cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate THR-317 and Ranibizumab Combination Treatment for Diabetic Macular Oedema (DME)

This study is conducted to evaluate the safety of intravitreal THR-317 administered in combination with ranibizumab, and to assess the efficacy of the combination treatment in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST), in subjects with central-involved diabetic macular oedema (CI-DME).


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years or older
* Type 1 or type 2 Diabetes Mellitus
* CI-DME with central subfield thickness of ≥ 320μm on Spectralis® SD-OCT or ≥ 305μm on non Spectralis SD-OCT, in the study eye
* Anti-vascular endothelial growth factor (anti-VEGF) treatment naïve study eye, or poor or no response to prior treatment with ranibizumab in the study eye
* Reduced vision primarily due to DME, with BCVA ≤ 72 and ≥ 23 ETDRS letter score (≤ 20/40 and ≥ 20/320 Snellen equivalent) in the study eye
* Non-proliferative diabetic retinopathy of any stage in the study eye
* Written informed consent obtained from the subject prior to screening procedures

Exclusion Criteria:

* Concurrent disease in the study eye, other than CI-DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results
* Previous confounding treatments / procedures, or their planned / expected use during the study period for up to 30 days after the last administration of study treatment
* Any active ocular / intraocular infection or inflammation in either eye
* Aphakic study eye
* Poorly controlled Diabetes Mellitus
* Uncontrolled hypertension
* Pregnant or lactating female, or female of child-bearing potential not utilising an adequate form of contraception, or male of reproductive potential not utilising contraception
Fluid Restriction in Heart Failure Versus Liberal Fluid Uptake

Multi-centre open-label 1:1 randomized clinical trial in chronic heart failure patients on the effect of fluid restriction versus liberal fluid intake on quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic HF with NYHA class II/III according to the prevailing guidelines \> 6 months prior to randomization (1)
* Adult (age ≥ 18 years)

Exclusion Criteria:

* Reversible cause of HF (thyroid disorders, severe anemia, vitamin deficiencies)
* Hospital admission for HF within 3 months of randomization
* Chronic HF with NYHA class IV
* Hyponatremia at baseline (sodium \<130mmol/l)
* Changes in HF medical therapy in last 14 days prior to randomization
* Estimated Glomerular Filtration Rate (eGFR) of \< 30ml/min/1.73 m2 at baseline
* Scheduled cardiac surgery within 3 months of randomization
* Recent (within 3 months) coronary intervention (PCI or CABG) or implantation of pacemaker device
* Comorbidity for which fluid restriction is advised by a different treating physician (e.g. nephrologist)
* Comorbidity with a life expectancy of less than 6 months
* The treating clinician believes that participation in the domain would not be in the best interests of the patient
* Inability to provide informed consent
Stroke Rehabilitation Outcomes With Supported Treadmill Ambulation Training

This project seeks to overcome the reduced walking capability, poor health status, decreased functional capacity, and sedentary lifestyle of stroke patients. The specific objectives are to compare the effects of regular inpatient stroke rehabilitation to regular rehabilitation combined with STAT after an acute stroke on: a) gait performance; b) functional outcomes; c) oxygen consumption during a seated task; and finally: d) using Brain Motor Control Assessment to obtain neurophysiological characteristics, as possible predictors of rehabilitation outcomes.

Gait training is often delayed during the rehabilitation process because gait is thought to require preparation such as improved strength, balance, and coordination before the initiation of this more complex and demanding activity. We propose a new approach to perform early gait training with acute stroke patients, which consists of Supported Treadmill Ambulation Training (STAT) combined with conventional rehabilitation for achieving functional ambulation.

Hypotheses: This study will test three hypotheses;

1. The STAT group will develop greater gait speed, longer walking endurance, and lower oxygen costs for walking as compared to stroke patients receiving regular rehabilitation care.
2. The STAT group will develop better functional outcomes (Functional Independence Measurement total scores and on the transfers and locomotion subscales) as compared to stroke patients receiving regular rehabilitation care.
3. The STAT group will develop higher submaximal oxygen consumption as measured on a bicycle ergometer test compared to stroke patients receiving regular rehabilitation care.

Specific Objectives and Projected Timetable:

Since stroke patients have reduced walking capability, poor health status, decreased functional capacity, as well as a sedentary lifestyle, the specific objectives of this project are:

1. Compare the effects of regular inpatient stroke rehabilitation to regular stroke rehabilitation combined with STAT after an acute stroke on gait performance;
2. Compare the effects of regular inpatient stroke rehabilitation to regular rehabilitation combined with STAT after an acute stroke on functional outcomes, as defined by the Functional Independence Measure (FIM);
3. Compare the effects of regular inpatient stroke rehabilitation to regular stroke rehabilitation combined with STAT after an acute stroke on the oxygen consumption during a seated exercise task.
4. Explore whether neurophysiological characteristics using the Brain Motor Control Assessment (BMCA) predict rehabilitation outcomes.

Timetable: This 3-year project will compare the outcomes between two strategies of intervention during stroke rehabilitation. Admission, randomization, testing, intervention, reevaluation, and discharge will follow the time frame established by the facility while providing regular rehabilitation care for stroke patients. On average, the stroke rehabilitation process lasts two to three weeks.

Eligibility Criteria:
Recent unilateral stroke patients
A Study to Investigate the Effects of BMS-986278 on Drospirenone and Ethinyl Estradiol Drug Levels in Healthy Female Participants

The purpose of the study is to assess the effects of BMS-986278 on Drospirenone (DRSP) and Ethinyl Estradiol (EE) when administered as a combined oral contraceptive in healthy female participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18.0 and 32.0 kilograms/meter square (kg/m\^2), inclusive.
* Body weight ≥ 45 kg.
* Healthy females, as determined by physical examination and clinical laboratory assessments (including chemistry, hematology, coagulation, and urinalysis) within the normal range at the screening visit and on Day -1, as applicable.

Exclusion Criteria:

* Any significant acute or chronic medical illness.
* Any gastrointestinal (GI) disease or surgery (including cholecystectomy) or other procedures (eg, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. Note: Appendectomy is allowed (12 months prior to screening).
* Any other clinically significant medical, psychiatric, and/or social reason, or other active issues, especially eye issues, as determined by the investigator.

Note: Other protocol-defined inclusion/exclusion criteria apply.
Study to Evaluate the Safety & Tolerability of MRT5005 Administered by Nebulization in Adults With Cystic Fibrosis

This Phase 1/2, first-in-human study will evaluate the safety and tolerability of single and multiple escalating doses of MRT5005 administered by nebulization to the respiratory tract of adult subjects with CF.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CF as defined by both of the following:

  * Two CF disease-causing CFTR mutations in Class I or II (genotype confirmed at the screening visit).
  * Chronic sinopulmonary disease and/or gastrointestinal/nutritional abnormalities consistent with CF disease.
* Clinically stable CF disease, as judged by the investigator.
* FEV1 ≥50% and ≤90% of the predicted normal for age, gender, and height at screening.
* Resting oxygen saturation ≥92% on room air (pulse oximetry).

Exclusion Criteria:

* An acute upper or lower respiratory infection, pulmonary exacerbation, clinically significant episode of hemoptysis or change in chronic respiratory medications (including antibiotics) for CF lung disease within 28 days prior to dosing with investigational product on Day 1.
* Receiving treatment with ivacaftor monotherapy (KALYDECO)
* For all groups except Daily dosing: Receiving treatment with triple combination therapy (TRIKAFTA).
* Subjects with a Class III, IV, or V CFTR gene mutation in at least 1 allele.
* Infection with highly virulent bacteria associated with accelerated decline in pulmonary function and/or decreased survival (e.g., Burkholderia cenocepacia, Burkholderia dolosa, Mycobacterium abscessus).

Treatment with ORKAMBI or SYMDEKO is not an exclusion for this study.
Conventional Laparoscopic Sleeve Gastrectomy Versus Endograb-assisted Single-port Sleeve Gastrectomy

Bariatric surgery has been established as the best treatment for morbid obesity, compared with diet or medical treatment. Laparoscopic approach have improved the results of this surgery in terms of postoperative pain, reduction in the number of complications and hospital stay, as well as better cosmetic results. Conventional laparoscopic technique requires five to seven abdominal incisions to facilitate placement of the multiple trocars. New Single Incision Laparoscopic Surgery (SILS)has been developed as a new technique where only one incision is needed for the introduction of all trocars. Altough this technique can be performed with conventional laparoscopic instruments, new devides have been developed for facilitate this operations by SILS. The investigators think that reducing the number of incision would decrease the postoperative pain and improve cosmetic results in our patients, being a safe and technically feasible intervention supported by these special devices.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index \> 40
* Body Mass Index \> 35 with 2 mayor comorbidities

Exclusion Criteria:

* Severe gastroesophageal reflux
* Esophagitis grade B or higher
* Midline periumbilical incision
* Umbilical hernia \>4cms.
A Study To Assess Absorption Of Study Drug Dacomitinib (PF-00299804), Given As An Oral Tablet Compared To An Intravenous Infusion In Healthy Volunteers

This study aims to determine the proportion of study drug dacomitinib or PF-00299804, that is taken up from the digestive tract into the body when given as an oral tablet compared with that taken up by an intravenous dose.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female (of non-childbearing potential) subjects between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Treatment with an investigational drug within 3 months or 5 half-lives preceding the first dose of study medication, whichever is longer.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* Any known allergies or sensitivity to drug excipients.
The Efficacy, Safety, and Tolerability of Probiotics on the Mood and Cognition of Depressed Patients

This study will be an 8-week open-label pilot study examining subjective and objective changes in mood, anxiety, cognition, and sleep before and after the introduction of a probiotic supplement containing Lactobacillus helveticus and Bifidobacterium longum in 10 treatment-naïve participants diagnosed with major depressive disorder (MDD). In order to examine the full composition of the micro biome, the investigators will also be collecting and analyzing fecal samples as well as blood samples to examine changes in plasma levels of inflammatory markers, 5-HT, and tryptophan in order to look at possible underlying mechanisms of any changes seen.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Major Depressive Disorder (MDD) by Mini International Neuropsychiatric Interview (MINI)
2. Current depressive episode with a MADRS score of ≥ 20
3. Males and females between ages 18 and 65
4. Able to understand and comply with the requirements of the study
5. Provision of written informed consent

Exclusion Criteria:

1. Use of any antidepressant drug
2. Use of any antibiotic drug in the past 4 weeks (may be eligible to participate after a 1-month washout period)
3. Use of any sleep medication in the past 4 weeks (may be eligible to participate after a 1-month washout period)
4. Milk, yeast, or soy allergy
5. History of alcohol or substance abuse in the past 6 months
6. Daily use of probiotic product in the past 2 weeks (may be eligible to participate after a 2-week washout period)
7. Use of any type of laxative
8. Consumption of products fortified in probiotics
9. Severely suicidal
10. Experiencing psychosis or bipolar episode
11. History of epilepsy or uncontrolled seizures
Neoadjuvant Chemotherapy in Locally Advanced Bladder Cancer

To evaluate the efficacy and safety of neoadjuvant gemcitabine and cisplatin (gem/cis) in locally advanced bladder cancer.

Patients with locally advanced transitional cell bladder cancer receive 3 cycles of neoadjuvant gemcitabine/cisplatin before radical cystectomy.

Patients with histologically confirmed clinical stage T2-T4a, N0-2 bladder cancer are going to be included. After CT scan of the thorax and abdomen plus MRI of the pelvis patient receive chemotherapy.

Pathologic response rate will be assessed after surgery by the institutional pathologic review. Safety is going to be assessed according to the National Cancer Institute Common Toxicity Criteria (CTC,version 3.0).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* histologically confirmed stage T2, T3 or T4a urothelial bladder cancer with N0-N2
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* bone marrow reserve (neutrophil count \>1500 cells per μL,platelet count \>100 000 per μL) count
* hepatic function (serum bilirubin \<2,5 times the upper limit of normal, serum aminotransferase ≤2,5 times the upper limit of normal).
* renal function with a creatinine clearance \>60ml/min

Exclusion Criteria:

* metastatic disease
* serious or uncontrolled concurrent medical illness
* pregnancy
* history of other malignancies (with the exception of excised cervical or basal skin or squamous-cell carcinoma)
* non-transitional cell bladder cancer
* creatinine clearance \<60ml/min
Evaluation of the Mental Foramen After Surgery Via Ultrasonography

Objective: This study aims to detect changes in blood flow in the mental foramen after surgery compared to before orthognathic surgery.

Materials and Methods: This study will include a total of 16 patients, aged between 18-60, who were planned for orthognathic surgery due to malocclusion complaints. Patients will be evaluated clinically and radiologically before surgery, 1 week, 1 month, and 3 months after the surgery. Panoramic radiographs will be taken before surgery and 3 months after surgery, and a fractal analysis of the ROI area determined distal to the mental foramen will be performed. Pain will be scored from 1 to 5 using the Pinprick test before surgery, 1 week, 1 month, and 3 months after surgery, while pressure and neurosensitivity will be scored using VAS. Neurosensory evaluation will be performed using two-point discrimination (dividing the area between the lower lip and chin into 9 regions), and left-right discrimination will be checked using the brush test. Blood flow in the mental foramen will be evaluated using ultrasonography.


Eligibility Criteria:
Inclusion Criteria:

1. Patients over 18 years old,
2. Patients who have reached skeletal maturity,
3. Patients under 60 years old,
4. Patients with skeletal Class II malocclusion indicated for orthognathic surgery,
5. Patients with skeletal Class III malocclusion indicated for orthognathic surgery,
6. Those who are willing to participate in the study

Exclusion Criteria:

1. Patients with cleft lip and palate,
2. Patients with craniofacial anomalies,
3. Patients with a systemic disease,
4. Patients under 18 years old,
5. Patients who have not completed their growth and development,
6. Patients over 59 years old,
7. Patients using neurological and psychiatric medications,
8. Patients who have previously undergone surgery or experienced trauma in the mandibular region,
9. Patients with neurosensory dysfunction in the inferior alveolar nerve before surgery,
10. Pregnant individuals or those suspected of being pregnant,
11. Any local or systemic condition that may contraindicate general anesthesia
Improving Cardiac Arrest Diagnostic Accuracy of Emergency Medical Dispatchers

The main goal of this project is to help 9-1-1 emergency medical dispatchers save the lives of more cardiac arrest victims. The investigators will develop teaching tools to help the dispatchers recognize abnormal breathing that may indicate a victim as having a cardiac arrest. After training sessions, the investigators will see if dispatchers can get better at recognizing abnormal breathing, how often they give CPR instructions, and if use of the teaching tool will increase bystander CPR and the number of victims leaving the hospital alive.

Cardiac arrest is a leading cause of death in Canada; it is defined as the sudden cessation of cardiac mechanical activity. It is uniformly fatal if not treated within minutes. More than 85% of out-of-hospital cardiac arrest (OOHCA) occur in residential locations so public access to automatic external defibrillators, to restart the heart, are not helpful. The overall rate of survival for OOHCA rarely exceeds 8%.

Bystander cardiopulmonary resuscitation (CPR) is chest compression and ventilations provided by someone not on the emergency response team. A victim or cardiac arrest is almost 4 times more likely to survive when receiving bystander CPR. However, despite various attempts to improve bystander rates they have remained low, not exceeding 15% in Ontario. It has been shown that since the ambulance dispatch centres in Ontario implemented dispatch-assisted CPR instructions (given to callers while emergency vehicles were on the way), there was a significant increase in use.

Emergency medical dispatchers can identify about 70% of OOHCA cases over the phone. Agonal breathing (laboured breathing preceding death) may be misinterpreted as a sign of life, and is responsible for as much as 50% of missed diagnoses. There is no specific training on the significance of this sign, and minimal information about recognizing cardiac arrest. An educational intervention designed to better understand the significance of agonal breathing and to clarify the existing CPR instruction protocol will most likely increase the frequency of CPR instructions, bystander CPR rates, and potentially survival of victims of cardiac arrest.

Eligibility Criteria:
Inclusion Criteria:

* presumed cardiac origin
* event occurs in the catchment area of Training or Control Site
* resuscitation is attempted by a bystander and/or the emergency responders

Exclusion Criteria:

* patients younger than 16 years old
* patients who are "obviously dead" as defined by the Ambulance Act of Ontario (decomposition, rigor mortis, decapitation, or other)
* trauma victims including hanging and burns
* cardiac arrest of non-cardiac origin including drug overdose, carbon monoxide poisoning, drowning, exsanguination, electrocution, asphyxia, hypoxia related to respiratory disease, cerebrovascular accident, and documented terminal illness
Ventilation-perfusion (V/Q) Ratio and Alveolar Surface Area in Preterm Infants

To non-invasively estimate the alveolar surface area of the lungs of prematurely born infants by taking measurements of oxygen and carbon dioxide and utilizing functional morphometry.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Congenital or chromosomal anomalies
Anthropometric, Metabolic, Cardiovascular and Symptomatic Profile in Postmenopausal Women

The purpose of this study is to investigate anthropometric, metabolic, cardiovascular and symptomatic profiles in postmenopausal women.

When aging, the body composition changes, leading to a reduction of muscle mass and strength, and to an increase in total body fat. These body composition changes have especially been observed in postmenopausal women, due to the hormonal changes taking place. After the menopause, the gynoid fat distribution with fat deposits in the gluteo-femoral region changes to an android fat distribution with an increased upper body fat, especially in the abdominal region. These consequences of the menopause associated with a decrease in aerobic capacity and reduced total energy expenditure may lead to the metabolic syndrome (MetS). The aim of this study was to investigate the anthropometric, metabolic, cardiovascular and symptomatic profile in gynoid and android postmenopausal women.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* Caucasian
* 50-60 years of age

Exclusion Criteria:

* Neurological disease
* Pulmonary disease
* Cardiac disease
* Oncological disease
* Musculotendinous or articular injuries
* Hormone replacement therapy
* Cigarette smoking
3-Month Home-based Training With Whole Body Vibration Device in Patients With PAH (GALILEO-PAH-HOME)

In order to evaluate Long term effects of whole Body Vibration (wbv) in patients with PAH and CTEPH patients will get a training device to use at home for 3 months. Patients in the Intervention group will be introduced in the training program on the wbv-device in the study center 3-4 times and baseline Parameters will be collected before start of the home based training. Patients randomized into the placebo arm be introduced into the training program according to the interventional arm but not perfoming the exercises on the wbv-device but on the floor.

Screening (day -21 until day -7): Subjects will be evaluated according to In- and Exclusion critera

Randomization (day -7): Subjects will be randomized to either Intervention Group (training on wbv platform) or non-Intervention Group (training without wbv).

Introduction Week -1(-7d-d1): All subjects will receive introduction in their training

Month 1:

Day 1: From this day subjects are supposed to start their training accoridng to protocol

Day 2: Telephone Visit

Day 5: Telephone Visit

Day 7: Telephone Visit

Day 10: Telephone Visit

Day 13: Telephone Visit

Day 20: Telephone Visit

Day 27: Telephone Visit

Week 4, Day 28: Study center Visit: 6MWD, QoL-Questionnaire, AEs, re-training

Month 2:

Week 5, Day 34:

Week 6, Day 41:

Week 7, Day 48:

Week 8, Day 55:

Month 3:

Week 9, Day 62:

Week 10, Day 69:

Week 11, Day 76:

Week 12, Day 83: Final Visit

Eligibility Criteria:
Inclusion Criteria:

* Men and women age 18-90 years
* Signed informed consent
* Symptomatic PAH (idiopathic, hereditary or associated with systemic scleroderma)
* Persistend or inoperable CTEPH
* Invasively confirmed PAH
* 6MWT ≥ 50 - 450 m
* Stable specific therapy for at least 6 weeks
* Ability to perform bike test
* Ability to perform wbv training
* NYHA/WHO-FC II-III

Exclusion Criteria:

any other PAH/PH than idiopathic, hereditary, associated with systemic scleroderma or CTEPH

* Rehabilitation or other training concept performed within 6 weeks before inclusion
* pregnancy
* acute thrombosis
* newly implanted Hip or Knee
* recent bone fracture
* Disability to confirm consent
* NYHA/WHO-FC IV
* 6MWD below 50 or above 450 m