cyrilzakka/clinical-trials huggingface dataset:
68Ga-NOTA-RM26 PET/CT for the Detection of Gastrointestinal Stromal Tumor

This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-RM26 in Gastrointestinal stromal tumor（GIST）patients. A single dose of 55.5 to 148 MBq(1.5-4 mCi) of 68Ga-NOTA-RM26 will be injected intravenously. Patients underwent whole-body PET/CT scans at 30-90 minutes after intravenous injection.

Rm26 is a bioactive polypeptide containing 9 amino acid residues, which can specifically bind to gastrin releasing peptide receptor (GRPR, BB2 receptor). Previous studies have confirmed that there are a large number of GRPR receptors in human common types of tumors, such as lung cancer, breast cancer, prostate cancer, head and neck squamous cell carcinoma, glioma and gastrointestinal tumors. Therefore, the use of various radionuclide labeled gastrin releasing peptide receptor analogues RM26 for tumor targeted imaging and treatment greatly improves the early detection rate of tumor, and has important clinical significance and value in tumor staging, prognosis evaluation and curative effect evaluation.This prospective pilot study investigated the use of 68Ga-NOTA-RM26, an antagonist targeting gastrin-releasing peptide receptor (GRPR), for evaluating breast cancer using positron-emission tomography/computed tomography (PET/CT).

Eligibility Criteria:
Inclusion Criteria:

* Patients in suspicion of gastrointestinal stromal tumors by CT or ultrasonography,and being able to provide basic information and sign the written informed consent form.

Exclusion Criteria:

* The exclusion criteria included claustrophobia, pregnancy, breastfeeding, kidney or liver failure, inability to fulfill the study, and undergoing any preceding local or systemic therapies that might interfere with GRPR binding.
Prevention of Preterm Birth With a Pessary in Singleton Gestations

Preterm birth (PTB) is associated with over one million infant deaths annually worldwide. The incidence of PTB in the United States is 11.5% with more than 500,000 deliveries occurring at less than 37 weeks gestation annually. The rate of PTB in the United States increased to 12.8% in 2006, and remains high compared to almost all other developed countries, despite the introduction of many public health and medical interventions designed to delay PTB. Weekly treatment with 17-alpha hydroxyprogesterone caproate beginning at 16-20 weeks gestation has been shown to significantly reduce the risk of PTB and is currently recommended for women who experienced spontaneous PTB in a prior pregnancy. However, a strategy for the prevention of spontaneous PTBs in which therapeutic intervention is restricted to women with a previous PTB is likely to have a small effect on the overall rate of prematurity since only about 10% of spontaneous PTBs arise in women with such a history. A major reduction in rates of mortality and morbidity in premature babies will only be achieved with increased precision in the identification of women at risk of spontaneous PTB and through the development of an effective prevention for this complication. Transvaginal ultrasound measurement of cervical length is a reliable screening test for prediction of PTB. Although treatment with vaginal progesterone is effective in decreasing PTB in women with a short cervix, over 30% of women still experience premature delivery and many women find daily administration of progesterone to be challenging. Preliminary studies have suggested that use of an intravaginal pessary may be effective in preventing PTB. If effective this approach would be particularly appealing because of the wide availability of pessaries, ease of use, and low cost. Unfortunately, existing studies are inadequate to confirm effectiveness; a well designed, properly powered, prospective randomized trial is warranted prior to widespread implementation in clinical practice. We propose such a trial to study the effectiveness of the pessary in decreasing the incidence of PTB in an inner city Philadelphia population.


Eligibility Criteria:
Inclusion Criteria:

* 18-50 years of age
* Singleton pregnancy (limits the participants to female gender)
* Short cervical length (less than or equal to 25 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation

Exclusion Criteria:

* Multiple gestation
* Prior spontaneous preterm birth 16-36 6/7 weeks
* Ruptured membranes
* Lethal fetal structural anomaly
* Fetal chromosomal abnormality
* Cerclage in place (or planned placement)
* Vaginal bleeding
* Suspicion of chorioamnionitis
* Ballooning of membranes outside the cervix into the vagina or CL = 0 mm on transvaginal ultrasound
* Painful regular uterine contractions
* Placenta previa
A Study to Assess the Effectiveness of PROCRIT (Epoetin Alfa) Dosing Every 2 Weeks Versus Once a Week in Anemic HIV-infected Patients

The purpose of this study is to determine if PROCRITÂ® (a glycoprotein that stimulates red blood cell production) initiated at once every 2 weeks dosing is as effective as PROCRITÂ® initiated at once a week dosing, in increasing hemoglobin levels in anemic HIV-infected subjects.

In the Highly Active Antiretroviral Treatment (HAART) era, anemia is one of the most common abnormalities in HIV-infected subjects. Epoetin alfa is proven to increase hemoglobin levels and improve quality of life in HIV-infected subjects. Although there are data to show that epoetin alfa dosed weekly significantly increases hemoglobin to a target level of 13 g/dL and every other week dosing can maintain target hemoglobin, there is no data to show that initiation of epoetin alfa every 2 weeks will increase hemoglobin levels significantly.

This randomized, two-arm, open-label study will evaluate if initiating PROCRIT® every other week dosing is as effective as initiating PROCRIT® weekly dosing, in increasing hemoglobin in anemic HIV-infected subjects. The Screening phase will start 2 weeks prior to the first dose of PROCRIT®. HIV-infected subjects who have a hemoglobin level of \<12.0 g/dL and are on a stable antiretroviral regimen will be screened for study eligibility. In the treatment phase, subjects will be randomized in a 1:1 ratio to receive 40,000 IU PROCRIT® subcutaneous injections either weekly (QW) or every other week (Q2W). The primary endpoint is the change in hemoglobin from baseline to the end of study at Week 12. The safety and tolerability of PROCRIT® in this subject population will be assessed by evaluating adverse events, laboratory results and vital signs. The total duration of this study is 14 weeks, including a 2-week screening phase and a 12-week treatment phase. The primary hypothesis is that the mean increase in hemoglobin for subjects receiving PROCRIT® every 2 weeks is not lower than those receiving weekly PROCRIT® dosing by more than 1 g/dL. Subjects will initially receive 40,000 IU PROCRIT® subcutaneous injections either weekly (QW) or every other week (Q2W), with subsequent dose adjustments, if appropriate. The maximum length of PROCRIT® treatment for this study is 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be documented HIV positive and on a stable antiretroviral regimen for at least four weeks prior to enrollment
* have a hemoglobin level \<12.0 g/dL
* have not undergone cancer therapy (chemotherapy and/or radiation therapy) within 12 months prior to enrollment

Exclusion Criteria:

* History of acute, symptomatic opportunistic infection or other acute AIDS defining illness within six months of enrollment
* History of any primary hematologic disease
* Have anemia attributable to factors other than HIV infection (i.e. iron, or vitamin B12 deficiency, hemolysis, or gastrointestinal bleeding)
* Have Hepatitis C virus (HCV) co-infection
* Have uncontrolled or severe cardiovascular disease including recent myocardial infarction, hypertension, or congestive heart failure
Analgesic Efficacy of Oral Glucose in Preterm Neonates During Suctioning

Nasopharyngeal suctioning is a painful procedure that often becomes necessary in the care of preterm infants under CPAP therapy several times a day. Since the use of analgetic and sedative drugs is accompanied with multiple side effects these are usually being avoided. Glucose 20% has been shown to have an analgesic effect when administered to preterm infants previous to some painful procedures (i.e blood sampling).

In this clinical trial the efficacy of orally administered Glucose 20% for relieving the procedural pain of nasopharyngeal suctioning is tested. The investigators' study has a cross-over design and is to include 40 patients.


Eligibility Criteria:
Inclusion Criteria:

* Preterm newborns (\>1500g birth weight) up to a gestational age of 36+6 weeks
* CPAP respiratory therapy
* Parents' given written consent

Exclusion Criteria:

* Diseases complicating neuromuscular evaluation.
* Drug abuse by the mother
* Administration of other analgetic or sedative drugs within the previous 48h.
* Participation in another interventional clinical trial within 4 weeks before the beginning of this trial.
The Effect of Monitoring PVP on Clinical Outcomes in Patients With PH

The complications associated with portal hypertension in cirrhosis are the main cause of death in patients with cirrhosis. The level of portal venous pressure is closely related to the prognosis of patients. HVPG (hepatic venous pressure gradient) is the "gold standard" for predicting portal venous pressure and an important indicator for evaluating the efficacy of NSBBS. However, monitoring HVPG has many limitations，and the clinical application is also limited to a certain extent. Therefore, this study intends to clarify the guiding value of monitoring portal venous pressure in the clinical diagnosis and treatment of portal hypertension patients through a single-center, prospective and observational study. Therefore, this study intends to clarify the guiding value of monitoring portal venous pressure in the clinical diagnosis and treatment of portal hypertension patients through a single-center, prospective and observational study. At the same time, to explore the correlation between HVPG and PPG in cirrhosis patients at different stages and different etiologies, and to evaluate the role of spleen stiffness in predicting the severity of esophageal and gastric varices in patients with portal hypertension, and to find biomarkers to predict the risk of complications related to portal hypertension.


Eligibility Criteria:
Inclusion Criteria:

* With chronic liver disease
* Age 18-80 years
* Patients who require a portal pressure measurement at the discretion of the treating physician
* Voluntarily signed informed consent

Exclusion Criteria:

* With serious cardiopulmonary disease or other diseases affect survival
* With severe renal dysfunction
* Concomitant portal vein cavernous degeneration or extensive portal vein thrombosis
* Women who are planning to become pregnant or who are pregnant or breastfeeding
* The researcher judged that it was not suitable to participate in this study
Surgery for Esotropia Under Topical Anesthesia

Adult patients requiring surgery for esotropia will be randomized to surgery under topical anesthesia or sub-Tenon's anesthesia. Amount of surgery required with the two anesthetic procedures will be compared. Motor and sensory outcome of the two treatment groups will also be compared.


Eligibility Criteria:
Inclusion Criteria:

* Esotropia deviation angle equal to or lower than 45 prism dioptres (requiring one or two-muscle surgery)
* Visual acuity at least 20/40 in each eye
* Cooperation for topical anesthesia

Exclusion Criteria:

* Paretic or restrictive strabismus
* Previous eye muscle surgery
* Significant eye disease other than strabismus
Determine Safety and Effectiveness of Tadalafil in Asian Men When Taken as Needed for Getting and Keeping an Erection

Study to determine if tadalafil works better than placebo for Asian men having trouble getting or keeping an erection.


Eligibility Criteria:
Inclusion Criteria:

* History of erection problems
* Anticipate a monogamous female sexual relationship
* Abstain from other erection treatments at least 4 weeks before first dose and throughout the study
* Must be able to make required sexual intercourse attempts

Exclusion Criteria:

* Other primary sexual disorders
* History of radical prostatectomy or other pelvic surgery that affected being able to have an erection
* History of penile implant or clinically significant penile deformity
* Nitrate use
* Certain heart problems
A High-Resolution Magnetic Resonance Imaging Study to Evaluate the Effect of Rosuvastatin on Carotid Atherosclerotic Plaques

The aim of this study is to assess whether high intensive statin therapy could regress carotid atherosclerotic plaques as determined by High-Resolution Contrast Enhanced Magnetic Resonance imaging (CE-MRI).

Enrolled patients have a baseline CE-MRI examination for screening carotid atherosclerotic plaques and are randomized to either low dose of Rosuvastatin (5mg) group or high dose of Rosuvastatin (20mg) group. After 26 weeks, all patients received CE-MRI examination again and each pair of baseline and follow-up CE-MRI assessments was analyzed in a blinded fashion. Moreover, lipid level and major adverse cardiovascular events are also evaluated during follow-up.


Eligibility Criteria:
Inclusion Criteria:

-Patients with coronary artery disease or carotid atherosclerotic plaque or hyperlipideimia or old myocardial infarction

Exclusion Criteria:

* Planning coronary stenting
* Heart failure
* Uncontrolled hypertension（≥200/110mmHg)
* Uncontrolled diabetes mellitus (HbA1C≥9.5%)
* Hepatic insufficiency
* Renal dysfunction
* Cancer
Vinflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer

This clinical trial involves the administration of the chemotherapeutic medication vinflunine. Vinflunine is not approved by the FDA and is experimental in the treatment of extensive small cell lung cancer. The purpose of this research trial is to study the effectiveness of vinflunine in patients with relapsed extensive small cell lung cancer, evaluate the toxicity, and evaluate how long the response to this drug lasts.

Eligible patients will receive vinflunine as a 15-20 minute intravenous (IV)infusion once every three weeks (21 days). This three week treatment period is called a cycle. Patients whose cancer has not grown or if it has decreased in size may receive up to 6 cycles of vinflunine. Evaluation will be conducted every other cycle.

Eligibility Criteria:
Inclusion Criteria:

* Small cell lung cancer with progression after one previous chemotherapy or chemotherapy/radiation therapy regimen
* Measurable or evaluable disease
* Able to perform activities of daily living with minimal assistance
* Adequate hematological, liver, and kidney function
* Must give written informed consent prior to entry

Exclusion Criteria:

* CNS involvement
* Serious active infection or underlying medical condition
* Significant history of uncontrolled cardiac disease
Investigating HPV Vaccination Uptake in Adults Aged 18-35 Seeking Care at a Health Clinic in Rural Mississippi

A study evaluating HPV vaccine uptake among unvaccinated patients between the ages of 18 and 35 of a mobile health clinic serving the Mississippi Delta.

This study is intended to serve several purposes. The first is to determine whether patients between the ages of 18 and 35 visiting a mobile health clinic or brick and mortar clinic in the Mississippi Delta who have not received the HPV vaccine or have not completed the vaccine series are receptive to receiving it while seeking care. The second purpose is to determine whether those patients who initially decline the HPV vaccine are interested in receiving it after being counseled about HPV and the potential effects of the virus. The third purpose is to assess whether there is a statistically significant difference between the type of visit people who opt to receive the vaccine are making to the clinics. Finally, the knowledge, attitudes, and perceptions around HPV and the HPV vaccine will be assessed via group interviews with eligible participants at the conclusion of the study.

The study also includes two secondary objectives. The first is to assess whether adults who are not vaccinated against HPV are interested in receiving it. The second is to assess whether adults accurately recall whether they received a specific vaccine during childhood. The implications from these two objectives have the potential to influence policy changes regarding vaccine catch-up among adults and health communication practices as young adults transition out of pediatric care.

Anyone between the ages of 18 and 35 whose vaccination status can be verified is eligible to be enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 18 and 35 and have a verified vaccine record that shows they were not vaccinated with the HPV vaccine or have not had a complete series of the vaccine before their visit.

Exclusion Criteria:

* patients who have been vaccinated against HPV
* patients under 18 and over 35
* patients whose vaccine records cannot be verified
Direct Anterior Versus Posterior Total Hip Arthroplasty Surgical Approaches

Hip replacement is a common surgical procedure performed to relieve the pain and disability. In general, the surgery consists of replacing the diseased or damaged joint surfaces of the hip with metal and plastic components shaped to allow continued motion of the hip. Surgeons may perform this operation in several different ways. The purpose of this study is to compare two different methods of performing total hip replacement. The investigators hypothesize that subjects treated with the anterior approached may show improved function during the early postoperative period, but that no differences in pain or function will be present after the first postoperative year.

In this study, patients that have elected to have hip replacement and consented to participate in the study will be randomized to have his or her hip replaced using one of two surgical techniques. Subjects will be randomized to be implanted using either an anterior or posterior approach. With the anterior approach, the study surgeon will use an incision that is on the front of the hip, and with the posterior approach, the incision will be more on the backside of your hip. The study surgeon has done more than 300 total hip replacements with both of these techniques.

A baseline assessment will be conducted before hip replacement surgery that includes x-rays, functional tasks like getting up from a chair and stepping down a step, and three questionnaires about the hip, the subject's general health, and how well the subject is able to function. Also, subjects will be required to return to the clinic at several time points after surgery for follow-up visits. Follow-up visits will include hip assessments and questionnaires, as well as follow-up hip x-rays. The follow-up visits will be 6 weeks, 3 months, 1 year, 2 years, 5 years, 7 years, and 10 years after hip replacement surgery. These follow-up visits are part of the study surgeon's normal routine for hip replacement patients, and are not extra visits as a part of this study.


Eligibility Criteria:
Inclusion Criteria:

* Between ages of 18 and 85
* End stage hip joint degeneration
* Has elected to undergo primary total hip arthroplasty

Exclusion Criteria:

* Undergoing revision arthroplasty
* Inflammatory or rheumatoid arthritis
* Patients with confounding medical conditions that are not expected to survive for the duration of follow-up (10 years)
* Body Mass Index greater than 40 kg/m2
* Age \< 18 or \> than 85
* Previous ipsilateral hip surgery including arthroscopic procedures
Oral Bioavailability,and Food Effect Study and Single Ascending Dose PK Study in Healthy Male Volunteers

This 2-part study will assess the effect of formulation and food on the pharmacokinetics of Indoximod in healthy volunteers. Part 1 is an open-label, 3-period, 6-sequence study. Participants will receive single doses of Indoximod base or salt formulation, in the fasted or fed state. Part 2 is a randomized single ascending dose study of indoximod salt formulation to characterize the PK profile and determine the safety and tolerability of each dose in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects 18 to 55 years of age, inclusive.
* Body mass index (BMI) of 18.0 to 30.0 kg/m2, and a minimum weight of 50.0 kg.
* Non-smoker for at least 3 months prior to Screening.
* Male subjects with female sexual partners of childbearing potential must be using and willing to continue using medically acceptable contraception
* Signed and dated written informed consent

Exclusion Criteria:

* History or presence of any clinically significant abnormality, illness, or disease which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or influence the validity of the results of the study.
* Subjects with autoimmune conditions, inflammatory bowel disease, rheumatoid arthritis, and/or subjects who have undergone an organ transplant.
* Self-reported history of substance or alcohol dependence within the past 2 years, and/or has ever participated or plans to participate in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence.
* Any medical/surgical procedure or trauma within 4 weeks of the first study drug administration or planned within 1 month of study completion.
* Positive urine drug screen.
* Positive breath alcohol test.
* Evidence of clinically significant hepatic or renal impairment
* Inability to fast for a minimum of 14 hours.
* Inability to swallow large capsules/tablets.
* Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
* Donation or loss of more than 500 mL whole blood within 1 month preceding entry into the Treatment phase and throughout the study.
* Difficulty with venous access or unsuitable or unwilling to undergo catheter insertion.
* History of severe allergic reaction (including anaphylaxis) to any substance, or previous status asthmaticus.
* Treatment with an investigational drug within 5 times the elimination half-life, if known (eg, a marketed product), or within 30 days (if the elimination half-life is unknown) prior to first drug administration or is concurrently enrolled in any research judged not to be scientifically or medically compatible with this study.
Chronic Pain Self-Management With Integrative Yoga Therapy (IYT)

The purpose of this study was to evaluate efficacy of chronic pain self-management program in community settings to adopt Integrative Yoga Therapy (IYT).


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old.
* having a chronic pain of more than 3 months of duration, no matter the aetiology.
* Capable of understanding and giving written informed consent.
* Significant levels of distress and disability related to the pain at the beginning of treatment

Exclusion Criteria:

* Intelectual disability or cognitive impairment
* Planning to move out of area
* Serious mental illness
* Drugs or substance abuse in the last 6 months
* Post surgery or scheduled for surgery
* Cancer related pain