cyrilzakka/clinical-trials huggingface dataset:
GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer

This is a phase II, multicenter, open-label study to evaluate the antitumor activity, efficacy and safety of GEN-001 in combination with avelumab as a third line (3L) or greater line treatment which is not received the Standard of Care (SOC) for patients with PD-L1 positive advanced GC/Gastroesophageal Junction Adenocarcinoma who are not received cancer immunotherapy regimens as mono or combination therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed unresectable, recurrent, locally advanced or metastatic GC/Gastroesophageal Junction Adenocarcinoma
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Have adequate organ functions as defined in the protocol
* Negative childbearing potential
* Have experienced documented objective radiographic or clinical disease progression after 2 or above previous lines of standard therapy.
* PD-L1 positive
* Measurable disease as per RECIST v1.1 defined as at least 1 lesion
* Estimated life expectancy of at least 3 months
* Have ability to swallow and retain oral medication and no clinically significant gastrointestinal abnormalities

Exclusion Criteria:

* Previously received T-cell coregulatory protein inhibitors
* Has clinically significant evidence of ascites by physical exam
* Known prior severe hypersensitivity reactions to monoclonal antibodies or any component in their formulation
* Has active autoimmune disease that has required systemic treatment in the past 2 years
* Current use of immunosuppressive medication
* Have an active infection requiring antibiotics, antifungal or antiviral agents or have received a course of antibiotics within 4 weeks
* Has received a live vaccine within 4 weeks
* Known history or any evidence of active for non-infectious pneumonitis
* Prior solid organ or allogeneic stem cell transplantation
* Has had any investigational or anti-tumor treatment within 4 weeks or 5 half-life periods of starting study treatment, had any major surgeries within 4 weeks
* Has received proton pump inhibitors (PPIs) within 2 weeks
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has clinically significant (i.e., active) cardiovascular disease
* Has other persisting toxicities
* Has other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, or psychiatric conditions
Limberg-flap: Prospective Data Collection

The investigators think, that the treatment of pilonidal sinus with excision and covering of the defect with a Limberg-flap is a very good treatment option. The investigators are introducing this treatment for recurrences of this illness in our clinic and want to analyse the feasibility, the results, the complications and the patients opinion after the treatment.

If the results are good, a prospective randomised study is a further option.

1. Patients, that come to our clinic with problems caused by a pilonidal sinus are informed about the different treatment options of the illness.

   * If the patient suffers of a recurrence of the illness, a complete excision, followed by a covering of the defect with a Limberg-flap is recommended.
   * If the patient has the first time problems by a pilonidal sinus, we recommend an open limited excision of the fistulas.
   * In cases with acute infected situation, we first conduct a very limited incision/excision and treat them with antibiotics. The treatments mentioned before are in such cases offered 3 to 4 Weeks after the fist little operation.
2. All Patients, that wish their pilonidal sinus treated with a complete excision followed by a covering of the defect with a Limberg-flap, are asked if they are willing to participate in the observational study.
3. Patients, who gave their informed consent for the operation and the study are included.
4. Preoperative data are recorded.
5. The patients are operated on and intraoperative data (e.g. how big was the flap) are recorded.
6. After 3 Weeks the patients are checked and complications, happiness and duration of the time off work are recorded.
7. After a year the patients are contacted by sending them a postal questionnaire, which they send back to us. Additionally the are contacted by phone. Recurrence, other complications and their opinion concerning the treatment and its consequences are recorded.

Eligibility Criteria:
Inclusion Criteria:

* Recurrence or persistence of a pilonidal sinus
* Elective Limberg-flap operation
* Written informed consent of the patient for the operation and participation of the study

Exclusion Criteria:

* Doubts of the capability of the patient to understand the study or to decide.
Stereotactic Body Proton Therapy for Treatment of Primary Renal Cell Carcinoma

This study examines the impact of proton based stereotactic radiation therapy (SBRT) on kidney function as well as other oncologic outcomes including local control, locoregional and systemic failure, progression free and overall survival.

The incidence of kidney cancer diagnosis has been increasing over the last years. Surgical resection represents the mainstay treatment. However, many patients are deemed unfit for surgery due to medical comorbidities or technical limitations. There are non-surgical options including active surveillance, cryotherapy, microwave ablation, radiofrequency and stereotactic radiation therapy (SBRT). SBRT using conventional x-rays has recently been shown to improve outcomes for patients with primary renal cell carcinoma (RCC) in terms of local control and toxicity. However, this treatment was associated with a significant decline in kidney function that necessitates additional intervention including dialysis in some patients. Proton therapy represents an emerging technique with unique properties that allow the bulk of the proton cancer fighting energy to be released at the tumor (Bragg peak) while sparing nearby healthy tissues and organs, particularly the remaining healthy kidney, ipsilateral kidney, bowels, spine and liver. With this technology, both kidneys, the remaining ipsilateral and contralateral, could be spared and thus less damage is expected. This study aims to study the impact of proton based SBRT on the kidney function.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Biopsy proven renal cell carcinoma.
3. No clinical or radiographic evidence of metastatic disease.
4. Not a candidate for surgical treatment or local ablative procedures.
5. Subjects are able to undergo either an MRI or administration of contrast agent for CT.

Exclusion Criteria:

1. Prior history of radiation treatment with overlapping fields.
2. Patients with proven metastatic disease.
3. Female subjects who are pregnant or planning to become pregnant during the treatment.
Redox Status and Immune Function

In this investigation the investigators utilized N-acetylcysteine (NAC) supplementation to enhance reduced glutathione (GSH) stores during an 8-day recovery period from a strenuous eccentric exercise protocol in order to test the hypotheses: i) redox status perturbations in skeletal muscle are pivotal for the immune responses and ii) antioxidant supplementation may alter immune cell responses following exercise-induced muscle microtrauma.

The major thiol-disulfide couple of GSH and oxidized glutathione (GSSG) is a crucial regulator of the main transcriptional pathways regulating aseptic inflammation and recovery of skeletal muscle following aseptic injury. Antioxidant supplementation may hamper exercise-induced inflammatory responses.

The objective was to examine how thiol-based antioxidant supplementation affects immune mobilization following exercise-induced skeletal muscle microtrauma. In a two-trial, double-blind, crossover, repeated measures design, 10 young men received either placebo or NAC (20 mg/kg/day) immediately after a muscle-damaging exercise protocol (300 eccentric contractions) and for eight consecutive days. Blood sampling and performance assessment were performed pre-exercise, 2h post-exercise and daily for 8 consecutive days.

Eligibility Criteria:
Inclusion Criteria:

* Recreationally trained (VO2max \> 45 ml/kg/min)
* Engaged in regular exercise for ≥3 times/week for \> 12 months
* non-smokers
* Abstain from exercise during the course of the two trials
* No consumption of performance-enhancing substances, antioxidants, caffeine, alcohol and/or medications during the study.

Exclusion Criteria:

* NAC intolerance
* Recent musculoskeletal injuries of the lower limbs
* Febrile illness
* History of muscle lesion.
Foot Bath on Fever Management in Children (EWWFBFMC)

Reducing the dependency on medication in lowering fever, which is one of the most common symptoms in childhood, and developing safer and more feasible alternative methods are important for child health. This study is planned to evaluate the effect of warm water foot baths on vital signs and pain in children and to scientifically examine this effect with a randomized controlled trial.

Fever is one of the most common symptoms in childhood, especially in children under the age of five. While it is the most frequent reason for visits to health institutions, it constitutes 25% of pediatric emergency visits. Lack of knowledge about fever in parents triggers fear, and the thought that it can cause seizures, disability, and brain damage induces anxiety and panic in many families. In the presence of anxiety and panic, families may quickly resort to early and incorrect treatment. Administering less medication than necessary for low fever or high doses for high fever, repeated use of antipyretics, and inappropriate use of antibiotics lead to ineffective management, causing an increase in repeated emergency visits and unnecessary crowding in emergency services. Published guidelines on high fever have emphasized focusing on pain and comfort rather than reducing fever in children. It is reported that foot baths, preferred in pain management, effectively reduce pain and increase comfort. Additionally, guidelines related to fever highlight that warm applications after medication administration can effectively lower persistent fever. Warm water foot bath therapy dilates blood vessels, increases blood circulation, releases heat as sweat, and supports increased oxygenation. Increased circulation improves tissue nutrition and reduces stress. In a study by Ishita et al. (2017), it was observed that body temperature decreased in children who had a warm water foot bath. Similarly, studies by Sunar (2017) and Retnam and Sophia (2018) reported that warm water foot baths were effective in reducing fever in individuals with complaints of high fever.

Eligibility Criteria:
Inclusion Criteria:

* The child is between 1-5 years old. The child has presented to the emergency department with a fever of 38.3°C or higher.

The child is a patient with "Yeşil alan" (specific condition or disease). The child has no chronic illness. The child has not used any other antipyretic medication in the last 6 hours. The child has been administered 15 mg/kg of oral paracetamol as prescribed by the doctor.

The child and their parent(s) have volunteered to participate in the study. Written consent from the parent(s) is obtained.

Exclusion Criteria:

Individuals who have not agreed to participate voluntarily in the study. Children who have been unable to take paracetamol due to spillage or vomiting. Children with compromised skin integrity. Individuals who have undergone surgical procedures that would hinder the child's activity.

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Clinical Validation Study for CPM Device

This study is designed to be a clinical validation study to ready the CPM System for FDA 510(k) submission. This study will be conducted as a prospective non-randomized. The study is non-significant risk since the CPM Device is noninterventional and noninvasive. The study is primarily designed to validate the accuracy of the respiration rate and the changes in relative tidal volume. All participants will be fitted with both the CPM Device as well as reference devices (capnography and ECG). Participants will be randomized between 4 procedures (A-D) which will determine the order of 18 exercises. Each exercise has about 2 minutes of device recording and two minutes of rest. Each exercise contains two positions: sitting up for one minute and lying down for one minute. For some exercises, the participant will be instructed to breathe at a certain rate (assisted by a metronome). For other exercises, the participants will breathe at a normal rate but change how deep the are breathing. For exercise 18, all capnography reference devices will be removed, and an ECG reference device will be placed. After exercise 18, the participant will have all devices removed and the study visit will terminate. The participant will receive a safety follow-up call about 1 week after their visit.


Eligibility Criteria:
Inclusion Criteria:

* Adults over the age of 18 and who are willing and able to give informed consent
* Willing and able to participate in all activities related to this study, including trimming chest hair and wearing a reference device and the CPM wearable device
* Volunteers of any race, any gender
* Range of physiques
* Healthy

Exclusion Criteria:

* Injury or skin disturbance in the area of the test device
* Allergies or sensitivities to silicone/acrylic-based adhesive
* Pregnant, method of assessment at discretion of PI
* Currently smokes cigarettes
* Has known respiratory conditions that might prevent them from following the study procedure such as:

  * Flu
  * Pneumonia/bronchitis
  * Shortness of breath/respiratory distress
  * Respiratory or lung surgery
  * Emphysema, COPD, lung disease
* Has self-reported heart or cardiovascular conditions such as chest pain, AFib, CHF, cardiomyopathy, or other conditions that could interfere with cardiopulmonary function
* Has other self-reported health conditions that could interfere with the breathing patterns and exercises detailed in the protocol (including wearing a capnography mask)
Acromegaly & Sleep Apnoea

Estimates of the prevalence of acromegaly, a condition resulting from excess growth hormone secretion, are as high as 1:1000. If detected late acromegaly increases the risk of joint destruction, heart disease, sleep apnoea, high blood pressure, diabetes, and polyps in the colon. To have a greater effect on long-term outcomes this disease needs to be detected early. By screening a 'high risk' population (sleep apnoea clinic) the investigators may be able to detect these patients earlier and prevent late complications of the disease. At LTHT the referral pathway for new referrals to the sleep apnoea clinic involves initial attendance to pick up a pulse oximeter to wear overnight to measure oxygen levels. These readings show approximately 1:4 patients displays evidence of significant obstructive sleep apnoea to warrant referral to the treatment group for continuous positive airway pressure (CPAP), weight management, and occasionally mandibular adjustment.

Patients attending the sleep apnoea clinic either as new referral or for review will be asked to participate in the proposed study. The study is cross-sectional in design incorporating two sub-populations within the sleep apnoea clinic. The first cohort comprises patients under follow-up known to have sleep apnoea, and the second cohort those patients prospectively attending the sleep apnoea clinic for assessment. If after an explanation of the study they agree to participate blood will be taken for assessment of IGF-I and they will be asked to complete a simple questionnaire.

The aim will to be to screen 1000 consecutive patients. The questionnaire will incorporate five simple questions to be completed with a 'yes' or 'no' answer. Where IGF-I levels are elevated patients will be investigated further for the possibility of acromegaly. The presence of biochemically proven acromegaly will be used to determine if the simple question has sufficient sensitivity to use as a screening tool.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 16 and above.
* Referred to the Sleep Apnoea Clinic for assessment of obstructive sleep apnoea
* Have capacity to given informed consent.

Exclusion Criteria:

* Patients under 16 years of age
* Not referred to the Sleep Apnoea Clinic
* Unable to give informed consent
Effect-site Concentration of Remifentanil for Double-lumen Tubes Intubation: Airtraq VS Macintosh Laryngoscope

The 50% effective concentration of remifentanil by target controlled infusion was not determined for inhibiting the haemodynamic response during double-lumen tube (DLT) intubation. Previous study showed that Airtraq videolaryngoscope provided more stable haemodynamics than Macintosh for double-lumen tube intubation. In this study, the investigators will compare the 50% effective concentration of remifentanil between Airtraq videolaryngoscope and Macintosh laryngoscope for inhibiting haemodynamic responses during DLT intubation.

Dixon "up-and-down" method was used to determine 50% effective concentration of remifentanil by target controlled infusion for inhibiting the haemodynamic responses during DLT intubation with Airtraq videolaryngoscope or Macintosh laryngoscope.

Eligibility Criteria:
Inclusion Criterias:

1. American Society of Anesthesiologists physical status of I-II
2. Patients aged 18-65 years
3. BMI 18-35 kg/m2
4. Elective pulmonary surgery under general anesthesia to double-lumen tubes intubation
5. Mallampati classifications Ⅰ-Ⅱ

Exclusion Criterias:

1. Emergency operation
2. Anticipated difficult airway or history of intubation difficulties
3. Be allergic to any of the drugs used in the experiment, or have a history of drug allergy
4. Preoperative use of analgesic, sedative and other drugs
5. Uncontrolled hypertension and heart disease
6. Have a history of heavy smoking and alcohol abuse, serious drug abuse, and severe systemic infections
7. There are severe mental and nervous system symptoms, and patients cannot cooperate with the study, such as language comprehension disorder, mental illness, etc
8. Other clinical trials were conducted within 3 months prior to inclusion in the study
Water Load Test Value for Hyponatremia

Acute water load test has been using to diagnose renal ability to excrete water for decades. Latest recommendations for the diagnosis of hyponatremia do not recommend performing such a test. The investigators aim at, retrospectively, study the value of acute water load test in patients suffering from a syndrome of inappropriate antidiuresis.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old at the time of the test
* affiliated to a social insurance system
* water load test performed at the Renal and Metabolic Diseases Unit of the European George Pompidou Hospital, AP-HP, Paris, France
* between 01/01/2001 and 12/31/2019

Exclusion Criteria:

* hypernatremia and/or polyuria-polydipsia (diabetes insipidus)
* hyponatremia due to a tea and toast syndrome and/or a beer potomania
* hyponatremia due to a high (or normal) osmolality related to diabetes mellitus, hyperproteinemia and/or intoxication
* chronic kidney disease with an estimated glomerular filtration rate (eGFR) by the MDRD formula \<60 mL/min/1.73m2
* hyponatremia related to thiazides
* hyponatremia related to an hypovolemic status
* syndrome of inappropriate antidiuresis related to an endocrine disorder (such as hypothyroidism or adrenal insufficiency)
Prediction of Chronic Pain by the Pain Monitor

The skin conductance algesimeter (Pain Monitor™, Med-Storm Innovation AS, NO-0264 Oslo, Norway)) reflects the sympathetic nervous system by the measurement of the skin conductance of the palm of the hand. SCA detects nociceptive pain fast and continuously, specific to the individual, with higher sensitivity and specificity than other available objective methods.

The skin conductance response to a calibrated noxious stimulus varies among patients. It defines two types of people depending on its magnitude.

The investigators assume that the importance of skin conductance response to a noxious stimulus predicts the occurrence of chronic pain in patients operated by thoracotomy.


Eligibility Criteria:
Inclusion Criteria:

* adult patients of both sexes
* planned pulmonary resection for cancer performed by a posterolateral thoracotomy
* thoracic epidural analgesia

Exclusion Criteria:

* pregnancy,
* morbid obesity,
* insulin-dependent diabetes with dysautonomia,
* inability to proceed with anesthesia using the BIS signal,
* known allergy to remifentanil, propofol, atracurium or to levobupivacaine,
* contra-indication to nefopam
* contra-indication to ketoprofen
Randomized Control Study of Dermal Staples vs Subcuticular Sutures on Postoperative Scar After Thyroidectomy

In this study, a randomized controlled study was conducted between two groups of 20 classic recipients of intradermal sutures and 20 recipients of intradermal staple methods for patients undergoing the same cervical incision. This is a study to see if there is any difference in pain and esthetics in scar formation of these groups.


Eligibility Criteria:
Inclusion Criteria:

* Patient who will have thyroid surgery

Exclusion Criteria:

1. done thyroid surgery before
2. done any radiotherapy on neck
3. who needs neck dissection
4. laparoscopic ot robotic surgery
5. under 18 years old or over 70 years old
6. bad general condition, high American Society of Anesthesiologists (ASA) score (over 3)
7. who used immunosuppressive drugs in 6 months
8. breast feeder or pregnancy
9. who disagrees to do this trial
Portsmouth CORE-D Routine Care Data Repository

An integrated database of depersonalised routine hospital patient data consisting of demographic and disease attributes, physiological or laboratory measurements, care contacts and interventions along with associated clinical outcomes. The database is an essential resource for the development and testing of risk models and classification systems, modified as necessary for patient subgroups, which can then be introduced into clinical care to improve patient outcomes. It can also be used for large scale simulations to evaluate interventions.

The aims and objectives of this database of depersonalised routinely collected hospital patient data are to:

* Conduct epidemiological and observational studies of acute hospital care.
* Develop and use algorithms and risk models to identify the deteriorating / sick adult so that interventions and enhanced care can be provided in a timelier manner with consequent resource and outcome improvements. This covers both the deteriorating inpatient at risk of adverse outcomes and people in the local community at risk of hospitalisation or in need of other health services.
* Retrospectively evaluate interventions e.g. impact of system-wide clinical pathway introduction
* Conduct simulations of clinical pathways

Eligibility Criteria:
Inclusion Criteria:

* Adult presenting at the acute hospital or receiving services from the hospital

Exclusion Criteria:

* Adults who have registered an opt out of research with National Health Service (NHS) Digital
* Adults who have contacted the hospital to ask that their records are not to be included in this study