cyrilzakka/clinical-trials huggingface dataset:
Aprepitant for Chemotherapy Induced Nausea and Vomiting in Chinese Advanced Non-small Cell Lung Cancers

Aprepitant is an oral neurokinin-1(NK-1) antagonist which is widely used for the prevention of chemotherapy-induced nausea and vomiting(CINV), it is metabolized by CYP34A, however, up to now it was still unknown the CINV control rate of aprepitant in Chinese non-small cell lung cancer(NSCLC) patients, we hypothesis that CYP3A4 and NK-1 polymorphism would influence aprepitant plasma concentration, which may lead to the individual difference of CINV control rate.

Patients pathologic diagnosed of advanced non-small cell lung cancer, according to NCCN non-small cell lung cancer guide line(2014 V2),the patient should receive standard platinum based chemotherapy, are randomized divided into two groups, aprepitant group and placebo group. In aprepitant group, patients would receive aprepitant 125 mg at day1, then 80 mg at day2 and day3. In placebo group, patients would receive placebo from day1 to day3. In both group, dexamethasone and 5-HT inhibitor palonosetron were give at the same dose. During the treatment, any grade of nausea and vomiting should be recorded in order to evaluate the complete response rate of CINV, other side-effects should be recorded. In aprepitant group, plasma should be taken for the analyze of plasma concentration, gene polymorphism of CYP3A4 and NK-1 should be analyzed for all the patients who received aprepitant if possible.

Eligibility Criteria:
Inclusion Criteria:

* patients pathologic diagnosed of advanced non-small cell lung cancer
* according to NCCN non-small cell lung cancer guide line(2014 V2), patients are suitable for platinum based chemotherapy.

Exclusion Criteria:

* patients could not receive platinum based chemotherapy judged by clinical doctors
* pregnancy or breast-feeding women
* any serious disease which could not be controled
* urine protein≥++, or 24h urine protein\>1g
* less than 18 years old or more than 75 years old
The Efficacy of the Traditional Chinese Medicine Fangji Huangqi Pill Combined With Mobic on Active Knee Osteoarthritis

Knee osteoarthritis (KOA) is known as degenerative joint disease, which is the most common form of arthritis and the leading cause of disability, loss of function and pain worldwide. Effective therapy to manage RA is still lack at present. Fangji Huangqi pill (FHP) is a Chinese medicine which has been widely used in treating KOA in China for hundreds of years to relieve pain, reduce swelling and protect the affected joints from further degeneration. However, no certain evidence to show the effect of FHP for the management of active KOA.

A randomized, double-blind, placebo-controlled clinical trials (RCT) will be conducted to explore whether the FHP could relieve pain and protect joints. 200 participants suffering from KOA will be enrolled and treated with FHP or placebo for 1 month. The primary outcome measures are the Visual analogue scale (VAS), Western Ontario and McMaster university of orthopedic index (WOMAC), the Lequesne index, and MOS Sleep Scale would be measured from the baseline to 1 month. The second outcome measures would be the six minutes walking test, the Short Form 36-item Health Survey (SF- 36), the X-ray of both knees, and the adverse events from the baseline to 2 weeks, 4 weeks, and 12 weeks' follow-up. In addition, the VAS score, the WOMAC score, the Lequesne index, and AIS Sleep Scale from the baseline to 2 weeks and 12 weeks' follow-up are also the second outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for knee osteoarthritis (American College of Rheumatology criteria)
* Grade 0-3 on the Kellgren-Lawrence grading system
* No serious medical history
* No known drug allergies
* No steroids, glucosamine, chondroitin sulfate, sodium hyaluronate before Fangji Huangqi pill treatment within 1 month

Exclusion Criteria:

* Combined with other disease such as rheumatoid arthritis, lupus arthritis and et. al
* Grade 4 on the Kellgren-Lawrence grading system
* Allergy to study drug
* Participating in other clinical trial
* Unwilling to give informed consent
Assessment of Safety and Efficacy of ThisCART19A in Adult Patients With B Cell Malignancies After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) Therapy

This is a a phase 1, open label study to assess the safety and efficacy of ThisCART19 (Allogeneic CAR-T targeting CD19) in adult patients with B cell malignancies after failure of autologous chimeric antigen receptor T- cell(CAR-T) therapy in china.

This is a phase 1, single-center, nonrandomized, open-label, dose-escalation and dose expansion study to evaluate the safety and efficacy of ThisCART19A in adult patients with B cell malignancies after failure of autologous chimeric antigen receptor T- cell(CAR-T) therapy and identify a treatment regimen most likely to result in clinical efficacy while maintaining a favorable safety profile.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with relapsed or refractory acute lymphocytic leukemia, or lymphoma；
2. No gender limitation, Age 14 years to 75 years (both upper and lower limits included)；
3. Failing to autologous CAR-T therapy；
4. Should be confirmed Cluster of differentiation(CD)19 positive；
5. The expected survival time is ≥12 weeks;
6. ECOG score 0-1;
7. Measurable or detectble disease at time of enrollment.
8. Adequate bone marrow, renal, hepatic, pulmonary and cardiac function；

Exclusion Criteria:

1. Allergic to preconditioning measures；
2. Patients with other malignancies other than B-cell malignancies within 5 years prior to screening. Patients with cured skin squamous carcinoma, basal carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical/breast cancer can be recruited；
3. Uncontrollable bacterial, fungal and viral infection during screening；
4. Patients had pulmonary embolism (PE) and/or deep vein thrombosis (DVT) within 3 months prior to enrollment;
5. Had intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases prior to enrollment；
6. The presence of central nervous system involvement；
7. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) or Human immunodeficiency virus (HIV) or Syphilis infection. HBV-DNA \< 2000 IU/mL can be enrolled, but should admitted to use anti-virus drugs such as entecavir, tenofovir, etc, and supervisory the relative indication during the treatment；
8. Had big lesion(single lesion diameter ≥10 cm)；
9. Receive allogeneic hematopoietic stem cell transplantation less than 100 days；
10. Vaccinated with influenza vaccine within 2 weeks prior to cleansing (SARS-COV19 can be included, inactivated, live/non-live adjuvant vaccinations allowed to be included)；
11. Patients who are receiving GvHD treatment; Patients without GvHD and who had stopped immunosuppressive drugs for at least 1 month were eligible for inclusion；
12. Women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after cell infusion. Male subjects who plan pregnancy within 1 year after infusion.
Gene-Environment-Interaction: Influence of the COMT Genotype on the Effects of Different Cannabinoids

The study evaluates the gene-environment interaction of the COMT-genotype on the effects of the phytocannabinoids delta-9-tetrahydrocannabinol, cannabidiol or a combination of both on induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal processing, and neural oscillations. In addition the effects of the phytocannabinoids on lipid levels in serum and cerebrospinal fluid, cognition, neural synchrony and neuronal processing assessed by EEG and fMRI.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent given by the subject
* Healthy young man (age between 18 and 45) insightful to the study (WST\> 95)
* Right handedness
* At least one time consumption of Cannabis but less than 10 times/ per lifetime, no consumption of other psychotropic agents (despite coffee or nicotine), no alcohol abuse
* Negative drug-screening at the time of screening
* Body Mass Index between 18 and 30

Exclusion Criteria:

* Lack of accountability
* Participation in other interventional trials
* Severe medical or neurological illness, especially cardiovascular, renal, advanced respiratory, hematological or endocrinological failures or infectious diseases (acute hepatitis A, B or C or HIV) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, at the discretion of the investigator
* Any known psychiatric illness in the participant's history
* Known family history concerning psychiatric disorders
* Cannabis consumption within the last six months
* Consumption of any illegal drugs (except cannabis in history, see above)
* Intake of interfering medication, at the discretion of the investigator
* High intracranial pressure
* Any disorders in stereoscopic vision (measured by the TNO-Test, Lamerics, Utrecht) or hearing deficits
* Contraindications due to the Investigators Brochure Contraindication for Magnetic Resonance Imaging (e.g. cardiac pacemaker, claustrophobia, attached brace, in body metal, tattoos) or lumbar puncture (e.g. local or systemic infection, disturbance of blood coagulation, medication with anticoagulants like Phenprocoumon)
ANTEAB: a Study of Early Antibiotherapy in the ICU Management of Acute Exacerbations of COPD

Intensive Care Unit (ICU) admission for acute exacerbation of chronic obstructive lung disease (COLD) is a major cause of morbidity and mortality in such patients. Although bacterial of mortality in such patients. Although bacterial and or viral infections are considered as the major precipitating factor, the antibiotic strategy in this setting is unclear. The absence of overt infection remains controversial, and has not been adequately studied in patients admitted to the ICU. To assess the benefit ( or lack thereof ) of routine early systemic antibiotic therapy in patients with COLD admitted to the ICU.

The primary objective of the essay is to evaluate the effectiveness of the precocious antibiotic therapy on the length of the respiratory symptoms with the admitted patients in polyvalent medical intensive care of chronic obstructive lung disease ( COLD )

This is a multicenter, randomised, double-blind controlled trial, comparing amoxicillin-clavulanic acid administered for 7 days to a placebo.

Eligibility Criteria:
Inclusion Criteria:

* Patients included are those with documented or suspected COLD, exclusive of other bronchial or lung disease, and admitted for acute exacerbation, in the absence of overt sepsis or broncho-pneumonia, and having no other organ.

Exclusion Criteria:

* Patients recently hospitalised, having received antibiotics since more than 24h, or on long-term steroids will not be included
Prophylactic Cholecystectomy is Not Mandatory in Patients Candidate to the Resection for Small Intestine Neuroendocrine Neoplasms: a Propensity Score-matched and Cost-minimization Analysis

To evaluate two competitive strategies in patients undergoing resection of Small-intestine Neuroendocrine neoplasms (Si-NEN): Prophylactic Cholecystectomy (PC) versus On-demand delayed cholecystectomy

This is a retrospective study based on 230 Si-NENs candidates to the primary tumor resection. Patients were divided into two arms: PC and OC. Propensity score matching was performed, reporting the d value. The primary outcome was the re-hospitalization rate for any cause. The secondary endpoints were the re-hospitalization rate for biliary stone disease (BSD), the mean number of re-hospitalization (any cause and BSD), the complication rate (all and severe), and the total costs. A P-value \< 0.05 was considered significant, and NNT\< 10 was considered clinically relevant.

Eligibility Criteria:
Inclusion Criteria:

* patients with a diagnosis of Si-NEN;
* resection of the primary tumor with or without concomitant cholecystectomy;
* absence of a history of a biliary stone disease or cholecystectomy before Si-NEN diagnosis

Exclusion Criteria:

- presence of a history of a biliary stone disease or cholecystectomy before Si-NEN diagnosis
Cardiorespiratory Changes in Patients Being Weaned Off Mechanical Ventilation

The objective of this study was to analyze changes in cardiac function using Doppler echocardiogram in critical patients during weaning from mechanical ventilation using two different weaning methods (pressure support and T-tube) and to compare a subgroup of patients: success vs. failure in weaning and patients with vs. without heart disease.

Weaning from mechanical ventilation (MV) involves physiological changes that can overload the cardiorespiratory system due to changes in the interaction between patient and ventilator.

This was a randomized crossover clinical trial that included patients in an intensive care unit (ICU) who had been on MV for more than 48 hours and who were considered ready for weaning. Cardiorespiratory variables, oxygenation, electrocardiogram (ECG) and Doppler echocardiogram findings were analyzed at baseline and after 30 minutes in each trial weaning method (PSV and T-tube). Comparisons were made between PSV and T-tube, weaning success and failure and patients with and without heart disease, using ANOVA and Student's t test. The level of significance was set at p \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* patients hemodynamically stable
* conscious (Glasgow scale ≥ 13)
* with adequate gaseous exchange (O2 saturation ≥ 95%, fraction of inspired oxygen (FiO2) ≤ 40% and positive end-expiratory pressure (PEEP) = 5
* with no acidosis or alkalosis)
* normal electrolyte levels
* presence of respiratory drive
* informed consent was signed by the patients and/or family members

Exclusion Criteria:

* hemodynamic instability
* severe intracranial disease
* barotrauma
Purpose in Life, Goals, and Expectations

Study investigators are inviting participants to participate in a study to describe older adults' and family caregivers' purpose in life, goals, and expectations for recovery after hospitalization. Study investigators will ask older adults and caregivers to take part in a telephone or online interview to ask questions and answer questionnaires related to their experience with the hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Older adults 60y+ and family caregivers
* after hospitalization

Exclusion Criteria:

* We will exclude older adults with a dementia diagnosis, head injury, significant neurological impairment, not expected to live for 6 months or longer, or who receive treatment for medical conditions precluding enrolment.
Pilot Study Evaluating Broccoli Sprouts in Advanced Pancreatic Cancer [POUDER Trial]

The goal of the POUDER trial is to determine the feasibility of a randomized controlled trial regarding the application of freeze-dried broccoli sprouts rich in sulforaphane and quercetin in patients with advanced pancreatic ductal adenocarcinoma that receive palliative chemotherapy.

Patients will be randomly classified into two groups - verum and placebo. The patients in the experimental arm will receive capsules with broccoli sprout grain containing a total of 90mg sulforaphane active substance per day over one year as nutrition supplement whereas patients assigned to the placebo group will receive inactive substance (methylcellulose) with identical capsule and portion distribution.

Eligibility Criteria:
Inclusion Criteria:

* Advanced, surgically non-treatable pancreatic ductal adenocarcinoma (surgical exploration, intraoperative biopsy but also palliative bypass interventions (bileodigestive anastomosis and/or gastroenterostomy because of preoperative cholestasis or impaired gastric emptying due to tumor-mass effect)
* Intact gastric emptying
* Written informed consent
* Patients ≥18 years of age
* Palliative chemotherapy

Exclusion Criteria:

* Intolerance to broccoli or its ingredients
* Impaired mental status or language problems / barriers
Open Label Trial of Deceased Donor Livers Transplanted After DHOPE With eXVIVO LIVER Perfusion

The purpose of this clinical study is to confirm the safety and effectiveness of dual hypothermic oxygenated perfusion (DHOPE) using the Liver Assist to preserve deceased donor livers for transplantation.


Eligibility Criteria:
Participant Inclusion Criteria:

1. Participant is able to provide informed consent and HIPAA authorization
2. Age ≥18 years
3. Participant is registered as an active first-time liver transplant candidate on the United Network for Organ Sharing (UNOS) waiting list for primary liver transplantation

   - For participants with hepatocellular carcinoma (HCC) as indication for Orthotopic Liver Transplantation, the tumor must be within Milan Criteria or down-staged to Milan Criteria at the time of transplant
4. Participant is willing to comply with the study requirements and procedures

Participant Exclusion Criteria:

1. Participant will undergo concurrent multi-organ transplantations (liver-kidney, liver-lung, etc.)
2. Participant is listed for liver transplantation due to fulminant liver failure (UNOS status 1A)
3. Participant is listed for a repeat liver transplantation (\>1 graft)
4. Participant is pregnant
5. Participant is on respiratory (ventilator dependent) and/or cardiocirculatory support (defined as mechanical circulatory support which requires at least one intravenous inotrope to maintain hemodynamics)
6. Participant is enrolled in an interventional clinical trial with an investigational drug or device
7. Presence of other medical, social, or psychological conditions that in the investigator's opinion, could limit the participant's ability to participate in the clinical trial
Nasal Irrigation to Reduce COVID-19 Morbidity

The purpose of this study is to evaluate if using nasal irrigation, also known as nasal lavage, for 14 days after a positive test in high risk patients can reduce the severity of symptoms associated with COVID-19. Nasal lavage consists of running salt water in one nostril and out the other to get rid of germs. Nasal irrigation was done with either Betadine or baking soda to determine if adding an antimicrobial or changing the pH of the mucous helped. Hospitalization and death were compared for combined nasal irrigation groups to the CDC dataset of patients aged 50+

The purpose of this study is to evaluate if using nasal irrigation, also known as nasal lavage, can reduce the severity of symptoms associated with COVID-19. Nasal lavage consists of running salt water in one nostril and out the other to get rid of germs. Saline nasal irrigation with Betadine or baking soda will be evaluated.

Participants will be asked to do several things during this study: watch a one minute video on YouTube, use a nasal irrigation device twice a day for 14 days, complete a one-time detailed survey and keep a research diary about their usage and symptoms using an on-line application called Qualtrics, agree to be texted reminders, be called on the phone if they fail to complete the daily diary two days in a row, agree to be called four times, and provide contact information for a secondary person who can be contacted if the primary participant is unavailable.

Participation in this study does not involve any significant risks. However, some people may find using nasal irrigation causes them some discomfort.

While there are no known benefits to participating in the study participants may see a reduction in their symptoms more quickly than if they didn't participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* Capable of understanding and providing informed consent using remote consent
* Willingness and physical capacity to initiate nasal irrigation and to adhere to the protocol
* Willing to give additional contact phone number of another person who will know the health status of the participant and agree to be contacted if needed for follow-up
* 55 years of age or older
* Has access to and the willingness and ability to adhere to the technological requirement of the study i.e. able to use a smartphone for voice and text and email and access to the internet at home
* English speaking
* Positive rapid COVID-19 test performed the day of or the day before enrollment

Exclusion Criteria:

* Currently doing daily nasal irrigation
* Current supplemental oxygen therapy
* Unwillingness to try nasal irrigation or use nasal irrigation twice a day
* Nasal surgery within the past year or chronic sinusitis
* Prior COVID-19 infection or positive test \>1 day before present
* Symptoms longer than 7 days prior to testing as reported to researchers
* Allergy to iodine or shellfish
* Participation in another prospective COVID related research project (clinical trial).
* Employed and working as a healthcare worker.
Evaluation of the Incidence of Palatal Fistula in Furlow Double-opposing Z-plasty vs. Two-flap Palatoplasty for Cleft Palate Repair

Evaluation of the incidence of palatal fistula in Furlow double-opposing z-plasty versus two-flap palatoplasty for cleft palate repair.

Up to 6 hours before the scheduled arrival time, formula-fed babies may be given formula. Up to 4 hours before the scheduled arrival time, breastfed babies may nurse. Up to 2 hours before the scheduled arrival time, give only clear liquids. Clear liquids include water, Pedialyte®, Kool-Aid® and juices you can see through, such as apple or white grape juice. In the 2 hours before the scheduled arrival time, give nothing to eat or drink. Induction of general anaesthesia will be administered followed by local anaethesia. Then, Surgical prodecure will be done either following the conventional two flap palatoplasty technique or the Furlow double-opposing z-plasty technique.

Eligibility Criteria:
Inclusion Criteria:

1. Age of Repair from 9 to 12 months.
2. Isolated Cleft Palate
3. Operation time should nearly be the same for all patients
4. Surgical skills done by same surgeon
5. Both sexes

Exclusion Criteria:

1. Patients with hypoplasia of palatal tissue.
2. Patients with associated anomalies.
3. Patients with associated syndromes.
4. Other types of cleft palate.
Eighteen-month Orthodontic Bracket Survival Rate With the Conventional Bonding Technique Versus RMGIC and V-prep

The aim of this study was to evaluate over eighteen months the clinical bonding failure and survival rates of the conventional bonding technique using the Transbond XT (3M Unitek, Monrovia, California, USA) and the RMGIC Fuji Ortho LC (GC Corporation, Tokyo, Japan) prepared with the V-prep. Therefore, one operator using the straight-wire technique bonded two hundred metallic brackets to upper and lower premolars of twenty-five patients requiring an orthodontic treatment. The randomized trial was a single-blind design in a split-mouth comparison. Each patient was randomly allocated one of the two bonding systems for each premolar on each side of the mouth. The bonding and rebonding techniques were standardized throughout the trial and bond failure was recorded each month for a period of eighteen months.


Eligibility Criteria:
Inclusion Criteria:

* require full orthodontic treatment of both arches
* mild or average overbite and crowding
* no restorations on the buccal surface of the premolars

Exclusion Criteria:

* Patients with required extractions in the treatment plan or with poor oral hygiene