cyrilzakka/clinical-trials huggingface dataset:
Effect of Olive Leaf Extracts on Endothelial Dysfunction in Patients With Acute Coronary Syndrome

the study aims to examine the short-term (30 days) effects of olive leaf extract on endothelial function in patients with acute coronary syndrome (ACS).

This investigation will be conducted on patients admitted to the emergency department for ACS. All participants will be screened and included within 24 hours post-ACS event and prior to discharge from the emergency department.


Eligibility Criteria:
Inclusion Criteria:

Age over 18 years. Patients presenting with ST-segment alterations at rest, including ST elevation, with or without troponin elevation.

Patients who have not undergone surgery or have no additional primary percutaneous coronary intervention (P-PCI) planned within 8 weeks from the initial P-PCI.

Patients who provide informed consent. Patients available for and willing to adhere to follow-up procedures. Patients without significant cognitive impairment. Patients with a life expectancy of at least 2 years.

Exclusion Criteria:

* Severe LV hypertrophy (\>15 mm);
* Patients with any evidence of inflammatory or malignant disease.
* Patient having valvular heart disease, pacemaker; cardiogenic shock
* Patient having any serious non-cardiac disease associated with a life expectancy \<1 year
* Patients undergoing surgery within 30 days
* Patient having gastrointestinal disorder such as Crohn's disease
An Observational Study of Dutasteride and Alpha-blocker Combination Therapy in Men With Symptomatic Benign Prostatic Hyperplasia and PSA Level Over 4 ng/mL

To analyze the change in International Prostate Symptom Score (IPSS) and serum prostate-specific antigen (PSA) level from baseline.

This is a non-interventional, observational and multicenter study. When subjects will be allowed the dutasteride and α-blocker orally once daily for two years by investigator's prescription. They will be invited to this observational study. All eligible subjects can be allowed the prior alpha blockers therapy. Details of acute urinary retention (AUR) and BPH-related prostatic surgery episodes will be recorded at every visit. Subjects will return to the clinic for assessment every 3 months until week 96. The efficacy and safety of combining the 5α-reductase inhibitor (5ARI), dutasteride, and the α-blocker will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Males, age ≧ 50 years
* Clinical diagnosis of BPH by medical history and physical examination, including a digital rectal examination (DRE)
* IPSS score ≧ 8 points and prostate volume ≧ 30 mL
* Total serum PSA ≧ 4.0 ng/mL and ≦ 20 ng/mL at screening
* Previous TRUS-guided biopsy have been done with benign findings and with prostate cancer (CaP) not detected within the past 6 months.
* Dutasteride combination therapy will be allowed by investigator's prescription
* Ability to understand and willingly provide written informed consent

Exclusion Criteria:

* History or evidence of prostate cancer and high grade prostatic intraepithelial neoplasia (HGPIN)
* With symptomatic urinary tract or prostate infection or urinary retention within 3 months prior to entry of study
* Use of finasteride within 6 months of screening visit
* Use of dutasteride within 12 months of screening visit
Effect of an Oral Nutritional Supplement on Muscle Mass During Anticancer Treatment

Malnutrition and low muscle mass (sarcopenia) are common problems in patients with cancer. However, a low muscle mass is associated with negative clinical outcomes in patients with cancer. Therefore, it is very important to maintain muscle mass in this population. This study aims to investigate the effect of an oral nutritional supplement on skeletal muscle mass during anti-cancer treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stage III or IV colorectal or non-small cell lung cancer
* Scheduled for the first cycle of any line of a systemic treatment: chemotherapy, concurrent chemoradiotherapy, immunotherapy or targeted treatment with a planned duration of at least 9 weeks
* Performance status Eastern Cooperative Oncology Group (ECOG) score 0 or 1
* Age ≥ 18 years

Exclusion Criteria:

* Weight loss \>10% in the last 6 months
* Body Mass Index \> 30.0 kg/m2
* Life expectancy \< 3 months
* Receiving enteral (tube) or parenteral nutrition
* Presence of ileostoma or ileal pouch (except for an ileostomy at or near the terminal ileum which does not affect absorption of nutrients other than sodium, potassium, and water, in the opinion of the investigator)
* Allergy to cow's milk protein, soy or fish, requiring a fibre-free diet or suffering galactosemia or lactose intolerance
* Known pregnancy or lactation
* Current alcohol or drug abuse in the opinion of the investigator
* Wearing an electronic implant and/or pacemaker
* Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within 14 days prior to entry into the study
Modified MRCUKALLⅫ/ECOGE2993 Regimen for ALL

This prospective study was conducted to evaluate the efficacy and safety profiles of Modified MRCUKALLⅫ/ECOGE2993 Regimen in young adults with newly diagnosed, low-risk, Philadelphia chromosome negative acute lymphoblastic leukaemia.

All patients received a modified BFM regimen which was derived from the MRCUKALLⅫ/ECOGE2993 Regimen.The differences were as follows:(1) cranial prophylactic radiotherapy was omitted (2) Pegaspargase was used instead of L- asparaginase for patient.(3)Two additional Pegaspargase treatments were added into consolidation therapy.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed ALL
* age:18-35years
* WBC count below 30×109/L(B lineage)；WBC count below 100×109/L(T lineage)
* absence of t(9;22), t(1;19), t(4;11) or any other 11q23 rearrangements
* receive no chemotherapy or radiotherapy before
* Adequate renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)

Exclusion Criteria:

* mismatch the inclusion criteria
* systematic central nervous system involvement, previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.
Early Progesterone Cessation After in Vitro Fertilization

There seems to be a general consensus on the supplementation of progesterone (P4) for luteal phase support (LPS) to all women after in vitro fertilization (IVF) treatment. However, there is no agreement about the precise duration of LPS.

The objective of the study is to investigate the effect of early cessation of progesterone for LPS after IVF treatment on the pregnancy outcome, with special interest in determining the miscarriage rate and episodes of bleeding between the date of the first ultrasound (US) and up to 12 weeks of gestation.

Patients start to receive 200 mg twice a day of P4 on the day after oocyte retrieval.

All patients which show a gestational sac in their uterus in the first US are included in this study and randomized.

Inclusion criteria:

1. Patients who underwent ovarian stimulation using GnRH analogues,
2. Fresh embryo transfer,
3. LPS by vaginal micronized P4,
4. Clinical pregnancy demonstrated by US and
5. Informed consent signed.

Exclusion criteria:

Patients who had bleeding episodes before their first US because they are likely to continue P4 therapy without medical indication.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who underwent ovarian stimulation using GnRH analogues,
2. Fresh embryo transfer,
3. LPS by vaginal micronized P4,
4. Clinical pregnancy demonstrated by US and
5. Informed consent signed.

Exclusion Criteria:

Patients who had bleeding episodes before their first US because they are likely to continue P4 therapy without medical indication.
Impact of Implant Supported Overdenture on Changes of Electromyographic and Brain Activity

The purpose of this study is to evaluate and compare the effects of a mandibular implant-supported overdenture with a mandibular complete denture on electromyographic activity, brain activity, and cognitive performance in edentulous patients. Ten patients who are entirely edentulous and did not wear dentures will be chosen. To assess brain activity and cognitive function, electroencephalograms, the Mini-Mental State Examination (MMSE), and electromyographic examinations of the temporalis and masseter muscles will be performed prior to complete denture construction, one and three months after complete denture construction, and one and three months after implant supported overdenture insertion, respectively.


Eligibility Criteria:
Inclusion Criteria:

* All patients' ridges should be covered with firm mucosa which is free from any signs of inflammation or ulceration.
* Patients should be free from any bone disorder and exhibit adequate height and width of the residual alveolar ridge.
* All patients must have sufficient inter arch space.

Exclusion Criteria:

* Patients with oral or systemic diseases.
* Patients with xerostomia or excessive salivation.
* Patients with parafunctional habits (bruxism or clenching).
* Heavy smoker or alcoholic patients.
* Patients with history of temporo-mandibular dysfunction.
* Patients with neurological or psychiatric disorders.
NCRT Combined With Sequential Perioperative PD-1 Inhibitor for LAESCC

This study aims to examine the efficacy of the combination of neoadjuvant chemoradiotherapy and perioperative PD-1 inhibitor in patients with locally advanced esophageal squamous cell cancer and explore the predictive biomarkers for this regimen.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old
* Histologically or cytologically confirmed esophageal squamous cell cancer
* Stage T3-4aN0M0 or TanyN1-3M0 according to the American Joint Committee on Cancer staging manual eighth edition
* Eastern Cooperative Oncology Group performance status of 0 or 1
* he indexes of hematology, biochemistry and organ function meet the following requirements: a. white blood cell count (WBC) ≥ 3.0×109/L；b. neutrophil count (ANC) ≥ 1.5×109/L; c. platelets ≥ 85×109/L; d. hemoglobin ≥ 90g/L; e. total bilirubin ≤ 1.5 ULN; f. ALT ≤ 1.5 ULN; g. creatinine clearance rate \>60 mL/min;
* The cardiopulmonary function needs to meet the following criteria: EF ≥ 55%, VC \> 60%, FEV1 \> 1.2L, FEV1%\> 40%, DLco \> 40%
* Women of childbearing age must undergo a pregnancy test within 7 days before enrollment for treatment, and only those with a negative result can be enrolled
* Voluntarily participating in this study

Exclusion Criteria:

* Patients with active infection within 2 weeks before the first use of the study drug
* A history of interstitial lung disease or non-infectious pneumonia
* A history of autoimmune diseases or abnormal immune system
* Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction
* Patients diagnosed with any other malignant tumor within 5 years before enrollment, except for malignant tumors with low risk of recurrence and risk of death, such as fully treated basal cell or squamous cell skin and carcinoma in situ of the cervix;
* Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of Toripalimab, and the chemotherapeutic drugs nab-paclitaxel or cisplatin
* A history of immunodeficiency，including a positive HIV test result or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation
* Women during pregnancy or lactation
* Other situations not suitable for enrollment
Indocyanine Green Fluorescence During Fundus First Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy is the routine method for managing gallstone disease. This is considered a safe procedure with low risk of severe complications. Lesions to the deep bile ducts is, however, a rare complication from laparoscopic cholecystectomy that may have devastating consequences. The risk of bile duct injuries may be reduced by adapting the surgical approach. In general, the operation is started from the lower part of the gallbladder and continued upwards. It may, however, also be initiated from the top of the gallbladder and extended downwards. This approach, also termed fundus first, is routine at a few units.

By injecting Indocyanin Green (ICG) that is excreted into the bile, the bile ducts may be visualized using near infrared light. This is a technique for mapping the anatomical structures adjacent to the gallbladder that has been used in previous studies for preventing bile duct injuries. This method has, however, not been tested at units where fundus first is the routine surgical technique. In the present randomized controlled trial, the investigators intend to evaluate the safety of ICG as a means for reducing the risk of bile duct lesions and to see if it works as intended.

Altogether 294 operations for gallstones will be included in the study. The patients will be randomized to surgery with or without ICG. Regardless of the randomization, all operations will be undertaken with the fundus first technique.

Thirty days after the operation, all data related to the operation are retrieved from the patient records by an assessor that does not know what group the patient was randomized to. The primary endpoint of the study is the time required from the start of the operation until intraoperative cholangiography is done. In addition, total operative time, all surgical complications and need for converting the operation to an open procedure will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparoscopic cholecystectomy
* Verbal and written consent provided
* Age ≥ 18 years

Exclusion Criteria:

* Thyroid disease
* Allergy against ICG or Iodine
Advanced MR Techniques in Detection of Tumor Infiltration and Grading in Gliomas

In this study, we evaluate the role of diffusion kurtosis imaging (DKI) and MR spectroscopy (MRS), two advanced imaging techniques in magnetic resonance (MR) in grading and detection of microscopic infiltrating tumour in gliomas. These parameters are of utmost importance in optimal choice and planning of treatment.

Patients treated with gliomatous brain tumours are included voluntarily. They undergo one imaging session on a 3T MR scanner prior to treatment.

DKI data are quantitively analyzed in order to estimate specific parameters in normal appearing white matter, grey matter, tumor and peritumoral edema. MRS data are analyzed quantitatively and qualitatively with peak integration, ratio calculation and classification algorithms. Histological confirmation is obtained at subsequent surgery.

Information from this study can be of significant importance in avoiding brain biopsies. Furthermore, information on microscopic tumour spread can be used during neurosurgery or in radiotherapy planning. An important advantage of these advanced MR techniques is the non-invasivity and the lack of ionizing radiation, two important issues in this relatively young patient population.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of gliomatous brain tumour

Exclusion Criteria:

* younger than 18 years of age
* prior treatment
* history of neurological or neurosurgical treatment
Administration of Growth Hormone to Increase CD4+ Count in Patients Taking Anti-HIV Drugs

This study is designed to evaluate the ability of growth hormone (GH, also known as somatropin) to increase CD4+ cell counts in patients taking anti-HIV drugs. The study is targeted toward patients with low levels of HIV who continue to have low CD4+ cell counts.

After initiation of HAART, many HIV infected patients have significant improvement in CD4+ levels. However, some patients continue to have low CD4+ counts (\< 350 cells/mm3) despite adequate viral suppression. The purpose of this study is to determine whether administration of GH will increase naïve CD4+ production. Further, the study will assess whether an increase in naïve CD4+ production will lead to increases in antigen-specific CD4+ and CD8+ T cells.

Patients enrolled in this study will be randomized to one of two groups. Patients in both groups will continue their present HAART regimen for the duration of the study. Group A patients will receive daily subcutaneous injections of GH for 48 weeks. Group B participants will receive no additional therapy for 24 weeks, and will then receive daily subcutaneous GH injections during Weeks 24-28 of the study. Both groups will receive immunocyanin (keyhole-limpet hemocyanin) injections at Weeks 16 and 20 and hepatitis A vaccination at Weeks 40 and 44. At the conclusion of Week 48, all patients will discontinue GH therapy while maintaining their HAART regimen. Patients will then be followed for an additional 24 weeks.

Patients may be asked to participate in a substudy to measure the size of the thymus in people taking GH. Patients in the substudy will have a noncontrast CT scan of the chest before beginning GH therapy and again after 24 weeks of GH therapy.

Eligibility Criteria:
Inclusion Criteria

* HIV positive
* Minimum of 1 year of treatment with HAART
* CD4+ cell count \<350 cells/mm3
* HIV-1 RNA \<400 copies/ml for 6 months prior to study entry
* Acceptable methods of contraception

Exclusion Criteria

* Serious medical illness requiring hospitalization within 14 days prior to study entry
* Pregnant or breast-feeding
* Taking certain medications
* Allergy to r-hGH, hepatitis A vaccine, KLH, or their formulations, including allergies to shellfish
* Active drug or alcohol dependence
* Diabetes or uncontrolled hyperglycemia
* Uncontrolled hypertension
* History of carpal tunnel syndrome
* Active neoplasm requiring treatment
Efficacy of In-bag Morcellation

Laparoscopic mini-invasive surgery supplanted laparotomy for many years, including hysterectomy or myomectomy (less postoperative complications compared to laparotomy) However the US Federal Drug Administration (FDA) strongly warned against the use of power morcellation in 2014 because of the risk of iatrogenic spread of malignant cells.

The hypothesis is that in-bag morcellation may prevent cells dissemination. The investigator compare in this prospective randomized study two groups of patients: group A (in bag-morcellation during laparoscopic myomectomy or hysterectomy) versus group B (morcellation without any bag during laparoscopic myomectomy or hysterectomy)


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 years or more
* Laparoscopic myomectomy or laparoscopic subtotal hysterectomy
* Informed and signed consent

Exclusion Criteria:

* Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
* Preoperative risk of leiomyosarcoma or pelvic carcinoma
* Pregnancy or desire of pregnancy during the study period
* Uterus or myomas weight above 1.000 g
* Inability to understand information provided
* Not covered by a national health insurance scheme, prisoner or under administrative supervision
New Oxymetry Indices in Critical Limb Ischemia

Transcutaneous oxygen tension (TcpO2) at rest, sensitized by oxygen inhalation tests, is widely applied for the evaluation of chronic critical limb ischemia (CLI). If foot TcpO2 measurements are good prognostic factors of the risk of amputation or the probability of wound healing without amputation, they have never proven their hability to estimate the risk of death in patients with critical limb ischemia. On the one hand, studies have considered only the response observed on legs without considered the thoracic variations. On the other hand, the variability of the TcpO2 signal has never been analyzed as a prognostic factor.

The objective of the NOVICE study is therefore to assess, first, whether the variability of resting TcPO2 values at thoracic probe as well as at affected limb probe is a morbidity-mortality prognostic factor and secondly, to evaluate during the oxygen tests, if the measurement of the amplitude of the distal responses in ischemic zone compared to the response observed in thoracic probe is a prognostic factor of morbi-mortality.

This is an ambispective (both retrospective and prospective) cohort study in which any major patient, referred for resting (transcutyaneous oxygen pressure = TcpO2) for suspicion of critical limb ischemia, is included retrospectively and prospectively from November 2018 to October 2020. Tcpo2 recording are analysed to determine specific parameters (signal variability and response top oxygen). A morbidity-mortality follow-up is carried out between 12 and 15 months after the Tcpo2 measurement. A Kaplan Mayer study of these indices against MALE (major adverse lower limb events ) and MACE(Major adverse cardiovascular events) will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* Suspicion of Critical limb ischemia
* Reffered for Tcpo2 Absence of rebuttal to the use of the data by the patients

Exclusion Criteria:

* No available tcpo2 recording
* Rejection of the follow up by the patients
Night Myopia and Dark Focus of Accommodation

Shifts in accommodation at decreasing luminance levels are considered as principle cause for night myopia. Previous studies with laser optometers quantified the dark focus of accommodation up to 3 D. In addition to the measurement of dark focus, the aim of this study was to investigate the influence of an imaginary target at finite distances on the state of accommodation at scotopic luminance.

Accommodation was measured by using an open-field autorefractor (WAM 5500, GRAND SEIKO). Full corrected right eyes of 39 subjects aged from 18 to 40 years were investigated in this randomized, cross-sectional study. Accommodation measurements in photopic luminance were taken for 6 m of empty field and for optotype fixation at 2 m, 1 m and 0.5 m. At scotopic luminance, dark focus of accommodation was examined directly after darkening and after 10 min of dark adaptation. After adaptation, subjects had to visualize imaginary targets in the four distances while accommodation was measured.

Eligibility Criteria:
Inclusion Criteria:

* age 18 - 44
* visual acuity at least 0.8 (5/6)

Exclusion Criteria:

* medication with an impact on the visual system
* visual disease or disease with an impact on the visual system
* pregnancy or other hormonal variances
* drug usage
* overfatigue at the period of investigation
* mental handicap
Effect of Beetroot Juice on Reducing Hypertension in Autosomal Dominant Polycystic Kidney Disease

People with autosomal dominant polycystic kidney disease (ADPKD) develop high blood pressure and kidney disease. Previous studies have shown that a commonly occurring chemical, nitric oxide (NO), is reduced in ADPKD, and may contribute, in part, to high blood pressure in this condition. Nitrate is found in high concentrations naturally in beetroots, and increases NO. The aim of this study is to determine if beetroot juice reduces blood pressure in hypertensive people with ADPKD.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Autosomal Dominant Polycystic Kidney Disease
* Age \> 18 years old
* Estimated Glomerular Filtration Rate (eGFR) \> 30 mL/min/1.73m2
* Treatment with at least one anti-hypertensive

Exclusion Criteria:

* Inability to provide Informed Consent
* Labile, unstable, uncontrolled hypertension and/or changes in BP treatment 28 days prior to the screening visit
* Non-compliance with study procedures and/or daily BP measurements during the screening period
* Medical conditions or treatments that might interfere with the generation of NO metabolites or the primary endpoint (e.g. nitrate drugs; cigarette smoking; unwilling to stop using antiseptic mouthwash; severe, uncontrolled hypercholesterolemia; pregnancy or post-partum and lactating)
* Any serious or other medical conditions that might interfere with follow-up or stability of blood pressure (e.g. current active malignancies; uncontrolled diabetes mellitus with elevated HbA1c \> 10%)
* Dislike of taste of beetroot juice
* Allergy to beetroot
* Enrolled in other clinical trials