cyrilzakka/clinical-trials huggingface dataset:
Post-marketing Safety Surveillance of Xueshuantong-Injection : a Registry Study

This registry aims to monitor the safety of Xueshuantong Injection and to identify the potential risk factors for the adverse drug reactions.

Xueshuantong-Injection is a kind of natural compound injection with Panax notoginseng saponins(PNS). It's a popular drug for improving blood circulation that focusing on central retinal vein occlusion, stroke sequela, internal ophthalmopathy, hyphema and so on. However, more and more case reports about the adverse drug events of Panax notoginseng saponins have been reported in recent years. Therefore, this registry of Xueshuantong-Injection aims to monitor the safety and find the incidence of adverse drug reactions to Xueshuantong-Injection. Moreover, this registry is highly concerned on identifying the potential risk factors for the adverse drug reactions.

Eligibility Criteria:
Inclusion Criteria:

* Patients who use Xueshuantong-Injection in the monitoring departments of certain hospitals

Exclusion Criteria:

* None
Feasibility Study of Deep Learning-based MDixon Quant for Quantitative Assessment of Chemotherapy-induced Fatty Liver

The purpose of this study is to quantitatively assess the changes in liver fat content in cancer patients before and after treatment.

The main questions it aims to answer are:How does the liver fat fraction change before and after chemotherapy? In this study, patients undergoing mDixon Quant scanning are subjected to fully automated segmentation and measurement of liver fat content using artificial intelligence.

Regarding the extraction of liver fat fraction, the traditional axial ROI method involves selecting several regions of interest (ROIs) at the largest cross-sectional level or across multiple continuous sections, and taking the average value as the whole-liver fat fraction. This method is complex, time-consuming, and cannot obtain the whole-liver fat fraction. In this study, a threshold extraction method is used to obtain the whole-liver fat fraction, enabling a 2D-to-3D conversion, which is more time-efficient and labor-saving, and provides a more accurate measurement.

Eligibility Criteria:
Inclusion Criteria:

1. CT/B ultrasound showed no fatty liver
2. No MRI contraindications, including pacemaker, stent, metal implant, or claustrophobia
3. Received neoadjuvant/adjuvant chemotherapy

Exclusion Criteria:

1. Missing follow-up information
2. Liver lesions (metastases, hemangioma, etc.)
3. Poor image quality
Efficacy Study of Neridronate to Treat Painful Osteoarthritis of the Knee With Bone Marrow Lesions.

The purpose of this study is to determine whether neridronate is effective in the treatment of pain related to bone marrow oedema in patients with osteoarthritis of the knee.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of knee Osteoarthritis (ACR criteria)
* Radiographic diagnosis of knee Osteoarthritis (Kellgren/Lawrence scale \>=2)
* \>4 weeks but \<3 months pain, reported as \>30 mm on a 100 mm VAS scale
* bone marrow oedema of the affected knee on magnetic resonance

Exclusion Criteria:

* inflammatory arthritis
* aseptic osteonecrosis of the knee
* previous or current treatment with Bisphosphonates
* serum calcium or creatinine abnormalities
Small Intestine Length Measurement Using 3D CT Volumetry and in Vivo Measurement Using Pre-marked Graspers in Revisional Bariatric Surgeries. a Comparative Study

Measuring bowel length during hypo-absorptive surgeries like Roux-en-Y gastric bypass (RYGB) and Single Anastomosis Duodeno-ileal Sleeve (SADI-s) is controversial and usually abandoned due to the high risk of intestinal injury. However, some surgeons, especially in revisional surgery, prefer to count the whole bowel length to avoid leaving very short segments and severe malnutrition afterwards.

3D reconstructed CT scan can be useful in such conditions, avoiding the risk of intestinal injury, but accurate measures might be doubtful.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are candidates for revisional bariatric surgery
* Patients consenting to participate in the study.

Exclusion Criteria:

* Patients with severe adhesions where measuring the small bowel may expose them to unnecessary injuries.
* Patients refusing to participate in the study.
* Patient refusing CT scan to be done pre-operatively.
High Dose of Activated Recombinant Human Factor VII for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of two dose schedules of activated recombinant human factor VII in treatment of joint bleeds in haemophilia patients with inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed of congenital haemophilia A or B with inhibitors to factor VIII or IX, respectively
* A history of 3 or more joint bleeds during the last 12 months

Exclusion Criteria:

* Joint bleeding within 7 days prior to trial start
* Treatment for bleeds within the last 5 days prior to trial start
* Clinically relevant coagulation disorders other than congenital haemophilia A or B
Assessment of the the ETView Double-lumen Tube

The double tube ETView is particularly innovative as it includes an integrated optical fiber to visualize the carena. This study aims to verify if if its use avoids the requirement of a fibreoptic bronchoscopy.


Eligibility Criteria:
Inclusion Criteria:

* elective thoracic surgery with anticipated use of a DLT

Exclusion Criteria:

* left pneumonectomy or left lobectomy requiring an anastomosis on the left main bronchus
* proximal left bronchial lesion
* anatomical abnormality of the bronchial tree
* suspicion of difficult mask ventilation or intubation
Comparative Study Matching Intraperitoneal Onlay Mesh (IPOM) and Sublay Mesh to Treat Umbilical Hernia

This study is designed to compare two techniques for operative care of umbilical hernia in adults regarding wound complications, wound side fluid collections, recurrence rate, postoperative pain, duration of hospitalization and quality of life. The IPOM technique provides mesh positioning directly into the abdominal cavity onto the defect under laparoscopic control while in sublay position the mesh is placed directly behind the rectus muscle after small incision close to the belly button.


Eligibility Criteria:
Inclusion Criteria:

* informed consent
* patient age: ≥ 18 years
* elective surgery for umbilical hernia
* hernia diameter ≥ 1cm

Exclusion Criteria:

* previous history of median laparotomy
* navel site infection
* contraindication for general anaesthesia
* American Society of Anesthesiologists (ASA) score \>IV
* pregnancy
* cirrhosis of the liver (CHILD B and C) and/or ascites
* cytostatic therapy
* incarcerated hernia
* recurrent hernia
Anti-Inflammatory Diet Effect in Rheumatoid Arthritis Patients

The current study pretends to clarify, whether or not a healthy anti inflammatory diet improves different health-related outcomes in participants with rheumatoid arthritis.

The current study pretends to clarify, whether or not a healthy anti-inflammatory diet improves different health-related outcomes: clinical, analytical, anthropometric and psychological outcomes in participants with rheumatoid arthritis. Due to the intervention has been based in a dietary advise, one of the goals of this study is also to evaluate the role of dietary advice in changing effectively the dietary patterns of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis patients

Exclusion Criteria:

Any additional pathology or situation that could be considered, according to clinical criteria, of risk for the patient or for the study. for example:

* Chronic renal failure
* Liver failure
* Heart failure
* Pregnancy
Efficacy of Modified Constraint-Induced Movement Therapy on the Upper Limb Function of Sub-acute Stroke Patients in Peshawar Pakistan

This RCT will also help the clinicians to provide the best treatment to their patients for better outcomes.

The objective of the study is to determine the efficacy of Modified Constraint-induced movement therapy on the Upper Limb function of Sub-acute stroke patients in Peshawar Pakistan.

Alternative Hypothesis: There will be a difference in the means of Modified Constraint-induced movement therapyand traditional physical therapy on the upper limb function of subacute stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age 30 to 60 years
* 2. Both female \& male will be included.
* 3. Cognitive and lingual ability to communicate with the research staff.
* 4. A minimum of 10 degrees of active finger extension and 20 degrees of active wrist extension(16).
* 5. A history of a single stroke resulting in a hemiparesis

Exclusion Criteria:

* 1. Recurrent stroke during the training period.
* 2. Neurological or orthopedic disorders prohibiting the use of the paretic arm.
* 3. Patients who doesn't show willingness to participate in the study.
Strategies to Prevent Pneumonia (SToP Pneumonia)

This study tests whether special oral care provided by nurses to critically ill patients who are on a breathing machine (mechanical ventilator) can help to reduce the build-up of dental plaque on the teeth and reduce the risk of pneumonia.

Pneumonia is the leading cause of death from hospital-acquired infections. Intubation and mechanical ventilation greatly increase the risk of bacterial ventilator associated pneumonia. Growth of potentially pathogenic bacteria in dental plaque of critically ill patients provides a nidus of infection for microorganisms that have been shown to be responsible for the development of Ventilator Associated Pneumonia. Since these organisms are concentrated in dental plaque, removal of organisms from the oral cavity by oral care interventions is a theoretically attractive method to reduce the risk of development of Ventilator Associated Pneumonia. However, evidence-based protocols for oral care of mechanically ventilated patients are not available. Results of the study have the potential to improve nursing care, and to positively affect patient well-being, morbidity, mortality, and health care costs.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older, admitted to one of four intensive care units at the study hospital, breathing tube in place, and on a breathing machine (mechanical ventilator)

Exclusion Criteria:

* Breathing tube in place for more than 24 hours prior to entry into the study, absence of teeth, or a medical diagnosis of pneumonia when the breathing tube is put in.
The Registry Study of Genetic Alterations of Melanoma in Taiwan

Cutaneous melanoma is the most aggressive malignancy in skin cancers. Cutaneous melanoma is a rare disease in Taiwan with an incidence rate of around 1/100,000. Acral lentiginous melanoma is the most common subtype and comprises more than half of cutaneous melanoma in Asia including Taiwan but only 1% in Caucasians. In addition, mucosal melanoma accounts for more than 20% of malignancy melanoma in Taiwan but only 1% in Caucasians. Acral and mucosal melanomas have distinct epidemiological, clinical, pathological and genetic features from non-acral melanoma which is commonly seen in Western countries. Comparing with melanoma in Caucasians, Asian melanoma has higher recurrence rate after primary surgery, lower response rate to immunotherapy, and shorter progression-free survival for immunotherapy and targeted therapy leading generally poor survival outcomes regardless stage.

Most melanoma patients present with locally advanced or metastatic disease at diagnosis reflecting the aggressive disease nature of melanoma in Taiwan. Currently, surgical resection of primary tumor and lymph node dissection are the main treatment for patients with locally advanced melanoma. Adjuvant therapy should be considered for stage III melanoma. Unfortunately, most patients recur after above aggressive treatment. Systemic treatment including targeted therapy, immunotherapy and chemotherapy is the main for unresectable or metastatic melanoma. The prognosis of these patients remains poor with a median survival time around a year. Therefore, a better understanding of this deadly disease is crucial and finding better therapeutic strategies for these patients and stratifying patients with suitable treatment are urgent.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old
2. Pathologically confirmed melanoma. (Patients with additional malignancies requiring treatment or follow-up are allowed. Only treatment for melanoma should be recorded).
3. ECOG performance status \< 3
4. Cohort 1(early acral melanoma): melanoma, stage I/II; Cohort 2 (locally advanced acral melanoma): melanoma, stage III, resectable; and Cohort 3 (advanced): unresectable / metastatic melanoma, stage III/IV or recurrent melanoma (unresectable). Staging is based on AJCC Cancer Staging System 8th edition). The patients with advanced melanoma with available comprehensive NGS report are included in cohort 4.
5. Willingness to provide archival or newly obtained tumor tissues for this study proposal
6. Life expectancy more than 3 months -
7. Patients fully understand the protocol with the willingness to have regular follow-up

Exclusion Criteria:

1. Inability to cooperate by providing a complete medical history
2. No available tumor tissues for genetic testing (archived tissue sampling more than 5 years from screening date)
3. Undesirable compliance (Mental status is not fit for further treatment or data collection.)
PFAS Exposure and Immune Response to Vaccination in Adults

This clinical trial aims to investigate how exposure to Perfluorononanoic acid (PFNA), a type of per- and polyfluoroalkyl substance (PFAS), affects the immune response to the standard tetanus and diphtheria (Td) vaccine. The study focuses on participants from a community with known prior PFNA exposure through contaminated drinking water. The main question it aims to answer is:

* Does exposure to PFNA weaken the body's initial immune response, leading to lower levels of protective antibodies after vaccination?

Participants will:

* Receive Tetanus and Diphtheria (Td) booster vaccination
* Visit the study office 7 times over a 30-day period
* Have blood and saliva collected at each study visit


Eligibility Criteria:
Inclusion Criteria:

* Participated in the Paulsboro PFAS Health Study
* Provided a blood sample for the Paulsboro PFAS Health Study
* Weigh at least 110 pounds

Exclusion Criteria:

* Currently Pregnant
* History of difficult blood draws
* History of adverse reaction to prior vaccinations
* Currently taking immune suppressants
* Recent dental surgery or dental procedure within 4 weeks of starting study
* Had a Td booster in the past 10 years
Intubation During Adult Intubation

The objective of this study is to compared effectiveness of intubation using ETView VivaSight SL and standard tracheal tube during resuscitation performed by a EMS-paramedics.


Eligibility Criteria:
Inclusion Criteria:

* Give voluntary consent to participate in the study
* minimum 1 year of work experience in emergency medicine
* experienced emergency medical personnel (physicians, nurses, paramedics)

Exclusion Criteria:

* Not meet the above criteria
* Wrist or Low back diseases
Risk-stratified Testing for Safe Removal of Penicillin Allergy Labels

The aim of this clinical trial is to analyze the negative predictive capacity and safety of risk-stratified direct drug provocation tests for patients with self-reported penicillin allergies. Patients reporting immediate or delayed penicillin allergies and defined as low-risk by the PEN-FAST score will receive drug provocation tests without prior skin testing.

The PEN-FAST clinical decision rule is an internationally validated scoring system (0-5 points) that identifies low-risk patients (= a score of 0-2 points) with self-reported penicillin allergies with a negative predictive value (NPV) of over 95%. Performing direct drug provocation tests without prior skin testing on these low-risk patients was shown to be non-inferior in terms of safety and prediction of immediate allergic reactions. However, several studies have questioned the negative predictive capacity of the PEN-FAST score. In these studies, misclassifications of the PEN-FAST score were mainly based on positive skin test findings that can show false-positive results.

This study aims to validate the NPV and safety of direct drug provocation tests using the PEN-FAST score.

Participants with a PEN-FAST score of 0-2 points will directly receive a two-dose challenge (50%-50%) or single challenge (100%) with the culprit penicillin and will be monitored for at least 4 hours. No skin tests will be performed prior to the drug provocation test. Patients will be instructed to contact the hospital after the drug provocation test to monitor any delayed allergic reactions.

The outcomes will be compared to those of patients with a PEN-FAST score of 0-2 points who do not wish to skip the skin tests and who will, in parallel, receive the standard-of-care testing.

Currently, this study is approved as a single-site study.

Eligibility Criteria:
Inclusion Criteria:

1. Adult outpatients or inpatients with a penicillin allergy label
2. Willing and able to give consent.
3. PEN-FAST score of 0-2 points

Exclusion Criteria:

1. Age \<18 years
2. Concurrent immunosuppressive therapy with 20 mg of prednisolone per day or steroid equivalent
3. Concurrent antihistamine therapy
4. Pregnancy
5. Significantly impaired general condition
6. Unstable or therapeutically inadequately controlled bronchial asthma
7. History of stem cell transplantation
8. History of acute interstitial nephritis
9. Chronic urticaria
10. Mastocytosis
Effect of TECAR in Treating Stress Urinary Incontinence

Stress urinary incontinence (SUI) is the defined as a leakage of urine with physical exertion, most commonly from coughing, laughing, or sneezing. It has a profound psychosocial impact not only to patients but also on their families and caregivers, resulting in loss of self stem, sexual dysfunction.Because of the higher incidence of stress urinary incontinence that reach 30% of women during childbearing period, 50% in elderly women, and its social embarrassing condition causing socio-psychological problems, disability and dependency with higher economic impact and based on TECAR therapy had better recovery of muscle strength and function in addition to there is no study has evaluated the impact of TECAR treatment on stress urinary incontinence, our study aim to assess the effectiveness of TECAR in treatment of such cases to decrease time of treatment and provide good results to patients.


Eligibility Criteria:
Inclusion Criteria:Participants aged between30 to 50 year and BMI not exceed 30 kg/cm2. All subjects complain from mild SUI due to hypermobility of bladder neck and weakness of pelvic floor exercise

-

Exclusion Criteria:

* Those with neurological diseases, diabetic neuropathy, congenital urologic disease, bladder cancer and neurogenic bladder, detrusor hyperactivity and bladder or urethra previous surgery
CardioQ vs Thermodilution Measurements of Cardiac Output

Minimal invasive monitoring systems of central hemodynamics are gaining increasing popularity. The present study investigates the precision of the esophageal doppler (CardioQ) derived cardiac output and its agreement with pulmonary artery catheter thermodilution (PAC TD) for measuring CO during steady state and with induced hemodynamic changes in patients scheduled for elective cardiac surgery.

Twenty-five patients are planned to be enrolled. After induction of anesthesia, insertion of the PAC and the esophageal-doppler probe, the patient are placed in the following successive positions: a) supine, b) head-down tilt, c) head-up tilt, d) supine, e) supine with phenylephrine administration f) pace heart rate 80 bpm, g) pace heart rate 110 bpm, and CO are measured simultaneously using the CardioQ and PAC TD.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for elective coronary artery bypass grafting (CABG), who are in stable sinus rhythm, who have a left ventricular ejection fraction \> 0.40 measured by transthoracic echocardiography, and who have no significant valve pathology

Exclusion Criteria:

-
Diagnostic Utility of Pleural Fluid MAGE Assay in Patients With Pleural Effusion From Primary Lung Cancer

Melanoma antigen (MAGE) gene is known to be expressed in tumor cells, testis and placenta. The purpose of this prospective study was to investigate the sensitivity, specificity and accuracy of pleural fluid MAGE gene expression, tumor marker and cytology in the diagnosis of malignant pleural effusion.


Eligibility Criteria:
Inclusion Criteria:

* unilateral pleural effusion on chest radiography

Exclusion Criteria:

* body temperature \> 38.3ºC and peripheral blood leukocytosis (\>12,000/μl)
Dose Ranging Study of SLIT Tablets of House Dust Mite Allergen Extracts (HDM) in Adults With HDM-associated Allergic Asthma

The purpose of this study is to investigate the efficacy and safety of different doses of sublingual tablets of house dust mite allergen extracts as compared to placebo in adults with house dust mite-associated allergic asthma.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Male or female from 18 to 50 years of age.
* Diagnosed asthma and rhinitis with medical history consistent with HDM-induced allergic asthma and rhinitis.
* Positive SPT to HDM and and HDM-specific IgE serum value ≥ 0.7 kU/L.
* Stable asthma therapies.
* Spirometry (pre-bronchodilator) with best FEV1 ≥ 70% of the predicted value.
* Spirometry with reversibility in FEV1 of ≥ 12% and ≥ 200 mL.
* Asthma Control Test™ (ACT) score ≤ 19.

Exclusion Criteria:

* Former smoker with \> 10 pack year history or current smoker.
* Patient with a urine level of cotinine ≥ 500 ng/mL.
* Co-sensitisation to any allergen possibly leading to clinically relevant symptoms likely to significantly change the asthma symptoms of the subject during the study.
* Patient who received allergen immunotherapy for HDM within the past 10 years.
* Ongoing immunotherapy for an aeroallergen other than house dust mite.
* Patient with any oral condition that could confound the safety assessments or planning to have a dental extraction during the study.
* Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
* Pregnant women or breast-feeding/lactating.
* Women with childbearing potential who are not using a medically accepted birth control method.
* Patient with a past or current disease, which as judged by the Investigator, may affect the patient's participation in, or the outcome of this study.