cyrilzakka/clinical-trials huggingface dataset:
Biopsy Size and Pain Perception During Colposcopic Biopsy

The investigators will investigate patients pain and biopsy size during colposcopic biopsy. The investigators will use tenaculum randomized patient with or without intracervical blockage.

The study was designed four arms. The investigators will perform colposcopy because of various causes. The first arm is used tenaculum and performed intracervical blockage. The second arm is not used tenaculum and performed intracervical blockage. The third arm is used tenaculum and not performed intracervical blockage. The fourth arm is not used tenaculum and not performed intracervical blockage and then we will study patients pain and biopsy size during colposcopic biopsy. Pain reduce and biopsy size are very important for patient and diagnose of the cervix cancer.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 year-old women who had colposcopic biopsy

Exclusion Criteria:

* Had orthopedical problems
* Analgesic allergy
* Have previous cone biopsy
* Analgesic use until six hours before colposcopy
* Advanced cervicovaginal atrophy
* Linear Visual Analog Score for pain is used
Vistakon Investigational Lens Worn as a Single Use Daily Wear

This study is intended to show that the investigational contact lens is clinically equivalent to a currently approved contact lens, when worn as single-use on a daily basis.


Eligibility Criteria:
Inclusion Criteria:

* eyes must be best-corrected to a visual acuity of 20/30 or better in each eye
* must be able and willing to wear soft contact lenses on a single use, daily wear basis for the duration of the study
* distance spherical contact lens prescription must be within the range available for the study

Exclusion Criteria:

* systemic diseases which may interfere with contact lens wear
* ocular infection or clinically significant ocular disease
* any previous intraocular surgery
* grade 2 or greater slit lamp findings
* currently pregnant or lactating
* more than 1.00D of refractive astigmatism in either eye
CAIman 5 Articulating Maryland in coloRECTAL Cancer Surgery

This voluntary study is part of a Post-Market-Surveillance plan to proactively collect clinical data for the use of Caiman 5 articulating Maryland in colorectal surgery under daily clinical routine.


Eligibility Criteria:
Inclusion Criteria:

* Patient´s written informed consent
* Planned laparoscopic colorectal cancer surgery using Caiman 5 articulating Maryland (according to the IfU)
* Age ≥18 years

Exclusion Criteria:

* Emergency surgery
* Pregnancy
* Participation in another surgical study, which might influence the intraoperative process
* Conversion to open surgery
* Conversion to another sealing / cutting instrument (instead of Caiman 5 articulating Maryland)
A Comparison of LMA-Supreme and I-gel for the Incidence of Postoperative Sore Throat

The purpose of this study is to investigate and compare the incidence of the postoperative sore throat between LMA supreme and I-gel.


Eligibility Criteria:
Inclusion Criteria:

- adult patients aged over 19 years who are scheduled for elective surgery under general anesthesia using the laryngeal mask airway

Exclusion Criteria:

* Anticipated difficult airway
* Expected duration of surgery more than 4 hours
* body mass index more than 35 kg/m2
* pregnancy
* Upper gastrointestinal surgery or open abdominal surgery.
A Controlled Study to Investigate the Effect of Multi-wave Light Emitting Diode (LED) Bed on Blood Pressure and Endothelial Function

The objective of this multi-center study is to investigate the effect of a multi-wave LED light bed on blood pressure and endothelial function in pre-hypertensive and mildly hypertensive adults.

Subjects will be instructed to lay in the bed for 20 minutes on their stomach followed by 20 minutes on their back for a total of 40 minutes three times per week for 8 weeks. Subjects will be instructed to begin light treatment on Day 1 after baseline measurements have been collected. Subjects will be required to visit a Wellness Center of Dr. Bryan or Hypertension Institute in Nashville, informed of the study and if agreed will sign the consent form. After consent, subjects will be required to spend about 30 minutes to get baseline measurements. Subjects will then be required to lie in bed for 40 minutes each day three days per week for 8 weeks. Blood pressure and endothelial function tests will be recorded at baseline and after each light treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male or female of 18-75 years of age
* If female, subject is not of child bearing potential
* Subjects with seated resting systolic blood pressures between 130-160 mmHg and diastolic between 85-100 mmHg (inclusive) at screening visit
* Subjects with mild to moderate endothelial dysfunction
* Agreement to maintain current level of physical activity and diet throughout the study
* Agrees to comply with study procedures including abstain from coffee at least 14 hours before blood pressure measurement and abstain from physical exercise at least 4 hours before blood pressure measurement
* Has given voluntary, written, and informed consent to participate in the study

Exclusion Criteria:

* Females who are pregnant, breastfeeding, or planning to become pregnant during the course of the study
* Seated office systolic blood pressure outside of the target range (systolic blood pressure \<130 mmHg or \>160 mmHg) or diastolic blood pressure \<85 or \>100 mmHg at screening
* The use of natural health products for the treatment of hypertension within 2 weeks of screening
* Significant cardiac history defined as a history of myocardial infarction (MI); coronary angioplasty or bypass graft(s); Valvular disease or repair; unstable angina pectoris; transient ischemic attack (TIA); cerebrovascular accidents (CVA); congestive heart failure; or coronary artery disease (CAD)
* Type I diabetes
* Unstable medical conditions that in the opinion of the Principle Investigator preclude the subject from participating in the study
* Alcohol or drug abuse within the last 6 months
* Participation in a clinical research trial within 30 days prior to randomization
* Individuals who are cognitively impaired and/or who are unable to give informed consent
* Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
Impact of Expressive Touching During Embryo Transfer

Infertile individuals report psychiatric symptoms and that their levels of anxiety and depression are significantly higher than in fertile controls .Thus,this study aimed to determine the effect of expressive touching during embryo transfer on the anxiety and pregnancy rate.


Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of primary infertility,
* Being over the age of 25 and under the age of 35
* Able to read and write Arabic,
* Women who will be applied assisted reproductive techniques such as IVF- ICSI-ET,
* Women with the same drugs and protocols used in IVF treatment was included in the study.

Exclusion Criteria:

* Women who have problems in understanding and perception,
* Having a diagnosis of secondary infertility wasn\&amp;#39;t included in the study
The Effect of Informative Letters on the Prescription and Receipt of Seroquel

Abusive prescribing exposes patients to unnecessary health risks and results in wasteful public expenditures. This study will evaluate an innovative approach to fighting abusive prescription: sending letters to suspected inappropriate prescribers warning them that they are outliers compared to their peers and have been flagged for review. The study will target high prescribers of Seroquel (Quetiapine), an atypical antipsychotic. Using claims data, the investigators will assess the effect of the letters on prescribing of Seroquel, receipt of Seroquel by patients, substitution behavior by prescribers and patients, and health outcomes of patients.


Eligibility Criteria:
Inclusion Criteria:

* General care practitioner
* Outlier with respect to the count of Seroquel prescription drug treatments relative to peer group of prescribers in 2013 and 2014
* Outlier with respect to the count of Seroquel 30-day equivalent prescription drug treatments relative to peer group of prescribers in 2013 and 2014

Exclusion Criteria:

* Deceased
Cardiopulmonary Resuscitation Witnessing by a Relative

The bereavement generated by the loss of a family member can induce pathological situations: depressive state, anxiety, post-traumatic stress disorder and complicated grief. These morbid factors can be influenced by the death circumstances and in particular by the possibility given to the family to attend the medical management of the patient. This clinical trial aims to evaluate the psychological consequences of bereavement on the relatives according to the possibility of witnessing the cardiopulmonary resuscitation of a family member. This possibility lies within the scope of a strategy of global management of the relatives.

This clinical trial aims to compare the presence of post-traumatic stress disorder on a relative related to the death of a family member:

Test group: the medical team will propose to the relative to witness the cardiopulmonary resuscitation.

Control group: the medical team will not modify its usual management of care.

Eligibility Criteria:
Inclusion Criteria:

* Patient victim of a cardiac arrest and resuscitation initiated
* Occurrence of cardiac arrest at home
* Presence of a relative :

  * husband or spouse
  * father or mother
  * son or daughter
  * brother or sister
* Patient's age ≥ 18 years
* Relative's age ≥ 18 years
* Consent of the relative to the participation in the study

Exclusion Criteria:

* No understanding of the explanations (language problem, important agitation)
* Non-affiliated to social security
Functional Assessment in Liver Transplantation

In order to ensure the equity of the liver allocation process, it is important to create objective, scientifically validated markers of frailty in patients with end-stage liver disease that accurately predict patient outcomes. Many measures have been developed to assess this clinical state in elderly patients, but none have been applied to patients with cirrhosis, a population at increased risk for accelerated functional decline. This protocol is designed to learn more about the effects of functional status (also known as "frailty") in liver transplant patients and patient outcomes both before and after liver transplant.

Subjects in this study will be asked questions regarding functional status and ability to do activities at home. Subjects will also be asked to complete several physical tests to assess functional status. For example, subjects will be asked to stand up from a chair several times, balance with their feet together, and walk down a hall as quickly as possible. Subjects will also be asked to perform a hand grip strength test.

Subjects will be assessed at baseline and at every clinic visit in the pre-transplant setting. Subjects will again be assessed at 3, 6, and 12 months post-transplant.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years old)
* Listed for liver transplantation, or are "listable" - i.e, have undergone formal evaluation and been approved for listing if/when patients achieve high enough priority
* Are seen in the outpatient clinic setting

Exclusion Criteria:

* Have severe hepatic encephalopathy at enrollment (defined by the time to complete the Numbers Connection Test (NCT) \> 120 seconds, which is the first test that the participants complete upon enrollment).
Intraoperative ERCP Versus Therapeutic Splitting in Cholecysto-, Choledocholithiasis

At the Kepler University Hospital Linz all variants of ERCP (preoperative, intraoperative, postoperative ERCP) are performed in cases of simultaneous cholecysto- and choledocholithiasis. Hardly any other hospital in Austria prefers intraoperative ERCP or offers it at all. A standardized procedure with implemented logistics has been established. This study compares intraoperative and postoperative ERCP.

At the Kepler University Hospital Linz all variants of ERCP (preoperative, intraoperative, postoperative ERCP) in cases of simultaneous cholecysto- and choledocholithiasis are performed. Usually an intraoperative ERCP followed by a preoperative ERCP is preferred. At the Kepler University hospital a high level of expertise in endoscopy and an interdisciplinary endoscopy team (surgical and internal medicine department) makes this high level of effort possible. Hardly any other hospital in Austria prefers intraoperative ERCP or offers it at all. A standardized procedure with implemented logistics has been established.

The aim of this study is to demonstrate and compare the advantages of both procedures at KUK from 1.1.2020 to 30.6.2023 (intraoperative and postoperative ERCP) in terms of morbidity, endoscopic success and the better way for patients and surgeons in clinics.

Eligibility Criteria:
Inclusion Criteria:

* simultaneous cholecysto-, choledocholithiasis
* emergency or elective
* confirmed choledocholithiasis
* intraoperative ERCP
* preoperative ERCP followed by cholecystectomy
* postoperative ERCP

Exclusion Criteria:

- \< 18 years
Chlorhydrate of Ropivacaine and Breast Cancer Surgery

The aim of the study is to evaluate the effect of local anesthetic (chlorhydrate of ropivacaine) to prevent chronic pain after breast surgery for cancer.

An estimated 20-65% of women treated with breast surgery for breast cancer experience chronic pain in the treated breast. Patients will be randomize between: infiltration with chlorhydrate of ropivacaine at the time of breast surgery for cancer versus placebo.Intra-operative analgesia will be standardized as well as peri-operative pain management.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients treated by conservative surgery with axillary node dissection or treated by mastectomy with or without axillary node dissection or sentinel lymph node biopsy.
* ASA physical status 1, 2 or 3
* With a minimum life expectancy of 2 years
* Written informed consent

Exclusion Criteria:

* Any previous cancer other than breast cancer
* Allergies to local anesthesic and morphine
* Reported history of drug
* Pregnancy
* Homolateral breast surgery during the last 3 years
* Analgesic use pre-operatively
* Renal, pulmonary or liver major dysfunction
* Active malignant disease
* Unable to follow the protocol for any reason
Augmented Endobronchial Ultrasound (EBUS-TBNA) With Artificial Intelligence

To evaluate the usefulness of Deep neural network (DNN) in the evaluation of mediastinal and hilar lymph nodes with Endobronchial ultrasound (EBUS). The study will explore the feasibility of DNN to identify lymph nodes and blood vessel examined with EBUS.

Multi-center prospective feasibility study. The DNN model will be trained on ultrasound images with annotation to identifies lymph nodes and blood vessels examined with EBUS. The ability of the DNN to segment lymph nodes and vessels based on postoperative processing and static EBUS images will be evaluated in the first part of the study. In the second part of the study Real-time use of DNN in EBUS procedure will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Subjects referred to thoracic department in any of the participating hospitals with undiagnosed enlarged mediastinal and hilar lymph nodes.
* Subjects have to be ≥ 18 years of age

Exclusion Criteria:

* Pregnancy
* Any patient that the Investigator feels is not appropriate for this study for any reason.
Improving Information to Caregivers Via Adaptation and Implementation of the HERMES Intervention

The HERMES intervention was developed in a Danish setting after a comprehensive investigation on caregivers' needs. The intervention consists of: 1) a systematic identification of the caregiver's unmet information needs and 2) a subsequent consultation with a nurse providing the lacking information. The evaluation carried out in a randomized trial at Herlev Hospital showed positive results. It reduced the unmet information needs and improved the caregivers' evaluation of the information from and communication with the health care professionals and the perception of being seen and acknowledged as a caregiver. However, although research projects may show a positive effect, this does not mean that the intervention will be easily implemented in the health care system. Nor does it guarantee that the intervention will show the expected results once implemented in a busy clinical routine.

Therefore, the present project will adapt the HERMES intervention to be implemented in Danish departments of oncology and haematology by (in the first part of the project):

1. Elucidating how the HERMES intervention is best implemented in the clinical setting according to the clinical staff.
2. Elucidating how the HERMES intervention is best implemented in the treatment and follow-up period according to the patients and their caregivers.
3. Developing a technological solution (an app) for the HERMES intervention in which the responses given by the caregivers will form the basis for a subsequent consultation with the health care staff.
4. Revising the HERMES intervention based on the outcomes of a-c.
5. Testing the revised HERMES intervention in a pilot study.

In the second part of the project, the revised HERMES intervention will be tested in a large scale trial with the purpose to:

1. Implement the revised HERMES intervention in the departments of oncology/haematology.
2. Test the effect of the revised HERMES intervention.
3. Evaluate the feasibility of the revised HERMES intervention in a large scale.
4. Elucidate the effectiveness and the feasibility of the intervention and assess possibilities and potential needs for further adaptation in order to secure the future applicability in the Danish Health Care System.

Thus, the overall aim is that by the end of the study, an evidence based and practical implementable method to (continous) use of the HERMES intervention in the Danish health care system is available.


Eligibility Criteria:
Inclusion Criteria:

* Adult (18+ years)
* Primary caregiver (defined as the lay person (partner, family member, friend, etc) most involved in the patient's disease course. The primary caregiver is appointed by the patient)
* Caregiver of an adult cancer patient starting up a treatment course in an oncological department
* Written informed consent to participation

Exclusion Criteria:

* Caregivers not able to read and understand Danish
* Caregivers with no or minimal contact to the oncological department
The Interrelation of the Vasculature, Endothelium, Bone Metabolism and Uremic Toxins in Peritoneal Dialysis

Despite major advances in the treatment of chronic kidney disease, the age and sex matched mortality far exceeds that of the normal population. As in the normal population, the majority of deaths are related to cardiovascular disease. Mounting data point to the lethal synergy between chronic kidney disease and cardiovascular disease. This relation is present from early stages of chronic kidney disease on.

Several uremic toxins have been demonstrated to play an important role in kidney disease related endothelial dysfunction. In peritoneal dialysis patients, data on the relation between uremic toxins, endothelial dysfunction and microparticles are lacking.

The investigators hypothesize that endothelial dysfunction and uremic toxins are interrelated in peritoneal dialysis patients


Eligibility Criteria:
Inclusion Criteria:

* age \> 18
* Maintenance peritoneal dialysis

Exclusion Criteria:

* No informed consent
* Peritonitis
Dietary Supplements to Treat Radiation-Induced Rectal Injury

This clinical study is a prospective, single-arm, single-center trial aimed at assessing the safety and efficacy of tributyrin (TB) as dietary supplements in the treatment of chronic radiation-induced rectal injury (RRI). We hypothesize that these supplements will help improve rectal bleeding symptoms and elevate the quality of life for patients. The study will test whether the supplements can lower the LENT-SOMA scales of rectal bleeding and enhance overall patient health. Efficacy will be evaluated through blood tests and other non-invasive methods, ensuring patient safety and comfort throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* At least 3 months since the completion of pelvic radiotherapy
* No evidence of tumor recurrence or metastasis
* Rectal bleeding with grade 1-2 by LENT-SOMA scales

Exclusion Criteria:

* Acute or chronic infectious diseases
* Serious systemic diseases
* Known allergies to any components of the study medication
* Colonoscopy indicating rectal ulceration (\>1cm2), fistula, stricture, or necrosis
* Late complications related to pelvic radiation injury
* Other hemorrhagic or coagulation disorders
* Previous rectal resection
* Bowel obstruction or perforation that require surgery
* Cognitive or psychological disorder
* Contraindications to FMT administration
A Pharmacist Implemented Pharmacogenomics Service in the Program of All-inclusive Care for the Elderly

The aim of this study is to evaluate and describe the feasibility of implementing a pharmacist-led pharmacogenomics service for the Program of All-inclusive Care for the Elderly (PACE), a community-based practice setting.

To determine if a pharmacogenomics (PGx) service can become a component of everyday practice, feasibility assessments are needed. While some researchers have begun to assess the feasibility of implementing PGx into pharmacy practice in community-based practice settings, none that we are aware have assessed such feasibility for the Program of All-inclusive Care for the Elderly (PACE). The primary objective of this feasibility study is to evaluate the processes that were involved in implementing a pharmacist-led PGx service for PACE and to describe process-related challenges and solutions associated with implementation. Secondary objectives include: describe pharmacists' roles in the implementation process; report aggregate PGx test results, including genetic variants and drug-gene interactions; and describe pharmacists' recommendations to personalize drug regimens for PACE participants and prescribers' acceptance of these recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Participant enrolled in PACE contractually receiving pharmacy services from Tabula Rasa Healthcare (CareKinesis Pharmacy) during the project time period (May 2014 through June 2016); and
* PACE prescriber ordered a pharmacogenomics test for the participant as part of clinical care; and,
* PACE participant consented to a pharmacogenomics test; and,
* CareKinesis pharmacist provided a consultation directly to PACE prescriber based on the participant's pharmacogenomics test results.

Exclusion Criteria:

* Participant dis-enrolled from PACE prior to receiving pharmacogenomics test results and/or prior to CareKinesis pharmacist providing consultative services; or,
* Participant did not complete the pharmacogenomics test.
Percutaneous Vertebroplasty Using Rotary Cutter for Bone Metastases

Percutaneous vertebroplasty has been applied widely to treat bone metastases. The injected cement may strengthen the affected bone to prevent pathological fractures and relieve the pain. Moreover, the thermal reaction (70°C) due to polymerisation of cement also contributes to tumour destruction. The cement dose and diffusion pattern may be significant factors for the treatment efficacy, which can be affected by the inner pressure of the metastases. The investigators will apply a rotary cutter to destroy the structure of metastases to alleviate the pressure in the metastases. Then, more cement will be injected, which may effectively interdigitates with the surrounding bone and generate more thermo to kill the tumor cells.


Eligibility Criteria:
Inclusion Criteria:

1. Imaging-proven and pathology-proven metastases
2. Intractable pain with neurologic dysfunction

Exclusion Criteria:

1. Poor general condition without tolerance of surgery