cyrilzakka/clinical-trials huggingface dataset:
Bone-sparing Chemoradiotherapy for Anal Cancer - DACG-II

This study proposal includes a prospective clinical trial of bone sparing treatment planning in anal cancer patients. the trial aim to lower the risk of bone damage, while adhering with the constrains to the bowel, bladder and other conventional Organs At Risk, and finally to describe the fraction of pelvic insufficiency fractures in patients treated with optimized radiotherapy.

Patients will receive standard (chemo)-radiotherapy according to national Danish Anal Cancer Group (DACG) guidelines, but the bone-sparing focus will be added to the algorithm for dose-constrains and planning objectives. A bone specific magnetic resonance scan will be performed at 1 year post treatment. Additional substudies include collection of blood samples for translational research purposes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with biopsy verified localized squamous cell anal cancer
* Indication for standard (chemo)-radiotherapy with curative intend for anal cancer as per multidisciplinary team decision
* Clinical eligible for standard (chemo)-radiotherapy as per physicians' decision
* Written and oral consent
* Age at least 18 years

Exclusion Criteria:

* Previous pelvic radiotherapy
* Previous systemic therapy with severe bone marrow suppression or hematological diseases
* Hip-replacements
* Contraindications to MRI-scan
Pilot Test of Patient Decision Aid for Opioid Use Disorder

The aims of the current study phase (R21) are: Aim 1. Develop a patient decision aid (PtDA-MAT) by incorporating best available scientific evidence on MAT as well as feedback from patients and clinical providers related to clinical priorities, perceived utility, and acceptability; Aim 2. Conduct pilot testing of the PtDA-MAT in an iterative process guided by an expert panel and involving key stakeholders (e.g., patients, physicians, policymakers) and field-testing.

In response to RFA-DA-18-005 (Expanding Medication Assisted Treatment for Opioid Use Disorders in the Context of the SAMHSA Opioid STR Grants, R21/R33), this project will develop and test a patient decision support tool called Patient Decision Aid for Medication-Assisted Treatment (PtDA-MAT) for use in the CA H\&SS. The PtDA-MAT is designed to (1) improve patient knowledge and involvement and to subsequently improve treatment adherence and outcomes and (2) to support clinicians in informing and communicating with their patients with OUD along a continuum of care. The project will conduct 1 year of R21 to develop and pilot-test the PtDA-MAT to facilitate shared decision making in CA H\&SS, followed by 3 years of R33 to assess the effectiveness of the PtDA-MAT in a randomized controlled trial.

The aims of the current study phase (R21) are: Aim 1. Develop a patient decision aid (PtDA-MAT) by incorporating best available scientific evidence on MAT as well as feedback from patients and clinical providers related to clinical priorities, perceived utility, and acceptability; Aim 2. Conduct pilot testing of the PtDA-MAT in an iterative process guided by an expert panel and involving key stakeholders (e.g., patients, physicians, policymakers) and field-testing.

Eligibility Criteria:
Inclusion Criteria:

* Opioid Use Disorder diagnosis and agreement to follow study procedures (including permission to share medical records and other administrative records)

Exclusion Criteria:

* Significant or unstable medical or psychiatric illness that may interfere with study participation
A Retrospective Study of Real World Treatment Outcomes of Patients With Chronic Hepatitis C

This retrospective, observational study will assess the real world treatment out comes in the management of patients with chronic hepatitis C. No prospective ass essment or procedure with patients during this study will be conducted. Data wil l be collected from patient medical records of the year 2000-2011.


Eligibility Criteria:
Inclusion Criteria:

* Patients newly diagnosed with chronic hepatitis C during the year 2000 to 2010
* Availability of data for at least 6 months following the diagnosis date

Exclusion Criteria:

* Patients who participated in an investigational clinical trial
* Co-infection with hepatitis A, hepatitis B, hepatitis D, and/or human immunodeficiency virus (HIV)
* Patients with known severe medical conditions that are contraindicated to HCV treatment
Elucidating the Temporality of Structural and Functional Connectivity Changes in Essential Tremor After Successful Deep Brain Stimulation to the Dentato-rubro-thalamic Tract

The purpose of this study is to elucidate the structural connectivity of the dentato-rubro-thalamic tract (DRTt) and to detect functional network changes due to DRTt stimulation


Eligibility Criteria:
Inclusion Criteria:

* the diagnosis of Essential Tremor, made by a movement disorder neurologist, where tremor is not secondary to any disease process or traumatic insult
* distal appendicular tremor, with minimal proximal component
* tremor refractory to multiple medication regimens and/or where the medications cause intolerable side effects
* tremor judged to be severely impacting their quality of life.

Exclusion Criteria:

* significant neurological disorder
* significant dementia or neurocognitive limitations as assessed by neuropsychiatry (when necessary)
* severe psychiatric illness with suicidal ideations
* previous surgery to destroy the target region of the brain
* surgical contraindications to DBS
* current major medical problems that affect brain anatomy,neurochemistry, or function, e.g., liver insufficiency, kidney insufficiency, cardiovascular problems, systemic infections, cancer, hypothyroidism, auto-immune diseases, and any current of history of brain disorder (seizure disorder, stroke, dementia, meningitis, encephalitis, degenerative neurologic diseases and head injury with loss of consciousness for any period of time)
* family history of hereditary neurologic disorder, besides essential tremors ET
* floating metallic objects in the body
* pregnancy
* alcohol or substance abuse/dependence in the past 6 months.
Pulmonary Embolism as a Cause of COPD Exacerbations

The primary objective is to demonstrate the clinical benefits of an active strategy for the diagnosis and treatment of PE compared to usual care in patients with unexplained exacerbations of COPD who require hospital admission.

The secondary objective is to assess the safety of an active strategy for the diagnosis and treatment of PE compared to usual care in patients with unexplained exacerbations of COPD who require hospital admission.


Eligibility Criteria:
Inclusion Criteria:

* Confirmation of COPD according to SEPAR-ALT criteria: post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) \< 0.7;
* Hospital admission because COPD exacerbation without initial clinical suspicion of PE in the Emergency Department (according by the Emergency Department physician evaluation).

Exclusion Criteria:

* Contraindication to multidetector computed tomographic angiography (allergy to intravenous contrast medium, or renal failure defined as a creatinine clearance less than 30 mL/min, according to the Cockcroft-Gault formula)
* Informed consent denied
* Pregnancy
* Life expectancy less than 3 months
* Anticoagulant therapy at the time of hospital admission
* Diagnosis of pneumothorax, or pneumonia (fever, and purulent sputum, and new infiltrate in chest X-ray)
* Diagnosis of lower respiratory tract infection (fever \[\>37.8ºC\], increased sputum volume and/or increased sputum purulence).
* Indication of invasive mechanical ventilation at the time of hospital admission;
* Impossibility for follow-up.
Etoposide Plus Lobaplatin Versus Etoposide Plus Cisplatin for Patients With Limited Small-cell Lung Cancer

This randomized phase II study compare survival outcomes and toxicity of two chemotherapy regimens (etoposide plus lobaplatin or etoposide plus cisplatin) in combination with concurrent thoracic radiation therapy (TRT) for limited stage small cell lung cancer.

Lobaplatin is a platinum complex with DNA alkylating activity that was developed by ASTA Medica (Degussa) for the treatment of cancer. Lobaplatin as the third-generation platinum antineoplastic agent, showed promising antineoplastic effects in variety of preclinical test tumor models. A randomized, multicenter phase III study showed that Lobaplatin plus etoposide (EL) regimen is not inferiority to cisplatin plus etoposide (EP) regimen in terms of PFS, the tolerance and QOL with EL regimen are better than that with EP regimen. Thus, we perform this study was to compare the efficacy and safety of EL and EP regimens concurrently with thoracic radiotherapy in patients with limited-stage SCLC.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed SCLC
* Newly diagnosed SCLC
* Either sex, age between 18 to 75 years
* Limited stage: AJCC (8th edition) Stage I-III (T any, N any, M0) that can be safely treated with definitive radiation doses. Excludes T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan.
* Performance status ECOG grade 0-1. Patients with PS 2 whose general condition is explained by obstructive/bulky disease likely to improve after the first cycle of chemotherapy can be included at the discretion of the local investigator. Patients with PS 2 as a result of comorbid conditions will be excluded.
* Adequate bone marrow, liver and renal function as defined below:neutrophils ≥ 1.5 × 109/L, platelets 80 × 109/L, hemoglobin ≥80 g/L, AST and ALT ≤2× the upper limit of the institutional normal range, total bilirubin ≤1.25× the upper limit of the institutional normal range, and creatinine concentration ≤120 μmol/L
* No history of thoracic surgery, radiation therapy, or chemotherapy
* Had measurable or assessable disease

Exclusion Criteria:

* Pregnancy or lactation at the time of enrollment
* Previous malignancy or other concomitant malignant disease
* Malignant pleural or pericardial effusions
Evaluation of Tibial Nerve Selective Neurotomy Compared to Botulinum Toxin Injections for Spastic Foot Treatment in Post-stroke Patients According to a Goal-centered Approach

In France, more than 110.000 patients are hospitalized for stroke per year. It is the leading cause of sudden disabilities in adults. Incidence of spastic foot is evaluated at 1 year post stroke from 18% to 56% of hemiplegic patients. Spasticity, defined as an increase in the velocity-dependent response to muscle stretch measured at rest, is part of the upper motor neuron syndrome and is characterized by an increase in tonic stretch reflex. It has been proposed that upper motor neuro syndrome may induce not only spasticity but also other types of muscles overactivity such as spastic dystonia, co-contraction and clonus. In hemiplegic patients, lower limb spasticity within the posterior part of the leg frequently results in equino-varus foot and toes claw. These abnormal postures in hemiplegics may affect activities of daily living such as shoes fitting, balance, ambulation-walking, comfort (pain) and may become irreducible (tendon shortening) if not treated.

The purpose of this study is to compare the interest of each treatment (BoNT-A versus STN) in order to specify both techniques indications and up-date current guidelines of lower-limb spasticity for hemiplegic patients.

This study aims to confirm a greater reduction of calf muscles spasticity after STN as compared to BoNT-A, as observed in the only published monocentric randomized controlled trial. Our study originality is to perform a multi-center RCT with a pre-established sample size. This study will also quantify progress towards personal goals using the goal attainment scaling (GAS) and will assess other components related to the consequences of carve muscle spasticity on balance, ambulation, self-care and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (older than 18 years)
* Man and woman
* Hemiparesis secondary to stroke (delay from stroke \> 1 year)
* Foot with equinovarus with or without toe claw due to spasticity of at least the triceps surae and /or one of the following muscles: tibialis posterior, flexor digitorum and hallucis longus muscles.
* Spasticity confirmed with no isolated tendon shortening diagnosed using tibialis nerve block under local anesthesia with at least a 5 degrees gain in passive or active ankle dorsal flexion.
* Covered by National French insurance
* Able to understand French and the purpose of the study
* Informed consent signed by the patient or consent obtained from a relative or trusted person of the patient

Exclusion Criteria:

* Known sensitivity to BoNT or botulinum toxin A excipients
* Contraindication to surgery under general anesthesia
* History of myasthenia
* Pregnant woman (confirmed by urinary test) or breastfeeding
* Patient under legal protection
* Patients unable to follow the requirement of the study according to the investigator or supported by a family member
RECAP Multi-Component Intervention Program

This study evaluates the efficacy of the RECAP Mental Health + Academic Program for special education students in behavioral classrooms. The program includes multiple service components: the RECAP classroom mental health curriculum, which develops students' behavioral and social skills; reading intervention; individualized skills training; and parent group. Schools are randomly assigned to the treatment or control group. This two-year multi-component mental health and academic intervention is hypothesized to improve students' mental health, social skills, and academic functioning.

Background Information

This research project evaluates the efficacy of the RECAP Mental Health + Academic Program, a two-year multi-component intervention for special education students in behavioral classrooms. The program has been shown to reduce students' emotional and behavioral problems and remediate academic deficits, particularly with regard to reading skills, in order to enhance academic and behavioral functioning and to facilitate special education students' appropriate transition and reintegration into the mainstream educational setting.

Using an educational and instructional approach that is familiar to school staff and students, RECAP helps teachers and parents to assist children in the development of behavioral and emotional skills that facilitate children's ability to learn and to solve problems adaptively. Many of the techniques and strategies used in RECAP are familiar to teachers, as RECAP represents an integration of basic behavioral principles. Its unique strength lies in its consistent and integrated framework, which provides a common language for students, teachers, and parents to talk about behavioral expectations and positive skills for children to learn and apply in everyday situations. Moreover, the RECAP program focuses on helping students resolve the behavioral and emotional problems that interfere with their own learning as well as the learning of other students in the classroom (e.g., due to lost instructional time via classroom disruption). In addition to this mental health curriculum, the intervention includes a reading intervention component that has been shown to significantly improve the academic progress of students with emotional and behavioral problems. In addition to the obvious fundamental need for direct remediation of this academic skills deficit that is common among these students, the reading intervention is designed to prepare special education students to participate in the academic instruction of the general education classroom at a functionally adaptive level.

Participating schools are randomly assigned to either receive the RECAP program or serve as a comparison school (services as usual). Student outcomes will be evaluated in the fall and spring of two school years, using behavioral observation, academic testing, and teacher-, parent-, and child-reports of psychopathology and social skills.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in behavioral classroom

Exclusion Criteria:

* Lack of legal guardian to provide consent
Effect of Enhanced External Counterpulsation (EECP) on Subclinical Atherosclerosis

Shear stress maybe the most crucial local factor affecting atherogenesis. The present study investigated the effect of exposure to increased shear stress promoted by Enhanced External Counterpulsation (EECP) on the progression of subclinical atherosclerosis and the underlying inflammation- related molecular mechanisms

Hypercholesterolemic subjects with subclinical atherosclerosis will be randomized into two groups: standard treatment group and standard treatment plus EECP intervention group. The results of ultrasound examination and markers of inflammations will be compared.

Eligibility Criteria:
Inclusion Criteria:

* 20- 70 years old subjects whose LDL higher than 160mg/dl and carotid intima-media thickness higher than 75 percent of his age.

Exclusion Criteria:

* Presence of history of coronary heart disease, stroke or atherosclerotic peripheral disease. Presence of impaired renal function, connective disease, or infectious disease.
Navigating Insurance Coverage Expansion (NICE)

The purpose of this research is to measure the effectiveness of an in-person assistance intervention on successful insurance enrollment, types of insurance coverage, rates of linkage to and retention in HIV-related health care, referrals to other HIV-associated health services, and health outcomes. The study population is Black and Hispanic men who have sex with men (MSM) and transgender persons who are at higher risk for HIV.

The study team will be testing the hypotheses that in-person health insurance enrollment assistance results in positive outcomes with regard to linkage to and retention in HIV-related health care. Analyses will be used to assess the efficacy of the intervention as an emerging practice.

The overall goal of this study is to test whether providing in-person assistance in enrolling in private health insurance or Medicaid for the first time, changing to a different insurance plan, or understanding how to use current insurance policies following HIV testing will (1) increase the proportion of participants who obtain health insurance; (2) result in better health outcomes among participants; (3) improve the linkage and retention rates of participants, especially those diagnosed with HIV; and (4) increase linkage and retention rates sufficiently to justify the cost of implementing the intervention (cost-benefit analysis).

Eligibility Criteria:
Inclusion Criteria:

* Black or Hispanic men who have sex with men (MSM) or transgender persons
* 18 or older

Exclusion Criteria:

* Cisgender women
* Cisgender men who have not had anal or oral sex with a man in last 2 years
Study to Assess the Pharmacodynamics/Pharmacokinetics After Repeated Dosing of D961H 10 mg and Omeprazole 10 mg in Japanese Healthy Male Subjects

The purpose of this study is to assess the pharmacodynamics (intragastric pH) after repeated oral administration of D961H 10 mg and omeprazole 10 mg in Japanese healthy male subjects who are classified by the genotype of CYP2C19 by the assessment of percentage of time with intragastric pH\>4 during 24 hours after dose on day 5.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese male subjects between 20 and 45 years of age
* Genotype of CYP2C19 has been known as the volunteer panel data
* H. pylori negative has been known by urea breath test as the volunteer panel data.

Exclusion Criteria:

* Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention
* Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction
* Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention (eg, anesthetics used at the intragastric pH measurement)
Sucrosomal Iron Supplementation in Blood Donors

The aim of this descriptive/explorative pilot study is to examine the effects of supplementing a sucrosomal iron preparation in whole blood donors with iron deficiency for three months.

In this academic, monocentric interventional pilot study with one cohorte, otherwise healthy blood donors who have been rejected from blood donation due to low hemoglobin (females \<12.5 g/dl, males \<13.5 g/dl) and low ferritin levels (\<30 ng/ml) receive an iron-containing dietary supplement (sucrosomal iron) for three months with a daily intake of 30 g iron.

Fifty donors will be included in the study. The study population will consist of two sub-groups (premenopausal women and postmenopausal women plus men).

Our aim is to

* gain first findings concerning the extent of the change primarily in hemoglobin and secondly in ferritin concentrations
* observe acceptance and tolerance after intake of the test product for several months
* create pilot data for a following randomized controlled study.

In addition, possible clinical symptoms associated with iron deficiency will be recorded by using appropriate questionnaires (Questionnaire on the assessment of health-related quality of life \[WHOQOL-Bref\], Fatigue questionnaire \[FAQ\], questionnaire on psychic symptoms of insomnia \[RIS\] and Restless Legs Syndrome).

Eligibility Criteria:
Inclusion Criteria:

* Deferral from donation because of low capillary hemoglobin (Hb) \<12.5 g/dl (women) and Hb \<13 g/dl;
* Otherwise eligibility for donation according to medical history;
* Ferritin at the time of deferral \<30 ng/ml;
* Last whole blood donation \>2 months prior to current hemoglobin level;
* Written informed consent;
* Venous Hb \<12.5 g/dl (females) and \<13.5 g/dl (men);

Exclusion Criteria:

* Lack of legal capacity or court-appointed representation;
* Known pregnancy;
* Lactation period;
* Chronic diarrhea or known inclination for diarrhea;
* Known or suspected fructose intolerance;
* iron supplementation during the last three months;
* continuous or expected blood loss (capillary oozing);
* hypermenorrhea;
* planned surgical intervention with relevant blood loss within the next 3-4 months (duration of study);
* application of another iron supplementation during the next 3-4 months;
* intended application of preparations for a systematic increase of red blood cell and hemoglobin concentration or production (e.g. erythropoietin preparations, packed red blood cells) for the duration of the study;
* parallel participation in another clinical trial with insurance coverage;
* foreseeable compliance issues;
* foreseeable unavailability for the time of the final examination;
* Incompatibility with any of the ingredients of the product;
* Anemia requiring acute therapy: Hb \<8g/dl (as indication of an obligatory correction of the hemoglobin level to a clinically irrelevant or non-therapeutic value);