cyrilzakka/clinical-trials huggingface dataset:
The Use of iNPWT for Management of ALT Flap Donor Site Wound

Primary closure or skin grafting of the donor site after harvest of a anterolateral thigh flap (ALT) is associated with significant morbidity. Incisional negative pressure wound therapy (NPWT) may decrease complications in high-risk incisions. Successful use of NPWT has been reported in the treatment of ALT flap donor site wounds in a retrospective observational study, but no prospective study of NPWT application in the ALT flap donor site has been reported. This study aims to assess the incidence of complications at ALT flap donor site with an incisional NPWT device, PREVENA™. A prospective, controlled, pair-matched study has been designed to compare the effectiveness, complication rate, and scar quality of ALT flap donor site between using incisional NPWT and conventional bolster dressing.

Primary closure or skin grafting of the donor site after harvest of a anterolateral thigh flap (ALT) is associated with significant morbidity. Incisional negative pressure wound therapy (NPWT) may decrease complications in high-risk incisions. Successful use of NPWT has been reported in the treatment of ALT flap donor site wounds in a retrospective observational study, but no prospective study of NPWT application in the ALT flap donor site has been reported. This study aims to assessed the incidence of complications at ALT flap donor site with an incisional NPWT device, PREVENA™. A prospective, controlled, pair-matched study has been designed to compare the effectiveness, complication rate, and scar quality of ALT flap donor site between using incisional NPWT and conventional bolster dressing.

Eligibility Criteria:
The study is designed as a prospective randomized clinical trial. This study aims to enroll patients who require a free ALT flap for head and neck reconstruction. Inclusion criteria are as follows:

1. The donor site of ALT flap can be closed primarily.
2. Age≥20 years and \<80 years
3. ALT flap size measuring more than 6 cm in width
4. Patients will be required to understand and be willing to participate in the trial and be able to comply with the follow-up visits

Exclusion criteria are as follows:

1. he donor site of ALT flap can not be closed primarily.
2. Uncontrolled diabetes mellitus, as measured by HbA1c≥10%
3. Under renal replacement therapy for more than 1 year.
4. Pregnant woman
Validity of a Belt Mounted Accelerometer to Assess Walking Measures in Patients With Chronic Stroke

The aim of this study is to validate the G-walk for several gait parameters, tested against a gold standard three dimensional camera system. This research will inform researchers and practitioners as to whether the G-Walk is a suitable and valid tool to easily assess walking ability in people with chronic stroke.

Twenty chronic stroke survivors will be recruited for this study from an independent neuro-physiotherapy practice and community exercise programme.Gait analysis will be used to look at several gait parameters through the use of a three-dimensional visual analysis system based in our Biomechanics Lab at the University of Winchester. Participants will attend testing one testing session of approximately 1 hour. During this testing session functional measures and walking trials will be assessed. Participants will first be asked to complete a set of simple movements that will contribute towards Fugl Meyer questionnaire. Twenty eight reflective markers will then be attached to specified joints and segments of the body, such as the thigh, with double sided sticky tape to allow for data collection through the camera system to collect kinematic data. The belt mounted accelerometer (G-Walk) will be positioned around the waist over the L5 vertebrae. Participants will be asked to perform 6 walking trials of 10m to collect 3D kinematic and accelerometer gait data.

Eligibility Criteria:
Inclusion Criteria:

* \<3 months post stroke
* Lower limb impairment
* Able to stand and step independently
* Functional ambulation classifications (FAC) of 2-5
* Modified Rankin Scale (MRS) of 1-3
* Cognitively aware to undertake the testing session

Exclusion Criteria:

* Unresolved deep vein thrombosis
* unstable cardiovascular conditions
* open wounds
* active drug resistant infection
* recent fractures of involved limb
* peripheral arterial disease
* incontinence
* severe osteoporosis
* non-weight bearing.
A Study of the Efficacy of the Code Stroke in Spain

Code Stroke is a system for the rapid identification, pre-notification and transport of acute ischemic stroke patients. The objective of this study was to define quality indicators and to compare treatment outcomes in hospitals where Code Stroke has been implemented and hospitals without the use of Code Stroke (control patients).

In a first step qualitative technique has been conducted to define treatment quality indicators of acute ischemic stroke patients. In a second step a prospective study is conducted to collect data of 240 inpatients from two groups of hospitals. Two hospitals applying Code Stroke (N= 120) and four hospitals non-applying Code Stroke procedure (N=120). A consecutive sampling method will be conducted. Inclusion criteria: acute ischemic stroke patients treated in the hospitals during the field study. The referral to the hospital could be from primary care, Emergency Unit of other hospital. Patients will enroll after inform consent.

A Singer-blind- research method will applied. Quality indicators defined in the first phase will be applied and comparisons will be realized using ANOVA.

Eligibility Criteria:
Inclusion Criteria:

* acute ischemic stroke in-patients

Exclusion Criteria:

* Patients who refuse participate
Study of JANX008 in Subjects with Advanced or Metastatic Solid Tumor Malignancies

This study is a first-in-human (FIH), Phase 1/1b, open-label, multicenter dose escalation and dose expansion study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of JANX008 in adult subjects with advanced or metastatic carcinoma expressing EGFR.


Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥18 years of age at the time of signing informed consent
* Histologically or cytologically documented locally advanced or metastatic NSCLC, SCCHN, CRC, RCC, SCLC, PDAC, TNBC
* Progressed or was intolerant to all available therapies known to confer clinical benefit appropriate for the tumor type
* Adequate organ function
* At least 1 measurable lesion per RECIST 1.1

Exclusion Criteria:

* Treatment with anti-cancer therapy within 28 days or ≤5 elimination half-lives, whichever is earlier, before enrollment
* Prior treatment with EGFR-targeted bispecific T cell engager or CAR-T cell therapy
* Prior treatment with CD3 engaging bispecific antibodies
* Clinically significant cardiovascular diseases
* Active clinically significant infection (bacterial, viral, fungal, mycobacteria, or other)
* On supplemental oxygen
* Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment
Early Onset Preeclampsia and Nectin-4

Early-onset Preeclampsia (PE) is a pregnancy disorder which may present with adverse pregnancy outcomes. Nectin-4 is an adhesion molecule mainly expressed in placenta. This study aimed to evaluate the relationship between early onset Preeclampsia and serum Nectin 4 levels.

Preeclampsia is assumed as a two-stage disorder arising from defective trophoblast invasion and failure of spiral artery remodeling as the main step responsible for the pathogenesis. PE is classified according to the disease onset time as early-onset PE before 34 weeks and late-onset PE after 34 weeks. Late-onset PE is more commonly seen and accepted as a mild maternal reaction to pregnancy. In early-onset PE, unlike the late-onset, due to the improper placental invasion, the diffuse placental ischemia and the resulting oxidative stress begin at early gestation. Thus, the early-onset PE may result in severe disease leading to perinatal and maternal morbidity and mortality.

The nectins are calcium-independent immunoglobulin-like celladhesion molecules and have a pivotal role at cellular junctions, as well as physiological regulations(8). Placenta expressesfor types of nectins; nectin-1, nectin-2, nectin-3, and nectin-4. They are localized at tight junctions and gap junctions of syncitiotrophoblasts(9). Nectin-4 is a relatively novel member of nectin family which has been detected only in placenta and airway epithelium in healthy subjects.

Despite, there has been no study published yet to reveal the soluble nectin-4 levels in preeclampsia as well as in early onset disease. In this study, we aimed to investigate the serum nectin-4 levels in early-onset preeclampsia in comparison of the healthy pregnancies.

Eligibility Criteria:
Inclusion Criteria:

* spontaneous,
* singleton pregnancies
* above the 24 weeks of gestations
* positive fetal cardiac activity

Exclusion Criteria:

* multiple gestations,
* chronic hypertension
* hypothyroidism
* known malignancy,- diabetes mellitus,
* presence of fetal or maternal infection,
* clinical signs of chorioamnionitis (maternal fever, vaginal discharge, fetal tachycardia),
* hepatic or renal failure
* Placenta previa or pregnancies accompanied congenital fetal abnormalities or aneuploidies
Second Forward View Examination of Proximal Colon on Adenoma Detection Rate

This clinical trial is being conducted to assess whether second forward view examination of proximal colon could increase adenoma detection rate of right colon.


Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing colonoscopy for screening in our hospital

Exclusion Criteria:

* previous history of resection of colon;
* familial polyposis syndrome
* inflammatory bowel disease
* active antiplatelet or anticoagulant therapy prevent polypectomy;
* pregnancy or lactating women
Replication Study to Analyze the Surgical Treatment of Proximal Humeral Fracture

The study at hand aimed to analyze the replicability of the observed treatment effects in these studies published by Koeppe et al. and Stolberg-Stolberg et al.

see Protocol

Eligibility Criteria:
Inclusion Criteria:

- all patients will be included, who had an inpatient coded treatment using LPF or RTSA

Exclusion Criteria:

* Incomplete insurance status within two years before index
* Incomplete basic information
* Age\<65 years
* Missing diagnosis of PHF (ICD: S42.2) within two years before surgery
* Previous surgical treatment (RTSA, LPF or other fracture fixation)
* Coded polytrauma
* Bone tumors/ bone metastasis
* Both sides or missing information of surgery side
* COVID-19 infection during index hospitalization
CPG 7909 Plus Herceptin® In Patients With Metastatic Breast Cancer

To determine the safety and efficacy of CPG 7909 Injection given with Herceptin to patients with metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed breast cancer with metastases
* Tumor that has overexpression of HER2 as documented by being either FISH-positive or HER2/neu 3+ confirmed by immunohistochemistry
* Patients may have had up to three prior chemotherapy regimens for metastatic disease, which may have been given in combination with Herceptin® and which may have been discontinued due to toxicities. In addition, patients may have had adjuvant chemotherapy.
* Phase II only: Must have measurable disease by RECIST criteria (defined in section 8) with at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques, or as \> 10 mm with spiral CT scan

Exclusion Criteria:

* Any prior therapy with anthracycline + Herceptin® concurrently
* Significant cardiovascular disease (e.g., NYHA class 3 congestive heart failure, myocardial infarction within the past 6 months, unstable angina; coronary angioplasty within the past 6 months, uncontrolled atrial or ventricular cardiac arrhythmias) or left ventricular ejection fraction \< 50%
* Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia
Effects of Incentive Spirometry on Dyspnea and Chest Clearance in Asthmatic Patients During Seasonal Smog

EFFECTS OF INCENTIVE SPIROMETRY ON DYSPNEA AND CHEST CLEARANCE IN ASTHMATIC PATIENTS DURING SEASONAL SMOG

Asthma is a serious and life threatening chronic respiratory disease that affects the quality of life of more than 23 million Americans- with exposure to air pollution. Air pollution can make asthma symptoms worse and trigger asthma attacks. Particle pollution can cause breathing problems. It's created when tiny bits of dust, dirt, smoke, soot, and other stuff hang in the air. The smaller the particles, the deeper they can get into the lungs and cause breath problems. Seasonal smog aggravates asthma, irritates the lungs, and makes it difficult to breathe. Long-term inflammation from breathing in too much ground-level ozone can permanently scar lung tissue. Smog with high levels of ozone is also particularly damaging for people with asthma. During seasonal smog asthma patients are more affected than normal people. Various consecutive treatments are used to treat the asthma patients for the improvement of quality of life. But at this check the effects of incentive spirometry on dyspnea and chest clearance in asthmatic patients.

This study will be randomized controlled trial. This study will be conducted in Ittefaq Hospital Lahore. Subjects meeting the predetermined inclusion and exclusion criteria. Sample size will be 44 including both male and female. QUESTIONNAIRE used as subjective measurements and ASHMA CONTROL TEST as objective measurement. Dyspnea-12 will be used to check the dyspnea severity in asthma patients and asthma control test will be used to check asthma severity during seasonal smog. Cough and sputum assessment questionnaire will be used to check effectiveness of chest clearance. Subjects of one group will be treated with active cycle of breathing and incentive spirometry and the other group will be treated with only spirometry. Each group will receive 12 treatment sessions with one treatment session per week and it will take less than 1 hour. Pre- treatment reading of dynpnea-12, cough and sputum assessment questionnaire and asthma control test will be recorded. And post-treatment readings will also be recorded.

Outcome variables will be dyspnea-12, incentive spirometry, cough and sputum assessment questionnaire and asthma control test. Most commonly used incentive spirometry to clear the dyspnea and chest clearance in asthma patients. Data will be analyzed on SPSS-25.

Eligibility Criteria:
Inclusion Criteria:

* Age group:30-45
* Patients of bronchial Asthma
* Patients who have difficulty in breathing

Exclusion Criteria:

* Age:\<30 yrs-\>45 yrs
* Patients of COPD,Bronchiectasis,Pneumonia,Pulmonary TB or any other chronic lung disease.
* Patients of HTN, IHD, patients of fever or any other chronic disease
Controlled Attenuation Parameter (CAP) in Liver Allografts

The primary aim is to determine the accuracy of CAP in the quantification of liver steatosis using liver biopsies as reference. Secondarily, investigators will correlate transient elastography (TE) and CAP results, analyze possible associations between CAP/TE and post-liver transplant (LT) clinical outcomes, and evaluate the change in CAP after LT. The study aims to include as many donors as needed to achieve at least 120 transplanted liver allografts.

This is a coordinated study utilizing 3 recruitment centers (University of Arkansas for Medical Sciences \[UAMS\], Stanford University, and Mayo Clinic) 2 liver pathology reading centers (University of Michigan and Mayo Clinic), and 1 coordinating center (University of Arkansas). The cohort study with a cross-sectional component for the primary aim has been completed (through independent Institutional Review Board \[IRB\] agreements) at UAMS, Stanford University, and the Mayo Clinic. The samples collected at the three recruitment centers will be sent to the biopsy center at the University of Michigan and Mayo Clinic for evaluation. The Liver Transplant Program at each of the 3 recruiting centers will identify study subjects during the process of liver allocation to their listed recipients. Criteria for recruitment are as follows:

Inclusion criteria - Liver Recipient

* Men and women, Age 18-years old to 80-years old inclusive Inclusion criteria - Liver Donor
* Valid TE with Fibroscan 530, defined as:

  * At least 10 valid measurements
  * Interquartile Range (IQR)/Median stiffness value \<30% (only in cases with \>7.1 kPa) Exclusion criteria - Liver Recipient
* Patient did not undergo liver transplantation Exclusion criteria - Liver Donor
* Donation after circulatory death (DCD)
* No liver biopsy obtained during organ procurement process

Eligibility Criteria:
Inclusion criteria - Liver Recipient

* Men and women, Age 18-years old to 80-years old inclusive

Inclusion criteria - Liver Donor

* Valid TE with Fibroscan 402/530, defined as:

  * At least 10 valid measurements
  * IQR/Median stiffness value \<30% (only in cases with \>7.1 kPa)

Exclusion criteria - Liver Recipient

* Patient did not undergo liver transplantation

Exclusion criteria - Liver Donor

* Donation after circulatory death (DCD)
* No liver biopsy obtained during organ procurement process
Best Method of Burn Wound Care: A Prospective Randomized Trial

The purpose of this study is to better understand how to best care for burn wounds.

Participants: Patients presenting to Kamuzu Central Hospital in Lilongwe Malawi with burn wounds occuring within 72 hours of admission.

Procedures (methods): This is a prospective randomized trial. Subjects will be randomized during admission to receive either open dressing care or closed dressing care of their burn wounds.

Eligibility Criteria:
Inclusion Criteria:

* Burn wound admitted to the hospital
* Signed informed consent
* Burn wound occuring within 72 hours of admission

Exclusion Criteria:

* Language other than Chichewa or English
* Inability to access of phone (required for follow-up)
rTMS and Robotic Gait Training in Patients With Stroke

Patients with stroke have demonstrated abnormal muscle tone and postural control ability which affect their ambulation, activity of daily living and confident. Nowadays, utilizing repetitive transcranial magnetic stimulation (rTMS) and robotic machines to assist walking training for stroke patients has been applied to clinic widely. While less studies have compared intervention efficacy for stroke patients between rTMS and robotic training. This study aimed to compare effect of rTMS and robotic training for lower-extremity function and gait in stroke patients.

This study will include subjects occurring stroke within 3 months. All groups will receive traditional rehabilitation. The subjects will be allocated randomly in three groups which are traditional rehabilitation (Group A), robotic training (Group B), and rTMS (Group C) respectively, with 35 people per group. The group B will be intervened 5 times per week and the group C will receive 10 times rTMS intervention during 4 weeks. At post-intervention and eighth weeks after intervention, basic examination will be executed including basic information, history, Mini-mental State examination, Short -Form 36, Modified Ashworth Scale, Fugl-Meyer assessment, static and dynamic motion examination, ultrasound assessment and examination of cardiorespiratory. Two-way mixed ANOVA will be used to analyze the differences of three groups and times.

Eligibility Criteria:
Inclusion Criteria:

* first-time onset of stroke
* reaching 20 years old and having clinical CT and MRI diagnosis of stroke
* hemiparesis with sitting ability after onset 3 months

Exclusion Criteria:

* Brunnstrom stage over grade V
* Combined other neurological diseases (epilepsy, polyneuropathy, Meniere's disease, vestibular neuritis, Parkinson's disease, dementia, spinocerebellar ataxia)
* lower extremity disease, included joint contracture, high muscle tone(MAS more than 3), L/E fracture, Joint replacement, long-term osteoarthritis pain
* unstable vital sign
* can't coordinate or Sign consent plan form
Prevention of Cardiac Dysfunction During Adjuvant Breast Cancer Therapy

Women treated for breast cancer are at increased risk for cardiovascular disease, including heart failure. In this study, by using magnetic resonance imaging (MRI), the investigators want to assess if heart failure medications such as beta blockers and angiotensin receptor blockers can prevent cardiac dysfunction during early breast cancer therapy.

Breast cancer is one of the most common malignancies in women. Recent progress in the detection and treatment of breast cancer has resulted in survival gains, but a consequence of therapeutic advances is an increasing number of long-term survivors who may be at risk for development of cardiovascular disease. Several studies suggest that women treated for breast cancer may be at increased risk for cardiovascular disease, the probable causes being multi-factorial. Importantly, therapies for breast cancer, including radiotherapy, anti-HER-2 regimens and certain chemotherapeutic regimens, may increase the risk of subsequent cardiovascular disease, including atherosclerotic disease, left ventricular dysfunction, and heart failure.

In the current study we propose to undertake a randomized, placebo-controlled, 2x2 factorial, double-blind trial to assess whether left ventricular dysfunction and/or injury is preventable, completely or partly, by the concomitant administration of the angiotensin receptor blocker (ARB), candesartan, and the beta blocker, metoprolol, during postoperative chemotherapy and radiotherapy.

The proposed study addresses an important clinical problem in a large patient group. Thus, the possibility of preventing cardiovascular side effects of contemporary therapy for breast cancer is important both clinically and scientifically.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-70 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Serum creatinine \< 140 μmol/L or estimated creatinine clearance \> 60 ml/min (using the modification of diet and renal disease (MDRD) formula)
* Systolic blood pressure \>= 110 mgHg and \< 170 mmHg
* LVEF \>= 50%

Exclusion Criteria:

* Hypotension, defined as systolic blood pressure \< 110 mmHg
* Bradycardia, defined as heart rate \< 50 b.p.m.
* Prior anthracycline chemotherapy regimen
* Prior malignancy requiring chemotherapy or radiotherapy
* Symptomatic heart failure
* Systolic dysfunction (LVEF \< 50%)
* Clinically significant coronary artery disease, valvular heart disease, significant arrhythmias, or conduction delays.
* Uncontrolled arterial hypertension defined as systolic blood pressure \> 170 mm Hg
* Treatment with ACEI, ARB or beta-blocker within the last 4 weeks prior to study start
* Intolerance to ACEI, ARB or beta-blocker
* Uncontrolled concomitant serious illness
* Pregnancy or breastfeeding
* Active abuse of drugs or alcohol
* Suspected poor compliance
* Inability to tolerate the MRI scanning protocol