bioihbjkbjnl/mcl2 huggingface dataset:
DHA Supplementation in Patients With STGD3
Condition: Dominantly Inherited Stargardt's Disease (STGD3)
MeSH terms: Stargardt Disease
Study type: Interventional

Summary: 
      We have found that biomarkers of long-term elevated dietary intake of omega-3 fatty acids
      such as DHA and EPA are inversely associated with severity of disease phenotype in STGD3
      patients. Therefore, the purpose of this study is to follow STGD3 patients as they supplement
      their diets with DHA/EPA.
    


Intervention name(s): Over the counter DHA/EPA dietary supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): 1000 mg/day DHA/EPA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Intensive Strength Training in Children With Cerebral Palsy - Effect on Hand Function
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to gain more knowledge about the association between muscle
      weakness, spasticity and motor control in children with cerebral palsy, and its relationship
      to hand function.
    


Intervention name(s): Botulinum Toxin A; Resistance training
Intervention type(s): Drug; Behavioral
Other intervention name(s): Botox; BoNT A; Strength training
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Resistance Training and Cardiometabolic Risk
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      Little is known on the effects of resistance training (RT) alone in individuals with
      metabolically healthy obesity (MHO) and metabolically unhealthy obesity (MUHO). The present
      study aimed to examine the impact of RT on body composition, physical performance,
      lipid-lipoprotein profile, inflammation, and glucose-insulin homeostasis in 51 sedentary,
      postmenopausal women categorized as MHO vs MUHO, according to the Karelis and Rabasa- Lhoret
      classification or a single-phenotype adiposopathy approach (the plasma adiponectin (A)/leptin
      (L) ratio). Participants followed a 4-month weekly RT program of 3 non-consecutive days of 6
      exercises of major muscle groups (3 sets of 10 repetitions at 80% 1-RM).
    

Detailed description: 
      Several studies have examined MHO individuals' responses to weight loss interventions.
      Caloric restriction decreases body weight and body fat, notably visceral fat accumulation, of
      both MHO and MUHO pre- and postmenopausal women, although changes in MUHO women are usually
      more important. In addition, while insulin sensitivity of MUHO women increases after a
      12-week diet, it is significantly worsened in postmenopausal MHO women. In this regard,
      previous works have shown discordant data of interventions including physical activity on the
      cardiometabolic risk and more particularly, insulin sensitivity. Indeed, diet or aerobic
      training alone or combined aerobic and resistance training (RT), in men and postmenopausal
      women yielded promising results as insulin sensitivity increased in both MUHO and MHO
      participants, with greater changes in the MUHO groups. However, the heterogeneity of the
      population (analysis without considering sex differences) as well as the type and duration (3
      to 6 months) of different interventions make it difficult to generalize these results. As an
      example, insulin sensitivity was improved in MUHO men and women, while it remained unchanged
      in MHO participants after a 9-month intervention combining diet and exercise. Moreover, a
      14-week community-based aerobic exercise program increased participants' cardiorespiratory
      fitness and reduced the number of metabolic syndrome components of MHO men and women.
      However, to the best of our knowledge, no study has compared yet the impact of a RT program
      on MUHO and MHO individuals.
    

Intervention name(s): Resistance exercise
Intervention type(s): Other
Intervention description(s): After baseline testing, participants followed a progressive resistance training program 3 times a week for 4 months.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Quetiapine vs Haloperidol Decanoate for the Long Term Treatment of Schizophrenia and Schizoaffective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      The purpose of this research study is to determine whether a new drug for schizophrenia is
      better for the maintenance treatment than a standard drugs currently prescribed. The new
      medication is called quetiapine and it will be compared with a standard medication called
      haloperidol decanoate. The study will determine if quetiapine causes fewer problems than
      haloperidol with side effects such as stiffness and restlessness and whether it costs the VA
      more or less to treat patients with quetiapine. In addition, blood samples will be collected
      every three months to determine if certain chemicals in the blood can influence the outcome
      of the subjects' illness.
    


Intervention name(s): quetiapine; haloperidol decanoate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Haloperidol; Quetiapine Fumarate; Haloperidol decanoate
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: quetiapine; haloperidol decanoate
Skin-to-skin Contact Time and Maternal Psychology
Condition: Skin to Skin Contact
Study type: Interventional

Summary: 
      The aim of this study was to determine the effect of postpartum skin-to-skin contact time on
      fear of childbirth, birth trauma and maternal attachment.
    

Detailed description: 
      This is a single-blind, randomized controlled trial. Data were collected from 110 women who
      gave birth in the gynecology clinic of a public hospital in southern Turkey between September
      2021 and February 2022. Participants who met the inclusion criteria were informed about the
      purpose of the study and skin-to-skin contact, informed consent was obtained from those who
      agreed to participate, and the women were divided into groups according to a 1:1
      computer-based randomization program. Data were collected at the time of consent to the
      study, within the first hour after birth, 24 hours after birth, 4 weeks postpartum, and 4
      months postpartum. Collected by the first author. The CONSORT directive was followed in the
      planning, implementation and writing of the research.
    

Intervention name(s): 5 minutes skin to skin contact; 60 minutes skin to skin contact
Intervention type(s): Other; Other
Intervention description(s): Skin-to-skin contact is defined as placing a naked baby on the mother's bare stomach or breast for at least one hour immediately after birth. The women in this group received 5 minutes of skin-to-skin contact as a clinic routine.; Skin-to-skin contact is defined as placing a naked baby on the mother's bare stomach or breast for at least one hour immediately after birth. In line with the recommendation of the World Health Organization, 60 minutes of skin-to-skin contact was applied to the women in this group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Elucidation and Monitoring Postprandial Endothelial Function
Condition: Cardiovascular Disease; Endothelial Dysfunction
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The primary aim of this study is to evaluate the effect of a high fat challenge on several
      measures of endothelial function. The secondary aim of this study is to elucidate the
      mechanism of postprandial endothelial dysfunction and to identify early biomarkers
    

Detailed description: 
      Endothelial dysfunction (ED) is a hallmark for the initial stage of vascular dysfunction and
      has been associated with diet-related disorders such as cardiovascular disease. This makes
      prevention of ED an important health target. From previous studies we know that a high-fat
      (HF) meal (challenge) impairs postprandial endothelial function (EF). Current studies only
      evaluated the effect of a HF meal on Flow Mediated Dilatation (FMD), a measure of macro
      vascular EF. This methodology (FMD) however, is time consuming and large variations in
      reproducibility are reported in literature. The question remains whether other types of
      macro- and micro vascular EF measurements can be used to observe ED after a HF meal that are
      more accurate, faster and easier to perform. In addition, it is know that the postprandial
      phase results in activation of leukocytes. This activation of leukocytes is likely to
      contribute to ED, but the exact underling mechanism remains unclear.
    

Intervention name(s): high fat meal; control meal
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): milkshake containing 95g fat; milkshake comparable with a normal breakfast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: endothelium,; postprandial; microvascular; macrovascular
Spanish Validation Of Quality of Life Questionnaire (QOLIE-10) For Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Observational

Summary: 
      Validation of qolie-10, an epilepsy specific quality of life questionnaire in patients
      treated with lamotrigine or valproic acid. Comparison of quality of life of epileptic
      patients treated with lamotrigine or valproic acid. Determination and assessment of the
      comparative safety of lamotrigine or valproic acid. Assessment and comparison of body image
      perception in women treated with lamotrigine or valproic acid.
    


Intervention name(s): lamotrigine; valproic acid
Intervention type(s): Drug; Drug
Other intervention name(s): lamotrigine
Intervention MeSH terms: Lamotrigine; Anticonvulsants; Valproic Acid
Keywords: quality of life; qolie-10; epilepsy; lamotrigine; Validation of questionnaire
Effect of BIA 3-202 on the Pharmacokinetics and Pharmacodynamics of Warfarin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether multiple-dose administration of nebicapone
      affects the pharmacokinetics of warfarin.
    

Detailed description: 
      Study design and methodology:

      This was a single-centre, open-label, randomised, two-way crossover study in healthy young
      male and female volunteers. The study consisted of 2 treatment periods separated by a washout
      period of 14 days or more. In one period, subjects received nebicapone 200 mg thrice-daily
      (tid) for 9 days, and a warfarin 25 mg single-dose concomitantly with the morning dose of
      nebicapone on Day 4. In the other period, a warfarin 25 mg single-dose was administered
      alone. Warfarin pharmacokinetic and pharmacodynamic profiles were characterised following
      warfarin dosing.
    

Intervention name(s): BIA 3-202; warfarin
Intervention type(s): Drug; Drug
Intervention description(s): Nebicapone tablets 200 mg; Varfine® 5 mg (warfarin 5 mg) tablets
Other intervention name(s): Nebicapone
Intervention MeSH terms: Warfarin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nebicapone; Warfarin
Optimal Site for Rapid Urease Test in the Stomach
Condition: Helicobacter Pylori Infection
Study type: Observational

Summary: 
      The accurate diagnosis of H. pylori infection is an important step for establishing the
      strategy for gastric cancer prevention. During endoscopy, rapid urease test (RUT) is the
      first of biopsy-based H. pylori tests. Despite indirect test for H. pylori detection, RUT
      shows rapid result with good sensitivity and specificity. Several study reported that H.
      pylori density was related to positive reaction time of RUT. However, there was no study
      comparing the positive reaction times of RUT according to biopsy site, degree of gastric
      atrophy, and intestinal metaplasia.
    

Detailed description: 
      The aims of this study were to: (1) assess the positive reaction times of RUT in the body and
      antrum, (2) investigate the association between the difference of RUT results (body and
      antrum) and gastric atrophy, and intestinal metaplasia, and (3) evaluate the optimal biopsy
      site for RUT according to degree of gastric atrophy in Korean population.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The subjects who underwent an upper gastrointestinal endoscopy were enrolled in this study
        at a single, tertiary-care, academic medical center. During endoscopy, rapid urease tests
        would be performed in the body and antrum.
      
Biospecimen description: 
      Biospecimen would be obtained for urease test (commercial name: CLOtest).
Pivotal Aspiration Therapy With Adjusted Lifestyle Therapy Study
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This research study is being performed to find out if a new device, AspireAssist Aspiration
      Therapy System, can help people with obesity to lose weight without causing too many side
      effects.
    

Detailed description: 
      The Aspiration process works by "correcting" meal portions after eating by removing some of
      the food left in your stomach 20 minutes after your meal, which reduces the number of
      calories absorbed by your body. This is done through a tube placed through the abdomen into
      the stomach with a small valve attached at the surface of your skin. An aspiration system
      will attach to that valve after each major meal of the day and allow you to remove a portion
      of that meal.

      During this study you will also be provided with Lifestyle therapy which includes behavioral
      therapy, diet and physical activity education. This Lifestyle therapy will also be provided
      to the participants who do not receive the AspireAssist so that the two groups can be
      compared and the benefit of aspiration for weight loss can be determined.
    

Intervention name(s): Aspiration Therapy (AspireAssist); Lifestyle Therapy
Intervention type(s): Device; Behavioral
Intervention description(s): Use of the AspireAssist device in aspiration therapy; Lifestyle therapy is a behavioral, diet and physical activity education program
Other intervention name(s): AspireAssist Aspiration Therapy System; Lifestyle Behavioral Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; obese; weight loss
Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke
Condition: Stroke; Hemiparesis; Footdrop
MeSH terms: Stroke; Paresis; Peroneal Neuropathies
Study type: Interventional

Summary: 
      This is a small pilot randomized controlled trial which will enroll both subacute (<6 mos)
      and chronic (>6 mos) stroke survivors with ankle dorsiflexion weakness. The subjects will be
      randomized to Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) versus
      control. The primary objective of this study is to compare the effect of 6-weeks of lower
      extremity CCNMES, applied in an anti-phase application, on motor impairment and functional
      mobility to a control group.
    


Intervention name(s): Contralaterally Controlled Neuromuscular Electrical Stimulation; Cyclic Neuromuscular Electrical Stimulation
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; hemiplegia; footdrop; electrical stimulation
Nimotuzumab in Combination With Chemoradiation for Esophageal Cancer
Condition: Advanced Esophageal
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located
      in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical
      efficacy has been shown in adult with head and neck cancer. The phase I study assessed the
      safety, and efficacy of the combination of Nimotuzumab administered concomitantly with
      chemo-radiotherapy in patients with locally advanced esophageal cancer tumours.
    


Intervention name(s): Nimotuzumab
Intervention type(s): Drug
Intervention MeSH terms: Nimotuzumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nimotuzumab esophageal chemo-radiotherapy
Health Benefits of Functional Oil (Mega 3 Fatty Acids From Fish Oil) on Obese People
Condition: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      Examine the effects and safety of functional oil (olive oil with omega 3 fatty acids from
      fish oil) on different inflammatory markers in obese subjects with dietary intervention for
      weight lost.
    


Intervention name(s): functional oil; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug with peripheral stem cell
      transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more
      tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus
      peripheral stem cell transplantation in treating patients with stage III or stage IV ovarian
      epithelial cancer.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the complete response rates, event free survival, and overall
      survival of patients with recently diagnosed stage III or IV ovarian epithelial cancer
      receiving carmustine plus melphalan followed by consolidation therapy after having undergone
      surgical debulking. II. Evaluate the therapy related mortality associated with the
      autotransplant and the consolidation therapy in these patients. III. Evaluate the quality of
      life in this patient population.

      OUTLINE: Patients are stratified by stage (III vs IV) and volume of residual disease (less
      than 3 cm vs at least 3 cm). Approximately 10-15 days after surgery, patients receive
      filgrastim (G-CSF) subcutaneously daily until all peripheral blood stem cell (PBSC)
      collections have been completed. Patients then receive carmustine IV over 2 hours on day -2
      and melphalan IV over 20 minutes on day -1. Peripheral blood stem cells are infused 24 hours
      after melphalan on day 0. Patients receive G-CSF subcutaneously beginning on day 6 and
      continuing until granulocytes have recovered. Three months after the PBSC infusion, patients
      receive consolidation therapy with paclitaxel IV over 6 hours on day 2 and cisplatin IV over
      24 hours on day 3. Consolidation treatment is repeated every 3 months for a total of 4
      courses. Quality of life questionnaires are completed prior to PBSC transplant, before
      discharge after transplant, before each consolidation treatment, and 3 months after the last
      consolidation course. Patients are followed at least every 3 months for the first 2 years,
      and then every 6 months thereafter.

      PROJECTED ACCRUAL: An estimated 32 patients will be accrued into this study over 3-4 years.
    

Intervention name(s): filgrastim; carmustine; cisplatin; melphalan; paclitaxel; peripheral blood stem cell transplantation; surgical procedure
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Paclitaxel; Melphalan; Carmustine
Primary purpose: Treatment
Keywords: stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; recurrent ovarian epithelial cancer
Investigate the Exposure to Selected Smoke Constituents in Smokers Switching to Distillation Based Smoking Article
Condition: Smoking
Study type: Interventional

Summary: 
      The overall purpose of this clinical study conducted in confinement under well-defined
      conditions is to obtain initial data on the levels of human body exposure to selected smoked
      constituents of the SMAR cigarette.

      The main objective of this study is to compare the biomarkers of exposure to cigarette smoke
      constituents in smokers switching to SMAR and to biomarkers in smokers of conventional
      cigarettes (CC). The biomarkers of exposure will be measured in blood and urine samples
      collected from the subjects. Moreover, the biomarkers in subjects smoking conventional or
      SMAR cigarettes will be compared with those biomarkers in smokers who stop smoking for 5
      days. The short term safety of this new product will also be evaluated.
    

Detailed description: 
      This is a controlled, randomised, open-label, 3-arm parallel single centre confinement study
      to investigate exposure to selected smoke constituents in smokers switching from CC to SMAR
      for 5 days.

      112 eligible subjects will be randomised to the 3 study arms: SMAR, conventional cigarettes
      (CC) and smoking cessation (SC) in a 2:1:1 ratio.

      Following the screening visit (within 4 weeks prior to the day of admission), the study will
      be run over an 8-day period in a confined environment, consisting of the admission day (D-2),
      a 2-day baseline period (D-1 and D0), and a 5-day exposure period (D1 to D5). Subjects will
      be discharged in the morning of D6. From the discharge of the subject, a 7-day safety
      follow-up period will be carried out (until D13).
    

Intervention name(s): Distillation based smoking article (SMAR cigarette); conventional cigarette; smoking cessation
Intervention type(s): Other; Other; Other
Intervention description(s): Subjects randomised to the SMAR arm will be trained by the site staff on the usage of SMAR and the corresponding lighter prior to smoking the first SMAR. Subjects will be allowed to smoke SMAR without any limit on consumption during the designated smoking times but have to request each SMAR from the site staff when they wish to smoke.; Subjects randomised to the CC arm will continue to smoke their preferred CC brand during the exposure period. Subjects will be allowed to smoke without any limit on consumption during the designated smoking times but will have to request each CC from the site staff when they wish to smoke.; Subjects will not be allowed to smoke any cigarettes or to use any other nicotine/tobacco-containing products during the 5 days following randomisation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Smokers with acceptable health conditions