cyrilzakka/clinical-trials huggingface dataset:
A Medical Home-Based Intervention to Prevent Child Neglect in High-Risk Families

Child maltreatment, particularly neglect, disproportionally affects low-income children with special health care needs (CSHCN) and has serious short and long-term consequences. Currently, few replicable, evidence-based preventive services exist for such families, particularly within the context of the patient-centered medical home. Child Abuse Prevention Problem Solving (CAPPS), a targeted problem solving intervention that addresses key risk and protective factors for child neglect, has the potential to improve key parenting skills and overall wellbeing, ultimately improving outcomes for high-risk children. This study is a multi-center randomized controlled efficacy trial of CAPPS to determine the impact on child neglect, adherence to recommended medical care, and family stressors and strengths.

Child maltreatment, particularly neglect, disproportionally affects low-income CSHCN and has serious short and long-term consequences. Currently, few replicable, evidence-based preventive services exist for such families, particularly within the context of the patient-centered medical home. CAPPS, a targeted problem solving intervention that addresses key risk and protective factors for child neglect, has the potential to improve key parenting skills and overall wellbeing, ultimately improving outcomes for high-risk children.

This is a multi-center randomized controlled efficacy trial of Child Abuse Prevention Problem Solving (CAPPS), a targeted intervention designed to address specific stressors faced by low-income parents of children with special health care needs (CSHCN) and to enhance family strengths previously been shown to reduce the risk of maltreatment. The study will enroll 250 parents of CSHCN who receive primary care in a network of urban patient-centered medical homes. The specific research aims are to 1: Decrease referrals to child protective services for neglect and increase adherence to recommended medical care; and 2: Decrease perceived social isolation, difficulty navigating complex services, and caregiver burden and enhance family strengths, including parental resilience, social connections, access to support in times of need, and knowledge of parenting and child development.

Eligibility Criteria:
Inclusion Criteria:

* Primary caregiver of a child under age 7 with a physical, emotional, or behavioral health condition
* Child on Medicaid
* Fluent in English or Spanish

Exclusion Criteria:

* Prior history of substantiated child maltreatment
* Prior history of report to child protective services for suspected child maltreatment
* Parent cognitively limited
Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation

In this study, investigators will examine the brain mechanism behind the synergistic effects of combining acupuncture and transcranial direct current stimulation (tDCS) treatments. Specifically, chronic low back pain (cLBP) patients will be recruited and randomized to one of four groups (30 per group, one month of treatment): 1) verum acupuncture + real tDCS, 2) sham acupuncture + real tDCS, 3) verum acupuncture + sham tDCS, and 4) sham acupuncture + sham tDCS. Investigators will study 1) the longitudinal (one-month) effects of different treatments as indicated by changes in resting state functional connectivity (rsFC), cerebral blood flow (CBF), clinical outcomes of low back pain, and quantitative sensory test (QST) and 2) the association between these changes.


Eligibility Criteria:
Inclusion Criteria:

* volunteers 18-60 years of age
* meet the classification criteria of chronic low back pain (having low back pain for more than 6 months), as determined by the referring physician
* at least 4/10 clinical pain on the 11-point Low Back Pain Numeric Rating Scale (LBP NRS)
* at least a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures

Exclusion Criteria:

* history of epilepsy or loss consciousness (LOC)
* specific causes of back pain (e.g. cancer, fractures, spinal stenosis, infections)
* complicated back problems (e.g. prior back surgery, medicolegal issues)
* the intent to undergo surgery during the time of involvement in the study
* history of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcomes. For example: asthma or claustrophobia
* presence of any contraindications to magnetic resonance imaging (MRI) scanning. For example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, inability to remain still in MRI scanner
* history of medical or psychiatric illness as determined by the investigator
* history of substance abuse or dependence
Evaluation of the Efficacy and Safety of Nise 100 mg in the Management of Osteoarthrosis (Gonarthrosis)

Study is conducted to evaluate safety and efficacy in patients with osteoarthritis

Osteoarthritis is the most common disorders of the joints, which gives a page more than 10% of the world population aged over 45 years (Woolf A. D., Pfleger B., Bergman S., 2009). The main clinical manifestations of the disease are pain in the joints and a violation of their functions. Therefore, one of the first tasks in the therapeutic program, these patients will decrease and possible pain relief. Nesteroi dnye anti-inflammatory drugs (NSAIDs) are the main group of medicines drugs used in medical practice in lech th Research Institute of pain in patients with lesions of the musculoskeletal system. The basis of the therapeutic effect of the second of these drugs is the suppression of the activity of Fe p IU NTA cyclooxygenase (COX). Prichё m, the suppression of the activity of COX-2 isoenzyme involved in the synthesis of prostaglandins, induce the development of pain and PLAYBACK tion and provides anti-inflammatory effects of NSAIDs. B Blocking out of the enzyme COX-1, which controls the synthesis of prostaglandins, have cited a protective properties, leading to side effects of NSAIDs These so called nye formed the basis for the creation of new NSAIDs that can selectively inhibit COX-2 and m and mally affect COX. - 1.

Nimesulide is a selective inhibitor of cyclooxygenase -2 vnym with Sat and anced analgesic and anti-inflammatory effect, but also has antibradikinin, antihistamine and antioxidant activity of Stu(Nasonov EL, 1999, 2001).

Eligibility Criteria:
Inclusion Criteria:

* patients 40 years old and older with verified diagnosis of OA of the knee joints according to the criteria of American College of Rheumatology (АСR);
* radiologic abnormalities complying with I-III grades of Kellgren;
* pain syndrome not less than 40 points according to 100-point visual analogue scale (VAS).

Exclusion Criteria:

* A history of the patient within the last 5 years malignancy of any organ or system regardless of whether the treatment and is carried on this occasion elk.
* The presence of acute ulcer disease of the gastrointestinal tract that is, over several recent years.
* Any data on the bleeding from the upper gastrointestinal tract.
* Severe disease: uncontrolled hypertension, expression n naya cardiovascular failure, a pathology of the hematopoietic system, and mellitus type I, and others.
* The presence of other rheumatic diseases with the exception of teoartroza.
* Liver disease (cirrhosis, chronic hepatitis).
* Abnormal liver function (ALT, AST, bilirubin more than 1.5 times the upper limit of normal).
* Impaired renal function (blood creatinine more than 1.5 times higher than it's ver limit of normal).
* Anemia (g emoglobin more than 10 g / l less than the lower limit of normal).
* Treatment with corticosteroids (systemic reception), warfarin and other coumarin governmental produ d.
* Hypersensitivity to the analgesic and antipyretic Wed d stvam, NSAIDs, sulfonamides.
* Pregnancy and lactation.
* Alcohol and drug abuse history.
Ondissolve in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting

The primary objective of the study is to examine the efficacy of Ondissolve for the prevention/rescue of Acute and Delayed Phase radiation induced nausea and vomiting (RINV) in patients undergoing single or multiple fraction, emetogenic palliative radiation therapy for painful bone metastases. The study population will be 30 patients seen in the RRRP at the Sunnybrook Odette Cancer Centre receiving palliative radiation therapy considered emetogenic for bone metastases. Patients will take the study medication (Ondissolve 8 mg) twice on each day of radiation therapy, at least one hour prior to treatment and repeat approximately 6-8 hours later the same day. Patients undergoing multiple fraction radiation therapy will take Ondissolve on weekends or holidays in between treatment. Secondary objectives include to evaluate key secondary endpoints related to RINV, and to investigate the ease and length of administration of protocol medicine. We hypothesize that Ondissolve will be effective in the prophylaxis of RINV, and the ease of use and administration will provide an appropriate delivery method for those unable to tolerate the oral form of ondansetron.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Patient will receive palliative radiation therapy considered emetogenic for bone metastases.
* Group 1: At least mild nausea and/or at least mild vomiting as recorded in the Baseline Nausea and Vomiting Data Collection Sheet
* Group 2: Nausea and vomiting recorded as 'none' in the Baseline Nausea and Vomiting Data Collection Sheet

Exclusion Criteria:

* Patient is scheduled to receive cranial radiation therapy during or within 10 days following completion of protocol RT.
* Patient received cranial RT within 7 days prior to commencement of protocol RT.
* Patient is scheduled to receive chemotherapy during or within 10 days following completion of protocol RT.
* Patient received moderately or highly emetogenic chemotherapy within 7 days prior to commencement of protocol RT.
* Patient is scheduled to change regimen/dose or start the use of corticosteroids (inhaled or topical permitted), or other medications considered to have antiemetic activity within 48 hours of protocol RT.
* Patient is scheduled to change regimen/dose or start the use of corticosteroids (inhaled or topical permitted), or other medications considered to have antiemetic activity during or within 10 days following completion of protocol RT.
* Patient is allergic to protocol medication.
* Patient has a Karnofsky Performance Status score \<40.
* Patient is a woman who is pregnant or of childbearing potential and is not using contraceptive measures.
Validation of BD Onclarity™ HPV Assay With PreservCyt® -ASCUS Samples

The purpose of the study is to compare the results of the Becton Dickinson (BD) Human Papilloma Virus (HPV) Assay on the Viper LT instrument from Liquid-based cytology media diluted in HPV diluent to adjudicated histology results from biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Females who are greater than or equal to 21 years of age,
* Subjects with a ASCUS (Atypical Squamous Cells - Undetermined Significance) cytology result,
* Females who provide informed consent

Exclusion Criteria:

* Known pregnant
* Prior complete or partial hysterectomy involving removal of cervix
* Conization, LEEP, cervical laser surgery or cryosurgery on the cervix has been performed in the last twelve months
* Colposcopy clinic referral patients
Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy

The purpose of this study is to determine the safety and efficacy of hand transplantation as a treatment for patients with loss of limb below the elbow, The study will focus on patients who have had loss of limb. The primary endpoint is the ability to use the tranplanted limb in activities of daily living at 18 months following transplantation measured by a quantitative functional test.

Study activities include several study visits over 18 months and include; demographics, medical history, vital signs, psychosocial evaluation, urine, blood test, chest x-ray, bone density scans, and biopsies. Subjects who are 18-65 and willing to travel to site and have loss of limb will be included in study evaluation.

Risks of the study include risk of rejection and infection after being transplanted. Additional risk are associated with procedures that include blood draws, biopsies, x-rays, and potential loss of confidentiality. All patient data will be kept electronically and in accordance with the requirements of Duke University. In addition to the experimental data, this database includes recipient and donor demographics and transplant relevant medical history, range of motion, sensation, and immunosuppressive medications. Data will be recorded and reported in accordance with the standards required by the United Network for Organ Sharing (UNOS).


Eligibility Criteria:
Inclusion Criteria:

1. Patients from 18-65 years old with loss of limb
2. Willingness and legal ability to give informed consent
3. Willingness to travel to study site for protocol specific samples to be taken, or in some cases, the ability to send samples via overnight mail

Exclusion Criteria:

* Any condition that precludes serial follow-up
* Any condition that would likely increase the risk of protocol participation or confound the interpretation of the data
* Any active malignancy or any history of a malignancy or lymphoma
* Inability or unwillingness to comply with protocol monitoring and therapy and immunodeficiency syndrome(s)
Study of PF-04523655 (REDD14NP) In Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (Wet AMD)

The aim of the study is to evaluate whether PF-04523655 is safe in the treatment of neovascular/wet AMD

Dose escalation safety study

Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 50 years old and in general good health. Patients with medically controlled chronic disease such as HTN, AODM, and hyperlipidemia may be included.
* Patient is capable of giving consent.
* Patient is willing and able to comply with the visit schedule and study procedures including follow-up visits.
* Patient has documented CNV secondary to AMD with evidence of active disease characterized by blood vessel leakage or evidence of hemorrhage.
* Patient has clear ocular media and adequate pupil dilation to allow good quality imaging by fundus photography.
* Patient's intraocular pressure is ≤ 25 mmHg

Exclusion Criteria:

* Patient is of childbearing potential. Every female patient is considered of child-bearing potential unless she has had sterilization surgery or is post-menopausal and has not had a menstrual period for at least 12 months.
* Patient has CNV due to causes other than AMD, including ocular or periocular infections.
* Patient has lesions not easily imaged and quantified.
* Patient has underlying systemic disease such as cardiac, neurological, infectious disease, uncontrolled diabetes mellitis, or disease of the eye other than AMD. Patient may have medically controlled glaucoma.
* Patient is participating in any concurrent interventional study.
Effect and Safety of Benaglutide or Metformin in Patients With Simple Obesity Who Have Inadequate Weight Control

This is a randomized, open, controlled and single-site clinical trail to investigate the effect and safety of Benaglutide or Metformin in patients with simple obesity who have inadequate weight control.

This is a randomized, open, controlled and single-site clinical trail to investigate the effect and safety of Benaglutide or Metformin in patients with simple obesity who have inadequate weight control.

Screening will be made to select eligible participants before intervention. Patients were randomly assigned to one of two groups(metformin or benaglutide) for therapies for 12 weeks including a two-week dose adjustment period and a 10-week dose stabilization period. Lifestyle interventions will be maintained during the treatment period. Subjects are followed up every 4 weeks for examinations.At the end of the study, data will be collected and analyzed.

Eligibility Criteria:
Inclusion Criteria:

(1)20 years old≤70 years old; (2) simple obesity, gender is not limited; (3) 28.0≤BMI≤37.5kg/m2; (4) Before the screening period, the body weight was controlled by lifestyle interventions (diet and exercise) for at least 3 months, and weight was decreased by \<5% from baseline; (5) Agree to sign the informed consent form;

Exclusion Criteria:

1. Accurately diagnosed as having type 1 or type 2 diabetes according to the WHO 1999 diagnostic criteria;
2. Use weight loss drugs within 3 months before screening;
3. Metformin was used within the first 3 months of screening;
4. Malignant tumors (excluding basal cell or squamous cell carcinoma treated) within 5 years before enrollment
5. Alanine aminotransferase or aspartate aminotransferase \> 3 times the upper limit of normal or total serum bilirubin (TB) \>34.2 μmol/L (\>2 mg/dL)
6. Patients with moderate/severe renal impairment or end-stage renal disease (eGFR \< 60 mL/min/1.73 m2); male subjects with serum creatinine (Cr) ≥133 μmol/L (≥1.50 mg/dL Serum Cr in female subjects was ≥124 μmol/L (\>1.40 mg/dL);
7. Severe heart, lung, nervous, mental and infectious diseases;
8. Pregnancy, lactation and recent pregnancy plans;
9. Alternate or chronic systemic corticosteroid therapy, defined as treatment with any dose of systemic corticosteroids within 3 months of enrollment visit V1 \> 4 weeks
10. History of alcohol abuse, history of abuse of active drugs (opioids, analgesics, etc.) within 6 months before enrollment;
11. Give any other test drug within 30 days before enrollment or within 5 half-lives of other test drugs;
12. Patients with past history or family history of medullitary thyroid cancer (MTC) and patients with type 2 multiple endocrine tumor syndrome (MEN2);
13. Inability to tolerate benalutide, metformin;
14. Any influence of the investigator's judgment on enrollment.
The Role of 68Ga-FAPI-04 PET/CT as a Problem Solving Imaging Modality in Various Malignancies

The aim of the suggested study is to assess the added value of 68Ga-FAPI-04 PET/CT over 18F-FDG PET/CT in evaluating the extent of disease in patients with various malignancies, in whom a diagnostic challenge is met, such as inconclusive findings on 18F-FDG PET/CT or other imaging studies, better delineation of tumor extent prior to therapy, and with emphasis on malignancies known to show variable avidity to FDG and at times, no uptake at all. Also patients unable to optimally comply with the required preparation for FDG imaging, such as diabetic patients who struggle in achieving glycemic control.


Eligibility Criteria:
Inclusion Criteria:

The study population will include up to 50 patients with disease in whom a diagnostic challenge is met, including but not limited to:

1. Inconclusive findings on 18F-FDG PET/CT or other imaging modalities.
2. Better delineation of tumor extent prior to therapy
3. Malignancies known to show variable avidity to FDG and at times, no uptake at all (e.g. Exocrine Pancreatic cancer, Gastric carcinoma, Mucin-producing or Signet-ring carcinoma).
4. Patients unable to optimally comply with the required preparation for FDG imaging.

   * The study population will include only patients treated in Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel, and referred by their attending physicians, of whom are part of the hospital staff.

Exclusion Criteria:

* Age \< 18 years.
* Pregnant females.
* Patients who are reluctant to undergo both FDG and FAPI PET scans.
Association of Bone Quality and Quantity With Vascular Calcification

The purpose of this study is to determine if there is a link between calcium build up in the veins or arteries (including the veins/arteries of the heart) and deterioration of the bone. This will help understand if there is a connection between heart disease and bone disease.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* 30 years of age or older
* Must already be scheduled to have a CT examination of the arteries of the heart

Exclusion Criteria:

* Diagnosed with bone cancer
* Previous diagnosis of cancer that's spread to the bone
* History of cancer that involves bone marrow
* Any bone disease other than osteoporosis
* Any disease which leads to serious osteoporosis or vascular calcification such as:

  * kidney disease
  * thyroid and adrenal disease
  * anorexia nervosa
  * secondary osteoporosis
Maternal Treatment With ACE-inhibitors and Breastfeeding: a Mono-centric Study on the Exposure Through Breast Milk

The ACE-inhibitors is one group of essential medication for which reliable data on the safety during breastfeeding is lacking. ACE inhibitors are indicated for several severe or life-threatening disorders like hypertension, heart failure or nephrotic range proteinuria and diabetic nephropathy. However, data on the transfer of ACE inhibitors into the human breast milk remains very limited. After delivery, ACE inhibitor therapy is often postponed if the mother is breastfeeding, requiring multiple other medications to control the disease, or switched from long to short acting forms, decreasing therapeutic adherence. Limited available data shows that the transfer of ACE-inhibitors into the milk is probably low, and thus that ACE-inhibitor are likely to be safe during breastfeeding.

The objective of this trial is to collect information about the breast milk transfer, and subsequent infant exposure and general health outcome to selected maternal medication (ACE inhibitors) in patients from UZ Leuven. Furthermore, we will also use these data to verify the predictive performance of physiologically-based pharmacokinetic models to predict breast milk and subsequent neonatal exposure to maternal medication during lactation. The medicines that will be investigated are perindopril, captopril, cilazapril, enalapril, fosinopril, lisinopril, quinapril, ramipril and zofenopril.

The investigators will enroll +/-10 mothers, who have been prescribed ACE inhibitors for medical reasons and are breastfeeding their infant while taking this medication.The mother will be asked to collect milk samples during 24 h and 2 blood samples: one at the time of milk pumping the first time after medication intake, and one at the last pumping session of the 24 h. Furthermore, we will ask the parents if we can collect a blood sample of the child (1mL/kg, and max 2,5mL). In addition, clinical maternal and infant variables will be collected, as well as medication intake, sampling information and general infant health.

To conclude, with this study we hope to generate human data about the use of ACE inhibitors during breastfeeding. This information is an essential first step towards evidence-based risk assessment on the use of these drugs during lactation.


Eligibility Criteria:
Inclusion Criteria:

For lactating mothers

* Lactating
* 0-6 months postpartum
* Age: ≥18 year
* On steady state ACE-inhibitor therapy, for any indication (e.g. perindopril, captopril, cilazapril, enalapril, fosinopril, lisinopril, quinapril, ramipril \& zofenopril)
* Willing to express breast milk
* Informed consent to participate and for processing their personal data

For neonates/infants

* 0-6 months of age at inclusion of the mother
* Postmenstrual age: ≥ 37 weeks
* In case of blood sampling: exclusively breastfed at the time of sampling
* Parental informed consent to participate and for processing their personal data

Exclusion Criteria:

* Participation in a trial with an investigational product within the previous three months
* Not meeting the inclusion criteria