cyrilzakka/clinical-trials huggingface dataset:
Behavioral Intervention to Enhance HIV Test/Treat

Prevention strategies that aim to test and treat people for HIV infection are undermined by HIV treatment non-adherence and sexually transmitted co-infections (STI). The proposed study will test a theory-based behavioral intervention to reduce HIV infectiousness by simultaneously improving HIV treatment adherence and reducing sexually transmitted co-infections in people living with HIV-AIDS who use alcohol and other drugs. The intervention is delivered in a single office-based counseling session followed by 4 cell phone delivered counseling sessions in a model that will be ready for immediate dissemination to case management and clinical services for people living with HIV/AIDS in resource constrained settings.

Prevention strategies that aim to test and treat people for HIV infection are undermined by HIV treatment non-adherence and sexually transmitted co-infections (STI). Scalable interventions are urgently needed to sustain low infectiousness by improving HIV treatment adherence and reducing risks for transmitting HIV. This application proposes to test a theory-based behavioral intervention to simultaneously improve HIV treatment adherence and reduce HIV transmission risk behaviors in people living with HIV/AIDS who use alcohol and other drugs. Grounded in Conflict Theory of Decision Making, the intervention will be delivered in a mixed format, with one office-based counseling session followed by four cell phone delivered counseling sessions. The intervention will be conducted in Atlanta and surrounding impoverished areas. Men (n = 250) and women (n = 250) receiving HIV treatment will be recruited from AIDS services and infectious disease clinics. Following informed consent and baseline assessments, participants will be randomly assigned to either an (a) integrated HIV treatment adherence - risk reduction intervention or (b) a time-matched non-contaminating attention control condition. Participants will be followed for 12-months using office-based computerized interviews, unannounced pill counts, and medical chart abstraction. The study will test the hypothesis that a unified, integrated theory-based HIV treatment and risk reduction intervention will reduce HIV transmission risk behaviors, improve HIV treatment adherence, reduce viral load and prevent new STI. The study will also examine the influence of theoretical constructs and structural barriers on intervention outcomes. Factors that predict relapse to non-adherence and risk behaviors in relation to changes in viral load and STI over the 12-month follow-up period will also be a focal point of the study. The intervention under investigation will be among the first to simultaneously address treatment adherence and risk behavior in an integrated model for substance using HIV positive men and women. If shown effective, the intervention model will be ready for immediate dissemination to community and clinical services for people living with HIV/AIDS.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* HIV positive
* Sexually active in the previous Month
* Active substance use

Exclusion Criteria:

* None
A Study of Rofecoxib Versus Naproxen in the Treatment of Chinese Patient With Rheumatoid Arthritis (0966-231)

A study to compare rofecoxib versus naproxen in the treatment of Chinese patients with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Chinese males or females at least 18 years of age with rheumatoid arthritis
Pancreaticogastrostomy for High-Risk Pancreas

In 2013, a double purse-string telescoped pancreaticogastrostomy (PG) technique appeared to significantly reduce the risk of postoperative pancreatic fistula (POPF). This study compared the incidence of clinically relevant POPF in patients with high-risk anastomosis after undergoing PG or pancreaticojejunostomy (PJ) techniques.

From 2013 to 2019, consecutive patients with high-risk anastomosis (i.e., updated alternative-Fistula Risk Score (ua-FRS) \>20%) underwent pancreatoduodenectomy with either the PJ or PG technique. Optimal mitigation strategy (external stenting and octreotide omission) was applied for all patients. The primary endpoint of the study was the incidence of clinically relevant POPF. Data were entered prospectively into an institutional clinical database (NCT02871336).

Eligibility Criteria:
Inclusion Criteria:

* Pancreatoduodenectomy
* High updated alternative -Fistula Risk Score which was defined \> 20%, as the higher-risk category of the alternative-Fistula Risk Score

Exclusion Criteria:

* Explorative laparotomy
* Hard pancreatic parenchyma
Study of Pregabalin Therapy for Pain Relief in Subjects With Post-Herpetic Neuralgia

The purpose of this study is to measure how rapidly pregabalin treatment can relieve pain in patients with post-herpetic neuralgia


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PHN with pain present for at least three months after the healing of a Herpes Zoster skin lesion.
* Subjects must have completed the Daily Pain Rating Scale in the electronic diary at least 4 times during screening and have an average daily pain rating score of greater than or equl to 4 during the 7 +/- 3 days prior to randomization (Visit 2).

Exclusion Criteria:

* History of neurolytic or neurosurgical therapy for PHN.
* Presence of any severe pain associated with conditions other than PHN that may confound the assessment or self-evaluation of the pain due to PHN.
iT-based Sports Therapy Application in Haemophilia

Haemophilia is often associated with chronic pain, functional restrictions and negative consequences regarding the individual physical performance, especially on basic motoric skills, activities of daily life and quality of life. Caused by high benefits, physical activity is a fixed component and recommendation in the guidelines for the management of haemophilia. Several studies showed that goal-directed physical activity is feasible for patients with haemophilia (PwH) without any complications or bleeding episodes. Nevertheless, there are difficulties in the implementation of supervised sports therapy for PwH regarding local distributions and uncertainties concerning correct exercise execution on patients´ side and in the monitoring and adequate training regulation from long distances on the therapeutic side.

Aim of this project is a patient-related and participative development and pre-evaluation of a mobile application to generate an online-guided, individualized home training for PwH, followed by pre-evaluation in terms of a twelve weeks interventional phase. The intention of this project is to show, that a mobile device is an appropriate way to increase physical activity of PwH. Due to the development of an innovative trainings application, adapted to the needs of PwH, a larger number of patients should be reached and supported later on in participating on supervised physical exercise to improve the individual physical performance and therefore the quality of life. Additionally, with an individualized exercise program also adapted to the specific interests, needs and physical conditions, PwH at any age can be addressed. Furthermore, in cooperation with the patient, the medical staff will get systematic information of patients´ exercise activities to generate optimal factor and overall treatment patterns. In addition, on the basis of the mobile device PwH will be able to comprehend their individual exercise performance and to get an overview of the individual trainings progress and improvements of physical performance with the purpose to enhance the processes of self-motivation. Detailed instructions and information of exercise execution, need of exercise and physical adaptions to be achieved, will minimize complications and support patients´ self-confident for participating on exercise.


Eligibility Criteria:
Inclusion Criteria:

* patients suffering from moderate to severe haemophilia A or B
* submitted written consent to participate in the study
* approved sports capability and internet access

Exclusion Criteria:

* patients suffering from other bleeding disorders
* patients without written consent
* patients under 18 years of age
* patients without sports capability
* patients without internet access
Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection

Randomized open label clinical trial to compare the clinical and microbiological efficacy of fecal microbiota transplantation, fidaxomicin, and vancomycin for relapsing Clostridium difficile infection


Eligibility Criteria:
Inclusion Criteria:

1. Relapse of Clostridium difficile infection with previous trial of vancomycin or fidaxomicin

Exclusion Criteria:

1. Pregnancy or breastfeeding
2. Does not speak or understand the Danish language
3. Current antibiotic treatment other than metronidazole, vancomycin, fidaxomicin
4. fulminant colitis which contraindicates medical treatment
5. physician's evaluation that the patient cannot tolerate project inclusion
Uterine Artery Ligation to Decrease Blood Loss With Central Placenta Previa

This trial will address the effect of uterine artery ligation during Cesarean section in cases with placenta previa to decrease blood loss.

This Study will address the effect of uterine artery ligation prior to fetal delivery during Cesarean section in cases with central placenta previa to guard against postpartum hemorrhage and to minimize blood loss.

Eligibility Criteria:
Inclusion Criteria:

* Placenta previa is diagnosed when the lowest placental edge is located within 5 cm of the internal os at ultrasound
* Symptomatic Placenta previa with at least one episode of bleeding
* Estimated gestational age within 28 to 40 weeks
* Maternal age \> 18 years
* Informed consent
* Social affiliation

Exclusion Criteria:

* Premature rupture of membranes
* Severe bleeding.
* Abnormal fetal heart rates.
* Pre-eclampsia, chorioamnionitis, severe chronic renal disease.
Sleep Apnea and Obesity Affects on Morphine Pharmacokinetics

Adenotonsillectomy (AT) is one of the most common pediatric surgeries performed, and is estimated to comprise 530,000 procedures in children under 15 years of age. Historically, the leading cause for these procedures was recurrent infections; however, more recently surgical indications include sleep disordered breathing and obstructive sleep apnea (OSAS). Pre-operative polysomnography (PSG) is recommended for all children with suspected OSAS prior to undergoing AT, although it is unclear whether sleep disordered breathing characteristics predict post-operative outcomes or complications.

Obesity has become an epidemic in the pediatric population. More recently, an increased population of obese children are presenting for AT with upper airway obstruction with or without tonsillar hypertrophy, which is similar to the adult etiology of OSAS. Obesity is a multisystem disease, causing fatty liver and cardiac disease, defects in glucose metabolism, insulin resistance, leptin resistance, and creates a state of chronic inflammation. Markers for inflammation, including tumor necrosis factor (TNF)-α, C-reactive protein (CRP), leptin, interleukin (IL)-6 and IL-10, are abnormal in obese patients and have also been linked to more severe OSAS disease in children even after controlling for BMI.

In pediatrics, medication dosing is based on an actual body-weight calculation, however, recent reports suggest that this dosing method is over-dosing patients with obesity. Therefore, increased respiratory complications after surgery may be related to inappropriate intra-operative opioid dosing.

Specific Aim 1 (SA1): To compare morphine pharmacokinetics in normal children \<=12 years of age, non-obese children with severe OSAS, and obese children with severe OSAS. The investigators hypothesize that obesity independently enhances morphine pharmacokinetics.

Specific Aim 2 (SA2): To determine whether biomarkers related to obesity, chronic inflammation, and OSAS predict changes to morphine pharmacokinetics. The investigators hypothesize that inflammatory and obesity-related biomarkers are elevated in overweight children with OSAS, more so in obese children with OSA, compared to lean children with OSAS. In addition, the investigators hypothesizes that leptin independently is linked to altered morphine pharmacokinetics.


Eligibility Criteria:
Inclusion Criteria:

* Child presenting for surgery that will require opioids
* Age between 5 -12 years of age

OSAS group:

* Pre-operative polysomnography study conducted prior to day of surgery

Obese:

* Body weight \>95th percentile for age.

Exclusion Criteria:

* Emergency procedures involving AT, including tonsillar bleeding
* Patients allergic to morphine
* Patients with comorbidities altering opioid metabolism (i.e. liver disease)
* Patients with chronic inflammatory, rheumatologic, or other confounding co-morbid diseases (i.e. Crohns disease, ulcerative colitis, sickle cell, Sjogren's, etc.)
Study of Endothelial Keratoplasty Outcomes

Endothelial keratoplasty is a cornea-sparing transplant technique that replaces only the diseased endothelial cell layer of the patient's cornea. This technique offers many advantages compared with traditional full-thickness cornea transplants. Patients experience minimal change in glasses prescription and usually recover useful vision within weeks. Visual fluctuations are minimal during the healing process. The patient's cornea remains structurally intact and is more resistant to injury.

Endothelial keratoplasty is undergoing rapid and widespread adoption. Between 2005 and 2007, the number of corneas placed by US eye banks for endothelial keratoplasty increased ten-fold (2007 Eye Bank Association of America Annual Report). However, the procedure is less than 10 years old, and little is known about long term outcomes. Endothelial keratoplasty candidates at our center are invited to participate in an open enrollment, prospective study of the long-term outcomes of this procedure.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 or older
* Scheduled to undergo endothelial keratoplasty
* Able to provide written informed consent.

Exclusion Criteria:

* Age less than 18 years
An Observational Study of Avastin (Bevacizumab) and Interferon Alpha 2a in Patients With Metastatic Renal Cell Cancer (VERA)

This prospective observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in combination with interferon alpha 2a in patients with previously untreated metastatic renal cell cancer. Data will be collected from each patient for up to 4 years.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically confirmed metastatic renal cell cancer, clear cell type
* Eligible for treatment with Avastin and interferon alpha 2a according to local prescribing information

Exclusion Criteria:

* Contraindications for Avastin or interferon alpha 2a treatment according to local Summary of Product Characteristics
* Known hypersensitivity to Avastin and/or interferon alpha 2a or any of its excipients
Neurofeedback Improves Cognitive Performance and EEG Activity in Elderly With Mild Cognitive Impairment

This is a non-pharmacological pilot study showing the improvement of a SMR/theta neurofeedback training program on cognitive performance and EEG activity in Elderly with Mild Cognitive Impairment.

Neurofeedback training (NF) as self-regulation method of brain activity, may be beneficial in elderly with mild cognitive impairment. In this pilot study, the investigators studied whether a sensorimotor(SMR)/theta NF training could improve cognitive performance and brain electrical activity in a sample group of elderly patients with mild cognitive impairment. Twenty participants performed an electroencephalography recording, a battery of neuropsychological tests before the neurofeedback training program (T0), following the neurofeedback training program (T1) and 1-month follow-up (T2).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Mild Cognitive Impairment
* education level of 9 years of studies minimum
* righthandedness
* subjective memory complaint confirmed by an informant
* a Mini Mental Status Examination score \>20.
* preserve activity of daily living and absence of dementia.

Exclusion Criteria:

* elderly persons who were under guardianship
* resident in nursing facilities
* neurological disease, psychiatric disease
* and involved in another cogniitve intervention.
Outcomes After Esophagectomy With a Focus on Minimally Invasive Esophagectomy and Quality of Life

To assess short and long term outcomes after minimally invasive esophagectomy compared to open esophagectomy. To compare both standard outcome measures as well as patient derived outcome measures, in particular, quality of life (QOL). To look at the applicability of this QOL instrument to this patient group.

Assess short and long term outcomes after minimally invasive esophagectomy(MIE) compared to open esophagectomy. Measure standard observer derived outcomes such as morbidity, mortality, tumor recurrence and also patient derived outcomes, in particular quality of life (QOL) using the MOS SF36 questionnaire. Evaluate whether the SF36 will accurately reflect pre and postoperative changes in clinical status in this patient group.Compare the results of this global QOL instrument (SF 36) to disease specific scales of dysphagia and reflux. Assess the impact of adjuvant or neoadjuvant therapy on QOL in this patient group and determine if any advantages of MIE can be demonstrated.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for MIE (Minimally Invasive Esophagectomy)
* Patients scheduled for open esophagectomy
* Signed informed consent

Exclusion Criteria:

* Patients who are unable to comprehend or complete the QOL instruments.
* Patients less than 18 years of age.
MicroCutter Assisted Thoracic Surgery Hemostasis Registry

The primary purpose of this prospective, open-label, multi-center observational registry with all-comers enrollment is to report on the use of the MicroCutter Stapler in a real world setting in thoracic surgical procedures. Procedures may be open or video assisted thoracic surgery (VATS) including robotic surgical cases. Clinicians will provide objective and subjective evaluation of the use of the stapler in their procedures.

The MATCH registry is a prospective, open label, multi-center observational registry with enrollment of patients requiring surgical stapling during a lobectomy or segmentectomy. Patients will be treated per the clinicians standard of care with medical history and demographic data collected pre-procedure, operative data including clinician's objective and subjective evaluation of the stapler and confirmation of any complications via query and data collection at hospital discharge and each clinician's standard post-operative contact.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing lobectomy/segmentectomy in which the MicroCutter Stapler and Reloads were used.
* Patient is willing and able to sign informed consent form to participate in registry, allowing for collection of data.

Exclusion Criteria:

* Clinician determines no vessels are suitable for the on label use of the MicroCutter Stapler and Reloads.
A Study of an Investigational mRNA-1273.815 COVID-19 Vaccine in Previously Vaccinated Adults

To evaluate immune responses of an Investigational mRNA-1273.815 vaccine against the Omicron subvariant strain (XBB.1.5) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).


Eligibility Criteria:
Inclusion Criteria:

* Participants of childbearing potential may be enrolled in the study if the participant fulfills all of the following criteria:

  1. Has a negative pregnancy test on the day of injection prior to vaccine dose being administered (Day 1).
  2. Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1.
  3. Has agreed to continue using an effective contraception through 2 weeks following injection.
  4. Is not currently breastfeeding.

Exclusion Criteria:

* Has known history of SARS-CoV-2 infection within 3 months prior to enrollment.
* Currently has symptomatic acute or unstable chronic disease requiring medical or surgical care, to include significant change in therapy or hospitalization for worsening disease, at the discretion of the Investigator.
* Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment.
* Reported history of congenital or acquired immunodeficiency (for example, human immunodeficiency virus), immunosuppressive condition, asplenia, or recurrent severe infections disease.
* Has known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients.
* Receipt of the following:

  1. COVID-19 vaccine within 3 months prior to enrollment
  2. Any other licensed vaccine within 28 days before or 2 weeks after the study injection, with the exception of influenza vaccines, which may be given 14 days before or after receipt of a study vaccine.
  3. Systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to Screening (for corticosteroids ≥10 milligrams/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. Note: Inhaled, nasal, and topical steroids are allowed.
  4. Systemic immunoglobulins or blood products within 3 months prior to Screening or plans for receipt during the study.
* Has donated ≥450 milliliters of blood products within 28 days prior to Screening or plans to donate blood products during the study.
* Has participated in an interventional clinical study within 28 days prior to Screening or plans to participate in an interventional clinical trial of an investigational vaccine or drug while participating in this study.

Note: Other inclusion and exclusion criteria may apply.
Oral Mucositis in Patients Undergoing Antineoplastic Chemotherapy

The purpose of this study was to:

1. To investigate the feasibility of using infrared (IR) thermometer to grade the severity of oral mucositis in patients with multiple myeloma undergoing chemotherapy.
2. To obtain preliminary data on the most optimal method of scoring the severity of oral mucositis by comparing the results obtained using the IR thermometer to the World Health Organization (WHO) mucositis grading system and the patient self-assessment questionnaire.
3. To Investigate the correlation between the quantitative readings obtained from oral mucosa with the IR thermometer.

Several grading systems for oral mucositis are available including those of the World Health Organization (WHO), Radiation Therapy Oncology Group (RTOG), Western Consortium for Cancer Nursing Research WCCNR, and the National Cancer Institute Common Toxicity Criteria (NCICTC) and others However, all of these oral mucositis grading systems rely on visual examination and are therefore subjective and operator-dependent tools and suffer from significant interpersonal variability (6). With the current improvements in medicine and technology, there is definitely a need for a more objective, easy to perform, non-invasive, affordable, quantitative and reproducible tool that is operator-independent to assess the severity of oral mucositis. The introduction of such a tool would greatly improve our ability to compare the oral mucosal toxicity of antineoplastic therapies and the efficacy of various mucoprotective therapies. Furthermore, the use of such a tool can be extended to patients undergoing radiation treatment with or without chemotherapy for various malignancies including head and neck cancers.

Eligibility Criteria:
Inclusion Criteria:

* Multiple Myeloma receiving chemotherapy Grade 3/4 Mucositis

Exclusion Criteria:

* Women of child bearing potential who are unable to take adequate contraceptive precautions, have + pregnancy test w/in 24 hrs prior to study, pregnant, currently breastfeeding will not be able to participate in the study