cyrilzakka/clinical-trials huggingface dataset:
FDG PET and DCE-MRI in Predicting Response to Treatment in Patients With Breast Cancer

This clinical trial studies fludeoxyglucose F 18 (FDG) positron emission tomography (PET) and dynamic contrast-enhanced (DCE)-magnetic resonance imaging (MRI) in predicting response to treatment in patients with breast cancer. Comparing results of diagnostic procedures done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

PRIMARY OBJECTIVES:

I. To determine whether detailed kinetic analysis of FDG PET and magnetic resonance (MR) imaging studies for measures of tumor metabolism and blood perfusion can predict response and outcome for breast cancer patients undergoing neo-adjuvant therapy.

II. To compare the in vivo tumor biology associated with responsive and resistant tumors as measured by kinetic changes in FDG PET and MR imaging parameters to tumor subtypes analyzed from assay of pre-therapy biopsy and post-therapy surgical tissue.

OUTLINE:

Patients undergo FDG PET and DCE-MRI 1-2 weeks before prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed breast cancer, determined to be a candidate for primary systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor following completion of neoadjuvant therapy
* Primary tumor 2.0 cm or greater, and/or clinical evidence of axillary disease (palpable N1 or N2 or biopsy proven)
* No obvious contraindications for primary chemotherapy
* Able to lie still for PET and MRI scanning
* Able to understand and willing to sign a written informed consent document and a Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines

Exclusion Criteria:

* Serious systemic illness other than breast cancer
* Contraindication to MRI or history of adverse reaction to gadolinium
* Evidence of distant disease outside of regional lymph nodes
* Pregnant
* Poorly controlled diabetes mellitus (fasting blood glucose \> 200)
* Prior systemic cancer therapy
Safety, Tolerability, and Clinical Activity of ASM-024 Administered to Patients With GOLD 2 or GOLD 3 Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to evaluate the safety, tolerability, and clinical activity of ASM-024 administered as a dry powder for inhalation formulation to patients with GOLD 2 or GOLD 3 COPD.

This is a Phase II, randomized, double-blind, placebo-controlled, two-way crossover study to evaluate the safety, tolerability, and clinical activity of a new, dry powder for inhalation formulation of ASM-024 administered twice daily for 14 days to patients with GOLD-2 or GOLD-3 COPD.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adult aged over 40 yrs with a clinically confirmed diagnosis of COPD at the severity stages of GOLD 2 (moderate) or 3 (severe);
* Stable COPD for 1 month prior to screening
* Stable smoker for at least three months prior to screening, or non-smoker, with a smoking history of ≥ 10 packs years;
* FEV₁ ≥ 30 % and \< 70 % of the predicted normal value;
* Normal 12-lead ECG

Exclusion Criteria:

* Clinically significant illness except COPD or surgery within 8 weeks prior to first administration of the study medication;
* Significant medical history that, in the Investigator's opinion, may adversely affect participation;
* History of allergy or significant adverse reaction to drugs similar to ASM-024, to nicotine, or to cholinergic drugs or any drugs with a similar chemical structure;
* History of hypersensitivity (anaphylaxis, angioedema) to any drug;
* Positive pregnancy test for female subjects;
* Use of medications known to prolong QT/QTc interval;
* Clinically significant 12 lead ECG at screening;
* Clinically significant physical examination or laboratory findings or abnormal vital signs;
* History of alcohol or drug abuse;
* Positive hepatitis B or C or HIV test at Screening;
* Investigational drug within 30 days of Screening; long-acting investigational drug within 90 days of screening;
* Previous exposure to ASM-024; and
* Women of child-bearing potential and male participants unwilling or unable to use accepted methods of birth control.
Reliability and Validity of Pittsburgh Rehabilitation Participation Scale During Robot Therapy

Reliability and validity of Pittsburgh Rehabilitation Participation Scale during robot therapy among patients with stroke


Eligibility Criteria:
Inclusion Criteria:

* patients with stroke or traumatic brain injury
* inpatient in rehabilitation center

Exclusion Criteria:

* brain tumor
* spinal cord injury
Safety, Tolerability and Pharmacokinetics of XW10508 Immediate and Modified Release Formulations in Healthy Adults

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of XW10508 in healthy volunteers.

This is a first-in-human single and multiple ascending oral dose pharmacokinetic and safety study where participants will receive either XW10508 or placebo. Both immediate release and modified release formulations will be assessed. Timed blood samples will be collected to assess the pharmacokinetics after the study drug is ingested by the participants.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female participants who are 18 to 55 years of age, inclusive.
* Participant is willing and able to provide signed and dated written informed consent to participate prior to admission to the study.

Exclusion Criteria:

* Evidence or history of clinically significant (in the opinion of the investigator) gastrointestinal, hepatic, renal, respiratory (e.g., asthma, COPD), cardiovascular (e.g., hypertension), metabolic, psychiatric, neurological, immunological, or endocrine disorders, or allergic disease including drug allergies, including immediate type hypersensitivity to components of the study drug. A history of childhood asthma that has resolved is acceptable.
* Use of tobacco- or nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, patches, vaping device, etc.) within 3 months prior to Day -1 and/or positive urine cotinine test at Screening or Day -1.
* Participant who, for any reason, is deemed by the investigator to be inappropriate for this study; or has any condition which would confound or interfere with the evaluation of the safety, tolerability, pharmacokinetics or pharmacodynamics of the investigational drug; or is unable to comply with the study protocol.
Assessment of DAFILON® Suture Material for Skin Closure

In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon®) will be evaluated for skin closure in adult and pediatric patients. The aim of the study is to collect clinical data on the performance of Dafilon® for skin closure. The results of this study will generate further clinical evidence for the use and the benefit of a non-absorbable surgical suture material produced from polyamide. Furthermore, the proactive collection of clinical data for Dafilon® suture will support the maintenance of the suture material on the market, so that in the future other patients can receive the suture material for skin closure.


Eligibility Criteria:
Inclusion:

* Written informed consent is available
* Patients undergoing skin closure with Dafilon®
* Small linear minimally contaminated incision/laceration in the trunk or extremities

Exclusion:

* Emergency surgery
* Pregnancy
* Facial lacerations or incisions
* Visible dirt in the wounds
* Nonlinear shape
* Patient taking medication that might affect wound healing
* Patient with hypersensitivity or allergy to the suture material
Nutritional Orientations and Adherence, Nutritional Status, Clinical and Life Quality Parameters of Heart Failure (HF) Patients

The nutritional systematic orientations in outpatients with heart failure throughout 1 year in comparison to conventional treatment is estimated to lead to higher nutritional treatment adherence and improved nutritional status, clinical and life quality parameters.

To evaluate the impact of systematic nutritional orientation on adherence to diet and relation to clinical, life quality and nutritional knowledge parameters in heart failure outpatients.

* To evaluate the impact of systematic nutritional orientation on nutritional status;
* To evaluate the impact of nutritional systematic orientation on dietary patterns
* To evaluate the impact of systematic nutritional orientation on clinical and biochemical parameters
* To evaluate the impact of nutritional systematic orientation on life quality
* To evaluate the impact of nutritional systematic orientation on nutritional knowledge

Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years old
* Outpatients from the HF Ambulatory (HCPA)
* Functional class I and II (NYHA)

Exclusion Criteria:

* Outpatient who had received any orientation from a nutritionist in the last 6 months
* Outpatients which has not received nursing orientation in the ambulatory,
* Patients from other NYHA class
* Non alphabetized
First Local Anaesthesia Thoracoscopy for Pleural Effusion Diagnosis.

Non randomized study with two groups. The study group includes patients with suspected malignant pleural effusion, in whom the investigation of pleural effusion begins directly with pleural biopsy by Local Anesthesia Thoracoscopy (LAT).

The Control Group includes patients who come to the same hospital and are treated with the Standard of Care (SOC) strategies were used. Efficacy of LAT, Sensitivity, Hospitalization, time to diagnosis and general safety and comfort of the groups' subjects will be assessed.

Diagnostic approach of patients with with unexplained lymphocytic exudate is the main subject of the study. Minimally invasive techniques (single entry thoracoscopy with local anesthesia -LAT) have been developed for the definitive biopsy of the parietal pleura, with which, in addition to the diagnosis, a therapeutic pleurodesis can be performed at the same time. Usually, diagnostic LAT is performed only after 3 negative pleural fluid cytological tests have been performed, thus delaying the diagnostic access and treatment of the patient.

The aim of this study is to evaluate the conventional diagnostic approach used in daily clinical practice (3 consecutive punctures of pleural effusion with cytological examination and in case of insufficient diagnosis pleural biopsy, either LAT or VATS depending on the clinical assessment of the patient) with the simplest immediate performance of LAT as soon as a pleural effusion suspected of malignancy is detected. Thus two subject groups will be compared. The first (LAT Group) will undergo Local Anesthesia Thoracoscopy as the first line option for the diagnosis of the suspected MPE. The control group will undergo the standard of care recommended guidelines for the diagnosis of MPE.

Eligibility Criteria:
Inclusion Criteria:

* Undiagnosed pleural effusion with the character of a lymphocytic exudate

Exclusion Criteria:

* Empyema
* Transudate pleural effusion.
* Central airway obstruction by tumor.
* Existence of extensive adhesions that do not allow the development of iatrogenic pneumothorax and the safe entry of the thoracoscope.
* Uncontrollable cough.
* Acute respiratory failure and/or Hypercapnia.
* Performance Status: 5
Safety and Tolerability of KH631 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

KH631 is a adeno-associated virus (AAV) vector-based gene therapy for subretinal injection. The long-term, stable therapeutic protein after one time injection for nAMD could potentially reduce the treatment burden and maintain vision.


Eligibility Criteria:
Inclusion Criteria:

* 1.Are willing and able to sign the study written informed consent form (ICF); 2. Men and women ≥ 50 and ≤85 years of age, diagnosed with nAMD at the Screening visit; 3. Subjects must be under active anti-VEGF treatment for nAMD and received a minimum of 3 injections within 6 months prior to screening; 4. Response to anti-VEGF therapy(Response is defined as reduction in CRT≥50μm or at least 30% reduction in fluid by OCT compared to disease at the worst); 5. BCVA between ≤20/63 and ≥20/400(≤63 and ≥19 Early Treatment Diabetic Retinopathy Study \[ETDRS\] letters) for the first patient in each cohort followed by BCVA between ≤20/40 and ≥20/400(≤73 and ≥19 ETDRS letters) for the rest of the cohort; 6. Must be pseudophakic(at least 3 months after intraocular lens implantation) in the study eye; 7.Female subjects must have been postmenopausal for at least 1 year.

Exclusion Criteria:

* 1.Any other cause of CNV, including pathologic myopia, etc, or other diseases except nAMD have an influence on the test of macular or affect the central visual acuity; 2.Presence of an implant, refractive media opacity affects fundus examination or narrow pupil of the study eye; 3.Active or history of retinal detachment in the study eye; 4.Uncontrolled glaucoma or ocular hypertension; 5.Have taken the drug known to have retinal toxicity; 6.History of intraocular surgery; 7.Uncontrolled hypertension despite medication at the screening visit.
Effects of MK7418 on Diuresis and Renal Function in Congestive Heart Failure Patients

A study to determine the most appropriate dose of MK7418 in heart failure patients presenting with symptoms of volume overload requiring increased diuretic doses.


Eligibility Criteria:
Inclusion Criteria:

* Be able to provide written informed consent,
* Be a male or female at least 18 years of age,
* Be hospitalized for fluid overload requiring IV diuretic therapy
* History of use of diuretic therapy for CHF (including this admission),
* Be admitted to the hospital within 36 hours of the mandatory dose of IV furosemide 40 mg at between 2000 and 2200 hour on Day -1

Exclusion Criteria:

* Have had a myocardial infarction within 30 days prior to Day -1
* Be pregnant or breast-feeding
* Have received intravascular contrast material within the preceding 14 days; or have acute contrast nephropathy
* Have had implantation of an automated implanted cardiac defibrillator (AICD) or synchronization device within the preceding 7 days
* Currently require mechanical ventilation, ultrafiltration, or hemodialysis,
* Have symptomatic ventricular tachycardia
* Be admitted for heart transplant surgery or have had a heart transplant,
* Have any other concomitant life-threatening disease,
* Have participated in a clinical trial of an investigational drug or device within 30 days before randomization
* Have a positive urine pregnancy test (for women of child-bearing capacity)
* Have an allergy to soybean oil and/or eggs
Caring Leadership Intervention Program for First-Line Nurse Managers

Caring leadership can help first-line nurse managers create a healthy environment, resulting in a positive outcome for nurse staff, patients, and healthcare organizations.

Developing caring behaviors among nurse managers is critical for establishing an effective nursing care environment. Enhancing the caring leadership of nurse managers would lead to improving nurses' perception regarding nurse manager caring behaviors and positive nurse outcomes. This study aimed to Examine the effect of a caring leadership intervention program for first-line nurse managers on their caring knowledge and managerial actions as well as nurses' perceived first-line nurse managers' nurse outcomes..

Eligibility Criteria:
Inclusion Criteria:

First nurse managers

* Work in inpatient wards and intensive care units
* Sign the informed consent

Exclusion Criteria:

First nurse managers

* Refuse to provide consent
* Decline to participate in the study
Effects of High Intensity Interval Training (HIIT) vs. Inspiratory Muscle Training on the Recovery After a Maximal Apnea.

The aim of this randomized cross-over controlled study was to assess the effects of an 4-week exercise program on the recovery capacity after a voluntary maximal apnea. Participants will be randomly allocated to receive either a high intensity interval training (HIIT), or an inspiratory muscle training (IMT) using an inspiratory resistance device.

It is a multi-center study. 3 different Spanish Freedivers Centres are included in the study (Madrid, Zaragoza, and Barcelona).

For each participant, exercise program started with one or the other program. Hence, both interventions were applied once with the participant randomly allocated to receive the same intervention. The trial included four study visits. Each exercise training program will be applied sessions per week during 4 weeks. Participants received baseline assessments at the beginning of nay intervention, and post-intervention assessments at the end of the fourth week. The wash-out period will be two weeks. After these two weeks participants switched intervention.

Eligibility Criteria:
Inclusion Criteria:

* Absence of pain or illness
* No changes in cognitive ability
* Over 18 years old.
* Member of the Spanish Federation of Underwater Activities.
* Positive medical examination that allows the diver to practice voluntary apnea.

Exclusion Criteria:

* People with systemic diseases, tumors, infections, pacemakers, history of epilepsy, hydrophobia, pregnancy women, pharmacological treatment.
* To be participating in other physical activities during the experimental research
A Study to Assess the Feasibility of Non-invasive Dried Blood Sampling

This is a Phase I, open-label, single-dose, 1-period study to compare EDG-5506 concentrations measured from venous and capillary blood sampling in healthy adult subjects.

EDG-5506 is an investigational product designed to selectively modulate a fast skeletal muscle motor protein called myosin that is part of the contraction machinery of the damage-prone muscle fibers.

Ten (10) healthy, adult male and female (of non-childbearing potential only) participants will be enrolled in the single-site study. Participants will receive a single oral dose of EDG-5506 on Day 1. Serial blood sampling will be collected pre-dose and up to 26 hours post-dose using venous blood sampling by venipuncture and capillary blood sampling by a capillary blood self-sampling device. On Day 3, participants will self-collect a capillary blood sample at home. The final on-site visit will be on Day 7 when a last blood sample will be collected using venous blood sampling by venipuncture and capillary blood sampling by a capillary blood self-sampling device.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy, adult, males or females, aged 19-55 years (inclusive) at the Screening visit.
2. Females must be of non-childbearing potential. Males with female partners must use a medically accepted contraceptive regimen or abstain from sexual intercourse for 90 days after dosing.
3. Non-smoker and must not have used any tobacco products within 3 months prior to the Screening visit.
4. Body weight greater than 50 kg and body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive at the Screening visit.
5. Medically healthy with no clinically significant findings for oculofacial and proximal limb strength assessments and swallowing function assessment, medical history, physical examination, laboratory profiles, vital signs, and ECGs.

Exclusion Criteria:

1. History of, or physical examination findings indicating clinically significant endocrine, neurological, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases that, in the opinion of the PI, would render the subject being unsuitable for the study.
2. Female participants with a positive pregnancy test at the screening visit or are lactating.
3. Poor venous access and/or cannot tolerate venipuncture.
4. Unable to refrain from or anticipates the use of any drugs (including prescription and non-prescription medications, herbal remedies, vitamin supplements, or grapefruit/Seville orange containing products) beginning 14 days prior to dosing. Any drugs known to be moderate or strong inducers of CYP3A4 enzymes cannot be used within 28 days prior to dosing.
5. Participation in any other investigational drug study within 30 days prior to dosing.
The Effect of Relaxing Breathing Exercise Applied to Patients Before Bone Marrow Biopsy on Vital Signs, Pain and Anxiety Levels

There is no study in the literature that determined the effect of relaxing breathing exercise applied to patients before the BMB procedure on vital signs, pain and anxiety levels.

The aim of this study is to determine the effect of relaxing breathing exercise applied to patients before bone marrow biopsy on vital signs, pain and anxiety levels.

hypotheses H1. Relaxing breathing exercise applied to the patients before the bone marrow biopsy procedure reduces the anxiety level of the patients compared to the control group.

H2. Relaxing breathing exercise applied to the patients before the bone marrow biopsy procedure reduces the pain level of the patients compared to the control group.

H3. Relaxing breathing exercise applied to the patients before the bone marrow biopsy procedure is effective on the respiratory rate of the patients compared to the control group.

H4. Relaxing breathing exercise applied to the patients before the bone marrow biopsy procedure is effective on the pulse rate of the patients compared to the control group.

H5. Relaxing breathing exercise applied to the patients before the bone marrow biopsy procedure is effective on the blood pressure of the patients compared to the control group.


Eligibility Criteria:
* Being between the ages of 18-65
* The fact that a bone marrow biopsy will be performed for the first time
* Absence of sedative, anxiolytic drug use
* Absence of a situation that would hinder communication.
Study of Acthar® Gel (Acthar) for Amyotrophic Lateral Sclerosis (ALS)

About 213 people with ALS will participate in this study. There will be locations in North and South America.

During the first part, participants will be randomly assigned to a group (like by flipping a coin). Out of every 3:

* 2 will get the study drug
* 1 will get a look-alike with no drug in it (placebo)

During the second part, everyone will get the study drug.

Participation will help doctors find out if Acthar can help or slow down the symptoms of ALS better than placebo.

This is a multicenter, multiple dose study to examine the effect of Acthar on functional decline in adult participants with ALS. Approximately 213 participants will be enrolled.

Following a screening period of up to 28 days, participants with ALS and symptom onset (defined as first muscle weakness or dysarthria) ≤ 2 years prior to the Screening Visit will be randomized on a 2:1 basis to receive subcutaneous (SC) Acthar 0.2 mL (16 Units \[U\]) daily (QD) or SC matching placebo 0.2 mL QD for 36 weeks, followed by a 3-week taper.

Participants who complete the 36 week double-blind treatment period are eligible to enter an Open Label Extension phase in which all participants will receive Acthar 0.2 mL (16 U) daily.

Eligibility Criteria:
Inclusion Criteria:

1. Is 18-75 years of age at Screening
2. Has ALS symptom onset within 2 years prior to Screening
3. Has forced vital capacity (FVC) no higher than 60% at screening
4. If taking riluzole, is on a stable dose for 4 weeks before Screening

Exclusion Criteria:

1. Has tracheostomy, diaphragm pacing, or an ongoing need for assisted ventilation of any type
2. Has used any medication within a time period not allowed per protocol
3. Has history of Type 1 or Type 2 diabetes mellitus, or any clinically significant infection
4. Used edaravone less than 1 week before Screening
5. Received any stem cell replacement therapy
6. Used steroids within a time period not allowed per protocol