cyrilzakka/clinical-trials huggingface dataset:
Advanced XLIF Monitoring Pilot Study

Though the utility of NVM5 neuromonitoring by stimulating within the surgical site during XLIF has been demonstrated, it is hypothesized that more information may be gathered if a greater section of the motor neural pathway was monitored (i.e., stimulation above the surgical site and recording the subsequent muscle response in the lower limbs). Currently, there has not been demonstrated a practical method of stimulating the lumbosacral nerve roots locally, but well-above the surgical site in this fashion.

This protocol is intended to evaluate the feasibility and reproducibility of using surface stimulation and return (anode) electrodes to stimulate the lumbosacral nerve roots, and record responses from the relevant innervated muscle groups of the lower limbs.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female spine surgery patients who are at least 18 years of age
2. Surgical candidates for lateral approach lumbar spine surgery at spinal levels L2 to L5, inclusive of L4-5
3. Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the evaluation

Exclusion Criteria:

1. Currently undergoing surgical treatment at any spinal level other than L2 to L5, including S1
2. Pregnant women
3. Implanted pacemaker, defibrillator, or other electronic devices
4. Involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
5. Underlying neurological disease or neurological deficit that is not associated with the condition for which he/she is seeking surgical intervention (e.g., diabetic peripheral neuropathy)
HDP vs NS Intra-articular Injection Among KOA With Obese Patient

The aim of this randomized controlled trial study was to compare the effect of intra-articular injection of Hypertonic Dextrose Prolotherapy (HDP) with Normal Saline (NS) in the clinical improvement of knee osteoarthritis (KOA) patients with comorbid obesity. The main questions to be answered are:

* How does the effect of HDP versus NS intra-articular injection compare to the numerical rating score (NRS) in obese KOA patients?
* How does the effect of HDP versus NS intra-articular injection compare to scores of The Western Ontario and McMaster Universities Arthritis Index (WOMAC) in obese KOA patients?
* How does the effect of HDP versus NS intra-articular injection compare to the thickness of the femoral cartilage in obese KOA patients?

Participants who meet the inclusion and exclusion criteria will be randomized based on the order of the outpatient department each day, with odd numbers as the HDP intervention group and even numbers as NS. They received ultrasound-guided intra-articular injections on day 1 and day 30.

Researchers will compare HDP versus NS groups to see which group improves NRS, WOMAC, and femoral cartilage thickness.

This is a randomized controlled study, which recruited KOA patients with obese comorbidity who were treated at the Outpatient Department of Physical Medicine and Rehabilitation at Rumah Sakit Daerah Haji Provinsi Jawa Timur, Surabaya, Indonesia from May to August 2023. The participants were divided into two groups, including HDP versus NS injections.

Each study participant's identity including age, gender, weight, height, and BMI was recorded. Then an evaluation of the NRS, WOMAC score, and femoral cartilage thickness was carried out using ultrasound.

This study assessed using the NRS scale for pain reduction on a scale of 0 to 10 (0 means no pain, while 10 means very pain). The WOMAC Score consists of 24 questions with four scales, namely 0: none, 1: mild, 2: moderate, 3: severe, and 4: very severe. Femoral cartilage thickness scan using ultrasound with millimeter units.

Eligibility Criteria:
Inclusion Criteria:

* Patient was diagnosed with knee osteoarthritis (KOA).
* Patient was diagnosed with obesity.

Exclusion Criteria:

* Patient with a history of knee trauma.
* Patient with a history of knee surgery.
* Patient with a history of intra-articular injection before.
China Takayasu Arteritis Registry (CTA Registry)

Takayasu arteritis (TA) is a chronic large-vessel vasculitis that mainly affects the aorta and its major branches. The epidemiology and pathophysiology of TA is still unclear in China, although many studies have been done. Our previous study supporting by National Natural Science Foundation of China indicated the cytokines such as hs-CRP, NT-proBNP and tumor necrosis factor-alpha (TNF-α) can be used to monitor TA activity, and HLA gene alleles were associated with TA in Chinese han population. Further investigations with larger samples are needed to fully understand the a pathophysiology of TA. The purpose of this study is to build a Chinese national registry system for TA to obtain real-world information, such as current status of characteristics, diagnosis, disease activity, the severity of disease, treatment and outcomes of Chinese TA patients. To analysis and development of effective disease monitoring and treatment strategies.

Takayasu arteritis (TA) is a chronic vasculitis that causes inflammation of the aorta and its main branches and is characterized by adventitial thickening and cellular infiltration of the tunica media, with local destruction of vascular smooth muscle cells and elastin. The disease is very rare but most commonly occurs in China. In the last decade, the results of our study indicated that HLA-DPB1, HLA-DQA1, HLA-DQB1 and HLA-DRB1 gene alleles were associated with TA in Chinese Han population. And the clinical features of patients with TA were analyzed. The cytokines such as hs-CRP, NT-proBNP and tumor necrosis factor-alpha (TNF-α) can be used to monitor TA activity. But there are still many unknown fields in TA, such as the epidemiology and pathophysiology. This study is to build a Chinese national registry system for TA to obtain real-world information, such as current status of characteristics, diagnosis, disease activity, the severity of disease, treatment and outcomes of Chinese TA patients. To analysis and development of effective treatment strategies.

Eligibility Criteria:
Inclusion Criteria:

* Age at disease onset \< 40 years. (Development of symptoms or findings related to Takayasu arteritis at age \<40 years)
* Claudication of extremities. (Development and worsening of fatigue and discomfort in muscles of 1 or more extremity while in use, especially the upper extremities)
* Decreased brachial artery pulse. (Decreased pulsation of 1 or both brachial arteries)
* BP difference \>10 mm Hg. (Difference of \>10 mm Hg in systolic blood pressure between arms)
* Bruit audible on auscultation over 1 or both subclavian arteries or abdominal aorta.
* Arteriogram abnormality. (Arteriographic narrowing or occlusion of the entire aorta, its primary branches, or large arteries in the proximal upper or lower extremities, not due to arteriosclerosis, fibromuscular dysplasia, or similar causes; changes usually focal or segmental)

Exclusion Criteria:

* Vessel lesions that could be entirely due to atherosclerosis.
* Giant cell arteritis or other infectious forms of large vessel vasculitis.
Investigating the Effect of Simulated Live Piano Music on Preoperative Cancer Patients, Health Care Providers and Hospital Volunteers Using Validated Questionnaires and Proteomic Analysis

The goal of this research study is to learn if simulated live piano music can change the amount of stress felt in patients with cancer before surgery, health care providers caring for cancer patients, and/or hospital volunteers.

This is an investigational study.

Up to 304 participants (200 patients, 52 volunteers, and 52 healthcare providers) will be enrolled in this study. All will take part at MD Anderson.

If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. Participants in the first group will wait for 30 minutes in a standard pre-surgery waiting area without music. Participants in the other group will go to a waiting room with a Steinway Spirio grand piano that plays 30 minutes of simulated piano music.

A Steinway Spirio grand piano is a special type of piano that plays music by itself (also called a player piano). The music will be chosen by the study staff and pre-recorded on the piano. Although the keys will move on the piano as if someone is playing the piano, you will be alone in the room.

You will have an equal chance (50/50) of being assigned to either group. Both you and the person in charge of this study will know to which group you have been assigned. You do not get to choose which group you are in.

Study Procedures:

Before and about 30 minutes after you either listen to music or stand in the waiting room without music:

* Blood (about 1½ teaspoons each time) will be drawn to learn how your body is responding to the music or silence by measuring the amount of cortisol in your body (a type of hormone related to stress) and for biomarker testing. Biomarkers are found in the blood and may be related to your reaction to the music or silence. If you are a healthcare provider or volunteer, you will not have these blood draws.
* You will complete 2 questionnaires about your anxiety and stress levels. It should take about 20-30 minutes to complete.

Length of Study:

You participation on this study will be over after the last blood draw and questionnaire are completed.

Eligibility Criteria:
Inclusion Criteria:

1) Patients: To preserve a homogenous cohort and comply with the departmentally-organized research infrastructure, we will include pPreoperative abdominal cancer patients undergoing surgery, or healthcare provider from all specialties at MDACC or volunteer from MDACC Volunteer Service.

Exclusion Criteria:

1. Cannot give informed consent
2. Are deaf or hearing-disabled
3. Less than 18 years in age
4. Profess extreme dislike of music.
5. Wait time is longer than 240 min.
6. Underlying structural brain abnormality or neurologic comorbidity
The Effect of Feeding Infant Formula With Enriched Protein Fractions

This study is intended to evaluate the nutritive effects of study formulas on growth and cognitive outcomes.

To evaluate the nutritive effects of study formulas on growth and cognitive outcomes.

Eligibility Criteria:
Inclusion Criteria:

* 10-14 days of age
* Exclusively formula-fed
* Singleton birth
* Gestational age of 37-42 weeks
* Birth weight of 2500g to 4000g
* Signed Informed Consent Form

Exclusion Criteria:

* History of underlying metabolic or chronic disease
* Congenital malformation
* Condition which is likely to interfere with food ingestion, normal growth, development and evaluation
* Evidence of feeding difficulties or intolerance
* Immunocompromised
* Head/brain disease/injury
10+10+30 Infant Vaccines Communication Via Radio in Ethiopia

A cohort study to investigate the effectiveness of radio intervention comprising 10-minute of drama, 10-minute of discussion led by community extension workers, and 30-minute phone-in from listeners on childhood vaccination coverage and timeliness

The evaluation is conducted in 2 districts located in the Oromia region of Ethiopia. One of the districts will be allocated to receive the 3-month radio intervention while the other district that will not have access to the radio intervention will serve as the control.

Data collection includes survey of mothers at two "key" times: at baseline (when infants are at most 5 weeks old; but before beginning the intervention) and at endline (including examination of infant vaccination records) at most 21 days after the end of the radio intervention. The same mothers and infants to be followed at endline.

Eligibility Criteria:
Inclusion Criteria:

Mother, with infant of at most 5 weeks old; Lives in the study district; Consents to participate in study

Exclusion Criteria:

Mother, with infant of more than 5 weeks old; Does not live in study district; Does not consent to participate in study
An Open Label Trial of ALD403 (Eptinezumab) in Chronic Migraine

An evaluation of long term safety of repeat ALD403 doses in Chronic Migraine


Eligibility Criteria:
Inclusion Criteria:

* Males and females between 18 and 65 years of age, inclusive, who were diagnosed with migraines at ≤ 50 years of age, and have a history of chronic migraine for ≥ 12 months before screening.

Exclusion Criteria:

* Receipt of any monoclonal antibody treatment (within or outside a clinical trial) within 6 months before screening.
* Confounding and clinically significant pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome).
* Psychiatric conditions that are uncontrolled and/or untreated, including conditions that are not controlled for a minimum of 6 months prior to screening. Patients with a lifetime history of psychosis, mania, or dementia are excluded.
* History or diagnosis of complicated migraine (ICHD-III beta version, 20134), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or sporadic and familial hemiplegic migraine.
Effect Of Different Diaphragmatic Myofascial Release Approaches On Low Back Pain And Quality Of Life Among Young Females With Irritable Bowel Syndrome

this study will be conducted to investigate the effect of different diaphragmatic myofascial release approaches on low back pain and quality of life among young females with irritable bowel syndrome

Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder linked to disruptions in autonomic nervous system regulation, gut inflammation, alterations in stool frequency, and visceral hypersensitivity. Irritable bowel syndrome (IBS) is a chronic condition affects 7 to 21% of the general population.The symptoms usually include abdominal cramping, discomfort or pain, bloating, loose or frequent stools and constipation.The diaphragm has a fundamental role in defining posture, its maintenance, and body position changes; dysfunction of the diaphragm is one of the recognized be causes of low back and sacroiliac joint pain. People with low back pain often experience early fatigue of the diaphragm muscle, altered and reduced excursion during respiration, and inadequate proprioceptive activation.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with irritable bowel syndrome
* Young female subjects
* All patients will have low back pain.
* All subjects will be clinically and medically stable when attending the study

Exclusion Criteria:

* Lack of attention and cooperation
* History of cancer and any systemic disease
* Pregnancy
* History of any structural gastrointestinal pathology or surgery
* History of repeated inflammatory gastrointestinal pathology
* Diabetes mellitus and lactose intolerance.
* Abuse of laxative
* Depression
* Celiac disease
* Endocrine disorders as hypothyroidism and hyperthyroidism.
* Gastrinoma
* Recent/unhealed rib fracture
* History of any lumbar spine serious pathology ( tumor, infection fracture, osteoporosis , long term use of steroid, rheumatoid arthritis and surgery )
Post-marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2)

The purpose of this study is to investigate the efficacy of cilostazol in preventing recurrence of cerebral infarction and the safety of long-term administration of the drug (100 mg, twice daily) in patients with cerebral infarction (excluding cardiogenic cerebral embolism) in a multi-center, double-blind, parallel-group comparison with aspirin (81 mg, once daily).


Eligibility Criteria:
Inclusion Criteria:

1. Patients with stable medical conditions for 182 days (26 weeks) after occurrence of cerebral infarction
2. Patients in whom the infarct-related foci was detected by X-ray CT scan or MRI
3. Patients aged 20 to 80 years (inclusive) at time of consent
4. Patients with none of the following cardiac diseases that may be associated with cardiogenic cerebral embolism: mitral stenosis, prosthetic heart valve, endocarditis, myocardial infarction within 6 weeks after occurrence, ventricular aneurysm, endocardial thrombosis, mitral valve prolapse (patients less than 45 years of age in whom no other cause was identified), atrial fibrillation, sick sinus syndrome, idiopathic cardiomyopathy, and patent foramen ovale
5. Patients without asymptomatic cerebral infarction
6. Patients who have neither undergone nor are scheduled to undergo percutaneous transluminal angioplasty or revascularization for the treatment of cerebral infarction
7. Patients without severe disturbances/impairments following occurrence of cerebral

Exclusion Criteria:

1. Patients with hemorrhage or bleeding tendency (hemophilia, capillary fragility, intracranial hemorrhage, hemorrhage in the digestive tract, hemorrhage in the urinary tract, hemoptysis, and hemorrhage in the vitreous body)
2. Pregnant, possibly pregnant, or nursing women
3. Patients with ischemic heart failure
4. Patients with peptic ulcer
5. Patients with severer blood disorders
6. Patients with severe hepatic or renal
7. Patients with malignant neoplasm or patients who have received any therapy for malignant neoplasm within 5 years prior to entering the study
8. Patients with a history of hypersensitivity to salicylic acid formulations or ingredients of cilostazol tablets
9. Patients with aspirin asthma (asthma attacks induced by nonsteroidal antiinflammatory analgesic agents) or a history of aspirin asthma
10. Patients who are being treated with ticlopidine hydrochloride
11. Patients who are participating in another study for an investigational drug
12. Patients who are otherwise judged inappropriate for inclusion in the study by the investigators
Effect of Temperament, Anxiety and Depression on Immuninity in Colorectal Cancer Patients. Effetti Del Temperamento, Dell'Ansia e Della Depressione Sulla Sopravvivenza Globale e Sulla Risposta Immunitaria Del Paziente Affetto da Adenocarcinoma Colo-Rettale.

Aim of the study is to evaluate if Temperament, Anxiety and Depression can affect Immunity and influence Survival in Colorectal Cancer Patients

120 prospective patients, with non-metastatic colorectal cancer, will be evaluated with questionnaires and auto-questionnaires in order to assess temperament, anxiety and depression. The immunity status will be assessed by a blood sample with the aim to evaluate cell-mediated immunity.

Survivall will be related to level of anxiety/temperament/depression and cell-mediated immunity.

Univariate and multivariate model analisys will be performed in order to evaluate if anxiety/temperament/depression and cell-mediated immunity can be considered as prognostic factors.

Eligibility Criteria:
Inclusion Criteria:

diagnosis of non-metastatic colorectal cancer

Exclusion Criteria:

previous other primary malignancies immunodepression diagnosis of major deppression diagnosis of anxiety/depression syndrome
Nonfunctional Pancreatic NET and PET Imaging

Predicting aggressive behavior in the group of nonfunctional pancreatic neuroendocrine tumors (NF P-NET) remains a difficult problem in clinical practice. At present, the treatment planning in P-NET is significantly restricted by the limited results of conventional imaging. In addition, increasing use of multidetector computed tomography (MDCT) and magnetic resonance imaging (MRI) is increasing the number of NF P-NETs detected. Somatostatin receptor scintigraphy (SRS) combined with anatomical imaging are the conventional modalities in imaging of P-NET, but by these methods the diagnostic accuracy still remains compromised. Furthermore, recently encouraging results have been obtained in P-NET using 68Ga-labelled somatostatin analog, DOTA-1-NaI3-octreotide (68Ga-DOTANOC) positron emission tomography-computed tomography (PET-CT).

The aim of the current project is to evaluate the possibility to enhance the diagnostic accuracy by using dual trace functional imaging 18F-labelled fluorodeoxyglucose (18F-FDG) and 68Ga-DOTANOC PET-CT imaging in patients with NF P-NET. The study consists of 20 patients with NF P-NET. The patients enrolled in the study will be imaged 68Ga-DOTANOC and 18F-FDG PET-CT followed by surgery or follow-up with endoscopic ultrasonography (EUS) biopsies. The data will be collected between autumn 2015 and spring 2018.


Eligibility Criteria:
Inclusion Criteria:

* suspicion of nonfunctional P-NET on primary CT (i.e hypervascularity) or MRI
* signed informed consent

Exclusion Criteria:

* vulnerable study subjects such as described in Finnish law concerning clinical studies (disabled, children, pregnant or breast-feeding women, prisoners) will not be included.
A Study to Learn How the Study Medicine Danuglipron is Taken Up Into the Blood and If Danuglipron Changes How the Body Processes Other Study Medicines (Atorvastatin and Rosuvastatin) in Healthy Adults Who Are Overweight or Obese

The purpose of this study is to learn the following about the study medicine, danuglipron, after multiple days of dosing in healthy adults who are overweight or obese:

* how the study medicine, danuglipron, is taken up into the blood
* if the study medicine, danuglipron, changes how the body processes other study medicines (Atorvastatin and Rosuvastatin)
* about the safety and tolerability of danuglipron

The study will take place in 4 Cohorts (groups). The total number of weeks of the study is about 23 (about 6 months) for Cohort 1 and 22 weeks (about 5.5 months) for Cohort 2, 21 weeks (about 5 months) for Cohort 3 and 20 weeks (about 5 months) for Cohort 4.


Eligibility Criteria:
Key Inclusion Criteria:

* 18 to \< 65 years of age
* Body mass index (BMI) of ≥25.0-45.4 kg/m2; and a total body weight \>50 kg (110 lb)

Key Exclusion Criteria:

* Evidence or history of any clinically significant medical conditions or laboratory abnormality
* Any condition possibly affecting drug absorption
* Known intolerance/hypersensitivity to a GLP-1R agonist and/or known hypersensitivity or contraindication to atorvastatin (Cohort 1 and 3 participants) or rosuvastatin (Cohort 2 and 4 participants)