cyrilzakka/clinical-trials huggingface dataset:
Reliability of Hertel Exophthalmometer Measurements

The purpose of this research study is to learn about the variability in proptosis measurements. Measurements will be recorded using the Hertel exophthalmometer. This noninvasive tool is an instrument designed to measure the forward protrusion of the eye and may be used normally during a general eye exam. This instrument provides a method of evaluating and recording the progression and regression of the prominence of an eye caused by disorders such as thyroid disease and tumors of the orbit.

Aim 1. In order to determine intrauser reliability of the Hertel exophthalmometer, patients will have 2 independent exams using the Hertel exophthalmometer on the same day performed by each of the same researcher (either DAC or HLP) in a blinded fashion. For each patient, we will independently measure the base value and the values for the right and left eye proptosis, respectively, using the same Hertel exophthalmometer. A randomization process will be employed to determine which researcher (either DAC or HLP) will take the first set of measurements. The distance of the observer from the patient will be standardized for all measurements. Patient research data will be de-identified and recorded for each patient and subsequently analyzed for interobserver reliability.

Aim 2. In order to determine interuser reliability of the Hertel exophthalmometer, patients will have a second independent exam on the same day by the second observer as determined for Aim 1 above. For each patient, we will independently measure the base value and the values for the right and left eye proptosis, respectively, using the same Hertel exophthalmometer. The distance of the observer from the patient will be standardized for all measurements.

Patient research data will be de-identified and recorded for each patient and subsequently analyzed for interobserver reliability.

Aim 3. Variability in Hertel measurements may be related in large part to differences in the base measurement. The base measurement is determined by the bony orbital structures and should not be significantly affected over time by the soft tissue remodeling commonly seen in TED and most other orbital disease processes. We will have the second observer re-measure the same patient using the same Hertel exophthalmometer by beginning with the same base measurement determined by the first observer. Again, all measurement distances will be standardized. No other information will be provided to the second observer other than the beginning base measurement. Patient research data will again be de-identified prior to recording the information and subsequently analyzed to determine if beginning with the same base improves interobserver reliability.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be at least 18 years old and will be able to converse in written and spoken English.

Exclusion Criteria:

* None
Medtronic Cardiac Surgery PMCF Registry

This registry is being conducted to support ongoing post-market surveillance activities.


Eligibility Criteria:
Inclusion Criteria:

1. Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
2. Patient has or is intended to receive or be treated with an eligible product
3. Patient is within enrollment window of treatment/therapy received at the time of their initial Registry enrollment, or meets criteria for retrospective enrollment

Exclusion Criteria:

1. Patient who is, or is expected to be, inaccessible for follow-up
2. Patient prohibited from participation by local law
3. Patient is currently enrolled in or plans to enroll in any concurrent investigational drug and/or device study that may confound results
Understanding How Ketamine Brings About Rapid Improvement in OCD

The purpose of this study is to understand how ketamine brings about rapid improvement in Obsessive-Compulsive Disorder (OCD) symptoms.

Obsessive-Compulsive Disorder (OCD) is a chronic and disabling disorder that costs the economy over $2 billion annually and represents a significant public health problem. This study aims to build on our discovery that a potent NMDA receptor antagonist, ketamine, has rapid (in hours) and robust therapeutic effects in OCD. The proposed projects test the acute mechanism of action of ketamine at the level of molecules, circuits, and network synchrony to determine how NMDA receptor antagonism modifies the underlying pathology of OCD to relieve repetitive thoughts and behaviors.

Eligibility Criteria:
Inclusion Criteria for participants with OCD:

* age 18-65
* Primary diagnosis of OCD
* Sufficient severity of OCD symptoms
* ability to tolerate a treatment-free period
* capacity to provide informed consent

Inclusion criteria for healthy controls:

* ages 18-65
* capacity to provide informed consent

Exclusion criteria for participants with OCD:

* Psychiatric or medical conditions that make participation unsafe
* pregnant or nursing females
* concurrent use of any medications that might increase the risk of participation (e.g. drug interactions)
* presence of metallic device or dental braces

Exclusion criteria for healthy controls:

* any current or lifetime psychiatric diagnosis
* pregnant or nursing females
* major medical or neurological problem
* presence of metallic device or dental braces
PEC Block II in Mammoplasty Surgeries

Breast augmentation surgery is the top cosmetic surgery in USA with more then 300.000 cases performed annually. Pain is a common complications of the procedure accompanied of dyspnea and nausea due to the surgical manipulation.

Several anesthetic techniques were developed with the objective of providing optimal surgical conditions together with enhanced recovery and post-op pain management.

Pectoralis major block was first described in 2011 by Blanco in female patients undergoing oncologic procedures in the anterior thoracic wall.

The investigators hypothesized if the Pectoralis Major block combined with general anesthesia standard techniques could be beneficial in improving pain scores and opioid consumption during post operative period of patients undergoing breast augmentation surgery.

Patients undergoing Breast Augmentation Mammoplasty were submitted to laryngeal mask placement after anesthetic induction with Fentanyl 3ucg/kg , Propofol 2mg/kg and Atracurium 0,5mg/kg and surgery was performed under standard surgical practices.

Before the surgical incision patients were randomized either to receive a Bilateral Pectoralis Major Block(PEC I and II) with Bupivacaine 0,25% with Epinephrine or to receive a placebo block with Normal Saline 0,9%.

After the procedure all patients received a intravenous patient-controlled-analgesia pump device with morphine.

Pain and opioid consumption were assessed with a pain score assessment tool and assessment of the pump administration dosage history.

No NSAIDs or alpha 2 agonist drugs were administered during or after the procedure.

The maintenance of anesthesia was performed with Propofol and Remifentanil Total intravenous anesthesia(TIVA) models in a standardized fashion. Micromanagement of anesthetic drugs was performed by the assistant anesthesiologist physician.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Above 18 years old
* Elective Surgery
* American Society of Anesthesia(ASA) Class I up to III

Exclusion Criteria:

* Pregnancy
* Acute Coronary Syndrome
* History of Arrhythmia
* Functional Class New York Heart Association(NYHA) III or IV
* Previous thoracic/breast surgery
* History of Chronic Pain
* Neuromuscular disease
AcrySof Toric Clinical Results

This study is an evaluation of visual outcomes of subjects implanted with the AcrySof Toric Intraocular Lenses (IOLs) Models SN60T3, SN60T4, and SN60T5.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cataracts; has astigmatism falling in range of AcrySof Toric lens as assessed by the AcrySof Toric calculator

Exclusion Criteria:

* Ocular comorbidities affecting visual outcome data,
* Prior refractive surgery,
* Irregular astigmatism
Wound Closure After Total Knee Arthroplasty: Comparison of Polypropylene and Polyglactin 910 Suture.

Comparison of wound complication and scar formation in patient undergone bilateral total knee replacement comparison between polypropylene and polyglactin 910 suture. patient randomised according to SNOS protocol into group A and B for their right and left knee closure with each suture. patient followed on 3rd, 7th, 15th and 30th post operative day for wound healing, wound dehiscence and scar formation.

All patients aged 50-80 years, belonging to either sex, diagnosed with end-stage osteoarthritis or post-traumatic arthritis, and scheduled for bilateral primary total knee arthroplasty at the Department of Orthopedics, Indus Hospital and Health Network, Karachi were enrolled in the study. Exclusion criteria included patients having existing skin, neuromuscular, or connective tissue disorders, rheumatoid arthritis, immunosuppression, morbid obesity, and pregnancy. All patients provided voluntary informed written consent before enrolment in the study.

In all patients undergoing primary TKA, one knee was closed using polypropylene, whereas the other was closed with Polyglactin 910 sutures. All surgeries were performed by the same surgical team using a standard medial parapatellar approach. The number of sutures and wound closure techniques were standardized across both groups.

Eligibility Criteria:
Inclusion Criteria:

* Age 50 to 80 years
* Both gender
* Inform consent
* End stage osteoarthritis

Exclusion Criteria:

* Age less the 50 and more then 80
* BMI more then 40
* Rheumatoid Arthritis
* lack of consent
* Pregnant female
Development and Evaluation of a ChlorHexidine Gluconate bAthing pRotocol for Healthcare Settings in Low- and Middle-income Countries

The overall goal of the ChlorHexidine gluconate (CHG) bAthing pRotocol for healthcare settings in low- and Middle-income countries (CHARM) study is to explore the safety, efficacy and feasibility of utilizing a locally prepared CHG solution and bathing protocol among hospitalized neonates to reduce bacterial colonization and healthcare-associated infection (HAI) burden in hospitalized patients.

Neonatal sepsis is the third most common cause of neonatal deaths and multidrug-resistant Gram-negative bacteria are now the leading cause of sepsis among hospitalized neonates in south Asia and sub-Saharan Africa, including Botswana. Multidrug-Resistant Organism (MDRO) colonization is thought to precede infection, meaning that pathogens usually are transferred to the skin or intestinal mucosa where they live prior to translocating to the bloodstream or other sterile body compartments, triggering an inflammatory response recognized as clinical sepsis. Colonization is established through direct or indirect contact between a patient and a reservoir that harbors the pathogen.

Multidisciplinary infection prevention and control (IPC) practices can reduce the risk of neonatal MDRO colonization, but once colonized, newborns run the risk of acquiring a serious infection with a difficult-to-treat organism. The use of ancillary IPC measures, including chlorhexidine gluconate (CHG) bathing, has been studied as a de-colonization measure among hospitalized patients. CHG bathing is widely used in Intensive Care Units (ICUs) across high-income countries to reduce bacterial colonization with pathogens, and is being used more frequently in Neonatal Units (NNUs) in low and middle-income countries (LMICs) as a sepsis prevention measure.

The investigators of the CHARM study have developed a protocol to accomplish the following goals:

1. develop a low-cost, standardized protocol for CHG bathing in the ICU and NNU
2. assess safety of local CHG preparation among hospitalized neonates
3. determine the efficacy of CHG bathing using the developed protocol to reduce bacterial colonization and healthcare-associated infection (HAI) burden in hospitalized patients
4. to assess the feasibility and acceptability of CHG bathing among staff and caregivers

The investigators will utilize a mixed methods study involving both a prospective interventional cohort study following approximately 240 neonates, and qualitative interviews of 10 caregivers and 20 healthcare workers in the NNU and ICU.

Eligibility Criteria:
Inclusion Criteria:

* Neonates 1-6 days old admitted to the neo-natal unit expected to stay at least 7 days

Exclusion Criteria:

* Patients with a current weight of \<1kg
* Patients with a current corrected gestational age of \<28 weeks (by Ballard score, or by dates if Ballard is not done)
* Patients with a current diagnosis of hypothermia
* Patients with a current diagnosis of skin rash or skin injury
Pilot Psychoeducational Intervention Model to Improve Nutritional Status in Low Resource Settings

The purpose of this study is to develop, implement and evaluate a psychoeducational intervention focused to improve nutritional status, specifically micronutrients, of mothers and caregivers of children between the ages of 5 and 13 years and their children through providing healthy cooking lessons in their communities.

Mexico's malnutrition problem goes beyond lack of food. Nutrition transition in our country has modified dietary patterns in a way that now we observe more and more a decrease in consumption of micronutrient rich foods, like vegetables, and an increase in consumption of high energy-dense foods with low content of micronutrients (highly processed foods). In Mexico, over 70% of the population presents an inadequate vegetable intake, with a higher prevalence in scholars (5 - 11 years), where only 17% of them consume \>50% of the recommended vegetable intake. A vegetable poor diet is related to malnutrition, poor cognitive development and low physical performance. Added to this, Mexican families have lost the tradition of cooking at home. It is well known that different factors contribute to a population's diet and cooking at home as well as eating with the family have been identified as fundamental factors to promote a healthy diet. Therefore, the aim of this psychoeducational intervention in nutrition is to improve nutritional status in families, particularly mothers and caregivers of children between the ages of 5 and 13 years and their children through providing healthy cooking lessons in their communities where the optimal preparation and use of local foods based on vegetables is promoted at the same time the importance of cooking at home and eating as a family is highlighted.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 60 years
* Premenopausal
* BMI \< 45 during enrollment
* Apparently healthy
* With a child in her care between the ages of 5 and 13 years

Exclusion Criteria:

* Pregnant or breastfeeding
* With a hysterectomy in the past 3 months
* Alcohol consumption \> 14 drinks a week
* Use of vitamin supplements
Relationship Between Cardiopulmonary Exercise Testing and Ca-P in Chronic Kidney Disease (CKD)

Reductions in exercise capacity associated with exercise intolerance augment cardiovascular disease risk and predict mortality in chronic kidney disease. This study utilized cardiopulmonary exercise testing to (a) investigate mechanisms of exercise intolerance; (b) unmask subclinical ca and p and vitamin D abnormalities that may precede cardiovascular disease in chronic kidney disease.

Cardiopulmonary exercise testing will carry out in Stage 3-5 chronic kidney disease patients ; estimated glomerular filtration rate \<60 ml/min/1.73 m2) and biochemistry will be added (Ca P Via D PTH FGF23).

Eligibility Criteria:
Inclusion Criteria:

* CKD Patients with GFR \<60 non-dialysis
* age\<18

Exclusion Criteria:

* HTN
* not signing consent
* active coronary disease
Irreparable Rotator Cuff Tears Treatment. Comparison of Two Methods: With and Without Biceps Tendon Augmentation

Management of massive rotator cuff tears (MRCT) is associated with high rates of failure. The long head of the biceps tendon augmentation (LHBTA) by reinforcement of the reconstruction and additional blood supply may improve healing and provide better outcome than partial repair only.

Patients with irreparable supraspinatus muscle (SSP) tear, and complete infraspinatus muscle (ISP) tear are including in the prospective, comparative study. Excluding criteria consist of: problems or previous surgery of contralateral shoulder, subscapularis muscle tear larger than stage 2 by Lafosse classification, uncontrolled diabetes and previous surgery. First group consisting of patients treated by partial cuff repair with LHBTA. Second group is comparative group consisting of patients treated by only partial cuff repair without LHBTA. Group stratification depends on quality of the biceps tendon. In case of good tendon quality - its used for biological augmentation, if it's degenerated- tenotomy of the tendon and only partial repair is performing. Irreparability is defined as SSP ≥ 3 in Goutallier classification and stage 3 in Patte classification what is preoperatively assessed by MRI. Assessment tools consisting of range of motion (ROM), strength measurements in position adequate to assess reconstructing tendons and muscles force, Acromio-humeral index (AHI), Constant, SST, Hamada, and Sugaya scores. Goutallier classification for SSP and ISP and diameter of the teres minor muscle (TMn). Radiological and clinical assessment is performing one year after the surgery

Eligibility Criteria:
Inclusion Criteria:

Massive and irreparable rotator cuff tear:

* chronic supraspinatus tear with retraction grade 3 and muscle fatty infiltration ( measured in MRI ) \> 3\*
* Infraspinatus tear with retraction and fatty muscle degeneration

Exclusion Criteria:

* Previosus surgery
* Imposibility to performed MRI
* Diabetes
* no compliance
Intra-epidermal Stimulation (IES) of Small Nerve Fibers (A-delta Fibers)

The purpose of the study is to determine whether a particular type of nerve fibers, A-delta fibers, can be tested in an Electromyography (EMG) lab on a routine basis. Normal, healthy volunteers will be enrolled in this study.

The epidermis is the outermost layer of the skin that includes skin cells and small nerve fibers called A-delta fibers. A-delta fibers send signals to the brain about pin-prick type of pain and temperature. The investigators want to study whether the investigators can stimulate A-delta fibers and document this by recording electrical potentials from the nerves in subjects' limbs.

Study Procedures:

A small piece of plastic will be applied to your foot and your hand. A tiny sharp tip protrudes from this piece of plastic. You will be barely able to feel this sharp tip when touching the piece of plastic. This is the electrode for intra-epidermal stimulation.

With stimulation, you will feel a pin-prick type of sensation. The stimulus will be adjusted so that you barely feel the pin-prick type of sensation. The investigators will record responses of stimulation from nerves in your skin.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 21 through 60 years with no history or clinical signs of neuropathy.

Exclusion Criteria:

1. History of peripheral nerve disease or disease of somatosensory pathways.
2. Abnormalities on neurologic examination.
3. Prior or current exposure to known neurotoxins, such as excessive alcohol use or chemotherapy.
4. Neurologic or psychiatric conditions that would prevent the subject from being able to cooperate with testing.
Diabetes Education and A1c Study

Sleep problems are associated with poor blood glucose control, but current diabetes self-management programs do not include sleep education. This study will randomize participants into two groups: one that receives sleep education and one that does not. The researchers expect both groups to experience reductions in blood glucose. The researchers hypothesize that individuals who receive sleep education as part of their diabetes self-management training will experience greater improvements in blood glucose control, as measured by hemoglobin A1c, compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with a diagnosis of type 2 diabetes who are patients at the Michigan State University (MSU) Endocrinology clinic,
* a diagnosis of overweight or obesity (Body Mass Index greater than or equal to 25.0 kg/m2),
* the most recent hemoglobin A1c value greater than or equal to 7.5%, and
* the ability to attend online program sessions.

Exclusion Criteria:

* significant psychiatric disorders,
* advanced medical conditions that require alterations to the MNT for DM2, e.g., advanced chronic kidney disease, and
* an inability to follow recommendations due to cognitive deficits.
Activity To Improve Outcomes in Peripheral Arterial Disease

Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) in the legs and decreased blood flow to the legs. This may cause difficulty or pain with walking or other activities that use leg muscles. Exercise may help improve blood flow in the legs and improve the ability to walk. This research project is being implemented in adults with PAD to examine the effects of exercise or weight loss programs on lower extremity blood flow, health, and physical function.

This pilot study seeks to gather data on different exercise interventions in PAD. Collectively, the proposed studies will gather data on the role of novel exercise interventions in those with PAD who are receiving conservative treatment as well as those who have undergone an endovascular intervention for lower extremity arterial disease.

We hypothesize that patients who undergo an exercise intervention will: A) show improved lower extremity perfusion and B) improve their functional ability, compared to a standard care control group over 6 months of follow-up. We further hypothesize that these improvements are mediated through angiogenesis and increased perfusion of the lower limb, as well as improvements in muscle strength, mass, and function.

Eligibility Criteria:
Inclusion Criteria:

* Age 21-90 years
* Ankle brachial index \< 0.9

Exclusion Criteria:

* Cancer under active treatment, except prostate, skin, and hematologic cancers
* Planned for open lower extremity bypass surgery
* Body mass index \>45
* Lower extremity gangrene
A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus

This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of oral GK Activator (2), compared to placebo, in patients with type 2 diabetes mellitus. The anticipated time on study treatment is less than 3 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients 30-75 years of age;
* type 2 diabetes mellitus for \>3 months before screening;
* treatment-naive, inadequately controlled diabetes despite diet and exercise, or inadequately controlled diabetes in patients on monotherapy or combination therapy (maximum of 2 oral anti-hyperglycemic medications).

Exclusion Criteria:

* type 1 diabetes mellitus;
* women who are pregnant, breast-feeding or not using adequate contraceptive methods.