cyrilzakka/clinical-trials huggingface dataset:
Supermicrosurgery for Breast Cancer Survivors With Lymphedema.

A randomised prospective investigation of volume and quality of life results with lymphovenous anastomosis in patients with unilateral arm lymphedema after breast cancer using Indocyanine Green lymphangiography and MD Anderson Staging.

This is a randomized study comparing lymphovenous anastomosis versus conservative (compression) treatment for lymphoedema after breast cancer surgery - 50 patients to be included in each study arm. The primary endpoint is volume change measured by submersion and changes in arm circumference at defined levels from the wrist. Secondary endpoint is health related quality of life measured by questionnaire Short Form 36 (SF-36), Hospital Anxiety Depression Score (HADS), Fatigue Questionnaire (FQ) and a disease-specific questionnaire, Upper Limb Lymphedema score (ULL27).

Eligibility Criteria:
Inclusion Criteria:

* Unilateral lymphedema of the arm secondary to breast cancer treatment. Stage 1-3 operable lymphedema.

Exclusion Criteria:

* Frequent or severe cellulitis. All other lymphedema.
Total Antioxidant Capacity Before and After HRT in Hypotalamic Amenorrhea

The aim of our study is to investigate the effects of 6 months oh HRT on total anti-oxidant capacity, clinical, endocrine and metabolic features in women affected by hypotalamic amenorrhea. The study group included 20 patients treated with 1 mg of transdermal estradiol daily and 10mg of oral Medroxyprogesterone acetate from 16th to 24th day of therapy for six months. Menstrual pattern, anthropometric parameters, hormonal assays, DXA and bone metabolism parameters are evaluated before and after therapy.


Eligibility Criteria:
Inclusion Criteria:

* Hypotalamic Amenorrhea

Exclusion Criteria:

* diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test)
* hypertension
* significant liver or renal impairment
* other hormonal dysfunction (hypothalamic, pituitary, PCOS, thiroidal or adrenal)
* neoplasms
PD-1 Antibody and Lenvatinib Plus TACE on Downstaging BCLC B/C HCC

The purpose of this study is to assess the difference of safety and efficacy about PD-1 Antibody and Lenvatinib Plus transcatheter arterial chemoembolization (TACE) on downstaging hepatocellular carcinoma with BCLC B/C.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old and ≤75 years old;
2. Clinically diagnosed as hepatocellular carcinoma, stage B/C of BCLC;
3. No history of severe arrhythmia or heart failure;
4. No history of severe ventilation dysfunction or severe pulmonary infection;
5. No acute or chronic renal failure, the creatinine clearance rate was \>40 mL/min;
6. Liver function Child A;
7. Blood routine: absolute neutrophils count ≥1.5×10\^9/L, Hb≥8.5g/L, PLT≥75×10\^9/L;
8. Coagulation function: INR≤2.3;
9. ECOG score \<2;
10. No local or systemic treatment, such as TACE, RFA, targeted drugs, traditional Chinese medicine, etc., before enrollment;
11. Expected survival ≥12 weeks;
12. At least one lesion can be measured and evaluated by CT/MRI according to RECIST 1.1 criteria;
13. Understand and sign the informed consent.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Patients with other malignant tumors;
3. patients with complicated mental illness;
4. patients who have participated in other clinical trials in the last three months;
5. known or suspected allergy to any drug related to the study;
6. Patients with positive immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
7. Patients treated with other targeted drugs, PD-L1 antibody and other immunotherapy or FOLFOX systemic chemotherapy after inclusion;
8. Patients with ≥1 + proteinuria indicated by urine routine will receive 24-hour urine protein detection, and patients with ≥1g 24-hour urine protein will not be included in the group.
9. Active autoimmune diseases that require systemic treatment (use of disease-alleviating agents, such as corticosteroids or immunosuppressants)
10. Patients with uncontrolled hepatitis B/C infection
11. Other conditions that the researcher considers not suitable for inclusion in this study
Post-Surgical Based Efforts to Reduce Preventable Readmissions and Optimize Length of Stay

The investigators believe that hospital readmissions for intermediate- to high-complexity surgeries can be reduced by remote patient monitoring follow-up post-discharge, which involves daily touchpoints with a clinical nurse, vital sign evaluation and a symptom directed communication escalation process.


Eligibility Criteria:
Inclusion Criteria:

* Adults (over 18 years of age)
* Undergoing one of the following inpatient elective surgery procedures: abdominal wall reconstruction, bariatrics, hepatectomy, pancreatectomy, aortic surgery, lower extremity bypass, esophagectomy and colectomy at Mayo Clinic Rochester.
* Must be willing to actively work with RPM nurses with vital sign capturing.

Exclusion Criteria:

* Have uncontrolled mental illness and/or drug or alcohol abuse
* Reside in a long-term care facility
* Are being actively followed by dialysis or transplant services
* Pregnant
* Are being actively treated for cancer, receiving chemo or radiation therapy during the remote monitoring
* Are identified as end-of-life by provider
* Have dementia, cognitive impairment, or physical condition that limits ability to use home remote monitoring equipment independently or interact with remote patient monitoring staff (unless a caregiver commits to assisting daily).
Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B

The purpose of this study is to compare the effectiveness of entecavir plus tenofovir combination therapy with that of entecavir monotherapy. Safety will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis B virus (HBV) infection (hepatitis B e antigen \[HbeAg\]-positive or negative) disease
* Nucleoside- and nucleotide-naive
* Males or females ≥16 years of age (or minimum age of consent in a given country)
* Compensated liver function
* HBV DNA \>1.72\*10\*5\*IU/mL (approximately 10\*6\*copies/mL) for HbeAg-positive participants
* HBV DNA \>1.72\*10\*4\*IU/mL (approximately 10\*5\*copies/mL) for Hbe-Ag-negative participants
* Alanine aminotransferase level ≥\*upper limit of normal (ULN) and ≤10\*ULN

Exclusion Criteria:

* Evidence of decompensated cirrhosis
* Coinfection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
* Laboratory values out of protocol-specified range
Postoperative Morbidity and Mortality After Cardiac Surgery

The local database results from a joint initiative of anesthesic, cardiology and cardiac surgery departements.Its purpose is to record in an exhaustive fashion all the interventions of cardiac surgery performed under extracorporeal circulation in adults at Bichat hospital.This database includes the preoperative characteristics of the patients, the type of surgery, the post-operative complications and the in-hospital mortality. The purpose of this observational study is to evaluate in-hospital morbidity and mortality for all types of cardiac surgery interventions and to analyze it according to the characteristics of the patients and the type of intervention.

The operative mortality is a key point of the risk-to-benefit ratio analysis before considering cardiac surgery. Operative risk evaluation in a single surgical center is a part of medical care quality assessment. It must be interpreted in the light of the local specificities, in particular the characteristics of the patients and the types of surgery. The local database results from a joint initiative of anesthesic, cardiology and cardiac surgery departements.Its purpose is to record in an exhaustive fashion all the interventions of cardiac surgery performed under extracorporeal circulation in adults at Bichat hospital.This database includes the preoperative characteristics of the patients, the type of surgery, the post-operative complications and the in-hospital mortality. The purpose of this observational study is to evaluate in-hospital morbidity and mortality according to the characteristics of the patients and the type of intervention. study population : inclusion criteria : patient 18 years or older with legal capacity, patients with non-objection to record his/her medical data during hospitalization. Methods: this is an observational prospective and monocentric study. The main objective is to report in-hospital mortality for all types of cardiac surgery performed in Bichat hospital . The secondary objectives are :1) to collect post-operative complications such as hemorrhagic or thromboembolic events or surgery site infections; 2) to analyze mortality rate and post-operative morbidities according to the type of surgery and the main patients' characteristics . 3) to calculate validated and currents risk score such as EuroSCORE I and II for each patient.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older and has legal capacity - cardiac surgery under extra corporeal circulation
* non objection to record medical information during hospitalization

Exclusion Criteria:

-
Neoadjuvant Icotinib With Chemotherapy for Epidermal Growth Factor Receptor(EGFR)-Mutated Resectable Lung Adenocarcinoma

Icotinib is a first-generation inhibitor of EGFR-tyrosine kinase inhibitor in patients with non-small-cell lung cancer (NSCLC). Here we will evaluate neoadjuvant Icotinib with chemotherapy prior to surgery, in patients with resectable stage II-IIIB N2 EGFR mutation-positive NSCLC. The primary endpoint is centrally assessed major pathological response at the time of resection. Secondary endpoints include pathological complete response, objective response rate, R0 resection rate at the time of resection, disease-free survival, and overall survival. Safety and tolerability will also be assessed.


Eligibility Criteria:
Key Inclusion Criteria:

* Written informed consent
* Male or female, aged ≥18 years and ≤75 years
* Histologically or cytologically documented lung adenocarcinoma with completely resectable disease (Stage II-IIIB N2, according to the 8th edition of the IASLC Staging Manual in Thoracic Oncology)
* Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by an MDT evaluation
* A tumor which harbors either Ex19del or L858R EGFR-TKI-sensitizing mutations, either alone
* ECOG PS 0/1 at enrollment, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing
* Adequate organ and marrow function as defined by:

  * Hemoglobin: ≥9.0 g/dL
  * Absolute neutrophil count: ≥1.5 × 109/l
  * Platelet count: ≥100 × 109/l
  * Serum bilirubin: ≤1.5 ULN
  * ALT and AST: ≤2.5 × ULN
  * Creatinine clearance: ≥60 ml/min
* Life expectancy of 6 months prior to randomization

Exclusion Criteria:

* Prior treatment with systemic anti-cancer treatment for NSCLC, EGFR-TKI treatment or pre-operative radiotherapy
* EGFR-TKI-sensitizing mutations with T790M
* Mixed small cell and non-small-cell lung cancer histology
* T4 tumors infiltrating the aorta, esophagus and/or heart
* Bulky N2 disease
* Candidates for segmentectomies or wedge resections only
* Medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment or any evidence of clinically active ILD
* Severe or uncontrolled systemic diseases/active infections, history of allogeneic organ transplantation, history of primary immunodeficiency, history of another primary malignancy
Clinical Study of HiR+X Therapy for Newly Diagnosed Elderly Patients with DLBCL Intolerant to Chemotherapy

To explore the application of HiR (Zebtorizumab, Lenalidomide) + X (targeted drug) guided by NGS molecular typing, the aim is to assess the therapeutic efficacy and safety in newly diagnosed unfit or frail elderly patients with DLBCL aged ≥70 years, and to investigate the genetic subtypes that may benefit from HiR-X.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 70 years;
2. ECOG score 0-3;
3. Rated as "unfit" or "frail" on the simplified geriatric assessment (sGA);
4. Histologically confirmed CD20-positive diffuse large B-cell lymphoma \[diagnostic criteria according to WHO 2016\], excluding transformed type 2 DLBCL;
5. Previously untreated, newly diagnosed patients;
6. Cardiac, hepatic, and renal function: creatinine \< 2 times the upper limit of normal (ULN); ALT (alanine aminotransferase) / AST (aspartate aminotransferase) \< 2.5 x ULN; total bilirubin \< 2 x ULN;
7. At least one measurable lesion;
8. Intolerance to standard CHOP chemotherapy regimen or unwillingness to receive chemotherapy;
9. Sufficient understanding and voluntary signing of the informed consent form.

Exclusion Criteria:

1. Patients with central nervous system involvement at the onset of the disease;
2. Known human immunodeficiency virus (HIV) infection;
3. Pregnant or lactating women;
4. Other tumors requiring treatment;
5. Uncontrolled active infection;
6. Active hepatitis with HBV-DNA copy number unable to be controlled within 2000/mL despite antiviral treatment;
7. Individuals who cannot understand, comply with the study protocol, or sign the informed consent form.
Subcostal Transversus Abdominis Plane Versus Epidural Block in Abdominal Surgeries

The investegators aimed to compare the efficacy of subcostal Transversus abdominis plane analgesia, to epidural analgesia intra and postoperatively in upper abdominal surgeries.

Epidural analgesia, once considered the gold standard for major abdominal surgeries, but is often associated with sympathetic blockade that creates hypotension and could therefore adversely affect the conduit. Epidural analgesia is recently replaced by other techniques with an improved risk benefit ratio. Pain management techniques that use peripheral nerve blockade are becoming more prevalent, reducing the need for an epidural. Transversus abdominis plane (TAP) approach is aimed to access the nerves in this neurofacial plane between internal oblique muscle and transversus abdominis through the lumbar triangle of Petit. Subcostal Transversus abdominis plane block, has been reported to provide analgesia for incisions extending above the umbilicus. However, there have been few clinical trials on the analgesic efficacy of continuous subcostal Transversus abdominis plane analgesia after major abdominal surgeries. It has been reported recently that supplemental magnesium has a role in providing perioperative analgesia, because this is a relatively harmless molecule, not expensive and because the biological basis for its potential antinociceptive effect is promising. No clinical studies have examined the effect of magnesium sulphate administered continuously in subcostal Transversus abdominis plane catheters as an adjunct to bupivacaine in postoperative analgesia.

The aim of this study is to compare the efficacy of subcostal Transversus abdominis plane analgesia, to epidural analgesia in major upper abdominal surgeries.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I, II or III
* The incision included is right subcostal incision for major upper abdominal surgeries (partial hepatectomy, pancreatic surgery included Whipple's procedure, total pancreatectomy and distal pancreatectomy) and other operations using the same incision.

Exclusion Criteria:

* Patient refusal.
* Hematological diseases.
* Bleeding diseases.
* Coagulation abnormality.
* Local skin infection
* Sepsis at site of the block.
* Known hypersensitivity to the study drugs.
* Body Mass Index \> 35 Kg/m2.
* If the lower end of the incision extended below T10 (umbilicus).
* If the incision extended laterally beyond the anterior axillary line or extended to pass the midline to the other side.
Cerclage for Twins With Short Cervical Length ≤ 15mm

This is a multicenter randomized study designed to determine if ultrasound indicated cerclage reduces the incidence of spontaneous preterm birth \<34 weeks in asymptomatic women with twin gestations and cervical length ≤15mm, diagnosed by transvaginal ultrasound between 16 to 23 6/7 weeks of gestation.

Twin pregnancies have 59% incidence of preterm delivery (before 37 weeks of gestation), with increased perinatal mortality and neonatal morbidity. No therapy has proven effective in preventing preterm birth in twins. The transvaginal cervical length (TVCL) performed before 24 weeks have been determined to be the best tool to identified women with twin pregnancy at risk of preterm birth (PTB). When short TVCL is identified before 24 weeks, the risk of preterm birth is 60%-70% for TVCL ≤25mm and 80%-90% for TVCL ≤15mm. There are a small number of case reports of cervical cerclage in twin pregnancies with cervical length ≤15mm that suggest decreased preterm birth by 80%. The investigators' objective is to determine if ultrasound indicated cerclage in reduces the incidence of spontaneous preterm birth \<34 weeks and improve perinatal outcome in asymptomatic women with twin gestations and cervical length ≤15mm between 16 to 23 6/7 weeks of gestation.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women more than 18 years of age (limits the participants to female gender)
2. Diamniotic twin pregnancy
3. Asymptomatic
4. Transvaginal cervical length ≤ 15 mm between 16-23 6/7 weeks gestation

Exclusion Criteria:

1. Singleton or higher order than twins multiple gestation
2. Transvaginal cervical length \>15mm
3. Cervical dilation with visible amniotic membranes
4. Amniotic membranes prolapsed into the vagina
5. Fetal reduction after 14 weeks form higher order
6. Monoamniotic twins
7. Twin-twin transfusion syndrome
8. Ruptured membranes
9. Major fetal structural anomaly
10. Fetal chromosomal abnormality
11. Cerclage already in place for other indication
12. Active vaginal bleeding
13. Clinical chorioamnionitis
14. Placenta previa
15. Painful regular uterine contractions
16. Labor
Hematopoietic Stem Cell Transplant for Dyskeratosis Congenita or Severe Aplastic Anemia

Fludarabine-based preparative regimen followed by an allogeneic hematopoietic stem cell transplant using related or unrelated donor in persons 0-70 years of age diagnosed with dyskeratosis congenita or severe aplastic anemia who have bone marrow failure characterized by a requirement for red blood cell and platelet transfusions. Three different preparative regimens are included based on disease and donor type.


Eligibility Criteria:
Inclusion Criteria:

* Aged 0 - 70 years
* Acceptable hematopoeitic stem cell donor
* Dyskeratosis Congenita (DC) with evidence of BM failure defined as:

  * requirement for red blood cell and/or platelet transfusions or
  * requirement for G-CSF or GM-CSF or erythropoietin or
  * refractory cytopenias having one of the following three

    * platelets \<50,000/uL or transfusion dependent
    * absolute neutrophil count \<500/uL without hematopoietic growth factor support
    * hemoglobin \<9g/uL or transfusion dependent
* Diagnosis of DC with a triad of mucocutaneous features:

  * oral leukoplakia
  * nail dystrophy
  * abnormal reticular skin hyperpigmentation, or
* Diagnosis of DC with one of the following:

  * short telomeres (under a research study)
  * mutation in telomerase holoenzyme (DKC1, TERT, TERC, NOP10, NHP2, TCAB1)
  * mutation in shelterin complex (TINF2)
  * mutation in telomere-capping complex (CTC1)
* Severe Aplastic Anemia (SAA) primary transplant with evidence of BM failure:

  * Refractory cytopenia defined by bone marrow cellularity \<50% (with \< 30% residual hematopoietic cells)
* Diagnosis of SAA with refractory cytopenias having one of the following three:

  * platelets \<20,000/uL or transfusion dependent
  * absolute neutrophil count \<500/uL without hematopoietic growth factor support
  * absolute reticulocyte count \<20,000/uL
* Severe Aplastic Anemia (SAA) requiring a 2nd transplant

  * Graft failure as defined by blood/marrow chimerism of \< 5%
* Early myelodysplastic features
* With or without clonal cytogenetic abnormalities
* Adequate organ function defined as:

  * cardiac: left ventricular ejection fraction ≥ 35% with no evidence of decompensated heart failure
  * pulmonary: DLCO ≥30% predicted, no supplemental oxygen requirement
  * renal: Glomerular filtration rate (GFR) ≥30% predicted
* Voluntary written consent

Exclusion Criteria:

* Acute hepatitis or evidence of moderate or severe portal fibrosis or cirrhosis on biopsy
* Pregnant or lactating
* Uncontrolled infection
* Prior radiation therapy (applies to SAA patients only)
* Diagnosis of Fanconi anemia based on DEB
* Diagnosis of dyskeratosis congenita with advanced MDS or acute myeloid leukemia with \>30% blasts
Comparison of Joint Awareness Between Fixed-bearing and Mobile-bearing Total Knee Arthroplasty Using Titanium-nitride Coated Posterior-stabilized Prostheses

Comparison of postoperative patient's joint awareness as well as clinical and radiological outcomes between fixed- and mobile-bearing total knee arthroplasty of which the prosthesis is coated with Titanium-nitride.

Despite numerous comparison studies between mobile- and fixed-bearing TKA as well as several comparison studies regarding clinical and radiological outcomes using titanium-nitride(TiN) prosthesis, there has been no study on postoperative joint awareness despite mobile- and fixed-bearing TKA using TiN prosthesis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with knee joint advanced osteoarthritis
* Age over 55 years old
* Scheduled to undergo primary total knee arthroplasty

Exclusion Criteria:

* Post-traumatic or inflammatory osteoarthritis
* Those who undertook previous ligamentous surgery
* Those who do not understand and give answers to a survey
SCREEN-HFL (SCReening Evaluation of the Evolution of New Heart Failure) - a Longitudinal Study

Heart failure (when the heart does not pump as well as it used to) is a medical condition which reduces the quality of life for the sufferers. Approximately 10% of people in western societies aged over 75 develop heart failure. There has been a shift towards prevention of this disease and it is hoped that BNP (brain natriuretic peptides) and NT-proBNP (N-terminal proBNP) will prove to be useful indicators of those at greatest risk. The current study therefore plans to follow up the 3500 participants at risk of heart failure from the original SCREEN-HF study.

Participants who are willing to participate will be contacted annually. They will undergo a short physical exam, will be asked to complete a Quality of Life questionnaire and will have a blood sample taken. At the end of the study participants will also have an ECG and an echocardiogram.


Eligibility Criteria:
Inclusion Criteria:

1. Consented and enrolled in the SCREEN-HF study and who agreed to further contact
2. Age ≥ 60 years
3. Subjects at high-risk of subsequent development of heart failure; comprising at least one of:

   * Prior myocardial infarction (MI) without known left ventricular (LV) dysfunction
   * Current active ischaemic heart disease
   * Prior Cerebrovascular Accident (CVA)
   * Known valvular heart disease without known LV dysfunction
   * Atrial fibrillation
   * Treated hypertension, of at least 2 years duration
   * Treated Diabetes mellitus, of at least 2 years duration
   * Chronic renal impairment (eGFR \< 60 ml/min)

Exclusion Criteria:

1. Known systolic or diastolic heart failure
2. LV systolic or diastolic dysfunction on echocardiography or other objective imaging modality (if known).