cyrilzakka/clinical-trials huggingface dataset:
The Predictive Value of Clinical Data on Perioperative and Postoperative Risk Events in Patients With Head and Neck Artery Stenosis

The Predictive Value of Clinical Data on Perioperative and Postoperative Risk Events in Patients With Head and Neck Artery Stenosis


Eligibility Criteria:
Inclusion Criteria:

* (1) All enrolled patients were diagnosed with clear head and neck artery stenosis and a risk event after head and neck revascularization;

  (2) Location of lesion: origin of internal carotid artery, bifurcation of internal and external carotid arteries;

  (3) Patients with symptomatic head and neck artery stenosis and dangerous events after head and neck blood flow reconstruction, and with a degree of stenosis ≥ 70% on non-invasive examination or stenosis ≥ 50% found on angiography;

  (4) Asymptomatic head and neck artery stenosis and risk events after head and neck revascularization, with a degree of stenosis ≥ 70% on non-invasive examination or stenosis ≥ 60% found on angiography;

  (5) Asymptomatic head and neck artery stenosis and dangerous events after head and neck blood flow reconstruction, with a non-invasive examination of stenosis degree less than 70%, but angiography or other examinations indicate that the stenosis lesion is in an unstable state;

  (6) Symptomatic head and neck artery stenosis and risk events after head and neck revascularization, non-invasive examination of head and neck artery stenosis and risk event degree after head and neck revascularization at 50% to 69%

Exclusion Criteria:

* (1) Patients with poor overall condition and intolerance to general anesthesia;

  (2) Patients with mental illness or severe mental illness;

  (3) Severe respiratory system diseases;

  (4) Pregnant and lactating women;

  (5) Participating in another clinical study;

  (6) Patients with advanced tumors or those who are expected to die within one year;
Water Immersion in Right-Sided Heart Failure: A Pilot Study

This is an unblinded pilot study comparing (against a randomized control day without water immersion) the diuretic and natriuretic effects of water immersion in patients with right heart failure.

Patients will be immersed in a tub for 3 hours (on one day) and neurohormones will be obtained before and after immersion. Urine will be collected for quantification and evaluation of sodium concentration.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have right sided failure secondary to right ventricular dysfunction, pulmonary hypertension, or tricuspid regurgitation
* Age greater than 18 years of age
* Right heart catheterization within the last year to rule out left-sided failure.
* Evidence of fluid overload as indicated by 2 or more of the following: 1.) 2+ or more pitting edema of the lower extremities, 2.) scrotal or penile edema, 3.) JVP greater than or equal to 10 cm, 4.) abdominal ascites

Exclusion Criteria:

* Pulmonary capillary wedge pressure above 16 mmHg or history of elevated left ventricular filling pressures.
* Serum creatinine \> 2.0
* Current use of an angiotensin I converting enzyme inhibitor or angiotensin receptor blocker will preclude participation in the RAS neurohormone portion of the study.
A New Prognostic Scoring System for Spontaneous Ruptured Hepatocellular

Develop a new scoring system for HCC patients with tumor rupture.

There has been no special prognostic scoring system for HCC patients with tumor rupture in the literature. In this work, we obtained all survival risk factors of ruptured HCC patients who underwent partial hepatectomy using multivariable Cox regression analysis. Furthermore, we develop and validate a new postoperative scoring system for patients with spontaneous HCC rupture based on the these results.

Eligibility Criteria:
Inclusion Criteria:

* Received partial hepatectomy; with Child A or B liver function.

Exclusion Criteria:

* Without complete data；loss of follow-up; had reveived repeated transcatheter arterial chemoembolization before rupture; received non-radical resection.
Pharmacokinetic Study for Anti-tuberculosis Drugs

The purpose of this study is to evaluate the effect of food on pharmacokinetic profile of multiple doses orally administered first-line anti-tuberculosis drugs in subjects with pulmonary tuberculosis.

This is a single-center, open-label, randomized, two way crossover design, pharmacokinetics study.

1. Treatment A: study agents (Rifater+EMB) will be given approximately 45 minutes prior to breakfast.
2. Treatment B: study agents (Rifater+EMB) will be given approximately 45 minutes after the breakfast is finished.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 20 years
2. Karnofsky score of \> 50
3. Clinical and radiographic signs and symptoms consistent with pulmonary TB determined by the investigator.
4. A documented positive microbiology diagnosis results which indicate highly suspected pulmonary tuberculosis.
5. Anti-TB drugs treatment with of ethambutol, isoniazid, rifampin and pyrazinamide.
6. Willing to be hospitalized per standard of care for at least 6 days from first does of anti-TB drugs administered.
7. Start anti-TB chemotherapy for at least 2 days prior to participate in the study.
8. The subject is able to understand and comply with protocol requirements, and follow the instructions and protocol-stated restrictions.
9. Only subjects who have provided signed and dated written informed consent will be included.

Exclusion Criteria:

1. Previously treated for MDR-TB, XDR-TB or likely to require surgical procedure for management of TB
2. Alcohol or drug abuse that would interfere with the ability to meet study requirements (in the opinion of investigator)
3. Concomitant disorders or conditions for which ethambutol, isoniazid, rifampin or pyrazinamide are contraindicated.
4. Unable to meet selected safety criteria obtained at screening (Laboratory parameters, etc.)
5. Women who are Pregnant or breastfeeding during the study period.
6. Subjects with a known allergy to study drugs
7. In the opinion of the investigator to be unsuitable for study participation for any reason.
Enhancing Thoracolumbar Burst Fracture Treatment

The optimal treatment for neurologically intact thoracolumbar fractures remains controversial. Percutaneous pedicle screw fixation (PPSF) has been proposed for these fractures; however, achieving satisfactory reduction can be challenging. This study applied robot-assisted PPSF to enhance treatment outcomes.

The optimal treatment for neurologically intact thoracolumbar fractures remains controversial. Percutaneous pedicle screw fixation (PPSF) has been proposed for these fractures; however, achieving satisfactory reduction can be challenging. This study applied robot-assisted PPSF to enhance treatment outcomes. The investigators retrospectively analyzed the medical records of 182 consecutive patients with thoracolumbar burst fractures treated with PPSF, with (n=88) and without (n=94) robotic assistance, at our hospital between April 2017 and June 2019. The participants were evaluated surgical time, intraoperative bleeding, radiation dosage, accuracy of screw placement, fractured vertebral height, Cobb's angle, surgery efficacy (pain relief and limb function), and implant failure to assess the potential advantages of robot-assisted PPSF. Robot-assisted PPSF for thoracolumbar burst fractures reduces surgery time and intraoperative bleeding, enhances screw placement accuracy, and achieves better reduction compared to the free-hand technique. This approach effectively prevents endplate collapse and recurrence of kyphosis post-surgery. However, functional recovery in the short term is similar between the two methods.

Eligibility Criteria:
Inclusion Criteria:

had thoracolumbar burst fractures classified as Magerl type A3 underwent short segment posterior fixation (SSPF) showed no signs of osteoporosis on dual-energy X-ray absorptiometry in patients older than 60 years.

Exclusion Criteria:

had fractures outside the T11-L2 range presented with old fractures, (iii) had a Parker score ≥ 7 had multiple segment fractures had neurological deficiency caused by fractures had concomitant pain caused by spinal degeneration such as lumbar disc protrusion, spondylolisthesis, spinal stenosis, and/or scoliosis could not receive pedicle screw placement due to bilateral pedicle fractures with displacement had incomplete clinical data or were lost to follow-up
Cardiac Output Changes During Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Cesarean Section

Spinal block leads to the reduction of systemic vascular resistance (SVR) which may effect the cardiac output. Ngan Kee et al. has showed that spina block with 0.5% hyperbaric bupivacaine for Cesarean section combined with intravenous infusion norepinephrine had higher cardiac output than those who received phenylephrine


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology classification I - II
* Elective or urgency Cesarean section with spinal block e.g. cephalopelvic disproportion, premature rupture of membrane
* Singleton pregnancy
* Body mass index \< 40 kg/m2

Exclusion Criteria:

* Pregnancy \<35 weeks gestational age
* Hypertensive disease e.g. gestational hypertension, chronic hypertension, preeclampsia
* History of allergy to the study drugs
The Relationship of Trunk Position Sense and Spinal Posture With Balance in Parkinson's

The 4 main motor symptoms seen in Parkinson's patients are tremor, rigidity, postural instability and bradykinesia. In addition to these, another common symptom investigators encounter is balance problems. Increasing balance problems can lead to falls and fractures over time, which will further reduce the independence of Parkinson's patients who are not already active enough and reduce their quality of life. For these reasons, it is very important that balance is achieved and sustainable. It has been found in previous studies that spinal posture and body position sensation are affected in Parkinson's patients. But to our knowledge, no study has been found in the literature to address the effect these have had on balance function. In our planned study, investigators aim to investigate the effects of spinal posture and body position sensation on balance function.

Resting tremor, muscular rigidity, bradykinesia (slowing of movements) and postural instability in Parkinson's patients constitute the 4 main motor symptoms of Parkinson's. In addition, he has been in various studies where posture is affected in Parkinson's disease and proprioceptive sensory loss is seen. These symptoms reduce the quality of life of patients and can also cause loss of balance. It is very important to maintain balance due to problems such as loss of balance in Parkinson's patients leading to falls and the resulting fractures. Determining the factors that may cause falls in Parkinson's patients is important because of its guidance in terms of preventive approaches and treatment options to be developed afterwards. In our research in literature, no study has been found in Parkinson's exploring the effects of spinal proprioceptive sensory loss and spinal posture on balance function. With this work planned accordingly:

(A) Loss of spinal proprioceptive sensation in Parkinson's, (B) Changes in spinal posture in Parkinson's and (C) It was intended to investigate the effects of spinal proprioceptive sensory loss and spinal postural changes on balance function in Parkinson's patients.

Eligibility Criteria:
Inclusion Criteria For Parkinson's patients:

* Being 18 years or older
* Receiving a diagnosis of Parkinson Disease made by a specialist neurologist
* Being able to walk independently
* Being between stages 1-4 on the Hoehn \& Yahr scale

Inclusion Criteria For Healthy Volunteers :

-Being 18 years or older

Exclusion Criteria For Parkinson's patients:

* Having any neurological disease other than Parkinson's
* Presence of cardiovascular, vestibular and musculoskeletal disease
* Having a score of \<24 on the Standardized Mini Mental Test

Exclusion Criteria For Healthy Volunteers :

* Having any disease that may affect balance, gait, posture and respiratory functions
* Using sedative - antidepressant medication that will impair physical well-being
* Having a score of \<24 on the Standardized Mini Mental Test
Clinical Study on Thymus-Kidney Transplantation From Neonatal Donors for the Induction of Immune Tolerance

Thymus transplantation for the induction of immune tolerance in kidney transplantation: This study aims to understand how thymus transplantation can induce immune tolerance in recipients of allogeneic kidney transplants to achieve the discontinuation of immunosuppressive therapy. It will evaluate the safety of thymus transplantation, explore the functional output of thymus tissue, investigate the optimal timing for withdrawal of immunosuppressants, and identify key indicators for the reconstruction of immune suppression capacity.


Eligibility Criteria:
Inclusion Criteria:

1. Recipients of both thymus and kidney transplants from the same donor.
2. Age between 18 and 65 years.
3. Non-solid organ combination transplant recipients (including heart-kidney or liver-kidney transplants, except thymus).
4. ABO blood type compatibility with the donor.
5. Negative donor-specific antibody (DSA).
6. Negative lymphocyte crossmatch (CDC).
7. Normal cardiac function (confirmed through ECG and echocardiograms).
8. Normal liver function.
9. Bodyweight between 40-100 kg (inclusive).
10. Evidence of prior epstein-barr virus (EBV) infection with positive EBV-specific immunoglobulin G (IgG) and negative immunoglobulin M (IgM).
11. Signed informed consent form.
12. Ability to adhere to regular follow-ups.
13. Normal hematopoietic function.

Exclusion Criteria:

1. Clinically significant genital or urinary tract dysfunction.
2. Underlying kidney diseases with a high risk of recurrence in the transplanted kidney, including:

   * a. Focal segmental glomerulosclerosis (FSGS).
   * b. Type I or II membranoproliferative glomerulonephritis.
   * c. Hemolytic uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP).
3. Any genetic mutation-associated diseases.
4. Presence of infectious diseases:
5. Strongly positive panel reactive antibodies (PRA).
6. History of receiving blood transfusion therapy.
7. Any other conditions that, in the investigator's opinion, are incompatible with participation in the trial.
Probiotic in Patients With Bile Acid Malabsorption/Diarrhea

The purpose of this study is to assess effect of the DSF probiotic on fecal bile acid levels in patients with BAM.

In this placebo-controlled trial, the De Simone combination probiotic formulation will be tested in 12 patients in each treatment arm. The patient's will be previously diagnosed with bile acid diarrhea. The objective is to assess the effects of this probiotic on fecal blood low acid levels in patients with bile acid diarrhea. Secondary objectives are to evaluate changes in% primary fecal bile acids in a single stool sample, serum 7 alpha C4, intestinal permeability, stool consistency and frequency, fecal short chain fatty acids, and fecal micro biome composition and diversity

Eligibility Criteria:
Inclusion criteria:

* Prior diagnosis of bile acid malabsorption documented in the medical history based on

  * either serum C4 \>52.5ng/mL, or
  * fecal 48h total BA excretion \>2337 μmol/48h, or
  * primary BA \>5% 48h stool collection or \>10% in single stool sample.
* 7-day stool dairy with an average stool consistency based on the Bristol Stool Form Scale, BSFS, with a grade greater than 5. Note: If Inclusion criteria 3 is not met, participants may choose to have their blood drawn clinically to further determine eligibility.
* For women of childbearing potential

  * A negative urine pregnancy test prior to dispensing the study product
  * Agreement to comply with approved methods of contraception during the whole study: unless they meet the criteria of post-menopausal, i.e. 12 months of spontaneous amenorrhea, women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner, should use one or more of the following acceptable methods of contraception that should be maintained throughout the study:

    * Surgical sterilization
    * Hormonal contraception (implantable, patch, oral, intra-muscular)
    * Intra-uterine device
    * Double barrier method (diaphragm plus condom)
    * At the discretion of the investigator, total abstinence is acceptable in cases where age, career, lifestyle, or sexual orientation of the patient ensures compliance

Exclusion criteria:

* Use of oral antibiotics and probiotics within the last 4 weeks.
* Pregnancy or lactation.
* Concomitant use of bile acid sequestrants, must stop 10 days before starting 7-day stool dairy and for the duration of the study.
* History of ileal resection.
* Diabetes mellitus (type 1)
* BMI ≥ 40 kg/m\^2
* Diagnosis of gastrointestinal diseases that are associated with inflammation such as inflammatory bowel diseases and celiac diseases or gastrointestinal infection in the prior 4 weeks
* Any condition or personal circumstance that, in the opinion of the investigator, renders the subject unlikely or unable to comply with the full study protocol or could interfere with the study assessments
Spinal Anesthesia for Robotic Assisted Laparoscopic Prostatectomy

We hypothesised that spinal anesthesia as an adjunct to general anesthesia would facilitate faster recovery and less pain in patients undergoing laparoscopic robotic prostatectomy. A double-blind placebo-controlled study was subsequently designed.

Patients were allocated to either intrathecal injection of bupivacaine/morphine or a sham spinal procedure. All patients were placed in a sitting position and the skin over the lumbar region of the back was disinfected with chlorhexidine and draped sterile. In the intervention group the skin was infiltrated with 5 mL of lidocaine 10 mg/mL and a sterile 27-gauge pencil-point needle (Pajunk, GA, USA) was subsequently entered into the intrathecal space at the L2-3 or L3-4 interspace. After obtaining return of cerebrospinal fluid, hyperbaric bupivacaine 5 mg/mL 1,5 mL (7,5 mg) and morphine 200 µg/mL, 0.5 mL (100 µg) was injected intrathecally. Patients in the placebo group received an identical treatment as the patients in the intervention group, except for the intrathecal injection. After the skin was infiltrated with 5 mL of lidocaine 10 mg/mL, the attending anesthesiologist pressed one finger at the skin and talked as if she was giving an intrathecal injection at the L3-4 interspace. All patients were treated by the same anesthesiologist (MA).

Eligibility Criteria:
Inclusion Criteria:

- Prostate cancer

Exclusion Criteria:

* Benign prostate disease
Near Normalisation of BG Improves the Potentiating Effect of GLP-1

The ability of glucagon-like peptide 1 to enhance beta-cell responsiveness to I.v. glucose is impaired in patients with type 2 diabetes mellitus compared with healthy individuals. We investigated whether 4 weeks of near-normalisation og blood glucose improves the potentiation of glucose-stimulated insulin secretion by GLP-1


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years
* Type 2 diabetes diagnosed after 30 years of age
* BMI \> 25

Exclusion Criteria:

* Severe complications to diabetes
* Abnormal liver og kidney function
* Haemoglobin below the lower limit
* Macroalbuminuria
* Systemic disease
* Pregnancy
Physio-Anatomy Clinical Data Collection Study

This is an on-label clinical study design intended for the collection of three different types of interventional procedural data using FDA-cleared cardiac catheterization technologies and drugs, each used according to its product labeling and standard practice of medicine.

These devices and drugs are commonly used for patient evaluation during PCI procedures performed by Interventional Cardiologists. The three device technologies used in a single catheterization laboratory visit for assessment of the coronary arteries include:

* A coronary angiography imaging system to X-ray the coronary arteries for the evaluation of vessel narrowing or blocking.
* Pressure guidewire from one or more manufacturers for the measurement of coronary physiology parameters.
* Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging catheter for imaging and sizing of the stenosed coronary arteries.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years of age.
* Patients provide written informed consent.
* Clinical presentation consistent with suspected coronary disease.
* Patients who are candidates for PCI and scheduled for coronary diagnostics in the cardiac catheter lab with the intent to perform a physiological assessment for de novo lesions with stenosis, if clinically indicated.

Exclusion Criteria:

* Presence of acute ST Elevation Myocardial Infarction (STEMI) at the time of the cath lab procedure.
* Contraindication for FFR examination or administration of vasodilators.
* Bacteremia or sepsis.
* Major coagulation system abnormalities.
* Severe hemodynamic instability or shock.
* Heart Failure NYHA Class IV.
* Severe valvular heart disease.
* Prior heart transplant.
* Acute renal failure based on diagnostic practice of the treating physician at time of screening.
* Patient is pregnant.
* Patient is currently enrolled in another clinical study that may impact the results of this study.
* Patient has other co-morbid condition(s) that, in the opinion of the Investigator, could limit their
Metabolic Changes Induced by Genetically Modified Potatoes

Starches from genetically modified potatoes, which differed in terms of amylose, amylopectin and phosphate content, were tested in a human randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* healthy males

Exclusion Criteria:

* no acute oder severe chronic diseases
A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.

This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic kidney disease, not requiring dialysis;
* receiving darbepoetin alfa maintenance therapy for \>=8 weeks before screening, and during screening/baseline period.

Exclusion Criteria:

* overt gastrointestinal bleeding within 8 weeks before screening, or during screening/baseline period;
* transfusion of red blood cells within 8 weeks before screening, or during screening/baseline period;
* active malignant disease;
* previous treatment with Mircera.
Weight Loss Prior Mamma Reduction - A Pilot Study

Due to a higher risk of complications, obese and overweight patients with macromastia are in Denmark prohibited mammoplasty , as BMI must be within normal range, i.e. BMI \< 25 kg/m2.

The study is a pilot study with a diet intervention group and no control group. The intervention is a 12 week low energy diet pre-operative weight loss program investigating if this will result in weight loss making the overweight and obese patients eligible for breast reduction surgery i.e. BMI \< 25.


Eligibility Criteria:
Inclusion Criteria:

* entitled to mammoplasty,
* motivated towards participation in a weight loss program
* BMI within the range 25.5 to 35 kg/m2

Exclusion Criteria:

* more than 65 years of age
* insulin-dependent diabetes
* chronic heart, liver or kidney failure