bioihbjkbjnl/mcl2 huggingface dataset:
Biomarkers and Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      High joint load during walking has been linked to cartilage degradation. Biomarkers, found in
      the blood and urine, are protein fragments released after cartilage degradation
      characteristic of OA. They have the potential to enable direct and immediate disease state
      monitoring and identification of early cartilage changes. Little is known about the
      association of biomarkers with joint load or if exercise aimed at reducing joint load changes
      biomarker levels, thus reducing the risk of OA progression. This study will provide novel
      information on these relationships and will guide future intervention studies. The
      investigators hypothesize that certain biomarkers will be highly correlated with joint
      loading during walking and that the levels of these biomarkers in the blood and urine will
      decrease following an exercise intervention aimed at cartilage unloading.
    

Detailed description: 
      Participants will be tested twice (baseline and 11 weeks later) where they will undergo gait
      and strength analyses by the same blinded assessor, complete self-report questionnaires, and
      have blood and urine samples drawn. Participants will then be randomized into either: (i)
      exercise; or (ii) usual care (no additional treatment). Those in the exercise group will
      complete 10-weeks of strengthening targeting lower limb muscles. Once weekly, they will
      consult with the study physiotherapist (MAH) at UBC to ensure proper performance and safe
      progression of exercises. Participants will be given cuff weights and resistance bands to
      complete exercises at home five times per week. Exercise compliance will be monitored using
      log books. All participants will be encouraged to maintain their usual treatment regimen
      (except for exercises completed by the exercise group), but will document any unexpected
      alterations such as medication changes or physician visits.
    

Intervention name(s): Lower limb muscle strengthening
Intervention type(s): Behavioral
Intervention description(s): Participants in the exercise group will receive a lower limb strengthening program consisting of 6 exercises targeting the quadriceps, hamstrings, and hip abductor groups. They will perform these exercises at home 4 times per week (3 sets of 10 repetitions per exercise). Over the course of the intervention, each participant will consult with the physiotherapist a total of 5 times (once per week in weeks: 1,2,3,5, and 8) to ensure proper performance of exercises and safe progression of resistance.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: knee; osteoarthritis
Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling
Condition: Alopecia; Breast Cancer
MeSH terms: Breast Neoplasms; Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      Persistent alopecia following adjuvant docetaxel for breast cancer is a side-effect that has
      been recently described. This pilot trial explores the capacity of a cooling cap (Elasto-gel)
      to prevent persistent alopecia in breast cancer patients treated with adjuvant docetaxel
      regimens.
    

Detailed description: 
      Persistent alopecia following adjuvant docetaxel for breast cancer is a side-effect that has
      been recently described. Docetaxel is toxic to skin and skin annexes and can produce nail
      toxicity and persistent alopecia. Nail toxicity has been successfully prevented by means of
      hypothermic gloves and slippers (Elasto-gel, Southwest Technologies, Inc, North Kansas City,
      MO). This pilot trial explores the capacity of a cooling cap (Elasto-gel) to prevent
      persistent alopecia in breast cancer patients treated with adjuvant docetaxel regimens.
    

Intervention name(s): elasto-gel cap
Intervention type(s): Device
Intervention description(s): scalp cooling cap
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: persistent alopecia; docetaxel; breast cancer
A Spinal Functional Magnetic Resonance Imagine (fMRI) Study of Resting-State, Motor Task and Acupoint Stimulation
Condition: Cerebral Infarction
MeSH terms: Cerebral Infarction; Infarction
Study type: Observational

Summary: 
      The spinal cord is a very important part of the central nervous system. fMRI can be applied
      to observe functional status of the human spinal cord. Under different conditions, the
      investigators will see different types of fMRI signals within the spinal cord. In resting
      state, the investigators might see active/inactive signals, too.
    


Intervention name(s): motor task, sensory stimulation
Intervention type(s): Other
Intervention description(s): motor task: finger tapping, simple type and complex type
sensory stimulation: electric or tactile stimulation
Other intervention name(s): group 1:healthy people; group 2:patients with cerebral infarction,chronic stage
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        group 1: male residents of Beijing group 2: male stroke patients of Beijing Boai hospital
      
Keywords: fMRI; spinal cord; human; health; cerebral infarction; healthy
Efficacy of Agomelatine in Patients With Obsessive-Compulsive Disorder
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will evaluate the efficacy of agomelatine compared to placebo on the reduction of
      Obsessive and Compulsive symptoms after 16 weeks of treatment.
    


Intervention name(s): Agomelatine A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Agomelatine 25 mg film-coated tablet
Agomelatine 2x25mg film-coated tablet; Placebo
Intervention MeSH terms: Agomelatine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obsessive Compulsive Disorder; Agomelatine
A Food Effect Study to Evaluate the Pharmacokinetics of ASP1517
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the effect of food on the pharmacokinetics of a
      single oral dose of ASP1517 in non-elderly healthy adult male subjects.
    


Intervention name(s): ASP1517
Intervention type(s): Drug
Intervention description(s): Oral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; ASP1517; Food effect
Impact of a Conservative Treatment in the Waiting List for Carpal Tunnel Syndrome Surgery.
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      STC is considered one of the most prevalent peripheral neuropathy of the upper quadrant.
      Systematic review shows that conservative treatment is effective for treatment of CTS. In
      Spain, most patients diagnosed by CTS are included in surgery list without considering
      conservative treatment as first option or providing drugs or night splint . However, surgical
      treatment is not always necessary for these patients, and waiting list delays can lead to
      aggravation of patients' symptoms.

      Researches believe that performing a conservative treatment including diacutaneous fibrolysis
      on carpal tunnel syndrome patients, could reduce waiting surgery list, reduce the
      cost-effectiveness rate of the surgical process and improve patient's satisfaction and
      clinical findings. In addition, patients of any level of severity and with systemic pathology
      will be included to define which patients would benefit from surgical treatment and which
      from physiotherapeutic treatment.

      The aim is to find out the impact of a multimodal physiotherapy treatment in patients with
      Carpal Tunnel Syndrome (CTS) on the patient and the Aragonese Health System.

      A randomized controlled clinical trial will be performed. First a pilot study will be carried
      out. Patients with carpal tunnel syndrome included on waiting surgery list of Miguel Servet
      Hospital will be recruited. They will be randomized into a control group (staying in waiting
      list and performing healthcare standard) and into an experimental group (3 sessions of 45 min
      of diacutaneous fibrolysis and homebased treatment). Different outcomes will be assessed at
      pre-treatment, at the end of treatment, 3 and 6 months later.
    


Intervention name(s): Multimodal conservative treatment
Intervention type(s): Other
Intervention description(s): 15 min of Pain education + 20 min of Specific mobilization of the forearm musculature, pronator teres, tendons of the palmar flexors of the wrist and fingers, transverse carpal ligament and palmar fascia through manual mobilization assisted by Diacutaneous Fibrolysis technique + 10min of self-management and explanation of home-based exercise.
3 sessions of 45 minutes will be taken to perform this protocol and the patient will be shown a self-treatment to be performed 3-5 times a day. The protocol will be carried out over 3 weeks (1 session per week).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Food on the Pharmacokinetics of ASTX660 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-dose, open-label, randomized, three-period, three-way crossover
      study in which healthy adult participants will receive three separate single-dose
      administrations of ASTX660 capsules under three different conditions.
    

Detailed description: 
      Participants receiving Treatment A (fasting) will be dosed after having fasted overnight for
      at least 10 hours. Participants receiving Treatment B (fed; high-fat/high-calorie meal) will
      fast overnight for at least 10 hours then consume a Food and Drug Administration (FDA)
      standard high-fat, high-calorie breakfast beginning 30 minutes before dosing. Participants
      receiving Treatment C (fed; low-fat/low-calorie meal) will fast overnight for at least 10
      hours then consume an FDA standard low-fat, low-calorie breakfast beginning 30 minutes before
      dosing. The duration of the study is expected to be approximately 47 days.
    

Intervention name(s): ASTX660
Intervention type(s): Drug
Intervention description(s): Form: capsule; Route of administration: oral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Skin Tolerance Study of Betamethasone Creams in Atopic Eczema and the Preventative Properties of a Moisturiser
Condition: Atopic Eczema
MeSH terms: Dermatitis, Atopic; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      Topical steroid creams as well as moisturizing creams are important parts of the treatment
      strategy of atopic eczema. This study aims to investigate the tolerance of a new strong
      steroid cream in comparison to an already marketed reference cream with equal amount of
      active but with different cream vehicle. The second part of the study will investigate the
      possible preventative property of a moisturizing cream on skin that has been previously
      cleared from eczema.
    


Intervention name(s): betamethasone valerate; betamethasone valerate; urea
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Topical application according to a fixed schedule for three weeks; Topical application according to a fixed schedule for three weeks; Topical application twice daily for up to 6 months
Other intervention name(s): Betnoderm 0,1 % kräm; Betnovat kräm 0,1%; Canoderm kräm 5%
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atopic eczema; Topical corticosteroid
Renal Effect of Stribild or Other Tenofovir DF-containing Regimens Compared to Ritonavir-boosted Atazanavir Plus Abacavir/Lamivudine in Antiretroviral Treatment-naive HIV-1 Infected Adults
Condition: HIV-1 Infection
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to assess glomerular function before and during
      administration of stribild (STB; elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil
      fumarate (E/C/F/TDF)) or a regimen containing TDF without cobicistat (COBI) as ritonavir
      (RTV)-boosted atazanavir (ATV/r) plus truvada (TVD; FTC/TDF) or atripla (ATR;
      efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF)) compared to a regimen
      containing neither TDF nor COBI as ATV/r plus abacavir/lamivudine (ABC/3TC) via determination
      of actual glomerular filtration rate (aGFR) using iohexol (a probe GFR marker) plasma
      clearance and estimated (calculated) glomerular filtration rate (eGFR).
    


Intervention name(s): STB; TVD; ATR; RTV; ATV; ABC/3TC; Iohexol
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 150/150/200/300 mg fixed dose combination (FDC) tablet administered orally once daily with food; 200/300 mg FDC tablet administered orally once daily with food; 600/200/300 mg FDC tablet administered orally once daily on an empty stomach at bedtime; 100 mg tablet administered orally once daily with food; 300 mg capsule administered orally once daily with food; 600/300 mg FDC tablet administered orally once daily with food; 1500 mg solution administered intravenously at baseline, and at Weeks 4, 8, 16, and 24
Other intervention name(s): Stribild®; Truvada®; Atripla®; Norvir®; Reyataz®; Kivexa®; Omnipaque™
Intervention MeSH terms: Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Deworming and Vitamin A (DEVTA) Prepilot Study
Condition: Malnutrition; Worm Infestation; Under-Fives
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 3

Summary: 
      Background. More than a third of the world's population is infected with intestinal
      nematodes. A majority of these infections occur in children. Current control approaches
      emphasise treatment of school age children, and there is a lack of information on the effects
      of deworming preschool childrenSetting: Within the Integrated Child Development System (ICDS)
      infrastructure in urban Lucknow (UP), IndiaDesign: Open Labeled randomised trialHypothesis:
      Our study hypothesis was that albendazole administration six monthly, as a single 400 mg dose
      in syrup, by the existing health care delivery system would be a practicable way to achieve
      mass deworming of preschool children and this might result in an improvement in weight gain
      of preschool childrenIntervention One group will receive usual health care by the existing
      health care staff, which included six monthly administration of Vitamin A concentrate. The
      other group will receive, in addition, 400 mg of albendazole (Zentel, Smith Kline & Beecham)
      in 10 ml syrup form. Five such doses will be given at six monthly intervals for 2 years.Main
      objective: To assess the impact of 6 monthly deworming on weight and height gain at the end
      of 2 years in children aged 1 to 5 years of age Main outcomes measures: Weight gain in 2
      yearsInclusion criteria: Children 1 to 5 years, whose guardians give written informed
      consent. Exclusion criteria: Those not consentingSample size: Sample size was calculated for
      a continuous outcome. For a standardized effect size of 0.1, with a power of 80% and an alpha
      level of 0.05, using a 2-tailed t test, taking into account design effect, about 2000
      children will be included in each arm.
    


Intervention name(s): Albendazole (400 mg) and/or Vitamin a
Intervention type(s): Drug
Intervention MeSH terms: Vitamin A; Albendazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Deworming; Malnutrition; children; Community; India
Giardia Induced Fatigue and Functional Gastrointestinal Diseases
Condition: Chronic Fatigue Syndrome
MeSH terms: Fatigue Syndrome, Chronic; Syndrome; Fatigue
Study type: Interventional
Phase: Phase 4

Summary: 
      A giardiasis outbreak in Bergen has given us the opportunity to approach two basic research
      questions of national and global importance:

        -  Studying the pathoimmunology of giardiasis in a natural setting, and following the
           genetic and immunological responses leading to recovery or persistent disease and
           sequelae.

        -  Studying the two disease entities FGID and CFS when induced by acute giardiasi and their
           risk factors.

        -  Interventional cognitive behavioural therapy is the only intervention documented to have
           significant effect on CFS outcome, and conventional cognitive behavioural therapy will
           be compared to a psycho-educational programme in the format of a randomised controlled
           trial.
    


Intervention name(s): Psycoeducation/counseling; Cognitive behavioural therapy
Intervention type(s): Other; Behavioral
Intervention description(s): 2 days of education on mechanisms of illness and coping strategies; 4 days intensive training in understanding and behavioural changes
Other intervention name(s): CBT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CFS; Giardia; Fatigue; Cognitive behavioural therapy; CBT; Chronic fatigue syndrome
Respiratory Muscle Training in Hemodialysis Patients
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Study type: Interventional

Summary: 
      The research protocol is a Randomized Clinical Trial that has the effectiveness of a given
      respiratory muscle training protocol over the indicative variables: Pulmonary function;
      Markers of oxidative stress and inflammation, endothelial markers and Quality of life in
      patients with chronic kidney disease undergoing hemodialysis. According to the Investigators,
      this topic was proposed since it is known that several pulmonary complications occur as a
      consequence of chronic kidney disease due to uremic myopathy. Therefore, the hypothesis is
      that the application of a respiratory muscle training protocol will contribute positively
      pulmonary functionality and a decrease in oxidative stress and inflammation in chronic kidney
      patients, consequently, will bring improvement in the quality of life for these patients. The
      Patients will be divided into two groups: control group - No intervention of the Muscular
      Training (CG) And Intervention Group (GI). The intervention protocol will be composed of
      respiratory muscle training And lasts for two (2) months, with three (3) visits per week. It
      will be carried out through Threshold PeP appliance. The twelve (12) first training sessions
      will have a total duration of 30 minutes 15 minutes with inspiratory load of 20 cmH2O and 15
      minutes with expiratory load of 20 CmH 2 O; and the others (12) twelve sessions will last 40
      minutes each, with 20 minutes with an inspiratory load of 20 CmH2O and 20 minutes with
      expiratory load of 20 cmH2O. The variables evaluated will be: muscular strength Respiratory
      (maximum inspiratory pressure and maximum expiratory pressure - Pimáx and Pemáx); Lung
      function (Slow Vital Capacity - CVL, forced expiratory volume in the first minute - VEF1,
      Vital Capacity Forced - CVF and Maximum Voluntary Ventilation - VVM); Serum levels of
      oxidative stress markers, endothelial markers and endothelin.
    


Intervention name(s): Muscle respiratory training
Intervention type(s): Behavioral
Intervention description(s): Muscle respiratory training during hemodialysis sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Effect of Menstrual Cycle Phase and a Protein-polyphenol Drink on Muscle Protein Synthesis
Condition: Muscle Protein Synthesis
Study type: Interventional

Summary: 
      Amino acid (building blocks of protein) and polyphenol supplements are commonly consumed post
      resistance exercise in order to aid muscle recovery. Both supplements have been shown to be
      beneficial in isolation, however, there is little known about the effect on recovery of
      combining the two.

      Muscle recovery is related to the ability to build new muscle protein from amino acids
      (muscle protein synthesis). This response is thought to be impacted in females by hormones
      that fluctuate across different phases of the menstrual cycle. However, the effect of
      menstrual cycle phase on muscle protein synthesis during recovery is not known.
    


Intervention name(s): Bolus ingestion of protein; a blend of protein and polyphenol
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Different phases of the menstrual cycle; a blend of protein and polyphenol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science