cyrilzakka/clinical-trials huggingface dataset:
Standardization of a New Psychophysical Olfactory Test, TODA2

Recruitment of patients consulting the IUFC for another pathology unrelated to an olfactory disorder:

Interview and clinical examination and Passing the 2 olfactory tests for 30 voluntary's patients, a second consultation of 15 minutes including the time of the test within 7 days after the 1st

Recruitment of patients consulting the IUFC for another pathology unrelated to an olfactory disorder (otosclerosis, pre- surgery, tonsillectomy, cosmetic surgery)

Data collection methods: 2 parts (duration approximately 1.5 hours) and for 30 volunteer patients, a second consultation of 15 minutes including the time of the test within 7 days after the 1st:

1. Interview and clinical examination
2. Passage of olfactory tests: TODA2 and Sniffin Stick Test in unirhinal
3. On a voluntary basis, and within a limit of 30 patients, those who agree to come back a second time will be able to benefit from a second pass of the TODA2 on Day 7.

Eligibility Criteria:
Inclusion Criteria:

* Subjects \> 18 years old
* No olfactory complaints; subjective estimation of "normal" olfaction
* Affiliated to the Social Security system
* Signing of informed consent

Exclusion Criteria:

* Parosmia/phantosmia, hyposmia/anosmia, pre-existing subjective dysgeusia/ageusia
* ATCD of sinus or cranial neoplasia
* ATCD of sinus or cranial radiotherapy
* Neurological or neurodegenerative disease
* ATCD of persistent post-viral hyposmia or anosmia (including COVID) (more than 3 months)
Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis

Primary Objective:

* To assess the long term safety of Sarilumab (SAR153191/REGN88) in participants with ankylosing spondylitis (AS)

Secondary Objective:

* To assess the long term efficacy of Sarilumab (SAR153191/REGN88) in participants with AS

The maximum study duration per participant was to be 267 weeks (approximately 5 years) broken down as follows:

* screening up to a maximum of 1 week;
* treatment up to a maximum of 260 weeks;
* follow-up of 6 weeks after treatment discontinuation.

Eligibility Criteria:
Inclusion criteria:

* Participant with AS who participated and completed 12-week treatment in study DRI11073-NCT01061723.

Exclusion criteria:

* Adverse event(s) having lead to treatment discontinuation in the DRI11073 study;
* Event or laboratory abnormality observed at the last treatment visit of DRI11073 study that would have adversely affected participation of the participant in this study as per investigator judgment.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Wait and See Antibiotic Prescription for Acute Otitis Media: A Randomized Controlled Trial

To determine if a wait and see prescription for ear infections in childhood reduces use of antibiotics compared to an immediate prescription

We conducted a randomized, controlled trial evaluating a consecutive series of children diagnosed with AOM during a one year period in an urban pediatric emergency department, utilizing diagnostic recommendations from contemporary evidence-based guidelines. The objectives of the study were to determine whether treatment of AOM using a "Wait and See Prescription" (WASP) significantly reduces use of antimicrobials compared with a "Standard Prescription" (SP) and to evaluate the effects of this intervention on clinical symptoms and adverse outcomes related to antibiotic use.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 6 months - 12 years who were diagnosed with Acute Otitis Media

Exclusion Criteria:

* clinician suspicion or diagnosis of a concurrent bacterial infection
* patient appeared "toxic" as determined by the PEM clinician
* patient was hospitalized
* history of compromised immunity
* patient was treated with antimicrobials in the preceding seven days
* either tympanic membrane was perforated
* myringotomy tubes were present
* uncertain access to medical care
* primary language of the parent or guardian was neither English nor Spanish
* prior enrollment in the study
Early Feeding Versus Conventional Feeding

The goal of this clinical trial is to compare early feeding vs conventional feeding after stoma reversal. The main question it aims to answer are:

• whether it is beneficial to start oral feeding within 12hrs after stoma reversal

Participants will be randomly assigned two groups either early feeding or conventional group


Eligibility Criteria:
Inclusion Criteria:

* having ileostomy
* no peritonitis
* intestinal obstruction

Exclusion Criteria:

* uncontrolled diabetes
* uncontrolled hypertension
* sepsis
Study to Assess Switching to B/F/TAF in Treatment Experienced People With HIV Who Are at Least 65 Years of Age

To assess patient reported treatment satisfaction and medication tolerability in virologically suppressed HIV-1 infected adults who are at least 65 years of age who switch to a bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination regimen.


Eligibility Criteria:
Key Inclusion Criteria:

1. Be at least 65 years of age at the time of signing the informed consent form.
2. Be currently receiving an antiretroviral regimen for ≥ 3 months prior to the screening visit.
3. Have documented plasma HIV-1 RNA \< 50 copies/mL for a minimum of 3 months on current ART regimen.
4. Have a plasma HIV-1 RNA \< 50 copies/mL at screening visit.

Key Exclusion Criteria:

1. Have resistance to tenofovir (K65R/E/N, ≥3 thymidine analogue mutations or T69-insertions), primary INSTI-resistance, or a history of failure on an INSTI-based regimen.
2. Have been treated with B/F/TAF
3. Participants with CrCl \<30 mL/min
4. Known or suspected severe hepatic impairment (Child-Pugh Class C)
MEK162 and RAF265 in Adult Patients With Advanced Solid Tumors Harboring RAS or BRAFV600E Mutations

This is a multi- center, open-label, dose finding, Phase Ib study to be conducted in two stages: a dose escalation part to determine the maximum tolerated dose (MTD) safety and tolerability of concurrent administration of MEK162 and RAF265, followed by an expansion part to further assess the safety and preliminary anti-tumor efficacy of this oral combination within two separate patient populations: i) patients with advanced solid tumors harboring BRAFV600E mutations or ii) patients with advanced solid tumors harboring RAS mutations.


Eligibility Criteria:
Inclusion Criteria:

Patients with histologically or cytologically confirmed and non-resectable advanced solid tumors for which no further effective standard therapy exists.

* The patients' tumors must contain documented activating somatic BRAFV600E\* , NRAS or KRAS mutations (except for pancreatic cancer)
* All patients enrolled MUST provide fresh or archival tumor samples at baseline to enable central confirmation of BRAF or KRAS/NRAS mutations
* Measurable, or non-measurable but evaluable disease as determined by RECIST
* Adequate bone marrow function
* Adequate hepatic and renal function
* Adequate cardiovascular function
* Negative serum β HCG test (female patients of childbearing potential only) within 72 hrs prior to first dose

Exclusion Criteria:

* Patients with a history of primary central nervous system tumors or brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases
* Current evidence of retinal disease; or ophthalmopathy as assessed by ophthalmologic examination at baseline that would be considered a risk factor for CSR/RVO (e.g., optic disc cupping, visual field defects, IOP \> 21 mm Hg)
* Impaired cardio-/vascular function or clinically significant cardiovascular diseases, including any of the following:

  * History/evidence of acute coronary syndromes (including MI, unstable angina, CABG, coronary angioplasty, or stenting) ≤ 6 months prior to starting study drugs
  * Thromboembolic event (DVT, CVA, PE) ≤ 6 months prior to starting study
  * Symptomatic CHF, history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality
  * Uncontrolled arterial hypertension, defined as BP \> 140/100 mmHg (average of 3 consecutive readings)
* History of melena, hematemesis or hemoptysis within the last 3 months
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5 mIU/mL)

Other protocol-defined inclusion/exclusion criteria may apply
Effect of Gastric Bypass on the Absorption of Metformin

Background: Gastric bypass is the most commonly performed type of bariatric (obesity) surgery, has dramatically increased in popularity and is now considered to be preferred treatments in severely obese patients that fail non-surgical therapy - particularly in patients with type 2 diabetes. Drug malabsorption is a potential concern post-gastric bypass because intestinal length is reduced.

Purpose: The purpose of this controlled, pharmacokinetic study is to determine whether the absorption of a single dose of metformin, the first line drug treatment in patients with type 2 diabetes, is significantly reduced after gastric bypass.

Methods: A single dose of standard release metformin 1000 mg will be administered to patients who have undergone gastric bypass and to patients who have not received surgery but are on the wait list (wait-listed controls). Blood sampling and urine sampling will occur in standardized fashion over the ensuing 24 hours to measure and compare the absorption of metformin between study arms. 34 patients total will be recruited.

Significance: Following completion of this study, we will better understand how gastric bypass affects metformin absorption. Ultimately, this information will help to ensure that this patient population is receiving optimal doses of this important drug treatment.


Eligibility Criteria:
Inclusion Criteria:

Patients living within and around Edmonton that have been referred to the Alberta Health Services Weight Wise Program

Exclusion Criteria:

1. Undergone or undergoing revision of a previous bariatric procedure
2. Any major post-operative gastrointestinal complications, such as an anastomotic leak, outlet obstruction or persistent vomiting
3. Currently on metformin therapy
4. Any contraindications to metformin therapy such as:

   1. allergy to the drug
   2. chronic metabolic acidosis
   3. history of lactic acidosis
   4. liver failure or baseline liver enzymes higher than 3-fold above the upper limit of normal
   5. congestive heart failure
   6. renal failure (glomerular filtration rate \< 60 ml/min)
   7. alcoholism
   8. acute illness
   9. fatty liver disease
5. Pregnant or nursing
6. Not taking furosemide or nifedipine (both drugs may increase metformin absorption by 15-20%)the day of visit 2.
7. Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the study protocol
Erector Spinae Plane Blockade in Pediatric Scoliosis Surgery Patients

Providing effective analgesia after spinal fusion for idiopathic scoliosis remains a challenge with significant practice variation existing among high volume spine surgery centers. Even in the era of multimodal analgesia, opioids are the primary analgesics used for pain control after pediatric scoliosis surgery, but have multiple known adverse effects. The erector spinae plane block (ESPB) is a newly described fascial plane block performed by injecting local anesthetic between the erector spinae muscle and the transverse process. Additionally, there are case reports describing the ESPB as part of a multi-modal analgesic plan in adult degenerative spine surgery as well as adult spinal deformity surgery, demonstrating effective analgesia and no clinical motor blockade. Although it is known that the inflammatory reaction plays a crucial role in the mechanism of acute pain after major surgery, the effectiveness of the current regional approach on inflammatory response is not well studied.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* Diagnosed with Idiopathic scoliosis
* Undergoing single-stage posterior spinal instrumentation and fusion

Exclusion Criteria:

* Thorascopic tethering procedure
* Two-stage procedure
* Abnormal developmental profile
* Congenital/neuromuscular scoliosis
* Requiring PICU admission
* Known allergy to lidocaine
* Known cardiac, renal or liver disease or dysfunction
* Pre-existing pain complaints, i.e. on regular analgesic medications
* Current psychiatric diagnosis, e.g. anxiety, depression, eating disorder, defined according to DSM criteria.
* Requiring non-standard post-op pain management
* Any history of seizures
* Unplanned staged procedure
* Weight \< 5th centile or \> 85th centile for age
* Porphyria
GLPG0492 Pharmacodynamics

GLPG0492 is a selective androgen receptor modulator: the compound should help protect against (or help restore) muscle loss in case of immobilization (e.g. after orthopedic surgery) or due to aging (androgenic effect), but without anabolic effects (e.g. effect on testosterone). In the first part of the current study it will be tested whether GLPG0492 given orally to healthy male volunteers increases the protein synthesis in muscle, as measured by the uptake into the muscle of intravenously infused phenylalanine.

In the second part of the study, the effect of the compound on the "hormone household" in healthy, postmenopausal women will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male, age 18-50 years (for part 1), and postmenopausal subjects age 35-65 years (for part 2)
* Body mass index (BMI) between 18-30 kg/m², inclusive.
* For men: normal values of testosterone (175-781 ng/dL) and LH (1.24-8.62 U/L).
* Women must be postmenopausal for at least 2 years with postmenopausal FSH level according to the local lab (+negative pregnancy test at screening \& admission).

Exclusion Criteria:

* smoking
* drug or alcohol abuse
* hypersensitivity to any of the ingredients of the study drug
Role of Oral Lactoferrin in Prevention of Recurnt Bacterial Vaginosis in Pregnancy

lactoferrin is believed to modulate immunity and help in prevention of recurrent bacterial vaginosis.In this study, the role of lactoferrin is assessed during third trimester of pregnancy.

This study will be conducted at Zagazig University Hospitals, Obestetrics and Gynecology department, Zagazig University ,outpatient clinic .Assuming the cure rate was 70.8% vs 33.3% in intervention vs placebo group. At 80% power and 95 % CI, the estimated sample will be 66 cases, 33 cases in each group.

Among enrolled women those who have symptome of bacterial vaginosis will be treated with standard antibiotic therapy (metronidazole 500 mg twice daily for 7 days) and women who have history of recurrent bacterial vaginosis randomly assigned to one of two study arms: study grop receiving lactoferrin (2 capsules/day for 5 days followed by further 10 consecutive days at the dosage of 1 capsule/day) by oral intake.(pravotinR).

And another group not reciving lactoferrin.(control group) During follow-up period, all women ingested 1 capsule of lactoferrin or placebo per day, for 10 consecutive days per month.(study group) .

- All participating women attended 3 visits (from T0 to T2) at the gynaecologic centres at recruitment (T0), swap will be repeated after one month (T1) and two months (T2). In each clinical examination, 2 vaginal swabs (for vaginal culture and Nugent score) will be collected. During the first visit (baseline), patient medical history was recorded, informed consent was signed and women were allocated into the two study arms. - The evaluation of efficacy is based on clinical cure rate of BV symptoms (defined as absence of vaginal discharge or itching), microbiological cure rate (defined as remission and vaginal microbiota improvement by restoration of healthy Nugent score with range 0-3), and overall cure rate (absence of symptoms and Nugent score \<7). In addition, recurrence rate was calculated for both groups as percentage of women presenting with symptoms and Nugent score more than 3 during the follow-up period. Safety is assessed by recording all side effects (i.e. adverse events, serious adverse events, and suspected unexpected serious adverse reactions). An adverse event is considered severe if it was fatal, life threatening, required hospitalisation, or led to permanent injury.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women of age group 20-37 years.
2. Primigravida.
3. 28-40 week gestation.
4. History of receurent bacterial vaginosis .

Exclusion Criteria:

1. Multiple gestations.
2. Multiparity.
3. Medical disorders as:

   * Diabetes mellitus.
   * Chronic hypertension.
   * Endocrinal diseases.
   * Autoimmune diseases.
   * Renal diseases.
   * Blood diseases.
4. Allergy to lactoferrin .
Care Bundle and Acute Kidney Injury Progression

The goal of this clinical interventional study is to learn about the effect of implementing a care bundle in the progression of acute kidney injury (AKI) in critical patients. The main questions it aims to answer are:

* What is the impact of care bundle in AKI progression?
* Some improvement of care bundle adhesion rate through an electronic alert can be achieved?

Participants will be adults and critical patients with AKI. During observational study the incidence and progression of AKI will be measured, as well spontaneous care bundle adhesion by medical team. In the interventional study, the progression rate of AKI influenced by care bundle will be measured, as well the adhesion of care bundle through an electronic alert inserted in the patient's daily medical record.

This is a clinical, multicentric and prospective trial (study type: "before" and "after"). Patients aged ≥18 years, admitted to clinical and surgical intensive care units (ICUs) will be included according to selection criteria.

During observational and interventional studies clinical and laboratorial information from electronic medical records will be registered. AKI diagnosis and classification will be based on serum creatinine levels according to kidney disease improving global outcomes (KDIGO) criteria.

The observational study will be carried out to measure the incidence of AKI KDIGO 1 and its progression rate, in order to estimate sample size for the interventional study. Researchers assumed a 10% to 20% reduction in the progression of AKI KDIGO 1 to more advanced stages after the implementation of the care bundle. In the interventional study, the care bundle will be included in the medical records of each individual who develops AKI KDIGO 1. Patients included in this study will be followed by 7 days from inclusion. Adhesion rate to the care bundle will be measured between observational and interventional studies.

Eligibility Criteria:
Inclusion Criteria:

* Patients with recent ICU admission (≤ 48 hours)
* Patients without AKI or with AKI KDIGO 1 at the time of admission

Exclusion Criteria:

* Patients with chronic kidney disease, stage 4 to 5D
* Patients with kidney transplant
* Patients with AKI KDIGO 2, 3 or on dialysis at the time of inclusion in the study
Evaluation of Proteome Multimarker Panel With Multiple Reaction Monitoring as a Surveillance for Hepatocellular Carcinoma

Most current guidelines recommend hepatocellular carcinoma (HCC) surveillance with ultrasound and alpha feto-protein (AFP) every 6 months for individuals with risk factors. However, the sensitivity of ultrasound for HCC detection is significantly reduced, especially in high-risk cirrhotic patients. In this study, the investigators aim to evaluate the efficacy of multiple reaction monitoring (MRM)-based multimarker panel as a surveillance tool for HCC. During two surveillance periods (starting from the time of voluntary consent and 6 months later), participants receive ultrasound, AFP, and MRM-based multimarker panel analysis. Patients who are suspected of HCC based on one of three tests undergo a contrast-enhanced CT scan within 6 weeks. After 6 months from the second surveillance period, the investigators re-evaluate the development of HCC using contrast-enhanced CT and AFP. The diagnostic accuracy of MRM-based multimarker panel is compared to ultrasound and AFP.


Eligibility Criteria:
Inclusion Criteria:

* Patients with liver cirrhosis aged over 18 years, who receive regular surveillance for hepatocellular carcinoma.
* Patients with Risk Index greater than 2.33, corresponding to the annual 5% risk of hepatocellular carcinoma development.

  * Risk Index = 1.65 (if the prothrombin activity was ≤ 75%) + 1.41 (if the age was 55 years or older) + 0.92 (if the platelet count was \< 75 X103/mm3) + 0.74 (if the presence of anti-hepatitis C virus was positive).

Exclusion Criteria:

* History of malignancy diagnosis including hepatocellular carcinoma
* Impaired renal function (Estimated glomerular filtration rate \<30 mL/min/1.73m2)
* Impaired hepatic function (Child-Pugh class C)
* Patients who are not eligible for voluntary consent
Sacral Erector Spinae Block for Pilonidal Sinus Surgery

The incidence of pilonidal sinus disease (PD) is estimated to be around 26/100,000 individuals mostly men.PD can cause the development of abscess or a draining sinus tract and that may lead to a loss of productive power and long-term morbidity.Different surgical technique approaches were proposed for treatment with different rates of success.

Sacral erector spinae plane block was first described by Tulgar et al. To provide sensory blockade in the parasacral region in two cases who had pilonidal sinus surgeries. Since then, the block was used for multiple surgeries like anorecatal, hip surgery and parasacral reconstructive surgeries.After obtaining the ethical committee approval from Menoufia University. patients scheduled for pilonidal sinus surgery will be randomly allocated into one of two groups Patients will be randomized to a study group using a computer-generated random number table, and the allocation concealment will be performed using a sealed envelope technique.The sealed opaque envelopes will be kept locked in dedicated research safe and will be accessed by a research coordinator only when a patient consented for the study. The anesthetist will perform the intervention with the doses and concentration of drugs as per the protocol.

The patients and the follow up researcher will be blinded to the type of intervention used. The patient follow-up time will be scheduled intraoperatively PACU, 1 hour and 24hours postoperatively. The anesthetist who did the intervention will have no access to the reported documents or contact with the patient postoperatively.

For induction of anesthesia all patients will receive medication as per the facility protocol where propofol 1-2mg/Kg, fentanyl 2μg/Kg (actual BW), rocuronium 0.5 mg/kg will be used for induction and an endotracheal tube intubation will be inserted to secure the airway. After intubation and confirmation of endotracheal tube placement by auscultation and capnography, the patient will be turned into prone position.

Maintenance of anesthesia will be maintained by sevoflurane 1-1.2 MAC and rocuronium 0.1mg/kg guided by the TOF. All patients will receive multimodal analgesia in the form of paracetamol 1gm and parecoxib 40 mg (Pizer manufacturing Belgium). After exclusion of other causes of tachycardia and hypertension Morphine 2mg increments will be administrated to keep the heart rate or blood pressure within 20 percent of the patient's baseline parameters.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* ASA physical status 1-3

Exclusion Criteria:

1. ASA \>3
2. Opioid use within the previous 3 months
3. Deranged coagulation parameters
4. Patient refusal
5. Allergy to local anesthetic medication.
6. Preoperative neurological deficits