cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Preoperative Prehabilitation With a Home-based Supervised Exercise Program Against an Unsupervised Exercise Program for Frail Elderly Patients Undergoing Major Abdominal Surgery

Singapore's population is ageing, and more elderly people are undergoing elective major surgeries. Frail elderly experience greater functional decline and slower recovery in physical function after surgery compared to non-frail elderly. Preoperative prehabilitation aims to enhance both aerobic capacity and physical strength of elderly to attenuate the post-operative decline in physical function. Singapore General Hospital has a bespoke preoperative program - Prehabilitation for Elderly Frail Patients Undergoing Elective Surgeries (PREPARE), where patients receive physiotherapy education and instructions for home-based unsupervised exercise program (uSEP). A hospital-based supervised exercise program had also been established but the take-up rate was low (7.6%) due to barriers such as cost and accessibility. Perioperative supervised exercise training can effect greater gains in functional capacity and muscle strength compared to no supervision. For the elderly with limited transport options to the hospital, home-based supervised programmes may be more convenient compared to hospital-based supervised programmes, but the former is costlier too. Home-interventions may also empower patients with the skills and confidence to maintain their physical fitness at home, which increases their likelihood of exercising after surgery.

The investigators propose a prospective single-center randomized controlled trial to evaluate the efficacy of preoperative prehabilitation with a home-based supervised exercise program (SEP) for frail elderly patients undergoing major abdominal surgery, compared to the mainstay of clinical practice, which is a home-based uSEP.


Eligibility Criteria:
Inclusion Criteria:

* 1. Elective major abdominal surgery
* 2. Lead time \>= 14 days to surgery
* 3. Edmonton Frail Scale total score \>= 6 points or Functional performance score (Timed up and Go(TUG)) \>= 1 point

Exclusion Criteria:

* 1. Inability to provide written informed consent due to cognitive impairment
* 2. Having Comorbid medical conditions interfering with the ability to perform exercise at home or to complete the testing procedures. These include: i. Unstable cardiac conditions ii. Acute illnesses iii. Patients who are completely unable to walk
Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain

To evaluate the efficacy of three doses of quinagolide administered as an extended-release vaginal ring compared to placebo on reduction of moderate to severe endometriosis-related pain


Eligibility Criteria:
Inclusion Criteria:

* Pre-menopausal females aged ≥18 years at time of signing informed consent(s) with regular menstrual cycles.
* Body mass index (BMI) of 18-42 kg/m2 (both inclusive) at screening.
* Initial confirmation of endometriosis by laparoscopy or laparotomy within the last 10 years before the run-in visit or visualization of persistent endometrioma by repeat ultrasound.
* Transvaginal ultrasound documenting a uterus with no clinically significant abnormalities and presence of at least one ovary with no clinically significant abnormalities (with the exception of endometrioma) at the run-in visit.
* Eligible participants experienced moderate to severe endometriosis-related pain, which was defined as at the run-in visit, the participant having an NRS score of ≥5 for the worst endometriosis related pain during the past menstrual cycle and at randomization, the participant having a mean daily NRS score of ≥4 for the worst endometriosis related pain during each run-in menstrual cycle.

Exclusion Criteria:

* History of no relief of endometriosis related pain after any medical therapy or surgery. However, history of partial pain relief, discontinuation due to side effects are not exclusionary.
* Known bone diseases (e.g. osteoporosis, Paget's disease and osteomalacia) affecting bone resorption or bone formation markers.
* Any significant abnormal findings of heart examinations before randomization.
* History of mental illness including occurrence of acute psychosis, bipolar disorders and schizophrenia (except for well-controlled anxiety and/or depression with no changes to interventions for 6 months prior to start of run-in)
* History of impulse control disorders including pathological gambling, compulsive buying, hypersexuality, and binge eating or being identified with potential impulse control disorder by the questionnaire for impulsive-compulsive disorders (a score ≥2 for any sub-questions of Question 3 or a score ≥1 for any sub-questions of Question 4) prior to randomization.
* History of orthostatic hypotension or recurrent syncope.
Cochlear Implant Low Power Strategy

Reducing power consumption in the cochlear implant is crucial to the development of future smaller sound processors. The commercial MP3000 sound coding strategy has been shown to be more efficient in power consumption to the standard ACE strategy. However in order to develop smaller sound processors, further battery life power savings are required. The aim of this study is to evaluate three experimental sets of MP3000 parameter sets, compared against the default ACE program. In the background for each of the four strategies, experimental noise reduction programs (SpatialNR and NR3) will also be in use. In an additional phase of the study, low stimulation rate ACE programs will also be evaluated against the default stimulation rate.


Eligibility Criteria:
Inclusion Criteria:

1. Adult (\>18 years) cochlear implant recipients
2. Implanted with the CI500, CI24RE and Nucleus 24 Series and CI422 cochlear implants.
3. User of commercially available Freedom, CP810 or CP900 series sound processor
4. User of the ACE strategy or MP3000 strategy
5. At least 3 months experience with the cochlear implant
6. Native speaker in the language used to assess speech perception performance
7. Willingness to participate in and to comply with all requirements of the protocol

Exclusion Criteria:

1. Additional handicaps that would prevent participation in evaluations
2. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device
Leuven Interactive Scheme for hearingTraining Evaluation, and Audiological Rehabilitation

It is believed that persons with hearing impairment benefit from auditory rehabilitation (AR), i.e. regular assessment and training of their listening skills. However, the efficacy of auditory rehabilitation has not been investigated before. In Leuven (Belgium) an e-health app has been developed that enables performance assessment, listening skills training, and counselling for persons with hearing impairment. Currently, an RCT is prepared to evaluate the different modules in persons with hearing impairment. The experimental group will receive auditory rehabilitation training modules, and a control group will either receive training tasks that are NOT believed to transfer to improved listening skills or will not receive any training (passive control).

1. Do participants improve on the trained tasks in the LUISTER AR scheme and does this improvement transfer to an improvement in speech perception in noise (primary outcome), executive functioning and/or quality of life (secondary outcomes)?
2. Does training with the LUISTER AR scheme provide more benefit on primary and secondary outcomes than a placebo program (active control group) or no training (passive control group)?
3. Can improvement in speech in noise perception, obtained with the LUISTER AR scheme, be consolidated until 6 months after training has stopped?
4. Are certain user-specific or training-specific aspects correlated to improvement on task-specific learning as well as near- and far transfer

Goals of the study:

To determine an optimal, personalized AR scheme (considering age, degree of HI) and possible interacting factors (e.g., training time, type of errors)

To investigate transfer of auditory and auditory-cognitive training to listening skills in everyday life

To develop evidence-based guidelines for clinical AR

A study to assess the efficacy in CI users will start with baseline assessment (speech in noise understanding, LIST sentences and cognitive tests (executive functioning, important for listening skills). This will be followed by 8 weeks of training, an intermediate assessment moment, again 8 weeks of training, and a final evaluation moment. After 6 months follow-up evaluation to investigate retention. This study is comprised of an active training group and an active control group.

A study to assess the efficacy in HA users will start with baseline assessment (speech in noise understanding, LIST sentences and cognitive tests (executive functioning, important for listening skills). This will be followed by 6 weeks of training, an intermediate (online) assessment moment, again 6 weeks of training, and a final evaluation moment.

Eligibility Criteria:
Inclusion Criteria:

* hearing impaired
* sufficient knowledge of the Dutch language

Exclusion Criteria:

* cognitively impaired
Testing Adaptive Physical Activity in Stroke

"Testing Adaptive Physical Activity in Stroke" tests the idea that adaptive physical activity (APA) will improve fitness, balance and walking function, daily step activity, and outcomes related to quality of life in individuals with chronic stroke. Adaptive physical activity is an exercise model that combines aerobic exercise with balance and gait training in a socially reinforcing group setting. Individualized homework assignments encourage integration of exercise into daily life routines. Our specific aims are:

1. to determine whether APA improves cardiovascular fitness and metabolic health
2. to measure the effects of APA on gait and balance, ambulatory activity, and ADL function
3. to determine whether APA affects self-reported outcomes related to self-efficacy, fatigue, and stroke-specific quality of life


Eligibility Criteria:
Inclusion Criteria:

1. Ischemic stroke greater than or equal to 6 months prior in men or women ages 40- or older. Hemorrhagic stroke greater than or equal to one year prior in men or women ages 40-or older.
2. Residual hemiparetic gait deficits.
3. Already completed all conventional inpatient and outpatient physical therapy.
4. Adequate language and neurocognitive function to participate in exercise testing and training (specific screening instruments used.)
Impacts of a Combined Berry Extract Supplement on Vascular Function and Oxygen Utility Capacity in Young Adults

The purpose of this study is to investigate the impacts of a combined berry extract supplement (hawthorn berry, tart cherry, and bromelain extracts) on total antioxidant capacity, endothelial function, blood pressure, oxygen utility capacity, and fatigue index in healthy young adults.

There are several proposed mechanisms that are thought to contribute to the development of cardiovascular diseases. Although the process is extremely complex, it is well-accepted that elevated levels of reactive oxygen species (ROS) production and inflammation contribute to the systemic vascular dysfunction in cardiovascular diseases. These factors often partially contribute to endothelial dysfunction, elevated blood pressure, reduced oxygen utility capacity, and reduced muscle function. Therefore, by reducing ROS and inflammation, there may be protective effects against vascular dysfunction and thus protection against cardiovascular disease manifestation. Intake of natural anthocyanins and polyphenols derived from fruits and vegetables has been shown to reduce excessive ROS and inflammation in several populations.

Therefore, the purpose of this study was to investigate the impacts of a combined berry extract supplement (hawthorn berry, tart cherry, and bromelain extracts) on total antioxidant capacity, endothelial function, blood pressure, oxygen utility capacity, and fatigue index in healthy young adults.

Eligibility Criteria:
Inclusion Criteria:

* otherwise healthy adult

Exclusion Criteria:

* cardiovascular disease
* neurological disorder
* metabolic disorder
* respiratory disorder
* renal diseases
* musculoskeletal injury
* bleeding disorder
* allergy to fruit
* pregnant/breast feeding
* taking daily medication (prescription or over-the-counter)
Long-term Effects of Intensive Insulin Treatment in Type 1 Diabetes

To investigate long-term effects on cardiovascular mortality/morbidity and renal failure in type 1 diabetes patients former randomized to intensive insulin treatment

The Stockholm Diabetes Intervention Study (SDIS) aimed to determine whether intensified insulin treatment were feasible and led to less serious diabetic complications. 102 patients with type 1 diabetes mellitus were randomized (October 1982 to March 1984) to intensified conventional treatment (ICT; n=48) or standard treatment (ST; n=54). The randomized SDIS study lasted for 7.5 years, whereas 96 patients were fully evaluated. Thereafter patients were assigned to their regular clinical visits.

In the present interventional study we wanted to study all-cause mortality and cardiovascular outcomes (i.e. myocardial infarction and stroke), and renal failure in the SDIS cohort until december 31 2011.

Eligibility Criteria:
Inclusion Criteria:

* Born 1930 or later
* Type 1 diabetes
* Nonproliferative retinopathy
* Normal serum creatinine
* Unsatisfactory blood glucose control

Exclusion Criteria:

* Alcohol/drug abuse
* Proliferative retinopathy
Zirconia Versus Lithium Di-silicate Overlays for Restoring Hypomineralized Molars Affected With MIH

the study evaluate the clinical outcome of zirconia versus lithium disilicate overlays restorations for restoring vital young permanent first molar teeth affected with moderate form of molar Incisor hypomineralization: randomized clinical trial.

To compare the one-year clinical outcome of zirconia versus lithium disilicate overlays restorations. Materials and methods: Twenty patients were distributed into two groups in relation to the material used for the fabrication of overlays restorations; group (Z) (n=10): patients received zirconia restorations, group (EC): patients received IPS E.max Cad restorations. Clinical and radiographic evaluations of these restorations were carried out at base line (1 week), 3, 6 and 12 months after cementation using FDI World Dental Federation criteria

Eligibility Criteria:
Inclusion Criteria:

* Children's age ranging from 10 to 15 years old.
* Existence of large carious lesion in young permanent first molar teeth associated with weak cusps.
* Signs of vital pulp without symptoms of pulpitis.
* Presence of antagonists and adjacent teeth and occlusal contacts with good level of oral hygiene.
* Children should be able to physically and psychologically tolerate conventional restorative procedures.

Exclusion Criteria:

* Children with poor oral hygiene and symptoms of pulpitis.
* Children suffer from parafunctional habits.
* Children with any debilitating systemic disorder.
Impact of Peri-Operative Hyponatremia on Postoperative Outcomes in Major HPB Surgeries for Cancers

The present study is being designed to study the impact and predictive nature of perioperative hyponatremia on post operative outcomes in patients undergoing Major HPB surgeries for cancers. Major hepatobiliary-pancreatic surgeries will be defined as follows-

* Pancreaticoduodenectomy,
* Hemihepatectomy or greater with or without caudate lobectomy
* Extrahepatic bile duct resection
* Extended cholecystectomy
* Distal Pancreatectomy with or without splenectomy The primary Objective of the study would be to compare post operative major morbidities and early mortality (\<90 day) in major HPB surgeries done for cancer patients with and without peri-operative hyponatremia. (\<135mmoL/L). Development of systemic complications and long term outcomes (overall survival and disease free survival) will also be evaluated.

It will be an observational study consisting of both, a retrospective arm and a prospective arm. All consecutive patients undergoing major HPB surgery from 2010 till 30th June 2024 will be included in the study.

Primary objective: To compare post operative major morbidities and early mortality (\<90 day) in major HPB surgeries done for cancer in patients with and without peri-operative hyponatremia. (\<135mmoL/L)

Secondary objectives: To compare the following in patients undergoing major HPB surgeries for cancer in patients with and without peri-operative hyponatremia (\<135mmoL/L)

* Post operative Systemic complications and
* Long term outcomes

  * OS- POD1 till death/ last follow up (30th Sep 2024).
  * DFS- Surgical resection till first detected recurrence of cancer or last follow up (30th Sep 2024) without recurrence.
* Study design- Observational study- Retrospective and prospective.
* Study period- Data collection will be done from time of ethical clearance till 30th June 2024.
* Intervention - None
* Monitoring and assessment- Clinical profile of the patient and symptoms will be serially followed during the patients post operative OPD visits.
* STATISTICAL ANALYSIS:

  1. Continuous variables- with Student t test and Mann Whitney U test as appropriate.
  2. Categorical data - Chi square or Fischer exact test. Besides the above, appropriate analysis will be done at the time of final data analysis.
  3. Significance will be seen at 5 % level (p\<0.05).
  4. Adequate subgroup analysis and multivariate regression analysis will be done.
* Adverse effects - No adverse effect is expected to occur out of the study protocol.
* Stopping rule - Not Valid

Eligibility Criteria:
Inclusion Criteria:

1. All patients undergoing major HPB cancer surgeries at ILBS from 2010 till 30th June 2024.

Exclusion Criteria:

1. Presence of diuretic (Thiazide, Frusemide), pain killer (Indomethacin, Ketorolac) induced preoperative hyponatremia.
2. Patients with peri-operative diarrhea and vomiting due to infective cause leading to hyponatremia.
3. Patients who did not have a preoperative serum sodium level recorded within 72 hours prior to surgery.
4. Minor HPB cases.
Validation Study of the Performance of the French Version of the Autism Mental Status Examination Scale as a Tool for Identifying Autism Spectrum Disorder in Adults

To improve diagnosis of Autism Spectrum Disorder (ASD), expert centers have been set up in France since 2000/2010. However, waiting times in these centers are long, mean of 19 months for adults, and more than half the people seen do not end up with an ASD, even though referral by a psychiatrist is increasingly required.

Therefore, validated diagnostic tools for screening before referral are needed. The Autism Mental Status Exam (AMSE), a 8-item tool, which is quick and easy to use, appears to have excellent sensitivity (0.91) and specificity (0.93). However, this tool was only evaluated when used by experts and on a sample of 50 patients.

The hypothesis of this study is that the AMSE, used by non-expert psychiatrists, has sufficiently good diagnostic performance (minimal sensitivity and specificity of respectively 93% and 65%) to be used in screening adults with suspected ASD.

Patients who contact one of the expert centers participating in the study for an ASD diagnostic evaluation are first referred, as in usual care, to a non-expert psychiatrist or psychologist (from a list of professionals provided by the center and previously trained to the AMSE) to complete a pre-evaluation file. For the study the AMSE and a brief AMSE-filling guide is added to the file.

Seven days to 12 months after, patients have a 2-day (consecutive or separated by a maximum of 2 months) full ASD evaluation in the expert center with a final diagnosis made by the expert multidisciplinary team according to Diagnostic and Statistical Manual (DSM)-5 criteria for ASD.

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age or older
* Patient who has requested, on his or her own or through a relative, a diagnostic evaluation in an expert center for the diagnosis of ASD.
* Patient covered by national health insurance

Exclusion Criteria:

* Patient with a previous ASD diagnostic evaluation
* Patient with a previous AMSE assessment
* Absence of informed consent (patient or his/her legal guardian)
* Pregnant or breast-feeding
* Patient deprived of freedom
* Non-French-speaking patient and/or parents and/or legal guardians
* AMSE not, incorrectly or inadequately completed by non-expert psychiatrist or psychologist
* Patient covered by Aide Medicale d'Etat (AME)
Offsetting Hippocampal Degeneration in m-sTBI

The goal of this study is to establish the feasibility of an intervention designed to improve memory in patients who have experienced a moderate or severe traumatic brain injury (m-sTBI) and to examine its effect on brain structures.

The purpose of this study is to establish the feasibility of a novel intervention, and explore biomarker predictors of neurodegeneration and response to the proposed intervention. This 16 week intervention utilises allocentric spatial navigation tasks to improve memory and counteract hippocampal neurodegeneration. This intervention will be administered in combination with neuropsychological assessments, MR imaging, and the analysis of genomic variants at two time points; 7 months post-TBI and 12 months post-TBI.

Eligibility Criteria:
Inclusion Criteria:

* An acute care diagnosis of TBI as determined by a medical professional, indicated by:

  * Post-traumatic amnesia duration of 24 hours or more, and/or lowest Glasgow Coma Scale score of \< 13
  * Positive clinical CT or MRI scan
* Aged 18 to 65
* Fluent in English
* Have the competency for fully informed consent by 6 months post-injury
* Have basic computer skills
* Have functional use of one upper extremity
* Have access to the internet

Exclusion Criteria:

* A neurological disorder other than TBI (e.g., stroke, dementia, tumor, neurodevelopmental disorder) impairing baseline awareness, cognition, or validity of follow-up and outcome assessment.
* A systemic condition (e.g., lupus, diabetes, rheumatoid arthritis).
* Any contraindications to magnetic resonance imaging (MRI)
* You are experiencing language impairments (i.e., aphasia) from your injury