cyrilzakka/clinical-trials huggingface dataset:
Cladribine in Combination With GAP in Patients With Refractory/Relapsed Acute Lymphoblastic Leukemia

The vast majority of patients with ALL will die of the disease, and no standard chemotherapy regimen were defined for patients with relapsed/refractory ALL.Our previous experience has shown that Cladribine in combination of GAP (G-CSF priming, low dose cytarabine, and Pegaspargase) are effective with tolerable toxicity profiling.Thus, this phase 2 clincial trial is going to evaluate the efficacy and safety of cladribine in combination with G-CSF, low-dose cytarabine and Pegaspargase (C-GAP) in patients with refractory/relapsed acute Lymphoblastic Leukemia

ALL is common in the elderly patients, who can not tolerate the intensified treatments. The vast majority of patients with ALL will die of the disease, and no standard chemotherapy regimen were defined for patients with relapsed/refractory ALL. Our previous experience has shown that Cladribine in combination of GAP(G-CSF priming, low dose cytarabine, and Pegaspargase) are effective with tolerable toxicity profiling.Thus, this phase 2 clincial trial is going to evaluate the efficacy and safety of cladribine in combination with G-CSF, low-dose cytarabine and aclarubicin (C-CAG) in patients with refractory/relapsed acute myeloid leukemia.

Eligibility Criteria:
Inclusion Criteria:

* Men and women;
* Clinical diagnosis of Relapsed/Refractory ALL;
* ECOG performance status (PS) score 0-3;
* AST and ALT \<=2.5 times the institutional ULN;
* Total bilirubin \<=2.0 times the institutional ULN
* Serum creatinine\<2.0 times the institutional ULN;
* Subjects should take effective contraceptive measures，and serum or urine pregnancy tests must be negative during the screening and study periods in women subjects;
* Patients should understand the disease and voluntarily receive the study regimen and follow-up.

Exclusion Criteria:

* Concurrent diagnosis of tumors other than ALL, with exclusion of superficial bladder cancer, basal cell and squamous cell carcinoma, cervical intraepithelial neoplasms (CIN), prostatic intraepithelial neoplasms(PIN);
* Active viral or bacterial infection that would impair the ability of the subject to receive protocol therapy;
* Concurrent autoimmune hemolytic anemia or immune thrombocytopenia;
* Subjects suffered from AIDS，active hepatitis B or C virus infection;
* Dementia or altered mental status that would prohibit the understanding or rendering of informed consent;
* Be allergic to any component of C-GAP regimen;
* Subjects ever exposed to cladribine or CAG-based regimen.
Surveillance and Follow-up for Latent Tuberculosis Infection and Risk of Developing Active Tuberculosis in Patients Receiving Long-term Dialysis

To follow-up the latent tuberculosis infection and the risk of developing active tuberculosis in patients receiving long-term dialysis

Tuberculosis (TB) remains an important infectious disease worldwide. Taiwan is still an edemic area. In 2008, there is an incidence of 62 persons having TB per 100,000 population. To control TB, we should prevent further TB transmission via early diagnosis and treatment of latent TB. In screening the risk population for TB, patients with renal failure acquiring long-term dialysis, in addition to close contacts, have higher incidence and mortality than general population. Moreover, the risk for active TB in dialysis patients is ten to 25 times larger. In Taiwan, the dialysis group is important because it has higher prevalence (2228 per in per million people by 2009 annual report of United States Renal Data System) than other countries in the world. In particular, the dialysis patients usually has an extrapulmonary presentation for their TB, so diagnosis is always delay. Hence, we should detect latent TB in those dialysis patients for monitor them from active tuberculosis.

Currently, interferon-gamma release assays (IGRAs) are used for finding out those with latent TB and have been proven useful for those being immunocompromised, and having BCG vaccination. For dialysis patients, IGRAs have been tested and been considered better than skin tuberculin test. However, previous studied rarely observed the patients receiving peritoneal dialysis. Besides, those cross-sectional studies used the indirect evidence for diagnosis and lacked longitudinal follow-up. We thus conducted this study for observing the prevalence of latent TB in those receiving hemodialysis or peritoneal dialysis by using IGRAs. We also kept one-year follow-up for the primary outcome of active TB occurrence.

Eligibility Criteria:
Inclusion Criteria:

* age equal to or more than 18-years old
* having received dialysis more than 3 months

Exclusion Criteria:

* Positive HIV test
* Liver cirrhosis, Child-Pugh class C
* Receiving long-term systemic corticosteroid use
* Receiving chemotherapy within recent three months
* Life span is less than one year
* Being suspected to have active tuberculosis
A Study of RO5045337 [RG7112] in Patients With Advanced Solid Tumors

This study will determine the maximum tolerated dose and the optimal associated 4 weekly dosing schedule of RO5045337, administered as monotherapy in patients with advanced solid tumors. A first cohort of patients will receive the starting dose of 20mg/m2/day, once daily for 10 days in each 28 day cycle. Subsequent cohorts of patients will receive dose escalations, and possible changes in dosing schedule, based on tolerability and pharmacokinetic knowledge gained from prior treatment cohorts. The anticipated time on study treatment is until disease progression or intolerable toxicity.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* solid tumor malignancies;
* failed prior therapies, or no standard therapy available;
* ECOG performance status of 0-2.

Exclusion Criteria:

* patients receiving any other agent or therapy to treat their malignancy;
* pre-existing gastrointestinal disorders which may interfere with absorption of drugs;
* clinically significant cardiovascular disease.
Restoring Central Motor Control Extension

Motor skill training therapy aims to improve the brain's control of walking and can improve clinic-based measures of walking in older adults. However, it is unknown whether the benefits of motor skill training extend to real world mobility measures. The investigators will test the effects of motor skill training on measures of community mobility of older adults and assess the mechanisms through improved motor control at the level of the brain. These results will inform intervention approaches to maintain community mobility of older adults and prevent disability and institutionalization.


Eligibility Criteria:
Inclusion Criteria:

* 65 years of age and older
* Ambulatory without an assistive device or the assistance of another person
* Usual 4 meter gait speed \> 0.60 m/s and \< 1.2 m/s
* Physician clearance to participate in a moderate intensity exercise program
* Not meeting physical activity recommendations defined as reporting less than 150 minutes of moderate intensity activity per week in the past month.

Exclusion Criteria:

* persistent lower extremity pain that is present on most days of the week
* back pain that is present on most days of the weeks and interferes with walking and - activities of daily living or back pain that increases with walking
* refuse to walk on a treadmill
* plans to move out of the area in the next 5 years
* dyspnea at rest or during activities of daily living or use supplemental oxygen (CHF, COPD)
* any acute illness or medical condition that is not stable according to the approving physician
* resting systolic blood pressure ≥ 200 mm Hg or diastolic blood pressure ≥ 100 mm Hg or resting heart rate \> 100 or \< 40 beats per minute
* diagnosed dementia or cognitive impairment defined as modified Mini-Mental State (3MS) examination \<79
* hospitalized in the past 6 months for acute illness or surgery, other than minor surgical procedures
* severe visual impairment f- ixed or fused lower extremity joints such as hip, knee or ankle
* lower extremity strength \<3/5 on manual muscle testing
* lower extremity amputation
* progressive movement disorder such as Multiple Sclerosis, Amyotrophic Lateral Sclerosis or Parkinson's disease
Randomized Double-blind Study on the Treatment of Osteoarthritis of the Bilateral Knee: Autologous Bone Marrow Concentrate vs. Hyaluronic Acid

OA-bi-Blind is a randomized double-blind study on the treatment of osteoarthritis of the Bilateral knee: autologous bone marrow concentrate vs. hyaluronic acid.

a randomized, controlled, double-blind study and we will be evaluated and compared the clinical and radiological results of concentrated autologous bone marrow against the hyaluronic acid in patients with bilateral knee osteoarthrosis . In randomization, one knee will be treated with autologous bone marrow concentrate and other knee with hyaluronic acid, then every patient is considered both in control and treatment group, limiting the heterogenity between groups and will not be informed of the knee assigned to the treatment group.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients, aged between 18 and 75 years;
2. Bilateral symptomatic knee osteoarthritis (Kellgren-Lawrence grade 1-4);
3. Failure after two months of conservative treatment;
4. Capacity and consent of patients to participate actively in the rehabilitation protocol, follow-up clinic and radiology protocol;
5. Signature of informed consent.

Exclusion Criteria:

1. Patients incapable of discernment;
2. Patients with malignancy
3. Patients with rheumatic diseases;
4. Patients with diabetes;
5. Patients with metabolic disorders of the thyroid;
6. Patients belonging abuse of alcohol, drugs or medications;
7. Patients with misalignment of the lower limbs than 10 °;
8. Body Mass Index\> 40;
9. Patients with a history of trauma or intra-articular infiltration of therapeutic substances within 6 months prior to treatment.
Community Based Study on Occupational Asthma

To examine the occupations, industries and exposures in the work-place which were associated with a high risk for asthma and other adverse respiratory health effects, with particular emphasis on specific exposures of predominantly female occupations (irritants, detergents and other asthmagens), and of other high risk major occupations which had not been adequately examined.

BACKGROUND:

Respiratory diseases are strongly related with exposure in the workplace. A considerable proportion of adult onset asthma is associated with these exposures. The importance of occupational risk factors for asthma has been underestimated, particularly among women. The occupational asthma study (ECRHS-OA) forms part of a wider international multicentre survey on respiratory health (European Community Respiratory Health Survey-ECRHS). The first phase of the ECRHS was conducted in 1991/92 and examined risk factors for asthma and atopy in subjects aged 20-44 years. The study updated (ECRHS-II), following-up approximately 17,000 young adults from 12 countries (Australia, Belgium, France, Germany, Iceland, Italy, Norway, Spain, Sweden, Switzerland, UK and USA).

The study provided valid and precise estimates on the importance of specific occupations, industries and exposures in relation to asthma incidence and prevalence, similar estimates for other respiratory symptoms and diseases and also for declines in pulmonary function.

DESIGN NARRATIVE:

Longitudinal, community-based, multicenter study. Those subjects who took part in the first occupational asthma study survey were re-contacted in 1999, to determine risk factors for incidence and remission of asthma, other respiratory symptoms, atopy, changes in bronchial responsiveness and lung function. Subjects were asked to perform a forced spirometry, methacholine challenge and to provide blood samples for IgE testing. A questionnaire administrated by trained interviewers was delivered requesting information on respiratory symptoms and diseases, socio-demographic factors, tobacco smoking, complete occupational history since the last survey, environmental exposures, family history, diet, treatment and use of health services. Modular occupational questionnaires were developed for subjects employed as cleaners, homemakers, welders, metal workers, nurses, and subjects exposed to organic dusts in the paper and textile industries.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Group Therapy for Postpartum Depression

This study will compare standard individual treatment to group therapy for the treatment of postpartum depression.

Ten to twenty percent of new mothers experience major depression in the postpartum period or postpartum depression (PPD). This condition poses a risk for disturbances in the mother-infant relationship as well as for developmental delays and subsequent psychopathology in their children. Thus, and investigation of the efficacy of a relational approach that focuses on improving the mother's sense of competence in the parenting role, and reducing depressive symptoms and social isolation through group therapy is warranted.

Patients are randomly assigned to either relational group treatment or to standard individual treatment. Assessments of maternal and infant functioning, mother-infant and father-infant relations, parenting stress, and marital conflict and conducted pre- and post-treatment, at 12 months post-treatment, and when infants are 12 and 24 months of age.

Eligibility Criteria:
Inclusion Criteria:

* Major depression with an infant under 7 months of age

Exclusion Criteria:

* Bipolar disorder
* Schizophrenia
* Organic brain syndrome
* Antisocial personality disorder
* Current psychosis or mania
* Lifetime history of mental retardation
* Current alcohol or substance abuse
* Cognitive disability
* Infants born more than 6 weeks premature or with major medical conditions or developmental disabilities
Phase I Study to Evaluate the Safety of Dexibuprofen 200mg Under Fasting and Fed Conditions

Phase I Study to Evaluate the Safety of Dexibuprofen 200mg (Apsen Pharmaceuticals A / S.) After a Single and Multiple Dose Oral Administration in Healthy Participants of Both Sexes Under Fasting and Fed Conditions.

A single oral dose of test medicine will be administered to participants in a practical period with the aid of 200 mL of water at room temperature. During administration, participants should stay in seated position. Participants will be confined at least 12 hours prior to administration and will remain for about 24 hours after the same, totaling about 36 hours of confinement.

After 36 hours of confinement the participantes will proceed to the multi-dose use phase for seven days in fed conditions.

To assess safety, an evaluation of the vital signs, laboratory tests and health status of the participants will be carried out throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participant able to understand and sign the informed consent of the study;
* Healthy research participant, of both sexes, aged between 18 and 50 years, with BMI between 18.50 and 29.99 kg / m2;
* Participant considered healthy by evaluating the medical history, vital signs and general clinical examination;
* The results of clinical laboratory tests (biochemistry, hematology, serology, urinalysis and ECG certified by cardiologists) within the normal range established by the laboratory or changes that are considered not clinically significant by study physician.

Exclusion Criteria:

* History of any major surgery in the last three months;
* History present or previous history of any cardiac event, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric, hematologic, considered by the investigator as clinically significant and can endanger the participant's health;
* History of chronic alcohol abuse, drugs, drugs and / or smoking in the last 6 months;
* Known hypersensitivity to dexibuprofen, ibuprofen or its related (other nonsteroidal anti-inflammatory drugs) as well as components present in the formulation;
* History of use of drugs that potentially interfere with the kinetics / dynamics dexibuprofen or any other medication considered clinically significant by the investigator with time less than 7 times of drug half-life preceding the period of inclusion;
* Regular consumption of grapefruit and / or their derivatives;
* Pregnant women and nursing mothers;
* Donation or loss of 450 ml or more of blood within 3 months before the study and / or hospitalization for any reason, up to 4 weeks before the beginning of it.
* Participation in any clinical trial in the last 12 months preceding the start of the study.
Assessing the Link Between Smoke Carcinogen Biomarkers and Lung Cancer Risk - 1

Lung cancer is the leading cause of cancer death in the United States. Currently it remains impossible to predict which smokers will get cancer. Each puff of a cigarette delivers a mixture of over 60 known carcinogens. Biomarkers that quantify carcinogen levels and metabolism are a useful tool and available to use. The purpose of this study is to assess the link between tobacco smoke carcinogen biomarkers and the risk of developing lung cancer.

Lung cancer is the leading cause of cancer death in the United States. Approximately 90% of lung cancer is caused by cigarette smoking. While most lung cancer cases occur in smokers or ex-smokers, only 15-25% of smokers will get lung cancer. Currently it remains impossible to predict which smokers will get cancer.

Each puff of a cigarette delivers, along with nicotine, a mixture of over 60 known carcinogens. Most of these carcinogens require metabolic activation before they can negatively affect cell DNA and cause cancer. Biomarkers that quantify carcinogen levels and metabolic activity of carcinogens are a useful tool and available to use. The purpose of this study is to assess the link between tobacco smoke carcinogen biomarkers and the risk of developing lung cancer.

This observational case-control study will involve a random selection from a group of smokers who are participating in the Prostrate, Lung, Colon, and Ovarian Cancer (PLCO) Screen Trial. The chosen cases will include 300 incident lung cancer cases and 300 controls (participants who have had no diagnosis of lung cancer). Demographic and baseline data from the PLCO database will be obtained. Prior baseline blood samples from the PLCO trial will be obtained as well. Based on age, sex, and smoking history, participants will be grouped into triplets in order to pool their blood samples. These samples will then be analyzed to determine whether distributions of biomarker levels in lung cancer participants differ from those in non-lung cancer participants. This study will not involve recruitment of any participants, as data and samples from the PLCO trial will be used and no new blood samples will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Screening arm participants in the Prostate, Lung, Colon, and Ovarian Screen Trial (PLCO)
* Reported smoking on baseline questionnaire of PLCO
* Contributed biorepository samples

Exclusion Criteria:

* Unstable physical or mental health
A Clinical Trial to Evaluate Dichloroacetate (DCA) as a Treatment for Endometriosis-associated Pain

This is a single-arm open label exploratory clinical trial to evaluate dichloroacetate (DCA) as a possible treatment for treatment of endometriosis-associated pain

Endometriosis is a chronic condition usually affecting women throughout their reproductive lives. It is defined as a growth of endometrial-like tissue (womb lining) outside the uterus (womb) and is associated with chronic pelvic pain that can be frequent and severe, resulting in tiredness, lower quality of life and difficulties in getting pregnant. Current treatments are unsatisfactory and there is an unmet need for new medical treatment for endometriosis. Research findings from our laboratory have shown that women with endometriosis have more lactate in their pelvis. In laboratory models of endometriosis, we have tested dichloroacetate (DCA), a compound used to treat metabolic disorders in children. Our results showed that DCA could stop the growth and survival of endometriosis cells and reduce lactate production. In our study we plan to investigate if we can we can recruit and retain women into a trial using this treatment. We will recruit 30 women aged 18 or over, with pelvic pain and a diagnosis of endometriosis within the last three years. Participants will complete informed consent, be willing to comply with the treatment and use contraception throughout the trial. We will recruit patients over six months at Royal Infirmary of Edinburgh. Women who consent will take a daily dose of DCA capsules for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 or over
* Weight between 50 and 100kg
* Pre-menopausal
* Superficial peritoneal endometriosis (ASRM Stage I or II) at laparoscopy, performed within the last three years (and \>2 weeks from surgery)
* Pelvic pain for longer than six months
* Average pain score of ≥ 4 over the four weeks prior to treatment
* Willing to comply with the treatment
* Willing to use contraception throughout the trial
* Willing and able to complete informed consent

Exclusion Criteria:

* Evidence of ovarian endometrioma or deep endometriosis (based upon current surgical staging or most recent imaging)
* Women who are pregnant or actively trying to get pregnant
* Known allergy or hypersensitivity to any excipient of DCA
* Breastfeeding
* Clinical evidence of pre-existing neuropathy
* Diabetes
* History of liver disease
* History of kidney disease
* Taking part in a CTIMP or other interventional non-CTIMP studies
* Patient on combination antiretroviral therapy
* History of malabsorption syndrome or substantial amount of small bowels or stomach removed
Study on the Effect of Capacity Shock Intervention Under Goal-directed Hemodynamic Management on P-V Loop

By observing the changes of P-V loop in capacity shock intervention Under Goal-directed Hemodynamic Management in patients undergoing total knee replacement, we investigate the effect of capacity shock on cardiac contractility and work in order to seek a more effective target plan of capacity shock for intraoperative patients.

Objective:By observing the changes of P-V loop in capacity shock intervention Under Goal-directed Hemodynamic Management in patients undergoing total knee replacement, we investigate the effect of capacity shock on cardiac contractility and work in order to seek a more effective target plan of capacity shock for intraoperative patients.

Methods:20 patients with total knee replacement were enrolled in this study. Capacity shock therapy was used in Group A(n=10) and conventional strategy was used in Group B (n=10). V(t) was measured and calculated using TEE and P(t) was acquired by the analysis of patients'radial artery pressure waveform. We set five time points of parameter acquisition: after grouping (T1), the first shock completion(T2), the second shock completion (T3), 1h after shock treatment (T4), and operation completion(T5). We make up the P-V loop fitting P(t) and V(t) at each time point after the calibration of cardiac cycle.

Eligibility Criteria:
Inclusion Criteria:

ASAI-II age 40- 70 weight 48 - 72 kg.

Exclusion Criteria:

Body mass index \>30 or \<15 kg/m2 Valve heart disease Left ventricular ejection fraction (LVEF) is less than 50% History of lung disease Preoperative arrhythmic disorder Permanent pacemaker Need for mechanical heart Support, Severe extrinsic vascular disease Valve dysfunction OED monitoring probe insertion contraindications Patients with preoperative assessments