cyrilzakka/clinical-trials huggingface dataset:
Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease

This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation in subjects with dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* Dry eyes
* Current use of eye drops for dry eye at least twice daily, on average for at least 3 months

Exclusion Criteria:

* Cataract, laser-assisted in situ keratomileusis (LASIK), or photorefractive keratectomy (PRK) surgery in the last 12 months
* Need to wear contact lenses during the study, or has worn contact lenses in the last 6 months
* Active ocular allergy
Exploring the Value of 18F-AlF-FAPI PET/CT in Assessing the Activity of Thyroid Eye Disease

FAPI PET has been developed as a promising approach for the evaluation of fibroinflammatory, such as in inflammatory bowel disease. This prospective study aims to explore the value of 18F-AlF-FAPI PET/CT in assessing the activity of Thyroid Eye Disease (TED) and investigate whether FAPI PET/CT may be superior to 99mTc-DTPA SPECT/CT for the diagnosis, therapy response assessment, and follow-up of TED.

Subjects with TED underwent 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT for activity assessment within a 10-day period. On 18F-AlF-FAPI PET/CT, uptake in the extraocular muscles was quantified using SUV metrics and target-to-background ratio. On 99mTc-DTPA SPECT/CT, uptake in the extraocular muscles was semi-quantified using the uptake ratio. Activity of TED was determined through comprehensive clinical data. The correlation between SUV metrics and activity status was calculated to explore the value of 18F-AlF-FAPI PET/CT in assessing TED activity. The diagnostic accuracy of 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT in assessing TED activity was compared. Additionally, the correlation of changes in SUV metrics and therapy response will be calculated to explore the value of 18F-AlF-FAPI PET/CT in therapy response assessment of TED.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. Patients diagnosed with TED;
3. Complete understanding and voluntary participation in this study, with the signing of an informed consent form.

Exclusion Criteria:

1. Severe liver or kidney dysfunction;
2. Inability to maintain a supine position for 5 minutes to cooperate with the examination;
3. Suffering from claustrophobia or other psychiatric disorders;
4. Patients planning pregnancy or in the prenatal or lactation period;
5. Other conditions deemed unsuitable for participation in the trial by the investigator.
Interferential Electrical Stimulation and Vasodilatation in Healthy Individuals

Interferential electrical stimulation (IES) increases local blood flow. It is not known whether increases in blood flow may be caused by inhibition of sympathetic activity, mediated by muscle metaboreflex activity. The purpose of this study was to evaluate the effect of IES on metaboreflex activation in healthy subjects.

The study sample consisted of 11 healthy young individuals. All subjects were non-smokers, non-obese and free of any signs or symptoms of disease, as revealed by medical history, physical examination and electrocardiogram at rest and during cardiopulmonary exercise testing. Exclusion criteria were pregnancy, breast-feeding, alcohol or drug abuse, and any medication with potential effects on cardiovascular variables. Subjects were asked not to drink caffeine-containing drinks or exercise for at least 12 and 48 hours, respectively, before the experimental protocols.

Eligibility Criteria:
Inclusion Criteria:

* Subjects are non-smokers
* non-obese
* and free of any signs or symptoms of disease

Exclusion Criteria:

* Pregnancy
* breast-feeding
* alcohol or drug abuse
* medication with potential effects on cardiovascular variables
Therapeutic Patient Education and Cancer Pain

Describe the expectations of therapeutic education for patients in management of cancer pain.


Eligibility Criteria:
Inclusion Criteria:

* Patient with cancer diagnosed for at least one month
* Patient with pain from the tumor or its treatment
* Patients with a life expectancy ≥ 6 months
* Health condition compatible with the requirements of the program (WHO performance scale \< or= 2)
* Age over 18 years
* Patient able to understand, speak and read French
* Absence of cognitive impairment

Exclusion Criteria:

* Primary cancer of the central nervous system or brain metastases
* Disorders of the documented higher functions
* Evolutionary psychiatric pathology
* Drug User
* Abusive alcohol consumption than the WHO recommendations (or 3 glasses of wine per day)
* Refusal to participate
Basic Assessment of Safety and Minimally Invasive Stimulation Via Injectrode

The objectives of this non-significant risk (NSR) study are to evaluate the safety of the short term placement of the Basmati Injectrode for up to 28 days and the efficacy of conducting electrical current to stimulate subcutaneous nerves on the explant date just prior to explant.

This was a prospective, single-center, single-arm, non-randomized study design. A sample of 10 study participants were enrolled into the study, and provided with the placement of a Basmati Injectrode insert with a maximal placement duration of up to 28 days. Subjects who were selected to participate in the trial were healthy volunteers adults with ages 18 years and older without any preexisting condition indicated for treatment. Each subject was followed during the trial period of approximately 45+/-2 days.

Eligibility Criteria:
Inclusion Criteria:

* Sign a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) and understand the study requirements.
* Be 18 years of age or older when written informed consent is obtained.
* Be in good physical and mental health as assessed by a general practitioner.
* Be able to tolerate electrical stimulation (TENS).
* Be willing and able to understand and comply with all study-related procedures during the course of the study.

Exclusion Criteria:

* Have a cognitive impairment or exhibit any characteristic that would limit the study candidate's ability to completely understand and sign a valid, IRB-approved informed consent form.
* Have a positive pregnancy test (conducted during enrollment).
* Have a positive Allergic reactivity to Gold skin test (conducted during enrollment).
* Show symptoms indicative for Covid19 as assessed during enrollment.
* Have a skin condition at the planned surgical location.
* Have a blood coagulation disorder or other indication with the potential to impact the study biocompatibility data in unpredictable ways.
* Have a medical condition that is a contraindication for minimally invasive surgery.
* Be implanted with a cardiac defibrillator or pump.
* Have a history of cardiac arrhythmia with hemodynamic instability
* Be implanted with a neurostimulator.
* Have any active electrical implant of any other kind.
* Have metal implants (particularly in hip).
* Have active infection.
* Have allodynia.
* Take regular use of antiplatelet medications (e.g. aspirin, ticlopidine (Ticlid), clopidogrel (Plavix), tirofiban (Aggrastat) or eptifibatide (Integrilin)).
* Have untreated drug habituation or dependence.
* Have uncontrolled seizures (averaging \> 2 seizures per month).
* Currently require, or be likely to require, diathermy and/or MRI during study duration.
* Have a history of adverse reactions to local anesthetics (e.g. lidocaine).
The Effect Of Therapeutic Touch To Mothers With Preterm Babies

The study was carried to determine the effect of yakson or gentle human touch methods applied by the mothers to their preterm newborns on mother's attachment level and baby's response.

The study was carried out as a randomized controlled experimental research. Population of the study is all of the babies who were hospitalized at the neonatal intensive care unit of a state hospital in Turkey between August 2016 and August 2017 and the mothers of the babies; its sample is 90 mothers and their babies included with randomization method who were matching the criteria who were also hospitalized between these dates.

Eligibility Criteria:
Inclusion Criteria:

Mothers' Selection Criteria

* Mother should not have any defines psychiatric diseases,
* Mother should not have any physical disabilities,
* Mother should be literate and open to communication,
* Should not have transportation problem,
* Should be willing to participate and volunteer for the study.

Babies' Selection Criteria

* Babies should be between 26-34 gestation weeks,
* Should not have congenital abnormalities,
* Babies should not have any health problems that may hinder the practice (Intracranial hemorrhage, sepsis, hemorrhagic diseases, having an operation, etc.).

Exclusion Criteria:

-Participants must have inclusion criterias.
An Endotracheal Tube Inserted to the Level of the Hypopharynx

The goal of this observational study is to assess the incidence of successful ventilation using an ETT inserted orally above the vocal cords in pediatric patients undergoing surgeries. The main question it aims to answer are:

Is the use of an endotracheal tube (ETT), positioned in the hypopharynx with its tip placed just above the vocal cords an easy, safe and effective way for the ventilation of pediatric patients who are undergoing surgery under general anesthesia via orotracheal intubation?

The procedures to be performed in this study are standard of care. They are also used by pediatric anesthesiologists in the oral intubation of pediatric patients suffering from tumor or abscess.

Background: Tracheal intubation can be challenging in the pediatric age group. The difficult airway algorithm is followed starting with ventilation via a facemask. In cases of difficulties in intubation and ventilation, and especially in neonates and small infants, oxygen desaturation can happen very quickly and can be life threatening. The endotracheal tube (ETT), which is readily available and bypasses the tongue of the patient, can provide a safe and efficient ventilation.

Specific Aim (s): In our study, we aim at assessing the incidence of successful ventilation using an ETT inserted orally above the vocal cords in pediatric patients undergoing surgeries. Secondary objectives include comparing the rate of successful ventilation between attending anesthesiologist and residents, assessing the incidence of success at first attempt, incidence of severe hypoxemia (SPO2 less than 85%), and incidence of adverse events such as bradycardia, stomach insufflation, laryngospasm, and desaturation.

Methods: This prospective observational study will include infants and children under 6 years of age who undergo surgeries at the American University of Beirut Medical Center (AUBMC). The tube will be inserted orally above the vocal cords following which ventilation will be attempted. The exclusion criteria include pediatric patients with an existing endotracheal tube, a BMI \> 30 kg/m2, a risk of aspiration or a history of gastroesophageal reflux disease (GERD), and those undergoing emergency surgeries or whose legal guardian/representative is unwilling/unable to provide an written consent. The primary outcome is to assess successful ventilation (chest rise, end tidal CO2 wave and SpO2 levels).

Significance: This ETT technique is simple to implement and use, requiring no special training or equipment. This technique can save time by ensuring patients' oxygenation and ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Infants and children under 6 years of age undergoing surgery
* Legal guardian/representative willing to sign consent

Exclusion Criteria:

* Existing endotracheal tube
* BMI \> 30 kg/m2
* Patient with a risk of aspiration of history of GERD
* Inability or unwillingness of research participant's legal guardian/ representative to give consent
* Need for emergency surgery
* ASA Ⅲ-Ⅳ
* Neonates below 28 days of age
Intravenous AII for the Treatment of Severe Hypotension in High Output Shock: A Pilot Study

The investigators propose a dose finding study to determine the feasibility of Angiotensin II (AII) to increase mean arterial pressure in high-output shock. If AII can be shown to increase mean arterial pressure, this could lead to future pharmacologic development based on the AII hormonal pathway. The investigators propose a 20 patient, randomized, placebo-controlled, blinded study in the treatment of high-output shock. Patients with high-output shock and a cardiovascular SOFA (sequential organ failure score) score of \> 4 will be eligible. In addition, patients must already be receiving cardiac output monitoring and have a cardiac index \> 2.4 L/min/ 1.73 m2. Patients will be randomized to intravenous AII or saline in a blinded fashion. There will be 10 patients in each arm. This is a safety and dose finding feasibility study. The investigators are starting with a small cohort consistent with similar types of studies. The investigators estimate that ten patients in each arm will generate a basis for determining if there is sufficient signal for AII to improve blood pressure at the doses outlined. The primary endpoint in the study will be the effect of AII on the standing dose of norepinephrine which is required to maintain a mean arterial pressure (MAP) of 65 mmHg. Secondary endpoints will be the effect of AII on urine output, serum lactate, and creatinine clearance. 30 day post dose mortality will also be assessed. Subjects discharged prior to day 30 will be contacted by telephone for this assessment.


Eligibility Criteria:
Inclusion Criteria:

1. High-output shock
2. Cardiovascular SOFA score of \> 4
3. Cardiac Index \> 2.4 liters/min/BSA 1.73m2
4. Indwelling arterial line already present as part of standard care
5. Age \> 21 years of age
6. Signed consent form
7. Use of indwelling urinary catheter as standard care expected at least for 12 hours during the study interventions

Exclusion Criteria:

1. Patients with acute coronary syndrome
2. Patients with a known history of vasospasm
3. Patients with a history of asthma
4. Patients currently experiencing bronchospasm
5. Patients with active bleeding with an anticipated need for \> 4 units of PRBC or Hemoglobin \< 7g/dL or any other condition that would contraindicate drawing serial blood samples
Study of a Predictor for Cervix Cancer

Non operated cervix cancer are usually treated by radio-chemotherapy. Non control local rate is inexplicably close to 30%. However, important volume of those tumors and their hypoxia degree induce phenomenon of pathologic angiogenesis, explaining these therapeutic failures.

Persistence of tumor hypoxia could be a predictive factor of local control

HPV linked cervix cancer is the second most prevalent form of female cancer. It's also the leading cause of death by cancer in Asia, South America and Africa. Hopefully, screening program lead to a 50 % of mortality reduction during the past 40 years. Classic therapeutic strategy consists of external pelvic radiation therapy associated with chemotherapy and followed by brachytherapy. Curative surgical removal is realized 4 to 6 weeks after radiation therapy. However relapse rate is frequent (20 to 30%). Biological mechanisms involved in this high relapse rate are not understood.

Nevertheless, it is suggest that initial hypoxia of cervix tumor during 20 Gy radiation therapy is a pejorative prognostic factor. At the opposite, the amelioration of tumor vascularisation during 20 Gy radiation therapy is a positive prognostic factor. It's possible that an amelioration of hypoxia lead to lesser tumor resistance to radiotherapy. However such possibility has to be test during clinical trial.

Thus, the objective of ANOXICOL study is to evaluate the predictive value of persistent hypoxia, during 20 Gy radiation therapy associated with chemotherapy, for local control of cervix cancer.

Eligibility Criteria:
Inclusion Criteria:

* cervix epidermoid cancer or adenocarcinoma : I to IIIB
* treatment by radiochemotherapy
* ECOG ≤ 1
* social and psychological compliance for standard treatment of radiochemotherapy for cervix carcinoma
* patient affiliated to health insurance system
* signed informed consent

Exclusion Criteria :

* contraindication to chemoradiotherapy
* resequable cervical cancer
* para-aortic metastases histologically proven
* inability to perform an abdominal MRI or a PET Scan
* contraindications related to MRI: pacemaker, vascular clip, and all devices incompatible with the electromagnetic field generated by MRI
* unbalanced diabete
* administration of EPO
* transfusion within 3 days before the first biopsy
* creatinine clearance under 60 mL / min;
* ANC \<1500 / mm3 and Platelets \<120,000 / mm3
* neuropathy, diabetes (fasting glucose greater than 140 mg / l) or any other condition that strongly contraindicates concomitant chemotherapy with radiotherapy
* sigmoid diverticulitis, Crohn's disease or systemic disease, collagenose
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.

The purpose of this study is to understand the safety and effects of a combined influenza and COVID-19 vaccine. This combined vaccine is compared to separate vaccines for the protection against influenza and SARS-CoV-2. Influenza and COVID-19 are diseases that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. Giving both influenza and COVID-19 vaccines together against influenza and SARS-CoV-2 could provide great benefits to both patients and caregivers in terms of simple and easy care. Around 8550 participants will be assigned into 1 of 8 vaccination groups (Group A, B, C, D, E, F, G or H) by chance.

Cohort 1: Approximately 450 participants will be assigned by chance to one of the following:

* Group A:Influenza and COVID-19 combination A vaccine, given at the same time in one arm and placebo (an injection consisting of just salt water and no medicines in it) in the opposite arm.
* Group B: COVID-19 vaccine, given at the same time to one arm and licensed influenza vaccine in the opposite arm.

Cohort 2: Approximately 4500 participants will be assigned by chance to one of the following:

* Group C: Influenza and COVID-19 combination B vaccine, given at the same time in one arm and placebo in the opposite arm.
* Group D: COVID-19 vaccine, given at the same time in one arm and licenced influenza vaccine in the opposite arm.

Cohort 3: Approximately 3600 participants will be assigned by chance to one of the following:

* Group E: Influenza and COVID-19 combination B vaccine.
* Group F: COVID-19 vaccine.
* Group G: Licenced influenza vaccine.
* Group H: Investigational influenza vaccine.

All participants in cohort 1 and cohort 2 will receive 2 injections and participants in cohort 3 will receive 1 injection as per their assigned study group at Visit 1. The participants will be followed for about 6 months. During this time, researchers will assess safety and the body's reaction to the vaccination over approximately 6 months. This will help understand if the study medicine is safe.


Eligibility Criteria:
Inclusion Criteria:

* Participants 18 through 64 years of age (or the minimum age of consent in accordance with local regulations) at Visit 1.
* Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

Exclusion Criteria:

* Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration, or ongoing receipt of chronic antiviral therapy with activity against influenza.
* Vaccination with any investigational or licensed COVID-19 vaccine within 6 months (175 days) before study intervention administration.

Please refer to the study contact for further eligibility details
Pectopexy for Apical Prolapse Management

This study was designed to evaluate the efficacy of pectopexy for treatment of apical pelvic organ prolapse at follow up at 12 months. Investigator also evaluates complications, improvement of symptoms, quality-of-life outcomes and patient satisfaction with surgery.

Assessment of restoration of normal pelvic anatomy and lower urinary tract symptoms using transperineal ultrasound

Pelvic organ prolapse (POP) substantially affects the quality of life (QOL) of women, with a global prevalence of 20% to 65% .Surgery is the major treatment option for patients with POP at POP Quantification (POP-Q) stage ≥II, especially after failure of conservative treatments . Apical pelvic organ prolapse is a common issue in Egypt with significant incidence rate due to many predisposing factors including increasing age, higher gravidity and parity (especially the number of vaginal births .

Apical support is the most important factor for the successful outcome of pelvic reconstruction surgery. Apical suspension can be performed transabdominally or transvaginally using native tissue or a synthetic mesh . Abdominal sacropexy is considered now the gold standard operation for treatment of apical pelvic organ prolapse . However , many intraoperative complication can occur including hemorrhage or transfusion or both occurred in 4.4% , intestinal injury or rectal injury in 1.6% (0.4% to 2.5%),and ureteral injury in 1.0% of cases. Postoperative complications include paralytic ileus in 3.6%.transient femoral nerve injury and vertebral osteomyelitis . Sacropexy also has a long steep learning curve .

Pectopexy has been in 2011 where synthetic mesh is fixed to the pectineal ligaments bilaterally.This surgery is presumed to have fewer complications because the surgical field is limited to the anterior pelvis, with a decreased risk of injury to the adjacent organs. The technique is suitable for surgeons seeking an attractive alternative for patients in a context of high morbidity and/or with difficult access to the promontory . However, adequate evidence to support this surgical option still needs further studies.

Eligibility Criteria:
Inclusion Criteria:

* Apical prolapse Stage 2-4 acc. to POP-Q system
* Uterine preservation or after hysterectomy
* Age \> 18 years old.
* Sexually active or not.

Exclusion Criteria:

* Pregnancy or up to 6 months postpartum.
* Current Urinary tract infection proved by urine analysis or urine culture.
* Patient unfit for surgery.
* Previous suspension operations.
* Uncontrolled diabetic patients