cyrilzakka/clinical-trials huggingface dataset:
The Resilience Clinic Evaluation

Early life adversity can affect children's physical and mental health. The Resilience Clinic is a support program for young children and their caregivers who have been exposed to significant adversity, aiming to prevent the harmful effects of stress and improve child health, behavior, and development while also reducing caregiver stress. This study seeks to evaluate the Resilience Clinic, assessing the intervention's impact on child health, behavior, and development and caregiver stress and mental health.

Early-life trauma and related adversities are prevalent and associated with negative health, developmental, and behavioral outcomes in children. Research to design and test practical, scalable healthcare interventions that mitigate toxic stress is needed to promote improved health and developmental outcomes in children.

The Resilience Clinic is an interactive, caregiver-child psychoeducational intervention for parents and other adult caregivers of young children (ages 0-5 years) with exposure to traumatic events or other significant adversity. The aim of this primary-care based intervention is to prevent or mitigate the toxic stress response, thus promoting child resilience in the face of adversity, with the goal of improving child health, behavioral, and developmental outcomes.

The overall aim of this study is to evaluate the the efficacy and operational feasibility of the revised Resilience Clinic (RC). This is a non-randomized clinical trial comparing intervention caregiver-child dyads to a prospective control group drawn from a concurrent clinical trial (NCT05259436, The Collaborative Approach to Examining Adversity and Building Resilience Study (CARE), PI Thakur). In the intervention group, we will conduct pre-post intervention comparisons along with comparisons between the intervention group and the control group drawn from the CARE study. A subgroup analysis will compare two intervention arms (clinic based vs community-based intervention) to each other and the control condition. This clinical trial is supplemented by a mixed-methods quality improvement (QI) tools, including process measures (attendance and billing/claims data) to evaluate operational and financial feasibility; participant surveys/interviews/focus groups to assess acceptability; and analysis of quality improvement meeting notes.

Eligibility Criteria:
Inclusion Criteria:

* Caregiver: 18 years old and older, primary caregiver, English or Spanish speaking
* Child: 2 to 5 years, PEARLS score \> 1 or verbal disclosure of PEARLS adversity to primary care clinician/staff

Exclusion Criteria:

* Caregiver: active suicidality, other psychiatric issues
* Child: significant medical co-morbidities (i.e. disease requiring immunomodulators, chemo or radiation therapy, or hormonal therapy)
Impact of Opioid Free Anesthesia on Outcome After Hip Arthroplasty by Direct Anterior Approach.

all patients with a first anterior arthroplasty, give their informed consent to be randomized to control or study protocol.

control means no high steroid dose, opioids for anesthesia; paracetamol, NSAIDs and opioids as analgesia.

study protocol means methylprednisolone 125 mg and opioid free anesthesia followed by paracetamol, NSAIDs and if needed opioids as escape.

study group means for Anesthesia:

1. High dose corticoids pre-operative: 125 mg Methylprednisolone. (Medrol) pre incision and 24h postoperative
2. OFA using a multimodal approach including alpha2agonists, lidocaine and low dose ketamine (max 1mg/kg).
3. Avoid opioids post-operative by using multimodal non-opioid analgesics after OFA. Avoid epidural to allow rapid mobilization.

all patients get Tranexamic acid 1 g (2 amp Exacyl 500mg) before and 1 g after surgery. It act as antifibrinolytic to reduce postoperative bleeding. (reversibly binding to lysine receptor sites on plasminogen) Try to give Continuous deep neuromuscular block (NMB) with a post titanic count (PTC) \< 3 by continuous infusion and monitoring of NMB.

Intravenous Fluid restrictions to 1 ml/kg/h as long as pulse pressure (or plethysmograph) variation \< 20% to reduce wound edema.

The pericapsular injections of local anesthetic, provided the patient had no contraindications such as poor renal function or allergies. 100 ml Ropivacaine 0,2% (max dose 3 mg/kg) + additives (Adrenaline 2,5 cc) (Ropivacaine: max 3 mg/kg)

Eligibility Criteria:
Inclusion Criteria:

* arthroplasty by anterior approach

Exclusion Criteria:

* allergy or impossible to use any of the drugs included
* revision procedure
* major cardiovascular, pulmonary or renal insufficiency requiring planned post operative intensive care admission
A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)

IMPAHCT: Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial is a Phase 2b/Phase 3 study to evaluate the safety and efficacy of AV-101 (dry powder inhaled imatinib) in patients with Pulmonary Arterial Hypertension (PAH). The Phase 2b part of the study will assess three doses to establish an optimal dose for the Phase 3 part of the study. The Phase 2b primary endpoint will be the placebo corrected change in pulmonary vascular resistance (PVR). The Phase 3 primary endpoint will be the placebo corrected change in 6-minute walk distance (6MWD) after 24 weeks of treatment.


Eligibility Criteria:
Key Inclusion Criteria

* PAH belonging to one of the subgroups:

  1. I/HPAH, PAH-CTD,
  2. PAH due to drugs and/or toxins/chemicals (having been in the care of the investigator for at least one year with no relapses of drug or toxin/chemical abuse),
  3. HIV associated or
  4. PAH due to repaired congenital heart disease (at least 1 year since repair)
* World Health Organization (WHO) Functional Class II, III or IV symptoms
* Stable concomitant background therapy of at least one PAH approved medications
* Able to walk a distance of at least 100 m but no more than 475 m during the Screening 6-minute walk tests.

Key Exclusion Criteria

* Pulmonary hypertension (PH) belonging to Groups 2 to 5
* A history of left-sided heart disease
* Pregnant or breast-feeding females

Additional criteria may apply, per protocol
Study of the Safety and Effectiveness of Rilonacept (IL-1 Trap) Administered Subcutaneously in Subjects With Non Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) and Anemia

Anemia of inflammation is a common complication in patients with chronic kidney disease (CKD). Patients with CKD and anemia of inflammation also exhibit decreased response to erythropoietic agents, even in the presence of adequate iron stores. This decreased responsiveness is associated with increased levels of proinflammatory cytokines. Rilonacept is being developed for the treatment of inflammatory disorders.

This is a clinical research study to determine the safety and effectiveness of rilonacept for the treatment of anemia in inflamed patients with CKD who are not yet on dialysis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female greater than 18 years of age
* Chronic Kidney Disease (CKD) not yet requiring renal replacement therapy (pre-dialysis patients)
* Not expected to require dialysis during duration of the study
* Adequate laboratory values
* If on rHuEPO therapy, the dose must be stable

Exclusion Criteria:

* Persistent chronic or active infections
* Intravenous (IV) iron administration within 12 weeks prior to the Screening Visit
* Known history of severe uncontrolled hyperparathyroidism
* Prior recipient or scheduled to receive a kidney transplant during the study
* Abnormal laboratory values
* Unstable angina or myocardial infarction within the past 6 months prior to the Screening Visit
* Uncontrolled hypertension
* Coronary disease diagnosed in the 3 months prior to the Screening Visit
* Severe Congestive Heart Failure
* History of HIV
* Hepatitis B and/or Hepatitis C
* Abnormal chest radiograph
* A positive intradermal skin tuberculin test
* History or presence of cancer within 5 years of the Screening Visit
* History of alcohol abuse or current intake of 21 or more alcohol-containing drinks per week
* History of drug abuse within the 5 years prior to the Screening Visit
* Lactating females or pregnant females
The Physiological Consequence of Silicone-hydrogel Care-solution Bio-incompatibility

The purpose of this study is to more objectively evaluate potential lens-material/care solution bio-incompatibilities. We will do this by measuring corneal staining and the amount of fluorescein dye diffusion into the eye.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age.
* Best correctable vision to 20/40 in each eye.
* Possess a functional spectacle prescription to allow adequate vision during the de-adaptation and fluorometry measurement period.
* No known ocular or systemic allergies, which may interfere with contact lens wear.
* No known systemic disease, or need for medication that may interfere with contact les wear (i.e. antihistamines, beta-blockers, steroids, ect.).

Exclusion Criteria:

* Subjects demonstrating any medical condition that may affect the results of this study SHOULD NOT be enrolled. The following are specific conditions that exclude subjects from enrollment in this study.
* Eye (ocular) or systemic allergies that may interfere with contact lens wear.
* Clinically significant corneal swelling (greater than 3 or 4 on a 0-4 scale), corneal blood vessel growth (vascularization), corneal staining, bulbar redness, tarsal redness, or any other abnormality of the cornea that may cause unsafe contact lens wear.
* Are taking part in any other study or have taken part in a study within the last 14 days.
* Are pregnant, or anticipating to become pregnant during the course of the study.
Oral Estradiol Valerate Versus Oral Contraceptive Pill in Invitro Fertilization Patients

The recent controversy regarding the use of pill for cycle planning in GnRH antagonists IVF cycle has driven the search for new ways to plan IVF cycles in order to avoid weekends or to equally distribute the workload. Recently, mid-late luteal phase oral estrogens seem to be as good as the pill. The investigators will compare OCP vs oral estrogens to plan the initiation of IVF cycles.


Eligibility Criteria:
Inclusion Criteria:

* 1st or 2nd IVF cycle
* BMI \<30 kg/m2
* regular menstrual cycles
* basal FSH \<10IU and E2 \<60pg/mL

Exclusion Criteria:

* polycystic ovaries
* endometriosis
* previous ovarian surgery
* previous low ovarian response
Study Of The Efficacy And Safety Of SU-014813 In Patients With Metastatic Breast Cancer

To determine the antitumor efficacy and the safety of SU-014813 at a dose of 100 mg orally once daily in patients with Metastatic Breast Cancer


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven diagnosis of metastatic breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent.
* Must have received prior treatment with an anthracycline and a taxane either concurrently or sequentially in the adjuvant and/or advanced disease treatment settings. Patients may have received as many as 2 other chemotherapy regimens in the advanced disease setting. Patients whose tumors are Her-2-positive must have received prior trastuzumab therapy. Prior hormonal therapy or immunotherapy in the adjuvant and/or advanced/metastatic disease settings is permitted. Prior treatment with surgery, radiotherapy, chemoembolization therapy, or cryotherapy is allowed if these therapies did not affect the areas of measurable disease.

Exclusion Criteria:

* Prior treatment with \>/= 3 regimens of chemotherapy in the metastatic disease setting beyond those containing anthracyclines and taxanes
* Uncontrolled brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. Patients should have completed surgery or radiation therapy for existing brain metastases, should not have documented increase in size over the previous 3 months and should be asymptomatic
Gluteal Squeeze for Left Colon Distension

Good distension of the colon during colonoscopy is essential to detect polyps. Gas sometimes escapes the colon through the anus resulting in compromised distension. Pressure on gluteal muscles when the colonoscope tip is in the left colon might help preventing this and thus increase visibility. No previous study looked at this.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 40 years
2. Scheduled colonoscopy

Exclusion Criteria:

1. Inflammatory bowel disease
2. History of colorectal cancer or colon resection
3. Any colorectal cancer syndromes (FAP, HNPCC, SPS)
4. Patient with poor bowel preparation identified during insertion
Muscle Energy Technique Versus Mulligan Mobilization on Forward Head Posture

sixty patients with forward head posture will be randomized to three groups Group A: will receive traditional treatment ( isometric exercise for deep neck flexors plus sub occipital release).

Group B: will receive traditional treatment plus muscle energy technique for upper trapezius, elevator scapulae and sternocleidomastoid.

Group C: will receive traditional treatment plus mulligan mobilization


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 45 years
* Non specific neck pain reproduced by neck movement
* Neck pain at least within the last three months
* Limitation in cervical range of motion

Exclusion Criteria:

* cervical spine surgery or injury
* neurologic deficits, infection or inflammation
* cervicogenic headache
Prospective, Randomized Study Evaluating The Efficacy of Chlorhexidine Gluconate Impregnated No-Rinse Cloths.

Subjects in the study were randomized to a treatment group using Chlorhexidine cloths or a standard-of-care group who only had a bath with antibacterial soap and water. Both groups received standard infection control practices during admission.

Between March 2012 and November 2012, patients scheduled for total hip arthroplasty (THA) or total knee arthroplasty (TKA) were randomized (539 patients; 554 arthroplasties) at the time of their preoperative clinic visit. Patients in the chlorhexidine protocol group (275 arthroplasties) applied 2% chlorhexidine gluconate-impregnated cloths to their skin the night before and the morning of surgical admission. Patients in the standard of care group (279 arthroplasties) took a bath with soap and water the night before surgical admission. Both groups were subject to standard infection control practices during admission. The primary outcome was periprosthetic infection incidence within one year of surgery, and secondary outcomes included the potential influence of risk factors for periprosthetic infection and incidence of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Joint replacement surgery for any reason
* 18 years or older

Exclusion Criteria:

* unable to comply with study requirements
* were pregnant
* were under the age of 18 years
* medical history of immunosuppression or systemic disease e.g. human immunodeficiency virus, status-post organ transplantation
* received greater than 10 milligrams of prednisone equivalent for more than 10 days within 90 days prior to enrollment;
* chronic hepatitis B or C infection
* had an infection in or around the joint requiring surgery.
The Relationship Between Functional Exercise Capacity, Respiratory Muscle Strength, Trunk Control, Balance and Activities of Daily Living in Individuals With Cerebral Palsi

Cerebral palsy (CP) causes problems in posture, movement, breathing, postural control and balance in individuals. This work; This study was conducted to examine the relationship between functional exercise capacity, respiratory muscle strength, trunk control, balance and activities of daily living in individuals with spastic cerebral palsy.

Cerebral palsy (CP) causes problems in posture, movement, breathing, postural control and balance in individuals. This work; This study was conducted to examine the relationship between functional exercise capacity, respiratory muscle strength, trunk control, balance and activities of daily living in individuals with spastic cerebral palsy.

23 children with spastic type CP and 22 typically developing children aged 6-18 years were included in the study. After recording the demographic data, the trunk control "Trunk control measurement scale" (TCMS), the activities of daily living "Pediatric Disability Assessment Inventory" (PDI), the balance "Pediatric Berg Balance Scale" (PBDI), functional exercise capacity "2 Minute Walking Test" and respiratory muscle strength was evaluated with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) measurements. Compared to individuals with typical development, individuals with CP had lower TCMS, PPI, PBRS, 2-minute walking test and respiratory muscle strength values (p\<0.01). At the same time, it was observed that individuals with hemiparetic CP had better TCMS, PPI, PBRS scores, functional exercise capacities and respiratory muscle strength compared to individuals with diparetic disease and individuals with CP at GMFCS I level compared to individuals with other levels. It was found that there was a high correlation between trunk control, balance and functional capacity of individuals with CP. It was concluded that the influence on trunk control affects balance and functional capacity. There was also a correlation between the scales.

Eligibility Criteria:
Inclusion Criteria:

* Being between 6-18 years old,
* Having been diagnosed with spastic hemiplegic or spastic diplegic cerebral palsy,
* No communication problem,
* GMFCS level was determined to be between I-III.

Exclusion Criteria:

* The parent who will answer the form does not know Turkish,
* Orthopedic surgical treatment and botulinum toxin injection in the 6 months before the study,
* It was determined as having other orthopedic, neurological and cardiopulmonary diseases that may affect balance and gait.
Disjunction Between Patient Narrative and Formulaic Thinking in the Doctor

This study is seeking whether giving or not giving a clinician a card with talking points in the form of a checklist about the patient's story affects the patients care experience or not

During an office visit, the clinician and the patient engage in dialogue and begin a relationship. This traditionally starts with the patient telling their story, which conveys why they decided to seek care. This study will determine the influence of a checklist specifically about the patient's narrative. The checklist will be used during the interview portion of the visit, to remind the clinician to stay curious about the person before them, their experience of the illness, and their explanatory model, and to help ensure that empathic opportunities are not missed.

Eligibility Criteria:
Inclusion Criteria:

* New patients
* Orthopedic visit

Exclusion Criteria:

* Languages other than English or Spanish.
* Cognitive dysfunction precluding completion of questionnaires.
Gynecomastia Extension Study

The purpose of this study is to look at the effect of anastrozole (ZD1033, Arimidex™) in reducing gynecomastia in pubertal boys treated with placebo in Trial 1033US/0006 (another anastrozole study).


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have entered Trial 1033US/0006 and completed 6 months of treatment and one month of follow-up.
* Subjects must have gynecomastia, with one breast measuring at least 3 cm in diameter.

Exclusion Criteria:

* Subjects who have been given medications known to cause gynecomastia within the previous 3 months
The Natural History of Wounds in Patients With Dystrophic Epidermolysis Bullosa (DEB)

This study is a non-interventional, observational study that will evaluate the natural history of wounds in patients with Dystrophic Epidermolysis Bullosa (DEB) for inclusion into the Krystal Biotech Phase III protocol of B-VEC (previously KB103). Wound recurrence and wound size will be evaluated for up to four months.

The objective of this study is to analyze the selected wounds' natural history prior to including the selected wounds in the evaluation of safety and efficacy in Krystal Biotech's Phase III protocol of B-VEC.

Subjects will be enrolled upon obtaining consent and meeting eligibility criteria.

Patient Screening is done on-site, followed by the imaging of at least 1 wound, but up to 15 wounds. All remaining imaging will be performed remotely with a smartphone or tablet application.

Patients are on-trial for approximately four months.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent is provided. Patients 18 years of age and older, and parent(s)/legal guardian(s) of patients younger than 18 years of age, must provide written informed consent prior to participating in the study; additionally, informed assent will be obtained from patients younger than 18 years of age as specified by local requirements.
* Patient must have a documented diagnosis of DEB based on genetic analysis showing a mutation in COL7A1 or, in the opinion of the investigator, a confirmed diagnosis of DEB based on histologic criteria (antigen mapping or electron microscopy).
* Age: 6 months and older
* Patient must have at least 1 wound that is suitable for imaging, in the opinion of the investigator, at the time of enrollment.
* Patient is willing and able to undergo the protocol-specified procedures.

Exclusion Criteria:

* In the opinion of the investigator, inclusion poses an unacceptable risk to the patient or interpretation of these study data.
New Formula for Selection of Proper Size of Endotracheal Tube (ETT) in Children: Ultrasonographic Examination

Choosing the adequate size of endotracheal tube(ETT) in pediatric patients is important in all anesthesiologists, pediatricians, and critical care specialists. Inadequate ETT size will results in soft tissue injury to trachea by means of the pressure, insufficient ventilation, and aspiration, therefore choosing the adequate ETT size has very important clinical aspect.

Choosing the adequate size of endotracheal tube(ETT) in pediatric patients is important in all anesthesiologists, pediatricians, and critical care specialists. Inadequate ETT size will results in soft tissue injury to trachea by means of the pressure, insufficient ventilation, and aspiration, therefore choosing the adequate ETT size has very important clinical aspect.

Subglottis is the narrowest portion of upper airway. Thus, ETT size should be determined according to the subglottic diameter. Several conventional methods are available to determine ETT size. These methods are based on the demographic data of patient, such as age, weight, height, but could not be customized for each patient. Ultrasonography (US) is one of the most accurate method to measure the subglottic diameter. Also, US is quick, easy to perform, and non-invasive measure. The investigators tried to measure the exact subglottic diameter with US and analyze the correlation of the diameter and demographical data. Furthermore, the investigators will try to develop the equation that could determine the adequate ETT size based on demographical data, instead of actually measuring the subglottic diameter using US.

Eligibility Criteria:
Inclusion Criteria:

* children undergoing elective urological surgeries

Exclusion Criteria:

* children with anatomical airway problem or prematurely delivered children