cyrilzakka/clinical-trials huggingface dataset:
Prevalence and Risk Factors for Micronutrient Deficiencies During Pregnancy in Cayenne, French Guiana

Micronutrient deficiencies are frequent in pregnant women in French Guiana, a French territory in South America. Micronutrient deficiencies are more frequent in precarious women. Obesity is a frequent problem but it is also associated with micronutrient deficiency. Micronutrient deficiencies have largely been overlooked in this outermost European region and should be corrected.

Involved in physical and brain development, immunity and metabolism, micronutrients have profound health effects. The nutritional status of pregnant women is a major determinant of fetal health. French Guiana has a rapid population growth. Social inequalities, cultural practices and gastrointestinal nematode infections in French Guiana could affect the prevalence of these deficiencies. The main objective of the present study was to estimate the prevalence of micronutrient deficiency among pregnant women in French Guiana. The secondary objective was to identify socio-demographic, dietary, obstetrical and neonatal risk factors associated with deficiencies.

Pregnant women over 22 weeks of pregnancy hospitalized for delivery at the Obstetrical Emergency Department of the Hospital Center in Cayenne from May 2018 to March 2019 were included. A socio-demographic and food questionnaire was administered. Medical data were collected from the medical records. Blood and urine samples were taken. The descriptive analysis used Student and Chi2 tests.

A total of 341 women were included. The majority were born in Haiti (39%) and French Guiana (34%). At least one micronutrient deficiency was observed in 81% of women. Precarious women had a significantly greater risk of micronutrient deficiency during pregnancy compared to those with both normal and complementary health insurance.

Micronutrient deficiencies in pregnant women in French Guiana are a public health problem, a fact that was previously overlooked in a context of rising obesity. With over half of women overweight or obese and 81% with at least 1 micronutrient deficiency, balanced nutrition should be a major focus.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant at least 22 weeks of amenorrhea (WHO threshold for fetal viability)
* Patient hospitalized for delivery in the Gynecological and Obstetrical Emergency Unit at Cayenne hospital
* Patient's consent
* Consent of the legal representative if the patient is a minor

Exclusion Criteria:

* Refusalto participate in the study.
* Being under guardianship or curatorship
* Having been previously enrolled in the study
The Effect of Oral Feeding Model With a Chronobiological Approach in Preterm Infants

As in healthy term babies, the ideal food for preterm infants and sick term babies is breast milk. There are many studies indicating that the composition of breast milk can vary from mother to mother, according to the gestational week of the baby and gender. In new researches on breast milk content; It is argued that breast milk is different during the day and at night, that the micro and macro nutrient content, hormones and some enzymes show different levels of secretion at different times of the day, and that breast milk has a circadian rhythm.

This research is designed as a prospective, randomized, controlled type. The study will be carried out in order to evaluate the effect of Chronobiological Approach Nutrition Model application on baby's growth parameters and discharge time in preterm babies hospitalized in Neonatal Intensive Care Unit (NICU).

Simple randomization method will be used for the study and the babies will be divided into intervention(n=40) and control groups(n=40). The research was carried out with 80 babies followed up in the neonatal intensive care unit.

The milk of the intervention group patients will be matched circadian and given to the babies, the milk of the control group patients will be given without matching according to the clinical routine practice. Demographic data, anthropometric measurements (weight, height, head circumference of all babies will be recorded in the "Baby Monitoring Form" created by the researcher.

Circadian fluctuations in breast milk content are very important in preterm infants fed with expressed breast milk. The composition of breast milk varies throughout the day. In the literature, there is no randomized controlled study suggesting that the breast milk of infants fed with expressed milk should be matched to the baby circadian. In this study, it was aimed to evaluate the effect of Chronobiological Approach Model application on preterm infants growth parameters and discharge time in feeding of preterm infants hospitalized in the neonatal intensive care unit . It is aimed to accelerate the growth of babies by making circadian matching to breast milk in feeding preterm infants and to increase the quality of nursing practices by reducing the length of hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight \>1400 \<2500 gram and gestational week ≥32-37 weeks
* Who are feeding only human milk
* Fully enterally fed babies (50-100ml / kg / day)
* Whose parents signed the informed consent to participate in the study were included.

Exclusion Criteria:

* Infants who cannot feed with human milk
* Who receive intravenous fluid, total parenteral nutrition or mixed fluid
* Infants with major congenital, cardiac, respiratory or airway abnormalities and infants who require additional pressure and respiratory support
* Metabolic imbalances, hypoglycemia or electrolyte imbalance
* Narcotic analgesic or sedation therapy
* Whose parents did not sign the informed consent were excluded.
Study Regarding the Clinical Efficacy of Synatura® in Patients With Chronic Bronchitis Type COPD

This study aims to examine the clinical efficacy of synatura in patients with chronic bronchitis type COPD in Korea.

Synatura® is a drug commonly used to suppress cough and sputum in patients with acute upper respiratory tract infection and chronic inflammatory bronchitis. According to the Phase III studies conducted in Korea, the safety and efficacy of Synatura® on antitussive and expectorant effects were confirmed in patients with acute upper respiratory infection and chronic inflammatory bronchitis. However, no studies have been conducted for the effects of Synatura® in patients with COPD. COPD is divided into emphysema type and chronic bronchitis type, while typical clinical symptoms of chronic bronchitis are cough and sputum. Therefore, Synatura®, which is effective for chronic bronchitis, is expected to be effective in patients with chronic bronchitis accompanied by COPD.

Eligibility Criteria:
Inclusion Criteria:

1. Post bronchodilator FEV1/FVC \< 0.7
2. Smoking history of ≥10 packs per year
3. 40 to \<75 years of age
4. Patients with symptoms of chronic bronchitis (in case they have symptoms of cough or sputum over 3 months)

Exclusion Criteria:

1. Patients with acute exacerbation
2. Patients with pneumonia
3. Patients with active tuberculosis
4. Pregnant women
5. Breast-feeding women
6. Patients with fructose intolerance
MEOI and HRQoL in CLL Patients Treated With BTKis

This is a multi-site observational study of medical events of interest (MEOI) and health-related quality of life (HRQoL) in chronic lymphocytic leukemia (CLL) patients initiating treatment with the Bruton's tyrosine kinase inhibitors (BTKi) acalabrutinib or ibrutinib in the United States (US)


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Physician-confirmed diagnosis of CLL or small lymphocytic lymphoma (SLL)
* BTKi naïve patients who initiate acalabrutinib or ibrutinib treatment alone or in combination with an anti-CD20 mAb within 7 days (before or after) study enrollment\*. Both treatment naïve and relapsed/refractory CLL patients will be included.
* Provides informed consent
* Adequate English reading skills
* Able to access and use a computer, tablet, or smartphone to complete PROs

Exclusion Criteria:

* Use of BTKi any time prior to study enrollment.
* Currently receiving systemic treatment for another malignancy
* Currently enrolled in a clinical trial
Improving Antibiotic Use for ARIs in Urgent Care Clinics

Many clinicians prescribe antibiotics for patients with acute respiratory infections even when antibiotics will not benefit the patient because the infection is due to a virus. To discourage this type of unnecessary antibiotic use, the investigators will assess whether it is helpful to give clinicians feedback on how often they prescribe antibiotics for respiratory infections in comparison to their peers. The investigators will perform this study across Urgent Care and QuickCare clinics within a single healthcare system.

The investigators have used an established HEDIS (Healthcare Effectiveness Data and Information Set) metric to evaluate Urgent Care and QuickCare clinicians on their antibiotic use for respiratory tract diagnoses (RTDs). This RTD metric excludes visits that are more complicated, based on well-defined criteria. Based on our baseline assessment (2018-2022), the investigators estimate that most clinicians in this setting are frequently prescribing unnecessary antibiotics.

The investigators will perform a randomized controlled trial to assess whether providing individualized feedback to clinicians on the RTD metric can safely reduce antibiotic use for qualifying respiratory tract visits across Urgent and QuickCare settings within a single integrated healthcare system. Clinicians who do not opt-out of the trial will be randomized to either receive feedback or not receive feedback on this RTD metric. The trial will last for 18 months. The primary outcome of effectiveness will be the frequency of antibiotic-prescribing for RTD visits. Secondary outcomes include total antibiotic use (regardless of diagnosis), changes in the use of diagnostic codes, 30-day rates of follow-up visits and hospital admissions. The RE-AIM framework will be used to guide additional study evaluation.

Eligibility Criteria:
Any clinician who works in Urgent Care or QuickCare clinics within our healthcare system.
ImplemeNtation oF demOnstration pRoject for Health systeMs: Atrial Fibrillation (INFORM-AF) Part 1

The goal of this study is to learn about the patient and provider perceptions, priorities, preferences, and willingness to use/prescribe anticoagulation as a stroke prevention therapy in patients with atrial fibrillation. Qualitative interviews will be performed with atrial fibrillation patients and providers caring for atrial fibrillation patients. The investigators want to understand the factors that influence decision-making about anticoagulation medications, and to gain insight into patients' and providers' knowledge of the risk of stroke and bleeding associated with oral anticoagulation. This feedback will help provide better education to providers caring for patients with atrial fibrillation and better care to patients with atrial fibrillation by developing tools to optimize the appropriate use of oral anticoagulation for patients with atrial fibrillation.


Eligibility Criteria:
Patient Inclusion Criteria:

1. adult patient age 18 or older;
2. English speaking;
3. diagnosed atrial fibrillation;
4. at least 1 risk factor for congestive heart failure, hypertension, age, diabetes, stroke (CHADS2) or 2 risk factors for CHADS2 with vascular disease, age, and sex (CHADS2-VASc) ;
5. no documented cognitive impairment per the medical record;
6. not being prescribed an oral anticoagulant

Provider Inclusion Criteria:

1. physician at one of the study sites treating patients diagnosed with atrial fibrillation

Exclusion Criteria:

* None
Naltrexone in the Treatment of Trichotillomania

This is an 8-week, double-blind study of Natrexone in the treatment of trichotillomania

The goal of the proposed study is to evaluate the efficacy of Naltrexone in trichotillomania. Forty subjects with DSM-IV trichotillomania will receive 8 weeks of double-blind Naltrexone or placebo. The hypothesis to be tested is that Naltrexone will be effective and well tolerated in patients with trichotillomania compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Eligibility Criteria:
Inclusion Criteria:

1. men and women age 18-75;
2. current DSM-IV trichotillomania;
3. hair-pulling primarily due to urges/cravings; and 4) pulling is reported as pleasurable the majority of time.

Exclusion Criteria:

1. unstable medical illness or clinically significant abnormalities on pre-study laboratory tests or physical examination;
2. history of seizures;
3. myocardial infarction within 6 months;
4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
5. clinically significant suicidality;
6. current or recent (past 3 months) DSM-IV substance abuse or dependence;
7. illegal substance within 2 weeks of study initiation;
8. initiation of psychotherapy or behavior therapy from a mental health professional for the treatment of trichotillomania within 3 months prior to study baseline;
9. initiation of a psychotropic medication within 2 months prior to study inclusion;
10. previous treatment with naltrexone; and
11. treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline;
12. lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;
13. current use of opiates.
A Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Lung Transplant Recipients With Post-transplant Treatment With Mavyret

Patients who are Hepatitis C Negative (HCV negative) and are on the waiting list for a lung transplant at NYULH who consent to participate in this study will receive a lung transplant from a deceased donor that is HCV positive. Patients will initiate treatment for HCV with the pan-genotypic agent, Mavyret, on the day of surgery and will complete the full 8-week treatment course. Patients will be monitored post-transplant for the development of viremia, and for the time course of clearance of viremia among those who develop viremia.


Eligibility Criteria:
Inclusion Criteria:

Recipient criteria:

* Listed for an isolated lung transplant at NYU Langone Health
* Between 18-70 years of age
* Able to travel to the NYU Langone Health for routine post-transplant visits and study visits for a minimum of 6 months after transplantation
* No active illicit substance abuse
* Weight at least 40kg
* Women of childbearing potential must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) after transplant due to the increased risk of birth defects and/or miscarriage
* Both men and women must agree to use at least one barrier method after transplant to prevent any secretion exchange
* Able and willing to provide informed consent

Donor criteria:

* Detectable HCV RNA by nucleic acid test (NAT) or positive anti-HCV antibody
* Donor lung meets standard NYU Langone Health clinical criteria for procurement

Exclusion Criteria:

Recipient criteria:

* HIV positive
* HCV RNA positive or history of previously treated HCV
* Evidence of active hepatitis B infection or on active antiviral treatment for HBV
* Pregnant or nursing (lactating) women
* Use of strong CYP3A inducers
* Requires multi-organ transplant

Donor criteria:

* Confirmed HIV positive
* Confirmed HBV positive (positive hepatitis B surface antigen, and/or detectable Hepatitis B virus DNA)
* Known previously failed treatment for HCV
* Donor age \>60 years
Perception About Upper Limb Functional Recovery, Barriers & Use of Training Devices Among Indian Stroke Survivors.

The goal of this observational study is to evaluate perceptions regarding affected arm and hand function and their willingness to use devices to enhance upper limb functions among stroke survivors. The main question\[s\] it aims to answer are:

* what will the stroke survivor's perception of interventions and device development in his/her arm recovery?
* Wheather he is willing to use it for his arm recovery?

Individuals with stroke will be recruited from MGM Hospital and other hospitals from Aurangabad. Participants will be adults (age \>30) with stroke and with the capacity to provide written or verbal informed consent, and the ability to communicate verbally/online/phone. Participants will be contacted via phone or email by a member of the research team. If needed personal interviews of the patients will be taken. The research team will consist of the author and one helper Physical Therapy student and the guide. All team members participating in the training will ensure consistency in communications with participants. All the participants will be provided with information about the study objectives and procedures and will be asked if they are willing to participate. If they consent, they will be given one of three options:

1. Complete the survey via phone immediately
2. Complete the survey online. In this case, they will be sent a link to their email to complete an online survey.
3. Complete the survey via personal interview

Eligibility Criteria:
* Inclusion Criteria:
* First-ever stroke
* All stages of stroke
* Onset of a stroke at least 1 year ago
* Age group: 30 to 75
* Both genders included
* Patients diagnosed with MCA (Middle Cerebral Artery) stroke
* Exclusion Criteria:
* Aphasia
* Patients who are unable to follow commands
* Patients with other neurological disorders such as Multiple sclerosis and Parkinson's disease
The GRADE Capillary Blood Collection Pilot Study

This pilot study is planned to validate the comparability of HbA1c results obtained from whole blood collection via venous phlebotomy versus a capillary collection of whole blood. The participant will self-collect capillary blood into HbA1c prep vials containing a buffer; these prep vials will be sent to the CBL at ambient temperature via US Postal System (USPS) mail. The feasibility of self-collection of these capillary samples by GRADE participants will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Current GRADE participant with a scheduled follow-up visit

Exclusion Criteria:

* GRADE participants attending first quarterly (Month 3) visit or an annual visit
Ibrance Real World Insights

To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments in line with regional licensed indications in real world settings across multiple countries.


Eligibility Criteria:
Physician inclusion criteria

* Oncologist or gynecologist
* Responsible for treating a minimum of ≥2-6 (depending on country) ABC/MBC patients who meet the eligibility criteria.
* Agrees to participate in the study and complete the eCRFs within the data collection period.

Patient inclusion criteria

* Female
* ≥18 years old.
* HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease.
* Received palbociclib plus letrozole/aromatase inhibitor or palbociclib plus fulvestrant in line with the licenced indication(s).
* No prior or current enrolment in an interventional clinical trial for ABC/MBC.
* Minimum of three months of follow up data since palbociclib with fulvestrant initiation, or minimum of six months of follow up data since palbociclib with letrozole/aromatase inhibitor initiation (core medical record review).
* Minimum of three months of follow up data since palbociclib initiation (German interim medical record review only).
* Inoperable or recurrent breast cancer (Japan only)

Exclusion criteria:

Physician exclusion criteria

* Qualified less than 2 years ago or more than 35 years ago
* Participated in observational research for ABC/MBC in the last 3 months
* Have not prescribed either palbociclib plus fulvestrant or palbociclib plus aromatase inhibitor in line with the licenced indication(s).
Oral Versus Intravenous Antibiotics for Bone and Joint Infections (OVIVA B&J)

The study will compare the outcomes of treating bone and joint infections with 6 weeks of intravenous antibiotics with 6 weeks of oral antibiotic treatment. The trial is of antibiotic "strategy" rather than of individual antibiotics. The study will be open label, but the primary outcome will be proven failure of infection treatment, determined by pre-established objective criteria for treatment failure. The null hypothesis tested is that there will be no difference in treatment failure rates.

A long course of antibiotic therapy given by a "drip" (i.e. intravenous) is recommended treatment for many serious bacterial infections. It is costly and inconvenient for the patient to remain hospitalised for therapy, so outpatient antibiotic therapy (OPAT) programmes have been established in many countries to deliver intravenous antibiotics safely and conveniently. The majority of patients referred to OPAT programmes have bone and joint infections. However, there is no clear evidence that bone and joint infection really require long courses of intravenous antibiotics rather than oral antibiotics.

We will compare the outcome of treatment with intravenous versus oral antibiotic therapy for patients with bone and joint infection. The choice of antibiotic is complex, and antibiotics that are suitable oral choices are often not suitable intravenous choices and vice versa. Subjects will therefore be randomized to an oral or intravenous "strategy," rather than to individual antibiotics. Outcomes will be determined by pre-established objective criteria for treatment failure.

We have conducted a pilot study in one centre (Oxford), recruiting approximately 200 patients, and are now expanding to include multi-centre recruitment in the UK, aiming to recruit 1050 patients.

Eligibility Criteria:
Inclusion Criteria:

* Is willing and able to give informed consent for participation in the study. Has a bone and joint infection one of the following categories;

  1. Native osteomyelitis.
  2. Native joint septic arthritis.
  3. Diabetic foot infection with osteomyelitis.
  4. Prosthetic joint associated infection.
  5. Discitis/ spinal osteomyelitis/ epidural abscess
* Has had at least 48 hours, but not more than 7 days, of IV antibiotic therapy already given after definitive surgical management.
* Has a clinical diagnosis of bacterial infection (caused by any organism excepting mycobacteria).
* Is clinically stable in the opinion of the study clinicians, has no further interventions to treat acute infection required or planned.

Exclusion Criteria:

* Has Staph aureus bacteraemia.
* Has suspected bacterial endocarditis.
* Has suspected mediastinal infection.
* Has suspected central nervous system infection.
The Role of Mechanical Stress and Muscle Fatigue in Strength Gains

The purpose of this study is to compare the impact of different levels of mechanical stress and muscle fatigue in strength training conditions on muscle strength, muscle mass and inflammatory processes.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Knee pathology
* Systematic training