cyrilzakka/clinical-trials huggingface dataset:
A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV

Asian Americans have the highest incidence, mortality and prevalence rates of hepatocellular carcinoma (HCC) among all U.S. racial and ethnic groups. The goal of this study is to investigate the efficacy of a Patient Navigator-led mobile phone text Messaging Intervention (PNMI) in improving hepatitis B follow-up care management for Asian Americans with chronic hepatitis B infection through a randomized controlled trial.

Asian Americans have the highest incidence, mortality and prevalence rates of hepatocellular carcinoma (HCC) among all U.S. racial and ethnic groups. Inadequate chronic hepatitis B (CHB) monitoring and care are also likely to contribute to poorer outcomes and increased healthcare costs. The goal of this study is to investigate the efficacy of a Patient Navigator-led mobile phone text Messaging Intervention (PNMI) in improving hepatitis B follow-up care management for Asian Americans with chronic hepatitis B infection through a randomized controlled trial. The primary outcome of the study is Asian CHB patient adherence (measured as "having seen a doctor for CHB monitoring") to hepatitis B (HBV) monitoring guidelines at 6-month and 12-month assessments post-intervention.

Patient partners and stakeholders were engaged in all study stages. The findings of this study provided unique and promising opportunities for broadly disseminating and implementing the evidence-based intervention in the real-world practice, thus further preventing chronic liver diseases and reducing health disparities among high-risk underserved populations.

Eligibility Criteria:
Inclusion Criteria:

1. self-identified Chinese, Korean and Vietnamese ethnicity
2. age 18 and above
3. accessible by telephone with text message feature
4. presence in the same geographic study area for a period of one year
5. not enrolled in any chronic HBV adherence management intervention
6. medically diagnosed chronic HBV infection with positive for hepatitis B surface antigen (HBsAg) for more than six months, and
7. Never or non compliant with HBV monitoring guidelines.

Exclusion Criteria:

Patients were excluded from the study for the following conditions:

1. diagnosed with cirrhosis, hepatocellular carcinoma, liver failure and liver cancer
2. concurrent hepatitis C infection, and
3. concurrent HIV infection
A Study to Assess Adverse Events and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Adult Participants With Glaucoma

Glaucoma is the second most common cause of blindness in the world, second only to cataracts. This study will assess how safe and effective a glaucoma gel stent is when implanted using the ab interno (inside the eye) and ab externo (outside the eye) approach. Adverse events and intraocular pressure will be assessed.

XEN63 is an investigational device for the treatment of intraocular pressure (IOP) in patients with glaucoma when both medical and conventional surgical treatments have failed (for US approval) and when medical treatments have failed (for outside US \[OUS\] approval). Participants will be placed in one of two groups called study arms. One group will receive the XEN63 gel stent ab interno (inside the eye) and the other group will receive the XEN63 gel stent ab externo (outside the eye). Approximately 130 participants aged 45 years or older with glaucoma will be enrolled in this study at approximately 32 sites in select countries in North America and Europe.

Participants will receive XEN63 implanted using either the ab interno approach or the ab externo approach on Day 1 and will be followed for 12 months.

Participants will attend regular visits during the study at a hospital or clinic. The safety and effect of the gel stent on your glaucoma will be checked by medical assessments and eye examinations.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of glaucoma in the study eye (SE) (meeting criterion a or b)

  1. That meets the following refractory glaucoma criteria of eyes diagnosed with glaucoma uncontrolled by maximal medical therapy (four or more classes of intraocular pressure (IOP)-lowering medications, or fewer in cases where it has been documented that certain medication classes cannot be tolerated or are contraindicated), and failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery, tube shunt)
  2. Uncontrolled by medical therapy (to meet out-of-US \[OUS\] requirements) with participants who only have glaucoma uncontrolled by medical therapy (non-refractory glaucoma), a maximum of 10 participants who meet only criterion b (and not a) will be enrolled in each cohort.

     Exclusion Criteria:
* History of angle-closure glaucoma where the angle has not been surgically opened in the SE.
* History of secondary open-angle glaucoma (e.g., neovascular, pigmentary, pseudoexfoliative, uveitic, angle recession/traumatic glaucoma, etc.) in the SE.
* Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis) in the SE.
Acute and Long Term Effects of VNS on Memory in Patients With Refractory Epilepsy

Refractory epilepsy patients implanted with a vagus nerve stimulator perform a memory test at baseline in three conditions: invasive vagus nerve stimulation (VNS), transcutaneous vagus nerve stimulation (taVNS) and sham stimulation. After 6 weeks of VNS treatment, the memory test is repeated in two condition: invasive vagus nerve stimulation (VNS) and sham stimulation.

The endpoint of this experiment is assessing the effect of VNS and taVNS on memory performance.

Previous studies underlined the potential of both invasive as transcutaneous auricular vagus nerve stimulation to ameliorate certain cognitive functions.

In this randomized, controlled cross-over within-subjects study, a memory test is conducted in patients with refractory epilepsy who are implanted with a vagus nerve stimulation.

The memory test consists out of a word recognition paradigm based on the study of Clarck et al. published in 1999 in Nature Neuroscience. Testing is performed at baseline (before start of the stimulation) and after 6 weeks of treatment with vagus nerve stimulation.

During the first session, the patients complete the word recognition task during three interventions:

* Invasive vagus nerve stimulation
* Transcutaneous vagus nerve stimulation (cymba concha)
* Sham vagus nerve stimulation (no stimulation)

During the second session, the patients complete the word recognition task during two interventions:

* Invasive vagus nerve stimulation
* Sham vagus nerve stimulation (no stimulation)

The goal is to investigate if invasive vagus nerve stimulation and transcutaneous nerve stimulation can influence (i.e. improve) the performance on the memory task and if this performance is improved after 6 weeks of VNS treatment.

Eligibility Criteria:
Inclusion Criteria:

* Refractory epilepsy
* Treated with vagus nerve stimulation
* IQ \>= 70 and able to perform the memory task

Exclusion Criteria:

* IQ \< 70
Total Thyroidectomy With Harmonic Scalpel®

Harmonic scalpel is a new surgical instrument. Its use has been recommended in patients submitted to total thyroidectomy. Few randomized controlled trials has been published. However they had small sample sizes, used intermediate outcomes and included different surgical procedures.

Our objective is to asses the use of Harmonic scalpel in patients submitted to total thyroidectomy using surgical complications, operative time, drainage volume, postoperative pain, length of stay and costs as outcomes. Our hypothesis is that Harmonic scalpel decreases operative time,drainage volume, postoperative pain, length of stay and costs without increasing surgical complications

This is a multicentric open phase IV randomized controlled trial comparing patients submitted to total thyroidectomy comparing standard surgical procedure versus Harmonic scalpel assisted procedure. Adult patients with benign or malignant thyroid disease and normal function will be included. Patients with giant goiter, hyperthyroidism, non differentiated thyroid carcinoma, locally invasive tumors, neck dissection, previous neck radiotherapy or chemotherapy, video assisted surgery and severe comorbidities will be excluded. calculated sample size was 280 patients. Outcomes will be assessed by an independent monitor. All centers will made a previous standardization of surgical procedures.

Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 y/o)
* Benign or malignant thyroid disease
* Proposal of total thyroidectomy
* Normal thyroid function

Exclusion Criteria:

* Giant goiter
* Hyperthyroidism
* Non differentiated thyroid carcinoma
* Locally invasive tumors
* Neck dissection as a part of procedure
* Previous surgery, radiotherapy or I131 therapy on neck
* Video-assisted or endoscopic thyroidectomy
* Severe comorbidities
* Coagulation disorders
Study of Freeze-dried Black Raspberry in Maintenance of Ulcerative Colitis

This research study is about adding Black Raspberry powder to the treatment regimen of patients with ulcerative colitis who are currently in remission and doing well.


Eligibility Criteria:
Inclusion Criteria:

Adult patients (\>18 years of age) with known diagnosis of ulcerative colitis who are currently in remission on a stable dose of 5-ASA products and/or steroids (equivalent to prednisone 20 mg or less). English speaking/reading male or female patients from all ethnicities will be considered for the study.

Exclusion Criteria:

* Treatment with Immunomodulators and/or biologic agents, active disease flare, patients younger than 18 years old, patients who are pregnant or trying to get pregnant, breast feeding and those with reported history of allergy or hypersensitivity to berry products.

Patients who are using NSAIDS will also be excluded from the study but low dose ASA (81-162 mg) is permitted if needed.
S-1 and Irinotecan Combination Chemotherapy for Advanced Gastric Cancer

The primary goal of this phase II trial is to evaluate the response rate of combination chemotherapy with S-1 and Irinotecan in patients with advanced gastric cancer as a first-line therapy.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven unresectable adenocarcinoma of stomach
* With uni-dimensionally measurable disease (at least longest diameter 2 cm on conventional CT scan, x-ray or physical examination, or 1cm on spiral CT scan)
* Age 18 to 70 years old
* Estimated life expectancy of more than 3 months
* ECOG performance status of 2 or lower
* Adequate bone marrow function(absolute neutrophil count \[ANC\] ≥1,500/µL, hemoglobin ≥9.0 g/dL,and platelets ≥100,000/µL)
* Adequate kidney function (serum creatinine \< 1.5 mg/dL)
* Adequate liver function (serum total bilirubin \< 2 times the upper normal limit (UNL); serum transaminases levels \<3 times \[\<5 times for patients with liver metastasis\] UNL)
* No prior chemotherapy but prior adjuvant chemotherapy finished at least 6 months before enrollment was allowed. (but, prior adjuvant chemotherapy with capecitabine or S-1 or camptothecin analogues was excluded)
* No prior radiation therapy for at least 4 weeks before enrollment in the study

Exclusion Criteria:

* Other tumor type than adenocarcinoma
* Central nervous system (CNS) metastases or prior radiation for CNS metastases
* Gastric outlet obstruction or intestinal obstruction
* Evidence of gastrointestinal bleeding
* The patient has bony lesions as the sole evaluable disease.
* Past or concurrent history of neoplasm other than stomach cancer, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
* Pregnant or lactating women, women of childbearing potential not employing adequate contraception
* Other serious illness or medical conditions

  * Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
  * History of significant neurologic or psychiatric disorders including dementia or seizures
  * Active uncontrolled infection
  * Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
* Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy
* concomitant drug medication; The following drugs cause drug interaction with S-1.

  i. Warfarin, phenprocoumon: increase bleeding tendency ii. Increase blood concentration of phenytoin iii. sorivudine: inhibit DPD -\> increase toxicity according to fluoropyrimidine iv. allopurinol : decrease activity of S-1
Clinical Trial to Evaluate ANT-1401 in Crow's Feet

The purpose of this study is to confirm the effect of ANT-1401 in the treatment of Lateral Canthal Lines.


Eligibility Criteria:
Inclusion Criteria:

* 30 - 60 years of age
* mild to moderate Crow's Feet wrinkles (IGA 1-2) at rest
* moderate to severe Crow's Feet (IGA 2-3) on contraction
* moderate to severe Crow's Feet (SSA 2-3) on contraction
* Have adequate vision to assess facial wrinkles in a mirror

Exclusion Criteria:

* botulinum toxin treatment in the prior 6 months
* history of periocular surgery, brow lift or related procedures
* soft tissue augmentation in the lateral canthal region in the prior 12 months
* dermabrasion or laser treatment in the periocular region in the last 6 months
* topical prescription-strength retinoids in the prior 3 months
* present or history of neuromuscular disease
* present or history of "dry eye"
* systemic aminoglycoside use in the week prior to treatment application
Efficacy and Safety Study of GX-I7 Plus Adjuvant Temozolomide Combination in Patients With Newly Diagnosed Glioblastoma

This is a phase 1/2, randomized, placebo-controlled study to evaluate safety, tolerability, anti-tumor activity and impact on absolute lymphocyte count of GX-I7 plus adjuvant temozolomide combination regimen in patients with newly diagnosed with glioblastoma who completed standard concurrent chemo-radiation therapy (CCRT)

In dose escalation stage (Phase 1 part), low/intermediate/high dose of GX-I7 will be administered in combination with adjuvant temozolomide to find recommended phase 2 dose.

Phase 2 part will be randomized, placebo controlled study and GX-I7 or Placebo will be administered in combination with adjuvant temozolomide treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent Form (ICF)
2. Age ≥ 19 years
3. Gross total resection equal to or greater than 80% based on post-op MRI, compared to pre-op MRI (Patients requiring biopsy only is not eligible)
4. Patients newly diagnosed with glioblastoma either by imaging or pathology testing, requiring concurrent chemo-radiotherapy (CCRT) and adjuvant temozolomide chemotherapy with curative intent
5. Karnofsky score ≥ 60
6. Life expectancy \> 12 weeks

Exclusion Criteria:

1. Gliomatosis cerebri
2. Isocitrate dehydrogenase 1 \& 2 mutation
3. Pregnant or breast feeding women
Randomized Controlled Clinical Trial of Internal Fixation of Intertrochanteric Fractures of Femur Guided by Conventional Versus IF-AI Artificial Intelligence Program

Our team has developed an AI software to guide the surgical protocol for femoral intertrochanteric fractures. This is a prospective randomized controlled clinical study that will include patients with femoral intertrochanteric fractures combining medial posterior and lateral wall fractures, and will randomly divide the patients into a traditional surgical protocol group and an AI-guided surgical protocol group. The efficacy and safety indexes such as operation time, blood loss, operation cost, infection rate, hospitalization time, postoperative pain score, fracture healing time, internal fixation failure rate and mortality rate were compared between the two groups to verify the efficacy and safety of AI-guided surgical treatment plan.


Eligibility Criteria:
Inclusion Criteria:

1. Over 60 years old, male or female.
2. Osteoporosis intertrochanteric fracture, which met the diagnostic criteria of X-ray intertrochanteric fracture, and osteoporosis T-value \<2.5.
3. Patients with 1mm resolution CT imaging data.
4. Willing to participate in the project, sign the informed consent, and be able to complete the follow-up work.

Exclusion Criteria:

1. Patients with pathological fractures, old fractures, stress fractures, and periprosthesis fractures;
2. Patients lacking 1mm resolution CT imaging data;
3. Severe malnutrition, heavy smoking, alcoholism and other systemic conditions affect fracture healing;
4. Patients with severe medical diseases that cannot be operated on;
5. Patients participating in other clinical studies.
Adults With Attention Deficit Hyperactivity Disorder (ADHD): Validation of a Clinical Interview and Screening Instruments in French

ADHD is a neurodevelopmental disorder that affects about 5% of school-age children and 3.5% of adults worldwide. This condition is under-recognised in France and other European countries and, therefore, under-diagnosed.

As part of the European Network for Adult ADHD, the investigators translated into French a structure interview called the Diagnostic Interview for Adult ADHD (DIVA). The investigators also translated rating scales such as the ASRS and the WURS. Validation studies are rare in France.

The aim of this study is to include two groups of 50 adults whether they have or not ADHD with respect of Diagnostic and Statistical Manual - Revision 4(DSM-IV) criteria as implemented in the DIVA (i.e. actual at adulthood and past in childhood). Subjects have to fill out a booklet of questionnaires including the WHO's Adult ADHD Symptom Rating Scale (ASRS) (screening tool for actual diagnosis) and the Wender Utah Rating Scale (WURS, a screening tool for ADHD in childhood with respect of the Utah criteria). The investigator will be able to compare the actual criteria for ADHD between the ASRS and the DIVA, and the past criteria for ADHD between the WURS and the DIVA. Finally, an estimate of the prevalence of ADHD in adults will be computed.


Eligibility Criteria:
Inclusion Criteria:

* Authorization to use the data signed social security affiliation

Exclusion Criteria:

* Patient presenting a known neurological or psychiatric disorder, or a deficit Intellectual because the attentional disorders(confusions), the psychomotor excitement and The impulsiveness can be symptoms inherent to the other pathologies Neurological and\\or psychiatric.
Respiratory Therapy in COPD Exacerbations

The purpose of this study is to determine effectiveness, feasibility and safety/tolerance of Respiratory Therapy in hospitalized patients with acute exacerbations of chronic obstructive pulmonary disease.

Acute exacerbation of chronic obstructive pulmonary disease (AE-COPD) is defined as an event in the natural course of the disease characterized by a change in the patient's usual symptoms (dyspnea, cough and/or sputum) that may not be explained by the daily variations and requires a change in regular medication.

Because AE-COPD result in impairment of both pulmonary and respiratory muscle functions, as well as an increasing impact on costs, priority should be given to interventions to slow the progression of the disease, prevention of exacerbations and reduce the risk of comorbidity.

Chest physiotherapy is often used in hospitalized patients with AE-COPD with the aim of favoring the removal of secretions and thus to improve the ventilation perfusion (V/Q), and therefore the function lung. The limited scientific evidence has determined that their use is controversial and not routinely recommended in clinical practice guidelines. Current clinical guidelines in the treatment of COPD are unable to rule on the application of respiratory therapy during exacerbations, since there is little scientific evidence of its benefits in the short and long term.

Eligibility Criteria:
Hospitalized patients with acute exacerbation of COPD.

Inclusion Criteria:

* age over 18 years,
* hospitalized patients and
* acute exacerbation of COPD.

Exclusion Criteria:

* Previous history of any chronic respiratory disease and
* not to have performed any kind of general or respiratory training in the previous 3 months.
The Effect of Celecoxib on the Antiplatelet Effect of Aspirin and Clopidogrel in Normal Volunteers

Background:

* The prevalence of arthritis which needs celecoxib prescription is high in patients with coronary artery disease.
* The main concern is that celecoxib would increase thrombogenicity by inhibiting the synthesis of prostacyclin in endothelial cells.
* It is not known whether the administration of celecoxib would deteriorate antiplatelet effects of aspirin and clopidogrel which are used after stenting.

Methods:

* Healthy volunteers (n=40)
* Randomization into five subgroups
* aspirin, celecoxib, aspirin+celecoxib, aspirin+clopidogrel, aspirin+clopidogrel+celecoxib
* Medication schedule : medication of each drug for 6 days, blood samples at day 0 and day 7
* Celecoxib 200mg twice a day, and/or aspirin 100mg daily, and/or clopidogrel 75 mg daily
* Platelet function test : light transmittance aggregometry and arachidonic acid metabolite assay among subgroups.

Study hypothesis : The addition of celecoxib does not deteriorate antiplatelet function of aspirin and clopidogrel.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers including both men and women 20\~30 years
* no abnormality in physical examination, 12-lead ECG, and routine laboratory test

Exclusion Criteria:

* Subjects with cardiovascular disease, hemostatic disorder, hypersensitivity to NSAIDs and clopidogrel
* Women with a positive pregnancy test
* smoker
* chronic drinkers
* overweight exceeding 20% of standard body weight
A Clinical Trial of Infliximab for Uveitis

This project is designed to test the hypothesis that inhibition of binding between tumor necrosis factor alpha (TNF-alpha) and its receptors using Remicade (infliximab, chimeric mouse/human IgG1K monoclonal antibody directed against human TNF-alpha, Centocor, Malvern,PA) is clinically useful for patients with uveitis that is refractory to other forms of systemic immunosuppressive therapy.


Eligibility Criteria:
Inclusion Criteria:

1. The study group will include patients suffering from treatment-resistant vision-threatening uveitis who attend the Uveitis Clinic at Casey Eye Institute.
2. We plan to enroll 32 patients.

Exclusion Criteria:

1. Patients with ocular or systemic infection.
2. Patients with the subtype of uveitis termed pars planitis who have MRI scan evidence of demyelination. There is a theoretical risk of adverse outcome of TNF-alpha inhibition on the clinical course of multiple sclerosis. Patients who suffer from pars planitis are at increased risk of developing multiple sclerosis.
3. Children under the age of 9.
4. Patients with known sensitivity to mouse proteins. Remicade is a chimeric protein with human and murine components.
5. Patients with history of cancer (exception- skin cancers which are curatively resected), organ transplantation (exception- cornea), recent drug or alcohol addiction, or inability to keep appointments.
6. Patients with other serious systemic diseases that could interfere with participation in the study.
7. It is specifically noted that pregnant women and nursing mothers will be excluded from this study.