cyrilzakka/clinical-trials huggingface dataset:
Breath Biomarkers for Sleep Loss and Circadian Timing

Insufficient sleep has both health and safety risks, but currently there are no quick, accurate and inexpensive ways to measure sleep deficiency. The current study aims to use a cutting-edge technology, small molecule analysis (e.g. metabolomics), to detect compounds in breath that reliably change with sleep-wake state and those whose levels vary by time of day.

The goal of the study is to use a small molecule analysis (e.g. metabolomics) device to measure compounds in breath that may change with sleep-wake state and compounds that vary by time of day. Participants will be fitted with a plastic mask connected to the device for a breath analysis test for about 20 minutes. Then, participants may be asked to lie down and take a nap or to remain sitting/lying down for 1-2 hours. After such time, participants will be asked to complete another \~20 minute breath analysis test. Participants will be asked to complete questionnaires throughout the study session. Investigators may ask participants to provide up to two saliva samples during the study session. Participants will also be asked to complete a pre-study diary to document sleep/wake times, diet, and medications for the day before the study session. Participants may be asked if they would be willing to take part in an additional study session on another day.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Adults who are able to fall asleep in the study conditions
* Beginning 2 hours before the study, participants will be asked to refrain from brushing their teeth, using mouthwash, eating or drinking anything (other than water), chewing gum, smoking, etc., until the study is complete.

Exclusion Criteria:

* Individuals on special diets (such as a very low carbohydrate diet) may be excluded
* Acute or debilitating medical condition
* Recent history of dental problems (gum disease, abcess, surgery) or current dental or mouth pain
* Current use of stimulants, hypnotics, tranquilizers, Central Nervous System active substances, and/or antibiotics.
* Use of products containing nicotine 24 hours prior to study
A Pilot Dose Escalation Trial of a Densified Chemotherapy Association of Docetaxel and Epirubicin Driven by Mathematical Modeling in Metastatic Breast Cancer Patients: The MODEL1 Study

To determine the maximum tolerated dose of a densified regimen of the association of docetaxel (DTX) and epirubicin (EPI), supported by the concomitant administration of hematopoietic growth factors in patients with metastatic breast cancer in first-line, optimizing in each patient the administration schedule using a formal procedure based on mathematical models in order to manage the severity of induced neutropenia.

The models used in this project allow:

* an optimal administration schedule of the planned total dose per cycle (number of infusions and calculating their rates and durations)
* an individualization of the administration schedule from the second cycle (based on observations from the first cycle), and
* an assessment of the risk of a dose-limiting toxicity event combining several severe non-hematological toxicities (conditioning the decision for dose escalation).

Using formal mathematical models the investigators expect controlling the hematological and non-hematological toxicities in order to realize the full series of six cycles of densified DTX+EPI chemotherapy (2 weeks per cycle) for each patient. For each patient, chemotherapy is considered feasible if it is possible, in the absence of tumor progression, to consider 6 cycles of treatment without observing any serious adverse events and without:

* patient death that may be related to the treatments;
* decision of the patient to interrupt treatment for physical or psychological tolerance reasons;
* decision of the investigator to discontinue treatment, in the absence of disease progression.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years,
* ECOG performance status ≤ 2
* Diagnosed with metastatic HER2-negative hormone-resistant chemotherapy-naive breast cancers, previous adjuvant chemotherapy treatment are allowed.
* Histologically or cytologically proven breast cancer metastases or associated with CA 15-3 levels 50% above the normal value
* Hormone resistance defined by the presence of negative hormone receptors or disease progression within 6 months of the initiation of hormone therapy.
* Adequate renal and liver function (ASAT and ALAT \< twice the upper limit normal value (ULN) if no liver metastases, or \< 4×ULN if liver metastases; total bilirubin \< 2×ULN),
* Adequate cardiac function (left ventricular ejection fraction (LVEF) \> 50%),
* Neutrophils ≥ 1200/mm3
* Platelets ≥ 105/mm3

Exclusion Criteria:

* Cerebral metastases and meningeal involvement,
* Other malignant diseases,
* Significant comorbidities,
* Previous chemotherapy for metastatic disease, or previous chemotherapy with a total cumulative dose greater than 600 mg/m² for EPI or greater than 450 mg/m² for DTX
The Influence of Stability Boots on Gait Pattern in Healthy Adults

After an ankle injury like distorsions, fractures or arthrodeses, or congenital defects ankle support limit the range of motion in the joint, help pain relief, control loading of the injured tissues and promote recovery of a normal gait pattern. Gait analysis is applied in orthopedics, sport science and rehabilitation. Numerous measure systems and methods enable accurate analysis of human movement.

The study is set to describe and compare the gait analysis of two modifiable stability boots (Ortho® Tri-Phase and the VACOped®) on the standard walking parameters during two conditions (level and ramp walking) in healthy adults and draw comparisons with a control indoor shoe.

The participants are joining one session in the gait lab. Here the are measured during walking with normal shoes and two modifiable stability boots. The duration of a session is typically 3 hours.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* 18-45 years old
* shoe size 5,6,9 or 10

Exclusion Criteria:

* injuries of the lower limbs
* previous surgeries on the lower limbs
* neuromuscular disorders
* restriction in gait capabilities
* current medical treatment
Dermacyd Femina (Lactic Acid) Pocket BR - Compatibility

To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Femina (Lactic Acid) Pocket BR.


Eligibility Criteria:
Inclusion criteria:

* Age between 18 and 60 years old;
* Phototype Skin I,II, III e IV
* Integral skin test in the region;
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

Exclusion criteria:

* Lactation or gestation
* Use of Antiinflammatory and/or immunosuppression drugs one month before the study;
* Personnel history of atopy;
* History of sensitivity or irritation for topic products;
* Active cutaneous disease;
* Use of new drugs or cosmetics during the study;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Remote Assessment of Lung Disease and Impact on Physical and Mental Health

This cohort study aims to use the open-source RADAR-base mHealth platform to collect and analyze datasets associated with lung disease. This will include continuous data collected from wearable devices (e.g. heart rate, oxygen saturation, respiratory rate), including pulse oximeters, spirometer, mobile phones, digital tests, and smart phone symptom questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* 20 patients with a diagnosis of COPD
* 20 patients with a diagnosis of interstitial lung disease
* 20 a clinical diagnosis of COVID-19 (within 4-13 weeks of enrolment) who either and report symptoms interfering with day to day activity present for more than 28 days following the onset of COVID-19
* Prior mobile phone use
* Willingness to use monitoring devices and complete study questionnaires.
* History of exacerbation (COPD: 2 or more exacerbations in last 1 yr)

Exclusion Criteria:

* Non English language Speaker
* Lack of physical capability to take part e.g. Heart Failure
* Pregnancy
* Lack of capability to consent
A Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate in Lateral Epicondylitis (Tennis Elbow)

This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of human Platelet Lysate (HPL) in subjects with Lateral Epicondylitis (Tennis Elbow). The study is being conducted in 2 centers in India. The primary end points are Visual Analog Score (VAS) and Patient rated tennis elbow evaluation (PRTEE) score. The secondary endpoint is improvement in ultrasonography form randomization to End of study.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with clinical diagnosis of tennis elbow within the last 3 months
* Subjects both male and female, aged 18-60 years (both inclusive)
* Subjects who are willing to give informed consent and adhere to the study protocol

Exclusion Criteria:

* Subjects aged less than 18 and more than 60 years
* Subjects with autoimmune diseases
* Subjects with immuno-compromised system
* Subjects on Anti-coagulant therapy or blood thinning medicines like Aspirin
* Subjects taking concomitant therapy that might interfere with the study results in investigators opinion or who had concomitant other injury of the tennis elbow tendons.
* Subjects who have received treatment with corticosteroid injections within the last 6 months
A Trial of Panobinostat and Trastuzumab for Adult Female Patients With HER2 Positive Metastatic Breast Cancer (MBC) Whose Disease Has Progressed on or After Trastuzumab

The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat plus trastuzumab. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer

This phase Ib/IIa study was prematurely terminated due to lack of efficacy noted in 55 patients with HER2-positive MBC who had progressed on or following a trastuzumab-based therapy.

Eligibility Criteria:
Key Inclusion criteria:

* Age \> 18 year old
* Confirmed HER2+ ve metastatic breast cancer
* Prior treatment and progression on trastuzumab
* Patients must have adequate laboratory values
* Eastern Cooperative Oncology Group (ECOG) performance status of \<2

Key Exclusion criteria:

* Patients with active central nervous system (CNS) disease or brain metastases except those who have been previously treated and have been stable for at least 3 months.
* Impaired heart function or clinically significant heart disease
* Impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of LBH589
* Ongoing diarrhea
* Liver or renal disease with impaired hepatic or renal functions
* Concomitant use of any anti-cancer therapy or certain drugs
* Female patients who are pregnant or breast feeding
* Patients not willing to use an effective method of birth control
GI Biorepository of Tissue and Bodily Fluids

The purpose of this study is to establish the working protocols for a general biorepository with the specific aim of procuring tissues and bodily fluids from the human gastrointestinal tract from a diverse range of clinical patients at the UC Davis Medical Center. The establishment of a GI-specific biorepository will support future translational endeavors within the UC Davis campus by providing laboratories with readily available GI tissue and bodily fluid samples to test newly developed hypotheses with relative ease.

UC Davis is currently lacking a general use biorepository for GI tissues and bodily fluids. As with any translational research study, the procurement of human tissue samples can be a difficult and time- consuming process. The establishment of this biorepository will help streamline GI biospecimen collection and centralize these samples in a conveniently located space to facilitate the implementation of future unspecified translational studies.

Eligibility Criteria:
Inclusion Criteria:

* all consenting adults aged 18 years or older with an appointment with a healthcare professional in the Division of Gastroenterology or the Department of Surgery

Exclusion Criteria:

* minors, pregnant women, prisoners, and all other vulnerable populations who are unable to consent.
Complex Chronic Diseases Program Data Registry

The purpose of this data registry is to prospectively collect data from patients referred to an Complex Chronic Diseases Program (CCDP) at BC Women's Hospital + Health Centre to assess the quality of life of the CCDP Patients before, during and after their care at the CCDP.

1. Before their initial intake appointment, all CCDP patients are given a patient binder that includes the baseline Standardized Questionnaires. These are clinical questionnaires that all patients complete regardless of whether or not they consent to participation in research. In addition to the questionnaires completed at baseline, patients who consent to participate in the data registry will complete the questionnaires, via email or paper copy, at the following time points: approximately 6 months after intake, at discharge and 3 months post-discharge.
2. Patients who consent to the data registry will also be asked to complete a short questionnaire collecting basic demographic information at baseline. The demographic questionnaire will be either mailed to their home or sent via an online link; the investigators will ask participants to complete this form either before or when they come in for their first in-person visit at the CCDP.
3. Additional data will be collected and entered from the clinical chart. Specifically, after the patient's initial clinic appointment, the Research Coordinator or designate will enter data points from the Interdisciplinary Assessment Tool, into REDCap.

Eligibility Criteria:
Inclusion Criteria:

* Newly referred patients of the Complex Chronic Diseases Program
* Must be able to read and understand English
* 18 years of age or older

Exclusion Criteria:

* Have not completed the Standardized Questionnaires booklet prior to the initial intake assessment.
Pilot Study Using an NMDA Antagonist to Modulate Transcranial Direct Current Stimulation (tDCS) Effects on Sensory Discrimination

Transcranial direct current stimulation (tDCS) is a non-invasive form of brain stimulation which uses a very weak constant current to temporarily excite the brain area of interest via small electrodes placed on the scalp. Currently, tDCS is being used as a tool to investigate mental processes (cognition) and motor function (movement) in healthy controls and to treat neurological (i.e. stroke) and psychiatric (i.e. depression and dementia) patients. tDCS has been found to improve motor processes and cognitive performance, including attention and memory functions. This study will attempt to examine the effects of tDCS on a specific aspect of short term memory to sounds measured from electrical activity (EEG) from the top of the scalp. This study will also assess the effect of a drug, dextromethorphan (DMO), commonly found in cough syrup, which is thought to regulate tDCS treatment through brain receptors. The study involves four laboratory test sessions. EEG assessments will be done in two sessions involving 'anodal' tDCS stimulation (to temporarily excite cortical activity locally), one session with DMO treatment and one with placebo treatment, and two sessions involving 'sham' tDCS stimulation (device is turned off), with the same DMO and placebo treatments. These findings will contribute to our understanding of the brain chemistry involved in tDCS treatment and its effects on cognitive abilities.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, medication free
* Non-smoker
* Right-handed

Exclusion Criteria:

* Any current or past Axis I or Axis II disorder including a current or recent history of alcohol/substance abuse
* A clinically significant medical illness or organic brain disorder known to cause psychosis or cognitive impairment
* Any neurological diagnosis (including epilepsy)
* Recent head trauma (\<6 months)
* Metallic implants or any electrical device (e.g., pacemaker) in the body
* Major learning disability
* Body mass index \>38kg/m¬2
* Use of illicit drugs
* Abnormal hearing
Comparison Between Injection Molded Polyetheretherketone (PEEK) Framework and Cobalt Chromium Framework Removable Partial Dentures Regarding Periodontal Health of Abutment Teeth

This study is aiming to evaluate the periodontal status of the abutment teeth in Polyetheretherketone ( PEEK ) framework partial dentures compared with cobalt-chromium ones in mandibular kennedy class I edentulous cases aiming to preserve the optimum periodontal health of the abutment teeth .


Eligibility Criteria:
Inclusion Criteria:

* Kennedy Class I partially edentulous subjects indicated for framework partial denture

Exclusion Criteria:

* 1- uncooperative patients . 2- bad oral hygiene patients .
Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements

This research study is being conducted to determine if taking oral (by mouth in pill form) Apatone®B (a combination of Vitamins C and K3) will reduce chronic joint discomfort and improve function of non-infected symptomatic postoperative total joint replacements.

To perform a prospective, randomized, double-blind clinical trial to determine if oral Apatone®B, an amalgam of vitamins C and K3, has a therapeutic efficacy beyond the conservative care customarily used to reduce inflammatory synovitis and to increase the functional capacity of proven non-infected symptomatic postoperative total joint replacements.

Eligibility Criteria:
Inclusion Criteria:

* Postoperative Total joint replacement with osteoarthritis as the underlying pathology
* Proven non-infected symptomatic Total Joint Arthroplasty (TJA) (joint implanted for \>12 months post-op)
* Age (50 to 85 years of age); based on a 10% trim of the age distribution for Summa Health System TJAs (7/1/08-6/30/2009).

Exclusion Criteria:

* An infection of any kind (prior to, or during the study)
* Rheumatoid arthritis as the underlying pathology
* Cortisone injection received \<6 months prior to study enrollment
* Insulin dependent diabetes
* Diagnosed immunodeficiency
* On dialysis or have poor kidney function
* Anti-coagulant medication (e.g., Coumadin or \>100mg of Aspirin daily)
* Anti-seizure medication (e.g., Dilantin)
* Steroidal medication (e.g., Prednisone, Advair or Symbicort)
* NSAIDS (e.g., Celebrex or Toradol); a 14-day washout period will be allowed
* bisphosphonates (e.g., Fosamax, Actonel, Aredia, Didronel, Boniva or Reclast)
* hormonal therapy (e.g., Estrogen, Progesterone or Testosterone)
* Cancer (active or in remission)
* Planned concurrent vitamins exceeding a standard daily multivitamin or exceeding the Recommended Daily Allowance (RDA) for individual vitamins if used alone; a 72 hour wash out period will be allowed
* A glucose-6-phosphate dehydrogenase (G6PD) deficiency
* Pregnant or lactating; females who are in their reproductive years must have a negative serum pregnancy
* Lactose intolerant
* Citric acid intolerant
Pilot Study of BOTOX for Migraine Headaches

The purposes of this study are to assess whether subjects treated with BOTOX will:

1. have a decrease in the frequency and intensity of migraine headaches
2. experience improvements in quality of life
3. experience a reduction in the frequency of health care services obtained.


Eligibility Criteria:
Inclusion Criteria:

* Subjects \> 18 years of age
* Subject has an established history of migraine headache, with or without aura, per IHS criteria (1.2.1 or 1.1), for at least 6 months prior to screening.
* Subject receives primary health care from Park Nicollet Health Services.

Exclusion Criteria:

* Subject has received previous injections of botulinum toxin of any serotype for any reason, within the 6 months prior to study participation.

Additional eligibility will be discussed at point of contact
The Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis

The primary objectives of this study were: to evaluate the effect of Tysabri® (natalizumab) on antibody responses after immunization with a neoantigen (keyhole limpet hemocyanin \[KLH\]) and a recall antigen (tetanus toxoid \[Td\]), and to evaluate the effect of Tysabri on circulating lymphocyte subsets (CD3+, CD4+, CD8+, CD19+, and CD56+) over time in participants with relapsing forms of multiple sclerosis (MS). The secondary objective was to assess alpha4-integrin saturation and alpha4-integrin expression levels over time.


Eligibility Criteria:
Inclusion Criteria:

* able to give written informed consent
* diagnosis of a relapsing form of MS and must fall within the therapeutic indication stated in the approved label for Tysabri
* aged 18-60 years, inclusive at the time of consent
* free of signs and symptoms suggestive of any serious opportunistic infection, based on medical history, physical examination, or laboratory testing
* must have a known history of tetanus toxoid immunization

Major Exclusion Criteria:

* tetanus toxoid vaccination less than 2 years prior to Screening
* known hypersensitivity to tetanus-diphtheria vaccine or KLH or any other administered vaccinations or their components (such as thimerosal)
* known allergy to shellfish
* history of active tuberculosis or undergoing treatment for tuberculosis
* previous exposure to KLH or vaccines containing KLH components (e.g., cancer vaccines)
* known history of human immunodeficiency virus (HIV), hepatitis C, or hepatitis B infection
* history of, or available abnormal laboratory results indicative of any significant disease
* history of malignancy
* history of organ transplantation (including anti-rejection therapy)
* history of severe allergic or anaphylactic reactions or known drug hypersensitivity
* a clinically significant infectious illness within 30 days prior to the Screening visit
* prior exposure to Tysabri, rituximab, any murine protein, or any therapeutic monoclonal antibody at any time
* receipt of intravenous (IV) or intramuscular (IM) immunoglobulin within 6 months of screening
* live virus, bacterial vaccines, or any other vaccines within 3 months of screening
* treatment with immunosuppressant medications within 6 months prior to screening
* treatment with cyclophosphamide within 1 year prior to screening
* treatment with immunomodulatory medications (interferon beta and glatiramer acetate) within 2 weeks prior to screening
* treatment with systemic corticosteroids within 4 weeks prior to screening
* treatment with any investigational product or approved therapy or vaccination for investigational use within 6 months prior to Screening
* women who are breastfeeding, pregnant, or planning to become pregnant during the study
* female subjects who are not postmenopausal for at least 1 year, surgically sterile (does not include tubal ligation), or willing to practice effective contraception during the study