cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of 2 Dosing Regimens of T1225 Eye Drops 1.5% Versus Oral Azithromycin in Treatment of Trachoma

To assess in children the efficacy and safety of 2 dosing regimens of T1225 1.5% eye drops, in comparison to a reference product, single-dose oral azithromycin (AZM) 20 mg/kg, for the treatment of active trachoma. Evaluation of clinical efficacy was primary (% of clinical cure at Day 60 in Per Protocol Set), microbiological evaluation was secondary

The aim of the present study was to compare the efficacy of the dosing regimen which was demonstrated in pharmacokinetic studies to be the best candidate for trachoma treatment (T1225 1.5% eye drops BID for 3 days) with a shorter duration of treatment (T1225 1.5% eye drops BID for 2 days) and with a single oral administration of AZM (20 mg/kg) in patients suffering from active trachoma. The study was to be performed in approximately 600 children (aged 1 to 10 years) from Guinea Conakry and Pakistan.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 1-10 years;
* written informed consent by legally acceptable representative;
* TF+ TI0 (trachomatous inflammation - follicular) or TF+TI+ (trachomatous inflammation - follicular and intense) on simplified World Health Organisation (WHO) grading system

Exclusion Criteria:

* Trichiasis or corneal opacity;
* palpebral deformation;
* clinically significant ocular abnormality;
* ocular infection;
* organic amblyopia;
* hypersensitivity to treatments' components;
* immunosuppressive conditions;
* systemic AZM or steroids;
* topical ophthalmic antibiotics within 3 months;
* other systemic antibiotics within 1 month;
* topical (ocular, nasal, bronchial etc.) treatments within 1 week;
* systemic non-steroidal anti-inflammatory drugs on day before Day 0
Neural Correlates of an Olive Oil Essence

The aim of the current study was to investigate the effect of a low fat meal in comparison to a low fat meal dosed with the fatfree essence of olive oil.


Eligibility Criteria:
Inclusion Criteria:

* male
* heatly

Exclusion Criteria:

* lactose intolerance
* fMRI cotraindications
Improving Rehabilitation In Sarcopenia (IRIS)

This randomized, double-blind, placebo-controlled supplementation trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation concurrent with regular, controlled physical activity would increase the efficacy of physical rehabilitation in old adults suffering from sarcopenia

This randomized, double-blind, placebo-controlled supplementation trial tested the hypothesis that nutritional supplementation with whey protein, essential amino acids - mainly leucine - vitamin D and calcium concurrent with regular, controlled physical activity would increase the efficacy of physical rehabilitation in old adults suffering from sarcopenia

Eligibility Criteria:
Inclusion Criteria:

* age 65 years or older
* admission for physical rehabilitation
* sarcopenia, measured with bioelectrical impedance assessment (BIA) + handgrip strength and gait speed
* Mini Mental State Examination ≥18
* Informed consent

Exclusion Criteria:

* Any malignant disease during the last five years
* Known kidney failure (previous glomerular filtration rate \<30 ml/min);
* Known liver failure (Child B or C)
* Psychiatric disease
* Endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis)
* Indications related to the study product:

More than 10 µg (400 IU) of daily Vitamin D intake from medical sources More than 500 mg of daily calcium intake from medical sources. Adherence to a high energy or high protein diet up or use of protein containing or amino acid containing nutritional supplements up to three months before starting the study.

* Known allergy to milk, milk products or other components of the proposed interventions
* Indication to or ongoing artificial nutrition support
* Inclusion in other nutrition intervention trials
* Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
* Refusal
Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors

This project will be based on three studies over a period on three years. The first study is a dose response study that includes 30 breast cancer survivors. They will receive a total of 5 laser treatments with 4-6 weeks intervals The second study is a double-blind randomized controlled trial, that includes 60 breast cancer survivors. 30 of those will receive active intervention and 30 will receive placebo laser treatment and act as controls. Based on the results of the dose response study, a treatment consists of three to five laser treatments every 3 weeks. The third and last study is a one-year follow-up on study two. The conditions are evaluated before and after each treatment by questionnaires, vaginal fluid pH values, punch biopsies and vaginal and urine microbiome. The studies is conducted at the Department of Obstetrics and Gynaecology at Randers Regional Hospital in collaboration with Department of Obstetrics and Gynaecology and Department of Oncology at Aarhus University Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer survivor in endocrine therapy
* Symptomatic genitourinary symdrom of menopause with vaginal discomfort and/or dyspareunia
* Able to read and understand Danish
* Able to give written informed consent

Exclusion Criteria:

* Pelvic organ prolapse ≥ stage 2 according to the Pelvic Organ Prolapse Quantification staging system
* Use of non-hormonal/hormonal vaginal therapies (1 and 12 months prior to the baseline visit, respectively)
* Use of Chemotherapy (6 months prior to the baseline visit)
* Acute urinary tract infection or active genital infection
* History of vaginal reconstructive surgery
Effect of Different Supralottic Airway Devicess on Optic Nerve Sheath Diameter

Direct laryngoscopy and tracheal intubation are associated with increases in intraocular pressure (IOP), intracranial pressure (ICP), heart rate (HR), and blood pressure. The use of supraglottic airway devices (SADs) are known to be beneficial in overcoming the disadvantages of laryngoscopy and tracheal intubation, especially ocular and pressure stress responses. In recent years, it has been reported that ultrasonographic measurement of optic nerve sheath diameter (ONSD) can be used in the diagnosis of increased ICP. The aim of our study is to compare the effects of Proseal laryngeal mask airway (pLMA), Suprem laryngeal mask airway (sLMA) and I-gel on hemodynamic response and ONSD during insertion in adult patients.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status of I-II
* elective surgery
* non-ophthalmic procedures
* 1-2 h duration
* general anaesthesia
* supine position

Exclusion Criteria:

* Mallampati and ASA status ≥III,
* a history or suspect of difficult airway,
* previous intracranial/ocular surgery,
* cerebral edema/high intracranial pressure,
* glaucoma,
* uncontrolled hypertension

  -, diabetic retinopathy,
* obstetric patients,
* those who refused to participate in the study
Electronically Connected Health Coaching in Type 2 Diabetes

Patients with Type 2 Diabetes randomly allocated to the intervention arm (health coaching + smartphone-based health promotion software) will have significantly better Hemoglobin A1c levels at 6 months post-intervention than patients with Type 2 Diabetes allocated to the control arm (health coaching alone).

Inclusion criteria: all participating patients have been diagnosed with Type 2 Diabetes, are between 25 and 70 years of age, have a regular primary care physician, and have HbA1c levels \> or = to 7.3.

Exclusion criteria: Axis I and II psychiatric disorders.

Primary outcome: HBA1c at 6 months follow up.

Secondary outcome: Centre for Epidemiological Studies Depression Scale

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Type 2 Diabetes
* Fluency in English and/or Spanish

Exclusion Criteria:

* \> 75 years of age
Fluorescence, Light-microscopy, Ultrasound Integrated / Intraoperative Diagnosis to MAXimise Resection

The present study aims to evaluate and compare with the histopathological analysis the various margin-assessment systems, including ultrasound, florescence, brightfield vision, new optical filters and microscope image post-processing systems, for the treatment of High Grade Gliomas (HGGs)

Extent of Resection represents the cornerstone of surgery in terms of improving the prognosis of the patient with High Grade Gliomas, but total removal of neoplastic tissue is prevented by the amount of infiltration that is undetectable either by traditional preoperative MRI techniques or by the naked eye during surgery. Several techniques are currently used to define margins in the surgical setting, but the literature available on them to date is mostly focused on the assessment of postoperative GTR (Gross Total Resection), which tends to underestimate neoplastic tissue infiltration.

The evaluation of the efficacy of these techniques in detecting tumour infiltration by comparing them with the histopathology response on intraoperative biopsies taken after the debulking phase of the neoplasm could overcome this sensitivity limitation.

The study therefore intends to develop an algorithm that allows to discern between tumour infiltration and healthy parenchyma by means of different margin-assessment techniques in order to maximise the extent of resection in patients with HGGs.

Eligibility Criteria:
Inclusion Criteria:

Patients with radiological, clinical and anamnestic picture compatible with a new diagnosis of Glioblastoma for whom there is an indication for cytoreductive surgery at the Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta.

Exclusion Criteria:

* Patients aged less than 18 years at the time of radiological diagnosis
* Patients who have received radiation therapy in the same area as the neoplasm of interest
* Patients contraindicated to 5-ALA administration
* Patients whose neoplasm is in close proximity to functionally eloquent areas (Primary Motor, Broca's, Wernicke's areas)
* Patients who have not given their consent to take part in the research
Open Label, Multicenter, Real World Practice of Durvalumab (Imfinzi PMS)

The objectives of this study are to assess safety and efficacy of Imfinzi (durvalumab) in a real world setting in patients treated with Imfinzi under the approved indication in Korea.

Primary objective : To assess safety of Imfinzi for patients treated with Imfinzi under the approved indication in Korea

Outcome Measure:

* Safety (adverse event (AE), serious adverse events (SAE), adverse drug reaction (ADR), serious adverse drug reaction (SADR), adverse events of special interest (AESI), adverse events leading to discontinuation (DAE), and adverse events leading to deaths (fatal AE))
* Dose interruptions
* Duration of treatment
* Reason for treatment discontinuation Secondary objective: To assess efficacy of Imfinzi for patients treated with Imfinzi under the approved indication in Korea

Outcome Measure:

* Progression free survival (PFS)
* Objective response rate (ORR)
* Duration of response (DoR)

Eligibility Criteria:
Inclusion Criteria:

* Eligible for Imfinzi treatment according to the approved label
* Provision of signed and dated written informed consent by the patient or legally acceptable representative

Exclusion Criteria:

* Current participation in any interventional trial
* Other off-label indications according to the approved label
An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure

The purpose of this early feasibility study is to evaluate the safety and feasibility of the device for percutaneous shunting of the interatrial septum and improvement of heart failure related symptoms. The primary goal is to determine if the device is safe to use. The findings from this study may be used to refine the intended patient population, the design of the device, or develop a subsequent randomized study.

This is a prospective, multicenter, single-arm early feasibility study (EFS) to evaluate the safety of the InterShunt PAS-C System in subjects with heart failure, and the feasibility of PAS-C to improve heart failure related symptoms. The device is used to create an interatrial shunt by removing septal tissue to reduce left atrial pressure. There is no permanent implant. Enrollment will include 20 subjects with documented heart failure who may benefit from the reduction of left atrial pressure. The primary objective of this study is to characterize the safety of using the PAS-C System by evaluating the proportion of subjects who experience a major adverse cardiac or cerebrovascular event or systemic embolization through one month after the procedure. The findings from this study will be used to develop a subsequent pivotal study.

Eligibility Criteria:
Inclusion Criteria:

* NYHA Class II at screening with a prior history of greater than NYHA Class II, OR NYHA Class III at screening, OR ambulatory Class IV at screening: with documented medical history of heart failure for at least 6 months prior to the screening visit.
* At least one hospitalization for heart failure OR treatment with IV diuretics for heart failure OR elevated BNP in the prior 12 months.
* Receiving maximally tolerated guideline directed medical therapy for Heart Failure management.
* LVEF ≥ 20% and ≤ 40% according to baseline echocardiography.
* Resting right heart catheterization demonstrates elevated PCWP compared to right atrial pressure.

Exclusion Criteria:

* Any of the following within the prior 6 months: Stroke, thromboembolism, severe or advanced heart failure such as Stage D heart failure, non-ambulatory NYHA Class IV, cardiac index less than 1.8 L/min/m2, LVEDD \> 8 cm, or received inotropic therapy for LVEF less than 20%.
* Any of the following within the prior 3 months: Myocardial infarction percutaneous cardiac intervention, CABG, on cardiac transplant list, cardiac resynchronization therapy implant, AICD implant, or indicated for coronary revascularization at the time of enrollment.
* Transseptal procedure or percutaneous cardiac intervention planned within the next 6 months.
* Chronic pulmonary disease requiring continuous home oxygen or hospitalization within the prior 12 months for pulmonary disease.
* Patent foramen ovale (PFO) device or atrial septal defect (ASD) device.
* BMI \> 40.
* Anatomic anomaly that precludes creation of interatrial shunt.
Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients

This is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding and development of thrombocytopenia in the medical ICU population.

This is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding and development of thrombocytopenia in the medical ICU population. We expect the null hypothesis to be proven true. One hundred subjects will be enrolled in this prospective, randomized, double-blind (concealed allocation) pilot study of consecutive medical ICU patients to one of two pharmacologic VTE prophylaxix treatment arms. (1) Primary endpoints include hemoglobin, hematocrit, \& platelet counts. blood product utilization, bleeding complications (any), Steady State Functional Factor Xa activity (for post hoc analysis), non-study pharmacologic VTE prophylaxis (when estimated CLcr \< 30ml/min), and days not treated with study drug or treated with alternative agent Secondary/ Additional Data to be collected include patient demographics, primary \& secondary diagnoses, central venous access, and sequential compression device utilization.

Eligibility Criteria:
Inclusion Criteria:

1. Ability or legally authorized representative (LAR) to provide informed consent
2. Adult who has not had surgery within 10 days, admitted to the Sentara Norfolk General Hospital ICU Medical Teaching Services for any reason.

Exclusion Criteria:

1. Active or suspected bleeding
2. Platelet count less than 100,000 per microliter (mm3) of blood
3. Thrombolytic or anticoagulant treatment (including any doses of prophylactic UFH, LMWH or fondaparinux) during the current hospitalization
4. Initial estimated CLcr \< 30 ml/min as determined by the Cockcroft-Gault equation
5. Initial labs indicative or suggestive of rapidly rising serum Creatinine (\>1 mg/dL/day)
6. Pregnancy (for medicolegal considerations)
7. Patients with or expecting to require an epidural catheter
8. Patients who are expected to have an immediate (within 24h) need for surgery
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients

The purpose of this study is to evaluate the effects of Mindfulness Based Eating Awareness Training (MB-EAT) for patients who have had bariatric surgery on their weight and mental and physical health compared to patients who do not do this group. All participants will complete questionnaires evaluating eating and mental health before and after the group and 6 and 12 months later. They will have blood pressure readings at these times and complete a questionnaire about their digestive health. Our hypothesis is that participants will maintain their weight loss after bariatric surgery and have improvements in the other outcomes.

MB-EAT may be helpful for reducing emotional eating, overeating and grazing, eating patterns that can lead to weight gain after bariatric surgery. Participants will receive MB-EAT 6 months or more following bariatric surgery. They will be randomly assigned to receive MB-EAT right away or 8 weeks later. Individuals in the group starting in 8 weeks will serve as a waitlist control group.The primary outcome measures will be changes in self-reported eating problems, depression, anxiety, and mindfulness. There will be a follow-up at 6 months and 12 months to establish stability of symptoms post-intervention. Participants will receive one introductory information session about the MB-EAT program, as well as 8 MB-EAT scheduled consecutively over eight weeks. Each session is approximately two hours in length. During MB-EAT, participants will practice mindfulness to help improve their decision making abilities about when and how much to eat. Through MB-EAT, participants will learn to address mindless or out-of-control eating, which can lead to weight gain. Homework will include daily meditations and mindful eating exercises.

Eligibility Criteria:
Inclusion Criteria:

1. Post-bariatric surgery patients recruited from the Toronto Western Hospital-Bariatric Surgery Program (TWH-BSP) who are six months or more post-surgery, are experiencing self-reported difficulties adhering to post-surgery eating guidelines, and can commit to attending the group.
2. Fluent in English.
3. Have the capacity to provide informed consent.

Exclusion Criteria:

1. Active suicidal ideation.
2. Active serious mental illness (i.e., psychotic disorder, bipolar disorder).
3. Active severe depression (i.e., current major depressive disorder diagnosis and PHQ-9 score \> 20 \[severe depression\]).
4. Active severe anxiety (i.e., current anxiety disorder diagnosis and GAD-7 score \> 15 \[severe anxiety\]).
5. Active symptoms of post-traumatic stress disorder (i.e., current diagnosis of post-traumatic stress disorder).
Increased Body Temperature Post Tracheostomy: a Retrospective Study

Tracheostomy is one of the most common procedures in intensive care units. Post-tracheostomy increased body temperature within 24 hours is common. However, frequently sepsis workup is performed along with initiation of broad spectrum antibiotic therapy. We will investigate the incidence of post tracheostomy fever and whether retrospectively the increased temperature indicated development of sepsis or not. The study is retrospective and will be based on data collection.


Eligibility Criteria:
Inclusion Criteria: Patients admitted to the ICU from 1.2020 to 1.2025 who underwent tracheostomy during ICU admission -

Exclusion Criteria: Patients who did not fullfil the above criteria

-
Choice Sets for Advance Directives

There is a large gap between the care seriously ill patients want and the care they receive. Advance directives (ADs) offer an opportunity for patients to express specific end-of-life preferences to avoid unwanted care. As promising as ADs may be for improving the quality of care near the end of life, rates of AD completion remain low and previous efforts to encourage their completion have had limited success. Principles of behavioral economics, such as the effects of defaults and other framing effects, may offer a novel approach to bridge the gap in end-of-life care. The goal of this study is to test whether the framing effect of expanding choice sets can increase the completion of and specification of choices within advance directives.

This study has been designed as two sequential randomized trials to test two separate expanded choice set interventions, with the second randomization enrollment being contingent on results from the first. All enrolled subjects will be asked if they would like to complete an advance directive and will have been randomized to receive either an expanded answer choice set or a standard answer choice, as described in detail elsewhere. Only those subjects who express a desire to complete an advance directive from both arms will then be randomized again in a stratified fashion to receive either a standard advance directive or one with an expanded choice set for the decisions regarding life-sustaining therapy, as described in detail elsewhere.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Proficient in English
* Chronic hemodialysis for minimum 90 days
* Does not currently have a living will

Exclusion Criteria:

* Blindness
* Cognitive impairment that prohibits subject's provision of informed consent
Comparison of Intraoperative and Postoperative Outcomes of Bartholin Gland Marsupialisation Versus Cystectomy

To compare intraoperative and postoperative outcomes of Bartholin marsupialisation versus excision

Bartholin cysts and abscess are commonly seen. Different surgical procedures are done for therapy. Our aim is to compare intraoperative results and postoperative healing of patients undergoing marsupialisation versus excision.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-40, Bartholin cyst/abscess

Exclusion Criteria:

* patients with systemical diseases, patients with recurrent Bartholin abscess
Qualitative Analysis of Hospital Executives, Physician Administrators, and Hospital Legal Counsels' Perceptions of End-of-Life Care

Interviewing hospital executives, physician administrators and hospital legal counsel who work in a hospital setting (academic, governmental, private or community hospital) about their perceptions concerning current and future end-of-life care provided in their facilities


Eligibility Criteria:
Inclusion Criteria:

Informant is a hospital executive, physician administrator or hospital legal counsel in a hospital setting (academic, governmental, private or community hospital) and is able to communicate perceptions verbally through use of English language. All participants will likely be nonveterans

Exclusion Criteria: