cyrilzakka/clinical-trials huggingface dataset:
A Study of RO5024048 in Japanese and Caucasian Healthy Volunteers

This randomized, double-blind, placebo-controlled study will assess the safety, tolerability and pharmacokinetics of RO5024048. Japanese and Caucasian healthy volunteers will be randomized to receive either single oral doses of RO5024048 or placebo. Follow-up is 7-10 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female adults, 20 to 55 years of age, inclusive
* Body mass index (BMI) 18 - 30 kg/m2 inclusive
* Non-smoker, or previous smoker who discontinued smoking \>/= 6 month prior to study entry
* Japanese subjects must be first generation: born in Japan, not having lived outside Japan \>5 years, able to trace maternal and paternal Japanese ancestry
* Female subjects of childbearing potential and male subjects and their partners of childbearing potential must agree to use two forms of contraception
* Agree to abstain from alcohol consumption and from strenuous exercise up to 3 days before dosing and throughout study (including the follow-up visit)

Exclusion Criteria:

* Positive pregnancy test
* Males whose female partner is pregnant or trying to become pregnant
* Positive urine test for drugs of abuse
* Positive for alcohol
* Positive result on hepatitis B, hepatitis C, or HIV test
* Clinically significant disease or abnormalities in laboratory parameters
* Participation in an investigational drug, biologic or device study within 3 months before study drug administration
* Donation or loss of any blood over 450 mL within 3 months before study drug administration
Effect of Endurance Training-Induced Coenzyme Q10 (CoQ10) Supplementation on Myokine, Exerkine Secretion and Cognitive Functions in Long-Distance Runners

The goal of this clinical trial is to learn if CoQ10 amplifies endurance training-induced myokine and exerkine secretion and if those changes influences cognition in long-distance runners.

Does 4-week high-dosage CoQ10 supplementation increase the secretion of myokine, exerkine sercetion? Does the above-mentioned intervention improve the cognitive function in long distance runners?

Participants will:

Take CoQ10 or a placebo every day for 4 weeks. Visit the laboratory once every 4 weeks for checkups and tests. Keep their food and training diary.


Eligibility Criteria:
Inclusion Criteria:

* training experienced for minimum 2 years
* running training at least 2 times per week
* Personal Best on 10k (\<50 minutes)

Exclusion Criteria:

* taking supplements which can interrupt primary outcomes (vitamin D, omega-3 fatty acids)
* injured in last 6 months to avoid n number reduction
Evaluation of Efficacy of Lycium Barbarum Polysaccharide in People With Subthreshold Depression

Lycium barbarum, a traditional Chinese herbal medicine, is a commonly used herb in the traditional Chinese pharmacopoeia . Its main active ingredient, lycium barbarum polysaccharide (LBP), is reported to have neuroprotective effects. Animal studies suggested that LBP has neuroprotective effect on optic ganglion cells. In animal models of depression, LBP can improve depressive symptom by improving synaptic plasticity. However, its clinical effect remains to be studied. We will conduct a 6-week double-blind, randomized, placebo-con-trolled trial in people with subthreshold depression.The purpose of this clinical trial is to investigate the efficacy of LBP in people with subthreshold depression.


Eligibility Criteria:
Inclusion Criteria:

1. 15-25 scores in the Beck Depression Rating Scale (BDI- II)
2. There is no contraindication of taking LBP.

Exclusion Criteria:

1. Current treatment for a mental health problem from a mental health professional
2. Current and lifetime history of psychiatric disorders (e.g major depressive disorder, as ascertained by CIDI
3. Systemic disease requiring regular medication.
4. There are suicidal ideation, suicidal attempt, suicide behavior and attempted suicide.
5. Dislike of or allergy to goji berry
6. Hormone or Endocrine therapeutic drugs are being taken.
7. Long-term use of lycium chinensis in recent three months
Evaluation of the Short and Long Term Performance and Clinical Outcomes of the Crux Vena Cava Filter System

The Crux Vena Cava Filter (VCF) Registry is a clinical study, sponsored by Volcano Corporation, to evaluate the short and long term performance and clinical outcomes of the Crux Vena Cava Filter System.

The Crux VCF Registry is a non-randomized clinical study, sponsored by Volcano Corporation, to evaluate the short and long term performance and clinical outcomes of the Crux VCF System. The registry includes consecutive patients treated with the Crux VCF in a post-market (commercial) setting with data collection at the implant procedure through 2 years post implant or to filter retrieval, whichever comes first. Patients may also be enrolled (roll-in) from a previous Crux VCF implant within the previous 6 months. Follow up assessment will be performed at 6, 12 and 24 months post-implant and at the time of retrieval, if performed.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is \>18 years of age.
2. Patient or their legally authorized representative understands the research nature of the study and is willing and capable of providing informed consent.
3. Scheduled for and receives a Crux VCF implant or;
4. Have previously had a Crux VCF implanted within the previous 6 months.

Exclusion Criteria:

1. Patient is scheduled for filter implant, but did not have a Crux VCF filter implanted due to anatomical exclusions or technical failures.
2. Patients unwilling or unable to comply with the protocol and provide informed consent.
3. Female patient of childbearing potential who is pregnant (she must have negative pregnancy test within the 48 hours prior to implantation and any retrieval procedure)
4. Patient is participating in another device or drug clinical trial that interferes with this protocol follow up schedule.
The Trans-cutaneous Effects on Physiological Tremor Entertainment During tACS

Transcranial alternating current stimulation (tACS) is a noninvasive neuromodulation method that works by passing alternating electric current between electrodes where at least one of them is attached to the head. This has been shown to have effects on the motor system, cognition and behavior. The exact mechanism by which tACS causes such effects is not fully understood. Some studies suggests a contribution from the stimulated peripheral nerves present in the scalp rather than direct brain effects. To test this hypothesis two arms will be done. First, 12 subjects (arm 1) will be stimulated using focused 4x1 montage with gel-filled cup-electrodes over the motor cortex and the effects will be compared between anesthetized and non-anesthetized scalp. The effects of anesthetizing the scalp will be tested on three different stimulation amplitudes off (0 mA), low (0.5 mA) and high (2.5 mA). Then, 10 subjects (arm 2) will be stimulated over the contralateral arm to exclude any direct brain stimulation effects and to test if peripheral nerve stimulation can entrain the tremor. Three outcome measurements will be measured during the experiments which are: tremor entrainment, sensation intensity and sensation threshold.


Eligibility Criteria:
Inclusion Criteria:

* Above 18
* Signed informed consents

Exclusion Criteria:

* Pregnancy
* History of Epilepsy
* Family history of Epilepsy
Assessment of PFT, Safety, and PK of Zileuton Injection in Asthma Patients

A single intravenous injection of zileuton (150 or 300 mg) will be administered to patients with stable asthma. The goals will be to determine if zileuton i.v. can produce a rapid increase in FEV1/PEFR and when this effect can be seen. The safety of this route of administration of zileuton will also be studied. PK will be obtained in a population based method.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients 12 years of age or older
2. Diagnosis of asthma by current ATS guidelines
3. FEV1 of 4-80%.
4. Reversibility of at least 13% after bronchodilator treatment
5. Must be willing to with hold SABA for 6 hours and ICS for 24 hours prior to treatment.
6. Informed consent

Exclusion Criteria:

1. Females of child bearing potential unless using birth control
2. Uncontrolled systemic disease
3. Known hypersensitivity to zileuton or components of zileuton injection.
4. Upper or lower respiratory tract infection within the last 2 weeks
5. Admission to hospital or ER visit for asthma exacerbation within the last 3 months
6. Course of oral or parenteral steroids within the last 3 months
7. Current smoker or H/O \> 15 pack years
8. Creatinine \> 1.5 x ULN
9. ALT \> 3 x ULN
10. BP \< 100 (systolic)
11. H/O HIV
12. H/O alcohol or drug abuse
13. Patients taking Xolair, theophylline, montelukast, zafirlukast, nedocromil, cromolyn sodium, Zyflo (within the past 7 days), warfarin, propranolol, inhaled anti-cholinergics, or LABA.
14. Pregnant or breast feeding females
15. Current participation or participation in an experimental drug study within 30 days.
Basic Life Support (BLS) and Barriers to Cross-Cultural Education

This is a randomized, multi-center intervention trial comparing two educational programs on healthcare provider performance in the Botswana national hospital system. This study addresses the critical question of how to effectively and consistently measure and associate CPR knowledge and psychomotor skills, enabling the optimization of the learners' environment.

Context: The World Health Organization (WHO) estimates that more than 16 million people die from cardiovascular diseases each year, accounting for more than one-third of global deaths. Almost half of these deaths take place in hospitalized settings. Standard acute medicine education programs have had limited success in training hospital based healthcare providers to acquire, retain, and transfer knowledge and skills to impact patient outcomes in both developed and developing countries. There is a gap between the cognitive knowledge and critical thinking skills attained during courses and the technical and team skills actually performed by hospital-based healthcare providers. This gap between existing knowledge and performed skills restricts care delivery, underutilizes available resources, and contributes to the number of preventable deaths. This gap is further accentuated in resource limited settings, where barriers to implementation of successful acute medicine training programs are often accentuated.

Primary Objective:

1. To determine selected cognitive knowledge and critical thinking skills which are associated with technical and team skills performance assessed immediately following Basic Life Support (BLS) for Health Care Providers course training.

Secondary Objectives:

1. To identify cultural, healthcare environment and educational barriers that currently impede acquisition, retention, and transfer of knowledge and skills in acute medicine educational programs in resource limited settings.

Eligibility Criteria:
Inclusion Criteria:

1. Healthcare providers involved in patient contact.
2. Participation in BLS for Healthcare Provider Course

Exclusion Criteria:

1. Have received formal Basic Life Support training in previous 12 months.
2. Inability to perform or complete cognitive and skills assessment testing (pre, immediate post, 3 or six month post).
3. Healthcare personnel performing an educational rotation at the district or referral hospital will not be eligible due to loss of follow-up.
A Study of Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients.

This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic renal anemia;
* on dialysis therapy for at least 12 weeks before screening;
* receiving sc epoetin for at least 8 weeks before screening.

Exclusion Criteria:

* women who are pregnant, breastfeeding or using unreliable birth control methods;
* administration of another investigational drug within 4 weeks before screening, or during the study period.
Treatment of Non-Dislocated Midshaft Both-Bone Fractures

The investigators created a randomized clinical trial to find out what kind of treatment is optimal for non-dislocated both-bone midshaft forearm fractures.

Children who arrive at the emergency unit with a non-dislocated both-bone midshaft forearm fracture will be asked to join the trial. After informed consent we will do a randomization between 6 weeks above elbow cast and 3 weeks above elbow cast in combination with 3 weeks under elbow cast.

Outpatient clinic visits till a follow-up of 6 months. During these visits we will investigate: consolidation and dislocation on X-ray, function of both arms, complaints in daily living and complications.

Eligibility Criteria:
Inclusion Criteria:

* Both-bone midshaft forearm fracture
* Age \< 16 years old

Exclusion Criteria:

* Dislocation
* Fracture older than 1 week
* No informed consent
* Refracture
* Open fracture (Gustillo 2 and 3)
* Torus fractures of both ulna and radius
Treatment of Tac-Expressing Cutaneous T-Cell Lymphoma (CTCL) and Adult T-Cell Leukemia (ATL) With Yttrium-90 Radiolabeled Anti-Tac

The study purpose is to evaluate the clinical response to multidose administration of anti-Tac monoclonal antibody conjugated with 10 mCi 90Y in patients with Tac-expressing adult T-cell leukemia (ATL).

The study purpose is to evaluate the clinical response to multidose administration of anti-Tac monoclonal antibody conjugated with 10 mCi 90Y in patients with Tac-expressing adult T-cell leukemia (ATL). This study represents an extension of phase I trial (Clinical Project #90-C-0043, FDA IND #3469) which permitted the administration of 5 mCi, 10 mCi, and 15mCi 90Y-anti-Tac to patients with ATL. We propose to administer 90Y-anti-Tac (10 mCi doses) to patients with Tac-expressing ATL who are over 18 years of age and who fill the patient eligibility criteria.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

Histologically confirmed adult T-cell leukemia/lymphoma (ATL) or cutaneous T-cell lymphoma (CTCL).

Reactivity of at least 10% of peripheral blood, lymph node, or dermal malignant cells with anti-Tac as determined by immunofluorescent staining or soluble IL-2 receptor level greater than 1,500 U required.

All stages of Tac-expressing T-cell leukemia and lymphoma eligible except Stage I CTCL.

All forms of ATL eligible, including the "smoldering" type as well as aggressive disease.

No symptomatic CNS disease other than tropical spastic paraparesis.

Asymptomatic CNS disease with demonstrable malignant cells in the CSF allowed (such patients receive CNS therapy, e.g., intrathecal methotrexate and/or CNS irradiation, as appropriate).

PRIOR/CONCURRENT THERAPY:

Biologic Therapy: Not specified.

Chemotherapy:

CTCL must have failed initial chemotherapy.

ATL may or may not have had prior chemotherapy.

At least 4 weeks since prior cytotoxic chemotherapy.

Endocrine Therapy: Not specified.

Radiotherapy: At least 4 weeks since prior radiotherapy.

Surgery: Not specified.

PATIENT CHARACTERISTICS:

Age: 18 and over.

Performance status: Not specified.

Life expectancy: Greater than 1 month.

Hematopoietic: WBC at least 3,000, Platelets at least 75,000.

Hepatic: Not specified.

Renal: Not specified.

Other:

No pregnant women.

Negative pregnancy test required of fertile women.
Active Breathing Coordinator-based vs VisionRT-based Deep Inspiration Breath-hold for Radiation for Breast Cancer

Female patients treated with radiation for left-sided breast malignancy will undergo alternate fractions of Active Breathing Coordinator (ABC)-assisted and VisionRT-assisted Deep Inspiration Breath-Hold (DIBH).

Female patients treated with radiation for left-sided breast malignancy will undergo alternate fractions of ABC-assisted and VisionRT-assisted DIBH. Residual motion during breath-hold will be quantitatively assessed using MV fluoroscopy from the treatment beam itself (i.e., no additional radiation dose). The dosimetric impact of residual motion on organs at risk (heart and lung) will be assessed by applying rigid and/or deformable displacements to the planning CT images, computing the 3D dose map and comparing with the original planned dose map.

Eligibility Criteria:
Inclusion Criteria:

* Women with diagnosis of breast malignancy
* Women whom requires left chest wall post-mastectomy radiation with or without bolus
* Age ≥ 18 years.
* Performance status ECOG \</=3
* Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately Ability to understand and the willingness to sign a written informed consent.
* Patient must be able to maintain a 30 second breath hold.
* Conventional chest wall radiation delivery dose of 50.4 Gy/ 28 fractions with or without a boost (boost will not be evaluated for endpoints)

Exclusion Criteria:

* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Xerostomia in Patients With a Life-limiting Condition or Frailty

Xerostomia, the subjective feeling of dry mouth, is a common symptom during the last year of life in patients with a life-limiting condition or frailty. Xerostomia leads to functional alterations (such as burning sensations, an altered taste perception, and difficulties with chewing, swallowing, and speaking), has disabling social consequences and significantly downgrades the perceived quality of life. It is an under-exposed and under-treated symptom often caused by alterations in the quality and quantity of saliva.

Locally administered pilocarpine could be a promising drug in this regard as it alleviates xerostomia by increasing the production of saliva.


Eligibility Criteria:
Inclusion Criteria:

* have a life-limiting condition or frailty
* have the complaint dry mouth ≥ 5 on an 11 point numerical rating scale (ranging from 0= no dry mouth to 10= worst dry mouth ever)
* fulfil the single SQ 'Would I be surprised if my patient dies within the year? (no)

Exclusion Criteria:

* their life expectancy is less than 4 weeks (the primary endpoint at 4 weeks)
* they have had radiotherapy to the salivary glands or suffer from Sjögrens disease (impact on dry mouth)
* cognitively impaired to such an extent that there is insufficient understanding to complete questionnaires
Effect of Pyridostigmine (Mestinon) on Muscle Strength in Myasthenia Gravis

A randomized, placebo-controlled, double-blinded cross-over study evaluating and quantifying the effect of pyridostigmine on muscle strength and symptoms in Myasthenia Gravis (MG)

The study aims to evaluate and quantify the effect of pyridostigmine on symptoms and muscle strength in newly-diagnosed patients and patients on stable medication.

Pyridostigmine treatment is initiated in the vast majority of MG patients. No studies have quantified the effect in a randomized trial, and no studies have examined the potential difference in effect in newly diagnosed patients as compared to patients on stable, antimyasthenic medications.

The study will investigate the effect in two groups

1. Newly diagnosed, treatment-naive patients.
2. MG patients on stable antimyasthenic medication.

Eligibility Criteria:
Inclusion Criteria:

* MG verified by a) anti-body, or b) single-fiber EMG and/or decrement on ENG.

Exclusion Criteria:

* Anti-MuSK
* Known cardio-pulmonary disease
* Known neuropathy
* Known myopathy
* Known malignant disease
* Pregnancy or breastfeeding
* Mechanic ileus, urinary tract obstruction, peritonitis

De-novo MG Eligibility Criteria

* MG diagnosis \< 2 months, no prior antimyasthenic medications

Chronic MG Eligibility Criteria

* MG diagnosis \> 1 year, and stable pyridostigmine dosis
Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Patients With LA-NPC

Nasopharyngeal carcinoma (NPC) is a malignant tumor that originates in nasopharyngeal epithelial cells. It is common in southern China and Southeast Asia, but the incidence rate is low in most parts of the world. According to the World Health Organization survey, 80% of nasopharyngeal carcinomas occur in China, with high incidence in southern China, as high as 30-50/100,000, such as Guangdong, Guangxi, Hunan, and Fujian. In 2015, Chinese cancer statistics showed that there were about 60,600 new cases of nasopharyngeal carcinoma in China, and the number of deaths was about 34,100. Radiation therapy is the main treatment for nasopharyngeal carcinoma. Early stage I and IIa achieved a 5-year survival rate (OS) of 90% and 84%, respectively . However, the treatment outcomes of most patients with locally advanced nasopharyngeal carcinoma are not ideal.


Eligibility Criteria:
Inclusion Criteria:

1. Age, 18-75 years old.
2. Patients with newly histologically confirmed NPC.
3. WHO Type Ⅱ and Ⅲ.
4. Tumor staged as Ⅲ-ⅣA (according to the 8th AJCC edition).
5. No serious organ dysfunction of heart, lung, liver, kidney.
6. No distant metastasis.
7. Hematological examinations:WBC≥3.5×109/L, NEUT#≥1.5×109/L, PLT≥90×109/L, HB≥90g/L.
8. Normal liver function test：Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤1.5×ULN，creatinine clearance ≥60 ml/min.
9. Patients must be given written informed consent.

Exclusion Criteria:

1. age \>75 years or \<18years.
2. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
3. History of previous radiotherapy and chemotherapy.
4. Known or suspected to be allergic to platinum and Nab-paclitaxel.
5. Pregnancy or lactation.
6. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial.
7. Peripheral sensory neuropathy\> grade 1.
8. Uncontrolled heart clinical symptoms or diseases.
Venous Thrombosis in Turner Syndrome

In the literature, cases of thrombosis in the venous system have been described in girls and women with Turner syndrome. By screening a group of women with Turner syndrome, the researchers wish to find out if this condition is more frequent in this patient population.

In the literature cases of thrombosis in the venous system has been described in girls and women with Turner syndrome. By screening a group of women with Turner syndrome we wish to find out if this condition is more frequent in this patient population. Participants are examined with screening blood tests evaluating thromboembolic disturbances.

Eligibility Criteria:
Inclusion Criteria:

* Turner syndrome verified by karyotyping
* Aged 18 or above

Exclusion Criteria:

* Malignant disease
* Treatment with anticoagulants