cyrilzakka/clinical-trials huggingface dataset:
Norwegian Adenomyosis Study III: Peristalsis

Spontaneous contractions (peristalsis) of the non-pregnant uterus is widely investigated and the role of correct peristalsis is most important for correct sperm transport towards the fallopian tubes and implantation of the embryo, thus obtaining pregnancy. At the same time, an impaired uterine peristalsis is discussed to be the reason for lower pregnancy rates and may also account for heavy menstrual bleedings and menstrual pain.

In this study, the uterine peristalsis of women with adenomyosis will be investigated. This condition is associated to heavy menstrual bleeding, menstrual pain and infertility.

The peristalsis of the non-pregnant uterus is widely investigated and the role of correct peristalsis seems to be most important for correct sperm transport towards the fallopian tubes and implantation of the embryo. At the same time, an impaired uterine peristalsis is discussed to be the reason for lower pregnancy rates and may account for dysmenorrhea and menorrhagia. The connection of impaired peristalsis and various clinical symptoms has been shown for patients with e.g. leiomyoma and endometriosis, but not for women with adenomyosis, though the concept seems to be widely accepted.

It has also been repeatedly postulated that impaired peristalsis interferes with implantation of the embryo, yet Martinez-Conejero published a trial that showed a higher incidence of miscarriage, but no effect on embryo implantation in women undergoing oocyte donation. This might either indicate that the postulated effect of peristalsis is wrong or, more likely, since this is a study in an IVF setting, that hormonal treatment with gonadotropin-releasing hormone (GnRH)-agonist could improve implantation.

It is possible to monitor peristalsis with transvaginal ultrasound and standard patterns of uterine peristalsis are defined by Jiland already in 1996.

Findings resulting from the investigations in this study may help to determine the role and extent of impaired peristalsis in women with adenomyosis and possibly give new clues on potential treatments, as well as fill a gap in today's knowledge.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women aged 20-45 years having been diagnosed with adenomyosis earlier and have no other pathology of the uterus, regardless of clinical symptoms.

Exclusion Criteria:

* Postmenopausal women,
* Pregnant women,
* Gynaecological cancer,
* GnRH analog therapy or systemic hormone therapy in the last three months prior to hysterectomy,
* Endometriosis,
* Uterine fibroids
An In-Shoe Device to Monitor Toe-Walking in Children With Cerebral Palsy

The present project will focus on evaluating the technical efficacy of the in-shoe gait monitoring device (ActiveGait) through laboratory based biomechanical gait assessments of children who exhibit gait deviations due to CP or idiopathic toe walking wearing the device.

The investigators on this protocol intend to develop the device and rely on it to propose a Toe Walk Severity (TWS) index, a novel outcome measure for quantifying changes in severity of toe walking over time and for assessing the outcome of surgical and non-surgical interventions.

Tasks include:

A.Validate data acquisition measurements in laboratory setting compared to gold-standard video analysis and field (outside of laboratory).

B.Develop multi-stage classification algorithm from subset of laboratory and field data.

C.Validate classification algorithm against random subsets of laboratory and field data.

D.Explore the development of a Toe Walking Severity (TWS) index from available biomechanical and ActiveGait data for different ambulatory conditions.

E.Perform longitudinal study of the childhood toe walking population including both laboratory analysis and at-home monitoring using ActiveGait technology.

F.Analyze statistically the sensitivity and specificity of the TWS index compared to clinical observations. Gather evidence that the TWS index provides a means to track changes in severity of toe walking over time.

Eligibility Criteria:
Inclusion Criteria:

* able to ambulate 50 feet on level ground without the assistance of a person
* able to ambulate on ramps and stairs without the assistance of a person
* demonstrate a toe-walking pattern at the time of enrollment
* medically stable
* able to understand directions and follow simple instructions

Exclusion Criteria:

* any cardiopulmonary, orthopedic, and neurological conditions other than CP that would prevent them from performing the motor tasks of interest
Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients

This is an exploratory study. No formal hypothesis will be tested.

The objectives of this study are to follow Lupus Nephritis patients over a period of 12 months to:

* Establish the baseline biomarker characteristics of patients
* Determine the variability of biomarker measures over time
* Correlate biomarkers with disease phenotype


Eligibility Criteria:
Inclusion Criteria:

* Adults between 18 and 80 years of age, inclusive
* Diagnosis of SLE by ACR criteria and biopsy-proven ISN/RPS Class III or IV lupus glomerulonephritis within 2 years
* Persistently active nephritis defined as proteinuria greater than or equal to 1.0 g/day for 3 months or more, AND at least 1 of the following:

  * Hematuria (greater than or equal to 5 RBC/hpf) on 2 or more urinalyses done greater than or equal to 2 weeks apart
  * anti-dsDNA positive or anti-Smith positive, or
  * low C3 or C4 complement level. (d) Stable immunosuppression consisting of mycophenolate mofetil (MMF) 13 g/day with/without corticosteroids up to prednisone equivalent of 15 mg/day, or azathioprine 13 mg/kg/day with/without corticosteroids up to prednisone equivalent of 20 mg/day.
* Stable dose of ACE inhibitor/ARB for 4 weeks prior to study enrollment, unless previously intolerant to or having a contraindication to ACE inhibitors and ARBs
* If using oral corticosteroids, must be on a stable dose equivalent to less than or equal to 15 mg/day of prednisone for at least 4 weeks prior to study enrollment. If currently not using corticosteroids, the subject must not have received oral corticosteroids for at least 4 weeks prior study enrollment.
* Clarification of inclusion criteria for controls: Any patient with an idiopathic glomerular disease who does not have lupus nephritis. This includes patients with minimal change disease, membranous nephropathy, focal segmental glomerulosclerosis, and IgA nephropathy.

Exclusion Criteria:

* B-cell depletion therapy in past 1 yr, or evidence of persistent B cell depletion at the time of screening.
* Received an investigational drug (including vaccines) or used an investigational medical device within 3 months of study enrollment or within 5 half-lives of agent, whichever is longer.
Digital Intervention To Improve Diet Quality

This study will develop a digital intervention ("Healthy Roots") adapted from a previously tested adult digital obesity treatment intervention ("Track").

Healthy Roots will focus on improving the clinical encounter between WIC clinicians and socioeconomically disadvantaged mothers, who are disproportionately impacted by obesity, during the first 6 months postpartum.

Prior to the clinical trial portion of this project, quantitative interviews (Aim 1) were held to explore how digital health tools can be use to improve the dietary patterns of mothers and caregivers during the early postpartum period. 13 individuals who receive WIC benefits from Piedmont Health Services will be asked to participate in a one-time interview with research staff.

Following quantitative interviews, the proposed trial (Aims 2 and 3) will test the feasibility of mothers receiving WIC benefits to participate in a pilot digital behavioral intervention to increase diet quality, which will deliver nutrition guidance for meeting recommendations outlined in the Dietary Guidelines for Americans using interactive self-monitoring and feedback, and tailored skills training. The investigator will also explore acceptability of participating in Healthy Roots among both mothers receiving WIC benefits and WIC clinicians who are delivering counseling. This will help determine the potential for this intervention to be implemented into the existing clinical WIC encounter.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years;
* Has a smartphone with a data plan and an email address;
* willing to receive daily text messages;
* receives WIC benefits from Piedmont Health Services (North Carolina)
* has a child that is 24 months or younger
* speaks English as primary language.

Exclusion Criteria:

* participating in another related clinical trial;
Study of the Blood Concentrations of Two Formulations of REGN2222 in Healthy Subjects

Primary Objective: Determine blood concentrations of two formulations of REGN2222

Secondary Objective: Assess safety and tolerability of REGN2222


Eligibility Criteria:
Key Inclusion Criteria:

1. Healthy man or woman aged 18 to 60 years
2. Body weight between 50.0 kg and 95.0 kg, inclusive
3. Willing and able to comply with clinic visits and study-related procedures
4. Provide signed informed consent

Key Exclusion Criteria:

1. Hemoglobin not within normal limits
2. Positive drug and alcohol screen test results at screening visits 1 and 2
3. Participation in any clinical research study that evaluated another investigational drug or therapy within 30 days or at least 5 half-lives, whichever is longer, of the investigational drug, prior to the screening visit
4. Pregnant or breastfeeding women, and women of childbearing potential
5. Sexually active men who are unwilling to practice adequate contraception during the study
The Influences of Early Mobilization on Myokines, Body Composition and Outcomes in ICU Septic Patients

the investigators' preliminary data revealed that early physical therapy in patients with sepsis in ICU could promote recovery of function (liver and kidney) and decrease the length of stay in hospitalization. The levels of plasma IL-6 and IL-10 were higher in non-survival group than in survival group. the investigators hypothesize that myokines and body composition parameters are related to the prognosis of sepsis.the investigators will investigate the influences of duration and intensity of early mobilization on myokines, body composition and outcomes of septic patients in intensive care. The proposed study can help precision medicine in the future.

The septic patients admitted to the intensive care unit (ICU) will be divided into three groups. One is non-PT group, with no physical treatment intervention (group 1), Early-PT group with physical treatment intervention started in ICU admission day 3 (group 2), and Delayed-PT with physical treatment intervention started after ICU admission day 3 (group 3). The grouping will be based on clinical indication for early mobilization (physical therapy) as below. The body composition data (of day 1, 3, 8) of the patients in the three groups will be measured, and the residual blood from day 1 and day 8 will be collected for detecting myokines.

Eligibility Criteria:
Inclusion Criteria:

* 1. Aadmission in ICU 2. Clinical diagnosis of sepsis

Exclusion Criteria:

* 1. Expired in 3-days 2. Cardiac stents or pacemakers 3. Airborne disease 4. Contact-transmitted disease
SAFE (Sarpogrelate Anplone in Femoro-popliteal Artery Intervention Efficacy) Study

After endovascular treatment (EVT) for peripheral artery disease (PAD), dual antiplatelet therapy (DAAT) of aspirin (ASA) and clopidogrel are currently drug of choice to prevent occlusion. Anplone SR®, controlled-released Sarpogrelate hydrochloride, has been introduced as an anti-platelet agent for the drug of PAD. The aim of this study was to compare the efficacy and safety of Anplone + aspirin and clopidogrel + aspirin in patients who underwent EVT for femoro-popliteal occlusive disease.


Eligibility Criteria:
Inclusion Criteria:

1. Adult, \>18 years old
2. Angiographically-confirmed significant femoro-popliteal (FP) stenosis or occlusion by atherosclerosis
3. Successful FP intervention; residual stenosis \<30%
4. Without significant residual inflow disease; Intact iliac artery inflow (with or without intervention of iliac or below knee arteries)
5. patent outflow status; at least 1 arterial runoff in below knee arteries
6. All kind of fem-pop intervention including POBA, stent, DCB, DES for TASC A\~ D

Exclusion Criteria:

1. At risk of hemorrhage, bleeding tendency or thrombophilia
2. Acute limb ischemia / inflammatory arterial disease
3. Contraindication or allergic to ASA, clopidogrel, Anplone
4. Medication of warfarin
5. Pregnancy, hepatic dysfunction, thrombocytopenia
6. Previous FP bypass or intervention
7. Impossible to stop clopidogrel before EVT
Use of Near Infrared Spectroscopy to Measure Intracranial ScvO2

The purpose of this study is to determine whether analysis of near infrared absorbance signals that occur at different frequencies might provide information about the difference in oxygen saturation between arterial and venous blood.


Eligibility Criteria:
Inclusion Criteria:

* Adult 18-65 years of age

Exclusion Criteria:

* Dilated cardiomyopathy
* Congestive heart failure
* Pulmonary hypertension
* Severe aortic stenosis
* Flail chest
* Chest pain
* Shortness of breath
A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With HBeAg-Negative Chronic Hepatitis B Treated With Nucleos(t)Ide Reverse Transcriptase Inhibitors

This is a multicenter, randomized, controlled Phase IIa study of HH-003 injection, HH-003 injection is a monoclonal antibody targeting Hepatitis B virus. This study aims to evaluate the antiviral activity and safety in subjects with with HBeAg-negative Chronic Hepatitis B treated with nucleos(t)ide reverse transcriptase inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form;
* Male or female aged from 18 to 65years (inclusively);
* 18 kg/m\^2≤BMI≤32 kg/m\^2, body weight≥45 kg for men and ≥40 kg for women;
* At screening, etiological, clinical, or pathological evidence indicates chronic hepatitis B virus infection for at least 6 months; and negative HBeAg for more than 6 months; 10 IU/mL≤HBsAg≤3000 IU/mL; HBV DNA≤20 IU/mL; ALT≤1×ULN;
* Participants who have been on the treatment of nucleos(t)ide reverse transcriptase inhibitors (limited to entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\], or tenofovir alafenamide fumarate \[TAF\]) for at least 3 years (as judged by the investigator) at screening.

Exclusion Criteria:

* Females who are pregnant or lactating at screening;
* History of alcoholic liver disease, non-alcoholic steatohepatitis, autoimmune liver disease, other hereditary liver disease, drug-induced liver disease or other clinically significant chronic liver disease induced by non-HBV infection;
* History or presence of progressive liver fibrosis or cirrhosis, including but not limited to liver stiffness measurement \[LSM\] ≥ 9 kPa at screening, progressive liver fibrosis or cirrhosis (e.g., S ≥ 3 in GS score or METAVIR ≥ F3) by liver histopathology examination, according to the Consensus on the diagnosis and therapy of hepatic fibrosis \[2019\]; or the presence of ascites, hepatic encephalopathy, upper gastrointestinal bleeding, or esophageal and gastric varices.
* History or presence of hepatocellular carcinoma, or alpha-fetoprotein (AFP) ≥ 50 ng/mL at screening; or suspicion of hepatocellular carcinoma indicated by liver ultrasound, CT, or MRI.
* Use of antiviral therapy with interferon within 1 year prior to screening
* Any of the following lab test results at screening: total bilirubin \>2xULN or direct bilirubin \>1.5xULN, hemoglobin \<120 g/L for males or \<110 g/L ro females, platelets count\<100,000/mm\^3 (100×10\^9/L), and absolute neutrophils count \<1,500/mm\^3 (1.5×10\^9/L), Serum albumin \< 35 g/L; international normalized ratio (INR) of prothrombin time \> 1.3; or estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2.
Premedication for Less Invasive Surfactant Administration Study (PRELISA)

The purpose of this study is to conduct a double blinded randomized control trial to determine the safety and efficacy of using IV fentanyl and atropine prior to Less Invasive Surfactant Administration (LISA) procedure in preterm infants with Respiratory Distress Syndrome compared to the local standard of care to perform this procedure without any premedication.

Hypothesis: In infants greater than or equal to 29 weeks gestational age requiring the Less Invasive Surfactant Administration procedure, premedication with a combination of IV atropine and IV fentanyl will be associated with fewer combined bradycardia events, defined as heartrate less than 100 beats per minute for longer than 10 seconds, and hypoxemia events, defined as saturations less than or equal to 80% for longer than 30 seconds, during the procedure compared with placebo.

Specific Aims:

* To determine if infants receiving IV fentanyl and atropine prior to LISA will have a decrease in hypoxemia and bradycardia events during the procedure compared to infants receiving placebo
* To determine if infants receiving premedication prior to Less Invasive Surfactant Administration will have higher procedure first attempt success rate compared with infants receiving placebo
* To determine the effect of premedication on cerebral oxygenation compared to placebo during and for 12 hours after Less Invasive Surfactant Administration using cerebral Near Infrared Spectroscopy
* To determine the effect of premedication prior to Less Invasive Surfactant Administration on the need for mechanical ventilation for 24 hours after the procedure


Eligibility Criteria:
Inclusion Criteria:

* Infants ≥29 weeks gestational age between 0-72 hours of life on CPAP for respiratory support who qualify for the LISA procedure as determined by the primary team using Parkland OPTISURF guidelines

Exclusion Criteria:

* Infants requiring intubation prior to surfactant therapy
* Infants with known severe congenital anomalies (including complex congenital heart disease, airway, and central nervous system anomalies)
* Infants born to mothers with known opioid addiction or in a methadone treatment program
Improving Self-regulation & School Readiness in Preschoolers

This project will develop and evaluate the initial effectiveness of an intervention training executive functioning, metacognition, and self-regulation in preschoolers attending certain high poverty Cincinnati preschools. Studies show that these skills are critical for school performance, and that children with better executive functioning have better long term outcomes. It is also important to intervene early when children are most likely to profit because their brains are rapidly developing. There are some promising programs targeting these skills in preschoolers, but few are available to teachers for implementation in the classroom setting. The specific aims of this study are: 1) to adapt a promising clinic-based program for the preschool classroom environment, and 2) to test the feasibility and initial impact of the adapted program on executive functioning and school readiness in schools with a high proportion of children from low income families.

We propose to translate a promising intervention, Executive-function Training for Attention and Metacognition (ETAM), originally developed for use in a clinic setting, to be delivered in the school setting, ultimately by teachers. Specifically, we propose to develop a curriculum that can be added to the classroom curriculum which will target the development of self-regulation and metacognition in preschoolers. Thus the purpose of the study is to 1) develop a teacher training program based on the principles we have found to be effective in a parent-based intervention and 2) test the feasibility and initial efficacy (i.e., reduced disruptive behaviors and increased school readiness) of the program in children from low income families. We will randomly assign 6 preschools to receive the teacher training component and 6 schools to serve as a control group (i.e., will not receive the intervention). We will conduct assessments on all preschoolers in the classroom prior to delivering the teacher training (i.e., beginning of the school year), provide the training to preschoolers in classrooms randomized to the active intervention group, and then conduct assessments at the end of the school year. Our primary aims are to assess the feasibility of a program designed to train teachers to incorporate the principles of the training program into the daily classroom environment, and to assess whether the program improves executive functioning and functional outcomes \[i.e., Attention/Deficit-Hyperactivity Disorder (ADHD) symptoms, academic readiness, social competence\], as compared to outcomes of children in the control schools. Although study personnel will be responsible for delivery of the intervention, preschool teachers will be closely involved in the process to provide ongoing feedback regarding the study intervention.

Eligibility Criteria:
Inclusion Criteria:

All children in preschool classrooms in selected schools.

Exclusion Criteria:

None
Open Maxillary Sinus Augmentation Using Different Types of Bone Particles

Two stage sinus lifting using Nano hydroxyapatite particles \[Nanostreams\] versus Deprotenized bovine bone \[Tutogen\] : Randomized clinical trial.

comparing between Height of new bone formation, Bone area percent( Histomorphometric)


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* sinus pathology
* heavy smokers
* patients with systemic disease uncontrolled
Phase 3 Study of Levulan With New Blue Light for AK on the Face or Scalp

The purpose of this study is to prove the safety and efficacy of Levulan Kerastick (aminolevulinic acid HCl) for Topical Solution 20% followed by 10 J/cm2 of blue light delivered at 10 mW/cm2 or 20 mW/cm2 in the treatment of multiple actinic keratosis on the face or balding scalp (the Treatment Area), utilizing a 14-18 hour incubation period.


Eligibility Criteria:
Inclusion Criteria:

* Four to fifteen Grade 1/2 actinic keratosis lesions (AKs) on the face OR balding scalp

Exclusion Criteria:

* Pregnancy
* grade 3 and/or atypical \>1cm AKs within Treatment Area and/or more than 15 AKs of any Grade within the Treatment Area
* history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
* lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
* skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
* Subject is immunosuppressed
* unsuccessful outcome from previous ALA-PDT therapy
* currently enrolled in an investigational drug or device study
* has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment
* known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol)
* has active herpes simplex infection in the Treatment Area OR a history of 2 or more outbreaks within past 12 months, in the Treatment Area
* use of the following topical preparations on the extremity to be treated:

  * Keratolytics including urea (greater than 5%), alpha hydroxyacids \[e.g.glycolic acid, lactic acid, etc. greater than 5%\], salicylic acid (greater than 2%) within 2 days of initiation of treatment.
  * Curettage or Cryotherapy within 2 weeks of initiation of treatment
  * Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks of initiation of treatment.
  * Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment.
* use of systemic retinoid therapy within 6 months of initiation of treatment.