cyrilzakka/clinical-trials huggingface dataset:
PK/PD Properties and Safety of Remazolam Besylate for Injection in ICU Patients With Impaired Renal Function

Pharmacokinetic/pharmacodynamic profiles of remazolam besylate were compared in patients with impaired and normal renal function in the ICU, and safety was assessed by recording hemodynamic parameters and adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥18 and ≤ 30 kg/m2
* Being Intubated and mechanically ventilated ≤48 hours before enrollment and expected to be on a ventilator for at least 6 hours
* Requirement for light to moderate sedation (a Richmond agitation-sedation scale score of -2 to 1) Patients with impaired renal function were defined as having a glomerular filtration rate of 30 to 89 ml/min/1.73m2. Patients with normal renal function were defined as having a glomerular filtration rate of 90 to 120 ml/min/1.73m2

Exclusion Criteria:

* Refusal to be included
* Allergy or unsuitability to any composition of study drugs or remifentanil
* Living expectancy less than 48 hours
* Myasthenia gravis
* Status asthmaticus
* Abdominal compartment syndrome
* Serious hepatic dysfunction (CTP 10-15);
* Chronic kidney disease with glomerular filtration rate (GFR) \< 29 ml/ min/1.73m2
* Mean blood pressure less than 65 mm Hg or the need for a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain Mean blood pressure ≥ 65 mm Hg
* Possible requirement for surgery or bedside tracheostomy in 24 hours
* Possible requirement for renal replacement therapy in 24 hours
* Acute severe neurological disorder and any other condition interfering with sedation assessment
* Abuse of controlled substances or alcohol
* Pregnancy or lactation
Oncoplastic Breast-conserving Surgery in Non-metastatic Breast Cancer Patients

Breast-conserving surgery (BCS) is the traditional surgical treatment for early-stage breast cancer patients. There are evidences indicating that oncoplastic-BCS (displacement technique) could improve cosmetic outcomes and/or quality of life, and has similar oncological safety as traditional BCS does. However, there are no prospective trial comparing oncoplastic-BCS vs. traditional BCS in terms of cosmetic outcomes and oncological safety. In this study, the investigators are going to address this issue by assigning patients into traditional and oncoplastic-BCS group, based on their preference.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed
* ECOG\<=2
* Non-metastatic breast cancer patients with unilateral breast cancer confirmed by pathology.
* Operable or operable after neoadjuvant chemotherapy.
* Extensive, diffuse micro-calcifications on mammography before surgery
* No history of breast surgery or breast radiation therapy before.
* Able to follow the standard of care in adjuvant chemotherapy, radiation therapy, endocrine therapy and targeted therapy after surgery.

Exclusion Criteria:

* Multifocal/multicentric diseases noticed before surgery.
* Inflammatory breast cancer or invasive micro-papillary carcinoma of the breast confirmed by pathology before surgery.
* Tumor size \> 5 cm revealed by physical examination, Ultrasound or mammography before surgery.
* Tumor size/breast size ratio \>0.5 revealed by by physical examination, Ultrasound or mammography before surgery.
* Have other malignant tumors.
* Have severe co-morbidities that compromise the patients' compliance to our protocol, or endanger the patients.
* Participated in other clinical trials.
* Pathologically confirmed metastatic breast cancer, bilateral breast cancer or DCIS patients.
* Patients with any organ failure.
* Pregnancy women
* Patients who desire to have mastectomy before surgery.
A Study of ASP1941 in Participants With Type 2 Diabetes Mellitus

The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP1941 in male and female patients with type 2 diabetes mellitus


Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of type 2 diabetes mellitus
* Fasting serum C-peptide level \> 0.6 ng/mL
* HbA1c between 7.0 and 10.0%
* Body Mass Index between 20 and 45 kg/m2

Exclusion Criteria:

* Serum creatinine \> upper limit of normal
* Proteinuria (albumin/creatinine ratio \> 300 mg/g)
* Dysuria and/or urinary tract infection
* Significant renal, hepatic or cardiovascular diseases
* Ketosis
* Hypertension
* Severe gastrointestinal diseases
Epidural Analgesia (EDA) Versus Patient Controlled Analgesia (PCA) in Laparoscopic Colon Surgery

The purpose of this study is to determine whether a epidural analgesia versus patient controlled analgesia reduces the medical recovery in patients undergoing elective laparoscopic colon surgery.

Allocation by individual random number generated by a computer program to either EDA or PCA for 48h after laparoscopic colonic surgery.

Short, both groups are treated according to a recent Fast track protocol. Group A will preoperatively receive a mid thoracic EDA (th 8-9; naropine 0,1%) while group B will receive a PCA (morphine) postoperatively. Both EDA and PCA are removed the afternoon at day 2. Patients with a non-functioning EDA within the first 24h will be crossed over to the PCA group.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted for elective laparoscopic colonic surgery

Exclusion Criteria:

* Age \< 18y
* No informed consent
* Emergency situation
* Contraindication for EDA (according to local Anesthesia guidelines)
Evidence-Based Approach to Empower Asian American Women in Cervical Cancer Screening

This is a randomized trial to evaluate the effects of a community-based intervention on increasing cervical cancer screening rates in underserved Asian American (Korean, Vietnamese, and Chinese) women. All women will receive an educational program and navigation assistance. Women in the intervention condition will also receive a self-sampling kit for self-collection of a cervical sample for HPV testing. The investigators will evaluate whether the inclusion of a self-sampling kit increases the proportion of Asian American women who participate in cervical cancer screening.

Aim 1: Compare rates of providing a self-collected sample vs. obtaining clinic-based screening among 1100 Asian American women. It is hypothesized that the proportion of women in the HPV self-sampling program who provide a self-collected sample will be higher than the proportion of women in the clinic-based program who obtain clinic-based screening.

Aim 2: Examine mediators of participation. The investigators will examine both individual- and social/environmental-level factors associated with participation across both programs. It is hypothesized that higher levels of perceived self-efficacy, lower levels of embarrassment, and fewer barriers will be associated with higher rates of participation in both conditions. Further, it is hypothesized that women in the HPV self-sampling program will report greater self-efficacy, less embarrassment, and fewer barriers compared to women in the clinic-based program.

Aim 3: Assess the relative cost-effectiveness of HPV self-sampling vs. clinic-based screening. The investigators will conduct an incremental cost-effectiveness analysis from a societal perspective incorporating trial-based direct medical and participant-borne costs associated with HPV self-sampling vs. clinic-based screening. It is hypothesized that the self-sampling program will be less costly to implement and achieve a higher participation rate.

Eligibility Criteria:
Inclusion Criteria:

* Women who are of Asian race and self-identify as Korean, Vietnamese, or Chinese
* are 30-65 years of age
* are overdue for cervical cancer screening (e.g., no cytology-based screening within the past 3 years; no hrHPV testing either alone or in combination with cytology in the past 5 years)

Exclusion Criteria:

* have a prior diagnosis of cervical cancer or cervical abnormality (e.g., dysplasia)
* had a hysterectomy with removal of the cervix
* have a compromised immune system (e.g., known HIV)
* unable to provide informed consent
Impact of Rutin and Vitamin C Combination on Oxidative Stress, Insulin Sensitivity and Lipid Profile in Type 2 Diabetic Patients

The objective of this study is to investigate the effect ofRutin and Vitamin C combination in comparison with vitamin C alone on the oxidative and antioxidative status , insulin resistance and lipid profile in type 2 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* • Patients' age 35 years or older having type 2 diabetes mellitus.

  * Patients taking oral diabetic medications (Sulfonylurea) not taking Insulin.
  * Able to understand and willing to sign a written informed consent document

Exclusion Criteria:

* • Pregnant and breast feeding females

  • use of vitamin supplements containing vitamin C or other antioxidants.
* patients with renal or hepatic failure.
* patients taking insulin as antidiabetic treatment
Efficacy of rTMS (Repetitive Transcranial Magnetic Stimulation) on Patients With Somatoform Pain Disorder

Chronic somatoform pain is common in psychiatric patients. Chronic somatoform pain causes significant distress and disrupts social functioning. Moreover, chronic somatoform pain often does not sufficiently respond to medication.

Chronic somatoform pain is associated with medial pain system. The medial pain system is comprised of structures engaged in affect and motivation, such as medial thalamus and limbic structures. The medial pain system gets inhibitory control from motor cortex. Functional neuroimaging studies indicate that chronic somatoform pain is associated with hypoactivity of motor cortex, defective inhibitory process, and hyperactivity of medial pain system.

Repetitive Transcranial Magnetic Stimulation (rTMS) is a safe and non-invasive tool to modulate neurophysiologic activity of the focal brain. Therefore, pain relief by rTMS can be obtained from motor cortex stimulation, restoration of defective inhibitory process, and deactivation of medial pain system. Studies have shown that motor cortex stimulation using rTMS can relieve pain in patients with neuropathic pain. However, to our knowledge, there is no rTMS study on chronic somatoform pain in psychiatric patients. The purpose of this study is to evaluate the effect of motor cortex rTMS on chronic somatoform pain.

Chronic somatoform pain is common in psychiatric patients. Chronic somatoform pain causes significant distress and disrupts social functioning. Moreover, chronic somatoform pain often does not sufficiently respond to medication.

Chronic somatoform pain is associated with medial pain system. The medial pain system is comprised of structures engaged in affect and motivation, such as medial thalamus and limbic structures. The medial pain system gets inhibitory control from motor cortex. Functional neuroimaging studies indicate that chronic somatoform pain is associated with hypoactivity of motor cortex, defective inhibitory process, and hyperactivity of medial pain system.

Repetitive Transcranial Magnetic Stimulation (rTMS) is a safe and non-invasive tool to modulate neurophysiologic activity of the focal brain. Therefore, pain relief by rTMS can be obtained from motor cortex stimulation, restoration of defective inhibitory process, and deactivation of medial pain system. Studies have shown that motor cortex stimulation using rTMS can relieve pain in patients with neuropathic pain. However, to our knowledge, there is no rTMS study on chronic somatoform pain in psychiatric patients. The purpose of this study is to evaluate the effect of motor cortex rTMS on chronic somatoform pain.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of somatoform pain disorder, chronic

Exclusion Criteria:

* Neurological disorder
* history of epilepsy
A Survey to Evaluate the Rate of Abnormal Glucose Tolerance Among Hong Kong Chinese Subjects With Coronary Heart Disease

Hypothesis: there is a high prevalence rate of diabetes, including asymptomatic undiagnosed glucose intolerance, among subjects with coronary heart disease in Hong Kong.

A cross-sectional survey is planned to study the rate of undiagnosed diabetes and glucose intolerance among the Chinese patients with coronary heart disease in Hong Kong. The survey results will be important for us to plan the logistics to investigate and manage the potential glucose abnormality of our heart disease patient.

Diabetes is becoming an epidemic in Hong Kong, affecting over 10% of population and causing a major burden to the health care system. Over 30-40% of patients admitted to the medical wards of the Hospital Authority hospitals have diabetes as a contributory factor. It was estimated that thirty to fifty percent of patients with stroke, heart failure or acute myocardial infarction have diabetes as a key causative factor. However, the exact prevalence rate of diabetes, including asymptomatic undiagnosed glucose intolerance, among subjects with coronary heart disease is still unknown in Hong Kong. Many heart disease patients with undiagnosed diabetes remained being untreated on their abnormal glycemic status, which will further aggravate the heart disease and impair the prognosis.

The investigators plan to conduct a cross-sectional survey to study the rate of undiagnosed diabetes and glucose intolerance among the Chinese patients with coronary heart disease in Hong Kong. The survey results will be important for us to plan the logistics to investigate and manage the potential glucose abnormality of our heart disease patient.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 years
2. Subjects admitted to Hospital Authority hospital as in-patients (AHNH) with the diagnosis of coronary heart disease (ICD code 410-414) during the period 1 April 2007 to 31 March 2008.
3. Subjects admitted to AHNH for the procedure Percutaneous Coronary Intervention (PCI) to manage coronary heart disease.

Exclusion Criteria:

1. Known Type 1 diabetes defined as history of ketosis \[acute symptoms with heavy ketonuria (\>3+) or ketoacidosis\] or heavy ketonuria (3+) or continuous requirement of insulin treatment within one year of diagnosis and thereafter.
2. Patients with terminal malignancy or other life-threatening diseases with less than 6-month expected survival
3. Patients with a mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Stress Urinary Incontinence

The study will enroll only from the first 225 subjects who were randomly assigned to treatment in G201002 (irrespective of the treatment allocation, i.e., GTx-024 or placebo) and who have completed the 12-week treatment period and 16-week durability period to assess the long-term durability of response to GTx-024 on SUI symptoms. The extension study will follow subjects for an additional 20 weeks to help better assess the durability of response in these subjects and will provide additional efficacy and safety data for the subjects. Subjects will not be provided with any study treatments and will be off-drug during this extension study.


Eligibility Criteria:
Inclusion Criteria:

* Be one of the first 225 subjects who were randomly assigned to treatment in G201002 (Phase 2 study) and have completed the 12-week treatment and 16-week durability periods
* Be able to read, understand, and provide written, dated informed consent prior to enrollment in the current study (within 2 weeks of completing G201002) and be likely to comply with the study protocol and communicate with study personnel about AEs and other clinically important information
* Agree to maintain a stable dose of any medication known to affect lower urinary tract function, including but not limited to anticholinergics, tricyclic antidepressants, beta-3 adrenergic agonists, or α-adrenergic blockers, throughout the duration of the study

Exclusion Criteria:

* Starts any new treatment (medication, pelvic floor physical therapy, or other treatment known to impact the pelvic floor) after completing G201002 that is known or suspected to affect lower urinary tract function, including vaginal rejuvenation
* Has a current or past history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with interpretation of study results
An Open-label Controlled Trial: Effectiveness of Balneotherapy in Palmoplantar Psoriasis and Contact Dermatitis.

Patients who had an indication for phototherapy were included in this study. The treatment was used as a monotherapy protocol.

The standard protocol for bathing PUVA involved applying 0.01% bath psoralen for 15 minutes, while the tap water group only received a tap water bath for 15 minutes and the salt water group received 3% salted (NaCl) water before UVA treatment.

Main tools to assess the efficacy is disease activity scores and quaity of Life scores.

Patients who met the criteria for phototherapy were included in this study. The treatment was used as a standalone protocol, with only moisturizer permitted. In order to participate, patients needed to have completed their last systemic treatment at least 2 months prior to the study, and their last topical treatment at least 4 weeks prior.

Patients were randomized using a computer program and assessed at the beginning of therapy, as well as after 12, 24, and 36 sessions. The standard bath-PUVA protocol involved applying 0.01% bath psoralen for 15 minutes, while the tap water group only received a tap water bath for 15 minutes, and the salt water group received a 3% salt water bath before UVA exposure.

All patients were educated about their condition and current treatment options. Patients who participated in this study either had contraindications to other therapies or had experienced side effects previously.

The initial UVA dosage was 0.25 J/cm2, gradually increasing to a maximum of 5 J/cm2. During each evaluation, patients were assessed using various scales and tools to measure the severity of their psoriasis and their quality of life, as well as photographs.

Following a pilot study involving 5 patients in each group, a two score reduction in the disease activity score revealed that G power analysis determined that a total of at least 13 patients was needed to achieve 80% power. Ethical approval was obtained before commencing the study.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged between 18 and 65
* Clinical diagnosis of Palmoplantar Psoriasis or Contact Dermatitis

Exclusion Criteria:

* Individuals under 18 or over 65
* Pregnancy or breastfeeding
* History of malignancy
* Diagnosis of photodermatosis
* Prescription or use of photoallergenic or phototoxic drugs
A Study of DPC 817 in HIV-Infected Males

The purpose of this study is to evaluate DPC 817. The safety, dosages, and how the body responds to the drug will be studied.

The study will consist of two parts. Patients in Part A will receive a single dose of DPC 817 on two separate occasions and a placebo (a solution or tablet without the drug) on one occasion. Patients in Part B will receive two separate doses of DPC 817. Patients will be admitted to the clinical study unit the day before dosing (Day -1) and remain there for at least 48 hours after taking the study drug. Patients will return to the clinical study unit on Day 8 and Day 28 following the dose in the last treatment period. During the study there will be medical and medication histories taken, physical examinations, vital sign measurements, and routine clinical laboratory tests.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV positive
* Are male and are between 18 years of age (or the legal age of consent, whichever is older) and 55 years of age
* Are female and are between 18 years of age (or the legal age of consent, whichever is older) and 55 years of age and are not able to have children (females may participate in Part B only)
* Have no clinically significant findings on physical examination or clinical laboratory evaluations
* Have a CD4-lymphocyte count of 50 or more cells/mm3
* Are able and willing to comply with the requirements of this study

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have an opportunistic infection characteristic of AIDS
* Are receiving any approved or experimental HIV drugs. Any previous anti-HIV treatment must be stopped at least 4 weeks before the first dose of study medication
* Are pregnant or breast-feeding
* Are enrolled in other experimental drug studies or have recieved other experimental drugs within 30 days before the first dose of study drug
* Have any disease that causes a problem with absorption of drugs
* Have active hepatitis
* Have a history of pancreatitis or peripheral neuropathy
* Have received radiation therapy or chemotherapy within 30 days before the first dose of study drug
* Have received treatment with drugs that affect the immune system within 30 days before the first dose of study drug or have received an HIV immunotherapeutic vaccine
* Have taken prescription or over-the-counter products within 14 days of the first dose of study drug unless approved by the doctor
* Are unable to comply with the dosing schedule and study procedures
Nimotuzumab in Combination With Radio-chemotherapy for the Treatment of Brainstem Tumor in Children

The purpose of this study is to evaluate the safety and efficacy of nimotuzumab in combination of radio-chemotherapy for the treatment of brainstem tumor in children.

Nimotuzumab (h-R3), a recombinant humanized monoclonal immunoglobulin G1 antibody that binds to the extracellular domain of EGFR, which blocks the binding of EGF and transforming growth factor-α to EGFR. High expression of EGFR protein in glioma has been associated with tumor progression and enhanced tumorigenicity. Several clinical trials have demonstrated the anti-tumor effects of nimotuzumab, such as head and neck cancer and esophageal cancer15. The purpose of this study was to evaluate the efficacy of nimotuzumab in combination of radio-chemotherapy for the treatment of brainstem tumors in children.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be \>/= 3 and \</= 21 years of age.
* Patients must have a newly diagnosed or progressive brain stem tumor.
* If biopsy has been performed, patients with both high and low grade astrocytomas are eligible.
* Non-histologically confirmed brain stem tumors are eligible. Neuroradiographic confirmation of brain stem glioma is mandatory for study entry.
* Cervicomedullary junction tumors are ineligible.
* Patients with a diagnosis of NF-1 are ineligible.
* Patients must be registered within 6 weeks from diagnosis or recurrence.
* Patients must have life expectancy \> 6 weeks.
* Patients must have adequate hematologic and renal function: ANC \>1,000/ul, platelets\>100,000/ul and creatinine normal for age: \</= 0.7 mg/dl (age 3-10yrs.), \</= 1.0 mg/dl (11-12yrs.). and \</= 1.2 (13-21yrs.).
* Written informed consent must be obtained according to institutional guidelines.

Exclusion Criteria:

* Cervicomedullary junction tumors are ineligible.
* Patients with a diagnosis of NF-1 are ineligible.
* Pregnant or nursing women are ineligible.
* Patients must not start treatment until informed consent is given and the patient is registered.