cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Using an Oil Bath Additive

Epidermis that lacks moisture and/or sebum presents as dry skin, which is often characterized by a pattern of fine lines, scaling and itching. In dry skin, the barrier function may be compromised. Skin care practices to decrease the risk of development of dry skin and/or to improve dry skin condition have barely been investigated. Bathing with bath oils has been shown to increase skin hydration, thus helping to stabilize skin barrier function. Therefore, the aim of this study is to investigate the effect of bathing every other day on the skin barrier. Functional parameters, such as TEWL, stratum corneum hydration (SCH) and skin-pH (pH) were measured to characterize skin barrier function.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent, or children whose parent(s) or guardian(s) have given their written informed consent for their child's participation in the study
* Child specific written informed consent, if over 7 years of age
* Subjects with a general good and stable health condition
* Subjects with clinically stable medical conditions
* Accept to abstain from sunbathing and solarium during the study
* Overall Dry Skin score (ODS) of 1 to 2 at arms and lower legs
* TEWL \> 12 g/m2/h on the left mid volar forearm

Exclusion Criteria:

* Any dermatological condition or skin affection which may interfere with the study assessments, e.g. scars
* Suffering from porphyria
* Suffering from severe photodermatoses according to the judgment of the investigator
* Clinically significant, possibly unstable medical conditions such as metastatic tumor
* Currently having other malignant or benign tumors of the skin in the investigational area
* Any other acute or chronic pathology that may interfere with the study conduct in the investigator's opinion
* Known allergy or intolerance to any ingredients of the study product, e.g. propylene glycol
* Use of (medical) oil-containing bath additives or other oil-containing cleansers
* Current topical or systemic treatment affecting the skin, e.g. diuretics
* Treatment of dry and/or inflammatory skin conditions with topical corticosteroids during the 4 weeks before inclusion
* Systemic immunosuppressive or immunomodulatory therapy
* Topical retinoids applied during the 6 weeks before inclusion
* Topical application of immunosuppressive treatment during the 6 weeks before inclusion
* Therapeutic UV-Radiation during the 6 weeks before inclusion
* Increased UV-exposure during the 6 weeks before inclusion
Esophagectomy in Patients With Liver Cirrhosis

Retrospective and confounder adjusted comparison of perioperative and longterm outcomes of patients requiring an esophagectomy for esophageal cancer with and without concomitant liver cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* primary esophageal cancer with indication for curative treatment
* follow up period ≥ 5 years
* LC cohort: pre- or intraoperative histological proof of liver cirrhosis

Exclusion Criteria:

* recurrent esophageal cancer
* missing indication for curative treatment of esophageal cancer
* esophagectomy for benign esophageal lesions
Evaluation of the Auryzon Devices in the Optimization of Ear and Nose Reconstruction Procedures

This study evaluates the efficacy of the AuryzoN devices in the ear and nose reconstruction surgeries, both in terms of operative time and overall quality of reconstruction. Research participants will undergo reconstruction either using the AuryzoN device or through current methods (traditional manual processing) at the discretion of their surgeon prior to the start of surgery.

The AuryzoN devices are a family of two (2) devices that, in conjunction, serve to process substrates of autologous-derived or cadaveric cartilage used in the reconstruction of various structures of the body, namely ear and nose. The devices are to be used in the operating room to cut and carve substrates of tissue into components, which are then assembled into the final ear or nose, that will then be implanted by the plastic surgeon into the appropriate area. This device family serves to replace the current step in this reconstructive procedure, which involves the time-consuming and error-prone process of manual cartilage processing.

Participants will be given the option to participate in the study. If the participants so choose, they will undergo ear or nose reconstruction using the AuryzoN devices or traditional manual processing at the discretion of their surgeon prior to the start of surgery. The following outcome measures will be measured: operative time, error rates, objective quality outcomes of reconstruction, subjective quality outcomes of reconstruction, and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 1-100 of sufficient health required to undergo ear/nose reconstruction under general anesthesia
* Pre-existing physical deformity of the ear, nose, or eyelid necessitating surgical reconstruction
* Sufficient autologous or cadaveric rib cartilage for use by the AuryzoN system for cartilage processing

Exclusion Criteria:

* Patients with ear/nose/eyelid deformities not requiring surgical correction
* Patients without sufficient rib cartilage for use by the AuryzoN system and those who do not desire cadaveric cartilage use
* Patients in poor health to undergo surgery under general anesthesia
* Patients whose desired ear/nose/eyelid exceeds the dimensions/shapes of those pre-fabricated blades used in the AuryzoN system
Characterisation of Clinical Phenotypes and Outcomes of Ma2 Patient

Paraneoplastic neurological syndromes (PNS) are rare complications of cancer occurring in 0.01% of cases. Their clinical, biological and radiological presentation is heterogeneous and may constitute a diagnostic challenge. Anti-Ma2 PNS are rare diseases with a guarded prognosis. They are most often associated with a seminoma-like testicular tumor but can also be associated with lung cancer. Classically, they present as limbic, diencephalic and/or brainstem encephalitis. Anti-Ma2 antibodies target intracellular receptors and are characteristic of a particular form of encephalitis. Atypical manifestations including narcolepsy-cataplexy, weight gain, sexual dysfunction and motor neuron syndrome have been described and explain the difficulty in diagnosing anti-Ma2 associated PNS. It seems interesting to better characterize the phenotypes of Ma2 patients in order to optimize the diagnosis and follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Neurological disorder
* Anti-Ma2 positivity in sera or CSF
* Patient \> 18 years old

Exclusion Criteria:

* Patient without clinical data
* Patient without Ma2 antibody in sera or CSF
The Effect of Early WBVT on Neuromuscular Control After ACLR

To investigate the effect of early WBVT on neuromuscular control after ACLR.

The knee joint position sense, postural control, muscular strength and functional ability after anterior cruciate ligament construction (ACLR) are distorted, and even after a period of rehabilitation.

Previous studies had demonstrated that there was improvement in knee joint, postural balance, muscle strength and functional outcome in elderly, stroke and spastic patients already. It has also been concluded that the balance in elderly, postmenopausal women, Parkinson's disease, multiple sclerosis, stroke and spastic patients were all significantly improved. Some studies showed that the proprioception in osteoarthritis patients significantly improve. Knee strength is also one of the aspect being improved.

However, no studies focus on the early effect of WBVT on knee joint proprioception, postural control, muscle strength, knee joint stability and functional ability in ACLR cases. This study is to answer this research gap.

Eligibility Criteria:
Inclusion Criteria:

* ACLR with a single-bundle approach
* no complication such as wound infection after the ACLR
* able to walk with a pair of elbow crutches independently at one month post operation

Exclusion Criteria:

* concomitant posterior cruciate ligament, lateral collateral ligament, and medial collateral ligament injury in the same knee
* previous operation on either lower limbs
* medical problems such as pregnancy, acute thrombosis, serious cardiovascular disease, pacemaker, acute hernia, discopathy, spondylolysis, severe diabetes, epilepsy, recent infections, severe migraine, tumors or kidney stones etc
* neurological conditions such as Guillain-Barre ́ syndrome, myasthenia gravis, and postpolio syndrome
* prior experience of WBVT
New Adjuvant Chemotherapy of Asymptomatic Resectable Primary Lesion With Unresectable Liver-limited Metastases

To evaluate the survival benefit of pre-operation chemotherapy of primary tumor tesection (PTR) compared upfront PTR for colorectal cancer (CRC) patients with an asymptomatic resectable primary tumor and synchronous unresectable liver-limited metastases with conversion therapy intent.

Fast recovery with fewer postoperative complications, prevention of potential tumor-related complications during chemotherapy, life quality improvement, and also can alleviate the tumor load of patients, are some advantages of PTR that may play a role in improving cancer-specific survival. However, it should be pointed out that nearly all the retrospective and prospective studies for the beneficial of PTR enrolled more multi-organ metastases mCRC patients, and with palliative treatment purpose. As for unresectable colorectal liver-limited metastases (CRLMs) with good Eastern Cooperative Oncology Group performance status (ECOG PS), the primary objective is to make metastases resectable by high-intensity conversion therapy and achieved a state of no-evidence of disease. PTR were preferred performed before enrollment in some related RCT studies, including the CELIM study, CAIRO and CAIRO2 studies. Pooled-analysis of our two RCT studies, PTR pre or post chemotherapy for these unresectable liver-limited metastases patients had less morbidities and no mortalities, but no RCTs have focused on survival benefit of pre-operation chemotherapy of PTR for unresectable CRLMs.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 - 75 years old
* colorectal adenocarcinoma pathologically
* without any chemotherapy or radiotherapy
* unresectable liver metastasis and without other metastasis
* resectable colorectal cancer
* suitable for chemotherapy
* agreed by patients

Exclusion Criteria:

* age below 18 years old or greater than 75 years old
* haven't pathological diagnosis of colorectal adenocarcinoma
* with any chemotherapy or radiotherapy
* resectable liver metastasis or without other metastasis
* unresectable colorectal cancer
* unsuitable for chemotherapy
* not agreed by patients
Impact of Spectacles on Compliance to Mask-wearing Directives

Primary objective of this study is to identify the compliance of Greek people in mask-wearing directive and explore potential associations with refractive errors, spectacles and contact lenses use.

Present study aims to identify whether Greek people have complied with mask-wearing directive and to investigate the correlation of outcomes with visual acuity - refractive errors, spectacles and contact lenses use. For the purposes of this research, a questionnaire of 20 items including the following sub scales have been developed: a) near vision, b) distance vision, c) ocular discomfort, d) driving, e) limitations, need for help, work collaboration, and emotional impact

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* Adequate literacy of Greek language
* Permanent residence in Greece

Exclusion Criteria:

* Poor knowledge of Greek language
Novel Measure of Social Deficits in Children

Autism Spectrum Disorders (ASD) feature impairments in social interaction and communication. Drug and behavioral treatments for ASD are undergoing rapid development, yet our diagnostic tools are not suitable for efficacy assessment. The Autism-Diagnosis Observational Schedule (ADOS) is a clinical interview with the child and the gold standard for diagnosis. However, this test is subjective, course grained and costly, precluding repeated tests of the same child to assess treatment efficacy and large-scale control assessments of typically developing (TD) children. For these reasons, the ADOS can impede imaging and genetic research.

In light of these concerns, the Oregon Animation Test for Social Reciprocity (OATS) will be developed to evaluate distinct autistic behavioral phenotypes, including joint attention, empathy, imitation, and lack of narrative coherence. The main idea of OATS is that animated characters and social scenarios are presented on a computer screen while the responses of the child are recorded by video camera, microphone, and eye-tracking equipment. Animations are used to test each behavioral phenotype of autism. The long-term vision for OATS is to evaluate behavioral and physiological responses of autistic children, including heart rate variability, pupil dilation, and EEG. Our first objective is to use existing animations to build an OATS "Prototype" that discriminates autistic from normal children (Aim 1). From these results, and use of a defined library of still frame posed images, we will design our own animation platform to assess differences between autistic and normal children (Aim 2).

Please see the brief summary above.

Eligibility Criteria:
Inclusion Criteria:

* 6-11 years of age with autism,
* ADHD, or typical

Exclusion Criteria:

* IQ below 70.
Initial Combination With Pioglitazone Study (0431-064)

A clinical study to evaluate the safety and efficacy of the initial combination therapy with sitagliptin and pioglitazone in patients with type 2 diabetes mellitus not on treatment with insulin or oral antihyperglycemic therapy.


Eligibility Criteria:
General Inclusion Criteria:

* Patients ≥18 years old with Type 2 Diabetes Mellitus (a specific type of diabetes)

General Exclusion Criteria:

* Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
* Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 4 months
* Patient was on \>4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 2 years
Entertainement and Training After a Hip Fracture

Older persons are at riskt for falls and fractures. After hip surgery they are normally treated with physical or occupational therapy. The additional use of computer based exercise games for training and the acceptance of such a technology are unclear. Thus, we plant to assess the above outcome ins an observational pilot study.

Falls and fall-associated fractures have a big medical burden on our societies. Older persons who suffer from a fall that leads to a trauma and fracture often loose functional capacity. They may have prolonged mobility problems and are at risk for long-term care or nursing home institutionalization. To date, measures to prevent such negative outcomes are early mobilization and functional physical or occupational therapy immediately following orthopedic surgery. In addition, patients usually are asked to train at home after hospital discharge. This can be achieved by a home training program or by ambulatory physical therapy. Recent technological development has introduced computerized training and gaming platforms into geriatric rehabilitation settings and home exercise training. Games that have been developed for a younger population have now been adapted to the needs of older persons. A recent systematic review has demonstrated that such platforms. for example Wii significantly improve balance and therefore have the potential to prevent falls\]. However to date such platforms have not been evaluated in a defined geriatric hospital patient population (e.g. after a hip fracture) as an adjunct to in-hospital physical therapy. Thus, such platforms could be offered as an additional training opportunity.

Eligibility Criteria:
Inclusion Criteria:

Living at home or in a retirement home (independent living situation) Time between surgery and the start of the gaming intervention less or equal 10 days Patient must be able to ambulate and to have full weight bearing

Exclusion Criteria:

The following exclusion criteria will apply

* Acute delirium (daily delirium observation score \> 3 during the first three consecutive days) lasting for more than 10 days. If the delirium resolves within the 10 day period (see above) patients without cognitive decline are still eligible.
* A history of severe dementia prior to admission or poor cognition at admission after exclusion of delirium (MOCA score \< 15 or MMT \< 15).
* Patients who were initially admitted from a nursing home
Accidental Falls Care Bundle

Accidental falls represents an elderly very important health problem, both in the community and within the hospital. The aim of this research project is to evaluate the effectiveness of accidental falls prevention care bundle in geriatrics, internal medicine, post acute, and rehabilitation wards, in terms of incidence and outcome reduction. It will be also investigated the cost effectiveness ratio, in terms of falls avoided, care bundle implementation costs, and falls related healthcare costs. The study will permit to evaluate the implementation feasibleness in time, considering the study will last for 20 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ≥ 75 years of age with or without documented fall risk and patients with \< 75 years of age, but ≥ 18, only at documented fall risk, admitted at participant wards. The risk assessment will be performed with Conley scale and/or on the base of some specific fall risk characteristics (previous falls, cognitive impairment, neuropsychological damage, increased need to go to the bathroom for increased evacuative needs, neuroleptic or cardiovascular drugs assumption);
* Patients (or legal guardian for those incapable of giving their consent) that give their consent to the study participation .

Exclusion Criteria:

* Patients or legal guardian that don't give their consent to study participation.
Significance of Duration of Maintenance Therapy With Rituximab in Non-Hodgkin Lymphomas

The purpose of this study is to determine if an extended maintenance therapy with Rituximab in follicular and a maintenance therapy in other indolent and mantle cell lymphomas has advantages compared to a shorter or no maintenance therapy.

Results from several randomised studies show a clinical benefit of a maintenance therapy with rituximab in follicular lymphomas. The advantage of a maintenance therapy in other indolent and mantle cell lymphomas is - due to the lower incidence of these diseases- not well investigated.

This study tries to determine the significance of an extended maintenance therapy with rituximab in follicular lymphomas and the significance of a maintenance therapy other indolent and mantle cell lymphomas compared to observation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histological verified CD20-positive B-Cell-Lymphoma of the following entities:

  * Follicular Lymphoma Grade 1 and 2
  * Lymphoplasmocytic lymphoma / Immunocytoma (Morbus Waldenström) and small cell lymphocytic lymphoma (CLL without leukemic hemogram)
  * Marginal zone lymphoma, nodal and extra nodal
  * Mantle cell lymphoma
* No prior therapy with cytotoxics, interferon or monoclonal antibodies
* Need for therapy, except mantle cell lymphomas
* Stadium III or IV or Stadium with II bulky disease (\> 7 cm diameter, or 3 lesions \> 5 cm)
* General condition WHO 0-2
* Age min. 18 years, max. 80 years
* Negative pregnancy test, contraceptives mandatory for women of child-bearing age
* Actual histology, not older than 6 months required
* Written informed consent

Exclusion Criteria:

* Patients not meeting the inclusion criteria above
* Possibility of a primary radiation therapy with curative intention
* Pretreatment, except a single, localized radiation therapy (radiation field not larger than 2 adjacent lymph node regions)
* Co-morbidities, excluding a therapy according to the protocol:

  * severe, medicinal not adjustable hypertension
  * severe limited capacity of the heart (NYHA III or IV), the lung (WHO-Grade III or IV), the liver and kidneys (creatinin \> 2 mg/dl, GOT and GPT or bilirubin 3 x ULN), except if caused by lymphoma
  * severe, medicinal not adjustable diabetes mellitus
  * active autoimmune disease
  * active infection, requiring antibiotic therapy
* Patients with proven HIV-infection
* Active replicating hepatitis-Infection
* Severe psychiatric diseases
* Lacking or anticipated non-compliance
* Known hypersensitivity against the active components or additives or mouse- proteins
* Pregnant or nursing women
* Patients with a secondary malignancy or malignant disease in his history if, curative surgery can not be doubtless assured .
A Study to Investigate How JNJ-38518168 May Affect the Plasma Levels of Methotrexate in Rheumatoid Arthritis Participants

The purpose of this study is to evaluate the effects of JNJ-38518168 on the pharmacokinetics (how the body handles a drug) of methotrexate in participants with rheumatoid arthritis.

This is an open-label (physician and participant will know the name of the assigned drug), multi-center, non-randomized, drug/drug interaction study of JNJ-38518168 in participants with rheumatoid arthritis (RA) on a stable oral methotrexate (MTX) dose (7.5-25 mg). The treatment phase will last 16 days. Participants will be housed in the clinic for dosing and study procedures from Day -1 to Day 2 and again from Day 14 to Day 16. Participants completing treatment will have a follow-up visit between Days 22 and 25. Participants who discontinue the study prematurely will complete the Day 22 to 25 follow-up procedures at the time of discontinuation or as soon as possible thereafter. The duration of participation in the study for an individual participant will be up to 7 weeks (including screening). Participant safety will be monitored. Day 1: A single oral dose of the participant's weekly methotrexate dose. Days 2-15: Weekly MTX co-administered with two 50-mg capsules of JNJ-38518168, administered daily.

Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) between 18 and 38 kg/m2 inclusive, and a body weight between 50-110 kg, inclusive
* Have a diagnosis of Rheumatoid Arthritis functional class I-III for at least 3 months prior to Screening
* Have been treated with and tolerated oral MTX treatment for a minimum of 3 months prior to screening and must have been on a once-weekly stable MTX dose (taken as a single dose) (between 7.5-25 mg/week) for a minimum of 1 month
* Participants may continue on stable non-steroid anti-inflammatory drugs and corticosteroid background therapy for RA or stable therapies for other conditions as prescribed by physician, provided that the doses of such therapy are stable for at least 1 month prior to screening and will remain unchanged for the entire study duration.

Exclusion Criteria:

* Have current signs or symptoms of liver or renal insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive or uncontrolled in the study doctor's opinion
* Have been treated with a monoclonal antibody for RA or have had a serious infection with 2 weeks of the study treatment period.