cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Development of an Advanced, Conformable Prosthetic Socket, Study II

The purpose of this study is to work with prosthetists to fit the novel conformable socket material developed by Infoscitex, to subjects, and determine if it is a viable alternative to current prosthetic socket liners. During this task, the research team will travel to the prosthetists locations to have them fit the subject with the conformable woven socket and a check socket, and provide subjective feedback with regard to comfort and fit for the amputee, its ease of use, and breathability. The subject will also wear the woven socket for gait analysis and provide his/her feedback as well.

Modern prosthetics have improved significantly with regards to control and functionality, but the fit of the residual limb within a prosthetic socket is a primary concern for many amputees. A poor fit can lead to skin irritation, tissue breakdown, and pain. The volume of the residual limb of an amputee changes throughout the course of a day and throughout the year. Volume fluctuation within the socket can lead to issues for the amputee, including decreased comfort, increased shear forces, increased pressure on bony prominences, as well as a poor gait pattern. An uncomfortable or non-performing socket/residual limb interface decreases user compliance with the prosthetic and therefore decreases the activity level of amputees who want to remain active in their civilian and military lives. The investigators are developing a multilayered socket that takes advantage of a novel braided material for strength and passive conformability with thin layers dedicated to wearer comfort. This new socket provides ultimate fit for improvement in the performance of the prosthesis. The socket adapts itself to the changing physical shape of the residual limb as the prosthesis is worn. The adaptation is a natural result of the material properties, so is done passively and in real time. The materials are lightweight, breathable, and ultrasound transparent, allowing the prosthetic to function in a variety of environments.

This study will be undertaken to have prosthetists fit subject lower limb amputees with the woven inner socket, with a check socket for evaluation in a gait lab setting. At the completion, the subject and prosthetists will be asked to complete a questionnaire and give their opinions regarding the material of the woven inner socket.

Eligibility Criteria:
Inclusion Criteria:

* lower limb amputation
* stable residual limb volume
* loss of limb due to trauma
* at least 18 years of age

Exclusion Criteria:

* evidence or history of neuropathy
* presence of phantom limb pain
Repetitive Transcranial Magnetic Stimulation and the Development of Ongoing Muscle Pain

The main purpose of the study is to assess the mechanisms of repeated sessions of repetitive trancranial magnetic stimulation (rTMS) applied on left dorsolateral prefrontal cortex on the development of pain in a prolonged muscle pain model.

This study aims to investigate whether i) rTMS of left DLPFC will reduce the severity and duration of experimentally induced muscle pain when a 5-day course of treatment is given immediately following an initial nerve growth factor (NGF) injection; ii) the analgesic effects of left DLPFC rTMS will be related to an improved cognitive network function as assessed by electroencephalography (EEG).

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Speak and understand English.

Exclusion Criteria:

* Pregnancy
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Previous neurologic, musculoskeletal or mental illnesses
* Lack of ability to cooperate
* History of chronic pain or current acute pain
* Previous experience with rTMS
* Contraindications to rTMS application (history of epilepsy, metal in the head or jaw etc.).
* Failure to pass the "TASS questionnaire" (TASS = Transcranial Magnetic Stimulation Adult Safety Screen)
Retrospective Chart Review Study of Patients Treated With Votiva Device

retrospective data collection is to gain insight into patients satisfaction post Votiva treatments for the complex of vulvovaginal symptoms.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18years of age at the time of the procedure
* patients with symptoms of at least one of the following: vaginal relaxation syndrome, vaginal atrophy, vaginal dryness, dyspareunia, SUI, Vaginal laxity, recurrent UTI, recurrent vaginal infections, Linchen Sclerosis, perineal pain, itchiness.
* At least one Votiva procedure that included FormaV applicator treatment with or without combination with Fractora/Morpheus8 Applicators treatments

Exclusion Criteria:

* active infection, collagen disorders, immunocompromised state, medications that mitigate inflammatory response, and propensity for keloid/hypertrophic scarring.
Diabetes in the Perioperative Period

High blood glucose levels in surgical patients with and without diabetes are associated with increased risk of medical complications and death. Over the short-term, high blood glucose can adversely affect fluid balance, impair immunologic response to infection, and promote inflammation and endothelial dysfunction (blood vessel function). Blood glucose control with intensive insulin therapy in patients with critical illness (very sick patients in intensive care unit) reduces the risk of multiorgan failure and systemic infections, and decreases short- and long-term mortality. High blood glucose has also been associated with poor outcome in non-critically ill patients admitted to general surgical and medical wards; however, intensive glycemic control is not aggressively pursued because of fear of hypoglycemia. A computerized search of biomedical journal literature from MEDLINE, PubMed, and Ovid from 1966 to 2008 provided very little information on the prevalence and outcome of high blood glucose during the perioperative period (before and after surgery) in non-critically ill patients. Therefore, the present study aims to evaluate the impact of high blood glucose, in large number of subjects with and without diabetes, during general (non-cardiac) surgery.

We will perform a retrospective chart review of all patients who underwent non-cardiac surgery from 01/01/07 to 06/30/07 at Emory University Hospital as inpatient.

Eligibility Criteria:
Inclusion Criteria:

* patient undergoing non-cardiac surgery (inpatient only)

Exclusion Criteria:

* outpatient procedures, cardiac surgery
The Reduced Insulinotropic Effect of a Continuous Infusion Relative to a Bolus Injection of GIP

In patients with type 2 diabetes, the incretin hormone glucose-dependent insulinotropic polypeptide (GIP) has lost its insulinotropic activity, but more so after continuous versus bolus administration. The design was a two-way crossover design comparing repeated bolus injection and continuous infusion of GIP under hyperglycaemic clamp conditions. Patients were age- gender- and weight-matched with type 2 diabetes, first degree relatives of such patients, and healthy subjects. Investigators performed a:

1. Oral glucose challenge;
2. hyperglycemic clamp (8.5 mmol/l) with two repeated GIP bolus administrations (50 pmol/kg body weight at 30 and 120 min); and
3. hyperglycemic clamp with continuous administration of GIP (2 pmol.kg-1.min-1 from 30-180 min).

To answer the question, whether rapid tachyphylaxis occurs with regard to the insulinotropic action of GIP, investigators studied type 2-diabetic patients, their first-degree relatives, and healthy controls under hyperglycaemic clamp conditions with two GIP bolus injections 90 min apart, and compared this to a continued intravenous infusion of GIP.


Eligibility Criteria:
Inclusion Criteria:

* Exclusion of pregnancy
* Exclusion of impaired glucose tolerance or type 2 diabetes in metabolical healthy subjects
* current diagnosis of type 2 diabetes according to the guidelines of the German Diabetes Association (DDG) ( Kerner et al . 2001) in subjects of diabetes group
* fasting glucose ≤ 150 mg/dl
* Body-mass-index ≥ 20 kg/m²
* Written consent

Exclusion Criteria:

* Type 1 diabetes
* Impaired glucose tolerance or Type 2 diabetes in metabolical healthy subjects
* Ketone bodies urine diagnostics at least ++
* Acidosis
* Fasting blood glucose \> 150 mg/dl
* Body-mass-index \< 20 kg/m²
* No written consent
* Pregnancy or unsafe contraception in women before menopause
* Active malignancy
* Angina as current, unsolved clinical problem
* Inadequately treated or untreated arterial hypertension ( \> 160 mmHg systolic and / or \> 95 mmHg diastolic )
* Infection / fever \> 37.5 ° C
* Treatment with glucocorticoids
* Insulin therapy within the last three months
* Anemia with a hemoglobin level \< 12 g/dl
* Liver function limitations
* Renal impairment ( serum creatinine \> 1.5 mg/dl )
* Alcohol or drug abuse
* Participation in clinical trials in the last 3 months
* Inability or unwillingness to comply with the requirements of the Protocol
* Known hypersensitivity to GIP
ABLATE Versus PACE: PVI or AV Node Ablation and PM Implantation for Elderly Patients with Persistent AF

As patients age, symptom control and treatment of atrial fibrillation become equally difficult, often leading to increased hospitalization. ABLATE versus PACE is a prospective, randomized clinical trial comparing pacemaker implantation with AV node ablation with pulmonary vein isolation in terms of rehospitalization and quality of life in patients with persistent AF aged 75 years and older.

Atrial fibrillation is the most common cardiac arrhythmia and is a major public and represents a major public health problem with increasing healthcare costs and increased mortality risk.

In case of recurrent symptomatic atrial fibrillation current guidelines recommend pulmonary-vein isolation (PVI) as invasive treatment option. However, 5-year arrhythmia-free survival estimate is 29% after single catheter ablation. Although the long-term success rates in maintaining sinus rhythm are higher than with drug-based rhythm control, they are still moderate, especially in older patients with comorbidities. Therefore, repeated interventions are often necessary.

An effective method for frequency control is atrioventricular (AV) node ablation after implantation of a pacemaker ("ablate-and-pace"). In this case, the ventricular rate is only set by the pacemaker and can be programmed according to the patient's needs.

There are some theoretical disadvantages of this treatment option (pacemaker dependency, reduction of cardiac outpout due to lack of atrial contraction) which is why this method nowadays is almost exclusively used in older (and physically less active) patients.

The ABLATE versus PACE trial is a prospective randomized clinical trial comparing at 196 these two treatment options in terms of rehospitalizations due to cardiovascular causes and quality of life in elderly patients (≥ 75 years) with normal ejection fraction (≥ 50%).

Eligibility Criteria:
Inclusion Criteria:

* Persistent AF according to current ESC guideline (2020)
* Symptoms EHRA classification II - IV despite guideline indicated medical therapy
* Age ≥ 75 years
* Capability of giving written informed consent

Exclusion Criteria:

* impaired systolic left ventricular function (ejection fraction \< 50%)
* High-grade (III°) left cardiac valvular disease
* pre-implanted pacemaker
* bradycardia-indication for pacemaker
* Surgical coronary revascularization (within the last 90 days) or current triple therapy after stent PCI
* contraindication for PVI or pacemaker-implantation
* contraindication for oral anticoagulation
* body-mass-index BMI \> 40 kg/m2
* inability to give written informed consent
* concomitant participation in another registered trial
* life expectancy \< 12 months
* reversible cause of AF (e.g. thyrotoxicosis, alcohol ingestion)
Clinical Study of Ixabepilone (BMS-247550) by Every-3-week Dosing Regimen in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and Who Are Taxane Resistant

The purpose of this study is to determine the response rates for Ixabepilone (BMS-247550) in subjects with metastatic breast cancer previously treated with an anthracycline and who are taxane resistant.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 20 years or older
* Patients with metastatic breast cancer whose primary lesion was definitely diagnosed to be breast by histological or cellular examination

Exclusion Criteria:

* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥ 2
Behavior Analytic Support of Needle-related Hospital Visits for Autistic Patients

The purpose of this study is to evaluate the effectiveness of the behavior analytic intervention in reducing the number of challenging behaviors exhibited by patients with Autism Spectrum Disorder (ASD) while increasing compliance with needle-related simulations and procedures. A second purpose is to assess the social validity of this study as evidenced by patient and/or caregiver acceptability. The study wil take place at Boston Medical Center (BMC).

A Single Subject Design (SSD) wil be utilized as it allows for detailed, individualized assessment of how interventions affect behavior over time in this type of behavior analytic research. By focusing on each participant as an individual and having each participant act as their own control, it demonstrates clear cause-and-effect relationships, showing how behavior changes with the introduction or withdrawal of an intervention. This method is flexible, enabling ongoing adjustments to treatments based on real-time data, making it particularly useful in personalized interventions and ensuring effectiveness for patients with unique needs such as those who would be eligible to enroll and participate in this study.


Eligibility Criteria:
Inclusion Criteria:

* Caregivers of autistic patients who have been historically engaged in challenging behaviors during needle-related procedures at a Boston Medical Center (BMC)
* Established BMC autistic patients (ages 3+) who have a history of engaging in challenging behaviors in the presence of needle-related medical stimuli.
* BMC Medical Providers (i.e., phlebotomists, medical doctors, registered nurses, certified nursing assistants, registered dieticians, and medical assistants) who either: 1) order needle-related medical procedures for participants to be conducted during procedure visits and/or 2) are present to conduct the ordered procedure
* English speaking participants

Exclusion Criteria:

* Patients who are unable to visit BMC a minimum of 2 times per month
* No history of challenging behaviors in medical appointments involving the presentation of needle(s)
* Patients and caregivers who do not speak English or are unable to utilize interpreter services to complete assessments and surveys
Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity

The aim of this study is to investigate the longitudinal efficacy of a potassium nitrate mouthwash formulation when used as an adjunct to brushing with a standard fluoride dentifrice for the relief of dentinal hypersensitivity (DH) compared to brushing with a standard fluoride dentifrice alone. This will be a single centre, eight week, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity Score of the two selected test teeth) study in participants with at least two sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants will be assessed at Baseline, and at four and eight weeks to monitor clinical efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

* Participants in good general health, with self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years.
* Participants with minimum of 20 natural teeth.
* At screening, a minimum of four, non-adjacent teeth.

  1. Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion.
  2. Teeth with Gingival Index score ≤1 and a clinical mobility of ≤1.
  3. Teeth that are determined to be sensitive by the participant following a 1 second air blast to the cervical margin.

Exclusion Criteria:

* Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
* Any condition which, in the opinion of the investigator, causes dry mouth.
* Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening.
* In the 8 weeks prior to screening use of an oral care product indicated for the relief of DH.
Coronary Computed Tomography Angiography and SPECT in Asymptomatic Diabetes

The purpose of this study is to compare the difference of diagnostic efficiency between coronary CT angiography and myocardial perfusion single photon emission computerized tomography in asymptomatic patients with type 2 diabetes mellitus.

Coronary artery disease (CAD) is the leading cause of death in patients with diabetes. Patients with diabetes are known to have silent myocardial ischemia more frequently than those without diabetes. Furthermore, CAD in patients with diabetes frequently manifested in advance stage, and morbidity and mortality are higher than those without diabetes. Early screening and treatment of CAD in asymptomatic patients with diabetes might reduce high morbidity and mortality.

Myocardial perfusion single photon emission computerized tomography (SPECT) is known as a gold standard method in detecting silent myocardial ischemia in asymptomatic patients with diabetes. Despite of the power of detecting myocardial ischemia functionally, there are limitations of SPECT in diagnosing subclinical coronary atherosclerosis anatomically. In recent advance in technology, coronary CT angiography (CTA) could detect subclinical coronary atherosclerosis. However, there is a paucity of information comparing the diagnostic power between SPECT and CTA.

Therefore in our study, we compare the difference of diagnostic efficiency between coronary CT angiography and myocardial perfusion single photon emission computerized tomography in asymptomatic patients with type 2 diabetes mellitus.

In this study, we will recruit asymptomatic patients with diabetes. At the time of enrollment, all patients will undergo two imaging studies (SPECT and CTA) within a few days apart. When patients had positive result in either study, they will undergo coronary angiography for confirmation. We will evaluate the results of two studies comparing with coronary angiography. When the patients are eligible for study, investigators will give information about the study and obtain written consent. The presence of chest pain symptom will be screened with Rose questionnaire. Medical history and physical examination will be performed, and baseline laboratory work-up will be performed. Investigators will evaluate the status of diabetic complication (retinopathy/nephropathy/cardiac autonomic neuropathy).

Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes mellitus
2. Age 50 \~ 75 years
3. Duration of diabetes: more than 5 years
4. More than two of the following risk factors in addition to diabetes:

1)dyslipidemia, 2)hypertension, 3)smoking, 4)family history of premature coronary artery disease

Exclusion Criteria:

1. Angina pectoris or anginal equivalent symptoms
2. Insulin pump user or history of ketoacidosis
3. History of myocardial infarction, heart failure, or coronary revascularization
4. Electrocardiographic evidence of Q-wave myocardial infarction, ischemic ST- segment or T-wave changes, or complete left bundle branch block
5. Uncontrolled arrythmia
6. Hypersensitivity to contrast dye
7. Renal failure
Personalized Multi-peptide Vaccination in Combination With the TLR1/2 Ligand XS15 in Cancer Patients

The aim of this project is to provide personalized multi-peptide vaccination in combination with the TLR1/2 ligand XS15 to individual patients with advanced solid and hematological malignancies without any approved treatment options.

Ethics: Patient treatment will be conducted according to §13 Absatz 2b, AMG.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of advanced malignant disease
* Advanced malignant disease without any available standard of care treatment option
* Low tumor cell burden
* Live expectancy \> 6 month
* Ability to understand and voluntarily sign an informed consent form.
* Ability to adhere to the study visit schedule and other protocol requirements
* Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.

Exclusion Criteria:

* Pregnant or lactating females.
* Treatment regimens inducing sever T cell deficiencies
* Treatment-related side effect \> CTC grade 2 (CTCAE V5.0
* Participation in any clinical study or having taken any investigational therapy, which would interfere with the studys primary and secondary end points within 2 weeks prior to vaccination
* Pre-existing auto-immune disease except for Hashimoto thyroiditis and mild (not requiring immunosuppressive treatment) psoriasis
Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine

Dosage-Escalation Study to Evaluate the Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine in Healthy Adults (18-45 years of age).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female individuals of 18 through 45 years of age on the day of informed consent
2. Healthy volunteers with good physical and mental health status, determined on the basis of the medical history, a physical examination and the results of the screening tests as judged by the investigator
3. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry
4. Individuals who can comply with study procedures including follow-up
5. Individuals that are able to understand, read and write German language
6. Females of childbearing potential who are using an effective birth control method which they intend to use for at least 30 days after the study vaccination.

Exclusion Criteria:

1. Progressive, unstable or uncontrolled clinical conditions
2. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study
3. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws
4. Abnormal function of the immune system
5. Received immunoglobulins or any blood products within 180 days prior to informed consent
6. Received an investigational or non-registered medicinal product within 30 days prior to informed consent or intend to participate in another clinical study at any time during the conduct of this study
7. Vulnerable subjects (e.g. persons kept in detention), study personnel or an immediate family or household member of study personnel, subjects with legal incapacity or limited legal capacity
8. Any relevant deviation from the laboratory parameters at screening as judged by the investigator
9. Previously received any vaccine that included a MenC antigen
10. Previously suspected or confirmed disease caused by N. meningitides
11. Had household contact with and/or intimate exposure to an individual with culture proven MenC
12. A positive serum or urine pregnancy test prior to the study vaccine administration or are currently lactating.
13. A positive drugs-of-abuse test prior to the study vaccine administration;
14. Received any other vaccines within 30 days prior to enrolment in this study or who are planning to receive any vaccine within 30 days from the administration of study vaccines
15. Any other condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.