cyrilzakka/clinical-trials huggingface dataset:
SMS HPV Vaccine Reminders

This study will take place at health centres and their affiliated schools and community immunization centers overseen by the Kampala Capital City Authority (KCCA) as well as at the Makerere/Mulago/Columbia Adolescent Health Clinic, also in Kampala. While text messages can be used in populations with low literacy, families can opt to receive automated phone call reminders instead. The investigators will pilot assess the impact of vaccine reminders on human papillomavirus (HPV) vaccination. Caregivers of preteens/adolescents will be randomized and stratified by site, language and HPV vaccine dose needed (initiation vs. completion). As this is a feasibility trial, the investigators expect to measure effect size but not necessarily achieve statistical significance.

Cervical cancer is the leading female cancer in Uganda. Many women are diagnosed with late-stage disease, and 80% of women die within 5 years of diagnosis, making primary prevention critical. HPV is the principal cause of cervical cancer, making vaccination the single most important primary preventive measure. The national HPV vaccination program in Uganda began in November 2015 and focuses solely on preteen/adolescent girls. Two strategies have been adopted for the multi-dose series: 1) school-based and 2) community-based. However, in Kampala, only 29% of girls receive both needed doses. Reasons for undervaccination include school absenteeism on special vaccination days for those receiving vaccination as part of a school program, failing to remember to come to a health facility for a needed dose for those being vaccinated in the community, and lack of knowledge regarding HPV and the vaccines including vaccine misperceptions. While research regarding the use of text message vaccine reminders is strong in the U.S., their use has not yet been demonstrated in a preteen/adolescent population in Sub-Saharan Africa and other low and middle income countries (LMICs). According to the World Bank, currently 89.9% of urban households in Uganda have a cell phone.

Eligibility Criteria:
Inclusion Criteria:

* Be a parenting adult of an adolescent girl aged 10-14 years
* Reside in Kampala and/or the surrounding districts
* Speak English or Luganda
* Have a cell phone with text messaging capability
* Must have ability to consent

Exclusion Criteria:

* Parenting adult speaks other language than English or Luganda only
* Parenting adult already enrolled in the study for another child
* Participation in pretesting activities
On the Impact of Therapeutic Tumor Necrosis Factor-alpha Inhibition on Anogenital Human Papillomavirus Infection

In this prospective, open, controlled, cross-sectional observational study patients with psoriasis or IBD, who received either anti-TNF-alpha inhibitors or alternates (purine-, folic acid analogues, phototherapy, fumaric ester, mesalazine) for their underlying disease were included.

Anogenital HPV-induced lesions, mucosal HPV DNA and serological status of mucosal low-risk (HPV6) and high-risk HPV (HPV16, HPV18) were determined.

In this prospective, open, controlled, cross-sectional observational study patients with psoriasis or inflammatory bowel diseases (IBD), who received either Tumor necrosis factor-alpha (TNF-Alpha) inhibitors or alternates (purine-, folic acid analogues, phototherapy, fumaric ester, mesalazine) for their underlying disease were included.

Patients were assigned to the following subgroups according to their current therapy for ≥ 6 months: i) TNF-alpha inhibitor monotherapy; ii) monotherapy with purine or folic acid analogues, such as azathioprin, 6-mercaptopurine, or methotrexate iii) combination therapy with TNF-alpha blocker plus purine or folic acid analogues; iv) alternate therapy, such as phototherapy, fumaric acid, mesalazine. The last group additionally included patients that were without any therapy.

Information about duration and severity of illness, current and former disease-related medical treatment, smoking habits and sexual history with emphasis on preexisting human papillomavirus (HPV) infection, including anogenital warts or previous abnormal cervical cytology, and HPV vaccination status were obtained for each patient.

Swab samples were taken at one time point from the penile shaft and glans of men, the vulva and cervix in women, and the perianal region of both genders.

Detection of mucosal human papillomavirus DNA in the samples was performed using the FDA-approved Digene Hybrid Capture 2 kit.

Cervical Papanicolaou (PAP) smears were collected by cytobrush from female patients at the same time.

Blood for determination of serological status was drawn from each patient and peripheral blood mononuclear cells and serum obtained.

Eligibility Criteria:
Inclusion Criteria:

* Participants between 18-80 years of age with a history of psoriasis or inflammatory bowel diseases, namely Crohn's disease and ulcerative colitis, and
* at least 6 month of continuous treatment regimen.

Exclusion Criteria:

* Pregnant or nursing patients and
* patients with inherited immune disorders, human immunodeficiency virus infection, invasive malignancies or psychomotor retardation and
* patients with psoriasis or inflammatory bowel diseases who had received high-dose corticosteroids during the past 6 months.
FreeDom: Innovative Strategy for the Management of COPD Exacerbations

The main objective of the study is to assess the "FreeDom" innovative strategy (FreeO2 at Domicile) to reduce hospitalization duration in patients with COPD exacerbation. This strategy associates early hospital discharge, automated O2 flow weaning with FreeO2 system, telemedicine and tele-rehabilitation.

The main hypothesis of this study is that the FreeDom strategy will reduce the number of hospitalization day by 50 percent at day 30.

The main objective of the study is to assess the "FreeDom" innovative strategy (FreeO2 at Domicile) to reduce hospitalization duration in patients with COPD exacerbation. This strategy will enable an early return home, patients using an innovative device that automatically adjusts and wean the oxygen flow (FreeO2 system) coupled to telemedicine and tele-rehabilitation.

The main hypothesis of this study is that a strategy for an early return home with a home hospitalization managed by telemedicine will reduce the length of hospitalization by 50 percent from 30 days.

Eligibility Criteria:
Inclusion Criteria:

All patients hospitalized for COPD exacerbation for less than 48 hours will be considered.

* known or suspected COPD to entry
* Age \> or = 40 years
* Ex-smoker history (10 pack / year or more)
* Acute Exacerbation: dyspnea of recent onset (less than 15 days)
* The need for oxygen therapy with a moderate rate: \<6L / min to maintain SpO2 \> 90% (for oxygen dependent patient, the oxygen flow must be higher than flow at home)

Exclusion Criteria:

* Refusal to consent to participate in the study,
* Indication for an imminent intubation according to the pulmonologist,
* Sleep Apnea
* NIV used at home
* Lack of FreeO2 system available at the time of randomization
* Non-autonomous and alone at home
* Patient alone at home
* Patients who live more than 50 km from the hospital
* Patient already included in the study within 3 months
Study of Oral Upadacitinib to Assess Change in Disease Activity in Adult Participants With Ulcerative Colitis

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).This study will assess how effective upadacitinib is in treating UC.

Upadacitinib (RINVOQ) is an approved drug for treating UC. Approximately 400 adult participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in Germany, Austria and Switzerland.

Upadacitinib will be administered in accordance with the terms of the local marketing authorization, and treatment of participants will be determined solely by the investigator. Participants in the study will be followed for up to 2 years.

There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and only data which are routinely collected during a regular visit will be utilized for this study.


Eligibility Criteria:
Inclusion Criteria:

* Participants with an endoscopically confirmed diagnosis of active moderate to severe Ulcerative colitis (UC).
* Participants initiating Upadacitinib (UPA) at the investigator's discretion as part of their routine clinical care; the decision to administer UPA must be made prior to and independent of documentation for the study and according to the approved local label.
* Participants able to understand and communicate with the investigator and comply with the requirements of the study.
* Participants willing to continue with study documentation after cessation of UPA.

Exclusion Criteria:

* Participants with any contraindication to Upadacitinib (UPA).
* Participants previously exposed to a Janus kinase (JAK) inhibitor.
Pharmacological Intervention in Depression After Traumatic Brain Injury

The purpose of this study is to determine if treatment with venlafaxine reduces symptoms of depression in persons with traumatic brain injury.

The study evaluates the benefits of a promising antidepressant medication for the treatment of persons with traumatic brain injury (TBI) and major depressive disorder (MDD). The study is a randomized, double-blind, placebo-controlled trial of venlafaxine (a serotonin and norepinephrine reuptake inhibitor, also known as Effexor). Venlafaxine has been well established in the treatment of MDD in healthy individuals and is a recommended depression treatment agent for persons with TBI. By using a rigorous scientific methodology, this study will be an important first step in advancing the treatment of depression in this population beyond general impressions to proven treatments.

Eligibility Criteria:
Inclusion Criteria:

* Must have a documented traumatic brain injury (TBI), defined as damage to brain tissue caused by an external mechanical force as evidenced by: loss of consciousness due to brain trauma, or post traumatic amnesia (PTA), or skull fracture, or objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination.
* Age 18 years or older
* At least three months postinjury
* Presence of major depressive disorder (MDD), as defined by Structured Clinical Interview for DSM-IV (SCID) interview
* Hamilton Depression Rating Scale (Ham-D) scores of 18 or greater on two consecutive evaluations (screening and baseline)

Exclusion Criteria:

* Individuals under 18 years of age
* Pregnancy, as determined by urine pregnancy screen
* Prisoners
* Individuals who are institutionalized
* Individuals who are not cognitively capable of completing the SCID interview and the Ham-D
* Unstable medical condition, defined as any significant medical condition likely to require hospitalization during the study period, or requiring adjustment in medications in the past month
* Active suicidality
* Severe depression that, in the investigator's professional opinion, will likely require hospitalization during the study time period
* Diagnosis of bipolar disorder, as defined by SCID interview
* Diagnosis of schizophrenia or other psychotic disorder, as defined by SCID interview, other than major depression with psychotic features
* Active drug or alcohol abuse within the past 3 months, as defined by SCID interview
* Dysphagia sufficient to preclude use of oral medications
* Known hypersensitivity to venlafaxine
* Use of monamine oxidase inhibitors (MAOI) within the past month
* Treatment with antidepressant medication within the past 3 months
* Concomitant administration of medications that interact with venlafaxine to a clinically significant degree
Structured Online Contraceptive Counseling (LOWE Trial) At Emergency Contraception (EC) Pharmacy Provision LOWE+EC=LOWEC

To increase sexual and reproductive health and rights through the improvement of contraceptive counseling and easy access to service and, thus, women's use of effective contraceptives after purchase of an emergency contraceptive pill (ECP).

This pragmatic cluster randomised cross-over controlled trial aims to determine whether the composite intervention of online contraceptive counseling at the time of a pharmacy provision of emergency contraceptive pill (ECP), plus an invitation to a sexual and reproductive health clinic, will result in increased use of subsequent effective contraception (hormonal or intrauterine) compared with standard care.

The study will be conducted at approximately 30 pharmacies in the Stockholm Region. Clients who will buy an ECP (without prescription) at one of these pharmacies will be invited by posters and pharmacy personnel to participate in the study. By scanning a quick response (QR) code they will receive more information about the study. Eligible women who choose to participate in the study and give their consent will be allocated to intervention or control group depending on the visited pharmacy's allocation.

Participants at the intervention pharmacies will receive an intervention package with online structured contraceptive counseling followed by an online invitation to a clinic for contraceptive provision. While participants at the control pharmacies will purchase the ECP without any further guidance. The order in which the pharmacies will provide the intervention or control will be randomly assigned at a ratio 1:1 by an independent statistician. The recruitment will halter for an intervening period of at least two weeks when the pharmacies switch to the new group depending on their first allocation (cross-over).

An online baseline questionnaire and follow-up questionnaires will be collected at 1 and 12 months following the ECP provision for participants both from intervention and control pharmacies.

The randomized controlled trial will be conducted together with a process evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Women \>/=15 years visiting a pharmacy to buy ECP for her own use
* Has a smartphone with an electronic identification and ability to scan a QR code
* Ability to read Swedish or English
* Willing and able to provide informed consent
* Willing to participate in the follow-up

Exclusion Criteria:

\* Ongoing pregnancy
Urban African-American Community Hypertension Control

To investigate whether a health education program, developed in partnership with the community and delivered by nurse supervised community health workers (CHWs), lowered high blood pressure (HBP) in inner city African American adults.

BACKGROUND:

This population based study was significant because it offered a multidisciplinary, community HBP control program to help close the gap in health status for African Americans. The study was conducted in response to a demonstration and education initiative, "Improving Hypertensive Care for Inner City Minorities", which was reviewed and approved by the Clinical Applications and Prevention Advisory Committee in April 1992 and by the National Heart, Lung, and Blood Advisory Council in May 1992. The Request for Applications was released in October 1992.

DESIGN NARRATIVE:

The two and a half year intervention trial sought to extend and test the generalizability of prior work in a similar inner city African American community, which demonstrated the efficacy of planned health education programs that were culturally-sensitive, community-based and owned, and built upon appropriate behavioral and community activation theory and principles, in improving the control of HBP and decreasing related morbidity and mortality.

Five hundred men and 500 women were recruited from households in neighborhood blocks randomly assigned to a more or less intensive educational-behavioral intervention. Both groups received usual medical care, community HBP education, and HBP patient education materials. In addition, the more intensive group received 1) individualized educational counseling sessions with the CHW to increase understanding of HBP and to address barriers to control of HBP; 2) outreach and follow-up to address inadequate health care resources and health behavior related skills through interim monitoring and education "booster" sessions; and 3) mobilization of social support from a family member/friend identified by the participant as the primary source of daily reinforcement.

Statistical analysis focused on BP change in all adults with HBP on randomized blocks whether or not they participated in either of the intervention groups (program effectiveness), as well as BP change in all adults participating in the two interventions regardless of their level of compliance (intervention efficacy). In addition, the analysis focused on differences in the two groups regarding individuals' adherence to HBP lowering recommendations to enter/re-enter care, remain in care, modify lifestyle, and take HBP medication. Multiple regression was done to determine the contribution of the changes in the major independent variables (perceived barriers, use of health care resources and health care skills, and social support) to changes in the outcome and intervening variables which included adherence to HBP lowering recommendations.

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
Study of S-1 Plus LV for Untreated Metastatic Colorectal Cancer

This is a multicenter study designed to evaluate the response rate of S-1 plus Leucovorin (1 week on and 1 week off) as first -line treatment for patients with metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proved adenocarcinoma
* Unresectable and recurrent colorectal cancer
* Age20 ≤ at enrollment
* Performance status 0 or 1 (ECOG)
* No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 containing treatment shall be excluded
* Adequate hematologic, hepatic and renal functions
* At least one measurable lesion by RECIST criteria

Exclusion Criteria:

* Serious drug hypersensitivity
* Pregnant or nursing
* Bleeding from gastrointestinal tract
* Diarrhea
* Simultaneously active double cancer
* Serious illness or medical condition
* Brain metastasis
Quantification of Cannabinoids and Comparison to Post-Surgical Pain Medication Requirements and Surgical Outcomes

To determine how daily cannabis use affects surgical outcomes.

To determine if patients who are daily cannabis users that are undergoing inpatient abdominal surgery for the treatment of cancer are different from non-cannabis users regarding phytocannabinoid and endocannabinoid levels, pain scores, pain medication requirements, and surgical complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old
* Undergoing abdominal surgery for the treatment of cancer
* Report no cannabis use in the last year or chronic cannabis use (defined as at least weekly use for 3 months or more)

Exclusion Criteria:

* patients with chronic pain, chronic pain syndrome on opioids
* female patients who are pregnant or lactating
* patients who report use of illicit substances
Genetic Counseling and Lifestyle Change for Diabetes Prevention

This study will examine the impact diabetes genetic counseling on patient motivation and disease prevention behaviors among subjects with pre-diabetes. Intervention subjects will be provided with their individual diabetes genotype risk score derived from aggregating the combined results of 37 diabetes risk-associated genetic loci. Controls will not be tested. All subjects will be enrolled in a 12-week diabetes prevention program.

This study will examine the impact diabetes genetic counseling on patient motivation and disease prevention behaviors among subjects with pre-diabetes. We will randomize subjects with pre-diabetes to genetic testing vs. no genetic testing in order to obtain an unconfounded test of the hypothesis that genetic testing will change patient behavior. Intervention subjects will be provided with their individual diabetes genotype risk score derived from aggregating the combined results of 37 diabetes risk-associated genetic loci. Because patients can receive either "Higher risk" or "Lower risk" genetic test results, we will separately examine the impact of "Higher risk" and "Lower risk" test results compared to untested controls. All subjects will be enrolled in a 12-week diabetes prevention program.

Eligibility Criteria:
Inclusion Criteria:

* Overweight (Body mass index ≥ 29.1 kg/m2 in men, ≥ 27.2 kg/m2 in women) with at least 2 other formal criteria for Metabolic Syndrome (see Table -NCEP ATP-III Criteria)
* Adult (\> 21 years of age)
* No diagnosis or treatment for diabetes (Type 1 or Type 2) or cardiovascular disease (e.g. myocardial infraction, coronary bypass surgery, congestive heart failure, peripheral vascular disease)
* Physically able and willing to participate in a 12-week group session curriculum for weight loss and dietary change
* Able to understand and communicate effectively in English
Tap Block and Cesarean Delivery: Efficacy and Consumption of Postoperative Drugs

The purpose of this study is to determine the efficacy of Tap block after cesarean delivery as a component of multimodal analgesia and evaluation of postoperative drugs consumption.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* written consent
* anesthesiologist's assent on preoperative evaluation

Exclusion Criteria:

* age\< 18 years
* uncooperative patients
* written consent not obtained
* local anesthetic allergy
* BMI \> 35