cyrilzakka/clinical-trials huggingface dataset:
Measures of Respiratory Health Registry

There are many techniques that can allow for the quantification of lung function in children; some are being used clinically and others are under development. Many of these tools are available at BC Children's Hospital. This registry study will act as a central repository for the results of traditional and novel pulmonary function tests done at BC Children's Hospital to allow for future analysis.

The scope of the registry is to collect data on small airways function in healthy children, children with cystic fibrosis (CF) and children with non-CF respiratory disease using the multiple breath washout (MBW) system. These data will be stored along with demographic data, clinical data, and traditional pulmonary function testing (PFT) data. The MBW data will be collected with concurrent with clinically indicated PFT testing.

The purpose of the registry is to 1/ establish a locally collected normal range of small airways function across the paediatric age range and 2/ to collect these measurements in CF and non-CF respiratory disease.

Ultimately, the objective of this registry is to validate MBW technology as a tool that can be utilized in clinical care.

Eligibility Criteria:
Participants with CF

Inclusion Criteria:

-Diagnosis of CF as evidenced by one or more clinical feature consistent with the CF phenotype or positive CF newborn screen AND one or more of the following criteria: i. A documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis (QPIT).

ii. A documented genotype with two disease-causing mutations in the CFTR gene.

- In the opinion of the investigator, the participant will likely have the ability to perform the lung function test of interest on the day of testing

Exclusion Criteria:

* Physical findings at the screening that would compromise the safety of the participant or the quality of the data (e.g. respiratory distress or work of breathing)
* Requirement of supplementary oxygen to maintain oxygen saturation above 95%

Participants with other Respiratory Disease

Inclusion criteria:

* Physician-diagnosed lung disease
* Informed consent by participant, parent, or legal guardian
* In the opinion of the investigator, the participant will likely have the ability to perform the lung function test of interest on the day of testing

Exclusion criteria

* Physical findings at screening that would compromise the safety of the participant or the quality of the research data
* Requirement of supplementary oxygen to maintain oxygen saturation above 95%

Healthy Participants

* Inclusion criteria
* Informed consent by participant, parent, or legal guardian
* In the opinion of the investigator, the participant will likely have the ability to perform the lung function test of interest on the day of testing

Exclusion criteria

* Physical findings at screening that would compromise the safety of the participant or the quality of the research data
* Evidence of lung disease
Correlation Between the Change in the Antero-posterior Diameter of the Pelvic Side and the Incidence of Post-partum Urinary Incontinence

During pregnancy, the strength of the pelvic floor muscles may decrease, which can lead to musculoskeletal changes that may facilitate the onset of urinary incontinence. The investigators decided to conduct this study firstly to analyze, through simple ultrasound indices, how the contractile capacity of the pelvic floor muscles affects postpartum urinary incontinence; secondly to study the correlation between the use of perineal gymnastics, the incidence of postpartum urinary incontinence, and the strength of floor contraction.

As part of the gynecologic ultrasound that is routinely performed, a transperineal scan will be performed, at rest and during maximal contraction to measure the lower portion of the pelvic floor groove. I order tho achieve this, doctors will illustrate to participants first verbally and then with the visual aid of the ultrasound monitor, how to contract the pelvic floor muscles. Transperineal ultrasound is performed by placing the ultrasound probe covered by a sterile glove at the level of the labia majora. Such ultrasound does not involve internal investigations and is in no way painful. The duration of the additional ultrasound scan involves a few minutes. In addition, in order to assess the presence of typical symptoms of urinary incontinence, the participant will undergo a standardized validated questionnaire in the Italian language, called ICIQ-UI SF, consisting of a series of questions that will investigate the type of urinary incontinence, its severity and its impact on her quality of life in the four weeks prior to administration. After delivery, the participant's medical records will be consulted and some data regarding the participant (age, ethnicity, height, weight, BMI, parity, gestational age at the time of delivery), the delivery (duration of stage II labor, mode of delivery, any vagino-perineal laceration and its degree) and the newborn (weight and head circumference measurement) will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* age of 18 years or older
* completion of delivery by vaginal delivery, vaginal delivery with obstetric suction cup or cesarean section
* acquisition of informed consent form

Exclusion Criteria:

* presence of severe maternal complications (e.g., ongoing postpartum hemorrhage, severe sepsis, pulmonary embolism, heart failure).
* presence of clinically demonstrable vulvar or vaginal infection
Using Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission Tomography To Detect Hypoxia in Head and Neck Cancer Patients

The main purpose of this study is to evaluate low oxygen areas called hypoxia within tumors. These low oxygen areas are thought to be the reason why tumors are more resistant to chemotherapy and radiation treatment.

An imaging technique using a hypoxia tracer called fluoromisonidazole (FMISO) can detect low oxygen areas within a tumor. This imaging technique, called a PET scan, uses positively charged particles to detect slight changes in the body's biochemistry and metabolism. FMISO PET scans have been performed in patients with head and neck cancer and have shown the ability to detect low oxygen areas within tumors.


Eligibility Criteria:
Inclusion Criteria for Cohort 1 and Cohort 2 :

* Histologically confirmed diagnosis of head and neck carcinoma (excluding nasopharynx, paranasal sinus, salivary, and thyroid malignancies)Any unknown primary squamous cell carcinoma of head and neck with gross nodes is allowed (2002 AJCC)
* 18 years of age or older
* Must not have received prior radiation therapy or chemotherapy for this diagnosis. Patients who have had their primary site tumor removed by surgery but still present with grossly enlarged lymph nodes are eligible for this study.
* Karnofsky performance status ≥ 70.

Exclusion Criteria for Cohort 1 and Cohort 2:

* all nasopharyngeal, paranasal sinus, salivary cancer, and thyroid malignancies
* prior chemotherapy or radiotherapy within the last three years
* patients that underwent previous surgical resection for the same disease (except for biopsy or surgery removing primary site tumor but still present with grossly enlarged lymph nodes)
* any prior radiotherapy to the head and neck region
* pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding

Subject Exclusion Criteria for Optional Contrast MRIs

• Subjects with a known contraindication to the standard MRI contrast agent (Gadavist, a gadolinium-based contrast agent) and/or a recent estimated glomerular filtration rate (eGFR) of 30 or less will be excluded from all DCE-MRIs, and will instead receive non-contrast MRIs at the DCE-MRI time points.
Blocks for Intertrochanteric Fracture Repair Surgery

This single-center open label study compares the outcomes of surgical repair of intratrochanteric fracture under general anesthetic or peripheral nerve blocks.

This single-center open label study compares the outcomes of surgical repair of intratrochanteric fracture under general anesthetic or peripheral nerve blocks.

Patients are high risk individuals scheduled for intratrochanteric fracture repair, with contraindications to spinal anesthesia. One group will receive general endotracheal anesthetic, the other femoral and lateral femoral cutaneous nerve with deep sedation.

Mortality, morbidity (major cardiovascular incidents,delirium, pneumonia), pain scores and opioid consumption will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* intratrochanteric fracture
* need for surgery
* contraindications for spinal anesthesia

Exclusion Criteria:

* allergy to local anesthetics
A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)

A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis


Eligibility Criteria:
Inclusion Criteria:

* At least a 6-month history of PPP as defined by the presence of pustules on palms and/or soles, but without evidence of infection on palms and soles
* Moderate or severe PPP, as defined by Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI) ≥8 and Palmoplantar Pustulosis Physician Global Assessment (PPPGA) ≥3 at Day -1, and a minimum of 8 fresh pustules at screening (fresh pustule count on both right/left palms and soles) and 20 fresh pustules at Day -1 (fresh pustule count on both right/left palms and soles)
* Males and females must be willing to use birth control as indicated

Exclusion Criteria:

* Moderate to severe psoriasis, as defined by plaque psoriasis covering ≥10% of total Body Surface Area (BSA) at Day -1
* Subject is known to have an immune deficiency or is immunocompromised
* Positive test for hepatitis, human immunodeficiency virus (HIV) or tuberculosis
* Use of topical therapies for PPP within 2 weeks of Day -1 and/or systemic therapies for PPP within 4 weeks
An Exploratory Study of Ganglioside GM1 in Acute Ischemic Stroke

The purpose of this study was to evaluate the efficacy and safety of higher doses of monosialoganglioside GM1 injection in the treatment of patients with acute ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age: 18-80 years old；
* 2. Patients with anterior circulation cerebral infarction;
* 3. first stroke onset or past stroke without obvious neurological deficit (mRS score≤1)；
* 4. Within 24 hours of onset；
* 5. 5 ≤NIHSS score ≤ 20；
* 6. Signed informed consent.

Exclusion Criteria:

* 1. Patients with hereditary abnormal glucose and lipid metabolism (gangliosidosis, such as Tay-Sachs disease and retinal degeneration);
* 2. Hemorrhagic stroke;
* 3. Disturbance of consciousness (NIHSS1a≥1)，or cerebral arteritis, brain tumor, brain trauma, intracranial infectious diseases;
* 4. Planed endovascular treatment;
* 5. Uncontrolled hypertension: systolic pressure ≥200 mmHg or diastolic pressure ≥110 mmHg;
* 6. Bleeding tendency (except for thrombolysis) or severe bleeding within 3 months;
* 7. Patients with malignant tumor or serious diseases;
* 8. Along with epilepsy, arthritis and other disease, which have effect on neurological assessment;
* 9. History of autoimmune diseases, spinal trauma, various demyelinating diseases, including acute inflammatory demyelinating polyneuropathy (Guillain Barre syndrome);
* 10. Unable or unwilling to cooperate due to mental diseases;
* 11. Abnormal liver and renal function: ALT, AST \> 2 times of the upper limit of normal value, or Cr \> 1.5 times of the upper limit of normal value；
* 12. Hypersensitivity to monosialoganglioside and excipients of test drug;
* 13. History of drug abuse；
* 14. Pregnant or lactating women, pregnant plan or unwilling to use effective contraception during the trial period;
* 15. Participating in other clinical trials within 3 months;
* 16. Other conditions which are unsuitable for this trial assessed by researcher.
A Pilot Randomized Controlled Trial of Financial Incentives, Text Messaging, and Usual Care for Homeless Smokers

The QUIT (Quitting with Usual Care, Incentives, and Technology) Smoking Study is a 3-arm pilot randomized controlled trial that will test the effect of 2 different experimental smoking cessation interventions relative to a control condition in homeless cigarette smokers. All participants will receive free transdermal nicotine patches and weekly in-person smoking cessation counseling. In addition, participants randomized to the first experimental condition will receive financial rewards for biochemically-verified smoking abstinence, and participants randomized to the second experimental condition will be enrolled in a text messaging program to support smoking abstinence.


Eligibility Criteria:
Inclusion Criteria:

* Proficient in English, assessed with items asking about native language and self-reported comfort communicating in English among non-native speakers.
* Age ≥18 years old, assessed by self-report and verified by date of birth.
* Has smoked ≥100 cigarettes and currently smokes ≥5 cigarettes per day, verified by an exhaled carbon monoxide level of ≥8 ppm.
* Ready to try quitting smoking within the next month.
* Currently homeless, assessed by self-report and defined as usually staying in an emergency shelter, transitional shelter, abandoned building, place of business, car or other vehicle, church or mission, hotel or motel, or anywhere outside during the past 7 days. Additionally, individuals will be considered currently homeless if they usually stayed in somebody else's house, apartment/condominium, or room in the past 7 days because of not having their own place to stay.

Exclusion Criteria:

* Currently pregnant, assessed by a urine pregnancy test conducted on all premenopausal biologic females who have not had a hysterectomy, or planning to become pregnant in the next 2 months.
* Past 30-day use of nicotine replacement therapy, bupropion, or varenicline for smoking cessation, assessed by self-report. Use of bupropion for reasons other than to quit smoking (e.g. depression) is permissible.
* Prior serious adverse reaction to the nicotine patch, defined as any reaction that was life-threatening or required hospitalization.
* Heart attack or chest pain within the past 2 weeks.
* Inability to read a sentence written at a Flesch-Kincaid grade level of 4.
* Inability to provide informed consent, assessed with knowledge questions about the material presented during the informed consent process that individuals must correctly answer before providing informed consent to participate.
Artificial Tears Versus Preservative Free Ketorolac Trometamol 0.45% for Acute Viral Conjunctivitis

The purpose of this study is to evaluate the evolution of the symptoms of acute viral conjunctivitis using preservative free ketorolac trometamol 0.45% associated with carboxymethylcellulose compared with isolated use of preservative-free artificial tears.

The purpose of this study is to evaluate the evolution of the symptoms of acute viral conjunctivitis using preservative free ketorolac trometamol 0.45% associated with carboxymethylcellulose compared with isolated use of preservative-free artificial tears. A randomized double-masked study will include 60 patients divided into two groups: Group 1: using a formulation of ketorolac tromethamine 0.45% associated with carboxymethylcellulose (Acular CMC®, Allergan, Irvine, USA) and Group 0: using artificial tears (Optive UD®, Allergan, Irvine, USA), both drugs without preservatives.

Eligibility Criteria:
Inclusion Criteria:

* Acute conjunctivitis (unilateral or bilateral) for less than two weeks,
* Signs and symptoms consistent with viral conjunctivitis and at least one of the following: preauricular lymphadenopathy, upper tract respiratory infection or recent contact with someone with conjunctivitis

Exclusion Criteria:

* pregnant women
* allergies to non-steroidal anti-inflammatories
* history of seasonal allergic conjunctivitis
* contact lens wearers
* history of ocular herpes infection
* blepharitis
* severe dry eye
* purulent discharge
* defects in the corneal epithelium
Study to Assess the Safety, Tolerability, and Pharmacodynamic (PD) Effects of FRM-0334 in Subjects With Prodromal to Moderate Frontotemporal Dementia With Granulin Mutation

The purposes of this study are to investigate the safety, tolerability, and pharmacodynamics of FRM-0334 in subjects with prodromal to moderate frontotemporal dementia with granulin mutation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ages aged ≥21 and ≤75 years
* Genotyped positive for a FTD-GRN mutation, and aware of it
* Prodromal to moderate FTD-GRN
* Resides in a stable living situation, living at home, senior residential setting, or an institutional setting without the need for continuous (ie, 24-hour) nursing care
* Proficiency (oral and written) in the language in which study-related documents, including the ICF and standardized tests, will be administered
* Able to swallow capsules
* Be in good general health, willing and able to comply with the protocol requirements, and expected to complete the study as designed (in the judgment of the investigator)

Exclusion Criteria:

* Clinically significant abnormalities on physical examination, medical history, ECG, vital signs, laboratory values, or unstable medical or psychiatric illness
* Females who are pregnant, breastfeeding, or planning to become pregnant during the study
The Influence of Lidocaine Volume on Discomfort During Administration of Local Anesthetic

The aim of the study is to find a simple method for pain reduction that can be used in clinical practice when administering digital nerve block with a single subcutaneous injection. It will be investigated whether a smaller volume of lidocaine can decrease pain during injection.

Healthy volunteers will receive a single subcutaneous injection digital nerve block at the base of each ring finger. 2ml 1% lidocaine in one of the fingers, and 1 ml 2% lidocaine in the other. After each injection, the subject will be asked to evaluate the pain on a visual analog scale (0-100 mm). Additionally the sensibility will be tested with a Semmes-Weinstein monofilament, to evaluate if the different methods achieve desired anesthetic effect.

Eligibility Criteria:
Inclusion Criteria:

* age 18 - 65

Exclusion Criteria:

* regular use of analgesics
* known hypersensitivity of local anaesthetic
* renal-, heart- or liver disease
* known peripheral neuropathy or diabetes mellitus
* local infection on injection site
* circulation disorders in upper extremities (e.g. Raynaud´s phenomenon)
Study to Evaluate the Efficacy and Safety of GSK239512 in Schizophrenia

This study aims to evaluate the cognitive enhancing effects and tolerability of GSK239512 compared to placebo in patients with schizophrenia

This is a 7-week, Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group design study in male and female subjects with schizophrenia who are stabilised on antipsychotic medication. Subjects will be randomised to receive either GSK239512 or placebo for 7 weeks. They will undergo weekly review of safety, tolerability and cognitive performance measures.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of Schizophrenia
2. No acute exacerbation of symptoms requiring hospital admission or step up care in the previous six months.
3. Not on any symptomatic treatment for cognition

Exclusion Criteria:

1. Poses a significant homicidal or suicidal risk or evidence of previous homicidal or suicidal risk.
2. Co-morbid psychiatric or significant physical illness
3. Alcohol or drug abuse or dependence.
BEMPEG With Pembrolizumab vs Pembrolizumab Alone in Patients With Metastatic or Recurrent HNSCC (PROPEL-36)

This is a multicenter, randomized, open-label, Phase 2/3 study that will evaluate the efficacy and safety of bempegaldesleukin (BEMPEG; NKTR-214) combined with pembrolizumab compared with pembrolizumab monotherapy in patients with recurrent or metastatic HNSCC with positive PD-L1 expression (CPS ≥ 1).


Eligibility Criteria:
Inclusion Criteria:

* Provide written, informed consent to participate in the study and follow the study procedures.
* Male or female patients, age 18 years or older at the time of signing the informed consent form (ICF).
* Have histologically or cytologically-confirmed recurrent or metastatic HNSCC that is considered incurable by local therapies.

  * No prior systemic therapy for recurrent or metastatic disease.
  * The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
  * Patients may not have a primary tumor site of nasopharynx (any histology) and/or unknown primary.
* Have measurable disease based on RECIST 1.1 as determined by the local site Investigator.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Measure Description: GRADE - ECOG PERFORMANCE STATUS

0 - Fully active, able to carry on all pre-disease performance without restriction

1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work

2- Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours

• The tumor must have positive PD-L1 expression (i.e., CPS ≥1)

Exclusion Criteria:

* Has disease that is suitable for local therapy administered with curative intent.
* Has progressive disease within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
* Has had radiation therapy (or other non-systemic therapy) within 2 weeks prior to initiation of study drug
* Has a life expectancy of less than 3 months and/or has rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) as determined by the Investigator.
* Has a known additional malignancy that is progressing or has required active treatment within 5 years prior to the first dose of study drug
* Has an active autoimmune disease that has required systemic treatment in the past 2 years
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy
* Use of an investigational agent or an investigational device within 28 days before the first dose of study drug.
* Prior treatment with an anti PD-1, anti PD-L1, anti-PD-L2, or anti CTLA-4 antibody, agents that target IL-2 pathway, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.

NOTE: Other protocol defined inclusion/exclusion criteria may apply