cyrilzakka/clinical-trials huggingface dataset:
Investigation of Chronic Intestinal Ischemia

Patients suspected of chronic mesenteric ischemia caused by atherosclerosis or median arcuate ligament syndrome shall be investigated with trans mucosal and transserosal laser Doppler flowmeter and visible light spectroscopy.

Patients with suspected chronic mesenteric ischemia (included median arcuate ligament syndrome/truncus coeliacus compression syndrome) referred to the vascular surgery department for investigation of splanchnic and mesenteric circulation shall be included in this study.

In addition to CT angiography, patients shall be investigated

1. with gastroscopy-assisted laser Doppler flowmetry and light spectroscopy (GALS) before and after the surgical or endovascular treatment
2. Endoscopic ultrasound before and after the surgical or endovascular treatment
3. Transserosal laser Doppler flowmetry and light spectroscopy during the surgical treatment
4. Plasma Ischemia bio-markers, before and after the surgical or endovascular treatment
5. Health related quality of life assessed with EQ5D and SF36 before and after the treatment
6. clinical outcomes of the treatment (early and late results).

Eligibility Criteria:
Inclusion Criteria:

Clinical chronic mesenteric ischemia caused by either atherosclerosis or median arcuate ligament syndrome

Exclusion Criteria:

Patients unable to go through gastroscopy
Efficiency of a Tight Monitoring by a Nurse Practitioner of Rheumatoid Arthritis (RA) Patients in Remission

Rheumatoid arthritis (RA) is a progressive disease that affects mainly small and medium joints and, in the absence of appropriate background therapy, leads to progressive joint destruction, functional, psychological, social and occupational repercussions.

Several biomedicine treat this pathology, including rituximab (RTX). It is recommended to evaluate the therapeutic response to RTX and re-administer it from the 24th week when the goal of remission has not been achieved. However, the optimal modality for reprocessing remains to be determined.

To this end, different approaches have been explored, such as lymphocyte typing or ultrasound monitoring. The pace of these examinations, however, remains wide and their cost is not negligible. This is why we propose here to explore the track of a tight follow-up nurse DAS28.

The hypothesis is that a tight nursing follow-up can detect the symptomatic recovery earlier than the current medical follow-up.

The hypothesis is that a tight nursing follow-up can detect the symptomatic recovery earlier than the current medical follow-up


Eligibility Criteria:
Inclusion Criteria:

* Male or female (age 18 or older)
* Rheumatoid arthritis fulfilling the ACR/EULAR 2010 criteria
* Patient to whom the rheumatologist prescribed a treatment with rituximab or who received a treatment with rituximab in the last 6 months
* Patients with active rheumatoid arthritis prior to treatment with rituximab (DAS 28 CRP\>2.7)
* Patient with a DAS 28 CRP of less than 2.7 at 6 months from the last administration of rituximab

Exclusion Criteria:

* Patient not responding to the last treatment with rituximab (DAS28 CRP\> 2.7 at 6 months)
* Patient under the age of 18
* Patient with chronic pain due to another pathology than rheumatoid arthritis, which may interfere with the assessment
* Patient with a contraindication to treatment with rituximab
* Woman of childbearing age not taking effective contraception
* Pregnant or nursing woman
Lactate and Complications in Cytoreduction Surgery for Peritoneal Carcinomatosis

Serum lactate is a risk factor for postoperative complications in patients undergoing cytoreduction surgery in peritoneal carcinomatosis

Background. Cytoreduction surgery has been developed as a treatment of peritoneal carcinomatosis. However, this surgery is associated with important complications. The present study attempts to assess the relationship between lactacidemia levels and the rate of associated complications in patients undergoing cytoreduction surgery during the immediate postoperative period in a critical unit.

Methods. Retrospective observational study. 57 patients underwent cytoreduction surgery during the years 2014 and 2015 at the General University Hospital of Castellón. All patients were admitted to the critical unit immediately after surgery. Lactacidemia levels at the time of admission and discharge from the critical unit were collected. Post-surgical complications that appeared during the stay in the critical unit were recorded and classified according to the Clavien-Dindo classification.

Lactacidemia levels were still significantly higher in this group at the time of discharge.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with peritoneal carcinomatosis who underwent cytoreduction surgery in the Multidisciplinary Unit of Abdomino-Pelvic Oncology Surgery (MUAPOS) of the University General Hospital of Castellón.

Exclusion Criteria:

* patients without lactic acid levels in the register.
Treatment and Biomarker Testing Patterns,Treatment Outcomes in a/m NSCLC With and Without Actionable Genomic Alterations

Planned study population consists of approximately 1500 adult patients with a/m NSCLC in Russia, in about 20 oncological centers (in each center it is expected to recruit about 75 patients) in different regions of Russia in order to provide representative study sample


Eligibility Criteria:
Inclusion Criteria:

1. Morphologically confirmed NSCLC with or without actionable genomic alterations (AGA, i.e. EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, RET, ERBB2 (HER2), or KRAS)
2. Age ≥18 years at the time of NSCLC diagnosis;
3. Locally advanced or metastatic disease defined as incident stage IIIB/IIIC/IV NSCLC or stage I-IIIA then progressed to stage IIIB-IV disease and not eligible for curative-intent treatment (the date of progression is included in the database);
4. Available data on at least one line of systemic therapy for advanced/metastatic disease within the period since January 2022 until January 2025;
5. Patients may be alive or deceased at the time of medical record abstraction

Exclusion Criteria:

1. Patients participated or participating in clinical trials or any early access program within period since the index date until the end of study period;
2. Diagnosis of another cancer (except for melanoma/skin cancer) at or within 5 years prior to NSCLC diagnosis or any ongoing systemic anti-cancer therapy regimen at the time of NSCLC diagnosis
Tenofovir, Emtricitabine and Efavirenz Late Switch to a Single Pill: Patients' Opinion Survey

The purpose of this study is to assess adherence, tolerability and satisfaction of each eligible HIV subjects switching from a two- or three-pill tenofovir-emtricitabine-efavirenz (TDF-FTC-EFV) to a one-pill TDF-FTC-EFV treatment.

Each eligible patient will be screened from de SHCS database. Each refusal and drop-out will be documented. A pre-visit (V-1) will be scheduled for informed consent, V0 for inclusion (V-1 and V0 may occur on the same day), V1 one month post-inclusion and V2 4 to 7 months post-inclusion. V0, V1 and V2 will be planned during regular medical visits.

Eligible patients either get their cART in their usual pharmacy according to standard of care, or take part in a routine adherence-enhancing program(adherence subgroup)run by the pharmacists of the outpatient medical clinic.

In the adherence subgroup, adherence is assessed electronically by MEMS (Medication event monitoring system) monitors on a regular basis.

Eligibility Criteria:
Inclusion Criteria:

* patients under TDF-FTC-EFV
* followed up at the Service of Infectious Disease of the University Hospital of Lausanne
* enrolled in the SHCS

Exclusion Criteria:

* patients receiving TDF-FTC-EFV in combination with other ARTs
* patients under TDF-FTC-EFV for less than 3 months
* patients not fluent in French
Therapeutic Equivalence Trial of Two Hormonal-IUDs in Patients With Heavy Menstrual Bleeding

The primary objective of this study was to compare the efficacy of Test Product (Levosert) vs. Reference Product (Mirena® Bayer-Schering) based on the mean variation of menstrual blood loss volume in women with menorrhagia.

The secondary objectives includes physical and gynaecological examinations, vital signs, clinical laboratory tests including hemoglobin and ferritin measurements, body weight and spontaneously reported adverse events were analysed and compared between Levosert and Mirena® treatment arms. Plasma levels of levonorgestrel (LNG) were also evaluated after various periods of time. The residual amounts of LNG in the devices were finally measured after withdrawal at completion of the study. Plasma levels of LNG and residual amounts of LNG were compared between the two treatment groups. Contraceptive effect of Levosert was estimated by Pearl Index.


Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant, non-planning pregnancy, non-lactating non-menopausal females at least 18 years of age.
* Patients with a clinical diagnosis of functional Menorrhagia during the last 6 months.
* Patients who are eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained to them.

Exclusion Criteria:

* History of endometrial ablation or dilatation and/or curettage within the 3 months prior to screening
* Copper - coiled-intrauterine device or LNG releasing IUS use within 2 months prior to screening
* Abnormal liver function or jaundice
* Renal insufficiency
* Other hormonal treatment (sexual steroids),
* Organic causes of abnormal uterine bleeding (presence of endometrial polyps, submucous myomas of any size, or myometrial myomas \> than 3 cm, adenomyosis, atypical hyperplasia, carcinoma)
* Abnormal uterine morphology
* Presence of ovarian cyst \> 3 cm
* Lower genital tract infection
* Current or recurrent PID (present or recurrent pelvis infection (including history of postpartum endometritis, infected miscarriage) during the past 3 months
* Uncontrolled hypertension
* Congenital or acquired valvular disease (including corrections with prosthetic valves)
* Known or suspected pregnancy
* Known or suspected hormone-dependent tumor
* BMI \> 30
* Abnormal Pap smear test or other evidence of cervical/endometrial mancy
* Unexplained amenorrhea
* Known hypersensitivity to device material and/or Levonorgestrel
Empowering Young Parents: Building Healthy Relationships Study

The goal of this trial is to learn how the Safe Dates for Young Parents (SDYP) intervention affects the sexual and reproductive health behaviors, and quality of, and attitudes surrounding intimate partner relationships in adolescents and young adults (AYA) assigned female sex at birth who are pregnant or parenting.

The main questions it aims to answer are:

* Will the SDYP intervention have any effect on the sexual and reproductive health behaviors during the study period?
* Will the SDYP intervention have any effect on the prevention or reduction of intimate partner violence (IPV)?
* Will the SDYP intervention have any effect on the attitudes and beliefs about healthy relationships?

Researchers will compare the behaviors, attitudes, and beliefs about sexual and reproductive health and relationships of participants assigned to the SDYP intervention group to participants assigned to the control (non-SDYP intervention) group to see if there is any difference or changes in those behaviors, attitudes, and beliefs before-and-after or without the SDYP intervention.

Participants in the SDYP intervention will attend ten (10) 50-minute group sessions that will involve interactive discussions, thinking through life-like scenarios, games, role-plays, brainstorming, and a poster contest and theatrical play.


Eligibility Criteria:
Inclusion Criteria:

Adolescent and Young Adult (AYA) \[EYP study participants\]

* Aged 14-21 years (inclusive) at Screening.
* Assigned female sex at birth.
* Currently pregnant or parenting their child who lives with them at least part-time.
* Able to speak and read English or Spanish.
* Able and willing to provide verbal informed consent for enrollment in the EYP study.
* Able and willing to provide adequate contact/locator information.
* Able and willing to complete protocol requirements, including completion of three study interviews over one year.

Study Facilitators (process evaluation participants)

* Aged 18 years or older.
* Trained and served as a facilitator of the SDYP intervention.
* Able to speak and read English.
* Able and willing to provide verbal informed consent.

Exclusion Criteria:

* Per participant report at Screening or Enrollment, intends to travel away from their geographic area of residence for a time period that would interfere with study participation, including with intervention participation should the participant be randomized to the SDYP intervention.
* Has any other condition that, in the opinion of the Principal Investigator (PI) or their designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Low-dose Iron Supplementation in Non-anaemic Iron-deficient Women

The goal of this study is to investigate the efficacy of a low dose iron supplement (6mg) compared to a placebo tablet.

The established therapy for iron-deficiency today is oral iron supplementation. However, this often leads to side effects such as constipation, black stools, nausea, and abdominal pain. There are some studies that have compared the efficacy of low-dose iron with normal-dose iron. These showed that the side effects are dose-dependent. Furthermore, some studies have shown that the uptake capacity of high-dose iron is less efficient due to the upregulation of hepcidin. In a pilot study with low-dose iron (6mg per tablet), a significant increase in iron was shown, which can be explained by a lower hepcidin release. Therefore, the investigators would like to show the efficacy of the low-dose iron product in a placebo-controlled setting. Furthermore, the goal is to examine the reduction of side effects before and after administration of the iron and placebo tablet. Additionally, a potential increase of low blood pressure to normal blood pressure will be investigated. There will be two groups of women: one group will be given a low-dose iron supplement of two tablets containing each 6mg for 3 months (90 days), the other one will get two placebo tablet for 3 months, accordingly.

Eligibility Criteria:
Inclusion Criteria:

* informed consent as documented by signature
* female gender
* premenopausal
* age \> 18 years
* regular menstrual cycle
* BMI in normal range (18-25 kg/m²)
* serum-ferritin ≤30µg/l
* no anaemia (Hemoglobin ≥117g/l)
* no intake of dietary supplements containing iron (last 4 weeks)
* the participant is linguistically and cognitively able to understand the study procedure

Exclusion Criteria:

* Current pregnancy
* breastfeeding
* hypermenorrhea (more than 5 unties/tampons per day)
* chronic inflammatory diseases (e.g. colitis)
* psychiatric disorders
* chronic kidney disease (creatinine \>80 µmol/l)
* liver disease (ALT \>35 U/l)
* increased CRP (\>5mg/l)
* Hypo- or Hyperthyroidism (TSH not between 0.16 - 4.25 mU/l)
* hypersensitivity to iron-supplements
* intake of medicines that interact with oral iron supplementation (e.g. PPI)
A Study of BMS-824393 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype I

Based on 12-week on-treatment data, at least 1 dose of BMS-824393 can be identified which is safe, well tolerated, and has sufficient antiviral activity to progress to late stage clinical trials when combined with pegIFNα/RBV for treatment of chronically infected hepatitis C virus genotype 1 treatment-naive subjects.


Eligibility Criteria:
Inclusion Criteria:

* Treatment-naive subjects with genotype 1 chronic HCV
* HCV RNA ≥ 100,000 IU/mL at screening
* Seronegative for HIV and HBsAg
* Liver biopsy within prior 2 years demonstrating no cirrhosis

Exclusion Criteria:

* Any evidence of liver disease other than hepatitis C
* Diagnosed or suspected hepatocellular carcinoma
* Laboratory values: neutrophil count \< 1500 cells/μL, platelet count \< 90,000/μL; Hemoglobin ≤ 12 g/dL (120g/L) for women and ≤ 13 g/dL (130 g/L) for men
* Cirrhosis
A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets

A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects between the ages of 21 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight \> 45 kg (99 lbs).

Exclusion Criteria:

* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen
Radial Ablation for the Control of Persistent Atrial Fibrillation

The protocol aims to evaluate the efficacy of the radial ablation technique of the maintenance mechanisms in persistent atrial fibrillation compared to the isolation of the pulmonary veins evaluating the atrial fibrillation burden during one year follow-up.

Atrial fibrillation is the most common arrhythmia in clinical practice, and its treatment still remains suboptimal. Electrical isolation of the pulmonary veins with radiofrequency ablation or cryoablation is the standard therapy when antiarrhythmic drugs or electrical cardioversion is not successful. However, recurrence after catheter ablation worsens in persistent and permanent atrial fibrillation patients. Recently, rotational activity electrogram patterns of self-sustained electrical activity found in the atria have been proposed as the responsible mechanism for the maintenance of atrial fibrillation. The investigators devised a controlled, multicentric, prospective, not blinded, and randomized clinical trial with the aim of comparing pulmonary vein catheter ablation versus radial ablation of sites exhibiting rotational activity in patients with persistent atrial fibrillation. Radial ablation consists of the ablation of the rotational activity sites and an additional ablation line connecting the rotation site with the circumferential ablation line of the pulmonary veins.

Besides, subanalysis ARTIST-Gender and ARTIST-HF will be performed. ARTIST-Gender will compare the same outcomes and analysis of the patient cohort but according to the gender of the patient, and ARTIST-HF will sub-divide the analysis with respect to heart failure present in the enrolled patients' cohort.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and ≤ 75 years.
* Non-valvular symptomatic persistent atrial fibrillation.
* Patient willingness to participate in the study providing signed written informed consent.
* Failure or drug intolerance or refusal to continue with chronic antiarrhythmic treatment.
* Left ventricular ejection fraction LVEF) ≥ 25 % in the last echocardiogram prior to enrollment.

Exclusion Criteria:

* Left atrial diameter \> 5.5 cm in the last echocardiogram.
* Contraindication of chronic anticoagulation or heparin.
* Previous atrial fibrillation ablation procedure.
* Acute coronary syndrome, cardiac surgery or acute cerebrovascular accident in two months prior to enrollement.
* Previous diagnosis for hyperthyroidism or hypothyroidism.
* Mental or physical illness that disables the patient to participate in the study.
* Scheduled cardiac percutaneous or surgical intervention.
* Non-controlled hypertension \> 160/100.
* Terminal renal insufficiency or dialysis.
* Functional class IV of the New York Heart Association (NYHA).
* Moderate valvular disease or previous mitral prosthesis.
* Previous hypertrophic heart disease.
* Life expectancy less than 12 months.
* Inclusion on the transplant list.
* Participation in another study so as not to interfere with the results.
* Previous atrioventricular block.
* Pericardial effusion.
* Pregnancy or childbearing age without contraceptive treatment.
DFD01 Spray HPA Axis Suppression Study in Adolescent Patients With Moderate to Severe Plaque Psoriasis

To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the hypothalamic-pituitary-adrenal (HPA) axis when applied twice daily for 15 days or when applied twice daily for 29 days, in adolescent subjects with moderate to severe plaque psoriasis under maximal use conditions.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must weigh at least 55 pounds
2. Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
3. Subjects with psoriasis involving ≥ 10% BSA, not including the face, scalp, groin, axillae and other intertriginous areas..
4. Subjects must have moderate to severe plaque psoriasis at the Baseline Visit.
5. Subjects whose results from the screening ACTH stimulation test are considered normal (cortisol level \>18 ug/dL at 30 minutes post stimulation) and show no other signs of abnormal HPA axis function or adrenal response.

Exclusion Criteria:

1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
2. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
3. Have received treatment for any type of cancer within 5 years of the Baseline Visit.
4. Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea), or 3) biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, secukinumab, or alefacept).
5. Use within 30 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (salicylic acid, anthralin, coal tar, calcipotriene), 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy.
6. Use within 30 days prior to the Screening Visit of any product containing corticosteroids. Inhaled, intraocular, intranasal, etc. steroids are not allowed.
7. Subjects who have an abnormal sleep schedule or work overnight.
8. Subjects with a known history of acute adrenal crisis, Addison's disease or decreased adrenal output, low pituitary function or pituitary tumors.
9. Subjects who have a history of an adverse reaction to cosyntropin injection or similar test reagents.
The Effect of Varied Intensities of Breastfeeding Peer Support on Duration of Breastfeeding Among Oregon WIC Participants

The U.S. Surgeon General has recommended that peer counseling to support breastfeeding become a core service of the Supplemental Nutrition Program for Women, Infants and Children (WIC). As of 2008, 50 percent of WIC clients received services from local WIC agencies that offered peer counseling. Little is known as to the effectiveness of these peer counseling programs. Randomized controlled trials of peer counseling interventions among low-income women in the U.S. showed increases in breastfeeding initiation and duration, but it is doubtful that the level of support provided could be scaled up to service WIC clients nationally. The investigators tested whether a telephone peer counseling program among WIC participants could increase breastfeeding initiation, duration and exclusivity.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant Oregon WIC participants in Jackson, Washington and Hood River counties or Umatilla Morrow Head Start.

Exclusion Criteria:

* WIC participant outside of the 4 study agencies.