cyrilzakka/clinical-trials huggingface dataset:
PARPi and Ovarian Cancer Survival

With the widespread use of PARP inhibitors (PARPi) as maintenance therapy in ovarian cancer, there is still a lack of real-world data from large samples regarding their impact on survival outcomes in advanced and recurrent ovarian cancer. This study aims to conduct a pragmatic cohort study to evaluate the impact of first-line and second-line maintenance treatment with PARPi on survival rates in patients with advanced and recurrent ovarian cancer. The genetic status, different PARPi drugs, and the use of anti-angiogenic inhibitor maintenance therapy or not is used as confounding factors.


Eligibility Criteria:
Inclusion Criteria:

Group 1:

* Patients newly diagnosed with stage IIIC or IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer between December 2013 and December 2024.
* Complete data on first-line treatment and maintenance therapy.
* Availability of follow-up data.

Group 2:

* Patients with platinum-sensitive first recurrence of any stage of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, diagnosed between December 2013 and December 2024.
* Disease progression occurring at least 6 months after the completion of the last platinum-based chemotherapy regimen.
* Complete data on second-line treatment and maintenance therapy.
* Availability of follow-up data.

Exclusion Criteria:

Group 1:

* Non-epithelial tumors, borderline tumors, clear cell carcinoma, mucinous carcinoma.
* Missing first-line or follow-up data.

Group 2:

* Non-epithelial tumors, borderline tumors, clear cell carcinoma, mucinous carcinoma.
* Patients with second relapse.
* Platinum-resistant patients, such as those who had disease progression during chemotherapy or within 6 months after platinum-based chemotherapy.
* Missing second-line or follow-up data.
How Common is Hypoglycaemia in Older People With Diabetes Who Fall?

The purpose of this study is to use 24 hour continuous glucose monitoring in older patients with diabetes who present with symptoms of falls, or dizziness, or confusion, that may indicate hypoglycaemia.

Background and study aims Patients with diabetes can be treated with medications (such as insulin or sulfonylureas) that can lower the sugar levels too much (hypos). A hypo means that the brain does not get enough energy. A person can become confused, dizzy, pass out, and/or have a fall.

Older people with diabetes often seek treatment in hospital for symptoms such as falls, dizziness or feeling muddled. Health care professionals will order tests to investigate the possible causes for the fall, being muddled or dizzy, which can include a review of medications, checking blood pressures and the heart.

However, it has previously been difficult to obtain 24-hour blood sugar monitoring in older people with diabetes to check if hypos could be an important contributing factor to their falls and dizzy spells.

Continuous Glucose Monitoring (CGM) allows non-stop monitoring with a sensor that sits just under the skin. This sends sugar readings to a smartphone every few minutes (via Bluetooth) for 10 days. This enables full evaluation of the amount of time a person's sugar is in the target range, and the time in the low/high ranges. Medical research with CGM has revealed that some older people are suffering from substantial periods of hypos that they are not aware of.

During this study, older people with diabetes will be asked to wear a CGM device for 10 days to investigate possibility of hypos.

Eligibility Criteria:
Inclusion Criteria:

* 75 years and older with diabetes
* Treated with glucose-medications which carry a high risk of hypoglycaemia (sulfonylureas and/or insulin)
* Presenting to hospital with a fall and/or symptoms suggestive of unrecognised hypoglycaemia (such as dizziness, feeling muddled).

Exclusion Criteria:

* Treatment with metformin alone
* Lack of capacity,
* Not willing to participate,
* Terminal illness (less than one-year life expectancy).
* Evidence of bruising, bleeding, cellulitis and/or skin tears on the upper arms or abdomen.
Effects of Native Whey or Milk Supplementation on Adaptations to 12 Weeks of Strength Training in Young and Elderly

The aim of this study is to investigate the long term adaptations to 11 (elderly) or 12 (young) weeks of strength training when supplemented with native whey or milk. The investigators hypothesize that native whey will give greater increases in muscle hypertrophy and strength than milk.

Increasing or maintaining muscle mass is of great importance for populations ranging from athletes to patients and elderly. Resistance exercise and protein ingestion are two of the most potent stimulators of muscle protein synthesis. Both the physical characteristic of proteins (e.g. different digestion rates of whey and casein) and the amino acid composition, affects the potential of a certain protein to stimulate muscle protein synthesis. Given its superior ability to rapidly increase blood leucine concentrations to high levels, whey is often considered the most potent protein source to stimulate muscle protein synthesis. Native whey protein is produced by filtration of unprocessed milk. Consequently, native whey has different characteristics than milk. Of special interest is the higher amounts of the highly anabolic amino acid leucine in native whey.

The higher levels of leucine can be of great interest for elderly individuals as some studies in elderly has shown an anabolic resistance to the effects of protein feeding and strength training. By increasing levels of leucine one might overcome this anabolic resistance in the elderly.

The aim of this double-blinded, randomized, partial cross-over study is to compare the changes in muscle hypertrophy and strength after a 11 (elderly) or 12 (young) week training intervention with daily supplementation of either 2x20g of native whey or milk proteins in young and elderly individuals. In order to explain potential differences between supplements an acute study investigating acute responses in blood amino acid concentrations and intracellular signalling is planned, in a subgroup of participants, before and after the training intervention.

The investigators hypothesize that native whey will induce greater muscle hypertrophy and strength gains than milk.

Eligibility Criteria:
Inclusion Criteria:

* Healthy in the sense that they can conduct training and testing
* Able to understand Norwegian language written and oral
* Between 20 and 45, or above 70 years of age

Exclusion Criteria:

* Diseases or injuries contraindicating participation
* Use of dietary supplements (e.g. proteins, vitamins and creatine)
* Lactose intolerance
* Allergy to milk
* Allergy towards local anesthetics (xylocain)
Post-market Study to Capture Information Regarding Performance of Lyric2

Randomized post market study comparing Lyric to Lyric2 capturing information regarding comparative performance and safety.

Randomized post market study comparing extended wear hearing aids Lyric to Lyric2 capturing information regarding comparative performance and safety.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-90 years at the time of enrollment in the study
* Mild to moderately-severe hearing loss bilaterally, or unilaterally if normal hearing in other ear
* Fluent in English
* Willingness to comply with all study requirements

Exclusion Criteria:

* Scuba dives or sky dives
* Underwater swimming or dives into the water
* Handicaps that would restrict participation in all the evaluations
* Hearing loss of neural or central origin
* Unrealistic expectations regarding benefits and limitations inherent in the devices
* Chemotherapy within the last six months
* Compromised immune system
* Radiation to head or neck
* Perforated tympanic membrane
* History of cholesteatoma
* Active outer or middle ear pathology
* High levels of anticoagulant therapy
* Insulin-dependent and/or uncontrolled diabetes
* Contact dermatitis
* Bleeding disorder
* Unwillingness or inability to comply with all study requirements
Camrelizumab in Patients With Unresectable Hepatocellular Carcinoma

Primary liver cancer is the second most common cause of cancer death in China, and hepatocellular carcinoma (HCC) represents more than 80% of liver cancer cases. The majority of HCC cases present at an advanced stage, and are thus not amenable to surgery. Immunotherapies, including PD-1 and PD-L1 inhibitors, alone or combined with other regimens, have shown encouraging clinical activity in unresectable HCC. Camrelizumab, a humanised monoclonal antibody against PD-1, has been shown to block the binding of PD-1 to PD-L1 and consequently inhibit the immune escape of tumour cells， which has been approved for the second-line treatment of advanced HCC. This observational study aims to evaluate the safety and efficacy of camrelizumab in Chinese unresectable HCC in the real world.

Primary liver cancer is the second most common cause of cancer death in China, and hepatocellular carcinoma (HCC) represents more than 80% of liver cancer cases. The majority of HCC cases present at an advanced stage, and are thus not amenable to surgery. Immunotherapies, including PD-1 and PD-L1 inhibitors, alone or combined with other regimens, have shown encouraging clinical activity in unresectable HCC. Camrelizumab, a humanised monoclonal antibody against PD-1, has been shown to block the binding of PD-1 to PD-L1 and consequently inhibit the immune escape of tumour cells，which has been approved for the second-line treatment of advanced HCC. This multi-center, open-label, observational study aims to evaluate the safety and efficacy of camrelizumab in Chinese unresectable HCC in the real world. This study also aims to evaluate the treatment of camrelizumab in subgroups, to provide information of treatment regimens and efficacy in clinical practice. The anticipated sample size is 1000, and the camrelizumab-based treatment will be determined by the investigator.

Eligibility Criteria:
Inclusion Criteria:

* 1. Volunteer to participate in this study and sign an informed consent form; 2. Age ≥ 18 years; 3. Hepatocellular carcinoma confirmed/clinically confirmed by histopathology, cytology or imaging

Exclusion Criteria:

* 1. Documented pregnant or breastfeeding women;
* 2. Patients who are participating in any interventional trials beyond clinical practice.
Immunotherapy Administered Under the Tongue to Treat Dust Mite Allergy

This study will investigate sublingual immunotherapy (SLIT), a treatment involving antigens placement under the tongue to help asthma sufferers build a tolerance to the allergy-causing substances. Specifically, this study will determine the effectiveness of SLIT at two different dosing regimens for patients with intermittent mild asthma caused by dust mites.

Asthma is a serious lung condition that is the leading cause of long-term illness in children. Many common household substances can trigger or worsen an asthma attack. It is important for people to reduce household allergens and learn effective treatments for specific types of asthma. Inhaled short-acting beta agonist such as albuterol is the standard treatment for mild, intermittent asthma. However, recent studies have shown that adding allergen-specific immunotherapy to your current asthma therapy can help to control asthma symptoms. This study will determine the safety and effectiveness of SLIT in two different dosing regimens in treating patients with house dust mite-induced allergic rhinitis/mild intermittent asthma.

Participants will be randomly assigned to receive low dose SLIT, high dose SLIT, or placebo for at least 12 months. House dsut mite-induced allergy skin tests will be performed at study entry, at selected timepoints throughout the study, and at the end of the study. The tests will determine whether SLIT creates an immune tolerance state as well as whether SLIT acts via local or systemic immunological systems.

Eligibility Criteria:
Inclusion Criteria:

* House dust mite-induced allergic rhinitis/mild intermittent asthma

Exclusion Criteria:

* Use of previous allergy immunotherapy for house dust mite asthma
* Pregnancy or breastfeeding
Early Identification and Predictive Parsing for High Risk Group of Schizophrenia

An accurate identification of individuals at ultra-high risk (UHR) based on psychometric tools to prospectively identify psychosis as early as possible is required for indicated preventive intervention. The diagnostic comparability of several psychometric tools is unknown. To address the psychometric comparability of the CAARMS, SIPS and BSABS for subjects who are the immediate family and three-generation blood kinship of patients with schizophrenia. To verify the viability and reliability of the three instruments for these subjects. subjects who all are immediate family and three-generation blood kinship of patients with schizophreniawere interviewed. All the subjects were assessed for a UHR state by three psychometric tools including CAARMS, SIPS and BSABS. The psychometric diagnosis results including at risk of psychosis (UHR+), not at risk of psychosis (UHR-), and Psychosis. Demographic and clinical characteristics interviewed by these three instruments were also measured. The inter-rater agreement was assessed for evaluation of the coherence of the three scales. Transition rates of CAARMS, SIPS and BSABS for UCH+ subjects within 2 years were also recorded.There is good diagnostic agreement between the CAARMS, SIPS and BSABS towards identification of UHR subjects who are immediate family and three-generation blood kinship of patients with schizophrenia. Also, these three instruments are reliable and valid for assessing and detecting at risk mental states in these subjects.


Eligibility Criteria:
Inclusion Criteria:

* all are immediate family and three-generation blood kinship of patients with schizophrenia

Exclusion Criteria:

-
Versartis International Trial in Adults With Long-Acting Growth Hormone

A Phase 2, open-label dose-finding safety study of individualized monthly VRS-317 dosing for five months in adults with GHD.

A Phase 2, dose finding safety study to evaluate an individualized monthly VRS-317 dosing regimen in adults with GHD. This is an open-label, international, multicenter study with VRS-317 treatment for five months. This treatment period will include monthly dose titrations until a subject's mean IGF-I SDS value is within a target range for two consecutive months. Subjects will be stratified into three cohorts based on sensitivity to rhGH.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects of childbearing potential must have negative pregnancy test and use appropriate contraceptive methods
* Subjects must have documented GHD during adulthood.
* Subjects taking other hormone replacement therapy must have been on a stable course of treatment for at least 3 months.
* Subjects with underlying disorders responsible for the subject's GHD must have been clinically stable for at least 6 months.
* Subjects receiving daily rhGH injections must washout for 14 days.
* Subjects must provide signed informed consent.
* Subjects must have a BMI (kg/m2) between 19.0 and 35.0.

Exclusion Criteria:

* Subjects with diabetes mellitus or inadequate glucose control
* Subjects with untreated adrenal insufficiency.
* Subjects with free thyroxine outside the normal reference range.
* Subjects currently taking oral glucocorticoids, except for physiological maintenance doses of oral glucocorticoids in subjects with multiple pituitary hormone deficiencies.
* Subjects with current significant cardiovascular disease, heart insufficiency of NYHA class \> 2.
* Subjects with current significant cerebrovascular, pulmonary, neurological, renal, inflammatory, or hepatobiliary disease.
* Subjects with current papilledema.
* Subjects with a history of persistent or recurring migraines.
* Subjects with current edema (≥ CTCAE Grade 2).
* Subjects with current drug or alcohol abuse.
* Subjects with a documented history of HIV, current HBV or HCV infection
* Subjects with a prior history of malignancy excluding adequately treated non-melanoma skin cancers or in situ carcinoma of the cervix.
* Women who are pregnant or breastfeeding.
* Subjects with a significant abnormality in Screening laboratory results
Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

The main objective of this study is to investigate whether controlled dose reduction of IL17 or IL23 inhibiting biologics is not inferior compared to usual care in psoriasis patients. Therefore, a pragmatic, multicentre, randomized, controlled, non-inferiority study will be carried out.

Rationale: Biologics are very effective treatments for psoriasis. Research indicated that the dose of TNFα-blocking biologics can be reduced in a proportion of patients. Safety profiles can improve and costs can be reduced if the reduction of the dose is successful. Recently, the newest generation of biologics entered the market: interleukin (IL) 17 and IL23 inhibitors. It is not yet known whether dose reduction of these agents is possible, and to what extent they can be reduced. The timely investigation of the possibilities for dose reduction of new biologics is therefore important.

Objectives: The primary goal is to investigate whether controlled dose reduction of IL17 or IL23 inhibiting biologics is not inferior compared to usual care. This is measured by comparing the proportion of long-term disease flares between the two groups (dose reduction group versus usual care group). Secondary goals are: determining the proportion of patients with successful dose reduction, clinical effectiveness measured with the Psoriasis Area and Severity score (PASI) score, Dermatology Life Quality Index (DLQI) scores, predictors for successful dose reduction, safety, and cost-effectiveness of dose reduction. Pharmacokinetic (PK) analysis will be performed for modeling.

Study design: a multicenter, practice-oriented, pragmatic, randomized, controlled, non-inferiority study.

Study population: Patients treated with the newest generation of biologics (IL17 or IL23 inhibitors), with long-term stable low disease activity at a normal dose. A total of 244 patients will be randomized (2:1) to dose reduction or continuation of usual care.

Intervention: Dose reduction by interval prolongation in 2 steps to a maximum decrease of 50% of the original dose when disease activity (PASI) and quality of life index (DLQI) remain low.

Eligibility Criteria:
Inclusion Criteria:

* Plaque psoriasis (primarily)
* Treatment for at least 6 months with IL23 or IL17 inhibitor in a normal dose (dose advised by the label)
* PASI≤ 5 at inclusion and in previous 6 months (if no PASI scores are available, it should be clear from the patient record that psoriasis was clear/almost clear in previous 6 months).
* DLQI ≤ 5 at inclusion

Exclusion Criteria:

* Another indication than plaque psoriasis as the main indication for biologic use (e.g. patient receives biologic for rheumatoid arthritis as the main indication).
* Concomitant use of systemic immunosuppressants other than methotrexate or acitretin (e.g. prednisone, cyclosporine etc).
* Severe comorbidities with short life-expectancy (e.g. metastasized tumor).
* Presumed inability to follow the study protocol.
Anesthesia During Neurophysiologic Monitoring in Scoliosis Patients

When patients have spinal surgery, electrodes are placed on the body to measure motor evoked potentials (MEP) and somatosensory evoked potentials (SSEP). Many hospitals only use IV anesthesia because they feel that measuring MEP and SSEP is easier using IV anesthesia. At this hospital the investigators typically use inhaled anesthesia and are able to successfully measure MEP and SSEP. This is a study to find out if one method of anesthesia is better than the other for measuring MEP and SSEP.


Eligibility Criteria:
Inclusion Criteria:

* Patients with idiopathic scoliosis.

Exclusion Criteria:

* Patients with neuromuscular scoliosis.
Disease Course in an IBD Cohort in the Era of Biological Treatment

The aim of the study is to do a 7-year follow-up of a consecutive inception cohort of 562 adults and children diagnosed and registered with inflammatory bowel disease in 2003-04 in order to evaluate the consequences of biological therapy in the treatment of IBD. The cohort is established after the implementation of biological agents in the treatment of IBD and the investigators hypothesis is that a) Severe disease course in IBD can be predicted by phenotypic presentation by serological, genetic, clinical and endoscopic characteristics to be used as guidance in the selection of treatment strategy and b) Introduction of biological treatment changes the course of disease in IBD and reduces the need of surgical procedures.

Methods: Medical records will be reviewed to register the use of medication, flare ups (medical and surgical) and hospital admissions. Diagnosis, disease localization and behavior will be evaluated. At outpatient visits patients will get a clinical examination, blood and faeces will be collected to biobank and patients will be offered an endoscopical examination. The Montreal classification, The Harvey \& Bradshaw's activity index (CD) and the SCAAI score (UC) will be used to describe disease localization, extent, behavior and severity. An electronic database will be established in use of processing data.


Eligibility Criteria:
Inclusion Criteria:

* All patients wil be followed up and diagnosis will be reassessed.

Exclusion Criteria:

* Non-IBD (after reassessing diagnosis)
Assessment of the Diagnostic Capacity of the Mini-broncho Alveolar Lavage Performed Through a Suction Catheter

The aim of this study is to develop a safe and effective technique to take sample for lower respiratory tract cultures easy to perform in conditions of acute respiratory failure and spontaneous ventilation for patients admitted in intensive care unit for acute infectious pneumonia and non intubated. The investigators perform sample collection with a mini bronchoalveolar lavage catheter introduced by nasotracheal way through a suction catheter. The purpose of the study is to assess the microbiological diagnostic capacity of this new technique.

At the moment we lack an effective and safe technique to obtain lower respiratory tract cultures for patient with mild serious infectious pneumonia admitted in intensive care unit and non intubated. Invasive procedure may worsen respiratory distress and non invasive procedure such expectorated sputum culture is not enough effective. The purpose of the study is to assess the microbiological diagnosis capacity of a new technique for taking samples from the lower respiratory tract: mini bronchoalveolar lavage performed by naso tracheal way through a suction catheter.Each consecutive patient admitted in intensive care unit for a community acquired or nosocomial pneumonia and not requiring intubation and mechanical ventilation will be included. Written informed consent by patient himself will be required. For each patient, after the introduction of a suction catheter, an endotracheal aspiration will be performed. Then, the mini bronchoalveolar lavage will be performed through the suction catheter with a specific catheter.The whole time of the procedure is about ten minutes.Expectorated sputum will also be ordered for each patient.This study is a pilot and prospective study.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Radiological diagnosis of pneumonia (community acquired or nosocomial)
* No microbiological diagnosis known
* Indication for culture of lower respiratory tract
* Admission in intensive care unit required

Exclusion Criteria:

* Age lower than 18
* Bronchospasm
* Coagulopathy ( Platelets count below 100 000/mm3, prothrombin time less than 50%, activated partial thromboplastin time ratio higher than 2)
* Intubation with mechanical ventilation
* Known microbiological diagnosis
* Incapacity for consenting himself to the study