cyrilzakka/clinical-trials huggingface dataset:
Study of PET Imaging With 18F-TFB in Patients With Thyroid Cancer

The goal of the study is to evaluate a new imaging test that may allows the investigators to predict the uptake of radioactive iodine by thyroid cancer faster than the current standard and that does not interfere with the uptake of radioactive iodine used for therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically or cytologically confirmed thyroid carcinoma of follicular origin (including papillary and its respective variants).
* Patients should have tumors that are radiographically evident on PET, ultrasound, CT or MRI
* Age ≥ 18 years.
* ECOG performance status ≤ 2 (or Karnofsky ≥60%).
* Patients must have normal organ and bone marrow function as defined below:

  * Absolute neutrophil count (ANC) \> 1.5x10\^9/L
  * Hemoglobin ≥ 9 g/dL
  * Platelets ≥ 100 x 10\^9/L
  * Albumin ≥ 2.5 g/dL
  * Total bilirubin ≤ 1.5x institutional ULN
  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2x institutional ULN unless it is related to the primary disease
  * Creatinine ≤ 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) ≥ 50 mL/min OR 24-hour urine creatinine clearance ≥ 50 mL/min
* Negative pregnancy test within 7 days prior to starting the study in premenopausal women. Women of non-childbearing potential may be included without pregnancy test if they are either surgically sterile or have been postmenopausal for ≥ 1 year.
* Fertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician. Effective methods of contraception are defined as those, which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (for example implants, injectables, combined oral contraception or intra-uterine devices). At the discretion of the Investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, postovulation methods\] and withdrawal are not acceptable methods of contraception.)
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant, lactating, or breast feeding women.
* Patients unable to follow a low iodine diet or requiring medication with high content in iodide (amiodarone).
* Patients who received iodinated intravenous contrast as part of a radiographic procedure within 3 months of study registration. Those that have had iodinated intravenous contrast for CT imaging within this time frame may still be eligible if a urinary iodine analysis reveals that the excess iodine has been adequately cleared after the last intravenous contrast administration.
* Unwillingness or inability to comply with study procedures.
Comparison of Efficacy of LGIT and MAD Among Children With Drug Resistant Epilepsy

To compare the efficacy of two less restrictive dietary therapies - LGIT and MAD, used for treatment of drug resistant epilepsy in children

Up to one third of patients with epilepsy progress to drug resistant epilepsy (DRE). Current treatment options for DRE include epileptic surgery and dietary therapy. Classic KD (Ketogenic diet) is the most studied dietary therapy but the stringent restrictions and practical difficulty makes it difficult to follow. So less restrictive diets like MAD and LGIT were introduced. These are reported to have less adverse effects also. But no published study has ever been conducted comparing these two diets head to head.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 1-15 years with drug resistant epilepsy
* Willing to come for regular follow-up according to study protocol Drug resistant epilepsy defined as
* Seizure frequency \>4 seizures per month, while on optimal doses of at least 2 prescribed antiepileptic drugs
* For West syndrome, drug resistant epilepsy will be defined as more than 4 clusters of spasms per month despite treatment with antiepileptic drugs and either ACTH(Adrenocorticotrophic hormone) or Vigabatrin

Exclusion Criteria:

* Surgically remediable causes for DRE
* Inborn errors of metabolism
* Previously received KD, MAD or LGIT
* Known case of

  1. Chronic kidney disease
  2. Chronic liver disease/GI illness
  3. Congenital/acquired heart disease
  4. Chronic respiratory illness
Crochet Octopus in The Process of Heel Lance in Neonates

The main objective of the study was to determine the effect of using crochet octopus in order to reduce the acute pain developed during the process of heel lance in neonates.

The hypothesis of the study was "Crochet octopus is rather effective in reducing the acute pain in heel lance process for neonates".

The study was conducted as randomized controlled. It included term neonates born between May 2020 and August 2020 at a training and research hospital. The study was completed with 100 neonates in total as 50 for experiment and 50 for control groups. During the process of heel lance, experiment group neonates were delivered crochet octopus 10 minutes before the process and let them touch the octopus 10 minutes more after the process. Control group neonates experienced the process without any intervention. As for the data collection, "Newborn Identification Form", "Neonatal-Infant Pain Scale (NIPS)" and "Observation Form" were utilized. The whole process was video-recorded.

Eligibility Criteria:
Inclusion Criteria:

* being a healthy term neonates,
* being 5-15 days,
* taking of blood sample for Guthrie test routinely.

Exclusion Criteria:

* admitted to the neonatal intensive care units
* his/her being taken any analgesics prior to the intervention,
* having any congenital anomalies
Mobile Devices to Detect Early Pneumonitis in Stage III NSCLC Patients on Durvalumab.

A study of whether mobile devices can improve the detection of pulmonary AEs (including pneumonitis) in stage III NSCLC patients post-CRT, while on durvalumab.

Patients undergoing post-CRT treatment for lung cancer with consolidation durvalumab can experience pulmonary AEs that could become severe if not recognized and treated in time.

Data collected will be used to evaluate the likelihood of early detection of pulmonary AEs in unresectable Stage III NSCLC patients on durvalumab. This project seeks to understand if multiparametric mobile technology collecting patient reported outcomes, vital signs, and respiratory function, integrate well into a patients daily life and aid physicians in early detection of pulmonary AEs.

Eligibility Criteria:
Select Inclusion Criteria:

* Patient has unresectable Stage III NSCLC that has not progressed following concurrent platinum-based chemotherapy and radiation therapy and is eligible to receive durvalumab according to the US FDA approved package insert.
* Patient is able and willing to use the mobile application and connected devices.
* Patient is able to complete QoL assessments.

Select Exclusion Criteria:

* Patient is currently oxygen dependent.
* Patient has comorbidities that will prevent consistent and reliable measurement assessments with multiparametric mobile technology including severe chronic obstructive pulmonary disorder (COPD), severe asthma, congestive heart failure \[CHF\], interstitial lung disease \[ILD\], and others.
* Patients on other immunotherapy or systemic immunosuppressants.
* Patients with active or prior autoimmune disease or history of immunodeficiency.
* Currently pregnant women.
A Phase 2a Study of the Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to evaluate the clinical efficacy and safety of OD-07656 in participants with moderately to severely active ulcerative colitis (UC). In addition, the study will evaluate the potential of OD-07656 to enhance the therapeutic benefit of vedolizumab when given after OD-07656.


Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has a confirmed diagnosis of ulcerative colitis (UC)
* Has moderate to severely active UC as defined by the 3-component Modified Mayo clinic score
* Has an inadequate response, loss of response, or intolerance/medical contraindication to at least one of the following therapies: oral aminosalicylates, corticosteroids, immunosuppressants, anti-tumor necrosis factor biologic, anti-interleukin 12/23 biologic, Janus kinase inhibitors, or sphingosine-1-phosphate (S1P) modulators

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has diagnosis of Crohn's disease or indeterminate colitis
* Has had extensive colonic resection
* Has colostomy or ileostomy
* Has uncontrolled primary sclerosing cholangitis
Prevalence of Cholelithiasis with Umbilical Hernia

Researchers aim to determine the exact prevalence and risk factors for the association of gallstones and umbilical hernia. Umbilical hernia is defined according to the European Hernia Society Classification for primary and incisional abdominal wall hernias as hernias occurring from 3 cm above to 3 cm below the umbilicus. The main outcome measures are the presence of gallstones in patients presenting with umbilical hernia and the presence of umbilical hernia in patients diagnosed with gallstones. Patients with umbilical hernia are examined with biliary ultrasound, while patients with cholelithiasis are evaluated for umbilical hernia by physical examination and ultrasound. Factors such as age, gender, body mass index (BMI), family history, comorbidities, tobacco use, parity, and history of multiple pregnancy are analyzed as potential risk factors.

Umbilical hernia and cholelithiasis are quite common in general surgical practice. The coexistence of cholelithiasis and umbilical hernia has been previously reported in the literature. However, most of the publications on this subject are retrospective series, and the prevalence of cholelithiasis in patients with umbilical hernia and the risk factors of umbilical hernia in patients with cholelithiasis have not been investigated prospectively to date. This study aims to fill this gap by providing prospective data on the prevalence and risk factors associated with the coexistence of these conditions.

Researchers aim to determine the exact prevalence and risk factors for the association of gallstones and umbilical hernia. Umbilical hernia is defined according to the European Hernia Society Classification for primary and incisional abdominal wall hernias as hernias occurring from 3 cm above to 3 cm below the umbilicus. The main outcome measures are the presence of gallstones in patients presenting with umbilical hernia and the presence of umbilical hernia in patients diagnosed with gallstones. Patients with umbilical hernia are examined with biliary ultrasound, while patients with cholelithiasis are evaluated for umbilical hernia by physical examination and ultrasound. Factors such as age, gender, body mass index (BMI), family history, comorbidities, tobacco use, parity, and history of multiple pregnancy are analyzed as potential risk factors.

Eligibility Criteria:
Inclusion Criteria:

* Patients with umbilical hernia
* Patients with cholelithiasis

Exclusion Criteria:

* Having previously had surgery for an umbilical hernia
* Having undergone abdominal surgery with a median line incision
* having collagen tissue disease
NIRF Trial: Near-Infrared Spectroscopy for Intraoperative Restriction of Fluids Trial

The purpose of this study is to evaluate if the InSpectra StO2 Monitor can safely guide the amount of fluid needed during colorectal surgery.

The study hypothesis is that intraoperative fluid limitation can be safely accomplished when guided by StO2 monitoring, and that this fluid restriction regimen will result in a reduction in postoperative morbidity when compared to standard monitoring and fluid therapy.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective open colorectal surgery
* Age greater than or equal to 18 years
* Low to moderate risk colorectal surgery patients

Exclusion Criteria:

* Unacceptable Baseline vital sign measurements
* High risk colorectal surgery patients
* Jehovah's Witness
Investigational Scan (68Ga-FAPI-46 PET/CT) for Imaging of Cancer-Associated Fibroblasts for Localized Pancreatic Ductal Adenocarcinoma

This phase II trial tests whether 68Ga-FAPI-46 positron emission tomography (PET)/computed tomography (CT) scan works to image cancer-associated fibroblasts (CAFs) in patients with pancreatic ductal adenocarcinoma (PDA) that has not spread to other parts of the body (localized). CAFs are a type of connective tissue cell that are found within or near cancerous tissue. Many CAFs express a protein called fibroblast activation protein (FAP) that are not found on healthy cells in large amounts. 68Ga-FAPI-46 is a radioactive chemical compound designed to circulate through the body and attach itself to FAP on PDA cells. A PET/CT scan is then used to detect the location of FAP lesions. PET scan is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Because cancer cells often take up more glucose than normal cells, the pictures can be used to find cancer cells in the body. CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional (3-D) views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination. Giving 68Ga-FAPI-46 PET/CT may help doctors improve upon the diagnosis and management of PDA.

PRIMARY OBJECTIVES:

I. To determine the sensitivity and specificity of gallium Ga 68 FAPi-46 (68Ga-FAPI-46) PET for detection and quantification of cancer-associated fibroblasts (CAFs) in pancreatic ductal adenocarcinoma (PDA).

II. Construct, test and validate a model of surgical benefit or futility in potentially resectable PDA using 68Ga-FAPI-46 PET biomarkers in combination with other biomarkers of disease.

OUTLINE:

Patients receive 68Ga-FAP-46 intravenously (IV), then allow 60 minutes for 68Ga-FAPI-46 uptake. Patients then undergo PET/CT scans over 30 minutes at baseline (before standard of care \[SOC\] therapy), up to 2 scans approximately 8 weeks apart (at SOC re-staging visits), and a then a scan within 4 weeks of SOC surgical resection, if applicable.

After completion of study treatment, patients are followed up for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years (yrs.) with treatment-naive biopsy-proven PDA or with findings diagnostic for PDA on baseline imaging (CT, MRI, or PET)
* Localized disease expected to undergo surgical resection following neoadjuvant therapy (NAT)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Ability to provide informed consent

Exclusion Criteria:

* Hypersensitivity to any excipients in 68Ga-FAPI-46
* Require emergency surgery
* Non-PDA histology on biopsy
* Histopathologically proven metastatic PDA
* Pregnant or lactating women
Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy

The primary purpose of this study is:

1. To compare dexmedetomidine with fentanyl in terms of intra-operative hemodynamics and post-operative analgesia.
2. To determine an analgesic dose response relationship for dexmedetomidine.
3. Compare recovery characteristics of dexmedetomidine to fentanyl.


Eligibility Criteria:
Inclusion Criteria:

* All of the following criteria must be met for the potential subject to be eligible for participation:

  1. The subject is 2 to 12 years of age
  2. The subject's American Society of Anesthesiologists physical status is ASA I or II (see appendix 1).
  3. The subject is scheduled for elective tonsillectomy with or without adenoidectomy surgery (procedures with myringotomy tube placement are allowed).
  4. The subject will be hospitalized overnight after surgery
  5. The subject's parent/legally authorized guardian has given written informed consent to participate; and where applicable, the subject has given appropriate assent to participate.

     Exclusion Criteria:
* The potential subject is NOT eligible for participation if any of the following exclusion criteria apply:

  1. The subject has a history or a family (parent or sibling) history of malignant hyperthermia
  2. The subject has known significant renal or hepatic disorders determined by medical history, physical examination or laboratory tests.
  3. The subject has a known or suspected allergy to opioid analgesics
  4. The subject is a pregnant or lactating female (if post-menarcheal, a negative pregnancy test must be confirmed prior to the planned surgery time (in AMSAC) consistent with current standard of care.
  5. The subject has history of. cardiovascular issues which would preclude the use of dexmedetomidine, (e.g. Down's Syndrome, dysrhthymias, conditions where hypotension is to be avoided).
The Effect of High-Intensity Focused Electromagnetic on Urinary Incontinence Symptoms

This study is aimed at women's pelvic floor muscles, especially urinary incontinence caused by pelvic floor muscle relaxation or pelvic prolapse, to observe whether the use of (HIFEM) high-intensity focused magnetic energy chairs can help the pelvic floor muscles after this treatment Strengthening to improve the symptoms of urinary incontinence caused by the compression of the sacral nerve plexus caused by the downward movement of the uterus, thereby improving the social life and quality of life of the patient.


Eligibility Criteria:
Inclusion Criteria:

1. Women over 20 years old.
2. Symptoms of urinary incontinence (including: stress incontinence, urge incontinence).
3. Blood tests confirmed that the number of platelets was 150,000-450,000/UL, and the coagulation function (PT) index was normal.

Exclusion Criteria:

1. Pregnant and lactating women.
2. Patients with acute or chronic cardiovascular disease.
3. Patients with acute or chronic infectious diseases.
4. Patients with malignant tumors, uterine fibroids, and gynecological cysts, who have been evaluated by doctors as unsuitable.
5. Those who have undergone lower abdominal or genital-related surgery and have been evaluated by doctors as unsuitable.
6. Patients with pulmonary insufficiency.
7. People with metal and electronic implants (such as: pacemaker, defibrillator, neurostimulator).
8. Those with bleeding disorders or receiving anticoagulant therapy.
9. Use drug pumps.
10. People with skin allergies or skin diseases.
11. Those unable to sign the subject's consent form.
Yoga for Solid Tumor

The purpose of this study is to ascertain the effect of yoga interventions on radiation-related fatigue, and stress in cancer patients with stage I and II solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Stage I and II Cancer patients with solid tumors undergoing RT for 4-8 weeks (external beam radiation).
2. Patients of age \>18, and all races will be included in the study.
3. All patients must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Pennsylvania.
4. Patients must be English speaking.
5. Patients must be able to attend the schedule classes.

   Exclusion Criteria:
6. Patients with medical restrictions that may interfere with or prevent them from taking part in the yoga interventions per their physician orders.
7. Patients with metastatic disease.
8. Active smokers. Smoking may interfere with relaxation and breathing modalities of the yoga interventions. (Self-reporting smokers that have been smoke free for 6 months may be included)
9. Patients who currently practice or have recently practiced yoga (had not taken a yoga class on a regular bases in the last 6 months).
Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer

The purpose of this study is to determine whether S-1 and oxaliplatin as neoadjuvant chemotherapy may improve survival benefit compared with control.


Eligibility Criteria:
Inclusion Criteria:

1. DISEASE CHARACTERISTICS:

   Histologically confirmed gastric adenocarcinoma Locally advanced disease:Clinical stage T3-4, N0-3, M0 (according to the Japanese gastric cancer classification)
2. Planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy
3. Age:20 to 75
4. Performance status:ECOG 0-2
5. Life expectancy:Not specified
6. Hematopoietic:WBC 4,000-12,000/mm\^3；Granulocyte count ≥ 2,000/mm\^3；Platelet count ≥ 100,000/mm\^3；Hemoglobin ≥ 9.0 g/dL;Hepatic:AST and ALT ≤ 100 U/L；Bilirubin ≤ 1.5 mg/dL
7. Adequate organ function
8. Able to swallow oral medication
9. Written informed consent

Exclusion Criteria:

1. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
2. Pregnant or breast-feeding women
3. Severe mental disease
4. Systemic administration of corticosteroids, flucytosine, phenytoin or warfarin
5. Other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease
6. Myocardial infarction within six disease-free months
PET Imaging Study of Recovered Anorexics

Several studies in the past suggest that individuals who have or had anorexia nervosa may have alterations in brain serotonin. Serotonin seems to play an important role in regulating anxiety, mood, and other symptoms found in anorexia nervosa. We will be using a technology called Positron Emission Tomography (PET), which is a method used to take pictures of the body, in this case, the brain. Study participants will undergo two baseline PET scans on the first day of the study. The women who have recovered from anorexia will then be given a medication called fluoxetine (also know as Prozac) to take for 8 weeks. At the end of the 8th week, they will return for a third PET scan. By comparing the brain scans, before and after fluoxetine treatment, we can understand more about how treatment with fluoxetine affects the serotonin receptors in the brain. We will be comparing brain serotonin system in women who have recovered from anorexia before and after medication in order to gain a better understanding of changes in the serotonin system associated with eating disorders. This study may help shed light on how to make fluoxetine a more effective treatment for anorexia nervosa.


Eligibility Criteria:
Inclusion Criteria:

* Recovered from Anorexia Nervosa
* Not taking medication for emotional problems
* Regular menstrual cycle

Exclusion Criteria:

* Women who are pregnant or nursing
* Psychoactive medications in the past 30 days
* Neurological disorders.