cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness of an Exergame-based Intervention

This randomized control trial aims to compare the effects of a regular exergame-based intervention and a regular moderate-intensity endurance exercise in healthy individuals. The main questions it aims to answer are:

• Is regular exergame-based training an effective intervention to improve different health and performance parameters in healthy adults? Can the exergaming intervention improve health and performance parameters similar to a moderate-intensity endurance exercise intervention? Throughout the intervention period (8 weeks), participants will participate in regular training sessions (3x/week) in an exergame called the ExerCube.

Researchers will compare the effects to a control group who participates in regular (3x/week) moderate-intensity endurance exercise to see if the exergaming intervention induces similar effects on health and performance parameters.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female and male adults
* Aged 18-60 years
* Free from acute and chronic diseases
* Free from movement restrictions or injuries to the musculoskeletal system
* Provided written informed consent

Exclusion Criteria:

* Underlying health condition that could compromise the safety of the physical exercise
* Were taking cardiovascular medications
Investigation With BiopH+Psoriasis Medical Bath in Subject With Mild to Moderate Plaque Psoriasis.

The purpose of this investigation is to assess performance and safety of BIOpH+ Psoriasis Medical Bath in comparison to a comparative device.

After being informed about the investigation and the potential risks, all subjects giving written informed consent will undergo screening to determine eligibility for study entry. At week 0, subjects who meet the eligibility requirements will be randomised in open, intra-patient investigation, treated with BIOpH+ Psoriasis Medical Bath on one side, and comparative treatment on the other side for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary agreed to participation and has duly signed Informed Consent Form
* Males and females ≥ 18 years of age
* In the Investigator's opinion, the patient is not likely to become pregnant during study participation (e.g. in a same-sex relationship, not sexually active, sterile, not of child-bearing age, uses contraception, etc.)
* Subject diagnosed with stable mild-moderate plaque psoriasis, defined by PASI ≤ 9
* Intra-individual difference between left and right hemi-body PASI scores not \> 1.0
* Patients with symmetrical psoriasis

Exclusion Criteria:

* Presence of other forms of psoriasis other than psoriasis vulgaris (palmoplantar psoriasis, inverse psoriasis, other forms of hyperkeratosis)
* Use of systemic/biological treatment for psoriasis
* Known hypersensitivity or allergy to study products
* Any serious medical condition that could interfere with the evaluation of study results
* Poor compliance in other investigational study, as assessed by investigator
* Pregnant, breastfeeding, or planning to become pregnant during study
* Patients with alcohol -or drug abuse
* Any other conditions as judged by the investigator may make the follow-up or investigation inappropriate
* Anyone unsuitable to participate as subject according to the Declaration of Helsinki
CArdiovascular Risk Assessment STudy in Lupus Erythemathodes (CASTLE)

The key of this prospective study is to identify a potentially increased cardiovascular risk in patients with systemic Lupus erythematodes, with and without renal affection. Three groups of patients will be compared.

Key of this prospective study is to identify a potentially increased cardiovascular risk in patients with systemic Lupus erythematodes, with and without renal affection. Three group of patients will be compared as followed. First group are patients with known systemic Lupus erythematodes without renal affection, second group are patients with known systemic Lupus erythematodes with renal affection and the third group are patients with a non-autoimmun chronic kidney disease

Eligibility Criteria:
Inclusion Criteria:

* Patients with systemic Lupus erythematosus

Exclusion Criteria:

* Patients without systemic Lupus erythematosus
Effect of Liraglutide on Glucagon Secretion in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to examine the effect of NNC 90-1170 on the hypoglycaemic counterregulation in subjects with type 2 diabetes.


Eligibility Criteria:
age: minimum 30, maximum 75 years
Effect of Everolimus on the Pharmacokinetics of Tacrolimus in Renal Transplant Patients

The purpose of this study is to understand the effects of everolimus on tacrolimus pharmacokinetics (pk) in patients receiving de novo kidney transplants.

Multidrug immunosuppression regimens have synergistic effects which allow the use of lower doses of individual agents. These regimens generally include calcineurin inhibitors (CNIs: cyclosporine or tacrolimus), mammalian target of rapamycin (mTOR) inhibitors (everolimus or sirolimus), and corticosteroids. CNIs and mTOR inhibitors are substrates for cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp); in addition, cyclosporine is a inhibitor of CYP3A4 and P-gp. Therefore, concomitant administration of those drugs may alter their serum levels.

It is remained to be evaluated whether the pharmacokinetics or clinical efficacy of tacrolimus will be affected when the regimens contain everolimus in clinical practice and the effect of ABCB1、CYP3A4、CYP3A5、POR genetic polymorphism on the two Drugs. Mycophenolate mofetil (MMF) has no effect on pharmacokinetics of tacrolimus; therefore, MMF is used as a control to understand the effects of everolimus on pharmacokinetics of tacrolimus in patients receiving de novo kidney transplants. The effect of ABCB1、CYP3A4、CYP3A5、POR genetic polymorphism on the two Drugs was also assessed.

Eligibility Criteria:
Inclusion criteria:

* De novo kidney transplants
* 20 - 65 years old
* aspartate aminotransferase/alanine aminotransferase within 2 times the upper limit of normal range

Exclusion criteria:

* Pregnancy
* Tuberculosis
* Hepatitis B or C carrier status
* Human immunodeficiency virus-positive status
* Retransplantation or multiorgan transplantation
* History of rheumatoid arthritis
* Use of drugs that might have enhanced or inhibited CYP3A4 or P-gp activity
Metadoxine as a Therapy for Severe Alcoholic Hepatitis

The purpose of this study is to determine whether metadoxine is effective for improve survival and reduced oxidative stress in patients with severe alcoholic hepatitis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical and biochemical criteria for severe alcoholic hepatitis: Total bilirubin greater than 5 mg/dl in absence of biliary tract obstruction evidenced by ultrasound, history of chronic alcohol intake, leukocytosis, neutrophilia, elevation of transaminases with an aspartate aminotransferase / alanine aminotransferase ratio equal or greater than 2, discriminant function greater than 32.

Exclusion Criteria:

* Diabetes, chronic kidney disease, hepatitis C, hepatitis B and or human immunodeficiency virus infection, asthma or history of atopy or allergic reactions, therapy in the previous two years with steroids, pentoxifylline, metadoxine, S-adenosyl L- methionine, antioxidants or multivitamins.
Validation of an ERAS Protocol in Gynecological Surgery

Validation of ERAS interventional measures in elective gynecological surgery, for benign either malignant pathology.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 and \<75 years old
* Patients candidated for elective gynecological surgery for benign pathology
* Patients with diagnosis of gynecological neoplasm and candidated for elective gynecological surgery
* Signed consent form
* Karnofsky Performance Status \> 70

Exclusion Criteria:

* ASA score \> 3
* Contraindication to loco-regional anaesthesia
* Patients with ileus or subocclusive condition prior surgery
* Coagulation disorders
* Organ failure or severe disfunction (heart, renal, pulmonary, hepatic)
* Uncontrolled hypertension (\>180/95)
* Alcohol or drug abuser (current or previous)
* Unability to self-care (PFS \< 70)
* Comorbidity-Polypharmacy Score \> 22
* Psychiatric condition or language barriers
* Planned Intensive Care Recovery
Nitrous Oxyde During Labour

1. Background to the clinical research project Nitrous oxide is a valuable tool in medicine for its rapid and effective analgesic and sedative properties. It is used in 50% gaseous form for painful procedures. One frequent application is obstetric analgesia. However, in addition to its analgesic effects, many articles mention the psychotropic, even psychedelic, effects of nitrous oxide use. In one of the most recent studies, entitled More than just joy: A qualitative analysis of participant experiences during nitrous oxide sedation, involving healthy volunteers, it is reported that the sensations and feelings of the subjects are not necessarily pleasant, and many volunteers report psychedelic-like sensations, dreams or disturbed perceptions. The authors then question whether these effects are due to an absence of painful stimuli and therefore an absence of a beneficial effect. The same effects have been reported by Atkinson et al, also on volunteer subjects. Parturients feelings are highly variable, with a stronger focus on analgesic efficacy.
2. Objectives of the clinical research project 2.1 Primary objective: The main objective will be to evaluate the effects of nitrous oxide, other than analgesia, in the specific context of childbirth. The study will focus mainly on subjective feelings, as well as the effects of disconnection from reality.

   2.2 Secondary objectives: As secondary objectives, we will study the efficacy on pain.
3. Methodology of the clinical research project All patients who have received nitrous oxide for delivery as part of the standard course of treatment in the delivery room will be contacted within 24 hours by one of the investigators. The protocol, i.e. the questionnaire, will be explained to the patients and, if they accept the protocol, written consent will be obtained. Patients will then complete the questionnaire in the presence of one of the investigators, who will be able to explain the questions if necessary. The questionnaire will take around 20 minutes to complete.
4. Design of the clinical research project Prospective study based on a questionnaire.
5. Participants Any person who received nitrous oxide for childbirth at Hôpital Érasme between October 1, 2024 and April 30, 2025 and who signed the informed consent form for this study.


Eligibility Criteria:
Inclusion Criteria:

* Any person who received nitrous oxide for childbirth at Hôpital Érasme between October 1, 2024 and April 30, 2025 and who signed the informed consent form for this study.

Exclusion Criteria:

* No informed consent
Photodynamic Therapy With PD P 506 A Compared With Placebo-PDT for the Treatment of AK

The aim of this study is to investigate whether PD P 506 A-PDT is effective in treating mild to moderate AK lesions located on the head.

Actinic keratosis (AK) is a pre-cancerous skin abnormality usually caused by sun exposure. Actinic keratoses occur most commonly in fair skin, especially in the elderly. They mainly occur in sun-exposed skin areas like head and hands. It is standard of care to remove AK when diagnosed, which can be achieved by either physical ablation, chemotherapeutic agents or photodynamic therapy (PDT). A direct comparison versus placebo which is necessary for the exact quantification of the effect of PD P 506 A has not yet been performed and is subject of this study protocol.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Caucasian patients
* Diagnosis of actinic keratosis (AK) with at least three locally separated lesions located on head and/or face (hairless areas)
* Selected AK study lesions have clearly defined margins and are mild to moderate
* The distance between the study lesion borders is \> 1.0 cm
* Maximum diameter of each study lesion is 1.8 cm
* Skin sun sensitivity type I to IV according to Fitzpatrick

Exclusion Criteria:

* PDT Non-responder
* Pre-treatment of the AK lesions eligible for study procedures with pharmaceuticals approved for the treatment of AK during the 4 weeks preceding PDT
* Pre-treatment of the AK lesions eligible for study procedures during the 2 weeks preceding PDT with keratolytic agents e.g. TCA, urea or salicylic acid containing formulations
* Pre-treatment with hypericin during the 2 weeks preceding PDT
* Treatment with systemic retinoids during the 3 months preceding PDT
* Treatment with cytostatics or radiation during the 3 months preceding PDT
* Female patients of childbearing potential
* Patients with clinically relevant suppression of the immune system
* Diagnosis of Porphyria
* Skin diseases that might interfere with response evaluation of study PDT
* Skin sun sensitivity type V or VI according to Fitzpatrick
* Known intolerance to one or more of the ingredients of the study medication
* Dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent
* Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding inclusion
* Suspected lack of compliance
The Relationship Between Body Mass Index and Patient Outcomes in Low Flow Anaesthesia

This study was designed as a prospective observational study.

In this study, it was planned to evaluate the effect of body mass index on patient outcomes during low flow anaesthesia in patients undergoing gynaecological cancer surgery on the specified dates. ASA II and III patients over 18 years of age were included in the study. Low flow anaesthesia is routinely applied in open gynaecological cancer surgeries in our clinic. The relationship between body mass index and intraoperative haemodynamic and mechanical ventilator values and postoperative patient outcomes will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ASA II-III
* \&gt;18 years
* Patients undergoing major open surgery for endometrium, cervix or ovarian ca in gynaecological oncology clinic

Exclusion Criteria:

* Patients who refused to participate in the study
* Cerebrovascular disease
* Those with severe pulmonary disease
* Those with serious cardiovascular disease
Cultures Before and After Decolonization in Community Dwelling Adults With Current S. Aureus Colonization

The investigators propose to study the microbiome of the nose, throat and three skin sites in a population without current exposure to the healthcare environment: 80 community dwelling adults. We will characterize the microbial communities in these body sites (nose, throat, perirectal and three skin sites) over time using culture-independent techniques. The investigators will then "decolonize" the subjects. Subjects will receive intranasal mupirocin and topical chlorhexidine. The investigators will then compare the microbial communities at baseline and after decolonization within individuals. Our overall hypothesis is that the microbial composition of these sites and the response to decolonization is influenced by the healthcare environment and that decolonization leads to re-colonization with an increasing proportion of Gram-negative bacilli.


Eligibility Criteria:
Inclusion Criteria:

* Veteran living in the greater Baltimore, MD area
* Adults \>= 18 years of age
* Living independently
* Willing and able to provide anterior nares, skin, throat, and perirectal specimens over an 18 week time period.
* Willing and able to administer intranasal mupirocin and topical chlorhexidine over a five day period
* Capable of understanding and complying with the entire study protocol.
* Provided signed and dated informed consent

Exclusion Criteria:

* Use of anticancer chemotherapy or radiation therapy (cytotoxic) within the past 6 months
* History of HIV infection with most recent CD4 of \<200
* Immunosuppression medications within the past 3 months
* Use of systemic antibacterial or antifungal agents in the past 3 months
* Use of nasal steroids currently or in the past 3 months
* Use of nasal antimicrobial ointment in the past 3 months
* Any current indwelling percutaneous medical device or urinary catheter
* Acute care hospitalization in the past 3 months
* Planned surgery or hospitalization during the study period
* History of an allergic reaction to chlorhexidine or mupirocin
* Oral temperature of \>100 F at enrollment visit
* BMI \<18 or \>35 at enrollment visit
Molecular Mechanisms Leading to Chemoresistance in Epithelial Ovarian Cancer

Epithelial ovarian cancer is the most lethal gynecological malignancy in developed countries and the fifth most common cause of cancer-related death in women. Poor prognosis is due to challenges in early diagnosis and development of inevitable resistance to chemotherapy in majority of patients despite of good initial treatment response. The purpose of this prospective study is to analyze variation in microRNA expression in prediction of primary treatment response and the role of microRNAs in development of chemoresistance in epithelial ovarian cancer.

• Objectives: To screen microRNAs from prospectively collected plasma, urine and tumor samples from patients diagnosed with epithelial ovarian cancer. Samples are analyzed for microRNA expression and differential expression is correlated with primary treatment response, progression-free survival and overall survival.

• Methods: Plasma, urine and tumor samples are collected at primary surgery (open surgery or diagnostic laparoscopy) or interval debulking surgery, at 1st, 3rd and 6th neoadjuvant or adjuvant chemotherapy and at progression for high-throughput screening of microRNA expression by array technology.

Inclusion criteria:

patients operated for a suspected ovarian malignancy in the Department of Obstetrics and Gynecology in Tampere University Informed consent obtained

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age, informed consent.

Exclusion Criteria:

* Informed consent not provided, age under 18 years.
Breast Cancer Exercise Intervention Study

This is a 24-week exercise programme consisting of aerobic exercise and muscle strength training, 3 sessions per week. The first 9 sessions are supervised by physiotherapists in person, followed by 63 sessions monitored remotely (video) or supervised by trainers at ActiveSG (Sport Singapore) gyms.

This is a multi-centre, randomised controlled study of a 6-month (24-week) exercise programme versus observation in 2156 early stage and locally advanced breast cancer patients who have undergone curative breast surgery, and who have completed (neo)adjuvant chemotherapy (if given) or radiotherapy (if given). Patients are stratified by centre (NCC/SGH, NUH), menopausal status, ER/PR status, body fat/muscle ratio.

Cardiorespiratory fitness, muscle strength, level of routine daily physical activity, body fat/muscle ratio are monitored during the study period.

Blood is collected at baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks, then annually for 4 times.

Questionnaires are periodically conducted to assess quality of life (QoL). A food diary is kept.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically proven stage 1, 2, or 3 breast cancer
* Patients who have undergone curative breast surgery
* Patients who have received (neo)adjuvant chemotherapy (if given) and/or radiotherapy (if given)
* Females aged 21 years and older
* ≤ 8 weeks from breast surgery, or the last adjuvant chemotherapy or radiotherapy session, whichever is latest.

Exclusion Criteria:

* Cardiovascular, respiratory, musculoskeletal problems that preclude moderate physical activity.
* Major medical problems that are deemed by the investigator to be unsuitable for enrollment.
Type 1 Diabetes, Endothelin, and Skeletal Muscle Mitochondrial Dysfunction: The Role of Sirtuin-1

The proposed study is designed to test the hypothesis that treatment of resveratrol for 12 weeks will improve both endothelin-B receptor (aim 1) and skeletal muscle mitochondrial function (aim 2) in people with type 1 diabetes.

Preliminary data from the investigators' laboratory demonstrate a negative relationship between hemoglobin A1c (HbA1c) and ETBR function, supporting ETBR may be dysfunctional in the presence of T1D. Using near infrared spectroscopy (NIRS) to non-invasively assess muscle function, the investigators have also observed reduced skeletal muscle mitochondrial function in people with T1D compared to healthy controls. In addition, reduced circulating Sirt1 is associated with both ETBR and skeletal muscle mitochondrial dysfunction in the general population. For the current application, the investigators propose to utilize intradermal microdialysis and NIRS as unique, novel, and minimally invasive methods to investigate ETBR and skeletal muscle mitochondrial function, respectively, in people with T1D. Accordingly, the central hypothesis is that increasing circulating Sirt1 with oral supplementation of resveratrol will improve both ETBR function and mitochondrial skeletal muscle function, reducing overall CVD risk (Figure 1). The investigators will test this hypothesis with the following specific aims:

Aim 1: To test the hypothesis that an increase in Sirt1 will improve ETBR function in people with T1D. The investigators will evaluate ETBR function and circulating Sirt1 at baseline and after a 12-week treatment of resveratrol or placebo. Based on preliminary data, the investigators predict that people with T1D will have ETBR dysfunction compared to controls. In addition, the investigators predict that increasing Sirt1 following resveratrol treatment will improve ETBR function, whereas no change will occur with placebo.

Aim 2: To test the hypothesis that an increase in Sirt1 will improve skeletal muscle mitochondrial function and lower HbA1c in people with T1D. A non-invasive assessment of skeletal muscle function will be performed on people with T1D before and after 12-weeks of treatment with resveratrol or placebo. Compared to controls, the investigators predict that people with T1D will have skeletal muscle dysfunction. Following 12 weeks of resveratrol, the investigators predict that the increase in circulating Sirt1 will improve skeletal muscle function. Additionally, the investigators predict the improved skeletal muscle function will contribute to a subsequent decrease in HbA1c in people with T1D.

Eligibility Criteria:
Inclusion Criteria:

* Men and premenopausal women
* All races
* Clinical diagnosis of insulin-dependent type 1 diabetes (patients only)

Exclusion Criteria:

* Clinical diagnosis of hepatic, cardiovascular, or renal disease
* Uncontrolled diabetes (HbA1C \>12%)
* Diabetic complications (i.e. neuropathy)
* Uncontrolled hypertension (\>140/90 mm Hg on therapy)
* Pregnancy
* Use of vasoactive medications