cyrilzakka/clinical-trials huggingface dataset:
Maternal Serum Stathmin-1 Levels in Preeclampsia

This study investigates maternal serum Stathmin-1 (STMN-1) levels in pregnancies complicated by preeclampsia and severe preeclampsia, compared to healthy pregnancies. The aim is to explore potential differences in STMN-1 levels among these groups to better understand its role in preeclampsia pathophysiology. Maternal serum STMN-1 levels will be measured between 32-34 weeks of gestation, and patients will be monitored until delivery to assess whether they develop preeclampsia or severe preeclampsia.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Preeclampsia: Defined by New-onset hypertension (Systolic Blood Pressure ≥140 mmHg and/or Diastolic Blood Pressure ≥90 mmHg) after 20 weeks of gestation, with or without proteinuria.
* Clinical diagnosis of Severe Preeclampsia: Defined by criteria such as severe hypertension (systolic BP ≥160 mmHg or diastolic BP ≥110 mmHg), organ dysfunction (renal insufficiency, liver involvement, neurological complications), thrombocytopenia, pulmonary edema, or fetal growth restriction.
* Control Group: Healthy pregnancies without preeclampsia

Exclusion Criteria:

* Multiple Pregnancies
* Pregestational Diabetes
* Chronic Hypertension
* Systemic Diseases (Chronic kidney disease, autoimmune diseases)
* Fetal Anomalies
* Premature Rupture of Membranes
Detection and/or Evaluation of Dense Breast Abnormalities Using Tomosynthesis and Digital Mammography

The purpose of this study is to compare 3D mammography with digital mammography in women with dense breasts for the detection and evaluation of masses and/or breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Females 30 years of age or older.
* Dense Breasts.
* Has undergone clinical two view mammogram and diagnostic breast imaging evaluation.
* Suspicious or palpable mass and scheduled for biopsy.

Exclusion Criteria:

* Pregnant or lactating women.
* Prior personal history of breast cancer.
* Prior breast augmentation with implants or silicon injection. male patients.
* No two view mammogram as part of breast imaging evaluation.
* Breast density of almost entirely fatty/scattered fibroglandular densities.
An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Patients With Generalized Anxiety Disorder

The purpose of the study is to evaluate the efficacy and safety of SR58611A in patients with Generalized Anxiety Disorder. The primary objective is to evaluate the efficacy of a 700 mg dose of SR58611A compared to placebo in patients with generalized anxiety disorder (GAD).The secondary objectives are to evaluate the efficacy of SR58611A on disability and quality of life in patients with GAD and to evaluate safety of SR58611A.

The study is a multicenter, multicountry, randomized, parallel-group, double blind, placebo and paroxetine-controlled study consisting of three segments (A, B, and C). Segment A is a 1-week, placebo, single-blind period and Segment B is an 8-week, double blind period. All randomized patients must complete a post-study visit 1 week after intake of the last dose of study medication.

Eligibility Criteria:
Inclusion Criteria:

* Out-patients, 18 to 65 years of age.
* Patients suffering from generalized anxiety disorder (GAD) as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) plus GAD Module.
* With a total score on the 14-item Hamilton Anxiety Rating Scale (HAM-A) ³ 20.
* Having given voluntarily their written informed consent to participate in the study.
* Able to comply with the protocol and follow written and verbal instructions.
* For inclusion into Segment B of the study, patients must fulfill the following criteria:
* All Segment A inclusion criteria.
* Completion of a minimum of 3 and a maximum of 9 days of treatment in Segment A.
* Not "placebo responders" (i.e., improvement £ 20 % on HAM-A total score between V1 and V2)

Exclusion Criteria:

* Patients with a diagnosis of Major Depressive Disorder as defined by DSM-IV-TR within 6 months of study entry.
* Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) total score of 18 or higher at screening or baseline visits.
* Patients having a moderate to high current risk for suicide.
* Patients with other current anxiety disorder assessed with the MINI: agoraphobia, social phobia, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, acute stress disorder.
* Patients with a lifetime history according to the MINI of: bipolar disorders, psychotic disorders, antisocial personality disorder.
* Patients with severe or unstable concomitant medical conditions according to the Investigator's judgment.
* Females who are pregnant or lactating.
* Female patients of childbearing potential must use an effective method of birth control during the entire study period.
* Patients with positive test for any illicit drug included in the urine drug screen.
* Participation in a clinical trial of an experimental therapy within 3 months prior to screening
Ultrapure Water System for Hemodialysis Therapy

We wish to compare the effect of very clean water used for dialysis therapy (i.e ultrapure water) in comparison with the use of conventional water which are used in most dialysis units worldwide. To the best of our knowledge prospective data in that field is sparse.

In observational studies, the use of very pure dialysis solution has been suggested to reduce the plasma level of CRP, IL-6 ; to improve the response to anemia to erythropoietin therapy ; to promote better nutrition as evidenced by increase in plasma albumin value , estimated dry body weight, midarm muscle circumference and urea-nitrogen appearance rate; to reduce plasma level of β2-microglobulin and pentosidine ; to dely carpal tunnel syndrome ; to slow the loss of residual renal function; and to lower cardiovascular morbidity.The aim of this study is to prospectively evaluate the effect of dialysis performed with ultra-pure water (UPW)in comparison with dialysis with the use of conventional water system. Patients enrolled into this study will be evaluated at initial period of one month treated with conventional water system (-30 to 0 days). Then water system will be switched to ultra-pure water system with the use of filter added to the dialysis machine (Gambro). After switching to UPW system the patients will be followed for a period of one year (days 0-365). Primary end point will be change in CRP. Additional parameters: Blood pressure, adverse events during dialysis, hemoglobin levels and white-blood cell counts.

Eligibility Criteria:
Inclusion Criteria:

1. chronic hemodialysis therapy thrice weekly \> 3 months of therapy
2. Signed an informed consent -

Exclusion Criteria:

1. Enrolled to other study
2. Ongoing infection -
Comparing the Rate of Insufficient Cells for Diagnosis Between Surepath® and Conventional Smear in Women After Radiation Therapy for Cervical Cancer

Background/Purpose: This is a large scale, multicenter randomized clinical trial to assess the feasibility of using SurePath® in cervical cancer patients after radiation therapy by comparing the incidence of unsatisfactory smear and the accuracy of detecting cervicovaginal lesions between the SurePath® and the conventional smear.

Patients and Methods: The investigators will invite all women who had received radiotherapy for cervical cancer in the investigators outpatient clinics. All enrolled cases will ask to receive randomly the SurePath® or the conventional smear.

Expected Results: The investigators will get the incidence of unsatisfactory smear and the accuracy of detecting cervicovaginal lesions between the SurePath® and the conventional smear in patients who underwent radiotherapy.

Adequate specimen (specimen adequacy) is cervical or vaginal cytology single most important quality factors. 2001 Pap Bethesda System classification maintain its previous version, the Pap specimen is divided into satisfactory assessment and unsatisfactory evaluation two kinds; meet "satisfactory assessments "specimen standard, conventional Pap (conventional smear) requires at least 8,000-12,000-readable squamous cells, and liquid-based Pap (liquid-based smear) you need at least 5,000-readable squamous cell .

For squamous cell samples were determined to be adequate, yet to record their specimens have intrauterine neck or squamous transitional zone (transformation zone) border zone cells exist; quality indicators "Cell interpretation in part by inflammation or blood masking noise "of the specimen, if it can not be sentenced to 50-75% of epithelial cells can still be classified as read" satisfied "with the specimen, while more than 75% of the epithelial cells are obscured interference specimen is classified in the" unsatisfactory "specimen.

Eligibility Criteria:
Inclusion Criteria:

1. All women who had received radiotherapy for cervical cancer in our outpatient clinics.
2. Prior to joining test subjects for 90 days or more earlier had received a complete pelvic radiation therapy, including treatment of the cervix or vagina.
3. Subjects with radiation therapy (including combined chemical and radiation therapy or postoperative adjuvant \[chemical\] radiation therapy) for their first treatment.

Exclusion Criteria:

1. recurrence of cervical cancer
2. hormone treatment within 90 days
3. vaginal vault or cervix topical treatment within 90 days.
4. Subjects had or now have other malignancies
Comparison of Bone Morphogenetic Protein-4 (BMP-4) and 7 Levels Between Control and Polycystic Ovarian Syndrome (PCOS) Patients.

The investigators aim to compare the levels of bone morphogenetic protein-4 and -7 (BMP-4 and 7) in blood, follicular fluid and ovarian organ culture supernatant obtained from healthy subjects and polycystic ovarian syndrome (PCOS) patients.

Female patients at ages 20-35 diagnosed with polycystic ovarian syndrome and age-matched healthy control subjects will be enrolled in this study.

Blood samples will be obtained at early follicular phase during doctor's visit from PCOS patients and control subjects.If the patient is amenorrheic at the time of visit, both random blood samples and another sample at early follicular phase after induction of withdrawal bleeding with progesterone.

Follicular fluids will be retrieved during oocyte pick-up procedure in patients undergoing assisted reproduction for PCOS and control IVF patients whose infertility is not PCO related.

Samples from ovaries will be collected at operation from PCOS patients and control subjects if they already undergo any gynecologic laparotomi operations.

Collected samples will be cultured for 7 days and BMP-4 and -7 levels will be measured in the culture fluid of the samples using ELISA method.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects and PCOS patients at ages 20-35 will be recruited for the study.

Exclusion Criteria:

* Those with any metabolic or endocrine problems other than PCOS will be excluded from the study.
A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment

This 2-arm study was designed to assess the long-term safety and tolerability of intravenous (IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received Bonviva either 2 mg IV every 2 months, or 3 mg IV every 3 months. Patients also received daily supplementation with vitamin D and calcium. The anticipated time on study treatment was 2+ years, and the target sample size was 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* Successful completion of Bonviva study BM16550 (NCT00048074), with at least 75% compliance
* Ambulatory

Exclusion Criteria:

* Patients who completed the Bonviva study BM16550 (NCT00048074) \>3 months before the planned start date for this study
* Malignant disease diagnosed since inclusion into previous study
* Treatment with drugs affecting bone metabolism since inclusion into previous study
Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive Breast Cancer

This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel versus placebo and trastuzumab plus docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* female patients, 18 years ≤ age ≤ 75 years；
* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
* Histologically confirmed invasive breast cancer（early stage or locally advanced）:Primary tumour greater than 2 cm diameter
* HER2 positive (HER2+++ by IHC or FISH+)
* Known hormone receptor status.
* Cardiovascular:Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO
* Signed informed consent form (ICF)

Exclusion Criteria:

* metastatic disease (Stage IV) or inflammatory breast cancer
* Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
* clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
* Unable or unwilling to swallow tablets.
Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery

The goal of this clinical trial is to learn if the administration of tranexamic acid can reduce the necessity of blood transfusions in adult patients undergoing major abdominal surgery. . It will also inform about safety of tranexamic acid in this setting.

The main question it aims to answer is: Does tranexamic acid lower the probability of receiving at least one blood transfusion during or after surgery?

Participants will compare tranexamic acid o a placebo (a look-alike substance that contains no drug) to see if tranexamic acid works to reduce the necessity of a blood transfusion.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or above
2. Planned elective esophagectomy, gastrectomy, colectomy, rectal resection, pancreatic resection, or hepatectomy
3. Adequate renal function with serum creatinine \<250 µmol/L (2.82 mg/dL)
4. Written informed consent obtained before randomization
5. Negative pregnancy test for women of childbearing potential within 14 days of commencing study treatment. Females of reproductive potential must agree to practice highly effective contraceptive measures during the study. These comprise measures with a failure rate of \<1% per year when used consistently and correctly, such as intravaginal and transdermal combined (oestrogen and progestogen containing) hormonal contraception, injectable and implantable progestogen-only hormonal contraception, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion; vasectomised partner, sexual abstinence (defined as refraining from heterosexual intercourse during the entire study period).

Exclusion Criteria:

1. Severe anaemia, defined as a haemoglobin concentration \<8 g/dL (\<5 mmol/L) or anaemia with haemoglobin concentration ≥8 to \<10 g/dL (≥5,0 to \<6,2 mmol/l) and one or several of the following symptoms suggesting hypoxemia:

   * Clinical signs of tachycardia, e.g., resting heart rate \>100 beats/minute, palpitation etc.
   * Clinical signs of hypotension, e.g., resting systolic blood pressure \<100 mmHg, orthostatic dysregulation etc.
   * Clinical signs of dyspnea, e.g., speech dyspnea, resting respiratory rate \>20 breaths/min.
2. Thrombocytopenia with platelets \<60 x 109 /L
3. Confirmed bleeding disorder with the need for specific preventive perioperative treatment (e.g., factor deficiency with the need of perioperative substitution)
4. A priori refusal of blood transfusions
5. Confirmed thrombophilia with a pertinent need for perioperative anticoagulation
6. Allergy / hypersensitivity to tranexamic acid
7. Recent (\<30 days) thromboembolic event
8. History of medically confirmed convulsions
9. In female subjects: pregnancy or lactation
Telecommunications System in Sleep Apnea

This study is investigating the effects of a telecommunications system designed to improve patient adherence with prescribed positive airway pressure (CPAP).

Background/Rationale:

Obstructive sleep apnea syndrome (OSAS) is an important chronic disease of adults, affecting an estimated 4% of men and 2% of women in the United States. Nasal continuous positive airway pressure (CPAP) has been demonstrated to ameliorate the symptoms and neurobehavioral consequences of OSAS. Unfortunately, patient adherence with prescribed CPAP is low, diminishing the benefits obtained from this expensive therapy. Nurse-administered patient education and monitoring of CPAP use through home visits has been shown to be effective in significantly improving CPAP adherence. Given the logistic complexity of delivering this service and its costs, it is unlikely to be disseminated widely into clinical practice. An alternative, using advanced telecommunications technology to deliver similar adherence improvement services, is proposed for study.

Objective(s):

Use of telecommunications systems with other important health-related behaviors such as medication-taking, diet, and exercise have demonstrated significant improvements in therapy adherence.

Methods:

This research project represents a randomized controlled trial of a Telephone-Linked Communications (TLC) system designed to improve CPAP adherence (TLC-CPAP). The study will enroll adults with OSAS who are being started on nasal CPAP therapy. Subjects will be randomized to TLC-CPAP or an attention placebo control group. The effect of TLC on CPAP use and on disease-specific quality of life (QOL), OSAS-related symptoms, depression, and vigilance over a 12-month interval will be assessed.

The intervention and control groups will be compared to assess differences in potential confounders including age, sex, OSAS severity, CPAP pressure level, comorbid illness, physician specialty status, BMI, socioeconomic status, and marital status. Each of the outcome variables (all of which are continuous variables) will be compared between intervention and control groups using multivariate analyses to adjust for any potential confounders that differ between groups. Multivariate models will include appropriate tests of interactions. All analyses will be performed using an intent-to-treat approach.

Status:

Completed

Impact:

This Telephone-Linked Communications (TLC) technology offers an effective, low-cost, and easy-to-use means of providing disease-specific education, monitoring, and counseling to improve adherence with therapy.

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of obstructive sleep apnea syndrome plus polysomnography demonstrating greater than 10 apneas plus hypopneas per hour of sleep
* Age 18-80 years
* Ability to use a telephone without assistance

Exclusion Criteria:

N/A
The Ideal Local Anesthetic for Intraperitoneal Gallbladder Bed Infiltration Following Laparoscopic Cholecystectomy

To control pain after surgery for removal of gallbladder, local anesthetic agent can be sprayed on the liver bed from where the gallbladder is removed. This study was conducted to identify the ideal local anesthetic agent for this purpose.

Laparoscopic cholecystectomy is the gold standard operation for symptomatic cholelithiasis; however, pain remains a major factor increasing morbidity and length of hospital stay. Infiltration of gallbladder bed with local anesthetic has been shown to improve post-operative pain after laparoscopic cholecystectomy, although, it is unclear which local anesthetic provides superior pain relief. Patients undergoing laparoscopic cholecystectomies were randomized into 3 groups of 30 patients each depending on the local anesthetic instilled in the gallbladder bed; lignocaine (Group A), bupivacaine (Group B), or a combination of lignocaine and bupivacaine (Group C). Pain was measured using visual analogue score at 2-, 6-, 12- and 24-hours following surgery

Eligibility Criteria:
Inclusion Criteria:

* elective/emergency laparoscopic cholecystectomy
* ASA grade I/II
* Ages 18-75 years

Exclusion Criteria:

* patients on chronic analgesics
* pts receiving analgesics 24 hours prior to surgery
* intraoperative bile spillage or drain placement
* CBD exploration or T-tube insertion
* BMI \&gt; 40 kg/m2
* pts allergic to, or otherwise not able to receive medications being tested
Effects of Sulforaphane on Cognitive Function in Patients With Frontal Brain Damage

High rates of patients with frontal brain damage show serious cognitive functional deficits, which negatively impact their quality of life and are linked with poor clinical outcomes. Sulforaphane has shown significant antioxidant and cellular protective effects in animal models associated with oxidative stress, such as focal cerebral ischemia, brain inflammation, and intracranial hemorrhage. Preclinical research has shown that sulforaphane can significantly improve spatial localization and working memory impairment after brain damage. The primary aim of this clinical trial is to assess the efficacy of sulforaphane for improving cognitive function in patients with frontal brain damage.

90 patients aged 18-65 years, of both genders, who have incurred cognitive deficits after frontal brain damage will be recruited in the neurosurgery department in Xiangya hospital. All focal lesions were confined to the frontal brain, which is verified by CT or MRI. Cognitive deficits will be diagnosed using the Chinese version of the Montreal Cognitive Assessment (MoCA-C). All eligible recruited patients will be randomly divided into two groups in a 2:1 ratio. Participants will receive a battery of cognitive tests at baseline and again after 4 and 12 weeks to determine the effect of sulforaphane on cognition. T1-weighted brain magnetic resonance images and resting-state functional MRI will be carried out using 3 Tesla (3T) brain MRI at these timepoints. Brain magnetic resonance spectrum will be applied to detect MRI markers of brain metabolites and gut microbiota will also be assessed over this period.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Focal lesions were confined to the frontal brain, which is verified by CT or MRI
* Clinical diagnosis of Cognitive deficits using the Chinese version of the Montreal Cognitive Assessment (MoCA-C) with scores \< 26 will be assessed as having cognitive deficits (\<25 for patients educated \<12 years)
* be adherent to the continued sulforaphane treatment medication

Exclusion Criteria:

* Previous history of cognitive impairment
* Brain MRI indicating damage was not restricted to the frontal lobe.
* Inability to cooperate with cognitive testing for disturbance of consciousness or mental disorder
* Pregnancy or maternal lactation
* Life expectancy \< 3 months
* CO poisoning, autoimmune encephalitis, intracranial infection, or other types of diffuse intracranial disease.
* plan to receive radiotherapy during the trial period
* Laboratory examination showing liver and kidney insufficiency or other severe complications; the presence of diseases which may interfere with the results of the evaluation
* Involvement in other trials 1 month prior to the start of the trial or during the trial period