cyrilzakka/clinical-trials huggingface dataset:
Medial Patellofemoral Ligament Reconstruction: A Review of Technique, Accuracy, and Outcome

The purpose of this retrospective study was to determine the accuracy of femoral tunnel placement utilizing Redfern et al's radiographic method for anatomic femoral attachment during MPFL reconstruction in addition to the resultant outcome.

Reconstruction of the medial patellofemoral ligament (MPFL) has been shown to be an effective treatment for recurrent patellar instability, There has been some concern in the literature about the accuracy of femoral tunnel placement and the effect that it might have on patient outcomes.

The investigators evaluated the accuracy of MPFL placement using an intraopetative fluoroscopy technique and to assess subsequent patient outcomes.

All patients undergoing MPFL reconstruction using an intraoperative fluoroscopically guided technique between 2005 and 2010 were identified. A retrospective review of their charts and radiographs were performed and the subjects were brought back for a follow up exam, radiographic series, and Kujala questionaire.

Eligibility Criteria:
Inclusion Criteria:

* Patients having undergone the MPFL procedure, starting January 1, 2005 through February 3, 2010
* Minimum follow up of 24 months

Exclusion Criteria:

* Pregnant women
* Under 18 years of age
* Previously undergone prior MPFL surgery
* Participated in any previous research studies involving the use of ionizing radiation (either radioisotopes or diagnostic x-rays during the past 12 months.
* The participant should not volunteer for other research studies involving the use of ionizing radiation within 12 months of completing the current study.
Compass Course: Efficacy Study

The Compass Course is an 8-session progressive structure that was developed based on theoretical and scientific evidence from psychology and occupational therapy. The goal of the intervention is to provide participants with information, tools, and support that help them move towards reclaiming a sense of self-grounded purpose in daily life. The study will use a convenience sample of breast cancer survivors to evaluate the efficacy of the Compass Course intervention.


Eligibility Criteria:
Inclusion criteria:

1. 25 years of age or older
2. Completed treatment (such as chemotherapy, radiation, surgery) for Stage 0, 1, 2, or 3 breast cancer at least 2 months prior to participating in the Compass Course intervention
3. English speaking
4. High school diploma or GED
5. Able to see, hear, speak (with or without assistive devices)
6. Able to provide own transportation to sessions
7. Willing and able to commit to attend all 8 intervention sessions

Exclusion criteria (all self-reported):

1. Stage 4 breast cancer or any other stage 4 cancer
2. Actively receiving chemotherapy or radiation treatments for cancer. (However, patients may be on Herceptin and/or endocrine treatment and participate in the study.)
3. History of neurologic disorder (such as stroke or brain injury) with residual impairments that likely interfere with learning
4. Any medical condition (physical or mental health) that interferes with the performance of everyday activities and roles.
Smoking Cessation E-Visit

The goal of this study is to develop, refine, and complete preliminary feasibility testing of a smoking cessation electronic visit (e-visit) for implementation in primary care/family medicine. The investigators will conduct a feasibility RCT (N=51) of the smoking cessation e-visit as compared to treatment as usual (TAU), delivered via primary care, with primary objective to provide effect size estimates for a larger RCT. Primary outcomes cluster around: 1) treatment feasibility, 2) treatment acceptability, 3) treatment satisfaction, 4) evidence-based cessation treatment utilization, and 5) cessation-related outcomes (quit attempt incidence, abstinence). It is hypothesized that participants randomized to the e-visit condition as compared to those randomized to the TAU condition will have higher rates of cessation treatment utilization (medications, counseling) and superior cessation-related outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. current smoking, defined as smoking 5+ cigarettes/day, for 20+ days out of the last 30, for the last 6+ months
2. age 18+
3. enrolled in Epic's MyChart program or willing to sign up for MyChart
4. possess a valid e-mail address that is checked daily to access follow-up assessments and MyChart messages
5. English fluency

Exclusion Criteria:

None
Healing of Persistent Epithelial Defects

The purpose of this study is to compare the relative efficacy of four different treatment modalities (i.e. aggressive lubrication, bandage contact lens, Ambiodisk amniotic membrane, Prokera amniotic membrane) in the healing of persistent corneal epithelial defects following retina surgery.


Eligibility Criteria:
3.1 Inclusion Criteria

* Adults aged 18 and older (inclusive) at the time of study enrollment
* Recent history of retina surgery
* Presence of persistent epithelial defect 7 days or later after surgery
* English speaking

3.2 Exclusion Criteria

* Non-English speaking patients
* Inability to incapacity to provide consent for the study
* History of corneal epithelial or limbal stem cell disease
Efficacy Study: Darbepoetin Alfa for the Treatment of Anemia in Patients With Chronic Kidney Disease

The purpose of this study is to evaluate whether the efficacy of darbepoetin alfa SF is equivalent to that of darbepoetin alfa RB for the treatment of anemia in patients with chronic kidney disease (CKD) receiving hemodialysis.


Eligibility Criteria:
Inclusion Criteria: - Diagnosis of CKD and receiving hemodialysis for greater than or equal to 3 months before enrollment - No prior exposure to EPREX® or NeoRecorman® - Baseline hemoglobin (Hb) between 10 and 13 g/dL - On stable weekly or once every other week intravenous (IV) or subcutaneous (SC) darbepoetin therapy for at least 6 weeks prior to screening (stable is defined as less than 25% change in weekly dose and no change in frequency) - Adequate iron stores (serum ferritin equal to or greater than 100 mg/L) - Before any study-specific procedure, the appropriate written informed consent must be obtained Exclusion Criteria: - Scheduled to receive a kidney transplant - Uncontrolled hypertension, defined as a pre-dialysis systolic blood pressure (BP) greater than 180 and/or diastolic BP of greater than 110 - Acute myocardial ischemia; hospitalization for congestive heart failure, myocardial infarction, deep vein thrombosis, cerebrovascular event (stroke or transient ischemic attack) within 12 weeks before enrollment - Parathyroid hormone (PTH) level greater than 1500 pg/mL - Major surgery within 12 weeks before enrollment (excluding vascular access surgery) - Currently receiving antibiotic therapy for systemic infection - Known positive HIV antibody or positive hepatitis B surface antigen - Clinical evidence of current malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia - Red blood cell (RBC) transfusions within 8 weeks before enrollment - Androgen therapy within 8 weeks before enrollment - Systemic hematologic disease (e.g., sickle cell anemia, myelodysplastic syndromes, hematologic malignancy; myeloma; hemolytic anemia) - Any disorder that may impact (in the judgment of the investigator) the ability to give informed consent for participation in this study - Pregnant or breast-feeding women. All subjects must practice adequate contraception (in the judgment of the investigator) throughout this trial. - Treatment with an investigational agent or device within 30 days before enrollment or scheduled to receive an investigational agent other than those specified by this protocol during the course of this study - Subject has known sensitivity to any of the products to be administered during dosing.
The Relationship Between Leisure Activities and Aging Anxiety in Women

The goal of this observational study is to learn about the effect of leisure activities on aging anxiety of middle-aged (45-59) women. The main question it aims to answer is: Do the leisure activities (doing sports, playing music instruments, doing handicrafts, writing, taking care of a pet, growing plants, dancing etc.) affect the aging anxiety level of middle-aged women? Participants will be required to fill out a form querying their socio-demographic information, medical histories, and regular leisure activities. Subsequently, the "Aging Anxiety Scale for Middle-Aged Women" will be applied.

In this study, women aged between 40 and 59 registered at the Marmara University Education Family Health Center (FHC) in the Tuzla district will be included. There are a total of 352 women in this age range registered with the FHC, and it is aimed to reach all of them.

Patients will be informed about the study by Dr. Buğu Usanma Koban via telephone, and they will be invited to the FHC for the administration of the questionnaire. After obtaining informed consent from those who agree to participate in the study, their personal information will be recorded through a face-to-face interview. Subsequently, the Aging Anxiety Scale for Middle-Aged Women, developed by Lee and You, and validated in Turkish by Aydın and Kabasakal, will be applied to the participants.

Finally, volunteers will be asked to fill out a questionnaire specifying the types and frequencies of their leisure activities. SPSS (version 20.0, SPSS Inc., Chicago, IL, USA) will be used for data analysis.

Descriptive statistical information will be presented as mean ± standard deviation or %, and a p-value less than 0.05 will be considered statistically significant. In the comparison of more than two independent groups that do not meet the assumptions of parametric tests, the Kruskal-Wallis analysis will be conducted. If the analysis is significant, groups will be subjected to pairwise Mann-Whitney U tests.

To understand the relationship between leisure activities and aging anxiety, Spearman Correlation Analysis will be conducted for parameters conforming to normal distribution, and Pearson Correlation Analysis will be performed for parameters not conforming to normal distribution. The correlation coefficient (r value) will be specified.

Eligibility Criteria:
Inclusion Criteria:

* Not having a medical condition that requires urgent intervention or hospitalization
* Not having psychological or physical barrier preventing communication.

Exclusion Criteria:

* a medical condition that requires urgent intervention or hospitalization
* having a psychological or physical barrier preventing communication.
Development of a Mobile Health Intervention for Electronic Cigarette Use Among Young Adults

Electronic Nicotine Delivery Systems (ENDS) use remains prevalent among young adults, and many have high interest in quitting, yet research on effective intervention is lacking. A mobile health (mHealth) intervention that translates effective smoking cessation materials and pharmacotherapy may be a promising avenue for intervention. The initial phase of the proposed study uses a pilot study to evaluate a novel mHealth intervention for young adult ENDS and dual product (ENDS and combustible cigarette) users.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-26 years old, ability to understand the English language, willing and able to provide informed consent
2. Current ENDS user (at least 4 out of 7 days per week of use for the past one month); for focus groups, at least half of participants will report current cigarette smoking (at least 1 cigarette per day on at least 1 day per week in the past month)
3. Report interest in quitting or reducing ENDS (at least 6/10 scale in interest of quitting or reducing
4. Does not currently (in past one year) meet criteria for major psychiatric disorder including severe alcohol or substance use disorder (excluding tobacco use disorder), schizophrenia, bipolar disorder, and obsessive compulsive disorder
5. For women, not currently pregnant, planning to become pregnant, or breastfeeding due to lack of information on ENDS use and possible harms from NRT during pregnancy
6. Not currently using smoking cessation medication (i.e., Varenicline, Bupropion
7. No history of adverse reactions to nicotine replacement therapy

Exclusion Criteria:

1. Does not own a mobile phone or is unwilling to receive text messages to their device
2. No interest in quitting or reducing use of ENDS
3. Uses electronic cigarettes less than 4 days per week in the past month
4. Reports past-year serious psychiatric illness, including severe alcohol or substance use disorder (excluding tobacco use disorder), schizophrenia, bipolar disorder, and obsessive compulsive disorder
5. Is currently using smoking cessation medication including Varenicline or Bupropion
6. Are a female who is currently pregnant or nursing or planning to become pregnant within the next 6 months
Pelvic Floor Function After Obstetric Injury to the Anal Sphincter

The goal of this observational study is to learn more about the effect a pregnancy and delivery has on the function of the anal musculature.We will compare women who had a new delivery after suffering a severe tear in the anal musculature in their first pregnancy, with women who had two or more vaginal deliveries, but did not suffer such an injury.

The main questions we want to answer is:

* can the burden of a new pregnancy and delivery weaken the function of the repaired musculature in a way that might cause symptoms of anal incontinence later in life?
* can a tear in the anal musculature increase the risk of developing urinary incontinence and long term sexual dysfunction?
* should we recommend these women to have a caesarian section instead of a new vaginal delivery?

Participants will be asked to complete an electronic questionnaire with information regarding their pregnancies, deliveries and potential symptoms from anal incontinence, urinary incontinence and sexual dysfunction.

Researchers will compare these two groups to find out if a new vaginal delivery has a negative effect on the function of the anal musculature.


Eligibility Criteria:
Inclusion Criteria:

* Sphincter group: Previous obstetric anal sphincter injury during vaginal childbirth in 2002-2018 and having a subsequent vaginal delivery without such injury
* control group: Two or more vaginal deliveries without obstetric anal sphincter injury

Exclusion Criteria:

* under 18 years
* consent incompetency
* Obstetric anal sphincter injury in subsequent pregnancies
* caesarian section in subsequent pregnancy
An fMRI Study of Satiation in Healthy Volunteers.

To our knowledge no study has assessed the effects of a meal on neural responses to food cues and compared this with a condition simulating natural inter-meal hunger levels. This is important, as the existing literature often compares the effect of fasting to satiation, which may not reflect typical appetite processes. Thus, the purpose of this research was to examine the effect of a satiating lunch compared to a normal pre-meal state on blood oxygen level dependent (BOLD) activity in the human brain, as measured using functional magnetic resonance imaging (fMRI).

We hypothesized that satiation would be associated with decreased brain activity across brain regions involved in both appetite and reward such as ventromedial prefrontal cortex, orbitofrontal cortex, ventral striatum, hypothalamus, insula, amygdala and hippocampus. 16 healthy participants (8 males) were scanned on two separate test days, before and after eating a meal to satiation, or after not eating for 4 hours (satiated vs. pre-meal). fMRI BOLD signals to the sight and/or taste of the stimuli were recorded. Participants were given questionnaires to complete about their mood state and appetite before and after all scans.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Sufficiently fluent in English to understand the task and the instructions

Exclusion Criteria:

* Currently taking medication
* Past or current depression/dieting,
* Smokers
* Food allergies
* Diabetes
* Pregnancy
* BMI score outside the normal range
* Any contraindications to fMRI scanning (e.g. pacemakers, mechanical heart valve, hip replacement, metal implants)
Effect of Acute Exercise on Cognitive Functions and Blood Markers of Brain Plasticity in Regular Chronic Cannabis Users

The endocannabinoid system (ECS) is a complex endogenous signaling system made up of transmembrane cannabinoid receptors (CB1 and CB2 receptors), their endogenous lipid-derived ligands (the endocannabinoids - eCBs), and enzymes for ligand biosynthesis and degradation. Interestingly, exercise increase plasma AEA, one of the most famous endocannabinoid. This increase could be involved in exercise-induced neurogenesis and other beneficial exercise adaptations. Chronic cannabis use is associated with alteration of ECS activity. The aim of the study is to compare ECS response to exercise between chronic cannabis users and non-users.


Eligibility Criteria:
Inclusion Criteria:

Cannabis consumer group:

* Cannabis consumption \> 100 times in lifetime, last exposure \< 7 days, and recent exposure \> 10 times in the month.
* Positive toxicological urine test for ∆-9-THC.
* Having a cannabis use disorder according to the DSM-5 (cannabis abuse disorder).

Healthy group:

* Negative urine toxicological test for cannabis.
* No regular cannabis use for more than 6 months once in a lifetime.
* No cannabis consumption in the 6 months preceding the study.

Exclusion Criteria:

For all subjects :

* Disorders of use of other substances (alcohol, cocaine, opioid, or synthetic drugs).
* Alcohol consumption greater than 30g per day (averaged over one week) and/or alcohol abuse the week preceding the visit.
* Under medical treatment.
* Presence of diagnosed neurological disorders.
* Diagnosis of a psychotic picture entering axis I, DSM-5.
* Chronic progressive disease or in remission.
* Body mass index \> 30 kg/m2 (i.e. presence of obesity).
A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation

The primary purpose of the study is to demonstrate that dapoxetine can prolong intravaginal ejaculatory latency time (IELT) compared with placebo in men with premature ejaculation (PE).

One form of male sexual dysfunction is premature ejaculation (PE), which is also referred to as rapid ejaculation (RE). The study consists of 2 phases: pre-randomization phase (a screening visit and a 2-week baseline period); 12-week double-blind treatment phase during which patients will receive one of 2 doses of dapoxetine or placebo for use on an "as-needed" basis. The total duration of the study is approximately 14 weeks. Assessments of effectiveness include the average intravaginal ejaculatory latency time (as measured by stopwatch) during sexual intercourse, during the treatment period; control over ejaculation, participant and partner satisfaction with sexual intercourse, participant overall impression of change and severity of symptoms, based on questions asked at monthly intervals through the treatment phase. Safety assessments include the incidence, severity, and type of adverse events during the study, ECGs, as well as laboratory tests. At the end of the baseline period, patients from selected study centers will undergo blood sampling and ECG monitoring before and after the first dose of study medication. The study hypothesis is that treatment for 12 weeks with dapoxetine prolongs intravaginal ejaculatory latency time, compared with placebo, in men with PE. Oral tablets of dapoxetine (30 milligrams \[mg\] or 60mg) or placebo taken as needed during 12 weeks of treatment. No more than 1 dose within a 24-hour period.

Eligibility Criteria:
Inclusion Criteria:

* Patient is in a stable, monogamous sexual relationship with the same woman for at least 6 months and plans to maintain this relationship for the duration of the study
* history of premature ejaculation in the 6 months before study initiation not due to distress, interpersonal difficulty or medication withdrawal
* history of intravaginal ejaculatory latency time (IELT) of \< = 2 minutes in at least 3 out of 4 events
* blood pressure \< = 180/100 mmHg at screening and end of baseline
* patient and partner must agree to attempt sexual intercourse at minimum intervals specified in the protocol
* patient's partner must have a negative urine pregnancy test at time of screening

Exclusion Criteria:

* Not taken dapoxetine in a previous investigational drug study
* not using other forms of therapy for treatment of PE (behavioral therapy or medications applied to the skin)
* no history of any medical events that are associated with the development of PE
* not taken another investigational drug within 1 month
* no history of seizures or major psychiatric disorder such as depression or schizophrenia
* no alcohol abuse and dependence
* no known allergy or hypersensitivity to dapoxetine or other selective serotonin reuptake inhibitors (SSRIs)
* no partners with decreased interest in or painful intercourse or other forms of sexual dysfunction
Study to Evaluate the Combination of Enteric-coated Mycophenolate Sodium (EC-MPS), Basiliximab, and C2-monitored Cyclosporine in de Novo Renal Transplant Recipients at Potential High Risk of Delayed Graft Function (DGF)

The aim of the study is to assess the short-term benefit of the combination of basiliximab, EC-MPS and cyclosporine microemulsion with C2 monitoring on the prophylaxis of acute rejection in a population of de novo renal transplant patients at potential high risk of DGF.


Eligibility Criteria:
Inclusion Criteria:

- Age 18-70 years old

* Patients receiving a primary or secondary cadaveric or living donor kidney
* Patients who have given written informed consent for study participation
* Females capable of becoming pregnant must have a negative pregnancy test at baseline and are required to practice birth control for the duration of the study and at least for four months following the last dose of basiliximab.

Exclusion Criteria:

* Recipient of multi-organ transplants or previously transplanted organs other than kidney
* Recipient of dual kidney transplants
* Recipient of a transplanted kidney from a Non-Heart Beating Donor (NHBD)
* Recipient of a HLA identical living-donor kidney
* Patients with a PRA level (past or current level) greater than 20%
* Patients anticipated by investigators to require induction therapy with OKT3, ATGAM, or Thymoglobulin for any reason
* Patients with any medical condition which, in the opinion of the investigator, would preclude the patient from participating in the study
* Cold ischemia time larger than 36 hours.
* Patients who have received an investigational drug or therapy within one month prior to study entry or if such therapy is to be instituted post-transplantation.
* Female transplant candidates who are pregnant, lactating, or of childbearing potential and not willing to practice an acceptable method of contraception
* Patients with a known hypersensitivity to cyclosporine
* Patients with a known malignancy or a history of malignancy, other than successfully treated non-metastatic basal or squamous cell carcinoma of the skin
* Known HIV positive antibody status
* Evidence of any clinically relevant (per investigator determination) active infection
* Patients unable to participate in the study for the full 3-month study period
* Other protocol-defined exclusion criteria may apply.