cyrilzakka/clinical-trials huggingface dataset:
An International Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B

Alprolix (rFIXFc) is a recombinant extended half-life coagulation factor product. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Alprolix in the on-demand and prophylactic treatment of haemophilia B.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of haemophilia B
* Have started Alprolix treatment prior to enrolment visit, or at enrolment prescribed treatment with Alprolix irrespective of participation in the study
* Signed and dated informed consent provided by the patient, or the patients legally acceptable representative for patients under the legal age, before any study-related activities are undertaken. Assent should be obtained from paediatric patients according to local regulations.

Exclusion Criteria:

* Participation in an investigational medicinal product trial at enrolment visit
A Study Investigating the Safety, Recovery, and Pharmacodynamics of Multiple Oral Administrations of SNIPR001 in Healthy Subjects

This is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose, dose escalation study in healthy participants, investigating the safety, tolerability, recovery, and PD of multiple oral administrations of SNIPR001.

Approximately 36 healthy male and female participants will be randomized to one of 3 active oral doses of SNIPR001 or matching placebo, administered twice a day (BID) for 7 days. Subjects will be followed up until 6 months after receiving the last dose of SNIPR001.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Male or female healthy subject defined as no known clinically relevant organ abnormality, or disease diagnosis, as per Investigator discretion
* No clinically significant abnormalities indicated by safety laboratory test results
* Age between 18 years and 65 years
* E. coli present in feces sample
* Normal defecation pattern (at least once daily)
* Willing to participate in the study and provide fecal samples

Exclusion Criteria:

* Treatment with antibiotics or any other prescription medication within the last 30 days prior to or during screening
* Use of probiotics (not including dairy products) within the last 30 days prior to or during screening
* Smoking (cigarettes, pipes, vaping products, etc.) within the last 3 months prior to or during screening
* 6 months prior to or during screening, recent history of alcohol or drug abuse, or current regular alcohol consumption of more than 14 units per week (one unit of alcohol equals one beer (285 ml), one glass of wine (125 ml), or one glass of spirits (25 ml))
* Positive alcohol or drugs of abuse test
* Pregnancy or lactating or intention of becoming pregnant (all females to agree to use highly effective contraception (defined as those, alone or in combination, that result in a low failure rate i.e., less than 1% per year) for the entire study duration
* Obesity as defined by WHO i.e., BMI\>32 kg/m2
* Known to be HIV-positive
* Known active hepatitis B and/or hepatitis C infection
* Known congenital or acquired immunodeficiency
* Allergy to any component of the trial drug and ant-acid treatment
* Regular use of medications that affect gastrointestinal motility e.g., antidiarrheals, stool softeners and laxatives, GLP-1 analogues
Severe Soft Tissue Infections: Perspectives of Patients and Significant Others

Severe necrotizing soft tissue infection (NSTI), including necrotizing fasciitis, is a life threatening infection that spreads quickly to cutis, sub-cutis, fasciae and muscles. Approximately 40% of all patients with infections caused by S. Pyogenes develop a streptococcal toxic-shock syndrome. In these cases the mortality rates exceed 40% in spite of adequate treatment with antimicrobials. Due to the rapid progress, the extensive damage on soft tissues and high risk of death, the microbes are called "flesh-eating bacteria". The present study is a spin-off of the larger EU funded INFECT study, looking at the experiences of patient and family to understand the impact on every day life. The present prospective mixed methods study has the potential to provide important knowledge regarding the occurrence of early signs and symptoms of NSTI, quality of life 6 and 24 months after diagnosis, and how the care and treatment can be optimized and organized in a person/patient and family centered way. The study also aims at validate the SF 36 questionnaire for this group of patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with necrotizing fasciitis and their significant others
* Age above 18 yrs

Exclusion Criteria:

* Persons with dementia or severe psychiatric illness
* Persons that do not master the Scandinavian language
Acceptability, Feasibility, and Preliminary Impact of a Web-based, HIV Prevention Toolkit With Cisgender Male Couples in Lima, Peru

This digital couples-based HIV/STI prevention intervention project will determine preliminary efficacy to improve uptake of evidence-based strategies and a tailored prevention plan among cisgender male couples who are in a relationship (defined as greater than 3 months or more).

The project draws on our strong findings from the preliminary work we conducted in Lima. The 3-year project will update and adapt an existing digital health couples-based HIV/STI prevention toolkit intervention that showed promise for reducing couples' HIV risk. The intervention is theoretically grounded in Couples Interdependence Theory for health behavior change. The project is a 6-month pilot randomized control trial with 60 at-risk male couples using a delayed, educational control condition of 3 months. Our Specific Aims are to: 1) Assess feasibility to retain 60 consented and eligible male couples in a 6-month pilot RCT through quantitative measurement of enrollment and retention/attrition rates, and by reason for attrition; 2) Describe acceptability of the adapted toolkit intervention using mixed methods23 from 3 data sources. At last follow-up, partners responses to the Health Information Usability Evaluation Scale24 and other survey items (e.g., 3 things liked best/least about the toolkit, features for improvement) will be captured, along with the additional details they will share about their experiences during the individual-level, qualitative exit interview; 3) Examine preliminary impact of the toolkit intervention on couples': a) formation and adherence to a tailored risk-reduction plan and agreement; b) relationship functioning (e.g., communication); c) use of/adherence to evidence-based HIV/STI prevention strategies; and d) HIV/STI incidence. Preliminary impact will be assessed via changes in couples' outcomes a-d over time between trial arms, and for all couples.

Eligibility Criteria:
Inclusion Criteria:

1. being assigned male at birth and currently identifying as male (cis-gender);
2. having had anal sex with each other in the past 3 months;
3. referring to each other as being in a relationship, defined as "someone you feel emotionally or romantically committed to above all others, and may be referred to as partner, husband, partner, etc.";
4. being in a relationship with each other for 3 months or longer;
5. being at least 18 years of age;
6. not having any history of intimate partner violence since their relationship began;
7. self-reporting not feeling coerced by their partner to take part in the study activities;
8. having their own Internet/web-connected device (e.g. smartphone, laptop, tablet, computer);
9. living in the Lima metro area and planning to live there for the next 6 months;
10. willing to receive an in-person rapid HIV test (if applicable);
11. willing to be tested for other STIs and use swabs to self-collect their own specimens; and
12. willing to attend an in-person appointment at baseline and at 6 months.

Exclusion Criteria:

-Does not meet one or more of the inclusion criteria
Albumin Utilization in Adult Cardiac Surgical Patients : a Multicentre Prospective Cohort Study

The goal of our proposed multicentre prospective cohort study is to characterize perioperative usage patterns of crystalloids and albumin, as well as key patient outcomes, in cardiac surgical patients. Results obtained from this observational study will be combined with the results of other studies to clarify the optimal role of albumin and other blood products in the perioperative management of cardiac surgical patients. This study will also address numerous other knowledge gaps in the area of perioperative blood product management and fluid administration in cardiac surgery and define a collaborative group to support future research in this field.

This is a prospective observational study of 100 patients undergoing cardiac surgery, with a target of 50 participants per site. There is a clear need for a large-scale, multicentre, randomized trial to determine the role of albumin in cardiac surgical patients, particularly in higher risk cohorts such as patients with poor ventricular function and those undergoing complex procedures. A major obstacle to conducting this trial is a lack of data regarding perioperative albumin prescribing across providers and centres, including the indication for use, timing, formulation, and dose used in different settings (i.e., in the operating room, in the intensive care unit, and on the ward). Additionally, there is little data describing variability in typical resuscitation practices, and whether centre-level differences are associated with patient outcomes. This information is critical to inform trial design, including clinically relevant trial arms and endpoints. Thus, the goal of the proposed research is to obtain information on albumin use in cardiac surgical patients across Canada that will contribute to the design of a definitive randomized controlled trial in this population.

Eligibility Criteria:
Inclusion Criteria:

* All adult (≥18 years old) patients undergoing cardiac surgery (with or without the use of cardiopulmonary bypass) will be eligible.

Exclusion Criteria:

* Patients who are unable to consent to the study or who refuse participation will be excluded.
New Methods to Detect a Decrease in Heart Function

The purpose of this study was to evaluate the changes in heart function during onset of spinal anesthesia using a new and less invasive method, the LidcoTMplus.

The incidence of hypotension during onset of spinal anesthesia in elderly patients varies from 27% to 80% depending on which definition being used. Studies of cardiac output (CO) has shown that it is maintained or only slightly decreased .

Unfortunately, the time-resolution in these studies is often several minutes, and the description of changes is consequently often a start-to-end relation rather than a description of the dynamic changes during onset of spinal anesthesia.

A recent advance in measuring CO is the LiDCOTMplus hemodynamic monitor, which has proved reliable compared to pulmonary artery catheters in various intensive care settings. This monitor allows for beat-to-beat measuring during various procedures and thus early warning of hemodynamic events.

Another method with potential for early warning of decreased perfusion is near-infrared spectroscopy (NIRS). NIRS is used for continuous and non-invasive monitoring of cerebral oxygen saturation (ScO2) and even a small reduction has recently shown to predict maternal hypotension during caesarian section.

The aim of our study was to describe the changes in CO during onset of spinal anesthesia in elderly patients using a method with high time-resolution. We also attempted to evaluate NIRS as predictor of hemodynamic events.

Eligibility Criteria:
Inclusion Criteria:

* Age 60 years or older
* Elective orthopedic or plastic lower limp surgery
* in spinal anesthesia

Exclusion Criteria:

* Body weight \<40 kg
* Currently in treatment with lithium
* Evidence of aortic valve regurgitation
Use of a Liquid Supplement Containing 2 Human Milk Oligosaccharides (HMOs) in Preterm Infants

This is a prospective, randomized, double-blind, placebo-controlled trial in preterm infants conducted at least 4 centers in France, consisting of 2 parallel groups. The experimental group will receive a neonatal supplement containing 2 specific HMOs. The control group will receive a placebo neonatal supplement that does not contain any HMOs, but matched to the experimental product in energy content.

This study will include a total of approximately 86 male and female preterm infants born between 27 and 32 weeks' gestational age with birth weight ≤1700 g, who are younger than 7 days of age.

The primary objective of the study is to demonstrate the safety and tolerance of HMOs in preterm infants by monitoring weight gain rates in both of the two randomized groups.


Eligibility Criteria:
Inclusion Criteria:

* Infant's birth weight ≤1700 g.
* Infant's gestational age ≥ 27 weeks + 0 days and ≤ 32 weeks + 6 days.
* Infant is clinically stable
* Infants are eligible to start HMOs / placebo as soon as possible after birth, but still within the first 7 days of life.
* Written informed consent has been obtained from the parents/legally acceptable representative (LAR).

Exclusion Criteria:

* Parents not willing / not able to comply with the requirements of study protocol.
* Infants receiving ongoing prophylactic antifungal therapies.
* Infants experiencing early onset sepsis.
* Major congenital or chromosomal abnormality known to affect growth.
* Liver failure.
* Severe intrauterine growth restriction (IUGR) as defined by having birth weight less than 2nd percentile on the Fenton growth chart.
* Peri-/intra-ventricular haemorrhage (grade 3-4 in Papille classification) .
* Infant in critical condition needing intubation or inotropic agents for treatment.
* Infant requiring prolonged (more than 3 doses) of steroid treatment.
* Infants' participation in another interventional clinical trial that would have significant impact on current study's results.
* Infants who have already achieved Full Enteral Feeding (FEF) prior to enrolment, using the definition accepted by neonatal unit as per standard practice (150 mL/kg/day).
A Trial Comparing Deep Versus Moderate Neuromuscular Block - in Low Pressure Pneumoperitoneum

Live kidney transplantation is first choice for patients with end-stage kidney disease. Therefore, the safety and well-being of kidneys donors are highly important objectives in live kidney donation. Low pressure pneumoperitoneum can decrease postoperative pain and therefore also concomitant use of opioids.

However low pressure pneumoperitoneum can also decrease peri-operative conditions. In this trial the researchers will investigate whether peri-operative conditions during low pressure pneumoperitoneum can be optimized by the use of deep neuromuscular block.

Eligibility Criteria:
Inclusion Criteria:

* obtained informed consent
* age over 18 years

Exclusion Criteria:

* chronic use of analgesics or psychotropic drugs
* use of non-steroidal anti-inflammatory drugs shorter than 5 days before surgery
* known or suspect allergy to rocuronium or sugammadex
* significant liver or renal dysfunction
* pregnant or breastfeeding
Treatment of Hyperuricemia With Rasburicase in Patients With Acute Lymphoblastic Leukemia or High Grade Lymphoma

In this study the efficacy and tolerability of two approaches to treat and prevent hyperuricemia is tested in patients with acute lymphoblastic leukemia or high-grade lymphoma with high risk of tumor lysis syndrome. Both arms are compared by randomisation. In one arm patients receive during pre-phase chemotherapy conventional prophylaxis with allopurinol whereas in the other arm Rasburicase is used.


Eligibility Criteria:
Inclusion Criteria:

* patients of the GMALL B-ALL/NHL-Study 2002
* patients of the GMALL-Study 07/2003
* patients of the GMALL-Study Elderly 1/2003 which fulfill the following criteria:
* bulky disease (\> 7.5 cm)
* high LDH (\> 2 x UNL)
* uric acid \>8 mg/dl/ \>475µmol/L at diagnosis
* leukocytes \> 30 000/µl

Exclusion Criteria:

* exclusion Criteria of the GMALL B-ALL/NHL Study 2002 or the GMALL-Study 07/2003 or GMALL-Elderly 1/2003 and:
* asthma or severe, live-threatening atopic allergy in history
* hypersensitivity against Uric acid
* Glucose-6-Phosphate-Dehydrogenase deficiency
* pretreatment with Rasburicase or Urikozyme™
Study of Alofanib in Patients With Metastatic Gastric Cancer

This is a non-randomized multicenter phase 1b clinical trial of the safety and pharmacokinetics, as well as the preliminary efficacy of monotherapy with alofanib, an allosteric fibroblast growth factor receptor 2 inhibitor, in patients with advanced gastric cancer who have exhausted the resource of standard therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed gastric cancer (adenocarcinoma)
* Progression of the disease (clinical and/or radiological) on previous standard systemic therapy
* Measurable lesions according to the RECIST 1.1 criteria
* Possibility to assess the amplification of FGFR2, fusion of FGFR2 genes, overexpression of FGFR2, phosphorylation of FRS2
* ECOG PS 0-2
* Age \>= 18 years old
* Adequate function of organs
* Absence of any psychological, family, social or geographical circumstances that could potentially serve as obstacles to the implementation of the study
* Patients capable of childbearing should use an effective method of contraception
* Signed Informed Consent

Exclusion Criteria:

* Participation in another clinical study and concomitant treatment with any research drug or any study of antitumor therapy, including radiation, within 28 days before inclusion in this study
* Presence of metastases in the central nervous system and / or carcinoma of the meninges at the time of inclusion in the study
* Presence or history of present signs of any condition, therapy or laboratory abnormalities that could limit the interpretation of the results of this study
* Any malignant tumor within the previous 5 years, with the exception of adequately cured cervical cancer in situ or squamous cell skin cancer, or basal cell skin cancer with limited growth, subject to adequate control over the course of this disease
* Pregnancy
* Known positive status for human immunodeficiency virus (HIV) or active hapatitis B and C
* Surgery within 7 days before the first dose of the study drug
* Signs of bleeding or hemorrhagic diathesis
Monthly Itraconazole Versus Classic Homeopathy for Treatment of Recurrent Vulvovaginal Candidiasis (RVVC)

A prospective study to evaluate the efficacy of classic homeopathic therapy compared to maintenance itraconazole therapy with and without additional exogenous lactobacillus for treatment of recurrent Candida vaginitis.

Objective:

Antimycotics effectively treat sporadic and recurrent vulvovaginal candidiasis (RVVC). Classic homeopathy (CH) is also used to treat this condition. We compared the efficacy of CH and itraconazole in reducing the frequency of RVVC episodes.

Design:

Single-centre, prospective, randomized.

Sample:

One-hundred-and-fifty patients with a history of RVVC and an acute episode of VVC.

Methods:

Women were randomised into 3 groups: itraconazole with lactobacilli (group 1), itraconazole without lactobacilli (group 2) and CH (group 3). Itraconazole treatment of acute infection was followed by a 6-months maintenance regimen with monthly single-day itraconazole (200 mg bid). Thereafter, patients were followed without treatment for 6 months. Women in group 1 were given additional vaginal lactobacilli for six days per month. CH treatment was performed for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years, premenopausal
* Negative pregnancy test
* Signed informed consent
* At least 4 Episodes of Candidiasis within the last year
* Candida detectable by culture
* Negative Hepatitis- and HIV-Serology
* No Allergy to Itraconazole

Exclusion Criteria:

* Under 18 years
Estimate for Dietary Intakes and Hemodialysis Patients

The aim of this clinical research is to evaluate the relevance of using the EPA slide to estimate dietary intakes in dialysis patients. The obtained results will be compared with the reference technique validated by the HAS: food intake over 3 days.

The aim is also to improve the global management of dialysis patients and improve their quality of life. The aim is to evaluate a quick and easy-to-use tool whose use has been demonstrated in hospitals but for which no study has been carried out in an ambulatory hospitalization context.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be able to understand and voluntarily sign an informed consent form
* Patient with chronic end stage renal failure treated with hemodialysis.
* Patient with age \>= 18 years

Exclusion Criteria:

* Patient treated by peritoneal dialysis
* Patient with age \< 18 years
* Patient with intellectual limitations that may limit the comprehension of questionnaires
* Patient with communication disorders or verbal comprehension
* Patient not French speaking
* Patient with enteral nutrition
* Patient having been hospitalized for less than 2 months
Intracranial Pressure (ICP) Monitoring Following Traumatic Brain Injury (TBI)

The aim of this retrospective cohort study is to evaluate complications rates, indications, and the utility of follow-up imaging studies of ICP measurement in severe TBI patients.


Eligibility Criteria:
Inclusion Criteria:

* Severe Traumatic Brain Injury (GCS\<9 on arrival)
* Implantation of invasive intracranial parenchymal ICP monitoring

Exclusion Criteria:

* incomplete data records
Trial of Adaptive 18F-FDG-PET Biological Intensity-modulated Radiotherapy (BG-IMRT) in Patients With Head and Neck Tumor

This study will evaluate the feasibility of higher and prolonged dose escalation concentrated in the intra-tumoral regions which are FDG-avid after two weeks of radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Head and neck tumor
* Aged \> 18 years