cyrilzakka/clinical-trials huggingface dataset:
The Bottle Study: Infant Weight Gain During Use of Novel Versus Typical Infant Feeding Bottles

The purpose of this study is to pilot test whether a novel infant feeding bottle changes how much formula an infant drinks and how quickly he/she drinks it, as compared to meals provided in a standard bottle. Exclusively formula-fed infants and their caregiver will be provided with the novel feeding bottle and caregivers will be asked to acclimate their infant to this bottle during the next several weeks. Once acclimated, infants will undergo two weighed, timed, and videotaped test meals on two separate days; one with the novel bottle and one with their standard bottle, in random order. It is hypothesized that when the novel bottle is used, infants bottle will consume smaller meals and will have a longer meal duration, as compared to when a standard bottle is used.


Eligibility Criteria:
Inclusion Criteria:

* healthy, exclusively formula-fed infants aged 1-6 months at enrollment;
* parent must be at least 19 years of age, able to understand written and verbal English, and provide daytime care for the infant at least 4 days per week.

Exclusion Criteria:

* born \< 37 weeks;
* birth weight \< 2500g or \> 4000g;
* current weight \< 10th percentile for age;
* hospitalization \> 72 hours following birth or any hospital admission since birth;
* any health issue that could interfere with feeding and/or growth;
* use of complementary foods;
* inability or unwillingness to comply with study-related procedures.
TumorGraft- Guided Therapy for Improved Outcomes in Head and Neck Squamous Cell Cancer- A Feasibility Study

Primary objectives:

1. Evaluate the feasibility of rapidly accruing 30 participants with recurrent metastatic head and neck squamous cell carcinoma for the development of patient derived xenographs (PDX) from fresh, real time biopsies in which sensitivity to \< 4 Ontario funded chemotherapeutic regimen will be tested. Written feedback to the primary oncologist will be provided.
2. There is also a curative intent cohort of 30 participants undergoing surgical resection with curative intent. These PDX models will undergo exome sequencing with written feedback.
3. Feasibility in both surgical and recurrent cohorts will be a measure of i) engraftment rate, ii) patient status at the time of drug testing completion and iii) rate of accrual.

Tumour samples from 30 participants with HNSCC that undergone curative surgery will be used to establish patient-derived xenografts (PDXs). These tumours will also undergo exome sequencing. This will provide a biobank of PDX models with available genomic information for future research projects. Another 30 participants with recurrent or metastatic HNSCC (RMHNSCC) will be recruited to this study. PDX models will be developed from these patient tumours, followed by genomic sequencing. PDX models are developed by transplanting small tumour pieces into immunocompromised mice. These mice are then treated with different available drugs for RMHNSCC at the discretion of their medical oncologist. These mice will be then followed up to examine the tumour response to treatments. When studied in clinic, PDX models have shown high correlation with patient response to the treatment. The PDX drug testing results will be provided to the treating medical oncologist to guide care at the oncologists discretion. Investigators' hope is that improved chemotherapy responses are observed with this strategy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with recurrent metastatic squamous cell carcinoma of the head and neck.
2. Lesion amenable to biopsy (1 cm or more)
3. Lesion capable of yielding 4 biopsy cores
4. 18 years or older
5. Capable of providing and signing for informed consent

Exclusion Criteria:

1. Cognitive impairment prohibitive to providing informed consent
2. Pregnant or lactating women.
MEDA Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation for Stage IV Natural Killer/T-cell Lymphoma

The purpose of this study is to evaluate the efficacy and safety of methotrexate, etoposide, pegaspargase and dexamethasone (MEDA) chemotherapy and autologous hematopoietic stem cell transplantation (Auto-HSCT) in patients with stage IV extranodal natural killer/T-cell lymphoma, nasal type.

Extranodal natural killer/T-cell lymphoma (ENKTCL), nasal type, is a rare subtype of non-Hodgkin lymphoma (NHL) with relatively high incidence in China. L-asparaginase based chemotherapy improved overall response and prolonged the long-term survival for patients with stage IV. But the optimal treatment schedule has not been established. This study is designed with four cycles MEDA chemotherapy, followed by Auto-HSCT for stage IV patients with newly onset, relapsed or refractory diseases. The efficacy and safety of this protocol in the treatment of will be measured.

Eligibility Criteria:
Inclusion Criteria:

Pathological diagnosis of extranodal natural killer/T-cell lymphoma, nasal type based on WHO 2008 classification of tumors of haematopoietic and lymphoid tissue.

Eastern Cooperative Oncology Group (ECOG ) performance status 0\~3.

Stage IV disease with at least one measurable lesion.

Preserved organ functions for: Platelet\>50×10\*9/L, hemoglobin\>80g/L, total bilirubin (TBIL)\<3×ULN, alanine transaminase (ALT)\<5×ULN, serum creatinine (Cr)\<1.5×ULN, fibrinogen≥0.5g/L, LVEF≥50%.

Signed Informed consented.

Exclusion Criteria:

Relapsed or progressive disease to prior L-asparaginase-based chemotherapy.

Concurrent cancers need surgery or chemotherapy within 6 months.

History of chemotherapy or radiotherapy for other solid cancers within 3 years.

Recent history of radiotherapy of upper-aero-digestive tract within last 3 months.

Significant complications: LVEF≤50%, coagulopathy, autoimmune disease, severe infection, or liver cirrhosis, severe hemophagocytic lymphohistiocytosis.

Mental disorders.

Pregnant or lactation.

HIV, hepatitis virus C (HCV), or active hepatitis virus B (HBV) infection with HBV DNA≥10\*5 copies/ml.

History of pancreatitis.

Known history for grade 3/4 allergy to the drugs in chemotherapy regimen.

Enrolled in other trial treatment.
Reconstitution of a Human Immune System in a Patient Derived Xenograft (PDX) Model of Genitourinary (GU) Cancers

The objective of this study is to obtain human blood CD34+ hematopoietic stem/progenitor cells (HSPCs) to reconstitute a match human immune system in our PDX model. The hypothesis is that by using matched leukocytes and PDX from the same patient, rejection of the PDX by the host immune system will not be observed and therefore a preclinical model to study immunotherapy can be developed to study, understand and improve upon our current therapies. HSPCs will be collected from bone marrow aspirate obtained from a bone marrow biopsy.

The secondary objective is to use patient tumor biopsy samples or circulating tumor cell samples to develop additional preclinical models of GU cancers, particularly prostate cancer, that are clinically relevant by generating additional PDXs.


Eligibility Criteria:
Inclusion Criteria for Bone Marrow Biopsy:

1. Patients with Genitourinary (GU) Cancers and presence of existing patient derived xenograft or planned collection of tumor for PDX generation
2. Age ≥ 18 years.
3. Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines.
4. Ability to undergo bone marrow biopsy
5. Laboratory requirements (Hematocrit 30%, Platelets 75,000 + 10\^6/l and WBC 4000 X 10\^6/l)
6. Karnofsky performance status \>70%

Exclusion Criteria for Bone Marrow Biopsy:

1. Participants with serious concurrent chronic or acute illness that would affect the safety of a bone marrow biopsy.

Inclusion Criteria for Tumor Biopsy

1. Patients with prostate cancer

   a. Biopsies in this study for diseases other than prostate cancer are not permitted.
2. Age ≥ 18 years.
3. Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines.
4. Planned or willing to undergo a tumor biopsy. Biopsies may be for research or clinical purposes depending on the treating provider for men with prostate cancer. Biopsies in this study for diseases other than prostate cancer are not permitted

   1. For research only biopsies: At least one lymph node or bone metastatic amenable to a minimum risk biopsy in the opinion of the treating physician.
   2. For clinical purpose biopsies: There are no location or risk requirements.
5. Laboratory requirements (Hematocrit 30%, Platelets 75,000 X 10\^6/l and WBC 4000 X 10\^6/l)
6. Karnofsky performance status \>70%

Exclusion Criteria for Tumor Biopsy:

1. Participants with serious concurrent chronic or acute illness that would affect the safety of a tumor biopsy.
Acute Heart Failure With Reduced Ejection Fraction - COngestion Discharge Evaluation

The AHF-CODE reduced study is a prospective, non-randomized, monocenter study performed in patients with heart failure with reduced ejection fraction admitted for worsening heart failure.

The main objective of the AHF-CODE study is to identify congestion markers (clinical, biological and ultrasound) at the end of hospitalization for acute heart failure that are associated with the risk of all cause death or rehospitalization for acute heart failure within 3 months of hospital discharge.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalised for acute heart failure.
* Patients with reduced ejection fraction (Ejection Fraction \<40%) or (40% ≤ Ejection Fraction \< 50)
* Patients considered clinically discharging from hospitalisation for acute heart failure.
* Age ≥18 years
* Patients having received complete information regarding the study design and having signed their informed consent form.
* Patient affiliated to or beneficiary of a social security scheme.

Exclusion Criteria:

* Comorbidity for which the life expectancy is ≤ 3 months
* Dialysis patient (peritoneal dialysis or hemodialysis) or patients with glomerular filtration rate \<15 ml/min/m2 at inclusion.
* History of lobectomy or pneumonectomy lung surgery
* Severe pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis, etc.
* Pregnant woman, parturient or nursing mother
* Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice) Adult person who is unable to give consent
* Person deprived of liberty by a judicial or administrative decision,
* Person subject to psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 of the Public Health Code.
Evaluation of a Self-Care Toolkit in Surgical Breast Cancer Patients

This randomized controlled trial (RCT) in newly-diagnosed breast cancer patients seeks to determine the effectiveness of a self-care toolkit on specific symptoms associated with surgery as compared to a standard care group.

The main research questions focus on whether the toolkit provides short-term benefits on symptoms associated with surgery (i.e., pain, anxiety, nausea) and whether it impacts emotional distress and other symptoms (i.e., pain, fatigue, sleep disturbance, global health, quality of life) at a two-week post-operative time point. This study will be conducted at San Antonio Military Medical Center (SAMMC) in active duty, veteran, and military dependent women newly diagnosed with breast cancer for whom surgery (e.g., lumpectomy or mastectomy) is the initial treatment option. One to two weeks prior to surgery, women diagnosed with breast cancer at SAMMC Oncology Department will be invited to participate in this study. Those who meet criteria and agree to participate will be enrolled on-study and randomly assigned to either the surgical toolkit group or standard care group. During the pre-operative period, women in the intervention group will be asked to read through the manual, listen to each of the 8 audiofiles at least once but as many times as desired, and to wear the acupressure wristbands during surgery. Women randomized to the standard care group will not receive an intervention prior to surgery but will receive the toolkit at study completion. The rationale for providing women in the standard care group with the toolkit at their post-operative visit is that the skills of breathing, meditation, and guided imagery might be potentially beneficial for them to use during their subsequent treatment or a future surgery. Additionally, qualitative interviews will be conducted in a cohort of women from the intervention group, at a two-week post-operative time point to assess their impressions and satisfaction with the toolkit; questions will focus on whether the individual used each of the toolkit's components, frequency of use, how she would rate the product's attributes (e.g., ease of use, clarity of instructions, quality rating, helpfulness), and perceptions about the helpfulness and usefulness of learned mind-body skills.

Eligibility Criteria:
Inclusion Criteria:

* 18+ years of age
* Women treated at SAMMC Oncology clinic or CRDAMC Oncology clinic for newly-diagnosed breast cancer for whom surgery (e.g., lumpectomy or mastectomy) is the initial treatment option

Exclusion Criteria:

* Women receiving chemotherapy, radiation or hormone therapy as first line treatment for breast cancer (i.e., any of these treatment options prior to surgery)
* Severe hearing-impairment (i.e., that would interfere with ability to hear the toolkit audiofiles)
Longitudinal Well-Being Study

The goal of this clinical trial is to evaluate the effectiveness of the Flourish app-a digital toolkit providing science-based well-being practices-in enhancing mental health among students. The main questions it aims to answer are:

* Does regular use of the Flourish app improve well-being, emotional resilience, and stress management?
* Is more frequent use of the Flourish app associated with greater improvements in these outcomes?

Researchers will compare outcomes between participants using the Flourish app and a control group receiving curated national mental health resources to assess the app's impact.

Participants will:

* Complete an initial 15-minute survey to establish baseline mental health
* Those in the Flourish app condition will use the app at least twice weekly, while those in the control condition will receive weekly mental health resources and reflect on their application
* Complete biweekly follow-up surveys over six weeks, with a final survey three months later


Eligibility Criteria:
Inclusion Criteria:

* Currently a student
* Fluent in English
* No uncontrolled mental health condition that significantly impacts daily life
* Prolific approval rate within the 95-100% range
* Minimum of 20 previous Prolific submissions
Impact of Feeding on Pro-Inflammatory Cytokine Response in Neonates Receiving a RBC Transfusion

Prior to a non-urgent blood transfusion, subjects will be randomized to either stopping feeds or continuing feeds. The intervention group will be the placement of a subject in the NPO group. Subjects in the intervention group will have their feedings stopped for a total of 24 hours around the time of the PRBC transfusion. These infants will be given intravenous nutrition during the period of time that they will not be fed. During the transfusion, both groups of subjects will have serum cytokine levels obtained at 3 time intervals- 1) 4 hours pre-transfusion, 2) 2-4 hours post-transfusion, and 3) 20-24 hours post-transfusion.

Recently many publications have indicated a potential temporal association between packed red blood cell (PRBC) transfusion and the development of NEC in neonates. Although, to date, there is no conclusive evidence indicating a causal role of PRBC transfusion on the development of NEC. Given the growing body of data that support the association of PRBC transfusions and NEC, a common clinical dilemma arises with regard to feeding infants during a blood transfusion. Additionally, it is thought that increased immunomodulation may be exacerbated by any other pro-inflammatory process or insult; thereby leading to a rapidly increasing cascade of pro-inflammatory cytokines which may ultimately lead to gut inflammation and NEC.

Prior to a non-urgent PRBC transfusion, subjects will be randomized to either the NPO group or fed group of patients. The intervention will be the placement of a subject in the NPO group. Subjects will be made NPO for a total of 24 hours around the time of the PRBC transfusion. During the transfusion, both groups of subjects will have serum cytokine levels obtained at 3 time intervals- 1) 4 hours pre-transfusion, 2) 2-4 hours post-transfusion, and 3) 20-24 hours post-transfusion.

Eligibility Criteria:
Inclusion Criteria:

* Infants born \< 31 weeks gestational age
* Between 3 and 7 days old at time of consent

Exclusion Criteria:

* Infants with multiple congenital anomalies
* Infant with suspected/confirmed genetic anomalies
* Infant with suspected/confirmed congenital immune deficiencies
The Use of Platelet-rich-fibrin in Lower Third Molar Surgery.

The present study aims to analyze the effect of PRF (Platelet-rich-fibrin) in terms of facial swelling, trismus and pain after surgical removal of mandibular third molar (M3M) in a split-mouth randomized controlled clinical trial.

The present study aims to analyze the effect of PRF (Platelet-rich-fibrin) in terms of facial swelling, trismus and pain after surgical removal of mandibular third molar (M3M) in a split-mouth randomized controlled clinical trial. Facial swelling will be assessed using an innovative three-dimensional digital technique.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 32 years who required both M3M extractions were recruited
* Good health status
* Indication to surgical extraction of both M3M
* Complete root formation
* Surgical risk level classified as "Conventional" or "Moderate" according to Daugela et al. classification

Exclusion Criteria:

* Person under the age of 18 or over 32
* Allergy or contraindications to administration of corticosteroids
* Acute infection in any of the teeth to be extracted
* Patients with chronic liver disease, diabetes, immune system dysfunction, or haematological disease
* Pregnancy or breastfeeding
* History of treatment with antiresorptive drugs
* Chronic kidney disease
The Effect of Square Stepping Exercises Training on Lower Extremity

Physical activity plays an indispensable role to lead a healthy life. Square-stepping exercises (SSE) are aerobic exercises.Our study was designed to investigate the effects of square-stepping exercise training on lower-extremity motor performance, muscle strength, and muscle quality of sedentary healthy young individuals.

A total of 120 volunteers within the age range of 20-25 participated in the research. Participants were randomly divided into two groups, as 60 participants were study group (35 females, 25 males) and 60 participants were control group (35 females, 25 males). Demographic data and exercise habit of the individuals were documented. Participants' lower-extremity motor performance was analyzed through Vertical Jumping, Side Jumping, One Leg Squat, and Step-Up tests. Participants' muscle strength was analyzed through Hand-Held Dynamometer. Also, participants' muscle quality was analyzed through Muscle Quality Index. Throughout 3 weeks SSE training was administered 4 days a week for a length of 45 minutes in each session. All the analyses were conducted at the start and at the end of 3-week long training

Eligibility Criteria:
Inclusion Criteria:

* 20-25 years old,
* Not attending any exercise program for the last 1 year,
* Not having a neurological, orthopedic disease or any disease affecting lower extremity,
* Not having any lower-extremity surgery,
* Individuals without vision and/or hearing problems were included in the study.

Exclusion Criteria:

* Having a vision and/or hearing problem,
* Having neurological, psychiatric, and/or orthopedic problems that affect walking,
* Individuals with lower-extremity surgery were excluded from the study.
Cardiovascular Risk Profile in Patients With Congenital Adrenal Hyperplasia

Treatment with glucocorticoids and mineralocorticoids has changed congenital adrenal hyperplasia (CAH) from a fatal to a chronic lifelong disease. Long-term treatment, in particular the chronic (over-)treatment with glucocorticoids, may have an adverse effect on the cardiovascular risk profile in adult CAH patients. The objective of this study was to evaluate the cardiovascular risk profile of adult CAH patients.

Treatment with glucocorticoids and mineralocorticoids has changed congenital adrenal hyperplasia (CAH) from a fatal to a chronic lifelong disease. Long-term treatment, in particular the chronic (over-)treatment with glucocorticoids, may have an adverse effect on the cardiovascular risk profile in adult CAH patients. The objective of this study was to evaluate the cardiovascular risk profile of adult CAH patients.

DESIGN: Case control study Primary objective : detection of cardiovascular damage in patients with classical or non classical CAH diagnosed in childhood. The patients will be compared with age- and gender- and tobacco status- matched control.

Secondary objective Study of microvascular function Evaluation of cardiovascular risk factors Total cumulative (TCG) and total average (TAG) glucocorticoid doses will be calculated from pediatric and adult files and correlated to arterial macro- and microcirculatory dysfunction.

Primary outcome Ultrasound evaluation of intima-media thickness at common carotids, carotid bulbs and left ventricular function Secondary outcome Peripheral and central blood pressure Skin capillary density and pulse-wave velocity Glucose and insulin during an oral glucose tolerance test Circulating cardiovascular risk markers (hsCRP, adiponectin, Interleukin-6) Lipid profile Anthropometry, fat and lean mass measured by dual-energy X-ray absorptiometry Total cumulative dose of glucocorticoid Number of subjects : 90 patients/90 controls Inclusion criteria of CAH patients

* Patients \> 18 yrs with classical or non classical CAH diagnosed during childhood
* Absence of known cardiovascular disease
* Absence of combined oral contraceptives during the previous month Inclusion criteria of controls
* Age under 18
* Absence of known cardiovascular disease
* Absence of combined oral contraceptives during the previous month

Duration of the inclusion period: 3 years

Eligibility Criteria:
Inclusion criteria : patients

* Patients \> 18 yrs with classical or non classical CAH diagnosed during childhood
* Absence of known cardiovascular disease
* Absence of combined oral contraceptives during the previous month

Inclusion criteria : controls

* Age \> 18 yrs
* Absence of known cardiovascular disease
* Absence of combined oral contraceptives during the previous month

Exclusion criteria :

* Blood donation during the previous 3 months
* Cardiovascular disease
* Treatment by combined oral contraceptives
* Pregnancy