cyrilzakka/clinical-trials huggingface dataset:
Superior Hypogastric Plexus Blockade in Laparoscopic Hysterectomy

The primary indication for superior hypogastric plexus (SHP) block is visceral pelvic pain, most commonly from malignancy of the ovary, uterus, cervix, bladder, rectum or prostate. Per-cutaneous SHP blocks should be done under guidance of ultrasonography, fluoroscopy, magnetic resonance or computed tomography. During minimally invasive laparoscopic surgery, percutaneous technique can be done under the guidance of cameras.

Laparoscopic surgeries have many advantages over open surgeries. Laparoscopic procedures are mostly preferred for surgical treatment of gynecologic diseases, because of best cosmetically results, less perioperative complications, early recovery, and less postoperative pain.

There are many undesirable effects of systemic reactions to the pain. Accordingly, multi-modal analgesic approach (including nerve blocks) for postoperative acute pain can decrease the side effects of the drugs (especially opioids) significantly.

The primary indication for superior hypogastric plexus (SHP) block is visceral pelvic pain, most commonly from malignancy of the ovary, uterus, cervix, bladder, rectum or prostate. Per-cutaneous SHP blocks should be done under guidance of ultrasonography, fluoroscopy, magnetic resonance or computed tomography. During minimally invasive laparoscopic surgery, per-cutaneous technique can be done under the guidance of cameras.

SHP block has been performed by anesthetists or surgeons in Kocaeli Derince Training and Research Hospital regularly since they have discovered the advantages of this block technique. SHP can be useful to decrease postoperative pain scores and opioid or NSAID consumption significantly.

Eligibility Criteria:
Inclusion Criteria:

* ASA I - II
* Elective laparoscopic hysterectomy

Exclusion Criteria:

* ASA III
* Different kind of surgery
* Known allergy to local anesthetic drugs
* Different analgesia protocol (ie: epidural, TAP block,..)
* Refusal of the patient
Prevalence of Hyponatremia in Dengue Infected Patients: Relationship With Systemic Inflammation.

Prospective cohort study in patients with newly diagnosed dengue infection at Hospital Posadas in Argentina, between January 1, 2016, and November 1, 2023. Diagnosis was confirmed by IgM serology or PCR. Hyponatremia was defined as serum sodium concentration ≤135 mEq/L.

Background Dengue infection is becoming more prevalent worldwide and is associated with systemic inflammation. Systemic Inflammation is associated with non-osmotic release of ADH.

Methods: Participants conducted a prospective cohort study in patients with newly diagnosed dengue infection at Hospital Posadas in Argentina, between January 1, 2016, and November 1, 2023. Diagnosis was confirmed by IgM serology or PCR. Hyponatremia was defined as serum sodium concentration ≤135 mEq/L.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis confirmed by PCR, non structural protein 1 (NS1) antigen or IgM serology.

Plasma sodium at admission.

Exclusion Criteria:

* None
Sirolimus Eluting ORSIRO Stent Versus Biolimus-eluting NOBORI Stent

The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) is to compare the safety and efficacy of the sirolimus eluting ORSIRO stent and the biolimus-eluting NOBORI stent in a population-based setting, using registry detection of clinically driven events

SORT OUT VII is a randomized, multicenter, all-comer, two-arm, non-inferiority trial comparing the sirolimus eluting ORSIRO stent to the biolimus-eluting NOBORI stent in treating atherosclerotic coronary artery lesions.

Primary Endpoint:

Target lesion failure within 12 months of stent implantation (combination of cardiac death, myocardial infarction (not index procedure related) not related to other than index lesion or target lesion revascularization).

Secondary Endpoints:

Individual components of the primary end point comprised the secondary end points and stent thrombosis rate according to the Academic Research Consortium definition (see protocol for further specification of secondary endpoints).

Clinically driven event detection will be used to avoid study-induced reinterventions. Data on mortality, hospital admission, coronary angiography, repeat percutaneous coronary intervention, and coronary bypass surgery will be obtained for all randomly allocated patients from the following national Danish administrative and healthcare registries: the Civil Registration System; the Western Denmark Heart Registry; the Danish National Registry of Patients, which maintains records on all hospitalizations in Denmark; and the Danish Registry of Causes of Death

Inclusion criteria:

at least 18 years old chronic stable coronary artery disease or acute coronary syndromes at least one coronary artery lesion with more than 50% diameter stenosis requiring treatment with a drug-eluting stent

Exclusion criteria:

life expectancy of less than one year allergy to aspirin, clopidogrel, sirolimus, or biolimus participation in another randomized trial nability to provide written informed consent

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or over with chronic stable coronary artery disease or acute coronary syndromes, and at least one coronary artery lesion with more than 50% diameter stenosis, requiring treatment with a drug-eluting stent. There are no restrictions on number of treated lesions, number of treated vessels, or lesion length.

Exclusion Criteria:

* Exclusion criteria are life expectancy of less than one year; an allergy to aspirin, clopidogrel, ticagrelor, prasugral, sirolimus, or biolimus; participation in another randomized trial; or inability to provide written informed consent
An Active Approach to Treat Amblyopia: Video Game Play

Amblyopia, a developmental abnormality that impairs spatial vision, is a major cause of vision loss, resulting in reduced visual acuity and reduced sensitivity to contrast. This study uses psychophysical measures to study neural plasticity in adults with amblyopia.

Amblyopia, a developmental abnormality that impairs spatial vision, is a major cause of vision loss, resulting in reduced visual acuity and reduced sensitivity to contrast. Our previous findings (see CITATIONS) show that the adult amblyopic brain is still plastic and malleable, suggesting that active approach is potential useful in treating amblyopia. The goal of this project is to assess the limits and mechanisms of neural plasticity in amblyopic spatial vision. This study uses psychophysical measures to study neural plasticity in adults with amblyopia. Research participants will be asked to play video games with the amblyopic eye for a period of time. A range of visual functions will be monitored during the course of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adults with amblyopia (Age \>15 years)
* Amblyopia: interocular visual acuity difference of at least 0.1 logMAR
* All forms of amblyopia: Strabismic, anisometropic, refractive, deprivative, meridional amblyopia

Exclusion Criteria:

* Any ocular pathological conditions (eg macula abnormalities, glaucoma), nystagmus
PDS vs Polyamide for Midline Abdominal Closure

Within the last decade the customary trend of using non absorbable sutures has changed, with numerous studies and meta-analyses advocating the use of slowly absorbable sutures, claiming comparable wound strength with significantly lower incidence of wound complications. It was the objective of this randomized clinical trial to compare two universally accepted suture materials, the non-absorbable Nylon and the slowly absorbable Polydioxanone for midline abdominal closure in the Indian context.

64 patients undergoing midline laparotomy were allocated, using block randomization, to mass closure of the abdominal wall with continuous polyamide (34 patients) or continuous polydioxanone (30 patients).

There was an alarmingly higher incidence of wound dehiscence in the PDS group requiring secondary suturing (Nylon 0; PDS 5). Mid-way through the trial, an interim analysis was performed which revealed an unacceptably high incidence of wound dehiscence in the PDS group. This necessitated a premature curtailment of the study. There was, however, a statistically significantly higher incidence of scar pain in the Nylon group (Nylon 9; PDS 1).

There is a need for a study with larger series, and PDS as a choice of suture for midline wound closure cannot be recommended.

Eligibility Criteria:
Inclusion Criteria:

* All patients above 12 years of age undergoing midline abdominal fascial closure using a continuous technique in the Department of Surgery, Christian Medical College and Hospital

Exclusion Criteria:

* All patients under 12 years of age
* Gynaecological operations
* Abdominal wall hernia repair
A Study to Evaluate the Effects of YM872 on Brain Function and Disability When Administered in Combination With Alteplase (Tissue Plasminogen Activator)

The purpose of this study is to determine if YM872 in combination with t-PA can reduce disability and brain damage from stroke. YM872 or placebo will be given as a continuous intravenous (iv) infusion for 24 hours. It is important that the study medication, YM872 or placebo, is administered prior to the completion of the t-PA administration. The clinical effects of YM872 in addition to t-PA will be determined by assessing neurological function and disability scores at follow up visits through Day 90 of the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute ischemic stroke who are treated with alteplase within 3 hours of stroke onset (Onset is defined as the time that which the patient was last seen in a normal state, or bedtime for unwitnessed strokes occurring during the night).
* Patients who are able to provide written informed consent or have consent provided by a legally authorized representative.
* Patients who are at least 18 years of age.
* Patients who have a National Institutes of Health Stroke Scale (NIHSS) score of at least 7 but not more than 23 and who are conscious.
* Other criteria as specified in the study protocol

Exclusion Criteria:

* Patients who are not eligible to receive treatment with alteplase (t-PA) due to brain hemorrhage, risk for hemorrhage, or other criteria.
* Patients who have stroke of the brainstem or cerebellum.
* Patients who have renal (kidney) disease or insufficiency.
* Patients who have active epilepsy or convulsions during the current stroke episode.
* Patients who are IV drug users or are inebriated.
* Patients who have a history of drug-related anaphylaxis.
* Patients who have taken sedatives, anticonvulsants, or any medication with sedating effects in the 10 days prior study enrollment.
* Patients who have taken more than 1.3 g of aspirin per day in the 2 days prior to enrollment.
* Patients who have a known vitamin hypersensitivity.
* Other exclusion criteria as specified by the study protocol
Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Colorectal Cancer

GENCONCOR-1 study is translational research aimed to investigate the concordance of the molecular genetic profile of the primary tumor and brain metastases (BM) of colorectal cancer (CRC). The study was conducted by post hoc analysis of pairs of samples of histological material with determination of the mutational status of genes KRAS, NRAS, BRAF, HER2 and MSI.

Brain metastases (BM) from colorectal cancer (CRC) are a rare event reported in less than 3% of patients with CRC (the reported incidence ranges from 0.27 to 3%). This course is associated with a poor prognosis. Treatment of these patients remains challenging. Nevertheless, given the rarity of the event, at this time not enough is known about molecular biology of BM from colorectal cancer and its concordance with matched primary tumors.

In N.N. Blokhin National Medical Research Center of Oncology over 26 years (1998-2024) identified 108 patients with BM from CRC. Of this number, 72 patients had a history of neurosurgical resection of BM. In turn, for 32 patients access to a pair of tumor samples: from the primary tumor and from intracranial metastases. Tumor samples will be tested for mutation status of genes KRAS, NRAS, BRAF, HER2 and MSI. Analysis was limited to this pool of genes because of their clinical relevance and potential prognostic information. The molecular profile of the BM will be compared with the corresponding primary tumor with calculation of concordance rate (%).

Eligibility Criteria:
Inclusion Criteria:

1. Men and women over 18 years of age.
2. Histologically confirmed cancer of the colon or rectum.
3. Histologically confirmed metastatic lesion of the brain.
4. Neurosurgical resection for brain metastases of colorectal cancer.
5. Presence of paired tumor samples (both primary tumor and intracranial material).

Exclusion Criteria:

1. Missing one sample from a pair of tumor samples.
2. Low quality or lack of tumor material for molecular genetic research.
Motivation, Syringe Exchange, and COVID-19

People who inject drugs (PWIDs) are highly vulnerable to SARS-CoV-2 infection and to the disease caused by SARS-CoV-2, coronavirus disease 2019 (COVID-19), however, rates of SARS-CoV-2 testing and vaccination uptake -vital to mitigating the spread of COVID-19 and achieving herd immunity - are lower among PWIDs compared to the general population. Building on our Phase I Rapid Acceleration of Diagnostics project, which found that contingency management (CM) increased testing utilization among PWIDs, the proposed project evaluates the comparative effectiveness of CM versus CM plus a brief motivational enhancement intervention on SARS-CoV-2 testing and vaccination uptake among PWIDs. This project has the potential to reduce COVID-19 health disparities among PWIDs and to decrease population level COVID-19 morbidity and mortality.

This study uses contingency management, specifically $10 financial incentives for participation in SARS-CoV-2 testing and $10 for participating in COVID-19 vaccination. It also uses a motivational enhancement intervention which is a brief conversation with clients to improve intrinsic motivation for testing and vaccination. Thus, the clinical trials portion of this study is a randomized control trial (N = 349) in which 177 participants will be assigned to contingency management plus the Connect2Test intervention and 172 will be assigned to the contingency management alone (i.e. services as usual). There will be a per site quota to ensure there are relatively equivalent numbers of participants per site to avoid site-specific biases. The data collection software (e.g., Qualtrics, PowerBI) will randomly assign individuals to condition in real time, after a participant consents to participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* 18 and older, understand English

Exclusion Criteria:

* none
The Effect of Good Bacteria on Nonalcoholic Fatty Liver Disease in Diabetics

The purpose of this study is to determine whether probiotics, bacteria that may improve liver health, can effectively treat a chronic condition in diabetics that increases fat in the liver.

Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the United States and is also common in diabetics; unfortunately, research on NAFLD has been limited. Safe, inexpensive, and well-tolerated treatments for NAFLD are needed. Recent studies indicate that probiotics help to improve fat breakdown in mice. This study will evaluate the efficacy of probiotic therapy to reduce fat accumulation in the livers of people with NAFLD and diabetes.

Participants in this study will be randomly assigned to receive either a probiotic-containing mixture or placebo once daily for 6 months. Blood tests, and magnetic resonance spectroscopy will be used to assess participants at study start and at study completion.

Eligibility Criteria:
Inclusion Criteria:

* Nonalcoholic fatty liver disease

Exclusion Criteria:

* Any cause of liver disease other than hepatic steatosis
* Diabetes
* Known or suspected cirrhosis
* Inability or unwillingness to undergo magnetic resonance procedures
* Requirement of long-term antibiotic therapy
* Pregnancy, breast-feeding, or plans to become pregnant
Helping Young Children Sleep

The investigators are conducting a randomized trial of behavioral treatments for young children with insomnia. The investigators are comparing the improvement in sleep patterns after families are given access to Internet sleep instructions compared to DVD sleep instructions.


Eligibility Criteria:
Inclusion Criteria:

* 6-36 months
* difficulties falling asleep or staying asleep
* DVD and internet access

Exclusion Criteria:

* Under 14 pounds
* Requires nighttime feeding or parental intervention for health reasons
* Chronic medical or psychological conditions such as asthma or autism
* Parents prefer co-sleeping
Conservative Therapy of Proximal Phalanx Fractures - Comparing the Lucerne Cast With Finger Splinting

The purpose of this prospective randomized controlled clinical trial is to evaluate if the lucerne cast leads to a better functional outcome than a forearm cast with a finger splint in patients with a proximal phalanx fracture.

This study represents a prospective randomized controlled clinical trial comparing two different conservative treatment options in patients with proximal phalanx fractures.

Patients meeting the inclusion criteria will be enrolled in the present study provided they give their consent. Informed written consent will be obtained. Randomization will be performed according to the CONSORT Guidelines of Prospective Randomized Trials using the software "Randomizer" by the Medical University of Graz. Patients allocated to the control group will receive a forearm cast with a finger splint, while patients in the study group will receive the lucerne cast. Both groups will receive the allocated cast for 4 weeks. Clinical outcome will be assessed 12 weeks after trauma.

Eligibility Criteria:
Inclusion Criteria:

* Proximal phalanx fracture in the fingers (II - V)
* Patient age between 18 and 70 years

Exclusion Criteria:

* Condylar fracture
* Avulsions of the collateral ligament
* Pathologic fracture
* Intraarticular fracture
* Patients unable to consent
* Polytraumatized patients
* Patients initially presenting more than 7 days after injury
* Pregnancy
* Compound fractures
* Multiple hand injuries
Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)

The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to linezolid in the treatment of adults with acute bacterial skin and skin structure infections.


Eligibility Criteria:
Inclusion Criteria:

* Patients, ages 18 years or older who have signed the informed consent
* Has a qualifying skin and skin structure infection
* Female patients must not be pregnant at the time of enrollment
* Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug

Exclusion Criteria:

* Infections where the outcome is strongly influenced by factors other than protocol-defined treatment and procedures, that require antibacterial treatment for greater than 14 days
* Evidence of significant immunological disease
* Severe sepsis or septic shock
* Has a history of hypersensitivity or allergic reaction to any tetracycline or to linezolid
* Has received an investigational drug within past 30 days
* Women who are pregnant or nursing
Impact on the Quality of Life and Persistent Symptoms of Patients Away From Diagnosed and Treated Neuroborreliosis

The link between Lyme neuroborreliosis (NBL) and persistent symptoms is debated in the medical world. Some report a frequency of post NBL symptoms similar to the general population, and others define a specific entity, the PTLDS (Post Treatment Lyme Disease Symptoms).

In France, few studies have evaluated the persistent symptoms and the impact on the quality of life of patients after treatment for NBL.


Eligibility Criteria:
Inclusion Criteria:

* Have been hospitalized or consulted for neuroborreliosis between 2010 and 2021;
* Have a diagnosis of probable neuroborreliosis (compatible clinical signs + lumbar puncture with positive intrathecal synthesis of immunoglobulins) or certain (compatible clinical signs + lumbar puncture with pleocytosis and positive intrathecal synthesis of immunoglobulins);
* Have received adequate treatment according to the recommendations (1st intention DOXYCYCLINE 100mgx2/day or 2nd intention CEFTRIAXONE IV 2g/day for 14 to 21

Exclusion Criteria:

* Be part of the entourage of the cases;
* Do not have ATCD of Lyme borreliosis (especially erythema migrans);
* Not having been bitten by a tick in the last 5 years;
University of Wisconsin Solution Versus New Parathyroid Transport Solution for Parathyroid Allotransplantation

Compare the functionality of new parathyroid transport solution (NPTS) with University of Wisconsin Solution (UW) on parathyroid glands. Also assess its effects on cell viability, parathormone (PTH) secretion, calcium-sensing receptor (CaSR) and vitamin D receptor (VDR) levels during cold ischemia.

Parathormone (PTH) and vitamin D are two critical hormonal regulators of calcium homeostasis. There is an important relationship between the PTH release and vitamin D receptor for controlling hormonal systems. Also calcium-sensing receptor plays a crucial role in regulating parathormone secretion which means controlling the calcium-dependent systemic ion homeostasis.

Cold ischemia protects organs and tissues by slowing their metabolism. The cold ischemia of the transplant tissue is a very important process. The University of Wisconsin (UW) solution substantially improves graft preservation and consequently increases patient survival. The researchers newly developed NPTS for transportation of parathyroid glands.

For the comparision the researchers measured the parathyroid cell viability and the calcium sensing and vitamin D receptor density of the parathyroid cells at the 0, 6, 12 and 24 hours of cold ischemia.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have parathyroid hyperplasia due to chronic renal failure.

Exclusion Criteria:

* Patients who refused to join the study
* Patients younger than 18 years and older than 80 years.
* Patients who have hepatitis B,
* Patients who have hepatitis C,
* Patients who have human immunodeficiency virus (HIV).