bioihbjkbjnl/mcl2 huggingface dataset:
Melatonin for Huntington's Disease (HD) Gene Carriers With HD Related Sleep Disturbance - a Pilot Study
Condition: Huntington Disease
MeSH terms: Dyssomnias; Parasomnias; Huntington Disease
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the efficacy of exogenous melatonin in improving
      sleep quality in HD gene carriers.
    


Intervention name(s): Melatonin; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Participants will receive melatonin 5 mg once a day (30 min prior to bedtime) for four weeks, followed by one-week washout before crossing-over.; Participants will receive placebo once a day (30 min prior to bedtime) for four weeks, followed by one-week washout before crossing-over.
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Huntington's Disease; Melatonin
Dry Needling, Manipulation and Stretching vs. Manual Therapy, Exercise and Ultrasound for Lateral Epicondylalgia
Condition: Lateral Epicondylitis
MeSH terms: Tennis Elbow
Study type: Interventional

Summary: 
      The purpose of this research is to compare two different approaches for treating patients
      with lateral epicondylalgia: electric dry needling, thrust manipulation and stretching versus
      impairment-based manual therapy, exercise and ultrasound. Physical therapists commonly use
      all of these techniques to treat lateral epicondyalgia. This study is attempting to find out
      if one treatment strategy is more effective than the other.
    

Detailed description: 
      Patients with epicondyalgia will be randomized to receive 2 treatment sessions per week for 4
      weeks (up to 8 sessions total) of either: (1) electric dry needling, thrust manipulation and
      stretching or (2) impairment-based manual therapy, exercise and ultrasound
    

Intervention name(s): Dry Needling, manipulation, stretching; manual therapy, exercise, ultrasound
Intervention type(s): Other; Other
Intervention description(s): HVLA thrust manipulation to elbow, wrist and spine (C5-C6). Dry needling to wrist extensor muscles on the dorsal forearm, proximal and distal of the lateral epicondyle. Up to 8 treatment sessions over 4 weeks.; Impairment-based manual therapy, exercise and ultrasound targeting the wrist extensors on the dorsal forearm, proximal and distal of the lateral epicondyle. Up to 8 treatment sessions over 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Health Related Quality of Life of Youth and Young Adults With Haemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 4

Summary: 
      Research question:

      Whether there are the changes in quality of life in patients with haemophilia A after
      switching from SHL FVIII prophylaxis to efmoroctocog alfa prophylaxis?

      A 12-month prospective open-label, single-arm multicentre study. Evaluation of parameters
      will be carried out on the backdrop of patient treatment in the settings of routine medical
      practice. No medical examinations/ procedures/ treatment(s) on the top of regular medical
      practice are planned, except fixed time of examinations.
    

Detailed description: 
      Quality of life is among the key factors when medical decision about management of
      haemophilia is taken. There are no scientific data on the HRQoL in patients after switching
      from Standard Half Life (SHL) FVIII prophylaxis to efmoroctocog alfa (Extended Half Life,
      EHL) prophylaxis in Russia.

      It will be a 12-month prospective open-label, single-arm multicentre study. Evaluation of
      parameters will be carried out on the backdrop of patient treatment in the settings of
      routine medical practice. No medical examinations/ procedures/ treatment(s) on the top of
      regular medical practice are planned, except fixed time of examinations. Providing the
      centers/ patients with the study drug (efmoroctocog alfa) may be considered as interventional
      component, whereas all administrations should be in accordance with Instruction on Medical
      Use approved by Russian Ministry of Health.

      Research question:

      Whether there are the changes in quality of life in patients with haemophilia A after
      switching from SHL FVIII prophylaxis to efmoroctocog alfa prophylaxis?

      No hypothesis is formulated for this exploratory study. The obtained data will be used to
      assess real world data on quality of life and clinical outcomes in patients with haemophilia
      A after switching from SHL FVIII prophylaxis to efmoroctocog alfa prophylaxis in routine
      medical practice in Russia
    

Intervention name(s): Efmoroctocog Alfa Injection [Eloctate]
Intervention type(s): Drug
Intervention description(s): Efmoroctocog alfa should be administered according to Summary of Product Characteristics (SmPC)/ Instruction on Medical Use approved by Russian Ministry of Health ЛП-006034 (13.01.2020).
Intervention MeSH terms: Factor VIII; Immunoglobulin Fc Fragments
Intervention model: Single Group Assignment
Intervention model description: A 12-month prospective open-label, single-arm multicentre study.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Haemophilia A; Health-related Quality of Life; Efmoroctocog alfa
Calcium Hydroxide, Mineral Trioxide Aggregate and Biodentine (Trademark) as Direct Pulp Capping of Permanent Teeth
Condition: Caries; Dental Pulp Exposure
MeSH terms: Dental Pulp Exposure
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Background: Dental caries is considered an oral health problem worldwide. In Chile the last
      national epidemiological study (2007) showed a national prevalence of dental caries in
      children 6 years (70.3%) and 12 (62.5%). Direct pulp capping is a preventive dental therapy,
      keeps the vitality of the tooth using some inductive materials mineralized tissue formation.

      Objective: The main objective of this study is to evaluate the effectiveness of two
      innovative direct pulp capping materials; Biodentine compared MTA and calcium hydroxide in
      the maintenance of pulp vitality in teeth permanent molars.
    

Detailed description: 
      Methodology: It is a randomized controlled study. groups signed the informed consent for
      clinical trial patients, a clinical evaluation of 90 permanent molars teeth through
      endodontic diagnostic tests and radiograph. will be conducted to determine diagnosis. Will be
      assigned randomly to the type of material to use and direct pulp teeth affected by caries
      coating is carried out; Patients will not have knowledge of the material to be used in the
      coating. The patient will be clinically evaluated at 1 week, 3 months and 8 months, and
      radiographically; at the beginning and end of the study. In each clinical control endodontic
      diagnostic tests of heat, cold, electric and percussion will be performed. In radiographic
      controls take a radiograph control with positioner or surveyor at baseline and 8 months, to
      evaluate the periapical status. Clinical success will consider that tooth in continuous
      controls and after 8 months presented vitality and radiographic signs of apical image without
      injury. Failure unresponsive to consider whether susceptibility testing of cold and
      electricity in more than one control and presents radiographic image with apical lesion.
    

Intervention name(s): Mineral trioxide aggregate; Calcium hydroxide; Biodentine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Mineral trioxide aggregate; Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material.; Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.
Other intervention name(s): MTA Pro Root; Calcium hydroxide Hertz; Active biosilicate. Septodont.
Intervention MeSH terms: Calcium, Dietary; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: dentin substitute; vital pulp therapy; Biodentine; caries
Effect of Hepatic and Renal Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1841788 (ODM-201)
Condition: Pharmacokinetics; Hepatic Insufficiency; Renal Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the potential effect of hepatic or renal impairment on the pharmacokinetics, safety
      and tolerability of BAY 1841788 (ODM-201).
    

Detailed description: 
      The study was closed after Part 1 because additional investigation in volunteers with
      moderate renal impairment in Part 2 was not deemed to be ethically or scientifically
      justified.
    

Intervention name(s): BAY1841788
Intervention type(s): Drug
Intervention description(s): 600 mg single dose, administered as 2 x 300 mg tablets on Day 00.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effects Of Whole Body Vibration On Postural Control In Patients With Ataxia
Condition: Ataxia
MeSH terms: Ataxia
Study type: Interventional

Summary: 
      To investigate the effects of whole body vibration on postural control and on the level of
      satisfaction regarding how to reach the goals of the patients with ataxia
    

Detailed description: 
      Patients will be randomly assigned to 2 groups, group 1 will take only exercise therapy,
      group 2 will take exercise therapy and whole body vibration together. After 1 week wash-out
      period, patients assigned other therapy period. All assessments will be repeated before and
      after each therapy period. Exercise therapy will consist of selected balance, coordination
      and walking exercises according to the individual needs of patients. Whole body vibration
      (20-30 Hz, minimum amplitude) will be applied to cases in the form of 4 sets (1 min
      application and 1min rest.) Cases will take the treatment 1-hour, 3 days in a week for 8
      weeks.

      The evaluation parameters consists of demographic information, Computerized Dynamic
      Posturography, International Cooperative Ataxia Rating Scale, Trunk Impairment Scale, Berg
      Balance Scale, Barthel Index and Goal Assessment Scale.
    

Intervention name(s): Exercise therapy; Whole body vibration
Intervention type(s): Other; Other
Intervention description(s): Cases will take the treatment 1-hour, 3 days in a week for 8 weeks.; 4 sets, 1 min application and 1min rest whole body vibration and after that exercises. Cases will take the treatment 1-hour, 3 days in a week for 8 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Exercise Training and Glucose Metabolism in Aging
Condition: Type 2 Diabetes Mellitus; Impaired Glucose Tolerance (Prediabetes)
MeSH terms: Diabetes Mellitus, Type 2; Glucose Intolerance
Study type: Interventional

Summary: 
      Diabetes and its associated complications affect more than 20 million Americans, and the
      prevalence of type 2 diabetes and impaired glucose tolerance rises dramatically with age such
      that 40% of Americans over age 60 are affected. In older adults, glucose metabolism may be
      affected by reduced skeletal muscle capillary supply, which limits insulin, glucose, and
      oxygen delivery to skeletal muscle. Reduced capillary supply to skeletal muscle is found in
      older individuals with impaired glucose tolerance and we hypothesize that this is due to
      reduced vascular growth factor expression, and chronic inflammation. Further, we hypothesize
      that reversal of a sedentary lifestyle through aerobic exercise training will increase
      insulin signaling and vascular growth factor expression, as well as decrease inflammation, to
      increase capillary supply to skeletal muscle, which contributes to improved glucose
      metabolism in older adults. This study will: 1) Determine the mechanisms underlying reduced
      skeletal muscle capillarization in older adults with impaired glucose tolerance; and 2)
      Determine the effect of aerobic exercise training-induced increases in skeletal muscle
      capillarization on glucose metabolism in older adults.
    


Intervention name(s): Aerobic exercise training; Detraining (cessation of exercise)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 24 weeks of aerobic exercise training: 3 times per week, 60 minutes per session, at 70% of maximal aerobic capacity; Cessation of exercise for 2 weeks
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
CHinese Acute Tissue-Based Imaging Selection for Lysis In Stroke -Tenecteplase II
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      To explore the efficacy and safety of tenecteplase for acute ischemic stroke patients (onset
      time 4.5-24h) of large vessel occlusion using early combined CT/MR imaging outcomes
    


Intervention name(s): Tenecteplase; The best treatment selected by local doctors(Aspirin, Recombinant Tissue Plasminogen Activator, Urokinase, Thrombectomy)
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous (IV) tenecteplase 0.25 mg/kg (single bolus; maximum dose 25 mg); Best treatment arm
Intervention MeSH terms: Aspirin; Plasminogen; Tissue Plasminogen Activator; Tenecteplase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: acute ischemic stroke; large vessel occlusion; thrombolysis; tenecteplase; dosage; computed tomography; magnetic resonance imaging; diffusion weighted imaging; early combined imaging outcomes; modified Rankin scale; time window beyond 4.5 hours
Investigation of the Effects of Obesity Surgery on Appetitive Behaviour
Condition: Roux-en-Y Bariatric Surgery
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Among all the existing ways to treat obesity (lifestyle, pharmacological), Roux-en-Y gastric
      bypass (RYGB) surgery is currently the most effective. It results in long term weight loss
      maintenance, significant remission of obesity-related comorbidities and decreased overall
      mortality. It also induces changes in gastrointestinal hormones responses, with an increase
      of anorexigenic hormones GLP-1, and PYY.

      Although successful, the mechanisms for RYGB-induced weight loss are not completely
      understood. The RYGB does result in increased satiation, decreased calorie intake and
      decreased preferences for sweet and fatty foods. Previous work from our lab has shown using
      progressive ratio task (PRT) that RYGB specifically decreases the appetitive behaviour for
      sweet and fat stimuli but not for vegetables. The reasons for this change in appetitive
      behaviour after the surgery remain unknown. They may be triggered by changes in gut hormones,
      conditioned taste aversion (negative post-ingestive effects) or changes in serum bile acids
      levels.

      This study aims to assess whether RGYB-induced gut hormone changes contribute to the decrease
      in appetitive behaviour for sweet and fatty foods observed after the surgery.

      This is a double blind controlled study comparing the effect of blocking gut hormones with
      somatostatin analogue (octreotide) on the appetitive behaviour for sweet-fat candies will be
      carried out. Appetitive behaviour will be measured using the progressive ratio task.

      The investigators hypothesize that blocking the gut hormones in obese patients with RYGB will
      increase their appetitive behaviour for sweet-fat candies.
    


Intervention name(s): Octreotide; Saline
Intervention type(s): Drug; Drug
Other intervention name(s): Octreotide 100 micrograms/1ml - solution for injection - Hospira - Q64021; Sodium chloride 0.9% W/V injection BP - Fannin - PL 24598/0002
Intervention MeSH terms: Octreotide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: RYGB; Bariatric surgery; Taste; Reward; Food behaviour; Gut hormones
Topical Compound Tripterygium Wilfordii Hook F for Patients With Active Rheumatoid Arthritis
Condition: Active Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      Rheumatoid Arthritis (RA) is an autoimmune disease that results in a chronic inflammatory
      disorder that may affect many synovial joints, and may cause serious disability. It has been
      confirmed that Tripterygium wilfordii Hook F has effects of anti-inflammatory,
      immunosuppressive and cartilage protection. This is a prospective randomized controlled study
      to evaluated the efficacy and safety of external application with compound Tripterygium
      wilfordii Hook F in treating of patients with rheumatoid arthritis (RA).
    


Intervention name(s): Topical compound tripterygium; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Topical compound tripterygium was applied for the pain and swollen joints on non-woven fabric for 1 hour, twice per day.; The topical placebo recipe composes viscous agent which matches by the sucrose, and the usage and dosage were the same as the topical compound tripterygium group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Occlusal Forces and Muscle Activity in Fixed Versus Removable Mandibular Implant Supported Overdenture
Condition: Occlusion
Study type: Interventional

Summary: 
      22 Patients having lower completely edentulous mandible aged 55-60 years were selected from
      the outpatient dental clinic of the Medical Excellence Centre of the National Research (NRC)
      Cairo, Egypt. Six dental implants were inserted in the mandible of each patient.

      The patients were randomly categorized into two groups according to the final restoration.
    

Detailed description: 
      Group I: received a complete removable mandibular implant supported overdenture. While Group
      II: received implant supported fixed bridge.

      Occlusal equilibrations, Muscle activities, and oral health-related quality of life (OHRQoL)
      were assessed by at the time of prosthesis insertion, after one and three month.
    

Intervention name(s): dental implants (K1 line conical connection double thread, OXY, Italy); Occlusense (Bausch GmbH & Co. KG); electromyography (EMG) (Nemus II)".; oral health-related quality of life (OHRQoL)
Intervention type(s): Procedure; Device; Device; Other
Intervention description(s): Six dental implants inserted on the edentulous mandible; sensor used to evaluate the equilibration of occlusal forces.; EMG recordings were accomplished by a computer electromyography-based data acquisition system; Oral Health-related Quality of Life (OHRQoL) was estimated by employing the Oral Health Impact Profile questionnaire which comprises nineteen multiple questions that were translated into Arabic.
Other intervention name(s): Assessment of Muscle Activity by electromyography (EMG) (Nemus II)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: two group Group I: received a complete removable mandibular implant supported overdenture. While Group II: received implant supported fixed bridge.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: implant supported overdenture; muscle activity
Comparison of Concentration of Vasopressin During Robot-assisted Laparoscopic Myomectomy
Condition: Uterine Leiomyoma
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effect of the concentration of vasopressin, which
      is used as a method for reducing blood loss in robot-assisted laparoscopic myomectomy.
    

Detailed description: 
      This study is to compare the effect of the concentration of vasopressin, which is used as a
      method for reducing blood loss in robot-assisted laparoscopic myomectomy. We would like to
      evaluate the feasibility and validity of this study for future Phase III randomized clinical
      trials through this preliminary randomized assignment study.

      Uterine fibroids are the most common tumors in women, and uterine myomectomy, which is
      performed as a treatment for them, is basically a high risk of bleeding and blood
      transfusion. A common method to reduce intraoperative bleeding is to inject diluted
      vasopressin into the subserosal areas of the fibroids. However, no proper level of
      vasopressin dilution has been determined so far, so we want to determine an effective
      dilution concentration of vasopressin that can minimize side effects through this clinical
      trial.
    

Intervention name(s): Vasopressin
Intervention type(s): Drug
Intervention description(s): During robot-assisted laparoscopic myomectomy, vasopressin diluted to different concentrations will be injected before uterine serosal incision.
Other intervention name(s): Vasopressin 20U
Intervention MeSH terms: Vasopressins; Arginine Vasopressin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Leiomyoma; Uterine fibroid; Uterine Myomectomy; Hemostasis; Vasopressin; Dilution