cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Liver Transplantation for Hepatocellular Carcinoma With Bile Duct Tumor Thrombus: a Single-arm, Multicenter, Prospective Study (HCC-BDTT in LT)

The prognosis for patients diagnosed with hepatocellular carcinoma with bile duct tumor thrombus (BDTT-HCC) remains notably grim, as there are presently no universally accepted treatment guidelines in place to address this complex condition. Long-term outcomes of liver transplantation (LT) for BDTT-HCC are unclear, whether LT is a proper therapeutic option for BDTT-HCC patients remains to be determined. Therefore, we designed a clinical trial to evaluate survival of BDTT-HCC patients in LT. This is an open-labeled, single-arm, prospective, multicenter and real-world study designed to assess the survival outcomes of BDTT-HCC patients in LT. Patients will be enrolled based on histological confirmation of HCC with BDTT. The study will span a total of 4 years, including a 2-year enrollment phase and a subsequent 2-year follow-up period. We anticipate that LT will provide favorable survival benefits for BDTT-HCC patients, particularly in the key indicator recurrence-free survival (RFS) and improved quality of life. Upon successful completion of the trial, we will extend our monitoring over a longer follow-up time to accurately estimate important indicators such as overall survival (OS). We expect that this study will provide substantial evidence to refine treatment guidelines through thorough data analysis, ultimately contributing to better patient outcomes and advancing our understanding of the disease.


Eligibility Criteria:
Inclusion Criteria:

(1) age between 18 and 70 years; (2) Postoperative pathological diagnosis of HCC with BDTT requiring LT; (3) the general condition can tolerate the operation; (4) written informed consent given by the patient; (5) patients without distant metastasis.

Exclusion Criteria:

(1) Those who did not undergo regular LT for various reasons, split LT, reduced-size LT, simultaneous transplantation, re-transplantation, multiple-organ recipients are excluded; (2) Additional surgical procedures such as pancreaticoduodenectomy were performed; (3) those with other diseases such as active pulmonary tuberculosis, coronary heart disease, renal insufficiency and so on, which affect the therapeutic effect; (4) Extensive abdominal metastasis was found during operation; (5) serious consequences or deaths caused by anesthesia accident during operation; (6) Postoperative death due to other diseases such as traffic accidents, cardiovascular and cerebrovascular accidents; (7) With distant metastasis before operation.
Safety and Efficacy of DNK333 in Atopic Dermatitis Patients

This study will assess the safety and efficacy of DNK333 in patients with atopic dermatitis suffering from pruritus, who require systemic treatment of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Male and female atopic dermatitis patients,18 to 60 years of age inclusive, who fulfill the following criteria:
* Requirement of systemic therapy
* Itch VAS score higher than 50 mm
* EASI score higher than 8

Exclusion Criteria:

* Women of child-bearing potential who are not willing to use two highly effective methods of contraception are not allowed in the study. Similarly, men who are not willing to use two acceptable methods of contraception are not allowed in the study.
* Any systemic immunosuppressive treatment and/or phototherapy within 4 weeks prior to the first dosing.
* Use of any systemic antihistamines or topical corticosteroids within one week prior to first dosing and for the duration of the treatment period. Any other topical or oral treatment for atopic dermatitis (except emollients prescribed by the investigator) within 2 weeks prior to the first dosing will also be excluded.

Other protocol-defined inclusion/exclusion criteria may apply
DDX3X Syndrome -The Seaver Autism Center for Research and Treatment is Characterizing DDX3X-related Neurodevelopmental Disorders Using Genetic, Medical, and Neuropsychological Measures.

DDX3X syndrome is a genetic cause of intellectual disability and other neurologic features including, in some cases, autism. Variants in the DDX3X gene are thought to account for 1-3% of unexplained intellectual disability in females, making it one of the more common causes of intellectual disability.This study seeks to characterize DDX3X-related neurodevelopmental disorders using a number of genetic, medical and neuropsychological measures.

Subjects with a variant in the DDX3X gene will be asked to complete a battery of developmental, behavioral and medical assessments to better characterize gene-related neurodevelopmental deficits. This series of assessments takes place over the course of a three-day period. It includes the Autism Diagnostic Observation Schedule (ADOS), parent interviews regarding developmental history and behavior, a psychiatric evaluation, a neurology assessment, as well as a clinical genetic evaluation that includes a physical and vitals exam. Affected individuals, as well as biologically related siblings, will also undergo a series of sensory assessments, including a research EEG, visual evoked potential, and an eyetracking assessment. Family members present for the visit will also be asked to provide a blood and/or saliva sample for research genetics.

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants must have a documented variant affecting the DDX3X gene that the research team determines to be likely or definitely pathogenic.
* Eligible participants must be at least 2 years of age.

Exclusion Criteria:

* None
A Trial Investigating the Mechanism of Action of NNC0109-0012 (Anti-IL-20 mAb) Through Synovial Biopsies in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

This trial is conducted in Europe. The aim of the trial is to investigate the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis (RA) and an inadequate response to Methotrexate.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age at least 18 and below or equal to 75 years at the time of signing informed consent
* A diagnosis of RA at least 6 months prior to screening visit, according to the American College of Rheumatology (EULAR/ACR 2010 criteria) or by standard criteria (ACR 1987) if diagnosis was made earlier than 2010
* Subjects with ACR global functional status of 1 to 3
* Active RA, characterised by: DAS28 (Disease Activity Score 28) (CRP (C-reactive protein)) above 4.5 and equal to or above 6 tender and equal to or above 6 swollen joints based on a 66/68 joint count
* Active Synovitis in at least two joints of the wrist and metacarpophalangeal joints, as assessed by high frequency Power Doppler ultrasound scan at screening and randomisation

Exclusion Criteria:

* Subjects with arthritis due to other autoimmune diseases than RA
* Body weight above 90.0 kg
* History of or current inflammatory joint disease other than RA (e.g. gout, psoriatic or reactive arthritis, Lyme disease, juvenile idiopathic arthritis, excluding secondary Sjogren syndrome and hypothyroidism)
* Any active or on-going bacterial infections within 4 weeks prior to screening visit, unless treated and resolved with appropriate therapy or any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis)
* Subjects with malignancy within the previous 5 years with the exception of adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ occurring more than 12 months prior to screening visit
* Female who is pregnant, breast feeding, intends to become pregnant or is of childbearing potential, not willing to use two highly effective contraceptive methods (adequate highlyeffective contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system) one of which has to be a barrier method a barrier method of contraception (e.g. condom with spermicidal foam/gel/film/cream), for at least 16 weeks (approximately 5 half-lives) following the last dose of trial medication
* Male subjects who are sexually active and not surgically sterilised, who or whose partner are unwilling to use two different forms of highly effective contraception, one of which has to be a barrier method a barrier method of contraception (e.g. condom with spermicidal foam/gel/film/cream) for the duration of the trial and for at least 16 weeks (approximately 5 half-lives) following the last dose of trial medication
Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure

Study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of GGF2 in patients with heart failure.

Phase 1, double-blind, placebo-controlled, dose escalation study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of GGF2 in cohorts of patients with left ventricular dysfunction and symptomatic heart failure.

Eligibility Criteria:
Inclusion Criteria:

1. Left ventricular ejection fraction (LVEF) between 10% and 40%.
2. Male or female, aged 18 to 75 years, inclusive.

Exclusion Criteria:

1. Received any investigational agent or participation in any clinical study of an investigational agent or investigational therapy up to 30 days prior to the screening visit.
2. Use of any new prescription medication up to 14 days prior to receiving investigational drug.
3. Patients with known specific hepatic disease; bilirubin \>2 mg/dL, SGOT \> 100 IU.
4. Patients with a history of hepatic impairment (hepatitis B and C).
5. Serum creatinine \>2.5 mg/dL.
6. Documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment.
Johns Hopkins Crohn's Disease and Ulcerative Colitis Study

Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), is a idiopathic, chronic and frequently disabling inflammatory disorder of the intestines characterized by a dysregulated mucosal immune response that affect more than a million Americans. This current protocol was established in 1996 with the goal of identifying the genetic and environmental components that contribute to the development of IBD, especially in families.

We initiated this research study in 1996 with the overall goal of identifying IBD susceptibility genes. In the beginning, our major focus was recruitment of multiply affected IBD pedigrees for linkage studies, but we have since expanded our study to include singleton cases and spousal/friend as well as population controls for comparison purposes Our recruitment goal is 2500 subjects.

Blood samples obtained from participants are used to isolate lymphocytes for storage, serum for serological analysis of antibodies and other proteins relevant to IBD and DNA for genotyping or sequencing. Lymphocytes may be transformed with EBV to establish immortalized lymphoblastoid cell lines. These cell lines can be used as a secondary DNA source or to study IBD relevant gene, protein expression and cell function

Eligibility Criteria:
Inclusion Criteria:

ADULTS:

* Patients with IBD and their family members who have or do not have IBD.
* People that do not have IBD nor have a family member with IBD needed for comparison purposes.

CHILDREN:

* Children age 5 or older with IBD and their family members who have or do not have IBD.
* Children that do not have IBD nor have a family member with IBD needed for comparison purposes.

Exclusion Criteria:

* The only exclusions are age parameters and health reasons that would preclude their enrollment; such as, for anemic patients. Blood-draws on anemic patients may, in certain medical cases, pose a health risk to them; therefore, we request that if they are anemic that they present a letter from their personal physician giving explicit permission for them to join if at the time it is clinically advisable.
Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Diffuse Cutaneous Systemic Sclerosis

The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of EHP-101 in adult subjects with diffuse cutaneous Systemic Sclerosis (dcSSc).

An interventional, double-blind, randomized, intracohort placebo-controlled design will be used to test safety, tolerability, pharmacokinetics, and preliminary efficacy of EHP-101 in 36 patients ≥ 18 and ≤ 74 years of age with documented dcSSc. There is a screening period of 28 days, 84 days treatment period, and 28 days follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients male and female ≥18 years and ≤74 years at the time of consent;
* American College of Rheumatology/ European League Against Rheumatism 2013 Criteria for SSc; dcSSc (skin thickening on upper arms, upper legs, or trunk);
* Documented SSc for up to 6 years from the first non-Raynaud's phenomenon with a total mRSS of ≥15;
* No new or increased doses of immunosuppressants medications within 3 months prior to Screening;
* Effective method of contraception for participants and their partners.

Exclusion Criteria:

* Severe or unstable Systemic Sclerosis (SSc) or SSc with end-stage organ failure;
* Patient with FVC \<60%;
* History of clinically significant medical condition or concurrent medical therapies that would exclude the patient, preclude participation in the clinical trial, influence response to study product, or interfere with study assessments;
* History of gastrointestinal dysmotility requiring total parenteral nutrition or hospitalization within 6 months before Visit 1;
* Any one of the following values for laboratory tests at screening:

  * Haemoglobin \<9 g/dL;
  * Neutrophils \<1.0 x 10\^9/L;
  * Platelets \<75 x 10\^9/L;
  * Estimated creatinine clearance \<50 mL/min according to the Cockcroft-Gault equation;
  * Serum transaminases \>2.0 x upper normal limit;
  * Total bilirubin ≥1.5 x upper limit of normal.
Mobile Phone Thermal Imaging Assessment of Incompetent Perforator Veins

Chronic venous disease is a common disease of the lower limbs. Severe CVD can lead to lower limb swelling, pigmentation, and repeated skin ulceration, which seriously affects patients' quality of life. About 10.5% to 92.7% of CVD patients with recurrent varicose veins had insufficient perforating veins. Treatment of these IPVs can promote venous ulcer healing and reduce the recurrence rate of venous ulcers. Accurate assessment and positioning of insufficient perforating veins in the lower leg is a key step in developing a personalized treatment strategy. At present, Color Doppler ultrasonography performed in the upright position in combination with the Valsalva maneuver or local pressure of the limb is regarded as the "gold standard" for the diagnosis of perforating veins insufficiency. However, in China, a large number of perforating veins insufficiency are diagnosed by venography. Because the majority of Chinese vascular surgeons are not versatile in vascular ultrasound examination and venous ultrasound protocols vary from institution to institution. A non-functioning valve in an insufficient perforated vein allows blood to flow retrograde from a deep vein to a superficial vein. Some researchers have shown that the venous blood temperature of deep veins is higher than that of superficial veins. Thus, the retrograde flow of "warm blood" from the deep vein to the superficial vein increases the skin temperature located on the insufficient perforated vein. This study tested the feasibility of a smartphone and its compatible portable thermal imaging device as a tool for assessing insufficient perforated vein. The objective is to study the sensitivity and specificity of smartphone thermal imaging in diagnosing and locating the insufficient perforated vein in CVD patients.


Eligibility Criteria:
Inclusion Criteria:

A diagnosis of CVD by vascular surgeon, classified C0 to C6 according to CEAP (Clinical-Etiology - Anatomy - Pathophysiology) No history of lower extremity surgery The body mass index (BMI) is 18 to 35 kg/m2

Exclusion Criteria:

deep vein thrombosis heart disease peripheral artery disease chronic liver disease chronic kidney disease pregnancy severe obesity (BMI ≥35 kg/m2)
The Sarcoma Biology and Outcome Project

SarcBOP - An interdisciplinary and translational registry

SarcBOP aims to establish a database that integrates every aspect possibly relevant to sarcoma treatment and research. SarcBOP thus will not be limited to specific questions or patient groups, but instead will build a comprehensive database including clinical, pathologic, and radiologic information, multi-layered molecular data, and patient-reported outcomes, combined with a dedicated biobank for tissue samples and liquid biopsies. As the study integrates seamlessly with the clinical activities of the Heidelberg Sarcoma Center, the Molecular Diagnostics Program of NCT Heidelberg, including the NCT/DKTK MASTER Program, and with the NCT Trial Center, including the PMO Clinical Trials Program, SarcBOP will generate a comprehensive and continuously growing resource for clinicians, researchers, and, finally, patients.

The following data are collected and stored:

* Demographics
* Comorbidities
* Clinical characteristics at diagnosis, relapse and progression
* Radiologic images
* Histological images
* Treatments including DRG and OPS data, including detailed information on surgical, radiation, and medical therapy as well as treatment relevant follow-up data
* Longitudinal disease assessments
* Clinical outcome
* Genomic, transcriptomic, epigenomic and proteomic data
* Patient reported outcomes

Furthermore, biological samples are collected and processed by the Sample Processing Laboratory of the Heidelberg Center for Personalized Oncology and the NCT Biobank.

Eligibility Criteria:
Inclusion Criteria:

* Suspected or proven diagnosis of soft-tissue or bone sarcoma (STBS)
* Age ≥12 years
* Ability to understand nature and individual consequences of the registry
* Written informed consent
* Subjects who are physically or mentally capable of giving consent

Exclusion Criteria:

• Severe neurological or psychiatric disorder interfering with the ability to give written informed consent
Stress Urinary Incontinence of Sporting Teenager

Physical activity and sport are beneficial to the cardiovascular system, the musculoskeletal system and many chronic pathologies. The High Authority of Health (HAS) recommends a regular practice. However, depending on the discipline and level of practice, it may be responsible for traumatic injuries, degenerative musculoskeletal injuries, overtraining, eating disorders or cardiovascular events. It also promotes urinary stress incontinence, by increasing intra-abdominal pressure in some situations.

The prevalence of urinary leakage in the athlete depends of the practiced physical activity. A classification of the sports activities can be carried out according to the risk of increased pressures on the pelvic floor:

* high-risk sports: trampoline (10.17), acrobatic gymnastics, aerobics, athletics (jumping hedges, heights, triple jump), horse riding, basketball, volleyball, handball, martial arts;
* moderate-risk sports: tennis, skiing ...
* low risk sports: walking, swimming, cycling, rollerblading, golf ... In sports, urinary incontinence also depends of the practiced movements (jumps, abdominal exercises ...), and the occurence of sports activity. This disorder has even become one of the concerns of federal sports authority (INSEP).

However, there is no data regarding stress incontinence of sports teenagers found n the literature on


Eligibility Criteria:
Inclusion Criteria:

* Between 10 and 18 years
* Consultation in medical sporting center

Exclusion Criteria:

* urge incontinence
Does Use of Topical Lidocaine in EGD Reduce Amount of IV Midazolam and Fentanyl Required and Shorten Recovery Time

Patients will be randomized to a placebo or study group who will receive topical lidocaine prior to EGD. Amount of medication used, recovery time, patient/endoscopist satisfaction will then be assessed.

The study will be a double blinded randomized placebo controlled trial

Patients between 18 and 89 years old who are scheduled for EGD may be eligible to enroll in the study. Potential subjects will be sought through referral by their treating attending and fellow gastroenterologist, who will be apprised of the inclusion and exclusion criteria. Patients possibly meeting inclusive and exclusive criteria will be approached and discussed the study further with the investigators. Those expressing a desire to participate in the study will be given written informed consent prior to participation. The investigators will enroll patients into the study with a goal of at least 53 patients in each group which is the number of patients our statistician recommended to appropriately power our study.

Patients who consent to enroll in the study will be randomized into 2 groups. Group 1: Swish and swallow 10ml of 2% lidocaine solution Group 2: Swish and swallow 10ml of 0.45% sodium chloride solution

The patients will then undergo endoscopy for the indication identified in their clinic appointment. Following the procedure, patients will be taken to the recovery area and recovered per clinic protocol. The endoscopist will complete a satisfaction questionnaire. The day following the procedure a nurse will call to check for post-operative complications per clinic protocol. The day following, an investigator will also call to perform a patient satisfaction survey..

Eligibility Criteria:
Inclusion Criteria:

* EGD alone performed by staff gastroenterologist as an outpatient
* Between the age of 18 and 89
* Not requiring anesthesia support or use of medications other than fentanyl and midazolam

Exclusion Criteria:

* Prior history of head and neck surgery
* Known hypersensitivity to local anesthetics, the amide type or any components of the topical lidocaine
* Patients having interventions other than polypectomy performed
* Pregnant or breast feeding females
* Patients with severe liver impairment
* Known hypersensitivity to benzodiazepine or fentanyl