cyrilzakka/clinical-trials huggingface dataset:
Acupuncture Treatment in Adults Undergoing Diagnostic OGD : A Double-Blind Placebo Controlled Randomized Trial

To find out how the application of acupuncture needles to the proposed acupuncture points: Heart 7 (HT 7) and Pericardium 6 (PC 6) for reducing anxiety during Esophago-gastro-duodenoscopy (EGD)

Acupuncture is being used as one part of Chinese medicine for more than 2,500 years in treating diseases. Recent functional magnetic resonance imaging demonstrated that acupuncture can suppress the "pain" area in the brain so as to reduce the pain that felt by human subjects. Western medicine proposed the acupuncture mechanisms as to "provoke the release of endogenous substances" from central nervous system so in reducing pain. Many studies had been done using acupuncture in reducing pain for post-operation period, however, most of them were not very systematic and even some of them are leak of control group. Furthermore, to our knowledge, the use of acupuncture for reducing anxiety during EGD has not been previously investigated.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 undergoing elective unsedatant diagnostic EGD
* belonging to American Society of Anesthesia (ASA) classes 1 to 2

Exclusion Criteria:

* History of gastrectomy, esophagectomy, Whipple's operation and other gastrointestinal operations
* ASA class 3 to 4
* Pregnancy
* Allergy to acupuncture needles
* Request sedation
* Previous experiences of EGD
Randomized Controlled Trial of MRI Target Biopsy: Transrectal vs. Transperineal

This prospective study of comparing between Transrectal and transperineal prostate MRI targeted biopsy to provide evidence for clinicians to select the appropriate biopsy approach under different conditions.

This prospective study of comparing transperineal (TP) prostate MRI targeted biopsy with transrectal (TR) prostate MRI targeted biopsy was aimed to provide evidence for clinicians to select the appropriate biopsy approach under different conditions. TP (n = 75) and TR (n = 75) will be performed randomly for 150 patients who are suspicious of prostate cancer (PCa). The cancer detection rate (CDR), complication rate, visual analog scale (VAS) score, most painful procedure, number of repeated biopsy and additional anesthesia, and operating time (starting from lying down on the operating table to getting up) will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* prostate-specific antigen \> 4ng/ml
* Palpation is positive

Exclusion Criteria:

* older than 80y
* prostate-specific antigen \> 100 ng/ml
Evaluation of Bone Architecture and Bone Strength in Adults With Hypophosphatasia (HPP)

The study aims to evaluate the bone architecture and bone strength in adults with Hypophosphatasia (HPP).


Eligibility Criteria:
Inclusion criteria HPP-Group:

* Genetically verified HPP
* Age: ≥ 18 years
* Persistently low levels of alkaline phosphatase (ALP) ≤ 35 U/L (normal range 35-105 U/L)
* At least one of the following symptoms: a) dental manifestations; b) musculoskeletal pain; c) history of fracture(s)
* Submitted informed consent

Inclusion Criteria Control-Group:

* No ALP measurements ≤ 45 U/l and ≥ 50% of all ALP measurements, registered in the electronical clinical journal ≥ 55 U/l
* Normal parathyroid hormone (PTH) and Pyridoxal-5´-phosphate (PLP)
* Vitamin D3 ≥ 25 nmol/L
* Submitted informed consent

Exclusion criteria HPP-Group:

* Pregnancy
* Skin infection or severe skin affection in the measurement area of microindentation
* Known allergy to Lidocain
* Former or current medical treatment influencing bone metabolism (oral corticosteroid \> 12 weeks, former or current anti-osteoporosis treatment at any time (regardless drug holiday), all kind of sex steroids (excluding oral contraception), anti-convulsants)
* Current malignant disorders

Exclusion Criteria Control-Group:

* Family history of a genetic metabolic bone disease (HPP, Osteogenesis imperfecta)
* Rickets in childhood
* Former or current Osteoporosis
* Former or current Osteomalacia
* Known diabetes
* Former or current medical treatment influencing bone metabolism (oral corticosteroid \> 12 weeks, former or current anti-osteoporosis treatment at any time (regardless drug holiday), all kind of sex steroids (excluding oral contraception), anti- convulsants)
* Skin infection or severe skin affection in the measurement area of microindentation
* Chronic liver or gallbladder disease
* Current malignant disorders
* Former or current thyrotoxicosis (T4 over normal range ≥ 6 months)
* Cushing disease
* Pregnancy
Correlation Between Postprandial Hypotension and Post-induction Hypotension in the Elderly.

Postprandial hypotension (PPH) and post-induction hypotension (PIH) are very common in the elderly population and are associated with a variety of poor outcomes.The purpose of this study is to investigate the correlation between PPH and perioperative adverse events such as PIH in the elderly.

With the deepening of the aging population in our country, the number of elderly patients undergoing surgery is also increasing. Elderly patients are at higher risk for hemodynamic instability due to organ dysfunction, decreased physiological reserve, and the coexistence of multiple chronic diseases.Postprandial hypotension (PPH) is common but often unrecognized among the elderly.PPH is defined as a fall in systolic blood pressure of \>20 mm Hg, or a decrease to ≤90 mm Hg when preprandial systolic blood pressure is ≥100 mm Hg within 2 hours of a meal.The pathophysiology of PPH is not clear, the decreased cardiovascular autonomic function may play an important role. Post-induction hypotension (PIH) occurs after induction but before surgical incision and autonomic dysfunction is regarded as one of the major mechanisms.This study aims to prospectively explore the correlation between PPH and perioperative adverse events such as PIH in the elderly.

Eligibility Criteria:
Inclusion Criteria:

1. Elderly patients (≥ 65 years old）;
2. Elective non-cardiac surgery;
3. Patients with American Society of Anesthesiologists(ASA) grade I-III;
4. Patients will undergo general anesthesia by endotracheal tube;
5. Patients who are willing to participate in this research.

Exclusion Criteria:

1. Severe vascular disease;
2. Secondary hypertension;
3. Chronic kidney disease (CKD) stage 5;
4. Unable to measure upper extremity blood pressure accurately;
5. Dental or oral swallowing disorders or unable to eat independently;
6. Patients or their families refuse to participate in this research.
Pazopanib and Paclitaxel for Non-Small Cell Lung Cancer

Lung cancer is the leading cause of cancer worldwide with approximately 1.2 million new cases each year. Non-small cell lung cancer (NSCLC) accounts for greater than 80% of all lung carcinomas in Western countries. Surgical resection is the treatment of choice for patients with early stage disease (Stage I and II), but at least 50% of these patients will relapse locally and/or develop distant metastases. Furthermore, 70% of patients with NSCLC are non-resectable at the time of their diagnosis due to either locally advanced or metastatic disease. The long-term prognosis for patients with NSCLC remains poor with the overall 5-year survival rate less than 15%. The low survival rate may be attributed to the high incidence of unresectable disease at presentation and the inability of systemic therapy to cure metastatic disease. There is a clear need for improvement in the treatment of NSCLC.

The primary objective of this study is to evaluate the objective response rate of pazopanib in combination with paclitaxel in the treatment of subjects with advanced NSCLC. Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1). A subject is defined as a responder if he/she sustains a complete response (CR) or a partial response (PR) for at least 4 weeks at any time during treatment. A subject without a post-baseline assessment of response will be considered a non-responder.

A secondary objective of this study is to evaluate the safety and tolerability of pazopanib in combination with paclitaxel in the treatment of subjects with advanced NSCLC. Safety and tolerability endpoints will consist of the evaluation of adverse events (AEs), exposure, withdrawals due to AEs, dose reductions or interruptions, and changes from baseline in vital signs and clinical laboratory parameters.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of Stage IIIB (with confirmed malignant pleural effusion) or Stage IV NSCLC.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* No prior systemic first-line therapy for Stage IIIB/IV NSCLC with chemotherapy or any other biologic therapy. Prior surgery and/or localized irradiation for NSCLC are permitted. Palliative radiation therapy must have ended 14 days prior to first dose of pazopanib. Subject with recurrence after previous NSCLC that has been treated with surgery with or without adjuvant chemotherapy/radiation for curative intent are eligible, provided 12 months have passed since this treatment ended.

Exclusion Criteria:

* Appropriate for doublet therapy as first line therapy. At discretion of investigator.
Prevention of Cardiovascular Disease Using a Single PolyPill in an Urban Population - Focus on Liver-Related Variables.

The primary purpose of this study is to determine the effects of a fixed dose combination of valsartan, hydrochlorothiazide, atorvastatin and aspirin (PolyPill) on prevention of cardiovascular events in adults older than 50.

Various liver-related variables will also be recorded which will allow studying the effects of PolyPill on the liver and the effect of liver diseases such as nonalcoholic steatohepatitis on cardiovascular events and the protective effect of PolyPill.

2400 subjects will be randomly selected from participants of the Golestan Cohort Study (GCS) who are living in Gonbad and are over 50 years old. These subjects will be randomized to either receive PolyPill or no treatment.

Those agreeing to the study will undergo additional measurements (in addition to the baseline measurements performed in the GCS) including liver-related tests such as liver enzyme levels, abdominal ultrasonography and liver stiffness measurement. Some additional tests such as color doppler ultrasonography of carotid vessels will also be performed.

Subjects in the PolyPill arm who have no contraindication for the components of the pill will receive a single daily dose of PolyPill for 5 years.

Eligibility Criteria:
Inclusion Criteria:

- Being enrolled in Golestan Cohort Study

Exclusion Criteria:

* Debilitating disease causing inability to comply
* Contraindications to any of the components of PolyPill
* Not consenting to the study
Reducing Anxiety in Pediatric Dental Patients Through Passive Music Therapy

The purpose of this study is to determine if passive music listening decreases anxiety in patients undergoing dental procedures and if the effects of music therapy are influenced by gender, age, and amount or type of dental treatment needed.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists Physical Status Classification System I (ASA I) I and American Society of Anesthesiologists Physical Status Classification System II (ASA II)
* Patient needs restorative procedure (with or without local anesthesia or nitrous oxide)
* Received previous dental restorative treatment (detected via visual or radiographic evidence of previous restoration - no additional radiographs will be exposed for this study; exposed radiographs will be previously obtained, as needed,for comprehensive or periodic dental reasons)

Exclusion Criteria:

* Patients with hearing impairments
* Uncooperative patients at examination appointment (detected by Frankl behavior score of 1 or 2)
Pharmacokinetics and Pharmacodynamics of Buprenorphine in Healthy Volunteers

The purpose of this study is to determine the amount of buprenorphine and its metabolites in blood and urine after administration of 0.6 mg buprenorphine in healthy volunteers. Furthermore the purpose is to correlate the amount of buprenorphine in the blood with the effect on the ability to concentrate and coordinate.


Eligibility Criteria:
Inclusion Criteria:

healthy 18-40 years able to follow the protocol able to provide informed consent

Exclusion Criteria:

* Allergy to buprenorphine
* Mental illness
* Alcohol or drug abuse
* Chronic pain
* Daily use of analgesics
* Chronic medicinal treatment
* Treatment with corticosteroids
* Any use of medicine 48 hours before day of trial
* Smoker
* Blood donation within 3 months before day of trial
* Dementia
* Abnormal ECG
* Abnormal blood values:

Serum creatinine \> 100 umol/l Serum haemoglobin \< 8 mmol/L LDH \< 105 U/L or \> 255 U/L ASAT \> 45 U/L ALAT \> 70 U/L PP \< 0.9 INR or \> 1.1 INR Alkaline phosphatase \< 35 U/L or \> 275 U/L K+ \< 3,5 mmol/L or \> 5,0 mmol/L Na + \< 136 mmol/L or \> 146 mmol/
Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144

This open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144 (NCT02394028) and who meet eligibility criteria for enrollment into Part 1. In Part 2, participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 \[NCT02394028\]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.


Eligibility Criteria:
Inclusion Criteria:

Part 1 Open-Label Extension:

* Patients previously enrolled in etrolizumab Phase III study GA29144 (NCT02394028) who meet the eligibility criteria for open-label etrolizumab as described in the protocol

Part 2 Safety Monitoring:

* Patients who participated in etrolizumab Phase III study GA29144 (NCT02394028) and are not eligible or choose not to enter Part 1
* Patients who transfer from Part 1
* Completion of the 12-week safety follow-up period prior to entering

Exclusion Criteria:

Part 1 Open-Label Extension:

* Any new, significant, uncontrolled condition

Part 2 Safety Monitoring:

* No exclusion criteria
Open-Label Study of Oxycodone/APAP to Treat Post-Operative Pain Following Arthroscopic Knee Surgery

This is a pilot trial using this product in patients for the management of pain after outpatient arthroscopic knee surgery. This is an open-label study and the two active ingredients are well known pharmacologic entities.

The objective of this single center is to evaluate the safety and efficacy of Oxycodone Extended Release (MNK-795) in postoperative pain following common musculoskeletal surgical procedures. Knee surgery being the most common surgery performed in the US, the investigators chose the model. The investigators also want to look at the flexible-dosing and titration which is the common way pain managed by clinicians. This is an open-label study of MNK 795 to be described in the procedures section.

Primary endpoint:

• Change in pain from baseline (before taking the first dose of study medication) measured on NRS

Secondary endpoints:

* Patient/Investigator Global assessment of treatment satisfaction
* Safety evaluation with adverse event monitoring

Eligibility Criteria:
Inclusion Criteria:

1. Individuals aged 18-75 who underwent an orthopedic outpatient surgical procedure of their knee
2. Read and understand English and comprehend the procedures associated with participating in a clinical trial.
3. Signed an IRB approved consent form and HIPAA authorization
4. Patients with a pain intensity score of 4 or above on the 0-10 numerical rating scale (0 is no pain, 10 is the worst pain imaginable)

Exclusion Criteria:

1. Participants in any other clinical trial in the last 30 days or currently enrolled in a clinical trial
2. Allergy to Oxycodone or Acetaminophen.
3. Uncontrolled pain or other pain conditions that may interfere with evaluation
4. Pregnant women
5. Women who are trying to become pregnant
6. Women who are breastfeeding
7. Patient who is deemed to be medically unstable by the principal investigator
8. History of Alcohol, opioid or substance abuse in the last 2 yrs
9. History of sleep apnea that requires CPAP
10. History of serious respiratory illness
11. History of Gastric bypass
12. Prior use of opiates at doses higher than 90mg Morphine equivalent dosing
13. Will limit the study medication to 4 tab at each dosing and to total dose of 8 tab for 24 hrs. Subjects needing doses higher than that, based on their current opioid dose, will not be enrolled or discontinued
A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex

The purpose of this study is to see if adding stavudine (d4T) to anti-HIV drug regimens (with or without zidovudine, ZDV) can improve symptoms of AIDS Dementia Complex (ADC, problems involving the brain or spinal cord) in HIV-positive patients.

In this open-label, multicenter, multinational study, ZDV is replaced with d4T in ZDV-containing regimens, or d4T is added to non-ZDV-containing regimens in 20 patients experiencing ADC. Patients are defined as having failed treatment if they progress by one ADC stage on the MSK (Memorial Sloan Kettering) rating scale on study (i.e., from Stage 1 to 2 or Stage 2 to 3). Patients are evaluated on a weekly basis until the dementia deterioration is confirmed to be caused by HIV-1. The effect of d4T-containing regimens is assessed for the following parameters: neurological status, survival, AIDS-defining conditions, CSF (cerebrospinal fluid) and plasma viral load, CSF and blood immunological markers, blood CD4 cell counts, and viral resistance. This study also assesses the pharmacokinetics of d4T in the CSF and in the blood.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Are at least 13 years old (need consent if under 18).
* Have AIDS Dementia Complex.
* Have been on a stable anti-HIV drug regimen for at least 8 weeks prior to study entry.
* Agree to use effective methods of birth control during the study.
* Are available for at least 16 weeks of study.

Exclusion Criteria

You will not be eligible for this study if you:

* Have ever taken d4T.
* Have a neurological (brain/spinal cord) disease, such as chronic seizures or head injury, or certain other conditions that would interfere with your ability to complete the study.
* Are pregnant or breast-feeding.
* Abuse alcohol or drugs.
* Have peripheral neuropathy or a newly diagnosed AIDS-defining infection that requires treatment at the time of study enrollment.
* Have received certain medications.
* Cannot take medications by mouth.
* Have severe diarrhea for at least 7 days in a row within 30 days prior to study entry.
Endovascular Brachytherapy Combined With Stent Placement and TACE for HCC With Main Portal Vein Tumor Thrombus

It is a prospective and multi-center clinical research in China to compare the efficacy, safety and related impact factors between TACE alone and endovascular brachytherapy combined with stent placement and TACE for HCC with main portal vein tumor thrombus.

It is an open random prospective phase III clinical trial conducted by Principal Investigator Professor Zhi-ping Yan.Investigators in twenty-seven hospitals in China participate in.Patients with unresectable HCC with main portal vein tumor thrombus are enrolled. The investigators propose to recruitment 253 patients who are randomly assigned into the combined group (treated with endovascular brachytherapy combined with stent placement and TACE) and the control group (treated with TACE alone).There are 127 patients in combined group and 126 patients in control group. The criteria of inclusion and exclusion, and the methods of lab tests, imaging modality and treatment procedures are the same.

Eligibility Criteria:
Inclusion Criteria:

* (1) Hepatocellular carcinoma(HCC) diagnosis confirmed by needle biopsy or by two coincidental imaging techniques associated with increased α-fetoprotein according to the American Association for the Study of Liver Diseases (AASLD) guidelines;
* (2) According to the Barcelona Clinic Liver Cancer staging classification, HCC was unsuitable for resection, liver transplantation or percutaneous radiofrequency ablation;
* (3) Tumor thrombus, a low-attenuation intraluminal filling defect extending from intrahepatic portal vein branches adjacent to primary tumor into main portal vein, was confirmed by contrast-enhanced abdominal computer tomography (CT) or magnetic resonance imaging (MRI)
* (4) At least the first-order branch of the intrahepatic portal vein was patent in one lobe;
* (5) Child-Pugh classification grade A or B;
* (6) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less;

Exclusion Criteria:

* (1) Patients had a history of any therapy for HCC or portal vein tumor thrombus;
* (2) Advanced liver disease (bilirubin levels \>3 mg/dL, Aspartate transaminase or Alanine aminotransferase \>5 × upper limit of normal)；
* (3) Tumor invade the Inferior Vena Cava, extrahepatic spread;
* (4) Any contraindication to an arterial procedure such as impaired clotting tests (platelet count below 50 × 109/L or prothrombin activity below 50 %);
* (5) Renal failure,cardiac ejection fraction (\<50 %) or end-stage disease;
* (6) Patients who were not capable of cooperation during the procedure.
Study Evaluating OsseoSpeed™ Narrow Implant in the Upper and Lower Anterior Jaw

To evaluate 5-year survival, functionality and safety for OsseoSpeed™ 3.0 mm diameter implant when used for single tooth crown in positions 12, 22, 31, 32, 41 and 42. The primary hypothesis is that implant survival after 5 years is equal to what has been observed with comparable implants in current literature.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Aged 18-70 years at enrolment
* History of edentulism in the study area of at least two months
* Presence of natural tooth roots adjacent to the study implant position
* Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
* Deemed by the investigator as likely to present an initially stable implant situation

Exclusion Criteria:

* Unlikely to be able to comply with study procedures, as judged by the investigator
* Uncontrolled pathologic processes in the oral cavity
* Known or suspected current malignancy
* History of radiation therapy in the head and neck region
* History of chemotherapy within 5 years prior to surgery
* Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration, as deemed by the investigator
* Uncontrolled diabetes mellitus
* Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
* Smoking more than 10 cigarettes per day
* Present alcohol and/or drug abuse
* Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
* Previous enrolment in the present study
* Simultaneous participation in another clinical study, or participation in a clinical study during the last weeks prior to enrolment