cyrilzakka/clinical-trials huggingface dataset:
Heat Stress in Wheelchair Sports

The aim of the study is to study the thermoregulatory responses under real life conditions, such as during wheelchair rugby and basketball matches. A further goal is to develop and validate a standardised field-based protocol, which induces the same thermoregulatory response as during a wheelchair rugby and basketball match. This knowledge allows to investigate strategies to reduce heat stress and to enhance exercise performance (e.g. pre-cooling) in the future, based on standardised conditions.

A spinal cord injury leads to several physiological changes and complications, which might influence exercise performance (Perret and Abel, 2016). One major problem is the limited thermoregulation, especially in subjects suffering from a tetraplegia (Griggs et al., 2015; Price et al., 2006). There are only few studies, which investigated the thermoregulatory response during real life conditions in wheelchair athletes such as during a wheelchair rugby match (Griggs et al., 2017). However, to implement strategies to reduce heat stress (e.g. precooling methods) or to determine the influence of heat stress on exercise performance and to determine the effects of specific interventions the following two issues seem to be a prerequisite: First of all, we need to understand, which thermoregulatory response is induced under real life conditions, e.g. by a wheelchair rugby or basketball match. Second, if we want to study the effects of potential interventions, a standardised and reliable study protocol has to be available, which closely mimics match conditions and induces a similar amount of heat stress. Thus, the aim of the study is to measure thermoregulatory and physical performance outcomes during a real life wheelchair rugby and basketball match. A further goal is to develop and validate a standardised field-based protocol, which induces a similar thermoregulatory response as during a wheelchair rugby or basketball match. These knowledge builds the basis for future thermoregulatory studies based on a reliable and standardised field-based testing protocol.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature
* healthy, male or female wheelchair rugby (with tetraplegia) or basketball player (with paraplegia) of national or international level
* regularly taking part in competitions/games
* age between 18 and 60 years

Exclusion Criteria:

* asthma
* blood disorders
* actual injury, which impairs performance or other impossibility to exercise to exhaustion
* cardiovascular disease
* gastrointestinal disease, disorder or former surgery concerning the gastrointestinal tract
* not able to swallow a capsule
* less than 40kg of body mass
* MRI during the period of use of the e-Celsius® device
Insomnia in Postmenopausal Osteoporosis

Aim of the study was to determine the presence of sleep problems in postmenopausal osteoporosis patients and to examine the relationship between the severity of insomnia and mood and fatigue. Pain, sleep problems, depression, anxiety, and fatigue were assessed using appropriate scales

The research was planned as a clinical cross-sectional study. Two hundred women, aged between 50-75 years, who were diagnosed with postmenopausal osteoporosis and followed up in the outpatient clinics of Beylikdüzü State Hospital and Istanbul Physical Medicine and Rehabilitation Training and Research Hospital between May 19, 2024, and June 19, 2024, were included. Sociodemographic data such as gender, height, weight, body mass index, educational status, and occupation were recorded. The date of osteoporosis diagnosis, history of falls within the last 6 months, presence of fractures due to low-energy trauma, osteoporosis treatment, medications used, and comorbidities were questioned. The presence and location of pain were asked, and if pain was present, its intensity was determined using the Visual Analog Scale. Calcium and vitamin D levels from the last 3 months were recorded. The patient's sleep problems were assessed using the Insomnia Severity Index. Subsequently, the patient's current depression and anxiety-related symptoms were measured using the Hospital Anxiety and Depression Scale (HADS), and the fatigue level was assessed with the Fatigue Severity Scale (FSS).

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with postmenopausal osteoporosis.
* Patients who agreed to participate in the study.
* Age range between 50-75 years.

Exclusion Criteria:

* Presence of fibromyalgia.
* Chronic fatigue syndrome.
* Chronic decompensated cardiac, renal, or hepatic failure.
* Known psychiatric disorders.
* Rheumatological diseases.
* Presence of other known neurological diseases.
* Use of medications that enhance physical performance or alleviate fatigue.
A Study of Soundscapes for Patient Wellbeing

The purpose of this study is to assess the impact of immersive soundscape on patient pain, stress, anxiety, heart rate and blood pressure during an outpatient vascular surgery procedure.

Adult (≥18-years-old) patients having outpatient vascular surgery procedures who elect to participate in the study will be randomized to Control/ Intervention. For Control Subjects: procedure will be performed in the procedure room with no immersive soundscape. For Intervention Subjects procedure will be performed in the procedure room with immersive soundscape.

Eligibility Criteria:
Inclusion Criteria:

- English-speaking adults

Exclusion Criteria:

* Patients needing an English interpreter
* Patients who lack the capacity to provide consent.
Adaptive Nutrition Therapy in Hemodialysis

8-week adaptive nutrition intervention for participants undergoing hemodialysis, consisting of nutrition education and meal kit.


Eligibility Criteria:
Inclusion Criteria:

* have been on hemodialysis for over 3 months

Exclusion Criteria:

* diagnosed with cancer within 5 years
Zenith® Low Profile AAA Endovascular Graft

The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft used in conjunction with the Zenith® Spiral-Z® AAA Iliac Leg Graft to treat abdominal aortic, aortoiliac, and iliac aneurysms.


Eligibility Criteria:
Inclusion Criteria:

* Subject has at least one of the following

  * Aortic or aortoiliac aneurysm
  * Iliac aneurysm
  * Aneurysm with a history of growth

Exclusion Criteria:

* Less than 18 years of age
* Inability or refusal to give informed consent
* Disease considerations that would compromise patient safety or study outcomes
* Pregnant of breastfeeding or planning on becoming pregnant with 60 months
* Unwilling to comply with the follow-up schedule
Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations

The primary objective of this study is to compare pharmacokinetic (PK) profiles and assess the bioequivalence between the newly developed nicotine gums (2 mg and 4 mg) and the reference nicotine gums (2 mg and 4 mg) in healthy smokers.


Eligibility Criteria:
Inclusion Criteria:

* BMI within the range of 19 to 30 kilograms/meters\^2
* Current cigarette smokers who have smoked daily for at least a year, and smoke their first cigarette within 30 minutes of waking up

Exclusion Criteria:

* Participants who have attempted to quit smoking in the last 12 months, are currently attempting to quit smoking or reduce the number of cigarettes they smoke, or are intending to quit smoking in the next 3 months, with or without use of smoking cessation aids
* Treatment with known hepatic enzyme altering agents
Acute Effects of Exercise on the Cortical Silent Period in Prostate Cancer Patients

In Canadian men, prostate cancer (PCa) is the most prevalent form of cancer and the third leading cause of cancer-related death. Unfortunately, PCa survivors are often burdened with feelings of anxiety and depression associated with the disease and associated treatments. Short-term exercise interventions (8-24 weeks) have improved psychosocial well-being in this population, but the impact of single bouts of exercise and related psychological or neurological changes have never been studied. The primary objective of the proposed study is to examine the effect of an acute bout of exercise on neurophysiological and psychological indicators of well-being in a randomized controlled trial (RCT) of 36 men with PCa. Participants will be randomly assigned to the intervention (60 min exercise) or control (60 min of television) and will undergo a brief neurological test (cortical silent period) and psychological questionnaires before and after their group assignment.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed PCa;
* \> 6 months post curative therapy for PCa (radical prostatectomy or radiation therapy) with or without adjuvant androgen deprivation therapy;
* Willing and able to provide informed consent;
* If metastatic disease is present, they are asymptomatic; v) n
* No contraindications to exercise

Exclusion Criteria:

* Severe coronary artery disease (Canadian Cardiovascular Society class III or greater);
* Significant congestive heart failure (New York Heart Association class III or greater);
* Uncontrolled pain;
* Neurological or musculoskeletal co-morbidity inhibiting exercise;
* Diagnosed psychotic, addictive, or major cognitive disorders or are currently or have a history of using psychotropic medication (anti-depressants, anti-anxiety, anti-psychotics, benzodiazepines, etc);
* Contraindications to magnetic exposure (surgical clips in the brain; cardiac pace maker or valves; cochlear implants; metal rods, plates, screws in head; shrapnel/metal fragments in head/eyes; dentures);
* Prior history of seizures or diagnosis of epilepsy;
* Left-hand dominant; and
* No more than two of the following Coronary Risk Factors as defined by the American College of Sports Medicine\[41, 42\]:

  * Family history of coronary disease, cigarette smoking, hypertension (Systolic Blood Pressure (SBP) \> 140 mmHg; Diastolic Blood Pressure (DBP) \> 90 mmHg), known dyslipidemia, known impaired fasting, glucose (\>110 mg/dL), obesity (BMI \> 30 kg/m2 or waist circumference \> 102cm), or physically inactive (\<150 min of moderate intensity physical activity per week)
Evaluation of Glycemic Variability (GLAIVE)

This study compared two methods of insulin infusion by syringe pumps to assess the impact of medical devices on the glycaemic variability in patients under IIT in ICU. The main objective of the study was to show the superiority of the infusion system which permitted to dedicate a line for the insulin administration on the "standard" installation in terms of control of glycaemic variability.


Eligibility Criteria:
Inclusion Criteria:

* Patients under postoperative intensive care
* Treatment with insulin on bi-lumen central venous catheter over than 48 hours
* Eligibility for interstitial glucose monitoring
* Blood glucose control every 3 hours

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patient unwilling to participate in the study
* Patients participating in another study biomedical over the same period
* Patient can not understand the study and its objectives
* Patient under guardianship, curatorship
* Patient malnourished (BMI \<18 kg / m²)
* Patient with morbid obesity (BMI\> 40 kg / m²)
* Patient in shock (septic or hemodynamic)
* Patients refusing to sign the Medtronic consent on the storage of personal data
Relationship Between Constitutional Varus Knee and Patellofemoral Pain

This study aims to research on the relationship between constitutional varus knee and patellofemoral pain. The standardized standing whole-lower-extremity radiographs, the knee lateral view and skyline view of the participants will be taken. The hip-knee-ankle angle will be obtained from the radiographs. According to the hip-knee-ankle angle, the knees will be labelled knee varus or knee nonvarus. The knee varus incidences of the two groups will be determined and compared.

The patellofemoral joint will be assessed in the skyline view and lateral view. The hip-knee-ankle angle will be obtained from the standing whole-lower-extremity radiographs. According to the hip-knee-ankle angle, the knees will be labelled knee varus or knee nonvarus. The knee varus incidences of the two groups will be determined and compared. It is hypothesized that constitutional varus knee is a risk factor for patellofemoral pain.

Eligibility Criteria:
Inclusion Criteria:

* Patellofemoral pain during physical activities such as running, jumping, squatting, and going up or down stairs for at least 4 weeks.
* The onset of pain is required to be atraumatic in nature.
* Exhibit two of the following clinical criteria on assessment: pain on direct compression of the patella against the femoral condyles with the knee in full extension, tenderness of the posterior surface of the patell on palpation, pain on resisted knee extension, and pain with isometric quadriceps muscle contraction against suprapatellar resistance with the knee in 15° of flexion.
* Negative findings in the examination of knee ligaments, menisci, bursae, synovial plicae, Hoffa's fat pad, iliotibial band, and the hamstring, quadriceps, and patellar tendons and their insertions.

Exclusion Criteria:

* With patellofemoral instability, or With other knee diagnoses.
* Any previous surgery or severe trauma in the affected limb.
* Inflammatory joint disease or tumors in the affected limb.
Effect on Fenoterol Metered Dose Inhaler on the Beta-receptor Population on Lymphocytes in Patients With Bronchial Asthma

The aim of the study was to compare the effect of fenoterol metered dose inhaler with disodium cromoglycate (DSCG) metered dose inhaler on the lymphocyte β2-receptor population as well as on the clinical findings in patients with bronchial asthma over a two-week period of treatment.


Eligibility Criteria:
Inclusion Criteria:

* sex: male and female
* age: 18 years or over
* bronchial asthma, diagnosis confirmed by history and positive inhalation challenge test (unspecific challenge with carbachol, PD100SRaw))
* severity of asthma mild to moderate or asthmatic in symptom-free intervals
* Raw ≤ 5 cm H2O/l/s
* no antiasthmatic treatment in the week (steroid therapy: two weeks) before the start of the study

Exclusion Criteria:

* clinically significant, concomitant haematological, cardiac, renal, hepatic or metabolic diseases
* intercurrent diseases, e.g. severe respiratory infections
* patients who cannot do without the following preparations during the 5-week trial:

  * inhaled/oral steroids
  * theophylline
  * antihistamine, antiallergic drugs
  * inhaled/oral sympathomimetics
  * anticholinergics
Oxytocin Dosing at Planned Cesarean Section and Anemia

Patient's with planned cesarean sections will be randomized to receive either standard 20 mU in 1L as a bolus following delivery of the placenta or 20 mu in 1L following delivery of the placenta plus an additional 20 mU in 1L over 8 hours.

The purpose of this study is to examine the impact of differential dose protocols commonly utilized in the post cesarean period to determine if laboratory definitions of anemia are different. Oxytocin is an antidiuretic hormone that is utilized after delivery of the fetus and placenta to contract the uterus and decrease blood loss both at the time of surgery and in the post-partum period. Here at the Penn State Hershey Medical center the investigators will use 20 units of oxytocin in a 1 L bag of LR in bolus fashion after delivery of the placenta. Other protocols use an extended course of therapy using 20 units of oxytocin in a 1 L bag of LR in a bolus plus an additional 20 units of oxytocin in a 1 L bag of LR over an 8 hour period of time.

We hypothesize that:

* Women who receive the standard 20 mU of oxytocin in 1L of LR in bolus fashion plus 20 mU in 1L over 8 hours will have a decreased reduction in pre-operative vs post-operative hematocrit and hemoglobin versus those that receive 20 mU in 1L of LR.
* Women who receive the standard 20 mU of oxytocin in 1L of LR in bolus fashion plus 20 mU in 1L over 8 hours will have decreased blood loss by weight in the postpartum period compared to patients who receive 20 mU in 1L of LR.

Eligibility Criteria:
Inclusion Criteria:

* Planned cesarean sections for singletons at or greater than 37 weeks gestational age
* Primary or repeat cesarean section will be included

Exclusion Criteria:

* Multiple fetal pregnancies
* Hematologic disorders
* Fetal anomalies
* Pre-eclampsia. These patients are at increased risk of fluid overload and so fluid status may be affected by receiving a second bag of fluid containing oxytocin in the postpartum period.
* Known contraindication to oxytocin
* Hypersensitivity to oxytocin
* Patients who have labored and then proceed with cesarean section for any reason. Patients who have labored have had either intrinsic or extrinsic exposure to oxytocin. These patients may have decreased sensitivity to oxytocin.
Evaluation of Pain in the Course of in Vitro Fertilization

25 to 50% of endometriotic patients are infertile and use medically assisted procreation. In general, the assessment of pain in medically assisted procreation is very little studied. Pain assessment studies in endometriotic patients remain limited to a quantitative assessment of pain symptomatology, without contextualization of painful manifestations. The primary objective of our study is the qualitative and contextualized assessment of pain during In Vitro Fertilization (IVF) protocol in endometriotic and non-endometriotic patients. The secondary objectives of our study are the quantitative study of pain, the measurement of the impact of personal efficiency on painful symptomatology, evaluation of depression, the results of IVF (implantation, pregnancy and live birth rates), and compare pain between endometriotic or non-endometriotic patients and between primary infertility and secondary infertility. According to the results obtained in this study, therapeutic strategies for the management of pain could be proposed, with the aim of improving the quality of life and the results of IVF in these patients.


Eligibility Criteria:
Inclusion Criteria:

* All patients who start an IVF cycle in the medically assisted procreation department of the Jeanne de Flandres Hospital (CHRU Lille)

Exclusion Criteria:

* Refusal to participate in the study
* Minor patient
* Patient over 43 years old
* BMI patient \> 35
* Pregnant woman
* Unable to provide clear information to the patient
* Patient under guardianship or lack of health cover
* Patient in IVF with donation of oocyte
* IVF patients for oocyte preservation
* Patient who had already participated in the study
Combination of BTK Inhibitor Overcomes Drug-resistance in Refractory/Relapsed FLT3 Mutant AML

Clinical efficacy of FLT3 inhibitors combining with chemotherapy is usually transient and followed by emergence of drug-resistance in FLT3-ITD mutant AML. BTK is reported to be a therapeutic target in this subtype leukemia. Our previous study showed inhibition of BTK onvercome drug-resistance to FLT3 inhibitors/chemotherapy in refractory/relapsed FLT3 mutant AML. In this prospective randomized controlled study, the efficacy and safety of combination of BTK inhibitor with chemotherapy with/without FLT3 inhibitor in refractory/relapsed FLT3 mutant AML are evaluated.

Clinical efficacy of FLT3 inhibitors combining with chemotherapy is usually transient and followed by emergence of drug-resistance in FLT3-ITD mutant acute myeloid leukemia (AML). How to overcome the resistance to FLT3 inhibitors or chemotherapy needs further study. Bruton's tyrosine kinase (BTK) is reported to be a therapeutic target in this subtype leukemia. Our previous study showed inhibition of BTK onvercome drug-resistance to FLT3 inhibitors/chemotherapy in refractory/relapsed FLT3 mutant AML. In this prospective randomized controlled study, we are going to inhibit BTK with BTK inhibitor ibrutinib in the patients with refractory/relapsed FLT3 mutant AML, and then test the enhancing effect and safety of combination of ibrutinib with chemotherapy with/without FLT3 inhibitor, to make sure inhibition of BTK overcomes drug-resistance in FLT3 mutation AML.

Eligibility Criteria:
Inclusion Criteria:

Refractoty/relapsed FLT3-ITD mutation AML Age 14-60

Exclusion Criteria:

Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) Patients with any conditions not suitable for the trial (investigators' decision)
Medical & Economical Evaluation of Fenestrated & Branched Stent-grafts to Treat Complex Aortic Aneurysms

The aim of this study is to prospectively compare the perioperative mortality severe morbidity and the costs of endovascular versus conventional surgical repair of pararenal, supra-renal and type 4 THORACO-abdominal aortic aneurysms.

The primary goal of the study is to demonstrate a significant drop in 30-day mortality and life threatening morbidity in the endovascular arm of the study. Our hypothesis, derived from the literature, that the average 30-days mortality is 3% after endovascular repair and 10% after open surgery justifies the design of a prospective study between endovascular therapy (250 patients (amendment) treated in 8 University hospitals with significant experience of the technique) and open repair (660 similar patients analyzed form the national database of the MOH).

The aim of this study is to prospectively compare the perioperative mortality severe morbidity and the costs of endovascular versus conventional surgical repair of pararenal, supra-renal and type 4 THORACO-abdominal aortic aneurysms.

The primary goal of the study is to demonstrate a significant drop in 30-day mortality and life threatening morbidity in the endovascular arm of the study. Our hypothesis, derived from the literature, that the average 30-days mortality is 3% after endovascular repair and 10% after open surgery justifies the design of a prospective study between endovascular therapy (250 patients (amendment) treated in 8 University hospitals with significant experience of the technique) and open repair (660 similar patients analyzed form the national database of the MOH).

In-hospital morbidity are similarly expected to be lower in the endovascular group. We also wish to demonstrate that endovascular repair does not represent a significant over-cost, as compared to open repair. The cost of the implantable medical device (IMD), of follow-up screening, and of eventual repeated interventions should be compensated by a reduced stay in intensive care unit ICU, and by a reduced in-hospital length of stay.

Eligibility Criteria:
Inclusion Criteria:

The following anatomical inclusion criteria must be met:

* Absence of significant angulations (\< 60°) of aorta or of iliac arteries
* Absence of tight stenosis (\>70%) of more than one target artery (renal or visceral artery to be perfused from the side holes of the stent-graft)
* Diameter of target arteries over 5 mm
* Iliac and femoral arteries allowing insertion of the delivery system (\> 7 mm) or suitable for insertion of an access conduit

Exclusion Criteria:

* Limited expected life expectancy
* Emergency cases
* Refuse to participate to the study