bioihbjkbjnl/mcl2 huggingface dataset:
Connective Tissue Manipulation and Combined Ultrasound Therapy in Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Observational

Summary: 
      The aim of this study was to evaluate the short term and one year follow-up results of
      connective tissue manipulation and combined ultrasound therapy (ultrasound and high voltage
      pulsed galvanic stimulation) in terms of pain, complaint of non-restorative sleep and impact
      on the functional activities in patients with fibromyalgia.
    

Detailed description: 
      This is an observational prospective cohort study, investigating short and long term results
      of physiotherapy applications in 20 female patients with fibromyalgia. Physical
      characteristics of the subjects were recorded. Intensity of pain, complaint of
      non-restorative sleep, and impact of fibromyalgia on functional activities were evaluated by
      visual analogue scales. All evaluations were performed before and after 20 sessions of
      treatment, which included connective tissue manipulation of the back daily, for a total of 20
      sessions and combined ultrasound therapy of the upper back region every other session. One
      year follow-up evaluations could be performed on 14 subjects.
    

Intervention name(s): combined ultrasound therapy; connective tissue manipulation
Intervention type(s): Device; Procedure
Observational model: Defined Population
Time perspective: Prospective
Keywords: fibromyalgia; connective tissue manipulation; ultrasound therapy; high voltage pulsed galvanic stimulation
Study of Cilostazol and Probucol to Assess Their Effects on Atherosclerosis Related Biomarker
Condition: Type 2 Diabetes Mellitus; Arteriosclerosis Obliterans
MeSH terms: Atherosclerosis; Arteriosclerosis; Arteriosclerosis Obliterans; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      1. To evaluate the efficacy of Cilostazol and Probucol alone and in combination on
           atherosclerosis related biomarker

        2. To evaluate the safety of Cilostazol and Probucol alone and in combination on
           atherosclerosis related biomarker
    

Detailed description: 
      Efficacy evaluation:

      Primary efficacy index:

      After 12 weeks of treatment, the change of arteriosclerosis related biomarker in 4 modality
      groups, comparing with the base line information

      Secondary efficacy index:

      After 8 weeks of treatment, the change of arteriosclerosis related biomarker in 4 modality
      groups, comparing with the base line information

      Safety evaluation:

        1. Adverse Event

        2. Vital Sign and Physical Examination

        3. 12-lead ECG

        4. Laboratory Tests (including blood routine examination, routine urine analysis, blood
           biochemistry examination, glycosylated hemoglobin)
    

Intervention name(s): Cilostazol; Probucol; Cilostazol+Probucol; Control Group
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): From 50mg, Bid, PO after breakfast and dinner. After 1-week of administration, if no significant study drug related discomfort, the dose can increase to 100mg, Bid, PO. Otherwise, remain at the 50 mg level.; 250 mg Bid, PO after breakfast and dinner.; Routine treatment
Other intervention name(s): pletaal; Changtai; Pletaal and Changtai; Routine treatment
Intervention MeSH terms: Cilostazol; Probucol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 2 diabetes mellitus, with Arteriosclerosis obliterans
Walk-Training Program for Individuals With Chronic Spinal Cord Injury (SCI)
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      Cardiovascular disease (CVD) is the common leading cause of death among people with spinal
      cord injury (SCI) and occurs at an early age in people with SCI as compared to able-bodied
      people. The findings are consistent in demonstrating a high prevalence of CVD among people
      with SCI. Lack of physical activity and/or prolonged sitting which is observed in people with
      SCI due to impaired/loss of motor function is associated with increased risk factors of CVD.
      By doing this study, researchers hope to learn the effects of walking training on
      cardiovascular health among people with chronic SCI.
    


Intervention name(s): walking training
Intervention type(s): Behavioral
Intervention description(s): Participants will receive three sessions a week of BWSTT with assistive training device for 8 weeks; a total of 24 sessions. The duration of each training session will an hour. During walk-training, the participant will wear a harness which is attached to an overhead motorized lift to provide body-weight support and to prevent the risk of falling.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiovascular health; Walking training
Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection
Condition: Ovarian Epithelial Cancer Recurrent
MeSH terms: Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 1

Summary: 
      Bioequivalence study is proposed to be carried out on patients of ovarian cancer, who are
      already receiving or who in the opinion of their treating physicians are candidates for
      Doxorubicin liposomal injection therapy .
    

Detailed description: 
      This study has sequential two stage design. Bioequivalence based on encapsulated doxorubicin
      will be tested at the end of stage 1. Power analysis will be performed for the primary
      pharmacokinetic parameters of free Doxorubicin and liposome encapsulated Doxorubicin, for all
      completed patients before bioequivalence evaluation. If observed power will be >= 80% then
      two one-sided 90% CI will be calculated for bioequivalence assessment at stage I.

      If observed power will be < 80% then bioequivalence will be evaluated at stage I. If
      bioequivalence met then study will be stopped and if bioequivalence not met, then required
      additional patients will be enrolled in stage II.

      Each patient will be randomized to one of the two treatment sequences ( RT or TR ) according
      to a randomization scheme prepared prior to the start of the trial. Serial blood samples for
      determination of free doxorubicin and liposomal encapsulated doxorubicin plasma concentration
      for PK analysis will be obtained in each cycle .

      Bioequivalence Criteria : The 94.12% confidence intervals for the ratio of geometric least
      squares means of ln-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf should
      be within 80.00 to125.00% to conclude the test product is bioequivalent to the reference
      product.
    

Intervention name(s): Doxorubicin Hydrochloride Liposome Injection
Intervention type(s): Drug
Intervention description(s): 50mg/m2, IV on Day 1 of each cycle, On Day 1 of Cycle 2 , patients will crossover to the alternate reference or test formulation , After completion of Cycle 2 ( Day 28) , patients will be continued on the treatment of Doxorubicin Hydrochloride Liposome injection upto 4 more cycles if tolerance permits under guidance of their attending physicians.
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Serum Galectin-3 as a Marker of Human Papillomavirus Infection
Condition: Human Papillomavirus Infection
MeSH terms: Infections; Communicable Diseases; Papillomavirus Infections
Study type: Observational

Summary: 
      This study aimed to assess the serum Galectin-3 levels in patients with warts both before and
      after cryotherapy and to investigate its potential contribution to the pathogenesis of human
      papillomavirus infection.
    

Detailed description: 
      Galectin-3 regulates many functions at the cellular level such as cell attachment,
      proliferation, and apoptosis. Numerous viral illnesses, including human papillomavirus
      infection, were reported to have elevated serum levels of Galectin-3. .

      Methods: Fifty patients suffering from warts, and fifty healthy controls were included in
      this study. Enzyme-linked immunosorbent assay was used to measure serum levels of Galectin-3
      both before and 2 weeks after the last cryotherapy session.
    

Intervention name(s): cryotherapy; serum Galectin-3 assay
Intervention type(s): Procedure; Diagnostic Test
Intervention description(s): Every patient had a cryotherapy session every 2 weeks until complete clearance for a maximum of six sessions and follow-up was done at 3 months after treatment completion to detect any recurrence. Each wart was frozen using the spray technique by CRY-AC Liquid Nitrogen Dispenser Brymill, USA for 10 to 30 seconds until a 1- to 2-mm ice ball halo was formed surrounding the targeted area.; From each patient and control, 3 ml venous blood was withdrawn under complete aseptic conditions before treatment and 2 weeks after the last treatment session by a disposable plastic syringe; the collected blood was placed on a plain tube without anticoagulant for 30 min at room temperature till coagulation occurs; after this, centrifugation of tubes was done for 20 min at 1000 rpm. The serum was separated into an aliquot and placed at -20 degrees Celsius for further analysis. Serum Gal-3 was measured using human Galectin-3 enzyme-linked immunosorbent assay (ELISA) kits supplied by ELK Biotechnology CO., LTD, Wuhan, China, catalog number (ELK2790) based on the Sandwich-ELISA technique as per the manufacturer's instructions.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This case-control study was performed on 50 patients with any type of cutaneous warts
        except for genital warts and 50 apparently healthy age-and sex-matched control subjects
        without a history of warts attending the Outpatient Clinic of Dermatology, Venereology and
        Andrology Department of Assiut University Hospitals.
      
Keywords: Galectin-3; Human papillomavirus; Warts; Cryotherapy
Treatment of Uncomplicated Malaria in Benin
Condition: Uncomplicated Malaria
MeSH terms: Malaria
Study type: Interventional

Summary: 
      Malaria is a life-threatening disease especially in small children. A high degree of
      Plasmodium falciparum resistance to chloroquine has already spread to South-Benin where this
      study is taking place. In the past few years, the recommendation for a first-line treatment
      in this area has moved from chloroquine to sulfadoxine-pyrimethamine (SP). There is growing
      evidence that Plasmodium falciparum resistance to SP has come to South-Benin. The aim of the
      study is to compare the efficacy of SP to two compact artemisinin-based therapies (ACT):
      artemether-lumefantrine and the amodiaquine-artesunate coformulation. ACT will be
      unsupervised.

      The primary endpoint is an effectiveness comparison (PCR corrected) at day 28. Secondary
      outcomes are effectiveness comparisons (PCR corrected) at day 14 and 42 and a study on the
      relationships between ACT PK data (day 3) and outcome.

      Expected total enrollment: 225 patients

      Study start: April 2007; expected completion: December 2007
    


Intervention name(s): sulfadoxine-pyrimethamine; artemether-lumefantrine; amodiaquine-artesunate coformulation
Intervention type(s): Drug; Drug; Drug
Intervention description(s): tablets 1,25/25 mg
1 tablet per 20 kg of body weight Single drug intake; tablets 20/120 mg
1 tablet twice daily for 3 days below 15 kg of bodyweight
2 tablets twice daily for 3 days below 24 kg of bodyweight
3 tablets twice daily for 3 days below 35 kg of bodyweight; one 25mg/67,5mg tablet, once daily for 3 days below 9 kg
one 50/135mg tablet, once daily for 3 days below 18 kg
Other intervention name(s): Fansidar; coartem; coarsucam
Intervention MeSH terms: Artesunate; Lumefantrine; Pyrimethamine; Artemether; Sulfadoxine; Artemether, Lumefantrine Drug Combination; Fanasil, pyrimethamine drug combination; Amodiaquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: uncomplicated malaria; children; treatment; effectiveness
A Single-Center, Open-Label, Study of the Plasma Pharmacokinetics and Safety of AC-170 0.24%
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the Plasma Pharmacokinetics and Safety of AC 170
      0.24% in Healthy, Adult Subjects when used twice daily for one week.
    


Intervention name(s): AC 170 0.24%
Intervention type(s): Drug
Intervention description(s): 1 drop in each eye 2 times daily for 1 week
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Open Label Study of Long Term Treatment of Pediatric Treatment of Atopic Dermatitis With Pimecrolimus Cream 1% Within a Usual Clinical Setting
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      An open-label, multicenter study, of long term management to evaluate effectiveness,
      tolerability and safety of pimecrolimus cream 1% in pediatric patients with mild to moderate
      atopic dermatitis in a daily practice
    


Intervention name(s): Pimecrolimus
Intervention type(s): Drug
Intervention description(s): Pimecrolimus cream 1 %
Other intervention name(s): Elidel
Intervention MeSH terms: Pimecrolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atopic dermatitis, pimecrolimus, children
Epigenetics and Psychoneurologic Symptoms in Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      This study examines the relationship among epigenetic alterations and the development and
      persistence of psychoneurologic symptoms (cognitive dysfunction, depressive symptoms,
      anxiety, fatigue, sleep disturbance, and pain) in women receiving chemotherapy for early
      stage breast cancer. The relationship among inflammatory markers and psychoneurologic
      symptoms will also be explored. It is hypothesized:

        1. Chemotherapy triggers inflammatory activation, which in turn leads to the acquisition of
           genetic alterations. These alterations result in cellular changes and are modified over
           time.

        2. Inflammatory activation and epigenetic alterations are related to the temporal
           development, severity, and persistence of psychoneurologic symptoms.
    

Detailed description: 
      Advancements in breast cancer have resulted in increased survival rates; however, many women
      with breast cancer experience distressing symptoms. Inflammatory activation and epigenetic
      alterations have been associated with the etiology of cancer. To date, no investigators have
      considered these epigenetic processes as possible mechanisms associated with the etiology of
      distressing symptoms in women with breast cancer. The specific aims of this study are to
      examine:

        1. The frequency and severity of psychoneurological (PN) symptoms (depressive symptoms,
           anxiety, sleep disturbances, fatigue, pain and cognitive dysfunction)and the
           interrelationship among PN symptoms at each time point

        2. Levels of inflammation and to quantify the frequency and genome-wide location of changes
           in epigenetic patterns across time following chemotherapy

        3. The relationship among inflammation, epigenetic changes, and the development, severity,
           and persistence of PN symptoms across time The study results may potentially deepen
           understanding regarding the biological processes underlying PN symptoms and lead to
           improved strategies for symptom management in women with breast cancer.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be recruited from oncology treatment clinics
      
Biospecimen description: 
      This study will be examining cytokine and c-reactive protein levels, DNA methylation, DNA
      repair proteins, telomere length and chromosomal instability.
    
Keywords: Epigenetics; Inflammatory; Psychoneurologic Symptoms; Cognitive Dysfunction; Pain; Fatigue; Sleep Disturbance; Depression; Depressive Symptoms; Anxiety; Breast Cancer
Occupational Therapy Home Programs in Children With Down Syndrome
Condition: Down Syndrome; Occupational Therapy; Feeding Problem
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      Children with Down Syndrome frequently encounter difficulties with sensory functions and
      feeding, such as oral sensory processing issues and developmental disorders. The aim of this
      study was to examine the effects of an Occupational Therapy Home Program on the sensory
      functions and feeding issues of children with Down Syndrome.
    

Detailed description: 
      Although there are studies that investigate nutritional issues in children with Down
      syndrome, no well-structured, high-evidence, and individual-centered studies have been found.
      The literature assumes a relationship between the sensory functions and nutritional status of
      children with Down syndrome. Therefore, further studies are needed to develop intervention
      programs to prevent sensory processing and nutritional problems.

      This study aims to evaluate the effectiveness of occupational therapy home programs in
      improving sensory functions and feeding problems in children with Down syndrome. The study
      focuses on evidence-based practices to assess the impact of these programs compared to not
      providing them.

      The study will be conducted with children diagnosed with Down Syndrome who have applied to
      the Pediatrics Unit of the Department of Occupational Therapy at Hacettepe University Faculty
      of Health Sciences.

      The study comprises pre-evaluation, final evaluation, and intervention stages. Following the
      initial evaluation, an occupational therapy home intervention program will be implemented for
      the children before and after each meal, seven days a week, for eight weeks. Evaluations will
      be repeated after the eight-week period.
    

Intervention name(s): Occupational therapy home program
Intervention type(s): Other
Intervention description(s): After evaluating the children, an occupational therapy home intervention program will be developed for each child. The program will be monitored through telephone and computer interviews, as well as video, photo, and audio recordings. The interventions in this study were selected based on successful occupational therapy home programs for children with disabilities. The program consists of five steps.
Step 1 is to establish collaborative relationships with parents. Step 2 is to determine the most appropriate goals for the child and their family. Step 3 involves selecting the most suitable therapeutic activities to achieve these goals. Step 4 is to educate and support parents in performing these therapeutic activities. Finally, Step 5 involves measuring the results and providing feedback.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups. Intervention and control groups.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Down Syndrome; Occupational Therapy; Home Program; Sensory Function; Randomized; Control Trial
Evaluation of the Performance of Monthly Replacement Sphere Lens Designs in Habitual Soft Contact Lens Wearers
Condition: Myopia; Hyperopia
MeSH terms: Hyperopia
Study type: Interventional

Summary: 
      The objective of the study is to evaluate the clinical performance of two monthly silicone
      hydrogel contact lenses in habitual wearers of frequent replacement (FRP) lenses when worn
      for one month.
    

Detailed description: 
      This study is a prospective, bilateral eye, double-masked, randomized, 1-month cross-over,
      daily-wear design involving two different FRP lens types. Each lens type will be worn for
      approximately one month.
    

Intervention name(s): Lens A (comfilcon A lens); Lens B (lehfilcon A lens)
Intervention type(s): Device; Device
Intervention description(s): 1 month; 1 month
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Insulin Resistance in Atopic Dermatitis Patients
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Insulin Resistance
Study type: Observational

Summary: 
      The aim of the study is to determine the relationship between insulin resistance and disease
      duration and severity of atopic dermatitis.
    

Detailed description: 
      The aim of the study is to determine the relationship between insulin resistance and disease
      duration and severity of atopic dermatitis. EASI and SCORAD values and disease duration of
      atopic dermatitis patients are calculated during the examination. HOMA-IR blood test result
      is compared with the results.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Atopic dermatitis patients confirmed by a dermatologist
      
Keywords: atopic dermatitis; insulin resistance
Evaluation of the Exoskeleton ATLAS 2030 as Robot-assisted Physical Therapy to Children With Neuromuscular Diseases
Condition: Cerebral Palsy; SMA II; Neuromuscular Diseases
MeSH terms: Cerebral Palsy; Neuromuscular Diseases
Study type: Interventional

Summary: 
      This study aims to evaluate the safety, usability and acceptability of a motorized mobility
      assistance exoskeleton. The protocol explores the use of the motorized device during static
      and dynamic rehabilitation sessions focused on walking and functional activities, with the
      expectation of evaluating the safety and usability of the device in the population studied.
      The protocol has been focused on defining how the device can be used appropriately in this
      population in a safe and effective manner by rehabilitation specialists. The study also aims
      to assess the safety of clinical staff who implement the intervention.
    


Intervention name(s): Exoskeleton rehabilitation
Intervention type(s): Device
Intervention description(s): The participants will perform physical therapy with the ATLSA2030 device, for 90 minutes per session.
Other intervention name(s): ATLAS2030; ATLAS; robot-assisted therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Exoskeleton; robot-assisted; physical therapy; ATLAS
Depakote ER Plus an Atypical Antipsychotic Vs. an Atypical Antipsychotic Alone in the Treatment of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the 14-day and 12-week safety and efficacy of Depakote
      ER used in combination with either olanzapine or risperidone versus antipsychotic monotherapy
      with olanzapine or risperidone for the treatment of schizophrenia.
    


Intervention name(s): Divalproex Sodium Extended-Release Tablets; Olanzapine; Risperidone
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Valproic Acid; Olanzapine; Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment