cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Effects of Remifentanil and Dexmedetomidine Administered Under General Anesthesia in Rhinoplasty

The investigators compared the effects of remifentanil and dexmedetomidine administered under general anesthesia on hemodynamics, postoperative pain, recovery, postoperative nausea, vomiting, shivering, patient's and surgeon's satisfaction in patients undergoing elective rhinoplasty. A single-center, prospective, blinded, randomized controlled trial. After the approval of the hospital ethics committee (KA22/12), fifty volunteers aged 18-65 years who underwent rhinoplasty under elective conditions accepted the study in the American Society of Anesthesiologists (ASA) I-III class. The patients were randomly divided into the remifentanil group (group R) and the dexmedetomidine group (group D). Group R (n=25) was initially to receive remifentanil 0.01-0.2 g/kg/min without intraoperative loading. Group D (n=25) dexmedetomidine, was initiated with a bolus of 1 mg/kg and received 0.2-0.7 g/kg per hour as an infusion during surgery.


Eligibility Criteria:
Inclusion Criteria:

Patients who will have rhinoplasty surgery American Society of Anesthesiologists (ASA) I- II class

Exclusion Criteria:

Patients with end-stage liver or kidney disease Uncontrolled hypertension Any type of atrioventricular block, pacemaker Heart failure Diabetes mellitus Chronic obstructive or interstitial lung disease, severe asthma Neurological or psychiatric disease, substance abuse Pregnant or lactating women
Application of Unilateral Epidural Anesthesia in Older Patients With Hip Fracture

Because of population ageing, fragility fractures have become a huge burden on healthcare systems and wider society. Fractures result in a sharp drop in both short-term and long-term quality of life, they have a strong influence on activities of daily living and mobility, and they are associated with a significant increase in 1-year mortality (18%-36%). Surgery can benefit elderly patients with hip fractures to an extent, but it entails inevitable risks, particularly with respect to general anesthesia. In recent years unilateral spinal anesthesia has attracted attention due to the advantages of hemodynamic stability, reduced anesthetic dosage, and sufficient sensory block.

On the basis of a previous study, in the current study anesthetics were directly implanted into the unilateral epidural space in elderly patients with hip fractures prior to the completion of surgery. Data from 106 patients with old hip fractures who had undergone surgical treatment incorporating unilateral epidural anesthesia (UEA) or combined lumbar and epidural anesthesia were retrospectively analyzed in an attempt to provide a feasible solution for this kind of patients' anesthesia.

Surgery can benefit elderly patients with hip fractures to an extent, but it entails inevitable risks, particularly with respect to general anesthesia. In recent years unilateral spinal anesthesia has attracted attention due to the advantages of hemodynamic stability, reduced anesthetic dosage, and sufficient sensory block. On the basis of a previous study, in the current study anesthetics were directly implanted into the unilateral epidural space in elderly patients with hip fractures prior to the completion of surgery.

Eligibility Criteria:
Inclusion Criteria:

had a fracture of a proximal femur were aged \> 65 years the fracture occurred within 2 weeks of receiving treatment with comorbidities including pulmonary disease, arrhythmia, senile valve disease or lacunar infarction underwent intraspinal anesthesia during surgery

Exclusion Criteria:

had a secondary fracture after endoprosthetic reconstruction or intramedullary nail had a pathological fracture caused by tumor or tuberculosis condition was accompanied by lower limb nerve dysfunction had a cognitive or psychiatric disorder coagulation disorders hospitalization data were incomplete.
High Flow Nasal Oxygen Versus Usual Care in COPD Pulmonary Rehabiliation

To compare the effects of high flow nasal oxygen with usual care during an outpatient 6-week pulmonary rehabilitation program after hospitalization for COPD exacerbation.

This is a pilot randomized controlled trial to compare the effects of high flow nasal oxygen with usual care during an outpatient 6-week pulmonary rehabilitation program after hospitalization for COPD exacerbation.

Eligibility Criteria:
Inclusion Criteria:

1. Age 21 years and above
2. Known diagnosis of COPD based on history AND spirometry demonstrating post bronchodilator FEV1/FVC ratio \<0.7
3. Currently admitted inpatient for an acute COPD exacerbation as the primary diagnosis
4. Fit to participate in exercise therapy as determined by both physician and physiotherapist
5. Has the mental capacity to follow instructions
6. Experience shortness of breath on exertion
7. Have decreased ability to carry out activities due to shortness of breath
8. Willing to participate in the exercise program

Exclusion Criteria:

1. Uncontrolled/ unstable medical conditions such as severe chronic heart failure that make exercise unsafe
2. Pulmonary disorder other than COPD
3. Physical conditions that preclude the ability to participate in exercise or may impair exercise performance.
Adherence to Oral Therapies in Advanced Breast and Prostate Cancers

AdOTAC is a pilot study, open, prospective, single-center, one-arm. The 200 patients will be included. Patient is included at Day 0. The included patient will have the opportunity to complete the self-questionnaires either at the ICL on Day 0, or at home up to 10 days after the date of inclusion in the study. Blood samples are collected the day of enrolment (Day 0) in order to measure the following biological markers: ferritin, serum iron, TSAT, albumin, and haemoglobin, except if performed as part of routine care in the previous 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult over 18 years old.
* Patient with inoperable advanced breast cancer treated with oral endocrine therapy and/or targeted therapy and patient with inoperable advanced prostate cancer treated with oral hormonal therapy and/or targeted therapy.
* Oral anticancer medications started for at least 3 months.
* With a performance status ≤ 3.
* Patient has understood, signed and dated the consent form.
* Patient covered by the social security system.

Exclusion Criteria:

* Patient with early breast cancer or localized prostate cancer.
* Patient with life expectancy \< 3 months.
* Patient in progression
* Undergoing intravenous or oral cytotoxic chemotherapy (capecitabine, cyclophosphamide, vinorelbine).
* Patient who has not yet started oral anticancer therapies or who has started for less than 3 months.
* Patient unable to read or speak French.
* Patient already included in another therapeutic trial with an experimental molecule.
* Persons deprived of their liberty or under guardianship (including curatorship).
The Effectiveness of Information and Relaxation on Pre-procedural Block Anxiety and Procedural Discomfort During Medial Branch Block

Patient presenting to chronic pain clinics frequently undergo diagnostic and therapeutic spinal injections as part of their treatment. These procedures can cause significant level of apprehension in patients, which can lead to increased procedural times, increased procedural pain and reluctance to continue with the treatment program. It appears that certain interventions could reduce the anxiety and catastrophization levels and modify pain perception during medical procedures. The investigators therefore sought to evaluate the effect of a single 30 minutes information session which includes relaxation training administered 5 to 6 days before the nerve block procedure on patient's anxiety and catastrophization levels prior to the procedure and pain scores during the procedure, as well as the overall level of satisfaction with care received.


Eligibility Criteria:
Inclusion Criteria:

* patient scheduled to have a medial branch block
* over 18 years of age

Exclusion Criteria:

* adult able to give their own consent
* patients who had a previous nerve block
* patients who have a major psychiatric illness
* patients who do not understand English or French
A Study of Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia

This single-arm study will assess the efficacy and safety of intravenous (IV) Mircera when administered for the maintenance of hemoglobin (Hb) levels in participants with chronic renal anemia. Individuals currently receiving maintenance treatment with epoetin alfa or darbepoetin alfa will receive monthly injections of Mircera, with the starting dose (120, 200, or 360 micrograms \[mcg\] IV injection) derived from the dose of epoetin alfa or darbepoetin alfa they were receiving in the week preceding study start.


Eligibility Criteria:
Inclusion Criteria:

* Adults greater than or equal to (≥) 18 years of age
* Chronic renal anemia
* Stable epoetin alfa or darbepoetin alfa therapy for past 2 months
* Hemodialysis therapy for ≥3 months

Exclusion Criteria:

* Transfusion of red blood cells during previous 2 months
* Poorly controlled hypertension requiring hospitalization or interruption of ESA treatment in previous 6 months
* Acute or chronic bleeding
Comparison of Two Heparin Formulations in Patients With Chronic Renal Failure.

Investigate, through a randomized, open, parallel and comparative, non-inferiority of heparin sodium produced by laboratory Hipolabor compared to heparin manufactured by APP in patients on hemodialysis due to renal failure, through the control of hemostasis, verified by formation of clot (fibrin) in the hemodialysis system and pharmacodynamic parameters (TTPA and Anti-Xa) during the use of heparin


Eligibility Criteria:
Inclusion Criteria:

1. Research that patients agreed to participate and signed the written informed consent;
2. Patients aged over 18 years, both sexes, regardless of color or social class;
3. Patients with impaired renal function in chronic hemodialysis schedule of at least 3 times a week and giving the use of heparin in the prophylaxis of thrombosis in the system.

Exclusion Criteria:

1. Hypersensitivity to heparin sodium and / or benzyl alcohol;
2. History of bleeding or disease that the change of blood coagulation could aggravate or terminate the clinical manifestations, such as tables of active peptic or gastric ulcer;
3. Severe liver disease;
4. Cancer;
5. Period of gestation;
6. Genetic abnormality of the coagulation system;
7. Multiple trauma;
8. Use of aspirin in high doses (above 200mg per day);
9. Use of glucocorticoids for at least 1 month;
10. Use of other anticoagulants;
11. Submission of a big surgery done less than 15 days;
12. History of persistent hypertension at the end of dialysis than 150/100 mmHg;
13. Indicated doses of heparin 20% above or below 150UI/kg.
Internet-Based Stress Recovery Program FOREST+ for Healthcare Workers

The study aims to assess the efficacy of an internet-based stress recovery intervention for healthcare workers receiving therapist support with or without an intervention plan.

The intervention will be delivered as an internet-based stress recovery program for healthcare workers, comprising of six modules: introduction, psychological detachment, distancing, mastery, control, and keeping the change alive. These modules have been chosen after considering themes that could be most useful for healthcare workers under high stress. Each module consists of a psychoeducational and an exercise component. An intervention plan will be drawn up with the therapist prior to the start of the program, setting the intensity of engagement and the frequency of reminders. During the program, a therapist provides individual feedback on the completed exercises and can also be available on request.

The effect of the intervention will be compared with a control group that will use the program without an intervention plan. The intervention will be delivered in Lithuanian.

Eligibility Criteria:
Inclusion Criteria:

* licensed healthcare professionals currently working under license;
* at least 18 years old;
* comprehending Lithuanian language;
* access to internet.

Exclusion Criteria:

* acute psychiatric crisis;
* high suicide risk;
* interpersonal violence.
Chinese Liver Cancer Clinical Survey

In order to make better use of clinical resources of the real world, strengthen the standardization of PLC diagnosis and treatment, and constantly improve the academic level of liver cancer in China, we intends to launch "Chinese Liver Cancer clinical Survey" project in cancer specialized hospitals and large general hospitals and to explore the best clinical pathway of PLC multidisciplinary consultation.

Primary liver cancer (PLC) is one of the most common malignant tumors of digestive system and also a serious threat to the health and safety of Chinese people, and has caused serious economic burden to the country. Research purposes: To understand the clinical characteristics of patients with primary liver cancer (PLC) in China; To investigate the etiology and pathogenesis of PLC in China; To understand the current status of clinical treatment of PLC in China, and to analyze the gaps among these conditions and domestic treatment guidelines, industry consensus, the international treatment guidelines; To understand the different treatment options and its clinical outcomes, and to explore the best treatment options; To explore the best clinical pathway of PLC multidisciplinary consultation; To provide the basis for the development of clinical guidelines for PLC in China.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PLC after January 1,2012;
* First treatment and efficacy evaluation.

Exclusion Criteria:

* Complicated with another primary malignant tumor and secondary liver cancer.
Immunogenicity of Seasonal Influenza by Delivery Directly to Ileum

the purpose of the study is to determine the safety and tolerability of VXA-A1.1, an adjuvanted adenoviral based influenza vaccine, when delivery is targeted to the ileum, using a radio controlled capsule. The secondary objective is to evaluate the immune response (cellular and humoral) of two doses of VXA-A1.1 oral vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to complete informed consent
* Healthy, as established by medical history, physical exam, and laboratory assessments
* Has normal bowel movements
* Willing to abstain from caffeine and xanthine containing substances for 24 hours before procedure until after discharge

Exclusion Criteria:

* Not able to donate up to 550 ml of blood over several months
* Exposure to an investigational drug or vaccine 8 weeks prior to study
* Abnormal ECG findings
* History of irritable bowl or any other inflammatory gastrointestinal disorder
* Any individual with increased risk for bowl obstruction
* Radiation exposure above target values 50 mSv within the past 30 days or a cumulative dose above 150 mSV in the past 12 months
* History of substance abuse
* Subject unwilling to use an approved method of contraception during study and for 2 months after study
* Positive for HCV, HIV, or HBV
* Presence of implantable device that is sensitive to radio frequencies ( e.g. pacemakers)
* History of autoimmune disorder, or an immunosuppressive disorder
* Stool sample with occult blood at baseline
* Any other medical, psychiatric, social condition, or occupation, in the judgement of the investigator is a contraindication to the compliance of the protocol or informed consent
Saline Challenge in Monitoring Asthma Control

It is generally accepted that symptoms and lung function are not sufficient ways to monitor asthma control. Therefore, several objective tests have been developed to help asthma control monitoring, each having their own shortcomings. We have developed a new test, the hypertonic saline cough challenge. In our previous publication this test has proven useful in diagnosing asthma. The present study is planned to investigate whether hypertonic saline cough challenge could be used to monitor asthma control. A group of steroid-naive asthmatics will be recruited. A treatment with inhaled budesonide is started. Asthma control is monitored at regular intervals utilising a validated questionnaire. At the same time points, hypertonic saline cough challenges will be performed. We will analyse whether changes in the responsiveness to the cough challenge reflects the changes in asthma control


Eligibility Criteria:
Inclusion Criteria:

* symptomatic asthma

Exclusion Criteria:

* usage of inhaled or oral corticosteroids
* recent febrile respiratory infection
* severe, unstable asthma
Telbivudine Versus the Combination of Telbivudine and Valtorcitabine in Patients With Chronic Hepatitis B

This study is being conducted to compare the effectiveness of the combination of valtorcitabine and telbivudine to telbivudine alone in patients with chronic hepatitis B.


Eligibility Criteria:
Inclusion Criteria:

* Clinical history compatible with compensated chronic hepatitis B

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Patient is pregnant or breastfeeding
* Patient is co-infected with hepatitis C virus, hepatitis D virus or HIV
* Patient has previously received lamivudine, adefovir dipivoxil or an investigational anti-hepatitis B virus (HBV) nucleoside or nucleotide at anytime.

Other protocol-defined exclusion criteria may apply.
Study Evaluating the Effect of Multiple Doses of Itraconazole on the Drug Lu AF35700 in Healthy Young Men and Women

This study will investigate the effect of multiple doses of the strong P450 enzyme inhibitor itraconazole on the pharmacokinetics of Lu AF35700 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Men, aged ≥18 and ≤55 years. body weight ≥50 kg
* women, aged ≥18 and ≤45 years, body weight ≥50 kg
* Good general health as assessed using detailed medical history, laboratory tests, and physical examination
* Known CYP2D6 and CYP2C19 genotype

Exclusion Criteria:

* Pregnant or lactating
* Subject has previously been dosed with Lu AF35700

Other protocol defined inclusion and exclusion criteria may apply
Trial of One Versus Two Doses of Dexamethasone for Pediatric Asthma Exacerbation

Comparing one versus two doses of oral dexamethasone for the treatment of asthma in the pediatric emergency department.

A randomized double blinded placebo controlled trial comparing one dose of dexamethasone administered in the Emergency Department with two doses, the first given in the emergency department and the second 24 hours after the index ED visit.

Eligibility Criteria:
Inclusion Criteria:

* History of asthma defined as at least two (2) prior episodes of respiratory illness characterized by wheezing treated with inhaled beta agonists

Exclusion Criteria:

* pregnancy
* severe chronic cardiac, respiratory, neurological or neuromuscular disease
* complete resolution of symptoms after one treatment of beta agonists
* severe asthma symptoms as defined by a Pulmonary Index Score of 12 or greater
A Study To Assess The Safety, Tolerability And Pharmacokinetics Of Metronidazole Injection In Healthy Japanese Subjects

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of metronidazole following single and multiple intravenous infusion in healthy Japanese adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese male and/or female subjects.

Exclusion Criteria:

* Subject with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Subject with history of regular alcohol consumption exceeding 7 drink/week for females or 14 drinks/week for males \[1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor\] within 6 months of screening.
Effect of Head Position During Thyroidectomy on Postoperative Cognitive Functions

The aim of our study is to observe the effect of head-neck position of patients scheduled for thyroidectomy, on carotid artery blood flow, regional cerebral oxygen saturation measured using near-infrared spectroscopy technology, and postoperative cognitive dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* undergo a total thyroidectomy operation
* ASA I-II
* euthyroid patients in the preoperative period

Exclusion Criteria:

* Hemoglobin\< 8 g / dl
* Hypertension
* Hyperlipidemia
* Pregnancy
* Patients diagnosed with diabetes mellitus
* Cerebrovascular insufficiency
* Known carotid artery lesion
* Metabolic diseases
* Any intracranial pathology present
* Surgeries exceeding 180 minutes
A Study to Assess the Safety, Tolerability, and Effects in and on the Body of Healthy Young and Elderly Male and Female Subjects of Ascending Multiple Oral Doses of ASP3652

The study investigates how safe ASP3652 is and how well it is tolerated when taken as multiple doses. The study also assesses how quickly and to what extent it is absorbed and eliminated from the body. In addition, the effects of age and gender are investigated.

The study consists of two parts. In Part 1 four dose levels are administered to four separate groups initially. Two additional dosages are then investigated. Subjects receive either a once-daily dose (QD) or twice-daily dose (BID) of ASP3652 or placebo.

Part 2 is performed in one group of elderly healthy male or female (post-menopausal) subjects. Subjects receive either a twice daily dose (BID) of ASP3652 or placebo.

For both parts of the study, the subjects stay in the clinic for one period of 18 days.

This is a Multiple Ascending Dose (MAD) study with two parts. Screening for both parts takes place between Days -28 and -3. Subjects are admitted to the clinic on Day -2, and discharged on Day 16. They return for an End of Study Visit (ESV) between 7 and 14 days after (early) discharge.

Part 1 evaluates the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ASP3652 following ascending multiple oral doses. The initially planned four dose levels or matching placebo are given to four separate groups. Thereafter two additional dosage levels are further investigated. All groups receive a single dose of ASP3652 administered in the morning of Day 1 and Day 14, and twice-daily doses administered from Day 2 to Day 13 under fasted conditions, except the last group which receives all dosages once daily from Day 1 to Day 14.

Part 2 evaluates the safety, tolerability, PK and PD of ASP3652 following ascending multiple oral doses in healthy elderly male and female subjects. This part contains a single, placebo-controlled group. All subjects receive twice daily doses and administration is based on the results of Part 1.

All subjects in both parts receive training for Neurocognitive Test Battery (NTB) and tests for monitoring of psychotropic effects.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 18.5-30.0 kg/m2 for both male and female subjects.
* Male subject is non-fertile, i.e. surgically sterilized or practices an adequate contraceptive method to prevent pregnancies.
* Female subject is of non-child bearing potential, i.e. post menopausal, surgically sterilized, hysterectomy in medical history, or practices adequate (double barrier) non-hormonal contraceptive method to prevent pregnancies.

Exclusion Criteria:

* Pregnant or breast feeding within 6 months before screening assessment.
* Presence or history of any clinically significant psychiatric disorder such as mania, depression or schizophrenia.
* Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit.