cyrilzakka/clinical-trials huggingface dataset:
Technical Assistance for Child and Adult Care Food Program in Family Child Care Home

This study evaluates the effect of a nutrition technical assistance training program for family child care home providers on the food they serve young children in their care and the food environment in their home. Half the providers will be assigned to the nutrition program and the other half will receive a comparison on environmental health.

Early care and education (ECE) providers play a vital role in ensuring that young children have access to nutritious foods. Over 25% of children in ECE (1.2 million children) attend Family Child Care Homes (FCCH). Improvements in the Child and Adult Care Food Program (CACFP) may introduce new barriers for FCCH, which have limited meal preparation capacity. Limited research has examined foods served by FCCH providers, and no group randomized trials have been conducted using a Community-Based Participatory approach in FCCH and including an evaluation of intervention costs.

Goals: 1. Determine compliance of menus and meals provided in FCCH with CACFP guidelines. 2. Determine the effectiveness of a pilot community-based Nutrition Technical Assistance intervention to enhance meeting CACFP best-practices. 3. Determine the effectiveness of a statewide community-based Nutrition Technical Assistance Intervention to enhance meeting CACFP best-practices. 4. Expand university student opportunities for participation in health research.

Methods: Conduct a cross-sectional assessment of a random sample of FCCH providers' (n=52) menus and meals served. Foods will be evaluated against the CACFP requirements and best-practices. After the cross-sectional examination, providers in the pilot will be randomly assigned to a Nutrition Technical Assistance (n=26) or attention comparison intervention (n=26). Following the pilot, trained Extension Educators will implement both interventions (n=27 intervention, n=27 comparison) in six selected counties, reaching underserved rural and low-income populations. The intervention is based on theoretical foundations and formative interviews, and will consist of two 60-90-minute visits to the FCCH and one group class lasting approximately 3 hours.

Eligibility Criteria:
Inclusion Criteria:

* Family child care home providers within 60 minutes of Oklahoma City who participate in the Child and Adults Care Food Program

Exclusion Criteria:

* none
Inhaled Salbutamol in Elective Caesarean Section

The lungs of the fetus are filled with fluid and it is essential that fetal lung fluid is cleared at birth. This process is mediated through the activation of airway epithelial sodium channels (ENaC). In animals, ENaC is considered crucial for postnatal pulmonary adaptation. In humans, postnatal ENaC expression is dependent on gestational age and its activity, measured as nasal potential difference, correlates with lung compliance. Therefore, in the human newborn infant ENaC may be important for physiologic postnatal adaptation. The activity of ENaC is increased by beta-agonists, such as salbutamol. We hypothesize that low pulmonary expression or activity of ENaC in the perinatal period causes delayed clearance of lung fluid and thereby contributes to the risk for development of transient tachypnea of the newborn (TTN) in term infants born by Caesarean section (CS).

We hypothesize that low pulmonary expression or activity of ENaC in the perinatal period causes delayed clearance of lung fluid and thereby contributes to the risk for development of transient tachypnea of the newborn (TTN) in term infants born by Caesarean section (CS). The aim of this study is to evaluate whether the respiratory status, measured by a transthoracic ultrasound method and lung compliance, of newborns infants born by CS can be improved by inhaled salbutamol at 30-60 minutes of age. 62 infants will be included and randomized to receive salbutamol or placebo-inhalations in a double-blind manner.

Eligibility Criteria:
Inclusion Criteria:

* healthy singleton pregnancy
* Cesarean section at 37 + 0 to 41 + 6 gestational weeks

Exclusion Criteria:

* clinically significant congenital malformations
* birth weight \< 2000 grams
* intubation
* 200 bp for more than 5 min
* relevant medication of the mother, e.g. albetol, beta-agonists (e.g. salbutamol, salmeterol), corticosteroids
* the suspicion of/confirmed pneumothorax or infection
Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study

This study is being done to investigate clonal hematopoiesis and therapy-emergent myeloid neoplasms in patients with ovarian or other solid cancers. Researchers want to identify risk factors for developing these blood cancers as well as if there is/are a genetic/environmental component(s) to developing blood cancer.

OUTLINE: This is an observational study.

Patients undergo blood sample collection and complete surveys on study. Patients' medical records are also reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have or have had ovarian, peritoneal, or fallopian tube carcinoma who have a life expectancy of greater than 6 months and:

  * Have completed or plan to complete at least 5 cycles of platinum-based chemotherapy

OR

* Subjects who have or have had a solid tumor diagnosis and any of the following:

  * At least 4 months of exposure to a PARP inhibitor
  * Diagnosis of a blood disorder including, but not limited to, clonal hematopoiesis of indeterminate potential, cytopenia of unknown significance, or therapy-related myeloid neoplasm

Exclusion Criteria:

* Individuals with a life expectancy of less than 6 months
A New Treatment Option for Heavy Menstrual Bleeding

Women with measured menstrual bleeding \>80ml per cycle and no contraindications to combined oral contraceptive use will be assigned to an oestradiol/nomegestrol acetate oral contraceptive for 3 cycles during which they will collect all menstrual blood and send all used sanitary protection to the laboratory at the University of Sydney for estimation of blood loss by the alkaline haematin method.

Hypothesis:

An estradiol/nomogestrel acetate (E2/NOMAC) combined pill will be effective in controlling HMB in the majority of women without structural pelvic pathology.

Main outcome:

The primary efficacy end-point will be the proportion of women with a reduction of menstrual blood loss ≥ 50% from baseline.

Women will collect menstrual blood for 3 cycles and will be eligible to enter the treatment phase if in two of the three pre-treatment cycles the measured menstrual blood loss (MBL)is \>80ml. The mean of these baseline MBL measurements will be the comparator for the efficacy treatment measurement. Iron studies (serum ferritin, Fe and transferrin) will also be measured pre and post treatment and related to women's assessment of their quality of life measured on a validated questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-50 years having regular menstrual cycles
* Women willing to collect all sanitary protection for 6 cycles
* Women with no contraindications to use of combined hormonal contraception
* Women not using any hormonal contraception or any treatment for HMB
* Women who have no demonstrable uterine pathology on pelvic ultrasound
* Women who have demonstrated a menstrual blood loss (MBL) \>80mls in 2 of 3 menstrual periods during the pre-treatment phase will be eligible to enter the treatment phase

Exclusion Criteria:

* Women for whom combined oral contraceptives are contraindicated
* Women unwilling to collect all sanitary protection for 6 cycles
* Women using hormonal contraception or any treatment for HMB
* Women who have demonstrable uterine pathology on pelvic ultrasound
* Women who have demonstrated a MBL ≤80mls in 2 of 3 consecutive menstrual periods
Copeptin and Psychological Stress of Medic During COVID-19 Pandemic

Psychological stress (PSS) is one of the most common problems among healthcare providers during COVID-19 pandemic. PSS influences the homeostatic equilibrium of the body, involving activation of the sympathetic nervous system and hypothalamus pituitary adrenal (HPA) axis. Copeptin; C-terminal portion of Vasopressin (AVP) precursor is stable. Nevertheless, Evidence about influence of PSS on copeptin levels is lacking. The reason we are doing this research is to determine the level of psychological stress among healthcare providers exposed to at the time of work in intensive care unit (ICU) during COVID-19 pandemic; They will be appraised every assembly for psychological stress level; before start of duty shifts (first time), one week after start (second time) and two weeks after departure from shift duties in ICU (third time) for assessment of psychological stress level and stress hormones.

A total of 70 healthcare personnel volunteers participated; 35 physicians and 35 nurses. All healthcare providers' volunteers are in good physical health, Exclusion criteria included hypertension, diabetes mellitus, obesity BMI ≥30, subjects with serum sodium ≤135 or ≥ 145 mmol /L at baseline or females receiving contraceptive pills.

During the research participants will answer a questionnaire as well as three blood samples are taken.

* In the first meeting, evaluation of participant general condition; determining BMI, blood pressure. Then a small amount of blood, equal to about two millimeters, will be taken from participant arm with a syringe. This blood will be tested for serum copeptin, cortisol (fasting morning sample). The investigator will ask participant few questions to evaluate the level of stress (as anxiety, insomnia, fear of infection through questionnaire)
* The second meeting, one week after work in ICU, another blood sample will be taken from participant and determine level of psychological stress.
* The third meeting, two weeks after leave from ICU participant blood sample will be taken from participant to determine stress hormones and determine level of psychological stress.

Duration

The research takes place over six months in total.

Eligibility Criteria:
Inclusion Criteria:

physicians and nurses under age of 37 years in good health

Exclusion Criteria:

* body mass index above 30
* hypertension
* Diabetes mellitus
* females receiving contraceptive pills
Asthma Control in a Dutch Primary Care Population

Rationale: Despite the availability of effective treatment to reach symptom control, nearly half of the asthma patients remain inadequately controlled. There is a need for timely and appropriate treatment of patients with uncontrolled asthma. Improving asthma control could be achieved by a better identification of causes followed by remediating modifiable factors in primary care or referral to secondary care. However, major gaps in evidence-based asthma practice exist in primary care. So far, there is a lack of knowledge on the prevalence of inadequate asthma and associated characteristics.

Objective: The primary objective is to determine the proportion of primary care patients with inadequate asthma control, as assessed during a regular control consultation with the general practice nurse.

Study design: This is a non-interventional prospective observational study, taking place in a real-world primary care setting. The AsthmaOptimiser tool will be used during regular asthma consultations in primary care, which the healthcare provider will fill in together with the patient. The AsthmaOptimiser tool creates an overview of factors and characteristics that may be associated with uncontrolled asthma, and subsequently provides a guideline-based management suggestion. Additionally, we will perform qualitative interviews to collect experiences and perspectives of healthcare providers on their use of the AsthmaOptimiser tool, including, but not limited to, ease of use, points of improvement, and on their implementation of the management suggestions.

Study population: Patients diagnosed with asthma, who attend a pre-planned primary care asthma review, are eligible to participate. A limited number of in- and exclusion criteria will be adopted, to make sure the research population closely resembles the real world.

Main study parameters/endpoints: The primary endpoint is the proportion of patients with inadequate asthma control. Inadequate asthma control will be defined as an exacerbation in the past 4 weeks and/or an ACQ6 (i.e., Asthma Control Questionnaire) score \>0.75.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years
* Physician diagnosis of Asthma
* Capacity to provide written informed consent

Exclusion Criteria:

* Life expectancy of less than 1 year
* Inability to understand Dutch
* Any other condition which, at the GPs and/or investigator's discretion, is believed to present a safety risk or may impact the study results
* Patients participating in a clinical trial that may distort outcomes in this observational study.
Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty

The study will investigate the efficacy, safety and pharmacokinetics of triptorelin 22.5 mg 6-month formulation in 44 patients suffering from central precocious puberty. The total study duration per patient will be 12 months (48 weeks).


Eligibility Criteria:
Inclusion criteria:

1. Onset of development of sex characteristics before 8 and 9 years in girls and boys, respectively (breast development in girls or testicular enlargement in boys according to the Tanner method), and candidate to receive at least 12 months of GnRH agonist therapy after study entry.
2. Aged 2-8 years inclusive (i.e. \< 9 years) for girls and 2-9 years inclusive (i.e. \< 10 years) for boys at initiation of triptorelin treatment.
3. Initiation of triptorelin treatment at the latest 18 months after onset of the first signs of precocious puberty.
4. Difference (Δ) bone age (Greulich and Pyle method) - chronological age ≥ 1 year.
5. Pubertal-type LH response 30 minutes following a GnRH agonist stimulation test before treatment initiation (leuprolide acetate 20 μg/kg SC) ≥ 6 IU/L.
6. Clinical evidence of puberty, defined as Tanner Staging ≥ 2 for breast development for girls and testicular volume ≥ 4 mL (cc) for boys.
7. Informed consent signed by one parent or both parents (as per local requirements), by the liable parent or by the legal guardian (when applicable); assent signed by the child if ≥ 7 years.

Non-inclusion criteria:

1. Gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion.
2. Non-progressing isolated premature thelarche.
3. Presence of an unstable intracranial tumour or an intracranial tumour requiring neurosurgery or cerebral irradiation. Patients with hamartomas not requiring surgery are eligible.
4. Evidence of renal (creatinine \> 2 x ULN) or hepatic impairment (bilirubin or ASAT \> 3 x ULN).
5. Any other condition or chronic illness or treatment possibly interfering with growth or other study endpoints (e.g. chronic steroid use \[except mild topical steroids\], renal failure, diabetes, moderate to severe scoliosis, previously treated intracranial tumour).
6. Prior or current therapy with a GnRH agonist, medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF 1).
7. Major medical or psychiatric illness that could interfere with study visits.
8. Diagnosis of short stature, i.e. \> 2.25 SD below the mean height for age.
9. Positive pregnancy test.
10. Known hypersensibility to any of the test materials or related compounds.
11. Use of anticoagulants (heparin and coumarin derivatives).
A Study of BGB-B3227 Alone and in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors

This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of BGB-B3227, a humanized immunoglobulin G1 (IgG1) antibody. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-B3227 as a monotherapy or in combination with tislelizumab with or without chemotherapy in participants with selected advanced or metastatic solid tumors. The study will also identify recommended dose(s) for expansion (RDFE\[s\]) of BGB-B3227 administered alone and in combination with tislelizumab.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed locally advanced or metastatic solid tumors with a high prevalence of mucin-1 (MUC1) expression
* At least 1 measurable lesion per RECIST v1.1
* Stable Eastern Cooperative Oncology Group Performance Status of ≤ 1
* Adequate organ function
* Willing to use a highly effective method of birth control

Exclusion Criteria:

* History of prior ≥ Grade 3 Cytokine Release Syndrome (CRS)
* History of severe Infusion-Related Reactions (IRRs), allergic reactions, or hypersensitivity to any ingredients or components of the study treatments
* Infection requiring systemic (oral or intravenous) therapy ≤ 14 days before the first dose of study drug(s), or participants with symptomatic COVID-19 infection
* Active leptomeningeal disease or uncontrolled, untreated brain metastasis
* Active autoimmune disease or history of autoimmune disease(s) that may relapse

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Comparison of Subtotal Stomach and Narrow Gastric Tube After Esophagectomy

Currently, both the subtotal stomach and narrow gastric tube approaches are widely used for esophagogastric anastomosis after esophagectomy. Some stud- ies have concluded that the subtotal gastric conduit is superior to the wide gastric-tube approach, as it provides better protection of the submucosal vessels and can slightly increase gastric capacity.

Furthermore, blood perfusion significantly decreases after tubular gastric surgery.

Stomach is the most common esophageal subtitute after a esophagectomy procedure, because it has a abundant blood supply and the need for only one anastomosis. However, cervical esophago-gastro anastomosis still has a high risk of complications, especially anastomosis leakage (11.9 - 25 % ).

There are three types of gastric subtitute: whole stomach, subtotal stomach and narrow gastric tube. While whole stomach and subtotal stomach has an advantage in the submucosal vascular network, a narrow tube is excellent elasticity and the ease with which it can be pulled up into the neck without tension, that could affect leakage rate.

On the other hand, after esophagectomy, nutrition status and quality of life (QoL) had decreased due to effect of adjuvant therapy, lower quantity of food intake, gastro-esophageal reflux and other postoperative syndromes. Several studies had shown the affect of the width of gastric tube to the postoperative nutrition and QoL, however, the results were not homogenous. This study aims to compared two types of gastric subtitute after esophagectomy: subtotal stomach and narrow gastric tube

Eligibility Criteria:
Inclusion Criteria:

* Pathologic finding by esophageal endoscopy: confirmed esophageal cancer.
* Indication for esophagectomy
* Age: 18 - 80 year old
* Tumor located at the middle or lower third of the esophagus
* ASA score: ≤ 3
* Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available)

Exclusion Criteria:

* Concurrent cancer or patient who was treated due to other cancer before the patient was diagnosed esophageal cancer
* Pregnant patient
* Using colon or intesinal conduit
Children With HIV and Asthma (CHIVAS)

To explore allergen-specific effector and regulatory T cell response in HIV-infected children before and after HAART initiation

Recently, US investigators have observed that HIV-infected (HIV+) children on highly active antiretroviral therapy (HAART) have a much greater cumulative incidence of asthma.Regulatory T cells may mitigate the pathogenicity of asthma through the suppression of Th2 responses. Since asthma is predominantly a TH2 mediated condition, we propose that new onset of asthma after HAART in HIV- infected children may be secondary to dysregulated immune reconstitution. The restoration of CD4+ T cell-mediated immunity in HIV+ patients treated with HAART may lead to airway inflammation, narrowing, hyperresponsiveness, and possibly remodeling.

The increased incidence of asthma in HIV-infected children treated with HAART is likely secondary to multiple factors that may include hypersensitivity to certain aeroallergens, dysregulation of effector and regulatory T cell response, as well as the imbalance of TH1 vs. TH2 cytokines. Therefore this study will identify the immunopathogenesis of increased airway hyperresponsiveness in HIV-positive patients.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged 2-18 years
2. Parent signed inform consent and children signed assent form
3. Children who are starting highly active antiretroviral therapy (HAART) due to clinical indication or switching HAART due to treatment failure within 45 days after screening visit

Exclusion Criteria:

1. Pregnancy
2. History of chronic lung disease including lymphoid interstitial pneumonitis (LIP), and bronchopulmonary dysplasia (BPD).
3. Active opportunistic infections i.e. pulmonary tuberculosis, PCP, pneumonia
4. Conditions limiting ability of subject to comprehend questionnaires (i.e. mental retardation).
Factors Predicting Blood Pressure Change With Interscalene Block

The primary aim of this study is to identify potential anthropometric features that predict the relationship between the Interscalene Block procedure and changes in blood pressure

This prospective, randomized study will be carried out after obtaining the necessary ethical approval and informed consent from the patients. 110 adult volunteer patients who will undergo ISB for shoulder surgery anesthesia will be included in this study. Evaluation of the patients before ISB and anthropometric measurements before and after Interscalene Block will be performed by an anesthesiologist who is not involved in the study.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III, elective shoulder surgery will be performed

Exclusion Criteria:

* Presence of advanced renal or hepatic insufficiency, serious respiratory or cardiovascular disease
* History of chronic opioid or benzodiazepine use
* Presence of allergy to the local anesthetic drugs used
* ISB contraindication (such as neurological disorder in the extremity to be operated on, diaphragmatic paralysis in the opposite region of the side where the intervention is planned, infection in the intervention area).
* Presence of high level anxiety
* Patients with a Hospital Anxiety and Depression Scale (HADS) cut-off score of 10 for the anxiety subscale and 7 or higher for the depression subscale
Manual Therapy, Exercise and Traction for Patients With Cervical Radiculopathy: A RCT

To date, optimal strategies for the management of patients with Cervical Radiculopathy (CR) remain elusive. The purpose of this study was to compare the effects of manual therapy, exercise, and cervical traction to manual therapy, exercise, and sham traction on pain, function and disability in patients with CR.


Eligibility Criteria:
Inclusion Criteria:

* 3 of 4 positive on CPR, 18-70yrs

Exclusion Criteria:

* history of previous cervical or thoracic spine surgery
* bilateral upper extremity symptoms
* signs or symptoms of UMN disease
* medical "red flags"(tumor, fracture, rheumatoid arthritis, osteoporosis, prolonged steroid use)
* cervical spine injections (steroidal) in the past two weeks
* current use of steroidal medication prescribed for their radiculopathy symptoms