cyrilzakka/clinical-trials huggingface dataset:
Study of 18F-Florastamin PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer

In this study, 18F-Florastamin PET/CT will be performed in patients with suspected recurrence of prostate cancer, to assess the diagnostic performance and safety of 18F-Florastamin PET/CT imaging.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects fully understood the content, process, and potential risks of the study and voluntarily signed an informed consent form (ICF).
2. Male ≥ 18 years of age.
3. Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy.
4. Suspected recurrence or distant metastasis of prostate cancer based on any of the following conditions:

   1. At least 6 weeks after radical prostatectomy (RP): PSA ≥0.2 ng/mL followed by a subsequent confirmatory PSA value ≥0.2 ng/mL.; or
   2. Post-radiation therapy, after radical radiotherapy (or cryoablation therapy): Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir .
5. Subjects who are willing to undergo biopsy, salvage surgery, or radiation therapy based on the researcher's clinical judgment;
6. ECOG score 0 or 2.
7. Subjects who meet the following conditions in hematology, renal function, and liver function:

   Platelet count\>50 \* 10\^9/L Urea/urea nitrogen and creatinine\<1.5 times upper limits of normal AST and ALT\<2.5 times upper limits of normal.
8. Expected survival time ≥ 6 months.
9. Subjects and their partners must use effective contraceptive measurements and avoid sperm donation from the date of signing ICF to 3 months after administration.

Exclusion Criteria:

1. Subjects who have participated in other interventional clinical trials before signing ICF and were within the 5 half-lives of the investigational drug, or who are currently participating in other interventional clinical trials or have participated in clinical trials of radioactive drugs before signing ICF and have been discontinued for less than 3 months until the signing date of ICF.
2. Intravenous injection of iodinated contrast medium within 24 hours, or any high-density oral contrast medium (Such as barium sulfate. Oral water contrast is acceptable, such as compound meglumine diatrizoate oral liquid) within 5 days, prior to study drug administration.
3. Subjects administered any high energy (\>300 KeV) gamma-emitting radioisotope within five physical half-lives prior to study drug administration.
4. If previously taking ADT, it should have been discontinued at least 16 weeks prior to study drug administration.
5. The investigator determines that there are any medical diseases or other conditions that affect the safety or compliance of the subjects.
Digitally Captured Activity Data and PROs to Monitor Physical Function in Prostate Cancer Patients

Prospective observational research study to evaluate the role of wearable activity monitors to predict physical function decline among prostate cancer survivors receiving ADT.

Physical function is a known predictor of QOL in advanced prostate cancer patients and key measure of treatment tolerability. While treatment with Androgen Deprivation Therapy (ADT) improves survival, it is associated with significant toxicities that lead to physical function (PF) decline. The average age of incident prostate cancer is 66 years, and in this older group of men, chronic comorbid conditions often co-occur with diagnosis, further adding to the risk for PF decline. With over 2.9 million prostate cancer survivors in the US, there is an increasing demand for adequate symptom monitoring and PF assessment throughout cancer care. However, there are currently no validated methods to systematically evaluate and predict PF decline. Thus, the overarching objective of this proposal is to determine whether the use of wearable technology to monitor objective daily activity combined with routine symptom reporting can predict PF decline. To accomplish this, we propose a mixed-methods approach that will provide quantitative information to help identify PC survivors at higher risk for PF decline as well as a qualitative aim gain a deeper understanding of the perceived relationships that PC survivors have with their physical activity levels and treatment symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer patients receiving ADT (+/- radiation) or planning to receive ADT. Start date of ADT must be planned for no more 7 days after baseline, or patients must have started ADT within 6 months prior to enrollment.
* 18 years or older
* Ambulatory (use of walking aids, such as cane and rollator, is acceptable)
* Access to a device that has the capability to sync to the Fitbit
* Have an understanding, ability, and willingness to fully comply with study procedures and restrictions
* English or Spanish speaking
* Informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Using a pacemaker, implantable cardiac defibrillator, neurostimulator, implantable hearing aids, cochlear implants, or other electronic medical equipment. However, removable hearing aids are permitted.
Abdominal Versus Vaginal Bisection in Laparoscopic Hysterectomy

Large uteri present a challenge during Total lap.hysterectomy and its extraction is another challenge. This study addressees and compare 2 methods of retrieval of large uteri

Despite a number of publications about TLH for large uterus, few surgeons have compared the results of their technique of TLH through the vagina or abdominal bisection. The aim of this study was to compare the clinical results of TLH for large uterus through transvaginal or abdominal bisection approaches after strict preoperative assessment.

Eligibility Criteria:
Inclusion Criteria:

* large uterus ≥ 12weeks,
* benign pathology,
* mobile uterus
* BMI less than 30kg/m2

Exclusion Criteria:

* unfit for laparoscopy,
* Extensive pelvic adhesions,
* Extensive endometriosis
* malignancy
* virgin cases
Use of USG in Difficult Airway in Obese

Introduction and Purpose: Obesity is an increasing public health problem all over the world. Obesity is a proinflammatory multisystemic disease defined as hypertrophy and/or hyperplasia of adipose tissue. Obesity is frequently encountered in elective and emergency surgical procedures and causes more difficulties in airway management. Difficult airway, characterized by difficult mask ventilation and difficult intubation, is especially common in obese and morbidly obese patients. Some studies show that the measurement of anterior neck soft tissue thickness at the level of the vocal cords plays an important role in estimating difficult laryngoscopy in obese patients. Difficult intubation is envisaged in patients with pretracheal soft tissue thickness of 28 mm and neck circumference of more than 50 cm at the level of the vocal cord.

In this prospective observational study, it is aimed to measure the preoperative anterior cervical soft tissue thickness with 3 parameters by USG in obese patients undergoing elective surgery, and to evaluate the relationship of these values with the Han Scale and Cormack-Lehane classification and their effectiveness as an indicator of difficult airway.

Materials and Methods: 157 patients who will undergo elective surgery under general anesthesia, ages between 18-80, BMI ≥ 30 kg/m2, ASA I-II were included in the study. During the preoperative evaluation, patients' gender, age, height, weight, type of surgery, BMI, neck circumference, thyromental distance (TMM), sternomental distance (SMM), hyomental distance (HMM), neck extension, mouth opening and distance between incisors were measured and tooth structure was evaluated. OSAS was evaluated based on the ASA physical condition score and AHI. Mallampati Classification was recorded. Upper lip bite test was performed. Ultrasonographic measurements were made with the patient in the supine position and the head and neck in a neutral position. The Han Scale was used to evaluate difficult mask ventilation. The laryngoscopy image was evaluated and recorded with the Cormack-Lehane Classification, and ≥2b was accepted as difficult laryngoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Elective surgery, ages between 18-80 BMI over 30, ASA I-II

Exclusion Criteria:

* Facial and cervical trauma, head and neck malignancy, tracheostomy and thyroid surgery, non-cooperate patients, parturients, difficult airway history.
Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease

The study is intended to characterize the lung function profile of BI1744 in COPD patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.


Eligibility Criteria:
Inclusion Criteria:

* Patients willing to participate with confirmed diagnosis of COPD
* 40 years of age or older
* having a 10 pack year smoking history
* able to perform serial pulmonary function tests
* able to use both a DPI and Respimat device

Exclusion Criteria:

* Significant other disease
* clinically relevant abnormal hematology, chemistry, or urinalysis
* history of asthma
* diagnosis of thyrotoxicosis
* paroxysmal tachycardia related to beta agonists
* history of MI within 1 year, cardiac arrhythmia, hospitalization for heart failure within 1 year
* active tuberculosis, cystic fibrosis, clinically evident bronchiectasis
* significant alcohol or drug use
* pulmonary resection
* taking oral beta adrenergics
* taking unstable oral steroids
* daytime oxygen
* enrolled in rehabilitation program
* enrolled in another study or taking investigational products
* pregnant or nursing women, women of child bearing potential not willing to use two methods of birth control
* those who are not willing to comply with pulmonary medication washouts
Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer

The purpose of the trial was to evaluate the safety and efficacy of degarelix when comparing six different doses. The patients participating in the trial were treated with degarelix every month for a year. During the treatment the patients had to visit the clinic for investigations. Blood samples for testosterone, dihydrotestosterone, luteinizing hormone, follicle stimulating hormone, and Prostate Specific Antigen were taken and analysed throughout the trial.

Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent prior to any study related procedures
* Proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy, but including patients with a rising PSA further to prostatectomy or radiotherapy
* ECOG score to be equal to or above 2
* Testosterone level within age-specific normal range
* PSA value equal to or above 2 ng/ml
* Life expectancy of at least 6 months

Exclusion Criteria:

* Previous or current hormonal treatment of prostate cancer
* Recent or current treatment with any drugs modifying the testosterone level
* Candidate for curative treatment such as prostatectomy or radiotherapy
* History of severe asthma, anaphylactic reactions, angioedema, angioneurotic oedema or Quincke's Oedema
* Hypersensitivity towards any component of degarelix or mannitol
* Cancer disease within the last 5 years except for prostate cancer and some skin cancers
* Signs of liver impairment shown as elevated serum ALT or serum bilirubin
* Known hepatic disease
* Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
* Clinically significant disorder including excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
* Mental incapacity or language barrier precluding adequate understanding or cooperation
* Having received an investigational product within the last 12 weeks preceding the trial
* Previous participation in this trial
NAC +taVNS in IDM Who Are Poor Oral Feeders

Infants of diabetic mothers who are failing to learn oral feeding by term age equivalence have greater CNS oxidative stress, which interact to predict poor neuroplasticity response to transcutaneous vagus nerve stimulation paired with oral feeding. We propose treating the oxidative stress in IDM infants prior to initiating taVNS, with an FDA-approved antioxidant (N-acetylcysteine, NAC) to improve CNS oxidative stress, which in turn regulates expression of many genes including BDNF, that may enhance motor learning.

Our group has recently conducted a first-in-infants pilot trial of pairing transcutaneous auricular vagus nerve stimulation (taVNS) with feeding to assist learning oromotor skills. We are enrolling preterm and HIE infants who are failing to learn oral feeds and clinically determined to need a G-tube. In preliminary data, taVNS paired with one or two daily feedings for 2 weeks resulted in 50% of infants attaining full feeds and avoiding G-tube.

A notable number of non-responders were infants of diabetic mothers (IDM) exposed to poor glucose control during pregnancy, all of whom required a G-tube. Uncontrolled maternal hyperglycemia is associated with increased systemic and neuro-inflammation, CNS oxidative stress, DNA damage, and worse neonatal outcomes compared to infants of euglycemic mothers. In neonatal animal models, hyperglycemia has been shown to decrease BDNF, alter long-term synaptogenesis and hippocampal neurochemistry, with ongoing CNS oxidative stress and inhibition of the cortical neuronal plasticity required for learning. In our pilot trial of taVNS-paired feeding, CNS glutathione concentrations (GSH), a MR spectroscopy (MRS) marker of oxidative stress, had significant interaction with IDM in predicting outcome, strongly suggesting that ongoing CNS oxidative stress contributes to neuropathology in IDMs failing oral feeding.

NAC is an FDA-approved antioxidant that is safe and crosses the blood brain barrier, increasing CNS GSH. NAC reduces CNS oxidative stress, enhances learning and provides a neuroprotective effect after brain injury in our and others neonatal HI and neuroinflammatory animal models. Both GSH and BDNF enhance neuroplasticity. Therefore, we hypothesize that pre-treatment with NAC in IDMs who are failing oral feeding, followed by taVNS-paired feeding, will decrease oxidative stress induced by maternal hyperglycemia and IDM-associated brain injury, and increase response to taVNS-paired feeding rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Infants of diabetic mothers who are failing oral feeding, \>39weeks gestation at enrollment, who are clinically stable, on minimal respiratory support (nasal cannula or room air), and clinical team has determined are G-tube candidates

Exclusion Criteria:

* Unstable infants or those requiring positive pressure respiratory support
* Infants \<39 weeks gestation at enrollment
* Major unrepaired congenital anomalies or anomalies that limit feeding volumes
* Infants with cardiomyopathy
* Repeated episodes of autonomic instability (apnea/ bradycardia) not self resolving
Value of Analysing Under-utilised Leftover Tissue (VauLT)

Intratumour heterogeneity is well recognized in multiple cancer types and ultimately leads to therapeutic resistance. It also limits the ability of small samples to represent the whole tumour, having implications for diagnosis, molecular analysis and understanding of the tumour immune microenvironment. By blending- 'homogenizing'- leftover tumour tissue in excess of that required for diagnosistic purposes, one may create a more representative sample for analysis.

In order to establish the feasibility of homogenization as a potential companion diagnostic tool, our study aims to 1) evaluate how many surgical cases have left over tissue amenable to homogenization and 2) pilot homogenization across multiple tumour types. The molecular profile of the homogenate will be compared to that obtained from the diagnostic specimen using next generation sequencing techniques.

Eligibility Criteria:
Inclusion Criteria:

1. Leftover formalin-fixed tissue (ie that would be otherwise discarded by histopathology) from cancer surgery.
2. Tissues for Research consent has been provided.
3. Patient age \>18yo.
4. Minimum of 1 gram of residual tumour remaining in leftover surgical tissue
5. Minimum of 1 gram of normal tissue present.

Exclusion Criteria:

1. Advanced Practitioner in histological dissection deems tumour sample to be inadequate.
2. Leftover surgical tumour tissue greater than 20kg.
Equine-assisted Occupational Therapy for Children With Autism Spectrum Disorder

Children with Autism Spectrum Disorder have difficulty engaging in activities. This study examined the effects of equine-assisted occupational therapy for 7 children with ASD ages 4 to 8 years. A multiple baseline design was used. For each child, there were 9 to 11 baseline assessments, 9 to 12 intervention sessions, and 4 follow-up sessions.

Children with Autism Spectrum Disorder (ASD) have difficulty engaging in activities. Based on the literature, the unique features of horses may be beneficial to children with ASD. There is limited research supporting the use of horses in occupational therapy interventions. This study examined the effects of equine-assisted occupational therapy for 7 children with ASD ages 4 to 8 years. A multiple baseline design was used. For each child, there were 9 to 11 baseline assessments (gross and fine motor play activities), 9 to 12 intervention sessions, and 4 follow-up sessions (gross and fine motor play activities). Intervention sessions were 40 to 60 minutes long and consisted of time spent on the horse and in horse related activities. Children were videorecorded in all conditions. Trained coders scored randomly selected segments of the video recording. Inter-rater reliability was good.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Autism spectrum disorder by a multidisciplinary team,
* between ages 3 and 8,
* understand basic English,
* willing to ride a horse, no horse riding in the past 3 months.

Exclusion Criteria:

* severe of repeated aggressive behaviour,
* comorbidities such as deafness that would interfere with intervention.
School Reintegration After Pediatric Hematopoietic Stem Cell Transplant

This is a qualitative study that will explore the experiences of school reentry following Hematopoietic Stem Cell Transplant (HSCT) in children ages 10-16 years of age, their parents, teachers and primary PBMT(Pediatric Bone Marrow Transplant) providers. This study will involve four focus groups: children post -transplant, parents, teachers and PBMT providers in an effort to understand the successes and challenges of returning to school following HSCT.

This is a qualitative descriptive study using purposive sampling to form the four focus groups to encourage diversity in diagnosis (immunodeficiency, malignancy, bone marrow failure and inherited metabolic diseases), age and location. Each group will participate via conference call due to difference in location. There will be semi-structured questions for each group but also allow flexibility by participants themselves.

Eligibility Criteria:
Inclusion Criteria:

* Children transplanted in the PBMT program at DUMC in the past 5 years for allogeneic HSCT to include diagnoses for malignancy, immunodeficiency, bone marrow failure and inherited metabolic disease. They must have previously attended school prior to transplant

Exclusion Criteria:

* Autologous transplants
* Significant developmental delays that would impair ability to communicate
* Inability to get full team (child, parent, teacher, provider) to participate
* Non-English speaking
Pilot Study to Investigate the Creation of Physiological Rhythm by Closed Loop Stimulation in hEart Failure pAtients With chronoTropic incompEtence

The study assesses the effect of Closed Loop Stimulation (CLS) on the ventilatory efficiency slope and estimates the patient responder rate to CLS in patients with severe chronotropic incompetence treated with a cardiac resynchronization therapy (CRT) device.

In patients with pharmacological refractory heart failure (HF), systolic dysfunction, and cardiac dyssynchrony, the cardiac resynchronization therapy (CRT) reduces the risk of death, and improves symptoms and quality of life.

A considerable portion (80%) of patients with a CRT indication has a chronotropic incompetence (CI). CI usually induces a stress intolerance which negatively affects the quality of life. In addition of being a marker of diminished exercise capacity, severe CI (sCI) may be an independent predictor of mortality.

The sensor-based rate adaption provided by the implanted CRT device delivers a possible therapeutic approach for the CI.

Usually, rate adaption is achieved by an accelerometer. The previous studies in terms of effectiveness of rate adaption in CRT patients with CI showed inconsistent results.

In addition to an accelerometer to deliver the rate adaption BIOTRONIK provides closed loop stimulation (CLS) as unique feature in a CRT device. CLS determines the appropriate heart rate based on intra-cardiac impedance measurements. These measurements reflect changes of the cardiac contraction dynamics in reaction to information coming from the autonomic nervous system. CLS takes the information on the contraction dynamics and translates it into an adequate heart rate adaptation, thus delivering physiologically appropriate therapy.

Eligibility Criteria:
Inclusion Criteria:

* CRT class I indication at time of implantation, according to current guidelines
* Implantation of CRT-device including CLS \> 6 months prior to enrollment
* Stable heart failure status for at least 1 month
* Optimal cardiovascular drug treatment according to current guidelines
* NYHA class II or III
* Patient is able to comply with the protocol
* Patient provided written informed consent
* Stable location of residence

Exclusion Criteria:

* Planned cardiovascular intervention within the next 3 months
* Admission for decompensated heart failure or acute coronary syndrome in the preceding 3 months
* Ongoing symptoms of myocardial ischemia
* Known persistent, long-standing persistent or permanent atrial fibrillation
* COPD with GOLD ≥ 3
* Planned absence of residence for more than one week during study period
* Pregnant or breast-feeding women
* Participation in another interventional clinical investigation
* Age \< 18 years
* Placed in an institution due to official decree or judicial order
* Dependent from the sponsor, the clinical site or the investigators
"Score Infectivity" During Reoperation on Total Hip or Knee Prosthesis

The hip or knee is a validated treatment of end-stage osteoarthritis, and these interventions commonly make a significant improvement in the quality of life of patients. Infection can occur in 1-5% of cases. Diagnosis is often difficult, but the knowledge of infected or not infected character directly influences the surgical conduct. It is therefore recommended that the positive or negative diagnosis is made in the most reliable way possible, but no single element only allows a low diagnosis. The concomitant use of several clinical, radiological and aggregated into a composite score history could help facilitate this preoperative approach during reoperation on prosthetic joint


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* Patients operated in the service in 2014 to care for end-stage hip or knee osteoarthritis by implantation of a total hip or knee prosthesis.

Exclusion Criteria:

* Patients under 18 years