cyrilzakka/clinical-trials huggingface dataset:
Loop Diuretics in Chronic Kidney Disease

The purpose of this study is to verify the efficacy of diuretic therapy on blood pressure control and left ventricular mass in patients affected by chronic kidney disease

In CKD, impairment of renal function causes fluid and sodium retention and consequently expansion of extracellular volume, which corresponds to about 5% of body weight in absence of peripheral edema. In particular, sodium retention increases exponentially as glomerular filtration rate declines and is of primary importance in the pathogenesis of hypertension. Therefore, reduction of salt intake in renal patients allows a better blood pressure control. Despite the evidence collected on the beneficial effects of salt restriction in CKD, compliance with dietary prescription is generally poor in patients followed up in the real world of clinical practice. In the presence of poor adherence to salt restriction, diuretics agents become the cornerstone of treatment of hypertension secondary to CKD. Disappointingly, nephrologists are reluctant to "adequately" use loop diuretics in their hypertensive CKD patients, probably because of the fear of side effects and of the amazing absence in medical literature of studies of middle-long term on diuretic efficacy. Therefore, the primary aim of this study is to evaluate efficacy and safety of loop diuretics on blood pressure control in patients affected by CKD.

Eligibility Criteria:
Inclusion Criteria:

* Chronic renal insufficiency in stage CKD 3 and 4 (GFR 60-15 ml/min/m2) estimated by Cockcroft-Gault formula corrected for body surface
* Systolic blood pressure \>140 mmHg in treatment with at least 1 class of antihypertensive drugs
* Patients not in treatment from at least one month with loop diuretics

Exclusion Criteria:

* Loop diuretics treatment
* Variation of serum creatinine \>30% in the last 3 months
* Steroid therapy and/or cytotoxic agents
* Edema syndromes (Nephrotic syndrome, cirrhosis, heart failure NYHA class 3 or 4)
* Neoplasia
Oral Iohexol in the Management of Chylous Ascites After After Retroperitoneal or Extended Lymphadenectomy

The goal of this clinical trial is to assess the effectiveness of oral iohexol in the treatment of postoperative chylous ascites. It will also learn about the safety of oral iohexol. The main questions it aims to answer are:

* Confirm the potential of oral iohexol as an innovative therapeutic regimen.
* Confirm its ability to improve clinical outcomes for patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 and 75 years;
* Patients underwent retroperitoneal or extended lymphadenectomy for abdominal or pelvic malignant tumors;
* Patients diagnosisted with postoperative Chylous ascites. Chylous ascites were defined by the presence of non-infectious, milky, or creamy effluent in drainage tubes surpassing 200 mL daily, paired with triglyceride concentrations exceeding 110 mg/dL

Exclusion Criteria:

* Patients with severe cardiac, hepatic and renal insufficiency;
* Patients with a history of iohexol allergy or allergy to contrast media;
* Patients who have received other interventions;
* Patients with severe intestinal obstruction or intestinal perforation;
* Patients who are unable to comply with the requirements of the study or are unable to complete follow-up.
The REMINDER4Care Program for Older Adults Supported by Residential and Daycare Facilities

Dementia incidence is rising, posing a public health challenge, but 45% of cases can be prevented by addressing modifiable risk factors. Multidomain trials show that lifestyle changes can improve cognitive function and reduce dementia risk (like the FINGER trial). The REMINDER program, a Portuguese-based dementia risk reduction protocol, was developed for community-dwelling older adults aged 55 and above. However, older adults in Residential and Daycare Facilities (RDF) have distinct needs that demand program adaptation to ensure its relevance and effectiveness. In addition, more studies are needed to evaluate the impact of multidomain interventions with older adults in RDF.

To address these challenges, the REMINDER4Care program was developed as a tailored, multidomain intervention to reduce dementia risk. It emphasizes social and cognitive engagement and advances its adaptation and evaluation in Residential and Daycare Facilities (RDF). To assess efficacy, the investigators will perform a Randomized Controlled Trial.


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years and older
* RDF users
* Elementary reading and writing skills

Exclusion Criteria:

* Have a clinical diagnosis of dementia and/or Mini-Mental State Examination (MMSE) scores below the cutoff for the presence of dementia (MMSE \< 22-27, depending on education level)
* Have a psychiatric or neurological condition that impairs cognition in the long term
* Have sensory and functional deficits that compromise their participation in the neuropsychological assessment and throughout the intervention sessions
Effectiveness of Percutaneous Neuromodulation vs Pharmacological Treatment in Cancer Patients With Anterior Knee Pain

the goal of this clinical trial is to compare in cancer patients:

Is ultrasound-guided percutaneous neuromodulation useful for Anterior Knee Pain relief in cancer patients?

Participants will receive treatments of ultrasound-guided percutaneous neuromodulation and pharmacological treatment Researchers will compare ultrasound-guided percutaneous neuromodulation versus pharmacological treatment to see if Anterior Knee Pain is reduced

Unhealthy lifestyles, an aging population and increased life expectancy increase the likelihood of cancer. Knee pain is one of the most common symptoms that cause functional incapacity, which requires the search and improvement of its assessment, prevention and treatment tools.

Physiotherapists are currently using ultrasound-guided Percutaneous Neuromodulation clinically. It is an easy process to perform, non-invasive, safe and economical.

Traditional therapies have been and will continue to be useful. The decrease in manufacturing costs of assessment tools such as ultrasound and neuromodulator treatment in recent years has made the acquisition of these equipment as intervention tools economical. This is because they have been shown to be useful for improving function and reducing pain.

Opioid analgesics are the main option for pain treatment in cancer patients, but their side effects and inadequate treatment lead to cheaper, quicker options with lower risk of addiction and/or side effects.

In order to improve these symptoms, it is essential to have an objective knowledge of the changes produced by neuromodulation and to be able to measure the variation of pain experienced by patients.

It has been demonstrated in recent years that assessment tools such as ultrasound and myotonometer are very useful, safe and non-invasive procedures, both have been consolidated as assessment tools that can evaluate changes and analyze the contractile properties of soft tissue quickly and safely. There are abundant literature on this subject.

Therefore, researchers suggest conducting research that improves and provides new data on the efficacy and effectiveness of treatment of ultrasound-guided percutaneous neuromodulation.

Eligibility Criteria:
Inclusion Criteria:

The proposed inclusion criteria for the study are as follows:

* Age between 18 and 65.
* Pain in the front of the knee.
* Taking drug therapy for lower-extremity pain.
* Diagnosis of painful pathology in the anterior aspect of the knee secondary oncologic.

Exclusion Criteria:

The exclusion criteria are:

* Traumatic history
* Have had any type of analgesic treatment in the last 4 weeks (clinical, physical or orthostatic)
* No need for drug treatment within the last 30 days of study initiation.
Menstrual Effects On Mood Symptoms in Bipolar Disorder

Background and Rationale for Study: Estrogen and progesterone are female hormones that regulate the menstrual cycle and likely serve an important role in the regulation of mood. Premenstrual Syndrome (PMS) which affects 75% of healthy women is a cyclic pattern of mild dysphoria and physical discomfort that begin 1-2weeks pre-menses, and resolve by 2-3 days post-onset of menses. Up to 66% of women with bipolar disorder (BD) describe premenstrual mood changes that range from mild symptoms to severe worsening that require hospitalization. Therefore, the hormonal shifts of the menstrual cycle likely influence bipolar symptoms, but confirmatory research is lacking.

Study questions: The primary aims and hypotheses are to characterize bipolar mood symptoms throughout the menstrual cycle and to determine if women with BD have: 1) a) increased severity and persistence of depression and mania symptoms in the late luteal (premenstrual) vs early follicular phase, b) larger change in mood symptoms from the late luteal (premenstrual) to the early follicular phase, compared to healthy women, 2) more relapses, in the late luteal compared to the early follicular phase. The secondary aims are to determine: 1) frequency and severity of premenstrual dysphoric disorder (PMDD) type symptoms in bipolar women; 2) association between bipolar mood variability and a) menstrual phase, b) ovulatory vs anovulatory cycles, c) antimanic drug treatment.

Study Design: Women with BD (15 depressed, 15 euthymic), and 15 healthy women will enter the study. Over 3-months, subjects undergo monthly visits to assess mood and function, at the follicular and luteal phases. Ovulation is confirmed with: 1) urine dipstick tests to detect ovulation (LH surge) days8-14 from the onset of menses; 2) serum progesterone levels 7-days post-ovulation (LH surge). Subjects record their mood and physical symptoms on the daily self-report LifeChart and the Daily Rating Form.

Study Population: Women with Bipolar I or II Disorder, between ages 18-45. Primary Outcomes Measures: 1) a) mood severity - scores on the Structured Interview Guide for the Hamilton Depression Scale (SIGHADS) for depression, Mania Rating Scale (MRS) for mania/hypomania, and LifeChart mood ratings depression and mania/hypomania, for the late luteal and early follicular phases; b) persistence of symptoms - proportion of days with mild/moderate/severe depression or mania/hypomania. 2) Relapses - # bipolar episodes.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-45;
* Bipolar Disorder (BD) I or II (DSM-IV criteria) must agrees to communication between PI and Psychiatrist;
* Healthy Control without Past or Current Major Depression, Psychotic Disorder, premenstrual syndrome or Premenstrual Dysphoric Disorder;
* 25-31day menstrual cycles;
* Minimum 6 menstrual cycles per year

Exclusion Criteria:

* Current DSM-IV Criteria Alcohol or Substance Abuse/Dependence;
* Pregnancy;
* Chronic Anovulation (\<4 menstrual cycles/yr);
* Menopause (\< 1menses in 1yr);
* Active thyroid disease;
* Hormonal Contraception
A Study of LY110140 in Healthy Japanese Male Participants

The purposes of this study are to look at safety, how well the study drug (LY110140) is tolerated, and how much of the study drug gets into the blood stream when given as single dose (SD) and multiple doses (MD) to healthy Japanese male participants. Participants will participate in SD portion for approximately 6 weeks and in MD portion for approximately 10 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy Japanese males (as determined by medical history and physical examination) who agree to use a reliable method of birth control during the study and for 3 months following the last dose of the investigational product.
* Have a body mass index (BMI) of 18.5 to 29.9 kilograms per square meter (kg/m\^2), inclusive, at the time of screening.
* Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the study site.

Exclusion Criteria:

* Poor metabolizers of isoenzyme cytochrome P450 2D6 (CYP2D6) (assessed at screening).
* Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study such as, a Bazett's corrected QT (QTcB) interval \>450 milliseconds (msec).
* Have any lifetime history of a suicide attempt, or have suicidal ideation or, any suicidal behavior within the last month, or who are at significant risk to commit suicide, as judged by the investigator using the Columbia Suicide Severity Rating Scale (C-SSRS).
* Are unsuitable (in the opinion of the investigator or sponsor) for inclusion in the study.
Comparison of Two Different Pleural Drainage Systems

The digital pleural drainage system Topaz+ by Medela is compared to the analogue system Atrium OCEAN by Maquet in patients undergoing cardiac surgery.

The study is prospectively randomized with an all-comer setup. The patients are randomly selected for one of the systems. The surgery is performed in the standard fashion and chest tubes are placed routinely by the surgeon depending on the type of surgery. A retrosternal 32 French drain is placed in every patient and pericardial and/or pleural drains are optional.

The postoperative course does not vary from the clinical standard and the chest tubes are removed according to institutional standard. The clinical data about fluid amount, time of removal, air leaks, tamponade are routinely collected in a digital patient documentation system.


Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing cardiac surgery
* capability to give informed consent

Exclusion Criteria:

* no specific exclusion criteria
Comparison of Colonoscopy Adenoma Detection Yield

A Prospective Randomized Comparison of colonoscopy Adenoma Detection Yield of (i) Standard Colonoscopy (SC), (ii) artificial intelligence (Discovery) aided colonoscopy, and (iii) artificial intelligence (Discovery) and permanently mounted balloon (G-EYE®) aided colonoscopy.

Multi-center, three-arm, randomized, controlled, open-label study.

Total of up to 1320 patients will be randomized, including up to 10% for subject drop-out, 440 to each of the three following arms (groups):

Group 1 (1st arm): patients will receive standard colonoscopy (SC) Group 2 (2nd arm): patients will receive colonoscopy aided by the Discovery artificial intelligence software (DC) Group 3 (3rd arm): patients will receive colonoscopy aided by the Discovery artificial intelligence software and the G-EYE® balloon (GDC) The purpose of this study is to compare between the diagnostic yield of Standard Colonoscopy, Discovery aided colonoscopy, and Discovery \& G-EYE® aided colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

1. Screening and surveillance population for Adenoma and CRC.
2. The patient must understand and sign a written informed consent for the procedure.

Exclusion Criteria:

1. Subjects with inflammatory bowel disease;
2. Subjects with a personal history of hereditary polyposis syndrome;
3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
4. Subjects with diverticulitis or toxic megacolon;
5. Subjects with prior colonic surgery (exclusion appendectomy)
6. Subjects with a history of radiation therapy to abdomen or pelvis;
7. Pregnant or lactating female subjects;
8. Subjects who are currently enrolled in another clinical investigation.
9. Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator.
10. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
11. Any patient condition deemed too risky for the study by the investigator
Written Versus Verbal Education for Mild Traumatic Brain Injury

Mild traumatic brain injury (MTBI) is a common injury that involves loss of consciousness or alteration in mental status induced by an external mechanical force to the head. Education about symptoms and reassurance of a prompt recovery usually results in full recovery. However, a subgroup appears to have persistent symptoms and disability. This study will recruit MTBI patients from two Emergency Departments with the aim of identifying modifiable patient characteristics that can delay or prevent full recovery. A secondary aim is to determine if providing education in writing or in-person makes a difference.


Eligibility Criteria:
Inclusion Criteria:

* Confirmation of a likely concussion without hospital admission
* Participants live locally with a fixed address
* Participants experience at least one new symptom

Exclusion Criteria:

* Participants who cannot understand/read English
Efficacy of Ozurdex® in the Treatment of Diabetic Macular Edema (DME)

This study will evaluate the efficacy of Ozurdex® as prescribed in clinical practice in France for the treatment of Diabetic Macular Edema (DME).


Eligibility Criteria:
Inclusion Criteria:

-Patient with Diabetic Macular Edema (DME) treated with Ozurdex® in clinical practice.

Exclusion Criteria:

-Patient not residing in metropolitan France.
Perioperative Chemotherapy With Bevacizumab for Colorectal Carcinomatosis French Part of the Main Bev-IP Study

Selected patients with peritoneal carcinomatosis (PC) from colorectal cancer (CRC) benefit from cytoreductive surgery (CRS) combined with intraperitoneal chemoperfusion (IPC). However, even after optimal cytoreduction, systemic and locoregional recurrence are common. Perioperative chemotherapy with bevacizumab (BEV) may improve the outcome of these patients. The BEV-IP study is a phase II, single-arm, open-label study aimed at patients with colorectal or appendiceal adenocarcinoma with synchronous or metachronous PC. This study evaluates whether perioperative chemotherapy including BEV in combination with CRS and oxaliplatin-based IPC results in acceptable morbidity and mortality (primary composite endpoint). Secondary endpoints are treatment completion rate, chemotherapy-related toxicity, pathological response, progression free survival, and overall survival.


Eligibility Criteria:
Inclusion Criteria:

* biopsy proven adenocarcinoma of the colon or rectum and synchronous or metachronous peritoneal carcinomatosis.
* absence of systemic disease, with the exception of small, superficial liver metastases, requiring only minor surgery.
* resectable disease at staging, during laparoscopic evaluation and during exploration for cytoreductive surgery and intraperitoneal chemotherapy.
* complete macroscopic cytoreduction at the time of surgery (CC-0/1)
* good general health status (Karnofsky index \> 70%)
* expected life expectancy more than 6 months
* no other malignancy than disease under study
* serum creatinine \< 1.5 mg/dl or a calculated GFR ≥ 60 mL/min/1.73 m2
* serum total bilirubin \< 1.5 mg/dl
* platelet count \> 100,000/ml
* hemoglobin \> 9g/dl
* neutrophil granulocytes \> 1,500/ml
* International Normalized Ration (INR) 2 or \< 2
* Absence of alcohol and/or drug abuse
* No inclusion in other clinical trials interfering with the study protocol
* No concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
* Absence of heart failure (NYHA 2 or \> 2) or significant coronary artery disease
* No pregnancy or breast feeding
* Adequate contraception in fertile patients

Exclusion Criteria:

* No written informed consent
* Tumour in the presence of obstruction
* Evidence of extra-abdominal disease or extensive liver metastasis
* Peritoneal cancer index \> 25
* Active bacterial, viral or fungal infection
* Active gastro-duodenal ulcer
* Parenchymal liver disease (any stage cirrhosis)
* Uncontrolled diabetes mellitus
* Severe obstructive or restrictive respiratory insufficiency
* Psychiatric pathology capable of affecting comprehension and judgment faculty
* Known allergy to oxaliplatin.
Peru Longitudinal Study

The purpose of this study is to evaluate the change in disease prevalence over time in impoverished urban communities in Lima, Peru.

The aim is to track the changes in disease prevalence of people living in impoverished urban communities in Lima over the next 10 years.

Based on data collected in prior years and in an ongoing manner, Ohio University Global Health teams will be introducing interventions focused to positively impact disease states and trends in this population.

The current focus is on chronic lifestyle related diseases and their precursors: cardiovascular disease, hypertension, dyslipidemia, diabetes, and overweight / obesity.

Eligibility Criteria:
Inclusion Criteria:

* minors age 12-17 presenting to the free community clinic, with a responsible adult who can give consent; minors will give assent.
* consenting adults of any age who present to the clinic.

Exclusion Criteria:

* adults who are unable to give consent.
A Phase I, Open-label, Multicenter, Dose-Escalating Study to Evaluate the Safety and Tolerability of KH658 Gene Therapy in Participants with Neovascular Age-related Macular Degeneration

VAN-2401 is Phase I clinical trial to assess the safety and tolerability of KH658 in subjects with neovascular AMD. KH658 is gene therapy designed to deliver a protein which targets and blocks VEGF via an adeno-associated viral vector. The standard of care for patients with neovascular AMD are anti-VEGF treaments, which have demonstrated improvement in vision and reduction in fluid. A one time placement of a product which inhibits VEGF has the potential to reduce the patient burden of regular ocular injections.


Eligibility Criteria:
Inclusion Criteria:

-

1. Males and Females ages 50 to 85 (inclusive) with a study eye which meets the following criteria:

a. Previously received IVT treatment of anti-VEGF for neovascular AMD, with documented response to anti-VEGF therapy during the first 2 weeks of screening b. active macular CNV lesion secondary to AMD evidenced by SD-OCT c. Have a ETDRS BCVA letter score of 63 to 25 in the study eye at Screening for the first subject in each cohort (sentinel subject), followed by ETDRS BCVA letter score of 73 to 25 for the rest of the subjects each cohort; d. Are willing and able to sign the study written informed consent form (ICF).

Exclusion Criteria:

-

1. Have had any prior ocular or systemic treatment (investigational or approved) or surgery for the treatment of neovascular AMD except IVT anti-VEGF 2. Retinal pigment epithelial tears or rips at screening 3. Any history or presence of vitreous hemorrhage; 4. Have any condition preventing visual acuity improvement; 5. Have any other cause of CNV; prior pars plana vitrectomy or scleral buckling or retinal detachment surgery; macular hole, Epiretinal membrane or vitreo-macular traction; full thickness macular hole; 6. History of intraocular or periocular surgery in the prior 3 months; 7. Prior trabeculectomy or other filtration surgery (SLT or MIGS are permitted); 8. corneal transplant; 9. Any use of long-acting intraocular steroids, including implants, within six months prior; 10. Uncontrolled glaucoma; 11. Intraocular implant 12. Participated as a subject in any interventional clinical trial within 1 month prior; 13. Have received any gene or cell therapy product at any time in the past (either eye or systemically); 14. Have active intraocular inflammation in either eye at Screening or a history of uveitis in either eye 15.Have active ocular or periocular infection in either eye; 16. Have presence or history of scleromalacia in either eye;
Communicating Evidence From Systematic Reviews to the Public

The purpose of this randomised controlled trial is to compare a new standardised summary format for presentation of synthesised evidence from systematic reviews for the public (a new plain language summary format) to the current format used in Cochrane systematic reviews. The study will evaluate if the new presentation improves understanding about the benefits and harms of an intervention, if it improves the accessibility of the information, and if it is preferred over other versions by the public over the current format.


Eligibility Criteria:
Inclusion Criteria:

* patients or members of the public 16 years or older