cyrilzakka/clinical-trials huggingface dataset:
Global Haemostatic Methods Following Administration of Bypassing Agents to Patients With Haemophilia With Inhibitors

Background

The treatment of haemophilia A and B has been revolutionized by the use of factor concentrate, both as prophylaxis and to treat bleeding episodes (on-demand treatment). However, despite its advantages, repeated treatment with factor concentrate can lead to development of inhibitors (antibodies) towards the coagulation factor in the concentrate. Another patient group in which the bleeding symptoms are difficult to treat because of inhibitors towards coagulation factors, most commonly FVIII, is patients with acquired haemophilia. Patients with high antibody titers exhibit a deficient or no response to factor concentrates and usually need treatment with bypassing agents, namely factor eight inhibitor bypassing agent (FEIBA®, Baxter) och recombinant activated factor VII (rFVIIa, Novo-Seven®, Novo Nordisk). The effect of the treatment cannot be accurately monitored by traditional coagulation tests.

The aim of the study is to evaluate the utility of the global haemostatic methods in patients with haemophilia with inhibitors. The objective is to improve the monitoring of the treatment effect and thus increase the safety of the patient and the effectiveness of the treatment.

Patients and methods

Patients

The primary cohort will consist of fifteen patients with inherited haemophilia with inhibitors as well as five adult patients with acquired haemophilia who are followed up at the Coagulation Department of the Karolinska University Hospital, Stockholm, Sweden.

Blood samples will be collected from those patients at specific time points (see Design of the study) during the course of two years (for each patient). The treatment (type, dose, duration) will be determined by the treating physician.

Methods (selection)

* Thrombin generation (Calibrated Automated Thrombogram, CAT® and a commercial kit from Siemens®).
* Overall haemostatic potential (OHP)

Design of the study

Timeframe for blood sampling: i) baseline (inclusion in the study), and ii) prior and after administration of bypassing agents to either treat bleeding symptoms or before an invasive procedure or as prophylaxis.

Data analysis

The variations in coagulation markers measured as described above (Methods) will be associated to the clinical symptoms (bleeding), the level of coagulation factors (if measurable) and the titers of the inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* informed consent
* meets the study population description

Exclusion Criteria:

* no informed consent age\<7 years
Corpectomy With Pyramesh Titanium Cage Reconstruction in Dorsolumber Metastatic Lesions

The vertebral column represents the most common bony site for metastasis with an incidence ranged from 30% to 70% in patients with metastatic neoplasms. The dorsal spine carries the highest frequent site for metastasis all over the vertebral column followed by the lumber spine. These metastatic lesions are clinical entities that often necessitate a complex spinal decompression and anterior reconstruction. Posterolateral approaches alone allow for excellent decompression with transpedicular fixation and safe visualization of the neural elements for corpectomy and reconstruction so the investigators can avoid the complications that can be happened with the staged surgery.

Purpose: investigators' aim in the study is to report cases and evaluate investigators' approach for fixation and assess the postoperative period regarding pain improvement and neurological deficit.

At neurosurgery department in Sohag faculty of medicine, Between August 2014 and August 2017, 26 patients with single dorsolumbar metastatic spinal lesions with vertebral body collapse underwent a single-stage, circumferential corpectomy and anterior spinal reconstruction with a pyramesh titanium cage via a midline, posterior and lateral approach. Investigators included in the study patients with retropulsed fragment inside the canal that causes spinal cord compression with neurological manifestation. Metastatic work up was done for cases. Exclusion criteria include patients with more than one spinal metastases or extra-spinal metastasis, patients with other comorbidities as cardiac ill patients, patients with chronic renal failure and patients who received radiotherapy or chemotherapy within one year before surgery. A preoperative neurological assessment, full laboratory investigations were done. Investigators used the Quebec scale to assess the patients' improvement regarding pain, and muscle power scale to evaluate the motor.

Eligibility Criteria:
Inclusion Criteria:

* patients with retropulsed fragment inside the canal that causes spinal cord compression with neurological manifestation.

Exclusion Criteria:

* patients with more than one spinal metastases or extra-spinal metastasis.
* patients with other comorbidities as cardiac ill patients, patients with chronic renal failure.
* patients who received radiotherapy or chemotherapy within one year before surgery.
Safety and Efficacy Therapy of Gemcitabine and Erbitux® to R0 or R1 Resected Pancreatic Cancer

This is an open-label, non-randomized Phase II study to evaluate immunochemotherapy in patients with R0 OR R1-resected pancreatic cancer.

Available study data indicated a possible benefit from adjuvant chemotherapy for patients with resected pancreatic cancer. The optimal therapy regimen has yet to be determined.

Based on the experiences with cetuximab (Erbitux®)and gemcitabine in advanced pancreatic cancer and with gemcitabine as adjuvant therapy, the aim of this study was to evaluate the feasibility of the combined treatment of cetuximab and gemcitabine in patients with R0 or R1-resectable pancreatic cancer and to evaluate if the disease free survival can be increased by the addition of an EGFR-targeted therapy.

Eligibility Criteria:
Inclusion Criteria:

* Provided signed written informed consent.
* Men and woman age \> 18 years
* Histologically confirmed R0 OR R1 resected ductal adenocarcinoma of the pancreas
* Life expectancy \>12 weeks
* Patients with performance status of ECOG ≤ 2
* Patients without metastasis

Exclusion Criteria:

* Women of child bearing potential (WOCP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and follow-up to 4 weeks after the study.
* Women who are pregnant or breastfeeding.
* Women with a positive pregnancy test on enrollment or prior to study drug administration.
* Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
* Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for \> 5 years will be allowed to enter the trial).
* Inadequate hematologic function defined by an absolute neutrophils count (ANC) \< 1,500/mm³, a platelet count \< 100,000/mm³ and a hemoglobin \< 9 g/dL.
* Inadequate hepatic function defined by the upper limit of normal (ULN), AST and ALT levels \> 5 times the ULN.
* Serum bilirubin \> 1.5 times the ULN.
* Inadequate renal function defined by a serum creatinine \> 1.5 times the ULN.
* Prior cetuximab or other therapy that targets the EGF pathway.
* Prior antibody therapy.
* Any known allergic reaction against cetuximab.
* Any concurrent chronic systemic immune therapy, radiation therapy, hormonal therapy (except for physiological replacement), or any other investigational agents.
* HIV infection.
* Having participated in another clinical trial in the preceding 30 days.
Immunolocalization of 1,25,Dihydroxyvitamin D3 in Aggressive Periodontitis Patients

The study was to intended to visualize the nuclear localization of vitamin D receptor in oral tissues of aggressive periodontitis patients to better understand the potential for receptor in disease activity or progression.

Aggressive periodontitis (AgP) is an infectious disease of the periodontium which affects young adults, causing damage to the supporting apparatus of the teeth, leading to rapid bone resorption and tooth loss. Its clinical features have been shown to result from several genetic and environmental factors.

This has increased the interest to research those genetic host factors as they may provide useful risk markers, reveal important information regarding the pathogenesis and also identification of effective preventive agents that might help decrease the disease burden.

1,25-dihydroxyvitamin D3,apart from these traditional calcium-related actions, this active form is being increasingly recognized for its potent anti-proliferative, anti-differentiative and immunomodulatory activities.

The calcitriol activity is largely mediated by the vitamin D receptor (VDR) whose expression has been described in some tissues. VDR is localized in both the cytosol and nucleus and accumulates in the nucleus in response to 1,25,dihydroxyvitamin D3 binding.

Expression and nuclear activation of the VDR are necessary for the effects of vitamin D. Thus, alterations in the vitamin D pathway lead to disturbances in mineral metabolism. It may be hypothesized that the rapid bone loss which occurs in aggressive periodontitis patients may be due to decreased or absence of expression of Vitamin D receptor in the nucleus.

Eligibility Criteria:
Inclusion Criteria:

1. Generalized Aggressive periodontitis patients were onset of periodontal disease at \<35yrs of age and atleast eight teeth with probing depth \>6mm and radiographic evidence of alveolar bone loss, three of which were not first molar or incisor under test group.
2. Control group includes systemically and periodontally healthy individuals who is of same age as that of test group.

   -

Exclusion Criteria

1. Subjects taking drugs for vitamin D or calcium
2. Subjects received periodontal therapy within previous year
3. Pregnant subjects
4. Smokers
5. Patients with systemic diseases -
Anesthesia in PROstate Biopsy Pain Obstruction Study

This is a multicentre randomized controlled trial in comparison of the perineal nerve block approach between the periprostatic block in the pain control in men undergo a transperineal prostate biopsy.

This trial is a prospective, multicentre, randomized controlled study in which all men plan to undergo a transperineal prostate biopsy. This study aims to determine whether the perineal nerve block approach is better than the periprostatic block in the pain control in men undergo a transperineal prostate biopsy.

Eligibility Criteria:
Inclusion Criteria:

1. age between 18 and 80 years old
2. a PSA level of 4 - 20 ng/ml, and/or suspicious rectal examination findings;
3. fully understand the clinical trial protocol and sign the informed consent;

Exclusion Criteria:

1. local anesthetic allergy patients;
2. symptomatic acute or chronic inflammation of the prostate;
3. cannot tolerate prostate biopsy or has contraindication to biopsy;
4. patients judged by the investigator to be unsuitable to participate in the clinical trial;
The Effect of Vitamin D3 on Postoperative Pain in Patients Undergoing Craniotomy

Vitamin D is a hormone mainly synthesized in the skin in the presence of sunlight. Like other hormones, vitamin D plays a role in a wide range of processes in the body. Some studies have shown vitamin D has anti-inflammatory effects in the body by reducing the release of pro-inflammatory cytokines and suppressing T-cell responses. Therefore, vitamin D may be effective on reduce pain by such mechanisms. In this trial patients with brain tumor under craniotomy will receive a single high dose vitamin D compared to the control group.

A randomized, double blind, controlled trial will be conducted in intensive care unit (ICU) and neurosurgery ward, in Shohada-E-Tajrish hospital,Tehran, Iran. First, patients will be carefully checked for inclusion and exclusion criteria. Then, the eligible patients will complete the consent form for this study. 60 eligible brain tumor patients diagnosed by surgeon that are ready for craniotomy will be selected.These patients will be divided into two groups. Intervention group will be received an intramuscular (IM) single dose of vitamin D (300000 IU),while another group will not receive. Pain in patients will be checked daily by up to 3 days after surgery. Finally, the VAS pain score will be compared in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent of patient or legal representative
* 25(OH)D level below 20ng/dL

Exclusion Criteria:

* Other trial participation, including previous participation in the pilot trial
* Pregnant or lactating women
* Hypercalcemia
* Hyperphosphatemia
* Tuberculosis
* Sarcoidosis
* History of nephrolithiasis
* History of hyperparathyroidism
* Medications that interfere with vitamin D metabolism
* Renal Insufficiency
Therapeutic Effect of Direct Current Stimulation on Cognitive Function of Mild to Moderate Alzheimer Patients

The current study is planed to compare the efficacy of real (anodal and cathodal) vs sham transcranial direct current stimulation (tDCS) applied over the left dorsolateral prefrontal cortex (DLPFC) on cognitive functions and cortical excitability of patients with Alzheimer disease (AD).

Thirty three with mild to moderate Alzheimer's disease (AD) patients (diagnosis of probable AD according to the criteria of the National Institute of Neurological and Communicative Disorders and Stroke Alzheimer Disease and Related Disorders Association \[NINCDS-ADRDA\] were included in this study) were randomly classified into one of three groups (eleven for each group). The first group received anodal tDCS over left DLPFC and 2rd group received cathodal tDCS on the left DLPFC and the 3rd group received sham tDCS stimulation, daily for 10 consecutive days (5 days/week for 2 weeks). Minimental State Examination (MMSE), psychometric assessment for cognitive functions (MMSE, Wechsler memory scale, Wechsler adult Intelligent scale) were assessed before, after 10th sessions, and then after 1 and 2 month. Cortical excitability was assessed in both hemispheres before and after the end of sessions. Neurophysiological evaluations included resting and active motor threshold (rMT and aMT), and cortical silent period (CSP).

At the time of recruitment, none of the patients taking antidepressants, or neuroleptic, sedative-hypnotic drugs for at least two weeks before the assessment. All participants or their caregivers will give informed consent before participation in the test and after full explanation of the study protocol.

Outcome: The real group received (anodal and cathodal) tDCS are expected to have more improvement on cognitive functions compared to sham tDCS group. tDCS is considered new adjuvant non pharmacological therapeutic tool for management of AD patients with mild to moderate degree dementia.


Eligibility Criteria:
Inclusion Criteria:

* Thirty patients with a diagnosis of probable AD according to the criteria of the National Institute of Neurological and Communicative Disorders Association (NINCDS-ADRDA) (McKhann G et al.,1994) will be included in this study.

Exclusion Criteria:

* previous history of stroke
* Metabolic disturbances
* Other major medical illness or epilepsy
* Patients metallic objects in the body
* Patients subjected to a craniotomy in the past.
Epipericardial Fat Necrosis: A Misdiagnosed Condition

Epipericardial fat necrosis is a benign and self-limited condition that mainly curses with acute pleuritic chest pain and therefore must be an important differential diagnosis for patients in emergency department (ED). The knowledge of characteristics symptoms and correct management may avoid misdiagnosis or mistakes with other severe conditions like pulmonary embolism, pericarditis or acute coronary disease.

Despite the importance of this entity, only fewer than 40 cases have been reported since 1957, when the condition was first described.

We have seen a couple of similar cases in our institution during a short period of time, and we suspect that these numbers doesn't mean the real prevalence of epipericardial fat necrosis, so maybe this condition could be underdiagnosed. Instead, there isn't a study that tried to estimate an incidence of this entity.


Eligibility Criteria:
Inclusion Criteria:

* patients with imaging criteria of EFN (defined as a round fat attenuation lesion with peripheral stranding located in the epipericardial fat)

Exclusion Criteria:

* no exclusion criteria
Prognostic Study of Gastric MALT Lymphoma After Eradication of Helicobacter Pylori

To survey the grade of gastric MALT lymphoma after eradication of Helicobacter pylori


Eligibility Criteria:
Inclusion criteria:

* gastric low-grade mucosa-associated lymphoid tissue (MALT) lymphoma with Helicobacter pylori positive
* The stages of MALT lymphoma are Lugano International Conference classification Stage I or II 1 and Wotherspoon grade 4 or 5

Exclusion criteria:

* With diffuse large B-cell lymphoma
* Have been treated to gastric mucosa-associated lymphoid tissue (MALT) lymphoma
* Corresponding to contraindication of each drug
Clinical Safety and Efficacy of CT ASPHINA 509 Lenses

Clinical safety and efficacy of CT ASPHINA 509 IOLs after implantation


Eligibility Criteria:
Inclusion Criteria:

Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;

* Patients of any gender
* Assured follow-up examinations
* Biometry measurement preferably compatible with the IOLMaster evaluation;
* IOL implanted into the capsular bag with IOL model CT ASPHINA 409MP (UVE material) in one eye with at least 12 months follow up at the time of the postop visit
* Patients who had uncomplicated (no peroperative complication) agedrelated cataract surgery in a healthy eye (beside clinically significant cataract)

Exclusion Criteria:

* • BCVA not available preoperatively or better than 0.3 logMAR pre-op

  * Patients unable to meet the limitations of the protocol or likely of noncooperation during the trial
  * Patients whose freedom is impaired by administrative or legal order
  * Concurrent participation in another drug or device investigation
Narrow Band Imaging (NBI) Under Electronic Bronchoscope in Lung Cancer

Narrow-Band Imaging (NBI) is useful to better demarcate the superficial extent of central type of lung cancer, but its sensitivity and specificity in clinical practice were little studied. This study aimed to investigate the diagnostic effects of NBI in suspected patients with central lung cancer and its application in staging diagnosis of central lung cancer.

With high morbidity and mortality, lung cancer is one of the most common tumors in the world. Therefore, early detection, accurate diagnosis and staging division can effectively guide clinical interventions, thereby improving patient survival. Narrowband imaging under electronic bronchoscope (NBI) is an emerging optical image emphasis technology that can enhance the contrast between the mucosal surface and underlying blood vessels, specifically display the distribution of blood vessels, and highlight the subtle changes in mucosal structure. Meanwhile, it can reduce unnecessary biopsy with low risk and costs. In recent years, NBI technology has gradually begun to show its unique advantages in the diagnosis of gastric cancer, esophageal cancer, nasopharyngeal cancer, and bladder cancer. The purpose of this study is to explore the diagnostic value of NBI under electronic bronchoscopy for early detection and accurate diagnosis of lung cancer, and to provide a more economical, safer and more efficient diagnosis option for lung cancer patients.

Eligibility Criteria:
Inclusion Criteria:

- Patients had a history or current central lung cancer

Exclusion Criteria:

- NONE
Study Investigating Patient-Reported Outcomes in Lower-risk MDS Patients

PRO-RED is a prospective, longitudinal, and multicenter observational study. Enrolled patients will be followed for 6 months in at least monthly intervals in terms of their received red blood cell transfusions and routine myelodysplastic neoplasms (MDS)-associated clinical parameters. In addition, the participating subjects will be provided with a digital/mobile application covering a smartphone app or paper-based questionnaires to answer a set of quality of life (QoL) questions once a week. During routine visits in the clinical trials center performed by the treating physician (at least every month), patients will answer standardized questionnaires for the assessment of MDS-related QoL. Also, included patients will take a photo of fingernails/eyelids with their smartphone camera with the aim to further analyze these pictures in a way to potentially deduct correlated hemoglobin (Hb)-values. As a long term aim beyond the PRO-RED study, the data will serve as a training cohort for the development of an algorithm for image-based calculation of individual Hb levels.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Confirmed diagnosis of lower-risk myelodysplastic neoplasms (MDS; IPSS-R very low, low, intermediate up to 3.5 points) or MDS/MPN overlap including MDS/MPN-RS-T, MDS/MPNu, aCML or non-proliferative chronic myelomonocytic leukemia (CMML) according to World Health Organization (WHO) criteria as determined by microscopic and standard cytogenetic analyses of the bone marrow and peripheral complete blood count (CBC)
* Symptomatic transfusion dependent (TD) anemia defined as having received ≥3 units of red blood cells (RBC) within the last 16 weeks prior to screening according to the International Working Group (IWG) criteria for MDS (Platzbecker et al. 2019)

Exclusion Criteria:

- Suspected lack of compliance according to the investigator
Evaluating Accuracy of Breath Sound Recordings and STOP-Bang Screening For Obstructive Sleep Apnea While Awake

The investigators will perform a diagnostic accuracy study comparing tracheal breath sound recordings in awake individuals to the STOP-Bang screening questionnaire, using the apnea-hypopnea index (AHI) score determined by polysomnography as the gold standard.

Obstructive sleep apnea (OSA) is a breathing disorder with numerous health effects including a greater risk of peri-operative anesthetic complications. Numerous screening tools exist but are not without limitations. Diagnostic overnight sleep studies are resource-intensive and difficult to obtain in the short time period between pre-operative clinic assessment and the day of surgery.

This project aims to test the diagnostic performance of a new screening technology, Awake-OSA, for screening of obstructive sleep apnea (OSA). "Awake-OSA" uses a small external microphone placed on the neck, to record and analyze tracheal breath sounds at the bedside while the patient is awake.

Using polysomnography (PSG) as a gold standard, the investigators will compare Awake-OSA (breath sound recording) and the STOP-Bang screening questionnaire in their ability to accurately identify patients with OSA, as well as classify OSA in terms of severity.

Early, point-of-care diagnosis has the potential to provide a low-cost, convenient alternative to traditional screening questionnaires and enable more selective use of PSG. Our goal is to improve peri-operative patient safety while improving use of resources and streamlining patient care.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older.
* Referred for diagnostic sleep study.
* Willing and able to consent.

Exclusion Criteria:

* Under the age of 18 yrs.
* Unwilling or unable to give consent.
* Expected to have an abnormal EEG (epilepsy, brain tumour, deep brain stimulator).
* Significant craniofacial abnormality (ex. unrepaired cleft lip/palate).