cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of CC-486 in Previously Treated Patients With Locally Advanced or Metastatic Nasopharyngeal Carcinoma

The purpose of this study is to evaluate the safety and efficacy of CC-486 in previously treated patients with locally advanced or metastatic nasopharyngeal carcinoma having failed one to two previous regimens, including platinum-based chemotherapy. Participants will be enrolled according to a Simon two-stage design; if the predefined activity is met (\>4 responses \[complete response; partial response {CR/PR}\] out of the first 17 evaluable participants based on independent radiological assessment), then the study will continue to enroll an additional 34 participants. If 4 or less responses out of 17 are observed, then the study enrollment will be stopped.


Eligibility Criteria:
Inclusion Criteria:

* Age = or \> 18 years Histological or cytological diagnosis of undifferentiated or poorly differentiated nasopharyngeal carcinoma that is locally advanced or metastatic.
* Disease progression either clinically or radiographically after 1-2 previous regimens.
* Patient has received a platinum containing regimen. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Radiographically-documented measureable disease.
* Adequate organ and bone marrow functions.
* Willingness to follow pregnancy precautions.

Exclusion Criteria:

* History of, or current brain metastasis. Any other malignancy within 5 years prior to randomization with the exception of adequately treated in situ carcinoma of the cervix, uteri, or non-melanomatous skin cancer (all treatment of which should have been completed 6 months prior to enrollment), in situ squamous cell carcinoma of the breast, or incidental prostate cancer.
* Previous treatment with azacitidine (any formulation), decitabine, any other hypomethylating agent.
* History of gastrointestinal disorder or defect. Impaired ability to swallow oral medication. Persistent diarrhea or malabsorption.
* Active cardiac disease and human immunodeficiency virus (HIV) infection
* Active bleeding; pathological condition that carries a high risk of bleeding; risk of pseudoaneurysm of the internal carotid artery and carotid blowout syndrome.
* Major surgery within 14 days prior to starting Investigational Product or has not recovered from major side effects.
* Another investigational therapy within 28 days or 5 half lives of randomization/enrollment, whichever is shorter.
* Patient has not recovered from the acute toxic effects of prior anticancer therapy, radiation, or major surgery/significant trauma.
* Radiotherapy \< or = 4 weeks or limited field radiation for palliation \< or = 2 weeks prior to starting with the investigational product.
* Pregnancy/Breast feeding
* Any condition that places the patient at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study.
Physical Fitness Impact of Early Physiotherapy Intervention With a Standardized Exercise Therapy Program in Adult Patients Receiving Intensive Induction Chemotherapy for Treatment of Acute Leukemia During Extended Hospitalization.

This study aimed to investigate the impact of Physical therapy in adult patients receiving intensive induction chemotherapy for the treatment of acute leukemia during prolonged hospitalization. The study cohort included 150 patients. Primary objective is to compare the effect of a standardized rehabilitation program on physical deconditioning. This study has several secondary objectives of comparing and analyzing the status of sarcopenia, muscle strength, physical performance and the psychic dimension of this intervention. The 6 minutes walking test, Handgrip strength, impedance measurement, computed tomography, Short Physical Performance were used as measures of physical function. Hospital Anxiety and Depression Scale and European Organization for the Research and Treatment of Cancer-Quality of Life-Questionnaire-30 (EORTC-QLQ-30) were used as measures of depression and anxiety and quality of life of cancer patients. To investigate the impact of physical therapy, patients were assigned to the physical therapy group (experimental group) or the control group.These results will thus make it possible to promote access to physiotherapy and rehabilitation care, from diagnosis and during hospitalization, and to standardize practices.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient \>18 years
* Patient with acute leukemia eligible to receive intensive chemotherapy (induction phase) with predictable deep bone marrow aplasia (polynuclear neutrophils \<500mm3 for more than 8 days) requiring prolonged hospitalization with room confinement.
* Patient having signed the informed consent to participate in the study

Exclusion Criteria:

* Patient with disabilities or contraindications (significant cognitive or psychiatric disorders, significant cardiac or pulmonary pathology, neurological, joint, orthopedic or medical condition, etc.) following an exercise therapy program and carrying out follow-up defined by the protocol and in particular the physical performance tests.
* Active bleeding, acute thrombosis, ischemia, hemodynamic instability or uncontrolled pain
* No understanding of the French language
* Pregnant women, parturients and nursing mothers
* Persons deprived of their liberty by judicial or administrative decision
* People under duress psychiatric care
* Persons subject to legal protection
* Persons unable to express their consent
* Person not affiliated to a health insurance scheme or not beneficiary of a social security scheme.
Neuroregulatory Effect and Mechanism of tDCS on Medial Prefrontal Cortex in ASD

In this proposed study, a transcranial direct current stimulator is used to intervene in the medial prefrontal cortex of children with autism, and the efficacy of this intervention method is evaluated, as well as the internal mechanism of Autism Spectrum Disorders' intervention is discussed.

This is a randomized controlled double-blind trial. Using a transcranial direct current stimulator to stimulate the Autism Spectrum Disorders of children with autism, place an anode patch on Fz and a cathode patch on right cheek to observe whether it can improve social and cognitive function in autism. Parameter settings: The current size is 1.5mA. Treat twice a day for 20 minutes, for a total of 7 days.

Eligibility Criteria:
Inclusion Criteria:

1. Age 4-18 years old;
2. Clinically diagnosed by a psychiatrist with autism spectrum disorder;
3. Confirmed by researchers (pediatric psychiatrists) that they meet the diagnostic criteria for autism spectrum disorders in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) of the United States;
4. Evaluated by researchers (pediatric psychiatrists) using the Autism Diagnostic Interview Revised (ADI-R) and Autism Diagnostic Observation Schedule (ADOS), it is consistent with the diagnosis of autism spectrum disorders;
5. Capable of cooperating with magnetic resonance spectroscopy and transcranial direct current stimulation.

Exclusion Criteria:

* a) Existence of serious physical diseases and conditions, such as significant intracranial lesions, thyroid diseases, epilepsy, congenital heart disease, severe hematological diseases, systemic lupus erythematosus, visual and auditory impairments, etc;

  b) Imaging examination showed significant brain structural abnormalities;

  c) Having serious neurological diseases, a clear family history, or potential risks;

  d) Metal or pacemaker implantation in the body, holes or cracks in the skull;

  e) Taking benzodiazepines or anticonvulsants;

  f) The existence of clear or suspicious genetic diseases;

  g) Conforming to the diagnosis of other serious mental illnesses, such as schizophrenia and bipolar disorder.
A Pilot Study to Investigate Filiation Between Primary and Secondary Lesions in Acne Patients

Exploratory, international, multi-centre, randomized, investigator blinded study in acne


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 18 to 35 years inclusive
* Subjects with active, moderate acne

Exclusion Criteria:

* The subject has a secondary acne form (chloracne, drug-induced acne, etc.) (Screening)
* The subject has a severity of acne that is not amenable to treatment with CD0271-CD1579 (Screening)
Long-term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Mth Schedule in Healthy Adults

The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 11, 12, 13, 14 and 15 after subjects received their first dose of a 3 dose primary vaccination schedule of combined hepatitis A/hepatitis B vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

This protocol posting deals with objectives \& outcome measures of the extension phase at Year 11-15.

This is a long-term follow-up study at Years 11, 12, 13, 14 and 15 after primary vaccination with GSK Biologicals' hepatitis A/hepatitis B vaccine (three-dose schedule with 3 different lots). To evaluate the long-term antibody persistence, volunteers will be bled at Years 11, 12, 13, 14 and 15 after the first vaccine dose of the primary vaccination course to determine their anti-HAV and anti-HBs antibody concentrations.

No additional subjects will be recruited in the course of this extension study. If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 11, 12, 13, 14 or 15), he/ she will be offered an additional vaccine dose.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who had consented to participate in the long-term follow-up studies at the previous long-term blood sampling time points
* Written informed consent will have been obtained from each subject. before the blood sampling visit of each year.
The Impact of an Acute Bout of Exercise on Children's Eating Behaviors

The purpose of this project is to examine the effects of an acute bout of exercise on children's energy intake over the course of a day. Previous studies in adolescents and adults have shown exercise to be effective in decreasing short-term energy intake, with some variability. Individual characteristics such as habitual physical activity and psychological factors may influence the effect of exercise on energy intake, but these factors have yet to be examined. The investigators have assembled a multi-disciplinary team of researchers, with expertise in eating behavior, exercise, psychology, and clinical research in order to examine these questions. First, the investigators will examine the difference in energy intake at lunch, snack, and dinner meals in response to 30 minutes of imposed exercise compared to 30 minutes of rest. Second, the investigators will collect objective measures of children's habitual physical activity, child characteristics (body composition, eating behavior traits), and individual responses to the controlled exercise bout. The investigators can then examine both group and individual differences in the energy intake response to exercise. Children (ages 9-12) will be tested over the course of three visits. The key outcome will be differences in energy intake in response to exercise vs. rest. Secondary outcomes include the influence of differences in habitual physical activity, personal characteristics, and responses to the exercise bout on children's energy intake. The long term goal of this line of research is to understand the mechanisms behind the interaction between exercise and energy intake. The translational potential of this research will be to inform personalized childhood obesity prevention strategies in children at risk for overweight.


Eligibility Criteria:
Inclusion Criteria:

* English as a native language
* Reading at/above grade level
* Generally healthy
* Child is "normal weight" below the 85% age- and sex-specific BMI percentile
* Child has at least one biological parent classified as "overweight" or "obese" (≥ 25 kg/m\^2)
* Regularly eats breakfast

Exclusion Criteria:

* Contraindications to exercise testing (as defined by the American College of Sports Medicine)
* Medical conditions
* Psychiatric conditions
* Participation in competitive sports teams (year-round or more than 3 practices / week)
* Food allergies or other dietary restrictions
PPP-Botnia Exercise Intervention Study

The aim of the study is to evaluate the long-term effects of a prescription of exercise versus a group-based training program on aerobic fitness, muscle strength and metabolic variables in subjects with poor physical fitness. The participants are further stratified for a family-history of type 2 diabetes. The number of subjects in each group of intervention is planned to be 150, aged 30-70 years and non-diabetic.

Intervention: All study subjects take part in two individual sessions for exercise prescription aiming at moderate exercise of 30 minutes at least 5 days a week. The prescription group perform exercise by themselves, while the training group will be offered supervised physical training, including both endurance training and training in gym twice a week during 12 months.

The subjects will be followed up at 1, 2, 3 and 5 years after the basal visit.

Methods of follow-up: At the study visits physical fitness will be measured by a 2 km walking test, glucose tolerance by oral glucose tolerance test with measurement of glucose and insulin. Lipids will be measured. Questionnaires will be used to follow lifestyle, physical activity, cardiovascular disease and medication.

In the training group 30 subjects with and 30 subjects without a family history of type 2 diabetes will participate in a sub-study including muscle- and fat-biopsy before the start of the study, after 1 and 5 years.


Eligibility Criteria:
Inclusion Criteria:

* poor physical fitness based on repeated walking test (UKK 2 km walking test)
* non-diabetic

Exclusion Criteria:

* health problems complicating moderate physical training
Vorapaxar Study for Maturation of AV Fistulae for Hemodialysis Access

The Objectives of this study are:

1. To determine if vorapaxar safely improves arteriovenous (AV) fistula functional maturation when administered during the maturation process compared with placebo.
2. To determine if vorapaxar safely improves AV fistula patency, allowing for secondary procedures to aid in fistula maturation compared with placebo.
3. To determine if vorapaxar safely facilitates successful cannulation of AV fistulas for hemodialysis compared with placebo.

This is a randomized placebo-controlled double-blind pilot trial. Study procedures will be conducted at Stanford University Medical Center, and standard-of-care (SOC) procedures will be conducted at Stanford and it's affiliated hospitals (Veteran's Affairs Palo Alto Health Care System and the Stanford Vascular Surgery Clinic at Valley Medical Center). The investigators expect to enroll 128 patients. Patients will be assigned to treatment groups with a 1:1 randomization in blocks of 4 at the conclusion of the AV fistula creation. Patients will be stratified based on fistula location (lower arm versus upper arm).

Objectives:

1. To determine if vorapaxar safely improves arteriovenous (AV) fistula functional maturation when administered during the maturation process compared with placebo.
2. To determine if vorapaxar safely improves AV fistula patency, allowing for secondary procedures to aid in fistula maturation compared with placebo.
3. To determine if vorapaxar safely facilitates successful cannulation of AV fistulas for hemodialysis compared with placebo.

This is a randomized placebo-controlled double-blind pilot trial. Study procedures will be conducted at Stanford University Medical Center, and standard-of-care (SOC) procedures will be conducted at Stanford and it's affiliated hospitals (Veteran's Affairs Palo Alto Health Care System and the Stanford Vascular Surgery Clinic at Valley Medical Center). The investigators expect to enroll 128 patients. Patients will be assigned to treatment groups with a 1:1 randomization in blocks of 4 at the conclusion of the AV fistula creation. Patients will be stratified based on fistula location (lower arm versus upper arm).

Participation in this study will not affect standard care of patients with AV fistulae receiving hemodialysis. The only additional treatment is administration of the study drug or placebo and additional monitoring, including one additional ultrasound, for 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18
2. Receiving or planning to receive maintenance hemodialysis
3. Ability to sign informed consent
4. 3 mm venous diameter within recipient vein

Exclusion Criteria:

1. History of stroke, transient ischemic attack or intracranial hemorrhage
2. History of or high level of suspicion for, severe arterial insufficiency of the hand
3. Indication or ongoing therapy with other antiplatelet agents, other than aspirin 81 mg daily
4. Indication or ongoing therapy with anticoagulants, including warfarin, low molecular weight heparin, factor Xa inhibitors or direct thrombin and other inhibitors.
Characterization of the Iatrogenic Drug Risk in Elderly Patients With Chronic Pain Who Consult the Pain Assessment and Treatment Centre at the Nimes University Hospital

Chronic pain may be an additional risk factor for drug iatrogeny due to its management and also drug non-compliance in the geriatric population.

it seems interesting to carry out an inventory of the iatrogenic risk before and after the consultation at the pain centre to enable us to identify the patients most at risk. This study would make it possible to characterize elderly patients with chronic pain, in order to consider, in a future study, setting up a pharmaceutical consultation.


Eligibility Criteria:
Inclusion Criteria:

* The patient must be affiliated or beneficiary of a health insurance
* Patient ≥ 65 years old
* Having an outpatient consultation at the pain centre of the Nîmes University hospital of for chronic pain
* Available for pharmaceutical consultation about 30 minutes

Exclusion Criteria:

* It is impossible to give information
* The patient objects to participating in this study
Cure Rates of Superficial Basal Cell Carcinoma (BCC) EDC

This is a prospective, randomized clinical trial conducted at the Unviersity of Wisconsin (UW) Dermatology Clinic located at 1 S. Park Street, Madison, WI 53715. There are no controls. Subjects meeting eligibility criteria are randomly divided into one of two treatment groups (ED\&C x 1 cycle or ED\&C x 3 cycles) using computer generated random numbers. One cycle of ED\&C is defined according to standard technique currently employed. It involves scraping away the tumor with a curette (ring- shaped instrument) and then burning the curetted site with a small electric needle (electrodessication). During Visit 1, the surgical site is marked, local numbing medication is injected, and 1 or 3 cycles of ED\&C is/are performed by board-certified dermatologists or a dermatology resident under the direct supervision of a board certified dermatologist. All follow-up visits (3, 6, 9, and 12 months after Visit 1) include skin evaluations by the physician who performed the ED\&C. The lesion site is examined, measured, and photographed for clinical evidence of recurrence, as defined by a new lesion within the previously treated site. If there is evidence of possible tumor recurrence at the treated surgical site during Visit 2, 3, 4 or 5, then the lesion will be biopsied using a shave procedure.


Eligibility Criteria:
Inclusion Criteria:

* Untreated, biopsy proven superficial type basal cell carcinoma (BCC-S) on the trunk and/or extremities
* Age greater than 21
* Women with childbearing potential (including those who are pregnant/lactating)
* Able to provide written informed consent

Exclusion Criteria:

* Aggressive histology on initial biopsy (i.e. morpheaform, infiltrative, desmoplastic, or purely micronodular)
* Prior history of BCC or other skin cancer at the same location
* Lesion \> 2 cm
* Patients with basal cell nevus syndrome
* Transplant patients
* Immunocompromised patients
* Recurrent BCC
* Greater than 2 BCC-S on the trunk and/or extremities
* Prisoners
* Allergy to lidocaine or epinephrine
Assessing the Response Rate of Neo-adjuvant Taxotere and Trastuzumab in Nigerian Women With Breast Cancer

This is a one stage phase II study with a single arm design. It will be conducted in HER-2 positive breast cancer patients in Nigeria who are chemotherapy/hormonal treatment naive.


Eligibility Criteria:
Inclusion Criteria:

1. Women ages of 18 to 70 years old
2. Biopsy-accessible breast tumor of significant size for core needle biopsy/ultrasound measurable (≥ 2cm)
3. Patients with histologically confirmed carcinoma of the female breast with 3+ positive HER2 status by IHC
4. Clinical stages IIA -IIIC (AJCC 2009)
5. Chemotherapy-naïve patients (for this malignancy)
6. Performance status: ECOG performance status 0-1 (Appendix A)
7. Non-pregnant and not nursing. Women of childbearing potential must take the pregnancy test and must commit to receive LHRH agonist Zoladex (goserelin) for two years starting from the commencement of the study medications
8. Required Initial Laboratory Data. Adequate hematologic, renal and hepatic function, as defined by each of the following:

1. Granulocyte ≥ 1,500/μL 2. Platelet count ≥ 100,000/μL 3. Absolute neutrophil count (ANC) ≥ l500/μL 4. Hemoglobin ≥ 10g/dL 5. Bilirubin ≤ 1.5 x upper limit of normal 6. SGOT and SGPT \< 2.5 x upper limit of normal 7. Creatinine within institutional normal limits or glomerular filtration rate ≥ 30 mL/min/1.73 m2 by CKD EPI equation (see http://mdrd.com/ for calculator)

9. ECHO: Baseline left ventricular ejection fraction of ≥ 55%

Exclusion Criteria:

1. Pregnant or lactating women. Women of childbearing potential not using a reliable and appropriate contraceptive method. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Patients of childbearing potential will agree to continue the use of acceptable form of contraception for 24 months from the date of last Herceptin administration.
2. Patients with distant metastasis (brain and/or visceral metastasis)
3. Serious, uncontrolled, concurrent infection(s).
4. Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS)
5. Participation in any investigational drug study within 4 weeks preceding the start of study treatment
6. Other serious uncontrolled medical conditions that the investigator feels might compromise study participation including but not limited to chronic or active infection, HIV-positive patient, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled Diabetes mellitus, or psychiatric illness/social situations that would limit compliance with study requirements.
7. Patients with HER2-negative disease