cyrilzakka/clinical-trials huggingface dataset:
Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition

This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy of standard nutrition treatment versus conventional nutrition treatment in local advanced nasopharyngeal carcinoma patients.


Eligibility Criteria:
Inclusion Criteria:

* Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III);
* All genders，range from 18～65 years old;
* Karnofsky performance status(KPS) ≥ 80;
* Clinical stage III\~IVa(AJCC/UICC 8th);
* Without significant digestive system disease，nutritional and metabolic diseases or endocrine disease
* Without significant cardiac，respiratory，kidney or liver disease;
* Not received radiotherapy, chemotherapy and other anti-tumor treatment(including immunotherapy);
* White blood cell(WBC) count ≥ 4×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, Hemoglobin(HGB) ≥ 9g/L, platelet(PLT) count ≥ 100×109/L
* Total bilirubin(TBIL)、alanine aminotransferase (ALT) or aspartate aminotransferase(AST) \< 2.5×upper limit of normal(ULN);
* Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
* No contraindications to chemotherapy or radiotherapy;
* Inform consent form;

Exclusion Criteria:

* Have some PEG/PEJ contraindications, such as coagulopathy, recent anticoagulant medications and aspirin, gastric ulcer or history of gastric bleeding, portal hypertension combined with abdominal and esophageal fundal varices, pyloric obstruction due to residual stomach under the costal arch after various major gastrectomy or various reasons;
* Distance metastases;
* Have or are suffering from other malignant tumors;
* Participating in other clinical trials;
* Drug or alcohol addition;
* Do not have full capacity for civil acts;
* Mental disorder;
* Pregnancy or lactation;
* Severe complication, eg, uncontrolled hypertension;
Evaluating the Need for Pneumatic Compression Devices

For patients undergoing total hip and knee arthroplasty, does the use of Aspirin alone compared to using Aspirin along with a mobile compression device provide equivocal results for preventing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE) after total joint arthroplasty? The investigator will evaluate the prevention of DVT/PE after total hip and knee arthroplasty will be evaluated to see if there is a decreased risk of bleeding while continuing to prevent thromboembolic disease. The equivalency of using the mobile compression devices with aspirin compared to aspirin alone in patients undergoing total hip and knee arthroplasty will be evaluated. A previous study has shown that patient compliance with the pneumatic compression device is less than 80%.

The research question is: does the use of Aspirin alone compared to using Aspirin along with a mobile compression device provide equivocal results for preventing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE) after total joint arthroplasty? Participants were randomized to either receive aspirin and mobile pneumatic compression devices or aspirin alone as outpatient DVT prophylaxis as their standard of care after primary total hip and total knee arthroplasty. Participants randomized to the compression device group were asked to wear the compression devices for 20 hours a day for 2 weeks along with taking an aspirin (325mg once a day), per standard of care. Participants randomized to aspirin alone took 325 mg per day. Participant usage information from Active Care +S.F.T. mobile devices was collected. The information was recorded at the participant's first follow up visit occurring between 7-21 days post-surgery. All of the participants were asked to keep a checklist indicating aspirin intake compliance each day, which was returned at their first follow up visit. Participants randomized to mobile pneumatic compression device and aspirin (325 mg) were asked to complete a satisfaction questionnaire about the compression device at their first follow up visit. Participants received a phone call from a member of the research team approximately 90 days post-op. The call was necessary to assess if any participants have been diagnosed with DVT at another hospital.

Eligibility Criteria:
Inclusion Criteria:

1. All patients, 18+ years of age, scheduled at WVU Medicine Center for Joint Replacement for a History and Physical visit to undergo a total hip or knee surgery.
2. Primary replacements and revisions.
3. Weight bearing as tolerated postoperatively.

Exclusion Criteria:

1. History of DVT/PE
2. History of hypercoagulable disorder
3. Currently on other blood thinning medication with the exception of aspirin (Plavix, Coumadin, xarelto, pradaxa, lovenox, heparin, other Factor Xa inhibitors).
4. Patients less than 18 years of age.
Dietary Supplement With and Without a Probiotic

Complex oligosaccharides can alter the gut microbiome by aiding in the growth of certain organisms, and possibly, inhibiting others. The synergy with a probiotic may enhance gastrointestinal colonization.

The study will evaluate the synergy of the use of a complex oligosaccharide with and without a probiotic on the human microbiome in healthy volunteers. The combination should support general gastrointestinal health.

The study a multi-dose randomized cohort trial using 10 subjects per cohort for a total of 60 healthy adult volunteers ages 18-44.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults between the ages of 18-44 years
* Willingness to complete all study procedures and clinic visits, and provide required samples
* Provides informed consent

Exclusion Criteria:

* Women who are pregnant or breastfeeding, or intend to become pregnant during the course of this study
* Subjects with history of lactose intolerance
* Subjects who are on a PPI regimen
* Subjects who have taken a probiotic during the previous 30 days, or intends to take a probiotic during the study.
* Subjects who have taken antibiotics within 120 days
* Alcohol or drug abuse during the last 12 months, including passing a screen for drugs of abuse at screening
* Unstable medical condition, in the opinion of the investigator
* Clinically significant abnormal laboratory test results at screening
* Participation in a clinical research trial within 30 days prior to screening
* Unable to give informed consent
* Any condition which may preclude subject's ability to comply with and complete the study or may pose a risk to the health of the subject
Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in HIV Infected Patients

Highly active antiretroviral therapy (HAART) has improved the long time survival of HIV infected individuals. However an increasing number of HIV-patients have developed metabolic and morphological alterations including peripheral lipoatrophy.

There is limited knowledge about lipodystrophic adverse events in nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimens. The hypothesis is that nucleoside analogues are responsible for development of lipoatrophy, and, patients receiving an NRTI-sparing regimen will have little risk of peripheral lipoatrophy.

The researchers plan to perform a randomized study recruiting 100 antiretroviral naive patients that will be randomized to receive a nucleoside analogue sparing HAART regimen or a protease-inhibitor sparing regimen.

The main endpoint is changes in peripheral fat mass as determined by dual energy X-ray absortiometry (DEXA)-scanning.


Eligibility Criteria:
Inclusion Criteria:

* Antiretroviral naïve patients
* HIV-1 infection as documented by a licensed HIV-1 antibody ELISA.
* Fulfilling the criteria for starting antiretroviral therapy.
* Ability to understand and provide written informed consent.

Exclusion Criteria:

* Women being pregnant or breast-feeding.
* Fertile women using no safe contraception.
* Patients with active intravenous drug use.
* Abuse of alcohol, which in the opinion of the treating physician will reduce the patient´s ability to follow a therapeutic regimen and evaluations of the protocol.
* Ongoing medical treatment, which has a clinically significant interaction with lopinavir, ritonavir or efavirenz.
* Creatinine \> 200 mmol/l.
* ALT or AST \> 5 times upper normal value (200U/l).
Three Dose Regimen of Tranexamic Acid in Cardiac Surgery

Tranexamic acid is thought to be a promising substitute for aprotinin when the latter has seceded in 2007. Yet the ideal dosage and dosing regimen of tranexamic acid in cardiopulmonary bypass cardiac surgery in Chinese population remains controversial. The current study includes patients receiving valvular replacement and coronary artery bypass surgery. Three dosage regimen of tranexamic acid is delivered and blood loss, transfusions and clinical outcomes are recorded.


Eligibility Criteria:
Inclusion Criteria:

* Rheumatic or recessive valvular disease patients requiring valvular replacement surgery with cardiopulmonary bypass
* Coronary artery disease patients requiring coronary artery bypass surgery with cardiopulmonary bypass
* Wrriten consent obtained

Exclusion Criteria:

* Non-primary cardiac surgery
* Preoperative liver or renal dysfunction
* Preoperative coagulation disorder
* Allergy
* Pregnancy or lactation
* Disabled in spirit or law
* Fatal conditions such as tumour
7-day Compared With 10-day Antibiotic Treatment for Febrile Urinary Tract Infections in Children

The investigators aim to assess the effectiveness of a 7-day compared with a 10-day course of antibiotic treatment for febrile urinary tract infections (UTIs) in children. It is formulated a hypothesis that a 7-day course of antibiotic therapy is equally effective as a 10-day course of therapy and would entail a lower risk of adverse events and better compliance.

In previously published European and global guidelines, there has been no consensus among experts regarding the duration of therapy for a febrile UTI. Depending on the recommendation, the duration of treatment should be between 7-14 days.

221 patients aged 3 months to 7 years with febrile UTIs (defined as a combination of fever and leukocyturia in urine sediment) will be randomly assigned to receive a 7-day treatment arm (7 days of cefuroxime/cefuroxime axetil followed by 3 days of blinded placebo) or a 10-day treatment arm (7 days of cefuroxime/cefuroxime axetil followed by 3 days of blinded cefuroxime axetil).

The primary outcome measure will be frequencies of recurrence and reinfection of UTI during the 6 months after the intervention. The secondary outcome measures will be antibiotic-associated diarrhea and compliance.

Eligibility Criteria:
Inclusion Criteria (must have all):

* children aged from 3 months to 7 years
* clinical diagnosis of a febrile UTI at presentation according to urinalysis (white blood cells in the sediment \>10 in the field of view);
* fever ≥38°C
* positive urine collection with sensitivity for cefuroxime
* treatment cefuroxime or cefuroxime axetil for 7 days

Exclusion Criteria (must have one):

* history of a UTI in the last 3 months
* prophylaxis for UTI
* antibiotic therapy in the last month
* known allergy to the study drugs
* immunosuppression therapy
* disease with immune deficiency
* children with other coexisting infection, e.g. meningitis, sepsis, pneumonia, otitis
* severe obstructive uropathy
Internet-delivered Emotion Regulation Individual Therapy or Adolescents (IERITA) with Self-injury Within Child and Adolescent Mental Health Services: Pilot Study

The overall purpose of the study is to implement and evaluate IERITA (Internet-delivered Emotion Regulation Individual Therapy for Adolescents) within child and adolescent mental health services for adolescents engaging in nonsuicidal self-injury (NSSI) and to optimize treatment outcomes for those adolescents at risk of insufficient effects. The specific purpose of this pilot trial is to investigate feasibility in preparation for a larger trial.

Self-injury without the intention to die is a growing and urgent global health crisis among youth. It is associated with substantial individual and societal costs, including increased risk of suicide attempts. Scalable and evidence-based treatments are needed but lacking. Digital interventions can be one promising solution. A recent study shows that a novel brief digital treatment, IERITA, can be efficacious compared to treatment as usual only. However, not all respond sufficiently to standardized treatment, such as IERITA, and continued self-injury entails risks and suffering.

In this randomized controlled pilot trial, participants will be randomly allocated (1:1) to standard IERITA or adaptable IERITA. All participants will first receive standard IERITA for four weeks. In treatment week four, non-remission will be predicted. Adolescents allocated to adaptable IERITA and classified as likely non-remission, will change to adapted IERITA for the remaining eight weeks while all other participants will continue standard IERITA. Data will be collected pre-treatment, during treatment, post-treatment, one- three- and twelve-month post-treatment. The primary endpoint is one-month post-treatment.

The main objective is to investigate the project's feasibility and test key components. The specific objectives are:

1. Examine the feasibility of the project (treatment satisfaction and adherence, degree of participation in data collection, and level of resources).
2. Explore the utility of adapted IERITA compared to standard IERITA for adolescents at risk of non-remission.
3. Evaluate the performance of the algorithm predicting treatment non-remission.

This project is sponsored by the Swedish Research Council for Health, Working life, and Welfare (number 2024-01916)

Eligibility Criteria:
Inclusion Criteria:

* 13-17 years old
* At least one self-injury episode in the past three months
* A parent willing to engage in the parent program

Exclusion Criteria:

* Immediate suicide risk
* Global functioning corresponding to a rating ≤40 of the Children's Global Assessment Scale (CGAS)
* Social problems needing immediate intervention (e.g., violence within the family)
* Ongoing dialectical behavior therapy for adolescents
Comparison of Two Different Video Laryngoscopes

The aim of this study is to answer the question of whether direct laryngoscopy can be performed with videolaryngoscopes. How do the videos of the laryngoscopes provide images directly in laryngoscopy? Primary objective: To compare the images of Hugemed and Mcgrath videolarinygoscope in direct laryngoscopy and indirect laryngoscopy secondary objective: to compare the effects on haemodynamic response Participants :people who are not expected to have difficult intubation

Direct and indirect images of hugemed and McGrath videolaryngoscope during intubation, haemodynamic responses, procedure time will be compared

Eligibility Criteria:
Inclusion Criteria:

To be between 18 -65 years old Mallampati score I-II Cormack-Lehane score I-II ASA physical status I-II who required endotracheal intubation for elective surgery

Exclusion criteria Pregnancy Mallampati score III-IV Cormack-Lehane score III-IV ASA physical score III-IV sternomental distance \< 12.5 cm mandibular-hyoid distance \< 6 cm
A Study to Determine the Maintenance of Effect After Long-term Treatment of Sativex® in Subjects With Neuropathic Pain

The purpose of this study is to assess the maintenance of effect after long-term treatment of Sativex® in subjects with neuropathic pain.

A five week randomised-withdrawal phase (Part B) for a subset of subjects who took part in a 38 week, multicentre, open label (Part A) follow-on study to evaluate, the maintenance of effect of, the development of tolerance through exposure to, and safety of, Sativex® in the treatment of subjects with neuropathic pain. Subjects returned to the centre for an end of treatment visit at week 38 of Part A (Visit 5, Day 266), followed by Visits 5b (week 39), 5c (week 43) and an end of study visit took place 28 days after Visit 5c or withdrawal from the study.

Eligibility Criteria:
Inclusion Criteria:

* Had participated in GWCL0404, was currently ongoing in the study (i.e. still receiving GW-1000-02 treatment) and had completed the study up to Visit 5
* Had complied with all of the study requirements to-date, including the completion of the diary cards
* Had shown tolerability to the study medication in this study
* Ability (in the investigators opinion) and willingness to comply with all study requirements, including the completion of diary cards and study questionnaires

Exclusion Criteria:

* Had experienced or was currently experiencing any adverse events or untoward medical occurrences which, in the opinion of the investigator, would prevent them from safely participating in this phase of the study
Pharmacokinetics of Oxytocin at Cesarean Delivery

The primary objective is to obtain data to inform the design of a population pharmacokinetic study of oxytocin after administration at CD as per standard institutional practice.

In this pilot study the investigators will compare plasma oxytocin concentrations measured in arterial and venous blood, after oxytocin administration at cesarean delivery, in order to assess the validity of venous samples. They will also measure oxytocinase to explore how levels vary around the time of delivery of the placenta and to assess the effect that this may have on the metabolism of oxytocin.

Eligibility Criteria:
Inclusion Criteria:

* Term singleton pregnancy
* Age 18-45 years of age
* ASA classification 2 or 3
* Scheduled cesarean delivery under neuraxial anaesthesia

Exclusion Criteria:

* Age or ASA classification outside of inclusion criteria
* Need for general anaesthesia
* Absence of consent
* Inability to communicate in English or other barrier to providing informed consent
A Study to Evaluate the Safety, Tolerability and Efficacy of Multiple Doses of JS002 in Patients With Hyperlipidemia..

JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent.
2. Age ≥18 and ≤65 years old;
3. Body mass index (BMI) ≥18 and ≤ 30 kg/m2;
4. Subjects who are receiving statin therapy at the time of screening or who are eligible for statin therapy can receive a stable dose of statin therapy for more than 28 days before randomization and are willing to maintain stable statin therapy during the study;
5. Low-density lipoprotein cholesterol (LDL-C) level ≥2.6mmol/L for subjects who are receiving statin and/or other lipid-lowering therapy at the time of screening, or LDL-C≥ 4.1mmol/L for subjects who didn't receive any-lowering therapy at the time of screening, and LDL-C still ≥2.6mmol/L before randomization;
6. Fasting triglycerides ≤4.5 mmol/L;

Exclusion Criteria:

1. Diagnosis of homozygous familial hypercholesterolemia;
2. History of New York heart association (NYHA) defined Ⅱ - Ⅳ heart failure;
3. History of uncontrolled arrhythmiast;
4. History of myocardial infarction, history of PTCA or PCI or CABG, history of unstable angina befor 90 days of randomization;
5. History of stroke or TIA；
6. Uncontrolled hypertension with SBP≥160mmHg and/or DBP≥100mmHg
7. Type 1 diabetes, or type 2 diabetes that is or poorly controlled（HbA1c\> 8.0%);
Efficacy and Safety of Lumen Apposing Metal Stents

Endoscopic ultrasonography (EUS) has revolutioned the management of gastroenterological patients and is acquiring an increasingly important role.

The development of specifically designed stents has significantly increased the technical and clinical success rate of the EUS-guided procedures, considerably reducing the rate of adverse events. Currently EUS has a prominent role in drainage of peripancreatic fluid collections and it represents an important therapeutic option for patients with distal malignant biliary obstruction, in which the ERCP fails, allowing the positioning of a transgastric or transbulbar lumen apposing metal stent (LAMS) to drain the biliary duct. Moreover, the EUS-guided gallbladder drainage of patients with high surgical risk and acute cholecystitis, which cannot be operated, is another important therapeutic indication.

Our aim is to perform a multicentre retrospective analysis of all types of EUS drainage (gallbladder drainage, biliary drainage, peripancreatic fluid collection drainage) with the positioning of LAMS in order to evaluate the rate of technical and clinical success and to assess the safety profile of these procedures.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Patients with distal malignant common bile duct obstruction with failed ERCP
* Patients with symptomatic peripancreatic fluid collections
* Patients with acute cholecystitis who are unfit for surgery
* Agree to receive follow up phone calls
* Able to provide written informed consent

Exclusion Criteria:

* Coagulation and/or platelets hereditary disorders.
* Pregnant women
* Inability to sign the informed consent
Diagnosing Obstructive Lung Disease With Point of Care Ultrasound

The objective of this study is to evaluate the diagnostic accuracy of Point of Care Ultrasound (POCUS) in identifying obstructive lung diseases (OLDs), using pulmonary function tests (PFTs) as the gold standard for comparison.

In this cross-sectional diagnostic accuracy test, 200 patients meeting the inclusion criteria will be enrolled to undergo random POCUS scans at the respiratory institute of Soroka University Medical Center. These patients, referred for PFTs, will be provided with a sonographic score based on several criteria. The study aims to capture comprehensive data, including sonographic results and medical history, to assess the sensitivity, specificity, PPV, and NPV of POCUS in diagnosing OLDs. Data management and analysis will be the responsibility of the Soroka Clinical Research Center, ensuring rigorous oversight and reliable results.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or above
* Referral for full pulmonary function tests (PFTs)
* Patients are willing and able to sign a written informed consent form.

Exclusion Criteria:

* Unable to give written informed consent.
* Unable to remain supine.
* Poor effort at PFTs
* Subcutaneous emphysema
Study of Weekly DCF to Treat Advanced Gastric Cancer

The purpose of this study is to evaluate the efficacy of weekly docetaxol combined with cisplatin and 5-Fu in patients with AGC.

Recently,in a multi-center, open-label randomized phase III study (V325), compared to the control arm of CF regimen, DCF showed higher efficacy in terms of response rate, time to progression and overall survival. But the regimen had increased grade 3-4 neutropenia (82% vs 57%) and febrile neutropenia infection (29% vs 12%). We began to study on weekly DCF in the patients with advanced gastric cancer to evaluate the efficacy no less than that of 3-week' regimen.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years
* Patients with histologically confirmed, unresectable, recurrent and/or metastatic gastric adenocarcinoma
* ECOG performance status ≤1,life expectancy more than 3 months,
* Normal laboratory findings:absolute neutrophil count and platelet count ≥ 2.0×109/L and 80×109/L, respectively, hepatic function (total serum bilirubin ≤ UNL, transaminases ≤ 1.5 times upper normal limit) and renal function (calculated creatinine clearance ≥ 60 ml/min).
* Measurable disease according to the RECIST.

Exclusion Criteria:

* Pregnant or lactating women
* Serious uncontrolled diseases and intercurrent infection
* The evidence of CNS metastasis
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Received other chemotherapy regimen after metastasis
* Used taxane in adjuvant settings
* Participated in other clinical trials.