cyrilzakka/clinical-trials huggingface dataset:
Docetaxel Plus Carboplatin in Treating Patients With Advanced Cancer of the Esophagus

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of docetaxel plus carboplatin in treating patients who have advanced cancer of the esophagus.

OBJECTIVES: I. Evaluate the objective response rate in patients with advanced squamous cell carcinoma of the esophagus treated with carboplatin and docetaxel. II. Assess the toxicity of this regimen in these patients. III. Assess the time to progression and overall survival of this patient population.

OUTLINE: Patients receive docetaxel IV over 1 hour on day 1, followed by carboplatin IV over 15-30 minutes on day 1. Treatment is repeated every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until year 2, every 6 months during years 2-5, and then annually thereafter until death.

PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study at a rate of 30 patients per year.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed metastatic or incurable, locally advanced squamous cell carcinoma of the esophagus Measurable disease outside of a previously radiated field required

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal SGOT no greater than 2 times upper limit of normal Renal: Creatinine normal Cardiovascular: No congestive heart failure or angina pectoris, even if medically controlled No prior myocardial infarction within the past year No clinically significant conduction system abnormalities, such as 2nd or 3rd degree heart block or bundle branch block Pulmonary: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception No active infections or medical illnesses that are uncontrolled No second malignancy other than previously treated nonmelanoma skin cancer or carcinoma in situ of the cervix or a prior malignancy from which patient has been disease free for past 3 years Caloric intake greater than 1500 calories/day Fluid intake greater than 1500 mL/day

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified
A Phase 2 Study of MP-376 to Prevent Acute Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients

Patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from frequent and recurrent acute exacerbations (AECB) which are associated with enormous healthcare expenditures and significant morbidity, specifically an increased risk of death, a decline in pulmonary function and a significant change in quality of life. Bacteria appear to have an important role in acute exacerbations in chronic bronchitis and COPD. Studies of acute exacerbations in COPD have shown a reduction in bacterial load with prolonged exacerbation-free interval. In addition, recent studies indicate that acquisition of a new strain of H. influenzae, M. catarrhalis, S. pneumoniae or P. aeruginosa are responsible for many of these exacerbations. Chronic inflammation and bacterial infection predispose many patients to frequent and recurrent acute exacerbations.

Mpex believes that intermittent administration of inhaled MP-376 in high risk patients will decrease the incidence of acute exacerbations by both by lowering the organism burden, and resultant inflammation, as well as pre-emptive eradication of any newly acquired bacterial strains.

This study will be a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and efficacy of MP-376 inhalation solution given daily for 5 days in a 28 day treatment cycle to COPD patients.

Study with completed results acquired from Horizon in 2024.

Eligibility Criteria:
Inclusion Criteria (selected):

* \> 40 years of age
* History of COPD
* Forced expiratory volume in 1 second (FEV1) \</= 70% of predicted and FEV1/Forced vital capacity (FVC) \</= 0.7 value at screening
* Have at least two acute exacerbation episodes in the proceeding year
* Clinically stable with no changes in health status within the last 30 days
* Lifetime smoking history of at least 10 pack-years
* Willing and able to use a daily electronic diary

Exclusion Criteria (selected):

* Use of any systemic or inhaled antibiotics within 30 days prior to baseline
* History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
* Creatinine clearance \< 40 mg/ml/min, AST, ALT \>/= 5 x upper limit of normal (ULN) or total bilirubin \>/= 3 x ULN at Screening
Collagen-targeted PET Imaging for Early Interstitial Lung Disease

The goal of this study is to investigate the ability of \[68Ga\]CBP8 to detect collagen deposition in early interstitial lung disease.

\[68Ga\]CBP8, is a PET imaging probe which selectively binds collagen type I. Collagen deposition is a pivotal event in the development of pulmonary fibrosis. \[68Ga\]CBP8 binds collagen with high affinity and has excellent pharmacological and pharmacokinetic profiles. \[68Ga\]CBP8 was shown in a mouse model to be effective for detecting lung fibrosis and response to treatment. In addition, \[68Ga\]CBP8 can detect increased collagen in the lungs of patients with idiopathic pulmonary fibrosis.

The goals of this study are:

1. To determine whether collagen deposition as assessed by \[68Ga\]CBP8-PET MRI can detect increased collagen deposition in early interstitial lung disease and
2. if the degree of \[68Ga\]CBP8 uptake predicts subsequent disease progression.

Eligibility Criteria:
Inclusion Criteria:

Group 1: First degree relatives of a family member with pulmonary fibrosis (n=8)

* Age greater than 40 years
* Have the ability to give written informed consent
* First degree relative of a family member with pulmonary fibrosis
* No known history of interstitial lung disease
* No tobacco use within the prior 6 months.

Group 2: Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) (n=22)

* Age greater than 40 years
* Have the ability to give written informed consent
* ILAs or early ILD (defined by presence of reticular markings and / or traction bronchiectasis but absence of a definite UIP pattern)
* No tobacco use within the prior 6 months.

Exclusion criteria:

* Electrical implants such as cardiac pacemaker or perfusion pump
* Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing
* Historical eGFR of less than 30 mL/min/1.73 m2
* Pregnant or breastfeeding (a negative quantitative serum hCG pregnancy test is required for females having child-bearing potential before the subject can participate)
* Claustrophobic reactions
* Research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months)
* Unable to lie comfortably on a bed inside the MR-PET
* BMI \> 33 (limit of the PET-MRI table)
* Determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening visit and/or during study procedures)
* Pneumonia or other acute respiratory illness within 6 weeks of study entry
* Parenchymal lung disease except for ILD/ILAs or emphysema
* Acute exacerbation of ILD within the prior 6 months
* VATS within the prior 6 months
* Prior radiation therapy to the thorax
* Known allergy to gadolinium.
A Quality Improvement Plan for Hypertension Control

The study hypothesis is that the implementation of a plan for quality improvement at the primary care health teams taking care of hypertensive patients, will increase the level of blood pressure control among those patients.

The study is to compare the results on the hypertension control between two groups of primary health care teams. The intervention group will undertake a quality improvement plan for hypertension control, in which the following aspects will be included in the intervention:

Specific training programme on how to diagnose hypertension , and measure blood pressure correctly To send feed back information to primary care health professionals about poorly controlled hypertensive patients An audit will be performed, every 6 months, to see the adhesion to the recommended clinical guidelines , and the information will be diffused among the participant primary health care professionals Each participant primary health care team will have a designated reference person, that will provide support on any doubts on the programme implementation.

The non intervention group will follow hypertensive patients following the same clinical practice guide as the intervention group, with no intervention on the primary health care professionals

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with hypertension before January 1st, 2006
* Patients assigned at the primary health team participating, and with clinical electronic records

Exclusion Criteria:

* Patients diagnosed with hypertension after January 1st, 2006
* Patients under 18 years of age
* Patients with a diastolic blood pressure higher than systolic blood pressure as recorded in the clinical records
A Drug Monitoring Study on PEG-asparaginase Treatment in Children Diagnosed Acute Lymphoblastic Leukaemia

Asparaginase is an important drug i the treatment of childhood leukaemia.

The aim of this project is to study the pharmacokinetics, pharmacodynamics and antibody development and hypersensitivity reactions during prolonged PEG-asparaginase treatment.

Study part 1) Asparaginase pharmacokinetics and pharmacodynamics during prolonged PEG-asparaginase treatment: A NOPHO ALL-2008 study

Study part 2) Asparagine depletion in cerebrospinal fluid: A NOPHO ALL-2008 study

Study part 3) A characterization of PEG-asparaginase hypersensitivity in children treated according to the NOPHO ALL 2008 protocol

Perspectives: New knowledge about PEG-asparaginase treatment regarding dosing, dosing interval, adverse effects and EFS, which may lead to improved future therapy

Patients: Children diagnosed with acute lymphoblastic leukaemia in the Nordic Countries


Eligibility Criteria:
Inclusion Criteria:

Children aged between 1 and 18 years old, diagnosed ALL and treated according to the NOPHO-ALL 2008 protocol and who have accepted to participate in this study

Exclusion Criteria:

Children that does not attend the NOPHO-ALL 2008 protocol but receives standard treatment
Compont - Varicose Veins of the Lower Extremities

The purpose of this clinical trial is to evaluate the effectiveness and safety of Medical Adhesive produced by Beijing Compont Medical Devices Co., Ltd. in the treatment of varicose veins in the lower extremities.

The main questions it aims to answer is: What medical problems do participants have when using tissue glue? Researchers will compare Medical Adhesive to ClosureFast Endovenous Radiofrequency Ablation (RFA) Catheter (produced by Medtronic Inc. to see if Medical Adhesive works to treat varicose veins in the lower extremities.

Participants will:

Treated with closed varicose veins of the lower extremity by Medical Adhesive or ClosureFast.

Return to the hospital at 1, 12, and 24 weeks postoperatively for Doppler ultrasound, and at 4, 12, 24 weeks postoperatively for venous scoring.


Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed as great saphenous vein varices. (This operation only dealt with one side varicose veins of the lower extremities.)
* CEAP is graded C2-C6.
* Doppler ultrasound confirmed the patency of deep veins of lower limbs.
* Sign informed consent, voluntarily participate in the trial and follow up as required

Exclusion Criteria:

* A history of lower extremity deep vein thrombosis or pulmonary embolism
* Recurrent varicose veins
* The diameter of target lesion of the great saphenous vein less than 2 mm or more than 15 mm
* The great saphenous vein is severely distorted or tuberculated at the root
* Sepsis or septicemia
* Allergic to n-butyl cyanoacrylate
* The distance between the skin and the target vessel wall of the great saphenous vein less than 5 mm
* Severe cardiopulmonary disease, shock, coma or multiple organ failure
* Lactating or pregnant women
* Participated in other clinical trials within 1 month before surgery
* The researchers considered it unsuitable for inclusion
Efficacy of Exercise Program on Osteosarcoma Patients

This study will be conducted to investigate the effect of selected therapeutic exercises compared to standard exercise program in improving ROM, muscle strength and functional outcomes in distal femur osteosarcoma patients who have undergone tumor resection and modular knee endoprosthesis.

Osteosarcomas (OS) are the most common primary bone tumor and third most common cancer among children and adolescents after lymphomas and brain cancers (Wang et al., 2018; Luetke et al., 2014).

It is a primary malignant bone tumor with a worldwide incidence of 3.4 per million people per year (Mirabello et al., 2009). They are characterized by the production of osteoid, or immature bone, by malignant mesenchymal cells (Wang et al., 2018; (Luetke et al., 2014).

Patients displayed some persisting physical difficulties including incapability to perform active range of motion (ROM), decreased muscle strength, altered gait and sit-to-stand patterns, yet they maintained high levels of emotional acceptance and coping. A surprising but important finding was the persisting hip weakness in both operated and non-operated limbs, which extends up to 42 months after resection around the knee. This indicates that continued rehabilitation programs emphasizing hip strengthening should be considered for these patients, even years after surgery (Beebe et al., 2009). Furthermore, ROM exercises, strengthening exercises and balance exercises improve overall Quality of life (QOL) for these patients (Marchese et al., 2006).

Eligibility Criteria:
Inclusion Criteria:

1) Patients diagnosed as distal femur osteosarcoma. 2) Age of the patient from 15-50 years old 3) Patients undergoing tumor resection and knee endoprosthetic reconstruction six weeks ago. 4) Both gender

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Exclusion Criteria:

1) Lung and bone metastasis 2) End stage patients receiving palliative chemotherapy 3) Patients undergoing L.L amputation or rotationplasty (any surgical procedures rather than knee endoprosthetic reconstruction). 4) Local tumor recurrence 5) Sever psychiatric illness 6) Heart disease or any condition that prevent the patient from participation in exercise

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Oxygen Atomizing Inhalation of EGCG in the Treatment Interstitial Pneumonia in Cancer Patients

Epigallocatechin-3-gallate (EGCG) is a major polyphenol of green tea that possesses a wide variety of actions, such as anti-inflammatory, anti-fibrotic, pro-apoptotic, anti-tumorous, and metabolic effects via modulation of a variety of intracellular signaling cascades. In addition, preclinical studies have also emphasized the antiviral activity of epigallocatechin-3-gallate (EGCG), including SARS-CoV-2.

In previous studies, we found that EGCG can prevent and cure radiation-induced normal tissue damage in tumor patients. In clinical studies, we found that EGCG can prevent and treat radiation-induced acute radiation esophagitis, acute radiation skin injury, acute radiation oral mucositis with high safety. Thus, we designed this phase I-II clinical study in order to investigate the possible role of EGCG in the treatment interstitial pneumonia in tumor patients.

In this phase I study, subjects were divided into four dose groups according to the improved Fibonacci method and were given different doses of EGCG to evaluate adverse events. At the same time, the researchers conducted a phase II study of EGCG in tumor patients with interstitial pneumonia. The Phase II study was conducted with a randomized, controlled, placebo dose determined by Phase I. the subjects were divided into two groups (experimental group and placebo group). To observe the effectiveness of EGCG, the researchers will use both clinician assessment and patient self-assessment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed malignant tumors by pathology or cytology
* COVID-19 with a confirmed positive polymerase chain reaction or antigen test result for SARS-CoV-23
* Moderate pneumonia, according to the diagnosis and treatment standard of COVID-19 in Peking Union Medical College Hospital
* Pulmonary function of the patient can be treated with aerosol inhalation for 5-7 days

Exclusion Criteria:

* Current or recent progresses rapidly and may develop into a Critical illness with coronavirus in a short period of time
* Caused by other viruses such as cytomegalovirus, as well as pneumocystis pneumonia, pulmonary edema, aspiration pneumonia and acute interstitial pneumonia
* Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the participant from adhering to the protocol or would increase the risk associated with study participation
* Need systemic use of immune suppressive agents
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants

Primary Objective:

* To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP\~T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month after a three-dose primary series.

Secondary Objectives:

* To describe in each group the immunogenicity parameters one month after the three-dose primary series.
* To describe safety profile after each vaccination in both groups.


Eligibility Criteria:
Inclusion Criteria :

* Infant of either gender, aged 50 to 70 days inclusive
* Mother is negative for HBsAg
* Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg
* Written informed consent form signed by at least one parent or by another legal representative and an independent witness
* Parent/legal representative able to attend scheduled visits and to comply with the trial procedures during the entire duration of the trial.

Exclusion Criteria :

* Axillary temperature ≥37.1°C on the day of inclusion
* Current or planned enrolment in another clinical trial during the clinical trial period
* Known mother's history of Human Immunodeficiency Virus (HIV) infection
* Known immunodeficiency (congenital or acquired) or induced by immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth, or systemic corticosteroids in the last 4 weeks (≥0.5 mg per kilogram and per day equivalent prednisolone and lasting more than 7 days)
* Receipt of blood-derived products since birth
* Acute symptoms or severe chronic illness (e.g. cardiac, renal insufficiency, diabetes, auto immune disorders, congenital defect) that may interfere with conduct or completion of trial
* Occurrence of seizures since birth
* Hypersensitivity to any of the vaccine components
* Coagulopathy contraindicating intramuscular injection
* History of (documented) clinical or serological/microbiological confirmed infection due to pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b (Hib) or hepatitis B (HB) diseases
* History of vaccination against pertussis, tetanus, diphtheria, polio, Hib or HB infections
* Vaccination within the last 4 weeks.
Adult Oxytocin Study

In this study, investigators will examine the behavioral effects and neurophysiological mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset schizophrenia. Such research is a necessary first step towards identifying whether intranasal oxytocin administration can serve as an adjunct treatment for social impairments in schizophrenia.

Aim 1: To quantify the effects of exogenous oxytocin on social cognition and behavior in patients with recent-onset schizophrenia.

Hypothesis A: Patients and healthy comparison subjects will show enhanced social cognition (e.g., improved interpretation of paralinguistic and emotional cues, such as those involved in emotional or sarcastic communication) after administration of oxytocin versus placebo.

Hypothesis B: Patients and healthy comparison subjects will show increased attention to others' eyes and patients will exhibit increased facial affect expressivity after administration of oxytocin versus placebo.

Aim 2: To examine the effects of exogenous oxytocin on persistent negative symptoms in schizophrenia (PNS) activity in patients with recent-onset schizophrenia.

Hypothesis A: Patients and healthy comparison subjects will demonstrate increased PNS activity during social tasks after administration of oxytocin versus placebo.

Hypothesis B (exploratory): Patients and healthy comparison subjects' improvements in social cognition and behavior will be predicted by the degree to which oxytocin increases their PNS activity.


Eligibility Criteria:
Inclusion Criteria for Patients:

* 18 to 65 years of age
* English Speaking
* Meet Diagnostic and Statistical Manual (DSM)-IV criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder.
* No or at most only minor changes to medications in the past week
* Able to use nasal spray
* Must be capable of providing informed consent

Inclusion Criteria for healthy volunteers:

* 18 to 65 years of age
* Clinically stable
* No diagnosis of mental disorder according to DSM-IV TR.
* Able to use nasal spray
* Must be capable of providing informed consent
* English Speaking

Exclusion Criteria:

* Active substance abuse or dependence as determined by a Urine Toxicology Drug Screening
* A current DSM-IV diagnosis of any disorder other than schizophrenia
* Medical conditions (atrophic rhinitis, recurrent nose bleeds and cranial-surgical procedures (hypophysectomy), congestion or sinus problems) that could interfere with the study as per the opinion of the investigator
* Hearing deficits
* Pregnancy
* Severe brain trauma
Giessen Pulmonary Hypertension in Lung Cancer Registry

The aim of this study is to investigate the frequency and implications of pulmonary hypertension in lung cancer patients. To do so, data will be collected from all lung cancer patients at the university hospital Giessen. All data will be analyzed for possible hints of pulmonary hypertension as a comorbidity in lung cancer patients. All information will be generated from the regular guidelines based course of treatment and there will be no interventions. This study will serve as a prospective register for all lung cancer patients treated at the university hospital Giessen.


Eligibility Criteria:
Inclusion Criteria:

* Patient with lung cancer at the University of Giessen lung Cancer Center.

Exclusion Criteria:

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