cyrilzakka/clinical-trials huggingface dataset:
Vinorelbine in Treating Patients With Metastatic Prostate Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating patients with metastatic prostate cancer that has not responded to hormone therapy.

OBJECTIVES: I. Evaluate the efficacy of vinorelbine in patients with metastatic hormone-resistant prostate cancer. II. Evaluate the toxicity of vinorelbine in these patients. III. Evaluate the quality of life of these patients, and correlate quality of life with PSA response.

OUTLINE: Patients receive a 5-10 minute intravenous infusion of vinorelbine on day 1 and day 8 of a 21-day course. Patients with stabilization of their disease, partial response, or complete response, receive a maximum of 12 courses of treatment. Patients showing disease progression or severe toxic side effects discontinue treatment. Quality of life and pain are assessed prior to treatment, at days 1 and 8 of each course, and at end of the treatment. Patients are followed every 3 months until disease progression.

PROJECTED ACCRUAL: A total of 14-40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically proven metastatic stage IV prostate cancer Proven hormonal resistance Measurable or evaluable disease PSA at least 3 times upper limit of normal No leptomeningeal or brain metastases

PATIENT CHARACTERISTICS: Age: 18 to 85 Performance status: WHO 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: WBC at least 3500/mm3 OR Granulocyte count at least 2000/mm3 Hemoglobin at least 9 g/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: No acute severe infections No other neoplastic diseases except curatively treated basal cell or squamous cell carcinoma of the skin, or relapse free for more than 5 years after curative treatment of a neoplasm

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytostatic chemotherapy Endocrine therapy: At least 1 month since antiandrogens Prior hormonal therapy required Radiotherapy: No radiotherapy within the past 4 weeks No radiotherapy to the lesions used to evaluate activity of the study drug Surgery: Prior orchiectomy allowed Other: No other investigational drugs during the last month No prior therapy with cytostatic agents
Listening Effort in Tinnitus Patients

About 5-15% of the general population experience a chronic ringing, buzzing, hissing or roaring sound in one or two ears, without any external source. This so-called tinnitus can be present in people with normal hearing, but often coexists with hearing loss. Most people suffering from tinnitus can cope with it, however a minority experiences emotional distress or cognitive dysfunction as a result of the tinnitus, called tinnitus disorder. People suffering from tinnitus disorder regularly complain about an increased experienced effort when listening to speech or other sounds in daily life situations. As this has never been proven scientifically, the investigators aim to evaluate the effect of the tinnitus percept and tinnitus disorder on experienced listening effort by comparing listening effort between a population with tinnitus disorder and a population without tinnitus.


Eligibility Criteria:
Inclusion Criteria:

* Young adults, i.e. 18-69 year old;
* Pure tone average \<35 dB HL (0.5, 1, 2, 4 kHz);
* Proficient and native speaker of Dutch language;
* TINNITUS GROUP: Severe unilateral or bilateral tinnitus disorder (TQ \> 46).
* CONTROL GROUP: No tinnitus.

Exclusion Criteria:

* Significant asymmetric hearing loss: \|PTAright - PTAleft\| \> 15 dB (PTA = pure tone average of 500, 1000, 2000 and 4000 Hz);
* Significant loss of vision (text on screen at 70 cm should be readable);
* Frequent user of any of the following devices: Hearing Aid, Bone Conduction Device, Cochlear Implant, Tinnitus Masker;
* Additional mental or physical disabilities that may prevent active participation and testing as per protocol.
Impact of Nutrition Intervention on HIV/AIDS Infected Patients

Intervention to investigate the efficacy of a nutritional supplement among ARV-naïve, asymptomatic HIV positive patients with a CD4 count in the range 300-550 cells/ul.

To investigate the efficacy of a nutritional supplement among ARV-naïve, asymptomatic HIV positive patients with a CD4 count in the range 300-550 cells/ul.

A total of 120 participants will be stratified by age and gender and randomly assigned to two treatment arms. Sixty (60) participants will be assigned to receive dietary counselling and a multivitamin/mineral supplement, with sixty (60) additionally receiving an oral Medical Nutritional Supplement (MNS).

Participants will be followed for six months post-randomization: at baseline, 3 months and 6 months. The principal outcome measure is Body Mass Index, used as a proxy for 'nutritional status'. Secondary outcome measures include immune status and antioxidant status.

Eligibility Criteria:
Inclusion Criteria:

* HIV positive individuals in the age range 18 to 50 years.
* Individuals whose CD4 count was between 300-550 cells/uL.
* Individuals who met the study criteria and were interested in being enrolled.
* Individuals not on ARV therapy.
* Women who were not pregnant.

Exclusion Criteria:

* On the clinician's advice, individuals could be excluded from enrollment.
* Individuals who were unable to carry out the study intervention e.g. homeless, impaired mental state etc.
* Individuals who were unlikely to complete follow-up based on pre-enrolment assessment.
Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients

The objective of this study is to conduct an observational pre/post study to evaluate the clinical impact oxygen guideline implementation on oxygen utilization and oxygenation in critically ill trauma patients.

Supplemental oxygen is fundamental in caring for critically ill trauma. While the avoidance of hypoxia is vital, the current clinical practice of excessive oxygenation settings is common, and unnecessary, and may even be harmful.

An expert panel convened to define optimal oxygenation targets in critically ill trauma patients. The strong consensus was to target normoxia at an oxygen saturation (SpO2) range of 90-96% and arterial oxygen (PaO2) range of 60-100 mmHg. Accordingly, a pilot trial implementation of this consensus will occur for the care of trauma patients.

Specific Aim:

This is an observational pre/post study to evaluate the impact of targeted normoxia implementation in optimizing oxygen delivery and oxygenation in critically ill trauma patients.

Hypotheses:

That the clinical efforts to improve adherence to oxygen guidelines will:

1. improve the proportion of time spent with target normoxia thresholds (oxygen saturation SpO2 90-96%) by
2. reducing utilization of unnecessary supplementation oxygen
3. without a substantive increase in hypoxic episodes or an adverse impact on clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Acute Injury/Trauma
* Arrival to Emergency Department

Exclusion Criteria:

* \<18 years of age
* Known prisoners
Study of the Use of the Drug Ingaron in Patients With COVID-19

Interferon gamma is a powerful endogenous regulatory cytokine that activates the antiviral immune response, while it also has its own antiviral activity. The objective of this study was to evaluate the effectiveness of the proposed treatment regimen with Ingaron (INN: recombinant interferon gamma human, lyophilisate for preparing a solution for intramuscular and subcutaneous administration of 500,000 IU) in patients with viral pneumonia.

The study drug was prescribed for therapeutic purposes according to the following scheme:

500,000 IU s / c 1 time per day daily for 5 days. A total of 4 visits were scheduled. Visits 0 and 1 could be combined provided that the chronological sequence of screening and randomization procedures was followed.

The main stages of the study:

screening - lasting no more than 1 day; treatment - within 10-14 days, including the use of the investigational medicinal product for 5 days (from the first day of the basic therapy, daily).

The total duration of observation is up to 14 days. Patients who completed participation in the study or dropped out of the study ahead of schedule were followed up by the attending physician in accordance with the rules for managing such patients for a medical institution.

Eligibility Criteria:
Inclusion Criteria:

* Patients with viral pneumonia according to CT scan, regardless of:

  * degree of damage to the lungs;
  * results of a laboratory test for the presence of SARS-CoV-2 RNA;
  * epidemiological history.
* Patients of both sexes over 18 years of age.
* Patients who are able to read, understand and independently certify in writing the informed consent form.
* Negative pregnancy test for female patients of reproductive age with preserved reproductive function.

Exclusion Criteria:

* Any clinically confirmed or documented history of disease that may make it difficult to interpret the data being assessed.
* No symptoms of a respiratory infection.
* Severe liver or kidney failure, and/or failure of other vital organs, in the stage of decompensation (kidney - creatinine level\> 2X ULN, liver tests: liver enzymes (AST and ALT) \> 3X ULN).
* Diseases of the central nervous system with severe impairment of intellectual and mnestic functions.
* Any other disease or condition that, in the opinion of the investigator, may confound the results of the study, limit the patient's participation in the study, or place the patient at greater risk.
* Serious diseases and pathological conditions (PE, oncological diseases, etc.) that require emergency medical care or threaten the patient's life.
* Mild, subclinical, asymptomatic or severe form of the course of the disease.
* Acute respiratory distress syndrome, sepsis, septic shock.
* Contraindications to the use of the investigational medicinal product.
* Individual intolerance to the ingredients that make up the study drug.
* Participation in any clinical trial within 1 month prior to baseline visit (Day 0-1).
* Pregnancy or breastfeeding.
Opiate Sparing Protocol Randomized Controlled Trial in Open Distal Radius Fracture Repair

A comparison of oral morphine equivalents between an opiate sparing cohort and an opiate based cohort following open reduction internal fixation of a distal radius fracture.

Recently, the opioid epidemic has been the center of focus for healthcare providers and governmental agencies due to rising rates of opioid abuse, opioid-related fatalities, and overall economic burden of treating the opioid epidemic. The prescribing patterns of opioid pain medications have fallen under scrutiny and healthcare providers have sought alternative pain management strategies that have limited opioid pain medication use. As orthopaedic surgeons account for 7.7% of all dispensed opioid prescriptions within the United States, surgeons have investigated multimodal pain management strategies to assess effectiveness in controlling postoperative pain as well as limiting opioid use and opioid related complications. The literature documents the safety and effectiveness of non-steroid anti-inflammatory drugs (NSAID) and acetaminophen in soft tissue hand procedures and distal radius fracture plating. Currently, there remains no clear consensus on the ideal pain management strategy following open reduction internal fixation (ORIF) of distal radius fractures and the vast majority of strategies are based on opiate-driven protocols. This study will investigate the effectiveness of an opiate sparing protocol following open reduction and internal fixation (ORIF) of distal radius fractures on opiate consumption as measured by oral morphine equivalents at the 2, 6 and 12 week postoperative time point through collection of pill counts. Secondary outcomes are pain scores, patient satisfaction, and safety reporting (complications, reoperations, and readmissions) during the 12-week episode-of-care. This study will document the safety and effectiveness of an opiate sparing, multimodal pain management protocol in properly selected patients undergoing ORIF of distal radius fractures.

Following written consent documentation, Subjects will be randomized to either the opiate sparing cohort or the opiate based cohort at a 1:1 randomization. No blinding will occur as part of the study.

Eligibility Criteria:
Inclusion Criteria:

* Open reduction internal fixation surgery at Campbell Clinic Surgery Center
* Body Mass Index less than or equal to 45
* Fluent in verbal and written English

Exclusion Criteria:

* Known sensitivity to medications in either protocol
* Renal disease by medical history
* Concomitant ipsilateral upper extremity injury or condition other than wrist
* Chronic pain syndrome
* Consumption of ten consecutive day so opioid use in the previous 90 days
* Worker's compensation
* Women who are pregnant, planning to become pregnant, or are breastfeeding
* Takes either angiotensin-converting enzyme inhibitor or angiotensin II receptor blockers for hypertension
Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

This primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + a FDC containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, antiretroviral treatment-naive adults.


Eligibility Criteria:
Key Inclusion Criteria:

* Antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening
* Plasma HIV-1 ribonucleic acid (RNA) levels ≥ 500 copies per milliliter (mL) at screening
* Adequate renal function: Estimated glomerular filtration rate ≥ 30 mL per minute (min) (≥ 0.50 mL per second (sec)) according to the Cockcroft-Gault formula

Key Exclusion Criteria:

* An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening
* Decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)
* Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
* Females who are pregnant (as confirmed by positive serum pregnancy test)
* Females who are breastfeeding

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
ADASUVE 2-dose Thorough QT/QTc Study

Assess the potential effects on the QT interval of 2 consecutive doses of ADASUVE administered 2 hours apart, in relation to placebo and an active control in healthy volunteers.

It has been shown in a pre-marketing clinical study that clinically relevant QT prolongation does not appear to be associated with a single dose of ADASUVE. The potential risk of QTc prolongation following repeat dosing is unknown. Therefore the current study will assess the potential effects on the QT interval of 2 consecutive doses of ADASUVE administered 2 hours apart, in relation to placebo and an active control in healthy volunteers.

The study hypothesis H0: Placebo-subtracted max mean dQTc \> 10 msec

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects between the ages of 18 to 65 years, inclusive.
* Body mass index (BMI) ≥18 and ≤32.
* Subjects who are willing and able to comply with the study schedule and requirements, and stay at the CRU for a 4-day period and 2 consecutive 3-day periods.
* Subjects who speak, read, and understand English and/or Dutch and are willing and able to provide written informed consent on an IEC approved form prior to the initiation of any study procedures.
* Subjects who are in good general health prior to study participation
* Female or male participants who agree to use a medically acceptable and effective birth control method

Exclusion Criteria:

* Subjects who regularly consume large amounts of xanthine-containing substances (≥ 5 cups of coffee/day).
* Subjects who have taken prescription or nonprescription medication within 5 days of Visit 2.
* Subjects who have had an acute illness within the last 5 days of Visit 2.
* Subjects who have smoked tobacco within the last 30 days or who have a positive cotinine test.
* Subjects who have a history of HIV, anti-HCV or HbsAg positivity.
* Subjects who have a history within the past 2 years of drug or alcohol dependence or abuse as defined by DSM-IV.
* Subjects who test positive for alcohol or have a positive urine drug screen.
* Subjects who have a history of allergy or intolerance to loxapine or amoxapine or history of bronchospasm following inhaled loxapine treatment.
* Subjects who have an ECG abnormality.
* Subjects who have hypotension, or hypertension.
* Subjects who have a history of unstable angina, syncope, coronary artery disease, myocardial infarction, congestive heart failure, transient ischemic attack, history of convulsions or other neurological disorder.
* Subjects who have a current history of asthma, chronic obstructive lung disease, or any other lung disease associated with bronchospasm.
* Subjects who use medications to treat airways disease, such as asthma or COPD.
* Subjects who have any acute respiratory signs/symptoms (e.g., wheezing).
* Female subjects who have a positive pregnancy test at screening or at admission to any of the treatment visits, or are breastfeeding.
* Subjects who have received an investigational drug within 60 days prior to the Screening Visit.
Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography

This is a multi-center cohort study in which the Real-time Tissue Elastography® measurements will predict prospectively the incidence of hepatocellular carcinoma, the incidence and severity of gastroesophageal varices ascites and decompensated cirrhosis in hepatitis B or C patients.

The aim of this study is to validate the predictive value of Real-time Tissue Elastography® by comparison with serum marker or FibroScan® in chronic hepatitis B or C patients.

Every year and for three years, we performed Real-time Tissue Elastography®, blood sampling, gastrointestinal endoscopy. If in the hospital they can perform FibroScan®, FobroScan® also be performed.

Subjects were also performed ultrasonography (US), computed sonography (CT) or magnetic resonance imaging (MRI) evry four or six months.

The time between the Real-time Tissue Elastography®, blood sampling, gastrointestinal endoscopy and FiroScan® must not exceed four weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female and at least 20 years of age
* Chronic hepatitis B or Chronic hepatitis C

Exclusion Criteria:

* Evidence or history of hepatocellular carcinoma
* History of alcohol abuse (alcohol intake \> 20g/day)
* Pregnant or lactating patients
* Psychosis
Heparin-Induced Thrombocytopenia: Development and Validation of a Predictive Clinical

Although Heparin-induced thrombocytopenia (HIT) is a rare complication of heparin treatment, it results in a high rate of morbidity and mortality, the cumulative rate of thrombosis recurrence, amputation and death approaching 52 % at one month if no specific treatment is initiated. It is therefore vital to diagnose HIT as early and as reliably as possible to permit appropriate management of this rare condition.

During the acute phase of HIT, clinicians and biologists can only suspect this complication with a greater or lesser degree of confidence. Clinical data are not sufficiently sensitive or specific to confirm or refute thr diagnosis of HIT.

Purpose : To create and validate a score predicting the diagnosis of HIT

Eligibility Criteria:
Inclusion Criteria:

* all patients presenting, either during or immediately after treatment:

  * thrombocytopenia and/or venous or arterial thrombosis
  * for whom a request for biological assessment to check for HIT (anti-H-PF4 ELISA test) is to be addressed to the specialized haemostasis laboratory participating in the study

Exclusion Criteria:

* do not possess sufficient clinical data prior to performance of the biological test
* cannot assure follow-up of the patient until normalization of the platelet count
Blood Pressure Treatment in ICU Patients with Subarachniodal Haemorrhage.

An MRI study to examine the relationship between blood pressure and cerebral blood flow in patients with subarachnoidal hemorrhage and suspect or verified vasospasm.

Subarachnoidal hemorrhage (SAH) is a type of stroke with high mortality rates and often requires care at the intensive care unit. Cerebral blood flow (CBF) needs to be ensured so that the brain receives optimal nourishment, and this is largely controlled by regulating blood pressure (BP) using medications that affect the heart and blood vessels. Approximately 3-7 days after SAH onset, vasospasm (SAH-V) can occur. Treatment usually includes maintaining blood pressure (BP) above a certain threshold to achieve adequate cerebral blood flow (CBF). An important component of raising BP is increasing vascular resistance using vasoconstrictive medications, which paradoxically can decrease CBF.

The study objective is to investigate the correlation between BP changes and their impact on CBF in patients with suspect or verified SAH-V using MRI.

To achieve this purpose, the investigators plan to examine the relationship between BP and CBF in patients with SAH-V who require neuro-intensive care. To measure CBF, two techniquis will be used: phase-contrast MRI and arterial spin labeling.

Flow measurement with MRI:

1. Baseline images will be acquired at baseline blood pressure.
2. Mean arterial pressure (MAP) will be increased using norepinephrine. New images will be acquired when MAP is increased by approximately 20-30% from the baseline.

All BP levels will be maintained within clinically acceptable ranges. All data will be recorded in the patient's medical record, and MRI images will be processed at a later stage.

Eligibility Criteria:
Inclusion Criteria:

* Coiled or clipped aneurysm
* Suspected or confirmed vasospasm

Exclusion Criteria:

* BMI \>30
* Pregnancy
* Pacemaker or other MRI contraindications
* Severe congestive heart failure (NYHA III-IV) or cardiac arrhythmia.
* Severe respiratory failure or FiO2 \>0.6
* Severe kidney failure