cyrilzakka/clinical-trials huggingface dataset:
68-Ga PSMA 11 PET/MRI and 68-Ga RM2 PET/MRI for Evaluation of Prostate Cancer Response to HIFU Therapy

This study is being conducted to determine whether the combination of imaging agents 68-Ga RM2 and 68-Ga PMSA11 is better at assessing response to high intensity focused ultrasound (HIFU) or high dose rate (HDR) local therapy than standard imaging or biopsy in patients with known prostate cancer.

Primary Objective: To determine feasibility of 68Ga-PSMA-11 PET/MRI and 68Ga-RM2 PET/MRI for evaluation of HIFU or HDR local therapy in patients with known prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Known prostate cancer
* Planned HIFU or HDR local therapy
* Able to provide written consent
* Karnofsky performance status of 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent)

Exclusion Criteria:

* Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
* Metallic implants (contraindicated for MRI)
Positive Psychology in Suicidal Patients

Suicide is a major health concern. Weeks following psychiatric admission are a highly suicide risk period for those having current suicidal ideation or attempt. Recently, a pilot study suggested the feasibility of positive psychology in patients in suicidal crisis. Notably, gratitude exercises suggested improvement in optimism and hopelessness, two dimensions associated to suicide. Moreover, gratitude has been associated to suicidal ideation and attempt, independently from depression. Thus, investigators want to conduct the first randomized controlled study in order to assess effectiveness of gratitude exercises (vs control task) in suicidal inpatients, on 1) psychological pain reduction 2) suicidal ideation, hopelessness, optimism, depressive symptomatology, and anxiety improvement.

Study design: monocentric randomized controlled study

Methods:

206 inpatients (Department of Emergency Psychiatry and Post Acute Care), between 18 and 65 years-old, having attempted suicide before hospitalisation or having current active suicidal ideation at the time of the psychiatric hospitalisation. Patients suffering from schizophrenia are excluded.

Randomization into two groups: Positive Psychology (i.e., gratitude journal) (n = 103) or Control Task (i.e., food journal) (n = 103), daily exercises during 7 days (in add-on from usual treatment).

Clinical assessment: 1) at baseline (the day before the intervention beginning) (V0); 2) short daily self-assessments (immediately before and after the exercise); 3) the day following the last day of the intervention (V1).

* V0 : socio-demographic data, treatments, psychopathology, suicidal ideation,depressive and anxious symptomatology, psychological pain, optimism, hopelessness.
* Daily self-assessments: psychological pain, optimism, hopelessness
* V1 : treatments suicidal ideation,depressive and anxious symptomatology, psychological pain, optimism, hopelessness, intervention satisfaction.

Eligibility Criteria:
Inclusion criteria:

* Being hospitalized for suicidal thoughts or suicide attempt (from less than a week)
* Having signed informed consent
* Be fluent in French
* Able to understand nature, aims and methodology of the study

Exclusion criteria:

* Lifetime history of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders - V (DSM-V) criteria
* Current eating disorder according to DSM-V criteria
* Patient on protective measures (guardianship or trusteeship)
* Deprived of liberty subject (judicial or administrative decision)
Limberg and Karydakis Flap in Recurrent Pilonidal Sinus Disease

It was investigated whether there is a factor that can aid determination of the preferred technique by comparing the early Limberg flap and Karydakis procedure techniques for the treatment of recurrent pilonidal sinus.

Sacrococcygeal pilonidal sinus is common in young men and may recur overtime after surgery.

It was investigated whether there is a factor that can aid determination of the preferred technique by comparing the early Limberg flap and Karydakis procedure techniques for the treatment of recurrent pilonidal sinus.

Eligibility Criteria:
Inclusion Criteria:

1. Patients willing to give written informed consent
2. There should be recurrent pilonidal sinus

2. Recurrent adult patients (over 18 years of age) undergoing surgery for pilonidal sinus

3. International normalizing ratio (INR) less than 1.5

4. Prothrombin time (PT) should be less than 15 s

5. Partial thromboplastin (PTT) time should be near normal

6. Platelet count should be greater than 50,000 per mm3 to limit the risk of bleeding

7. There must be no infection at the time of surgery

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Exclusion Criteria:

1. Patients not willing to give informed consent
2. Age less than 16 years
3. Patient presenting with conditions mimicking pilonidal sinus
4. Diabetes mellitus, renal failure, immunosuppression e.g. were excluded

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The Effect of Virtual Reality on Postoperative Pain and Anxiety in Cardiac Surgery.

The objective of this study is to investigate the effect of VR on post-operative pain and anxiety management in cardiac surgery patients undergoing a coronary artery bypass grafting (CABG) procedure.

Participants in the intervention group will receive a 20 minute session with the head mounted VR device on post-operative days 1,2 and 3.

Participants in the control group will be treated with conventional post-operative care.

Objective: The objective of this study is to investigate the effect of VR on post-operative pain and anxiety management in cardiac surgery patients undergoing a coronary artery bypass grafting (CABG) procedure.

Study design: This study is a single-center randomized control trial.

Study population: Patients who have undergone a CABG procedure (n=100).

Intervention: The intervention group (n=50) will use the VR distraction therapy device at day 1, 2 and 3 after surgery on the general ward. The control group (n=50) will be treated with conventional post-operative pain and anxiety management.

Main study parameters/endpoints: The main study parameters at day 1, 2 and 3 after surgery. These are the Numeric Rating Scale (NRS) to assess the effect of pain on mobility, the Quality of Recovery-15 questionnaire, the State-Trait Anxiety Inventory-6 questionnaire and assessment of analgesic use. At follow-up, participants will be called to gather one-time QoR-15 and STAI-6 questionnaire data 6 weeks after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years or older with written informed consent
* Patients undergoing surgical CABG

Exclusion Criteria:

* Major comorbidities besides coronary artery disease
* Complicated surgical procedure
* Hearing and/or visual impairments
* Psychiatric impairments
* Complaints of vomiting and nausea
* History of epilepsy
* Claustrophobia
* Facial wounds and skin defects at site of application
* Patients placed in clinical isolation
* Readmission to the intensive care unit
Turkish Validity and Reliability of the Expanded Rehabilitation Complexity Scale

The RCS is a tool that can assess the need for complex rehabilitation and objectively indicate that a patient may have difficulty functioning well at home or in the community if their medical needs are still high. Among rehabilitation patients, there are still patients with complex needs, even though they have maximized rehabilitation potential. Moreover, RCS can also be useful in highlighting cases of patients becoming seriously ill during the rehabilitation process due to an acute illness such as sepsis, which significantly limits treatment time. This information can be emphasized using RCS data when requesting extended or increased rehabilitation support.

The Rehabilitation Complexity Scale (RCS) is similarly designed to provide a simple measure of the complexity of rehabilitation needs and/or interventions; This can be implemented in a timely manner and takes into account essential care, specialist nursing, therapy and medical interventions. Clauses in the RCS state that care, nursing, therapy and medical input needs are the primary 'causes' of case complexity and (together with length of stay) will ultimately affect a particular individual. Compliance in healthcare processes is a very current issue, with particular emphasis on the individualization of rehabilitation settings. Compliance has been described by WHO as a complex issue with various dimensions and definitions, and these vary between countries. However, most definitions of appropriateness address a set of basic requirements: that care be effective (based on valid evidence); be efficient (cost-effective); and is consistent with the ethical principles and preferences of the individual, society or society concerned. It is thought that RCS will meet these needs.The research population will be 110 patients selected from the patients hospitalized in the palliative unit of Istanbul Physical Therapy and Rehabilitation Hospital.The sample size was determined as 110. MEDCALC program was used in the analysis. Linear regression analysis was performed. Cronbach-alpha was calculated as 97%.Stabil subacute stroke patients will be included in the study. Barthel, FIM, RCS-E tools will be used in the study.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnoses of stroke -

Exclusion Criteria: unstable cardiac and neurovascular disease

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A Study to Determine the Safety, Tolerability and Efficacy NW-3509A in Patients With Chronic Schizophrenia

A 4-week Phase IIa study to evaluate the safety and tolerability and efficacy of NW-3509A in patients with chronic schizophrenia that are not responding adequately to their current antipsychotic medication (aripiprazole or risperidone). NW-3509A is given as an oral dose range of 15 to 25 mg, BID in a 1:1 ratio.

This is a prospective, 4-week, randomized, double-blind, placebo-controlled, study designed to evaluate the safety, tolerability, and preliminary efficacy of an oral dose range of NW-3509A of 30 to 50 mg/day (15 to 25 mg, BID) in patients with chronic schizophrenia on a stable dose of an antipsychotic (aripiprazole or risperidone). A minimum of 90 patients will be randomized in a 1:1 ratio to receive either NW-3509A (n=45) or placebo (n=45). Dose increases will be performed only during in-patient setting.

Safety and efficacy assessments will be done on a weekly basis during the randomized treatment period. The assessment of safety will be based on laboratory tests (biochemistry, hematology, and urinalysis), 12-lead standard ECG, vital signs, physical examinations, neurological examinations, C-SSRS, ESRS-A, subjective reporting of any AE by the subject, objective observation of any AE by the Investigator. Pharmacokinetic samples will be taken at various time-points. Efficacy assessments will include the PANSS, CGI-C, CGI-S and the Strauss-Carpenter Level of Functioning (LOF) scale.

Eligibility Criteria:
Inclusion Criteria:

1. Male/female; if female, must not of childbearing potential
2. 18 to 65 years of age, inclusive;
3. Has a current diagnosis of schizophrenia
4. Has a total score on the PANSS \< 75.
5. Positive symptoms sub-scale score not to exceed 15; score of ≥4 on no more than 2 positive symptoms
6. Has a Clinical Global Impression - Severity of disease (CGI-S) rating of mildly to moderately severely ill.
7. Is in need of anti-psychotic treatment and is currently receiving a stable dose (minimally for 4 weeks prior to screening of oral risperidone or aripiprazole (at least 2 mg risperidone dose-equivalent).
8. Current symptoms present for at least one month.
9. Patient agrees to be hospitalized for up to 2 days at the start of dosing and at each dose increase
Low Field Magnetic Stimulation Treatment for Bipolar Depression

Individuals with bipolar depression who had a particular kind of brain imaging reported improved mood after the imaging. This effect may be linked to the changing magnetic fields used during these magnetic resonance imaging studies. The current studies are designed to further explore the important parameters of this effect and to clarify the degree and duration of the mood effects.

An initial study using proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) in bipolar depressed individuals was associated with reports of improved mood. These studies employed oscillating magnetic fields similar to those used in functional MRI (fMRI), but which differ from the usual fMRI scan in field direction, waveform frequency, and strength. As the abbreviation EP-MRSI is used to describe several relatively common MR sequences, the specific potential clinical procedure being used is referred to as low field magnetic stimulation or LFMS. Following these initial results, investigators are conducting studies to determine the critical variables in both subjects and treatment for optimal response. Studies are also underway to characterize the response of specific depression symptoms, the degree of response, and the duration of response.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of bipolar disorder.
* Current depression.

Exclusion Criteria:

* Contraindication for MRI due to metal in eyes/head
* Claustrophobia.
* Inability to lie flat.
* History of brain injury.
Identification of the Molecular And/or Pathophysiological Bases of Developmental Diseases

Developmental diseases include more than 3000 diseases and can associate organ malformation, dysmorphism, development disorders and/or intellectual deficiency. Even though the considerable effort in the search for genes in the last 20 years has led to the identification of thousands of genes associated with Mendelian diseases, half of the individuals with severe development anomalies remain without a genetic diagnosis. It is important to pursue the ambition to contribute to the goal fixed by Europe, namely the identification of the large majority of genes responsible for rare diseases with development anomalies, and to be able to provide genetic counselling to patients and their families. In the past, scientific research to discover genes required a large number of families and individuals and was slow and expensive to carry out. Today, this approach has been facilitated by next generation sequencing.


Eligibility Criteria:
Inclusion Criteria:

* Patients (foetus/children and adults) with development anomalies whose molecular bases are unknown, or for which the pathophysiological mechanism is poorly understood
* Consent of the patient or his/her legal representative
* Suitable level of understanding

Exclusion Criteria:

* Patients without national health insurance cover
Phototherapeutic Keratectomy (PTK) on Recurrent Corneal Erosions

To determine the ten-year visual results and outcome of excimer laser phototherapeutic keratectomy (PTK) for recurrent corneal erosions.

A retrospective chart review of 26 eyes of 23 patients with recurrent corneal erosions treated by PTK from 1996 to 2000 was performed. All eyes had failed to respond to conventional therapy. Data regarding the preoperative and postoperative best-corrected visual acuity (BCVA), spherical equivalent (SE), symptomatic relief, incidence of recurrence, and complications arising from the laser treatment were analyzed. The mean duration of symptoms prior to PTK was 18 months (range, 8 to 36 months). The corneal epithelium was debrided, and laser ablation was performed to a depth of 5 micron with an ablation zone of 7 to 9 mm, using the Technolas 217C Plano Scan excimer laser. Mean postoperative follow-up was 12 years (range, 10 to 14 years).

Eligibility Criteria:
Inclusion Criteria:

Recurrent corneal erosions Patients 21 to 50 years old Conventional treatments have failed

Exclusion Criteria:

* Diabetes
* Autoimmune diseases
A Study of ZSTK474 in Japanese Patients With Advanced Solid Malignancies

To evaluate the safety (adverse events and dose-limiting toxicity) of daily oral doses of ZSTK474 in patients with advanced solid malignancies.

Open-label, uncontrolled, serial cohort, dose-escalation study evaluating two different dosing regimens (Arm 1: cycles of 5 days on drug and 2 days off drug), Arm 2: cycles of 21 days on drug and 7 days off drug).

Eligibility Criteria:
Inclusion Criteria:

* Japanese males or females \>= 20 years old
* Advanced (metastatic or unresectable) solid tumor
* ECOG performance status score of 0 or 1 and expected survival \>12 weeks
* Recovered from hematological toxicities of prior cancer therapies

Exclusion Criteria:

* Previous treatment with PI3K inhibitor
* Serious/significant illnesses or underlying conditions, including diabetes or hepatic renal or CV disease.
* Other investigational agent within previous 4 weeks
* Participating in another clinical study
EDMONd - Elemental Diet in Bowel Obstruction

A feasibility study to provide 'proof of concept' of Elemental Diet (ED) as an acceptable/ useful feeding option for patient with inoperable malignant bowel obstruction and to examine the impact of ED on quality of life

The aim of this study is to determine whether Elemental Diet (a type of drink that contains an elemental protein source known as amino acids) can be tolerated by patients with inoperable bowel blockage who can no longer eat and are only able to swallow small amount of fluid. The objective is to find out whether elemental diet (ED) can be used as an acceptable nutrition and whether it improves the quality of life. Bowel blockage is a common complication in patients with ovarian cancer. Unfortunately when the cancer is advanced, this blockage can occur in many parts of the bowel therefore surgery is not possible. Every year in the UK some publications report the rate as high as 50% . One way to feed patients with bowel blockage is through the veins; this is known as parenteral nutrition (PN) however PN is rarely used in United Kingdom. Patients with malignant bowel blockage are often able to swallow small amounts of liquid but if they have no PN they are only able to survive for 2-3 weeks and the psychological as well as physical impact on patients and the family are very distressing. ED is a type of a drink which contains an elemental protein source known as amino acids. ED drinks are almost totally absorbed in the upper part of the bowel and therefore could be absorbed even in patients who have bowel blockage which usually develops lower down in the gut. If this study is successful and proves that ED can be tolerated and provide nutrition to patients with inoperable bowel blockage it will be a big step towards improving the quality of life at the final stage of cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Confirmed inoperable bowel obstruction due to disseminated malignancy
* Ability to tolerate 500ml of liquid
* Capacity to give informed consent

Exclusion Criteria:

* Bowel obstruction that can be managed with surgical intervention
* Complete bowel obstruction and inability to tolerate small amount of liquid
Measuring Quality of Medical Student Performance at Contextualizing Care

During the project, fourth-year medical students participating in a Medicine sub-internship will be randomized to an intervention group or a control group; the intervention group will receive additional training in the application of qualitative methodology to elicit and incorporate contextual factors in the clinical encounter. All students will participate in an SP assessment consisting of four standardized patients (SPs), blinded to trial arm, presenting cases with and without important biomedical and contextual factors in a counterbalanced factorial design. Performance will be compared between trial arms; the investigators hypothesize better performance in the intervention arm. In addition, performance will be compared with United States Medical Licensing Exam (USMLE) Step 2 clinical knowledge scores to determine whether contextualizing ability is independent of clinical knowledge, and consistency of performance across individual SP cases will be studied to determine the number of cases necessary to achieve sufficient reliability for the assessment to be used.

Clinical decision making requires two distinct skills: the ability to classify patients' conditions into diagnostic and management categories that permit the application of "best evidence" guidelines, and the ability to individualize or - more precisely - to contextualize care for patients whose circumstances and needs require variation from the standard approach to care. Most assessment in medical education places heavy emphasis on biomedical decision-making with little emphasis on how to incorporate contextual factors that may be essential to planning patients' care.

The goal of this project is to demonstrate and provide validity evidence for an innovative standardized patient (SP) method of assessing medical students in the clinical years on their ability to detect and respond to individual contextual factors in a patient encounter that overcomes the aforementioned challenges.

During the project, fourth-year medical students participating in a Medicine sub-internship will be randomized to an intervention group or a control group; the intervention group will receive additional training in the application of qualitative methodology to elicit and incorporate contextual factors in the clinical encounter. All students will participate in an SP assessment consisting of four SPs, blinded to trial arm, presenting cases with and without important biomedical and contextual factors in a counterbalanced factorial design. Performance will be compared between trial arms. In addition, performance will be compared with United States Medical Licensing Exam (USMLE) Step 2 clinical knowledge scores to determine whether contextualizing ability is independent of clinical knowledge, and consistency of performance across individual SP cases will be studied to determine the number of cases necessary to achieve sufficient reliability for the assessment to be used.

Eligibility Criteria:
Inclusion Criteria:

* Fourth-year medical students at University of Illinois at Chicago
Minimal Access Repair of Contralateral Hernias (MARCH Trial)

Repair of unilateral inguinal hernia in infants. Laparoscopic repair, with closure of contralateral patent processus vaginalis if present, versus open repair


Eligibility Criteria:
Inclusion Criteria:

* unilateral inguinal hernia

Exclusion Criteria:

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Efficacy of a Long Term, High Intensity and Long Time Stretch Training Program on Viscoelasticity Plantarflexors Muscle in Children With Cerebral Palsy (CP).

Children with cerebral palsy present early in the childhood altered muscular properties, as soon as structural or stiffness. In the gastrocnemius muscle, altered muscular properties are characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion.

This study assess efficacy of a long term stretching program of plantarflexors muscle on their viscoelasticity properties and maximal dorsiflexion angle gain. Stretching program is characterized by 3 phases: baseline, intervention and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 8 to 16 years
* Children diagnosed spastic cerebral palsy
* Children with decrease maximal dorsiflexion angle under +5° in the last four weeks
* Children who don't understand instructions

Exclusion Criteria:

* Children who had damage orthopedics or surgical operation contraindicating realization of the experimental protocol
* Hospitalization incompatible with the progress of the protocol.
* Children who had botulinum injection, extensions casts or the implementation of new equipment (night or day orthosis) for less than three months or the progress of the protocol.
* Children having analgesic treatment in progress