cyrilzakka/clinical-trials huggingface dataset:
Bariatric Surgery and Pharmacokinetics of Quetiapine

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on quetiapine are investigated.


Eligibility Criteria:
Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract
Crisis Resource Management Improvement Through Intellectual Questioning of Authority

This is a randomized controlled trial examining the effectiveness of a teaching intervention on residents' and medical students' ability to challenge clearly wrong decisions by a superior during a simulated life-threatening crisis. Participants will be randomly allocated into the control or intervention arm. The intervention arm will receive education on crisis resource management (CRM) and teaching targeting the cognitive skills required to monitor and challenge a superior's decision, and conflict resolution tools. Participants will then take part in a simulation scenario 2 to 4 weeks later and will be assessed based on 6 challenge points, followed by a debrief session.


Eligibility Criteria:
Inclusion Criteria:

* Medical officers or Internal medicine, surgical and emergency medicine residents who are in their 2nd post-graduate year of training, or
* Phase V medical students from Yong Loo Lin School of Medicine, National University of Singapore

Exclusion Criteria:

* Refusal for informed consent, or
* Refusal for video recording during simulation sessions
Circulating Tumor DNA (ctDNA)-Guided Late-Line Treatment in Patients With Late-Stage Breast Cancer

This is a retrospective, observational, multi-center clinical study of circulating tumor DNA (ctDNA) to guide late-line therapy in late-stage metastatic breast cancer patients.

This study aims to evaluate the feasibility of plasma ctDNA mutation in guiding late-line treatment for late-stage metastatic breast cancer patients. Meanwhile, this study tries to evaluate the curative effect of ctDNA subtype-guided late-line therapy.

Eligibility Criteria:
Inclusion Criteria:

* Recent progression of TNBC after multiple lines of chemotherapy or of HR+ or HER2+ MBC after multiple lines of endocrine or targeted therapy;
* No available recommendation for the next treatment regimen;
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
* An updated, available pathological HR/HER2 status for metastasis;
* According to RECIST 1.1 standard, there should be at least one measurable target lesion;
* The expected survival time is \> 3 months;
* Those aged 18-70 years old;
* Liver and kidney function and blood routine test meet the following conditions: Neutrophil \> 2.0g/l, Hb \> 9g / L, PLT \> 100g / L; ALT and AST \< 2.5ULN; TBIL \< 1.5ULN; Cr \< 1.0ULN
* Signing informed consent;
* Those willing to accept polygenic testing.

Exclusion Criteria:

* Patients with multiple primary tumors;
* Those who are unable to obtain blood samples;
* Those with a history of immunodeficiency or organ transplantation;
* Those with abnormal cardiac function or previous history of myocardial infarction or serious arrhythmia;
* The researchers think it is not suitable to participate in this experiment.
Apogee International

Medtronic is sponsoring the Apogee International registry to further confirm safety and efficacy of the HVAD™ System when used as intended, in "real world" clinical practice and to enhance scientific understanding of the implant procedure, optimized blood pressure management, anticoagulation/ antiplatelet therapies, logfile analysis and acoustic spectrum analysis in patients receiving a Medtronic HeartWare™ HVAD™ for bridge to transplant and destination therapy indications.

Apogee International is a prospective, non-interventional, post-market, multi-site registry, conducted within Medtronic's Product Surveillance Registry (PSR) Platform. Enrollment into Apogee International will be comprised of newly implanted, commercial use patients with the HeartWare Ventricular Assist Device System (HVAD System).

Sites selected to participate are expected to collect data in at least one of these five modules:

1. Logfile Download;
2. Anti-coagulation / Anti-platelet Management;
3. Blood Pressure (BP) Management;
4. Acoustic Spectrum Analysis;
5. Infection Control

Eligibility Criteria:
Inclusion Criteria:

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements;
* Enrollment into Apogee International will be comprised of newly enrolled, commercial use patients with the HeartWare HVAD System;
* Patient is consented prior to the HVAD implant procedure.

Exclusion Criteria:

* Patient who is, or is expected to be inaccessible for follow-up;
* Participation is excluded by local law;
* Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the PSR results.
Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to External Auditory Apparatus

This is a non-randomized, multicenter, prospective, clinical study intended to evaluate the effectiveness of a method for iontophoretic delivery of a buffered lidocaine/epinephrine solution for provision of tympanic membrane anesthesia in patients who are indicated for an ear procedure requiring penetration of the tympanic membrane, including, but not limited to, myringotomy, tympanocentesis with culture or tympanostomy with tube placement.


Eligibility Criteria:
Inclusion Criteria:

1. Age 12 months and older
2. Both male and female patients eligible
3. Patients are indicated for procedures requiring penetration of the tympanic membrane (including, but not limited to, myringotomy, tympanocentesis with culture or tympanostomy with tube implant)

Exclusion Criteria:

1. Patients with a history of sensitivity or reaction to lidocaine, epinephrine or any hypersensitivity to local anesthetics of the amide type or any component of the drug solution
2. Markedly atrophic, retracted, atelectatic or perforated tympanic membrane
3. Otitis externa
4. Electrically sensitive patients and patients with electrically sensitive support systems (pacemakers, defibrillators, etc.)
5. Damaged or denuded skin in the auditory canal
6. Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
Clinical Evaluation of Bonded Versus Banded Space Maintainers

Comparing bonded space maintainers to banded space maintainers

Comparing bonded space maintainers to banded ones regarding clinical success in maintaining the space for the prematurely lost primary molar and radiographic space loss in both banded and bonded space maintainers. Finally, patient satisfaction regarding both treatments.

Eligibility Criteria:
Inclusion criteria:

Patient and parent showing cooperation and compliance. Medically free children. Patients having mandibular first deciduous molar indicated for extraction due to extensive coronal caries beyond possible repair, root caries and/or failed pulp therapy.

Having all first permanent molars erupted and in Class I molar relation. According to space analysis available space is less than or equal to needed space.

Having all their mandibular incisors erupted. With deciduous canines and second deciduous molars in the side of the extraction maintained throughout the entire follow-up period. Caries free, non-restored buccal surfaces of the mandibular second primary molars and deciduous canines. 1/3 to less than 2/3 of the root of the permanent successor is formed to the prematurely lost primary molars.

Exclusion criteria:

Children with any parafunctional habits. Children with previous allergies to stainless steel. Crowned abutment teeth. Permanent successors with 2/3 of its roots formed and space analysis does not indicate the fabrication of space maintainer.
Influence of a Prematuration Culture With a Phosphodiesterase-3 Inhibitor (PDE3-I) on Embryonic Aneuploidy Rate and Developmental Potential

A single centre randomised controlled trial investigating the influence of a novel prematuration system (PMS) using a phosphodiesterase-3 inhibitor for in-vitro maturation of oocytes


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers, either with PCOS/PCOS-like ovaries, or with normal ovaries, who undergo oocyte donation for research
* AFC at least 10
* AMH: \> 5 μg/L
* Female age \< 36 years

Exclusion Criteria:

* major uterine or ovarian abnormalities
Post Market Clinical Follow-Up Study for MicroPort PROFEMUR® Preserve Classic Femoral Stem

Sponsor is conducting this post market clinical study to evaluate the safety and effectiveness of its PROFEMUR® Preserve Classic Femoral Stem. This type of study is required by regulatory authorities for all devices that have been approved in Europe (EU) to evaluate the medium and long-term clinical evidence. This study has been designed in accordance with MEDDEV2.12/2 (European Medical Device Vigilance System) rev2 and ISO (International Organization of Standardization) 14155:2011 guidelines.


Eligibility Criteria:
Inclusion Criteria:

1. Has previously undergone or currently has been determined to undergo a primary THA with the study component MPO PROFEMUR® Preserve Classic Stem combined with any type of polyethylene or ceramic acetabular shells, acetabular liners and femoral heads.
2. Has previously undergone or currently has been determined to undergo a primary THA for any of the following:

   * non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
   * inflammatory degenerative joint disease such as rheumatoid arthritis;
   * correction of functional deformity
3. Willing and able to complete required study visits and assessments through the 10 year postoperative follow-up visit.
4. Previously implanted subjects must be enrolled within 3 years (+ 6 months) of their primary THA implantation.

Exclusion Criteria:

1. Skeletally immature (less than 21 years of age) at time of implantation
2. Has or had an overt infection at the time of implantation
3. Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
4. Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation
5. Has or had inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable
6. Has or had neuropathic joints
7. Has or had hepatitis or HIV infection
8. Has or had a neurological or musculoskeletal disease that may adversely affect gait or weight-bearing
9. Has or had a revision procedure(s) where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques
10. Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
11. Has or had documented substance abuse issues
12. Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
13. Currently incarcerated or has impending incarceration
14. Has a medical condition, as judged by the Investigator, that would interfere with the subject's ability to comply with the requirements of the protocol
Quality of Life and Life Satisfaction in Pediatric and Adolescent Gymnasts Through Injury

This study aims to assess the quality and life and life satisfaction of pediatric and adolescent gymnasts throughout their musculoskeletal injury recovery.


Eligibility Criteria:
Inclusion Criteria:

* Male and female gymnasts ages 8-18 years old
* Participating in Excel or Developmental gymnastics programs who present to Children's Hospital Colorado sports medicine or orthopedic clinics with a musculoskeletal injury.

Exclusion Criteria:

* Gymnasts only participating in Colorado Association for Recreational Athletics (CARA) gymnastics, retired gymnasts, and adult or collegiate gymnasts.
* Vulnerable populations (prisoners, pregnant women, individuals with decreased decision making capacity(
New Tablet Containing Two FDA Approved Anti-HIV Drugs For Antiretroviral Therapy Experienced HIV-1 Infected Subjects

A 48-week study to investigate the safety and effectiveness of a new compact formulation of two already FDA-approved anti-HIV drugs in subjects who have already been receiving treatment for their HIV infection.

A phase III, randomized, open-label, parallel, multicenter study to evaluate treatment with fixed-dose combination of abacavir/lamivudine (600mg/300mg) once-daily versus abacavir (300mg) twice-daily and lamivudine (300mg) once-daily in combination with tenofovir once-daily and a new PI or NNRTI for 48 weeks in ART-experienced HIV-1 infected patients.

Eligibility Criteria:
Inclusion Criteria:

* Antiretroviral therapy (ART) experienced and currently receiving a stable regimen containing 3 nucleoside reverse transcriptase inhibitors (NRTIs), or 2 NRTIs plus a protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) for at least 3 months (there should be no significant ART modifications for at least 3 months and no ART change anticipated between Screening and initiation of the study therapy).
* Patients must be naive to tenofovir.
* HIV-1 RNA level \> 1000 copies/ml on at least one occasion within 21 days of study entry.
* A CD4 cell count \> 50 cells/mm3.
* Specified viral genotypes.

Exclusion Criteria:

* Pregnant or breast-feeding women.
* Has an active diagnosis of AIDS.
* Additional qualifying criteria to be determined by the physician.
Clinical Study on Zirconia Bridges

To evaluate the clinical performance and survival rate of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region for a period of 5 years. The working hypothesis of this clinical study is that industrial centrally produced 3- or 4-unit bridges of shaded yttrium-oxide partially-stabilized (Y-TZP) zirconia (NobelProceraTM Shaded Zirconia) in combination with a veneering ceramic material will show sufficient CDA ratings (80% R+S) and a sufficient survival rate (93%) after 5 years in comparison with a reference level of 95%.


Eligibility Criteria:
Inclusion Criteria:

The subject must be at least 18 (or age of consent), and less than 70 at the time of inclusion.

* The subject is healthy and compliant with good oral hygiene
* The subject is in need of a posterior fixed partial denture restoration of up to 4 units distal of the canines in the maxilla or mandible.
* The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.
* Obtained informed consent from the subject the subject should be available for the 5-year term of the investigation.
* No apical disorder or inflammation of abutment teeth, adjacent and opposing teeth.
* Good gingival / periodontal / periapical status of restoring, opposing and adjacent teeth. Healed situation of soft tissue augmentation is allowed.
* The subject should be available for the 5-year term of the investigation.

Exclusion Criteria:

* The subject is not able to give her/his informed consent to participate.
* Alcohol or drug abuse as noted in patient records or in patient history.
* Reason to believe that the treatment might have a negative effect on the patient's total situation (psychiatric problems), as noted in patient records or in patient history.
* An existing condition where acceptable retention of the restoration is impossible to attain
* Mobility of the tooth to be restored.
* Pathologic pocket formation of 4 mm or greater around the tooth to be restored
* Severe bruxism or other destructive habits
* Amount of attached soft tissue is insufficient (no attached gingiva on the buccal side of the tooth).
* Health conditions, which do not permit the restorative procedure
Treatment for Chronic Spinal Cord Injury: Surgery With Rehabilitation vs Rehabilitation

The purpose of this study is to investigate the efficacy of surgical decompression/untethering, combined with weight bearing rehabilitation, on neurological recovery following chronic spinal cord injury.

Safety Issues:

Safety issues need to be watched are: occurrence of known and unknown undesirable incidences, moving up injury levels, loss of previously preserved neurological functions, vital physical signs, and worsening of EKG and lab results. If unforeseen issues occur, patients will be consulted to determine whether treatments will be continued.

Adverse events:

Adverse events may occur during the trail and these events will be recorded. The severity of the events and their relationship to the experimental therapy will be determined, documented and reported to the Data Monitoring and Safety Committee who will determine how these events will be handled if they occur.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adult subjects, 18-60 years of age
* Have a clinical diagnosis of chronic spinal cord injury (≥ 12 months after traumatic spinal cord injury).
* Neurological examination: ASIA-A
* Injury levels: T1-T12 spinal levels
* The diagnosis of spinal cord injury is confirmed by MRI
* Subjects must be able to read, write and complete visual analogue scale
* Voluntarily signs and dates an informed Consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific procedures. If a subject consents to participation but is not in a position to personally sign and date the informed consent form because of his or her physical condition, the consent must be confirmed at the time of consent orally, signed on behalf by the subject's relative, and by an impartial witness who is present throughout the whole informed consent process.

Exclusion Criteria:

* Severe head injury
* Subjects with severe osteoporosis or joint diseases
* Subjects with severe pressure sore
* Sign of kidney, cardiovascular, liver disorders
* Subjects with internal medical and/or infectious diseases (including but not limited to Hepatitis B and HIV carriers)
* Pregnant women or women at lactation stages
* Medically or mentally unstable according to the judgment of the investigator
* History of multiple sclerosis or peripheral demyelination
* Any criteria which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol
Reference Values for Gastric Emptying

Healthy volunteers will ingest a 13C-octaoate containing test meal and 13C in expiratory air will be followed. Normal values will be calculated data of these tests.

This is a clinical study for establishing reference values in a 13C-octanoate breath test and a 13C-sodium acetate breath test. Healthy volunteers (n=75) will eat a solid test meal of scrambled eggs and toast containing 13C-octanoate. 13C-content of exhaled air will be measured at baseline and followed for the next 4 hours. One week later, the healthy volunteers (n=75) will drink a standardized nutritional shake (Ensure Plus Vanille, Abbott) containing 13C-sodium acetate. 13C-content of exhaled air will be measured at baseline and for the next 4 hours. Estimated gastric emptying time will be calculated using established algorithms.

Eligibility Criteria:
Inclusion Criteria:

* Subjects free of relevant abdominal complaints
* Written informed consent

Exclusion Criteria:

* Age under 18
* Previous history of gastrointestinal disease or surgery (excludes appendectomy, hernia repair and anorectal disorders)
* Known diabetes mellitus, scleroderma, neurological impairment or other major current disease
* Subjects unable to stop medication that alters gut function for 1 week prior to the study, including anticholinergics, calcium canal inhibitors, beta blocker, prokinetics, proton-pump inhibitors, DDV-IV-Inhibitors, Inkretin-mimetica, non-steroidal anti-inflammatory drugs, macrolid antibiotics
* Pregnancy beyond week 12 (no pregnancy test will be performed)
* Involvement in any other clinical trial during the course of this trial, nor within a period of 14 days prior to its beginning or 14 days after its completion
* Known allergy or intolerance against hen egg protein or gluten
Pattern and Short Term Outcomes of Renal Affection in Patients With Liver Cirrhosis in Al-Rajhi Liver Hospital

* To characterize the pattern and the prevalence of renal affection among liver cirrhosis patients.
* To evaluate the short-term outcomes of those patients.

Liver cirrhosis is a chronic liver disease characterized by significant scarring and dysfunction. One of its common complications is renal affection , which can significantly impact patient outcomes .

Aetiology of AKI can be categorized into three main types. These are prerenal (results from decreased renal perfusion), intrinsic renal (acute tubular necrosis), and postrenal AKI. In patients on admission, acute tubular necrosis is a common type of intrinsic AKI .

The development of portal hypertension in patients with liver cirrhosis leading to a reduction in systemic vascular resistance as a result of primary arterial vasodilation in the splanchnic circulation is the primary cause of AKI in cirrhotics. This mechanism primarily leads to hepatorenal syndrome. In addition, the underlying causes of liver cirrhosis can be the cause of intrinsic renal disease .

Early identification and management of AKI may improve outcomes. AKI in patients with liver cirrhosis in Egypt and their impact on inpatient mortality are largely unknown. This study was aimed at determining the prevalence, precipitating factors, predictors, and in-hospital mortality of AKI in patients with liver cirrhosis admitted at Al-Rajhi liver hospital at Egypt .

Eligibility Criteria:
Inclusion Criteria:

* Patients with liver cirrhosis admitted to the department .

Exclusion Criteria:

1. Patients with known preexisting chronic kidney disease according to KDIGO and EASL 2018 definitions ( defined as functional GFR \<60 ml/min per 1.73 m 2 for ≥3 months or structural kidney damage for ≥3 months ).
2. Patient refusal to give informed consent ( or his first degree relatives in case of disturbed conscious level).
Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts

This is a prospective, non-randomized data collection study to evaluate the performance of the Masimo INVSENSOR00063 in obtaining temperature measurements.

Individual sites are only representative of a subset of the overall population, per ISO 80601-2-56:2017(Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement), and therefore clinical bias and limits of agreement should not be evaluated for the subsets. Publication of results should include repeatability from individual sites and the combined clinical bias and limits of agreement (NCT05787782, NCT05674344 and NCT05779397).

Eligibility Criteria:
Inclusion Criteria:

* Participant age ≥ 1 year
* Afebrile or febrile at time of enrollment: For febrile subjects, ≥ 99.5 F/ 37.5 C for sublingual temperature reference; ≥ 100.4 F/ 38 C for temporal artery temperature reference.
* English-or Spanish-speaking patient or parent/Legal Guardian

Exclusion Criteria:

* Participants deemed not suitable for the study at the discretion of the investigator