cyrilzakka/clinical-trials huggingface dataset:
Increasing the Accessibility of a Falls Prevention Intervention for Community Dwelling Older Adults With Low Vision

This study serves to test a previously evaluated falls prevention intervention recommended by the Centers for Disease Control and Prevention, entitled the Study of Accidental Falls in the Elderly (SAFE) Health Behavior and Exercise Intervention, to evaluate if the intervention is accessible to older adults with low vision receiving services from the Southeastern Blind Rehabilitation Center (SBRC). This study also serves to pilot a version of the SAFE intervention that has been adapted to be accessible for individuals with low vision at SBRC.

This study serves to compare the comprehension and retention of individuals completing a version of the SAFE falls prevention intervention adapted for low vision versus individuals receiving the original intervention. One group of participants will complete the standard SAFE intervention format while another group will complete the same intervention with written materials adapted for those with vision loss. One intervention (either standard or adapted SAFE program) will be delivered at a time. The SAFE intervention is comprised of four, 90-minute group classes that address environmental, behavioral, and physical falls risk factors. Classes involve lecture and group discussions as well as review of low intensity exercises. The adapted content is presented in large print with high contrast and has been rewritten on a lower grade level. A nutritionist, a physical therapist, a physician, 5 older adults with low vision, 10 low vision occupational therapist, and 5 health literacy experts provided feedback to strengthen the adapted intervention.

Eligibility Criteria:
Inclusion Criteria:

* 60 and older;
* Visual impairment with some remaining reading ability.

Exclusion Criteria:

* Less than age 60;
* Complete blindness;
* Vertebral osteoporosis.
Endothelial Dysfunction in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)

The purpose of the study is to determine a possible association between the clinical entity of exacerbation, markers of systemic inflammation and endothelial dysfunction in patients with COPD.

Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the lungs; however, there is cumulating data suggesting that the inflammatory reaction associated with COPD is not restricted to the lungs but has systemic effects. Patients with COPD have increased cardiovascular morbidity and mortality. The suspected link between increased cardiovascular mortality and systemic inflammation is endothelial dysfunction, which in turn is caused by impaired activity of NO. Endothelial dysfunction has been demonstrated in patients with COPD. Furthermore there is a close correlation between endothelial dysfunction in coronary and peripheral vessels, which allows assessing flow-mediated dilation (FMD) in the brachial artery via high resolution ultrasound as an early predictor of atherosclerosis. Moreover, systemic inflammatory markers correlate with endothelial dysfunction in patients with stable COPD.

Exacerbations of COPD are episodes of worsening symptoms characterized by increased airway and systemic inflammation. If systemic inflammation is a cause of endothelial dysfunction in COPD, endothelial function would be suspected to be further impaired during exacerbation and recover thereafter. The purpose of this study is to determine a possible association between the clinical entity of exacerbation, markers of systemic inflammation and endothelial dysfunction in patients with COPD.

Eligibility Criteria:
Inclusion Criteria:

* presence of COPD according to standard criteria
* acute exacerbation of COPD according to recommended international criteria
* over 40 years of age
* history of at least 10 py

Exclusion Criteria:

* pneumonia
* history or signs of congestive heart failure,
* acute myocardial infarction
* thoracotomy incl. resection of lungtissue
* interstitial lung disease
* acute or chronic renal failure
* active malignancy
* autoimmune disease
Spinal Cord Stimulation to Treat Hypertension

To investigate the exercise blood pressure response during a lower-extremity dynamic exercise in postmenopausal women with hypertension and to determine if lumbar epidural spinal cord stimulation reduces blood pressure during exercise in postmenopausal women and men with hypertension.

This is a single center study conducted at the University of Minnesota, enrolling up to forty subjects (30 men and 30 post-menopausal women). Subjects will be a assigned to one of the two study arms, (Dynamic Exercise or Spinal Cord Stimulation) and then crossover to the other arm after the initial assignment is complete. However is the screening MRI determines the subject is not a candidate for spinal cord stimulation, then they will be assigned to the Dynamic Exercise arm only.

Eligibility Criteria:
Inclusion Criteria:

1. Men and post-menopausal women between the ages of 40-90 years old
2. Hypertension (defined as BP ≥ 140/90), diagnosed by a physician
3. Ability of the patient to provide consent

Exclusion Criteria:

1. History of cardiopulmonary disorders other than hypertension, as determined on the medical evaluation questionnaire.
2. History of dangerous arrhythmias (arrhythmias requiring treatment or requiring physician supervision)
3. Currently taking specific anti-hypertensive medications that may affect the exercise pressor response or influence the effect of spinal cord stimulation.

   Please contact study staff for information regarding your eligibility.
4. History of spinal fusion or laminectomy at L3 or above
5. Current prescription opioid usage
6. Contraindication to MRI
7. At physician discretion which will be documented on the case report form.
Evaluation of Bone Level Around Stark Conical Screw Implants With V-Blast Surface

Clinical evaluation of osteointegration of bone level implants (Stark conical screw implants, with V-Blast surface treatment), placed without sufficient primary stability.

26 Implants were placed with a unique operative protocol in 4 private offices. A detailed informed consent was obtained from all patients. Surgical guides were used to achieve the idea implant position and axis.

Osteotomy drills were used in the sequence recommended by the implant manufacturer. Bone type was assessed by CT examinations using the classification proposed by Rebaudi.

All implants were tested by applying a lateral mild load with a probe in order to verify mobility immediately after placement.

Parameter used to assess a low primary stability were:

* insertion torque lower than 10 N / cm
* slight mobility of implant upon application of lateral load of 250 g After surgery, patients were instructed not to chew or to wear their removable dentures in the treated areas.

Follow-up post-operative visits were scheduled at 1 and 4 weeks. At 4-6 months after placement a periapical radiograph was taken, a torque/countertorque test of 30 Ncm was conducted and osteointegrated implants were restored. Patients were recalled, examined, and periapical radiographs were taken for a minimum of 6 months.

Eligibility Criteria:
Inclusion Criteria:

* patient who had received Stark bone level V-Blast implants in 4 private offices in Italy
* patient subscribed a detailed informed consent
* same surgical protocol was applied

Exclusion Criteria:

* patient without Stark implant
Efficacy and Safety of TDF+3TC+EFV in Adults With HIV/HBV Coinfection

This is a Phase 4 single-arm, post-marketing clinical trial evaluating the efficacy and safety of tenofovir disoproxil fumarate, lamivudine and efavirenz in adults with human immunodeficiency virus-1 and hepatitis B virus coinfection.

HIV/HBV co-infections are frequently observed due to shared routes of transmission. TDF and 3TC are nucleotide analogues that can inhibit both HIV and HBV DNA polymerases. There is higher risk to cause drug resistance in treating HBV or HIV infection with 3TC or TDF monotherapy than combination trerapy. Combination tharapy could decreases drug resistance. China's HIV epidemic remains one of low prevalence overall, but with pockets of high infection among specific sub-populations and in some localities. China has a very high endemicity for hepatitis B too. A substantial proportion of HIV-infected individuals are co-infected with HBV. TDF + 3TC + EFV will be a common regimen for HIV/HBV co-infected Chinese individuals.

The purpose of this study of this study is to determine whether TDF will be safe for patients with HIV and HBV co-infection and the combination of TDF+3TC+EFV will suppress HIV and HBV viral load below LDL at week 48 of treatment in patients with HIV and HBV co-infeciton.This study will enroll 100 adult subjects and follow these patients for 48 weekes.There will be one enrollment visit(baseline) and visits at 2,4,8,12,24,36,48 weeks after initiation of the study regimen.

Eligibility Criteria:
Inclusion Criteria:

* Serologically-confirmed HIV and HBV infection
* Willingness to participate in a clinical trial
* No previous or current use of antiretroviral regimen
* Clinical conditions stable
* Blood creatinine less than 3 times the upper limit of normal values. HBV DNA\>1000copies/ml, Tbil\<34umol/L,ALT\<400U/L
* With clinical indications for HAART

Exclusion Criteria:

* Patient refuses to sign the consent to participate
* Unwillingness to adhere to visit schedule or maintain adherence with medications
* Illnesses so serve as to likely require hospitalization
* With other conditions that not suitable to be enrolled will be subject to medical review
Study to Investigate Effect of Sildenafil on Clitoral Engorgement as Measured by Magnetic Resonance Imaging (MRI) in Pre-menopausal Women With Female Sexual Arousal Disorder

The purpose of this study is to investigate the effect of 100 mg sildenafil on clitoral engorgement in pre-menopausal women, as well as examining the safety and toleration of the drug.


Eligibility Criteria:
Inclusion Criteria:

* Pre-menopausal women aged 18-45 with a primary diagnosis of Female Sexual Arousal Disorder for at least 6 months prior to entering the study. The FSAD could have been associated with female orgasmic disorder (FOD) and/or superficial or introital dyspareunia.

Exclusion Criteria:

* Subjects with hypoactive sexual desire disorder.
* Subjects not using an acceptable mean of contraception for the duration of the study.
* Subjects who were prescribed and/or taking medication which were contraindicated or cautioned with concomitant intake of sildenafil.
Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation

Prospective double blind randomized controlled trial. By randomizing patients undergoing kidney transplantation into a conventional catecholamine drug (dobutamine) blood pressure maintenance group and a terlipressin-complexed dobutamine group, the investigators compared the effect of intraoperative blood pressure maintenance and the dosage of the vasoactive drug, postoperative graft function, delayed graft function, and other related complications between the two groups, in order to demonstrate whether the use of terlipressin for blood pressure regulation during kidney transplantation is superior to the existing treatments.


Eligibility Criteria:
Inclusion Criteria:

* Patients with end-stage renal disease aged 18 years or above

Exclusion Criteria:

* simultaneous multiple organ transplantation
* known allergy to study medication
* known pregnancy status
* cancellation of surgery due to grafts or personal reasons
* persistent severe preoperative hypertension that may not require intraoperative supportive therapy with vasoactive medications
* any other reason that the supervising physician or the anesthesiologist on duty think the patient is not suitable for the study
Single or Triple Uterine Tourniquet at Myomectomy

The aim of study is to compare triple tourniquet vs. single tourniquet to reduce blood loss at open myomectomy.


Eligibility Criteria:
Inclusion Criteria:

1. Three or more uterine myoma
2. At least one myoma ≥ 8 cm, if there is less than three myoma

Exclusion Criteria:

1. Pedunculated myoma,
2. broad ligament myoma
The Effect of Sulfasalazine on CRH Levels in Pregnant Women

The goal of this randomized clinical trial is to assess sulfasalazine as a potential treatment to prevent recurrent preterm birth. The main questions it aims to answer are:

* Does sulfasalazine down regulate corticotropin releasing hormone (CRH) levels in pregnant persons with a prior history of preterm birth?
* Does sulfasalazine reduce the incidence of recurrent preterm birth in pregnant persons given drug vs. controls?

Consenting participants will be randomized to receive sulfasalazine or to a control group and will undergo serial blood draws to assess plasma CRH levels.

This is a study to assess the potential for sulfasalazine to prevent recurrent preterm birth. The investigators' main objective is to assess the effects of sulfasalazine on the maternal serum biomarker CRH, which is associated with preterm birth.

The will be a pilot randomized controlled trial of pregnant multiparous patients who have had a prior preterm delivery. Pregnant women with a prior preterm birth are at high risk (about 20-30%) of having a recurrent preterm birth. The goal of the study will be to evaluate the effect of sulfasalazine on the maternal serum biomarker CRH at 28, 32, and 36 weeks gestation after randomization of patients to the study drug.

Secondary objectives include evaluating the effect of sulfasalazine on the outcome of delivery less than 37 weeks gestation in this group of high risk pregnant women. Additional composite neonatal outcomes will be assessed.

The proposed study has the potential to identify a novel, low-cost, orally available treatment for preterm delivery based on in vitro evidence and epidemiologic studies suggesting that sulfasalazine may be an effective intervention to prevent preterm birth. If the hypothesis put forth by the investigators is confirmed, sulfasalazine would be an attractive therapeutic intervention that could be implemented for the prevention of preterm birth in both developed and developing nations.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* Singleton pregnancy
* Participants with a history of prior preterm birth in a previous pregnancy
* Participants must be between 12 and 22 weeks gestation.
* Participants must have their pregnancy dates confirmed by ultrasound.

Exclusion Criteria:

* Participants \< 18 years old
* Participants with a cervical length \< 25 mm
* Participants with a multiple gestation
* Cerclage
* Progesterone administration
* Unwilling or unable to swallow the study agent capsule or consume an inert ingredient in the study agent capsule
* Acute liver disease or known liver abnormalities
* Other significant chronic medical or psychiatric illness that, in the investigator's opinion, would prevent participation in the study
* Known hypersensitivity to sulfasalazine
* Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
* History of severe asthma
* Digoxin use
* Porphyria
* Intestinal obstruction
* Urinary tract obstruction
* Hepatic dysfunction
* Renal dysfunction
* Blood dyscrasia such as agranulocytosis, aplastic anemia.
Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema

The aim of this study is to evaluate the feasibility of shear-wave elastography for the diagnosis and staging of breast cancer related lymphedema by assessing the skin and subcutaneous tissues of the arm and forearm, which could serve as a reference standard and be more easily applicable in daily life; and to investigate the relationship between the patients' symptoms and elastographic measurements.

Both upper extremities of 72 patients with lymphedema and 72 healthy upper extremities were included in the study. The patients' demographic and clinical data were recorded. The thickness and echogenicity of the skin and subcutaneous tissues of all extremities were evaluated with B-mode ultrasonography, and the stiffness of the skin and subcutaneous tissues was evaluated with shear-wave elastography. The lymphedema arm and the healthy arm of the patients were compared both with each other and with the data of the control group. Interobserver and intraobserver reliability analysis was performed for ultrasonography and elastography measurements. The patients' pain, tension, weight, and stiffness symptoms associated with lymphedema were questioned using a numerical scale. The patients' functionality and participation in daily life activities were evaluated with the Quick DASH and Life Impact Index questionnaires. The relationship between these findings and elastographic and ultrasonographic parameters was analyzed.

Eligibility Criteria:
Inclusion Criteria:

For the patient group

* between the ages of 18-75
* diagnosed with breast cancer-associated lymphedema by lymphoscintigraphy
* being stage 0-1-2 lymphedema according to ISL staging For the control group
* between the ages of 18-75
* no history of breast cancer

Exclusion Criteria:

* History of surgery in the assessment area
* History of trauma at the assessment site
* Active infection in the assessment area
* Presence of congenital or acquired malformations at the assessment site
* Primary lymphedema
* those with any medical condition that may cause edema, such as advanced heart or kidney failure
Plasma Amino Acid Response to Whey Protein Ingestion Following 28-days of Probiotic Supplementation

Active males and females consumed a probiotic for 28-days. Before and after the intervention period, participants reported to the lab in a fasted state where they consumed 25 grams of whey protein. Following drink consumption, participants provided blood draws at 15-minute intervals. Blood samples were analyzed for amino acid concentrations.


Eligibility Criteria:
Inclusion Criteria:

* 18-34 years old Participants must have at least 1 year of resistance training experience.
* Free of any physical limitations, medications, and supplements that may affect performance, as determined by a health and activity questionnaire.
* Are free of musculoskeletal injuries
* Are not taking medications that may interfere with study measurements

Exclusion Criteria:

* Taking any other nutritional supplement or performance enhancing drug.
* Any chronic illness that causes continuous medical care
* Taking any other nutritional supplement or performance enhancing drug.
* Any chronic illness that causes continuous medical care.
Comparison Between the Lingually Based and the Buccally Based Triangular Flap Design in the Surgical Removal of Impacted Mandibular Third Molars

The primary objective of this study was to compare between the lingually based triangular flap with the buccally based triangular flap in the surgical removal of impacted mandibular third molars.

Many flap designs used for impacted third molar surgery do not place the mucoperosteal incision on sound bone, as they involve incisions that are placed on the extraction socket resulting in higher incidence of mucosal dehiscence, followed by secondary wound healing

This study involved 20 patient with bilaterally mesially angulated impacted third molar (class II position B). One side was surgically removed using the lingually based triangular flap and the other side was surgically removed using the bucally based triangular flap

Eligibility Criteria:
Inclusion Criteria:

Presence of impacted third molar that is misally angulated and retained in bone (class II position B).

Exclusion Criteria:

* Patients with a history of systemic disease (diabetes, renal failure, immunocompromised patients, cardiac patients and patients taking radiotherapy or chemotherapy )
* Compromised dental and periodontal status
* Heavy Smoking.
* Pregnancy or lactation
Evaluation of a Sensory-tonic Stimulation on Development of Parent-infant Interactions and Social Cognition in Very Premature Children

Attachment is built primarily on the first interactions of the first 9 months of a baby's life. These first interactions and their effects of stress, pleasure and displeasure are retained to establish some of the baby's attachment behaviours and future relationships with others.

Extreme prematurity strongly modify these first interactions between parents and child. Very preterm child is separated from his parents and is placed in a stressful, technical and potentially painful environment.

Early interventions stimulate neuroplasticity and can positively affect the neurological development of very preterm infant. Tactile stimuli such as skin-to-skin contact and massages carried out by parents can be pleasant experiences that can support early interactions between parents and child.

The aim of the study is to evaluate impact of a sensory-tonic stimulation on development of parent-infant interaction and on social cognition in very premature children.

Eligibility Criteria:
inclusion criteria :

* very preterm child (born before 32 weeks of amenorrhoea)
* parents agreeing to participate to the study

exclusion criteria :

* child born before 25 weeks of amenorrhoea
* child with a birth weight less than 600 grams
* child with congenital malformation
* child with hemodynamic instability