cyrilzakka/clinical-trials huggingface dataset:
The Effect of Post-discharge educatıon provıded vıa Tele-nursıng to Elderly patıents

Purpose: The aim of this study is to evaluate the effect of post-discharge training given via tele-nursing to elderly patients operated for hip fracture on the quality of life and functional independence levels of the patients.

Materials and Methods: This randomized controlled, pretest-posttest, single-center experimental study was conducted in a hospital between August 2022 and April 2023, with 30 patients in the intervention group and 30 patients in the control group. Nursing intervention was administered to the intervention group by three educational online video calls (1st, 2nd and 3rd weeks after discharge), three educational voice phone calls (4th, 5th and 6th weeks after discharge) and It consists of a training booklet with educational content. No intervention was applied to the control group. Research data; It was collected using the Patient Introduction Form, SF-36, FIM. Informed consent was obtained from the patients and caregivers with the permission of the ethics committee and the institution. Data analysis was done using Chi-Square, Independent T-Test and Dependent T-Test.

Eligibility Criteria:
Inclusion Criteria:

* Being 65 years or older
* Being hospitalized and operated on with a diagnosis of hip fracture as a result of a simple fall/falling from one's own level/osteoporotic fracture
* Being literate
* Not having a visual/hearing disability that would hinder communication.
* Not having a Mental Disorder (According to the statements of the patients)
* Having a primary caregiver aged 18 and over who will cooperate throughout the research,
* Having any of the available technical equipment that allows online calls (Phone, tablet, computer, etc.).

Exclusion Criteria:

* • Having previously broken a hip and been operated on

  * Being bedridden or using walking aids before the current fracture
Dose-Ranging Study Evaluating AVE1625 in Abdominally Obese Patients With Atherogenic Dyslipidemia

Primary objective: to assess the effect of AVE1625 on weight loss over a period of 24 weeks in abdominally obese patients with atherogenic dyslipidemia. Secondary objectives: - To assess the dose effect relationship of AVE1625 on HDL-cholesterol and triglycerides plasma levels over a period of 24 weeks - To assess the efficacy of AVE1625 on secondary parameters such as waist circumference and other metabolic parameters over a period of 24 weeks - To assess the safety and tolerabillity of AVE1625 over a period of 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Abdominal obese patients with ·
* Waist circumference \> 102 cm in men and \>88 cm in women
* Dyslipidemia consisting of :

  * Triglycerides ≥ 1.50 g/L (i.e 1.69 mmol/L) and ≤ 7.0 g/L(i.e. 7.90 mmol/L)AND/OR
  * HDL-cholesterol \< 50 mg/dL (i.e. 1.29 mmol/L) in women and \< 40 mg/dL (i.e. 1.04 mmol/L) in men

Exclusion Criteria:

* Pregnancy or lactation
* Women of child-bearing potential with no medically approved contraception
* Patients with type 1 diabetes
* Patients with type 2 diabetes must be on a stable dose of oral antidiabetic drugs (excluding glitazones, exenatide, sulfonylurea and nateglinide) and should not receive insulin therapy
* Patients with any clinically significant endocrine disease
* Patients on anticoagulants (heparin, warfarin) or with bleeding disorders
* Clinically relevant disease interfering with subject's safety or making implementation of the study protocol or interpretation of study results difficult
* Patients with mental retardation or any clinically significant psychiatric disorder
* History or concurrent substance abuse (other than nicotine or caffeine especially marijuana or hashish)
* Chronic systemic corticotherapy
* Patients with weight change \> 5kg within 3 months prior to screening
* Patients should not have received anti-obesity drugs or other drugs for weight reduction in the 3 months prior to screening.
* The investigator will evaluate whether there are other reasons why a patient may not participate
Intervention Effect of Transcranial Alternating Current Stimulation(tACS) on Anxiety Disorder

To investigate the intervention effect of transcranial alternating current stimulation(tACS) on anxiety symptoms and somatic symptoms in patients with anxiety disorder and its underlying neural mechanism by MRI.

Forty patients with anxiety disorder diagnosed by DSM-5 were recruited from the second affiliated Hospital of Anhui Medical University. All participants underwent a structured interview and routine laboratory examination before and after receiving tACS. After meeting the inclusion criteria and obtaining informed consent, each participant will complete the clinical evaluation, functional magnetic resonance imaging (fMRI) and tACS treatment conducted by trained researchers at the Neuropsychological Synergetic Innovation Center of Anhui Medical University. All the participants were randomized (1:1) to receive "active" or "sham" treatment protocol. The anode was placed over AF3 with return electrodes placed at the contralateral mastoid process. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes per session, twice daily over 7 consecutive days, and the stimulus frequency was set as 8 Hz. Sham tACS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.

Before and after the tACS treatment, the patients had receiving a battery measure of neuropsychological tests and Magnetic resonance imaging scan in multimodalities. Neuropsychological assessment included HAMD, HAMA, PHQ15, ISI, ASI, SAS, RRS, IUS. Multimodal fMRI includes 3D-T1, rs-fMRI and DTI.

Neuropsychological evaluation and magnetic resonance imaging data were obtained again 24 hours after the last treatment. The symptoms of the patients were followed up one month after the end of treatment.They were instructed to focus their answers on the past week. Afterwards, they were unblinded by the study coordinator.

Eligibility Criteria:
Inclusion Criteria:

* the patients were diagnosed by more than 2 psychiatrists and met the diagnostic criteria of DSM-5 for anxiety, and HAMA\>14, PHQ-15\>5.

the age ranged from 18 to 60 years old, and the length of education was more than 5 years.

the visual acuity or corrected visual acuity is normal, right-handed, can cooperate with the completion of various experimental tests.

Exclusion Criteria:

* accompanied by severe somatic diseases, such as severe heart, liver, renal insufficiency and so on.

accompanied by other neurological diseases, such as stroke, epilepsy and so on. pregnant and lactating women. accompanied by other mental disorders, such as drug abuse, schizophrenia, schizophrenic affective disorder, hysteria, autism and so on.

patients with MRI taboos or factors affecting imaging quality, such as cardiac pacemaker, cochlear implant, cardio-cerebrovascular metal stent, metal denture, etc.

those who could not cooperate with those who completed the relevant experiments, such as patients with depressive stupor, claustrophobia and so on.
Dose Tolerance Study After Ocular Administration of Tiotropium in Healthy Male Volunteers

Safety and tolerability after ocular administration


Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* Age range from 21 to 50 years
* Within ± 20% of normal weight (Broca-Index)
* Written informed consent given

Exclusion Criteria:

* Results of the medical examinations or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
* Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Volunteers with disease of the central nervous system (such as epilepsy) or with psychiatric disorders
* Volunteers with known history of orthostatic hypotension, fainting spells or blackouts
* Volunteers with chronic or relevant acute infections
* Volunteers with history of allergy/ hypersensitivity (including drug allergy)
* Volunteers with known eye diseases (incl. glaucoma), with hyperopia (\> 3 diopters) or with contact lenses
* Volunteers with intraocular pressure \> 22 mmHg
* Volunteers with predisposition to narrow-angle glaucoma
* Volunteers with disturbed micturition
* Volunteers who have taken a drug with a long half-life (≥ 24 hours) within ten half-lives of the respective drug before enrolment in the study
* Volunteers who received any other drugs which might influence the results of the trial during the week previous the start of the study
* Volunteers who have participated in another study with an investigational drug within the last two months preceding this study
* Volunteers who smoke (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Volunteers who are not able to refrain from smoking on study day
* Volunteers who drink more than 40 g of alcohol per day
* Volunteers who are dependent on drugs
* Volunteers who have donated blood (≥ 100 ml) within the last four weeks
* Volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis

International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis


Eligibility Criteria:
Inclusion Criteria:

Male and female subjects aged 18 to 55 years with established diagnosis of MS McDonald 2010 with relapsing course from onset (i.e., RRMS and SPMS with superimposed relapses).

Subjects must have active disease evidenced by one or more MS attacks with onset within the period of 12 to 1 months prior to randomization, or by two or more MS attacks with onset within the 24 to 1 months prior to randomization, or with one or more gadolinium-enhancing (Gd+) lesion(s) of the brain on an MRI performed within 6 months prior to randomization.

Enrolled subjects must be ambulatory (EDSS score of up to 5.5 inclusive) and may be treatment-naïve or previously treated with MS disease modifying therapy.

Exclusion Criteria:

Subjects with significant medical conditions or therapies for such conditions (e.g., cardiovascular, pulmonary, immunological, hepatic,ophthalmological conditions) or lactating or pregnant women are not eligible to enter the study.

Subjects with contraindications to MRI or with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study are not eligible to enter the study.
Confocal Microscopy of Benign and Malignant Skin Tumors

The investigators speculate that this tool may be used as an alternative and convenient non-invasive diagnostic of skin cancer.


Eligibility Criteria:
Inclusion Criteria:

* Men and women over the age of 18
* Skin lesion suspected to either BCC or SCC etc
* Patient was referred for biopsy diagnostic/therapeutic before hand, and regardless of confocal microscope examination, according to the clinical consideration of physician

Exclusion Criteria:

* Pregnant women
* Children
Pazufloxacin Mesilate Ear Drops Clinical Trial Protocol

To investigate the safety, tolerance, dynamic percolation model of single dose usage pazufloxacin mesilate ear drops for patients with acute suppurative otitis media or chronic suppurative otitis media


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-65 years old, both gender;
2. Patients with acute or chronic suppurative otitis media, need to be treated partially by antimicrobial agents;
3. Written informed consent form.

Exclusion Criteria:

1. Allergic to quinolones antibiotics or severe allergic constitution;
2. Not able to collect otorrhea during the trial;
3. High severity with the need of combined antibiotics treatment;
4. Induced by pathogens, e.g.: fungus, virus (myringitis bullosa);
5. Combined otitis externa (e.g.: ear cellulitis, mumps), intracranial or extracranial complication (meningitis, cerebral abscess, thrombophlebitis of sigmoid sinus, Bezold's abscess, ear subperiosteal abscess);
6. Severe disease of cerebral, cardiopulmonary, renal hepatic, circulatory system;
7. Life-threatening disease, e.g.: malignant tumor or AIDS.
8. Renal hepatic dysfunction (ALT, AST ≥ 1.5 times of normal maximum level, Cr \> normal maximum level);
9. Confirmed or suspected of alcohol/drug abuse record;
10. Neurological or psychiatric disease leading to inability of cooperation or not willing to follow the protocol or instruction;
11. Feminine patients who are in gestational, lactation period or having a birth plan in short-term;
12. Enrolled into other clinical trial in the past 3 months;
13. Not suitable for this trial according to investigator's judgment;
Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction

This is a double-blind, randomized, parallel group, dose ranging study of subcutaneous methylnaltrexone to be conducted in patients with advanced medical illness and poorly controlled opioid induced constipation. Patients will be randomized to one of three fixed dose levels of SC MNTX.


Eligibility Criteria:
Inclusion Criteria:

1. Must have advanced medical illness (cancer, HIV, etc) and be receiving palliative care
2. Must be on opioid medication for at least 2 weeks with no expectation of significant change in regimen
3. Must have constipation
4. Must be 18 yrs or older

Exclusion Criteria:

1. Concurrent use of medications other than opioids which might interfere with gastrointestinal motility
2. Patients who received any experimental drug in the last 30 days
3. Patients with active peritoneal cancer (ovarian, etc.)
4. Patients with active diverticulitis or diverticulosis
High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure for Respiratory Support of Preterm Neonates

This work is designed to:

1. Evaluate the efficacy of HHHFNC in comparison with nCPAP in preterm neonates.
2. Investigate hemodynamic changes associated with HHHFNC in comparison to nCPAP in preterm neonates during periods of non-invasive respiratory support and after being off support.

There is a preference of using noninvasive modes of ventilation for management of respiratory distress syndrome (RDS) in preterm infants and of weaning of ventilated neonates as soon as possible to non-invasive modes.

Yet, little is known about which non-invasive mode is better and the hemodynamic changes that occur to the infants secondary to these modes. The study provides an evaluation of the efficacy of heated, humidified high flow nasal cannula (HHHFNC) in comparison to nasal continuous positive airway pressure (nCPAP) in preterm infants. Secondary aim is to assess echographic, cerebral blood flow and mesenteric blood flow changes during HHHFNC versus nCPAP.

Eligibility Criteria:
Inclusion Criteria:

Infants are eligible if they meet the following criteria:

1. Gestational age ≤ 35 weeks.
2. Preterm neonates in need for non invasive ventilation whether they were on invasive ventilatory support before or not.

Exclusion Criteria:

Preterm neonates with evidence of any of the following will be excluded:

1. Major upper or lower airway anomalies.
2. Significant congenital anomalies including cardiac, abdominal or respiratory.
3. Hemodynamically significant patent ductus arteriosus (PDA): diagnosed if there is colour doppler echocardiographic evidence of left to right ductal shunt, ductal diameter \>1.5mm/kg or left atrial/aortic root ratio \>1.4
Efficacy of Compound Betamethasone Injection Combined With Ropivacaine in Ultrasound-guided Thoracic Paravertebral Nerve Block for Chronic Post-thoracotomy Pain

Chronic post-thoracotomy pain（CPTP）will not only have a negative impact on patients' physiology and psychology, but also affect postoperative recovery.A number of researches have demonstrated that Injury to the intercostal nerve during surgery predominantly accounts for the onset of CPTP.It is closely related to postoperative local acute inflammation and neuroinflammation. Thoracic paravertebral block (TPVB)has become a new trend for post-thoracotomy pain management.Glucocorticoids,as a adjuvant, are reported to prolong the effects of local anesthetic for peripheral nerve blocks.Diprospan is a long-acting glucocorticoid. It has been widely used in clinical treatment of various pain syndromes for powerful analgesic and anti-inflammatory effects. At present, most clinical reports are limited to the acute postoperative period, and there are few studies focusing on the long-term postoperative analgesic effect of diprospan.Therefore, it is reasonable for us to hypothesise diprospan, as a longer-acting glucocorticoid, can provide more lasting analgesic effects,or even reduce the incidence of CPTP

PARAVERTEBRAL BLOCK (PVB) involves the injection of local anesthetic (LA) into a wedge-shaped space lateral to the spinal nerves as they emerge from the intervertebral foramina, producing ipsilateral somatosensory and sympathetic nerve blockade.Since its initial application in abdominal surgery, the technique has been adapted for rib fracture, flflail chest, open cholecystectomy, hepatic-biliary surgery, outpatient inguinal hernia repair, major breast cancer surgery, and open thoracotomy patient populations.Based on several recent systematic reviews and metaanalyses,TPVB and TEA are equal in analgesic effect after thoracic surgery. Moreover, TPVB is associated with fewer side effects,such as urinary retention,nausea/vomiting,pruritus and hypotension. It can also be used for patients with coagulation disorders. Kang et al. argued that TPVB can significantly improve postoperative rehabilitation in patients undergoing thoracoscopic radical lung cancer surgery .

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-70 years
2. American Society of Anesthesiologists(ASA) physical status of I-III
3. BMI: 18.5-28 kg/m2
4. Type of operation: elective thoracoscopic lobectomy
5. The patient and/or family members have signed the informed consent -

Exclusion Criteria:

1. Allergic to local anesthetics or glucocorticoids
2. Preoperative use of opioids
3. Severe coagulation dysfunction
4. Severe heart, lung, liver and kidney insufficiency
5. Used to have immunosuppressive therapies such as radiotherapy, chemotherapy and glucocorticoid, or have immune system diseases
6. Peptic ulcer
7. Perform astrointestinal anastomosis recently
8. Used to have a chest surgery
9. Central nervous system disease or peripheral neuropathy
10. Perioperative blood transfusion
11. Others: such as fracture, wound repair, corneal ulcer, adrenal hypercortical disease, diabetes, pregnant women -
Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1, Seasonal Influenza Vaccine, Formulation 2009-2010

This is a trial for annual registration of the updated seasonal influenza vaccine formulation.


Eligibility Criteria:
Key Inclusion Criteria:

* Subjects of 65 years of age or older
* Mentally competent
* Willing and able to give written informed consent prior to study entry
* Able to comply with all the study requirements
* In general good health

Key Exclusion Criteria:

* Any serious chronic or acute disease disease
* History of any anaphylactic reaction and/or serious allergic reaction following a vaccination
* A proven hypersensitivity to any component of the study vaccine
* Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age)
* Bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
* Within the past 12 months, participants had received more than one injection of influenza vaccine
* Within the past 6 months, participants had laboratory confirmed influenza disease or received influenza vaccine
Molecular Imaging of HER2 Expression in Breast Cancer Using [123I] I-(HE)3-G3

The study should evaluate distribution of \[123I\] I-(HE)3-G3 in patients with primary HER2-positive and HER2-negative breast cancer

Overall goal of the project: To determine HER2 expression level in primary breast cancer before neoadjuvant system therapy.

Phase I. Distribution of HE3-G3 (\[123I\] I-(HE)3-G3) in patients with primary breast cancer. The study should evaluate distribution of HE3-G3 (\[123I\] I-(HE)3-G3) in patients with primary HER2-positive and HER2-negative breast cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is \> 18 years of age
2. Availability of results from HER2 status previously determined on material from the primary tumor and metastatic LN, either a. HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or b. HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative
3. Hematological, liver and renal function test results within the following limits:

   * White blood cell count: \> 2.0 x 109/L
   * Hemoglobin: \> 80 g/L
   * Platelets: \> 50.0 x 109/L
   * ALT, ALP, AST: =\< 5.0 times Upper Limit of Normal
   * Bilirubin =\< 2.0 times Upper Limit of Normal
   * Serum creatinine: Within Normal Limits
4. A negative pregnancy test for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination
5. Subject is capable to undergo the diagnostic investigations to be performed in the study
6. Informed consent

Exclusion Criteria:

1. Any system therapy (chemo-/targeted therapy)
2. Second, non-breast malignancy
3. Active current autoimmune disease or history of autoimmune disease
4. Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) 4. Known HIV positive or chronically active hepatitis B or C
5. Administration of other investigational medicinal product within 30 days of screening
6. Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
Gas Embolism With Use of Argon Plasma Coagulation

The purpose of this study is to use transesophageal echocardiography (TEE) to determine the incidence, severity, and clinical significance of gas bubbles during argon plasma coagulation (APC).

Gas embolism is a rare but serious complication of APC. We will use TEE to monitor for gas bubbles during APC. APC will be terminated if gas bubbles are associated with ischemic heart rhythms, wall motion abnormalities, or if large gas bubbles are noted in the left ventricle.

Eligibility Criteria:
Inclusion Criteria:

* Adults (male and female) 18 years of age or older
* Clinical indication for bronchoscopy (hemoptysis, airway obstruction, tumor excision, granulation tissue that is impairing endobronchial stent performance)
* Ability of the patient or proxy to read, comprehend, and sign informed consent document.

Exclusion Criteria:

* Presence of esophageal disorders that may complicate transesophageal echocardiography (strictures, varices, fistula, prior esophageal surgery)
* Presence of coagulopathy or other bleeding diathesis
* Inability to tolerate brief periods of apnea
* Presence of pulmonary vascular disease
* Pregnant women will not be included in this study because the potential fetal hypoxemia is not an acceptable risk.
* No exclusions will be made based on gender or race.