cyrilzakka/clinical-trials huggingface dataset:
Tropisetron on Postoperative Pain

The role of 5-HT3A receptors in nociceptive processing has been demonstrated in several animal models. However, studies in human volunteers have not been reported except for one recent study suggesting that ondansetron could alleviate propofol-induced nociception. Previous studies demonstrated that patients anaesthetized with sevoflurane have more pain than those anaesthetized with propofol. And we further posit that the difference is due to the nociceptive processing induced by the action of 5-HT3A receptors.

In this prospective, randomized, double-blind, placebo-controlled study, we assessed the analgesic action of a 5-HT3A receptor antagonist (tropisetron) in women after gynaecological laparoscopy under general anaesthesia maintained with either sevoflurane or propofol.


Eligibility Criteria:
Inclusion Criteria:

* female patients
* American Society of Anaesthesiologists Physical Status (ASA-PS) I or II
* undergoing selective gynaecological laparoscopies for infertilities

Exclusion Criteria:

* aged under 18 years old
* body mass index (BMI) \> 30
* history of cardiovascular disease
* history of respiratory disease
* history of neurologic disease
* history of chronic antidepressants
* history of anxiolytics
* history of chronic analgesics intake
* participating in other studies
Effectiveness of Early Parent-Based Language Intervention

The purpose of the study is to examine the effectiveness of a highly-structured parent-based language intervention group program for two-year-old children with language delay.

Language delay in toddlers is a prevalent problem for pediatric practitioners. As there are no clear guidelines to deal with this problem, in German speaking countries the "wait-and-see"approach is widely chosen, although longitudinal studies have found that children with language delay are at risc for cognitive, behavioral and social-emotional problems.

During the last few years various forms of early language intervention have been increasingly implemented in German speaking countries. However, they have not been evaluated.

Early parent-based intervention could be an economical way in prevention speech and language disorders.

Eligibility Criteria:
Inclusion Criteria:

* Children with receptive and/or expressive language abilities below norm range measured by the standardized and norm-referenced German developmental language test SETK-2 (Grimm, 2000)

Exclusion Criteria:

* Children with visual impairments, genetic syndromes, metabolic diseases
* Children with previous language intervention
Effect and Safety of Propofol Fumarate for Mother-to-child Blocking of Hepatitis B

This study is a prospective study. The subject will select 440 cases of pregnant women with high hepatitis B virus load, and one group will take maternal and child blockade treatment with propofol fumarate. One group will take tenofovir disoproxil fumarate. Broken treatment, compare the failure rate of maternal and child blockade and the incidence of maternal and child adverse events in the two groups, and explore the efficacy and safety of propofol flavuril for the treatment of hepatitis B mother-infant block.

This study was a prospective cohort study. Because propofolofofovir is not covered by medical insurance and is more expensive, and there are factors such as renal function damage and the risk factors that can not use tenofovir, it is difficult to conduct randomized controlled cases. The subject will select 440 cases of pregnant women with high hepatitis B virus load. After signing the informed consent form, according to the patient's wishes, one group will take the mother-infant blockade of propofol fumarate, and one group will take fumaric acid. In the case of maternal and child blockade of benifovir, the incidence of maternal and child block failure and the incidence of maternal and child adverse events were compared between the two groups, and propofol fumarate was used for maternal and child blockade of hepatitis B. The effectiveness and safety of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* No nucleoside analog antiviral drugs have been used in the past.
* HBsAg and HBeAg double positive, HBV DNA\>106 IU/mL.
* Fully inform the risk to voluntarily join the study and sign the informed consent form.

Exclusion Criteria:

* Combine other viral infections: such as HCV, HIV, CMV, etc.;
* amniocentesis during pregnancy;
* Liver cirrhosis and liver cancer;
* Other autoimmune diseases and liver diseases;
* fetal ultrasound screening in early and middle pregnancy found deformity.
Digital Motivation to Decrease Inactive Behaviour in Patients With Knee Osteoarthritis

Physical inactivity is a major risk behaviour with a potential for causing premature death, particularly among people with mobility limitations, such as knee osteoarthritis.

Digital motivational interventions (such as SMS) can motive to a healthy behaviour including increased physical activity.

The purpose of this study is to investigate if motivational text messages following an exercise intervention to improve mobility limitations will change the physical activity level in patients with knee osteoarthritis.

This study is designed as pilot randomized controlled trial, with equal randomization (1:1). Eligible participants will be randomised into one of two groups (intervention or control) after completing their baseline measurements. The intervention group will receive weekly motivational text messages and the control group will not receive any attention from the study.


Eligibility Criteria:
Inclusion Criteria:

* Age ≤18
* Diagnosed with knee osteoarthritis
* Owner of a smart phone or tablet
* Have just finished an exercise program for knee osteoarthritis

Exclusion Criteria:

* Not able to read and understand Danish
* Any condition, which in the opinion of the investigator would put the subject at increased safety risk by participation, or otherwise make the subject unsuitable for this study.
Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype

This study tests the efficacy of an 8-week, Skype-based, group resiliency training intervention (The Relaxation Response Resiliency Program) for improving psychological stress in patients with Neurofibromatosis. A control group will receive a general health education curriculum. The investigators hypothesize that patients will improve on measures of psychological stress as a result of the resiliency program.

A substudy (Unique Protocol ID: 2013P002605b) has been approved to test this study on a sub-population: patients with NF2 who are hard of hearing.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. Can read and speak English at or above the 6th grade level
3. Diagnosis of neurofibromatosis type 1, neurofibromatosis type 2, or schwannomatosis

Exclusion Criteria:

1. Severe active or untreated major mental illness that would interfere with study participation, to be determined at the discretion of the study investigator (e.g. untreated psychosis or suicidality)
2. Recent (within past 3 months) change in antidepressant medication
3. Use of formal relaxation training (including past participation in a mind-body program), currently or in the past 6 months.
4. Unable or unwilling to sign the informed consent documents
5. Unable or unwilling to complete psychological assessments online via the REDCap system.
6. Unable or unwilling to participate in an intervention delivered via videoconferencing with Skype.
Development of Multimodal Fusion Warning System and Non-invasive Techniques for Early Alzheimer's Detection.

Developing and validating an early digitalized recognition device and multimodal warning model for Alzheimer's disease, and establishing a precision transcranial ultrasound stimulation intervention system.

1. Establishment of early digitalized recognition devices and multimodal warning models for AD: Participants undergo clinical assessments, and if they meet the inclusion criteria, their gender, age, MMSE, MoCA, CDR, GDS scores, as well as EEG ERP and MR data are collected. Eye-tracking analysis based on human-computer interaction perception technology, limb movement detection, and laser radar depth sensor fusion cognitive assessment are also performed simultaneously. After enrollment, follow-up assessments using scales (MMSE, MoCA, CDR, GDS, ADAS-cog, etc.) are conducted every six months, and EEG ERP and MR data are collected annually.
2. Construction of a precision transcranial ultrasound stimulation intervention system: Participants were randomly divided into true stimulation group and false stimulation group: true/false stimulation for 2 weeks, washout for 2 weeks, false/true stimulation for 2 weeks. After treatment, behavioral scale assessment, EEG ERP and multimodal MRI were performed to evaluate the therapeutic effect.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with MCI / AD
2. Between the ages of 55 and 80
3. No history of mental illness such as schizophrenia, severe anxiety and depression

Exclusion Criteria:

1. Consistent with Parkinson's disease, frontotemporal dementia, dementia with lewy bodies Or Huntington's disease diagnostic criteria
2. Dementia due to other causes (e.g. cerebrovascular disease, central nervous system trauma, tumors, infections, Metabolic diseases, normal stress hydrocephalus, folic acid or vitamin B12 deficiency, hypothyroidism, etc.)
3. Have aphasia,Disorders that affect cognitive assessment, such as disorders of consciousness
4. Have a history of epilepsy or take antiepileptic drugs
HIV Prevention Program for African American Teen Males

The purpose of this study is to test if sexual health interventions can reduce the incidence of STIs among African American teens (15 to 21 years old). By doing this study, we hope to help African American teens improve their condom use skills and encourage them to use condoms more frequently. If the number of STIs in this population can be decreased, the health of African American teen males will greatly improve. We also believe that sexual partners (typically African American teen females) will also benefit.

Based on the observation that African Americans are vastly more likely than their white and Hispanic counterparts to be infected by the human immunodeficiency virus (HIV), the Centers for Disease Control and Prevention (CDC) has termed AIDS a "health crisis" for African Americans and has called for a heightened national response to this glaring racial disparity. The crisis is especially dramatic in the Southern United States. Thus, the search for effective interventions tailored to this population is a national priority. This study expands upon a previous study conducted among young African American men. In the previous study we developed and tested the efficacy of a brief, clinic-based, program designed to interactively promote safer sex for African American men (18 to 29 years of age) engaging in sex with women. Adjusted findings from the previous study provided relatively robust support for program efficacy, with men who received the intervention program being about two-thirds less likely, than controls, to acquire an STI during a 6-month period. This study expands on the work performed in the previous study by developing and testing a version for younger African American males (i.e., teen males).

The purpose of this study is to test the efficacy of a brief, clinic-based and theory-guided, intervention designed to reduce STI incidence among African American teen (15 to 20 years old) males presenting themselves for STI testing.

Eligibility Criteria:
Inclusion Criteria:

* at least 15, but not more than 23 years of age
* attending the clinic for the expressed purpose of being tested for sexually transmitted infections
* engaging in penetrative sex (penile-vaginal or penile-anal) at least once in the past 2 months
* willingness to return for the two planned follow-up assessments

Exclusion Criteria:

* self-report of being HIV positive
Biomarkers of Angiogenesis for Response to Therapeutic Combination in Advanced or Metastatic Kidney Cancer

This is a multicenter, exploratory, prospective study to identify angiogenesis and immune-related biomarkers predictive of progression free survival in patients with metastatic or advanced renal cell carcinoma treated by a combination of immunotherapy and antiangiogenic.

Recently, the management of renal cell carcinoma has undergone major changes with the emergence of combined therapies associating tyrosine kinase inhibitors (TKI) and immune checkpoint inhibitors (ICI) as first line treatments. However, there are no criteria to guide the choice between the different combinations validated and or between ICI combinations. Angiogenesis and immunity are intimately linked and some markers related have could be interesting to predict the efficacy of these combinations. Angiogenesis and immunity are highly related. This link may lead to new biomarkers to be explored to predict the response to TKI + ICI therapy combinations. On this basis, the investigators propose to conduct an open-label exploratory, multicenter prospective trial to study the association between angiogenesis and immune markers and the effect of combined TKI+ICI treatments.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven advanced or metastatic renal carcinoma
* treated in first line with an ICI-ICI or ITK-ICI combination (following current recommendations at inclusion)

Exclusion Criteria:

* Previous systemic treatment for renal cell carcinoma
* Other cancer developed in the last 5 years except local forms apparently healed as basal cell cancer.
* Contraindication for ICI-ICI or TKI-ICI combinations recommended on 1st line
* Refusal to participate in the study
* No affiliation to a social security regime (beneficiary or entitled)
* Vulnerable patients as defined by french law (Public Heath Code sections L1121 -5 to L1121-8) :
* Major patient subjected to legal protection (guardianship, curatorship, protection of justice)
* Pregnant or breastfeeding woman
Observational Study of Rapid Sequence Intubation (RSI) Drug Delivery Using Intraosseous (IO) and Intravenous (IV) Access in Pediatric Patients

This study will evaluate using intraosseous vascular access and intravenous vascular access to give pediatric patients the necessary medications to perform rapid sequence intubation, for patients with airway difficulties.


Eligibility Criteria:
Inclusion Criteria:

* subjects requiring rapid sequence intubation for whom rocuronium is chosen as the paralytic agent.
* the operator chooses to place a peripheral intravenous or powered intraosseous catheter to permit rapid sequence intubation.

Exclusion Criteria:

* subjects in whom vascular access for rapid sequence intubation drug administration was established prior to arrival to the emergency department.
Relation Between Rectus Femoris Muscle Tension and Hamstring Strength and Activity in Healthy Sprinters

An open-label, single-group, control, pretest-posttest clinical trial is going to be conducted, with 16 healthy sprinters. Rectus femoris length and hamstring strength and electromyography is going to be assessed at baseline, after 10 minutes control and after an static rectus femoris stretching technique.

The main objective is to register if an increase in rectus femoris stretching Range of Motion, increases hamstring strength and activity due to their antagonic relationship and their relation with pelvic tilt.


Eligibility Criteria:
Inclusion criteria:

* The athletes recruited have to be under regular training and competition
* Free of any symptoms, at least 3 days training weekly for the last three years
* Give written consent

Exclusion criteria:

- Subjects who have suffered lower limb or back injuries during those last three years
Assessing 11C-Choline (11C-CH) PET to Distinguish True Tumor Progression From Pseudoprogression in High-grade Gliomas

This is a pilot study. The purpose of this study is to test if an imaging tracer, not approved by the FDA, called 11C-Choline (11C-CH) is useful for evaluating your type of cancer. This tracer is used to perform PET scans. The researchers want to see if the 11C-CH PET scan, using the study tracer 11C-CH, can improve upon the usual scans at diagnosing or monitoring your type of cancer.

In patients with high-grade gliomas, changes on standard MRI of the brain may reflect true tumor growth or inflammatory changes in response to treatment, called pseudo-progression. It is important to distinguish true tumor growth from inflammation since inflammation indicates the tumor is responding to treatment. With standard MRI, it is difficult to determine if changes following treatment are due to tumor growth or inflammation early on. Researchers hope to learn if the investigational tracer, 11C-CH, will be able to distinguish true tumor growth from inflammation more accurately than standard MRI or 18F-FDG PET scans.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient is able to provide written informed consent prior to study registration
* Histologically-confirmed high-grade glioma
* Completion of treatment with standard radiation (with or without concurrent therapy).
* Standard gadolinium-enhanced MRI changes that are considered indeterminate for tumor progression vs. treatment-related changes by the neuroradiologist or clinician within 24 weeks of completion of radiation.

Exclusion Criteria:

* Inability to undergo or cooperate with an MRI or PET scan (e.g., claustrophobia, metal implant)
* Renal insufficiency with recent (\<3 month old) creatinine \> 2.0 mg/dL
* Pregnant or nursing female
Development, Reliability and Validity of the Telerehabilitation Usability Questionnaire- TrUQ

Neurological diseases are central nervous system diseases that cause an increase in the level of disability and limitations in daily life. Multiple Sclerosis (MS), stroke, and Parkinson's Disease (PD) are among the most common apparent neurological diseases, and epidemiological studies show that their prevalence has increased over time worldwide. Although MS, stroke, and PD have different causes and neurological aspects, they generally cause motor, sensory, and/or cognitive impairments, leading to restriction of the individual's activities and participation. Today, physiotherapy and rehabilitation approaches together with optimal medical and surgical treatment are the cornerstones of treatment for these diseases. Recently, it has been stated that various telerehabilitation interventions in the field of physiotherapy and rehabilitation may be an additional option to the rehabilitation approaches applied in the clinic. On the other hand, It is important to evaluate the level of usability in expanding the usability of telerehabilitation services and determining the best telerehabilitation service. For this reason, there is a need for questionnaires investigating the satisfaction level of physiotherapy and rehabilitation applied through telerehabilitation.

Questionnaire items will be created in two stages. First, 5 experts will independently review the literature on "telerehabilitation" and "usability". In addition, these experts will be asked to create a pool of questions based on their experiences in telerehabilitation and by taking the opinions of patients receiving telerehabilitation about usability. Then, 5 experts will come together and obtain a single question pool containing the questions they deem important in their question pool. The second step will involve scaling the elements. In this study, scale items will be scored on a five-point Likert scale, ranging from 1, strongly disagree to 5, strongly agree. Then, it will be applied to a pilot group of 10 people and it will be evaluated whether the items prepared by the experts are understood by the patients. In line with the expert opinion and the result of the pilot study, the final version of the scale will be decided and applied to MS, PD, and stroke patients who make up the study group. Finally, the validity and reliability of the questionnaire will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily participate in research to accept
* Mini-Mental Test score more than or equal 24
* Previously receiving physical therapy through telerehabilitation

Exclusion Criteria:

* Any visual, hearing, and perception problems that may affect the answering the questionnaire items
Effect of Oily Fish Intake, Sex, Age, BMI, and APOE Genotype on Plasma Long Chain n-3 Fatty Acid Composition

The purpose of this study is to investigate the effect of habitual oily fish intake, sex, age, BMI, and APOE genotype on plasma long chain n-3 fatty acid composition.

The marine long chain n-3 polyunsaturated fatty acids (LC n-3 PUFAs) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are beneficial to cardiovascular and cognitive health and the concentration of EPA and DHA present in blood and tissue lipids is positively correlated with these effects.

As a result, national and global authorities recommend regular consumption of oily fish in order to provide approximately 500 mg EPA+DHA per day in a healthy population. However, the associations between EPA and DHA intake and blood and tissue status, and therefore physiological benefits, are highly variable and the factors influencing this heterogeneity are not well understood.

This study aims to investigate the effect of habitual oily fish intake as well as sex, age, BMI, and Apolipoprotein E (APOE) genotype on LC n-3 PUFA status in plasma phosphatidylcholine, non-esterified fatty acids, cholesteryl esters and triacylglycerols in order to obtain greater knowledge of the determinants of LC n-3 PUFA status with the potential to develop more robust, and perhaps subgroup specific, recommendations for EPA and DHA intake.

Eligibility Criteria:
Exclusion Criteria:

* Diagnosed endocrine dysfunction including diabetes
* Fasting glucose concentration \> 6.5 mmol/L
* Myocardial infarction in the previous 2 years
* The use of medication that may interfere with lipid metabolism
* Fasting total cholesterol of \> 8.0 mmol/L
* TG of \> 3.0 mmol/L
* Currently following a weight loss diet
* Taking n-3 fatty acid supplements
First in Human SAD and MAD Study of Inhaled TD-0903, a Potential Treatment for ALI Associated With COVID-19

This is a phase 1 study in healthy subjects to evaluate the safety, tolerability and pharmacokinetics of single (Part A and B) and multiple (Part B) doses of inhaled TD-0903.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening and weighs at least 50 kg.
* Medically healthy with no clinically significant medical history, physical examination, spirometry, vital signs or ECGs.
* Forced expiratory volume in 1 second (FEV1) ≥80%.
* No clinically significant abnormalities in the results of laboratory evaluations.
* Female subjects must be either of non-childbearing potential or if of childbearing potential, subject must not be pregnant or breastfeeding, and must agree to use a highly effective birth control method.
* Male subjects must agree to use condoms, in addition to the use of highly effective pregnancy prevention measures with female partners of childbearing potential.
* Understands the correct technique for the use the nebulizer device(s).
* Other inclusion criteria apply

Exclusion Criteria:

* History or presence of clinically significant medical or psychiatric condition.
* Abnormal ECG measurements at Screening.
* Any signs of respiratory tract infection within 6 weeks of Screening.
* Subject who has a current bacterial, parasitic, fungal, or viral infection; any infection requiring hospitalization or intravenous antibiotics within 6 months prior to Screening.
* Positive test for SARS-CoV-2
* Subject has any condition of the oro-laryngeal or respiratory tract.
* Uses or has used tobacco or nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, patches etc.) within 6 months prior to screening
* Additional exclusion criteria apply