cyrilzakka/clinical-trials huggingface dataset:
Olfaction Changes in Patients Undergoing Spine Surgery

This observational prospective study evaluates perioperative olfaction alterations, comprising changes in threshold value, discrimination and identification, which occur in spine patients. The single group is subjected to a preoperative and a postoperative assessment.


Eligibility Criteria:
Inclusion Criteria:

* Males or females
* Caucasian race
* Between 50 and 85 years of age
* Candidates to spine surgery
* Acceptance and signing of informed consent

Exclusion Criteria:

* Past or present cancer
* Heart failure
* Kidney failure (III-IV)
* Past or present neuropsychiatric disorders
* Heavy smokers (over/equal 3 cigarettes per day)
* Smell disorders
* Rhinitis
* Allergies to the respiratory system
DBT and Escitalopram in Borderline Personality Disorder

Subjects will receive six months of DBT, consisting of one 90-minute group and one 60-minute individual session per week as well as telephone availability of the individual therapist. Half the subjects will concurrently receive escitalopram while half will receive placebo, in a randomized double-blind design.


Eligibility Criteria:
Inclusion Criteria: Is a male or female between 18 and 60 who meets criteria for Borderline Personality Disorder and has been off psychotropic medications for at least 2 weeks (6 weeks for fluoxetine).

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Exclusion Criteria: Meets criteria for Schizophrenia, Bipolar Disorder, Mental Retardation, current or recent Substance Dependence or a current Major Depressive Episode. Subjects also should not currently be in individual psychotherapy. (Case management and work therapy programs are allowed.)

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Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants

The goal of this study is to determine what effect Cetaphil® Restoraderm® system has on babies' skin versus Johnson \& Johnson baby lotion and skin cleanser.

Subjects will randomly be divided into a group using Cetaphil® Restoraderm® system or a group using Johnson \& Johnson baby lotion and skin cleanser . At 3, 6, and 12 months non-invasive measurements of barrier function will be used to test the babies' skin. The procedures are as follows:

* Transepidermal loss (TEWL - measures the water loss from the skin)
* Skin electrical capacitance (measures how much water stays in the top layer of skin)
* Skin pH (measures level of pH)
* Skin microbiome analysis (skin swabs to check genetic code of skin bacteria)
* Lipidomic and natural moisturizing factor analysis (measures lipids (oils) in the top layer of skin)

Both groups will be reminded to follow the instructions about general good skin care of infants. Subjects will be asked if they agree to provide a saliva sample. If yes, a saliva sample will be collected from the inside of the infant's cheek at the 6 month visit and will be shipped to the laboratory of Dr. Irwin McLean at the University of Dundee, where it will be tested for gene defects in the skin barrier that might trigger the development of eczema. Defects in the gene called filaggrin have been shown to increase the risk of developing eczema. The samples will be identified by a code to protect your infant's identity. The saliva samples will be stored only for this study, and then the sample will be destroyed.

Eligibility Criteria:
Inclusion Criteria:

* Infants up to three weeks of age born to mothers aged 18-45 years will be recruited for this study.
* Infants must have a family history of asthma, eczema, or hayfever in at least one first-degree relative and be in otherwise good overall health.

Exclusion Criteria:

* Preterm birth defined as birth prior to 37 weeks gestation
* Major congenital anomaly
* Hydrops fetalis
* Significant dermatitis at birth not including seborrheic dermatitis on the scalp ("cradle cap")
* Any immunodeficiency disorder
* Any severe genetic skin disorder
* Any other serious condition that would make the use of emollients inadvisable
* Any other major medical problems that the investigator deems may increase the risk of adverse events with the intervention or in whom assessing the outcomes may be masked by the underlying problem or practically very difficult to assess
Walking Interventions, Cognitive Remediation and Mild Cognitive Impairment

The purpose of this study is to determine the effects of a coordinated intervention of cognitive remediation training (CRT) and walking intervention on cognition and gait in the elderly.

This is a single blind randomized study designed to understand the effects of different interventions, walking interventions and cognitive remediation in particular, towards cognition and gait in the elderly. The study uses a 4 arm approach consisting of 4 intervention groups, with each intervention lasting for 12 weeks. The investigators will investigate the effect of each intervention towards cognitive function and gait. All interventions will be conducted on site at the Pennington Biomedical Research Center, and will be focused on determining the effects of different combinations of walking, cognitive remediation, healthy living courses, and reading. Cognitive measures will include objective clinical measures related to dementia, and the gait analysis will include in clinic and "free living" measures related to falls.

Eligibility Criteria:
Inclusion Criteria:

* Men and women meeting all criteria listed below will be included in the study:
* Subjects between 65-85 years of age inclusive
* Subjects with Short Physical Performance Battery of 10 or greater
* Subjects averaging less than 5,000 steps per day
* Subjects with Mini Mental State Exam 25-28, inclusive
* Subjects with normal for age physical-neurological exam
* Subjects able to walk a city block without a walking aid
* Written Informed Consent obtained PRIOR to performing any study procedures

Exclusion Criteria:

* Subjects with difficult walking due to pain or posture
* Subjects with difficulty in using computer due to significant visual and/or fine motor impairment
* Subjects with large weight loss (\>15 Kilogram) in the last 12 months
* Subjects with geriatric depression scale \> 9.
* Subjects with Malignancies in the past 5 years, with the exception of skin cancer therapeutically controlled
* Subjects with abnormal electrocardiogram results. These include: a resting heart rate below 40 bpm or above 100 bpm, previously unknown and/or untreated atrial fibrillation or flutter, evidence of a third degree A-V block, a previously undocumented left bundle branch block, S-T segment depression of greater than 2 mm, evidence of a previous MI, or any other findings that in the clinical judgment of the medical investigator preclude participation in an exercise intervention.
* Subjects with shortness of breath, exertional angina, uncontrolled high blood pressure or any other chronic medical condition deemed by the physician to preclude participation in an exercise intervention.
* Subjects with any other medical condition or disease that is life-threatening or that can interfere with, or be aggravated by, exercise.
* Subjects who currently smoke.
Myelodysplasic Syndromes and Risk Factors for Infection

Myelodysplastic Syndromes (MDS) are characterized by quantitative and qualitative bone marrow failure and by a disorder of the medullary production which is a pre-leukemic state which can evolve into acute myeloid leukemia.

The risk of leukemic transformation is estimated by the score IPSS (International Prognostic Score System). We distinguish the MDS of low risk (IPSS\<1) and those of high risk of leukemic transformation (IPSS=1,5).

Besides the risk of leukemic transformation, MDS much be complicated of infections which could be life-threatening.

The risk of developing first infection after the diagnosis of MDS of high risk is probably influenced by anamnestic (disease duration, comorbidities), clinical (veinous central catheter, previous hospitalization), biological (neutropenia, lymphopenia, serum ferritin) and therapeutics (demethylating agent, lenalidomide, erythropoietin, G-CSF, transfusions, anti-infectious preventive treatment) factors. Their identification will allow for improved targeting of the population which is is likely to benefit from anti-infective prophylaxis Primary objective is to identify risk factors associated with first acute episode of infection in patients with MDS, by comparing index cases and matched control cases who did not develop infection episode since diagnosis.

Secondary objectives are to explore nature and severity of infectious episodes, number of recurrences during 1 year of follow up and survival at 6 and 12 months

* 160 couples (Case / Control)
* Pairing according to age (+/- 5 years), sex and medical consultation date (+/-15 days)
* Follow up at M3, M6, M9 and M12
* Study duration : 24 months
* Inclusion duration : 12 months

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* MDS with IPSS \>1.5
* With a first infectious episode since the diagnosis of SMD of high risk (Case)
* Unhurt of any infection and being able to be mated in the case index (Control)
* Consulting or hospitalized in one of the services involved in the study during the period of inclusion

Exclusion Criteria:

* None
The Effect of Obstructive Sleep Apnea and Its Treatment on Decision Making

Obstructive sleep apnea (OSA) is an extremely common disease with inadequately explored neurocognitive consequences. The investigators will study OSA patients before and after treatment to understand how OSA changes decision making abilities, and whether treatment can reverse such cognitive changes. These results could provide deeper insight into how OSA affects decision making either temporarily or permanently, and provide another rationale or motivation for treatment of OSA in adults.

The investigators hypothesize that OSA will lead to (H1) more reward-seeking and lower payoffs in the Iowa Gambling task, replicating previous findings; (H2) greater discounting of future rewards in financial choices; and (H3) these effects would dissipate when OSA is successfully treated.

In order to test these hypotheses, the investigators will perform cognitive tests (Iowa gambling; intertemporal choice; other measures) in 100 patients about to undergo sleep testing. It is expected that of these 100 patients, some will have no sleep apnea; some will have sleep apnea and will be successfully treated; and that some will have sleep apnea but will not be successfully treated by the time of repeat testing. The investigators will repeat testing using the same instruments 2 months later.

Thus the investigators will be able to compare whether OSA patients differ from control at baseline (t1), and whether OSA patients' performance will improve after treatment at t2, compared to the control at t2.

Eligibility Criteria:
Inclusion Criteria:

Subjects aged 18-75 referred to the UCSD Sleep clinic for either home or in-laboratory testing will be considered for inclusion in the study. Inclusion will not depend on gender, race or ethnicity, as per the following:

1. 100 participants will be enrolled at the UCSD Sleep Clinic at Chancellor Park.
2. Ages 18-75
3. Gender: Men and woman
4. Ethnic background: All
5. Health Status: to the UCSD Sleep clinic for either home or in-laboratory testing

Exclusion Criteria:

1. Ongoing CPAP treatment for OSA
2. Inability to use a tablet device (e.g. no reading glasses, or unfamiliar with devices).
3. Severe cardiopulmonary disorder that requires treatment with supplemental oxygen therapy.
4. Inability to speak English fluently, as some of the questionnaires/tests are only validated in English.
An Italian Observation of Antiretroviral Treatment in Participants Taking Darunavir/ Cobicistat Plus Emtricitabine and Tenofovir Alafenamide Fumarate

The purpose of this study is to describe the effectiveness of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF), measured as virological response at Week 48 as per Food and Drug Administration (FDA) snapshot algorithm through collection of daily practice data in the Italian setting.


Eligibility Criteria:
Inclusion Criteria:

* Having a confirmed diagnosis of Human Immunodeficiency Virus-1 (HIV-1)
* Must sign a participation agreement/Informed Consent Form (ICF) allowing data collection and source data verification in accordance with local requirements
* Taking Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) as per Summary of Product Characteristics (SmPCs) since at least one month before enrollment:

  i) Experienced participants \[Group 1 and 2\]: a) started their antiretroviral (ARV) treatment not before 1/1/2015, b) having at least 1 year of ARV treatment history at study enrollment, c) Group 1, having always been treated with Darunavir (DRV) since the start of ARV treatment as naïve, d) Group 2, not having been treated with DRV before starting of D/C/F/TAF, ii.) Naive (any Viral Load (VL) participants (Group 3)

Exclusion Criteria:

* Participants unable to read, to write, to understand and sign the ICF
* Currently enrolled in an interventional study
* Currently enrolled in an observational study sponsored or supported by Janssen
* Chemotherapy scheduled during study observation
Comparison of Thermometry in Canada for Pediatrics

Compare and assess the accuracy and reliability of the InstaTemp MD® device to techniques presently in use for measuring temperature in infants and children in a Canadian clinical setting.

This study is designed as a multi-center study. This study will involve collecting temperatures on patients using the InstaTemp MD® device and the traditional method used in the clinical setting. Reliability and agreement of the InstaTemp MD® will be compared to the current Canadian Paediatric Society's definitely recommended methods of temperature measurement in certain age cohorts of infants and children.

Eligibility Criteria:
Inclusion Criteria:

* Children Age 1 month to ≤ 10 years old
* Male or female
* Subject's parent or legal guardian over the age of 18 years must sign an informed consent form before any study-related procedures are performed
* Subjects who in the opinion of the investigator (or as required by the ethics committee) have the capacity to understand and sign an assent form, must provide written assent

Exclusion Criteria:

* Subjects who in the opinion of the researcher are too agitated, distressed or who are otherwise unable to cooperate with study procedures
* Subjects whose forehead cannot be fully exposed to the ambient condidtions for at least 15 minutes.
* Subjects with signs or recent history of inflammation or infection of the forehead or at the reference clinical test site.
* Subjects currently using cooling blankets or fans
* Subjects with tubes in their ear(s) cannot participate in the tympanic comparison, but this is not exclusionary for InstaTemp MD and definitive comparator (e.g. rectal or oral) measurements.
* Subjects currently receiving treatment with thyroxine, barbiturates, antipsychotics, cortico-steroids (oral iv, or topically applied to forehead)
* Subjects currently alcohol intoxicated
* Subjects with documented illicit durg use in the previous 5 days
* Subjects that have had any hot or cold drinks within 15 minutes prior to a sublingual reading
* Subject is taking any medication that in the opinion of the investigator may alter the temperature of the child
* Subjects participating in a clinical trial of an investigational medicinal product within the last 30 days.
Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma

The goal of this study is to determine a safe dose of GR-MD-02 used in combination with the FDA-approved dose of ipilimumab (3 mg/kg) in patients who have advanced melanoma. GR-MD-02 is a galectin. Galectins are a family of proteins that have numerous functions in normal mammalian biology including the facilitation of cell-cell interactions, regulation of cell-death and regulation of immune system responses. The hypothesis is that a safe dose of GR-MD-02 when given with the FDA-approved dose of ipilimumab can be found.

This study will employ a 3+3 phase I design with dose escalation of GR-MD-02 in conjunction with the standard therapeutic dose of ipilimumab in patients with advanced melanoma for whom ipilimumab would be considered standard of care. In addition to monitoring for toxicity and clinical response, blood samples will be obtained to assess immunologic measures relevant to galectin biology and ipilimumab T-cell check-point inhibition

Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic or unresectable melanoma for whom treatment with ipilimumab is indicated. Histological confirmation of melanoma will be required by previous biopsy or cytology.
* Patients must be ≥ 18 years of age.
* Eastern Collaborative Oncology Group (ECOG) performance status of 0-1.
* Women of childbearing potential must have a serum or urine pregnancy test performed within 72 hours prior to the start of protocol treatment. The results of this test must be negative in order for the patient to be eligible. In addition, women of childbearing potential as well as male patients must agree to take appropriate precautions to avoid pregnancy.
* No active bleeding.
* Anticipated lifespan greater than 12 weeks.
* Patients must sign a study-specific consent document.

Exclusion Criteria:

* Patients who have previously received a galectin antagonist
* Prior ipilimumab to treat metastatic melanoma (prior ipilimumab in the adjuvant setting is permitted if the patient did not experience ≥ grade 3 toxicity related to immunotherapy.
* Patients with active autoimmune disease except for autoimmune thyroiditis or vitiligo.
* Patients with history of colitis
* Patients with untreated brain metastases. Patients with treated brain metastases who demonstrate control of brain metastases with follow-up imaging 4 or more weeks after initial therapy are eligible.
* Other active metastatic cancer requiring treatment.
* Patients with active infection requiring antibiotics.
* Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
* Laboratory exclusions (to be performed within 28 days of enrollment):
* Need for chronic steroids. Inhaled corticosteroids are acceptable.
* Inability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy.
* Any medical condition that in the opinion of the Principal Investigator would compromise the safety or conduct of the study procedures.
Treatment of Pemphigus Patients With Rituximab 1000mgX2 and Assessment of Immune Status Via Cylex

The purpose of this study is to determine whether Rituximab, in the same doses as used in rheumatoid arthritis patients, will benefit pemphigus patients. It also tests immune function via the Cylex assay in pemphigus patients before and after treatment with RItuximab.


Eligibility Criteria:
Inclusion Criteria:

1. Pemphigus patients with moderate-severe disease

Exclusion Criteria:

1. Pregnancy or lactation
2. Woman of reproductive age not using birth control measures.
3. Prior severe allergy or anaphylaxis with a human monoclonal antibody
4. Heart failure
5. Unstable angina or ischemic heart disease
6. Uncontrolled arrhythmia
7. HIV positive
8. Active hepatitis B infection or positive for hepatitis C virus (HCV) antibodies.
9. Severe dementia or a psychiatric illness
10. Active acute infection
Study to Investigate Bronchial Arterrial Infusing (BAI) Plus Three-dimensional Conformal Radiotherapy (3DCRT) in Local Advanced Non-small Cell Lung Cancer (NSCLC)

The purpose of this study is to investigate the efficacy of BAI Plus 3DCRT in local advanced NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* stage IIIA\&IIIB NSCLC
* male or female, Age ≥18Years, ≤70Years
* Life expectation of at least 12weeks.
* PS performance 0-2
* Measurable disease according to the Response Evaluation Criteria in Solid Tumours ( RECIST)

Exclusion Criteria:

* Patient with prior chemotherapy or radiology for IIIA or IIIB NSCLC
Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002

This extension study of subjects previously enrolled in studies CTAP101-CL-3001 or CTAP101-CL-3002 allows long term evaluation of the safety and efficacy of CTAP101 Capsules in reducing elevated intact parathyroid hormone (iPTH) and correcting vitamin D insufficiency in stage 3 or 4 chronic kidney disease patients.

Only subjects previously enrolled in studies CTAP101-CL-3001 or CTAP101-CL-3002 are eligible to participate in this extension study. This is a phase 3, open-label study of CTAP101 Capsules, with and without add-on vitamin D hormone therapy.

Eligibility Criteria:
Inclusion Criteria:

* Completed either of the phase 3 double-blind, placebo-controlled studies, CTAP101-CL-3001 or CTAP101-CL-3002
* Taking no more than 1000 mg/day of elemental Ca and willing/able to remain on this dose for the duration of the study
* Taking no more than 1600 IU/dose vitamin D (ergocalciferol or cholecalciferol) therapy and willing/able to remain on a stable dose of vitamin D during the study
* Willing and able to comply with study instructions and to commit to all clinic visits for the duration of the study
* Female subjects of childbearing potential must be neither pregnant nor lactating and must have a negative urine pregnancy test
* All female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use effective contraception (eg, implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence, vasectomy or vasectomized partner) for the duration of the study
* Have the ability to read and understand subject Informed Consent Form (ICF). Subjects or their legal representatives must sign the ICF.

Exclusion Criteria:

* Use of pharmacological dose of ergocalciferol and cholecalciferol (monthly equivalent of 50,000 IU or 1250 µg, eg, Drisdol®) or bisphosphonate therapy
* Use of other bone metabolism therapy (with the exception of stable doses of bisphosphonates and denosumab \[Xgeva® and Prolia®\]) that may interfere with study endpoints
* Concomitant serious illness or medical condition, such as malignancy, human immunodeficiency virus, significant gastrointestinal or hepatic disease or cardiovascular event or hepatitis that in the opinion of the investigator may worsen and/or interfere with participation in the study
* Neurological/psychiatric disorder, including psychotic disorder or dementia, or any condition reason which, in the opinion of the investigator makes adherence to a treatment or follow-up schedule unlikely
* Known or suspected hypersensitivity to any of the constituents of either investigational product (CTAP101) or adjunctive vitamin D hormone therapy