cyrilzakka/clinical-trials huggingface dataset:
Muscle Characteristics Associated With Statin Therapy

The purpose of this study is to investigate the mechanism of statin-related myopathy by evaluating muscle samples before and after statin exposure.

Statins have been proven to reduce cardiovascular events and mortality in large clinical trials but remain underutilized partly due to the associated myopathy. Severe reactions manifested as rhabdomyolysis are rare but myalgia is commonly noted in clinical practice. The pathophysiology of these events remains obscure. Previous studies suggest that statins block the downstream products (such as cellular signaling molecules) of the mevalonate pathway needed for normal muscle function. Other studies show that statins are associated with gene expressions involved in muscle damage such as atrogin-1. We will quantify these entities pre and post statin therapy to better understand these reactions.

Eligibility Criteria:
Inclusion Criteria:

* Primary surgeon's permission.
* Patient is \> 21 years of age.
* Patient will go through a two phase surgery with the two procedures one to eight months apart.
* Patient or representative understands the nature of the study.
* Normal thyroid stimulating hormone (TSH).
* LDL-cholesterol \> 100 mg/dL or highly sensitive C-reactive protein (hsCRP) \> 2.0.
* One of the following risk factors: male \> 45 year old or female \> 55 year old, smoker, hypertension, first degree family history of coronary artery disease \< 55 year old, HDL \<40 mg/dL, chronic kidney disease, diabetes mellitus, previous TIA or stroke, previous coronary artery disease.

Exclusion Criteria:

* Has been on a lipid-lowering medication previously.
* Severe illness (e.g. trauma or sepsis) more than 24 hours before obtaining the first biopsy.
* Less than a 10% reduction of LDL after 3 months of therapy (indicative of non-adherence).
* Contraindications to statins such as liver failure.
* History of underlying muscle disorder.
* Taking amiodarone.
Epidural Anesthesia With Chloroprocaine Versus Lidocaine

Chinese made chloroprocaine has a rapid onset time, effective methodology, can last for a short time, provides fast motor recovery and causes no significant side effects.

Chloroprocaine hydrochloride is the chloridized local anesthetic of procaine hydrochloride, with twice the anesthetic intensity, four to five times the metabolization and half the side effect of procaine. The chloroprocaine hydrochloride product made in China has been on sale since 2002. To determine the clinical efficacy of low-epidural anesthesia with chloroprocaine versus lidocaine, the investigators carried out a prospective, randomized, double-blinded multi-centre clinical trial. The results demonstrate that epidural anesthesia using chloroprocaine has a more rapid onset time and shorter duration than with lidocaine. It can also provide a reliable sensory and motor block in epidural anesthesia, and is thus a more attractive alternative than lidocaine for middle and short duration surgical procedures.

Eligibility Criteria:
Inclusion Criteria:

* Weight no more than 80 Kg or not more than 20% of normal weight
* American Society of Anesthesiologists (ASA) grade I or II
* No obstacles in thinking or language communication
* No epidural puncture contraindications such as disturbances of blood coagulation, local infection of the puncture site or use of anticoagulants

Exclusion Criteria:

* Chronic obstructive pulmonary diseases
* Serious heart, liver, renal and metabolic diseases
* Cerebral thrombosis and sequela
* Serious dehydration and electrolyte imbalance
* Neuromuscular diseases
* Pregnant or parturient women
* Abnormal liver and kidney function
Physiotherapists' Placebo or Nocebo Communication Regarding VR

Rationale: Chronic musculoskeletal pain (CMP) is a common and disabling condition. Physiotherapy is the most frequently administered nonpharmacological treatment option for patients with CMP and recently virtual reality (VR) was introduced in physiotherapy care as a novel treatment modality. Proper communication about physiotherapy treatment (modalities) is important to improve treatment outcomes, by applying placebo effects enhancing communication and avoiding nocebo effects enhancing communication. However, yet is still unknown to what extent this applies to communication of physiotherapists about VR in healthy participants.

Objective: To determine the effect of physiotherapists' placebo or nocebo therapeutic communication about VR, on treatment credibility and expectation in healthy participants.

Study design: Web-based randomized controlled trial.

Study population: 126 participants

Intervention: The placebo intervention group will be shown an educational video about VR, containing placebo effects enhancing verbal language. The nocebo intervention group will be shown an educational video about VR, containing nocebo effects enhancing verbal language.

Primary study parameters: The primary study parameters are treatment credibility and treatment expectation. Treatment credibility and treatment expectations will be measured using the Dutch credibility and expectancy questionnaire (CEQ).


Eligibility Criteria:
Inclusion Criteria:

* aged ≥ 18
* access to the internet
* provide informed consent

Exclusion Criteria:

* lacked comprehension of the Dutch language
* had experience with therapeutic VR
* suffers from CMP
Combination of Nanoxel and Herzuma in Salivary Duct Carcinoma

1. Study outline This is a multicenter, single-arm, phase II trial to evaluate the efficacy and safety of nanoxel plus herzuma combination chemotherapy in patients with metastatic salivary ductal cancer. Approximately 41 patients will be enrolled. Treatment will be continued until disease progression or unacceptable toxicities. Response evaluation will be performed every 2 cycles.
2. Dosing \& Treatment schedule D1 Nanoxel 75 mg/m2 + D5W 100mL MIV over 1hr D1 Herzuma 8mg/kg (loading dose) + N/S 250mL miv over 90mins 6mg/kg (maintenance) + N/S 250mL MIV over 30mins (since 2 cycle) repeated every 3 weeks (In case of discontinuation of nanoxel without progression, single agent herzuma can be administered until progression)


Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed HER2 positive (immunohistochemistry \[IHC\] 3+, and/or fluorescence in situ hybridization\[FISH\] positive with ≥ two-fold amplification) salivary duct carcinoma(SDC), and other salivary gland carcinomas which are similar to SDC in histopathological findings, including adenocarcinoma, not otherwise specified, acinic cell carcinoma, squamous cell carcinoma, anaplastic carcinoma, high grade mucoepidermoid carcinoma, and carcinoma ex pleomorphic adenoma
* stage IV or recurrent cancer
* age ≥ 20 years
* ECOG performance status 0-2
* At least one measurable tumor lesion according to RECIST 1.1
* Expected survival for approximately 12 weeks or longer
* No prior systemic chemotherapy
* At least 4 weeks later after surgery or radiotherapy
* Written informed consent

Exclusion Criteria:

* Severe or unstable cardiac disease, including (for example) coronary artery disease requiring increased doses of anti-anginal medication and/or coronary angioplasty (including stent placement) within the preceding 24 months(congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias)
* Uncontrolled systemic illness such as DM, hypertension, hypothyroidism and infection
* Pregnant and nursing women (women of reproductive potential have to agree to use an effective contraceptive method)
* Current, known CNS malignancy (history of completely resected or irradiated brain metastases by WBRT or stereotactic radiosurgery allowed)
* Patients with alcohol abuse
Safety, Pharmacokinetics and Pharmacodynamics of TA-7284 in Type 2 Diabetic Patients

The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of TA-7284 orally administered once daily for 15 days (1 day followed by a 1 day washout period and then 14 consecutive days). Dose escalation design is utilized in this study, and dose escalation of TA-7284 will be starting with 25 mg (step 1). Subsequent doses of 100 mg (step 2), 200 mg (step 3) and 400 mg (step 4) are planned after review of the tolerance and PK of the previous step.


Eligibility Criteria:
Inclusion Criteria:

* Clinically stable Type 2 Diabetes Mellitus
* Females without childbearing potential
* Body mass index (BMI) \>= 18.5 kg/m2 and \<= 39.9 kg/m2
* Hemoglobin A1c levels \>= 6.5% and \<= 10%
* Fasting blood glucose levels \>= 140 mg/dL and \<= 270 mg/dL
* Systolic blood pressure \>= 95 mmHg and \<= 160 mmHg, and diastolic blood pressure \>= 50 mmHg and \<= 100 mmHg, and pulse rate \>= 50 bpm
* Patients who have not been administered anti-diabetic medication within 2 weeks Prior to dosing
* Medicines if necessary for Hypertension or Dyslipidemia should be administered with stable dosage at least 3 months
* Treatment with diet and exercise should be unchanged for more than 3 months

Exclusion Criteria:

* Type 1 Diabetes Mellitus or Secondary Diabetic Mellitus
* History of diabetic complications which need treatment
* Treatment with insulin, thiazolidinediones, thiazide diuretics、beta blockers or systemic steroids within 3 months prior to informed consent
* Serum creatinine \> upper limit of the normal range
* Patients with significant complications
Prenatal Diagnosis of Antenatal Midgut Volvulus: Specific Ultrasound Features

Objective:

The small bowel volvulus is a rare cause of intestinal obstruction which may occur in utero and whose prenatal diagnosis is difficult.Sonographic signs are mainly indirect and non specific.The aim of this study is to present a retrospective analysis of prenatal sonographicfindings in fetal segmental midgut volvulus.Thanks to this series the investigators could highlight the more specifics signs of the volvulus included a new pattern.

Objective:

The small bowel volvulus is a rare cause of intestinal obstruction which may occur in utero and whose prenatal diagnosis is difficult. Sonographic signs are mainly indirect and nonspecific. The aim of this study is to present a retrospective analysis of prenatal sonographic findings in fetal segmental midgut volvulus. Thanks to this series the investigators could highlight the more specifics signs of the volvulus included a new pattern.

Methods:

Unicentric retrospective analysis of cases of prenatal midgut volvulus between 2006 and 2017. The primary inclusion criteria was postnatal diagnosis of prenatal volvulus based on post-natal findings and prenatal imaging findings. The exclusion criteria was the absence of prenatal imaging assessment. The investigators collected the clinical history and the echographic mode B and color Doppler. They have searched for some specific sign like " whirlpool sign " representing the winding of the mesenteric vein around the superior mesenteric arterywith color Doppler with arciform pattern of the midgut, hydro-meconium level in the dilated loops and position of mesenteric vessels for evaluation of the intestinal (mal) rotation. Gold standard was surgery or foetopathology if performed.

Eligibility Criteria:
Inclusion Criteria:

* postnatal diagnosis of prenatal volvulus based on post-natal findings and prenatal imaging findings

Exclusion Criteria:

* the absence of prenatal imaging assessment
A Study of SSGJ-613 in Gout Subjects Initiating Urate-Lowering Treatment.

The purpose of this study is to determine the efficacy and safety of recombinant anti-interleukin-1β humanized monoclonal antibody injection in Chinese gout participants Initiating Urate-Lowering Treatment.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 Years to 75 Years, both male and female.
* BMI ≤40 kg/m2.
* Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of gouty arthritis.
* ≥2 acute gout flares within 1 year prior to screening.
* Willingness to initiate urate-lowering treatment or to initiate urate-lowering treatment within 7 days prior to administration.

Exclusion Criteria:

* Gout caused by radiotherapy/chemotherapy, organ transplantation, tumors, etc.
* Evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
* Presence of severe renal function impairment.
* Intolerance of subcutaneous injection.
* Known presence or suspicion of active or recurrent bacterial, fungal, or viral infection at the time of enrollment.
* Live vaccinations within 8 weeks prior to the start of the study.
* Use of forbidden therapy
Study Assessing the Effectiveness of a Cardiac Web-based eLearning Platform

In the trial cardiac patients will be provided with unrestricted access to the web-based eLearing platform for a one-month period.

Patients participating in the trial will be provided with a cardiac web-based eLearning platform for one month during study period. The medical content of the packages will be gathered from a multidisciplinary input of both medics (e.g. cardiologists) and paramedics (e.g. psychologists).

E-Learning packages type I: videos with information from caregivers. In these videos, medics and paramedics are interviewed to highlight the etiology, pathophysiology and treatment of coronary artery disease; the associated comorbidities and the ways to prevent recurrence.

E-Learning packages type II: videos in which patients are interviewed. Patients can help each other to adhere to their treatment plan, by sharing stories from their own experience about their illness and the rehabilitation afterwards. Short clips of maximum 2 minutes will be provided to study participants.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from coronary artery disease for which they are treated conservatively, with a percutaneous coronary intervention or with coronary artery bypass grafting

Exclusion Criteria:

* Patients with dementia or cognitive impairment not being able to sufficiently understand the E-Learning packages content
* (Foreign) patients unable to speak Dutch, thereby not being able to understand the content of the E-Learning packages
* Patients with advanced visual and/or auditory impairments, hindering them to adequately understand the E-earning packages
* Patients participating in another trial during the Pilot study period
* Patients refusing to provide signed consent
Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR)

The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with perennial allergic rhinitis (PAR).

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 6 Weeks in Adult and Adolescent Subjects 12 years of Age and Older with Perennial Allergic Rhinitis (PAR)

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of perennial allergic rhinitis (PAR).
* Must comply with study procedures and be literate.

Exclusion Criteria:

* Significant concomitant medical conditions.
* Use of corticosteroids.
* Use of allergy and other identified medications during the study.
* Current tobacco use or tobacco use within the past year.
* Exposure to an investigational study drug within the past 12 months.
* Clinically significant abnormal electrocardiograms (ECG) or laboratory abnormality.
Direct Full-stage Implantation of Sacral Neuromodulation

The purpose of this investigator-initiated study is to investigate the efficacy and costs of direct full stage sacral neuromodulation in patients with overactive bladder. Patients with refractory OAB and urge urinary incontinence will undergo direct full stage implantation and be followed for a period of 6 months to monitor symptom improvement with voiding diaries and validated questionnaires preoperatively and postoperatively. Therapeutic and adverse outcomes will be evaluated. The use of medical resources and time off of work will be analyzed as well. This will be a descriptive study with no additional arms or randomization.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years of age
* Female gender
* Refractory overactive bladder: wet failing treatment with two or more anticholinergic and/or beta-3 agonist agents
* Willing to stop treatment with anticholingeric and/or beta-3 agonist agents during the study period (2 week washout period preoperatively and 6 months postoperative)
* Willing and able to complete study questionnaires, use Medtronic device programmer, return for scheduled follow-up appointments
* Surgical candidate able to hold antiplatelet or anticoagulation prior to surgery
* Health insurance provider that will cover full-stage implantation

Exclusion Criteria:

* Age \<18
* Pregnant or planning to become pregnant
* Male gender
* Unable or unwilling to stop anticholingeric and/or beta-3 agonist agents during the study period
* Treatment with botulinum toxin within last 6 months
* Recent surgery for stress urinary incontinence or pelvic organ prolapse within last 6 months
* Severe pelvic organ prolapse
* Post-void residual \>150 ml
* Symptomatic or recurrent urinary tract infection
* Neurologic disorders: cerebrovascular accident with neurologic deficits, Parkinson's, multiple sclerosis, spinal cord injury, significant peripheral neuropathy
* Cognitive disorders, e.g. dementia
* Interstitial cystitis or chronic pelvic pain syndrome
* Poorly controlled diabetes mellitus (HbA1c \>10%)
* History of bladder malignancy, pelvic radiation, urinary retention requiring catheterization
* Anticipated or known need for MRI at the trunk
* History of or anticipated surgery at the lower back
* Unable to hold antiplatelet or anticoagulation prior to surgery
* Life expectancy \<1 year
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer

Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating women who have stage III or stage IV endometrial cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

OBJECTIVES:

I. Determine the feasibility of doxorubicin and cisplatin followed by whole abdominal radiotherapy in patients with stage III or IV endometrial cancer.

II. Determine the acute and chronic toxic effects, in particular, severe and life-threatening gastrointestinal, hepatic, and hematologic toxic effects, of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive doxorubicin IV and cisplatin IV on day 1. Treatment repeats every 3 weeks for 3 courses. Patients then undergo whole abdominal radiotherapy 5 days a week for 4-6 weeks.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 21-53 patients will be accrued for this study within 3.5 years.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed endometrial cancer including 1 of the following subtypes:

  * Clear cell carcinoma
  * Serous papillary carcinoma
  * Endometrioid adenocarcinoma
* Stage III or IV disease

  * Positive adnexa
  * Metastases to serosa, bowel mucosa, abdomen
  * Positive pelvic or paraaortic nodes
  * Positive pelvic washings or vaginal involvement within the radiation port
* Tumor must be surgically reduced to 2 cm or less within 8 weeks of study entry

  * Must have had a hysterectomy and bilateral salpingo oophorectomy
* No recurrent disease
* No distant metastases outside of abdominopelvic area, including:

  * Parenchymal liver metastases
  * Lung metastases
  * Positive inguinal lymph nodes
  * Positive supraclavicular nodes
  * Pleural effusion with malignant cytology
* Performance status - GOG 0-2
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT and alkaline phosphatase no greater than 3 times ULN
* Creatinine no greater than ULN
* Cardiac ejection fraction greater than 50%
* No other prior or concurrent malignancy within the past 5 years except nonmelanoma skin cancer
* No prior chemotherapy
* No prior pelvic or abdominal radiotherapy
* No prior radiotherapy for other prior malignancy
Suan Tsao Jen Tang for Treating Menopause With Sleep Problem: a Clinical Observation

A prospective follow-up study was carried out in the Yang Ming branch of the Taipei City Hospital.Climacteric women with sleep difficulty received SZRT at a rate of 4.0 g, thrice daily for four weeks.

A prospective follow-up study was carried out in the Yang Ming branch of the Taipei City Hospital between April 2008 and April 2010. Sixty-seven climacteric women with sleep difficulty received SZRT at a rate of 4.0 g, thrice daily for four weeks. Baseline scores were measured on the Pittsburg Sleep Quality Index (PSQI), followed by further measures at the end of weeks one and four. The World Health Organization Quality of Life (WHOQOL) assessment and the Menopause Rating Scale (MRS) were undertaken as secondary outcomes. Regression models were constructed to explore the score differences between the baseline and at weeks one and four by various determinants including age, body mass index (BMI), and severity of baseline menopausal symptoms. Among 99 surveyed patients, 67 and 61 were screened for intention to treat (ITT) and per-protocol population set analysis, respectively. Statistically significant reductions in the PSQI index scores evidenced on the fourth week.

Eligibility Criteria:
Inclusion Criteria:

1. Climacteric women, ranging from 40-65 years of age
2. Pittsburg Sleep Quality Index (PSQI) of greater than six
3. Falling asleep more than 45 minutes or slept less than six hours

Exclusion Criteria:

1. Within three months of the study there had been a major incident
2. Working the nightshift
3. Lack of time or timing conflicts
4. Pychosis, severe depression, obstructive sleep apnea-hypopnea, cardiac arrhythmia, acute myocardial infarction, high blood pressure, diabetes, or cancer
5. Currently taking pharmaceuticals that affect melatonin, acetylcholine, glutamate, serotonin, norepinephrine, GABA, histamine, adenosine, or prostaglandins
6. Inability to read and fill out the forms for the study
7. Any evidence of renal or liver dysfunction as defined by a level of at least 1.5 times of the upper reference limit