cyrilzakka/clinical-trials huggingface dataset:
intrathecaم Ketamine, Morphine and Both for Lower Abdominal Cancer Surgery Pain

this study investigates the analgesic efficacy and other possible effects of ketamine, morphine, and both together when administered intrathecally for control of postoperative pain following lower abdominal cancer surgeries.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesia (ASA) I-III patients.
* aged 30-50 years.
* scheduled for major abdominal cancer surgery.

Exclusion Criteria:

* Patients with a known allergy to the study drugs.
* significant cardiac, respiratory, renal or hepatic disease.
* coagulation disorders.
* infection at or near the site of intrathecal injection.
* drug or alcohol abuse.
* BMI \> 30 kg/m2.
* psychiatric illnesses that may interfere with perception and assessment of pain.
Use of Fractional CO2 Laser Versus Erbium:YAG Laser for the Treatment of GSM in Patients Using Aromatase Inhibitors

To study the efficacy and safety of intravaginal CO2 laser versus intravaginal Er:YAG laser and sham application in alleviating genitourinary symptoms in patients receiving an aromatase inhibitor as adjuvant treatment of breast cancer

The objective is to compare microablative fractional CO2 laser (CO2 laser) (SmartXide2 V2 LR, Monalisa Touch; DEKA, Florence, Italy) and non-ablative photothermal Erbium:YAG laser (Er:YAG laser) (Fotona Smooth™ XS; Fotona, Ljubljana, Slovenia) - with sham vaginal applications for treatment of vaginal dryness as the leading symptom in breast cancer patients with iatrogenic menopause and treated with an AI.

Eligibility Criteria:
Inclusion Criteria:

Recruited participants will meet all of these criteria:

* a history of breast cancer
* premenopausal at diagnosis of breast cancer
* using AI as an adjuvant treatment
* moderate to severe symptoms of GSM (VAS ≥ 4/10)
* currently menopausal, which can be either biochemical menopause as confirmed after chemotherapy, surgical or medicinally induced (GnRH analogues for the duration of the trial)

Exclusion Criteria:

* Not willing to abstain from vaginal intercourse for 1 week following laser therapy
* Use of non-hormonal vaginal preparations within the last 6 weeks before inclusion
* Use of hormonal therapy within 6 months prior to inclusion (systemic or local)
* Acute urinary or genital tract infections
* A history of genital fistula, a thin rectovaginal septum as determined by the investigator, or history of fourth degree laceration
* Prolapse ≥ grade 2 according to the Pelvic Organ Prolapse Quantification System
* Previous vaginal mesh implantation
* Abnormal result in the last cervical smear (maximum 36 month before enrollment)
* Active cancer treatment (radiotherapy or chemotherapy) ongoing or planned prior to the measurement of the primary outcome (6 months after inclusion, 3 months after last laser)
* Vaginal stenosis that does not allow the placement of the laser probe
* Any condition that could interfere with study compliance
Russia/Ukraine Suppression of Ovarian Activity Study

The purpose of this study is to look into the effectiveness of a new investigational medication applied as a transdermal patch. The patch is applied on the skin with study medication that is absorbed through the skin suppressing ovarian activity and therefore preventing an egg from leaving an ovary (ovulation). The study will look into the study drug's safety and how well it is tolerated and its absorption, breakdown and elimination in the body. It describes how the body affects a specific drug after administration.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects requesting contraception
* Aged 18 to 35 years (inclusive); smokers must not be older than 30 years
* Normal or clinically insignificant cervical smear not requiring further follow-up
* History of regular cyclic menstrual periods
* Willingness to use nonhormonal methods of contraception during the entire study
* Proven ovulation upon completion of the pretreatment cycle

Exclusion Criteria:

* Pregnancy or lactation
* Obesity (body mass index \[BMI\] \> 30.0 kg/m2)
* Significant skin reaction to transdermal preparations or sensitivity to surgical/medical tape
* Any disease or condition that may worsen under hormonal treatment
* Use of hormonal contraception other than study medication during the study
Contemporary Modalities in Treatment of Heart Failure

The Contemporary Modalities In Treatment of Heart Failure Registry (COMMIT-HF) is an observational study on an all-comer systolic heart failure population hospitalized in a highly specialized cardiovascular center. The aim of the study is to assess the clinical characteristics, treatment modalities and prognosis in this population.

The Contemporary Modalities In Treatment of Heart Failure Registry (COMMIT-HF) is a single-center observational study that is underway in the 3rd Chair and Department of Cardiology of Silesian Center for Heart Diseases in Zabrze, Poland. Data collection is patient-based (not event-based).

The main objective of the COMMIT-HF Registry is to clarify the overall clinical characteristics of systolic heart failure patients, their demographics and clinical profile, current management, in-hospital outcomes and long-term follow-up, with regard to the administered treatment.

The study population is formed by all-comer patients hospitalized in cardiology wards and intensive cardiac care units with a diagnosis of systolic heart failure. For the purpose of this study heart failure is defined as a set of symptoms resulting from myocardial systolic function impairment, confirmed in resting transthoracic echocardiography with left ventricular ejection fraction (LVEF) ≤35%. Patients with acute coronary syndromes are excluded from the analysis.

Complete patient demographics; medical history, complete hospitalization data (diagnostic and therapeutic) and in-hospital results are collected in an electronic form by the attending physician. The patients are under constant follow-up for all cause mortality and major adverse events.

Eligibility Criteria:
Inclusion Criteria:

* symptom based diagnosis of heart failure
* echocardiographically confirmed impaired left ventricular ejection fraction ≤35%.

Exclusion Criteria:

* acute coronary syndrome on admission
* ≥ 18 years old
Hemodynamic Effect of Nasal High-flow in Patients Suspected or Followed for a Precapillary Pulmonary Hypertension

In this study, the investigators aim to describe the hemodynamic consequences of nasal high-flow measured during right heart catheterization and echocardiography. The research hypothesis is that nasal high-flow would increase cardiac output in patients with pulmonary hypertension. The concomitant echocardiography will allow to describe its sensibility to detect cardiovascular consequences of nasal high-flow.


Eligibility Criteria:
Inclusion Criteria:

- patient addressed for right heart catheterization for pulmonary hypertension suspicion or follow-up.

Exclusion Criteria:

* necessity of FiO2 \>21% during right heart catheterization
* intracardiac shunt
* grade 4 tricuspid insufficiency
* complete arrhythmia due to atrial fibrillation
* Pregnant or breastfeeding women or women of childbearing age without an effective method of contraception
* protected adult patient (tutorship or curatorship)
* patient deprived of liberty by court or administrative decision
* refusal of patient participation or consent
* patient for whom the measurement of pulmonary arterial pressures during right heart catheterization is impossible
* patient for whom, during the etiological assessment of pulmonary hypertension, the diagnosis of precapillary pulmonary hypertension cannot be confirmed and classified in groups 1, 3 or 4.
Apidra Children & Adolescents Study

Primary Objective:

Evaluate the percentage of patients achieving glycosylated hemoglobin (HbA1c) level \< 8% (in patients of 6-12 years old) and HbA1c level \< 7.5% (in patients of 13-17 year old) at 6 and 12 months of treatment

Secondary Objectives:

Change in HbA1c level at 6 and 12 months of treatment Monthly rate of hypoglycaemia/per patient from the baseline to the end of the study Change in daily dose of glargine and glulisine at 6 and 12 months of treatment.


Eligibility Criteria:
Inclusion criteria:

* ChildrenAdolescents with Type 1 diabetes Mellitus l(T1DM) onger than 1 year duration
* Age 6 -17 y.o.
* With 8%\<HbA1c \<10%
* Treated with insulin glargine and any rapid insulin
* Ability to perform a self blood-glucose monitoring (SBGM)
* Signed Informed consent.

Exclusion criteria:

* Diabetes Mellitus type 2
* ChildrenAdolescents with Type 1 diabetes Mellitus previously treated with Apidra
* Hypersensitivity to Insulin glulisine
* Pregnant or lactation women
* Gestational diabetes mellitus
* Treatment with systemic corticosteroids in the 1 month prior to study entry
* T1DM complications: such as already existing active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Safety, Efficacy, and Pharmacokinetic Profile of DNB-001 in Subjects With Elevated Intraocular Pressure

A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase 1I Study to Investigate the Safety, Efficacy, and Pharmacokinetic Profile of Twice-Daily DNB-001 in Previously Untreated Patients with intraocular Hypertension

To evaluate the efficacy of four dosages of mg DNB-001 administered twice daily (bid) per os (p.o.) as an anti-ocular hypertensive agent, compared with placebo administered bid po, for 28 days, in patients with ocular hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, at least 18 years old, in general good health, not presently treated for elevated intraocular pressure (IOP), with best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score equivalent to a Snellen score of 20/50 or better in each eye and lOP of 21 to 29 mm Hg at baseline.

Exclusion Criteria:

* Use of intraocular pressure lowering medication within the past 3 months or any history of ocular surgery for glaucoma
* Evidence of potential angle closure by gonioscopy
* Abnormal optic disc or visual field consistent with glaucoma
* Use of topical ocular medications during the study and any evidence of systemic disease that might interfere with the conduct of the study.
ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours

Adcendo ApS is conducting a phase 1 study of an investigational drug called ADCE-T02 (previously known as AMT-754), a tissue factor targeted antibody-drug conjugate which may be used in the future as a possible treatment for advanced solid tumors.

The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the recommended dose and the safety and tolerability of ADCE-T02 when given as a single therapy over a range of different dose levels.


Eligibility Criteria:
Key Inclusion Criteria:

1. Patients must have pathologically confirmed unresectable advanced solid tumor.
2. Patients who have undergone at least one systemic therapy and have progressive disease
3. Patients must have at least one measurable lesion as per RECIST version 1.1.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
5. Life expectancy ≥ 3 months.
6. Patients must have adequate organ function as indicated by laboratory values
7. Women of childbearing potential (WCBP), defined as sexually mature women who have not undergone surgical sterilization or who have not been naturally postmenopausal for at least 12 consecutive months must agree to use two effective contraceptive methods while on study treatment and for at least 7 months after the last dose of ADCE T02.
8. Male patients must agree to use condoms, even if they have had a successful vasectomy, while on study treatment and for at least 4 months after the last dose of ADCE T02.

Key Exclusion Criteria:

1. Prior treatment with any agent targeting Tissue Factor
2. Central nervous system (CNS) metastasis.
3. Active ocular surface disease or a history of cicatricial conjunctivitis or inflammatory conditions that predispose to cicatrizing conjunctivitis, mucus pemphigoid or penetrating ocular transplants.
4. Persistent toxicities from previous systemic anti-neoplastic treatments
5. Known past or current coagulation defects leading to an increased risk of bleeding
6. Significant cardiac disease; recent myocardial infarction, acute coronary syndromes, congestive heart failure , uncontrolled hypertension, uncontrolled cardiac arrhythmias
7. History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis
8. Prior history of malignancy other than inclusion diagnosis within five years prior to first dose of ADCE T02.
Effect Mechanism of Custom-made Foot Orthoses in Patients With Chronic Low Back Pain

Excessive foot pronation has been recognized as being linked to chronic low back pain (CLBP). The use of compensating custom-made foot orthoses has not been entirely explored as an effective therapy for CLBP Objective: to investigate the effects of wearing custom made foot orthoses compared to placebo orthoses in patients with pronated feet and chronic low back pain (CLBP).

Excessive foot pronation has been recognized as being linked to CLBP. Foot hyperpronation may cause malalignment of the lower extremity.There is a wide variety of treatments for CLBP, and it is suggested that excessive pronation of the foot has been linked to CLBP.The use of compensating custom-made foot orthoses has not been entirely explored as an effective therapy for CLBP.

Customized foot orthoses alter the position of the foot during weight-bearing. The goal is to eliminate compensation of the foot due to structural deformity or misalignment and redistribute abnormal plantar pressures.Custom-made foot orthoses may contribute to improving chronic low back pain. This question represents an important benefit for patients and for the public health system by reducing expensive treatments, such as surgery or long periods of rehabilitation

Eligibility Criteria:
Inclusion Criteria:

* Males and females between 18 and 65 years old
* Presence of CLBP
* Foot Posture Index pronated in one or both feet (henceforth, FPI) ≥ +6

Exclusion Criteria:

* Serious illness
* Current participation in another research study
* Pregnancy
* Previous back or foot surgery
* Current treatment of foot pathology or back, and leg length discrepancy \> 5 mm
Effect of Passive Leg Raising for Fluid Responsiveness

Changes in volumetric hemodynamic parameters and fluid overload (Cardiac Index,Stroke Volume, Thoracic Fluid Content, Systemic Vascular Resistance) were measured using a impedance cardiography (ICG) (CardioScreen 1000 - Haemodynamic Measurement System, Medis. GmbH Ilmenau) while lifting the leg at different angles. The measurement lasted 12 minutes.


Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* no clinical cardiovascular disease during the 6 months proceeding entry

Exclusion Criteria:

* not meet above criteria
* episode of illness (for example: infection)
* pregnancy
A First-in-Human PoC Study With BEN2293 in Patients With Mild to Moderate Atopic Dermatitis

A randomised, adaptive design, double-blind, placebo-controlled, first-in-human, two-part study to investigate the safety, tolerability, PK and preliminary efficacy of multiple topical doses of BEN2293 in patients with mild to moderate AD.

This Protocol will be adaptive and designed to enable knowledge gained from the previous cohort to be applied to subsequent cohorts. Changes made will be within the boundaries of the adaptive elements with clear control mechanisms and guidance for staying within these boundaries.

Part A is a randomised, double-blind, placebo-controlled, sequential group study to investigate ascending multiple topical doses of BEN2293 in patients with mild to moderate AD. Patients will participate in only one cohort.

Part B is a randomised, double-blind, placebo-controlled, parallel group study to investigate up to two dose regimens of topical doses of BEN2293 administered for a maximum of 28 days in patients with mild to moderate AD.

Eligibility Criteria:
Inclusion Criteria:

* Males and females with mild to moderate AD (based on vIGA) free from other clinically significant illness or disease that may adversely affect the safety of the patient or the integrity of the study as determined by medical history, physical examination, safety laboratory and other assessments.
* History of AD for at least 6 months diagnosed by a dermatologist or GP.
* Previous or current successful treatment with topical corticosteroids.
* A vIGA score of 2 (mild) to 3 (moderate) at both Screening and Day -1 (Part A) and at Screening, Day-3 and Day 1 (Part B).

Exclusion Criteria:

* Atopic dermatitis of such severity that the patient could not comply with the demands of the study and/or the patient is not a suitable candidate for a placebo controlled study, as per Investigator's discretion.
* Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IMP application sites.
* Patients who have AD lesions affecting \>3% untreatable areas (face, scalp, genitals, palms of hands or soles of feet).
* Have concomitant skin disease or infection (e.g., acne, impetigo) or presence of skin comorbidities in the study area to be dosed that may interfere with study assessments.
* Patients who are excessively hirsute in areas of skin to be dosed with study ointment.
* Patients who are unwilling to stop hair removal by any means (including shaving, waxing or depilatory creams) to skin areas to be dosed with study ointment for 2 weeks prior to Day -1 and throughout the duration of the study.
* Clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations as judged by the Investigator (including \[but not limited to\], neurological, psychiatric, endocrine, cardiovascular, gastrointestinal, hepatic, or renal disorder).
* The patient has participated in a clinical study and has received a medication or a new chemical entity within 3 months prior to Day 1.
Obtaining Undifferentiated Cells From Testis Biopsy

The purpose of this study is to isolate and culture stem cell from adult human testicular biopsies for future transplantation in fertility preservation.

Testicular biopsies were obtained from azoospermic patients as part of their diagnosis and work-up after obtaining a signed informed consent. A portion of each sample was mechanically dissected in PBS with 1% Pen/Strep. For enzymatic digestion samples were incubated with 0.5g/ml Collagenase type 1A for 20min and TripLE Select for 15min at 37ºC on a shaker and then filtered with 30µm and centrifuged at 1,000rpm. The pellets were seeded and incubated in embryonic stem cell media (hESC) with glial cell line-derived neurotrophic factor (GDNF 4ng/mL) for 5-7 days at 37ºC (1st culture). To identify and isolate SSCs they were marked with CD49f antibody and FACS sorted. Positive cells were cultured in gelatine plates containing hESC media with leukaemia inhibitory factor (LIF1000U/mL) (2nd culture).

Eligibility Criteria:
Inclusion Criteria:

-azoospermic patients
Characterization and Prediction of Atrial Fibrillation-caused Adverse Events After Hospital Discharge for Cardiac Surgery

The purpose of the research is to identify the frequency and severity of adverse events related to atrial fibrillation that occur after discharge from hospital where the patient underwent cardiac surgery.

The Specific Aims of the proposed study are to:

1. Identify the predictors of postoperative atrial fibrillation after discharge from hospital.
2. Identify the frequency of readmission to hospital, or other resource use such as Emergency Department or outpatient visit, for the treatment or prophylaxis of postoperative AF and consequent stroke or bleeding outcomes.
3. Identify the risks for stroke, death and other morbidity in patients after cardiac surgery and the effect of postoperative AF upon subsequent stroke or bleeding outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent cardiac surgery in Massachusetts between 2012 - 2016

Exclusion Criteria:

* surgical procedures that do not include coronary artery bypass graft surgery, aortic valve surgery or mitral valve surgery;
* surgical procedures that include MAZE surgery, or pulmonary vein isolation, ventricular assist device, heart transplantation, congenital heart surgery, bacterial endocarditis, cardiac trauma, cardiac tumor, ventricular septal defect repair, left ventricular aneurysm repair, pulmonary thromboendarterectomy, sub-aortic stenosis resection or surgical ventricular restoration;
* surgical procedures on patients that have undergone MAZE surgery, AF ablation procedures, pulmonary vein isolation or left atrial appendage resection or ablation (such as Watchman devices).
Study of Hyperkyphosis, Exercise and Function-SHEAF

We propose to conduct a randomized, controlled trial among 100 men and women aged 60 or older with hyperkyphosis to an exercise intervention that includes kyphosis-specific spinal muscle strengthening exercises compared to a usual care control group. The study will be conducted in five waves,with 10 participants in the exercise intervention and 10 participants in the control group in each wave.

The experimental interventions will be provided in small groups meeting three sessions per week for 6 months. At baseline and 6 months after the intervention, we will measure kyphosis, physical function, spine muscle strength and density, and quality of life. We will assess the effect of the intervention on the co-primary outcomes of kyphosis, modified Physical Performance Test (PPT) and gait speed measured as change over 6 months. We will also assess the effect of the intervention on secondary outcomes of physical function and health-related quality of life, measured as change in Timed Up and Go, Timed Loaded Standing, Six-Minute Timed Walk, the Scoliosis Research Society SRS-30, PROMISe Global Health and physical function and PACE questionnaires. Furthermore, we will investigate whether changes in kyphosis, spinal muscle strength and/or density mediate the effect of the intervention on change in physical function. After the 6-month intervention, both groups will continue their usual activity and we will assess the durability of the effects of the intervention at 1-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age 60 years and older, kyphosis angle \>= 40 degrees measured by kyphometer, medical approval from study physician and primary care provider to participate in exercise intervention

Exclusion Criteria:

* Gait speed \<0.6 meters/sec, inability to rise from a chair with arms crossed at chest, painful vertebral fractures in the past 3 months, 3 or more falls in the past year, advanced disability or end-stage disease, major psychiatric illness, cognitive impairment, alcohol, drug abuse, or narcotic pain medications, uncontrolled hypertension, peripheral neuropathy associated with type I diabetes, chest pain, myocardial infarction, or cardiac surgery within the previous 6 months, diagnosed vestibular or neurologic disorder, total hip or knee replacement or hip fracture within previous 6 months, oral glucocorticoid medications for ≥ 3 months the past year, no active movement in thoracic spine, unable to execute exercise safety tests, failure to comply with run-in procedures: poor attendance, or use of actigraph, non-English speaking