cyrilzakka/clinical-trials huggingface dataset:
Antidepressant Prophylaxis for Interferon-Induced Depression: Efficacy of Paroxetine

Objectives:

1. To determine whether paroxetine can prevent major depression in patients with hepatitis C (HCV) who are receiving pegylated-interferon (Peg-IFN).
2. To determine whether paroxetine can prevent subsyndromal increases in depression and anxiety in patients with HCV who are receiving Peg-IFN.
3. To determine whether paroxetine can prevent a significant change in the health related quality of life in patients with HCV who are receiving Peg-IFN.
4. To determine whether paroxetine improves compliance with Peg-IFN therapy for HCV.
5. To determine whether paroxetine enables patients to complete Peg-IFN therapy for HCV who might otherwise require a dose reduction or discontinuation because of neuropsychiatric side effects.


Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* diagnosis of hepatitis C
* agree to participate in the study with written informed consent
* plan to undergo treatment with Peg-IFN + Ribavirin
* compensated liver disease (hemoglobin value \> 12 gm/dL for females or \> 13 gm/dL for males, WBC \> 3000/mm3, platelets \> 70,000/mm3, albumin \> 3.0 g/dL or within 20% of LLN, Serum creatinine \< 1.4 mg/dL, thyroid stimulating hormone within normal limits
* confirmation from female patients that adequate contraception is being practiced during treatment period and for 6 months after discontinuation of therapy
* confirmation from male patients that acceptable contraception is being practiced

Exclusion Criteria:

* hypersensitivity to IFN, RBV, or paroxetine
* chronic liver disease other than chronic HCV
* hemolytic anemia from any cause including hemoglobinopathies
* evidence of advance liver disease
* any preexisting medical condition that could interfere with participation in the protocol
* evidence of cardiac ischemia, a significant unstable cardiac arrhythmia, heart failure, recent coronary artery surgery, uncontrolled HTN, unstable angina, or MI within past 12 months
* clinically significant retinal abnormalities
* substance abuse (must have abstained from abusing substance for at least 6 months)
* diagnosis of major depression in the past 6 weeks
* currently receiving full therapeutic dose of antidepressant medications
* diagnosis of bipolar disorder
* active psychotic condition
* active delirium
* pregnant female patients, men whose sexual partner is currently pregnant, and men and women who are not practicing adequate contraception
* female patients who are actively breast feeding
* patients with a known history of non-compliance with medical treatment
Administration of Acetazolamide to Prevent Remifentanil Induced Hyperalgesia

Remifentanil is a potent opioid widely used during the administration of general anesthesia. There is a lot of evidence that suggest that the used of remifentanil is associated with the development of hyperalgesia (a reduction of nociceptive thresholds). However, the mechanism of this hyperalgesia is not fully understood.

Recently, it was demonstrated that the disruption of the Cl- homeostasis could be involved. Interestingly, this was prevented in a murine model with the administration of Acetazolamide, a carbonic anhydrase inhibitor. In our clinical trial we will try to determine if the preoperative administration of acetazolamide could prevent the hyperalgesia induced by remifentanil in patients scheduled for thyroidectomy with general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for thyroidectomy with general anesthesia in the University of Chile Clinical Hospital

Exclusion Criteria:

* Patients ASA III y IV
* Chronic pain history
* Drug and alcohol abuse
* Chronic use of opioid and sedatives
* Neuropsychiatric illness
* NSAID and other analgesics used the 48 hours previous to the surgery
* CMI \> 30
Inflammatory Markers After COloRectal Surgery)

The clinical symptoms of septic complications (SC) (responsible for the majority of morbidity in colorectal surgery) become apparent only 5-7 days after the operation, whereas the efficacy of treatment depends on early diagnosis. By detecting such complications early it could be possible to reduce their severity, the length of hospitalisation, repeat colostomy and the number of readmissions. Our team has shown that C-reactive protein (CRP) \> 125 mg/L at postoperative day 4 (D4) was a predictor of SC in this context. Procalcitonin (PCT) is a marker of sepsis currently used in intensive care, but its use in the follow-up of elective surgery, particularly colorectal surgery, has not been fully evaluated.

The aim of this study is to compare the ability of CRP and PCT to detect SC as early as postoperative day 2 (D2) (intra-abdominal or systemic SC, such as those defined by the CDC) after elective colorectal surgery.

Adult patients about to undergo elective colorectal surgery with anastomosis will be included once they have given their written informed consent. Levels of CRP and PCT will be measured the day before the surgery, then at D1, D2, D3 and D4. The clinical data (temperature, recovery of bowel movement, pain, pain on palpation) will be recorded daily. Imaging examinations will be performed at the discretion of the surgeon; the only obligation will be to perform a contrast-enhanced abdominopelvic CT-scan if CRP at D4 \> 125 mg/L with no other clinical anomalies. The discriminating ability (measured by the area under the ROC curve) of CRP at D2 was 0.653 in our previous study. An improvement of at least 0.1 will be necessary to show the superiority of PCT over CRP in clinical terms and with regard to the cost.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective colorectal surgery with anastomosis for benign or malignant disease
* \> 18 years old
* Giving written informed consent
* Included in the national health insurance

Exclusion Criteria:

* Emergent surgery
* Previous infection
* Patients undergoing Hyperthermic Intraperitoneal Chemotherapy
* Pregnancy
Neurophysiological Effects of Transcutaneous Electrical Nerve Stimulation in Persons With MS

Transcutaneous Electrical Nerve Stimulation (TENS) is a treatment that could potentially reduce walking problems and fatigue in persons with Multiple Sclerosis. However, extensive use of TENS in a clinical setting is hindered by a lack of neurophysiological understanding of the effects of TENS. The primary objective of this pilot study is therefore to investigate the effects of TENS on brain activity in pwMS measured with fMRI.

This study is an exploratory study to see if we can detect changes in fMRI activity during TENS in persons with MS. This is a randomized, single-blind crossover design. Subjects will undergo an MRI scan while they receive sham stimulation of the tibialis anterior, active stimulation of the tibialis anterior, stimulation of the quadriceps, perform continuous movements of the foot (plantar \& dorsiflexion) and a combination of stimulation of the tibialis anterior and movement of the foot. This study will include 15 subjects with relapsing remitting or progressive MS and 15 healthy controls. Blood-oxygen-level-dependent (BOLD) activation changes and the interaction networks before, during and after active TENS and differences in activation due to stimulation on quadriceps vs. tibialis anterior, stimulation on tibialis anterior vs plantar/dorsiflexion and stimulation on tibialis anterior vs stimulation combined with plantar/dorsiflexion. This will be compared between pwMS and healthy controls. This study can add to the limited knowledge and possibly help to personalize and implement TENS in the clinic.

Eligibility Criteria:
Inclusion Criteria:

* age: 18-65 years
* EDSS score \< 7

Exclusion Criteria:

* metal or electrical implants
* BMI \> 40
* claustrophobia
* being pregnant
* having a psychiatric disorder
* having cognitive or communication problems which reduces the capacity to understand instructions
* having a neurological disorder other than MS
* having cardiac arrhythmia
Microparticle Generation After Laparoscopic Surgical Treatment for Endometrioma.

Study objective: To evaluate serial generation of microparticles (MPs) after laparoscopic stripping or CO2 laser vaporization in surgical treatment of patients with ovarian endometrioma (OE).

Design: A prospective, randomized, blinded, pilot study, including 33 patients. Setting: Tertiary university hospital from April 2015 to June 2017. Patients: 33 women with unilateral OE undergoing laparoscopic surgery. Intervention: Patients were randomly selected to undergo either CO2 laser vaporization (L group) or laparoscopic stripping (S group) of OE.

Measurements and Main results: Blood samples were collected before surgery, and at 2 hours, 24 hours, 1 month, and 3 months after surgery. MPs generation curve after ovarian endometrioma surgery was performed.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 40 years and unilateral symptomatic OEs ≥3 cm.

Exclusion Criteria:

* previous pelvic surgery, history of cancer, suspected malignancy, presurgical suspicion or evidence of deep endometriosis, presurgical suspicion or evidence of premature ovarian failure, and the use of estrogen suppressive drugs, including oral contraceptives, GnRH-agonists, progestins, or danazol in the preceding 3 months. We excluded patients with suspicion of deep endometriosis according to an extensive preoperative work-up (including magnetic resonance imaging when necessary) routinely performed in such patients.
Food is Medicine for Patients with Heart Failure

This study will look at the effects of providing medically tailored meals (MTMs) to people with heart disease for twelve weeks. The primary outcome of the study is the quality of the diet being consumed in week 12 of the study, as determined by the "Healthy Eating Index."

This study will look at the effects of providing medically tailored meals (MTMs) to people with heart disease for twelve weeks. Sixty adults with heart failure will be recruited from the San Diego and San Francisco Bay Area of California. They will be randomly assigned to two groups: 1) a group that receives 15 "medically tailored meals" plus snacks each week for 12 weeks, 2) a group that receives 14 "medically tailored meals" each week for 12 weeks. The primary outcome of the study is the quality of the diet being consumed in week 12 of the study, as determined by the "Healthy Eating Index". Many other secondary outcomes will be assessed including both qualitative factors (e.g., satisfaction, preferences, adherence) and quantitative clinically measures (e.g., blood cholesterol, blood pressure, weight).

Eligibility Criteria:
Inclusion Criteria:

* Willingness to comply with all study procedures and availability for the duration of the study
* Living in San Diego or the Bay Area of California
* Reported congestive heart failure (CHF) diagnosis
* Current diet can be improved
* Willing to eat all meals provided by the study

Exclusion Criteria:

* Diagnosed with end-stage heart failure
* Diagnosed with diabetes (type 1 or uncontrolled type 2)
* Currently taking insulin and/or meglitinides medications
* Hemoglobin A1c (HbA1c) results \>8 %
* Life expectancy of \<1 year
* Pregnancy or lactation
* Known severe allergic reactions and/or food intolerances that would interfere with the ability to eat study-provided meals, including foods that are prepared in a facility that works with the allergen
* Current smoker or tobacco use within the past year
* Planning to leave San Diego or the Bay Area during the course of the study
* Unable to communicate reasonably well either orally or through written material in English
* Those who, in the opinion of the investigators, cannot reliably complete the study protocol
E-health-supported Diagnostic and Intervention in Preterm Born Children and Their Families

The app-based diagnostic and support approach with a focus on mental and somatic symptoms is intended to strengthen the resilience of premature born children and families and to identify risk and resilience factors.The overall objective of the study is to improve the post-inpatient care of families with premature born children. The procedure is evaluated by a two-arm design with an experimental group and a TAU group.

The project aims to conduct a longitudinal study of premature babies and their parents from the time of hospital discharge in order to identify predictive factors for their psychological and physical outcomes and to provide individualized interdisciplinary diagnostic and treatment. The project helps to identify risk and protective factors and also takes a closer look at the interplay between the mind and body. This care approach is supported by an app that records symptoms and needs and also allows contact with the study team. The app also provides psychoeducational materials. The study was developed in collaboration with affected families and experts from the aftercare team. The concept will be evaluated by comparing the treatment group with a TAU group and by conducting measurements after hospital discharge, after 4 months, and again after 7 months, as well as through focus groups with study participants.

Eligibility Criteria:
Inclusion Criteria:

* Premature babies born at the UKT,
* Gestational age 28-34 weeks,
* Mother: age ≥ 18 years,
* agreement to participate in this study and signing of a consent form,
* sufficient knowledge of German,
* internet access

Exclusion Criteria:

* Premature babies \< 28th or \>34th week of pregnancy,
* at least one of the children has serious diseases of the nervous system or obvious symptoms of a nervous disease,
* at least one of the children has serious congenital diseases or suffers from malformations,
* Mother: Lack of access to a smartphone/tablet,
* no internet access,
* insufficient knowledge of German
A 2-part Study to Assess Local Tolerability, Safety and Pharmacokinetics of Ceftaroline in Healthy Subjects

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of Ceftaroline 600 mg when administered by varying infusion volumes.

A Phase I, Single-center, 2-part, Randomized, 2-way Crossover Study to Assess the Local Tolerability and Safety (Multiple-dose) and to Assess the Pharmacokinetics, Safety, and Tolerability (Single-dose) of Ceftaroline in Healthy Subjects when Ceftaroline Fosamil is Diluted in Various Infusion Volume

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific requirements
* Women of childbearing potential must have a negative pregnancy test, be non-lactating, and be using a highly effective form of birth control for 3 months prior to enrollment, during the study, and for 3 months after completion of all study-related proceed
* Male volunteers must be willing to use barrier contraception from the first day of dosing until 3 months after the last dose of IP.
* Have a body mass index (BMI) between 18 and 30 kg/m2, and weigh at least 50 kg
* Healthy male and/or female volunteers between the ages of 18 to 75 years inclusive, with veins on the back of both hands and both forearms suitable for cannulation or repeated venipuncture.

Exclusion Criteria:

* Use of any other investigational compound or participation in another clinical trial within 1 month prior to first administration of IP in this study
* History of any clinically significant disease or disorder (e.g., neurological, haematological, psychiatric, gastrointestinal, hepatic, renal disease)
* Positive serology result on screening for serum hepatitis B surface antigen, hepatitis C antibody (HCV), or human immunodeficiency virus (HIV)
* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
* Any clinically significant abnormalities in the physical examination, lab, 12-lead ECG or vital signs as judged by the investigator
Optimizing Pain Control in Transurethral Resection of the Prostate

The purpose of this study is to develop a multi-modal protocol for pain management after TURP that minimizes opioid use. The investigators hypothesize this approach will provide non-inferior pain control to the current standard of care which includes opioids as the primary agent. The investigators believe this is an important step in reducing the opioid epidemic in surgical patients.

In our study, the investigators will randomize TURP patients to standard of care versus a multi-modal protocol. Multi-modal pain control is defined as: "analgesia that combines 2 or more agents that act by different mechanisms to provide analgesia with better pain relief and less opioids". In addition, patients in the intervention arm will receive education regarding pain control and opioid use. The investigators aim to demonstrate non-inferior pain control with this approach. The investigators hope this will inform new guidelines for pain control after TURP, minimize opioid use in this patient population, and educate physicians and patients on providing excellent pain control while minimizing the risks of opioid use. The investigators believe this could ultimately serve as a model for other endoscopic urologic procedures as well.

Eligibility Criteria:
Inclusion Criteria:

* Are identified as candidates for TURP
* Are 18 years of age or greater
* Are proficient in English

Exclusion Criteria:

* Have filled an opioid prescription in the last 2 months
* Have an allergy to a medication included in the protocol
* Have a history of pelvic radiation
* Have renal failure (Serum Cr \> 2.0 mg/dl), peptic ulcer disease, history of gastric bypass, cirrhosis, or other contraindication precluding use of NSAID's
* Have liver failure, hepatitis, or alcohol abuse which precludes use of acetaminophen
Prostatic Size Reduction Following of Leuprorelin Acetate

To determine the possible reduction in prostate size following the administration of Leuprelin prior to the application of radiotherapy.

Prostate cancer (PC) is the most common tumor in men worldwide, including our country, with an incidence of 34,413 cases in 2020 (70.6 per 100,000 inhabitants) . The elevation of Prostate-Specific Antigen (PSA) in blood and/or an abnormality in rectal examination necessitate a prostate biopsy, the diagnostic procedure involving the extraction of a small prostate tissue sample for microscopic analysis and classification of cancer cells according to the Gleason scale (malignancy grade).

Once diagnosed, extension studies (thoraco-abdominal CT, Bone Scintigraphy, PET Choline, etc.) are conducted to rule out metastasis, the spread of tumor cells originating in the prostate, to other organs. The majority of PC cases are diagnosed at localized stages (without distant disease), allowing for local curative treatments such as surgery (Prostatectomy) and radiation therapy (Prostate Radiotherapy).

Hormonal androgen blockade (HAB) combined with radiation therapy improves oncological outcomes for localized PC . Additionally, HAB administered before radiation therapy results in a reduction in prostate gland size . This reduction allows for a decrease in the volume to be irradiated, leading to lower toxicity on surrounding healthy tissues and organs (primarily the bladder and rectum).

This apparent volume reduction is expected two months after initiating HAB, typically coinciding with the simulation CT scan for radiotherapeutic treatment planning. However, there are no studies certifying or quantifying this reduction and its subsequent benefits in PC treatment.

Currently, comparing prostate size pre- and post-HAB is challenging. The first measurement is obtained from ultrasound and/or MRI at the time of diagnosis, while the second measurement (post-HAB) is only taken during radiotherapist oncologist planning CT. This poses two problems: the inadequacy of comparing prostate sizes between different tests, and potential discrepancies in prostate delineation due to variations among different participating radiation oncologists.

Eligibility Criteria:
Inclusion Criteria:

Man with Prostate positive biopsy. Able to Ssgned informed consent form. Need of hormonal treatment before start of radiotherapy

Exclusion Criteria:

Patients With prostate size of less than 20 cc at diagnosis. Patients With Positive lymph nodes or metastatic prostate cancer disease on imaging studies.

Patients with Previous pelvic radiation therapy.
Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease

The purpose of this study is to determine whether a combination therapy with angiotensin-converting enzyme (ACE)-inhibitors and angiotensin receptor blockers reduces the arterial stiffness assessed by applantiontonometry more than a single treatment in kidney patients.


Eligibility Criteria:
Inclusion Criteria:

* Creatinine: 150-350 micromol/L
* Blood pressure \> 110 systolic
* Negative pregnancy test for fertile women
* Written and oral informed consent from the patient

Exclusion Criteria:

* Treatment with both ACE-inhibitors (ACE-I) and angiotensin receptor blockers
* Pregnancy or breastfeeding
* Treatment with immunosuppressive medication, steroids or non-steroidal anti-inflammatory drugs (NSAIDs)
* Serious chronic heart failure (New York Heart Association \[NYHA\] III-IV)
* Chronic liver disease
* Suspicion or verified kidney artery stenosis
* Cardiac arrhythmia and/or implanted pacemaker
* Myocardial infarction or cerebrovascular incidence within the last 3 months
* Allergy towards ACE-I or angiotensin receptor blockers
* Amputation of a whole extremity or the crural or femoral part of the leg
* Dementia or a psychological condition that makes understanding of the examination conditions impossible
* Dialysis or renal transplantation
* Treatment with aldosterone antagonists
* Hyperkalemia \> 5.5 mmol/l
* Another serious chronic non-renal disease