cyrilzakka/clinical-trials huggingface dataset:
Promoting Behavioral Change for Oral Health in American Indian Mothers and Children

A program of motivational interviewing plus enhanced community services in prevention of early childhood caries vs. enhanced community services alone for American Indian mothers and their children will reduce the childrens' decayed, missing, and filled tooth surfaces measure over a 3-year period.

This is a randomized, controlled clinical trial. Six hundred mothers and their children will be randomized over a 2-year period to motivational interviewing (MI) plus enhanced community services vs. enhanced community services alone in equal numbers in the 2 groups. The MI sessions will involve home visits concentrating on the mitigation of behavioral risk factors for early childhood caries (ECC), shortly after childbirth and at 6, 12, and 18 months. The enhanced community services will involve development of culturally appropriate messages related to the mitigation of risk factors for ECC through public announcements and simple brochures. The primary outcome measure will be decayed, missing, and filled tooth surfaces (dmfs) of the children at ages 1, 2, and 3. Secondary outcomes will include children's ds, % with dmfs and ds \>0, mother's dental knowledge, attitudes, and behaviors, caries patterns, and costs.

Eligibility Criteria:
Inclusion Criteria:

* Be American Indian, as defined by the tribe
* Be mothers or caregivers of newborn children
* At least 15-44 years of age (Minors who are 15-17 years of age must get consent from a parent or legal guardian according to Tribal, State, and IHS rules and regulations)
* Able to read, understand, and sign a consent form/assent form,
* Be willing and able to follow study procedures and instructions.

Exclusion Criteria:

* No exclusion criteria. Although expected to be rare, if the father is a sole caregiver, he and his child will be eligible for the study.
Finistere Myeloma Observatory (OMYFIN)

Current molecular risk stratification of multiple myeloma (MM), based on the presence of t(4 ;14) and 17p deletion, cannot fully explain treatment outcome heterogeneity, as other features also predict prognosis. About 30% of genetic events map to chromosome 1 : most upregulated genes to 1q and most downregulated ones to 1p. CKS1B gains on 1q21 and CDKN2C loss on 1p32, both favoring cell cycle progression, portended impaired outcome in many but not all studies. Based on their recurrence and considering their functional convergence, we hypothesized CKS1B/CDKN2C copy number ratio to be a risk factor fitter than each aberration alone.

This single-center retrospective study, is designed to enroll all consecutive newly diagnosed adult patients aged ≥18 years, transplant-eligible and not. All patients are routinely tested for CKS1B and CDKN2C and treated according to consensus guidelines. Data are being collected from 2012. For each subject, we calculate a FISH-based ratio by CKS1B on CDKN2C copy number : it is equal to 1 with no change in copy number and \>1 in case of CKS1B gains, CDKN2C loss or both. In patients with CDKN2C biallelic loss, the ratio is not equal to 0, but to CKS1B copy number, as functional consequence should prevail over arithmetic result. We will, then, analyze separately the impact of CKS1B gains, CDKN2C loss and CKS1B/CDKN2C ratio on PFS and OS.

Eligibility Criteria:
Inclusion Criteria:

* Age at or over 18 years
* Symptomatic multiple myeloma
* Informed consent given
* FISH-based cytogenetic results obtained

Exclusion Criteria:

* Age under 18 years
* MGUS or SMM
* No informed consent
* No FISH-based cytogenetic results
Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia

The purpose of this study is to evaluate the safety, tolerability, efficacy, and pharmacokinetics of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.

* 8 weeks open-label treatment period with milnacipran.
* Followed by randomization to 8-weeks double blind treatment period for eligible patients

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary fibromyalgia
* 13-17 years of age
* To be eligible for screening, have average pain rating in the previous week of at least 3 but no more than 9 on an 11-point numeric rating scale
* To be eligible to enter into the open-label treatment period, have a 1-week mean of daily pain ratings of at least 3 but no more than 9 (11-point numeric rating scale) in the week before Baseline (Visit 2)
* To be eligible for randomization and entry into the double-blind treatment period, have a decrease of at least 50% in 1-week mean of daily pain ratings (11-point numeric rating scale) before Randomization (Visit 7) compared with the 1-week mean of daily pain ratings, in the week before Baseline (Visit 2)
* Unsatisfactory response to nonpharmacologic fibromyalgia treatment.

Exclusion Criteria:

* Severe psychiatric illness
* Severe renal impairment
* Evidence of active liver disease
* Pregnant or breastfeeding
* Significant risk of suicidality
* Unable, unwilling or inadvisable to discontinue prohibited medications
* History of alcohol abuse or drug abuse or dependence, within previous year
* Current systemic infection
* Autoimmune disease
* History of seizure disorder (other than febrile seizures)
Long- and Midterm Outcomes of Osteoarticular Infections in Paediatric Patients

Multi-centre clinical follow-up study on patients with a history of acute haematogenous osteomyelitis and/or septic arthritis. The aim is to describe the frequency of sequelae in these former patients with osteoarticular infections. Patients will be invited to participate in a single follow-up visit including a standardised interview and a clinical examination. The collected data will be analyzed together with data from the patient's hospital stay.

Clinical follow-up study on patients with a history of acute haematogenous osteomyelitis and/or septic arthritis and were admitted to one of the participating centres between 2005 and 2014.

Former patients will be invited to participate in a single-follow-up visit which comprises a standardised interview (pain, disabilities in daily life and regarding sports) and a standardized clinical examination of the previously affected body part. This includes assessment of range of motion in affected and adjacent joints and in case of previously affected lower extremity leg axis, gait and body height (percentile).

The data collected during the follow-up visit will be analyzed in a descriptive manner together with data of the patient's hospital stay including baseline data, laboratory works, microbiological results and both antibiotic and surgical treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were previously admitted to the participating centres between January 2005 and November 2014
* Patients with an International Classification of Disease code (ICD-10) discharge code of acute osteomyelitis (M86.00-M86.99) and/or septic arthritis (M00.00-M00.99)

Exclusion Criteria:

* onset of symptoms \> 2 weeks before admission
* history of penetrating wound or Prior surgery at affected limb
* incorrect ICD-10 coding
* chronic or severe underlying disease or Treatment at time of infection that possibly compromises the patient's immunologic Response (e.g. cancer, immunodeficiency, immunosuppressive therapy)
* insufficient command of German language to understand patient Information and informed consent
Building Resilient Families

Prior research suggests that it is possible to improve health outcomes in children with ACEs through multi-component interventions. The challenge for most communities is that health and education systems are fragmented and fail to accommodate families based upon different levels of need. This study utilizes cross-sectoral partnerships to mobilize three vectors (pediatricians, community health workers and parenting educators) to optimize the delivery of vital information and resources to a diverse population of families with ACEs. All vectors are trained in an evidence-informed curriculum to strengthen families and build youth resilience. The study design is a randomized controlled trial of 340 families of children between the ages of 3 to 11 who are generally healthy and have recently seen a pediatrician for a well-child visit.

To evaluate the efficacy of this intervention, pediatric patients are invited to participate in repeat evaluations within 2 weeks, 3 months, 6 months, and 12 months after their well-child visit. The study will evaluate the following: 1) the association between Child-ACE scores and biomarkers of toxic stress at baseline in children age 3-11 years old; 2) whether the intervention reduces toxic stress and child health and psychosocial problems at follow-up for children with ACEs compared to usual well-child care for children with ACEs; and 3) the impact of mediating and moderating variables. These results will demonstrate that for families with ACEs the intervention will decrease toxic stress associated with ACEs, improve health outcomes, and reduce health disparities.


Eligibility Criteria:
Inclusion Criteria:

* Ages 3-11
* Seen for a well-child visit at a participating pediatric clinic

Exclusion Criteria:

* \< 3 years or \>11 years of age
* Significant congenital medical problems
* Previous participation in parenting program (last 12 months)
* Sibling enrollment in current study
Ultrasonographic Airway Assessment in Predicting Difficult Laryngoscopy in Pediatric Patients Undergoing Elective Surgery

This study aims to evaluate the diagnostic accuracy of ultrasonographic airway examination in predicting difficult laryngoscopy in pediatric patients undergoing elective surgery.

A difficult airway in a paediatric patient can be a stressful situation for anaesthesiologists as the most common causes of anaesthesia-related deaths were the result of difficult intubation, which is a more common problem in children than in adults.

Ultrasonography is a valuable, promising tool for preoperative airway evaluation through identifying important son anatomy of the upper airway, such as epiglottis, thyroid cartilage, and vocal cords.

Many studies have shown that some ultrasonic parameters can predict difficult airways in adults, such as tongue thickness, hyomental distance in the extended position (HMDE), distance from skin to epiglottis (DSE), tongue volume, midsagittal tongue cross-sectional area (TCSA), and tongue width. However, whether these parameters can be used to predict difficult laryngoscopy in children is unclear and needs extensive studies

Eligibility Criteria:
Inclusion Criteria:

* Children aged (2-5) years old.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I or II.
* Undergoing elective surgery under general anaesthesia with endotracheal intubation.

Exclusion Criteria:

* Maxillofacial trauma
* Large mass.
* Scar under the chin.
* History of neck surgery or congenital anomalies of the head and neck as difficult intubation is expected in these cases.
Prophylactic Preoperative HIPEC in Advanced Gastric Cancer at High Risk of Peritoneal Recurrence

The study was designed to evaluate the efficacy of perioperative FLOT chemotherapy in combination with perioperative hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with advanced gastric cancer at high risk of peritoneal metastases. The impact of treatment on peritoneal recurrence and survival over 6 months, 1, 3 and 5 years will be assessed.

This is a randomized, multicenter, clinical trial in which 598 patients with advanced gastric cancer at high risk of peritoneal metastases are randomly allocated to receive either preoperative hyperthermic intraperitoneal chemotherapy (HIPEC) plus gastrectomy (experimental group) or gastrectomy alone (control group). All patients, regardless of allocation, will additionally receive 4 cycles of FLOT chemotherapy (docetaxel 50 mg/m2, oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 and 5-fluorouracil 2600 mg/m2) before surgery ± HIPEC and 4 cycles of FLOT chemotherapy after gastrectomy. The main outcome is frequency of peritoneal recurrence by 6-months post-operative. Patients will be followed for 5 years and undergo additional evaluations at 6 months, 1 year, 3 and 5 years.

The study will take place at 7 hospitals across Poland. All participating centers have the equipment and skills to perform all necessary procedures in this study. The below centers specialize in the treatment of stomach cancer with many documented years of experience. They are trained in the maintenance of a register, possess the skills to conduct appropriate research analyses and are equipped with a system for assessing the quality of both surgical and oncological treatment.

Eligibility Criteria:
Inclusion Criteria:

* Gastric cancer confirmed histopathologically in tumor specimens.
* Age 18-75 years.
* Advanced gastric cancer cT3 / cT4a / N0-3b.
* No distant metastases on computed tomography (CT) scan of the chest, abdomen and pelvis (cM0).
* Written consent to participate in the study.

Exclusion Criteria:

* No clear histopathological confirmation of gastric cancer.
* Age \> 75 years.
* Poor general condition (Performance Status 3 or more on the Eastern Cooperative Oncology Group (ECOG)/World Health Organization scale).
* Previous abdominal surgery (including oncological surgery), other than laparoscopic cholecystectomy or appendectomy (open or laparoscopic).
* Pregnancy and lactation.
* Refusal to participate or an inability to provide written consent.
* Coexisting cancer in another location.
* Systemic treatment or radiotherapy for another cancer.
* Dysphagia requiring surgical treatment (gastric resection or nutritional jejunostomy) before starting neoadjuvant treatment and indication for accelerated surgery for other reasons.
* Disqualification for perioperative FLOT4 chemotherapy as decided by a multi-specialist consultation.
Clinical Study Between Two Clindamycin 1%/Benzoyl Peroxide 5% Topical Gels

The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical Gel (Clindamycin- Benzoyl Peroxide Gel).


Eligibility Criteria:
Inclusion Criteria:

* Healthy men or women, 12 to 65 years of age
* Willing to participate and sign provide written consent
* Moderate to severe acne

Exclusion Criteria:

* Pregnant or lactating women
* History of unresponsiveness or hypersensitivity to clindamycin, benzoyl peroxide or lincomycin
* Use of systemic, topical or facial products which may interfere with the study
* Participation in any clinical study in the 30 days prior to study entry
* Prolonged exposure to sunlight or excessive exposure to UV lights
* Chronic use of NSAIDS
ConTTRibute: A Global Observational Study of Patients With Transthyretin (TTR)-Mediated Amyloidosis (ATTR Amyloidosis)

The purpose of this study is to:

* Describe epidemiological and clinical characteristics, natural history and real-world clinical management of ATTR amyloidosis patients
* Characterize the safety and effectiveness of patisiran and vutrisiran as part of routine clinical practice in the real-world clinical setting
* Describe disease emergence/progression in pre-symptomatic carriers of a known disease-causing transthyretin (TTR) variant


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ATTR amyloidosis or documented known disease-causing TTR variant for the cohort of pre-symptomatic carriers
* Germany Only: Patients must be treated per the summary of product characteristics (SmPC) for any approved treatment for ATTR amyloidosis

Exclusion Criteria:

* Current enrollment in a clinical trial for any investigational agent
The Effect of Periarticular Multi-Drug Regimen on Pain After Partial Hip Replacement

This prospective randomized study aims to evaluate the effectiveness of periarticular multi-drug regimen injection on the relief of pain in patients undergoing partial hip replacement.

Total 258 patients will be randomized into one of two groups (groupC or groupI) based on Excel number generation.

Patients in group C will receive no medication intraoperatively, and patients in group I will receive oral oxycodone and celecoxib preoperatively and a periarticular injection of multi-drug regimen during operation.

Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 1, 4, 7 postoperative day.

Patients in group I will receive oxycodone SR 10 mg, and celecoxib 200 mg with 10 ml of water 1 hour before surgery.

And patients in group I will receive periarticular injection of 50 ml solution which contains ropivacaine 15 mg, epinephrine 0.3 mg, cefmetazole 1000mg, ketorolac 30 mg and morphine HCL 10mg before closure of surgical wound.

Patients in group C will receive no medication.

Eligibility Criteria:
Inclusion Criteria:

* femoral neck fracture
* partial hip replacement

Exclusion Criteria:

* r/o infection
* reoperation
* mental change
Advanced Pelvic Surgical Oncology Database - Prospective Observational Study

Retrospective and prospective observational study of patients undergoing advanced pelvic oncological resection for maligancy including multi visceral resection, beyond TME resection and sacrectomy/flap reconstruction/urinary reconstruction at Glasgow Royal Infirmary.

Goal is to study and report outcomes for patients to characterise and understand major complications, natural history of resectional patients and identify areas for future interventional study.

Retrospective and prospective observational study of patients undergoing advanced pelvic oncological resection for maligancy including multi visceral resection, beyond TME resection and sacrectomy/flap reconstruction/urinary reconstruction at Glasgow Royal Infirmary.

Goal is to study and report outcomes for patients to characterise and understand major complications, natural history of resectional patients and identify areas for future interventional study..

Eligibility Criteria:
Inclusion Criteria:

* Advanced pelvic oncological resection defined as more than 1 pelvic organ resected

Exclusion Criteria:

-
Descriptive Analysis of Gut Microbiome Alterations in Hyperoxaluric Patients

To characterize the microbiome in 4 groups of subjects (primary hyperoxaluria type I (PH1), idiopathic CaOx stone, enteric hyperoxaluria (EH) and healthy participants) by comparing the number of species and diversity of the microbial populations and pathway for oxalate metabolism by paralleling the gene expression of enzymes involved in oxalate degradation by gut bacteria.

Kidney stones affect as much as 10% of the US population with the most common type of stones made of calcium oxalate. Calcium and oxalate are present in the urine and can bind to each other, and form calcium oxalate kidney stones. Oxalate is absorbed in the gut from the food that is eaten and is removed from the body through urination. Gut bacteria is thought to play a role in decreasing oxalate absorption in the gut and its levels in the urine. With this research we hope to learn about differences in the bacteria that live in the gut of different groups of participants who are likely to form kidney stones, as well as healthy individuals. We will study healthy people with no history of kidney stones, people with a history of calcium oxalate (CaOx) kidney stones, people with a genetic disease called primary hyperoxaluria type1 (PH1) that increases their chances to form calcium oxalate kidney stones and, people with enteric hyperoxaluria (EH) a disease in which individuals have short bowels due to surgery which lead them to get calcium oxalate kidney stones.

Our research questions are:

1. How different is the gut bacteria between participants with the conditions that make them more likely to form kidney stones and healthy participants with no history of kidney stones?
2. Is there any difference in the function of the individual bacteria, Oxalobacter formigenes known to reduce oxalate, between healthy participants with no history kidney stones and participants with PH1?

Eligibility Criteria:
Inclusion Criteria:

* Primary hyperoxaluria: Patients diagnosed with type I PH by genetic testing and part of the Rare Kidney Stone Consortium (RKSC) Primary hyperoxaluria registry
* Enteric hyperoxaluria: Patients with Roux-en-Y-gastric-bypass
* Idiopathic CaOx stone : History of passing or having surgically removed a calcium oxalate kidney stone within 5 years of recruitment
* Healthy participants with no history of kidney or bowel disease

Exclusion Criteria:

* History of kidney or liver transplant
* History of antibiotics use within 6 months of recruitment
Early Integrated Intervention in Severe Affective Disorders

The purpose of this study is to determine whether early integrated prophylactic combined medical and psychological outpatient treatment is associated with a better prognosis in patients with severe unipolar and bipolar affective disorders than standard treatment.

Patients who have been hospitalised for unipolar or bipolar disorder have a poor prognosis with highly increased risk of recurrence of episodes and increased risk of psychosocial dysfunction. It seems as integrated prophylactic combined medical and psychological out-patient treatment may lead to a better long-term prognosis in patients with affective disorders in general. It has not been specifically investigated whether such integrated treatment may improve long-term outcome if the intervention is offered early in the course of the affective illness.

Subjects: Patients currently discharged from first, second or third hospitalisation ever from psychiatric department with a diagnosis of severe single depressive episode/recurrent depression or with a diagnosis of manic/mixed episode or bipolar disorder.

Comparison: Early intervention with integrated prophylactic combined medical and psychological outpatient treatment as offered by a clinic for affective disorders compared with standard outpatient treatment as offered by community psychiatric centres, private specialists in psychiatry or general practitioners.

Eligibility Criteria:
Inclusion Criteria:

1. Discharge diagnosis of severe single depressive episode, recurrent depression, manic/mixed episode or bipolar disorder

Exclusion Criteria:

1. Moderate to severe dementia
2. Incapable in understanding or reading danish
3. Earlier randomised to the trial
Galectin-3 Level in Ankylosing Spondylitis Patients

Forty-five AS patients and 35 healthy controls were enrolled in this study. Patients diagnosed with AS according to Modified New York criteria were included in the study. Clinical and laboratory measurements, duration of symptoms, age and body mass index (BMI) of AS patients were performed and compared with age and BMI matched control group.

Detailed histories of all participants were obtained, and systemic and rheumatologic examinations were performed. We excluded all participants who had a history of hyperlipidemia, liver, renal, hematological, familial thyroid, neoplastic, autoimmune infectious diseases and receiving anti-inflammatory drugs.

We measured serum galectin-3 levels using a commercial chemiluminescent microparticle immunoassay. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was used to assess disease activity in AS patients.

Eligibility Criteria:
Inclusion Criteria:

* Ankylosing spondylitis patients
* Healthy controls

Exclusion Criteria:

* Hyperlipidemia
* Liver diseases
* Renal diseases
* Hematological diseases
* Familial thyroid diseases
* Neoplastic diseases
* Autoimmune infectious diseases
* Receiving anti-inflammatory drugs.