cyrilzakka/clinical-trials huggingface dataset:
A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women

The main objective of the study is to evaluate the persistence of the immunoglobulin G (IgG) antibody responses, specific to Alpha-like protein CN (AlpCN), Ribosomal Protein N (RibN), Alpha-like protein 1N (Alp1N), and Alpha-like protein 2 and 3 (Alp2-3N), after a primary vaccination with GBS-NN/NN2 in all participants.


Eligibility Criteria:
Inclusion Criteria:

* Participant living in Denmark or South Africa who has participated either in Trial MVX0004 (NCT05154578) or MVX0005 (NCT04596878) and has received at least 1 dose of the GBS-NN/NN2 vaccine.
* Participant who is able to read and understand and capable of giving personal signed informed consent.
* Participant who is willing and able to comply with scheduled visits, the investigational plan, and other trial procedures.
* Participant who is granting access to their trial-related medical records and to their trial materials from Trials MVX0004 or MVX0005, whatever is applicable.
* Participant who are expected to be available for the duration of the trial and who can be contacted by telephone during trial participation.

Exclusion Criteria:

* Any personnel involved in the conduct of the trial (and their family members), including, but not limited to, site staff members, MinervaX employees, and any vendor or contract research organisation (CRO) employees.
* Participant with confirmed Group B Streptococcus (GBS) infection since participation in Trial MVX0004 or MVX0005.
* Participant with any psychiatric condition, including recent (within the past year) active suicidal ideation/behaviour that may increase the risk of trial participation or, in the investigator's judgement, make the participant unsuitable for participation in the trial.
* Participant who participated in other trials involving investigational drug(s) or devices within 28 days prior to trial entry, and/or are participating in other trials involving investigational drug(s) or devices at trial entry, or plan to (continue to) participate in other trials involving investigational drug(s) or devices during this trial.
* Participant with known or suspected immunodeficiency or cancer or a family history of congenital or hereditary immunodeficiency.
* Participant receiving chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to trial entry. An immunosuppressive dose of glucocorticoid will be defined as a systemic dose ≥10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
* Participant who received blood, blood products, plasma derivatives, or any immunoglobulin preparations in the 12 weeks prior to trial entry or is planning to receive such products during this trial.
* Participant with current or history of drug or alcohol abuse, as judged by the investigator.
* Participant who received any marketed or investigational (other than GBS-NN/NN2 in the MVX0004 or MVX0005 Trial) GBS vaccines or who is planning to receive any marketed or investigational (other than GBS NN/NN2) GBS vaccines during this trial.
Evaluation of the Effect of Systemic Proteolytic Enzyme Therapy on Postoperative Inflammatory Response and QoL After Surgical Extraction of Impacted Mandibular Third Molars

1. To compare the postoperative pain between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day.
2. To compare the postoperative swelling (edema) between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day.
3. To compare the degree of trismus between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day.
4. Measure patients' perceptions of changes in their quality of life in the postoperative period and compare it between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day.

Evaluation of the effect of systemic proteolytic enzyme therapy on postoperative inflammatory response and quality of life after surgical extraction of impacted mandibular third molar.

The aim of this study is to evaluate the effect of systemic enzyme therapy(TibrolinTM) on the postoperative inflammatory response and the quality of life after surgical removal of impacted third molar. The study is designed and was implemented as a randomized controlled clinical study guided by Consolidated Standards of Reporting Trials (CONSORT) guidelines . Patients were randomly allocated to two groups (25patients per group). Group A included administration of SET after surgery and continued for 5 days post-surgery; Group B, a control group that would not receive the systemic enzyme therapy . The predictor variable was The use of systemic proteolytic enzyme (Tibrolin) or not .The primary outcome variables were pain and swelling , trismus,quality of life measured on 1st day (day of surgery), third day, and 7th after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Healthy patients over 18 years old of either gender.
* Patients who have impacted mandibular third molar.
* Ability to tolerate surgical procedure.
* Pell and Gregory's classification (Class I and class II, position A and B).

Exclusion Criteria:

* Patients with uncontrolled systemic diseases.
* Patients with history of chemotherapy or radiotherapy therapy to the head and neck region.
* Acute infection at the surgical site at time of operation.
* The presence of cysts or tumors associated with the impacted teeth.
* Pell and Gregory's classification (class III Position C)
Micronutrient Bioavailability From Wheat

The purpose of this study is to determine if physical disruption of wheat aleurone cell walls (micro-milling) increases micronutrient availability.

This research project is a short-term dietary intervention study to investigate the bio-availability of iron and zinc from wheat. Approximately 50% of iron and 30% of zinc in the United Kingdom diet is provided by cereals and cereal products (e.g. bread and breakfast cereals). The localisation of both iron and zinc metals in wheat is largely confined to the aleurone layer, a single layer of cells located between the centre (endosperm) and outer layers (testa and pericarp). The aleurone layer is removed during the production of white flour. For this reason, since 1953 it has been mandatory to add iron to flours at the mill to restore iron to levels present in wholegrain flour (The Bread and Flour Regulations, 1998).

The investigators have shown that aleurone cells are resistant to physical disruption and digestion as they pass along the gastrointestinal tract and are excreted intact in faeces. The investigators believe that disruption of wheat aleurone cell walls prior to food manufacturing would therefore increase iron and zinc availability. Using wholegrain flour and purified wheat aleurone flour the investigators have shown that micro-milling, a process which reduces particle size of flour from approximately 100μm to 10μm, ruptures the aleurone cell walls, and increases iron availability, i.e. the amount absorbed by intestinal cells, compared with flour produced using standard milling techniques (which does not break down the aleurone layer).

Based on these initial findings, the current study therefore has 2 main aims:

(i) to determine whether physical disruption of the aleurone (by micro-milling) in wholegrain flour increases iron and zinc availability from wholegrain bread.

(ii) to determine whether addition of micro-milled aleurone flour to white flour increases iron availability from white bread.

Eligibility Criteria:
Inclusion Criteria:

* Healthy pre-menopausal women
* Serum ferritin below 30 μg/L
* Plasma zinc below 13.8 μmol/L.

Exclusion Criteria:

* Allergic to gluten or wheat
* Pregnant
* Post-menopausal women
* History of alcohol or substance abuse
* History of Cardiovascular Disease, diabetes, cancer, kidney, liver or intestinal disease, gastrointestinal disorder or use of drugs likely to alter gastrointestinal function.
* Donated blood recently (within 3 months prior to screening visit)
* Volunteers planning to take any mineral or vitamin supplements during the course of the study.
Peritoneal Cavity Conditioning Decreases Pain, Inflammation and Adhesions

Full conditioning of the peritoneal cavity during laparoscopic surgery will decrease post-operative pain, inflammation and adhesion formation.

Full conditioning will decrease an inflammatory response of the peritoneum and decrease pain and adhesion formation.

Randomized controlled trial (RCT) comparing carbon dioxide to full conditioning (addition of oxygen, nitrous oxide, humidification and temperature control, dexamethasone and Hyalobarrier gel) Women undergoing laparoscopy for endometriosis, myomectomy or adhesiolysis will be randomized to either group and will be compared for pain (VAS scores); inflammation (White blood cells, CRP) and adhesions scored by second look laparoscopy.

Eligibility Criteria:
Inclusion Criteria:

* women undergoing laparoscopic excision of deep endometriosis (stratum 1), excision of endometrioma's (stratum 2) or excision of uterine myoma's (stratum 3) since this is severe surgery, associated with severe postoperative adhesions and since for most of these women fertility is important and hence the second look laparoscopy can be beneficial.
* Signed informed consent

Exclusion Criteria:

* women with a pre-existing condition increasing the risk of surgery such as clotting disorders, heart or lung impairment etc.-Any condition that might interfere with inflammatory parameters such as immunodeficiency, chronic inflammatory disease as Crohn's disease.
* Pregnancy
* Conditions associated with chronic pain as peripheral neuropathy, pathology of the vertebral column and osteo-articular disease. Conditions causing acute pain e.g. abdominal trauma
* a known allergic reaction to Hyalobarrier Gel Endo®
* A bowel lesion requiring a single or double layer suture. (given that for none of the anti-adhesion barriers safety has been proven following bowel lesions and suture)
iPSC Biobank of Biomarkers Diversity in Cardiovascular Disease

The Investigators will create a clinical database and a Biobank of stem cells derived from the blood of participants with cardiovascular disease. The Investigators will recruit participants from diverse racial and ethnic backgrounds with equal representation from both sexes. The Investigators expect to create stem cells and analyze the blood for protein biomarkers and genetic causes of cardiovascular disease. The stem cell biobank and clinical data will be a powerful tool for studying cardiovascular disease.

Cardiovascular disease is the leading cause of morbidity and mortality. The development of cardiovascular disease includes both genetic and epigenetic factors. Understanding their molecular and cellular mechanism is necessary to identify novel drug targets and treat the disease. Present in vitro and in vivo models of the disease do not mimic human pathophysiology, and obtaining the primary cells from the patients for the studies relevant to the cardiovascular and pulmonary system is difficult. Induced pluripotent stem cells (iPSCs) are derived from a person's blood cells and facilitate the discovery of cardiovascular disease mechanisms. The Investigators propose recruiting cardiovascular patients from diverse ethnic backgrounds and creating a rich clinical database using REDCap. Blood samples will be obtained from participants and used to create iPSCs. The participant will have DNA sequencing, and serum will be analyzed for protein biomarkers. The multi-omics data and reprogrammed iPSCs will be stored in the Cardiology and Critical Care (C3RP) laboratory at the Robarts Research Institute at Western University. The reprogrammed iPSCs can generate a limitless supply of cardiovascular tissue. Moreover, the iPSC-derived data will be correlated with clinical information, genetic sequencing, and protein biomarkers from serum analysis. The Investigators expect to create an iPSC biobank coupled with a rich clinical dataset, including genetic sequencing analysis and protein biomarkers that will enable the discovery of novel biomarkers and drug targets for cardiovascular disease.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18 to 80 years of age)
* Cardiovascular Disease (CVD)
* Cerebrovascular Disease (CBD)
* Peripheral Vascular Disease (PVD)
* Inherited Arrhythmias
* Cardiomyopathies
* Congenital Heart Disease (CHD)
* Aortopathy
* Hypertension
* Cardiometabolic Disease (CMD)

Exclusion Criteria:

* Younger than 18 years of age.
* Patients not able to provide consent.
Comparison Between Propofol Concentration in Exhaled Breath and Blood Plasma Using the Exhaled Drug Monitor "Edmon"

Edmon is the first Communauté Européenne (CE) marked medical device able to continuously measure propofol in the exhaled breath of patients under sedation or anaesthesia with propofol. Current scientific publications indicate that it makes sense from a pharmacologic point of view to measure propofol in the exhaled air.

If the present study can show the Edmon to be able to detect small differences in propofol plasma concentration it will underline the clinical value of measuring propofol in the exhaled breath. This might be an opportunity for a significant improvement in patient monitoring.


Eligibility Criteria:
* Inclusion criteria

  * Male or female patients undergoing elective surgical procedures
  * Expected duration of the surgical procedure \> 1h
  * General anaesthesia (TIVA) with propofol and remifentanil under orotracheal intubation
  * Medical need for an arterial line for an invasive haemodynamic monitoring during anaesthesia
  * Written informed consent
  * Age ≥ 18 years
  * ASA I-III
  * BMI \< 35 kg/m²
  * Women of child bearing potential: negative pregnancy test
  * BIS monitoring feasible (e.g. no surgical procedures on the frontal brain)
  * The patient is expected to be extubated in the OR after end of surgery
* Exclusion criteria

  * Patients with contraindications for propofol, remifentanil or for the planned anaesthetic procedure
  * Cardiac surgery
  * Lung surgery
  * Organ transplant procedures
  * Pulmonary diffusion anomalies (e.g. pulmonary fibrosis), known from medical history
  * Patients on renal replacement therapy
  * Participation in another interventional trial
  * Breastfeeding women
  * Unilateral lung ventilation
  * Emergency surgery
  * Patient is not able to give his/her written informed consent
  * Patients with a haemoglobin level below 10 g/dl
Safety and Efficacy of MCC-257 in the Treatment of Diabetic Polyneuropathy

The primary objectives of the study are to evaluate the efficacy and safety of three doses of MCC-257 in patients with mild to moderate diabetic polyneuropathy

The study will use a double-blind, randomized, placebo-controlled, fixed-dose, parallel-group design. Patients will be randomized equally to 1 of 4 treatment groups: MCC-257 20 mg, MCC-257 40 mg, MCC-257 80 mg, or placebo, given once daily for 24 weeks. The study will consist of 2 periods: 1) a screening period of up to 21 days prior to baseline, including a formal screening visit; and 2) a 24-week treatment period, during which patients will take the study treatment, and have various assessments performed during 4 visits.

Eligibility Criteria:
Inclusion Criteria:

* The patient is male or female, 18-70 years of age
* The patient has either type 1 or type 2 diabetes
* The patient has mild to moderate diabetic neuropathy
* The patient is free from other clinically significant illness or disease, as determined by medical history, physical examination, laboratory evaluations, and other safety tests

Exclusion Criteria:

* Being treated with anticoagulants other than aspirin, such as warfarin, digoxin, Plavix
* BMI\>40
* A significant disorder or a condition other than diabetes that can cause symptoms or physical conditions that mimic peripheral neuropathy or interfere with cognition
* Any proximal neuropathy, clinically evident nerve entrapment, or any focal trauma potentially affecting nerve function
* Women of childbearing potential who do not refrain from sexual activity or use adequate contraception
* Pregnant or lactating women
* An ALT or AST value \>2X upper limit of normal (ULN)
* Clinically significant cardiovascular disease within the last six (6) months
A Study to Compare the Blood Levels of Mim8 in Healthy Men When Administered With the DV3407-C1 Pen Injector or a Syringe and Cartridge

Novo Nordisk is developing the study medicine Mim8 for the treatment of haemophilia A. The study aims to show similar levels of Mim8 in blood when using a new pen injector, called DV3407-C1 pen injector, and when using a syringe and cartridge. The new pen injector is intended to facilitate the administration of Mim8 for patients with haemophilia A. The participants will get Mim8 as injection under the skin (subcutaneously) of the belly using the DV3407-C1 pen injector and a needle (hereinafter referred to as pen injector) or using a needle and syringe from a cartridge (hereafter called syringe and cartridge). The participants will receive one injection with Mim8, either with the DV3407-C1 pen injector or with a syringe and cartridge. The study participation will last up to 20 weeks. Only healthy men can take part in the study.


Eligibility Criteria:
Inclusion Criteria:

* Male aged 18-55 years (both inclusive) at the time of signing informed consent.
* Body mass index (BMI) between 18.5 and 29.9 kilogram per square metre (kg/m\^2) (both inclusive) at screening.
* Body weight between 60.0 and 100.0 kg (both inclusive) at screening.
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* Increased risk of thrombosis, e.g., known history of personal or first-degree relative(s) with unprovoked deep vein thrombosis.
* Any clinical signs or established diagnosis of venous or arterial thromboembolic disease.
* Factor VIII activity greater than or equal to (≥) 150 percent (%) at screening.
* Thrombophilia as identified by any of the below laboratory markers at screening:
* Protein C, protein S or antithrombin less than (\<) lower limit of normal (LLN)
* Factor II activity or activated protein C resistance \>upper limit of normal (ULN).
Hysteroscopic Tubal Occlusion Using Amacrylate With or Without Lipidol in Patients With Hydrosalpinx Prior to IVF

Hysteroscopic tubal occlusion using iso-amyl- 2-cyanoacrylate with or without Ethiodized oil (Lipidol) in patients with hydrosalpinx prior to IVF

hysteroscopic injection of iso-amyl- 2-cyanoacrylate with or without Ethiodized oil (Lipidol) in patients with hydrosalpinx requiring IVF. after one months and two months of the primary injection hysterosalpingography will be done to test for tubal occlusion.

Eligibility Criteria:
Inclusion Criteria: • Infertile women due to tubal factor with hydrosalpinx (unilateral or bilateral) prepared for IVF

Exclusion Criteria:

* • Any patient with acute pelvic inflammatory disease, endometritis, lower genital tract infection.

  * The presence of intrauterine synechiae that might hinder the proper hysteroscopic examination and tubal cannulation diagnosed by diagnostic hysteroscopy.
  * The presence of uterine anomalies that might hinder the proper hysteroscopic examination and tubal cannulation diagnosed by diagnostic hysteroscopy.
  * Undiagnosed genital bleeding.
Safe and Timely Antithrombotic Removal (STAR) Registry

This registry will capture real-world clinical use patterns and associated clinical outcomes with the use of CytoSorb for the removal of antithrombotic agents.

The STAR Registry will collect patient-level clinical data on antithrombotic removal with CytoSorb. The decision to use CytoSorb in this clinical setting is based on the clinical rationale of mitigating the high risk of bleeding events that is directly linked to the presence of the antithrombotic agent. This registry is to capture real-world clinical use patterns and associated clinical outcomes with the use of CytoSorb. Data of retrospective and prospective patients will be included in the registry. Safety will be assessed by collection of (at least possibly) device-related adverse events. Data collection is done up to 30 days post-operation.

Eligibility Criteria:
Inclusion Criteria:

* CytoSorb utilization for antithrombotic removal
* Informed consent for prospective registry participation

Exclusion Criteria:

• Use of CytoSorb for purpose other than antithrombotic removal
Detecting Chronic Subdural Hematoma With Microwave Technology

An open study evaluating the sensitivity and specificity of a microwave-based device, Medfield Strokefinder MD100, to detect chronic subdural hematoma, by comparing measurements on patients recruited for surgery of chronic subdural hematoma to an age- and gender-matched group of healthy volunteers.

This open study will enroll patients admitted for surgery of chronic subdural hematoma at the Department of Neurosurgery at Sahlgrenska University Hospital and compare them to measurements of healthy volunteers. Patients will be asked to participate in the study, as early as possible after admission. After physical examination, checking the inclusion/exclusion criteria, and after informed consent has been acquired, the microwave-based measurement will be performed. The diagnostic procedure is estimated to take 30 min whereof total subject measurement time will be less than five minutes. Healthy volunteers will be recruited in parallel and the same procedure as for the patients will be followed.

Safety will be followed throughout the study, and a safety follow-up will be performed 12 hours after the microwave-based investigation is finalized.

To avoid measurement bias all measurements, for both patients and healthy volunteers, will be performed by the same operator.

Eligibility Criteria:
Inclusion Criteria:

* Patient admitted for surgery of chronic subdural hematoma.
* A CT scan of the patient has been performed, within the latest 96 hours.
* The patient should be able to have a normal conversation and understand the information about the study, corresponding to Glasgow Coma Scale (Verbal Response) of 5.
* Patient/healthy volunteer should be ≥ 18 years of age.
* The patient/healthy volunteer has signed a written informed consent.

Exclusion Criteria:

* Females who are pregnant or breast feeding women.
* Patient/healthy volunteer has a shunt or other foreign object implanted in the brain.
* Patient/healthy volunteer participating in any other clinical study that could interfere with the result in the ongoing study.