cyrilzakka/clinical-trials huggingface dataset:
Comparison Study of Different Tumor Biopsy Method for Sentinel Lymph Node Biopsy in Breast Cancer

Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cance, and the identified number of sentinel lymph nodes determines its accuracy for axillary status. Retrospective study indicated that preoperative tumor biopsy results in more detected sentinel lymoh nodes. The clinical trail is designed to compare the effect of three tumor biopsy methods (preoperative vacuum-assisted biopsy, core needle biopsy, and intraoperative excisional biopsy) for sentinel lymph nodes.

OBJECTIVES:

Compare the identification rate of sentinel lymph node in breast cancer patients with different tumor biopsy methods.

Evaluate the false-negative rates of sentinel lymph nodes in patients with different tumor biopsy methods.

OUTLINE:

The patients were randomly divided into three group, vacuum-assisted biopsy, core needle biopsy, and intraoperative excisional biopsy. Preoperative vacuum-assisted biopsy and core needle biopsy were performed in 10 days before the final surgery. All patients received dual tracer (radiolabeled colloid and blue dye) guided SLNB.

Eligibility Criteria:
Inclusion Criteria:

* clinically lymph node negative breast cancer patients T1-T3

Exclusion Criteria:

* history of breast cancer locally advanced breast cancer and metastatic breast cancer proven axillary lymph node metastasis history of axillary excisional or incisional biopsy, or dissection history of neoadjuvant chemotherapy pregnancy non-consented patients
Specific Enteral Nutrition in Malnourished, Dialysis Patients With Chronic Kidney Disease. Efficacy, Safety, Quality of Life

The objective of this unblinded study is to assess the nutritional effects of a 12 weeks administration of the specific enteral nutrition (SEN) RealDiet®Renal pockets, as well as the impact on the patients' quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease patient on hemodialysis for at least 3 months, with a minimum of three hemodialysis sessions of 4 hours per week
* Patients aged 18 years
* Written, free and informed consent given by the Patient
* Patient insured under the social security system or equivalent
* Patients who did not receive enteral nutrition during the 3 months preceding inclusion ; taking an oral nutritional supplement, or per-dialytic parenteral nutrition or total parenteral nutrition is not a criterion of non-inclusion
* Patient in a state of malnutrition

  * defined by the presence of at least 3 out of 5 of the following criteria :

    * weight loss greater than 10% observed in the last six months
    * serum albumin \<35 g / l
    * serum Prealbumin \<300 mg / l
    * BMI \<20
    * NPNA \<1 g / kg / day for 2 consecutive months

and

* presenting

  * food intake \<20 kcal / kg / day or
  * failure of other nutritional care methods, namely, oral nutritional supplements and / or peridialytic parenteral nutrition, or total parenteral nutrition
  * lack of compliance after one month, to the nutritional care methods mentioned above. • Patients for whom the decision to prescribe enteral feeding was previously taken

Exclusion Criteria:

* Patients with a history of intolerance to enteral feeding
* Index Kt/Veq (balanced) \< or = 1.2 or index Kt/Vsp (single pool) \< or = 1.4 according to the method used
* Patients with a disease compromising the short-term (4-6 months) prognosis (cancer or other disease in the terminal phase)
* Pregnant Patient
* Patient with a known allergy to at least one of the following : milk protein, soy, fish
* Patient whose digestive tract is not functional or patient in shock
* Patient protected under guardianship
* Patient in exclusion period after participation in another clinical trial.
Rewarding Sexually Transmitted Infection (STI) Prevention and Control in Tanzania

This project evaluates the effect of a combined economic and psycho-social intervention to reduce risky sexual activity and its consequences. The main hypothesis to be tested is that risky sexual activity and resulting sexually transmitted infections (STIs) can be reduced through an intervention of counseling, regular STI testing, and positive reinforcement using cash rewards. The intervention is being implemented in a population of young people in rural Tanzania where more conventional behavioral change interventions have had limited effect in battling a generalized HIV epidemic.


Eligibility Criteria:
Inclusion Criteria:

* Plan to live in study area for next 12 months

Exclusion Criteria:

* Pregnant
A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma

The purpose of this study is to define the safety of Ciltacabtagene Autoleucel (Cilta-cel) and Talquetamab in participants with high-risk multiple myeloma (MM).


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of MM according to the IMWG diagnostic criteria and is defined as a measurable disease at screening
* Cohort 1: Received at least 3 prior lines of antimyeloma therapy and have undergone greater than or equal to (\>=) 1 complete cycle of the therapy
* Cohort 1: Documented evidence of progression of disease (PD) or failure to achieve a response to the last line of therapy
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Participant of childbearing potential (POCBP) must have a negative pregnancy test using a highly sensitive β-human chorionic gonadotropin (hCG) serum pregnancy test at screening

Exclusion Criteria:

* Cohort 1: Prior treatment with chimeric antigen receptor T cell (CAR-T) therapy directed at any target or any prior B cell maturation antigen (BCMA)-directed therapy/prior G protein-coupled receptor family C Group 5 member D (GPRC5D)-directed therapy
* Cohort 1: Received either of the following: An allogenic stem cell transplant within 6 months before apheresis/first dose of study drug and no immunosuppressive medications administered before the start of study treatment. And secondly, received an autologous stem cell transplant less than (\<)12 weeks before apheresis/first dose of study treatment
* Receive live, attenuated vaccine within 4 weeks of enrollment
* Toxicity from previous anticancer therapy not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
* Stroke, transient ischemic attack, or seizure within 6 months of signing informed consent form
Prescription-based Fluid Management Versus Usual Care in Critically Ill Patients on KRT Trial in UK

The PROBE Fluid UK randomised controlled trial compares a protocol-based fluid removal strategy with usual care in critically ill patients with acute kidney injury receiving kidney replacement therapy.

Severe acute kidney injury (AKI) in the intensive care unit (ICU) is almost uniformly complicated by fluid accumulation, often leading to fluid overload. Congestion resulting from fluid accumulation is believed to contribute to organ failure. Removal of excess fluid is a central component of dialysis treatment, also known as kidney replacement therapy (KRT). However, there remain important knowledge gaps in our ability to remove excess fluid effectively and safely. If fluid is removed too slowly, fluid overload and its complications persist for longer. If fluid is removed too fast during KRT, patient's blood pressure may drop (ie hemodynamic instability may occur) which may precipitate complications.

The optimal fluid management strategy is currently unknown.

The PROBE Fluid UK study is a randomized clinical trial comparing a protocol-based fluid removal strategy with usual care in critically ill patients with AKI receiving KRT. The fluid management protocol is intended to achieve neutral or negative daily fluid balance by both preventing and treating fluid accumulation.

The primary objective of this trial is to determine whether the intervention results in a difference in cumulative fluid balance from day of randomization to 5 days later. Secondary outcomes will include short-term patient outcomes, safety outcomes, and health resource utilization related to KRT delivery.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients aged ≥18 years
2. Admitted to the intensive care unit
3. Acute kidney injury defined by the KDIGO criteria
4. Planned initiation of KRT within 12 hours or the receipt of KRT for AKI for ≤48 hours

Exclusion Criteria:

1. Lack of commitment to maintain kidney, pharmacologic or respiratory support at the time of screening, or probable transition to comfort care within 48 hours according to the treating clinician
2. Probable discharge from the ICU within 48 hours according to treating clinician
3. Severe burn injury (\>10% of body surface area)
4. Severe abnormality in serum sodium (\>155 or \<120 mmol/L)
5. Important ongoing fluid losses are present and/or are expected to require continued maintenance IV fluids during the next 48 hours
6. The clinical care team believes that the proposed intervention is inappropriate
Study to Assess the Intrapulmonary Pharmacokinetics of SPR859 by Comparing the Plasma, Epithelial Lining Fluid (ELF), and Alveolar Macrophages (AM) Concentrations Following the Oral Administration of Five Doses of SPR994 in Healthy, Nonsmoking Volunteers

To evaluate the intrapulmonary pharmacokinetics (PK), including ELF and AM concentrations, of SPR859 (tebipenem) compared to plasma concentrations of SPR859 (tebipenem) (the active moiety in plasma of the prodrug SPR994) in nonsmoking healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Adult males or female subjects, between 18 and 55 years of age (both inclusive) at the time of screening
* BMI ≥ 18.5 and ≤ 32 (kg/m2) and weight between 55.0 and 100.0 kg (both inclusive)
* Willing and able to provide written informed consent; Willing and able to comply with all study assessments and adhere to the protocol schedule
* Medically healthy without clinically significant abnormalities as assessed by the Investigator based on screening medical history, physical examination, vital signs, 12-lead ECG, hematology, biochemistry and urinalysis
* Have suitable venous access for blood sampling

Exclusion Criteria:

* History of seizure disorders
* Positive urine drug, alcohol or cotinine testing at screening or check-in (Day -1)
* Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (HCV);
* Positive testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening;
* Presence of the following symptoms at screening or within 14 days prior to screening or Check-in (Day -1)

  1. Fever, chills or sweats (temperature of 38 °C / 100.4 °F or higher)
  2. Difficulty breathing
  3. Cough
  4. Sore throat
  5. New or recent loss of taste or smell
  6. Nausea, vomiting or diarrhea;
* Close contact with anyone who tested positive for SARS-CoV-2 infection within 14 days prior to screening or Check-in (Day -1);
* Electrocardiogram (ECG) with QTcF interval duration equal or greater than 450 msec for males and 470 msec for females
* Subjects who have any of the following abnormalities on laboratory values at screening or prior confinement including:

  1. White blood cell count \< 3,000/mm3, hemoglobin \< 11g/dL;
  2. Absolute neutrophil count \<1,200/mm3, platelet count \<120,000/mm3;
  3. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 1.5 x the upper limit of normal (ULN) for the reference laboratory;
* History of substance abuse or alcohol abuse
* Use of tobacco/nicotine- or marijuana-containing products (including vaping products) within 12 months prior to screening;
* Known history of clinically significant hypersensitivity reaction or anaphylaxis to any medication
Dominican Republic Mission Cost Analysis

Expenditures on material supplies and medications constitute the greatest per capita costs for surgical missions. We hypothesized that supply acquisition at nonprofit organization cost would lead to significant cost-savings compared to supply acquisition at US academic institution costs from the provider perspective for hernia repairs and minor procedures during a surgical mission in the Dominican Republic.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to the Institute of Latin American Concern Center for surgical procedure, previously screened by local healthcare workers.
* Require hernia surgery, hydrocelectomy, excision of benign cutaneous mass.

Exclusion Criteria:

* Did not require hernia surgery, hydrocelectomy, excision of benign cutaneous mass.
RevCore for in Stent Thrombosis

The purpose of this research is to collect information about how the RevCore Thrombectomy Catheter works to treat stent blockages.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Patients with stent age \> 6 weeks
3. Location of thrombosed stents in proximal lower extremity deep vein segments including at least common femoral, external iliac, or common iliac vein
4. RevCore Thrombectomy Catheter must enter vasculature
5. Willing and able to provide informed consent

Exclusion Criteria:

1. Exposed stents with broken struts, significantly deformed struts, struts protruding into the vessel
2. Stents not wall apposed
3. Stents compressed to \<10mm
4. Bilateral in-stent thrombosis
5. Congenital anatomic anomalies of the iliac veins
6. Allergy, hypersensitivity, or thrombocytopenia from heparin or iodinated contrast agents, except for mild to moderate contrast allergies for which pretreatment can be used
7. Any contraindication to anticoagulants or antiplatelets that, in the opinion of the Investigator, cannot be medically managed throughout the study period
8. Chronic non-ambulatory status
9. Known hypercoagulable states (e.g. antiphospholipid syndrome) that, in the opinion of the Investigator, cannot be medically managed throughout the study period
10. Inability to secure venous access
11. Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject
12. Current participation in another investigational drug or device treatment study
Effects of Salvinorin A in Healthy Controls

This study evaluates the effects of Salvinorin A (SA). SA is the active ingredient of the plant Salvia divinorum that is known to have been used by Mexican Indians as part of religious rituals. The purpose of this project is to understand what people experience when they consume Salvinorin A.


Eligibility Criteria:
Inclusion Criteria:

-Previous exposure to inhaled Salvinorin A (SA).
Study of Anlotinib Plus Chemotherapy as the First-line Treatment in Patients With Advanced NSCLC

Non-small cell lung cancer has the highest morbidity and mortality in China，and platinum-based chemotherapy is the standard first-line treatment for the wild-type NSCLC,however the overall survival still less than one year.Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit, which has strong effect of anti-angiogenesis.This study is aim to evaluate the efficacy and safety of the combination regimen of anlotinib plus platinum-based chemotherapy as first-line treatment for NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Age：18\~70 years;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 -2
* Subjects with histologically or cytologically confirmed locally advanced or advanced NSCLC
* EGFR\\ALK\\ROS1 wildtype or unknown,or patients with EGFR\\ALK\\ROS1 mutations but refuse to receive corresponding inhibitors' treatment
* No indications for radiation therapy
* Previously chemotherapy naive or postoperative adjuvant chemotherapy ended more than 1 year
* Subjects with at least one measurable lesion as defined by RECIST (version 1.1),which is confirmed by computed tomography (CT) scan or MRI

Exclusion Criteria:

* Small Cell Lung Cancer
* central lung squamous carcinoma along with cavum, or non-small cell lung cancer along with hemoptysis (\>50ml/day)
* Within 30 days before enrollment, the patient had used any chemotherapy drugs in the previous treatment regimen or clinical study; Or, within 14 days before the first administration of the study therapy, the patient has used any targeted anticancer drugs in the previous treatment regimen or clinical study; Or stop other experimental drugs or cancer drugs for less than five half-life of the drug
* Previous use of anti-angiogenic drugs (such as anlotinib, apatinib, bevacizumab, endostar, etc.)
* have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
* Spinal cord compression or symptomatic and untreated brain metastases (asymptomatic, stable, no need for steroid treatment for 4 weeks before study start)
* with kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus)
* Previous histories include: interstitial pneumonia, drug-induced interstitial pneumonia, radiation pneumonia requiring steroid treatment, and clinically proven active interstitial pneumonia
* get arterial/venous thrombosis within 6 months, such as cerebrovascular accidents (including temporary ischemic stoke), prevenous thrombosis, and pulmonary embolism
* Have suffered from hemorrhagic disease or coagulation dysfunction
* diagnosed with disease which will severely endanger the security of patients or influence the completion of this research
Observational Registry of Acthar Gel for Participants With Multiple Sclerosis Relapse

Acthar Gel was first approved by the Food and Drug Administration in 1952.

It has been used to treat many different illnesses, including multiple sclerosis.

This study will observe how treatment with Acthar affected the daily lives of patients who suffer with relapsing/remitting MS.

It will collect information on symptoms, recovery, treatment patterns and safety outcomes.

Acthar Gel (repository corticotropin injection) contains a non-bovine analogue of adrenocorticotropic hormone (ACTH) for intramuscular or subcutaneous use.

It was initially approved by the FDA in 1952 and is used for multiple indications.

This registry will evaluate the use of Acthar Gel for the treatment of MS exacerbations in the United States.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female ≥ 18 years of age.
2. Patient has a clinically definite relapsing form of Multiple Sclerosis according to McDonald Criteria (2010 revision).
3. Patient with an acute MS exacerbation as determined by their treating clinician.
4. Patient planning to initiate Acthar Gel for the treatment of an acute MS exacerbation.
5. Patient capable of providing informed consent.

Exclusion Criteria:

1. Patients with a diagnosis of Progressive MS.
2. Patients that require concomitant corticosteroid therapy.
3. Patients receiving experimental drug therapy.
4. Patients with a history of scleroderma, systemic fungal infections, ocular herpes simplex within prior 5 years.
5. Patient has any solid tumor malignancy currently diagnosed or undergoing therapy, or has received therapy for any solid tumor malignancy in the 5 years prior to the Enrollment Visit, with the exception of treated and cured basal cell carcinoma, treated and cured squamous cell carcinoma of the skin, and treated and cured carcinoma in situ of the cervix.
6. Patients who had recent surgery or have a history of or the presence of a peptic ulcer within 6 months prior to study entry, congestive heart failure, or sensitivity to proteins of porcine origin.
7. If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use appropriate birth control.
Accuracy of Arch Analysis in Mixed Dentition Using Digital Models Versus Plaster Ones.

Accuracy of arch analysis in mixed dentition using digital study models versus the plaster models using Tanaka and Johnston prediction equation:

Space analysis is traditionally performed by diagnostic measurements that have been obtained from plaster dental casts through measurements which might be influenced by subjective interpretation and bias when constructed.

\*So another method of diagnostically measuring study models was introduced (Digital software). This system creates digital images of dental casts with software. From the digitized models, various analyses and routine measurements could be done that might accelerate and solve many problems and difficulties associated with storage, retrieval, reproduction, communication, and breakage of conventional plaster casts.

* Taking an impressions for a mixed dentition aged children.
* Perform a measurements using Tanaka and Johnston equation for an arch analysis using a caliper and 3Shape ortho-analyzer software.
* Casts will be scanned using the 3D scanner then by using the 3shape software measurements will be held according to Tanaka and Johnstopn prediction equation.

Eligibility Criteria:
Inclusion Criteria:

* Aged range from 6-10.
* patients medically free from any syndromes that could affect the normal eruption.
* Normal radiographical findings in teeth eruption.
* Erupted lower incisors.

Exclusion Criteria:

* Extracted lower 1st permanent molar.
* congenital missing of incisors.
* Badly decayed permanent incisors or 1st molar that could compromise the measurements.
* Any sensitivity to any of the impression materials.
MVCT Imaging Pilot Study Using Helical Tomotherapy

To compare the two types of scans, the conventional CT planning scan and the tomotherapy planing scan.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing radiotherapy metallic artifact in radiation field.

Exclusion Criteria:

* Contraindication to radiotherapy
Fecal Microbiota Transplantation on Type 2 Diabetes Mellitus

The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the body's metabolism. Evidence from animal and human studies strongly support the link between intestinal bacteria and type 2 diabetes mellitus. The present clinical trial aims to re-establish a gut functionality state of intestinal flora through fecal microbiota transplantation.

We established a standard bacteria isolation from donated fresh stool in lab.Then the bacteria is transplanted to mid-gut (at least below the second part of duodenum ) through regular gastroscope. Participants in this study will be randomly assigned to receive fecal microbiota transplantation only once or traditional therapy, and accept follow-up for at least one year. Blood tests,OGTT and magnetic resonance spectroscopy will be used to assess participants at study start and at study completion.

Eligibility Criteria:
Inclusion Criteria:

Type 2 diabetes mellitus

Exclusion Criteria:

With any cause of liver disease other than fatty liver Known or suspected cirrhosis Inability or unwillingness to undergo OGTT and magnetic resonance procedures Requirement of long-term antibiotic therapy Pregnancy, breast-feeding, or plans to become pregnant