cyrilzakka/clinical-trials huggingface dataset:
Anatomy-based Resection or Margin-based Resection for Hepatocellular Carcinoma

Anatomical liver resection was widely accepted as first line curative therapy for hepatocellular carcinoma. However, number of retrospective clinical studies showed no priority of anatomical resection for hepatocellular, compared with non-anatomical resection.

Surgical resection margin is a essential factor that may affect tumor prognosis. It is controversial whether adequate liver resection margin is associated with improved survival outcome in patients with hepatocellular.

There was few prospective clinical trial to investigate whether anatomical liver resection is superior to non-anatomical resection or liver resection with adequate margin is superior to that with inadequate margin. This prospective clinical trial aims at fix these issues.

In the anatomical liver resection group, liver segmentectomy or lobectomy is performed to insure curative resection (R0 resection). The region of liver resected is based on the anatomy or portal vein and hepatic vein. The liver pedicle of the tumor located lobe is exposed and dissected, which is principle to perform anatomical liver resection.

In the non-anatomical liver resection group, the liver parenchyma transection is around 0-2 cm from the tumor margin, according to tumor size and location.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with hepatocellular carcinoma of BCLC stage A
* liver function Child-pugh A
* normal indocyanine green retention rate
* adequate liver remnant

Exclusion Criteria:

* age less than 17 y or older than 65 y
* unresectable liver cancer
* intraoperative ablation
* contraindication for liver resection
* preoperative treatment for hepatocellular
* active hepatitis
* pregnant
* multi-original tumors
* mixed liver cancer (hepatocellular carcinoma and cholangiocellular carcinoma)
* tumor recurrence
Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery

Patients undergoing Cesarean delivery (C-Section) with a body mass index of 35 or greater (this BMI number is in the obese range) will be given either 2 grams or 4 grams of an antibiotic before surgery. The antibiotic is intended to prevent infection from the surgery.It is unknown what the best dose for large women is for the usual medicine used for this purpose (an antibiotic medicine called cefazolin).Samples of the tissue just under the skin will be biopsied at the time the incision is made and at the time the cut is stitched or stapled closed. A sample of the muscle of the womb will be taken as the womb is stitched closed after the delivery. Blood tests will be done at the start and end of surgery to test the antibiotic level. A blood sample will be taken from the umbilical cord after the baby has been delivered and the umbilical cord has been cut. The umbilical cord blood sample will be tested for the antibiotic level.These tests will be used to find out if the usual dose of medicine is enough or if more medicine is needed to prevent infection in large women undergoing c-sections.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or above
2. Body mass index (BMI) of 35 or greater at the time of the first obstetric clinic visit
3. Undergoing cesarean delivery

Exclusion Criteria:

1. BMI less than 35.
2. Not undergoing Cesarean delivery.
3. Age less than 18 years.
4. Pre-existing infection.
5. Allergy to cephalosporin medications or a history of an anaphylactic reaction to penicillin.
6. Cesarean delivery being performed under emergent circumstances.
Trial of Latex Vs Non-latex Hemorrhoid Banding

This study will involve the recruitment of adult patients with hemorrhoids for whom rubber band ligation is the recommended treatment. Patients will be randomized to receive banding with a latex band or non-latex band. Our goal will be to measure the performance of latex bands vs non-latex bands.

This study will involve the recruitment of adult patients with symptomatic grade 2-3 internal hemorrhoids for whom rubber band ligation is the recommended treatment. Patients will be randomized to receive banding with a latex band or non-latex band. Our hypothesis is that non-latex hemorrhoidal bands are non-inferior to latex bands for the treatment of grade 2-3 internal hemorrhoids.

The secondary objective of the study is to compare banding-related adverse effects including pain, bleeding, and complications assessed both immediately and within 3 weeks following each hemorrhoidal banding.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic grade 2-3 internal hemorrhoids undergoing rubber band ligation

Exclusion Criteria:

* Previous hemorrhoidal banding within the past year
* Known latex allergy
* Pregnancy
* Anticoagulation use
* Bleeding disorder
* Portal hypertension
* Inflammatory bowel disease
* Immunosuppression
* Functional neurologic disorder
* Pelvic floor dysfunction
* Any records flagged "break the glass" or "research opt out".
Fibre-optic Guided Tracheal Intubation Through SADs

The study aims to establish which of the two second generation Supraglottic Airway Devices, the I-gel or the the laryngeal ask airway (LMA) Protector, is best suited to be used as a conduit to fibreoptic bronchoscope assisted tracheal intubation. The primary outcome of this will be the time to complete the tracheal intubation.

Tracheal intubation through a supraglottic airway device (SAD) is a well-established technique in the management of patients with a difficult airway. The technique can be used in patients in whom difficult intubation is expected, or in situations when tracheal intubation using another method was not possible. It is now recommended that tracheal intubation through the SAD should be performed using a fibreoptic scope (a camera device) to minimise the risk of trauma to the airway, and that second generation SADs are used to minimise the risk of aspiration of gastric contents.

There are two second generation SADs currently available which allow tracheal intubation: the I-gel and the LMA protector.

The I-gel is a second generation supraglottic airway device widely used in anaesthesia and resuscitation. Fibreoptic intubation through the I-gel has been evaluated in a recent prospective study (1), with the first attempt success rate of 91.4%. In another study (2) of patients with predicted difficult airway, the success rate of the procedure at first attempt was 96%.

LMA Protector is a recently introduced, improved version the LMA supreme - another second generation SAD. LMA supreme has been used in clinical practice for more than 10 years, however, tracheal intubation through the device was extremely difficult because of the small size of the breathing channel. The LMA Protector, has a larger breathing channel allowing the passage of an endotracheal tube. Compared to the I-gel, is has also got a larger gastric drainage tube. This allows easy suction in the event of regurgitation. Therefore, it appears to be superior to the I-gel in preventing the aspiration. But there are no studies comparing the ease of intubation through I-gel and LMA Protector

The aim of this study is to compare the ease of performing the fibreoptic guided tracheal intubation through these two devices. Our hypothesis is that intubation through the I-gel is easier and quicker.

Eligibility Criteria:
Inclusion Criteria:

• All patients aged above 18, presenting for elective surgical procedure, where a supraglottic airway device can be used and left in place throughout the duration of surgery and requiring tracheal intubation

Exclusion Criteria:

* Patients who are do not wish to take part
* Patients with class II obesity (BMI \>40)
* Patients below 18 years of age
* American Society of Anaesthesiologists (ASA 3, 4 and 5)
* Patients with mouth opening of less than 3 cm
* Patients deemed to require awake intubation
* Surgery involving head and neck region
* Surgery requiring prone position
Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis

The purpose of this study is to compare two variations of the mini-PCNL procedure using either a vacuum-assisted sheath or standard sheath which are both used for the surgical treatment of kidney stones. Both procedure types are commonly used in the treatment of kidneys stones and they have been shown to be safe and effective in the treatment of stones similar in size and location to your own.

In this study we aim to compare two variations of the miniaturized percutaneous nephrolithotomy (Mini-PCNL) procedure which are both used for the surgical treatment of kidney stones. This procedure involves accessing the kidney via a small temporary tract that is placed through the patient's back during surgery. Both procedure types are commonly used in the treatment of kidneys stones and they have been shown to be safe and effective in the treatment of stones similar in size and location to your own.

Two procedure types will be investigated:

1. Miniaturized percutaneous nephrolithotomy performed using a 16 Fr (6 mm diameter) vacuum-assisted tube with suction capability to assess the kidney and extract the stone.
2. Miniaturized percutaneous nephrolithotomy performed using a 16 Fr (6 mm diameter) standard tube to assess the kidney and extract the stone.

Approximately 90 people will take part in this study at Cleveland Clinic. The duration of the study will include the day of the surgery and following hospital stay until postoperative follow-up appointment with the surgeon approximately 4-6 weeks after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients with planned prone mini-PCNL and a preoperative NCCT
* Primary stone size: 10-25 mm
* Pre-existing indwelling nephrostomy tube or ureteral stent permitted
* Age: ≥ 18 years old
* Gender: all
* Ethnicity: all
* Capable of giving informed consent
* Capable and willing to fulfill requirements of the study

Exclusion Criteria:

* Anticoagulated or history of coagulopathy
* Congenital renal anomalies
* Prior ipsilateral upper urinary tract reconstructive procedures
* Conversion to open procedure
* Multiple access tracts
* Inability to give informed consent or unable to meet requirements of the study for any reason
Sintilimab Combined With Chemotherapy and Radiotherapy in Newly Diagnosed Metastatic Nasopharyngeal Carcinoma: A Multicenter Study

To explore the progression-free survival rate (progression-free survival, PFS), overall survival (OS), objective response rate(objective response rate, ORR) and safety of patients with Sintilimab + GP chemotherapy combined with radiotherapy for newly diagnosed metastatic NPC.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically diagnosed nasopharyngeal cancer with distant metastasis; not received anticancer treatment.
* ECOG Score (PS score) 0 or 1.
* Neutrophil count \> 1.5\*10\^9/L, hemoglobin \> 90g/L, and platelet count \> 100\*10\^9/L.
* ALT or AST level \< 2.5 times upper normal limit (upper limit of normal, ULN), bilirubin level \< 1.5 times ULN.
* Creatinine clearance level \> 60 ml/min.
* Patients must sign an informed consent and must be willing and able to comply with the visit, treatment protocol, laboratory tests and other requirements specified in the study protocol.
* Pregnant female subjects must agree to use reliable contraception within 1 year from the screening visit to the last Sintilimab administration.

Exclusion Criteria:

* Age\> 65 years old or \<18 years old.
* HBsAg positive and HBV DNA\> 10\*10\^3 copy number/ml.
* HCV antibody positive.
* Active, known, or suspected autoimmune diseases. Subjects with type I diabetes, hypothyroidism with only hormone replacement therapy, and skin disease without systemic treatment (such as vitiligo, psoriasis, or alopecia) can be selected.
* A history of interstitial lung disease.
* Received systemic hormone or other immunosuppressive therapy with an equivalent dose of\> 10mg of prednisone per day within 28 days prior to signing the informed consent. Subjects with a systemic hormone dose of 10mg prednisone per day or inhaled / topical corticosteroids may be enrolled.
* Received or will be vaccinated within 30 days before signing the informed consent.
* Pregnancy or breastfeeding women (pregnancy tests should be considered).
* Other malignancies within 5 years, except carcinoma in situ, fully treated non-melanoma skin cancer, and papillary thyroid carcinoma.
* previous allergies to macromolecular protein preparations, or any component of Sintilimab.
* Human immunodeficiency virus (HIV) infection.
* Other conditions that may affect the safety or trial compliance of the subject, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic treatment, mental illness or family and social factors.
Affinity: Hospital Trial

Method comparison study to compare the Affinity prototype device using a capillary blood sample against routine venous laboratory results, in patients undergoing systemic anti-cancer therapy (SACT). Tests will be performed by healthcare professionals (Cohort 1) and participants self-testing (Cohort 2)

In this study the Investigators wish to compare 200 finger prick sample (capillary) blood results taken and analysed using the Affinity prototype device to standard of care venous blood samples, taken from the participant on the same day. The blood tests will analyse Full Blood Count (FBC)

200 patients will be recruited in total. 100 will take part in Cohort 1, where a member of the clinical research team will take their blood sample using the Affinity prototype device. The other 100 will take part in Cohort 2, where the participant will self test and take the blood sample themselves. Participants will be asked to complete a short questionnaire after using the device to provide any feedback on its design and use.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old at the time of study entry Currently receiving standard of care systemic anti-cancer therapy for solid organ malignancy and has received at least one cycle
* Scheduled to be undergoing routine venous laboratory blood tests as part of standard of care
* Can provide written informed consent
* Cohort 2 only- Able to independently complete participant questionnaires

Exclusion Criteria:

* Receiving systemic anti-cancer therapy for a haematological malignancy
* Known parasitic infection
* Known inherited or acquired bleeding disorder
* History of haematological malignancy
* Known poorly controlled anti-coagulation
* Cohort 2 only- Participant or carer unable or unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result
Efficacy of Closed-loop Ventilation to Reduced Sleep Disorders

Sleep's deficiencies are very common in intensive care. Mechanical ventilation is a known factor in this deterioration.The investigators hypothesize that close-loop ventilation mode (Intellivent-ASV) is able to minimize sleep deterioration, adjusting ventilation to the patient needs.

In intensive care, conventional mechanical ventilation (pressure support) generates apneas and asynchronies during sleep. Intellivent-ASV would be able to avoid apneas, providing controlled cycles when respiratory rate become too low. Moreover, the constant adjustment of ventilatory parameters to the patient needs would avoid asynchronies between the ventilator and the patient ventilatory drive.

Eligibility Criteria:
Inclusion Criteria:

* patient under invasive mechanical ventilation since at least 6 hours and for expected at least 48 hours duration, including a continuous period of 24h, from 2 p.m. to 2 p.m. the next day.
* Age \> 18 years
* Body Mass Index \< 40
* informed consent signed by the family

Exclusion Criteria:

* patient requiring neuo-muscular blocking agent or deep sedation enough to abolish spontaneous ventilatory effort
* patient with encephalopathy regardless of origin
* Patient with Glasgow coma scale score \< 8
* Patient abusing of drug or alcohol
* patient with a contraindication for placement of a nasogastric tube such that sufferers of esophageal or gastric ulcer, tumors, diverticulitis or bleeding varices or patients with sinusitis epistaxis or having recently been operated on the nose or pharynx
* Patient with bleeding disorders
* Patient with unstable respiratory situation as defined by a arterial oxygen partial pressure and inspired oxygen fraction ratio (PaO2/FiO2) \< 100 mmHg with positive end expiratory pressure (PEEP) \> 12 cmH2O
* Patient with unstable hemodynamic situation as defined by Systolic Blood Pressure (SBP) \< 75 mmHg despite a therapeutic optimization
* Inclusion in another research protocol submitted to consent
Valopicitabine Alone and Together With Pegylated Interferon in Patients With Chronic Hepatitis C Who Have Failed to Respond to Standard Therapy

This study is being conducted to compare the safety, effectiveness and tolerance of valopicitabine (NM283) when used alone and when valopicitabine is used together with pegylated interferon in hepatitis C treatment failure patients. These results will be compared against the results of treatment with pegylated interferon plus ribavirin, the current standard therapy for treatment of hepatitis C viral infection.


Eligibility Criteria:
Inclusion Criteria:

* Documented clinical history compatible with chronic hepatitis C and compensated liver disease
* Failed response to previous hepatitis C therapy of pegylated interferon/ribavirin

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Patient is pregnant or breastfeeding
* Patient is co-infected with hepatitis B or HIV

Other protocol-defined exclusion criteria may apply.
Self-care Program in the Prevention of Admissions of Patients

One of the most cost effective intervention is to avoid unnecessary hospitalizations in the national health system. These unnecessary admissions are increasing for several years, reaching rates of over 30% in patients with chronic obstructive pulmonary disease (COPD) or heart failure at two months of hospital discharge. There is scientific evidence suggesting that a multidisciplinary intervention consisting in controling disease and stress associated with disease, and modifying eating habits could reduce the number of hospitalizations due to disease decompensation.

The main objective of the study is to assess the rate of readmissions at year of multidisciplinary intervention in patients with COPD and / or heart failure.

We will select 144 patients who will be randomized to two groups (control and intervention group) and they will be followed for 12 months through 4 visits (1 month, 3 months, 6 months and 12 months of hospital discharge).

Patients assigned to the intervention group will be receive three educational sessions (one of them will be imparted by nursing, another by the nutritionist and the last one by the psychologist). In addition, patients with a BMI \<20 and / or\> 30 will receive a closer monitoring by the nutritionist).

Patients assigned to the control group will receive usual care in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* COPD
* Heart failure: heart failure in clinically stable with ≥ II degree of NYHA . 1 or more emergency admissions for the same diagnosis in the prior year

Exclusion Criteria:

* Mental states that make difficult the self-care: Class 295, 296, 297, 298, 300, 301, 304 and 316 (schizophrenic disorders, episodic mood, delusional other nonorganic psychosis, anxiety, dissociative and somatoform, personality, alcohol and drug dependencies)
* Congenital respiratory diseases or presence of other obstructive pulmonary diseases
* Patients participating in other research studies.
* Other diseases that can affect patients' medium-term survival
* Moderate to severe cognitive impairment.
Sodium-Endothelial Function-CKD Study

Heart disease and stroke, known as cardiovascular disease, are major causes of death in people with chronic kidney disease. Abnormalities of a metabolic pathway called the "L-arginine-nitric oxide" pathway are thought to be particularly important in these people, and previous research in animals has suggested that sodium (salt) affects part of this metabolic pathway. The purpose of our research is to study the effects of sodium intake on the "L-arginine-nitric oxide" pathway, and on blood vessel function, in patients with kidney disease.

Chronic kidney disease (CKD) is associated with abnormalities of endothelial function (EF) and nitric oxide (NO) synthesis, and it is proposed that the endogenous NO synthase inhibitor asymmetrical dimethylarginine (ADMA) plays a central role. In man ADMA is largely metabolized by dimethylarginine dimethylaminohydrolase (DDAH), with some renal excretion occurring. Sodium inhibits DDAH expression in experimental animals and, given that CKD is frequently characterized by sodium retention, it would be interesting to study the effects of sodium loading on DDAH activity/expression, ADMA levels and EF in CKD patients.

To answer these questions, we have designed a double-blind cross-over study employing Slow Sodium (150 mmol/day) and placebo for seven days in individuals with mild-to-moderate CKD. Changes in the ratio of urinary ADMA to dimethylamine (DMA, an ADMA metabolite) will be used as an marker of DDAH activity/expression. ADMA will be measured by ELISA, DMA by high performance liquid chromatography, and EF by venous occlusion plethysmography.

We propose to test the following hypothesis; that in subjects with mild-to-moderate CKD under conditions of high sodium intake, as compared to low-normal sodium intake:

(i) The ratio \[ADMA\]urine:\[DMA\]urine is increased (ii) \[ADMA\]plasma is increased (iii) Endothelium-dependent vasodilatation is reduced

Eligibility Criteria:
Inclusion Criteria:

* CKD Stages 2 and 3 \[= calculated creatinine clearance of 30 to 89 ml/min/1.73m2 by Cockcroft-Gault formula\]
* 18 to 75 years old

Exclusion Criteria:

* \>3 g/24 hours of proteinuria
* Uncontrolled hypertension (systolic BP \>160 mmHg, diastolic BP \>100 mmHg on/off anti-hypertensive medication)
* Diabetes mellitus
* Tobacco smoking
* Total fasting cholesterol \>6 mmol/L
* Uncontrolled heart failure or active IHD
* Chronic liver failure
* Active malignancy
Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparoscopic Procedures

The purpose of this study is to evaluate the safety and feasibility of the Levita Dual Robotic Arm Accessory (DRAA) used with the Levita Magnetic Surgical System (MSS)

Prospective, multi-center, single-arm, open label study designed to assess the safety and feasibility of the use of the Dual Robotic Arm Accessory with the Levita Magnetic Surgical System in laparoscopic procedures

Eligibility Criteria:
Inclusion Criteria:

* • Subject is at least 18 years of age

  * Subject is scheduled to undergo elective laparoscopic procedure
  * Subject signs a written Informed Consent Form (ICF) to participate in the study prior to any study required procedures

Exclusion Criteria:

* • Subjects with pacemakers, defibrillators, or other electromedical implants

  * Subjects with ferromagnetic implants
  * Subjects with significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure)
  * Subjects with a clinical history of impaired coagulation confirmed by abnormal blood tests
  * Subject has an anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use
  * Subject is pregnant or wishes to become pregnant during the length of study participation
  * Subject is not likely to comply with the follow-up evaluation schedule
  * Subject is participating in a clinical trial of another investigational drug or device Prisoner or under incarceration