cyrilzakka/clinical-trials huggingface dataset:
Hepatic Safety of Raltegravir Versus Efavirenz as HIV Therapy for Patients With HIV and HCV Coinfection

The main objective is to evaluate the hepatic safety of raltegravir when compared to efavirenz, both in combination with tenofovir and emtricitabine as first-line HIV treatment in patients with HIV and hepatitis C coinfection.

The trial will recruit 80 treatment-naive HIV-infected patients with chronic hepatitis C coinfection from two HIV treatment centers in Vietnam. Patients will be randomized to receive either raltegravir or efavirenz, both in combination of tenofovir and emtricitabine, as first-line HIV therapy over a period of 72 weeks. The primary endpoint is the rate of alanine aminotransferase (ALT) elevation during the 72 week study period. Secondary endpoints include rates of virological suppression, CD4 count change, numbers of AIDS events and death, rates of fasting glucose and cholesterol measures, neurocognitive function and levels of immune activation. Patients will be followed monthly for the first 3 months and every 3 months thereafter. At the end of the trial period, patients will be transferred to the National HIV treatment program for continuation of HIV therapy.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected patients, age \>18 years, meet Vietnam guideline to begin ART (CD4 count \< 350 cells/mm3 and/or WHO stage III or IV disease)
* Hepatitis C infection as documented by positive HCV antibodies and a detectable serum HCV RNA level
* AST and ALT ≤ 2 x ULN (≤ 80 U/L)
* Estimated creatinine clearance ≥ 60 mL/min

Exclusion Criteria:

* Any prior ART
* Positive Hepatitis B surface antigen
* Clinical evidence of de-compensated cirrhosis (ascites, encephalopathy, esophageal bleeding)
* Requirement for acute therapy for other AIDS-defining illness within 14 days prior to study entry
* Currently on rifampicin therapy
* In the first trimester of pregnancy, intent to become pregnant, or breast feeding during the study period
Zaleplon in HIV Patients With Depression

In HIV positive patients with sleep onset insomnia and receiving pharmacologic treatment for comorbid depression, the proposed study aims to evaluate the impact of zaleplon on sleep measures determined by insomnia severity index (ISI) and Epworth sleepiness scale (ESS).

An estimated \>50% of HIV positive individuals report insomnia. Insomnia and other sleep disturbances negatively impact outcomes in this population by contributing to metabolic dysfunction, reducing quality of life, and impairing psychosocial functioning. Additionally, in HIV depressed populations, insomnia may hinder remission from clinical depression. To date, there have been no pharmacotherapeutic studies treating insomnia in this population, emphasizing the need to determine whether known hypnotic medications work as effectively in HIV positive patients, including those with comorbid depression. Non-benzodiazepine hypnotics represent an attractive pharmacotherapy for treatment of insomnia in a depressed population, as there are reduced side effects and abuse potential compared to classical benzodiazepines. Consequently, an open-label study evaluating zaleplon for insomnia in HIV positive patients with comorbid depression warrants further study.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged 18-65 years with a diagnosis of asymptomatic seropositive HIV
2. Principal diagnosis of Major Depressive Disorder or Dysthymic Disorder in accordance with DSM-IV criteria, and receiving pharmacologic treatment.
3. Subject has obtained some subjective benefit from current antidepressant therapy and is agreeable to remain on the same medication for the course of this study
4. Current symptoms of insomnia as determined by a total score of at least 2 on items 4, 5, and 6 of the HAM-D, and specific complaint of sleep onset insomnia (sleep onset latency of at least 1 hour, 3 or more times per week))
5. Free of sleep medication for at least 2 weeks prior to enrollment (we will not enroll any patients who might require weaning off of sedative hypnotic medications in order to be eligible for the study)
6. Ability to understand the requirements of the study and provide informed consent

Exclusion Criteria:

1. Significant chronic, systemic illness or significant neurologic disorder, including traumatic brain injury
2. Clinically significant history of liver disease
3. Psychiatrically unstable patients in the clinical judgment of the investigator as indicated by current acute suicidality, current homicidal thoughts, or current psychosis
4. Lifetime history of schizophrenia, schizoaffective disorder, or any psychotic illness
5. History of substance abuse or dependence over the past 6 months
6. Currently taking medication to assist with sleep (e.g., Ambien/Zolpidem,Dalmane/Flurazepam, Doral/Quazepam, Halcion/Triazolam, Lunesta/Eszopiclone, Prosom/Estazolam, Restoril/Temazepam, Rozerem/Ramelteon, Sonata/Zaleplon, Melatonin, Unisom, Benadryl).
7. Pregnant
Social Robot Support for Healthcare Professionals

This study evaluates the effectiveness of integrated care pathway steps supported by social robots. Half of the participants will receive regular care, while for the other half a social robot dialogue will be included as part of the pathway step.

There is a worldwide increasing shortage of adequately trained healthcare personnel, leading to the challenge for society to prevent a future "lack of care". At the same time the number of people requiring healthcare is expanding rapidly, amongst others due to the growing percentage of older adults in the population. New means of supporting the available healthcare professionals are therefore urgently required.

Modern healthcare is often implemented through "integrated care pathways". Certain steps in these pathways involve dialogues with patients. Speaking social robots are increasingly being advertised as supportive for healthcare professionals and may handle certain structured dialogue types, such as questionnaires. Based on previous positive preclinical experiences with social robots interviewing community-dwelling older subjects, the researchers want to investigate the implementation of a social robot in an integrated care pathway in the outpatient clinic.

Eligibility Criteria:
Inclusion Criteria:

* Suspicion of need for quality of life support

Exclusion Criteria:

* Psychiatric Disorders
A Study to Investigate the Bioequivalence of Two Different Forms of Entrectinib (Forms A and C) Under Fasted Conditions in Healthy Subjects

This study aims to demonstrate similarities between two different forms of entrectinib (A and C) when administered under fasted conditions in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy in the opinion of the investigator. Healthy is defined by the absence of evidence of any active disease or clinically significant medical condition based on a detailed medical history and examination
* Negative test results for Hepatitis B, Hepatitis C, and Human Immunodeficiency Virus (HIV)
* Females must not be pregnant or breastfeeding, and females of childbearing potential will agree to use highly-effective contraception. Females of childbearing potential must also agree to refrain from donating eggs during the treatment period and for 6 weeks after the final dose of study drug
* Males must agree to use contraception and to refrain from sperm donation from check-in (Day -1 of Period 1) to 90 days after the final dose of study drug

Exclusion Criteria:

* History of gastrointestinal surgery or other gastrointestinal disorder that might affect absorption of medicines from the gastrointestinal tract
* Presence of a clinically significant disease, illness, medical condition or disorder, or any other medical history determined by the investigator to be clinically significant and relevant. Ongoing chronic disorders which are not considered clinically significant are permissible providing they are stable
* Clinically significant change in health status, as judged by the investigator, or any major illness within the 4 weeks before screening, or clinically significant acute infection or febrile illness within the 14 days before screening
* Participation in any other clinical study involving an investigational medicinal product (IMP) or device within 30 days or 5 half-lives (if known), whichever is longer, before screening
Anesthesia, TIVA, Balanced Anesthesia, NK Cell

Anesthetic method was reported to have an impact on postoperative long-term outcome in cancer patients. In this study, we will investigate the effect of different anesthetic methods on NK cell activity, cytokine response and postoperative outcome in colorectal cancer patients undergoing CRS and HIPEC. We will compare propofol-based total intravenous anesthesia (TIVA) with balanced anesthesia to determine the effect of propofol, inhalation agent, and opioid on tumor genesis, recurrence, NK cell activity, cytokine response, and postoperative outcome.


Eligibility Criteria:
Inclusion Criteria:

1. Colorectal cancer patients undergoing elective cytoreductive surgery and HIPEC (20-70 yrs old)
2. American Society of Anesthesiologists physical status I, II, III

Exclusion Criteria:

1. Patients under 20 years old.
2. Patients with long-term steroid therapy or immunosuppressive therapy.
3. Patients with long-term NSAIDs therapy.
4. Patients who cannot communicate with other person or with cognitive disorder.
5. Patients who cannot read the consent form.
Pharmacodynamics, Safety and Pharmacokinetics After Oral Administration of BIBR 1048 MS in Healthy Volunteers

The objective of this study was to assess safety, pharmacokinetics and the effect of BIBR 953 ZW on coagulation parameters of BIBR 953 ZW after oral single doses of the prodrug, BIBR 1048 MS, in healthy male subjects. This was the first administration of this substance to humans.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
* Age \>= 18 and \<= 45 years
* Broca \>= - 20 % and \<= + 20 %

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or relevant acute infections
* History of

  * allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  * any bleeding disorder including prolonged or habitual bleeding
  * other hematologic disease
  * cerebral bleeding (e.g. after a car accident)
  * commotion cerebri
* Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
* Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within 2 months prior to administration or during trial
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation within 1 month prior to administration or during the trial
* Excessive physical activities within 5 days prior to administration or during the trial
* Any laboratory value outside the clinically accepted reference range
* History of any familial bleeding disorder
* Thrombocytes \< 150000/µl
Improving Locomotor Learning With Brain Stimulation

The primary goal of this research was to assess the practicality and initial effectiveness of a motor imagery (MI) intervention combined with elements of action observation (AO), alongside active or sham transcranial direct current stimulation (tDCS) over the prefrontal cortex (PFC), on locomotor learning in healthy adults. Feasibility was determined by examining recruitment rates, participant engagement, and safety measures. The efficacy of the intervention was gauged by analyzing the time taken to complete tasks and changes in cerebral blood flow immediately after the intervention and one week later. The study was guided by three main hypotheses: (1) the intervention techniques would be well-received and safe for the participants; (2) compared to a control group, MI training would lead to better learning outcomes and retention of learning; (3) in comparison to the control and sham tDCS groups, active tDCS would result in superior learning outcomes and retention of learning.

The study implemented a double-blind, randomized, controlled trial design. Participants were tested three times over 7 days. After study enrollment, the participants were randomly assigned to one of three groups: MIActive (receiving active tDCS stimulation and participating in MI protocol), MISham (receiving sham tDCS stimulation and participating in MI protocol), and Control (receiving no stimulation and participating in an unrelated video-watching task) by a research member not associated with data collection. Allocation ratio was 1:1:1 and a block randomization approach was employed to maintain an equal distribution of participants across the three groups throughout the study. Study participants and assessors were blinded to assignment of active or sham tDCS. The independent variables were time (pre, post, and retention trials) and group (MIActive, MISham and Control), and the dependent variables were time to completion of a complex obstacle course and the amount of change in oxygenated hemoglobin (ΔO2Hb) during performance of that task.

Eligibility Criteria:
Inclusion Criteria:

* Male and female adults age 18 and older
* Freely ambulatory (no assistive walking aids)

Exclusion Criteria:

* Failure to meet specific inclusion criteria
* History or presence of any neurological disease
* Low visual ability, operationally defined as visual acuity less than 20/70 on the standard eye chart
* Extreme difficulty performing walking tasks due to low visual ability
* Clinical judgment of the investigative team
* Additionally, subjects who are determined to be at increased risk for adverse events during the tDCS procedure, as determined by the tDCS screening questionnaire
Genetic Biomarkers in Tissue Samples From Patients With Osteosarcoma

This clinical trial studies genetic biomarkers in tissue samples from patients with osteosarcoma. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer

Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Samples from the COG Sampling Method: Non-Probability Sample

PRIMARY OBJECTIVES:

I. To use PET sequencing to analyze DNA from ten human primary osteosarcoma samples, along with matched normal tissue where available.

OUTLINE:

Tissue samples are analyzed for translocations and deletions and analyzed using polymerase chain reaction (PCR) or fluorescence in situ hybridization (FISH).

Eligibility Criteria:
Inclusion Criteria:

* Samples from the COG tissue repository
Avalanche Phenomenon During Airways Opening in Acute Respiratory Distress Syndrome

Acute respiratory distress syndrome accounts for 23% of mechanically ventilated patients and is associated with high mortality rate. Although life-saving, mechanical ventilation may worsen lung injury through two main mechanisms: lung overdistension and atelectrauma. Indeed, the cyclic opening and closure of airways during tidal ventilation may cause lung and bronchial injuries as suggested by animal models and autopsy findings. Complete airways closure has recently been described in 40% of patients with acute respiratory distress syndrome, and setting positive end-expiratory pressure above the airway opening pressure may limit atelectrauma. However, animal and mathematical models suggest that above the airway opening pressure, more distal airways open unevenly according to their own opening pressure, resulting in an "avalanche"-like phenomenon during lung inflation. This phenomenon has never been described in humans. A better understanding of the opening of airways in acute respiratory distress syndrome may help to limit ventilation-induced lung injury and to improve outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Moderate-to-severe acute respiratory distress syndrome within the first 72 hours after meeting the Berlin definition criteria:
* Within 1 week of a known clinical insult or new or worsening respiratory symptoms;
* Bilateral opacities (not fully explained by effusions, lobar/lung collapse, or nodules);
* Respiratory failure not fully explained by cardiac failure or fluid overload;
* PaO2/FiO2 ≤ 200 mmHg with positive end-expiratory pressure ≥ 5 cmH2O.
* Absence of spontaneous breathing efforts
* Consent to participate to the study from the patient and/or its surrogate

Exclusion Criteria:

* Pneumothorax
* Broncho-pleural fistula
* Tracheostomy
* Hemodynamic instability
* Severe hypoxemia
* Suspected of proven intracranial hypertension
* Chronic obstructive lung disease
* Pacemaker or defibrillator
* Decision to withhold of withdraw life-sustaining measures
* Under protection
Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants

The objective of this study is to assess the safety and immunogenicity of recombinant thrombin (rThrombin) administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric patients, newborn through 17 years of age.

The safety, immunogenicity, and efficacy of rThrombin have been evaluated in 5 Phase 2 studies, 1 pivotal Phase 3 study, and 1 Phase 3b study, in surgical indications such as: spinal surgery, major hepatic resection, peripheral arterial bypass surgery, arteriovenous graft formation for hemodialysis access, and burn wound excision. Limited data currently exist on the effects of rThrombin exposure in pediatric patients. This Phase 4 trial aims to provide additional information on the use of rThrombin in children by evaluating the drug's safety and immunogenicity when administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric burn patients.

Eligibility Criteria:
Inclusion Criteria:

* Age of newborn through 17 years at time of enrollment
* At least 1 skin graft recipient site measuring at least 1% of total body surface area (TBSA)
* Total initial burn wounds estimated to measure less than 40% of TBSA
* Bleeding indicating treatment with rThrombin during the surgical procedure
* Females of child-bearing potential must have a negative urine or serum pregnancy test within 2 days prior to study-drug treatment
* informed consent document signed by legal representative (guardian) and approved by an institutional review board/independent ethics committee (IRB/IEC)
* Participant has signed an IRB/IEC-approved pediatric assent document, if applicable

Exclusion Criteria:

* Gestational age younger than 36 weeks at birth (for infants younger than 2 years)
* Documented active infection at the graft recipient site (participants with resolved infections at potential graft recipient sites are not excluded)
* Acute inhalation injury, as defined by bronchoscopic evidence of lower airway injury
* Currently undergoing autologous skin grafting for ischemic ulcer disease or cutaneous malignancies
* Presence of antibodies or hypersensitivity to the study drug or any of its components, other thrombin preparations, or coagulation factors
* Transfusion of whole blood, fresh frozen plasma, cryoprecipitate, or platelets within 24 hours prior to study-drug treatment (packed red blood cell transfusions are allowed)
* History of HIV infection or other immunodeficiency syndrome or is taking immunosuppressive or antirejection medications
* Medical, social, or psychosocial factors that, in the opinion of the investigator, could affect safety or compliance with study procedures
* Breastfeeding or being breastfed
* Treatment with any experimental agent within 30 days of study enrollment or treatment
Different Stapler Cartridge For Pancreatic Stump Texture To Prevent Pancreatic Fistula

The purpose of this trial is to establish an objective criterion for assessing pancreatic stump texture, and unify stapler cartridge according to pancreatic stump texture and thickness.

Distal pancreatectomy (DP) is the standard treatment for symptomatic benign, premalignant, and malignant lesions in the pancreatic body and tail.Laparoscopic distal pancreatectomy (LDP) are reported to have lower blood loss, fewer postoperative complications and a shorter length of stay without a substantial increase in the operative time. Pancreatic fistula (PF) is the major source of postoperative morbidity and is associated with numerous further complications, suffering, longer hospital stay, higher costs and sometimes death. Frequencies range from 5% to 64%. Several procedures have been proposed to reduce the rate of PF. stapler closure is considered to be safe and approved particularly in LDP. Numerous predictive factors for PF have been reported in previous studies. Among these risk factors, the most important might be the texture and thickness of the remnant pancreas. However, the judgment of pancreatic texture has been based on the surgeon's observation and there still exists no objective method of assessing pancreatic texture. Furthermore there is no strict guideline on which type of cartridge to use according to pancreatic stump texture and thickness. Therefore, this single blind randomized controlled trial is designed to establish an objective criterion for assessing pancreatic stump texture, and unify stapler cartridge according to pancreatic stump texture and thickness. Patients were stratified intraoperatively by gland texture-hard (fibrotic) or soft (normal) and subsequently randomized according to different stapler cartridge. Pancreatic fibrosis is accessed by histopathology and pancreatic stellate cell.

Eligibility Criteria:
Inclusion Criteria:

1. disease of pancreatic body and tail
2. Age: 18 years or older
3. distant metastases are not diagnosed preoperatively.
4. Patients who can provide written informed consent

Exclusion Criteria:

1. Patients with severe organ disease such as cardiac disease,respiratory illness
2. Patients with pancreaticojejunostomy,pancreatogastrostomy
3. Patients with conversion to laparotomy
4. Patients with pregnancy