cyrilzakka/clinical-trials huggingface dataset:
A Metacognitive Group Therapy of Depression and Anxiety in Youth With Autism

The goal of this open clinical trial is to try out and evaluate a group metacognitive treatment protocol, for adolescents aged 15-18 years of age with anxiety and/or depression and an autism diagnosis.

The main questions it aims to answer are:

1. How does the recruitment to the study work and what is the retention rate?
2. What is the level of participant compliance?
3. Is the treatment adherence satisfactory, are there any practical problems with treatment delivery?
4. Are the outcome measures and assessment procedures feasible?
5. Do the participants accept the treatment, are there any reports of adverse effects?
6. What are the preliminary effects of the treatment regarding

   1. Symptoms of anxiety and/or depression
   2. Quality of life
   3. Functional impairment
   4. Subjective level of stress
   5. Central metacognitive processes
7. Are changes in metacognitive processes related to changes in anxiety and depression?

The participants will partake in metacognitive group treatment of 10 sessions following an initial screening.

Participants in the study are youth (15 to 18 years of age) seeking help for anxiety and depression within child and youth psychiatry. There will a consecutive inclusion to form 6 treatment groups with 6 persons in each. The groups will meet once every week. Assessments will take place at pre- and post-treatment as well as at 6-month follow-up. Some metacognitive processes will also be monitored at each group session. The therapists have undergone a specialist training in metacognitive therapy and are experienced in using the methods. The main focus of the study is on feasibility, acceptability and preliminary effects of the treatment. These will be analyzed with paired sample t-test on primary and secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age of 15 to 18 years
* Seeking medical care PRIMA psychiatric clinic for children and youth in Stockholm
* Diagnoses of anxiety disorder or depression as well as autism established in a clinical interview
* Mastering the Swedish language enough to take part of the treatment
* Willingness/ability to participate after receiving information about what participation entails

Exclusion Criteria:

* Assessed to meet one of the following diagnoses: Bipolar syndrome, alcohol use syndrome, substance use syndromes, psychotic symptoms and affective syndromes with psychotic symptoms and antisocial personality disorder.
* Assessed to have a high suicide risk.
* Assessed to have extensive self-harm behavior or moderate to high risk of such.
* Participating in other psychological treatment or about to start such treatment during the time interval of the study.
* Has not had stable medication in the last month or is planning a deposit/medication adjustment during the time interval of the study.
Effects of Virtual Reality Application on Pain Reduction and Cerebral Blood Flow in Robot Training in Burn Patients

The purpose of this study is to determine whether the application of virtual reality (VR) is effective in reducing training pain in robot-assisted gait training (RAGT) in patients with lower extremity burn. The investigators investigated through an analysis of the activation status over time in the prefrontal cortex using functional near-infrared spectroscopy (NIRS).

Burn injuries and their treatment are considered to be among the most painful a person can endure. Therefore, new modalities that prove effective with burn patients are expected to improve clinical outcomes when applied to painful therapies. The purpose of this study is to determine whether the application of virtual reality (VR) is effective in reducing training pain in robot-assisted gait training (RAGT) in patients with lower extremity burn. The investigators investigated through an analysis of the activation status over time in the prefrontal cortex using functional near-infrared spectroscopy (NIRS). RAGT was performed 10 times for 2 weeks from Monday to Friday, and the cerebral blood flow measurement using NIRS was measured 3 times each while applying or not applying VR for 30 minutes as long as the RAGT is in progress. The VR program provided non-immersive VR walking along a forest path or a coastal path according to the walking speed while the RAGT was in progress. For each physical therapy session, each patient spent equal amounts of time in VR and in the control condition (without VR). The average of oxy-Hb and deoxy-Hb of each session was measured for 10 days. In the prefrontal cortex, the levels of hemoglobin (Hb) were measured using the fNIRS measurement system. Average values of both oxy-Hb and deoxy-Hb were calculated at four stages : temporal delay time with RAGT, RAGT without VR, temporal delay time with VR, RAGT with VR. Before training, all patients verbally rated their most severe pain during physical training as a score of 5 or higher on a visual analog scale (VAS) of 0 to 10, where 0 presents " no pain at all" and 10 presents " worst pain". Pain, the primary dependent variable, was measured immediately after each experimental treatment. Patient rated (1) their worst pain (no pain to worst pain), and (2) their average pain ( no pain or worst pain).

Eligibility Criteria:
Inclusion Criteria:

* partial-to-full-thickness burns that had spontaneously healed or required skin grafting
* all patients rated their most severe pain during robot assisted gati training (RAGT) as a score 5 or higher on a visual analog scale of 0 to 10, where 0 represents no pain at all, and 10 represents worst pain.
* 1 ≤ functional ambulation category (FAC) score ≤ 3

Exclusion Criteria:

* patients with history of brain injury
* cognitive disorders, intellectual impairment before burn injury
* problems with weight bearing due to unstable fractures
* body weight ≥100 kg
* severe fixed contracture
* skin disorders that could be worsened by RAGT and conventional rehabilitation
The Development of Skin Adhesive Patches for the Monitoring and Prediction of Mental Disorders

development of skin adhesive patches for the monitoring and prediction of mental disorders


Eligibility Criteria:
Inclusion Criteria:

* the existence of a current Major depressive disorder or panic disorder during the screening and baseline visits, per the Mini-International Neuropsychiatric Interview (Sheehan et al., 1998) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* scored at least 16 on the HDRS-17 (Hamilton, 1960) for MDD and 7 on the Panic disorder severity scale for panic disorder patients at the baseline visits.

Exclusion Criteria:

* Patients who had psychotic disorder (e.g., schizophrenia or delusional disorder), bipolar affective disorder,active alcohol or drug use disorder, neurological illness including significant cognitive impairment or Parkinson's disease, mental retardation, significant medical conditions, epilepsy, histories of alcohol or drug dependence, personality disorders, or brain damages
* patients who were at serious risk for suicide of homicide
Hand Rehabilitation Based on a RobHand Exoskeleton in Stroke Patients: a Case Series Study

The following study seeks to provide information regarding to the RobHand exoskeleton for hand neuromotor maintenance and/or rehabilitation, developed by the University of Valladolid, Spain.

The following study seeks to provide information regarding to the RobHand exoskeleton for hand neuromotor maintenance and/or rehabilitation, developed by the University of Valladolid, Spain. The study was carried out by the Neurotchnology Group of the Research and Development Area of the Corporación de Rehabilitación Club de Leones Cruz del Sur, Chile. Clinical test were implemented on four subjects with Stroke sequelae who participated in two evaluations of manual function and 16 training sessions with the robotic exoskeleton, in order to know the clinical effects on manual function, safety and satisfaction of users who utilize the exoskeleton RobHand.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Active patient at the Rehabilitation Center Club de Leones Cruz del Sur
* At least 1 Hemorrhagic or ischemic stroke
* Adequate level of consciousness
* Paresis of the upper extremities
* Patient who signed the inform consent

Exclusion Criteria:

* Comorbidities in the central nervous system
* Pain in the upper extremity (hand, forearm, arm)
* Patient who does not sign the informed consent
CNAP™ Monitor Study

A newly developed monitor for continuous non-invasive blood pressure monitoring (CNAP™ Monitor 500; CNSystems Medizintechnik AG, Graz, Austria) provides beat-to-beat BP readings and is non-invasive. To make sure that anaesthesiologist can rely on and make clinical decisions based on values provided by the CNAP™ monitor, to demonstrate its reliability we will test it during the perioperative care of children.


Eligibility Criteria:
Inclusion Criteria:

* Patients who will already be having an indwelling arterial cannula placed for their surgical procedure.

Exclusion Criteria:

* Patients with history of a peripheral neurologic or neuropathic disorder.
* Patients in whom an invasive arterial cannula cannot be placed.
* Patients with vascular implants at the sites of non-invasive blood pressure measurement (fingers and upper arm of the examined arm).
* Edematous patients.
* Patients who are less than 20 kg.
Sacroiliac (SI) Screws: The Effect of SI Screw Removal on Patient-Reported Pain and Functional Outcomes

Chronic pain following surgical stabilization of a pelvic fracture is very prominent and can have a major affect on a patient's quality of life. Persistent pain after radiographic evidence of fracture union commonly leads to implant removal. But, the routine removal of orthopaedic fixation devices after fracture healing remains an issue of debate.

Many surgeons remember patients whose intractable, hardly explainable local symptoms and complaints of pain resolved quickly after a hardware-removal procedure. However, implant removal requires a second surgical procedure in scarred tissue, poses a risk for nerve damage, infection and re-fractures, and is not a guarantee of pain relief.

Rates of implant removal vary based on anatomic location and implant selection. Many studies have introduced and assessed the outcomes of hardware removal in the ankle, tibia and femur. But, there is currently no controlled trial that assesses the benefits and harms of sacroiliac (SI) screw removal in pelvic fracture patients.

Reports in literature are not consistent concerning the incidence of painful hardware and the outcome and pain relief after hardware removal. There is conflicting evidence that removing hardware decreases acute pain in ankle, tibia, and femur fractures but there is a need to explore the effect of SI screw removal in pelvic fracture patients. The investigators propose to prospectively randomize patients with a pelvic fracture requiring the use of SI screws for stabilization to removal versus non-removal of SI screws and track which group has less pain and need for narcotic pain medications.

Eligibility Criteria:
Inclusion Criteria:

* The patient is between 18 and 80 years of age, inclusive
* The patient has a pelvic fracture that required SI screw stabilization
* The patient has reached skeletal maturity
* The patient's pelvic fracture was the result of trauma (includes polytraumatized patients)
* The patient is English-speaking
* The patient's pelvic fracture was initially treated at Shock Trauma
* The patient is currently experiencing pain associated with his/her pelvic fracture
* The patient's surgeon agrees to randomization (the patient is amendable to either SI screw removal or non-screw removal treatment)
* The patient is able to be randomized between 4 and 8 months post-SI screw stabilization surgery at an orthopaedic follow-up appointment

Exclusion Criteria:

* The patient is non-ambulatory due to an associated spinal cord injury
* The patient was non-ambulatory pre-injury
* The patient is currently pregnant
* The patient is enrolled in another study that does not allow co-enrollment
* The patient is likely to have severe problems with maintaining follow-up
Different Types of Electrostimulation Probes During IONM

Intraoperative nerve monitoring is often used in many centers during thyroidectomy. According to the investigators' knowledge, there's no study showing superiority between bipolar and monopolar stimulation probes used for nerve monitoring during thyroid surgery. In this study, the investigators aimed to compare two different types of probes and find out superiorities.Twenty-one patients who underwent primary total thyroidectomy or hemithyroidectomy were included in the study. During surgery, amplitude and latency values obtained in the same patient with both bipolar and monopolar stimulation probes from 10 different anatomical spots \[vagal nerve, recurrent laryngeal nerve inferior portion, recurrent laryngeal nerve superior portion, external branch of superior laryngeal nerve (EBSLN)\] were recorded prospectively, both when sheath was intact and after being dissected.


Eligibility Criteria:
Inclusion Criteria:

* who underwent thyroid surgery

Exclusion Criteria:

* Perioperative loss of electromyographic(EMG) signal (LOS) during intraoperative nerve monitorization
* patients with additional pathology that may affect vocal cord function,
* abnormal preoperative laryngeal examination
* history of thyroid, vocal cord or other neck surgery
* advanced cancer, RLN, esophageal or trachea invasion
Prevention of Complications of Eye Surgery

This study was designed to investigate pre-operatively measured parameters of various anaesthetic regimes, iris color, sex, age, surgical time, severity of Marcus-Gunn Pupil (MGP), type of mechanical stimulation of eye, and number of extraocular muscle (EOM) under tension as predictors of significant OCR in pediatric strabismus surgery.

Objectives: Despite various proposed maneuver, successfully predicting an oculocardiac reflex (OCR) is difficult to achieve. This study was designed to investigate pre-operatively measured parameters of various anaesthetic regimes, iris color, sex, age, surgical time, severity of Marcus-Gunn Pupil (MGP), type of mechanical stimulation of eye, and number of extraocular muscle (EOM) under tension as predictors of significant OCR in pediatric strabismus surgery.

Methods: Three hundred patients were randomized to one of three anesthetic regimes: group P: propofol (2 mg/kg), alfentanil 0.02 mg/kg, and atracurium 0.5 mg/kg at induction; group K: ketamine (2mg/kg), alfentanil 0.02 mg/kg, and atracurium 0.5 mg/kg at induction; group T: thiopental (5mg/kg), alfentanil 0.02 mg/kg, and atracurium 0.5 mg/kg at induction. OCR was defined as a 10% change in heart rate induced by traction.

Results: Incidence of OCR was significantly lower in patients in group k compared with patients in group T or P. Chi-square test results showed that the occurrence of OCR was significantly associated with difference of iris color (P=0.01). The occurrence of the OCR did not correlate with sex, age, duration of surgery, iris color, severity of MGP, number of EOM under tension, and type of mechanical stimulation of eye. Type of mechanical stimulation of eye or number of EOM under tension increased risk of developing OCR by 0.81 (95% CI, 0.66-0.98) and 1.29 (95% CI; 1.12-1.63) respectively.

Conclusions: Induction of anesthesia with ketamine is associated with least hemodynamic changes induced by OCR during strabismus surgery. The prediction of oculocardiac reflex propensity remains elusive.

Eligibility Criteria:
Inclusion Criteria:

* 300 ASA physical status I or II patients, aged 2-18 years, who candidate for elective strabismus surgery

Exclusion Criteria:

* trauma to eye, ASA III or IV, who had contraindication for using thiopental, ketamine, or propofol, had cardiovascular diseases or had taken cardiovascular drugs
Elevated Platelet Count as Prognostic Factor in Colorectal Cancer With Synchronous Liver Metastases

Colorectal cancer (CRC) is the third most common malignancy worldwide and is often metastatic at diagnosis. Despite progresses in surgical techniques and the introduction of novel chemotherapy regimens, many patients still suffer from a poor prognosis. It is therefore of utmost importance to identify prognostic markers that may improve selection of patients.

In recent years several studies demonstrated that preoperative blood tests as platelet count or neuthophil-to-lymphocyte ratio could be prognostic factors in CRC as well as other malignancies. The aim of this study was to evaluate the role of preoperative platelet count (PC) in patients with synchronous colorectal liver metastases.


Eligibility Criteria:
Inclusion Criteria:

* Colorectal cancer with synchronous liver metastases
* Possibility to retrieve pre-operative platelet count
* Age of 18 years or older
* Availabilty of clinical-pathological data
* Minimum follow up of 12 months

Exclusion Criteria:

* None
Does Meloxicam Provide as Much Pain Relief as Opioids After Shoulder Surgery?

The opioid epidemic continues to be a major concern, with orthopedic surgeons being among the top prescribers of opioids. Studies evaluating these practices found that opioids are overprescribed, even for common procedures. Patients undergoing arthroscopic labrum repair of the shoulder were found to have an average of 20 pills left over after surgery. Many strategies have been developed to tackle overprescribing and have found success, including no opioid protocols for carpal tunnel release. The purpose of this study is to examine if meloxicam alone provides similar patient reported outcomes to opioids following arthroscopic labrum repair of the shoulder.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Scheduled for arthroscopic labrum repair of the shoulder

Exclusion Criteria:

* History of opioid, acetaminophen, NSAID or local anesthetic allergy or intolerance, or contraindications to these medications.
* Currently on long-term preoperative narcotics
* Scheduled for revision arthroscopic repairs of the shoulder
* Unable/unwilling to consent for enrollment
* Unable to complete postoperative surveys
* History of chronic pain syndromes (fibromyalgia, chronic diffuse MSK pain, etc)
* Patients under the age of 18
* Pregnant or breastfeeding women
* Scheduled for concurrent procedures
Effect of OMEGA 3 Fatty Acids on Lactation Period

The World Health Organization (WHO) and the United Nations Children's Fund (UNICEF)

recommend that babies be exclusively breastfed for the first 6 months from birth. The composition of breast

milk is dynamic and may vary according to the content of maternal nutrition. Maternal nutrition, on the other

hand, determines the quality of breast milk necessary for the adequate growth and health of infants. For this

reason, the content of the maternal diet is important during the lactation period, which is the critical stage that

can affect the development of infants.

Omega 3 fatty acids are essential unsaturated fatty acids that are not synthesized by the human body and must be obtained through diet. The polyunsaturated fatty acids (PUFAs) most abundant in the diet are short-chain omega 3 alpha linolenic acid (ALA) and omega 6 linoleic acid (LA), which are mostly found in vegetable oils. ALA is a plant-derived omega 3 fatty acid found in flaxseed, walnut, canola and soybean oils. Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are found in marine sources such as seafood and fish oils. Today, the use of Omega 3 fatty acid supplements is increasing during the lactation period. However, consumption of omega 3 fatty acid sources during pregnancy or lactation is thought to be an important factor in preventing cancer risk. In our study, the investigators aimed to compare the maternal diet and the consumption of fish oil, flaxseed oil and walnut oil supplements during the lactation period, to compare the amount of prolactin and DHA in the milk composition and to compare the protective effects against breast cancer with cancer stem cell markers. For this study, 32 healthy Wistar pregnant rats, weighing 200-250 g, 8-10 weeks pregnant and not included in any experiments, will be used. Supplementary oils will be administered by oral gavage, considering the 0.5 g/kg body weight of the pregnant rats according to the groups they are assigned to, during the entire standard lactation period (day 21), considering the day of birth of the pregnant rats as the 0th day of lactation. Mother rats will be sacrificed under anesthesia at the end of the 21st day of lactation, mammary tissues will be taken into appropriate solutions and histopathological and immunohistochemical examinations will be performed. In addition, cardiac blood will be drawn and blood and tissue biochemical analyzes will be performed.


Eligibility Criteria:
Inclusion Criteria:

* healthy rats

Exclusion Criteria:

* patient rats
* rats that cannot be gavaged
Clinical Trial for Assessment of Safety and Efficacy of a Echinacea/Sage Spray Compared to a Chlorhexidine/Lidocaine Spray in the Treatment of Acute Sore Throats

The aim of the study is to show non-inferiority of an echinacea/sage spray compared to a chlorhexidine/lidocaine-spray in the treatment of acute sore throat during five days of treatment.

Main outcome parameter is the non-inferiority in number of responders between the two treatment groups. A responder is defined as a reduction by 50% of the total baseline score taken prior to treatment start. The symptoms are assessed with a symptom score.

Further secondary parameters are :

Responders during at day 4 and 5, single symptom scores during 1 to 5 days of observation, pain at begin and end (100mm VAS), assessment of efficacy by physician and patient, consumption of rescue medication

Assessment of safety by physician and patient, frequency of adverse events

Eligibility Criteria:
Inclusion Criteria:

* Age \> 12 years;
* Acute pharyngitis or tonsillitis with symptoms of throat pain and inflammation of the pharynx and/or tonsils;
* Onset of sore throat less than 72 hours before inclusion ;
* A Tonsillopharyngitis Severity Score ≥6;
* Written informed consent.

Exclusion Criteria:

* Analgesics \<12 hours;
* Antibiotics \<24 hours; t
* Topical throat pain medication \<4 hours;
* Systemic corticosteroids within the last month;
* Symptoms of primary bacterial pharyngitis or secondary bacterial infection;
* Serious illness such as tumors; allergy to one of the ingredients; pregnancy or lactation;
* Hypersensitivity to ibuprofen;
* Participation in another clinical trial in the previous 30 days.
Imaging and Omics for Cardiovascular Risk During NASA Deep Space Missions

The purpose of this study is to develop new approaches for screening astronauts for cardiovascular risk during deep space missions.

The purpose of this study is to develop new approaches for screening astronauts for cardiovascular risk during deep space missions. In this protocol, two different forms of imaging will be used to evaluate coronary plaque development (CT coronary angiography) and microvascular function (myocardial contrast echocardiography) to stratify CV risk. Based on this stratification, "omic" patterns (targeted metabolomics, lipidomic, and whole genome sequencing) will be assessed to determine whether there are any patterns that can add to existing predictive models. Outcomes measures will involve correlation of "omic" patterns to incremental risk scaling from lowest (no plaque and normal endothelial function) to highest (+ plaque and endothelial dysfunction).

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for clinically indicated CT coronary angiography within 6 months
* No obstructive coronary plaque and an Agatston score of 0 or At least one obstructive coronary plaque \<50% diameter and one other high risk feature on CT-A (positive remodeling, scattered calcification, low Hounsfield units, or "napkin ring" sign.

Exclusion Criteria:

* Known CAD or other atherosclerotic disease
* Valvular heart disease (moderate or more) and congenital heart disease
* Heart failure
* Pregnancy
* Allergy to ultrasound contrast agent.
* Right to left shunt