cyrilzakka/clinical-trials huggingface dataset:
Sudden Cardiac Death - Screening Of Risk Factors

The investigators have created a way of quickly collecting information in a large scale young population regarding the presence of some severity indicators that may allow us to classify them into: seemingly "low risk" and possible "elevated risk" for the presence of heart disease. It would have to be a short questionnaire, in order to receive a great adherence but that could simultaneously provide precise information, with an adequate description of symptoms and warning signs, in a way that a triage in the young adult population could be performed in the general young adult population in order to select individuals with an indication for personalized clinical evaluation and possible need of complementary diagnostic means. Based on this premise the investigators have developed a fast-response questionnaire named the Sudden Cardiac Death Screening Of risk factorS (SCD-SOS). This questionnaire has already been tested in a population of approximately 1500 young adults, and some changes have been introduced in order to refine its performance.

To best of the investigators knowledge, there are no large scale European surveys estimating the prevalence of cardiac disease and associated clinical symptoms in a non-selected (non-athlete) population of this age group.

Purpose: To screen a young adult population from central regional of Portugal for heart disease possibly associated to a high risk of Sudden Cardiac Death (SCD).

To determine the national prevalence of clinical symptoms of heart disease and of heart disease with increased risk for SCD in this age group.

To detect young adults in risk of SCD and with an indication for evaluation by a cardiologist, and possible need of:

* medical treatment
* electrophysiologic (EP) study and percutaneous ablation
* an implantable cardiovertor defibrillator
* a pacemaker
* other type of specialized cardiac intervention


Eligibility Criteria:
Inclusion Criteria:

* 12 to 40 years of age
* Providing an informed consent

Exclusion Criteria:

* Failure to meet any of the aforementioned inclusion criteria
Comparison of Magnetic Resonance Techniques for the Measurement of Cerebral Blood Perfusion

In this project, we aim at implementing a te-ASL sequence and to compare it to two reference ASL sequences with a fixed PLD on healthy individuals. On the one hand, the te-ASL sequence will be compared against a 3D pCASL with a PLD of 1800 ms, as the current reference according the Consensus of the ISMRM perfusion study group and the European consortium for ASL in dementia. On the other, as the implemented te-ASL sequence will have a 2D readout, it will also be compared to a 2D pCASL ASL sequence with the same PLD, in order to be able to disentangle differences due to the dynamic PLD scheme from those arising from the different read-out schemes.


Eligibility Criteria:
Inclusion Criteria:

* To sign the study informed consent form approved by the corresponding authorities.
* Healthy men and women (older than 18 years old).

Exclusion Criteria:

* Inability or unwillingness to give written informed consent or communicate with the study staff or illiteracy.
* Any contraindication to perform brain MRI procedure (e.g. pacemaker, MRI-incompatible aneurysm clips).
Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma

This was a randomized, controlled, open-label, Phase 3 multicenter study which enrolled patients with Relapsed-Refractory Multiple Myeloma (RRMM) who were either double refractory to an Immunomodulatory Drug (IMiD) and a Proteasome Inhibitor (PI) (regardless of the number of prior lines of therapy), or had received at least 3 prior lines of therapy including an IMiD and a PI.

Patients received treatment with melflufen+dexamethasone+daratumumab or daratumumab until documented progressive disease, unacceptable toxicity, or patient/treating physician decision. Patients in the daratumumab treatment arm had the option to receive treatment with melflufen+dexamethasone+daratumumab after confirmed progressive disease.


Eligibility Criteria:
Inclusion Criteria:

* A prior diagnosis of multiple myeloma with documented disease progression after the last line of therapy
* Double refractory to an IMiD and a PI (regardless of the number of prior lines of therapy) or have received at least 3 prior lines of therapy including an IMiD and a PI
* Prior treatment with daratumumab or another anti-CD38 antibody may be allowed under certain circumstances:

  * Achieved at least partial response (PR) and not refractory to an anti-CD38 antibody
  * At least 6 months since the last dose of anti-CD38 antibody
  * Not discontinued anti-CD38 antibody treatment due to related Grade ≥ 3 toxicity
* Male and female of childbearing potential agree to use contraception during the treatment period and at least 3 months after the last dose

Exclusion Criteria:

* Primary refractory disease (i.e., never responded with at least Minimal Response to any prior therapy for multiple myeloma)
* Prior treatment with CD38 CAR-T cell therapy or CD38/CD3 bispecific antibodies
* Any medical condition that may interfere with safety or participation in this study
* Other malignancy diagnosed or requiring treatment within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast, or very low and low-risk prostate cancer in active surveillance
* Known or suspected amyloidosis, plasma cell leukemia, or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
* Known central nervous system (CNS) or meningeal involvement of myeloma
* Prior stem cell transplant (autologous and/or allogenic) within 6 months of initiation of therapy or prior allogeneic stem cell transplantation with active graft-versus-host-disease
* Prior treatment with melflufen
SURGICAL GUIDES EFFECTIVENESS

The use of zygomatic implants is a technique that is becoming more and more widespread in daily clinical practice, however, few professionals feel safe and confident in performing this type of procedure. We therefore believe that a line of research focused on simplifying this technique will have an extraordinary impact on the safety of both patients and surgeons. Currently, new surgical guides have emerged that guarantee greater precision in the placement of zygomatic implants. However, no comparative clinical studies have yet been performed to evaluate the degree of accuracy of guided implant placement compared to the conventional freehand technique.

The primary objective of the study is to study the accuracy of the use of guided surgical splints compared to traditional freehand zygomatic implant placement.

The secondary objectives are:

* To compare the magnitude of variations depending on implant length by superimposing postoperative CT scans using 3DSlicer® (http://www.slicer.org) and exocad® software.
* To compare the magnitude of the variations depending on the location of the implant by superimposing postoperative and postoperative CT scans using 3DSlicer® (http://www.slicer.org) and exocad® software.
* To assess the clinical relevance of cogomatic implant placement using guided surgical splinting on pain parameters and surgical time.

Eligibility Criteria:
Inclusion Criteria:

• Age between 18-80 years of age, patients who sign the informed consent form and patients who consent to undergo preoperative and postoperative orthopantomography and CT scans.

Exclusion Criteria:

* Smoking (more than 10 cigarettes per day).
* Alcoholism (more than 25g/day in women and more than 40g/day in men according to WHO criteria),
* Oncological treatment (history of treatment in the last 6 months or current treatment with chemotherapy or radiotherapy).
* History of head and neck radiotherapy.
* Allergic to anesthetics or antibiotics.
Effect Evaluation of a Workplace Intervention Targeting Subjective Health Complaints

Mental disorders is one of the most frequent causes of long-term sick leave and disability pensions in Norway, and there is a need for a comprehensive, coordinated response from health and social sectors at the country level to address the burden of mental disorders. The aim of this project is to investigate if a workplace intervention with the aim to increase coping of common mental health complaints and social support can reduce sick leave and improve health.

The atWork intervention was established in 2007 as a new stepped-care approach to musculoskeletal complaints. The intervention consisted of workplace information meetings about musculoskeletal complaint to all employees and peer support. The atWork intervention targeting musculoskeletal complaints reduced sick leave and improved health in a randomized controlled trial. The atWork intervention has now been further developed with the aim to increase effect on sick leave and health. The intervention is now extended to include information about mental health complaints, in addition to a management course. The major societal costs and the negative consequences common mental health complaints induce underline the importance of testing if atWork is an effective way of reducing these consequences.

Eligibility Criteria:
Inclusion Criteria:

* Norwegian primary education unit.
* Participants must be employed in one of the Norwegian primary education units participating in the study.
* Participants must have sufficient Norwegian reading and writing skills.

Exclusion Criteria:

* The organization has received the atWork intervention at an earlier time.
* Participants are not employed in one of the participating organizations.
* Participants do not have sufficient Norwegian reading and writing skills.
The (Cost-) Effectiveness of Paediatric Laparoscopic Hernia Repair Compared to Open Hernia Repair

This study assess the (cost-)effectiveness of open versus laparoscopic Percutaneous Inguinal Ring Suturing (PIRS) technique for unilateral inguinal hernia repair in children aged 0-16 years.

Research question Inguinal hernia repair is one of the most common operations in children. After open unilateral inguinal hernia repair, 6-8% of patients develops an inguinal hernia on the contralateral side. Laparoscopic inguinal hernia offers the opportunity to inspect the contralateral groin and repair an asymptomatic contralateral hernia, if present.

Main question: What is the most (cost-)effective treatment strategy for unilateral inguinal hernia repair in children aged 0-16 years: the open or laparoscopic Percutaneous Inguinal Ring Suturing (PIRS) technique?

Hypothesis The optimal treatment for children with an inguinal hernia is laparoscopic hernia repair, since the surgeon can inspect and possibly, repair, the contralateral groin. Laparoscopic inguinal hernia repair results in less operations and exposure to anaesthesia, less hospital admissions, lower costs and a better quality of life compared to open inguinal hernia repair.

Study design Multicentre randomized controlled trial.

Study population Children aged 0 - 16 years with a unilateral inguinal hernia.

Intervention Inguinal hernia repair with the laparoscopic PIRS technique.

Usual care/comparison Inguinal hernia repair with the open technique.

Outcome Measures Primary: Number of operations related to inguinal hernia repair and cost-effectiveness (social and healthcare related costs). Secondary: complications, total duration of surgery (including anaesthesia and total duration of operating room time), post-operative pain, length of hospital stay, time to normal daily activities, cosmetic appearance, health-related quality of life. All outcome measures will be assessed within two years after the primary inguinal hernia correction.

Sample size/data analysis 464 patients (power of 0.80, alpha 0.05). Cost-effectiveness analysis/budget impact analysis The economic evaluation will be assessed from a societal and health care perspective. Cost-effectiveness will be assessed in terms of QALYs and the primary and secondary outcomes. A budget impact analysis will be conducted using the "Budget Impact Analyse - leidraad en rekentool" of ZonMw. Missing data will be imputed.

Eligibility Criteria:
Inclusion Criteria:

1. Infants aged 0 months to 16 years of age with a primary unilateral inguinal hernia undergoing hernia repair

Exclusion Criteria:

1. incarcerated inguinal hernia, which have to be operated immediately,
2. recurrent hernia
3. ventricular-peritoneal drain
4. non-descended testis
5. parents who are not able to understand the nature or consequences of the study.
Optimal Dosing of Preoperative Gabapentin for Prevention of Postoperative Nausea and Vomiting

Overall incidence of postoperative nausea and vomiting (PONV) after general anesthesia is 40-90 % . gabapentin has been incorporated into "fast-track" packages and improved recovery during surgery protocols to avoid unintended side effects associated with opioid alternatives. Interestingly, gabapentin has also been noted to reduce the effects of chemotherapy-induced nausea, effective in treatment of gravidarum hyperemesis, and postdural puncture emesis. Different dosing regimens were tested.The goal of the study is to determine the most effective dose of oral gabapentin given 1 hour prior to surgery on the occurrence and severity of PONV and drug side effects in the first 24 hours postoperatively to find the most effective dose of gabapentin with the least side effects.

A total of (150) adult patients who will undergo elective abdominal laparoscopic surgery will be included in the study. Written informed consent will be obtained from all patients before randomization. Randomization will be done with the help of a computer generated list of numbers. Patients will be divided randomly and equally into three groups (50 patients each(. The first group of patients will receive 300 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water (group G1), the second group of patients will receive 600 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water (group G2), the third group of patients will receive 900 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water (group G3). Drug formulation will be done by one of the researchers making the dosage of the three groups the same in number and shape of the capsules and then given to a junior anesthetist who is neither involved nor interested in any way in the sample to be administered to the patients surveyed

Eligibility Criteria:
Inclusion Criteria:

* age between (18- 65) years
* ASA I-II
* scheduled for elective laparoscopic abdominal surgery.

Exclusion Criteria:

* age below 18 and above 60 years
* ASA III- IV
* pregnancy or breastfeeding
* psychiatric illness
* administration of antiemetic or systemic corticosteroids within 24 hours prior to surgery
* vomiting within 24 hours prior to surgery
* alcohol or drug abuse;
* known hypersensitivity or contraindications to gabapentin
* impaired liver or kidney function
* history of motion sickness
* patients on anti-depressants
* patients on whom laparoscopic procedure converted into open technique.
SPOON: Sustained Program for Improving Nutrition - Colombia

The primary goal of this study is to prevent undernutrition and obesity in peri-urban areas of Colombia. This study is designed to evaluate the impact of promoting adequate feeding practices and the use of SQ-LNS (Small Quantity Lipid-Based Nutrient Supplements) on the nutritional status of infants and young children. The study will be conducted in peri-urban areas of Pasto, Colombia in conjunction with Fundación Saldarriaga Concha and the Colombian Ministry of Health and Social Protection.

SPOON Colombia is an innovative strategy to prevent undernutrition and obesity in children aged 0-24 months living in high-poverty areas of Colombia. The SPOON program aims to improve infant and young children feeding practices, including exclusive breastfeeding during a child's first six months and home-fortification with peanut-based SQ-LNS (small quantity lipid-based nutrient supplements) for children 6 to 24 months of age.

The SPOON intervention will randomly assign participants at the household level to one of three groups: a control group, Treatment Group 1, and Treatment Group 2. Participants in the control group will receive the standard services provided by their local health clinics in addition to a supply of micronutrient powder. The powder consists of vitamins and minerals that are added to the child's food to increase his or her consumption of micronutrients. Participants in Treatment Group 1 will receive group counseling and the SQ-LNS supplement instead of micronutrient powder. The group counseling program consists of various lessons for the children's caregivers about the importance of breastfeeding and providing high quality food with the SQ-LNS supplement. Those assigned to Treatment Group 2 will receive all the services that those in Treatment Group 1 receive in addition to individualized counseling, where messages about nutrition and breastfeeding will be reinforced through home visits.

Comparing the three treatment arms will identify the marginal impact of the SPOON program. For example, measuring the differences in outcomes between the participants in the control arm and in Treatment Group 1 will identify the impact of the Spoon program package, which includes SQ-LNS and group counseling, compared to current government-provided services. Measuring the differences between Treatment Group 1 and Treatment Group 2 will indicate the marginal impact of individualized counseling, and measuring the difference between the control arm and Treatment Group 2 will determine the combined impact of the SPOON program combined with individualized counseling.

Eligibility Criteria:
Inclusion Criteria:

* Participants must live in the defined intervention areas

Exclusion Criteria:

* Any chronic disease or malformation
* Caretakers of the children plan on moving in the next 24 months
The Heart Hive - Cardiomyopathy Study

This is an online registry and database of patients with cardiomyopathy and myocarditis, coupled with an observational study of DCM and HCM.

This study utilises The Heart Hive, an international, online registry of patients with self-reported clinically diagnosed cardiomyopathy or myocarditis, and people with a family history of cardiomyopathy, enrolled on an on-going basis. Registry participants are invited to enter self-reported demographics and health data relevant to their cardiac diagnosis into The Heart Hive online database.

Registry participants with self-reported clinically diagnosed dilated (DCM )or hypertrophic (HCM) cardiomyopathy will be recruited to an observational, prospective study entailing collection of patient-reported baseline demographic data and clinical risk factors, genotyping, and annual collection of follow up data from patients, national registries (NHS Digital) and medical records.

In the pilot phase 100 DCM and 100 HCM patients will be recruited to a validation study. Consent will be sought to access medical information from health care providers in order to compare against and confirm self-reported health information. DNA will be obtained from saliva samples and tested in-house using a panel of clinically validated known Mendelian DCM and HCM genes as a second validation of the accuracy of self-reported diagnosis and to confirm equivalent genetic architecture of DCM and HCM in direct-to-patient recruited cohorts compared to traditional centre of excellence clinic-based recruitments.

Following validation of the approach and once funding is in place for genomic studies, larger numbers of affected DCM and HCM patients will be recruited to this study from the registry of research willing participants.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age 18 and over),
* Males and Females,
* Capacity to provide informed consent,
* Patients with a confirmed diagnosis of cardiomyopathy or myocarditis,
* People with a family history of cardiomyopathy confirmed in a first or second degree relative.

Note: Pregnant women are eligible. This study is observational and entirely separate from clinical care.

Exclusion criteria:

* Patients who lack capacity to consent for themselves,
* Vulnerable groups (e.g. those under 18, prisoners, those in a dependent relationship, the mentally ill).
* Patients with a confirmed history of coronary artery disease:
* who have been informed by their treating physician that their cardiomyopathy is secondary to their coronary artery disease, or
* who have undergone previous percutaneous coronary intervention or coronary bypass surgery
* History of primary valvular heart disease or congenital heart disease
* Severe, untreated or untreatable hypertension (systolic blood pressures routinely \>180 mm Hg and/or diastolic blood pressures \>120 mm Hg)
A Study on Spermatogenesis in Male Renal Transplant Recipients Receiving Valganciclovir (Valcyte®) Versus Untreated Matched Controls

This observational study will compare spermatogenesis in male adult renal transplant recipients receiving valganciclovir versus untreated matched controls. Data will be collected from each participant for up to 52 weeks post transplant.


Eligibility Criteria:
Inclusion Criteria:

* First renal transplant
* Participant eligible to receive valganciclovir prophylaxis as determined by the treating physician in accordance with the local approved product prescribing information (Cohort A only) or the participant is not expected to require any valganciclovir prophylaxis (Cohort B only) post-transplant
* Participant has no history of known infertility
* Participant is able and willing to provide semen samples
* Participant agrees to utilize a barrier contraceptive throughout the study or for at least 90 days after cessation of valganciclovir treatment

Exclusion Criteria:

* Prior ganciclovir or valganciclovir within 3 months of enrollment
* Organ transplant other than kidney
* Participant has received an investigational new drug in the 3 months prior to transplant
* Participant hs received an alkylating agent or other medications known to affect fertility/spermatogenesis
* Participant is unlikely to be available for follow-up for the entire duration of the study (up to 52 weeks)