cyrilzakka/clinical-trials huggingface dataset:
School Inner-City Asthma Intervention Study (SICAS-2)

The investigators goal is to determine the efficacy of school/classroom based environmental intervention in reducing asthma morbidity in urban schoolchildren.

Our proposal builds upon our established, successful school-based infrastructure to determine whether a school/classroom intervention will efficiently and effectively improve asthma morbidity by reducing these exposures. Our goal is to determine the efficacy of school/classroom based environmental intervention in reducing asthma morbidity in urban schoolchildren. Our central hypothesis is that reducing classroom/school exposure to mouse allergen, mold, and particulate pollutants will decrease asthma morbidity in students with asthma. The investigators plan to test this hypothesis in an intervention study of 300 elementary students with asthma from multiple classrooms in inner-city elementary schools. Our clinical trial aims are to determine the effectiveness of a school/classroom based environmental intervention (school integrated pest management and classroom air purifying filter units within these schools) to reduce asthma morbidity. Our mechanistic aim is to test the hypothesis that effects of school/classroom-based environmental interventions on symptoms/other measures of asthma control occur through changes in gene methylation or expression in pathways (and secondarily, in genes) relevant to airway function and asthma. This will expand our understanding of asthma immunopathogenesis and create opportunities to identify potential novel targets for asthma therapy.

Eligibility Criteria:
Inclusion Criteria:

* grades K-8 with asthma attending sampling/intervention schools

Exclusion Criteria:

* moving schools
Investigating the Effect of Obesity on Eosinophil Recruitment in Human Adipose Tissue

Researchers are trying to better understand the relationship between inflammation in adipose tissue (AT) and insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

* Adults ages 30-50 years
* Non-smokers
* Lean subjects with a BMI of 25 or less, gender specific normal body fat,
* Obese, non-diabetic subjects with a BMI between 30 and 50 and taking no medications affecting glucose metabolism or lipid metabolism
* subjects scheduled for an elective laparoscopic or laparotomy abdominal surgery

Exclusion Criteria:

* Receiving corticosteroid therapy or have a history of asthma, COPD or atopic syndrome
* taking any biologic treatment for any autoimmune disorder
* Taking any leukotriene receptor antagonist acting medications (ex. Montelukast)
* smoking
Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 1

In the stage of registration study, our purpose is to find out the safety range of activated coagulation time level in cerebral aneurysm and arteriovenous malformations with hybrid operation.

This study is divided into anticoagulation program in cerebral aneurysm with hybrid operation and anticoagulation program in cerebral arteriovenous malformations with hybrid operation two parts, and each part divide into two stage, on the stage of registration study. This study is a multi-center, single-blind, prospective cohort study. Record the patient's intraoperative activated coagulation time Changes in detail, to observe the effect of activated coagulation time maintenance level on hemorrhage event rate of Intraoperative and postoperative 48 hours, purpose to find out the safety range of activated coagulation time level in cerebral aneurysm and arteriovenous malformations with hybrid operation. On the stage of randomized controlled study. This study is a multicenter, single-blind, prospective, randomized controlled study. Patients is divided into intraoperative standard dose group of Heparin Sodium and low dose group of Heparin Sodium randomly. To observe the effect of different anticoagulation regimens on activated coagulation time safety coverage rate during surgery, and finally develop a scientific and effective intraoperative anticoagulant therapy program.

Eligibility Criteria:
Inclusion Criteria:

1.All patients undergoing hybird surgery.

Exclusion Criteria:

1. Poor general condition , severe primary disease, surgical contraindications
2. Patient or family refused surgery
3. Fusiform aneurysm,Traumatic aneurysm,Infectious aneurysms
4. Combined with other hemorrhagic cerebrovascular disease
5. Combined with malignant brain tumor
6. Perinatal, Pregnancy
7. Patients unwilling to participate in the trial
Ecofisio, a Mobile Application for Assessment and Diagnosis Using Ultrasound Imaging for Undergraduate Health Science Students

The new called "Generation Z" is starting to reach college age. They have adopted technology and create a deep dependence on it, becoming more drawn to the virtual world. M-learning has experienced a huge expansion in recent years in both, medical context and medical and health's sciences education. Ultrasound is an important diagnosis technique in physiotherapy, especially in sports pathology. m-Learning environments could be a useful tool for improve the comprehension of ultrasound concepts and the acquisition of professional competencies. The purpose of this study was to evaluate the efficacy and the use of an interactive platform accessible through mobile devices (ECOFISIO) using ultrasound imaging for the development of professional competencies in the evaluation and diagnosis of sports pathologies.

Participants were 110 undergraduate students enrolled in two groups of this randomized controlled multicentre study: a control group (traditional learning) and experimental group (ECOFISIO mobile application). All participants were assessed both theoretically and by means of the Objective Structured Clinical Examination (OSCE) exams.


Eligibility Criteria:
Inclusion criteria:

* To have anatomy and biomechanics previous knowledge.
* To be enrolled in any required subject.
* To have basic ability to use a mobile application.
* To have a smartphone with Internet Access (Android Operating System).

Exclusion criteria:

- To have received any previous training in ultrasound imaging and managing.
A Phase 1/2 Study to Evaluate ALN-KHK in Overweight to Obese Healthy Volunteers and Obese Patients With T2DM

To evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of ALN-KHK and to evaluate the safety, tolerability, efficacy, PK and PD of multiple doses of KHK.


Eligibility Criteria:
Inclusion Criteria:

* Stable euthyroid status (no known changes in thyroid function; stable hormone replacement for at least 4 months) at screening
* Part A: body mass index (BMI) ≥27 kg/m\^2 and ≤34.9 kg/m\^2
* Part B: BMI ≥30 kg/m\^2 to ≤39.9 kg/m\^2, confirmed diagnosis of T2DM, and an HbA1c ≥7.5% to \<10%
* Part B: Confirmed T2DM diagnosis

Exclusion Criteria:

* Parts A and B: has received an investigational agent within the last 30 days
* Part A: History of Type 1 or Type 2 diabetes
* Part B: History of Type 1 diabetes
A Comparison of Paclitaxel-based Three Regimens Concurrent With Radiotherapy for Patients With Local Advanced Esophageal Cancer

The purpose of this study is to determined the best scheme in paclitaxel and cisplatin，paclitaxel and fluorouracil，paclitaxel and carboplatin concurrent with radiotherapy for patients with local advanced esophageal Squamous Cell Carcinoma.


Eligibility Criteria:
Inclusion criteria

To be eligible for this study, patient must fulfill all of the following criteria:

1. Histologically confirmed esophageal squamous cell carcinoma
2. Clinical stages II, III or IVa based on the 6th UICC-TNM classification
3. No prior treatment of chemotherapy, radiotherapy or surgery against esophageal cancer, except for non-curative resection by EMR/ESD.
4. Aged 18-75 years
5. Adequate organ functions

   1. White blood cell (WBC) ≥3×109⁄L
   2. Absolute neutrophil counts (ANC) ≥1.5×109⁄L
   3. Hemoglobin (Hb) ≥10g⁄dl
   4. Platelet (Plt) ≥100×109⁄L
   5. Total bilirubin \<1.5 upper limit of normal (ULN)
   6. Aspartate transaminase (AST) ≤2.5 ULN
   7. Alanine aminotransferase (ALT) ≤2.5 ULN
   8. Creatinine ≤1.5 ULN
6. ECOG PS of 0-2
7. Life expectancy ≥3 months
8. Written informed consent

Exclusion criteria Patients fulfilling any of the following criteria are ineligible for this study.

1. Esophageal perforation or hematemesis
2. Synchronous or metachronous malignancies (except for cutaneous (non-melanomas) carcinoma, thyroid papillary carcinoma, phase I seminoma or cervical carcinoma in situ curatively treated and disease free for a minimum of 3 months)
3. Received thoracic, abdominal or craniocerebral surgery within 30 days
4. Enrolled in other clinical trials within 30 days
5. Unstable angina and/or congestive heart failure requiring hospitalization within 6 months
6. Severe psychiatric disease
7. Pregnancy, lactation or unwillingness to adopt contraception
8. Drug addiction
9. Acquired immune deficiency syndrome (AIDS) based upon current CDC definition
10. Patients with hearing impairment or sensory-motor neuropathy of WHO grade \> 1
11. History of radiotherapy in the planning area
12. Other ineligible conditions according to researchers
Efficacy and Safety Of Xeloda as Sequential Adjuvant Therapy After Chemotherapy in Breast Cancer

Select 600 cases of women with breast cancer of triple negative or Her-2 positive or with more than 4 axillary lymph node metastasis. All the patients were accepted the chemotherapy of Anthracycline and/or Taxane. Divide them into two groups randomly. Then the experimental group will be treated with Xeloda(1000mg/m2,orally,2 times/day) for six cycles (21 days/cycle,each taking two weeks suspending for one week) as Sequential Adjuvant Therapy. And the control group will not receive any adjuvant therapy.Finally the investigators will assess the 5-year disease-free survival, 5 years and 10-year overall survival and safety of using medications.

The investigators will select 600 cases of women with breast cancer of triple negative or Her-2 positive or with more than 4 axillary lymph node metastasis. All the patients were accepted the chemotherapy of Anthracycline and/or Taxane. Divide them into two groups randomly. Then the experimental group will be treated with Xeloda(1000mg/m2,orally,2 times/day) for six cycles (21 days/cycle,each taking two weeks suspending for one week) as Sequential Adjuvant Therapy. And the control group will not receive any adjuvant therapy.Finally the investigators will assess the 5-year disease-free survival, 5 years and 10-year overall survival and safety of using medications.

Eligibility Criteria:
Inclusion Criteria:

1. Karnofsky ≥ 70
2. Provision of informed consent
3. Pathological confirmation of breast cancer and exclusion of other metastases.
4. Pathological confirmation of triple negative or Her-2 positive or with more than 4 axillary lymph node metastasis
5. The patients have finished the chemotherapy of Anthracycline and/or Taxane.And it's no more than 28 days from accepting the last chemotherapy.
6. Laboratory criteria:

PLT ≥ 100\*109/L WBC ≥ 4000/mm3 HGB ≥ 10g/dl GOT,GPT,ALP ≤ 2\*ULN TBIL,DBIL,CCr ≤ 1.5\*ULN

Exclusion Criteria:

1. Pregnant or lactation woman
2. Bilateral breast cancer, inflammatory breast cancer or carcinoma in situ
3. Accepted neoadjuvant treatment including chemotherapy, radiotherapy and endocrine therapy
4. History of organ transplantation
5. With mental disease
6. With severe infection or active gastrointestinal ulcers
7. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes
8. Disease-free period of other malignant tumor is less than 5 years(except cured basal cell skin cancer and cervical carcinoma in situ)
9. With heart disease
10. Experimental drug allergy
Effect of Dynamic Sitting on Pain Development

Worksite based prolonged static sitting postures can cause musculoskeletal pain. While the development of pain increases due to the constant growth of digitalization at work, numerous interventions to reduce prolonged sitting periods have been created. The effects of such interventions have not yet been properly examined. Thus, the "DynSit-Pain" project was initiated to investigate the influence of dynamic sitting on the pain development of pain developers in office environments.

This clinical investigation is a prospective, randomized, controlled, counter-balanced, two-arm field study investigating the effect of dynamic sitting on musculoskeletal pain in office workers classified as pain developers.

The study consists of a pre-screening visit and 4 assessment days / visits. During this pre-screening visit and after proving the study eligibility (inclusion / exclusion criteria), half of the study participants will randomly be allocated to one of the two study arms. Depending on the arm allocation, participants will receive a dynamic (= intervention) or static (= control) office chair for 6 weeks. After a wash-out of at least 4 weeks the 6-week intervention resp. control will be switched. The randomization will be realized with opaque envelopes.

Overall participants will execute the identical assessments within the control and the intervention chair group. The wash-out phase between the control and the intervention periods will ensue identical baseline conditions for both chairs. The overall duration of study participation amounts to 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* People aged between 18 and 65 years
* People classified as pain developers (e.g., increase of pain of 10 mm on a 100 mm paper based visual analogue scale) determined by pre-screening
* Office workers
* Employment status: \> 30 h / week
* Sufficient German language skills (minimum B2 level)
* Table height of at least 63 cm at the main workplace

Exclusion Criteria:

* Physical or mental limitations that aggravate dynamic sitting or using the interventional chair (e.g., wheel chair users, vestibular dysfunctions)
* Pregnancy
* Working in sitting posture for less than 20 hours per working week in the main workplace.
* Bodyweight over 110 kg and a body height over 195 cm
* Regular therapy or medication for pain
Lymphocyte Count as a Sign of Immunoparalysis and Its Correlation With Nutritional Status in Septic Pediatric Patients

Participants were classified as normal or malnourished according to anthropometric measures. Serum albumin and zinc were recovered on the 1st and 7th days of hospitalization. Lymphocyte count was also recorded on the 1st and 7th days.

The investigators enrolled 14 consecutive patients with sepsis. Patients were classified as normal or malnourished according to anthropometric measures. As an additional evaluation of nutritional status, serum albumin and zinc were recovered on the 1st and 7th days of hospitalization. Lymphocyte count was also recorded on the 1st and 7th days. Investigators correlated nutritional status with lymphocyte count and zinc dosage.

Eligibility Criteria:
Inclusion Criteria:

* septic patients

Exclusion Criteria:

-
1C70 Feasibility Study

The objective of this study is to characterize the extend of 1C70 meeting the amputees needs in comparison with their everyday and a comparator foot, in regards of daily activities, mobility and balance, as well as quality of life and pain.


Eligibility Criteria:
Inclusion Criteria:

* Person is at least 18 years old.
* Person is a unilateral transtibial amputee with stabilized residual limb.
* Person is a K3 ambulator based on Medicare Functional Classification Level (MFCL) .
* Person has at least 6 months experience in walking with a prosthesis.
* Person is using an energy storage and return (ESR) foot as their primary everyday foot
* Person has a foot size between 22 and 30.
* Person weights with a prosthesis between 50 and 125 kg (foot size 26 - 30), or between 45 and 100 kg (foot size 22 - 25).
* Person wears a prosthesis daily and ≥ 8 hours/day.
* Person is able to walk at least 500 m without having to make a break.
* Person is willing and able to independently provide informed consent.
* Person is willing to comply with study procedures.

Exclusion Criteria:

* Person is pregnant.
* Person is using a hydraulic foot as their primary everyday foot.
* Person is using a sport foot (e.g., Fillauer AllPro, Ottobock Challenger, Össur Flex-Foot Cheetah) as their primary everyday foot.
* Person is using an ESR foot with an integrated vacuum pump (e.g., Ottobock 1C62 Triton Harmony).
* Person has conditions that would prevent participation and pose increased risk (e.g., unstable cardiovascular conditions that preclude physical activity such as walking).
* Person falls ≥ once a week due to the reasons that are not related to prosthesis (e.g., problems with vestibular system).
* Person is not available for study visits during planned study duration.
* Person is participating in another study or intends to participate in another study during this study´s duration.
* Person cannot personally provide their consent.
Effect of Automatic Recruitment Maneuver on Peroperative Lung Mechanics of Obese Laparoscopic Abdominal Surgery Patients

This study aims to demonstrate the effects of automatic recruitment maneuver on peroperative lung mechanics of obese patients undergoing laparoscopic abdominal surgery.

128 obese patients undergoing abdominal laparoscopic surgery are randomly going to be assigned to automatic recruitment maneuver group and no recruitment maneuver group (control group). Both groups are going to be taken to the operating table. Electrocardiography (ECG), noninvasive blood pressure (NIBP), pulse oximeter and peripheral oxygen saturation (SpO2) and post-intubation end-tidal carbon dioxide (EtCO2) and train of four (TOF) monitoring will be performed. Then, general anesthesia induction procedure will be started. Following intubation, patients will be ventilated according to the ideal weight within the scope of intraoperative protective ventilation strategy and in pressure-controlled ventilation (PCV) mode. Then, automatic recruitment maneuver will be applied to the recruitment group twice, after insufflation and desufflation. It will not be applied to the control group. During recruitment maneuver, PEEP (Positive end-expiratory pressure), where dynamic compliance is measured highest, will be the ideal PEEP (Positive end-expiratory pressure) for the patient, and PEEP (Positive end-expiratory pressure) will be adjusted at this value after recruitment. If MAP (mean arterial pressure) is \<60 mmHg during the maneuver, the maneuver will be terminated and these patients will be excluded from the study. Respiratory mechanics for both groups (peak pressure, plateau pressure, driver pressure, static compliance, dynamic compliance, EtCO2) and hemodynamic parameters (heart peak, mean arterial pressure, SpO2) at 5 different times (T1: post intubation; T2 : after insufflation; T3: 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver) will be recorded. Throughout the surgery, insufflation pressure will be kept as 10-13 cmH20. At the end of the surgery, the anesthesia maintenance of all patients will be terminated and the routine wake-up phase will be initiated. Creatinine values and hourly urine outputs of all patients routinely monitored at the postoperative 24th hour will be recorded on the case follow-up form.


Eligibility Criteria:
Inclusion Criteria:

1. Patients between the ages of 18 and 65
2. Body mass index (BMI)\> 30 patients undergoing laparoscopic abdominal surgery
3. ASA (American Society of Anesthesiologists) 2-3 patients

Exclusion Criteria:

1. Smokers
2. Patients with previous abdominal surgery
3. Patients with obstructive / restrictive lung disease,
4. Patients with coronary artery disease, heart failure
5. Patients with chronic kidney failure
Preventing Seroma Formation After Axillary Lymph Node Dissection for Breast Cancer by Early Vacuum Assisted Closure

Axillary dissection is the standard treatment for breast cancer patients with positive nodes. However, seroma formation after axillary dissection remains the most common early complication to breast cancer surgery. It can delay the initiation of adjuvant therapy, predispose to wound infection, delay wound healing and has also been linked to arm lymphoedema. Based on some studies and our experience that vacuum assisted closure （VAC）is effective in complex wound failures following axillary dissection and groin dissection, we use VAC to prevent seroma formation after extensive axillary dissection. This study is aimed to evaluate the efficacy, safety and economics benefits of early VAC application on postoperative complications and wound healing after extensive axillary dissection in comparison to conventional suction drain.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* patients diagnosed with breast cancer, receiving modified radical mastectomy and axillary dissection；
* Body Mass Index ≥28；
* drainage volume within the first 48 hours is more than 200 mL.

Exclusion Criteria:

* Subjects with coagulation disorders shown by exceeding the normal range of any of following: prothrombin time (PT), Quick, activated partial thromboplastin time (aPTT), fibrinogen level, or thrombocytes.
* Subjects having previously had axillary surgery,
* Subjects having undergone irradiation therapy to the axillary tissue
* Subjects having ever received chemotherapy before the surgery,
* Subjects with known hypersensitivity to components of the surgical sticky membrane
PD-1/PD-L1 Inhibitors and Anti-angiogenic Therapy Combined With/Without TACE/HAIC in Patients With BCLC B/C Hepatocellular Carcinoma Beyond Up-to-7

This is a retrospective study that retrospectively included patients with intermediate and advanced HCC beyond up to seven who received first-line treatment with PD-1/PD-L1 inhibitors and anti-angiogenic agents combined with/without TACE/HAIC from January 01, 2019 to December 31, 2023 in the Department of Hepatic Oncology and Department of Liver Cancer Surgery, Zhongshan Hospital, Fudan University.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have been diagnosed with advanced hepatocarcinoma (HCC), confirmed histologically or clinically.
* Patients with Barcelona (BCLC) stage B and C beyond up to seven;
* Have not received any prior systemic therapy for HCC (including: chemotherapy, molecular targeted therapy, immunotherapy);
* Receiving only post-marketing PD-1/PD-L1 inhibitors in combination with anti-angiogenic agents (including, but not limited to, drugs containing hepatocellular carcinoma indications);

  \*The interval between the first use of PD-1/PD-L 1 inhibitors and the use of anti-angiogenic drugs is ≤ 1 week
* TACE was performed within 1 month prior/after the first PD-1/PD-L 1 inhibitor/antiangiogenic drug treatment;
* TACE treatment followed by at least 1 cycle of combination therapy, including: cTACE and DEB-TACE;
* There is at least 1 measurable lesion in the liver according to RECIST v1.1 criteria

Exclusion Criteria:

* Cholangiocellular carcinoma, mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or hepatic fibrous laminar carcinoma that has been pathologically/histologically confirmed;
* Patients who do not meet the above definition of combination therapy;
* Patients had malignant tumors other than HCC within 5 years prior to enrollment (except cured limited tumors, including cervical carcinoma in situ, basal cell carcinoma of the skin, and prostate carcinoma in situ)