cyrilzakka/clinical-trials huggingface dataset:
Use of Mometasone Eluting Stent in Choanal Atresia

This study is to find out how well drug-eluting stents work as part of treatment for choanal atresia repair. Participants will be receiving surgical choanal atresia repair; half will get a drug-eluting stent placed, the other half will not.

Objective: To determine the utility of mometasone eluting stents in the treatment of choanal atresia.

Setting: Cincinnati Children's Hospital Medical Center (CCHMC), Division of Pediatric Otolaryngology, Head and Neck Surgery

Study Design: Randomized, single blind control trial

Methods: This study will be a randomized, prospective single-blinded control trial. Inclusion criteria will include all subjects less than 11 years of age who are diagnosed with either unilateral or bilateral choanal atresia. Following enrollment, the patients will be randomized to either a control arm (no stent) versus an intervention arm (placement of drug eluting stent). Subjects will then undergo surgical repair of the choanal atresia with either no stent or a drug eluting stent placed. Multiple postoperative nasal endoscopies will be performed to assess size which will be reviewed and graded by two independent reviewers.

Analysis: Descriptive statistical analysis and multivariate analysis will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are under 11 years old and have a diagnosis of choanal atresia will be included in this study.

Exclusion Criteria:

* Those subjects who are 11 years of age or greater or who do not have choanal atresia will be excluded.
GOELAMS SA4 Study: the Role of Fludarabine in the Treatment of Acute Myeloid Leukemia in the Elderly

In this study, patients were randomly assigned to either receive fludarabine or not (20 mg/m2/d) in addition to induction chemotherapy, consolidation chemotherapy and the 3 subsequent re-induction courses during maintenance.

Eligibility for enrollment in the study was limited to patients aged 60 to 75 years old with previously untreated de novo AML as defined morphologically by the French-American-British (FAB) classification with the exception of M3 and M7 subtypes.10,11 The bone marrow aspirate had to show at least 30 percent of nonerythroid blast cells. Patients were not eligible if they had a performance status before diagnosis of 2 or more according to the World Health Organization (WHO) grading system, congestive heart failure or abnormal left ventricular ejection fraction, severe hepatic or renal disturbances if not related to leukemia (hepatic enzymes levels over four times the normal values, serum bilirubin over 35 micromol/L, creatinine over 150 micromol/L). Patients with previous unexplained cytopenia were eligible for the study. Conversely, patients with a history of documented myelodysplastic or myeloproliferative syndrome or previously treated with chemotherapy or radiation could not enter the study. The study received in June 1996 approval from the ethics' board of the Nancy Hospital and written informed consent was given by all eligible patients before entering the study, in accordance with the Declaration of Helsinki. The enrollment period was open from November 1996 to April 2000.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 60 to 75 years old
* untreated de novo AML
* performance status less than 2

Exclusion Criteria:

* performance status more than 2
* congestive heart failure or abnormal left ventricular ejection fraction
* severe hepatic or renal disturbances
* history of documented myelodysplastic or myeloproliferative syndrome
* patients previously treated with chemotherapy or radiation
Assessment of ADC Values and Radiomics Characteristics With a MRI of the Prostate to Identify Tumor Lesions

The goal of this observational study is to assess the chance to predict prostate cancer with the analysis of specific values found in images obtained from RMmp (multiparametric magnetic resonance imaging) of patients who went through the procedure at IRCCS Azienda Ospedaliero-Universitaria hospital in the city of Bologna from September 2015 to March 2021.

The main question it aims to answer is:

- does the analysis of ADC values and radiomics values found in the RMmp images help with the detection of prostate cancer?

The radiologist involved in this observational study will enroll the participants, collect their informed consent and radiological data.

The urologist will collect the clinical data while the Anatomo-pathologist will take care of the hystological data.

The ADC values of the suspected lesions and healthy parenchyma will be extracted from the MR exams. For the evaluation of radiometric characteristics, images will first be de-identified, the downloaded and processed by the hospital's medical physicists.

The engineers at the University of Bologna, led by medical investigators, will extract the radiomic characteristics All data will be anonymised and collected in a database shared between the collaborating operational units.

Eligibility Criteria:
Inclusion Criteria:

* Presence of one or more lesions classified as PI-RADSv2.1 ≥ 3 at a prostate RMmp at the IRCCS Azienda Ospedaliero-Universitaria in Bologna
* Indication for eco-guided targeted biopsy by fusion technique integrated with systematic biopsy
* Indication for radical prostatectomy
* Participants aged 18 at the time of examination
* Obtaining informed consent.

Exclusion Criteria:

* Impossibility of performing MRI (claustrophobic or obese participants etc.) or contraindications to the execution of MRI
* Technically sub-optimal investigations for the presence of artifacts (hip prosthesis, movement of the endorectal probe, etc.)
The PLATON Network

The PLATON Network study is designed to elevate personalized therapy based on genomic tumor profiles in gastrointestinal cancer patients. Hereby, PLATON's study-design focuses on the patient's tumor molecular profiling. Within the network a web application will be developed to link clinical investigators and information on study sites, cancer patients and genetic alteration data, as well as available clinical trials at PLATON's study sites.

The PLATON Network is established as permanent open, multicenter, prospective, cohort study of patients with gastrointestinal cancer. The study design includes a study-specific biobank and a shared platform infrastructure for associated sub-studies and analysis projects.

Within PLATON results of genetic tests of different research projects like the PLATON pilot-study (NCT04484636) as well as Next-generation deep sequencing (NGS) according to local protocols will be documented - compiling genomic tumor-profiles including tumor mutational burden (TMB) and microsatellite instability (MSI).

The PLATON Network infrastructure is designed to increase the likelihood of treating the patients with an individualized therapy in available clinical studies. Therefore, molecular profiling must go hand in hand with inter-linking physicians and increasing inter-centre transparency. The feasibility of this approach will be tested in the PLATON Network, keeping in mind the vision of cancer patients receiving the best available, scientifically founded, biomarker-based care, tailored to his or her individual needs.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of hepatocellular carcinoma or intra- cholangiocarcinoma, extrahepatic cholangiocarcinoma or gallbladder carcinoma or pancreatic ductal adenocarcinoma or esophagogastric adenocarcinoma in the advanced setting (adjuvant or neoadjuvant therapy is allowed if completed 6 months prior to enrolment) and no local curative therapy available
* Standard first line therapy is planned, or patient is currently receiving first-line therapy
* Available tumor-genomic profile ( ≥50-gene panel assay; approved and assessed by central review), unless central tumor genomic profiling is done within a sub-study
* ECOG 0-2
* Life expectancy ≥ 6 months

Exclusion Criteria:

* Not able to understand all implications of study participation
* No written informed consent
* Age \< 18 years
Health-E You Efficacy Trial for Male Adolescents

This study will involve evaluating Health-E You/Salud ìTu™, a web-based, pre-visit mobile app designed to support adolescent male youth and his clinicians in discussing sexual and reproductive health (SRH) topics and care. It will test its efficacy among male patients in clinical settings using a stepped wedge cluster randomized controlled trial design.

Health-E You is a pre-visit, web-based mobile app designed to support an adolescent male youth and his clinician in discussing SRH topics and care. It is shared with an adolescent patient prior to a clinic visit, and contains initial questions that subsequently provide the patient with individually-tailored health information. In addition, the app provides relevant information to the clinician on patients' SRH to optimize the time together as part of the visit. In total, the app takes approximately 10-15 minutes to complete. The purpose of this study is to evaluate the efficacy of the Health-E You app among male youth ages 12-21 using a cluster-randomized stepped-wedge design. A participant will be considered to have completed the study if the participant has completed the baseline assessment, worked through the app, an immediate follow-up assessment, and a 2-month post-visit follow-up assessment. The end of the study is defined as completion of the 2-month follow-up assessment. Hypotheses include compared to usual care, app users will have greater improvements in male method use behaviors (i.e., condom use) as well as knowledge about pregnancy and sexually transmitted infection (ST)I prevention methods, male method use self-efficacy, beliefs about male/female methods, improved knowledge about SRH care, self-efficacy talking with a clinician about SRH, beliefs about SRH promotion, and SRH care receipt.

Eligibility Criteria:
Inclusion Criteria:

* Assigned male sex at birth
* Age 12 to 21 years old
* English and/or Spanish as preferred language to read, listen, and converse
* Self-reported engagement in vaginal and/or anal sex in the past 12 months
* Access to phone or internet for follow-up study activities

Exclusion Criteria:

* Aged 11 or younger or older than 21
* Primary language other than English or Spanish
* Not able to provide informed consent
* Unable to communicate due to cognitive, mental, language, or other difficulties
* Not sexually active, engaged in oral sex only, or more than 12 months have passed since last vaginal and/or anal sex.
* Previous participation in a Health-E You study activity or the app
Drug Patch Tests in Patients With Severe Cutaneous Adverse Reaction to Drugs (SCARs)

The study is about drug patch tests in patients who have history of severe cutaneous drug reaction including Steven Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), Drug-induced eosinophilia and systemic symptoms (DRESS), AGEP (Acute generalized exanthematous pustulosis) and generalized bullous fixed drug eruptions. This study also investigate in Enzyme-linked immunosorbent spot assay (ELIspot) and lymphocyte transformation test. We also trying to prove the correlation among result of drug patch tests, ELIspot and LTT.


Eligibility Criteria:
Inclusion Criteria:

* Patients with history of Steven Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug-induced eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), generalized bullous fixed drug eruption in the past 24 months.
* Age more than 18 years old

Exclusion Criteria:

* Receiving immunosuppressive drugs or more than 10 mg/day of prednisolone within 1 month.
* Pregnancy and lactation
A Bioequivalence Study of Two Different PEG-rhGH Preparations

The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.

The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male aged ≥18 years old and≤45 years old;
* The Body mass index (BMI): 19-26 kg/m2 (inclusive), and body weight ≥50 kg;
* Normal results of physical examination, vital signs, laboratory tests, 12 lead-ECG, chest X-ray, abdominal ultrasound, or non-clinical significance changes in the assessments above.

Exclusion Criteria:

* Subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs containing; or a history of allergic diseases (including but not limited to asthma, urticaria, etc.), or allergic constitution (such as known allergy to two or more substances)
* Subjects with a clear history of disorders of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic system, etc., or suggest potential diseases, such as abnormal laboratory test results of liver and kidney function (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] exceeding the upper limit of normal, or total bilirubin exceeding the upper limit of normal; Or blood creatinine exceeding the upper limit of normal value); Or other diseases (such as a history of mental illness) deemed unsuitable for participation in the trials by the investigators;
* Subjects with severe infection, severe trauma, or major surgery within 6 months prior to screening;
* Subjects who have received blood transfusions, had blood donors, or lost blood ≥400 mL within 3 months before screening; Or plan to donate blood within 1 month of the end of the trial;
* Subjects who have positive results of human immunodeficiency virus antibodies (HIV-Ab), or hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies (HCV-Ab), or syphilis specific antibodies (TPPA);
* Subjects who have participated in clinical trials for medication or medical device within 3 months prior to screening;etc.
Early Identification of Suspected Deep Tissue Injury (sDTI)

The purpose of this study is to further clarify existing research on the early identification and documentation of suspected deep tissue injury (sDTI). Basic principles of physiology along with prior research suggests that sDTI has quantifiable amounts of heat (or lack thereof) relative to surrounding tissue that will exhibit characteristic thermal signatures (temperature). These signatures will be measured and quantitatively recorded using long-wave infrared thermography (LWIT) to not only identify sDTI, but to also learn more about their pathophysiological evolution. Additionally, the LWIT physiological data will be cross-compared to the gold standard of visual assessment and other current standards of wound evaluation.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Can tolerate position changes ≥ 10 minutes
* Non-pregnant

Exclusion Criteria:

* Therapies/treatments cannot be safely suspended to for an imaging session
* Non-English speaking
Generation of Anti-HCV Antibodies From Bone Marrow: Defining the Repertoire of Immune Response to HCV Quasispecies

To generate a library of genes that reflect the entirety of antibody responses to hepatitis C virus (HCV) made during the 20-year course of HCV infection in a single patient (WH) whose viral quasispecies has been extensively characterized. In addition to characterizing the sequential events in antibody formation and their relationship to the changing pattern of viral quasispecies, we hope to identify neutralizing antibodies and the epitopes to which they are directed. Ultimately we seek to gain insight into the host mechanisms that suppress viral replication and to translate this to therapeutic and preventive modalities.

To generate a library of genes that reflect the entirety of antibody responses to hepatitis C virus (HCV) made during the 20-year course of HCV infection in a single patient (WH) whose viral quasispecies has been extensively characterized. In addition to characterizing the sequential events in antibody formation and their relationship to the changing pattern of viral quasispecies, we hope to identify neutralizing antibodies and the epitopes to which they are directed. Ultimately we seek to gain insight into the host mechanisms that suppress viral replication and to translate this to therapeutic and preventive modalities.

Eligibility Criteria:
Persistent infection with mild hepatitis that is non-progressive.
Clinical Pharmacological Study of GnRH Antagonist, Cetrorelix for Healthy Female Volunteer

GnRH analogs are globally used for assisted reproduction in infertile patients. To date, in healthy female volunteers the pharmacokinetic and pharmacodynamic profiles of cetrorelix when administered in a single dose have been investigated in studies conducted using doses of 1, 3 and 5 mg. Studies performed in premenopausal female volunteers confirmed that cetrorelix rapidly suppresses luteinizing hormone (LH) and estradiol and shows dose-dependent prolongation of the duration of LH suppression. However, there have been few reports of studies of the relationship between the cetrorelix dosage and its effect on LH surge. In the present study, we investigated the effect of cetrorelix on LH surge when this drug was administered in single doses of 1, 2 and 3 mg.

To evaluate that effect on LH surge, we investigated the efficacy of cetrorelix in delaying the start of the LH surge in comparison with the control menstrual cycle when saline was administered, and also examined the mode of disappearance of pulsatile LH secretion during the cetrorelix administration menstrual cycle.

Eligibility Criteria:
Inclusion Criteria:

* a BMI of 18 years old and \<18 and 25 years old and \>25
* menstrual cycles was within the range of 25\~31 days

Exclusion Criteria:

* use of a drug (e.g., oral contraceptives, drugs for treatment of hyperprolactinemia, GnRH agonists, sex steroid hormones, psychoactive drugs, etc.)
* serious disease of the endocrine system, liver, kidney, heart, lung, digestive system, etc.
* a generalized drug allergy
Sources of Bacterial Contamination in Human Milk Samples From the MiLC Trial

This observational study is a sub-study of the MiLC Trial (ClinicalTrials.gov Identifier: NCT03123874). Our objective is to characterize the bacterial communities of women's breasts, hands, their pump and milk collection kit, and their babies' mouths among the participants of the MiLC Trial. As part of the original protocol, we collected swabs of each of these areas from each dyad before women pumped with their own pumps. By characterizing these communities, we can identify from where the bacteria in human milk (HM) originates, and determine whether pumping with mother's own pumps enriches the bacterial communities of HM compared to pumping with a sterile pump.


Eligibility Criteria:
Inclusion Criteria:

* Mother-infant dyads who participated in the MiLC Trial.

Exclusion Criteria:

* Anyone who did not participate in the MiLC Trial.
GR1803 Injection in Patients With RRMM

All subjects will receive GR1803 injection until intolerable toxicity or investigator-assessed disease progression occurs (except in cases of disease progression due to discontinuation of the drug as a result of an adverse event) or until the subject has been administered the drug for 2 years or until the subject withdraws consent or until the investigator determines that the subject needs to be discontinued.


Eligibility Criteria:
Inclusion Criteria:

* 1、ECOG score 0-2 2、≥18 years of age 3、Multiple myeloma must be Complicated by Extramedullary Plasmacytoma.

Exclusion Criteria:

* 1、Prior treatment with any BCMA-targeted therapy 2、Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma 3、Known allergies, hypersensitivity, or intolerance to the study drug (teclistamab) or its excipients 4、Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.
Single and Multiple Ascending Dose Study of JW1601 for Healthy Volunteers

This study is conducted to evaluate the safety/tolerability and PK/PD of JW1601 after oral administration in healthy Korean, Caucasian and Japanese adult volunteers

This is a dose block-randomized, double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and PK/PD profile by administering investigational product (IP) as a single dose (One time) or repeated doses (7 days, once a day) orally in a fasted state.

Eligibility Criteria:
Inclusion Criteria:

- Subjects who have voluntarily given written informed consent to participate in the study and comply with all study requirements after getting detailed explanation and full understanding of the study

Exclusion Criteria:

- Subjects judged by the investigators unsuitable for participating in the study based on any other reasons
Investigate the Efficacy and Safety of Farudodstat Compared With Its Placebo in Adult Alopecia Areata Participants

The main purpose of this study is to measure the efficacy of farudodstat compared to placebo at Week 12 from the treatment start, in adult participants with Alopecia Areata (AA) with 30% or greater scalp hair loss.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years of age and a weight of ≥40 kg at the time of signing the informed consent)
* Moderate, severe, or very severe Alopecia Areata (AA), as determined by meeting the following criteria:

  1. Clinical diagnosis of AA with no other etiology of hair loss (e.g., telogen effluvium, androgenetic alopecia, etc.)
  2. At least 30% scalp hair loss, as defined by a SALT score ≥30
  3. Current episode of hair loss lasting at least 6 months and not exceeding 7 years at the time of Screening. Participants who have AA for longer than 7 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 7 years
  4. No appreciable change (i.e., change exceeding 20 points on SALT score) in terminal hair regrowth within 6 months

Exclusion Criteria:

* Known history of androgenic alopecia or female pattern hair loss prior to AA
* Other types of alopecia (including, but not limited to traction and scarring alopecia, telogen effluvium, diffuse type of AA)
* History or presence of hair transplants
* Other scalp disease that may impact AA assessment or require topical treatment (including, but not limited to scalp psoriasis, seborrheic dermatitis, actinic keratosis)