cyrilzakka/clinical-trials huggingface dataset:
Dilated Versus Non-Dilated Wavefront Corrections for Patients With Down Syndrome

Individuals with Down syndrome (DS) live with visual deficits due, in part, to elevated levels of higher-order optical aberrations (HOA). HOAs are distortions/abnormalities in the structure of the refractive components of the eye (i.e. the cornea and the lens) that, if present, can result in poor quality focus on the retina, thus negatively impacting vision. HOAs in the general population are overall low, and thus not ordinarily considered during the eye examination and determination of refractive correction. However, for some populations, such as individuals with DS, HOAs are elevated, and thus the commonly used clinical techniques to determine refractive corrections may fall short. The most common clinical technique for refractive correction determination is subjective refraction whereby a clinician asks the patient to compare different lens options and select the lens that provides the best visual outcome. Given the cognitive demands of the standard subjective refraction technique, clinicians rely on objective clinical techniques to prescribe optical corrections for individuals with DS. This is problematic, because it may result in errors for eyes with elevated HOA given that these techniques do not include measurement of the HOAs. The proposed research evaluates the use of objective wavefront measurements that quantify the HOAs of the eye as a basis for refractive correction determination for patients with DS. The specific aim is to determine whether dilation of the eyes is needed prior to objective wavefront measurements. Dilation of the eyes increases the ability to measure the optical quality of the eye and paralyzes accommodation (the natural focusing mechanism of the eye), which could be beneficial in determining refractions. However, the use of dilation lengthens the process for determining prescriptions and may be less desirable for patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Down syndrome
* Able to be dilated
* Able to fixate for study measures
* Able to respond for visual acuity testing

Exclusion Criteria:

* Ocular nystagmus
* History of ocular or refractive surgery (strabismus surgery is okay)
* Corneal or lenticular opacities
* Ocular disease
Exercise Intervention to Improve Quality of Life in Patients With Colorectal Cancer

The purpose of this study was to explore the 12-week effectiveness of home exercise intervention for colorectal cancer patients in improving fatigue, sleep, muscle endurance, and quality of life.

A. Explore the effect of "12-week home exercise intervention" in improving the fatigue of colorectal cancer patients.

B. Explore the effect of "12-week home exercise intervention" in improving the sleep quality of patients with colorectal cancer.

C. Explore the effect of "12-week home exercise intervention" in improving the muscle endurance of patients with colorectal cancer.

D. Explore the effect of "12-week home exercise intervention" in improving the quality of life of colorectal cancer patients.

The study was conducted at the colon and rectal outpatient departments. A randomized controlled trial design was adopted. The participants were divided into an interventional group and a conventional therapy control group based on block randomization in a 1:1 ratio. Data were collected when patients returned to the clinic.

Eligibility Criteria:
A. Inclusion criteria

1. Above the age of 20, with colorectal cancer pathological stage in situ, I, II, and III.
2. Coherent, with no mental abnormalities.
3. Able to read Mandarin or communicate in Mandarin and Taiwanese to complete the questionnaire.
4. Provided informed consent.
5. No physical disabilities.

B. Exclusion criteria

1. Acute inflammation of the limbs and joints.
2. Previous abdominal surgery within 3 months.
3. Symptomatic cardiovascular events.
4. Long-term anti-depressant drug use.
5. Unilateral restrictions of the upper or lower limbs.
6. History of medium- or high-intensity exercise for more than half a year.
7. Having colostoma or ileostoma.
The Use of the Internet to Facilitate Weight Loss and Maintenance.

This project is assessing the effectiveness of using the Internet as a tool to facilitate the maintenance of weight lost in a behavioral weight control program. Participants attend a standard behavioral weight control intervention via Interactive Television and after 6 months are randomly assigned to one of three groups; a control group, an in-person weight maintenance group and a maintenance group that meets over the Internet. This research project is being conducted in Vermont.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 25 and 39.9
* Internet connection

Exclusion Criteria:

* Major medical problems
* Inability to walk for exercise
Efficacy of TCA Effect on Varicella Atrophic Scars

This study aims to determine the efficacy of 70% trichloroacetic acid on atrophic scars of varicella

high concentration trichloroacetic acid peeling has been shown to be effective in treating and flattening the atrophic acne scars. According to the lack of an effective and low cost therapy for removing these relative common and nuisance lesions; We aimed to answer that whether we could achieve the same results from 70% TCA on atrophic varicella scars.

Eligibility Criteria:
Inclusion Criteria:

* Atrophic varicella scar on face

Exclusion Criteria:

* Active varicella infection
* Active Herpetic infection
* Previous history of keloid formation
Community-Based Engagement to Improve Lung Cancer Screening and Outcomes

The goal of this pilot study is to understand the impact of a mobile lung cancer screening clinics in individuals from neighborhoods and communities with less access to resources in Boston, Massachusetts who are at high risk for lung cancer. The main questions it aims to answer includes:

* Is mobile lung cancer screening is feasible and acceptable?
* Is collecting social needs data during the mobile lung cancer screening clinics feasible?

Participants will:

* Complete an intake survey, providing information about their demographic, medical, and social needs information.
* Undergo a shared decision-making conversation to determine whether lung cancer screening should be done.
* Undergo lung cancer screening.
* Undergo a debriefing conversation and fill out an acceptability survey.
* Undergo a semi-structured phone interview between four and eight weeks after lung cancer screening date.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and the willingness to sign a written informed consent document prior to any study-related procedures.
* Willing to undergo treatment.
* Adults between the ages of 50 and 80 years.
* No recent CT or MRI imaging within the last year.
* Currently smokes tobacco or has quit smoking tobacco within the past 15 years.
* Has a tobacco smoking history of at least 20 pack years (i.e. one pack per day for the last 20 years or equivalent).
* Has never been diagnosed with lung cancer.

Exclusion Criteria:

* Adults/children less than 50 years, or greater than 80 years of age.
* Has never smoked tobacco.
* Has smoked tobacco but quit more than 15 years ago.
* Has a tobacco smoking history of less than 20 pack years.
* Presence of major comorbidity(ies) that could prevent treatment.
* Previous diagnosis of lung cancer.
* In the opinion of the investigator, the subject is not an appropriate candidate for the study.
Effects of Pain Neuroscience Education and Standard Rehabilitation Regime in Patients of Carpal Tunnel Syndrome

The aim of this study is to check the effects of Pain Neuroscience education and standard rehabilitation regime in patients of carpal tunnel syndrome.

In 2017 a stud assessed effectiveness of standard conservative protocol of CTS and nerve mobilization along with and without PNE and documented that standard conservative care seems to be the most appropriate option for pain relief, although neuroscience education might be a complementary option to accelerate recovery of function. More high-quality research is still necessary to determine its effectiveness and the subgroups of patients who may respond better to this treatment.

In 2019 a study was done to assess the effect of PNE and standard rehabilitation exercises on the 41 patients of CTS. The experimenting group was given one session of PNE plus exercises and the control group was given exercise therapy only. Patients were randomly allocated and double blinded. The analysis of study showed better results with experimental group rather than control group.

Many studies have found the effects of standard rehabilitation of Carpal Tunnel syndrome and their results in controlling pain and dysfunction. However as per researchers' knowledge little literature is available on effects of pain neuroscience education and standard rehabilitation regime in carpal tunnel syndrome. Therefore, this study6 is going to determine the effects of effectiveness of Pain Neuroscience education and standard rehabilitation regime in patients of carpal tunnel syndrome.

Eligibility Criteria:
Inclusion Criteria:

* age between 20_40 years old.
* Medical diagnosis of moderate to severe CTS.
* Symptoms of CTS since 1month
* Unilateral or bilateral symptoms
* Availability and access to the hospital.

Exclusion Criteria:

* Inability to understand instructions, neurological conditions of the central nervous system (e.g. stroke, spinal cord injury)
* Patients on treatment with alternative therapies
* Previous participation in a research program
* Previous surgery on the affected upper limb
A Study of Dulaglutide in Healthy Participants

The purpose of this study is to evaluate a new formulation of dulaglutide (study drug) administered under the skin as one injection using a single dose pen compared to three injections using a pre filled syringe.

This study will evaluate how much of the study drug enters the body and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.

The study will last about 84 days, including screening and will require overnight stays in the clinical research unit (CRU).


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy as determined by medical history and physical examination at time of screening
* Have a body mass index of greater than or equal to (≥) 23 kilograms per meter squared (kg/m²) inclusive

Exclusion Criteria:

* Have known allergies to dulaglutide, glucagon-like peptide-1 (GLP-1) related compounds, or any components of the formulation
* Have family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC
* Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis) or gastrointestinal disorder (e.g., relevant esophageal reflux or gall bladder disease) or any gastrointestinal disease which impacts gastric emptying (e.g., gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by GLP-1 analogs
Efficacy and Safety Evaluation in Recurrent Wheezing Attacks

The study will be conducted in two hospitals of the same geographic area. It will be included children \<3-years-old with recurrent wheezing attacks, confirmed by the review of the medical records, in the previous 12 months or a shorter time for those younger than one year.

This randomized, double-blind, placebo-controlled, parallel-group study will included 120 children \<3 years old with ≥3 episodes of wheezing during the previous year. They will receive active treatment or placebo for six months. The main outcome will be the number of wheezing attacks during one year. Other outcomes were duration and severity of wheezing attacks , symptom and medication scores, and use of health resources.

Eligibility Criteria:
Inclusion Criteria:

* Subjects whose parents /legal representative have given written informed consent.
* Both gender
* Subject up to 36 months of age.
* Subjects with recurrent bronchospasms (wheezing attacks); 3 or more exacerbations in the last 12 months

Exclusion Criteria:

* Subjects whose parents/legal representative have not given written informed consent.
* Subjects out of aged range
* Subjects with malignancies or chemotherapy treatment
* Subjects included in another clinical trial in the last 12 months.
* Subject in immunosuppressive or immunostimulatory treatment
* Subjects who have received iv gamma globulin in the past 12 months.
* Subjects diagnosed with candidiasis or fungal recurrent infections.
* Subjects diagnosed with malabsorption syndrome
* Subjects with clinical allergy to common aeroallergens in the geographical area.
* Subjects with hepatitis virus infections, HIV and tuberculosis
Efficacy and Safety of Cipros 10 Association on the Isolated Hypertriglyceridemia and Dyslipidemia Treatment

The purpose of this study is to evaluate the efficacy of Cipros 10 association in the treatment of Dyslipidemia Treatment


Eligibility Criteria:
Inclusion Criteria:

* Participants of both sexes, aged 18 years or more;
* Participants with the diagnosis of Dyslipidemia presentinf low or intermediate cardiovascular risk, according to the Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
* Signed consent.

Exclusion Criteria:

* Diagnosis of familial hypercholesterolemia and other genetic diseases;
* Using medications that may interfere with the metabolism or serum levels of triglycerides;
* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* Presence of concomitant cardiovascular disease, renal failure and hepatic Failure;
* Decompensated diabetes;
* Current smoking;
* History hypersensitivity to the active ingredients used in the study;
* Pregnancy or risk of pregnancy and lactating patients;
* History of alcohol abuse or illicit drug use;
* Participation in clinical trial in the year prior to this study.
Effects of Exercise Intervention and Rehabilitation Exercise Intervention in Patients With Type 2 Diabetes

The purposes of the study are

* to determine if a supervised exercise intervention is improving the metabolic parameters in type 2 diabetes patients
* to investigate what kind of intervention (strength endurance training versus combined strength endurance training and rehabilitation exercise intervention)is more effective in improving the metabolic parameters in patients with type 2 diabetes
* to assess which exercise intervention induces higher effects to the metabolic rate and cardiac and pulmonary capacity
* to investigate what kind of intervention includes highest effects in long term persistence of these positive effects


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of type 2 diabetes (ADA criteria)
* admitted diabetes treatment will be diet and oral hypoglycemic agents

Exclusion Criteria:

* sports intervention \> 60 minutes per week

medical conditions

* proliferative retinopathy
* instable coronary heart disease
* acute clinically significant intercurrent disease
* inability to perform scheduled physical activity programs
Comparison of the Ultrasound Supra-inguinal Fascia Iliaca Block vs Femoral Nerve Block

Patients were randomly assigned to tow groups: infrainguinal ultrasound guided iliaca fascia block (FIBSI) and femoral nerve block (FNB) for FIBSI, the probe is placed transversely between anterior superior iliac spine (ASIS) and the pubic spine. The transducer is translated laterally to identify the Sartorius muscle. Cephalic inclination of the probe. The medial end of the transducer faces towards the umbilicus, which is the final position. The 100mm neurostimulation needle is advanced in the In Plan approach to pass through the iliac fascia. Once the correct position is confirmed, 30 ml of 1% Ropivacaine is gradually injected between the iliac fascia and the iliac muscle.

For FNB, the probe was placed under the inguinal ligament. The femoral vessels and the nerve section are visualized; The 100mm neurostimulation needle is advanced in the In Plan approach and 30ml of 1% Ropivacaine has been injected along the nerve sheath

Patients were randomly assigned to tow groups: infrainguinal ultrasound guided iliaca fascia block (FIBSI) and femoral nerve block (FNB) for FIBSI,the probe is placed transversely between the EIAS and the pubic spine,The transducer is translated laterally to identify the sartorius muscle. Cephalic inclination of the probe: The iliac muscle is located at the medial border in the shadow of the superior anterior iliac spine.The medial end of the transducer faces towards the umbilicus, which is the final position.

The anatomy identified, from superficial to deep, consisting of subcutaneous fat, internal oblique muscle, transverse abdominal muscle, iliaca fascia covering the iliac muscle. The 100mm neurostimulation needle is advanced in In Plan approach to cross the iliaca fascia. With the tip of the needle just below the iliaca fascia, 2 ml of local anesthetic was injected to confirm the location of the tip. Once the correct position is confirmed, 30 ml of 1% Ropivacaine is gradually injected between the iliac fascia and the iliac muscle.

for FNB,The probe was placed under the inguinal ligament. Femoral vessels and sectional nerve are visualized. The nerve was located, an 100mm neurostimulation needle is advanced in In Plan approach, and 30 ml of 1% Ropivacaine was injected along the nerve sheath.

Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anesthesiologists) class I, II, and III patients scheduled for emergency surgery with the diagnosis of proximal femur fracture

Exclusion Criteria:

* hemorrhagic diathesis,
* peripheral neuropathies,
* allergy to amide local anaesthetics,
* mental disorders,
* those on analgesics within 8 hour prior to performing nerve block
GW572016, An Oral Drug For Colorectal Cancer Patients Having Prior Therapy With 5-FU Plus CPT-11 And/Or Oxaliplatin

The purpose of this study is to determine the efficacy of an oral investigational drug in patients with refractory metastatic colorectal cancer after receiving prior therapy with 5-fluorouracil in combination with irinotecan and/or oxaliplatin.


Eligibility Criteria:
Inclusion Criteria:

* Provide signed informed consent.
* Refractory Stage IV metastatic colorectal cancer.
* Received at least 2 cycles of first-line therapy with intravenous 5-FU (5-fluorouracil) in combination with CPT-11 (irinotecan) and/or oxaliplatin.
* No more than one prior therapy.
* Tumor tissue available for testing.
* 4 weeks since first-line cancer regimen.
* Able to swallow and retain oral medication.
* Cardiac ejection fraction within the institutional range of normal as measured by MUGA (Multiple Gated Acquisition Scan).
* Adequate kidney and liver function.
* Adequate bone marrow function.

Exclusion Criteria:

* Pregnant or lactating female.
* Conditions that would affect absorption of an oral drug
* First-line regimen did not include 5-fluorouracil with irinotecan and/or oxaliplatin.
* Serious medical or psychiatric disorder that would interfere with the patient''s safety or informed consent.
* Severe cardiovascular disease or cardiac (heart) disease requiring a device.
* Active infection.
* Brain metastases.
* Concurrent cancer therapy or investigational therapy.
* Use of oral or intravenous steroids.
* Unresolved or unstable, serious toxicity from prior therapy.
* Prior therapy with an EGFR (Endothelial Growth Factor Receptor) and/or erbB-2 inhibitor.
Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace

This project will examine the impact of very low nicotine content (VLNC) cigarettes in a complex tobacco and nicotine product marketplace. We will compare the number of cigarettes smoked and cigarette-free days in an experimental marketplace that contains VLNC cigarettes versus normal nicotine content (NNC) cigarettes.

This randomized, open label, controlled, multi-site study will simulate a "real world" tobacco environment by providing participants access to an experimental marketplace where they will be given vouchers for a specified number of points that can be exchanged for study cigarettes (varying in nicotine content described below) and non-combusted tobacco/nicotine products (smokeless tobacco, snus, electronic cigarette, medicinal nicotine replacement) and at the end of the study can exchange unspent points for money.

Subjects (N=200 in each group) will be randomly assigned to: 1) very low nicotine content cigarettes (VLNC; 0.4 mg nicotine/g tobacco) along with non-combusted tobacco/nicotine products or 2) normal nicotine content cigarettes (NNC; 15.8 mg nicotine/g tobacco) along with non-combusted tobacco/nicotine products.

Smokers will undergo an orientation visit for screening and then enter a three phase experimental trial:

1. Phase 1 - Baseline: Two week baseline assessment period during usual brand cigarette smoking.
2. Phase 2 - Marketplace Adaptation: Two week period where subjects have access to the marketplace that provides their preferred usual brand cigarettes and selected non-combusted tobacco products to allow the subject to adjust to the marketplace prior to randomization;
3. Phase 3 - Intervention: Randomization to a marketplace with access to either VLNC or NNC cigarettes plus non-combusted products for a 12 week period.

Biomarker samples are collected at baseline, end of Phase 2 and end of week Phase 3 (week 12).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female;
2. 18/21 (legal age to purchase tobacco at site);
3. Biochemically confirmed smoker.

Exclusion Criteria:

1. Unstable health condition;
2. Unstable medications;
3. Pregnant or nursing.
Risk Stratification in Children and Adolescents With Primary Cardiomyopathy

RIKADA is a prospective study performing systematic family screening including clinical and genetic testing in pediatric patients with primary cardiomyopathy and their first-degree relatives with the aim to facilitate risk stratification.

RIKADA is a long-term prospective study performing in-depth phenotype and genotype characterization in children and adolescents with primary cardiomyopathy and their first-degree family members. Family screening contains complete cardiac work-up with medical history, physical examination, 12-lead-/Holter-electrocardiogram, cardiopulmonary exercise testing, echocardiography, cardiovascular magnetic resonance (CMR) and laboratory including genetic testing. The aim is to facilitate early identification of at-risk individuals and contribute to patient-specific follow-up and therapy regimes preventing progressive heart failure and arrhythmia in pediatric CMP.

Eligibility Criteria:
Inclusion Criteria:

1. Index patients:

   * Age ≤18 years
   * written informed consent of parents/legal guardians
   * diagnosis of primary cardiomypathy:
   * DCM: left ventricular (LV) systolic dysfunction and dilatation greater than two standard deviations (SD) above the mean of a normal population
   * HCM: LV hypertrophy and septal wall thickness above two SD
   * RCM: diastolic dysfunction and concordant atrial enlargement
   * LVNC: separation of the myocardium into a compacted (C) and a non- compacted (NC) layer with an NC/C ratio \>2 in echocardiography and/or \>2.3 in CMR
   * ARVC: according to the revised Task Force Criteria
2. First-degree family members (parents and siblings):

   * Age ≥3 years
   * written informed consent of parents/legal guardians and siblings ≥18 years

Exclusion Criteria:

* unwillingness to give consent
* myocardial inflammation / myocarditis
* systemic disease with cardiac involvement (secondary cardiomyopathy)
* structural congenital heart disease