cyrilzakka/clinical-trials huggingface dataset:
A Study Evaluating the Efficacy and Safety on Moderate to Severe Dry Eye

The purpose of this study is to compare the efficacy and safety of HBM9036 Ophthalmic Solution versus placebo in the treatment of dry eye

HBM9036 is a molecularly engineered tumor necrosis factor receptor 1 (TNFR1) fragment.

A total of 100 subjects are expected to be randomized. Subjects will be randomized 1:1 at Visit 2 to HBM9036 Ophthalmic Solution or placebo group, bilaterally BID for eight weeks. The primary efficacy endpoint is sign changes from baseline in change from pre- to post-CAE inferior corneal staining score (ICSS) of the study eye evaluated at week 8 .

Eligibility Criteria:
Inclusion Criteria

1. Have a history of use eye drops for dry eye symptoms within 6 months of Visit 1 or desire to use eye drops;
2. Have in the study eye a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2;
3. Be willing and can adjust current treatment for dry eye according to the protocol, judged by the Investigator;
4. Must be willing to complete all study assessments required by the protocol.

Exclusion Criteria:

1. Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
2. Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months, or had femtosecond small incision lenticule extraction (SMILE) within the last 12 months, or had phacoemulsification within the last 3 months, or had dry eye or aggravation of dry eye caused by other ocular operations has not been stable;
3. Have used ophthalmic cyclosporine A, tacrolimus or Xiidra® within 60 days prior to Visit 1;
Image Guided EVD Placement

To determine if use of the Stryker Nav3 image guidance system offers superior results in external ventricular drain (EVD) placement compared to the standard free-hand technique.

An external ventricular drain (EVD) is a small tube that is placed into a space in the brain called a ventricle. This is done to drain fluid in the brain that sometimes builds up as a result of surgery or a traumatic brain injury/accident. This is one of most commonly performed procedures in Neurosurgery and is done bedside, not in the operating room. Typically, surgeons will use the "free-hand" technique to place these drains which involves relying on a CT scan, which shows the structures inside of the brain, and their knowledge of the anatomy of the brain and where the EVD should be placed. Image-guidance systems exist which create real time imaging of the patients brain and can act like a GPS to help guide the placement of the EVD in the correct spot. This trial is planned to determine if using the image guidance system does offer improved accuracy in EVD placement, lowering the number of attempts required and therefore the amount of time spent placing the EVD and risk of complications and infections. A pilot study will be done first, using a convenience sample at the Hamilton General Hospital to determine the feasibility of running a larger scale trial in the future.

Eligibility Criteria:
Inclusion Criteria:

* patients requiring EVD placement
* patients who can safely and reasonably be randomized to either study arm
* patients with available pre-procedural head CT
* written/verbal consent obtained

Exclusion Criteria:

* patients with very small ventricles/distorted ventricular anatomy from traumatic brain injury (ie it is not reasonable to randomize the patient)
* scenarios where the EVD must be inserted immediately and there is not time to obtain consent
* scenarios where bedside image guidance system (NAV3) is unavailable
* subjects medically or neurologically unstable to obtain pre-EVD CT scan
* EVD revisions on ipsilateral side during same admission
A Prospective, Interventional Study Assessing Response to Cytarabine, Daunorubicin and Etoposide (ADE) for First Relapse of Paediatric Acute Myeloid Leukemia

One-third to one-half of patients with AML relapse and in general relapsed AML patients have a poor prognosis. The treatment of relapsed AML consists of induction chemotherapy followed by Allogenic Stem Cell Transplant (ASCT). However, at present there is no standard salvage chemotherapy regimen for relapsed AML, as no study has shown any one regimen to be significantly superior. Anthracyclines, Fludarabine, Etoposide and cytarabineare active agents in AMLand have been used as monotherapy and in combination in refractory and relapsed AML patients. According to previous studies the present CR rate of different regimens ranges from 50-70%. A retrospective analysis (unpublished) conducted at IRCH, AIIMS on relapsed AML patients treated with ADE (Cytarabine, Daunorubicin and Etoposide) chemotherapy showed the CR rates of approximately 70%. Therefore, we have planned this study to test the efficacy and toxicity of ADE induction chemotherapy in relapsed AML patients in a prospective manner.


Eligibility Criteria:
Inclusion Criteria:

1. Either gender with age ≤18 years at initial diagnosis
2. AML(non-M3) patients at first relapse (medullary)

Exclusion Criteria:

1. Primary refractory AML \&secondary AML
2. More than or equal to 2 relapses of AML
3. Symptomatic cardiac dysfunction (CTCAE Grade 3 or 4)
4. Active infection(pneumonia etc.)
5. Any other organ dysfunction (CTCAE Grade 4)
6. Patients not willing to consent for the study
Translational Research GRICS-CineCardiac

This project is a pilot study which aims at showing the feasibility of free breathing cardiac MRI using GRICS (Generalized Reconstruction by Inversion of Coupled System)software in a clinical environment.

The GRICS technique has been developed by the IADI (Diagnostic, Adaptive and Interventional Imaging)lab, Nancy, France. It enables free breathing MRI thanks to a reconstruction algorithm which provides artefact-free images based on raw MR data and physiological data from external sensors (respiratory belts, ECG.

In this study, we want to acquire free breathing cardiac cine images during a standard cardiac MR exam and compare those data with the breath-hold ones.


Eligibility Criteria:
Inclusion Criteria:

* candidate to cardiac MR exam because of ischemic or dilated cardiopathy
* legally an adult
* having heath insurance
* having signed the consent form

Exclusion Criteria:

* dyspnea
* atrial fibrillation
* pain while lying on the back for a long time
* inability to follow a procedure
* contraindication to MRI
* contraindication to gadolinium chelate injection
Effectiveness and Safety of Pharmacopunture Therapy for Chronic Low Back Pain: A Pragmatic Randomized Controlled Trial

This is a multi-center, 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for chronic low back pain.

This is a multi-center, 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for chronic low back pain. Participants who voluntarily signed informed consent form and eligible for the study were randomly assigned in a 1:1 ratio (50:50) for pharmacopuncture therapy group and physical therapy group. Participants of each group will receive total 5 weeks of intervention. This is a pragmatic randomized controlled trial, so physicians will have medical decision making according to each participant's conditions and choose the specific type and volume of pharmacopuncture and physical therapy.

Eligibility Criteria:
Inclusion Criteria:

1. low back pain for more than 6 months
2. Numeric rating scale (NRS) score for low back pain 5 or more
3. 19-70 years old
4. participants who agreed and signed informed consent form

Exclusion Criteria:

1. Spine metastasis of cancer, acute fracture of spine, or spine dislocation
2. Progressive neurologic deficits or severe neurologic deficits
3. Soft tissue diseases that can induce low back pain (ie. cancer, fibromyalgia, rheumatoid arthritis, gout, etc)
4. Presence of chronic underlying disease which can interfere the efficacy or interpretation (ie. stroke, myocardial infarct, kidney disease, dementia, diabetic neuropathy, epilepsy, etc)
5. Concurrent use of steroids, immunosuppressants, or psychotropic medications
6. Hemorrhagic disease, severe diabetes or taking anticoagulant drug
7. Participants who took NSAIDs or pharmacopuncture within 1 week
8. Pregnant or lactating women
9. Participants who had undergone lumbar surgery within 3 months
10. Participants who had participated in other clinical trial within 1 month, or have plan for participation in other trial during follow up period of this trial
11. Participants who can not write informed consent
12. Participants who is difficult to participate in the trial according to investigator's decision
The Effect of Mid-urethral Sling on the Urethral Dynamic Shape and Motion

The purpose of this prospective cohort study is to investigate the effect of sling on urethral dynamic shape and motion using static and dynamic pelvic floor ultrasound and additionally compare the findings among women with successful vs failed surgical outcome.

This study is designed as a prospective cohort study. Our hypothesis is that mid-urethral sling provides backstop for excessive "swing motion" of distal urethra and helps with urethral compression along its luminal axis.

Aim 1: Investigate the effect of mid-urethral sling on the urethral shape at rest and maximum Valsalva, in other words dynamic urethral shape.

Aim 2: Compare the effect of mid-urethral sling on urethral dynamic shape in women with successful surgical outcome (absence of stress urinary incontinence at 3 and 12 months after the surgery) and women with surgical failure (presence of stress urinary incontinence at 3 and 12 months after the surgery).

Eligibility Criteria:
Inclusion Criteria:

* stress urinary incontinence interested in treatment with mid-urethral sling
* able to consent in english and come to post-operative and research visits

Exclusion Criteria:

* contraindication to mid-urethral sling
* detrusor overactivity \> 40cm H2O
* post-void residual \> 150mL
* Maximum urethral closure pressure \< 40 cm H2O
Epidemiological Analysis for Hereditary Angioedema Disease

An international, multicenter, epidemiological, observational study investigating the prevalence of Hereditary Angioedema (HAE) disease among participants with recurrent episodes of abdominal pain of no obvious etiology.

Hereditary Angioedema (HAE) is a rare autosomal dominant disorder characterized most commonly by deficient (type 1) or nonfunctional (type 2) C1 inhibitor protein (encoded by SERPING1 gene). The disorder is associated with episodes of angioedema of the face, larynx, lips, abdomen, and extremities. The angioedema is caused by the activation of the kallikrein-kinin system that leads to the release of vasoactive peptides, followed by edema, which in severe cases can be life threatening.

Gastrointestinal involvement occurs in 93% of patients with HAE and may be the only manifestation of the disease. However, individuals with gastrointestinal symptoms are rarely considered for HAE and the disease can be misdiagnosed for several years.

EHA study focuses on the gastrointestinal complications of HAE as a potential area of misdiagnosis leading to surgical morbidity. Aim of the study is to investigate the prevalence of HAE among participants experiencing recurrent abdominal pain attacks with no clear etiology. The HAE-positive samples in the study will be further analyzed biochemically to identify disease-specific biomarker that may support the development of new diagnostic tools for HAE disease.

Eligibility Criteria:
INCLUSION CRITERIA

* Informed consent will be obtained from the participant or the parent or legal guardian
* Participants with previous episodes of abdominal pain of no obvious etiology
* Participants aged between 2 to 60 years old

EXCLUSION CRITERIA

* Previous diagnosis of HAE
* Inability to provide informed consent
* The etiology of abdominal pain attacks is determined
* Participants that are younger than 2 years old or older than 60 years old
* Previous enrolled in the study
Effects Of Propofol-Dexmedetomıdıne And Propofol- Remıfentanıl In Hysteroscopıc Operations.

In our study, the investigators aimed to compare the effects of dexmedetomidine-propofol and remifentanil-propofol combinations on perioperative spontaneous respiration, hemodynamics, recovery, participants, surgeon and anesthetist satisfaction in hysteroscopy, which is one of the ambulatory surgery.

This study was conducted prospectively after the approval of Van Yüzüncü Yıl University Ethics Committee. A total of 80 participants in 2 groups of 40 ASA I-II, aged 18-65 years were included in the study. On the day of the operation, vascular access was established with a 20 G branule in all patients before the procedure. The participants who were taken to the gynecology table were routinely monitored in the supine position as required by the procedure.

All participants were premedicated with 0.025 mg/kg Midazolam (Demizolam®, Dem, Turkey) after starting oxygen at 2 lt/min with a nasal cannula. The participants were randomly divided into two groups as Group DP and RP. Propofol (Propofol-®Lipuro 1%(10 mg/ml), B. Braun Indonesia ) 1mg/kg bolus was administered to both groups. Dexmedetomidine (Sedadomide 200 µg/2 ml, KOÇAK FARMA Turkey)

1mcg/kg bolus was administered to Group DP in 10 minutes, then 0.2-1.4 mcg/kg/hour infusion dose was started. After a 0.25mcg/kg bolus of Remifentanil (Ultiva®, GlaxoSmithKline, Belgium) was administered to Group RP, a 0.025-0.1mcg/kg/minute infusion dose was started.Hemodynamic data and respiratory parameters of the groups before and after sedation were recorded. The depth of anesthesia was recorded using the Ramsey sedation scale, and the recovery scores were recorded with the Modified Aldrete score. The facial pain scale was used to evaluate pain. Depth of anesthesia was provided so that the Ramsey Sedation Scale of the patients was greater than four. Patients with RSS\&lt;4 were excluded from the study by administering additional propofol.

Eligibility Criteria:
Inclusion Criteria:

AGE 18-65 ASA I AND II

Exclusion Criteria:

* OTHERS
Constructing A Model of Health Promotion and Active Aging for Community-Dwelling Older Adults

Cognitive intervention for people with subjective cognitive complaints can be categorized into cognitive training, cognitive rehabilitation, psychoeducation, lifestyle intervention, etc. Literature have suggested multicomponent cognitive interventions can have better outcomes. However, studies to support this proposition are still limited. Few studies have also examined the influences of cognitive intervention on functional performance. This study was to examine the effectiveness of a multicomponent cognitive intervention for community-dwelling elderly with subjective cognitive complaints.


Eligibility Criteria:
Inclusion Criteria:

1. Subjective cognition complaint by the client or caregiver: In our study, participants reported more than one complaint in Everyday Memory Questionnaire and Cognitive Function Questionnaire will be included.
2. Objective cognition deficits: participants with scores under 1.5 Standard Deviation in Trail making test, Contextual memory test and Rivermead Behavior Memory Test-3rd edition were included.
3. Preserved most daily living function: participants have reported no Activity of Daily Living (ADL) difficulties.

Exclusion Criteria:

1. A confirmed diagnosis of dementia
2. With visual and auditory impairments, and other neurocognitive disease that can potential influence participation in group activities, including stroke, Parkinson's disease and traumatic brain injury, major depression, and substance abuse.
3. With Mini Mental Status Exam \<=24 (education status beyond primary school); or \<=16 (No education)
4. With less than 10-session participation rate out of 12.
Arginase Inhibition in Humans With Obesity

To evaluate the efficacy of arginase inhibition on endothelial function in humans with obesity.

The study is performed on one group of subjects with body mass index \>35 and the absence of type 2 diabetes.

Inclusion criteria:

Body mass index \>35 kg/m2.

Exclusion criteria:

Age \>80 years. Type 2 diabetes defined as \>7 mmol/L in fasting plasma glucose or \>11 mmol/L following 2h of oral glycemic load.

Myocardial infarction/unstable angina within 6 weeks prior to the study. Treatment with oral anticoagulants (Warfarin or New oral anticoagulants), Raynaud's phenomenon, peripheral vasculopathies, arterial shunting or other vascular surgery of the study arm.

Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol.

Participant in an ongoing study. Unwillingness to participate following oral and written information.

Forearm blood flow is determined by venous occlusion plethysmography. Endothelium-dependent vasodilatation is determined during intra-brachial artery infusion of serotonin (21, 70 and 210 ng/min). Endothelium-independent vasodilatation is determined by infusion of sodium nitroprusside (SNP; 1, 3 and 10 µg/min). Each dose is given for 2 min at a rate of 2.5 ml/min. Data are expressed as percentage change in forearm blood from baseline flow.

Fifteen subjects are included. On the day of the study the subject arrives to the laboratory after having a light breakfast. Forearm vessels of the non-dominant arm are cannulated and forearm blood flow is determined as described above. Baseline endothelium-dependent and endothelium-independent vasodilatation is determined by intra-arterial infusions of serotonin and SNP, respectively. Thereafter an intra-arterial infusion of the arginase inhibitor N-omega-hydroxy-nor-l-arginine (nor-NOHA) is administered as an intra-arterial infusion at a rate of 0.1 mg/min and is maintained for 120 min. The dose is based on a previous study by our group demonstrating improved endothelial function. Endothelium-dependent and -independent vasodilatation is reassessed at 120 min of infusion.

Eligibility Criteria:
Inclusion Criteria:

BMI \>35kg/m2

Exclusion Criteria:

Age \>80 years. Type 2 diabetes defined as \>7 mmol/L in fasting plasma glucose or \>11 mmol/L following 2h of oral glycemic load.

Myocardial infarction/unstable angina within 6 weeks prior to the study. Treatment with oral anticoagulants (Warfarin or New oral anticoagulants), Raynaud's phenomenon, peripheral vasculopathies, arterial shunting or other vascular surgery of the study arm.

Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol.

Participant in an ongoing study. Unwillingness to participate following oral and written information.
Gastroesophageal Reflux Disease Diagnostic Trial

Gastroesophageal reflux disease (GERD) is a very common condition in clinical practice. In China, GERD affects nearly 150 million patients, whose quality of life are seriously impacted. Currently, the diagnosis of GERD primarily depends on the results of 24h reflux monitoring. However, such examination is under a quite low acceptability. As a result, a large number of patients were not diagnosed timely and accurately, and serious social problems are induced, such as drug abuse of proton pump inhibitor. Our team has previously developed a novel device for esophageal cell enrichment and established an internationally pioneering method of cytological screening for esophageal cancer based on cutting-edge deep learning technology. This project aims to develop multiple deep learning algorithms and establish an innovative method for diagnosis of GRED, using the novel esophageal cell enrichment technology. The research includes: 1) constructing deep learning algorithms for automatic esophageal inflammatory cells recognition and classification; 2) mining and extracting the key features of esophageal squamous cells and inflammatory cells under physician-AI interaction; 3) establishing a prediction model for GERD by integrating digital features of squamous cells and inflammatory cells and building a cloud-based automatic diagnosis system; 4) investigating the immuno-infiltration atlas of GERD and its diagnostic value based on the enriched inflammatory cells. The ultimate goal is to solve current clinical problems and realize rapid, convenient, and accurate diagnosis of GERD.


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years and ≤85 years, male or female;
2. A visit was made for symptoms such as persistent reflux, heartburn, bloating, early satiety, and belching;
3. Patients volunteered to participate in the clinical trial, signed an informed consent form, and were able to cooperate with clinical follow-up.

Exclusion Criteria:

1. History of esophageal surgery;
2. Presence of dysphagia, esophagogastric fundal varices, or esophageal stenosis;
3. Presence of coagulation disorders or taking anticoagulant or antiplatelet drugs;
4. Those with a life expectancy of less than 5 years;
5. Persons with mental anomalies who are incapable of behavioral autonomy;
6. Other conditions that, in the judgment of the physician, preclude participation in the trial.
Resistive Action Video Games Enhance Functional Fitness of Disabled Workers in Sheltered Workshops

Aims: Investigating the efficacy of resistive action video games on functional fitness (FF) of disabled workers in sheltered workshops (DWSWs).

Methods: Thirty-two DWSWs participated in this study and were allocated as either experimental group (EG) or control group (CG). DWSWs in EG underwent three 60-minute sessions each week for 12 weeks; those in CG maintained daily routine. The outcomes included all components FF and were measures at pre-, mid- and post-training.

Purpose: To investigate the efficacy of a training program including resistive action video games on functional fitness (FF) of disabled workers in sheltered workshops (DWSWs).

Material and methods: Thirty-two DWSWs participated in this study and were allocated as either experimental group (EG) or control group (CG). DWSWs in EG underwent three 60-minute training sessions each week for 12 weeks. One of the session is group training and two of the sessions are individual session. In group session, the participants do aerobic exercise following a video which was launch by the health management ministry of city government. In the individual session, the participants play play two video games alternatively. The video games used are Fitness Boxing 2 and Adventure Ring-Fit. In addition to the training program, the participants in the EG maintain work and leisure routine in addition to the added training. The participants in the CG maintained daily work and leisure routine.The outcome measures included body mass index, body weight, body fat percentage, skeletal muscle rate, muscle strength, cardiopulmonary endurance, flexibility, balance and agility. All participants must be evaluated of the outcome measures at pre-, mid- and post-training time point.

Eligibility Criteria:
Inclusion Criteria:

* (1) aged more than 20 years; (2) diagnosis of an intellectual disability, autism, or a psychiatric disorder; (3) employed for at least 6 hours per day and five days a week in the sheltered workshop; (4) capable of following verbal instructions to enable outcome measurement and of participating in the training program; and (5) voluntary agreement to participate and signed the informed consent form

Exclusion Criteria:

* (1) advisement against performing moderate- to high-intensity physical activities by a physician and (2) physical limitations preventing independent walking or standing without an assistive device.
The Genotype and Phenotype of Lymphangioleiomyomatosis

This study aims to differentiate between sporadic Lymphangioleiomyomatosis and Tuberous Sclerosis Complex-associated Lymphangioleiomyomatosis.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 y/o
* Patient with Chest CT showed cystic lung disease, suspected Lymphangioleiomyomatosis

Exclusion Criteria:

* age \< 18 y/o