cyrilzakka/clinical-trials huggingface dataset:
Genotypic Tropism Testing In Proviral Dna To Guide CCR5 Antagonist Treatment In Subjects With Undetectable HIV-1 Viremia

CCR5 antagonists might be an adequate alternative for HIV-1-infected individuals with suppressed viremia who experience antiretroviral-related toxicity. The assessment of HIV-1 tropism in proviral DNA could be helpful to inform in which of these subjects CCR5 antagonists could be efficacious.

The assessment of HIV-1 tropism is needed before starting treatment with a CCR5-antagonist. Several phenotypic and genotyping tropism tests have been developed in the recent years. Phenotypic assays (i.e. TrofileTM and ES-TrofileTM) have been used.in most clinical trials. Genotypic tropism testing, however, is easier, cheaper and faster than phenotypic methods, and can be performed in a local HIV laboratories.

Viral RNA amplification is difficult in subjects with HIV-1 RNA levels \<500-1000 copies/mL. In these cases, the optimal source of genetic material is peripheral blood mononuclear cell (PBMC)-associated proviral DNA. Whereas genotypic tropism testing in proviral DNA is technically feasible, it has not been validated as a tool to predict sustained virological response to CCR5-antagonist therapy in subjects with undetectable viremia.

As of today, maraviroc is the only CCR5-antagonist approved for HIV treatment. It has few drug interactions and a good security profile, particularly in terms of lipid and glucose metabolism. Therefore, it might be an adequate alternative for HIV-1-infected individuals with suppressed viremia who experience antiretroviral-related toxicity or metabolic problems.

This study will evaluate 48-week virological outcomes in aviremic subjects with an R5 virus by proviral genotypic tropism testing who switch the "third drug" of their regimen to maraviroc.

Eligibility Criteria:
Inclusion Criteria:

1. HIV-1 infected patients.
2. Age 18 or more.
3. Antiretroviral treatment containing 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs) plus 1 Non-nucleoside reverse-transcriptase inhibitor (NNRTI) or 1 protease inhibitor (PI) or 1 integrase inhibitor (ININ)
4. Patients receiving stable antiretroviral treatment for at least 6 months.
5. Viral load under 50 copies/mL in the last 6 months
6. Patients with CCR5 tropism based in V3 genotyping in proviral DNA using the G2P with a false positive rate of 10% interpretation method.
7. A change of treatment is needed due to toxicity / tolerability problems with the 3rd drug (PI, NNRTI or ININ), according to investigator criteria.
8. An antiretroviral regimen containing a CCR5-antagonist is suitable for the patient (physician criteria).
9. Voluntary written informed consent.

Exclusion Criteria:

1. Pregnancy or breast-feeding.
2. Patient previously treated with maraviroc.
3. Patients with documented resistance to maraviroc or any other drug considered for the new ARV regimen.
4. Viral failure in the moment of inclusion.
5. Bad adherence history or anticipated (investigator criteria).
The Implication of ctDNA in the Recurrence Surveillance of Stage II and III Colorectal Cancer

This study is to evaluate circulating tumor DNA (ctDNA) as a predictive and surveillant method for tumor recurrence in stage II and III colorectal cancer (CRC).

This study will evaluate circulating tumor DNA (ctDNA) as a prognostic marker and as a monitor of a short-term disease recurrence in surgical resective stage II and stage III colorectal cancer (CRC). The investigators will recruit newly diagnosed CRC patients, systematically collect their blood samples at the following time point: before surgery, one week after surgery, every three months for the first year and every six months for the second year, which are coincidence with the recommended clinical follow-up. Patients' outcome and survival will be tracked. These study will permit assessment of ctDNA as a predictive and surveillant method for a short-term (two years) tumor recurrence in comparison with other parameters.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age on the day of signing informed consent.
* Patients must have histologically confirmed stage II or IIIcolorectal cancer.
* Patients must receive radical resection.
* Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study.

Exclusion Criteria:

* Patient has severe anemia.
* Patients received neoadjuvant treatment.
* Patients received blood transfusion two weeks before or during the surgical resection.
* Patient has any other conditions, which, in the opinion of the Investigator, would interfere with the evaluation of the subject
MUSic Therapy to Improve Quality Of Life in Sickle Cell Disease (MUSIQOLS)

The purpose of this pilot study is to investigate the effects of a 6-session music therapy protocol on the pain, mood, quality of life, coping skills, and self-efficacy of adult patients with sickle cell disease (SCD) as compared to adult patients with SCD who receive standard care alone. The investigators will also determine the feasibility (delivery, acceptability, and usefulness) of the music therapy intervention for pain management and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years or older
* Subject has a SCD diagnosis
* Subject fits chronic pain criteria in SCD
* Subject has a working email address
* Subject has access to a mobile device with email and internet capabilities
* Subject is able to speak and understand English
* Subject has attended at least 50% of his/her scheduled outpatient visits to the Adult SCD Clinic in the last 12 months

Exclusion Criteria:

* Subject has a significant visual impairment that has not been corrected
* Subject has a significant hearing impairment that has not been corrected
* Subject has a significant cognitive impairment that would prevent subject from participating in the study
Long-Term Patient-Reported Maternal Outcomes Following Abdominal Cerclage for the Prevention of Preterm Birth

This study aims to explore the maternal patient reported outcomes on pelvic pain sexual health anxiety and depression bladder discomfort foreign body sensation trust in the cerclage, and how these parameters affect the general health perception in the quality of life of women treated with abdominal cerclages in Denmark since 2004.


Eligibility Criteria:
Inclusion Criteria:

* Transabdominal cerclage

Exclusion Criteria:

* Most recent birth within 6 months
A 1-year Multi-center, Prospective, Cohort Study in Patients With Chronic Obstructive Pulmonary Disease Treated With Long-acting Bronchodilator

This multi-center study is designed to describe natural history of disease, treatment and health care products in physician-diagnosed COPD patients who require adding daily maintenance therapy in real world.

The study planned to enroll 550 patients in Indacaterol group and 9450 patients in non- Indacaterol group, a total of 10,000 patients. Enrollment was stopped at 2253 patients due to low recruitment in indacaterol group. Finally a total of 2229 patients were analyzed in full analysis set.

A total of 2253 patients entered into the database, of which 24 patients were exclude during the data review meetings, because they did not met the inclusion/exclusion criteria. Hence a total of 2229 patients enrolled successfully.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent
* Physician-diagnosis of COPD
* COPD patients requiring long-acting bronchodilator treatment
* Patients with spirometry available at baseline

Exclusion Criteria:

* Patients who have a diagnosis of asthma.
* Patients who had been hospitalized for a COPD exacerbation in the 4 weeks prior to Visit 1.
* Current clinical diagnosis of other chronic respiratory illnesses
* Concurrent participation in a clinical trial or use of an investigational drug.
* Active malignancy or history of malignancy of any organ system
* Pregnant or nursing (lactating) women
* Women of child-bearing potential with no contraception Other protocol-defined inclusion/exclusion criteria may apply.
Electrogastrography (EGC) in Premature Infants With Feeding Intolerance

Serial EGC measurements in premature infants attempting to correlate EGC measurements with signs of feeding intolerance and response to metoclopramide therapy.


Eligibility Criteria:
Inclusion:

Premature infants. Absence of 1) infection, 2) congenital anomalies, 3) growth retardation
Bump on the Ball: Impact of a Prenatal Exercise & Education Program on Birth Outcomes & Maternal Quality of Life

Operative vaginal delivery (with forceps or vacuums) is frequently performed secondary to maternal exhaustion, which leads to an inability to push effectively; 40% of operative vaginal deliveries at Prentice are for maternal exhaustion. The risk of severe birth trauma is increased three to four fold with operative delivery. This randomized, controlled trial will compare rates of operative vaginal delivery and severe birth trauma in two groups of women: (1) an intervention group who will participate in the antepartum Total Control® fitness and education program modified for pregnancy; and (2) a control group. Women will be recruited and followed from the second trimester until 6 weeks postpartum; all will complete validated questionnaires regarding their (1) level of worry and knowledge about their birthing experience (2) pelvic floor symptoms and quality of life (3) sexual function (4) satisfaction with their birthing experience and (5) level of depressive symptoms at various time points during and after their pregnancy. Obstetrical data will also be collected.

This will be a randomized controlled trial of primiparous women with singleton pregnancies who plan on delivering at Prentice Women's Hospital. Women will be recruited during their first trimester by their obstetrician as well as through standardized Northwestern Memorial Hospital flyers and ads. Demographic and delivery information will be obtained from the Northwestern Enterprise Data Warehouse (EDW), as well as by the attending midwife or physician at the time of delivery using a standardized Delivery Information Form. Women will also be asked about their other physical activities (including other forms of daily/weekly exercise) as well as whether or not they are participating in other birthing classes at the time of their first Total Control class (intervention group) or 2nd trimester visit with their providers (controls). All women will wear pedometers to track daily general activity.

Eligibility Criteria:
Inclusion Criteria:

* Singleton, primiparous pregnancy
* Delivering at Prentice Women's Hospital
* Able to participate based on PARmedX for pregnancy criteria

Exclusion Criteria:

* Non-english or Spanish speaking
* Age less than 18 years
* Known condition requiring cesarean section
* Currently enrolled in any kind of physical therapy
* Unable to complete the program secondary to medical limitations
Risedronate Sodium in Post Menopausal Osteoporosis

The primary objective is to compare subject satisfaction of once a week dosing of 35 mg Actonel to once daily dosing of 5 mg Actonel in postmenopausal osteoporotic women.

The secondary objectives are to measure compliance (50 % drug taken), and persistence, \[and urinary NTx (N-telopeptides) (optional)\].


Eligibility Criteria:
Inclusion Criteria:

* Five years or greater postmenopausal who present with a diagnosis of postmenopausal osteoporosis based on standard clinical practice criteria.
* Subjects must discontinue bisphosphonates, calcitonin, fluoride, glucocorticoids (≥ 5 mg prednisone or equivalent per day) and hormone replacement therapy including estrogen-related compounds at least 6 months prior to randomization. During the study, these drugs are not permitted other than the study medication, Actonel.
* Other concomitant medications should be kept to a minimum, but if the drugs are considered necessary for the subject's welfare and are unlikely to interfere with study medication, they may be given at the discretion of the Investigator.

Exclusion criteria :

* Had a history of cancer within the past 5 years. Relatively benign skin malignancies, such as basal cell carcinoma or squamous cell carcinoma, are not an exclusion criteria if the subject has been in remission for at least 6 months prior to enrollment.
* Diagnosis of hypocalcemia, hyperparathyroidism, and hyperthyroidism.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC)

To investigate the efficacy and safety of BIBW 2992 compared to standard first-line chemotherapy in patients with stage IIIB or IV adenocarcinoma of the lung harbouring an EGFR activating mutation


Eligibility Criteria:
Inclusion criteria:

1. pathologically confirmed diagnosis of stage IIIB or stage IV adenocarcinoma of the Lung
2. EGFR(Epidermal Growth Factor Receptor) mutation detected by central laboratory analysis of tumor biopsy material
3. Measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST)1.1
4. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
5. Age\>=18 years
6. life expectancy of at least three months
7. Written informed consent that is consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines.

Exclusion criteria:

1. Prior chemotherapy for relapsed and/or metastatic NSCLC.
2. Prior treatment with EGFR targeting small molecules or antibodies.
3. Radiotherapy or surgery(other than biopsy) within 4 weeks prior to randomization
4. Active brain metastases
5. Any other current malignancy or malignancy diagnosed within the past 5 years
6. Known pre-existing interstitial lung disease
7. Significant or recent acute gastrointestinal disorders with diarrhoea as a a major symptoms.
8. History or presence of clinically relevant cardiovascular abnormalities
9. Cardiac left ventricular function with resting ejection fraction of less than 50%.
10. Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test drug.
11. Absolute neutrophil count(ANC)\<1500/mm3
12. Platelet count\<100,000/mm3
13. Creatinine clearance\<60ml/min or serum creatinine\>1.5 times Upper Limit of Normal (ULN).
14. Bilirubin\>1.5 times ULN
15. Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) \> 3 times ULN
16. Women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial
17. Pregnancy of breast-feeding
18. Patients unable to comply with the protocol
19. Active hepatitis B infection, active hepatitis C infection or known HIV(Human Immunodeficiency Virus) carrier.
20. Known or suspected active drug or alcohol abuse.
21. requirement for treatment with any of the prohibited concomitant medications listed in section 4.2.2
22. Any contraindications for therapy with gemcitabine/cisplatin
23. Known hypersensitivity to BIBW2992 or the excipient of any of the trial drugs
24. Use of any investigational drug within 4 weeks of randomization.
The Effects of Feeding Different Levels of Docosahexaenoic Acid to Pre-School Children

This clinical trial will measure Docosahexaenic Acid (DHA) levels in the blood and evaluate the relation to cognitive outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Child is 3 years of age ± 90 days
* Weight for length is within 10th to 90th percentile as plotted on WHO growth charts
* Parent/caregiver reports that child consumes at least 6 oz of cow milk or cow milk-based beverages on a daily basis
* Parent is willing to exclude sources of DHA from child's diet during the study
* Parent agrees not to give vitamins to child during the study
* English is the primary language in the home
* Signed Informed Consent and Protected Health Information

Exclusion Criteria:

* Gestational age at birth ≤ 36 weeks
* History of neuro/psychiatric conditions
* History of underlying metabolic or chronic disease
* Child is ill, has used antihistamines or diagnosed with an infection at time of cognitive testing
* History of suspected or known cow milk protein intolerance
* Child's diet contains sources of supplemental DHA more than one time per week
* Child is from a multiple birth and the sibling(s) are living in the same household
* Child is enrolled in another interventional clinical research study
* Use of antihistamines within 12 hours of cognitive testing
Multiplanar Lumbopelvic Control in Patients With Low Back Pain

The purpose of this study was to investigate whether combined assessment of lumbopelvic control during sagittal and frontal plane motion (using two common clinical observational assessments) discriminates between people with and without LBP than single plane assessment alone. It was hypothesized that the two tests used in combination (multiplanar) would perform better than each test used independently (single planar) in accurately discriminating patient cases from healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* Patients with LBP

Inclusion Criteria:

* Age 18-70 years old
* Ability to understand and follow written and verbal instruction in English
* Seeking treatment from a physical therapist for LBP (pain below T12-L1 vertebral segment), prior to initial evaluation (no treatment provided)

Matched Controls: Control subjects will be matched for age, gender, and BMI category to patients with LBP.

Inclusion Criteria:

* Ability to understand and follow written and verbal instruction in English
* No history of LBP during the past 5 years requiring:

  * \> 3 day absence from work/school/recreation
  * Clinical Care (MD, DC, DPT, MT) for LBP

Exclusion Criteria:

Patients with LBP

* Pregnancy within past 12 months
* Previous spine or hip surgery
* Serious spinal or systemic pathology
* Inability to transfer from standing to supine to sidelying to prone
* Inability to stand \> 20 minutes

Matched Controls

Exclusion Criteria:

* Pregnancy within the past 12 months
* Previous spine or hip surgery
* Inability to transfer from standing to supine to side-lying to prone
* Inability to stand \> 20 minutes
Improving the Mental Health of Home Health Aides

The goal of this study is to improve the mental health of home health aides, a workforce that provides care for adults at home but whose own health has been historically poor. The main questions the study aims to answer are:

* Will a health program called Living Healthy, which provides health education and support with positive thinking, be used by home health aides and do they like it?
* Does Living Healthy actually improve home health aides' mood compared to what they usually do to take care of themselves?

Participants in the study will get an 8-week health program called Living Healthy over 3 months. Some of the participants will also have a 'peer coach' who is another home health aide who's been trained to help them with the program and learn some ways to feel better.

The study will compare the experiences of home health aides who get Living Healthy plus a peer coach with those who only get the Living Healthy program.

The overall goal of the proposed project is to improve the mental health of home health aides, one of the fastest growing sectors of the healthcare industry, comprised predominantly of middle-aged women of color with high levels of stress, depressive symptoms, and emotional exhaustion. Improving home health aides' mental health and well-being is not only critical to their own longevity as a workforce, but it has the potential to improve the health of the patients for whom they care. The investigators propose adapting the Living Healthy intervention, a 8-session peer coach-delivered cognitive behavioral therapy program on healthy habits, to the home health aide workforce and pilot testing it. The specific aim of this study is to conduct a 2-arm pilot randomized control trial among 100 home health aides (intervention arm: 50; enhanced usual care arm: 50) to evaluate the feasibility, acceptability, and preliminary effectiveness of the intervention compared to enhanced usual care (education on healthy habits alone). The primary hypothesis is that the intervention will be feasible (\>80% of aides will complete the program) and acceptable (\>90% of aides will report high levels of satisfaction). The secondary hypothesis is that participants who receive the intervention arm will experience fewer depressive symptoms at follow-up, compared to those in the control arm. Most of the study will be conducted virtually, while initial onboarding may be in-person.

Eligibility Criteria:
Inclusion Criteria:

* Currently working as a home health aide
* Speak English or Spanish
* ≥ 18 years of age
* Have mild depressive symptoms (Personal Health Questionnaire 8-item \[PHQ8\] scale ≥ 5 points), or other risk factors for poor mental health as assessed by the following domains including stress (Cohen's Perceived Stress 4-item scale \[PSS4\] ≥5) or loneliness (≥6 on the 3-item UCLA Loneliness scale).

Exclusion Criteria:

* Speak a language other than English or Spanish
* Less than 1 year of job experience as a home health aide
Socio-Emotional Development in Preterm Infants

With advances in medicine and medical technology, premature infants born as early as 24 weeks of gestation and with birth weight less than 1000 grams are surviving today. Preterms are born with immature biological systems. Given their biological vulnerabilities, preterm infants are at risk for a variety of health and developmental problems.

As a group, preterms show developmental delays in physical growth, motor skills, attention, social communicative skills, intelligence, language, academic performance, and later behavior problems. Furthermore, research indicates that preterms are difficult social partners for their parents.

Despite biological insults and relational difficulties, research also shows that the development of premature infants appears to be facilitated by sensitive and responsive parenting. Little attention, however, has been paid to understand the social risks faced by preterm infants.

The proposed research, therefore, is designed to:

1. understand the extent to which neurophysiological risk may affect preterm infants' socioemotional development,
2. explore the role of maternal social support, sociopsychological stress, and perception of infant vulnerability in the socioemotional development of preterm infants varying in biological risk,
3. examine the role of social support in buffering stress in mothers of preterm infants, and
4. evaluate the role of maternal stress, coping, and support in preterm infants' socioemotional development.

This study will include preterm infants recruited from the National Taiwan University Hospital at term and 12 months of corrected age. Infants will be examined for physical growth, neurobehavioral development, and mother and infant interaction at term. The growth measures including weight, height and head circumference will be assessed. Interaction between mother and infant will be investigated by observing the interaction between infants and their mothers in feeding and skin to skin contact conditions. Mothers' psychosocial stress and social support will be obtained via questionnaires.

It is expected that preterm infants' physical growth and neurobehavioral development as well as mothers' psychosocial stress and social support are associated with the quality of mother-infant interaction.


Eligibility Criteria:
Inclusion Criteria:

* preterm infants

Exclusion Criteria:

* significant congenital problems