cyrilzakka/clinical-trials huggingface dataset:
The Effect of Running Water Sound Listened to Patients During Hemodialysis

It is known that being in nature and the visual perception of nature positively affects an individual's mood and self-confidence. Studies have reported that natural sounds have a positive effect in situations such as pain, anxiety, and stress. This finding means that listening to natural sounds may be a simple and easily accessible intervention that can positively impact key human stress systems.

Although many non-pharmacological methods are used in the literature to reduce the invasive pain and anxiety experienced by hemodialysis (HD) patients during cannulation, the most popular recently; However, we aimed to determine the effect of the sound of running water, which we have not yet encountered in dialysis patients, on invasive pain and anxiety experienced during fistula access.

In this study; Between 15 December 2023 and 15 March 2024, patients receiving dialysis will be included in the Dialysis Service of two hospitals in western of Turkey which havedialysis for 3 days a week.

The sample calculation was determined using power analysis based on a previous study. (Çetinkaya, Karabulut (2010). The sample size of the study was calculated as at least 30 patients, for each group that met the sampling criteria. The population of the research was determined as 74 people. The number of patients who met the inclusion criteria was 68, and these patients were assigned to the experimental (34 patients) and control (34 patients) groups by an independent statistician with the help of a computer program (randomizer.org).

Patients over the age of 18, who are volunteers, who undergo dialysis 3 days a week, who do not have any communication problems and who do not use any psychiatric medication will be included in the study. Patients who do not meet the inclusion criteria will be excluded from the study.

Dialysis sessions are held 3 days a week, between 08.00-16.00, on Mon-Wed-Fri and Tuesday-Thurs-Sat.

All patients who volunteer to participate in the study will be included in the study. During the cannulation process, the experimental group will listen to the sound of flowing water throughout the process with the help of the researcher's smartphone. VAS scale will be applied to the experimental and control groups after each cannulation, and the State and Trait Anxiety Scale will be applied before the first dialysis session and after the 12th session. The control group will receive standard care. A total of 12 sessions will be followed in both groups.

Eligibility Criteria:
Inclusion Criteria:

* between 18 - 65 years
* not have communication problem
* Patients receiving dialysis 3 days a week
* Have cannulation

Exclusion Criteria:

* under 18- over 65 years
* Have communication problems
* Not have dialysis 3 days a week
* Have not cannulation
IV Ibuprofen vs Ketorolac in Post Operative Pain in Colorectal Cancer Surgeries in Obese Patient

The aim of this study is to assess the Efficacy of IV Ibuprofen and Ketorolac in the Management of Postoperative Pain in obese patients Following abdominal cancer surgery.

Colorectal cancer is the third most common cancer in the world, after lung and breast cancer, and the 4th most reported cause of cancer death, reporting about 8.0 % of all cancer deaths According to the WHO, Egypt was ranked the 18th regarding the prevalence of obesity, and Deaths attributable to non-communicable diseases represent about 71% of the total mortality burden.Data obtained from the past 25 years suggest that the obesity is a cause of nearly 14% of cancer deaths in men and up to 20% of cancer deaths in women. Most of cases experience moderate to severe pain after colorectal surgery, So effective and individualized analgesia required after colorectal surgery, as pain response to surgery is not predicted.

Opioids are an effective analgesic for moderate to severe pain, although their efficacy is limited by adverse effects including respiratory depression, failure to reduce pain caused by tissue inflammation, nausea, emesis, drowsiness, moderate sedation, pruritus, urinary retention and ileus.

Regional anesthesia can be an alternative to opioids but according to multiple studies it was associated with technical difficulties and higher failure rates in obese patients. Ibuprofen is a nonselective inhibitor of cyclooxygenases (COX) enzymes, the inhibition ratio of COX-1 to COX 2 of Ibuprofen is 2,5:1 that has a low risk of bleeding or gastrointestinal problems, while other NSAID as for example ketorolac have an inhibition ratio of 330:1 for COX-1 to COX-2 , reason for a high risk of side effects , therefore its use is controversial in most of perioperative settings. ketorolac 10 and 20 mg and ibuprofen 400 mg have the same analgesic effect that was significant by hour 1 and persisted for 5-6 hours for each active medication.

Eligibility Criteria:
Inclusion Criteria:

* ASA class II.
* Age ≥ 18 and ≤ 65 Years.
* Patients undergoing midline abdominal incision for colorectal cancer surgery.
* Body mass index (BMI) \>30 kg/m2.

Exclusion Criteria:

* Renal and hepatic insufficiency.
* Unstable cardiovascular disease.
* History of psychiatric and cognitive disorders.
* Patients allergic to medication used.
* Asthmatic patients.
* Peptic ulcer patients.
* patients on regular opioid consumption.
* History of allergy or hypersensitivity to any component of ibuprofen, other NSAIDs, opioids or COX- 2 inhibitors.
* Subjects with active significant anemia, history of asthma .
Melatonin Replacement Therapy in Pinealectomized Patients

This is an open-label, single-arm, single-center, proof-of-concept study to assess the effects of melatonin on cardiac autonomic activity in melatonin non-proficient pinealectomized patients.

This is an open-label, single-arm, single-center, proof-of-concept study to assess the effects of melatonin on cardiac autonomic activity in melatonin non-proficient pinealectomized patients. The study consists of a screening period, followed by a 3-month melatonin treatment period, and a 6-month washout follow-up period. Adverse events were monitored with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the event.

Eligibility Criteria:
Inclusion Criteria:

* patients with pinealectomy and all of the following criteria were considered for admission to the clinical trial:
* children, adolescents and young adults 0 months to 25 years of age;
* signed written informed consent (patient or his/her parents/legal guardian);
* willing and able to complete the clinical trial procedures, as described in the protocol
* no recurring tumor after pinealectomy and subsequent chemotherapy
* absence of circulating melatonin evaluated by salivary melatonin Elisa assay

Exclusion Criteria:

* patients with cardiac arrhythmias
* potentially non-compliant subjects judged by the investigator to be unsuitable for the study
Registration Trial of the Drug-coated Balloon for the Symptomatic Cerebral Atherosclerotic Stenosis

The purpose of the trail is to determine whether DCB is superior to conventional balloon in treating cerebral atherosclerotic stenosis


Eligibility Criteria:
Incsion Criteria:

* Age 18 to 80 years old at informed consent signing.
* Symptomatic atherosclerotic stenosis of cerebrovascular arteries with ≥70% stenosis.
* Medication ineffective.
* modified Rankin Scale(mRS) score≤2.
* The subject or guardian is able to understand the purpose of the study, is willing to participate and has given written informed consent.

Exclusion Criteria:

* History of acute ischemic stroke within 2 weeks;
* Stenosis due to non-atherosclerotic lesions such as arterial dissection, Moya-Moya disease and vasculitic disease;
* Target vessels complete occlusion or with thrombus in target vessels;
* Target vessel with severe calcification or distortion that making interventional device is difficult to place;
* History of stenting in the target artery;
* Target vessel restenosis following stenting or balloon angioplasty;
* Combined with other lesion with ≥70% stenosis in target vessel.
* Residual stenosis ≥50% or vessel dissection with obvious blood flow restriction occurs after predilation.
* Combined with intracranial tumour, arteriovenous malformation or aneurysm of the target vessel.
* History of intracranial hemorrhage within 90days.
* Presence of severe systemic diseases that cannot tolerate surgery, such as severe liver and kidney dysfunction;
* Contraindication to the use of anticoagulants and antiplatelet agents, such as sllergy to anticoagulants and antiplatelet agents, active bleeding or coagulation disorders;
* Allergic to contrast agents or rapamycin;
* Pregnant or lactating women;
* Participating or intending to participate in any other drug/device clinical trials;
* Life expectancy \<1 year;
* Any other conditions that the investigator deems the patient unsuitable for enrollment.
Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes

To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.

To examine the long-term (52 weeks of treatment) safety and effect on glucose control of exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Diagnosed with type 2 diabetes mellitus
* HbA1c 7.1 to 11%, inclusive, at screening
* Fasting plasma glucose \<280 mg/dL (15.5 mmol/L)
* Body mass index (BMI) \<=45 kg/m2, inclusive, at screening
* Treated with diet and exercise or a stable regimen of metformin, sulfonylurea, pioglitazone or any 2 of these agents

Exclusion Criteria:

* History of pancreatitis or triglycerides \>=500 mg/dL
* Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either
* Active cardiovascular disease
* Presence of congestive heart failure
* Liver disease
* History of severe gastrointestinal diseases
* Repeated severe hypoglycemia within the last 6 months
* Any previous use of exenatide or other glucagon-like peptide-1 (GLP-1 ) analog
* Dipeptidyl peptidase-4 (DPP-4) inhibitor use in the last 3 months
To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy Volunteers

The purpose of this study is to evaluate the relationship between plasma drug levels and receptor binding in brain using PET; and to evaluate safety and tolerability after a single administration of PF-04995274 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* healthy male and/or female subjects of nonchildbearing potential between the ages of 18 and 55 years, inclusive

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening
* Fulfillment of any of the MRI contraindications on the standard radiography screening questionnaire
SUbstrate Ablation in Persistent Atrial Fibrillation for Elimination of Recurrences (SUPAFER).

Antecedents: electrical isolation of pulmonary veins is the standard treatment for patients with atrial fibrillation. However, its efficacy is lower in persistent and chronic forms of this arrhythmia compared to paroxysmal atrial fibrillation. Many complementary techniques have been proposed, that added to pulmonary veins isolation, may reduce the recurrence rate of atrial fibrillation. However, none of them has obtained consistent results. Linear ablation aims to parcellate and modify the left atrial substrate responsible for atrial fibrillation maintenance. Previous studies have offered contradictory results using linear ablation.

Methods: SUPAFER is a multicenter, 1:1 randomized clinical trial that compares the efficacy of pulmonary veins isolation alone vs pulmonary vein isolation plus an specific protocol of left atrial linear ablation. Contrary to previous studies, the specific SUPAFER linear ablation is systematic, homogeneous and target atrial areas that have not been systematically ablated in previous trials. The trial aims at demonstrating the superiority of the combined ablative approach during 1-year follow-up. Daily transtelephonic ECG samples a 30 days continuous ECG monitoring are used to maximize de detection of recurrences, even asymptomatic.


Eligibility Criteria:
Inclusion Criteria:

* Persistent atrial fibrillation documented with electrocardiogram and defined as: persistent (continuous AF duration \>1 week) or long-lasting persistent (continuous AF duración \>1 year).
* One of the following additional criteria: 1)symptomatic AF, 2)recurrence despite antiarrhythmic drugs or after electrical cardioversion, 3)tachymiopathy, 4)heart failure, 5)antiarrhythmic drugs either not tolerated or rejected or considered inadequate by the patient or an electrophysiology specialist, 6)preference for ablation explicitly manifested by the patient.
* Age \>=18 years and written informed consent.

Exclusion Criteria:

* AF with a reversible cause.
* Previous pulmonary veins isolation or left atrial linear ablation.
* Cardiac surgery, acute coronary syndrome, percutaneous coronary intervention o ischaemic stroke \<1 month before ablation.
* Intracranial haemorrhage \<3 months before ablation.
* Ablation contraindicated due to 1)absolute contraindication for oral anticoagulants, 2)persistent atrial thrombus, 3)pregnancy, 4)extreme fragility and 5)life expectancy \<1 year.
Mindfulness for Pediatric Chest Pain

The goal of this clinical trial is to test mindfulness practices in children with idiopathic chest pain, which is chest pain that does not have a known cause. The main question this study aims to answer is whether children who experience idiopathic chest pain are able to follow a mindfulness program. This study also aims to determine whether mindfulness affects the way children with idiopathic chest pain cope, and if it affects their stress levels, quality of life, frequency of chest pain episodes, and chest pain intensity.

Participants will:

* Complete a survey at the beginning of the study that asks questions about their sex, ethnicity, and history of chest pain and other chronic pains.
* Complete a short survey every day for the entirety of the study that asks about the number, intensity, and duration of chest pain episodes experienced that day.
* Complete 4 surveys, 2 weeks after they have been enrolled in the study: pain coping survey, perceived stress survey, quality of life survey, and mindfulness survey.
* Be randomly placed into either the control group or the mindfulness-based intervention group, 2 weeks after they have been enrolled in the study.
* Receive the standard of care for children with idiopathic chest pain, if they are placed into the control group.
* Use the mobile app Headspace to complete daily mindfulness sessions for the remaining 30 days of the study (starting after the initial 2 week period), if they are placed in the mindfulness-based intervention group.
* Complete 4 surveys at the end of the study: pain coping survey, perceived stress survey, quality of life survey, and mindfulness survey.
* Complete a mindfulness program evaluation survey at the end of the study, only if they are in the mindfulness-based intervention group.

Researchers will collect information from Headspace to see how well participants in the mindfulness-based intervention group are able to follow the mindfulness program. This will help guide future, larger studies that look at the effects of mindfulness-based interventions in children with idiopathic chest pain. Researchers will also compare survey results between the control group and the mindfulness-based intervention group to see if the mindfulness program affects the way children with idiopathic chest pain cope, as well as their stress levels, quality of life, frequency of chest pain episodes, and chest pain intensity.


Eligibility Criteria:
Inclusion Criteria:

* Patients whose primary complaint is recurrent chest pain that is diagnosed as idiopathic or musculoskeletal by a pediatric cardiologist.
* No acute illness.
* Normal ECG.
* Willing and able to download and use the Headspace application on a daily basis.
* Able to complete surveys in the English language.

Exclusion Criteria:

* Patients whose chest pain is secondary to pericarditis, arrhythmia, or structural heart disease.
* Patients with concurrent symptoms that could potentially interfere with the ability to determine the effect on their chest pain (e.g., palpitations or dizziness).
* Unable to provide informed assent.
CABG Without the Use of CPB

Comparison of clinical outcomes in patients undergoing coronary bypass surgery using the heart/lung machine as opposed to using off-pump techniques.


Eligibility Criteria:
Inclusion Criteria: Eligible for coronary surgery -

Exclusion Criteria: Less than 18 years Emergency and salvage operations

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Effects of Soft Tissue Mobilization Technique and Piriformis Muscle Stretching Among Patients Having Piriformis Syndrome

It is a randomized control trail in which soft tissue mobilization and piriformis stretching will be compared and study duration will be of five months

Piriformis syndrome is one of the misdiagnosed syndromes and there is no evidence available for the proper diagnosis of this syndrome. Several interventions have been adopted in the clinical setting for improvement of piriformis syndrome including therapeutic ultrasound, myofascial release, stretching, dry needling, strengthening exercises of hip muscles and activity modification. There are several treatments available for this syndrome but no comparison studies have been reported yet on soft tissue mobilization and piriformis muscle stretching. The purpose for conducting this research is to assist in establishing the effectiveness of soft tissue mobilization technique and piriformis muscle stretching in piriformis syndrome by comparison between two abovementioned treatments

Eligibility Criteria:
Inclusion Criteria:

* Males and females with age between 25 and 45 years
* Patients with positive piriformis test
* Pain at least 3 according to numeric pain rating scale (NPRS)

Exclusion Criteria:

* History of hip pain due to any diagnosed hip pathology
* Leg length discrepancy
* Past history of spinal surgery
* Spinal tuberculosis
* Rheumatoid disease,
A Study of Pimitespib in Combination with Imatinib in Patients with GIST (CHAPTER-GIST-101)

This study consists of Dose escalation part and Expansion part. In Dose Escalation Part, the maximum tolerated dose of combination of pimitespib and imatinib in patients with gastrointestinal stromal tumors (GIST) who are judged to be refractory to imatinib, estimate the recommended dose, evaluate safety and pharmacokinetics, and observe the antitumor effect. Expansion part consists of 3 arms. In Arm A, the efficacy and safety will be evaluated, which of the combination of pimitespib and imatinib in patients with GIST who have failed imatinib at doses below the MTD determined in Dose Escalation Part. In Arm B, the efficacy and safety of pimitespib monotherapy will be evaluated and the therapeutic effect of imatinib administration after pimitespib will be evaluated in an exploratory manner. In Arm C, the efficacy and safety of sunitinib monotherapy will be evaluated as reference data.


Eligibility Criteria:
Inclusion Criteria:

* Provided written informed consent
* Histologically confirmed GIST
* Has radiographic progression based on RECIST 1.1 during or within 6 months of the last imatinib administration at enrollment. If surgery/radiotherapy has been performed, radiographic progression based on RECIST 1.1 with imatinib must have been observed after the last surgery /radiotherapy
* Has at least one measurable lesion based on the RECIST version 1.1, except lymph nodes (not dependent on size), which should be chosen as nontarget lesions;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion Criteria:

* Corrected visual acuity \< 0.5 (using the International Visual Acuity Measurement Standard) for both eyes
* Received treatment with any other line of therapy besides imatinib for advanced GIST
* History of total gastrectomy and/or whole resection of the small intestine
* A serious illness or medical condition
* Previous or concurrent cancer that is distinct in primary disease or histology from cancer that is being evaluated in this study. However, any previous cancer curatively treated \> 5 years before the enrollment can be eligible
* Pregnancy or lactation (including lactation interruption)
Feasibility and Benefit of Laparoscopic Hysterectomy With Less Than 3 Millimeter Diameter's Instruments in Current Practice

Hysterectomy for benign uterine disease is often intended to young perimenopausal patients. Currently laparoscopic hysterectomy is commonly used in this indication. We are wondering if decreasing the diameter of laparoscopic instruments could reduce postoperative pain and improve esthetic result without increasing operative time. The purpose of the study is to improve patients' care.

That is why we propose a randomized comparative study between standard instrument and less than 3 millimeter diameter's instruments to achieve in daily practice laparoscopic hysterectomy.

The study will be unicentric, single-blind. Study period will be one year and 4 months. Patients will be enrolled in pre-operative consultations or at the weekly staff. They will have to sign an informed consent.

The day before surgery: patients will be randomized by the statistician. A resident will carry out a preoperative ultrasound to determine an estimated uterine volume. Nurses will make a blood test (hemoglobin).

The day of surgery we will assess: operative time, surgeon's ergonomics, the amount of bleeding, patient's pain at rest and mobilization.

At Day-1 post surgery nurses will make an other blood test (hemoglobin) and we will assess patient's pain at rest and mobilization.

At the postoperative consultation we will lister : complications (Accordion Severity score classification), esthetic result (PSAQ), patient's pain.

Eligibility Criteria:
Inclusion Criteria:

* patient candidate for total inter-adnexal hysterectomy or for hysterectomy with oophorectomy and
* benign gynecological pathology: fibroids, adenomyosis, polyps, dysfunctional uterine bleeding.

and

* affiliation to social security and
* informed consent

Exclusion Criteria:

* ASA III or IV patients,
* age\> 80 years old,
* history of major abdominal surgery by laparotomy
* severe obesity (BMI\> 35kg / m2)
* pathology of hemostasis and coagulation (liver disease, bleeding disorders)
* uterine volume estimated on preoperative ultrasonography \> 300 g
* minor patients,
* adult lacking legal capacity
* patients suffering from mental illness incompatible with informed consent, refusal to participate.
Study of the Cleavage of the Egg in Relation to the Stimulation Treatment

This post-marketing, single-center prospective study will be conducted in an open-label, non-interventional setting, for women seeking fertility treatment and will describe cleavage dynamics in relation to the age of the oocyte and gonadotrophin treatment.


Eligibility Criteria:
Inclusion Criteria:

1. IVF/ICSI treatment
2. Regular cycles of 25-35 days
3. Follicle stimulation with Bravelle and/or Menopur
4. Women aged 38-35 years
5. Long agonist or short antagonist treatment
6. Willing and able to understand a Danish, English or German patient information form
7. Willing and able to provide written Informed Consent

Exclusion Criteria:

1. BMI more than 35
2. Presence of hydrosalpinx on ultrasound
3. FSH more than 13 or antral follicle count (AFC) less than 4 at fertility investigation
4. Known allergic reactions to the planned medications
5. Use of testicular sperm