cyrilzakka/clinical-trials huggingface dataset:
Plasma Concentrations of Prophylactic Cefazolin in Pediatric Patients Undergoing Cardiac Surgery With CPB

Surgical site infection (SSI) is a serious operative complication that may be associated with any surgical procedures. It increases morbidity and mortality after cardiac surgery. Plasma concentration of prophylactic antibiotic, routinely cefazolin, is altered by effects of cardiopulmonary bypass. This study is conducted to measure the plasma concentrations of cefazolin to determine its adequacy in pediatric patients undergoing elective cardiac surgery with cardiopulmonary bypass including its correlation with the incidence of postoperative SSI.


Eligibility Criteria:
Inclusion Criteria:

1. age \< 7 years old
2. undergoing elective cardiac surgery with cardiopulmonary bypass
3. receive cefazolin as prophylactic antibiotic

Exclusion Criteria:

1. Known or family history of penicillin or cephalosporins allergy
2. Coexisting liver or renal disease
3. Previous infection or received any antibiotics within 4 weeks
4. Previous surgery with median sternotomy
5. Predicted cardiopulmonary bypass time of less than 30 minutes or more than 150 minutes
6. Severe hemodynamic instability during the operation, requiring mechanical circulatory support
Suboccipital Myofascial Release Technique in Young Adults

When the literature is examined, although it is known that the suboccipital muscles are rich in proprioceptive receptors and have significant effects on balance, the effects of myofascial and neural relaxation of the suboccipital muscles on balance and proprioception are not fully understood. In this study, the investigators aim to examine the immediate effects of the SMV technique on balance and proprioception in young adults. With this study, by revealing the effects of the SMV technique on balance and proprioception, a different treatment option will be offered to clinicians working in the field of physical therapy and rehabilitation and interested in the rehabilitation of patients who may have balance and proprioception problems. It will also provide insight to academics working in this field in terms of the applicability of this technique among different patient groups.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-25
* Being healthy and not having one of the diseases specified in the exclusion criteria

Exclusion Criteria:

* Individuals with neck pain, neck trauma (fracture, whiplash syndrome), balance and proprioception problems, vestibular system problems, vertigo, cervical surgery, vision and hearing problems, any rheumatological, orthopedic, cardiovascular and neurological problems that may affect the cervical region
Postural Modification and Hearing Aids in Presbycusis

Presbycusis could be associated to increased risk to fall. There is little about the impact on postural balance of hearing aids. In this study, the investigators describe the postural balance evolution before and after hearing aid fitting in presbycusis-affected adults (55-80years old) consulting Angers University Hospital ENT department and ENT Medical Doctor of Le Mans .

After being informed about te study and consentment, patients meeting inclusion criteria consulting for presbycusis and in indication for hearing aids will be included to have posturometry (V0). Posturometry is performed 3 months later, before the first hearing aid installation (V1a) and after (V1b), as well as three months after hearing aid wearing (V2). Evolution of posturometry parameters without hearing aids between V0 and V1a serve as control and is compared to the evolution of posturometry parameters after hearing aid wearing between V1b and V2.

Eligibility Criteria:
Inclusion Criteria:

* 55 to 80 years old
* ARHL within PTA superior to 30dBHL, and intelligibility threshold 30dB or worse defining hearing aid fitting indication in France

Non inclusion Criteria:

* hearing aid fitting refusal or contrindication
* vestibulare rehabilitation in past 3 months
* unusual physical activity the day of the posturography test
* incapacity to understand the instruction, or to stand up the time of posturography without help
* predictable incapacity to perform posturography in the time of the study

Exclusion criteria:

* acute affliction that could affect the posturography test
* daily physical activity modification due to medical advice or vestibular rehabilitation between two posturography
Battlefield Acupuncture With Sodium Hyaluronate Injections

The study evaluates pain relief and subsequent range of motion changes combining battlefield acupuncture with sodium hyaluronate vs local anesthetic and sodium hyaluronate

Sodium hyaluronate is FDA approved for knee osteoarthritis. It is a widely used treatment for this condition. This does provide immediate pain relief and is often used in conjunction with lidocaine and ropivacaine to both improve pain relief and treatment tolerance.

battlefield acupuncture has been showing promise as an adjunct pain relief treatment option. If used during intra articular visco supplementation knee injections, this may provide pain relief and positive changes in range of motion without the need of local anesthetic being injected into the joint space.

Eligibility Criteria:
Inclusion Criteria:

* Patients of the BAMC Orthopaedic clinic
* Active duty, dependent and civilians
* Ages 18-65
* Diagnosed with knee osteoarthritis by their Orthopaedic provider
* Determined to be eligible for Sodium Hyaluronate injections by their Orthopaedic provider

Exclusion Criteria:

* Patient without knee osteoarthritis diagnosis
* Patient requiring immediate surgery for their knee complaints
* Patients younger than 18 or older than 65
* Pregnant patients
* Patients without active pain
* Patients with history of knee arthroplasty
* Patients with auricular deformity which would affect BFA
* Patient with history of vasovagal secondary to needles or injections
* Patients with active infection at BFA treatment sites
Evaluation of Metronidazole Hydrogel 25% in Stage II and III Periodontitis

A randomized clinical trial will be performed single-blind to evaluate the effectiveness of sublingual metronidazole hydrogel 25 % in periodontitis.

A randomized clinical trial will be performed single-blind to evaluate the effectiveness of sublingual metronidazole hydrogel 25 % in periodontitis in stage II and III.

At least 40 volunteers between the age of 18 and 80, will be enlisted, with the need to perform the SRP. In half of the mouth will be used the metronidazole hydrogel 25%, while in the other half no drugs will be used of delivered.

The study will be carried out in accordance with the Helsinki Declaration and the Protocol will be submitted to the Internal Review Board of the University to obtain authorization. Afterwards, the protocol will be recorded on the databa-se clinicaltrials.gov for clinical trials.

The protocol respects the SPIRIT parameters for the compilation of protocols on clinical trials and the study will respect the parameters of CONSORT sta-tement on randomized clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* 10% of sites with survey depth 5 mm
* Comparable pockets in 4 mouth quadrants
* Health at systemic level

Exclusion Criteria:

* Changes in oral mucosa
* Depth at the poll 5 mm
* Presence of removable prostheses or orthodontic equipment
* Allergies to even a single component of a product in testing• Antibiotic-based treatments during the 6 months preceding the start of testing
* History of previous periodontal treatments in the 12 months preceding the start of the study
Multimodal Oral Analgesia for Trauma in the Emergency Department

The prevalence of pain in the emergency department is estimated between 60% and 78%. However, many studies reported oligo analgesia in about half of patient admitted to the emergency department. The delay before effective analgesia is one of the main causes of oligoanalgesia. The use of nurse-directed protocol allows the administration of analgesic upon admission to the emergency department. Nevertheless the need of intravenous access may delay analgesia. The use of oral form analgesics even with immediate release does not allow effective analgesia before 20 min. Pain management protocol in the emergency reception desk of CHU Grenoble Alpes (CHUGA) includes paracetamol that can be combined with oxycodone tablets depending on the pain intensity. For any mono traumatized it is possible to associate self-administer methoxyflurane inhaler. The pain management protocol is already used in the emergency reception desk of CHU Grenoble Alpes.The different analgesics( paracetamol,oral oxycodone, methoxyflurane) are already administered as part of routine care.The use of these different analgesics means would allow a rapid and adapted effectiveness to the pain intensity. However, there are no data on the efficacy and acceptability of such an early multimodal analgesia protocol in the emergency department.

200 Patients will be included from 8:00 am to 8:00 pm and will receive a multimodal analgesia under the nurse-directed pain management protocol (paracetamol +/- oral oxycodone +/- methoxyflurane) as part of routine medical care.

The pain will be evaluated (Numerical rating scale) prior to the administration and reassessed by a nurse every 5 minutes for 30 minutes and then at 45min and 1 hour after administration of the pain protocol. Satisfaction of patients and caregivers will also be assessed at the end of care.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients : ≥ 18 year and older
* Trauma pain
* NRS≥ 4
* Non- opposition to participate in the study

Exclusion Criteria:

* Trauma with at least one of the following severity criteria:

  * Suspected (from mechanism) or confirmed multiple trauma
  * State of shock
  * Suspected or proven trauma to the thorax (excluding isolated rib fractures with Spo2 ≥ 98%)
  * Suspected or proven Abdominal trauma
  * Suspected or proven pelvic trauma
  * Severe traumatic brain injury
* Altered level of consciousness (Glasgow score \< 15)
* Patients who took any analgesic within 4 hours prior to admission (except paracetamol)
* Use of nitrous oxide in the hour before admission
* Patient requiring an intravenous access at admission (e.g. : open fracture displaced)
* Hypersensitivity to one of the molecules of the analgesia protocol
* Known pregnant or likely to be pregnant women at the time of inclusion
* Subject in an exclusion period from another study
* Subjects under tutelage or subjects deprived of liberty
* Patients to be unable to understand the purpose of study
A Randomized Trial of Vitamin D Supplementation With or Without Vitamin A in Stem Cell Transplantation

The investigators hypothesize that supplementation with vitamins A and D will reduce the incidence of acute gastrointestinal graft versus host disease (GI GVHD) compared with supplementation with vitamin D alone.

The investigators' preliminary data suggest that low levels of vitamin A directly impact risk of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI) and they believe supplemental vitamin A at the time of hematopoietic stem cell transplantation (HSCT) can reduce the risk of MBI-LCBI and gastrointestinal graft versus host disease (GI GVHD). In addition, the investigators' preliminary data suggest that a significant number of patients requiring HSCT have vitamin D deficiency even prior to transplantation, and that persistent and newly developed deficiency post-HSCT resulted in worse outcomes.

This study is a comparison of vitamin D supplementation comparing a single large dose of vitamin D "stoss therapy" with a placebo in the standard care arm with supplementation with single large doses of both vitamins D and A in the experimental arm. Participants will be randomly assigned to either the standard care arm or the experimental arm.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for allogeneic stem cell transplant
* Vitamin D level \< 50 ng/ml
* Vitamin A level \< 75th centile for age
* Able to tolerate enteral vitamin dose administration

Exclusion Criteria:

* History of pathologic fractures
* Known history of nephrocalcinosis or nephrolithiasis
* Current granulomatous disease
* ALT \> 10X ULN for age prior to administration of vitamin A
* Ongoing raised intracranial pressure
* Pregnancy
To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.

To demonstrate a dose response for 1 mg, 5 mg and 20 mg TID oral sildenafil for the treatment of subjects with PAH.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with PAH (i.e. IPAH or secondary to connective tissue disease or with surgical repair of ASD, VSD, PDA, aorto-pulmonary window) whose baseline six minute walk test distance is \>/= 100 m and \</= 450 m.
* Subjects with a mean pulmonary artery pressure of \>/= 25 mmHg and a pulmonary artery wedge pressure of \</= 15 mmHg at rest via right heart catheterization performed within 12 weeks prior to randomization.

Exclusion Criteria:

* Subjects whose 6 Minute Walk Distance may be limited by conditions other than PAH related dyspnoea or fatigue, e.g. claudication from vascular insufficiency or significant arthritis.
* Subjects who are currently receiving any forms of chronic treatment for PAH such as prostacyclin, PDE-5 inhibitors, endothelin-receptor antagonists, nitrates or nitric oxide donors (e.g. arginine supplement, nicorandil) in any form, protease inhibitors such as ritonavir and saquinavir, ketoconazole, itraconazole, and alpha blockers. Subjects previously receiving any of these drugs must have stopped use for a period of at least 1 month prior to screening, except in the case of bosentan or prostacyclin (3 months).
Safety and Efficacy of the Sore Throat Lozenges to Treat Acute Sore Throats

Aim of this study is to investigate safety and efficacy of A. Vogel Sore throat lozenges for the treatment of of acute sore throats

75 patients aged 12-75 years with acute sore throats (symptoms not older than 48 h) were recruited by the study site/CRO via local general practitioners and are allocated to acute treatment with A. Vogel Sore throat lozenges. The patients who are confirmed to meet the study entry criteria and after having given written informed consent will be assigned to receive a study treatment according to study procedures described in the study plan.

The patients will visit study site twice. At the first visit (Visit 1) a screening will be performed to finally decide if patient will be included/excluded in the study. Then he or she will be taking one single lozenge under supervision of the investigating physician and acute efficacy/safety ratings recorded before intake and repeatedly every 15 minutes for 90 minutes after intake of first lozenge. He or she will be supplied with the remaining 19 lozenges in a bottle and provided with patient diaries for home recording of efficacy/safety. After four days (max 5 days) or until complete resolution of symptoms the patients were obliged to return to the study centre for final visit 2. Daily ratings of efficacy/safety was done by the patient once in the morning and once in the evening. Daily dosage was 5 lozenges per day every 3rd hour during daytime.

At final visit 2, patients will be evaluated physically by the physician at the study centre and again assessed for safety/efficacy parameters. At last, patients returned their patient diaries and remaining study medication before compensation is handed out and patients finally excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 12-75 years
* Acute pharyngitis or tonsillitis with the following symptoms: Sore throat, Inflammation of the pharynx and/or tonsils
* Start of painful disease with the last 48 hours before study inclusion
* Tonsillopharyngitis Score bigger than or equal to 6 (s.attachment)
* Willingness to give blood samples and three viral throat swabs
* Written informed consent

Exclusion Criteria:

* Pharyngitis or tonsillitis more than 48 hours before study start (inclusion)
* Intake of analgetically active medication within the last 12 hours prior to study start (inclusion)
* Use of local sore throat medications within the last 4 hours prior to study start (inclusion)
* Patients with symptoms of a primary bacterial pharyngitis or a bacterial superinfection
* Severe medical condition (tumors, uncontrolled hypertension, heart insufficiency, immunosuppressive diseases etc.)
* Systemic use of corticosteroids in the last month prior to study inclusion
* Allergies to substances used in the tablet
* Pregnancy or lactation
* Participation or inclusion in one or more clinical trials within the last 30 days
Navigated Abdominal Lymph Node Dissections

Image-guided navigation surgery allows for full utilization of pre-operative imaging during surgery, and has the potential of reducing both irradical resections and morbidity. In this study we will randomize patients which will undergo an abdominal lymph node dissection in order to evaluate the actual technical and clinical benefit of navigation

In the study patients will be randomized between the use of a surgical navigation system or not. The operation itself will be performed according to current clinical practice, and the navigation system will be used for better localization and orientation during the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for open abdominal surgery in which targeted removal of one or more pathological lymph nodes is part of the surgical plan

Exclusion Criteria:

* Metal implants in the pelvic area
* Contra-indication for contrast enhanced CT scanning
Noncoding RNAs in COVID-19 and COVID-19 Related Kidney Dysfunction

In this study, critically ill patients with highly suspected or confirmed COVID-19 will be included. Main goal is the identification of noncoding RNAs in COVID-19 associated organ dysfunction with an emphasis on acute kidney injury.


Eligibility Criteria:
Inclusion Criteria:

* COVID-19

Exclusion Criteria:

* kidney transplantation
* eGFR \< 30 ml/Min
* dialysis within last 90 days
* chronic dialysis
* pregnancy
Electronic Nose for Diagnosis of Neurodegenerative Diseases Via Breath Samples

The diagnosis of neurodegenerative conditions and ADHD still mostly relies on clinical symptoms as there are no validated, inexpensive, and simple bio- markers available yet. The purpose of this study is to deliver a proof-of-concept for novel biomarkers to identify neurodegenerative conditions and ADHD based on breath testing.

Alveolar breath will be collected from healthy volunteers, patients with extrapyramidal conditions, patients diagnosed with dementia and from ADHD subjects. The discriminative power of a tailor-made Nanoscale Artificial Nose (™NA-NOSE) containing an array of six nanomaterial-based sensors will be tested. Discriminant factor analysis will be applied to the NA-NOSE signals in order to detect statistically significant differences between the sub-populations, and classification success will be estimated using leave-one-out cross-validation. The identification of NA-NOSE patterns will be supported by analyzing the chemical composition of the breath using gas-chromatography in conjunction with mass-spectrometry (GC-MS).


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with neurodegenerative conditions
* Healthy subjects
* Subjects diagnosed with ADHD
Go/No-Go Intervention for Weight Loss

The purpose of this study is to assess the effect of a food-specific Go/No-Go (GNG) computerized training task on weight loss, food evaluation, and disinhibition in a population of overweight and obese individuals.

Within the current obesogenic environment, the prevalence of overweight and obesity has dramatically increased over the past 40 years. As a result, approximately 40% of Americans attest to being on a diet, with most of these efforts being unsuccessful. Most weight loss diets rely on self-control and reflective thinking (e.g., making conscious food choices multiple times per day), despite the fact that responses to appetitive foods often occur through implicit (unconscious) processes. The proposed study is a randomized clinical trial for weight loss that targets these implicit processes through the use of a computerized, food-specific, go/no-go task. This task has previously resulted in reduced food consumption in laboratory settings, and small but significant weight loss in two brief intervention studies. The purpose of this study is to replicate one prior study and to compare different doses of the intervention. Participants will be assigned to one of three groups: high intensity, low intensity, or active control, and will be assessed on a number of variables pre- and post-intervention. Changes in body weight, food evaluation, frequency of self-reported food consumption, and eating disinhibition scores will be evaluated. It is hypothesized that individuals receiving the food-specific go/no-go training (high intensity and low intensity groups) will experience greater weight loss, decreased disinhibition with food, and reduced snacking of the targeted foods than those in the active control group. It is also hypothesized that the high intensity intervention will be more effective than the low intensity intervention across these variables. Moderators (e.g., dietary restraint, disinhibition) will also be explored throughout this study, along with the mechanism of devaluation of specific foods.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) ≥ 25
* Age ≥ 18
* Consume some of the determined "no-go" snack foods at least three times per week (assessed using a food frequency questionnaire)
* A desire to lose weight

Exclusion Criteria:

* Medical condition limiting dietary intake
* Medical condition directly affecting weight
* Current use of weight loss medication
* Actively enrolled in a formal weight loss program currently or within the past 6 months (e.g., Weight Watchers)
* History of bariatric surgery
* Currently pregnant
* Current smoker
* Smoking cessation within the past year
Diagnosis of Acute Appendicitis: Low-dose Computed Tomography (CT) Versus Standard-dose CT

The purpose of this study is to determine whether low-dose CT is not inferior to standard-dose CT in the rate of unnecessary appendectomy.

Acute appendicitis is a very common disease with the lifetime incidence of 7%. Abdomen CT is an established first-line diagnostic test in patients suspected of having acute appendicitis. Since many individuals suspected of having acute appendicitis are young, with a mean age of 30 years, CT radiation is of particular concern.

The estimated lifetime attributable risk of death from cancer due to the radiation exposure of a single abdomen CT study is 2-7/10,000 for average adults ranging 20-40 years in age.

The purpose of this study is to determine whether low-dose CT is not inferior to standard-dose CT in the negative appendectomy rate.

Eligibility Criteria:
Inclusion Criteria:

* Suspected of having acute appendicitis
* Referred for abdomen CT from Emergency Department

Exclusion Criteria:

* Body mass index \< 18.5 kg/m2 (ultrasonography is favored)
* Intravenous contrast-enhancement is contraindicated