cyrilzakka/clinical-trials huggingface dataset:
68Ga-NY104 PET/CT for the Detection of Clear Cell Renal Cell Carcinoma in Presurgical Patients With Renal Masses

This is a prospective, single-center, single-arm, diagnostic phase 2 study in patients who have renal masses scheduled for surgical resection. The goal is to determine the sensitivity and specificity of 68Ga-NY104 PET/CT in the detection of clear cell renal cell carcinoma using histopathological diagnosis as ground truth, in patients with operable renal masses.

This is a prospective, single-center, single-arm, diagnostic phase 2 study in patients with renal masses scheduled for surgical resection. Each patient will receive one dose of 68Ga-NY104 by intravenous route. Dedicated whole-body PET/CT imaging will be performed. Additionally, prior to resection of the tumor, contrast-enhanced CT imaging of the abdomen, and if clinically warranted, or as part of the local standard of care, of the chest, will be performed. Both imaging modalities will be performed prior to resection of the kidney(s). PET/CT studies will be interpreted by two readers and diagnostic CT will be interpreted by one reader, all of whom will provide independent and blinded interpretations. Imaging interpretations and histopathologic evaluation data will be used to estimate the sensitivity, specificity, and predictive value (primary and secondary objectives) of each modality. The exploration into the detection of metastases by 68Ga-NY104 PET/CT in comparison to diagnostic CT will also be performed.

The pathologist will identify representative tumor tissue for the determination of histology, grading, and CAIX expression.

63 patients will be recruited in Peking Union Medical College Hospital. This study will be conducted according to local regulations and laws, the ethical principles that have their origin in the Declaration of Helsinki, and the principles of Good Clinical Practice.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 y
2. Presence of a renal mass
3. Scheduled for surgical resection of renal mass (partial or total nephrectomy, open, laparoscopic, or robot-assisted technique)
4. Expected survival of at least 3 months
5. ECOG ≤ 2
6. Written informed consent provided for participation in the trial
7. In the opinion of investigator, willing and able to comply with required study procedures.

Exclusion Criteria:

1. On VEGF TKI treatment less than 1 week before 68Ga-NY104 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC and is expected to have the same effect on 68Ga-NY104. If patients were on VEGF TKI treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NY104 PET/CT is required.
2. Intercurrent medical condition that renders the patient ineligible for surgery.
3. Pregnancy or breastfeeding.
4. Severe claustrophobia.
Raising Well at Home

The purpose of this pilot study was to test the feasibility and efficacy of a balanced lifestyle intervention for caregivers and their children with obesity, conducted in partnership with Envolve, Inc., a family of comprehensive health solutions and wholly owned subsidiary of Centene Corporation.

This pilot study employed a pretest-posttest design to assess the feasibility and efficacy of the Raising Well at Home pilot intervention delivered by peer coaches on weight (caregiver/child), behaviors (eating, walking), and the home environment. The Raising Well at Home intervention was delivered via home visits with additional support via text or phone over 6 months, beginning after completion of the baseline assessment. This study was implemented in partnership with the parent Raising Well programs located in three states: Florida, Louisiana, and Missouri. The caregiver and the child's height and weight were measured by trained staff in the home with the same scale and stadiometer at the pre- and post-intervention time points. Measures were completed on a paper survey with the same caregiver pre and post intervention delivery.

Eligibility Criteria:
Inclusion Criteria:

* Caregivers had to be at least 18 years old, live in one of the states offering the Raising Well program, and be the primary caregiver to at least one child 2-17 years old served by an Envolve Medicaid Health Plan with International Classification of Diseases, Ninth Revision (ICD-9) coding for overweight or obesity. Caregivers had to be able to give informed consent. If more than one child within a household was eligible to participate, all children were invited to participate.

Exclusion Criteria:

* Unable to speak English or Spanish
The Effect of Bath Applied in Two Different Sequences on Stress Level and Physiological Parameters in Term Babies

In this study, the bath applied to term babies in two different orders (first washing the body and lastly the head, and the classical method in which the whole body is washed starting from the head first), the babies' stress level, physiological parameters (body temperature, pulse, respiration, O2 saturation), procedure time (time of bathing). ) was planned to determine its effect on the calming time of babies.

The effects of two different bathing methods given to healthy and term babies on the babies' stress level, physiological parameters (body temperature, pulse, respiration, O2 saturation), procedure time (bathing time), and calming time of the babies will be compared.

The researcher will briefly talk about the scope and content of the research by meeting with the parents of babies who meet the selection criteria to apply the first bath of term and healthy babies before discharge, at the earliest 6 hours after birth.

Healthy, term newborns will be divided into two groups, one group will be washed from body to head, and the other group will be washed from head to body, which is the traditional method. In the study, the stress levels of babies will be obtained by observing the newborns independently by two different observer nurses before, after and after the procedure, using the "Newborn Stress Scale", at the 5th, 15th and 30th minutes. Physiological parameters of the babies will be evaluated before the procedure, during the procedure, and at the 1st, 5th and 15th minutes after the procedure. Bathing will be done by the same person (researcher) for all babies in both the experimental and control groups.

Pulse oximeter and stopwatch will be used to measure physiological parameters (heart rate, oxygen saturation, calming time).

Eligibility Criteria:
Inclusion Criteria:

* The baby's body weight is between 2.5 - 4 kg
* The baby's Apgar score is \>7
* The baby does not have any health problems
* Their parents agree to participate in the study
* Having a healthy term baby.

Exclusion Criteria:

* Meconium aspiration etc. washed immediately after birth for various reasons,
* Having various health problems,
* Their parents did not agree to participate in the study,
* Low birth weight and premature babies
A Real-Time Magnetic Device Prototype for Temporary Management of Paralytic Lagophthalmos

To develop a real-time wearable device based on the principle of magnetic force for temporary management of lagophthalmos, and evaluate its efficacy and safety, including synchronous blinks and eye closure, blurred vision, foreign body sensation over cornea or eyeball, burning or hot sensation over facial skin, and erythema or pruritus over eyelid, by performing a human trial on patients with lagophthalmos.

The wearable system includes a near-infrared (NIR) light-emitting diode (SMT910, Epitex Inc, Kyoto, Japan) and receiver (PD15-22C TR8, Everlight Electronics Corporation, New Taipei City, Taiwan), a permanent electromagnetic actuator (JNP-12/12, Joint Magnetic Technology Corporation, Shenzhen, China), an iron sheet affixed to the paralytic upper eyelid, and a bio-signal acquisition module together with a power supply unit providing a wired connection to the NIR sensor and permanent electromagnetic actuator. The palpebral gap was measured before and after the wearing of the device. The efficacy of the device prototype was assessed in terms of synchronous blinks and eye closure. Subjective sensation and complications were assessed by blurred vision, foreign body sensation over cornea or eyeball, burning or hot sensation over facial skin, and erythema or pruritus over eyelid. After the completion of the study procedure, eyelid skin condition was examined.

Eligibility Criteria:
Inclusion Criteria:

* Patient with unilateral lagophthalmos; they are capable of understanding and complying with protocol requirements
* Aged 18 years old or older

Exclusion Criteria:

* Upper eyelid scar, contracture, fibrosis, and atrophy due to previous surgical intervention(s) or traffic accident
* Patients with psychiatric (or mental) disorders; they are unable to cooperate or follow the study procedure
* Children younger than 18 years of age
Platelet-rich Plasma vs. Hyaluronic Acid for Glenohumeral Osteoarthritis

This study seeks to expand the current literature in demonstrating potentially efficacious, conservative treatments in the management of glenohumeral osteoarthritis (OA) and will compare ultrasound-guided injections of hyaluronic acid vs. platelet-rich plasma. We aim to obtain information measuring potential benefits of these interventions and to observe for any adverse events.

Glenohumeral OA accounts for approximately 2-5% of all chronic shoulder pain and may be classified into primary and secondary forms. Primary glenohumeral OA is caused by degenerative joint disease, inflammatory arthropathies, and neuropathic arthropathy secondary to syringomyelia or diabetes. Secondary glenohumeral OA is caused by trauma, postoperative changes after arthroscopy or capulorraphy, and osteonecrosis. Hyaluronic acid is found in synovial joint fluid and has viscoelastic, chondroprotective, and possibly anti-inflammatory properties. It has been shown to increase joint lubrication. Platelet-rich plasma contains growth factors that have been shown to promote tissue regeneration. The aim of this study is to determine whether injections of hyaluronic acid or platelet-rich plasma can be used reliably to decrease pain, restore function, and improve quality of life in patients suffering from glenohumeral OA. Patients will be randomized to receive either an injection of hyaluronic acid or an injection of platelet-rich plasma. Outcomes will be assessed via questionnaires for up to 52 weeks post-procedure.

Eligibility Criteria:
Inclusion Criteria:

* English speaking/literate
* Age 18-100 years
* Visual analog score pain \>= 5
* Greater than or equal to 3 months of pain after onset of symptoms that has failed conservative treatments
* Confirmation of glenohumeral OA via routine imaging (MRI and x-ray; must be recent and within the past year)
* Transient relief of symptoms after diagnostic intra-articular injection into the glenohumeral joint

Exclusion Criteria:

* Non-English speaking/illiterate
* Painful active, concurrent cervical spine conditions
* Current non-steroidal anti-inflammatory drug (NSAID) use
* History of taking coumadin or similar anticoagulant, have a known coagulopathy, bleeding dyscrasia, or platelet count \< 150,000/cubic mm
* Allergic reaction to poultry or previous viscosupplementation
* Involved in workers' compensation or active litigation involving affected shoulder
* Inability to refrain from NSAID use for 5 days prior to and 6 weeks after injection
* History of corticosteroid injection to affected shoulder within the last 3 months
* History of viscosupplementation or platelet-rich plasma to affected shoulder within the last 6 months
* Presence of acute fracture
* History of shoulder tumor
* Known uncontrolled systemic illness (uncontrolled diabetes, human immunodeficiency virus, vasculitis, autoimmune/inflammatory disease)
* Psychiatric and somatoform disorders
The Preventative and Therapeutical Effect of Ursodeoxycholic Acid(UDCA) to Short Bowel Syndrome Patients

The efficacy of UDCA in treating the parenteral nutrition-associated cholestasis(PNAC) has been identified by some studies in children without short bowel syndrome(SBS).Most of the adults who suffering PNAC have SBS. it limits the potential function of UDCA because of the lack of SBS patients and malabsorption of UDCA.Therefore, we design this clinical trial in our center of SBS to approach the preventative and therapeutical effect of UDCA to PNAC in adults with short bowel syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Patients with short bowel syndrome supported by total parenteral nutrition.
* Patients have intestine more than 50cm.
* Requirements of informed consent and assent of participant, parent or legal guardian as applicable
* Consciousness and ability to cooperate.

Exclusion Criteria:

* Patients have obstruction of biliary tract, infection, autoimmune disease, cancer
* Patients have intestine less than 50cm
* A clinically significant laboratory abnormality or a history of significant cardiac, pulmonary, hepatic, or renal disease
* Female with positive pregnancy
* Allergy to ursodeoxycholic acid
Dexmedetomidine Combined With the Closed Loop of Target Controlled Infusion of Propofol for Anesthesia With Intraoperative Wake up

The study designed to explore the efficacy and safety of the closed loop of target controlled infusion dexmedetomidine combined with propofol for anesthesia with intraoperative wake up.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Ongoing brain functional area surgery with intraoperative wake up.
* American Society of Anesthesiologists class I to II.
* Aged between 18 and 65 years old.
* Weight between plus or minus 20% of the standard weight. Male: (height cm - 80) × 70% = standard weight Female: (height cm - 70) × 60% = standard weight

Exclusion Criteria:

* History of hypertension.
* Serious heart,brain,liver,kidney, pulmonary, and endocrine disease or serious infection.
* Mental disability or mental disease.
* Use of sedative drug.
* Suspected or confirmed long term use of narcotic analgesics.
* Inability to exchange.
* Suspected or confirmed difficult airway.
* Suspected of malignant hyperthermia.
* Neuromuscular disease.
* Allergic to investigational products or with other contraindication.
* Subjects who are breastfeeding or pregnant.
* Participated in other study within 30 days .
Monitoring Functional Variation in the Breast During Menstrual Cycle by Using Diffuse Optical Spectroscopy

The purpose of this study is to do determine the changes in physiological and optical properties in healthy pre-menopausal breast tissue during the menstrual cycle using Diffuse Optical Spectroscopy. The Researcher can determine 1) how large variations in breast tissue components are 2) how predictable and repeatable these variations are 3) the effects of endogenous hormones on breast tissue physiology.

Variations in breast physiology due to hormonal fluctuations during the menstrual cycle can correlate to quantitative changes in Diffuse Optical Spectroscopy functional parameters such as hemoglobin, lipid and water concentration and tissue scattering. Diffuse Optical Spectroscopy imaging can show increase blood flow in breast tissue after ovulation with a concomitant increase in mitotic activity, changes in hemoglobin concentration and in tissue scattering. Increases in fibroglandular breast tissue after ovulation have also been observed. Diffuse Optical Spectroscopy imaging can determine after time of ovulation has been detected during the two months of self-monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Pre-Menopausal female 18 years of age or older with normal breast tissue
* Undergoes regular menstrual cycle cycles that do not vary by more than 5 days

Exclusion Criteria:

* Peri-Menopausal and Post-Menopausal
* Subjects taking oral contraceptives or any birth control medications in the past six months
* Diagnosed with breast cancer or cancer survivor,a history of breast surgery
* Subjects taking light sensitive drugs for photodynamic therapy
Thyroid Disease Serum Repository

Thyroid disease is more common among females and is increasing in incidence.

Otolaryngology faculty members and residents will perform head and neck examinations as part of the subject's routine care. If the participant is noted to have thyroid disease, they will be asked if they would like to participate in the research portion by having approximately 10cc's of blood drawn. Faculty and staff will complete a data collection sheet that will contain demographic and clinical data.


Eligibility Criteria:
Inclusion Criteria:

* Participants with benign or malignant thyroid disease.
Survey of Regional Anesthesia Practice in Poland

The study is being conducted to gain insight into regional anesthesia practice in polish hospitals specifically asking for methods used, accessibility to equipment and preference for regional blockade and perioperative analgesia.

In recent years, regional anesthesia has become one of the most dynamic parts of anesthesiology. This is in part due to less invasive surgical procedures, surgical enhanced recovery protocols as well as the incorporation of ultrasonography into the daily practice of regional anesthesia.

The aim of this retrospective survey is to track and analyse the changes in everyday practice of regional anesthesia in Poland that have occurred in the year 2018.

An invitation to the survey will be sent to all heads of anesthesiology departments in Poland. The answers to the survey will be collected using an internet based website created by the authors of the study.

Eligibility Criteria:
Inclusion Criteria:

* All Polish hospitals practising anesthesiology and intensive care in the national register of medical practices (www.rpwdl.csioz.gov.pl)

Exclusion Criteria:

* Hospitals and medical practices not practising anesthesiology or intensive care
Chemotherapy Alone Versus Chemotherapy Plus Targeted Therapy as Adjuvant Therapy for Initially Unresectable Colorectal Cancer Liver Metastases

Chemotharapy plus targeted therapy regimen, as an adjuvant therapy, can effectively reduce the rate of both intrahepatic and extrahepatic recurrence in initially unresectable CRLM patients. Those with KRAS/NRAS/BRAF mutated tumors or cycle of conversion therapy ≤ 4 can benefit more from chemotharapy plus targeted therapyrather than from chemotharapy alone, with a tolerable toxicity profile.

This multi-center study enrolled consecutive patients with initially unresectable CRLM who underwent conversion therapy or radiofrequency ablation (RFA) and achieved no NED status between June 1, 2013, and June 30, 2020, from Zhongshan Hospital of Shanghai, Zhongshan Hospital of Xiamen, Cancer Hospital of Beijing. The inclusion criteria were as follows: (1) with histologically confirmed CRC; (2) with initially unresectable synchronous liver metastases (LMs); (3) accepted conversion therapy and successfully converted into resectable status; (4) underwent R0 intestinal and hepatic resection; (5) accepted adjuvant therapy. The exclusion criteria were as follows: (1) R1/R2 resection; (2) extrahepatic metastases; (3) accepted postoperative monotherapy; (4) lack of follow-up data. According to the adjuvant therapy regimen (with or without targeted therapy), the cohorts were divided into CA cohort and CT cohort. The study was approved by the ethics committee of three medical centers and was adhered to Good Clinical Practice guidelines and the Declaration of Helsinki. Written informed consent was obtained from all participants.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤ 75 years;
2. Histologically confirmed CRC;
3. Initially unresectable synchronous liver metastases (LMs);
4. Accepted conversion therapy and successfully converted into resectable status;
5. Underwent R0 intestinal and hepatic resection;
6. Accepted adjuvant therapy.

Exclusion Criteria:

1. R1/R2 resection;
2. Extrahepatic metastases;
3. Accepted postoperative monotherapy;
4. Lack of follow-up data.
Suture Fixation System Versus Tendonous Reconstruction in Carpometacarpal (CMC) Arthroplasty

Thumb carpometacarpal (CMC) arthritis affect 1 in 4 females and 1 in 12 males. Patients who fail to respond to conservative treatment may benefit from surgery; however, controversy exists over the most effective surgical technique. A popular technique, ligament reconstruction with tendon interposition (LRTI) involves a trapeziectomy, followed by reconstruction of the palmar oblique ligament using a harvested flexor tendon from the wrist.

We believe that use of a suture fixation system to reconstruct the palmar oblique ligament, instead of harvesting a wrist tendon, may provide a superior repair. The objective of this study is to compare functional outcome measurements among patients who receive CMC arthroplasty using a suture fixation system (investigational group) to those who receive LRTI surgery (control group). We hypothesize that patients in the investigational group will demonstrate superior functionality, compared to patients in the control group.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged \>18.
* Eaton Stage III or IV CMC arthritis
* Failure to respond to conservative treatment

Exclusion Criteria:

* Previous surgical interventions on that thumb
* Upper extremity neurological dysfunction
* Inability to effectively communicate with the research staff, due to hearing impairment, cognitive impairment, or a language barrier
* Unwilling or unable to provide written informed consent
Extracorporeal Membrane Oxygenation Effect in Prolonged Cardiopulmonary Resuscitation

Analysis of the patients' data who were rescued with extracorporeal membrane oxygenation and without ECMO. The survival rate and the weaning rate were analyzed to see the effect of ECMO on the prolonged CPR.


Eligibility Criteria:
Inclusion Criteria:

* CPR \> 10 min without return of spontaneous circulation

Exclusion Criteria:

* CPR with traumatic origin unless bleeding was under control, previous irreversible brain damage, terminal status of malignancy, and the age over 75 years. For the patients with post-cardiotomy shock requiring ECLS in the operating theater because of an inability of weaning from cardiopulmonary bypass, they were excluded as well from this ECPR cohort since they did not receive cardiac massage. The patients that had signed "Do-Not-Resuscitate" (DNR) consent were also excluded from ECLS deployment.
AdaptiveStim Objectifying Subjective Pain Questionnaires

This is a prospective, multi-center, correlation study in which the investigators aim to explore the relationship between subjective pain questionnaires and the AdaptiveStim accelerometer output.

The aim of this research is to gather the necessary information relating to the patient his subjective self-report and the more objective information from the implanted IPG (RestoreSensor). Such subjective information can be gathered from the AdaptivStim output.

The main focus of this study is to explore the relationship between the subjective reporting of functional disability with the ODI, sleep quality with the Actiwatch and PSQI, pain intensity with the NRS-diary and the objective measurement of functional positions with the AdaptiveStim in patients receiving high density spinal cord stimulation.

Eligibility Criteria:
Inclusion Criteria:

* FBSS patients treated with SCS (IPG = RestoreSensor) who achieved a steady state (steady state is considered when the parameters didn't changed for at least one month)
* Age \> 18 years

Exclusion Criteria:

* Patients with Parkinson's disease
* Patients immobilised due to limb/pelvis/costal fractures
* Stroke patients with MRS\>3