cyrilzakka/clinical-trials huggingface dataset:
RGB(Red- Green-Blue) Measurement of the Nasal Mucosal Image

The aim of this study was to evaluate the color values of the nasal mucosa, which is easily assessable by a direct, non-invasive, objective photographic measurement, for the purpose of presenting a diagnostic objective parameter of allergic rhinitis (AR).

All patients and controls were examined by the same 4 mm 0⁰endoscope and light source, and all endoscopic photographs of the septum and both inferior turbinates were taken. Adobe Photoshop Elements 7.0 program was used to measure the numerical values of the red-green-blue (RGB) color components in endoscopic photographs of the nasal mucosa on the septum and inferior turbinates.

This study enrolled 73 patients with AR (Group 1) and 73 normal healthy individuals(Group 2) with no nasal pathologies and respiratory tract infection attending to the outpatient clinic of the tertiary referral center. Patient's symptoms were questioned and noted by using Lebel Symptom Score Scale. Clinical examination was also done to help diagnose and exclude acute respiratory tract infection. All of the patients had positive skin prick test results for at least one of the most common aeroallergens. All patients and controls were examined by the same 4 mm 0⁰endoscope and light source, and all endoscopic photographs of the septum and both inferior turbinates were taken. Each image was marked with standardized points at the anterior part of the nasal mucosa on both sides (2 points each right and left sides of the anterior septum and 2 points each anterior part of the inferior turbinates). These points were numbered 1 and 2 over the right inferior turbinate; 3 and 4 over the right side of the anterior septum; 4 and 5 over the left inferior turbinate; 6 and 7 over the left side of the anterior septum. Adobe Photoshop Elements 7.0 program was used to measure the numerical values of the red-green-blue color components in endoscopic photographs of the nasal mucosa on the septum and inferior turbinates.

Eligibility Criteria:
Inclusion Criteria:

* Subject has positive skin prick test results
* Subject has more than 5 points of Lebel Symptom Score Scale
* Subjects between 18-60 ages
* Subjects with allergic rhinitis

Exclusion Criteria:

* Negative skin prick test results
* Acute respiratory tract infection existence
* Scores less than 5 points of Lebel Symptom Score Scale
Randomized Controlled Trial of Cognitive Therapy Based Self Help Manual for Depression

While CBT (Cognitive Behaviour Therapy)has been found to be effective in treating depression in West, only limited amount of research has been conducted to find assess its effectiveness in low and middle income countries. We have developed culturally sensitive CBT during the last few years in Pakistan. Pakistan has high rates of depression. And there is currently a need to develop and test evidence based treatments which are culturally sensitive and cost effective. IN this project we will be assessing the effectiveness of a culturally sensitive CBT based self help intervention for depression in Pakistan against care as usual, using a randomized controlled design.


Eligibility Criteria:
Inclusion Criteria:

* All those who fulfil the diagnosis of Depressive episode (F32) or Recurrent depressive disorder (F33 except 33.4 ) using ICD10 RDC (International Classification of Diseases, Research Diagnostic Criteria), scored 8 or more on HADS (Hospital Anxiety and Depression Scale) Depression Sub-scale, are between the ages of 18-60 and either patient or the carer has at least 5 years of education.

Exclusion Criteria:

* The exclusion criteria include; excessive use of alcohol or drugs (using ICD 10 RDC for alcohol or drug abuse or dependence) significant cognitive impairment (for example learning disability or dementia) and active psychosis.
The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) on QT Intervals in Healthy Volunteers

The purpose of this study is to examine the effect of buprenorphine on QT interval corrected for heart rate (QTc) in healthy subjects.

Drugs in this opioid class have been associated with prolonging QT interval/QT interval corrected for heart rate (QTc).

Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 to 55 years of age, inclusive.
* Body weight ranging from 50 to 100 kilograms (kg) and a body mass index (BMI) ≤ 30 kg/m2.
* Healthy as determined by unremarkable medical history, physical examination, vital signs, laboratory evaluations, electrocardiogram (ECG), and a 24-hour screening ECG telemetry.
* Willing to refrain from strenuous exercise or contact sports during the study.
* Female subjects must be surgically sterile or at least 2 years postmenopausal, or using an effective contraceptive method (intrauterine device, hormonal contraceptive, or double-barrier method).

Exclusion Criteria:

* Any clinically significant illness during the 30 days prior to randomization.
* Any history of allergy to buprenorphine, any excipient of BTDS, opioids, psychotropic or hypnotic drugs, and/or moxifloxacin or any member of the quinolone class of drugs.
* A clinically significant history of allergic reaction to wound dressings or bandages.
* Any medical or surgical conditions which might interfere with drug absorption (transdermal or gastrointestinal), distribution, metabolism, or excretion.
* Abnormalities on physical examination, vital signs, ECG, or clinical laboratory values, unless those abnormalities are judged to be clinically insignificant by the Investigator.
* Any cardiovascular disorders, including hypertension.
* Oxygen saturation (SpO2) ≤ 94% as measured by pulse oximetry.
* Any personal or family history of prolonged QT interval or disorders of cardiac rhythm.
* Abnormal cardiac condition denoted by any of the following:
* QT interval ≥ 450 milliseconds (msec).
* PR interval \> 240 msec or ≤ 110 msec.
* Evidence of second- or third-degree atrioventricular (AV) block.
* Pathological Q-waves (defined as Q-wave \> 40 msec or depth \> 0.5 mV).
* Evidence of ventricular preexcitation, complete left bundle branch block, right bundle branch block (RBBB), or incomplete RBBB.
* A resting heart rate outside the range of 50 to 85 beats per minute (bpm).

Other protocol-specific exclusion/inclusion criteria may apply.
SENOC-I Det Sunda Huset II - Sensitization of Occupants of Water Damaged Buildings.

The study is focussed on two main questions:

1. The importance of dampness of the building and home dust as a factor of the subjects= responses.
2. Can measures used in KLINIR predict the subjects' responses to the dust?

This study therefore was arranged to test the following hypotheses:

1. Does dust in general cause inflammatory/body perceptions through e.g. an irritation symptoms index.
2. Does the dust include effective odorants which affects an IAQ index?
3. Does dampness increase the content of organic or inorganic compounds e.g. of microbial origin that causes the dust to be more reactive? (Differences between the two types of dust)
4. Is the sensitivity of the subjects explaining the responses to exposures in a, b, or c? (Subject group and sensitivity index)

As explorative investigations biomarkers for exposures and sensitivity for practical usage are tested.

The study is focussed on two main questions:

c. The importance of dampness of the building and home dust as a factor of the subjects= responses.

d. Can measures used in KLINIR predict the subjects' responses to the dust?

As explorative investigations biomarkers for exposures and sensitivity are tested for practical use.

These investigations are made during experimental exposures of subjects to dust from dry and water damaged buildings. The responses of healthy KLINIR-sensitive subjects are predicted using personal sensitivity measures.

The design is a 3x3 Latin square design (cross-over design). The subjects will be their own controls and comparisons to placebo (clean air) were made. The study was double blinded and the subjects were only informed about details on design and exposures after the experiment and only if they asked.

This design eliminated effects of any learning or training during the investigations, and also the effects of season and weekday was eliminated. The subjects were exposed with 3-4 weeks interval to eliminate carry-over of effects from one exposure session to the next.

The design was replicated three times on three different groups of subjects each including 9 subjects. Each group of nine were divided into three groups of three subjects.

Eligibility Criteria:
Inclusion Criteria:

* All in local area, nasal histamine responsive, grass allergic, from study KLINIR.

Exclusion Criteria:

* Pregnancy, house dust allergy, hyper-responding air ways, disease, disabled
Microneedle Patch With Botulinum Toxin in Management of Enlarged Facial Pores

The purpose of this study is to assess the efficacy and safety of microneedle patch with botulinum toxin for improving enlarged pores.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old and concerned about enlarged pores
* Have pore size 0.3-0.6 mm
* Have pore parameter in each other side of faces not different more than 5%

Exclusion Criteria:

* Any neuromuscular condition
* Pregnancy or breast feeding
* History of allergy : Botulinum toxin, topical anesthesia
* History of keloid or hypertrophic scar
* History of coagulation or receiving medication that causes coagulation disorder
* Using drugs that have interaction with Botulinum toxin
* Using topical medication that improves enlarged pores in 1 month
* Taking medication that improves enlarged pores in 1 month
* Receiving the laser/treatment/chemical peeling in 6 months
EUS-CPN: A Retrospective Review

The purpose of this retrospective study is to measure the safety of EUS-CPN in patients that have undergone this procedure in the last decade.


Eligibility Criteria:
Inclusion Criteria:

* Any subject that has undergone EUS-CPN will be considered for this study.

Exclusion Criteria:

* Subjects will be excluded if they have undergone a celiac plexus neurolysis (endoscopic, percutaneous, or surgical) at an another institution.
Measuring Alterations of DNA in Human Blood

The purpose of this research is to evaluate an automated, laser-based technique for measuring DNA damge resulting from radiation. We want to use controlled exposure on cancer patients to help develop a measurement to test people who may have been accidentally exposed to radiation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 21 to 70 years old.
* Patient undergoing with anti-neoplastic agent(s) known to have genotoxic activity (e.g., cyclophosphamide, 5-FU, cisplatin, Ara-C.
* X-irradiation may be considered, so long as a substantial fraction of red marrow is exposed (e.g., femur or chest/trunk region);
* treatment could be ongoing therapy or initial therapy.
The HALT Biomarker Study

The purpose of the HALT Biomarkers study are to identify a panel of circulating proteins that discriminates between patients with and without Hypo-Attenuated Leaflet Thickening (HALT) and can be used to supplement the diagnosis of HALT; to characterize changes in circulating proteins after treatment of HALT with systemic anticoagulation; and to identify circulating proteins that predict the occurrence of HALT.

The study population will be adult patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) or bioprosthetic valve degeneration. Enrollment will continue until 30 patients with HALT are identified for completion of phase 1. Based on a HALT incidence rate of 10%, we anticipate enrolling 300 patients.

Patients are enrolled prior to undergoing transfemoral TAVR. Blood samples, clinical data and echocardiograms will be collected at the following timepoints: baseline (pre-TAVR, T0), post-TAVR (pre-discharge, T1), 30-day follow-up (window 3-9 weeks, T2), and 6-month follow-up (T3). Cardiac 4D CT will be performed at the 30-day follow-up visit to screen for the occurrence of HALT.

Patients with HALT will be treated with systemic anticoagulation for 5-6 months, at which point a follow-up CT scan and blood sample will be obtained. Control subjects will also undergo a 6-month study visit with blood sample collection. The study will be conducted within two phases. Phase 1 will serve as a derivation / discovery study in which candidate protein biomarkers of HALT will be identified.

Once this is successfully completed, a second cohort will be enrolled within phase 2. Phase 2 will be performed under the auspices a future contract or amendment and will seek to cross-validate the initial study findings.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 65 years
2. Subject with severe native AS or severe bioprosthetic valve degeneration
3. Subject undergoing transfemoral TAVR using a Medtronic Evolut R, Evolut Pro or Evolut Pro+ transcatheter heart valve

Exclusion Criteria:

1. Chronic anticoagulation therapy
2. Contraindication to systemic oral anticoagulation therapy
3. Chronic kidney disease with EGFR\<30 ml/min
4. Bleeding diathesis or known coagulopathy
5. Hypercoagulable state
6. Life-expectancy \<12 months due to other medical conditions (e.g., malignancy, severe Alzheimer's disease, etc.)
7. The patient is currently participating in another investigational device or drug study that has not reached its primary objective/endpoint
8. Pregnant, lactating, or planning pregnancy within next 12 months
Veliparib in Combination With Gemcitabine and Intensity Modulated Radiation Therapy in Patients With Pancreatic Cancer

This is a Phase I Study of veliparib (ABT-888) in combination with Gemcitabine and Intensity Modulated Radiation Therapy in Patients with Locally Advanced, Unresectable Pancreatic Cancer.

Primary Objectives:

* Determine the maximum tolerable dose of veliparib in combination with gemcitabine and intensity modulated radiation therapy in patients with locally advanced pancreatic cancer.
* Determine the safety and toxicity of the combination of veliparib with gemcitabine and radiation therapy in patients with locally advanced pancreatic cancer

Gemcitabine will be administered by intravenous infusion of 1000 mg/m2 over 30 minutes on days 1, 8, 15 of the cycle. Intensity modulated radiation therapy (IMRT) will be given to a total dose of 36 Gy in 15 fractions (2.4 Gy per fraction, one fraction per day, 5 fractions per week, Monday through Friday) beginning on day 1. Veliparib will be administered per a dose escalation schema. The starting dose of veliparib is 20 mg BID based upon safety/efficacy data available. Dose escalation will continue in 20 mg increments until the maximum tolerated dose (MTD) is reached. Intra-patient dose escalation will not be allowed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histopathological or cytological diagnosis of adenocarcinoma of the pancreas, as well as those with high clinical suspicion of adenocarcinoma, which is deemed locally advanced unresectable or borderline resectable as determined by a pancreatic cancer surgeon and/or following evaluation by a GI oncology tumor board.
* Age 18 years or older

Exclusion Criteria:

* Patients who have had prior anti-cancer treatment for their disease
* Patients who are currently receiving any other investigational agents
* Metastatic disease
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to PARP \[Poly (ADP-ribosome) polymerase\] inhibitors or gemcitabine
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Fingolimod in Endovascular Treatment of Ischemic Stroke

Proof-of concept clinical trials have indicated that the sphingosine-1-phosphate receptor modulator fingolimod may be efficacious in attenuating brain inflammation and improving clinical outcomes in patients with acute ischemic stroke as a single therapy beyond 4.5 hours of disease onset, or in combination with alteplase within 4.5 hours of disease onset. This study aim to determine whether fingolimod enhance the action of endovascular treatment for acute ischemic stroke


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with anterior circulation acute ischaemic stroke who are eligible for mechanical thrombectomy commenced within 6-24 hours of stroke onset.
* Patient, family member or legally responsible person depending on local ethics requirements has given informed consent.
* Patient's age is 18-80 years.
* Arterial occlusion on internal carotid artery proximal or middle cerebral artery
* Imaging inclusion criteria: infarct core volume between 15-70 mL

Exclusion Criteria:

* Pre-existing neurologic disability (a score greater than 2 on the mRS).
* Swallowing difficulties that would prevent administration of oral fingolimod.
* Patients with any history of bradyarrhythmia, atrioventricular block or current use of beta-blockers or verapamil.
* Patients with serious acute or chronic infection, or hepatic injury
* Concomitant use of antineoplastic, immunosuppressive or immune modulating therapies.
* Macular edema.
Study of SPG302 in Healthy Volunteers and ALS Participants

The first-in-human Phase 1 study described herein will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPG302 in healthy volunteers and ALS participants

This study is a Phase 1 randomized, double-blind, placebo-controlled, single, and multiple ascending dose study in HV with food effect cohort, and a repeat dose expansion cohort(s) in participants with ALS.

The study consists of 3 parts, as follows:

* Part 1: SAD in HV with up to 6 cohorts including a food effect cohort.
* Part 2: MAD over 5 days in HV with up to 5 cohorts
* Part 3: ALS cohorts with once daily (QD) dosing over 28 day cycles

Eligibility Criteria:
Inclusion Criteria:

* Age 18-55
* Must be in good health with no significant medical history
* Clinical laboratory values within normal range or \< 1.2 times ULN
* BMI 18-32 (inclusive)
* Contraceptive use by men or women consistent with local regulations
* Able and willing to provide written informed consent

Exclusion Criteria:

* Any physical or psychological condition that prohibits study completion
* Known cardiac disease
* Active or history of malignancy in the past 5 years
* Serious infection within 1 month of screening
* Acute illness within 30 days of Day 1
* Surgery, bone fracture, or major musculoskeletal injury in the past 3 months
* History of suicidal behavior or suicidal ideation
* Active cigarette smokers and users of nicotine-containing products
* HIV, hepatitis B and hepatitis C positive
* SBP \>140 or \<90
* DBP \>90 or \<40
* HR \<40 or \>100
* QTcF \>450ms, cardiac arrhythmia, or clinically significant abnormal ECG
* Prescriptions, over-the-counter, or herbal medication within 7 days
* Vaccines within 14 days
* Other investigational products within 30 days
* Blood donation within 30 days
* Plasma donation within 7 days
* Pregnant or breastfeeding
* Otherwise unfit, on metabolic-altering lifestyle/diet, positive urine drug screen or intake of alcohol or caffeine-containing products

ALS Cohort Inclusion Criteria:

* Age 18-80
* ALS TRICALS risk score
* Stable dose of standard of care treatment
* Contraception use by men or women consistent with local regulations
* Able and willing to provide written informed consent

ALS Cohort Exclusion Criteria:

* Underlying physical or psychological condition prohibiting study completion
* Known cardiac disease
* Active or history of malignancy in the past 5 years
* Serious infection within 1 month of screening
* Acute illness within 30 days of Day 1
* History of suicidal behavior or suicidal ideation
* Active cigarette smokers and users of nicotine-containing products
* Neurodegenerative disease
* External respiratory support or supplemental oxygen requirement
* HIV, hepatitis B and hepatitis C positive
* SBP \>140 or \<90
* DBP \>90 or \<40
* HR \<40 or \>100
* QTcF \>450ms, cardiac arrhythmia, or clinically significant abnormal ECG
* Vaccines within 14 days
* Other investigational products within 30 days
* Blood donation within 30 days
* Plasma donation within 7 days
* Pregnant or breastfeeding
* Otherwise unfit
Anti-Aggregative Therapy and Laser Iridectomy

Our study investigates the effect of anti-aggregative treatment on success and complications of laser iridectomy. The study includes patients scheduled for laser iridectomy due to narrow angles.Patients will undergo first laser treatment with the anti-aggregative treatment and will scheduled for next lase in the other eye after discontinuing the anti-aggregative treatment. The patients will be followed-up for 3 months.


Eligibility Criteria:
Inclusion Criteria:

* patients with narrow angle that need laser iridectomy and take anti- aggregative treatment
* over 20 years old
* patients who can stop their anti-aggregative treatment for 10 days

Exclusion Criteria:

* under coumadin treatment
* post ocular surgeries
Clinical and Molecular Biological Data Collection and Analysis in Patients With TBI

Clinical evaluation is crucial in the clinical diagnosis, treatment, and prognosis prediction in patients with traumatic brain injury (TBI). However, the existing evaluation systems are not perfect, because many factors are not taken into account, for example, there is a lack of molecular diagnostic criteria for evaluating patients with TBI. We attempt to collect the patient's clinical data and combine it with neuroimaging, as well as molecular biomarkers generated by single-cell sequencing to assess their neurological status and outcome. The clinical and molecular data collection and analysis will be helpful to evaluate the patient's neurological condition and predict the patient's outcome more accurately.

Specifically, eligible patients will be treated surgically. In one group, injured brain tissue removed during decompression and resection will be preserved in a tissue preservation solution. In another group, brain tissue in the surgical trajectory during surgical resection of the brain lesion (for example, gliomas, meningiomas, schwannomas) will be also preserved in the solution. Then these tissues will be analyzed through high-throughput single-cell sequencing and bioinformatics analysis. In order to obtain the most changed biomarkers, we will pick up the top 10 cell subgroups with 10 expression biomarkers in each subgroup to compare them with the results analyzed in the mice brain tissue. The target biomarkers will be validated in the cerebrospinal fluid (CSF) and blood in patients with TBI for the patient's neurological status evaluation and outcome prediction. At the same time, the patient's pre- and postoperative clinical data (including, gender, age, GCS score, pupil light reflection, CT results, etc) will also be collected. A regression model will be generated to estimate the relationship between the patient's neurological status and these independent variables. In addition, the association between a patient's prognosis and these factors will also be analyzed. ROC curve will be used to compare our regression model to the established GCS score scale and Marshall CT grading.

Eligibility Criteria:
Inclusion Criteria:

* CT/MRI confirmed TBI;
* The time from onset to the emergency room (ER ) within 12h;
* The systolic pressure (SBP) ≥ 90 mmHg;
* Patients willing to participate in this study with signed informed consent.

Exclusion Criteria:

* Patients who are not suitable for surgery (GCS score 3 points, dilated and fixed bilateral pupils, pregnant women, etc.);
* Pre-injury life expectancy ≤ 1 year (malignant tumor);
* Previous history of acute myocardial infarction, abnormal immune function, and blood-related diseases;
* without informed consent.