cyrilzakka/clinical-trials huggingface dataset:
Diagnosis, Treatment Status and Prognosis of Cholangiocarcinoma in China: a Multicenter, Two-way, Non-intervention Study

This is a multicenter, two-way, non-intervention study. the main purpose: Understand the current status of diagnosis and treatment of cholangiocarcinoma patients in China and observe the effect of different treatment options on patient recurrence and long-term survival

Secondary purpose:

1. Exploring the actual clinical treatment situation and its compliance with the existing diagnosis and treatment of bile duct cancer
2. Exploring the establishment of clinical research standard fields and standards for diagnosis and treatment of bile duct cancer


Eligibility Criteria:
Inclusion Criteria:

1. above the age of 18 years old, male or female
2. clinical diagnosis of patients with cholangiocarcinoma
3. Child-Pugh classification of A, B
4. Eastern Cooperative Oncology Group scoring system (ECOG) score of 0-2 points

Exclusion Criteria:

* None
Granulocyte Colony Stimulating Factor for for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer

This study aims to analyze the effects of long-acting versus short-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in epithelial ovarian cancer patients.

Patients receive platinum-based chemotherapy of 3 to 4 weeks. Patients are randomized into study group and control group. In study group, patients accept long-acting G-CSF 48 hours from the chemotherapy. While the control group accept regular or prophylactic treatment of short-acting G-CSF according to National Comprehensive Cancer Network guidelines.

The primary end is the incidence of FN in every course of chemotherapy.

The secondary ends include: the incidences of myelosuppression, doses of G-CSF and its expenses, visits to outpatient and emergency clinics, adverse events related to G-CSF, quality of life, and survival outcomes (progression-free survival and overall survival).


Eligibility Criteria:
Inclusion Criteria:

* With definitive pathological results of epithelial ovarian cancer
* With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2
* Aged 18 or older
* Receiving 3-4 weeks per cycle of platinum-based chemotherapy with or without debulking surgery
* Regularly followed up in the study centers
* Provided consent for participation.

Exclusion Criteria:

* Failure to meet all the inclusion criteria
* Non-compliance with the study protocols
* With a history of chemotherapy or pelvic radiotherapy for malignancies
* Presence of immunosuppressive diseases such as organ transplantation or acquired immune deficiency syndrome
* Treated with weekly chemotherapy regimens
* Presence of hematological disorders
Safety and Tolerability Study of LBS-008 in Healthy Adult Subjects After Single and Multiple Doses

This is a single center, randomized, double-blind, placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study is planned to assess safety, pharmacokinetics (PK), and pharmacodynamics of LBS-008 in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

* The subject is male or female, 18 to 65 years of age, inclusive, at screening.
* The subject voluntarily consents to participate in this study and provides written informed consent before the start of any study-specific procedures.
* The subject is willing and able to remain in the study unit for the entire duration of the confinement period and return for outpatient visits.
* Female subjects must be of nonchildbearing potential (defined as surgically sterile \[i.e., had a bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months before the dose of study drug\] or postmenopausal for at least 1 year before study drug administration confirmed by FSH test at screening; FSH level \>40 mIU/mL). Female subjects may also be considered of non-childbearing if they have a confirmed medical condition which would deem the subject as infertile. E.g. MRKH Syndrome (Mullerian Agenesis) or another applicable condition.
* Male subjects must be surgically sterile (i.e., vasectomy) for at least 3 months before screening; or remain abstinent or agree to use a highly effective form of contraception when sexually active with a female partner for 90 days after study drug administration. Highly effective contraception requires use of a condom and appropriate contraceptive measures for your female partner (i.e. oral, injected or implanted hormonal methods, or placement of an intrauterine device or intrauterine system). This requirement does not apply to subjects in a same sex relationship and female partners of non-childbearing potential.
* The subject has a body mass index (BMI) of 18 to 30 kg/m2, inclusive, and weighs 50 to 100 kg (110 to 220 pounds), inclusive, at screening and check-in.
* The subject is considered to be in stable health by the investigator.
* The subject agrees to comply with all protocol requirements.

Exclusion Criteria:

* Any significant acute or chronic medical illness including history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease
* Vitamin A deficiency.
* Any recent viral or bacterial infection.
* Participated in any clinical study in last 6 weeks.
* History of significant drug allergy
* History of significant vision, ocular or retinal disorder.
* Recent surgery, blood transfusion, drug or alcohol abuse and use of tobacco or nicotine containing products in past month.
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations Other protocol-defined inclusion/exclusion criteria could apply.
Prospective Evaluation of an Hydrophilic Acrylic Intraocular Lens

Evaluation of the clinical safety and effectiveness of an hydrophilic acrylic intraocular lens

To show safety and the effectiveness in regard to the monocular corrected distance visual acuity (CDVA) and the distance-corrected near visual acuity (DCNVA) at 6 months postoperative.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of any gender, aged 18 years or older
2. Patient is planned for aged-related cataract surgery and implantation of the study IOL into the capsular bag in at least one eye
3. Patient is willing and capable of providing informed consent
4. Patient is willing and capable of complying with visits and procedures as defined by this protocol

Exclusion Criteria:

1. Preoperative corrected distance visual acuity (CDVA) better than 0.3 logMAR (0.5 decimal)
2. Endothelial cell count of less than 2000/mm2
3. Ocular disorder that could potentially cause a clinically significant future visual acuity loss
4. Preoperative corneal astigmatism ative corneal to be \< 1 D.
5. Clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.)
6. Clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
7. Any clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)
8. Any History of clinically significant retinal pathologies or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) that could alter or limit final postoperative visual prognosis
9. Any acute infection (acute ocular disease, external/internal infection, systemic infection)
10. Any previous intraocular and corneal surgery
11. Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment
12. Current systemic or ocular pharmacotherapy that effects patients'vision
13. Current pathology or condition that could be a risk for the patient according to the investigator opinion
14. Women during pregnancy and/or lactation
15. Patients unable to meet the limitations of the protocol or likely of noncooperation during the trial
16. Patients whose freedom is impaired by administrative or legal order
17. Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, that do not affect patients'vision
Lung Diffusing Capacity for Nitric Oxide During Cycling Exercise

This study investigates the test-retest reliability of the lung diffusing capacity for nitric oxide in healthy individuals during exercise.

The aim of this study of to evaluate the test-retest reliability of single-breath lung diffusing capacity measurements for nitric oxide (DLNO) in healthy individuals during light and moderate intensity cycling exercise. Healthy subjects will perform repeated single-breath DLNO measurements during light (i.e., at 50% of the first ventilatory threshold) and moderate intensity exercise (i.e., 80% of the first ventilatory threshold) on a stationary cycle ergometer.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Age 18 yrs and older
* Ability to follow study procedures and instructions in German

Exclusion Criteria:

* Any known cardiopulmonary or metabolic diseases (e.g., heart disease, diabetes mellitus etc)
* Obesity (BMI \> 30kg/m2)
* Smoking (ex-smoker allowed; if they stopped smoking at least one year before the examination)
* Mental impairment leading to inability to cooperate
* Respiratory infection in the last two weeks
* Forced expiratory volume in 1s/ forced vital capacity (FEV1/FVC ratio) FEV1/FVC ratio \< lower limit of normal according to equations by Quanjer et al. Eur Respir J 2012.
A Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Briquilimab in Participants with Allergic Asthma

Study JSP-CP-012 is designed as a proof of concept, parallel-group, single dose, double blind, placebo-controlled study using an allergen challenge model. A single dose proof of concept approach at a dose level shown to be biologically active should inform the impact of briquilimab on allergic asthma as compared to placebo while minimizing exposure to participants, in a new indication.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 to 65 years of age; stable, allergic asthma; history of episodic wheeze and shortness of breath; forced expiratory volume in 1 second (FEV1) at baseline at least 70% of the predicted value; able to comprehend and follow all required study procedures; willing and able to sign an informed consent form; positive methacholine challenge at baseline (concentration of methacholine causing 20% decrease in FEV1 \[PC20\] PC20 ≤ 16 mg/mL or PD20 equivalent to ≤400µg); and positive skin-prick test and positive allergen-induced early and late airway bronchoconstriction to common aeroallergens.

Exclusion Criteria:

* Worsening of asthma or respiratory infection in the preceding 6 weeks; lung disease other than allergic asthma; prior treatment with a c-Kit inhibiting therapy; anaphylaxis to any parenterally administered biologics; use of asthma medications (note: intermittent doses of short-acting β2-agonist are allowed once weekly for relief of symptoms but prophylactic use for exercise is allowed as-needed); pregnant or lactating women; and women actively seeking pregnancy or who are not using adequate contraception.
Primary Angle Closure Glaucoma and Aqueous Dynamics

The aim of the study is to determine which is the best treatment for people with cataract and primary angle closure (PAC).In PAC, apposition of the iris tissue to the drainage channels (Trabecular Meshwork-TM) of the eye results in damage and formation of adherences between these structures (Peripheral anterior synaechiae-PAS) causing a mechanical obstruction of the aqueous outflow via the TM. It is thought that cataract surgery combined with mechanical separation of the iris from the TM with the breakage of PAS(we call this separation 'goniosynechialysis') would make the pressure even lower as it would cause the drain to open to a greater extent than cataract surgery alone. This technique is not new, and the results have been very encouraging. Comparing this technique to cataract surgery alone however, has not been done and this is exactly what we would like to do in order to help us decide what is the best treatment.

In summary, the investigators propose that cataract surgery with goniosynechialysis would lower intraocular pressure to a greater extent than cataract surgery alone in patients with significant PAS.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 21 years.
* Diagnosis of PAC or PACG. PACG is defined as glaucomatous optic neuropathy in the opinion of a fellowship-trained glaucoma specialist, together with an IOP \> 21mmHg on at least one occasion, and reproducible visual field defect (using the 24-2 test pattern on a Humphrey Field Analyser). PAC has all the above characteristics except for the visual field defect.
* More than 90 degrees of PAS (not necessarily contiguous).
* Lens opacity deemed sufficient to be causing decreased vision in the opinion of the supervising consultant (KSL).
* Ability to give informed consent.

Exclusion Criteria:

* Previous intraocular surgery or keratorefractive surgery.
* Previous eye trauma resulting in documented damage to the drainage angle (such as angle recession).
* History of uveitis.
* For patients on warfarin, INR \>3.0 on day of surgery.
* Anterior segment neovascularisation.
* Chronic use of topical or systemic steroids.
New Genes in the Carcinogenesis of Colorectal Cancer

Colo rectal cancer is one of the greatest ,mutual malignancies worldwide ,accounting for an estimated 1.3 million new cases and \>500,000 mortality ⁄ year . is the fourth leading cause of cancer-associated mortality worldwide with speedily ,cumulative ,occurrence rate in the worldwide

colo rectal cancer represents a global and local problem, as it is one of the commonest types of cancer all over the world. Globally, Colo rectal cancer in women (9.2% of diagnoses) it is the second most common cause of cancer . it is the third most common in men (10.0%). After lung, stomach, and liver cancer it is the fourth most common cause of cancer death.

Cancer is a multistep procedure resulting from an ongoing accretion of genetic and epigenetic fluctuations to the genome.

Spartin is a protein that in humans is encoded by the SPG20 gene. This protein may be involved in endosomal trafficking, microtubule dynamics, or both functions. Aberrant promoter methylation of genes is a common epigenetic alteration in colo rectal cancer .

This has stimulated the prospect to implement a dependable, reasonable and simple approach for Colo rectal detection . The SPG20 gene is situated in chromosome band 13q13.3; the SPG20 gene converts the spartin protein, which is a multi functional protein that has formerly been recognized to be complicated in intra cellular epidermal growth factor receptor trading , The serine-threonine kinase 31 (STK31) gene was initially identified through cDNA subtraction as a testis-specific protein kinase gene expressed in mouse spermatogonia . Recently, STK31 has been described as a novel cancer testis (CT) antigen, highly expressed in Gastrointestinal cancer cells (colo rectal, gastric and esophageal cancer), while restricted to testis and fetal brain in normal tissues .

It was found that SPG20 is mutated in Troy er syndrome, an hereditary spastic paraplegia

Eligibility Criteria:
Inclusion Criteria:

* age between 35-65
* patient with colorectal cancer (at any stage)
* both sex included

Exclusion Criteria:

* pediatric patients
* patient with insufficient data
* cardiac patient
* pregnant women
Predicting Outcomes of Cardiac Surgery-associated Acute Kidney Injury Using Biomarkers At Initiation of RRT

The aim of this study was to verify the prognostic value of functional kidney biomarkers on survival and renal function recovery in cardiac surgery patients with acute kidney injury.

Cardiac surgery-associated acute kidney injury (CSA-AKI) is the second most common type of AKI after septic AKI and is associated with increased mortality and morbidity. Few biomarkers were validated as outcome-specific biomarkers in patients developing AKI after cardiac surgery at initiation of RRT. This study was designed to not only verify the prognostic value of functional kidney biomarkers on survival, but also predict it severity in order to optimize clinical decision making with respect to dialysis initiation and discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cardiac surgery who required renal replacement therapy.

Exclusion Criteria:

* History of End Stage Renal Disease or on Dialysis
* prior kidney transplantation
* patients with a DNR order or "do not escalate care" order
Personalized Mean Arterial Pressure Management on Renal Function During Septic Shock

Sepsis is the most severe complication of infections. Sepsis-associated Acute kidney injury (AKI) is commonly encountered in critically ill patients and independently predicts poor outcome. Unfortunately, no drug or management strategy was able to reduce incidence of AKI. To adapt the level of mean arterial pressure according to local renal hemodynamic evaluated by renal Doppler could lead to a better renal perfusion, and then less AKI.

Acute Kidney Injury (AKI) is a frequent and serious complication of sepsis. Renal ischemia plays a major role in the pathophysiology of sepsis-associated AKI. There is currently no treatment to prevent or to treat AKI. It has been shown that a resistivity index (RI) greater than 0.74 of patients with septic shock could predict the occurrence of renal failure, and that increase mean arterial pressure (MAP) with norepinephrine could decrease RI. Hence, we propose to compare the frequency and the severity of the sepsis-associated AKI according to the early hemodynamic management of septic shock. Patients will be randomized in a classic group (MAP 65 mmHg) and an interventional group (MAP 85 mmHg). We can thus determine whether the level of MAP influences renal function, and whether this influence of MAP is dependent of renal perfusion assessed by renal Doppler.

Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.

Primary endpoint:

-Presence and severity of sepsis-associated AKI at day 7.

Secondary endpoints:

* Acute renal failure measured by Classification AKI at day 28.
* Acute renal failure as measured by the RIFLE classification in the fourth to seventh day and 28th day.
* Use of renal replacement therapy during hospitalization in intensive care unit
* Mortality at day 28 Duration of study: Recruitment: 10 months, the patient monitoring: 28 days ± 3 days, total test duration: 11 months

Eligibility Criteria:
Inclusion Criteria:

* Any patient with septic shock may be included in the next 6 to 16h
* Age \> 18 years old and \<= 80 years

Exclusion Criteria:

* Chronic renal failure (Baseline serum creatinine \> 120 mmol/L)
* Chronic cardiac failure (Left ventricle ejection fraction \< 40%)
* Pregnancy
* Urinary Tract Infection
* Patients with a left ventricular dysfunction ( ventricular ejection fraction \<40%)
The Safety and Effectiveness of MK-639 and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

To compare the effects on CD4 counts and safety of MK-639 (indinavir, IDV) and AZT administered concomitantly to MK-639 alone and AZT alone in HIV-1 seropositive patients.

Patients are randomized to 1 of 3 groups for 12 months of treatment. Group 1 receives MK-639 plus AZT. Group 2 receives MK-639 alone. Group 3 receives AZT alone. Safety and tolerability are assessed by the incidence of clinical and laboratory adverse experiences. Blood and urine samples are collected for safety assessment and to determine CD4 cell counts and serum viral RNA levels. If therapy with MK-639 alone or with AZT is found to be generally safe and clinically efficacious, patients who have completed the study will have the opportunity to continue in an extension study protocol on a treatment regimen including MK-639.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV seropositivity.
* Average CD4 count between 50 and 500 cells/mm3 based on 2 separate pre-study determinations at least 1 week apart.

Note:

* Patients with known hemophilia may be enrolled at the discretion of the investigator.

Prior Medication:

Excluded:

* Any protease inhibitor.
* Significant prior use (greater than 2 weeks) of nucleoside analogues.
* Chronic therapy for an active opportunistic infection. (Allowed:
* Prophylaxis with aerosolized pentamidine, trimethoprim/sulfamethoxazole, dapsone, topical antifungals, and isoniazid).
* Investigational agents or immunomodulators within 30 days prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Acute hepatitis.
* Lymphoma.
* Visceral Kaposi's sarcoma.
* Invasive cervical cancer.
* Active infection.

Concurrent Medication:

Excluded:

Anticipated immunosuppressive therapy.
Early Feasibility Study of the Percutaneous Osseointegrated Prosthesis (POP)

The purpose of the clinical study is to characterize the efficacy and safety of a Percutaneous Osseointegrated Prosthesis (POP) device that can provide a satisfactory platform for direct skeletal attachment of prosthetic limbs, which includes a subdermal seal, thus allowing a proper biobarrier around the implant.


Eligibility Criteria:
Inclusion Criteria:

* US Military veteran with transfemoral amputation that is not a result of dysvascular disease
* Has used or is using a "socket suspension technology" prosthesis
* Use of non-propulsive, passive microprocessor-regulated devices
* Agrees not to participate in high levels of physical activity while in the study
* Subject meets anatomical and eligibility criteria for the investigational device

Exclusion Criteria:

* Currently on active military duty
* More than 1 limb amputated
* Has insulin dependent or adult onset diabetes
* Recent tobacco use
Effects of E-Cigarettes in Menthol Smokers

The current laboratory study examines e-cigarette preferences and smoking behaviors in menthol cigarette smokers.


Eligibility Criteria:
Inclusion Criteria:

* Daily cigarette smoking for at least the past 2 years
* Interest in trying e-cigarettes
* Report smoking mentholated cigarettes

Exclusion Criteria:

-- Pregnancy and/or breastfeeding