bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Group Culture in WOW Dishes of Human Embryos in Order to Optimize the Single Embryo Transfer (SET) Strategy.
Condition: Fertility
Study type: Interventional

Summary: 
      In cattle less than 10% of the embryos develop to the blastocyst stage when embryos are
      cultured individually, however when bovine embryos are cultured in groups a typical 25-35% of
      blastocysts can be observed. This tendency, i.e. improved embryo development in group
      culture, has also been demonstrated in other mammalian species, such as mouse, cat and human.
      The main reason for this beneficial outcome of group culture has been ascribed to the
      presence of autocrine factors, which are factors secreted by preimplantation embryos that act
      upon the embryo itself or the neighboring embryos .

      Although group culture systems are common in in vitro production systems for animal embryos,
      it is rarely done in human settings, where individual follow-up of the embryo during the
      whole culture period is of utmost importance. Recently a CE-labelled culture device has been
      designed for human embryos, that allow to combine the benefits of both group culture
      approaches and individual culture. The WOW dish is commercially available by Primo Vision and
      consists of 9 small microwells on the bottom of the plate, so that the embryos can be
      cultivated individually in a microwell, but covered by the same drop of culture medium.

      In this clinical randomized trial, 158 patients will be included of which half of the
      fertilized oocytes will be cultured individually (standard culture system) and half of the
      fertilized oocytes will be cultured in group in a WOW dish, both during five days of culture.
      The aim of this study is to increase the number of blastocysts suitable for transfer or
      cryopreservation by culturing the embryos in WOW dishes.
    


Intervention name(s): control group; Primo Vision embryo culture dish (CE labeled, Vitrolife)
Intervention type(s): Other; Device
Intervention description(s): standard IVF protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: reduced fertility
A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke
Condition: Acute Ischemic Stroke From Large Vessel Occlusion
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional

Summary: 
      This is a prospective, randomized, single blind, concurrent controlled, multi-center study.
      Patients presenting with symptoms of acute ischemic stroke who have evidence of a large
      vessel (2.5mm or greater in diameter) occlusion in the cerebral circulation will be assigned
      to either the Penumbra System with the Separator 3D or the Penumbra System without the
      Separator 3D. Each treated patient will be followed and assessed for 3 months after
      randomization. Up to 230 evaluable patients at up to 50 centers presenting with acute
      ischemic stroke in vessels accessible to the Penumbra Separator 3D System for
      revascularization within 8 hours of symptom onset. The hypothesis to be tested is that the
      safety and effectiveness of the Penumbra System with the Separator 3D for the
      revascularization of large vessel occlusion is not inferior to the Penumbra System alone.
    


Intervention name(s): Penumbra System with Separator 3D; Penumbra System alone
Intervention type(s): Device; Device
Intervention description(s): The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.; The Penumbra System® is a new generation of neuro-embolectomy devices specifically designed to remove thrombus through aspiration.The treatment paradigm of this System involves the introduction of the Reperfusion Catheter through a guide catheter into the intracranial vasculature, and guided over an appropriate guidewire to the site of primary occlusion. The Reperfusion Catheter is used in parallel with the Separator and an aspiration source (Aspiration Pump) to separate the thrombus and aspirate it from the occluded vessel.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: ischemic stroke; large vessel occlusion; mechanical thrombectomy; revascularization; Penumbra System; Separator 3D
Effect of Probiotics Containing Yogurts on the Composition of Biofilms in Patients Under Orthodontic Treatment
Condition: Dental Caries; Oral Health
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Aim: To assess in vivo if the intake of yogurt containing Bifidobacterium animalis ssp.
      lactis DN- 1173010 probiotic for a period of 2 weeks affects the salivary levels or biofilms
      of mutans streptococci and the lactobacilli of patients undergoing orthodontic treatment.
      Methods: A crossover, double-blind, randomized and placebo controlled clinical trial will be
      performed with 26 volunteers during 4 periods. During periods 2 and 4 (2 weeks each) the
      volunteers will have a daily ingestion of yogurt containing probiotic or of control yogurt
      which did not contain probiotic. Periods 1 and 3 were run-in and wash-out periods of 1 and 4
      weeks, respectively. Experimental samples of saliva and biofilm will be collected from each
      participant at the end of each phase. Mutans streptococci, lactobacilli, total aciduric
      microorganisms, Candida spp. and total cultivable microorganisms will be counted. The values
      before and after the treatment will be compared with Wilcoxon's test (p<0.05).
    


Intervention name(s): Yogurt containing probiotics; Placebo yogurt
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): patients assigned to this group will use a yogurt containing Bifidobacterium animalis once a day during 14 days before evaluation of the outcomes.; Patients will use a yogurt without probiotics once a day during 14 days before evaluation of outcomes
Other intervention name(s): yogurt containing Bifidobacterium animalis; Yogurt without probiotics
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Ecological Footprint Awareness Program in 60-72 Months Children
Condition: Program, Communication
Study type: Interventional

Summary: 
      This study aimed to evaluate the effectiveness of an ecological footprint awareness training
      program for children aged 60-72 months.
    

Detailed description: 
      This study was conducted using a cluster randomized controlled pretest-posttest experimental
      design. It was carried out in four kindergartens located in a city center between April and
      June 2023. Two of the kindergartens were assigned to the intervention group while the other
      two were assigned to the control group. Data was collected using the Ecological Footprint
      Awareness Scale for Children (EFAS-C). The training program was conducted with the children
      in the intervention group for four weeks, with a 40-minute session each week. The program
      covered one topic each week, which included waste management, water and energy use, food
      consumption, and transportation. The data was analyzed using descriptive statistics, paired
      groups t-test, and independent groups t-test, with a 95% confidence interval and p<.05
      significance level.
    

Intervention name(s): Ecological Footprint Awareness Program
Intervention type(s): Behavioral
Intervention description(s): The program was conducted for four weeks, one day each week, for 40 minutes. Each week, a different topic was addressed such as waste evaluation, water and energy usage, food consumption, and transportation. The program was created in line with expert opinions and literature. The sessions were based on the principles of the Social Cognitive Learning Theory, developed by Bandura, which includes mutual determinism, symbolization, anticipatory capacity, vicarious learning, self-regulation capacity, and self-judgment capacity. During each session, various techniques such as animation, drawing, storytelling, memory cards, and games were employed. To ensure the program's content was appropriate for children's development, the opinions of two experts from the child development department of the university were obtained.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was conducted using a cluster randomized controlled pretest-posttest experimental design. It was carried out in four kindergartens located in a city center between April and June 2023. Two of the kindergartens were assigned to the intervention group while the other two were assigned to the control group. Data was collected using the Ecological Footprint Awareness Scale for Children (EFAS-C). The training program was conducted with the children in the intervention group for four weeks, with a 40-minute session each week. The program covered one topic each week, which included waste management, water and energy use, food consumption, and transportation.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: environment; ecology; awareness; child
Connection to Care: Pilot Study of a Mobile Health Tool for Patients With Depression and Anxiety
Condition: Anxiety; Depression
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      This is a pilot feasibility study of a mobile health tool (smartphone app) for primary care
      patients receiving treatment for depression or anxiety delivered in an integrated primary
      care-based behavioral health program.
    

Detailed description: 
      This research is a feasibility pilot study of a smartphone app using mixed methods. The
      research seeks to answer the question: "Is a mobile health tool for patient self-management
      feasible, useful, appropriate, and acceptable for patients and care managers for patients
      with depression or anxiety treated in an integrated primary-care based behavioral health
      program?"
    

Intervention name(s): App for smartphone; smartphone
Intervention type(s): Behavioral; Device
Intervention description(s): A smartphone app will send psychoeducation and reminders to patients to complete self-report data, will collect passive data, and will provide aggregated information to a provider dashboard.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Biological Markers of Disease in the Prediction of Preterm Delivery, Preeclampsia and Intra-Uterine Growth Retardation: A Longtitudinal Study
Condition: Prenatal Care; Premature Birth
MeSH terms: Premature Birth; Pre-Eclampsia
Study type: Observational

Summary: 
      Preterm delivery, preeclampsia and intrauterine growth restriction are leading causes of
      perinatal morbidity and mortality. Efforts to treat these syndromes have not been effective,
      most likely becuase these obstetric complications are the clinical expression of adaptive
      mechanisms of host defense developed in response to pathologic insults. Since the ultimate
      pathologic basis of disease is unclear, therapy for these syndromes has been largely directed
      at symptoms, which appear late in the development of the disease. The main purpose of this
      study is to perform an early and comprehensive exploration of maternal and fetal factors that
      predict the subsequent develpment of these obstetrice complications, so that early medical
      interventions may be tested in patients at high and low risk for adverse perinatal outcome.
    

Detailed description: 
      Preterm delivery, preeclampsia and intrauterine growth restriction are leading causes of
      perinatal morbidity and mortality. Efforts to treat these syndromes have not been effective,
      most likely because these obstetric complications are the clinical expression of adaptive
      mechanisms of host defense developed in response to pathologic insults. Since the ultimate
      pathologic basis of disease is unclear, therapy for these syndromes has been largely directed
      at symptoms, which appear late in the development of the disease. The main purpose of this
      study is to perform an early and comprehensive exploration of maternal and fetal factors that
      predict the subsequent development of these obstetric complications, so that early medical
      interventions may be tested in patients at high and low risk for adverse perinatal outcome.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women attending prenatal clinics
      
Keywords: Perinatal Mortality; Perinatal Morbidity; Preterm Birth; Pregnancy Complications; Pregnancy; Natural History
Gemcitabine Plus High-Dose 5-Fu/Leucovorin in the Treatment of Advanced or Metastatic Carcinoma of the Biliary Tract
Condition: Biliary Tract Disease
MeSH terms: Biliary Tract Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label phase II trial with weekly gemcitabine plus high-dose 5-FU/leucovorin
      infusion (HDFL) for patients with advanced or metastatic carcinoma of the biliary tract. The
      primary endpoint is patients' response and the secondary endpoints are chemotherapy-related
      toxicity, time to disease progression and overall survival. .
    

Detailed description: 
      5-FU has been the mainstay of chemotherapeutic agents for gastrointestinal malignancies. The
      use of weekly 24-hour infusion of HDFL produces high clinical response in a variety of
      cancers, including colorectal, gastric and breast cancers, with minimal chemotherapy-related
      toxicity. Gemcitabine is a synthesized deoxycytidine analogue that is metabolized to dFdCTP
      in tumor cells and results in inhibition of DNA synthesis and depletion of normal cellular
      nucleotide pool. It has been shown to be active in the treatment of pancreatic cancer and
      non-small cell lung cancer. Since the biliary tract and the pancreas share a common embryonic
      origin and cancers from both sites are characterized by resistance to most chemotherapeutic
      agents, we postulate that gemcitabine may also be effective for cancer of the biliary tract.
      In our institution we have devised a regimen of weekly gemcitabine and 24-hour infusion of
      HDFL for patients with advanced or metastatic pancreatic adenocarcinoma. In 18 evaluable
      patients, 2 achieved a partial response and 3 minor response. The median duration of response
      was 4 months and the treatment-related toxicity was acceptable.

      The eligibility criteria are patients with advanced or metastatic carcinoma of the biliary
      tract who are not candidates for curative surgical treatment; good performance status; no
      prior chemotherapy; clinical measurable tumor; good organ function and good compliance. Each
      cycle of chemotherapy consists of 4 weeks. On days 1, 8 and 15, gemcitabine will be given by
      30-minute intravenous infusion and 5-FU and leucovorin by 24-hour continuous intravenous
      infusion. The dose of gemcitabine will be 1000 mg/m2. The doses of 5-FU will be 2000 mg/m2
      and leucovorin, 300 mg/m2. Treatment will continue until disease progresses or prohibitive
      toxicity develops. For patients with complete response (CR), chemotherapy will continue for 3
      additional courses after the documentation of CR. Estimated time for patient accrual is 3
      years.
    

Intervention name(s): Gemcitabine+5FU+Leucovorin
Intervention type(s): Drug
Intervention MeSH terms: Leucovorin; Gemcitabine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase III Study to Assess Efficacy and Safety of STALORAL® 300 IR Sublingual Immunotherapy (SLIT) in Asthmatic Patients Allergic to House-dust Mites
Condition: Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      A phase III study to assess the efficacy and safety of sublingual immunotherapy with STALORAL
      dust mites solution compared with placebo for reduction of asthma symptoms.
    


Intervention name(s): Staloral
Intervention type(s): Drug
Intervention description(s): Sublingual immunotherapy with Staloral dust mites solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allergy; SLIT; Asthma; House Dust Mites
Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism
Condition: Male Hypogonadism
MeSH terms: Hypogonadism; Eunuchism
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy (based on the pharmacokinetic profile
      of testosterone) and safety of TBS-1 in the treatment of hypogonadal men
    

Detailed description: 
      This study is a 4 Period study consists of 16 visits with overnight clinic stays that span
      over year to help determine the efficacy of TBS-1 gel administered twice daily (b.i.d) and
      three times daily (t.i.d)

      In addition, this study will investigate the safety and tolerability of TBS-1 after 90, 180
      and 360 days of treatment.
    

Intervention name(s): Testosterone; Testosterone
Intervention type(s): Drug; Drug
Intervention description(s): Intranasal testosterone; Intranasal testosterone
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ambulatory and Blood Pressure Variability Responses to Exercise in Normotensive and Hypertensive Women
Condition: Menopause; Exercise; Blood Pressure, High
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This study evaluated the differences between normotensive and hypertensive menopausal women
      in ambulatory and blood pressure variability responses to combined aerobic and resistance
      exercise.
    

Detailed description: 
      The differences in hypotensive and cardioprotective responses of exercise among menopausal
      hypertensive and normotensive women are still not very clear, mainly the responses of blood
      pressure variability. In this way, were evaluated 6 indices related to the variability of 24
      hour ambulatory pressure measurements in these women before and after 12 weeks of combined
      exercise training.
    

Intervention name(s): Combined Exercise Training
Intervention type(s): Other
Intervention description(s): The program consisted of 30 sessions of combined aerobic and resistance exercises training during 10 consecutive weeks. Each session lasted 45 minutes and consisted of 5 minutes warm-up, 20 minutes of resistance exercise and 20 minutes of aerobic exercise. The resistance training was performed in two sets of 15 repetitions in seven exercises of weight training (Based on 1 repetition maximum test - 1RM) for large muscle groups. The aerobic exercise was performed on a treadmill, at a speed of 5.5 km/h and intensity (imposed by treadmill inclination and heart rate) between ventilatory threshold 1 and 2 intensities. After 5 weeks of training, 1RM test was performed again to readjust the resistance load and aerobic intensity was readjusted by heart rate predicted in the incremental test.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Blood Pressure Variability; Ambulatorial Blood Pressure Monitoring; Combined Exercise
Cut Down on Carbohydrate Usage in the Diet of Type 2 Diabetes - Mechanisms of Effective Therapy of Diabetes by Selective Choice of Macronutrients - The Phenotype Study
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Scientific evidence for the dietary treatment of type 2 diabetes is insufficient. The
      investigators hypothesize that a lower carbohydrate content in the diabetic diet than the
      recommended 55 E% will decrease the postprandial glucose excursion, decrease insulinotropic
      factors like incretin hormones and decrease their insulinotropic effects due to their glucose
      dependency. This will reduce postprandial insulin concentration, resulting in an improved
      insulin sensitivity and glucose metabolism. This clinical study will examine in diabetic,
      prediabetic and healthy subjects the acute effects of short term highly controlled dietary
      low carbohydrate intervention on metabolic pathways with respect to insulin action,
      pancreatic islet function, lipid metabolism, incretin hormones, low grade inflammation in
      plasma and novel measures of fatty acid metabolism.
    


Intervention name(s): Low carbohydrate meals; Standard carbohydrate meals
Intervention type(s): Other; Other
Intervention description(s): Meal macronutritional energy composition:
Carbohydrate 30% Protein 30% Fat 40%; Meal macronutritional energy composition:
Carbohydrate 55% Protein 15% Fat 30%
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science