cyrilzakka/clinical-trials huggingface dataset:
Computerised Behavioural Activation for Young People With Depression

The primary aim of this non-randomised feasibility study is to 1) examine the acceptability of a newly developed computerised Behavioural Activation programme (BALM) in treating young people experiencing low mood/depression and 2) assess the feasibility of undertaking a pilot Randomised Controlled Trial (RCT) of the intervention.

Approximately 20% of adolescents will have had at least one depressive episode by the age of 18 making depression one of the leading causes of illness and disability in young people. Although receiving effective treatment is important, as few as 35% of young people seek help, with treatment-related issues (e.g. stigma, negative attitudes about help-seeking, accessibility, reluctance to engage one-to-one with a therapist, etc) outlined as reasons for this. Computerised therapies, which have increased availability and accessibility, reduced stigma and can be delivered in a format attractive to many young people may avoid some of these barriers and provide a more effective treatment option for young people.

Behavioural Activation (BA) - a type of talking therapy focused on increasing liked activities has demonstrated effectiveness in treating depression in adults and, owing to this, is an evidence-based treatment for depression within NICE (2009) guidelines. Despite this, less research has examined its use with young people.

We have developed BALM (Behavioural Activation for Low Mood), an online BA programme designed for use with young people experiencing mild to moderate low mood or depression. The development of BALM was based upon the findings of a systematic review and a series of qualitative interviews and focus groups with young people and healthcare professionals.

Eligible young people will be referred to the programme via healthcare professionals working in local Child and Adolescent Mental Health Services and mental health practitioners based in local secondary schools.

The findings of this research will allow us to refine the intervention and the research methods we employ in preparation for a pilot randomised controlled trial (RCT) of the new treatment.

Eligibility Criteria:
Inclusion Criteria:

* Aged 11 to 16 years at the date of consent
* Experiencing low mood or depression symptoms as defined by a score of ≥20 on the Mood and Feelings Questionnaire
* In agreement that their primary care provider and a parent/guardian can be informed of any concerns the lead researcher has about their wellbeing during participation

Exclusion Criteria:

* Within the normal range on the measure of depressive symptoms (i.e. attaining a score of ≤19 on the Mood and Feelings Questionnaire)
* Experiencing severe low mood or depression symptoms
* Having a comorbid mental health diagnosis of Bipolar Disorder or Psychosis.
* Non-English speaking (due to the small scope of this study, the option of providing translated versions of BALM and the outcome measures was not feasible)
* Deemed to be actively at risk of self harm or suicide
* Have no access to the internet and therefore no programme access
Visual Perceptual Learning for the Treatment of Visual Field Defect

This study will test the hypothesis whether visual field defect caused by chronic stroke could be improved by visual perceptual learning. The secondary hypothesis is that improvement of visual field defect would be accompanied by connectivity changes in visual networks. In addition, investigators will evaluate whether improvement of visual field defect could achieve improvement of subjective visual function.

Study design: A PROBE (Prospective, Randomized, Open-label, Blinded-endpoint) design

Methods:

1. Visual perceptual learning (VPL) group

   1. Visual perceptual learning (24 times for 2 months, 3 times per week) in visual field defect areas
   2. At baseline and post-VPL evaluations (2 months after): Structural \& Functional MRIs, Visual field tests, Visual evoked potential, Visual cognitive tests, Subjective visual function questionnaires
2. Control group

   1. At baseline and 2-months later: No VPL, Structural \& Functional MRIs, Visual field tests, Visual evoked potential, Visual cognitive tests, Subjective visual function questionnaires
   2. Visual perceptual learning after 2-month follow-up evaluation (24 times for 2 months, 3 times per week)

   (The patients who were stratified by age (over 65 years old or not) and degree of visual field defect (quadrantanopia or complete hemianopia) will be randomly assigned into the learning and control group.)
3. Investigations

   1. Improvement of visual field test scores between VPL group and control group
   2. Analysis of brain network changes in MRI data
   3. Correlation analysis of improvement of visual field defect and MRI data
   4. Correlation analysis of improvement of visual field defect and visual evoked potential (VEP) data
   5. Correlation analysis of improvement of visual field defect and neuropsychological data

Eligibility Criteria:
Inclusion Criteria:

1. The patient has chronic stroke more than 6 months after onset.
2. The patient has visual field defect (Quadrantanopia or Hemianopia).
3. The patient has corrected eyesight 0.7 or above.

Exclusion Criteria:

1. The patient has contraindication to MRI scan.
2. The patient has cognitive impairment (Mini-Mental Status Exam score \<24).
3. The patient has ophthalmologic diseases (e.g., glaucoma, cataract).
Long-term Follow-up of Anterior Cruciate Ligament Injury

Anterior cruciate ligament (ACL) rupture is one of the most common sports-related knee injuries. Because it is such a significant injury - requiring a long period of rehabilitation before the injured person is ready to return to physical activity, the burden of injury is high. This can help to explain why so much of orthopaedic research is devoted to evaluating the outcomes of ACL injury. However, while there has been extensive study of short-term (up to 5 years after injury) outcomes, few studies have followed patients beyond 15 years after their ACL injury. This is important because long-term follow-up can provide key insights to guide the information provided to newly injured patients (e.g. to help set realistic expectations of what the injured person can expect of their knee function in the future), and help us evaluate the efficacy of previous treatments.

The primary aim is to assess the influence of an acute ACL injury on knee function and quality of life, 32-37 years after the index injury. Approximately 300 patients injured between 1980 and 1985 will be invited to participate in the study. Patient- and clinician-reported outcomes, and radiographic osteoarthritis will be evaluated.

Patients injuring their ACL between 1980 and 1985 have periodically been followed since the injury. Now, we plan to contact all patients and invite them to participate. The patients will be asked to

1. complete a questionnaire battery
2. visit the movement laboratory at Linköping University for an objective assessment of knee function and
3. have an x-ray of both knee joints.

Baseline information including associated injuries, treatment and activity level exist for all the patients. At that time, rehabilitation was normally completed after 4-6 months for non-operatively treated patients, and nine months after ACL surgery.

Eligibility Criteria:
Inclusion Criteria:

* primary ACL injury between 1980 and 1985, age between 15 and 40 at injury

Exclusion Criteria:

* all patients from the initial cohort will be invited for participation
The Effects of Trout Fed With a Vegetable Based Feed on Cardiovascular Risk Markers and Plasma Proteome

Fish from the aquaculture sector constitutes an increasing part of the fish consumption in Denmark. The most important farmed fish in Denmark is the rainbow trout. Due to limited access of wild fish for the feed production, alternative feeding regimes of vegetable origin such as vegetable proteins and rapeseed oil are used instead of marine feed. This change in feeding regime may affect flesh quality and health and nutritional properties as the content of long-chain n-3 polyunsaturated fatty acids (n-3 LCPUFA) will presumably decrease in the meat. The objective of the study is to investigate the effect of vegetable based feed versus marine feed of farmed trout and its effect in healthy men on cardiovascular risk markers associated with the development of cardiovascular disease (CVD).

In a two month parallel study including 60 healthy men aged 40-70 years, the cardiovascular effect of one daily meal of trout fed with a vegetable based feed are compared with that of trout fed with marine feed (estimated intake of n-3 LCPUFA 2.6 g/day) and a standard Danish diet with poultry. Men are randomised to one of the three groups. Red blood cell fatty acid composition, classical cardiovascular disease (CVD)-risk markers (blood pressure and plasma lipid profile), newer CVD-markers (arterial compliance and plasma markers of endothelial function and inflammation) and plasma proteome analysis are measured at the beginning and end of the intervention period.

Eligibility Criteria:
Inclusion Criteria:

* Age 40-70
* Body mass index 18,5 - 30

Exclusion Criteria:

* Exercise \>10 h/week
* Chronical diseases (eg. cardiovascular and diabetes)
* Regular medication
* Fish oil supplementation
* Blood donation 2 month prior or during participation
* Above maximum recommended alcohol intake
* Blood pressure \>160/100 mm Hg
Clinical Research on Bowel Symptoms of Patient With Pelvic Organ Prolapse

To study the prevalence of bowel symptoms in patients with pelvic organ prolapse.


Eligibility Criteria:
Inclusion Criteria:

* The patients with stage\>2 POP are recruited.The patients are all received surgeries, which include transvaginal synthetic mesh surgery, the sacral fixation, tissue repair surgery and colpocleisis.

Exclusion Criteria:

* Gestation；
* Inflammatory bowel disease；
* Slow transit constipation diagnosed by Colonic transit test；
* Unable to follow up.
Diabetes Prevention With Lifestyle Intervention and Metformin Escalation

Specific Aim: Implement an evidence-based diabetes prevention pragmatic trial for high risk pre-diabetic individuals of Caribbean-descent to reduce the incidence of diabetes.

Hypothesis: This study seeks to test the hypothesis that implementation of a lifestyle intervention, with escalation to Metformin therapy will lower the incidence of diabetes among the highest risk pre-diabetic individuals of Caribbean-descent.

The investigators propose to conduct a pragmatic trial that tests the effectiveness of lifestyle modification and Metformin use in minority populations. Our study population is Caribbean-descent individuals in Region 2, Trinidad and Barbados. The investigators will have five clinical intervention sites situated in New York - 2, Puerto Rico -1, Barbados -1, Trinidad -1 and US Virgin Islands -1. These sites were chosen because of the investigators' strong research network in these locations, and to enable us to address diabetes disparities due to geographic differences. The investigators will first modify an established lifestyle modification workshop series developed by the East Harlem Partnership for Diabetes Prevention (EHPDP) for use in the community, 10to target the population at the involved clinical sites. The investigators plan to adapt the D-CLIP protocol and escalate to Metformin therapy for the highest risk pre-diabetic patients whose hemoglobin A1c (HbA1c) has not improved or who remain morbidly obese.

The investigators will leverage our existing robust research infrastructure and network at the five sites through our Eastern Caribbean Health Outcomes Research Network (ECHORN) and now the Yale Transdisciplinary Collaborative center for Health Disparities focused on Precision Medicine (Yale-TCC). ECHORN is a research collaboration funded by the NIMHD (U2458849938) to address the burden of chronic disease in USVI, PR and the Eastern Caribbean. The Yale-TCC (U54MD010711) leverages the infrastructure and knowledge of the ECHORN, expands to include New York and New Jersey and focuses on diabetes and hypertension. The investigators' network includes community advisory boards as well as policy delegations that are well suited to inform this project and its expansion into routine healthcare practice and policy.

The control arm of this study was never activated due to COVID-19 restrictions.

Eligibility Criteria:
Inclusion Criteria:

* BMI\>25 or WC\>88/102cm
* No history of type I or type II diabetes or gestational diabetes
* Not on blood sugar altering medication
* Ability to attend weekly sessions
* HbA1c 6-6.4%

Exclusion Criteria:

* Pregnant
* eGFR\<45 mL/min/1.73 m2
* Prescribed Metformin and randomized to the control arm
Testing the Efficacy of an Online Alcohol Intervention in a Workplace Setting

The purpose of this study is to test - in a workplace setting - if an online multi-session alcohol intervention improves treatment effect over and above a single session screening with feedback.

Hypothesis: automated online multi-session follow-up improves the effect on alcohol consumption over and above a single session screening

Setting: Online study among Norwegian employees.

Participants: At-risk drinkers among employees in a select group of norwegian workplaces is recruited through an e-mail to their job e-mail account, and advertisements on the intranet of their organization.

Design: Randomized controlled trial (RCT). Subjects in both conditions receives a single session screening procedure including individualized normative feedback. The control group receives an online booklet about the effects of alcohol. The treatment group receives the multi session follow up program "Balance".

Eligibility Criteria:
Inclusion Criteria:

* hazardous or harmful drinking (i.e., a FAST-score of 3 or more)

Exclusion Criteria:

* underage (\<18)
* not provided a valid e-mail address
* not provided a valid (Norwegian) mobile phone number
Does Low Dose of Dexamethasone Enhance Analgesic Quality of Caudal Analgesia in Children Undergoing Orchiopexy?

Caudal block is one of the most effective modalities to reduce pain both during and after the surgery involving areas under the umbilicus. According to previous research, 0.5mg/kg-1.5mg/kg dexamethasone is known to enhance the analgesic quality of caudal block in children. Despite the fact that this high dose of dexamethasone is used to treat airway edema in actual practice and no adverse side effect related to dosage has been reported, it is 3 to 15 times higher than the daily antiemetic dose of dexamethasone that is used in standard care of anesthesia. Therefore, our study aims to assess the effect of the more practical, antiemetic dose of dexamethasone (0.15mg/kg) as an adjuvant to enhance the quality of caudal block through a non-inferiority trial.


Eligibility Criteria:
Inclusion Criteria:

1. Ages from 6 months old to 6 years old
2. Body weight Less than or equal to 16.7kg
3. American Society of Anesthesiologists (ASA) classification I or II
4. Patients receiving orchiopexy under general anesthesia

Exclusion Criteria:

1. Patients with uncorrected cardiac anomalies
2. Patients with vertebral anomalies
3. Diagnosis of diabetes mellitus
4. Diagnosis of adrenal disease
5. Currently on steroid
6. Body temperature above 37.5'C preoperatively
7. Allergy to dexamethasone
8. Laparoscopic surgery
Early Intervention AND NURSING Support for an " Involuntary Commitment Procedure " for a Close Relative

In a context of first hospitalization under the constraint of a relative in psychiatric emergencies:

* effect of an early intervention and a 6-month nursing follow-up on the anxious experience of third party persons
* effect of nursing support on family dynamics, on the durability of outpatient care and adherence

The patient that is meeting during time travel at Psychiatric Emergency come with their families wich live (or have been lived) the crisis at home, in the street, with their family doctor. With a psychic incoming sufferance, when the patient refuses his medicines, doctors ask to someone close to the patient to become his Third party, his first guarantor of the without consent care commitment. These without consent hospitalizations at Toulouse University Hospital, and all over France hospitals, rise continuously. Our daily nursing exercise is to support those helping people. The sentiment felt by our nursing team during the exchange, underlines ambivalence and several emotional problems and difficulties, which are even harder for a first time occurence.

Patient's close relatives that become a " resource " during non-consensual hospitalization could be affected indirectly by the burden of this referent role. Between culpability, isolation and exhaustion, the studies show that their ability to " resist " is a real help for patient progression. This statement is showed by nursing team (even belonging to others structures) listened during our exploratory investigation.In our professional practice, our specific emergency environment is firstly focused about patient in crisis situation and about his security. In this environment, there is no formerly dedicated time for relatives needing, once actors and public in this acute disease. Relatives hard experiences in a very central moment that we could consider as care beginnings, should impact therapy and patient health care plan. An early, well defined nursing act, built on close relatives needs and expectations could enhance this particular moment that should facilitate the following of the patient disease. A lot of data cited in literature specify the central role of relatives for a psychic patient, but there is no study about an early nursing intervention for Relatives during a psychiatric emergency.

Eligibility Criteria:
Inclusion Criteria:

* Being the "Third Party" adult, during the first involuntary commitment procedure of a close relative, in an ASPDT(u) form.
* Being physically present during the admission, within 24 hours after the arrival of the patient.
* Accept to be recontacted by phone to J7, M2, M4 and M6
* Affiliated person or beneficiary of a social security scheme.
* Free and informed consent, signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).

Exclusion Criteria:

* To be the guardian or any person in charge of legal representation with the patient.
* Pregnant or lactating woman (the duration of the study may affect the subject's compliance and availability).
Comparison of Infant Pain Responses Between Two Different Methods of Urine Collection

The purpose of this study is to determine which of the two procedures commonly used to collect urine, percutaneous suprapubic aspiration (SPA) and urethral catheterization (UC), is less painful, and the success rates and complication rates associated with both methods.

Infants hospitalized in the NICU undergo numerous invasive and painful procedures. Exposure to early repeated painful procedures has been correlated with both short-term and long-term negative sequelae, such as altered pain responses and increased sensitivity to pain (Taddio 2005). Fifty eligible infants in the NICU will be randomized to undergo urine collection by either suprapubic aspiration (SPA) or urinary catheterization (UC). Outcome measures will include pain, procedure success, and procedure duration. Pain will be measured using facial grimacing (the infant's face will be videotaped for the entire procedure), heart rate and oxygen saturation. Procedure success will be defined by the collection of about 2mL of urine (Falcao, 1999). The procedure duration in seconds for the first attempt will be calculated. Infants will be monitored during the procedure for adverse events such as apnea, bradycardia, desaturation, emesis, increased ventilatory support. Results will be extremely valuable in aiding health care providers to choose a urine collection technique that minimizes the pain and maximizes the success of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Infants in the Neonatal Intensive Care Unit (NICU) who require urine samples for microbiological analysis

Exclusion Criteria:

* Clinical diagnosis of birth asphyxia or seizures
* Neurological conditions
* Congenital anomalies associated with the central nervous system, gut, or genitourinary tract
* Abdominal distension or abdominal infection/cellulitis
* Colostomy
* Inguinal hernia
* Organomegaly
* Bleeding diatheses (thrombocytopenia or coagulopathy)
* Receiving analgesics or sedatives
Desflurane Versus Propofol Anesthesia for Off-Pump CABG

The purpose of this study is to prove if anesthesia maintained with the inhaled volatile anesthetic desflurane is superior to the intravenously applied propofol anesthesia in off-pump coronary artery bypass grafting (OP-CABG) surgery as measured by following parameters:

1. hemodynamic parameters during and after the operation,
2. pulmonary gas exchange, need for mechanical ventilation and for ICU and intrahospital stay,
3. release of heart muscle injury markers in response to surgery and intraoperative ischaemia,
4. inflammatory response to the operation.

We suspect that insufflation anesthesia with desflurane may be superior to intravenous anesthesia with propofol.

General anesthesia will be induced by intravenous dosis of fentanyl, vecuronium and etomidate and further maintained either by inhaled desflurane or propofol infusion, with concomitant empirically administered fentanyl doses and continuous infusion of vecuronium.

After induction of anesthesia a Swan-Ganz catheter for continuous cardiac output, right ventricle end diastolic volume and blood saturation measurements will be introduced through the internal jugular vein. A transesophageal echocardiography probe will be placed additionally for the Tei-index measurement.

Hemodynamic parameters will be recorded at the following time points:

* before induction
* after induction
* during trachea intubation
* before skin incision
* 3 Min. after skin incision
* after sternotomy
* before heart positioning for graft placing
* before finishing placing each distal anastomoses
* 10, 20, 30, 40 min after placing the last anastomoses
* 10 Min. after admission to ICU, 6, 12, 18 and 24 hours after surgery.
* TEE measurements will be obtained after sternotomy and 20 Min after placing the last distal anastomoses.

The results will be compared while using the parametric ANOVA test for normally distributed continuous data or the nonparametric Kruskal-Wallis/Wilcoxon-U test for categoric or inhomogeneous distributed continuous data.

Eligibility Criteria:
Inclusion Criteria:

* Patients with coronary artery disease qualified for CABG off-pump surgery
* Elective surgery
* Signed informed consent

Exclusion Criteria:

* Left ventricle ejection fraction \< 30%
* Serum creatinine \> 2 mg/dL
* Emergency surgery
* Denied consent
BG9924 in Combination With Methotrexate Extension of Study 104RA203 (NCT 00458861)

This study is to observe the long-term treatment of BG9924

Extension study for 104RA203 (NCT 00458861)

Eligibility Criteria:
Inclusion Criteria:

* Must be a participant from Study 104RA203 (NCT 00458861)

Exclusion Criteria:

* Participants with a significant change in medical history from their previous BG9924 Study 104RA203 (NCT 00458861).
* Nursing mothers, pregnant women, or women who are planning to become pregnant while in the study.
* Male and female participants of child-bearing potential not willing to practice effective birth control for the duration of the study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.