cyrilzakka/clinical-trials huggingface dataset:
Trial of Neoadjuvant Intensity-Modulated Radiation Therapy Followed by Surgery and Intraoperative Radiation Therapy in Resectable Retroperitoneal Soft Tissue Sarcoma (RETRO-WTS)

Local control rates in patients with retroperitoneal soft tissue sarcoma (RSTS) remain disappointing even after gross total resection, mainly because wide margins are not achievable in the majority of patients. In contrast to extremity sarcoma, postoperative radiation therapy (RT) has shown limited efficacy due to its limitations in achievable dose and coverage. Although Intraoperative Radiation Therapy (IORT) has been introduced in some centers to overcome these dose limitations and resulted in improved outcome, local failure rates are still high even if considerable treatment related toxicity is accepted. As postoperative administration of RT has some general disadvantages, neoadjuvant approaches could offer benefits in terms of dose escalation, target coverage and reduction of toxicity, especially if highly conformal techniques like intensity-modulated radiation therapy (IMRT) are considered.

Therefore the RETROWTS trials has been designed as a prospective, one armed, single center phase I/II study investigating a combination of neoadjuvant dose-escalated IMRT (50-56 Gy) followed by surgery and IORT (10-12 Gy) in patients with at least marginally resectable RSTS. The primary objective is the local control rate after five years. Secondary endpoints are progression-free and overall survival, acute and late toxicity, surgical resectability and patterns of failure. The aim of accrual is 37 patients in the per-protocol population.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* histologically confirmed, primary or locally recurrent soft tissue sarcoma of the retroperitoneal space
* judged as at least marginally resectable
* absence of distant metastases
* tumor size ≥ 5 cm

Exclusion Criteria:

* missing written informed consent
* missing histological confirmation of soft tissue sarcoma
* Desmoid tumor (syn. aggressive fibromatosis)
* judged as gross incomplete or not resectable
* incomplete staging
* presence of distant metastases
* prior radiation therapy to the abdominal region
* participation in another clinical interventional study
* inflammatory bowel disease
Satiation Study With Children Attending a Tertiary Feeding Clinic

This is a pilot study of children attending the Glasgow feeding clinic (GFC) which looks after children with severe feeding problems who commonly have low appetite and extreme thinness. The investigators want to find out if thin children respond to food in the same way, using an established method to assess energy compensation.

Thinness occurs as a result of undereating, but it is not always clear why an individual child has not eaten enough, or how to get them to eat more. There is a need to understand the child characteristics that predispose to undereating and the how these operate, in order to design more effective treatment and prevention programmes. The Glasgow feeding clinic (GFC) looks after a range of children with severe feeding problems who commonly have low appetite and extreme thinness.

A Ghanaian student will come to Glasgow, funded by the Glasgow University /Scottish funding council Global Challenges Research fund, to learn these techniques to use in future PhD research. The student will conduct a pilot study of children attending the GFC. The student will invite 40 families to complete our standardised online questionnaire (ICFET) about their child's eating behaviour and collate existing growth measurements as well as their feeding history.

A standardised energy compensation study will then be undertaken in 20 of the thinnest children. At two visits at least a week apart, the children will be given one of two similar tasting drinks in random order, one with very few calories and another with extra, without them knowing which is which. After 30 minutes they will eat as much as they want of a standardized lunch. All foods and drinks offered will be weighed before and after, to calculate the amount of energy eaten in total after the low energy drink, compared to the high energy drink.

Eligibility Criteria:
Inclusion Criteria:

* Currently attending Glasgow Feeding Clinic or seen within the last 2 years.
* Completed ICFET questionnaire and eating solid food at least weekly.
* Body mass index \< 9th centile.
* Within 40 minutes car travel from study centre

Exclusion Criteria:

* Patient or family member shielding from COVID.
* Not able to swallow safely
* Not taking solid foods
* Fully tube fed: i.e. receiving more than 75% of energy requirements from tube feeding.

No measurements
Device Assisted Full Thickness Resection Versus Endoscopic Submucosal Dissection for Duodenal Neuroendocrine Tumors

Introduction :

The incidence of duodenal neuroendocrine tumors (DNETs) is increasing. Endoscopic resection is recommended for the management of small DNETs measuring ≤10 mm. Various endoscopic techniques have been utilized for the resection of DNETs including endoscopic mucosal resection (EMR), band ligation assisted EMR, endoscopic submucosal dissection (ESD). However, the published studies report a high rate of histologically incomplete resection even with ESD. More recently, device assisted endoscopic full thickness resection (EFTR) has emerged as a safe and effective resection modality in cases with upper and lower gastrointestinal (GI) mucosal as well as submucosal lesions. There is limited data on the outcomes of EFTR in cases with DNETs.

In this study, we aim to compare the rate of histologically complete resection (R0) with ESD and EFTR in cases with DNETs.

Primary objective:

Rate of R0 resection in both the groups

Secondary outcomes:

1. Technical success: defined as en-bloc resection of the lesion without any residual lesion endoscopically
2. Procedure duration
3. Adverse Events

Inclusion criteria:

1. Adult patients (≥18 years) with biopsy proven duodenal neuroendocrine tumors (DNETs)
2. Size of the lesion \<15 mm
3. Absence of local and distant metastases (EUS and DOTANOC scan)
4. Willing to provide informed consent

Exclusion criteria:

1. Large lesions \>15 mm
2. Invasion of muscularis layer and beyond on imaging (EUS)
3. Scarring or deformity in duodenum
4. Active duodenal ulcer
5. History of prior resection
6. Coagulopathy

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (≥18 years) with biopsy proven duodenal neuroendocrine tumors (DNETs)
2. Size of the lesion \<15 mm
3. Absence of local and distant metastases (EUS and DOTANOC scan)
4. Willing to provide informed consent

Exclusion Criteria:

1. Large lesions \>15 mm
2. Invasion of muscularis layer and beyond on imaging (EUS)
3. Scarring or deformity in duodenum
4. Active duodenal ulcer
5. History of prior resection
6. Coagulopathy
Simvastatin in Aneurysmal Subarachnoid Haemorrhage (STASH) a Multicentre Randomised Controlled Clinical Trial

Intracranial bleeding from ruptured blood vessels (called a subarachnoid haemorrhage -SAH) affects 7000 patients each year in the UK and is a source of considerable death and disability, even in young adults. Recent observations indicate that these bleeds can cause reduced cerebral blood flow which leads to a bad outcome. High rates of death and disability occur, and are particularly prevalent when low cerebral blood flow results in stroke. Prevention of cerebral artery spasm and improvement in blood vessel reflexes are the target of modern therapy. Candidate drugs include statins which have an impeccable safety record and multiple potential beneficial actions (improve cerebral blood flow, reduce inflammatory processes, reduce adverse blood coagulation) following SAH.

The investigators plan to use a statin, Simvastatin (40 mg) to improve cerebral blood flow and reduce inflammation. We have already completed a phase 11 study (n=80) which demonstrated potential benefits for acute statin therapy following SAH, and the investigators now wish to conduct a multi-centre phase 111 study to explore any potential clinical benefits in a larger population (n=1600). The purpose is to see whether the positive effects of statins seen in our phase II study translate into clinical benefits - both short term (e.g. reduced need for intensive care) and long term (outcome and wellbeing at 6 months).


Eligibility Criteria:
Inclusion Criteria

* Patients (age 18 - 65 yr) in which the admitting neurosurgeon has confirmatory evidence of an aneurysm, either by CT angiography, MR angiography or DSA.
* Any clinical grade accepted provided a reasonable prospect of survival.
* Delay to randomisation and initiation of trial medication from the time of the presenting ictus does not exceed 96 hours.

Exclusion Criteria

* Unsalvageable patients:Fixed and dilated pupils after resuscitation, and/or a devastating scan, which precludes definitive therapy.
* Already taking statin therapy.
* Those taking Warfarin - type drugs.
* Pregnancy.
* Known renal or hepatic impairment
* Suspected or known additional disease process, which threatens life expectancy (e.g.malignancy).
* Known or strong suspicion of drug abuse, alcoholism, or those who are unlikely to be amenable to 6 month follow up.
* Those already taking amiodarone, verapamil or potent CYP3A4 inhibitors.
To Study the Individual Variants of Chemotherapy-Induced Neurotoxicity

To study the risk prediction of chemotherapy-induced peripheral neuropathy (CIPN) by the clinical bioinformatics and genomic profile.

This is a prospective, observational, cohort study, monitoring the chemotherapy-induced peripheral neurotoxicity by traditional clinical scales, neurological examinations, and semi-quantitative assessments. Moreover, all the genetic changes will be analyzed by next generation sequencing and we will try to identify relevant variants in individuals who suffer from chemotherapy-induced neurotoxicity.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed epithelial ovarian cancer, endometrial cancer or adenocarcinoma of colon or rectum
2. Pathological stage I\~IV for ovarian cancer, stage II\~IV endometrial cancer or stage III \& high risk stage II for colorectal cancer
3. Scheduled to receive adjuvant Paclitaxel/Carboplatin for ovarian or endometrial cancer, or mFOLFOX6 for colorectal cancer
4. Age ≥ 20 years old
5. ECOG Performance status 0-1
6. Adequate organ function

   Bone marrow:

   Absolute neutrophil count (ANC) ≥ 1.5 x 109/L WBC ≥ 3.0 x 109/L Platelet count ≥ 100 x 109/L Hemoglobin ≥ 9 g/dL

   Hepatic:

   Total bilirubin level ≤ 1.0 x UNL AST and ALT ≤ 3.0 x UNL

   Renal:

   Creatinine level ≤ 1.5 mg/dL in men, ≤1.4 mg/dL in women; or Estimated CCr ≥ 60 mL/min (CCr is estimated by Cockcroft-Gault formula, as appendix III).
7. Negative pregnancy test for women of childbearing potential only
8. Patient willing to provide blood sample for research purposes
9. Written informed consent

Exclusion Criteria:

1. Prior treatment with neurotoxic chemotherapy, such as oxaliplatin, cisplatin, carboplatin, taxanes or vinca alkaloids
2. Receiving chemotherapy within 6 months
3. History of allergy to 5-FU or LV
4. Pre-existing peripheral neuropathy of any grade
5. A family history of a genetic or familial neuropathy
6. Active uncontrolled infection
7. Significant medical diseases, such as unstable angina, acute or recent myocardial infarction (\<6 months before enrollment), COPD with frequent exacerbation, uncontrolled hypertension, ore cent CVA (\<6 months before enrollment)
8. Poor compliance
To Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety Between ID1801 and ID1803 in Healthy Male Adults

This study is designated to evaluate the pharmacokinetic interactions of valsartan, amlodipine besylate, rosuvastatin, and ezetimibe in healthy male volunteers.

An Open-label, Single or Multiple-dose, Fixed-sequence, 3-treatment, 3-Period phase 1 study to Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety between ID1801 and ID1803 in Healthy Male Subjects

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male volunteers aged 19 to 45 years
* Subjects who have over 50kg and BMI more than 18.5kg/m2 and less than 29.9kg/m2
* Males must be agree to practice a medically acceptable method\* of birth control and will not donate sperm during the study.
* Subjects who provided written informed consent to participate in this study and voluntarily taken part in during the entire study period

Exclusion Criteria:

* Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
* Subject with symptoms of acute disease within 28days prior to study medication dosing
* Medical history or evidence that can affect absorption, distribution, metabolism and excretion of a given drug
* Drugs or other drugs (aspirin, antibiotics, etc.) that contain the following drug categories or components of the same strain have an overactive or clinically significant history of hypersensitivity:
* Subject with a history of drug abuse or urinalysis positive
* Subject with clinically significant active chronic disease
* Subject with genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
* Genetic myopathic disorder or related family history
* Positive test results for HBs Ab, HCV Ab, Anti HIV(AIDS), RPR Ab
* Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug)
* Subject who cannot take standard meal in hospitalization
* Present history of hypothyroidism or clinically significant assay
* Subjects who donated whole blood or partial blood within 2 or 1 month, respectively, prior to the first administration.
* Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing
* Smokers whose average daily smoking amount exceeds 10 cigarettes per day within 3 months before the first dosing day and those who can't quit from 48 hours before dosing to the time of the last blood sampling.
* Subjects who judged ineligible by the investigator
Seminal Fluid's Changes Over 20 Years

This is a cohort study including all the first seminal exams performed at the Fertility Center, Humanitas Research Hospital (Rozzano, Milan) between January 1998 and December 2018.

The objective of this study is to evaluate retrospectively different changes of TPMSC during last 20 years in male population who underwent a seminal exam in our Center

Eligibility Criteria:
Inclusion Criteria:

* male over 18 years old

Exclusion Criteria:

* error in birth or exam date or age under 18,
* abstinence days \< 3 or \> 6, volume missing o \> 10 ml,
* spermatozoa number/ ml missing o \>220 x106,
* normal forms missing,
* progressive motility missing
A Study of YZJ-4729 Tartrate Injection for the Treatment of Pain After Abdominal Surgery

The primary objective is to evaluate the analgesic efficacy and safety of IV YZJ-4729 Tartrate Injection in patients with acute postoperative pain following abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Be able to understand the study purpose and cooperate with the study procedures of this trial, voluntarily provide written informed consent
2. Body mass index (BMI) ≥18 kg/m2 and ≤28 kg/m2.
3. ASA I - II
4. Experiences a pain intensity rating of moderate to severe acute pain following abdominal surgery, with a pain intensity score of ≥4 on a Numeric Rating Scale (NRS) within 4 hours post-surgery

Exclusion Criteria:

1. Allergy to opioids and other medications that may be used during the trial.
2. Nervous system disorders (e.g. epilepsy)
3. Psychiatric disorders (e.g. depression)
4. History of difficult airways
5. Random blood glucose ≥11.1 mmol/L
6. Uncontrolled blood pressure \[e.g., hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg)，or hypotension(systolic blood pressure \<90 mmHg)\]
7. Abnormal pulse oxygen saturation (SpO2 \<90 %)
8. Abnormal liver function or renal function
9. Used agents that could affect the analgesic response
10. Used agents that could affect drug metabolism
11. Has previously participated in another YZJ-4729 clinical study
Dual Tasking and Upper Extremity Disability in Adolescent Idiopathic Scoliosis

The goal of this observational study is to evaluate the dual task and upper extremity disability in individuals with adolescent idiopathic scoliosis compared to healthy controls and to examine their relationship with clinical and radiological parameters in adolescent idiopathic scoliosis (AIS). The main questions it aims to answer are:

1. To compare dual task and upper extremity disability in individuals with AIS and healthy sex and age-matched healthy controls.
2. To analyze the relationship of dual-task and upper extremity disability in individuals with AIS with clinical and radiological parameters All participants' dual-task performance will be evaluated and they will answer the upper extremity disability survey. Besides, the study groups will be examined thoroughly and radiological parameters will be calculated to identify the clinical and radiological parameters that affect dual-task performance and upper extremity disability.

Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformity and sagittal plane changes are accompanied by coronal plane changes. As a result of spinal deformity, morphological changes occur in the trunk and rib cage, and the relationships between body parts are affected. Considering the anatomical proximity between the scapula and the rib cage, alteration of the shoulder and upper extremity functions as a consequence of the change in proximal orientation is expected.

On the other hand, maintaining postural control depends on the dynamic relationship between sensory information and motor output. Dual tasking is an experience-based neurophysiological process that requires a person to perform two tasks simultaneously. When a person has problems with the neurophysiological process, the performance of one or both functions is negatively affected.

This observational study aims to evaluate the dual task and upper extremity disability in individuals with adolescent idiopathic scoliosis compared to healthy controls and to examine their relationship with clinical and radiological parameters in AIS. All participants' dual-task performance will be evaluated and they will answer the upper extremity disability survey. Besides, the study groups will be examined thoroughly and radiological parameters will be calculated to identify the clinical and radiological parameters that affect dual-task performance and upper extremity disability.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Adolescent Idiopathic Scoliosis

Exclusion Criteria:

* Patients with complaints of neck, back, and shoulder pain
* Having a known neurological or systemic disease
* Having cognitive dysfunction that cannot cooperate with evaluations
* Having undergone musculoskeletal surgery or injury
* Extremity length difference of more than 1 cm
* Regular repetitive overhead shoulder movements related to professional or sports activities
* BMI \>30 kg/m2
Partial Chest Wall Radiation Therapy After Surgery for Lymph Node Negative Breast Cancer

The standard treatment for breast cancer when cancer cells were found near or within the margins of the tissue that is removed during breast surgery, is radiation of the entire chest wall. This may be considered overtreatment since the only reason for doing so is that cancer cells were near or in the margins of the breast tissue that was removed. In this study, the amount of radiation treatment will be limited to the area where the remaining cancer cells were found after surgery.

The purpose of this study is to find out if partial chest wall radiation therapy is as good as whole chest wall radiation therapy in reducing the risk of breast cancer cancer coming back.


Eligibility Criteria:
Inclusion Criteria:

* DCIS or stage T1 or T2 invasive breast cancer, lymph node negative
* Must have undergone mastectomy
* Presence of cancer cells on or close to surgical margins
* Negative pregnancy test for women
* Must receive radiation at Stony Brook University Hospital

Exclusion Criteria

- Received prior radiation to are to be irradiated
Facilitated Tucking Position and Reiki Efficacy in Orogastric Tube Insertion

The aim of this study is to determine the effects of faciliated tucking and reiki given manually during orogastric tube insertion in preterm infants treated in the NICU on stress, pain and physiological parameter (heartbeat, blood pressure, SpO2 and respiratory rate) levels.

Regardless of the severity and duration, preterm infants give physiological and behavioral responses to a painful application. While infants show behavioral responses such as crying, changes in facial expressions, acceleration or deceleration in motor movements during painful interventions, they may subjectively show changes in physiological parameters such as heart rate, respiratory rate, blood pressure, and decrease in saturation value. Because preterm infants are sensitive to many stress factors and due to reasons such as separation from the mother during the treatment process, environments with excessive light, sound and temperature changes, and the absence of a single caregiver. They do not yet have the physiological maturity to cope with painful interventions. This randomized controlled trial was planned to determine the changes in stress, pain, and physiological parameters of faciliated tucking and reiki administered during orogastric tube insertion in preterm infants 32-37 weeks of gestation.

Eligibility Criteria:
Inclusion Criteria:

* 32-37 Gestational weeks,
* From the postnatal 3rd day,
* Feeding with orogastric tube
* Apgar \>5

Exclusion Criteria:

* Premature infants with congenital anomaly, malformation
* Premature infants on mechanical ventilator
* Premature infants receiving sedation