cyrilzakka/clinical-trials huggingface dataset:
Adapting and Implementing the I-HoME Intervention in Caregivers of Patients With ADRD

The purpose of this study is to pilot test the adapted Improving Home hospice Management of End-of-life issues through technology (I-HoME) intervention with family caregivers of patients with advanced Alzheimer's Disease and related dementia. Data will be collected regarding intervention feasibility and acceptability.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old and \< 100 years
* English speaking
* Providing care to an ADRD patient who is age ≥ 65 years old and \< 105 years who is a stage 7a-f on the Functional Assessment Staging Tool (FAST) scale

Exclusion Criteria:

* Non-English speaking
* \<18 years old or \>100 years old
Setting up a Cohort of Patients With Crohn's Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease

The objective of this study is to constitute cohorts of Crohn versus non-Crohn patients to identify (a) new biomarker(s) of intestinal dysbiosis associated with Crohn disease, and develop a prototype for assaying such marker(s) in blood.


Eligibility Criteria:
Inclusion Criteria:

General criteria:

* Male or female ≥ 18 years old
* Able to follow the instructions of the study
* Having signed an informed consent

Specific for Crohn cohort:

* A confirmed diagnosis of CD
* Colonic or ileocolic involvement
* Patients with CD presenting inflammatory flare and disease extent in the colon or ileocolic region with:
* A clinical activity defined by an average of four or more instances of very soft or liquid stools daily or an abdominal pain score of 2 or more OR a CDAI (CD Activity Index) ≥ 220 OR a Harvey-Bradshaw Index \> 8 OR a faecal calprotectin ≥ 250 µg/g And
* A endoscopic activity defined by a SES-CD (Simple Endoscopic Score for Crohn Disease) ≥ 6 or a CDEIS (CD Endoscopic Index score) ≥ 7

Specific for Control cohort:

Patient with no colonic lesion(s) visible during the endoscopical examination (neither Crohn's nor other colitis nor cancer)

Exclusion Criteria:

General criteria:

* Commercial Pharmaceutical probiotic administration within the previous month
* Treatment with antibiotics (whatever the route of administration) within last 3 months
* Non-remission Cancer or in remission for less than 6 months
* Any contraindication to colonoscopy and/or biopsy, left to PI discretion
* Under guardianship or judiciable protection
* Pregnant or breastfeeding women
* Currently participating or having participated in the last 3 months to a clinical study with investigational medicine or food supplement

Specific for Crohn cohort:

* Crohn disease localized only in Ileum
* Inflammatory colon pathology other than Crohn's (infectious, drug-induced,...)
Effect of Modified Dental Visual Aids on Behavior Management During Dental Treatment in Children With Autism Spectrum Disorder

There is a need to find an approach that is appropriate for managing children with Autism Spectrum Disorder in the dental clinic, to manage their behaviour and decrease their anxiety in this research we will apply our modified dental visual aids and test its effectiveness in managing the behavior of such children during the dental appointment.


Eligibility Criteria:
Inclusion Criteria:

* Patient age between 6-10 years.
* Child patient has to represent the typical triad symptoms of ASD that include: social interaction deficits, communication impairment, language impairment and rigidity of interests.
* Child patient with ASD diagnosis confirmed in the patient's files according to "the DSM-V criteria" (American Psychiatric Association, 2013).
* Child patient with mild to moderate ASD according to "the Childhood Autism Rating Scale (CARS)" (Schopler et al., 1998).

Exclusion Criteria:

* Patient age younger than 6 years and older than 10 years.
* Child patient with other congenital anomalies, for example, "Cerebral Palsy" or "Down Syndrome".
* Child patient with previous dental experience.
* Child patient with severe ASD according to "the Childhood Autism Rating Scale (CARS)" (Schopler et al., 1998).
Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery

The aim of the study is to quantify postoperative pain after functional endoscopic sinus surgery (FESS) and investigate whether preemptive analgesia may positively impact intraoperative anesthetic management, decrease patient postoperative pain and discomfort, and improve patient functional outcomes.

The sphenopalatine ganglion block (SPGB) with local anesthetic is used to treat facial pain and headache of various etiologies and has been widely used during functional endoscopic sinus surgery (FESS). The purpose of this study was to investigate whether preemptive SPGB may positively impact postoperative pain and functional outcomes after FESS.

A prospective, double-blind randomized placebo-controlled study was performed. 60 patients (18 to 70 yrs), undergoing general anesthesia for bilateral FESS, were randomly assigned to receive SPGB with either 2 ml 0.25% bupivacaine with epinephrine 1:100,000 (BP, treatment group) or normal saline (NS, control group). SPGB was performed preemptively 10 min before the start of surgery. Pre- and post operative (day#0, day#7, day#30) visual analogue pain scale, SNOT-20, CT \& Endoscopic scores were compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. The study subjects will be 18-70 year old.
2. The subjects will be American Society of Anesthesiology physical status I and II patients.
3. Patients with chronic rhinosinusitis, presenting for bilateral functional endoscopic sinus surgery.
4. The subjects should understand informed consent and study instructions, AND 5. The subjects should not participate in any other research protocols.

Exclusion Criteria:

1. Patients with pre-existing chronic facial pain not related to chronic rhinosinusitis.
2. Patients with pre-existing chronic pain of different etiology.
3. Patients taking prescription pain medications.
4. Patients taking antidepressant medications.
5. Patients taking over-the-counter pain medications within 48 hours of scheduled surgery.
6. Patients in whom oral opioid-containing analgesics would be contraindicated postoperatively.
7. Patients with a known or suspected genetic susceptibility to malignant hyperthermia, or known sensitivity to Desflurane or other halogenated agents.
8. Patients with the history of arrhythmias or significant coronary artery disease.
9. Patients with psychological disorders.
10. Patients who are unable to understand the questionnaires or the visual analogue scale (VAS) pain scores.
11. Patients with the history of substance or alcohol abuse.
12. Patients with compromised renal and liver function.
13. Patients with abnormal coagulation status or platelet count less than 100,000.
14. Pregnant patients.
15. Patients with an allergy to Bupivacaine, Lidocaine or Epinephrine.
16. Other patients that may be excluded by the investigator, based on medical history and physical examination
Virtual Reality-based Therapy and Barriers in Cardiac Patients

The aim of this study is to investigate the chronic hemodynamic and autonomic repercussions of the insertion of VRBT in CR. To qualitatively analyze the perception of patients and physiotherapists regarding the use of VRBT, as well as their association with CR, and through a new questionnaire that takes into account patients 'adherence, identifying which are the main barriers that influence patients' absences.

Introduction: Despite the benefits that cardiovascular rehabilitation programs (CR) can promote, there are problems regarding adherence, which can be related to several factors, among them, motivation. Alternative therapies can reflect on motivation and promote increased adherence to CR. In this context, virtual reality-based therapy (VRBT) appears as an option. Additionally, chronic hemodynamic and autonomic repercussions of VRBT in relation to CV still need to be investigated. Objective: To evaluate the chronic hemodynamic and autonomic repercussions of the insertion of VRBT in CR. To qualitatively analyze the perception of patients and physiotherapists regarding the use of TRV, as well as their association with CR, and through a new questionnaire that takes into account patients 'adherence, identifying which are the main barriers that influence patients' absences. Methods: cardiac patients or individuals with factors that regularly participate in CR will participate in this study. Patients will be randomly allocated to CR + VRBT intervention or keeping the normal routine. Interventions will be carried out three times a week for 12 weeks. The primary outcome will be to assess chronic hemodynamic repercussions (blood pressure, heart rate, respiratory rate, oxygen saturation and perceived exertion using the Borg scale) and autonomic (linear and non-linear data). The secondary outcome consists of a qualitative assessment through a focus group with patients and a focus group with therapists, in addition, the new questionnaire developed to identify the influence of barriers on patients' adherence to CR will be applied.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of cardiovascular disease.
* Clinical diagnosis of cardiovascular risk factors.

Exclusion Criteria:

* Presence exacerbated signs or symptoms.
* Balance problems.
Safety and Tolerability of a Single Intra-anal Dose of NRL001 in Healthy Volunteers

This study is conducted to explore the safety and tolerability and plasma pharmacokinetics of NRL001 after single intra-anal dose of 1mL cream at increasing concentrations.


Eligibility Criteria:
Inclusion Criteria:

IN.1) sex: male and female (non-child-bearing potential or using medically adequate contraception

IN.2) race: Caucasian

IN.3) BW: 50 - 100 kg

IN.4) BMI: 20 - 28 kg.m-2

IN.5) age: 21 - 50 years

IN.6) type: healthy on the basis of specified criteria evaluated at the screening visit

IN.7) willing and able to provide informed consent

Exclusion Criteria:

General

EX.1) Previous participation in the trial

EX.2) Participant in any other trial during the last 90 days

EX.3) Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months

EX.4) History of any clinically relevant allergy (including hypersensitivity to the trial medications)

EX.5) Presence of acute or chronic infection

EX.6) Presence or history of any relevant co-morbidity

EX.7) Resting systolic blood pressure \> 140 or \< 90 mmHg, diastolic blood pressure \> 95 or \< 50 mmHg

EX.8) Clinically relevant ECG-abnormalities, prolonged QTc with \> 450 msec in males and \> 460 msec in females in particular

EX.9) Presence of any relevant abnormality in the laboratory safety tests, especially low haemoglobin, increased liver enzymes

EX.10) Positive serology for HBsAg, anti HBc and anti HCV

EX.11) Positive HIV test

EX.12) Positive alcohol or urine drug test on recruitment (and upon admission)

EX.13) History of alcohol and/or drug abuse and/or daily use of \> 30 gr alcohol

EX.14) Smoking more than 15 cigarettes/day or equivalent of other tobacco products

EX.15) Use of prohibited medication

EX.16) Suspicion or evidence that the subject is not trustworthy and reliable

EX.17) Suspicion or evidence that the subject is not able to make a free consent or to understand the information in this regard

General - all females

EX.18) Positive pregnancy test

EX.19) Lactating

EX.20) Not using appropriate contraception in pre-menopausal women (note: under the conditions of the present study, women using hormonal contraceptives will be informed that this method is not sufficient during the study and that further i.e. mechanical methods \[condom, diaphragm with spermicidal gel\] should be used in addition).
How is Social Connection Represented in the Brain?

Nearly half of the U.S. population sometimes or always experiences loneliness, which is alarming given that loneliness confers risk for negative mental and physical health outcomes. Extensive research suggests loneliness is characterized by subjective isolation: many lonely individuals maintain a number of relationships but still report feeling lonely. The goal of this proposal is to use functional magnetic resonance imaging to reveal how the brain represents our subjective connection to and isolation from other people, which will ultimately inform optimal ways to intervene to reduce loneliness.

Extensive research suggests loneliness is characterized by subjective isolation: many lonely individuals maintain a number of relationships but still report feeling lonely. Thus, a neurobiological account of loneliness requires that we understand how the brain represents subjective connections to others and how loneliness alters these representations. The long-term goal of this proposal is to identify how subjective isolation is represented in the brain in order to identify novel ways to intervene on this representation to attenuate loneliness. This study proposes that the brain organizes representations of people based on subjective connection to them, and that loneliness systematically alters this organization. The Specific Aim 1 will determine whether subjective closeness organizes self and other representations in the brain. While undergoing fMRI, participants will complete tasks in which they reflect on themselves and other people. They will also report on their subjective closeness to the other people. The study will test whether the brain organizes mental representations of the self and one's own social network members based on subjective closeness. The Specific Aim 2 will determine how loneliness modulates self and other representations in the brain. The Specific, Exploratory Aim 3 will determine the cognitive consequences of altered self and other representation in loneliness. The proposal of this study is imperative for ultimately revealing neurocognitive mechanisms to intervene on to reduce loneliness.

Eligibility Criteria:
Inclusion Criteria:

* safe for MRI scanning
* not taking psychiatric medication

Exclusion Criteria:

* not safe for MRI scanning
* taking psychiatric medication
External Pop-out and Classic Fetal Head Extract During Cesarean Section

Cesarean section is the delivery of the fetus through a surgical incision in the abdominal wall (laparotomy) and uterine wall (hysterotomy). The rate of cesarean delivery has increased progressively in the last decades until it becomes the most common operation performed all over the world.

A multitude of efforts had been done aiming at a reduction of cesarean section related maternal morbidities; most of them are related to technical modifications of how to open and how to close the abdominal and uterine incisions. The comparative studies of blunt versus sharp extension of the uterine incision showed a reduction of the incidence of unintended extension from 8.8% to 4.8%.

Delivery of the fetal head through the uterine incision is one of the major technical problems during elective cesarean section, especially when the presenting part is non-engaged. All of the previously described procedures, alternative to the classic manual head extraction, were inconclusive and not convincing to the obstetricians for routine use.

Also, no reported well-designed trials favor one of them over other. Application of vacuum cup, use of forceps blade, increasing fundal pressure and making additional uterine incisions were previously reported as alternative techniques. None of them gain any popularity or proved to be used as a basic step during cesarean section, besides many complications were reported due to their use on mothers and infants.

The vulnerability of the lower uterine segment for tears is related to the stage of labor. The frequency of unintended extension was reported to be 15.5%, and 35.0% in cases operated in first and second stages of labor respectively.

As with any surgical operation, anticipating difficulties during cesarean delivery and avoiding these difficulties is always the greatest practice. Although much has been written about techniques for managing difficult head extraction during vaginal deliveries, the reports addressed the management of difficult head delivery during cesarean section in literature are scarce.

The original techniques of fetal head extraction entail the introduction of the obstetricians hand or other instruments into the lower uterine segment. This puts the lower uterine segment at risk of damage and incision extensions with its consequences of increased blood loss, increased operative time, infection, adhesion and blood transfusion. Adherence to the available the generated good quality evidence bases practice in cesarean section is anticipated to decrease such morbidities.

The idea of the present technique was derived from the fact that during vaginal delivery the main task of the obstetrician is to support the perineum while the fetal head extends to get out through birth canal.


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women in single, living, term (\>37 weeks), cephalic fetus.
2. Women eligible for elective Cesarean section.

Exclusion Criteria:

1. Multiple gestations
2. Placenta previa
3. Fetal congenital anomalies as hydrocephalus
4. Intrauterine fetal death.
5. US evidence anhydramnios
Utilization of Uterine Manipulator in Abdominal Hysterectomy

The investigators aimed to investigate whether the uterine manipulator which is usually utilized in laparoscopic hysterectomy would also be of benefit in preventing postoperative vaginal length and sexual function by facilitating the accurate localization fo the colpotomy site. Patients scheduled for abdominal hysterectomy for benign causes will be randomized into two arms: Group 1 Uterine manipulator arm in which participants received a uterine manipulator during the procedure for aiding to locate the accurate colpotomy site and Group 2 consisting of control patients who will not receive uterine manipulator but undergo a standard abdominal hysterectomy. Postoperative vaginal length, postoperative female sexual function index (FSFI) will be compared with the preoperative measurements in the two groups. A 5 points Surgeon satisfaction scale will also be applied to the surgeons and residents performing the surgery to address their satisfaction in locating the colpotomy site.

The uterine manipulator is a device that facilitates to locate the colpotomy site and visualization of surgical are during laparoscopic hysterectomy. The investigators consider that adoption of the uterine manipulator will also facilitate to locate the colpotomy site in abdominal hysterectomy. Therefore the investigators are planning to enroll patients undergoing an abdominal hysterectomy in this study. Patients will be allocated into one of the study groups: Group 1 Uterine manipulator arm in which participants received a uterine manipulator during the procedure for aiding to locate the accurate colpotomy site and Group 2 consisting of control patients who will not receive uterine manipulator but undergo a standard abdominal hysterectomy. All abdominal hysterectomies will be carried out by the same surgeon under general anesthesia. One week before the surgery vaginal length will be measured and the female sexual function index (FSFI) will be obtained from all patients. Following the surgery vaginal length will again be measured at 3 months and the female sexual function index (FSFI) will be obtained from participants by a research staff who is also a gynecologist. Prevalence of postoperative dyspareunia will be asked to the patients at postoperative 3 months. Just after the surgery, a 5 points surgeons' satisfaction scale will also be completed by the surgeons and residents performing the surgery to address their satisfaction in locating the colpotomy site either with the uterine manipulator as in group 1 or by manually guiding as in group 2.

Eligibility Criteria:
Inclusion Criteria:

- Must be scheduled for total abdominal hysterectomy for benign causes Must be premenopausal Must be sexually active

Exclusion Criteria:

- Apical prolapsus Endometriosis Psychiatric disease
Singing for Wellness: Is Singing a Useful Way of Supporting People in South Devon to Self-manage Aspects of Their COPD

The aim of this study is to explore whether singing is a useful way of supporting people in South Devon to self manage aspects of their COPD and associated social isolation. It will also investigate whether a model of bespoke respiratory community choirs provides a useful service for our local community. The study will look at the impact of singing on breathing, wellbeing, frailty and engagement.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with COPD

  * Evidence of airflow obstruction as measured by spirometry
  * Being independently mobile and able to get to location
  * Being able to give permission to participate
  * Over 18 years old
  * Awaiting pulmonary rehabilitation or have completed pulmonary rehabilitation

Exclusion Criteria:

* Lacking capacity to give permission to participate e.g. severe dementia

  * Other health issues which preclude participation e.g. psychosis, unstable physical health
  * Under 18 years of age
  * Not diagnosed with COPD
The Effects of Low-level Laser Therapy in Extensor Tendon Injuries Between Zones 5-8

This study examines the rehabilitation results when low-level laser therapy is applied in zone 5-8 extensor tendon injuries. Rehabilitation results will be evaluated with both objective measurements and patient reported outcome measures. The study was planned as a double-blind, placebo-controlled, randomized, two-arm study. Participants in both treatment groups will be given exercise therapy in accordance with the early active mobilization protocol and appropriate splint will be given to be used while exercising.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65
* Primary repair due to extensor tendon injury between Zones V-VIII
* Applying to the Hand Rehabilitation Policlinic at the end of the postoperative 1st week

Exclusion Criteria:

* Accompanying flexor tendon injury, fracture, vascular and / or nerve injury
* Active using of steroids or non-steroidal anti-inflammatory drugs
* Systemic infection or malignancy
* Pregnant or breastfeeding women
* Active wound infection
* Having a cognitive dysfunction