cyrilzakka/clinical-trials huggingface dataset:
Long-term, Safety, Tolerability and Efficacy Study of AFQ056 in Adult Patients With Fragile X Syndrome

The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in eligible adult patients with FXS who have participated in the CAFQ056A2212 (NCT01253629).study and patients who have participated in the previous proof-of-concept study CAFQ056A2204 (NCT00718341).

A 148 patients were enrolled into this treatment extension trial conducted for at least 3 years. This extension trial was terminated after the decision to terminate the AFQ056 development program. The decision was based on the results of two randomized, double blind, placebo controlled phase IIb trials in adult and adolescent FXS patients (CAFQ056A2212 and CAFQ056B2214respectivly), both of which failed to demonstrate efficacy in the FXS population. As this extension trial was terminated, only the primary objective and safety are represented.

Eligibility Criteria:
Inclusion criteria Group 1 patients

* Had to have completed the CAFQ056A2212 study or another study of AFQ056 which included adult FXS patients within one week of enrollment into the open-label study.
* Females of child-bearing potential had to follow protocol requirements with respect to contraception.
* Have a caregiver or caregivers who spent, on average, at least six hours per day with the patient, who were willing and capable of supervising treatment, providing input into efficacy and safety assessments, and accompanying the patient to study visits.

Group 2:

* Had to have:
* Completed Study CAFQ056A2204.
* Completed Study CAFQ056A2212 or another study of AFQ056 which included adult patients with FXS but enrollment into the current study was delayed for more than a week.
* Discontinued prematurely from Study CAFQ056A2212 or another study of AFQ056 which included adult patients with FXS due to intolerability of the dosage in the patient's assigned treatment group.
* Females of child-bearing potential had to follow protocol requirements with respect to contraception.
* Have a caregiver or caregivers who spent, on average, at least six hours per day with the patient, who were willing and capable of supervising treatment, providing input into efficacy and safety assessments, and accompanying the patient to study visits

Exclusion criteria

Any advanced, severe or unstable disease

* History of severe self- injurious behavior
* History of uncontrolled seizure disorder or resistant to therapy within the past 2 years (Patients who are clinically stable under anti-convulsant therapy for the past 2 years are not excluded)
* History of clinically significant allergies requiring hospitalization or non- inhaled corticosteroid therapy (asthma, anaphylaxis, etc.)
* Using (or used within 6 weeks before baseline) concomitant medications that are potent inhibitors or inducers of CYP3A4
* Using glutamatergic agents (riluzole, memantine, etc.) or lithium, digoxin, or warfarin within 6 weeks of baseline Other protocol-defined inclusion/exclusion criteria may apply
Early Oral Feeding for Patients After Pancreaticoduodenectomy

This study intends to retrospectively analyze the patients who underwent pancreatoduodenectomy and compare the safety and feasibility between early enteral nutrition through nasojejunal tube and early oral feeding after pancreatoduodenectomy. This study is expected to revise the guidelines for early nutritional support after pancreaticoduodenectomy, reduce postoperative complications, and provide better guidance for clinical work.

Pancreaticoduodenectomy is the standard treatment for periampullary and pancreatic head carcinomas, with the high incidence of perioperative complications ranging from 40% to 60%. Malnutrition is a relevant predictor of post-operative morbidity and mortality after pancreatic surgery. Adequate nutrition is the key to reduce perioperative complications, including abdominal infection, poor healing of wounds, and even gastrointestinal anastomotic leak. The optimal nutritional support method after Pancreaticoduodenectomy is still uncertain, and the current nutritional support methods are diverse. The results of an international survey showed that there was very poor or no agreement on postoperative strategies for the management of nutrition after Pancreaticoduodenectomy. Therefore, the investigators designed this retrospective study to evaluate which was safer and more feasible between early oral feeding and nasojejunal early enteral nutrition after Pancreaticoduodenectomy, using the method of propensity score weighting.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent pancreaticoduodenectomy by a certain surgeon in Changhai Hospital
* Patients who were treated with nasojejunal enteral nutrition or oral enteral nutrition after operation.

Exclusion Criteria:

* Patients who underwent pancreaticoduodenectomy by other surgeons during the same period;
* Patients who received other nutritional support rather than nasojejunal tube enteral nutrition or oral enteral nutrition after operation.
Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Nail Psoriasis

This purpose of this study was to demonstrate the efficacy of secukinumab versus placebo on nail psoriasis and to assess long-term efficacy, safety and tolerability of secukinumab.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with chronic moderate to severe plaque type psoriasis for at least 6 months prior to randomization, including significant nail involvement, defined as Nail Psoriasis Severity Index (NAPSI) score ≥16 AND number of fingernails involved ≥4 AND Psoriasis Area and Severity Index (PASI) score ≥12 AND Body Surface Area (BSA) score ≥10%
* Candidates for systemic therapy, i.e. psoriasis inadequately controlled by topical treatment (including super potent topical corticosteroids) and/or phototherapy and/or previous systemic therapy

Exclusion Criteria:

* Forms of psoriasis other than chronic plaque type psoriasis (e.g., pustular psoriasis, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic and guttate psoriasis)
* Drug-induced psoriasis (e.g. new onset or current exacerbation from β-blockers, calcium channel inhibitors or lithium)
* Ongoing inflammatory skin diseases other than psoriasis or any other disease affecting the fingernails which may potentially confound the evaluation of study treatment effects
* Ongoing use of prohibited treatments (e.g. topical or systemic corticosteroids (CS), UV therapy). Washout periods do apply
* Prior exposure to secukinumab (AIN457) or any other biological drug directly targeting IL-17 or the IL-17 receptor
* Exposure to any investigational drugs within 4 weeks prior to study treatment initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer
* History of hypersensitivity to constituents of the study treatment
* Other protocol-defined inclusion/exclusion criteria do apply
Gonadotropin-Releasing Hormone (GnRH)-Antagonist Therapy in Rheumatoid Arthritis

The purpose of this study is to compare the safety and efficacy of gonadotropin-releasing hormone (GnRH) antagonist therapy versus placebo in patients with moderate to severe rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Adult between 18 years and above
* Moderate to severe disease activity
* Negative pregnancy test for women of childbearing potential
* Use of reliable method of contraception (non-hormonal) by sexually active female patients

Exclusion Criteria:

* Patients who are pregnant or breastfeeding
* Patients taking biologic therapy or prednisolone \>7.5mg
Psychomotor Therapy for Very Premature Infants

Our current reflexion is that sensory dys-stimulations, including vestibule-proprioceptive disorders and unbalanced between brain and brainstem maturation of the neonatal period involve an early deviant development for immature infants that will be cascaded through the brain scaffolding and later development. The primary purpose is to determine whether the Early Psychomotor Therapy Intervention Program improves development and behavior in very preterm infants (VPI) at 24-month corrected age (CA).

VPI \< 30 week of amenorrhea were randomized, in a simple blind controlled trial. The psychomotor development was evaluated according to the Bayley Scales of Infant Development-III (BSID-III) at 2 years CA. An intermediate point was provided at 9 months CA. Pediatric standardized assessments and psychologist semi-directive interviews were conducted. Parents also completed a self-administering questionnaire relating to the post-traumatic stress. The intervention consisted on 20 therapy sessions between 2 and 9 months CA, in order to support infants' development, and parent-infant interactions and adjustment.

Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Infants with a gestational age between 24 and 30 weeks.

Exclusion Criteria:

* Infants with congenital disease,
* Infants with brain bleeding grade III-IV,
* Infants with periventricular leucomalacia,
* Infants whose mothers had a documented history of physical or mental illness, or drug abuse
* Infants from non-French -speaking families.
StO2 Performance Measured on Admission to the Emergency Department in the Assessment of Drug Poisoning

The primary purpose of the protocol is to evaluate the StO2 performance measured at the admission to the emergency department to identify hemodynamic failure at the admission or within the first three hours of monitoring patients with drug poisoning.

The study hypotheses are:

* The early detection of hypoperfusion by StO2, essential to prevent the development of collapse.
* To limit hemodynamic failure effects, reduce morbidity and mortality of drug poisoning, hospital stay and cost.

The procedure is a measurement and non-invasive monitoring system of percentage of oxygen saturation of haemoglobin in tissues using infrared technology. The system used in the study is the tissue oxygenation monitor InSpectraTM StO2 Spot Check, Model 300 consisting of a clamp applied to the base of the thumb of the patient.

Eligibility Criteria:
Inclusion Criteria:

* admitted to the emergency department,
* whose pattern of hospitalization is drug poisoning, defined on data from the patient's interrogation or his family if the patient is not able to answer,
* Written informed consent signed by the patient or, if he's unable to sign, by a companion,
* Affiliated to medical insurance

Exclusion Criteria:

* Patients without thenar eminence or having a disease of the thenar,
* Refusal to participate in the study,
* Participation in another biomedical research,
* Patient under guardianship, trusteeship or judicial protection,
* Pregnant women or nursing mothers
Effect of Human Papillomavirus Self-Collection on Cervical Cancer Screening in High Risk Women: My Body, My Test 3

This study will investigate whether cervical cancer screening completion among under-screened women could be improved by offering HPV (human papillomavirus) testing by at-home self-collection followed by screening invitation compared to screening invitation alone.

Invasive cervical cancer (ICC) is preventable through regular screening and treatment, but one fifth of US women report not receiving Pap testing at recommended intervals. More than half of ICC cases occur in these under-screened women. For women 30 years and older, the US Preventive Services Task Force recommends Pap smears alone every 3 years or physician-collected HPV testing with Pap smear (co-testing) every 5 years. The FDA approved primary HPV physician screening for US women 25 years and older. Self-collection for HPV testing is a valid and well-accepted method for detecting HPV infection with comparable sensitivity and specificity to physician-collection for detecting high-grade cervical lesions.

This 2-arm randomized control trial of 510 women will investigate whether offering HPV testing by mailed at-home self-collection to under-screened women increases their likelihood of completing cervical cancer screening. All participants will received a screening invitation by phone: a phone call providing (i) education on cervical cancer, and (ii) assistance scheduling an appointment for free screening at a study-affiliated clinic, if needed. Those randomized to the intervention arm will first be mailed a kit to self-collect a cervico-vaginal sample, return the sample for oncogenic HPV testing, and receive their results by phone. HPV negative women will be considered screening complete. HPV positive women will be invited to schedule an appointment for free follow-up in-clinic screening in the same call in which their results are delivered. The study endpoint of screening completion will be defined as completing in-clinic screening (control arm participants and HPV positive intervention arm participants) or receiving a negative HPV self-collection result (intervention arm).

Aim 1. Determine whether at-home HPV self-collection increases completion of cervical cancer screening among under-screened women offered enhanced reminders.

Aim 2. Examine possible mechanisms explaining the intervention's effect, or lack of an effect.

Aim 3. Estimate the incremental cost per additional woman completing screening of adding at-home HPV self-collection to enhanced reminders.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged 25 to 64 years old
* Living at ≤250% of the federal poverty line
* Eligible to receive cervical cancer screening from a study-associated clinic
* Resides within the same or bordering county of a study-associated clinic

Exclusion Criteria:

* Completion of cervical Pap screening in preceding 4 years
* Completion of HPV testing in preceding 6 years
* Pregnant
* History of hysterectomy
* Private insurance
* Unable to provide informed consent
Paricalcitol Oral Therapy in Predialysis CKD Patients. The Greek Experience

The purpose of this study is to obtain data on the use of Zemplar (paricalcitol) capsules in real-life clinical practice in predialysis patients with chronic kidney disease (CKD) and secondary hyperparathyroidism.

This was a single arm, open, multicenter, non-interventional, post marketing observational study, which has been conducted in 24 sites in Greece, under normal clinical practice and as per the locally approved Summary of Product Characteristics (SmPC) of study medication (oral paricalcitol). Eligible patients were followed up for a 12-month period after enrollment. All study activities were consistent with European Union (EU) directive 2001/20/EC section for non-interventional studies.

In this study, paricalcitol was prescribed on an on-label basis in an everyday setting to observe drug actions in a distinct geography (Greece with \> 250 days/year of sunny days) as well as in a significant subpopulation (Chronic Kidney Disease \[CKD\] stages 3-5 transplanted patients). Dose tolerability, treatment effects, as well as maintenance of results were registered for a 12-month period in order to obtain experience in the long term use of paricalcitol capsules. Furthermore, in centers where additional blood parameters were examined as part of clinical routine, these were recorded and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with secondary hyperparathyroidism in the presence of chronic kidney disease stage 3, 4 or 5 treated with Zemplar (paricalcitol) oral for at least 1 month prior to study enrollment
* Male and female (not pregnant or not planning to be pregnant in the next 12 months) patients \> 18 years of age
* Signed informed consent by subject
* Hypertensive and diabetic subjects must be on an optimal and steady medication regimen for more than 30 days

Exclusion Criteria:

* Contraindications listed in the Summary of Product Characteristics for Zemplar capsules apply (Appendix I and II)
* Parathormone value of \> 1000 pg/mL (sign of tertiary hyperparathyroidism)
* Treatment with Vitamin D within the last 1 month prior to inclusion into the study
FreeStyle Libre- Effect on QOL in Type 2 Diabetes Patients

This is a randomized controlled study in type 2 diabetic patients who are presently uncontrolled on at least 2 injections of insulin daily with an A1C \>7.5 % and \<10%. Patients need to be stabilized on their MDI for 1 week then randomized to either SBGM or FreeStyle Libre for 10 weeks.

FreeStyle Libre Flash Glucose Monitoring System is an interstitial glucose monitoring system intended to be replacement for the capillary blood glucose measurement. The system contains several features that distinguish it from exiting sensor technology including no user calibration during 14 days of wear. The sensor is applied to the upper arm of the patient and the hand-held reader is used to scan the sensor to receive glucose result along with historic results with a 15 min frequency for up to 8 hours.

An AGP (=Ambulatory Glucose Profile) report is a way to present the glucose data collected by the time of day that has several advantages: demonstrates median glucose levels and the 25-75%, 10-90% excursions as well as the tendency for hypo or hyperglycemia throughout the day. This integration of results gives a more complete picture of the glucose control throughout the week/s while eliminating the "noise" from outliers.

The hypothesis is that the addition of FreeStyle Libre system for 10 weeks to the treatment of uncontrolled Type 2 diabetic patients currently on MDI, will produce a modification of behavior/life style and improvement in treatment satisfaction, quality of life and glycemic control and reduce the number of any/major hypoglycemia events.

Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes - more than 1 year
2. Age: 30 - 80 yrs
3. Treated with MDI: ≥ 2 injections daily
4. HbA1c: 7.5% to 10%
5. Willing to measure 7 daily blood tests at least one day each week
6. Willing to sign informed consent

Exclusion Criteria:

1. Type 1 diabetes
2. CV event within the last 6 months
3. Steroid therapy \> 7 days in last 6 months
4. Retinopathy - grade 3
5. Creatinine \>2 mg%
Investigation of DHA Intake in Pregnant and Lactating Women in China

This is a multi-center, cross-sectional, non-interventional, observational study--an investigation carried out in 816 pregnant (pregnant week 17±2 group and pregnant week 39±2 group; 408 cases in each group) and 408 lactating women (post-natal lactation day 42±7 group) from a total of 4 sites in 3 typical areas (1 coastal regions, 2 inland regions and 1 lake regions) in China to study the correlation between DHA intake and DHA concentrations in blood and breast milk.

This is a multi-center, cross-sectional, non-interventional, observational study in 816 pregnant (gestation week 17±2 group and gestation week 39±2 group 408 cases in each group) and 408 lactating women (post-natal lactation day 42±7 group) from a total of 4 sites in 3 typical areas (1 coastal regions, 2 inland regions and 1 lake regions) in China to study the correlation between DHA intake and DHA concentrations in blood and breast milk. Investigators are mainly physicians majoring in gynaecology and obstetrics, etc. During visits, the study physician will record the patient's social demographic data, disease and relevant medication history, review her medical records, assess DHA intake by the DHA Screener, and determine DHA concentrations in erythrocyte membrane, plasma and breast milk, so as to validate the feasibility of DHA Screener as DHA intake assessment tool for determining DHA concentrations in the body.

Subjects meeting inclusion criteria and non of the exclusion criteria will be informed of relevant information of the study. Subjects should be voluntarily consent to participate in the study and sign the informed consent form.

Screening of the study is scheduled for as long as 5 months. In this study, additional examinations or other interventions are not required.

Eligibility Criteria:
Inclusion Criteria:

PREGNANT WOMEN:

* Healthy women presenting at their week 17±2 and week 39±2 obstetric examination;
* 18-40 years of age;
* Monocyesis;
* Having signed the informed consent form voluntarity before participating in the study.

LACTATING WOMEN:

* Healthy women presenting at their day 42±7 post-natal visit;
* 18-40 years of age;
* Monocyesis;
* Having signed the informed consent form voluntarily before participating in the study

Exclusion Criteria:

* Administration of DHA supplements (milk powder for pregnant women, DHA soft capsule, Zmarto, NURIZ, Naturies, HeadDHA, Beibeicong, Nutrimed etc);
* Still experiencing severe vomiting after 16 weeks of pregnancy;
* Women who have heart, liver, kidney, (ALT and AST≥ 1.5 times of normal upper limit, Cr\>normal upper limit) or severe lung disease or laboratory abnormality (i.e.lipid metabolism disorder) that may interfere with the interpretation of study results, as indicated in previous examinations;
* Pregnant woman currently participating in other clinical trials or who have participated in another clinical trial in the last 30 days;
* Women who in the judgement of the investigator cannot be expected to comply with the protocol or study procedures.
Clinical Audit of Cardio Pulmonary Resuscitation Management in Adults Patient Units of Care by in Situ Simulation

Clinical audit of in-hospital cardiac arrest management by in situ simulation

Objectives: correct latent safety threats, knowledge gap, and crisis resource management (CRM)

Design: clinical audit, observational sudy. Primary outcome: In Hospital resuscitation scale. Exploratory outcomes: non technical skills, validated stress inventory, and questionnaire on perceptions of the simulation and organisational changes needed.


Eligibility Criteria:
Inclusion Criteria:

* team members: nurses, auxiliary nurses, residents, doctors, students

Exclusion Criteria:

* non volunteers
A Study of Abatacept in Patients With Active Ulcerative Colitis

The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active ulcerative colitis in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied

The Induction Period First Cohort (IP1C) arms (30/10 mg/kg and 10 mg/kg) were placebo-controlled arms that were used for the primary endpoint and its analysis. The Induction Period Second Cohort arms (IP2C 30/10 mg/kg and 10 mg/kg) were not placebo-controlled, their sole purpose being to provide sufficient numbers of participants for the maintenance phase. The first cohort (IP1C) was randomized to receive placebo or 1 of 3 doses of abatacept. Following completion of the IP1C randomization, a second cohort (IP2C) was randomized to receive 1 of 2 doses of abatacept. After all participants in the IP1C completed or discontinued, the data was locked and the formal analysis for the Induction Period primary endpoint was performed. Summary tables for the second cohort (IP2C) and the Maintenance and Open-label phases were generated from a second, subsequent data lock.

Eligibility Criteria:
Inclusion Criteria:

* Men or women 18 years or older
* Ulcerative colitis for at lease 3 months
* Moderate to severe active ulcerative colitis
* Inadequate response or intolerance to standard ulcerative colitis treatment