cyrilzakka/clinical-trials huggingface dataset:
Study of 68Ga /131I SGMIB-ZT-199 PET Imaging Targeting HER2-positive in the Diagnosis of Metastatic Breast Cancer

To evaluate the safety, biodistribution, radiation dosimetry, and uptake in tumor lesions of patients with Her2-positive metastatic breast cancer after injection of \[131I\]/\[68Ga\]SGMIB-ZT-199.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients.

  1. Women aged between 18 and 75 years old.
  2. Patients with breast cancer confirmed by histological examination or imaging.
  3. HER2 positive diagnosis confirmed by puncture by immunohistochemistry or fluorescence in situ hybridization (HER2 positive is defined as immunohistochemistry result of 3+ (IHC 3+); or immunohistochemistry result of 2+/positive in situ hybridization result (IHC 2+/ISH+)).
  4. Renal function: serum creatinine less than or equal to the upper limit of the normal range; electrocardiogram: no significant abnormalities.
  5. Patients of childbearing age can cooperate with contraception.
  6. Willing and able to cooperate with all items of this study.

Exclusion Criteria:

* Subjects meeting any of the following criteria will be excluded from the study:

  1. Severe hepatic or renal insufficiency;
  2. Participation in another study protocol or clinical care within the past year that has resulted in radiation exposure exceeding an effective dose of 50 mSv in addition to the radiation exposure expected from participation in this clinical study.
  3. Participation in this study is considered unsuitable by other investigators.
  4. Pregnant women and other groups unsuitable to receive radiation.
  5. Alcohol allergy, etc.
Preperitoneal Analgesia Versus Epidural Analgesia After Open Pancreaticoduodenectomy

This is a prospective randomized open-label noninferiority trial that compares thoracic epidural analgesia and continuous preperitoneal analgesia after open pancreaticoduodenectomy.

In the Enhanced recovery after surgery (ERAS) program of pancreaticoduodenectomy (PD), thoracic epidural analgesia (or epidural analgesia) was considered to be a key analgesic method because it not only effectively controls pain, but also lowers insulin resistance and helps restore bowel movement. However, epidural analgesia can cause a number of side effects despite of effective pain control. Epidural analgesia reduces peripheral vascular resistance by blocking sympathetic nerves with local anesthetics and may cause hypotension and decreasing heart rate. In addition, it can cause orthostatic hypotension, which can interfere with early ambulation after operation. In rare cases, there are potential complications of epidural abscess, meningitis, and epidural hematoma.

Continuous peritoneal analgesia using local anesthetics has recently been used as an alternative analgesic to epidural analgesia in open abdomen surgery. This is easier to perform than epidural analgesia and is known to have fewer side effects. Recently, a non-inferiority comparison study have revealed that peritoneal analgesic was not inferior to epidural analgesia in terms of pain control. However, this study included a variety of operations other than PD, and most of the incisions were substernal, not midline. In addition, the method for mounting the epidural catheter was not described. The failure rate of the epidural catheter was reported to be 15%.

The investigators will examine the effect of continuous peritoneal analgesic postoperative pain control in patients undergoing open PD to improve postoperative pain management and to create an our own ERAS program. To this end, The investigators will test non-inferiority between epidural analgesia and peritoneal analgesia.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Disease of periampullary lesions
* Elective open pancreaticoduodenectomy (PD): PD or pylorus preserving pancreaticoduodenectomy (PPPD)
* Midline incision
* Written informed consent : ability to understand and the willingness to sign a written informed consent
* Performance status (ECOG scale): 0-1 at the time of enrollment
* Physical status (ASA) : 1-2 grade

Exclusion Criteria:

* History of any abdominal surgery (except laparoscopic appendectomy, laparoscopic/robotic cholecystectomy, laparoscopic/robotic obstetrics and gynecology surgeries,Cesarean section, laparoscopic/robotic prostate surgery)
* Emergency operation
* History of chronic pain
* Chronic use of opioid, analgesics, anti-depressant, anti-epileptics (\>1year)
* Alcoholics
* Impossible to control PCA d/t delirium, cognitive impairment
* Contraindication for epidural analgesia
* Patients with coagulopathy (INR\>1.5, Prothrombin time\>1.5, platelets \<80x10\^9perL) or anti-coagulants
* Hypersensitive to fentanyl and ropivacaine
* Need other organ resection (ex. Liver, colon)
* Intubation
Effect of Antibiotics on Gut Microbiome and Plasma Metabolome

In recent years it has been observed that the gut microbiome can produce metabolites into systemic circulation and thus have important health effects even outside the gastrointestinal system. These metabolites may play a role in the pathogenesis of common public health problems such as diabetes, obesity and cardiovascular disorders. Modern techniques of mass spectrometry-based metabolomics from peripheral blood and gut metagenome sequencing now enable detailed examination of these processes. Using samples from the FINRISK 2002 cohort, collected by the National Institute for Health and Welfare, we are currently determining the gut microbiome and plasma metabolome from \> 7000 participants with 15 years of follow-up for various health outcomes. This is one of the largest materials of its kind world-wide. The design does not, however, allow us to draw causal conclusions on the roles of gut bacteria in the composition of plasma metabolome. To enable conclusions which go beyond statistical associations, we now propose an extension to the FINRISK 2002 study, where we alter the gut bacteriome with a short course of antibiotics and then examine whether a change in plasma metabolomics profile will follow. At the same time the trial will give important novel information about the effects of commonly used antibiotics on gut bacteriome and on general health.


Eligibility Criteria:
Inclusion Criteria:

* Prior participation in the FINRISK 2002 survey and current residence in Helsinki metropolitan area.
* Age range 40-74 years among men and 50-74 years among women.

Exclusion Criteria:

* Known allergy to any antibiotic
* A course of antibiotic during the past year
* Acute infection
* Any major illness (history of myocardial infarction, stroke, diabetes, liver or kidney disease, cancer, psychiatric disease). Uncomplicated hypertension is allowed. Likewise, statin treatment and women's hormone replacement therapy are allowed.
Bacterial Vaginosis Carriage in Early Pregnancy and Preterm Delivery in Martinique, F.W.I

Preterm delivery is a public health priority in Martinique, a French oversees territory located in the Caribbean, with a rate of 10,5% substantially higher than in Continental France (7,5%). Bacterial vaginosis is an imbalance of vaginal flora known to be associated with preterm delivery risk. Studies driven in the United States have pointed out that 50% of the excess in preterm birth rate observed in Afro-American population compared to Caucasian population may be attributable to infection. Bacterial vaginosis appears much more prevalent in our population than in Continental France (approximatively 30% versus 7%) and may constitute an explanation to the discrepancy in preterm delivery rate.

Bacterial vaginosis during pregnancy is considered as a risk factor for preterm birth since the 1990's. A meta-analysis realized in 2003 found an Odds ratio of 2.4 for preterm delivery among women with bacterial vaginosis carriage, culminating at 7.5 when carriage before 17 weeks gestation was considered. Preterm delivery is a pregnancy complication known to be more prevalent among patients of African descent. Various hypothesis have been tested to account for this observed discrepancy and several authors consider that up to 50% of the difference in preterm delivery rate between Afro-american and Caucasians may have and infectious origin, with up to 30% attributable to a very different bacterial vaginosis carriage among patients of various ethnic origin. Several factors may interfere in the link observed between bacterial vaginosis and preterm delivery, which are also unevenly distributed among women of different ethnic origin. Exposure to stress, low socio-economic status, single marital status or low access to prenatal care are among those factors. Thus analyzing a relation between bacterial vaginosis and preterm delivery mandates to control for such factors. The present study will proceed to a vaginal sampling before 17 gestational age (GA) to diagnose a bacterial vaginosis through the Nugent score which is the standard diagnostic method for this pathology. At the same time, a written survey concerning stressful events in the past 12 months is submitted to volunteer patients in order to use the social readjustment rating scale by Holmes and Rahe and to account for the role of stress as a potential confounding factor. Socio-demographic data, obstetrical history and complications during pregnancy were also recorded and patients followed-up prospectively until delivery. Caregivers were blinded to the results of initial vaginal sampling. No alteration of the normal pregnancy follow-up was required by the study design.

Eligibility Criteria:
Inclusion Criteria:

* All women followed-up since the beginning of pregnancy in the study center and supposed to deliver in this same center

Exclusion Criteria:

* Previous preterm delivery,
* Previous late abortion,
* Multiple pregnancy,
* Cervical cerclage before inclusion
Variable Approaches of Intradiscal O3-O2 Injection

Cost Intradiscal injection of ozone-oxygen mixture (O3-O2) which offers a rapid onset amelioration of symptoms, with a sustained duration pain relief in low back pain.

Does change of injection approach make a difference?

Low back pain (LBP) mostly is induced by disc herniation (DH), or degeneration and has a burden upon social and economic aspects of life. Medical and or surgical interventions have been used to resolve this problem, but one of the newly introduced is the minimally invasive low cost Intradiscal injection of ozone-oxygen mixture (O3-O2) which offers a rapid onset amelioration of symptoms, with a sustained duration pain relief.

A lot of injection approaches are available, but which offers the best results, is the question.

Eligibility Criteria:
Inclusion Criteria:

* radicular leg pain
* low back pain
* non-responsive to conservative treatment

Exclusion Criteria:

* patient refusal
* infection at injection site
* coagulopathy
* uncontrolled or degenerative spine disease
* pregnancy
* multilevel disk involvement
Gingival Crevicular Fluid and Placental Tissue Levels of Interleukin-17 as a Possible Marker for Preterm Labor in Patients With Chronic Periodontitis

This case control-study measures the levels of Interleukin-17 in gingival crevicular fluid and placental tissue samples of pregnant females as a possible marker in determining whether or not an association exists between chronic periodontitis and preterm labor. Interleukin-17 is a pro-inflammatory cytokine whose levels have been proven to increase in periodontal disease.


Eligibility Criteria:
Inclusion Criteria:

1. Within the age range of 18-35 years
2. Free of any systemic diseases as referenced from Burket's Oral Medicine health history questionnaire (Glick2008)
3. Spontaneous normal term birth at ≥37 weeks of gestation without any obstetrical or medical complications
4. Spontaneous preterm birth (PTB) at \<37 weeks of gestation after uterine contraction or rupture of membranes (Keelan1999)

Exclusion Criteria:

1. History of medications that may affect the study outcome, such as: current use of systemic corticosteroids or antibiotics for at least one month
2. Genital and urinary tract infections
3. Existing hypertension and diabetes mellitus before pregnancy, autoimmune disease, asthma, and chronic renal disease
4. Multiple pregnancies, cervical cerculage, abnormal placentation, past history of preterm delivery, or antepartum hemorrhage
5. Low or high maternal body mass index
Study to Evaluate and Compare Safety and Pharmacokinetics of the HCP1004 and VIMOVO 500/20mg in Healthy Korean Male

The purpose of this study is to Evaluate and Compare Safety and Pharmacokinetics of the HCP1004 and VIMOVO 500/20mg in Healthy Korean Male


Eligibility Criteria:
Inclusion Criteria:

* BMI: 18.0 - 27.0 kg/m2
* Willingness to sign the written Informed Consent Form

Exclusion Criteria:

* Evidence of clinically relevant pathology
* History of relevant drug and food allergies
* Positive screen on drugs of abuse
* Participation in a drug study within 60 days prior to drug administration.
Extracorporeal Therapy for the Removal of Myoglobin Using the CytoSorb in Patients With Rhabdomyolysis

Prospective, randomized non-blinded, controlled study to assess the feasibility of the CytoSorb as an adjunct to the standard of care in patients with rhabdomyolysis requiring renal replacement therapy.


Eligibility Criteria:
Inclusion Criteria:

* Subject is age 18-80
* Subjects present with rhabdomyolysis
* Subject requires renal replacement therapy and has undergone adequate volume resuscitation
* Subject is willing to comply with specified follow up requirements

Exclusion Criteria:

* Subject or their legal guardian either declines or cannot give informed consent
* Subject is pregnant
* Subject has been previously enrolled in this clinical study
* Comorbid condition that may limit survival to ≤14 days
* Comorbid condition that could confound study results
* Subjects who are receiving immunosuppressive therapy
Clinical Trial Testing Buzzy Bee vs Vapocoolant During IV Placement

The purpose of this study is to compare the anxiety and pain levels of patients when using Buzzy with ice, Vapocoolant, and placebo when inserting IV's line for IV fluids and/or phlebotomy in pediatric patients in the pediatric emergency department.


Eligibility Criteria:
Inclusion Criteria:

* Need IV's line placement for IV fluids and/or phlebotomy

Exclusion Criteria:

* patients sensitive to cold i.e. Raynaud's
* critically ill patients
* mentally challenged patients
* GCS\< 15
* Patient with altered sensation
* Patients needing more than one attempt at IV placement
Changes in Refractive Error in Patients With Both Partially Refractive Esotropia and Amblyopia

To investigate changes in refractive errors and evaluate clinical outcomes of strabismus surgery in patients with both amblyopia and partially refractive esotropia (PAET).Amblyopic patients with PAET were enrolled. Non-amblyopic patients with full refractive accommodative esotropia (RAET) were included in the study as a control group. Preoperative and postoperative best corrected visual acuity (BCVA), spherical equivalent (SE), astigmatism, stereoacuity and deviations at near and distance were evaluated and statistically compared in the patient group. The mean BCVA, SE, astigmatism were compared between the patient and the control groups.

Purpose: To investigate changes in refractive errors and evaluate clinical outcomes of strabismus surgery in patients with both amblyopia and partially refractive esotropia (PAET).

Material-Method: Amblyopic patients with PAET were enrolled. Non-amblyopic patients with full refractive accommodative esotropia (RAET) were included in the study as a control group. Preoperative and postoperative best corrected visual acuity (BCVA), spherical equivalent (SE), astigmatism, stereoacuity and deviations at near and distance were evaluated and statistically compared in the patient group. The mean BCVA, SE, astigmatism were compared between the patient and the control groups.

Eligibility Criteria:
Inclusion Criteria:

amblyopic children with partially refractive accommodative esotropia as study group non- amblyopic children with fully refractive accommodative esotropia as control group

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Exclusion Criteria:

Systemic diseases Neurological disorders and diseases Additional ocular diseases
Comparative Physiologic Technology Study

This study is designed to test two hypotheses:

1. The PADnet+ testing system produces clinically equivalent results as the Parks Flo-Lab testing system in a group of patients referred for evaluation of PAD of the limbs when performed by a Registered Vascular Technologist (RVT).
2. The PADnet+ testing system produces clinically equivalent results when the testing is repeated on the above patients and performed by staff specifically trained on the use of the PADnet+ system but are not vascular technologists nor hold the RVT certification.


Eligibility Criteria:
Inclusion Criteria:

* All patients referred to the MGH Vascular Labs for diagnostic testing for PAD

Exclusion Criteria:

* None
Safety and Tolerability of MK-5478 in Participants With Hypertension (5478-001)

This is a two part introductory clinical trial with MK-5478. Part I will evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics of MK-5478 in young, healthy males. Part II will evaluate the safety, tolerability and pharmacodynamic effects of MK-5478 in participants with hypertension. The primary hypothesis is that single oral doses of MK-5478 are sufficiently safe and well tolerated.


Eligibility Criteria:
Inclusion Criteria:

Part I:

* Is a male between 18 to 50 years of age
* Is in good health
* Is a non-smoker

Part II:

* Is male of non-child bearing potential between 18 and 50 years of age
* Has hypertension (high blood pressure)

Exclusion Criteria:

Part I and Part II:

* Has a history of stroke, seizures or major neurological disorder
* Has a history of cancer
* Has a history of any cardiovascular disease
* Is unable to refrain from the use of any prescription or non-prescription drugs
* Consumes excessive amounts of alcohol or caffeine
* Has had major surgery, donated blood or participated in another investigational study in the past 4 weeks
A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults

The primary objective of the study is to evaluate the effect of casirivimab+imdevimab, compared with placebo, in preventing symptomatic SARS-CoV-2 infection in immunocompromised participants.

The secondary objectives of the study are:

* To evaluate the safety and tolerability of repeated SC injections of casirivimab+imdevimab in the study population
* To characterize concentrations of casirivimab and imdevimab in serum over time
* To assess the immunogenicity of casirivimab and imdevimab


Eligibility Criteria:
Key Inclusion Criteria:

1. Meets ≥1 of the following criteria:

   * Is immunocompromised, including people with transplant, who have cancer, primary immunodeficiencies, HIV, rheumatological disease, autoimmune disease, multiple sclerosis OR
   * Currently taking immunosuppressant drugs
2. Have been fully vaccinated against COVID-19 or deemed medically ineligible to receive full course of vaccine
3. Has documented negative serology/antibody response in an anti-SARS-CoV-2 spike protein IgG clinical test or ≤50 U/mL on the Elecsys® SARS-CoV-2 S Total Ig test
4. Tested negative for the COVID-19 virus within 72 hours prior to randomization

Key Exclusion Criteria:

1. Weighs \<40 kg (only applies to participants ≥12 to \<18 years of age)
2. Has any signs or symptoms consistent with COVID-19
3. Past COVID-19 infection within 90 days prior to randomization
4. Planned use of any investigational, authorized, or approved vaccine for COVID-19 within 90 days of the last dose of study drug
5. Prior, current, or planned use of any of COVID-19 convalescent plasma, other monoclonal antibodies against SARS-CoV-2 or any COVID-19 treatment
6. Is planned to begin immunoglobulin (IVIG) or immunoglobulin (SCIG) therapy, is planned to have a change to existing IVIG or SCIG, or has been on a chronic stable dose of their IVIG or SCIG regimen for less than 90 days prior to screening
7. Has any known active acute respiratory infection
8. Has persistent (refractory to treatment for ≥14 days) bacterial or fungal infection
9. Has known allergy or hypersensitivity to components of the study drugs

NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply
Assessment of the Glycemic Responses to Nutritional Products

This study assesses the glycemic responses to nutritional products. During a study visit fasted subjects will consume one serving of the reference product or the test product. Capillary blood samples will be taken at baseline and at several time-points over a 2-hr period. Several nutritional products will be tested over time.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 65 years
* Body mass index (BMI) between 18.5 and 27 kg/m²

Exclusion Criteria:

* Known history of gastrointestinal disease, bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), or any condition which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2)affect the results.
* Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
* Major trauma or surgical event within 3 months of screening.
* Known intolerance, sensitivity or allergy to test products.
* Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.).
* History of cancer in the prior two years, except for non-melanoma skin cancer.
Platelet-rich Fibrin With 1.2% Rosuvastatin in Chronic Periodontitis Treatment

The present study is designed to evaluate the combined efficacy of Platelet Rich Fibrin (PRF) and 1.2% Rosuvastatin (RSV) with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis patients

ABSTRACT Background: Regenerative periodontal therapy encompasses the use of various bioactive agents that are not only inflammo-modulatory but also osteoclast-inhibitory or rather, osteostimulative. The hypolipidaemic Statin group of drugs, particularly Rosuvastatin (RSV), are known to be associated with alveolar bone formation and periodontal improvements. Platelet analogues like Platelet rich fibrin (PRF), being rich sources of growth factors, have also come into widespread periodontal regenerative use. The aim of the study is to evaluate and compare the efficacy of open-ﬂap debridement (OFD) with or without PRF or PRF + 1.2% RSV gel in the treatment of intrabony defects (IBDs) in chronic periodontitis (CP) patients.

Methods: Ninety individuals with a total of 90 IBDs were randomly assigned to one of the 3 treatment groups: 1) OFD alone, 2) OFD + PRF and 3) OFD + PRF + 1.2% RSV gel placement. Plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment (CA) level and IBD depth were recorded at baseline and at 9 months post-operatively.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy with CP diagnosis16 having probing depth (PD) ≥5mm, clinical attachment (CA) level ≥3mm and vertical bone loss ≥3mm on intraoral periapical radiographs (IOPAR) without any antibiotic or periodontal therapy in the last 6 months.

Exclusion Criteria:

* History of statin allergy, statin therapy, any systemic condition or medication altering the periodontal condition, immune-compromised state, hematologic disorders, insufﬁcient platelet count (\<200,000/mm3), aggressive periodontitis, substance/tobacco abuse and lactating and pregnant females.