cyrilzakka/clinical-trials huggingface dataset:
CT-P13 (Infliximab) Subcutaneous Administration by Pre-filled Syringe and Auto-injector in Healthy Subjects

This study compares two administration methods of CT-P13. Half of participants will receive CT-P13 by pre-filled syringe while the other half will receive CT-P13 by auto-injector.

This is a Phase I Study to Compare Pharmacokinetics and Safety between CT-P13 SC Pre-filled Syringe and CT-P13 SC Auto-injector in Healthy Subjects. A total of 218 healthy subjects will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subject
* Subject voluntarily agrees to participate in this study

Exclusion Criteria:

* Subject with medical history and/or condition
* Female who is pregnant or breastfeeding, or childbearing potential.
Optimize First-line Treatment for AL Amyloidosis With t (11; 14)

Achievement of complete hematologic response (CHR) is vital for systemic AL amyloidosis. Currently, the CHR rate of daratumumab, bortezomib, and dexamethasone (DBD) is close to 60%. Considering that Bcl-2 inhibitor is effective for AL amyloidosis with t(11; 14) and the median hematologic onset time of DBD is 7 days. We design a a prospective study on AL amyloidosis with t(11; 14). All patients receive DBD at the beginning. Patient will receive DBD for at least 6 cycles if achieve rapid hematologic response at day 7, while other patients will receive daratumumab, venetoclax and dexamethasone.

The goal of this clinical trial is to optimize the first line treatment for systemic AL amyloidosis with t(11;14). The aim of this study is to pursue early complete hematologic response. The primary endpoint is overall complete hematologic response (CHR) rate at 6 months. Participants will be treated according to the hematologic response after 7 days. If the patient get rapid response after 7 days, he/she will receive daratumumab, venetoclax and dexamethasone (DBD) for at least 6 cycles. If the patient do not get rapid response, he/she will receive daratumumab, venetoclax and dexamethasone.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of systemic AL amyloidosis;
2. Daratumumab, bortezomib, dexamethasone used in 1st line treatment;
3. Life expectancy greater than 12 weeks;
4. HGB ≥70g/L;
5. Blood oxygen saturation \>90%;
6. Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;
7. Informed consent explained to, understood by and signed by the patient.

Exclusion Criteria:

1. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
2. Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
3. Severe or persistent infection that cannot be effectively controlled;
4. Presence of severe autoimmune diseases or immunodeficiency disease;
5. Patients with active hepatitis B or hepatitis C (\[HBVDNA+\] or \[HCVRNA+\]);
6. Patients with HIV infection or syphilis infection;
7. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
Epilepsy Prevalence and Intervention Study in Zhejiang Province, China

To carry out the epidemiological investigation on epilepsy in Zhejiang Province, China, and then establish early comprehensive intervention to help patients with epilepsy to improve seizure control and the quality of life.

To carry out the epidemiological investigation on epilepsy in Zhejiang Province, China, and then establish early comprehensive intervention（proper antiepileptic drugs and education intervention） to help patients with epilepsy to improve seizure control and the quality of life.

Eligibility Criteria:
Inclusion Criteria:

Newly diagnosed and untreated epilepsy; Aged 14 and above; Sign the informed consents.

Exclusion Criteria:

With intellectual development disorder; With serious heart and lung diseases.
Treatment of Locally Advanced VULvar CArcinoma in a Neoadjuvant Setting With Carboplatin and Paclitaxel Chemotherapy (VULCANize)

Vulvar cancer is a rare malignancy. Surgery is the treatment of choice, but frequently causes invalidating and chronic postoperative morbidity, especially in patients with high stage disease. Theoretically, downstaging with neoadjuvant chemotherapy could shrink the tumour, making surgical treatment less extensive thereby diminishing the chance for morbidity.

Vulvar cancer is a rare malignancy. Surgery is the treatment of choice, but frequently causes invalidating and chronic postoperative morbidity, especially in patients with high stage disease. Theoretically, downstaging with neoadjuvant chemotherapy could shrink the tumour, making surgical treatment less extensive, thereby diminishing the chance for morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Woman k 18 years
* Signed and written informed consent.
* Histologically confirmed squamous cell vulvar carcinoma
* World Health Organization performance status of 0-2
* Adequate hematological function
* Adequate hepatic function
* Adequate renal function
* Negative pregnancy test for woman of childbearing potential
* measurable disease by physical examination
* TNM stage T2, any N, MO

Exclusion Criteria:

* Vulvar cancer other than squamous cell carcinoma at biopsy
* Previous radiotherapy of the vulva, groins or pelvis
* Patients with metastasis limited to the pelvic lymph nodes, who can be primarily operated with curative intent
* Other diagnosis of malignancy or evidence of other malignancy for 5 years before screening for this study
HighCycle Study: Effect of High Altitude on Sleep Disordered Breathing in Women Related to Their Menstrual Cycle Phase

Prospective cohort study investigating the menstrual cycle phase (MCP) dependent sleep disordered breathing (SDB) in women travelling to 3600 m.


Eligibility Criteria:
Criteria: Inclusion Criteria:

* Healthy, non-smoking women, age 18-44 years, without any diseases and need of regular medication (including oral contraceptives).
* BMI \>18 kg/m2 and \<30 kg/m2
* Born, raised and currently living at altitudes \<1000 m
* Written informed consent
* Premenopausal, eumenorrheic cycle

Exclusion Criteria:

* Other types of contraceptives (hormonal intrauterine device, vaginal ring, subcutaneous injections or implants, among others)
* Pregnancy or nursing
* Anaemic (haemoglobin concentration \<10g/dl)
* Any altitude trip \<4 weks before the study
* Allergy to acetazolamide and other sulfonamides
Auricular Acupuncture as Part of Multimodal Analgesia After Lower Leg Fracture

The purpose is to find out if incorporation of an intraoperative electro auricular acupuncture protocol when added to a standard multimodal analgesic regimen for patients undergoing surgery to repair lower leg fracture under spinal anesthesia will help reduce postoperative opioid use.


Eligibility Criteria:
Inclusion Criteria:

1. Patient ages 18-64
2. American Society of Anesthesiology Physical Status I, II or III
3. Inpatients scheduled to undergo ankle ORIF at Harris Health System Ben Taub Hospital

Exclusion Criteria:

1. Renal dysfunction (Serum Cr \> 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications
2. Allergy to any of the standard anesthetic agents
3. Patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder)
4. Patient or surgeon refusal
Treatment of Type I Hepatorenal Syndrome (HRS) With Pentoxyfylline

Pentoxyfylline therapy in addition to the standard of care of albumin, midodrine and octreotide therapy is superior to the standard of care alone in the treatment of Type I hepatorenal syndrome in the first 14 days of hospitalization.

Each hospitalized subject will undergo pre-dosing screening with review of his or her history and physical exam from the day of enrollment and safety assessment to ensure no contraindication to use of PTX. Type I HRS will be defined according to the criteria put forth by the American Association for the Study of Liver Disease as (1) cirrhosis with ascites; (2) serum creatinine greater than 1.5 mg/dL; (3) no improvement of serum creatinine (decrease to a level of 1.5 mg/dL or less) after at least two days with diuretic withdrawal and volume expansion with albumin; (4) absence of shock; (5) no current or recent treatment with nephrotoxic drugs; and (6) absence of parenchymal kidney disease as indicated by proteinuria \>500 mg/day, microhematuria (\>50 red blood cells per high power field), and/or abnormal renal ultrasonography. Baseline testing will be obtained from hospitalization records, including but not limited to chemistry panel, liver function testing, urinalysis, urine electrolytes, coagulation studies, blood cultures, chest x-ray, diagnostic paracentesis, abdominal ultrasound with Doppler.

Subjects will take either placebo three times a day or pentoxyfylline 400mg three times a day or 400mg twice a day for eGFR 10-50 and 400mg once a day for eGFR \<10 for 90 days in addition to standard AMO therapy. Treatment will be continued for 14 days unless a study endpoint has been reached at which time either PTX or placebo will be stopped

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with acute or chronic liver disease
* Type I HRS
* Aged greater than or equal to 18
* Non-pregnant

Exclusion Criteria:

* Allergy or hypersensitivity to PTX or intolerance to methylxanthines (e.g. caffeine, theophylline)
* Concurrent use of nephrotoxic drugs
* Age less than 18
* Pregnancy
* Uncontrolled bacterial infection
* Renal parenchymal disease (e.g. acute tubular necrosis, glomerular disease, interstitial nephritis and urinary obstruction)
* Shock
* TNF alpha antagonist use
* Subject is institutionalized or a prisoner
* Recent cerebral or retinal hemorrhage (contraindication to PTX)
* Severe or poorly controlled cardiovascular disease as determined by the principal investigator to hinder the ability to adhere to study protocols
Effect of Insulin Degludec Versus Insulin Glargine on Glycemic Variability in Patients With Type 2 Diabetes Mellitus

Type 2 diabetes mellitus (T2DM) is characterized by wide fluctuations of glucose. The long-acting insulin has showed to improve glycemic variability however the behavior of insulin glargine versus insulin degludec is unknown.

Cross-over, double dummy, randomized, clinical trial was carried out. The sample size was calculated using the formula for clinical trials of mean differences with an "n" of 6 patients per group was obtained. Patients between 30 and 65 years of age will be included with T2DM, without hyperglycemic drugs, hemoglobin A1c (A1C) 6.5 to 11.0 % and with written signature consent. They were assigned randomly by sealed envelope either to received insulin Degludec (Novo Nordisk A/S. Bagsvaerd, Denmark) or insulin Glargine (Sanofi-Aventis Deutschland GmbH. Frankfurt, Germany) \[10 international units (IU) subcutaneous (SC) every 24 hours for six days\], patients who were administered initially insulin Degludec corresponded then insulin Glargine and vice versa, with a washout period of 14 days between each intervention.

The clinical findings and laboratory tests included a metabolic profile and biosafety, which will be made at baseline. Body weight, body mass index and blood pressure were performed during the initial visit, likewise, interstitial glucose concentrations by ambulatory continuous glucose monitoring system (Guardian®, Medtronic MiniMed, Northridge), through which the mean amplitude of glucose excursions (MAGE) and area under the curve of glucose were calculated, which served to assess the glycemic variability. Adverse events and adherence to treatment are documented. Statistical analysis: Mann-Whitney U test, Chi2, Fisher exact test. It is considered with significance at p \<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Patients with T2DM without treatment for at least 3 months Body mass index (BMI) from 25.0-34.9 kg/m2 Diagnosis of T2DM
* Fasting plasma glucose ≤300 mg/dL at the time of scrutiny
* A1C between 6.5 and 11%
* Written informed consent

Exclusion Criteria:

* Women pregnant or breastfeeding
* Untreated thyroid disease and/or uncontrolled hypertension \[≥150 systolic and diastolic ≥90\]
* Consumption of oral agents or other medications or supplements with proven properties that modify the behavior of glucose. In the case of antihypertensives, these may be included if treatment was not modified previous 3 months and no change during the study.
* Total cholesterol \>240 mg/dL
* Triglycerides ≥400 mg/dL
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) more than twice the normal range
* Glomerular filtration rate \<60 mL/min \[Cockcroft-Gault\]
Bihar School Teachers Study

BRIEF SUMMARY: This study, which is closed to enrollment, is testing the efficacy of a tobacco-control intervention geared towards school teachers in Bihar, India. This cluster randomized trial aims to promote tobacco use cessation among teachers and increase tobacco policy adoption in 72 Bihar schools. Teachers are the focus of the study because as role models for youth and key opinion leaders related to community norms, they represent an important group for tobacco control. Teachers in Bihar also have reported high rates of tobacco use. According to the Global School Personnel Survey conducted in 2006, 39% of teachers in the eastern region of India (which includes Bihar) use some form of tobacco, compared to the national average of 29%. This study aims to reduce these numbers through discussion groups with teachers, individual cessation counseling, educational materials, and a tobacco policy workgroup in each intervention school. This study is a collaboration between US researchers and researchers at the Healis-Sekhsaria Institute for Public Health, Mumbai India.


Eligibility Criteria:
Inclusion Criteria:

* Government schools including grades 8-10 from within 10 school districts

Exclusion Criteria:

* Schools with fewer than 8 teachers
* Schools located in flood zones
Atorvastatin Before Prostatectomy and Prostate Cancer

This single-center, randomized, double-blind trial assesses the impact of short-term atorvastatin administration on proliferation activity, apoptotic rate and histological inflammation in prostate tissue.

In this trial 160 men who have been diagnosed with prostate cancer, and whose first-line treatment will be radical prostatectomy (surgical removal of the prostate), are randomized to receive either 80 mg atorvastatin or placebo daily for 2-5 weeks until the operation. Blood cholesterol and serum PSA are measured before starting the study drug use and before the operation.

After the operation change in PSA and histological inflammation, apoptotic rate and Ki-67 staining intensity are compared between atorvastatin-treated and placebo-treated men. The correlation between changes in serum cholesterol or prostate specific antigen (PSA) and the tissue characteristics is evaluated.

After recruiting 60 men we will perform an interim analysis on primary end-points without breaking the blinding to treatment allocation. If we observe a statistically significant difference in all primary end-points, the trial will be stopped early and the results published.

Additionally, atorvastatin concentration in the blood and the prostate tissue is measured with mass spectrometry to determine penetrance of atorvastatin into the prostate. DNA- and RNA-samples are obtained from the prostate tissue and the blood. These will be used to study how gene expression of statin- and cholesterol-modifying enzymes affects the responses observed in prostate tissue.

As a secondary end-point we will measure recovery of erectile function after the operation and compare between the two study arms. Erectile function is measured using IIEF-5 questionnaire once before the operation and again 3, 6, 9 and 12 months from the prostatectomy.

Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer proven histologically in prostate biopsy
* Radical prostatectomy selected as the first-line treatment
* Willingness to participate and sign informed consent

Exclusion Criteria:

* Previous oncological treatments for any malignancy
* Previous usage of statins, finasteride or dutasteride within a year prior to prostate cancer diagnosis
* Clinically significant liver- or kidney insufficiency (plasma alanine aminotransferase level is twice over the recommended upper limit or serum creatinine level is over 170 µmol/l)
* Previous adverse effects from cholesterol-lowering treatment
* Ongoing use of drugs having interactions with statins (St John's Wort, HIV protease inhibitors, ciclosporin, macrolide antibiotics, fusidic acid, phenytoin, carbamazepine, dronedarone or oral antifungal medication)
Relationship Between Optimal Laryngeal Mask Airway Cuff Volume and Physical Examination of Head and Neck

Overinflation of laryngeal mask airway cuff increase side effect like hoarseness, vocal cord paralysis, sorethroat. The investigators will study correlation between laryngeal mask airway cuff volume and pressure and physical examination of head and neck.

Overinflation of laryngeal mask airway cuff can induce side effects like hoarseness, vocal cord paralysis, sorethroat. Some study revealed that 60cmH2O of intracuff pressure is maximum pressure which is not increase side effect.

The manufacturer recommends that the cuff is inflated with the minimum volume of air required to provide an effective seal(max volume - size 3, 20 ml; size 4, 30 ml; size 5, 40).

The investigators will measure anatomical structure (neck circumference, neck length, thyroid-mental distance, etc.) which can influence cuff volume and pressure and find correlation between cuff volume and physical figure measured.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age 19-65)
* American Society of Anesthesiology Classification I-III

Exclusion Criteria:

* cardiovascular disease, cerebrovascular disease, pulmonary disease
* patient who have operation history for airway
* patient who expected difficult intubation
* patient who have risk of aspiration
Effect of Perineal Cryotherapy on Episiotomy

The present study aims to evaluate the effect of perineal cryotherapy on episiotomy- associated pain among postpartum women.

The study hypothesis: Post-partum women who apply perineal cryotherapy have lower level of episiotomy- associated pain than those who don't apply.

The present study included postpartum mothers who are in a good health immediately after giving delivery, having an episiotomy and a normal vaginal birth of a single, full term, healthy baby with normal weight and vertex presentation.

Eligibility Criteria:
Inclusion Criteria:

* Postpartum mothers who are in a good health immediately after giving delivery.
* Having an episiotomy and a normal vaginal birth.
* Having a vaginal birth at full term.
* The delivery of a healthy single fetus having normal weight and vertex presentation.

Exclusion Criteria:

* Women who are experiencing labor or complications after giving birth, such as hemorrhage, a tear, or a cut in the perineum.
Chest Drain Regular Flushing in Complicated Parapneumonic Effusions and Empyemas

Infections of the pleural space are common, and patients require antibiotics and chest drain placement to evacuate the chest from the infected fluid. Chest drains can get blocked by the drainage fluid and material. For this reason, it is thought that flushing the chest drain with saline solution, can help maintain the patency of the tube. This proposed study will evaluate the impact of regular chest drain flushing on the length of time to chest tube removal and total hospitalization as well as improvement in chest imaging and the need for additional interventions on the infected space.

There are no randomized controlled trials (RCTs) evaluating the role of regular chest tube flushing in the setting of pleural space infection for optimal drainage and treatment outcomes. Most studies of \<16 Fr catheters have used both flushing and suction to decrease the likelihood of catheter blockage and improve drainage efficiency, however, this practice has never been studied prospectively or in RCTs. Regular flushing (e.g., 20-30 ml saline every 6 h via a three-way tap) is recommended for small chest drains by the British Thoracic Society (BTS) 2010 Guidelines. This practice is followed variably by some and not used by others. Importantly, the role of this practice in successful drainage of infected fluid, and patient-centric outcomes has not been investigated. Inconsistent flushing practices confound the interpretation of therapeutic modalities (such as intrapleural tissue plasminogen activator and deoxyribonuclease therapy) success or lack thereof and limit the execution of RCTs and prospective studies of the pleural space in the setting of infection.

Eligibility Criteria:
Inclusion Criteria:

* Patients with complicated parapneumonic pleural effusion and empyema requiring chest tube placement as standard of care for inpatient management of their pleural space infection with or without intrapleural tissue plasminogen activator and deoxyribonuclease therapy
* Age \> 18 years old.

Exclusion Criteria:

* Patients who have surgical tubes that can't accommodate a three-way stopcock.
* Study subject has any disease or condition that interferes with the safe completion of the study.
* Inability to provide informed consent.
* Inability to undergo a chest X-ray.
* If the managing clinician believes the chest tube will be placed for less than 24 hours.
* Patients with an indwelling pleural catheter (IPC)
Effects of Garlic Supplements on Drug Metabolism

This study will determine whether garlic supplements affect the way certain drugs are processed in the body.

Garlic supplements, which are often used to lower cholesterol and prevent cancer, are one of the most commonly used herbal products in the United States.

However, little is known about the way garlic supplements may interact with prescription medications when used simultaneously. This study will investigate four commonly used garlic supplements: garlic powder with a low content of allicin (a compound with antibacterial properties), garlic powder with a high allicin content, garlic oil, and aged garlic. The effects of these 4 garlic products on the drug-metabolizing enzyme cytochrome P450 (CYP) and a drug transporter, P-glycoprotein (Pgp) will be examined.

Participants will be randomly assigned to receive one of the four garlic supplements for 4 weeks. Drug probes of CYP and Pgp will be used to assess the in vivo activities of the substances. On the first day of garlic ingestion, blood collection will occur immediately after participants ingest their garlic supplement and 3, 4, and 6 hours after ingestion. Urine collection will occur immediately after participants' first garlic ingestion and 12, 15, and 72 hours after ingestion. Blood and urine collection will determine the concentration of the drug probes in the body, which will indicate changes in CYP and Pgp. Blood and urine tests will be repeated at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 20 and 32
* Able to read and understand English
* MUST LIVE WITHIN THE SEATTLE, WA AREA.

Exclusion Criteria:

* Current use of herbal medicines other than oral contraceptives
* History of cardiopulmonary, liver, renal or endocrine disease
* Allergy or sensitivity to any of the drugs that will be used in the probe cocktails or the garlic supplements
* Daily consumption of vegetables with a high allium content, including garlic, shallots, leeks, and chives
* Pregnancy or breastfeeding