cyrilzakka/clinical-trials huggingface dataset:
A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD002 in Healthy Subjects

This is a first in human study of ETD002 a new drug being developed for the treatment of cystic fibrosis.The study is a randomised, double-blind, placebo-controlled, interventional study to assess the safety and tolerability of ascending single and repeat doses of inhaled ETD002 in healthy male and female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Males \& females using suitable methods of contraception or females of non-childbearing potential
* Consent to study participation
* Body weight ≥ 50 kg and body mass index within the range 19 - 30 kg/m2
* Vital signs assessments within normal ranges
* Healthy as determined following physical examination at screening visit
* Spirometry readings (FEV1 and FVC) to be ≥ 80% of predicted value

Exclusion Criteria:

* Acute or chronic illness detected at screening visit
* Respiratory tract infection within 4 weeks of the screening visit
* Use of prescription or OTC medication within 14 days of the screening visit
* History of regular alcohol consumption over recommended limits within 6 months of the study, or history/evidence of alcohol or drug abuse
* Smoking or use of tobacco products within 6 months of screening
* Abnormal blood/urine laboratory screening test results
* Current, or history of, allergy that may be contraindicated
Efficacy Analysis of Cetuximab Plus Irinotecan in Patients With Wild-type KRAS Without Regard to Epidermal Growth Factor Receptor (EGFR) Expressions

The purpose of this study is to investigate the response rate of cetuximab plus irinotecan every 2 weeks in patients harboring wild-type KRAS with and without detectable EGFR-expressing metastatic CRC after failure to irinotecan in an exploratory manner.

Twenty patients with positive-EGFR results and 20 patients with negative-EGFR results will be accrued in this study. All patients should have wild-type KRAS.

Eligibility Criteria:
Inclusion Criteria:

* Colorectal adenocarcinoma, Wild KRAS, 18-75 yr
* Estimated life expectancy of more than 3 months
* ECOG performance status of 0 to 1 at study entry
* Adequate bone marrow function
* Adequate liver function
* Documented progression during or within 3 months of irinotecan-containing regimens as a first-line chemotherapy
* Immunohistochemical evidence of a presence or absence of EGFR expression by PharmDx Kit
* Informed Consent

Exclusion Criteria:

* Central nervous system (CNS) metastases or prior radiation for CNS metastases.
* Intestinal obstruction or impending intestinal obstruction due to peritoneal carcinomatosis
* Surgery (excluding biopsy for diagnosis) during 4 weeks prior to inclusion in the study.
* Evidence of gastrointestinal bleeding
* Exposure to Cetuximab
* Prior administration of monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted treatment
* KRAS mutant Status
* Patients with serious toxicity to previous irinotecan-based chemotherapy
* Other serious illness or medical conditions
The Role of Genetic Mutations and of Circulating mRNAs in Uveal Melanoma

The aim of the study is to identify genetic and epigenetic biomarkers in uveal melanoma, and to evaluate their diagnostic and prognostic role.

In particular, the specific objectives are:

1. to identify the circulating somatic mutations associated with uveal melanoma;
2. to identify the de-regulated miRNAs associated with uveal melanoma;
3. to evaluate the diagnostic and prognostic role of the identified genetic and epigenetic markers;
4. to identify possible therapeutic targets.

This is a prospective, multicentric, case-control study, aimed at studying the gene and epigenetic mechanisms involved in uveal melanoma.

Patients with uveal melanoma, will be enrolled. For each subject included in the study, in a blood sample will be searched the mutations of the GNA11 and GNAQ genes and the expression of the following microRNAs: miR - 506-514 cluster, hsamiR - 592 and hsa - miR - 199a - 5p; the digital PCR droplet system will be used.

The study will not change the diagnostic-therapeutic process adopted in the clinical practice and will have no influence on the clinical management of enrolled patients.

A group of age sex matched controls will be recruited among patients scheduled for cataract surgery.

The sample size was calculated to detect, with a power of 80% and a confidence interval of 95%, a difference of 13.5% between the incidence of mutation of the GNA11 gene in patients with melanoma and healthy controls. (13.5% vs 0%). Overall, at least 51 patients with uveal melanoma and 51 controls will be recruited, for a total of at least 102 subjects.

Eligibility Criteria:
Inclusion Criteria:

* subjects diagnosed with uveal melanoma
* both sexes
* age ≥ 18 years

Exclusion Criteria:

* a) autoimmune diseases
* b) tumors
* c) kidney diseases
* d) atherosclerosis
* e) subjects undergoing anti-inflammatory therapies.
Training to Modify Fixational Eye Movements for Optimizing Visual Performance in People With Central Vision Loss

People with central vision loss almost all have exaggerated fixational eye movements when compared with people with normal vision (e.g. larger amplitudes of microsaccades and ocular drifts). Central vision loss primarily results from eye diseases or disorders that affect the macular region of the retina, such as age-related macular degeneration (AMD) and Stargardt disease. The clinical wisdom is that exaggerated fixational eye movements are detrimental to vision. This forms the basis of the increasing number of clinical trials that use fixation stability (variability of eye positions during fixation) as an outcome measure to evaluate the effectiveness of interventions on age-related macular degeneration or other retinal diseases, despite the lack of causal evidence supporting or refuting a relationship between fixational eye movements and functional vision. If excessive fixational eye movements are indeed detrimental to vision for people with central vision loss, can we reduce the amount of their fixational eye movements, thus improve their fixation stability? And if so, does that lead to improved functional vision? The goal of this study is to examine the hypothesis that retinal image motion due to abnormal fixational eye movements can be modified through fixation training, with accompanied improvements in functional vision as a result.


Eligibility Criteria:
Inclusion Criteria:

Participants with normal vision:

* age 18 or above
* best corrected visual acuity of at least 20/20 in each eye
* cataracts, if present, must be minimal (grade 1 or below according to the Lens Opacity Classification System)
* normal contrast sensitivity for their ages
* stereoacuity at least 40 seconds of arc
* no history or signs of any retinal diseases

Participants with macular disorders:

* age 18 or above
* macular disorder present in both eyes
* presence of at least one scotoma within the central 5 degrees of the visual field and with best corrected visual acuity of at least 20/400 in the better-seeing eye
* no foveal island of vision left (i.e. absolute scotoma must include the foveal area)
* cataracts, if present, must be grade 2 or lower according to the Lens Opacity Classification System II

Exclusion Criteria:

Participants with normal vision:

* younger than 18 years of age
* best corrected visual acuity worse than 20/20 in each eye
* cataracts worse than grade 1 according to the Lens Opacity Classification System II
* abnormal contrast sensitivity for their ages
* stereoacuity worse than 40 seconds of arc
* history or signs of any retinal diseases

Participants with macular disorders:

* younger than 18 years of age
* macular disorder absent in at least one eye
* no scotoma within the central 5 degrees of the visual field in the better-seeing eye
* best corrected visual acuity of worse than 20/400 in the better-seeing eye
* foveal island of vision
* cataracts worse than grade 2 according to the Lens Opacity Classification System II
The Effect of Hot Perfoming on the Soles of the Feet in the First Stage of Labor on Labor

This research was conducted to determine the effect of applying heat to the soles of the feet during the active phase (5-10 cm dilation) of the first stage of labor. It is a randomized controlled experimental study. In the intervention group, hot gel packs with a temperature of 40-42°C were applied to the soles of the feet for 20 minutes when the cervical dilation was 5 cm. These applications were repeated in the same manner at one-hour intervals until the cervical dilation reached 10 cm. The procedure was terminated when the cervical dilation reached 10 cm. Routine services were applied to the control group. Data were collected using a personal information form, Partograph form, APGAR score, Visual Analog Scale (VAS), and Birth Satisfaction Scale Short Form (BSS-SF)

This research was conducted to determine the effect of applying heat to the soles of the feet during the active and transition phase (4-10 cm dilation) of the first stage of labor. The research is a randomized controlled experimental study and is conducted in Sivas Cumhuriyet University Practice and Research Hospital Maternity Unit. When the sample size was taken as α = 0.05 and β = 0.10 and 1-β = 0.90 to represent the population in the research, there were 30 individuals in each group and the power of the test was found to be P = 0.90640. The application procedure started with the application of hot gel packets at a temperature of 40-42°C to the soles of the feet of the women in the intervention group for 20 minutes when cervical dilation reaches 5 cm. The first Visual Analog Scale (VAS) evaluation was conducted after the application. Conduction is followed by more evaluations at the 25th (5 minutes after the application), 35th (15 minutes after the application), and 50th minute (30 minutes after the application). These applications were repeated every hour until cervical dilation reached 10 cm. The applicatilon procedure has been stopped after cervical dilation reached 10 cm. The control group received routine service and VAS at the same times. Data were collected with personal information form, Partograph form, APGAR score, Visual Analog Scale (VAS) and Birth Satisfaction Scale Short Form (BSS-R) Wilcoxon test, Mann Whitney U test, Chi-square test, Exact test, Friedman test, t test were used to evaluate the data. The data error level was accepted as 0.05.

Eligibility Criteria:
Inclusion Criteria:

* 1. The pregnant woman must be 19 years or older 2. 38-42. being in the gestational age, 3. Having a singleton pregnancy, 4. The fetus is in a vertex position, 5. Cervical dilatation is 5 cm. to be, 6. Not having a diagnosed chronic physical disease, 7. Not having a diagnosed psychiatric disease, 8. Absence of risky pregnancy and birth, 9. There is no abnormality in the fetus, 10. Being able to speak Turkish and be literate 11. Having a primigravida

Exclusion Criteria:

* Not meeting inclusion criteria
Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours

This first-in-human study aims to establish the maximum tolerated dose of PG545 and to evaluate its safety in subjects with advanced solid tumours. In addition the study will explore whether PG545 exposure results in changes to chemicals produced by the body that are associated with cancer growth and spread.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years.
* Histological or cytological documentation of non hematologic, malignant solid tumour.
* Have failed at least one previous therapeutic regimen.
* Measurable disease according to RECIST 1.1.
* Life expectancy \>= 12 weeks
* ECOG Performance Status of 0 or 1
* Written, signed and dated informed consent
* Able and willing to meet all protocol-required treatments, investigations and visits.
* Have adequate organ function

Exclusion Criteria:

* Clinically significant non-malignant disease.
* Active CNS metastases.
* Subjects with uncontrolled diabetes.
* History of clinically significant adverse drug reaction to heparin or other anti-coagulant agents
* History of immune-mediated thrombocytopaenia or other platelet abnormalities or other hereditary or acquired coagulopathies.
* Concomitant use of aspirin (\> 150 mg/day), NSAIDs (except COX-2 selective inhibitors), vitamin K antagonists (other than low-dose prophylactic use), heparin within two weeks prior to randomisation, or other anti-platelet drugs.
* History of severe allergic, anaphylactic or other significant adverse reaction to radiographic contrast media
* Known seropositivity to the human immunodeficiency virus (HIV)
* Women who are pregnant or breast-feeding.
* Women of child-bearing potential and male subjects who are partners of women of childbearing potential who are unable or unwilling to practice a highly effective means of contraception.
* Active substance abuse
* Subjects who have received an investigational agent within 28 days prior to Cycle 1 Day 1.
Dexamethasone Vs. Dexmedetomidine for Popliteal Nerve Block in Pain Management After Pediatric Ankle and Foot Surgery

Effect of perineurial dexamethasone and dexmedetomidine on popliteal nerve block duration for pediatric, ankle or foot surgery

This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.

After scoliosis surgery, children need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.

The safety of local anesthesia is essential in children due to the much lower toxicity threshold of local anesthetics. An effective adjuvant, such as Dexamethasone or Dexmedetomidine, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.

There is considerable research where intravenous and perineural dexamethasone and Dexmedetomidine use has been compared in adults. However, there is a massive lack of research regarding children.

In this study, investigators compare perineural Dexamethasone and Dexmedetomidine. Group 2 has dexamethasone doses of 0.1mg/kg, and group 3 has 0,1ug/kg Dexmedetomidine added to the local anesthetic.

The investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* all children scheduled for ankle or foot surgery
* aged \> 3 months \< 7 years

Exclusion Criteria:

* age \< 3 months
* age \> 7 years
* infection at the site of the regional blockade
* coagulation disorders
* immunodeficiency
* ASA= or \>4
* steroid medication in regular use
* chronic pain
Prehabilitation of Elderly Patients With Frailty Syndrome Before Elective Surgery (PRAEP-GO)

The aim of the study is to evaluate the effect of a shared decision-making conference and three-week prehabilitation program on the outcome "care dependency" one year after surgery. The cost-effectiveness of the intervention will also be evaluated in this N = 1400 patient, national multicenter, assessor-blinded, randomized, pragmatic, controlled, parallel-group, clinical trial.

The objective of PRÄP-GO is to establish and employ a suitable preoperative case-care management system to improve the short and long-term outcome of elderly surgical patients with signs of a frailty syndrome, improving postoperative quality of life and reducing care dependency by a three-week individualized prehabilitation program.


Eligibility Criteria:
Study patients:

Inclusion Criteria:

* Age ≥ 70 years
* Consent by Patient or Legal Representative
* Elective surgery planned
* Expected anesthesia duration≥ 60 min
* Statutory health insurance
* Frailty syndrome (≥1 positive out of 5 standardized parameters according to the Physical Frailty Phenotype according to Fried et. al.)

Exclusion Criteria:

* Severe cardiac or pulmonary disease (NYHA IV, Gold IV)
* Intracranial interventions
* Moribund patients (palliative situation)
* Not enough language skills
* Participation in another interventional rehabilitation study or other interventional clinical trial that has not been approved by the study management committee (Exception: Participation in adjuvant intervention study)
Validation of a Comprehensive Health Status Assessment Scale in Elderly Patients (≥ 65 Years) With Hematological Malignancies

The elderly comprise the most prevalent population in oncology practice. The available evidence suggests that old patients are undertreated patients, mainly because of their advanced age, regardless of whether they are highly functional patients, they do not present co morbidities and could benefit from oncology therapies.

Treatment planning must consider several health indices that are useful when it comes to detecting geriatric problems that could affect the patient's treatment experience. The complete comprehensive geriatric evaluation stands out as cornerstone among other validated tools that do not work as isolated instruments; however, its length and complexity may hinder its routine use in clinical practice for decision making.

The purpose of this study is to validate a comprehensive health status assessment scale in elderly patients (≥65 years) with hematological malignancies that, while integrating the essential dimensions of geriatric assessment and, with the same precision as the currently available valid tools, is shorter and easier to apply, so it can be incorporated into the daily practice and that aids in clinical decision making objectively.

If so, this information would help identify patients that could benefit from a specific oncology treatment, thus contributing to developing a targeted intervention plan and to optimizing the cancer results in this patient population.


Eligibility Criteria:
Inclusion Criteria:

Patients ≥ 65 years old. Treatment-naïve patients

Newly diagnosed patients who belong to one of the 3 following groups:

Patients with MDS (any risk grade as per IPSS) or AML Patients with multiple myeloma (symptomatic or not) or Patients with chronic lymphocytic leukemia (including A status) Patients who have granted their informed consent.

Exclusion Criteria:

Not fulfilling selection criteria
OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia

Obstructive sleep apnea (OSA) is a sleep-related respiratory dysfunction. The prevalence of OSA is increasing with the increasing rates of obesity and elderly population worldwide. Perioperative anesthesia management should be adjusted to improve patient safety in patients with OSA. In OSA patients, positive pressure ventilation support may be required in the preoperative period, various ventilation strategies may be required in the intraoperative period, different pharmacologic agents may need to be avoided, and intensive care unit follow-up or noninvasive ventilation support may be required in the postoperative period. However, it is reported that a significant percentage of OSA patients remain undiagnosed. ASA (American Society of Anesthesiologists) has reported the criteria that should be questioned in order to determine the risk of patients in terms of OSA and to initiate the diagnostic process in risky patients and to make appropriate anesthesiologic arrangements in the perioperative period. In addition, the STOP-BANG assessment scale, which is widely used all over the world in OSA risk assessment, is also used in OSA risk assessment. It is thought that dental caries and extraction needs may be higher in OSA patients, especially since open-mouth sleeping accompanies the situation. In this respect, it is also important for patients to be diagnosed with OSA as it may prevent dental damage due to open-mouth sleeping in the future. Identifying patients at risk for OSA and directing them to the diagnostic process is very important for patient safety. Within the scope of the study, the criteria recommended by ASA and STOP-BANG score will be evaluated and recorded. Risk stratification in terms of STOP-BANG questionnaire and ASA criteria will be done separately for each patient and for each classification method. Patients at high risk will be consulted to the relevant medical department in the preoperative period for further investigation and treatment. In addition, it is aimed to correlate the risk levels determined in the study with postoperative respiratory complications and recovery time.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18-80 years of age who apply to the anesthesia clinic for dental procedures planned to be performed under general anesthesia
* Patients without a previous diagnosis of OSA

Exclusion Criteria:

* Individuals who do not want to participate in the study
* Patients previously diagnosed with OSA
* Necessity of emergency surgery
Phase I/II Trial of Doxil and Hyperthermia for Breast Cancer Patients With Chest Wall Recurrence or Stage IV Disease With Locally Advanced Breast Cancer

Purpose: The purpose of this protocol is to evaluate the combination of Doxil chemotherapy and heat treatment for recurrent breast cancer located on the chestwall following mastectomy. This protocol also includes patients with metastatic breast cancer who have not had mastectomy but have advanced tumor remaining within the breast. Doxil is the drug adriamycin (also called doxorubicin) encapsulated in liposomes, which coats the drug with a small amount of lipid (fat). This chemotherapy is in a newer form which can be better delivered to the tumor tissue without causing as much systemic toxicity. We are combining heat treatment with this drug in an effort to further increase the delivery of drug to the tumor, which may give an increased tumor response.

Methods: The patients will be treated with chemotherapy followed by heat treatment. This will be given for 6 cycles approximately every 4 weeks. For the first cycle patients will need to be hospitalized 3 days for measurement of blood levels of drug as well as some additional radiology studies which will help us to determine whether the drug is preferentially distributed within tumor.


Eligibility Criteria:
Inclusion Criteria:

* Patients with recurrent or metastatic breast cancer
Comparison of ISQ in Implants Placed in Antral Area on Native Bone vs Regenerated Bone

Compare ISQ values of implants placed in antral area in native bone vs regenerated bone with a follow-up at 3 months to compare values changes.

The stability of dental implants is influenced by the type of bone in which the implant is placed. Native bone tends to provide better initial stability due to its density and quality, while regenerated bone, it is logical to think that it may present less stability due to the quality of the generated bone and the presence of defects in the treated area.

In this study it has been observed that after 3 months more stability is observed in the antral area, measured in ISQ resonance frequency in implants on regenerated bone, which surprises us and this result is explained in detail in said study.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Total superior edentulism or antral zone edentulism
* Accepted study and signed inform consent

Exclusion Criteria:

* Patients under 23 years old
* Non accepted study or signed inform consent