cyrilzakka/clinical-trials huggingface dataset:
Acupuncture in Chronic Migraine: A Randomized Controlled Trial

The aim of this study was to investigate the efficacy and tolerance of acupuncture treatment compared with pharmacologic treatment in patients with chronic migraines.Besides, the investigators tested whether the clinical effects of acupuncture in chronic migraine prophylaxis are mediated by changes of the plasma CGRP (Calcitonin gene-related peptide).

Subjects who completed the prospective baseline periods and meet met the prespecified entry criteria will be randomized into 2 groups: acupuncture treatment, and topiramate treatment group.

Subjects will be allowed to continue taking acute migraine medications for the treatment of breakthrough attacks during the trial, but any migraine preventive medications will be prohibited.

Written informed consent was obtained from all participants before entering the study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75 years old
* Patients were required to have a diagnosis of chronic migraine with or without medication overuse that satisfied the ICHD-2 criteria during the last 3 months prior to trial entry, with an established migraine history for at least 1 year.

Exclusion Criteria:

* Patients did not fulfill the criteria of ≧ 15 days or response to triptans or ergots on at least 8 days in prospective baseline periods .
* The presence of headaches other than chronic migraine (such as another primary chronic headache or any secondary headache).
* Migraine prophylaxis agents during last 3 months including β-blockers, anti-depressants, calcium channel blockers, anti-epileptic agents or cycle-modulating hormonal drugs.
* Migraine onset after age 50 or the age at onset of CM \> 60 years.
* History of hepatic disorder, nephrolithiasis or other severe illness.
* Cognitive impairment interfering with the subject's ability to follow instructions and describe symptoms.
* Prior fearful experience of acupuncture.
* Bleeding diathesis or anticoagulation.
* Pregnant or nursing.
Neurologic Function Post Intubation

The frequency of oxygen desaturation during emergency intubation is not uncommon. However, the significance and clinical sequalae of hypoxia during emergency intubation in critically ill, non-trauma patients is not known. Therefore, the aim of this study is to evaluate neurologic function post-intubation of critically ill, non-trauma patients. Providing knowledge on whether the degree of hypoxia during emergency intubation is associated with worse neurologic outcomes, will guide clinical practice to ameliorate that level of hypoxia

Critically ill patients undergoing emergent endotracheal intubation are at risk for oxygen desaturation in a variety of acute care settings. Such complication could arise from patient, operator, or procedure related factors. Evidence suggests that rapid sequence intubation (RSI) improves first-pass success and reduces complications in the critically ill. Nonetheless, the procedure is not without risks. In fact, emergency intubation is associated a reported oxygen desaturation rate of 10.9% - 33.5%. High quality pre-oxygenation has been shown to prolong time to desaturation during emergency airway management. Despite advances preoxygenation techniques, a significant number of patients undergoing emergency intubation still experience desaturation. Most of the time this is transient and easily reversible. Occasionally however, desaturation becomes critical and may result in devastating complications such as dysrhythmias or cardiopulmonary arrest.

The brain consumes a significant amount of energy and is exquisitely sensitive to hypoxia and hypoperfusion. Hypoxic brain injury occurs whenever oxygen delivery to the brain is compromised. The role of secondary brain insults including hypoxia and hypotension, in traumatic brain injury (TBI) is well established. Previous literature has demonstrated that a single event of hypoxemia in a head-injured patient substantially increases morbidity and mortality. This has resulted in airway management being a cornerstone in the care of unconscious TBI patients, to ensure adequate oxygen delivery to the injured brain. However, the significance and clinical sequalae of hypoxia during emergency intubation in critically ill, non-trauma patients is not known. Therefore, the aim of this study is to evaluate neurologic function post-intubation of critically ill, non-trauma patients.

Eligibility Criteria:
Inclusion Criteria:

* Good baseline neurologic function (Modified Rankin Scale: 1-3)
* Emergency departments
* Critical care units
* In-patient floors
* Patients undergoing emergent intubations as determined by the treating physician
* Age\> 17 years old
* Good baseline modified rankin scale (mRs 1-3)

Exclusion Criteria:

* Pediatric patients (17 years of age of less)
* Pregnant patients
* Intubations occurring in the operating room
* Prisoners
* Trauma
* Status epilepticus
* Primary intracranial pathology
* Cardiopulmonary arrest
* Poor baseline neurologic function (Modified Rankin Scale: 4-5)
* Pre-Hospital Intubation
a Modified NTU-HELP Program

The aim is to replicate, develop, and pilot test a model of care for the prevention and management of functional decline of older patients during hospitalization.

to develop an intervention protocol that achieves clinical development objectives in a scientifically rigorous and time efficient manner.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 year and older
* Length of Stay is over 6 days
* Able to communicate verbally or in writing

Exclusion Criteria:

* Coma
* Mechanism ventilation
* Aphasia, if communication ability is severely impaired
* Terminal condition with comfort care only, death imminent
* Combative or dangerous behavior
* Severe psychotic disorder that prevents patient from participating in interventions
* Severe dementia (e.g. unable to communicate; MMSE=0). For patients with severe impairment (e.g. MMSE\<10), decision to enroll will be made on a case-by-case basis depending on their ability to participate in intervention.
* Respiratory isolation (e.g. tuberculosis). Patients on contact isolation (e.g. vancomycin-resistant enterococcus) or droplet precautions will be enrolled.
* Discharge firmly anticipated within 6 days of admission. Enroll if discharge date unsure
* Refusal by patient or family member.
* Others. Reason to be well documented.
Saline Versus Balanced Crystalloid in Traumatic Brain Injury

The goal of this clinical trial is to determine which crystalloid (saline or balanced) should be used in the critical management of Traumatic Brain Injury (TBI) in moderate or severe TBI patients. This trial will determine whether the use of saline or balanced crystalloids is associated with improved outcomes in TBI patients.

Participants will

1. be given fluids through the veins, either saline or balanced fluid will be given.
2. From the first day to the day 14 of the hospitalization (or discharge, whichever comes first), vital signs, laboratory values, treatments given, and other medical data will be collected from the medical record.
3. Six months later, your final disability, if any, will be assessed during your follow-up with a doctor. It involves answering a short survey that will take about 5 minutes or less.


Eligibility Criteria:
Inclusion Criteria:

* Trauma patients presenting to the Emergency Room for initial care
* Glasgow Coma Scale ≤ 12
* Head CT with skull fracture(s) and/or hemorrhage(s) (\>1cm in any single dimension) with a reported mechanism of trauma

Exclusion Criteria:

* Severe visceral trauma dictating mortality (visceral injury severity score \> brain injury severity score)
* Non-survivable brain injury based on the treating physician's judgment
* Emergent visceral operative intervention before complete trauma assessment
* Concern for ruptured intracranial vascular malformation
* Patients who are transferred from another facility
Angiogenesis Inhibitor Plus Anti-PD-1/PD-L1 Antibody in Advanced Esophageal Cancer

The combination of an anti-PD-1/PD-L1 antibody with an angiogenesis inhibitor has shown efficacy in many cancers.The purpose of this study is to confirm that the combination of these two drugs can benefit patients with advanced esophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Esophageal cancer confirmed by histopathology or cytology
2. Unresectable locally advanced/recurrent or metastatic esophageal cancer, or progression after neoadjuvant or adjuvant therapy
3. Esophageal cancer patients who benefit from the use of an anti-PD-1/PD-L1 antibody with an angiogenesis inhibitor evaluated by the researchers
4. Patients who sign informed consent and voluntarily join the study

Exclusion Criteria:

1. Patients who are recommended not using an anti-PD-1/PD-L1 antibody or an angiogenesis inhibitor in the instructions, or other patients who are judged by the investigators to be unsuitable in the study
2. Patients who are undergoing treatment regimen of blind trial
Sternotomy PIFB Block in Open Heart Surgery

The purpose of this study is to evaluate if the use of a bilateral nerve block with a local anesthetic (ropivacaine), as part of a standard of care pain control regimen (called multimodal analgesia \[MMA\]), has a favorable effect on our institutional MMA pain regimen. Subjects will go through the following study procedures: review of medical history and medications subjects have taken within a month prior to surgery. Subjects will be randomly assigned to one of the two study groups (1:1) to receive either, an ultrasound-guided bilateral nerve block (called "Pecto-Intercostal Fascial Block \[PIFB\]") with ropivacaine or saline 0.9 solution, in addition to our institutional MMA regimen. A baseline line pain and nausea scores will be recorded before surgery. The block will be performed right after general anesthesia induction. The details about the surgery will be collected. Pain assessments, nausea and vomiting scores will be registered at 12, 24 and 48 hours after surgery as well. Lastly, a follow up phone call will be made by the research team to conduct a pain-detect questionnaire at 30, 60 and 90 days after surgery.

Study design This is a single-center, prospective, randomized, placebo-controlled, double-blinded trial in patients undergoing open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center. All study procedures will be done in accordance with institutional and ORRP-IRB guidelines.

Study participants Adult patients undergoing open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center with an American Society of Anesthesiologists (ASA) physical status of I to IV who are scheduled to undergo open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center.

Sample size Eighty-four subjects who give written informed consent to participate in the study and who meet all inclusion and no exclusion criteria will be included in a single treatment group.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female patients aged \> 18
* Undergoing primary cardiac surgery requiring sternotomy
* Able to provide a signed written informed consent
* Able to speak, read, and write in English
* American Society of Anesthesiologists (ASA) physical status I-IV

Exclusion Criteria:

* Any documented cognitive or psychological disorders that, in the opinion of the principal investigator, can interfere with the patients' pain perception
* Diabetes Mellitus with documented neuropathic pain
* Vulnerable populations: pregnant females, prisoners, breast feeding
* Contraindication to nerve block: local infections, bleeding disorders, chest wall deformity, allergy to local anesthetic or dexamethasone
* Previous cardiac surgery
* Previous history of chronic pain diseases requiring consistent analgesic therapy for at least 1 month prior to surgery
* Presence of any medical condition that, in the opinion of the principal investigator, should exclude the patient from the study
* BMI ≥ 40 kg/m2
Single-step Placenta Accreta Resective Technique Tourniqueted vs Absence, Conservative Uterine Surgery

Background: An optimal international standard for PAS surgery is not yet available, and the establishment of a suitable surgical method is an important focus of in PAS management.

Objective: To assess the efficacy and safety of tourniquet uses for conservative approach in the management of placenta accerta spectrum.

Patients and Methods: 40 pregnant women who underwent conservative management of placenta accrete at Kasr El-Aini hospital (Obstetrics and gynecology department - Faculty of medicine - Cairo university) were included and were divided according to the use of tourniquet into 2 equal groups: Study group (tourniquet group): consists of 20 women for whom tourniquet was used in the lower part of the uterus during surgical treatment of placenta accreta spectrum.Control group (no tourniquet group): consists of 20 women for whom no tourniquet was used.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant females with previous CS deliveries (at least 1).
* Patients with ultrasound criteria of placenta accerta spectrum.
* Patients desiring fertility (uterine conservation).
* Patients with gestational age that completed 34 weeks (or more) confirmed by the 1st day of the LMP or 1st trimester ultrasound scan.

Exclusion Criteria:

* Maternal age above 40 years.
* Chronic medical disorders (e.g., cardiac, renal, DM and hepatic diseases).
* Patients presented with severe antepartum hemorrhage (unstable vital signs).
* Patients requested radical management (caesarean hysterectomy).
Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment

This study is aimed to compare the pharmacokinetics of levonadifloxacin and its sulfate metabolite after a single dose of oral WCK 2349 1000 mg in patients with hepatic impairment and healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI): 18.0 - 38.0 (Body weight in kg / Height in m2), both inclusive.
* Subjects must fulfill the following criteria:

Patients with hepatic impairment:

* Considered clinically stable in the opinion of the Investigator
* Patients with different degrees of impaired hepatic function as assessed by a Child-Pugh classification score: mild (5-6 points), moderate (7-9 points) and severe (10-15 points) impaired hepatic function.
* Documented history of cirrhosis diagnosed by liver biopsy, ultrasonography (USG), computed tomography (CT) scan, or magnetic resonance imaging (MRI) OR

Healthy volunteers:

* Have normal hepatic function
* Participants with a history of self-limited hepatitis A with complete resolution documented at least 6 months prior to entry will be allowed

Exclusion Criteria:

* Known hypersensitivity to quinolones/fluoroquinolones.
* Subjects must not fulfill the following criteria:

In hepatically impaired patients:

* Use of prohibited concomitant medication, with the exception of those essential for the management of hepatic impairment and the treatment of concomitant stable medical conditions for the hepatically impaired patients as per the discretion of the Investigator.
* Fluctuating or rapidly deteriorating hepatic function as indicated by recent history or widely varying or worsening of clinical and/or laboratory signs of hepatic impairment as judged by the Investigator.
* Concomitant treatment with Interferon or other prohibited medications
* Active stage 3 and stage 4 encephalopathy OR

Healthy Volunteers:

* Use of any concomitant medication within 7 days from the screening except those deemed safe for the study by the Investigator and Medical Monitor.
* History of any clinically significant chronic and/or active hepatic disease including elevations of serum transaminases including aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \[except those which are considered non-significant by the Investigator; however, these should not exceed 1.5 times the Upper Limit of Normal (ULN)\], hepatitis (Hepatitis A, B or C), biliary tract disease, or history of any significant gastrointestinal surgery.
Physiotherapy in Hematopoietic Stem Cell Transplantation

Research project with patients undergoing allogeneic hematopoietic transplantation in the hematology and hemotherapy Clinical Hospital Universitario Virgen de la Arrixaca. The main objective is to assess the differences in skeletal muscle and functional variables in the experimental group underwent a physiotherapy treatment that takes place during the pre-and post-transplant period, compared to a control group.

The main characteristics of the study are:

* Randomized, prospective and longitudinal in patients receiving allogeneic hematopoietic stem cell transplantation clinical trial.
* A descriptive study of skeletal muscle characteristics of patients undergoing allogeneic hematopoietic transplantation for hematologic malignancies before and after carrying out a treatment with stem cells.
* Clinical study of the variables of strength, mobility, proprioception and upper and lower pain in patients with hematologic malignancy member before and after cancer treatment.
* Clinical study of the effectiveness of physiotherapy treatment in clinical characteristics (strength, mobility, proprioception and pain) in patients undergoing allogeneic stem cell transplantation.
* Clinical study of psychosocial variables that are affected by hematological treatment, and the influence on them of a physiotherapy treatment.

The data obtained in this project to identify and treat those functional deficits that appear as a result of cancer treatment and influencing patients, regarding the evolution of the disease and its treatment. They will use different psychosocial questionnaires and functional tests based on scientific evidence and the reliability of these, as well as its specific design for patients with hematologic cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 70 years.
* Patients with a diagnosis of hematologic malignancy that will be subjected to hematopoietic transplantation.
* Patients offer sufficient guarantee adherence to protocol.
* Patients who have previously signed informed consent.

Exclusion Criteria:

* Patients with inability to walk, before treatment.
* Patients whose medical judgment contraindicated inclusion in a physiotherapy intervention.
* Patients with psychotic traits, brain damage or senility prevention of the correct understanding of physical therapy.
* Patients with inability to sign informed consent or understanding.
Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of COVID-19 Vaccination

Our objective is to determine the effectiveness of varied outreach methods to children age 12-17 years old who are due for a well child check visit and don't have one scheduled in the next 45 days on the outcomes of appointment scheduling, appointment completion, and receipt of the COVID-19 vaccination.


Eligibility Criteria:
Inclusion Criteria:

* age 12-17 years
* has not had a well child check in past 365 days
* no future well child check visit scheduled
* parent preferred language = English or Spanish

Exclusion Criteria:

* phone number not available in electronic health record
Minimally Invasive Treatment of Primary Great Saphenous Vein (GSV) Insufficiency Using High Intensity Focused Ultrasound (HIFU)

This is a one-arm, open label, prospective, single-center study. Primary objective To evaluate the feasibility of HIFU for treatment of Great Saphenous Vein using assessments of patient experience and response to treatment.

Secondary objective To assess the general safety and ablation rate outcomes following HIFU treatment of GSV


Eligibility Criteria:
Inclusion Criteria:

1. Candidate for venous procedure with primary GSV insufficiency involving reflux in the segment to be treated
2. CEAP-clinical classification ≥ 2
3. Physical condition allowing ambulation after the procedure.
4. Agree to comply with the Clinical investigation plan and follow-up schedule of the study
5. Targeted tissue reachable for treatment with the device - meaning between 5mm and 24mm below the skin surface.
6. Age over 22 years at the time of enrollment.
7. No acute venous thrombosis.
8. No complete or near complete deep vein post-thrombotic disease.
9. Patient has signed and understood the written informed consent.

Exclusion criteria

1. Patient is pregnant
2. Known allergic reaction to anesthetics to be used.
3. Legally incapacitated or imprisoned patients
4. Patient's vein target not clearly visible on the ultrasound images (in B mode) at the inclusion visit.
5. Patient participating in another clinical trial involving an investigational drug or device.
6. Ankle-brachial index \<7 (ABI)
7. Undergoing active anticoagulant therapy within the last 6 months
8. Diameter of the treated anatomical segment below ≤ 2mm

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The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO System Use in Conjunction With VISITAG SURPOINT Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation.

Observational, multi-center, non-randomized, post-market study. This is a nested sub-study of the REAL AF Registry. Consecutive symptomatic drug refractory paroxysmal atrial fibrillation (PAF) patients from the registry will be screened for enrollment to this sub-study per inclusion and exclusion criteria.

Enrolled QDOT PAS subjects are defined as consented patients with symptomatic paroxysmal atrial fibrillation (PAF) enrolled in the REAL AF registry. These enrolled subjects will be treated with the commercially available QDOT MICRO™ system (QDOT MICRO™ catheter and nGEN™ generator) in conjunction with VISITAG SURPOINT™ Module. Subjects are required to complete scheduled assessments within 12 months of the index procedure, and additional two assessments at 24 and 36-months post procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic drug refractory paroxysmal (AF episode terminate spontaneously within 7 days) who, in the opinion of the investigator, are candidates for ablation for AF
2. 18 years of age or older
3. Able and willing to participate in baseline and follow up evaluations for the full length of the sub-study
4. Willing and able to provide informed consent for this sub-study

Exclusion Criteria:

1. Patients who have undergone catheter ablation for atrial fibrillation (PVI, roof line, posterior wall ablation...)
2. Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan
3. Persistent or long-standing persistent AF
4. In the opinion of the investigator, any known contraindication to an ablation procedure
Capsule Endoscopy in Iron Deficiency Anaemia

This project aim to investigate whether wireless capsule endoscopy(WCE) has a similar diagnostic yield as conventional endoscopy in detecting the cause of iron deficiency anemia (IDA)

IDA is common and 90-95% of cases are caused by bleeding from ulcers, tumours or vascular malformations in the oesophagus, stomach, duodenum, small intestine or the large bowel.Bleeding from more than one localisation is common.

International guidelines recommend bidirectional endoscopy(gastro- and colonoscopy) to detect and treat the source of bleeding.

Our hypothesis is that WCE is non-inferior to the combination of gastroscopy and colonoscopy in locating GI-bleeding and that complete examinations will be achieved in ≥90% of the examinations.

Eligibility Criteria:
Inclusion Criteria:

* Referred to flexible endoscopy for a verified Iron Deficiency Anaemia

Exclusion Criteria:

* Unwillingness to participate
* Not able to provide informed consent
* Not understanding the instructions
* Severe cardio-vascular disease New York Heart Association III-IV
* Symptoms of bowel obstruction/previous bowel obstruction
* Bowel surgery except for end to end anastomosis in the colon
* Pregnancy