cyrilzakka/clinical-trials huggingface dataset:
Impact Evaluation of MotherWise Program

Mathematica was awarded a contract by ACF to conduct the evaluation of selected grantees offering Healthy Marriage and Relationship Education Programs.This particular evaluation will focus on the University of Denver's MotherWise program, which offers relationship education and other supports to low-income women expecting a baby. The program has three core components: (1) 18 hours of core workshop sessions using the Within My Reach relationship education curriculum supplemented with content on mother-infant relationships; (2) case management services; and (3) optional relationship education workshops for couples. The evaluation will test the effect of this full package of services on mothers' relationship outcomes, as well as other outcomes related to child well-being, such as co-parenting and father involvement.

The U.S. Department of Health and Human Services (HHS), Administration for Children and Families (ACF), is conducting an evaluation of healthy marriage and relationship education (HMRE) programs. Mathematica was awarded a contract by ACF to conduct the evaluation of selected programs/grantees.This segment of the larger evaluation will focus on the University of Denver's MotherWise program.

The Mother Wise program will offer relationship education and other supports to low-income women expecting a baby. The program will have three core components: (1) 18 hours of core workshop sessions using the Within My Reach relationship education curriculum supplemented with content on mother-infant relationships; (2) case management services; and (3) optional relationship education workshops for couples. The evaluation will test the effect of this full package of services on mothers' relationship outcomes, as well as other outcomes related to child well-being, such as co-parenting and father involvement. If feasible, the evaluation will also examine some measures available through hospital records, such as birth weight.

Mother Wise will enroll women who are expecting a baby and those who have had a baby within the past month.

Control group members will not be eligible for Mother Wise but will be eligible for other services available in the community.

To document the outcomes of study participants, survey data will be collected at two time points: (1) a baseline survey administered at study enrollment, a (2) a 12-month follow-up survey, and (3) a 30-month follow-up survey. Surveys will be conducted by staff at Mathematica's Survey Operations Center using computer-assisted telephone interviewing (CATI). Survey data may be supplemented with administrative records data from the Denver Health system.

Eligibility Criteria:
Inclusion Criteria:

To be eligible, women must be expecting a baby or had a baby in the past 3 months.

Exclusion Criteria:

To be eligible, women must not be incarcerated.
Feasibility of Mindfulness Meditation for Adults 65+ With Chronic Low Back Pain

This pilot feasibility experimental study is designed as a randomized wait-list controlled trial of mindfulness meditation for CLBP. A sample of 37 older adults 65 years of age and older will be recruited from a chronic pain clinic, posted flyers, and newspaper advertisements over a 6-month period. Eligibility will be determined by self-report from a checklist reviewed with potential participants over the phone (see appendix for checklist). Pre-intervention study participants will be consented and study measures obtained. After consent and baseline measures, participants will be randomized in blocks of six using a simple randomization process with no stratification using a table of random numbers. After randomization, participants in the intervention group will receive the intervention of eight weekly 90-minute mindfulness meditation sessions. Instead of waiting until all 37 participants have been recruited into the study to do the intervention, the intervention will be done on a rolling basis. This means there will be a minimum of 6 participants per intervention group, with the possibility of three separate intervention groups. If recruitment goes better than expected, then we will offer the intervention to all 18 participants at one time. Controls will not receive any intervention during this time. Immediately post-intervention the measures will be administered again to participants and wait-list controls. Once the intervention is complete and participants and wait-list controls have completed post-intervention measures the mindfulness meditation program will be offered to the wait-list controls. We will try to combine the wait-list controls into one eight-week program. 3 months after the intervention is completed, participants will be asked to complete the measures a third time and any mindfulness meditation they continue to do at home will be quantified.

The primary hypotheses are:

1. We expect to be able to recruit 37 eligible individuals with CLBP into the study within a six-month period.
2. We expect participants randomized to the mindfulness meditation intervention to meet an adherence standard of attending 75% of the 8 weekly 90-minute sessions.
3. We expect mindfulness meditation will result in a moderate effect size difference (0.5) between the intervention participants and wait-list control participants on outcome measures of pain, mood, physical function, attention, and QOL.


Eligibility Criteria:
Inclusion Criteria:

All participants will be included if they are:

1. 65 years of age or older,
2. have intact cognition (Mini-Mental Status Exam (MMSE) \>23),
3. CLBP, defined as moderate pain occurring daily or almost every day for at least the previous three months, and
4. speak English.

Exclusion Criteria:

They will be excluded if they:

1. do not meet the above inclusion criteria,
2. have previously participated in a mindfulness meditation program, and
3. have serious underlying illness (like malignancy, infection, unexplained fever, weight loss or recent trauma) causing their pain.
Houston Emergency Opioid Engagement System

The Houston Emergency Response Opioid Engagement System (HEROES) is a community-based research program integrating assertive outreach, medication-assisted treatment, behavioral counseling, peer recovery support, and paramedic follow-up in Houston Texas. The objective is to compare differences in engagement and retention in treatment for individuals with opioid use disorder.

The Houston Emergency Response Opioid Engagement System (HEROES) is a non-randomized cohort study based at the University of Texas Health Science Center of Houston. This study seeks to develop an emergency- initiated opioid system of care for individuals with prior opioid overdose and opioid use disorder. The study involves both assertive outreach on individuals who have recent overdoses within the last 72 hours, as well as individuals who are admitted to local hospital emergency departments. The study explores the effect of the combination of assertive outreach, same-day induction into medication-assisted treatment, ongoing maintenance treatment, behavioral counseling, peer recovery support, and paramedic follow-up on patient outcomes. The primary outcome is engagement and retention outpatient treatment. Secondary outcomes include quality of life assessment as well as subsequent relapses and overdoses. The hypothesis is that patients with earlier induction into MAT treatment in the emergency department, who receive routine follow-up, are more likely to engage and be retained in a longer-term treatment program for their addiction.

Eligibility Criteria:
Inclusion Criteria:

* In otherwise good health based on physician assessment and medical history
* Tests positive in urine sample for opioids
* Patients express a willingness to stop opioid use
* Meet Diagnostic and Statistical Manual of Mental Disorders - Text Revision (DSM-IV-TR) criteria for opioid dependence
* Patients must be able to speak English
* Be agreeable to and capable of signing informed consent

Exclusion Criteria:

* Non-English-speaking patients
* Have a known sensitivity to buprenorphine or naloxone
* Be physiologically dependent on alcohol, benzodiazepines or other drugs of abuse that require immediate medical attention. Other substance use diagnoses are not exclusionary.
* Have a medical condition that would, in the opinion of the study physician, make participation medically hazardous, including unstable cardiovascular disease, neurological deficits, trauma, acute hepatitis, stroke, and liver or renal disease)
* Be acutely psychotic, severely depressed, and in need of inpatient treatment, or is an immediate suicide risk
* Be a nursing or pregnant female
The Effectiveness of Prophylactic Antibiotics for Urethral Bulking

The goal of this clinical trial is to evaluate if prophylactic antibiotics in urethral bulking are effective in reducing postprocedural urinary tract infections.

Urethral bulking is a minimally invasive surgical treatment option for stress urinary incontinence (SUI). One commonly reported post-procedural complication is urinary tract infection (UTI). UTI rates are variable where studies have reported rates from as low as 0% to as high as 40%. Along with this variability, the instructional inserts for various bulking agents have inconsistent recommendations for use of prophylactic antibiotics. The American Urologic Association recommends antimicrobial prophylaxis for cystourethroscopy procedures involving minor manipulation. Currently, there are no clear guidelines regarding the utility of prophylactic antibiotics for urethral bulking. The objective of our study is to determine the effectiveness of prophylactic antibiotics in urethral bulking for reducing post procedural UTIs.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo a urethral bulking procedure
* Age 18 ≥ over

Exclusion Criteria:

* History of recurrent urinary tract infections
* Known history of urinary retention
* Allergies or contraindications to multiple antibiotics
* Inability to tolerate oral antibiotics
* Concomitant surgical procedures at the time of urethral bulking
* Pregnant or breastfeeding
LDK378 in Adult Patients With ALK-activated NSCLC Previously Treated With Chemotherapy and Crizotinib

A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anti-cancer therapy and/or died. LDK378 could be continued beyond RECIST-defined progressive disease (PD) as assessed by the investigator if, in the judgment of the investigator, there was evidence of clinical benefit. In these patients tumor assessment would continue as per the schedule of assessments until treatment with LDK378 was permanently discontinued. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator


Eligibility Criteria:
Inclusion critieria:

* Histologically or cytologically confirmed diagnosis of stage IIIB or IV NSCLC that carries an ALK rearrangement, as per the FDA-approved FISH assay (Abbott Molecular Inc.).
* Age 18 years or older at the time of informed consent.
* Patients must have NSCLC that has progressed during therapy with crizotinib or within 30 days of the last dose
* Patients must have received 1-3 lines of cytotoxic chemotherapy (of which 1 must have been a platinum doublet) to treat their locally advanced or metastatic NSCLC
* Patients must have a tumor tissue sample available, collected either at the time of diagnosis of NSCLC or any time since.
* Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 2, except for patients with grade 2 nausea/vomiting and/or grade 2 diarrhea despite optimal supportive therapy who will not be allowed to participate in the study.

Exclusion criteria:

* Patients with known hypersensitivity to any of the excipients of LDK378.
* Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
* History of carcinomatous meningitis.
* Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
* Clinically significant, uncontrolled heart disease
* Systemic anti-cancer therapy given after the last dose of crizotinib and prior to starting study drug.
Laparoscopic Approach to Cancer of the Endometrium

The primary objective of this study is to assess disease-free survival at 4.5 years postoperatively for women with apparent Stage 1 endometrial cancer, comparing patients who are randomised to receive Total Laparoscopic Hysterectomy (TLH) and patients who are randomised to receive Total Abdominal Hysterectomy (TAH).

This phase III international, multicenter, open-label, randomized clinical trial is an equivalence study with the hypothesis is that Total Laparoscopic Hysterectomy (TLH) is associated with equivalent disease-free survival when compared to the standard treatment of Total Abdominal Hysterectomy (TAH) for women with apparent Stage I endometrial cancer.

The secondary hypotheses are:

* TLH is associated with equivalent or improved Quality of Life (QoL) at 6 months;
* TLH is associated with reduced treatment-related morbidity;
* TLH is associated with shorter hospital stay;
* TLH is associated with less analgesic consumption;
* TLH is cost effective;
* TLH is associated with improved pelvic floor function.

Eligibility Criteria:
Inclusion Criteria:

Patients who may be included for this study must have the following:

* Histologically confirmed primary endometrioid adenocarcinoma of the endometrium;
* Clinical stage I disease;
* ECOG Performance status of 0-1;
* Signed written informed consent;
* Females, aged 18 years or older.

Exclusion Criteria:

Patients will be excluded from participating from the study if they have any of the following:

* Other histologic type than endometrioid adenocarcinoma of the endometrium;
* Clinically advanced disease (stages II-IV);
* Uterine size larger than 10 weeks gestation;
* Estimated life expectancy of less than 6 months;
* Enlarged aortic lymph nodes;
* Unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
* Patient compliance and geographic proximity that does not allow adequate follow-up;
* Unfit to complete QoL measurements.
Contributing Factors to Anterior Resection Syndrome and Its Impact on Quality of Life: A Retrospective Cohort Study

This study adds to the understanding of the contributing factors leading to LARS, the long term effects of this syndrome post-operatively and its impact on quality of life.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients \>18 years, under the care of all surgical firms at Mater Dei Hospital, who had undergone anterior resection for rectal cancer between January 2014 and December 2016

Exclusion Criteria:

* colorectal cancer (\>15cm) from anal verge
* permanent stoma
* known disseminated or recurrent disease,
* patient without restitution of bowel continuity after 1 year
Periacetabular Osteotomy.A Prospective Study With Reference to Cartilage, Migration and Bone Density

The purpose of this study is to evaluate the effect of performing a periacetabular osteotomy on patients with hip dysplasia.

The cause of osteoarthritis in hip dysplasia is thought to be attributable to increased joint contact pressures secondary to decreased acetabular coverage of the femoral head and/or incongruity of the articular surfaces. The investigators' hypothesis is that when periacetabular osteotomy is performed and contact pressure on cartilage reduced, additional joint degeneration will be slowed or prevented unless irreparable damage to the cartilage has happened at the time periacetabular osteotomy is performed. Hence, the purposes of this study are:

* to develop an unbiased and precise method for measurement of the thickness of the articular cartilage in the hip joint because such a method can be used to evaluate the effect of periacetabular osteotomy and also to give a more precise indication/contraindication for surgery;
* to evaluate the migration of the acetabulum postoperatively and 6 months after surgery by use of RSA to examine the stability of the osteotomy; and
* to examine bone mineral density in acetabulum 1 and 2 years after surgery in order to find out whether the change in load distribution will affect bone density of the acetabulum over time in a way that in the area where more load is applied, bone density will increase, and in areas with less load, bone density will decrease;
* to examine the labrum in the hip joint.

Eligibility Criteria:
Inclusion Criteria:

* Patients with radiologically diagnosed hip dysplasia (CE-angle \< 25°)
* Patients with osteoarthritis graded 0, 1 or 2 defined according to Tönnis' classification
* Patients with pain from hip
* Age \> 18 years
* Minimum 110° flexion in hip joint and closed growth zones in the pelvic region
* Informed consent

Exclusion Criteria:

* Patients with neurological diseases
* Patients with calvé-Legg-Perthes syndrome
* Patients where a femoral intertrochanteric osteotomy is necessary
* Patients with medical sequelae after earlier hip surgery
* Females who are pregnant
* Patients with metal implants
Alpha-lipoic Acid in Critically Ill Patients With Sepsis

Evaluate the of effect of alpha-lipoic acid in critically ill septic patients. 60 septic patients will be enrolled from Damanhur National medical institute, and they will be randomized using simple randomization into control group will receive placebo and ALA group will be given 1800 mg orally or via a nasogastric tube of ALA daily for seven days .

1. Ethical committee approval will be obtained from ethics committee of Faculty of Pharmacy, Damanhour University \& Ethics committee of Damanhur National Medical National Institute.
2. All participants or their relatives should agree to take part in this clinical study and will provide informed consent.
3. 60 septic patients will be enrolled from Damanhur National medical institute, and they will be randomized using simple randomization into control group will receive placebo and ALA group will be given 1800 mg orally or via a nasogastric tube of ALA daily for seven days .
4. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
5. Results, conclusion, discussion and recommendations will be given. Outcomes 1. The primary outcome ICU and hospital mortality, ICU and hospital stay, new acute kidney injury in ICU, demand and duration of life support, Sequential Organ Failure Assessment (SOFA)/Acute Physiology and Chronic Health Evaluation II (APACHE II) 2. The secondary outcome are as follows: A. 28-day all-cause mortality B. change in inflammatory markers such as CRP , IL6, and TNF Alpha and may be measured glycocalyx degradation markers such as syndecan 1.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will be diagnosed with sepsis or develop sepsis during their ICU length of stay
* Age 18 year and older
* Patient able to receive oral or enteral medication

Exclusion Criteria:

* Patients who will be diagnosed with septic shock
* Female patients who are pregnant or lactating.
* Participation in another clinical trial.
* Current treatment with other medications that have antioxidant effects, such as vitamin C and vitamin E.
* Allergy to LA or similar active agents (e.g., vitamin B), or previous intolerance to the recommended dose of LA
Age-Related Effects of THC

Increased accessibility to cannabis and its primary psychoactive constituent THC has raised public health concerns. One major concern surrounds the potential risks associated with acute THC intoxication and who might be most at risk. A second major concern is the need to develop sensitive measures that can detect THC intoxication after recent use and enable robust comparisons of intoxication to determine sources of risk. One potential source of risk is age, specifically during the period of adolescence.

There is limited knowledge on the effects of THC in adolescents vs adults. One recent report compared responses to vaporized cannabis in heavy adolescent vs adult cannabis users and found that the adolescents were less sensitive to the drug on most measures. However, their findings were complicated by several factors: i) the study used vaporized cannabis, which may have other constituents and does not offer full control of the dose, ii) the participants were heavy users, making it difficult to determine the influence of prior drug exposure, and iii) the participants were not drug-free at the time of testing. Prior exposure to THC can lead to tolerance, and adolescents and adults may differ in the rate at which they develop tolerance, consistent with changes in CB1R receptor function. Our study will compare adolescent (here, aged 18 to 20) and adult (here, aged 30 to 40) responses to THC in relatively light cannabis users who are drug-free at the time of testing.

Eligibility Criteria:
Inclusion Criteria:

* 18-20 years old OR 30-40 years old
* Body Mass Index 19-26
* High school education, fluent in English
* Occasional cannabis users ( 0 times in past 30 days AND used cannabis no more than 20 times in lifetime)

Exclusion Criteria:

* History of daily cannabis use
* Past or present severe substance use disorder
* Current or past diagnosis with drug treatment for psychosis/bipolar/schizophrenia
* Cardiovascular illness, high blood pressure, abnormal electrocardiogram
* Current medications
* Pregnant or planning to become pregnant
Platelet Rich Plasma Injection Into Ovary of Patients With Premature Ovarian Insufficiency

All encountered cases with POI will be assessed and examined then investigated. Eligible cases will be included in the study

Patients will be subjected to injection of autologous PRP inside the ovary about 0.5-1 mml by laparoscopy

Eligibility Criteria:
Inclusion Criteria:

* Premature ovarian insufficiency diagnosed by:
* FSH\> 40 Amenorrhea Menopuasal symptoms Infertility

Exclusion Criteria:

* Refusal to participate Secondary POI due chemotherapy, surgery, or radiotherapy Previous treatment with PRP
The Impact of Social Phone Calls on Adults Who Have Had a Stroke

The purpose of this study is to see the impact of social visits, through weekly phone calls, on quality of life and health outcomes of depression, anxiety, loneliness, and self-rated health for adults who have experienced an ischemic or hemorrhagic stroke and to determine the benefit of these conversations on the student volunteer's perspective of adults who have survived a stroke


Eligibility Criteria:
Inclusion Criteria:

* have a UCLA short form score of 4 or higher
* can read, write, and speak English
* have had an ischemic or hemorrhagic stroke is the past year
* have a telephone and are available for weekly phone calls
* provide informed consent agreeing to be contacted by the volunteers

Exclusion Criteria:

* reside outside of the home
* have Electronic Health Record documentation of Aphasia
* Montreal Cognitive Assessment score of \<9