cyrilzakka/clinical-trials huggingface dataset:
Do Elastic Abdominal Binders Reduce Post Operative Pain and Blood Loss?

This is a pilot study investigating the use of abdominal binders after cesarean sections. The researchers are testing whether elastic abdominal binders improve postoperative pain control and reduce postoperative blood loss. Blood loss and pain control are both concerns after giving birth. It is hoped that the use of an abdominal binder after giving birth will provide a non-pharmacologic way to to reduce blood loss and manage pain.


Eligibility Criteria:
Inclusion Criteria:

* Cesarean section at term (at least 39 weeks gestation) scheduled in advance
* Singleton gestation confirmed by ultrasound in the current pregnancy
* Body mass index 20-40 kg/m2 (at first prenatal visit or pre-pregnancy)
* None of these pregnancy complications in the current pregnancy:

  1. bleeding disorder or use of anticoagulants other than low-dose heparin
  2. abnormal placenta (placenta previa or accrete)
  3. Preoperative hemoglobin less than 10 mg/dL
  4. Chorioamnionitis (intrauterine infection)
* No chronic pain syndrome (defined as participating in formal chronic pain management within the past year)
* Able to read English and understand spoken English

Exclusion Criteria:

* Onset of labor prior to time when the cesarean was scheduled
* Complications during performance of cesarean or discovered during cesarean:

  1. placenta accreta, increta, or percreta
  2. vasa previa
  3. cesarean hysterectomy required for severe hemorrhage
  4. organ damage during cesarean (cystotomy, enterotomy, ureteral injury)
Clinical Study of ctDNA and Exosome Combined Detection to Identify Benign and Malignant Pulmonary Nodules

This study through the detection of EGFR、ALK、ROS1、KRAS、HER2、BARF、NTRG1 seven ctDNA and exosome RNA in the blood and alveolar lavage of lung nodules patients and heavy smoking healthy population. If the results of ctDNA test is positive, the target nodule is malignant; if the reaults of ctDNA teste is negatie but exocome RNA is positive, the target nodule is also malignant. If the results of both tests are negtive, the target nodule is recognized as benign. The purpose is study the sensitivity, specificity and diagnostic accuracy of ctDNA and exosome combined detection in the identification of benign and malignant pulmonary nodules. Besides, the diagnostic efficacy of different specimens including blood and alveolar lavage in the identification of benign and malignant pulmonary nodules is also studied.

Pulmonary nodules are round or irregular shape lesions with a diameter of less than or equal to 3cm. 10% lung nodules will become lung cancer, and lung cancer is evolved from small nodules.

Liquid biopsy is an effective and noninvasive means to assist in the early diagnosis of lung cancer, including circulating tumor cell、exosome and ctDNA detection. CtDNA is used to detect DNA fragments relesased to plasma by cracking or apoptotic tumor cells. Exosomes are derived from living cells, and researchers found that exosome nucleic acid detection of living cells may be closely related to the dynamic development of tumors.

This study through the detection of EGFR、ALK、ROS1、KRAS、HER2、BARF、NTRG1 seven ctDNA and exosome RNA in the blood and alveolar lavage of lung nodules patients and heavy smoking healthy population. If the results of ctDNA test is positive, the target nodule is malignant; if the reaults of ctDNA teste is negatie but exocome RNA is positive, the target nodule is also malignant. If the results of both tests are negtive, the target nodule is recognized as benign. The purpose is study the sensitivity, specificity and diagnostic accuracy of ctDNA and exosome combined detection in the identification of benign and malignant pulmonary nodules. Besides, the diagnostic efficacy of different specimens including blood and alveolar lavage in the identification of benign and malignant pulmonary nodules is also studied.

Eligibility Criteria:
Inclusion Criteria:

Age ≥18 years old; The diameter of pulmonary lesions is 0.5-3cm in chest CT within 3 months; Healthy patients in normal control group had a smoking index ≥400; Patients who are eligible and intend to bronchoscopy.

Exclusion Criteria:

The patient received blood transfusion within 1 month； Patients suffer from autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, sjogren's syndrome, etc； Patients with cardiopulmonary dysfunction or other taboos, not suitable for bronchoscopy; Patients refused to participate in this clinical trial; The investigator considerates that the patient has other conditions that is unsuitable for this clinical trial.
Study of Default Options in Advance Directives

Default options represent the events or conditions that are set into place if no alternatives are actively chosen. The setting of default options has well-established effects on a broad range of human decisions, but its influence on patients' preferences for end-of-life care is only beginning to be understood.

This is a 3-armed randomized clinical trial in Veterans at high risk for critical illness, assessing the impact of Advance Directive (AD) forms framed with different default options. The central goals are to assess how default options in ADs influence the end-of-life care choices made by patients at risk for critical care, and these patients' hospital and ICU utilization.

The investigators hypothesize that setting defaults in real ADs will increase the proportion of Veterans selecting comfort-oriented plans of care, decrease selections of life-extending therapies such as mechanical ventilation and dialysis, and reduce the proportion of time during follow-up that Veterans spend in the hospital and/or ICU, without affecting patient satisfaction with end-of-life care planning.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Chronic Obstructive Pulmonary Disease (COPD) with severe or very severe airflow obstruction on pulmonary function testing and or receiving or eligible to receive long-term oxygen therapy AND/OR
* Idiopathic Pulmonary Fibrosis (IPF) AND/OR
* Other interstitial lung disease without curative therapy AND/OR
* Any stage 3B or 4 solid tumor AND/OR
* Congestive Heart Failure (CHF) either New York Heart Association NYHA) class IV or NYHA class III plus 1 hospitalization in the past year
* No previously signed advance directive in the medical record
* Neither listed for nor considering lung or heart transplantation
* High anticipated risk for critical illness in the next 2 years based on clinical judgment
* Interest in thinking about filling out an Advance Directive

Exclusion Criteria:

* Diseases for which life-extending medical therapies may be available
* Inability to speak and/or read English proficiently
* New clinic patients meeting the clinic provider for the first time
* Patients being actively evaluated or already listed for transplants
* Patients already having an AD
* Cognitive impairment necessitating proxy consent
Primary Versus Deferred Ureteroscopy for Calculus Anuria in Children

To evaluate the role of both primary and deferred URS in the management of calculus anuria concerning the feasibility, clinical outcome, and cost-effectiveness in children in a comparative study

Thirty group B (30) patients will be admitted to do urinary drainage through the insertion of a JJ stent or percutaneous nephrostomy (PCN) at first , then a deferred URS will be done children will undergo primary URS( group A ) and in. Ureteral dilatation will be done when the stone size exceeds 10 mm to facilitate the extraction of the fragments. Ureteroscopic lithotripsy will be done using a 6.5:7.5 Fr semi-rigid ureteroscope and holmium laser. The ureteric stent will last for one week after lithotripsy. Postoperatively, the patients in both groups will monitored for post obstructive diuresis, fever, hematuria, and extent of renal function improvement.

Eligibility Criteria:
Inclusion Criteria:

* Children ˂12 years with calculus anuria.
* Clinically stable (serum creatinine \< 3.5 mg/dl, blood urea \< 100 mg/dl,serum potassium level \< 7 milliequivalent /L and /or ph of blood \> 7.1)
* All the patients free of sepsis.

Exclusion Criteria:

* Unstable children (serum creatinine ≥ 3.5 mg/dl, blood urea ≥ 100 mg/dl, serum potassium ≥ 7 milliequivalent/l, and/or blood pH ≤ 7.1, signs of acidosis, sepsis, or fluid retention).
* Children with underlying urological structural abnormalities
Online Videos and New Feeding Content to Enhance a Current EFNEP Program

The goal of this study is to further increase the impact of a validated and widely-used Eating Smart • Being Active EFNEP curriculum by teaching parents responsive feeding practices resulting in the development of healthier patterns of child eating behavior and food intake. Additionally, the effectiveness of two delivery strategies for adding feeding video-based content will be examined (in-person versus online lessons).

During Phase I of the project (first two years), the leadership team composed of both research and extension investigators will work with the media production team to edit the SEEDS videotapes to meet the needs of the current project and to develop the website and activities for use in the online condition. Phase II (second three years) will be a large scale evaluation of this program. In this phase, classes of EFNEP participants in Colorado and Washington will be randomly assigned to one of three conditions: 1) Eating Smart • Being Active alone (control); 2) Eating Smart • Being Active plus feeding videos at the weekly EFNEP sessions, plus facilitated group discussion (in-person); or 3) Eating Smart • Being Active plus online videos and activities, (online). Pre- and post-program assessments, 6- and 12-month follow ups will be conducted to assess responsive feeding, providing structure, food exploration, child eating behaviors, parent knowledge, and child dietary intake. Child dietary intake will be obtained on a sub-sample of 90 participants. In Phase III, the investigators will begin dissemination.

A total of 543 participants were recruited in five locations to participate in the project: 262 from three counties in Colorado and 281 from three counties in Washington (English and Spanish participants). A total of 4 to 10 mothers were recruited for each group. After recruitment, groups were randomly assigned to the three conditions ensuring a relatively equal number of participants per condition.

Data from children who have any kind of food allergies or diabetes or are on special diet will be excluded from the analyses.

To ensure program fidelity, program educators will complete implementation checklists, and 20% of the sessions will be attended by an additional grant staff member to conduct implementation observations and assess participant engagement. Detailed records of participant attendance will be collected to assess dosage effects and attrition. All assessments will be conducted by grant project staff blind to the group status of the participants. Retention of participants will be maximized using strategies such as obtaining multiple phone numbers for each family; obtaining external contact information for siblings and close friends; sending interim reminders with the goal of fostering contact should the family move; and phone calls, emails or letters between data collection points to each family.

Eligibility Criteria:
Inclusion Criteria:

* Parents who attend EFNEP programs in the states of WA and CO.

Exclusion Criteria:

* Parents with children younger than age 2 and older than age 8 will be excluded.
PRe-Operative Gefitinib in Resectable EGFR Mutation Positive Lung Cancer With Sector Sequencing for Biomarker Discovery

This is a pharmacodynamic study to evaluate the effect of gefitinib as induction therapy for patients who have resectable, Epidermal growth factor receptor (EGFR) sensitizing mutation lung cancer.

Selected patients will receive 4 weeks of gefitinib before surgery. A Positron Emission Tomography - Computed Tomography (PET- CT) will be performed before and after gefitinib to assess the response. Circulating tumour cells (CTCs) and plasma Deoxyribonucleic acid (DNA) will be acquired at baseline, 2 weeks and 4 weeks after gefitinib treatment. Resected tumor will be sectored in details to study the spatial heterogeneity.

Eligibility Criteria:
Inclusion Criteria:

* EGFR mutation positive Non-Small Cell lung cancer (NSCLC) (regardless of smoking status), or control group may encompass other molecular subtypes of lung cancer e.g. anaplastic lymphoma kinase (ALK) and Kirsten rat sarcoma viral oncogene homolog (KRAS).
* All early stage patients with NSCLC who are deemed surgically resectable.
* All patients must have histologically proven NSCLC, with known EGFR mutation
* Patients should be fit for either lobectomy/ pneumonectomy with or without lymph node sampling.
* Primary tumour should be at least 2 cm in size (Tumor stage 1b).
* Willing to provide informed consent.

Exclusion Criteria:

* Known severe hypersensitivity to gefitinib or any of the excipients of this product
* Any serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
* Interstitial lung disease (ILD) or pulmonary fibrosis; impaired pulmonary function (e.g. FEV1 \<40% predicted value, artery blood gas PaO2\<60mmHg)
* Patients with prior exposure to agents directed at the Human epidermal receptor (HER) axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
* Patients with prior exposure to chemotherapy, irradiation or systemic anti-cancer therapy (e.g. monoclonal antibody therapy) for lung cancer.
* Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within six months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
* Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the subject at high risk for treatment-related complications.
* Patient who has serious active infection.
* Patients who harbouring exon 20 T(Threonine)790M (Methionine) mutation.
* Pregnancy or breast feeding.
Immediate Effect of Mobilization with Movement on Squat Self-reported Functional Ability, Pain Intensity, and Pain-free Range of Motion in People with Knee Osteoarthritis

Mobilization with movement (MWM) appears to reduce pain, improve knee range of motion, and enhance physical functioning in individuals with knee osteoarthritis (KOA). However, it remains unclear whether the severity grading of structural damage in KOA affects its effects. This study aims to analyze the immediate effect of MWM on squat self-reported functional ability, pain intensity, and pain-free range of motion in people with KOA, and to verify it its effect is influenced by the severity grading of structural damage.


Eligibility Criteria:
Inclusion Criteria:

* male or female;
* aged over 45 years;
* clinically diagnosed with symptomatic unilateral KOA, classified as grade 1-3 according to the Kellgren and Lawrence system;
* fulfilled the classification criteria of the American College of Rheumatology for KOA;
* reported frequent episodes of pain in the knee joint during sit-to-stand movements for at least 3 months.

Exclusion Criteria:

* had KOA secondary to rheumatoid arthritis and other inflammatory and autoimmune conditions;
* reported lumbar pain radiating to the knee or lumbar pain as the primary complaint;
* had a history of knee or lower limb surgery;
* had a systemic or local infection;
* had received an intra-articular corticosteroid or hyaluronic acid injection within the past 6 months;
* reported current or past (within 4 weeks) oral corticosteroid use;
* had any condition in the lower limbs that would prevent performing the deep squat test;
* had clinical conditions in which manual therapy is generally contraindicated (such as fracture, osteoporosis, instability, infectious arthritis, tumors, joint ankylosis, acute inflammatory disorders, or lack of a diagnosed joint lesion).
A Real-World Study on Extranodal Lymphoma

The aim of this study is to prospectively collect clinical information on patients with extranodal lymphoma, and to explore the best therapeutic strategies in the real-world population.

Lymphoma is a common hematological malignancy. Many different pathologic types of lymphoma can originate in extranodal organs or be associated with extranodal organ involvement. For lymphoma with extranodal involvement, conventional regimens often cannot provide satisfactory results for patients. This study aims to prospectively collect clinical information on patients with extranodal DLBCL, including the distribution of involved sites, clinical and molecular characteristics of different lymphoma subtypes, clinical treatment protocols, and prognosis, to explore the the best therapeutic strategies in the real-world population.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years (including 18 years old).
2. Patients newly diagnosed with non-Hodgkin lymphoma with extranodal involvement, whether it is primary, secondary, or cannot be determined.
3. Patients who have received systematic clinical treatment.
4. Patients with measurable lesions, at least containing one effective evaluation of efficacy.

Exclusion Criteria:

1. Patients who only receive supportive treatment.
2. Patients who cannot obtain effective evaluation data of efficacy.
Platelet Rich Fibrin+1% Alendronate in Treatment of Mandibular Degree II Furcation Defects

The present study was designed to evaluate the combined efficacy of PRF and 1% ALN in the treatment of mandibular degree II furcation defects when compared with PRF and open flap debridement (OFD) alone.

Background: Various regenerative materials have been introduced and tested in the treatment of furcation defects. Platelet-rich fibrin (PRF) is a reservoir of growth factors and cytokines which are the key factors for regeneration of bone and maturation of the soft tissue. Alendronate (ALN), a potent member of bisphosphonate group is known to promote tissue regeneration by inhibiting osteoclastic bone resorption and promoting osteoblastogenesis. The present study was designed to evaluate the combined efficacy of PRF and 1% ALN in the treatment of mandibular degree II furcation defects when compared with PRF and open flap debridement (OFD) alone.

Methods: Seventy two mandibular furcation defects were treated with either OFD alone (Group 1), OFD with PRF (Group 2), and OFD with PRF+1% ALN (Group 3). Clinical parameters; site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), relative vertical attachment level (RVAL) and relative horizontal attachment level (RHAL), intrabony defect depth (IBD) were recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic defect fill was evaluated at baseline and 9 months.

Eligibility Criteria:
Inclusion Criteria:

* Presence of buccal Class II furcation defects in endodontically vital, asymptomatic mandibular first and second molars with a radiolucency in the furcation area on an intraoral periapical radiograph with probing depth (PD) ≥ 5mm and horizontal ≥ PD 3mm after phase I therapy i.e, scaling and root planing (SRP);
* No history of antibiotic or periodontal therapy in the preceding 6 months.

Exclusion Criteria:

* Systemic conditions known to affect the periodontal status;
* Medications known to affect the outcomes of periodontal therapy;
* Hematological disorders and insufficient platelet count (\<200,000/mm3);
* Pregnancy/lactation;
* Smoking and tobacco use in any form
* Immunocompromised individuals;
* Those having unacceptable oral hygiene (plaque index \[PI\] \>1.5).
* Teeth with furcation involvement, non-vital teeth, and carious teeth indicated for restorations and mobility of at least grade II
* Aggressive periodontitis
Time Restricted Feeding on Nonalcoholic Fatty Liver Disease ( TREATY-FLD )：a 12-month Follow-up Study

Time restricted feeding (TRF) is a novel type of intermittent calorie restriction diet that involves eating a daily period of 8 hours or less. This is a 6-month follow-up study of TREATY-FLD trial to evaluate the effect of time restricted feeding (TRF) on hepatic fat contents and cardiometabolic risk factors in obese adults over 6 months compared to continuous energy restriction (CER).


Eligibility Criteria:
Inclusion Criteria:

1. Man or women aged≥18 years;
2. Subjects with NAFLD determined by MRI (intrahepatic triglyceride content ≥5%);
3. Body mass index (BMI)of 28.0 to 45.0 kg/m2;

Exclusion Criteria:

1. History of alcoholic liver disease, chronic viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, cirrhosis, and liver cancer;
2. History of HIV, or active pulmonary tuberculosis;
3. Diagnosis of type 1 and type 2 diabetes;
4. History of malignant tumors;
5. Serious liver dysfunction or chronic kidney disease (AST or ALT \> 3 times the upper limit of normal, or eGFR\<30 ml/min/1.73 m2);
6. Significant alcohol consumption in the past six months (Consumed more than 20 g/day for women or 30 g/day for men);
7. History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
8. History of severe gastrointestinal diseases or gastrointestinal surgery in the past 12 months;
9. History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;
10. Being a smoker or having been a smoker in the 3 months prior to their screening visit;
11. Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
12. Currently participating in weight loss programs or weight change in the past 3 months (\> 5% current body weight) ;
13. Women who are pregnant or plan to become pregnant;
14. Patients who cannot be followed for 24 months (due to a health situation or migration);
15. Patients who are unwilling or unable to give informed consent.