cyrilzakka/clinical-trials huggingface dataset:
A Study of Safety and Efficacy of MK0859 (Anacetrapib) in Japanese Patients With Dyslipidemia (0859-029)

This study will investigate the effect of MK0859 when administered alone and when in combination with atorvastatin in lowering Low Density Lipoprotein -Cholesterol (LDL-C) in Japanese patients with dyslipidemia.

This is the dose ranging study to evaluate efficacy and safety of MK-0859 in Japanese patients.

Eligible patients were assigned to 1 of 10 treatment groups (including treatment groups with or without administrative atorvastatin) for an 8-week treatment period which was followed by a 8-week reversibility period.

As an additional follow-up, the pregnancy information from women of childbearing potential who were treated with MK-0859 in this study will be collected retrospectively for a period of 4 years after the last dose of MK-0859.

Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female and between the ages of 20 and 75 years diagnosed with dyslipidemia

Exclusion Criteria:

* Patients has Coronary Heart Disease (CHD) or CHD-equivalent disease (except diabetes)
* Patients has uncontrolled diabetes
* Patient is currently participating or has participated in a study with an investigational compound within the last 3 months
Effect of Low Tidal Volume on Blood Loss During Laparoscopic Hepatectomy

To explore the effect of low tidal volume on blood loss and gas exchange during laparoscopic hepatectomy

Background \& Aims:Liver cancer is an disease that threatening human health .Laparoscopic hepatectomy is more and more widely used.It is very important to reduce the bleeding during laparoscopic hepatectomy.The investigators found that low tidal volume can effectively reduce intraoperative bleeding.The aim of this study was to explore the effect of low tidal volume on blood loss and gas exchange during laparoscopic hepatectomy

Eligibility Criteria:
Inclusion Criteria:

1. Aged from 18 to 70 years old;
2. American association of anesthesiologists(ASA) score I to III;
3. Ability to adhere to the study schedule;
4. Ability to provide informed consent and complete all study assessments;
5. Patients undergoing selective surgery of laparoscopic hepatectomy.

Exclusion Criteria:

1. The New York Heart Association classification(NYHA) III to IV;
2. Chronic obstructive pulmonary disease,respiratory failure, patients after thoracic surgery.
3. BMI\>32Kg/m2;
4. Abnormal in blood coagulation function;
5. Patients with mental disease;
6. Patients with neuromuscular disease;
7. Concurrent enrollment in another Randomized controlled trial(RCT);
8. Absence of written informed consent.
Study to Evaluate Initiation of Stalevo in Early Wearing-off

An open, non-randomised, multinational, multicentre direct switch study in levodopa-treated Parkinson's disease patients suffering from early wearing-off in Parkinson's disease. The study will consist of 2 consecutive periods: screening period and study treatment period. Duration of the study will be up to 8 weeks for each subject. The study treatment dosage will be determined by the subject's current, separately administered standard levodopa/DDCI treatment (3-4 doses per day, maximum of total daily dose of 600 mg levodopa) which will be switched to an equivalent dose of Stalevo® without changing the number of doses per day. The levodopa daily dose during Stalevo® treatment may be adjusted according to the study subject's clinical response.

See 'Brief summary'.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with idiopathic Parkinson's disease and early wearing-off symptoms treated with standard levodopa/DDCI treatment
* Age \>35 - years
* Hoehn and Yahr stage 1-3 performed during the 'ON'-stage
* At least 1 symptom identified by WOQ-9
* Dosing frequency of 3-4 doses of standard-release levodopa/DDCI (maximum total daily dose of 600 mg of levodopa)

Exclusion Criteria:

* Atypical or symptomatic Parkinson's disease
* Unpredictable OFF-periods
* Any peak-dose dyskinesia. 'OFF'-state dystonia is allowed
* Use of any rescue medications to treat symptoms of 'OFF'-state. 1 dose of soluble levodopa/DDCI is allowed.
* Concomitant treatment with non-selective monoamine oxidase (MAO) inhibitor or simultaneous use of higher than recommended doses of MAO-A and MAO-B inhibitors (selegiline 10 mg or rasagiline 1 mg allowed) or use of apomorphine.
Pressure-limited Ventilation Versus Volume-targeted Ventilation in Preterm Newborns

Aims: There is increasing evidence that volume-targeted ventilation (VTV) holds benefits for preterm infants in comparison to pressure-limited ventilation. This study aims to compare pressure-limited to VTV in preterm infants.

Hypothesis: Volume-targeted will be associated with more rapid achievement of weaning criteria compared to pressure-limited ventilation

Primary outcome: Time taken to achieve pre-specified weaning criteria.

Methods: Ventilated infants less than 34 weeks gestational age at birth were recruited within the first 24 hours of life and randomly allocated to receive either pressure-limited or VTV. Adjustments to ventilator settings were made according to the trial protocol. Infants were deemed to have met failure criteria if they required HFOV, required peak pressures of more than 26 cm of water or developed pulmonary haemorrhage. Analysis will be by intention-to-treat.


Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated
* \<34 weeks gestation
* Within first 24 hours of life

Exclusion Criteria:

* Congenital diaphragmatic hernia
* Congenital heart disease
* Oesophageal atresia
Study on the Effect and Mechanism of Aescine Sodium in the Treatment of Allergic Rhinitis

Allergic rhinitis is a common chronic non-infectious inflammatory disease of the upper respiratory tract, which affects patients' health, quality of life and work efficiency for a long time. Clinical manifestations are mainly nasal congestion, paroxysmal sneezing, clear watery nasal discharge and nasal itching, among which nasal congestion caused by nasal mucosal edema is the main manifestation of allergic rhinitis. Nasal mucosa has a rich network of arteriovenous anastomosis, and there are many large venous sinuses constitute a spongy structure, with a strong capacity for expansion and contraction, in the onset of allergic rhinitis, the volume of venous sinuses in the nasal mucosa can be rapidly changed, venous sinus expansion and filling can be induced by nasal mucosal congestion and nasal mucosal edema nasal congestion symptoms. Aescine sodium has been widely used in the clinical treatment of local tissue edema and the effect is remarkable, a large number of clinical results have proved that it has a significant anti-inflammatory, anti-edema, enhance the venous tension, improve blood circulation and anti-allergic effect, can be improved through the improvement of the vascular endothelial cell barrier, and enhance the epithelial cells close connection to improve the local edema and acute inflammation. The current treatment strategies for allergic rhinitis mainly include environmental control, medication, immunotherapy and health education, however, some patients are still unable to effectively control their symptoms in the long term after standardized treatment, and nasal congestion and runny nose cause great disturbance to the quality of their daily life. Therefore, it is urgent to investigate the mechanism of aescine sodium in relieving nasal mucosal edema in allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18-65 years).
* Patients with allergic rhinitis were diagnosed based on clinical history and positive sensitization tests (skin prick test and/or specific IgE).

Exclusion Criteria:

* Received glucocorticoids, immunomodulatory, antihistamine drugs, and other medications that may affect the study results within the last 1 month.
* Nasal diseases such as upper respiratory tract infections, chronic sinusitis with or without nasal polyps, and nasal sinus tumors.
* History of nasal sinus surgery.
* With other immune and allergic diseases.
* Patients with a combination of severe cardiac, cerebrovascular or pulmonary - diseases, aspirin triad, primary ciliary dyskinesia, immune deficiency, and coagulation disorders.
* Pregnant women.
* Smokers.
Nebivolol in Patients With Systolic Stage 2 Hypertension

The primary object of this study is to evaluate the efficacy and safety of 6 weeks of nebivolol monotherapy compared with placebo in patients with systolic stage 2 hypertension.


Eligibility Criteria:
Inclusion Criteria:

* male of female, 18 to 64 years of age at screening
* mean seated heart rate at least 60 bpm
* diagnosed systolic stage 2 hypertension
* unremarkable physical exam findings

Exclusion Criteria:

* high risk due to secondary hypertension or former stage 3 hypertension by JNC6
* concurrent conditions (reno, cardiovascular, obesity, thyroid, etc)
* currently taking medication that cannot be stopped during the course of the study
* participating other clinical trials
* member of the study center personnel
* documented drug abuse
* contra indication to beta blocker
* abnormal lab finding
* poor compliance
* other conditions judged by investigator that is not suitable for the study
Effect of the Dietary Supplement Taxifolin Aqua on the Recovery Period After COVID-19 Pneumonia

Objective of the study is to evaluate the effect of Taxifolin Aqua therapy on the indicators of respiratory function, the state of the arterial wall, the contractile function of the myocardium, as well as to assess the effect of Taxifolin Aqua therapy on markers of biological age, quality of patients life.

The study will include 100 patients who had covid pneumonia 3 months ago. If the inclusion / exclusion criteria are met, the patient is asked to sign an informed consent to participate in the study. Consenting patients are randomized to an intervention group or a control group. The control group (n = 50) will receive standard therapy, patients from the intervention group (n = 50) will be prescribed Taxifolin Aqua 30 mg per day in addition to standard therapy. Patients will be randomized to the control and main group using random number spreadsheets, assuming that the control and main groups will be homogeneous in the main demographic and clinical parameters. Patient monitoring will be carried out within 2 months from the date of inclusion. A follow-up visit is scheduled in 2 months. During the study, the patient will be regularly monitored for tolerance and safety of therapy with Taxifolin Aqua.

Eligibility Criteria:
Inclusion Criteria:

Patients of both sexes who had covid pneumonia 3 months ago and signed an informed consent and aged 18+.

Exclusion Criteria:

Standard contraindications to Taxifolin Aqua use.
Integrated Care for Cancer Patients; Developing, Implementing and Testing a Programme to Improve Integrated Care

The purpose of this study is to compose, implement and evaluate a programme to improve the quality of integrated care for patients with cancer.

Literature will be searched for components of integrated care programmes. On the basis of evidence based multi-disciplinary guidelines and literature on integrated care programmes, a set of indicators will be composed. This set will be measured in 6 hospitals on patients with non-small-cell-lung cancer. In two hospitals, an integrated care programme will be implemented and effects on processes and outcomes of care will be measured.


Eligibility Criteria:
Inclusion Criteria:

* Each new patient that visits the lung specialist in 6 hospitals in the east part of Holland, in the period from September 2004 till March 2005

Exclusion Criteria:

* Mortality
Evaluation of Performance of An Aspergillus PCR in Tissue and Pleural Effusion Samples of Immunocompromised Patients

Although being a frequent and lethal complication in patients (pts) with hematologic malignancies, diagnosing invasive aspergillosis (IA) still remains a difficult issue as culture-based methods show low sensitivity especially under the current clinical practice of antifungal prophylaxis or rapid antifungal therapy. In certain clinical settings, performing biopsies for identification of the underlying infectious organism becomes important. However, as culture-based methods only yield results in a minority of patients, using non-culture-based methods like Aspergillus specific polymerase chain reaction (PCR) for detection of IA directly in clinical specimens is becoming increasingly important and might help to characterize the causative pathogen.

Therefore the performance of an established Aspergillus-specific nested PCR in biopsies, re-section material or pleural effusions is evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Immunocompromised individuals with suspicion of harbouring an invasive fungal infection
* Definition by 2008 EORTC/MSG Criteria (de Pauw CID 2008)

Exclusion Criteria:

* none
A Single-Center, Clinical Study to Evaluate the Safety of a New Personal Lubricant in Healthy Female Subjects

To evaluate the safety of a new personal lubricant when used at least four times weekly for two weeks (including at least twice weekly during sexual intercourse for subjects with monogamous male partners), in a population consisting of healthy females.


Eligibility Criteria:
Inclusion Criteria:

* no participation in a similar study 2-weeks prior
* may be post-menopausal or have had a hysterectomy
* if sexually active, and of child bearing potential, subjects using adequate non-barrier method of birth control
* free from any vaginal disorders
* sexually active and monogamous, heterosexual relationship, and whose male partner is willing and able to give informed consent and agrees to engage in sexual intercourse at least twice each week during the two-week study or is not sexually active
* personal lubricant user and agrees to replace her usual personal lubricant with the investigational product
* can start regardless of where they are in their cycles
* agrees to use the provided investigational product at least four times weekly over the two week study period
* exhibits no clinically significant evidence of vulvar or vaginal irritation, as determined by a study doctor, and no reports of sensory irritation at the baseline exam
* willing to refrain from introducing any new vaginal products, or using vaginal medications or local contraceptives during study
* agrees to refrain from douching or using any medications, powder, lotions or personal care products in the vulvar or perianal area
* willing to use a urine pregnancy test provided to them at baseline and on third visit
* standard medical history form on file
* signed informed consent
* completed HIPAA
* dependable and able to follow directions as outlined
* receives a score of 0 or 0.5 for erythema and edema: and 0 for sensorial irritation (burning, stinging, itching and dryness) during the first examination.

Exclusion Criteria:

* pregnant, nursing or planning a pregnancy
* currently using or has used within two weeks prior to the study initiation, any systemic or topical corticosteroids, vasoconstrictors, antibiotics, anti-inflammatories or antihistamines
* known allergies to vaginal or any cosmetic products
* reports history of recurrent bladder, vaginal infections or incontinence
* exhibits or reports gynecologic abnormalities or has had vaginitis within 60 days prior to study initiation
* uses a vaginal ring, diaphram or cervical/vault caps, condoms, or condoms with spermicide as a means of contraception
* participated in a study involving the vaginal area or in an investigational systemic drug study within two weeks of study initiation
* receives a score higher than 0/5 for erythema, edema or \>0 for burning, stinging, or itching, during first examination or shows any other sign of mucosal irregularities
Study to Develop Head Stabilizer for Use During Brain Radiation Therapy

The purpose of this study is to begin to develop a device to stabilize the head during stereotactic radiosurgery (SRS). SRS is a therapy for brain disorders and cancers that uses a precise dose of radiation to treat a disease, and is different from whole brain radiation. This study aims to stabilize patient head motions during radiation therapy through the use of a special experimental head holder. The investigators would like to first see how the experimental device works in whole brain radiation.


Eligibility Criteria:
Adults undergoing whole brain radiation cancer treatment at the University of Chicago Medicine.
Dual Trigger in the Final Oocyte Maturation in Poor Ovarian Responders

This is a randomized controlled clinical trial to investigate the effect of dual trigger (hCG and GnRH agonist) on the final oocyte maturation compared to the standard hCG trigger in patients with poor ovarian reserve seeking IVF/ICSI treatment.

Women with POR (Bologna criteria) manifest a very low follicular response to controlled ovarian stimulation irrespective of the stimulation protocol utilized. Dual triggering of oocyte maturation was shown to improve follicle collection yield and oocyte maturation in women with predicted normal ovarian response. These benefits have been attributed to the GnRHa-induced FSH surge believed to promote oocyte nuclear maturation and cumulus expansion. The aim of the study is to show whether the co-administration of a GnRH agonist and hCG for final oocyte maturation improve oocyte collection and maturation rate

Eligibility Criteria:
Inclusion Criteria:

* Normal uterine cavity (as assessed by hysteroscopy or HSG).
* Normal hormonal investigation: TSH, PRL.
* Low ovarian reserve patients (AMH\<1.5ng/ml, AFC of 7 or less, 5 oocytes or less retrieved in a previous cycle)

Exclusion Criteria:

* Abnormal uterine cavity (Hysteroscopy or HSG)
* Evidence of untreated endocrine disorders (abnormal TSH, prolactin, testosterone and androstenedione concentrations)
Comparison of the Efficacy and Safety of Tiropramide and Octylonium in the Treatment of Irritable Bowel Syndrome

The purpose of this study was to compare the Efficacy and Safety of Tiropramide HCl and Octylonium bromide in the Treatment of Irritable Bowel Syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (aged 20-75 years)
2. Patients who had been suffered from IBS as defined by Rome III criteria
3. Patients who had abdominal pain at least 2 days/week, during the run-in period of 2 weeks

Exclusion Criteria:

1. Patients with known intolerance to tiropramide or octylonium
2. Patients with uncontrolled diabetes, uncontrolled hypertension or thyroid dysfunction
3. Patients who had the history of cancer \[However, patients with cancer other than gastrointerstinal cancer, who have not recurr within 5 years after treatment were possible for enrollment\]
4. Patients with hepatic or renal dysfunction
5. Patients with lactose intorelance
Efficacy and Safety of Repeated Intraarticular Injections of Hyaluronic Acid in Patients With OA of the Knee

The main objective is the long-term comparison (3 years and 4 months) of the efficacy and safety of repeated intra-articular administration of hyaluronic acid in the treatment of osteoarthritis of the knee.

To evaluate the efficacy and safety of repeated injections of hyaluronic acid compared with placebo over a period of 40 months.

Eligibility Criteria:
Inclusion Criteria:

* Patient \> 45 years of age
* Out-patient diagnosed with primary osteoarthritis of the femorotibial medial joint of the knee with clinical and radiological (Kellgren grade II-III) ACR diagnosis
* Joint Space Width (JSW) \> 2mm
* Overall pain greater or equal to 55mm (VAS - Visual Analogue Scale 100mm) recorded in the knee,by the patient at any time during the week prior to the evaluation

Exclusion Criteria:

* Overweight patients (body mass index \> 32).
* Pregnant and lactating women. Women of child-bearinge age not using effective contraception
* Patients who have received intra-articular hyaluronic acid within the previous year and/or intra-articular steroids or articular lavage in the chosen knee,within the previous 3 months prior to their inclusion in the study.
* AINE administration within the 14 days prior to their inclusion in the study.
* Administration of glucosamine sulphate, chondroitin sulphate and diacerein within the 3 months prior to their inclusion in the study.
* Immunocompromised patients or patients receiving systemic immunosuppressive therapy.
* Patients with known sensitivity to HA, parcetamol or AINEs permitted as rescue medication.
* Patients who have received any investigational drug within 30 days prior to visit 1, or who are scheduled for the administration of an investigational drug other than the protocol product during this study.
* Patients with severely impaired central nervous system.
* Patients with coagulation alterations, despite receiving treatment.
* Patients with secondary osteoarthritis of the knee
* Patients having previously received surgery, including arthroscopy
* Patients with articular inflammatory disease
Intervention Effects on Health Promoting Behaviors and Factors Influencing Long-Term Behavior Change

This study aims to compare the 8-week virtual Healthy YOU Program with a standard care intervention that sends weekly nutrition and healthy living tips via email. It will evaluate short- and long-term changes in health behaviors, such as diet, physical activity, biomarkers, and body composition. The study also seeks to identify factors that help participants make lasting health changes and explore how lifestyle interventions can improve overall health. Findings may guide future programs and support non-weight-focused approaches to chronic disease management and healthcare policy.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-65
* BMI between 25.00 and 40.00

Exclusion Criteria:

* Pregnancy or lactation
* Existing or previous eating disorders
* Use of a medically prescribed diet
* Weight loss or gain of 3 kg or more in the past 3 months
* Use of medications or supplements for weight or chronic disease management (withing the last 3 months)