bioihbjkbjnl/mcl2 huggingface dataset:
Development of an Optimal Algorithm for the Management of Patients With Retinal Pigment Epithelium Detachment in Neovascular Age-related Macular Degeneration Using Artificial Intelligence
Condition: Neovascular Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Study type: Observational

Summary: 
      The study involves the development of an algorithm for predicting anatomical and functional
      results of therapy with angiogenesis inhibitors in patients with retinal pigment epithelium
      detachments in neovascular age-related macular degeneration, based on primary optical
      coherence tomography of the macular zone and clinical data.
    

Detailed description: 
      Patients were divided into 3 groups according to the results of therapy: adhesion of
      detachment, lack of adherence to detachment, rupture of detachment. For these groups, OCT
      images of the macular zone with maximum detachment before therapy are selected. These images,
      along with other clinical parameters, are input to the algorithm. The result is one of the 3
      treatment outcomes listed above. The methods that will be used to develop the algorithm
      include methods for processing and transforming data, deep machine learning, metrics for
      calculating the accuracy of algorithms.
    

Intervention name(s): Anti-vascular endothelial growth factor therapy
Intervention type(s): Procedure
Intervention description(s): 0.05 ml anti-VEGF, intravitreal, monthly
Other intervention name(s): anti-VEGF
Intervention MeSH terms: Mitogens; Endothelial Growth Factors
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with retinal pigment epithelium detachments with age-related neovascular macular
        degeneration
      
Keywords: Machine learning; Artificial intelligence; anti-VEGF therapy; AMD
Relationship of Patient-Specific Functional Scale With Shoulder Functions: A Prospective Study
Condition: Shoulder Impingement; Frozen Shoulder; Humeral Fractures; Rotator Cuff Tears; Disability Physical; Pain, Shoulder
MeSH terms: Shoulder Impingement Syndrome; Bursitis; Shoulder Pain; Rotator Cuff Injuries; Humeral Fractures
Study type: Observational [Patient Registry]

Summary: 
      The aim of the study is to examine the relationship between the Patient- Specific Functional
      Scale (PSFS) and shoulder functions in the physiotherapy and rehabilitation program applied
      to patients with shoulder problems.
    


Intervention name(s): Shoulder disability; Shoulder Range of Motion; Pain Intensity
Intervention type(s): Behavioral; Device; Behavioral
Intervention description(s): Shoulder disability was evaluated with Patient-specific functional scale, the disabilities of the shoulder, arm and hand questionnaire, and the upper extremity functional index.
First assessment was applied when patients came to physical therapy clinic at first.
Second assessment was repeated after 6 weeks.; Shoulder range of motion was evaluated with universal goniometer. First assessment was applied when patients came to physical therapy clinic at first.
Second assessment was repeated after 6 weeks.; Pain intensity was evaluated with Numeric Pain Rating Scale. First assessment was applied when patients came to physical therapy clinic at first.
Second assessment was repeated after 6 weeks.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with shoulder problems
First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4011499 in Healthy Participants
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This FTIH study aims to evaluate the safety, tolerability and PK of the novel investigational
      Human immunodeficiency virus (HIV)-1 capsid inhibitor VH4011499 in healthy adults. The study
      will be conducted in 3 parts: Part 1 will investigate single ascending doses (SAD) and Part 2
      will investigate multiple ascending doses (MAD). Part 3 will investigate single dose of a new
      formulation of VH4011499. The transition from SAD to MAD will be based on the assessment of
      the Safety and Dose Escalation Committee.
    


Intervention name(s): VH4011499; Placebo; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): VH4011499 will be administered.; Placebo will be administered.; Midazolam will be administered
Other intervention name(s): GSK4011499
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This is a randomized and placebo-controlled study.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GSK4011499; VH4011499; First-time-in-human; HIV-1 capsid inhibitor; Single ascending doses; Multiple ascending doses; Drug-drug Interaction
Diet Induced Ketosis for Patients With Posttraumatic Stress Disorder (PTSD), a Feasibility Study
Condition: PTSD; Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Many patients suffering from posttraumatic stress disorder (PTSD) are resistant to
      established treatment consisting of psychotherapy. Patients often go years with this
      debilitating disorder without experiencing sufficient improvement. Approximately 1/3 of
      patients will drop out of treatment because of psychological burden and overactivation. A
      novel ketogenic diet treatment could amend established treatment, and potentially upregulate
      the threshold for exciting neurons in dysfunctional brain regions, mediated through various
      mechanisms. This may reduce PTSD symptoms, and thus enabling patients to respond to
      psychological treatment without getting overactivated and unable to process trauma. The
      purpose of this study is to investigate whether it is possible to carry out a ketogenic diet
      therapy for patients with PTSD for four weeks.
    

Detailed description: 
      The study aims to include 10 PTSD patients. If a participant drops out of the study, or if
      the study is otherwise terminated for a participant, another patient will be recruited until
      10 have completed the study. The primary objectives of this feasibility study are to
      investigate if it is possbile to carry out a ketogenic diet therapy for patients with PTSD
      for 4 weeks, and systematically gain insight in all challenges relating to these objectives.
      The participants will follow a ketogenic diet for 4 weeks, and they are asked to self report
      daily on results from finger pricking blood measurements (glucose and betahydroxybutyrate
      (BHB)) to establish they are in a ketogenic state and are compliant to diet. Participants
      will also report food intake and side effects daily to be evaluated by the principal
      investigator. Participants are further asked to specify and elaborate on which adverse
      effects or other reasons as to why it is challenging to follow the study diet and/or
      procedures. The study lacks in power to statistically evaluate if ketosis has any effect on
      PTSD symptoms, however this secondary objective will be preliminary evaluated.
    

Intervention name(s): Ketogenic Diet
Intervention type(s): Other
Intervention description(s): The intervention is a ketogenic diet based on high-fat ketogenic meals prepared by the study participants, complemented with ketogenic food products from Natural Ketosis and Vitaflo. Exogenous ketones are provided by Audacious Nutrition. The macronutrient composition of the ketogenic diet given approx.: Fat 87 E%, Carbohydrate 3 E%, Protein 10 E%,
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Distribution of FMT After Delivery by · Lower GI Endoscopy vs Enema With and Without Positioning of the Patient
Condition: Fecal Microbiota Transplantation
Study type: Interventional

Summary: 
      While delivery of an FMT-treatment to the cecum is visualized in a lower GI-endoscopy, it is
      uncertain whether delivery by enema distributes the FMT to the proximal segments of the
      colon. Positioning of the patient during the enema procedure may improve distribution to the
      proximal colon. Differences in distribution may explain the wide effect range and inferiority
      when enema is compared to delivery by lower GI endoscopy. Thus, in this study we will compare
      the distribution of FMT from delivery by lower GI endoscopy versus enema with and without
      positioning of the patient. We will use contrast fluid as a surrogate liquid for FMT to
      project the distribution on colon X-ray pictures. To our knowledge this is not done in any
      previous study.
    


Intervention name(s): Delivery of contrast fluid by lower GI endoscopy; Delivery of contrast fluid by enema with and without positioning
Intervention type(s): Other; Other
Intervention description(s): Each participant will receive one delivery of 440 ml contrast fluid by lower GI endoscopy to the cecum of the colon. The participants perform a bowel lavage using Sodiumpicosulphate/Magnesiumcitrate (Picoprep, Ferring) 24 hours before the delivery of contrast fluid. An colon X-ray is obtained within 10 minutes after the contrast fluid is delivered. The participants is in a supine position fram delivery and until the colon x-ray is obtained.; Each participant will receive one delivery of 440 ml contrast fluid by enema. The participants perform a bowel lavage using Sodiumpicosulphate/Magnesiumcitrate (Picoprep, Ferring) 24 hours before the delivery of contrast fluid. The enema procedure includes:
The participant lies on his/her left side in neutral position when the enema is delivered
X-ray of the colon is obtained with the participant lying on his/her back.
The participant is positioned back to his/her left sided position and tilted in a Trendelenburg position. The position is held for two minutes
The participant is turned to an abdominal position while the bed remains tilted in Trendelenburg position.
Participant turne to the right side. When positioned the bed is tilted the opposite way (anti-Trendelenburg.) The position is held for two minutes.
A second colon X-ray is obtained after the participants has rested for ten minutes in a supine neutral position
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Low-calorie Diet and Orange Juice on Body Weight and Metabolic Parameters of Obese Subjects
Condition: Obesity
Study type: Interventional

Summary: 
      This study aimed to verify if combination of a low calorie diet and orange juice consumption
      results in weight loss and ameliorates metabolic obesity-related biomarkers.
    

Detailed description: 
      Seventy-eight obese subjects aged 36 ± 1 years and BMI of 33 ± 3 kg were randomly divided
      into two parallel groups: (1) orange juice (n = 39), composed of individuals subjected to a
      diet low caloric diet and plus intake of 500 ml orange juice; (2) control (n = 39) composed
      of individuals subjected to a diet low in calories. The recruitment process began in
      September 2015, the intervention was carried out from October 2015 to January 2016, and the
      data analysis started in February 2016. The sample number took into account variances on body
      weight with a type I error α = 0.05 and a type II error β = 0.2 (80% power). The minimum
      sample size should have 36 individuals per group (n = 72), considering an approximately 15%
      dropout rate. Thus, the final sample size of study was constituted by 39 individuals per
      group (n = 78). Primary and secondary endpoints were the reduction of weight and modification
      of the levels of obesity-related metabolic biomarkers, respectively. Normality and
      homogeneity of data were tested. T-test was conducted to identify possible differences
      between OJ and control groups at baseline. A linear mixed-effects model was apply to
      determine the time effect within and between groups (post hoc), and P significance was set up
      ≤ 0.05. The assessment of body composition, metabolic biomarkers and food intake were
      analyzed over a 12-week intervention.
    

Intervention name(s): Orange juice (500 mL/d)
Intervention type(s): Other
Intervention description(s): Nutritionists prescribed a low-calorie diet that was estimated from total energy expenditure (TEE) for each individual minus 500 kcal per day (30% TEE). Both groups had the same diet plan based on individual weight. The dietary plan was composed of six meals/day: breakfast (fat-free milk and coffee; whole-grain bread with margarine, and an apple); snack 1 (250 mL OJ / banana and free-fat yogurt); lunch (brown rice, beans, grilled lean meat, salad, cooked vegetables); snack 2 (250 mL OJ / free-fat yogurt with oatmeal); dinner (brown rice, beans, grilled lean meat, cooked vegetables and salad); and snack 3 (salty crackers or oat cookies, tea without sugar). Body composition measurements were collected (monthly); blood samples and dietary questionnaires (every two weeks).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Orange juice; Low-calorie diet; Body composition; Weight-loss; Metabolic biomarkers; Obese
The Evaluation Clinical Results of Coronally Advanced Flap With Platelet Rich Fibrin
Condition: Root Coverage
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the clinical outcomes of platelet- rich fibrin and
      coronally advanced flap technique in the treatment of multiple gingival recessions in
      comparison with connective tissue graft technique.
    

Detailed description: 
      Aim of this study was to evaluate the clinical outcomes of platelet rich fibrin
      (PRF)+coronally advanced flap (CAF) technique in the treatment of multiple gingival
      recessions in comparison with connective tissue graft (CTG)+CAF technique.12 patients with
      bilateral Miller Class I multiple gingival recessions were treated with PRF+CAF (test group)
      and CTG+CAF (control group) technique in a split-mouth study design. Probing depth, recession
      depth (RD), clinical attachment level (CAL), recession width, position of gingival margin,
      papilla width, keratinized tissue height (KTH), keratinized tissue thickness (KTT) were
      measured at baseline and 3, 6 and 12 months after surgery. Root coverage (RC) and complete
      root coverage (CRC) ratios were evaluated post-operatively.
    

Intervention name(s): Platelet rich fibrin and coronally advanced flap; Connective tissue graft and coronally advanced flap
Intervention type(s): Procedure; Procedure
Intervention description(s): CAF were used in treatment arms. Root planning was performed on the exposed part of roots to provide more biocompatible surface for re-attachment. Two 10 cc tubes with clot activator were used to collect blood from the patient; blood was centrifuged at 2700 rpm for 12 min. PRF box was used to form fibrin clots into membranes. PRF was positioned at the level of the cemento-enamel junction (CEJ), and sutured on the periosteum bed with 6/0 absorbable sutures. Gingival margins on the flap were placed at least 1 mm coronally of the CEJ and sutured with 5/0 absorbable sutures. Sutures were removed at 2nd week.; Control sites were treated by coronally advanced flap (CAF) combined with connective tissue graft (CTG). CAF were used in both treatment arms. Root planning was performed on the exposed part of roots to provide more biocompatible surface for re-attachment. CTG was obtained with single incision method. CTG was positioned at the level of the cemento-enamel junction (CEJ), and sutured on the periosteum bed with 6/0 absorbable sutures. Gingival margins on the flap were placed at least 1 mm coronally of the CEJ and sutured with 5/0 absorbable sutures. Sutures were removed at 2nd week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gingival recession; Plastic surgery; Platelet rich fibrin; Connective tissue graft; Coronally advanced flap
Clinical Impact of COVID-19 by P.1 SARS-CoV-2 Lineage
Condition: Covid19; COVID-19 Pneumonia; SARS-CoV-2 Infection
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Since the first report of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
      variant of concern (VOC) P.1 in Manaus, Brazil, a rapid spread of this lineage across the
      country has been observed. Recent studies indicate that this variant is associated with
      higher transmissibility; it is not known whether it is associated with clinical severity and
      higher mortality rates.

      This is a retrospective cohort study carried out at Hospital de Clínicas de Porto Alegre.
      Adult patients aged 18 years or more and 65 years or less who were admitted to the hospital
      due to symptomatic COVID-19 from June 2020 to May 2021 and had a reverse
      transcriptase-polymerase chain reaction (RT-PCR) cycle threshold value for either SARS-CoV-2
      N1 or N2 target ≤ 25 were eligible to the study. Samples from 86 patients (43 from June 2020
      to November 2020 and 43 from February 2021 to May 2021) were sequenced for further
      evaluation. These dates were defined since the emergence of P.1 lineage in late January.

      Clinical data regarding ventilatory support, date of onset of symptoms, laboratory findings
      and mortality were collected from each patient. This retrospective cohort aims to assess
      whether the number of days needed for supplementary oxygen either by noninvasive ventilation
      or high-flow nasal cannula from onset of symptoms differs among patients infected with the
      P.1 SARS-CoV-2 variant and those infected with other variants.
    


Intervention name(s): No intervention performed
Intervention type(s): Other
Intervention description(s): Collection of clinical and laboratory data
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients aged 18 to 65 years, seeking medical care in Hospital de Clínicas de Porto Alegre
        due to symptomatic COVID-19, admitted from June to November 2020 or from February to May
        2021.
      
Biospecimen description: 
      RT-PCR positive for SARS-CoV-2
Genetic Abnormalities and Oxidative Stress in Sperm as Cause of Recurrent Miscarriage.
Condition: Recurrent Miscarriage
MeSH terms: Abortion, Spontaneous; Abortion, Habitual; Recurrence
Study type: Observational

Summary: 
      In recurrent miscarriage, the male factor has been poorly evaluated. In fact, in the vast
      majority of clinical protocols of recurrent miscarriage, the sperm is not considered or
      assessed. Recently, some studies have suggested the presence of genetic and metabolic sperm
      anomalies in couples suffering from repeated miscarriages. Specifically, DNA fragmentation
      and altered oxidative stress in the sperm and Y microdeletions from blood samples have been
      related to an increased risk of miscarriage.The aim of the present study is to compare these
      three parameters in: couples with recurrent miscarriage; oligozoospermic men with or without
      recurrent miscarriages; and healthy sperm donors, in order to determine their actual impact
      on this reproductive problem.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Couples with recurrent miscarriages
Comparison of Two Multifocal Contact Lenses Worn on a Daily Disposable Basis
Condition: Presbyopia; Myopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      The purpose of this trial is to evaluate and compare the clinical performance of two
      multifocal contact lenses.
    


Intervention name(s): Nelfilcon A multifocal contact lens, investigational; Nelfilcon A multifocal contact lens, commercial
Intervention type(s): Device; Device
Intervention description(s): Investigational, soft, multifocal contact lens for daily wear, daily disposable use.; Commercially marketed, soft, multifocal contact lens FDA-approved for daily wear, daily disposable use.
Other intervention name(s): Focus® DAILIES® Progressive
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Variation of Progesterone in IVF Cycles
Condition: Progesterone Resistance
Study type: Observational

Summary: 
      to examine if a natural daytime variation in progesterone levels may explain parts of the
      inconsistent findings from studies reporting divergent results concerning this matter and
      will be carried out by several blood samples from the same patient during the day of
      ovulation triggering.
    

Detailed description: 
      The impact of the progesterone level at the end of the follicular phase in stimulated
      IVF/ICSI cycles and its effect on the pregnancy rate and oocyte quality is controversial,
      which arises from conflicting results in retrospective studies and meta-analyses. This study
      is assumed to examine if a natural daytime variation in progesterone levels may explain parts
      of the inconsistent findings from studies reporting divergent results concerning this matter
      and will be carried out by several blood samples from the same patient during the day of
      ovulation triggering. If variation is present, the impact of variation on the developing
      oocyte and embryo quality will be estimated by embryo quality indicators.
    

Intervention name(s): Progesterone variation
Intervention type(s): Diagnostic Test
Intervention description(s): The potential gain for medical caretakers and patients would be a certainty if the progesterone level is affected by variations during daytime
Intervention MeSH terms: Progesterone
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient who will undergo IVF treatment
      
Biospecimen description: 
      Blood will be drawn. Each blood sample will consist of 10 cc of blood, to be centrifuged and
      the serum shared into 3 vials before freezing at minus 20 degrees.
Effects of Statin on Hepatocellular Carcinoma Recurrence After Liver Transplantation
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Recurrence
Study type: Observational

Summary: 
      This study aims to investigate whether statin therapy can help prevent recurrence of
      hepatocellular carcinoma (HCC) in transplant recipients who had liver transplantation for
      HCC. Multiple logistic regression analysis will be performed to evaluate the association
      between statin therapy and the risk of HCC recurrence after LT.
    


Intervention name(s): Statin
Intervention type(s): Drug
Intervention description(s): Patients who used statins over 1 month for the treatment of dyslipidemia after LT were enrolled as statin group.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients who received LT at the Severance Hospital from 2006 to 2016.