cyrilzakka/clinical-trials huggingface dataset:
ORIGIN® PS Modular & Associated Instruments

The study objective is to evaluate safety and performance of the ORIGIN® PS (postero-stabilized) Modular devices and associated instruments, more precisely to evaluate safety by the proportion of patients requiring a revision (i.e. revision rate) at 2-6 months, 1y and 2y post-procedure and to evaluate performance by means of a Knee Society Score (KSS) Score at 2-6 months, 1y and 2y post procedure.

The hypothesis raised for this study, regarding the scoring, is that patients will experience a marked improvement in the natural feel of the prosthesis during the first year after the surgery, and slightly significant improvement at the following interval of 2 years. The overall patient satisfaction is expected to be improved after 2 years follow-up with ORIGIN® PS Modular.

The study is ambispective, post market, non-comparative, non-randomized, multicentric and observational in which 200 patients will be enrolled to evaluate the safety and performance of the ORIGIN® PS Modular devices and associated instruments.

Patients will be included in the study during 18 months (inclusion window) and followed-up for 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years of age.
* Patient, or if applicable, his or her guardian or legal representative, willing to give informed consent.
* Clinically indicated for first intention total knee replacement.
* Geographically stable and willing to return for all follow-up visits or, at a minimum, to complete the patient self-report score.

Exclusion Criteria:

* Vulnerable subject (as defined in ISO-14155)
* Acute or chronic, local or systemic infection,
* Muscular, ligamental, neurological, psychological or vascular deficits,
* Bone destruction or poor bone quality likely to affect implant stability.
* Any concomitant condition likely to affect implant integration or function,
* Allergy or hypersensitivity to any of the materials used,
* For devices in CoCr Mo (ISO 5832/4): renal and hepatic impairment,
* Hip Knee Ankle (HKA) angle \< 165° or \> 195°,
* Severe collateral ligament deficiency (requiring a more constrained prosthesis),
* Major anatomical deformities,
* Severe flexion contracture or severe recurvatum,
* Revision of a partial or total knee prosthesis,
* Non-extractible material (e.g., screw, plate, intramedullary nail, osteosynthesis material) which can create a conflict with any component of the prosthesis,
* Distal and/or posterior and/or anterior femoral bone loss which exceeds the femoral component thickness,
* Proximal tibial bone loss which exceeds the tibial component thickness (tibial tray + tibial insert),
* Bone degradation requiring an anchoring stem for femoral component
Study of Application of Transcutaneous Trigeminal Nerve Stimulation on Autism Spectrum Disorder

This study aims to evaluate the safety and the efficacy of applying transcutaneous trigeminal nerve stimulator (NuEyne P01) on autism spectrum disorder.

Duration of study period (per participant): Screening period (-28\~0 days), Intervention period (28 days) Patient needs to visit site at least 4 times (V1, V2, V4, V6). V2 can be done with V1. Tele-visit should be done on V3 (day 7), V5 (day 21).

Eligibility Criteria:
Inclusion Criteria:

* Children over 7 years old and under 12 years old
* Patients diagnosed with autism spectrum disorder
* A person who has a total intelligence index of 70 or higher and has no problems with basic language communication
* A person who agrees not to use any medical device other than this clinical trial medical device during the clinical trial period
* A person who does not take a concurrent drug from screening to the end of the study, or who can maintain the concurrent drug during the clinical trial period without any change or addition
* Voluntary written consent to participate in this clinical trial

Exclusion Criteria:

* Those who participated in other clinical trials within 30 days from the screening date
* If it is difficult to understand the contents of treatment due to the limitation of intelligence index or language ability, and if it is difficult to conduct a study
* When there is a risk of clinically significant behavioral problems, emotional control problems, psychiatric symptoms, self-harm, or other harm that can affect the treatment process
* Psychiatric hospitalization history
* A person with acute or chronic medical or mental illness
* A person with a history of seizures
* Serious trauma and surgery within 1 month
* A person who is deemed to have a problem with the adhesion of electrodes due to inflammatory reactions or other dermatological problems on the skin around the forehead to which electrodes of clinical trial medical devices are attached
* If it is need to take sleep medications \[benzodiazepine, melatonin, trazodone\] (\*However, it is participated after having a washout period of at least two weeks.)
* A person who is deemed to have other reasons for prohibition of use of clinical trial medical devices (including heart-related problems, seizures, metal or electronic devices implanted in the head, people with unknown pain, pacemaker transplant, etc.)
* When it is determined by the researcher that it is difficult for the subject to continue voluntary participation in the study due to the lack of cooperation and motivation for treatment
* Other cases where it is deemed difficult to participate in the study by the researcher's judgment
Data Collection and Analysis in Brainstem Surgeries

The hypothesis is that the structural documentation and analysis of the data of demographics, neuroimaging, IONM and clinical outcomes can help to further standardize the use of such equipment for detecting the integrity of the corticospinal tracts.

We want to confirm that the retrospectively data analysis of neuroimaging, IONM and clinical outcomes does help to understand these methods better in the surgical management of brainstem lesions, and therefore, improve the safety of brainstem surgery.

This will be a prospective data collection and retrospective data analysis study to investigate the effect of pre- and post-neuroimaging, intraoperative monitoring, and clinical outcome during the surgical management of brainstem lesions in our neurosurgical center. The data of demographics, neuroimaging, IONM and patients' outcomes will be acquired based on the medical records and follow-up visits. All data is stored in the personal file of the clinical information system for each patient. The expected duration of each subject's participation is confined to the surgery itself and the routine visits during the follow-up. The overall study duration is expected to collect all the brainstem surgery in next five years.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 - 80 years' old
* With lesions in or near the brainstem
* Patients who are suitable for brainstem surgery
* Patients who accept the surgery
* Patients who signed the informed consent

Exclusion Criteria:

* Patients age \< 18 years
* Patients who are not suitable for brainstem surgery (for example patients in coma, very small lesion, pregnancy)
* Patients unlikely to attend the follow-up 12 months after surgery
Multicenter Study on the Toxicity of Gluten Traces in the Treatment of Celiac Disease

The purpose of this study is to evaluate the toxicity of minute doses of gluten in the treatment of celiac disease, a disorder characterized by permanent intolerance to dietary gluten.

Treatment of celiac disease (CD) is based on the complete avoidance of gluten-containing products in the diet. However it is not known whether tiny amounts of gluten are harmful for patients on long-term treatment. This is an important issue, as even a strict gluten-free diet (GFD) is usually contaminated by traces of gluten, e.g. in wheat starch and processed food. The aim of this study is to investigate the toxicity of the prolonged ingestion of gluten traces in treated CD patients. This is a prospective, placebo-controlled, double-blind study. Patients are adults with biopsy-proven CD on treatment with the GFD for at least 2 years. During the study period their background daily gluten intake is kept lower than 5 mg. After baseline evaluation, patients continue their GFD and are assigned to ingest 0 mg, 10 mg or 50 mg of daily gluten (incorporated in a capsule) for 90 days. The following evaluations are performed both at baseline and after the micro-challenge: clinical, serological (anti-transglutaminase and antigliadin antibodies), and small intestine histology.

Eligibility Criteria:
Inclusion Criteria:

adults with biopsy-proven celiac disease on a gluten-free diet for at least 2 years and in apparent good health -

Exclusion Criteria:

1. patients younger than 18 years old;
2. poor compliance to the gluten-free diet;
3. abnormal results at the baseline evaluation (positivity of anti-tissue transglutaminase (tTG) antibodies and/or definitely abnormal small intestinal biopsy;
4. associated conditions, such as selective IgA deficiency or other autoimmune diseases -
Modulation of Free Fatty Acids in Heart Failure Patients With Diabetes: "Effect on Left Ventricular Function"

The investigators wish to investigate the the short term effect of low circulating free fatty acids in congestive heart failure patients with type 2 diabetes.

Hypothesis: Low levels of circulating free fatty acids decrease myocardial and peripheral muscle lipid content, improves cardiac performance and exercise capacity.


Eligibility Criteria:
Inclusion Criteria:

* ejection fraction at or lower than 45%
* type 2 diabetes

Exclusion Criteria:

* known s-creatinine \>220mM
* known S-alanine aminotransferase \>3 times normal upper limit
* other disabilitating conditions
* pregnancy
* insulin treatment
Chinese Nutritional Risk Screening and Intervention Registration Study in Geriatric Patients

This study is a multi-center observational study, led by the Department of Geriatrics, Peking Union Medical College Hospital, with 99 tertiary hospitals as sub-centers. Patients in the geriatrics department from September 2020 to September 2021 are consecutively enrolled .Basic information and nutritional risk assessment is registered and the outcome within 90 days after hospitalization will be recorded.Daily energy, protein and fiber are 75% of the target amount as the standard for feeding.

This study is a multi-center observational study.Patients in the geriatrics department from September 2020 to September 2021 are consecutively enrolled .The patients' basic information, nutritional assessment, diet and blood biochemical indicators after hospitalization will be registered.The status of nutritional treatment and rehabilitation training and whether there is any adverse outcome when discharged from the hospital will be recorded. Daily energy, protein and fiber are 75% of the target amount as the standard for feeding.The diet, exercise status and adverse outcomes of participants within 90 days after hospitalization will be followed up through outpatient, telephone or remote consultation.Primary endpoint-the impact of nutritional therapy (energy, protein, dietary fiber compliance or failure) on mortality, new infections, falls and readmissions in elderly hospitalized patients within 90 days after hospitalization; secondary endpoints-the change of the nutrition indicators, the physical function and quality of life of the participants within 90 days after hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥65 years old in geriatrics;
* Expected hospitalization ≥4 days;
* Patients with NRS 2002≥3 points;
* Sign informed notice.

Exclusion Criteria:

* End-stage patients (estimated survival time ≤ 3 months);
* Transfer to other departments during hospitalization;
* Contraindications to nutritional therapy (such as hemodynamic instability);
* Have participated in other nutritional research projects.
Brain Activity During Sexual Behavior in Patients With Primary Premature Ejaculation a Clinical Trial

This is a controlled study of patients with and without primary premature ejaculation. It is based on near-infrared spectroscopy (NIRS) functional brain imaging to detect and compare changes in brain activity in resting and task states (Simulated Sex) between the two groups of patients.


Eligibility Criteria:
Inclusion Criteria (primary premature ejaculation subjects):

* patients' age varied from 18 to 45 years；
* patients met the 2014 International Society for Sexual Medicine (ISSM) definition criteria for PPE；
* patients had a stable, heterosexual relationship with a single sexually active female partner for at least 6 months and with at least two sexual intercourses a week and kept stable during the study period;
* Patients with premature ejaculation lasting longer than 6 months；
* patients were identified if their scores were higher than 9 on the Chinese version of Premature Ejaculation Diagnostic Tool (PEDT);
* patients had no history of any previous therapies for PE or had recently stopped the therapies for at least 3 months
* patients had fully informed consent, signed informed consent form

Inclusion Criteria (Non-premature ejaculation subjects):

* Men between the ages of 18-45 years were included according to an age difference of \<3 years between each patient and the primary premature ejaculation group, and if more than one volunteer was eligible at the same time, the one with the closest age was selected；
* Patient does not meet the 2014 International Society for Sexual Medicine (ISSM) criteria for defining premature ejaculation；
* patients had a stable, heterosexual relationship with a single sexually active female partner for at least 6 months and with at least two sexual intercourses a week and kept stable during the study period;
* patients had fully informed consent, signed informed consent form；

Exclusion Criteria:

* patients were diagnosed with secondary PE, variable PE, and subjective PE;
* patients were using medications for endocrinological, metabolic, chronic systemic, or psychiatric diseases;
* patients were abusing alcohol or illegal drugs；
* patients were diagnosed with erectile dysfunction (ED) if their scores were \<21 on the abridged five-item International Index of Erectile Function (IIEF-5)
* patients were diagnosed with sexual hormone abnormalities, hyperthyroidism, hypothyroidism, Peyronie's disease, prostatitis, urethritis, or urinary tract infection;
* patients with head injuries that prevent them from completing near-infrared light brain function imaging
* Patients with severe schizophrenia, anxiety, depression or other neurological symptoms or poor compliance
Therapeutic Oxygen for Gastrointestinal Atony (TOGA)

This study is a non invasive study to see if 100% oxygen therapy will help to resolve an intestinal obstruction.

TOGA involves the provision of a 6- hour treatment with 100% oxygen via non breather mask to hospitalized patients with ileus, small bowel obstruction and/or colonic pseudo-obstruction will be a useful supplemental therapy, decreasing the diameter of the intestinal lumen and enhancing resolution of ileus/pseudo-obstruction

Eligibility Criteria:
Inclusion Criteria:

* patient or health proxy has been adequately informed of risks and benefits and agrees to his/her participation in the study.
* patient is a hospitalized inpatient diagnosed with ileus, bowel obstruction or colonic pseudo-obstruction \[clinician interpretation or small bowel diameter ≥3.5 cm, cecal diameter ≥ 9 cm, sigmoid colon diameter ≥ 6 cm\].
* patient is clinically and hemodynamically stable
* patient does not require supplemental oxygen greater than 2 liters per minute via nasal cannula
* patient does not have any respiratory contraindications to 100% oxygen
* failure to respond to non-surgical/non-endoscopic therapy for at least 24 hours, therapy at discretion of treating physician \[to eliminate patients with trivial ileus not requiring advanced intervention\]

Exclusion Criteria:

* patient is not expected to survive in the short term.
* patient is a pregnant or lactating woman.
* patient presents with severe or unstable psychiatric disorders.
* patient is participating in concomitant research studies that would interfere with this study.
* patient is an alcohol or drug abuser.
* respirator support required.
* unable to tolerate 100% oxygen for respiratory reasons or any other reasons.
* perforation of the viscus.
* inability to obtain informed consent.
* hypoxemia, as in room air oxygen saturation less than 90%.
Patients' Experiences During Endodontic Treatments Performed by Hospital Externs at the CHRU of Brest

Root canal treatment (RCT) consists in eliminating infected and / or inflammatory tissues inside the root canal system of the tooth by a chemo-mechanical preparation and then filling the latter in a three-dimensional, bacteriostatic and durable way to allow healing. This treatment is commonly carried out and can sometimes be long and tedious, as for example on molars with several roots.

According to numerous studies, patients consider endodontic treatments as one of the most stress-inducing dental procedures. Another study also reports satisfaction during root canal treatment in public health service. There is a paucity in literature about patients'experience of endodontic treatment when they are carried out by dental students.

The main objective of this study is to investigate patients' experience of root canal treatment in Brest dental university hospital through a qualitative methodology, with individual interviews, a verbatim transcription, followed by a qualitative analysis . This type of research can enable to keep a broad approach of patients' experience and to stay faithful to it.

Volunteer patients are recruited during their endodontic treatment in Brest Dental Hospital. At the end of the treatment, the patients are asked to take part in an individual interview. The interview is carried out by a single investigator with the help of a question route, until data saturation. The interviews are transcribed verbatim and anonymously by the main investigator. The interviews are read by qualitative Analysis by two investigators in order to determine codes, gathered in categories. Then, the results will be written and discussed in an article.

Eligibility Criteria:
Inclusion Criteria:

* Patients of legal age who volunteered to participate in the study, having formulated their non-opposition
* Patients having been treated in the dental department of Brest dental university hospital by a dental student for an endodontic (=root canal) treatment

Exclusion Criteria:

* patient who has formulated his opposition
* patients not requiring endodontic treatment
* minor patients
* patients treated by the consultants or residents
* patients taking opioids, powerful psychotropic drugs or having taken Atarax® before the treatment or interview
* patients who are cognitively impaired or have a disability that impairs comprehension (hearing, speech)
* patients under the influence of drugs or alcohol
Lipoarabinomannan (LAM) in Urine for Diagnosis of Pulmonary Tuberculosis in HIV Patients

A diagnostic validity study in which urinary LAM was done in seropositive HIV patients with symptoms suggestive of TB who were included and investigated with battery of tests to reach the final diagnosis.

A diagnostic validity study in which urinary LAM was done in seropositive HIV patients with symptoms suggestive of TB who were included and investigated with battery of tests to reach the final diagnosis.

The study was conducted at Mansoura Fever Hospital in collaboration with the Chest Department and Clinical Pathology Department, Mansoura University, Egypt, from January 2015 to October 2016.

Ethical approval had been obtained from Medical Research Ethics Committee of Faculty of Medicine, Mansoura University (code no: MD/138). Approval from Egyptian Ministry of Health was taken (No: 1-2016/18). Patients signed their written consents after detailed explanation of the study protocol.

Eligibility Criteria:
Inclusion Criteria:

* The study included seropositive HIV patients with a new diagnosis of either pulmonary or extra-pulmonary TB, and also included patients who were presented by symptoms suggestive for tuberculosis, changes in chest X ray that not improved by full course of antibiotics or positive tuberculin test ≥ 5 mm.

Exclusion Criteria:

* Patients on anti-TB drugs or negative screening for sero-positive HIV patients were excluded from the study.
Genetic Polymorphism as Moderator of the Effect of an Acute Bout of Exercise on Cognitive Function

Studies have shown that an acute bout of aerobic exercise positively effects cognition, mainly executive functioning; however the effect is not observed among all people and it is not clear whether only aerobic exercise can produce this effect or possibly also resistant exercise. The main purpose of our study is to examine whether genetic variation is a moderator of this effect and whether resistant exercise is comparable to aerobic exercise in improving cognition following a single bout of exercise.


Eligibility Criteria:
Inclusion Criteria:

* Physical Education Students
* Able to sign consent form

Exclusion Criteria:

* Competitive athletes
* Smokers
* Neurologic or psychologic orders
* Chronic diseases
* Head Injuries
* Hospitalization in the previous 3 months
* Pregnant
Postexercise Hot-Water Immersion on Exercise Performance in Hypoxia

The purpose of this study is to determine the effect of 5 days post-exercise hot water immersion on exercise performance at simulated altitude.

Human performance is compromised at altitude due to a lower partial pressure of oxygen and subsequent reductions in the convective transport of oxygen to tissue. Long-term acclimation to attitude incurs physiological adaptations that result in a near return to sea-level performance; however, the time required (\~2 weeks) for such adaptations is often logistically challenging for athletes, military personnel or other individuals who reside at sea level. Recent research suggests that physiological acclimation to heat stress (i.e., heat acclimation) and altitude (i.e., hypoxia) share similar cellular adaptations, namely an up-regulation of Hypoxia-inducible factor 1 (HIF-1) and various heat shock proteins. Therefore, it is hypothesized that heat acclimation may provide physiological protection from reduced oxygen transport to the tissue and enhance performance at altitude. This cross-tolerance model is supported by traditional heat acclimation protocols (i.e., submaximal exercise in hot ambient temperature); however, it has not been tested with passive exposure to heat stress through post-exercise hot water immersion.

Eligibility Criteria:
Inclusion Criteria:

* Physically active (minimum of 90 minutes of moderate-intensity exercise per week)

Exclusion Criteria:

* Cardiovascular disease
* resident of \>1500 m above sea-level in the past year;
* history of fainting