cyrilzakka/clinical-trials huggingface dataset:
The Comparison of Different Administration Routes of Pediatric Premedication

The study purpose is to compare the effect of different Administration Routes of Pediatric Premedication (including oral administration, intramuscular injection, rectal perfusion, intranasal).

In this study, 80 cases of surgical or otolaryngology children undergoing elective surgery were divided into four groups：oral administration group, intramuscular group, rectal infusion group, intranasal group depending on the route of administration before anesthesia. By observing the difference of sedative effects, postoperative recovery, and postoperative psychological behavior among the four groups,compare the effect of four pre-anesthetic administration routes.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent of children's parents;
* Children patient in pediatric surgery and E.N.T. department;
* surgery time 1 \~ 3 hours;
* Aged between 1 and 7 years old;
* American Society of Anesthesiologists (ASA)classification:class I\~II;

Exclusion Criteria:

* With cardiovascular and respiratory complications;
* A history of the endocrine system;
* A long history of application of sedative drugs;
* Water and electrolyte balance disorder preoperatively;
* Liver and kidney dysfunction;
* Nervous system dysfunction;
* High gastrointestinal obstruction;
* Tracheoesophageal fistula, trachea foreign body, hiatal hernia, dysphagia;
* Lung infection, atelectasis;
* Congenital heart disease(CHD);
* Severe malnutrition;
* Traumatic or ischemia anoxic encephalopathy, high cranial pressure;
* Anesthesia and surgery was conducted in 3 days;
Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients

The primary objective of this trial is to determine whether daily treatment with tiotropium (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of decline in lung function over time in patients with COPD.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Male or female patients 40 years of age or older.
* Smoking history of at least 10 pack years.
* Diagnosis of COPD with post bronchodilator FEV1 less than or equal to 70% of predicted normal and FEV1\<70% of FVC and on stable respiratory medication.

Exclusion Criteria:

* Significant diseases other than COPD which in the opinion of the investigator may put the patient at risk or influence the patients ability to participate.
* Myocardial infarction in past 6 months.
* Unstable or life threatening arrhythmia in past year.
* Hospitalization for NYHA heart failure class III or IV in past year.
* Active tuberculosis.
* Asthma.
* Pulmonary resection.
* Malignancy treated with radiation or chemotherapy in past 5 years.
* Respiratory infection in 4 weeks prior to screening.
* Known hypersensitivity to anticholinergic drugs or components.
* Known moderate to severe renal impairment.
* Known narrow angle glaucoma.
* Significant symptomatic BPH or bladder neck obstruction.
* Need for oxygen therapy \>12 hr/day.
* Use of oral corticosteroids at unstable doses or \>10 mg/day.
Efficacy and Safety of RTX-GRT7039 in Adult Subjects With Knee Osteoarthritis

A double-blind, randomized, placebo-controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of repeated injections of RTX-GRT7039 versus placebo in patients who have pain associated with osteoarthritis of the knee despite standard of care.

This trial comprises a total observation period of up to 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* The participant has given written informed consent to participate.
* The participant is 18 years of age or older at the Screening Visit.
* The participant has a diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria and functional capacity class of I to III.
* There is a documented history indicating that participant has insufficient pain relief with previous Standard of Care.

Exclusion Criteria:

* The participant has past joint replacement surgery of the index knee.
* The participant has a history of significant trauma or surgery (e.g., open or arthroscopic) to the index knee within 12 months of Screening.
* The participant has periarticular pain from any cause other than osteoarthritis, including referred pain, bursitis, or tendonitis.
* The participant has clinical hip osteoarthritis on the side of the index knee.
* The participant has pre-existing osteonecrosis, subchondral insufficiency fracture, atrophic osteoarthritis, severe bone on bone osteoarthritis, knee pain attributable to disease other than osteoarthritis, or the participant has rapidly progressing osteoarthritis (RPOA) Type I or Type II.
* The participant has significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the target knee (varus \>10, valgus \>10) by X-ray as assessed by independent Central Readers at Screening Visit.
* The participant has other conditions that could affect trial endpoint assessments of the index knee.
* The participant has current clinically significant disease(s) or condition(s) that may affect efficacy or safety assessments, or any other reason which, in the investigator's opinion, may preclude the participant's participation for the full duration of the trial.
* The participant has a history of hypersensitivity to resiniferatoxin (RTX) or any similar component (capsaicin, chili peppers).
* The participant is currently participating or was participating in another investigational drug trial within 3 months prior to the Screening Visit.
* The participant is an employee of the investigator or trial site, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial site or is a family member of the employees or the investigator.
Applied Relaxation for Vasomotor Symptoms

The objectives of this study are to compare frequency and severity of moderate to severe vasomotor symptoms in postmenopausal women treated with applied relaxation (AR) with an untreated control-group (CG) and to investigate if Health Related Quality of Life improve in the AR-group compared to an untreated CG.To study if salivary cortisol excretion would change within the AR treated group compared with the control group.

Approximately 70% of women in Europe and North America experience hot flashes and night sweats during the climacteric period. Many women abstain from hormonal therapy because of side effects or contraindications such as breast cancer or thrombosis.

Different alternative therapies for alleviation of hot flashes are described in the literature. Both pharmacological treatments, different types of natural remedies, acupuncture, life-style changes and mind-body therapies are suggested as promising therapies. Applied relaxation (AR) is a technique influenced on cognitive behavioral therapy (CBT) using coping mechanism and conditioning. Previous study with healthy postmenopausal women showed promising results on hot flash frequency with an average decrease of more than 70 % with persisting effect three months after therapy and also HRQoL significantly increased probably due to better sleep and diminished vasomotor symptoms. But the method must be further investigated before strong evidence-based conclusion can be drawn.

Cortisol is a potent stress hormone regulated by the hypothalamic-pituitary axis. The factors underlying how alternative treatment works and the mechanism underlying improvements in symptoms are not fully understood.

Eligibility Criteria:
Inclusion Criteria:

* postmenopausal women (at least 12 months since last menstrual bleeding occurred or in previously hysterectomised women a serum follicle-stimulating hormone (S-FSH) defined as postmenopausal level according to references at the local laboratory)
* More or equal to 7 moderate to severe hot flashes or more or equal at 50 hot flashes per week according to a two-week screening diary
* ability to understand and speak Swedish
* freely given informed consent

Exclusion Criteria:

* unstable thyroid or other metabolic disease
* treatment with hormone therapy (HT) or other complementary- or alternative treatments treatment for menopausal-related symptoms
* treatment with psychopharmacological drugs and/or sedatives d-un-treated psychiatric disease
* frequently exercising women (≥ 2h high-intensity activities/week)
A Study to Learn About Study Medicine Called PF-07261271 in Healthy People

The purpose of this clinical trial is to learn about the safety and effects of the study medicine PF-07261271 for the potential treatment of Inflammatory Bowel Disease.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals as determined by medical evaluation
* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).

Exclusion Criteria:

* Clinically significant medical conditions
* History of HIV infection, hepatitis B, or hepatitis C
* BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic)
* Clinically relevant ECG abnormalities
* Previous study drug administration within 30 days or 5 half-lives of first planned dose
* History of drug/alcohol abuse or \>20 cigarettes/day
Study to Assess the Bioavailability, Pharmacokinetics, Safety, and Tolerability of AVP-923 in Healthy Adult Participants

This study will be conducted to evaluate the relative bioavailability, pharmacokinetics, safety, and tolerability of AVP-923 (dextromethorphan hydrobromide \[DM\] and quinidine sulfate \[Q\] capsules) when the contents of a capsule are administered in applesauce or via a nasogastric feeding tube, compared with administration of a capsule in healthy, fasting, adult participants.

This is an open-label, single-center, randomized, single-dose, 3-treatment, 3-period, 6-sequence crossover study in healthy adult participants consisting of approximately 7 weeks of treatment. The study population will be limited to extensive metabolizers of cytochrome P450 (CYP) 2D6.

Approximately 18 participants will be randomly assigned to 1 of 6 sequences (ABC, ACB, BAC, BCA, CAB, CBA).

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults, 18 to 65 years of age, inclusive
* Willing to sign informed consent form
* Cytochrome P450 2D6 genotype that confers extensive metabolizer profile (as per documented phenotype interpretation from local laboratory and approval from Avanir)

Exclusion Criteria:

* History or presence of significant pulmonary, hepatic, renal, hematologic, allergic, endocrine (including diabetes), immunologic, dermatologic, neurologic (including history or presence of seizures or convulsive disorders), psychiatric disease (including history of suicidal ideation or behavior) or any eating disorder deemed clinically significant by the investigator
* History or presence of significant cardiovascular disease, including complete heart block, QT interval corrected for heart rate (QTc) prolongation, and/or torsades de pointes
* History or presence of any gastrointestinal (GI) disease or condition that could compromise participant safety or affect the absorption of study drug, including GI ulcers, GI bleeding, esophageal or gastric varices, and dyspepsia requiring regular (i.e., more frequently than once a month) use of acid-reducing drugs
* Known hypersensitivity/intolerance to dextromethorphan or quinidine
* Participants whom the principal investigator or his delegate deems to be ineligible
Dicloxacillin: Clinical Relevance of Drug-drug Interactions by Induction of Drug Metabolism.

This trial is conducted as a cocktail-study namely an open-label, randomized, two-sequence, two-period crossover, cocktail study where a combination of cocktail-drugs is used to illustrate whether or not, or to what degree dicloxacillin affects the level of activity of the 5 most important CYP enzymes and therefore plays a potentially decisive role in serious drug-drug interactions.

Given knowledge explains dicloxacillin and the drug warfarin to be a potential dangerous drug drug interaction because the effects of warfarin is downregulated to a degree as to where it might cause patients to have thrombotic events.

A potential explanation to this is namely dicloxacillin increases the activity of certain drug metabolising enzymes metabolising warfaring which in turn decreases the concentration of the drug in the blood and the therapeutic effect.

Cocktail study is the golden standard to investigate as to whether there is changes is P450 enzymes as a result of drug-drug interactions.

The cocktail consists of Midazolam, omeprazole, tolbutamide, caffein and dextromethorphan which is well known markers for these enzymes. These markers are safe, have specific (enzyme) metabolism and has been used in several studies with no Serious Adverse reactions reported.

By measuring the Concentration of the drug and its metabolites in plasma / Urine before and after treatment with dicloxacillin we will estimate AUC (area under the curve) and test our hypothesis/primary end point of whether there is change in AUC for Tolbutamide (CYP2C9)

Eligibility Criteria:
Inclusion Criteria:

* Are you in a general healthy condition?; questions asked; Are you healthy in general? 2; Do you have any chronic diseases? 3; Are you taking any medications regularly? 4, Are you taking any medications periodically . 5; Are you taking nutrition supplements, "nature-medicine" or over-the-counter drugs
* BMI; range; 18,5-29,9 kg/m2
* eGFR(estimated glomerular filtration rate), ALAT(alanine aminotransferase), bilirubin, hæmoglobin og HbA1c, should be within normal limits or without clinically significantly deviation from these.
* Non-Smoker

Exclusion Criteria:

* Hypersensitivity to applied medications. Known allergy to penicillin or type 1-reaction to cefalosporins.
* Known allergy to sulfonamides
* Clinically relevant intake of receipt-required medication, over-the-counter medication or nutritional supplements.
* Chronic or daily intake of alcohol.
* Participation in other Intervention-studies
An Evaluation of a Marketed Lubricated Eye Drop in Soft Contact Lens Wearers Who Experience Ocular Dryness

Study to evaluate subjective comfort associated with the use of a marketed lubricant eye drop, by subjects reporting ocular dryness and wearing soft contact lenses on a daily disposable replacement schedule.

The objective of this study is to evaluate subjective comfort associated with the use of a marketed lubricant eye drop, by subjects reporting ocular dryness and wearing soft contact lenses on a daily disposable replacement schedule.

Eligibility Criteria:
Inclusion Criteria:

* Normal eyes

Exclusion Criteria:

* Topical ocular medication use Unstable or active ocular issues
Health Impact of L.Reuteri Consumption in Crew Members of a Naval Ship at Sea

This study is designed to evaluate the impact of the regular consumption of probiotic Lactobacillus reuteri-containing lozenges over a period of 42 days on parameters of oral and general health in crew members of a naval ship at sea.

Probiotic strains of Lactobacillus reuteri have demonstrated a significant impact on the composition of the oral and intestinal microbiome as well as modulating the host response in several clinical trials and in vitro experiments.

This two-arm double blind placebo controlled clinical trial will evaluate the impact of the regular consumption of L.reuteri-containing lozenges over a period of 42 days on parameters of oral and general health in crew members of a naval ship at sea.

2 x 36 healthy study subjects will be recruited from the crew members of the ship.

At baseline and at the end of the study (day 42) the following parameters will be recorded at the Ramfjord teeth (teeth 16, 21, 24, 36, 41, 44):

Bleeding on Probing (BoP) as the primary outcome

Secondary outcomes will be Gingival Index (GI) Plaque Control Record (PCR) Pocket Probing Depth (PPD) Pooled oral and intestinal (stool) microbial samples will be taken at baseline and at the end of the study for the subsequent analysis of the

* composition of the oral microbiome
* composition of the intestinal microbiome by whole genome sequencing

Furthermore the frequency of short-term sick leave due to respiratory or intestinal diseases among the study participants during the observation period will be recorded.

Eligibility Criteria:
Inclusion Criteria:

Minimum of 12 natural teeth

Exclusion Criteria:

Regular intake of antiinflammatory drugs affecting periodontal health (e.g. NSAIDs) Manifestation of systemic disease affecting periodontal health (e.g. diabetes) Use of antiseptic oral mouthrinses Drug/alcohol abuse
The DEXTER-assisted Non-Emergent and Acute cholecyStecTomy Study (The NEST Study)

This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted and laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* Aged \> 18 years
* Patients planned to undergo elective robot-assisted and laparoscopic cholecystectomy; using one camera port, two ports for the manipulating instruments, and additional ports as needed.

Exclusion Criteria:

* Morbidly obese patients (BMI \> 40)
* Any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments
* Need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and microwave energy delivery
* Bleeding diathesis
* Pregnancy
* Patients with pacemakers or internal defibrillators
* Any planned concomitant procedures
* Patient deprived of liberty by administrative or judicial decision
* Participation in another interventional clinical trial
Safety and Clinical Performance of the Yukon Choice PC, Yukon Chrome PC & Yukon Choice Flex Stents in Routine Practice

The goal of this observational study is to collect safety and performance information in the setting of a large-scale clinical registry.

Patients meeting the selection criteria will be included, in chronological order of their implantation. This registry does not require any additional procedures, follow-up interventions, or ionizing radiation for patients.

The inclusion period is planned to last 2 years, starting in Q1 2023. The study will be complete when data on all patient's follow-up for one year have been collected.

* Prospective, observational, noninterventional, multicenter, international clinical registry
* Allocation: consecutively treated patients, non-randomized
* Masking: None (open label)
* Observational model: Longitudinal
* Inclusion period: 2 years
* Follow-up period: at 1 year
* Study duration: 3 years

Patients meeting the selection criteria will be included, in chronological order of their implantation. This registry does not require any additional procedures, follow-up interventions, or ionizing radiation for patients.

The inclusion period is planned to last 2 years, starting in Q1 2023. The study will be complete when data on all patient's follow-up for one year have been collected.

List of visits:

V0: During hospitalization: consultation baseline, data of the intervention and data at discharge

V1: consultation at 30 days Follow-Up

V2: consultation at 12 months Follow-Up

Eligibility Criteria:
Inclusion Criteria:

* Any patient who was implanted only with a Yukon Choice PC, a Yukon Chrome PC or/and a Yukon Choice Flex stent within previous 2 days.
* Patient ≥ 18 years old.
* Male or non-pregnant female patient (Note: females of childbearing potential must have a negative pregnancy test prior to enrollment in the study).

Exclusion Criteria:

* Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
* Co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements or impact the scientific integrity of the trial.
* Concurrent medical condition with a life expectancy of less than 12 months.
Long-Term Specified Drug Use-Results Survey for Xtandi Capsule

The purpose of this study is to confirm the long term safety and efficacy of enzalutamide in patients.


Eligibility Criteria:
Inclusion Criteria:

* no history of treatment with enzalutamide

Exclusion Criteria:

-
Randomised Placebo-controlled Venlafaxine-referenced Study of Efficacy and Safety of 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults

The purpose of this Venlafaxine-referenced study is to evaluate the efficacy, safety and tolerability of two fixed doses of Vortioxetine in the acute treatment of Major Depressive Disorder (MDD).


Eligibility Criteria:
Inclusion Criteria:

* MDE as primary diagnosis according to DSM-IV-TR criteria (classification code 296.xx)
* Current MDE duration of at least 3 months and less than 12 months
* The patient has a MADRS total score \>=30

Exclusion Criteria:

* Any current psychiatric disorder other than MDD as defined in the DSM-IV TR
* Any substance disorder within the previous 6 months
* Female patients of childbearing potential who are not using effective contraception
* Use of any psychoactive medication 2 weeks prior to screening and during the study

Other protocol-defined inclusion and exclusion criteria may apply.
Clinical Significance and Prognostic Value of Prenatal Diagnosis of Obliteration of the Cavum Septum Pellucidum

The aim of this observational study is to evaluate the incidence of the occurrence of additional abnormalities in fetuses diagnosed with cavum septum pellucidum (CSP) obliteration performed at second-trimester ultrasound, as well as to analyze the postnatal neurological outcome.

In cases of failure to visualize the CSP (obliterated or absent) and additional brain anatomical abnormalities, the feto-neonatal prognosis turns out to be mainly related to the type of associated malformation. It is still debated, however, the prognosis of an absent or isolated obliteration of the SPC in the presence of remaining regular brain anatomy for the time.

Very often, the patient is offered fetal brain MRI, which, compared with ultrasonography, appears to be endowed with greater accuracy in identifying any additional associated cerebral animals. In our center, it is a shared custom to routinely offer the patient the option of performing an MRI, in all cases of failure to visualize the SPC.

If obliteration of the CSP is confirmed as isolated, normal clinical practice is to perform monthly ultrasound monitoring and a second MRI at approximately 30 to 32 weeks, with the aim of ruling out the appearance of further developmental abnormalities. In addition, a specialized pediatric evaluation is usually performed after birth with the aim of following the child developmentally.

In a retrospective manner, clinical data of patients followed at our center from 01/01/2024 to 31/05/2021, with a finding of obliteration of the CSP at the second trimester, will be considered. Of these patients, data from the morphologic ultrasound and concomitant neurosonography and subsequent MRI (if performed) will be analyzed, as well as those that emerged during follow-ups performed until the end of pregnancy. For the purpose of assessing the fetal neurological outcome, such patients will be contacted by telephone, the study will be explained to them, and a proposal will be made for a psychiatric examination at the department of child neuropsychiatry for their child. During this visit the child will be administered psycho-aptitude tests routinely used, according to normal clinical practice, in neurodevelopmental assessment, in accordance with the child's age.

If the patients do not agree to have their children undergo this visit, only the analysis of the data collected during the visits, performed during pregnancy, will be done.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant participants with a diagnosis of cavum septum pellucidum obliteration made at second-trimester morphologic ultrasound between 19+0 and 21+6 weeks
* Age \> or = 18 years at the time of outpatient access
* Acquisition of informed consent form, from the patient and minor
* Patients followed at our center

Exclusion Criteria:

* None