cyrilzakka/clinical-trials huggingface dataset:
Social Risks-Focused Lifestyle Intervention to Reduce Preeclampsia (SAIL)

Preeclampsia is a disease of pregnancy and first few weeks after birth. It is diagnosed as new onset of high blood pressure and injury to organs such as kidneys, liver, and brain. Preeclampsia is growing at a rapid rate - rate that exceeds diabetes and heart disease. Over half a million lives lost each year to preeclampsia. Women with a history of preeclampsia have 3-4 times the risk of high blood pressure. They also have double the risk for heart disease and stroke. Racial and ethnic disparities are present in preeclampsia. Black women are at higher risk of developing preeclampsia. They are also at much higher risk of dying from preeclampsia than other women. The reasons behind such disparities are unclear. What may explain these differences are social determinants of health. The contribution of social determinants to differences in preeclampsia is well recognized. However, a major gap in research remains strategies that address these factors. Our study will test a lifestyle intervention incorporating social risk factors to reduce the risk of preeclampsia.

Preeclampsia is a significant global health problem affecting over 10 million pregnancies each year. Preeclampsia disproportionately burdens ethnic minority women, especially African American women when compared to non-Hispanic white women. Once diagnosed with preeclampsia, African women are 3 times more likely to die of preeclampsia compared to their white counterparts. Evidence supports contribution of social risk factors towards racial and ethnic disparities seen with preeclampsia. However, currently, there are few trials that examine efficacy of social risks-focused lifestyle interventions on reduction of preeclampsia and its complications. This proposal is designed to address this crucial gap by testing feasibility (Aim 1), acceptability (Aim 1) and efficacy (Aim 2) of a social risks-focused lifestyle intervention to reduce preeclampsia in pregnant inner-city African American women. The intervention will be delivered via a randomized control trial design (N=100), with 6 monthly group sessions conducted in the second and third trimesters. The overall hypothesis is that the intervention will be feasible and acceptable, and that women randomized to the intervention group will have lower blood pressure and lower rates of preeclampsia compared with women receiving routine prenatal care.

Eligibility Criteria:
Inclusion Criteria:

* self-report as African-American/Non-Hispanic black
* residence in inner-city Milwaukee
* nulliparity
* gestational age at enrollment \<=16 weeks
* able and willing to give informed consent

Exclusion Criteria:

* not able to communicate in English
* major fetal anomaly
* psychiatric illness that precludes group participation
Understanding Non-radiotherapy-based Development of Trismus

A limited mouth opening (or trismus) after surgery for oral cancers is not only one of the most common complications, but it is also a major contributing factor towards an impaired quality of life after surgery. The enormous impact on the quality of life is secondary to impeded speech, feeding, drinking, and aesthetics.

The aim would be to analyse the opening of the mouth before and after surgery, and if applicable after radiotherapy, in a prospective way in oral cancer cases. There is namely a major discrepancy in current science research between the effect of different treatment modalities on trismus, as, in contrast with known research regarding the effect of surgery on trismus, a clear relation between radiotherapy and trismus has already been demonstrated in multiple research articles and systematic reviews. Nevertheless, the clinical experience of this research group supports the need for further investigation on the impact of surgery and the different modalities of surgery on trismus.

The investigators are convinced that revealing the surgical factors, linked with trismus, can lead to better prevention and prediction of later trismus for newly diagnosed oral cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* All patients with a newly diagnosed oral cancer.
* Cases with a limited mouth opening secondary to oral tumour resections

Exclusion Criteria:

* Minors.
* Deceased cases within the follow-up period of one year.
* Other malignancies than oral squamous cell carcinomas.
Quadratus Lumborum Block for Total Hip Arthroplasty

The quadratus lumborum (QL) block is a fascial plane block that has been described to provide analgesia from T7-L3 dermatomes. The investigators aim to evaluate the efficacy of QL blocks in patients undergoing primary total hip arthroplasty (THA).

Investigators will enroll subjects planned for primary THA and allocate them into receiving a QL block with either saline or ropivacaine. Primary outcome will be pain scores over the first 48 hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects undergoing elective primary total hip arthroplasty

Exclusion Criteria:

* patients age \< 18,
* documented allergy to local anesthetic
* presence of peripheral neuropathy
* patients with current long term opioid use defined as receiving an opioid on most days in a 90 day period
* patients with a contraindication to spinal and regional anesthesia such as coagulopathy or infection at the site of the regional technique.
Reducing Hazardous Alcohol Use in Social Networks Using Targeted Intervention: 21 Rising

The primary goal of this study is to determine whether change in alcohol use among college students can be transmitted through social network ties to other members in the network. Members of one college class at a northeastern university will be enrolled in a longitudinal study in which they will provide self-reported behavioral information and information about their social ties to others in their college class. A subset of heavy drinking participants will be asked to meet in person to complete an interview about their alcohol use - called a Brief Motivational Interview. There is evidence that this sort of interview can reduce harmful alcohol use. The investigators expect that following the Brief Motivational Interview others in their friendship clusters will show reduced harm associated with alcohol use as well.


Eligibility Criteria:
Inclusion Criteria:

• Must be a member of the class of 2021 or 2021.5 at the site university

Exclusion Criteria:

• None
National Registry of IgG4-RD in China

The aim of this study is to establish a nation-wide cohort study of IgG4-related disease (IgG4-RD) in China.

Methods: All the patients fulfilling diagnostic criteria of IgG4-RD (2011) would be enrolled from multi-centers around China. A online database system has been established.

Endpoints: The primary endpoint is to investigate the clinical manifestations of Chinese IgG4-RD patients; the secondary endpoints including the demographic features,laboratory characteristics, immunological tests, imaging and pathological features, in addition, the treatment and prognosis of the disease.

This is a multicenter registry study of IgG4-RD patients. Newly diagnosed IgG4-RD patients will be recruited from allover the China. Inclusion criteria: patients with definite, probable, or possible IgG4-RD according to the 2011 comprehensive diagnostic criteria for IgG4-RD will be recruited. Exclusion criteria: patients with malignancy or other autoimmune diseases are excluded.

The data will be uploaded through the platform of Chinese Rheumatology Information Platform. Demographic data, initial symptoms, disease duration, history of allergy, and physical examination, organ involvements, laboratory findings, radiological and pathological results, as well as treatment, side effects will be recorded.

This study was approved by the Medical Ethics Committee of PUMCH (Beijing, China). All patients will signe informed consent.

Statistical Analysis: All parameters are described in the standard summary statistics, including mean, standard deviation, minimum, and maximum. All statistical analyses will be performed by SPSS.

Endpoints: The primary endpoint is to investigate the organ involvements of Chinese IgG4-RD patients. The secondary endpoints including the demographic features,laboratory characteristics, immunological tests, imaging and pathological features, in addition, the treatment and prognosis of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Conforming to the diagnostic criteria of IgG4-RD (2011);

Exclusion Criteria:

* Excluding other mimicing IgG4-RD, including tumors, vasculitis and sarcoidosis.
Impact of Surfactant's Availability on Newborns

To identify what happened to specific groups of newborns after surfactant was introduced to the market. Were the same benefits with regard to morbidity, mortality, and resource use in evidence post treatment investigational new drug (IND)?

BACKGROUND:

The clinical trial literature on surfactant clearly demonstrated that surfactant therapy resulted in improved early respiratory status and improved mortality rates for premature newborns infants suffering from respiratory ailments due to surfactant insufficiency. However, the clinical trial experience regarding efficacy did not ensure that the same benefits would be conferred on patients outside the clinical trial environment during routine medical care.

DESIGN NARRATIVE:

The investigators had already demonstrated in an epidemiological study published in the New England Journal of Medicine (May 1994) that morbidity, mortality, and resource use among very low birth weight inborn infants declined once surfactant became available. This study broadened the focus to include infants excluded from the original study. The hypotheses for the study centered on the investigators' belief that infants who were in the 1500 to 2500 gram weight group also experienced reduced mortality, morbidity, and resource use post-surfactant, as did those who were mature with severe respiratory disease, and those who were outborn i.e. those who were transferred to a perinatal center. Finally, because of the significant focus on health care reform and quality assurance in clinical care the investigators included a hypothesis focusing on the impact of payer on mortality, morbidity, and resource use. The original study identified that the payer was not a factor differentiating the newborns with regard to any measures of outcome or resource use. The investigators hypothesized that this would remain the case. However, they suspected that there might be some indications in their analysis among patients who were outborn that HMO or managed care was influencing not only where births were occurring, but how well fragile newborns did in the clinical environment. All the analyses used analytic datafiles from the National Perinatal Information Center's Perinatal Center Database. A pre-and post-surfactant period was created using eleven perinatal centers who provided data on all newborns from 1985 and 1992. Infants were divided into two groups according to whether they were born before or after surfactant was introduced into clinical practice. Regression models controlling for race, sex, and birthweight were used to assess morbidity, mortality, and resource use.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Peritoneal Bacterial Contamination Following Resection With Closed or Open Rectal Stump for Left-sided Cancer

The purpose of this study is to check if there is a difference in peritoneal contamination in patients undergoing rectal resection with closed and open rectal stump prior to anastomosing.

There is not much information regarding the peritoneal bacterial contamination during colorectal surgery. The null hypothesis is that there is no difference in peritoneal contamination following resection with closed or open rectal stump for left-sided cancer. Patients scheduled for elective resection are allocated for open resection with the distal stump closed or open. Anastomosis is performed while a clamp is placed on the rectal stump in one arm of the study while in the other arm, the stump remains open until the anastomosis is completed. A second bacterial sample will be obtained at the completion of the anastomosis from the same place (pelvic pouch) as the first one. After sampling an air leak test will be performed. A quantitative assessment of the number of Colony Forming Units (CFU/ml) of aerobic and anaerobic bacteria will be done for each patient. Operative time and time interval between samples will be measured. Postoperatively, possible complications (surgical site infections, leakage) will be monitored. The primary objective will be to determine the differences in peritoneal contamination between closed and open rectal stump during colorectal surgery.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive adult patients scheduled for a left colectomy, sigmoidectomy or rectal resection with a proposed anastomosis at the level of the rectum agreeing to participate in the study.

Exclusion Criteria:

* Patients without informed consent
* Class V patients on American Society of Anesthesiologists (ASA) of Physical Health Score
* Patient with prior peritonitis
* Patients with acute inflammatory bowel disease
* Recent antibiotic treatment
Efficacy of App and Electronic Device in the Treatment of Premature Ejaculation

Randomized control trial to determine if we can produce increases in the IELT using a new masturbator electronic in subjects with premature ejaculation in combination with a exercise app, producing improvements in the quality and satisfaction of the sexuality of the patient.

This project of research will use one experimental groups, It will manage the affairs the therapy "sphincter control training" (SCT) into app combined with the external device called Myhixel I .Experimental groups will receive therapy with the protocol of exercises SCT.

The main measure will be the "fold increase" (FI) of the IELT, which was calculated using the geometric mean of post-treatment IELTs (period B) divided by the geometric mean of pre-treatment IELTs (period A): FI = (geometric mean of IELT_7wk)/(geometric mean of PRE_IELT)

The efficiency on the EP will see (IELT) reflected in an increase in the times of latency of intravaginal ejaculation and in punctuations of subjective perception, of the therapy on the line base.

The subjects that will be born in mind will be all the interested parties in informing that their answer to the campaign of national advertising that will be started.

The duration of the treatment will be 8 weeks during which a series of exercises app will be practised usin the masturbation device Myhixel I.

The material used in the research will be innocuous and his responsible use does not produce adverse reactions of interest.

Eligibility Criteria:
Inclusion Criteria:

* Aged over 18 years.
* Being in a heterosexual relationship for at least the last 6 months.
* Having a score of \>11 on the Premature Ejaculation Diagnostic Tool (PEDT).
* Having a self-reported IELT ≤2 minutes.

Exclusion Criteria:

* A history of alcohol abuse or dependence.
* Having received medication or psychological treatment for PE in the last 6 months.
* Having diabetes.
* The regular use of recreational drugs (except tobacco and caffeine).
Cardiac Auscultation Using Smartphones

The investigators performed a proof-of-concept study enrolling subjects with normal and pathologic heart sounds. Heart sound was recorded by auscultation on the skin of the chest wall using three smartphones: Samsung Galaxy S5 and Galaxy S6, and LG G3 . Recorded heart sounds were processed and classified by a diagnostic algorithm using convolutional neural networks.

Heart sound recording was done by researchers who were familiar with the use of the app and understand the principles of cardiac auscultation.

Reference heart sounds were recorded using an electronic stethoscope (3M™ Littmann® Electronic Stethoscope Model 3200). Study devices included Samsung Galaxy S5 (model SM-G900), Galaxy S6 (SM-G920), and LG G3 (LG-F400).

Eligibility Criteria:
Inclusion Criteria:

* subjects who gave informed consent
* subjects who are 18 years old or older and had performed ECG and echocardiography during the previous 6 months.

Exclusion Criteria:

* subjects with impairment of cognition
Evaluating the Effects of Psychological Stress on Salivary Biomarkers in Pediatric Patients Visiting Pediatric and General Dental Clinic

the goal of this study is to test the effect of psychological stress on pediatric patients visiting specialized and general dental clinic by measure salivary cortisol and salivary alpha amylase and by use children fear survey schedule -dental subscale .

80 male subjects will be enrolled in this study between 4-6 years old with first dental visit ,40 subjects visiting specialized pediatric dental clinic to see the effect of specific environment and attitude of dentist on child stress ,and 40 subjects visiting general dental clinic with normal environment and general dentist .

the method of study is by taking two saliva sample from child , first when he will enter the clinic at reception and second after half hour when he will diagnosed without any type of treatment.


Eligibility Criteria:
Inclusion Criteria:

* male
* 4-6 years old
* first dental visit
* patients with no systemic disease

Exclusion Criteria:

* medically compressed patient
* patients with systemic disease
Investigation of the Effect of Acceptance and Commitment Therapy-Based Intervention in Oncology Patients

The goal of this clinical trial is to investigate the effectiveness of Acceptance and Commitment Therapy Based Intervention for Oncology Patients. The main questions it aims to answer are:

* Does the Acceptance and Commitment to Therapy-Based Intervention for Oncology Patients affect the level of psychological distress?
* Does the Acceptance and Commitment to Therapy-Based Intervention for Oncology Patients affect the level of reintegration into normal life?

Researchers will compare Acceptance and Commitment Therapy-Based Intervention for Oncology Patients (ACT) to Psychoeducation for Oncology Patients and routine care (with no specific intervention) to see if Acceptance and Commitment Therapy-Based Intervention for Oncology Patients is effective in psychological distress and reintegration into normal living.

Participants:

* They will be randomly divided into three groups (Group 1: ACT, Group 2: Psychoeducation, Group 3: Routine care).
* All participants will be asked to complete data collection forms.
* Group 1 will participate in a 5-session Acceptance and Commitment Therapy-Based Intervention for Oncology Patients intervention program.
* Group 2 will participate in a 5-session Psychoeducation for Oncology Patients program.
* During this period, participants in group 3 will continue their routine treatment.
* After completion of the interventions, participants will be asked to complete the data collection forms again.
* The researchers will then analyze the results and write the report.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older,
* Being able to read and write,
* Receiving oncologic treatment,
* Being diagnosed with breast cancer,
* To know about Medical Diagnosis,
* Being in stage 1, 2 or 3 of the disease,
* Receiving outpatient chemotherapy treatment only,
* Internet access and computer skills to participate in online group interviews,
* Low to moderate scores on the brief psychological resilience scale,

Exclusion Criteria:

* Having serious psychiatric or cognitive impairments that limit adherence to group sessions,
* Having a physical disability that may make it difficult to participate in group sessions,
* Failure to attend sessions regularly and absenteeism,
* Currently being in a psychoeducation/psychotherapy group
The Specific Elastance in ARDS Patients: a Pediatric Study

Aim of this study is to assess lung specific elastance in a population of pediatric patients with Acute Respiratory Distress Syndrome (ARDS) treated with mechanical ventilation, and in a pediatric population of ICU patients with healthy lung which are treated with mechanical ventilation for other clinical purposes.


Eligibility Criteria:
Inclusion Criteria:

* ARDS (Berlin Definition Criteria) or mechanical ventilation in healthy lungs

Exclusion Criteria:

* Hemodynamic instability
* Lung diseases other than ARDS
* Parental refuse
RAD001 in Advanced Sarcoma

This trial intends to test the efficacy and safety of RAD001 in patients with advanced sarcoma who failed to conventional chemotherapy.

This multicenter, phase II trial evaluated the efficacy and safety of everolimus in patients with metastatic or recurrent bone and soft tissue sarcoma after failure of anthracycline and/or ifosfamide.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed metastatic, unresectable bone or soft tissue sarcomas who had past treatment with anthracycline and/or ifosfamide to which the disease was primarily refractory or progressed after initial response.
* Any of above drugs is allowed to be used as adjuvant treatment.
* Unidimensionally measurable disease
* 3 or less than prior chemotherapies
* Age 17 years old or older
* ECOG performance status 2 or less, Life expectancy 6 month or less
* Adequate bone marrow, liver, kidney, and cardiac function
* Written informed consent

Exclusion Criteria:

* Pregnant or lactating patients
* Patients with resectable metastasis
* Patients with history of CNS metastasis
* Gastrointestinal stromal tumors, chondrosarcoma, neuroblastoma
* Hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients.
* Any preexisting medical condition of sufficient severity to prevent full compliance with the study
Treatment of Challenging Macular Holes Using Plasma Rich in Growth Factors

Aim of the Study:To report the structural and visual outcomes of plasma rich in growth factors in closure of challenging macular holes

Challenging full thickness macular holes ( FTMH) include :

Recurrent FTMH Persistent (refractory) FTMH Macular holes in eyes with pathological myopia Large macular holes with an inner diameter of more than 650 µm. Plasma rich in growth factors (PRGF) is characterized by a moderate concentration of platelets, in the absence of leukocytes.

This absence of leukocytes is based on the fact that they synthesize matrix metalloproteinases, free radicals, and proinflammatory cytokines, which do not contribute and even impair the altered tissue regeneration Aim of the Study:To report the structural and visual outcomes of plasma rich in growth factors in closure of challenging macular holes

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Challenging FTMH which include Recurrent macular holes Persistent(refractory) macular holes Macular holes in eyes with pathological myopia Large macular holes with an inner diameter of more than 650 µm

Exclusion Criteria:

* 1-Corneal opacities 2-Glaucomatous patients 3-Co-existing macular pathology ( e.g. diabetic retinopathy, vein occlusion and age related macular degeneration ) 4-History of PPV for any reason other than FTMH
Efficacy, Safety and PK of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo in the Symptomatic Treatment of SAR

Evaluate the relative efficacy of four dosing regimens of bilastine tablets (given either once or twice per day) versus placebo in patients with Seasonal Allergic Rhinitis (SAR) in the Mountain Cedar season in south Texas and Oklahoma based on the mean change from baseline in Reflective Total Nasal Symptom Scores (TNSS) assessed over 14 days of treatment.


Eligibility Criteria:
Inclusion Criteria:

* clinical history of Seasonal Allergic Rhinoconjunctivitis with seasonal onset and offset of nasal allergy symptoms
* documentation of a positive skin test within one year of screening to Mountain Cedar allergen

Exclusion Criteria:

* significant medical condition
* significant nasal abnormality
* significant cardiac condition
* recent infection
* use of other allergy medication during the study