cyrilzakka/clinical-trials huggingface dataset:
Genotyping of Metastatic Colorectal Cancer Patients for Precision Medicine Clinical Trials

The goal of delivering the right drug to the right cancer patient (precision medicine) requires a detailed understanding of how genomic alterations are linked to drug response. The purpose of this study is to intercept at point-of-care a large cohort of newly diagnosed mCRC patients to determine if it is possible to obtain personalized genetic information from each subject's tumor (tissue and blood) to triage treatment choices. In case of target positivity, patients will be conveyed, whenever possible, to self-standing, independent, hypothesis-driven POC trials as soon as they exhibit resistance to standard of care treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmed adenocarcinoma of the colon or rectum with metastatic disease not amenable to salvage surgery.
* Planned primary treatment at FUNNEL center or FUNNEL center referring Hospital.
* Availability of fresh tissue or a paraffin block for genotyping NOT older than 1 year.
* Age ≥18.
* ECOG PS 0-1.
* No major comorbidities that would preclude the potential enrolment of the patient in a clinical trial.
* Signed informed consent.

Exclusion Criteria:

* Symptomatic brain metastases.
* Gastro-intestinal abnormalities, inability to take oral medication, any condition affecting absorption.
* History of another neoplastic disease (except basal cell carcinoma of the skin or uterine cervix carcinoma in situ adequately treated), unless in remission for ≥ 5 years.
* No major comorbidities that would preclude the potential enrolment of the patient in a clinical trial.
SwissNET - a Registry for Neuroendocrine Tumours in Switzerland

Gastroentero-pancreatic neuroendocrine tumours (GEP-NETs) are regarded as a fairly rare disease. They are derived from the neuroendocrine system of the gastrointestinal tract and the pancreas and share common clinical features. So far, there is still uncertainty about the cell biology and mechanistic regulation of these tumours. Therefore targeted treatment is limited and management challenging. Treatment options include surgery, medical and ablative therapy, and more recently peptide-receptor radionuclide therapy. In order to better understand the characteristics of GEP-NETs and to evaluate treatment strategies, the SwissNET registry aims at the collection of data from patients presenting with a GEP-NET in Switzerland. Data will be entered prospectively and anonymized in a specifically designed database after the patient has given informed consent. All hospitals and general practitioners are invited to report on patients with a GEP-NET diagnosis and to participate to the registry. Data will be evaluated within regular time frames, focussing on types of GEP-NETs, treatment modalities and patient outcomes (e.g. mortality, hospitalisation rate), thereby contributing to the better understanding of these tumours.

Background

Gastroentero-pancreatic neuroendocrine tumours (GEP-NETs) are generally classified as rare diseases. Little is known about their cell biology and their mechanistic regulation. During the last years, the incidence of GEP-NETs is continuously increasing worldwide. In parallel, novel treatment options are currently evaluated which may substantially improve prognosis of patients with NETs. Data on such tumours in Switzerland, however, is scarce and treatment strategies vary throughout the country.

Objective

To systematically and prospectively collect clinical information of patients with GEP-NETs in Switzerland based on a histologically confirmed diagnosis.

Methods

All NETs of both, gastrointestinal and pulmonary origin are included provided that patients have given informed consent. Data will be entered prospectively and anonymised in a specifically designed database. Contributing centres and general practitioners are visited by a study nurse, patient files are analysed and data is transferred to the database. In case of conflicting evidence, questions are resolved in collaboration with a review board of SwissNET. Evaluation of treatment modalities and patient outcomes (e.g. mortality, hospitalisation rate) will take place within regular time frames.

Eligibility Criteria:
Inclusion Criteria:

* Neuroendocrine tumor irrespective of primary tumor location
* Diagnosis in Switzerland
* Given informed consent
Characterizing Skin Microbiome Change in Atopic Dermatitis

Atopic dermatitis (AD), also known as eczema, is an inflammatory disease of the skin affecting a large proportion of the pediatric and adult patient population. Chronic itching and eczematous lesions lead to a high burden of disease and associated patient morbidity with higher infection rates, emotional stress and associated psychological disease. The microbiome community contributes to human health through several mechanisms. Current research suggests that derangements in the normal microbiota may lead to inflammatory bowel disease, allergy, and metabolic syndromes. Specific to dermatology, new literature has demonstrated that changes in the microbiome may play a role in the development of atopic dermatitis.

With this study, the investigators hope to characterize the baseline atopic dermatitis skin microbiome and monitor the evolution of the participants skin microbiome during and after treatment with anti-inflammatory topical medications, specifically the Food and Drug Administration (FDA)-approved phosphodiesterase inhibitor, crisaborole ointment 2% (Eucrisa).


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 2 years or older at the time of consent.
2. Patients may be male or female.
3. Patients may have any skin phototype.
4. Patients with a clinical diagnosis of atopic dermatitis according to the Hanifin and Rajka criteria. Atopic dermatitis diagnosis must be stable at least for 1 month per caregiver or patient.
5. Atopic dermatitis affecting at least 5% of the patient's body surface area with at least two distinct lesional sites.
6. Atopic dermatitis must meet a score of mild to moderate on the baseline Investigator's Static Global Assessment (iSGA).
7. If greater than or equal to 18 years old at the time of consent, is able to provide written informed consent and will comply with all study procedures. If less than 18 years old at the time of consent, parent or guardian is able to provide written informed consent with all children greater than or equal to 7 years old at the time of consent also providing written assent, and will comply with all study procedures.

Exclusion Criteria:

1. Patients less than 2 years old at the time of consent.
2. Patients unable to provide written informed consent.
3. Patients must not have used systemic biologic therapy, systemic immunosuppressive therapy, or systemic immunomodulating therapy within three months of baseline visit.
4. Patients must not have had phototherapy within three months of baseline visit.
5. Patients must not have used topical corticosteroids or topical calcineurin inhibitor within 28 days of baseline visit.
6. Patients must not have previously been treated with topical phosphodiesterase-4 inhibitor.
7. Patients must not have a known hypersensitivity reaction to crisaborole or any of its known vehicle components.
8. Patients must not have any active skin infection at the time of screening.
9. Patients must not have any other overlying inflammatory disease such as psoriasis.
10. Patients must not be currently pregnant, breastfeeding or planning pregnancy during the study.
Comparison of Penetrating Keratoplasty and Deep Lamellar Keratoplasty With the Big Bubble Technique for Keratoconus

it is a randomized clinical trial to compare deep lamellar keratoplasty (DLK) Using big bubble technique and Penetrating Keratoplasty (PK) in patients with keratoconus

In this randomized clinical trial 50 keratoconic eyes of 50 patients randomly assigned in two groups: 25 patients underwent DLK with the big bubble technique and the other 25 patients underwent PK with the standard technique using hessburg - Barron trephine. One surgeon performed all operations using a 16 bites separate 10-0 nylon sutures. We used A-scan ultrasonic biometry for measuring vitreous length (VL) before surgery. If VL≥15.50mm, a trephine 0.25mm larger than recipient and if VL was \<15.50mm, a trephine 0.50 mm larger than recipient were considered. Selective suture removal was started 3 months after operation. quality of vision endothelial cell changes and correlation between refractive outcome and VL in relation to donor-recipient disparity, were measured and analyzed in both PK and DLK 15 mos postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* moderate to severe keratoconus
* contact lens intolerance
* low visual acuity due to anterior stromal scar
* age between 15 to 50 years

Exclusion Criteria:

* posterior stromal scar with descemets membrane involvement
* history of hydrops
* fuchs endothelial dystrophy
* glaucoma
* cataract
* history of intraocular surgery
* history of vernal keratoconjunctivitis
* intraoperative complications
* reoperation (resuturing- regraft)
Hip Socket Erosion Study

The aim of this exploratory retrospective study is to gain a better understanding about the occurrence of acetabular erosion in patients after after hip hemiarthroplasty. The main objectives are i) to summarise a selection of basic patient characteristics of all patients of ≤ 75 years of age with a femoral neck fracture who have received either HA or THA, ii) to explore the proportion of patients after HA who developed acetabular erosion in the first years post-surgery and iii) to explore the proportion of patients after HA for whom acetabular erosion was the main reason for conversion surgery from HA to THA. A secondary objective is to assess the observer reliability of, and explore the association between, the Baker classification grading and Köhler line measurements.

All participants approached for participation in the main phase of the study will be asked to give their written informed consent to use their patient data. Patients who are willing to participate will also be asked to complete a short paper survey to collect data that is not available from their health records.

Some orthopaedic surgeons believe that relatively 'young' older patients (aged ≤ 75 years) who have sustained a femoral neck fracture should be treated with hemiarthroplasty (HA) instead of total hip arthroplasty (THA). The rationale behind this belief is that THA is more time consuming, has greater associated surgical morbidity and may increase the risk of hip dislocation and subsequent revision surgery. On the other hand, HA is believed to accelerate acetabular erosion (i.e. wear) over time, which may ultimately lead to the need for conversion surgery from HA to THA. Due to a lack of research in this area, it is unclear how often the development of acetabular erosion in patients after HA actually occurs. This makes it difficult for orthopaedic surgeons to make an informed choice between HA or THA surgery for this patient group.

This is an exploratory retrospective study using existing electronic patient data of patients adhering to the inclusion criteria of the study, i.e. patients of ≤ 75 years of age who have had HA after a femoral neck fracture.

Eligibility Criteria:
Inclusion Criteria:

* having had a displaced femoral neck fracture that was subsequently treated with hemiarthroplasty
* aged \< 75 years at the time of surgery
* have at least two post-operative radiographs (with at least six weeks between them) available for acetabular erosion measurements.

Exclusion Criteria:

* patients diagnosed with rheumatoid arthritis, osteoporosis, hip dysplasia or a previous hip fracture of the ipsilateral hip.
Bioequivalence of Vildagliptin Tablet Manufactured in China Compared to Imported Vildagliptin Tablet in Chinese Healthy Volunteers

This study will evaluate the bioequivalence as well as rate and extent of absorption of vildagliptin tablet manufactured by Beijing Novartis Pharma Ltd. compared to the imported vildagliptin tablet in Chinese healthy volunteers.

This trial is not recruiting patients in the United States,


Eligibility Criteria:
Inclusion Criteria:

* Chinese healthy male subjects age 18 to 40 years of age included
* In good health
* Male subjects using a double-barrier local contraception for the entire duration of the study up to study completion visit and refraining from fathering a child in the three months following last study drug administration.
* Body mass index within the range of 19 to 24 kg/m2 and weigh at least 50 kg

Exclusion Criteria:

* Smokers
* Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Paracetamol is acceptable.
* Participation in any clinical investigation within 4 weeks prior to dosing.
* Donation or loss of 400 ml or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
* Significant illness within two weeks prior to dosing.
* A past personal or close family medical history of clinically significant cardiac abnormalities.
* History of:

  * Fainting, low blood pressure when standing, irregular heartbeats,
  * Acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated),
  * Clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis)
  * Known hypersensitivity to the study drug or similar drugs
  * Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or jeopardize participation in the study.
  * Immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
* Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
* Drug or alcohol abuse within the 12 months prior to dosing

Other protocol-defined inclusion/exclusion criteria may apply
Investigation of Efficacy of Improved Acetaminophen Labeling

The purpose of this study is to evaluate, through brief, one-on-one cognitive interviews, the efficacy of 'enhanced' acetaminophen messages and icons in improving consumer understanding and use of prescription (Rx) and non-prescription (over-the-counter, OTC) acetaminophen containing products compared to the current standard.

Acetaminophen is a pain reliever and fever reducer found in many over-the-counter (OTC) analgesics as well as prescription (Rx) products commonly prescribed at discharge from the emergency department. 1 An estimated 36% of Americans ingest acetaminophen at least once a month.1, 2 While acetaminophen is generally safe and effective when used at recommended doses, acetaminophen overdose has surpassed viral hepatitis as the leading cause of acute liver failure (ALF) in the United States.2-4 Moreover, one half to two-thirds of overdoses leading to acute liver failure are unintentional, suggesting the root cause may be poor understanding of medication labeling or failure to recognize the consequences of exceeding the recommended maximum daily dosage.2-4 On-going studies by this research group have shown patient misunderstanding of dosing instructions and warnings associated with OTC medicines to be prevalent.

It has also been suggested that patients receiving prescription medications containing acetaminophen may not be informed or aware of the potential risk of acetaminophen overuse when taking prescription products in combination with over-the-counter pain relievers.1 This is supported by the finding that a third of narcotic users were simultaneously using an OTC acetaminophen containing product in a multicenter study of ALF cases.2 To address the growing concern of acetaminophen misuse, in June 2009 the US Food and Drug Administration (FDA) convened a panel to discuss the maximum dose recommendations of acetaminophen found in OTC medications. The panel concluded that there was a notable lack of available evidence on consumer understanding and use of over-the-counter acetaminophen products. Studies are needed to explore patients' 1) knowledge of potential acetaminophen overdose when using prescription analgesics simultaneously with non-prescription acetaminophen and 2) avenues available to increase awareness of potential acetaminophen overdose from misuse of both OTC and Rx acetaminophen containing medicines.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* English speaking

Exclusion Criteria:

* Visual or hearing impairments
* Moderate to severe cognitive impairments
The EveryPrem Project: Evaluating the INTER-NDA for Standardized Neurodevelopmental Screening at 2 Years of Age for Children Born Preterm.

Neurodevelopmental follow-up of infants at high-risk such as preterm born is necessary in order to early detect impairments and early start a supportive/therapeutic intervention. Valid tools should be available for screening infants with developmental problems even where resources are limited. Such screening would ensure an adequate medical care during and after hospital discharge as well as evidence-based parental pre- and postnatal counselling. While in Switzerland, these tools are specifically needed for the neurodevelopmental surveillance of moderate to late pretem born infants, in low- and mid-income countries, they are needed to monitor the whole population of preterm born infants.

To fill this important gap, the present study aims to determine whether it is feasible to extend neurodevelopmental screening (currently offered to only a very small part of children born preterm), by using a new cost-effective neurodevelopmental assessment, the INTERGROWTH-21st Neurodevelopment Assessment (INTER-NDA, www.inter-nda.com Assessment) at age 2 years.

The pirmary objectives of the study are:

1. In very preterm born infants (born \< 32 weeks' gestation)

   - To assess the concurrent validity of the INTER-NDA with the Bayley-III\[13\] at 2 years of corrected age in VPT infants.
2. In moderate to late preterm infants (born between 32 and 36 weeks' gestation) - To screen neurodevelopment performances at corrected 2 years of corrected age in MLPT infants by means of the INTER-NDA and to compare values with international INTER-NDA standard values.

Eligibility Criteria:
Inclusion Criteria:

* Former patient of the Department of Neonatology of the University Hospital Zurich
* Born between 01.01.2019 and 31.12.2021, i.e. aged 18 to 30 months at the time of the research visit
* Gestational age below 370/7 weeks
* Parent consent

Exclusion Criteria:

* Genetically defined syndrome (including chromosomal aberration) or inborn error of metabolism adversely influencing life expectancy or neurodevelopment.
* Major congenital malformations requiring surgical correction or potentially affecting neurodevelopmental outcome.
* Hypoxic ischemic encephalopathy after perinatal asphyxia defined as grade 2 or 3 according to Sarnat and Sarnat\[19\].
* Neonatal drug withdrawal syndrome or known maternal substance consumption of following illicit drugs during pregnancy: cocaine, heroin, Lysergic acid diethylamide (LSD), 3,4-Methylenedioxymethamphetamine (ecstasy), phencyclidine (PCP), and other amphetamine/methamphetamine.
* Children of parents who are not speaking German
Therapeutic Exercises and Stabilization Exercises Given After Manual Therapy

The study was conducted to determine and compare the effects of the therapeutic exercises and stabilization exercises given to the patient after the manual therapy session on pain, neck range of motion, daily living activities and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-65,
* having neck pain for 3 months or longer,
* was diagnosed with chronic neck pain by a specialist.

Exclusion Criteria:

* People with neurological diseases,
* who had previous surgery in the cervical region,
* who had medulla spinalis tumors,
* vascular pathologies,
* fractures,
* osteoporosis,
* rheumatoid arthritis problems were not included in the study.
Early Diagnosis for Ocular Ischemia Syndrome Using Arterial Spin Labeling Magnetic Resonance Imaging Technique

1. To evaluate ocular blood perfusion status and the possibility of craniocerebral vascular lesions of patients with ocular ischemia syndrome (OIS) using arterial spin labeling (ASL) magnetic resonance imaging technique.
2. To evaluate the specificity, sensitivity and accuracy of arterial spin labeling (ASL) magnetic resonance imaging technique in OIS diagnosis, compared with the traditional routine examination method.


Eligibility Criteria:
Inclusion Criteria:

* Ocular ischemia syndrome group: Patients diagnosed with ocular ischemia syndrome;
* Age-related macular degeneration group (Control group): Patients diagnosed with age-related macular degeneration;
* Age: 50-80 years;
* Sex: all;
* Patients signed written informed consent.

Exclusion Criteria:

* Fundus fluorescein angiography (FFA) clear images cannot be obtained due to refractive media problems(such as corneal leukoplakia, severe cataract, vitreous hemorrhage, etc.) ;
* Patients with contraindications for FFA;
* Patients was unable to perform magnetic resonance rmaging (MRI) test;
* Patients with history of bleeding and cerebral infarction;
* Patients with a history of surgery within 3 months;
* Patients who had participated in other clinical trials within 3 months;
* Patients who disagree and refuse to participate in the trial.
Association of Anticholinergic Burden With Onset of Delirium in Older Adults With Alzheimer Dementia:

Drugs with anticholinergic properties are commonly prescribed to older persons despite growing evidence of their significant adverse effects. However, limited data are available concerning their contribution to time of onset of delirium. This study aimed to determine the potential association of higher anticholinergic burden to early-onset of delirium superimposed dementia in the older adult.


Eligibility Criteria:
Inclusion Criteria:

* 65 years and older and diagnosis or fellow-up of Alzhemier dementia in outpatient clinic.

Exclusion Criteria:

* The patients with a history of other than Alzhemier dementia or neurodegenerative disease (epilepsy, multiple sclerosis, Parkinson disease, etc.), terminal illness (malignancy, advanced organ failure) were excluded.
The Utility of 18F-fluorocholine PET/CT in the Imaging of Parathyroid Adenomas

We assessed sensitivity of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism (PHPT).

We prospectively enrolled 65 consecutive patients with PHPT who underwent neck ultrasound (US) and parathyroid scintigraphy (99mTc/99mTc-MIBI dual phase). Twenty-two patients had unsuccessful parathyroid surgery prior to the study. PET/CT scans were performed 65.0 ± 13.3 min after injection of 218.5 ± 31.9 MBq of 18F-fluorocholine (FCH). Three experienced nuclear medicine physicians assessed the detection rate of hyperfunctioning parathyroid tissue. Response to parathyroidectomy and clinical follow-up served as a reference test. Per-patient sensitivity and positive predictive value (PPV) were calculated for patients who underwent surgery.

Eligibility Criteria:
Inclusion Criteria:

* primary hyperparathyroidism and neck US and the dual-phase 99mTc/99mTc-MIBI SPECT/CT scintigraphy performed prior to the PET/CT scan

Exclusion Criteria:

* pregnancy
* patient's lack of consent to the examination