cyrilzakka/clinical-trials huggingface dataset:
Study to Assess the Non-inferiority of Pamorelin® 11,25mg SC Injected Versus Pamorelin® 11,25mg IM Injected in Patients Suffering From Advanced Prostate Cancer (PAMOJECT)

The active ingredient of Pamorelin® 11,25 mg is Triptorelin. Triptorelin is a substitute for a natural hormone produced in the body called Gonadotrophin-releasing hormone (GnRH). GnRH is a hormone secreted by hypothalamus (a gland located in brain) and controls the production of sex hormones (eg testosterone in men) in other organs in the body. The growth of prostate cancer cells, one of the most common cancers in men, is induced by the hormone testosterone. Hormonotherapy is one of treatments available to treat this type of disease by controlling the testosterone serum level. Pamorelin® 11,25 mg is normally injected in the muscle but this type of injection is not suitable for every patient. Therefore the primary purpose of this study is to assess the non-inferiority of the 12-week triptorelin formulation Pamorelin® 11,25 mg administered via subcutaneous (SC) injection as compared to Pamorelin® 11,25 mg administered via standard intramuscular (IM) injection based on the percentage of patients presenting a testosterone level ≤ 50 ng/dl at week 24.


Eligibility Criteria:
Inclusion Criteria:

* Histological proven prostate cancer, locally advanced or metastatic and scheduled to receive hormonal deprivation therapy
* Life expectancy of more than 9 months
* Documented testosterone levels of ≥ 125 ng/dl measured by any laboratory or on site within the previous 6 months

Exclusion Criteria:

* Has a history of hypersensitivity to the Investigational Medicinal Product or drugs with a similar chemical structure
* Has previously received a GnRH analogue, estrogens or a steroidal anti -androgen within the last year preceding the study
* Concomitant anti-coagulation treatment
* Patient who underwent an orchidectomy or who is scheduled to receive an orchidectomy during the course of this study
* Patient with known spinal medullar compression
Assessment of Diurnal Salivary Cortisol Production in COVID-19

In the year of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic several studies have focused on the effect of the COVID-19 on the adrenal cortex, demonstrating conflicting results. Herein, researchers sought to investigate the adrenal response in patients with COVID-19by assessing the diurnal rhythm of salivary cortisol and the adrenal androgen dehydroepiandrosterone (DHEA), as well as the plasma levels of aldosterone and adrenocorticotropic hormone (ACTH) in consecutive patients before the possible therapeutic administration of dexamethasone. To elucidate the potential association between the magnitude of individual immune response and the adrenal cortex response we included serum measurements of interleukin - 6 (IL-6).

All adult consecutive patients that visited the emergency department of the LAIKO General Hospital of Athens from May to July 2021 due to confirmed COVID-19 and related symptomatology were eligible for the study.

Age and gender matched healthy individuals without COVID-19 who had never been treated with GCs and fulfilled the exclusion criteria were also recruited from the Hospital's personnel and included in the analysis as Controls.

Blood samples were obtained immediately upon admission for the measurements of ACTH, IL-6 and aldosterone, which were performed by electrochemiluminescence assays on the cobas e 801 immunoassay analysers (Roche Diagnostics GmbH). Salivary samples for free cortisol and DHEAS were obtained during the next day using the Salivette (Sarstedt, Nümbrecht, Germany) at different time points 0800, 12.00, 18.00, and 22.00. Within 24h after saliva collection the salivettes were centrifuged at 2400 g for 20 min in 4 °C and aliquots were stored at -80 °C and analyzed by an Immunochemiluminescence assay in a Roche COBAS E411 analyzer.

Eligibility Criteria:
Inclusion Criteria:

Adult patients that visited the Emergency Department of LAIKO General Hospital of Athens, Greece from May to July 2021 due to confirmed COVID-19 and related symptomatology

Exclusion Criteria:

(i) pre-existing hypoadrenalism or concurrent systemic glucocorticoid treatment (ii) patients with chronic kidney disease stage 3b and above, (iii) patients with advanced metastatic disease.
Assessment of the Capability of PulmoVista 500 to Continuously Monitor Changes of Ventilation Over Time

The results of this study will help to define the capability and reliability of PulmoVista 500 to detect changes in both global and regional ventilation.


Eligibility Criteria:
Inclusion Criteria

- The population included in the clinical study will be selected from a pool of patients undergoing respiratory support who are scheduled to have their ventilation settings changed.

As a subgroup, patients who are scheduled for surgeries that need one-lung-ventilation (OLV) will be enrolled to the study.

* Male and female patients at the age of 18 years or older
* On respiratory support in ICU care or scheduled for such ( e.g. postoperatively) or scheduled for surgery with OLV
* Patients of which the monitoring of ventilation distribution may be of clinical interest
* Patients being ventilated via an artificial airway with a mechanical ventilator that is compatible with PulmoVista 500
* Patients scheduled for changes in ventilation settings that may cause relevant changes in the ventilation
* Chest circumference between 70 and 150 cm
* Written informed consent to participate in the study provided by either the patient or the legal representative of the patient.

Exclusion Criteria

* Currently has a permanent or temporary pacemaker, implantable cardiac device (ICD) or other device emitting electrical energy
* a BMI ≥ 50
* tidal volume (VT) ≤ 200 mL
* Current uncontrolled body movements such as tics, tremors or seizures,
* Current wound dressings or infections on the chest that might interfere with the PulmoVista 500 electrode belt placement
* Women of child bearing potential whose pregnancy cannot be excluded based on a pregnancy test or other proven facts.
* Allergic to materials used in the electrode belt
* Participation of the patient in an interventional trial within the last four weeks before enrollment in this trial
* Evidence suggesting that the patient or his legal representative is not likely to follow the trial protocol (e.g. lacking compliance)
* Known infectious diseases that require isolation of patient (e.g. MRSA)
* Concomitant use of an air anti-decubitus medical mattress with dynamic inflation that cannot be deactivated during EIT measurements
A RCT Evaluating a Chatbot in Increasing Physical Activity Among Older Adults

This study will compare the efficacy of a Chatbot-delivered stage of changes (SOC)-tailored online intervention (intervention group) versus a Chatbot-delivered non-SOC-tailored online intervention in increasing the prevalence of meeting WHO recommended physical activity level six months after completion of the intervention among inactive community-dwelling individuals aged ≥65 yeas. In the intervention group, the Chatbot will assess participants' physical activity level and SOC regarding PA and automatically deliver interventions tailor to their SOC every week for 12 weeks. In the control group, the Chatbot will not assess participants' SOC. It will assess participants' physical activity level and provides a standard intervention covering general information about physical activity for older adults, which is not tailoring to participants'SOC every week for 12 weeks. All participants will be followed up after completion of the interventions (T1) and six months after T1 (T2).


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥65 years,
* Having a Hong Kong ID,
* Chinese speaking,
* Not meet the WHO recommended level of MVPA
* Willing to be followed by telephone at 3 and 9 months,
* Having a smartphone
* Able to send and read text/voice message via smartphone.
* Willing to wear an accelerometer for a week at T0, T1 and T2.

Exclusion Criteria:

* Blindness or deafness,
* Having been diagnosed with major psychiatric illness (schizophrenia or bipolar disorder) or dementia,
* Score ≥1 in the Chinese version of the Physical Activity Readiness Questionnaire (PAR-Q)
* Score ≤16 in the validated telephone version of the Cantonese Mini-mental State Examination (T-CMMSE)
DCNN Developed for Detection and Assessing the Perfusion of PTG

Since the anatomical location and appearance of the parathyroid gland (PTG) vary, detection of the PTG and preserving the blood supply are among the difficulties encountered during a thyroidectomy procedure. We are planning to train a deep convolutional neural network based on a larger sample of endoscopic images to develop a model to assist surgeons in detection of PTG during endoscopic thyroidectomy. Furthermore, we would like to train a DCNN to predict blood perfusion based on endoscopic images comparing to indocyanine green fluorescence angiography as reference standard, and assess the performance of DCNN in predicting postoperative hypoparathyroidism.

Since the anatomical location and appearance of the parathyroid gland (PTG) vary, detection of the PTG and preserving the blood supply are among the difficulties encountered during a thyroidectomy procedure. Resection of the PTG by mistake or interruption of the blood supply may lead to transient or permanent hypoparathyroidism, which would require short-term or lifelong calcium and/or vitamin D supplement. We are planning to train a deep convolutional neural network based on a larger sample of endoscopic images to develop a model to assist surgeons in detection of PTG during endoscopic thyroidectomy. Although several researchers indicated that indocyanine green fluorescence angiography could be used to assess the perfusion of the PTG intraoperatively, it may cause allergic reaction and need repetitive injection. Therefore, we would like to train a DCNN to predict blood perfusion based on endoscopic images comparing to indocyanine green fluorescence angiography as reference standard, and assess the performance of DCNN in predicting postoperative hypoparathyroidism. This research may lead to the development of endoscopic modules in PTG detection and PTG perfusion prediction to reduce postoperative hypoparathyroidism.

Eligibility Criteria:
Inclusion Criteria:

* The patients who undergo endoscopic thyroidectomy

Exclusion Criteria:

* hyperparathyroidism
* hypoparathyroidism
* neck surgery history
* cervical radiotherapy history
Efficacy Of Autologous Epidermal Cell Suspension And Silver Sulfadiazine Ointment In Burn

Different medical treatments are available for treatment of skin burns such as skin grafts and silver sulfadiazine ointment. These treatments are used for second degree burn as routine technique in burns units. Cell therapy is a new approach for treatment of skin disease.In this study we use autologous epidermal cell suspension to achieve better cosmetic and functional results in treatment of second degree burn.

In this study 20 patients in Burn Department of Sina Hospital Tabriz, with at least 2 areas of second degree burn randomly choose. First skin samples are taken from normal skin by 4mm punch and send to the laboratory for preparation of epidermal cell suspension and this suspension is transferred to the one area of second degree burn in each patient and the other area in the same patient dresses by silver sulfadiazine ointment. The dressing changes are followed up for 12h for first assessment of therapy until 10th day after intervention. In the days of 5, 10, 15 and 20 the percentage of re-epithelization for each treatment will be measured. After 2 months, patients are visited and any complications check for scar formation, pain, post inflammatory hyper-pigmentation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy patient with second degree burn admitted in burn unit

Exclusion Criteria:

* Pregnancy-lactation
* Immunosuppression like receiving chemotherapy or radiotherapy
* Patient unsatisfied to going on study
Particle Size Project

This study is designed to test the effects of chewing efficiency on human gut microbiome composition and function.

Our working hypothesis is that increased chewing will lead to an increase in short-chain fatty acid production We further expect this effect to lead to a detectable decrease in fecal particle size and distinct changes in gut microbial community composition. Here, we will explore this hypothesis using a fixed-order within-subjects study design in a group of healthy participants. Each participant will have one week of normal dietary habits and one week of increased chewing time. We will collect stool samples three times per week in order to measure microbial abundance and metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Above age 18?
* Able to provide stool samples at no risk to yourself?
* Do you have card access to the CIEMAS building (work in CIEMAS, in Pratt School, or undergraduate at Duke), and are you able to visit this building (at times of your own convenience) for the purposes of this study?

Exclusion Criteria:

* Oral antibiotic treatment within the past month?
* Have a history or current diagnosis of irritable bowel syndrome?
* Have a history or current diagnosis of inflammatory bowel disease?
* Have a history or current diagnosis of type 2 diabetes?
* Have a history or current diagnosis of chronic kidney disease with decreased kidney function?
* Have a history or current diagnosis of intestinal obstruction?
* Have a history or current diagnosis of untreated colorectal cancer?
* Have you had a colonoscopy within the past month?
* Had oral antibiotics within the past month?
* Do you consume one entire non-snack meal or more per week in liquid form (smoothie, meal replacement drink, etc.)?
* Do you have any dental issues or other physical limitations that would prevent you from thoroughly chewing your food?
* Do you currently practice any mindfulness or dietary techniques that involve making sure that your food is chewed thoroughly?
Effect of the Pneumoperitoneum on Dynamic Variables Delta PP and PVI During Trendelenburg Position.

Arterial pulse pressure variation induced by mechanical ventilation (ΔPP) is considered one of the best parameter to predict fluid responsiveness in patients under general anaesthesia. Pleth Variability Index (PVI) has been proposed as a less invasive alternative. However, the pneumoperitoneum has been recently seen suggested as a limitation to their interpretation. The aim of this observational study is to compare changes in ΔPP and PVI related to autotransfusion associated with a Trendelenburg manoeuver before and during laparoscopy in patients undergoing elective surgery.


Eligibility Criteria:
* American Society of Anesthesiologists (ASA) score I-II
* scheduled for elective abdominal laparoscopic surgery
* with written informed consent
* more than 18 years
* Body Mass Index \< 40 kg.m-2
* no supraventricular arrhythmias
* no heart failure with ejection fraction \<25 %
* no peripheral vascular
* no severe respiratory disease
* no end stage renal failure (creatinine clearance \<30ml/min).
Evaluation of Cognitive Functions by Cerebral Pulse Oximetry

General and Spinal Anesthesia can be used in geriatric patients in orthopedic surgery. Post-op cognitive dysfunction can be seen in orthopedic surgeries in this group of patients.

In this study, the investigators aimed to compare cognitive functions between spinal and general anesthesia using cerebral and systemic oxygenation, hemodynamic data and pre-op, post-op cognitive function tests.

Cerebral Oximeter is a monitoring application based on the measurement of regional oxygen saturation by transcutaneous route by near infrared spectroscopy technology. With this system that analyzes the intraparenchymal and microcirculation in the frontal cortex, cerebral oxygenation changes caused by possible hypoxemia are followed. Unlike pulse oximeter, it works in non-pulsatile conditions. In other words, continuous, real-time and safe oxygen saturation is continued to be measured even in the case of cardiopulmonary arrest. It is a significant advantage of noninvasive measurement according to jugular venous oxygen saturation measurement. For normal healthy people, the accepted normal range is 58-82%, while 0 to 15% of measurements are important for providing CPR process information.

Oxygen saturation measured by cerebral oximetry is different from that measured by other oxygen saturation measurement techniques. The main reason for this is the technique itself and the region where it is used. The radiation emitted by the cerebral oximetry sensor is aimed at the microvessel structure with venous and arterial mix. Since the contribution of venous and arterial blood volume in this structure is between 70-75% and 30-25%, different results are obtained based on only arterial or just venous bed measurements. In this sense, the measured saturation value is lower than the arterial oxygen and pulse oximetry saturation values; higher than venous values.

The ratio of oxyhemoglobin to the total hemoglobin below the region under evaluation of the system is expressed as, value in% System and reflected to the user as Regional Oxygen Saturation (rSO2). There are publications that can be used not only for cerebral but also for different tissues (ischemic limb, kidney, etc.).

General and Spinal Anesthesia can be used in geriatric patients in orthopedic surgery. Post-op cognitive dysfunction may be seen in orthopedic surgery in this patient group. There are not enough studies showing the correlation of cognitive functions with cerebral pulse oximetry after general and spinal anesthesia. In this study, the investigators aimed to compare cognitive functions between spinal and general anesthesia using cerebral and systemic oxygenation, hemodynamic data and pre-op, post-op cognitive function tests.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2
* patients with lower extremity surgery
* Cognitive functions sufficient

Exclusion Criteria:

* Brain functions affected
* Peri-operative MAP \<60 ones
* Those with electrolyte dysfunctions
* Those who need more blood and blood transfusion
* Patients with ASA 3 and above
Effectiveness of Stabilization Exercise in Youth Basketball Players With Ankle Sprain

Ankle injuries are one of the most common sports injuries. Ankle injuries account for 10% to 30% of all injuries and 5% to 20% of all time-wasting injuries. Athletes involved in sports such as football, basketball, and volleyball are particularly at risk for such injuries, largely due to the running and jumping activities involved. Basketball has one of the highest injury rates of any team sport, with 10 injuries in a 1000 hour period.

The ankle is anatomically strong because of the structure of the bones and ligature that make it. Despite this, ankle injuries are the most common type of injury in sports injuries due to the stress and impact of athletes. It is estimated that 25% of the injuries occurred were ankle injuries. Approximately 85% of ankle injuries are lateral ankle sprain.

In basketball, ankle sprain is the most common type of injury. This is because repeated jumps, landings and sudden changes of direction in the nature of basketball. Due to degeneration in the bond structure as a result of ankle sprained, balance problems are also seen in athletes. Therefore, it is important that athletes evaluate the jump performance. In order to better understand the type and severity of injury of athletes, it is necessary to assess not only the physical characteristics but also the anxiety of physical activity and the relationship between this anxiety and injury, as fear of moving in athletes can develop as physical and psychological maturity is not developed enough during the pub period. The fear of moving can negatively affect the healing phases of the injured athlete, or even delay healing.

Plyometric training has been proven to improve muscle strength and power production. In addition, regular exercise can lead to significant improvements in postural control, jumping, sprinting, diversion speed and agility performance in young basketball players. Fear of re-injury is the fear of being vulnerable to painful re-injury even though physical recovery has been achieved. This situation also has an effect on psychological changes such as movements to protect the muscles, insecurity and focusing problems in the physiologically injured area. Studies show that fear of re-injury also influences muscle activation patterns, influencing muscle recovery, neuromuscular function, and rehabilitation outcomes. As a result, this delays the return to sports.

Eligibility Criteria:
Inclusion Criteria:

Between 14-18 years old Become a licensed male basketball player Playing in the Istanbul League of the Turkish Basketball Federation 5 days a week, more than 1.5 hours a day to train

Exclusion Criteria:

Played a match in the 48 hours before the assessment No lower extremity injury other than ankle
Strong Families Strong Forces: Supporting Active Duty Families With Very Young Children

The purpose of this research is to evaluate the efficacy of the Strong Families Strong Forces Parenting Program compared to a parental self-care (Strong Parents) condition in a sample of 150 Active Duty Families with children ages birth to 5 years.

The overall aim of this research is to adapt and evaluate the efficacy of a parenting program compared to a parental self-care program for Active Duty families. A sample of 150 Active Duty families with young children who have a parent scheduled to deploy in the next six months will be recruited to participate. Families will be assigned either to receive the Strong Families Strong Forces Parenting Program, designed to reduce the impact of deployment separation on parenting stress and co-parenting, or to the Strong Parents Self-Care program, designed to support parents to focus on the importance of self-care throughout the deployment cycle. Investigators will compare the two groups on parenting stress, quality of parent-child relationships, parenting/co-parenting, and family and child well-being.

Eligibility Criteria:
Inclusion Criteria:

* Cohabitating couple with at least one child age birth to 5 years old in which one parent is active duty and is scheduled to deploy within the next 6 months
* Anticipated deployment time must be at least six months and excludes separations due to the Service Member attending a school
* Anticipate that non-deploying parent will remain in the area during the deployment
* Both parents are willing to consent to study participation
* DEERS -eligible
* 18 years or older
* English-speaking
* The parent remaining at home to care for the children anticipates remaining within 30 miles of Fort Hood to be seen in home, otherwise will need to be seen in office
* Anticipate that both parents will remain in the area for at least three months after redeployment to complete intervention and follow-up assessment

Exclusion Criteria:

* Any family member with a significant medical or psychiatric condition requiring a higher level of care than can be provided by the study/comparison protocols
* Active psychosis or mania