cyrilzakka/clinical-trials huggingface dataset:
CALM-AD

Primary Aim

To determine whether;

* Donepezil is significantly better than placebo in the management of agitation in Alzheimer's Disease that has not responded to, or is inappropriate for a standardised brief psychosocial treatment

Secondary Aims

To determine whether;

* Donepezil has a significant positive or negative impact upon quality of life compared with placebo
* whether there is a significant difference between Donepezil and placebo with respect to cognitive performance
* the cost effectiveness of the pharmacological treatment for agitation


Eligibility Criteria:
Inclusion Criteria: a diagnosis of dementia consistent with Diagnostic and Statistical Manual of Mental Health Disorders, revised 3rd edition (DSM-III-R) (APA, 1987) National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) diagnostic criteria for probably or possible AD (MKhann et al, 1984) (Appendix 6) clinically significant agitation (defined as causing distress to patient and at least moderate management problems for carers on at least two days per week for a two week period, together with a Cohen Mansfield Agitation Inventory (CMAI) (Cohen-Mansfield, 1986) (Appendix 11 A) score \>39 age \>39 years resident in care facility or community living with a carer not receiving treatment with neuroleptics or cholinesterase inhibitors currently or in the past four weeks and responsible clinician not considering treatment with cholinesterase inhibitor for the next 16 weeks taking into account the clinical evidence base and NICE guideline (NICE, 2001) patient with capacity willing to consent to study or will to participate in study if lacking capacity carer with capacity willing to consent to study and in agreement for patient lacking capacity to participate if patient willing to participate

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Exclusion Criteria:known sensitivity to Donepezil severe, unstable or uncontrolled medical conditions apparent from history, physical examination or investigations current evidence of delirium patient meets criteria for Probably Dementia with Lewy Bodies (McKeith et al, 1996) low probability of treatment compliance

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Pilot Study of Pregnenolone Augmentation Targeting Cognitive Symptoms in Persistently Symptomatic Patients With Schizophrenia

This is a pilot study of pregnenolone as an augmentation treatment for schizophrenia. The goal of this placebo-controlled study is to provide preliminary efficacy data for potential pregnenolone effects on cognitive symptoms and negative symptoms in patients with schizophrenia. Depressive symptoms and positive symptoms will also be assessed.

See brief summary

Eligibility Criteria:
Inclusion Criteria:

1. 18-65 years of age, any ethnic group, either sex
2. Diagnostic and Statistical Manual, 4th edition (DSM IV) diagnosis of schizophrenia or schizoaffective disorder
3. Ability to participate fully in the informed consent process, or have a legal guardian able to participate in the informed consent process.
4. Patient cohort enriched for moderate to severe cognitive symptoms (composite Brief Assessment of Cognition in Schizophrenia (BACS) score 0-3 SD below the mean).
5. No change in antipsychotic for 8 weeks or longer. No change in antipsychotic dose for 4 weeks or longer.
6. No change in anticholinergic, benzodiazepine, or mood stabilizer medications for 4 weeks or longer.
7. No anticipated need to alter any of the above medications (antipsychotics, anticholinergics, benzodiazepines, or mood stabilizers) for the 10-week duration of the study.

Exclusion Criteria:

1. Unstable medical illness or neurologic illness (seizures, cerebrovascular accident); history of prostate, breast, uterine, or ovarian cancer.
2. Use of oral contraceptives or other hormonal supplementation such as estrogen.
3. Other concomitant medications for medical conditions will be addressed on a case-by-case base to determine if exclusionary.
4. Active expression of suicidal or homicidal ideation.
5. Comorbid substance dependence (other than nicotine dependence), or presenting symptoms likely substance-induced, as judged by a study physician.
6. Female patients who are pregnant or breast-feeding.
7. Known allergy to study medication.
8. Drugs with a narrow therapeutic index (e.g. thioridazine, mesoridazine, ziprasidone, clozapine, etc) will be excluded as suggested by the Federal Drug Administration (FDA); patients taking these agents will not be eligible for this study.
The Healthcare Evaluation of Absolute Risk Testing Study

The aim of this study is to demonstrate the integration and use of cardiovascular disease (CVD) integrated risk tool (IRT) in an environment as close to real-world as possible.

This study will recruit participants of both biological sexes and any ancestry or background who require and are eligible for a CVD risk assessment as part of the NHS Health Check. Those aged 45-64 years are most likely to benefit from CVD IRT and will be included in the study, as they are more likely to be asymptomatic but also derive most benefit from preventative measures.

The study will be conducted in GP surgeries as the CVD IRT will have its greatest impact if incorporated into primary care practice for early identification of patients at highest risk.

This study is a device performance evaluation.

The aim of this study is to demonstrate the integration and use of a cardiovascular disease (CVD) integrated risk tool (IRT) in an environment as close to real-world as possible.

In association with the routine healthchecks for CVD, the QRISK score will be integrated with the individuals polygenic risk score (from a blood sample) to produce the CVD IRT score, this score estimates the risk of CVD in the following 10years.

This study will recruit participants of both biological sexes and any ancestry or background who require and are eligible for a CVD risk assessment as part of the NHS Health Check. Those aged 45-64 years are most likely to benefit from CVD IRT and will be included in the study, as they are more likely to be asymptomatic but also derive most benefit from preventative measures.

The study will be conducted in GP surgeries as the CVD IRT will have its greatest impact if incorporated into primary care practice for early identification of patients at highest risk.

This study is a device performance evaluation. 1000 participants are expected to be enrolled. Of this, it is expected that 200 surveys will be completed and from those surveyed 20-30 interviewed. This would be considered an adequate determination of feasibility.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to provide written informed consent and to comply with the study protocol
* Either male or female (biological sex)
* Aged 45-64 years (inclusive)
* Any ancestry or background
* Eligible for NHS Health Check using QRISK®2 assessment

Exclusion Criteria:

* Those excluded from NHS Health Checks;
* Currently prescribed and taking HMG-CoA reductase inhibitors (lipid-lowering preventive treatments or statins) for any indication.
Communication Intervention Physical Activity

The project is a two-arm randomized clinical trial to pilot the feasibility of a communication training intervention for primary care clinicians, linked to a community program referral, on use of the 5As to promote physical activity in underserved patients.

This study will focus on training clinicians to communicate effectively using the 5As and patient-centered communication skills (Aim 1). When implemented fully, the intervention will also include referral to a community fitness program. Clinicians will be randomly assigned to two groups (1 and 2). Group 1 will participate in the training intervention first; group 2 will act as a wait-list control for Group 1. The primary outcome, the effectiveness of the intervention on clinician use of the 5As during routine office visits, will be measured by examining 371 audio-recorded patient visits prior to, immediately, after, and 6 months after the clinician is trained. Secondary outcomes include whether the communication training intervention improved patients' perceived competence to adopt physical activity (Aim 2)and whether clinicians believe that the communication intervention addressed pertinent barriers to promoting exercise (Aim 3). Exploratory outcomes (Aim 4) will \[assess potential mediators of the intervention's effect, examine the effect of the intervention on actual physical activity levels in a subset of participants, and create a taxonomy of communication markers for each of the 5As.\]

Eligibility Criteria:
Inclusion Criteria:

* Current patients at Westside Health Services
* Be scheduled for a routine, follow-up or health maintenance office visit
* Be practicing clinicians (physicians, physician asst. or nurse practitioner

Exclusion Criteria:

* Have life-threatening acute medical problem which precludes participation
* Unable to read and understand English
* Already achieving recommended level of physical activity
* Planning to move or relocate (clinicians) to another practice in the study period
* Serving as study investigators, consultants, or advisors
The SMARTER Cardiomyopathy Study

Cardiomyopathies are diseases of the heart muscle. Known genetic factors may account for some cardiomyopathy cases but there is still much to understand about the genetic and environmental causes and how the disease progresses.

Finding new ways to diagnose and treat cardiomyopathies could improve the health and well-being of patients with these conditions.

This study will collect data from individuals with cardiomyopathy or related heart muscle disease, or with a possible genetic predisposition to cardiomyopathy, and follow them over time to observe the progress of their heart and health. This study will collect DNA, blood samples, and detailed clinical \& lifestyle information at the start of the study, and data collected during routine healthcare visits over time.

* learn what causes cardiomyopathy, and therefore how to treat it
* understand why cardiomyopathy progresses differently in different people, to improve the ability to recognise who will benefit from different treatments at different times

The investigators will collaborate with other centres internationally to collect a large of group of participants with similar cardiomyopathies, providing power to identify new pathways that cause disease and ways of predicting which participants are at risk of having more severe disease.


Eligibility Criteria:
Inclusion Criteria:

Adults with the capacity to consent Children with parental/guardian consent Male and Female

Meeting the following criteria:

1. Patients with a confirmed diagnosis of cardiomyopathy or related condition
2. Patients with a family member with cardiomyopathy, or a related condition
3. Patients with a genetic variant that may predispose to cardiomyopathy, or a related condition

Exclusion Criteria:

Patients without the capacity to provide informed consent
Eliciting Perceived Norms About Substance Use

Survey experiment to elicit perceived norms about substance use

Health behaviors and health risk behaviors are known to be associated with the extent to which one perceives these behaviors as normative. The canonical example of this phenomenon is taken from the U.S. literature, which has robustly shown that undergraduate students on college campuses tend to drink more heavily and frequently if they believe their classmates drink heavily and frequently, irrespective of their classmates' actual levels and frequency of use. However, there remains little systematic understanding about the best ways to elicit these perceived norms through survey-based research studies. This randomized survey experiment compares different ways of eliciting perceived norms.

Eligibility Criteria:
Inclusion Criteria:

* All adults who consider Nyakabare their primary place of residence and who are capable of providing consent

Exclusion Criteria:

* Minors younger than 18 years of age, with the exception of emancipated minors
* Persons who do not consider Nyakabare Parish their primary place of residence, e.g., persons who happen to be visiting Nyakabare at the time of the survey or who own a home in Nyakabare but spend most of their time outside the parish
* Persons with psychosis, neurological damage, acute intoxication, or other cognitive impairment (all of which are determined informally in the field by non-clinical research staff in consultation with a supervisor)
Ultrasound-Guided Suprazygomatic Maxillary Nerve Block as A Part of Multimodal Analgesic Regimens

Inadequate peri-operative analgesia may contribute to an increased risk of bleeding, suture dehiscence and unacceptable surgical outcomes. Moreover, these patients are at high risk of postoperative airway obstruction and respiratory failure.

Opioids may contribute to these complications. Appropriate use of regional anaesthesia may mitigate or eliminate many of these concerns. The maxillary nerve is responsible for the sensory innervation of the midface, including the hard and soft palates, upper jaw, upper dental arch and upper lip.Recently, the successful use of maxillary nerve block by the suprazygomatic approach has been reported in children undergoing cleft palate surgery. However, the use of this block has not been described in large series of patients, and the effectiveness of the suprazygomatic approach has not been evaluated in patients undergoing tonsillectomy .


Eligibility Criteria:
* Inclusion criteria

  1. Pediatric patients aged 4-12 years
  2. Genders eligible for study: both sexes
  3. ASA physical status I and II
  4. Undergoing tonsillectomy surgery

     Exclusion criteria
* Parents' refusal
* Contraindications to regional anesthesia
* Known allergy to local anesthetics
* Bleeding disorders
* Children with diabetes mellitus, obstructive sleep apnea syndrome, cardiac, renal, liver or blood diseases, swallowing disorders or peritonsillar abscess,
* Children receiving regular analgesia within the last week before surgery,
* Children undergoing simultaneous procedure in the field of surgery like adenoidectomy or tongue tie will be all excluded from the study.
The Effects of Anaesthesia on Cerebral Oxygenation and Cognitive Function in Carotid Endarterectomy

Volatile anesthetics interfere with cerebral blood flow and reperfusion-ischemia injury via the mechanism known as a preconditioning. A transient deterioration of local hemodynamics and oxygenation during carotid endarterectomy (CEE) might involve both hemispheres of brain and affect postoperative cognitive function. The goal of this study was to assess the effects of anesthetics on perioperative cerebral oxygenation and cognitive functions.

Background: A transient deterioration of cerebral hemodynamics and oxygenation during CEE might involve both hemispheres of the brain and affects postoperative cognition. Despite some benefits of regional blocks, the majority of procedures of carotid endarterectomy (CEE) are performed under general anaesthesia. Surprisingly, the studies comparing the effects of sevoflurane and propofol on postoperative mental state in CEE are scarce and controversial. While propofol possesses some anti-inflammatory properties, volatile anesthetics can interfere with cerebral blood flow and reperfusion-ischaemia injury via the mechanism of pre- and postconditioning. The goal of this study is to assess the effects of the anesthetics on the perioperative cerebral oxygenation and cognitive functions in CEE.

Methods: The study and informed consent are approved by the Ethical Committee of the Northern State Medical University. Forty patients (males only) who are to undergo elective CEE will be included into a prospective study and randomised to two groups receiving either total intravenous anaesthesia (TIVA group, propofol + fentanyl) or the volatile induction and maintenance of anaesthesia (VIMA group, n = 20, sevoflurane + fentanyl). All patients were operated using temporary carotid bypass. Invasive arterial pressure (AP), gas exchange, and cerebral tissue oxygen saturation (SctO2, ForeSight, CAsMed, USA) over frontal region for ipsilateral (SctO2IPSI) and contralateral (SctO2CONTR) hemispheres were registered during the surgery and up to 20 hrs of the postoperative period. The cognitive changes will be assessed at 12 hrs before as well as on Days 1 and 5 after CEE by blinded investigator using Montreal Cognitive Assessment score (MoCA).

Data will be presented as median (25-75th percentiles). Intergroup comparison will be provided with Mann-Whitney U-test and correlation analysis with Spearman's coefficient (rho). P value below 0.05 was regarded as statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* Male gender
* Informed consent
* Symptomatic carotid stenosis \> 75%

Exclusion Criteria:

* Contralateral carotid occlusion
* Known allergy to the one of the compared medications
An RCT to Compare the Outcomes of Patients With Large Rotator Cuff Repair That Undergo Repair With or Without SIS

The prognosis for patients with large rotator cuff tears is poor. This recently developed biologic scaffold provides numerous structural and functional properties that may direct cell growth and aid in tendon healing. To date, there are no randomized clinical trials assessing the effectiveness of the patch to augment repairs of large rotator cuff tears. We propose a study to compare the rate of repair failure, quality of life, function, pain, and range of motion in 60 patients with large rotator cuff. Patients will be randomized (like flipping a coin) to undergo a standard rotator cuff repair with or without augmentation with SIS. Patients are assessed at 6 weeks, 3, 6, 12, 18, and 24 months post-operative

Objective of the full randomized trial To compare the effectiveness of a standardized method of rotator cuff repair with or without augmentation using porcine small intestine submucosa (SIS) in patients with large rotator cuff tears.

Objectives of the pilot study

1. To obtain a preliminary estimate of the likely success of SIS.
2. To formally evaluate our ability to successfully recruit eligible patients into this study.
3. To determine appropriate length of follow up through examination of the pattern of incremental improvement and stabilization of quality of life over time following rotator cuff repair.
4. To determine a more accurate estimation of sample size for the full trial using quality of life.
5. To determine the frequency with which surgeons comply with the surgical protocol.
6. To determine the frequency with which patients and physiotherapists comply with the suggested physiotherapy protocol.

Eligibility Criteria:
Inclusion Criteria:

Patients with large rotator cuff tears (Type 1B or Type 2) determined by clinical examination and diagnostic imaging. Criteria described by Harryman et al (1991) will guide the classification of rotator cuff tears defined and reassessed at the time of surgery (Type 0 = intact cuff, Type 1A = thinned cuff or partial thickness defect, Type 1B= full thickness defect on one tendon, Type 2 = full thickness defect of two tendons, Type 3 = full thickness defect of three tendons).

Exclusion Criteria:

* Previous shoulder surgery, excluding acromioplasty or diagnostic arthroscopy.
* Inability of the surgeon to repair the tear with remaining defect no greater than 10mm in diameter,
* Inability of the surgeon to repair the tear with less than 1cm of medialization,
* Evidence of other significant shoulder pathology including, Type II-IV SLAP lesion, Bankart lesion, Hill Sachs lesion, Grade III osteoarthritis).
* Active joint or systemic infection,
* Significant muscle paralysis of the shoulder girdle,
* Major medical illness that would preclude undergoing surgery,
* Patients who are unwilling or unable to be assessed according to study protocol for one year following surgery
* Major psychiatric illness, developmental handicap or inability to read and understand the English language
Essure (Model ESS310) Placement Rate Study

To evaluate the safety and successful placement rate of Essure Model ESS310 device and any factors that may influence the successful placement rate of this device.


Eligibility Criteria:
Inclusion Criteria:

* Females aged range 21 to 44 years
* Subjects seeking permanent contraception
* Subjects with body weight within range of 90-300 pounds (40 - 136 kilograms)
* Subjects for whom medical history indicates bilateral viable and patent fallopian tubes
* Subjects are able and willing to comply with the protocol required follow-up visits
* Subjects have fulfilled local requirements for counseling and consent to contraception and sterilization, including any required waiting periods
* Subjects provide written informed consent prior to enrolment
* Subjects who have sufficient mental capacity to understand the informed consent form (ICF), comply with the protocol requirements, and provide clinically relevant and reliable feedback regarding their experience implant and subsequent wearing of the device
* Subjects who agree that anonymized personal data will be made available to study Sponsor and requisite regional and international regulatory bodies

Exclusion Criteria:

* Subjects suspected of being or confirmed pregnant
* Subjects post-partum or undergone pregnancy termination ≤6 weeks of scheduled insert placement
* Subjects who have known proximal tubal occlusion in either fallopian tube
* Subjects who have undergone fallopian tube sterilization procedure
* Subjects who have had total or partial salpingectomies
* Subjects diagnosed with tubal, endometrial, or myometrial pathology which may prevent fallopian tube ostia access
* Subjects diagnosed with unicornuate uterus
* Subjects diagnosed with active or currently being treated upper or lower pelvic infection
* Subjects with gynecologic malignancy
* Subjects who are currently taking corticosteroids
* Subjects with a known allergy to all contrast media available for use in HSG (Hysterosalpingogram)
* Subjects scheduled to undergo concomitant intrauterine procedures at the time of insert placement (e.g., endometrial ablation, fibroid resection by hysteroscopy, endometrial polypectomy). Intrauterine device removal is not considered a concomitant procedure.
* Subjects with any general health condition or systemic disease that may represent, in the opinion of the physician, a potential increased risk associated with device use or pregnancy
* Subjects with a close affiliation with the investigational site, e.g. closely related or affiliated with the investigator (such as dependent, employee or student of the investigational site, or sponsor's staff)