cyrilzakka/clinical-trials huggingface dataset:
Effect of Rapeseed Oil and Sunflower Oil

Familial hypercholesterolemia (FH), an inherited disorder of lipoprotein metabolism, is a risk for early cardiovascular disease (CVD). This autosomal dominant disease is characterized by markedly elevated plasma concentrations of low density lipoprotein (LDL) and total cholesterol (TC). The purpose of this study is to compare the effect of a diet low in saturated fats but enriched either with rapeseed oil (RO) or sunflower oil (SO) in children and adolescents with FH on serum lipoproteins.


Eligibility Criteria:
Inclusion Criteria:

* chilren and adolescents between 6 and 18 years of age
* LDLc \> 130 mg/dl and
* TC \> 200 mg/dl
* 7 day nutrition record
* written informed consent

Exclusion Criteria:

* overweight
* underweight
* mental disability
* drug therapy
Database Study on Patients With PCOS

All newly referred patients with PCOS and hirsutism are listed in a database.

All premenopausal women referred to the outpatient clinic at the Department of Endocrinology from 1997 and onward with the referral diagnoses hirsutism and/or PCOS are included in a clinical database. The patients should fulfill the Rotterdam criteria for PCOS or have clinical/biochemical hyperandrogenemia.

Routine evaluation include medical history, clinical examination, transvaginal ultrasound (US), and fasting blood samples. Cycle history is recorded in all patients using a standard scheme prepared for hirsute patients. Blood tests include androgens, LH, FSH, prolactin, and lipid profile.

OGTT and ACTH are performed in high risk patients

Eligibility Criteria:
Inclusion Criteria:

* premenopausal
* hirsutism or PCOS
Assessment of Vivity With French Clinical Data Related to the Toric Model Study

Presbyopia-correcting implant (PC-IOL): AcrySof IQ Vivity (Alcon) has been evaluated in 2 large pivotal trials (US and OUS trials). These tests showed that this PC-IOL restored intermediate visual acuity (IVA) and near visual acuity (NV A) superior to that of the reference monofocal AcrySof implant. In these tests, it was demonstrated that distance visual acuity (DVA) was non-inferior. However, the intermediate visual acuity for this implant in its toric version has not been evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patient presenting for a request for cataract surgery in current practice: phacoemulsification followed by classic implantation of an IOL with small incision size (\< 2.2mm)
* Calculated power of IOL is between 10.0 and 30.0 diopters (D) in 0.5D steps to target emmetropia (0.0 +/- 0.5D)
* Patients with corneal astigmatism \> 0.5D and who can receive an implant with a toricity between T2 and T6, i.e. with astigmatism between +0.5D and +2.5D.
* If both eyes have astigmatism, the eye under study will be the right eye
* Patient having been informed and not objecting to their participation.

Exclusion Criteria:

* Pregnancy or breastfeeding while conducting the study
* Person under the age of 18
* History of pathologies of the anterior segment of the eye (cornea, anterior chamber, sulcus) or posterior segment of the eye (uvea, vitreous, retina) including retinal vascular occlusions, retinal detachment, peripheral retinal laser photocoagulation, AMD and glaucoma
* Any inflammation of the anterior or posterior segment, whatever its etiology or history of disease, which may lead to an inflammatory reaction
* Clinically significant corneal pathology (epithelial, stromal, or endothelial that could affect visual outcome)
* Clinically significant severe dry eye disease that may affect visual calculations and measurements
* History of refractive surgery
* Amblyopia or monofixation syndrome
* Patient at risk of zonular rupture during the phacoemulsification procedure and may affect the centering or tilt of the implant postoperatively.
* Irregular astigmatism (corneal topography)
* Any other planned eye surgery
A Phase I/II Clinical Trial of ICP-723 in the Treatment of Advanced Solid Tumors

A Multicenter, Nonrandomized, Open-Label Phase I/IIClinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients with Solid Tumors

Solid Tumors

Eligibility Criteria:
Inclusion Criteria:

1. Histopathologically confirmed surgically unresectable locally advanced or metastatic solid tumors or primary central nervous system (CNS) tumors..
2. Age:

   Adult Cohort: Age ≥ 18 years; Adolescent cohort: 12 ≤ years \< 18 years.
3. At least one measurable lesion as per RECIST1.1 criteria, or for primary CNS tumors, at least one measurable lesion as per RANO or INRC criteria.
4. Adult cohort: ECOG PS score of 0-1;
5. Adolescent cohort: Karnofsky (age ≥ 16 years) or Lansky (age \< 16 years) PS score \> 60.
6. Life expectancy \> 3 months.
7. Female patients or male patients of childbearing potential, who agree to use medically acceptable effective methods of birth control throughout the study up to 12 weeks after the last dose of the study treatment.
8. Patients who have signed the Informed Consent Form voluntarily and agree to follow the therapeutic regimen and the visit schedule.

Exclusion Criteria:

1. Any other active malignancy within 5 years prior to the first dose of the study drug.
2. Prior anti-cancer treatment within 28 days prior to the first dose.
3. Major surgical procedures within 4 weeks or minor surgical procedures within 2 weeks prior to the first dose of the study drug.
4. A history of allergic disease, severe drug allergy, known hypersensitivity to any component of the ICP-723 tablet formulation.
5. Other situations that, in the investigator's opinion, would make the subject unsuitable for participation in the study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Comparison of the Efficacy and Safety of AtorVastatin mOnotherapy vs. Combination Atorvastatin/Fenofibric Acid

The purpose of this study is to compare combination atorvastatin/fenofibric acid 10/135mg with atorvastatin 20mg monotherapy in the mixed hyperlipidemia who were not at lipid goals with atorvastatin 10mg monotherapy.

Study conduct according to the standard operating procedure

* The sponsor, the investigator, and all other persons involved in the study at the study center or other facilities should conduct the study in accordance with the study protocol, each standard operating procedure, and Korea Good Clinical Pratice.

Data quality control

* In order to ensure the reliability of all study-related data and their appropriate processing, the sponsor will apply quality control to each step of data handling

Monitoring

* In order to confirm that the study is being conducted, recorded and reported according to the study protocol and International Conference on Harmonization Good Clinical Practice(ICH-GCP), the sponsor or CRO will perform monitoring of study procedure. In monitoring, the monitors will cross check the description in the case report form, etc. against study-related records such as source documents to confirm that the description is accurate.

Measures taken to cope with adverse events and reporting procedure

* The investigator should notify the event to the sponsor or Contract Research Organization(CRO) immediately (within around 24 hours) after having noticed the occurence of a serioius adverse event by telephone, fax or E-mail. The investigator should complete and submit an serioius adverse event(SAE) report form containing all information to the Institutional Review Board (IRB).

Data Management

* In this study, data will be collected in electronic Case Report Form(CRF)
* Data validation for missing data will be managed by computer programming and manual check.

Eligibility Criteria:
Inclusion Criteria:

* patients of the age of 20years or older
* patients who have been taking atorvastatin 10mg 1 tab per day for more than 8 weeks before screening
* patients who meet the following criteria

  1. Low density lipoproteins-cholesterol level \< 130mg/dL
  2. 150mg/dL \< Triglyceride level \< 500mg/dL
  3. HDL-cholesterol level \< 45mg/dL
* patients who consent for the consent before enrolling the study

Exclusion Criteria:

* Allergic to HMG-CoA reductase inhibitor and fibrates
* uncontrolled Hypertension
* unstable angina, myocardial infarction, transient ischemic attack
* uncontrolled diabetes
* thyroid disease
* myopathy, rhabdomyolysis history
* alcoholic
* chronic diarrhea, gastrointestinal disease
* malignant tumor
* patients who are pregnant
* lactating woman
Analgesic Ointment on Temporomandibular Joint and Masticatory Muscle Pain

The purpose of this study is to compare the effectiveness of using topical cream of Ping On Ointment and using Vaseline cream in the treatment of temporomandibular joint (TMJ) and masticatory muscle pain, in order to establish the true efficacy of Ping On Ointment. Both Ping On Ointment and Vaseline are considered intervention.

Aims: To compare the effectiveness of using topical cream of Ping On Ointment and using Vaseline cream in the treatment of temporomandibular joint (TMJ) and masticatory muscle pain, in order to establish the true efficacy of Ping On Ointment. Methods: In this randomized, double-blinded, placebo-controlled trial, 55 subjects with TMJ and/or masticatory pain (Group 1 patients according to the Research Diagnostic Criteria for Temporomandibular Disorder (RDC/TMD) received Ping On Ointment for 4 weeks; or placebo for 4 weeks. Subjects were evaluated with standard measures of efficacy: pain intensity measured by visual analogue scale and maximal comfortable mandibular opening, at baseline and again after 4 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Self report of facial ache or pain in the muscles of mastication, the TMJ, or the region in front of ear or inside the ear
2. Positive clinical diagnosis of TMDs. The TMD diagnosis is classified using axis I of the research diagnostic criteria ( RDC) for TMDs. The RDC diagnosis consists of joint pain at rest ( spontaneous pain) and evoked pain (hyperalgesia) on palpation of the TMJ, TMJ reduction consists of reciprocal clicking or joint noise with mandibular movement examination.
3. For joint pain complaint, subjects will be required to have a self-report of at least 1 month of daily or nearly-daily pain.
4. Subjects with myogenic pain will be included if they meet inclusion and exclusion criteria since patients with TMDs are known to exhibit muscle pain secondary to their joint dysfunction.

Exclusion Criteria:

1. Subjects with infectious arthritis, crystal induced arthropathies, musculoskeletal disorders, subjects with a primary diagnosis of myofascial pain based on the RDC;
2. Subjects with pain attributable to confirmed migraine or head pain condition other than tension headache;
3. Subjects with acute infection or other significant disease of teeth, ears, eyes, nose or throats; subjects with untreated depressive disorder or not on stable antidepressant medication for more than 6 months;
4. Subjects with dental diseases that required ongoing treatment, which would confound the evaluation of orofacial pain;
5. Subjects who are not competent in giving consents.
6. Pregnant or lactating women
7. Subjects with sensitivity to the ingredient of Ping On Ointment will be excluded.
Multi-centre Clinical Trial on Hormone Replacement Treatment in China

This study is to evaluate the benefit/risk of hormone replacement treatment among early menopausal women in China. This is a multi-centre, random, prospective study.


Eligibility Criteria:
Inclusion Criteria:

* going through amenorrhea above 6 months and within 5 years,
* aged 40 to 60 years,
* going though postmenopausal symptoms,
* serum E2 concentration \<30pg/ml,
* serum FSH concentration \>40IU/L.

Exclusion Criteria:

* uterine fibroid diameter≥5cm,
* history of diabetes or hypertension,
* history of thromboembolism, severe endometriosis, epilepsy, asthma, hyperprolactinemia,
* first degree relative had a history of breast cancer,
* being in severe or unstable condition of somatic diseases,
* receiving HRT in the past 3 month,
* drug or alcohol abuse in the past 3 month,
* endometrial thickness ≥0.5cm after withdrawal bleeding,
* being allergic to the medicine,
* participating in other clinical trials within 1 month ago.
The Role of Microbiota on the Development of Lung Cancer

Relationship between human microbiota and epidemiology of lung cancer

In this study,We aim to find some kinds of human microbiota , which were associated with development of non-small cell lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* non-small cell lung cancer patients

Exclusion Criteria:

* long-term workers in the polluted environment, Patients who had used antibiotics within 1 month before sampling,
Wheelchair-bound Senior Elastic Band (WSEB) Exercise Program for the Demented Seniors

The goals of this three-year research project were: 1) to develop and evaluate the feasibility of the Wheelchair-bound Senior Elastic Band (WSEB) for the demented, wheelchair-bound seniors in long-term care facilities, 2) to evaluate the long-term effects of the instructor-led WSEB on the functional fitness, daily life function, depression, and problem behaviors of this senior population, and 3) to test the feasibility, compliance, and effectiveness of the DVD-led WSEB on this senior population.

A three-year, longitudinal, triangulation research method was applied. First Year (Phase I): A preliminary WSEB, including hard copy descriptions and DVD demonstrations of each exercise, were sent to the 12 experts in the Delphi advisory panel for their critique and evaluation. First Year (Phase II): A quasi-experimental, one-group, pretest-posttest design was used to pilot-test the feasibility of the WSEB on a group of 15-20 demented, wheelchair-bound seniors in long-term care facilities. Second Year: A quasi-experimental, pre-post tests, non-equivalent control group design was used to test the long-term effects of the instructor-led WSEB on the functional fitness (cardiovascular-respiratory function, body flexibility, range of the joint's motion, and muscle strength and endurance), daily life function, depression, and problem behaviors of the demented, wheelchair-bound seniors in long-term care facilities. Eight long-term care facilities with 150 demented, wheelchair-bound seniors from southern Taiwan were recruited and randomly assigned based on the facilities to a WSEB experimental group or a waiting-list control group. Participants in the experimental group received the WSEB lead by the pre-trained and certified instructors, three times per week, 40 minutes per practice for 24 weeks; participants in the waiting-list control group remained regular activities in the facilities. One pre-test and two post-tests, 12 weeks apart, were conducted. Third Year: Using the same method as in the second year, participants from the second year were continued practicing the WSEB, but guided by a DVD, for another 36 weeks. The feasibility, compliance, and effectiveness of the DVD-led WSEB on the demented, wheelchair-bound seniors in long-term care facilities were tested, and another three post-tests, 12 weeks apart, were conducted on the same outcome measurements as in the second year.

Eligibility Criteria:
Inclusion Criteria:

* aged 65 and over
* diagnosed with dementia by a physician or screened by the Mini-Mental State Examination (MMSE) as dementia
* wheelchair-bound seniors
* living in the long-term care facility for at least three months

Exclusion Criteria:

* having severe and acute cardiovascular, musculoskeletal, or pulmonary illnesses
* suffering from spinal cord injury with no rehabilitation potential
Magnetic Resonance Imaging (MRI) Viability: Comparison of Myocardial Viability by Positron Emission Tomography and MRI

The purpose of this study is to compare cardiac MRI with positron emission tomography (PET) with fluorodeoxyglucose (FDG) to determine if cardiac MRI images are as good as, or better, than PET with FDG.


Eligibility Criteria:
Inclusion Criteria:

* PET-FDG ordered to assess myocardial viability

Exclusion Criteria:

* Contraindicated for MRI
* Pregnant
* Age \<25 yrs
Tucaresol As Add-On To HAART (Highly Active Antiretroviral Therapy) In Chronic HIV-1 Infected Adults

This is a pilot study designed to determine a dose and schedule of Tucaresol that can be administered to HIV-1 infected subjects on HAART (highly active antiretroviral therapy) with viral suppression without occurrence of significant adverse events and that results in significant changes in cell mediated immunity.


Eligibility Criteria:
Inclusion Criteria:

* Currently on licensed triple combination therapy, which is defined as two nucleoside analogues (2 NRTI) (excluding Abacavir) and a protease inhibitor (PI) (including boosted PI regimens) or non nucleoside reverse transcriptase inhibitor (NNRTI).
* Must be on the same treatment for at least 3 months prior to study without plans to alter therapy for the next 3 months.

Plasma HIV-1 RNA (ribonucleic acid)\< 50 copies/mL at screening with a documented history of continuous suppression defined as: the last two readings \< 50 copies/mL for a period of at least 3 months prior to screening.

* Documented CD4+ lymphocyte cell count =350 cells/ml at screening with at least one reading =350 cells/mL in the preceding 3 months and CD4 nadir \>200 cells/ml.

HBsAg (human hepatitis B Virus surface antigen) and HCV-Ab (human hepatitis C Virus antibody) negative.

Exclusion Criteria:

* History of hyperimmune or allergic reactions to drug treatment within 3 months prior to study.
Evaluation of Adjuvant Hormonal Treatment for 24 Months After Radical Prostatectomy in High Risk of Recurrence Patients.

PRINCIPAL OBJECTIVE: Evaluation of effectiveness in terms of survival without metastases to 10 years, of adjuvant hormonal treatment with leuprorelin acetate (Eligard® 45 mg) for 24 months after radical prostatectomy in patients with high risk of recurrence.

SECONDARY OBJECTIVE(S):

* PSA evolution
* Evaluation of testosterone level
* Specific survival
* Overall survival
* Tolerance
* Quality of life (QLQ-C30 questionnaires)


Eligibility Criteria:
Inclusion Criteria:

1. Patients who have received the information leaflet and signed the consent form
2. ≥18 years of age with a life expectancy of at least 10 years
3. Performance Status (ECOG) ≤2
4. Radical prostatectomy (RP) with or without extended pelvic lymphadenectomy in the 3 months preceding inclusion
5. Histologically confirmed prostatic adenocarcinoma
6. Patients R0, N0 or Nx or N+ (≤ 2 nodes among nodes removed), M0 and with at least one of the following criteria:

   * postoperative Gleason score \>7
   * postoperative Gleason score =7 with the presence of high-grade Gleason patterns
   * pT3b patients
7. Postoperative PSA \<0.1 ng/mL (dosage perform within 2 months after surgery)
8. Neutrophils ≥1500/mm³, platelets ≥100000/mm³
9. Bilirubin ≤ upper normal limit (this will not apply to subjects with Gilbert's syndrome, persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of evidence of hemolysis or hepatic pathology); ASAT and ALAT ≤1.5 times upper normal limit; Creatinine \<140 µmol/l (or clearance \>60 mL/min)
10. Patients affiliated to a social security scheme

Exclusion Criteria:

1. Previous treatments for prostatic adenocarcinoma (HT or orchiectomy or CT)
2. Presence of metastases:

   * positive bone scintigraphy, including Patients with medullary compression and/or
   * abdominal-pelvic CT scan or MRI showing lymph node and/or visceral involvement
3. History of cancer, with the exception of basal cell carcinoma or any other cancer treated in the 5 years before inclusion and in complete remission
4. Incompatible concomitant treatment(s)
5. Hypersensitivity to other GnRH agonists and/or any of the excipients of Eligard®
6. Any illness or problem including geographic, psychiatric or psychological which is incompatible with being monitored during the trial
7. Persons deprived of their freedom or under supervision (including guardianship),
8. Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within a period of 30 days
The Clinical Character，Risk and Prognosis of Post-neurosurgical Intracranial Infection With Different Pathogens.

Intracranial infection is one of the common clinical complications after neurosurgery, especially after external cerebrospinal fluid drainage. Postoperative intracranial infection has a very high incidence, and its incidence is about 0.34%-3.1%. Once infection occurs, it will directly affect the length of hospitalization, mortality and disability of postoperative patients. The pathogenic bacteria of postoperative intracranial infections include G-bacteria and G+ bacteria, and fungi. Common G+ bacteria are Staphylococcus aureus. Common G-bacteria are Acinetobacter baumannii, Klebsiella pneumoniae, and Pseudomonas aeruginosa Bacteria, Escherichia coli and so on. In recent years, studies have reported that postoperative intracranial infections of G-bacteria are gradually increasing. In the previous study of our research group, it was found that Acinetobacter baumannii and Klebsiella pneumoniae accounted for the top two pathogens of postoperative intracranial infections in ICU. In particular, the proportion of carbapenem-resistant G-bacteria has increased, which brings difficulty and challenge to the treatment and seriously affects the prognosis of patients. Different pathogen infections may lead to different prognosis of patients with intracranial infection after neurosurgery. With different pathogens as the starting point, there are few studies comparing the clinical features, risk factors, and prognosis of intracranial infections after neurosurgery. Therefore, it is great significant to explore and understand different pathogenic bacteria, risk factors, drug resistance, treatment options, and prognosis after neurosurgery.

1. To study the epidemiological distribution of pathogenic bacteria of intracranial infection after neurosurgery.
2. To study the risk factors of intracranial infection after neurosurgery (operations, type of external drainage tube, days of drainage tube , etc.).
3. To compare differences in clinical character，risks , treatment options, prognostic indicators between G+ bacterial infection group and G-infected bacterial group after neurosurgery.

Eligibility Criteria:
Inclusion Criteria:

- Patients diagnosed with intracranial infection after surgery and positive pathogenic microorganisms cultured in cerebrospinal fluid

Exclusion Criteria:

* (1) \< 18 years old, (2) Pregnant or lactating women, (3) fungus in CSF culture, (4) Clinical judgment is not intracranial infection, and CSF culture positive considers contaminating patients.