cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic Study of Fentanyl 400 µg Sublingual Spray, Actiq® 400 µg Transmucosally, and Fentanyl Citrate Injection 100 µg Intravenously (iv)

The objective of this study was to compare the rate of absorption and bioavailability of fentanyl 400 µg sublingual spray, Actiq® 400 µg transmucosally, and fentanyl citrate injection 100 µg intravenously.

This was a Phase I, single-dose, open-label, randomized, 3-period, 3-treatment cross over study in which 21 healthy subjects received single doses of fentanyl 400 µg sublingual spray, Actiq® 400 µg transmucosally, and fentanyl citrate injection 100 µg intravenously following a 10-hour overnight fast. There was a 7 day washout period between treatments.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-breast-feeding female between the ages of 18-55 inclusive.
* Body Mass Index (BMI) between 18-30 kg/m\^2, inclusive, and body weight of at least 60 kg (132 lbs).
* Subject was healthy according to the medical history, laboratory results, and physical examination.

Exclusion Criteria:

* Had a presence or history of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition which, in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
* Had a clinically significant abnormal finding on the physical exam, medical history, electrocardiogram (ECG), or clinical laboratory results at screening.
* Had a significant history of hypersensitivity to opioid analgesics, fentanyl or any related products, naltrexone, or severe hypersensitivity reactions (like angioedema) to any drugs.
* Had a significantly abnormal diet during the 4 weeks preceding the first dose of study medication.
* Had donated blood or plasma within 30 days prior to the first dose of study medication or during the course of this study.
* Had participated in another clinical trial within 30 days prior to the first dose of study medication or during the course of this study.
* Had used any over-the-counter (OTC) medication, including nutritional supplements, within 7 days prior to the first dose of study medication or during the course of this study.
* Had used any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 14 days prior to the first dose of study medication or during the course of this study.
* Had used enzyme altering drugs such as barbiturates, corticosteroids, phenothiazines, cimetidine, carbamazepine, etc, within 30 days prior to the first dose of study medication or during the course of this study.
* Had used opioid analgesics within the last 30 days.
The Early Diagnosis and Warning Role of Erectile Dysfunction

1. Find the early diagnostic markers of erectile dysfunction;
2. Study the warning role of ED in some diseases.


Eligibility Criteria:
Inclusion Criteria:

1. Male and at least 18 years of age.
2. Provide signed informed consent.
3. Have a history of erectile dysfunction (ED: defined as a consistent change in the quality of erection that adversely affects the subject's satisfaction with sexual intercourse) .
4. Have a stable monogamous relationship with a female partner. To some subjects with poor sexual experience, re-evaluation would be conducted after a 4-weeks sex education.
5. Make at least four sexual intercourse attempts with the female sexual study partner during the 4-week therapeutic period without medication.
6. Agree not to use any other ED treatment for at least 4 weeks.

Exclusion Criteria:

1. severe diseases (such as congestive heart failure, arrhythmia, significant renal or hepatic dysfunction and anemia);
2. Had clinically noteworthy penile deformities, pelvic surgery or trauma of perineal region;
3. Had received long-term pharmacotherapy (including antioxidant agents, vitamins and traditional Chinese drugs).
4. An addiction problem (with a history of injection or administration of opium, poppy, heroin, hemp, morphine, cocaine, caffeine, ketamine and meperidine etc.)
Study Comparing the Effects of Esomeprazole Adminstered Orally and Intravenously on Basal and Pentrigastrin-stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)

The purpose of this study is to examine the effects of Nexium at a dose of 40mg administered orally compared to intravenously on the maximum acid output in subjects with symptoms of Gastroesophageal reflux disease (GERD).


Eligibility Criteria:
Inclusion Criteria:

* Heartburn on 2 out of the last 7 days prior to screening or a diagnosis of GERD (with or without a diagnosis of Erosive eosphagitis).
* Body Mass Index within the limits specified in the protocol

Exclusion Criteria:

* History of esophageal, duodenal or gastric surgery
* History of severe liver disease.
* Any other significant disease or pathology judged to be clinically significant by the investigator
Quality of Life in Patients That Undergo J Pouch or Side to End Coloanal Anastomosis for Rectal Cancer

The investigators hypothesis is that the patients who receive a side to end anastomosis have bowel outcome and quality of life that is equivalent to those who receive a J pouch.

The side to end anastomosis has become popular in recent years as it is technically simple to construct. The difference between the Baker type(side to end) of anastomosis and the J pouch, is that no formal pouch is constructed in the side to end. It has one staple line and the anastomosis.

The investigators hypothesis is that the patients who receive a side to end anastomosis have bowel outcome and quality of life that is equivalent to those who receive a J pouch.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with distal rectal cancers who will be having an abdominal proctocolectomy with a low colorectal anastomosis within 4 cm of the dentate line or a coloanal anastomosis will be candidates for this study.
2. No evidence of distant metastatsis -

Exclusion Criteria: Stage IV rectal cancer

1. History of radiation to the pelvis ( eg. for uterine or prostatic cancer)
2. Evidence of synchronus or metachronus disease
3. H/o dementia
4. Prisoners
5. Women who are pregnant
6. History of previous Right Colectomy
7. History of inflammatory bowel disease -
Upper Gastrointestinal Perforations: a Nationwide Registry-based Study

The primary aim of this project is to increase the knowledge about how perforations in the esophagus, stomach and small intestine are treated on a national level. Furthermore, secondary aims include assessment of how different treatment options and type of treating facilities relate to patient survival. This will be done by studying information about all adult patients with an upper GI perforation treated in Sweden during 2005-2023.


Eligibility Criteria:
Inclusion Criteria:

* age of at least 18 years
* perforation in either oesophagus, stomach or small intestine
* treatment carried out in Sweden
* diagnosis set between January 2005 and August 2023

Exclusion Criteria:

* children
Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses

The purpose of this study is to test the hypothesis that dietary n-3 PUFA will have a beneficial effect on systemic and local markers of inflammation when combined with traditional, non-surgical periodontal therapy.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age, male or female
2. At least 20 natural teeth present at the time of periodontal examination
3. Be diagnosed with severe, chronic periodontitis;
4. Be willing to participate in the study

Exclusion Criteria:

1. \<18 years of age
2. Less than 20 natural teeth present at time of periodontal examination
3. Unable or unwilling to provide informed consent or follow study protocol
4. Systemic conditions including diabetes mellitus and any cardiovascular condition that would require premedication prior to dental treatment
5. Use of systemic antibiotics within the last 3 months
6. Pregnancy as diagnosed by administered pregnancy test.
7. You are nursing a baby.
8. Are allergic to fish or fish products.
9. You are taking any other medications, such as dietary supplements, that could affect the outcome of the study
Aquatic Therapy and Autism Spectrum Disorders

To compare the efficacy of one-on-one versus group-based aquatic therapy on the social interactions, behaviors and physical activities of children with autism spectrum disorders (ASDs).


Eligibility Criteria:
Eligibility criteria:

* DSM-V diagnosis of Autism Spectrum Disorder or DSM-IV diagnosis of Asperger's syndrome or high functioning atypical autism or pervasive development disorder - not otherwise specified or else the typical clinical findings and suspicion of an ASD
* Treatment naïve to prior aquatic therapy

Exclusion criteria:

* Not willing to undergo an investigational treatment
* Unable to cooperate well enough to safely participate in aquatic therapy under the protocol guidelines
* Known allergies to pool chemicals
* Other significant co-morbidities which may include (but is not limited to): severe cerebral palsy with low motor function, advanced pulmonary disease, home oxygen requirement, spina bifida with low motor function, permanent feeding tubes, poorly controlled seizure disorder, chronic indwelling urinary catheters or any condition causing severe cognitive impairment
Description of the Immune Response to Yellow Fever Vaccination

Vaccine protection depends on a specific adaptive immune memory. However, a little-explored aspect of certain live vaccines may provide beneficial, non-specific protection against infections or pathogens other than the one from which the vaccine is derived. This is the concept of innate immune memory or " trained immunity", which differs from adaptive memory in its non-specificity. Innate immune memory is triggered by exposure to immunostimulants, and offers protection against unrelated pathogenic threats for several months or even years.

The project aims to carry out an exploratory study to observe, in the context of current practice, the immune response obtained after a subunit and a live attenuated vaccine

Vaccine protection depends on a specific adaptive immune memory. However, a little-explored aspect of certain live vaccines may provide beneficial, non-specific protection against infections or pathogens other than the one from which the vaccine is derived. This is the concept of innate immune memory or " trained immunity", which differs from adaptive memory in its non-specificity. Innate immune memory is triggered by exposure to immunostimulants, and offers protection against unrelated pathogenic threats for several months or even years.

For example, research has shown that the live attenuated BCG vaccine induce non-specific trained immunity, enabling innate immune cells to remember their first encounter and improve their immune status during a second confrontation with similar or different agents.

Other currently available live vaccines, such as BCG , could also "train" innate immune cells.

The project aims to carry out an exploratory study to observe, in the context of current practice, the immune response obtained after a subunit and a live attenuated vaccine

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65
* Referred for immunisation against yellow fever and typhoid
* Any person with indication for the following vaccinations :
* Yellow fever
* Typhoïd
* Whose vaccination schedule includes two appointments 7 days apart
* Whose state of health is compatible with a single 51 ml blood sample collection
* Have consented to participate in the Ivory2 study
* Benefiting from a Social Security plan or equivalent

Exclusion Criteria:

* Anyone with a contraindication to yellow fever and/or typhoid vaccination.
* Any person who has been vaccinated against yellow fever and/or typhoid.
* Anyone who has lived in an endemic area (≥ 1 year) and/or has a history of Typhoid.
* Anyone who is unable to attend the visit 1-month after the typhoid vaccine injection.
* Women claiming to be pregnant or breast-feeding
* Anyone unable to give informed consent for participation
A Swedish Questionnaire Study to Investigate the Perception of Menstrual Bleedings

This field based, questionnaire study will document observational data on womens perception of menstrual bleeding in a cross-section of women in Sweden. Each subject will complete the questionnaire at one occasion.


Eligibility Criteria:
Inclusion Criteria:

* All women 40-45 years available in the web-panel of SIFO
* Completion of the web-based questionnaire

Exclusion Criteria:

* None
Robot Based Gait Training Therapy for Pediatric Population With Cerebral Palsy Using the CPWalker

This trial is being conducted to determine if the CPWalker can be used as a gait training intervention for pediatric patients with gait impairments due to cerebral palsy

Objectives:

1. To determine the use of the CPWalker rehabilitation platform, a robotic device composed by an exoskeleton linked to a walker that provides support and balance, as a gait training intervention in the pediatric cerebral palsy population.
2. To create and define detailed guidelines consisting of robotic based treatment methods for gait rehabilitation.

Hypothesis:

1. CPWalker can be used as a gait training intervention for pediatric patients with gait impairments due to cerebral palsy
2. Performing lower limb training in conjunction with active head and trunk control therapies will improve functional gait levels
3. Following 16-24 CPWalker training sessions, persons with cerebral palsy will show improvements in functional mobility when comparing pre-training measurements to post-training measurements

Procedures:

Participants will engage in an 8-week training program, consisting of 2-3 sessions per week based on the level of gait impairment. Percentage range of motion (ROM), partial body weight support (PWBS), and gait velocity are the principal parameters under variation during training.

Additionally, screening, baseline and post-training testing sessions will be conducted

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Cerebral Palsy with spastic diplegia
* Gross Motor Function Classification System score of 2-4
* Age 11-21 at time of enrollment
* Maximum weight of 75kg
* Height range of approximately 110cm to 170cm
* Ability to understand and follow verbal cues
* Lower limb measurements meet specifications of CPWalker
* Cognition sufficient to communicate pain or discomfort and follow one step direction from the investigator

Exclusion Criteria:

* Any orthopedic surgeries less than 3 months prior to study enrollment or ongoing botox injections
* Severe musculoskeletal deformities affecting safe and comfortable fit into the exoskeleton as determined by the investigator. Patients may be able to wear their AFOs in the CPWalker if it allows for safe fit.
* Unhealed wounds/lesions
* Critical motor control alterations such as dystonia, choreoathetosis, or ataxia
* Aggressive or self-harming behavior
* Severe cognitive impairments that prevent a subject from being able to understand the exercises an/or interact with the study staff
Bioresorbable Vascular Scaffold in Patients With Myocardial Infarction

Evaluation of the feasibility and safety of Bioresorbable Vascular Scaffold (BVS) in patient treated with primary PCI (pPCI).

Background. Drug-eluting stent (DES) implantation may offer benefits in terms of repeat revascularization in patients with ST elevation myocardial infarction (STEMI). The everolimus eluting bioresorbable vascular scaffold (BVS) has shown efficacy and safety in stable patient but not in acute coronary syndromes. The study tested the feasibility and safety of BVS in patient treated with primary PCI (pPCI) Methods. Consecutive STEMI patients admitted within 12 hours of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-hour primary PCI capability will be randomly assigned to everolimus eluting stent (EES) or BVS. Primary endpoints are procedural and clinical success. The MACE (cardiac death, non fatal myocardial infarction, target lesion revascularization (TLR)) and definite or probable ST will be evaluated at six months.

Eligibility Criteria:
Inclusion Criteria:

1. chest pain for more than 30 minutes;
2. ST-segment elevation of 1 mm or more in 2 or more contiguous electrocardiograph leads or with presumably new left bundle-branch block

Exclusion Criteria:

1. Active internal bleeding or a history of bleeding diathesis within the previous 30 days;
2. Contraindication to dual antiplatelet therapy for 12 months;
3. Known allergy to everolimus;
4. A history of stroke within 30 days or any history of hemorrhagic stroke;
5. History, symptoms, or findings suggestive of aortic dissection;
6. High-likelihood of death within BVS resorbtion time;
7. Cardiogenic shock;
8. Infarct artery reference diameter, \<2.0 mm or \>3.7 mm (i.e. not suitable for currently available BVS sizes);
9. Pregnancy;
10. Participation in other trials
Gastrocinemius Function Massage on Lower Extemity Spasticity

This study aimed to investigate gastrocinemius function massage on physical parameters of stroke patients.

Gastrocinemius function massage is known to relieve pain and increase range of motion. However, its effects on spasticity and physical performance in stroke patients are not fully understood. In this study, we aimed to investigate the effects of gastrocinemius function massage.

Eligibility Criteria:
Inclusion Criteria:

* having experienced a stroke at least 6 months prior,
* being able to stand independently for at least 1 minute,
* scoring at least 23 on the Standardised Mini-Mental State Examination (SMMSE), indicating no significant cognitive impairment , and
* having lower extremity spasticity rated between 1-3 on the modified Asworth scale
* at least 18 years of age.

Exclusion Criteria:

* comorbidities such as neurological, orthopaedic, metabolic, and rheumatological diseases that could potentially impact soft tissues.
* patients who had received spasticity or other treatments that could affect soft tissues within the past 3 months,
* those with lower extremity injuries, and those with a diagnosis of cancer or who were pregnant.
Artificial Intelligence Satisfaction in Professionals and Patients

This multicenter cluster-randomized study evaluates the impact of an artificial intelligence (AI) tool on the satisfaction of healthcare professionals and patients in outpatient consultations, measuring its effect on perceived satisfaction (through a visual analog scale), the duration of consultations, and the quality and quantity of clinical data recorded. Adult patients (18-80 years) seen in outpatient centers will participate, comparing those using the AI tool with centers following the usual procedure. The tool is expected to reduce the administrative burden, improve user satisfaction and increase the efficiency and quality of the clinical registry. Recruitment will take place between December 2024 and May 2025, with final analysis planned for the end of 2025.

This multicenter cluster-randomized study aims to evaluate the impact of an artificial intelligence (AI) tool designed to optimize real-time clinical registration during outpatient consultations. Its effect on patient and healthcare professional satisfaction will be analyzed, measured using a visual analog scale (VAS) and validated tools such as the Patient Experience Questionnaire (PEQ) and the Net Promoter Score (NPS). In addition, the duration of consultations and the quantity and quality of clinical data recorded in the intervention and control groups will be compared. The intervention group will use the AI tool, while the control group will continue with the usual recording without AI. Participants will be adult patients (18-80 years) seen in health centers linked to the study, recruited by prior informed consent. AI is expected to reduce the administrative burden on professionals, allowing them to devote more time to direct care, improving both the quality of the clinical record and the patient experience. Recruitment will take place between December 2024 and May 2025, and will follow the ethical guidelines set out in the Declaration of Helsinki. This project seeks to provide evidence on the implementation of AI-based technologies in the outpatient setting and their impact on the quality of healthcare.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 80 years of age.
* Patients consulting for any health reason in the outpatient clinics of the centers participating in the study.
* Patients who sign the informed consent to participate in the study.

Exclusion Criteria:

* Patients who are unable to understand or complete the questionnaires, due to:
* Language barriers.
* Cognitive disabilities.
* Any other reason that prevents their adequate participation.
* Patients who are currently participating in other clinical trials or research studies that may interfere with the results of this study.
Investigation Of Two Different İnterventions İn Hemiplegic Patients

Background: Our study aims to determine the effect of relaxation and breathing exercises in addition to the treatment procedure on depression level, sleep quality, and spasticity in hemiplegic patients.

Methods: Thirty patients aged 40-70 years diagnosed with hemiplegia were included in the study. All patients received the same Bobath exercise three days a week for six weeks. Patients in Group 2 additionally received breathing and relaxation exercises. Sleep quality assessment by Pittsburgh Sleep Quality Index (PUKI), depression by Hospital Anxiety and Depression Scale (HADS), and spasticity by Modified Ashworth scale (MAS) were used. All assessments were made at baseline and six weeks after exercise treatments.


Eligibility Criteria:
Inclusion Criteria:

* The study included patients who met the following inclusion criteria:
* having had a stroke at least six months ago,
* possessing adequate cognitive functions,
* having no pre-existing sleep problems before the disease,
* absence of emotional disturbance prior to the disease,
* voluntary participation in the study,
* no cardiovascular problems,
* having a score of 1, 1+, or two according to the modified Ashworth Scale

Exclusion Criteria:

* having a traumatic stroke caused by malignancy or other organic factors, alcohol or drug addiction,
* having a score of 3 or 4 according to the modified Ashworth Scale
Comparison of PET/CT vs. PET/MRI Using 2 Radiopharmaceuticals

This clinical trial studies how well positron emission tomography (PET)/computed tomography (CT) works compared to PET/magnetic resonance imaging (MRI) in evaluating patients with cancer. PET/CT and PET/MRI may determine which scanner is best for the patient's type of cancer and other types of cancers.

PRIMARY OBJECTIVES:

I. To evaluate if PET/CT and PET/MRI scanners provide equivalent results for evaluation of cancer patients.

OUTLINE:

Patients receive standard of care 18F-fludeoxyglucose (FDG) or Ga68-DOTA-TATE intravenously (IV). Within 45-60 minutes, patients then undergo PET/CT imaging immediately followed by PET/MRI. Each participant is to receive 18-FDG or 68Ga-DOTA-TATE only, no participant was to receive both radiotracers.

Eligibility Criteria:
INCLUSION CRITERIA

* Cancer diagnosis
* Capable of complying with study procedures
* Able to remain still for duration of imaging procedure (approximately 90 minutes total)
* Written informed consent

EXCLUSION CRITERIA

* Pregnant or nursing
* Metallic implants
* Impaired renal function