cyrilzakka/clinical-trials huggingface dataset:
Polyp Measurement Device

Colorectal cancer is the second-leading cause of cancer death in the United States. Colorectal cancer screening is recommended to begin at age 50 years for most men and women at average risk for this disease. Colonoscopy is a gold standard method of screening for colorectal cancer, allowing for the detection and removal of colorectal polyps, some of which can progress into malignancy. The literature has shown that the removal of polyps during a colonoscopy results in decreased incidence and mortality related to colorectal cancer. Indeed, the last decade has shown a decline in colorectal cancer incidence and mortality in adults over age 50, largely due to increased colonoscopy screening. Currently, the risk of a patient developing colorectal cancer and thus time intervals for colonoscopy surveillance post-polypectomy is determined by the number, pathology, and size of the polyps that are observed and removed during the colonoscopy procedure. Current surveillance guidelines indicate the need for a shorter interval before the next colonoscopy for patients who have one or more polyps that are 10mm or larger. In addition, different polypectomy techniques are indicated for the treatment of polyps less than 20mm in size. For example, cold forceps may be appropriate for removal of 1mm to 2mm polyps, cold snare for polyps less than 10mm, and hot-snare resection for polyps 10mm to 19mm. Yet, while the number and pathology of polyps are easily obtained and verified, it is standard practice for the size of a polyp to be assessed through endoscopist optical visualization alone, without use of an objective device or standard by which to measure it. Often, the endoscopist will compare the size of the polyp to the size of the snare loop to estimate and document the size of the polyp(s). However, with the size of a polyp being a major indicator of malignant potential as well as an indicator of appropriate polypectomy technique and surveillance intervals, a device with which to take and document accurate and objective measurements of polyps during colonoscopy holds the potential for health benefits. In addition to having a potential clinical benefit for each patient in terms of polypectomy and surveillance intervals, as an objective indicator of polyp size, this technique also holds promise for use in future studies that evaluate polyp size as an indicator of potential malignancy (or future malignancy) and for use by national clinical guidelines committees who may utilize these objective data to update future screening and surveillance recommendations.


Eligibility Criteria:
Inclusion Criteria:

* Individuals age 50-85 years old, who require an outpatient screening or surveillance colonoscopy
* Ability to give consent

Exclusion Criteria:

* Pregnancy
* Inflammatory bowel disease
Dexmedetomidine and Bupivacaine Intra-articular for Postoperative Analgesia After Knee Arthroscopic Surgery

The aim of this study to compare the analgesic effects of intraarticular dexmedetomidine added to bupivacaine with those of bupivacaine alone after knee arthroscopy

prospective double-blind study perform on 75 patients candidates for anterior cruciate ligament (ACL) reconstruction by knee arthroscopy refer to the clinic of Al Azhar University Hospital, Assiut, Egypt, to evaluate the effect of adding dexmedetomidine to intra articular bupivacaine injection on postoperative pain after knee arthroscopy.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients
* Either sex
* Aged 18-65 years
* Candidates for anterior cruciate ligament (ACL) reconstruction by knee arthroscopy
* Exclusion Criteria:
* the patients with kidney failure, liver failure, valvular and ischemic heart disease , high blood pressure, diabetes, history of infection and malignancy.
* history of coagulation diseases, and history of drug allergies to used drugs.
* those who consumed NSAIDs and analgesics 24 h before surgery were excluded from the study.
Genicular Radiofrequency Ablation Efficacy in Achieving Total Knee Pain Reduction Trial

Given the benefits of genicular nerve radiofrequency ablation (RFA) in improving pain and functional status in non-surgical patients with knee osteoarthritis as well as the high prevalence of postoperative pain from total knee arthroplasty (TKA), this study is designed to determine the efficacy of preoperative genicular nerve RFA in improving acute and chronic postoperative pain as well as functional status in patients undergoing TKA. Patients will be randomized to one of two study arms: RFA group (genicular nerve thermal RFA) or control group (RFA needles placed in proper location without effective neurotomy).

Total knee arthroplasty (TKA) is a common and effective treatment for severe knee osteoarthritis. As the average age of the population increases in developed countries, the number of TKAs performed is projected to increase to 3.48 million procedures per year by 2030, a 673% increase from 2005. Although TKA is widely accepted as an efficacious form of treatment for severe knee osteoarthritis, the incidence of patient dissatisfaction and postoperative pain cannot be ignored. Genicular nerve RFA has been performed in non-surgical patients with chronic knee osteoarthritis with significant post procedure improvement in pain and functional status. This study is designed to determine the efficacy of preoperative genicular nerve RFA in improving acute and chronic postoperative pain as well as functional status in patients undergoing TKA.

Eligibility Criteria:
Inclusion Criteria:

* Surgical candidate for total knee arthroplasty secondary to osteoarthritis
* Radiologic tibiofemoral osteoarthritis (Kellgren-Lawrence grade 2-4)

Exclusion Criteria:

* Worst knee pain score on day of evaluation \<4/10
* Already taking opioids \>100 mg/day of morphine equivalent dose
* Infectious etiology (over RFA insertion site or systemic)
* Workers compensation
* History of adverse reaction to local anesthetic or contrast
* History of intraarticular injection in the last 6 weeks with steroids or hyaluronic acids
* Prior total knee arthroplasty
* Prior open knee surgery or ligament reconstruction
* Prior RFA of knee joint
* Connective tissue diseases affecting the knee
* Sciatic pain
* Pacemaker
* Pregnancy
* Severe medical disease
* Serious neurological disorders
* Serious psychiatric disorders
* Suicidal or homicidal ideation
* BMI\>50
Comparison of Efficacy Different Treatment Regimens in Pulmonary Hypertension Secondary to Lung Disease and or Hypoxia

This is an open label, randomized, interventional study indented to find the efficacy of different treatment regimens in treatment of pulmonary hypertension secondary to lung disease and/or hypoxia.This is to find out when to start combination therapy (sildenafil plus bosentan) in treatment of pulmonary hypertension secondary to lung disease and/or hypoxia.

This is an open label, randomized, interventional study indented to find the efficacy of different treatment regimens in treatment of pulmonary hypertension secondary to lung disease and/or hypoxia. It involves 3 arms, one getting monotherapy with sildenafil for 6 months, 2nd getting bosentan monotherapy initially for 3 months and then combination of sildenafil and bosentan for 3 months, 3rd getting combination sildenafil and bosentan from the beginning for 6 months. The aim is to decide when is the best time to start combination therapy either from start or at the time of drug failure. Improvement will be assessed by change in functional class, pulmonary pressures measured by ECHO, pulmonary function test, six minute walk test and biochemical markers. Lack of randomized trials and Indian data is there on the subject. Also adverse events and serious adverse events will be closely monitored and reported to the ethics committee and DCGI immediately.

Eligibility Criteria:
Inclusion Criteria:

1. Pulmonary artery hypertension diagnosed by doppler echocardiography as mean pulmonary artery pressure 25 mmHg (done in department of cardiology, AIIMS)
2. Age more than 18 years
3. Pulmonary artery hypertension due to hypoxia, either chronic obstructive airway disease or diffuse pulmonary lung disease
4. Willing to consent to participate in the trial
5. WHO functional class I,II, III

Exclusion Criteria:

1. WHO functional class IV
2. Patient participating in any other trial
3. Concomitant coronary artery disease
4. Nitrate intake
5. Liver dysfunction
6. Pregnancy and lactation -
DM-IMT - Controlled, Randomized, Three-arm Intervention Study on the Safety and Efficacy of Regular Respiratory Muscle Training in Patients With Myotonic Dystrophy Type 1

For some diseases, regular respiratory muscle training could delay the start of ventilation. For DM1, however, there are no clinically high-quality studies. Only a case description from the year 2006 showed a missing improvement of the symptoms after respiratory muscle training in one patient, accordingly there are no recommendations in this issue. Within the scope of this monocentric, three-arm, controlled intervention study, 45 patients with genetically confirmed type 1 myotonic dystrophy will be randomized in three groups of 15 patients each, age-, gender- and symptom-corrected by the MUSCULAR IMPAIRMENT RATING SCALE (MIRS). The DM1 patients will receive regular respiratory muscle training for a period of 9 months. The aim of this study is to evaluate the safety and effectiveness of regular inspiratory strength-breathing muscle training on 15 patients, the safety and effectiveness of regular inspiratory endurance respiratory muscle training on 15 patients, and the comparison to the natural course in 15 patients without training. Subsequently, we will provide treatment recommendations for respiratory training in DM1.


Eligibility Criteria:
Inclusion Criteria:

* the patient is willing and able to provide a signed informed consent form
* the patient is ≥ 18 years old
* the diagnosis of type 1 myotonic dystrophy has been confirmed by molecular genetics
* the patient is able and willing to perform pulmonary function tests (PFT) and blood sampling for capillary blood gas analysis (pO2, pCO2) throughout the study, to keep a diary and to complete questionnaires

Exclusion Criteria:

* the patient requires invasive ventilation (non-invasive ventilation is allowed).
* the patient uses non-invasive ventilation more than 16h/day.
* the patient participates in another clinical study that involves therapy.
* the patient cannot perform pulmonary function tests (PFT).
* the patient is diagnosed with central sleep apnea in polysomnography and not sufficiently treated with NIV ventilation.
* the patient is diagnosed with obstructive sleep apnea and not sufficiently treated with NIV ventilation.
* the patient cannot meet the requirements of the study, according to the investigator.
* the patient is unable to complete a 6-minute walking test
Web-based CBT4CBT for Alcohol

The investigators are conducting a randomized clinical trial of our new web-based version of the CBT4CBT (Computer Based Training for Cognitive Behavioral Therapy) program specifically designed for alcohol to evaluate its effectiveness relative to standard outpatient counseling at the Substance Abuse Treatment Unit (SATU). The computer-based training program (CBT4CBT) focuses on teaching basic coping skills, presenting examples of effective use of coping skills in a number of realistic situations in video form, and providing opportunities for patients to practice and review new skills while receiving substance abuse treatment.

Ninety alcohol using individuals seeking treatment at the Substance Abuse Treatment Unit (SATU) of the Connecticut Mental Health Center will be randomized to (1) standard outpatient counseling at SATU (typically consisting of weekly group counseling), (2) standard outpatient counseling plus web-based CBT, or (3) web-based CBT4CBT with minimal clinical monitoring. Treatments will be delivered over an 8-week period with a six-month follow-up after termination of the study treatments. The primary outcome measures will be reduction in alcohol use (frequency of alcohol use by time, confirmed by urine toxicology screens and breathalyzers). Secondary outcomes will include treatment utilization and cost, several measures intended to detect whether web-based CBT4CBT retains key characteristics of traditional clinician-administered CBT (e.g., acquisition of coping skills, use of change strategies), participant characteristics which will be evaluated as potential moderators of outcome, as well as participant satisfaction and treatment credibility.

Eligibility Criteria:
Inclusion Criteria:

* Are 18 years of age or older.
* Are applying for outpatient, non-agonist substance abuse treatment at SATU.
* Meet current DSM-IV criteria for alcohol abuse or dependence.
* Are sufficiently stable for 8 weeks of outpatient treatment.
* Can commit to 8 weeks of treatment and are willing to be randomized to treatment
* Are willing to provide locator information for follow-up.
* Are fluent in English and have a 6th grader or higher reading level

Exclusion Criteria:

* Have an untreated bipolar or schizophrenic disorder.
* Who have a current legal case pending such that incarceration during 8-week protocol is likely.
* Are physically dependent on alcohol, opioids or benzodiazepines
Coronavirus Infection in Primary or Secondary Immunosuppressed Children and Adults.

A weekly questionnaire is sent to patients and parents of patients who are vulnerable for infections. Possible symptoms of COVID19 are asked for and use of healthcare services and testing for COVID19. Weekly reports are being send to the national institutions to update advice given to this group.

This study is designed to allow immunosuppressed children, their parents or adult patients to self-record their experiences of COVID-19 and other viral respiratory illnesses. Patients, parents and of immunosuppressed patients and patients aged 16-17 yrs will be provided with online information and asked to fill in online questionnaires at baseline and weekly thereafter. Information collected includes medication, symptoms, contact with health care providers, test results and impact on daily activities. Data will be collected and analysed weekly to be able to monitor any potential risk factors for severe disease. This study is complementary to, and not overlapping with, the global ISARIC World Health Organisation protocol that will be studying COVID-19 cases admitted to all National Health Service (NHS) Trusts, including all children.

Eligibility Criteria:
Inclusion Criteria:

* Children part: Parent of immunosuppressed patient aged \<16 years or immunosuppressed patient aged 16-17 years
* Adult part: Immunosuppressed patient aged \>17 years
* Family or themselves able to complete the questionnaire which will be in English (due to current resources available translation will not be possible)
* Reliable access to the internet

Exclusion Criteria:

* Unable to understand English
The Analysis for Termination of Treatment and Satisfaction in Traffic Accident Patient

Data of one hospital will be used to find out the patient's satisfaction with the treatment, analyze the factors effecting on the treatment termination.

Also, plan to see if there is a correlation between prognosis according to the seriousness of the accident. In addition, investigators want to find out the participants' perception of car insurance and their satisfaction with traditional Korean medicine treatment.

Retrospective data will be extracted using electronic medical records and computerized data of hospitalized patients. Based on this, investigators will conduct research in the form of prospective survey and analyze the causal relationship and factors using the two data.

The hospital's medical records will be used to analyze the patient's condition during the hospitalization period and to determine the situation after the end of treatment through questionnaire. The questionnaire will be developed after consultation with experts from musculoskeletal system and related societies, and will be used for the questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Age 19 to 65
* A traffic accident injury patient who had been hospitalized at Haeundae Jaseng Korean Medicine Hospital from Jan. 01, 2016 to Dec. 31, 2018.

Exclusion Criteria:

* People whose traffic accidents are not yet agreed to
* Those who have not exceeded 90 days (3 months) since the conclusion of the agreement
* Persons unable to communicate
Study of Low-dose Naltrexone in Chronic Migraine With Fibromyalgia

This research aims to look at the effect of low-dose naltrexone on the severity and frequency of attacks in people with chronic migraine with or without new daily persistent headache and fibromyalgia. A few studies suggest low-dose naltrexone is effective for fibromyalgia, but it has not been studied in patients with migraine and headaches. Our goal is to see if there is an improvement in either severity and frequency of attacks and overall impact on quality of life over a three-month period.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be adults of all genders ages 18 and older.
* Patients with a diagnosis of CM (with or without NDPH) by IHC-3 criteria, diagnosed by a certified headache specialist.
* Subjects who received a new prescription for LDN
* Fibromyalgia-diagnosed according to Fibromyalgia Rapid Screening Tool
* Subjects should be on stable headache and migraine preventives for the past 2 months with no plans to change medication for the next 4 months.
* Subjects willing to maintain a headache/migraine diary one month prior to taking medication and while taking the medication, either physical or electronic diary of their choice.
* Subjects willing to fill out pre and post intervention surveys
* Subjects willing to comply with planned follow up phone calls and visits.

Exclusion Criteria:

* Not planning on follow up care with clinician.
* Patients with decreased decision-making capacity in which the investigator's opinion would interfere with the person's ability to provide informed consent and complete study questionnaires.
Repetitive Transcranial Magnetic Stimulation

The study is a prospective, randomized, double-blind sham-controlled study.

The principal objective of this trial is to investigate the effect of left prefrontal high frequency rTMS on negative symptoms in schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria for schizophrenia
* age between 18 and 60
* informed consent
* right handed patient
* no change of antipsychotic treatment \> 2 weeks before recruitment

Exclusion Criteria:

* seizures, epilepsy
* history of severe head injury
* status post implantation of a cardiac pacemaker or other electronic devi-ses
Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X Syndrome

There will be four study periods: Screening (up to 14 days in length), the Treatment Period (8 weeks), the Withdrawal Period (22 days), and Follow-up Period (up to 31 days). Subjects will be randomized to receive either STX209 (5 mg twice daily \[BID\], 10 mg BID or 10 mg three times daily \[TID\]) or placebo. Efficacy,safety and tolerability assessments will be performed periodically


Eligibility Criteria:
Inclusion Criteria:

* Molecular documentation of the full FMR1 mutation
* Current pharmacological treatment regimen has been stable for at least 4 weeks prior to Screening.
* Subjects with a history of seizure disorder must currently be receiving treatment with antiepileptics and must have been seizure free for 6 months, or must be seizure free for 3 years if not currently receiving antiepileptics.
* If the subject is already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, participation in these programs must have been continuous during the 2 months prior to Screening

Exclusion Criteria:

* Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.
* Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
* Subjects who have taken another investigational drug within the last 30 days.
* Subjects who are not able to take oral medications
A Phase II Study of Cabozantinib (XL184) Therapy in Castrate Resistant Prostate Cancer (CRPC) With Visceral Metastases

This research study is being done to measure the clinical benefit associated with cabozantinib (XL184) in men who have prostate cancer that has spread to visceral organs (organs other than bone or lymph nodes) and no longer responds to initial hormonal (castration) therapy. This type of prostate cancer is called metastatic, castrate-resistant prostate cancer.

Cabozantinib (XL184), a multi-targeted tyrosine kinase inhibitor, has demonstrated a powerful clinical phenotype in men with metastatic castrate resistant prostate cancer (mCRPC) both before and after chemotherapy. This phenotype consists of rapid reduction in pain (when present) and improvement in bone scans that may or may not be accompanied by decrease in serum prostate specific antigen (PSA) concentrations. In previous studies of cabozantinib in advanced prostate cancer, patients with visceral disease have been excluded. Hence, this protocol creates a unique opportunity to define the activity of this disease in the population of men with visceral disease - a marker for poorer prognosis in mCRPC.

Primary Objectives:

- To assess the clinical benefit (complete response + partial response + stable disease) of cabozantinib in patients with mCRPC with visceral metastases.

Secondary Objectives:

* To assess the impact of cabozantinib on numbers live circulating tumor cells (CTCs) using NanoVelcro Chips
* To test the feasibility of measuring variation in gene expression in circulating tumor cells (CTCs) in response to therapy.
* To determine if there is an impact of cabozantinib on live circulating tumor cell (CTC) number and patterns of gene expression.
* To measure the impact of cabozantinib on serum HGF (hepatocyte growth factor) and VEGF (vascular endothelial growth factor) levels in men with metastatic, castration-resistant prostate cancer (mCRPC).
* To assess the safety and tolerability of lower doses (i.e. doses below 100 mg daily) of cabozantinib in mCRPC with visceral involvement.
* To collect blood, urine, tissue, and plasma which may be used determine if there are germline genetic variations that correlate with toxicity.
* To pilot correlations between molecular content between circulating tumor cells (CTCs), large oncosomes, and tumor tissue.

Eligibility Criteria:
KEY INCLUSION CRITERIA

- mCRPC that includes visceral disease. Visceral metastatic disease is defined as solid organ infiltration that is not bone or lymph node metastases.

KEY EXCLUSION CRITERIA

* Recent history (\<6 months) of gastrointestinal hemorrhage requiring blood transfusion.
* Tumor involvement in the intestinal lining which the treating physician deems at risk for perforation with rapid tumor response.
Neutrophil-lymphocyte Ratio and Platelet-lymphocyte Ratio as Predictors for Adverse Events in EVAR

This study investigated the association of chronic inflammatory markers with the clinical outcome after endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm.

The study included 230 consecutive AAA patients, treated electively by EVAR from March 2016 to February 2019. The values of simple inflammatory markers,neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR), were measured pre- and postoperatively.Adverse events included any major adverse cardiovascular events (MACE), acute kidney injury and death from any cause.

Eligibility Criteria:
Inclusion Criteria:

* AAA
* Elective
* EVAR

Exclusion Criteria:

* Emergency
* Open surgery