cyrilzakka/clinical-trials huggingface dataset:
Gut Microbiome of Patients Undergoing Antibiotic Therapy for Orthopedic Device-related Infection

The microbiome of 80 orthopedic-device related infection (ODRI) patients treated with antibiotics and 10 healthy controls will be investigated. Samples (blood, stool, saliva, skin-swab) are collected 4x within 6 months. Composition and diversity of the microbiome will be assessed by 16sRNA sequencing, skins swabs are screened for rifampicin-resistant staphylococci onto Mannitol-salt-agar plates supplemented with rifampicin, inflammation markers and antibodies in blood and saliva are monitored to track changes in the immune response. For further analysis patients are assigned to one of two groups: 1) antibiotic therapy including rifampicin and 2) non-rifampicin antibiotic therapy.


Eligibility Criteria:
Inclusion Criteria:

* The patient is planned to undergo revision surgery due to suspected bone or joint infection.
* The patient is at least 18 years old

Exclusion Criteria:

* The patient took antibiotics in the previous six weeks of recruitment (a single dose/"shot" of antibiotics during this period is not considered).
* The patient suffers from gut-associated morbidities such as Morbus Crohn or colitis ulcerosa.
* The patient suffers from psychiatric disorders/cognitive impairment affecting understanding.
* The patient is unable to give consent and follow procedures and/or has insufficient knowledge of the project language.
Study to Evaluate Safety of Brimonidine/Timolol Fixed Combination in Glaucoma or Ocular Hypertension Patients

This study evaluates the safety of brimonidine/timolol fixed combination in glaucoma or ocular hypertension patients


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ocular hypertension or glaucoma
* Patient requires IOP-lowering therapy in both eyes

Exclusion Criteria:

* Uncontrolled medical conditions
* Contraindication to β-adrenoceptor antagonist therapy or brimonidine therapy
The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments

The study will apply state of the art radiology through advanced magnetic resonance imaging (MRI) techniques to investigate structural and functional brain effects of electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS).

As a multi-disciplinary collaboration, imaging findings will be correlated to psychiatric response parameters, neuropsychological functioning as well as neurochemical and genetic biomarkers that can elucidate the underlying mechanisms. The aim is to document both treatment effects and potential harmful effects of ECT and TMS

Sample, three groups:

ECT: n = 50 patients in a major depressive episode (bipolar and major depressive disorder) who have accepted treatment with ECT.

TMS: n = 50 patients in a major depressive episode (bipolar and major depressive disorder) who have accepted treatment with TMS.

HC: = 50 age and gender matched healthy volunteers not receiving ECT nor TMS.

Observation time: six months, with the time points as specified below. ECT is typically given three times weekly, but exceptions may occur. Hence, time points are specified as the number of ECT treatments given rather than an exact number of days which will vary.

Tp1: 2 hours before the first treatment session (day 1, baseline), Tp2: 2 hours after the first treatment session (day 1), Tp3: before the 7th ECT session and corresponding time point for TMS (\~ day 15), Tp4: 1-2 weeks after last treatment session (\~ day 30 - 50), Tp5: 6 months after treatment (\~ day 180),

Healthy controls are only assessed at Tp1,2,4,5

Eligibility Criteria:
Inclusion Criteria:

ECT:

* Patients (\>18) referred to the center of ECT and accepted for treatment
* because of moderate and severe depression
* fulfilling the criteria for the following ICD-10 diagnosis: F 31.3 and F31.4; F32.1 and F32.2 and F32.3; F33.1 and F33.2 and F33.3.
* In addition, the symptom intensity must be verified by a MADRS score ≥ 25.
* There is no upper age for participation, however, the responsible clinician will consider if patients are eligible for inclusion (functioning, enabled to give informed consent).

TMS:

* Patients (\>18) referred to the center of TMS and accepted for treatment
* because of moderate and severe depression
* fulfilling the criteria for the following ICD-10 diagnosis: F 31.3 and F31.4; F32.1 and F32.2 and F32.3; F33.1 and F33.2 and F33.3.
* In addition, the symptom intensity must be verified by a MADRS score ≥ 25.
* There is no upper age for participation, however, the responsible clinician will consider if patients are eligible for inclusion (functioning, enabled to give informed consent).

Healthy controls:

* Age and gender matched (to the patient groups).
* No history of psychiatric illness and no current depression.
* No contraindication for MRI scanning.

Exclusion Criteria:

* ECT / TMS treatment within the last 12 months.
* Patients unable to give informed consent (according to the responsible clinician or ECT / TMS responsible).
* Patients who cannot participate in the MR scanning
Spirulina Supplementation and Cardiovascular Risk in Obese Caucasians With Treated Hypertension

Potential protective cardiovascular effect of Spirulina maxima supplementation was studied in a double-blind placebo-controlled trial of obese subjects with treated hypertension, each randomized to receive spirulina or a placebo.

Numerous publications have provided evidence of the effect of natural substances-supplements on improving endothelial function, and thus reducing the risk of cardiovascular diseases. Spirulina maxima (Arthrospira maxima) is a species of cyanobacterium, used as food additive because of its high levels of protein and essential nutrients, such as carotenoids, vitamins, and minerals. Various studies point to a possible beneficial effect of spirulina on the concentration of blood serum lipids and fasting glucose,body weight or blood pressure, however, the results of studies pertained to the effects of spirulina in individuals who, at the time of trial, were not taking medications. The aim of the study was to estimate an effect of Spirulina maxima supplementation on cardiovascular risk in obese Caucasians with treated hypertension. The anthropometric parameters, blood pressure, insulin sensitivity, plasma lipid levels, and stress oxidative biomarkers were measured at the baseline and after 3 months of supplementation with spirulina or placebo in the group of obese, hypertensive patients receiving standard antihypertensive treatment.

Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) equal to or greater than 30 kg/m2
* age 25 to 60 years
* stable body weight (\< 3 kg self-reported change during the previous three months)
* well-controlled hypertension (meaning systolic blood pressure (SBP) less than 160 mmHg and/or diastolic blood pressure (DBP) less than 100 mmHg) with stable treatment for at least 6 months (the patients received one drug only)

Exclusion Criteria:

* secondary obesity or secondary hypertension
* diabetes
* a history of coronary artery disease
* stroke
* congestive heart failure
* malignancy
* a history of use of any dietary supplements within the three months prior to the study
* a current need for modification of antihypertensive therapy
* abnormal liver or kidney function
* any clinically significant process
* a history of infection in the month prior to the study
* nicotine or alcohol abuse
* or other condition that, in the opinion of the investigators, would make participation not in the best interest of the patient or could prevent, limit, or confound the protocol-specified efficacy assessments
Binge Drinking Among Youngs is a Risk Factor for Alcohol Use Disorders

The purpose of this study was to assess drinking habits and patterns of alcohol consumption, smoking habits, use of illicit drugs and the prevalence of binge drinking and alcohol use disorders among Italian young students. Furthermore to investigate the correlation between binge drinking and alcohol use disorders.

This study was performed on 2,704 subjects attending high school, through the administration of questionnaires regarding socio-demographic data, anthropometric characteristics, pattern and amount of alcohol intake, smoking habits, use of illicit drugs and physical activity were administered to students. Moreover mood and anxiety were evaluated through AUDIT, STAI-Y1, STAY-Y2 and ZUNG. The aim of the study was to assess drinking habits and patterns of alcohol consumption, smoking habits, use of illicit drugs and the prevalence of binge drinking and alcohol use disorders among Italian young students. Furthermore to investigate the correlation between binge drinking and alcohol use disorders.

Eligibility Criteria:
Inclusion Criteria:

* Subjects attending high school of three italian cities (Rome, Latina, Frosinone)
* Subjects aged between 13 and 19 years
* Subjects that accept the interview

Exclusion Criteria:

* Subjects that don't accept the interview
TART - Troglitazone Atherosclerosis Regression Trial

The purpose of this study is to determine if troglitazone reduces the progression of early preintrusive carotid atherosclerosis in insulin-requiring diabetes patients.

Insulin resistance and hyperinsulinism appear to be important risk factors for the development of atherosclerosis in diabetes patients. The atherogenic potential of insulin has been shown to improve cholesterol and may have an effect on the thickness and structure of the arterial wall. Troglitazone is an oral diabetic agent that treats insulin resistance. Based on the initial data available, it would appear that troglitazone may be effective in both glycemic control and improved atherosclerosis risk in diabetes patients. This study will compare the effects of troglitazone to placebo in insulin-requiring diabetes patients on both glycemic control and progression of atherosclerosis.

A total of 288 men and women 30 to 70 years of age with insulin-treated diabetes were recruited and entered an 8 week run-in phase to stabilize diet, exercise, insulin dose and glucose levels. Upon successful completion of the run-in phase, all patients were randomized into one of two groups to receive either troglitazone 400mg/day or a matching placebo while continuing with diet and exercise regimens and insulin dose to maintain pre-meal glucose levels between 100 to 150 mg/dL.

Follow up visits occurred every 2 weeks for 2 months, every 4 weeks for 2 months, then every 8 weeks for the remainder of the 2-year trial. The progression of atherosclerosis was measured by ultrasonography at baseline and every 6 months throughout the 2 years of randomized treatment.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 30-70 years
* Diabetes: fasting glucose over 140 mg/dL but under 350 mg/dL on at least 2 occasions
* At least 30 years of age at onset of diabetes
* Metabolic control and management requiring insulin without other anti-diabetic medications
* Willingness to sign informed consent

Exclusion Criteria:

* Known sensitivity to troglitazone or other thiazolidinediones
* For premenopausal females: pregnancy, breastfeeding, unwilling to use effective contraception for the duration of the trial
* Active liver disease or hepatic dysfunction; renal dysfunction; high blood pressure; major vascular events within 6 months prior to randomization; untreated hypothyroidism or uncured hyperthyroidism; other severe or unstable disease within 5 years of randomization
* Medical illness that may require oral or parenteral glucocorticoid therapy
* Physical disability that would interfere with diabetes self-management
* Untreated or unstable diabetic retinopathy
* History of insulin allergy
* Present or recent history of alcohol intake over 5 drinks per day or substance abuse
* Participation in another clinical trial
* Currently taking nicotinic acid
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta®

The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

This randomized, double-blind trial compared the proposed biosimilar LA-EP2006 with the reference Neulasta® in women (≥18 years) receiving chemotherapy for breast cancer. Therefore patients were randomized to receive LA-EP2006 (n = 159) or the reference product (n = 157) for ≤6 cycles of (neo)-adjuvant TAC (docetaxel 75mg/m\^2, doxorubicin 50 mg/m\^2, and cyclophosphamide 500mg/m\^2) chemotherapy. The primary end point was the duration of severe neutropenia (DSN) during Cycle 1 (defined as number of consecutive days with absolute neutrophil count \<0.5 × 10\^9/l). The equivalence was confirmed if 95% CIs were within a ±1 day margin. LA-EP2006 was equivalent to the reference product in DSN (difference: 0.07 days; 95% CI \[-0.12, 0.26\]). Further, LA-EP2006 and the reference Neulasta® showed no clinically meaningful differences regarding efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

* histologically proven breast cancer
* eligible for six cycles of neoadjuvant or adjuvant chemotherapy

Exclusion Criteria:

* concurrent or prior chemotherapy for breast cancer
* concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunotherapy, monoclonal antibodies, and/or biological therapy
* concurrent prophylactic antibiotics
* previous therapy with any G-CSF (granulocyte-colony stimulating factor) product

Other protocol-defined inclusion/exclusion criteria may apply.
Comparison of Outcomes of Multiple Platforms for Assisted Robotic-Kidney (COMPAR-K)

The Urology Unit of AOUI Verona proposes a clinical study aimed at a preliminary evaluation of postoperative complications specifically focused on robotic partial nephrectomy (RAPN) procedures using two currently available platforms:

* DaVinci®;
* Hugo®.

The questions it aims to answer are:

Does the estimation of the post-operative complications suggest something? Are differences (intra- and post-operative, oncological, functional, technical, and economic) among the three intervention approaches observable?

Participants will be invited to join one of these two experimental group:

1. surgery with the DaVinci platform;
2. surgery with the Hugo platform.


Eligibility Criteria:
Inclusion Criteria:

* patient aged between 18 and 90 years old;
* patient with localized kidney tumor suitable for partial nephrectomy;
* patient able to understand and sign the informed consent;
* patient compliance with the follow-up program.

Exclusion Criteria:

* patient who do not fall within the inclusion age range;
* patient not suitable for partial nephrectomy;
* patient unable to understand and sign the informed consent;
* patient unable to follow the monitoring program;
* patient refusal to participate to the study.
Angiographic and IVUS Follow-up After Simultaneously Implanted Different Drug-eluting Stents in Same Individuals (AIFSIDDES)

The safety and efficacy of drug-eluting stents (DES) with a biocompatible polymer have been demonstrated in randomized clinical trials as well as in real world practice. Theoretically, a new DES with a biodegradable polymer should reduce the incidence of late in-stent thrombosis, however, the long-term safety and efficacy of these stents remains unknown. This study was aimed to compare the safety and efficacy of the Excel DES with a biodegradable polymer to the Endeavor DES with a biocompatible polymer in same individuals.


Eligibility Criteria:
Inclusion Criteria:

* simultaneous implantation of one or more Endeavor stents and one or more Excel stents during the same index procedure
* willing to be followed up with coronary angiography and intravascular ultrasound at least one year post-procedure.

Exclusion Criteria:

* Patients were excluded from the study if they had more than two kinds of stents implanted or if the two study stents were implanted during separate interventional procedures or in coronary artery bridge vessel or restenotic lesions.
Study in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Occurring After Total Knee Arthroplasty (TKA)

The purpose of this study is to learn about the safety and effects of PLG0206 for treating periprosthetic joint infections (PJI) in conjunction with the DAIR (debridement, antibiotics and implant retention) surgical procedure for patients with periprosthetic joint infections (PJI) after total knee arthroplasty (TKA) .

Peptilogics, Inc. is developing PLG0206 for the treatment of PJIs. PLG0206 is an engineered antibacterial peptide (EAP) based on naturally-occurring antimicrobial peptides (AMPs). Recent work on PLG0206 has documented that PLG0206 is a highly effective anti-biofilm agent, in addition to its established activity against planktonic staphylococcus, both in vitro and in a murine animal model of PJI.

PLG0206 will be investigated in this study for treatment of PJI in conjunction with the DAIR procedure followed by the 6-week course of antimicrobial therapy that is standard-of-care (SOC) in this indication.

Patients will be followed for approximately 1 year post treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with well-fixed prosthesis;
* Patients who have a pre- or intra-operative diagnosis of TKA-PJI

Exclusion Criteria:

* Patients for whom a DAIR procedure is not indicated;
* Patients with loose prosthesis and/or surgical treatment requiring removal of well-fixed, non-modular implants at screening;
* Patients with previous history or presence of osteomyelitis in the index limb;
* Patients who have uncontrolled diabetes mellitus;
* Patients with body mass index \>50 kg/m2 at screening;
* Patients who are immunosuppressed;
* Patients who require therapeutic anticoagulation and/or antiplatelet therapy
Phytoestrogens as an Alternative to Estradiol in Ovulation Induction in PCOS

Prospective study conducted on 150 women with polycystic ovarian syndrome (PCOS) were randomly divided into 3 groups: group I (50 women) received clomiphene citrate (CC) only 50 mg orally every 8 hours started from cycle day 3 for 5 days, group II (50 women) received 2mg estradiol valerate daily from cycle day 7 - 11 in addition to CC and group III (50 women) received phytoestrogen (20mg of cimifuga racemosa from day 1- 12) in addition to CC.

Prospective study conducted on 150 women with PCOS were randomly divided into 3 groups: group I (50 women) received CC only50 mg orally every 8 hours started from cycle day 3 for 5 days, group II (50 women) received 2mg estradiol valerate daily from cycle day 7 - 11 in addition to CC and group III (50 women) received phytoestrogen (20mg of cimifuga racemosa from day 1- 12) in addition to CC.

Eligibility Criteria:
Inclusion Criteria:

Women with both 1ry and 2ry infertility were included. All women were between 20 and 37 years old.

Exclusion Criteria:

women with endocrinological abnormalities as thyroid dysfunction or abnormal prolactin levels, those with hypothalamic or pituitary dysfunctions evaluated by low gonadotropin level, other causes of infertility as tubal factor evaluated by HSG or laparoscopy, abnormal uterine cavity evaluated by sonohystrography or hysteroscopy and male factor evaluated by semen analysis. Women with ovarian cysts were also excluded from the study
Post-Hospital Case Management to Improve Clinical Outcomes in Individuals Requiring Mechanical Ventilation

King County Lung Injury Project: Survivor Outcome Study (KCLIP:SOS) is a randomized trial for individuals who have survived prolonged mechanical ventilation (5 days or more). The objective is to enroll individuals who are likely to have impaired health status resulting from prolonged critical illness but whose long term prognosis is good. Such individuals are most likely to benefit from the study intervention of case management targeted at post intensive care complications.

KCLIP:SOS will test whether an outpatient intervention based on a nurse using a targeted case management tool can reduce patient morbidity and improve quality of life in the 6 months following hospital discharge. This intervention will be compared to usual post-hospital care.

BACKGROUND:

The purpose of this study is to understand individuals' physical and emotional conditions and concerns after being ventilated in the hospital. Modern hospital care helps many people survive even if they are on ventilators for long periods of time. Some individuals who leave the hospital after this kind of intensive care suffer from depression, post-traumatic stress disorder, muscle weakness, tiredness or breathing difficulties that may decrease their quality of life. Doctors know little about finding and treating these problems in survivors of mechanical ventilation.

DESIGN NARRATIVE:

Participants will be randomly assigned in blocks of 10 (5 participants to usual care and 5 participants to case management) for home or skilled nursing facility discharges. The Outcome Assessors (the interviewers collecting outcomes data) will be blinded to group assignment.

Primary outcome: All participants will have a baseline interview soon after hospital discharge and a final interview at the end of the 6-month intervention period (outcome assessments). All subjects will be asked to keep a diary/journal of their medical appointments, health services, and medications. Participants will be called once a month to collect this information.

Key secondary outcomes: Case management participants will be contacted by the nurse case manager who will provide follow-up care for 6 months. At the end of the study, interview results will be sent to the personal physician of the usual care participants so that appropriate care can follow.

Eligibility Criteria:
Inclusion Criteria:

* On a ventilator for 5 or more days
* Expected to survive the 6 months post-hospital discharge period
* Lives in the SOS zip code area (King, Pierce and Snohomish counties)

Exclusion Criteria:

* Severe pre-hospital health conditions
* Lack of availability for follow-up (e.g. homeless, chronic substance abuse)
* Non-English speakers
* Severe psychiatric issues
* Need for special rehabilitation services not available in the intervention
* Predicted survival of less than 6 months