cyrilzakka/clinical-trials huggingface dataset:
ICSI Versus Conventional IVF in Couples With Non-severe Male Infertility

A multicenter, parallel-controlled(1:1 treatment ratio), open-label, randomized clinical trials regarding fertilization and pregnancy outcomes between ICSI and conventional IVF among couples with no-severe male-factor infertility in China.

A multicenter, large-scale, randomized controlled clinical trial will enroll 2,346 couples with non-severe male infertility undergoing their first or second cycle of IVF or ICSI. The study will recruit participants from 6 Reproductive Medical Centers across mainland China.The participation in this study will be approximately 2 years with a total of 7 visits from controlled ovarian hyperstimulation, pregnancy to delivery. On the day of oocyte retrieval, eligible participants will be allocated to two groups at a ratio of 1:1- ICSI protocol, and conventional IVF protocol. All participants will be randomized through stratified block randomization according to the study sites.

Eligibility Criteria:
Inclusion Criteria:

* Infertile couples scheduled for their first or second IVF/ICSI cycle.
* Men with non-severe male infertility: Sperm concentration 5,000,000-15,000,000/ml or sperm with progressive motility (type A+B) 10-32%.
* Women received either gonadotrophin-releasing hormone agonist protocol or gonadotrophin-releasing hormone antagonist protocol as their controlled ovarian hyperstimulation treatment.
* Informed consent obtained.

Exclusion Criteria:

* Couple with contraindication for IVF or ICSI.
* Couples receiving donor sperm or donor eggs.
* Couples undergoing PGD and PGS.
* Sperm concentration with progressive motility used for insemination \<100,000/ml on the day of oocyte retrieval.
* Women with 0 oocytes after oocyte retrieval.
* Using frozen semen.
* Poor fertilization in previous cycle (≤ 25%).
Metformin for the Prevention of Oral Cancer in Patients With Oral Premalignant Lesions

This phase I trial tests whether metformin works in reducing the annual transformation (development of invasive cancer) of oral precancerous lesions into cancerous lesions. Metformin is a drug approved for the treatment of diabetes, but studies have shown that it may have some anticancer properties. Giving metformin may help prevent or slow the development of oral cancer from precancerous lesions.

PRIMARY OBJECTIVE:

I. To evaluate the transformation-free-survival in lesion types erythroplakia (EP) and verrucous hyperplasia (VH). 'Transformation' is defined as the development of invasive cancer.

SECONDARY OBJECTIVE:

I. To evaluate the current spontaneous regression rates, i.e., percentages of patients having lesion disappear within 1-year post treatment, in all four lesion types and compare them with historical documented regression rate in literature.

EXPLORATORY OBJECTIVE:

I. To evaluate the transformation-free-survival in lesion types homogenous leukoplakia (HL) and non-homogenous leukoplakia (NHL).

OUTLINE:

Patients receive metformin orally (PO) once daily (QD) on days 1-3 and then PO twice daily (BID) for up to 12 months in the absence of unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-85
* Clinical appearance of lesion

  * Homogenous leukoplakia
  * Non- homogenous leukoplakia
  * Erythroplakia
  * Proliferative verrucous leukoplakia
* Histologic appearance

  * No dysplasia
  * Mild dysplasia
  * Moderate dysplasia
  * Severe dysplasia
* Diabetics: if on metformin, will get them to 2000 mg per day, if not, will add metformin in consultation with endocrinologist
* All subjects must be able to comprehend and sign a written informed consent document
* Willing and able to be available for the duration of the study
* In general good health with no contraindication to biopsy or metformin therapy
* Laboratory results

Exclusion Criteria:

* Carcinoma in-situ, verrucous carcinoma, invasive squamous cell carcinoma (SCCa)
* Exclude systemic causes of the lesion: pemphigus, pemphigoid, systemic lupus erythematosus (SLE), lichenoid drug reaction, human immunodeficiency virus (HIV), syphilis
* Exclude local inciting factors: rule out (r/o) but allowing 2 weeks to pass and see if there is resolution, if not and doesn't resolve with local measures, medical treatment, enroll

  * Frictional: sharp tooth
  * Trauma
* Immunosuppression by natural illness or medically induced
* Hypersensitivity or allergic reaction to metformin or some other contraindication
Spinal Cord Stimulation Pioneering Analgesia for Resilient Recovery in Post Intra-Thoracic Surgery Pain

This study aims to determine the effectiveness of spinal cord stimulation in patients with post intra-thoracic surgery pain syndrome in a placebo-controlled, crossover, randomized clinical trial.

Post intra-Thoracic surgery Pain Syndrome (PTPS) is a debilitating condition marked by persistent neuropathic pain in the surgical incision area for at least 2 months after the initial procedure. Proper pain control is instrumental in allowing patients to ambulate and breathe normally, without the need for splinting, and to take deep breaths necessary for effective coughing. The most common surgeries leading to PTPS are video-assisted thoracoscopic surgery (VATS) and (open) thoracotomy. The prevalence of PTPS has been reported between 5-70%, underscoring the high risk of severe chronic postoperative pain associated with thoracic surgery. Spinal cord stimulation (SCS), known for its efficacy in neuropathic pain of any origin, emerges as a potential solution. SCS can be regarded as an effective, safe, well-tolerated, and reversible treatment for severe drug-refractory neuropathic pain. While chronic pain guidelines strongly recommend SCS for certain conditions, such as persistent pain following spinal surgery, it is not typically listed as an option for PTPS. SCS appears promising for treating PTPS, particularly when a patient is resistant to other treatments and driven by neuropathic mechanisms. The potential for sustained pain relief, improved quality of life, and the prospect of reducing or discontinuing medication suggest that SCS may significantly impact the daily lives of individuals suffering from PTPS. This study aims to determine the effectiveness of SCS, which involves the placement of an implantable pulse generator connected to electrodes with leads that stimulate the spinal cord, in patients with PTPS. The hypothesis is that SCS leads to a reduction from baseline in the severity of pain in the Numeric Rating Scale (NRS) score, as well as an improvement in quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of post intra-thoracic surgery pain syndrome
* Medically fit for neurosurgery
* Informed consent

Exclusion Criteria:

* Previous spinal cord stimulation
* Uncontrolled psychiatric comorbidities and substance abuse
* Electrical or other devices that preclude implantation of a spinal cord stimulator device
* Lack of informed consent
Testing the Effectiveness of a Parent and Child Mindfulness-Based Intervention for Child Venipuncture

This study investigates the impact of mindfulness-based intervention for children undergoing a blood-draw and their accompanying parent on (a) child ratings of pain and fear, (b) parent and child ratings of parent distress, and (c) parent perceptions of child pain and fear. Half of the parent-child pairs will receive the mindfulness-based intervention, while half will receive an unfocused-attention task to serve as a comparison with no active component.

To date, there are no randomized controlled trials (RCT) involving a mindfulness intervention for pediatric acute pain. Moreover, this will be the first study to investigate a parent mindfulness intervention in the context of child acute pain. Within a randomized control trial, the objectives of this study are to test the effectiveness of a mindfulness-based intervention for children undergoing a venipuncture and their accompanying parent on (a) child ratings of pain and fear, (b) parent and child ratings of parent distress, and (c) parent perceptions of child pain and fear. Participants will complete questionnaires immediately before and after child venipuncture. This study aims to offer a novel intervention that may improve both parent and child experience during a stressful situation in which parent and child unmanaged distress has deleterious effects. The long-term objectives of this line of research are to improve extant pain management interventions for children undergoing needle-pokes or other painful procedures.

Moderator Aims: To identify possible moderators of a differential treatment outcome (parent and child responses during the needle-poke). These psychological factors include parent and child state catastrophizing, trait experiential avoidance, and trait mindfulness which will be investigated as moderators of the impact of experimental group on the primary outcomes of child self-reported pain and fear, and secondary outcome of parent self-reported distress.

Eligibility Criteria:
Inclusion Criteria:

* Proficiency in English

Exclusion Criteria:

* Major developmental delays in child
Y90 Radiation Segmentectomy vs SBRT for HCC

The proposed study is a single site, prospective, randomized pilot study to assess the feasibility of recruitment of patients into a trial evaluating the efficacy and tolerability of selective transarterial Y90 radioembolization (radiation segmentectomy) versus stereotactic body radiation therapy (SBRT) for solitary early stage (≤ 3cm) hepatocellular carcinoma (HCC).


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and HIPAA authorization
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged ≥ 18 years at time of informed consent
* Solitary HCC (≤3 cm) diagnosed by imaging (LI-RADS 4-5) or histology
* Childs-Pugh score ≤ 7
* ECOG performance status 0-1
* Tumor location/characteristics eligible for either SBRT or Y90 therapy as deemed by local tumor board
* Adequate organ function defined as:

  1. serum bilirubin \< 4.0 mg/dL ,
  2. albumin \> 2 g/dL

Exclusion Criteria:

* Any prior locoregional therapy to the target tumor
* Any prior radiation therapy to the liver
* Pregnancy or lactation: Women of childbearing potential must have a negative pregnancy test within 14 days of protocol registration. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria:

  i. Has undergone a hysterectomy or bilateral oophorectomy; or ii. Has been naturally amenorrheic for at least 24 consecutive months
* Known severe allergic reaction (anaphylaxis) to iodinated contrast
* Coagulopathy (platelets \< 50 K/mm3 and/or INR \> 2) not correctable by transfusion
* Macrovascular invasion or extrahepatic HCC
Effect of Diacylglycerol Oil on Risk Factors of Type 2 Diabetes and Complicating Disease, and Mechanism

Diacylglycerol oil has been shown to lower postprandial and fasting serum triacylglycerol levels and reduce body fat. The investigators hypothesize that replacing dietary fat with diacylglycerol oil reduces excess body fat in type 2 diabetic patients and that diacylglycerol oil has a beneficial effect on cardiovascular risk factors in Chinese type 2 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetic patients, blood sugar levels were stabilized between 7.0-10.0 mmol/L
2. Male, aged 40 - 70 years old, Female, aged post-menopausal - 70 years old.
3. Overweight/obese patients (BMI 25 - 40 kg/m2)
4. Currently under diet therapy for diabetes mellitus
5. Understands the procedures and willing to participate in the study

Exclusion Criteria:

1. Patients who unwilling to give informed consent
2. Type 1 diabetic patients
3. Familial hyperlipemia patients or blood triacylglycerol concentration \> 400 mg/dl
4. Patients with a history of cardiovascular disease and/or arteriosclerotic disease
5. Patients with a history of cerebrovascular disease
6. Patients with serious hepatic disease and/or renal disease
7. Patients with malignancy
8. Participation in another clinical study within 30 days prior to screening period.
9. Has a condition the doctor in charge believes would interfere with evaluation of the subject, or may put subject at undue risk
Korean Study on Safety and Effectiveness of OAD Triple Therapy in Type 2 Diabetes

A multicenter, prospective, non-interventional observation study to evaluate the safety and effectiveness of OAD triple therapy in Korean Type 2 diabetic mellitus patients.

The study was designed as a multicenter, prospective, non-interventional, observational study in patients with type 2 diabetes mellitus who had inadequate glycemic control with conventional combination oral hypoglycemic agents including metformin.

Participants in this study will have type 2 diabetes mellitus with insufficient glycemic control on conventional combination therapy with a DPP-4i or SGLT2i oral hypoglycemic agent, including metformin, requiring the addition of one of the following: SGLT-2i, DPP-4i, or TZD.

The 3-drug combination therapy will be prescribed to subjects based on the medical judgment of the investigator based on the licensure of SGLT-2i, DPP-4i, or TZD(efficacy, dosing, precautions for use, etc.) in a real-world practice setting and all treatment and observation, including administration of medications and laboratory tests, will be based on the medical judgment of the investigator.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with type 2 diabetes who are 19 years of age or older at the time of enrollment.
2. Continued DPP-4i or SGLT-2i oral hypoglycemic combination therapy with metformin for at least 8 weeks prior to enrollment.
3. 7.0% ≤ HbA1c \< 10.0% based on laboratory tests performed within 4 weeks of enrollment.
4. Voluntarily give written informed consent after being told about the study.

Exclusion Criteria:

1. Patients with type 1 diabetes and secondary diabetes.
2. Patients receiving concomitant therapy with 3 or more oral hypoglycemic agents within 8 weeks of enrollment.
3. Requiring treatment with insulin, GLP-1, etc. in addition to oral hypoglycemic agents during the study.
4. End-stage renal disease and hemodialysis patients.
5. diabetic ketoacidosis Patients.
6. Pregnant and lactating women.
7. Patients who are contraindicated by any of the "Precautions for Use" in the license for the drug being administered during the study, given the observational nature of the study under routine practice.
8. Patients with a history of hypersensitivity to the investigational drug or any of its components or excipients.
9. Anyone else deemed by the investigator to be unsuitable for participation in the study.
Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19

The coronavirus disease 2019 (COVID-19) is an emerging pandemic in 2020 caused by a novel coronavirus named SARS-CoV2. Diabetes confers a significant additional risk for COVID-19 patients. Dipeptidyl peptidase 4 (DPP-4) is a transmembrane glycoprotein expressed ubiquitously in many tissues. In addition to its effect on glucose levels, DPP-4 has various effects on the immune system and several diseases, including lung diseases. This trial aims to assess the safety and efficacy of linagliptin, a DPP-4 inhibitor, in the treatment of COVID-19. The trial will be randomized without blinding, with one are treated by insulin only for glucose balance and the other by insulin and linagliptin. The trial will assess the effects of linagliptin on different measures of COVID-19 recovery.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. History of or type 2 diabetes mellitus or a diagnosis of type 2 diabetes during hospitalization.
3. Confirmation of infection with SARS-CoV-2 by PCR testing.
4. Patients within 10 days from symptom onset or patients within 48 hours after laboratory diagnosis (SARS-CoV-2 PCR).

Exclusion Criteria:

1. WHO COVID-19 Ordinal Scale for Clinical Improvement ≥ 6.
2. Respiratory failure requiring mechanical ventilation prior to randomization.
3. Use of vasopressor or inotropic medications prior to randomization.
4. Intolerance/hypersensitivity to dipeptidyl peptidase-4 inhibitors.
5. Patients expected to require intensive care unit admission or immediate surgical intervention.
6. Participation in another trial assessing any treatment for COVID-19.
7. Current treatment with a DPP-4 inhibitor.
8. Pregnancy.
Comparison of 2 Depth of Sedation Indices in the Intensive Care Unit

In the intensive care unit of the Free University hospital of Brussels, sedated patients are standardly monitored with the Masimo SEDline device to see how deeply a patient is asleep. During this study we want to attach 1 extra device to 30 sedated patients, lying in the intensive care unit. This device, called the NeuroSENSE brain monitor from Neurowave systems, uses a different scale to indicate the ideal depth of sedation. In total, both devices will be hung on a patient for 2 times 35 minutes. At minute 33, a RASS score will be determined in each patient. This score will be determined by talking to the patient or administering a pain stimulus. Based on the reaction of the patient an estimation can be made how deeply a patient is sleeping. Our goal is to find out which device correlates best with the effective clinical state of the patient.

Adequate sedation level is important for patient comfort and safety. As under- and oversedation are common several devices are used that measure the Depth of Anesthesia (DoA). Each device uses its proprietary algorithm to calculate a depth of anesthesia index and each index has its own optimal range. The optimal range for the NeuroSense monitor (NeuroWave Systems inc., Cleveland, OH, USA) is between 40 and 60, while the optimal range for the SEDline monitor (Masimo Corporation; Irvine, CA, USA) is between 25 and 50. When the device indicates a value within these limits, the patient is optimally anesthetized for a surgical procedure. In this study, 30 patients will be monitored simultaneously by both the Neurowave and SedLine devices. The study will determine which device is the most accurate and therefore the most ideal for use in the ICU.

Eligibility Criteria:
Inclusion Criteria:

* Sedated patients hospitalized in ICU of the University Hospital of Brussels
* Patients who are monitored with the SEDline/Masimo monitor
* Patients who receive Remifentanil at a maximum concentration of 0,2 μg/kg/min and propofol with a concentration between 0,5-4,0 mg/kg/h
* Age above 18 years

Exclusion Criteria:

* Patients with facial trauma
* Pregnant patients
* Patients who received muscle re-laxants
* Patients in prone position
* Lack of informed consent from the family
* Patients who are hemodynamically unstable
* Patients with neurotrauma or every other neurologic disorder
* Patients post neurosurgery
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Canagliflozin in Older Children and Adolescents With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the pharmacokinetics (blood levels) and pharmacodynamics (the action or effects a drug has on the body) of canagliflozin in children and adolescents with type 2 diabetes mellitus aged 10 to 17 years (inclusive). Other purposes are to investigate safety and assess the ease of swallowing the tablets.

The participants who meet the eligibility criteria, will receive a single dose of placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) and this will be followed by baseline 24 hour pharmacodynamic assessments. On the next morning participants will receive the first canagliflozin dose and will be discharged home to continue canagliflozin treatment for 13 additional days. There will be 2 treatment groups (8 participants in each): the first group will receive canagliflozin 100 mg daily, the second group will receive either canagliflozin 300 mg or canagliflozin 50 mg daily. The canagliflozin dose for the second treatment group will be determined after the sponsor has evaluated the results from the first 5 participants. On day 14 of treatment the participants will be admitted again for 24 hour pharmacokinetic and pharmacodynamics assessments. The participants will continue to take their normal dose and schedule of metformin during the entire study. The total duration of the study is approximately 50 days.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Type 2 Diabetes Mellitus
* Be on a stable regimen of metformin immediate release (IR) monotherapy of at least 1,000 mg/day for at least 8 weeks before screening
* Able to swallow whole tablets
* Absence of pancreatic autoimmunity
* Participants and their caregivers must agree to perform the fasting fingerstick glucose self-monitoring during the study

Exclusion Criteria:

* History of Type 1 diabetes mellitus
* History of maturity onset diabetes of the young (MODY) and any secondary form of diabetes
* Current clinically significant medical illness e.g., significant pulmonary disease, renal or hepatic insufficiency, uncontrolled thyroid disease
* Systolic or diastolic blood pressure outside the range considered normal for the participant sex, age and height
* For females, participants will be excluded if pregnant
Postoperative Pain Control After Hip Hemiarthroplasty: Intrathecal Morphine vs Periarticular Infiltration of Bupivacaine

Falls are a common problem in elderly people which they have to receive the operation. Hemiarthroplasty is one of the common orthopedics operations. The prompt operation and good pain control will provide the good recovery and outcome. The investigators compare the efficacy of postoperative pain control between Intrathecal morphine 0.1 milligrams (mg.) with the local infiltration of 0.25% Bupivacaine for 20 milliliters (ml.) in patients received hip hemiarthroplasty under spinal anesthesia.

Study process All the patients who assigned the hip hemiarthroplasty without any exclusion criteria will be enrolled in the study and be divided into 3 groups randomly

1. control group : the patients will be received spinal anesthesia with 0.5% Isobaric Bupivacaine and postoperative pain control by intravenous (IV) Patient - control Analgesia (PCA)
2. Morphine group : the patients will be received 0.1 mg. of Morphine added in Isobaric Bupivacaine for spinal anesthesia and postoperative pain control by IV PCA
3. Local group : the patients will be received spinal anesthesia and periarticular tissue infiltration with 0.25% Bupivacaine and postoperative pain control by IV PCA

Data collection

1. Demographic data : age, sex, Body Weight, Body Mass Index (BMI), ...
2. Pain score every 3 hours postoperatively in the first 6 hours and at the 12th hours by visual analogue scoring system
3. Patient global assessment and patient satisfactory visual analogue scoring system at 24th and 48th hour
4. the amount of morphine during 24 and 48 hours postoperative and the time of first dose they received

Eligibility Criteria:
Inclusion Criteria:

* age between 18-90 years
* Co-operative, able to use PCA
* ASA classification 1-3
* no contraindication for Spinal Anesthesia
* patient acceptance for spinal anesthesia
* body weight \> 30 kg.
* BMI between 20-35
* no history of drug allergy, e.g. Local Anesthetics, Paracetamol, etc.

Exclusion Criteria:

* age \> 90 years
* previous Hemiarthroplasty (the same site)
* pathological fracture such as severe infection, bone cancer