cyrilzakka/clinical-trials huggingface dataset:
PERDOVE ANZIANI: a Prospective Cohort Study on Older Patients

This prospective observational cohort study aims at studying functional and clinical outcomes of patients (N = 329) admitted to 4 geriatric hospital facilities of the St John of God Order in Northern Italy during an index period of 4 months. Other areas assessed include variables that help or hinder the discharge of patients with sufficient residential autonomy and the predictive ability of clinicians compared with the evaluation of selective indicators of outcome (clinical and instrumental).

Patients are followed from the first day of hospitalization until discharge or up to 3 months and 1 day after the date of admission ("long-term care" patients).

At admission a "Patient Form" including social, demographic and clinical informations and a series of standardized assessment tools is completed with the help of clinicians, nurses and caregivers (when available).

For each patient, during hospitalization, an analysis of apolipoprotein ApoE polymorphisms is performed and adverse events occurred during hospitalization are monitored, as well as the predictive abilities of clinicians and any recent CT and MRI. Patients are reassessed at discharge (or after 3 months for "long-term care" patients) and at 6 months follow-up of with a standardized telephone interview to assess clinical and functional status and possible changes in the residential status of the patient.


Eligibility Criteria:
Inclusion Criteria:

* age 65 or older
* informed consent provided

Exclusion Criteria:

* younger than 65 years
* informed consent not provided
Long COVID and Its Associations With Health Outcomes in Older Adults

The Peking University Health Cohort in Anning, Yunnan (PKUHC-AN) is a prospective cohort study carried out in Anning, Yunnan. The primary aim of this study is to investigate the impact of COVID-19 on older adults' health, and to provide high-quality evidence of real world research for the optimization of prevention and control strategies of COVID-19 and other emerging infectious diseases. Data will be collected regarding health status, history of COVID-19 infections and vaccines, lifestyle and socioeconomic characteristics, as well as the short- and long-term health outcomes.

COVID-19 pandemic attributed to a great number of mortalities around the world in the last 3 years. About 46% of the global population are estimated to have been infected by the omicron variant and its sublineages. Health outcomes post COVID-19 has been of great concern globally since more and more people infected by SARS-CoV-2. Integrated efforts should be made to estimate the incidence of reinfections and long COVID in China, especially among older adults who are vunlerable and susceptible to COVID-19. In view of this, the Peking University Health Cohort Study in Anning, Yunnan aims to investigate the impact of COVID-19 on older adults' health, and to provide high-quality evidence of real world research for the optimization of prevention and control strategies of COVID-19 and other emerging infectious diseases. Data will be collected regarding health status, history of COVID-19 infections and vaccines, lifestyle and socioeconomic characteristics, as well as the short- and long-term health outcomes.

Eligibility Criteria:
Inclusion Criteria:

* 1. ≥60 years
* 2. Resided in Anning in the past half year and have no plan to move out in next 1 year
* 3. Older adults who are willing to participate in this study with informed consent

Exclusion Criteria:

* 1. Unable to answer questions or communicate
* 2. Older adults who are not willing to participate in this study or without informed consent
Prognostic Value Of Short-Term Follow-up Biomarkers After Discharge In hOspitalized Patients With Acute Heart Failure

Several surrogate biomarkers including natriuretic peptide(NP), and growth differentiation factor-15(GDF-15) and ST2 has prognostic significance in heart failure(HF), and reductions in its value may predict clinical improvement. However, there are limited data regarding the prognostic value of these biomarkers during short-term follow-up after discharge in acute decompensated heart failure. The purpose of this study is to evaluate the prognostic value of short-term follow-up surrogate biomarkers for predicting prognosis of hospitalized patients with acute decompensated heart failure.


Eligibility Criteria:
Inclusion Criteria: the diagnosis of Heart failure requires the following

1. heart failure with reduced ejection fraction ( A 'reduced' ejection fraction (EF) defined as EF \<40%): the presence of symptoms and/or signs of HF
2. heart failure with preserved ejection fraction ( A 'preserved' EF defined as EF≥ 40%) requires the all of the followings: a) the presence of symptoms and/or signs of HF b) elevated levels of natriuretic peptides (defined as B-type natriuretic peptide (BNP) \>100pg/ml and/or N terminal B-type natriuretic peptide (NT-proBNP) \>300pg/ml) c) any structural heart disease (left atrial volume index ≥ 34 mL/m2, left atrial dimension ≥ 50 mm, posterior or septal wall thickness ≥ 11mm)

Exclusion Criteria:

* any severe condition limiting life less than 3 months
* the patient is not ready to contact by telephone at the end of the study
Reproducibility of Ankle Brachial Index After Maximal Exercise

Hemodynamic changes in the lower limbs are very important and rapid after maximal exercise. The automatic method allows a fastest measurement of the Ankle-Brachial Index (ABI). Thus, it appears important to know whether automatic assessment of ABI is as reliable and reproducible as the manual method.

Two methods are mainly used to determine the blood pressure at rest, in a non-invasive way, in order to calculate the Ankle-Brachial Index (ABI). The first method, using a manual sphygmomanometer coupled with a Doppler probe, is considered as the reference method. The second method requires at least one automatic sphygmomanometer. Data from the literature show that these two methods are reproducible to assess ABI at rest. Some authors have reported a better reproducibility of measurements with automatic tool. Others consider that the current accuracy of automatic measurement is insufficient to replace the reference method Doppler. Thus, the aime of the present study is to evaluate whether automatic assessment of ABI is as reliable and reproducible as the manual method.

Eligibility Criteria:
Inclusion Criteria:

* Participant between 18 and 40 years old
* Informed consent signed
* Exclusion Criteria:
* Do not want to participate to the protocol
* Pregnant woman
* Adults to enhanced protection, deprived of their liberty by judicial or administrative authority, without consent hospitalized or admitted to a health facility or social purposes other than research
* Being in a period of exclusion from another biomedical study
* Amputee or with a member dysgenesis
* Not allowed to perform a maximal exercise
Nationwide Treatment Survey of Intracranial Arteriovenous Malformation in China

This register study will collect the treatment information of the intracranial arteriovenous malformation patients in China. We aim to understand the current treatment situation of the disease in China.

Intracranial arteriovenous malformations are congenital lesions that consist of multiple arteries and veins, connecting as a fistula without intervening normal capillary bed. The treatment strategy including surgical removal, endovascular embolism and stereotaxic radiosurgery and comprehensive treatment. China is a united multi-ethnic nation of 56 ethnic groups, and has the largest population in the world. We have most extensive and valuable clinical resources of intracranial arteriovenous malformation in the world. But we know little about the current treatment situation of the disease in China.

In order to realize the treatment situation of intracranial arteriovenous malformation in China, we designed a retrospective and prospective register study to collect the treatment and outcome information all over China.

Eligibility Criteria:
Inclusion Criteria:

* All the patients that diagnosed of intracranial AVM by DSA/CT/MRI
* All patients gave written informed consent

Exclusion Criteria:

* patients refuse to attend the survey
Evaluation of Fondaparinux in Patients With a Heart Rhythm Disturbance Who Undergo Restoration of Normal Heart Rhythm

The purpose of this study is to test whether Fondaparinux is effective and safe to prevent thromboembolic events (like for example strokes) and bleeding events in patients who undergo a normalisation of their heart rhythm disturbance. Fondaparinux will be compared with Heparin and tablets containing Vitamin-K-Antagonists (Phenprocoumon, Fluindione, or Warfarin).


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged at least 18 years with atrial fibrillation (AF) meeting at least one of the following criteria (a, b, c): a. Acute clinical symptoms (like palpitations, chest pain, dyspnea, fatigue, lightheadedness, or syncope) for at least 48 hours and AF on baseline ECG b. Newly discovered AF persisting for \>=7 days c. Recurrent AF persisting for \>=7 days

Exclusion Criteria:

* No documented sinus rhythm on ECG for more than 1 year
* Acute neurological deficits (TIA, stroke, intracranial bleeding), or known disease which may cause neurological deficits (e.g., multiple sclerosis, seizure disorder)
* Treatment with antithrombotic agents, including low-dose anticoagulation, for more than 48 hours prior to randomisation
* Treatment with oral NSAIDs or ASA at doses greater than 325 mg per day for more than 72 hours prior to randomisation
* Anticoagulant therapy required or likely to be required during the study period
* Treatment with ASA at a dose greater than 325 mg per day or oral NSAIDs (at any dose) required or likely to be required during the study period
* Treatment with two or more antiplatelet agents (e.g. clopidogrel and ASA) at any dose at the same time (i.e., within 24 hours)
* Known hypersensitivity to UFH, VKA, or Fondaparinux or one of these drugs' excipients
* Active, clinically significant bleeding or clinically significant bleeding within the past month
* Major surgery within the previous three months
* Uncontrolled arterial hypertension (persistent systolic blood pressure over 180 mm Hg or diastolic blood pressure over 110 mm Hg)
* Bacterial endocarditis
* Calculated creatinine clearance \< 30 mL/min
* Body weight \< 50 kg
* Planned surgery or intervention within the next 65 days
A Study of Herceptin (Trastuzumab) in Patients With Metastatic or Advanced Gastric Cancer With Disease Progression

This study will evaluate the efficacy and safety of Herceptin in patients with metastatic or advanced gastric cancer with disease progression during platinum-based or 5-fluoropyrimidine-based chemotherapy. The anticipated time on study treatment is until disease progression.


Eligibility Criteria:
Inclusion Criteria:

* adult patients 18-75 years of age;
* metastatic or advanced gastric cancer;
* disease progression under or after 1 prior platinum-based or 5-fluoropyrimidine-based chemotherapy for metastatic disease;
* \>=4 weeks from last platinum-based or fluoropyrimidine-based chemotherapy;
* \>=1 measurable lesion;
* HER2 overexpression (IHC \[2+\] or \[3+\]).

Exclusion Criteria:

* concurrent chemotherapy or immunotherapy;
* brain or meningeal metastases;
* clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;
* co-existing malignancies or malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ;
* women who are pregnant or breastfeeding.
Safety and Pharmacokinetics of Linzagolix in Female Subjects With Normal and Impaired Renal Function

The primary objective of this study is to assess the pharmacokinetics (PK) of linzagolix in subjects with varying degrees of impaired renal function compared to matched control subjects with normal renal function

This is a Phase 1, non-randomized, open label, single-dose study to evaluate the effect of varying degrees of impaired renal function (i.e., mild, moderate, severe Renal Impairment (RI), and End-Stage Renal Disease (ESRD) on hemodialysis) on the PK, safety, and tolerability of linzagolix and its major metabolite, KP017.

Up to 40 adult female participants will be enrolled.

Eligibility Criteria:
Key Inclusion Criteria:

Renal Impaired Subjects

1. Adult female, ≥ 18 years of age at screening
2. Has a BMI ≥ 18.0 and ≤ 42.0 kg/m\^2 and weight ≥ 40 kg, at screening
3. Aside from RI, be sufficiently healthy for study participation based upon medical history, physical examination, vital signs, electrocardiograms (ECGs), and screening clinical laboratory profiles, as deemed by the Principal Investigator (PI) or designee

   Subjects with mild, moderate, or severe RI:
4. Has estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) equation at screening as follows:

   * Severe RI only: ≤ 29 mL/min/1.73m\^2 not on hemodialysis
   * Moderate RI only: 30 - 59 mL/min/1.73m\^2
   * Mild RI only: 60 - 89 mL/min/1.73m\^2
5. Has a stable renal function with no clinically significant change in renal status at least 1 month prior to study drug administration and is not currently or has not been previously on hemodialysis for at least 1 year

   Subjects with ESRD:
6. Subject is maintained on a stable hemodialysis regimen at least 3 times a week for at least 3 months prior to dosing

Healthy Subjects

1. Health adult female will be matched to subjects with RI
2. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee
3. Baseline eGFR ≥ 90 mL/min/1.73m\^2 at screening, based on the MDRD equation. Actual creatinine clearance, as determined by a 24-hour urine collection, may be used in place of or in conjunction with the MDRD equation at the PI's discretion

Key Exclusion Criteria:

Renal Impaired Subjects

1. Had any major surgery within 4 weeks prior to dosing
2. Presence of functioning renal transplant
3. Has a surgical (e.g., hepatectomy, nephrectomy, digestive organ resection) or medical condition other than RI which might significantly alter the absorption, distribution, metabolism, or excretion of linzagolix and its metabolites, or which may jeopardize the subject's safety in case of participation in the study, in the opinion of the PI or designee

Healthy Subjects

1. Has any clinically significant illness, as judge by the PI or designee, within 4 weeks prior to dosing
2. Has laboratory values at screening or check-in which are deemed to be clinically significant (especially derangement within liver function test), unless agreed in advance by the PI and the Sponsor
CAPEOX vs Observation in Colorectal Cancer Patients With Positive MRD

Patients with stage Ⅰ colorectal cancer or stage Ⅱ colon cancer usually have a good prognosis and are not recommended to receive adjuvant chemotherapy after radical surgery. With the advances in liquid biopsy technology, detection of circulating tumor DNA (ctDNA) can effectively identify early-stage cancer patients with minimal residual disease (MRD) after surgery. According to the growing number of MRD studies in solid tumor, colorectal cancer patients with ctDNA-MRD detection have a poor clinical outcome and are likely to relapse within two years. This study aims to assess the efficacy of adjuvant chemotherapy with capecitabine plus oxaliplatin (CAPEOX) compared with conventional observation in MRD-positive patients with stage I colorectal cancer and clinically low-risk stage II colon cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Colorectal cancer confirmed by pathology, and the TNM stage (AJCC v8) is stage I or stage II. Stage II patients have T3 colonic adenocarcinoma with proficient mismatch-repair system (by immunohistochemistry for four mismatch repair proteins MSH1, MSH2, MSH6, and PMS2) and have no the following clinical risk factors: a) less than 12 lymph nodes examined; b) mucinous carcinoma; c) poor differentiation; d) bowel obstruction or perforation; e) lymphatic/vascular invasion, perineural invasion; f) close, indeterminate, uncertain, positive margins
2. ECOG performance status 0-1
3. No neoadjuvant therapy before surgery
4. Appropriate for active surveillance (i.e., no adjuvant chemotherapy) based on current practice patterns or according to the Chinese Society of Clinical Oncology guidelines for Colorectal Cancer (version 2022)
5. No history of other primary cancers in the past 3 years
6. No history of bone marrow, stem cell or organ transplant
7. Blood samples from 7 to 21 days after surgery were tested positive for ctDNA (tested by MinerVa MRD assay)
8. Pregnancy test done within 14 days before randomization must be negative (for women of childbearing potential only)
9. Voluntarily join the study and sign the informed consent document
10. No unstable or any medical condition that affects patient safety and study compliance evaluated by researchers
11. Availability and provision of adequate surgical tumor tissue for molecular diagnostics

Exclusion Criteria:

1. Patients with multiple primary colorectal cancers
2. Patients with another primary cancer
3. Patients have the following conditions by blood test, or have obvious contraindication in adjuvant chemotherapy:

   1. Moderate/severe renal impairment (GFR\<30 ml/min), as calculated by the Cockcroft and Gault equation
   2. Absolute neutrophil count \<1.5×109/L
   3. Platelet count \< 75×109/L
   4. Hemoglobin \<90 g/L
   5. Aspartate aminotransferase/Alanine aminotransferase \>2.5 × upper limit of normal
4. Lactating women
5. Have serious or uncontrolled medical condition that may preclude compliance with the protocol
Early Rehabilitation After Immediate Reconstruction With TEI in Breast Cancer Patients

The purpose of the study is to find best post-operative rehabilitation protocol after total mastectomy and immediate reconstruction with tissue expander insertion. This study compared outcomes of two post-operative rehabilitation protocols ; "conventional protocol", which immobilized shoulder and upper arm motion for a month and "early rehabilitation protocol" with short-term immobilization period and early mobilization.

To prevent surgical site complications, surgeons use so-called "conventional protocol", which immobilizes shoulder and upper arm motion for a month after total mastectmoy and immediate reconstruction with tissue expander insertion. To improve shoulder mobility and QOL of patients, the investigators introduced a new and early rehabilitation protocol with short-term immobilization in Jan 2017.

The investigators retrospectively reviewed total 115 breast cancer patients who underwent reconstructive surgery from May 2016 to Aug 2017. Patients who did their reconstruction before Jan 2017 followed conventional protocol and immobilized their shoulder for more than 4 weeks. Patients who did their reconstruction after Jan 2017 were educated to undergo a self-exercise program after short-term immobilization of 2 weeks. The investigators reviewed shoulder mobility, pain, QOL and complications at postoperative 1 month and 2 month in both group of patients.

Eligibility Criteria:
Inclusion Criteria:

* Subject has breast cancer
* Subject underwent total mastectomy and immediate reconstruction with tissue expander insertion

Exclusion Criteria:

* Patients who had pre-existing conditions before breast cancer surgery that limit shoulder movement.
Evaluation of a Cohort of Patients With Ehlers-Danlos Syndrome Treated With Orthopedic Surgery (SED-eval)

The aim of this study is to assess the joint involvement (shoulder - ankle - knee - elbow - wrist) in patients with Ehlers-Danlos Syndrome and treated by surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years-old suffering from Ehlers-Danlos Syndrome and belonging to the EDS cohort of Raymond Poincaré Hospital in Garches
* Patient with joint involvement of the shoulder treated by surgery
* Patient with ankle joint damage treated by surgery
* Patient with joint damage to the knee treated by surgery
* Patient with elbow joint damage treated by surgery
* Patient with joint involvement of the wrist treated by surgery
* Patient affiliated or beneficiary of a social security scheme
* Patient who has been informed of the research and does not object to the use of his data.

Exclusion Criteria:

* Patient objecting to the use of their data
Hybrid APC for Gastric Low Grade Intraepithelial Neoplasia

This cohort study aims to investigate the clinical efficacy and safety of Hybrid APC for treatment of gastric low grade intramucosal neoplasia.

This cohort study aims to investigate the clinical efficacy and safety of Hybrid APC for treatment of gastric low grade intramucosal neoplasia. Successful ablation is defined as no evidence of local recurrence at 12 months after HybridAPC upon follow up endoscopy. This is defined as absence of LGIN, HGIN and cancer in biopsies obtained at all locations during followup endoscopy.

Eligibility Criteria:
Inclusion Criteria:

1. Low grade intraepithelial neoplasia of stomach with size≤20 mm
2. Endoscopic diagnosis suspected gastric LGIN with biopsy confirmed gastric LGIN
3. Endoscopic appearance according to Paris classification of Type 0-IIa, IIb or IIc
4. Patients with informed consent

Exclusion Criteria:

1. Patients who had previous endoscopic treatment (including APC, EMR, ESD) for gastric LGIN, HGIN or gastric carcinoma.
2. Endoscopic evidence of ulcer
3. Biopsy confirmed HGIN
4. Endoscopic diagnosis suspected HGIN while biopsy confirmed LGIN
5. Pregnancy
6. informed consent not available