cyrilzakka/clinical-trials huggingface dataset:
The Effect of High Frequency Jet Ventilation (HFJV)During Laparoscopic Operations

Investigators conducted a randomised perspective study to determine whether the use of HFJV instead of conventional mechanical ventilation will reduce the adverse cardiovascular effects of pneumoperitoneum during laparoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Healthy patients, undergoing laparoscopic surgery for Symptomatic cholecystolithiasis.

Exclusion Criteria:

* ASA 3 and 4
Anti-CD3 & Anti-CD7 Ricin A Immunotoxin-Combination for Acute Graft Versus Host Disease

In this study, a combination of two T-cell directed antibodies both conjugated to a cell-killing toxin will be evaluated. Previous in vitro studies have demonstrated that this so-called immunotoxin-combination (IT-combination) acts synergistically in eliminating T cells. In a subsequent clinical pilot-study, the IT-combination has generated encouraging results when applied as third line therapy. Extensive biological and clinical responses could be noted in the absence of severe acute toxicities. Building on this experience, the current study aims at evaluating the characteristics of the IT-combination when administered in an earlier phase of the disease, i.e. as second line instead of as third line therapy.

"The experimental design is a non-controlled multicentric fixed-dose Phase I/II study. A total of 12 evaluable patients will be enrolled in 4 transplant centers throughout the Netherlands, in a 9 to 12 months period. The treatment consists of a standard dose of 4 infusions IT-combination (4 mg/m2), given 48-hours apart over a 4-hour period.

The intended follow-up period is 12 months. The patient will also be asked to participate in additional research aiming at determining the presence and evolution of biomarkers suggestive for the extent to which the IT-combination 'resets the T-cell compartment, induces clinical tolerance, and/or enhances the risk of over-immunosuppression."

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from severe acute GVHD (Grade II-IV) progressing after 3 days, or non-improving after 5 days, of prednisolone at 2 mg/kg a day.
* Age ≥ 18 years.
* Patients or their guardians should have given written informed consent using forms approved by the Institutional Review Board.

Exclusion Criteria:

* Patients receiving concomitant investigational therapeutics/prophylaxis for acute GVHD at the time of enrollment.
* Patients with histological signs/symptoms suggestive of chronic GVHD.
* Patients requiring mechanical ventilation, requiring vasopressor support, requiring hemodialysis, having serum creatinine \> 266 μmol/l (\> 3 mg/dl), or having a serum albumin level of 20 g/l or less.
* Patients having uncontrolled bacterial, viral or fungal infections at the start of therapy.
* Patients with current evidence of active intrapulmonary disease.
* Patients with known hypersensitivity to any of the components of the study drug (murine mAb or RTA).
* Patients who are pregnant, breast feeding, or, if sexually active, unwilling to use effective birth control for the duration of the study.
Granisteron Versus Metoclopramide in Laparoscopic Cholecystectomy

Study aims at comparing the effect of granisteron with that of metoclopramide in patients undergoing lab cholecystectomy

Post operative nausea and vomitting is Avery common complication of laparoscopic surgery in that study we will compare between granisteron and metoclopramide as aprophlaxis against post operative nausea and vomitting

Eligibility Criteria:
Inclusion Criteria:

* both sexes Age between 18 and 60 years ASA1 2 3 Lap cholecystectomy under general anesthesia

Exclusion Criteria:

* patients refusal Pregnancy and breastfeeding Hepatic or renal disease ASA4 5 Allergy to the drug
Extended Follow-up of Women Who Received One, Two, and Three Doses of the HPV Vaccine in the Costa Rica Vaccine Trial (CVT), ESCUDDO-CVT Study

This study is extending follow up of women who participated in the Costa Rica Vaccine Trial (CVT) and received one dose or two doses of the human papillomavirus (HPV) vaccine, along with a group of women who received three doses. It also studies the stability of HPV defenses in these groups of women for up to 20 years after initial vaccination. Studying samples of blood in the laboratory may provide information on how long one, two, and three doses of the vaccine provide protection against HPV. The results of this study may also help researchers learn whether one dose of HPV vaccine is enough to protect against HPV.

PRIMARY OBJECTIVES:

I. Estimate the change in antibody levels between years 11 and 20. II. Estimate the proportion of individuals who become seronegative (i.e.: serorevert) between years 11 and 20.

SECONDARY OBJECTIVES:

I. Assess the prevalence and distribution of type-specific HPV infections at least 18 years after HPV vaccination.

II. Assess the number and type of premalignant lesions present at least 18 years after vaccination.

III. For each dose regimen, characterize HPV-specific memory B cells and long-lived plasma cells present at least 18 years after HPV vaccination, and compare these characteristics with results from earlier time points.

OUTLINE: This is an observational study.

Patients complete a short questionnaire regarding risk factors for HPV infection and undergo collection of blood samples for testing HPV16 and HPV18 levels on study.

Eligibility Criteria:
Inclusion Criteria:

* Participation in the CVT Long Term Follow-Up (LTFU) study

Exclusion Criteria:

* A random subset of the three-dose women
Relationship Between Nutritional Status, Hand Grip Strength, and Fatigue in Hospitalized Older Adults With Type 2 Diabetes Mellitus.

As the proportion of the elderly population increases, so does the number of people suffering from diabetes mellitus (DM). Fatigue is common in elderly patients with type 2 diabetes, and malnutrition may lead to a decrease in muscle strength, thereby aggravating their fatigue symptoms; however, there is still a lack of relevant research on this group in Taiwan. Therefore, the purposes of this study are to understand the current status and correlation of basic attributes, nutritional status, handgrip strength and fatigue in hospitalized older adults with type 2 diabetes mellitus.

Diabetes mellitus (DM)is increasing among the elderly population in Taiwan, and fatigue is a common troublesome symptom that likely impacts their quality of life and diabetes self-management. Malnutrition is one of the causes of fatigue symptoms in the elderly, and the worse the nutritional status, the worse the hand grip strength performance; the better the grip strength performance, the lower the degree of fatigue symptoms. It can be inferred that the worse the nutritional status, the worse the handgrip strength, which will in turn have an aggravating impact on fatigue symptoms. According to previous literature, handgrip strength may be an important mediating variable between nutritional status and fatigue. However, there are still no relevant studies on hospitalized older adults with type 2 diabetes mellitus.

Therefore, the purposes of this study are to: (1) understand the basic attributes, nutritional status, handgrip strength and fatigue symptoms in hospitalized older adults with type 2 diabetes mellitus. (2) explore the correlation between nutritional status, handgrip strength and fatigue symptoms in hospitalized older adults with type 2 diabetes mellitus, so as to serve as a reference for future clinical care to improve fatigue in elderly patients with type 2 diabetes mellitus.

This study adopted a cross-sectional, correlational design, using structured questionnaires and a Camry Digital Handgrip Dynamometer to collect data. Participants will be recruited from a metabolism \& endocrinology ward at a medical center in northern Taiwan using purposive sampling. The Chinese version of a structured questionnaire, including the demographic and clinical characteristic form, the Mini Nutritional Assessment , and the Fatigue Symptom Inventory will be used. A sample of 54 participants with type 2 diabetes mellitus will be recruited.

Eligibility Criteria:
Inclusion Criteria:

* People who are aged 60 or above
* Diagnosed with type 2 diabetes mellitus
* Conscious and agree to participate in the study.

Exclusion Criteria:

* People who have a cognitive impairment or unable to communicate
* Unable to use the handgrip dynamometer with their dominant hand
* Under active treatment for cancer.
Chronic Remote Ischemic Conditioning in Vascular Cognitive Impairment: A Dose Escalation Study

To evaluate the dose-response of relevant blood biomarkers to remote ischemic conditioning in patients with age-related cerebral white matter hyperintensities on MRI, in preparation for a subsequent larger efficacy trial.

Objective: The objective of this early phase study is to evaluate the dose-response of relevant blood biomarkers to remote ischemic conditioning in preparation for a subsequent larger efficacy trial. In addition, we will evaluate the tolerability and adherence to the treatment protocol.

Aim: We aim to measure blood biomarkers in response to daily remote ischemic conditioning (RIC) using a dose escalation study design in 40 patients with age-related cerebral white matter hyperintensities on MRI.

Hypothesis: We hypothesize that there will be a significant change in the biomarker levels in a dose dependent fashion.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥55 years
2. Head MRI in the past 6 months showing no more than moderate age related cerebral white matter changes (Fazekas score 0-2).
3. Able to walk without assistance \& independently perform basic activities of daily living.
4. Able to understand this study and agree for a valid consent.

Exclusion Criteria:

Prior non-lacunar (cortical) stroke. 2. Unable to cooperate with the use of the conditioning device. 3. Confounding illness that might interfere with the interpretation of results (such as active malignancy or multiple sclerosis).

4. Contraindication to transient arm ischemia in either arm (such as symptomatic peripheral artery disease).
Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension

This is an open-label, nonrandomized extension to study AC-066A301. The study will assess safety and tolerability of ACT-385781A while providing a means for continuing treatment after ending participation in study AC-066A301.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent prior to initiation of any study-mandated procedure
2. Patients who completed participation in study AC-066A301
3. Patients who have not obtained access for commercial EFI at the time of ending participation in study AC-066A301

Exclusion Criteria:

1. Patients who prematurely discontinued study drug in study AC-066A301
2. Patients for whom continued treatment with EFI is no longer considered appropriate
Short-term Effects of Good Metabolic Control on Cognitive Function, Wellbeing, and Metabolic Parameters in Adult Patients With Phenylketonuria

The goal of this study is to evaluate if in adult patients with phenylketonuria (PKU) without strict metabolic control during the last 12 months, strict metabolic control for 8 weeks results in an improvement of cognitive function.


Eligibility Criteria:
Inclusion Criteria:

* Men and women with classical PKU
* Age ≥ 18 years
* Good metabolic control during childhood (at least until 12 years of age)
* Plasma Phe levels ≥ 15 mg/dl for ≥ 1 year
* Written informed consent prior to study participation

Exclusion Criteria:

* Reduced cognitive function (unability to perform test battery)
* Drug and or alcohol abuse
* Treatment with BH4
* Treatment with drugs known to affect cognitive function
Efficacy and Safety in Patients With Primary IgA Nephropathy Who Have Completed Study Nef-301 (Nefigard-OLE)

This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in patients with IgAN who have completed the Phase 3 Study Nef-301 and continue to be treated with a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs). Patients who previously received Nefecon in Study Nef-301 will receive retreatment, whereas patients who previously received placebo in Study Nef-301 will be treatment naïve to Nefecon.

This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in patients with IgAN who have completed the Phase 3 Study Nef 301 and continue to be treated with a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs). Patients who previously received Nefecon in Study Nef-301 will receive retreatment, whereas patients who previously received placebo in Study Nef-301 will be treatment naïve to Nefecon. During Study Nef-301 OLE, the patients and Investigators will remain blinded to treatment given in Study Nef-301.

During Study Nef-301 OLE, patients will receive Nefecon for a 9-month period. The dose may be reduced if clinically relevant adverse events (AEs) develop during the 9-month Treatment Period that the Investigator considers related to the study drug and that mandate dose reduction.

Patients will remain on a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) throughout the study. The patient will come for a follow-up visit at 12 months after first dose.

Eligibility Criteria:
Inclusion Criteria:

1. Patients that completed study Nef-301
2. On a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) at the maximum allowed dose or maximum tolerated dose according to the 2012 KDIGO guidelines
3. Willing and able to provide written informed consent.
4. UPCR equal to or more than 0.8 g/gram
5. eGFR equal to or more than 30 mL/min per 1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

Exclusion Criteria:

1. Systemic diseases that may cause mesangial IgA deposition.
2. Patients who have undergone a kidney transplant;
3. Patients with presence of other glomerulopathies and/or nephrotic syndrome
4. Patients with acute, chronic, or latent infectious disease including hepatitis, tuberculosis (TB), human immunodeficiency virus (HIV), and chronic urinary tract infections;
5. Patients with liver cirrhosis, as assessed by the Investigator;
6. Patients with a diagnosis of type 1 or type 2 diabetes mellitus which is poorly controlled
7. Patients with history of unstable angina, class III or IV congestive heart failure, and/or clinically significant arrhythmia, as judged by the Investigator;
8. Patients with unacceptable blood pressure control defined as a blood pressure consistently above national guidelines for proteinuric renal disease, as assessed by the Investigator.
9. Patients with diagnosed malignancy within the past 5 years.
Development and Validation of a Therapeutic Decision Aid in Ectopic Pregnancy: GEUDECID Study

The aim's study is to validate a therapeutic aid in women with a less active ectopic pregnancy. A prospective recrutement of 100 women will be performed in 16 different hospitals in France. The decision aid will be used and a questionnaire about its usefulness, comprehension and satisfaction will be given to women and doctors.

In less active ectopic pregnancy, two treatments are possible: a medical treatment using methotrexate or a surgical management.

A discret choice experiment study was performed to reveal women's preferences between these two options. In conclusion, calculated preferences are 47.5 and 52.5%, revealing a difficult choice for women. This study also lead to identify the main attributes important to make the choice. We were then able to create a therapeutic decision aid to help this shared decision.

This aid needs to be validated, following steps for validation. This study is the last step in women in situation of less active ectopic pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Women who speak and read french
* Not opposed to participate to the research
* With a tubal ectopic pregnancy visible at sonography
* with an HCG rate under 10 000UI/ml

Exclusion Criteria:

* Cardiac activity present in the embryo
* Hemoperitoin
* Hemodynamic instability
* Spontaneous pelvic pain
* Contre indication to methotrexate
* Protected adult patient
Documentation of Continuous Wheeze and Cough Dynamics in Pediatric ER SOB Patients

Phenotype characterization of shortness of breath of pediatric emergency room patients by objective wheeze and cough monitoring improves diagnostic and severity assessment accuracy and correlates with overall patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* patient is admitted to the ER with shortness of breath
* patient management is according to standardized protocols used in Hadassah Mt. Scopus pediatric emergency department including:

  * asthma management protocol
  * bronchiolitis management protocol
* ages 0 - 15
* patient's parent/guardian is able to comprehend and give informed consent for participating in the study

Exclusion Criteria:

* patient has received any dose of inhaled bronchodilators in the hour prior to enrollment
* patient has received oral or IV steroids in a time window of 30 minutes to 5 hours prior to enrollment
* ventilated patients, while ventilated
* chest skin lesions
* cystic fibrosis
* hemodynamic instability
* patient's parent/guardian objects to the study protocol
* concurrent participation in any other clinical study
* physician objection
O-SEMA-Fast: A Research Study to Understand How Oral Semaglutide Works in People With Type 2 Diabetes Who Plan to Fast During Ramadan in the United Arab Emirates, Saudi Arabia, and Kuwait

The purpose of the study is to look at the change in blood sugar levels in people with type 2 diabetes who are using oral semaglutide and planning to fast during Ramadan. Participants will take oral semaglutide as prescribed by the study doctor. The study will last for about 5 months (20 weeks). Participants will be asked to complete a patient diary about how and when they take the oral semaglutide tablets. Participants will complete this diary during the study period as instructed by study doctor.


Eligibility Criteria:
Inclusion Criteria:

1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
2. The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
3. Male or female, age above or equal to 18 years at the time of signing informed consent
4. Patients diagnosed with T2D who intend to fast during Ramadan
5. Patient should be on oral semaglutide (at least 4 weeks on maintenance dose) with or without other OADs
6. Available HbA1c value ≤ 30 days prior to the patient enrolment visit (V1) or HbA1c measurement taken in relation with the patient enrolment visit (V1) if in line with local clinical practice

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study
2. Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to the patient enrolment visit (V1) and throughout the duration of the study
3. Patients with type-1 diabetes and gestational diabetes
4. Patients who are pregnant or are planning to become pregnant during the conduct of the study
5. Patients who are breastfeeding
6. Patients on Insulin therapy within 2 weeks prior to enrolment
7. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Prospective Study on Polypectomy Complications: SPoC.

Colonoscopy has been shown to reduce both the colo-rectal cancer incidence and mortality, due to its capability to detect and remove precancerous lesions. However, polypectomy is associated with complications, such as bleeding and perforation, with an estimated overall incidence of about 10%, with polyp size and right-sided location considered as major risk factors. Aim of present study was to prospectively evaluate the early and delayed (30-days follow-up) complications of polypectomy in a multicenter regional Italian real practice setting


Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing endoscopic polypectomy

Exclusion Criteria:

* pregnancy
* incapacity to give informed consent
Blastocyst Euploidy Assessment and Conditioned embryO traNsfer

The study is designed to evaluate the effectiveness of pre-implantation genetic screening (PGS) for infertility patients of advanced maternal age undergoing assisted reproductive treatment. Half of the patients will have their embryos tested by PGS and 1 or 2 chromosomally normal embryos with the highest morphological grading transplanted back to the uterus. The other half of the participants will not have their embryos tested and 1 or 2 untested embryos with the highest morphological grading transplanted back to the uterus.

PGS is an assisted reproductive technology that screens patients embryos, discriminating between embryos with a normal set of chromosomes (euploid) and those with an abnormal set of chromosomes (aneuploid). In this study, we will apply a novel validated next generation sequencing technology called copy number variation sequencing (CNV-Seq) to comprehensively screen a trophectoderm biopsy sample from patient's embryos for chromosomal abnormalities that commonly arise in human embryos. The hypothesis is that PGS performed using CNV-Seq on embryos produced by patients with a poor prognosis for pregnancy (maternal age \> 35), followed by transfer of chromosomally normal euploid embryos, will result in significantly higher implantation, pregnancy and live birth rates and lower miscarriage rates compared to patients having no PGS.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing in vitro fertilization (IVF)
* Normal uterine function by ultrasound and absence of hysteromyoma
* Regular menstrual cycle of 25-35 days
* Normal hormone levels (WHO standard) for LH, PRL, E2, PROG, TEST and TSH
* FSH 1-12 IU/L and follicle number \> 5 on day 2-3 of menstrual cycle
* Minimum of 3 blastocysts on day 5 of embryo development
* Signed consent form

Exclusion Criteria:

* Known endometriosis
* Abnormal vaginal bleeding with no known cause
* Known genital organ system malformation, unsuitable to conceive
* Known currently active pelvic inflammation
* Abnormal liver, kidney lab results, with clinical implications.
* Known endocrine or metabolic disorders (pituitary gland, adrenal glands, pancreas, liver or kidney）
* Known ovarian, breast, uterine, adrenal glands, pituitary gland or hypothalamus tumor
* Known abnormal cervical cancer lesions, with clinical implications, within one year before PGS
* History of chemo- or radio-therapy
* Seropositive for HIV, Hep B, Hep C or TPPA/RPR (Syphilis)
* Known ovarian poor response in previous cycles, i.e. after administration of GnRH for \> 20 days
* More than 2 implantation failures
* More than 2 miscarriages
* Known altered parental karyotype such as Robertsonian or reciprocal translocation
* Use of sperm or oocyte donors
* Severe male factor (surgical retrieval of sperm)
* Preimplantation genetic diagnosis cycles for single gene diseases or sex selection
* Participation in other IVF research studies
* Patient refusal or inability to follow the protocol for any good reason, including clinical visit or lab test