cyrilzakka/clinical-trials huggingface dataset:
The Effect of COVID-19 Pandemia on Follow up of Patients With Chronic Kidney Disease

COVID-19 pandemic affected the admission of patients to the hospital especially the older patients (\> 65 years old) because of curfews and the reluctance of patients to apply to the hospitals. Chronic kidney disease is characterized with the progressive loss of kidney function over the time and regular follow-up of patients for their kidney function and treatment of complications is recommended in these patients.

The chronis kidney disease patients followed in Nephrology outpatient unit are going to be enrolled in the study and their kidney functions (calculated with the mdrd formula to asses the estimated glomerular filtration rate (eGFR)) will be evaluated 6 months before and after the COVID-19 pandemia. And the rate of initiation of renal replacement therapies and the change in proteinuria will be evaluated 6 months before and after the COVID-19 pandemic.

Eligibility Criteria:
Inclusion Criteria:

* patients with chronic kidney disease on regular follow-up for 6 months before the COVID19 pandemic.

Exclusion Criteria:

* patients without chronic kidney disease
* patients not on routine follow-up for 6 months before the COVID19 pandemic
Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B

This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Male, age below 6 years at the time of signing informed consent
* Patients with the diagnosis of haemophilia B (FIX (coagulation factor IX) activity level below or equal to 2%) based on medical records or central laboratory results
* Previously untreated or exposed to FIX containing products less than or equal to 3 exposure days (5 previous exposures to blood components is acceptable)

Exclusion Criteria:

* Any history of FIX inhibitors (defined by medical records)
* Known or suspected hypersensitivity to trial product or related products
* Previous participation in this trial. Participation is defined as first dose administered of trial product
* Receipt of any investigational medicinal product within 30 days before screening
* Congenital or acquired coagulation disorder other than haemophilia B
* Any chronic disorder or severe disease which, in the opinion of the Investigator, might jeopardise the patient's safety or compliance with the protocol
* Patient's parent(s)/LAR(s) (legally acceptable representative) mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation
"Lactobacillus Crispatus M247, LSIL and Microbiota"

Patients affected by ASC-US/ low-grade HPV cervical lesions will be randomly assigned to treatment arm vs control arm. The treatment arm will include the characterization of the vaginal microbiota at enrollment (T0), 4 months of oral treatment with Lactobacillus Crispatus M 247 (1 buccal stick Die), characterization of the vaginal microbiota at 1 month post treatment (T5 m). The vaginal microbiota will be evaluated by Danagene microbiome vaginal DNA KIT-XMICROGem (XBIOGem) test, with amplification of the variable regions of the 16S ribosomal RNA gene, using the MICROBIOTA kit (CE-IVD - ARROW diagnostics) and second generation sequencing technologies (NGS on Illumina MiSeq platform). The control arm will provide for the characterization of the vaginal microbiota at the same timescales. Patients will be given a medical history questionnaire at T0 and T5m


Eligibility Criteria:
Inclusion Criteria:

* Pap smear ASCUS or L-SIL
* HPV test + (HPV-HR e/o HPV-LR)

Exclusion Criteria:

* Hormonal therapy (OC, ring, patch, implant)
* Pregnancy status
* Immunosuppressive therapies
* Ongoing HPV vaccination
Identify Proteomic Biomarkers for Outcome Prediction of Locoregional Treatments for HCC

This study will enroll patients with hepatocellular carcinoma being planned for TACE or other standard of care treatment (such as denovo ablation or Y90) and obtain blood samples pre and post treatment procedure for biomarker identification using bead based X-aptamer library. No intervention is planned.

This is a prospective, non-blinded, multi-arm study. Patients at 18 - 70 years old with liver cancer will be enrolled.

The approach is to identify novel proteomic biomarkers for HCC patients treated with Lipiodol TACE, denovo ablation or Y90 using beads-based X-aptamer library, then validate and create a biomarker panel that can be used to predict the outcome of HCC post treatment.

Lipiodol TACE, denovo ablation, or Y90 will be done as standard of care and the only thing done as research will be blood draws pre and post-TACE.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and the willingness to sign a written informed consent.
2. Male or female aged 18-70years.
3. Diagnosed with primary or metastatic liver cancer.
4. Scheduled to undergo Lipoidal TACE, denovo ablation, or Yttrium-90 (Y90) radioembolization as part of standard of care.

Exclusion Criteria:

Subjects who have received chemotherapy, radiation or surgery for HCC.
Reversal of Dabigatran With Prothrombin Complex Concentrate

The purpose of this study is to investigate whether Prothrombin Complex Concentrate (PCC) is effective in reversing the anticoagulant effect of Dabigatran, as assessed by two modified skin-bleeding tests.

There is currently no treatment widely available for immediate reversal of Dabigatran anticoagulant effects, e.g. in case of major bleeding or when emergency surgery or invasive procedures are indicated.

Treatment with prothrombin complex concentrate (PCC) seems effective in reducing blood loss in animal models, but previous studies in humans have failed to show an effect on blood coagulation parameters. Recently, two novel methods of skin blood loss, one called "shed blood" and another "washed blood" were able to measure effects of anticoagulation, either as the inhibition of fibrin formation at the wound site by measuring Fibrinopeptide A (FPA) or as elevated blood loss, respectively, after oral administration of Dabigatran in healthy volunteers.

The investigators hypothesise that the shed/washed blood methods are able to measure Dabigatran reversal following administration of PCC (Beriplex).

The study will be performed as a randomised double blind cross-over study and 12 healthy human male subjects will be enrolled. Subjects will take Dabigatran 300 mg b.i.d. on day -2, -1 and 0. After the fifth dose (on day 0), subjects will be randomised to receive Beriplex (50 IU/kg) or a similar volume of saline as a single bolus dose i.v. over 20 minutes. After a 10 day minimum wash-out period this procedure will be repeated, and the alternative treatment (Saline or Beriplex) is administered.

The Shed / Washed Blood measurements will be performed at different time points before and after starting oral anticoagulants and before and after administration of Beriplex/Saline.

In addition to the Shed / Washed blood tests, several ex vivo standard coagulation tests will be performed. These include: activated partial thromboplastin time (aPTT), prothrombin time (PT), diluted thrombin time (DTT/Hemoclot), Dabigatran plasma levels (using liquid chromatography-tandem mass spectrometry (LC-MS/MS)), endogenous thrombin generation (ETG) and pre and post factor II, VII, IX and X.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* Age between 18 and 50 years
* Weight \<100 kg
* Signed informed consent
* eGFR ≥ 80ml/min\*1.73m2

Exclusion Criteria:

* History of allergic reaction to blood products
* Current participation in any other investigational drug study or within the past 30 days
* Increased bleeding tendency or history of thrombosis
* Anticoagulant medication, platelet aggregation inhibitors or NSAIDs
* Use of any medication 14 days before start of dabigatran intake
Ethical Crossroads in Nursing Education

In conclusion, understanding the variables influencing ethical decision-making among nursing students is crucial for developing interventions to minimize moral distress and promoting their ability to cope with ethical issues and dilemmas. While acknowledging the existence of ethical challenges, it is noteworthy that there is a dearth of studies investigating the intricate relationship between ethical sensitivity and the development of professional identity among nursing students. This research aims to fill this gap, advancing our understanding and providing valuable insights for shaping effective educational practices. In this improvement, the research problem is clearly stated: the need to explore the relationship between ethical sensitivity and professional identity among nursing students, with a call for further research to bridge the existing gap.

In light of the identified research gap regarding the correlation between ethical sensitivity and the development of professional identity among nursing students, this study seeks to answer the following question: How does ethical sensitivity influence the formation of professional identity in nursing students within the context of contemporary healthcare environments, characterized by evolving technology and complex health systems?


Eligibility Criteria:
Inclusion Criteria:

- Participants will be recruited from diverse online communities, including platforms such as Facebook, WhatsApp, and Telegram. The decision to utilize these social media channels is based on their extensive usage within the target population, ensuring effective outreach and active participation. The undergraduate nursing students at the college are expected to establish dedicated social media groups for each academic level.

Exclusion Criteria:

* Students not from nursing background education
Effects of Post Isometric Relaxation and Post Facilitation Stretching on Young Fast Bowlers

The quadratus lumborum muscle exhibited the highest degree of asymmetry in fast bowlers with low back pain, the identification and correction of this asymmetry is always of interest. Fast bowlers in cricket are more likely to experience non-contact LBP if they use improper technique, prepare less physically, ball too hard, or take on an excessive workload. The quadratus lumborum muscle exhibited the highest degree of asymmetry in fast bowlers with low back pain due to extreme side flexion at non-dominant side and hence results in QL tightness at that side.

The study design will be a Randomized Controlled Trial. This study will be conducted in Pakistan Sports Board (PSB) Lahore. The study will be completed within the time duration of eight to ten months after the approval of the synopsis. The sample size will be 34 subjects. Non-probability convenient sampling technique will be used to recruit the individuals for the study. Then randomization will be done by lottery method to divide the individuals into 2 treatment groups. The experimental group A will be given Post isometric relaxation for 20 minutes for 4 weeks (four times per week) on the other hand experimental group B will receive Post facilitation stretching and after that measure their pre-post values on SPSS. Pain will be measured with VAS, range of motion with inclinometer and functional disability with athlete's disability index questionnaire. In this study, it will be aimed to examine the comparative effects of both techniques that affect pain, range of motion and functional disability with quadratus lumborum tightness in young fast bowlers.

The main objective of this study is to apply post isometric relaxation and post facilitation stretching techniques and to compare the results to identify their influence on pain, range of motion and functional disability on quadratus lumborum tightness in young fast bowlers.

Eligibility Criteria:
Inclusion Criteria:

* Age15-19years
* both male and female fast bowlers
* passive pelvic transverse gliding test for Quadratus lumborum tightness +ve
* Low back pain \> 6 weeks
* Training sessions of at least 3 days/week

Exclusion Criteria:

1. Congenital causes (Spina bifida, Scoliosis, Spondylosis, Spondylolisthesis)
2. Traumatic cause

   * Prolapsed intervertebral disc
   * fracture of vertebral column
3. Inflammatory cause

   * Ankylosing spondylosis
   * Pott's spine
4. Neoplastic cause

   * Benign
   * Malignant
5. Radiculopathy
6. Any spinal surgery
7. Gynecological cause
Evaluation of Incisors' Position Following Anterior Segment Retraction

There's scarcity in literature concerning the issue of anterior segment retraction technique and its effect on anterior teeth position. Therefore, a randomized clinical trial has been chosen to investigate this issue, aiming to support clinicians with the best guidelines for anterior segment retraction.

Thirty females with bimaxillary protrusion were randomly allocated into two groups. In one group, anterior segment retraction was commenced using an elastomeric chain rendering 160 g/side extending between mini-screw implant and a hook crimped on 0.017- by 0.025-inch stainless steel wire distal to the lateral incisor. In the other group, anterior segment retraction was done using closing T-loops fabricated from 0.017- by 0.025-inch titanium molybdenum alloy (TMA) wire rendering comparable retraction force. Three-dimensional analysis of incisors' buccolingual (BL)- torque, mesiodistal (MD)- tip, vertical position changes and root resorption were assessed using cone beam computed tomography scans.

Eligibility Criteria:
Inclusion Criteria:

* Female patients (Age 13- 25 y)
* Class I molar relation (Angle's classification)
* Bimaxillary protrusion requiring extraction of four first premolars and maximum anchorage.
* full permanent dentition (except 3rd molars)
* Good general and oral health

Exclusion Criteria:

* Systemic disease or syndromes or on anti-inflammatory medication.
* Extracted or missing permanent teeth (other than 3rd molars)
* Badly decayed teeth (other than 1st premolars)
* Parafunctional habits
* History of previous orthodontics treatment
Clinical Trial of Tumor Cell-derived Microparticles Packaging Chemotherapeutic Drugs to Treat Malignant Pleural Effusion

The study is to investigate the anticancer effect and the related immunological mechanism of MTX-ATMPs in the treatment of malignant pleural effusion.

Malignant pleural effusion(MPE) as a common complication of advanced lung cancer is lack of efficient treatments. The investigators have successfully produced tumor cell-derived microparticles packaging chemotherapy drugs and confirmed that this new integrative targeted biochemotherapy treatment could effectively restrain tumor growth at cellular and animal levels.This new method could control tumor growth in vivo effectively and induced pleural adhesion in the early clinical study. So the investigators attempt to explore the anticancer effect and related immune regulation mechanism of methotrexate-autologous tumor derived microparticles (MTX-ATMPs) in MPE treatment. The tumor cells in the malignant pleural effusion are prepared by screening, then MTX-ATMPs are made. Participants enrolled are randomly assigned to experimental and control group, each of them is injected with the prepared drug once in two days until the malignant pleural effusion are disappeared or the treatment cycle has been six times. During or after the whole treatment, reactions to each treatment of the participants are carefully followed up.

Eligibility Criteria:
Inclusion Criteria:

1. The diagnosis of lung cancer and malignant pleural effusion was confirmed by pathology and / or pleural fluid cytology;
2. The routine surgery or systemic radio/chemotherapy was ineffective, the MPE relapsed, or routine treatment therapy was given up by self-causes;
3. stable vital sign with KPS(Karnofsky Performance Status) index more than 60;
4. 18-70 years old;
5. normal haematopoietic function of bone marrow, no hemorrhagic tendency, blood routine test: HGB\>=100g/L, WBC\>4.0\*10\^9/L, PLT\>80\*10\^9/L, serum ALT, AST within 2 times upper limit of normal, BUN within 1.5 time upper limit of normal, creatinine within normal range, normal EKG;
6. agreed to participate in the study and sign an informed consent;
7. without other severe comorbidities.

Exclusion Criteria:

1. lactating or pregnant patients;
2. allergy to multiple drugs;
3. with other severe comorbidities or psychological diseases;
4. severe infection;
5. participation in other clinical trials within the recent three months.
Measurement of High Order Aberrations in Late Stages Keratoconus

The instrument that will be used in the study is the Murcia monocular Adaptive Optics Visual simulator (AOVIS-I). The system provides an objective characterization of the optical quality of the patient's eye by application of wave-front sensing technology. The optical condition of every eye is represented by its wave aberration. This characterization overcomes the current description based only in refractive errors. This provides an accurate description of the optics of the eye based on the assessment of the whole set of ocular aberrations. The particular wave-front sensor is of a Hartmann-Shack type. One characteristics of this wave-front sensor is its high dynamic range allowing measuring highly aberrated eyes, such as patients with keratoconus.

The complete procedure in one patient takes less than 5 minutes and is completely non-invasive.

Eligibility Criteria:
Inclusion Criteria:

* to be able to understand an information and give a consent
* patients over 18
* patients with keratoconus
* affiliated to medical insurance.

Exclusion Criteria:

* non keratoconus patients
* patients under 18
* pregnant women or nursing mothers
* ocular surgery 90 days before inclusion
* ocular infection
* keratitis
* restless patients
Efficacy and Safety of VDA-1102 Ointment in the Treatment of Actinic Keratosis

This Phase 2 clinical trial is a multi-center, randomized, double-blind, placebo-controlled, multiple-dose, parallel-cohort study to assess the efficacy, safety and tolerability of VDA-1102 in the treatment of actinic keratosis (AK) on the head of male and female adult subjects.

Approximately 84 subjects who meet the study's enrollment criteria at the completion of the Screening Period will be randomized to receive 5% or 10% VDA-1102, or matched-placebo. During the Treatment Period, study drug will be applied once-daily for 28 days to a 25 square centimeter area of skin containing 4-8 actinic keratosis lesions on the face or scalp. Subjects will be followed for an additional 28 days (Observation Period) wherein no study drug will be applied.

The purpose of the study is to determine whether once-daily application of VDA-1102 ointment for 28 days is effective and well-tolerated in the treatment of actinic keratosis of the face and scalp.

Eligibility Criteria:
Main Inclusion Criteria:

* Subject has a minimum of 4 and a maximum of 8 discrete Grade 1-2 AK lesions within a single 25 square centimeter area of skin on their scalp or face

Main Exclusion Criteria:

* Subject is: (a) pregnant; (b) lactating; (c) planning to become pregnant during the study, or (d) fertile and they or their fertile partner is unable or unwilling to use the required contraceptive methods
* Subject is immunosuppressed
* Subject has used any of the following topical treatments in the Treatment Field: (1) topical retinoids within 8 weeks of Screening or (2) micro-dermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod, ingenol, or other topical treatments for AK or that might impact AK within 12 weeks of Screening.
* Subject has used systemic retinoid therapy within 6 months of Screening Visit.
Modification and Evaluation of the Educational Mobile Games Heroes of Knowledge in Children

The goal of the proposed research is to adapt and rigorously evaluate educational mobile games, designed as a downloadable mobile apps to be played on smartphones or tablets. Investigators will be partnering with Yogome for this project. Yogame is a company dedicated to creating educational games that aim to reinforce knowledge acquired in school and help children learn new things in an entertaining and fun way.

This study will modify and evaluate the Heroes of Knowledge (HoK) games, beginning with the Math Heroes game which was designed to be played for up to 8 hours. Other games in the HoK series may be included in this process if they are fully developed and available for testing. In testing the efficacy of the Math Heroes game, children will play the game for 1-1.5 hours per week, 2-3 times per week, for 2-4 weeks (to accumulate 6-8 hours of game play). The game has been designed to target math knowledge skills identified by the Common Core Standards for Mathematics (2012).

Eligibility Criteria:
Inclusion Criteria:

* Participants must be in first grade and interested and able to participate in a mobile app-based videogame (willing to sit with a tablet computer for approximately 1-1.5 hours, 2-3 times per week for 2-4 weeks).

Exclusion Criteria:

* None
The Motor Imagery Based on Action Observation Treatment on Dysphagia in Wallenberg Syndrome

The goal of this clinical trial is to learn about on dysphagia in wallenberg syndrome. The main questions it aims to answer are:

* the efficacy of motor imagery based on action observation treatment in the rehabilitation of patients with dysphagia in Wallenberg syndrome.
* apply functional near infrared spectroscopy to explore the mechanism of action of this therapy.

Participants received conventional dysphagia treatment and motor imagery based on action observation treatment once a day for 14 days. Researchers compared the control group to see the effect and mechanism of motor imagery based on action observation treatment.

The goal of this clinical trial is to learn about on dysphagia in wallenberg syndrome. The main questions it aims to answer are:

* the efficacy of motor imagery based on action observation treatment in the rehabilitation of patients with dysphagia in Wallenberg syndrome.
* apply functional near infrared spectroscopy to explore the mechanism of action of this therapy.

Both groups received conventional dysphagia treatment, and the experimental group underwent the addition of motor imagery based on action observation treatment to the control group once a day for 14 days. Overall swallowing function was assessed before treatment and after 14 days of intervention. Meanwhile, the functional near infrared spectroscopy was used to detect changes in cerebral hemodynamics during the execution of volitional swallowing task and swallowing motor imagery.

Eligibility Criteria:
Inclusion Criteria:

* age ranged from 18-80 years and right-handed;
* first onset, vital signs stable and conscious;
* the dysphagia confirmed by videofluoroscopic swallowing study;
* no cognitive impairment, the mini-mental state examination score: \>17 for those with an illiterate education, \>20 for those with an elementary education, and \>24 for those with a secondary education and above;
* good motor imagery ability with kinesthetic and visual imagery questionnaire-10 score ≥25;
* cranial integrity without craniotomy and/or craniectomy;
* patient and/or his/her relative agrees and signs written informed consent.

Exclusion Criteria:

* combined ischemic foci at other sites;
* presence of organic swallowing dysfunction or pre-existing dysphagia due to Parkinson's disease, dementia, and others;
* severe cardiac, pulmonary, hepatic, and renal insufficiency and vital organ failure;
* significant psychological disorders such as anxiety and depression;
* infected or broken skin on the head;
* poorly controlled epilepsy;
* poor patient compliance.