cyrilzakka/clinical-trials huggingface dataset:
The Prediction of Intracranial Pressure and Clinical Outcome by Transcranial Doppler in Neurocritical Patients

The purpose of this study is to use transcranial Doppler (TCD) to predict intracranial pressure (ICP) and clinical outcome of neurocritical patients.

Transcranial Doppler (TCD) and Transcranial color-coded duplex sonography (TCCS) play an important part in neurocritical monitoring systems. Currently there are studies using flow velocities and pulsatility index (PI) to predict intracranial pressure (ICP) and clinical outcome. But the use of B-mode in such prediction is not yet investigated. The purposes of this study are to establish the correlation among clinical data, CT findings and information collected by TCCS, and to predict ICP and neurological outcome using such information. The focus would be on 3rd ventricle size, midline shift and anteroposterior-transverse ration of midbrain (midbrain index) obtained by B-mode of TCCS. This study is a prospective clinical study targeting on 30 neurocritical patients admitted to intensive care units in one year. The timing of performance of TCCS will be (1) within 6 hours after admission, (2) within 6 hours after each CT examination, and (3) when ICP is higher than 20 mmHg for more than 5 minutes. Glasgow coma scale (GCS), heart rate, blood pressure (systolic, diastolic, and mean), body temperature, central venous pressure (CVP), brain temperature, ICP, cerebral perfusion pressure (CPP), mean velocity (MV) of bilateral middle cerebral arteries (MCAs), PI, midline shift, 3rd ventricular dimension, anteroposterior to transverse ratio of midbrain (midbrain index, MI) are recorded. The latter three parameters are also obtained from CT scans, and compared with those obtained from TCCS. Outcome is evaluated with extended Glasgow outcome scale (GOSE), and analyzed with previous records. This study is going to prove that TCCS is a safe, convenient, real-time and cheap tool in clinical care for neurocritical patients. It also provides prediction of ICP and clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* Aged 16 to 80 years
* Neurocritical patient (head injury, hemorrhagic or ischemic stroke, subarachnoid hemorrhage, etc.) who was admitted to intensive care unit and had undergone intracranial pressure monitoring

Exclusion Criteria:

* associated with multiple organ impairment or failure
* single organ failure prior to neurocritical condition, such as cardiac, hepatic, or renal failure
* associated with severe infection or sepsis
Bortezomib for Treating Glomerular Diseases

Bortezomib is a proteasome inhibitor that inhibits autoantibody production, and reduces podocyte damage and mesangial hyperplasia caused by NF-κB activation in the kidney. Literature has reported that bortezomib can achieve a complete response rate of up to 38% in the treatment of glomerular diseases, but its safety and effectiveness remain to be assessed for the Chinese demographic. This study attempts to explore a new treatment plan for glomerular disease by observing the therapeutic effect of bortezomib on glomerular disease.


Eligibility Criteria:
Inclusion Criteria:

* Glomerular diseases confirmed by renal biopsy (including IgA nephropathy, membranous nephropathy, FSGS, etc.)
* Aged 18-65, male or female
* Signed informed consent
* 24h proteinuria \>1.5g/24h
* Glomerular filtration rate (eGFR) \>30ml/min/1.73m2 (calculated according to CKD-EPI formula) within 14 days before enrollment.
* Blood pressure \<140/90mmHg after drug treatment
* Unless there are contraindications, subjects must take a steady dose of ACEI and/or ARB for at least 4 weeks before screening

Exclusion Criteria:

* Renal pathology: glomerulosclerosis ratio \>70%, interstitial fibrosis \> severe
* Received immunosuppressant treatment within the past 6 months
* Inability to tolerate bortezomib
* Platelet count \< 30×109/L within 14 days before enrollment
* Neutrophil count \< 1.0×109/L within 14 days before enrollment
* Subjects had \>grade 2 peripheral neuropathy within 14 days before enrollment
* ECG evidence of myocardial infarction or NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia, or acute ischemia or active conduction system abnormalities within 6 months before enrollment
* Abnormal liver function such as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>=3 times normal upper limit (ULN), total bilirubin \>= 2 times ULN
* Newly diagnosed malignant tumor (within 5 years) or undergoing radiotherapy/chemotherapy
* Women who are pregnant or breast-feeding, or women of childbearing age who cannot guarantee effective contraception
* New serious life-threatening infections
* Active infectious diseases such as active tuberculosis, active viral hepatitis, HIV infection.
* Mental disorders and psychotropic drug uses
* Patients with an estimated life expectancy of fewer than 12 months
* Patients that were difficult to follow up on or had poor compliance
* Patients who do not wish to sign the form of informed consent
Influence of the COvid-19 Epidemic on STRESS

The Coronavirus has a major influence on stress for the general population. However, data are currently non-existent concerning the perception and knowledge of the epidemic, the feeling of information from companies / establishments / governments, the means of protection used, the feelings of fear generated and their impact on feelings of stigmatization towards certain ethnic groups or categories of patients (those who cough ...), or relationships with socio-demographic factors or lifestyle.

This is an observational study using a REDCap® questionnaire via an internet link, which will be distributed by any means (Facebook, Twitter, institution mailing lists via a referent, flash codes distributed to patients and the public, etc.).

The self-questionnaire will assess stress, perception and knowledge of the epidemic, the feeling of information on the part of businesses / establishments / governments, the means of protection used the feelings of fear generated and their impact on feelings of stigmatization towards certain ethnic groups or categories of patients (those who cough ...), or relationships with socio-demographic factors or lifestyle.

Eligibility Criteria:
Inclusion Criteria:

* Anyone volunteer to participate

Exclusion Criteria:

* Anyone non-voluntary to participate
Role of Overjet and Trauma in Libyan Children

Traumatic dental injuries are one of the commonly encountered dental emergencies. Missing anterior tooth in children due to any injury can be a source of considerable physical and psychological discomfort for the child. These consequences also have significant impact on parents, who are generally concerned with esthetic and economic aspects of this problem. It varies from small crack in the enamel to complete loss of the tooth. Injury to children teeth can be both painful and traumatic to the children

Traumatic injuries to anterior teeth have reported by several investigators. In Asia and Africa, the prevalence of TDI to anterior teeth among adolescents ranges from 4% to 35% and 15% to 21%, respectively and in America and Europe, the prevalence varied from 15% to 23% and 23% to 35%, respectively . 50% of school children have sustained traumatic injuries prior to graduation . A contributing factors make children susceptible to injuries have been widely investigated. These factors included Class-II, div.1 malocclusion, increased overjet . 71% to 92% of all injuries sustained in a lifetime occur before the age of 19 years, which occur at home, followed by school and public places.The aim of this study is to assess the mean overjet value in Libyan children and to examine the relationship between increased overjet and trauma to permanent incisor teeth

Eligibility Criteria:
Inclusion Criteria:

* Libyan children.
* The permanent incisors are present \& sufficiently erupted.

Exclusion Criteria:

* Non Libyan children.
* The permanent incisors are absent, or un-sufficiently erupted.
Evaluation of Women's Experience With EVRA (Norelgestromin + Ethinyl Estradiol) Transdermal Contraceptive Patch Compared With Previous Methods of Contraception.

The purpose of the study is to evaluate user experience with the EVRAÂ® Contraceptive Transdermal Patch; specifically, user satisfaction with the EVRAÂ® Patch, and if applicable, user preference of the EVRAÂ® Patch compared with the previous method of contraception. The study also evaluates contraceptive efficacy, safety and user compliance.

EVRA is the first transdermal contraceptive patch to receive approval by Health Canada and Marketing Authorization throughout the European Union. This is an open-label, single-arm, multicenter clinical study with a treatment duration of 24 weeks (6 treatment cycles of 4 weeks). Four clinic visits are scheduled: a screening Visit 1, in which subjects are asked to complete a set of questions about satisfaction with the current method of contraception, and questions about overall health status. Visits 2, 3, and 4 follow after Cycles 1, 3, and 6, respectively of EVRA treatment. At Visits 3 and 4, the subjects are asked to answer questions about satisfaction with EVRA, and about overall health status. At Visit 4 (final study visit) the subjects are asked to compare EVRA with previously used contraceptive methods. Compliance is assessed at all visits by returned boxes of study medication and a review of Diary Cards where subjects recorded the dates and sites of patch application, and details of any patch detachment. The study will generate the first large-scale, European dataset on women's experience with EVRA, including satisfaction, safety, efficacy, and compliance. These data will be compared with subjects' experience with previously used methods of contraception. Each EVRA patch, containing 6 mg NGMN and 600 ug EE, and delivering 150 microgram NGMN and 20 ug EE over 24 hours for 7 days, is worn for 1 week and replaced for 3 consecutive weeks. The fourth week is patch-free. Subjects can wear EVRA on 1 of 4 areas: buttock, abdomen, upper torso, or upper arm.

Eligibility Criteria:
Inclusion Criteria:

* Regular menstrual cycles
* sexually active and at risk of pregnancy
* nonpregnant
* normal Pap smear

Exclusion Criteria:

* Presently have or at risk of venous thrombosis or arterial thrombosis
* migraines with focal aura
* severe hypertension
* diabetes mellitus
* hereditary dyslipoproteinemia
* carcinoma of breast, endometrium or other estrogen-dependent neoplasia
* substance abuse
* skin conditions
* concurrent use of hormone-containing medication
* smoking women over 35 years of age.
Cross-cultural Adaptation, Reliability and Validity of the Turkish Version of the Headache Impact Questionnaire

The purpose of this study was to investigate cultural adaptation, reliability and validity of the Turkish version of the Headache Impact Questionnaire (HIQ).

The episodic nature of migraine attacks presents a number of difficulties in characterizing disease severity. There are differences in the severity, frequency and intensity of attacks and the general effect of the disease in individuals. Information about any particular attack is not sufficient to characterize the overall severity of the disease. Accordingly, the Headache Impact Questionnaire (HIQ) was developed to evaluate the headache experience over a period of time instead of any headache. Developed to measure the impact and quality of life of individuals suffering from headache, hıq evaluates the frequency and duration of headache, the degree of pain severity, daily life activities, disruptions in work or school life, the influence of the individual's leisure activities and other symptoms that may occur. HIQ consists of 16 items and the higher the score shows the seriousness of the impact. The study is planned with 80 individuals with complaint of headache. After questioning the sociodemographic characteristics of the individuals, the patients will be asked to fill in HIQ, Migraine Disability Assessment Questionnaire, Headache Impact Test-6 and Short Form-36.Test-retest will be re-applied to those of the same individuals who can be reached after 1 week. The results will be analyzed using the SPSS version 22.0 computer package program.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with any type of headache,
* Have a chronic headache.

Exclusion Criteria:

* Having a cognitive and neurological disorders.
Safety and Efficacy of Optive in Contact Lens Wearers With Dry Eyes

The purpose of this study is to determine if Optive®eye drops are safe for people who wear contact lenses and have dry eyes. The second goal of the study is to determine if using Optive®eye drops can improve my dry eye scores on a standard dry eye test (called the OSDI).


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 and over

  * Self-reported use of daily-wear soft contact lenses that have been a proper fit for at least one month prior to the screening visit.
  * Complaint of dry eyes
  * OSDI score \> 23

Exclusion Criteria:

* Use of RGP or PMMA contact lenses

  * Poorly fitting contact lenses
  * Concurrent ocular conditions or pathology that could affect contact lens fit or patient's ability to complete study
  * Concurrent use of topical medications other than study medications
  * Use of systemic medications with ocular drying sequelae:

    * Antihistamines
    * Decongestants
    * Antispasmotics Antidepressants Change in contact lens care solutions within the prior 30 days
Accuracy and Reproducibility of Virtually Guided Minimally Invasive Tooth Preparations Using Reverse Engineering

The aim of the study is to assess and reproduce standardized virtually guided minimally invasive tooth preparations using digitally designed occlusal template, compared to its reference virtual preparation using a computer aided 3-dimensional (3-D) analysis, and to investigate the effect of these preparations on absolute marginal discrepancy of 3 unit monolithic translucent zirconia FPD using a computer aided 3-D analysis.

Ten patients with missing mandibular first molar will receive a three-unit full contour monolithic zirconia FPD. Each patient case will receive two modes of preparation as in the previous in-vitro study: virtually guided tooth preparation using occlusal resin template to assist the intraoral preparation and the reference virtual tooth preparation. Each participant's preparation will be evaluated using diagnostic dental software and will be compared to a reference digital virtual preparation using 3-D mesh processing reverse engineering metrology software.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a missing lower first mandibular molar.
* Good oral hygiene with no signs of periapical pathology or periodontal disease (periodontal screening index 0-1) and with compliance to perform strict oral hygiene measures.
* Well-aligned abutment teeth with similar mesio-distal (M-D) and bucco-lingual (B- L) dimensions; (2nd premolar: M-D 7.8 mm ±1, B-L 8.7 mm ±1), (2nd molar: M-D 10.73±1, B-L 10.5 mm ±1).
* Abutment teeth with an adequate occluso-gingival height where (2nd premolar: 8.4 mm ±1, 2nd molar 7mm ±1), and adequate edentulous span length (9.5 mm±1); for an appropriate connector area of at least 9 mm.
* Absence of parafunctional habits (clinching, bruxism).

Exclusion Criteria:

* Bad oral hygiene.
* Advanced periodontitis, gingivitis, or recession.
* Abutments with subgingival restorations, root caries.
* Parafunctional habits.
* Undergoing orthodontic treatment.
* Obvious dentition malalignment.
A Study of Participants With Non-Valvular Atrial Fibrillation (NVAF) Treated or Untreated With Oral Anticoagulant in the National Cerebral and Cardiovascular Center (NCVC) in Japan

The purpose of this observational study is to understand real-world oral anticoagulants (OAC) (warfarin, apixaban, dabigatran, edoxaban and rivaroxaban) usage for non-valvular atrial fibrillation (NVAF) patients.


Eligibility Criteria:
Inclusion Criteria:

• Participants received medical treatment for NVAF between 10-Jan-2012 and 31-Aug-2020.

Exclusion Criteria:

* Had no data of serum creatinine in the participant's medical records
* Had no data of body weight in the participant's medical records
* Were given oral anticoagulant (OAC) for treatment of diseases other than atrial fibrillation (AF)

Other protocol-defined inclusion/exclusion criteria apply.
Flexor Tendon Injury Rehabilitation Regime Study

Hand flexor tendons bend the fingers down towards the palm, and can be cut during a sharp penetrating injury (e.g. from a knife or saw). Damaged flexor tendons are repaired surgically with sutures (stitches). After repair, a splint is applied to the fingers, hand and wrist for six to twelve weeks to protect the repair while the tendon heals and regains its normal strength.

Most rehabilitation protocols use a splint in which the wrist position is kept straight (neutral) or bent (flexed). Some groups have described splinting with the wrist cocked back (extended) and have made the argument that this may improve outcomes, as experimental data suggests that splinting the hand with the wrist extended increases the range of movement of the repaired flexor tendon (excursion), and therefore reduces the chance of the tendon sticking down to the surrounding tissues (adhesion). Previous studies have shown no adverse effects from splinting hands with the wrist extended, and no evidence tells us which wrist splint position is better (a state of clinical equipoise or apparently equivalent outcomes). This randomised trial aims to produce this evidence, and therefore improve functional outcomes for patients in future.

We propose to carry out a study to compare the outcomes (grip strength and range of movement) of flexor tendon repair in two groups of patients: one with wrists splinted in a neutral position and the other splinted in an extended position during their postoperative rehabilitation. No changes will be made to patient assessment and management,the surgery undertaken and the rehabilitation regime other than those to splint position. Previous work suggests that both positions are safe and effective. Informed consent will be obtained from all patients enrolled in the trial, and we aim to find out if the extended splint position produces better functional results.


Eligibility Criteria:
Inclusion Criteria:

* Primary inclusion criteria for the study is patients who have had 100% division by sharp laceration to the Flexor Digitorum Profundus (FDP+)/Flexor Digitorum Superficialis (FDS) within zone I or II and who have undergone repair with cruciate and epitendinous suture. Patients with multiple digit involvement will be included in the study.
* All repairs performed with 3/0 prolene suture cruciate repair and 6/0 prolene for the epitendinous repair as per departmental protocol.
* Patients with digital nerve repair along with the above injury will be included in the study

Exclusion Criteria:

* Patients with associated phalangeal fractures, skin and soft tissue loss or who had vascular compromise will be excluded from the study.
* Patients with tendon repairs other than cruciate will be excluded from the study
A Study on Disease Awareness and Treatment Compliance of Heart Failure Patients

The AWARENESS HF-PD is a cross-sectional, multicenter, survey-based study. Cases who were admitted to the outpatient clinic and hospitalized with the diagnosis of Heart Failure (Acute and Chronic) will be included in the study.

Data entry personnel to be assigned at the centers throughout the study will apply a questionnaire consisting of different questions to patients referred to them by clinicians with the diagnosis of HF. In addition, clinical features of HF from the current file of the cases (NYHA, comorbid conditions, comorbid diseases, blood pressure, heart rate, latest biochemistry (BNP/NTproBNP if available), hematology test results, most recent ECG, most recent echocardiography , coronary angiography report, if any) will be recorded. No additional examination/procedure will be performed for the study, only the data of the examinations requested by the clinician in routine clinical practice will be entered. A total of 200 patients from 3 centers will be included in this study over a six-month period.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged 18 and over
2. Patients diagnosed with acute or chronic heart failure
3. Patients who agreed to participate in the study

Exclusion Criteria:

1. Patients who stated that they did not agree to participate in the study
2. Patients who were not diagnosed with Heart Failure or whose diagnosis was changed or not confirmed during the index application
3. Pregnancy
Comparison of Nipple-areolar Complex Sensation According to Incision Types in Nipple-sparing Mastectomy

This study aims to assess nipple areolar complex sensation after nipple sparing mastectomy and compare the results according to different incisional approaches; specifically, inframammary fold (IMF) versus peri-areolar/radial. One-hundred-and-five post NSM patients from Oct 2019 to Nov 2021 have been recruited prospectively and evaluated for NAC sensory. A total of 97 patients (IMF 65 and peri-areolar/radial 32) were included in the analyses for comparison during follow up from 24 to 48 months after surgery. It was hypothesized that patients with IMF would have better outcomes for NAC senroy.


Eligibility Criteria:
Inclusion Criteria:

1. Females who are older than 18
2. Patients who underwent nipple sparing mastectomy in Gangnam Severance Hospital

Exclusion Criteria:

1. Loss or excision of NAC due to post-surgical necrosis
2. Diagnosis of other conditions that may interfere with cutaneous sensation