cyrilzakka/clinical-trials huggingface dataset:
Dissemination of Injury Interventions

An important challenge for the field of injury prevention and control is the translation of research findings into effective community-based prevention programs and practices. The National Center for Injury Prevention and Control believes that dissemination research can overcome this challenge by providing insight into the structures and methods needed to translate injury control research into everyday practice. The proposed dissemination research study will rigorously assess whether the use of a "facilitative system" can successfully bridge the gap between injury prevention and control research and the implementation of evidence-driven, community-based programs, policies, and practices. The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation. The study will use a randomized community trial design to evaluate fall injury occurrence and process measures of program implementation in three groups of communities:

* a control group receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
* a "Standard Program" group receiving modest funding to implement an "evidence-based" fall prevention program in their local community;
* a "Facilitative System" group receiving facilitative system support in addition to the resources provided the Standard Program group.

We hypothesize that the Facilitative System program will be more effective at:

* reducing fall-related injuries in the elderly;
* building community coalitions that are goal-oriented and sustainable;
* implementing community-based, evidence-driven fall prevention programs that are both tailored to the community needs and yet faithful to empirically-tested fall prevention research studies


Eligibility Criteria:
Inclusion Criteria:

* Communities interested in participating

Exclusion Criteria:

* Existing facilitative system in community
Safety, Efficacy, and Pharmacokinetics of Amphotericin B Lipid Complex

The purpose of this study is to determine if initial therapy with ABLC at 10/mg/kg/d for 7 days are at least effective as ABLC at 5.0 mg/kg/d X 14 days as induction treatment of patients with disseminated cryptococcosis and HIV.

This is a randomized, open label, prospective study of ABLC at 5.0 and 10.0 mg/kg/d for treatment of patients with cryptococcal meningitis. Patients will be randomly assigned in a 1:1 ratio to receive 5.0 or 10.0 mg/kg/d of ABLC as induction therapy for cryptococcal meningitis. Patients receiving 10 mg/kg/d doses will be treated with ABLC for 7 days whereas patients receiving ABLC at 5.0 mg/kg/d will receive 14 days of ABLC therapy. After completion of induction therapy subjects will receive long-term fluconazole maintenance therapy at the discretion of the treating physician. The study will be conducted at the Washington Hospital Center

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of cryptococcal meningitis based on any of the following:

   * Cerebrospinal fluid positive for C. neoformans
   * Cerebrospinal fluid positive for cryptococcal antigen
2. Male or female 18 years of age or older.
3. All female patients must be non-lactating and have a negative serum pregnancy test at time of screening. Females of childbearing potential must be using a medically acceptable method of contraception and agree to continue its use during the study period, or must be one year postmenopausal, or have been surgically sterilized.
4. Willing and able to give a signed informed consent, or have a legally authorized representative who is willing or able to give consent

Exclusion Criteria:

1. A history or evidence of hypersensitivity to AmB or any of its metabolites.
2. A history or evidence of any psychiatric, neurological metabolic, or other chronic condition, which in the investigator's opinion, would make the patient unsuitable for the study or interfere with the evaluation of ABLC.
3. Inability to comply with the procedures of the study.
4. Patients who have received greater than 72 hours of therapy with another systemic antifungal agent within 2 weeks prior to enrollment
5. Patients with any of the following abnormal laboratory values

   * Baseline creatinine clearance of less than 50.
   * Bilirubin of greater than 5 times the upper limit of normal
   * AST or ALT of greater than 10 times the upper limit of normal
6. Life expectancy of less than 72 hours
Association Between Ultrasound Morphology of Intestinal Endometriosis Nodules and Symptom Severity

Association between the ultrasound appearance of deep bowel endometriosis and the frequency of pain

In order to improve the diagnostic power of the ultrasound method, it is important to evaluate the association between the ultrasound appearance of the nodule of intestinal deep endometriosis and the frequency of pain, thus assessing the prevalence of moderate or severe clinical symptoms, in patients with newly diagnosed intestinal deep endometriosis, according to the ultrasound morphology of the posterior deep endometriosis nodule proposed in the International Deep Endometriosis Analysis Group (IDEA) Consesus.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years;
* Presence of posterior rectus intestinal deep endometriosis confirmed on TV ultrasound between 01/01/2018 and 30/06/2023;
* Informed consent obtained

Exclusion Criteria:

* Virgo patients;
* Patients reporting intolerance to transvaginal ultrasound;
* Current or history of gynaecological oncology;
* Previous surgery of the sigma and rectum
Endoscopic Transfer of Flexor Hallucis Longus Tendon for Chronic Achilles Tendon Rupture

The transfer of Flexor Hallucis Longus (FHL) in the management of chronic Achilles tendon ruptures has demonstrated good functional outcome, but an extensive surgical field at a vulnerable location may lead to increased risk for soft tissue problems. The arthroscopic FHL transfer may reduce the risk for soft tissue problems. Functional outcome parameters are investigated, wound/soft tissue complications registered.

The transfer of FHL in the management of chronic Achilles tendon ruptures has demonstrated good functional outcome with American Orthopaedic Foot ane Ankle Society (AOFAS) hindfoot scores at 80-89. The extensive surgical field by either a two-incision approach or a single longitudinal posterior approach to the Achilles tendon may lead to an increased risk for soft tissue problems, both infections and wound healing problems. The endoscopic FHL transfer may reduce the risk for soft tissue problems while retaining a good functional outcome. Several functional outcome measures and scores are evaluated a year after surgery.

Prospective study for evaluation of the surgical procedure.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Achilles Tendon Rupture

Exclusion Criteria:

* Pregnancy
* BMI\<18.5 or \>39.9
* Insufficient Norwegian Language proficiency lack of communication skills local skin conditions at site for planned surgery
Comparison of the Cognitive and Behavioral Effects of Eslicarbazepine Acetate and Carbamazepine in Healthy Adults

Double-blind, randomized, two period crossover comparison of the cognitive and behavioral effects of Eslicarbazepine acetate and Carbamazepine in healthy volunteers.

This study is a double-blind, randomized, two period crossover design. The study consists of 6 visits over a 21 week period. Forty six (46) normal healthy subjects will be treated with both Eslicarbazepine acetate (ESL, 800 mg/day) and Carbamazepine (CBZ, 800mg/day) for 6 weeks and 3 days each (maintenance 4 weeks and taper 3 days). Each antiepileptic drug (AED) treatment period will be followed by a four day taper and washout period off AED for the remainder of the month. Cognitive and behavioral testing along with safety testing will be conducted at pretreatment baseline, the end of each randomization AED maintenance period, and after the final washout period.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults between the ages of 18 and 55 years old.
2. Male or female

Exclusion Criteria:

1. Presence of clinically significant cardiovascular, endocrine, hematopoietic, hepatic, neurologic, psychiatric, or renal disease or pregnancy.
2. Presence or history of drug or alcohol abuse.
3. The use of concomitant medications, which are known to affect ESL or Carbamazepine or the use of any concomitant medications that may alter cognitive function (see Section VII.E for a partial list).
4. Use of oral contraceptive hormones or other medications that could be affected by ESL or Carbamazepine.
5. Prior adverse reaction to or prior hypersensitivity to either study medication or to related compounds.
6. Prior participation in studies involving anticonvulsant medications.
7. Subjects who have received any investigational drug within the previous thirty days.
8. Subjects with IQ \< 70 as determined by the Peabody Picture Vocabulary Test.
9. Presence of HLA B\*1502 in subjects of Asian descent; this will be obtained at screening in subjects of Asian descent.
A Dose-Titration Study of GK Activator (2) in Patients With Type 2 Diabetes.

This study will assess the efficacy, safety and tolerability of increasing doses of GK Activator (2) in patients with type 2 diabetes whose condition has not been optimally controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their previous antidiabetic therapy, patients will receive GK Activator (2) orally, twice a day for 12 weeks, at increasing doses of 25mg bid to 200mg bid; doses will be titrated to achieve a target fasting glucose level (FPG) of \<100mg/dL. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years of age;
* type 2 diabetes mellitus treated with one oral antihyperglycemic agent for \>=3 months prior to screening.

Exclusion Criteria:

* type 1 diabetes mellitus;
* treatment with insulin, PPAR agonists or systemic corticosteroids during the 3 months prior to screening;
* women who are pregnant, breast-feeding or not using adequate contraceptive methods.
Percutaneous Nephrolithotomy in Patients With Stage 2-4 Chronic Kidney Disease

The study aims to evaluate the effect of percutaneous nephrolithotomy (PCNL) on estimated glomerular filtration rate (eGFR) in patients with stage 2-4 chronic kidney disease

Nephrolithiasis affects an estimated 5-10% of the general population, and this percentage continues to rise. It has a prevalence of 1.7% to 18% in patients with chronic kidney disease (CKD), and nephrolithiasis-related CKD contributed to 3.2% of the total patients who started maintenance dialysis therapy.

The etiology of renal insufficiency in patients with nephrolithiasis is multifactorial and includes renal obstruction, recurrent urinary tract infections, frequent surgical interventions and coexisting medical disease.

According to National kidney foundation, chronic kidney disease is classified into 5 stages as follows:

Stage 1: Kidney damage with normal or elevated GFR \< 90 ml/min/1.7 m2 Stage 2: Kidney damage with mildly decreased GFR 60-89 ml/min/1.7 m2 Stage 3: Moderately decreased GFR 30-59 ml/min/1.7 m2 Stage 4: Severely decreased GFR 15-29 ml/min/1.7 m2 Stage 5: Kidney Failure GFR\>15 ml/min/1.7 m2 Management of nephrolithiasis in patients with CKD is often difficult. Options for preserving kidney function include watchful waiting, shockwave lithotripsy (SWL), an endourologic approach (Percutaneous nephrolithotomy or retrograde intra-renal surgery), laparoscopic surgery or conventional open surgery.

Percutaneous nephrolithotomy (PCNL) is considered as the gold standard intervention for large burden and complex renal stone disease and is associated with the highest stone free rates (SFRs). However, potentially significant complications include bleeding, sepsis, pleural and visceral injury. Therefore, the optimal management plan needs to be tailored to individual patient.

Serum creatinine level has been used as a crude index of renal function in studies of patients with CKD, but it is not reliable. The glomerular filtration rate (GFR) should be used instead. GFR is the most accurate way to give health providers an estimate of functioning renal mass. Estimating GFR with the use of prediction equations is cost effective.

In this study, we will prospectively evaluate the effect of percutaneous nephrolithotomy on the estimated glomerular filtration rate in Patients With Stage 2-4 chronic kidney disease.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with age group ≥ 18 years old with renal stones candidate for PCNL with pre-operative estimated GFR less than 90 ml/min/1.7 m2 and ≥ 15 ml/min/1.7 m2

Exclusion Criteria:

* Patients with chronic renal failure on regular dialysis.
* Patients with bleeding diathesis.
* Patients who are unfit for surgery.
* Pregnancy
* Patients who are refusing the participation in our study.
Determining Optimal Post-Stroke Exercise (DOSE)

The investigators will conduct a proof-of-concept study to provide preliminary evidence of efficacy of physical exercise dose on ambulatory function in adults undergoing sub-acute stroke rehabilitation.

Participants admitted for stroke rehabilitation will be randomly assigned to either the Stroke Management Group, Stroke Monitoring Group or Stroke Supplementary Group. All three groups will receive usual care, in addition to the intervention. The Stroke Management Group will be provided with periodic information about their progress in the area of mobility using specialized activity monitors. The Stroke Monitoring Group will be progressed according to customized protocols using feedback from specialized activity monitors. The Stroke Supplementary Group will receive the same as the Stroke Monitoring Group, but will also receive one additional hour of daily (5 times per week) physical exercise

Eligibility Criteria:
Inclusion Criteria:

* Have been admitted to a hospital unit for stroke rehabilitation
* Within 10 weeks post-stroke
* 19 years or older
* Are experiencing difficulty walking

Exclusion Criteria:

* Requires greater than one person assist for transfer or ambulation
* Have uncontrolled medical condition or another serious medication condition in addition to stroke
* Unable to understand or follow directions
Efficacy of Low-Level Light Therapy in Reducing Dry Eye in Patients Undergoing Cataract Surgery

The goal of this clinical trial is to evaluate the effectiveness of Low Level Light Therapy (LLLT) in reducing the incidence or alleviating the severity of DED due to meibomian gland dysfunction in otherwise healthy patients undergoing cataract surgery.

Participants will be randomly assigned in a 1:1 ratio to either a treatment group or a control group.

The treatment group will receive LLLT one week before and one week after cataract surgery; the control group will not recieve LLLT at any time.

Researchers will compare the treatment and the control group to see if patients receiving LLLT present with reduced signs and symptoms of ocular surface dysfunction with respect to the control group.


Eligibility Criteria:
Inclusion Criteria:

* healthy patients affected by senile cataract
* patients scheduled for phacoemulsification and intraocular lens implantation

Exclusion Criteria:

* any other ocular comorbidity (e.g. glaucoma),
* chronic instillation of eye drops of any type
* previous ocular surgery or trauma to the addressed eye
* previous cataract surgery in the controlateral eye,
* active ocular infections
* use of systemic drug with a known or suspected link to dry eye (e.g. diuretics, antidepressants, antihistamines, hormone replacement therapy)
* autoimmune diseases (e.g. Sjögren syndrome)
* intraoperative complications (e.g. capsular bag rupture requiring vitrectomy, suprachoroidal hemorrhage)
* postoperative complications (e.g. endophthalmitis, vitritis)
Stabilometry After Pressure Release of the Flexor Digitorum Brevis Muscle Versus a Non-emission Laser: Clinical Trial

Thirty-six subjects randomly distributed between a pressure release intervention group and a control group whose intervention is a non-emission laser. All the subjects will be measured before and after the interventions of each group. The measurements will be made on a pressure platform to record the stabilometry variables.

Thirty-six subjects randomly distributed between a pressure release intervention group and a control group whose intervention is a non-emission laser. All the subjects will be measured before and after the interventions of each group. The measurements will be made on a pressure platform to record the stabilometry variables with eyes closed and open.

Eligibility Criteria:
Inclusion Criteria:

* Must have latent trigger point in Flexor Brevis Digitorum muscles with no other pathologies

Exclusion Criteria:

* Previous lower extremities surgery. History of lower extremities injury with residual symptoms (pain, "giving-away" sensations) within the last year.

Leg-length discrepancy more than 1 cm Balance deficits (determined by oral questionnaire regarding falls)
Risk of Oxygen During Cardiac Surgery Trial

The investigators will recruit and randomize 200 elective cardiac surgery patients to receive physiologic oxygenation (normoxia) or hyper-oxygenation (hyperoxia) during surgery to test the hypothesis that intraoperative physiologic oxygenation decreases the generation of reactive oxygen species, oxidative damage, and postoperative organ injury compared to hyper-oxygenation.


Eligibility Criteria:
Inclusion Criteria:

* Open-heart cardiac surgery, defined as surgery on the heart or aorta that requires sternotomy or thoracotomy.

Exclusion Criteria:

* Current acute coronary syndrome (defined as ST elevation myocardial infarction or non-ST elevation myocardial infarction (troponin leak within 72 hours of surgery or consent +/- EKG changes consistent with myocardial ischemia)).
* Home supplemental oxygen use.
* Preoperative supplemental oxygen requirement to maintain arterial O2 sat of 92%.
* Right to left intracardiac shunt including atrial septal defect and ventricular septal defect with Cor Pulmonale.
* Carotid stenosis defined as \>50% stenosis.
* Cardiac surgery that requires intraoperative circulatory arrest, such as aortic arch replacement.
* Current use of hemo- or peritoneal dialysis.
* Pregnancy
Expanded Access to Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrent Prostate Cancer

This is an expanded access program using 68Ga PSMA-HBED-CC (68Ga-PSMA-11).

The primary goal of this expanded access program is to make 68Ga PSMA-11 PET/CT imaging available to patients.

Imaging and staging of prostate cancer is critical for surgical and treatment planning. Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) has recently been approved by the FDA for clinical use in a formulation utilized at the University of California in Los Angeles UCLA) and San Francisco (UCSF).

The production process for 68Ga-PSMA-11 at the University of Michigan (UM) is different and not FDA approved. This expanded access program was established to allow a continued use of 68Ga-PSMA-11 produced at the University of Michigan for clinical management for prostate cancer at the University of Michigan.

Eligibility Criteria:
Inclusion Criteria:

* Histopathological proven prostate adenocarcinoma
* Elevated PSA after initial therapy: Post radical prostatectomy (RP) - AUA recommendation. PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and confirmatory persistent PSA greater than 0.2 ng/mL
* Elevated PSA after initial therapy: Post radiation therapy or post focal therapy of prostate gland. Nadir + greater than or equal to 2 ng/mL rise in PSA
* Ability to understand a written informed consent document and the willingness to sign it

Exclusion Criteria:

* Current investigational therapy for prostate cancer
* Unable to lie flat, still, or tolerate a PET/CT scan
Evaluation of Implant Fixation in Reverse Total Shoulder Arthroplasty

Reverse total shoulder replacement surgery (RTSA) is performed for individuals with advanced arthritis of the shoulder who also have tears in their rotator cuff muscles. A metal hemisphere is placed in the shoulder blade, and a plastic cup on a stem is placed in the upper arm. This orientation is opposite to the normal anatomy, giving rise to the term "reverse" shoulder replacement. While RTSA has a good clinical track record, no studies have examined how well fixed the implanted components are within patients.


Eligibility Criteria:
Inclusion Criteria:

* will be any patient with cuff tear arthropathy requiring reverse shoulder arthroplasty.

Exclusion Criteria:

* will be any patient with a previous RTSA or TSA (i.e. no revision surgery) or anyone unable to return for RSA imaging (e.g. living \>100 km outside of London).
Study A - MK0767 Monotherapy Study

The purpose of this study is to test if MK0767 lowers blood glucose after 20 weeks compared to placebo.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 Diabetes
* Non-pregnant females and patients who agree not to become pregnant during the study

Exclusion Criteria:

* Patients with Type 1 Diabetes
* Patients who have been treated with insulin or other antihyperglycemic agents
* Patients with viral hepatitis, active liver or gallbladder disease, history of pancreatitis, heart disease, congestive heart failure, inadequately controlled hypertension, HIV positive, history hematologic disorders or neoplastic disease