cyrilzakka/clinical-trials huggingface dataset:
Back Pain Response to Different Acupuncture Methods

Acupuncture has been used for many years to help relieve pain. However, it is not clear how acupuncture works. We are doing this study to learn about the effects of different forms of acupuncture on chronic low back pain. We are interested in learning about brain activity during pain. We plan to look at brain activity at the beginning and the end of the study, after 6 sessions of acupuncture.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers 18-60 years of age.
* Meet the Classification Criteria of the chronic LBP (having low back pain for more than 6 months), as determined by the referring physician.
* At least 4/10 clinical pain on the 11-point LBP intensity scale.
* Patients must be able to provoke or exacerbate their chronic LBP using our calibrated exercise-like maneuver.
* Must have had a prior evaluation of their low back pain by a health care provider, which may have included radiographic studies. Documentation of this evaluation will be sought from Partners or outside medical records and kept in the subject's research record.
* At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.

Exclusion Criteria:

* Specific causes of back pain (e.g. cancer, fractures, spinal stenosis, infections),
* Complicated back problems (e.g. prior back surgery, medicolegal issues),
* Possible contraindications for acupuncture (e.g. coagulation disorders, cardiac pacemakers, pregnancy, seizure disorder), and conditions that might confound acupuncture intervention effects or interpretation of results (e.g. severe fibromyalgia, rheumatoid arthritis).
* Conditions making acupuncture difficult (e.g. paralysis, psychoses),
* Prior acupuncture treatment for back pain; 1 year wait for any other type.
* The intent to undergo surgery during the time of involvement in the study.
* History of cardiac, respiratory, or nervous system disease that, in Dr. Wasan's judgment, precludes participation in the study because of a heightened potential for adverse outcome. For example: asthma or claustrophobia.
* Presence of any contraindications to MRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.
* Involvement in workmen's compensation or disability claims.
* Radicular pain extending below the knee.
* Active substance abuse disorders within the last 24 months, based on subject self-report.
* Use of more than 60 mg morphine equivalent prescription opioids or steroids for pain.
Intraoperative Superior Hypogastric Plexus Block For Pain Relief During Cesarean-Section

PURPOSE: to evaluate the efficacy of superior hypogastric plexus block for pain relief after cesarean section

Superior hypogastric plexus block(SHPB) for pain relief is routinely implemented in cesarean section operations at H.S.U Kocaeli Derince Education and Research Hospital. The implementation of this procedure depends on the clinical situation of the patient, the preference of the surgeon and the anesthesiologist, the course of the operation, and whether the patient wishes or not. Superior hypogastric plexus block is performed with 0.25 % bupivacaine 30 ml injected under peritoneum above promontorium.

This is a prospective case-control study. The sample consisted of 60 women having cesarean-section with general anesthesia at H.S.U Kocaeli Derince Education and Research Hospital divided into two groups: the first group having superior hypogastric plexus block for pain relief and the control group not having superior hypogastric plexus block. All participants signed an informed consent and the study was approved by the Ethics Committee of Kocaeli University ( KUGOKAEK 2017/270). The sample size was calculated with G Power 3.1 program. With ki-square Goodness-of-fit test α:0.05 ,power 95% ,effect size 0.5 total sample size was calculated 52, including 26 in case group and 26 in control group. Women having cesarean-section with spinal anesthesia, women with known bupivacaine allergy, women with anxiety-depression disorder, women with known fibromyalgia were not enrolled to the study. Age, BMI(body mass index), education status, VAS (visual analog scale) scores ,the amount of analgesic used and the hour of gas extraction and bowel movement will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women having cesarean-section operation at H.S.U Kocaeli Derince Education and Research Hospital with general anesthesia,
* Women agree to participate in the study,
* Literate women.

Exclusion Criteria:

* Women having cesarean-section with spinal anesthesia,
* Women with known bupivacaine and NSAIDS allergy,
* Women with anxiety-depression disorder,
* Women with known fibromyalgia.
* Insufficient ability to understand information in Turkish
Closure of Skin Incision Using CO2 Laser

The purpose of this study is to evaluate the safety and effectiveness of using Temperature Controlled Laser Soldering System for soft tissue bonding.

Skin incisions can be closed by a variety of method which create temporary approximation of the wound edges until natural healing process ensue and reach a phase, where it is closed and can sustain the daily tensile forces.

The wound closure devices include sutures, staples, tapes, tissue adhesives. The Applied Physics group at the Tel Aviv University has developed a Temperature Controlled CO2 Laser Soldering system for soft tissue bonding.

This system includes features that make laser soldering suitable for clinical use. The Temperature Controlled Laser Soldering System is composed of CO2 fiberoptic laser device, Infrared fiber-optic radiometer, a computerized temperature control program, propriety grip device (Clamps) and concentrated Human Albumin as a soldering agent.

Eligibility Criteria:
Inclusion Criteria:

* Male/Female age 18-65.
* Subject is scheduled for laparoscopic cholecystectomy surgery.
* Subject able to comprehend and sign informed consent for participation in this study.
* Ability to comply with the study procedures and follow-up visits

Exclusion Criteria:

* Subject has a history of hypertrophic or keloid scar formation
* Subject is a pregnant and/or nursing woman
* Subject has a known allergy to blood products
* Subject is suffering from a bleeding disorders or using anticoagulant medications
* Subject is suffering from hepatic or renal disorder
* Subject is suffering from rheumatic and / or collagen disorder
* Subject is using steroids
* Subject is suffering from immunosuppressive disorder
* Subject is suffering from Ischemic Heart Disease (IHD)
* Subject is suffering from neoplastic disorder
* Subject who has had an active illness within 4 weeks of study enrollment
* Subject is participating in another study for an investigational drug and/or device within 3 months of study enrollment
* Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study.
Treatment Outcomes in Bile Duct Stones

This registry is to evaluate the procedural and clinical outcomes in patients undergoing endoscopic treatment of bile duct stones when utilizing an algorithmic management approach.

Gallstone diseases are common, affecting 20 million patients in the United States with associated costs of over US $6 billion. Common bile duct (CBD) stones in turn occur in 15-20% patients with gallstone disease and require treatment due to risk of infection and pancreatitis. Endoscopic treatment via endoscopic retrograde cholangiopancreatography (ERCP) is the treatment modality of choice in CBD stones. The most simple treatment techniques include biliary sphincterotomy and stone extraction via the use of standard devices such as a stone retrieval balloons or stone retrieval baskets. However, patients with difficult bile duct stones require advanced maneuvers namely mechanical lithotripsy, large balloon sphincteroplasty (LBS) of the major duodenal papilla and single operator cholangioscopy-guided lithotripsy (SOC-LL).

Currently, there are no standardized treatment approaches in the management of CBD stones, especially in the management of difficult CBD stones. Therefore, ERCP in patients with difficult CBD stones can be inefficient and prolonged with use of multiple devices and techniques. In an effort to standardize the management of bile duct stones, we have devised an algorithm for the treatment of bile duct stones using current standard of care methods, taking into account the size of bile duct stones, size of bile duct and availability of endoscopic expertise. The objective of this registry is to evaluate the procedural and clinical outcomes in patients undergoing endoscopic treatment of bile duct stones when utilizing an algorithmic management approach.

Eligibility Criteria:
Inclusion Criteria:

1. All patients with confirmed or suspected bile duct stones undergoing endoscopic therapy for treatment of bile duct stones
2. Patients 18 years or over

Exclusion Criteria:

1. Patients not undergoing endoscopic therapy for bile duct stones
2. Patients \< 18 years of age
Risk-guided Disease managEment Plan to prevEnt CAD in Patients Treated With Previous Cancer

REDEEM-CAD is a prospective multi-centre study of CAD risk evaluation and management in cancer survivors 40-70 years with chemotherapy or radiotherapy \>5 years ago.

REDEEM-CAD is a prospective multi-centre study in which a process of evaluating the risk of coronary artery disease is studied in cancer survivors 40-70 years with chemotherapy or radiotherapy \>5 years ago. The efficacy of this CAD risk evaluation will be compared with the broad community in two existing studies - CAUGHT-CAD and EDCAD. This unique Screening/Management Plan (SMP) has 2 components; 1) A novel clinical and imaging-based screening algorithm to select those most likely to develop coronary artery disease, 2) A clinical review to ensure optimal risk factor control and cardio protection.

Follow-up of treated patients will continue for an average of 36 months, with clinic reviews at 12, 24 and 36 months. The results will define the prevalence of subclinical coronary artery disease, and the feasibility and the efficacy of the SMP.

Eligibility Criteria:
Inclusion Criteria:

A history of cancer \>5 y ago associated with potential cardiotoxicity from chemotherapy and/or radiotherapy (chiefly survivors of breast cancer, Hodgkin's lymphoma and prostate cancer).

Exclusion Criteria:

* Unable to provide written informed consent to participate in this study
* Known coronary artery disease at recruitment
* History of previous coronary artery disease
* Inability to acquire interpretable CT images
* Contraindications/Intolerance to or already taking statin therapy
* Oncologic (or other) life expectancy \<12 months or any other medical condition (including pregnancy) that results in the belief (deemed by the Chief Investigators) that it is not appropriate for the patient to participate in this trial
Chronic Lymphocytic Leukemia Responds to Dermal Chelation

The purpose of this clinical trial is to identify 50 participants with Chronic Lymphocytic Leukemia (CLL) and follow their total white blood cell (WBC) counts and absolute lymphocyte counts after performing dermal chelation and administering nutritional therapy

The purpose of this clinical trial is to use dermal chelation and hair tissue analysis to identify 50 participants with CLL. The total wbc counts and absolute lymphocyte counts of these participants will be followed after serial dermal chelations and nutritional therapy.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Chronic Lymphocytic Leukemia and has a toxic heavy metal load
* Toxic heavy metal load

Exclusion Criteria:

* Pregnant
* Pacemaker implants
* Organ transplant recipients
* Psychotic episodes or epileptic seizures
A Study of TMC207 in Patients With Moderately Impaired Hepatic Function

The purpose of this study is to assess the pharmacokinetics (what the body does to the medication), safety and tolerability of TMC207 and its N-monodesmethyl metabolite (M2) in healthy participants and in patients with moderate hepatic impairment after administration of a single 400 mg dose of TMC207.

This is a Phase I, open label (all people know the identity of the intervention) study of TMC207. The study consists of a screening period and a 4-weeks treatment period. Sixteen participants will be enrolled in two panels. Panel A will include 8 patients of moderate hepatic impairment and Panel B will include 8 healthy participants. Safety evaluations including adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination will be monitored throughout the study. The entire study duration for each participant will be approximately 7 weeks.

Eligibility Criteria:
Inclusion Criteria:

* For healthy participant Panel A: Healthy on the basis of physical examination, medical history, vital signs, electrocardiogram and clinical laboratory tests performed at screening
* Should match to a patient with hepatic impairment with regards to sex, age (more or less to 5 years), and body mass index
* For patients in Panel B with moderate hepatic impairment: history of hepatic disease, documented liver cirrhosis and moderate liver function impairment defined by the Child-Pugh classification

Exclusion Criteria:

* A positive tuberculin skin test indicating latent tuberculosis
* A positive human immunodeficiency virus (HIV)-1 or HIV-2 test at screening
* Moderate hepatic impairment patients with acute hepatitis, Hepatic carcinoma, Grade 3 or 4 encephalopathy, or active candidate for liver transplantation
* Matched healthy participants with current active hepatic disease
Effects of Serotonin Agonist Citalopram on Multimodal Esophageal Stimulation in Healthy Volunteers

To investigate the effect of citalopram, a selective serotonin reuptake inhibitor, on esophageal sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* HV aged between 18 - 60 years

Exclusion Criteria:

* history of psychiatric disease or a positive first degree psychiatric family history
* pregnancy or lactation
* concomitant administration of any centrally activating medication (anti-depressive medication, hypnotics, sedatives, anxiolytics, ...)
* medication affecting esophageal motility
* significant co-morbidities (neuromuscular, psychiatric, cardiovascular, pulmonary, endocrine, autoimmune, renal and hepatic)
* prior history of esophageal, gastric surgery or endoscopic anti-reflux procedure
* history of gastrointestinal disease
MRI Parenchymal Enhancement: A New Marker of Breast Cancer Risk

The purpose of this study is to learn about how a woman's health history influences what a normal breast looks like on an MRI. The investigators also want to learn about how the amount of different natural hormones a woman has affects how the breast looks on an MRI. The investigator's hope is that this will help to find women at a high-risk of breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* age 21 years or older
* be a cancer-free pre- or postmenopausal woman
* have no prior personal history of any cancer (including DCIS, excluding nonmelanoma skin-cancer)
* able to speak and read English because the questionnaire is only available in English
* able to provide informed consent

Exclusion Criteria:

* are pregnant at the time of MRI
* have a prior personal history of any cancer (including DCIS, excluding nonmelanoma skin cancer)
Construction of the "Patient-Centered"Molecular Pathology Diagnostic Center

The investigators want to achieve the goal of diagnosis in early phase, accurate treatment and existence for a long period in order to screen in early phase, diagnose in clinical trial, choose treatment and evaluate prognosis of cancers by establishing molecular pathology tools.

This research is going to discuss the biomarker expression of common malignant neoplasm (tumor)among Taiwanese, such as large intestine rectal cancer, breast cancer, prostate gland cancer, lung cancer, oral cancer, gastric cancer, liver cancer, cervical cancer, cancer of the womb, ovarian cancer, carcinoma of urinary bladder, kidney cancer and so on.

The investigators hope to find the biomarker of common tumors among Taiwanese in order to develop the tools of tumor screening, diagnosis, treatment methods and prediction prognosis

Eligibility Criteria:
Inclusion Criteria:

* above 20 years old
* all kinds of cancer patients

Exclusion Criteria:

* under 20 years old
* none cancer patients
A Preliminary Exploratory Study to Evaluate the Safety and Immunogenicity of Omicron Variant Bivalent Vaccine V-01-B5

It is a single center, randomized, open-labeled, exploratory clinical study to evaluate the safety and immunogenicity of Recombinant SARS-CoV-2 Fusion Protein bivalent Vaccine V-01-B5 as a second booster in adults aged 18-59 years after vaccinated with 3-dose of inactivated vaccines.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 -59 years old at time of consent, male or female;
* Normal body temperature;
* Participants who have completed 3-dose regimen of inactive vaccination (CoronaVac) against SARS-CoV-2 wild type in the past 5-9 months;
* Female participants who are not pregnant at the time of enrollment (urine pregnancy test is negative), nor during lactating; and has no birth plan and agree to take effective contraception in 7 months after enrollment; and took effective and acceptable contraceptive methods in the previous 2 weeks before the enrollment;
* Be able and willing to complete the study during the entire study and follow-up period;
* Participants who have the ability to understand the study process, sign the informed consent form voluntarily , and be able to comply with the requirements of the clinical study protocol.

Exclusion Criteria:

* Serious chronic diseases or uncontrolled diseases;
* Uncontrolled neurological disorders, epilepsy;
* Received any inactivated vaccine within 1 week or received any attenuated vaccines within 4 weeks;
* Patients with congenital or acquired immunodeficiency;
* History of severe allergy or be allergic to any components of the test vaccines;
* History of hereditary hemorrhagic tendency or coagulation dysfunction;
* Patients with malignant tumors and other patients have a life expectancy less than 1 year;
* Refuse to sign the informed consent form or inability to complete follow-ups as required by the protocol;
* History of previous COVID-19 infection;
* Pregnant or breastfeeding women, or females of childbearing potential who not agree to or able to take effective and acceptable contraceptive methods during the study;
* Participants who have participated in other clinical trials within 3 months or are participating in other clinical trials;
* Those considered by the investigator as inappropriate to participate in the study.
Early Warning System for Clinical Deterioration on General Hospital Wards

The goal is to develop a two-tiered monitoring system to improve the care of patients at risk for clinical deterioration on general hospital wards (GHWs) at Barnes-Jewish Hospital (BJH). The investigators hypothesize that the use of an automated early warning system (EWS) that identifies patients at risk of clinical deterioration, with notification of nurses on the GHWs when patients are identified, will reduce the risk of ICU transfer or death within 24 hrs of an alert. As a substudy, the investigators will pilot the use of a wireless pulse oximeter to establish feasibility and to develop algorithms for a real-time event detection system (RDS) in these high-risk patients.


Eligibility Criteria:
Inclusion Criteria:

* All patients age 18 and above, hospitalized in GHWs at Barnes Jewish Hospital.

Exclusion Criteria:

* Minors, patients younger than 18 years old.
Multivessel TALENT

Multivessel TALENT is a prospective, randomized, multi-center study comparing clinical outcomes between SUPRAFLEX Cruz and SYNERGY in approximately 1550 patients with de-novo three vessel disease undergoing percutaneous coronary intervention (PCI). Patients will be treated according to "state of art PCI"; not only treatment strategies based on the latest ESC guideline, such as SYNTAX Score II recommendation, Heart Team discussion, post-procedure intravascular imaging optimization, cholesterol reduction by statin or PCSK-9 inhibitor, but also exploratory treatment strategies based on the latest evidence, such as physiological assessment using quantitative flow ratio and prasugrel monotherapy following 1-month dual antiplatelet therapy after PCI.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients' ≥18 years.
2. At least 1 stenosis (angiographic, visually determined de novo lesions with ≥50% DS) in all 3 major epicardial territories (LAD and/or side branch, LCX and/or side branch, RCA and/or side branch) supplying viable myocardium without left main involvement.
3. The vessel should have a reference vessel diameter ranging from ≥2.25 mm to ≤4.50 mm (no limitation on the number of treated lesions, vessels, or lesion length).
4. Patients with chronic coronary syndrome or stabilized acute coronary syndromes.
5. All anatomical SYNTAX Scores are eligible for initial screening with the SYNTAX Score II, provided that the SYNTAX Score II recommends equipoise risk (PCI or CABG) or PCI only.
6. Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee and is willing to comply with all protocol-required evaluations.
7. Agree with conditional longer follow up from 2 to 5 years with one phone contact yearly.

Exclusion Criteria:

1. Under the age of 18.
2. Unable to give informed consent.
3. Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice).
4. Known contraindication to medications such as Aspirin, Heparin, Bivalirudin, Prasugrel and Ticagrelor.
5. Prior PCI or prior CABG.
6. Ongoing ST-elevation myocardial infarction (STEMI).
7. Cardiogenic shock is also an exclusion criteria.
8. Concurrent medical condition with a life expectancy of less than 2 years.
9. Currently participating in another trial and not yet at its primary endpoint.
10. Patient with both ostial LAD and ostial LCX stenosis, or left main stenosis.
11. Previous intracranial haemorrhage.
Evaluation of The Effect of Fertility Support Education Given to Infertile Couples

The aim of the this study was to evaluate the effect of fertility support education given to infertile couples before treatment.

Before the treatment, couples were given fertility support training for four weeks. After the treatment was completed, the couples' stress level and quality of life, women's self-efficacy, fertility readiness, cortisol levels and pregnancy outcomes were examined.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with primary infertility
* have not received fertility support training before
* can speak Turkish

Exclusion Criteria:

* with psychiatric illness