cyrilzakka/clinical-trials huggingface dataset:
Diafert for Embryo Selection and Fertility Improvement

Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional study.


Eligibility Criteria:
Inclusion Criteria:

* 1. Women at least 18 years old at the time of informed consent.
* 2. Able to understand and voluntarily sign an Informed Consent form approved by the relevant Independent Ethics Committee (IEC) governing the site.
* 3. First or second fresh Assisted Reproductive Technology (ART) cycle attempt (since last successful implantation, if any).
* 4. Eligible for elective SET of fresh embryo on Day 2/3. Elective SET is defined as a transfer for which there is more than one embryo in the same morphological ("best") category as that of the selected embryo.

Exclusion Criteria:

* 1. Presence or history of ovarian endometriotic cyst.
* 2. Presence or history of diagnosed severe endometriosis (i.e. stage IV the revised American Fertility Society classification for endometriosis).
* 3. Hormonal, functional, anatomical and/or any other abnormalities potentially increasing the risk of miscarriage and/or ectopic pregnancy as judged by the Investigator and determined by medical history and clinical laboratory. This includes, but is not limited to, uncontrolled diabetes mellitus, uncontrolled thyroid disease, alcoholism, drug abuse, abnormal uterine cavity etc.
* 4. History of two or more consecutive miscarriages.
* 5. Known history of human immunodeficiency virus, Hepatitis C virus and/or Hepatitis B virus infection.
* 6. The subject has other serious or acute conditions that, in the Investigator's opinion, would preclude her participation in the study.
* 7. Need for preimplantation genetic diagnosis/screening.
* 8. Use of time-lapse embryo imaging.
* 9. Participating in oocyte donation procedure.
* 10. Participation in any interventional drug clinical investigation within 2 months prior to screening.
* 11. Dependency on sponsor or investigator (e.g. co-worker or family member).
Study of Algorithm for Epilepsy Alert Device

An accelerometer with transmitting ability is worn on the wrist. Data of movements during seizures will be analyzed to upgrade algorithm that will identify seizures.

Patients undergoing Video-EEG telemetry will wear movement sensor on their wrist. The sensor will transmit continuous data to a laptop. Seizures' data (tonic or clonic) will be analyzed and transformed into an algorithm (up-graded existing preliminary algorithm).

In the second phase the algorithm will need to identify seizure events within one minute of the onset.

Both specificity ("false positive") and sensitivity ("false negative) will be than calculated.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing Long Term Monitoring for motor seizures

Exclusion Criteria:

* Invasive recording
* Psychogenic seizures
Lidocaine Patch Versus Intravenous Lidocaine in Pain Relief After Laparoscopy

To evaluate the efficacy of lidocaine patch applied around wound in laparoscopic gynecologic surgery in reduction of postoperative pain and illus compared to intravenous lidocaine infusion and placebo.

Postoperative pain after gynecologic surgery is a challenging problem associated with increased morbidity and cost. The inflammatory response to surgery plays a crucial rule in inducing postoperative illus. Systemic local anesthetics proved to have anti-inflammatory properties that may be beneficial in preventing ileus added to its analgesic actions. The lidocaine patch evaluated in many types of pain with promising results. The study try to evaluate the patch in perioperative field as a more simple and safe technique than the intravenous route.

Eligibility Criteria:
Inclusion Criteria:

* female undergoing elective gynecologic surgery

Exclusion Criteria:

* known allergy to lidocaine,
* respiratory or cardiac dysfunction, arrhythmia, treatment with antiarrhythmic drugs,
* inflammatory bowel disease (Crohn's disease or ulcerative colitis)
* hepatic, renal
* chronic use of analgesics or corticosteroids
The Effects of add-on Anti-diabetic Drugs in Type 2 Diabetic Patients

Recently, there are some new classes of anti-diabetic drugs availible in Taiwan. In this study, we will observe the change in inflammation and energy homeostasis in type 2 diabetic outpatient, who receiving a new anti-diabetic drugs.

Recently, there are some new classes of anti-diabetic drugs availible in Taiwan. However, the effects of these anti-diabetic drugs should be further evaluated. Specially, the effects on inflammation and energy homeostasis are still not well assessed. In this study, we will observe the change in inflammation and energy homeostasis in type 2 diabetic outpatient, who receiving a new anti-diabetic drugs.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic outpatient

Exclusion Criteria:

* Refusal of anti-diabetic drugs
* Preganacy
Analgesic Effect of Ropivacaine Combined With Hydromorphone for CSEA After Total Knee Arthroplasty

The aim of this study is to investigate the continuous analgesic effect and side effects of ropivacaine combined with hydromorphone for combined spinal-epidural anesthesia(CSEA) after total knee arthroplasty and to explore its clinical application value. To observe whether hydromorphone combined with ropivacaine can promote the rapid recovery of patients.

For patients undergoing total knee arthroplasty, different spinal anesthesia drugs were injected in the two groups. The spinal anesthetic drugs injected in the hydromorphone group were hydromorphone 50 μg and ropivacaine 15 mg. In the control group, the spinal anesthetic was ropivacaine 15 mg.The differences in analgesia, sedation, and side effects between the hydromorphone group and the control group were analyzed by collecting various data at different times after anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Age between 55 and 80 years old.
* ASA grade I to III.
* BMI:20-29kg/m2.
* No recent use of sedatives, opioids, or other analgesics.
* There was no contraindication of spinal anesthesia, severe dysfunction of heart, lung and other important organs or serious systemic diseases.
* Patients were willing to participate in the study and signed the informed consent.

Exclusion Criteria:

* The patient has mental illness or cannot cooperate with the completion of spinal anesthesia.
* The patient had a history of spinal surgery and spinal deformity.
* Patients had a history of opioid intolerance or adverse reactions.
* puncture site infection, coagulopathy or recent use of anticoagulant drugs.
* History of allergy to local anesthetics.
* Failed puncture.
* Unable to cooperate to complete the research process.
Bioavailability of Subcutaneous Dexmedetomidine

The aim of this study is to investigate the pharmacokinetics of subcutaneously administered dexmedetomidine in healthy volunteers. The absolute bioavailability of subcutaneously administered dexmedetomidine will be calculated. In addition, the investigators will report the effects of subcutaneously administered dexmedetomidine on plasma catecholamine levels, vital signs such as systemic blood pressure, heart rate and sedation. The investigators will also monitor the local and systemic safety and tolerability of subcutaneously administered dexmedetomidine.


Eligibility Criteria:
Inclusion Criteria:

* Fluent skills in the Finnish language in order to be able to give informed consent and communicate with the study personnel.
* Age ≥ 18 years.
* Male gender.
* Weight ≥ 60 kg.
* Written informed consent from the subject.

Exclusion Criteria:

* Previous history of intolerance to the study drug or related compounds and additives.
* Concomitant drug therapy of any kind except paracetamol in the 14 days prior to the study.
* Existing or recent significant disease.
* History of any kind of drug allergy.
* Previous or present alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements.
* Donation of blood within six weeks prior to and during the study.
* Body weight \< 60 kg or BMI \> 30 kg / m2.
* Participation in any other clinical study involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study.
* Smoking during one month before the start of the study or during the study period.
* Clinically significant abnormal findings in physical examination, ECG or laboratory screening
Intraoperative TIVA With Propofol on Postoperative Pain and Side Effects After Liver Resection Surgery

Postoperative pain can be severe after liver resection surgery. However, postoperative pain management may be difficult for this group of patients. Opioidergic neurotransmission may be altered in cirrhotic patients and selectively increasing receptor affinity for opioids. Large dose of strong opioid may be required to achieve adequate pain control. However, this may not be possible due to the side effect of opioid and liver dysfunction after liver resection.

Propofol is a commonly used anaesthetic with rapid recovery and less side effects and TIVA (total intravenous analgesia) with propofol is a common technique now. The reduction on certain serum pro- inflammatory cytokines may lead to more smooth post- surgical recovery.

Recent case report proved the analgesic effect of propofol infusion. However other animal and clinical studies showed controversial result.

The aim of this retrospective study is to investigate the postoperative analgesic effects and side effects of intraoperative TIVA with propofol in patient undergoing liver resection surgery at Queen Mary Hospital, Hong Kong between 2010 to 2012.

Retrospective audit.

Anaesthetic records and acute pain service records of patient undergone liver resection surgery between 2010 to 2012 in Queen Mary Hospital would be retrieved from the computer.

Data Collection

1. Demographic data;
2. Types of analgesic techniques;
3. Type of pain relief modalities;
4. Pain score up to 72 hours postoperatively;
5. Postoperative opioid consumption;
6. Incidence of adverse events during APS care;
7. Patients' satisfaction on pain relief.

Data Analysis For summarising analysis, mean or median with standard deviation or interquartile range will be reported. Parametric and non-parametric comparative tests will be used for analysis between/among patients with various characteristics. Kaplan Meier survival analysis and log-rank test will be used for duration of APS use.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergone liver resection surgery between 2010 to 2012 in Queen Mary Hospital

Exclusion Criteria:

* Essential data were missing.
* Patient participating in other research projects.
* Changes in postoperative pain management technique.
* Patients could not be assessed post-operatively for pain (i.e. post-operative IPPV)
Web-based CBT for Children With Chronic Pain

The purpose of this study is to develop and evaluate the feasibility and effectiveness of a web-based (i.e., internet) treatment approach for providing psychological treatment to reduce pain and improve functioning in children and adolescents with chronic pain.

Chronic pain is an important problem for children and adolescents owing to its high prevalence rate and significant impact on children's mood, daily functioning, and overall quality of life. Effective psychological treatments have been developed to change behaviors and thoughts important in the child's ability to cope with chronic pain. However, the majority of children do not have access to these treatments due to a variety of barriers such as geographical distance from pediatric pain treatment centers.

The purpose of this study is to develop a more accessible method of delivering effective psychological treatment to reduce pain and increase function in children. Children with chronic headache, abdominal, or musculoskeletal pain will be randomized to either receive the web-based treatment right away or to be in a wait-list control condition and receive the treatment 8 weeks later. Both groups of children will continue to receive clinical care through specialty medical clinics. Children's level of pain, their ability to perform, daily functional activities, and overall quality of life will be evaluated before treatment begins, immediately after treatment, and at a 3 month follow up.

Eligibility Criteria:
Inclusion Criteria:

* chronic headache, abdominal, and/or musculoskeletal pain present over the previous 3 months
* interference from pain in at least one area of daily functioning.

Exclusion Criteria:

* serious comorbid chronic condition in the patient (e.g., diabetes, cancer)
* non-English speaking
* previous participation in cognitive-behavioral therapy.
Gastrointestinal Dysfunction During Enteral Nutrition in Critically Ill Patients

Gastrointestinal (GI) motility disorders in intensive care patients remain relatively unexplored. Nowadays, the frequency, risk factors and complications of GI dysfunction during enteral nutrition (EN) become more questionable. Our aim is to evaluate the frequency, risk factors and complications of GI dysfunction during EN in the first 2 weeks of the intensive care unit (ICU) stay and to identify precautions to prevent the development of GI dysfunction and avoid complications.

Critical illness is typically associated with a catabolic stress state in which patients demonstrate a systemic inflammatory response coupled with complications of increased infectious morbidity, multiple organ dysfunction, prolonged hospitalization, and disproportionate mortality. Suspension of feeding and the resultant inability to reach nutritional goals is one complication of gastrointestinal (GI) dysfunction, but there are others (mucosal barrier disruption, altered motility, atrophy of the mucosa, and reduced mass of gut-associated lymphoid tissue) that may explain the greater length of stay (LOS) and death rate with GI dysfunction. In Europe and the United States, nutritional administration guidelines recommend primarily enteral nutrition (EN) for hemodynamically stable intensive care unit (ICU) patients. Providing EN in these patients has been shown to be superior to parenteral nutrition. GI complications such as constipation, delayed gastric emptying, diarrhea, and vomiting may occur in up to 50% of mechanically ventilated patients and adversely affect ICU mortality and LOS. Nevertheless, there is no consensus for obtaining a precise assessment of GI function.Diagnosis of GI dysfunction in ICU patients is complex and relies on clinical symptoms. Lack of validated markers of GI system dysfunction is often misdiagnosed and poorly managed in the ICU. The role of nutrition in critical illness is important, but there is an increasing evidence and broadening consensus that aggressive early feeding as well as prolonged underfeeding both should be avoided. Avoidance of complications like malnutrition, aspiration of gastric contents, wound infections, and decubitus through GI dysfunction is an important part of management of patients with GI failure.

Eligibility Criteria:
Inclusion Criteria:

Older than 18 years old. Stay longer than 48 hours at ICU.

Exclusion Criteria:

Has enterostomy/colostomy or diagnosis of GI bleeding. Prone position. Laxative drug use. Clostridium Difficile infection positivity.
Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery

This is a prospective, randomized, open-label, blinded-evaluator study that will evaluate the effectiveness of a surgical sealant (CoSeal) composed of biocompatible polyethylene glycol on the formation of mediastinal and pericardial adhesions in children undergoing staged surgical reconstruction (potential procedures include: Blalock-Taussig Type Operation, Classical Glenn Procedure, Bidirectional Glenn Procedure, Norwood). Additionally, bleeding will be evaluated by drainage post-operatively through surgical site drainage output.


Eligibility Criteria:
Inclusion Criteria:

* Have an acceptable surrogate capable of giving consent on the subject's behalf.
* Pediatric patients ages 0 - 17
* Have a cardiac disease which requires staged cardiac surgery and resternotomy
* Non-emergent state or emergent state with sufficient time to educate and consent

Exclusion Criteria:

* An immune system disorder
* Unplanned reoperation
* Known hypersensitivity to components in CoSeal
* Patients undergoing reoperation less than 3 months after the primary surgery
Efficacy of Botulinum Toxin in Temporomandibular Disorders

Temporomandibular disorders (TMDs) represent a multifactorial pathological group that gives rise to a varied and complex symptomatology that includes decreased jaw movement, muscle and joint pain, joint crepitation and limitation or functional deviation of the jaw opening.

All this is sometimes accompanied by headache and other painful symptoms in the neck musculature, incapacitating for many patients and at considerable public health expense. Intramuscular and intra-articular injections of botulinum toxin are a simple treatment that has proven to be effective in the treatment of the painful symptoms of these disorders, being a therapeutic option in situations of failure of conventional treatments, without presenting adverse effects.

Our study presents the preliminary results of twenty patients treated with this therapy

TMDs are a common pathology affecting up to 70% of the population, with a maximum incidence in young patients. We used a sample of twenty patients recruited in the Maxillofacial Surgery Service of the University Hospital of Salamanca (Spain), who met the inclusion criteria, with unilateral painful symptomatology of more than three months duration. All patients were randomly treated by intramuscular and intra-articular injections of BTX (100 U) in 8 predetermined points. Pain symptomatology was assessed at the different locations, together with joint symptomatology, at baseline and 6 weeks after treatment.

Adverse effects were also evaluated. In 85% of the patients, pain on oral opening improved and 90% showed improvement of pain on mastication. A 75% of the patients reported improvement in joint clicking/noise. Headaches improved or disappeared in 70% of the patients treated. Despite the limitations of the study and the preliminary results, intramuscular and intra-articular infiltrations with BTX were effective in the treatment of symptoms associated with TMDs, with minimal adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* The study included patients diagnosed with TMDs, according to the established diagnostic criteria, aged between 18 and 69 years (both included) and with unilateral painful symptomatology of more than three months' duration.

Exclusion Criteria:

* Patients previously treated with surgery/arthrocentesis of the TMJ; patients treated in the last six months with surgery in the cervicofacial region; patients who, at the time of inclusion in the study, were being treated in a "Pain Unit" and patients who had previously received treatment with BTX.
Low-Carb/Time-restricted Feeding Protocol in Insulin-Using Type 2 Diabetics

The current paradigm of Type 2 Diabetes treatment relies heavily on expensive pharmacotherapy even though lifestyle factors are at the root of the condition. This study is designed to assess the feasibility of a low carbohydrate diet coupled with a time restricted feeding intervention to improve participant sensitivity, reducing their need for insulin. 20 participants will be invited to enroll from the 20 S Park St Clinic in Madison, WI and remain on study for up to 6 months.

The investigators will perform a prospective cohort study of 20 insulin-using Type 2 diabetics who have primary care providers at 20 S Park St Clinic. Participants will be recruited from the Internal Medicine practices at the clinic. The subjects will meet with Dr. Zimmermann (Study Clinician) to review time restricted feeding and low-carbohydrate diets as well as a strategy for decreasing insulin doses. Calls from Dr. Zimmermann's clinic nurse will occur daily until blood glucose levels stabilize to manage insulin decrease.

Participants will complete monthly logs of food intake times and meet with a dietician twice during the 6-month study. Diabetes medication use will be reviewed, and hemoglobin A1c will be measured, at baseline and at 3 and 6 months. The participants' non-diabetic medical care will continue to be managed through their primary care physicians (PCPs).

Specific Aims:

* Demonstrate feasibility of the low carbohydrate/time restricted feeding (LC/TRF) protocol

  * Feasibility will be assessed based on participant compliance with time-restricted feeding and recommended carbohydrate intake, clinician time and clinic resources
* Determine effectiveness of the LC/TRF protocol on diabetes care and quality of life

  * Effectiveness on diabetes care will be evaluated using changes in A1c, insulin use, BMI, patient quality of life, and adverse events including hypoglycemia.

Eligibility Criteria:
Inclusion Criteria:

* Patient of a primary care provider at 20 S Park Internal Medicine Clinic
* Insulin using type 2 diabetic
* Using glargine or detemir insulin for basal insulin dosing
* Self-administering insulin
* Hemoglobin A1c 7-10%.
* Stable diabetes regimen for \>3 months
* Demonstrated reliability with glucose monitoring, A1c checks
* BMI 25-35

Exclusion Criteria:

* History consistent with type 1 diabetes
* Using concentrated insulin (U200 or U300)
* Living in a skilled nursing facility
* Unwilling or unable to do frequent (3x daily) blood glucose checks
* eGFR (estimated glomerular filtration rate) \< 30 mL/min per 1.73 m2
* Currently on steroids or warfarin
* Hospitalized within 3 months
* Symptomatic heart failure
* Weight Loss \>10% in last six months
* History of organ transplantation
* Pregnant/trying to become pregnant/breast feeding
Protocol Lab for Online Trial Delphi and Question Effects

This study nested as a randomized controlled trial within an online Delphi and will assess the impact of using different question section groupings to provide aggregate feedback to participants in an online Delphi study.

A similar assessment has been done during the development of a core outcome for critical care trials set with a nested study examining the impact of question order on prioritization of outcomes. Research reports different stakeholders groups may differ in how they value or prioritize research questions and outcomes and it is recommended that each group should be adequately represented.

The Protocol Lab for Online Trials-Delphi (PLOT-D) study will use an online Delphi combined with participatory action research to inform the development of a multi-use protocol template for writing protocols for self-recruited online trials of interventional self-management. The Protocol lab will use the Delphi findings, along with earlier research to redesign a series of protocols for online randomized trials with the aim of providing support for citizens to work alongside researchers to build participatory health trials online.

Eligibility Criteria:
Inclusion Criteria:

* Protocol lab for online trials Delphi (PLOT-D) participants

Exclusion Criteria:

* None if inclusion criteria are met