cyrilzakka/clinical-trials huggingface dataset:
Systemic Therapy Sequenced Isolated PALND for mCRC

The study aims to estimate the efficacy and safety of systemic therapy sequenced radical surgery in treating patients with synchronous isolated para-aortic lymph node metastasis of colorectal cancer.

Patients with synchrnous isolated para-aortic lymph node metastasis of colorectal cancer receiving systemtic therapy (at most two lines), radiologically assessed efficacious, and assessed by MDT that are potential to reach no evidence of disease (NED) were included in our trial. All included patients receive para-aortic lymph node dissection.

Eligibility Criteria:
Inclusion Criteria:

1. Age at enrollment is \>= 18 and \<= 75 years
2. ECOG PS 0-1
3. Histologically confirmed colorectal carcinoma
4. Synchronous metastatic colorectal cancer with isolated para-aortic lymph node metastases: In the preoperative examination of positron emission tomography CT and abdominopelvic CT, metastasis was noted when the diameter of the PALN was 10 mm or greater and had irregular shape.
5. Single-organ para-aortic lymph node metastasis (PLANM) who are potential to receive surgery and achieve no evidence of disease (NED).
6. Adequate liver, renal and bona marrow function.
7. Signing written informed consent

Exclusion Criteria:

1. In addition to PALN metastasis, distant metastases such as lung, liver, peritoneum and bone were presen and in instances when the renal vein was in the upward spread path of the LN metastasis.
2. Unable to achieve NED
3. Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention, Or a history of myocardial infarction in the last 12 months.
4. Those with other history of malignant disease in the last 5 years, except for cured skin cancer and cervical carcinoma in situ.
5. Organ transplantation requires immunosuppressive therapy
Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care

Comfort evaluation is one of the major challenges in the palliative care setting, particularly when it comes to non-communicative patients. ANI monitoring is a non-invasive and painless technique which evaluates the parasympathetic tone activity through heart rate variability. It has proven reliable for pain assessment during general anesthesia (GA) or for sedated critically ill patients. The parasympathetic activity seems to be a good reflect of the patient's comfort, implicating stress and anxiety.

So, the ANI could be an interesting tool to assess the comfort of non-communicating end-of-life patients.

That is why the goal of our study is to assess the interest of ANI to assess the comfort of non-communicating patients hospitalized in palliative care during a painful care by comparing the ANI measure to the CPOT scale realised by the nurses in a blind manner.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized in palliative care Non-communicating patients (Glasgow ≤ 10)

Exclusion Criteria:

* Non sinusal heart rate
* Respiratory rate \< 9/min
* Treated by inotropes
* Pace-maker
* Patient in agonal phase
* Opposition from the guardian
Efficacy and Safety of AC102 Compared to Steroids in Adults with Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL)

The purpose of this Phase 2 clinical trial is to evaluate the safety, tolerability and efficacy of AC102 administered as single intratympanic injection compared to oral steroid treatment in patients with Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL).


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged between 18 and 85 years
* Unilateral ISSNHL
* Onset of unilateral ISSNHL between 24 to 120 hours prior to randomization
* An absolute air conduction hearing threshold of at least 65 dB,
* Patients with a relative hearing loss of at least 30 dB compared to the current audiogram of the non-affected ear

Exclusion Criteria:

* Insufficient handling of the language used in the speech audiometry tests
* Bilateral hearing loss
* Acute hearing loss from noise trauma, barotrauma or head trauma in either ear at any time
* Congenital hearing loss
* Conductive hearing loss or combined hearing loss determined by a 4PTA \> 10 dB
* History of ISSNHL in the past 1 years in the affected ear
Panobinostat (LBH589): Acute Graft Versus Host Disease (aGVHD) Prevention

This study will test PANO in combination with tacrolimus/sirolimus (TAC/SIR) for acute GVHD prevention. The purpose of this study is to determine if Panobinostat (PANO) when used in combination with sirolimus and tacrolimus will help reduce the incidence of Graft-vs-host disease (GVHD).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years or older at time of enrollment
* Signed informed consent
* Hematologic disorder requiring allogeneic hematopoietic cell transplantation
* Left ventricular ejection fraction (LVEF) ≥ 45% by multiple uptake gated acquisition (MUGA) scan or echocardiogram
* Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and diffusing lung capacity oxygenation (DLCO) adjusted ≥ 50% of predicted values on pulmonary function tests
* Transaminases (AST, ALT) \< 3 times upper limit of normal (ULN) values
* Creatinine clearance calculated ≥ 50 mL/min
* Karnofsky Performance Status Score ≥ 60%.
* Human leukocyte antigen (HLA) matched 8/8 (A, B, C, DRB1) related or unrelated donor

Exclusion Criteria:

* Active infection not controlled with appropriate antimicrobial therapy
* HIV, hepatitis B (HBcAb positive but HBsAg negative with undetectable viral load are eligible), or hepatitis C infection
* Sorror's co-morbidity factors with total score \> 4. Important modification to co-morbidity index calculation: DLCO adjusted will not be included in assessment of pulmonary risk, except those patients with DLCO adjusted \< 50% who are excluded from the trial.
* Anti-thymocyte globulin (ATG) as part of the conditioning regimen
* Cyclophosphamide as part of the conditioning regimen or for GVHD prophylaxis
* Pregnancy
* Histone deacetylase (HDAC), DAC, HSP90 inhibitors or valproic acid for the treatment of cancer within 30 days
* Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first PANO treatment
* Impaired cardiac function or clinically significant cardiac diseases, including any one of the following: Any history of ventricular fibrillation or torsade de pointes; Bradycardia defined as heart rate (HR)\< 45 bpm (Patients with pacemakers are eligible if HR ≥ 45 bpm); Screening electrocardiogram (ECG) with a QTcF \> 480 msec; Right bundle branch block + left anterior hemiblock (bifascicular block); Patients with myocardial infarction or unstable angina ≤ 12 months prior to starting study drug; Other clinically significant heart disease (e.g., New York Heart Association (NYHA) class III or IV , uncontrolled hypertension) as per discretion of principal investigator and/or treating physician; Patients using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug with the exception of drugs listed on Appendix B of study documents that are required for hematopoietic cell transplantation (HCT) patients.
Phenotype/Genotype Correlation in a Family With Early Onset Osteoarthritis

This study will investigate the genes responsible for osteoarthritis. Individuals with osteoarthritis known or suspected to be caused by a gene mutation (change) may be eligible for this study. Family members may also participate.

Patients will talk with investigators who will explain the study and its possible implications for the patient and family and answer questions. The patient's medical records will be reviewed, a personal and family history will be taken, and a physical examination will be done. Two procedures may be done including blood sampling (which will be used for DNA (genetic) studies) and X-rays (to define osteoarthritis grade).

If no known mutations responsible for osteoarthritis will be detected, participating family members will be interviewed by telephone about their personal and family health history and will have a blood sample drawn for DNA testing, and X-rays.

We will investigate the clinical manifestations and molecular genetic defects of human osteoarthritis. Families with osteoarthritis of known or suspected genetic basis will be enrolled. Individuals will undergo clinical assessment and genetic analyses for the purpose of: 1) definition and characterization of phenotype, 2) determination of the natural history of the disorder, and 3) genotype/phenotype correlation. Genetic linkage studies may be performed for disorders in which the genetic bases is not yet known.

Eligibility Criteria:
Inclusion Criteria:

* Individuals (and family members) with early onset osteoarthritis according to the following definition:

  * symptomatic OA before 50 years old
  * no obvious causes of OA (IMC \> 30, dysplasia,joint traumas)
  * at least three OA locations

Exclusion Criteria:

* Individuals younger than 18 years old.
B2 Adrenergic Receptor Gene Polymorphism in Bronchial Asthma

The b2-adrenoceptor (b2AR) mediates the physiological responses in the airway, which include bronchodilation, bronchoprotection. The b2-adrenoceptor (b2AR) mediates the physiological responses in the airway, which include bronchodilation, bronchoprotection, Enhanced mucociliary clearance.

The b2AR gene is located on chromosome 5q31-q32, a region that is genetically linked to asthma and related phenotypes. There are three best known polymorphisms in the coding region of the b2AR gene that can modulate the function of the receptor.

Asthma is a complex disease and has a strong genetic component in its pathogenesis. So far, considerable efforts have been made to evaluate the association between genetic variants and asthma risk, and numerous genes have been identified as asthma Reporting Items susceptible genes.

The b2-adrenoceptor (b2AR) mediates the physiological responses in the airway, which include bronchodilation, bronchoprotection. The b2-adrenoceptor (b2AR) mediates the physiological responses in the airway, which include bronchodilation, bronchoprotection, Enhanced mucociliary clearance.

The b2AR gene is located on chromosome 5q31-q32, a region that is genetically linked to asthma and related phenotypes. There are three best known polymorphisms in the coding region of the b2AR gene that can modulate the function of the receptor.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed as asthma according to GINA guideline 2016.
* Allergic asthma

Exclusion Criteria:

* pneumonia
* chronic cardiac, hepatic and renal diseases
* pregnancy and lactation
* malignancy
The Relationship Between Right-to-left Shunt and Brain White Matter Lesions in Patients With Migraine

The purpose of the study is to evaluate the prevalence of white matter lesions in Chinese migraineurs with and without right-to-left shunt. The aim is to study the relationship among right-to-left shunt, migraine and white matter lesions.

This is a prospective multicenter study of Chinese population. Participants (normal individuals without migraine and migraineurs) are included after standardized diagnostic procedures (TCD and migraine diagnosis). For all the participants, brain MRI and c-TCD are required. Up to 10-15 study sites nationwide will be needed to recruit the planned participant population during a 1-year period.

The information of each participants will be registered, including basic facts, the longitudinal headache history, frequency, location, quality, intensity, duration, accompanied symptoms, precipitating and exacerbating factors, with or without aura, and Headache Impact Test-6 (HIT-6) questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* patients who fulfilled the criteria for migraine according to the International Classification of Headache Disorders III-beta were included.

healthy volunteers without a history of migraine were included as controls.

Exclusion Criteria:

* Subjects were excluded from the study if they had severe arterial stenosis, an insufficient temporal window, inadequate cubital venous access, and/or were unable to perform the Valsalva manoeuvre (VM) because of severe heart or lung disease.
Fertility in Untreated Rectosigmoid Endometriosis

Several studies investigated the reproductive outcomes after surgical treatment of colorectal endometriosis, mainly segmental colorectal resection. Little information is available on the spontaneous fertility of patients with bowel endometriosis. This study aims to evaluate the fertility of patients affected by rectosigmoid endometriosis who did not undergo previous surgical treatment.


Eligibility Criteria:
Inclusion Criteria:

* Desire of conception
* Diagnosis of rectosigmoid endometriosis by transvaginal ultrasonography (TVS) and magnetic resonance imaging enema (MR-e)

Exclusion Criteria:

* Previous surgery for endometriosis
* Diagnosis of hydrosalpinx at imaging
* Previous conception
* Abnormal semen parameters of male partners
Hood to Coast Injury Study

The purpose of this study is to examine how certain kinds of fruit juice that contain natural antioxidants and natural anti-inflammatory properties may reduce exercise-induced muscle pain and injury. Participants will be recruited from registered participants in the Hood To Coast Relay. The Hood To Coast Relay Race Officials will post the study on their website to find interested teams. Interested participants will then be contacted by the study staff by phone regarding the study's inclusion and exclusion criteria and to schedule the initial health screening visit. The participants will undergo an initial health screening and survey about muscle soreness, and then drink the investigational juice twice daily for 8 days. On the 7th day of drink administration, the participants will report to the starting location of the Hood To Coast Relay to meet with the investigators for 30 minutes to survey muscle pain and juice tolerability. The participants will then participate in the Hood To Coast Relay, drinking 2 more bottles of juice over the duration of the relay. At the conclusion of the relay, the participants will meet with study investigators to take the same short survey about muscle pain and juice tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Ability and willingness not to take any anti-inflammatory or pain relieving drugs during the course of the study, and not to seek any other treatment for any symptoms of muscle damage until completion of the study after the race.

Exclusion Criteria:

* The investigators will exclude individuals who have or are using antiepileptic drugs for pain, acupuncture, or transcutaneous electrical nerve stimulation within 3 weeks before enrollment
* Recent use (within 5 half-lives) of topical medications/anesthetics, muscle relaxants, tender point anesthetic injections within 2 months, systemic steroids within 3 months or any investigational drug/device in the prior 30 days.
Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery

The primary objective was to demonstrate the dose-response of Semuloparin sodium (AVE5026) for the prevention of Venous Thromboembolism \[VTE\] in patients undergoing total knee replacement \[TKR\] surgery.

Secondary objectives were to evaluate the safety (incidence of major bleeding) of AVE5026, to document the efficacy and safety of AVE5026 post-operative regimens, and to assess the pharmacokinetic parameters of AVE5026.

The randomization had to take place before the first study drug injection.

The total duration of observation per participant was 27-33 days from surgery broken down as follows:

* 4 to 10-day double-blind treatment period;
* Follow-up period up to Day 30 ± 3 after surgery.

Mandatory bilateral venography of the lower limbs had to be performed between 5 to 11 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled to undergo elective total knee replacement or revision of a primary procedure performed ≥ 6 months prior to study entry.

Exclusion Criteria:

* Any major orthopedic surgery in the 3 months prior to study entry;
* Clinical signs or symptoms of DVT or PE within the last 12 months or known post-phlebitic syndrome;
* Known sensitivity to iodine or contrast dyes;
* Recent stroke or myocardial infarction;
* High risk of bleeding;
* Treatment with other anti-thrombotic agents within 7 days prior to surgery;
* Any contra-indication to Unfractionated Heparin or Low Molecular Weight Heparin;
* Pregnant or nursing woman, or woman of childbearing potential who is not using an effective contraceptive method.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Provider Notification for High B-type Natriuretic Peptide Values

This proposal examines use of a clinical reminder to the primary provider of patient with a high B type natriuretic peptide but no prior imaging.

Electrical Medical Record-based Intervention to Determine whether Clinical Reminders Improve Heart Failure Management in Patients with High BNP Values and Unknown LVEF.

Rationale: B type natriuretic peptide is known to be elevated (\> 100 pg/ml) in patients with heart failure. Furthermore, treatments are available to improve survival and reduce hospitalization if the left ventricular ejection fraction (LVEF) is \< 40%. Accordingly, guidelines recommend an LVEF measure for patients with suspected heart failure. Prior work has demonstrated that patients with high BNP values do not always have a measure of left ventricular ejection.

Hypothesis: A reminder to patients with BNP and no imaging may prompt providers to order appropriate imaging potentially leading to 1) identification of unsuspected depressed ejection fraction and 2) more appropriate treatment.

Eligibility Criteria:
Inclusion Criteria:

* BNP \>= 200 pg/ml in last 2 months

Exclusion Criteria:

* Measure of LVEF in the last 12 months
* Last measure of LVEF \< 40%
PFA for Paroxysmal Atrial Fibrillation

The purpose of this study is to verify the safety and efficacy of the cardiac pulse ablation system in paroxysmal atrial fibrillation to provide the basis for product registration and clinical application.

The trial will be conducted at a clinical center with appropriate clinical cases, and paroxysmal atrial fibrillation ablation procedures will be performed by an authorized investigator using the trial product. The effectiveness and safety of the cardiac pulse ablation system in the treatment of paroxysmal atrial fibrillation will be verified by collecting the treatment success rate, immediate ablation success rate, procedure time and device use evaluation within 12 months after the procedure.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 and ≤75 years of age.
* Paroxysmal atrial fibrillation diagnosed by electrocardiogram or Holter ECG (including single-lead ECG recorder, lasting≥30s) within 1 year prior to enrollment.
* Clinical diagnosis of paroxysmal atrial fibrillation.
* Symptomatic patients who are ineffective or intolerant to at least one antiarrhythmic medication; or patients who are willing to undergo ablation despite not being on medication.
* Fully understand the treatment protocol and voluntarily sign the informed consent form and be willing to undergo the tests, procedures and follow-ups required by the protocol.

Exclusion Criteria:

* Patients who have undergone left atrial surgery
* Left atrial thrombosis
* Patients of childbearing age who are unable to use effective contraception during the 12-month period after enrollment
* Anterior and posterior left atrial diameter ≥ 50 mm
* Left ventricular ejection fraction (LVEF) ≤ 40%
* Previous atrial septal repair or atrial mucinous tumor
* Active implants (e.g. pacemakers, ICDs, etc.) in the body
* NYHA class III-IV cardiac function \[Appendix 1\]
* Clear cerebrovascular disease within the last 6 months (including cerebral hemorrhage, stroke, transient ischemic attack)
* Cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventriculotomy)
* Those with acute or severe systemic infections
* Patients with severe liver or kidney disease, malignant tumors or end-stage disease that, in the opinion of the investigator, may interfere with the treatment, evaluation and compliance of this trial
* Patients with significant bleeding tendency, hypercoagulable state and severe hematologic disorders
* Patients who have participated or are participating in other clinical trials within 3 months prior to enrollment
* Patients who have other conditions that the investigator considers inappropriate for participation in this trial.
Efficacy of TECAR Therapy in Patients With Knee Osteoarthritis

Objective: The aim of the present study was to investigate the treatment efficacy of TECAR therapy, a modern application that has been increasingly used in recent years, compared to conventional physical therapy applications in the treatment of knee osteoarthritis, according to the evaluation of the clinical findings of patients.

Methods: A total of 54 patients, aged between 40 and 75 years, were randomly divided into two groups. Both groups received CPT. Group 2 received TECAR therapy in addition to CPT, applied three times a week for two weeks, for a total of 6 sessions. All patient's knee joint range of motion (ROM) was measured goniometrically, isometric quadriceps muscle strength was measured, and pain levels were assessed using the Visual Analog Scale (VAS), and disability levels were assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) before treatment, at the end of treatment, at 1 month, and at 3 months.


Eligibility Criteria:
Inclusion Criteria:

* 3 months of conservative treatment for unresponsive knee pain
* Kellgren-Lawrence grade 2-3 on radiographic evaluation
* Agreed to participate in the study.

Exclusion Criteria:

* History of physical therapy (electrotherapy/exercise) in the past 3 months
* Intra-articular injection therapy in the past 3 months,
* History of surgery or trauma to the affected knee
* Inflammatory or neurological disease affecting the lower extremities
* Active vasculitis or severe peripheral vascular disease
* Pregnancy or lactation
* Diagnosed restless legs syndrome
* Neoplasia
* Local sensory impairment,
* Local or systemic acute infections
* Severe osteoporosis
* Pacemaker
* Psychiatric disorder and cognitive impairment.
An Exploratory Investigation of a Supplement to Promote Cognitive Health Benefits

The Smart Supplement has 20 vitamins and minerals that have strong track records of demonstrating positive health effects, both physiologically and cognitively. This twelve-week trial will examine the effectiveness and efficacy of Heights Smart Supplement on both biomarkers and subjective experiences from participants.


Eligibility Criteria:
Inclusion Criteria:

* In good general health with no major chronic conditions
* Must experience one of the following issues: brain fog
* OR issues with fatigue,
* OR sleep issues,
* OR trouble with focus and concentration,
* OR lead a busy, stressful life.
* Must have a fitness tracker that they use to track sleep behaviors.
* May be on a vegan/vegetarian diet

Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Anyone currently taking other supplements focused on brain health, or multi vitamins, including additional iron supplements
* Anyone taking Thyroxine and Levothyroxine
* Anyone taking antidepressants (such as Sertraline or SSRIs like fluoxetine)
* Anyone on hormone replacement therapy
* Anyone taking blood pressure medication (such as linosipril)
* Anyone with a known allergic reaction
* Any chronic conditions, including oncological and psychiatric disorders