cyrilzakka/clinical-trials huggingface dataset:
Natural History of Isolated Calf Vein Thrombosis - A Prospective Cohort Under Ultrasound Surveillance

The treatment of ICVT is still controversial as conflicting international guideline strategies show. Evidence suggests that propagation rates of ICVT without risk factors are low. Unless ICVT propagates to proximal veins anticoagulation can safely been withheld, thereby avoiding a bleeding risk for the patient. However, the impact of different risk factors on propagation rates is not well understood. This gap in knowledge can only be filled by a natural history study of ICVT without anticoagulation. Since patients are safe as long as no propagation occurs close ultrasound surveillance is an adequate safety umbrella for the natural history study period. In addition, it provides an objective outcome measure to define the impact of risk factors.

For the purpose of this study, ICVT is defined as any thrombus being present in the calf muscle veins and/or in the deep paired calf veins as long as they do not affect the confluence (trifurcation) area or the popliteal vein.

Patients presenting with symptomatic ICVT will be examined by CCUS for both legs (V1). Inclusion/exclusion criteria will be checked, and patients will be informed about the nature of the study. In case patients provide informed consent, no anticoagulation therapy is given. Compression stockings at the calf length will be prescribed for 30 days.

CCUS will be repeated on day 5±2 (V2), day 10±2 (V3), and day 30±4 (V4). If the ICVT has propagated into the trifurcation area, the popliteal vein, or into more proximal veins therapy will be implemented according to current guidelines for proximal DVT. If no propagation to proximal veins has occurred anticoagulation will be withheld further on

Eligibility Criteria:
Inclusion Criteria:

* Presence of symptomatic ICVT proven by CCUS
* Absence of proximal DVT or PE
* Age of 18 or older
* Outpatient and inpatient status
* Written informed consent

Exclusion Criteria:

* Bedridden patients
* Prior unprovoked VTE
* Active malignancy (diagnosis within the last 6 months, and/or incomplete resection, and/or ongoing radiotherapy or chemotherapy, and/or metastatic disease).
* Pregnancy
* Therapeutic anticoagulation therapy for reasons other than VTE
PD-1 Antibody Expressing CAR-T Cells for EGFR Family Member Positive Advanced Solid Tumor (Lung, Liver and Stomach)

Objectives:

To evaluate the safety and effectiveness of cell therapy using herinCAR-PD1 cells to treat relapsed or refractory cancer.

Eligibility:

Individuals greater than or equal to 18 years of age and less than or equal to 70 years of age who have been diagnosed with relapsed or refractory cancer that has not responded to or has relapsed after standard treatment.

A total of 20 patients may be enrolled over a period of 1-2 years.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18\~65 years old, male or female;
2. Life expectancy≥6 months;
3. ECOG score: 0-3;
4. Advanced solid tumor (lung cancer, gastric cancer, liver cancer) were diagnosed by pathological or clinical physicians;
5. Enough venous channel, no other contraindications to the separation and collection of white blood cells;
6. Immunohistochemistry and RT-PCR technology will be used to determine the positive EGFR family (including EGFR, HER2, HER4) and IGFR1 protein. At least one protein expressed in immunohistochemical tumor tissue should be no less than grade 2 or 2+ scores. The levels of protein are defined as follows: (according to cell staining) : grade 0: without staining; grade 1: 1-25%; grade 2: 26-50% and grade 3: 51-100%; (According to the intensity): negative; 1+; 2+ and 3+;
7. Laboratory examination: white blood cell≥3 x 10\*9/L, blood platelet count≥60 x 10\*/L, hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level；
8. Signed informed consent；
9. Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion.

Exclusion Criteria:

1. Expected Overall survival \< 6 months;
2. Patients with uncontrolled hypertension, unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> Class II, NYHA), or myocardial infarction within 6 months.
3. Abnormal lung function: FEV (forced expiratory volume) \< 30% prediction, DLCO (diffusing capacity of the lung for carbon monoxide) \< 30% prediction, blood oxygen saturation \< 90%;
4. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
5. Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
Hematopoietic Stem Cell Transplantation for Malignant Infantile Osteopetrosis

The purpose of this study is to evaluate the efficacy and side effects of donor hematopoietic cells using chemotherapy regimen without total-body irradiation in children undergoing a hematopoietic stem cell transplant for Malignant infantile osteopetrosis. The blood stem cells will be derived from either related donor or unrelated umbilical cord blood or haploidentical donor.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Osteopetrosis confirm by bone biopsy and radiographic imaging
* Age up to 5 year old

Exclusion Criteria:

* Carbonic Anhydrase II (CAII) deficiency osteopetrosis variant
* Creatinine clearance ≤ 40ml/min/1.73m\^2 or RTA
* Bilirubin ≥ 3mg/dL
* SGPT ≥ 500 U/L
* Current severe infection
* Evidence of CNS involvement
* Morbidity such as blindness or deafness
Biopsy After Radioembolization to Identify Changes in Tumor Cells From the Radiation

The purpose of this study is to study the way radioembolization works by collecting biopsy samples of participants' tumors after the procedure. This research may improve the way that radioembolization is performed, which could help people whose cancer has spread to the liver. The research may also provide information about how tumors respond to radioembolization.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* histologically confirmed primary adenocarcinoma of the colon or rectum
* CLM considered unresectable or not amenable to percutaneous ablation
* existent tissue samples from a standard of care biopsy of the target tumor within 42 days prior to treatment OR clinical indication for biopsy at the time of the treatment under the institutional guidelines for progression of disease.
* adequate blood cell counts (WBC \> 1.5 x 109/L, platelet count \> 50 x 109/L)
* adequate renal function (creatinine \< 1.5 mg/dL)
* total bilirubin level ≤ 1.5 mg/dL

Additional inclusion criteria for patients, undergoing 90Y radiation segmentectomy:

A. patients not amenable to surgery or thermal ablation

Exclusion Criteria:

Study exclusion criteria will be similar to general TARE exclusion criteria, which are as follows:

* prior hepatic radiotherapy (The lesion / lobe being treated cannot have had prior treatment with radiotherapy - untreated lesions / lobes in the liver may be evaluated under the protocol)
* severe cirrhosis
* severe portal hypertension
* uncorrectable flow to the gastrointestinal tract and/or \>30 Gy (or \>50 Gy in multiple sessions) radiation absorbed dose to the lungs

All patients with liver-dominant disease will be considered candidates for TARE even in the face of oligometastatic (up to 5 sites) extrahepatic disease, that is stable or controlled by chemotherapy.
Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab Administered Intravenously in Adult Participants at High Risk of Delayed Graft Function After Kidney Transplantation

The primary objective of this study is to demonstrate the efficacy of ravulizumab vs placebo in reducing the severity of DGF as measured by time to freedom from dialysis in adult participants who are at high risk of DGF after undergoing transplant of deceased donor kidney.

AWAKE is a multicenter, prospective study to evaluate the safety and efficacy of ravulizumab in reducing delayed graft function (DGF) in kidney transplant recipients at high risk for DGF. Eligible participants will be randomized in a 1:1 ratio to receive either ravulizumab or placebo intravenously.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age at the time of signing the informed consent
* Diagnosed with Dialysis-dependent End-Stage Kidney Disease (ESKD)
* A candidate for kidney transplant from:

  1. Donation after Circulatory Death (DCD) donor
  2. High-risk Donation after Brain Death (DBD) donor

Exclusion Criteria:

* Is to receive a kidney from a donor with category I,II,IV and V Maastricht Classification
* Diagnosed with Acute Kidney Injury (AKI) of Stage 3 severity according to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines.
Evolution of Pulmonary Ultrasound in Patients Hospitalized for Covid (Coronavirus Disease) 19

Clinical thoracic ultrasound plays an important role in the exploration, diagnosis and follow-up of thoracic pathologies.

The COVID (Coronavirus Disease) epidemic is leading to a large influx of patients in the emergency department with respiratory disorders. The rapid diagnosis of respiratory disorders in infected patients is important for further management.

Chest ultrasound has already demonstrated its value in the diagnosis of pneumonia in the emergency department with superiority over chest X-ray.

However, there is little data on the thoracic ultrasound semiology of viral pneumonia in general and of COVID in particular.

Chest ultrasound has already shown its value in the diagnosis of pneumonia in the emergency department with superiority over chest X-ray.

However, there is little data on the thoracic ultrasound semiology of viral pneumonia in general and of COVID in particular.

Peng reported data from 20 patients and compared them to chest CT. The abnormalities are a thickening of the pleuropneumonia line, an interstitial syndrome with B lines, corresponding to frosted glass opacities, confluent B lines (snowstorm appearance) corresponding to interstitial infiltrate, sub-pleural alveolar opacities corresponding to sub-pleural condensations, more frank alveolar images corresponding to alveolar opacities. A multifocal aspect was associated with involvement of more than 2 lobes. However, the frequency of these abnormalities as well as the sensitivity of the echo are not detailed in this article.

Another Italian article describes a clinical case of COVID-19 pneumonia with sub-pleural involvement and irregularity of the pleuro-pulmonary line.

Clinical thoracic ultrasound has a major potential interest during the COVID epidemic: available at the patient's bedside, avoiding the need to move around, feasible for the physician during his visit, easy to clean especially if ultraportable devices are used, fast and not exposing the staff any more than the usual clinical examination.

In order to determine whether this technique is useful in the management of infected patients or patients suspected of COVID-19 infection with respiratory signs, we propose a descriptive prospective study evaluating the ultrasound semiology of COVID-19 pneumonia and the interest of ultrasound in the evolutionary follow-up of these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to hospital with proven COVID-19 infection with respiratory signs warranting a chest CT scan

Exclusion Criteria:

* Patient not agreeing to have his or her data collected for the study
* Unconscious patient
Introduction of an Operating Room Black Box to Identify, Analyse and Prevent Errors in the Vascular Hybrid Room

The "OR Black box", an inclusive multiport data capturing system has been developed and successfully used for detailed analysis of laparoscopic surgical procedures. A pilot study has shown that this system can be successfully installed in the hybrid room at Ghent University Hospital and used for detailed analysis of intra-operative errors and radiation safety issues in endovascular procedures.

Secondary analysis of pilot study data via direct video coding assessed the relationship between leadership style of the surgeon and team behavior and possible fluctuations during surgery.

This novel approach allows a prospective objective assessment of human and environmental factors as well as measurement of errors, events and outcomes. In this study, the aim is to use the acquired knowledge to characterize a chain of events, identify high-risk interventions and identify areas for improvement, both on an organizational, team or individual level.

Hypothesis: non-technical skills, environmental factors and teamwork in the hybrid room correlate with surgical technical performance and error rates. Furthermore, we hypothesize that incidents and adverse events can be tracked to a chain of errors that is influenced by technical and non-technical skills as well as environmental factors.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective (planned more than 48 hours) endovascular procedures.
* Symptomatic aortic-iliac-femoral-popliteal-below the knee atherosclerotic stenotic or occlusive disease (PVI)
* Endovascular exclusion of thoracic aortic, infrarenal abdominal aortic and/or iliac aneurysm repair (EVAR)

Exclusion Criteria:

* No consent of patient
* No consent of all endovascular team members
* Emergency procedure (planned \< 48h before)
* Endovascular procedure not treating atherosclerotic aortic-iliac-femoral-popliteal-below the knee disease or aortic-iliac aneurysm
Seroprevalence of Hepatitis B and Immune Response to Hepatitis B Vaccination in Chinese College Students

At present, children less than 15 y of age have been regarded as a key group for hepatitis B immunization in China. However, there is not yet special immunization strategy for population above 15 y of age. In this study, we investigated the seroprevalence of hepatitis B and immune response to HB vaccine among Chinese college students to uncover the need on universal mass vaccination or booster immunization only for students with HBV vaccination history against hepatitis B in Chinese college students to inform decision making.


Eligibility Criteria:
Inclusion Criteria:

* Male and female freshmen in one college in Liuzhou city of Guangxi Zhuang Autonomous Region

Exclusion Criteria for vaccination study:

* acute illness
* immunocompromised conditions
* renal insufficiency
* pregnancy
* allergic history to HB vaccine or yeast
* positive for any of HBsAg, anti-HBs or anti-HBc
A Cross-sectional Study on the Prevalence and Extraesophageal Symptoms of Gastroesophageal Reflux Disease(GERD) in Patients With Upper GI Symptoms, Visiting the Outpatient Departments of Peripheral Hospitals in Greece

The present study has been designed to provide current data on GERD prevalence in several regional areas of Greece outside the two major urban centres (Athens and Thessaloniki), to measure the treatment response in GERD patients, and to assess the correlations between the two methods of diagnosing GERD, i.e. reporting of symptoms by the patient to the physician and completion of the GerdQ questionnaire by the patient. Additionally, this study aims to provide data on the prevalence of extraesophageal symptoms in GERD patients in Greece. The XQS questionnaire will be applied for the identification of these patients and the assessment of the extraesophageal disease burden (frequency and intensity/severity). Finally, an association between the GerdQ and XQS scores will be attempted.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Patients aged 18 and over
* Patients with upper-GI symptoms during the last week prior to the study visit

Exclusion Criteria:

* History of oesophageal, gastric or duodenal surgery
* Patients with history of malignancy
* Treatment with acetylsalicylic acid/NSAID during the last week prior to the study visit
* Therapy with PPI for the healing of ulcer induced by treatment with acetylsalicylic acid/NSAID
* Therapy with PPI for HP eradication or for healing of HP-related peptic ulcer
Observational Study of the Wellinks Solution Impact on Quality of Life and Clinical Outcomes in Patients With COPD

The clinical objectives of this study are to determine whether utilization of the Wellinks COPD Solution can improve quality of life for patients with COPD, can reduce healthcare resource utilization over time, and can improve pulmonary function as measured by connected devices.

The nonclinical objectives of this study are to describe the experience of patients using the Wellinks Solution through the assessment of patient engagement with the solution, as well as by patient-reported satisfaction with the solution and their perceived value (e.g., willingness to pay). Qualitative feedback on the features and functionality of the Wellinks Solution will be solicited.


Eligibility Criteria:
Inclusion Criteria:

* COPD diagnosis (confirmed by the patient and assumed based on participation in COPD PPRN)
* Home telephone (landline or mobile) and internet access
* Smartphone: iPhone 6S or later model, running iOS 14.0 or later; Android 6 or later model
* Proficient in English language
* Living/staying in the United States throughout the study duration
* Willing and able to comply with study requirements
* Able to provide written informed consent

Exclusion Criteria:

* Current participation in other interventional clinical trials
* Current participation in a pulmonary rehabilitation program
A Study in Healthy Subjects to Investigate Whether Administration of Lucerastat Can Affect Normal Heart Function

Two-part Phase 1 study to assess the effect of single therapeutic and supra-therapeutic doses of lucerastat on the QT/QTc interval duration in healthy subjects (Part A: Pilot study; Part B: TQT study)


Eligibility Criteria:
Inclusion Criteria:

Part A only:

- Healthy male subjects aged between 18 and 55 years.

Part B only:

* Healthy male and female subjects aged between 18 and 55 years.
* Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 pre-dose of the first period. They must consistently and correctly use a highly effective method of contraception, or be sexually inactive, or have a vasectomized partner.
* Women of nonchildbearing potential (i.e., postmenopausal, XY genotype, Turner syndrome, uterine agenesis).

Part A and B:

* Signed informed consent prior to any study-mandated procedure.
* Body mass index of 18.0 to 30.0 kg/m2 (inclusive) at Screening. Body weight at least 50.0 kg at Screening and prior to first study treatment administration.
* Healthy on the basis of medical history, physical examination, cardiovascular assessments and clinical laboratory tests.

Exclusion Criteria:

Part B only:

* Known hypersensitivity to moxifloxacin or any of its excipients.
* Pregnant or lactating women.
* Women planning to become pregnant.

Part A and B:

* Previous exposure to lucerastat.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
* History or presence of rhythm disorders.
Taxane Combined Targeted Therapy for Low-risk HER2 Positive and Lymph Node Negative Breast Cancer

Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and high risk of recurrence and metastasis. HER2 targeted drugs has greatly improved the prognosis and survival of such patients. At present, for HER2 positive breast cancer patients with negative lymph nodes, chemotherapy drugs combined with trastuzumab is the current standard treatment scheme, and in most cases, chemotherapy uses a combination of two drugs, while the main beneficiaries of the trastuzumab and paltuzumab are concentrated in the group of patients with positive lymph nodes. Can targeted therapy be used to reduce the progression of chemotherapy and further achieve efficient and low toxicity strategies. To explore the efficacy and safety of adjuvant therapy of taxane chemotherapy combined with trastuzumab targeting therapy for low-risk HER2 positive and lymph node negative early breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* 1) Treatment in Peking University People's Hospital for radical resection of breast cancer and had hospitalization records;
* 2) Postoperative pathology confirmed invasive breast cancer, and the pathological stage was T1a-b (T ≤ 1cm), N0, HER2 positive, with high-risk factors (G3, or hormone receptor negative); Or the pathological stage is T1c (1cm \< T ≤ 2cm), N0, and there are no high-risk factors (G1/G2, hormone receptor positive);
* 3)Signed an agreement to participate in the PKUPH Breast Disease Cohort study at Peking University People's Hospital.

Exclusion Criteria:

* 1) Lack of clinical pathological data (such as imaging data, pathological data);
* 2) Preoperative neoadjuvant therapy;
* 3) Patients with metastatic breast cancer or bilateral breast cancer;
* 4) Failed to undergo curative surgery.
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 HCV and HIV-1 Co-infection

Target Population: Hepatitis C Treatment Naïve, non-cirrhotic, Chronic genotype 1 hepatitis C virus (HCV) infected adults that are co-infected with human immunodeficiency virus (HIV)-1and have HCV RNA \< 6 x106 IU/mL

Duration of Subjects will be treated for 8 weeks and followed for 24 weeks post- Treatment: treatment


Eligibility Criteria:
Inclusion Criteria:

* Chronic HCV GT1, treatment-naïve, non-cirrhotic adult subjects.
* HCV RNA levels more than 10,000 IU/mL and less than 6,000,000 IU/mL at Screening

Exclusion Criteria:

* Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug.
* Solid organ transplantation.
* Significant cardiac disease or other significant co-morbidities that could interfere with study treatment.
* Malignancy within the 3 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc.). Subjects under evaluation for possible malignancy are not eligible.
* Infection with hepatitis B virus (HBV)
Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD1446 to Healthy Volunteers

The primary purpose of this study is to assess the safety and tolerability of AZD1446 following single dose administration.


Eligibility Criteria:
Inclusion Criteria:

* physical healthy volunteers
* weight between 50 to 100 kg and a body mass index (BMI) between 19 and 30 kg/m2

Exclusion Criteria:

* History of any clinically significant disease or disorder.
* History of severe allergy/hypersensitivity reactions
COLPAC (RaDiCo Cohort) (RaDiCo-COLPAC)

The goal of this observational study is to describe the various clinical, biological and radiological manifestations of LPAC syndrome, defined according to standard diagnostic criteria, or according to criteria extended to all symptomatic recurrent biliary lithiasis, and delineate the various possible evolutions.

Participants will be followed for 5 years and the inclusion sites will collect the necessary data at least once a year as part of routine patient care. A quality of life self-questionnaire will be completed by participants during these visits.


Eligibility Criteria:
Inclusion Criteria:

* Children or adults meeting the standard\* or extended\*\* diagnostic criteria for LPAC syndrome:

  1. First symptoms before the age of 40 years
  2. Radiological images compatible with the existence of intrahepatic lithiasis
  3. Recurrence of symptoms after cholecystectomy

     (\*) standard criteria: symptomatic biliary lithiasis with at least 2 out of 3 criteria

     (\*\*) extended criteria: symptomatic biliary lithiasis with 1 out of 3 criteria

     Exclusion Criteria:
* Patients who have undergone liver transplantation