cyrilzakka/clinical-trials huggingface dataset:
A Prospective Study of Constructing Immune Repertoire to Monitor the Therapeutic Effect in NSCLC Patients

This study is designed to evaluate the untreated NSCLC patients. After participants have accepted chemotherapy, radiotherapy, and immunotherapy, the investigators used the next generation sequence technology (NGS) to construct immune repertoire to detective variation of patients' immune state and to monitor patients' therapeutic effect. The investigators are aim to explore the novel clone sequence as potential therapy target.

Lung cancer was one of the most deadly tumors in the world. The standard of care for patients is platinum-based doublet chemotherapy concurrent with radiotherapy. As for patients with a mutant epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase(ALK), EGFR or ALK tyrosine kinase inhibitors (TKIs) are the standard first-line therapy. Now, the Food and Drug Administration approved Ipilimumab, Nivolumab, and Pembrolizumab as first-line or second-line therapy for NSCLC. However, there was no reports about therapeutic effect for NSCLC patients through detecting herself immune state, immune repertoire could explore patients' immune clonality and diversity using NGS technology.The investigators look forward to illuminate the mechanism of patients antitumor action.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically verified stage IV non-small cell lung cancer without treated.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Major organs function normally
* Women at pregnant ages should be under contraception
* Willing and able to provide informed consent

Exclusion Criteria:

* Pathology is mixed type•
* Poor vasculature
* Coagulopathy, or ongoing thrombolytics and/or anticoagulation
* Blood-borne infectious disease, e.g. hepatitis B
* History of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician
* Other conditions requiring exclusion deemed by physician
A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE)

The purpose of the study is to assess the Safety, Tolerability, PK/PD and preliminary Efficacy of ICP-022 in Subjects with Systemic Lupus Erythematosus (SLE)


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged 18 to 75
2. diagnosis of with SLE at least 6 months at screening visit
3. SLEDAE-2K≥5
4. Is receiving standard treatment for SLE and has been receiving treatment for at least 3 months.
5. At least one SLE activity manifestation (as assessed by SLEDAE-2K)

Exclusion Criteria:

1. Failure to comply with the requirements of the programme
2. A female or male partner who is pregnant or breastfeeding or who plans to become pregnant during the study period
3. Previously treated with a BTK inhibitor
4. Neuropsychiatric lupus (NPSLE)
5. Has other autoimmune diseases other than SLE

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
First Aid Needs of Female Agricultural Workers and the Impact of Basic First Aid Training on Their Knowledge Levels

This study aims to investigate occupational health risks faced by female agricultural workers and their need for first aid training. The objective is to evaluate the effectiveness of a basic first aid training program in enhancing knowledge and practical skills, thereby improving workplace safety and individual health outcomes.

This research focuses on identifying the first aid needs of female agricultural workers and assessing the impact of a structured basic first aid training program on their knowledge and practical skills. The study will be conducted in Kadıköy neighborhood, Silivri district, Istanbul Province, a region with active agricultural activities.

The training program integrates theoretical and practical components, designed in collaboration with 10 experts in the field. Theoretical sessions will be delivered through presentations and educational brochures. Practical training will include hands-on demonstrations and skill assessments, focusing on bleeding control and the Heimlich maneuver. Simulated scenarios will be employed using an arm model with moulage and a CPR manikin, with performance evaluated through standardized assessment forms.

The study is scheduled to take place from November 2024 to May 2025. Data collection will involve pre-training assessments to establish baseline knowledge and skills, immediate post-training evaluations to determine the program's effectiveness, and a six-month follow-up to assess knowledge retention and the real-world application of first aid skills. A total of 43 participants, calculated using G\*Power analysis for a repeated-measures design, will ensure adequate statistical power.

By addressing the first aid needs of female agricultural workers, this study aims to enhance workplace safety, empower workers to manage occupational risks effectively, and contribute to better health outcomes within agricultural settings.

Eligibility Criteria:
Inclusion Criteria:

* Being a female agricultural worker,
* Being 18 years of age or older,
* Willing to participate in the study,
* Having no hearing impairment.

Exclusion Criteria:

• Not having attended one of the training sessions conducted by the instructor.
Series of N-of-1 Crossover Trials of Antihypertensive Therapy in Adolescents With Essential Hypertension

Children are increasingly being diagnosed with essential hypertension and the absence of comparative effectiveness research in antihypertensive therapies has contributed to considerable differences in prescribing practices among physicians treating children with essential hypertension.

This study will consist of a series of systematically-administered n-of-1 trials among children to verify the need for ongoing antihypertensive treatment and if so, to identify the preferred single drug therapy.

This is a series of systematically-administered n-of-1 trials among children with essential hypertension to verify the need for ongoing antihypertensive treatment and if so, to identify the preferred single drug therapy from among the three major classes of drugs commonly used for essential hypertension (angiotensin converting enzyme inhibitors, calcium channel blockers, and diuretics). The investigators will determine whether there is one that is preferred for the great majority of patients. The "preferred" therapy will be defined as the drug which produces normal ambulatory blood pressure, with the greatest reduction in awake mean systolic blood pressure without unacceptable side effects.

For each patient, the order of the 3 drugs will be assigned randomly and each drug will be taken for 2 weeks. The effectiveness of each drug will be measured with 24-hour ambulatory blood pressure monitoring, and tolerability will be assessed using a side effect questionnaire. Participants will rotate through treatment periods, repeating drugs and adjusting doses until the preferred therapy is identified. In assessing whether one the medications is most effective for the great majority of subjects, the primary outcome will be the percentage of participants for whom each drug is selected as the preferred therapy. Primary hypothesis: no drug will be selected for the majority of the subjects, a finding that would support consideration of clinical use of n-of-1 trials. Secondary analyses will explore whether patient characteristics predict which medication will be selected as a preferred drug.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of essential hypertension
* Treating physician has determined that pharmacologic therapy is necessary

Exclusion Criteria:

* Compelling indication to select one particular medication
* Specific contraindication for any of the 3 therapies
Safety Surveillance of Targeted Drugs for Pulmonary Hypertension Using a Computerized Follow-up System: a Nationwide Cohort Study

Recruit at least 700 PH patients, follow up every 6 months based on a computerized follow-up system. Primary outcomes are adverse drug events and all-cause death.


Eligibility Criteria:
Inclusion Criteria:

* Age from 3 months to 85 years, no sex preference;
* Right heart catheter meet the following conditions simultaneously: mPAP≥25mmHg, and PVR \> 3 Wood units(in children PVRi \> 3 WU x m2), and PAWP≤15 mmHg at rest;
* Patients diagnosed with group 1,2,4,5 PH according to the WHO classification, detailed description is as follows: Pulmonary arterial hypertension, Lung disease / chronic hypoxia associated pulmonary hypertension, Pulmonary hypertension associated with pulmonary artery stenosis / obstruction and Pulmonary hypertension caused by other multiple factors
* Take at least one pulmonary hypertension targeted drug or calcium antagonist;
* Signed written informed consent.

Exclusion Criteria:

* Patients diagnosed with pulmonary hypertension related to left heart disease;
Investigations on the Influence of Bariatric Surgery on the Metabolism and Absorption of Atorvastatin

Altered bioavailability of drugs will potentially affect both drug efficacy as well as safety. In patients subjected to bariatric surgery due to morbid obesity the gastro intestinal tract is considerably reconstructed and a change in drug bioavailability is very likely. Getting further knowledge on important mechanisms responsible for altered bioavailability would help in predicting clinically relevant consequences on different drugs.

In the present study we aim to investigate the effect of bariatric surgery on atorvastatin bioavailability. Atorvastatin is subjected to both extensive metabolism and drug transport and will potentially be a good predictor for mechanisms relevant for other drugs as well.

In addition will the expression of different enzymes and transporters be measured in the gastrointestinal tract and in the liver to elucidate on mechanism behind the eventual effects.

The primary objective of the study is to compare the effect of gastric bypass and BPD+DS operations on atorvastatin bioavailability.

Secondary objectives are to determine the relative change in atorvastatin bioavailability following gastric bypass as well as BPD+DS operations. In addition will the individual CYP3A4, CYP3A5 and P-gp activity in the different organs from where biopsies can be obtained be descriptively compared with atorvastatin pharmacokinetic variables.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for bariatric surgery.
* 18 years of age or older.
* Ongoing treatment with statin.
* Able and willing to donate GI-tract and liver biopsies.
* Signed informed consent.

Exclusion Criteria:

* Concomitant treatment with drugs and/or other factors that may influence atorvastatin pharmacokinetics
EURopean Trial In Atrial Fibrillation(AF) or Flutter (AFL) Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS)

To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation/atrial flutter (AF/AFL).

To assess the efficacy of dronedarone versus placebo on AF/AFL-related symptoms.

To assess the efficacy of dronedarone versus placebo on ventricular rate control in case of AF/AFL recurrence.

This is a double-blind, parallel arm, placebo-controlled, multicentre, multinational, phase III study.

To be eligible, patients must be in normal sinus rhythm at randomisation and must have an ECG-documented history of recent AF/AFL reverted to normal sinus rhythm by electrical, pharmacological or spontaneous conversion

Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex aged 21 years or more, in sinus rhythm for at least 1 hour at the time of randomization and with at least one ECG-documented AF/AFL episode in the last 3 months.

Exclusion Criteria:

* MAIN CRITERIA (non-exhaustive list, see protocol for details):

Women of childbearing potential without adequate birth control, Pregnant women, Breastfeeding women, Congestive heart failure NYHA class III or IV, Conditions which increase the risk of severe antiarrhythmic drug side effects, Severe associated conditions.
Ultrasound Morphometric and Cyto/Histological Combined Pre-operative Assessment of Inguinal Lymph Node Status in Women With Invasive Vulvar Carcinoma

Vulvar cancer is a rare and very aggressive cancer, mainly spreading through lymphatics, in which the preoperative evaluation is critical to address surgery between sentinel node biopsy or radical groin lymphadenectomy.

In the absence of clearly an specific guidelines on preoperative vulvar cancer assessment, the investigators decided to better investigate the role of ultrasound in groin nodes evaluation through the study 10 sonographic features of suspicion for nodal involvement:

* globular shape (loss of the normal elliptical form)
* long/short axis ratio
* cortical/medulla ratio
* cortical focal bulging or thickening
* hilum anomalies
* inhomogeneous echostructure
* intranodal deposits
* extracapsular spread
* grouping
* vascularization

The standard of comparison is histopathology.

The prospectively evaluation of these parameters will be obtained on the enrolled patients.

The investigators also provided the retrospective review - by specialized staff - of ultrasound images collected in archives associated with information relating to the cyto/histological procedures (performed in case of suspicious lymph nodes) in patients who underwent surgical treatment in the last five years at the study center.

Eligibility Criteria:
Inclusion Criteria:

* Invasive vulvar cancer (all infiltrating histotypes)
* Age \>18 years

Exclusion Criteria:

* patient unable to follow the study procedures
* patient with major depressive disorder
Validation of the Chinese ObsQoR-11

Investigation of post-cesarean recovery among Taiwanese pregnant women.

Improving postpartum quality of recovery is important particularly for women undergoing cesarean delivery. This is because cesarean delivery is associated with significant postoperative pain and risks of anesthesia-related adverse effects. To improve the quality of recovery after a cesarean delivery, the first step is to find out the most relevant perioperative factors.

In response to this problem, experts including anesthesiologists, obstetricians and midwives from University College London Hospital, Royal Free Hospital, London as well as Stanford University established a set of 11-item questionaire related to postpartum recovery, namely the Obstetric Quality of Recovery-11 score (ObsQoR-11), with a total score of 110. The latest systemic review in 2020 also confirmed that this questionnaire is the best option for recovery assessment after cesarean delivery. However, for women undergoing cesarean delivery in Taiwan, it is still unknown whether this questionnaire is representative or not. Therefore, this study aims to include women undergoing elective cesarean delivery from three hospitals in Taiwan.

Eligibility Criteria:
Inclusion criteria

1. age\>= 20 yr
2. elective cesarean delivery

Exclusion:

emergent surgery
Optimal Treatment for Coronary Drug Eluting Stent In-stent Restenosis

The aim of this open label, randomized study is to compare the safety and efficacy of three different methods to handle coronary drug eluting stent (DES) in-stent restenosis (ISR).

These are the:

* Magic Touch - sirolimus coated balloon
* Emperor - paclitaxel and dextran coated balloon
* Xience - chromium-cobalt everolimus eluting stent


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted for intervention of drug eluting stent restenosis
* Restenosis suitable for all three treatment arms as per 'instructions for use' of the devices
* Optional enrollment in the optical coherence tomography sub-study (10-20% of patients)

Exclusion Criteria:

* Patients undergoing coronary angiography after sudden cardiac death
* Pregnant or nursing
Oral Calcium in Pregnant Women With Hypertension

To determine of providing calcium supplementation to women with pre-existing hypertension reduces the level of blood pressure, requirement for antihypertensive drugs, and incidence of pre-eclampsia.

BACKGROUND:

Maternal and fetal complications are more likely to occur in pregnant women with preexisting hypertension. Alterations in calcium metabolism, the renin angiotensin system, and intracellular free calcium concentration have been identified in this high risk population. The beneficial effects of calcium supplementation on blood pressure and the incidence of superimposed pre-eclampsia may be due to correction of the hormonal and cellular basis for vasoconstriction. The trial sought to prove that oral calcium lowered parathyroid hormone, reduced intracellular free calcium, and decreased vascular endothelin production, resulting in vasodilation and compensatory stimulation of the renin-angiotensin system.

DESIGN NARRATIVE:

Randomized. Double blind. In this observational study, subjects were assigned to two grams of supplemental elemental calcium or to placebo at 13 to 15 weeks gestation. The trial determined the effect of oral calcium supplementation on: the level of blood pressure; the need for antihypertensive drugs; forearm and peripheral vascular resistance; the incidence of maternal complications, including pre-eclampsia and eclampsia; and plasma levels of vitamin D3, ionized calcium, parathyroid, renin activity, angiotensin II, endothelin, nitrate/nitrite, prostacyclins, and intracellular calcium concentrations in lymphocytes and platelets. These variables were measured prior to randomization and every two months throughout pregnancy and the postpartum. Support ended in July 1999.

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:
Pregnant women with chronic hypertension.
Assessment of Pain in Newborns and Older Infants (Infant Pain Assessment Study =

Pain assessments in non-verbal, critically ill infants represent an important clinical challenge. Older children or adults can easily express their pain, but infants lack that capability. They frequently experience repetitive acute pain during routine ICU care, but their analgesic management flounders on the horns of a dilemma: (a) failure to treat infant pain leads to immediate clinical instability and potentially long-term physical, behavioral, and cognitive sequelae, vs. (b) strong analgesics may increase risks for medical complications and/or impaired brain growth. Bedside nurses currently assess pain using pain scores, before taking action to ameliorate pain. Pain scores increase nursing workload and provide subjective assessments, rather than objective data for evaluating infant pain. Consequently, infants exposed to skin-breaking procedures, surgery, or other painful conditions often receive variable and inconsistent pain management in the ICU. The investigators aim to develop a multimodal pain assessment system, using sensor fusion and novel machine learning algorithms to provide an objective measure of pain that is context-dependent and rater-independent. This will enhance the quality of pain management in ICUs and allow continuous pain monitoring in real-time.


Eligibility Criteria:
Inclusion Criteria:

* 1. All infants less than 6 months of corrected chronological age. 2. Infants admitted to the participating ICUs at LPCH (NICU, PICU, CVICU). 3. Require an acute painful procedure for routine clinical care.

Exclusion Criteria:

1. Newborns with birth trauma, intrapartum asphyxia (5-minute Apgar Score \<4 or cord pH \< 7.01), fetal growth restriction (birth weight \< 5th percentile for gestation), congenital anomalies or metabolic disorders, or any kind of brain injury.
2. Newborns born to mothers with a history of heavy smoking or drug abuse (alcohol, cocaine, ketamine, heroin/other opiates) or psychiatric drugs used during this pregnancy.
3. Newborns and infants requiring positive pressure ventilation using a face mask (BiPAP) or endotracheal tube (conventional or high-frequency ventilators).
4. Newborns and infants receiving continuous infusions of opioid drugs (morphine, fentanyl, others) and nerve blocks or neuraxial analgesia affecting the site of the invasive procedure during the 24 hours prior to study entry. (Note: Infants receiving intermittent opioids or non-opioid analgesics (acetaminophen, ibuprofen, ketorolac, others) WILL NOT be excluded).
5. Newborns and infants with facial anomalies, injuries or other pathologies affecting the facial area.
The Effects of Observer Presence and Type on Patients' Perception of Exercise After Bone Tumor Resection-A Qualitative Study

The primary aim of the study is to investigate the effects of supervised exercise, telerehabilitation and home-based exercise on patient perception in patients who have undergone bone tumor resection. The secondary aim of the study is to identify the barriers to starting exercise in these patients.

An exploratory-descriptive qualitative study will be conducted. There will be three groups in the study with each of them will consist of ten participants. Within the scope of the study, each group will perform a similar exercise program, 2 sessions a week, for 6 weeks, in one of the 3 groups below; Group 1: Exercising under the supervision of a face-to-face physiotherapist, Group 2: Exercise under the observation of the physiotherapist via video-conference (telerehabilitation), Group 3: Exercising in the absence of the observer (home based exercise program).

The exercises to be applied to the groups will include breathing exercises, passive range of motion exercises within the pain limit for the joints associated with the surgery area, and strengthening exercises for the non-surgical areas.

Semi-structured focus group interviews will be held with the participants twice, before and after the 6-week exercise program. In the semi-structured focus group interviews, the same questions will be asked to all participants and the verbal answers to these questions will be recorded with voice recorders. Compared to taking notes by hand; It will be preferable to record the conversation with a voice recorder because it has advantages such as recording all the interviews and allowing the interviewer to focus on the interview. In the pre-exercise interview, questions will be asked to determine the patient's views about exercises and the barriers to starting the exercise. In the interview held at the end of the exercise program, questions will be asked to learn the views/perceptions of the patients about the results of the exercise program. Thematic analysis method will be used in the evaluation of the data.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged between 18 and 65,
* Individuals without communication problems,
* Individuals who have been diagnosed with a bone tumor for the first time and who have undergone resection surgery

Exclusion Criteria:

* Uncontrollable arrhythmia and/or hypertension
* Presence of advanced sensory deficit
* Visual and hearing problems
* Not having sufficient communication skills (Mini Mental Test score below 24 points)
* Patients undergoing head and neck bone resection