cyrilzakka/clinical-trials huggingface dataset:
Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients

A phase 4 clinical investigation in iron-replete pediatric hemodialysis patients, whose legal guardian had provided signed informed consent, and who had satisfied the inclusion and exclusion criteria of the study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female pediatric ESRD, Patients \>_ 2 and \<_ 16 years of age, whose legally authorized representative provided signed informed consent.
* Stabilized on chronic hemodialysis therapy with an identified need for maintenance iron therapy.
* Predetermined TSAT and serum Ferritin (at the screening visit).
* Receiving a stable EPO dosing regimen.

Exclusion Criteria:

* Receipt of any form of iron supplementation during the 2 weeks prior to the first Ferrlecit dosing.
* Hypersensitivity to Ferrlecit or any of its inactive components.
* High TSAT level.
* High Serum Ferritin
Non-invasive Brain Stimulation in Patients With Methamphetamine Use Disorder

The study aims to apply the intermittent theta burst transcranial magnetic stimulation (iTBS) treatment and evaluate the effect in improving craving, affective symptoms, and cognitive function for those participants in the community with amphetamine use. An electroencephalography and blood biomarkers will also be examined to explore the possible mechanisms.

In this study, participants with amphetamine use will be recruited from psychiatric clinics. They will be randomly assigned to two different transcranial magnetic stimulation groups, the iTBS and sham groups. Those participants to receive 1-3 sessions in a single day at an interval of 15 minutes, and 5 high-frequency iTBS sessions per week in total four weeks. After the completion of the four-week course, the severity of symptoms for the next one month and three months will be tracked.

Eligibility Criteria:
Inclusion Criteria:

1. Age ranged 20-65.
2. Diagnosis as amphetamine use disorder by clinical psychiatrist according to DSM-V

Exclusion Criteria:

1. Major disorders other than substance use disorders in Diagnostic and Statistics Manual-5 (e.g. Schizophrenia, organic brain syndrome, and bipolar disorders).
2. Epilepsy, head trauma, migraine, cardiovascular comorbidity, atypical parkinsonian disorder
3. patients with heart pacemakers, implanted drug delivery aids, artificial electronic ears, implantable defibrillators, and/or implanted nerve stimulators, and near the implants mentioned above.
4. patients with metal implants above the chest.
5. people who have damaged skin in areas of the patient's body that receive stimulation.
6. patients with multiple sclerosis.
7. patients who have extensive ischemic scarring.
8. pregnant women.
9. patients with a family history of spasms/epilepsy
10. patients taking medications that may lower the seizure threshold.
11. patients with severe sleep disorders related to previous rTMS treatment.
12. patients with severe heart disease
13. patients with intracranial stress caused by uncontrollable migraines.
14. people who have been evaluated by a physician as unfit to participate in clinical trials.
Technology-assisted Conscientiousness Therapy for People With Multiple Sclerosis

This is a validation study of a conscientiousness-based phone app intervention strategy to help people with their health management and employment.

The primary objective is to establish whether people with MS with low Conscientiousness benefit from a cognitive-behavioral, phone app intervention. Also enrolled are healthy individuals over the age of 60. This group's response to the intervention will be compared to the MS sample. The investigators also aim to determine the acceptability and utilization of the Conscientiousness-Coach phone application and intervention. It is anticipated that the Conscientiousness-Coach phone app intervention will result in fewer negative work events and increased work accommodations in those treated, relative to the control group. In exploration of other secondary outcomes, the investigators also expect that the treatment will result in increased self-report trait Conscientiousness itself, increase in structured leisure activities, reduction in depression, and reduction in anxiety.

This is a prospective longitudinal design with an experimental manipulation (i.e., a randomized-controlled trial). There will be an initial assessment with neuropsychological testing, the Buffalo Vocational Monitoring Survey (BVMS), and several self-report measures, and a post-test assessment after three months and six months with these same instruments, excluding the neuropsychological assessment. The BVMS will also be administered at 0 months, 3 months, and 6 months to further assess post-treatment effects.

Eligibility Criteria:
Inclusion Criteria:

* Has a diagnosis of Multiple Sclerosis or is over 60 years of age.
* If an MS patient: is above 18 years of age.
* No history of substance dependence/abuse, psychiatric disorders, or any neurological disease other than MS
* If an MS patient: has a NEO-FFI Conscientiousness score that is one standard deviation or more below the healthy adult mean (t=40)

Exclusion Criteria:

• Does not meet one or more of the above inclusion criteria
Metabolic Reprogramming of Monocytes in Inflammatory Flares of Inflammatory Bowel Diseases

Inflammatory bowel diseases, Crohn's disease and haemorrhagic rectocolitis, are pathologies that progress in flare-ups, impacting on patients' quality of life and functional or even vital prognosis. These inflammatory diseases require the use of immunosuppressive and immunomodulatory treatments, the side-effects of which can be significant, and the limited number of which sometimes puts patients and practitioners in a therapeutic impasse from which surgery is the only way out. It is therefore important to be able to develop new therapeutic approaches, ideally better tolerated, that can control inflammation during relapses. Monocytes are one of the main players in the inflammatory reaction. In the laboratory, we have developed a strategy for the metabolic reprogramming of these cells based on the use of oxygen microbubbles to modulate the inflammatory response of monocytes.


Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18
* Managed at the CHUGA for a severe IBD flare-up requiring hospitalisation or endoscopy for flare-up
* Patient not objecting to the REPRO-MICI study

Exclusion Criteria:

* Patients protected by law (pregnant or breast-feeding women, minors, patients under guardianship or trusteeship, persons deprived of their liberty or hospitalised under duress).
* Patients with positive HIV, HBV or HCV serology.
* Patients with a positive ELISPOT with no history of treatment for latent tuberculosis.
Analysis Of Sensory Recovery Of Donor Size And Quality Life In Oral Cancer Patients

The aim of the study is to investigate post-surgery sensory impairment and life quality changes in oral cancer patients who underwent free flap (Free Flap) on post-operative 6 months, 12 months, and 24 months, respectively


Eligibility Criteria:
Inclusion Criteria:

1. patients with American Society of Anesthesiologists physical status I-III
2. Older than 20 patients
3. Diagnosis of oral canaer ,requiring free flap reconstruction

Exclusion Criteria:

1. Diagnosis of a serious mental illness involving formal thought disorder (e.g., schizophrenia) documented in medical record
2. Cognitive with dementia, delirium
Singulair Use in Non-Allergic Rhinitis Eosinophil Syndrome (NARES)

The purpose of this trial is to determine if patients with NARES treated with montelukast (Singulair) will have improved nasal symptom scores and reduced nasal eosinophils.

Patients will receive either montelukast or placebo in the treatment of NARES. 4 visits will be conducted over 12 weeks. A history and physical will be performed at the beginning of the trial and at the end. Skin testing will be done at Visit 1. Nasal smears and lavages will be performed at every visit. Patients will be compensated for time and travel.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 - 65 years
* Diagnosed with NARES

Exclusion Criteria:

* Smokers, exposed to passive smoke
* Diagnosis of seasonal allergic rhinitis (SAR), perennial allergic rhinitis (PAR), or vasomotor rhinitis (VMR)
Cold Water Exposure and Immune Function Study

The purpose of this clinical trial is to explore the effects of a 4 week cold-water immersion (CWI) intervention on measures of immune function, sleep quality, mental health and well-being, and muscular strength. The main questions it aims to answer are:

* Does a 4 week CWI intervention improve measures of immune function, sleep quality, mental health and well-being, and muscular strength?
* Are there any differences in these measures when comparing cold tubs versus cold showers?

Researchers will compare chronic use of cold tubs to cold showers to see if cold water immersion may improve overall immune health and well-being.

Participants will:

* Undergo 4 weeks of Cold Tub or Cold Shower interventions at a frequency of 3 times a week for 4 minutes, if placed in the CWI intervention groups
* Undergo testing measures at the two pre- and post- intervention time points, if placed in the healthy control group or the CWI intervention groups


Eligibility Criteria:
Inclusion Criteria:

* Males and Females
* Aged 18-45

Exclusion Criteria:

* Currently practices CWI for \[\&gt;3 times in the last month\]
* Pregnant or planning to become pregnant
* Chronic use of anti-inflammatory medication
* Prior history of chronic disease conditions:
* Cardiovascular Disease
* Diabetes
* Cancer
* Raynaud\&#39;s Disease
* Severe and untreated anxiety or depression
Eeva 12-well Dish Study

The purpose of this study is to demonstrate that the Eeva™ System is compatible with the Eeva 12-well Dish.

This study is designed to demonstrate that the Eeva System Software successfully tracks the embryo images and identifies the timing of key developmental events using the Eeva 12-well Dish.

This is a prospective, observational, blinded, single arm, nonrandomized, single center clinical study. Images of developing embryos and Eeva predictions will be blinded to embryologists and physicians

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
* Subject is at least 18 years of age.
* Subject has basal antral follicle count (BAFC) ≥ 12 prior to stimulation cycle.
* Subjects has basal FSH \< 11 IU
* Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
* Subject has at least 8 normally fertilized eggs (2PN)
* Willing to have all 2PN embryos monitored by Eeva
* Willing to comply with study protocol and procedures and able to speak English.
* Willing to provide written informed consent.

Exclusion Criteria:

* Reinseminated eggs.
* History of cancer.
* Gestational carriers.
* Planned preimplantation genetic diagnosis or preimplantation genetic screening.
* Previously enrolled in this study
* Concurrent participation in another clinical study.
* Any other reason the Investigator believes the subject should not participate in the clinical study.
Does Hypnosis Improve Severe Sleepwalking ?

The aim of the study is to compare the benefit of two cognitive therapies in severe sleepwalking/ sleep terrors: relaxation vs. relaxation plus hypnosis. This is a monocentric, double-blind controlled study. 75 patients (aged more than 15 yo) with severe sleepwalking (defined as at least one epsidoe per week and at least two awakenings in stage N3 on video polysomngraphy) will be included. All patients will have a visit 1 for diagnosis including a medical interview, a video polysomnography, questionnaires on sleepwalking (PADSS and systematized interview), sleep quality (PSQI, MEQ) and sleepiness (Epworth scale) and suggestibility scale. 25 patients will be randomized to the relaxation group, 25 patients to the hypnosis plus relaxation group, while the 25 non-randomized patients will be non-treated controls. Randomized patients will receive the therapy on day 1, and be monitored during the subsequent night. They will have a weekly therapy for 4 additional sessions and be monitored again on Month 1, as well as they will complete the sleep and sleepwalking questionnaires. They will also complete the questionnaire by phone on Month 3. The non-randomized controls will complete the questionnaire on month 1, with no therapeutical intervention between Day 1 and Month 1. The main outcome will be the frequency of sleepwalking episodes, as assessed by the PADSS-B. Secondary outcomes include the changes in other subitems of teh PADSS, of the N3 awakenings in v-PSG between night 1 and Night 2 (short term effect) and Night 1 and Night 28 (long term effect), as well as changes in sleep quality and sleepiness scales. A comparison of spectral EEG, as well as respiration, eye movements, muscle tone and heart rate during rest, hypnosis trance, relaxation and sleepwalking episodes is also scheduled.

Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures

Eligibility Criteria:
Inclusion Criteria

1. \>15 years old
2. French speaker
3. having signed the Informed consent form
4. Affiliated to National Health Insurance
5. Sleepwalking or sleep terrors (ICSD-3 criteria);
6. At least 2 awakenings from N3 on Night 1 videopolysomnography;
7. At least one episode per week.

Exclusion Criteria

1. \< 15 years old
2. Patient under guardian ship
3. Patient unable to understand the protocol
4. Patient unable, from investigator's opinion, to comply to the procedures of the trial, including the ability to practice self-hypnosis.
Mometasone Furoate and Oxymetazoline in the Treatment of Adenoid Hypertrophy

The purpose of this study is to determine the effect of MF/OXY in the treatment of adenoid hypertrophy children with severe allergic rhinitis.

The investigators performed a two stages, parallel, randomized, double-blind, double-dummy, clinical trial in 240 AH children concomitant with perennial allergic rhinitis. In the first treatment stage, the 240 children were assigned to MF (50μg, 1 puff in each nostril every evening) or control group (normal saline) after two week's run-in period. After 6 week's treatment, the children in MF group were evaluated and grouped as responders and non-responders according to subjective symptoms and objective performance.

Responders were followed up for six months and reassessed. Non-responders underwent 2-week washout period and were randomly assigned to 4 groups receiving the following treatments: placebo, OXY (0.05%, 1 puff in each nostril every evening) or MF (50μg, 1 puff in each nostril every evening). All participants received 8 weeks' MF or its placebo plus one week's OXY or its placebo for every second week. After that, the patients were followed for six months and the evaluation was done at different time points.

Eligibility Criteria:
Inclusion Criteria:

* adenoid occluding at least 75% of the nasopharynx at nasal endoscopy
* age between 5 and 11 years
* chronic obstructive nasal symptoms no less than 12 months
* moderate-to-severe AR

Exclusion Criteria:

* tonsillar hypertrophy
* upper respiratory infection within the last 2 weeks
* sinonasal anatomic anomalies or diseases
* craniofacial malformations
* genetic diseases (i.e., Down's syndrome)
* neurologic or cardiovascular diseases
* immunodeficiency
* history of epistaxis
* asthma
* hypersensitivity to MF or OXY
* undergoing intranasal, topical, or systemic steroid or antibiotic treatment within the past 4 weeks
Hemodynamic Effects of Dexmedetomidine in Septic Shock

The current treatment regimen of patients with septic shock requires a sufficient hemodynamic support aiming to preserve tissue oxygen requirements and perfusion. Therefore, aggressive fluid challenge and vasopressor agents play a pivotal role. To increase total peripheral resistance and preserve organ perfusion, a continuous infusion of catecholamines is often needed. Because sepsis is usually associated with adrenergic receptor and post-receptor abnormalities, the efficacy of such treatment regimens often gradually decreases over time, thereby complicating hemodynamic support. Experimental evidence suggest that α-2 agonists increase pressor responsiveness following lipopolysaccharide administration. This study will assess the effects of the sedation with dexmedetomidine (α-2 agonist) on norepinephrine requirements in patients with septic shock.

The present study was designed as a prospective study. All patients enrolled in the study will require norepinephrine to maintain MAP between 65 and 75 mmHg despite adequate volume resuscitation and will be sedated according to istitutional guidelines with propofol and remifentanyl. After 8 h had elapsed during stable hemodynamic conditions, an initial set of measurements will be obtained during the sedation with propofol and remifentanyl. This set of measurements will be considered as baseline. In the patients in which conventional sedation will be replaced by dexmedetomidine and remifentanyl, a second set of measurements will be obtained after 4 h had elapsed during stable conditions. A final set of mesurements will be obtained after another 8-h period in stable conditions after switcheing back again to propofol and remifentanyl, .

During the observational period the dosage rate of norepinephrine will be adjusted to maintain the same threshold MAP of 65-75 mmHg All other medications were held constant.

Eligibility Criteria:
Inclusion Criteria:

* septic shock
* need for sedation

Exclusion Criteria:

-
Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant

Irritable bowel syndrome is a highly prevalent disorder and consumes many health resources. Its physiopathogenesis is multifactorial. Some of the factors involved have to do with the alteration of the intestinal microbiota, low-grade inflammation and the alteration of intestinal permeability. Specific tannins have been shown to have prebiotic effects and could be useful in treating this condition. This is an exploratory before-after study that aims to evaluate the effect of a chestnut and quebracho extract on the symptoms of IBS diarrhea predominant, serum cytokine levels, microbiota and intestinal permeability, as well as on metabolomics.

In vitro studies have shown that chestnut and quebracho extract has a prebiotic effect of modulating the intestinal microbiota, but also, bacterial fermentation produces metabolites with powerful anti-inflammatory effects such as quecetin. Irritable bowel syndrome (IBS) is a multifactorial disorder involving factors related to the intestinal microbiota, low-grade inflammation, and impaired intestinal permeability.

In this study, 30 patients with predominant IBS diarrhea and 50 healthy controls will be included. IBS patients will receive chestnut and quebracho extract twice a day for 8 weeks. They will be measured at baseline and at 8 weeks: 27 serum pro and anti-inflammatory cytokines and serum zonulin. Likewise, the intestinal microbiota and metabolomics will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* IBS patients: Both sexes with a diagnosis of irritable bowel syndrome variety diarrhea according to the Rome IV criteria

Healthy Controls: Relatives of patients who do not show any disease, who do not take medication or present symptoms.

Exclusion Criteria:

* patients with digestive tract disease,
* systemic diseases such as severe heart, kidney or liver failure,
* history of previously known digestive tract surgeries and / or intestinal adhesions,
* diabetes mellitus,
* cirrhosis,
* inflammatory bowel disease,
* celiac disease,
* patients with cognitive impairment,
* alcoholics,
* lack of consent .
* patients who have received antibiotics in the last month.
Intra-articular Pulsed Radiofrequency Neuromodulation Versus Intra-articular Steroids for Painful Knee Osteoarthritis

To compare the efficacy of intra-articular pulsed radiofrequency to intra-articular steroids in patients with moderate-severe painful osteoarthritis of the knee.

Patients Adult patients with intractable knee pain for more than 6 months and radiographic evidence of grade II, III or IV knee osteoarthritis. Must not have had a knee injection or other interventional procedure for knee pain within the past 12 weeks. Must be on stable medications for the past 12 weeks and willing to keep medications stable for the first 12 weeks of the study.

Study Design Pilot study will enroll 30 patients randomized 1:1:1.

1. Active control - intra-articular 4 milliliters 0.5% bupivacaine + 10mg dexamethasone + sham Pulsed Radiofrequency
2. Placebo control - intra-articular 5 milliliters 0.9% saline + sham Pulsed Radiofrequency
3. Treatment group - intra-articular 5 milliliters 0.5% bupivacaine + Pulsed Radiofrequency

Methods Two 18-gauge radiofrequency needle with 10 millimeter active tip will be placed intra-articularly from an anterolateral and anteromedial approach to target the medial and lateral compartments. Once satisfactory fluoroscopic placement is noted, the Pulsed Radiofrequency or sham-Pulsed Radiofrequency treatment will be administered. Subsequently, the injectate will be administered. Dexamethasone is selected as the corticosteroid as it is colorless and will be indistinguishable from the saline used in the Intra-articular Pulsed Radiofrequency and placebo groups.

Eligibility Criteria:
Inclusion Criteria:

* Capable of giving written informed consent
* Patients aged 18 years or older
* Patients with unilateral or bilateral knee pain for at least 3 months
* Radiographic evidence of knee osteoarthritis
* Appropriate candidate for steroid injection as determined by the investigator

Exclusion Criteria:

* Chronic knee pain caused by infection, inflammation, tumors, and fractures
* A history of acute knee pain, previous knee surgery, connective tissue diseases, progressive neurologic disease or uncontrolled psychiatric disorders
* The administration of steroids or hyaluronic acids within the last three months
* Coagulation disorders
* Local infection at the site of intervention planned
* Active litigation related to this pain complaint
The Effect of Different Treatment Modalities of Tubal Ectopic Pregnancy on Ovarian Reserve: a Prospective Cohort Study

Detect the effect of different treatment modalities of tubal ectopic pregnancy on ovarian reserve


Eligibility Criteria:
Inclusion Criteria:

* The study will include patients aged 18-44 years with known diagnosis or suspicion of diagnosis of tubal ectopic pregnancy (abnormal doubling rates of their b-HCG levels as well as ultrasonographically identified or unidentified gestational sacs outside the uterus)
* Included patients must have capacity to provide informed consent. Given the potential emergent nature of presentation, women will not be recruited if fully informed consent could be compromised due to a highly distressed emotional state or significant hemorrhage necessitating the need for urgent surgery

Exclusion Criteria:

1. The use of hormonal contraceptives within two months of enrolment
2. If other surgery was conducted at the time of salpingectomy.
3. If a woman was pregnant at follow up visit for AMH measurement
4. History of previous surgeries of fallopian tubes and/or ovaries