cyrilzakka/clinical-trials huggingface dataset:
Giessen Pulmonary Hypertension Registry and Biobank

Giessen Pulmonary Hypertension Registry and Biobank

Long-term transplant-free survival and its determinants will be investigated in patients with Pulmonary Hypertension (diagnosed by right heart catheterization) within a prospective registry at a single referral center in Giessen, Germany.

Eligibility Criteria:
Inclusion Criteria:

* Right heart catheterization for PH diagnosis in Giessen

Exclusion Criteria:

* informed consent missing
Monoclonal Antibody Plus Chemotherapy in Treating Patients With Metastatic Breast Cancer That Overexpresses HER2

RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to make tumor cells stop dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of trastuzumab plus paclitaxel in treating patients who have metastatic breast cancer that overexpresses HER2.

OBJECTIVES:

* Determine the pharmacokinetics and pharmacodynamics of trastuzumab (Herceptin) and paclitaxel in patients with HER2-overexpressing metastatic breast cancer.
* Provide access to trastuzumab and paclitaxel for these patients.

OUTLINE: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes and paclitaxel IV over 1 hour weekly. Patients receive trastuzumab alone during course 1 and then in combination with paclitaxel during subsequent courses. Courses repeat every 4 weeks until patients achieve a sustained complete response of 8 weeks or disease progression occurs.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed metastatic breast cancer with HER2 overexpression
* Radiographically or physically measurable disease that can be biopsied safely under local anesthesia
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Sex:

* Male or female

Menopausal status:

* Not specified

Performance status:

* ECOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Neutrophil count at least 1,000/mm\^3
* Platelet count at least 75,000/mm\^3

Hepatic:

* Bilirubin no greater than 3 times upper limit of normal (ULN)
* AST and ALT no greater than 5 times ULN

Renal:

* Not specified

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior trastuzumab

Chemotherapy:

* Not specified

Endocrine therapy:

* At least 2 weeks since prior hormonal therapy
* No concurrent hormone receptor therapy (e.g., tamoxifen or armidex)

Radiotherapy:

* Localized palliative external beam radiotherapy allowed

Surgery:

* Not specified

Other:

* Concurrent bisphosphonates allowed
Evaluating Neostigmine Effect on Reducing Gastric Residual Volume as Compared With Metoclopramide and Ondansetron

One big problem in mechanically ventilated ICU patients is delayed gastric emptying. Delayed gastric emptying in these patients, causes intolerance and high gastric residual volume (GRV) that can lead to abdominal distention, vomiting, increased aspiration risk and consequently increased the length of hospital stay.

In this study, investigators will evaluate Neostigmine's effect in reducing GRV in mechanically ventilated patients and compare its effect with metoclopramide and Ondansetron

.

It has been shown that delayed gastric emptying and high GRV in critically ill patients are associated with increased mortality in these patients. Different kinds of drugs including metoclopramide, erythromycin and cisapride are used, but none of them had conclusive evidence of better eﬀects on each other. Moreover, complications such as dysrhythmia and extrapyramidal side eﬀects limit the use of these drugs.

Another drug that can be used to increase gastric emptying in critically ill patients is neostigmine. Although several studies have evaluated the efficacy of neostigmine on postoperative ileus, very few studies have evaluated the effect of this drug on GRV in ICU patients.

The aim of the current study will be to compare the effects of Neostigmine on gastric residual volume in mechanically ventilated patients in the intensive care unit. A comparative controlled study by Ondansetron.

Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated ICU patients
* With nasogastric tube feeding
* Gastric Residual Volume \>120 mL (3hours after the last gavage)

Exclusion Criteria:

* History of diabetes
* Heart block
* Bradycardia (heart rate \<60/min)
* Systolic blood pressure less than 90 mm Hg
* Renal insufficiency
* Using any prokinetic agents such as erythromycin or cisapride within 8 hours before study initiation
* Recent surgery (10 days or less) on the stomach or digestive system
* pregnancy and lactation
* Occurrence of extrapyramidal side effects
* Gastrointestinal (GI) bleeding
Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients

The safety and efficacy at 100 mg once daily for oral dose of sitaxentan sodium were demonstrated in the STRIDE clinical trial program. Sitaxentan sodium was approved in the EU, Canada and Australia. In this study, the long-term safety and efficacy after administrations of sitaxentan sodium at a dose of 100 mg alone or in combination with another medication will be investigated in Japanese PAH patients.


Eligibility Criteria:
Inclusion Criteria:

* Subject who completed the B1321052 study as planned.

Exclusion Criteria:

* Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure \>160 mm Hg or sitting diastolic blood pressure \>100 mm Hg at Screening.
* Has hypotension defined as systolic arterial pressure \<90 mm Hg after sitting for 5 minutes at Screening.
Pro-calcitonin Marker as Indicator of Ischemia in Patients With Complicated Coronary Intervention.

The aim of this study is to determine on preliminary basis weather an elevated pro-calcitonin level can be used to assess ischemia as a result of coronary artery complications during percutaneous coronary intervention (PCI).

Pro-calcitonin is a type of protein found in the blood. This protein has recently be found to be elevated in patients with diseases of the arteries of the heart such as heart attack.

Percutaneous coronary intervention (PCI) is widely used in the treatment of many patients with blockage in the arteries of the heart.

the investigators normally used a marker called troponin after cardiac catheterization. However, this marker may not be specific.

Pro-calcitonin has been found to be a useful marker for the detection of myocardial injury. the value of Pro-calcitonin as a marker for the identification of myocardial damage undergoing PCI has not yet been studied.

Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years old.

Exclusion Criteria:

* no consent.
* suspicion of sepsis.
* Patients with elevated troponin or procalcitonin before enrollment.
* patients who had non-elective angioplasty (e.g. rescue angioplasty, primary angioplasty, salvage angioplasty, or emergency angioplasty)
Safety and Immunogenicity of HPV Vaccine Administered Intradermally and Intramuscularly Via Needle-Free Injection System

The goal of this clinical trial is to evaluate the safety and immunogenicity of an HPV Vaccine (Gardasil) delivered by intramuscular needle-free injection and intradermal needle-free injection. The main question it aims to answer is:

* Is intramuscular and intradermal needle-free injection of Gardasil safe?
* Does intramuscular and intradermal needle-free vaccination with Gardasil illicit an immune response?

Participants will:

* Receive Gardasil by intramuscular needle-free injection, intradermal needle-free injection, or needle and syringe injection.
* Provide blood samples
* Complete physical exams
* Complete diaries


Eligibility Criteria:
Inclusion Criteria:

* Female between the age of 12 years and 13 years, inclusive. (Female 7th grade junior high school students in Indonesia)
* Clinically healthy, as established by medical history and physical examination before entering the study.
* Not pregnant at the time of vaccination.
* Able to provide informed consent and assent.
* Able to comply with the study.

Exclusion Criteria:

* Previous vaccination against HPV.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days prior to study enrollment, or planned use during the study period.
* Administration of any vaccine within 30 days prior the study enrollment, or within 30 days of study vaccination visits.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the study enrollment, or planned use during the study period.
* Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
* History of allergic disease, suspected allergy, or reactions likely to be exacerbated by any component of vaccine, including yeast.
* History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, autoimmune disease. Participants with medically stable, well controlled autoimmune disease may be permitted.
* Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection.
* Received immunoglobulins and/or blood product within 90 days preceding enrollment, or planned use during the study period.
* Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., axillary temperature \<37.5°C.
* Any condition that may interfere with ability to comply with trial procedures, as assessed by the Investigator.
68Ga DOTA-TATE PET/CT in Somatostatin Receptor Positive Tumors

The primary objective of the study is to evaluate 68Ga-DOTA TATE PET/CT for staging and monitoring response to chemotherapy in patients with carcinoid, neuroendocrine tumors, medullary thyroid cancer and other cancers expressing somatostatin receptors.


Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years-old at the time of radiotracer administration
* Provides written informed consent
* Known diagnosis of NET or suspected SSTR positive tumors by 111In-Octreotide scan, 18FDG-PET, or MRI of the abdomen when clinically indicated
* Karnofsky score greater than 50 or ECOG Performance Status 0-2
* Women of childbearing age must have a negative pregnancy test at screening/baseline
* Able to remain still for duration of each imaging procedure (about one hour)

Exclusion Criteria:

* Less than 18 years-old at the time of radiotracer administration
* Pregnant or nursing
* Serum creatinine \>3.0 mg/dL
* Hepatic enzyme levels more than 5 times upper limit of normal.
* Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments.
* Inability to lie still for the entire imaging time
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
An Intervention to Impact Cardiovascular Implantable Electronic Device Lead Models Implanted in Veterans

This study will evaluate if an intervention using academic detailing and audit and feedback impacts the specific pacemaker or implantable cardioverter-defibrillator (ICD) lead models implanted in Veterans.

This study will identify Department of Veterans Affairs (VA)-based cardiac electrophysiologists at three Veterans Integrated Service Networks (VISNs). Each cardiac electrophysiologist will participate in a videoconference during which time an academic detailing and audit and feedback intervention will be implemented, which will include details and recommendations about lead selection for implantation, based on cardiovascular implantable electronic device (CIED: pacemaker and implantable cardioverter-defibrillator \[ICD\]) lead-specific failure rates for lead models currently available in clinical practice. The cardiac electrophysiologist will also be presented with quantitative data about the individual physician's facility's implants and national data on implants over the past year. These data will be shared in advance, with time for questions and discussion. The electrophysiologist will be asked if anything can be done to facilitate selection of CIED lead models with the statistically and clinically significantly lower failure rates.

Then, over the subsequent 3 months, a quantitative evaluation of the CIED lead models implanted will be evaluated, comparing changes in lead model selection among the electrophysiologists receiving the intervention to a control group of all VA cardiac electrophysiologists who do not receive the intervention. Subsequently, semi-structured interviews will be conducted to assess reasons for changes, or lack thereof, in CIED lead model selection - including barriers and facilitators. Finally, quantitative data will be included to each of the cardiac electrophysiologists, with additional feedback.

Eligibility Criteria:
Inclusion Criteria:

* Department of Veterans Affairs-based cardiac electrophysiologists who implant cardiovascular implantable electronic devices at three Veterans Integrated Service Networks (VISNs)

Exclusion Criteria:

* Not willing to participate in the study
Body Composition and Prognosis in Head and Neck Squamous Cell Carcinoma (HNSCC)

This is a retrospective study in patients with cancer of the oral cavity, pharynx, and larynx. Imaging exams of these patients will be analyzed with the objective of developing and validating a clinically applicable method for evaluation of cachexia and/or sarcopenia in a patient with head and neck cancer from musculature imaging of the neck. Indeed, the prognostic influence of body composition will be evaluated.

Epidermoid carcinoma (SCC) is the predominant histology of cancers of the oral cavity, pharynx, and larynx. In Brazil, 11,200 new cases of oral cavity cancer are estimated in men and 3,500 in women for each year of the 2018-2019 biennium. The disease causes high mortality and morbidity, affecting swallowing and dysphagia, leading to weight loss and cachexia. Cancer cachexia is marked by involuntary muscle loss leading to progressive functional impairment and can not be reversed by traditional nutritional support. Recent publications show that muscle mass can predict certain outcomes such as survival. Methods for assessing body composition have been developed and validated for research, and the area of a skeletal muscle, which can be measured by cross-sectional images, is a valid marker of total body mass. The CT evaluation of the region of the third and fourth lumbar vertebra (L3-L4) are accurate and accepted as a method for evaluating body composition. However, given the locoregional nature of the dissemination of this SCC, usually the L3-L4 level is not available on CT, and this is a limitation for the use of CT to assess cachexia in these patients. This study will be divided into three steps. In the first step, 20 patients with cross-sectional CT images of patients with head and neck cancer diagnosis will be selected to verify the intra-class variation at different evaluation times. The second step aims to evaluate the correlation of the muscular area obtained through the L3 region with the area of the neck muscles. The third step will evaluate the prognostic role of the neck muscle area of HNSCC patients. The area of the neck muscle of the first CT scan obtained prior to the beginning of treatment will be evaluated and the ratio of this area with the survival rate will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have histological or cytological evidence of oropharynx squamous cell carcinoma, oral cavity, larynx or hypopharynx, locally advanced treated only at Sao Paulo Cancer Institute (ICESP).

Exclusion Criteria:

* patients with no tomography available.
* head and neck cancer with tumor at other sites such as thyroid, paranasal sinus, skin and nasopharynx, or other histology other than squamous cell carcinoma
Post Authorization Safety Profile of Booster IndoVac COVID-19 Vaccination

This study is Post Authorization Safety Study (PASS) Phase IV of Booster IndoVac COVID-19 Vaccination

This study is Post Authorization Safety Study (PASS) Phase IV, to assess any local and systemic reaction after immunization with IndoVac using retrospective cohort study trial design to assess safety profile following IndoVac booster vaccine in healthy populations aged 18 years and above.

Eligibility Criteria:
Inclusion Criteria:

1. Clinically healthy subjects aged 18 years and above
2. Subjects have been injected with IndoVac booster.
3. Minimum 6-month interval from primary or booster COVID-19 vaccination.
4. Subjects have been informed properly regarding the study and signed the informed consent form.

Exclusion Criteria:

1. Subjects concomitantly enrolled or scheduled to be enrolled in another study when the subjects got IndoVac booster vaccination.
2. Subject's telephone number is invalid or cannot be contacted.
Stretching to Improve Jumping Performance

The study involves comparison of an 8-week plantar flexor stretching program to a shoulder stretching program for improving vertical jump performance in adolescent athletes.

Increasing flexibility may improve vertical jump performance. For example, being able to go deeper into a squat before jumping may allow for greater force development through the range of movement and this may transfer to greater vertical jump height. The study compares plantar flexor stretching to shoulder stretching for improving vertical jump performance in adolescent athletes. Athletes are being stratified by sex and maturity status (before or after estimated age at peak height velocity) and randomized to one of two groups: Plantar flexor stretching (2 sets of 6 stretches, 5 times per week) or the same volume of shoulder stretching. Before and after training, participants are being assessed for vertical jump and landing performance.

Eligibility Criteria:
Inclusion Criteria:

* Currently involved in a sport training program

Exclusion Criteria:

* Current or past injuries that might affect jumping performance or stretching the plantar flexors or shoulder joint
ToleroMune Grass Exposure Unit Study

Grass pollen allergens are recognised as a major cause of allergic diseases in humans and animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen. ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of grass allergy.

This study will look at the efficacy, safety and tolerability of three doses of ToleroMune Grass in grass allergic subjects following challenge with with grass in an Environmental Exposure Unit (EEU).

This study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of ToleroMune Grass in grass allergic subjects with allergic rhinoconjunctivitis. The efficacy of ToleroMune Grass will be explored in subjects using an EEU (Environmental Exposure Unit).

The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 16 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of 4 visits to the EEU at least 3 days before randomisation.

In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to one of four groups and will receive treatment every 2 weeks (±2 days) for 14 weeks.

In Period 3, Post Treatment Challenge will consist of 4 visits to the EEU about 25 weeks after the first administration in the treatment period and assessments will be performed identical to those at the baseline challenge. Follow-up will be conducted 3-10 days after PTC.

Eligibility Criteria:
Inclusion criteria

* Male or female, aged 18-65 years.
* Minimum 2-year documented history of rhinoconjunctivitis on exposure to grass.
* Positive skin prick test to grass allergen.
* Minimum qualifying rhinoconjunctivitis symptom scores

Exclusion criteria

* History of asthma.
* A history of anaphylaxis to grassallergen.
* Subjects with an FEV1 \<80% of predicted.
* Subjects who cannot tolerate baseline challenge in the EEU.
* Subjects for whom administration of epinephrine is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
* A history of severe drug allergy, severe angioedema or anaphylactic reaction to food.
* A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment).
Afatinib Monotherapy in Patients With ERBB-deregulated Metastatic Urothelial Tract Carcinoma After Failure of Platinum Based Chemotherapy

The purpose of this trial is to assess the anti-tumour activity and safety of afatinib monotherapy in patients with urothelial tract carcinoma carrying ERBB2 or ERBB3 (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family of receptors) mutations or ERBB2 amplifications (Cohort A), and EGFR (Epidermal Growth Factor Receptor) amplification positive tumours (Cohort B), progressing despite previous platinum based chemotherapy, and thereby to improve their prognosis.

The antitumour activity of afatinib monotherapy in these patients will be assessed by progression free survival rate at 6 months (PFS6). This will be the primary endpoint of the trial. A key secondary endpoint will also be defined, the objective response rate (ORR).


Eligibility Criteria:
Inclusion criteria:

* Recurrent or metastatic urothelial cancer
* Patients must have failed prior platinum based treatment (adjuvant or 1st line)
* Archival tissue sample available for biomarker testing at pre-screening and tissue banking.
* Patients should complete a pre-screening biomarker analysis and should fulfill the following: for Cohort A tumour should show a ERBB2 (epidermal growth factor family receptor 2) or ERBB3 mutation, or ERBB2 gene amplification; for Cohort B tumour should show EGFR (Epidermal Growth Factor Receptor) amplification.
* Further inclusion criteria apply

Exclusion criteria:

* Prior use of EGFR, ERBB2 or ERBB3 targeted treatment
* Chemotherapy within 4 weeks prior to the start of study treatment. Biological therapy or investigational agents within 4 weeks prior to the start of study treatment or prior to passing 5 half-lives, i.e. systemic clearance, whatever comes first
* Known brain metastases or signs hereof, uncontrolled spinal cord compression or leptomeningeal carcinomatosis
* Further exclusion criteria apply