cyrilzakka/clinical-trials huggingface dataset:
Using the Norm Range to Predict the Effect of Food Portion Size Reductions on Compensation Over 5 Days

Reducing food portion size is a potential strategy to reduce energy intake. However it is unclear at what point consumers compensate for reductions in portion size by increasing energy intake from other items. This could result in no overall benefit of reducing food portion sizes. The investigators tested the hypothesis that reductions to the portion size of components of a main meal will only result in significant compensatory eating when the reduced portion size is no longer visually perceived as 'normal'. In a crossover experiment, participants were served different sized portions during lunch and dinner over 5 days: a 'large-normal', a 'small-normal', and a 'smaller than normal' portion. Intake from all other meal components consumed in the laboratory were measured.


Eligibility Criteria:
Inclusion Criteria:

* willing to consume the test foods
* BMI between 22.5 - 32.5

Exclusion Criteria:

* food allergies, intolerances or specific dietary requirements (including being vegetarian or vegan)
* history of eating disorders
* taking medication which affected appetite
* participated in a portion size studies in the past 12 months, or in dieting or weight loss trials in the past 4 weeks
Social Cognition and Interaction Training for Improving Social Functioning in People With Schizophrenia

This study will determine the effectiveness of social cognition and interaction training, a manual-based group therapy program, in helping people with schizophrenia improve their social cognition and social functioning.

Schizophrenia is a serious mental condition that affects approximately 1.1% of adults in the United States. People with schizophrenia experience reality perception impairments, which most commonly manifest as hallucinations, extreme paranoia, social withdrawal, and disordered thinking. Deficits in social functioning are a core feature of schizophrenia. In an effort to improve social functioning, there has been growing interest in identifying factors that underlie psychosocial impairments. One such identified factor has been neurocognition, but treatments that target solely cognitive processes do not always help overall social functioning. Social cognition and interaction training (SCIT), a group-based treatment that aims to improve both processing social information and functioning, may be an effective treatment for enhancing the social skills of people with schizophrenia. This study will compare the effectiveness of SCIT versus treatment as usual (TAU) in helping people with schizophrenia improve their social cognition and social functioning.

Participation in this single-blind study will last 11 months. All potential participants will undergo initial screening, involving the completion of a few brief tasks testing social functioning. Eligible participants will then be randomly assigned to receive SCIT plus TAU or TAU alone. Participants assigned to receive SCIT will attend twenty 1-hour weekly group sessions over 5 months. During these sessions, participants will learn ways to manage emotions, work through problems, and integrate into social situations. Participants assigned to TAU alone will meet with their case managers and healthcare provider on an as-needed basis. All participants will undergo assessments of social cognition, social functioning, and psychotic symptoms prior to treatment, immediately post-treatment, and 6 months after treatment. Each assessment will last 3 hours and will include interviews, questionnaires, and a variety of tasks testing social skills. Researchers will also contact a family member or significant other about the participant's social functioning at the same three assessment times noted above.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for schizophrenia or schizoaffective disorder, based on the Structured Interview of DSM-IV patient version (SCID-P)

Exclusion Criteria:

* Meets current criteria for substance dependence, based on the SCID-P
* Meets criteria for metal retardation (e.g., has an IQ of less than 80)
* History of brain injuries
* Difficulties interacting with others, based on ratings on items from the Social Functioning Scale that tap interactional skills
MISOBOLD - Prostate Cancer Hypoxia Using BOLD MRI and 18F-MISO PET Imaging

This feasibility exploratory study objective is to assess the ability of combined MRI BOLD and 18F-MISO PET imaging to visualize tumor hypoxia compare to histological results obtained after radical prostatectomy in order to, in time, be able to identify patient with bad prognostic and to offer them the best therapeutic strategy.

Prostate cancer is the fisrt one in male with 80.000 new cases each year in France. Forty thousand curative treatments are performed each year, but 25 to 30% of these patients will present a cancer reccurence after radical surgery or conformationnal radiotherapy, Tissu hypoxia seems to be mainly responsible of the local reccurence and conduct to molecular damages that creates carcinogenesis and tumor agressitivity. This hypoxia inhibits the DNA healing and the apoptosis but increases the angiogenesis, that leads to treatment resistance. L. Marignol \&al clearly showed that hypoxia may have a main role in hormonal resistance. Furthermore, M. Milosevic \& al showed that hypoxia is an independent factor of local reccurence after radiotherapy. Nowadays, new technics of IMRT in radiotherapy planning could be able to target an hypoxic prostate region to prevent reccurence. Patients who are eligible to radical prostatectomy will benefit of a prostate MRI with BOLD sequences and a 18F-misonidazole PET before surgery. The results of these two technics will be compared to the histological results using CAIX and HIF immunohistochemistery markers

Eligibility Criteria:
Inclusion Criteria:

* Patient above 18.
* Prostate tumor with histological confirmed diagnosis and highly radiological suspected target on MRI
* High risk patient : \>T2c grade, Glasgow score \> 7 and PSA \> 20ng/ml
* Surgical treatment chosen during multidisciplinary meeting
* ECOG ≤2
* Patient must have undergone MRI with BOLD sequence less than 6 month prior surgery
* Member or beneficiary of a social security system.
* Signed informed consent.

Exclusion Criteria:

* Patient included in another clinical study
* Geographical, social or psychological reasons preventing patient from submitting to the study's medical monitoring
* Patient deprive of liberty, adult subjects to legal protection or unable to give consent
* Contraindications to MRI
* Contraindication to gadolinium injection
Influence of Insertion Torque and Bone Type on Post-operative Pain

The objectives of this clinical study were to assess the effect of different ITs and bone types on POP levels and survival rates and to investigate the effect of different patient- and site-related factors on POP levels and survival rates.

This prospective clinical study included 230 patients treated with a single tapered screw implant (Bioinnovation Dental®, Brazil). The implants were placed using the appropriate burs with a final master drill of 3.5 or 4.5 mm in diameter by one senior oral surgeon. These implants were multi-threaded, and their surfaces were both sandblasted and acid etched. Of the 230 participants, 172 received a single 5 x 10-mm implant, and 58 received a 4 x 10-mm implant.

For the higher torque range (90 - 200 Ncm), the maximum IT was recorded with an electronic digital torque measuring device (Tohnichi BTGE200CN-G, Hitachi, Japan), while a different gauge (Tohnichi BTG90CN-S, Hitachi, Japan) was used for the lower torque range (10 - 90 Ncm). All implants were placed at the crestal level and closed with a cover screw, and the flap was then sutured with non-resorbable 4/0 nylon suture (Resorba® Germany).

Pain levels were recorded at day 1, 2 and 4 and at week 1, 2 and 3 after surgery using visual analog scale (VAS) ranging from 0 "no pain" to 10 "worst pain ever. Implants were classified into 4 groups based on the IT value; Low: 60 implants (10-29 Ncm, mean=15 Ncm); Regular: 102 implants (30-50 Ncm, mean=42 Ncm); High: 47 implants (51-100 Ncm, mean=75 Ncm); and Very high: 21 implants (101-200 Ncm, mean=170 Ncm).

Implant survival was assessed clinically and radiographically at 3, 6, 12, 24 and 36 months. The criteria for implant success according to Buser et al, were no radiolucent zone around the implant, confirmed individual implant stability, and no suppuration, pain or ongoing pathologic processes. All implants that failed to fulfill these success criteria were regarded as failures.

The effect of IT, bone type, implant location, age, gender and smoking was measured with regression analysis. Kaplan-Meier survival analysis was performed to calculate the overall implant survival probabilities. The level of statistical significance was set at p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* partially edentulous patients who presented with one or more missing teeth in the maxillary or mandibular jaw
* at least18 years old, adequate oral hygiene
* absence of infection or periodontal problems adjacent to the implant site - sufficient bone thickness with a minimum 6-mm width and 12-mm length to accommodate implants of 4 or 5 mm in diameter and 10 mm in length.

Exclusion Criteria:

* uncontrolled diabetes
* hypertension
* pregnancy
* bone diseases
* use of bisphosphonates
* heavy smoker (more than 20 cigarettes /day)
* severe alcohol or drug use
* patients with recent extraction of teeth and patients requiring bone and soft tissue augmentation procedures.
The Effect of Home Accidents Prevention Training Given to Mothers of Mentally Disabled Children

The aim of this research is to examine the effect of education for home accidents given to mothers with mentally disabled children in the age group of 0-6.

This study was conducted to examine the effects of education on home accidents given to mothers of mentally disabled children aged 0-6. The sample of the study consisted of 83 mothers of mentally disabled children aged 0-6 registered in four special education centers in Kocaeli province between May 2023 and June 2024 (education group: 40 mothers; control group: 43 mothers). Research data were collected using the Information Form and the Scale for Diagnosing Mothers' Safety Precautions for Home Accidents in 0-6 Year Old Children. The mothers in the education and control groups were informed about the study, their written consent was obtained, and they were asked to fill out information forms. The mothers in the education group were given a single, 45-minute face-to-face education on preventing home accidents. The Mothers' Safety Measures for Home Accidents in Children aged 0-6 were administered the Scale before and one month after the training. The mothers in the control group did not receive any training; the Scale for Identifying Mothers' Safety Precautions for Home Accidents in Children Aged 0-6 was administered during the first interview and again one month later.

Eligibility Criteria:
Inclusion Criteria:

* Mothers with mentally disabled children aged 0-6
* Mothers who agree to participate in the research
* Mothers who agree to be contacted after 1 month for the post-test
* Mothers who know and speak Turkish at the native level

Exclusion Criteria:

* Mothers with mentally disabled children over the age of 6
* Mothers who do not agree to participate in the study
* Mothers who do not agree to be contacted after 1 month for the post-test
* Mothers with mental disabilities
* Mothers who do not know or speak Turkish at the native level
Tolerability of an Anesthesia-free Tonometer Tip

The purpose of this study is to compare the tolerability and comfort of 3 different prototype anesthesia-free tonometer tips with the standard tonometer tip in conjunction with anesthesia. The best-tolerated prototype anesthesia-free tonometer tip will be identified for further development for home tonometry.


Eligibility Criteria:
Inclusion Criteria:

* Presenting for a routine eye exam
* ≥ 18 years of age
* Able and willing to give consent

Exclusion Criteria:

* History of corneal scarring
* Active infection of the eye
* History of alternated corneal sensitivity
* History of corneal surgery
Conduction Disease After Transcatheter Aortic Valve Replacement

This is a prospective single center Cardiology department observational study. The study aim is to better understand the predictors of high grade conduction abnormalities associated with TAVR such that a more robust evidence-based and universal strategy to manage cardiac conduction disturbances in these patients, which has been elusive, can be developed.

TAVR is a very commonly performed procedure throughout the world; it has become standard of care as the treatment for aortic stenosis and is performed in hundreds of thousands of patients annually. TAVR affords patients therapies that prolong life and improve quality of life; furthermore, these therapies afford certain patients who are not candidates for surgical options hope for the future. Adults undergoing TAVR may suffer the complication of requiring a pacemaker after the procedure, in up to 30% of cases. Interventionalists still don't understand how to best predict this complication; in fact some patients that ultimately need a pacemaker don't get one after the procedure and some that get a pacemaker are found to ultimately not have really needed it. A better understanding of which patients do and do not need pacemakers will help prevent complications of high grade block in those without pacemaker (death, syncope and trauma) and also the complications of unnecessary pacemaker implantation (infection, tricuspid regurgitation).

Primary hypothesis: EP studies (EPS), when performed before and after TAVR adds independent incremental value, above and beyond other parameters, for the prediction of high-grade heart block after TAVR. The goal is to understand conduction disease changes before and after TAVR, coupled with other patient and procedural factors that can help create a management algorithm for conduction disease after TAVR.

Primary endpoint: to find correlation coefficients between a) absolute and delta values of various EPS findings, and b) clinical endpoint of high-grade conduction disease as diagnosed clinically, by ECG, by event monitor, or by interrogation of permanent pacemaker implanted after TAVR.

Methods: Patients will receive EPS immediately before and after TAVR (while on the catheterization lab table for TAVR procedure) and then again the next day; this information will help determine whether the patient gets a pacemaker, a 30-day event monitor, or neither. The investigators will study which parameters obtained during the EPS, in addition to other known/suspected predictors of conduction disease after TAVR, best correlate with serious problems with the heart's electrical conduction system as determined by clinical follow-up.

Anticipated findings: that the EPS findings add incremental and independent value in predicting which patients will develop high grade conduction disease.

Eligibility Criteria:
Inclusion Criteria

* Signed and dated Informed Consent
* Patient that undergoes a TAVR
* Ability to complete functional assessments.

Exclusion Criteria:

* Patients with pre-existing permanent pacemaker.
* Patient unwilling or unable to follow-up for necessary pre- and post-procedure clinical assessments.
Intrathecal Enzyme Replacement Therapy for Spinal Cord Compression in Mucopolysaccharidosis (MPS) I

The investigators are studying the use of enzyme replacement therapy into the spinal fluid for treatment of spinal cord compression in the Hurler-Scheie and Scheie forms of mucopolysaccharidosis I (MPS I). Funding source -- FDA OOPD

Enzyme replacement therapy (ERT) has been developed for mucopolysaccharidosis I (MPS I), a lysosomal storage disorder. ERT helps many physical ailments due to the disease, but does not treat the central nervous system, due to inability to cross the blood brain barrier. Our purpose is to test delivery of ERT to the spinal fluid via intrathecal injection in patients with MPS I. In this pilot study, we will use recombinant human α-L-iduronidase administered intrathecally once per month for four months to individuals with the Hurler-Scheie and Scheie forms of MPS I and spinal cord compression. If successful, intrathecal delivery could represent a practical, straightforward method of treating central nervous system disease due to lysosomal storage.

Eligibility Criteria:
Inclusion Criteria:

* Hurler-Scheie,Scheie form of MPS I, of Hurler 2 years after hematopoietic stem cell transplantation
* Spinal cord compression
* Age greater than 8 years
* Able to provide legal informed consent
* Aware of clinical treatment option of observation without treatment or surgical decompression
* Negative urine pregnancy test at screening (non-sterile females of child-bearing potential only)
* Currently using two acceptable methods of birth control (non-sterile females of child-bearing potential who are sexually active only)
* Willing and able to comply with study procedures

Exclusion Criteria:

* Severe (Hurler) form of MPS I
* Desires surgical or medical treatment of spinal cord compression
* Spinal cord compression that warrants immediate surgical intervention
* Pregnancy or lactation
* Hematopoietic stem cell transplantation within 2 years of study enrollment
* Receipt of an investigational drug within 30 days of enrollment
* Infusion reactions to laronidase that required medical intervention, prophylaxis, or altered enzyme administration
* Significant anti-iduronidase antibody titer
* Recent initiation of intravenous laronidase (within past 6 months)
* Presence of cervical subluxation or similar external pathology as the major cause of cord compression symptoms for which surgical intervention should be immediately undertaken
Preop Cooled Radiofrequency Ablation for Total Knee Replacement

Total knee replacement surgery is commonly performed for patients suffering from severe knee osteoarthritis. However, 20% of patients continue to experience pain after surgery. There is currently no standardized pain management protocol for pain after total knee replacement. Cooled radiofrequency ablation has been used successfully to alleviate spin-related pain and has recently been approved by the FDA to treat chronic knee arthritic pain. This pilot study aims to collect preliminary data on the use of cooled radiofrequency ablation in patients undergoing total knee replacement.

The number of patients who undergo total knee replacement is rising significantly. However, many of these patients are dissatisfied with the results, because they continue to experience pain postoperatively. This pain can be debilitating and can also be associated with decreased quality of life. Given the increasing number of patients undergoing total knee replacement and a dissatisfaction rate of 8-44%, improvements must be made in pain management protocols to help decrease pain in the immediate postoperative period following total knee replacement. Cooled radiofrequency ablation is a procedure that uses water-cooled technology to denervate the sensory nerves. It is widely used in the spine and is increasingly being used in the knee to treat osteoarthritis. Existing studies have shown that it can significantly reduce pain in patients with chronic osteoarthritis. In terms of its potential benefit as a preoperative measure to minimize postoperative pain, the literature is sparse. Results from this study will be used to generate hypotheses and power for future studies.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing unilateral primary total knee replacement for osteoarthritis
* Pain \>6 (on a scale of 0-10)
* Body mass index: 21-35 kg/m2

Exclusion Criteria:

* Age \<65 years
* Patients who are wheelchair bound
* History of inflammatory arthritis or rheumatic disease
* Body mass index \<21 or \>35 kg/m2
* Chronic opioid use
* Pregnant women
* Non-English speaking
Early Recognition of Hypoxia in Pediatric Patient Sedation

Early recognition of hypoxia through monitoring in sedation practices in pediatric patients

In pediatric Magnetic Resonance Imaging, sedation is applied to pediatric patients of all age groups from newborn to adolescence in order to prevent the anxiety and movement of the patients during the imaging. It was aimed to compare the capnograph and pulse oximeter used for early detection of hypoxia in patient follow-up and to monitor the depth of sedation with the sedation score in the recovery room.

Eligibility Criteria:
Inclusion Criteria:

* Patients under 18 years of age who underwent magnetic resonance imaging with sedoanalgesia

Exclusion Criteria:

* Patients over the age of 18,
* Those who do not speak Turkish,
* Presence of deformities in the nose and forehead,
* Those with nail polish and henna on their nails
HealthMap: an Interactive Health Plan Randomised Trial to Prevent Cardiovascular Disease in People With HIV

The purpose of this study is to improve the health status of people living with HIV in Australia. The overall goal is to rigorously evaluate the impact of interactive health plans and self-management support on chronic condition outcomes in people with HIV.

The specific aims are to:

Aim 1: Using a doctor-level cluster randomised trial, evaluate the effect of interactive health plans and self-management support on coronary heart disease risk and other chronic condition outcomes in people living with HIV.

Aim 2: Evaluate patient and health care provider experiences and acceptability of interactive health plans and self-management support.

Aim 3: Evaluate intervention cost-effectiveness and effect on health service utilisation.

Participants will be consenting adults 30 years or older without evidence of cardiovascular disease.The study is a pragmatic cluster randomized controlled trial of a complex health system intervention with doctor as the unit of randomization and individual patient outcomes defined as primary and secondary endpoints. The primary endpoint will be assessed in each participant after 12 months of follow up.The study intervention will consist of a programme specifically designed for the Australian clinical context that helps people with HIV and their health care providers achieve best practice targets for modifiable cardiovascular risk factors. The programme will be available to use during routine consultations to present laboratory results, discuss health priorities and describe goals and actions. Patients will be able to access the interactive health plan from home, with associated additional resources, including online peer support. Phone and online health coaching will be available for prioritised patients wanting to reduce their cardiovascular risk. The primary objective is to determine the effect of the intervention on 10-year risk of non-fatal acute myocardial infarction or coronary heart disease death as estimated by the Framingham risk equation. The secondary objective is to alternative cardiovascular risk scores, individual modifiable cardiovascular risk factors, quality of life, mental health, self- management capacity, process and economic outcomes.

Eligibility Criteria:
Inclusion Criteria:

* •HIV infected adults aged 30 years or over.

  * Receiving ongoing primary HIV and general care at a study site and likely to remain in follow up at that site for 12 months.
  * Willing and able to provide written informed consent.

Exclusion Criteria:

* •Diagnosed cardiovascular disease, consisting of coronary heart disease, stroke or transient ischaemia attack, or peripheral arterial disease.

  * Previous participation in a self-management or coaching program.