cyrilzakka/clinical-trials huggingface dataset:
Comparison of Plus Lens Addition Versus Vision Therapy for Management of Accommodative Infacility

This Randomized Control Trials Study , conducted in Lahore, Pakistan, investigates the comparative efficacy of two approaches-plus lens addition of +0.75 diopters (D) and vision therapy using the HART chart-for managing accommodative infacility. Accommodative infacility, a condition characterized by the eye's reduced ability to adjust focus between distant and near objects, impacts both visual comfort and performance, particularly during prolonged near work.

The study sample comprises 38 participants, aged 15 to 35 years, divided into two groups: one group receiving plus lens addition of +0.75 D and the other undergoing structured vision therapy with the HART chart. Findings revealed that vision therapy was significantly more effective than plus lens addition, with results showing statistical significance at P \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 15 to 35 years.
* Diagnosed with accommodative infacility.
* Capable of adhering to the full study duration of 6 weeks.
* Measurable accommodative dysfunction confirmed through baseline eye examinations.
* Written informed consent from participants or guardians.

Exclusion Criteria:

* Presence of other significant ocular or neurological conditions.
* Inability or unwillingness to adhere to the prescribed treatment.
* Prior treatment for accommodative infacility within the past 6 months.
* Significant uncorrected refractive errors.
* Medical contraindications for using plus lenses or vision therapy.
Endoscopist and Endoscope Motions During Colonoscopy

The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements during colonoscopy.

The increasing development of interventional digestive endoscopy raises the challenge to teach and learn complex endoscopic procedures. Nowadays experts are facing the challenge of explaining precisely an elaborate choreography of movements performed during the procedure, while novices are confronted with a broad range of hand, wrist and shoulder movements each resulting in different endoscope responses. The teaching strategy of endoscopy could benefit from a dedicated motion library that would associate the endoscopist's motion and the consequent endoscope response. A simplified endoscopic language made of individual motions could greatly shorten the learning curve.

The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements during colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Patient male or female
* Patient over 18 years old
* Patient who are scheduled for a colonoscopy procedure under sedation
* Patient able to understand the study and provide written informed consent
* Patient affiliated to the French social security system.

Exclusion Criteria:

* Patient unable to provide a written informed consent
* Patient with an altered colonic anatomy due to previous surgery
* Patient with a known anomaly of the colon
* Patient carrying an implantable medical device (pacemaker...)
* Patient with a condition preventing its participation to study procedures, according to investigator's judgment
* Pregnancy or breastfeeding
* Patient in custody
* Patient under guardianship
Interleukin 6-guided Antibiotic Prescriptions in AECOPD Inpatients

In this multicenter, prospective, randomized controlled study, we aimed to figure out, compared with the global chronic obstructive pulmonary disease initiative (GOLD) guideline -guided antibiotic therapy, whether Interleukin 6 (IL6)-guided antibiotic therapy for acute exacerbation of chronic obstructive pulmonary disease (AECOPD) can lead to a reduction in the use of antibiotics without increasing the rate of treatment failure.

Acute exacerbation is the first leading cause of hospitalization and mortality among patients with COPD. Infection of bacteria has been detected in 49.59% of patients with AECOPD. Antibiotic prescriptions for AECOPD patients are usually based on GOLD guideline. However, the newest study reported that more than 85% of AECOPD inpatients received antibiotic prescription in the United States, Europe and China. Not all patients will equally experience benefit from antibiotics. Interleukin 6 (IL6) was determined as a reliable clinical biomarker in guiding antimicrobial use. It remains unclear whether IL6-guided antibiotic therapy is safe and effective for hospitalized patients with AECOPD.

The study will recruit 440 AECOPD inpatients from at least six hospitals based in China. Eligible participants will be assigned to receive either IL6-guided antibiotic therapy or GOLD-guided antibiotic therapy in 1:1 ratio randomly. The hypothesis for this study is that IL-6 guided antibiotic therapy will reduce the rate of antibiotic prescriptions for AECOPD without increasing the rate of treatment failure, compared with the group treated with GOLD-guided antibiotic therapy.

Eligibility Criteria:
Inclusion Criteria:

1. AECOPD patients admitted to hospitals
2. The exacerbation has lasted for at least 24 hours but equal to or less than 21 days
3. ≥40 years of age but no more than 80 years old
4. With at least 10 pack-year history of smoking
5. Able to provide written informed consent and ensure the completion of the trial

Exclusion Criteria:

1. Axillary temperature≥38°C
2. Acute pneumonia identified by X-Ray or CT of the chest
3. Severe respiratory failure requiring admittance to ICU
4. Comorbidities require antibiotic therapy (i.e. infection at another site, systematic infection, active chronic inflammatory condition, specific viral infection)
5. Immunosuppression status (i.e., patients with HIV infection, with malignant tumor of blood system, receiving chemotherapy)
6. Concurrent diseases requiring corticosteroids (equivalent to 60mg prednisone/day or more than 30 days)
7. Antibiotic use in the previous four weeks
8. Current tracheotomy status
9. Bronchiectasis of origin other than COPD
10. Invasive mechanical ventilation
11. Patients diagnosed malignant tumors
12. Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception.
13. Newly diagnosed pulmonary embolism
14. Participation in another clinical trial
Outpatient Foley Catheter for Induction of Labor in Nulliparous for Prolonged Pregnancy

15 to 20 % of nulliparous needs an induction at term. None study has evaluated Foley catheter induction at home versus expectative in this population


Eligibility Criteria:
Inclusion Criteria:

* prolonged pregnancy (D+4) nulliparous no complication during pregnancy location near th hospital (20 mn by car) Bishop \< 6

Exclusion Criteria:

* medical history small for gestationnal age PROM Live alone
Vaccine Therapy of Prostate Cancer Patients With Recombinant Soluble Prostate-Specific Membrane Antigen (Rs-PSMA) Plus the Immunological Adjuvant Alhydrogel

The purpose of this research is to help us study a vaccine treatment for patients with prostate cancer. A vaccine is a medicine that teaches the body to destroy harmful infections and other diseases, such as cancer. Your immune system is made up of many different types of cells which fight infection and disease in your body. A vaccine may stimulate the immune system to destroy the cancer cells. It may also help to slow the growth of the cancer. The vaccine is a solution given as an injection into or under the skin. It is made up of several parts. The first part is PSMA, a protein present in many cancers, especially prostate cancer. It is referred to as rsPSMA when made in a laboratory for this study and is mixed with a material called Alhydrogel® (aluminum hydroxide suspension) which helps the immune system to make more cancer-fighting cells.


Eligibility Criteria:
Inclusion Criteria:

* Non-castrate metastatic patients must have biochemically progressive disease as defined by serial changes in PSA (with a serum testosterone \> or = to 180 ng/mL)following definitive primary therapy such as prostatectomy or radiation. Castrate metastatic patients must have biochemically progressive disease in the absence of radiographic evidence of disease progression with rising PSA values despite castrate (\<50 ng/mL) levels of testosterone following an adequate course of hormonal therapy. An adequate course of hormonal therapy is treatment with an LH-RH analog (with or without an anti-androgen) or orchiectomy.
* Prostate cancer must be histologically confirmed by the Department of Pathology at MSKCC.
* Karnofsky performance status \>70%.
* Patients must have adequate organ function as defined by:
* WBC \> or = to 3000/mm3, neutrophils \> or = to1000/mm3, platelet count \> or = to l00,000 mm3
* Bilirubin \<2.0 mg/dl
* Alkaline Phosphatase and SGOT \<3.0 times the upper limit of normal
* Creatinine \< or = to 2.0 mg/dl
* Hemoglobin \>9.0 g/dl
* ALT \<2.5 times the upper limit of normal
* Patients must be at least 18 years of age
* Expected survival must be \>6 months
* Patients must sign informed consent.
* Non-castrate metastatic patients must have a serum testosterone \>180 ng/mL.

Exclusion Criteria:

* Radiographic evidence of disease progression.
* Clinically significant cardiac disease (New York Heart Association Class III/IV or severe debilitating pulmonary disease).
* Active CNS or epidural tumor.
* An infection requiring antibiotic treatment.
* Lymphopenia defined by lymphocytes \<1000/mm3.
* Cancer related pain requiring the use of opioid containing analgesics.
* Positive stool guaiac, excluding hemorrhoids or documented radiation-induced proctitis.
* Concurrent treatment with nutritional or herbal supplements (e.g., PC SPES or similar agents) which could potentially confound the interpretation of study results.
* History of an active secondary malignancy except for non-melanoma skin cancer.
Cardiovascular Safety Research: Bupivacaine With Vasoconstrictor Versus Ropivacaine in Brachial Plexus Block

The purpose of this study is to determine if bupivacaine (75% levobupivacaine plus 25% racemic bupivacaine) with vasoconstrictor is effective and safety as ropivacaine in brachial plexus block for orthopedic surgery.

The intoxication by Bupivacaine is considered life threatening. Currently the most safety local anesthetic in substitution to bupivacaine is ropivacaine, however in Brasil there is a bupivacaine mixture of 75% levobupivacaine plus 25% racemic bupivacaine. The research design is:

Patients involved: 48; age: 18 to 40 years old; both sex; ASA I and II. Surgery: elective upper extremity orthopedic surgery. Anesthesia technique: brachial plexus block. Primary endpoint: cardiovascular safety; analysis by continuous Holter. Secondary endpoint: anesthetic and analgesic efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Patients involved: 48; ASA I and II;
* Surgery: elective upper extremity orthopedic surgery.

Exclusion Criteria:

* Contraindications to anesthesia technique and/or to local anesthetic;
* Participation in different trials in the last two months;
* Antiretroviral users;
* Obesity.
Intensive Combo Chemo With Autologous BM Rescue for Metastatic Breast Cancer

To determine the therapeutic efficacy of high-dose cyclophosphamide and BCNU with autologous bone marrow transplantation after initial tumor cytoreduction for patients with receptor-negative metastatic breast carcinoma and to determine the optimal timing of CyBCNU-ABMT after initial development of metastatic breast carcinoma


Eligibility Criteria:
Inclusion Criteria:

* breast carcinoma at first clinical evidence of metastatic disease
* must have measurable disease by physical exam, x-ray, or scan
* Age \< or equal to 55
* performance status 0-2

Exclusion Criteria:

* can't have had more than one prior chemotherapy regimen
* can't have had concurrent hormonal therapy
* no brain metastases
* no previous pelvic radiation
* no history of another malignancy
Prognostic Factors in NOP-LBBB After TAVI

The goal of this observational study is to find prognostic factors in patients with a new-onset persistent left bundle branch block (NOP-LBBB) after transcatheter aortic valve implantation (TAVI). The main question it aims to answer is:

Are there any factors influencing heart failure or death risk during the year following TAVI in patients with NOP-LBBB ? Participants will have data collection about TAVI procedure and clinical evolution during a one-year follow-up.


Eligibility Criteria:
Inclusion Criteria:

* New-onset persistent left bundle branch block after transcatheter aortic valve implantation

Exclusion Criteria:

* Pre-existing left bundle branch block
* Pre-existing right bundle branch block
* Pre-existing permanent pacemaker
* Immediate procedural mortality (death ≤72 h post-procedure)
Lung Ultrasound in COVID-19 Patients

To assess the prognostic performance of an early global LUS score with respect to the mortality in ICU and duration of ventilation.

This is an international multicenter cohort study on data collected between March and April 2020. The first available lung ultrasound examination that used a 12-regions approach was used to calculate the global LUS score.

Patients are included if they fulfilled the following criteria: 1) admitted to one of the participating ICU; 2) for invasive ventilation; 3) for respiratory failure due to confirmed COVID-19; and 4) having had a LUS examination performed within the first week of start of invasive ventilation.

The primary and secondary outcomes were liberation from invasive ventilation and mortality.

Demographic, clinical and outcome variables will be presented as percentages for categorical variables and as medians with interquartile ranges (IQR) for continuous variables.

Receiver operating characteristics (ROC) analysis will be used to derive the prognostic discriminatory performance of global LUS score in determining succesful extubation and mortality at day 28. The Youden index will be used to derive the optimal cut-off. The association of global LUS with unfavourable outcomes are analyzed with Cox proportional hazard analysis (for successful extubation and alive at day 28), logistic regression models (mortality at day 28). Hazard ratio or odds ratio with 95% confidence intervals were calculated for each outcome.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to an ICU participating in this study between February 1, 2020 and April 30, 2020
* Confirmed with reverse transcriptase polymerase chain reaction (RT-PCR) COVID-19 infection
* Having had received invasive ventilation
* Having had examined at least once with lung ultrasound under invasive ventilation

Exclusion Criteria:

* Age \<18 years
* First examination with LUS in patients already under extracorporeal membrane oxygenation (ECMO) support.
Trial of Thiamine Supplementation in Cambodia

Beriberi is a potentially fatal disease caused by vitamin B1 (thiamine) deficiency that still occurs in Southeast Asia despite near eradication elsewhere. Mothers with a diet low in thiamine produce thiamine-poor milk, putting their infants at a high risk of developing thiamine deficiency and beriberi. There is also a growing body of evidence suggesting thiamine deficiency not severe enough to cause clinical symptoms may negatively effect cognitive development and functioning of the infant. Since human milk should be the sole source of nutrition for babies during the first six months, maternal thiamine intake must be improved to combat this disease.

The investigators' recent study of thiamine-fortified fish sauce in Cambodia showed that fortification could increase maternal and infant thiamine status'. However, centrally produced fish sauce may not reach the poorest communities who make their own fish sauce, and fish sauce is not consumed in all regions where we find thiamine deficiency. Salt, by contrast, is a common condiment in most regions of the world and has proven to be a successful global fortification vehicle for iodine.

Suboptimal maternal thiamine intake puts exclusively breastfed infants at risk of low thiamine status, impaired cognitive development, and infantile beriberi, which can be fatal. Thiamine fortification of salt is a potentially low-cost and sustainable means of combating suboptimal thiamine status; however knowledge gaps must be filled before thiamine fortification can proceed. In this study, mothers will consume thiamine supplements in order to model the thiamine dose required to optimize human milk thiamine concentrations for the prevention of beriberi. Other thiamine biomarkers will be assessed, and usual salt intake will be measured. Finally, the investigators will assess the effects of early-life thiamine exposure on infant neuro-cognitive development.

(see full protocol)

Eligibility Criteria:
Inclusion Criteria:

Mothers of a newborn who:

* are aged 18 - 45 years
* had a recent normal pregnancy (i.e. no known chronic conditions, no preeclampsia, gestational diabetes etc), and the singleton infant was born without complications (e.g. low birth weight (\<2.5 kg), tongue tie, cleft palate)
* are intending to exclusively breastfeed for six months
* reside in Kampong Thom province, Cambodia, and are not planning to move in the next six months
* are willing to consume one capsule daily from 2 weeks through to 24 weeks postpartum
* are willing for her entire household consume only salt provided by the study team
* are willing for the following biological samples to be collected: a maternal venous blood sample and human milk sample at 2 weeks postpartum, a human milk sample at 4 and 12 weeks postpartum, and maternal and infant blood samples and a human milk sample at 24 weeks postpartum.

Exclusion Criteria:

Mothers of a newborn who:

* are currently taking or has taken thiamine-containing supplements over the past 4 months
* are currently participating in nutrition programs beyond normal care
Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AFib Stroke Prevention

A multi-center, randomized controlled 2-arm trial comparing the effectiveness of an innovative shared decision-making pathway and usual care for Atrial Fibrillation Stroke Prevention

This study will test to see if a new type of decision-making process tool, called a Shared Decision Making Pathway, can make a difference in decreasing the risk of stroke due to a condition called Atrial Fibrillation (AFib.) This online tool is designed to help doctors and patients decide together on treatment options for AFib.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 y/o
* Non-valvular atrial fibrillation or atrial flutter (AFib)
* CHA2DS2-VASc stroke score of:

  * Men: 1 or more
  * Women: 2 or more
* Able to consent in English or Spanish (if resources allow) and follow study instructions

Exclusion Criteria:

* Moderate to severe mitral stenosis
* Mechanical valve replacement
* Absolute contraindication to anticoagulation (Based on clinician judgment)
* Indication for anticoagulation therapy for a condition other than atrial fibrillation
* Left atrial appendage exclusion (by surgery or device placement)
* At the clinical discretion of the investigator
Study to Gather Information About the Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following an Acute Heart Attack

The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works on top of a dual antiplatelet therapy (acetylsalicylic acid +/- clopidogrel) in patients following a recent heart attack (myocardial infarction) that happens when a blood vessel in the heart suddenly becomes blocked. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be 45 years of age or older, at the time of signing the informed consent
* Acute myocardial infarction (excluding MI associated with PCI or CABG revascularization procedures) with:

  * clinical symptoms of acute myocardial infarction AND
  * elevated biomarkers of myocardial necrosis (creatine kinase-muscle and brain isoenzyme \[CK-MB\] or cardiac troponins) AND
  * at least one of the following risk factors need to be fulfilled:

    * Age ≥ 65 years
    * Prior MI (before the index AMI event)
    * Prior peripheral arterial disease
    * Diabetes Mellitus
    * Prior coronary artery bypass grafting (CABG) AND
  * initial angiography and revascularization procedures, either PCI or CABG, as treatment for the index event performed before randomization. (Note: a planned, staged PCI procedure can be performed after randomization)
* Plan for dual antiplatelet therapy (ASA + P2Y12 inhibitor) after hospital discharge for the index AMI
* Randomization during hospitalization for the index AMI event and latest within 5 days of hospital admission
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent has to be signed before any study-specific procedure.

Exclusion Criteria:

* Hemodynamically significant ventricular arrhythmias or cardiogenic shock at time of randomization
* Active bleeding; known bleeding disorder, history of major bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months of randomization
* Planned use or requirement of full dose and long term anticoagulation therapy during study conduct.
Esthetic and Radiographic Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall

The aim of this prospective study was to evaluate the soft and hard tissue changes of immediate implant placement with buccal bone augmentation in sites with thin labial bone wall in the anterior maxillary zone.

The objective of this prospective controlled clinical trial is to compare the esthetic and radiographic outcomes following immediate implant placement with thin or dehiscences buccal plate using bone augmentation in combination with an absorbable collagen membrane. Subjects in need of one implant replacing tooth to be removed in the maxilla within region 13-23 are included. At least 15 patients are recruited. No implant-supported temporary restorations are used during the first 4 months. After a screw-retained provisional phase of 2 months, a ﬁnal impression is taken at implant level and take-in definitive crown. Patients are recalled for oral hygiene maintenance and prosthetic controls every 6 months for the entire duration of the study.

Eligibility Criteria:
The inclusion criteria were as follows:

1. 18 to 70-year-old;
2. Stable periodontal and systemic health (American Society of Anesthesiologists classification I or II);
3. Single maxillary anterior teeth (canine to canine);
4. Bone thickness less than 1mm at 4mm apical to cementum-enamel junction (CEJ-4)；
5. Presence of adjacent nature tooth;
6. Good compliance;
7. No palatal vertical bone loss;
8. Good oral hygiene.

Exclusion criteria are as follow:

1. Uncontrolled periodontal or systemic disease;
2. General psychiatric contraindications;
3. More than 20 cigarettes per day;
4. History of head and neck radiotherapy；
5. Pregnant or expecting to be pregnant;
6. Patients with local or generalized healing limitations;
7. Bruxism or other destructive parafunctional habits;
8. Drug abuse or alcohol abuse.