cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Photodynamic Therapy for Bile Duct Invasion of Hepatocellular Carcinoma

The prognosis of patients with obstructive jaundice caused by hepatocellular carcinoma (HCC) is dismal even after biliary drainage; due to malfunction of the biliary drainage tube caused by hemobilia and/or tumor emboli. Photodynamic therapy (PDT) in hilar cholangiocarcinoma improves biliary drainage and prolongs survival. The aims of this study were to assess the safety and efficacy of PDT in unresectable HCC with bile duct invasion.

As more therapies are available for patients with hepatocellular carcinoma (HCC), the survival rate has improved. The incidence of jaundice in patients with HCC is reported as 5-44%, and substantial number of patients experience obstructive jaundice. With the improvement of survival in patients with HCC, it is not uncommon to encounter HCC patients with obstructive jaundice in clinical practice.

The prognosis of patients with obstructive jaundice caused by HCC is dismal due to progressive liver failure, rapid tumor progression and ineffective biliary drainage. The mean survival of HCC with obstructive jaundice after biliary drainage ranges from 2.5 to 4.5 months. Effective biliary drainage to improve jaundice and liver function is inevitably needed for further treatment. However, it is difficult to maintain the patency of the bile duct because recurrent obstruction frequently develops due to hemobilia.

Photodynamic therapy (PDT) with biliary drainage is a promising treatment option for advanced cholangiocarcinoma. Presence of the photosensitizer only itself is nontoxic, but showing light with specific wavelengths can induce cytotoxicity. The systemically administrated photosensitizer accumulates preferentially in proliferating tissue. If this targeted lesion is then illuminated by light of a specific wavelength, the activated photosensitizer generates reactive oxygen species, which trigger cell death by apoptosis and necrosis of the cells in the specific area. Experience with PDT in cholangiocarcinoma suggests that a survival benefit can be achieved by prolonged relief of the obstruction.

The investigators hypothesized that conducting PDT with biliary stenting in patients with obstructive jaundice caused by bile duct invasion of HCC would improves stent patency and other clinical outcomes. The aim of this study was to evaluate the safety and efficacy of PDT in HCC patients with bile duct invasion.

Eligibility Criteria:
Inclusion Criteria:

* Known HCC: Diagnosis of HCC based on the 2005 AASLD (American Association for the Study of Liver Diseases) practice guidelines
* Unresectable HCC: Determined based on the BCLC (Barcelona-Clinic-Liver-Cancer) staging and treatment system
* Bile duct invasion of HCC: Confirmed by pathology via endoscopic retrograde cholangiopancreatogram (ERCP) or percutaneous transhepatic biliary drainage (PTBD). In case pathological diagnosis is clinically impossible, confirmed by dynamic CT or MRI showing that typical arterial enhancing mass in dilated bile duct and previous HCC diagnosis.

Exclusion Criteria:

* Severe renal disease
* Severe cardiac disease
* Bleeding tendency
* Porphyria
Audiologic Assessment of Call Center Operators

1. Early detection of hearing affection in call center operators
2. Study the effect of this type of noise on the auditory brainstem response.

Occupational noise-induced hearing loss (ONIHL) is a common occupational disease as it is estimated that 1.3 billion people were suffering of hearing loss due to noise exposure. Worldwide, occupational noise exposure is responsible for 16% of cases of disabling hearing loss in adults Commonly, hearing loss interferes with communication and can hinder personal attention and cognition. Older people with mild hearing loss have a twofold increased risk of dementia, whereas those with severe hearing loss have a fivefold increased risk of dementia.

In the last years there was increase in the number of new forms of workplaces, such as call centers. In accordance with the British Health and Safety Executive, a call center is defined as a work environment where all basic employee's tasks are completed simultaneously by phone and on PC. The very first call centers appeared in Europe in Sweden, in the mid-70's of the last century. The last decade brought rapid development of call centers proven by 10percent growth in employment in this sector between 2002and 2007.

Sources of noise occurring in offices can be divided into four categories:

* human activity (for example: noise created by walking people, phone calls including speaker systems),
* office equipment (for example: computers, printers, copy machines, faxes , ringing phones , net devices, mobile headsets),
* building indoor installations (for example: ventilation , heating system and air condition system-HVAC.hydraulic and lift systems),
* outdoor noise (most often a result of traffic).

There are many factors that have impact on indoor noise level such as outside area noise ,neighbor workers from the side as well as from the upper and lower levels activity and finally ,the call center technical equipment, The loudest systems with regard to the last one are ventilation and air condition, in accordance to research , the level of background noise is not high (54-60db) and should not be considered to be a threat towards health ;however, due to focusing employee's involuntary attention on information delivered by noise ,it should be seen as an annoying factor.

To minimize negative auditory health effects on workers in call centers, it is important to assess, and diagnose early occupational hearing loss (OHL) and tinnitus among them. As, early reporting, diagnosis, and intervention can limit the severity of, OHL as it is mostly irreversible. To our knowledge no local previous studies were done in this area.

Eligibility Criteria:
Inclusion Criteria:

* Active working workers in call centers with minimum exposure 2year.
* Had no previous auditory problems.
* Their ages between \[18-50\] years old working at call centers from 6-12hours/day,5-6days a week.

Exclusion Criteria:

1. evidence of systemic illness \[ cardiovascular, renal and diabetes\]
2. previous history of hearing loss and tinnitus before working at the call center.
3. History of noise, ototoxic drugs and chemotherapy.
Visual and Economic Profits of ReSTOR® Multifocal Intraocular Lenses (IOL) on Public Health Patients in Spain

Surgical correction of presbyopia is possible via the implantation of multifocal intraocular lenses after removal of the crystalline lens. The cost of these implants is approximately 6 times higher than the conventional monofocal implants routinely used in all crystalline surgery for correction of the resulting ametropia. Spectacles for correcting presbyopia, which are necessary after the insertion of monofocal implants, may also have a significant cost.

The proposed trial will involve two randomized groups of patients in need of crystalline/cataract surgery, with monofocal or multifocal lens implants (the same type of lens in both eyes) leaving them emmetropic for distant vision.

The objective is to corroborate with blind-evaluation the effectiveness of multifocal lens implants in obviating the need for glasses to correct presbyopia, to evaluate the benefits of this type of implant, both in global economic terms (adding the cost of the implants to that of corrective glasses where necessary) and in terms of the improved quality of life of the patients, and to confirm the absence of adverse effects.

Findings will be subjected to a statistical quantification.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes aged 50 and over, with fully-established presbyopia, requiring phacoemulsification + IOL as the surgical technique for the removal of their cataracts.
* Their capsular bags should be stable, with keratometric astigmatism equal to or lower than 1 diopter.
* Biometric calculations should indicate an IOL for emmetropy within the common dioptric range for both lenses, i.e. between +6 y +34.

Exclusion Criteria:

* Previous corneal refractive surgery
* Maculopathy, amblyopia or other eye conditions that limit visual power
* Occupations requiring special driving licenses
* Keratometric astigmatism higher than 1 diopter
* Any intraoperative posterior capsular rupture or extracapsular reconversion.
Treating Apoplectic Sequela With Acupuncture: a Randomized Controlled Study

The purpose of this study is to evaluate the therapeutic effect of acupuncture method of "Xing Nao Kai Qiao" for paralysis as an apoplectic sequela in a multicenter randomized and controlled clinical trial and to compare the efficacy between acupuncture and rehabilitation therapy. In addition, evaluating the trial in the view of medical economics.

This study is a multi-center randomized controlled trial comparing three treatment groups.The trial is completed in the following three hospitals: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (TCM) of China, Tianjin Hospital of TCM of China, and Qingdao Haici Medical group of Shangdong province of China.

The total observation period within this study is 24 weeks for each patient. All patients should remain hemiplegia within 15～90 days after stroke. After randomization the patients will receive 4 sessions of 30 minutes' duration during a period of 4 weeks. The outcome measurement is completed both in the different times as follows: before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.

288 patients were randomised into three groups: acupuncture group, rehabilitation group,and acupuncture plus rehabilitation group.The patients in the three groups are blinded as to which treatment method they received. The central randomization is used in this trial, which is performed by the Drug Clinical Research Center of Shanghai University of TCM of China. This trial is performed according to the principles of the Declaration of Helsinki (Version Edinburgh 2000). And the trial protocol has been approved by local institutional review board and ethics committee.

Eligibility Criteria:
Inclusion Criteria:

1. Cerebral infarction diagnosed according to the diagnostic standard of western medicine
2. Apoplexy diagnosed according to the diagnostic standard of traditional Chinese medicine for apoplexy
3. Cerebral vascular accident occured in the internal carotid artery system which was verified by cerebral CT or MRI
4. The incidence of apoplexy less than twice and the time of onset 15\~3 months
5. Age: 40-75 years, non-limited gender
6. NDS score of limb functional defect ≥10
7. The patient was alert and the vital signs are stable
8. Participant signed the informed consent form

Exclusion Criteria:

1. TIA or RIND
2. The nerve function defect induced by the cerebral tumor, trauma, parasitic diseases, heart disease and metabolic disorder or hemorrhagic cerebrovascular disease
3. Pregnant or breast-feeding women
4. Complicated with severe primary disease in heart, liver, kidney and hematology system or psychopath
Genetics of Response to Canagliflozin

Five daily doses of canagliflozin (300 mg) will be administered to healthy volunteers. Pharmacodynamic responses to canagliflozin will be assessed both at 2 days and 6 days after administration of the first dose of canagliflozin. A genome-wide association study (GWAS) will be conducted to search for genetic variants that are associated with each of the pharmacodynamic responses to canagliflozin.

After obtaining informed consent, healthy Amish research subjects will be screened for eligibility. Immediately after obtaining blood samples for baseline clinical chemistry tests wills, patients will initiate 5 days of canagliflozin (300 mg) treatment. Fasting blood samples will be obtained to assess pharmacodynamic responses at both 48 hours and 120 hours after initiating canagliflozin. The principal pharmacodynamic responses will include 24 hour urinary excretion of glucose, serum chemistries (phosphorus, FGF23, 1,25-dihydroxyvitamin D, parathyroid hormone (PTH), glucagon, beta-hydroxybutyrate, acetoacetate, procollagen type I N-terminal peptide (P1NP), and beta-CTX). Research subjects will undergo genotyping, and a genome-wide association study will be conducted to search for genetic variants that are associated with pharmacodynamic responses to canagliflozin.

Eligibility Criteria:
Inclusion Criteria:

* Of Amish descent
* Age 18 or older
* BMI: 18-40 kg/m2

Exclusion Criteria:

* Known allergy to canagliflozin
* History of diabetes, random glucose greater than 200 mg/dL, or HbA1c greater than or equal to 6.5%
* Currently taking diuretics, antihypertensive medication uric acid lowering medications, or other medication that the investigator judges will make interpretation of the results difficult
* Significant debilitating chronic cardiac, hepatic, pulmonary, or renal disease or other diseases that the investigator judges will make interpretation of the results difficult or increase the risk of participation
* Seizure disorder
* Unwilling to go off of vitamin supplements and over the counter medication (except for acetaminophen) for at least two weeks prior to the first home visit and agree to avoid these medications for the duration of the study.
* Positive urine human chorionic gonadotropin test or known pregnancy within 3 months of the start of the study
* Estimated glomerular filtration rate less than 60 mL/min
* Currently breast feeding or breast feeding within 3 month of the start of the study
* Liver function tests greater than 2 times the upper limit of normal
* Hematocrit less than 35%
* Abnormal thyroid hormone stimulating hormone
Usability of Diabetes Dashboard Embedded Within a Patient Web Portal

The purpose of this study is to conduct a prospective, longitudinal study to evaluate the usability of a patient-facing diabetes dashboard delivered via an established patient web portal.

Up to 70 adult patients with type 2 diabetes mellitus will be enrolled and given access to a diabetes dashboard within an existing patient web portal. Patients will be invited by mail (or email) to be screened for enrollment in the study. Patients may also respond at a study flyer and contact the study team to be screened for enrollment. Eligible and interested patients will be emailed a link to a secure study website where they will complete a web consent form. After enrollment, participants will complete a baseline web-based questionnaire. After completing the enrollment questionnaire, they will be provided access to the diabetes dashboard within the patient web portal for one month. After one month, participants will receive an additional follow-up (final) questionnaire to assess outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus
* Currently being treated with at least one antihyperglycemic medication
* Able to speak and read in English
* Have reliable access to a computer with internet access
* Existing My Health at Vanderbilt (i.e., patient portal) account

Exclusion Criteria:

* Living in long term care facilities
* Known cognitive deficits
* Severe visual or hearing impairment
* Unintelligible speech (e.g., dysarthria)
* Currently participating in another diabetes-related research study
Different Types of Manual Therapy Techniques in Patients With Chronic Neck Pain

The purpose of this study was to investigate the comparative effectiveness of high velocity and low amplitude (HVLA)vs Mobilization (Mob) vs Mobilization with movement technique (MWMT) in sample of patients with chronic neck pain (CNP). Secondly to evaluate the immediate effects in range of motion and pain thresholds, and the interaction between psychological factors and the outcomes of these three types of manual therapy.

The hypothesis is that all manual therapies techniques will produce similar effects.

The randomized controlled trial included patients with mechanically reproducible CNP, ≥ age 18-years who are randomized into three groups of treatment. The main outcome measures were the Visual Analogue scale (VAS), and, with secondary measures of Neck Disability Index (NDI), Global Rating Of Change (GROC), Cervical Range Of Motion (CROM), Pressure Pain Threshold (PPT), State Trait Anxiety Inventory (STAI-T), Beck depression Inventory (BDI-II), Tampa Scale for Kinesiophobia, Pain Catastrophizing Scale (PCS).

Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of Chronic neck pain

Exclusion Criteria:

* Neck pain is associated with whiplash injuries.
* Resting blood pressure greater than 140/90 mmHg.
* Cervical radiculopathy.
* Cervical disc herniation.
* Fibromyalgia syndrome.
* Previous neck surgery.
Effect of MA Versus TENS for Primary Dysmenorrhea

The trial aims to evaluate the effect of manual acupuncture versus transcutaneous electric nerve stimulation in treating primary dysmenorrhea.

According to systematic reviews,manual acupuncture(MA) and high frequency transcutaneous electric nerve stimulation(TENS) had certain therapeutic effects on primary dysmenorrhea respectively.

In this trial, 84 patients with primary dysmenorrhea will be recruited and randomly allocated into MA group and TENS group. Patients in MA group will receive treatment at acupoints of Shiqizhui(EX-B8), Ciliao(BL 32),Diji(SP 8) and Sanyinjiao(SP 6) and those in TENS group will receive treatment at the area along the lower borders of the ribs and the upper borders of the hip crests on both sides. All patients, both in EA group and TENS group, will be treated in their first day of dysmenorrhea, once a day for three consecutive days. And the treatments will last for three consecutive menstrual cycles.

Eligibility Criteria:
Inclusion Criteria:

1. Female;
2. Aged of 18 to 40 years;
3. Conforming to the criteria for the diagnosis of primary dysmenorrhea in the guideline developed by Society of Obstetricians and Gynaecologists of Canada（SOGC）in 2017.
4. With normal menstrual cycle(28±7 days) and normal menstrual period（3-7days）；
5. Menstrual mean pain score ≥4 on the numerical rating scale (NRS)；
6. To sign the informed consent and participate in the study voluntarily.

Exclusion Criteria:

1. Secondary dysmenorrhea;
2. Pregnant patients,lactating patients or patients preparing pregnancy.
3. Subjects with serious heart, liver, kidney damage or cognitive impairment, aphasia, mental disorders, or the inability to cooperate with the examination and treatment;
4. Subjects with coagulation dysfunction or anticoagulants such as warfarin and heparin have been used all the time;
5. Subjects installed with the cardiac pacemaker;
6. Those who have received relevant acupuncture, transcutaneous electric nerve stimulation and other treatment (except pain medication) the last three months;
7. Patients who may be allergic to electrodes.
Nimotuzumab Concurrent With Chemoradiotherapy for Esophageal Cancer Patients

Elderly or malnourished patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) had poor prognosis. Radiotherpy was an important and effective treatment in treating ESCC. The present study is a one-arm trial that seeks to evaluate the efficacy in patients with unresectable ESCC. The study objectives include R0 resection rate, complete pathological response and treatment toxicity, etc.

Nimotuzumab is a recombinant humanized monoclonal antibody against EGFR. Its efficacy and safety in patients with esophageal cancer have been confirmed by many studies.

The current prospective phase II study aimed to evaluate the efficacy and safety of a combination regimen comprising chemotherapy with nimotuzumab with a dose of 800mg per week and S-1 and concurrent radiotherapy for patients who are elderly or malnourished.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed esophageal squamous cell carcinoma.
* No previous treatment for the esophageal carcinoma.
* KPS score ≥70.
* NRS-2002 score≥2.
* Main organs and bone marrow function are normal: routine blood tests: hemoglobin (Hb) ≥100g/L ; absolute neutrophil count (NEUT)≥1.5×109/L; platelets (PLT) ≥100×109/L; white blood cell (WBC)≥3.5×109/L,biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×UNL; serum total bilirubin (TBIL) ≤1.5×UNL; serum creatinine ( Cr) 1.0×1.5UNL, and BUN≤1.0×UNL;

Exclusion Criteria:

* Previous treatment of the esophageal cancer with surgery, radiation, or chemotherapy.
* Those combined with other primary malignant tumors other than esophageal cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
* At the time of diagnosis, there were distant and hematogenous metastases beyond the supraclavicular lymph node region, including retroperitoneal multiple lymph node metastasis, bone metastasis, brain metastasis, lung metastasis, liver metastasis, malignant pleural effusion and ascites
* There are active infections, such as active tuberculosis and hepatitis
* There are contraindications to targeted therapy.
A Treatment for Severe Inflammatory Acne Subjects

Demonstrate that a daily treatment regimen of adapalene 0.3%/benzoyl peroxide 2.5% gel + oral Doxycycline 200 mg is effective and safe in severe inflammatory acne with 3 or fewer nodules or cysts (non-nodulocystic) during a 12-week treatment period.

This Phase 4, 12-week, single-arm, open-label, multi-center investigational efficacy and safety study was conducted in subjects with severe inflammatory acne. Subjects who met the inclusion criteria and none of the exclusion criteria at the Screening visit returned to the clinic for baseline measures (Week 0) and to start treatment, which continued for up to 12 weeks.

Treatment consisted of 2 investigational study drugs:

* A/BPO 0.3%/2.5% gel applied to dry skin as directed by study staff once daily for 12 weeks, at night after washing.
* Doxycycline hyclate 200 mg: each subject was to take 2 50-mg tablets of doxycycline hyclate in the morning and 2 at night, for a total of 4 tablets (a total of 200 mg) daily for 12 weeks.

Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female subjects, 12 years of age or older at Screening visit.
2. Subjects with a clinical diagnosis of severe inflammatory acne (IGA score of 4).
3. Subjects with 4 or fewer nodules or cysts \> 1 cm in diameter on the face.
4. Subjects 18 years of age or older must read and sign the Informed Consent Form, which includes Photography Consent and HIPAA authorization, prior to any participation in the study. Consent will be obtained prior to any study-related procedures. Subjects under the age of 18 years must sign an Assent to Participate Form to participate in the study and must have one parent or guardian read and sign the Informed Consent Form prior to any study-related procedure. (The parent or guardian is not required to attend the following visits unless requested.)

Key Exclusion Criteria:

1. Subjects with nodulocystic or conglobate acne, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.).
2. Subjects with 5 or more acne nodules or cysts \> 1 cm in diameter on the face at Screening and Baseline visits.
3. Female subjects who are pregnant, nursing, or planning a pregnancy during the study.
4. Subjects who have used any systemic therapy directed at improving acne, including antibiotics, within 30 days prior to Baseline visit.
5. Subjects who are at risk in terms of precautions, warnings, and contraindications for the investigational study drugs (see Appendix 14.1 for package inserts for adapalene 0.3%/benzoyl peroxide 2.5% gel and doxycycline hyclate Tablets).
6. Subjects with any other condition or circumstance which, in the Investigator's opinion, may put the subject at risk (e.g., a history of significant renal disease with impairment of renal function), confound the study results, or interfere with the subject's participation in the study.
7. Sponsor and study site staff, relatives of staff members, or other individuals who would have access to the clinical study protocol.