cyrilzakka/clinical-trials huggingface dataset:
Effects of 60-day-6° Head-down Bed Rest on Cartilage and Function of the Knee Joint

Objective: To investigate the effects of long-term simulated unloading in bed on articular cartilage quality based on functional magnetic resonance imaging (FMRI) and Knee joint function.

A total of 26 subjects were recruited for a 60-day period of head-down bed rest (HDBR). The bed rest position is a 6° downward tilt of the head, and all daily activities are performed in this position. We will perform functional MRI scans of the right knee joint using T2 mapping sequences to assess tissue composition and water content before and after HDBR. Functional assessments, including the Y-Balance Test and International Knee Documentation Committee (IKDC) scores, were performed pre-HDBR and post-HDBR.We will divide each participant's knee cartilage into 18 regions and measured T2 values according to the whole organ magnetic resonance imaging score (WORMS) partitioning method.

Eligibility Criteria:
Inclusion Criteria:

* (1) male; (2) age 25-50 years old; (3) height between 160-175 cm, weight ≥50kg, and BMI between 18.5-26 kg/m²; (4) good general health status.

Exclusion Criteria:

* (1) history of alcoholism; (2) smoking ≥5 cigarettes/day in the 3 months before the test; (3) drug dependence or use of medications affecting bone metabolism within 2 weeks before screening; (4) presence of metal implants, severe vertigo, or severe snoring.
NoPro - Norwegian Hernia Prophylaxis Study

A multicenter randomized controlled trial comparing midline laparotomy closures using the small-bite suture technique alone to those using the small-bite suture technique with an additional onlay prophylactic polypropylene mesh. The primary endpoint is the incidence of incisional hernias in both groups after one year.

An incisional hernia (IH) is a defect in the abdominal wall at the site of a surgical scar, leading to the protrusion of abdominal contents through the defect. It is a common complication following midline laparotomy, with incidence rates ranging from 9% to 40% in the general population, and up to 69% in high-risk patients. Several studies have been conducted on the prevention of IH, and one established intervention is the use of a synthetic mesh to reinforce the suture closure of the abdomen after midline laparotomy. However, the use of mesh in this context is not widespread in Norway, and there are no Norwegian studies on IH prevention following midline laparotomy. This study aims to contribute to the broader knowledge base and encourage Norwegian surgeons to consider using prophylactic meshes.

The study will involve three Norwegian hospitals: Hamar Hospital, Gjøvik Hospital, and Lillehammer Hospital. Participants will be patients scheduled for midline laparotomy at these hospitals who consent to participate, meet the inclusion criteria, and do not meet any exclusion criteria. Participants will be randomly assigned to two groups, each receiving a different variation of fascia closure during laparotomy. One group will undergo closure using the standard small-bites technique only, while the other group will undergo closure with the small-bites technique in addition to an onlay polypropylene mesh.

The primary outcome is the occurrence of incisional hernia one year after surgery, identified through clinical examination and CT scan. Additionally, surgical site occurrences (e.g., hematoma, infection, seroma, wound dehiscence) will be recorded four to six weeks post-surgery. Quality of life and pain levels will also be assessed at both four to six weeks and one year after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Surgery predominantly done my midline laparotomy
* Age 18 years old or older
* Written consent by patient/family
* Midline laparotomy with delayed closure
* No exclusion criteria

Exclusion Criteria:

* Age under 18 years
* Pregnancy
* Previous abdominal midline hernia mesh repair
* Abdominal compartment syndrome
* Linea alba closure not possible
* Life expectancy under six months
* Hernia in the midline with transverse diameter lager than 2 cm
Control of Assistive Devices Via Brain-Computer Interface Technology

The CONVOY Study is a clinical trial designed to explore the feasibility of participants from the PRIME Study (NCT06429735) using the N1 Implant to control various assistive devices. The main goal is to determine whether participants can successfully modulate their brain activity to control devices, such as an Assistive Robotic Arm (ARA). This study will assess the effectiveness, consistency, and safety of neural control using the ARA and other assistive devices.


Eligibility Criteria:
Inclusion Criteria:

* Continued enrollment in the PRIME Study.
* Implanted with the N1 Implant.

Exclusion Criteria:

* Explantation or deactivation of the N1 Implant.
* Insufficient N1 Implant BCI performance demonstrated.
* Explantation or deactivation of the N1 Implant.
* Lack of a suitable physical space to perform research sessions.
* Any condition which, in the opinion of the Investigator, would compromise the candidate's ability to safely participate in the study.
Impact of Reduction of Dust Mite Allergenic Load on Step Down of Inhaled Corticosteroids in Stable Asthma

Eviction methods for dust mite allergy have been evaluated in asthma control in a recent Cochrane meta-analysis. None have shown efficacy on asthma control and there are not recommended. The purpose is to evaluate the efficacy of a new commercialized system (Acar'Up) to decrease dust mite load and to assess its impact on the possibility to perform inhaled corticosteroids step down in stable asthmatics.

Eviction methods for dust mite allergy have been evaluated in asthma control in a recent Cochrane meta-analysis. None have shown efficacy on asthma control and there are not recommended. The purpose is to evaluate the efficacy of a new commercialized system, Acar'Up (a spray pulverized on a technical textile that traps the dust mite) to decrease dust mite load and to assess its impact on the possibility to perform inhaled corticosteroids step down in stable asthmatics.

Eligibility Criteria:
Inclusion Criteria:

* confirmed asthma diagnosis
* controlled asthma for more than 3 months
* treatment with inhaled corticosteroids
* dust mite allergy proved by skin tests ou specific immunoglobulin E

Exclusion Criteria:

* chronic obstructive pulmonary disease, bronchiectasis, Fibrosis, tuberculosis
* asthma-chronic obstructive pulmonary disease overlap syndrome
* ongoing desensitization for dust mite
* pregnancy
* previous use of Acar'up
Appetite Profile After Intake of Rye Breakfast Meal

Food structure influence metabolic response including appetite. Whole grain foods include a wide range of products; cracked or cut kernels, rolled flakes or milled to flour and used in foods such as breads, breakfast cereals and pasta.

The aim of the present study was to investigate if rye grain structure influence perceived appetite. A comparison of whole rye kernels and milled rye kernels were done in two study parts. In the first part the rye was served as porridge breakfasts and in the second one milled and whole kernels were included into bread breakfasts. In order to observe potential effects that would arise when the remains of the meal reaches the colon, the period of measurement was set to 8 h after intake of iso-caloric rye bread and rye porridge breakfasts.

A randomized, crossover design was used to compare the effects of iso-caloric breakfast meals on subjective appetite during 8 h after consumption.

Eligibility Criteria:
Inclusion Criteria:

* 20 and 60 years;
* body mass index (BMI) 18-27 kg/m2;
* habit of consuming breakfast, lunch and dinner every day
* willingness to comply with the study procedures

Exclusion Criteria:

* intake of medicine likely to affect appetite or food intake;
* any medical condition involving the gastrointestinal tract;
* eating disorder;
* smoking;
* consumption of more than three cups of coffee per day;
* change of body weight more than 10% three months prior to screening;
* consumption of any restricted diet such as vegan, gluten free, slimming etc.;
* pregnancy, lactation or wish to become pregnant during the study period
BIIB014 Cardiovascular Monitoring Study

The study will examine the effects of a single dose of BIIB014 on blood pressure and haemodynamic variables in healthy volunteers over 24 hours.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects
* Between the ages of 18 and 50, inclusive.
* Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive

Exclusion Criteria:

* Clinically significant abnormalities (as determined by the Investigator)
* Other unspecified reason that would make the subject unsuitable for enrollment (as determined by the Investigator)
Radiation Medicine Patient Registry, Loma Linda University Medical Center

For most cancers, long-term follow-up is the best measure of treatment effectiveness. The Department of Radiation Medicine at Loma Linda University Medical Center operates the James M. Slater, M.D., Proton Treatment and Research Center, the world's first hospital-based proton treatment facility. Patients have been treated at the Center since 1990. Radiation treatment has been expanded and refined since the Center's opening, and these changes have been based primarily on outcomes seen and evaluated in long-term follow-up.

The Radiation Medicine Patient Registry (a multi-year database), which began as an IRB-approved study in 2003, including detailed follow-up of study data collected from 1990 and onward, is designed to track all medical information from patients treated with proton therapy and/or conventional X-ray therapy at Loma Linda University Medical Center. Information gathered from patients treated years or even decades ago helps to determine the most effective use of proton and conventional radiation in caring for patients with cancers and other diseases.

The patient registry will be posted to accomplish three objectives:

1. Perform retrospective research studies on diseases treated with proton therapy and conventional photon radiation.
2. Maintain regular and life-long contact with patients in order to obtain current identification, contact information, and self/parent-reported health status. This information is used to generate better understanding of treatment strategies and, in turn, increase benefits to patients.
3. Enable physicians to review of medical record information and so to identify subjects who may be eligible to participate in future research studies. This requires obtaining permission from registered participants that they may be contacted and asked if they are interested in participating in studies for which they may be eligible, as determined by their medical information contained in the registry.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of benign or malignant tumors or other conditions deemed treatable by proton or conventional photon radiotherapy
* Willingness to sign an Informed Consent Document

Exclusion Criteria:

* There are no specific exclusion criteria, but patients who are unwilling to sign the ICD will not be included
EVPOME Versus AlloDerm in Subjects Reconstructed With Large Defect Mandibular Resection

The purpose of this study is to compare the safety and effectiveness of performing oral reconstructive surgeries using either AlloDerm, a product commonly used for this purpose, or AlloDerm that has been overlaid with the subject's oral mucosal cells and developed into a type of graft that is called an ex vivo produced oral mucosal equivalent, EVPOME.


Eligibility Criteria:
Inclusion Criteria:

* Be an adult over 18 years of age
* Have a free fibular graft placed more than six months ago that has been used for restoration of mandibular continuity.
* Be in need of surgery to increase the vestibular fold of the grafted mandible for placement of a dental prosthesis to restore function

Exclusion Criteria:

* Any liver, kidney, heart, blood, metabolic or systemic disease which may make execution of the protocol of interpretation of the results difficult
* A history of syphilis, HIV, Hepatitis B or Hepatitis C
* Pregnancy or planning to become pregnant
* Known or suspected allergy to bovine (cow) protein
* Receiving radiation
* Currently smoking or using tobacco products
* Talking medication that can result in gingival enlargement (Cyclosporine, Dilantin, calcium channel blockers)
* Allergy to any of the following antibiotics Gentamycin, Cefoxitin, Lincomycin, Polymyxin B, Vancomycin, cephalosporins, or clindamycin
* Allergy to Polysorbate 20
Study to Evaluate the Effect of Aficamten Administration on QT/QTc Interval

This is a single-center, 2-part (Part A and Part B) study in healthy participants. Part A (Dose Finding) is an open-label, SAD study to identify the dose for Part B. Part B (TQT Study) is a randomized, double-blind (with respect to aficamten and matching placebo), positive- and placebo-controlled, single-dose, 3-way crossover study to evaluate the effect of aficamten administration on QT/QTc interval.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, adult, male or female, 18-45 years of age, inclusive, at the screening visit.
* Continuous non-smoker who has not used nicotine- and tobacco -containing products for at least 3 months prior to the first dosing based on participant self- reporting.
* Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 at the screening visit.
* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, and vital signs, as deemed by the PI or designee, including the following:

  * Supine blood pressure is ≥ 90/40 mmHg and ≤ 140/90 mmHg at the screening visit.
  * Oxygen saturation (SpO2) is ≥ 95% at the screening visit.
  * Liver function tests (e.g., bilirubin, aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\]) considered not clinically significant in the opinion of the PI or designee at the screening visit.
  * Estimated creatinine clearance ≥ 90 mL/min at the screening visit.
* No clinically significant history and presence of ECG findings as judged by the PI or designee at the screening visit and first check-in, including each of the following:

  * HR between 50 bpm and 100 bpm, inclusive.
  * QTcF interval is ≤450 msec (males) and ≤460 msec (females).
  * QRS ≤110 msec; if \>110 msec, result will be confirmed by a manual over read.
  * PR ≤220 msec.
* LVEF ≥65% at the screening visit.

Exclusion Criteria:

* History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
* History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
CLN-0046: Treatment of AMD Subjects With OTX-TKI

To evaluate the safety, tolerability and efficacy of OTX-TKI for intravitreal use, in subjects who have neovascular age-related macular degeneration (AMD).

A multi-center, dose escalation, Phase 1, safety, tolerability and efficacy study to evaluate three dose groups of the OTX-TKI implant to treat subjects with a diagnosis of primary subfoveal neovascularization secondary to AMD.

Eligibility Criteria:
Inclusion Criteria:

* Are at least 50 years of age
* Are eligible for standard therapy
* Have active primary CNVM secondary to AMD, either newly diagnosed or previously treated with documented response to anti-VEGF therapy in the study eye \[primary subfoveal CNV secondary to AMD including juxtafoveal lesions that affect the fovea\] documented by FA and SD-OCT
* Are female who is postmenopausal for at least 12 months prior to screening or surgically sterile; or male or female of childbearing potential willing to use two forms of adequate contraception
* Are able and willing to comply with all study requirements and visits

Exclusion Criteria:

* Have previous laser photocoagulation to the center of the fovea in the study eye
* Have participated in any study involving an investigational drug either in the U.S. or outside the U.S. within the past 30 days
* Are an employee of the site that is directly involved in the management, administration, or support of the study, or be an immediate family member of the same
* Have a presence of a disease other than CNVM due to AMD in the study eye that could affect vision or safety assessments
Computerized Cognition Testing in Participants With Mild Alzheimer's Disease (AD) Treated With Donepezil (MK-0000-318)

This study aims to determine whether the Cogstate testing battery can detect improvements in cognitive function in participants with mild AD. The primary hypothesis is that for one of the Cogstate battery tests, One Card Learning (OCL), the standard deviation associated with the change from baseline in OCL measurements after 12 weeks of donepezil and placebo treatments is =\<0.1


Eligibility Criteria:
Inclusion Criteria:

* Meets listed criteria for a diagnosis of probable AD
* Has a clearly documented history either in medical records or from an informant of cognitive decline over at least 6 months
* Has a reliable partner/caregiver who is willing to provide input by participating in assessments
* Has results of a physical examination and clinical laboratory tests within normal or clinically acceptable limits
* Can communicate with trial staff acceptably, possesses the ability to respond verbally to questions, follow instructions, complete questionnaires, and adhere to visit schedules
* Can read at a 9th grade level or equivalent, and has an acceptable history of academic achievement and/or employment
* Has a magnetic resonance imaging (MRI) scan that rules out non-AD conditions contributing to cognitive dysfunction
* Capably performs the CogState screening battery
* Has adequate visual acuity and function
* Females are not of childbearing potential

Exclusion Criteria:

* Has ever received acetylcholinesterase inhibitors, memantine, or other symptomatic AD treatment including approved medical foods
* Has an uncontrolled, clinically significant medical condition or situation within 3 months prior to screening
* Has had major surgery within 3 months prior to screening
* Has tested positive for human immunodeficiency virus (HIV) or has evidence of an active hepatitis B infection
* Has a history of malignancy within the prior 5 years
* Is unwilling or ineligible to undergo an MRI scan
* Has a history of clinically important structural changes on screening MRI scan
* Has a clinically important history of stroke or a diagnosis of vascular dementia
* Has evidence of a clinically relevant non-AD neurological disorder
* Has a history of head trauma, or serious infectious disease affecting the brain within the prior 3-5 years
* Has evidence of a clinically relevant or unstable psychiatric disorder, excepting major depression in remission
* Has evidence of a current episode of major depression
* Has evidence of Type 4 or Type 5 Suicidal Ideation
* Has clinically significant vitamin B12 or folate deficiency in the 6 months prior to screening
* Is pregnant, attempting to become pregnant or is nursing children
* Has used any investigational drug or participated in any other clinical trial within the prior 30 days
* Has a history of alcoholism or drug dependency/abuse within the last 5 years
* Has a relative contraindication to donepezil including sick sinus syndrome, third degree heart block, active gastrointestinal (GI) bleeding, Zollinger-Ellison syndrome, uncontrolled peptic ulcer disease, or uncontrolled asthma
Treatment of Sacroiliac Dysfunction With SI-LOK® Sacroiliac Joint Fixation SI-SI-LOK

The objective of this study is to gather clinical data on SI-LOK® for the treatment of sacroiliac joint dysfunction.

The purpose of this prospective study is to evaluate clinical and radiographic outcomes, intra-operative parameters, patient satisfaction and work status following a procedure using SI-LOK® for treatment of sacroiliac joint dysfunction with a minimum of three screws.

Clinical Research Forms will be completed at all pre-op, intra-op and post-op visits by either the surgeon, clinical coordinator or patient.

Forms completed by patients will be checked, initialed and dated by the site coordinator.

Data collected will be presented as mean +/- standard deviation. Statistical significance will be evaluated at the P \< 0.05 significance level.

Eligibility Criteria:
Inclusion Criteria:

* A maximum age of 70 years
* Diagnosis of SIJ dysfunction
* Ability to provide Informed Consent for study participation and to return for all follow-up visits

Exclusion Criteria:

* Previous documentation of osteopenia or osteomalacia
* History of metabolic bone disease (e.g. diabetes requiring daily insulin)
* Diagnosis of a condition or requires postoperative medication(s), which may interfere with bony/soft tissue healing
* Presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, HIV, long term use of steroids, etc.)
* History of substance abuse (drugs or alcohol)
* Condition that would preclude completing patient self assessment questionnaires
* Mentally incompetent or prisoner
* Currently a participant in another study
Repeatability of OCT and IV-US in Pulmonary Arterial Hypertension

To assess the correlation between pulmonary IV-OCT and pulmonary IV-US measurements and standard PAH clinical measures of disease progression and the relative sensitivity of the techniques to change.


Eligibility Criteria:
Inclusion Criteria:

* With confirmed diagnosis of PAH Group 1 according to the ESC/ERS Guidelines
* With severe disease, defined as Class II- III of the modified WHO functional classes in the ESC/ERS Guidelines

Exclusion Criteria:

* That according to investigator criteria cannot participate in the trial
Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis for Ocular Hypertension Control After Intravitreal Bevacizumab

The purpose of this study is to evaluate the effects of anterior chamber paracentesis, brimonidine and oral acetazolamide to reduce intra-ocular pressure variations after intravitreal bevacizumab injection.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of age related macular disease or diabetic retinopathy
* Able and willing to provide informed consent

Exclusion Criteria:

* History of ocular hypertension or glaucoma
* High Myopes (\> 6 spherical diopters)
* High Hyperopes (\> 4 spherical diopters)
* Pulmonary disease
* Renal disease
* Known allergy to any component of the study drug
* Myocardial infarction, transient ischemic attack within 4 months prior to randomization or any contraindication for bevacizumab use