cyrilzakka/clinical-trials huggingface dataset:
Vascular Fingerprint Validation Study

The vascular fingerprint is a simple selection tool to identify testicular cancer patients with a high risk of arterial cardiovascular events during and in the first year after cisplatin chemotherapy. Eventually, this selection method allows a relative small randomized intervention study with i.e. LMWH during chemotherapy to prove the effectiveness and safety in lowering the chance of an arterial cardiovascular event.

Since the introduction of cisplatin in the late seventies (1), the prognosis of metastatic testicular cancer patients has dramatically improved, with long-term survival rates of 80-90% (2). However, cure rates are compromised by the increased risk of cardiovascular events (3-5). Approximately 1-5% of the patients with metastatic testicular cancer develop arterial cardiovascular events during or shortly after cisplatin- and bleomycin containing chemotherapy (3-7). Arterial cardiovascular events include ischemic stroke and myocardial infarction. These arterial events are a source of serious treatment-induced morbidity and mortality as recently clearly confirmed by Fung (8). No established standard prophylaxis is available. There is an unmet need to have the possibility to identify high risk patients before start of chemotherapy in whom prophylactic anti-coagulant treatment may prevent events (9). An identification tool could maximize the benefit of an intervention without introducing too much unnecessary harm: preventive interventions also carry risk.

Recent data from the investigators' cancer center showed that before chemotherapy 22% of the metastatic cancer patients had ≥3 of the following 5 traditional cardiovascular risk factors present (high risk vascular fingerprint, figure 1): overweight, smoking, hypertension, dyslipidemia and impaired blood glucose. These patients had an increased risk to develop arterial events during or early after chemotherapy: 19% of the patients with a high risk vascular fingerprint developed an arterial cardiovascular event whereas only 2% of the patients with ≤2 risk factors developed an event . The vascular fingerprint seems an easy method to identify which metastatic testicular cancer patients are at a high risk for early arterial events and who may benefit from prophylaxis with for example low molecular weight heparins (LMWHs). To be used in the clinic these data need to be confirmed in an independent cohort.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of metastatic TC and an indication to start with first-line cisplatin-based chemotherapy for metastatic TC
2. Classified into IGCCCG good or intermediate prognosis group
3. Younger than 50 years of age at start of chemotherapy
4. Signed informed consent

Exclusion Criteria:

1. History of previous cardiovascular disease
2. Retroperitoneal mass \> 5 cm
3. Indication for anticoagulant therapy at start of chemotherapy
Effects of Micro-dose and Low-dose Recombinant Human Erythropoietin on Mitochondrial Function and Cognitive Performance

A recent study by Plenge et al. revealed that rhEpo treatment enhances skeletal muscle mitochondrial respiratory capacity in humans indicating a muscle ergogenic effect of rhEpo on aerobic metabolism. The main purpose of the present study is to determine if a shorter treatment period with micro-dose as well as low-dose rhEpo has similar effects on muscle mitochondrial function.

Higher doses of rhEpo is known to increase cognitive performance, but it is not clear if lower doses of rhEpo have similar effects. A second purpose of the present study is to determine if micro-dose as well as low-dose rhEpo increases cognitive performance.

Twenty-five healthy young male volunteers are randomized to either a low-dose rhEpo (60 IU/kg/week), micro-dose rhEpo (20 IU/kg/week), or placebo control (saline) group. All subjects receive two subcutaneous injections per week for four weeks. Muscle biopsies are taken at the beginning and end of the study period. Mitochondrial function is measured in permeabilized fibres using high-resolution respirometry with the substrates malate (2mM), octanoyl carnitine (1.5mM), glutamate (10mM), succinate (10mM), under saturating \[ADP\] (5mM), and with the membrane uncoupler FCCP (1μM).

On the first day before administration of rhEpo and after the four weeks' treatment the subjects are undergoing two cognitive performance-tests, Raven Standard Progressive Matrices (Raven), and Number Finder (NUFI). Weekly semi-structured interviews are conducted by a blinded interviewer focusing on experienced change in cognitive performance.

Eligibility Criteria:
Inclusion Criteria:

* Normal medical examination
* Weekly exercise for 0-5 hours

Exclusion Criteria:

* Smoking daily
* Earlier use of performance-enhancing drugs
* Elite athletes
* Presence of cardiovascular or metabolic disease
A Prospective Study of The Complement Depletion in Patients With Severe Abdominal Sepsis

The role of complement system in bridging innate and adaptive immunity has been confirmed in various invasive pathogens. The aim of this study is to investigate the alteration of complement C3 in patients with severe abdominal sepsis and evaluate the role of complement C3 depletion in prognosis of such patients. The relationship between complement C3 depletion and adaptive immunity is studied meanwhile.

Severe abdominal sepsis remains a significant cause of death in patients undergoing intra-abdominal infection, in despite of recent declines in overall mortality. There is a abundant evidence to suggest complement activation during sepsis. While there is great interest in complement by-products in human sepsis, few studies focus on the persistent consumption of complement components and its role in prognosis of sepsis. Complement C3 is indispensable community pathway for complement activation. In a way, the alteration of C3 levels can affect the whole status of complement biological functions.

In clinical practice, the severe abdominal sepsis would develop compromised immune function if the intra-abdominal infection is not well controlled. The down-regulated T- and B-cell immune responses to sepsis are correlated to the decreased immune defense. To our knowledge, there are few human data that have investigated the relationship between complement depletion and adaptive immunity in severe abdominal sepsis. The investigators hypothesize that the complement C3 depletion during sepsis has a stronger association with the down-regulated adaptive immunity and can be regarded as a essential risk factor to predict the prognosis of such critical illness.

The purpose of this prospective study is two-fold. First, the investigators observe, in a cohort of patients with severe abdominal sepsis, the levels of complement components and percentages of T cell subsets after admission to evaluate the relationship between complement system and adaptive immunity. Second, the investigators also evaluate the application of the C3 related-indexes (C3, C3a, Factor H, DAF, etc.) to patients undergoing severe abdominal sepsis and to develop an alternative model to predict its prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of severe abdominal sepsis

Exclusion Criteria:

* Age \< 18 or \> 60 years
* Pregnancy
* Leucopenia from radiochemical therapy due to malignant tumor
* Any primary diagnosis other than sepsis
* Confirmed immunodeficiency
* Requirement for blood transfusion, plasmapheresis, or immediate surgery
Sense of Security With Access to Palliative Outpatient Clinic

The aim of the study is to evaluate experience of security, accessibility, and avoidable utilization of health care services in patients who have had access to specialized palliative care clinic (SPCC) compared to those who have not, and to evaluate the relatives' experience of the care.

Palliative care aims to improve the quality of life for patients and families who are affected life-threatening, incurable disease. The concept of palliative care has changed over time and is not longer reserved for patients in the dying phase. More, and more studies show that early integration of palliative care and disease-specific care give positive results. Specifically, palliative care is about prevent and alleviate suffering by early detection of symptoms and treatment of physical, psychological, social and existential problems. In order to provide the best care, a holistic approach is required that takes up what is important right now for the patient, and not focus on only the diagnoses. The care should be person-centred, but it is not entirely clear how this is best achieved.

In an initiative for person-centered care, Palliative care and ASIH, Region Skåne, was the first region in the Sweden to established a new form of care; 'Palliative specialist outpatient clinic' (which was done in 2021). This initiative is a way to support patients who are still receiving disease-specific treatment at their home clinic, which are not specialized in the palliative care needs that may arise. At the same time, the patients do not have that great care needs that they need to be enrolled in specialized palliative care 24/7.

Patients are invited to the study in connection with enrollment at ASiH. All patients who are referred from Palliative specialist reception are consecutively asked about participation in the study. For each patient who previously had contact with the Palliative Specialist Clinic, a patient referred directly from disease-specific care/primary care will be included as to the control group.

Data collection will take place through a self-developed questionnaire where the patient is asked about his experience of security and accessibility in the last 3 months before enrollment in ASiH. Survey questions about safety and accessibility have been chosen as far as possible from among validated questionnaires. If the patient agrees, relatives will also be invited to answer a similar questionnaire. Data on health care consumption, diagnoses and symptoms are collected through Region Skåne's Vårddatabaser and journal review.

Eligibility Criteria:
Inclusion Criteria:

- Patients admitted to included ASiH-unit

Exclusion Criteria:

* Patients with cognitive impairment
* Patients who cannot fill in a questionnaire in Swedish, Arabic or Serbo-Croatian.
Targeted Intraoperative Therapy Registry at Bethesda North Hospital (TARGIT)

The purpose of this study is to create a registry to evaluate the use of intra-operative radiation therapy (IORT) and to study the efficacy and toxicity of breast radiotherapy given intra-operatively as a single fraction after breast conserving surgery,

A registry trial has been designed and modeled after the original successful TARGIT protocol, to continue the use of IORT for a select population of women, and to follow outcomes with regards to local and regional control, toxicity and morbidity. Patients selected for breast conserving surgery, who are considered to have a low risk of local recurrence, are eligible for this registry trial once their informed consent is obtained. This single arm cohort study allows entry of patients who have been diagnosed with early stage breast cancer and whose clinical stage is suitable for treating conservatively (small tumor and no gross nodal involvement). Tumors should not be more than 3.5 cm in size.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 45 or greater
* Diagnosed with operable invasive breast cancer, T1 and T2 (\< 3.5 cm), N0, M0, confirmed by cytological or histological examination
* Suited for breast conserving surgery
* Have had an ipsilateral (same side as current cancer) diagnostic mammogram within 12 months of enrollment

Exclusion Criteria:

* age 44 or less
* Axillary lymph node positive breast cancer
* Invasive lobular cancer
* Tumor size \> 3.5 cm
* Extensive Intraductal Component (EIC= \> 25% of the lumpectomy specimen involved with ductal carcinoma in situ, DCIS) as assessed on surgical pathologic lumpectomy specimen
* Multicentric cancer in the same breast not amenable to excision with a single lumpectomy
* Inability to assess pathologic margin status
* Synchronous bilateral breast cancer at the time of diagnosis.
* Ipsilateral breast had a previous cancer and/or prior in-field radiation.
* Patients known to have BRCA1/2 gene mutations
* Neoadjuvant treatment (hormones or chemotherapy)
Impact of Chair Seat Height on the 1-Minute Sit to Stand Test Performance in Chronic Obstructive Pulmonary Disease

The 1-minute sit to stand (1-min STS) test is a standardized test which is used to examine exercise capacity in patients with chronic obstructive pulmonary disease (COPD). The chair seat height used is standardized to 46-48 cm. Using a standard seat height for all patients - irrespective of their body height - may lead to invalid estimates of functional exercise capacity. The objective of this study is to assess whether there is a difference in repetitions during the 1-min STS test if the seat height is adjusted to 90° knee joint angle or the standard height chair of 46 cm is used.

In a single-center, randomized crossover study, the investigators aim to elucidate whether there is a difference in repetitions during the 1-min STS test if the seat height is adjusted to 90° knee joint angle or the standard height chair of 46 cm is used.

Patients with COPD referred for pulmonary rehabilitation will be invited to perform one standardised- (chair seat height 46cm) and one individualized (chair seat height adapted to 90° knee flexion) 1-min STS test on two different days in random order.

The tests will be performed after patients are familiarised with the 1-min STS testing procedure and learning effects can be excluded.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosed COPD according to a forced expiratory volume in 1s (FEV1) / forced vital capacity (FVC) ratio below the lower limit of normal

Exclusion Criteria:

* Patients who are not able to bend their knees while sitting on a standard chair (i.e., knee flexion less than 90°)
* Patients who are not able to understand the instructions of the 1-min STS test, either of language or cognitive reasons
* Patients who are unable to perform the STS test due to functional disability (i.e., being not able to rise from a chair without hand support), previous surgery, or pain according to the judgement of the responsible physician.
* Patients who did not sign the informed consent form
Savolitinib vs. Sunitinib in MET-driven PRCC.

This study is designed for patients diagnosed with MET-driven, unresectable and locally advanced or metastatic Papillary Renal Cell Carcinoma. The purpose of this study is to see if an investigational new anti-cancer medication, savolitinib, is effective in treating patients with MET-driven PRCC, how it compares with another medication frequently used to treat this disease called sunitinib, and what side effects it might cause.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed PRCC, which is unresectable/locally advanced or metastatic with measurable disease as per RECIST 1.1. Patients with papillary urothelial carcinoma or renal pelvis cancer of the kidney are not considered PRCC and are not eligible.
2. Confirmation of MET-driven PRCC without co-occurring FH or VHL mutations from an FFPE tumour sample using the sponsor-designated central laboratory validated NGS assay
3. Patients who have received no prior systemic therapy as well as those who have received prior systemic therapy for PRCC in the advanced setting.\* Patients can be treatment-naïve, or previously treated, but cannot have previously received sunitinib or a MET inhibitor. Patients who have received prior systemic therapy must have had disease progression in soft tissue disease or bone within 6 months of the last dose of the most recent systemic therapy
4. Adequate haematological, renal, cardiac and liver functions
5. Karnofsky performance status ≥ 80

Exclusion Criteria:

1. Most recent cytotoxic chemotherapy, immunotherapy, chemo-immunotherapy, or investigational agents \<28 days from the date of randomisation. Most recent non cytotoxic targeted therapy \<14 days from the date of randomisation.
2. Prior treatment with a MET inhibitor (e.g. foretinib, crizotinib, cabozantinib, onartuzumab or previous savolitinib) or sunitinb.
3. Treatment with strong inducers or inhibitors of CYP3A4 or strong inhibitors of CYP1A2, taken within 2 weeks or not possible to be stopped for at least 2 week before the date of randomisation. Herbal medications cannot be taken within 7 days of the date of randomisation (3 weeks for St John's wort).
4. Wide field radiotherapy administered ≤28 days or limited field radiation for palliation ≤7 days prior to the date of randomisation
5. Major surgical procedures ≤28 days of randomisation or minor surgical procedures ≤7 days. No waiting is required following port-a-cath placement.
6. Previously untreated brain metastases
7. Serious active infection or gastrointestinal disease
8. Presence of other active cancers, or history of treatment for invasive cancer within the last 5 years.
9. Mean resting QTcF \>470 msec for women and \>450 msec for men on the Part 2 screening triplicate ECGs or factors that may increase the risk of QTcF prolongation such as chronic hypokalaemia not correctable with supplements, congenital or familial long QT syndrome, or family history of unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes
The Evaluation of a Noninvasive Respiratory Monitor in Intubated Infants

In this research study, the investigators want to learn more about whether the Respiratory Volume Monitor (ExSpiron) can accurately measure breathing in infants less than 12 months of age. The Respiratory Volume Monitor uses up to 5 stickers that are placed on the chest to measure the amount of air going in and out of the lungs with each breath (Tidal Volume), the number of times per minute a breath is taken (Respiratory Rate), and the amount of air going in and out of the lungs per minute (Minute Ventilation).

It is important for medical staff to be able to collect information about breathing non-invasively because it may help determine if certain children are experiencing breathing problems sooner than the way it is currently detected.

The goal of this study is to determine if the Respiratory Volume Monitor works accurately in infants less than 12 months of age.


Eligibility Criteria:
Inclusion Criteria:

* less than 12 months of age
* currently intubated in the ICU

Exclusion Criteria:

* ExSpiron monitor will interfere with a healing surgical procedure site or standard of care
Virtual GERAS DANCE Feasibility RCT

GERAS DANcing for Cognition and Exercise (DANCE) is a therapeutic mind-body program for older adults (aged 60+) developed with rehabilitation and geriatric medicine expertise at the GERAS Centre for Aging Research at Hamilton Health Sciences and McMaster University. This study will examine if a virtual dance program is feasible for older adults and if dancing at home can benefit mind-body health, self-confidence, and mood.

GERAS DANCE fulfills an urgent need in our community to provide tailored evidence-based programming to help improve the health of older adults and was adapted for virtual implementation. This randomized controlled trial (RCT) aims to measure (1) the feasibility of virtual GERAS DANCE in older adults to inform a large full-scale study, and (2) the potential effects of virtual GERAS DANCE on mobility, balance self-efficacy, cognition, frailty, and mood in older adults. This study will utilize a single-center, prospective, parallel-group randomized controlled feasibility approach. This RCT will involve 48 older adults using a person-centered and coordinated model of care embedded into existing community health partnerships. Participants will be randomized to receive 6-weeks of virtual GERAS DANCE or usual care. All participants randomized to usual care will receive the dance intervention after study completion for equal opportunity to participate in the virtual GERAS DANCE program. The progressive GERAS DANCE curricula will be delivered virtually for 1-hr class twice weekly by a certified GERAS DANCE instructor. GERAS DANCE curricula include gradual increases in cognitive load and are based on motor learning principles of the ABCs of movement Agility, Balance, and Coordination. The ABCs of movement is essential to quickly and efficiently change the body position with balance and coordination. Assessments of mobility, balance self-efficacy, cognition, frailty, and mood will occur at baseline and 6-weeks.

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling adults aged ≥ 60 years of age;
* Has access, or has a caregiver who has access to a device at home that can support a videoconferencing service
* Able to ambulate independently with or without a walking aid; OR with caregiver supervision at home;
* Family physician's signature on a medical clearance form to ensure they are cleared to exercise safely.

Exclusion Criteria:

* Unable to speak or understand English and has no caregiver for translation;
* Significant cognitive impairment where they may have difficulty following two-step commands;
* Unstable angina or unstable heart failure;
* Travel plans that would result in missing greater than 20% of the trial's 6-week duration;
* Currently attending a group exercise program.
Telcagepant for Prevention of Menstrually Related Migraine in Female Participants With Episodic Migraine (MK-0974-065)

This is a multicenter study to test the hypothesis that telcagepant is superior to placebo in preventing perimenstrual migraines as measured by mean monthly headaches during the entire treatment period. This study will also evaluate the safety and tolerability of telcagepant for female migraine participants.


Eligibility Criteria:
Inclusion Criteria:

* Participant who has had regular menstrual cycles monthly (22 to 32 days) for at least the last 3 cycles
* Participant experiences headache during menstrual period in at least 2 out of last 3 cycles
* Participant has history of migraine for ≥ 3 months and with ≥ 2 migraine attacks per month in the 2 months prior to screening
* Participant agrees to use an effective method of birth control through the duration of the study

Exclusion Criteria:

* Participant has basilar or hemiplegic migraine headache
* Participant has taken medication for acute headache on more than 15 days per month in the 3 months prior to screening
* Participant is taking prophylactic medication for migraine and daily dose has changed within 4 weeks prior to screening
* Participant has history of significant liver disease
* Participant has had cardiac surgery or symptoms within 3 months of screening
* Participant has confounding pain syndromes, psychiatric conditions, dementia, or major neurological disorders other than migraine
* Participant has history of neoplastic disease ≤ 5 years prior to signing informed consent
* Participant has history of gastric or small intestinal surgery
* Participant consumes 3 or more alcoholic drinks per day
Low vs Standard Pneumoperitoneum Pressure During Single Port Access Laparoscopic for Adnexal Pathology

During laparoscopy pneumoperitoneum creates the necessary space in which to perform the operation. Growing evidence in general surgery has shown that reduction of intra-abdominal pressure during laparoscopy is related to improved postoperative outcomes, decreased pain perception, length of hospital stay, and analgesic rescue dosage in patients undergoing minimally invasive procedures using low pneumoperitoneum pressure (LPP) compared with standard pneumoperitoneum pressure (SPP). Aim of the study is to demonstrate the safety and feasibility of LPP during performance of Single Port Access Laparoscopy for benign adnexal pathologies.


Eligibility Criteria:
Inclusion Criteria:

* patients 18- 45 years old
* elective laparoscopic operation
* informed consent

Exclusion Criteria:

* BMI \> 30 kg/cm2
* pregnancy
* converting to laparotomy
* malignant disease
* unable or unwilling to give written consent