeks.
    

Intervention name(s): Intervention Armeo®Spring; Control Group
Intervention type(s): Other; Other
Intervention description(s): The robotic-assisted training will be performed using the clinically evaluated Armeo®Spring medical device (Hocoma AG, Zurich, Switzerland). By means of a sensory orthosis, arm movements will be supported and transmitted to a computer system and visually shown on a screen.; The control group will receive conventional occupational- and physiotherapy over 3 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be recruited in three different clinics in Germany and randomised into an intervention and a control group. All patients will receive conventional occupational- and physiotherapy. The intervention group will receive an additive robotic-assisted training using the Armeo®Spring robot for three weeks.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: robotic-assisted rehabilitation; humeral fracture; randomised controlled study
Follow-up of the Patients Included in the EXESAS Study
Condition: Sleep Apnea Syndromes; Sleep Apnea, Obstructives
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Sleep apnoea affects more than 20% of people over 65 years and is largely underdiagnosed. It
      does multiply tenfold the occurrence of vascular events, particularly stroke. While
      Continuous Positive Airway Pressure (CPAP) is currently the Gold standard treatment to
      prevent cerebrovascular and cardiovascular events, with a major clinical benefit, long term
      adherence to CPAP is a significant problem and search for alternative treatment is essential.
    

Detailed description: 
      In the previous EXESAS study (NCT02463890) the investigators compare evolution of Apnea
      Hypopnea Index (AHI) in an exercise trained group performed through in a national based
      non-profit organization (Fédération Française d'éducation Physique et de Gymnastique
      Volontaire (FFEPGV)) using a medical established program (NeuroGyV) during nine months
      against a control group receiving only standard dietetic and physical activity counseling.

      The first partial observations of the study EXESAS seem encouraging in the term of 3 months
      of training. However, in the longer term, there is not a coverage in the treatment of the
      moderate Sleep Apnea: Obstructive Syndrome (SAOS). Thus they can logically expect that the
      possible therapeutic effect of the exercise is not maintained in the long term after the stop
      of the training.

      This nex study suggests studying the profit of the exercise on sleep apneas for the patients
      who were initially in the control group in the EXESAS study and to observe if the
      preservation of a regular physical activity for the group which was trained in EXESAS study
      is associated with a preservation of the AHI after the additional year of follow-up without
      additional intervention
    

Intervention name(s): Training; Control
Intervention type(s): Other; Other
Other intervention name(s): NeuroGyV program
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Sleep Apnea Syndromes; Sleep Apnea, Obstructives; Training
PECBLOCK for the Treatment of Pain After Breast Surgery
Condition: Cancer; Pain
Study type: Interventional

Summary: 
      Pain after breast cancer surgery could be severe and about 1/3 of patients will develop
      chronic pain. The PECBLOCK is the injection of local anesthetics between the two pectoral
      muscles to block pectoral nerves and intercostal nerves innervating the breast. The aim of
      this study is to evaluate the efficacy of the PECBLOCK performed under echoguidance in minor
      and major breast surgery. The prevention of chronic pain following surgery will also be
      evaluated.
    


Intervention name(s): PECBLOCK under echoguidance
Intervention type(s): Procedure
Intervention description(s): Performance of block under echography
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative pain; Chronic pain prevention; Regional anesthesia; Mastectomy
Effects of THC and CBD on Human Episodic Memory Function
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      THC and CBD have distinct symptomatic and behavioral effects. In healthy individuals, THC can
      induce psychotic symptoms and anxiety, and can impair memory. In contrast, CBD has anxiolytic
      and possibly antipsychotic properties, while not impairing memory and other cognitive
      functions. Instead, CBD has been shown to have significant neuroprotective effects. In
      humans, CBD values correlated positively with gray matter concentration in bilateral
      hippocampus. Recent data from experimental animals and in vitro studies suggest that these
      distinct effects might be caused by opposing effects on brain cannabinoid receptors.

      Neuroimaging studies have consistently identified brain activity recorded at prefrontal and
      medial temporal regions as relevant for episodic memory. Additionally, the abundance of
      cannabinoid receptors in the hippocampus and the parahippocampal and entorhinal cortices
      suggests a potential impact of CBD in memory deficits typical in healthy aging. However, the
      evidence relating cannabinoids to these conditions is relatively recent and has been obtained
      from either biochemical or pharmacological studies. It might be hypothesized that CBDs could
      be useful to delay or even arrest the progression of functional and structural neuronal
      degeneration.

      The investigators will use an episodic memory paradigm to test the effects of THC, CBD and
      placebo on memory encoding and retention and the underlying neuronal networks on healthy male
      subjects.
    


Intervention name(s): Tetrahydrocannabinol; Cannabidiol; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 mg Tetrahydrocannabinol (capsule, once) oral intake; 600 mg Cannabidiol (capsule, once) oral intake; placebo (capsule, once) oral intake
Intervention MeSH terms: Dronabinol; Cannabidiol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Tolerability and Steady-state Pharmacokinetics of BIA 6-512
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the tolerability and safety of four multiple-dose regimens of BIA 6-512 (25
      mg, 50 mg, 100 mg, and 150 mg 6 times daily) in healthy volunteers and to characterise the
      steady-state pharmacokinetic profiles of BIA 6-512 (25 mg, 50 mg, 100 mg, and 150 mg 6 times
      daily) in healthy volunteers.
    

Detailed description: 
      Single-centre, double-blind, randomised, placebo-controlled study of four multiple-rising
      doses in four sequential groups of 10 healthy volunteers each. Eligible subjects were
      admitted to the UFH on the day (Day 0) prior to receiving the first dose of study medication.
      On the morning of the next day (Day 1), subjects started receiving BIA 6-512/Placebo at 4 h
      intervals (6 times/day) for 48 h (13 investigational product administrations, in total).
      Subjects remained confined in the UFH from admission (Day 0) until at least 24 h post last
      dose (Day 4); then, they were discharged and were requested to return for the follow-up
      visit. At given time-points, subjects were submitted to vital signs recording, brief
      neurological examination, and 12-lead ECG. Blood samples for plasma drug assays were taken at
      the following times: Dose 1: pre-dose and ¼, ½, ¾, 1, 1½, 2, and 3 hours post-dose; Doses 2,
      3, 4, 5, 7, 8, 9, 10, 11: pre-dose; Dose 13: pre-dose and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12,
      16 and 24 hours post-dose.
    

Intervention name(s): BIA 6-512; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The investigational products consisted of capsules containing BIA 6-512 25 mg, 50 mg, 100 mg and 150 mg. Products were administered orally, with approximately 240 mL of water in case of Doses 1 and 13, and at least 150 mL of water in case of Doses 2 to 12. First dose (Dose 1) and last dose (Dose 13) were administered in fasting of at least 8 hours and subject remained fasted until to 2.5 h post-dose. Meals were not served within 1 hour prior and 1 hour after investigational product administration in Doses 2 to 12; Matching placebo capsules
Other intervention name(s): Trans-resveratrol
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Evaluate Safety and Tolerability of ACT-709478 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the safety and tolerability of ascending
      multiple doses of ACT-709478 in healthy male and female subjects
    


Intervention name(s): ACT-709478; Placebo; Midazolam; ACT-709478 combined with midazolam
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Hard gelatine capsules for oral administration; Placebo capsules matching ACT-709478 capsules; Midazolam oral solution (2 mg/mL) applied with a syringe; Hard gelatine capsules for oral administration (ACT-709478) to be taken first followed by Midazolam oral solution (2 mg/mL) applied with a syringe
Intervention MeSH terms: ACT-709478; Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: tolerability; safety