cyrilzakka/clinical-trials huggingface dataset:
Lynparza Ovarian Cancer Clinical Experience Investigation (All Case Investigation)

\[Objectives\] Objectives include following to capture safety and efficacy of LYNPARZA in actual clinical use.

1. ADR development in actual clinical use
2. Factors which may affect safety and efficacy
3. ADRs not expected from "Precautions for Use"

The objective of the Clinical Experience Investigation (CEI) is to collect following data to characterise safety and efficacy of LYMPARZA Tablets 100mg and 150mg (LYMPARZA) in usual post-marketing use.

1. Development of adverse drug reactions (ADRs)
2. Factors which may affect safety and efficacy of LYMPARZA
3. Development of adverse drug reactions (ADRs) unexpected from "Precautions for Use" of the LYMPARZA JPI

Eligibility Criteria:
Inclusion Criteria:

* Maintenance treatment for patients with recurrent ovarian cancer, who are sensitive to platinum based chemotherapy

Exclusion Criteria:

-
Adjusting the Dose of Therapeutic Exercise to Prevent Neurotoxicity Due to Anticancer Treatment (ATENTO)

The purpose of this study is to determine whether a multimodal program based on therapeutic exercise and vagal activation techniques for newly diagnosed breast cancer women has better results in terms of neurotoxicity prevenion before or during medical treatments.

One of the most common side effects of breast cancer and its treatments is neurotoxicity of central and peripheral nervous system. Neurotoxicity is present in up to 75% of this population, which implies a large impact in quality of life. There is a special interest in the preventive possibilities of therapeutic exercise relating to these neurological sequelae, whose benefits could improve thanks to the combination with vagal activation techniques.

This superiority randomized controlled trial will be aimed to check the effects of a multimodal intervention (ATENTO) based on moderate-high intensity and individualized therapeutic exercise (aerobic and strength exercises) and vagal activation techniques (myofascial stretching and breathing exercises), on neurotoxicity prevention in women with breast cancer before starting potentially neurotoxic treatments (ATENTO-B) versus throughout them (ATENTO-T). A sample of 56 women newly diagnosed with breast cancer calculated with a power of 85% will be allocated into two groups.

This study could provide an impetus for the introduction of early multimodal intervention methods of preventing neurotoxicity and consequently avoid the current QoL deterioration that breast cancer patients suffer throughout their treatments.

Eligibility Criteria:
Inclusion Criteria:

* To have 18 years or older
* To have a breast cancer diagnosis (Stage I-III)
* To be on waiting list for medical adjuvant treatment with risk of central and/or peripheral neurotoxicity.
* To have signed the informed consent.
* To have medical clearance for participation.

Exclusion Criteria:

* To have a previous history of cancer or any cancer treatment.
* Pregnant patients.
* To participate in another intervention that could influence on the outcomes.
* To have a neurodegenerative disease that affects central or peripheral nervous system and could influence the results.
China Survey of Peptic Ulcer Bleeding

This will be a multicenter prospective observational study carried out in China. The investigators will collect data in a pre-specified Case Report Form. Main data from each patient will include demographics, endoscopy classification, and both endoscopy and pharmacological treatments received by patients. Data from each patient will be prospectively collected from the day the patient is diagnosed as peptic ulcer bleeding by endoscopy and receives endoscopy treatment if the investigator thinks it is needed and up to 30 days afterwards. The proportion of peptic ulcer bleeding patients who are at high risk is the primary outcome variable. High risk is defined as the patients with endoscopy Forrest classification Ia to IIb. The rate and type of endoscopic treatment, the rate of successful endoscopy treatment, the re-bleeding rate and the endoscopic re-treatment rate in high risk peptic ulcer bleeding patients will be collected. The surgery rate and mortality rate in high risk and overall patient population will be calculated.


Eligibility Criteria:
Inclusion Criteria:

* Female and/or male aged 18 years and above
* Admitted to the hospital with an overt upper GI bleeding (hematemesis/coffee ground vomiting, melena, hematochezia and other clinical or laboratory evidence of acute blood loss from the upper GI tract)
* Endoscopy demonstrated peptic ulcer bleeding (Forrest I-III)

Exclusion Criteria:

* If participating in any clinical trial, the subject cannot take part in this study.
Laser Therapy on TMJ Disorders After Head and Neck Cancer.

Temporomandibular disorder (TMD) is a term describing musculoskeletal conditions of the face, jaw and temporal regions. TMD is frequently associated with pain and/or dysfunction such as impaired jaw function, pain in the temporomandibular joint (TMJ), muscles and/or related structures, and associated headaches. The aetiology of TMD is multifactorial and complex.

It is known that one cause of TMD symptom development is treatment for head and neck cancer (HNC). The main treatment modalities for HNC include radiotherapy (RT) with or without chemotherapy and surgical intervention, either as a single therapy or a combination therapy. In the head and neck region, the anatomical structures are necessary for essential functions such as speech, swallowing, breathing, smell, and taste. The treatment of head and neck tumours may frequently impair some of these functions, which may result in pain, oral dysfunction, and impaired health-related quality of life.

High intensity laser therapy (HILT) is a non-invasive and painless treatment method. The latest studies have reported the beneficial effects of neodymium-doped yttrium aluminum garnet (Nd: YAG) laser therapy in patients with pain. The advantage of HILT over low level laser therapy (LLLT) is that HILT is able to penetrate and stimulate wider and/or deeper areas; thus, considerably more energy may be transmitted to tissue during HILT therapy compared to LLLT.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with temporomandibular joint disorders (myofascial pain, trismus and limitation of ROM) after head and neck cancer, patients will be diagnosed by an experienced oral and maxillofacial surgeon.
2. Patients with 20 to 60 years old.
3. 6 months after ending radiotherapy.

Exclusion Criteria:

1. Patients with implants.
2. Current metastasis.
3. Continuing radiotherapy.
4. Pregnant females.
5. Sensitivity to phototherapy.
6. Bells palsy.
7. Subjects with disk displacement, arthralgia or osteoarthritis at TMJ.
8. Subjects who received analgesics or antidepressants.
The Effect of Experimentally Increasing Sedentary Behaviour on Subjective Well-being

This study will explore the causality between outcomes of subjective well-being and sedentary behavior, through experimentally increasing the sedentary behavior levels of active university students. Half of the eligible participants will receive a behavioral counseling intervention to increase sedentary behavior over one week, while the other half will receive no instructions. After one week, all participants will receive no instructions and continue to wear the inclinometer for another week.

The relationship between subjective well-being (SWB) and sedentary behavior (SB) has been briefly explored. However, the causality of the relationship (i.e., do higher levels of SB cause changes in SWB, or vice-versa) has not been fully examined. Experimentally increasing SB and observing the potential subsequent effect on SWB, in otherwise non-sedentary individuals, may help to determine the causation between SB and SWB.

An active sample of full-time university students attending Western University will be recruited. Upon obtaining consent, demographics will be taken. Baseline sedentary behavior levels will be confirmed objectively through inclinometer wear for 1-week. Upon confirmation of sufficient sedentary/non-sedentary time, participants will complete questionnaires assessing past-week: SWB, SB, physical activity, depression, and anxiety questionnaires. Participants will also be randomized to either a behavioral counseling intervention group, or a no-contact control group. Participants will then continue wearing the inclinometer for 1 week. After the intervention week, participants will complete the questionnaires again, after which all participants will be told to continue daily behavior, and wear the inclinometer for another week. Upon completion of this follow-up week, participants will complete questionnaires again.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Full-time student attending Western University
* Able to read and write in English
* Self-reporting ≥150 minutes/week of moderate-vigorous physical activity

Exclusion Criteria:

* Self-reporting a mental illness
* Currently having a physical disability that would prevent walking
Study of MK-0476 in Adult Patients With Acute Asthma (0476-334)

The study estimates the efficacy and safety of MK0476 and aminophylline intravenous administration in adult participants with acute asthma.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants with acute asthma attacks

Exclusion Criteria:

* Participant has any known or suspected, acute or chronic cause for their pulmonary symptoms other than asthma (e.g., COPD, chronic heart failure, etc.).
* Participant has a smoking habit (15 cigarettes per day) within a month prior to screening period, and/or has a smoking history (20 cigarettes per day) of more than 15 years.
* Participant has a disease of the cardiovascular, hepatic, renal, hematologic systems, or other severe disease.
Effect on Acetaminophen Metabolism by Liquid Formulations

The purpose of this study is to determine whether excipients in the liquid formulation of acetaminophen prevent the formation of the toxic metabolites of acetaminophen.

Acetaminophen (APAP) poisoning is the most frequent cause of acute hepatic failure in the United States. Toxicity requires cytochrome P-450 bioactivation of APAP. Children are less susceptible to APAP toxicity; the current theory is that they have different metabolism than adults. However, children's liquid preparations of APAP contain excipients which have been shown to inhibit APAP bioactivation in vitro and in rodents. Children tend to ingest liquid preparations, which could potentially explain their decreased susceptibility instead of an intrinsically different metabolism. Further, our review of Poison Center epidemiologic data shows that liquid preparations are less toxic in adults. Our hypothesis is that excipients in liquid preparations inhibit the bioactivation of APAP. The design is a pharmacokinetic cross-over study in humans. Healthy adult subjects will be recruited for administration of therapeutic doses of APAP in capsule and liquid formulations. Plasma via a heplock will be collected at serial time points up to 8 hours and assayed for APAP and its metabolites. After a washout period, subjects will receive the same dose of APAP in the alternate preparation. The pattern of metabolites, indicating the activity of the bioactivating enzymes, will be compared. A significant difference in P-450 metabolites will support the hypothesis and provide preliminary data for studies in patients who have ingested potentially toxic doses of APAP. Ultimately, this work could support development of novel antidotal therapy for APAP overdose.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer ages 18-40
* Not taking any chronic medications

Exclusion Criteria:

* Pregnancy
* Any history of liver disease
* Frequent alcohol use (2 or more drinks more than 4 times per week)
* Unable to provide informed consent
High Intensity Cycling Before SCUBA Diving Reduces Post-decompression Microparticle Production and Neutrophil Activation

The purpose of this study is to determine the impact of high intensity,anaerobic exercise, in the form of cycling, on SCUBA diving. Outcomes are determined by the quantification and subtype of circulating microparticles, complete blood counts, and the quantification of venous gas emboli, measured via transthoracic echocardiography, in the cardiac cavities.


Eligibility Criteria:
Inclusion Criteria:

* Experienced divers (\> 250 logged dives)
* Male
* Physician clearance to dive

Exclusion Criteria:

* Prior incidence of decompression sickness
Augmented Effects of Virtual-reality Cycling Training on Upper Limb Motor Functions by NIBS in Patients With CP

Cerebral palsy (CP) is the most common childhood motor disability. Weakness, spasticity, and loss of dexterity are the major problems in patients with CP. A novel virtual-reality cycling training (VCT) program was to enhance promising muscle strength and motor function through promoting the participant compliance and motivation. Non-invasive brain stimulation (NIBS), such as repetitive transcranial magnetic stimulation (rTMS) and transcranial electric stimulation (TES) has potential to augment the training effects in motor neurorehabilitation via the modulation on neuroplasticity. Therefore, this study propose a novel intervention protocol to induce superior benefits on upper extremity (UE) motor function in patients with CP.

This study aims to investigate the augmented effects of VCT on neuromotor control and UE motor function by NIBS in patients with CP. We hypothesize that NIBS can augment the VCT effects on neuromotor control and UE motor function in patients with CP because combined therapy integrated peripheral modification techniques (VCT) and central modulation (NIBS). These effects may further enhance the activity of daily living (ADL), participation, and health related quality of life (HRQOL). This project is executed in the following two phases: to investigate the augmented effects of VCT on neuromotor control and UE motor function in patients with CP by rTMS in phase 1 (0-1.5 years) and tCS in phase 2 (1.5-3 years).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CP according to clinical criteria
* Age 5-20 years
* No use of botulinum toxin in the past 4 months
* No significant perceptual or communication disturbances
* No other peripheral or central nervous system dysfunction
* No active inflammatory or pathologic changes in upper limb joints during the previous 6 months
* No active medical problems, such as pneumonia, upper gastrointestinal bleeding, or urinary tract infection
* No active problems of epilepsy and EEG without epileptiform discharge

Exclusion Criteria:

* Metabolic disorders, such as inborn error of metabolism, electrolyte, and endocrine disorders
* Active infectious disease, such as meningitis and encephalitis
* Patients with active medical problems, such as pneumonia, upper gastrointestinal bleeding, or urinary tract infection
* Poor compliance or intolerance for the TMS therapy
* Subjects with metallic implants or pregnancy.
* EEG show epileptiform discharge
* Patients with family history of epilipsy
* Patients with symptoms that are restricted from tDCS, such as epilepsy, migraine and unstable health condition
Balance Targeted Exercises for Individuals With MS

The purpose of this study is to examine the effects of a postural adjustment, targeted training program on balance ability and postural responses anticipatory postural adjustments (APA) and compensatory postural adjustments (CPA) in individuals with MS

All participants participated in individual training program aimed at improving balance ability and postural adjustments. The training program and individual activities were based on previously published programs and motor learning principles, and consists of 18, 1-hour training sessions over six weeks (3 sessions/week). Training occurred in person 2 days a week (in person training) and at home (home exercise program) 1 day a week, for a total of 3 sessions per week. The duration of training sessions were 60 minutes per session for a total of 1,140 minutes of training. The exercise room temperature was centrally regulated (23.3 degrees C).

Eligibility Criteria:
Inclusion Criteria:

1. Must be18 to 70 years of age.
2. Medical diagnosis of MS confirmed by a neurologist.
3. Ability to stand independently without any aid for at least 3 minutes.
4. A Patients determined disease steps (PDDS) score of 5 or lower.
5. Normal or corrected-to-normal vision.
6. English or Spanish speaking.

Exclusion Criteria:

1. MS-related exacerbation or medication change in the past two months.
2. Presence of concurrent neurological or orthopedic disorders.
3. Unable to perform the experimental tasks.
A Study of LY2605541 and Insulin Lispro Mixture in Healthy Participants

The main purpose of this study is to evaluate how the body absorbs and removes LY2605541, insulin lispro, and a mixture of both from the blood. The study has two parts. Participants may enroll in only one part. Each part has four treatment periods in a fixed order. The study will last approximately 8 weeks, not including screening. Screening is required within 28 days prior to the start of the study.


Eligibility Criteria:
Inclusion Criteria:

* Are not of child-bearing potential
* Have a body mass index (BMI) between 18 and 29.9 kilograms per meter squared (kg/m\^2), inclusive
* Are nonsmokers or have not smoked for at least 2 months prior to entering the study

Exclusion Criteria:

* Have known allergies to insulin or its excipients, or related drugs, or history of relevant allergic reactions of any origin
* Have a history of first-degree relatives known to have diabetes mellitus
* Have used systemic glucocorticoids within 3 months prior to entry into the study
* Have donated blood or had a blood loss of 450 milliliter (mL) within 1 month prior to study enrollment
Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer

This clinical trial studies fluorine F-18 sodium fluoride positron emission tomography (PET)/computed tomography (CT) in diagnosing bone tumors in patients with cancer. Diagnostic procedures, such as fluorine F-18 sodium fluoride PET/CT, may help find and diagnose bone cancer

The objective of the study is to use 18F sodium fluoride (fluorine F-18 sodium fluoride) PET/CT scanning to detect and characterize lesions in patients who have suspected skeletal malignancy. We hypothesize that scanning with 18F-NaF (fluorine F-18 sodium fluoride) is more sensitive for skeletal abnormalities and may better characterize lesions than conventional imaging.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for evaluation of suspected skeletal cancer
* Patients must understand and voluntarily sign an informed consent form after the contents have been fully explained to them

Exclusion Criteria:

* Patients who cannot complete a PET/CT scan
* Pregnant women
* Healthy volunteers
Atherosclerosis in Familial Hypercholesterolemia

Familial hypercholesterolemia (FH) is a common inherited disorder with a frequency of 1 in 500 in the UK. Our aim is compare the carotid and coronary artery atherosclerosis in monogenic FH and polygenic hypercholesterolemia with means of a carotid ultrasound, a coronary CT angiogram and biochemical biomarkers.

Familial hypercholesterolemia (FH) is a common inherited disorder with a frequency of 1 in 500 in the UK. Previous Studies showed that risk of heart attack in these patients is at least 50% higher in men and 30% higher in women compared to the general population as they have high blood cholesterol since birth. We propose to develop a screening model based on non-invasive visualisation of the heart blood vessels (coronary arteries) by CT scan, ultrasound of the neck vessels (carotid arteries) and blood tests to access the extend of cholesterol deposit in the blood vessels in these patients. Participants with confirmed diagnosis of FH would be recruited from FH database registry at Royal Free Hospital. They would have a CT coronary angiogram, an ultrasound of carotid arteries and a blood test. The study is divided into overlapping stages of recruitment and data collection and data analysis. If CT scan shows more than 70% obstruction in their coronary arteries, they would be offered a coronary angiogram and an intracoronary Optical Coherence Tomography for assessment of their blood vessel blockage.

Eligibility Criteria:
Inclusion Criteria:

* The subjects must give written informed consent to participate in the study, Male and female subjects ≥ 18 years old, documentation of clinical diagnosis of familial Hypercholesterolemia

Exclusion Criteria:

* Estimated GFR \<45, pregnant women, Atrial fibrillation or unstable heart rate, Established ischemic heart disease, previous Percutaneous Coronary Investigations (PCI) or Coronary Artery Bypass Surgery (CABG), Known allergy to iodine contrast
First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors

This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.

DS-3939a is an antibody drug conjugate (ADC) being developed for the treatment of malignant tumors. This is a first-in-human, dose-escalating clinical study divided into 2 parts: the Dose Escalation Part (Part 1) and the Dose Expansion Part (Part 2).

Eligibility Criteria:
Inclusion Criteria:

* Sign and date the main Informed Consent Form (ICF).
* Has a left ventricular ejection fraction ≥50% by either an echocardiogram or multigated acquisition within 28 days of enrollment.
* Has adequate organ function.
* Measurable disease based on RECIST V1.1.
* Eastern Cooperative Oncology Group performance status score of 0 or 1.

Additional inclusion criteria for Part 1

* Has a histologically or cytologically documented locally advanced, metastatic, or unresectable solid malignant tumors.

Additional inclusion criteria for Part 2

* Has a histologically or cytologically documented locally advanced, metastatic, or unresectable cancer meeting the protocol criteria and documented radiographic disease progression during or after the most recent anticancer therapy.
* Is able to provide either of the following baseline tumor samples:

  * Fresh tumor biopsy samples meeting either of the following requirements that were obtained during the Main Screening or Tissue Screening Period, or
  * Fresh core needle biopsy sample
  * Biopsy samples obtained with forceps or cryobiopsy, such as bronchoscopic or transbronchial lung biopsy (if the sample amount is equivalent to core needle biopsy and processing after sample collection follows the procedure described in the Study Laboratory Manual)
  * FFPE tumor tissue samples obtained by biopsy or surgery performed after the completion date of the most recent anticancer therapy regimen and within 6 months before signing the ICF

Exclusion Criteria:

* Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC1.
* Has spinal cord compression or history of/clinically active central nervous system metastases.
* Has multiple primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years.
* Has a history of noninfectious interstitial lung disease (ILD)/pneumonitis (including suspected one), has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
* Has active or uncontrolled human immunodeficiency virus (HIV) infection.
* Has evidence of active or uncontrolled hepatitis B virus or hepatitis C virus infection.
* Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
* Has an active, known, or suspected autoimmune disease.
* Current participation in other therapeutic investigational procedures, except for participation in Long Term Follow-Up without any investigational treatment.