cyrilzakka/clinical-trials huggingface dataset:
The Effect of Carotid IMT (Intima Media Thickness) on Postoperative Cognitive Dysfunction in Patients Undergoing Off-Pump Coronary Artery Bypass Graft Surgery

The patients who have undergone cardiac surgery have higher likelihood of postoperative cognitive dysfunction (POCD). The carotid intima-media thickness (IMT) is associated with cognitive dysfunction in the old. The aim of this study is to evaluate the effect of carotid IMT in patients undergoing OPCAB(off-pump coronary artery bypass surgery) on postoperative cognitive dysfunction. Two hundred twenty four patients, aged 20 to 79 years, scheduled for OPCAB will be divided into increased IMT (n=112) and normal IMT (n=112) group by preoperative B-mode ultrasonography. The cognitive function measured by K-MMSE, MOCA-K before the operation, and on the 7 day, 3 months after operation. The patients in the non-surgical group are measured three times: baseline, after 7days, after 3 months.


Eligibility Criteria:
Inclusion Criteria:

- patients who are scheduled to undergo OPCAB

Exclusion Criteria:

* severe cognitive dysfunction
* disabling mental change disorder
* unable to communicate or speak Korean
* do not have carotid IMT measurement.
Gemcitabine in Treating Patients With Advanced Colorectal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who have advanced colorectal cancer.

OBJECTIVES:

* Determine the response rate in patients with advanced colorectal cancer treated with gemcitabine.
* Determine the toxic effects of this drug in these patients.
* Determine the progression-free survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV continuously over 24 hours on days 1, 8, and 15. Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 12-41 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed advanced colorectal cancer that has failed at least 1

prior course of fluoropyrimidine-based chemotherapy

Measurable and/or evaluable disease

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* 0-2

Life expectancy:

* At least 3 months

Hematopoietic:

* WBC at least 3,000/mm3
* Platelet count at least 100,000/mm3

Hepatic:

* Bilirubin no greater than 2.5 times upper limit of normal (ULN)
* ALT and/or AST no greater than 3 times ULN (no greater than 10 times ULN if
* secondary to hepatic involvement by tumor

Renal:

* Creatinine no greater than 2.0 mg/dL

Cardiovascular:

* No history of cardiac arrhythmias requiring chronic treatment beyond an
* acute event (e.g., arrhythmias during severe electrolyte abnormalities
* allowed)
* No active cardiac disease requiring treatment other than hypertension,
* stable angina, or chronic valvular disease

Other:

* No other malignancy within the past 5 years except curatively treated
* (including surgically cured) cancer
* No serious medical or psychiatric illness that would preclude study
* No active uncontrolled bacterial, fungal, or viral infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics
* No more than 3 prior chemotherapy regimens
* Must have 1 prior fluorouracil-based regimen and 1 other cytotoxic agent
* (e.g., irinotecan)
* More than 4 weeks since prior chemotherapy
* Prior gemcitabine allowed
* No other concurrent antineoplastic therapy

Endocrine therapy:

* Not specified

Radiotherapy:

* More than 4 weeks since prior radiotherapy

Surgery:

* More than 4 weeks since prior surgery
Characterisation of Fractionated Electrograms Critical for Maintenance of Atrial Fibrillation (AF)

The purpose of this study is to characterise which fractionated electrogram morphologies are important to target in the catheter ablation of atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* patients with persistent AF listed for first time catheter ablation

Exclusion Criteria:

* age \< 18 years
* pregnancy
* contraindications to procedure
* recent myocardial infarction, coronary intervention, or cardiac surgery
Soft Tissue Healing After Tooth Extraction

Statement of the problem: Tooth extraction results in hard and soft tissue loss which complicates prosthodontic rehabilitation, So different techniques of alveolar ridge preservation should be done to maintain hard and soft tissue dimensions.

Aim: The aim of this study is to compare the effect of amnion membrane versus chorion membrane on soft tissue healing among socket preservation procedure.

Aim: The aim of this study is to compare the effect of amnion membrane versus chorion membrane on soft tissue healing among socket preservation procedure.

Materials and Methods: This parallel arm, randomized controlled clinical trial will involve systemically free patients with remaining roots or badly decayed teeth in the posterior region not indicated for immediate implant placement. They will be randomly allocated to two equal groups. Group A (n=95) socket will be grafted with HAM particulate and the socket will be covered with amnion membrane, and group B (n=95) socket will be grafted with HAM particulate and the socket will be covered with chorion membrane. Soft tissue healing will be assessed (1ry outcome) every day for the first week, day after day second week, once in third and fourth week. Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post surgically. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed to assess the parameters and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who need simple extraction not indicated for immediate implant placement.

Exclusion Criteria:

1. Patients with inability or anticipated failure to maintain adequate oral hygiene.
2. Pregnant or breast-feeding mothers.
3. Any medical condition or therapy that can affect healing.
A Multiple Dose Study Of Ertugliflozin (PF-04971729, MK-8835) In Otherwise Healthy Overweight And Obese Volunteers (MK-8835-037)

Ertugliflozin (PF-04971729, MK-8835) is under development for the treatment of Type 2 Diabetes. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, of multiple oral doses of ertugliflozin.

To evaluate the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics, of multiple oral doses of ertugliflozin.

Eligibility Criteria:
Inclusion Criteria:

Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.

Body Mass Index (BMI) of 26.5 to 35.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Evidence of glycosuria, as defined by a positive urine dipstick test; Fasting (at least 10 hours) serum triglyceride \>300 mg/dL; Fasting (at least 10 hours) LDL-cholesterol \>190 mg/dL; Fasting (at least 10 hours) serum 25-OH Vitamin D concentration \<20 ng/mL
A Study of MabThera/Rituxan (Rituximab) in Combination With Fludarabine And Cyclophosphamide as Primary Therapy in Elderly Patients With Chronic Lymphocytic Leukemia

This single arm, open-label study will assess the safety and efficacy of low dose fludarabine and cyclophosphamide in combination with standard dose MabThera/Rituxan (rituximab) as primary therapy in elderly patients (\>/= 65 years) with chronic lymphocytic leukemia. Patients will receive six 28-day cycles of treatment with Mabthera/Rituxan (375 mg/m2 intravenously \[iv\] Day 0 of cycle 1, 500 mg/m2 iv Day 1 of cycles 2-6), fludarabine (12.5 mg/m2/d iv Days 1-3, cycles 1-6) and cyclophosphamide (150 mg/m2/d iv Days 1-3, cycles 1-6). Anticipated time on study treatment is 6 months, with a 30-month follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 65 years of age
* Previously untreated B-cell chronic lymphocytic leukemia (CLL)
* Binet stage C or active Binet stage A and B disease

Exclusion Criteria:

* Prior treatment for CLL
* CLL with transformation (Richter's syndrome)
* Suspected or known central nervous system (CNS) involvement of CLL
* Impaired renal or hepatic function
* Human Immunodeficiency Virus (HIV) positivity, active hepatitis B/C or Hepatitis B Virus (HBV) surface antigen positive, or any active or uncontrolled infections
* Patients with anti-HBV core antibodies (past infection with HBV) but who are negative for Hepatitis B Virus Surface Antigen (HBVsAg) (either anti-HBS Ab positive or negative) and are positive for HBV- Deoxyribonucleic acid (DNA) by Polymerase chain reaction (PCR) analysis
* Concomitant diseases requiring chronic steroid administration
* Active second malignancy within the 2 years prior to study (except for non-melanoma skin cancer and in situ cervix or breast or prostate carcinoma)
* Eastern Cooperative Oncology Group (ECOG) performance status \>/= 3
Endometriosis Transcriptomic Cell Atlas

Endometriosis is an estrogen-dependent, chronic inflammatory gynecologic disease affecting women of reproductive age, with a therapeutic wandering of 6 to 10 years. A better understanding of the initiation phase is a major challenge to improve diagnosis and treatment. The most widely accepted hypothesis to explain the formation of endometriotic lesions is the tubal retrograde reflux during menstruation. However, only 10% of the reproductive age women will develop endometriosis while 90% of women experience retrograde menstruation. This raises the question of the stem cells present in the endometrium and menstrual reflux of these patients, but also of both the peritoneal microenvironment and the estrogenic local signaling which allow the implantation of these lesions.

Using tissues collected at different phases of menstrual cycle in healthy women and patients operated for endometriotic lesions, 3 main objectives :

1. To characterize cellular heterogeneity between eutopic endometrium and ectopic lesions in parallel with peritoneal fluid to identify potential stem cells and the immune microenvironment in order to find new biomarkers (using a combination of unbiased transcriptomic, spectral flow cytometry and multiplex imaging analysis)
2. To develop organoid models that integrate peritoneal fluid elements (supernatant and/or cells) to clarify stem cell properties/characteristics and their supportive environment
3. To leverage the use of these endometrial derived-organoids to functionally study the differential influence of estrogen signaling in women with or without endometriosis

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 and under 45 years of age
* Patients with multiple endometriosis sites (superficial, deep and endometriomas) with an indication for surgery to treat disabling painful symptoms and stage III or IV endometriosis in the context of infertility.
* Healthy patients including those operated on between the ages of 18 and 45 for tubal ligation
* Healthy patients operated on between the ages of 18 and 45 for hysterectomies for benign causes other than endometriosis or adenomyosis
* Patients operated on strictly at the time of menstruation
* Participants who have not been on hormonal treatment for 2 months
* Participant having signed the free and informed consent form
* Membership of a Social Security scheme or equivalent

Exclusion Criteria:

* Patients with endometriosis non-surgically treated
* Patients with endometriosis receiving hormonal treatment at the time of surgery or having received hormonal treatment in the 2 months prior to surgery
* Patients with adenomyosis only
* Healthy non-endometriotic patients undergoing hysterectomy for infectious or malignant causes
* Patients benefiting from a legal protection measure (guardianship, curatorship, safeguard of justice)
* Patients with positive serology for human immunodeficiency virus (HIV), human T-lymphotropic virus (HTLV), hepatitis B (HBV) and hepatitis C (HCV)
Risk Factors for Colonization or Infection With Carbapenem-Resistant Enterobacteriaceae in Children

Carbapenem-resistant Enterobacteriaceae (CRE) are increasingly identified in children in China. Pediatric intensive care unit (PICU) is the high-risk area. However, data on the epidemiology of CRE in hospitalized children in PICU are limited. The objectives of this study are to characterize the risk factors for colonization or infection with CRE and describe the microbiologic characteristics of pediatric CRE isolates. The investigators will perform a single retrospective study from January 2018 to December 2019 at PICU of Children's Hospital of Fudan University .

The investigators intend to enroll all children who were hospitalized in pediatric intensive care unit PICU of Children's Hospital of Fudan University from January 2018 to December 2019. Children who had positive cultures for any Enterobacteriaceae species before their admission will be excluded. Children with a PICU length of day less than 48h will also be excluded. According to their clinical cultures results, they will be divided into non-CRE、CRE colonization and CRE infection. CRE was defined according to the 2015 Centers for Disease Control and Prevention (CDC) definition as an isolate resistant to imipenem, meropenem, or ertapenem. Clinical and demographic data will be collected from the electronic health record.

Eligibility Criteria:
Inclusion Criteria:

* All children hospitalized in PICU of Children's Hospital of Fudan University from January 2018 to December 2019.

Exclusion Criteria:

* discharge within 48 hours
* patients had a positive culture for CRE before admission
* incomplete clinical and demographic data
Tranexamic Acid Prophylaxis for Heterotopic Ossification in Elbow Fracture-Dislocation Surgery

Heterotopic ossification (HO) following elbow fracture-dislocation is a well-recognized condition that can lead to reduced range of motion, increased pain, and the necessity for repeat surgeries.

Inflammation serves as a pivotal initiating factor in the formation of (HO) following a traumatic event. The inflammatory cascade triggered can lead to the dysregulation of tissue homeostasis, thereby promoting the aberrant formation of ectopic bone. Tranexamic acid (TXA), a Food and Drug Administration (FDA) approved synthetic antifibrinolytic agent, has garnered significant attention for its potential to mitigate the inflammatory response in the context of orthopaedic surgical procedures.

This study aims to investigate the hypothesis that reducing soft tissue hematoma during elbow fracture-dislocation surgery through the intraoperative administration of TXA, can alleviate the occurrence or severity of ectopic bone formation.

Methods: A prospective randomized study was conducted on patients with elbow fracture-dislocation who underwent surgery between 2016 and 2022. A total of 50 patients were enrolled and randomly assigned to two groups. The first group received 1 gram of intravenous tranexamic acid before the operation, followed by an additional 1 gram intravenously during wound closure. The second group did not receive any anti-bleeding medication. Patients were followed up at intervals of 2 weeks, 6 weeks, 3 months, and as needed after the surgery. At the end of the follow-up period, there were 23 patients in the first group and 24 in the second group, with a median follow-up duration of 12.7 months. All patients did not receive any other form of HO prophylaxis. Postoperative radiographs and clinical outcomes were assessed and recorded.


Eligibility Criteria:
Inclusion Criteria:

1. traumatic non-pathological elbow fracture-dislocation.
2. age 18 years or older.
3. presentation within 2 weeks of injury.
4. Willingness to participate in the study

Exclusion Criteria:

1. Inability to provide consent for research participation.
2. Active infection in the operated limb.
3. Previous hip fracture.
4. Head injury.
5. History of deep vein thrombosis (DVT).
6. History of venous thromboembolism (VTE).
7. Ischemic heart event within the last six months.
8. Stroke (CVA) within the last six months.
9. Coagulopathies.
10. Pregnancy.
The Effect of Listening to the Holy Quran on Vital Signs in Coma Patients

The aim of this study is to examine the effect of the Holy Quran listened to to coma patients on their vital signs.

Does listening to the Holy Quran have a positive effect on the life values of coma patients?

This study aims to examine the effect of listening to the Holy Quran on vital signs (fever, pulse, respiration, systolic-diastolic blood pressure, saturation) in surgical intensive care unit patients. The unique value of this study, unlike other studies, is to examine the positive changes in patients' vital signs by listening to the Holy Quran (Surah Rahman) instead of classical music.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years of age
* Being a surgical intensive care patient
* Having a Glasgow coma score of 8 points or less

Exclusion Criteria:

* The patient must be under 18 years of age
* Have a Glaskow coma score above 8 points
* Be out of coma during the time the research continues
Harnessing the Effect of an Open-Label Placebo on Fatigue in Cancer Survivors

This research study is evaluating the usefulness of a placebo (a tablet with no active ingredients) on fatigue in cancer survivors.

Fatigue can be a problem for some people after cancer treatment. In clinical trials, placebos (tablets with no active ingredients) have been shown to improve symptoms of some medical conditions including fatigue. This study is being done to test the usefulness of taking placebos for improving cancer-related fatigue. In this study, the investigators are testing whether symptoms of fatigue will improve when people know they are taking a tablet with no active ingredients.

This is a randomized study, which means the participant will be put into one of two groups. Because no one knows which of the study options is best, the participant will be 'randomized' into one of the two study groups. Randomization means that the participant will be put into a group by chance. It is like flipping a coin. Neither the participant nor the research doctor will choose what group he or she will be in. The participant will have an equal chance of being placed in each of the groups.

Eligibility Criteria:
Inclusion Criteria:

* Cancer survivor, with no evidence of active disease
* ≥18 years of age
* ≥6 months and \<10 years post active treatment
* Reports being bothered by fatigue in the past month and has a score of \<43 on FACIT-F.
* Able to read and write in English

Exclusion Criteria:

* Being evaluated or likely to be evaluated for a medical cause of fatigue (e.g., anemia, hypothyroidism) during the study. (per provider report)
* Have indications of sleep apnea as assessed by Epworth Sleepiness scale score ≥10.
* Are receiving, or are likely to receive another intervention for the treatment of fatigue during the study period. (per provider report)
Evaluation of the Naturalistic User Experience of the Website "ich Bin Alles @Schule" (i Am Everything @school)

The aim of this study is to investigate the naturalistic user experience and acceptance of the German website "ich bin alles @Schule". This website for educational professionals offers information on depression and mental health of pupils. Another aim of this study is to determine whether the desired target groups of the website can be reached.

Depressive disorders are among the most common psychiatric disorders in childhood and adolescence and yet often are unnoticed and not treated for a long time. Depressive disorders often begin in adolescence and young adulthood. School stress, caused by bullying experiences at school or high performance expectations from parents and teachers, has been identified as an important factor in the development of depressive disorders in students. School, as a central area of life for children and young people, is an important place for promoting pupils' mental health. The rising prevalence of depressive disorders among adolescence in recent years and the delayed start of interventions show a clear need for action in the everyday lives of adolescents. The Department of Child and Adolescent Psychiatry of the Hospital of the LMU Munich and the Beisheim Foundation launched the innovative digital information portal "Ich bin alles @Schule" (i am everything @school; www.schule.ich-bin-alles.de) in November 2023. "ich bin alles @Schule" is a German information platform that was developed for educational professionals and aims to provide low-threshold information about depression and mental health in the school context.

Due to the high relevance of comprehensively evaluating web-based information services on mental health and mental illness, the aim of this study is to use established methods to learn more about the visitors of "ich bin alles @Schule" and their user experience.

The aim of the study is a scientific evaluation of the naturalistic user experience of "Ich bin alles @Schule" users. For this purpose, an online questionnaire and the website analysis tool "Matomo" is applied. The study is intended to provide clues as to whether the "ich bin alles @Schule" information platform is a useful and trustworthy source of information for the target group. The information obtained is of central importance for potential adaptations and optimizations of the website. Another aim of this study is to determine whether we can actually reach the desired target group with our website. The results of the data collection also provide an important basis for future approaches aimed at school professionals about mental health issues and mental illness in a way that is appropriate for the target group.

Eligibility Criteria:
Inclusion Criteria:

* 40 seconds Website-use

Exclusion Criteria:

-
Study of LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome

The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX1031 versus a placebo control in subjects with non-constipating irritable bowel syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18-70 years old
* Documented diagnosis of IBS (IBS-diarrhea or IBS-mixed) based upon Rome III criteria
* Abdominal pain/discomfort at least 2 days per week during the screening and run-in periods
* Normal structural evaluation of the colon within 5 years prior to screening
* Ability to provide written informed consent

Exclusion Criteria:

* Inability to discontinue current drug therapy for IBS, except for bulking agents, through the duration of the study
* Use of anticholinergic antidepressants, opioid pain medications, or any drugs that affect bowel motility
* Lactose intolerance
* Major psychological disorder
* Significant nicotine or caffeine use (\>10 cigarettes and/or six 8 ounce cups of coffee per day, respectively)