cyrilzakka/clinical-trials huggingface dataset:
Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

The objective of this clinical study is to compare the safety and efficacy of mapracorat ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation and pain following cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are candidates for routine, uncomplicated cataract surgery.
* Subjects who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye.
* Subjects who have ≥ Grade 2 (6 - 15 cells) AC cells in the study eye following cataract surgery (postoperative day 1).

Exclusion Criteria:

* Subjects who have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
* Any intraocular inflammation in either eye (cells or flare score greater than Grade 0 at slit lamp examination) or ocular pain greater than Grade 1 in the study eye at the Screening Visit.
* Presence of active external ocular disease: infection or inflammation of the study eye.
* Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
* Subjects who currently require or are expected to require treatment with any medication listed as a disallowed medication per the Disallowed Therapy section of the protocol.
Pancreatic Enzyme Suppletion in Pancreatic Cancer

This study will evaluate the effect of immediate pancreatic enzyme suppletion on the physical and mental health status and survival of patients who are diagnosed with pancreatic cancer and are highly likely to develop exocrine pancreatic insufficiency during their disease process.

Weight loss in cancer is caused by primary tumour effects and secondary effects (e.g. side effects of treatment, mechanical and intestinal obstruction). In pancreatic cancer, additional weight loss and malnutrition may be due to the development of exocrine pancreatic insufficiency (EPI). The presence of EPI in pancreatic cancer is frequently overlooked, because the focus of treatment is directed at possible surgery or chemotherapy and its potential side effects. Although studies have proven that pancreatic enzymes may prevent or decrease weight loss, they are seldom being prescribed.

Eligibility Criteria:
Inclusion Criteria:

* Adenocarcinoma of the pancreas (histologically confirmed)
* Normal exocrine pancreatic function (Fecal Elastase test \> 0.2 mg/g)
* Capable and willing to follow instructions given by the physician.

Exclusion Criteria:

* Other causes of fat malabsorption (celiac disease, IBD, and major gastrointestinal surgery).
* \< 18 years.
Whole Exome Screening of Newborns

The aim of the study is to obtain the initial experience of the inclusive genetic screening of newborn.

Two groups of newborns born in RCOGP will be enlisted to the study:

1. newborns without developmental features having no variations according to an inherited diseases screening;
2. newborns showing either phenotypic features or deviations according to MS screening.

The residual volume of the cord blood of all newborns form both groups will be collected and subjected to the whole exome sequencing. The sequencing data will be analyzed in "screening" mode for the first group while for the second group analysis will be performed taking the respective phenotype into account.

The study is planned to cover 7000 newborns in total.


Eligibility Criteria:
Group 1 (newborns without features):

Inclusion Criteria:

* Infants born in the RCOGP, showing no development features and with no inherited diseases revealed by common screening
* Informed consent signed by a newborn's representative

Exclusion Criteria:

* Parents refuse to participate
* Parent(s) younger 18 years
* Parent(s) unable to make decisions
* The infant is older 30 d
* Blood cannot be collected from the infant

Group 2 (newborns with phenotypic features)

Inclusion Criteria:

* Infants showing either phenotypic features or deviations according to MS screening
* Informed consent signed by a newborn's representative

Exclusion Criteria:

* Parents refuse to participate
* Parent(s) younger 18 years
* Parent(s) unable to make decisions
* Blood cannot be collected from the infant
* Detailed description of the phenotype is not available
* The infant's exome has been already sequenced
Two Treatment Regimens of Cocamide DEA Lotion for Head Lice

To assess the efficacy and safety of 10% Cocamide DEA using two treatment regimens in the eradication of head lice. To assess the ability of each treatment regimen to kill all viable ova and to assess patient acceptability of the product in use

A previous study found that a formulation of 10% cocamide diethanolamine (DEA) aqueous lotion showed some efficacy to eliminate head louse infestation but that the treatment regimen was inadequate to kill all lice or louse eggs. This study has been designed to compare two different application regimens that have been shown effective in vitro.

A planned total of 120 patients who, following examination, are found to suffer from active head lice infestation will be recruited to the trial. The patient will be treated with 10% cocamide DEA lotion using the appropriate treatment regimen according to the randomization code from a pre-prepared listing in balanced blocks of 12.

Group 1: 10% cocamide DEA is applied directly to dry hair, the excess water evaporated off using a hair dryer and is then left for 8 hour/overnight before washing off with clean water.

Group 2: 10% cocamide DEA is applied directly to dry hair, the excess water evaporated off using a hair dryer and is then left for 2 hours before washing off with clean water. A follow up treatment is given after 7 days.

Treatments will be applied by experienced investigators throughout the study. Assessments will be made by other investigators unaware of the treatment regimen used.

After treatment (day 0), follow up assessments will be performed on days 4, 8,11 then again at day 14 after which they will leave the study. Any adverse events or side effects from the treatments will be monitored during the study.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients over the age of 4 who are found to have a head louse infection.
* Patients who give written informed consent and, if the patient is under 16 years of age, whose guardian gives written informed consent to participate in the study.
* Available for the duration of study i.e. 15 days.

Exclusion Criteria:

* Patients with a known sensitivity to paraben preservatives.
* Patients who have been treated with other head lice products within the last 2 weeks.
* Patients who have undergone a course of antibiotic treatment within the last 4 weeks.
* Patients who have any persistent skin disorder of the scalp (i.e. eczema, chronic dermatitis, psoriasis).
* Patients whose hair has been bleached, colour treated or permed within the last 4 weeks.
* Patients who have participated in another clinical trial within 1 month prior to entry to this study.
* Patients who have already participated in this clinical trial.
A Cohort Establishment Study of Total Management of Ovarian Cancer

A cohort establishment study of total management of ovarian cancer (including fallopian tube cancer and primary peritoneal cancer).

1. To investigate the effects of surgery, chemotherapy, maintenance therapy and related factors on the prognosis and quality of life of patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer);
2. To study the postoperative recovery of patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer), perioperative complications, adverse reactions after chemotherapy, adverse reactions during targeted drug maintenance therapy, and explore possible effective preventive measures;
3. The prognostic factors of ovarian cancer (including fallopian tube cancer and primary peritoneal cancer) were analyzed;
4. To study the efficacy and safety of PARPi in clinical application in patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer).

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with ovarian cancer (including fallopian tube cancer, primary peritoneal cancer) and intended to be treated in our hospital;
2. Can cooperate with later follow-up.

Exclusion Criteria:

1. Patients with other malignant tumors or previous history of other malignant tumors;
2. Have cognitive impairment.
Limb Remote Ischemic Conditioning and Cerebrovascular Reserve

Cerebrovascular reserve (CVR), defined as the increase in cerebral blood flow (CBF)in response to a vasodilatory stimulus, is known to reflect the compensative capacity of the brain to maintain adequate blood flow in the face of decreased perfusion due to arterial stenosis. CVR dysfunction has been identified as an independent risk factor for ischemic stroke. Limb remote ischemic preconditioning （LRIC) has been suggested as a protective therapeutic modality against brain ischemia. So it is worth to detect whether LRIC can improve the CVR ability in ischemic cerebrovascular disease patients.


Eligibility Criteria:
Inclusion Criteria:

- (1)Symptomatic intracranial arterial stenosis measuring \>=50% by angiography or \>=70% by ultrasound, CT angiography (CTA), or magnetic resonance angiography (MRA);(2)Age range 18-80 years;(3)Compared with normal brain tissue, the reduction of cerebral glucose metabolism (CGM) and/ or cerebral blood flow (CBF) in the focal area\>=8%;(4)Stable vital signs, normal renal and hepatic functions; (5)No hemorrhagic tendency;(6)Subject or his or her legally authorized representative was able to provide an informed conised.

Exclusion Criteria:

-(1)Uncontrolled hypertension (defined as systolic blood pressure\>=200 mmHg despite medications at enrollment); (2)Any vascular, soft tissue, or orthopedic injury (eg, superficial wounds and fractures of the arm) that contraindicated bilateral arm ischemic preconditioning;(3)Peripheral vascular disease (especially subclavian arterial and upper limb artery stenosis or occlusion); (4)Hematologic disease;(5)Severe or unstable concomitant disease;(6)Can not tolerate LRIC treatment;(7)No informed consent.
The Effect of Virtual Reality Application on Pain and Anxiety Level in Stone Crushing With Shock Waves: A Randomized Controlled Trial

This research was planned as a randomized controlled experimental study in order to evaluate the effect of virtual reality application on pain and anxiety caused by the procedure during stone crushing process (ESWL) with shock waves.

Although urinary tract stones often remain asymptomatic at first, they can cause pain, hematuria, infection, decreased kidney function and kidney failure over time and can seriously affect the quality of life of people if not treated with appropriate methods.

Extracorporeal shockwave lithotripsy (ESWL) has been practiced as a treatment method to remove urolithiasis from the kidneys and ureters since the early 1980s.

The process is based on the principle that the sound waves obtained from a source other than the body are turned into shock waves and sent to the stone and the stone is broken down.

Relief of pain and anxiety during ESWL; In addition to maintaining patient comfort and satisfaction, it is extremely important to reduce the movement of the patient during the procedure and to facilitate the imaging and targeting of the stone.

Diverting attention is one of the most preferred methods to reduce the pain that occurs in patients while the diagnosis and treatment procedures are carried out. This method; It is a method that focuses the attention of patients on a different point and keeps the symptoms they experience under control and reduces them.

Strategies to divert attention include the application of virtual reality, which has been one of the methods that have attracted attention in recent years.

The individual focuses his attention on the image by moving away from real life with the glasses connected to the device worn on his head and the sounds coming from the headphones and feels as if he is in a different world thanks to these glasses.

In practice, it is aimed to reduce the patient's pain, discomfort and anxiety by drawing the patient's attention from pain and painful treatment procedures to a fun virtual environment.

Eligibility Criteria:
Inclusion Criteria:

* Applying to the stone crushing unit for the first time
* Body mass index below 30
* Those aged 18-65 who are literate and have no vision or hearing problems
* Have not taken any analgesics other than the analgesic routinely administered before the procedure

Exclusion Criteria:

* Untreated urinary tract infections
* Severe skeletal system malformations that prevent focusing on the stone
* Severe obesity
* Arterial aneurysm near the stone
* Patients with anatomical obstruction conditions in the distal part of the stone
Effects of Nursing Patient Handover

This study was planned in a quasi-experimental design, focusing on the feasibility, evaluation, and implementation of patient handover between nurses, and the effect of interventions to increase their effectiveness on the patient's satisfaction with care, trust in the nurse, and the quality of nurses' patient handover.The main question it aims to answer is:

Does the intervention implemented in nurses' patient handover increase patients' satisfaction with care, its effect on their trust in nurses, and the quality of nurses' patient handover?

This research was conducted between January and September 2022 at Adana City Education and Training Center.

It was carried out in the Research Hospital General Surgery Intensive Care Clinic (Intensive Care Clinic), Internal Medicine Clinic (Internal Clinic), General Surgery Clinic (Surgical Clinic). The study was carried out in a quasi-experimental design, with the control and experimental groups being the same, before the intervention, in the short term after the intervention (2 weeks after the intervention) and in the long term after the intervention (8 weeks after the intervention).

Training prepared as an expert opinion on patient handover, starting to use the standard patient handover form for each patient, ensuring standardization in handover and supporting this improvement work by managers were expressed as interventions. Training offered; It includes the importance of patient handover, how to ensure standardization and why we should use the standard patient handover form. After the training content was prepared, expert opinions were obtained from 5 people, including clinicians and academicians. The trainings were held in the meeting room of each clinic in 3 different sessions, reaching all nurses in an average of 45 minutes. The trainings were conducted interactively using written, visual and video methods. After the training, the standard patient handover form, which nurses should use in writing and verbally for each patient, was applied by the researcher at the bedside and how to use it was explained. The presentation prepared for the training was shared with nurses.

Eligibility Criteria:
Inclusion Criteria:

* Nurses using the standard patient handover form
* Nurses involved in patient handover.
* The patient over 18 years of age
* The patient understand and speak Turkish
* The patient have no hearing impairment
* The patient have no psychiatric disorder that would reduce his or her ability to comprehend and understand,
* The patient have no communication problems, have no contact isolation,
* Patients and nurses agree to participate in the research.

Exclusion Criteria:

* Nurses and patients no volunteer to participate in the research
* Nurses who do not use standard patient handover forms
* The patient under 18 years of age
TransIent Perivascular Inflammation of the Carotid Artery (TIPIC) Syndrome: Clinical and Radiological Follow-up

TIPIC syndrome (previously called carotidynia) is a rare entity of unknown cause, where the patient has a temporary cervical pain associated with a suggestive inflammation around the carotid artery. Usually considered as a unique and benign episode, some patients have recurrences and the follow-up is usually short. In this study the investigators aim to evaluate patients who presented a TIPIC episode at least 3 months before, clinically and with a cervical doppler ultrasound


Eligibility Criteria:
Inclusion Criteria:

- Patients with at least one episode of TIPIC syndrome for more than 12 months
SpineJack® Versus Conservative Treatment Study (SPICO Study)

This study will compare two standard treatments in acute stable traumatic vertebral fractures (types A1 and A3.1 by Magerl Classification). The two treatments are as follows:

1. SpineJack® system
2. Conservative Orthopedic Management consisting of brace and pain medication.

100 subjects (18 to 60 years old) will be enrolled (1:1) with one to two painful traumatic fractures, non-pathological (types A1 and A3.1 by Magerl Classification).

Subjects will be followed at admission, procedure, discharge, 1 month, 3 months, 12 months and 24 months post Vertebral Compression Fracture (VCF) reduction procedure or the set-up of the brace.

The estimated enrollment period is 12 months and each patient should perform a 24 months follow-up period. Therefore, the total study duration is estimated to be 36 months for the complete study.

Eligibility Criteria:
Inclusion Criteria:

1. Patient must have signed the consent form
2. Male or Female between 18 and 60 years old
3. One to two painful traumatic fractures, non-pathological, traumatic vertebral fracture is less than 10 days, between T11 and L5, type A1 and A3.1 according to Magerl classification. All the fractures should meet the inclusion criteria (deformity, etiology, technical possibility of performing the procedure).
4. Vertebral kyphosis angle \>10°
5. Patient is eligible to treatment with brace
6. Technical feasibility of a SpineJack® procedure and brace 1 to 5 days after screening/baseline

Exclusion Criteria:

1. Vertebral fracture more than 10 days old
2. Spontaneous osteoporotic vertebral fracture
3. Neurological signs or symptoms related to the vertebral fracture
4. Vertebral kyphosis angle \>30°
5. Active systemic or local infection at baseline
6. Patient with substance abuse
7. History of intolerance or allergic reaction to titanium or acrylic compounds
8. Fracture geometry making the insertion of the implant impossible
9. Malignant lesions
10. Any other medical illness or condition that, in the investigator's opinion, is likely to impair long-term follow-up (e.g., cancer) or greatly increase the risk of surgery\*
11. Patient on long-term steroid therapy (steroid dose ≥ 30 mg /day for \> 3 months)
12. Patient presenting with a non-correctable spontaneous or therapeutic coagulation disorder.
13. Non-compliant patient: Impossibility to participate in the study and to be followed-up for 2 years.
14. Participating in any other investigational study
15. Female patients who are pregnant, breastfeeding, or planning to get pregnant during the course of the study
16. Patient not affiliated to social security \*: including but not limited to patients with contraindications for general anesthesia (surgeon expertise)
The Effect of Additional Propacetamol Infusion on Post Procedural Outcome and Opioid Consumption During Catheter Ablation of Atrial Fibrillation.

Sedation for catheter ablation of atrial fibrillation should be performed to achieve analgesia, immobilization, and maintenance of airway. Various anesthetic agents such as propofol, dexmedetomidine, and midazolam were investigated to achieve this goal. However, propofol and midazolam causes respiratory depression and dexmedetomidine occasionally accompanies hypotension or hypertension and bradycardia. Therefore, anesthetic agent that does not induce respiratory depression with stable hemodynamics is needed.

Propacetamol (Denogan®, Yungjin, Seoul, Korea) is injectable prodrug of acetaminophen and 1st line drug for fever and pain. In a previous study, paracetamol reduced morphine consumption after surgery. And paracetamol does not cause respiratory depression. Thus, the investigators hypothesized that addition of propacetamol to previously used sedatives midazolam-remifentanil will reduce opioid consumption during the catheter ablation.

Therefore, the investigators designed this study to investigate the role of addition of propacetamol to previous used midazolam-remifentanil sedation. This study will compare the opioid consumption and respiratory effect of propacetamol with placebo-control for catheter ablation of atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* patients who are scheduled to undergo catheter ablation for arrhythmia

Exclusion Criteria:

* Subjects are ineligible if they have liver disease, kidney disease,
* American society of anesthesiology class 3 or 4,
* age under 20 years,
* cognitive dysfunction,
* disabling mental change disorder,
* patients are unable to communicate or speak Korean
PET Guided Bone Marrow Biopsy vs Trephine Bone Marrow Biopsy

Newly diagnosed lymphoma patients were recruited for FDG PET/CT and PET/CT guided bone marrow biopsy. All the patients also underwent routine bone marrow sampling from the posterior superior iliac spine.

Newly diagnosed patients underwent FDG PET/CT for whole-body staging. All the PET/CT images were analyzed by a qualified nuclear medicine physician. The bone marrow FDG uptake was classified as negative, focal, multifocal and diffuse marrow uptake. A PET/CT guided metabolic bone marrow sampling from the FDG avid marrow-based lesion was done. However, patients with diffuse FDG avidity or no uptake in the marrow differed for PET-guided biopsy. All the patients underwent routine trephine bone marrow sampling. Bone marrow infiltration (final diagnosis) was established based on trephine bone marrow sampling and FDG PET/CT targeted bone marrow biopsy results in the present study. The results of both the biopsies were correlated with the final diagnosis.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed cases of lymphoma (both HL and NHL).
2. Hypermetabolic bone marrow lesions on staging 18F-FDG PET/CT, which are accessible for biopsy.
3. Aged between 18 -80 years.
4. Informed consent prior to the procedure.

Exclusion Criteria:

1. Previously treated/relapsed lymphoma.
2. Initiation of therapy (chemotherapy, radiation therapy) and/or hematopoietic growth factor injections before 18F-FDG PET/CT or BMTB.
3. Patients who underwent a prior BMTB to evaluate the role of BMI.
4. Patients with pre-existing bleeding diatheses like hemophilia, coagulopathy, INR \> 1.2 and platelet counts \< 50,000/mm3,
5. Patients who refuse to provide informed consent.
6. No 18F FDG avid skeletal lesions.
7. Pregnant/Lactating female patients.
8. Non-cooperative patients.