cyrilzakka/clinical-trials huggingface dataset:
Hysterectomy and OPPortunistic SAlpingectomy

HOPPSA is a register based randomized controlled trial (R-RCT), with the objective to examine if opportunistic salpingectomy compared with no salpingectomy, at the time of hysterectomy for a benign reason

* has no increased risk of complications
* has no negative side effects on ovarian function and subsequent cardiovascular disease or incidence of fractures
* implies reduced risk of subsequent ovarian cancer Randomization and follow-up will be conducted within national registers.

High grade serous ovarian cancer, the most fatal subtype, may originate in the fimbriae of the Fallopian tubes. This theory has led to the idea of opportunistic salpingectomy as a way of decreasing the risk of epithelial ovarian cancer (EOC). HOPPSA is a national register-based RCT, with randomization and follow-up in The Swedish National Quality Register of Gynecological Surgery (Gyn/Op).

HOPPSA aims to study if opportunistic salpingectomy is safe, and if it can reduce the risk of EOC.

PICO P (patients). Women \<55 years, undergoing hysterectomy due to a benign reason I (intervention). Bilateral salpingectomy at the time of hysterectomy C (comparison). No salpingectomy O (outcomes). Primary short term: surgical complications reported according to Clavien-Dindo at 8 weeks post-operatively Intermediate term: change in menopausal symptoms from baseline to 1 year, assessed with Menopause Rating Scale Long term: ovarian cancer assessed through the National Cancer Register Recruitment of 4400 patients is estimated to take 4-6 years depending on the participation rate of the Swedish gynecological clinics. Data retrieval from GynOp on short and intermediate term outcomes, requiring smaller sample sizes, will be done at the end of the recruitment period. If these results, ready available when the study recruitment is closed, show that opportunistic salpingectomy does not increase surgical complications and menopausal symptoms, women can be advised to undergo salpingectomy to potentially minimize the future risk of EOC.

Eligibility Criteria:
Inclusion Criteria:

* Planned hysterectomy for a benign reason
* Age \< 55 years at randomization
* Willing to be randomized
* Vaginal route may be included if the surgeon is confident with performing vaginal salpingectomy.

Exclusion Criteria:

* Previous bilateral oophorectomy and/or salpingectomy
* Planned oophorectomy and/or salpingectomy (for reasons such as already diagnosed adnexal tumor, known carrier of the breast cancer susceptibility gene (BRCA) 1/2 mutation or Lynch syndrome (hereditary nonpolyposis colorectal cancer))
* Non-understanding of the oral or written study information
Retinol Equivalence of Plant Carotenoids in Children

To determine vitamin A value of beta-carotene in oil capsule, spinach, and golden rice.

The experiments will be conducted in children (ages 7-9) with/without adequate vitamin A nutrition. As plant provitamin A carotenoids are a major and safe vitamin A source for a vast population in the world, it is essential to determine the efficiency of provitamin A carotenoid (mainly ß-C) conversion to vitamin A. By introducing ß-C into rice endosperm, Golden Rice may directly benefit consumers by providing vitamin A nutrition. Our investigation uses hydroponically grown, deca-deuterium labeled spinach and Golden Rice, synthetic ß-C-d10 and a vitamin A isotope reference, deca-deuterated retinyl acetate (RAc-d10), to evaluate the bioavailability and the bioconversion of plant provitamin A carotenes to retinol as compared with ß-C in oil capsules in vivo.

Our objectives will be to test the following hypotheses and to make the following determinations: (1) The absorption and bio-conversion of provitamin A carotenes taken by children are different between spinach, Golden Rice, and ß-C in oil capsules. (2) The absorption of provitamin A carotenes and their bioconversion to vitamin A are different in children with or without adequate vitamin A nutrition. (3) To define the vitamin A equivalence(s) of dietary spinach, Golden Rice, and a ß-C in oil dose by using an isotope reference method in children with or without adequate vitamin A nutrition and to compare those values with values derived from model based compartmental analysis. (4) To determine the number and time of blood samples needed for future studies in various field settings on the retinol equivalence of a large number of plant sources.

This study will be of importance in planning vitamin A deficiency prevention strategies and also will provide useful information regarding the potential efficacy of a bioengineered crop to provide vitamin A nutrition.

Seventy-two children each will take two meals, lunch and supper, containing equal amounts of ß-C in labeled spinach (along with white rice), or Golden Rice (along with light colored vegetables), or ß-C oil capsules (along with white rice and light colored vegetables), every day for 7 days. Before the two meals, the volunteers will take a breakfast with a RAc-d10 dose as a reference for 7 days. The enrichment of labeled ß-C and labeled retinol in human circulation will be determined using advanced liquid chromatography / mass spectrometry and gas chromatography / mass spectrometry. Through the applications of these novel technologies, we will be able to determine the relative biological activities of endogenous carotenoids; that is, the vitamin A value of spinach, Golden Rice, and ß-C in oil capsules for children with/without vitamin A malnutrition.

Eligibility Criteria:
Inclusion Criteria:

* 7-9 years old

Exclusion Criteria:

* Parasitic infection
Acute Effect of Topical Menthol on Neck Pain

Topical menthol gels are classified 'topical analgesics' and are used to relieve aching and tenderness of muscles and joints. However, double-blind randomized controlled trials are lacking. Here the investigators examine - in a double-blind randomized controlled cross-over trial - the acute effect of topical menthol (Biofreeze) and placebo (gel with a menthol scent) on neck pain.


Eligibility Criteria:
Inclusion Criteria:

* more than 30 days with neck pain during the last year
* frequent pain or discomfort, defined as at least 3 days per week
* pain intensity at least 4 on a scale of 0-10
* working at least 30 hours per week

Exclusion Criteria:

* blood pressure above 160/100 mmHg
* pregnancy
* life-threatening disease
Mecillinam for Treatment of Genital Chlamydia Infection

The mainstay of treating both symptomatic and asymptomatic genital Chlamydia trachomatis infection has been macrolide antibiotics in the form of azithromycin, and alternatively tetracycline antibiotics in the form of doxycycline. Studies from the late nineties found a single dose of 1 g azithromycin to be equally effective as a 7 day course of 200 mg doxycycline a day. However, recent studies have reported increasing treatment failure that may indicate that resistance to macrolide antibiotics among Chlamydia trachomatis is evolving. Research regarding other bacterial species indicates a high frequency of mutation based resistance in conjunction with azithromycin use, i.e. when treating Mycoplasma genitalium infections. There has only been case reports of tetracycline resistance among human Chlamydia isolates, but a recent study suggest that there might be decreasing effectiveness also for doxycycline. Veterinaries has for several years observed increasing prevalence of tetracycline resistance among Chlamydia suis. Within the Chlamydia population there is promiscuous horizontal gene transfer.

If the current trend of declining cure rates continues, the investigators might face a situation where there are no documented and effective treatments for Chlamydia trachomatis infections. This underline an urgent need to expand the number of documented treatment options and mecillinam seems to be one of the options that warrant further investigation.

The objectives of this study is to prove the concept of treating genital Chlamydia trachomatis with mecillinam (Pivmecillinamhydrochlorid).


Eligibility Criteria:
Inclusion Criteria:

* Proficient in oral and written Norwegian
* Positive NAAT in first void urine for Chlamydia trachomatis
* Negative NAAT in first void urine for Mycoplasma genitalium
* Heterosexual male
* Asymptomatic

Exclusion Criteria:

* Known allergies for mecillinam, penicillin or cephalosporines
* Metabolic anomalies of aciduric type
* Apparent underweight
* Use of mecillinam within the last two months
* Under treatment with Valproat, other anti-infective drugs, immuno-modulating medication
* In the opinion of investigator,obvious reasons why patient will fails to adhere to treatment and follow-up protocol
Evaluating Modulation Effects of Temporal Interference Using SEEG

This single-center prospective study aims to investigate the electrophysiological mechanisms of temporal interference (TI) in humans by analyzing clinical, imaging, and electrophysiological data from patients aged 14-60 with drug-resistant epilepsy.

Temporal Interference (TI) technology is a novel non-invasive method for deep brain stimulation (DBS). By generating an overlapping electric field from safe currents, TI creates focused stimulation in targeted deep brain areas. This approach allows for the exploration of deep brain nuclei functions and has the potential to serve as a non-invasive alternative to traditional invasive DBS for clinical treatments.

Stereoelectroencephalography (SEEG) is a method for recording electrical activity from deep brain structures using implanted depth electrodes to provide a three-dimensional view of neuronal activity.

This study aims to investigate the electrophysiological mechanisms of temporal interference (TI) deep brain stimulation by including patients aged 14-60 with implanted intracranial electrodes. During and after TI stimulation, electrophysiological and clinical data will be recorded. Clinical, imaging, and electrophysiological data will be analyzed and processed to advance understanding of TI's effects in deep brain stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of drug-resistant epilepsy;
* No severe systemic diseases;
* Implantation of stereotactic electrodes;
* Agreement to participate in this study and signs the informed consent form.

Exclusion Criteria:

* Hematoma at the scalp electrode site or fluid accumulation under the electrode after intracranial electrode placement.
Phase II Study of Modified Triple Doublet Therapy in Women With Newly Diagnosed Mullerian Carcinoma

Over the last few years several novel agents have been defined which are active in the treatment of relapsed epithelial ovarian carcinoma. Many of these new agents seemed to have mechanisms of action that are different from Carboplatin and taxol. This trial looks to evaluate the effectiveness and toxicity of three sequential chemotherapy doublets in the treatment of women with newly diagnosed ovarian, primary peritoneal or tubal carcinoma.

Objective: To evaluate a novel regimen in ovarian carcinoma with an aim of demonstrating a higher than 50% laparotomy defined response rate. This rate is defined as the proportion of patients achieving either a pathologic complete response or a microscopic positive second look at the conclusion of therapy.

Primary study goals:

· To determine the efficacy of a triple doublet regimen in carefully defined cohorts of patients as defined by the surgical defined response rate

Secondary study goals:

* To evaluate incidence of tubulin mutations in primary and secondary surgical specimens.
* To evaluate changes in IL-6, IL-8, VEGF, and FGF, at primary diagnosis, during and at the conclusion of therapy.
* To describe initial IL-6, IL-8, and FGF levels in patients who ultimately achieve pathologic remission vs those with gross residual disease.

Patients will recieve 3 cycles of carboplatin and gemcitabine followed by 3 cycles of taxol and carboplatin and then three cycles of adriamycin and topotecan. All patients with a clinically complete response will then undergo second look operation to determine pathologically defined response.

* SLO = Second Look Operation

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed epithelial carcinoma of müllerian origin. Specifically, ovarian, primary peritoneal and tubal carcinoma will be allowed. All histologic subtypes are eligible.

  * Patients must have undergone an attempt at aggressive surgical debulking or alternatively be eligible for interim debulking after cycle #3. Patients debulked to no evidence of disease, microscopic disease or gross residual disease are eligible.
  * Stage II, III or IV disease. Patients with disease outside the abdominal cavity are eligible unless presentation includes brain metastases.
  * Able and willing to undergo a second look staging laparotomy.
  * Patients must give written informed consent.
  * Patient must be ag· Performance status (ECOG) \>2.
  * Previous chemotherapy.
  * Creatinine \> 1.5
  * History of recent MI or congestive heart failure within 6 months of surgery
  * SGOT \> 2x ULN, bilirubin \> 1.5 X ULN
  * Concurrent invasive malignancy. (Patients with concurrent superficial endometrial carcinoma are eligible if their endometrial carcinoma is superficial or invades less than 50% the thickness of the myometrium).
  * Known hypersensitivity to E.coli derived products?
  * Active psychiatric or mental illness that makes informed consent or careful clinical follow-up unlikely e 18 years or older.
  * Adequate bone marrow function with an ANC \> 2,500 and Platelets \>100,000/mm3.

Exclusion Criteria
Study of Kidney Circulating Cell-free DNA in Patients With Acute Kidney Failure

The amount of total circulating DNA has been shown to increase in patients with acute renal failure. Nevertheless, it is currently not currently possible to prove the renal origin of this circulating DNA. Recently, in healthy subjects, teams have shown that it is possible to identify its tissue origin of circulating DNA. CGenetix is a MedTech company which develops on an identical principle an in vitro diagnostic test capable of identifying and quantifying renal degradation during an acute trauma. The objective of this study is to evaluate the sensitivity of the proposed technology to detect circulating DNA of renal origin released into the general circulation in patients with acute organic and functional renal failure. Patients with functional or organic kidney deficiency will be included and the kidney biomarkers develop by CGenetix will be compared between these 2 groups of patients.

When the patient arrives, a first stage of checking the inclusion/non-inclusion criteria will be respected. Patients who do not meet the eligibility criteria will not be sampled (pre-screening stage).

Patients meeting the eligibility criteria will be informed of the study by the investigator and a written information note will be given to them. If they do not object to their participation, an additional tube of blood for research purposes will be taken during a blood sample taken as soon as they are admitted as part of their usual treatment. They will also follow the standard care protocol according to the clinical recommendations of their attending physician. The objective of early sampling is to sensitize the test by assaying the marker as soon as possible after renal injury. In the event of a posteriori differential diagnosis (obstructive ARF or IRC), the patient will be excluded from the final analysis.

Patients passing the pre-screening and screening stages positively will be included in the final analysis.

90 patients should be included and divided into 2 groups:

* 65 patients with non-biopsied organic acute kidney injury of which 20 patients with biopsied organic acute kidney injury (test group)
* 25 patients with functional acute kidney failure (control group).

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Admitted for suspicion of acute renal injury (organic) and/or with an indication for renal biopsy (PBR)
* Patients hospitalized with functional acute renal failure (negative control and inclusion limited to n = 30 maximum)

Exclusion Criteria:

* Patients \< 18 years old
* Patients with cognitive and mental disorders making them unable to express their non-objection to participation in the study
* Patients with obstructive renal failure
* Patients with chronic renal failure
* Patients who expressed their refusal to participate in the study
CASH (Cavernous Angiomas With Symptomatic Hemorrhage) Trial Readiness

Brain Cavernous Angiomas with Symptomatic Hemorrhage (CASH) are rare, but they exact a heavy burden of neurologic disability from recurrent bleeding, for which there is no proven therapy. This trial readiness project aims to address current critical obstacles in identifying cases at multiple sites, characterizing their relevant features, and measuring their outcome. The timing cannot be more opportune, with therapeutic targets already identified, exceptional collaboration among researchers and with the patient community, and several drugs ready to benefit from a track to clinical testing in the next five years.

The Trial Readiness grant mechanism, funded by NINDS, proposes to address knowledge gaps and establish a research network as infrastructure for future research. This project includes an observational cohort study of 181 patients with an operational goal of demonstrating the feasibility of screening, enrollment rates, baseline disease categorization and follow-up of CASH using common data elements at multiple sites, and to assess the following endpoints for 123 participants enrolled at centers prespecified to do prospective follow-up: (1) the rates of recurrent hemorrhage; (2) the reliability of imaging biomarkers including quantitative susceptibility mapping and permeability measures which have been shown to correlate with lesion activity, and (3) change in functional status during prospective follow-up.

Eligibility Criteria:
Inclusion Criteria

1. 18 years of age and older
2. Diagnosed with a brain CA (single or multiple)
3. Had a SH within the past year (with demonstrated new lesional bleeding or hemorrhagic growth on diagnostic studies AND attributable new symptoms)
4. Subject is able to provide informed consent

Exclusion Criteria

1. Spinal CA as source of SH
2. Prior brain irradiation
3. Cases where verification of SH with clinical and imaging review cannot be accomplished
4. Prior or planned treatment of the symptomatic lesion (after neurosurgical consultation)

To be eligible for Aims 2 and 3, CASH cases enrolled in Aim 1 will be further excluded from follow-up and baseline validation (FUBV) for the following reasons:

1. Contraindication for administration of contrast agent or otherwise unwilling or unable to undergo research MRI studies
2. Pregnant or breastfeeding women
3. Homeless or incarcerated persons, or other reason a subject will be unable/unlikely to return for follow-up visits
A Pragmatic Clinical Trial Comparing the Risk of Acute Kidney Injury During Treatment With Vancomycin and Piperacillin-Tazobactam vs. Vancomycin and Cefepime in Hospitalized Patients

Hospitalized patients with suspected or confirmed infection are commonly treated with vancomycin (VN) in combination with either piperacillin-tazobactam (PT) or cefepime (CP). Although these regimens have similar effectiveness, recent observational evidence suggests they may differ in terms of the risk for acute kidney injury (AKI). Interpretation of existing evidence is complicated by the limitations of creatinine, the standard biomarker used to monitor kidney function, which has poor sensitivity and specificity for drug induced AKI. To address this important knowledge gap, the investigators propose to conduct a pragmatic, open-label, non-inferiority trial that will examine the comparative risk of AKI between these standard-of-care antibiotic combinations using sensitive and specific markers of drug-induced AKI. We hypothesize that the regimen of VN in combination with PT (VN+PT) is noninferior to the regimen of VN in combination with CP (VN+CP) in terms of AKI risk.


Eligibility Criteria:
Inclusion Criteria:

1. Age of at least 18 years
2. Suspected or confirmed infection based on clinical criteria, for which vancomycin with piperacillin-tazobactam or vancomycin with cefepime was prescribed by the treating clinician, as evidenced by orders being placed in the electronic health record
3. The treating clinician considers both vancomycin with piperacillin- tazobactam or vancomycin with cefepime as acceptable treatment
4. The treating clinician anticipates at least 48 hours of antibiotic treatment

Exclusion Criteria:

1. Dialysis dependence or documented end stage kidney disease
2. AKI at baseline
3. Expected survival \<24 hours and/or presence of do not resuscitate orders
4. History of antibiotic-resistant organisms (microbiological culture results showing bacterial isolates with resistant or intermediate susceptibility to any study drug within the prior 90 days)
5. Documented allergy to vancomycin, cephalosporins, or penicillin
6. Suspected central nervous system infection
7. Inability to provide informed consent or lack of proxy for consent
8. Prisoners/incarcerated individuals
9. Known pregnancy or breastfeeding
10. Previous enrollment in this study
11. Receipt of vancomycin, piperacillin-tazobactam, or cefepime for \>24 hours within the preceding 7 days. At the time of screening, one-time doses of vancomycin, with or without piperacillin-tazobactam, or cefepime, will be allowed prior to randomization to avoid treatment delays; such patients must be enrolled within twelve hours of antibiotic administration.
Transcutaneous Levator Recession for Non-thyroid Lid Retraction

This work aims to describe and assess the efficacy of transcutaneous levator palpebrea superioris muscle recession as a surgical procedure for treatment of upper lid retraction of various causes other than thyroid eye disease


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from upper eyelid retraction of various causes other than thyroid eye disease

Exclusion Criteria:

* Patients refused to participate in the study, patients with systemic diseases causing lid retraction (such as Guillain-Barré syndrome), pseudo retractions, contralateral ptosis, local skin condition (as scar adherence), medication (such as sympathomimetic drugs, lithium, and steroid), neurological conditions (such as dorsal midbrain syndrome and hydrocephalus) and thyroid related lid retraction