cyrilzakka/clinical-trials huggingface dataset:
Timing of Damage Control Orthopedic Surgery

The decision to operate and surgical timing on multi-trauma patients remains controversial, inappropriate surgical timing may cause more complications which lead to poor prognosis. We hope to find out the connection between lactate and prognosis in multi-trauma patients, and the optimal timing of definitive treatment.

The decision to operate and surgical timing on multi-trauma patients remains controversial, inappropriate surgical timing may cause more complications which lead to poor prognosis.

The aim of our study is to analyze if serum lactate a predictive factor of optimal surgical timing in multi-trauma patients. In order to obtain more accurate data, we choose to utilize ili database and trauma database instead of National Health Insurance Research Database.

Multi-trauma patients from 2002 through 2022 were included to our study. We hope to find out the connection between lactate and prognosis in multi-trauma patients, and the optimal timing of definitive treatment.

Eligibility Criteria:
Inclusion Criteria:

* (1) Injury severity score(ISS) \> 16 with pelvicfracture or long bone fracture requiring surgical fixation (2) Patient age ≥ 20. Pathologic fracture was excluded. Our primary endpoint si mortality rate, secondary endpoints include ICU stay, ICU complications (Sepsis, Pneumonia, Multiple organ failure)

Exclusion Criteria:

* death before into undergoing surgery
The Children's WEAR Trial(Phase 1&2)

Phase I: Focus groups on different designs of adjustable glasses and standard glasses (August-September 2012) Phase II: Two-month randomized trial comparing four groups: (September 2012 - August 2013)

Phase I: Focus groups on different designs of adjustable glasses and standard glasses (August-September 2012) Phase II: Two-month randomized trial comparing four groups: self-refraction with adjustable glasses, receiving custom standard glasses; subjective refraction by an expert refractionist after cycloplegic automated refraction and receiving custom standard glasses; subjective refraction by a rural refractionist after cycloplegic automated refraction, receiving custom standard glasses; and subjective refraction by an expert refractionist after cycloplegic automated refraction receiving ready made glasses (September 2012 - August 2013)

Eligibility Criteria:
Inclusion Criteria:

phase1: - aged 12-17 years

* with \<= -1.00D of myopic refractive error in each eye phase2: - 12-15 years old children from two locations in Guangdong Province
* with uncorrected vision \</= 6/12 in at least one eye thought to be due to refractive error (that is, correctable to at least 6/7.5 with cycloplegic subjective refraction by an optometrist)

Exclusion Criteria:

* those corrected VA can not up to 6/7.5 with cycloplegic subjective refraction by an optometrist
* those with significant strabismus or vision abnormality (keratopathy, cataract, vitreous macular diseases ), or with vision deficiency ( amblyopia ) children are to be excluded.
* Children developing acquired vision problems other than myopia
Probiotic and Antibiotic Therapies in Women With Unexplained Infertility

The study is designed as a proof of concept pilot study with 3 study arms to evaluate the safety and feasibility of the use of oral probiotics and/or antibiotics in women with unexplained infertility/endometriosis. Our secondary outcomes will assess In Vitro Fertilization outcomes, and changes in the uterine microbiota (bacteria), intestinal barrier integrity, and urinary metabolites in response to study interventions.

Previous research has demonstrated that the uterine microbiota can impact fertility and embryo implantation. This information leads to the hypothesis that prophylactic antibiotic and/or probiotic treatment may improve reproductive outcomes in women with unexplained infertility/endometriosis who are seeking In Vitro Fertilization (IVF). No therapeutic protocols to improve these outcomes currently exist. However, there are safe and easily accessible medications and supplements that may be able to optimally modify the uterine microbiota. Herein we are proposing a proof of concept pilot study of the feasibility, safety and tolerability of administering oral probiotics, or oral probiotics in combination with antibiotics, to women seeking IVF.

Eligibility Criteria:
Inclusion Criteria:

1. Female aged 18-40 at the time of egg retrieval
2. Generally in good health (at physician's discretion)
3. Diagnosed with Unexplained Infertility
4. Diagnosed with or suspected of having endometriosis (at ONE Fertility physician's discretion)
5. Normal uterine cavity as assessed by prior sonohysterogram
6. Planning to undergo Frozen Embryo Transfer with ≥1 frozen blastocyst ≥3BB (grade Gardner) to transfer
7. Able to understand, comply and consent to protocol requirements and instructions
8. Able to attend scheduled study visits and complete required investigations

Exclusion Criteria:

1. Any known endometrial pathologies other than endometriosis
2. Polycystic ovary syndrome
3. Ovulatory dysfunction
4. Male factor infertility (Total Motile Sperm Count \<5M/mL)
5. Poorly controlled auto-immune disease and/or diabetes (at physician's discretion)
6. Is immune-compromised
7. Cockayne syndrome
8. Allergy to Metronidazole
9. Allergy to rice (bran and hull), pomegranate, Acacia gum, hypromellose, fermented gellan gum, chlorophyllin, or sunflower oil
10. Known intolerance of Lactobacillus and/or Bifidobacterium-containing probiotics
11. Antibiotic use in the past month
12. Use of any of the following:

    1. Oral probiotics
    2. Alcohol
    3. Anticoagulant therapies (Warfarin type)
    4. Drugs containing alcohol
    5. Busulfan
    6. Cyclosporin
    7. Disulfiram
    8. 5-Fluoruracil
    9. Lithium
    10. Phenytoin or Phenobarbital
    11. Vecuronium
    12. Proton pump inhibitors
    13. Histamine H2-receptor antagonists
13. Currently experiencing nausea, fever, vomiting, bloody diarrhea or severe abdominal pain
Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP

The project was undertaking by Qilu Hospital of Shandong University and other 18 well-known hospitals in China. In order to report the efficacy and safety of decitabine combining with dexamethasone for the treatment of adults with immune thrombocytopenia (ITP), compared to dexamethasone alone .

The investigators anticipate to undertaking a parallel group, multicentre, randomised controlled trial of 200 ITP adult patients from 19 medical centers in China. One part of the participants are randomly selected to receive dexamethasone (given 40mg/d for 4 consecutive days as a cycle , If platelet count remained below 30 × 109/L or there were bleeding symptoms by day 10, an additional cycle of dexamethasone was given) combining with decitabine (given intravenously at a dose of 3.5mg/m2/d for 4 consecutive days as a cycle and repeated every 2 weeks for 3 cycles), the others are selected to receive dexamethasone therapy(given 40mg/d for 4 consecutive days as a cycle, If platelet count remained below 30 × 109/L or there were bleeding symptoms by day 10, an additional cycle of dexamethasone was given). Platelet count, bleeding and other symptoms were evaluated before and after treatment, adverse events are also recorded throughout the study in order to report the efficacy and safety of the combination therapy compared to dexemathasone alone therapy for the treatment of adults with ITP.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria for immune thrombocytopenia.
2. within 3 months fromdiagnosis,untreated patients, may be male or female, between the ages of 18 \~ 80 years.
3. To show a platelet count \< 30×10\^9/L, and with bleeding manifestations.
4. Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2.

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
2. Received high-dose steroids or intravenous immunoglobulin transfusion(IVIG) in the 3 weeks prior to the start of the study.
3. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
4. Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
5. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
6. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
7. Patients who are deemed unsuitable for the study by the investigator.
A Study to Evaluate the Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China

The purpose of this study is to evaluate the pharmacokinetics and safety of ASC16 after 3-single dose(50mg、100mg、200mg) or fixed continuous dose(200mg) in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-45 years old;
* Male body weight not less than 50kg; Female body weight not less than 45kg; BMI in the range of 19\~24kg/m2
* Healthy men or women based on history, physical examination, laboratory examination and ECG.
* no plan of pregnancy in at least six months, and willing to take effective measures to prevent contraception from the first time when the drug is administered till the last time the drug is administered within 30 days.
* Female has negative pregnancy tests at the screening stage.
* Voluntary to sign the informed consent.

Exclusion Criteria:

* Have medical history, or has disease, such as cardiovascular system, respiratory system, endocrine and metabolic system, urinary system, digestive system, blood system, nerve system disease or psychiatric disease and acute or chronic infectious diseases and malignant tumors.
* Has a history of drug or food allergy.
* Positive hepatitis A antibody，positive hepatitis B surface antigen， positive hepatitis C antibody，syphilis antibody or HIV antibody at screening.
* Laboratory tests out of normal range and judged by the investigators as clinically significant.
* Had gastrointestinal surgery, vagotomy, intestinal resection or any possible interference with gastrointestinal peristalsis, pH or absorbed by surgery.
* Pregnant, lactating women and people who unwilling to take effective measures to prevent contraception.
* People who consumed pomelo, apple or orange and foods or drinks containing their extracted ingredients within 3 days of taking the drug.
* Any prescription or over-the-counter medications, herbs, and vitamins are required to be taken prior to or within the first month of taking the drug.
* Selected within the first 6 months of smoking, alcohol, drug abuse or history of drug abuse.
* Selected within the first 3 months had blood loss or blood donation of 200ml.
* Participate in other clinical trials within the first 3 months of the study and received other study drug treatment.
* In addition to the above, the investigators judged not suitable for participating in this clinical trial.
Efficacy of Albuterol SPIROMAX® in Adult and Adolescent Patients With Exercise-Induced Bronchoconstriction (EIB)

The primary objective of this study is to evaluate the efficacy of a single dose (2 inhalations, 180 mcg total) of Albuterol SPIROMAX (90 mcg per inhalation) versus placebo in patients with EIB.

This study is a single-dose, randomized, double-blind, placebo-controlled, 2-treatment, 2-sequence, 2-way crossover, multicenter study in patients with a documented history of EIB, with or without underlying asthma. Each patient will participate in the study for approximately 5 weeks. Each patient will complete 2 screening visits (SV1 and SV2), 2 treatment visits (TV1 and TV2), and a follow-up telephone call (FV).

Eligibility Criteria:
Inclusion Criteria:

* Informed consent/assent: For patients 18 to 50 years of age, inclusive, written informed consent signed and dated by the patient before conducting any study related procedures and review of Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization; for patients 12 to 17 years of age, inclusive, written informed consent signed and dated by the parent/legal guardian and written assent signed and dated by the patient before conducting any study related procedure and review of HIPAA authorization.
* Male or female patients 12 to 50 years of age, inclusive, as of SV1.
* If female, is currently not pregnant, breastfeeding, or attempting to become pregnant, has a negative serum pregnancy test, and is of non-childbearing potential.
* Documented history of EIB, with or without underlying asthma. The underlying asthma must be well-controlled (in the investigator's judgment) as per the National Asthma Education and Prevention Program, Expert Panel Report (NAEPP, EPR-3).
* Other criteria apply.

Exclusion Criteria:

* Requires a rescue bronchodilator following the exercise challenge at SV1 for a decrease in FEV1 that does not return to within 20% of their pre-exercise challenge FEV1 within 30 minutes after administration of the rescue medication.
* Pregnant, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days after the patient's last study related visit (for eligible patients only-if applicable).
* Participation in any investigational drug trial within the 30 days preceding SV1 or planned participation in another investigational drug trial at any time during this trial.
* A known hypersensitivity to albuterol or any of the excipients in the formulation.
* History of severe milk protein allergy.
* History of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, otitis media, acute or chronic sinusitis, influenza, etc) that has not resolved within the 2 weeks preceding SV1.
* Other criteria apply.
Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study

The Mood Disorder Cohort Research Consortium (MDCRC) study is designed as a naturalistic observational prospective cohort study for early-onset mood disorders (major depressive disorders, bipolar disorders type 1 and 2) in South Korea.

The Mood Disorder Cohort Research Consortium (MDCRC) study is designed as a naturalistic observational prospective cohort study for early-onset mood disorders (major depressive disorders, bipolar disorders type 1 and 2) in South Korea. The study subjects consist of two populations: 1) patients with mood disorders under 25 years old and 2) patients with mood disorders within 2 years of treatment under 35 years old. After successful screening, the subjects are evaluated using baseline assessments and serial follow-up assessments at 3-month intervals. Between the follow-up assessments, subjects are dictated to check their own daily mood status before bedtime using the eMood chart application or a paper mood diary. In addition, wearable activity tracker(Fitbit charge series) is applied for data collection such as activity, sleep, and heart rate during every moments. At the regular visits every 3 months, inter-visit assessments are evaluated based on daily mood charts and interviews with patients. In addition to the daily mood chart, sleep quality, inter-visit major and minor mood episodes, stressful life events, and medical usage pattern with medical expenses are also assessed. Genomic DNA from blood is obtained for genomic analyses. From the MDCRC study, the clinical course, prognosis, and related factors of early-onset mood disorders can be clarified. The MDCRC is also able to facilitate translational research for mood disorders and provide a resource for the convergence study of mood disorders.

Eligibility Criteria:
Inclusion Criteria:

1. under 25 years old with mood disorder
2. under 35 years old with mood disorder within 2 years of treatment

Exclusion Criteria:

1. patients with intellectual disability
2. patients with organic brain injury
3. patients have difficulty reading and understanding the Korean language
A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion in Patients With Advanced Cancer.

This study was a randomized, single dose crossover comparison of the investigational product with a Reference Product (vinorelbine tartrate injection, NAVELBINE®). The primary objective was to demonstrate the equivalence of ANX-530 and the Reference Product, NAVELBINE.

ANX-530 (vinorelbine tartrate injectable emulsion), an investigational drug, is an oil-in-water emulsion of vinorelbine tartrate composed of an oil phase and emulsifier dispersed in an aqueous solution. ADVENTRX Pharmaceuticals, Inc. of San Diego, California, developed ANX-530 as a vinorelbine tartrate formulation to be used in clinical settings where Vinorelbine Tartrate Injection (NAVELBINE) is indicated. Nonclinical toxicology studies suggest either equivalent or less toxicity of ANX-530 compared to Reference Product. In particular, ANX-530 caused less vein toxicity in a rabbit vein irritation model, suggesting ANX-530 could potentially cause less venous irritation than NAVELBINE in a clinical setting. ADVENTRX is investigating whether ANX-530 could substitute for NAVELBINE in these settings.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Advanced cancer potentially sensitive to vinorelbine:
* Breast cancer.
* Stage 3 or 4 non-small cell lung cancer.
* Non-Hodgkins lymphoma.
* Cancer of other histologic type, sensitive to vinca alkaloids.
* Rare tumor type with no standard treatment, for which single agent vinorelbine is appropriate therapy.
* Failure of standard treatment(s) of the tumor.
* Life expectancy of at least three months.
* ECOG performance level 0-2 or Karnofsky score 100-70.
* Hematological and serum chemistry results with defined ranges.
* Willingness and ability to provide written informed consent.

Exclusion Criteria:

* Pregnancy or lactation. In a woman of childbearing potential, a positive pregnancy test result, no pregnancy test result, or no use of reliable contraception, at baseline. A postmenopausal woman will be considered to be of childbearing potential until there has been amenorrhea for at least 12 consecutive months.
* Previous treatment with vinorelbine or mitomycin.
* Any history suggesting or demonstrating resistance to, lack of response to, or intolerance of any prior vinca alkaloid treatment.
* Active infection.
* Prior anticancer therapy completed within four weeks prior to the first day of study treatment.
* Failure to have recovered from any toxicity of previous cancer treatment (patients with alopecia will not be excluded).
* Participation in another experimental drug study within four weeks prior to the first day of study treatment.
* Requirement for any concomitant chemotherapeutic agent other than the study medication.
* Any investigator judgment that the individual would not be an appropriate study subject.
Effect of Increasing Doses of Cystine Binding Thiol Drugs on Cystine Capacity in Patients With Cystinuria

The purpose of this study is to evaluate the effect of escalating doses of cystine biding thiol drugs, including tiopronin and d-penicillamine, on the urinary cystine capacity, which is a measure of the amount of cystine in the urine, in patients with cystinuria. The overall goal will be to help guide therapy and ultimately minimize unnecessary side effects caused by larger doses.

Cystinuria is a rare genetic cause of kidney stones that leads to significant morbidity due to the recurrent nature of the disease. As a result, a significant part of treatment is focused on prevention of stone formation. Current methods of prevention include increasing fluid intake, dietary modifications, alkali therapy, and cystine binding thiol drugs (CBTDs), which help increase the solubility of cystine in the urine. At present, the dosing of CBTDs is empiric, and not titrated to a specific measured effect. Our primary objective will be to measure the effect of increasing doses of CBTDs on cystine capacity. The investigators predict that higher dosages of these medications will lead to a more positive urinary cystine capacity, or the ability of urine to take up more cystine (and therefore decreased risk of stone formation). However, the dose at which increasing dosages of the medications cease to provide additional benefit is unknown. The investigators will directly measure the cystine capacity in the urine in response to increasing doses of medications to determine if there is a dose at which the maximum benefit of the drug exists.

This is a cross-over trial of escalating doses. There will be four parts to the study. In the first part, subjects will stop taking CBTDs for 7 days, and perform a 24-hour urine collection on day 7. In part 2, they will take their usual CBTD (either tiopronin or d-penicillamine) 1 gram per day for 7 days. They will perform another 24-hour urine collection on day 7 of this study period. In part 3, they will take their usual CBTD at 2 grams per day for 7 days and in part 4 they will take their CBTD at 3 grams per day for 7 days. Again, they will perform 24-hour urine collections on day 7 of each period. The order in which the parts of the study are performed will be randomized for each subject. The mean cystine capacities in each part of the study will be compared to determine the effect of drug dosage on urinary cystine capacity.

Eligibility Criteria:
Inclusion Criteria:

* Be a patient with a confirmed diagnosis of cystinuria.
* Be already taking a CBTD (either D-penicillamine (Cuprimine®) or tiopronin (Thiola®) as part of your medication regimen.
* Be between 18 and 80 years of age
* Be enrolled in the Cystinuria Registry.

Exclusion Criteria:

* You are not a patient with cystinuria
* You are not already taking a cystine binding thiol drug
* You have renal colic (if you are passing a stone)
* You are scheduled to undergo a urologic procedure
* You are unwilling or unable to provide informed consent in order to be able to participate.
Psychometric Validation of a French Version of the PISQ-R and a New Questionnaire About Sexuality

The primary objective of this study is the psychometric validation of two questionnaires (PISQ-R and a new questionnaire on sexuality) as compared to a non specific questionnaire on female sexual function (FSFI).


Eligibility Criteria:
Inclusion Criteria:

* Patient is not pregnant
* Patient can read and understand French
* The patient must have given her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient has genital prolapse and/or urinary incontinence and/or anal incontinence, and have undergone surgery

Exclusion Criteria:

* The patient is under judicial protection
* The patient does not understand french
* Patient has vulvodynia
* Patient has painful bladder syndrome
* The patient has had chronic pelvic pain for longer than 6 months