cyrilzakka/clinical-trials huggingface dataset:
Respiratory Depression During an Analgosedation Combining Remifentanil and Ketamine in TCI for Oocyte Retrieval

This study evaluates the effect of the addition of ketamine to a conscious sedation protocol including remifentanil during oocyte retrieval. The investigators will have 2 groups with different target effect site concentrations, namely 150 ng/ml and 200 ng/ml.

The actual protocol for conscious sedation during oocyte retrieval in at the Erasmus hospital (Brussels) consists of Remifentanil in TCI-mode, with premedication by Midazolam. However, episodes of bradypnaea with or without desaturation are still common.

The primary objective is to observe if with the addition of ketamine, it is possible to significantly reduce the dose of Remifentanil, in order to avoid episodes of respiratory depression caused by the opioid.

The secondary outcomes measured, will be the pain levels experienced by the patient, the sedation level, and the satisfaction of the patients after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* patients having an oocyte retrieval

Exclusion Criteria:

* BMI \> 30
* endometriosis
* contraindications to ketamine
Vitamin D3 Substitution in Vitamin D Deficient Kidney Transplant Recipients

The purpose of the study is to evaluate the effects of Cholecalciferol (Vitamin D3) substitution on the posttransplant outcome (glomerular filtration rate as well as serum creatinine levels, number of acute rejection episodes, number of infections and C-reactive protein levels within the first year after transplantation) in vitamin D deficient kidney transplant recipients.

Apart from its classical actions in calcium homeostasis, vitamin D acts as a potent immunomodulatory agent. As such, vitamin D is thought to have beneficial effects in the transplant setting, especially in kidney transplant recipients considering the fact that approximately 40% of all kidney transplant recipients are vitamin D deficient.

Therefore, the objective is to conduct a randomized, double-blind, placebo-controlled study focusing on the impact of Cholecalciferol substitution in vitamin D deficient kidney transplant recipients on graft function (glomerular filtration rate as well as serum creatinine levels), incidence of acute rejection episodes, frequency and severity (CRP levels) of posttransplant infections within the first year after kidney transplantation.

Moreover, the impact of Vitamin D3 on renal osteodystrophy will be analyzed by means of bone mineral density. DXA measurements will be performed during the first four weeks after kidney transplantation, after 5, and after 12 months posttransplant.

Kidney transplant recipients found to have vitamin D deficiency (defined as 25-hydroxyvitamin D \< 50 nmol/l) will be included and will be randomized to receive either oral Vitamin D3 therapy or placebo. Vitamin D3 will be administered at a daily dose of 6800IU over a time period of one year.

All in all, 200 subjects will be included in the VITA-D study.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18
* deceased donor kidney transplant recipients
* only kidney transplant recipients
* vitamin D deficiency defined as 25 (OH)D \< 50nmol/l

Exclusion Criteria:

* re-transplantation for the second time if the patient is highly immunized and therefore included in the aphaeresis program
* re-transplantation for the third or further time
* significant impaired intestinal resorption: malabsorption due to celiac sprue, systemic scleroderma; maldigestion due to chronic pancreatitis, pancreatic insufficiency, pancreas resection, mucoviscidosis, Zollinger-Ellison-syndrome
* history of inflammatory bowel disease: Crohn's disease, ulcerative colitis
* previous gastrectomy, small bowel or large bowel resection, intestinal bypass surgery
* severe liver disease: cirrhosis
* HIV positive
Effect of Lidocaine on Postoperative Pain and Long-term Survival in Elderly Patients Undergoing Colorectal Surgery

This study is a further observation and follow-up of the patients enrolled in the registration number NCT05920980 to further evaluate the effect of long-term infusion of lidocaine on postoperative chronic pain, long-term quality of life and survival rate in patients undergoing colorectal cancer surgery.

This study is a further observation and follow-up of the patients enrolled in the registration number NCT05920980 to further evaluate the effect of long-term infusion of lidocaine on postoperative chronic pain, long-term quality of life and survival rate in patients undergoing colorectal cancer surgery. Patients who meet the enrollment criteria will be randomized 1:1 to the lidocaine group or placebo group. In the lidocaine group, lidocaine 1.5mg/kg/h was continuously infused (using ideal body weight) during the whole procedure. Postoperative analgesia pump with lidocaine (lidocaine 50mg/kg, sufentanil 2ug/kg, glassetron 12mg) diluted to 200ml with saline until 72h after surgery. In the placebo group, the same volume of normal saline will be administered during anesthesia. The postoperative PCIA device will contain sufentanil 2μg/kg, granisetron 12mg diluted to 200mL in 0.9% normal saline solution with a total volume of 200mL.Follow-up after discharge includes chronic pain, the impact of chronic pain on quality of life, the relapse-free survival and overall survival from postoperative 3 months to 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Participants were at least 60 years old;
2. American Society of Anesthesiologists (ASA) physical status I to III;
3. Body-mass index of 18-30 kg/m2;
4. Scheduled for elective colorectal surgery.

Exclusion Criteria:

1. Metastases occurring in other distant organs;
2. Severe hepatic insufficiency (aspartate aminotransferase or alaninetransaminase or bilirubin \>2.5 times the upper limit of normal);
3. Renal impairment (creatinine clearance \<60 mL/min);
4. Cardiac rhythm disorders or systolic heart failure (second-and thirddegree heart block, ejection fraction \<50%);
5. Allergies to any of the trial drugs; chronic opioid use;
6. Inability to comprehend numeric rating scale.
Malabsorption Blood Test:Toward a Novel Approach to Quantify Steatorrhea

\*The purpose of this study is to develop a more accurate, reliable, specific and more acceptable alternative clinical test to the 72-hour stool and diet collection for quantifying fat malabsorption in people with CF and pancreatic insufficiency.

* Nine subjects with CF will be recruited to complete the MBT on two separate occasions, with different doses of pancreatic enzymes
* At each MBT visit, subjects will receive a specific enzyme dose just before they drink the test meal (shake)
* Fat absorption is maximized when the enzymes are taken with the shake.
* If subjects usually receive brands of pancreatic enzymes different from Creon, their dose will be converted to an equivalent dose of Creon 20 for the study.

Prior to each study visit all subjects will be required to:

* Eat their usual diet for 2 days prior to MBT
* Refrain from consuming alcohol or dairy products for 24 hours prior to MBT
* Refrain from non-routine physical exercise for 20 hours prior to MBT
* Adhere to a 12-hour fast prior to MBT (from 8 PM previous night)
* Can drink water from 8:00 PM on the night before the test to 2:00 AM on the day of the test
* At visits 1 and 2, blood samples will be obtained at hourly intervals over a period of eight hours.
* Samples will be analyzed for PA, HA and Triglyceride concentrations.
* Patients will be permitted to ingest non-caloric and non-caffeinated beverages.
* At hour 6, patients will be provided 1000 Kcal, low fat (12 grams of fat) lunch meal.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with cystic fibrosis and pancreatic insufficiency (n=9), 8 years of age or older, in usual state of good health will be eligible to participate in this Aim.
* Subjects will be screened for genotype and a history of pancreatic insufficiency (PI). PI will be confirmed by measurement of fecal elastase 1\< 200 mg/g stool.

Exclusion Criteria:

* Subjects will be ineligible if they have an FEV1 % predicted of \< 40%, a history of fibrosing colonopathy or any significant bowel resection (\>10 cm) with the exception of a routine, uncomplicated appendectomy.
* Subjects with diabetes mellitus or disorders associated with altered energy metabolism (i.e. hypothyroidism), or any major illnesses that affect the gastrointestinal tract, will not be eligible for the study.
* Subjects with significant liver disease, or significant developmental delay will also be excluded.
* Subjects will be excluded if they have a food allergy related to any components of the experimental shake (i.e., soy or chocolate) or the stool marker, carmine red.
* Subjects who are pregnant are not eligible. Subjects with a history of intolerance or allergy to Creon 20 will be excluded from the study.
Characteristics, Phenotypes, and TRAITS of Heart Failure With Preserved Ejection Fraction (TRAITS-HFpEF)

Heart failure with preserved ejection fraction (HFpEF), a certain type of heart failure, occurs when the heart doesn't pump blood around the body properly. It can cause breathlessness, tiredness, and swollen feet or ankles. It is not clear why people develop HFpEF and treatment options are very limited.

TRAITS-HFpEF is a study that aims to understand why people develop HFpEF, identify new tests and treatments, and gain information on the life expectancy of people living with this condition. It will do this by routinely collecting information on people attending a specialised outpatient HFpEF clinic.

HFpEF represents the single largest unmet need in cardiovascular medicine (Butler et al, 2014). The proportion of patients with HFpEF ranges from 22 to 73% of all heart failure patients across all clinical settings, including primary care, hospital care and hospital admission (Ponikowski et al, 2016).

Treatment options in HFpEF are very limited, and several clinical trials have demonstrated neutral results when assessing survival benefit from medical therapy. A common theme for this is the heterogeneity that exists in the HFpEF patient population and non-targeted therapy is inadequate for this diverse population. Patients need to be characterised according to their clinical phenotypes and underlying biological mechanisms in order to provide targeted patient-specific treatment. (Shah et al, 2016)

TRAITS-HFpEF is an observational cohort study that aims to assess the epidemiology, and the association of clinical variables and outcomes of patients with HFpEF. A dedicated specialist HFpEF clinic provides the opportunity to recruit and collect data on a large cohort of patients that can provide insights into different HFpEF phenotypes and their associations and outcomes. This can help direct future research and delivery of specialist care.

All patients attending the HFpEF clinic at Manchester University NHS Foundation Trust (MFT) will be approached. The expectation is to recruit approximately 1,250 patients over a 5-year period. With the patients consent, a blood sample of approximately 10mL will be taken for biobanking to allow measurement of yet to be identified biomarkers, including plasma and DNA. This will be optional for patients. All clinical variables will be documented at the time of the recruitment.

Eligibility Criteria:
Inclusion Criteria:

* Patients attending the HFpEF clinic at MFT.

Exclusion Criteria:

* Age \< 18 years
* Imprisonment
* Inability to provide full written or verbal informed consent in English
The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial

This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or stroke) in people with coronary heart disease.

Subjects who qualify for the study will be randomized 1:1 to either darapladib or placebo administered in addition to standard therapy. Following the baseline visit, subjects will be expected to return for clinic visits at 1 month, 3 months, and every 6 months until the end of the study. Average time in the study for an individual subject is expected to be about 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Men or women at least 18 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
* Current treatment with statin therapy unless the study doctor determines statins are not appropriate for the subject.
* Chronic coronary heart disease
* At least one of the following:
* At least 60 years old
* Diabetes requiring treatment with medication
* Low HDL cholesterol ("good cholesterol")
* Currently smoke cigarettes or stopped smoking within the past 3 months
* Diagnosed mild or moderate reduction in kidney function
* Cerebrovascular disease (carotid artery disease or ischemic stroke more than 3 months prior to study entry) OR peripheral arterial disease.

Exclusion Criteria:

* Planned coronary revascularization (such as stent placement or heart bypass) or any other major surgical procedure.
* Liver disease
* Severe reduction in kidney function OR removal of a kidney OR kidney transplant
* Severe heart failure
* Blood pressure higher than normal despite lifestyle changes and treatment with medications
* Any life-threatening disease expected to result in death within the next 2 years (other than heart disease)
* Severe asthma that is poorly controlled with medication
* Pregnant (Note: A pregnancy test will be performed on all non-sterile women prior to study entry)
* Previous severe allergic response to food, drink, insect stings, etc.
* Drug or alcohol abuse within the past 6 months OR mental/psychological impairment that may prevent the subject from complying with study procedures or understanding the goal and potential risks of participating in the study.
* Certain medications that may interfere with the study medication (these will be identified by the study doctor)
* Participation in a study of an investigational medication within the past 30 days
* Current participation in a study of an investigational device
Hypnosis for Chronic Idiopathic Pruritus

Chronic idiopathic pruritus (CIP) is a frequent and disabling condition, for which there is no specific treatment. It was shown previously that hypnosis can relieve painful sensations. Pain and pruritus share many similarities regarding sensory receptors and pathways, suggesting that hypnosis might help relief CIP.

Chronic idiopathic pruritus (CIP) is a frequent and disabling condition, with significative impact on quality of life. At present, there is no specific treatment for CIP. Topical steroids are frequently used, with partial efficacy, and adverse effects. Hypnosis is a specific state of conscience. It differs from waking state, sleeping state, relaxation, or meditation. In this state, the person is highly responsive to suggestion. In medicine, hypnosis can be used to engage the internal resources of the person against unpleasant feelings. It was shown previously that hypnosis can relieve painful sensations. Pain and pruritus share many similarities regarding sensory receptors and pathways, suggesting that hypnosis might help relief CIP.

Eligibility Criteria:
Inclusion Criteria:

* Male or female of at least 18 years at screening
* Diagnosis of chronic (at least 6 wks.) idiopathic pruritus
* Pruritus Numeric Rating Scale \> = 4

Exclusion Criteria:

* Pruritus caused by a dermatological or a systemic conditions
* Suicidal crisis, moderate, or severe
* Psychosis (schizophrenia, persistent delusional disorder)
* Bipolar disorder, not stabilized or decompensating
* Personality disorder, decompensated
Clinical Study of the HeartLight X3 Endoscopic Ablation System With Excalibur Balloon

The objective of the study is to demonstrate the improved ablation and procedure times of the HeartLight X3 compared to the current HeartLight catheter in the treatment of atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* paroxysmal atrial fibrillation failure of at least one AAD others

Exclusion Criteria:

* overall good health as established by multiple criteria
Microbiome Comparison Profile of Normal Skin and Acne Vulgaris Patients

The aim of this study is to compare the profile of the microbiome on normal skin and acne vulgaris patients. A cross sectional study with 144 samples, male or female between 18-40 years old, from January to May 2023.

Recently, research on the role of the microbiome in the process of acne vulgaris has continued to grow. Seeing the important role of the microbiome in maintaining the balance of skin health, this study aims to compare the profile of the microbiome on normal skin and on acne vulgaris patients, in order to gain a deeper understanding the role of the microbiome in acne vulgaris and also to compare skin microbiome features in various degrees of acne vulgaris severity. This research is an observational study with a cross sectional design. Subject selected by consecutive sampling, with total 144 samples consists of males and females age 18-40.

There will be two visits in this research. The first visit, for screening patients with requests for informed consent, giving facial soap, screening for inclusion and exclusion criteria, screening for facial skin complaints and facial care habits, collecting data on patient demographics and medical history, physical examination, sebumeter examination to measure sebum levels on facial skin, and taking clinical photos for documentation. The second visit is collecting microbiome data which will be taking in 1 to 2 weeks after the first visit. Using swab method to take microbiome samples, after that, there will be DNA extraction, amplification and sequencing were carried out on the sample and the Shannon Index will be calculated. Then, the data will be tabulated and analyzed according to the hypothesis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18-40 years old
* Normal individuals who have not had acne vulgaris in the last 5 years and have never had moderate or severe acne vulgaris
* Patients with mild, moderate, or severe acne vulgaris who have acne vulgaris lesions that are representative of the grade and equally distributed in all facial regions (forehead, cheeks, and chin)
* Patients agree to participate in the study and sign informed consent

Exclusion Criteria:

* Pregnancy
* Diagnosed with other inflammatory or infectious diseases on the face
* Diagnosed with psoriasis or have atopic
* Diagnosed with primary or secondary immunodeficiency disease
* Patients with a history of laser therapy or facial dermabrasion within the past month
* Using oral or systemic antibiotics, anti-inflammatory, retinoids or hormone therapy in the last 1 month
* Using topical retinoid therapy, antibiotics, benzoyl peroxide, or other topical products in the last 2 weeks
* Acne conglobata
Case Series_Targeted Training for Trunk Control Cerebral Palsy

Little is known about how children with cerebral palsy (CP) use their sensory systems (touch, sense of body position, balance organs in the inner ear, vision) to help them achieve trunk control for independent sitting. If a child with CP does not achieve trunk control by 4 years of age their prognosis for motor skill development including walking is poor. Clinical researchers at The Movement Centre in Oswestry, England have developed a method called Targeted Training in which children train trunk control in small segments from the top down using a custom fit training device. This study aims to examine how children with moderate to severe CP use sensory information for trunk control before, during and after a program of Targeted Training.

One of the major challenges of motor control is to understand how the central nervous system controls the degrees of freedom of the body. This is particularly evident in cerebral palsy (CP), which is the most prevalent chronic childhood motor disability and is one of the most disabling and costly chronic disorders of children and adults. Deficits in postural control and sensorimotor integration are hallmarks of CP. Although postural control of the trunk for independent sitting creates the foundation for all other motor tasks, surprisingly little is known about how children with CP use sensory input to guide their development of upright control (which occurs in typically developing infants by 8 months of age). This lack of knowledge limits our ability to effectively assess and treat children with neuromotor deficits in trunk control.

The objectives of this project are to identify sensory reliance and sensory re-weighting in a study of children with moderate-to-severe CP (4-12 years of age) before and after Targeted Training for Trunk Control. A novel trunk support device will enable testing of participants who lack (or are still developing) stable sitting. In experiments, kinematics of the head and trunk will be measured. Sensory reliance and re-weighting will be identified from postural trunk responses to sensory conflict stimuli consisting of tilts of a visual surround and/or tilts of a surface which participants sit upon. Generally, participants with a high reliance on vestibular feedback will remain upright with respect to gravity during all tests; whereas a high reliance on cutaneous or visual feedback will produce trunk sway away from upright and toward the surface or visual surround tilt, respectively. To tease apart biomechanical, physical, and neurological contributions to trunk sway, sensorimotor integration modeling will be used to complement data interpretation.

Eligibility Criteria:
Inclusion Criteria:

* cerebral palsy
* age 2-12 years
* Gross Motor Function Classification System (GMFCS) Level III, IV or V

Exclusion Criteria:

* spinal fixation
* fixed scoliosis
* uncontrolled seizures
Floatation Experience in Nurses and Physicians

The goal of this observational study is to monitor the floatation experience and continue the program as long as deemed important. The main question it aims to answer is: will inventory wellbeing scores increase according to the number of floatation sessions accrued? Nurses (registered, practitioner, and anesthetist) and physicians, employed at St. Elizabeth Youngstown Trauma Center, Mercy Health, will be welcomed to participate in the floatation experience. Participants will be given an option to complete the Wellbeing Inventory survey prior to each floatation session.

The floatation program is a Mercy Health enterprise sponsored by the Mercy Health Mahoning Valley Foundation.The goal of this study is to monitor the floatation experience and continue the program as long as deemed important. The investigators hypothesize that inventory wellbeing scores will increase according to the number of floatation sessions accrued. Nurses (registered, practitioner, and anesthetist) and physicians, employed at St. Elizabeth Youngstown Trauma Center, Mercy Health, will be welcomed to participate in the optional floatation program in Warren, Ohio at no financial cost to them. They will become aware of floatation options through the Mercy Health Be Well wellness program. Floatation monitoring will include assessments of wellbeing, nonstress, and positive affect scores. Participants will be given an option to complete the Wellbeing Inventory survey prior to each floatation session. This will be a self-reporting anonymous process. The investigator will never know the identity of the participant.

Eligibility Criteria:
Inclusion Criteria:

* Nurses and physicians

Exclusion Criteria:

* Any person that is not a physician or nurse at St. Elizabeth Youngstown Hospital