cyrilzakka/clinical-trials huggingface dataset:
DEFINITIVE AR Two Year Follow-up Extension Study

The purpose of this DEFINITIVE AR Two Year Follow-up Extension Study is to gather data to assess and estimate the long term effect of treating a vessel with plaque excision (PE) in combination with paclitaxel-coated balloon angioplasty (PTX PTA) compared to treatment with PTX PTA alone.


Eligibility Criteria:
Inclusion Criteria:

* Was a subject in DEFINITIVE AR I
* Is able and willing to provide written informated consent prior to study specific data collection.

Exclusion Criteria:

* Withdrew consent in DEFINITIVE AR I.
* Was reported dead during DEFINITIVE AR I.
Study of ONTAK in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)

The purpose of this study is to evaluate the safety and effectiveness of ONTAK in previously treated patients with chronic lymphocytic leukemia (CLL)


Eligibility Criteria:
Inclusion Criteria:

* Patients with B-cell Chronic Lymphocytic Leukemia, Rai Stage 0-II with indication for treatment by NCI Working Group Criteria or Rai Stage III or IV.
* Patients must have received at least one prior purine analogue-based chemotherapy regimen.
* ECOG Performance Status of 0, 1, or 2.
* Female patients cannot be pregnant and must use birth control during the course of the study and for three weeks after the study ends.

Exclusion Criteria:

* Prior treatment with ONTAK (DAB389IL-2) or DAB486IL-2.
* Received any therapy for CLL within 35 days prior to study entry.
A Study to Evaluate Renal Safety of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Disease Due to Breast Cancer

This study will evaluate renal function in participants with metastatic bone disease due to breast cancer receiving intravenous (IV) infusions of ibandronate (Bondronat) 6 milligrams (mg), over either 15 minutes or 60 minutes, every 3 weeks. Efficacy and safety of ibandronate in the 2 groups of participants will also be compared. The anticipated time on study treatment is 7 months, and the target sample size is 318 individuals.


Eligibility Criteria:
Inclusion Criteria:

* For participants of childbearing potential: negative pregnancy test and ready to use effective contraceptive measures
* Metastatic breast cancer with at least one bone metastasis
* Karnofsky index \>/= 60
* Life expectancy \>/= 6 months
* Estimated creatinine clearance (Cockcroft and Gault formula) \>/= 30 milliliters per minute (mL/min)

Exclusion Criteria:

* Pregnancy or breast feeding participant
* Participant who had a current dental problem, particularly tooth or jaw infection, trauma or surgery on tooth or jaw in the previous six weeks, medical history of jaw osteonecrosis or delayed healing after dental surgery
* Participant who was participating or had participated in the last 30 days to a clinical trial investigating treatments
* Uncontrolled brain metastasis
* Severe or concomitant infection
* Known medical history of systemic disease with renal lesion
* Rapidly progressing renal failure at inclusion
* Uncontrolled cardiac disorder
* Hypercalcaemia (\> 2.7 millimoles per liter \[mmol/L\]), hypocalcaemia (\< 2 mmol/L)
* Participant receiving nephrotoxic chemotherapy
* Participant eligible for haematopoietic stem cell transplantation at inclusion time
* Bisphosphonate therapy in the 3 weeks before randomization
* Known hypersensitivity to ibandronate or other bisphosphonates
Making Alcoholics Anonymous Easier

This study tests the effectiveness of Making Alcoholics Anonymous Easier (MAAEZ), a manual-guided intervention designed to help alcohol and drug dependent clients connect with individuals encountered in AA. An OFF/ON design was used (n=508). MAAEZ effectiveness was determined by comparing abstinence rates of participants recruited during ON (MAAEZ intervention) and OFF (usual care) conditions and by studying the effect of the number of MAAEZ sessions attended. Better outcomes were hypothesized for MAAEZ vs. usual care. At 12 months, more clients in the ON condition (vs. OFF) reported past 30-day abstinence from alcohol, drugs, and both alcohol and drugs. Abstinence increased for each additional MAAEZ session received. MAAEZ appeared especially effective for those with more prior AA exposure, severe psychiatric problems, and atheists/agnostics. Mechanisms of action for MAAEZ (mediators of the MAAEZ effect) include: doing service in AA/NA/CA; having a sponsor; having a social network supportive of abstinence; and comfort being in meetings. MAAEZ represents an evidence-based intervention that is easily implemented in existing treatment programs.


Eligibility Criteria:
Inclusion Criteria:

* current alcohol or drug dependence diagnosis

Exclusion Criteria:

* incapacitating mental or physical health; under age 18
Assessment of Anaemia Attributable to Schistosomiasis in School Children in Kenya: Mechanisms and Effect of Treatment

The purpose of this study is to determine the extend and the nature of anemia in school children and the correlation between anemia and schistosomiasis infections, malaria infections and/or malnutrition (iron deficiency).

The study will be carried out in an area around Lake Victoria in Kenya where the prevalence of schistosomiasis and malaria are highest in the areas nearest to the Lake. Depending on the prevalence of schistosomiasis a sample of between 876 to 2.524 children will be enrolled in the study. The children who will be in the age between 9 to 12 year, will have their stool and urine examined for schistosomiasis and intestinal worms and a blood sample will be examined for malaria parasites and the hemoglobin level. Children will also be weight, measured and examined by a doctor and register their food intake over one week, to determine their nutritional status. Children who are found to be infected with schistosomiasis, intestinal worms or malaria will be offered treatment. Children who are found to have anemia will be offered a course of iron supplementation, children with severe anemia will be referred to the nearest health facility for treatment. 12 months after the initial examinations and treatment all children will have a re-examination of their stool, urine and blood.

Eligibility Criteria:
Inclusion Criteria:

* school children between 9 to 12 year
Sleep Hygiene and Relaxation Intervention to Improve Sleep and Fatigue for Children Receiving Maintenance Chemotherapy

This pilot randomized controlled trial examined the feasibility, acceptability and effectiveness of an intervention to improve sleep quality and decrease fatigue levels in children with a diagnosis of ALL, during maintenance treatment. Families were randomized to usual care or the intervention. The intervention included a sleep hygiene and relaxation education session with a nurse practitioner, literature for home, two story books, and a follow-up phone call. Self-reported measures were used in addition to actigraphy to measure children's quality and quantity of sleep.

Sleep is an essential restorative function that promotes both physical and cognitive health. Previous studies have demonstrated that children on Acute Lymphoblastic Leukemia (ALL) maintenance therapy have problematic sleep patterns and experience fatigue. This pilot randomized controlled trial examined the feasibility, acceptability and effectiveness of an intervention to improve sleep quality and decrease fatigue levels in children aged 4-10, with a diagnosis of ALL, during maintenance treatment. Families were randomized to usual care or the intervention. The intervention included a sleep hygiene and relaxation education session with a nurse practitioner, literature for home, two story books, and a follow-up phone call. Self-reported measures were used in addition to actigraphy to measure children's quality and quantity of sleep. Sleep tips were evaluated by intervention group families.

Eligibility Criteria:
Inclusion Criteria:

* Child aged 4-10 with a diagnosis of precursor acute B lymphoblastic leukemia (B ALL) in maintenance phase of therapy beyond 3rd course (protocol AALL0331)
* Child and parent able to understand and read English
* Child is within one year of age-appropriate grade in school

Exclusion Criteria:

* Child who is receiving palliative care
* Child with diagnosis of depression
* Child who has been prescribed medications for insomnia
* Child who has a physician-diagnosed sleep disorder (e.g. narcolepsy, restless legs syndrome)
* Child who has received radiation therapy
* Child has potential sleep disordered breathing (measured by Children's Sleep Habits Questionnaire)
Effect of Vegan Diet and Lifestyle Changes on Indolent Lymphoma During Controlled Waiting Period

The aim of the present trial is to evaluate the effect of lifestyle changes on the natural history of indolent lymphomas, during the period of watchful waiting. The intervention program is comprised of specifically designed vegan nutrition, physical activity, mostly aerobic, and stress reduction by relaxation and meditation. Outcome results will be followed and analyzed for 3 years, taking into consideration the following parameters - disease burden, specific disease-related symptoms, relevant blood tests, body weight, indicators of well-being. Changes in these parameters will be correlated with the level of compliance and adherence to the intervention program. The results of the trial group of patients will be further compared to the natural history of the disease in a comparable group of patients during their waiting period who were not subject to the above intervention.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Patient sex - male and female
* Diagnosis with indolent lymphoma in low-grade lymphoma (follicular lymphoma (FL), marginal zone lymphoma MZL), as assessed by Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria
* Lack of need and non treatable patients at the time of diagnosis
* Existence of detailed medical information about physical activity and dietary habits
* Patients who have signed an informed consent form to participate in the study.

Exclusion Criteria:

* Need for therapeutic intervention
* Administration of chemotherapy and / or monoclonal antibodies or immunomodulatory preparation
* Chronic inflammatory or infectious disease
* Another malignant disease
* Pregnant women, special populations - children and incapacitated of judgment
Dopaminergic Loss and Pain in Parkinson's Disease

About 46% of patients suffering from Parkinson's disease present pain disorders. Parkinson disease is characterized by loss of dopaminergic neurons. The aim of this study is to assess the relationship between the loss of dopaminergic neurons and the existence of pain in Parkinson's disease. Using single photon emission computerized tomography (SPECT) imaging (123I FP-CIT, which binds dopamine transporter) and the determination of subjective pain threshold, the investigators will establish correlations between dopaminergic degeneration and pain perception.

Parkinson's disease is a frequent neurodegenerative disease leading to motor handicap, cognitive and pain disorders. These pain disorders could be correlated to dopaminergic loss.

The clinical trial will be conducted in a single center (Neurology Department, Purpan Hospital, Toulouse, France). The study is classified as a physiopathology one. Twenty patients with Parkinson's disease, presenting pain disorders or not, will be selected. This clinical trial will last one year. All the exams, including image acquisition will be done the same day. These will take about 6 hours for each patient.

Expected results: Binding of 123I FP-CIT to dopamine transporters should negatively correlate with pain intensity and also with thermal pain thresholds in patients suffering from Parkinson's disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically established Parkinson's disease according to the UKPDSBB (UK Parkinson's Disease Society Brain Bank) (Gibb et Less, 1998; Hugues et al, 1992).
* Male or Female patients, aged from 30 to 70 years.
* Patients must benefit from the French Social security system.
* Patients must give a written informed consent.
* Female fertile patients must use an efficient method of contraception.

If patients suffer from chronic pain, pain must be related to Parkinson's disease.

Exclusion Criteria:

* Patients with a syndrome other than the idiopathic Parkinson's disease.
* Patients suffering from important trembling during the OFF periods or abnormal involuntary movements (dyskinesia) during the ON periods, not allowing the imagery exam to be performed.
* Patients suffering from another disease causing chronic pain.
* Patients suffering from cancer.
* Patients with cognitive dysfunction.
* Patients not able to complete the scales.
* Pregnant, breastfeeding or fertile female patients not using an efficient method of contraception.
* Patients not willing to participle in the trial.
Patient and Caregiver Psychological Functioning Following Neuro-ICU Admission: A Prospective Investigation

The current study has the following objectives:

1. To determine predictors of time 2 and 3 (3 and 6 months post-ICU admission) depression, PTSD, satisfaction with life and quality of life in both patients and caregivers, after controlling for injury severity and impairment.
2. To determine factors associated with patient and caregiver satisfaction with medical care at time 2 and time 3.

The investigators would thus be able to identify the best time point for intervention delivery, intervention targets, and risk factors for chronic psychological distress.


Eligibility Criteria:
Inclusion criteria for patients:

1. 18 years of age and older
2. English fluency and literacy
3. Admitted to the Neuro-ICU

Inclusion criteria for family caregivers:

1. 18 years of age and older
2. English fluency and literacy
3. Family member of patient who is identified by patient as the primary caregiver

Exclusion criteria:

1. Patients who cannot complete questionnaires due to their medical condition, and are anticipated to not be able to complete questionnaires at any of the future time points, due to permanent impairment.
2. Patients who lack decision-making capacity as determined by their clinical team
3. Patients who are comfort measures only (CMO)
Cognitive Effects of Atomoxetine in Humans: Genetic Moderators

The overall goal of this study is to determine if atomoxetine treatment improves selective cognitive functions in abstinent cocaine users, compared to healthy controls. The study will also test if a functional variation of the NET promoter polymorphic region (NETpPR) moderates the cognitive effects of atomoxetine.

This will be a double-blind, placebo-controlled, crossover study, with cocaine use (cocaine users vs. healthy controls) and NET AAGG4 status (L4/ L4 vs. L4/S4 or S4/ S4 genotype) as the between-subject factors. Similar to previous studies, we propose to compare individuals with two copies of the L4 allele to participants with at least one S4 allele because only less than two percent of the general population is homozygous for the S4 allele. Forty cocaine users and 40 healthy controls will participate in 3 test sessions, where they will be assigned to 40 mg atomoxetine, 80 mg atomoxetine, or placebo. Outcome measures will include physiological, subjective, and cognitive performance measures.

To date this study has 35 completers and currently in data analysis. (January 2016)

Eligibility Criteria:
Inclusion Criteria:

* Male and females, between the ages of 21 and 50;
* No current dependence or abuse of drugs of abuse or alcohol (except and tobacco);
* No current medical problems and normal ECG;
* For women, not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods.

Exclusion Criteria:

* Current major psychiatric illnesses including mood, psychotic, or anxiety disorders;
* History of major medical illnesses; including liver diseases, heart disease, or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study;
* Known allergy to Atomoxetine;
* Use of Monoamine Oxidase inhibitor within the last month (clinically Atomoxetine administration is contraindicated with or within 2 weeks of discontinuation of Monoamine oxidase inhibitor therapy).
Influence of Airway Clearance Techniques on GOR in Infants

The purpose of this study is to determine whether Assisted Autogenic Drainage (AAD) or bouncing combined with Assisted Autogenic Drainage (BAAD), induces or aggravates acid and non-acid gastro-oesophageal reflux in infants under the age of one year. Infants, referred to the hospital for impedance-pH monitoring are included in this study.


Eligibility Criteria:
Inclusion Criteria:

* Each child under the age of 1 year, referred for 24 h impedance monitoring to confirm a clinically suspected diagnosis of pathological GOR will be included

Exclusion Criteria:

* prematurity (gestational age less than 37 weeks),
* the use of anti-reflux medication and reflux surgery (Nissen fundoplication)
A Study of RO7123520 to Evaluate the Safety and Efficacy in Participants With Moderately To Severely Active Rheumatoid Arthritis (RA) Who Are Inadequately Responding to Anti-Tumor Necrosis Factor (TNF)-Alpha Therapy

This is a Phase IIa/b double-blind, placebo-controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of RO7123520 as adjunctive therapy in participants with RA who are inadequately responding to standard-of-care (methotrexate and anti-TNF-alpha therapy). Part 1 of the study will evaluate safety. Part 2 will evaluate efficacy and safety. Part 3 will evaluate dose-ranging efficacy. Participants will have the option of continuing to the extension period of the study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of adult-onset RA as defined by the ACR 2010 criteria, for at least 6 months before screening
* Moderately to severely active RA as defined by at least 4/28 tender joints and at least 4/28 swollen joints, and a DAS28 greater than or equal to (≥) 3.2
* For Part 2 only: Active synovitis and/or osteitis as determined by contrast-enhanced magnetic resonance imaging
* Participants must be taking stable dose of anti-TNF-alpha therapies
* Participants on stable oral glucocorticoids within 6 weeks of planned randomization
* Participants taking non-steroidal anti-inflammatory drugs (NSAIDs) intermittently (up to 2-3 times weekly) for short-term relief of pain and participants on regular NSAID use (on stable dose for ≥ 4 weeks)

Exclusion Criteria:

* Parenteral glucocorticoids administration (intramuscular, IV) of ≥50 mg within 6 weeks or less than or equal to (≤) 50 milligrams (mg) within 4 weeks prior to planned randomization, or scheduled parenteral administrations during the study
* Joint(s) injected with intra-articular glucocorticoids or hyaluronic acid within 6 weeks prior to planned randomization
* Active inflammatory diseases of the joints not related to RA
* Systemic autoimmune disease other than RA
* Juvenile idiopathic arthritis or juvenile RA and/or RA developed before the age of 16
* Active fibromyalgia that makes appropriate assessment of RA disease activity challenging in the opinion of the Investigator
* RA participants functional status class IV according to the ACR 1991 criteria
* Participants with severe chronic or recurrent viral, bacterial, parasitic, or fungal infections
* History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection
* Any identified confirmed congenital or acquired immunodeficiency
* Abnormal laboratory values and liver function test
* Myocardial infarction within less than 6 months prior to participation in the study
* Severe central or peripheral nervous system diseases
Insoles Adapted in Flip-flop Sandals in People With Heel Pain

Introduction: Persistent hindfoot pains are very common and prevalent complaints in the Brazilian population. One of the treatments recommended for these conditions in the literature is the use of insoles. However, to use this resource it is necessary that the individual wear closed shoes and this is an obstacle to treatment in cities with hot climate. Thinking about an alternative treatment, the customized slippers with the corrective elements of the insoles can be an alternative to increase adherence to this type of treatment. Objective: To compare different types of hindfoot elements in insoles adapted in slippers in individuals with persistent hindfoot pain.

Methodology: This is a protocol for a controlled, randomized, blinded clinical trial. Eighty participants with persistent hindfoot pain will be evaluated and randomized into two intervention groups: insoles adapted to flip-flops and flip-flops with sham insole. The evaluations will be carried out at baseline (T0), after six (T6) and twelve weeks (T12) of the use of flip-flops, in addition to the follow-up that will be carried out four weeks after the end of the intervention (T16). The primary outcome will be pain, using the Numerical Pain Scale and the secondary outcomes will be: foot function, using the Foot Function Index questionnaire, functional capacity in walking, using the Six-Minute Walk Test and pain catastrophizing using the Scale. of Pain Catastrophizing. Statistical analysis: Data will be analyzed by T-student, Mann-Whitney and repeated measures ANOVA tests and will be analyzed by intention to treat. Ethics and disclosure: This protocol was approved by the Ethics Committee of UFRN/FACISA (number 4,018,821). The results of the study will be disseminated to participants and submitted to a peer-reviewed journal and scientific meetings.

Eligibility Criteria:
Inclusion Criteria:

* Individuals of both sexes, aged 18 to 65 years;
* Persistent heel pain for at least three months based on self-reported criteria: heel pain accompanying the first steps in the morning, after a period of inactivity, and/or during prolonged weight-bearing;
* Pain intensity between 3 and 8 points, according to the Numerical Rating Scale (NRS) \[22\];
* Individuals who can wear flip-flop sandals for at least four hours per day for 12 weeks.

Exclusion Criteria:

* Clinical diagnosis of neuropathic pain or neurodegenerative disorders, persistent heel pain due to rheumatic conditions, and previous ankle and foot surgeries;
* Physical therapy treatment in the last three months;
* Corticosteroid injection into feet in the last six months;
* inability to answer study-related questionnaires;
* Individuals scheduled to travel in the next six months.
The Effects of Mannose Supplementation on Glycosylation and Protein Levels in Human Sera

The purpose of our study is to investigate the effects of supplemental mannose on sera of humans who are healthy. We will perform proteomics studies to elucidate changes to glycan structure and protein level changes. We hypothesize that we may find that mannose supplies more properly glycosylated protein substrate and helps expedite protein synthesis, that excess mannose leads to alternative glycan structures which confer improved stability, or that there are new sites that become glycosylated after mannose supplementation.

Subjects will be enrolled and a baseline blood sample taken. Subjects will take mannose supplements for 1 week (3-4 packets of a standard dose in water), then a follow up blood sample will be taken.

Subject blood will be analyzed by proteomic analysis for 1) change in glycan structure or 2) other protein based approaches to measure changes in levels of proteins.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* No known medical conditions
* Taking no medications or nutritional supplements
* Agree to the study and provide informed consent

Exclusion Criteria:

* Less than 18 years of age
* Known medical diagnosis, including pregnancy
* Presently taking medications and/or nutritional supplements
* Do not provide consent