cyrilzakka/clinical-trials huggingface dataset:
Evaluation of an Investigational Multi-Purpose Disinfecting Solution for the Care of Silicone Hydrogel Soft Contact Lenses

The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution in patients wearing silicone hydrogel soft contact lenses.


Eligibility Criteria:
* Successful daily wear of Night \& Day® or Acuvue® Advance™ silicone hydrogel contact for at least two weeks.
* Use of AOSEPT® ClearCare™ only as the pre-study care regimen for at least two weeks (rewetting drops use is also acceptable).
* Successful lens wear for at least 8 hours per day.
* Vision correctable to 20/30.
* Normal eyes - no current ocular abnormalities that prevent successful contact lens wear.
* No corneal surgery within the past 12 months.
* No systemic disease that affects that eye or that could be worsened by the use of contact lenses or solutions.
* No over-the-counter or prescription ocular medication.
* No enrollment in another clinical study within 30 days prior to enrollment.
CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Hematological Malignancies

A Study of CD19/BCMA-targeted CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia, B-cell Non-Hodgkin's Lymphoma and Multiple Myeloma.

This is a double-arm, single-center study. This study is indicated for relapsed and/or refractory B-cell acute lymphoblastic leukemia, B-cell non-Hodgkin's lymphoma and multiple myeloma, the selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 120 patients will be enrolled for this trial. Primary objective is to explore the safety.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of CD19+ ALL, CD19+ NHL, or BCMA+ MM per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines (2020.v2);
2. Relapsed or refractory B cell hematological malignancies (meeting one of the following conditions):

   1. CR not achieved after standardized chemotherapy;
   2. CR achieved following the first induction, but CR duration is less than 12 months;
   3. Ineffectively after first or multiple remedial treatments;
   4. 2 or more relapses;
   5. Relapse after hematopoietic stem cell transplantation;
   6. Extramedullary leisions which were ineffective to radiotherapy or chemotherapy;
3. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;
4. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
5. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
6. Estimated survival time ≥ 12 weeks;
7. ECOG performance status 0 to 2;
8. Women of childbearing age had negative pregnancy test during screening period and before administration, and agreed to take effective contraceptive measures at least one year after infusion.
9. Patients volunteer to participate in the study and sign the informed consent.

Exclusion Criteria:

Subjects with any of the following exclusion criteria were not eligible for this trial:

1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
3. Pregnant (or lactating) women;
4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
5. Active infection of hepatitis B virus or hepatitis C virus;
6. Concurrent therapy with systemic steroids within 2 weeks prior toscreening, except for the patients recently or currently receiving in haledsteroids;
7. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
8. Creatinine \>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin \>2.0 mg/dl;
9. Other uncontrolled diseases that were not suitable for this trial;
10. Patients with HIV infection;
11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
SEED-LVPEI Myopia Study

This randomized clinical trial study aims to investigate the efficacy of novel SEED's EDOF based mid-lens design in controlling the myopia progression in

Indian children with these specific objectives:

1. To investigate the efficacy of SEED's 1-day pure extended depth of focus lenses controlling myopia progression in Indian children through a one-year randomized clinical study.
2. To investigate the role of SEED's 1-day pure extended depth of focus lenses in altering peripheral refraction of the eye to control myopia progression.
3. To determine if there is any specific cohort that shows better efficacy in myopia control with 1-day pure extended depth of focus lenses based on central and peripheral optics (degree of myopia and optical parameters).
4. To investigate the qualitative assessment of comfort and visual experience with the SEED's EDOF contact lenses through the questionnaire method.

This prospective randomized controlled clinical trial will be conducted in Myopia Research Lab, L V Prasad Eye Institute, Hyderabad and the study protocol will adhere to the tenets of the Declaration of Helsinki. Participants will be recruited through advertisements in local print media (newspaper), approaching schools, through clinical referrals. Children will be assigned to either the control group or intervention group randomly based on computer-generated random numbers operated by the investigator. All participants will undergo a cycloplegic refractive error assessment after the instillation of tropicamide 1% eye drops (or cyclopentolate 1% eye drops in case of varying refractive error between objective and subjective values). Axial length and cycloplegic refractive measurements will be taken with using Lenstar LS900 biometer and Shin- Nippon autorefractor respectively for scheduled follow up and will be compared with the baseline parameters.

Eligibility Criteria:
Inclusion Criteria:

* Myopia (SE) between -0.50D to -10.00D
* Astigmatism less than 0.75D
* Anisometropia less than 1.00D
* Age of the participant from 7 to 15 years
* Neophyte or existing soft contact lens wearer
* Best-corrected visual acuity (BCVA); ≤ 20/20
* Participants who are willing to wear the contact lens constantly

Exclusion Criteria:

* Participants who had any ocular or systemic conditions that could influence the refractive error
* Poor compliance of contact lenses from existing wearer
* Prior use of orthokeratology lenses/bifocal lenses/anti-myopia strategies
* Participants who had any medications that could influence the refractive error
Clinical Predictors of Extracorporal Shockwave Therapy Efficacy in Patients Presenting With Lateral Hip Pain

This pragmatic clinical trial is considering the variable response to treatment outcome of individuals with Greater Trochanteric Pain Syndrome (GTPS). The aim of this study is to identify predictors of focused extracorporeal shockwave therapy (fESWT) efficacy in individuals with GTPS. Specifically, the ability of clinically applicable measurements including: Patient demographics, co-morbidity, oestrogen levels, pain characteristics, hip abductor strength, time to pain during single-leg stance test, low back pain, and immediate pain reduction to local anaesthetic injection at the trochanter major insertion of Gluteus medius (GMed) during walking.


Eligibility Criteria:
Inclusion Criteria:

* Lateral hip pain, worst over the greater trochanter, present for a minimum of 3 months
* Age 35-70 years
* Female
* Pain at an average intensity of ≥3 out of 10 on most days of the last week.
* Tenderness on palpation of the greater trochanter
* Pain on one of the following:

Reproduction of pain on 30 sec single leg stand OR Positive Faber test

Exclusion Criteria:

* Any known advanced hip joint pathology where groin pain is the primary complaint and/or reproduction of groin pain with Faber or FADDIR.
* Where range of pure hip joint flexion is \<90°
* Radiating pain distal to the Gluteus Max + positive Straight Leg Raise (SLR-test \< 30°)
* Known advanced knee pathology or restricted range of knee motion (must have minimum 90° flexion and full extension)
* Any systemic diseases affecting the muscular or nervous system, and uncontrolled diabetes
* Malignant tumour OR Systemic inflammatory disease
* Any factors that would preclude the participant from having an MRI (e.g. pacemaker, metal implants, pregnancy, claustrophobia)
* If the participant is involved in a legal/workcover or other injury claim
* Fear of needles (trypanophobia)
* If the participant is unable to write, read or comprehend Danish
Effect of a L. Paracasei Strain on Grass Pollen Allergic Rhinitis Subjects

Various studies in animal and humans have shown a potential beneficial effect of probiotics consumption on allergy. However few studies exist that document their efficacy for upper airways allergies such as allergic rhinitis. The objective of this study is to investigate the effect of short-term oral administration of a L. paracasei or of a blend of 2 probiotics (L. acidophilus + B. lactis) on a nasal provocation test (NPT) with grass pollen, performed out of the pollen season. Adult volunteers with allergic rhinitis are enrolled in a randomized, double-blind study, based on two 4-weeks cross-over periods of product consumption separated by a washout period of 6-8 weeks. Objective and subjective clinical parameters of NPT as well as systemic and nasal immunological markers are compared before and after each treatment.


Eligibility Criteria:
Inclusion Criteria:

* age 18-40 years old
* history of allergic rhinitis during the latest grass pollen season confirmed by a positive skin prick test to grass pollen (wheal diameter \> 3mm) and a positive response to a NPT with grass pollen (combined nasal reaction threshold \<= 10000 standardized quality units/ml at the screening phase

Exclusion Criteria:

* any medical condition that could influence the study (pregnancy, viral or bacterial airway infection, active allergic rhinitis)
* uncontrolled asthma (peak expiratory flow \<20% of volunteer's best personal value)
* treatment with antihistamine or antibiotic treatment less than two weeks before enrolment or during the trial
Biomarkers in Pulmonary Arterial Hypertension Treated With Nilotinib

The investigators hypothesize that bone marrow progenitor cells are mobilized into the circulation in PAH, home to the lungs and differentiate into mast cells, which promote vascular remodeling and vasoconstriction through release of renin and chymase. As a corollary to this, the investigators hypothesize that anti cKit tyrosine kinase inhibitor (TKI), nilotinib, provides clinical benefit to patients through inhibition of mast cell progenitor proliferation, mobilization and differentiation. To test this, the investigators will determine if mast cell progenitors and mast cell biomarkers are related to nilotinib clinical response. This will be an ancillary study, part of a placebo-controlled, double-blind multi center clinical trial of nilotinib in pulmonary arterial hypertension.


Eligibility Criteria:
Inclusion Criteria:

This study is a substudy and subjects must be enrolled in the main trial:

See Study Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH) In clinical trials. (clinical Trial ID NCT01179737)

http://clinicaltrials.gov/ct2/show/NCT01179737?

Exclusion Criteria:

Subjects are not enrolled in the main study:

See Study Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH) In clinical trials. (clinical Trial ID NCT01179737)

http://clinicaltrials.gov/ct2/show/NCT01179737?term=tasigna+and+pulmonary+hypertension\&rank=1
Study of the Model to Predict 3-month Mortality Risk of Acute-on-chronic Hepatitis B Liver Failure

This study was to predict 3-month mortality risk of acute-on-chronic hepatitis B liver failure (ACHBLF) on an individual patient level using artificial neural network (ANN) system. The area under the curve of receiver operating characteristic (AUROC) were calculated for ANN and MELD-based scoring systems to evaluate the performances of the ANN prediction.

Hepatitis B virus (HBV) is a major human pathogen which causes high morbidity and mortality worldwide. HBV is one of the leading causes for rapid deterioration of liver function, which is a serious condition termed as "acute-on-chronic liver failure (ACLF)" with high mortality. There is a high prevalence of HBV in Asian developing countries where acute-on-chronic hepatitis B liver failure (ACHBLF) accounts for more than 70% of ACLF and almost 120, 000 patients died of ACHBLF each year. The transplantation of liver is the basic and strong effective therapeutic option for ACHBLF patients. However, liver transplantation is difficult to be extensively applied due to the shortage of liver donors and other socioeconomic problems. Thus, an early predictive model, which is objective, reasonable and accurate, is necessary for severity discrimination and organ allocation to decrease the mortality of ACHBLF.

MELD-based scoring systems still failed to predict the mortality of a considerable proportion of patients and their predictive accuracy was not satisfying enough.

The ANN is a novel computer model inspired by the working of human brain. It can build nonlinear statistical models to deal with the complex biological systems. In the recent years, ANN models have been introduced in clinical medicine for clinical validations, including predicting the hepatocellular carcinoma patients' disease-free survival and preoperative tumor grade, predicting the mortality of patients with end-stage liver disease and identifying the risk of prostate carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Acute hepatic insult manifesting as jaundice and coagulopathy
* Complicated within 4 weeks by ascites
* And/or encephalopathy in a patient with chronic HBV infection

Exclusion Criteria:

* Patients with evidence of non-B hepatitis virus
* alcohol abuse leads to liver failure
* autoimmune leads to liver failure
* oxic or other causes that might lead to liver failure
* past or current hepatocellular carcinoma
* liver transplantation
* serious diseases in other organ systems
The Western Ontario Rotator Cuff Index Arabic Version

To evaluate, translate, culturally adapt, validate, and investigate the reliability of Arabic version of The Western Ontario Rotator Cuff Index (WORC).

The null hypothesis of this study will be stated as:

Arabic language version of the WORC doesn't have face, content, or construct validity enough to measure quality of life related to rotator cuff disorders in Arabic patients.

Arabic language version of the WORC doesn't have reliability to measure quality of life related to rotator cuff disorders in Arabic patients

The WORC is an increasingly applied outcome measure for rotator cuff conditions. The WORC is a self-assessment scale that was developed to measure the quality of life of patients with RC disorders. It contains 21 items representing 5 subscales: physical symptoms 6 items, sports/recreation 4 items, work 4 items, lifestyle 4 items, and emotions 3 items, which encompass all aspects of heath as defined by the World Health Organization.

It has been translated and validated in several languages, including Chinese, Dutch, French-Canadian, Japanese, Norwegian, Persian, Polish, Portuguese - Brazilian, Spanish, Swedish and Turkish.

The current studies point out the increasing need for a questionnaire specifically developed to measure health related quality of life in patients treated conservatively, and respecting the following main characteristics: presenting adequate measurement properties and allowing to make comparisons of health-related quality of life between patients.

Cross-cultural adaptation allows globalization of information worldwide without the loss of the conceptual meaning. This enables the exchange and comparisons of valid information among different populations worldwide.

The Western Ontario Rotator Cuff Index has not been translated into the Arabic language, so it has a limited use in Egypt as well as Arabic countries. Therefore, the aim of this study is to translate, culturally adapt, validate, and investigate the reliability of Arabic version of The Western Ontario Rotator Cuff Index.

Eligibility Criteria:
Inclusion Criteria:

* Referred with rotator cuff tendinopathy or rotator cuff partial tear by physician.
* Able to read and write in Arabic.
* Their age will be Between 18 to 60 years old
* patients with chronic inflammatory diseases will be included

Exclusion Criteria:

* Patients with impairments in the cervical spine, elbow, or hand affecting the shoulder function
* Patients that have Cognitive alterations
* Patients that have any systemic disease that may affect patient's outcome.
Tacrolimus Versus Methotrexate as Rescue Therapy for Refractory Inflammatory Bowel Disease

Mesalazine, steroid, immunosuppressants and biologic agents are main medical treatments in treating inflammatory bowel diseases. Yet some patients develop severe side effects or initial invalid to conventional therapies. Some studies have already showed that tarcolimus and methotrexate are both effective in inducing and maintaining disease remission. Here we conduct a retrospective study to compare the efficancy of tarcolimus and methotrexate in treating refractory inflammatory bowel diseases as rescue therapy.


Eligibility Criteria:
Inclusion Criteria:

* Tarcolimus or methotrexate was used in refractory inflammatory bowel disease patents

Exclusion Criteria:

* Pregnant woman
A Post-marketing Surveillance to Assess Safety and Efficacy of Besivo

This study is a post-marketing surveillance of Besivo in participants with chronic hepatitis B.

This post-marketing surveillance required by Korea MFDS regulation. The objectives of this study are to monitor adverse events and effectiveness of Besivo.

Eligibility Criteria:
Inclusion Criteria:

* The patient diagnosed with chronic hepatitis B.
* The patient who is first prescribed and administered Besivo.

Exclusion Criteria:

* The patients who are overreacting to this drug or its components
* Medium to severe Renal function disorder
* The patient under 19
* The Patient who are taboo with L-Carnitine
Implementation of Brief Dynamic Interpersonal Therapy at the VA

The goal of the proposed project is to collect data from clinician files and the electronic medical record to describe the clinical implementation of Brief Dynamic Interpersonal Therapy (DIT), an individual psychotherapy for depression and anxiety, at the VA through psychology staff and trainees between 2012-present.

The goal of the proposed project is to collect data from clinician files and the electronic medical record to describe the clinical implementation of Brief Dynamic Interpersonal Therapy (DIT), an individual psychotherapy for depression and anxiety, at the VA through psychology staff and trainees between 2012-present. The study will collect data on patient characteristics (e.g. demographics, diagnoses, reasons for referral, etc.), attendance, and treatment outcome of depression, anxiety and psychosocial functioning to evaluate and describe the feasibility of implementing DIT at the VA.

Medical records of veterans who were provided with DIT treatment between 2012-present will be reviewed and data on patient characteristics (which will include demographic information, diagnoses, reasons for referral, etc.), treatment compliance, and treatment outcome as measured by changes in depression, anxiety, and psychosocial functioning during the treatment period and up to the present will be collected. The investigators estimate that approximately 100 Veterans have been offered and/or provided DIT since 2012 by psychology trainees and staff. This study will provide preliminary data on the feasibility of implementing DIT treatment at the VA. The first trial of DIT for MDD in the VHA is currently being conducted by the PI and the information from the retrospective chart review would help to provide additional data as part of a proposal for a larger scale RCT of DIT.

Eligibility Criteria:
Inclusion Criteria:

- receive DIT treatment at VANYHHS between 2012-present

Exclusion Criteria:

- was not referred for, or did not receive at least 1 DIT session at VANYHHS between 2012-present
Avoid FFS - Use of the Atrial Pacemaker Lead 1699 With Very Short Tip Ring Spacing to Avoid Far Field Sensing

The purpose of this study is to evaluate the possibility to program the shortest possible Post Ventricular Atrial Blanking Period (PVAB) and high sensitivity without getting inappropriate Mode Switch due to Far Field R-Wave sensing when using the new Tendril 1699T lead. Comparison with Tendril 1688T or 1388T with optimized Post Ventricular Atrial Blanking (PVAB).

Far-field R-wave sensing (FFS) in the atrial channel of dual chamber pacemakers is a relevant source for inappropriate Mode Switch from the DDD mode to the DDI or VDI mode. Inappropriate loss of atrioventricular synchrony due to false positive Mode Switch is hemodynamically disadvantageous, may induce atrial tachyarrhythmias, can lead to pacemaker syndrome, and impairs the reliability of pacemaker Holter data. The aim of the study is to determine whether the use of a new atrial screw in lead with ultra short tip-ring distance of 1.1 mm (Study Group) eliminates the need for individual adjustment of the postventricular atrial blanking period (PVAB) based on an additional test in the Control Group with standard leads.

Eligibility Criteria:
Inclusion Criteria:

* Indication for dual chamber pacing
* Implantation of an Identity (ADX) DR or Victory or later pacemaker (St. Jude Medical)
* Bipolar atrial pacing electrode
* Age \>= 18 years

Exclusion Criteria:

* Persistent / permanent Atrial Arrhythmia
* Pacemaker Revision
* Pregnancy
* Participation in another Study involving active implantable medical devices
* Unable to complete follow up
* Missing patient informed consent
* Cardiac surgery or myocardial infarction within the last 4 weeks
* Planned cardiac surgery within 3 months after enrollment