cyrilzakka/clinical-trials huggingface dataset:
Obesity as a Risk Factor for Musculoskeletal Diseases in the U.S. Air Force: Associations and Implications for Force Readiness

To study the first hypothesis, a retrospective cohort analysis of Air Force members from January 2005 to December 2010 will be performed to evaluate the association of obesity as an independent predictor variable with musculoskeletal disease as the dependent variable.

To study the first hypothesis, a retrospective cohort analysis of Air Force members from January 2005 to December 2010 will be performed to evaluate the association of obesity as an independent predictor variable with musculoskeletal disease as the dependent variable. A second analysis will be performed on the same cohort using musculoskeletal disease as an independent predictor variable, as well as evaluating a potential interaction between obesity and musculoskeletal disease, to determine the association of these variables with the dependent variable of service member readiness for duty. The independent variables for the analyses include:

* Age
* Sex
* BMI
* Fitness data (PIMR: PFT scores, weight, height, BMI, abdominal circumference)
* Profile data (PIMR: Number of profiles, number of profiles due to musculoskeletal diagnoses, total days on duty limitation, total days on mobility limitation)
* Total number of deployments served
* All new musculoskeletal diagnoses (see attached abbreviated ICD-9 list)
* Incidence of member separation from AF
* Incidence of disability retirement
* X-rays
* Surgeries (orthopaedic, general)
* Referrals to the Orthopaedic Department
* Referrals to the Pain Clinic
* New diagnosis of diabetes mellitus
* Death

All data will be gathered by SG6H, Healthcare Informatics Division, and de-identified. Then the de-identified data will be coded and sent to the Principal Investigator for analysis. All informational data sets will be totally de-identified prior to releasing to the Principle Investigator to be analyzed by a statistician.

Eligibility Criteria:
Exclusion: Active Duty Air Force members with the following conditions will be excluded from the study:

* Documented preexisting musculoskeletal injury/disease before onset of obesity
* Hypothyroidism/Hyperthyroidism
* Hyperparathyroidism
* Osteopenia/Osteoporosis
* Nicotine dependence
* Alcohol dependence
* Eating disorders (anorexia nervosa, bulimia nervosa)
* Cancer requiring chemotherapy or radiation therapy
* Status-post gastrectomy
* Status-post bilateral oophorectomy
* Crohn's Disease
* Ulcerative Colitis
* Celiac Disease
* Cushing's Disease
* Prior to or during the study period, more than 6 months of taking proton pump inhibitors, medroxyprogesterone acetate, bisphosphonates, methotrexate, selective serotonin reuptake inhibitors, or inhaled/intranasal corticosteroids
* Prior to or during the study period, more than 1 month of taking fluoroquinolones, oral or intramuscular corticosteroids, oral or intramuscular testosterone, or leuprolide
Serum Antimullerian Hormone Levels in Patients Who Underwent Hayman Suture

From patient charts we will review patients who had undergone cesarean section within the last 6 months and identify those who received a The Hayman uterine compression suture for uterine atony. We will also select patients who delivered a baby without recieving a Hayman suture to create a control group. Patietns will be grouped as Hayman Group if they recevied a Hayman suture during C/S and control group if thay had not recevied a Hayman suture. We will then check patient charts for post-cesarean outpatient clinic visit and select those who received ovarian reserve evaluation via hormones and antral follicle count during the visits. Finally, we are planning to investigate any correlation between Hayman suture and ovarian dysfunction.

Hayman suture is a common technique for uterine compression to stop bleeding due to uterine atony. Hayman described placement of two to four vertical compression sutures from the anterior to posterior uterine wall without hysterectomy. It is usually employed to overcome uterine atoy dıring cesarean section. However, since the technique is relatively new, data on its safety and efficacy arelimited to a few case reports. several complications including cavity obliteration, blood entrapment and infections have been described. However, data regarding the ovarioan function is lacking.

Eligibility Criteria:
Inclusion Criteria:

* age 18- 40 years
* no systemic or endocrine diseases
* patients who had uterine artery ligation due to atony
* healthy postpartum patients as controls

Exclusion Criteria:

* patients with Polyctsitic over syndrome
* Pregnancy with IVF or oocyte donation
* Obese patients
* patients with previous/present endometriosis
Observational Study of the Switch of Metformin Alone to Metformin Combined With Repaglinide in Type 2 Diabetes

This study is conducted in Europe.

The aim of this observational study is to investigate the switch from metformin alone to metformin combined with repaglinide in type 2 diabetic patients not achieving adequate glycaemic control on maximal dose of metformin given alone and to analyse different epidemiological parameters.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients with inadequate glycaemic control when received metformin alone on maximal dose
* Signed informed consent
* Treatment in accordance with the summary of product characterisation

Exclusion Criteria:

* Any contraindication to metformin or repaglinide
HEARS-SLP: Providing SLP-Delivered Hearing Health Care to Individuals With Cognitive Impairment

Building upon the HEARS audiologist-community health worker (CHW) model, this study intervention will be delivered by a speech-language pathologist (SLP). The primary objective of the study is to develop and test an affordable and accessible hearing rehabilitative intervention that will be delivered by a SLP to individuals with cognitive impairment.


Eligibility Criteria:
Inclusion Criteria:

* Age 60 - 100 years old
* English-speaking
* Lives at home
* Diagnosis of probable Alzheimer's Disease or other related dementia according to the core clinical criteria outlined in the National Institute on Aging (NIA) and Alzheimer's Association Guidelines
* Availability of caregiver/study partner to participate in all study-related visits and who provides ≥8 hours of weekly oversight/care
* Speech frequency pure tone average (0.5- 4 kHz) \>25 db in the better-hearing ear; adult onset hearing loss
* Stable (for 2 weeks or longer) dosing of medication (e.g. antidepressants, antipsychotics) for neuropsychiatric symptoms

Exclusion Criteria:

* Current self-reported use of hearing aid or amplification device
* Medical contraindication to use hearing aids ( e.g. draining ears)
* Inability to participate in the 1-month follow up
Faith-based Approaches to Treating Hypertension and Colon Cancer Prevention

Primary Aim: To evaluate the effect of a lifestyle intervention delivered through telephone-based motivational interviewing (MINT) versus a patient navigation intervention on blood pressure reduction and CRC screening.

Hypotheses: Among black men, aged \> 50 years with uncontrolled HTN and in need of CRC screening:

1. Hyp. 1: those randomized to the lifestyle intervention will have lower BP compared to those randomized to the patient navigation intervention at 6 months.
2. Hyp. 2: those randomized to the patient navigation intervention will have higher CRC screening rates compared to those randomized to the lifestyle intervention at 6 months.

The primary outcomes will be (1) within-patient change in systolic and diastolic BP from baseline to 6 months and (2) CRC screening rates as determined by colonoscopy report or fecal immunochemical test (FIT) result from the primary care provider at 6 months. Blood pressure will be assessed with an automated digital BP monitor based on American Heart Association guidelines.1 CRC screening will be assessed by self-report and verified with medical records and/or the actual colonoscopy or FIT report from participants' providers.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be age 50 years or older
* Participants must have a working telephone (a necessary criterion since much of the interventions are telephone based)
* Self-identified as a black or African American and male
* Have uncontrolled hypertension defined as SBP\>135 mmHg or DBP\>85 mmHg and SBP \>130 mmHg or DBP \>80 mmHg (in those with diabetes) at the screening
* Have a need for CRC screening defined as: 1) no colonoscopy in the last 10 years; 2) no Flexible sigmoidoscopy, Digital Contrast Barium Enema or CT-colonoscopy in the last 5 years, or 3) no Fecal Immunochemical Test or Fecal Occult Blood Test in the last 12 months.
* All participants must be fluent in English. Certain measures used have not been verified in other languages.

Exclusion Criteria:

* Inability to comply with the study protocol (either self-selected or by indicating during screening that he could not complete all requested tasks).
Arginine-stimulated Indication of Early Outcome After Islet Transplantation

Through islet transplantation, functional β-cell mass can be restored. Allogeneic islet transplantation is a treatment modality for a select group of patients with complicated type 1 diabetes mellitus. For patients undergoing (partial) pancreas resection, autologous islet transplantation may help prevent complicated diabetes. Up until now, no studies have been performed on early islet graft function in the first week after transplantation. Early graft function may be a predictor for estimating long-term islet graft success.

Arginine can excite β-cells to release insulin. It can thus provide an estimate of β-cell secretory capacity and can be used as an alternative to (oral) glucose tolerance tests. In this study, we aim to find a predictor model for islet graft function by assessing peak C-peptide after arginine stimulus in the early post-transplantation phase.


Eligibility Criteria:
Inclusion Criteria:

* Age 16 years or older
* Currently on the LUMC waiting list for allogeneic or autologous islet transplantation
* Willing to use a flash glucose monitoring (FGM) system in the two weeks prior to transplantation

Exclusion Criteria:

* Patients who are pregnant
* Patients with known hypersensitivity to arginine
Growth Hormone Treatment in Short Children Born Small for Gestational Age

Comparison of 2 different doses of human growth hormone treatment on change in height after 1 and 2 years of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Born small for gestational age
* actual body height less than or equal -3 SDS
* chronological age greater than 3 years

Exclusion Criteria:

* Growth hormone deficiency
* any defined syndromal disease
* Diabetes mellitus
Exercising Together: An Intervention for Prostate Cancer Survivors and Spouses

The purpose of this study is to explore the benefits of "Exercising Together"-a partnered strength training program for married couples coping with prostate cancer- on the physical and emotional health of prostate cancer survivors and their spouse and on marital quality.


Eligibility Criteria:
Inclusion Criteria For PCS:

* Received treatment for histologically confirmed prostate cancer
* Not currently undergoing radiation therapy or chemotherapy for prostate cancer
* Currently residing with an identifiable spouse willing to participate
* 60 years and older at enrollment

Inclusion Criteria for Spouses:

* Currently residing with prostate cancer survivor

Exclusion Criteria for prostate cancer survivor and Spouses:

* Current participation in moderate/vigorous intensity resistance training 2 or more hours per week
* Cognitive difficulties that preclude answering the survey questions, participating in performance tests, or giving informed consent
* Medical condition, movement or neurological disorder, or medication that contraindicates participation in resistance exercise
* Unwillingness to be randomized
Extracorporeal Shockwave Therapy for the Treatment of Advanced Angina Pectoris

Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones.

The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with refractory angina not amenable to revascularization with angioplasty or bypass surgery.

Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to myocardial ischemic tissue. Shockwaves are created by a special generator and are focused using a shockwave applicator device. The treatment is guided by standard echocardiography equipment. The shockwaves are delivered in synchronization with Patient R-wave to avoid arrhythmias. The treatment is painless.

At first, the patient undergoes stress-SPECT testing to identify the ischemic areas. Following that, the same area is localized by the ultra-sound device and the shockwaves are focused to the ischemic area. Several treatment session (9 in total, spread over 9 weeks) are required for optimal results.

Eligibility Criteria:
Inclusion Criteria:

* Patient is diagnosed with chronic stable angina pectoris, for a period of at least 3 months. Diagnosis is based on medical history, complete physical evaluation.
* Patient has documented myocardial segments with reversible ischemia.
* Patient is classified in AP CCS of III-IV.
* Patient should be on a stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
* Patient demonstrates exercise tolerance capacity of no higher than 125 W on a modified Bruce treadmill exercise test until presence of clinical symptoms (i.e. angina, ST-depression).
* Patient demonstrates exercise tolerance time and stability averaging no more than 25% of each other (the tests will be performed within two weeks and at least a day different between the two).
* Patient has documented epicardial coronary artery disease not amenable to angioplasty or CABG.
* Patient has signed an IRB approved informed consent form.
* Patient's condition should be stable and should have a life expectancy of \>12 months. Patient's current and past medical condition and status will be assessed using previous medical history, physical evaluation, and the physicians (principle investigator's) medical opinion.

Exclusion Criteria:

* Patient is pregnant
* Patient has chronic lung disease including emphysema and pulmonary fibrosis.
* Patient has active endocarditis, myocarditis or pericarditis.
* Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization, or any ESWT machine of a competitor company within 3 months of entry into the study.
* Patients who are unwilling or unable to cooperate with study procedure
A Safety Study of of AG-920 Sterile Topical Ophthalmic Solution

A Phase 3, randomized, placebo-controlled, double-masked, parallel study in healthy subjects. It is designed to evaluate the ocular safety of a single topical ocular administration of AG-920 sterile topical ophthalmic solution compared to placebo..

A Phase 3, randomized, placebo-controlled, double-masked, parallel study in healthy subjects performed in the US. It is designed to evaluate the ocular safety of one dose of AG-920 compared to placebo. I). In this study, subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 2:1 ratio to receive one dose of AG-920 or identical looking placebo into one (study) eye. A subset of subjects will undergo endothelial cell count (ECC) evaluations.

Each dose of AG-920 or placebo will consist of two drops in the study eye. After the completion of dosing, subjects will undergo a series of eye exams that will be documented. Investigational medicinal product (IMP) dosing will be performed by the study staff.

Eligibility Criteria:
Inclusion Criteria:

1. Provide written informed consent prior to any study-related procedures being performed.
2. Male or a non-pregnant, non-lactating female.
3. Healthy by clinical assessment, including ocular examination.
4. Have an Early Treatment of Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) of 20/200 or better in both eyes.
5. Have an Intraocular Pressure (IOP) between 7 and 30 mmHg.

   Specular microscopy subset subjects only:
6. Have a central corneal endothelial cell density of ≥1500 cells/mm2 at baseline

Exclusion Criteria:

1. . Have participated in an investigational study within the past 30 days.
2. Have a contraindication to local anesthetics, Septocaine®, or any component of the IMP.
3. Have had ocular surgery or general surgery in either eye within the past 90 days.
4. Have had an intravitreal injection in either eye within 14 days of randomization.
5. Have ocular surface disease requiring punctal plugs.
6. Have evidence of any current ocular inflammation.
7. Current ocular allergy symptoms.
8. Have used topical, ocular medications in the 24 hours preceding dosing.
9. Systemic opioid, opiate analgesic or topical Non-steroidal Anti-Inflammatory Drug (NSAID) use within the past 30 days.
10. Previous participation in a clinical study of AG-920.
11. A current condition which could cause vision problems such as Pseudotumor Cerebri.
A Study to Investigate the Effect of Itraconazole on the PK of Multiple Doses of Balovaptan in Healthy Volunteers

This study was a non-randomized, open-label, one-sequence, two-period within-subject study to investigate the effect of CYP3A inhibition on the PK of balovaptan in healthy male and female volunteers using itraconazole as a CYP3A inhibitor. The study was conducted at 1 site in the Netherlands.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, urinalysis, and serology.
* Body Mass Index of 18 to 30 kg/m2, inclusive.
* For women of childbearing potential: agreement to use at least 2 acceptable contraceptive methods during the treatment period and for 90 days after the last dose of study drug.
* For men: agreement to use contraceptive measures, and agreement to refrain from donating sperm until 90 days after the last dose of study drug.

Exclusion Criteria:

* Female subjects who are pregnant or lactating.
* Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator.
Care Coordination Educational Intervention Study for Patients from Rural Areas with Early Stage Cancer

Care Coordination is an essential component of cancer care delivery. Many patients experience poor care coordination. In this study, we hypothesize that provision of a video educational intervention to teach patients about cancer, care coordination and self-advocacy will improve patients' perception of care coordination. Cancer patients with early stage disease scheduled to receive adjuvant therapy, and who reside in a rural area, will be enrolled onto the study. Patients will be randomized to receive a table-based educational intervention tool initially (arm1) or after 4 months of therapy (arm2). Assessment of cancer knowledge, self-advocacy and care coordination will be obtained at baseline and after 4-6 months.


Eligibility Criteria:
Inclusion Criteria:

* 18+ years of age
* Breast, lung, or colon cancer diagnosis
* Stage I, II or III cancer
* Adjuvant chemotherapy started \< 30 days or planned within the next 30 days
* Rural residence location in Vermont (outside Chittenden County)
* Proficient in English

Exclusion Criteria:

* History of prior malignancy treated with chemotherapy in last 3 years
* Known or suspected neuro-cognitive impairment
* Resident of Chittenden County, Vermont
* Patients with current diagnosis other than stage I, II or III breast, colon or lung cancer
Assessment of Comfort Level Following an Intravitreal Injection by 30 or 32 Gauge Needles

The purpose of this study is to determine if a smaller needle size reduces discomfort suffered by patients both during and following intravitreal injections. It is the investigators belief that using a smaller size needle will help patients to be less fearful of intravitreal injections and more amenable to treatment. This study will also evaluate the effect of needle size on post injection intraocular pressure, to see if smaller needles may reduce wound leak and increase the intraocular pressure following injection.

The investigators hypothesize that subject eyes injected with the smaller size needle will result in greater patient comfort both during and after their injection as compared to the eye injected with the larger needle. The investigators objective is to reduce any discomfort felt by patients who receive intravitreal injections. The investigators also hypothesize that the smaller needle will result in higher post injection pressures, and another objective is to determine if this can affect patient comfort and increase the risk of glaucomatous optic nerve damage.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study

  * Age \> 18 years
  * Subject's normal therapeutic regimen calls for them to receive two sessions of bilateral injections of the same volume of ranibizumab within the next year.
  * Disease related considerations: None.
  * Other considerations: Subjects who must be able to report pain scores during and up to 48 hours following an intravitreal injection. Also, subjects must consent to at least 5 intraocular pressure checks per eye for each injection procedure.

Exclusion Criteria:

* Pregnancy (positive pregnancy test) or lactation
* Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an intrauterine device, or contraceptive hormone implant or patch.
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* special classes of subjects (vulnerable subjects), such as fetuses, pregnant women, children, institutionalized mentally disabled, or others, especially those whose ability to give voluntary informed consent may be in question.