cyrilzakka/clinical-trials huggingface dataset:
Bioelectrical Impedance Analysis as a Bedside Tool to Estimate Volume of Distribution of Hydrophilic Antimicrobials in Critically Ill Patients

Bioelectrical impedance analysis is studied as a bedside tool to estimate capillary leak in order to guide dosing of hydrophilic antimicrobials.

Abstract Background: Recent data suggest that antimicrobial pharmacokinetics (PK) like volume of distribution (Vd) or drug clearance (CL) is extremely altered in critically ill patients with sepsis or septic shock due to pathophysiological alterations (e.g. influence on fluid status). Bioelectrical impedance analysis (BIA) was recently introduced as a simple, non-invasive, bedside technique to assess hydration status. The primary aim of the present study was to explore the correlation between BIA parameters and Vd of hydrophilic antimicrobial agents in critically ill patients. Furthermore, the relationship between BIA measurements and clinical observations was evaluated.

Methods: We performed a validation study in healthy volunteers in September 2015 that confirmed the reproducibility of BIA. Subsequently, a prospective observational study was carried out in eligible patients treat-ed with amoxicillin/clavulanic acid, meropenem, piperacillin/tazobactam or vancomycin, admitted at the in-tensive care unit (ICU) of the University Hospitals Leuven from October 2015 to March 2016. BIA measurement was performed on the same day as the collection of blood samples to calculate PK parameters of the administered antibiotic.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to ICU ward
* Treated with one of the four studied antimicrobials

Exclusion Criteria:

* \<18 years
* Pregnant
* Do Not Resuscitate code 2 or 3
* Renal replacement therapy
* ECMO
* Pacemaker/defibrillator
* Extended burns or dermatological ilness
Effect of Enalapril and Losartan Association Therapy on Proteinuria and Inflammatory Biomarkers in Diabetic Nephropathy: a Clinical Trial on Type 2 Diabetes Mellitus

Chronic kidney disease (CKD)has become a significant health problem worldwide. Strategies to decrease the rate of progression of this disease and reduce the number of patients needing dialysis or renal transplantation are urgently needed. In this study we wish to compare the effect of dual blockade of renin-angiotensin system (ACE inhibitors plus angiotensin II receptor blocker) compared to the effect of ACE inhibitor monotherapy in patients with diabetic chronic nephropathy.

Diabetic kidney disease is the current leading cause of chronic kidney disease (CKD) in the world. Despite all efforts to control this disease, rates of CKD progression are still high and a significant number of patients will ultimately need renal replacement therapy. Pharmacological blockade of renin-angiotensin system is one of the key elements of CKD secondary prevention, and ACE inhibitors or angiotensin II receptor 1 blocker (ARB)can be used for this purpose. However, it is still not clear if dual blockade (ACEi and ARBs simultaneously)is superior to monotherapy with ACE inhibitors or ARBs. A recent trial has suggested that dual blockade is superior to monotherapy in non-diabetic chronic kidney disease. The purpose of this trial is to evaluate the effect of combination therapy compared to ACE inhibitors alone in type 2 diabetic patients with macroalbuminuric diabetic nephropathy.

Eligibility Criteria:
Inclusion Criteria:

* diabetic nephropathy characterised by a daily proteinuria superior to 500 mg
* type II diabetes

Exclusion Criteria:

* type 1 diabetes
* serum creatinine \> 2.5 mg/dL or creatinine clearance lower than 30 ml/min
* serum potassium \> 5.5 mEq/L
* intolerance or allergy to ACE inhibitors or BRA
* pregnancy
* hepatitis C or B
* HIV
* current chemotherapy treatment
Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.

The purpose of this study is determine if the triplet combination of ribociclib, everolimus and exemastane is safe and effective in the treatment of locally advanced/metastatic breast cancer following treatment with a CDK 4/6 inhibitor

This trial had two phases. The purpose of Phase I dose escalation and dose de-escalation was to determine the maximum tolerated doses (MTDs) and/or identify the recommended Phase II dose (RP2D) of the combination treatment of ribociclib+ everolimus + exemestane. The dosing was continuous in adult men and postmenopausal women with HR+ HER2-negative advanced breast cancer which was resistant to the non-steroidal aromatase inhibitors, fulvestrant or tamoxifen.

The purpose of the phase II portion of this trial was to evaluate the anti-tumor activity of exemestane, everolimus and ribociclib combination therapy following progression on a CDK 4/6 inhibitor.

The planned duration of the study was 30 months.

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women
* Patient has a confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory and has HER2-negative breast cancer
* Patient must have either measurable disease by RECIST 1.1 or bone lesions in absence of measurable disease.
* ECOG Performance Status 0 - 1
* Disease refractory to either, AI, tamoxifen or fulvestrant
* Previously treated on any CDK 4/6 inhibitor.
* Patient has adequate bone marrow and organ function.

Exclusion Criteria:

* Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment.
* Patient has received more than one line of chemotherapy for advanced disease.
* Previous treatment with mTOR inhibitors, or exemestane for advanced disease.
* Progressed on more than one CDK 4/6 inhibitor
* Patient with CNS involvement unless they are at least 4 weeks from prior therapy completion.
* Clinically significant, uncontrolled heart disease and/or recent cardiac events.
HPI in Laparoscopic Colorectal Surgery

Using the Hypotension Prediction Index in patients undergoing laparoscopic colorectal surgery, including data from National Taiwan University Hospital and Taipei Veterans General Hospital

Intraoperative hypotension is a common occurrence during laparoscopic colorectal cancer resection, often attributable to factors such as general anesthesia, the growing population of elderly patients, and the use of pneumoperitoneum during surgery. This condition, defined as a mean arterial pressure (MAP) below 65 mmHg, is linked to major organ complications within 30 days postoperatively. Introduced in 2019, the Hypotension Prediction Index (HPI) is an algorithm designed to predict the onset of intraoperative hypotension. Previous studies have used the time-weighted average MAP below 65 mmHg as a primary endpoint, calculated as the area under the MAP curve \<65 mmHg (mmHg × hours) divided by the duration of surgery (hours), with a value ≥0 indicating severity. Higher values reflect more severe hypotension. However, research on the application of HPI in laparoscopic colorectal cancer resection remains limited. This study aims to determine whether the use of HPI can reduce the severity of intraoperative hypotension in patients undergoing laparoscopic colorectal cancer resection and whether it can decrease the incidence of major postoperative organ complications. A total of 120 patients, aged 20-80 years and undergoing elective laparoscopic colorectal cancer resection, will be randomly assigned to two groups: an intervention group guided by HPI and a control group without HPI guidance. In the intervention group, an alert will be triggered when the HPI exceeds 85, indicating a potential MAP drop below 65 mmHg, whereas the control group will initiate hypotension treatment only when MAP falls below 65 mmHg. Both groups will adhere to the same intraoperative hypotension management protocols, including fluid resuscitation, vasopressor administration, and observation. The primary treatment outcome will be the time-weighted average MAP \<65 mmHg, and major postoperative organ complications will be monitored for 30 days post-surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective laparoscopic colorectal surgery

Exclusion Criteria:

* Severe heart or lung diseases
To Assess the Effects of Single Dose of JMKX001899 on QTc Interval in Healthy Subjects

Study to assess the effect of JMKX001899 on QTc interval in healthy volunteers

A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study to Evaluate the Pharmacokinetics and the Effect on Cardiac Repolarization of JMKX001899 Administered as a Tablet Formulation Under Fed Conditions in Healthy Subjects

Eligibility Criteria:
Inclusion Criteria:

1. Healthy, adult, male or female 18-45 years of age, inclusive.
2. Body mass index (BMI) between 19 and 28 kg/m2 (inclusive) and weight at least 50 kg.
3. Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.

Exclusion Criteria:

1. Patients with a history of clinically significant diseases including, but not limited to, gastrointestinal, renal, liver, neurological, hematological, endocrine, neoplastic, pulmonary, immune, psychiatric, or cardiovascular and cerebrovascular diseases, epilepsy, bipolar disorder/mania, intraocular hypertension, or acute angle-closure glaucoma.
2. Female subjects with a positive pregnancy test or lactating.
3. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) or Treponema pallidum（TP-Ab）
Comparison of Responsiveness of Different Pain and Disability Measurements in Plantar Fasciitis

The aim of the present study is compare the frequently used pain and disability assessment questionnaires before and after 5 sessions of standard treatment for patients admitted to the Physical Medicine and Rehabilitation outpatient clinic for plantar fasciitis and who were queued to receive extracorporeal shock wave therapy (ESWT) treatment.

The study was designed as prospective observational research. Between December 2019 and May 2020, 90 patients who were admitted to the Physical Therapy and Rehabilitation outpatient clinic for ESWT were planned to be included in the study. Pre-treatment pain values of patients with 3 different examination methods (visual analog scale, numerical pain scale and heel sensitivity index), 3 different disability index Foot function index, Foot and Ankle Outcome Score, The American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score will be used.

These methods will be evaluated before and after ESWT treatment and the responsiveness and minimal clinically important difference of the questionnaires will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years and older
* Patients with chronic heel complaints for more than 1 month
* Patients queued for ESWT

Exclusion Criteria:

* Patients under the age of 18
* Patients who do not want to participate in the study voluntarily
* Patient undergone physical therapy for the same heel in the last 6 months
* Patients treated for heel pain
* Rheumatologic diseases that cause heel pain (ankylosing spondylitis, Behçet's disease)
* Neurological diseases (such as diabetic polyneuropathy, postpolio syndrome)
* Patients with malignancy
* Illiterate patients with speech pathology
Phase 2 Study of Indomethacin Capsules to Treat Dental Pain

The purpose of this study is to determine whether Indomethacin Test Formulation Capsules are safe and effective for the treatment of dental pain.


Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female between 18 and 50 years of age
* For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
* Patient requires extraction of 2 or more third molars
* Patient must be willing to stay at the study site for at least 8 hours after dosing of the study drug

Exclusion Criteria:

* Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
* Patient has a current disease or history of a disease that will impact the study or the patient's well-being
* Patient has used or intends to use any of the medications that are prohibited by the protocol
* Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
* Patient has taken another investigational drug within 30 days prior to Screening
HISTOLOGICAL RESULTS IN TRANSGENDER INDIVIDUALS ASSIGNED TO FEMALES AT BIRTH UNDERGOING GENDER AFFIRMATION SURGERY AND IN TESTOSTERONE THERAPY

The aim of this study is to report histological results of genital organs removed during gender affirmg surgery in transgender people assigned female at birth (AFAB), to increase the knowledge about the long-term effects of gender affirming hormone therapy with testosterone on these organs and to evaluate the incidence of benign and malign gynecological pathology in AFAB transgender people.

This retrospective, observational, single-center study aims to analyze histological data obtained from the analysis of ovaries, fallopian tubes, uterine body, endometrium, and cervix of assigned female at birth (AFAB) transgender individuals who underwent gender affirming surgey (GAS) with hysterectomy and bilateral adnexectomy or hysterectomy alone following the administration of exogenous Testosterone (T). Histological results of the genital organs removed during GAS can provide important information about the effects and safety of loong term T treatment on these organs. Data on this subject is scarce in the literature. For this reason, even today, pathologists have not been able to establish guidelines for describing the histological results obtained from these patients.Furthermore, this analysis will evaluate the incidence of benign and malignant gynecological pathology in AFAB transgender people.

Eligibility Criteria:
Inclusion Criteria:

* gender incongruence diagnosis
* people assigned female at birth
* age \>18 years
* gender affirming surgery with hysterectomy
* testosterone therapy

Exclusion Criteria:

* previous gynecological surgery
* previous gynecological disorder diagnosis
Holmium Laser Uretherotomy in Combination With Intralesional Steroids in Bulbar Uretheral Stricture

the purpose is to evaluate the outcome of visual internal uretherotomy with Holmium laser along with intralesional steroid injection.

In this study, the investigator evaluates the efficacy of Holmium laser in combination with intra lesional steroid injection in the treatment of bulbar urethral strictures

Eligibility Criteria:
Inclusion Criteria:

1. Presence of obstructive symptoms,
2. Short segment strictures (stricture length \<2 cm) as evident on radiological studies, i.e. retrograde urethrography and micturating cystourethrography.
3. Peak flow rate on uroflowmetry less than 15 ml/s

Exclusion Criteria:

1. Complete obliteration of lumen of urethra on urethroscopy,
2. Balanitis Xerotica Obliterans,
3. Age less than 18 years,
4. Multiple strictures,
5. Active urinary tract infection,
6. Recurrent Strictures.
7. Prior internal uretherotomy
8. Prior urethroplasty
9. Pan-anterior urethral strictures
10. Posterior stenosis
11. Those who lost to follow up
Acute Pain Management Following Video-assisted Thoracoscopic Surgery: Comparison of Lobectomy and Wedge Resection

Viedo-assisted thoracoscopic surgery(VATS) have became popular in recent years. There is no golden rule of postoperative analgesia for VATS. Compared with lobectomy, wedge resection preserves better pulmonary function and is suitable for elder patients and patients who could not afford to have lobectomy. In addition to surgery time、recovery time and hospital stay, wound incisions and organization damages are different,too. Will patients also have different response to pain control after these two surgery? The retrospective study is to compared the differences of postoperative pain management between VATS lobectomy and wedge resection.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 20
2. Using intravenous patient-controlled analgesia for postoperative analgesia
3. ASA physical status classification I-III

Exclusion Criteria:

1. Staying in intensive care unit after surgery
2. Emergency surgery
3. Pregnancy
4. Other surgery incisions which are not used for the video-assisted thoracoscopic surgery
5. Patients never use intravenous patient-controlled analgesia after surgery
Lacritin and Heparanase Levels in Human Tears After Laser Refractive Surgery

The purpose of this study is to measure tear lacritin and heparanase levels before and following surgery using a minimal risk procedure to collect tears from patients undergoing PRK or LASIK.

Lacritin is a naturally occurring tear protein with antimicrobial activity that is capable of stimulating mitogenesis in human corneal epithelial cells and promoting production of tears in lacrimal gland acinar cells. A recently developed immunoassay for lacritin may help characterize the lacritin response following refractive surgery with the possible development of recombinant lacritin as a novel therapeutic agent for wound healing. Heparanase (HPSE) acts as a regulator for lacritin by cleaving heparan sulfate chains and allowing lacritin to bind. We aim to measure both tear lacritin and HPSE pre- and post-operatively to elucidate lacritin and HPSE's response in patients undergoing PRK (photorefractive keratectomy) and LASIK (Laser-assisted in situ keratomileusis) at the Walter Reed Center for Refractive Surgery.

Eligibility Criteria:
Inclusion Criteria:

* Active duty US Army Soldiers eligible for care at FBCH
* Undergoing PRK or LASIK
* Male or female, of any race, and at least 21 years old and not older than 55 years old at the time of the tear collection. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
* Appropriately aged individuals who report that their eyes are "normal" and who have no active eye illness as determined by the principal investigator or sub-investigator.
* Ability and willingness to understand and provide informed consent to participate in this study.
* Up to -10.00 diopters of myopia.
* Subject must expect to be located in the greater Washington DC area for a 12 month period post-operatively.
* Consent of the subject's command (active duty) to participate in the study.
* Access to transportation to meet follow-up requirements.

Exclusion Criteria:

* Any reason to be excluded for PRK or LASIK
* Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. Female subjects will be given a urine pregnancy test prior to participating in the study to rule out pregnancy. \[Pregnancy and breastfeeding are contraindications to refractive surgery in general, including PRK, whether participating in this study or not\]
* Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
* Any physical or mental impairment that would preclude participation in any of the examinations.
* Anterior basement membrane dystrophy
* History of recurrent epithelial erosion
* Significant dry eye (symptomatic with Schirmer \<5mm at 5 minutes)
* Other corneal epithelial disorder or healing abnormality
* Individuals with any infectious or inflammatory ocular conditions (e.g. have "pink eye" or uveitis).
* Individuals diagnosed with dry eye or other ocular surface condition, including but not restricted to neurotropic keratitis, anterior basement membrane dystrophy, and recurrent corneal erosions.
Determination of Risk Factors for the Development of Obesity and Hypertension in Children According to Perinatal Programming of Metabolism

to determine the risk factors for developing obesity in children with exogenous-constitutional obesity and arterial hypertension, according to the theories of early programming of metabolism

A retrospective cohort study of 55 children aged 12 to 18 years (average 14.60±0.24 years) with exogenous-constitutional obesity was conducted, with 24 girls (43.6%) and 31 (56.4%) boys. Children were identified during dispensary examinations in family clinics in Samarkand in the period 2018-2019. All the examined children belonged to the Uzbek population.

Eligibility Criteria:
Inclusion Criteria:

* SDS (standart deviation score) of body mass index (BMI) ranging from +2.0 to +3.0

Exclusion Criteria:

* secondary obesity and overweight genetic syndromes,
* refusal of the child and/or parents to be examined
Performance of OrbiSymm in Subjects Referred to Contra Lateral Breast Symmetrisation

This is a Phase IV, multicenter, open label, non-randomized comparative group study to assess the safety and performance of the OrbiSymm system in subjects referred to contra lateral breast symmetrization involving a breast reduction following breast reconstruction post-mastectomy.

The device has the CE Mark and will be used in the indication for which it is approved.

Up to 60 patients will be assigned to the study (up to 30 patients for Orbix procedure, and up to 30 patients without Orbix procedure (only routine reduction/symmetrisation). Patients will return to the clinic for follow-up at 1, 3, 6, 12 \& 24 months (last visit will be optional).

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent before any study specific tests or procedures are done.
2. Female subject between the age of 20 and 65 years old
3. Underwent breast reconstruction following unilateral mastectomy and referred to contra lateral symmetrisation procedure that requires reduction of at least 150gr (clarification: the procedure of reconstruction and symmetrisation may be performed simultaneously).
4. Breast size ≥D
5. BMI≤ 32

Exclusion Criteria:

1. Pregnant or lactating woman.
2. Subject with history of surgical procedures involving the ribs and rib cage.
3. Subject with documented osteoporosis (bone density per DEXA of less than -1.8).
4. Subject with breast implants.
5. Subject is suffering from breast carcinoma or residual malignant tumor in the side of symmetrisation.
6. Subject suffering from reconstruction failure, skin necrosis or implant infection.
7. Subject with diagnosed or suspected auto-immune disease.
8. Subject with pathologies that affect blood coagulation, immune system or any treatment interfering with them.
9. Subject with lesions due to radiation, ulceration, vascular anomalies or history of circulatory disorder.
10. Subject suffering from a progressive fibrocystic disease, considered to be pre-cancerous, without mastectomy.
11. Subject with concurrent diseases determined by the surgeon to pose unduly high risk of surgical and/or postoperative complications such as obesity, smoking, diabetes, autoimmune disease, coagulopathy, chronic lung or severe cardiovascular disease.
12. Use of drugs that might result in high surgical risk and/or significant postoperative complication, including drugs that would interfere with blood clotting.
13. Psychological instability, inappropriate attitude or motivation.
14. Subject participating or that has participated until one month prior to planned procedure, in another investigational study.