cyrilzakka/clinical-trials huggingface dataset:
Development and Validity of the DyNaChron Questionnaire for Chronic Nasal Dysfunction

Nasal symptoms are the main elements that lead to a therapeutic decision and allow for evaluating treatment effects or natural evolution. Despite availability of several questionnaires with good measurement qualities, no systematic assessment takes into account the specific physical and psychosocial consequences of each of the six main nasal symptoms, independently of the disease. The study proposed to measure these symptoms with the use of a selfreport questionnaire and to test the validity of the questionnaire in a large representative sample of patients attending outpatient rhinologic clinics.

The study was conducted in two parts: (1) expert-based development and testing of the face validity of a questionnaire in French; and (2) validity testing, including construct validity by factor analysis, reproducibility by intraclass correlation coefficient (ICC) and Bland and Altman plots, and sensitivity to change by standardized response means, on a large sample of patients in a prospective multicenter study. DyNaChron, a questionnaire with 78 items divided into six domains and exploring both the physical and psychosocial repercussions of CND, was developed. In total, 759 patients completed the questionnaire at a first visit to a clinic, and 539 again 19.5 days later, on average.

Eligibility Criteria:
Inclusion Criteria:Patients had to

* be older than 18 years
* have nasal or sinus dysfunction for more than 3 months
* be able to understand and read theFrench language.

Exclusion Criteria:

* nasal or sinus tumor or Rendu-Osler disease,
* patients were under immediate post-operative care
Dexlansoprazole MR in Nonerosive Reflux Disease

This study aim is to compare the efficacy of Dexlansoprazole MR intake before and after breakfast in patients with nonerosive reflux disease.


Eligibility Criteria:
Inclusion Criteria:

* NERD confirmed by gastroscopy

Exclusion Criteria:

* PPI medication within 2 weeks before enrollment
Artificial Intelligence-Based Analysis of Uroflowmetry Patterns in Children: a Machine Learning Perspective

Uroflowmetry is the one of the most commonly used non-invasive test for evaluating children with lower urinary tract symptoms (LUTS). However, studies have highlighted a weak agreement among experts in interpreting uroflowmetry patterns. This study aims to assess the impact of machine learning models, which have become increasingly prevalent in medicine, on the interpretation of uroflowmetry patterns.

The study included uroflowmetry tests of children aged 4-17 years who were referred to our clinic with lower urinary tract symptoms. Uroflowmetry patterns were independently interpreted by three pediatric urology experts. Discrepancies in interpretations were jointly re-evaluated by the three observers, and a consensus was reached. Voiding volume, voiding duration, and urine flow rates at 0.5-second intervals were converted into numerical data for analysis. Eighty percent of the dataset was used as training data for machine learning, while there maining 20% was reserved for testing. A total of five different machine learning models were employed for classification: Decision Tree, Random Forest, CatBoost, XGBoost, and LightGBM. The models that most accurately identified each uroflowmetry pattern were determined.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 4 and 17 years with LUTS
* Urinate more than 50% of the expected bladder capacity on UF

Exclusion Criteria:

* Patients who were unable to cooperate with the voiding command
* Had neurological disorders
* Urinate less than 50% of the expected bladder capacity on UF
* Under 4 years of age, and were over 18 years of age
Assessment of Tele-expertise for Frozen Section Diagnosis

The purpose of the study is to assess whether performing a frozen section diagnosis off site with virtual slides would be as quick and accurate as usual technique.


Eligibility Criteria:
Inclusion Criteria:

* All patients

Exclusion Criteria:

* None
Treatment Goals in Psoriatic Arthritis

The PaGoPsA study objective is to ascertain if guideline-based psoriatic arthritis clinical care achieves individual patient goals as articulated by patients, and to identify predictors of achieving individual patient goals from psoriatic arthritis treatment.

Psoriatic arthritis (PsA) is a heterogeneous autoimmune disease that occurs in one in three people with the skin disease psoriasis. PsA can cause arthritis (joint inflammation), enthesitis (tendon and ligament inflammation), sausage digits (swollen entire finger or toe), spondyloarthritis (spinal inflammation). Skin involvement by psoriasis is also highly variable in terms of psoriasis type and location. Through combined skin and musculoskeletal involvement, psoriatic disease has a significant life impact with decrease quality of life including uncomfortable symptoms, ability to participate in life and functioning. Medications used to treat PsA have sometimes an uneven effect on the various PsA manifestations where some are more effective for skin while others more effective for the joints. In this context, clinical care and treatment of PsA is a complex process which balances disease activity with medication risks and benefits as well as patient priorities. Professional PsA treatments guidelines state that PsA treatment goals are disease remission or low disease activity. Several studies to date have shown that physicians tend to overestimate remission and low disease activity in PsA patients when compared to disease activity indices. Also patients and physicians frequently do not align on perceptions of remission or low disease activity. In the proposed study the investigators aim to identify predictors of successful treatment from a patient perspective on a range of disease measures including psoriasis, arthritis, enthesitis, dactylitis, patient reported outcomes, and laboratory assessments which are routinely collected in the clinical care of PsA. Secondary endpoints are to quantify longitudinally how stable a state of treatment success is from a patient perspective, and to define score ranges for disease measurements, including health-related quality of life measures, that correspond to treatment success from a patient perspective. The impact of this research is that the investigators will be able to define parameters predictive of achieving treatment success from a patient perspective, which will then inform goals of care for psoriatic arthritis.

Eligibility Criteria:
Inclusion Criteria:

* English speaking/reading adults
* Patients of the Johns Hopkins Arthritis Center and/or the Johns Hopkins Psoriatic Arthritis Clinical Program
* Followed every 3-4 months for regular psoriatic arthritis clinical care
* Meet Classification Criteria for Psoriatic Arthritis (CASPAR)
* Able to interact with touch screen computer.

Exclusion Criteria:

None
Effects of Chronic Ozone Exposure on Lung Function

To determine the effects of chronic ozone exposure on lung function in young men and women.

BACKGROUND:

A large part of the U.S. population is exposed to ambient ozone (O3) concentrations that are associated with acute respiratory health effects; however, little is known about the effects on human respiratory health of long-term exposure to such ambient concentrations. Chronic exposure of non-human primates to high concentrations of O3 are associated with pathologic changes in the centriacinar region of the lung that are similar to changes observed in young cigarette smokers. This is the first detailed epidemiologic study of the effects of chronic exposure to an air pollutant based on individual estimates of lifetime exposure and controlled exposure data. The study tests a specific toxicologic model in humans that has relevance for chronic respiratory disease and explores mechanisms of effects.

DESIGN NARRATIVE:

The study tested the hypothesis that, in humans, there was an exposure-response relationship between the amount of chronic exposure to ambient O3 and measures of lung function that reflected changes in the centriacinar region of the human lung (FEF25-75); and this relationship was not seen with measures of more proximal airway function (FEV1). First-year UC Berkeley students, ages 18-21 yrs, who were lifelong residents of the Los Angles Basin, (high O3) and the San Francisco Bay Area, (low O3) were studied. Lifetime exposure to ambient O3 was estimated with methods developed by the investigators that combined questionnaire and ambient O3 data. Lung function was assessed with maximum expiratory flow-volume curves. Students were studied after 4-6 months of low ambient O3 exposure and immediately after 2-3 months of exposure to summertime O3. Students from each area who were at the upper and lower tails of the FEF25-75 distribution underwent two controlled O3 exposures (seasonal as above) followed by bronchoalveolar lavage/biopsy to evaluate relationships between measures of inflammation, injury/repair and oxidant induced damage/repair and FEF25-75. Regression was used to evaluate relationships between lifetime O3 exposure and lung function, adjusted for past and family respiratory history, allergy history, home characteristics, exposure to environmental tobacco smoke and particle air pollution and NO2.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Validation Study on the Removal of EpCAM-positive Tumour Cells From Blood Collected During Tumour Surgery Using Catumaxomab/Catuvab Device

The REMOVE study was an open-label, multicenter validation study on the removal of EpCAM-positive tumor cells from blood collected during tumor surgery using the CATUVAB Kit. The aim of the REMOVE clinical study was to demonstrate the safety and efficacy of the application of the new medical device CATUVAB to allow retransfusion of autologous erythrocyte product produced by an intraoperative blood salvage (IBS) device during oncological high blood loss surgery. The primary objective of the study was to demonstrate that CATUVAB device utilized during autologous blood salvage procedures (including LDFs) depletes intraoperative blood of EpCAM-positive tumor cells.


Eligibility Criteria:
Inclusion Criteria:

* Intraoperative blood salvage (IBS)-eligible according to the Investigator
* Patients with a prostate tumor, gallbladder carcinoma, bladder carcinoma, endometrial carcinoma, gastric carcinoma, ovarian carcinoma, pancreatic carcinoma, colon / rectal carcinoma, non-small cell lung cancer, or peritoneal carcinomatosis, i.e., cancer types with a high likelihood of being EpCAM-positive (\>92%) OR kidney carcinoma or liver carcinoma.
* For patients with cancer types with a high likelihood of being EpCAM-positive (\>92%): if a tumor tissue sample is available and has been EpCAM tested or EpCAM-testing can be done within 5 days of signing the informed consent form (ICF): results of EpCAM typing should be positive.
* For patients with kidney carcinoma or liver carcinoma: a tumor tissue sample must be available and have tested EpCAM-positive prior to surgery.
* Scheduled for surgery to remove tumor.
* The Investigator expects that at least 400 mL full blood can be collected during the tumor surgery.
* An American Society of Anesthesiologists (ASA) Classification of ≤3.

Exclusion Criteria:

* Adjuvant therapy and intra-operative chemotherapy (hyperthermic intraperitoneal hemotherapy, HIPEC) started before blood collection for IBS is completed.
* Lymphocytopenia (count \<1.0 x 109 /L lymphocytes).
* Cancer different from indicated types, especially typically EpCAM-negative tumor types.
* Sepsis occurring during surgery.
* Cirrhosis of the liver with a Child-Pugh score of C.
* A thrombocyte count of \<30.000/µL.
* Allergies and/or contraindications against Catumaxomab or any of the components or ingredients used in the IBS procedure (e.g., leukocyte depletion filter \[LDF\], diluent, buffer solution or anticoagulants).
* Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, confirmed by a positive polymerase chain reaction (PCR) test prior surgery.
Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancrease Cancer

A prospective evaluation of neoadjuvant FOLFIRINOX regimen in patients with non-metastatic pancreas cancer (Baylor University Medical Center and Texas Oncology Experience)

Patients with pancreas cancer will be enrolled and treated with a planned course of 6 cycles (3 months) of chemotherapy with FOLFIRINOX prior to undergoing surgical resection.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Male or non-pregnant and non-lactating female
* Histologically or cytologically confirmed adenocarcinoma of pancreas
* Patients must have satisfactory blood counts and blood chemistry levels at baseline (refer to Appendix 2, Study Laboratory References Range).
* Patient has Eastern Cooperative Oncology Group(ECOG) Performance Status 0 to 1 (refer to Appendix 7):
* 0 - Asymptomatic (Fully active, able to carry on all predisease activities without restriction)
* 1 - Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work)
* Signed study consent form

Exclusion Criteria:

* \<18 years of age
* Pregnant or lactating female
* Patient has islet cell neoplasms
* Patient has known brain metastases
* Patient has metastatic disease
* Active secondary malignancies
* Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
* Known infection with hepatitis B, hepatitis C, or cirrhosis
* Major surgery or vascular device placement (excluding ports for IV medication/chemotherapy) within 2 weeks prior to Day 1 of treatment in study
* Prior chemotherapy or radiation for pancreatic cancer
* History of allergy or hypersensitivity to the study drugs
* Patient is enrolled in any outside (outside Baylor University Medical Center or Texas Oncology) clinical protocol or investigational trial
* Significant cardiac disease as defined as New York Heart Association (NYHA) classification III or IV, uncontrolled congestive heart failure (CHF), or prior myocardial infarction (MI) last 6-months
* Any prior gastrointestinal (GI) disease or history of prior pelvic or abdominal radiation which in the opinion of the investigator may place the patient at increased risk
* Peripheral sensory neuropathy ≥ to grade 2 at baseline
* Significant co-morbidities deemed by investigator as unsuitable for participation/enrollment
* Study consent form not signed
Metformin and Folate Supplementation in Polycystic Ovary Syndrome (PCOS) Patients

Context: Metformin administration in women with polycystic ovary syndrome (PCOS) improves hormonal and metabolic patterns with beneficial effects in terms of reproductive outcomes and intermediate cardiovascular disease risk factors. Furthermore, reduced folate and vitamin B12, and increased homocysteine (Hcy) levels have been found in type-2 diabetes mellitus patients treated with metformin.

Objective: To evaluate if metformin administration exerts any effects on Hcy levels, and if folate supplementation may improve endothelial structure and function in PCOS patients.

Fifty patients affected by PCOS without additional metabolic or cardiovascular diseases grouped in two age- and body mass index-matched treatment arms.

Interventions: A six-month course of metformin (1700 mg daily) plus folic acid (400 microgram daily) (experimental group, n=25) or placebo (control group, n=25) supplementation.

In each patient were evaluated: Complete hormonal and metabolic patterns, serum Hcy, folate, vitamin B12, and endothelin-1 (ET-1) concentrations, brachial artery diameter at baseline (BAD-B) and after reactive hyperemia (BAD-RH), flow-mediated dilation (FMD), and intima-media thickness (IMT) on both common carotid arteries.

Eligibility Criteria:
Inclusion Criteria:

* PCOS

Exclusion Criteria:

* age \<18 or \>35 years
* BMI \>35 kg/m2
* neoplastic, metabolic, hepatic, renal, and cardiovascular disorders
* Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.
Comparison of Perioperative Analgesia Between Intravenous Paracetamol and Fentanyl for Rigid Hysteroscopy

Objective of study:

To compare the efficacy of intravenous paracetamol and fentanyl for intra-operative and post-operative pain relief in patients undergoing diagnostic and therapeutic hysteroscopy.

Hypothesis of study:

There is no difference in pain control between intravenous fentanyl and paracetamol in patients undergoing hysteroscopy.

Intraoperative pain assessment will be based on:

Hemodynamic vital (SBP, DBP. MAP and HR) increase 20% from the baseline will be observed and assumed pain.

Postoperative pain assessment will be based on:

Mean Pain score :Visual analogue pain scale (VAS) of 0-10 cms will be used to assess the pain at the end of the procedure.

Diagnostic hysteroscopy:

Patients presenting with abnormal premenopausal or postmenopausal uterine bleeding, pain, infertility, intrauterine adhesions, endometrial biopsy, foreign body.

Therapeutic hysteroscopy:

To remove IUD, uterine polyps, fibroid, foreign body and submucosal fibroids, sterilization.

Eligibility Criteria:
Inclusion Criteria:

* Elective surgery
* American Society of Anaesthesiologists (ASA) grade I \& II

Exclusion Criteria:

* Patients with anticipated difficult airway
* Gastro-oesophageal reflux disorder
* Body mass index (BMI) \>30kg/m2
* Known Hepatic disorder
* Known ischemic heart disease
* History of hypersensitivity reactions to paracetamol and fentanyl or already taking paracetamol and fentanyl
* Patient experiencing the iatrogenic intra-operative uterine perforation
Sub-dissociative Intranasal Ketamine for Pediatric Sickle Cell Pain Crises

The purpose of this study is to determine if the use of ketamine, sniffed in the nose, is a safe and effective way to help reduce pain in pediatric sickle cell patients with pain crises in resource-limited settings.

This is a randomized, placebo-controlled, drug trial using sub-dissociative intranasal ketamine as an adjunct to standard pharmacotherapy for the management of pediatric sickle cell disease vasoocclusive pain crises in resource-poor settings. Pediatric patients will be enrolled at a teaching and referral hospital in West Africa. Patients will be randomly assigned to the treatment arm - standard therapy plus sub-dissociative intranasal ketamine (1 mg/kg) given at time zero) or the control arm - standard therapy plus intranasal normal saline (volume-matched to treatment arm), and patients will evaluated at standard intervals to assess for pain scores and vital signs (0 minutes, 30 minutes, 60 minutes, and 120 minutes). Pain will be assessed using the Faces Pain Scale - Revised (FPS-R). Patients will also be observed for any potential side effects or adverse events. All patients will be contacted 2-3 weeks post intranasal medication administration for over-the-phone follow-up using a portion of the PedsQL-SCD questionnaire, to assess for basic quality of life related to pain management and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Sickle cell disease (SCD)
* Vasoocclusive pain crisis
* Requiring analgesia

Exclusion Criteria:

* Anatomic variations of nose precluding intranasal medication administration
* Ketamine allergy
* Non-verbal
* Obtunded
* Pregnant
* Other acute SCD complications:

  * Acute chest syndrome
  * Sepsis
  * Stroke
  * Splenic sequestration
  * Pulmonary embolism
  * Acute osteomyelitis
A Prospective Study to Evaluate the Consistency of Next-Generation Sequencing(NGS)-Panels by Using Malignant Hydrothorax Form NSCLC

A prospective study to evaluate consistency of different NGS-panel. Cell free DNA is purified from each malignant hydrothorax from NSCLC .Different NGS-panels are applied to perform in vitro diagnosis to detect Single Nucleotide Variants(SNV) and to calculate TMB value in these DNA samples.Consistency of enrolled NGS-panels are then evaluated by statistical analysis.

1. Chest Hospital in accordance with the clinical requirements of the treatment required to extract ML hydrothorax sent to hospital pathology department for exfoliated Cell diagnosis and production of cell wax block, while the additional responsibility for the extraction of hydrothorax 500ml, and collect 10ml venous blood sample, Venous blood samples are stored in either the A cell-free DNA Blood collection Tube (STRECK tube) or the ethylenediaminetetraacetic acid(EDTA) anticoagulant tube.
2. Amoy Diagnostics Co., Ltd. (AmoyDx) is responsible for plasma separation after sampling 2 hours, plasma is frozen by the chest Hospital, AmoyDx completes the purification of peripheral blood cells genomic DNA , and which is divided into 6 parts ,5 of which are send to in vitro diagnostic products (IVD) enterprises to perform NGS-Panel detection.
3. 100ml hydrothorax is send to each IVD enterprise.
4. Each IVD enterprise carries on the hydrothorax cell free DNA and peripheral blood cell genomic DNA NGS-Panel detection according to their own protocol.
5. Each IVD enterprise will complete the test within 7-10 working days and fill out the results in accordance with the report template provided by this research project (provided by Guangzhou Burning Rock Medical Examination Institute Co., Ltd.) and submit to sponsor by email.
6. Sponsor would use whole exon panel (WES) to obtain an TMB value if needed.
7. Employ four-grid analysis to evaluate positive compliance rate, negative compliance rate, total compliance rate of all submitted data.
8. Employ kappa test to evaluate the consistency of each two detections.

Eligibility Criteria:
Inclusion Criteria:

* Advanced malignant lung cancer, with treatment of pleural effusion, hydrothorax volume not less than 800ml

Exclusion Criteria:

* The sample size is not sufficient to detect.
* There are not enough tumor cells in the tissue section to be evaluated through the pathology department of the chest Hospital.
The Effect of N2O on Chronic Neuropathic Pain Patients

Important pharmacological agents for treatment of chronic neuropathic pain such as ketamine block NMDA receptors. Nitrous oxide, an inhalant agent used extensively In anesthesia, also have antagonist property of NMDA receptors. The investigators hypothesize that prolonged treatment with N2O can alleviate chronic neuropathic pain of different causes (e.g. diabetic neuropathy, post herpetic neuralgia etc.).

Important pharmacological agents for treatment of chronic neuropathic pain such as ketamine block NMDA receptors. Nitrous oxide, an inhalant agent used extensively In anesthesia, also have antagonist property of NMDA receptors. The investigators hypothesize that prolonged treatment with N2O can alleviate chronic neuropathic pain of different causes (e.g. diabetic neuropathy, post herpetic neuralgia etc.). In order to examine our theory we Will recruit 40 patients aged 18-65 that suffer from chronic neuropathic pain. The patients will be divided to two groups of which half will receive treatment with N2O and half with placebo (pure O2) as a repeated weekly treatment for 4 weeks. At the beginning of the each session the patient will be asked to fill questionnaires regarding their pain quality and severity

Eligibility Criteria:
Inclusion Criteria:

* men and women at the age 18-65
* patient that suffer from chronic neuropathic pain
* VAS\>40
* DN4 score \>4
* takes pain medication on a regular basis
* Didn't get epidural injection for the pas month
* signed an informed consent form

Exclusion Criteria:

* patients that suffer from chronic lung disease.
* patients with cancer
* patients with heart disease
* pregnant and lactate woman
* patients that suffer from depression