cyrilzakka/clinical-trials huggingface dataset:
Recombinant Human Endostatin(Rh-endostatin) Combine With Radiotherapy in the Treatment of Hepatocellular Carcinoma(HCC)

Hepatocellular carcinoma(HCC) is a high malignancy cancer which progress rapidly , and the rates of morbidity and mortality is very high in China. Radiotherapy as a effective treatment is commonly used in unresectable HCC patients. Preclinical models have shown that anti-angiogenesis medicine,such as rh-endostatin, can normalize the tumor vasculature to make it more efficient for oxygen delivery, which can enhance the radiosensitivity subsequently. This study is to evaluate the safety and efficacy of rh-endostatin combined with radiotherapy in the treatment of HCC.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed hepatocellular carcinoma,or radiographic indicative HCC with AFP\>250ug/l
* Inoperable and untransplantable,Child-pugh score A or B
* PS score 0-1
* At least one measurable site(diameter \>20mm measured by CT or MRI,\>10mm measured by helical CT scan.
* No distant metastases
* Life expectancy longer than 3 months
* Willingness and ability to comply the study and signed informed consent.

Exclusion Criteria:

* Not comply the designed treatment or change to other treatment
* Miss follow-up visits or have incomplete follow-up data
* The efficacy will not be assessed if the Patient withdrawal the treatment due to severe adverse events(SAE),but SAE will be recorded.
* Disease progression
* Patients request to withdraw
* Patients with III hematologic or Ⅳ nonhematologic drug related toxicity ,or SAE
Phase IIB Pilot of Atazanavir + Raltegravir

The purpose of this study is to determine if the combination of atazanavir and raltegravir taken together is safe and effective in the treatment of human immunodeficiency virus (HIV).


Eligibility Criteria:
Inclusion Criteria:

* Human Immunodeficiency Virus (HIV)-1 positive status
* HIV ribonucleic acid (RNA) level \>=5000 copies/mL
* Antiretroviral treatment-naive
* Absolute Cluster of Differentiation 4 (CD4) cell count meeting 1 of the following criteria:
* \<350 cells/mm\^3
* Screening CD4 \>=350 and \<=500 cells/mm\^3 ONLY if at least 1 of the following conditions apply:

  * Screening HIV RNA level \>100,000 copies/mL, or
  * CD4 decline \>50-100 cells/mm\^3/year, or
  * Age \>=55 years
* Any CD4 cell count, if participant has a history of an acquired immune deficiency syndrome-defining illness
* Medically stable

Exclusion Criteria:

* Screening HIV genotype showing resistance to any component of the study regimen (Atazanavir, Raltegravir, Tenofovir/Emtricitabine)
* Hepatitis B or hepatitis C coinfection
* History of or current cardiac disease
* Electrocardiogram findings:
* PR Interval \>260 msec (severe 1st degree atrioventricular block)
* QRS Interval \>120 msec
Comparison of Insulin Detemir Plus Insulin Aspart With Insulin NPH Plus Human Soluble Insulin in Subjects With Type 1 Diabetes

This trial is conducted in Europe and South America. The aim of this trial is to compare the glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes for at least 12 months
* Current treatment with any basal/bolus regimen or any biphasic insulin treatment for at least 6 months
* BMI below or equal to 35 kg/m\^2
* HbA1c below or equal to 12%

Exclusion Criteria:

* Proliferative retinopathy or maculopathy requiring acute treatment
* Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the Investigator)
* Subjects with known hypoglycaemic unawareness as judged by the Investigator
Study to Evaluate the Effects of NMRA-323511 Among Healthy Elderly and Adults With Agitation Associated With Dementia Due to Alzheimer's Disease

This study consists of 2 parts, Part A and Part B. Part A is a single center, randomized, double-blind, placebo-controlled cohort designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of NMRA-323511 among healthy elderly.

Part B is a multicenter, randomized, double-blinded, placebo-controlled, parallel-group cohort to evaluate the safety, tolerability, and efficacy of NMRA-323511 among adults with Agitation Associated with Dementia due to Alzheimer's Disease.

Part A consists of a Screening Period (up to 28 days), a 10-day Treatment Period, and a 10- day Follow-up clinic visit after last dose of study treatment.

Part B consists of a Screening Period (up to 28 days), an 8-week Treatment Period, and a 10-day Follow-up clinic visit after last dose of study treatment.


Eligibility Criteria:
Inclusion Criteria:

Part A

* Healthy participants
* Age 65 to 80 years
* Body mass index (BMI) ≥18.0 and ≤32.0 kg/m\^2 at the screening and check-in visit

Part B

* Participants aged 55 to 90 years
* Diagnosis of probable AD or Alzheimer's clinical syndrome according to the National Institute of Aging-Alzheimer's Association criteria at least 12 months prior to screening
* Agitation meets the International Psychogeriatric Association (IPA) consensus definition
* Mini-Mental State Examination (MMSE) score = 5 - 24 (mild to severe dementia) at screening

Exclusion Criteria:

Part A

* Participant is actively suicidal
* Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit
* Diagnosis of epilepsy taking anticonvulsants for seizure control, history of seizures

Part B

* Dementia or memory impairment due to a reason other than AD
* Clinically significant neurologic disorder other than AD
* Have any clinically significant and uncontrolled medical condition

Note: Other protocol defined inclusion/exclusion criteria may apply
Effect of Enhanced Recovery After Surgery for Benign Anorectal Conditions

This study aims to assess the role of Enhanced recovery after surgery(ERAS) protocol in reducing postoperative urine retention (POUR) after surgery for benign anorectal conditions.

This study aims to assess the role of Enhanced recovery after surgery(ERAS) protocol in reducing postoperative urine retention (POUR) after surgery for benign anorectal conditions.

Patients of both sexes aged between 18 and 90 years old presented; with benign anorectal conditions including chronic anal fissure, hemorrhoids, and fistula-in-ano will be eligible for the study.

Eligible patients will be randomized in equal proportions to RRAS or ROUTINE pathways. The ERAS pathway was developed based on the available guidelines and protocols it includes 14 items.

Patients allocated to ERAS pathway must fulfill all the 14 items. The ROUTINE pathway will represent the routine practice which may include certain ERAS items or those who will not fulfill the 14 items.

For the end points of the study, all patients will be followed-up by a phone call 72 hours postoperatively then in the outpatients' department for a period of a total of 30 days postoperatively. However, patients will be advised to visit the outpatients' department at any other time during the trial if they developed any unfavorable event.

The primary outcome will be the 72-hours postoperative urinary retention after anorectal surgery.

Eligibility Criteria:
Inclusion Criteria:

* both sexes
* aged between 18 and 65 years old
* presented with benign anorectal conditions including chronic anal fissure, hemorrhoids, and fistula-in-ano will be eligible for the study

Exclusion Criteria:

* younger than 18
* older than 65 years old
* pregnant female
* history of relevant urological diagnosis (benign prostatic hyperplasia/prostate cancer/urethral stricture/bladder neck stenosis/detrusor underactivity/detrusor overactivity)
* history of relevant urological procedure (radical prostatectomy/ transurethral prostatectomy/bladder neck or urethral surgery/pelvic radiotherapy)
* use of permanent urinary catheter
* intraoperative urological procedures
* with any form of urinary diversion
* severe cognitive impairment
* who undergo other anorectal procedures
A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017)

Researchers are looking for ways to treat a type of liver disease caused by elevated liver fat, called metabolic dysfunction-associated steatohepatitis (MASH). MASH was formerly called non-alcoholic steatohepatitis (NASH). Researchers want to learn if a study medicine called efinopegdutide can treat MASH.The goals of this study are to learn:

* If efinopegdutide can lower the amount of fat, inflammation, and scarring (fibrosis) in the liver
* About the safety of efinopegdutide and how well people tolerate it


Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH)
* Has either type 2 diabetes that is controlled by diet or medication, or does not have type 2 diabetes

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has history of a liver disease other than MASH, for example, Hepatitis B or C, drug-induced liver disease, or autoimmune liver disease
* Has history of type 1 diabetes
* Had a bariatric surgical procedure less than 5 years before entry into the study
* History of pancreatitis
* Major illnesses like recent (within 6 months of study entry) episodes of heart problems, such as congestive heart failure, unstable angina, heart attack, stroke, or mini-stroke
Midurethral Synthetic Tape With Tension Control Mechanism Versus Midurethral Free Tape

This is a prospective, comparative randomized controled trial. The general purposes of this study is to compare the efficacy and safety of midurethral synthetic tape with tension control mechanism and conventional midurethral tension free tape as surgical treatment for female urinary stress incontinence.


Eligibility Criteria:
Inclusion Criteria:

Women suffering from stress urinary incontinence, mixed urinary incontinence with prevalence stress urinary incontinence

Exclusion Criteria:

* Pregnancy
* Women with neurogenic bladder dysfunction
* Recurrent stress urinary incontinence
* Woman with history of pelvic surgery
* Mixed urinary incontinence with prevalence urgency urinary incontinence
* Women who suffer from advanced POP (POP-Quantification system (POP-Q) stage more than 2)
* Women with acute urinary tract infection
* Women with bladder outlet obstruction
* Women who are not able to give informed consent or participate with this randomized research study for any other reason
dCell Vascular Patch in Peripheral Vascular Surgery Study for CE Mark Submission

The study is designed to produce early safety and performance data in a small group of patients requiring repair of a peripheral vascular endarterectomy (incision into an artery feeding the limbs which requires a patch to repair the incision after removal of an atherosclerotic plaque that was stopping usual blood flow to the limbs).

Data is being collected to show the procedure is safe and allows for normal blood flow to be resumed.

Data will be used to facilitate CE Mark submission.


Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled for a remote or open peripheral vascular endarterectomy
2. Lack of suitable autologous material to function as closure patch for the arteriotomy
3. Uncomplicated standard elective endarterectomy procedure (per-operative inclusion criteria)
4. Use of dCell™ Vascular Patch as arteriotomy closure material (per-operative inclusion criteria)
5. Patients between 18 and 80 years old, inclusive
6. Haemoglobin \> 9 g/dL and platelet count \> 100,000/mm3 prior to Day 1
7. Other haematological and biochemical parameters within a range acceptable for the administration of general anesthesia prior to Day 1
8. Ability to communicate meaningfully with investigative staff, competence to give written informed consent, and ability to comply with entire study procedures
9. Duly executed, written, informed consent obtained from patient

Exclusion Criteria:

1. Known serious allergy to contrast agent used for angiography
2. Treatment with any investigational drug or device within 60 days prior to study entry (Day 1)
3. If female and of child-bearing potential: evidence of a positive pregnancy test or a stated intention to become pregnant in the next 6-12 months
4. Patients receiving a revision of an existing graft
5. Patients demonstrating an active local or systemic infection (WBC \> 15,000/mm3)
6. Any condition which in the judgment of the Investigator would preclude adequate evaluation of dCell™ Vascular Patch's safety and performance
7. Patients on vitamin K antagonists
Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism

Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery. In this study, researchers affiliated with the University of Pennsylvania will test how well a radioactive drug (called F-DOPA) can detect a form of hyperinsulinism that may be cured by surgery. Eligible participants in this study will have positron emission tomography (PET) scans with F-DOPA prior to surgery.

For children with congenital hyperinsulinism (CHI), low blood sugar is caused by cells in the pancreas that release too much insulin. Some children with CHI have these cells throughout their pancreas; others have them located in specific areas of the pancreas. Children who have them located in specific areas of the pancreas may be cured with surgery. F-DOPA is a radioactive drug that may go to these very cells. F-DOPA can also be used for positron emission tomography (or PET), an imaging technique used in nuclear medicine departments. In this study, researchers will test the possibility of using PET with F-DOPA in the diagnosis of children with hyperinsulinism.

Eligibility Criteria:
Inclusion Criteria:

* Any age, but primarily infants 0-6 months.
* Children with confirmed diagnosis of congenital hyperinsulinism.

Exclusion Criteria:

* Cases in which surgery will not be considered by parents or guardians.
Advancing the Science of Pediatric Interstage Home Monitoring

The overall goal of this study is to understand the feasibility of using a wireless sensor device (instead of a wired device) to collect information used to monitor children with heart conditions at home.

The goal of this study is to examine how well continuous sensor-based monitoring performs at detecting physiologic data in infants with single ventricle physiology at home compared to existing approaches, in manner that is feasible and acceptable to patients' families. Performance features of interest include how the data compares to family measurements, whether it correlates with parents' observable symptoms, and how this approach may be integrated into home life and health system workflows. The investigators will also explore whether the collected data can be used to develop predictive analytics for acute deterioration and/or advanced chronic cardiopulmonary management compared to what is currently being done in remote patient monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Receiving active remote patient monitoring (RPM) in Lurie's Tele-Interstage Home Monitoring Program.
* Age 0-2 years of age at enrollment.
* In the opinion of the investigator, parent or legally authorized guardian, and participant, the participant and (when relevant) family can follow study procedures.

Exclusion Criteria:

* Is going to discontinue RPM before their enrollment would end (i.e., within 14 days).
* Skin breakdown or severe rash at the site of sensor placement.
* Patient without a parental guardian to consent.
* The patient is in active hospice or similar end-of-life care.
* The patient will be living in a long-term institution or transitional facility.
The Sunrise SpO2 and Pulse Rate Accuracy Validation Study

The purpose of this study is to evaluate the SpO2 accuracy performance of the Sunrise Sensor 2 placed at the tip of the chin during non-motion conditions over the range of 70-100% by comparison to SaO2 values determined from arterial blood sample specimen analyzed by a CO-oximeter. Testing is conducted under normal office environment conditions. It is expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system will meet the required specification of ARMS of 3.5% or less allowed for reflectance technology in non-motion conditions for the range of 70-100% SaO2.

A secondary goal is to evaluate the pulse rate performance simultaneously collected over the SpO2 range covered.

Subjects will be given medical grade mixtures of oxygen and nitrogen to induce stable plateaus across the range of 100% to 70% SaO2. When the reference system's blood saturation stabilizes at an acceptable plateau level, blood sampling can start. Four to eight arterial blood samples will be collected for each plateau, while keeping at least 20 seconds in between each sample and at least 30 seconds once the plateau has been reached. The blood will be immediately analyzed by the reference CO-Oximeter to measure the arterial oxygen saturation (Functional SaO2). SpO2 values from the Sunrise sensor 2 will be collected electronically simultaneously to blood drawn from the indwelling catheter. Data will be collected under non-motion conditions. The pulse rate will be simultaneously collected over the SpO2 range covered. The reference method for the computation of pulse rate accuracy will be an ECG heart rate. The total duration of the test will be about 1 hour per subject. Data analysis results will provide documentation showing SpO2 and pulse rate accuracy performance of the Sunrise sensor 2 as compared to arterial blood samples measured by Reference CO-Oximetry and to ECG heart rate, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with positive Allen's test
* Subject must be willing and able to comply with study procedures and duration
* Subject is a non-smoker or who has not smoked within 2 days prior to the study
* 15% of the study population or 2 subjects (whichever is larger) with dark pigmented skin should be included in the study

Exclusion Criteria:

* Subject is considered as being morbidly obese (defined as BMI \>39.5)
* Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study
* Subjects with known heart or cardiovascular conditions
* Subjects with other known health condition (diabetes, thyroid disease, kidney disease/chronic renal impairment, history of seizures (except childhood febrile seizures) or epilepsy, or unexplained syncope, recent history of frequent migraine headaches, recent head injury, cancer/chemotherapy)
Comparison of Rocuronium and Org 25969 With Cisatracurium and Neostigmine (19.4.310)(P05931)

The purpose of this study was to demonstrate in adult patients a faster recovery from a neuromuscular block with 2.0 mg/kg Org 25969 (sugammadex) after rocuronium as compared to 50 ug/kg neostigmine after cisatracurium when administered at reappearance of T2


Eligibility Criteria:
Inclusion Criteria:

* Subjects of ASA 1 - 4;
* Subjects above or equal to the age of 18;
* Scheduled for surgical procedures with a general anesthesia requiring neuromuscular relaxation with the use of rocuronium or cisatracurium;
* Scheduled for surgical procedures in supine position;
* Given written informed consent.

Exclusion Criteria:

* Subjects in whom a difficult intubation because of anatomical malformations was expected;
* Subjects known or suspected to have neuromuscular disorders impairing neuromuscular block (NMB) and/or significant renal dysfunction;
* Subjects known or suspected to have a (family) history of malignant hyperthermia;
* Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
* Subjects receiving medication in a dose and/or at a time point known to interfere with neuromuscular blocking agents such as antibiotics, anticonvulsants and Mg2+;
* Subjects in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
* Subjects who had already participated in an Org25969 trial;
* Subjects who had participated in another clinical trial (not pre-approved by NV Organon) within 30 days of entering into CT 19.4.310.
* Female subjects who are pregnant:
* Female subjects of childbearing potential not using any method of birth control: condom or using only hormonal contraception as birth control;
* Female subjects who were breast -feeding.
Diffusion Tensor (DTI) for the Assessement of Therapeutic Evolution of Patients With Acute Lumbar Radiculalgia

Diffusion tensor imaging (DTI) is a non-invasive MRI technique offering a functional approach that provides morphological information about the microstructures of the nerve roots. DTI is a widely used neuroimaging technique and is a current topic of research in the field of peripheral nerve imaging.The aim of the study is to determine the prognostic quality of the DTI parameters to predict the therapeutic evolution of patients with lumbar radiculalgia at 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 ans
* Patient with Lumbar Radiculalgia (L4, L5 or S1)
* Pain VAS (Visual analog scale) \> 30/100
* Less than 3 months of evolution
* With a radiculalgia superior or equal to lumbalgia
* Disco radicular conflict, verified by MRI
* Able to receive information
* Affiliated to French social security

Exclusion Criteria:

* History of chronic lumbalgia and radiculalgia
* History of lumbar surgery
* Recent episode (less than 6 months) with the same radicular topography
* Bilateral radicular compression on MRI
* Patient requiring emergency surgery
* Evolutive disease interfering with pain assesment (neoplasia, inflammatory rheumatism, peripheral neuropathy, central neurological disease)
* MRI contraindication
Health Mindset as a Driver of Efficacy of a Diabetes Prevention Program in the Blackfeet Community

The overall goal of this project is to understand whether the established Diabetes prevention program works to reduce diabetes risk by shifting mindsets about health.

The Diabetes Prevention Program (DPP), a lifestyle intervention which aims to modify health behaviors, has reduced diabetes risk across several American Indian Communities. However, there were significant attrition rates, and non-completers were at the highest risk at baseline. One's mindset about health (i.e. whether it is fixed or malleable) may affect their likelihood of completing the intervention and its efficacy in reducing risk. With an existing CAB, I will develop a culturally congruent adaptation of the DPP, the Mindset-DPP (M-DPP). The M-DPP will include a discussion of mindset in each session and will present material focused on the plasticity of health, including evidence that one's mindset can affect outcomes that relate to risk for diabetes. The investigators will implement the DPP and the MDPP in a sample of 40 Blackfeet community members at risk for diabetes and test whether the M-DPP associates with greater shifts towards a growth health mindsets (i.e. health can be changed by effort) compared to the DPP, and whether the M-DPP associates with greater increases in physical activity levels and greater reductions in waist circumference, and greater retention compared to the standard DPP.

Eligibility Criteria:
Inclusion Criteria:

* self identified as American Indian
* identified as high risk for diabetes based on the American Diabetes Association paper and pencil test
* must reside on the Blackfeet reservation

Exclusion Criteria:

-chronic disease diagnosis