cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Gabapentin vs. Placebo for Adjuvant Pain Control Following Acute Rib Fractures

A Multi-center, Randomized Controlled Trial of the Efficacy of Gabapentin vs. Placebo for Adjutant Pain Control Following Acute Rib Fractures.

Traumatic rib fractures are a tremendous source of pain which can limit respiratory function and overall recovery. Numerous multimodal pain management strategies have been employed with varying success; however, narcotics remain the mainstay of treatment. Beyond the acute side effects of narcotics, including altered mental status, depression of respiratory drive, and constipation, there is a substantial risk of long term dependency. Recently, loco-regional blockade and non-narcotic adjuncts have received increasing support within the literature. Gabapentin has been used extensively as a non-narcotic adjunct to analgesia regimens in the acute and chronic settings, however its ability to better control pain secondary to traumatic rib fractures has never been studied .

The primary aim is to assess the efficacy of gabapentin as an analgesic after rib fractures. Secondary aims are to assess the effect on pulmonary function and other known complications following rib fractures.

The hypothesis is gabapentin will improve pain control as measured by lower pain scores and lower narcotic needs. The investigators plan to test this hypothesis by recruiting trauma patients with rib fractures, and randomly assign them to gabapentin versus a placebo.

Eligibility Criteria:
Inclusion Criteria:

* \> 1 rib fractures
* Requiring hospital admission
* Enrolled within 24 hours of injury

Exclusion Criteria:

* Pregnancy
* Intubation
* Age \<18, age \>65
* Inability to tolerate PO medication
* Patient refusal
* Inability to obtain consent from patient or surrogate
* Renal or Hepatic impairment
* Allergy or Hypersensitivity to gabapentin or any component of the formulation
The Effect of Kinesio Taping in Pediatric Surgery

This study was planned to determine the effect of kinesio taping (KT) applied to the abdominal area after surgery on pain and gas output in children aged 6-12 years who had open appendicitis surgery.

It is stated that kinesio taping, alone or in combination, is an alternative application for the pain management of various disease and symptom processes. These sources state that kinesion relieves pain and makes movement easier. When the literature was examined, no study could be found examining the effectiveness of kinesio tape application in pain management and flatulence in the post-operative period in children who had appendicitis surgery. For this reason, this study aimed to examine the effect of kinesio taping applied to the abdominal area on pain and gas output after appendicitis surgery in children between the ages of 6-12.

Eligibility Criteria:
Inclusion Criteria:

* Open appendicitis surgery was performed,
* Are between the ages of 6-12,
* Conscious, literate and without hearing or speech problems,
* Children who do not have a mental disorder and agree to participate in the research will be included.

Exclusion Criteria:

* Exclusion Criteria:
* Do not apply analgesic treatment other than routine application.
* Patients who develop complications during the operation will be excluded from the study.
* Those with acute appendicitis or Angenesis appendicitis
Posture in Abdominopelvic Training in Women SUI

Measure effect of postural correction in abdominopelvic exercises on the improvement of the quality of life in patients with SUI. 42 women aged between 46-75 with SUI and stress-predominant mixed urinary incontinence. There were randomly assigned two groups of different treatment.

Quality of life was measured by questionnaires: Incontinence Questionnaire Short Form (ICIQ-IU-SF) and King's Health Questionnaire (KHQ) global punctuation and incontinence impact. Treatment satisfaction was measured by VAS scale.

The aim of this study was compare the effect of postural correction in abdominopelvic exercises on the improvement of the quality of life in patients with stress urinary incontinence (SUI).

Was a randomized 2-treatment parallel design study. The sample consist in 42 women aged between 46-75 with stress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (IUM). They were randomly assigned to two groups: Group 1 (n=21) who received abdomino-pelvic training, and Group 2(n=21) who received the above treatment, guidelines about postural correction.

Both groups received 12 treatment sessions in first session information regarding clinical and demographical aspects will be collected.

To evaluate results of postural correction combined with abdominopelvic exercise women was assessed:at initial session, post- intervention and 3 months post-intervention treatment.Quality of life was measured by spanish validation questionnaires: International Continence Questionnaire Short Form (ICIQ-IU-SF) and King's Health Questionnaire (KHQ) global punctuation and incontinence impact. Treatment satisfaction was measured by Visual analogic scale (VAS).

Eligibility Criteria:
Inclusion Criteria:

* SUI or stress-predominant mixed UI
* diagnosed via clinical assessment and urodynamic study
* Estrogenic deficit.: perimenopause, menopause, postmenopause

Exclusion Criteria:

* grade 3-4 prolapse,
* functional alterations (Barthel Scale \> 85 points),
* neurological or cognitive alterations (mini mental examination \> 24 points)
* other predominant type of urinary incontinence.
Open-label Study to Evaluate Metreleptin in Children Under 6 Years of Age With Generalised Lipodystrophy

This is an open-label, Phase 3b study to evaluate effectiveness, safety and pharmacokinetic parameters of metreleptin in patients under 6 years of age with generalised lipodystrophy and associated diabetes mellitus and/or hypertriglyceridaemia


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Generalised Lipodystrophy
* Metreleptin treatment naive

Exclusion Criteria:

* Weight \<9 kg at Screening (Visit 1)
THIS-WIC Telehealth Solutions: Evaluation With North Carolina WIC Clients

With funding through the United States Department of Agriculture (USDA) and Tufts University's Telehealth Intervention Strategies for WIC (THIS-WIC) project, North Carolina (NC) WIC department will be implementing new, nutrition education telehealth in NC's WIC program. The purpose of this study is to evaluate the impact of the telehealth platform. The evaluation will focus on NC WIC clients as the study population. The North Carolina WIC department would be implementing this education platform, regardless of the evaluation research. The North Carolina WIC department is responsible for implementing this new intervention, while the Tufts University research team is responsible for the evaluation of this platform through surveys and analysis of administrative data.

An online survey will be used to gauge WIC clients' satisfaction with the telehealth solution and the impact of the telehealth solution compared to usual care on breastfeed duration, dietary intake, attendance at scheduled appointments, attitudes to breastfeeding and nutrition education, and barriers encountered. Survey data will be combined with previously collected data on clients and their families from the NC Management Information Systems (MIS), and aggregate level data from the telehealth solution about utilization.

Telehealth can reduce barriers and increase access to care, and it can be applied to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). WIC is a federal nutrition assistance program that helps low-income women with children up to age 5. There is a large volume of research that supports remote patient monitoring, and the most benefits are found when telehealth is used for communication and counseling. The USDA awarded Tufts University a grant to test and evaluate the use of telehealth innovations in the delivery of USDA's WIC program. Tufts University then offered the USDA/Tufts Telehealth Intervention Strategies for WIC (THIS-WIC) grant opportunity to WIC state agencies across the US. THIS-WIC selected 7 WIC State Agencies to receive grants, and the NC state agency is one recipient. The THIS-WIC team at Tufts University is leading the evaluation of these telehealth solutions in collaboration with funded WIC State Agencies.

THIS-WIC aims to generate evidence from NC's telehealth solution to inform how the telehealth solution supports WIC services compared to usual in-person care. The NC telehealth platform includes a mobile-optimized website, meaning that it functions as an app without requiring the amount of memory and data that apps use. Evaluation findings will inform stakeholders about the platform's benefits and how viable it is to sustain and adapt more widely.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women
* postpartum women
* parent/guardian of a participating infant or child in the WIC program

Study participants will be clients at local WIC agency sites where either the telehealth solution is offered or where only usual care is available (control).

Exclusion Criteria:

-
Electrocardiography Versus Pulse Oximetry for Newborn Heart Rate Determination

The goal of this study is to compare the time required for accurate heart rate measurement of the preterm newborn when using pulse oximetry versus electrocardiography leads.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age of 24-32 weeks

Exclusion Criteria:

* Babies with open abdominal defects
New Combination Regimen of L-asparaginase, Dexamethasone, Ifosfamide, Cisplatin and Etoposide in NK/T-Cell Lymphoma

The purpose of this study is to evaluate the efficacy and tolerability of the combination chemotherapy of L-asparaginase plus DICE regimen in the patients with early stage NK/T-cell lymphoma.

DICE regimen was found to be highly effective as induction chemotherapy in patients with early stage NK/T-cell lymphoma in the ongoing study. L-asparaginase, an agent with unique anti-cancer mechanism, was also found to be effective in salvage setting. In terms of non-overlapped efficacy and toxicity, the investigators designed this phase II study to verify the efficacy and tolerability of this new combination.

Eligibility Criteria:
Inclusion Criteria:

* Age range 14-75 years old
* Histological confirmed, previously untreated stage I/II NK/T cell lymphoma in the upper-aerodigestive tract
* ECOG performance status less than 2
* Life expectancy of more than 3 months
* Normal laboratory values: hemoglobin \> 80 g/dl, neutrophil \> 2×109/L, platelet \> 100×109/L, serum creatine \< 1.5×upper limitation of normal (ULN), serum bilirubin \< 1.5×ULN, ALT and AST \< 2.5×ULN

Exclusion Criteria:

* Pregnant or lactating women
* Serious uncontrolled diseases and intercurrent infection
* The evidence of CNS metastasis
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
Voluntary HIV Counseling, Testing, and Medication for Pregnant Women to Prevent Mother-to-Child HIV Transmission

Voluntary HIV counseling and testing (VCT) and anti-HIV drugs for pregnant women and their newborns decrease rates of mother-to-child transmission (MTCT) of HIV. This study will determine the acceptability of HIV counseling and rapid testing prior to delivery and will compare the usefulness of VCT prior to birth versus after birth in preventing MTCT of HIV in pregnant women in Cape Town, South Africa. This study will also determine the acceptability and effectiveness of giving anti-HIV medications to prevent MTCT of HIV.

Pediatric HIV infection is a major public health problem in South Africa, and is primarily caused by MTCT of HIV. Strategies to prevent MTCT have been successfully employed when a mother's HIV status is known. However, there is concern in South Africa that it is unethical to offer HIV testing to women in the intrapartum period when they are experiencing the physical and emotional stress of labor. This study will compare the acceptability and accuracy of intrapartum and postpartum VCT in pregnant women of unknown HIV status in Cape Town, South Africa.

Pregnant women of unknown HIV status coming to a participating hospital to deliver will be asked to enter the trial. Women will be assigned to either intrapartum or postpartum VCT depending on the week during which they come to the hospital. The intervention (intrapartum or postpartum VCT) for the week will be randomly assigned and all women enrolling in the trial in a given week will receive the same intervention.

All women will receive HIV counseling prior to testing. Women in the intrapartum VCT group who are HIV infected will receive antiretrovirals (ARV) prior to delivery to prevent MTCT, and their infants will receive ARV within 3 days of birth. Infants born to HIV infected women in the postpartum VCT group will receive ARV as soon as possible after confirmation of the mother's positive test. All women will receive post-test counseling prior to discharge.

HIV VCT, medical history assessment, and physical exam will occur at study entry. A small subset of both HIV infected and uninfected mothers will be asked for their opinions regarding peripartum HIV VCT and MTCT prevention strategies during qualitative assessments.

Infants will undergo physical exam within 2 days of birth, medical history assessment within 2 days of birth and at 3 additional times between 6 and 14 weeks of age, and HIV testing within 2 days of birth and at 2 additional times between 6 and 12 weeks of age.

Eligibility Criteria:
Inclusion Criteria for Women:

* Unknown HIV infection status
* At least seven months pregnant
* Women in active labor who have planned induction or Caesarean delivery or any other condition requiring planned delivery

Inclusion Criteria for Infants:

* Mother is participating in study
* Mother is HIV infected

Exclusion Criteria for Women:

* Women in labor who need immediate delivery
* Obstetrical emergencies in which the woman is medically unstable or requires emergency delivery
* Diagnosed fetal death or fetal condition requiring abortion
Clinical Assessment of Barley and Oat Phytochemicals

The goal of this placebo-controlled, 3-way crossover study is to determine the acute (24-h) bioavailability and pharmacokinetics of the major phytochemicals found whole barley and oats, as well as their effects on selected measures of antioxidation, inflammation, insulin sensitivity/glucose regulation, and vascular remodeling following challenge by an oral glucose tolerance test (OGTT).


Eligibility Criteria:
Inclusion Criteria:

* Men and postmenopausal women
* BMI 27-35.9 kg/m2

Exclusion Criteria:

* Cigarette smoking and/or nicotine replacement use
* Individuals taking estrogen
* Use of cholesterol-lowering medications
* Use of blood pressure-lowering medications
* Regular use of any stomach acid-lowering medications or laxatives (including fiber supplements)
* Cardiovascular (heart) disease
* Gastrointestinal disease
* Kidney disease
* Endocrine disease: including diabetes, untreated thyroid disease
* Rheumatoid arthritis
* Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
* Systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 95 mmHg
* Regular use of oral steroids
* Regular daily intake of ≥ 2 alcoholic drinks
* Infrequent or excessive number of regular bowel movements
* Illicit drug use
* Vegetarians
* No fish oil supplements (including cod liver oil) for one month prior to study admission
* No dietary supplements, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) or homeopathic remedies, for one month prior to study admission
A Comparison of Dendritic Cell Content and T-Cell Phenotype Between Granulocyte Colony-Stimulating Factor (G-CSF) or G-CSF + Granulocyte Macrophage (GM)-CSF

This is a study involving patients who are undergoing allogeneic peripheral blood stem cell transplantation. Both donors and recipients are being sought for this study.

Patients with leukemia will receive a stem cell transplant, prior to which they will receive medication and/or radiation to destroy all leukemia cells as well as other blood cells. In order to survive this treatment, patients will need to be given the stem cells from another person to replace the blood cells killed by the treatment.

The stem cells given to the recipient will be collected from a relative. To increase the number of stem cells in the relative, he/she is given a growth factor to increase the number of stem cells prior to collection. The standard growth factor used is called G-CSF(Granulocyte Colony-Stimulating Factor ). In this research study, the physician will give the relative either G-CSF or a combination of G-CSF and GM-CSF (Granulocyte Macrophage (GM)) , another type of growth factor. Whether the relative receives G-CSF or GM-CSF will be determined by chance. The donors will be randomized to one or the other. It is not known if the stem cells and white blood cells collected using one or both growth factors results in more cures for this disease and fewer side effects, such as graft-versus-host disease.

The reason for doing the study is to determine if the stem cells and other white blood cells collected are any different when different growth factors are given, and to see how well the patient does. The stem cell transplant will in every other way be the same. The only difference is that if the recipient and donor decide to be in this study, the donor will either be given only G-CSF or the combination of G-CSF and GM-CSF and the recipient will receive the stem cells collected.

Eligibility Criteria:
Inclusion Criteria:

* All normal donors for patients undergoing allogeneic peripheral blood stem cell (PBSC) for hematologic diseases will be invited to participate in this research trial.
* All patients must meet criteria for transplantation.
* Final eligibility will be determined by the health professionals conducting this clinical trial.

Exclusion Criteria:

* Donors for patients undergoing selected or manipulated PBSC grafts are not eligible.
* Donors who are pregnant or lactating females and donors with a known hypersensitivity to either G-CSF or GM-CSF will be excluded from this study.
* Final eligibility will be determined by the health professionals conducting this clinical trial.
Health Coaching Based Treatment Versus Usual Treatment of Systemic Arterial Hypertension and Comorbidities

Hypertension is a multifactorial clinical condition, it may not cause symptoms and its diagnosis is often delayed. And even when it is diagnosed early, some patients cannot manage an adequate blood pressure.

There are several hypotheses for the non-control of blood pressure, among them the difficulty of lifestyle change, irregular treatment with antihypertensive drugs, non-individualized treatment. Studies haven shown that tools such as multiprofessional team and hypertension leagues are important strategies to obtain a better outcome in the hypertension treatment, but new approaches are still necessary. Health Coaching is an individualized form of follow-up, promoting better adherence, better nutrition, smoking cessation, regular physical exercise and regular use of drugs, thus reducing cardiovascular mortality.

Drug adherence and lifestyle changes are tools for chronic disease control. The relationship between nutrients, alcohol intake, and weight change in blood pressure was demonstraded in one study, demonstrating the importance of lifestyle change. Studies have shown that multiprofessional team and hypertension leagues are important strategies to obtain a better outcome, but new approaches to the patient are still necessary. Health coaching is an individualized follow-up, promoting better adherence to the hypertension treatment. Health coaching is a new model based on the support of the individual, for a better autonomy in personal care. The process engages de patient with the conditions of the disease itself by increasing knowledge, skill and confidence so that the patient become informed, active in the participation of its own care. Among health care, training is characterized by the expression. Of concerns, answering questions, providing information on home-based follow-up, and collaborative development of health care plans.

Motivated patients are more likely to treatment adherence and more committed to making lifestyle changes and thus effectively managing their illness.

The research is a randomized clinical trial comparing treatment based on health coaching and the usual treatment based in the treatment of hypertension and comorbidities in uncontrolled hypertensive patients.

Eligibility Criteria:
Inclusion Criteria:

* Blood pressure above 160/90mmHg
* Signed the free and informed consent form
* Regularly enrolled, with at least two visits in the last 12 months

Exclusion Criteria:

* Miss the subsequent consultation
* Those who have not signed the free informed consent form.
Nutritional Assessment of Hospitalized Patients With COVID-19

The nutritional consequences of the infection by the SARS-CoV-2 are as follows:

* A severe respiratory infection induces an inflammatory syndrome and hypercatabolism, as well as an increase in energy expenditure related to ventilatory work; nutritional requirements (calories and protein) are therefore increased.
* Food intake is often reduced by several factors: anorexia secondary to infection, respiratory discomfort, anosmia, ageusia, obesity, stress, confinement, organizational problems limiting meal assistance.

Then, it is important to asses the nutritional status of COVID patients hospitalized in conventional COVID units (excluding intensive care).


Eligibility Criteria:
Inclusion Criteria:

* Patient on conventional hospitalization (duration less than 72 hours)
* Age \> 18 years old
* COVID 19 diagnosed by Real Time Polymerase Chain Reaction (RT-PCR)
* Patient agreed to participate in the study
* Patient affiliated to French social security

Exclusion Criteria:

* Patient hospitalized in intensive care units during more than 72 hours