cyrilzakka/clinical-trials huggingface dataset:
Special Use-Result Surveillance of Unasyn-S (Kit) for Intravenous Use - A Surveillance on High-dose (>6 g Daily) Administration -

The purpose of the survey is to study the followings under practical use, regarding the safety and effectiveness in high-dose administration (exceeding 6 g per day) of UNASYN-S and UNASYN-S KIT for intravenous use (UNASYN).

1. Adverse Drug Reaction(s) that cannot be expected from precautions (Unexpected Adverse Drug Reaction)
2. Incidence status of adverse drug reactions
3. Factors that may affect the safety and effectiveness

Implemented as a Special Investigation by a central registration system. Secondary data collection. Safety and effectiveness of UNASYN-S under Japanese medical practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the following disease who received high doses of UNASYN (exceeding 6 g per day) from the first dosing date or the second dosing date. 1) Pneumonia, 2) Lung Abscess, 3) Peritonitis
* Patients aged 15 years or more

Exclusion Criteria:

* Patients with the following disease who received high doses of UNASYN (less than 6 g per day) from the first dosing date or the second dosing date. 1) Pneumonia, 2) Lung Abscess, 3) Peritonitis
* Patients aged less than 15 years.
Iressa vs Placebo as Maintenance Therapy in Locally Advanced NSCLC

The aim of the study if to determine if Iressa can prolong the period of time without any disease worsening (Time to progression) in patients previously treated with combined therapy such as surgery and chemotherapy with or without radiotherapy or chemotherapy and radiotherapy


Eligibility Criteria:
Inclusion Criteria:

* Histologically Confirmed Non Small Cell Lung Cancer.
* Locally advanced disease previously treated with combined therapy (chemotherapy and surgery with or without radiotherapy, or chemotherapy and radiotherapy).
* Chemotherapy with regimens containing cisplatin or carboplatin is mandatory
* Response to combined therapy

Exclusion Criteria:

* No previous treatment with ZD1839 or any other EGFR-targeted therapy
* No progressive disease after combined therapy for locally advanced NSCLC
* No presence of metastatic disease
* No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
* Any unresolved chronic toxicity from previous anticancer therapy.
The Effect of Lower Body Positive Pressure Treadmill Training on Individuals With Chronic Stroke

Stroke is neurological disease characterized by chronic major disability which will cause permanent changes in individuals life. In Saudi Arabia stroke considered as the main leading of disability and death. It is estimated to be 0.67% in Saudi Arabia compared to 2.5% of the population in the United States (US). Most of individuals have mobility deficit such as walk speed and postural maintenance which lead to increase the risk of fall and decrease activity of daily living (ADL).

Stroke rehabilitation should starts as early as possible to avoid post-stroke complications. Several interventions for stroke rehabilitation to improve mobility deficit and posture control continuously being evaluated. One of the ways of stroke rehabilitation is a using of body weight supported treadmill training (BWSTT). It is a useful tool to facilitate gait training and recovery after neurological injures.

The lower body positive pressure (LBPP) is a treadmill that is enclosed in inflated bag. There is a chamber inside the treadmill that is produce air pressure which is aid in eliminate the uncomfortableness feeling produce by weight bearing during gait. The chamber is supplied with a system provide LBPP aiding in decrease patient weight while walking by giving the patient lifting force from below using air pressure. This helps the patient to walk affectively with minimum weight bearing on the lower extremity.

Therefore, the purpose of the study is to evaluate the feasibility and effectiveness of LBPP on gait function, balance and quality of life in chronic stroke individuals.

The investigators hypothesis that the LBPP will significantly improve gait function, balance, quality of life in chronic stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* Hemiparesis due to stroke; at least 6 months since the stroke.
* Independent ambulatory ability with or without assistive device at least 10 meters.
* Do not have any additional neurological and/or orthopedic deficiencies impairing ambulation.
* Functional ambulation ≥ 3 on functional ambulation categories
* No history of cardiac, respiratory, cardiovascular conditions interferes with protocol,
* Able to understand simple instructions,
* Able to control the head and trunk posture.

Exclusion Criteria:

* recurrent stroke,
* spasticity greater than 3 on modified Ashowrth scale,
* Ataxia, or tremor of lower limb
A Registered Cohort Study on Neurodegenerative Associated With Sleep Disorder.

Cognitive impairment often appears in neurodegenerative diseases, and it is expected to further study the mechanism of sleep disorders associated with the progression of neurodegenerative diseases by exploring the clinical manifestations, imaging, and biological marker changes of sleep disorders in neurodegenerative diseases.


Eligibility Criteria:
Inclusion Criteria:

1. clinical diagnosis of neurodegenerative disease.
2. patients experience insomnia, excessive drowsiness, or confusion at night.
3. Patients experience frequent awakenings, daily sleep episodes, or nocturnal confusion.
4. The presence of one or more of the following characteristics: a. wandering at night with inappropriate activity; b. agitation, combativeness; c. confusion, disorientation, or marked delirium.
5. Polysomnographic monitoring showed the following two conditions: a. poor sleep efficiency, increased number and duration of awakenings; b. multiple sleep latency tests showed increased daytime sleepiness.
6. Presence of other medical symptoms that do not indicate the primary disease.
7. Other sleep disorders (e.g., periodic limb movement disorders, obstructive sleep apnea syndrome) may be present, but do not explain the patient 's main symptoms.
8. any of the above can be diagnosed

Exclusion Criteria:

1. Patients with other neurological disorders.
2. Pregnant or lactating women.
Effectiveness and Cost Impact of a Telecommunications System in COPD

Chronic obstructive pulmonary disease (COPD) is one of the most common chronic illnesses among veterans in the adult population, and accounts for substantial morbidity and mortality in this population. Interventions that enhance symptom self-monitoring and increase understanding of COPD therapy may lead to earlier detection of clinical deterioration permitting more timely intervention by health care providers. However, such interventions are labor-intensive and expensive, and typically require patients to go to a medical facility on a regular basis. A novel means of providing such interventions is a Telephone-Linked Computer (TLC) system, a computer-based telecommunications system that can monitor, educate, and counsel patients through regular automated conversations in patients� homes. In previous studies, we have demonstrated the applicability of TLC technology in the clinical monitoring of adults with chronic disease conditions such as hypertension and hypercholesterolemia.

Background:

Chronic obstructive pulmonary disease (COPD) is one of the most common chronic illnesses among veterans in the adult population, and accounts for substantial morbidity and mortality in this population. Interventions that enhance symptom self-monitoring and increase understanding of COPD therapy may lead to earlier detection of clinical deterioration permitting more timely intervention by health care providers. However, such interventions are labor-intensive and expensive, and typically require patients to go to a medical facility on a regular basis. A novel means of providing such interventions is a Telephone-Linked Computer (TLC) system, a computer-based telecommunications system that can monitor, educate, and counsel patients through regular automated conversations in patients� homes. In previous studies, we have demonstrated the applicability of TLC technology in the clinical monitoring of adults with chronic disease conditions such as hypertension and hypercholesterolemia.

Objectives:

The objectives of the study were to determine whether a telecommunications system for COPD care (TLC-COPD) leads to improvements in functional status and quality of life (QOL) as well as to reductions in health care utilization and costs exceeding the TLC intervention.

Methods:

The study was designed in the form of a randomized controlled trial involving subjects with COPD who receive care at two Boston-area VA hospitals. Subjects were assigned to either TLC-COPD or a usual care control group.

Status:

Complete.

Eligibility Criteria:
Inclusion Criteria:

COPD diagnosis; FEV, \< _65% pred; FEV, /FVC\<_85% pred

Exclusion Criteria:
Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.


Eligibility Criteria:
Key Inclusion Criteria:

* Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.
* Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression.
* Participant must have been taking oral antidepressants for at least 8 weeks and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study.
* Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).
* Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.

Key Exclusion Criteria:

* A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD.
* Are considered by the investigator to be at imminent risk of suicide or injury to self or others.
* Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode.
Effectiveness, Safety, and Health-Related Outcomes of NUEDEXTA® in Nursing Home Patients With Pseudobulbar Affect (PBA)

6 month study of NUEDEXTA ® (Dextromethorphan Hydrobromide and Quinidine Sulfate) for the treatment of Pseudobulbar Affect (PBA) in Nursing Home Patients.

Eligible patients for this study must have a diagnosis of a neurological disorder affecting the brain of at least 3 months duration prior to baseline and which is not rapidly progressing and must have a diagnosis of Pseudobulbar affect (PBA).

This is a multicenter, open label study consisting of 6 months of treatment.

Approximately 125 patients will be enrolled at approximately 25 centers in the United States.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a neurological disorder affecting the brain (e.g. Alzheimer's and other dementias, stroke, Trauma Brain Injury, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Huntington's disease, Parkinson's disease) of at least 3 months duration prior to baseline and which is not rapidly progressing
* Diagnosis of Pseudobulbar Affect (PBA)
* A Center for Neurologic Study-Lability Scale (CNS-LS) score of 13 or greater at Baseline
* Minimum Data Set (MDS) information for patient available within 60 days prior to Baseline
* Informant who is willing to comply with study procedures

Exclusion Criteria:

* Patients who have received NUEDEXTA® in the past 1 year
* Patients with the diagnosis of Severe Depressive Disorder that would interfere with the conduct of the study
* Patients who have a history of schizophrenia spectrum and other psychotic disorders
* Patients with co-existent clinically significant or unstable systemic diseased that could confound the interpretation of the safety results of the study (e.g.,malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
* Patients with myasthenia gravis
The Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders

The high percentage of failure using available non-surgical options to treat menorrhagia in women with bleeding disorders shows a continuing need for innovative treatments. This has led to development of this protocol in order to make available tranexamic acid as a potentially effective menorrhagia therapy option in women with an underlying bleeding disorder. We anticipate that Tranexamic Acid may be a beneficial choice for controlling menorrhagia in bleeding disorder patients.

Women with heavy periods and with a diagnosed bleeding disorders are prescribed cyclokapron pills to be taken during their periods. Their periods are assessed at 3 and 6 months by filling out a pictorial blood assessment chart. If the drug appears to be working with no adverse effects the patients can continue to take the medication as long as it is available with follow up with the investigator every 6 months.

Eligibility Criteria:
Inclusion Criteria:

* all menstruating women regardless of age
* Women with heavy periods as measured by pictorial blood assessment chart
* Women diagnosed with a bleeding disorder

Exclusion Criteria:

* Acquired defective color vision
* Factor VIII, Factor IX, FactorXI levels \>250%
* An inherited thrombophilic defect detected because of a positive family or personal history of thrombosis
* Current use of oral contraceptives
Impact of One Versus Two Amino Acid Chelated Iron Capsules on Prevention of Iron Deficiency Anemia in Non-anemic Women With Twin Gestations

Anaemia is the most worldwide health problem affecting pregnant women in both developed and developing countries. During pregnancy there is an inconsistent increase in plasma volume and haemoglobin mass.

Iron deficiency anemia is the commonest type of anemia during pregnancy. The pregnant woman needs about 1000 mg of iron during pregnancy.

Diet alone cannot give pregnant woman the daily required amount of the iron (about 27 mg/day) so the Centers for Disease Control and Prevention recommend that pregnant women take a daily supplement of 30 mg of elemental iron as a preventive dose. As most women begin their pregnancy with low iron stores, particularly in the second and third trimesters, so prevention should start as soon as possible even before pregnancy to prevent depletion of iron store and further Iron deficiency anemia.

Oral iron is a cheap, effective and relatively safe line to prevent Iron deficiency anemia during pregnancy. The common available ferrous salts include ferrous fumarate, ferrous sulphate and ferrous gluconate. Unfortunately; these iron forms are associated usually with constipation, darkened stools, diarrhea, loss of appetite, nausea, stomach cramps, and vomiting.

Iron amino acid chelates have been emerged to be used as agents for prevention and treatment of Iron deficiency anemia. These agents provide maximum bioavailability and maximum efficacy with minimal unpleasant side effects.

Twin pregnancies have a significant role in perinatal morbidity due to increased risks of low birth weight and preterm birth. The iron requirement for twin pregnancy is probable double fold that of a singleton pregnancy and maternal hemoglobin in twin gestations is usually lower than in singleton pregnancy resulting in higher rate of Iron deficiency anemia.


Eligibility Criteria:
Inclusion Criteria:

* twin gestations
* ±12 weeks)
* normal hemoglobin level (Hb ≥ 120 g/L).
* women were living in nearby area to make up follow up quit possible
* willing to participate in our study

Exclusion Criteria:

* a recent blood transfusion
* threatened miscarriage
* pathological blood loss
* vegetarian diet
* intolerant to oral iron form
* history of haematologic disorder
* chronic diseases
* unwillingness to co-operate.
Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging

We propose a single-scan two-injection myocardial perfusion imaging protocol using ammonia. Subjects will undergo single-scan two-injection imaging as well as regular stress single-scan single-injection protocol and the myocardial blood flow of both techniques will be compared.


Eligibility Criteria:
Healthy Volunteers:

Inclusion Criteria:

* Subjects must be ≥30 and ≤75 years of age;
* Subjects must provide informed consent prior to study procedures;

Exclusion Criteria:

* History of CAD, including:
* Prior abnormal myocardial perfusion study
* History of MI
* History of angina
* Coronary artery obstruction \>50% on CTA and/or angiography
* Left ventricular ejection fraction \<50%
* Any relative or absolute contraindication to adenosine stress, including:
* 2nd or 3rd degree heart block
* Bradycardia (HR\<50 bpm)
* Recent acute coronary syndrome (ACS)
* Unstable angina
* Severe heart failure (left ventricular ejection fraction \<15%)
* Ventricular arrhythmia
* Severe asthma and/or chronic obstructive pulmonary disease (COPD)
* Baseline hypotension defined as systolic blood pressure \< 90 mmHg
* Caffeine intake within 24 hours prior to imaging
* Current use of theophylline, dipyridamole, or carbamazepine
* Allergy or intolerance to adenosine
* Positive serum and/or urine pregnancy test, or lactating, or possibility of pregnancy cannot be ruled out prior to dosing;

Subjects with CAD:

Inclusion criteria

* Subjects must be ≥30 and ≤75 years of age;
* Subjects must provide informed consent prior to study procedures;
* Abnormal myocardial perfusion study within the past 12 months

Exclusion criteria

* Revascularization (percutaneous coronary intervention and/or coronary artery bypass) following last myocardial perfusion study
* Acute coronary syndrome within 30 days
* Left ventricular ejection fraction \<50%
* Any relative or absolute contraindication to adenosine stress, including:
* 2nd or 3rd degree heart block
* Bradycardia (HR\<50 bpm)
* Recent acute coronary syndrome (ACS)
* Unstable angina
* Severe heart failure (left ventricular ejection fraction \<15%)
* Ventricular arrhythmia
* Severe asthma and/or chronic obstructive pulmonary disease (COPD)
* Baseline hypotension defined as systolic blood pressure \< 90 mmHg
* Caffeine intake within 24 hours prior to imaging
* Current use of theophylline, dipyridamole, or carbamazepine
* Allergy or intolerance to adenosine
* Any clinically significant acute or unstable physical or psychological disease, judged by the investigators, to be incompatible with the study;
* Radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);
* Female participants only: Positive serum and/or urine pregnancy test, or lactating, or possibility of pregnancy cannot be ruled out prior to dosing;
* Inability to provide written informed consent;
A Healthy Subject Study With Z-360 and Placebo

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (including food effect) of single and multiple doses of Z-360 in healthy Japanese subjects.

This is a single centre, randomized, double-blind, placebo-controlled, parallel-group, and food effect study.This is three parts study. The purpose of the first part (Part 1) is the evaluation of the safety, tolerability, and pharmacokinetics after single ascending doses of Z-360.The second part (Part 2 ) is the evaluation of the pharmacokinetics of food effect of Z-360.The third part (Part 3) is the evaluation of the safety, tolerability, and pharmacokinetics after multiple ascending doses of Z-360.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects between 20 to 49 years of age inclusive
2. Body mass index (BMI) within the range 17.6 to 26.4 kg/m2 inclusive
3. The subject is capable of giving written informed consent prior to admission into this study

Exclusion Criteria:

1. History or presence of drug hypersensitivity, drug dependence, narcotic dependence or alcohol dependence
2. History or presence disease of digestive, liver, kidney, blood, cardiovascular, neuropsychiatric which may affect participation or results of this study
3. Positive test for Hepatitis B surface antigen, Hepatitis C antibody, HIV antigen antibody or Serological test for syphilis
4. Use of any medication within 1 week prior to dosing
5. Received any investigational drugs with new active ingredients within 16 weeks prior to dosing the study or received any investigational drugs in other clinical studies within 12 weeks
6. Whole blood collection exceeding 200 mL within 4 weeks, apheresis within 2 weeks, or blood withdrawal exceeding 400 mL within 12 weeks (blood donation, etc) prior to dosing
7. Others, patients who are unfit for the study as determined by the attending physician
Sisomicin Cream Vs Nadifloxacin Cream in Primary Pyodermas (Study P04460)

This open-label, randomized, parallel-group clinical study is designed to compare the efficacy and safety of the topical antibiotic, sisomicin cream, with that of another topical antibiotic cream, nadifloxacin cream, in the treatment of Indian patients with primary pyodermas.


Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex and suffering from primary pyodermas requiring topical antibiotic therapy without occlusive dressings.
* \>=6 years of age.
* Written informed consent.

Exclusion Criteria:

* Patients must not take any other antibiotics.
* Patients should not be hypersensitive to any of the test drugs.
* Patients are not to have any other investigational drug within one month of starting this study.
* Patients cannot be enrolled more than once in the study.
* Patients must not have any significant medical condition which, in the judgment of the investigator, might interfere with the study or require treatment.
* Pregnant women and nursing mothers are to be excluded.