cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of Individualized and Standardized Acupuncture Treatment for Low Back Pain

The purpose of this study is to determine whether acupuncture treatment(Individualized \& Standardized Acupuncture) is more effective than control (sham acupuncture or no treatment) and also whether individualized acupuncture is more effective than standardized acupuncture.

To determine whether individualized acupuncture is more effective than standardized acupuncture, 276 Low Back Pain patients will be recruited and randomly assigned to 4 separate groups.

Experimental groups(Individualized Acupuncture Group and Standardized Acupuncture Group) and Control groups (Sham acupuncture and waiting list)

The change of pain and physical functions will be compared among the four groups.

So the efficacy of acupuncture, and the best acupuncture treatment model will be determined. Also in addition, safety and abnormal reactions of acupuncture treatments will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients suffering Low Back Pain.
* Patients classified as Class 1(pain in the lumbar area, without radiation below the gluteal fold and in the absence of neurologic signs) or Class 2(Low back pain with radiation of pain not beyond the knee, no neurological signs) according to the Quebec Task Force System
* Suffering pain which is more than 40mm on VAS(Visual Analog Scale)
* Voluntary participants who have completed the consent.

Exclusion Criteria:

* Low back trauma history within 6 months.
* Low back surgery history within 6 months.
* Low back pain caused by malignancy, inflammatory disease, fibromyalgia, vertebral fracture, infection, juvenile scoliosis or congenital malformation.
* Pain in other parts of the body more severe than low back pain.
* Mental problems that can influence the pain or results of questionnaire.
* Diseases that can interfere absorption, metabolism and excretion of medicine.
* History of alcohol or drug abuse within 12 months of the study.
* Pregnant, breastfeeding or childbearing aged women who are not using any birth control methods.
Emergency Department Management of Sepsis Patients: A Goal-Oriented Non-Invasive Sepsis Trial

The purpose of this study is to determine whether the use of a 3-hour protocol utilizing non-invasive hemodynamic optimization treatment strategy results in better outcome and lower hospital costs in patients who present with severe bloodstream infections to the Emergency Department (ED).

Severe sepsis is a syndrome where the body develops organ dysfunction secondary to uncontrolled inflammatory response to infection. Various resuscitation bundles have been formulated and practised to treat severe sepsis, such as early goal-directed therapy (EGDT). EGDT involves the insertion of invasive catheters in patients with severe sepsis or septic shock using serial measurements to guide therapy and achieve hemodynamic goals, such as mean arterial pressure (MAP), central venous pressure (CVP) and central venous oxygen saturation (ScvO2) by 6 hours. The drawbacks include the invasive nature of inserting these catheters with its complications and tedium to set up the equipment. A non-invasive approach using the Non-Invasive Cardiac Output Monitor (NICOM) and passive leg raising (PLR) maneuver to guide fluid and vasoactive agent therapy targeting fluid responsiveness and MAP may be able to achieve better outcome, measured by lactate clearance at 3 hours and at a lower hospitalization cost.

Eligibility Criteria:
Inclusion Criteria:

* Fulfillment of at least 2 systemic inflammatory response syndrome (SIRS) criteria
* Suspected infection
* Serum lactate ≥3mmol/L

Exclusion Criteria:

* Age below 21 years
* Known pregnancy
* Prisoners
* Do-not-attempt resuscitation status
* Known severe aortic insufficiency or severe anatomic abnormalities of the thoracic aorta
* Primary diagnosis of trauma, burns, active seizures, acute cerebral vascular accident, acute coronary syndrome, status asthmaticus, major cardiac arrhythmias, active gastrointestinal haemorrhage, seizure or drug overdose
* Requirement for immediate surgery
* Inability to do PLR (e.g. ankylosis of hip joint, severe sciatica)
* Treating physician deems aggressive care unsuitable
* Those unable to give informed consent and unable to comply with study requirements
Added Value in Combined Use of Fusion Imaging and Contrast-enhanced Ultrasonography

So far, there have been studies showing that the CEUS-grafted technique has added value in biopsy and RFA, but no studies have compared the group using only fusion and the group using CEUS+fusion. Therefore, the additional added value of CEUS will be evaluated by comparing the two groups.

Despite the rapid development of tumor markers and liver imaging, pathological confirmation is still necessary for atypical liver lesions that do not meet imaging criteria. US guided procedures are widely used as a method to identify focal lesions of the liver pathologically, and these US guided procedures have no burden on the operation, can be easily accessed, and have a lower cost than surgery. However, the frequency of pathological confirmation with this US guided procedure remains at around 90%. In order to increase this probability, a technique for fusion of liver CT/MRI and US has been widely used in recent years, and this allows accurate targeting of small lesions through structures seen in CT and MR. Through the fusion technique, the biopsy success rate for focal lesions can be increased to 94.4%. However, there are many cases where lesions deeply located in patients with cirrhosis are invisible, and biopsy is difficult only with fusion due to poor sonic window in patients with high BMI. To this end, a technique called contrast-enhanced ultrasonography (CEUS), such as the fusion technique, was added, which is a technique that can identify tumor vascularity in real-time using second-generation contrast media. In recent studies, there are studies combining this fusion technique and CEUS technique, and the success rate of these techniques varies from 87.6% to 97.5%. Although CEUS with fusion techniques are theoretically superior to fusion only technique, the use of CEUS adds cost of contrast media and is limited in patients with side effects on contrast media. . Also, there is no study comparing the two so far, and this study intends to compare the technique combining CEUS and fusion and the technique using only fusion.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for ultrasound biopsy to confirm local liver lesions
* Adults over 18
* Patients who underwent multi-phasic liver CT or MRI within 6 weeks prior to the procedure
* Patients who understand and agree to the explanation and consent form and submit the consent form

Exclusion Criteria:

* Non-adaptive patients with ultrasound contrast agents (eg acute respiratory failure, heart disease, egg allergy, pregnant women, lactating women)
* Those who have difficulty obtaining proper liver ultrasound images A. Patient cooperation is not possible B. If it is difficult to obtain an image that is appropriate for the researcher's judgment (atrophy of the right lobe of the liver, a bowel is located between the liver and the abdominal wall, etc.)
Effectiveness of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure

This study was aimed at comparing the efficacy and safety of cutting balloons versus drug-coated balloons in treating venous segment stenosis of autologous arteriovenous fistulas.This is a prospective, multi-center cohort study.

The study will recruit 180 patients with venous segment stenosis of autologous arteriovenous fistulas at multiple centers from June 2024 to December 2025. Patients will be divided into two cohorts based on the treatment method: the Cutting Balloon group and the Drug-Coated Balloon group. The primary outcomes observed will be the primary patency rates of the target lesion at 1, 3, 6, and 12 months post-operation, re-intervention rates of the target vessel, and the technical success rates and procedural success rates of the two devices, along with major adverse events during the perioperative period.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged between 18 and 75 years.
2. Subjects possess a mature upper limb autologous arteriovenous fistula (AVF) and have undergone at least one hemodialysis session.
3. Target lesion must be located in the venous segment of the upper limb AVF.
4. Doppler ultrasound confirms that the target lesion stenosis is ≥50%, accompanied by at least one of the following clinical manifestations: elevated venous pressure during dialysis, abnormal fistula signs, significant reduction in blood flow (\<200ml/min).
5. Guidewire and balloon successfully pass through the lesion and complete dilation. 6.Subjects or their legal representatives must understand the purpose of the trial, voluntarily participate in the clinical trial, and sign an informed consent form, while also being willing to adhere to the specific follow-up schedules set by this trial.

Exclusion Criteria:

1. Target lesion located in the arterial segment or anastomosis of the AVF.
2. Target lesion located in the lower limb AVF.
3. Subjects with previous stent implantation in the AVF.
4. Patients diagnosed with symptomatic central venous occlusive disease: AVF flow reduction accompanied by swelling of the ipsilateral limb, chest, or facial area, with DSA confirmation of central venous occlusive disease.
5. Subjects with two or more target lesions in the AVF (when two stenoses are less than 3 cm apart, they are considered as one target lesion).
6. Subjects with acute thrombosis in the AVF or who have undergone AVF thrombolysis or thrombectomy within the past 30 days.
7. Subjects who have undergone or plan to undergo surgical intervention on the AVF within 30 days.
8. Subjects with AVF infection or concurrent systemic active infection.
9. Subjects planning renal transplantation or switching to peritoneal dialysis within the next 12 months.
10. Subjects with diseases causing coagulopathy, such as thrombocytopenic purpura.
11. Subjects undergoing immunotherapy or suspected/diagnosed with vasculitis.
12. Subjects with allergies or contraindications to heparin or contrast agents.
13. Subjects who are pregnant or breastfeeding.
14. Subjects with a life expectancy of less than 12 months.
Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye

In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD). Neovascular AMD is an eye disease that causes blurred vision or a blind spot due to abnormal blood vessels that leak fluid or blood into the light sensitive lining inside the eye (retina). The fluid buildup causes the central part of the retina (macula) responsible for sharp, straight-ahead vision to swell and thicken (edema), which distorts vision.


Eligibility Criteria:
Inclusion Criteria:

* Active subfoveal CNV secondary to nAMD, including juxtafoveal lesions that affect the fovea as assessed in the study eye.
* Total area of CNV (including both classic and occult components) must comprise greater than 50% of the total lesion area in the study eye.
* BCVA ETDRS letter score of 78 to 24 (corresponding to a Snellen equivalent of approximately 20/32 to 20/320) in the study eye.
* Decrease in BCVA determined to be primarily the result of nAMD in the study eye.
* Presence of IRF and/or SRF affecting the central subfield of the study eye on OCT.
* Contraceptive use by men or women should be consistent with local regulations regarding the methods of highly effective contraception for those participating in clinical studies.
* Other protocol-specified inclusion criteria.

Additional inclusion criteria for Year 3:

* At least one BCVA value and one central subfield retinal thickness (CST) value from measurements at one of the following visits: Visit 24 (Week 84), Visit 25 (Week 88) or Visit 26 (Week 92).
* Participant is enrolled at a site that participates in the extension period.

Exclusion Criteria:

* Causes of CNV other than nAMD in the study eye.
* Scar, fibrosis, or atrophy involving the central subfield in the study eye.
* Presence of retinal pigment epithelial tears or rips involving the central subfield in the study eye.
* Uncontrolled glaucoma (defined as IOP \>25 mmHg despite treatment with anti-glaucoma medication) in the study eye.
* History of idiopathic or autoimmune uveitis in the study eye.
* Myopia of a spherical equivalent of at least 8 diopters in the study eye prior to any refractive or cataract surgery.
* History or clinical evidence of diabetic retinopathy, diabetic macular edema, or any retinal vascular disease other than nAMD in either eye.
* Evidence of extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening/randomization.
* Uncontrolled blood pressure (defined as systolic \>160 mmHg or diastolic \>95 mmHg).
* Any prior or concomitant ocular (in the study eye) or systemic treatment (with an investigational or approved, anti-VEGF or other agent) or surgery for nAMD, except dietary supplements or vitamins.
* Other protocol-specified exclusion criteria
Study Evaluating Effexor XR in Elderly Patients With Major Depression.

Phase III study evaluating Effexor XR in elderly patients with major depression.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with major depression based on DSM-IV-TR
* Patients having minimal total score of 18 on the HAM-D17 and minimal score of 2 on the item of "depressed mood" of HAM-D at baseline

Exclusion Criteria:

* Patients with schizophrenia or any other psychotic disorder
* Patients with history or presence of bipolar disorder
Rapid Non-Invasive Brain Stimulation for Hoarding Disorder

This study explores whether rapid non-invasive brain stimulation can help reduce hoarding disorder symptoms.

Hoarding disorder (HD) is characterized by difficulty letting go of possessions, leading to clutter that congests living spaces and impairs daily functioning. The majority of HD patients treated with cognitive behavioral therapy for HD usually experience considerable residual symptoms. New treatments are greatly needed. This study explores whether rapid non-invasive brain stimulation can help reduce hoarding disorder symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years
2. Primary diagnosis of hoarding disorder
3. Sufficient severity of hoarding symptoms
4. Willing and able to understand and complete consent and study procedures

Exclusion Criteria:

1. Psychiatric or medical conditions or medications that make participation unsafe
2. Pregnant or nursing females
3. Previous exposure to TMS or ECT
4. History of any implanted device or psychosurgery
Habitual Hypertension Medication Adherence in Arizona

This research will implement a novel habit formation intervention among people living with hypertension and an indication of medication non-adherence to help maintain high anti-hypertensive (AH) medication adherence by leveraging the power of routines and unconsciously triggered habitual behaviors. The investigators will test whether high AH medication adherence can be maintained using contextually-cued medication adherence habits that mitigate the negative effects of declining motivation, forgetfulness, and the cognitive burden of performing repeated daily behaviors. The use of mHealth tools will help to make this a scalable and sustainable intervention approach for addressing an important healthcare issue in Arizona.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years old or older
* Currently diagnosed with hypertension (either stage I or stage II hypertension)
* Able to read/write/understand English
* Have daily access to a smartphone
* Engaged in hypertension care (i.e., already been prescribed antihypertensive medication for a minimum of 12 months at the time of study enrollment)
* Demonstrated antihypertensive medication nonadherence by having over 73 days without documented antihypertensive medication prescription coverage (observable in Arizona Health Care Cost Containment System (AHCCCS) prescription drugs claims) in the past 12 months (i.e., \>80% mean adherence)

Exclusion Criteria:

* Less than 18 years old
* Does not have current hypertension diagnosis
* Unable to read/write/understand English
* Does not have daily access to a smartphone
* Not currently engaged in hypertension care
* Has not demonstrated antihypertensive medication nonadherence within the past 12 months
A Novel Adaptive Anastomotic Technique for Left-sided Colonic Resection

The goal of this pilot clinical trial is provide preminary evidence of the effectiveness of the C-REX device, developed by CarpoNovum AB, in preventing anastomotic leak and improving anastomosis healing after sigmoid or high rectal resection in patients with colon neoplasia. The primary aim of the study is to evaluate the rate of anastomotic leak in patients receiving the study device within 90 days from the surgical procedure.

Despite technological advancements, the rate of anastomotic leak after left colon and high rectal resection remains high, around 20%. The device C-REX, developed by CarpoNovum, may help the anastomosis construction and promote its healing. This may lead to reduced anastomotic leak rate and severity. This study aims to collect preliminary evidence on the effectiveness of C-REX to develop a future larger multicentric trial. This pilot study will collect preliminary data on the rate and severity of 90-day anastomotic leak in patients receiving the C-REX device.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged equal or more than 18 years old, both men and women.
* Patients with a proven diagnosis of sigmoid colon or high rectal tumors requiring anterior rectal resection as procedure of choice (colorectal cancer or benign polyps), as confirmed by radiological and histological exams.
* Patient indicated to minimally invasive or open sigmoid or high rectal resection.

Exclusion Criteria:

* Patients with pre-existing health conditions requiring surgery, such as intestinal obstruction or perforation, local or systemic infections, peritonitis, or intestinal ischemia. Patients with intraoperative evidence of any of these conditions will be withdrawn from the study.
* Patients with preoperative evidence of distal metastasis. Patients with intraoperative evidence of distal metastasis or peritoneal carcinosis will be withdrawn from the study.
* Patients with documented intestinal or anal stenosis or other obstructions distal to the anastomosis. Patients with intraoperative evidence of intestinal or anal stenosis will be withdrawn from the study.
* Patients who received radiation therapy to organs in abdomen or pelvis unrelated to current colorectal condition.
* Patients who are unable or received contraindication for the preoperative mechanical preparation. Patients with a preoperative evidence or suspicion of incomplete colon cleansing will be withdrawn from the study.
* Patients indicated to defunctioning stoma. Patients requiring diverting stoma as for intraoperative indication will be withdrawn from the study.
* Patients with an anastomosis in rectum below the peritoneal reflection and/or another procedure of choice than high anterior resection.
* Any condition that, in the opinion of the investigator, may interfere with the study conduction. In particular, any condition which can cause significant alteration of colonic wall thickness such as chronic and repeated infection which may impair the use of C-REX.
The Effect of Entonox on Stages of Labor in Nulliparous Women

This Trial study about The effect of Entonox associated with duration of labor in Active phase and efficacy for relief pain of labor .So investigators start to study up to 14 months

Investigators will enroll participants in 2 groups by randomized . First group will inhale Entonox and the second group not receive any gas . The participants in Entonox group will inhale gas in 4-5 times for each uterine contraction and Nurse will measure blood pressure , O2 saturation ,pain score before use gas . The outcome,investigators study about Apgar score , duration of labor , pain relief in both group,route of delivery and estimated blood loss

Eligibility Criteria:
Inclusion Criteria:

* Nulliparity
* Age 18 years old or more
* Gestational age 37-40+6 wks
* Singleton
* Cephalic presentation
* Cervical dilatation \> 5 cm
* Estimated fetal weight 2,500-4,000 gm

Exclusion Criteria:

* Estimated fetal weight more than 4,000 gm
* High risk pregnancy (Hypertension in pregnancy ,Endocrine disorder , autoimmune disorder , epilsepsy etc)
* SpO2 \< 95 %
* Contraindication for Entonox usage ( Severe head injury , asthma , Pulmonary disease,Otitis media )
* Drug allergy : Metoclopramide , Dimenhydrinate , Pethidine ,Entonox
Fluoroquinolone Associated Disability

The purpose of this study is to: 1) describe drug utilization for Fluoroquinolone(FQ), Azithromycin (AZ) and Sulfamethoxazole/Trimethoprim(ST) in the entire Truven MarketScan Commercial Claims and Encounters database (CCAE) database, and specifically among individuals in the Health and Productivity Management (HPM) during the observation period; 2) describe the rate of disability associated with 2 or more System Organ Class adverse events (SOC AEs) and exposure to FQs for several acute, uncomplicated indications; and 3) compare the rates of disability for 2 or more SOC AEs and exposure to FQs and AZ/ST for the same indications.


Eligibility Criteria:
Inclusion Criteria:

* Participants in the Truven CCAE database who were eligible for disability insurance and can be linked to the Truven Health and Productivity Management (HPM) database
* Study participants will be included if they have 6 months of history before the first day on FQ or AZ/ST and at least 120 days afterward

Exclusion Criteria:

* If any protocol specified medical conditions or exposure to the protocol specified medications in the 6 months preceding the first qualifying dose of FQ or AZ/ST
* If participants have any disability claim in the 6 months preceding the qualifying FQ or AZ/ST dose
* If participants have the protocol specified condition-specific diagnoses within the 3 months preceding the qualifying FQ or AZ/ST exposure