cyrilzakka/clinical-trials huggingface dataset:
Modified LPB and SPB vs Classical LPB and SPB

The timing of surgery for hip fractures is crucial for elderly patients. The mortality rate for elderly patients after hip fracture is high, and anesthetic decisions significantly affect the patient's outcome. Regional anesthesia has been shown to have better outcomes than general anesthesia. We proposed a newly developed modified position for the ultrasound-guided combined anterior lumbar and lateral sacral plexus block technique that offers benefits, including minimizing interference with circulation and anesthesia, avoiding position change and pain, and providing effective postoperative analgesia.

The increasing proportion of elderly patients requiring surgery, particularly for hip fractures, is common among the elderly. The timing of surgery for hip fractures is crucial and most require surgical treatment. The mortality rate for elderly patients after hip fracture is high, and anesthetic decisions significantly affect the patient's outcome. Elderly patients have decreased physiological function and are more susceptible to postoperative complications, such as delirium, constipation, pressure sores, and catheter-related infections. Regional anesthesia has been shown to have better outcomes than general anesthesia. We proposed a newly developed modified position for the ultrasound-guided combined anterior lumbar and lateral sacral plexus block that offers benefits, including minimizing interference with circulation and anesthesia, avoiding position change and pain, and providing effective postoperative analgesia. The study validates the feasibility and effectiveness of this technique for elderly hip fracture surgery and compares it with a traditional lumbar-sacral plexus nerve block, providing a fresh perspective on anesthesia for this type of surgery.

Eligibility Criteria:
Inclusion Criteria:

Patients over 70 years of age. ASA classification grades II-IV. Patients with hip fractures requiring surgery (intramedullary nailing of intertrochanteric fractures).

Exclusion Criteria:

Peripheral neuropathy or other neurological disorders affecting the nerves involved in the block; Serve coagulopathy or platelet dysfunction; Inability to perform puncture due to infection, wound, or other reasons at the puncture site; Allergy to local anesthetics or any other medications used in the block; Inability to cooperate or communicate with the healthcare provider during the procedure; Patients or their families who cannot understand the conditions and objectives of the study.
A Study to Compare Taspoglutide and Insulin Glargine in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Sulfonylurea Combination Therapy

This randomized, open-label, parallel arm study will compare the safety, tolerability and effect on glycemic control of taspoglutide versus insulin glargine in insulin-naïve patients with type 2 diabetes mellitus inadequately controlled on merformin and sulfonylurea combination therapy. Patients will be randomized to receive either taspoglutide 10mg subcutaneously (sc) weekly, or taspoglutide 10mg sc weekly for 4 weeks followed by 20mg sc weekly, or insulin glargine at an initial dose of 10 international units sc daily. Metformin treatment will be continued in all patients throughout the study, whereas sulfonylurea will be discontinued before starting study treatment. Anticipated time on study treatment is 24 weeks, with an option to continue the assigned treatment for another 28 weeks. Target sample size is 500-600 patients.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years of age
* type 2 diabetes mellitus, treated with stable dose of metformin and sulfonylurea for \>/= 12 weeks prior to screening
* HbA1c 7-10% at screening
* body weight stable (+/-5%) for \>/= 12 weeks prior to screening
* fasting C-peptide \>/=1ng/ml
* treatment-naïve for insulin

Exclusion Criteria:

* diagnosis or history of type 1 diabetes mellitus or secondary forms of diabetes
* acute metabolic diabetic complications or evidence of clinically significant diabetic complications
* clinically symptomatic gastrointestinal disease
* history of chronic pancreatitis or acute idiopathic pancreatitis
* \>3 episodes of severe hypoglycemia within 6 months prior to screening
* miocardial infarcion, unstable angina pectoris, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within 6 months prior to screening
* any treatment with exenatide, exendin analogues, GLP-1 or its analogues
Investigation of the Effects of Robot Assisted Gait Training With Virtual Reality on Cognitive Functions in Stroke Patients

It was planned to examine the effects of robot-assisted walking training supported by virtual reality on cognitive functions, quality of life and activities of daily living in individuals with subacute stroke. In this context, only conventional physiotherapy was applied to one group, while the other group was given exercises with Lokomat in addition to conventional physiotherapy.

According to the definition of the World Health Organization, stroke is a clinical syndrome characterized by the rapid establishment of signs and symptoms of focal loss of cerebral function for no apparent reason other than vascular causes. Symptoms last longer than twenty-four hours or may result in death. Stroke is the second leading cause of death in the world and the first cause of disability and loss of work force. Many stroke survivors are dependent on someone else for some part of their daily lives, have limitations in their daily and social activities, and have significantly lost their quality of life. Cognitive disorders after stroke are manifested by difficulties in information processing due to brain damage. The most common cognitive effects in stroke; attention, memory, orientation, executive dysfunction and aphasia.

For cognitive rehabilitation it is known that Lokomat combined virtual reality applications is more effective than Lokomat exercises without virtual reality in individuals with chronic stroke. Our research aims to contribute to the literature by revealing the cognitive functions, ADL and quality of life of locomotive exercises together with virtual reality in individuals with subacute stroke.

Our research will be carried out in the Robotic Rehabilitation Laboratory of Physical Therapy and Rehabilitation Hospital in Ankara City Hospital. The population of the study is the stroke clinics of the same hospital. Individuals with subacute stroke who volunteered to participate in the study will be included in the study. All patients will receive conventional physiotherapy five days a week for six weeks, and the study group will receive with Lokomat three times a week in addition to conventional physiotherapy. The patients will be evaluated by a therapist other than the practitioner before and after the treatment in two groups, one of which is the study group and the other is the control group.

Eligibility Criteria:
Inclusion Criteria:

* First Stroke
* Subacut stroke (from 21 days to 180 days)
* Can do Lokomat exercises

Exclusion Criteria:

* incompatibility to lokomat (Femur lenght problems, severe cognitive impairment, excess weight etc.)
New-onset Severe Headache After Covid-19 Vaccine

Hypotheses:

1. Severe new-onset headache after Covid-19 vaccine occur in a minor subset of vaccinated individuals.
2. Immunological reactivity with activation of trigeminal nociceptors can be among the mechanisms in severe headaches after Covid-19 vaccines.
3. Biomarkers in blood and CSF and imaging findings can be used to assess severe new-onset headache after Covid-19 vaccines.

The main aim of the project is to describe the characteristics of severe new-onset headache after Covid vaccine and the treatment effects.

Secondary aim:

1. Investigate potential mechanisms and analyse biomarkers to predict treatment effects.
2. To assess at baseline and 6-month follow-up the rate of brain MRI pathology.
3. To assess the change xof brain 18F-FDG PET metabolism from baseline and 6-month follow-up
4. To assess the levels of brain specific biomarkers
5. To assess the level of blood specific biomarkers

Duration of Study participation:

* Enrollment: 24 months
* Follow-up: at 3 and 6 months after inclusion. For those with continued severe headache regular 3-month controls are planned during the study.

Total study duration 24 months

Study Design: Prospective observational multi-center study

Cohort study of patients with new-onset severe headache after Covid-19 vaccine. Patients referred to the participating headache clinics for severe headache after Covid vaccine will be invited to participate in the study. The invitation will be given in conjunction with their visit to the headache specialist. Patients already diagnosed and treated for severe headache after Covid vaccine will be invited to participate during control visits at the participating centres. After written informed consent information information from the initial phases will be collected retrospectively from the medical records of the patients that have already been diagnosed and started with treatment. Further information will be collected prospectively. For newly diagnosed patients all information will be collected prospectively. Blood samples will be drawn to assess immunological mechanisms.

Inclusion criteria:

* Patients aged ≥ 18 years with new onset severe headache or severe worsening of pre-existing headache within one week after Covid vaccination and has not resolved within 3 weeks.
* Inclusion within 12 months after symptom onset.
* Informed written consent signed by the patient.

Exclusion criteria:

• Patients not available for follow-up assessments (e.g. non-resident).

Eligibility Criteria:
IInclusion criteria:

* Patients aged ≥ 18 years with new onset severe headache or severe worsening of pre-existing headache within one week after Covid vaccination and has not resolved within 3 weeks.
* Inclusion within 12 months after symptom onset.
* Informed written consent signed by the patient.

Exclusion criteria:

• Patients not available for follow-up assessments (e.g. non-resident).
Guidance in Diet and Physical Activity for Prevention of Weight Gain After Gastric Bypass Surgery

Primary Outcomes:

1. To study cross-sectional associations between diet, physical activity, T2DM and weight in subjects 2 yrs after surgery.
2. To study if subjects receiving extra guidance in diet and physical activity experience less weight gain compared to a control group.

   Secondary Outcomes:
3. To study the association between vit.D levels and T2DM.
4. To study the association between weight change and QOL.
5. To validate the new guidance strategy by recording food intake, energy expenditure and physical activity level.
6. To study if subjects receiving extra guidance in diet and physical activity experience other health effects compared to a control group.
7. To search for biomarkers that can identify people at risk of increasing weight post surgery

Expected weight loss after GBP is 60-80% of the overweight. GBP is effective therapy against the obesity-related disorders, including T2DM. Some subjects start gaining weight within 12-18 months after surgery. Weight gain may again increase the risk for developing obesity-related disorders. Previous studies have found a link between vitamin D deficiencies and T2DM. Vitamin D levels will be monitored during the intervention. Studies have shown that patients who underwent GBP experienced a dramatic improvement in quality of life(QOL). After reaching maximum weight loss, many will slowly gain weight. For some people that means a decrease in QOL. In order to prevent weight gain it may be useful to provide additional follow-ups. Participants are randomised into two groups: Group A will receive extra guidance and follow-up, while Group B will continue with the existing scheme. Participants in Group A will over the next 2 yrs take part in frequent meetings. To assess dietary habits, physical activity patterns and QOL, food diaries, physical activity questionnaires and QOL questionnaires are used. Anthropometric and blood pressure measurements will be taken and blood samples will be collected at regular time intervals before and during the study. The results will be used to validate the effect of extra guidance, and to decide if this treatment shall be offered to all of our patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing gastric bypass surgery at OUH in the period January 2006 to June 2009 (recruited 24 ± 9 months following surgery)
* Willingness to participate at regular meetings at OUH

Exclusion Criteria:

* Patients who have experienced serious complications due to the bariatric surgery
* Patients who do not understand Norwegian
* Immobile patients
Virtual Reality Hypnosis and Nurses' Stress

The practice of nursing is based on helping relationships and empathy. The work is physically, mentally and emotionally demanding. This requires the mobilization of personal resources (lifestyle, coping strategies) and work resources (managerial, medical support, recognition) to cope with stress. When these resources are present, nurses can activate a resilience process through coping strategies. However, stress levels and emotional impact are such that they can lead to states of suffering and trauma such as compassion fatigue (CF). The prevalence of CF is high in the nursing profession and particularly among neonatal intensive care (NICU) nurses.

Several levels of intervention exist to prevent CF in services: organizational, inter-individual and individual. At the individual level, certain interventions such as meditation have been studied, showing positive effects with the highest levels of evidence.

On the other hand, interventions such as hypnosis have not yet been studied in this context. There is, however, an interest in studying hypnosis as a non-pharmacological intervention to reduce stress and improve emotional regulation. Indeed, the hypnotic process (promoting attentional and cognitive rest, redirecting attentional focus, reducing mental effort) is a resource activator. In order to combine individual and organizational support, the intervention must be offered in the workplace and during working hours, given the difficulty nurses have in extracting themselves from the service, the restricted break time and the acceptability of the virtual reality system. In a context where break time is short and precious, it is necessary to use a tool that adapts to these constraints. Virtual reality with the HypnoVR® tool meets these needs. This device acts as a restorative environment. It has already proven its effectiveness in the care of painful and stressed patients in critical situations. It has not yet been studied in the context of work-related stress in healthcare professionals, such as neonatal intensive care nurses. The protocol takes into account the results of studies reporting the effects associated with the use of virtual reality (VR).


Eligibility Criteria:
Inclusion Criteria:

* Nurse
* Regularly work in a neonatal intensive care unit
* Be of legal age and not opposed to participating in research
* Fluency in French

Exclusion Criteria:

* Age \< 18
* Refusal to participate
* Current anticonvulsant or psychotropic treatment
Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus

The purpose of this study is to determine the association between acid reflux and cell changes in Barrett's esophagus.

Specific aim 1: To test the hypothesis that controlled acid reflux is associated with lesser degree of stromal activation.

Specific aim 2: To test the hypothesis that stromal fibroblast derived growth factors drive BE epithelial proliferation.


Eligibility Criteria:
Inclusion Criteria:

1. Prior histological demonstration of Barrett's esophagus that is endoscopically visible; length of visible segment \>/= 1 cm
2. Absence of dysplasia or LGD on biopsies within the past 5 years
3. Ability to provide informed consent
4. Age between 18 years and 90 years at study entry.

Exclusion criteria:

1. Eastern Cooperative Oncology Group performance status 3 or 4
2. Inability to tolerate endoscopic procedures
3. Pregnancy: Females of child-bearing age will be screened with pregnancy test.
4. Prior esophageal surgery, or cancer
Effects of Asymmetries on Binaural-Hearing Abilities Across the Lifespan

Binaural hearing involves combining auditory information across the ears. With binaural hearing, listeners benefit from perceiving sounds from different spatial locations. This is critical in solving the "cocktail party problem" (i.e., understanding speech in the presence of competing background sounds and noise). As humans get older, hearing loss increases, binaural abilities decrease, and the cocktail party problem becomes increasingly difficult. This research studies the mechanisms underlying the impact of age and hearing loss on speech-perception in noise and cocktail-party listening situations. More specifically, the role of hearing asymmetries between the ears is investigated. The specific aims are to generate an audiological and binaural-hearing-focused dataset for a large cohort of participants that vary in hearing asymmetry, age, and hearing loss and to use machine learning to uncover complex associations and generate novel hypotheses relating audiometric variables and basic binaural-hearing abilities to the cocktail-party problem. Participants in this research will complete perceptual measures of hearing acuity and spatial hearing. Participants will also report on speech understanding under noisy and challenging listening conditions. This research may lead to improvements in audiological care and hearing interventions.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18-80 years)
* No hearing asymmetry between ears (≤10 dB at any frequency) or, hearing asymmetry between ears \>10 dB
* Native English speakers
* Primarily use oral language
* Sufficient corrected or uncorrected visual acuity (20/50 or better) to read large-font text

Exclusion Criteria:

* Acoustic tone-detection threshold \>50 dB HL at any octave frequency (250-4000 Hz) in either ear (i.e., more than a moderate hearing loss)
* History of neurological disorders (e.g., stroke, Parkinson's disease) determined by self-report
* History of post-traumatic stress disorder or traumatic brain injury determined by self-report
* Possibility of acoustic neuroma, hearing asymmetry (\>10 dB at three consecutive audiometric threshold frequencies)
* Montreal Cognitive Assessment (MoCA) score \<22/30
* No oral language use
* Cochlear implant user
* Conductive hearing loss
Quality of Life in Patients With Auto-inflammatory Diseases

This qualitative interview-based study aim to build a tool to assess quality of life in patients (adults or children) suffering from 6 autoinflammatory diseases (FMF, TRAPS, CAPS, MKD, Still and PFAPA).

Recent understanding of the physiopathological mechanisms that underpin autoinflammatory diseases (AIDs) allowed a revolution in the therapeutic management of these patients, particularly through the use of biotherapies. However new treatments need to be evaluated by valid tools. AIDAI score created and validated by our team evaluates activity of 4 autoinflammatory diseases. One of the important components, not explored by the scores currently available, is the impact of these treatments on quality of life (QoL) of patients. The existing quality of life scales are not adapted to these recurrent chronic pathologies. Throught a qualitative study based on interviews of patients and/ or parents, the investigators aim to build a tool to evaluate QoL in patients suffering from 6 aAIDs :familial Mediterranean fever (FMF), mevalonate kinase deficiency (MKD), tumour necrosis factor receptor-associated periodic syndrome (TRAPS), cryopyrin-associated periodic syndromes (CAPS), Still's disease and PFAPA syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Any patient (child and adult) with one of the 6 AIDs (FMF, TRAPS, MKD or CAPS, PFAPA or Still's disease) regardless of the activity of the disease. The diagnosis will have been made by the referring physician according to criteria specific to each AIDs
* Volunteer to participate in the study
* With at least one parent present at the consultation if it is a child under 18 years old
* For minors, agreement of the parents or their legal representative or one of the present parents
* Information for children as far as their age and condition allow
* Affiliation to a national health insurance.

Exclusion Criteria:

* patient or relative (according to age)refuse to participate.
* Bad understanding of French.
* Other chronic inflammatory pathology associated (example: Crohn's, SPA, uveitis, psoriasis ...)
ALF-ONE : ALFuzosin ONcE Daily

The aim of the study is to collect, under daily practice conditions, clinical data on the safety profile and the efficacy of a new formulation of alfuzosin administered once daily in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH).


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory patients suffering from Lower Urinary Tract Symptoms suggestive of Benign Prostatic Hyperplasia

Exclusion Criteria:

* Patients requiring Benign Prostatic Hyperplasia surgery immediately or within the 12 following months
* Patients previously not improved by an alpha 1-blocker treatment
* Patients whose urinary symptoms are satisfactorily controlled on other Benign Prostatic Hyperplasia medication (alpha 1-blockers and 5-ARI)
* Known hypersensitivity to alfuzosin
* History of postural hypotension or syncope
* Combination with other alpha 1-blockers
* Hepatic insufficiency
* Unstable angina pectoris
* Severe concomitant condition threatening life
Naltrexone Implants vs. MMT Among Inmates in the Norwegian Correctional Services

The purpose of this clinical trial is to study the efficacy and safety of naltrexone implants as a relapse prevention for opiate addicted inmates about to be released from prison. The experimental group is compared with a control group that commences methadone maintenance treatment before release.

The hypothesises are that quality of life and criminal behaviour improve significantly in both groups compared to the month before incarceration. The experimental group is going to have significant less days with opioid use compared to the MMT group.

We hypothesize furthermore that the implants can prevent death related to opiate overdose up to 6 months after commenced treatment.

The probability of quick relapse to criminal activity and substance abuse after prison release is high among incarcerated opiate addicts.

We attempt to prevent relapse to opiate abuse by two different means:

Methadone Maintenance Treatment (MMT) versus Naltrexone implants, randomly allocated to two groups by sealed envelopes.

All participants may choose in which group to continue after 6 (and again after 12) months, when the implants supposedly stop releasing naltrexone.

The total treatment period is 18 months, continuation with MMT is optional after study termination.

Eligibility Criteria:
Inclusion Criteria:

* opiate addiction
* living in greater Oslo area

Exclusion Criteria:

* psychosis / major depression, currently not treated
* pregnancy
* liver enzymes: ASAT or ALAT \> threefold above upper boundary