cyrilzakka/clinical-trials huggingface dataset:
Prospective Randomized Feasibility Study Comparing Manual vs. Automatic Position-Adaptive Spinal Cord Stimulation With Surgical Leads

The main purpose of this study is to establish the extent that chronic pain patients implanted with surgical, laminectomy-type, leads experience position-related variation in spinal cord stimulation therapy and to investigate the effects of manual versus automatic position-adaptive spinal cord stimulation on clinical outcome.

A single-center, prospective, randomized study with a two-arm crossover design. The primary objective of this study is to establish threshold and therapeutic stimulation parameters for the RestoreSensor neurostimulator in response to postural changes. The secondary objective is to compare the effectiveness of spinal cord stimulation with manual versus automatic position-adaptive settings for chronic refractory low back and/or extremity pain.

Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature adults between 18 and 70 years old
* Patients with chronic refractory back and/or leg pain associated with failed back surgery syndrome, post-laminectomy pain, radicular pain syndrome or radiculopathy refractory to conservative and surgical interventions
* \> 50% pain reduction during the trail period
* Willing and able to comply with the requirements of the protocol including follow-up requirements
* Willing to sign a study specific informed consent

Exclusion Criteria:

* Previous SCS treatment
* Surgically remediable spinal condition
* Active local or systemic infection
Prognostic Value of Finger Blood Pressure in Arteriovenous Fistula Care

The goal of this trial is to investigate the prognostic value of monitoring finger blood pressures (FBPs) in predicting the success of surgically created arteriovenous fistula (AVF) for patients with end stage renal disease. The main questions it aims to answer is:

- Can FBPs predict AVF maturation?

Participants will undergo FBP measurements at pre-op, immediately post-op, 4 weeks and 6 weeks post-AVF creation.


Eligibility Criteria:
Inclusion Criteria:

* Participants has documented Chronic Kidney Disease (CKD), determined by Glomerular Filtration Rate (GFR)
* Participant is recommended for renal replacement therapy based on clinical assessment of renal function as well as CKD staging, as documented in clinical notes.
* Haemodialysis was chosen as the most appropriate renal replacement therapy
* Participant is able to consent to the creation of an AVF in preparation for hemodialysis.
* Participant is able to adhere to follow-up assessments of AVF maturation, if applicable.

Exclusion Criteria:

* Subject had a previous AVF and is now undergoing surgery for another AVF creation
* Subject has amputation distal to AVF
* Subject is pregnant or planning to conceive
* Participants is unable to consent
Influence of an Inspiratory Muscle Fatigue Protocol on Older Adults on Respiratory Muscle Strength and Heart Rate Variability

Respiratory muscle training represents an effective method increasingly utilized in both sports and healthcare domains, employing various devices, among which threshold devices are prominent. The aim of this study is to determine the relationship between inspiratory muscle fatigue and maximal inspiratory pressure, diaphragmatic strength (guided by ultrasound image) and heart rate variability.

According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue in older adults could influence cardiorespiratory function.

In this study, subjects will be divided into three groups: the experimental group , the activation group and the control group.

Measurements of variables, such as maximal inspiratory pressure, heart rate variability and diaphragmatic strength (ultrasound image), will be conducted.

This is a randomized control trial. The experimental group (EG) will perform the diaphragmatic fatigue protocol using a specific inspiratory endurance test, in which volunteers, one-on-one, and in a single session, will breathe against submaximal inspiratory loads equivalent to 60% of their Maximum Inspiratory Pressure (MIP) through a threshold valve device. The participants will follow a free pattern of breathing until they are unable to establish flow during at least 3 maximum inspiratory efforts.

The activation group (AG) will perform the protocol of 2 sets of 30 repetitions at 15% of their MIP, one-on-one, and in a single session, using a threshold valve device.

The control group will do a seat and wait.

The interventions will be supervised by a physiotherapist. The primary outcomes will be

Respiratory muscle strength will be assessed using a respiratory pressure meter or manometer designed, and with ultrasound image measuring the cross sectional area of the diaphragm at 8-9th rib level and speed of contraction with a deep and fast inspiratory manoeuver. This will be done immediately before intervention and immediately after intervention

Heart rate variability (HRV) will be assessed using a heart rate sensor Polar H10.

Eligibility Criteria:
Inclusion Criteria:

* Being over 60 years old.
* Physical independence in terms of gait and transfers.

Exclusion Criteria:

* Having any pathology that prevents the performance of physical activity.
* Subjects with impaired cognitive abilities.
* Subjects with tympanic perforation or middle-inner ear pathology.
* Subjects with pulmonary hypertension, decompensated heart or respiratory failure.
* Subjects who have undergone lower limb surgery within the past 12 months.
Effects of Osteopathic Manipulative Treatment on Postural Control in Parkinson's Disease/Pisa Syndrome Patients

The aim of the study is to evaluate the efficacy of osteopathic manipulations added to an intensive, multidisciplinary rehabilitative (MIRT) program on postural control of PD-PS patients.

Pisa Syndrome is frequently associated with Parkinson Disease and it is characterized by a trunk lateral flexion higher than 10 degrees that is reversible with the lying position. Its pathophysiology is multifactorial, and it is probably different depending on disease onset duration. However, a relevant association between subjective visual vertical misperception and the PS involved side was recently described. Moreover, an impairment in postural control in PD-PS patients has been recognized. Nowadays, physical therapy is the standard treatment and it is proposed to ameliorate paraspinal muscle hyperactivity and balance, as showed by previews descriptive and clinical studies. Despite being physical therapy a cornerstone in PD-PS axial symptoms treatment, the therapeutic protocol for postural control in PD-PS patients is under active study.

In recent years, preliminary studies described the effects of osteopathic manipulative treatment on motor functionality and balance in PD patients in a multidisciplinary setting, which is in line with the evidence of the need of a multidisciplinary and intensive approach to achieve better outcomes. However, the effect of OMT has never been investigated in PD-PS patients. The aim of the study is to evaluate the effects of OMT on postural control of PD-PS patients undergoing the MIRT program. Literature reported the possible benefit of OMT on the balance of healthy subjects, possibly interacting with the multisensorial integration of balance. 24 PD-PS patients are enrolled and randomized in two groups. Posturography is performed to assess Eye-closed Sway Area (ECSA) at baseline and 30 days after enrolment. The investigator who perform posturography and trunk inclination assessment is kept blinded. Trunk inclination is measured with "DIERS Formetric 4D". Other variables considered in the investigation are Eye-opened sway area (EOSA), Trunk Lateral Flexion (TLF), Kyphothic Angle (KA), Unified Parkinson Disease Rating Scale (UPDRS), Six-minute Walking Test (6MWT).

Eligibility Criteria:
Inclusion Criteria:

* Pisa Syndrome and Parkinson Disease
* PS Onset \&lt; 12 months
* TLF \&gt; 10 degrees

Exclusion Criteria:

* Scoliosis or spine deformity
* Changes of PD pharmacological therapy within 3 months
* Co-morbidity with other neurological disease
An Observational Study of Bevacizumab in Chinese Patients With Metastatic Colorectal Cancer

This observational, multicenter, prospective study will evaluate the use of bevacizumab in real clinical practice in chinese patients with metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed metastatic colorectal cancer patients Having initiated treatment with bevacizumab

Exclusion Criteria:

* non-metastatic colorectal cancer patients not recieved bevacizumab
Treatment of Advanced AIDS Patients With Dextrin Sulfate

The purpose of this study is to look at the safety and effectiveness of dextrin sulfate in AIDS patients who have failed conventional anti-HIV treatment.

Patients have intraperitoneal (IP) catheter placement done at study entry. Infusion with the carrier vehicle (icodextrin 4%) begins 2 weeks later, and 2 days after that, treatment with dextrin sulphate (DS) commences. DS is given three times per week. A nurse delivers initial treatments and the patient and caregiver will be trained to give subsequent treatments until DS has been given a total of 8 weeks. Patient evaluations are done regularly during treatment and observation continues for 24 weeks.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this trial if they:

* Are HIV-positive.
* Have been diagnosed with AIDS and are under treatment to prevent opportunistic (AIDS-related) infection.
* Have had a CD4 cell count greater than 50 microL for at least the past 3 months.
* Have had a viral load of at least 50,000 copies/ml for at least the past 3 months.
* Have used up all other treatment options.
* Are able to understand and give written consent.

Exclusion Criteria

Patients may not be eligible for this trial if they:

* Have been in any other study in the 6 weeks before beginning this study.
* Have an active, opportunistic infection or other infection.
* Have any other long-term medical condition or nervous disorder that might make it difficult for them to finish the study.
FFI and PR Could Improve Bowel Cleansing.

background:The use of enhanced instruction can improve the efficiency of education for bowel preparation regimens. Researchers hypothesized that face-to-face instruction and personalized intervention for inpatient could improve successful bowel preparation rate and patient's compliance with regimens.

Methods:This was an endoscopist-blind,randomized controlled trial. 320inpatients were randomized 1:1 in one of the two study groups. The intervention group received face-to-face instruction and personalized intervention for bowel preparation protocol, while control group received the standard bowel preparation protocol. Patients'demographics, bowel preparation quality, colonoscopy completion and attendance were recorded. Logistic regression was performed to identify predictors of bowel preparation failure.


Eligibility Criteria:
Inclusion Criteria:

* Inpatients undergoing colonoscopy.
* patients older than 18 years.

Exclusion Criteria:

* prior surgery of colorectal resection;
* suspected colonic stricture or perforation;
* incomplete or complete bowel obstruction;
* use of prokinetic agents or purgatives within 7 days;
* Patients with severe gastrointestinal diseases, such as intestinal obstruction or perforation, active ulcerative colitis, toxic colitis and toxic megacolon;;
* pregnancy or lactation;
* Inability to prepare bowel;
* unable to give informed consent.
Transversalis Fascia Plane Block Versus Erector Spinae Plane Block for Analgesia in Inguinal Hernia Repair

Uncontrolled postoperative pain after inguinal hernia repair increases the incidence of postoperative complications.

Inguinal hernia repair is one of the most common surgical procedures in the world. Annually, more than 20 million inguinal hernia repairs are conducted worldwide.

Uncontrolled postoperative pain increases the incidence of postoperative complications. Regional blocks, as a part of multimodal analgesia, can improve pain control in the postoperative period and reduce complications that may arise from using a single mode of analgesia. For example, reliance on opioid analgesia increases the incidence of pruritus, nausea, and vomiting, as well as respiratory depression.

Hebbard first described the ultrasound (US)-guided transversalis fascia plane (TFP) block in 2009. A local anesthetic (LA) injected between the transversus abdominis muscle and its deep investing fascia will block the anterior and the lateral branches of the T12 and L1 nerves.

Erector spinae plane block (ESPB) is a type of facial plane block in which local anesthetic is administered in the plane located between the erector spinae muscle and thoracic transverse process. ESPB blocks the transmission of nociceptive stimuli through the dorsal/ventral rami of the spinal nerve roots, prevents afferent stimuli transmission, and inhibits efferent activation of the sympathetic nervous system and can thus provide both somatic and visceral sensory blockade, which would make it an ideal regional anesthetic technique for abdominal surgery.The effect of ESPB is also achieved through the block of the lateral, posterior, and anterior thoracic wall resulting in multiple levels sensory blocks. Additional proposed mechanism of action could be explained by the epidural spread of the anesthetics.

Eligibility Criteria:
Inclusion Criteria:

* Male patients undergoing elective open unilateral inguinal hernia repair under general anesthesia, ASA status I-II, aged from 20 to 65 years old

Exclusion Criteria:

* Contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis)
* Altered cognitive function
* Body mass index (BMI \> 35 kg/m2)
* Patients who have difficulty understanding the study protocol
* Patients who have any known allergy to study medications
* Advanced hepatic or renal failure
* Chronic opioid consumption
* Patient refusal
Forecasting Seizures Using Intelligent Wearable Technology for Health Tracking

The goal of this interventional study is to develop a personalized seizure risk forecast tool in people with epilepsy.

The main questions it aims to answer are:

* can we develop a future seizure probabilities tool that is more accurate than chance based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables.
* does this tool improve the lives of people with epilepsy?

Researchers will compare a group that does not have access to the forecast tool to a group that does and see if it is accurate and if people with it report that it improved their quality of life.

The primary goal of the study is to demonstrate the accuracy of SeizureWise in predicting the timing of future convulsive seizures using data collected by the wearable EmbracePlus device and data provided by patients with GTCS monitored in outpatient settings.

The secondary goals are:

to assess the clinical impact of SeizureWise on quality of life (QoL), psychological health indicators, and economic and clinical outcomes to assess the clinical impact of visualizing behavioral and physiologic data without forecasting predictions on quality of life (QoL), psychological health indicators, and economic and clinical outcomes

A non-significant risk, open-label, prospective, randomized clinical investigation designed to evaluate the ability of SeizureWise to forecast GTCS occurrence and to assess impact on QoL and seizure management outcomes.

The study will include two phases during which an algorithm based on sensor derived physiological measures is developed and tested with output blinded to the participant. In a final phase participants will be randomized to two arms, one of which will have access to a seizure forecasting risk score.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be diagnosed with or be at risk of epilepsy
* Subjects or their parents or guardians must understand and consent to be in the study;
* Subjects or their parents or guardians must be able to read and communicate in English;
* Subjects or their parents or guardians must be willing and able to comply with study procedures and duration;
* Subjects must have a wrist circumference suitable for wearing the EmbracePlus device.

Exclusion Criteria:

* Subjects, or their parents or guardians for minor study participants, who do not understand the study and the risks;
* Subjects, or their parents or guardians for minor study participants, who are either physically or cognitively incapable of performing study activities (e.g. filling in surveys and daily e-diary);
* Subjects who would be placed at undue medical risk associated with any procedure called for in the protocol; or
* Subjects that are Empatica employees and actively participated in the development of this protocol or development of the Seizure Wise algorithms.
Long Term Follow-Up Study for Subjects Previously Treated With Algenpantucel-L (HyperAcute-Pancreas) Immunotherapy

This protocol (NLG0705) provides a mechanism for the 15-year follow-up period that the FDA requires for all participants in gene transfer protocols and assures that adequate follow-up can be maintained for subjects who have received at least one dose of algenpantucel-L.


Eligibility Criteria:
Inclusion Criteria:

* Receipt of at least one dose of algenpantucel-L within the past 15 years
* Signed consent
A Pilot Study to Evaluate Ultrasonic Surgical Aspiration as a Treatment Modality for Cervical Dysplasia

Ultrasonic surgical aspiration of the cervix may be an effective method of treating cervical dysplasia without compromising the integrity of the cervix in reproductive age women.

Women age 18 to 55 years of age with Cervical Intraepithelial Neoplasia 2 or 3 on colposcopy with a negative EndoCervical Curettage are enrolled in a pilot study comparing ultrasonic surgical aspiration and traditional cervical excision procedure for the treatment of cervical dysplasia. In this pilot study, the patients serve as their own control group. Prior to receiving the traditional treatment for cervical dysplasia consisting of Cold Knife Conization with EndoCervical Curettage, each patient's cervix is treated with ultrasonic surgical aspiration. The aspirate is sent to pathology and the results compared with the findings from the cervical cone biopsy. The patients then are followed with Liquid-based Cytology pap smears every 4 to 6 months until completion of the study enrollment/treatment period.

Eligibility Criteria:
Inclusion Criteria:

* cervical intraepithelial neoplasia II or III
* negative endocervical curettage
* not pregnant
* cervical conization is part of treatment plan

Exclusion Criteria:

* positive endocervical curettage
* pregnant
* medically unable to undergo surgery
Decreasing Delirium Through Music in Critically Ill Older Adults

Critically ill older adults admitted to the intensive care unit (ICU) are at a higher risk to develop delirium, which predisposes them to longer lengths of ICU and hospital stay, increased in-patient mortality, and higher risk of new acquired cognitive impairment and dementia. Music listening is a non-pharmacological intervention that holds potential to decrease ICU delirium. The investigators propose a randomized controlled trial to evaluate the efficacy of a seven-day slow-tempo music intervention on the primary outcome of delirium/coma free days among mechanically ventilated, critically ill older adults.

One million adults in the United States receive mechanical ventilation for acute respiratory failure in the intensive care units (ICUs) annually and up to 80% of them develop delirium during their ICU stay. Presence of delirium predisposes older adults to immediate in-hospital complications including a longer length of ICU and hospital stay, increased risk of in-patient mortality and elevated costs of care. In addition, ICU delirium is associated with long-term post-discharge complications such as development of cognitive impairment and dementia.

Recent research studies exploring pharmacological strategies to manage ICU delirium have not demonstrated efficacy; a limitation also acknowledged in the Society of Critical Care Medicine 2018 Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption guidelines. Music listening is a non-pharmacological intervention that has shown to decrease over-sedation, anxiety and stress in critically ill patients, factors that could predispose to ICU delirium. Our team is now proposing to conduct a large randomized clinical trial called "Decreasing Delirium through Music (DDM) in Critically Ill Older Adults to evaluate the efficacy of a seven-day slow-tempo music intervention on the primary outcome of delirium/coma free days among mechanically-ventilated older adults admitted to the ICU.

Eligibility Criteria:
Inclusion Criteria:

1. Age 50 years or older.
2. English speaking.
3. Admitted to the intensive care unit (medical or surgical).
4. Expected mechanical ventilator support for ≥48 hours.
5. Consentable through a legally authorized representative.
6. Have access to a telephone.

Exclusion Criteria:

1. History of dementing illnesses and other neurodegenerative diseases such as Alzheimer's disease or vascular dementia.
2. Psychiatric illness which is not well controlled.
3. Alcohol withdrawal symptoms/concern for withdrawal.
4. Suspected or confirmed drug intoxication/overdose
5. Traumatic brain injury, ischemic or hemorrhagic cerebrovascular accident, or undergoing neurosurgery.
6. Uncorrected hearing or vision impairment including legal blindness.
7. Incarcerated at the time of study enrollment.
8. Enrolled in another clinical trial which does not permit co-enrollment.
9. Any medical condition precluding safe use of headphones such as: skin breakdown, burns, facial or skull fractures.