cyrilzakka/clinical-trials huggingface dataset:
Drains Ablation Post Total Hip Arthroplasty : Search for the Least Painful Technique

Comparison of ablation technique of drains


Eligibility Criteria:
Inclusion Criteria:

1. Patients admitted to the orthopedic surgery department for surgery for a total hip arthroplasty
2. Signed inform consent form

Exclusion Criteria:

1. Drain in non-aspirating mode at the time of medical ablation prescription
2. Administration of analgesic III in the 12 hours preceding the inclusion
Trial Comparing 3 and 4 Week Regimen of Gemcitabine and Cisplatin in Patients With Lung Cancer

The purpose of this study is to evaluate response rate of the 3 week versus 4 week treatment of gemcitabine with cisplatin as the first line treatment for non-small cell lung cancer patients in China.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of NSCLC
* Presence of Stage IIIB or Stage IV disease
* Patients must have received no prior systemic chemotherapy
* Patients must have at least one bi-dimensionally measurable lesion with clearly defined margins and two perpendicular diameters that are clearly measurable by any of the following: chest x-ray, with at least one diameter 1.0 cm or greater, CT, with both diameters greater than the distance between cuts of the imaging study, palpation, with both diameters 2.0 cm or greater, or disease progressing in areas of prior radiation therapy may be included
* No prior radiotherapy for the target organ, no other radiotherapy for at least 2 weeks prior to study enrollment and the patient must have fully recovered from all acute toxic effects of the treatment.

Exclusion Criteria:

* Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
* Are employed by Lilly (that is, employees, temporary contract workers, or designees responsible for the conduct the study). Immediate family of Lilly employees may participate in Lilly sponsored clinical trials, but are not permitted to participate at a Lilly facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
* Have previously completed or withdrawn from this study or any other study investigating gemcitabine.
Effect of Docosahexaenoic Acid on the Inflammatory Response and Clinical Outcomes From Surgical Patients

The purpose of this study is to evaluate if enteral docosahexaenoic acid (DHA) administration attenuates the inflammatory cytokines and improve clinical outcomes in neonates who underwent cardiovascular surgery

Severe sepsis and organ failure are leading causes of death in surgical patients. Several studies indicate that a causal relationship exists between the surgical or traumatic injury and the predisposition to develop septic/infectious complications and multiple organ failure; this is attributable to uncontrolled inflammatory response. Since neonates have an immature immune system, they are in a higher risk to develop uncontrolled inflammatory response and adverse clinical outcomes.

N-3 long chain polyunsaturated fatty acids (L-PUFAs) such as docosapentaenoic and docosahexaenoic acids (EPA and DHA) have been shown to reduce the inflammatory response by reducing cytokines, infection rates and length of hospitalization in patients with abdominal surgery. Therefore, acute and enteral administration of DHA may improve clinical outcomes in neonates with cardiovascular surgery

Eligibility Criteria:
Inclusion Criteria:

* Authorization from both parents for recruiting of the neonate into the study with consent signed form after the purpose and procedures have been explained
* Gestational age older than 32 weeks
* Adequate weight for gestational age
* Gastrointestinal tract that allows tolerate the doses of DHA or placebo
* No signs of Systemic Inflammatory Response Syndrome before the surgery as fever \>38 degrees C or hypothermia \<36 degrees C, or leukocytosis \>19,500 cells/cubic mm or \< 5000 cells/cubic mm or \> 10% immature forms.

Exclusion Criteria:

* Fasting for more than two days after surgery
* Discharge to other hospital outside the metropolitan area
* Parents who decide to decline of the study
* Patients who necessitate cardiovascular bypass
Anxiety Level Among Patients With Chronic Low Back Pain

The goal of this observational cross-sectional study is to learn about the intensity of anxiety symptoms among Polish people suffering from chronic lower back pain. The main question it aims to answer is:

What is the severity of anxiety symptoms among the Polish population of patients suffering from chronic lower back pain?


Eligibility Criteria:
Inclusion Criteria:

* age minimum 18 years old
* chronic low back pain (duration longer than 3 months)
* native Polish speaker
* people who gave informed consent to participate in the study

Exclusion Criteria:

* trauma/ surgery on the low back within the past one year
* diagnosis of severe mental illness
* pregnant within the past one year
A Clinical Trial Evaluating the Efficacy of a Skin Cream in Improving Facial Appearance and Skin Elasticity

A Clinical Trial Evaluating Efficacy of a Skin Cream Targeting Dermal Fat in Improving the Skin Elasticity of Healthy Volunteers.

This is a single-arm study with subjects serving as their own controls. The study evaluates a face cream comprised of natural agents with adipogenic and lipolytic activities. The combination of adipogenic and lipolytic impulses is theorized to be more effective in promoting regeneration and healthy cell size in the dermal white adipose tissue than other approaches (e.g., adipogenic + lipogenic or anti-adipogenic + lipolytic). The health of the dermal white adipose tissue is reflected by the strength and elasticity of the skin and the distribution of volume in the face.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Plans to undergo facial skin resurfacing (e.g. laser, chemical peel, microneedling) during the study period
* Plans to undergo injectable filler treatment.
IVIG Treatment for Refractory Immune-Related Adult Epilepsy

The purpose of the initial screening study is to find out if immune problems are an unrecognized cause of epilepsy in some patients. This study consists of a single blood sample, which will be tested for possible immune abnormalities. If enough patients are found who show immune abnormalities, those patients who are still having uncontrolled seizures will be invited to participate in a study of immune treatment with a compound called intravenous immunoglobulin (IVIG).

The study hypothesis is that a significant proportion of the young-onset, refractory, image-negative, partial-onset epilepsy population have an underlying autoimmune disorder, and many of these patients will respond to immune therapies, including IVIG.

At present, the importance of immune abnormalities in causing epilepsy, and the proper treatment when they are found, are both poorly understood. The investigators hope that this study will help us understand the cause of some cases that are difficult to treat.

The study is divided into two phases:

Phase I: The investigators will screen for evidence of neuronal nuclear, cytoplasmic, and cell surface autoantibodies in our population of new onset refractory, imaging-negative young adult epilepsy patients. This part of the study involves obtaining a single blood sample, equal to about 2 teaspoons.

Phase 2: If a sufficient number of cases are identified, a double-blind crossover study of IVIG treatment will be performed in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of uncontrolled epilepsy with at least two seizures a month for three consecutive months.
* Age 18 to 50.
* Clinical semiology or electroencephalogram (EEG) consistent with partial onset epilepsy.
* Refractory to an adequate trial of two or more main-line anti-epileptic drugs.
* Ability to keep a seizure diary.
* Normal brain magnetic resonance imaging (MRI) - 3 Tesla, seizure protocol; with the exception of hippocampal sclerosis

Exclusion Criteria:

* History of severe prematurity or neonatal distress, febrile seizures, moderate or sever traumatic brain injury, stroke, brain tumor, meningitis, encephalitis, neurocutaneous syndromes, or intracranial metal objects.
* Evidence of psychogenic epilepsy.
* History of convulsive status epilepticus.
* History of primary generalized epilepsy in a first degree relative.
* Known serious medical illness.
Is The Sudden Onset of Dizziness A Symptom of Acute Liver Dysfunction?

Dizziness is one of the most common complaints among patients admitted to the emergency department (ED). In most cases, the etiology remains unclear. Dizziness has a broad differential diagnosis. The initial symptoms of ALD can include many general complaints. Aim of this study is to investigate whether SOD is a symptom of ALD, the necessity of liver function tests for patients with SOD in the ED, and a cost analysis of liver function tests.

Dizziness is one of the most common complaints among patients admitted to the emergency department (ED). In most cases, the etiology remains unclear. Dizziness has a broad differential diagnosis. The initial symptoms of ALD can include many general complaints. The diagnosis of acute liver dysfunction (ALD) can usually be made by initial symptoms, physical examination, and biochemical tests, including liver function tests (LFTs) with high sensitivity and specificity. LFTs include albumin, bilirubin, coagulation factors (Activated Partial Thromboplastin Time (aPTT) and International Normalized Ratio (INR)), and liver enzymes, such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphates (ALP), and y-glutamyl transpeptidase (GGT), which are marker of hepatic damage. Aim of this study is to investigate whether SOD is a symptom of ALD, the necessity of LFTs for patients with SOD in the ED, and a cost analysis of LFTs.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients who were experiencing sudden onset dizziness of unknown etiology for the first time were included in the study

Exclusion Criteria:

1. Patients with a history of chronic diseases such as any liver disease,diabetes mellitus, hypertension,congestive heart failure, hepatitis B or C infection
2. Patients with any central dizziness attacks
3. Patients with hemodynamically unstable and emesis;
4. Patients receiving drugs that could affect liver function tests, such as, acetaminophen, antibiotics, oral contraceptives, antihypertensive drugs (e.g., angiotensinconverting enzyme inhibitors), or hormones (e.g.,estrogen)
5. Patients who was experienced dizziness with systemic diseases
6. Patients with any neurological disorders
7. Patient who do not want to participate in the study
Effect of Food and Antacid on BIIB021 With Advanced Solid Tumors

This study is designed to assess the effect of food and antacid use on the pharmacokinetic properties of BIIB021.

This study has 2 phases (the Food Phase and the Antacid Phase), each consisting of a 2-period, 2-sequence, 2-treatment crossover design. The Food Phase will assess the effect of a high fat meal on the pharmacokinetics of 100 mg BIIB021, and the Antacid Phase will assess the effect of an antacid (ranitidine) on the pharmacokinetics of 450 mg BIIB021 in the same subjects. Ranitidine 150 mg will be taken the evening before and the morning of the antacid dosing day.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with histologically or cytologically confirmed solid tumors who have failed or are not candidates for standard therapies or for whom no approved therapy is available.
* Eastern Cooperative Oncology Group (ECOG) performance status of greater or equal to 2.
* Medically able to tolerate a high fat meal and to fast as per protocol.
* Expected survival time of at least 3 months in the opinion of the Investigator.
* Ability to take ranitidine as per protocol.
* Must be able to swallow and retain oral medication.
* Lab values consistent with adequate renal, hepatic, and bone marrow functions.
* Electrocardiogram (ECG) with QTc of ≤450 msec for men or ≤470 msec for women and no clinically significant findings.

Exclusion Criteria:

* Pregnant (positive pregnancy test) or nursing women.
* Previous treatment with an Hsp90 inhibitor.
* Use of antacids within 7 days of Study Day 1.
* Prior antitumor therapies, including prior experimental agents or approved antitumor therapies within 28 days of the first dose of BIIB021.
* Major surgery or radiation within 28 days of the first dose of BIIB021.
* Uncontrolled, severe medical illness, which in the opinion of the Investigator and/or Sponsor could compromise protocol objectives.
* History of gastrectomy or major surgery to small intestine.
* History of exocrine pancreatic insufficiency.
* Chronic diarrhea (excess of 2 to 3 stools/day above normal frequency).
* Active bacterial or viral infection requiring concurrent treatment.
* History of hepatitis B or C or human immunodeficiency virus.
* History of central nervous system metastasis.
* Any thrombotic event occurred \<3 months prior to Day 1.
* Conditions that may predispose subjects to seizures: History of seizure, previous significant head trauma
* Drug or alcohol abuse.
XP-Endo Finisher on Postoperative Pain in Retreatment Cases Using Mtwo R Files

Introduction: Postoperative pain is one of the most critical issues in our daily practice. , postoperative pain control is essential for patient satisfaction and comfort. When primary root canal treatment fails, root canal retreatment aims to heal apical periodontitis.

Aim of study: To compare between postoperative pain (POS) after endodontic retreatment using NI-TI rotary files Mtwo R alone and in conjunction with XP endo finisher .

Materials and Methods: This research is a randomized clinical trial conducted in a parallel design on 50 patients needing retreatment. They will be divided into two groups, group 1 retreatment with Mtwo R, group 2 retreatment with Mtwo R followed by Xp - Endo finisher. Postoperative pain levels will be evaluated at 24 hours, 48 hours, 72 hours, and 7 days following the removal of the obturation mat erial. The assessment of pain will be done through clinical examination, The Defense and veterans pain rating scale (DVPRS) and by the intake of pain killer


Eligibility Criteria:
Inclusion Criteria:

* Teeth with mature apices.
* Patients with no systemic diseases.
* No analgesic, anti-inflammatory, or antibiotic intake during 7 days before treatment.
* Teeth showing failure of initial root canal treatment and radiograph evidence of periapical bone destruction

Exclusion Criteria:

* Multi rooted teeth.
* Teeth with open apices.
* Teeth with cracks, calcification, root caries, fractures, external or internal resorption.
* Allergies to local anesthetic agents.
* Presence of severe pain and/or acute apical abscesses
Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Single and Repeated Doses of SAR441344 in Healthy Adult Subjects

Primary Objective is the tolerability and safety of ascending single and repeated intravenous infusion (IV) and/or subcutaneous (SC) administration of SAR441344

The study duration of Part 1 is approximately 22 weeks, including a treatment period of 1 day; The study duration of Part 2 is approximately 26 weeks for each subject, including a treatment period of 29 days.

Eligibility Criteria:
Inclusion criteria

- Having given written informed consent prior to undertaking any study-related procedure.

Exclusion criteria

- Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Reinforcement Learning for Warfarin Dosing

This is a clinical study designed to test the hypothesis that a computer model for dosing warfarin is superior to current clinical practice. Subjects will be randomized to two groups based on how warfarin dose is determined and followed for 6 months. The primary outcome is the percent of the time that the INR is maintained in the effective range.

This will be a single-center, open-label, randomized prospective study. Primary outcome will be percent of time within a specific INR range. Subjects will be randomized to to control and treatment groups and stratified 1:1 based on sex. The control group will have warfarin doses adjusted by experts in the treatment of patients with warfarin. The treatment group will have warfarin doses determined using a clinical support tool based on reinforcement learning. Based on simulations of the experimental design with an expectation that the percent of INR values within the target range increase by 20%, 70 subjects per group are required for statistical significance. Based on an attrition rate of 15%, the investigators will enroll 80 subjects per group. Statistical analysis will compare the percent of patients within the target INR range between groups as the primary outcome with number of adverse events between groups as the safetly outcome.

Eligibility Criteria:
Inclusion Criteria:

* Receiving anticoagulation treatment with warfarin.

Exclusion Criteria:

* Pregnancy.

  * History of hemorrhagic cerebrovascular incident.
  * Acquired or inherited hemophilia.
  * Thrombocytopenia (\<100,000 platelets per mm3) on 2 occasions separated by 2 days.
  * Anemia with hemoglobin concentration \< 10 g/dL.
  * Active cancer excluding non-melanoma skin cancers.
  * Active liver disease as documented by prolonged baseline INR ≥ 1.6.
  * Uncontrolled hypertension with 2 readings \>180/110.
  * Recent (\< 2 weeks) neurosurgical procedure.
  * Enrollment in hospice program for any diagnosis.
Increasing Physical Activity Through Personalised Motivational Messaging to Improve Cognitive Function in Lung Cancer Survivors

Objectives: To examine the effectiveness of a personalised motivational messaging intervention for improving cognitive function in lung cancer survivors.

Hypothesis to be tested: Lung cancer survivors receiving personalised motivational messaging will have better cognitive function than usual care.

Design and subjects: A randomised controlled trial in 196 lung cancer survivors with cancer-related cognitive impairment.

Intervention: The intervention group will be equipped with a wearable activity tracker for 3 months and receive personalised motivational messages via instant messaging applications (e.g., WhatsApp) to promote physical exercise. The intervention will include 1) regular messages sent at preferred times and frequencies allowing participants to choose suggested physical activity goals, and 2) support via chat-type messaging such as goal setting, real-time counselling, and practical advice. The control group will receive a leaflet on cognitive impairment with reminder text messages for follow-up surveys.

Main outcome measures: Data will be conducted at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up). Primary outcome will be cognitive function measured by HK-MoCA (objective) and Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) scale (subjective). Secondary outcomes are physical activity (IPAQ-SF), self-efficacy for exercise (SEE), psychological well-being (PHQ-4), and quality of life (EORTC QLQ-C30).

Data analysis: Intention-to-treat, post-trial qualitative (compliance with the intervention), and cost-effectiveness analyses will be conducted. We will follow the CONSORT-EHEALTH checklist.

Expected results: This trial will provide evidence on the effectiveness of the proposed intervention on improving cognitive function and increasing physical activity among lung cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

1. aged ≥ 18 years;
2. diagnosed with stage I-III non-metastatic NSCLC cancer;
3. completed primary treatment with curative intent (surgery, chemotherapy and/or radiation therapy) 6 months to 5 years prior to the baseline assessment with no recurrence or occurrence of additional cancers;
4. identified as having mild cognitive impairment by the HK-MoCA 5-Min Protocol (≤ 7th age- and education-corrected percentile cut-off score);
5. not engaged in regular exercise (defined as \< 150 min of moderate-intensity exercise per week).

Exclusion Criteria:

1. inadequate reading and verbal Cantonese comprehension for the study activities;
2. diagnosed with dementia;
3. unable to use mobile phone text messaging applications (e.g., WhatsApp).
UV Sensor in Patients With Actinic Keratosis

To validate the use of Ultraviolet (UV) radiation sensor in patients with actinic keratosis, to identify barriers to its use in prospective longitudinal studies.

To prevent both acute and chronic damage from exposure to UV A and UV B radiation. Personal UV exposure can be assessed by portable sensors. Having an accurate awareness of one's own behavior (assessed by the accuracy of the UV sensor), can motivate and engage with skin protection.

Eligibility Criteria:
Inclusion Criteria:

\>=65 years presenting actinic keratosis on scalp and/or face

Exclusion Criteria:

Patients who, due to health problems or lifestyle habits, do not expose themselves regularly to UV radiation (outdoor) for at least one hour a day.
Population-based Estimates of Medical Comorbidities in Women With Lower Urinary Tract Symptoms or Pelvic Organ Prolapse

The purpose of this study is to investigate the comorbidities of lower urinary tract symptoms or pelvic organ prolapse in a nationwide population-based data in Taiwan during the study period of 2001-2010, a total of 10 years.


Eligibility Criteria:
Inclusion Criteria:

* all cases with lower urinary tract symptoms
Fluid Responsiveness Tests in Critically Ill Patients During Admission to the Intensive Care Unit

The goal of this observational study is to investigate the prevalence of conditions allowing the performance fluid responsiveness tests in critically ill patients during admission to the intensive care unit.

Patients admitted to the intensive care unit are very often hemodynamically unstable. In these cases fluid responsiveness tests should be performed to assess whether the patient would benefit from the fluid administration.

However, fluid responsiveness tests have many limitations including lack of spontaneous breathing, necessity of invasive mechanical ventilation with tidal volume of \> 8 mL/kg ideal body weight, regular hearth rhythm, and lack of abdominal hypertension.

In the study, the investigators evaluated the prevalence of conditions enabling the performance fluid responsiveness tests in patients admitted to the intensive care unit. An assessment was performed within the six hours after admission to the intensive care unit. Evaluation was based on transthoracic echocardiography, clinical examination of the patients, and data derived from anamnesis.

The following fluid responsiveness tests were included into assessment: passive leg raising test, end-expiratory occlusion test, pulse pressure variation, stroke volume variation, velocity time integral variation in left ventricle output track, tidal volume challenge, inferior vena cava diameter variation, and superior vena cava diameter variation.

The aim of the study was to assess how many patients have the conditions allowing performance fluid responsiveness tests during admission to the intensive care unit.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients admitted to the intensive care unit

Exclusion Criteria:

1. Age under 18
2. The researcher unavailable in the intensive care unit
3. Patient assessment cannot be completed within the first six hours after admission to the ICU