cyrilzakka/clinical-trials huggingface dataset:
The Efficacy and Safety Assessment of Huafu Shengji Ointment in Patients With Diabetic Foot of Qi Deficiency and Blood Stasis Syndrome

Diabetic foot ulcers, as a complication of diabetes with high disability and mortality rates, have become a significant global healthcare burden and medical challenge worldwide. The clinical situation of chronic non-healing ulcers leading to repeated amputations has not yet been resolved. In preliminary clinical practice, Huafu Shengji Ointment has been shown to significantly improve the complete healing rate of ulcer wounds. This study aims to further comprehensively evaluate the therapeutic effects of Huafu Shengji Ointment and provide high-quality evidence.


Eligibility Criteria:
Inclusion Criteria:

-

Patients who meet the following criteria will be included:

1. Patients who meet the diagnostic criteria for diabetic foot and have a Wagner grade of 1-5.
2. It is in line with the syndrome type of qi deficiency and blood stasis in traditional Chinese medicine.
3. Age between 35 and 80 years
4. The patient had no serious cardiac, liver, renal insufficiency or other systemic infections.
5. No hereditary or infectious diseases, no malignant tumors, and no severe malnutrition in patients.
6. Have understood the treatment modality and voluntarily signed the informed consent form.

Exclusion Criteria:

-

Patients who meet any of the following criteria will be excluded:

1. Patients who experience severe allergic reactions to the experimental medication and cannot undergo treatment.
2. Patients with poorly controlled serious conditions such as diabetic ketoacidosis, ketoacidosis, or diseases of the liver and kidneys.
3. Patients with psychiatric disorders or severe depression.
4. Women who are pregnant or breastfeeding.
5. Patients with severe organic tumors.
Amrubicin (AMR) Trial in Patients With Non-small Cell Lung Cancer

The study is to evaluate the effect of amrubicin (AMR) compared to docetaxel (DOC) in the treatment of non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of non-small cell lung cancer (NSCLC)
* 1 or 2 prior chemotherapy regimen including 1 platinum-based chemotherapy
* 20 or older but younger than 75 years of age

Exclusion Criteria:

* Symptomatic brain metastasis
* Interstitial pneumonia or pulmonary fibrosis
* Abnormal cardiac function or myocardial infraction within 6 months before study enrollment
* Active infection
VTE Prophylaxis Guidelines in Hospitalized Elders

Guideline directed use of pharmacologic Venous thromboembolism (VTE) prophylaxis emphasizes mobility evaluation. Mobility is a key component of risk stratification. Poor mobility evaluation by providers may be a significant barrier to appropriate use of VTE prophylaxis. The investigators aim is to propose to determine whether level of mobility during hospitalization is being used to influence use and duration of VTE prophylaxis among medically ill hospitalized elders. To achieve this aim, the investigator will collect prospective observational data to objectively measure inpatient mobility using patient mounted accelerometers during patient hospital stays.

The investigator's goal is to improve the appropriateness of use of VTE prophylaxis among those in which the risks of harm may outweigh the benefit. Results from this study will provide important insights about use of risk assessment, and the relationship between patient mobility and VTE prophylaxis. These results are critical to understanding how to take the next steps toward improving the appropriate use and safety of anticoagulants in hospitalized older adults. Information from this study could be used in future proposals to study interventions to ultimately improve hospital practice in the care of older adults.


Eligibility Criteria:
Inclusion Criteria:

1. Age of 60 or older
2. Admitted to General Medicine at Duke University

Exclusion Criteria:

1. Clear contraindications to pharmacologic VTE prophylaxis
2. Receiving surgery during their index hospital stay
3. On observation admission status
4. On negative pressure room respiratory isolation
5. Wrist site is not available, i.e. wearing bilateral wrist IVs, skin breakdown at the time of screening
6. Ankle site is not available, i.e. patients with leg ulcer at the time of screening
7. Lacking decision-making ability (such as from severe cognitive impairment) and no LAR available
8. Non-English speakers
Cardiac Arrhythmias in Dravet Syndrome

SUMMARY

Rationale:

People with Dravet Syndrome (DS), a rare epilepsy syndrome, have a high risk of Sudden Unexpected Death in Epilepsy (SUDEP). Mouse models indicated that the responsible sodium channel mutation (SCN1A) not only alters cortical excitability but also increases the propensity to arrhythmias. Little is known yet about the prevalence of seizure-induced arrhythmias in human DS subjects.

Objective:

To assess the prevalence of cardiac arrhythmias in DS and to compare the prevalence of cardiac arrhythmias between DS subjects and subjects with other types of epilepsy.

Study design:

Observational study.

Study population:

Subjects with Dravet syndrome and a known pathogenic SCN1A mutation, seizure frequency ≥ 1/week (all seizure types except for absences or myoclonias), age ≥ 6 years and no signs of self-harm. Each case will be matched to two historical controls (age +/- 5 years) from the EEG databases of the participating centres. Only those controls with two or more recorded seizures will be matched to the cases.

Intervention:

Not applicable

Main study parameters/endpoints:

Ictal asystole Ictal bradycardia Ictal QT-shortening/lengthening

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Participation does not carry risks. The sensor is wearable and miniaturised, thus minimising discomfort. If this nevertheless may occur, the study can be terminated. This study provides specific tools to investigate the seizure-related heart rate response. Subjects may thus benefit from participation by identification of otherwise unknown arrhythmias. The rationale of the study (the high SUDEP risk and the evidence in animal studies for arrhythmic cause of sudden death) specifically applies to DS, a rare epileptic syndrome including minors and incapacitated persons. The investigators believe that the lack of risks, the potential diagnostic benefit, the minimal intervention with novel and wearable sensors and the possibility to terminate the study in case of discomfort, justifies the study in this patient group.


Eligibility Criteria:
Criteria:

Cases must meet all of the following criteria:

1. DS with a known pathogenic SCN1A mutation
2. seizure frequency ≥ 1/week (all seizure types expect for absences or myoclonias)
3. no self-harm
4. age ≥ 6 years

Each case will be matched to two historical controls (age +/- 5 years). Controls will meet the following criteria:

1. definite diagnosis of epilepsy
2. no clinical suspicion of DS
3. at least two seizures recorded (all seizure types expect for absences or myoclonias) during video-EEG registration.
4. age ≥ 6 years
Measurement of Glycaemic Responses of Bakery and Confectionery Products

This study aims to determine the glycemic index, glycemic load and insulin index of eleven Fazer bakery and confectionary products.


Eligibility Criteria:
Inclusion Criteria:

* voluntarily given written consent for participation in research
* healthy man or women, age between 18 ang 65 years
* regular eating
* Body Mass Index 18,5 - 24,9 kg/m2

Exclusion Criteria:

* diabetes
* gastrointestinal diseases
* hepatic, kidney, pancreas or thyroid disease or disorder
* arthritis
* pregnancy or breast feeding
* smoking
* allergy
* severe diseases
* blood donation
A Phase I Bioavailability and Pharmacokinetic Study of [14C]-Ipatasertib Single Oral and Intravenous Doses in Healthy Male Subjects

This 2-period, open-label, nonrandomized study will be conducted to determine the absolute bioavailability as well as the absorption, metabolism, and excretion of ipatasertib and its metabolite(s). Healthy male participants will receive a single 200-mg oral dose of ipatasertib followed 1 hour later by an 80-mcg/800-nCi intravenous dose of \[14C\]-ipatasertib. After a 4-day observation period and 10-day washout, participants will receive a single 200-mg/100-mcCi oral dose of \[14C\]-ipatasertib with subsequent data collection for an additional 7 to 14 days until discharge criteria are met.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers 18 to 55 years of age, inclusive
* Body mass index (BMI) 18 to 32 kg/m2, inclusive

Exclusion Criteria:

* Females
* Clinically significant findings from medical history or screening evaluations
* Recent participation in any other investigational drug study or biologic agent study, or receipt of a previous radiolabeled investigational drug within 6 months prior to check-in
* Significant radiation exposure within 12 months prior to check-in
Gait, Stair Climbing and Postural Stability in Knee Osteoarthritis Patients After Hyaluronic Acid Injection

Treatment: five intro-articular Hyaluronic Acid injection

Assessment has two parts, that are as follow:

1. Postural stability and risk of fall assessment using Biodex stability index and "Timed up and Go" test
2. Gait and stair climbing assessment using Vicon motion capture system synchronized with four force plates.

For knee OA subjects, assessment was done in week one or before injection; and for healthy controls one assessment was performed.

This study aimed to assess the effect of hyaluronic acid injection on Postural stability, biomechanics of gait and stair climbing in individuals with bilateral knee osteoarthritis (OA).

Participants were individuals with knee OA (control and treatment) and healthy people.

Eligibility Criteria:
Inclusion Criteria:

* Mild and moderate bilateral knee osteoarthritis
* Age between 50 and 70 years

Exclusion Criteria:

* Recent Lower limb injury
* Diabetic
* Knee or hip replacement
* Knees HA injection in last 6 months
* Any neuromuscular disease such as stroke and Parkinson
The Potential Role of sRAGE, KL-6, and SP-D as Prognostic Factors in Children With COVID-19

COVID-19 causes a wide spectrum of clinical illness, from upper respiratory symptoms to severe respiratory failure and death. Several plasma biomarkers -such as IL-6, C-reactive protein (CRP), D-dimer, the neutrophil-to-lymphocyte ratio, and ferritin, among others- have been studied as markers of disease severity and prognosis. Besides, as alveolar damage biomarkers such as Surfactant protein D (SP-D), Krebs von den Lungen-6 (KL-6), and soluble Receptor for Advanced Glycation end products (sRAGE) can be used in lung diseases as well as COVID-19 pneumonia. The investigators hypothesized that serum SP-D, KL-6 and sRAGE levels increases in the setting of COVID-19 pneumonia. In this prospective study the investigators aimed to determine the clinical value of serum KL-6, SP-D and sRAGE levels as a prognostic marker in children with COVID-19 patients. In the literature review, it has been determined that there is no study conducted or published in pediatric patients for this purpose, and it is aimed that our study will be a pioneer study on this subject.

It aimed to determine the clinical value of serum KL-6, SP-D and sRAGE levels as a prognostic marker in children with COVID-19 patients.. This study was planned as a case-control study with patients hospitalized in the Haseki Training and Research Hospital Pediatric Infection Ward. A total of 150 children, including at least 30 patients in each group were included in the study. The study group was divided into three groups according to COVID-19 WHO clinical progression Scale: uninfected (Group 1), mild (Group 2) and moderate (group 3). In order to investigate the relationship between disease severity and alveolar damage, serum KL-6, SP-D and sRAGE levels and high sensitive C-reactive protein were measured. These biomarkers levels were compared between three groups.

Eligibility Criteria:
Inclusion Criteria:

1. Between 1 month-18 years old
2. SARS-CoV-2 PCR positive
3. Not having a chronic disease (cystic fibrosis, etc.)
4. Volunteering to participate in the study
5. Healty Control

Exclusion Criteria:

1. Having a chronic disease
2. Patients who could not be diagnosed with SARS-CoV-2 infection by laboratory and/or radiological examinations
3. Not volunteering to participate in the stud
Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)

This trial is conducted in Japan. This protocol describes an extension trial to supply hGH to subjects who wish continuous treatment after the long-term Phase 3 trial (GHLiquid-1519) until hGH products have been approved for GHDA in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who completed GHLiquid-1519.
* If the subject has a history of treatment for a tumor of pituitary or peripheral site, two years or more have to be passed since completion of surgery, radiotherapy or other treatment, and recurrence of the underlying disease to be excluded.
* Appropriate replacement therapy has been administered for more than 24 weeks for the treatment of other pituitary hormone deficiencies.

Exclusion Criteria:

* Subject with a history of acromegaly.
* Subject with diabetes mellitus.
* Subject suffering from malignancy.
* Several medical conditions
Early Childhood Obesity Prevention Program

This study is proposed on behalf of the Hartford Childhood Wellness Alliance, a 107 member, 35 group organization whose goal is to improve the health of children in Hartford, CT. In a randomized control trial, the primary aim of this study is to test the initial efficacy of a program of enhanced home visitation with neighborhood and community support to change maternal behaviors related to infant nutrition (sweetened beverage/juice consumption, breastfeeding and introduction of solids), parenting skills (establishing routines around sleep, reading cues for hunger, satiety, television time) and family wellness (improving the home food environment, enhancing physical activity). The investigators hypothesize that at 12 months of age, infants in the intervention arm will drink less sugar sweetened beverages/juices, will have ingested solids at an older age, will have been breastfed longer and more exclusively than infants in the control arm and will have less TV viewing, more established sleep routines and greater soothability (primary outcomes).

See Manuscript: 125. Cloutier MM, Wiley J, Wang Z, Grant A, Gorin AA. The Early Childhood Obesity Prevention Program (ECHO): An ecologically-based intervention delivered by home visitors for newborns and their mothers. BMC Public Health, 15:584 PMID 26073106, 2015.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the Nurturing Families Network Program
* Singleton birth \>34 weeks gestation
* Any race or ethnicity
* ECHO neighborhood
* Mothers and their newborns

Exclusion Criteria:

* Mothers or newborns with special health care needs
* Infant with major malformation
* Small for Gestational Age/low birth weight
Effectiveness of a Physical Activity Intervention on the Obesity of Schoolchildren

The purpose of this study is to evaluate the effectiveness of a recreational physical activity intervention (RPAI) for reducing the prevalence of overweight/obesity and other cardiovascular risk factors

The prevalence of overweight in Spanish children in the puberty age is among the highest in the world and increasing quickly. The investigators recently evaluated an after-school program of recreational physical activity to control obesity and other cardiovascular risk factors in primary school children in Cuenca. This program, known as the Movi program, reduced adiposity, increased serum apolipoprotein (apo) A-I concentration and reduced apo B concentration over one-year period.

Though the intervention MOVI had great acceptance between the children and his families, and it demonstrated to be effective opposite to the obesity, his results were relatively modest. For it, our hypothesis of work, which justifies this new project, is that a major intensity of the intervention, and a major weekly duration extending this one to the weekend, it might improve the efficiency on the obesity.

Eligibility Criteria:
The Boards of Governors (community participatory organ in each school) and the children's parents will inform of the study's aims and methods, and give their written consent to the children's participation. Similarly, the study will present classroom-by-classroom to the children, and their oral consent will obtain. Participant children will be free of serious learning difficulties, or physical or mental disorders, that could impede participation in the scheduled physical activities.
Medication Adherence in COPD--A Self-Regulation Study

To test the effectiveness of a self-management program for chronic obstructive disease (COPD) patients. The program to improve adherence could be conducted by nurses or other clinic staff in settings where comprehensive rehabilitation services were not available.

BACKGROUND:

In 1990, the available data on medication adherence among chronic obstructive pulmonary disease (COPD) patients consistently indicated that adherence was a significant problem. This was a particularly distressing finding, considering that pharmacological therapy was considered the backbone of COPD management in settings where comprehensive rehabilitation services were limited. Despite the importance of this issue and a large data base on how to enhance medication adherence among medical populations, there had been no empirical investigations evaluating the implementation of these strategies with COPD patients.

DESIGN NARRATIVE:

The prospective, controlled study randomized 230 emphysema and chronic bronchitis patients from an urban university medical center into either a "usual care", control group or into a self-management skills training program for improving adherence. The training program was based on self-management procedures for enhancing adherence which had proven efficacious with diverse populations.

Self-reported and objective measures of adherence were examined during the two month baseline period and the one year follow-up in the controlled study. A range of possible covariates including demographics, patient characteristics, treatment, and therapeutic outcome variables were also collected during the baseline phase and at the 6-month and 12-month follow-up visits in the controlled study to evaluate their relationship to the observed adherence levels.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Identification of Prostate Cancer Specific Markers in Patients Compared to Healthy Participants

This is an exploratory research study with the aim of identifying specific cancer biomarkers in various subtypes of prostate cancer. Blood samples will be collected from 60 participants divided into 40 patients and 20 healthy donors.

In this research study different commercial RUO (Research Use Only) antibodies will be purchased and then tested on blood samples obtained by patients affected by prostate cancer and by healthy participants as control. Sixty participants will be enrolled belonging to different risk categories:20 participants affected by prostate cancer at low risk, 20 participants affected by prostate cancer at high risk, and 20 participants without a cancer disease (healthy volunteers) as control.

Risk categorization is based on the definition of the European Association of Urology. After signing the informed consent form, participants will be screened to evaluate if they meet the eligibility criteria. If all the criteria are met, participants will be enrolled into the study and will be asked to provide some demographic and other data. A 13 ml blood sample will be collected by the participants and shipped to Sponsor's laboratories, in order to be processed and analysed.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give and sign a written informed consent for participation in the study
* Male, aged 18 years or above
* Diagnosed with prostate cancer at low or high risk
* Candidate to active surveillance (in case of low-risk disease) or treatment with curative intent such as radical prostatectomy or radiation therapy (in case of low risk patients not willing to undergo active surveillance or patients with high risk disease)
* Healthy participants undergoing a visit at the site for reason other than cancer diagnosis (including prostate cancer)

Exclusion Criteria:

* History of other malignancies other than prostate cancer (for healthy participants includes also prostate cancer)
* Undergone surgery or treatment for prostate cancer before enrolment
* Presence of known severe coagulation or haematological disorder
* Absence of written signed informed consent for participation in the study
CT Features of Interrupted Inferior Vena Cava With Azygous Continuation

Inferior vena cava (IVC) is the largest vein is the body, draining blood from the abdomen, pelvis and lower extremities. IVC anomalies can be congenital or acquired.

The origins of these anomalies are not entirely clear, and their incidence is uncertain.

Imaging plays a pivotal role in diagnosis to prevent misinterpretation. CT scan is a quick, available, and suitable imaging modality in emergency setting.

The aim of this retrospective monocentric study was of describe CT features of interrupted suprarenal inferior vena cava with azygous continuation.


Eligibility Criteria:
Inclusion Criteria:

* All patients with interrupted IVC with azygous continuation on CT scan were included in this study.

Exclusion Criteria:

* Patients under 18 years of age
* Patients no available CT scan.
Absorbable Suture Versus Nonabsorbable Suture Intradermal for the Skin Transverse Section in Cesarean

Context: Cesarean section is the most common surgery in women, both in developed and underdeveloped countries. However results are conflicting report in which material for intradermal suturing get better aesthetic result. Objective: To compare the aesthetic appearance of two suture materials, polyglecaprone 25 and polyamide (nylon) with intradermal sutures for skin closure in women undergoing cesarean section first. Methods: This is a clinical, prospective and randomized study which was conducted in the Department of Gynecology and Obstetrics of a tertiary Institute, Hospital das Clinicas Samuel Libânio, in PousoAlegre, Estate of Minas Gerais. Sixty women undergoing cesarean section were first included and randomized into two groups: group I (n = 30) polyamide and group II (n = 30) polyglecaprone 25. Hypertrophy, color and width of the wound were evaluated, receiving a score, according to Trimbos table, six months after surgery. Later the results were compared to non-parametric statistical tests


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent cesarean section
* No restriction of ethnicity, education or social class

Exclusion Criteria:

* Scarring Pfannenstiel prior
* Diabetic patients using drugs;
* Patients with collagen diseases
* Patients with pre operative tests to indicate any systemic sign of infection or site, not previously treated until the time of surgery.
* Patients who withdrew informed consent
* Patients who did not attend the pre scheduled dates for the controls after surgery .