cyrilzakka/clinical-trials huggingface dataset:
Study of Efficacy and Safety of Twice Daily Oral Iptacopan (LNP023) in Adult PNH Patients Who Are Naive to Complement Inhibitor Therapy

The purpose of this Phase 3 study was to determine whether iptacopan is efficacious and safe for the treatment of Paroxysmal nocturnal hemoglobinuria (PNH) patients who were naïve to complement inhibitor therapy.

This study was a multicenter, single-arm, open-label trial which was comprised of 8 weeks screening period, 24-week core treatment period and 24-week extension treatment period.

Eligible PNH patients with hemolysis (LDH \> 1.5 ULN) and anemia (hemoglobin \<10 g/dL), who were naive to complement inhibitor therapy, including anti-C5 antibody treatment, received iptacopan monotherapy at a dose 200 mg orally b.i.d.

Eligibility Criteria:
Inclusion Criteria:

* Male and female participants ≥ 18 years of age with a diagnosis of PNH confirmed by high-sensitivity flow cytometry with RBCs and WBCs clone size ≥ 10%
* Mean hemoglobin level \<10 g/dL
* LDH \> 1.5 x Upper Limit of Normal (ULN)
* Vaccination against Neisseria meningitidis infection is required prior to the start of study treatment
* If not received previously, vaccination against Streptococcus pneumoniae and Haemophilus influenzae infections should be given

Exclusion Criteria:

* Prior treatment with a complement inhibitor, including anti-C5 antibody
* Known or suspected hereditary complement deficiency
* History of hematopoietic stem cell transplantation
* Patients with laboratory evidence of bone marrow failure (reticulocytes \<100x109/L; platelets \<30x109/L; neutrophils \<0.5x109/L).
* Active systemic bacterial, viral (incl. COVID-19)or fungal infection within 14 days prior to study drug administration.
* History of recurrent invasive infections caused by encapsulated organisms, e.g. meningococcus or pneumococcus.
* Major concurrent comorbidities including but not limited to severe kidney disease (e.g., dialysis), advanced cardiac disease (e.g., NYHA class IV heart failure), severe pulmonary disease (e.g., severe pulmonary hypertension (WHO class IV)), or hepatic disease (e.g., active hepatitis) that in the opinion of the investigator precludes participant's participation in the study.
Prevalence, Etiology and Effects on Oral Health and Life Quality of Molar Incisor Hypomineralization

Molar incisor hypomineralization (MIH) can lead to many clinical conditions and affect oral health-related quality of life (OHRQoL).

Molar incisor hypomineralization (MIH) can lead to many clinical conditions and affect oral health-related quality of life (OHRQoL). The aim of this study was to determine the prevalence, etiology and impacts of MIH on oral health status and OHRQoL.

Six hundred and fifty-five parents and their children aged 9 years were included in the study. After parents completed the questionnaire about the etiology of MIH, children's OHRQoL was measured by the Child Perceptions Questionnaire (CPQ8-10). Children were evaluated for presence and severity of MIH, dental caries experience and oral hygiene status. Qualitative data were analyzed with the Pearson chi-square and Fisher's exact tests. For the quantitative data, if the normal distribution was not satisfied, Kruskal Wallis/Mann-Whitney U tests were used. Also, Binominal logistic regression analysis was performed and p\<0.05 was statistical significant.

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Eligibility Criteria:
Inclusion Criteria:

* Being 9-year-old,
* Mentally and physically capable of completing the questionnaire,
* Presence of fully erupted 4 permanent molars and 8 permanent incisors.

Exclusion Criteria:

* Children were receiving orthodontic treatment during the examination,
* Children had enamel hypoplasia or developmental defects,
* Children had amelogenesis imperfecta or dental fluorosis.
Antiresorptive Effects of a 6-m Treatment Course With Ibandronate Plus Supplementation of Vitamine D and Calcium in Central America

Ibandronate is a third-generation biphosphonate with recognized antiresorptive efficacy by several international, randomized, double-blind, controlled trials. These studies have not included patients from central america, to the best of our knowledge. Therefore, this open-label, uncontrolled study, was set out to assess the clinical effects of a 6-m treatment course with Ibandronate plus vitamine D and Calcium on bone mineral density and health-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Women with a diagnosis of osteoporosis of at-Risk
* Have a medical indication to receive Ibandronate+Vitamine D+Calcium

Exclusion Criteria:

* Osteoporosis due to secondary causes
Use of a Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus

Crosslinking is a therapeutic technique used to increase the rigidity of the cornea in order to slow or stop progression of keratoconus. The main complication of the treatment of keratoconus by crosslinking is postoperative pain due to the removal of the corneal epithelium. Currently, the management of pain is done through the administration of artificial tears and paracetamol. The amniotic membrane is a biological tissue used in ophthalmology to treat injuries of the surface of the eye. It has healing and analgesic properties.

The objective of this multicenter randomized study is to evaluate the benefit of placing an amniotic membrane on the eye post-crosslinking to reduce pain and promote corneal healing.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman between 18 and 65 years old.
* Indication for accelerated conventional crosslinking.
* Patient with progressive keratoconus (increase in Kmax of ≥ 0.5 diopters in 3 to 6 months or ≥ 1 diopter in 3 to 12 months with loss of 10 microns on minimum pachymetry in 3 to 12 month).
* Patient suffering from keratoconus with a compatible topographic form (Kmax ≥ 47.0 diopters (D) and difference inferior-superior of 1.5 D).
* Patient with a minimum corneal thickness greater than 400 microns.
* Informed and consenting patient.
* Patient physically and mentally capable of completing the post-operative pain assessment self-questionnaire.
* Patient having signed the informed consent of the French Ophthalmology Society for crosslinking.
* Patient affiliated to a social security system or beneficiary of such a system.

Exclusion Criteria:

* Woman without effective means of contraception, pregnant or breastfeeding.
* Patient who has already benefited from a crosslinking procedure on one of the eyes.
* Patient with a history of refractive surgery on one of the eyes.
* Patient with an intracorneal ring segment on one of the eyes.
* Patient suffering from a serious systemic pathology (autoimmune and/or immunodepressive)
* Patient with a psychiatric pathology.
* Patient on long-term analgesics and/or corticosteroids.
* Indication of crosslinking outside the classic protocol.
* Patient with central corneal opacity.
* Patient suffering from a severe dry eye syndrome or a neurotrophic keratitis.
* Patient with a history of ocular herpes.
* Patient with a history of ocular varicella-zoster virus infection.
* Patient with glaucoma.
* Patient treated with topical cyclosporine in the last 6 months.
* Patient deprived of liberty by a judicial or administrative decision.
* Patient subject to a legal protection measure or unable to express their consent.
Release of Nociceptin From Granulocytes in Sepsis

Nociceptin is a protein found in the body, with a number of functions in the central nervous system, blood vessels and the gut. There is evidence that it may have a role in controlling the immune response to infection, and may act as a link between the brain and immune system.

In infection, or after surgery, there is an increase in nociceptin, and subjects greater elevations of nociceptin have a poorer outcome. There is evidence that cells of the immune system may produce nociceptin, although it is not yet known which cells are capable of producing it, and what "switches on" production.

This study aims to determine

1. Which cells of the immune system can produce nociceptin
2. If there is a difference in the ability to produce nociceptin between healthy volunteers and patients with severe infections


Eligibility Criteria:
Inclusion Criteria:

* For septic patients;

  1. Participant is willing and able to give informed consent for participation in the study, or if lacking capacity, a next of kin or advocate is willing and able to give assent for participation in the study. Must be able to read and understand English.
  2. Male or Female, aged 18 years or above.
  3. Diagnosed with sepsis and admitted to the intensive care unit.
  4. Able (in the Investigators opinion) and willing to comply with all study requirements.
  5. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

Healthy Volunteers;

1. Participant is willing and able to give informed consent for participation in the study. Must be able to read and understand English.
2. Male or Female, aged 18 years or above and be
3. In good health.
4. Have had no course of medication, whether prescribed or over-the-counter, in the four weeks before first study dose and no individual doses in the final two weeks other than mild analgesia, vitamins and mineral supplements or, for females, oral contraceptives
5. Able (in the Investigators opinion) and willing to comply with all study requirements.
6. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

Exclusion Criteria:

* 1. Conditions which may make phlebotomy hazardous to the participant (such as significant bleeding disorders or anaemia, or allergy), or to the investigator (blood viral infection).

  2. Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

  3. Participants who have participated in another research study involving an investigational product in the past 12 weeks.
A Comparison Between Glargine and Detemir Insulin in Type 2 Diabetes

The purpose of this study that when studies using our method of dosing adjustments driven by continuous glucose monitoring and because of the less variable glycemic effect of insulin detemir, insulin detemir treated subjects will spend a significantly greater time in the glucose target range than insulin glargine.

Todate, most studies have compared insulin detemir and glargine to NPH and not to each other. Depending of their design, these studies have shown both insulins lower the fasting glucose, A1c, the incidence of hypoglycemia and are associated with less weight gain than NPH. In the only direct comparison study of these two basal insulins, insulin detemir demonstrated significantly less day to day variation than glargine as measured by glucose infusion rated during an euglycemic clamp study. Given the same incidence of hypoglycemia, this last study would suggest that insulin detemir treatment could achieve target glucose control more than glargine. We have used continuous glucose monitoring (CGMS) extensively in our practice. CGMS is arguably the most sensitive method for detecting differences in glycemic control in the outpatient setting and there by allowing fine adjustments in insulin treatment. When comparing insulin glargine to preprogrammable basal insulin as delivered by continuous subcutaneous infusion and using CGMS, we have shown significantly better glucose control with continuous subcutaneous infusion, We have also developed a method of daily insulin dosage adjustments during a continuous CGMS study from daily glucose tracings downloaded. This allows for an even more accurate basal insulin replacement per set glycemic goal. This protocol addresses a comparison of insulin glargine and insulin detemir for patients evaluated by CGMS.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes
* Currently on a basal insulin, that is, NPH, glargine or detemir
* Capable of self monitoring glucose \>4/day
* Previously complaint with clinical recommendations
* Subject may be on oral antiglycemic medications but no change in treatment is permitted during study.

Exclusion Criteria:

* Hb A1c \>9.0%
* Urinary ketosis
* Currently or expected alteration in insulin sensitivity such as major surgery, infection, renal failure (creatine \>1.5 mg/dL) glucocorticoid treatment, recent (within 2 weeks) serious hypoglycaemic episode (requires assistance of another)
* Currently participating in another clinical trial
* Known or suspected allergy to insulin glargine or detemir
* Using other insulins, such as, bolus insulin or premixed insulin
* Sight or hearing impaired
* Pregnancy oor nursing of the intention of becoming pregnant or not using adequate contraceptive measures.
Contrast-Enhanced Digital Mammography (CEDM) for Identifying a Change in Management of Women With Newly Diagnosed Breast Cancer

Enrolled women will undergo a bilateral Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) as per usual clinical practice within 30 days of breast cancer diagnosis. Up to 8 weeks after the CE-BMRI exam, subjects will undergo a Dual Energy Contrast Enhanced Digital Mammograph (DE-CEDM).

Enrolled women will undergo a bilateral Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) as per usual clinical practice within 30 days of breast cancer diagnosis. Up to 8 weeks after the CE-BMRI exam, subjects will undergo a Dual Energy Contrast Enhanced Digital Mammograph (DE-CEDM). Maximum lesion size was compared between the two imaging types. Subject data from both scans was planned to be included in a multi-reader evaluation; however, due to premature stop of the study, multi-reader data was not collected.

Eligibility Criteria:
Inclusion Criteria:

* Woman 21 years of age or older
* The subject is able and willing to comply with study procedures and signed and dated informed consent is obtained.
* Newly diagnosed with Breast Cancer (DCIS or invasive) identified through core biopsy or fine-needle aspiration (FNA) within last 30 days.
* Will have or have had a bilateral CE-BMRI performed within 30 days AFTER the new breast cancer diagnosis.

Exclusion Criteria:

* Woman who has already had a lumpectomy for the index lesion.
* Woman undergoing neoadjuvant chemotherapy treatment, hormone treatment or radiation therapy.
* Woman who is pregnant or who believe she may be pregnant.
* Woman who has breast implant.
* Woman who has a contraindication to the intravenous use of iodinated or gadolinium-chelated contrast agent (e.g., allergy to either agent or severely impaired renal function).
Sphenopalatine Ganglion Block to Treat Shoulder Pain During and/or After Cesarean

The purpose of this open label pilot study is to evaluate the utility of sphenopalatine ganglion (SPG) block to manage ipsilateral shoulder pain (ISP) during and/or after cesarean.

Shoulder pain thought to be caused by blood and amniotic fluid irritation of the diaphragm and nerves that supply the shoulder, can occur during and/or after a cesarean. Investigators will consent 100 patients, and will enroll 10 patients who develop ISP and have a score of is \>5/10 on the Verbal Analog pain Scale (VAS). Patients will be their own controls. Transnasal SPG block will be performed after childbirth, and and beginning at 20 minutes post treatment, the patient will be asked to rate their shoulder pain using the VAS a number of times.

Eligibility Criteria:
Inclusion Criteria:

* Cesarean
* Presence of post-operative ISP, VAS \>5/10
* American Society of Anesthesiologists Class 1 - 3.
* No allergy to lidocaine

Exclusion Criteria:

* American Society of Anesthesiologists Class 4 or 5.
* Allergy to lidocaine
* Nasal pathology (e.g., deviated septum)
* Patients who receive sedatives during cesarean
* Bleeding diathesis
* Any patient who the PI feels will be unable to comply with all protocol related procedures
* Shoulder pain prior to cesarean
Tacrolimus Versus Prednisolone for the Treatment of Minimal Change Disease

The purpose of this study is to compare the effectiveness of tacrolimus (prograf) versus prednisolone for the treatment of nephrotic syndrome secondary to minimal change disease.

Minimal change disease is a common cause of nephrotic syndrome in adults. Standard treatment is with high dose steroids which is often effective in controlling the nephrotic syndrome but has a high morbidity due to the side effects of the steroids. There is also a high relapse rate,therefore many patients require long term steroid therapy to control their disease which has significant morbidity and mortality. Some patients are or also become steroid resistant. There are studies showing the effectiveness of alkylating agents such as cyclophosphamide but the use of these drugs is limited by their toxicity, including increased rates of infection, cancers and infertility.

Tacrolimus (prograf) is a T-cell specific calcineurin inhibitor that shares similar immunosuppressive actions with cyclosporine A.In other glomerular diseases such as focal segmental glomerulosclerosis and membranous glomerulonephritis, prograf has been shown to be a very effective treatment for proteinuria. This may be due to the immunomodulatory effects on the underlying disease, but there may also be a direct effect of tacrolimus (prograf) on the podocyte, stabilising the actin cytoskeleton and therefore decreasing protein leak.Therefore tacrolimus (prograf) is likely to be effective in reducing proteinuria in minimal change disease.It has also been shown to have a good side effect profile when used to allow the avoidance of steroids in transplantation.This study aims to prospectively study if tacrolimus (prograf) is effective as treatment for minimal change disease compared with standard therapy with steroids, and whether it has advantages in terms of side effect profile and prevention of relapse.

Eligibility Criteria:
Inclusion Criteria:

* Patients with nephrotic syndrome (hypoalbuminaemia and protein creatinine ratio (PCR) \> 100units), secondary to minimal change disease.
* Age over 18.

Exclusion Criteria:

* Hepatitis B, hepatitis C or HIV infection.
* Untreated infection.
* Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception.
* Patients who have been treated with immunosuppression over the last 18 months.
* Patients who have had more than 3 relapses of nephrotic syndrome within 5 years.
* Any condition judged by the investigator that would cause the study to be detrimental to the patient.
Comparison Between Uterine Artery Doppler and Placental Vascular Indices in Prediction of Preeclampsia

• Preeclampsia is a multisystem disorder that can cause considerable maternal and fetal morbidity and mortality. Late preeclampsia (with delivery \>34 weeks) is more frequent and less serious than early preeclampsia (with delivery \<34 weeks). Poor early placentation has been especially associated with early disease. Early identification of women at risk of preeclampsia is currently a crucial aim of antenatal care since they may benefit from prophylactic treatment and increased surveillance.

* The introduction of three-dimensional (3D) ultrasound techniques, with the option of calculating placental volume and measuring vascular indices, has created an excellent opportunity to study early changes in the uteroplacental circulation space, which includes the maternal spiral arteries and the intervillous space. This technology may allow a more direct evaluation of the abnormal placentation process thought to herald the development of preeclampsia.
* The aim of this study was to assess the usefulness of placental volume and 3D vascular indices as reliable predictors of early preeclampsia in comparison to uterine artery Doppler

Eligibility Criteria:
Inclusion Criteria:

* A. Control group: Pregnant women:

  1. Age between 18-35 years
  2. Parity: primigravidas and multiparas.
  3. Have no history of preeclampsia or eclampsia.
  4. Have no history of chronic hypertension.
  5. Not diabetic.
  6. Not have antiphospholipid syndrome.
  7. Not have autoimmune disease such as SLE.

B. High risk group: Pregnant women with:

1. History of preeclampsia -Eclapmsia
2. Chronic hypertension
3. Diabetic
4. Antiphospholipid syndrome.
5. Autoimmune syndrome such as SLE.

Exclusion Criteria:

* • Smoking

  * Dichorionic placentae
  * Fetal anomaly
  * Uterine fibroid at the site of placental implantation
  * Subchorionic hematoma
Prenatal Corticosteroids and Antioxidants in Preterm Infants

Premature infants are highly susceptible to oxidative stress because of the immaturity of their antioxidant defense system. The use of prenatal glucocorticosteroids administered to the mother improves respiratory function and overall outcome. The investigators hypothesize that prenatal glucocorticosteroids favor the expression and competence of the antioxidant defense system.

This is an observational study recruiting extremely low gestational age neonates (\<28 weeks gestation) whose mothers received or not full scheduled prenatal glucocorticosteroids. Healthy term newly born infants acted as controls.

At birth cord blood were drawn for the following analytical determinations: reduced and oxidized glutathione; malondialdehyde; superoxide dismutase; catalase; glutathione peroxidase; glutathione reductase; glutathione s-transferase. In addition, first urine voided was collected for ortho-tyrosine/phenylalanine and 8-hydroxy-2-oxo-deoxyguanosine/2-deoxyguanosine determination. Analytical data and clinical outcomes are compared.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age \<28 weeks
* Registered used or not of prenatal glucocorticosteroids by the mother

Exclusion Criteria:

* Use of pro-or-antioxidant drugs by the mother during gestation
* Major congenital malformations
* Prenatal inflammation (E.G.:chorioamnionitis)
* Chromosomopathies
* Uncertainty about gestational age
Effects Of Single Doses Of GW784568X On Allergic Rhinitis Symptoms In Male Subjects Whilst In An Environmental Chamber

This study was designed to look at safety aspects and effects of intranasal doses of GW784568X on allergic rhinitis symptoms to develop this drug for its use in people who suffer with allergic rhinitis

A randomised, placebo-controlled, 4-period, incomplete block, crossover study of 7 days dosing of intranasal GW784568X (100mcg, 200mcg and 400mcg od), fluticasone propionate (200mcg od) and placebo (blinded for GW784568X vs placebo) to evaluate the efficacy and safety using an environmental chamber in male subjects with allergic rhinitis

Eligibility Criteria:
Inclusion criteria:

* Healthy with exception of seasonal rhinitis. May also have mild asthma.
* Weight greater than or equal to 50kg
* Non-smoker for at least 12 months

Exclusion criteria:

* History of frequent nosebleeds
* Have participated in another trial in the last 30 days.
* Have donated blood in the previous 3 months
* Have used prescription or non prescription drugs within last 7 days
* Have history of alcohol/drug abuse within last 12 months
* Have positive Hepatitis B or C test within 3 months of screening
* Subject tested positive for HIV