cyrilzakka/clinical-trials huggingface dataset:
Antiretroviral Speed Access Program

Migrant populations represent an increasing proportion of newly referred people living with HIV in Canada, particularly in Quebec. Timely HIV care of newly referred patients has important individual-level health benefits that can result in decreased transmission and benefit the society as a whole. Yet, the timing of events in the HIV care cascade (from linkage to care to sustained viral suppression) together with the specific experience of care of these vulnerable populations (asylum-seekers, international students, patients with no status) who often face specific psycho-social and/or financial issues, has rarely been studied. In particular, little is known about their experience of HIV care whether they are referred to a multidisciplinary clinic or a physician-only clinic.

In a context where B/F/TAF will be provided free-of-charge to all enrolled participants including migrant populations, we aim to investigate what model of care can best address current deficiencies in the standard HIV care cascade for newly-referred patients, which often involves delays in linkage to care and starting ART.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. Newly referred at the study site
3. HIV-1 infected (fourth generation HIV Ag/Ab combination assay)
4. Treatment-naïve to all anti-HIV therapy, except for the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening
5. Estimated GFR \>30 mL/min/1.73m2 according to the Cockcroft-Gault formula for creatinine clearance
6. Must be willing and able to understand the requirements of study participation and provide signed and dated written informed consent prior to screening
7. Female participants who are willing to use acceptable methods of birth control as defined in the protocol

Exclusion Criteria:

1. Have received anti-HIV therapy previously, except for PrEP or PEP taken up to one month prior to screening
2. Viral load \<100 copies/mL, high suspicion of non-reported ART use or being a long-term nonprogressor or elite controller
3. Concomitant use of drugs with contraindication or drug-drug interactions with B/F/TAF
4. Documented historic or baseline allergy to any of the components of B/F/TAF
5. Estimated eGFR (by Cockcroft-Gault formula) \< 30 mL/min
6. Pregnant, breast-feeding or planning or suspected to get pregnant
7. Involvement in any other interventional HIV studies during the study period
8. Has any reason, in the opinion of the investigator, which would make the candidate inappropriate for participation in an investigative study involving oral medications
Expanded Access to ABBV-8E12

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to ABBV-8E12 prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility Criteria:
PPCM Observational Study (Peripartum Cardiomyopathy)

The purpose of this study is to examine the clinical treatment of patients diagnosed with peripartum cardiomyopathy complicated by cardiogenic shock.

This single-site, virtual, longitudinal, observational study will investigate two cohorts (study groups) by enrolling a total of ten participants, five in each cohort. The two cohorts include individuals who received mechanical circulatory support (specifically the IMPELLA® device) compared to individuals who did not receive mechanical circulatory support for treatment of their PPCM complicated by cardiogenic shock index event.

The duration of enrollment for each participant is about 5 months. It is anticipated that the trial will be complete in 12 months. Participant engagement to the study will be self-initiated.

Under the guidance and support of Medical College of Wisconsin research coordinator, participants will directly access the study REDCapTM database for enrollment and follow-up data entry for this study. The research coordinator will obtain and abstract participant medical records documenting the event.

Eligibility Criteria:
Inclusion Criteria:

Females:

* age ≥ 18 years old at the time of entry into the study
* who have capacity to provide consent for study participation
* with self-reported PPCM complicated by cardiogenic shock
* individuals should have US citizenship
* index event occurring within the continental United States.

Exclusion Criteria:

* lack of medical records supporting pregnancy, peripartum cardiomyopathy or cardiogenic shock by study definition
* inability of participant to provide informed consent
A Study of HIV-Disease Development in Aging

The purpose of this study is to better understand the relationship between age and HIV disease progression.

This study will explore the possible relationship between age and HIV disease progression. Older age is an important risk factor for faster disease development, but older people may respond better to combination drug therapy. This relationship needs to be understood better.

Older age is an important risk factor for accelerated HIV-disease progression. However, the virologic response to highly active antiretroviral therapy (HAART) may be superior in older persons. A better understanding of the immunologic, virologic, and behavioral mechanisms that underlie these age-related differences may help to elucidate critical immune responses that are necessary to control the progression of HIV-disease.

Patients are grouped according to age. Group A consists of patients between the ages of 13 and 30 years. Group B consists of patients age 45 years or older. All patients receive open-label lopinavir/ritonavir (LPV/RTV) plus emtricitabine (FTC) plus stavudine (d4T) for 96 \[AS PER AMENDMENT 06/04/02: 192\] weeks. Study visits occur at pre-entry, entry, and Weeks 4, 8, 12, 16, and 24 then every 12 weeks thereafter through Week 96 \[AS PER AMENDMENT 06/04/02: Week 192\]. Clinical assessments, safety laboratory tests, CD4 cell count monitoring, lymphocyte phenotyping, and HIV-1 RNA determinations are performed routinely. Blood samples are stored for further immunology and virology studies. Patients may volunteer to participate in virology substudy A5020s and either immunology substudy A5016s or A5017s \[AS PER AMENDMENT 06/04/02: Substudy A5017s has been eliminated.\]

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Are between 13 and 30 years old (need consent of parent or guardian if under 18), or are more than 44 years of age.
* Have a viral load of more than 2000 copies/ml within 60 days of study entry.
* Have a CD4 cell count of less than 600 cells/mm3 within 60 days of study entry. (This reflects a change in the CD4 cell count requirement.)
* Agree to use effective methods of birth control (such as condoms) during and for 12 weeks after the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Are pregnant or breast-feeding.
* Have an AIDS-related cancer (except Kaposi's sarcoma) requiring chemotherapy.
* Have hepatitis within 30 days of study entry.
* Have diarrhea (more than 3 liquid stools/day for at least 14 days) within 30 days of study entry.
* Are receiving chemotherapy or radiation treatment.
* Have taken antiretroviral drugs for more than 14 days.
* Have received an HIV vaccine within 30 days of study.
* Have a serious illness or infection within 14 days of the study.
* Have other serious conditions that might interfere with study participation.
* Have taken or plan to take certain other drugs that might affect the study results.
Post-operative Pain Relief in Laparoscopic Cholecystectomy

compare the analgesic efficacy of the combination of bupivacaine and morphine, bupivacaine and fentanyl and bupivacaine and ketamine in alleviating post operative pain following laparoscopic cholecystectomy.

Laparoscopic cholecystectomy is comparatively advantageous over open cholecystectomy in pain management with shorter duration of hospital stays. Pain management is medically pertinent for optimal care in surgical patients. Although development and advancement in understanding of the patho-physiology of pain, analgesics, pharmacology and the development of better effective techniques for post-operative pain control, patients still continue to experience considerable discomfort.

Laparotomy results in parietal pain, whereas laparoscopy has a visceral component, a somatic component and shoulder pain secondary to diaphragmatic irritation because of CO2 pneumo-peritoneum. Postoperative pain associated with laparoscopic cholecystectomy, although less severe and of shorter duration than that after open cholecystectomy, is still a source of marked discomfort and surgical stress. The degree of the pain after laparoscopic procedures has multifactorial influence including the volume of residual gas, type of gas used for pneumo-peritoneum, pressure created by the pneumo-peritoneum and insufflated gas temperature.

Local anesthetic infiltration of the incision sites decreases postoperative opiate requirement and improves subjective pain scores but does eliminate the pain.

Earlier scientists have also reported several beneficial effects of the intra-peritoneal application of bupivacaine with morphine on postoperative pain management after laparoscopic cholecystectomy.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) classification I and II
* scheduled for elective laparoscopic cholecystectomy
* under a standardized general anesthesia technique.

Exclusion Criteria:

* uncooperative, unwilling,
* history of anaphylaxis to local anesthetics and/or opioids and the drugs to be used,
* history of drug abuse,
* anmorbidly obese patients,
* ASA classification III, IV, V
* d patients having any other significant co-morbidities
* any other with psychiatric disease
* pregnant women
Serum Autotaxin Levels in Cholestasis of Pregnancy

Intrahepatic cholestasis of pregnancy is the most common liver disease in pregnancy. It is is a pregnancy-specific liver disorder with onset mainly in the third trimester of pregnancy. ICP is characterized by pruritus, elevated serum fasting bile salts and transaminases and an increased risk of adverse fetal outcomes. Serum autotaxin levels were found highly sensitive and specific biomarker to to differentiate ICP from other pregnancy-related liver disorders or pruritic dermatoses. The purpose of the study is to determine the diagnostic accuracy of serum autotaxin activity in cholestasis of pregnancy.

Collected data will enable us to compare serum autotaxin levels in cholestasis of pregnancy and healthy control group.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosed cholestasis of pregnancy patients

Exclusion Criteria:

* acute or chronic liver disease
* acute or chronic gallbladder disease
Alive & Thrive Nigeria Impact Evaluation

Investigators will use a cluster-randomized design to evaluate the overall impact of the Alive \& Thrive infant and young child feeding communication strategies in Lagos and Kaduna States, Nigeria. The impact in each state and in a subset of urban local government areas (LGAs) will also be tested.This is a mixed methods evaluation; the quantitative data will be complemented by qualitative data obtained from different groups targeted by or involved in the program.

Adequate nutrition during the first 1,000 days is necessary for children to grow and develop to their full potential. Alive \& Thrive (A\&T) contributes to better nutrition during the first 1,000 days by promoting improved infant and young child feeding (IYCF) practices. A\&T is expanding its efforts to Nigeria and will target Lagos and Kaduna States. In Nigeria, 33% of infants are breastfed within 1 hour of delivery, 60% are given other fluids in the first 3 days of life, and only 17% of children 0-5.9 months are exclusively breastfed. Approximately 60% of children 6 to 23 months achieve the minimum meal frequency for their age and 19% are fed four or more food groups per day. To address these gaps in optimal IYCF practices, A\&T will use an implementation framework for IYCF impact at scale that includes advocacy, interpersonal communication and community mobilization, mass communication, and strategic use of data. The A\&T intervention will be compared to mass media communication on IYCF, which will be provided throughout the two states. LGAs in Lagos and Kaduna will be randomly allocated such that two-thirds receive the A\&T intervention and one-third are assigned to the comparison group. The primary objectives of the evaluation are to measure the impact of the A\&T intervention on IYCF practices among mothers with children 0-23 months of age overall, in each state, and in a subset of urban LGAs. Secondary evaluation objectives are to document: the type, quantity, and timing of the implementation of A\&T program activities; coverage levels A\&T achieves with different program activities; extent to which A\&T increases knowledge and awareness of optimal IYCF practices among women with children 0 to 23 months and health providers; extent to which A\&T improves the capacity of health providers to counsel mothers on IYCF; and extent to which A\&T improves the capacity of stakeholders to implement community-based activities that support optimal IYCF practices.

Eligibility Criteria:
Inclusion Criteria:

* For mother's survey:
* Women of reproductive age (15-49 years),
* Must be married if 15-17 years,
* Has a child 0-23 months
* For provider's survey:
* Male or female,
* 18 years or older
* Works in a government or private health facility or works as a community pharmacist, private patent medicine vendor, or traditional birth attendant

Exclusion Criteria:

-
Evaluation of Thyroid Function in Patients With Chronic Kidney Disease

A higher prevalence of thyroid disease has been associated with chronic kidney disease (CKD), and subclinical hypothyroidism seems to be the most common dysfunction. The aim is to evaluate thyroid function and autoimmunity in patients with CKD stages 3, 4 and 5. Cross-sectional study to be carried out on patients with stages 3 and 4 in a Nephrology outpatient clinic. Thyroid function is evaluated by measuring thyroid stimulating hormone (TSH), free thyroxine, free triiodothyronine and antithyroperoxidase antibodies (TPOAb) levels.

Cross-sectional study to be carried out on patients with stages 3, 4 and 5 in a Nephrology outpatient clinic. Thyroid function is evaluated by measuring thyroid stimulating hormone (TSH), free thyroxine, free triiodothyronine and antithyroperoxidase antibodies (TPOAb) levels. Free Thyroxine (FT4) will be measured by liquid chromatography tandem mass spectrometry and electrochemiluminescence immunoassay in order to compare methods in this population.

The glomerular filtration rate was estimated (eGFR) by the Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI), and the CKD stages were defined according to the Kidney Disease Improving Global Outcomes directives (KDIGO).

Eligibility Criteria:
Inclusion Criteria:Patients over 18 years old with CKD stages 3 and 4 were included in the study.

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Exclusion Criteria: 1) acute systemic inflammatory disease; 2) pituitary disease in the past or present; 3) regular treatment with amiodarone, lithium, interferon, immunosuppressive drugs and glucocorticoids; 4) previously diagnosed hypothyroidism and undergoing levothyroxine replacement.

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Meditative Neurofeedback for Depression

The goal of this open-label single-arm study is to test a meditative neurofeedback intervention for depressed mood.

The goal of this open-label single-arm study is to test whether a 10-session meditative neurofeedback intervention significantly alleviates depressive symptons as well as improves secondary outcomes of rumination and mindfulness.

Eligibility Criteria:
Inclusion Criteria:

* moderate depression per PHQ9 symptom ratings

Exclusion Criteria:

* active substance abuse/dependence
* psychotic disorders
* bipolar disorder
* displaying acutely suicidal behaviors
Effect of Multiple Micronutrient Fortified Bread Consumption on Iron Deficiency Anemia in Women of Reproductive Age

The project aims to assess if consuming two slices of multi-fortified bread daily for 120 days is effective in reducing iron deficiency anemia in women of reproductive age through a three-arm randomized trial.

Iron deficiency anemia (IDA) continues to be a public health priority in Peru and the world. The prevalence of the condition is high in women of reproductive age regardless of geographic area and socioeconomic status. Fortification of staple foods is recognized as a cost-effective strategy to reverse iron deficiency. In Peru, iron fortification of wheat flour and derived products is mandatory, but to date its effect on the IDA has not been evaluated. In recent years, evidence has been generated on the positive effect of zinc, vitamin A and vitamin B12 supplementation on hemoglobin (Hb) levels. This project is a three-arm randomized clinical trial that seeks to evaluate the effect of consuming two slices of bread fortified with a multivitamin premix (iron, folic acid, vitamin A, vitamin B12 and zinc) daily on iron deficiency anemia in non-pregnant women of reproductive age. As a control, one group will receive standard bread fortified according to Peruvian legislation and a third group will not receive treatment.

Eligibility Criteria:
Inclusion Criteria:

* Ferritin levels \< 13 ng/ml,
* Hemoglobin levels between 8 g/dL and 11.9 g/dL,
* No plans to move during the duration of the study,
* Commitment not to become pregnant during the duration of the study,
* Signed informed consent.

Exclusion Criteria:

* Pregnancy,
* Amenorrhea not related to pregnancy,
* Breastfeeding,
* Chronic diseases (active TB, HIV, cancer, asthma, liver disease, coronary heart disease, chronic renal disease),
* Hemoglobin levels \< 8 g/dL,
* Bleeding in the 3 months prior to recruitment,
* Smoking,
* Inability to sign informed consent,
* Consumption of nutritional supplements.
Nursing and Nurturing Premature Infants

The purpose of this study is to determine whether systematic use of the Newborn Individualized Developmental Care Assessment Program (NIDCAP®) improves the neurologic development of children and the parental competence of mothers.

Background: The unborn infant's brain is growing from the fifth month of fetal life which makes preterm babies sensitive to environmental influence. Therefore, to prevent developmental brain injury is an essential goal for neonatal nurses.

Purpose: The study investigates whether systematic use of Newborn Individualized Developmental Care Assessment Program (NIDCAP®) improves the neurological development of preterm babies and the parental competence of mothers.

Design: This study compares postnatal care of preterm babies in two neonatal units.

Participants: Preterm infants born before 32 weeks' gestational age and their mothers.

Instruments:

* Preterm babies' behaviour in intervention and control groups is observed every 7-12 days using scoring sheets.
* Questionnaires focusing on maternal self esteem when the baby is 4 weeks and again at 3 and 18 months and 5 years.

Expected outcomes:

* Infants: less time with treatment using CPAP and oxygen, growth, time of discharge and pattern of motor behaviour.
* Mothers: self reported experiences of self esteem.

Analysis: t-test Expected implications: In a health promotion perspective the systematic NIDCAP program hopefully will constitute a more competent mother, knowledgeable in child care and parental management. The intervention NIDCAP®-care infant group is expected to increase in growth compared to the control group, their motor system will be more mature, and there will be an earlier discharge, all factors contributing positively to health economy.

Eligibility Criteria:
Inclusion Criteria:

* Premature infants
* The infants' biological mothers

Exclusion Criteria:

* Premature infants with chromosomal anomaly
* Mothers who cannot read and understand Danish
Understanding Variability in Behavioral Weight Loss Treatment Response in Young Women (Ready SET Health)

This study is a single-arm behavioral weight loss intervention for emerging adult women with in-person assessments at 0 (baseline) and 4 months (post-treatment) in addition to EMA data collection regarding risk factors known to interfere with program engagement and weight loss in this high-risk population (e.g., sleep, psychological distress, life events).

This study will implement a 4-month Internet-based behavioral weight loss intervention in order to collect ecological momentary assessment (EMA) data that will shed light on real-time barriers to weight management. The intervention is evidence-based and adapted with respect to content and delivery mode in order to meet the needs of emerging adult women. Consenting and eligible participants will receive 1 virtual group session led by a trained interventionist followed by weekly emails directing them to an intervention website housing video and .pdf content, weekly text messages, emailed tailored feedback regarding their weight loss behaviors and progress, and a closed Facebook group to facilitate social support. All participants will be followed for 4 months with hybrid in-person/virtual assessments at 0 and 4 months; in addition, all participants will be asked to respond to EMA prompts throughout the 4-month intervention period (Week 2, Week 4, Week 7, and Week 13).

Eligibility Criteria:
Inclusion Criteria:

* 18-25 years of age
* BMI (body mass index) 25-45 kg/m2
* Female gender identity

Exclusion Criteria:

* Report of uncontrolled medical condition that may pose a safety issue given the recommendations for the diet and unsupervised physical activity
* Diagnosed cardiovascular or metabolic disease
* Report of a heart condition, chest pain during periods of activity or rest, or loss of consciousness
* Recent change in use of medications that may impact weight or metabolic function
* Cancer in the past 5 years, except non-melanoma skin cancers or early-stage cervical cancer
* Current symptoms of alcohol or other substance dependence
* Report of diagnosis or history of Anorexia Nervosa or Bulimia Nervosa, or any compensatory behaviors within the previous 3 months
* Hospitalization for depression or other psychiatric disorder within the past 12 months
* Lifetime history of bipolar disorder or psychotic disorder
* Planning to move from the area within the study period
* Currently pregnant, pregnant within the past 6 months, currently breastfeeding or planning to become pregnant within the next 6 months
* Current involvement in a weight loss program or current use of weight loss medication
* Recent significant weight loss
* Inability to read or speak English
* Lack of a smartphone or unwillingness to use it for study components