cyrilzakka/clinical-trials huggingface dataset:
Observational Study of Subcutaneous Immunoglobulin (Cutaquig) in Patients With Primary and Secondary Immunodeficiency.

This study will assess the relative safety, tolerability, and participant satisfaction in participants using the rapid manual push method with Cutaquig®. The hypothesis being that treatment with Cutaquig® by rapid manual push method will improve the safety, tolerability and patient satisfaction of participants with PID or SID.

Cutaquig® by rapid push is already approved in Canada and has proven to be efficacious in preventing significant infection. However, relative safety, tolerability, and patient satisfaction have not been studied in these patients. The information gained from this study will improve the safety and tolerability knowledge database and will support the optimal use of Cutaquig® - thus benefitting both physicians and patients.

Primary and secondary immunodeficiency diseases (PID and SID, respectively) affect the development and/or function of the immune system, resulting in increased frequency of infection. Treatment of these disorders using Cutaquig® (a subcutaneous immunoglobulin infusion (SCIG)) was licensed in Canada in 2018 and has proven to be effective in preventing significant infection. Other brands of SCIG can be given by the participant using a syringe (called rapid manual push method), which shows the same efficacy as administration by a programmable pump. The rapid manual push method has the potential to improve quality of life, reduce infusion time, and reduce the cost of administration. This study will evaluate the safety, tolerability, and patient satisfaction of Cutaquig® by the rapid manual push method in participants with PID or SID. It will also compare the efficacy of Cutaquig with prior SCIG treatment, if applicable, in participants with PID or SID.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years)
* Who have PID or SID requiring IgG replacement therapy
* For whom the investigator decides to maintain immunoglobulin replacement therapy with subcutaneous injections of Cutaquig® 165 mg/mL at home
* Having signed an informed consent form

Exclusion Criteria:

-Patients currently participating in another interventional study at the time of inclusion
Exploring Engagement Dynamics Among Individuals Impacted by Bladder Cancer

The study seeks to delve into the firsthand experiences of patients diagnosed with bladder cancer who partake in a separate clinical trial featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals.

By joining this clinical trial, individuals have the unique opportunity to contribute to the betterment of future bladder cancer patients and play an active role in advancing medical research.


Eligibility Criteria:
Inclusion Criteria:

* Patient has self-identified as planning to enroll in a clinical trial
* Patient has been diagnosed with bladder cancer
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Patient does not understand, sign, and return consent form
* Inability to perform regular electronic reporting
* Patient is pregnant
Co-administration of IVM and ALB in School-based Deworming in Uganda

The goal of this small-scale implementation research pilot study is to assess the feasibility and acceptability of the co-administration of ivermectin (IVM) and albendazole (ALB) compared to albendazole alone during school-based mass drug administration in Uganda. The study will target up to 10,000 school-aged children from 20 schools in Kabale and Kisoro districts in South-Western Uganda.

The main questions it aims to answer are:

* How feasible is the introduction of co-administered IVM plus ALB in the routine school-based deworming campaign in terms of training, material and processes?
* How well do beneficiary communities (pupils, parents) and implementers (teachers, health workers) accept the new treatment scheme and what are potential barriers and enablers for uptake?
* What are common implementation-related costs that can inform the methodology to estimate monetary and non-monetary costs as well as performance of the two treatment arms for the future cost-effectiveness analysis?

The study employs a cross-sectional mixed-method design (we will collect qualitative and quantitative data) to evaluate the feasibility and acceptability of co-administering IVM and ALB versus ALB alone in routine school-based mass drug administration. Assessments will take place during and after the drug distribution to document the implementation process and evaluate experiences made by the different stakeholders (e.g. children, parents, teachers, health workers):

* The implementation activities start with a training of all implementers at district level who will also undergo a pre- and post-training knowledge assessment.
* Schoolchildren aged 5-14 years will receive a single dose of ALB alone or co-administered ALb (400mg) and IVM (200µg/kg; as determined by height category on a dose pole) by health workers at school. 1-2 weeks post-distribution a subsample of 19 children per school will be invited to answer to questionnaires administered by social science researchers.
* Implementers will administer the treatments and document all distribution-related aspects during the campaign under supervision of the routine staff. Researchers will conduct additional monitoring and evaluation in order to assure data quality and provide support in performance assessment and cost evaluation.
* Beneficiaries (parents) and implementers will be asked to take part in focus group discussions and questionnaire interviews one week after the drug distribution.


Eligibility Criteria:
* School-aged children (5-14 years) of the selected schools
* Written informed consent from the participant's parents/caretakers and assent (for children aged 8 years and older) from the participant him/herself or written informed consent from the school teacher (for children attending schools receiving routine albendazole deworming)
* No signs of major acute or chronic illness
* No known allergy to study medication (i.e. benzimidazoles or ivermectin)
Open Cholecystectomy Among Patients Undergoing Laparoscopic Cholecystectomy.

In the current era, laparoscopic cholecystectomy is the treatment of choice for symptomatic gallstone disease. The aim of this study is to find out the prevalence of open cholecystectomy among patients undergoing laparoscopic cholecystectomy in a tertiary care center.

Laparoscopic Cholecystectomy (LC) is the gold standard surgery for symptomatic cholelithiasis with low mortality and morbidity.1,2 However, 1% to 15% of conversion rate to Open Cholecystectomy (OC) during laparoscopic cholecystectomy has been reported.3 Converted cases were associated with increased perioperative time, complication rates, perioperative costs, the length of hospital stay, and a higher 30-day readmission rate.3,4 Conversion was also associated with complications including bile leak, bile duct injury, or bleeding, requiring reoperation or transfusion, and death. A recent detailed critical review found that preoperative variables like male gender, older age, high body mass index, previous abdominal surgery, the severity of cholecystitis, and gallbladder wall thickness were associated with the higher rate of conversion to OC.4 However, data regarding its prevalence lacking in our setting.

The aim of this study is to find out the prevalence of open cholecystectomy among patients undergoing laparoscopic cholecystectomy in a tertiary care centre.

Eligibility Criteria:
Inclusion Criteria:

* All the cases of Symptomatic Cholelithiasis elected for Laparoscopic Cholecystectomy

Exclusion Criteria:

* Age \<10 years,
* Gall Bladder Malignancy,
* Adults with preoperative choledocholithiasis, and
* Perforated gall bladder
The Effect of Deep Neuromuscular Blockade on Requirement of Intravenous Anesthetic Agent

Recently, deep neuromuscular blockade during general anesthesia has been studied by many authors regarding various effects upon patients' outcomes and surgical conditions. We believe deep neuromuscular blockade can be especially beneficial in laparoscopic surgery, because it can expand surgical space and prevent patients' minute movements that can disturb precise operations. In clinical situations, anesthetists tend to compensate the insufficiency of neuromuscular blockade by increasing the dose of other anesthetic agents, which can prolong patients' recovery time and impair the surgical condition. In this study, we plan to divide the patients into 2 groups according to the depth of neuromuscular blockade, and compare the dose of anesthetic agent used to maintain surgical condition.

Patients undergoing elective laparoscopic colorectal surgery are going to be recruited and divided into 2 groups: Group D will receive deep neuromuscular blockade, and Group M will receive moderate neuromuscular blockade using continuous infusion of rocuronium. Acceleromyography(TOF-watch SX) will be used to monitor the depth of blockade. In both groups, the anesthesia will be maintained with TIVA(total intra-venous anesthesia) including continuous target-controlled infusion of propofol and remifentanil. During the surgery, the number of patient movement and restoration of self respiration will be recorded. At the end of anesthesia, the dose of propofol and remifentanil used will be assessed and compared between the groups. Also, the satisfaction score of surgeons regarding the surgical condition, the anesthesia time, the operation time will be documented. After the patients are discharged, their charts are going to be reviewed and whether any pulmonary or surgical complications occurred will be documented.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective laparoscopic colorectal resection due to benign or malignant neoplasm of colon or rectum
* ASA class I or II

Exclusion Criteria:

* Patients receiving medications known to have drug-drug interaction with neuromuscular blocking agents
* Patients who have significantly impaired cardiac, pulmonary, hepatic, renal function
* Patients who are pregnant
* Patients who are known to have hypersensitivity to the anesthetic/analgesic/neuromuscular blocking agents which are going to be used in the study
* BMI \< 18.5 or \> 35.0 kg/m2
* Patients with previous history of open abdominal surgery
* Patients with previous history of malignant hyperthermia
Biomarkers for Diagnosis and Prognosis of Endometrial Carcinoma

Endometrial cancer (EC) is the most frequent gynecological malignancy but there is currently lack of both non-invasive diagnostic tools and novel markers to stratify patients based on their risk of future recurrence. Patient care could be improved by advances in these two aspects.

In the present study, the investigators aim to identify diagnostic serum metabolite and protein biomarker signatures for early detection of cancer in asymptomatic high-risk population and prognostic biomarkers for selection of patients with poor prognosis.

Rationale: Endometrial cancer (EC) is the most frequent gynaecological malignancy in the developed world. Optimal treatment of EC depends on early diagnostics and pre-operative stratification to appropriately select the extent of surgery and to plan further therapeutic approach. Currently, invasive endometrial histology is the gold standard for diagnosis, as there are no valid non-invasive methods available, and patient stratification is based on histopathology and surgical findings. There is a great need for efficient and reliable screening test for asymptomatic women with high risk of EC including Lynch syndrome patients and tamoxifen treated patients. In addition, a prognostic test is needed to stratify pre-operatively EC patients with high risk of progression in need of radical surgery together with adjuvant chemo/ratio therapy from EC patients with good prognosis. In this project the investigators are addressing this lack of non-invasive diagnostic and prognostic biomarkers of EC.

Objective: the investigators aim to identify diagnostic serum metabolite and protein biomarker signatures for early detection of cancer in asymptomatic high-risk population and (secondary objective) prognostic biomarkers for selection of patients with poor prognosis.

Eligibility Criteria:
Inclusion Criteria Cases:

* endometrioid, serous, clear cell or mucinous endometrial cancer
* dedifferentiated endometrial cancer
* high grade or low grade endometrial cancer

Inclusion Criteria Controls:

* benign uterine diseases, e.g. myoma uteri, prolapsed uterus
* prophylactic hysterectomy for Lynch syndrome

Exclusion Criteria Cases:

* atypical hyperplasia
* other types of cancer
* sarcoma uteri
* previous diagnosis of endometrial cancer

Exclusion Criteria Controls:

* any cancer
* benign ovarian diseases
* previous EC
* pregnancy at the time of enrollment
Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities

A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia (HoFH).

Study Masking:

Part A: Open Label Part B: Double Blind

Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 12 to ≤ 80 years of age
* Diagnosis of homozygous familial hypercholesterolemia
* Stable lipid-lowering therapies for at least 4 weeks
* LDL cholesterol ≥ 130 mg/dl (3.4 mmol/L)
* Triglyceride ≤ 400 mg/dL (4.5 mmol/L)
* Bodyweight of ≥ 40 kg at screening.

Exclusion Criteria:

* LDL or plasma apheresis within 8 weeks prior to randomization
* New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction \< 30%
* Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months of randomization
* Planned cardiac surgery or revascularization
* Uncontrolled cardiac arrhythmia
* Uncontrolled hypertension
Variability in the Measurement of WBCT Between Blood Drawn From Indwelling Catheters and Direct Venipuncture

1. Determine if there is any difference between the whole blood clotting time results obtained from blood drawn from indwelling catheters and direct venipuncture
2. Determine the intra-subject variability in both procedures

No investigational products were administered to any subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated, written informed consent (Institutional Review Board \[IRB\]-approved informed consent form \[ICF\]).
2. Healthy (as determined by medical history) male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture.

Exclusion Criteria:

1. Healthy subjects who do not conform to the above inclusion criteria.
2. Healthy subjects who cannot communicate reliably with the Investigator.
3. History of major bleeding or major trauma within the past 6 months
4. Healthy volunteer with a propensity to bleed (i.e. due to recent trauma, recent surgery, peptic ulcer, active or recent gastrointestinal bleeding or bleeding from hemorrhoids).
5. Significant infection or known inflammatory process within 2 weeks of screening.
6. Treatment with any investigational products or therapies within 30 days (or 5 half lives, whichever is greater) prior to screening.
7. Received non-steroidal anti-inflammatory drug (NSAID) or medications (including aspirin) with a direct effect on hemostasis within 7 days of testing
8. Unwillingness or inability to comply with procedures required in this protocol.
9. Subjects who are concurrently enrolled in any other clinical study.
Effect of Lower Limb Resistance Versus Endurance Training in Smokers

Patients was selected based on inclusion and exclusion criteria. Experimental group was treated with Resistance training while control group received endurance training. Data was collected by spirometry and International Physical activity questionnaire readings was recorded in every session for baseline, 3rd week and 6thweeks.

Experimental group will receive lower limb strength training and control group will receive endurance training. Both groups will receive treatment for three days a week and each session will be given according to FITT formula. Measurement will be recorder pre-treatment and post treatment of both groups at baseline, third , and 6 th week.

Eligibility Criteria:
Inclusion Criteria:

* Young cigarette smokers (10 cigarette/day for at least 10 years)
* Male
* Age 25-45 years
* Sedentary lifestyle
* Body mass: less than 80kg
* BMI:22-30

Exclusion Criteria:

* Heart or pulmonary disease
* MSK disorder
* incapable of realizing the protocol of exercises,
* Recent surgery
* Recent Trauma.
* Any infective respiratory illness.
Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema

Cardiogenic pulmonary edema (CPE) is a common medical emergency and noninvasive ventilation (NIV) in addition to conventional medical treatment might be beneficial for patients with CPE.

To evaluate the effect of adding continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) to standard medical therapy (ST) on intensive care unit (ICU) stay, hospital stay, mortality, need for endotracheal intubation, partial arterial O2 tension (PaO2), intrapulmonary shunt, alveolar-arterial (A-a) oxygen gradient, and cardiac output in patients admitted to the respiratory intensive care unit (ICU) or cardiac care unit (CCU) with acute CPE with gas exchange abnormalities and to evaluate the impact of heart failure type on the outcome of different therapeutic schedules.

Eligibility Criteria:
Inclusion Criteria:

1. CPE confirmed radiologically and/or clinically
2. Severe acute respiratory failure (partial arterial oxygen (PaO2)/Fraction of inspired oxygen (FIO2) less than 250)
3. Dyspnea of sudden onset with respiratory
4. Systolic blood pressure \< 180 mmHg

Exclusion Criteria:

1. Immediate need for endotracheal intubation:

   * Severe sensorial impairment
   * Shock
   * Ventricular arrhythmias,
   * Life-threatening hypoxia (SpO2 \[oxygen saturation as indicated by pulse oximetry\] less than 80% with oxygen)
   * Acute myocardial infarction necessitating thrombolysis
   * Cardiac or respiratory arrest
2. Severe chronic renal failure
3. Pneumothorax.
4. Contraindication of non invasive ventilation (NIV)
Clinical Study of LY011 in the Treatment of Advanced Pancreatic Cancer

CLDN 18.2 chimeric antigen receptor T cells Clinical research plan for the treatment of recurrent or refractory pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* They were 18 to 70 years old, male or female;
* Definitive diagnosis is recurrent or refractory pancreatic cancer;
* Claudin 18.2 IHC staining was positive in tumor tissues;
* Life expectancy \> 12 weeks;
* According to RECIST 1.1, there was at least one measurable tumor target;
* ECoG scores at screening, 24 hours before puncture and baseline (before treatment) were 0-1;
* Adequate organ function;
* Women of childbearing age with negative pregnancy test or male subjects must take effective and reliable contraceptive methods until 30 days after the end of treatment;
* Have enough understanding ability to voluntarily sign informed consent to participate in clinical research.

Exclusion Criteria:

* Pregnant or lactating women;
* HIV, syphilis spirochete or HCV serological positive;
* Any uncontrollable active infection, including but not limited to active tuberculosis, HBV infection (HBsAg positive, HBcAb positive, HBV DNA positive);
* The subjects were judged as clinically significant thyroid dysfunction by the investigators (serum thyroid hormone determination TT4, TT3, FT3, FT4, serum thyroid stimulating hormone TSH) and were not suitable to participate in this study;
* The side effects of the patients were not recovered to CTCAE ≤ 1;
* Subjects who are currently using steroids all over the body within 7 days before the pregnancy is taken out; Inhaled steroids are not excluded in the near future or in the near future;
* Previous allergies to immunotherapy and related drugs, severe allergies or allergies;
* T cells (including car-t, tcr-t) that have been modified by chimeric antigen receptor have been reported.
* The subjects had untreated or symptomatic brain metastasis;
* The subjects had heart disease which needed treatment or after treatment, hypertension was out of control (blood pressure \> 160 mmHg / 100 mmHg);
* Subjects with or waiting for organ transplantation history;
* No other serious disease may limit subjects' participation in this trial
* The researchers assessed that subjects were unable or unwilling to comply with the requirements of the study program.
* It has abnormal signs of central nervous system diseases or abnormal results of nervous system detection, which has clinical significance;
* Subjects currently or had other malignant tumors that could not be cured within 3 years, except for in situ cervical or skin basal cell carcinoma.
Assessment of Neuropsychiatric Function in Patients With Interstitial Lung Disease

Research on the impact of lung diseases on neuropsychological functioning has revealed impaired cognitive processing in patients with a variety of pulmonary disorders. While the mechanisms responsible for the association of pulmonary diseases and neurocognitive functioning remain unclear, some researchers have attributed it to reduced oxygenation of the brain. Early detection and accurate management of comorbidity have benefits in reducing ILD morbidity and mortality.

Research on the impact of lung diseases on neuropsychological functioning has revealed impaired cognitive processing in patients with a variety of pulmonary disorders. While the mechanisms responsible for the association of pulmonary diseases and neurocognitive functioning remain unclear, some researchers have attributed it to reduced oxygenation of the brain.

Interstitial Lung Disease (ILD) is an "umbrella" term as it comprises a variety of pulmonary diseases which affect the interstitium (the tissue and space around the air sacs of the lungs). It may be caused by a variety of factors (namely, inhaled substances, medications, infection, connective tissue disease, malignancy or idiopathic reasons) and has a clear negative impact on patients' quality of life, leading to symptoms such as fatigue, dyspnea and coughing. Physical sequelae include reduced lung volumes due to tissue thickening, sometimes caused by inflammation. A further consequence is reduced breathing efficiency, resulting in reduced blood oxygen levels and compromised exercise capacity.

Additionally, the fibrosis of the parenchyma impedes the level of gas exchange. A number of studies have reported mood effects in ILD, suggesting, however, that the diagnosis of depression may be obscured, due to the fatigue and apathy that is often a consequence of ILD.

Early detection and accurate management of Neuropsychiatric comorbidities have benefits in reducing ILD morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Interstitial lung disease patients diagnosed using high resolution computed tomography to confirm the diagnosis

Exclusion Criteria:

* Patients who refuse to participate in the study.
* Age less than 18,
* A history of neurological and/or developmental disorders and related drug treatment,
* A head injury with loss of consciousness,
* Active alcohol or drug abuse or a history of abuse prior to testing,
* A history of any psychiatric disorder or treatment, neurological disorders, psychological disorders, dementia, Alzheimer's disease, end-organ failure conditions