cyrilzakka/clinical-trials huggingface dataset:
Advanced Provision of Emergency Contraception: Utilizing Technology to Increase Prescription Fill Rates

Eighty-five percent of the 750,000 teenage pregnancies per year in the United States are unintended (Guttmacher Institute). Approximately half of all teenage pregnancies end in the birth of a child; the remaining proportion end in either abortion (30%) or miscarriage (20%). It has been estimated that if Emergency Contraception (Plan B) was used after every contraception failure, it could prevent 50% of unintended pregnancies and 60-70% of abortions annually.

Previous studies have showed the effectiveness of emergency contraception decreases with time after intercourse; the sooner it is taken-even if it means a matter of hours-the more effective it is in preventing pregnancy. Based on previous studies, it is clear that relying on obtaining emergency contraception on the same day or even the day after unprotected intercourse is not guaranteed. For example, approximately 27% of pharmacies called by the adolescent mystery caller did not have the medication available the day of the call and almost all of the pharmacies not stocking the medication would take greater than 24 hours to obtain it through their ordering system.

Thus, the concept of advanced provision of emergency contraception has been proposed to assure that the medication can be taken as soon as possible. Although this practice is known to be safe and has not shown any association with increased sexual risk or behaviors, it is unclear how often/if adolescents will fill a prescription for a medication that is not needed at the time of a medical encounter.

The investigators propose a randomized pilot study (n=60) of a text-messaging intervention that aims to increase the rate at which prescriptions for emergency contraception are filled. Based on practice norms in the BMC Adolescent Center, sexually active female adolescents (ages 13-21) in both the control and intervention groups will be provided a prescription for emergency contraception. The intervention group, however, will receive follow-up text message on their phone reminding them to fill the prescription.

Boston Medical Center Health Plan will provide prescription fill data regarding the prescriptions written at the time of enrollment. Approximately 6 weeks after enrollment, all study participants will be contacted for a follow-up survey.


Eligibility Criteria:
Inclusion Criteria:

* Sexually Active
* Boston Medical Center Health Plan Insurance
* Personal Cell Phone

Exclusion Criteria:

* Pregnant
* Currently using a long-acting form of contraception (IUD, Depo, Implanon)
* No personal cell phone
* Insurance other than Boston Medical Center Health Plan
Clinical Evaluation of a Cochlear Implant System

The primary objective of this study is to assess the usability of a Cochlear implant system.

Measure participant ratings on satisfaction of a Cochlear implant system via use of validated and non-validated questionnaires.

Eligibility Criteria:
Inclusion Criteria:

1. Eighteen years of age or older
2. At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear
3. At least 3 months experience with the CP810,CP920 or CP910 sound processor
4. Fluent speaker in the language used to assess speech perception performance
5. Willingness to participate in and to comply with all requirements of the protocol
6. Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test

Exclusion Criteria:

1. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device
2. Additional disabilities that would prevent participation in evaluations
3. Nucleus 22 Implant
Development of Stance Control Orthotic Knee Joint For Improvement of KAFO Users

I want to design Stance control orthotic knee joint for improvement of KAFO users which is not available in Pakistan imported stance control orthotic knee joints are very expensive patients can't afford. The aim of my study to develop low cost stance control knee joint and ensure its availablity for KAFO users.


Eligibility Criteria:
Inclusion Criteria:

* Polio Patient
* Proximal tibial fracture.

Exclusion Criteria:

* Patients without KAFO
* Cerebral Palsy Patients
Pre- and Postoperative Use of ZD1839 (Iressa) in Recurrent Glioblastoma, Including Translational Research

This study aims to determine effectiveness of Gefitinib (Iressa) in recurrent glioblastoma after standard treatment (surgery, radiationtherapy and at least a first line chemotherapy). Gefitinib is a specific inhibitor of the epidermal growth factor receptor (EGFR). EGFR is elevated in more than 50% of malignant gliomas. At recurrence, secondary surgery and pre- and postoperative Gefitinib is offered to patients in good performance status. Clinical outcome of patients and correlation to translational research will be evaluated.

Glioblastoma (GBM) patients who relapse and are in good performance status, without serious neurological deficits are offered secondary surgery and participation in the trial. Eligible patients must have had standard treatment including primary surgery, radiation therapy and at least a first line chemotherapy. Patients on cytochrome P450 isoenzyme CYP3A4-inducing antiepileptic drugs (EIAE) are excluded due to ensuing interactions of these drugs with gefitinib metabolism, reducing systemic availability. After giving written informed consent, patients receive gefitinib 500 mg daily starting at least 5 days prior to re-operation, allowing a steady state condition.Treatment continues until tumor progression or occurrence of intolerable side effects.The specimens collected at surgery will undergo translational research, aiming to correlate drug accumulation and molecular signatures of GBM samples with clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* recurrent glioblastoma
* informed consent
* reoperation planned
* fresh frozen sample obtainable

Exclusion Criteria:

* enzyme inducing antiepileptic drugs
* pregnancy or breast feeding
Surgical Treatment for Acute Patella Tendon Rupture

We will compare two groups for acute patella tendon repair: one treated with surgical anchors and the second, with transpatellar tunnels.

The patella tendon is located in the knee, and is attached to the leg bone and the patella bone (knee cap). The quadriceps muscle (an important tight muscle) attaches to the patella bone and allows for extension and flexion of the leg. Rupture of the patella tendon occurs mainly in people under the age of 40 years old with an active lifestyle. Normally, surgical repair is needed to fix this injury. The widely accepted surgery for this injury consists in drilling 2 holes in the patella bone that are used to anchor the patella tendon in place. This surgery has some complications such as re-rupture of the tendon, breakage of the bone, etc. Some investigators have tried different techniques to avoid these complications with variable results. We want to use 2 anchors in the bone to avoid making holes in the patella bone, decreasing complications and surgical time, and hopefully, allowing for a better surgical repair. We will have 2 arms. One group will have the standard of care technique and the second group will have the anchors technique. We will follow up with our patients after the surgery to record their progress, and complications, if any. We will also have a standardized physical therapy program for consistency and to avoid any problems.

Eligibility Criteria:
Inclusion Criteria:

1. Stage of Disease: Acute ruptures of the patella tendon, no more than 3 weeks since the time of injury.
2. Age: 18 years old and up.
3. Performance status: Patients with no other previous illnesses that prevented them to ambulate normally (without help of devices).
4. Informed consent requirements: One person from our research staff will approach the patient after the diagnosis has been made. The diagnosis will be made by the doctor in charge on the patient care based on the medical history, physical exam and image studies (MRI). We will explain the benefits/risks to be part of the study and that they are not obligated to be part of it as part of their care.

Exclusion Criteria:

1. Prior treatment: Patients with chronic patella tendon ruptures (more than 3 weeks).
2. Prior other diseases: diseases with systemic collagen deficiencies.
3. Infection: Patients with active infection will be disqualified.
Effect of Silymarin in Metastatic Colorectal Cancer Patients

this work is aim to assess the antitumor effect of silymarin in patients with metastatic colorectal cancer receiving chemotherapy with or without target therapy (Bevacizumab).

Colorectal cancer (CRC) ranks as the third most common cancer globally and second in terms of mortality . Although CRC incidence rates are higher in high-income compared with low-to-middle-income countries (LMICs), mortality is higher in LMICs.

Extensive research within the last decade has shown that silymarin can suppress the proliferation of a variety of tumor cells; this is accomplished through cell cycle arrest at the G1/S-phase, induction of cyclin-dependent kinase inhibitors, down-regulation of anti- apoptotic gene products, inhibition of cell-survival kinases and inhibition of inflammatory transcription factors (e.g., Nuclear Factor- kappa B) through suppression of Nuclear Factor- kappa B-regulated gene products, including Cyclooxygenase-2, Lipoxygenase, Tumor necrosis factor and Interleukin-1. Silymarin can also down-regulate gene products involved in the proliferation of tumor cells (Epidermal Growth Factor Receptor, Cyclooxygenase-2), invasion (Matrix metallopeptidase 9), angiogenesis (Vascular Endothelial growth Factor) and metastasis (adhesion molecules). Silymarin was reported to alter the expression of apoptosis-related proteins including BCL2 associated X protein to induce apoptosis in human gastric cancer cells in a concentration-dependent manner. Silymarin has also been shown to sensitize tumors to chemotherapeutic agents through down-regulation of the Multidrug resistance protein and other mechanisms. In addition to its chemo-preventive effects, silymarin exhibits antitumor activity against human tumors in rodents. so we aim to assess the antitumor activity of silymarin in metastatic colorectal cancer patients receiving chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* - Patients with histologically and/or radiologically confirmed diagnosis of metastatic colorectal carcinoma.
* Patients who received FOLFOX or XELOX as first line chemotherapy
* Both genders.
* Age ≥18 years old.
* Performance status 0-1 according to the Eastern Cooperative Oncology Group (ECOG).
* Patients with adequate hematologic parameters (white blood cell count

  ≥3000/mm3, granulocytes ≥1500/mm3, platelets ≥100,000/mm3, hemoglobin ≥ 8 gm/l).
* Patients with adequate renal functions (serum creatinine ≤1.5 mg/dL).
* Patients with adequate hepatic functions (bilirubin ≤1.5 mg/dL or albumin ≥3 g/dL).

Exclusion Criteria:

* - Patients with active liver diseases (chronic viral hepatitis, autoimmune hepatitis, alcoholic hepatitis, Wilson's disease, hemochromatosis, or cirrhosis).
* Patients with a history of other malignancy.
* Patients with brain metastasis.
* Patients with active infection.
* Patients with RAS wild type cancer.
* Patients on chronic use of corticosteroids.
Penetrating Gunshot Injuries at a Single Johannesburg Centre

A retrospective audit of cardiac penetrating cardiac injuries with specific reference to GSW

A descriptive retrospective study looking at the outcomes in patients with penetrating cardiac injuries especially following gunshot injuries. The physiology on presentation, the ISS, the RTS, the clinical injuries confirmed, the type of investigations conducted, the length of hospital stay, the in-hospital mortality will all be collected. Descriptive study statistics will be utilized and a p-value of \<0,05 will be considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* all adult Priority 1 patients with GSW cardiac injuries seen at a Johannesburg Trauma facility

Exclusion Criteria:

* Incomplete data or dead on arrival
Concordance of Inivata Liquid Biopsy With Standard Tissue Biopsy

This study aims to look at a comparison of liquid biopsy (blood sample) analysis compared with tissue biopsy in patients with advanced lung cancer

The primary aim of this study is to investigate the concordance of Inivata liquid biopsy panel with standard tissue biopsy analysis for detecting genomic alterations in patients with advanced non-squamous non-small cell lung cancer (NSCLC).

Eligibility Criteria:
Inclusion Criteria:

* Written, signed and dated informed consent
* Male \& female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous NSCLC.
* Patients intended to initiate first-line treatment (Arms A and B)
* Patients who plan to have or have had a recent tumor tissue biopsy taken as part of their standard of care (Arm A)
* Patient must understand and be able, willing and likely to fully comply with all study procedures and restrictions.

Exclusion Criteria:

* Patients who have received any approved or experimental cancer therapy since their most recent NSCLC tissue biopsy
* Any history of metastatic cancer.
* Previous malignancy in the last 2 years (except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix).
* Patient with a severe acute or chronic medical or psychiatric condition or laboratory abnormality
Safety & Pharmacokinetics Study Of Azacitidine (SC And Oral) In Subjects With MDS, CMML, AML, Lymphoma And Multiple Myeloma

The purpose of this study is to compare the amount of drug that gets into the bloodstream between different tablets taken by mouth and an injection under the skin.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Diagnosis of MDS or CMML
* Diagnosis of AML, Multiple myeloma, Hodgkin's or Non-Hodgkin's lymphoma for whom standard curative or palliative measures do not exist or are no longer effective
* ECOG Performance Status 0-2
* Use of acceptable birth control
* Standard safety inclusion for serum creatinine, AST, ALT, bilirubin
* Serum bicarbonate greater than or equal to 20 mEq/L
* Platelet count greater than or equal to 25,000/uL
* Hemoglobin greater than or equal to 500/uL
* Signed informed consent

Exclusion Criteria:

* Diagnosis of acute promyelocytic leukemia
* Treatment with demethylating agents within 21 days prior to Cycle 1, Day 1
* Treatment with any anticancer therapy (standard or investigational) within 21 days prior to Cycle 1, Day 1 or ongoing adverse events from previous treatment
* Hypersensitivity to azacitidine or mannitol
* Active, uncontrolled infection
* Presence of GI disease, malignant tumors or other conditions known to interfere with ADME
* Known or active HIV, viral hepatitis B or C
* Breastfeeding or pregnant females
* Current or uncontrolled cardiac disease
Study of Vitamin A and Carbomer in Comforting the Ocular Surface Irritations of Glaucoma Patients

Most of the patients under long application of anti-glaucoma eyedrops endure severe ocular surface irritation, which interrupt their quality of life a lot. Lots of studies aimed to search for new drugs for therapy. The investigators hypothesized that the artificial tears containing vitamin A or carbomer may be a great substitute. Both of the two drugs were in common use and had already been tested in animals.


Eligibility Criteria:
Inclusion Criteria:

- diagnosed primary open-angle glaucoma or normal tension glaucoma patients with prostaglandin analogs treatment for more than one year.

Exclusion Criteria:

1. any systemic diseases which may cause ocular damage;
2. previous ocular trauma or surgery;
3. contact lens wear history in previous 6 months;
4. application of any artificial tears 3 months ago;
5. allergic to any of the drugs we used during examination.
STAR*D Alcohol: Treatment of Depression Concurrent With Alcohol Abuse

The purpose of this study is to determine if having an alcohol use disorder affects recovery from depression, and also whether recovery from depression in patients who have alcohol use disorders is also accompanied by improvement in the alcohol use disorder.

This is an extension of the multi-site sub-study of the National Institute of Mental Health (NIMH) protocol, Sequenced Treatment Alternatives to Relieve Depression (STAR\*D), which utilized the infrastructure of the Depression Trials Network to enroll 4,000 subjects diagnosed with Major Depressive Disorder. These subjects initially received 12 weeks of treatment with the anti-depressant citalopram. The thrust of this study was to test treatment algorithms for those subjects who did not respond adequately to initial monotherapy treatment with citalopram or who were unable to tolerate it. The parent protocol also contained several ancillary studies, including a sub-study of subjects with co-morbid alcohol use disorders, which enrolled 130 subjects. Treatment response data was collected at multiple intervals during the 12 week treatment period on depressed subjects both with and without a co-morbid alcohol use disorder.

Comparison: Treatment outcome measures of subjects diagnosed with Major Depressive Disorder will be compared to treatment outcome measures of subjects diagnosed with Major Depressive Disorder and an Alcohol Use Disorder following the initial 12 week citalopram treatment period. This comparison will show whether having a co-morbid alcohol use disorder affects recovery from depression. In addition, alcohol use data of depressed subjects who demonstrated a positive response to anti-depressant treatment will be compared with alcohol use data of depressed subjects who did not have positive treatment outcomes. This comparison will show whether recovery from depression is associated with improvement in the co-morbid alcohol use disorder.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18- 75 years
* Meets criteria for Non-psychotic Major Depression
* Signs informed consent and able to comply with study
* Hamilton Depression Scale (HAM-D 17) \>14
* Endorses any drinking items on Short Michigan Alcoholism Screening Test

Exclusion Criteria:

* Pregnant women and women of childbearing potential who are not using a medically accepted means of contraception.
* Women who are breast feeding
* Patients with suicidal ideation that require hospitalization
* Patients with unstable physical disorders
* Patients with a history of allergy to citalopram or history of non-response to an adequate dose of citalopram in the current episode.
* Patients meeting criteria for the following diagnoses as a primary condition: Schizophrenia, Schizoaffective Disorder, Bipolar I, II, and Not Otherwise Specified, Anorexia nervosa, Bulimia, Obsessive Compulsive Disorder
* Patients abusing substances which require detoxification. American Society for Addiction Medicine standards for detoxification will be used (Level III.7). Patients with substance abuse who are in substance abuse treatment will be eligible.
LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers

To evaluate the persistence of anti-HBs antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.

The primary study was to evaluate the reactogenicity, immunogenicity and protective efficacy of a hepatitis B vaccine in healthy neonates of HBeAg positive mothers if administered with or without a dose of HBIg at birth. The current study describes the long term follow up of these subjects between Y16 and 20 after primary vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who had received at least one dose of the study vaccine in the primary study
* Written informed consent obtained from each subject before each blood sampling visit

Exclusion Criteria:

* None
Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use

The purpose of this study is to determine whether an injection of a local anesthetic (Bupivacaine with epinephrine) in the vaginal cuff prior to closure would result in less immediate postoperative pain medication and increase patient comfort/satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years and older requiring total laparoscopic hysterectomy with or without bilateral salpingo-oophorectomy for benign conditions
* Presence of malignancy

Exclusion Criteria:

* Conversion to laparotomy

  * Previous multiple abdominal and/or pelvic surgeries
  * Significant medical comorbidities or cardiac history
  * Poor initial Aldrete score4 (\<10)
  * Significant pre-op pain medication use
  * Contraindication to any medication that would be used in the study (Bupivacaine, epinephrine, tramadol or oxycodone)
Safety and Immune Response of COVID-19 Vaccination in Overweight People With Excessive BMI

On 11 February 2020, the International Committee for the Classification of Viruses named the disease caused by SAＲS-CoV-2 infection in humans as the new coronavirus pneumonia (coronavirus disease 2019, COVID-19). Due to the changes of immune function and cardiopulmonary function in overweight people, the infection and severity of these patients are higher than that of the general population during the epidemic period. More attention should be paid to personal protection and disease prevention. Vaccination with COVID-19 vaccine can effectively prevent COVID-19 infection, delay or prevent patients from developing into critical illness and reducing mortality. In order to evaluate the safety and efficacy of COVID-19 vaccine for overweight people, and to guide COVID-19 vaccination more scientifically, rationally and effectively, this study was carried out.

Due to the changes of immune function and cardiopulmonary function in overweight people, the infection and severity of these patients are higher than that of the general population during the epidemic period. More attention should be paid to personal protection and disease prevention. Vaccination of COVID-19 can effectively prevent COVID-19 virus infection and delay or prevent patients from developing into critical illness and reduce mortality. The safety and effectiveness of COVID-19 vaccine in this population were evaluated in order to play a scientific and theoretical supporting role in guiding COVID-19 vaccination more scientifically, reasonably and effectively. The samples of this study were collected and tested in the second affiliated Hospital of Chongqing Medical University. Patients with contraindications for vaccination will be excluded. The detected indexes included blood routine test, liver function, COVID-19 antibody titer, antibody duration and other indexes of healthy people (control group) and overweight people after vaccination ( 1, 3, 6 months after vaccination). The adverse reactions related to the vaccine were recorded.

Eligibility Criteria:
Inclusion Criteria:

- 1.Healthy group were as follows: no history of hepatitis, no history of liver cirrhosis, no history of liver cancer and receiving the whole-course COVID-19 vaccination.

2. Overweight people are defined as having a BMI of more than 24 and receiving the whole-course COVID-19 vaccination.

Exclusion Criteria:

* Patients previously diagnosed or with a history of contact with confirmed cases
Observatory of Patients With MyeloProliferative Neoplasm Treated With Anti-inflammatory Immunotherapy

The study will collect cases of MPN patients who also benefit from an anti-inflammatory immunotherapy for another disease. Efficacy and tolerability of the drug will be assessed in this population.


Eligibility Criteria:
Inclusion Criteria:

* MyeloProliferative Neoplasm diagnosis
* receiving or having received an immunotherapy targeting IL-1, IL-6, IL-17, IL-23 or TNF

Exclusion Criteria:

* Unable to consent