cyrilzakka/clinical-trials huggingface dataset:
A Phase I Clinical, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Donepezil Patch in Healthy Male Subjects

Study of the Safety, tolerability and pharmacokinetics with single dose of donepezil patch in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* BMI : more than 20 ㎏/㎡, less than 26 ㎏/㎡
* Systolic blood pressure : more than 90, less than 140 (mmHg)
* Diastolic blood pressure : more than 60, less than 100 (mmHg)

Exclusion Criteria:

* Evidence of clinically significant, severe, active, or unstable gastrointestinal, renal,hepatic, respiratory, hematological, endocrine, or cardiovascular system disease.
* A history of skin disease or skin graft
* Hypersensitivity to donepezil or piperidine derivatives or any of the excipients.
* A known or suspected history of drug or alcohol dependency or abuse
* Patients who have participated in another clinical study within 60 days.
* Whole blood within 60 days, apheresis within 30 days, transfusion within 30 days
* Heavy caffeine intake(more than 5 units/day)
* Heavy alcohol intake(more than 21 units/week)
* Heavy smoker(more than 10 cigarette/day)
* Abnormal clinical laboratory values which are judged clinically significant by the investigator.
* Any condition that would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study.
Qualitative Study About Psychedelics Using in Psychiatric Disorders

This study is set up to better understand the current use of psychedelics in France in the general population. The present focus on individuals who have used any type of psychedelic drug in order to suppress or alleviate a psychiatric symptom in the context of a diagnosed pathology. The data are collected during a semi-structured interview and then studied in a thematic analysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with a psychiatric disorder by a psychiatrist or general practitioner
* Patients used psychedelic or related substances in order to treat psychiatric symptoms
* Patients have given their oral non-opposition
* Patients affiliated to a social security scheme

Exclusion Criteria:

* Patients who don't speak or understand French
* Patients under protection, guardianship or curators
Capecitabine Versus S-1 in Elderly Advanced Gastric Cancer (AGC): Randomized Trial

A significant proportion of advanced gastric cancer (AGC) occurs in individuals 65 years of age and older. In addition, patient delay in seeking care for symptoms results in diagnosis at a more advanced stage than that seen in younger individuals. However, clinical trials on gastric cancer rarely have been available to the elderly. Recently oral 5-FU pro-drugs, which have been reported to have clinically significant response rates and survival with mild or negligible toxicities, have been widely used for the patients with AGC. However, few studies have been conducted in elderly patients.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven gastric or gastroesophageal junction adenocarcinoma
* Metastatic or recurrent unresectable disease
* Measurable lesions (according to Response Evaluation Criteria in Solid Tumors \[RECIST\])
* Age: 65-85 years old
* Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2
* Adequate bone marrow function: absolute neutrophile counts(ANC) ≥ 1,500/ul, platelet count ≥ 100,000/ul, hemoglobin ≥ 9 g/dl)
* Adequate renal function (serum creatinine≤ 1.5)
* Adequate liver function (serum bilirubin ≤ 2 x upper limits of normal \[UNL\], aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x UNL)
* No prior chemotherapy (but adjuvant chemotherapy completed at least 1 year prior to study treatment is allowed with the exception of capecitabine or S-1) Written informed consent was signed by the patient

Exclusion Criteria:

* Previous palliative chemotherapy
* Known allergy to study drugs
* CNS metastasis
* Significant medical comorbidities
* Active ongoing infection which antibiotic treatment is needed.
* Previous ( within 5 years) history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ.
Placebo-Controlled Crossover Study for the Investigation of the Effect of Pantoprazole on Cardiac Contractility

Recently, negative inotropy of pantoprazole has been shown in isolated human myocardium. This study was designed to test the clinical relevance of this finding in healthy volunteers by measuring left ventricular function during infusion of a common intravenous high dose regimen of pantoprazole.

Purpose: Reports on cardiac problems with oral proton pump inhibitors have caused extensive safety reviews by the U.S. Food and Drug Administration. We provide additional data on acute cardiac effects of an intravenous application.

Methods: Echocardiography was performed in 18 healthy volunteers after administration of a common high dose regimen of pantoprazole (80 mg IV bolus followed by 8 mg/h for 1h) or placebo. Design: Randomized, double-blind, placebo-controlled crossover trial.

Results: EF \[%, means+/-S.E.\] in the treatment group (placebo group) was 60.7+/-1.1 (61.2+/-1.7) at baseline, and 62.6+/-1.1 (62.1+/-1.9), 64.7+/-1.6 (63.5+/-1.3), 62.6+/-1.6 (61.0+/-1.6) and 63.0+/-1.4 (61.8+/-1.5) at 7.5, 15, 30 and 60 min after bolus application, respectively (p = n.s.). Similarly, no significant changes were found for cardiac output, cardiac index, blood pressure, and heart rate. In contrast, gastric pH that was used as a treatment control was significantly increased 60 min after application of pantoprazole as compared to baseline and to placebo.

Conclusions: Pantoprazole for injection is safe in healthy subjects with respect to cardiac contractile function. However, in view of recent reports of negative inotropy of the drug further studies in heart failure patients are required.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 or \< 40 years
* No signs of overt heart failure
* Echocardiographic ejection fraction \>= 55%
* Body Mass Index 20 - 25 kg/m²
* Excellent sonographic conditions
* Non-smoker
* Informed consent

Exclusion Criteria:

* History of cardiac disease
* History of other relevant pre-existing illness
* Pathologic findings in clinical examinations
* Pathologic echocardiographic findings
* Pathologic ECG findings
* Pathologic laboratory findings
* Pregnancy and lactation
* No or insufficient contraception
* Intolerance of pantoprazole
* Alcohol or drug abuse
A New Surgical Instrument in Treatment of Conlylar Fracture: Condylar Reductor

In condylar fracture surgery, reduction is the most difficult step and the key factor which determined the postoperative outcome. Therefore, the aim of this study is to develop a new instrument, which the investigators call condylar redactor, to assist the surgeon to reduct the condylar segments effectively.

In this prospective cohort study, it involved condylar fractures patients who were received surgical treatment from January 2014 to June 2016. Patients in the experimental group were treated with the condylar reductor, and patients in the control group were treated with the traditional surgical instruments. The primary outcome variable was reduction time and reduction rate. The continuity correction X2 and test student t test were used.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18-60 with mandibular condylar fractures were treated in Oral and maxillofacial surgery department, West China hospital of stomatology, China from January 2014 to January 2016.

Exclusion Criteria:

* patients refused to participate in the clinical trial;
* condylar fracture dislocation was not obvious, conservative treatment can be used;
* mandibular condylar comminuted fracture;
* mandibular condyle need to be reconstructed.
Probiotics Combined with Enteral Nutrition Reduces Postoperative Infectious Complications in PD

Probiotics combined with enteral nutrition reduces postoperative infectious complications in PD


Eligibility Criteria:
Inclusion Criteria:

* Adult patients greater than 18 years of age;
* Indication for elective pancreaticoduodenal surgery;
* Patients who understand the nature of the trial and are willing and able to provide written consent

Exclusion Criteria:

. Current or recent (within the previous 1 month) use of probiotic-based products or antibiotic therapy medications.

Inability to tolerate PD due to cardiopulmonary function and other parameters

* Received radiotherapy before surgery
* Emergency PD surgery
* Pregnant and breastfeeding women
Quality of Life and Treatment Satisfaction in β-Thalassemia Patients Receiving Deferasirox

Regular blood transfusions are essential for the management of haematological conditions such as β-thalassemia major. As a result, however, patients with these conditions are susceptible to the development of transfusion-dependent iron overload (hemosiderosis or secondary iron overload

In the absence of a naturally occurring physiological mechanism for the removal of excess iron in the body, life-long treatment and adherence to iron chelation therapy (ICT) are necessary to prevent the morbidity and mortality that may result if excess iron is allowed to .

Deferasirox (DFO),is the oldest available form of ICT used by patients with transfusion-dependent disorders. Improvements in ICT administration convenience and tolerability are expected to improve patient's satisfaction with ICT and Health Related Quality of Life (HRQOL), thus promoting adherence to ICT regimens and potentially reducing iron overload-related morbidity/mortality and associated healthcare costs

Eligibility Criteria:
Inclusion Criteria:

1 - Age more than 16 years 2-transfusion related iron over load (serum ferritin more than 1000 ng/ml) 3-patients on oral iron chelation (deferasirox ) for one year or more

Exclusion

1. primary haemochromatosis
2. thalassemia minor patients
3. preseance of systemic disease that prevent patient from treatment ,
Mortality and Neurologic Outcomes in Rapid vs. Slow Hyponatremia Correction

This study examines the impact of different rates of sodium correction on the outcomes of patients with severe hyponatremia (serum sodium ≤ 120 mEq/L). Hyponatremia is a condition where blood sodium levels are dangerously low, and its treatment must be carefully managed to avoid complications. Standard guidelines recommend correcting sodium levels slowly to prevent a rare but serious neurological condition called osmotic demyelination syndrome (ODS). However, recent evidence suggests that a faster rate of sodium correction may reduce hospital stay length and mortality without increasing the risk of ODS.

This retrospective study, conducted from 2010 to 2023 at a hospital in Buenos Aires, Argentina. It compares the outcomes of patients who had their sodium levels corrected rapidly (≥ 8 mEq/L in 24 hours) to those who had slower corrections. The primary outcomes measured are mortality and the development of ODS.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older.
* First hospitalization at Hospital Italiano de Buenos Aires with a serum sodium (natremia) level ≤ 120 mEq/L at admission.

Exclusion Criteria:

* Absence of serum sodium values after the first 24 hours of hospitalization.
* Hospitalizations shorter than 24 hours.
* Patients with previous hospitalizations prior to the study period where admission serum sodium levels were ≤ 120 mEq/L.
Does Vestibular System Effected in Chronic Obstructive Pulmonary Disease Patients

. The main question is whether the vestibular system is affected by COPD. If there is an influence, the second question is what is the relationship between balance and vestibular interaction in COPD patients. A total of 10 COPD patients and 10 healthy adults will include the study. Respiratory functions, vestibular functions and postural stability of participants will be assessed. This research is planned to be carried out as a cross-sectional/descriptive research. It's planned as a pilot study. Comparisons between study and control groups will be made with independent samples t-test for parametric values and Mann Whitney U for non-parametric values.

Chronic Obstructive Pulmonary Disorder (COPD) is a common preventable and treatable disease that is characterized by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. Hypoxia caused by restrictive airflow is one of the symptoms of COPD. Hypoxia can affect the inner ear and vestibular nuclei. Also, balance impairment can be caused by hypoxia. Previous studies show that balance affected negatively in COPD patients. The aim of this study is to investigate of vestibular system influence in individuals with COPD. A total of 10 COPD patients and 10 healthy adults will include the study. This research is planned to be carried out as a cross-sectional/descriptive research. It's planned as a pilot study. Respiratory functions (respiratory function test), vestibular functions (head shake test, head trust test, unterberger test) and postural stability (sensory organization test) of participants will be assessed.Comparisons between study and control groups will be made with independent samples t-test for parametric values and Mann Whitney U for non-parametric values.

Eligibility Criteria:
For study group

Inclusion Criteria:

* Volunteering to participate in the study
* Diagnosed with COPD

Exclusion Criteria:

* Communication - Coordination problems of patients
* Using medicine which is increasing the risk of fall
* Any neurologic or musculoskeletal disorders which affect mobility and balance
* Loss of hearing

For control group

Inclusion Criteria:

* Volunteering to participate in the study

Exclusion Criteria:

* Communication - Coordination problems of patients
* Using medicine which is increasing the risk of fall
* Any neurologic, musculoskeletal or respiratory disorders which affect mobility and balance
* Loss of hearing
DDI Study to Investigate the Impact of Itraconazole on the Pharmacokinetics of Dorzagliatin

The purpose of this study is to investigate the impact of itraconzaole on the pharmacokinetics of Dorzagliatin.


Eligibility Criteria:
Inclusion Criteria:

* Age 30-65
* Body weight ≥ 50 kg
* BMI ≥ 19.0 kg/m2 and ≤ 30.0 kg/m2
* HbA1c ≥ 7% and ≤ 10.5%
* FPG ≥ 7.5 mmol/L and ≤ 13.3 mmol/L

Exclusion Criteria:

* T1DM
* Use of prescription or OTC medications, and herbal within 14 days prior to dosing
* Blood donation
* Any surgery or treatment that may impact the ADME of the drug
Evaluation of Breathing, Sleep and the Effects of Continuous Positive Airway Pressure During Wakefulness in Children With Heart Failure

Adult patients with heart failure (HF) have an increased work of breathing and are at increased risk for obstructive and/or central apnea during sleep. Noninvasive continuous positive airway pressure (CPAP) has proved its efficacy in decreasing the work of breathing and improving sleep-disordered breathing in these patients.

The aim of the study is to analyze the work of breathing and objective and subjective sleep quality in children with HF and to evaluate the ability of noninvasive CPAP to decrease the work of breathing and improve cardiac output during wakefulness.

The study starts with the measurement during wakefulness of

* the breathing pattern and work of breathing
* and cardiac function during 5 min after 10 min of stable and calm spontaneous breathing (SB) Then the same measurement are made during 5 min after 10 min of stable and calm breathing during non-invasive CPAP Then a third measurement is made of
* the breathing pattern and work of breathing
* and cardiac function during 5 min after 10 min a stable and calm SB

Polysomnography is then performed during the following night during SB in order to assess objective sleep quality.

Subjective sleep quality is assessed on the following morning in children \> 6 years of age by validated sleep questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* A child with HF and having:
* Dilated cardiomyopathy with an ejection fraction \<45%
* Univentricular congenital heart disease
* Left ventricular valvulopathy
* Age 8 months to 17 years
* Signed informed consent by the owner (s) of parental authority and investigator
* Patient affiliated to a social security scheme or entitled (excluding MEAs)
* Comparison of results depending on the status T21 / T21 not.

Exclusion Criteria:

* HF with use of inotropic drugs during the last 30 days.
* Contra indication to CPAP or inability to maintain the airway or adequately remove phlegm, risk of aspiration of gastric contents, acute sinusitis or diagnosis of otitis media, epistaxis, hypotension.
* Associated pathology may be responsible alone an obstructive apnea (ENT or maxillofacial malformation pathology, abnormalities of the upper airway, obesity with BMI z-score\> 2), a central apnea syndrome (Chiari malformation), or alveolar hypoventilation (neuromuscular disease, cystic fibrosis or bronchopulmonary dysplasia).
HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer

The purpose of this study is to determine the safety and immunogenicity of HER-2 pulsed DC1 vaccine in high risk HER-2 high and intermediate expression breast cancers. Participants will have HER-2 driven IBC at least Stage IIIA with N2 following chemotherapy with/without trastuzumab or recurrence exclusive of new primary tumor but rendered NED. Mammogram, laboratory studies, CT, and leukapheresis will be performed, in addition to vaccine administration.

Dendritic cell cancer vaccines combined with chemotherapy may increase complete responses giving breast cancer specific immune cells greater opportunity to function while the immune repertoire is being shifted by chemotherapy to anti-breast cancer response and offer the chance to test secondary prevention of breast cancer in high risk settings. Participants with HER-2 driven IBC at least Stage IIIA with N2 (4 positive nodes) following chemotherapy with or without trastuzumab or those with recurrence exclusive of new primary tumor but rendered NED will be undergo mammograms, laboratory studies, and leukapheresis. Vaccines will be manufactured using participants' leukapheresis product, which will be administered in the Clinical Research Center 1 Dulles Building weekly for 6 weeks. Three booster vaccines will be administered at 3 month intervals following the initial induction vaccines. Immune analysis will be done after participant receives all induction vaccines and again after they receive all booster vaccines.

This study began at the Abramson Cancer Center of the University of Pennsylvania and will be continued at H. Lee Moffitt Cancer Center and Research Institute.

Eligibility Criteria:
Inclusion Criteria:

* Women over Age 18 years.
* Potential participants with Invasive Breast Cancer at least Stage IIIA, greater than or equal to N2 (\>4 positive nodes) or have recurrent metastatic breast cancer rendered NED by any means that are classic HER-2 3+ 30%, 2+ IHC and FISH positive or HER-2 2+ FISH negative, that have completed chemotherapy and/or trastuzumab and are within 1 year from their last treatment and have no evidence of disease.
* Deemed to require anti-estrogen therapy for treatment of their breast cancer can continue anti-estrogen therapy during vaccinations.
* Women of childbearing age with a negative pregnancy test documented prior to enrollment.
* Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
* Willing to use birth control if necessary.
* Have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them.

Exclusion Criteria:

* Pregnant or lactating.
* Positive for positive HIV or hepatitis C at baseline.
* Patients with coagulopathies, including thrombocytopenia with platelet count less than 75,000, INR greater than 1.5 and partial thromboplastin time greater than 50 sec.
* Major cardiac illness MUGA less than 50% EF.
* Pre-existing medical illnesses or medications which might interfere with the study as determined by Principal Investigator (PI).
Topical Intra-Oral Ketoprofen for Migraine Prevention

Intra-Oral Topical Ketoprofen gel, applied to a branch of the trigeminal nerve, has been shown to prevent migraines when used once daily for 3 months in open label studies. This is a randomized, double-blind, placebo controlled phase III prevention trial to determine safety and efficacy.

This is a 4 month trial. During the first month, a prospective headache diary is maintained. Migraine frequency, severity (1-10), duration, and all headache medications are recorded.

Patients are then randomized to receive active gel or placebo gel in double blind fashion.

Gel is applied to the posterior maxilla once daily for 3 months. A daily headache diary, as outlined above, is maintained throughout the trial. Patients may continue to take other migraine medications, as needed. No other new migraine therapies may be started during the trial.

Eligibility Criteria:
Inclusion Criteria:

* IHS Migraine with or without aura
* 18 y.o. or older
* at least 4 migraines per month

Exclusion Criteria:

* pregnancy
* other headache conditions
* chronic daily headache
* allergy or sensitivity to NSAIDs other severe illnesses
Stress and Mental Ill-health in the Workplace: Evaluation of an Intervention for the Prevention of Sick Leave

Purpose

Common mental disorders (CMD:s) are the leading cause of sick-leave spells in Sweden, resulting in suffering for the individual and financial costs for the employer as well as for society at large. Studies on interventions that address stress and mental ill-health and that focus on sick leave and return to work (RTW) show little or no effect of commonly used methods such as medication or psychological approaches. Furthermore, these interventions often focus on the individual's symptoms without considering their work situation. The occupational health services (OHS) has knowledge of the employee's work environment and can offer treatment facilitating the employee's RTW and improving the employee's work ability while taking into account both the individual and the work situation. The intervention in the current study will be performed at the OHS.

The study aim is two-fold: first, an intervention that addresses both individual and workplace related aspects among employees with work-related CMD:s and/or stress related symptoms will be evaluated. In particular, the treatment's cost-effectiveness and impact on sick leave and mental health will be studied. Secondly, the concerned OHS staff's adherence to the intended treatment and associations with the outcome of the intervention will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* The employee suffers from stress related symptoms or work-related common mental disorders.
* The employee is either not on sick leave or is on sick leave for a maximum of 3 consecutive months (full or part time).
* The employee understands both written and spoken Swedish.
* The employees nearest supervisor should be aware of the employees visit(s) at the OHS (to avoid differential selection into the experimental and the control condition)

Exclusion Criteria:

* Bullying
* Pregnancy
* Post traumatic stress-disorder
* Severe mental disorders (e.g. psychosis)
* Any co-morbidity that may substantially affect the employee's ability to work and/or quality of life.