cyrilzakka/clinical-trials huggingface dataset:
A Randomised Controlled Trial of Face Masks and Hand Hygiene in Reducing Influenza Transmission in Households

This study will test the effectiveness of face masks and hand cleaning in preventing the spread of influenza within households

Randomised controlled trial of surgical masks and alcohol hand wash among approximately 6069 Hong Kong residents who have a household member diagnosed with influenza. Influenza in index member and secondary infection will be documented with rapid influenza tests and PCR. Minimal risk to participants.

Eligibility Criteria:
Inclusion Criteria:

* Member of family with influenza infected member

Exclusion Criteria:

* Age less than 2 yr
Cancer Predisposition Testing by Family-based Whole-genome Sequencing (WGS) in Every Child With Newly Diagnosed Cancer

Assessment of the utility of family-based (trio) whole-genome sequencing for cancer predisposition testing in sequential newly diagnosed paediatric and adolescent cancer patients

Cancer Predisposition Syndromes (CPS), caused by germline mutations in cancer predisposition genes (CPG) are heritable disorders associated with an increased risk of developing certain types of cancer.

Knowledge of CPG will advance the understanding of tumorigenesis, improve patient care, and facilitate genetic counselling of patients and families. But the prevalence of CPS in Australian children with cancer and the psychosocial impact of germline sequencing to identify CPG have not been studied.

The clinical benefit of family-based WGS in every new child with cancer compared with conventional predictive factors is currently unknown. By testing every child with newly diagnosed cancer the aim is to determine the utility of this approach and its impact on participants and families.

The principal objective of the proposed multicentre prospective study is establish the clinical benefit and utility of family-based WGS to identify underlying CPS in every newly diagnosed child with cancer.

Eligibility Criteria:
* New diagnosis of malignancy
* Age ≤ 21 years
* Written informed consent

Psychosocial component:

* Participants (≥ 12 years)
* Parent/caregiver(s) of participants
* Healthcare professionals involved in the care of patients enrolled in the study
TIPS Combined With Microwave Ablation in HCC Patients With Refractory Ascites

Transjugular intrahepatic portosystemic shunt (TIPS) could effectively decrease portal hypertension-related complications. This study intends to evaluate the efficacy and safety of TIPS combined with subsequent microwave ablation in HCC patients with refractory ascites.

Hepatocellular carcinoma (HCC) patients with refractory ascites (RA) have a very poor prognosis, and there are no effective treatments recommended by the guidelines. TIPS could downgrade the ascites and improve Child-Pugh scores. TIPS has been a common management model for RA for end-stage liver disease. There is no prospective study evaluating TIPS plus thermal ablation. Thus, the investigators carried out this prospective, single-arm study to find out it.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-70 years
2. Diagnosis of HCC based on the European Association for the Study of the Liver
3. Tumor diameter ≤ 3cm
4. Refractory ascites based on International Ascites Club: (a) intensive diuretics (spironolactone 400 mg/d combined with furosemide 160 mg/d) and sodium-restricted diet (\<90 mmoVd) for at least 1 week have no response; (b) lack of response to diuretic therapy; (c) early recurrence of ascites within 4 weeks; (d) Diuretic-induced complications. The grading of ascites was divided into mild ascites, moderate ascites, and large or gross ascites

Exclusion Criteria:

1. Congestive heart failure or severe valvular heart failure
2. Uncontrolled systemic infection or inflammation
3. Macroscopic vascular invasion or extrahepatic metastasis
4. Severe pulmonary hypertension
5. Severe renal insufficiency (except hepatogenic renal insufficiency) (6) rapidly progressive liver failure
6. Diffuse malignant liver tumor
7. Contrast agent allergy
A Phase Ⅰ Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-5817 Injection

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-5817 when administered subcutaneously (SC) as single ascending doses in adults who are affected by obesity.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to complete this study in strict accordance with the clinical study protocol.
2. Males or females aged 18-55 years old (inclusive).
3. Subjects who are generally healthy as judged by the investigator based on medical history, vital signs, physical examination, laboratory tests and electrocardiogram (ECG) results.
4. Body weight change (difference between the maximum body weight and the minimum body weight within 3 months) of no more than 5 kg within the past 3 months.
5. Female subjects of childbearing potential must agree to take highly effective contraceptive measures and avoid egg donation from the signing of the informed consent form to 6 months after the last dose, and must have a negative blood pregnancy test result before administration and not be breastfeeding. Male subjects whose partners are women of childbearing potential must agree to take highly effective contraceptive measures and avoid sperm donation from the signing of the informed consent form to 6 months after the last dose.

Exclusion Criteria:

1. Known or suspected allergy to any ingredient in the investigational medicinal products or related products; or history of multiple and/or severe allergies to drugs or food, or history of severe anaphylaxis.
2. History of or suffering from major diseases of cardiovascular, endocrine (except primary obesity), mental, neurological, digestive, respiratory, blood, immune or genitourinary systems, which are not suitable for participation in this study as judged by the investigator.
3. Subjects who have had severe trauma or undergone major surgical procedures within 6 months before screening, or who plan to undergo surgery during the study.
4. Subjects who have participated in and used any other clinical trial drugs or medical device treatments within 3 months prior to screening or plan to do so during the study period, or within 5 half-lives of the investigational drug before screening (whichever is longer).
5. Significant changes in diet and exercise habits within 1 month before screening, or failure to maintain a basically stable lifestyle such as diet and exercise during the study.
6. Known or suspected history of drug abuse or substance abuse, or positive urine drug screening during the screening period.
7. Other situations that may interfere with the evaluation of the study results or are not suitable for participating in this study as judged by the investigator.
Long Term Vascular Changes in Type 1 Diabetes

The main purpose of this study is to investigate progression of late complications of diabetes during the last ten years in a well characterized cohort of type 1 diabetes with a long duration of the disease, and to define factors responsible for the progression of late complications.

Despite intensively research in the field of hyperglycaemia and coronary heart disease in type 1 diabetes it is still not known in detail how hyperglycaemia leads to damage of the vessels.

The aims of the present proposal are therefore two-fold:

1. To study in detail the progression of atherosclerosis (and micro vascular complications) in a well characterized cohort of type 1 diabetes with a long duration of the disease. This project will be a continuation of the Oslo study, a cohort started in 1982, with the last follow-up study in 1999/2000.
2. To define factors responsible for the progression of coronary heart disease (and micro vascular complications) in this cohort.

Eligibility Criteria:
The original criteria from 1982:

Inclusion Criteria:

* Age 18-45 years
* Diagnosis of type 1 diabetes at \< 30 years of age, disease duration \> 7 but \< 30 years
* C-peptide \< 0, 1 nmol/l

Exclusion Criteria:

* Serum creatinine \> 150 µmol/l
* Diastolic blood pressure \<100mmHg
* Overt nephropathy
* Proliferative retinopathy
* Pregnancy
* A history of neuropathy
* Other chronical disease
* Treatment with other drugs except insulin and oral contraceptives
Circulating Tumor DNA Guided Treatment Monitoring in Advanced Lung Cancer

The study is a prospective randomized interventional study including patients with advanced non-small cell lung cancer, receiving immunotherapy, with the aim of optimizing treatment monitoring. The study aims to investigate the clinical utility of liquid biopsy monitoring in order to reduce the numbers of inefficient treatments and needless toxicity - and to explore the cost-effectiveness and cost-utility of introducing liquid biopsy monitoring in daily clinical practice.

Lung cancer is the leading cause of cancer-related death worldwide with Non-Small Cell Lung Cancer (NSCLC) being the most common subtype. Performance status deterioration due to progressive symptoms and toxicity by treatments are major challenges in managing advanced NSCLC patients. Moreover, standard treatment monitoring by radiologic scans is often imprecise. This technology has limited sensitivity as only a visible increase or decrease in tumor mass can be evaluated, making interpretation challenging and conclusions of whether patients benefit from treatment indefinite. Interpretation of radiologic scans has been further challenged after implementation of immunotherapy, causing immunotherapy-induced recruitment of immune cells resembling increment in tumor size, called "pseudo-progression." More sensitive methods are highly needed to reduce ineffective treatments and needless toxicity. Liquid biopsy has the potential to overcome these challenges by measuring molecular changes with high precision in a dynamic manner. Recent studies have demonstrated its promising potential as a biomarker predictive of treatment efficacy and overall survival. In a recent real-life study, investigators found that ctDNA measurements could reduce 33% of likely inefficient treatments and clarify 79% of non-conclusive CT-scans, highlighting the clinical potential. A randomized interventional multicenter study will be performed, investigating the true clinical potenial of liquid biopsy compared to standard monitoring by radiological scans. A total of 350 patients with advanced NSCLC will be included in the study from three Departments of Clinical Oncology. In the interventional arm, liquid biopsy monitoring will be the basis for treatment discontinuation before the standard two years of immunotherapy in patients reaching a complete molecular response in plasma. Thus clarifying the question if treatment duration can be reduced for the benefit of patients and health cost.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed, histologically verified, Non-Small Cell Lung Cancer (NSCLC)
* Advanced or locally advanced disease without curative intended treatment options
* Age \> 18 years
* Eastern Cooperative Oncology Group (ECOG) score of Performance Status (PS) 0-1
* Measurable disease according to the iRECIST criteria version 1.1.
* Eligible to first line immunotherapy (monotherapy)
* Signed informed consent

Exclusion Criteria:

* Targetable alterations in EGFR, ALK or ROS-1
* Other active cancers
Community Based Mental Health Screening and Referral

This feasibility study aims to evaluate the implementation of a community-based mental health screening and referral intervention for flood-affected women in a rural district of Dadu, Sindh, Pakistan. The quasi-experimental study involves training Lady Health Workers (LHWs) to screen women of reproductive age for mental health concerns, and referring those in need to local healthcare facilities, where doctors at the healthcare facility will reassess and provide psycho-counseling. It also includes community group sessions focused on mental health awareness and resilience-building. The objective is to assess the intervention's acceptability, feasibility, and effectiveness to inform future mental health initiatives, especially in disaster-prone regions.

This study evaluates the feasibility and implementation of a community-based mental health screening and referral designed for flood-affected women in a rural district of Dadu, Pakistan. The intervention involves the active engagement of Lady Health Workers (LHWs) to screen women of reproductive age for mental health concerns, utilizing simple screening tools. Women identified as potentially having a mental health disorder will be referred to local Basic Health Units (BHUs) or Rural Health Centers (RHCs) for further identification and counseling by trained healthcare staff. Individuals with severe symptoms will be referred to tertiary care facilities.

The study also involves community-based group sessions by the lady health workers to raise mental health awareness, address stigma, and build resilience among the target population, including resilience to climate change-related hazards such as flooding. These group sessions will focus on coping mechanisms, stress management, and fostering a supportive community environment.

The study follows a quasi-experimental design with data collected at baseline and end-line. This approach allows the research team to evaluate the intervention's acceptability, scalability, and impact on mental health outcomes. Findings from this feasibility study will inform the design of larger-scale mental health interventions tailored to disaster-affected populations in Pakistan.

Eligibility Criteria:
Inclusion Criteria:

* Women of reproductive age (WRA) 18-49 years in the targeted area
Effects of Various Bariatric Surgical Procedures on Intestinal Triglyceride-rich-lipoprotein (TRL) Metabolism in Obese Patients

Morbidly obesity (body mass index 40 kg/m²), the most serious, is more and more frequent. Cardiovascular diseases are the first cause of morbidity and mortality. An excess of TRL particles is one of the characteristics, represents a major cardiovascular risk factor. The overproduction of the intestinal TRL (which apoprotein B48 is the specific tracer) is recently recognized of insulin-resistance and the atherogenous role of these intestinal TRL has been shown. In front of this important overmortality, the bariatric surgery quickly developed. Three main procedures are performed: 2 based exclusively on the gastric restriction (the adjustable gastric banding and the sleeve gastrectomy) and one associating a malabsorption (the gastric bypass).

It is a monocentric, prospective, comparative study. After identification of the eligible subjects, the kinetics (production and clearance rates) of the intestinal TRL will be performed in the hospital, using a stable isotope method (5,5,5-D3-L-Leucine), in 3 groups of obese patients (12 patients per surgery procedure), before and 6 months after the surgery

Eligibility Criteria:
Inclusion Criteria:

* Men or women from 18 to 65 years old
* Subject having a BMI included between 35 and 40 kg / m2 associated to at least a comorbidity susceptible to be improved after the surgery
* Subject in failure of a medical treatment, led by an expert in nutrition, associating a dietary coverage and a physical activity adapted for at least 6 months
* Subject without contraindication for 3 studied surgical techniques
* Subject without cardiovascular events 6 months ago
* subject is informed and is consented
* Subject having a biologic balance dating less than 3 months

Exclusion Criteria:

* subject with contraindication for 3 studied surgical techniques
* women pregnant
* subject did not consent and is not informed
Omiganan Twice a Day (BID) in Patients With Facial Seborrheic Dermatitis

To explore the efficacy and pharmacodynamic effects of omiganan topical gel in facial seborrheic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with mild to moderate facial SD (IGA 2 or 3), ≥18 years of age, inclusive. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than SD following a detailed medical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, virology and urinalysis;
* Confirmed SD diagnosis by dermatologist
* Significant facial SD affected area as judged by the investigator or medically qualified designee
* Able to participate and willing to give written informed consent and to comply with the study restrictions;
* Willing to refrain from using other SD treatments in the local treatment area
* Subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose.

Exclusion Criteria:

* Any current and / or recurrent clinical significant skin condition other than SD;
* Ongoing use of prohibited SD medication. Washout periods prior to baseline are as follows;

  1. Topical steroids, antibiotics, antifungals or other topical (OTC) therapies: 2 weeks
  2. Systemic steroids, antibiotics, antifungals or other systemic therapies: 4 weeks;
  3. Phototherapy: 3 weeks;
  4. Regular use of shampoo for the treatment of PC (including but not limited to OTC zinc pyrithione shampoo), soap for the treatment of seborrheic dermatitis: 2 weeks
  5. Changing a soap, method for daily facial and hair washing: 1 week
* Known hypersensitivity to the compounds or excipients of the compounds;
* Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment;
* Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding;
* Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times in the past year;
* Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.
Stellate Ganglion Blockade in Corona Virus 2019 (COVID-19) Positive Patients

This study will establish the safety and efficacy of using stellate ganglion blocks in patients with acute respiratory distress syndrome (ARDS) due to COVID-19 disease.

The stellate ganglion block (SGB) will be performed in the ICU. Nurse will provide patient monitoring and assistance during the procedure. Standard monitors and advanced cardiovascular life support (ACLS) resuscitative equipment will be immediately available. A norepinephrine solution will be at bedside to treat potential hypotension associated with SGB. The SGB perineural catheter will be placed using standard sterile technique. Initial perineural bolus injection - clonidine 100 mcg, Decadron sodium phosphate (PF) 5mg, and 0.25% bupivacaine 5 ml is delivered. An ONQ brand perineural infusion 0.2% bupivacaine will be initiated at 2ml/hr for 5 days. Acute pain service will discontinue infusion and remove the catheter after 5 days.

Eligibility Criteria:
Inclusion Criteria:

* Any patient between the ages of 19-85 with laboratory established COVID-19 infection via Real-Time Reverse Transcription-Polymerase Chain Reaction (rRT-PCR) requiring critical care in an intensive care unit.
* Signs or symptoms consistent with ARDS must be present.
* The syndrome must present acutely, ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FIO2) ≤ 200 mm Hg, bilateral infiltrates on chest radiograph or CT not due to cardiac failure, need for non-invasive or invasive mechanical ventilation, and any cardiac dysrhythmia (excluding sinus tachycardia).

Exclusion Criteria:

* Hemodynamic instability (\>2 vasopressors)
* pre-hospital diagnosis of heart failure or fluid overload
* anatomical inability to perform block
* prior sympathectomy
* patient currently enrolled in another clinical trial for COVID-19 or respiratory distress/acute respiratory distress syndrome (ARDS)
* uncorrectable coagulopathy, already on Extracorporeal membrane oxygenation (ECMO), already on Nitric Oxide, pre-existing multi-organ failure (\>2 organ systems).
Orphan Drugs for Inherited Metabolic Diseases

The aim of this study is to report and describe all the patients with confirmed diagnosis of inherited metabolic disease (IMD) treated with orphan medicinal products (OMPs) in a cohort of adult patients followed in a reference center for rare diseases (Lausanne University Hospital, CHUV) from 2017-2022.

The development of novel therapies for inherited metabolic diseases, considered has OMPs, has improved the care of these patients. OMPs include a wide range of therapies from dietary products, enzyme replacement, substrate inhibitors, coenzyme replacement to more recently, gene therapy. Despite an increasing use of these therapies, they are still considered highly specialized treatments for very small groups of patients and share the characteristic of aiming to treat small populations with targeted therapies, which leads to higher costs and difficulties in obtaining clinical evidence. Drugs are approved for marketing and orphan designation by medical agencies based on their efficacy and safety.

In Switzerland, a separate country-specific process decides whether an approved drug is reimbursed. Because of the growing number of expensive OMPs, their reimbursement through public health insurances is increasingly manifesting itself as a moral dilemma for decision-makers. It may take a median of several years after submission of the first application by a pharmaceutical company for an orphan drug to become available to patients.

Considering the increasing number of OMP approvals and the still ethical challenge concerning their reimbursement, this study aims to share the experience of a single center in treating adult IMDs with OMPs but also in implementing novel therapies for rare diseases not yet covered by health insurers in Switzerland.

A database was created in 2017 including all patients with IMD followed at the Adult Metabolic Clinic in the CHUV. This database was part of a protocol submitted and approved by the Ethics committee (# 2017-02328). The results of this first analysis were published in the Journal of Orphan Rare Diseases. Investigators will use this database to identify all the patients treated with OMPs. Electronic and paper patient charts from the Division of Genetic Medicine will be reviewed for type of IMD and treatment. All variables will be entered in an excel database.

Eligibility Criteria:
Inclusion Criteria:

* Age = or \> 16 years
* Biological and/or genetically confirmed diagnosis of IMD

Exclusion Criteria:

* Age \< 16 years
* Document attesting refusal to participate