cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate Hemodynamic Effect of Different Loading Doses of Precedex in Post-surgical Intensive Care Unit (ICU) Patients

The objective of this study is to characterize the hemodynamic effects of Precedex (dexmedetomidine (DEX)) during 3 loading-dose paradigms in mechanically ventilated post-surgical subjects in an intensive care setting.


Eligibility Criteria:
Inclusion Criteria:

1. Subject or the subject's legally authorized representative has voluntarily signed and dated the informed consent document approved by the Research Ethics Board (REB).
2. Initially intubated and mechanically ventilated adult post-operative subjects in an intensive care setting (e.g., post operative care unit, post anesthesia care unit, etc.) that are expected to require sedation for at least 2 hours.
3. Has an American Society of Anesthesiologist (ASA) classification of 1, 2, 3 or 4.

   ASA Physical Status Classification System
   * P1 A normal healthy subject
   * P2 A subject with mild systemic disease
   * P3 A subject with severe systemic disease
   * P4 A subject with severe systemic disease that is a constant threat to life
   * P5 A moribund subject who is not expected to survive without the operation
   * P6 A declared brain-dead subject whose organs are being removed for donor purposes.
4. If female, subject must be postmenopausal, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least one of the following methods of birth control:

   * hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration
   * intrauterine device (IUD)
   * double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream).

Exclusion Criteria:

1. Subjects \<18 years of age.
2. Subjects with a 2nd degree Mobitz Type II or 3rd degree heart block, unless the subject has a permanent pacemaker or pacing wires are in situ.
3. Subjects with a known allergy to dexmedetomidine.
4. Hypotension based on repeat assessments prior to (within 15 minutes) starting study drug defined as Systolic BP \<90 mmHg or Diastolic BP \<60 mmHg.
5. Pre-existing bradycardia prior (within 15 minutes) to starting study drug defined as HR \<50 bpm.
6. Subjects who, in the opinion of the Investigator, have any other condition where the risks of dexmedetomidine would be expected to outweigh its benefits (e.g., cardiogenic shock on \>2 vasopressors, death anticipated within 48 hours).
Analysis of Respiratory Mechanics in Patients With Rheumatoid Arthritis

Rheumatoid arthritis (RA) is an autoimmune disease of unknown etiology characterized by peripheral polyarthritis, symmetric, which leads to joint destruction and deformity. It is estimated that the RA reaches about 0.5% of the population. According to data from DATASUS, was responsible for 26,671 hospitalizations, 229 deaths and cost exceeding R$ 20 million in 2005-2007.

The main bodily changes are related to joint problems, however, systemic manifestations are also found in organs such as lung and heart. Although cardiovascular diseases are the most responsible of the deaths AR, pulmonary complications are common and account for 10% to 15% of all mortality. Anaya and colleagues point out that the pulmonary involvement contributes significant morbidity and mortality in these patients. Although pulmonary involvement is a frequent manifestation in RA, the prevalence and nature of rheumatoid lung disease has not yet been precisely established. Several lung disorders such as interstitial pulmonary fibrosis, pulmonary nodules and bronchiolitis may ocorrer1. Laitinen et al point out that studies of lung function appear to be a valuable helper for radiography in the evaluation of pulmonary involvement in connective tissue diseases. Previous studies indicate that patients with RA have an increased incidence of abnormal lung function, according to assessments including spirometry, lung volume tests and diffusion capacity of carbon monoxide.

Thus, the main objective of this study is to analyze the respiratory mechanics of patients with RA. Specific objectives were to seek to understand whether a relationship exists between duration of rheumatoid disease and lung function in these patients.

For this, the investigators used 18 subjects in the control group, free of pulmonary disease and / or heart, all nonsmokers. In the RA group, a total of 72 patients divided into 4 groups of 18 volunteers each, classified according to disease duration (0-5 years, 6-10 years, 11-15 years and\> or = 16 years). It is noteworthy that all patients in the RA group will also be non-smokers, since it is already known in the literature that smoking impairs lung function. All individuals will perform the function test with a trained technician and qualified to function. The examinations will be conducted: Forced oscillation technique and spirometry, in that order.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers with Rheumatoid Arthritis for Patients Group;
* Volunteers without any respiratory disease for the control group.

Exclusion Criteria:

Smokers
Hip-Fracture Surgery on Patients in Clopidogrel Therapy

Patients in Clopidogrel therapy alone or in combination with acetylsalicylic acid (Dual Antiplatelet Therapy (DAPT) presenting with a hip-fracture represent the surgeon with the dilemma of putting the patient at risk of a major blood loss during and after surgery, or putting the patient at risk of a thromboembolic event after surgery. The investigators hypothesize that the risk of a major blood loss in patients that are still under the effect of Clopidogrel or DAPT during or after hip-fracture surgery is relatively low. The investigators have conducted a retrospective observational study on hip-fracture patients to test this hypothesis.


Eligibility Criteria:
Inclusion Criteria:

* All patients operated with short intramedullary nail for hip-fractures, in the study period. (1st of Jan. 2011-31st of Dec. 2013)

Exclusion Criteria:

* patients operated \>24 hours after admission, patients in other forms of anticoagulation medication except acetylsalicylic acid (including vitamin K antagonists, dipyridamole, dabigatran, apixaban and rivaroxaban), missing data on blood loss in patient chart, missing blood samples in the first 4 days and extra-national patients (follow up not possible). Patients operated on both sides during the inclusion period were only included with data on their latest operation.
Preventing Weight Regain Post-Semaglutide Treatment With Active Fiber Supplement (Soloways)

This randomized, double-blind, placebo-controlled trial titled "Preventing Weight Regain Post-Semaglutide Treatment with Active Fiber Supplement (Soloways)" evaluated the efficacy of an active fiber supplement in preventing weight regain post-Semaglutide treatment. Participants were adults aged 18-65, with a history of obesity or overweight, and had completed a Semaglutide course. The study involved 160 participants, equally divided into two groups: one receiving the active fiber supplement (glucomannan, inulin, and psyllium) and the other a placebo, both taken 30 minutes before each main meal for 180 days. Co-primary endpoints were the percentage of weight regain from baseline to day 180 and metabolic health markers (blood glucose levels, HbA1c, lipid profile, blood pressure). Secondary endpoints included changes in BMI, body composition, and appetite assessment using VAS ratings and the Control of Eating Questionnaire (CoEQ). Participants also adhered to a reduced-calorie diet and increased physical activity, with all standard assays performed in a central laboratory. The study's objective was to determine the supplement's effectiveness in enhancing satiety, improving digestive health, and thus better managing weight compared to a placebo


Eligibility Criteria:
Inclusion Criteria:

* Adults with a history of obesity or overweight and completed Semaglutide course.
* Age 18-65 years.-

Exclusion Criteria:

* Serious chronic illnesses.
* History of bulimia or anorexia.
* Pregnancy or lactation.
Screening Non Small Cell Lung Cancer With Bone Metastasis and Efficacy and Safety Research of Receiving Bisphosphonates

A multicenter Prospective Study to assess the screening methods, parameter of NTX and the efficacy and safety of zoledronic acid treatment in addition to anti-tumor therapy in patients of non-small cell cancer with bone metastasis in china.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>18, either sex
2. Histologically confirmed non-small cell cancer
3. One bone metastasis at least confirmed by image(X ray,CT or others)
4. Without receiving zoledronic acid
5. Life expectancy \> 6 M
6. ECOG \<= 2
7. Signed ICF

Exclusion Criteria:

1. Women who are pregnant or in lactation
2. Patients with hyperostosis
3. with brain metastasis(exception of those without symptom or with Metastasis Lesions under controlled
4. Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy
5. Severe co-morbidity of any type that may interfere with assessment of the patient for the study -
Bioequivalence Test for Risperdal 2mg of Janssen Korea

The purpose of this study was to conduct the bioequivalence (biological equivalence of two preparations of a drug) test in healthy adults with "Risperdal OD Tab. 2mg" of Janssen Korea as the investigational drug and "Risperdal Quicklet Tab. 2mg" as the control drug.

This was a randomized (the study drug is assigned by chance) and open labeled (all people know the identity of the intervention) study. All participants were hospitalized in research rooms and were subsequently restricted in exercise, eating, drinking, smoking and xanthine-beverages until the end of blood collection. Water was allowed to be taken until one hour before drug administration. Participants were randomly assigned into two groups, one group receiving Risperdal OD (investigational drug), and one group receiving Risperdal Quicklet (control drug). On the day of testing, blood was collected from all participants to provide baseline measurements. Subsequently, the study drug was orally administered to the participants, followed by blood collection of a total of 13 time points, up to 24 hours. After the blood collection was finished, participants were discharged after receiving proper guidance and being examined by a psychologist. Following a wash-out period (period when receiving no intervention) of one week, participants were hospitalized once more and crossed over to receive the study drugs following the same procedure above described. The approximate study duration (including the drug administration days and wash-out period) was approximately 10 days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Korean participants weighing more than 50kg and within 20% normal lean body weight (standard weight)
* Participant without congenital or chronic diseases and with no symptoms or findings as a result of internal examination
* Participant who was deemed appropriate as a result of inquiry, blood pressure, physical examination, electrocardiogram, blood and urinalysis, etc., within 28 days prior to the first administration of the investigational drug according to the protocol
* Female participant who was confirmed as non-pregnant through urine test during health examination

Exclusion Criteria:

* Participant who had a history of disease related to cardiac, respiratory, hepatic, renal, gastrointestinal or nervous system, or cardiac infarction, stroke, hypertension, arrhythmia, coronary artery disease, or neuropsychiatric diseases that could affect drug absorption, distribution, metabolism and excretion or could be risk factors when taking drugs used for the clinical trial, a history of gastrointestinal surgery except appendectomy or herniotomy, or who currently had abnormality in inquiry or physical examination
* Participant who showed symptoms that were suspected as acute disease within 14 days from the first administration of the investigational drug
* Participant with allergic disease requiring treatment
* Participant who had a history of being hypersensitive to drugs or food
* Patient who had hepatitis B antigen or who showed hepatitis C positive antigen
Eyelash Line Resection for Entropion Associated With Down's Syndrome

Surgical outcome of entropion associated with Down's syndrome was evaluated. Grading scale of superficial punctate keratopathy and score of wearing glasses to correct refractive errors were measured.


Eligibility Criteria:
Inclusion Criteria:

* The patients with entropion with Down's syndrome

Exclusion Criteria:

* The patients of Down's syndrome who do not have entropion.
A Study to Evaluate EDP-235 in Non-hospitalized Adults With COVID-19

Study of EDP-235 in Non-hospitalized Adults with Mild or Moderate COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* SARS-CoV-2 infection confirmed by positive test ≤24 hours before randomization
* COVID-19 symptom onset within 5 days prior to randomization and at least 2 signs/symptoms attributable to COVID-19 present and one of at least moderate severity at Screening

Exclusion Criteria:

* Prior SARS-CoV-2 infection \<90 days before enrollment and/or received any COVID-19 vaccine dose \<90 days before enrollment
* Has one or more conditions associated with high risk for severe COVID-19
* History of hospitalization for the medical treatment of COVID-19
* Currently hospitalized or anticipated need for hospitalization in the clinical opinion of the investigator
* Known medical history of active liver disease
* Receiving dialysis or have known moderate to severe renal impairment
* Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study drug
* Any comorbidity requiring hospitalization and/or surgery within 7 days before study entry, or that is considered life threatening within 30 days before study entry
* Known HIV infection with a HIV viral load greater than 400 copies/mL or medication for HIV treatment that is prohibited in this study based on medical history within 6 months before the screening visit
* History of hypersensitivity or other contraindication to any of the components of the study drug
* Has received or is expected to receive pre-exposure prophylactic SARS-CoV-2 mAb
* Has received or is expected to receive convalescent COVID-19 plasma
* Oxygen saturation of ≤93% on room air obtained at rest within 24 hours before randomization
* Participating in another interventional clinical study with an investigational agent or device, including those for COVID-19, within 30 days or five half-lives of the agent, whichever is longer, before signing the ICF
* Females who are pregnant or breastfeeding
Lixisenatide for Restoration of Insulin Release in Subjects With Diabetes Mellitus Type 2

The objective of this study is to test whether Lixisenatide (AVE0010) restores first phase and improves second phase insulin response in subjects with diabetes mellitus type 2.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with type 2 diabetes mellitus on diet and exercise with/without metformin
* HbA1c\>=6,0 % and \<=8,5 % at screening
* BMI 25 to 35 kg/m²
* 155\>=BP systolic \>=90 mmHg
* 100\>=BP diastolic\>=45 mmHg

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Gallium Ga 68-labeled PSMA-11 PET/CT in Detecting Recurrent Prostate Cancer in Patients After Initial Therapy

This clinical trial studies how well gallium Ga 68-labeled prostate-specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) works in detecting prostate cancer that has come back (recurrent) in patients after initial therapy. Diagnostic procedures, such as gallium Ga 68-labeled PSMA-11 PET/CT, may help doctors detect tumors that have come back after initial therapy.

PRIMARY OBJECTIVE:

I. To assess the sensitivity on a per-patient and per-region-basis of Gallium Ga 68 Gozetotide (68Ga-PSMA-11) PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.

SECONDARY OBJECTIVES:

I. To assess the positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up (composite reference standard).

II. To assess the sensitivity and positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy only.

III. To assess the detection rates on a per-patient basis of 68Ga-PSMA-11 PET stratified by prostate specific antigen (PSA) value (0.2 - \< 0.5, 0.5 - \< 1.0, 1.0 - \< 2.0, 2.0 - \< 5.0, \>= 5.0).

IV. To assess the impact of 68Ga-PSMA-11 PET on clinical management in biochemical recurrence (BCR) patients.

V. To assess the inter-reader reproducibility. VI. To assess the safety of 68Ga-PSMA-11 PET. VII. To assess the detection rates on a per-patient basis of 68Ga-PSMA-11 PET stratified by PSA velocity and PSA doubling-time.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV). Beginning 50-100 minutes after receiving gallium Ga 68-labeled PSMA-11, patients undergo PET imaging.

After completion of study, patients are followed up for 3-12 months.

Eligibility Criteria:
Inclusion Criteria:

* Histopathological proven prostate adenocarcinoma
* Rising PSA after definitive therapy with prostatectomy or radiation therapy.

  * Post radical prostatectomy (RP)

    * PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP
  * Post-radiation therapy - American Society for Therapeutic Radiation and Oncology (ASTRO)-Phoenix consensus definition

    * Nadir + greater than or equal to 2 ng/mL rise in PSA
* Karnofsky performance status of \>= 50 (or Eastern Cooperative Oncology Group \[ECOG\]/ World Health Organization \[WHO\] equivalent)
* Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria:

* Concomitant investigational therapy
* Known inability to lie flat, remain still or tolerate a PET scan
* Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer
Educators and Young People's Mental Health

The aim of the present study is to assess the current state of mental health of educators and young persons at the education centre for health and care professions in St. Gallen (BZGS) by conducting screening instruments. Furthermore, the investigators aim to identify risk and protective factors for the mental health of vocational trainees in health and care professions.

These results are both essential for further research and educational practice. Moreover, results may maximise the chances of creating in future meaningful intervention for young persons in this specific setting.

Background:

Young person's undergoing training in the health or social services sector are confronted with issues such as dying, illness and severe personal tragedies while they are still in the process of their own development. This can have serious effects on their mental health. During this time, vocational school is a central part of young persons' lives. The YouCoMent project will initiate a sustainable promotion and maintenance of mental health and thus preventively counteract the development of mental health conditions.

In order to meet the special challenges of vocational schools in the health sector, this study pursues the following objectives:

To assess the current state of mental health of young persons at the educational centre.

To identify individual risk and protective factors for the mental health of young persons.

Methods:

This study is the first part of the YouCoMent project, which will be carried out at the education centre for health and care professions in St. Gallen (BZGS), Switzerland between 2023 and 2026.It has approx. 150 educators. The number of trainees in basic training is about 2800.

Every person will be asked through the BZGS internal E-Mail distribution lists to participate. Beforehand, between 20 and 24 January 2023. Data collection will be conducted on T1: 26 January 2023 and T2: 24 January 2025. Participation in the study is voluntary. The data collection is going to be carried out using a self-administered online questionnaire. Data collection will be conducted in anonymous form.

The quantitative data will be analysed using descriptive and, where appropriate, exploratory statistics, as well as analysed with statistical software (SPSS). The statistical analyses are carried out by researchers at the University of Applied Sciences of Eastern Switzerland in St. Gallen.

Eligibility Criteria:
Inclusion Criteria:

* All trainees at the centre

Exclusion Criteria:

* under age of 14
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1019" and Co-administration of "BR1019-1" and "BR1019-2"

The objective of this clinical study is to evaluate the pharmacokinetics and the safety after administration of "BR1019" and co-administration of "BR1019-1" and "BR1019-2" in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Those who have body mass index (BMI) within the range of 18.0 to 30.0kg/m² at screening visit

  * In case of a male subject, Those who weigh 50 kg or more
  * In case of a female subject, Those who weigh 45 kg or more
* Those who decide to voluntarily participate after listening to and understanding the detailed explanation of this clinical trial and who sign a written consent to comply with the subject's precautions during this clinical trial.

Exclusion Criteria:

* Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken ETC, OTC, Oriental medicine, Health functional food concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs, etc.)
* Those who have participated in bioequivalence tests or other clinical trials administered their investigational products within 6 months prior to the first administration date. (However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
* Those who have a medical history of gastrectomy(Except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs.
* Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or its products, etc.) that may affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours prior to the first day of administration.
* In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.