cyrilzakka/clinical-trials huggingface dataset:
DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]

The primary purpose of this trial is to compare the efficacy and safety of DS-8201a and physician's choice treatment in HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens including fluoropyrimidine agent, platinum agent, and trastuzumab.


Eligibility Criteria:
Inclusion Criteria:

1. Has a pathologically documented locally advanced or metastatic adenocarcinoma of gastric or gastroesophageal junction
2. Progression on and after at least 2 prior regimens
3. Has an adequate tumor sample
4. Has measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1

Exclusion Criteria:

1. Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia
2. Has a QTc prolongation to \> 450 millisecond (ms) in males and \> 470 ms in females
3. Has a medical history of clinically significant lung disease
4. Is suspected to have certain other protocol-defined diseases based on imaging at screening period
5. Has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:

   1. safety or well-being of the participant or offspring
   2. safety of study staff
   3. analysis of results
Effectiveness Of Intravenous Vs Rectal Acetaminophen For Pain Management In Post Operative Neonates

This randomized controlled trial aims to evaluate the effectiveness of intravenous (IV) versus rectal acetaminophen for postoperative pain management in neonates. The study includes postoperative term neonates who require analgesia for at least 12 hours. The main questions the study seeks to answer are:

Does IV acetaminophen provide better pain relief compared to rectal administration in neonates? What is the time to rescue analgesia and the efficacy of pain score reduction between these two routes? The study compares 32 neonates receiving IV acetaminophen to 32 neonates administered rectal acetaminophen. Both routes are administered at equivalent bioavailable doses to ensure a fair comparison.

This randomized controlled trial investigates the comparative effectiveness of intravenous (IV) versus rectal administration of acetaminophen for managing postoperative pain in neonates. Neonates, due to their limited physiological reserves and underdeveloped metabolic systems, require precise pain management strategies to prevent potential developmental delays or adverse effects. Acetaminophen, a commonly used analgesic in neonatal care, is metabolized primarily by the liver and excreted via the kidneys. However, its pharmacokinetics vary significantly based on the route of administration, making it important to evaluate which method offers more reliable pain relief.

The study includes 64 term neonates who underwent surgery and are expected to require pain relief for at least 12 hours. Preterm and preoperative neonates are excluded. The neonates were randomized into two groups: one receiving acetaminophen intravenously (15 mg/kg) and the other rectally (40 mg/kg), ensuring similar concentrations at the effect site.

Key variables include rescue analgesia requirements, time to rescue analgesia, and changes in pain scores. Pain relief efficacy is measured by pain score changes, and any need for additional analgesia is recorded.

This study will provide valuable insights into the optimal route for administering acetaminophen in neonates.

Eligibility Criteria:
Inclusion Criteria:

* All post-operative neonates requiring acetaminiphen as analgesia.

Exclusion Criteria:

* All neonates requiring any other kind of Pain relief medication (Nerve block or local analgesia)
* All neonates in neonatal ICU
* All neonates with central venous line in place
* All neonates that are on ventilatory support
Safety and Effectiveness of Giving SU5416 to HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma

The purpose of this study is to see if it is safe and effective to give SU5416 to HIV-infected patients with AIDS-related Kaposi's sarcoma (KS). SU5416 may prevent the growth of KS tumors.

Groups of 3-6 patients are sequentially assigned to receive escalating doses of SU5416 in 33% increments. Study drug is administered as a twice-weekly intravenous injection for 4 weeks. In the absence of unacceptable toxicity, responding patients may continue on SU5416 in 4-week treatment cycles for a maximum of 1 year or until the presence of unacceptable toxicity or tumor progression.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are at least 18 years old.
* Are HIV-positive.
* Have KS with at least 5 skin lesions.
* Have been in stable condition for at least 6 weeks prior to study entry, if receiving antiretroviral therapy.
* Agree to use effective methods of birth control during the study.

Exclusion Criteria

You will not be eligible for this study if you:

* Have had surgery within 4 weeks of study entry.
* Have taken certain medications, including therapy for KS, within 3 weeks prior to study entry.
* Have pulmonary KS (KS in your lungs).
* Have certain serious medical conditions, including liver or kidney problems, certain infections, and certain cancers.
* Are allergic to Cremophor.
* Have not recovered from previous cancer treatment (chemotherapy, radiotherapy, or immunotherapy).
* Are pregnant.
Alemtuzumab in Treating Patients With Relapsed or Refractory Advanced Mycosis Fungoides or Sézary Syndrome

RATIONALE: Monoclonal antibodies such as alemtuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with relapsed or refractory advanced mycosis fungoides or Sézary syndrome.

OBJECTIVES:

* Determine the response rate of patients with relapsed or recurrent advanced mycosis fungoides or Sézary syndrome treated with alemtuzumab.
* Determine the toxicity of this drug in these patients.

OUTLINE: Patients receive alemtuzumab IV over 2 hours three times per week. Treatment continues for up to 12 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed mycosis fungoides or Sézary syndrome

  * Stage IB-IVB
* Measurable disease

  * One or more indicator lesions
  * No prior radiotherapy to areas of measurable disease unless there is clear disease progression at the site or measurable disease outside the area of prior radiotherapy
  * Generalized erythrodermia patients with evaluable disease only are allowed
* Must have failed at least 1 prior systemic therapy

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-2 OR
* WHO 0-2

Life expectancy

* At least 3 months

Hematopoietic

* WBC at least 3,000/mm\^3
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic

* Bilirubin no greater than 2.2 mg/dL
* AST or ALT no greater than 2 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2 times ULN

Renal

* Creatinine no greater than 2.0 mg/dL

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No acute infection requiring intravenous antibiotics
* No other prior neoplasm except treated squamous cell or basal cell skin cancer, treated carcinoma in situ of the cervix, or other cancer that received surgical treatment only from which patient has been disease free for at least 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

* More than 4 weeks since prior biologic therapy

Chemotherapy

* More than 4 weeks since prior chemotherapy

Endocrine therapy

* More than 4 weeks since prior topical steroids

Radiotherapy

* See Disease Characteristics
* At least 2 weeks since prior radiotherapy (local control or palliative)
* No concurrent radiotherapy to any lesion

Surgery

* Recovered from prior major surgery

Other

* Recovered from prior therapy
* No other concurrent proven or investigational antineoplastic agents
A SBT-based Protocol-directed Program in Difficult-to-Wean Patients

Weaning patients from a ventilator is one of the most challenging processes in an intensive care unit. The investigators aimed to determine whether spontaneous breathing trial (SBT)-based protocol-directed weaning combined with the high-flow nasal cannula (HFNC) could be superior to routine SBT-based weaning in reducing the duration of mechanical ventilation (MV) in difficult-to-wean patients.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 16 years old
* MV for more than 48 hours
* intubated or tracheostomized

Exclusion Criteria:

* pregnancy
* irreversible respiratory failure caused by neurodegenerative disorders, such as Alzheimer disease, motor neuron disease, or multiple system atrophy
* pre-existing decision to limit life support
* waiving of MV during treatment
* terminal stage of severe illness
A Study to Assess the Safety of Xospata in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-Like Tyrosine Kinase 3 (FLT3) Mutation

The objective of this study is to describe the observed safety profile of Xospata® 40 mg tablet when administered in patients with relapsed or refractory AML with FLT3 mutation in routine clinical practice in Korea.

This study is being mandated by Ministry of Food and Drug Safety (MFDS) as a part of the Korea-Risk Management Plan (K-RMP) to assess safety in patients with relapsed or refractory AML with FLT3 mutation in routine clinical practice in Korea. This study collects data for 54 months according to the purpose of this study in routine clinical practice as an observational study.

Eligibility Criteria:
Inclusion Criteria:

* Patients who receive Xospata® 40 mg tablet according to the drug label approved at the time of marketing authorization in routine clinical practice.
* Patients who voluntarily signed the written informed consent form.

Exclusion Criteria:

* Patients who meet the section 'Do not administer to the following patients' in the precautions for use given at the time of marketing authorization.
* Patients who use the drug for an off-label purpose.
Induction Chemotherapy Prior to Radio-immunotherapy in Head and Neck Cancer Stage III/IV - a Methodical Trial

The purpose of the trial is to determine the feasibility of an induction chemotherapy with radio-immunotherapy in patients with head and neck cancer stage III/IV

3 Cycles of: Docetaxel 75 mg/m2 on d1, Cisplatin 75 mg/m2 on d1, 5-FU 750 mg/m2 on days 1-5 as continuous i.v. infusion, Duration of 1 cycle: 21 days;

Followed by Cetuximab 400 mg/m2, Start of radiotherapy: 1 week after the first application of Cetuximab, During radiotherapy (35 x 2 Gy): Cetuximab 250 mg/m2 weekly, Up to 8 applications of Cetuximab.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed, locally advanced head and neck cancer
* stage III/IV
* performance status: ECOG 0-1

Exclusion Criteria:

* distant metastases
* prior radiotherapy of the head and neck region
* myocardial infarct in the last six months
* florid peptic ulcer
* neuropathy grade III/IV
Safety of ALK Ragweed Tablet

This trial is performed to assess whether ALK Ragweed Tablet is safe to use in adults


Eligibility Criteria:
Inclusion Criteria:

* Ragweed pollen induced rhinoconjunctivitis
* Adults of either sex (18-50 years of age)
* Positive skin prick test to ragweed

Exclusion Criteria:

* Previous treatment with immunotherapy
Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III)

The aim of this clinical trial is to investigate the safety and efficacy of allo-APZ2-OTS administered intravenously to subjects with recessive dystrophic epidermolysis bullosa (RDEB) compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects from 6 months of age with a diagnosis of RDEB confirmed by genetic testing or by a skin biopsy with immunofluorescence mapping
2. Subject is eligible to participate in this clinical trial based on general health condition;
3. Subject with a target wound meeting the following criteria: 5-50 cm2, ≥ 21 days and \< 9 months, no signs of acute infection;
4. Patient/legal representative understands the nature of the procedure and provide written informed consent/assent prior to any clinical trial procedure;
5. Women of childbearing potential must have a negative urine pregnancy test at Visit 1. Women of childbearing potential, male participants, and their partner must be willing to use highly effective contraceptive methods during the course of the entire clinical trial.

Exclusion Criteria:

1. Any current tumor diseases, including squamous cell carcinoma and basal cell carcinoma;
2. Any known allergies to components of the IP or premedication;
3. Patient/legal representative anticipated to be unwilling or unable to comply with the requirements of the protocol;
4. Pregnant or lactating women;
5. Current or previous (within 30 days of screening) treatment with another IP, or participation and/or under follow-up in another interventional clinical trial;
6. Previous participation in this clinical trial (except for screening failures);
7. Clinically significant or unstable concurrent disease or other clinical contraindications like an uncontrolled or poorly controlled mental health condition of the subject and/or his/her legal representative that could impact on patient's safety or interfere with study compliance such as inability to attend scheduled study visits; Confidential
8. Employees of the sponsor, or employees or relatives of the investigator.
Switching HIV-1 Infected Subjects From a Highly Active Anti-Retroviral Treatment (HAART) Regimen Dosed Twice Daily or More Frequently to a Once-Daily Regimen

The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a standard-of-care regimen dosed twice-daily or more frequently to a simpler once-daily (QD) regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels \<50 copies/mL after switching to a QD regimen.


Eligibility Criteria:
Inclusion Criteria:

* Documented HIV infection
* 18 years of age or older and weigh at least 40 kg
* Two plasma HIV RNA levels below the limit of quantification (one at least 90 days prior to the screening visit and one within 30 days of the patients baseline visit)
* Currently receiving a standard-of-care HAART regimen with at least one agent being dosed twice-daily or more frequently

Exclusion Criteria:

* Pregnancy, breastfeeding or plans to become pregnant during the study period
* Any prior documented virologic failure to one or more HAART regimens
* Active AIDS-defining opportunistic infection or disease
* Proven or suspected acute hepatitis within 30 days prior to study entry
Intermittent Fasting Versus Diet to Stop Hypertension on Metabolic Risk Profile in Nonalcoholic Fatty Liver Patients

This study was conducted to compare between the effect of intermittent fasting and diatery approach to stop hypertension on metabolic risk profile in nonalcoholic fatty liver patients.

Non-alcoholic fatty liver is a liver disease linked to obesity, insulin resistance, type 2 diabetes, hypertension, hyperlipidemia, and metabolic syndrome. The subtype, non-alcoholic steatohepatitis, can lead to liver fibrosis, cirrhosis, hepatocellular carcinoma, and liver transplantation. The prevalence of Non-alcoholic fatty liver disease is increasing at the same rate as obesity, with the global prevalence estimated at 25%. By 2020, the burden of Non-alcoholic fatty liver is expected to exceed that of communicable disease in most regions.

Eligibility Criteria:
Inclusion Criteria:

* Non-alcoholic fatty liver patients diagnosed by radiological ultrasound
* BMI \>30
* All patients are sedentary lifestyle with little or no exercise.
* High lipid profile (total cholesterol \> 200, LDL \> 130, TAGs \> 150) patients by laboratory investigation.
* High fasting insulin level \> 20mlU/mL \& high fasting Glucose level \>100, HbA1c \> 5.7 \& high HOMA- IR \> 2.5 patients by Laboratory investigation.
* High inflammatory markers (IL6) patients.
* Age ranged from 30 to 40 years old.

Exclusion Criteria:

* Alcoholic fatty liver patients.
* Cirrhosis patients.
* Diabetes patients.
* Cognitive impaired patients.
* History of epilepsy patients.
* Cardiac pacemaker patients.
* Anemic patients
* pregnancy
Electronic Register on Advanced Heart Failure and Transplantation di Cuore

The goal of this observational study is to create an electronic registry of patients diagnosed with Advanced Heart Failure or Heart Transplant, starting from 01/01/1985 and to assess the incidence of Advanced Heart Failure and Heart Transplant, and characterize patients affected by the first or undergoing the second procedure, starting from 01/01/1985. The primary outcomes are:

* Hospitalization for cardiovascular cause
* Death

Heart failure is a pathological condition characterized by high morbidity and mortality, and it leads to a significant worsening of the quality of life for patients. The treatment of heart failure involves various options; the goal is to slow down the progression of the disease, reduce hospitalizations, increase survival, and reduce symptoms in order to improve the quality of life. Treatments range from pharmacological therapy to lifestyle changes, from device implantation to heart transplant surgery. Early diagnosis and treatment often help reduce symptoms, and many patients with heart failure can return to an active life. Patients with heart failure must undergo regular check-ups to assess their general physical condition and the status of the disease. It is therefore essential to evaluate and systematize the different therapies.

This study is both retrospective and prospective

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Ability to provide informed consent
* Diagnosis of Advanced Heart Failure or Heart Transplant

Exclusion Criteria:

* none
The Cohort Study of Pediatric Cataract

This retrospective-prospective bidirectional cohort study aims to observe ocular parameter changes, different surgical/vision recovery strategies and postoperative adverse effects among young children with cataract. The influence on psychology and cognitive function will be taken into consideration as well.

Pediatric cataract, one of the leading causes of childhood blindness globally, is complex and of great difficulty in treatment. Pediatric patients with cataract (congenital, traumatic or complicated) are enrolled. In this study, investigators will compare ocular parameter changes, different surgical/vision timing or recovery strategies and adverse effects among young children （age \< 18 yo）before and after cataract surgery. The influence on psychology and cognitive function will be taken into consideration as well. The whole blood samples of participants and parents are collected and retained in our biobank for gene sequencing, hoping to explore the genetic factors in association with pathogenesis. For children received cataract surgery, samples of partial anterior capsular tissue and 1 ml aqueous humor were collected during operation for further analysis. Multimodal artificial intelligence analyses are performed to establish accurate diagnosis/treatment scheme and disease prediction model.

Eligibility Criteria:
Inclusion Criteria:

* aged \< 18 yo at the 1st visit unilateral or bilateral cataract agree to participant in this study and sign the informed consent

Exclusion Criteria:

* adults
A Survey on Attitudes on Financial Incentives

The study concerns a survey of attitudes of the public on issues around personal responsibility for health and the use of financial incentives to promote health in the U.S. and Germany. All data are gathered anonymously through online platforms. Two separate professional panel providers are used for access to members of the public. All participants are people who have voluntarily joined a survey panel in the past through an informed consent process and currently serve as panel members.


Eligibility Criteria:
Inclusion Criteria:

* none other than age

Exclusion Criteria:

* none other than age
A Multicenter Study to Evaluate a Risk-adapted Strategy for Treatment of Extra Cranial Non Seminomateous Malignant Germ Cell Tumour in Children and Adolescent

The main objective is to assess the benefit-risk ratio of a risk-adapted strategy for treatment of extra cranial NSMGCT in children and adolescent.

Two different situations will be considered:

* in NSMGCT patients treated with cisplatin-based chemotherapy, the objective is to maintain a 2-year progression-free survival rate \>80% despite a limitation of the number of course of chemotherapy (≤4) after the achievement of a clinical and biological response (primary endpoint);
* in children over 10 years with testicular or extragonadal NSMGCT, the objective is to improve the overall survival by systematically classifying the patients in high-risk group to allow a dose intensification.

Eligibility Criteria:
Inclusion Criteria:

* Extra cranial non seminomateous malignant germ cell tumour (NSMGCT) except pure immature teratoma.
* Age ≤ 18 years.
* Affiliation with a social security scheme.
* Signed informed consent by parents
* Effective contraception during the study if relevant .

Exclusion Criteria:

* Previous chemotherapy
* Contraindications to study treatments
* Patient who cannot follow medical surveillance due to geographical, social, or psychological reasons
* Pregnant and breast feeding women