cyrilzakka/clinical-trials huggingface dataset:
Safety of Autologous Cord Blood Cells in HLHS Patients During Norwood Heart Surgery

This study aims to evaluate the safety and feasibility of coronary infusion of autologous placental cord blood mononuclear cells during the Norwood heart operation in newborn hypoplastic left heart syndrome (HLHS) patients.

This is a Phase I, open label safety study. Autologous cord blood mononuclear cells (stem cell containing, cord blood buffy coat fraction) was delivered by coronary infusion during the Norwood cardiopulmonary bypass operation in 10 antenatally diagnosed HLHS patients within 2-3 days of birth. Safety and clinical status monitoring was performed to Stage II surgical intervention for HLHS (at approximately 3 months of age). Treated patients will continue to be assessed beyond the trial during follow up between Stage II and III (Fontan) surgical interventions.

Eligibility Criteria:
Inclusion Criteria:

* Male and females with antenatally diagnosed Hypoplastic Left Heart Syndrome (all types requiring Norwood operation)
* Written informed consent by parents/legal guardian
* Successful aseptic collection of autologous cord blood unit and transfer of buffy coat mononucleocyte fraction to cold storage pending cardiac surgery within 2-4 days

Exclusion Criteria:

Patient:

* does not have autologous cord blood cells available at the time of cardiopulmonary bypass surgery
* has evidence of arrhythmia requiring anti-arrhythmia therapy
* has an additional congenital diagnosis that contributes to conditions such as an immune system disorder, immune deficiency, complex metabolic disorder, brain dysplasia or progressive neurological degenerative disorder
* has other clinical complexity deemed by the cardiac surgeon to make the patient unsuitable for inclusion in the trial

Mother:

• is serum positive for HIV, hepatitis or other significant pathogen and has known allergies to penicillin, streptomycin or other antibiotic
Regional Fatty Acid Metabolism in Humans

There are several studies looking at how dietary fat is metabolized by humans. We give special meals and collect blood, breath, urine and fat samples to study how people burn and store dietary fat.


Eligibility Criteria:
Inclusion Criteria: BMI\<25 Lean, sedentary with family history of DM2 and Lean, sedentary without family history of DM2 and Lean, active without family history of DM2. Non-smokers.

Exclusion Criteria: Known systemic illness, cardiac and vascular disease and BP\> 160/95 on HTN meds. Medications that affect fat metabolism.

We do not pay for travel expenses.
Effect of Routine Deworming on Weight of Children

Soil Transmitted Helminths (STH) are among the most common infections in the world today. The World Health Organization (WHO) recommends mass administration of deworming medicine as a single routine annual dose to all school age children (SAC)(age 5-16 years) in countries where prevalence of Soil Transmitted Helminthic Infections (STHI) is \> 20% as a safe public health intervention that promotes healthy growth (Category 2 Recommendation). Pakistan is classified as a low burden community with a reported prevalence of STHI \<50%, however,routine deworming is not a policy in Pakistan. Currently, Pakistan is also facing a huge burden of malnutrition in all age groups especially in population belonging to low socioeconomic group. Incidentally, worm infestation by STH also occurs in this group due to associated lack of hygiene and poor living conditions. The coexistence of even moderate STH infections can cause or aggravate malnutrition. The urban slums of Karachi provide environmental, social and behavioral conditions that favor both STH infections and a risk of under nutrition. It is unknown if administering routine dose of deworming medicine to SAC as per WHO recommendation will contribute to improvement in indicators of nutrition status in Pakistani children living in urban slum conditions by eliminating worm infection.Therefore, this study is being conducted to determine the effect of deworming on weight of School Age Children aged between 5 to 16 years.

A randomized control trial will be conducted in an urban slum of Karachi. Eligible 5 to 16 year old school age children will be enrolled after parental consent. The calculated total sample size is n= 258. Subjects will be visited at home by researcher and background information, risk factor presence and baseline measurements of weight, Mid Upper Arm Circumference (MUAC) and tricep skinfold thickness (TSF) will be measured. The intervention arm will be administered a single dose of chewable Albendazole 400 mg and the placebo arm will receive 400 mg chewable calcium tablets. The weight, MUAC and TSF will be measured again after 8 weeks to determine the change if any. The selection of locality and allocation of intervention will be done using simple random sampling and computer generated random numbers.

Eligibility Criteria:
Inclusion Criteria:

* Aged 5 - 16 years, Healthy, Able to chew/swallow tablets

Exclusion Criteria:

* Acutely ill
* Previous deworming dose \< 6 months ago
* Intellectually challenged or physical condition interfering with measurement of primary outcome variables
A Multi-Center Randomised Controlled Study to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer

Laparoscopic surgery has been widely accepted for its minimal invasion and safety. However, whether it has the same survival benefit as the traditional open surgery in Chinese population is still unknown. So we designed this study to evaluate the 3 year disease free survival rate in the laparoscopic group versus the open surgery group.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Pathologically confirmed adenocarcinoma
* Pre-surgery image staging as (CT/MRI):T2-3,N0-2,M0,(TNM stage，AJCC，version of 2003)
* Single tumor locating at cecum, ascending colon, descending colon, sigmoid colon, rectosigmoid junction, rectum(distance from anal verge more than 7cm)
* Tumor diameter less than 6cm
* Age 18-75 year
* ECOG 0-2
* Predicted survival longer than 6 months
* Normal liver, renal, bone marrow function: (GPT less than 2 ULN，total bilirubin less than 1.5mg/dl，Cr less than 1.5 ULN，WBC more than 4×109/L，PLT more than 100×109/L)
* No previous history of gastrointestinal surgery
* No previous history of chemotherapy or radiotherapy

Exclusion criteria

* Severe and uncontrolled medical disease including unstable angina pectoris, cardiac infarction and cerebral attack in 6 months
* Could not tolerant general anesthesia or surgery for other organ dis-function
* Allergy to chemotherapeutical agents in the protocol
* History of other malignant tumor within 5 years
* Severe mental disorder
* Continued systematic steroid therapy
* Woman during pregnancy or lactation
* Under study of other clinical trial
* No compliance of the protocol
* Discovery of distant metastasis during surgery
* Postsurgery stage of I or IV tumors
Standard Infusion Carboplatin Versus Prophylactic Extended Infusion Carboplatin in Patients With Patients With Recurrent, Ovary, Fallopian Tube, and Primary Peritoneal Cancer

Patients who have this kind of cancer are often treated with several drugs. Carboplatin is one that seems to work for many treatment cycles. Even though it may work against the cancer, the patient can become allergic to it. If that happens, they would have to stop taking the drug. The standard way to give carboplatin is by vein over 30 minutes. Some people have been given carboplatin over 3 hours rather than 30 minutes and had fewer allergies than expected.

The purpose of this study is to:

Find out if giving carboplatin over three hours can prevent the allergy.

See if medicine given before the carboplatin can help reduce the risk of allergic reactions.


Eligibility Criteria:
Inclusion Criteria:

* MSKCC Histologically confirmed ovarian, fallopian tube or primary peritoneal carcinoma.
* Patient has received at least one prior platinum-containing (cisplatin or carboplatin) regimen
* Age ≥ 21 years old
* Karnofsky Performance Status (KPS) \> or = to 70%
* Adequate hematologic, hepatic and renal function as defined below:
* Hemoglobin ≥ 7.0 g/dl
* Absolute neutrophil count ≥ 1,000/mm3
* Platelet count ≥ 100,000/mm3
* Serum creatinine ≤ 1.5 x the upper limit of normal or calculated creatinine clearance ≥ 60 mL/min

Exclusion Criteria:

* Prior carboplatin or cisplatin hypersensitivity reaction
* Uncontrolled intercurrent illness including infection, congestive heart failure, myocardial infarction, transient ischemic attack or stroke within 6 months. Any such conditions that have occurred in the last 6 months but are no longer active at the time of registration are not considered exclusionary.
* Patients receiving other investigational agents
* Patients with HIV disease will be permitted, only if they are on effective antiretroviral therapy, have a CD4 count greater than 400, and have had no opportunistic infections within the past 6 months
* Pregnant or lactating women
* Life expectancy of less than 12 weeks
Mindfulness-based Mobile Applications Program

The goal of this type of study: quasi-experimental clinical trial . The purpose of this study is to explore the effects of applying mindfulness-based mobile applications program to maintaining mental health of emergency nurses during providing care to COVID-19 patients. The main question\[s\] it aims to answer are:

1. To explore the effect of mindfulness-based mobile device-assisted program on care stress of emergency nurses caring for COVID-19 patients.
2. To explore the impact of mindfulness-based mobile device-assisted programs on the psychological distress of emergency nurses caring for COVID-19 patients.
3. To explore the impact of a mindfulness-based mobile device-assisted program on compassion fatigue in emergency nurses caring for COVID-19 patients.

Participants will Mindfulness-based mobile device is provided to experimental group as assistance for 2 weeks. In the contrary, no intervention measure was assigned in the control group. Scale exam was performed before and after the program in both groups at the same time.

This study was a quasi-experimental study with two groups of pretest and posttest to facilitate sampling from the emergency room of Mackay Memorial Hospital. Emergency nurses at Taipei Mackay Memorial Hospital were in the experimental group, and emergency nurses at Tamsui Mackay Memorial Hospital were in the control group. These cases are expected to be accepted. There were 54 people in the experimental group and 54 people in the control group. The experimental group received a two-week mindfulness-based mobility device-assisted program. The program is a mobile application developed by researchers and designed for use on smartphones, tablets, and other mobile devices. The program content is facilitated and guided by certified instructors from the Center for Mindfulness (CFM) at the University of Massachusetts Medical School. Five suitable sound files were provided to guide subjects in practicing mindfulness. Each audio file is approximately 10 to 15 minutes in length. The control group did not take any intervention measures. The experimental group was tested on the scale before and after the program, and the control group was also measured at the same time. Research tools include the Nursing Stress Scale, Psychological Distress Scale, and Compassion Exhaustion Scale. The SPSS 20.0 software package was used for statistical analysis and processing of the data, and covariates were used to analyze the results. The findings will help improve mental health by reducing stress, psychological distress and compassion fatigue among emergency nurse practitioners caring for COVID-19 patients.

Eligibility Criteria:
Inclusion Criteria:

Have a license to practice nurses; have worked in the medical center for more than three months; and are emergency clinical nurses who have experience in caring for COVID-19 nucleic acid test patients.

Exclusion Criteria:

The exclusion criteria were emergency clinical nurses who had received courses related to mindfulness training.
Schizophrenia and Genetic Counseling

This research is designed to investigate the perceptions and opinions of individuals who either have schizophrenia or who have a family member with schizophrenia, in relation to genetic counseling. Data will be collected via a 15 minute online questionnaire. There is also an option for respondents to participate in a 45 minute interview if they wish.

It is expected that the study will show that adequate information about genetic counseling is not provided to these individuals. It is also hoped that this research will help to make genetic counseling sessions more specific to people with schizophrenia in their family.

For more information please go to the following website:

http://schizophreniageneticcounseling.blogspot.com

Eligibility Criteria:
Inclusion Criteria:

* anyone diagnosed with schizophrenia OR who has family member diagnosed with schizophrenia
* Over 18 years old
Effects of Tibilone on Bone Density, Menopause Symptoms and Breast Density in Women After Prophylactic Oophorectomy

Women undergoing surgical menopause often experience marked menopausal side effects but are reluctant to use estrogen or other female hormones to ease the transition to menopause because of worries that the hormones may increase breast cancer risks. This study will evaluate tibolone in women experiencing surgical menopause to assess its effects on bone health, menopause symptoms and breast density.

Women interested in participating in this study will be allowed to use hormones to manage symptoms for up to 3 months before beginning the study. Those choosing not to take hormones may enroll in the study immediately.

All women will have a baseline mammogram, breast examination, and bone study density performed, along with blood and urine analysis for measurement of bone markers. They will also be asked to take a questionnaire.

Patients will take either tibolone or placebo once daily for 1 year. Neither the patient or the physician will be aware of which treatment a woman is taking during the study.

Patients will return at 6 and 12 months to have a physical examination, blood work, urine collection and bone studies. At one year, a repeat mammogram will be performed. There are also some questionnaires asking about menopause symptoms that will be performed at intervals during the study.

It is also recommended that patients take calcium and vitamin D throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Good overall health
* Premenopausal at the time of enrollment if before their oophorectomy
* Will undergo or have undergone an oophorectomy
* Negative breast examination and negative breast imaging studies

Exclusion Criteria:

* History of breast cancer, ductal carcinoma in situ (DCIS) or other cancer except for carcinoma in situ of the cervix or basal cell carcinoma of the skin
* History of ovarian cancer, breast cancer (or DCIS) or other malignancy
* Low bone mass compared with age-adjusted controls
* Current or recent exposure (within 3 months) to medications that alter bone metabolism
* Estrogens, progesterones, androgens, tamoxifen or raloxifene within 3 months of randomization
* History of significant medical problems potentially related to estrogens
* History of Paget's disease of bone, ankylosing spondylitis, rheumatoid arthritis or other metabolic bone disease, vitamin D deficiency, hyperparathyroidism, or newly diagnosed hyperthyroidism
* Body mass index (BMI) \> 32
* High-density lipoprotein (HDL) cholesterol \< 40 mg/dl
* Women whose uterus was retained and who have a history of uterine abnormalities
Askina Calgitrol Paste Diabetic Foot Ulcers

The purpose of this study is to assess the efficacy of Askina® Calgitrol® Paste in reducing local infection in subjects treated for mildly infected Diabetic Foot Ulcers (DFU) with Askina® Calgitrol® Paste.


Eligibility Criteria:
Inclusion Criteria:

* Subject older than 18 years old
* Provision of written consent by the subject themselves
* Subjects with a Texas stage I-B wound below the malleolus: superficial and infected (Wagner-Armstrong classification system).
* Subjects with a mildly infected wound according to the Infectious Diseases Society of America (IDSA).
* Size of wound \>2 cm2.
* Absence of ischaemia of the lower limb as assessed by :

  1. Transcutaneous oxygen pressure (TcPO2) \> 30 mmHg.
  2. Toe pressure \> 50 mmHg.
  3. Ankle pressure \> 70 mmHg.
* Capable of following Study instructions.
* Compliant with treatment and in particular with off-loading regime.
* Stable management of their diabetes as defined by an HbA1C (%) of 12%

Exclusion Criteria:

* Subjects who are \<18 years old.
* Subjects with a documented sensitivity to alginates or silver.
* Subjects taking a medication or using a device comprising silver.
* Subjects already taking antibiotics before enrolment
* Subjects undergoing dialysis.
* Subjects using therapy known to be immune-compromising such as systemic anti-neoplastic drugs and/or systemic cortico-steriods.
* Pregnancy
* Breast-feeding
* Currently participating in another clinical trial, or who have participated in another clinical trial in the last 6 weeks or who have previously taken part in this study
Precision Vaccine Promotion in Underserved Populations

Previous studies have shown that low-cost, behavioral nudges through texting can increase influenza vaccination uptake compared to usual care. However, there are limited studies that evaluate the effect of decreasing barriers to scheduling, especially within safety net populations. The setting for this study, DHS, is the second largest public delivery system in the country and serves approximately half a million diverse patients that are eligible for vaccinations annually. This pilot study (one arm in a larger randomized controlled trial) will examine the effect of text messages highlighting MediCal health plan transportation resources (vs standard text messaging) on influenza vaccination rates in adults during the 2022-2023 flu season.


Eligibility Criteria:
Inclusion Criteria:

* Los Angeles County Department of Health Services (LACDHS) primary care patients over 6 months of age

Exclusion Criteria:

* LACDHS patients less than 6 months of age
Concurrent Xeloda and Radiotherapy for Bone Metastases

Hypothesis: Radiosensitization using Xeloda should improve the rate of complete pain relief.

Primary Objective:

* To determine the frequency of pain relief for the proposed regimen.

Secondary Objective(s):

* To determine the duration of pain relief and narcotic relief for the proposed regimen.
* To determine the frequency of narcotic relief for the proposed regimen.
* To determine the toxicity of concurrent UFT and radiotherapy in patients with bone metastases.


Eligibility Criteria:
Inclusion Criteria:

1. The patient must be 18 years of age or older.
2. The patient must have epithelial malignancy.
3. Radiographic evidence of bone metastasis is required. Acceptable studies include plain radiographs, radionuclide bone scans, computed tomography scans and magnetic resonance imaging.
4. The patient must have pain that appears to be related to the radiographically documented metastasis.
5. Patients must have an estimated life expectancy of 3 months or greater.
6. Signed study-specific informed consent.
7. Karnofsky performance status  40.
8. Calculated creatinine clearance \> 50 ml/min
A Safety Study to Investigate the Skin Irritancy Potential of Diclofenac-Menthol Gel

This research study is being conducted to investigate the skin irritancy potential of a new medication which contains two active ingredients (diclofenac and menthol) together in a gel formulation and is being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, sprains and strains.

Approximately 36 healthy subject volunteers will be exposed to seven test products (study treatment gel and six control products) simultaneously for 21 consecutive days. The seven test products will be applied using a 7-channel patch assembly that will be affixed to the infrascapular areas of the back of each subject for approximately 24 hours daily.

The subject will return to the clinic to undergo a skin irritation assessment at approximately 24 hours after the time the patch assembly was initially affixed.

During the visits, doctors or trained staff members will examine the signs of irritation (if any) of the skin where the test products are applied. The skin irritation assessment will primarily characterize the test products individually in terms of symptomatology using a 7-point categorical scale ranging from 1 (glazing and/or wrinkling) to 7 (erosion and/or vesiculation).

Eligibility Criteria:
Inclusion Criteria:

* Male/female volunteer ≥18 years
* No systemic/dermatologic disorder

Exclusion Criteria:

* Visible skin disease at the site of application that might interfere with skin assessments
* Allergy or hypersensitivity to NSAIDs or menthol or any of the excipients in the test product
* History of physical or psychiatric illness, or medical disorder
* Recent history of alcohol or drug abuse
* Pregnant or lactating females
Adherence in the Childhood Asthma Management Program

To evaluate three adherence promoting interventions within the Childhood Asthma Management Program (CAMP), an eight center clinical trial that compared pediatric asthma therapies in children five to twelve years old.

BACKGROUND:

The success of any therapeutic intervention, whether preventive or curative, is ultimately dependent on the individual's adherence to treatment. Unfortunately, the failure of a large percentage of patients to adhere to prescribed medical regimens is a widely recognized and well documented phenomenon. It has been estimated that as many as 50 percent of patients do not take their prescribed medications, and of those remaining, less than two-thirds take their medication as prescribed.

The study was part of a two grant initiative, "Evaluation of Adherence Interventions in Clinical Trials", developed by the Behavioral Medicine Branch staff and the Clinical Trials Branch staff and by members of the Clinical Applications and Prevention Advisory Committee Behavioral Medicine and Prevention Working Groups. The initiative, jointly sponsored by the NHLBI and the National Center for Nursing Research (NCNR), was released in September 1991 and awarded in September 1992.

DESIGN NARRATIVE:

All participants medication adherence was measured by self-report, canister weighing, and with the Nebulizer Chronolog, a microprocessor-based monitor of inhaler adherence that recorded the date and time of each inhaler use. The subjects were assigned to one of three adherence treatment groups; a control condition, an informed condition, and a feedback condition. Adherence outcomes were analyzed with respect to treatment assignment, as well as CAMP measures of asthma morbidity, pulmonary function, medication side effects, psychosocial development, and quality of life. Cost-effectiveness analyses were also conducted.

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