cyrilzakka/clinical-trials huggingface dataset:
The Clinical Course and Factors for the Progression of Uninvestigated Dyspepsia to Functional Dyspepsia

Dyspepsia is one of the most common gastrointestinal diseases. This disease was defined as predominant epigastric pain lasting for at least 1 month, which can be accompanied with other symptoms, such as epigastric fullness, and early satiety. Despite dyspepsia symptoms lasting for ≥1 month represented clinical problem, a longer duration of 6 months or more after first-onset symptom was required for the diagnosis of functional dyspepsia based on ROME IV criteria. It was unclear about the natural procession of first-onset dyspepsia to functional dyspepsia assessed by Rome IV or Asia criteria and possible factors associated with this progression.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years old who had first-onset dyspepsia with one or more symptoms of epigastric pain, epigastric burning, postprandial fullness, early satiation and that has lasted for more than 1 month to 3 months.

Exclusion Criteria:

1. Patients with local or systemic diseases which may cause dyspeptic symptoms:

   Known active peptic ulcer, cholecystitis, gallstone, gastrointestinal obstruction, gastroparesis, and etc.
2. Known acute or chronic injury of liver or kidney
3. Obvious hematological abnormality, or endocrine and metabolic diseases
4. Known malignancy; Obvious cardiovascular or cerebrovascular diseases (such as coronary heart disease, arrhythmia, cerebral infarction and etc.
5. Other conditions which may be associated with dyspeptic symptoms (such as NSAIDs associated dyspepsia)
6. organ failure defined by Marshall standard or severe psychiatric illnesses
7. pregnancy or lactation
8. unable to provide consent
Ultrasound Imaging of Neck Blood Vessels in Pregnant and Non-Pregnant Women

There is no data regarding success rates and incidence of carotid punctures during central venous cannulation (CVC) in the pregnant patients. We hypothesize that because of the anatomical and physiological changes associated with pregnancy, these patients are at higher risk of procedure failure and carotid puncture than the general population. The purpose of our study is to determine the success rate and incidence of carotid punctures using an ultrasound-simulated procedure in pregnant and non-pregnant patients.

There is no data regarding success rates and incidence of carotid punctures during central venous cannulation (CVC) in pregnant patients. We hypothesize that because of the anatomical and physiological changes associated with pregnancy, these patients are at higher risk of procedure failure and carotid puncture than the general population. The purpose of our study is to determine the success rate and incidence of carotid punctures using an ultrasound-simulated procedure in pregnant and non-pregnant patients.

Pregnant patients and adult female volunteers (controls) were recruited. Subjects were placed supine with wedge under the right hip, and head turned 35 degrees to the left. Two different approaches for CVC, the central landmark and the palpatory approach were used. The ease of identification of the landmarks was noted. CVC was simulated using an ultrasound probe, on pre-marked points. Ultrasound images were obtained, within the same parasagittal plane, directed 30 degrees caudad, in a manner simulating how a syringe and needle would be placed for central venous cannulation. The investigator placing the probe was blinded to the image being generated. The vertical cursor of the ultrasound, which serves to delineate the path of a needle, was placed in the image. If the cursor intersects the vein, the attempt is considered successful. If the first attempt is not successful, the investigator placing the probe was asked to redirect the probe to the second and if necessary to the third marked point. This was done for each approach. If the cursor intersects the carotid artery, the attempt is considered an accident and no further attempts were made. In addition to determining the success rate and the incidence of carotid punctures, the relative position of vein and artery was studied in each patient. For each approach, the best image was recorded, and three experienced anesthesiologist scored the images for vein and artery degree of overlapping.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients
* Healthy non-pregnant female volunteers

Exclusion Criteria:

* Urgent, emergent or hemodynamically unstable patients
* Patients with known abnormal neck anatomy, previous surgery or trauma involving the neck, or prior cannulation of neck vessels
An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)

The purpose of this study was to assess the long-term safety and efficacy of ABBV-8E12 (tilavonemab) in participants with progressive supranuclear palsy (PSP).

This study (M15-563) was a Phase 2, randomized, double-blind, multiple-dose, multicenter, long-term extension of NCT 02985879 (Study M15-562) in participants with progressive supranuclear palsy (PSP). Those who completed the 52-week Treatment Period in Study M15-562 and met all entry criteria were eligible for enrollment into this study. This study planned for a Treatment Period of up to 5 years and a post-treatment follow-up visit approximately 20 weeks after the last dose of study drug (including participants who prematurely discontinued treatment). All participants received ABBV-8E12 as follows: those who received placebo in Study M15-562 were randomized, in a 1:1 ratio, to either 2000 or 4000 mg; those who received ABBV-8E12 at a dose of either 2000 or 4000 mg in Study M15-562 continued on the same dose in this study.

This study was prematurely discontinued because the program for progressive supranuclear palsy was discontinued due to lack of efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Participant completed the 52-week treatment period in Study M15-562 (NCT02985879)
* In the opinion of the investigator, the participant was compliant during participation in Study M15-562 (NCT02985879)
* Participant has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend)

Exclusion Criteria:

* Participants who weigh less than 44 kg (97 lbs) at the time of study entry
* Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI)
* Participant has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results
* More than 8 weeks have elapsed since the participant received his/her last dose of study drug in Study M15-562 (NCT02985879)
* Participant is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the participant is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations
Lower Extremity Fixation In Neuropathic Patients Study

Prospective, multi-site, multi-year post-market clinical follow-up study on neuropathic patients treated/implanted with SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di Plating System, VALOR™ NAIL, HOFFMANN® LRF SYSTEM and/or T2® ICF SYSTEM of 200 patients with up to 10 sites

The selected design is a US, multi-center, multi-year, non-randomized, prospective observational study. The study subjects included are neuropathic patients treated/implanted with SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di Plating System, VALOR™ NAIL, HOFFMANN® LRF SYSTEM and/or T2® ICF SYSTEM of 200 patients with up to 10 sites.

Eligibility Criteria:
Inclusion Criteria:

* Subject is a male or non-pregnant female age 18 years or older at the time of surgery;
* Subject is willing and able to give written informed consent and comply with the requirements of this Clinical Investigation Plan (CIP); and
* Subject has neuropathy and is intended to be treated for deformity with the one or a combination of the below Systems in accordance with the legally cleared/ approved IFU and Surgical Technique Manual.
* HOFFMANN® LRF SYSTEM
* SALVATION™ EXTERNAL FIXATION SYSTEM
* SALVATION™ FUSION BOLTS AND BEAMS
* SALVATION™ 2 MIDFOOT NAIL
* SALVATION™ 3DI PLATING SYSTEM
* T2® ICF SYSTEM
* VALOR™ ANKLE FUSIO NAIL SYSTEM

Exclusion Criteria:

* Subjects determined, by the investigator, to be an inappropriate candidate for the procedure indicated;
* Unable to consent to participate (written, informed consent);
* Unable to attend/complete the requested follow-up visits
Could the Intraoperative Radiation Exposure (Fluoroscopy) of Percutaneous Pedicle Screw Fixation be Reduced Using an Electronic Conductivity Device?

To compare classical pedicle finder versus pedicle finder with impedancemetry on the perioperative radiation exposure of PPTLO. These two devices are already used in common practice.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between 18 and 80 years-old;
* Patient with an indication of PPTLO for one or two segments
* Patient in a position to understand protocol information;
* Patient who received information about the protocol and who did not show opposition to participate

Exclusion Criteria:

* History of posterior spinal fusion surgery on the spinal level concerned by the study;
* Morbid obesity (body mass index greater than 35 kg / m²);
* Major incapable (safeguard of justice, guardianship) and persons deprived of liberty.
* Simultaneous participation in another research protocol involving the human person
Yellow Fever Human Infection Model With YF-17D

No antiviral treatment exists for yellow fever, only supportive care, and therefore we rely on prevention through vaccination. Although this vaccine is very effective, stockpiles are insufficient in outbreak situations and some people have a contraindication to be vaccinated. For those who are unprotected and at risk of yellow fever infection, treatment could be life saving.

No antiviral treatment exists for yellow fever, only supportive care, and therefore we rely on prevention through vaccination. Although this vaccine is very effective, stockpiles are insufficient in outbreak situations and some people have a contraindication to be vaccinated. For those who are unprotected and at risk of yellow fever infection, treatment could be life saving.

Eligibility Criteria:
Inclusion Criteria:

* age 18-50 years

Exclusion Criteria:

* contraindication to receive YF-17D (immune deficiency, thymus illness)
* previous YF vaccination
* pregnancy
* chicken egg allergy
* hypersensitivity to any other substance in the YF-17D vaccine
* interval of \< 4 weeks of another live attenuated vaccine
Safety and Tolerability of Patisiran (ALN-TTR02) in Transthyretin (TTR) Amyloidosis

This was a multiple dose, dose escalation study designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of patisiran (ALN-TTR02) in participants with transthyretin (TTR) mediated amyloidosis (ATTR).


Eligibility Criteria:
Inclusion Criteria:

* Body mass index must be between 17 kg/m\^2 and ≤ 33 kg/m\^2;
* Women of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must use appropriate contraception;
* Males agree to use appropriate contraception;
* Diagnosis of TTR amyloidosis;
* Adequate blood counts, liver and renal function;
* Willing to give written informed consent and are willing to comply with the study requirements.

Exclusion Criteria:

* Known human immunodeficiency virus (HIV) positive status or known or suspected systemic bacterial, viral, parasitic, or fungal infection;
* Received an investigational agent, other than tafamidis or diflunisal, within 30 days prior to first dose study drug administration;
* Prior liver transplant;
* Poor cardiac function;
* Considered unfit for the study by the Principal Investigator;
* Employee or family member of the sponsor or the clinical study site personnel.
Late Respiratory Consequences of SARS-CoV-2 Pneumonia

The goal of this observational study is to learn about the respiratory system in post-COVID syndrome. The main question aims to answer:

how the post-COVID syndrome alters the lung function Participants will be asked to perform lung function tests. Researchers will compare post-COVID group to matched control healthy individuals.


Eligibility Criteria:
Inclusion Criteria: COVID-19 infections in the post-COVID group. -

Exclusion Criteria:

-
Clinical Effectiveness of In-office Bleaching Activated With a LED/Laser Device

There is a controversy in the dentistry literature about how the use of associated light to activate 35% hydrogen peroxide gel during in-office tooth bleaching may increase the bleaching effectiveness. The studies that demonstrated an increased level of bleaching using light activation employed lower hydrogen peroxide gels while the ones reporting no statistical difference employed higher hydrogen peroxide gels.

The hypothesis of this study is that the effectiveness of light activation tooth bleaching in dependent on the hydrogen peroxide concentration employed.

The aim of this study is to compare the color change and tooth sensitivity of in-office bleaching using different hydrogen peroxide concentrations and with or without light activation. Sixty patients will be enrolled in this trial and divide equally into 4 groups according to the combination of the main factors hydrogen peroxide concentration (35% or 20%) or LED/laser activation (yes or no). Three 15-min applications will be performed in each clinical appointment. A LED/laser device will be used in the respective groups for three 1-min application with an interval of 2 min. The same procedure will be repeated one week later. The color change will be assessed after hte 1st and 2nd session, after 1 week and 6 months of the end of the treatment using a value-oriented shade Vita Classical and a spectrophotometer Easy Shade. The tooth sensitivity will be reported by patients using a 0 to 10 visual analog scale. The Student t test (α = .05) will be used to compare the tooth color changes and the intensity of tooth sensitivity between groups at baseline and immediately after the first and second bleaching appointments. The Fisher exact test and Student t test (α = .05), respectively, will be used to analyze the percentage of patients with tooth sensitivity and its intensity.

Eligibility Criteria:
Inclusion Criteria:

* Participants should be at least 18 years old;
* Participants should have good general and oral health
* Participants should have six caries-free maxillary anterior teeth without restorations on the labial surfaces
* Participants should be willing to sign a consent form
* Participants should have central incisors darker than shade C2.

Exclusion Criteria:

* Participants that had undergone tooth-whitening procedures
* Participants that had labial anterior restorations, were pregnant or lactating.
* Participants with severe internal tooth discoloration (such as tetracycline stains, fluorosis, pulpless teeth).
* Participants with bruxism habits or any gross pathology in the mouth
Early Detection of Lung Cancer in a High-Risk Population Defined by PFT, Biomarkers, and CT Scanning

Lung cancer is the number one cancer killer in Kentucky and has a very high incidence within the 5th Congressional District of Kentucky (110.8 cases per 100,000 in period 1996-2000). Surgical removal provides the best chance for cure. Unfortunately, the majority of lung cancer cases are detected in an advanced stage, when surgical resection is impossible. This leads to shorter survival rates and increased mortality rates for lung cancer, increased patient suffering, and greater cost to the healthcare system. Methods that favor earlier detection are therefore crucial for successful treatment. One such method, low-dose spiral computed tomography (CT) is being studied to determine whether its use as a screening method will lead to earlier detection and earlier intervention, perhaps impacting survival and mortality in lung cancer. This method has a modest sensitivity to detect lung cancer, but low specificity, which leads to many false positives and a low negative predictive value. The present study is designed to address both of these limitations by: 1) identifying individuals in the population at highest risk for developing lung cancer (due to smoking habits and decreased pulmonary function) for subsequent CT screening, and 2) performing biomarker testing in conjunction with the CT scan to improve the ability to discern individuals with benign lung nodules from those with malignant tumors. The 5th Congressional District of Kentucky has one of the highest rates of lung cancer in the nation and is an ideal location to test the validity (sensitivity and specificity), feasibility (negative and positive predictive value), and efficacy (stage distribution shift to earlier stage disease, increased survival, and decreased cancer-specific mortality) of these strategies to enhance early detection.


Eligibility Criteria:
Inclusion Criteria:

* Age 55-75 years old.
* Identification of a primary care physician (can be identified by study staff if needed).
* FEV1/FVC \<70% (GOLD 1 or higher COPD) (poor breathing function).
* \> or = 40 pack-year current or former (within the last 10 years) tobacco use (i.e. heavy cigarette smoking history).

Exclusion Criteria:

* Enrolled in any other lung screening or lung cancer prevention trial.
* Chest CT within the prior 12 months.
* Inability to lie flat with arms raised above the head.
* Current or prior personal history of lung cancer.
* Prior history of cancer within the last five years or currently receiving treatment for cancer, except adequately treated non-melanomatous skin cancer or in-situ cervical cancer.
* Life expectancy of less than 5 years.
* Patients requiring supplemental oxygen.
* Inability to give informed consent.
Trial of Herb Yuyang Ointment to Diabetic Foot Ulcer

The purpose of this study is to determine if dressing change with a kind of herb Yuyang ointment is clinically more efficacious and safer than Conventional treatment in the treatment of diabetic foot ulcers.

1. Developing a Document Retrieval strategy for clinical trials of Chinese medicine treatment of diabetic foot ulcer according to the research program(finished)
2. Selecting and Evaluating the above trials,developing a methodological quality evaluation criteria(finished)
3. extract information, verification, meta-analysis, sensitivity analysis and sub-group analysis(finished)
4. comprehensive evaluating the pros and cons evidences of traditional Chinese medicine, acupuncture and Chinese and Western combined medicine with the treatment of diabetic foot of (finished)
5. we find dress change with a certain kind of herb ointment is very effective and safe to diabetic foot ulcers.The following step is randomized controlled multicenter clinical trial to verify it's efficacy and safety

Eligibility Criteria:
Inclusion Criteria:

* In-patient or out-patient patients diagnosed with diabetic foot ulcers
* Gangrene or ulceration occurred more than 3 weeks
* Over 18 years of age
* Gender-open
* The type of diabetes (type 1 or type 2) open
* Patients receive a written informed consent to participate in the trial

Exclusion Criteria:

* Serious complications of heart, liver, lung, kidney damage
* Malignant tumors
* Allergy for Chinese medicine used
* Pregnant women and breast-feeding women
Effect of Pasta on Blood Glucose Response in Normal Subjects

The objective of this study is to determine whether ingestion of modified pasta products (Dreamfields, Miracle Noodles) result in an improvement in blood glucose concentration when compared with a traditional pasta.

On one occasion the pasta will be a traditionally available pasta; on another occasion, approximately 1 week later a modified pasta, advertised to contain \~ 5 grams of digestible carbohydrate, or to be low in digestible starch, will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Normal blood glucose concentration
Electronic Pre-exposure Prophylaxis (PrEP) Initiation and Maintenance Home Care System

The premise for the study is that a tailored approach for rural young men who have sex with men (YMSM), addressing known barriers of transportation, access to providers, and privacy, is most likely to yield high levels of Pre-exposure Prophylaxis (PrEP) initiation and persistence in care.

The premise for the study is that a tailored approach for YMSM from rural and small town areas, addressing known barriers of transportation, access to providers, and privacy, is most likely to yield high levels of PrEP initiation and persistence in care. The study sites are Alabama, Georgia, North Carolina, and Mississippi.

Using a smartphone application (app), participants assigned to the intervention will receive and maintain a PrEP prescription without needing to leave their home (excepting pharmacy pick-up in some cases) - achieved through app-based surveys/screenings, telemedicine consultations, and home specimen self-collection.

Eligibility Criteria:
Inclusion Criteria:

* Assigned male at birth
* Age 18-29 (inclusive)
* Live in a study state (Georgia, Mississippi, North Carolina, Alabama)
* Able to provide informed consent and complete survey instruments in English
* Willing to provide complete contact information (including 2 alternate contacts)
* Able and willing to provide identification verification for viewing confirmation only
* Laboratory confirmed HIV negative
* Owns a smartphone capable of running the study app
* Male sex partners in past 6 months or clinician discretion of epidemiologic context of HIV risk
* Behavioral/epidemiological indication for PrEP :

  * History of inconsistent or no condom use with more than one partner
  * History of inconsistent or no condom use with one partner who is not mutually monogamous
  * HIV-positive sexual partner
  * Any sexually transmitted infection (STI) diagnosed in past 6 months
  * Commercial sex work
  * African American MSM reporting anal sex in the past 6 months
  * Clinician discretion based on epidemiologic context of HIV risk
* Willing to take FDA-approved daily oral PrEP
* Willing to use study-provided PrEP navigation services
* Willing to self-collect specimens

Exclusion Criteria:

* HIV positive (self-report or laboratory confirmed)
* Chronic Hepatitis B or no verification of hepatitis B vaccination
* Currently enrolled in any HIV prevention trial (biomedical)
* Currently taking oral PrEP based on self-report
* Creatinine clearance \<60 ml/min based on the Cockcroft-Gault equation
* Symptoms of acute HIV infection within the prior 30 days
* Contraindications to oral PrEP
* Personal diagnosis or family history of hemophilia
* Health insurance with Kaiser Permanente (unable to prescribe PrEP through the study)
* Investigator discretion to exclude anyone whose best interest is not to participate
* Evidence of fraudulent participation, such as duplicate Internet Protocol (IP) address, multiple screening attempts, duplicate emails, etc