cyrilzakka/clinical-trials huggingface dataset:
Laparoscopic Total vs Partial Fundoplication in Patients With Atypical Symptoms of Gastroesophageal Reflux Disease

One hundred and twenty patients with documented extraesophageal symptoms of gastroesophageal reflux disease were randomized to either undergo floppy Nissen (n= 60) or Toupet fundoplication (n= 60). Symptom scores of extraesophageal symotoms and quality of life were prospectively evaluated. Analysis of the treatment results showed a significant improvement of symptoms in both patient groups.Quality of life improved substantially at short- and long-term follow up in both groups and there were no statistical differences between the groups in this parameter.


Eligibility Criteria:
Inclusion Criteria:

* extraesophageal symptoms of gastroesophageal reflux disease
* undergoing surgery for gastroesophageal reflux disease
* at least 18 years old

Exclusion Criteria:

* patients under the age of 18 years
* previous anti-reflux surgery, other surgical procedures in the vicinity of the gastroesophageal junction
* major psychiatric illness
* unstable chronic illnesses (such as diabetes)
* inability of the patient to complete the survey.
Multiple Attacks Study to Compare the Efficacy and Safety of MK-0974 With Placebo for Acute Migraine (MK-0974-031)

The purpose of the study is to assess the safety and efficacy of telcagepant (MK-0974) in acute treatment of multiple migraine attacks with or without aura. Primary hypotheses of this study are that telcagepant is superior to placebo, as measured by the proportion of participants who have pain freedom, pain relief, pain freedom consistency, pain relief consistency, and absence of photophobia, phonophobia, and nausea at 2 hours post-dose.


Eligibility Criteria:
Inclusion Criteria:

* History of migraines within the past year
* 1 to 8 moderate or severe migraine attacks per month in the past 2 months that lasted between 4 to 72 hours if untreated
* Use acceptable contraception throughout the study
* Able to complete the study questionnaire(s) and paper diary
* Limit consumption of grapefruit juice to no more than one 8 ounce glass a day

Exclusion Criteria:

* Pregnant or breast-feeding or is expecting to become pregnant during the study
* Difficulty distinguishing his/her migraine attacks from tension or interval headaches
* A history of mostly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours
* More than 15 headache-days per month or has taken medication for acute headache on more than 10 days a month in the past 3 months
* Greater than 50 years old at the age of migraine onset
* Previously taken telcagepant
A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation

This study evaluates whether the Potlako+ intervention of community education, clinical provider support, and patient navigation can improve access to cancer case for patients presenting with symptoms of cancer. Half of communities will receive the Potlako+ intervention, while the other communities will continue to receive standard programs.

The Potlako+ trial is a pair-matched, community-randomized study involving 20 rural and peri-urban communities in Botswana (population \~190,100 with \~100,000 30 years or older). Communities will be randomized 1:1 to the Potlako+ intervention versus standard care. The goal of the intervention is to identify individuals with symptoms/signs suggestive of cancer and expedite diagnosis (and treatment).

The trial includes a community education component focused on cancer awareness and importance of early diagnosis and a patient navigation component that aims to expedite the diagnostic evaluation. Community education will be directed at approximately 50,000 community residents (30 years and older). We anticipate approximately 1500 cancer suspects will be identified by their clinic providers.

Eligibility Criteria:
1. Community members

   1. Inclusion Criteria:

      * Botswana citizen
      * Age 30 years or older
      * engaged in longitudinal care for chronic health problem
      * resident of study community
   2. Exclusion Criteria:

      * Involuntary incarceration
      * Educational messaging could interfere with clinical management or increase distress in the opinion or clinic or research staff
2. Cancer suspects

   1. Inclusion Criteria:

      * Botswana citizen
      * Age 30 years or older
      * resident of study community
      * Recorded as a cancer suspect by clinic staff
   2. Exclusion Criteria

      * Involuntary incarceration
      * Unable or unwilling to provide confirmation of informed consent
      * Already engaged in oncology care
Retinal Vascular Manifestations in Patients With Common Internal Diseases on OCTA Tomography Angiography

Hypertension, diabetes mellitus, and dyslipidemia are common internal diseases, and all diseases are atherosclerosis risk factors. Previous studies applied color fundus photography to analyze retinal vascular changes (including exudation, hemorrhage, neovascularization, etc.) in patients with hypertension or diabetes, but the examination results could not be quantified.

This study intends to apply optical coherence tomography angiography (OCTA) to examine retinal vessels. This method has the following advantages: 1) It can quantify vascular changes, and 2) It is noninvasive and reproducible for patients' follow-up.

This study was designed to investigate retinal vascular changes in patients with hypertension, diabetes, and dyslipidemia on OCTA. We will collect the patients' general information (gender, age), comorbidities, medications, blood lipids, blood glucose, carotid ultrasound, ankle-brachial index, ambulatory blood pressure monitoring, color fundus photography, and OCTA results. We will follow up with the patients for five years and conduct the mentioned examinations once a year. We will also investigate the correlation between systemic atherosclerosis (such as coronary artery stenosis, and carotid artery stenosis) and retinal vasculopathy in patients with these diseases.

Patients with hypertension, diabetes mellitus, or dyslipidemia, who go to the department of geriatric medicine, Beijing Tongren Hospital from March 2022 to December 2023 will be included. We will collect general information, comorbidities, medication, laboratory tests, and examination results. These patients will be followed up for 5 years with a yearly collection of comorbidities, medication, laboratory tests, and examination results.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hypertension
* Or patients with diabetes
* Or patients with dyslipidemia
* Agree to participate in this study

Exclusion Criteria:

* Patients with malignant tumors
* Patients with autoimmune diseases
* Patients with immunodeficiency disease
* Disagree to participate in this study
Replication of the Teen Outreach Program in the Pacific Northwest

The Northwest Coalition for Adolescent Health (NWCAH) replicated the Teen Outreach Program (TOP) in five states across the pacific northwest including Idaho, Alaska, Montana, Oregon, and Washington. The purpose of this study is to measure: at the end of the program year, were TOP students less likely than control group students to report ever being pregnant or causing someone to be pregnant?


Eligibility Criteria:
Inclusion Criteria:

* Has parental consent and student assent
* Attends one of the schools and/or classes chosen for the program

Exclusion Criteria:

* Lack of consent or assent
Registry of Malignant Arrhythmias and Sudden Cardiac Death - Influence of Diagnostics and Interventions

The "Registry of Malignant Arrhythmias and Sudden Cardiac Death - Influence of Diagnostics and Interventions (RACE-IT)" represents a mono-centric registry of patients being hospitalized suffering from malignant arrythmias (ventricular tachycardia or fibrillation) and sudden cardiac death (SCD).

Detailed findings of patients' clinical outcome regarding mortality and co-morbidities related to the presence of invasive diagnostics or therapies including coronary angiography, percutaneous coronary intervention (PCI), electrophysiological testing (EP), catheter ablation and implanted cardiac devices (e.g. implantable cardioverter-defibrillators) will be documented. Patients will be included when being hospitalized from the year 2004 until today.


Eligibility Criteria:
Inclusion Criteria:

Hospitalization due to:

* ventricular tachycardia
* ventricular fibrillation
* sudden cardiac death

Exclusion Criteria:

* not diagnosed with one or more of the above
Vitamin D and HIV-Cardiovascular Disease in Children and Young Adults

The relationship of Vitamin D levels in children and young adults to atherosclerosis.


Eligibility Criteria:
Inclusion Criteria - Documentation of HIV Infection Between ages of 8 and 25

* On stable ART for at least 12 weeks for the HIV+ patients
* Cumulative duration of ART for at least 48 weeks for HIV + patients
* Healthy child/young adult with age and race matched to HIV+ patient for the HIV- controls
* Absence of HIV based on medical and medication history

Exclusion Criteria:

* Taking \> 800 IU of Vitamin D per day
* Parathyroid or Calcium disorders
* Acute illness and active inflammatory condition
* Chronic illnesses that include malignancy, diabetes, CAD
* Pregnancy and lactation
* Creatinine Clearance \<50 ml/min
* Hgb \< 9.0 g/dL
* AST and ALT \> 2.5 upper limits of normal
Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX) - Atrium Health

To demonstrate the safety, efficacy, and feasibility of short-course post-operative antibiotic treatment for simple and complicated appendicitis

This is a single center, randomized controlled trial to determine if decreasing the amount of antibiotics after appendicitis surgery can decrease the risk of adverse effects associated with antibiotics while at the same time ensuring participant safety.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Planned appendectomy (laparoscopic or open)
* Willing and able to provide informed consent
* Working telephone number or reliable method to contact patient after hospital discharge

Exclusion Criteria:

* Unable to consent
* Pregnant Women
* Prisoners
* immunocompromised as determined by clinical team, or patients actively receiving steroids, chemotherapy, or immunosuppressing medications (for example tacrolimus), or patients with active hematologic malignancy affecting the immune system, leukopenia, or end-stage Acquired immunodeficiency syndrome (AIDS)
* Heart Failure
* Allergy to Bupivacaine
* Unlikely to comply with treatment or follow-up
* Inpatient consultation for appendicitis
* Clinically suspected sepsis based on Sepsis-3 definition
* Current use of antibiotics for other indications
* Type 1 Diabetes or uncontrolled hyperglycemia
MIRACLE Study: A Study of Once-Monthly Intravenous Mircera in Hemodialysis Participants With Chronic Renal Anemia

This single-arm study will assess the long-term maintenance of hemoglobin levels, safety, and tolerability of once-monthly intravenous administration of Mircera in hemodialysis participants with chronic renal anemia. Those currently receiving darbepoetin alfa, epoetin alfa, or epoetin beta maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200, or 360 micrograms (mcg) per month (based on the erythropoiesis stimulating agent \[ESA\] dose administered on Week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the country-specific target range (11 to 13 grams per deciliter \[g/dL\] for Switzerland and 10 to 12 g/dL for Austria).


Eligibility Criteria:
Inclusion Criteria:

* Adults greater than or equal to (≥) 18 years of age
* Chronic renal anemia
* Hemoglobin concentration in country-specific target range (Switzerland: 11 to 13 g/dL; Austria: 10 to 12 g/dL)
* Regular long-term hemodialysis therapy with the same mode of dialysis for ≥3 months
* Continuous intravenous or subcutaneous maintenance ESA treatment during previous 2 months

Exclusion Criteria:

* Transfusion of red blood cells during previous 2 months
* Significant acute or chronic bleeding, such as overt gastrointestinal bleeding
* Active malignant disease (except non-melanoma skin cancer)
Validity of Neck Extensor Muscles Endurance Test in Non-specific Chronic Neck Pain and Asymptomatic Subjects

Neck pain (NP) is one of the most common and costly musculoskeletal complaints in today's societies. Cervical muscles endurance has been commonly associated with the development of NP. Real-time ultrasound imaging is a reliable and valid technique recently used by physical therapists to evaluate muscle structure, function and activation patterns. The aim of this study is if change in muscle thickness can correlate with the results of the endurance testing.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with neck pain: experiencing pain for at least 3 months in the last year, having pain score of 3 or more on visual analogue scale.
* Healthy subjects: no history of neck pain

Exclusion Criteria:

* History of cervical discopathy
* Any surgery on neck
* Traumatic neck injury
* Any congenital disorders
South Korean Pitavastatin Heart Failure Study

We want to evaluate the utility of statins on heart function according to potency. Patients with chronic ischemic heart failure are administered pitavastatin 4mg or pravastatin 10mg for 52 weeks. Then we evaluate the effect of pitavastatin and pravastatin primarily on rate of hospitalization for cardiovascular cause and lipid profile secondarily biomarker, echocardiography parameter, 6-minute walk, change of NYHA class distribution, cardiovascular mortality.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who accepted to enter the study by written informed consent
2. Age ≥ 30 years
3. LDL-cholesterol ≥ 70mg/dl
4. Chronic heart failure of :

   * NYHA class II \~ III
   * Ischemic etiology
   * Left ventricular ejection fraction \< 45%
   * Optimal therapy for chronic heart failure and stable clinical condition over the two weeks.

Exclusion Criteria:

1. Patients who participated in other studies 3 months before enrollment
2. Statin treatment within 2 months before enrollment
3. Unstable decompensated heart failure at enrollment
4. Acute coronary syndrome or cerebral vascular disease within 3 months before enrollment
5. Coronary revascularization within 3 months before enrollment or planned at enrollment
6. Any other serious disease or condition which might effect life expectancy such as malignancy, life-threatening infectious disease.
7. Serum creatinine levels \>= 3.0 mg/dl
8. AST or AST levels \>=2.5 times of ULN
9. CK levels \>=2 times of ULN
10. Uncontrolled hypothyroidism : TSH level \>= 2 times of ULN
11. Pregnant or breastfeeding women, women who want to bearing
12. Patients who might to be unsuitable by the decision of investigators
Rectus Sheath Block in Cardiac Surgery

This is a prospective, randomized study. The purpose of this study is to evaluate the effect of post-surgical pain control of a type of peripheral nerve block, Rectus Sheath Block.

1. Does the rectus sheath block decrease opioid consumption postoperatively after cardiac surgery?
2. Does the rectus sheath block decrease VAS pain scores postoperatively after cardiac surgery? Study participants will be assigned to receive either rectus sheath block or no block.


Eligibility Criteria:
Inclusion Criteria:

* In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Adults 18-85 years old
  2. Scheduled to undergo cardiac procedures involving chest tubes
  3. Male or female

Exclusion Criteria:

* An individual who meets any of the following criteria will be excluded from participation in this study:

  1. ASA class V
  2. Urgent or emergent surgery
  3. Contraindications to administration of local anesthesia (e.g. local anesthetic allergy)
  4. History of substance abuse or chronic opioid use
  5. Patient refusal or inability to consent
Comparing Clinical Efficacy of One-Week Dual Delayed-Release Dexlansoprazole and Esomeprazole for GERD Grade A and B

Rapid onset of proton-pump inhibitors to achieve a fast symptom is an unmet need in treating gastroesophageal reflux disease (GERD) but there was no report on the short-term clinical effects and timing to symptom relief comparing dexlansoprazole 60 mg to esomeprazole 40 mg. This pilot study aims to compare the one-week clinical effects of single doses of the two drugs in treating GERD patients.

A comparative study to different PPIs in pharmacokinetic change showing that after 12-24 hours post dose, mean percentage of time with pH \> 4 and average of mean pH were greater for dexlansoprazole than esomeprazole . However, the study did not report the clinical effect after tablets used. There was no report on the short-term clinical effects and timing to symptom relief of gastroesophageal reflux disease (GERD) between dexlansoprazole 60 mg and esomeprazole 40 mg. Therefore, we conducted a randomized controlled, open-label, study to compare the 7-day clinical effects of single doses of dexlansoprazole 60 mg and esomeprazole 40 mg in for GERD.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach, who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy were recruited

Exclusion Criteria:

* taking antisecretory agents, such as PPIs and histamine-2 receptor antagonists within 2 week prior to the endoscopy
* coexistence of peptic ulcer or gastrointestinal malignancies
* pregnancy
* coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia),
* previous gastric surgery
* allergy to dexlansoprazole or esomeprazole
* symptom score of a validated questionnaire (Chinese GERDQ) less than 12
CMPA-GO Study: Growth and Safety Outcomes in Infants With CMPA Fed a Novel Extensively Hydrolyzed Formula

CMPA-GO Study: Growth and safety Outcomes in infants with CMPA fed a novel extensively hydrolyzed formula


Eligibility Criteria:
Inclusion Criteria:

1. Full term infant (gestational age ≥37 weeks and ≤42 weeks).
2. Birth weight ≥2500 g and ≤4500 g.
3. Infant aged ≥29 days (\>4 weeks) and \<5 months (≤22 weeks).
4. Not breastfed at time of Screening Visit.
5. History of an immediate-type (IgE-mediated) allergic reaction to a cow's milk-containing food or at least 2 persistent severe symptoms suggestive of delayed-onset (non-IgE-mediated) CMPA.

Exclusion Criteria:

1. Prior use of eHF, HRF or AAF for more than 2 weeks before randomization.
2. Demonstrated chronic malabsorption not due to CMPA.
3. History of anaphylaxis to CMP.
4. Participants with a history of confirmed Food Protein-induced Enterocolitis Syndrome (FPIES) or Heiner syndrome.
5. Any contraindication to the open OFC (eg. unstable respiratory disease), or any disorder in which epinephrine is contraindicated.
6. History of any immunotherapy for CMPA.
7. Past or current disease or disorder which, in the opinion of the Investigator or the sponsor either places the participant at risk because of participating in the study or may influence the results of the study, or the subject's ability to participate in the study.
Respiratory Muscle Strength and Exercise Capacity in Smokers

This cross-sectional study aims to evaluate the respiratory muscle strength and physical capacity of symptomatic adult smokers in Muğla. The study population will be the patients who were admitted to the pulmonary outpatient clinic of Muğla Training and Research Hospital between July 2024 and December 2024. The primary outcome is the proportion of individuals with Maximum Inspiratory Pressure (MIP) below 80%. Secondary outcomes include the 6-Minute Walk Test (6MWT) distance, Maximum Expiratory Pressure (MEP), and COPD Assessment Test (CAT) scores. Smokers will be categorized into COPD, PRISm, and Pre-COPD groups. The study will adjust for BMI as a key confounder and assess the modifying effects of gender, smoking habits, and age. Ethical approval and informed consent will be obtained, with data analysis focusing on descriptive statistics, comparative analysis, and regression models to understand the impact of smoking on respiratory health.


Eligibility Criteria:
Inclusion Criteria:

* At least 5 packages of cigarette smokers who have an appropriate PFT done at our lab. (pulmonary function test must be performed at evaluable standards according to ERS/ATS guidelines)

Exclusion Criteria:

* Respiratory infection at the time of measurement (upper or lower resp. tract, viral or bacterial infections)
* Presence of chronic respiratory diseases (Asthma, IPF, Bronchiectasis, \[except COPD\])
* Exacerbation due to chronic respiratory diseases (except mild COPD exacerbation)
* Neuromuscular disease (ALS, Guillain-Bare syndrome, Muscular dystrophies, Myasthenia gravis)
* Restrictive pulmonary disease (IPF, Sarcoidozis, Progresif Pulmonary Fibrosis)
In Vivo Clinical Investigation of the Safety and Performance of Dental Implants TBR® Bone Level

Partial or total edentulousness has a significant impact on quality of life both functionally and aesthetically.

TBR® Bone Level Implants allow the patient to prevent bone resorption and maintain facial tissue and musculature support. At the functional level, the patient who benefits from implant treatment regains normal masticatory function with all the benefits on the quality of life that this can bring him.

Due to the osseointegration of the implant and the biocompatibility of the materials used, the implant treatment remains effective in the long term and makes it possible to maintain the aesthetics of the smile.

Many adults have one or more missing teeth. The negative consequences of partial or total edentulousness are numerous in the orofacial sphere:

* Edentulousness causes a strong aesthetic deficit due to the lack of support of facial tissues and musculature;
* Edentulousness generates a functional deficit that can have significant repercussions on the nutritional status of the affected subject;
* Edentulousness is accompanied by bone resorption of the jawbones which is inevitable in the absence of implant treatment;
* In addition, the resulting feelings of discomfort and fragility are experienced as a real psychological handicap by the patient, partially or totally edentulous, which can then have significant repercussions on his social life.

TBR® Bone Level implants are intended for placement in the maxillary or mandibular arch in partially or completely edentulous patients for prosthetic restoration in the following cases:

* Single edentulousness,
* Intercalary edentulousness,
* Terminal edentulousness,
* Total edentulousness.

The following clinical conditions must be observed before placing a dental implant:

* Sufficient quality and volume of bone support;
* Healthy oral condition;
* no contraindications for implant setting

The expected benefits of this surgery are to improve the quality of life of patients, to recover the chewing function and the aesthetics of the smile.

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age or older
* Patient who has completed bone growth
* Patient informed and willing to participate in the study
* Partially or totally toothless patient who will be implanted with the TBR® Bone Level implant(s) for the prospective cohort
* Patient implanted with the TBR® Bone Level implant(s) before June 2011 for the retrospective cohort

Exclusion Criteria:

* Pregnant or lactating women
* Patient with bone disease of the head and neck region
* Patient refusing to participate in the study
* Patient with at least one contraindication to implantation
* Patient on osteoporosis treatment with Biphosphonates or Denosumab.