cyrilzakka/clinical-trials huggingface dataset:
Impact of Timing of Midazolam Administration on Incidence of Postoperative Nausea and Vomiting

Postoperative nausea and vomiting (PONV), defined as nausea and/or vomiting occurring within 24 hours after surgery, affects between 20% and 30% of patients, As many as 70% to 80% of patients at high risk may be affected. The etiology of PONV is thought to be multifactorial, involving individual, anaesthetic and surgical risk factors. PONV results in increased patient discomfort and dissatisfaction and in increased costs related to length of hospital stay. Serious medical complications such as pulmonary aspiration, although uncommon, are also associated with vomiting.

Patients with a higher risk of PONV often require a combination or multimodal approach of 2 or more interventions for effective risk reduction. Thus, researchers have explored additional nontraditional antiemetics, such as midazolam, that would aid in the multimodal prevention of PONV.

Midazolam is often administered in the perioperative period to reduce anxiety in addition to causing sedation and amnesia. The pharmacologic qualities allow for a rapid onset, short duration, and short half-life. The clinical effects of midazolam result from an agonist action on the γ-aminobutyric acid A (GABAA) receptor throughout the central nervous system. Benzodiazepines do not work directly on the GABA receptor, so there is a physiologic ceiling effect, which contributes to their safety and low toxicity.

Although the exact antiemetic mechanisms remain unknown, researchers postulate that midazolam works on the chemoreceptor trigger zone by reducing the synthesis, release, and postsynaptic dopamine. It remains debatable whether midazolam reduces dopamine directly or blocks the reuptake of adenosine leading to an adenosine-mediated reduction of dopamine release. Additionally, the binding of midazolam to the GABA benzodiazepine complex may cause dopaminergic neuronal activity and the release of 5-hydroxytryptamine. The reduction of PONV may also be a secondary effect of the anxiolytic properties of benzodiazepines.

Despite literature demonstrating the PONV benefits of midazolam in the perioperative period, But the timing of administration of this drug is still not well established. As it is known that it has half-life of about 1.5 - 2.5 hours and the controversies remain whether to administer this drug preoperatively or postoperatively to prevent PONV. So this comparative study is designed to know the better time for administration of this drug to prevent PONV and to improve patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Female patients
* aged twenty to sixty years old
* The American Society of Anesthesiologists (ASA) physical status classification grade I or II
* Scheduled for laparoscopic gynecological surgeries under general anesthesia.

Exclusion Criteria:

* Patients who have gastrointestinal disorders,
* histories of PONV after a previous surgery,
* Renal or liver dysfunction,
* history of motion sickness,
* Have received any opioid, steroid, or antiemetic medication in the 24hs before surgery, and
* Pregnant or menstruating women.
Study to Investigate the Potential Drug-Drug Interaction Between ZSP1273 and Oseltamivir

To evaluate the drug-drug interaction between ZSP1273 and oseltamivir, the pharmacokinetic characteristics and safety of ZSP1273 and oseltamivir in healthy subjects, so as to provide a basis for the design of administration regimen in subsequent clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Males and female subjects between 18-45 years (Both inclusive);
* Body weight is no less than 50kg in males and no less than 45kg in females.Body mass index (BMI) 18\~26 kg/m2 (Both inclusive); BMI is determined by the following equation: BMI = weight/height2 (kg/m2);
* Subjects (including partners) are willing to voluntarily use effective contraception from screening to 3 months after the last study drug administration.

Exclusion Criteria:

* Known history of allergic constitution (multiple drugs especially with ZSP1273 or oseltamivir and its preparation of the main ingredient allergy, food allergy);
* Subjects who donated blood or bleeding profusely(\> 450 mL)in the 3 months preceding study screening;
* History or presence of any disease or condition known to increase the risk of bleeding, eg.hemorrhoids, acute gastritis or gastric and duodenal ulcer, etc;
* Use of any prescription or over-the-counter (OTC) medications, vitamins and herbal within 14 days prior to screening;
* Concomitant therapy with any drugs with known hepatic enzyme-inducing or inhibiting agents that may change the activity of drug metabolic enzymes ，is intended to be taken in combination 28 days prior to screening or during the study period；
* Participated in another clinical research study or received any investigational products within 3 months prior to dosing;
* Presence of clinically significant abnormalities in ECG , QTcB\>450ms in males,or QTcB\>470ms in females;
* Any of the following diseases (including but not limited to gastrointestinal, renal, liver, neurological, hematological, endocrine, tumor, pulmonary, immune, psychiatric or cardiovascular and cerebrovascular diseases) that are clinically significant in clinical laboratory examination or other clinical findings within 6 months prior to screening;
* Breast-feeding women or those with positive pregnancy test results;
* Subjects who should not be included in the study in the opinion of the Investigator.
Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study

The purpose of this pilot study is to determine the efficacy and safety of escitalopram administered premenstrually (day 14 through day 2 of the menstrual cycle) for severe PMS in young women ages 15-19 years.

The medication in this study is a serotonin reuptake inhibitor (SSRI), a class that is considered the first-line treatment for severe PMS at this time. Although data indicate that young women who have PMS in their teen years report the same symptoms and symptom severity as adult women, clinical trials have not included this age group, and there is no information on the efficacy and safety of treatment with a serotonergic antidepressant for PMS in teens.

Eligibility Criteria:
Inclusion Criteria:

* Females 15-19 years of age
* Regular menstrual cycles of 22-35 days
* In general good health
* Medically approved birth control method if sexually active
* Evidence of ovulation
* Meeting all symptom criteria for PMS
* Signed informed consent
* Subjects under age 18 must also have signed parental consent

Exclusion Criteria:

* Current use of any treatment for PMS.
* Psychotropic or other medications that may compromise the study drug.
* Pregnancy, intending pregnancy or breast feeding.
* Not using a medically approved birth control method if sexually active.
* Significant medical or gynecological abnormalities.
* Irregular menses, any gynecologic disorder.
* Any severe or unstable medical illness.
* Any current major psychiatric diagnosis or any history of a major psychiatric diagnosis.
* Any current or history of alcohol abuse, drug abuse, suicide attempt, bi-polar disorder, psychosis or severe personality disorder.
* Use of triptans (Imitrex, Zomig, Frova, Maxalt, Axert, Amerge, Relpax).
* Use of medicines that include dextromethorphan such as Tylenol or Vicks cough medicines.
* Use of the pain medication meperidine.
* Use of any herbal product such as St John's Wort that may increase serotonin.
* Use of monoamine oxidase inhibitors (MAOIs), pimozide or citalopram hydrobromide.
* Drugs metabolized by CYP2D6 or a combination of CYP3A4 and CYP2D6 inhibitors.
* Hypersensitivity to escitalopram or citalopram.
Application of Digital Techniques in Intraoral Condylectomy Via Coronoid Process Resection

This study will apply the digital techniques to do the condylectomy through an intraoral approach without needing to do the intraoral vertical ramus osteotomy (IVRO). This new surgical technique will greatly maintain the TMJ anatomy structure, reduce the risk and increase the precision of the operation procedure.

In this study we will use the digital techniques such as pre-surgical visual treatment planning, real time surgical navigation system, endoscope techniques, to do the intraoral condylectomy via coronoid process resection. After the condyle lesion resection, the coronoid process will be reimplanted and fixed by stainless steel wire. By using these techniques we can safely and precisely cut proper size and position of the condyle lesion as we pre-surgically designed, and at the same time greatly maintain the temporomandibular joint anatomy structure. Since we don't need to do the mandible vertical ramus osteotomy, and no conventional extraoral incision will be needed, the surgical injury will be minimized and the TMJ function will recover soon postoperatively. Additionally, the intraoral approach can avoid the risk of facial nerve injury, salivary fistula and skin scar, so it has better aesthetic results than the preauricular approach and the submandibular approach.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mandible condylar hyperplasia or osteoma who need to do the condylectomy to prevent the active growth of the affected mandible condyle and the consequence progressive facial asymmetry
* Usually the patients have TMJ functional disorder; and the SPECT shows difference greater than 20% (pixel count) between the affected side and the contralateral normal side.

Exclusion Criteria:

* Patients with contradictions to do the operation procedure and general anesthesia, patients refuse to accept the condylectomy, or patients can't afford the extra cost for the application of digital techniques are excluded from this study
Neopep-S-based EasyDew MD Regen Cream for Radiotherapy Subject After Breast Tumor Resection

This clinical study is conducted prospectively for 3 months after medical device treatment. It is a comparative clinical study of the leading control group.

Subject is a patient who has a tumor removed from the breast and is receiving radiotherapy at the lesion.

Subjects (and/or legal representatives) have agreed in writing to participate in the clinical study.

Perform a post-screening test. Evaluating the screening test results, meeting the selection criteria, and meeting the exclusion criteria.

Those who do not are registered for clinical research.

* Control group: Physiogel Skin Stability Intensive Cream MD (10 people)
* Study Group: EasyDew MD Regen Cream (20 people) The subjects of the clinical study are randomly assigned in a 2:1 ratio between the study group and the control group.

In this case, apply the control medical device twice a day (morning and evening) to the radiation treatment area.

Apply it. In the case of the research group, easy dew MD Regen Cream was applied to the radiotherapy site.

Apply an appropriate amount twice a day (in the evening) to ensure good absorption.

The progress for three months after the application of medical devices for clinical research will be observed, and the subjects will be screening visit (Visit1), medical device application day (Visit2), medical device application, and medical device application.

Visit the research institution regularly for one month (Visit3) and three months after application (Visit4) for validity and to be evaluated for safety.

Eligibility Criteria:
Inclusion Criteria:

* adults over the age of 19
* The tumor in the breast area is resected and radiotherapy is planned, performed, or Subjects with a history of irradiation
* Decide to participate in this clinical study arbitrarily and in the written informed consent a person to whom

Exclusion Criteria:

* When participating in a clinical study, the findings of radiation dermatitis in the area are shown
* A person who shows signs of acute or chronic dermatological diseases
* In situations where the requirements of a clinical study cannot be complied with
* When the researcher's judgment determines that the participation of the study is inappropriate (e.g. Kelloid personality)
Frailty and Non-Fragile Congenital Heart Disease

Congenital heart disease (CHD) is defined as congenital functional or anatomical abnormalities of the heart and intrathoracic great vessels. This study, which is planned to be carried out, will enable people with CHD to present a holistic perspective when planning rehabilitation programs and to create a common language for all health professionals.

Congenital heart disease (CHD) is defined as congenital functional or anatomical abnormalities of the heart and intrathoracic great vessels. These abnormalities cover a wide range from minimal defects to serious cardiovascular problems. The prevalence of CHD has been reported as one case per 100 live births, with increases in recent years. As a result of surgical and medical advances in recent years, childhood lethal abnormalities in previous years can be significantly alleviated and repaired. As a result of these developments, 90% of patients born with CHD are expected to survive until adulthood, and today the number of adult CHD has exceeded the number of pediatric CHD. The aging CHD population is at risk of cardiovascular disease in addition to chronic problems resulting from congenital abnormalities. Frailty was defined by the Cardiovascular Health Study Collaborative Research Group as a complex clinical syndrome resulting from cumulative declines in more than one physiological system, leading to reduced resistance to risk factors. Loss of strength, decreased physical activity, involuntary weight loss, decreased mobility, and fatigue are sub-parameters of frailty. Frailty causes common pathophysiological mechanisms with risk factors that play a role in the development of cardiovascular disease. Frailty is associated with a higher incidence of cardiovascular disease and risks of all-cause mortality, leading to a reduction in life expectancy. Cardiorespiratory fitness and functional strength are shown to be the strongest predictors of frailty level and the potential for frailty to decrease over time. It has been reported that frailty worsens cognition and activities of daily living in cardiovascular diseases. There is no study in the literature that comprehensively evaluates vulnerability in individuals with CHD. The aim of this study; To assess frailty in individuals with CHD, to compare functional capacity, muscle strength, activities of daily living, and cognition in individuals with and without CHD. This study, which is planned to be carried out, will enable people with CHD to present a holistic perspective when planning rehabilitation programs and to create a common language for all health professionals.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with congenital heart disease
* To be between the ages of 15-45
* To have been informed about the study and given written consent to participate in the study.

Exclusion Criteria:

* Having a neurological, orthopedic or any systemic disease,
* Presence of infection and malignancy,
* Cognitive, psychological and mental status are not suitable for evaluations,
* To undergo another surgery other than cardiac surgery.
Patterns of Relapse After Neoadjuvant Chemotherapy in Breast Cancer

This study aims to identify patterns of relapse after Neoadjuvant Chemotherapy (NAC) for breast cancer to refine follow up recommendations.

Neoadjuvant chemotherapy (NAC) is usually used to facilitate breast-conserving surgery and improve surgical outcomes for breast cancer patients \[1\]. In addition, NAC can help to eradicate micrometastatic disease and serve to test chemosensitivity while providing similar survival benefits to adjuvant chemotherapy \[2-5\] .

Pathologic complete response (pCR) after neoadjuvant chemotherapy is associated with superior survival outcomes, with higher rates of pCR in human epidermal growth factor receptor 2 positive (HER2+) and triple negative breast cancer (TNBC) subtypes compared to hormone receptor (HR)-positive subtypes \[6-7\] .

Patients who achieve pCR also remain at signifcant risk of relapse, with studies reporting 5-year disease-free survival (DFS) rates of 75-87% \[2,8-10\] . Retrospective study of 88 Japanese patients who achieved pCR reported a recurrence rate of 13.6% and all relapses occurred within 32 months from diagnosis \[11\].

There for, little is known about the patterns of relapse after NAC especially in the real world. There are currently no specific guidelines for post-treatment follow-up of patients treated with NAC and variations in practice exist. So, this study aims to evaluate the relapse risks in different subgroups of breast cancers treated with NAC and determine the associated time trends and patterns of relapse in these patients. These findings may potentially lead to the development of risk-adapted surveillance strategies for patients treated with NAC

Eligibility Criteria:
Inclusion Criteria:

1. Female patients aged \>= 18
2. Pathologically proved breast cancer
3. PS 0-1 (ECOG)
4. Patients indicated to receive NAC

Exclusion Criteria:

1. Patients with metastatic disease at diagnosis
2. Patients who did not undergo subsequent curative intent surgery
3. Those who received Neoadjuvant hormonal treatment
4. Those that had incomplete treatment information
Efficacy and Safety of Topical Diclofenac Combined With Oral Diclofenac in the Treatment of Knee Osteoarthritis

Oral non-steroidal anti-inflammatory drugs (NSAIDs) are a recommended treatment for the symptoms of osteoarthritis of the knee. However, NSAIDs may cause a range of negative side effects, including stomach pain, heartburn, bleeding stomach ulcer, and liver or kidney abnormality. A topical NSAID may relieve pain and other symptoms of osteoarthritis of the knee, while minimizing the side effects common to oral NSAIDs. The purpose of this study is to determine the safety and effectiveness of a topical NSAID when used alone or when combined with an oral NSAID in the treatment of osteoarthritis of the knee.

During this 12-week study, patients will visit the study clinic 5 times. At the screening visit, the patient's demographic information, medical and medication history will be recorded and a physical examination performed. After washout of all NSAIDs/other analgesic medication, the patient will return for the baseline visit. During the treatment phase of the study, the patient will apply a topical solution to his/her osteoarthritic knee and take an oral study tablet. The patient may randomly receive active treatment with topical diclofenac, oral diclofenac, both, or neither (placebo). Follow-up clinic visits are conducted at 4, 8 and 12 weeks. Routine laboratory analyses are done at baseline, 4 and 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Primary osteoarthritis of the knee, verified radiographically
* Moderate flare of pain in the knee after washout of stable therapy
* If female, non-pregnant
* Ability to swallow moderately-sized tablets

Exclusion Criteria:

* Secondary osteoarthritis of the knee
* Major knee surgery at any time, or minor knee surgery in previous year
* Severe uncontrolled heart, liver or kidney disease
* Ulcer or bleeding from the stomach
* Corticosteroid use
* Fibromyalgia
* Skin disorder of the knee
GPC3-targeted CAR-T Cell for Treating GPC3 Positive Advanced HCC

Patients with hepatocellular carcinoma (a type of primary liver cancers) are enrolls in this study. The cancer has progressed after standard treatment, or the patient cannot receive regular treatment.

Investigator made a gene called chimeric antigen receptor derived from an antibody that recognizes Glypican 3, a protein detected in in a large proportion of hepatocellular carcinoma. The gene will introduce into T cell from patient's blood to make them recognize and kill cancer cells.

The aim of this study is to evaluate the efficacy, tolerance and safety of chimeric antigen receptor-modified T (CAR-T) cell targeting Glypican 3 for advanced hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. GPC3 positive HCC, tumor size \>= 5 cm, cannot receive standard treatment, Expected survival time\>=3 months.
2. Routine blood test: white blood cell count（WBC)\>= 2.5×10\^9/L, hemoglobin (Hb)\>= 9.0 g/dL, blood platelet \>= 60×10\^9/L, Lymphocyte percentage\>=15%.
3. Blood biochemical parameters: ALB \>= 30 g/L, ALT \<= 5 times of the normal value, AST \<= 5 times of the normal value, serum lipase\<=1.5 times of the normal value, serum amylase\<=1.5 times of the normal value， total bilirubin \<= 2.5 times of the normal value.
4. Prothrombin time INR \< 1.7.
5. Ejection fraction (EF) \>= 55%, oxygen saturation (SO2) \> 90%.
6. No allergic reaction to contrast material.
7. Karnofsky score \>= 60%.
8. Child-puge score \<7.
9. Peripheral venous access.
10. Voluntarily signed informed consent.

Exclusion Criteria:

1. Pregnancy or lactation.
2. Systemic steroid treatment ( \>prednisone equivalent/kg/day).
3. Patients with previous history of cell immunotherapy or antibody therapy.
4. Patients received radiotherapy/chemotherapy in the past 4 weeks.
5. Patients are participating in other clinical trials.
6. Patients with uncontrolled symptoms including infection, heart failure, arrhythmia.
7. Patients with acute allergic reaction.
8. History of liver transplantation.
9. Patients with anticoagulant treatment.
10. Patients with hepatic encephalopathy.
11. Eligible for hepatectomy, liver transplantation or other standard treatment.
12. Unstable gastrointestinal and respiratory bleeding.
13. Active viral, fungal or bacterial infections.
14. Heart failure classification (NYHA): II-IV.
15. Patients are unable or unwilling to comply with the requirements of the study protocol.
16. Patients do not meet the criteria above.
Kinesio Taping on Chronic Nonspecific Low Back Pain

This study propose analyze the effects of Kinesio Taping® in chronic nonspecific low back pain. All the subjects will be submitted to an evaluation of the painful sensation, functional performance, trunk range of motion and neuromuscular performance at three different times.


Eligibility Criteria:
Inclusion Criteria:

* Female between 18 and 50 years of age with chronic nonspecific low back pain for more than three months.

Exclusion Criteria:

* Serious spinal pathologies (fractures, tumors, and inflammatory pathologies such as ankylosing spondylitis);
* Nerve root compromise (disc herniation and spondylolisthesis with neurological compromise, spinal stenosis, and others);
* Fibromyalgia
* Corticosteroid treatment in the previous two weeks;
* Antiinflammatory treatment in the previous 24 hours;
* Contraindications to the use of Kinesio Taping (allergy or intolerance);
* Score of two or less on Visual Analogue Scale of the first day;
* Pregnancy;
* Previous Kinesio Tape therapy on lumbar.