bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Cognitive Rehabilitation for Amnestic Mild Cognitive Impairment
Condition: Mild Cognitive Impairment; Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      Different cognitive rehabilitation intervention methods have been developed for the treatment
      of cognitive dysfunctions seen in mild cognitive impairment (MCI). The aim of this study was
      to examine the effectiveness of cognitive rehabilitation intervention applied with the
      telerehabilitation method in elderly patients with amnestic-MCI.

      Participants included in the study according to inclusion and exclusion criteria were
      randomly assigned to the telerehabilitation and face-to-face groups. A 12-week cognitive
      rehabilitation intervention was applied to both groups. Pre- and post-intervention cognitive
      skills of the participants were evaluated using the Loewenstein Occupational Therapy
      Cognitive Assessment-Geriatric (LOTCA-G).
    

Detailed description: 
      A single-blinded, feasibility randomized controlled trial (RCT) investigated changes in the
      cognitive functions of older adults with amnestic-MCI after CR interventions applied
      face-to-face and with telerehabilitation. The study was designed according to the CONSORT
      statement. Approval for the study was granted by the Local Ethics Committee. Written informed
      consent was obtained from all participants prior to the study.

      The demographic characteristics of the participants were recorded, including age, sex,
      education level, and marital status. All participants underwent a cognitive function
      assessment using the Loewenstein Occupational Therapy Cognitive Assessment-Geriatric twice,
      once before the intervention and again after the 12-week intervention. All participants were
      assessed in occupational therapy clinical practice units.

      Participants were randomized to either the Face-to-Face group (FF) or the Tele-rehabilitation
      group (TR) using a computer-generated randomization technique.

      After the randomization, cognitive rehabilitation intervention for both methods consist of
      45-minute twice a week for 12 weeks. All participants received the intervention individually.
    

Intervention name(s): 1-face-to-face; 2-tele rehabilitation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The cognitive rehabilitation intervention consists of 45-minute sessions, 2 days a week for 12 weeks. The same rehabilitation intervention program was applied to both groups by face-to-face or tele-rehabilitation method. The main purpose of the study is to see the effectiveness of cognitive rehabilitation intervention in the elderly with amnestic mild cognitive impairment and to compare the two methods.; 2-tele rehabilitation
Other intervention name(s): Cognitive rehabilitation; Cognitive rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single blind randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
Condition: Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
    

Detailed description: 
      A Phase 2a, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Study
      To Evaluate Safety, Tolerability, And Pharmacodynamics Of PF-05221304 Administered Daily For
      16-weeks To Adult Subjects With Nonalcoholic Fatty Liver Disease
    

Intervention name(s): Placebo; PF-05221304
Intervention type(s): Drug; Drug
Intervention description(s): Placebo; PF-05221304, Experimental Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: C1171002 is a randomized, double blind, placebo controlled, 5 arm (placebo, plus 4 active doses of PF 05221304), parallel group study.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PF-05221304; NAFLD; NASH; features of metabolic syndrome; Dose-Ranging Study
Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Pain Associated With Diabetic Neuropathy
Condition: Painful Diabetic Neuropathy; Diabetic Neuropathy; Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine whether clonidine gel is an effective treatment for
      reducing the pain associated with painful diabetic neuropathy.
    

Detailed description: 
      Study CLO 290 was a multicenter, randomized, double blind, placebo controlled, 2 arm parallel
      group study of Clonidine Gel in the treatment of pain associated with PDN. Subjects were
      randomly assigned in a 1:1 ratio to receive 1 of 2 treatments applied topically TID to both
      feet for 85 days: Clonidine Gel (3.9 mg of clonidine HCl total daily dose), or Placebo Gel
      (vehicle without clonidine). Approximately 140 adult subjects with symmetrical distal PDN
      were expected to be randomized into the study. However, a pre-planned fully blinded interim
      analysis was performed when 70 subjects had completed the study for the purpose of re
      estimating sample size. Following the recommendation of the independent, third party
      statistician who conducted the interim analysis, the sample size was adjusted to allow
      approximately 260 subjects to be randomized into the study.

      The study included 5 phases: Screening Phase (up to 21 days duration), Baseline Phase (Day 14
      to Day 8), Placebo Lead in Phase (Day -7 to Day 1), Double blind Treatment Phase (85 days),
      and a Post-treatment Follow up Phase (7 days, only for subjects not enrolling in the open
      label long term safety study, CLO 311).
    

Intervention name(s): Clonidine Gel 0.1%; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Clonidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Pain; Foot pain; Neuropathy
Gastric Swab for Helicobacter Pylori Detection
Condition: Helicobacter Pylori Infection
Study type: Interventional

Summary: 
      A randomized controlled trial for comparing the Helicobacter pylori test using the swap
      method and the method using the conventional biopsy.
    

Detailed description: 
      The aim of this study is to conduct a prospective study under the hypothesis that a cotton
      swab method in the rapid urease test is not inferior to the conventional biopsy.
    

Intervention name(s): swab RUT
Intervention type(s): Diagnostic Test
Intervention description(s): rapid urease test using swab instead of biopsied tissue
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Diagnostic
Keywords: Helicobacter Pylori; rapid urease test; swab
CKD-397 Drug-drug Interaction Study (A)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate to effect of tamsulosin on the pharmacokinetic
      properties of tadalafil
    

Detailed description: 
      This study is a randomized, open-label, mutiple dosing, 2-way crossover design to evaluate
      the pharmacokinetic effect of tamsulosin(0.2mg) on tadalafil(5mg) in healthy male subjects.
      Subjects will receive repeated dose of tadalafil (5mg*1t/day) or tadalafil (5mg*1t/day) /
      tamsulosin (0.2mg*1t/day) for 5days. Each treatment period was separated by a washout period
      of at least 10 days.

      Each period of study will enroll 8 healthy male subjects. Blood samples for pharmacokinetic
      analysis will be taken at regular intervals after dosing. Safety will be assessed by
      measurement of blood pressure, heart rate, safety laboratory data, and review of adverse
      events.
    

Intervention name(s): Cialis Tab. 5mg; Harnal-D Cap. 0.2mg
Intervention type(s): Drug; Drug
Other intervention name(s): Tadalafil 5mg; Tamsulosin 0.2mg
Intervention MeSH terms: Tadalafil; Tamsulosin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Male; Volunteers
Vascular Endothelial Factor Gene Polymorphism in Preeclampsia
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Observational

Summary: 
      In this study, the investigators assessed one of the released protein factors during the
      pathophysiology of preeclampsia. They evaluated vascular endothelial growth factor gene
      mutation which affects the angiogenesis in case of inadequate placentation and its
      association with Doppler changes in the pulsatility index of the umbilical artery.
    

Detailed description: 
      Preeclampsia is a syndrome characterized by occurrence of hypertension and proteinuria after
      20 weeks of gestation. The pathophysiology of preeclampsia involves abnormalities in the
      development of placental vasculature early in pregnancy may result in relative placental
      under perfusion/hypoxia/ischemia, which then leads to release of factors into the maternal
      circulation that alter maternal endothelial function and cause hypertension and other
      manifestations of disease .Vascular endothelial growth factor (VEGF) is a signal protein
      produced by cells that stimulates vasculogenesis and angiogenesis. It is part of the system
      that restores the oxygen supply to tissues when blood circulation is inadequate. Human VEGF
      gene is located on chromosome 6 and consists of 8 exons with alternate splicing, forming a
      family of proteins. There are several common single nucleotide polymorphisms (SNPs) in the
      VEGF gene, which could alter gene expression and protein production, and alter the risk of
      developing diseases characterized by deranged angiogenesis including preeclampsia.
    

Intervention name(s): PCR; Doppler ultrasound
Intervention type(s): Diagnostic Test; Device
Intervention description(s): Polymerase chain reaction was used to diagnose gene polymorphism.; Doppler ultrasound was used to assess the pulsatility index of the umbilical artery .
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        normal and preeclamptic pregnant women after 20 weeks were evaluated for VEGF gene
        polymorphism.
Effects of Three Different Mouth Rinses on Dental Plaque in Children
Condition: Gingival Diseases
MeSH terms: Dental Plaque; Gingival Diseases
Study type: Interventional

Summary: 
      Dental plaque is a major problem in the field of oral and dental health and its prevention is
      more important to avoid dental caries and gingival diseases. Mouth washes are very useful in
      the reduction of microbial plaque and gingival inflammation. Sodium fluoride mouth wash is
      one of the ways that prevent dental plaque. Recently, using herbal products are efficient in
      decreasing dental plaque. Pomegranate peels and Guava leaves extracts are an essential
      medicinal plant with various pharmacological properties.

      Aim of study: To evaluate and compare the efficiency of different mouth rinses (sodium
      fluoride mouth rinse, guava leaves aqueous extract and pomegranate aqueous extract) on dental
      plaque in children, clinically by measuring gingival and plaque indices scores and
      microbiologically by measuring of streptococcus mutans and lactobacillus.

      Materials and methods: forty apparently healthy and cooperative children were selected from
      the Outpatient Dental Clinic of Pediatric dentistry Department, Faculty of Dentistry, Suez
      Canal University. Children were randomly divided into three groups as follows:

      Group (I):10 children will rinse with sodium fluoride, Group (II): 10 children will rinse
      with guava leaves aqueous extract and Group (III):10 children will rinse with pomegranate
      peels aqueous extract. Group (IV):10 children will rinse with water (control group).
      Instructions for oral hygiene and using mouth wash will be demonstrated for every child.
      Clinical and microbiological examinations will be done firstly at day one before using any
      type of examined mouthwashes (0-base line), then clinical and microbiological follow up will
      be done after 7 and 15 days of using different mouthwash for each group.
    


Intervention name(s): sodium fluoride solution; guava leaves aqueous extract; pomegranate peel aqueous extrac; Distilled water
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): sodium fluoride solution mouth rinse (0.2%).; guava leaves aqueous extract mouth rinse (0.5%); pomegranate peel aqueous extract mouth rinse (0.5%).; placebo distilled water
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Effects of Soy Isoflavone on Bone Health Among Saudi Female Students Imam Abdulrahman Bin Faisal University.
Condition: Soy Isoflavone Effect; Bone Density, Low; Bone Density Increased
MeSH terms: Bone Diseases, Metabolic; Osteosclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Low bone mineral density (BMD) has recently increased among young women. Soy Isoflavone as a
      food supplement, has been found to have potent effect on bone health in postmenopausal women.
      However, the effect of soy isoflavone on pre-menopausal is not well understood. This research
      is done to examine the effect of soy isoflavones on BMD among young university female
      students.
    


Intervention name(s): Soy Isoflavone supplement
Intervention type(s): Dietary Supplement
Intervention description(s): Participants received 60 mg of soy-isoflavone supplement per day.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Pre-post Quasi experimental study design.
Masking: None (Open Label)
Primary purpose: Prevention
Exercise Following Bariatric Surgery for Severe/Morbid Obesity (EFIBAR)
Condition: Obesity, Morbid; Bariatric Surgery Candidate
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      Severe/morbid obesity is an international public health issue that importantly increases the
      risk of cardiovascular events and cardiovascular and all-cause mortality. Likewise,
      severe/morbid obesity increases the risk of illness, reduces quality of life, and raises
      health-care costs. Bariatric surgery is the election method for the treatment of
      severe/morbid obesity, resulting in significant weight loss and remission of comorbidities.
      However, a relatively large proportion of bariatric patients regain weight and continue to be
      at high risk for cardiovascular disease and premature mortality. A healthy lifestyle
      following bariatric surgery is essential for optimizing and maintaining weight loss.
      Observational studies suggest that physical activity following bariatric surgery might be
      associated with additional weight loss and more effective weigh loss maintenance over time.
      However, very little experimental evidence exists regarding the effects of supervised
      exercise on obesity-related outcomes in this specific population.

      The aim of the EFIBAR (Ejercicio FÍsico tras cirugía BARiátrica) randomized controlled trial
      is to determine the effects of a 16-week supervised concurrent (aerobic and strength)
      exercise intervention program, on weight loss (primary outcome), body composition,
      cardiometabolic risk, physical fitness and quality of life (secondary outcomes) in patients
      with severe/morbid obesity following bariatric surgery.

      According to the study aims the investigators pursue the following hypothesis: Supervised
      exercise will result in larger weight loss than control.
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Concurrent (aerobic and strength) supervised exercise program: the program comprises 3 sessions/week (60 min/session) of aerobic and strength exercises of progressive volume and intensity. The program will follow the Consensus on Exercise Reporting Template (CERT) guidelines.
Other intervention name(s): Exercise training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible participants will be randomly assigned (1:1) sequentially, as they will be submitted to bariatric surgery, to one of the two following groups:
CON - Usual care (following international guidelines) after bariatric surgery. EX - Usual care plus supervised exercise program.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Morbid obesity; Exercise; Weight loss; Cardiometabolic risk; Bariatric surgery
Bioavailability Study of Letrozole Tablets 2.5 mg of Dr.Reddy's Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare bioavailability in healthy, post menopausal women
      subjects under fed conditions.
    

Detailed description: 
      An Open Label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Cross-Over,
      Single-Dose, Comparative oral bioavailability study in healthy, post menopausal women
      subjects under fed conditions.
    

Intervention name(s): Letrozole
Intervention type(s): Drug
Intervention description(s): Letrozole Tablets 2.5 mg of Dr.Reddy's Laboratories Limited
Other intervention name(s): Femara® Tablets 2.5 mg
Intervention MeSH terms: Letrozole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate SPI-1005 in Adults With Meniere's Disease
Condition: Meniere's Disease
MeSH terms: Meniere Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will evaluate the safety and efficacy of three dose levels of SPI-1005 compared to
      placebo on vertigo, tinnitus and sensorineural hearing loss in 40 adults with Meniere's
      disease.
    

Detailed description: 
      Randomized, double-blind, placebo-controlled safety, pharmacokinetic, pharmacodynamic study
      of oral SPI-1005 in adults with Meniere's disease. All subjects will undergo baseline
      audiometric testing and have their severity of sensorineural hearing loss, tinnitus and
      vertigo determined before the start of a 21-day course of treatment with SPI-1005 or placebo.
      During treatment with SPI-1005, and 7 days and 28 days following the cessation of SPI-1005,
      subjects will have their hearing loss, tinnitus and vertigo assessed. Additional testing
      including electrocochleography will be performed at baseline, at the end of SPI-1005
      treatment, and 28 days after the SPI-1005 treatment has stopped. Six outpatient visits will
      be performed over a 7-week period.
    

Intervention name(s): SPI-1005
Intervention type(s): Drug
Intervention description(s): Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.
Other intervention name(s): ebselen
Intervention MeSH terms: Ebselen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Meniere's; hearing loss; vertigo; tinnitus; ebselen
Single Dose Study to Determine the Safety, Tolerability, and Pharmacokinetic Properties of Lorcaserin Hydrochloride (BELVIQ) in Obese Adolescents From 12 to 17 Years of Age
Condition: Pharmacokinetics in Obese Adolescents
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the PK properties, tolerability, and safety of
      lorcaserin HCL (BELVIQ) in obese adolescent subjects between the ages of 12 to 17 years old
    

Detailed description: 
      The purpose is to:

        1. Assess the single-dose pharmacokinetic (PK) parameters of lorcaserin and a primary
           metabolites (M1 and M5) in obese adolescent subjects ages 12-17 (inclusive)

        2. Assess the safety and tolerability of a single oral dose of lorcaserin in obese
           adolescent subjects ages 12-17 (inclusive)
    

Intervention name(s): Lorcaserin
Intervention type(s): Drug
Other intervention name(s): BELVIQ
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
99mTc-ADAPT6-based HER2 Imaging in Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The study should evaluate distribution of 99mTc- ADAPT6 in patients with primary
      HER2-positive and HER2-negative breast cancer.

      The primary objective are:

        1. To assess distribution of 99mTc- ADAPT6 in normal tissues and in tumours over time;

        2. To assess kinetics of 99mTc- ADAPT6 in blood;

        3. To evaluate dosimetry of 99mTc- ADAPT6;

        4. To obtain initial information concerning safety and tolerability of 99mTc- ADAPT6 after
           single intravenous injection:

      The secondary objective is:

      1.To compare the tumour imaging data with the concerning HER2 expression obtained by
      immunohistochemistry (IHC) or fluorescent in situ hybridisation (FISH) analysis of biopsy
      samples:
    

Detailed description: 
      Overall goal of the project: To determine HER2 expression level in primary breast cancer and
      possibly in axillary lymph node metastases before neoadjuvant trastuzumab therapy.

      Phase I. Distribution of 99mTc-ADAPT6 in patients with primary breast cancer. The study
      should evaluate distribution of 99mTc- ADAPT6 in patients with primary HER2-positive and
      HER2-negative breast cancer.

      The primary objective are:

        1. To assess distribution of 99mTc- ADAPT6 in normal tissues and in tumours over time;

        2. To assess kinetics of 99mTc- ADAPT6 in blood;

        3. To evaluate dosimetry of 99mTc- ADAPT6;

        4. To obtain initial information concerning safety and tolerability of 99mTc- ADAPT6 after
           single intravenous injection:

      The secondary objective is:

      1. To compare the tumour imaging data with the concerning HER2 expression obtained by
      immunohistochemistry (IHC) or fluorescent in situ hybridisation (FISH) analysis of biopsy
      samples:

      Methodology:

      Open-label, exploratory, single centre study. The subjects will receive a single injection of
      the labelled tracer.
    

Intervention name(s): SPECT
Intervention type(s): Diagnostic Test
Intervention description(s): One single injection of 99mTc- ADAPT6, followed by gamma camera imaging directly post-injection and after 2, 4 and 6 hours.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with primary HER2-positive and HER2-negative breast cancer.
      
Keywords: 99mTc-ADAPT6; Breast Cancer; HER2 expression