cyrilzakka/clinical-trials huggingface dataset:
Myomectomy Operation and Fundus Incision, Energy Modalities and Methods of Extraction

Myomectomy operation due to myoma uteri is an operation that can cause serious blood loss. For some anatomical reasons, fundal myomas were removed, while a group of investigators recommended the initiation of a longitudinal incision and some surgeons preferred a transverse incision. the authors aim to show some surgical differences, intraoperative blood loss, and difficulties and ease of removal of myoma in patients with these approaches without consensus. It is also noted that the incision made with the same energy modality is recorded; The effect of energy modality on blood loss and surgical comfort will be examined. Different approaches are used for laparoscopic surgical operations in order to remove myoma from the abdomen. It can be removed from the vagina by colpotomy and can also be minimized in the abdomen by a morselator. In particular, patients with vaginal myoma removed, such as complaints of postoperative dyspareunia will be followed. In this way, the investigators aim to evaluate the methods which have not yet gained clarity in the literature or have not proven superiority to each other.


Eligibility Criteria:
Inclusion Criteria:

- Patients operated with the diagnosis of myoma uteri

Exclusion Criteria:

* Cardiopulmonary diseases such as cardiac insufficiency, myocardial infarction, unstable angina, acute or new vascular thrombosis, asthma or pulmonary obstructive disease;
* Patients with long-term Trendelenburg contraindications;
* Previous pelvic or abdominal radiation therapy; or those with inadequate bone marrow, kidney and hepatic function;
* Gynecological malignancies.
* Those who received preoperative medication due to myoma uteri
Evaluation of a New Communication Aid Tool to Favor Global Patient Centered Care

PARKINSUN is a new communication aid tool, expected to favor global patient centered care for PD patients during consultation with GPs and neurologists. Two groups of patients will be randomized to use or not PARKINSUN when they consult their physicians every 3 months during 7 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women with all stages of PD
* Without severe chronic neurological or mental or psychiatric pathology
* Absence of cognitive impairment affecting autonomy (MDS criteria of dementia and MOCA \> 22)
* able to come (alone or accompanied) to consultation
* Affiliate or beneficiary of a social security scheme
* Subject having signed informed consent
* Patient willing to comply with all procedures of the study and its duration

Exclusion Criteria:

* Administrative reasons: impossibility of receiving informed information, inability to participate in the whole study, absence of coverage by the social security system, refusal to sign consent.
* Subject under tutelage or curtailer.
* Subject not fluent in the French language to understand the instructions necessary to carry out the cognitive tests.
The Effect of Yoga Self-Practice on Sleep Disturbance

The study will examine the effect of Restorative Yoga self-practice on sleep disturbance in the Chinese adult population. Restorative Yoga is a relaxation-focused yoga style which includes a series of static stretching poses and mindful breathing. Existing literature has demonstrated that face-to-face yoga sessions of different types are effective in improving sleep disturbance and reducing the severity of insomnia. There were pilot studies conducted on the effect of yoga on cancer patients' sleep quality, but research that focuses on insomnia population is rare (Wang et al., 2020). In addition, there is very limited research on the effectiveness of self-practice without the presence of a yoga instructor. Given the social distancing policy under COVID-19 and the need to stay home, this study can shed light on whether self-practice at home can be an effective alternative to face-to-face yoga sessions.

This study will be a pilot randomized controlled trial on the effectiveness of restorative yoga self-practice for sleep disturbance. Prior to all study procedures, online informed consent (with phone support) will be obtained from potential participants. Around 30 eligible participants will be randomly assigned to either the yoga group (intervention group) or the waitlist control group in a ratio of 1:1. The randomization will be performed by an independent assessor using a computer-generated list of numbers. No deception is necessary.

Participants in the intervention group will receive links to two 60-min videos per week for 8 consecutive weeks. Each video will include a yoga practice guided by a certified yoga instructor. The intervention group is required to perform the yoga practice at least two times per week. If preferred, they can do additional sessions with the videos and record their total hours of self-practice. The waitlist control group will receive the video links subsequent to the 8-week study. The intervention group will complete a set of online questionnaires before the intervention commences, weekly during the intervention period, immediately after the intervention, and 4 weeks after the intervention. The waitlist control group will complete the same set of online questionnaires before the intervention commences and immediately after 8-week intervention period has ended.

Eligibility Criteria:
Inclusion Criteria:

1. Hong Kong residents aged 18-59 years;
2. Cantonese language fluency;
3. A global Insomnia Severity Index (ISI) score of 10 or higher;
4. No yoga experience within the 6 months before the study; and
5. A willingness to provide informed consent and comply with the trial protocol.

Exclusion Criteria:

Participants were excluded if they

1. are pregnant;
2. are having unsafe conditions and are not recommended for restorative yoga by physicians;
3. have major psychiatric, medical or neurocognitive disorders that make participation infeasible or interfere with the adherence to the yoga practice;
4. have insomnia due to specific medical conditions, side effects of medication intake or other sleep disorders; and
5. are shift workers.
Pragmatic Cluster Trial for Nursing Home Antipsychotic Prescribing

Two arm, pragmatic, cluster-randomized trial, with nursing homes allocated to the full, active intervention (featuring educational outreach offered to each prescriber and team members in the home) or standard quality improvement supports (including online audit and feedback reports for each prescriber in the home). The 'standard' quality improvement supports represent 'usual care' as these are to be launched province-wide; a concurrent control arm with no exposure to a quality improvement intervention is not feasible.

The Ministry of Health and Long-Term Care and Ontario Medical Association have initiated a project aiming to improve appropriateness of prescribing in long-term care facilities (aka nursing homes) through integrated educational supports for nursing home prescribers, inter-professional care teams, as well as residents and family members. The first focus of the project is appropriate prescribing of antipsychotic medications. Working with Health Quality Ontario, the policy makers have determined that all prescribers will have the opportunity to review practice reports detailing their prescribing performance for this class of medication (aka audit and feedback).

The primary question of this pragmatic, cluster-randomized trial is: What is the effect of adding educational outreach compared to the 'usual' quality improvement supports (i.e. audit and feedback) on prescribing of antipsychotic medications in long-term care?

Secondary questions include the following:

i. What is the effect of the intervention on acute care utilization (e.g., emergency room) rates? ii. What is the effect of the intervention on incidence of patient clinical outcomes and/or adverse effects associated with antipsychotic medications (e.g., falls, aggressive behaviours)? iii. What is the effect of the interventions on medications that might be used as alternatives to antipsychotic medications (e.g., benzodiazepines)? iv. What is the cost-benefit, focusing on prescribing outcomes?

Process evaluation questions include the following:

1. How and why do the interventions work as observed?
2. Was the intervention implemented as desired in nursing homes?
3. What were the contextual factors associated with implementation?
4. Do the interventions affect precursors of behaviour (e.g., motivation, capability)?

Eligibility Criteria:
Inclusion criteria:

* Nursing homes within pre-determined regions of Ontario that expressed an interest in the full intervention (the regions, or hubs, contain a wide variety of nursing home types within a reasonable travel distance \[i.e., \<100 km\])
* Nursing homes within the hubs in which the medical and administrative leads agree to and support the project

Exclusion criteria:

* Nursing homes with a previous or ongoing involvement in externally supported quality improvement initiatives focusing on antipsychotic medications
* Nursing homes without any prescribers caring for at least 10 residents routinely
* Nursing homes with fewer than 30 residents
Fatigue in Chronic Haemodialysis Patients: an Experience Sampling Method Study

To investigate the course and diurnal change of fatigue symptoms and haemodialysis related symptoms in chronic haemodialysis patients, its relation to haemodialysis treatment and the association with other factors by implementing an ecological momentary assessment procedure incorporated in a webapplication.

The course and diurnal change of fatigue symptoms in the daily life of chronic haemodialysis (HD) patients, its relation to haemodialysis treatment and the association with other factors such as mood, activities, location and social context will be evaluated during 7 consecutive days by using an ecological momentary assessment (EMA) procedure, incorporated into a webapplication. Using an EMA procedure will more accurately represent fatigue symptoms and its relation to other factors in the daily life of chronic HD patients compared to conventional measurement instruments (i.e. questionnaires evaluating fatigue over a period of a week or more, which are therefore liable to a recall bias).

Eligibility Criteria:
Inclusion Criteria:

* End stage renal disease requiring chronic haemodialysis treatment currently being treated for at least 6 months.
* Good understanding of Dutch based on clinical judgment (since the web-application is only available in the Dutch language).

Exclusion Criteria:

* The participant cannot independently handle the web-application based on clinical judgment.
* Dementia or insufficient cognitive skills to handle the web-application based on clinical judgement by the attending physician.
Evaluation of Optimal Dose of Local Anesthetics for Patient Controlled Continuous Femoral Nerve Block

To evaluate an analgesic effect without basal administration of local anesthetics for patient-controlled femoral nerve block (with sciatic nerve block) after total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* patients older than 20 yrs old scheduled for total knee arthroplasty

Exclusion Criteria:

* none
Efficacy and Safety of Ixekizumab in Patients with Refractory Guttate Psoriasis

The goal of this clinical trial is to analyse efficacy and safety of ixekizumab in participants with refractory guttate psoriasis. The main question it aims to answer is:

What percentage of participants achieved more than 90% reduction from baseline in Psoriasis Area Index （PASI 90） after 12 weeks of ixekizumab treatment? Participants will receive a 12-week treatment of ixekizumab, with follow-up visits every 2 weeks during the treatment period. Keep a diary of their symptoms and Psoriasis Area Index.

This study was a single-arm, open-label, single-center multi-dose trial. Approximately 50 participants are scheduled to receive subcutaneous injection of ixekizumab for 12 weeks, with follow-up every 2 weeks during the treatment period. After the treatment period, the primary endpoint was assessed at week 16, and patients who achieved PASI 90 response were followed up at week 34 and week 52 to the medical center to assess disease recurrence or progression. To evaluate the efficacy of ixekizumab in the treatment of refractory guttate psoriasis.

Eligibility Criteria:
Inclusion Criteria:

1. Patients voluntarily participate in the study and sign an informed consent form;
2. Age between 18 and 70 years, both genders are eligible;
3. Clinically diagnosed with guttate psoriasis;
4. Previously treated with traditional therapies for plaque psoriasis for more than 4 weeks (including antibiotics, topical corticosteroids, topical calcipotriene, phototherapy);
5. Current PASI score ≥ 3 or DLQI score ≥ 6;
6. Investigator assesses participants's suitability for treatment with ixekizumab;
7. No prior use of biologic agents for treatment;
8. Basic understanding of the purpose of the trial, its effects, and potential adverse events, and willing to sign the informed consent form according to the principles of the Helsinki Declaration;
9. Agree to receive regular treatment, follow-up, and undergo relevant examinations according to the clinical research protocol.

Exclusion Criteria:

1. Presence of other psoriasis phenotypes such as plaque, pustular, erythrodermic, or psoriatic arthritis;
2. Concomitant severe skin diseases, tumors, other systemic diseases (such as inflammatory bowel disease), or mental disorders;
3. Concurrent infections such as tuberculosis, HIV, hepatitis B, hepatitis C, etc.;
4. Allergy to ixekizumab;
5. Received systemic corticosteroids or immunosuppressive/immunomodulatory drugs for psoriasis treatment within the previous 4 weeks (including but not limited to methotrexate, cyclosporine, acitretin, azathioprine, hydroxychloroquine, apremilast, JAK inhibitors, etc.);
6. Participation in another clinical trial within the past 3 months;
7. Pregnant, lactating women, or those planning to become pregnant during the trial;
8. Other circumstances deemed inappropriate for inclusion by the investigator.
Effect of Short-term Simulated Altitude Exposure on Cardiopulmonary Functional Capacity

To determine if exposure of older volunteers, age 50-70y, who are healthy, but not physically active, to 7 days of mild hypoxia (15% oxygen, equivalent 2440m) will improve cardiopulmonary functional capacity.

Background There is an urgent need to reduce morbidity and mortality following major surgery. Bodily demands for oxygen increase after major surgery, and postoperative outcomes can be predicted by quantifying the body's ability to meet increased mitochondrial demand for oxygen using cardiopulmonary exercise testing (CPET).

Design This is a preliminary, physiological study to establish the baseline relationship between mild hypoxia exposure and cardiopulmonary function. This study will begin to examine the feasibility and potential for achieving risk modification through low-oxygen (hypoxic) conditioning, in which a safe and convenient "dose" of mild hypoxia is used to improve CPET derived variables that predict mortality following surgery.

The study will use a randomised, double blind, sham-controlled, crossover design. After a baseline CPET test, participants will be exposed to 7 days of either mildly hypoxic or normoxic air. A follow up CPET test will then be used to determine if cardiopulmonary functional capacity increased after exposure. After a two week washout period, participants will return for a second 7-day session where the alternate exposure will be given. A final follow-up CPET test will then be performed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female individuals aged 50-70 years with sedentary lifestyles.

Exclusion Criteria:

* Known intolerance to altitude identified by the participant's clinical examination, history and pre-altitude screening completed by the research clinician.
* Non-availability and/or suitability to complete the required residential period within the altitude centre.
Cognitive Profile of Patients at the Sagol Center for Hyperbaric Medicine and Research

In the investigator's institute there is ongoing treatment of different patients with cognitive deficits using Hyperbaric oxygen therapy (HBOT). These patients undergo neuro-cognitive function computerized tests before and after treatment.

The aim of this study was to retrospectively evaluate the cognitive changes before and after HBOT in different patients populations.

Retrospective analysis of patients suffering from chronic neuro-cognitive deficits due to different conditions, treated at Sagol center for hyperbaric medicine and research, Shamir (Assaf Harofeh) Medical Center, Israel

Patients included if they had at least two neurocognitive tests, before and after Hyperbaric Oxygen Therapy (HBOT). The study was approved by the institutional review board of the hospital.

Patients were treated with 40-60 daily hyperbaric sessions, 5 days per week. Each session consists of 90 minutes exposure to 100% oxygen at 1.5-2 ATA.

Eligibility Criteria:
Inclusion Criteria:

* Patients included if they completed at least two neuro-cognitive computerized tests, before and after HBOT

Exclusion Criteria:

* Patients who were not able to complete two cognitive tests
Coronary Artery Disease Severity in Newly Diagnosed Dysglycemia

This cohort study will measure how severe is the coronary artery disease (CAD), at time of CAD diagnosis, clinically and angiographically in the different cohorts of newly diagnosed diabetes and prediabetes versus normal glycemia patients in the study center.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients with consents.
* First time diagnosis of CAD and no prior diagnosis of diabetes milletus (DM), or prediabetes.
* Coronary artery disease confirmed by invasive coronary angiography.

Exclusion Criteria:

1. Patients with known significant anemia, increased hemoglobin turnover, active hemoglobin drops or on erythropoietin therapy.
2. Pregnant and post-partum patients (up to 3 months post-delivery).
3. Patients with severe chronic renal failure (estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.72 m2).
4. Patients on any medications with glucose lowering effects.
A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY 1142524 in Patients After Acute Myocardial Infarction With Left-ventricular Dysfunction

The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period in patients with left-ventricular (LV) dysfunction after myocardial infarction (MI). BAY1142524 or placebo will be given on top of evidence-based standard of care for left-ventricular dysfunction after myocardial infarction. Primary objective is the analysis of first signs of efficacy as determined by favourable changes in functional parameters of adverse cardiac remodelling (i.e. endsystolic and enddiastolic volume index, ejection fraction). Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. 30 patients have to complete treatment with verum and 30 patients have to complete treatment with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patients with first ST elevation myocardial infarction (STEMI) treated with primary percutaneous intervention (PCI) or thrombolysis within 24 hours after symptom onset
* Diagnosis of STEMI requires the presence of the following three criteria:

  * Typical clinical symptoms such as chest pain, shortness of breath for more than 20 minutes related to the myocardial infarction
  * New ST elevation indicating myocardial infarction
  * Significant elevation in troponin T or I with at least one value above the 99th percentile upper reference limit (URL) and/or elevation creatine kinase (CK) and creatine kinase MB (6-10% of total CK)
* At the screening period, on day 5 to 9 after MI, patients have to have a LVEF ≤ 45% and an infarct size \>10% LV mass (as measured by LGE-MRI, central-blinded evaluation)

Exclusion Criteria:

* Contraindication to perform contrast-enhanced cardiac MRI
* LVEF \< 20%
* History of heart failure or LVEF \< 50% before occurrence of the first STEMI
* Infarct size \> 45% (g/g; LV mass) between 5 and 9 days after myocardial infarction
* NYHA (New York Heart Association) class IV at randomization
* Any planned cardiac intervention after baseline MRI or any other planned operations
* Non-ischemic causes for cardiomyopathy
* Diagnosis of atrial fibrillation
* Systolic blood pressure \< 100 mm Hg or \> 180 mm Hg; diastolic blood pressure \< 50 mm Hg or \>110 mm Hg, heart rate \< 50 or \>100 beat/minute; mean of triplicate values at randomization
* Clinically relevant hepatic dysfunction
A Phase II Study of 250-mg ZD1839 Monotherapy in Recurrent or Metastatic or Both Recurrent and Metastatic Squamous Cell Carcinoma

The purpose of this study is to find out what effects (good and bad) ZD1839 has on one's squamous cell head and neck cancer. The research is being done because currently no effective treatment exists for metastatic (spread of cancer cells from one area of the body to another) or recurrent squamous cell cancer of the head and neck. The purpose of this study is to find out if ZD1839 can shrink tumors or cause tumors to stop growing for a period of time.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed squamous cell carcinoma of the head and neck incurable by surgery or radiation
* Patients must have measurable disease, defined as at least on e lesion that can be accurately measured in the one dimension (longer diameter to be recorded) as greater then or equal to 20mm with conventional techniques or as greater than or equal to 10mm with computed tomograpy (CT) scan.

Therapeutic history that includes the Following:

* No prior EGFR-based therapy for recurrent disease
* No chemotherapy or irradiation with the 28-day period preceding entry to the study
* Eastern Cooperative Oncology Group (ECOG)performance Status 0-2 (kamofsky \>59%)

Patients must have normal organ and marrow function as defined below:

* leukocytes \>3,000ml
* absolute neutrophil count 1,500/ml
* platelets 100,000/ml
* total bilirubin within normal institutional limits
* AST(SGOT)ALT(SGPT) \<2.5 X institutional upper limits of normal
* Creatinine \<1.5

Exclusion Criteria:

* Other coexisting malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical in situ.
* Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, ketoconazole, erythromycin, clarithromycin, atorvastatin, cimetidine, ametidine, amitriptyline, imipramine, verpamil, tamoxifen, chlorpromazine, amiodorone, chloroquine, St. John's Wort
* Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
* Incomplete healing from previous oncologic or other major surgery Patients may not be receiving any other investigational agents
* History of allergic reactions attributed to compound of similar chemical or biologic composition to ZD 1839
* Uncontrolled intercurrent illness
* Pregnancy or breast feeding (women of child -bearing potential