cyrilzakka/clinical-trials huggingface dataset:
Parkinson's Repository of Biosamples and Network Datasets (Tracking Parkinson's)

Prospective observational study of Parkinson's disease with repeat clinical assessment and biobanking of blood samples.

To identify genetic and biomarker factors which affect the expression of Parkinson's Disease.

Primary objective: To define the severity and rates of progression of clinical features of Parkinson's Disease.

Secondary objective: To relate clinical phenomenology of Parkinson's disease to genetic and biomarker changes.

Eligibility Criteria:
A. Parkinson's Disease patients

Inclusion criteria

1. Diagnosis of Parkinson's disease, based on UK Brain Bank criteria and made within the preceding 3 years ('recent onset cases') or diagnosed at under 50 years ('under 50 years cases')
2. Age ≥18 to \<90years
3. Subject is able and willing to provided informed consent.

Exclusion criteria

1. Patient has severe comorbid illness that would prevent full study participation
2. Patient has features indicating another type of degenerative parkinsonism, e.g. progressive supranuclear palsy
3. Drug-induced parkinsonism (Drug-unmasked PD is allowed)
4. Symmetrical lower body parkinsonism attributable to significant cortical and/or subcortical cerebrovascular disease (patients with 'incidental' small vessel disease on brain imaging are allowed).
5. Negative or normal functional imaging of the presynaptic dopamine system
6. The presence of UK Brain Bank exclusion criteria will be recorded at baseline, allowing for the presence of 1 or 2 exclusion criteria (e.g. dopamine antagonist Drug used; more than one affected relative) (if justified e.g. by abnormal SPECT).

B. First degree relatives Inclusion criteria

1. Age ≥18 to \< 90years
2. Resident in the United Kingdom and able to access one of the PRoBaND study centres.
3. Subject is able and willing to provided informed consent.

Exclusion criteria

1. Subject has severe comorbid illness that would prevent study participation
2. Subject already has a diagnosis of Parkinson's disease
A Phase I Study to Assess the Effect of Itraconazole and Rifampicin on Pharmacokinetics Profile of BPI-7711

This is a phase I study to assess the effect of itraconazole and rifampicin on the pharmacokinetic parameters of BPI-7711 in Chinese healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Male, aged from 18 to 45 years
* BMI from 18.5 to 28.0 kg/m2
* Medical history, vital signs, physical examination and lab tests are normal or abnormal without clinical significance

Exclusion Criteria:

* Subjects with clinical significant diseases
* Subjects with allergic disease history
* Subjects with gastrointestinal disease history that can affect study drug absorption
* Subjects with drug abuse history
Biomarker for Infection Risk in CLL and MM

The aim of this research study is to use advanced immunology laboratory analysis to identify a more precise blood test that will predict infection risk in patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL) or Multiple Myeloma (MM).

The goal of this research study is to identify an antigen-specific antibody profiling biomarker associated with increased risk of any infections in patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL) or Multiple Myeloma (MM).

Research procedures including screening for eligibility, clinic visits, and blood tests.

This involves performing blood tests which detect antibodies directed against specific pathogens and measure their functional capacity, and collecting information about outcomes in patients.

Participation in this research study is expected to last 2 years.

It is expected that about 150 people CLL or MM will take part in this research study, and this will predominantly include people with CLL/SLL.

Takeda is supporting this research study by providing funding.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years of age.
* Diagnosis of Rai stage I-IV chronic lymphocytic leukemia or small lymphocytic lymphoma or multiple myeloma.
* Subjects must be able to consent to clinical trial, or documented health care proxy agent able to consent on behalf of participant.

Exclusion Criteria:

* Subjects must not have received IVIG administration within 6 calendar months of registration or have planned immunoglobulin replacement therapy by treating investigator at time of registration.
* Subjects with chronic lymphocytic leukemia or small lymphocytic lymphoma must not be Rai stage 0.
* Subjects with multiple myeloma must not have smoldering myeloma or solitary plasmacytoma with or without minimal marrow involvement.
* Subjects must not have undergone prior autologous, allogeneic stem cell, or solid organ transplant.
* Subjects must not have any active systemic infection requiring ongoing antimicrobial treatment (prophylactic antimicrobial allowed) at time of registration.
* Subjects must have no known history of HIV, primary immune deficiency disorder, nor be taking a concurrent immune suppressing medication at time of registration. Treatment for CLL/SLL or MM, CLL/SLL related autoimmune phenomenon, or physiologic dosing of corticosteroids (5mg/day prednisone/equivalent or lower) is permitted.
The Effect of Spinal Anesthesia on Heart Rate Variability in Diabetic Patients

Cardiac autonomic neuropathy is a common complication of diabetes and is associated with resting tachycardia. Regional anesthesia could interrupt normal autonomic activity by central sympathetic blockade. The investigators evaluate the relation of severity of diabetes and heart rate variability, also the impact of spinal anesthesia on the change of heart rate variability.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing lower limb surgery with spinal anesthesia (ASA class 1,2,3)

Exclusion Criteria:

* severe coagulopathy, short height, arrhythmia patients, patients taken medication which could affect autonomic nervus system (bata- blocker or alpha-blocker)
Multicenter Phase II Study of Sentinel Node Detection in Squamous Cell Carcinoma T1-T2N0 of the Oropharynx Treated With Radiotherapy and Larynx Treated by Surgery, Laser or Robot

Fifty patients with squamous cell carcinoma of the larynx T1 or T2N0 will therefore have a 99mTc lymphoscintigraphy per operative. The identified sentinel node will be removed along with the other lymph nodes of the selective group II and III recess. Sentinel lymph node staging alone and complete dissection with routine anatomical pathology will be compared If this technique is reliable it will make a therapeutic de-escalation in the treatment of small tumors of the larynx by limiting the ganglionic gesture in the patients whose sentinel node is free from metastasis and also to better choose the treatment in case of lymph node involvement


Eligibility Criteria:
Inclusion Criteria:

1. Squamous cell carcinoma T1 or T2 of the oropharynx or larynx, clinical and computed tomography, M0,
2. previously untreated patient, without further concomitant localization,
3. patient over age 18 with no upper age limit, general condition WHO 0 or 1, life expectancy greater than 2 years,
4. on the cervical tomodensitometric assessment with injection of contrast agent: absence of adenomegaly suspicious of metastasis = ganglion of size less than one centimeter and 1.5 cm for group IIa, ovoid, homogeneous, not taking the contrast product And no signs of peri-ganglion invasion (fatty hyperdensity, vascular adhesion), absence of ganglionic grouping (\> 3)
5. Untreated patient outside a biopsy excision (melanoma experiment),
6. Possibility of realizing an IMRT
7. Informing the patient and signing informed consent.

Exclusion Criteria:

1) Patient already treated for this tumor outside a biopsy excision, 2) Contraindications to radiotherapy, scintigraphy or procedure, allergy to Rhenium sulphide or 99m Technetium 3) History of epidermoid carcinoma of VADS 4) Pregnant woman, likely to be pregnant or nursing, (5) Persons deprived of their liberty or under guardianship, 6) Impossibility to submit to the medical follow-up of the trial for geographical, social or psychological reasons.

7) Patient who underwent cervical surgery for any cause 8) Patient with cervical radiotherapy 9) Patient unable to undergo cervical lymph node dissection 10) Patient treated for another cancer outside the VADS within a period of less than 6 months.
Superior Laryngeal Nerve Block For Awake Endotracheal Intubation Study

Awake tracheal intubation is the standard management for patients as risk for airway compromise. It is also commonly done in cases where there is significant cervical spine pathology i.e. cervical myelopathy or instability. The anesthetic technique used for the awake intubation is crucial to the patient's safety. One of the most important aspects of the anesthetic technique is airway anesthesia prior to placement of an endotracheal tube. The superior laryngeal nerve is responsible for mediating the cough reflex around the vocal cords. The investigators have developed an approach to reliably block the superior laryngeal nerve by injecting local anesthetic near the nerve in a unique approach. Injecting local anesthetic into or through the thyrohyoid membrane will effectively block the superior laryngeal nerve


Eligibility Criteria:
Inclusion Criteria

1. Patients between the ages of 18-80 requiring an awake intubation for endotracheal intubation.
2. Ability to speak and understand English

Exclusion Criteria

1. Allergy to lidocaine
2. Emergent operative case
3. Therapeutic anticoagulation
4. Mouth opening less than 2 cm
Hyperbaric Oxygen Therapy in Acute Ischemic Stroke Ischemic Stroke Recovery (Pro00061930)

This study will critically examine the feasibility, safety and efficacy of HBOT during inpatient rehabilitation (IPR) after acute ischemic stroke measured by non-disruption of 3 hours of daily therapy, frequency of neurological deterioration or complications (seizure, hemorrhage, brain edema), and functional communication, activities of daily living (ADLs) and mobility.

Preclinical studies support that HBOT augments several adaptive mechanisms following ischemic stroke, including neuroplasticity, cerebral angiogenesis, and regeneration of nerve fibers. The earlier the treatment, the greater potential for a therapeutic effect. However, logistical issues and safety concerns have prevented application of HBOT in the hyperacute window, particularly when coupled with recanalization therapy as the risk of hemorrhagic conversion is highest, monitoring intervals are short, and the natural history is being altered by another treatment. By enrolling patients who are in the subacute phase of stroke who are admitted to an inpatient rehab facility, the risk of HBOT is lower, monitoring intervals are longer, and the selected population has newly acquired and targetable stroke-related disability. Further, the patients are in a supervised setting and available for daily one-hour treatments without disrupting their intensive multidisciplinary rehab plan thereby minimizing nonadherence to daily treatments. Neuroimaging supports that injured, but not dead, brain cells can persist for months after an ischemic event. Hypoxia mediates cellular activity and death through multiple mechanisms. Ongoing decrease in oxygenation to the damaged area due to impaired blood flow works against cellular repair, recovery, and development of new synaptic connections. Increasing oxygen availability has been considered as an obvious treatment for stroke. HBOT has the potential to facilitate the recovery of injured or inactive neurons through increased blood flow and oxygen delivery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and above
* Ischemic stroke proven on neuroimaging
* Within 7-30 days post-stroke on day 1 of treatment
* Admitted to Touro Inpatient Rehab Facility

Exclusion Criteria:

* Pre-stroke modified Rankin Scale Score \>2
* Parenchymal hemorrhagic transformation (PH1 or PH2)
* Receptive aphasia such that recommendations for preventative measures to mitigate barotrauma cannot be followed
* History of recurrent and unprovoked seizures requiring a change in management in the last 3 months to control seizures
* Pulmonary disease requiring supplemental oxygen or daily respiratory medication management (metered dose inhalers, nebulized treatment or steroids)
Capillary-Venous Paired Data Collection

Capillary-venous paired data collection.

An iterative data collection study to continuously assess the performance of our Entia Liberty device with cancer patients. Our device enables a full blood count from a finger prick sample. The participants enrolled in the study will attend the study site for their routine venepuncture blood test. Once enrolled, they will have a finger prick test obtained by a Healthcare Professional (trained member of the clinical research team) to be tested on an Entia Liberty device. Within 4 hours of that same participant's routine venepuncture, a small amount of blood from the venepuncture will be also tested on a second Entia Liberty device in the laboratory. All the results from the capillary finger prick Liberty test, routine venepuncture blood test (gold standard reference method) and the venous blood Liberty test will be compared against each other to regularly assess that the improvements made on the measurement system of the device is sufficient.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old at the time of study entry
* Currently receiving standard of care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and has received at least one cycle of treatment
* Scheduled to be undergoing routine venous laboratory blood tests as part of standard of care
* Can provide written informed consent

Exclusion Criteria:

* History of haematological malignancy
* Inadequate use and understanding of the English language, requiring a translator
Effect of SSP-004184 (SPD602) on the Pharmacokinetics of Simvastatin in Healthy Adult Subjects

This is a randomized, open-label study to evaluate the effect of a single dose of SSP-004184 on the pharmacokinetics of a single dose of simvastatin in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Normal healthy male and female volunteers
* Serum ferritin, hemoglobin and erythrocyte indices within normal range

Exclusion Criteria:

* Evidence of any active or chronic disease
Phase 2 Study Evaluating Mid-position Strategy in Radiotherapy Treatment for Patients With a Locally Advanced Non-small Cell Lung Carcinoma

The purpose of this study is to establish on the market and to clinically evaluate a new strategy of treatment for patients with locally advanced non-small cell lung cancer using deformable repositioning of 4D imaging.


Eligibility Criteria:
Inclusion Criteria:

* patient with a NSCLC, non-resected, non-metastatic including a parenchyma portion
* Age \>= 18 years
* PS \<=2
* CT-scan within 3 months at inclusion
* PET-scan within 3 months at inclusion
* Respiratory functional exploration within 3 months at inclusion
* estimated V20 (by radiotherapist)\< 35% on conventional pre-radiotherapy imaging
* Tumor T0 to T4, M0; N1, N2 ou N3 by isolateral supra-clavicular involvement
* Measurable disease according to RECIST criteria 1.1
* Curative intent Chest conventional radiation therapy
* Radiation indication validated by a multidisciplinary meeting
* Adequate contraceptive method for the whole study duration and for up to 28 days after the end of radiation
* Mandatory affiliation with a health insurance company
* Patients must provide dated \& written consent

Exclusion Criteria:

* Prior surgery for NSCLC
* NSCLC nearby pulmonary apex or strictly intra-thoracic with no intra-parenchyma portion
* Metastatic disease or N3 contralateral lymph node
* History of chest irradiation
* History of known increased intrinsic radiosensibility
* Hypersensibility to active substance or excipient of fluoro-deoxyglucose-18F
* Life expectancy \< 6 months
* Patient with a concurrent malignancy or with a history of malignancy (excepted adequately treated basal cell skin carcinoma or cervical squamous cell carcinoma or other malignancies free of the disease for at least 5 years)
* Pregnant or breastfeeding women
* Psychological, sociological or geographical conditions that would limit compliance with study requirements
* Patient deprived of freedom
* Patient has concomitant participation to an other investigational study
Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide

Postpartum prophylactic HCTZ administration for prevention and relapse of preeclampsia or gestational hypertension.

To evaluate effectiveness of hydrochlorothiazide prophylaxis on prophylaxis, prevention and relapse of preeclampsia or gestational hypertension on readmission rates, need for additional antihypertensive therapy and number of triage visits.

Eligibility Criteria:
Inclusion Criteria:

* Maternal age ≥ 18 years and \<50 years.
* Diagnosis of gestational hypertension\* or preeclampsia\^ at any time during pregnancy, labor or postpartum.

  * defined as isolated systolic BP of 140 mm Hg or greater, a diastolic BP of 90 mm Hg or greater, or both) or \^ defines as new-onset hypertension plus new-onset proteinuria, or in the absence of proteinuria, preeclampsia is diagnosed as hypertension in association with thrombocytopenia (platelet count less than 100,000/microliter), impaired liver function (elevated blood levels of liver transaminases to twice the normal concentration), the new development of renal insufficiency (elevated serum creatinine greater than 1.1 mg/dL or a doubling of serum creatinine in the absence of other renal disease), pulmonary edema, or new-onset cerebral or visual disturbances.)

Exclusion Criteria:

* Subject requiring antihypertensive therapy at time of screening.
* Planned discharge with oral anti-hypertensive medication.
* Contraindication to hydrochlorothiazide (advanced renal failure or anuria, hypersensitivity to sulfonamides).
* Subject not able to follow up postpartum.
* Lactose intolerance.
* Pre-gestational diabetes.
B6 Treatment for Nausea and Vomiting in Pregnancy

The purpose of this study is to determine vitamin B6 concentration and whether vitamin B6 is effective in nausea and vomiting of pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Nausea and vomiting of pregnancy

Exclusion Criteria:

* Other medical condition causing nausea and vomiting of pregnancy
CT-Guided Adaptive Radiation Therapy Combine With Anti-PD-1 Antibody Adjuvant Immunotherapy for Thoracic Cancer Patients

This phase II study is to evaluate the safety and efficacy of CT-based adaptive radiation therapy followed by adjuvant anti-PD-1 antibody immunotherapy in treating patients with different types and stages of thoracic malignancies. (CARTAI)

PRIMARY OBJECTIVES:

I. To evaluate the safety and toxicity of anti-programmed cell death 1 (PD-1) inhibition consolidation therapy after radiation therapy for multiple thoracic malignancies.

SECONDARY OBJECTIVES:

I. To assess the efficacy of adjuvant anti-PD-1 antibody immunotherapy after radiotherapy.

II. To understand the dynamics and interactions of IDO with others immune pathway biomarkers.

III. To evaluate whether IDO immune status could predict the treatment outcomes of radiation and immune combined therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Signed inform consent form
2. Age \>= 18 years and \<= 75 years
3. Histologically or cytologically confirmed advanced/metastatic thoracic malignancies
4. Patients must receive adaptive radiation therapy within 45 days before the first dose of trial treatment
5. Eastern Cooperative Oncology Group performance status of 0 or 1
6. Life expectancy \>= 8 weeks
7. Adequate hematologic and end organ function

Exclusion Criteria:

1. Prior exposure to any immune checkpoint inhibitors including but not limited to anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibodies.
2. Prior exposure to any other thoracic radiation therapy before this time radiation therapy.
3. Prior exposure to steroid therapy or any other form of immunosuppressive therapy within 14 days before the first dose of trial treatment
4. No active second cancers
5. Active or prior autoimmune disease or immunodeficiency.
6. Active infections including but not limited to hepatitis B, C ,and HIV.
7. Significant cardiovascular disease
8. Active or untreated central nervous system (CNS) metastases
9. Any unresolved toxicity CTCAE \>= Grade 3 from the prior radiation therapy.
10. Known hypersensitivity to humanized antibodies or fusion proteins or any of study drug excipients.
11. Known psychiatric or physical impairments that would interfere with cooperation with the protocol of this trial.
Clinical Evaluation of Therapeutic Meibomian Gland Expression

This will be a single centre pilot study to evaluate appearance of the Meibomian glands.


Eligibility Criteria:
Inclusion Criteria:

* Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Be between 18 and 60 (inclusive) years of age at the time of screening. Inclusion Criteria at Baseline Evaluation.
  4. The subject must have visual acuity of 0.2 high contrast logMAR or better in their current correction or unaided in each eye.
  5. The subject must have at least 10 Meibomian glands yielding liquid secretion (MGYLS) in central lower eyelid region in each eye.
  6. The subject eyelids must be easy to evert, at the Investigator's discretion.

     Exclusion Criteria:
* Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Be currently pregnant or breastfeeding.
  2. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus \[HIV\]), autoimmune disease (e.g., rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See Section 9.1 for additional details regarding excluded systemic medications.
  3. Have any known hypersensitivity or allergic reaction to any of the known ingredients in the anesthetic (proxymetacaine hydrochloride) or sodium fluorescein.
  4. Have a history of cardiac disease or hyperthyroidism.
  5. Have had any previous ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, cataract etc.)
  6. Have participated in any ophthalmic clinical trial within 14 days prior to study enrolment.
  7. Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
  8. Have a history of amblyopia or strabismus.
  9. Have a history of contact lens wear. A trial period (up to one week) in the past is allowed.
  10. Wear eye makeup on the days of the study visits.
  11. Have clinically significant (grade 3 or higher on the Efron grading scale) slit lamp findings (e.g., corneal edema or neovascularization, conjunctival or limbal redness) or any other abnormality which would normally contraindicate participation in the study.
  12. Have any ocular infection.
  13. Have central lower eyelid Meibomian gland atrophy that exceeds 25%.