cyrilzakka/clinical-trials huggingface dataset:
Glucose Clamp Study to Prove Hypo- and Hyperglycemic Episodes Using a Non-invasive Glucose Monitoring Device

Continuous monitoring of the skin tissue glucose concentration on two different study days using glucose sensors that work on the principle of impedance spectroscopy, with systematic alteration of the blood glucose concentration using the glucose clamp technique in healthy subjects and subjects with type 1 diabetes. Simultaneous determination of electrolyte concentrations in the blood by taking frequent blood samples.

A completely non-invasive continuous glucose monitoring device is considered as a major target of glucose sensor development. The aim of this study is to evaluate the performance of a non-invasive glucose sensor (wristwatch) under controlled conditions (glucose clamp) at hyperglycemia (study day 1) and at hypoglycemia (study day 2). Measurements of the non-invasive glucose monitoring device are compared to those obtained from a minimally invasive glucose monitoring device (GlucoDay, microdialysis principle). In addition, changes in blood electrolyte concentrations as well as their impact on the measurements of the non-invasive glucose sensor are evaluated.

Eligibility Criteria:
Inclusion Criteria:

Healthy male and female volunteers:

* Written informed consent
* Aged between 18 and 40 years
* Body mass index between 18 and 28 kg/m²
* Haemoglobin \> 13 g%

Male and female patients with type 1 diabetes:

* Known type 1 diabetes, first manifestation 6 months to 15 years before the start of the study
* HbA1c \<= 9%
* Written informed consent
* Aged between 18 and 40 years
* Body mass index between 18 and 28 kg/m²
* Haemoglobin \> 13 g%

Exclusion Criteria:

* Uncontrolled arterial hypertension (diastolic blood pressure \>100 mmHg and/or systolic blood pressure \> 180 mmHg)
* For women, pregnancy or breast-feeding or, for sexually active women of child-bearing age, the use of contraceptive methods considered to be safe (oral contraceptives, IUD, implanted or injected contraceptives, diaphragms, or surgical sterilisation of the patient or her partner)
* Deviations in the lab values (excluding HbA1c), as judged by the investigator to be clinically significant, in particular an increase in transaminases to a level that is two and a half times higher than the upper normal value and a creatinine value that is above the normal range
* Severe acute diseases, as judged by the investigator
* Severe chronic disease, as judged by the investigator
* History of macrovascular illnesses such as pAVK, myocardial infarction
* Known microvascular (diabetic) complications (other than diabetic background retinopathy)
* Positive serology for hepatitis B, hepatitis C or HIV
* Blood donation within 3 months prior to the start of the study and intention of donating blood within 3 months after the end of the study
Safety, Tolerance, Efficacy and Pharmacokinetics of Multiple Doses of sCD4-PE40 in the Treatment of HIV-Infected Individuals

To investigate the safety and tolerance of an increasing number of infusions per week of alvircept sudotox ( sCD4-PE40; soluble CD4-Pseudomonas exotoxin ) at a fixed dose when administered to HIV-1-infected individuals. To investigate the effect of sCD4-PE40 on the following parameters: T lymphocyte subsets, plasma HIV RNA and cellular HIV proviral DNA in PBMC and CD4 cells, p24 levels, serum beta-2 microglobulin, and neopterin levels.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV positivity confirmed by Western blot.
* CD4 count of 100 - 500 cells/mm3 on a morning draw within 3 weeks prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Concurrent neoplasms other than basal cell carcinoma of the skin, in situ carcinoma of the cervix, or nondisseminated Kaposi's sarcoma.
* Hemophilia or other clotting disorders.
* Major organ allograft.
* Significant cardiac, hepatic, renal, or CNS disease.

Prior Medication:

Excluded:

* Antiretroviral agents within 2 months prior to study entry.
* Known anti-HIV medication within 60 days prior to study entry.
* Prior immunomodulators (e.g., systemic steroids, interferons, or interleukins) or other chemotherapy.

Prior Treatment:

Excluded:

* Prior radiation therapy. Active substance abuse.
(Gastrografin Use in Small Bowel Obstruction Caused by Adherences)

Adhesive small intestine obstruction (ASIO) is an important cause of hospital admission and a very common disease. Any improvement in this field will benefit many patients by reducing the operative rate. Patients with this disease are difficult to evaluate and to manage and their treatment is controversial. Emergency surgery is mandatory when strangulation is suspected or in the case of total obstruction. On the other hand, conservative non-operative treatment is indicated in the case of partial obstruction. The role of water-soluble contrast medium (Gastrografin®: GG) in ASIO is still debated with regard to the therapeutic value.

The aim of our study was to determine the therapeutic role of Gastrografin in patients with small intestine obstruction without strangulation caused by adherences (ASIO).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years)
* History of previous abdominal surgical procedures
* Clinical and radiological evidence of adhesive small intestine obstruction without signs of strangulation and peritonism
* ASA I-III patients
* Informed consent

Exclusion Criteria:

* Suspicion of strangulation
* Actual presence or high suspicion of intra-abdominal malignancy
* Suspicion or history of peritoneal carcinomatosis
* active inflammatory bowel disease
* Positive history of radiotherapy on the abdominal region
* Obstructed hernias
Prevalence of Major Vessels Underlying the Potential Incision Site for Emergency Front of Neck Airway Access in Adult Surgical Patients With Impalpable Neck Anatomy

Patients undergoing general anesthesia require assistance with their breathing and with the delivery of oxygen to their lungs. To achieve this, an anesthesiologist inserts a type of plastic breathing tube into the airway via the mouth called an endotracheal tube or laryngeal mask airway. In rare circumstances, the anesthesiologist may not be able to adequately provide oxygen via these methods. In this life-threatening situation, an anesthesiologist may be forced to make an incision in the front of the neck to access the trachea (windpipe) so that emergency oxygen can be provided. This life-saving technique is known as emergency front-of-neck access (eFONA) and is used to prevent low oxygen levels which cause irreversible brain damage and/or death.

This rarely performed procedure carries a risk of harm from bleeding, injury to the airway or inability to access the trachea to provide oxygen. Emergency front of neck access is more likely to be required in patients with abnormal airway anatomy, for example, in patients with obesity and large neck circumference, neck cancer, or a history of head and neck radiation therapy. Though the optimal technique for eFONA is not clear, prominent guidelines advise the use of an 8-10cm incision upwards from the top of the breastbone in order to identify airway structures which cannot be easily felt by the anesthesiologist from the front of the intact neck. This differs from patients who have airway structures which may be easily located at the front of the neck, whereby a smaller incision may be made or a needle inserted into the trachea (widepipe) to provide oxygen. The neck contains major blood vessels which lie close to the airway and these blood vessels may be injured during the 8-10cm incision, creating further difficulty accessing the airway to provide life-saving oxygen.

This study aims to assess for the presence and size of major blood vessels which may be damaged by this incision by using non-invasive ultrasound which will be placed on the skin of your neck to assess for such blood vessels prior to you undergoing anesthesia.

Our study aims to assess the normal anatomy in the adult population such as yourself to understand what to expect when managing patients who require this life-saving therapy.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Ability to understand the rationale of the study assessments and to provide signed consent
* Ability to safely and comfortably take part in the study protocol

Exclusion Criteria:

* Participant refusal
* Participant less than 18 years old or older than 80 years old
* Participants who do not speak English or cannot give informed written consent without assistance
A Study to Characterize the Phenotype in Patients With Morton's Neuroma and to Explore the Effect of Local Administration of Xylocaine (Lidocaine)

To characterize the phenotype in patients with Morton's neuroma and to explore the effect of local administration of Xylocaine (lidocaine)

A randomised, double-blind, placebo-controlled, three-way cross-over single center study to characterize the phenotype in patients with Morton's Neuroma and to explore the effect of local administration of Xylocaine (lidocaine)

Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical diagnosis of Morton's neuroma with symptoms of at least 3 months duration in one foot (affected foot)
* Visual analogue scale (VAS) pain-score of = 40 mm in the painful foot at daily activities during the previous week (visit 1)

Exclusion Criteria:

* Allergy to lidocaine
* Scars or other dermal conditions on the feet that may interfere with study procedures
Providing Cancer Care Closer to Home for Patients With Multiple Myeloma

There is very limited data on the utilization of National Cancer Institute Comprehensive Cancer Center (NCI-CCC) satellite sites in general. Of what is available, most is in regards to providing chemotherapy at facilities closer to patients' home. These "satellite chemotherapy infusion centers", typically community-based treatment locations at community hospitals/facilities, freestanding clinics, or mobile units, are reported to be well liked by patients who utilize their services and reduce their travel times and expenses. In these studies patients still remained in the care of their current provider and site and are required to travel to the site for clinical visits and other appointments. It is currently unknown if patients are willing to transfer their care to a different provider to alleviate travel burden. In addition, although increased travel burden has been lower quality of life in cross-sectional studies, no data exists suggesting that these reducing travel burden can improve these outcomes intra-patient, to the knowledge of the investigators.

The patient roles of the multiple myeloma clinical providers at the Siteman primary location have grown in recent years. The providers have determined a need to refer some patients to the satellite sites to relieve congestion at the site while also hopefully improving the clinical experience for those patients. This study is a natural experiment of this process.


Eligibility Criteria:
Eligibility Criteria

* At least 18 years old
* Diagnosed with multiple myeloma
* Receiving care from a provider within the Division of Oncology at the primary Siteman Cancer Center site
* Resides within the catchment area of a Siteman Cancer Center satellite site
* Able to read, speak, and understand English
* Willing to provide informed consent
Use of Recombinant Hyaluronidase Human is Effective for the Use of Local Blocks for Eyelid's Surgery

To evaluate the use of recombinant hyaluronidase (rHuPH20) as an adjunctive for local anaesthesia, lidocaine 2% with epinephrine 1:100000, for eyelid surgery.

Subjects scheduled for bilateral upper eyelid surgery will be recruited from among the patients of the Duke Eye Center. After consent is obtained following full explanation of the research, subjects will be randomly assigned (1:1 ratio) on the day of the surgery to receive local anaesthesia by either with recombinant hyaluronidase (rHuPH20) or without it. Approximately 2 ml of prepared block will be infiltrated in both upper eyelids.

Dilutions (Blocks):

A) 0.5 mL of lidocaine 2% with epinephrine 1:100,000 and 0.5 mL of marcaine 0.75% and 1 mL (150 U) of rHuPH20 for a total of 75 U/ml B) 2 mL of lidocaine 2% with epinephrine 1:100,000 without rHuPH20

Test preparation will be applied subcutaneously in both upper eyelids by injection using a 30-gauge injection needle with the patient in supine position. Every patient will be injected by the same Oculoplastic surgeon.

A Pinprick pain test will be perform 5 minutes after each injection using a sterile "finger stick" needle at three sites of each upper eyelid. These sites include medial, central and lateral portion of each eyelid, approximately 4 mm above the lid margin. The subject will be asked to rate the degree of pain experienced at each site on a scale from 0 (none) to 10 (severe). An average pain score will be calculated for each eyelid. This will help determine if one of the 2 dilutions have a faster anaesthetic effect.

Patients will also be instructed to inform the surgeon of precisely when the pain began and subsided to accurately record the duration of the pain experienced.

Eligibility Criteria:
* Inclusion Criteria:
* Capable and willing to provide consent
* Has been scheduled for bilateral upper eyelid surgery
* At least 18 years of age
* Exclusion Criteria:
* Unable or unwilling to give consent
* Previous upper eyelid surgery
* Under 18 years of age
Diurnal Curves With Bimatoprost 0.03% Versus Travoprost 0.004%

To compare the diurnal curves in patients using bimatoprost 0.03% versus travoprost 0.004% for the treatment of glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* · Male or female \> 18 years of age

  * Naive to treatment or washed off any ocular hypotensive agents
  * Untreated IOP \>19 mm Hg
  * Diagnosis of open-angle glaucoma or ocular hypertension
  * Ability to provide informed consent and likely to complete study

Exclusion Criteria:

* · Known contraindication to bimatoprost or travoprost, or any component of any study medication

  * Uncontrolled systemic disease
  * Active ocular disease other than glaucoma or ocular hypertension
  * Required use of ocular medications other than the study medications during the study
  * History of intraocular surgery within the last 3 months
  * Prior discontinuation of any of the study medications for reasons related to efficacy or safety
Repetitive Transcranial Magnetic Stimulation Associated With Manual Therapy in Knee Ostearthritis Pain

In this study, the investigators wondered whether the association between high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and manual therapy (peripheral and central approach) is more effective in reducing pain levels and modulation of cortical activity of chronic knee ostearthritis pain subjects than manual therapy alone (usual peripheral approach). For this purpose, patients included will be submitted to one session with active or sham hf-rTMS followed by a protocol of manual therapy. Besides that another active group will have the sequence of interventions exchanged (manual therapy followed by hf-rTMS) in order to investigate whether this may influence in the final outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of knee OA;
* Absence of severe cognitive deficiency verified by the Mini Mental State Examination;
* Meet the American College of Rheumatology criteria for idiopathic knee osteoarthritis.

Exclusion Criteria:

* Individuals diagnosed with osteoporosis, fibromyalgia or other neurological disease;
* Had an opioid or corticosteroid injection in the last 30 days;
* Modified chronic pain medication in the last month before participating in the study;
* History of knee surgery in the last six months;
* Obese;
* Contraindications to the use of non-invasive brain stimulation, such as: metal implant on face or skull, history of seizure, cochlear implant.
Low Intensity ShockWave Therapy for ED in Non Responders to PDE5i - a Double Blind Placebo Controlled Study

Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of new blood vessels. The investigators hypothesized that LISW therapy could improve the symptoms of patients with erectile dysfunction resulting from a problem of blood supply that do not respond to oral therapy (PDE-5 inhibitors).

In this study Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered directly to the penile tissue using a specially designed shockwave device and probe. Shock wave therapy is applied twice a week for three weeks , then a 3- week interval with no therapy followed by another 3 week period of twice a week shock wave therapy. Before and after sexual function questionnaires and objective measures of erectile function will be performed.

Eligibility Criteria:
Inclusion Criteria:

* ED of more than 6 months
* Rigidity score \< 3 during PDE5i therapy
* SHIM \<21 during PDE5i therapy
* Non- hormonal, neurological or psychological pathology Stable heterosexual relationship for more than 3 months

Exclusion Criteria:

* Prior prostatectomy surgery
* Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
* Clinically significant chronic hematological disease
* Anti-androgens, oral or injectable androgens
* Radiotherapy in pelvic region
The Effects of Dry Needling on Patients with Knee Pain

This study is testing the effectiveness of "dry needling" for pain management and on muscle strength and leg function for those with knee pain. Dry needling consists of small, monofilament needles that are administered directly into the tissue and manipulated to make the muscle relax for pain relief. This technique is used to treat dysfunctions in skeletal muscle and connective tissue to help diminish pain, reduce impairments of body structure and restore function.

This project will evaluate the effects of dry needling on pain, muscle performance, and function in those with patellofemoral pain syndrome (PFPS) of the knee. Variables of interest will include self-reported pain scores, self-reported functional outcome and disability questionnaire scores, and various objective clinical measures including muscle strength, joint range of motion, and movement patterns during basic tasks related to activities of daily living. Patients who are referred to physical therapy with PFPS will be recruited. Patients will be randomly and equally allocated into one of the following groups: 1. Gluteal dry needling (GLUTE) 2. Quadriceps dry needling (QUAD) 3. Sham gluteal dry needling (SHAM GLUTE) 4. Sham quadriceps dry needling (SHAM QUAD) 5. Control group (CONTROL) Groups 1-4 will receive 2 sessions of dry needling or sham dry needling to the gluteal and/or quadricpes muscles on their painful lower limb over 2 consecutive weeks in addition to standard physical therapy. The CONTROL group will only receive standard physical therapy. The sham treatment groups (groups 3-4) will receive a placebo treatment that does not penetrate the skin or muscles. Measurements will be performed at baseline prior to any physical therapy interventions and then at week 3.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years-of-age
* Referred for physical therapy
* Presence of anterior knee pain around the patella during ascending/descending stairs, squatting, and/or running for at least 3 months.

Exclusion Criteria:

* Unable to provide consent
* Bilateral patellofemoral pain syndrome
* Received previous dry needling treatments
* Pregnancy
* History of pain less than 3 months
* Imaging demonstrating the presence of confounding internal abnormality (e.g. chondral defects, ligamentous injury, and/or meniscal pathology),
* Patellar instability
* Presence of a neurological condition that would affect movement
* Contraindications to dry needling techniques (e.g. a history of bleeding disorders, phobia of needles, an active cancer diagnosis, and presence of other systemic illness such as fever or signs of infection)
* Actively receiving treatment for knee pain outside of the current study protocol while enrolled in the study;
* received active and supervised PT treatment for knee pain within the last 4 weeks;
* history of knee surgery less than 6 months ago
* history of surgical correction of the patellofemoral complex (e.g. MPFL reconstruction, patellar realignment surgery, etc)
Donepezil in Preventing Delirium in Hospitalized Elderly

The purpose of this study is to explore the efficacy of a perioperative daily dose of Donepezil (a cholinergic enhancer) in reducing the incidence and severity of delirium.

Delirium is confusion or a sudden change in alertness which may happen after hip repair surgery. Up to 65% of elderly undergoing surgical repair of hip fracture experience post-operative delirium. These individuals often stay in the hospital longer, have more complications, and are more likely to die. Early studies suggest that delirium could be prevented by correcting the central cholinergic deficit that is associated with delirium. Donepezil is currently being used to treat memory loss in patients with Alzheimer's disease.

This study will recruit 30 adults aged 65 or older who are undergoing hip fracture surgery. Participants will be randomized to receive either Donepezil or a matching placebo within 24 hours prior to surgery and for 4 days after the surgery.

All material to be collected will be from interviews, questionnaires, and medical chart review at baseline and daily for the entire hospital stay. The Confusion Assessment Method (CAM) and Memorial Delirium Assessment Scale (MDAS) will be used to evaluate the effect of Donepezil on delirium incidence and severity. Other assessments include cognitive deficit, length of hospitalization, discharge site, adverse effects, and psychotropic medications.

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling individuals aged 65 or older
* Admitted to Methodist Hospital for surgical repair of hip fracture
* No evidence of delirium at admission to hospital
* MMSE total score below 24 points after adjustment for education and age
* Consent to participate in the study

Exclusion Criteria:

* Severely demented as defined by MMSE score below 10
* Metastatic cancer or other comorbid illnesses likely to reduce life expectancy to under 6 months
* Multiple trauma or pathological fractures
* Aphasic, legally blind, or deaf
* Use of Donepezil or other cholinesterase inhibitors within one month prior to surgery
* Allergy to Donepezil