cyrilzakka/clinical-trials huggingface dataset:
Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy, Psychological Distress, Sexual Function, Urethral and Bladder Wall Structure and Blood Flow in Women With Stress Urinary Incontinence: a Randomized Controlled Study

To assess the impact of Duloxetine and Imipramine on therapeutic efficacy, psychological distress, sexual function, bladder wall structure and blood flow in women

To assess the impact of Duloxetine and Imipramine on therapeutic efficacy, psychological distress, sexual function, bladder wall structure and blood flow in women

Eligibility Criteria:
Inclusion Criteria:

- Stress urinary incontinence

Exclusion Criteria:

1. Take monoamine oxidase
2. Myocardial infarction critical,cardiovascular insufficiency (such as room blocking, arrhythmia, blood-soaked heart failure, myocardial infarction, stroke and excessive heartbeat).
3. Allergy to duloxetine or imipramine
4. Uncontrolled angular glaucoma patients
5. Pregnant women
Efficacy of Trimetazidine in Diabetic Patients

Subclinical diastolic dysfunction represents the early phase of diabetic cardiomyopathy and is a common complication among type 2 diabetic patients that increases mortality rate among those patients and can progress to heart failure with preserved ejection fraction. Trimetazidine is an anti-ischemic agent widely used in the treatment of coronary artery disease and it has positive effects on energy metabolism in heart failure.

Therefore, we hypothesized that trimetazidine may have potential benefit on the amelioration of the inflammatory insult and improving the clinical outcomes in patients with diabetic cardiomyopathy especially if applied in the early stages.


Eligibility Criteria:
Inclusion Criteria:

1. Age from 40-75 years
2. Patients with echocardiographic evidence of grade I or II diastolic dysfunction with LVEF ≥50%

Exclusion Criteria:

1. Patients with valvular, congenital or ischemic heart disease.
2. Patients with inadequately controlled hypertension (blood pressure\>140/90 mm Hg)
3. Patients with HbA1c% \<10 %
4. Patients with history of intolerance or allergic response to TMZ
5. Patients with severe liver dysfunction or severe renal dysfunction (creatinine clearance \< 30 ml/min)
6. Patients with other significant comorbidities such as malignancy, significant psychiatric illness, autoimmune diseases.
7. Patients with Parkinson's disease or motor disorders
8. Pregnancy and breast feeding
Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (UK)

This is a double-blind study designed to investigate the efficacy, safety and PK of a single dose of COVI-DROPS or matched placebo in outpatient adults who have tested positive for COVID-19 and are either asymptomatic or have mild symptoms.

Subjects will be randomized 2:2:1 to receive a single dose of COVI-DROPS 10 mg, COVI-DROPS 20 mg or matched placebo in a double-blind manner. Investigational product (COVI-DROPS or matched placebo) will be administered once as two separate 0.5 mL instillations (0.5 mL up each nostril). Subjects will be followed to Day 60.

Eligibility Criteria:
Inclusion Criteria:

* Positive for COVID-19 with any locally approved RT-PCR within 7 days of planned treatment.
* Either have no COVID-19 symptoms (asymptomatic) or mild illness/symptoms
* Must be willing and able to comply with all planned study procedures and be available for all in-person and telephonic study visits and follow-up as required per protocol
* Subject must have provided written informed consent
* Willing to follow contraception guidelines

Exclusion Criteria:

* Moderate or severe illness/symptoms or rapidly progressive symptoms which are likely to progress such that a hospitalization is imminent (within 24-48 hours)
* Any medical condition that, in the Investigator's opinion, could adversely impact subject safety or key objectives of the study, including any intranasal pathology, or clinically significant laboratory abnormalities, or active clinical disease process
* Documented acute infection other thand COVID-19
* Pregnant or lactating women who are breast feeding or planning to during the study
* Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
Mind-Body Skills Groups for Incarcerated Men and Women

The goal of this study is to learn about the effectiveness of a Mind-Body Skills Group program for incarcerated participants.The main questions is aims to answer are:

1. Do the mind-body skills groups increase resilience?
2. Do the mind-body skills groups decrease depression, anxiety and/or stress?
3. Do the mind-body skills groups increase participants' belief that they have improved coping skills?
4. Do the mind-body skills groups increase a sense of meaning in life?
5. Do the mind-body skills groups increase a sense of life purpose?
6. Do the mind-body skills groups increase self-esteem in women?
7. Do the mind-body skills groups decrease aggressive responses in men?


Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria for this study will be English-speaking incarcerated individuals at the Indiana Women's Prison and and at the Plainfield Correctional Facility.

Exclusion Criteria:

1. Having any of the following before the study is completed:

1. a sentence that will end,
2. a scheduled change in security level to a minimum-security prison or,
3. a scheduled work release;

Or 2. Having conduct problems and/or emotional or mental instability that prevents safe and effective participation in the mind-body medicine training program
Micardis® in Patients With Essential Hypertension

The aim of this observational study was to supplement the data on efficacy, safety, and tolerability of telmisartan under daily conditions in hospitals


Eligibility Criteria:
Inclusion Criteria:

* Patients with essential hypertension
* Minimum age of 18 years

Exclusion Criteria: Not applicable
Aflibercept Injection for Proliferative Diabetic Retinopathy

To evaluate the ocular and systemic safety of intravitreal aflibercept injection in patients undergoing Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy.

Patients who need Pars Plana Vitrectomy surgery, and agree to participate in this study will receive an injection of 2.0mg aflibercept 4 to 6 days before Vitrectomy surgery. Half of these patients will be randomized to receive another injection of 2.0mg aflibercept immediately after their surgery. Postoperative patient visits in this study will be at 1 day, and at weeks 1, 4, 16 and 24, and at any other times as deemed necessary by the Investigator.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 18 years
* Diagnosed with proliferative diabetic retinopathy (PDR) requiring pars plana vitrectomy (PPV)
* Best corrected visual acuity in the study eye between 20/40 to light perception (LP) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart

Exclusion Criteria:

* Pregnancy (positive urine pregnancy test) or lactation
* Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an intrauterine device (IUD), or contraceptive hormone implant or patch.
* Participation in a study of an investigational drug or device within the past 30 days prior to enrolling in the study
* For previously treated subjects -
* Prior treatment with anti-vascular endothelial growth factor (anti-VEGF) therapy in the study eye within 28 days of Screening
* Prior treatment with triamcinolone in the study eye within 6 months of Screening.
* Prior treatment with dexamethasone in the study eye within 30 days of Screening
* Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Baseline
* History of vitrectomy surgery, submacular surgery, or other surgical intervention for PDR in the study eye
* Active intraocular inflammation (grade trace or above) in the study eye
* History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
* Uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 30 mmHg despite treatment with anti-glaucoma medication)
* History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 6 months of study enrollment.
* History of allergy to fluorescein, indocyanine green (ICG) or iodine, not amenable to treatment
* Presence of macular traction
* Uncontrolled hypertension (e.g., 120/200 mmHg) prior to surgery (PPV)
* Concomitant use of any systemic anti-VEGF therapy
Effectiveness of an EMDR Intervention for Perinatal Loss

The investigators objectives is to assess the effectiveness of Eye Movement Desensitization and Reprocessing - recent traumatic episode (EMDR-RTE) as a preventive intervention for Posttraumatic Stress Disorder (PTSD) symptoms after perinatal loss.

The hypothesis is that EMDR-RTE treatment may prevent post-traumatic and depressive symptoms in women who suffered perinatal loss.

Perinatal loss is a general term that refers to a loss from conception to one month postpartum. It is a grief that is still socially unauthorized, however, it is a situation with significant traumatic potential. However, there are no studies evaluating the effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) for the prevention or treatment of perinatal loss. We propose an one-site, open label, randomized controlled trial with the aim of assessing the effectiveness of EMDR recent traumatic episode (EMDR-RTE) as a preventive intervention for PTSD symptoms after perinatal loss. A total of 40 women who have suffered a perinatal loss from the Maternal-Fetal Medicine Service of a tertiary university hospital will be recruited. Women will be randomized to EMDR-RTE or treatment as usual (TAU). Researchers will compare EMDR-RTE and TAU to see if women receiving EMDR-RTE treatment had lower levels of post-traumatic and depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

* be over 18 years old
* agree to participate and sign the informed consent
* request psychological treatment

Exclusion Criteria:

* active substance use disorder
* cognitive disability
* language barrier
MIHS Emergency Department CPR Quality Improvement Project

The investigators will quantify the quality of chest compressions provided in the Emergency Department and determine whether the quality of chest compressions is related to patient outcome. The quality of chest compressions and patient outcomes will be assessed both before and after the introduction of audiovisual feedback in real time.

The Emergency Department will be using E-series unit manufactured by ZOLL Medical Group (Chelmsford, MA). These units are equipped with an accelerometer-based system that allows for measurement of chest compression depth and rate. These units are also equipped with RealCPRHelp, and FDA-approved technology that provides real-time audiovisual feedback to providers on the quality of chest compressions.

In the first phase of the project, the ED providers will utilize the E-series units to treat all patients requiring chest compressions.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older

Exclusion Criteria:

* less than 18 years old
Iterative PICC Placement Versus Long Term Device

Peripherally Inserted Central Catheter (PICC) and port-a-cath (PAC) are the most commonly medical devices used for the administration of chemotherapy.

Placement of these devices via central venous access is sometimes responsible for complications.

The incidence of these complications is correlated with the device holding time.

A strategy of iterative PICC placement could significantly reduce these complications.


Eligibility Criteria:
Inclusion Criteria:

* Women older than 18 years old;
* Breast cancer diagnosis histologically proven , for any histological subtypes;
* 4 or 6 indication of neoadjuvant or adjuvant chemotherapy; according to hormonal status and HER2 of the tumors, the patient may be treated concomitantly with hormone therapy and / or trastuzumab; Nota Bene: treatment protocol adopted will imperatively be administered in 3-week cycles.
* Central venous access indication;
* Ability to understand and willingness to comply with the study monitoring;
* Affiliated to the French social security system;
* Informed Consent dated and signed, indicating that the patient has been informed of all pertinent aspects of the study before inclusion.

Exclusion Criteria:

* Any contraindication for placement of a central venous catheter ( hemostasis disorders , active infection treated with antibiotics , ...);
* Patient who can't stop anti -vitamin K treatment ( AVK ) ( a relay by Heparin Low Molecular Weight (LMWH) is possible);
* History of central access, regardless of the indication;
* Any active disease other than cancer pathology , requiring repeated administration of intravenous therapy ;
* Patient deprived of liberty;
* Not monitoring for social, geographical, psychological or family reason.
The Effect of Early Versus Standard Central Line Removal on Growth of Very Low Birth Weight Premature Infants

This study compares two different regimens of a central line removal in respect to weight at 36 weeks postmenstrual age in very low birth weight (VLBW) preterm infants. Half of participants will have a central line removed at ≥100 ml/kg/d, while the other half will have a central line removed at ≥ 140 ml/kg/day.

Eligible infants will be randomized in equal proportions between two groups. In the first group (group A - early central line removal) central line will be removed at the time the infant reaches 100 ml/kg/d of enteral intake. In the second group (group B - standard central line removal) central line will be removed at the time the infant reaches 140 ml/kg/d of enteral intake (full enteral intake). Central lines will be removed after 3 well tolerated consecutive feedings (assessed by the physician) with no contraindications for central line removal present:

* necessity of administration of drugs that must be given via central venous access,
* necessity of administration of drugs that must be given intravenously along with difficulties to secure peripheral venous access,
* necessity of prolonged (\> 7 days) administration of drugs that must be given intravenously,
* necessity to continue parenteral nutrition along with difficulties to secure peripheral venous access.

Assessment of feedings tolerance will be at discretion of the physician taking care for the infant. After central line removal, infants in group A will continue to receive parenteral nutrition via peripheral venous access at the discretion of the physician taking care for the infant. The solution used to continue parenteral nutrition via peripheral venous access will contain at maximum 2,5% amino acids, 10% glucose and no calcium or phosphate preparations to ensure fluid's osmolality will not exceed 900 mOsm/l and the solution will be well tolerated when administered via peripheral vein.

Parenteral nutrition will be prescribed according to the local protocol. Enteral nutrition will be initiated during the first days of life and advanced gradually at the discretion of the neonatologist.

Eligibility Criteria:
Inclusion Criteria:

1. Birth weight ≤ 1500 g (very low birth weight).
2. Birth weight ≥ 3rd percentile at a given gestational age.
3. Central line inserted (PICC or UVC).
4. Oral intake not exceeding 100 ml/kg/d at randomization.
5. Lack of congenital illness or malformation that may affect growth.
6. Signed parental consent.

Exclusion Criteria:

1. Birth weight \> 1500 g.
2. Birth weight \< 3rd percentile at a given gestational age.
3. The absence of a central line.
4. Oral intake ≥100 ml/kg/d at randomization.
5. Congenital illness or malformation that may affect growth.
6. Lack of informed consent.
7. Participation in other intervention (investigational) trials, that may affect the primary outcome.
The Effect of Gardening Activities on Anxiety and Psychosocial Symptoms of Hospitalized Children

The experience of hospitalization in childhood can often lead to traumatic consequences. Various practices (play, art therapy, music therapy, etc.) are used to help children cope with this process. In recent years, attention has been drawn to nature-based approaches in addition to existing practices. Within the scope of this approach, this study was planned in a parallel group (experimental-control) randomized controlled experimental design to determine the effect of garden activities on anxiety levels and psychosocial symptoms of hospitalized children aged 6-12 years. Hypotheses of the study H1: The gardening activities program applied to hospitalized children; H1a: There is an effect on children's anxiety. H1b: There is an effect on psychosocial symptoms of children. In this direction, the population of the study will consist of children between the ages of 6-12 in the children's ward of University Research and Application Hospital. The sample size determined as a result of G\*power analysis was found as control (18) and intervention (18). The research will be conducted between September 2024 and June 2025. 'Child Descriptive Information Form', "Child Follow-up Form", "Child Anxiety Scale-Conditioning" and "Psychosocial Symptoms Diagnostic Scale for Hospitalized Children" will be used for data collection. The data collection process consists of three stages: pre-intervention period, intervention period and post-intervention period. Children in the intervention group will have three sessions of gardening activities within the scope of the 'Gardening Activities Program' during their hospitalization. Children in the control group will receive services within the scope of the routine treatment and nursing care protocol of the clinic during hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* The age of the children is between 6-12 years old
* Hospitalization due to an acute medical diagnosis
* Hospitalization for at least 3 days
* Approval of the child's participation in the session by the responsible doctor
* The child is conscious and fully orientated
* Voluntariness of the child and parent to participate in the study

Exclusion Criteria:

* Hospitalization for more than 7 days
* No previous hospitalization experience
* High-risk drug use
* Having a chronic disease that suppresses the immune system
* Having a special condition that prevents him/her from participating in garden activities (physical, mental disability)
* Having skin conditions that prevent them from participating in garden activities
* Plant allergy
Preoperative Imaging in Retroperitoneal Sarcoma

This is a prospective observational study in which patients with untreated retroperitoneal sarcoma will have Magnetic Resonance Imaging (MRI) prior to surgery. In addition, patients who will be undergoing pre-operative radiotherapy will have an additional MRI scan at two weeks post radiotherapy. For both groups, the magnetic resonance images will be correlated with tumour pathology.

The study hypothesis is that Magnetic Resonance Imaging will provide a more accurate assessment of tumour volume and local staging than CT and will identify areas of altered oxygenation, cellularity and perfusion which change in response to radiotherapy before tumour shrinkage occurs.


Eligibility Criteria:
Inclusion Criteria:

* Patients with retroperitoneal sarcomas planned for surgical resection +/- preoperative radiotherapy.

Exclusion Criteria:

* MRI incompatible metal implants
* claustrophobia
A Trial Comparing the Pharmacokinetic Properties of Fast-acting Insulin Aspart Between Children, Adolescents and Adults With Type 1 Diabetes

The study is done to compare how faster aspart is taken up, broken down and removed from the body between different age groups (children \[6-11 years\], adolescents \[12-17 years\] and adults \[18-64 years\]) who have diabetes. The blood sugar (glucose) lowering effect of faster aspart will also be investigated after consuming a meal replacement drink. The effects of faster aspart will be compared to the effects of NovoRapid®.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 6-64 years (both inclusive) at the time of signing informed consent
* Diagnosed with type 1 diabetes greater than or equal to 12 months prior to the day of screening
* Body mass index for children and adolescents (male and female) between the 3rd and 97th BMI percentile and for adults less than or equal to 28.0 kg/sqm

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
* Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
Insomnia and Wake up and Recovery From Anesthesia

18-55 years old 100 patients, who are planned to undergo for planned ureteroscopy will be participated in the study. In the preoperative room patients will be asked to participate to the study. If they accept 4 item Jenkins-Sleep Questionaire will be asked to them.Patients will be divided to two groups , with or without insomnia according to their answers to the questionaire. General anesthesia will be performed to all patients. At the end of operation anesthesia time,operation time, time of eye opening, time of transfer to the recovery room will be recorded in the operating room. Pain scores and recovery scores will be evaluated in the recovery room.

18-55 years old 100 patients with American Society of Anesthesiology (ASA) physical status I-II,who are planned to undergo for elective ureteroscopy will be participated in this study.In the preoperative room patients will be asked to participate to the study and will be asked to answer the 4-item Jenkins-Sleep Questionaire.If they accept to participate, written informed consent will be taken from the patients. According to their answers to the questionaire , patients will be divided into two groups :those with or without insomnia.General anesthesia will be performed to all patients. After anesthesia induction with propofol 2mg/kg and rocuronium 0.6 mg/kg, patients will be ıntubated and mechanically ventilated. Maintenance of anesthesia will be achieved with 4-6 % desflurane in nitrous oxide/ oxygen (50%/50%) concentrations with the flow 5L/min. Tramadol 1 mg/kg and metoclopramid 1 ampul will be administered intravenously after intubation. Hemodynamic parameters( systolic blood pressure, diastolic blood pressure, heart rate and peripheral oxygen saturation), end tidal carbon dioxide values, the concentrations of inspired and exhaled desflurane will be recorded on the surgery start time and on the 5th, 15th,25th,35th,45th,60 th minutes of surgery. At the end of operation ,neuromuscular blockage will be reversed with neostigmine (0,05 mg/kg)and atropine sulphate 0,015 mg/kg i.v. Anesthesia time, surgery time, time of eye opening,time of transfer to the recovery room will be recorded in the operating room. In the recovery room pain score will be evaluated with Visual Analogue Scale. Modified Aldrete Recovery Score will be used for evaluating recovery.

Eligibility Criteria:
Inclusion Criteria:

* 18- 55 years
* ASA 1-2 patients
* Patients undergoing elective ureteroscopy

Exclusion Criteria:

* Renal failure
* Obstructive Sleep Apnea Syndrome,
* Thyroid dysfunction
* Neurologic and physiatric dysfunctions,
* Morbid obesity
* Anticonvulsant, antidepressant, anxiolytic drugs usage