cyrilzakka/clinical-trials huggingface dataset:
Pilot Evaluation of a Healthy Lifestyle Intervention for Adolescent and Young Adult Survivors of Pediatric Cancer

This is a feasibility and acceptability trial to test a newly developed healthy lifestyle intervention for adolescent and young adult survivors of pediatric cancer.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be adolescents and young adults (15-25 years of age) who have completed cancer treatment at Johns Hopkins All Children's Hospital any time in the last five years. This age range was chosen because it corresponds to the recommended age range for cancer-related adolescents and young adult studies38.
* If the adolescent or young adult patient lives with a parent, other adult family member, or adult romantic/platonic partner, that person will also be invited to participate in the intervention as a support to the patient.
* If the adolescent or young adult patient lives with a parent or romantic partner, the parent or romantic partner will also be invited to participate in the intervention as a support to the patient. A parent or romantic partner is eligible to participate if the patient lives with them at least 50% of the time. The parent or romantic partner will not receive separate financial compensation for participation. Herein, we use the word "parent" only because we expect the vast majority of patients will live with a parent instead of a romantic partner. Patients who do not live with a parent or romantic partner will participate alone.
* The patient's cancer treatment must have included chemotherapy and/or radiation.
* If a patient's cancer relapses during the study period, the patient's oncologist must agree to the patient continuing in this intervention.

Exclusion Criteria:

* Potential participants who appear to have cognitive, motor, or language delays, as observed by research personnel or documented in the medical record, will be excluded from this study if delays preclude informed consent and/or study completion. Participants may request that research personnel read all assessment, education, and intervention materials aloud in a structured interview format, in which case participants could respond to items verbally and/or by pointing to visual aids. Because of this option, participants' ability to read and write are not requirements for participation.
* Because the motivational interviewing component of the intervention is language-dependent and requires significant time and training for certification in another language, non-English speaking patients will only be included in this study if the psychology postdoctoral fellow hired in this study is a native Spanish speaker and can demonstrate motivational interviewing proficiency in Spanish.
Detection of Cerebral Proteinopathy in Alzheimer's Disease Through Magnetic Resonance Imaging

The main goal of the T1rho/BBRC2017 study is to assess the capability of the MRI sequences T1rho + multicomponent T2 relaxation analysis of detecting abnormal cerebral protein deposition in AD patients in comparison with an age-matched cognitively healthy control group. Both the AD and control groups will had previously undergone amyloid PET imaging to confirm/discard cerebral proteinopathy in the context of other research studies.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years
* Informed, written consent form
* To fully satisfy the criteria for one of the two following 2 groups:

  1. for the AD group:

     * Diagnosed with AD as defined per the International Working Group IWG 2 criteria (fulfilling core clinical criteria plus positive core AD CSF biomarkers): Light to mild AD defined by Mini-Mental State Examination (MMSE) score between 15 and 27 (included).
     * Documented positive visual read (as per EMA-approved procedures for each respective tracer) of an amyloid PET scan, which in the opinion of the principal investigator is consistent with a diagnosis of AD in the last 24 months.
     * Lumbar puncture with core AD CSF biomarkers available in the last 24 months.
  2. For the cognitively health group:

     * Normal cognition as defined by the ALFA study cognitive workup (Molinuevo et al. 2016).

CONFIDENTIAL 17

* \[18F\]-Flutemetamol PET scan performed in the context of the PET FLUTEMETAMOL-FDG/BBRC2015 study in the last 24 months.
* Lumbar puncture with core AD CSF biomarkers preferably available in the last 24 months.

Exclusion Criteria:

* Past or present history of major brain disorders other than MCI or AD.
* Contraindication to MRI scanning or conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
* Participation in a clinical trial for a disease modifying drug for AD.
* Hypoperfusion pattern not consistent with AD diagnosis, as assessed by ASL.
Efficacy of Puressentiel Protective Nasal Spray in Allergic Rhinitis

This study is a proof o concept aiming to determine the efficacy of Puressentiel nasal protective spray (PNPS) in patients with allergic rhinitis.

Cross over study, with a nasal provocative test (NPT) in patients with allergic rhinitis sensitized to grass pollen. A day 0 (first NPT) the following outcomes are recorded: allergic Rhinitis control test (ARCT) and Inspiratory nasal peak flow (INPF) before and 30 min after the NPT. Nasal lavage is performed 30 min after the NPT and 3 cytokines (IL4, IL5 and IL13 are measured by ELISA.

An other NPT is performed at day 30 and the same outcomes measured.

30 min before NPT 2 nasal sprays of PNPS are administered in each nostril in a randomized manner and cross over, the patient being is own control.

The primary outcomes ins the IL4, IL5 and IL13 concentrations in the nasal lavage. ARCT and INPF are the secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

* patients with diagnostic of allergic rhinitis sensitized to grass pollen for more than one year with or without associated asthma

Exclusion Criteria:

* patients sensitized to a perrianual allergen
* patients with viral infection 4 weeks before inclusion
* patients with severe non controlled asthma
* patients with chronic sinusitis
* pregnancy or breast feeding
* patients with hypersensitivity to essential oil (eucalyptus radie)
* epileptic patient
* patients treated with nasal corticosteroid or anti-histamine
European Study in Bone Sarcoma Patients Over 40 Years

The study is a first step of a process to establish the standard chemotherapy treatment with the aim to improve outcome for patients with these rare tumours. For this reason the study will be non-controlled clinical trial.

In this regard, the study aims to determine the feasibility of intensive chemotherapy in this age group, and/or separate efficacy analyses according to the different histologic categories and whether the number of patients recruited by the co-operating groups permits future randomised studies.

Wide surgical removal of the tumor with the addition of a systemic treatment based on the antineoplastic drugs active against osteosarcoma (Adriamycin, Cisplatin, Ifosfamide, Methotrexate). The use of radiation therapy will be given to patients with unresectable tumors. It is recommended in patients who underwent inadequate surgical removal of the tumor. The addition of radiation therapy can not compensate for an adequate surgical treatment.

All the patients eligible for the study will receive the planned systemic treatment. Depending on clinical features, and feasibility of adequate surgical removal of the tumor, patients may receive primary chemotherapy followed by a postoperative chemotherapy treatment or only an adjuvant chemotherapy. In case of immediate surgery, patients will receive an adjuvant treatment with the 3-drug regimen (Cisplatin-Adriamycin-Ifosfamide).

Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven diagnosis of high-grade sarcoma of bone of any site.
2. Histologic types: osteosarcoma (high-grade surface, central primary and secondary), fibrosarcoma, malignant fibrous histiocytoma, leiomyosarcoma, dedifferentiated chondrosarcoma, angiosarcoma.
3. Age: 41 - 65
4. Normal bone marrow, hepatic, cardiac and renal function
5. Absence of contraindications to the use of cisplatin, adriamycin, and ifosfamide
6. Written informed consent

Exclusion Criteria:

1. Planned chemotherapy and/or follow-up not feasible
2. Previous chemotherapy treatment, which contraindicates the use of one or more drugs, included in the present protocol
3. Previous chemotherapy treatment for the current tumor
4. White blood count \< 3.0 x 109/L, and platelets \< 100 x 109/L
5. Creatinine clearance \< 70 ml/min
6. Left ventricular ejection fraction \< 55% or fractional shortening rate of the left ventricle \<28%
7. Serum transaminases and bilirubin \> 2 times the normal values
8. ECOG performance status \> 2
9. Chondrosarcoma or small/round cell bone sarcoma including mesenchymal chondrosarcoma and Ewing's family tumors.
Predictive Factors for Exacerbation Outcome in Severe Refractory Asthmatics

Asthma is a chronic inflammatory disease, affecting up to 10 % of the general population in developed countries. Corticosteroids are necessary to control symptoms, but induce adverse events sometimes intolerable. In severe asthma, which represent 5 to 10% of global asthma, corticosteroids frequently fail to prevent severe exacerbations, leading to emergency care, hospitalization and sometimes death. The aim of this study is to identify predictive factors specific for exacerbation outcome which will lead to a minor increase in treatment in order to prevent exacerbations, while minimizing drug adverse effects.


Eligibility Criteria:
Inclusion criteria :

* Male or female adults aged ≥ 18 years, who have signed an Inform Consent Form prior to initiation of any study-related procedure
* Patients with severe asthma with at least 2 exacerbations during the last 12 months that necessitated oral cortico-therapy or increase in oral cortico-therapy

Exclusion criteria :

* Pregnant or nursing women
* Patients with other chronic inflammatory lung disease
* Current smoker or a smoking history of 10 pack years or more
Social-Media Intervention in Reducing Tanning in High-Risk Tanners

This randomized clinical trial studies how well social-media intervention works in reducing tanning in high-risk indoor and outdoor tanners. Social-media intervention delivered via Facebook may help to promote healthy behaviors, positive body image, and to understand young women's perception of a social media campaign.

PRIMARY OBJECTIVES:

I. To conduct a randomized control trial to examine the efficacy of the intervention versus (vs.) a Facebook-delivered control group on reducing tanning behavior among high-risk indoor and outdoor tanners.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants periodically read the content on the study-specific secret Facebook group related to living a healthy lifestyle including avoiding tanning and excessive ultraviolet exposure, managing stress, healthy eating, promoting physically active lifestyles, and promoting a healthy body image, and participate in the group by providing reactions, commenting on the posts, or by sharing study relevant information within the group for 8 weeks.

GROUP II: Participants participate in secret Facebook groups that utilize content from the intervention content library related to other health topics of interest (e.g., physical activity, healthy eating, alcohol misuse prevention, stress reduction, sleep) for 8 weeks.

After completion of study, patients are followed up at 3, 8, and 18 months post baseline assessment.

Eligibility Criteria:
Inclusion Criteria:

* High-risk indoor or outdoor tanner (defined as using an indoor tanning bed or intentionally tanning outdoors at least 10 times in the previous 12 months)
* Use of Facebook at least 4 times per week
The Use of Prophylactic Antibiotics In the Management of Dog Bites

This double blinded RCT will help to ascertain the usefulness of prophylactic antibiotics in the management of uncomplicated dog bites, utilizing currently best available antibiotics (Augmentin) and an important clinical outcome of infection.

By enrolling 100-150 patients in this pilot trial as part of a k-award the investigators plan to utilize the point estimates of infection, side effects and other important outcomes and incorporate these into a cost most to determine the most cost effective management of these wounds and to determine if further study is warranted based on the findings.

This double blinded RCT will help to ascertain the usefulness of prophylactic antibiotics in the management of uncomplicated dog bites, utilizing currently best available antibiotics (Augmentin) and an important clinical outcome of infection.

By enrolling 100-150 patients in this pilot trial as part of a k-award the investigators plan to utilize the point estimates of infection, side effects and other important outcomes and incorporate these into a cost most to determine the most cost effective management of these wounds and to determine if further study is warranted based on the findings.

Eligibility Criteria:
Inclusion Criteria:

All patients including all children and English speaking/reading persons who present with a full thickness dog bite to participating emergency departments will be considered. Non-English speaking/reading subjects for whom we can provide translation for will also be considered.

Exclusion Criteria:

Exclusion Criteria:

* allergy to penicillin or amoxicillin/clavulanic acid
* wounds presenting with an active infection (require antibiotics) or greater than 12 hours old.
* patients with underlying fracture, joint or neurovascular injury, or multiple trauma requiring specialty referral. Specifically any broken skin over a joint will need treatment and be excluded from the study and randomization.
* patients on immunosuppressive agents, prolonged chronic steroid use (defined as continuous use for \> 14 days, 3 times a year) active HIV disease (determined by treating physician on history) or splenectomized. (could skew one group and at risk for overwhelming sepsis and death if infected)
* patients unwilling or unable to complete the required follow-up, and those unable to provide a contact phone number
Lentiviral (LV) Gene Therapy for Adenosine Deaminase (ADA) Deficiency

This is a historically controlled, non-randomized Phase I/II clinical trial to assess the safety and efficacy of autologous transplantation of CD34+ hematopoietic stem/progenitor cells (HSPCs), obtained from infants affected by ADA-SCID, following transduction of the HSPCs with a lentiviral vector (LV) carrying the human ADA complementary DNA (cDNA) under the control of the elongation factor 1 alpha shortened (EFS) promoter. Subjects treated in the trial receive the infusion of autologous, transduced cells following marrow cytoreduction with busulfan. The outcomes are compared to those observed in a historical control group of patients who received an allogeneic hematopoietic stem cell transplant (HSCT).

This Phase I/II clinical trial will be performed at Great Ormond Street Hospital (GOSH), London, United Kingdom.


Eligibility Criteria:
Gene Therapy (On Trial)

Inclusion Criteria:

1. Diagnosis of ADA-SCID confirmed by DNA sequencing or by confirmed absence of \<3% of ADA enzymatic activity in peripheral blood (or for neonates) in umbilical cord blood erythrocytes and/or leukocytes or in cultured fetal cells derived from either chorionic villus biopsy or amniocentesis, prior to institution of Polyethylene glycol-modified ADA (PEG-ADA) replacement therapy
2. Patients who lack a fully Human leukocyte antigen (HLA)-matched family donor
3. Patients (male or female) \<5 years of age OR Patients (male or female) ≥ 5 years to 15 years of age who have preserved thymic function as evidenced by presence of \>10 % naïve T cells (CD4+45RA+27+ cells)
4. Parental/guardian signed informed consent

Exclusion Criteria:

1. Cytogenetic abnormalities on peripheral blood
2. Evidence of active malignant disease
3. Known sensitivity to busulfan
4. If applicable, confirmed pregnancy (to be tested in patients above 12 years old)

Gene Therapy (CUP)

A group of patients were treated under CUP (GOSH special license) either because the study was not yet open and patients needed urgent treatment, or because they were outside of the inclusion/exclusion criteria or received Investigational Medicinal Product (IMP) followed a different process (ie, received in two infusions). Patients followed the same protocol steps and study visits.

Historical Control Group

Inclusion Criteria:

1. Diagnosis of ADA-SCID confirmed by DNA sequencing OR by confirmed absence of \<3% of ADA enzymatic activity in peripheral blood or (for neonates) in umbilical cord blood erythrocytes and/or leucocytes or in cultured foetal cells derived from either chorionic villus biopsy or amniocentesis, prior to institution of PEG-ADA replacement therapy
2. Patients (male or female) between 0-18 years at time of treatment
3. Patient treated with allogeneic haematopoietic stem cell transplantation since 2000
Primary Ceramic-on-Ceramic Total Hip Replacement Versus Metal-on-Metal Hip Resurfacing in Young Active Patients

Comparison of the functional result and speed of rehabilitation between two types of hip prostheses: primary ceramic-on-ceramic total hip replacement versus metal-on-metal hip resurfacing.


Eligibility Criteria:
Inclusion Criteria:

* Total hip replacement

Exclusion Criteria:

-
Relationship Between Isometric Muscle Strength and Gross Motor Function in Children With Unilateral Cerebral Palsy

Muscle strength can be defined as the ability of skeletal muscle to develop force for the purpose of providing stability and mobility within the musculoskeletal system, so that functional movement can take place.

Cerebral palsy describes a group of disorders of the development of movement and posture, causing activity limitation, that are attributed to non-progressive disturbances that occurred in the developing fatal or infant brain. The motor disorders of cerebral palsy are often accompanied by disturbances of sensation, cognition, communication, perception, and/or behaviour, and/or by a seizure disorder

The development and changes in motor function, both natural and with therapy, can be assessed using the Gross Motor Function Measure (GMFM) created for children with CP

Eligibility Criteria:
Inclusion Criteria:

1. Their age between 6 and 12 years old.
2. Grade 1and 2 according to the Modified Ashworth scale (RW and Smith, 1987).
3. They could walk with limitation or holding on according to GMFCS (level I, II) (Palisano et al., 1997).
4. They were able to understand and follow verbal instructions.

Exclusion Criteria:

1. Children with any visual or auditory problems.
2. Children with any surgical interference in the lower limb.
3. Children with any structural deformities in joints and bones of lower limbs.
4. Children with any special medications affecting muscle functions (anti-spastic drugs).
5. Children who suffer from other diseases or associated disorders that interfered with physical activity.
Antimicrobial Susceptibility Testing Guided Therapy Versus Empirical Therapy for the First-line Helicobacter Pylori Eradication.

The purpose of this study is to assess efficacy of 10-day antimicrobial susceptibility test guided triple therapy for the first-line treatment of Helicobacter pylori infection, then comparing it with 14-day empirical tailored therapy to tell which one has a better performance in both efficacy and safety.

Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathologies. Antimicrobial susceptibility test can pick out sensitive drugs to kill Helicobacter pylori, and reduce secondary drug resistance. But, there is a lack of high quality RCT to compare its efficacy with empirical regimen in the first-line treatment.

Our study aims to assess the efficacy of 10-day antimicrobial susceptibility test guided triple therapy for the first-line treatment of Helicobacter pylori infection. Comparing this regimen with 14-day Empirical Tailored Therapy to tell which one is better in clinic practice. We also want to find whether the 10-day antimicrobial susceptibility test guided triple therapy has less intestinal dysbacteriosis with a shorter duration.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-70 with H. pylori infection.

Exclusion Criteria:

* Patients with previous H. pylori eradication therapy;
* Patients unable or unwilling to receive gastroscopy;
* Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks;
* Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
* Patients with known or suspected allergy to study medications;
* Currently pregnant or lactating;
* Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
A Study of the Safety and Effects of ADH-1 Given Intravenously as a Single Agent

N-cadherin, a protein involved in blood vessel cell binding, is increased as cancer progresses, and is on the surface of many tumor cells. ADH-1 blocks N-cadherin. This study will test the safety and effects of ADH-1 in subjects with specific incurable, solid tumors with a protein biomarker called N-cadherin. This study will examine the clinical activity of ADH-1.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Male and female patients \> or = 18 years of age with a solid tumor(s) refractory to standard curative therapy or for which no curative therapy exists
* Histologically proven advanced and/or metastatic solid tumor of one of the following histologies:

  * non-small cell lung cancer (squamous or non-squamous histology),
  * gastroesophageal carcinoma (squamous or adenocarcinoma histology),
  * renal cell carcinoma,
  * hepatocellular carcinoma,
  * adrenocortical carcinoma
* Measurable disease
* Immunohistochemical evidence of N-cadherin expression (at least 1+ positive) in archived or fresh tumor tissue
* Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and electrocardiogram (ECG)

Exclusion Criteria:

* Receipt of ADH-1 prior to this clinical study
* Chemotherapy, radiotherapy, or any other investigational drug within 30 days before study entry
* History of spinal cord compression, or history of primary brain tumor(s) or brain metastases (known or suspected) unless any lesions have completely resolved following appropriate treatment and there has been no recurrence for at least 6 months
* History of tumors that have shown clinically significant evidence of active bleeding (e.g., gross hemoptysis, hematemesis, hematuria, melena, or bleeding superficial tumor) within 12 weeks before study entry
* Stroke, major surgery, or other major tissue injury within 30 days before study entry
* History of:

  * uncontrolled congestive heart failure,
  * coronary artery disease, or life threatening arrhythmias;
  * myocardial infarction less than 12 months prior to study entry;
  * significant ECG abnormalities; or
  * known hypercoagulable states