cyrilzakka/clinical-trials huggingface dataset:
A Stitch in Time May Save Lives: Turning Poor Bednets Into Good Ones

Although the use of mosquito nets has increased in Africa, many of the nets used are in a poor state, and not an effective barrier against mosquitoes. This pilot study examines whether subsistence farmers in rural Africa can be encouraged to repair their mosquito nets and use their bednets appropriately. Attitudes and practises on sewing and net use were examined in The Gambia and an intervention developed to promote net repair. Songs and posters were used to emphasise the importance of repairing nets and their correct use, and served as aural and visual reminders to repair nets now rather than postpone this household chore. The intervention was aimed at effectively and cheaply turning a poor net into a good one.

Sleeping under an insecticide-treated net protects the sleeper from mosquito bites and is highly effective means of reducing the risk of malaria. Recent studies in The Gambia and Kenya have shown that untreated bednets in good condition can also protect against malaria (51% protection against parasitaemia, 95% CIs 34-64%). However, most children in rural Gambia sleep under untreated nets in poor condition, often with a few holes, and do not close their nets properly at night. These children remain exposed to mosquito bites and the risk of malaria.

This pilot study examines whether subsistence farmers in rural Africa can be encouraged to repair their mosquito nets and use their bednets appropriately. Attitudes and practises on sewing and net use were examined in rural Gambia and an intervention developed to promote net repair. Songs and posters were used to emphasise the importance of repairing nets and their correct use, and served as aural and visual reminders to repair nets now rather than postpone this household chore. The intervention was aimed at effectively and cheaply turning a poor net into a good one.

The intervention was developed and implemented in two neighbouring villages in The Gambia, with each village composing their own songs. There was no formal control village. An internal comparison group was used in which the nets of responders and non-responders living within the same village were compared.The success of the intervention was assessed by: recording the number of nets repaired and used correctly for malarial prevention before and after the intervention; by counts of mosquitoes entering the nets classified according to number of holes and degree of repair; as well as by canvassing participants' opinions.

Eligibility Criteria:
Inclusion Criteria:

* Community consent
* Willingness to participate in study

Exclusion Criteria:

* None
Effect of Charcoal on Gastrointestinal Absorption of Tiotropium

The study will assess how efficiently activated charcoal will block absorption of tiotropium via the gastro intestinal track. Pharmacokinetics of tiotropium will be compared after orally administered tiotropium capsule with and without concomitant activated charcoal administration in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent (IC) obtained.
2. Healthy males and females, aged 18-60
3. Normal weight at least 50 kg.

Exclusion Criteria:

1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
2. Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
3. Any clinically significant abnormal laboratory value or physical finding that may interfere the interpretation of study result or constitute a health risk for the subject if he/she participates in the study.
4. Known hypersensitivity to tiotropium bromide, atropine or its derivatives or to the excipients of the drug.
5. Pregnant or lactating females.
6. Females of childbearing potential not using proper contraception.
The Relationship of Core Endurance With Cervical Stabilization and Proprioception in Women With and Without Pilates Exercise

The aim of this study was to investigate the relationship between core endurance and cervical stabilization and proprioception in women with and without Pilates exercise. The study was conducted with 40 volunteer female participants aged 20-50 years. The study group was selected from women who did Pilates exercises 2 days a week for at least 12 weeks under the supervision of a physiotherapist, while the control group was selected from women who did not participate in any Pilates, yoga or exercise program in the last 1 year and were sedentary according to the International Physical Activity Questionnaire. Lateral Bridge Test, Static Trunk Extension Test, Trunk Flexor Endurance Test, Cervical Joint Position Error Test, Cervical Region Deep Flexor Muscle Endurance Tests were applied to the participants and Craniocervical Flexion data of the participants were evaluated with Stabilizer Pressure Biofeedback Device and the results were recorded. These results indicate that high performance in core endurance is associated with improved performance in cervical stabilization. As a result of this study, it was concluded that Pilates has a significant effect on core endurance, cervical stabilization and proprioception in women.


Eligibility Criteria:
Inclusion Criteria:

* Being between 20-50 years old
* Volunteering to participate in the study
* Having practiced Pilates at least 2 days a week for at least 12 weeks for the study group
* For the control group, not having participated in any pilates, yoga or exercise program in the last year and being sedentary according to the International Physical Activity Questionnaire

Exclusion Criteria:

* Presence of pain during assessments
* Cervical and/or lumbar disc herniation
* Spine pathology
Evaluating Placental Thickness and Thickness of Uterine Muscle at Placenta Attachment in Prediction of Postpartum Blood Loss

Aim of the Work is To determine the significance of the placental thickness and the thickness of the uterine muscle layer at placenta attachment in the prediction of postpartum hemorrhage and to evaluate both of them as as parameters for identifying high-risk patients.

PPH remains the most common cause of maternal mortality all over the world

PPH is a serious complication ) is a serious complication of labor and delivery with an incidence of approximately 5-10% and a mortality rate 0.5:1%

PPH can also be a cause of long-term severe morbidity and approximately 12% of women who survive PPH will have severe anaemia A significant percentage of deaths due to PPH can be due to a lack in assessing bleeding amount. Clinically assessing bleeding through inspection underestimates the actual bleeding volume and depending on haemodynamic abnormalities may be to late as effective countermeasures are often not taken in time so identifying pregnant women at risk of PPH prior to delivery is crucial to prevent PPH .

The leading cause of PPH is thought to be uterine atony - the failure of the uterus to contract fully after delivery of the placenta. PPH resulting from uterine atony is a major preventable cause of maternal morbidity and mortality, especially in developing countries .(B-Lynch et al., 2006)

Risk factors for PPH and its main causes, including weak uterine contractions, birth canal lacerations, placental factors, and coagulation abnormalities have been relatively well studied .

However the effect of placental attachment on the thickness of the myometrium and its correlation with PPH is not well studied . By exploring the potential correlation between thinner myometrium at the placenta and a higher incidence of PPH we can reduce mortality occuring with PPH. this study highlight the significance of evaluating the impact of placental attachment on myometrial thickness and placenta thickness in the context of PPH

The study will be carried out on 150 pregnant women, who will undergo delivery at benha university hospital either by vaginal delivery or cesarean section either as elective palnned at operative list or admitted to Obstetrics ER after complete clinical evaluation and decision taken by staff member of Benha gynecology and obstetrics department.

Informed consent will be obtained from all participants prior to commencing the study.

Eligibility Criteria:
Inclusion Criteria:

* Term pregnancy (37 wk gastation and more )
* Single viable fetus

Exclusion Criteria:

* Severe hematological disorders that could cause abnormal coagulation
* Placental implantation abnormalities or placental abruption
* Uterine anomalies, including congenital or acquired structural abnormalities.
* Previous history of PPH
* category 1 CS and category 2 CS
* Multiple pregnancy
* Preterm labour
* IUFD
Detection of Viral Particels in Urticaria Patients

Blood samples from urticaria patients will be analyzed for viral particles

After digestion with DNase to eliminate human DNA, RNA will be reversed-transcribed and amplified with random primer/ Amplification products will be pooled and sequenced/ After substruction of sequences of vertebrates and highly repetitive sequences, contiguous sequences will be assembled and compared with motifs represented in databases of viruses. which will enable identification of putative protein sequences consistent with viruses

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic spontaneous urticaria

Exclusion Criteria:

* none
The Efficacy of Penile Rehabilitation Using Udenafil After Total Mesorectal Excision of Rectal Cancer

Sexual dysfunctions are well-recognized complications after rectal cancer surgery. Damage to the pelvic plexus and pelvic splanchnic nerves results in ejaculatory dysfunction. The purpose of this study is to evaluate the efficacy of Udenafil(Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea) in penile rehabilitation for patients who undertake total mesorectal excision.


Eligibility Criteria:
Inclusion Criteria:

* Age : 20-65
* Rectal cancer within 15cm from anal verge
* Patients with more than 5 points decreased IIEF-5 after operation
* Patients with sexual activity

Exclusion Criteria:

* Preoperative IIEF-5 : ≤14
* Recent MI, CVA, nitrate medication
* Severe cardiovascular disease, psychiatric disease
* Severe hepatic dysfunction (GOT, GPT ≥100IU/L)
* Renal dysfunction (Cr ≥2mg/dl)
Genetics of Rolandic Epilepsy

The purpose of this study is to find the genes that cause Rolandic epilepsy and its related traits.

Rolandic epilepsy (RE) is the most common type of childhood epilepsy-affecting more than 50,000 children in the United States-and has a complex genetic inheritance. The seizure prognosis is relatively benign, however, many children with RE also have problems with speech and language, reading, and motor coordination. Symptoms of the disorder overlap with more severe types of epilepsy.

The purpose of this study is to find the genes that influence RE and its related traits. Identifying genetic causes for the variants would improve diagnosis and allow for early intervention.

Researchers will enroll 1000 children with RE and 3000 controls for participation in the study. The scientists will request medical histories and (salivary) DNA samples from the participants. Participation can be completed by mail and telephone.

Results from this study should provide important information regarding diagnosis and prognosis of RE, may be useful in clinical management, and, eventually, may lead to a cure for this and other forms of epilepsy.

Eligibility Criteria:
Inclusion:

* typical history of focal seizures
* EEG centrotemporal sharp waves
* age of onset 3-12 years
* no previous epilepsy type (febrile seizures OK)
* normal development
* normal neurological examination
* normal MRI/CT (if done)

Exclusion:

* only history of secondary generalized seizures
* atypical history/semiology
* history and EEG inconsistent
* abnormal EEG background
* very early (\<3yrs) or late (\>12yrs) onset
* global neurodevelopmental deficit
* deviant neurodevelopment
* structural imaging abnormality
Cystatin SN Binds to Phytic Acid and Predicts Non-heme Iron Bioavailability

Phytic acid is a known inhibitor of iron bioavailability, although long term studies have suggested possibly exaggerated findings compared to single meal studies, pointing to phytic acid adaptation over time. Salivary proline-rich proteins have been found to reduce tannin-iron chelation, but studies have not explored changes in salivary proteins that may result in phytic acid adaptation. The primary objectives of this study are: 1) To determine whether phytic acid impacts iron bioavailability or status when consumed over time 2) to test whether salivary protein production may impact iron bioavailability with phytic acid supplementation, and 3) to explore in vitro phytic acid salivary binding. Secondary objectives included assessment of the reliability of astringency as a measure of salivary protein production and iron absorption.

The study was conducted in an iron absorption study of 7 women, aged 18-35 years old, to determine iron bioavailability with supplementation of 350 mg phytic acid before and after regular, three times daily supplementation for four weeks. Direct iron absorption was measured using area under the curve. Iron status was measured by changes in hemoglobin and ferritin, and was adjusted by participant c-reactive protein levels. Salivary samples were collected before and after supplement consumption during meal challenges, and analyzed on HPLC and by ELISA. Astringency testing was conducted at the end of each meal challenge. In vitro saliva-phytic acid modeling was explored on HPLC, MALDI-TOF, and ELISA. Iron absorption and status markers were analyzed by ANOVA, and mixed-modeling followed by pairwise comparison by least significant differences. Pearson's correlations were used to correlated salivary proteins and astringency with iron bioavailability.

The present study will provide important information regarding the approximate influence of phytic acid consumption on iron bioavailability and storage over time in regards to salivary proteins. It will also give context to the role of salivary proteins with phytic acid consumption over time. Data will also help to delineate possible physiological mechanisms underlying phytic acid adaptation and possible ways to detect individuals who better adapt than others.


Eligibility Criteria:
Inclusion Criteria:

* Female, 18-35 years' old
* Non-obese BMI (18-29.9)
* Signed informed consent

Exclusion Criteria:

* Oral disease
* Gastrointestinal disease
* Tobacco user
* Heavy alcohol user
* Pregnancy (assessed by pregnancy test)
* Lactation
* Medications affecting iron bioavailability
* Vitamin or mineral supplementation (other than vitamin B12)
Pericardial Resection to Treat Heart Failure

The researchers are doing this study to find out whether there will be less increase in cardiac filling pressure after the surgeon opens the pericardium (the membrane around the heart) than when the pericardium is intact. The researchers want to see whether opening the pericardium is an effective way to reduce the blood filling pressures in the heart.

This study will enroll patients with risk factors for LV diastolic dysfunction, either coronary artery disease or aortic stenosis, who are already undergoing cardiac surgery for clinical purposes (e.g. coronary artery bypass grafting or valvular heart disease).

Hemodynamic tests will be performed using standard clinical resources used as part of routine care in this setting, including pulmonary artery (PA) catheterization. After obtaining written informed consent, patients will undergo induction with general anesthesia as per clinical practice. The chest will be open but pericardium left intact. Cardiac hemodynamics (PA wedge pressure, PAWP; PA pressure, PAP, right atrial pressure, RAP) will be measured using PA catheter already in place at rest, and then during conditions of increased cardiac preload, induced by passive leg elevation and saline bolus (300 ml administered over 1-2 minutes).

The surgical team will then perform anterior pericardiotomy, with removal of pericardial restraint similar to our percutaneous approach but using currently-available surgical tools. This will not be a complete pericardiectomy but rather a limited anterior incision to gain access to the heart for surgical exposure (standard care).

The surgical team will then repeat hemodynamic assessments at rest and with acute volume loading (leg raise + saline) in exactly the same manner as with the pericardium intact. Our hypothesis is that as compared to pericardium intact, the increase in PAWP with volume loading will be reduced following opening of the pericardium.

Eligibility Criteria:
Inclusion

* \>17 years old
* Subjects having open sternotomy for either aortic valve stenosis or coronary artery bypass grafting (or both)
* Provide informed consent Exclusion
* \<18 years old
Connected Catheter (C2P) Study for Bladder Management

The objective of this study is to evaluate the safety and essential performance of the C2P System in males with neurogenic lower urinary tract dysfunction (NLUTD), both in an acute clinical setting and an extended period of home use.

Spinal Singularity had developed C2P system to address several drawbacks of current standard-of-care urinary catheters. The C2P is fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization, including NLUTD. The C2P is a sterile, single-extended use device that resides fully internally to the male lower urinary tract for an intended service life of up to 29 days per catheter

Eligibility Criteria:
Inclusion Criteria:

1. Males age ≥ 18 with clinical diagnosis of neurogenic lower urinary tract dysfunction (NLUTD)
2. Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling strategy

   * Must have stable urinary management history: no significant changes in bladder management regimen within past 12 months

   OR:
   * Must have urodynamic profile suitable for C2P, as assessed via urodynamics study within past 12 months (including bladder capacity \> 200mL without uninhibited bladder contractions)
3. Subject's lower urinary tract anatomy must fall within the ranges serviceable by the C2P device, as specified in the investigational device instructions for use (IFU).

Exclusion Criteria:

1. Active symptomatic urinary tract infection, as defined in this protocol (subjects may receive the device after Urinary Tract Infection (UTI) has been treated)
2. Significant risk profile or recent history of urethral stricture (e.g. stricture within past 90 days)
3. Significant risk profile or recent history of clinically significant autonomic dysreflexia (AD) (e.g. History of hospitalization due to AD within past 12 months)
4. Significant intermittent urinary incontinence (between catheterizations)
5. Uninhibited bladder contractions and/or vesico-ureteral reflux that is not reliably controlled with medication or alternate therapy (e.g. Botox injections)
6. Pre-existing urinary pathologies and/or morphological abnormalities of the lower urinary tract or bladder (assessed during in-depth medical screening, including cystoscopy and urine analysis)
7. Urinary tract inflammation or neoplasm
8. Urinary fistula
9. Bladder diverticulum (outpouching) \> 5cm in size
10. Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months)
11. Impaired kidney function or renal failure
12. Active gross hematuria
13. Active urethritis
14. Bladder stones
15. Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted drug pump) or external device
16. Any unsuitable comorbidities as determined by the investigator or complications related to use of certain medications
17. Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the C2P System
Effect of Intense vs. Standard Hypertension Management on Nighttime Blood Pressure - an Ancillary Study to SPRINT

Hypertension is a major risk factor for cardiovascular and renal disease, and a leading cause of premature mortality worldwide. Early hypertension studies showed that treating elevated blood pressure (BP) reduces patients' risk of cardiovascular disease and all-cause mortality. In subsequent research, patients achieved greater improvement in cardiovascular outcomes when their treatment was aimed at a moderate systolic BP target (\<150mmHg) than at higher targets. Although observational data suggest that even lower BP targets may be beneficial, this has not been seen in randomized trials; instead, "intense" treatment of hypertension (i.e., to a target systolic BP \<120mmHg) was found to have no effect on participants' risk for renal disease, cardiovascular disease, or all-cause mortality.

One potential explanation for this apparent lack of benefit of intense BP targets is that the study protocols targeted reductions in clinic BP rather than ambulatory BP. Ambulatory BP monitoring (ABPM) allows for assessment of BP throughout the day and night. Of all the BP measurements, nighttime systolic BP appears to be the best predictor of cardiovascular disease and all-cause mortality. Because recent trials assessing intense BP targets did not include ambulatory BP measurements, the effect of intensive treatment on nighttime BP is largely unknown.

To address this important gap in knowledge, we will conduct ABPM in 600 participants as part of an ancillary study to the ongoing Systolic Blood Pressure Intervention Trial (SPRINT). The goal of the ancillary study is to evaluate the effect of intensive vs. standard clinic based BP targets on nighttime BP (primary outcome), as well as night/day BP ratio, timing of peak BP, 24hr BP, and BP variability (secondary outcomes). The SPRINT trial includes approximately 9250 participants at high risk for cardiovascular disease.

The investigators hypothesize that intense targeting of clinic systolic BP does not lower nighttime systolic BP compared to a standard target.


Eligibility Criteria:
Inclusion Criteria:

* eligible and enrolled in SPRINT at the 27 month follow up visit
* able and willing to provide informed consent

Exclusion Criteria:

* arm circumference \>50cm
* shift worker or work regularly at night
* history of breast cancer requiring mastectomy
* end-stage renal disease
CARE: A Prospective Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400

The primary objective of this study is to gather data on the radiation exposure in patients treated with the Penumbra Coil 400™ System (PC 400) or conventional coils per their respective indications for use.This is a multicenter case review study of patients presenting with intracranial aneurysms who are treated with coil embolization therapy using the PC 400 or conventional coils. Data for each patient are collected acutely.Up to 90 patients treated with the PC 400 or conventional coils (2:1) at up to 15 centers in the USA will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Patients enrolled in the PC 400 arm must be those treated according to the cleared indication for the PC 400 System, which includes endovascular embolization of intracranial aneurysms.
* Patients treated with conventional coils should be treated per their IFU.
* Adjunctive use of stents, balloons or liquid embolics, if considered appropriate by investigators, is allowed.

Exclusion Criteria:

* Pre-planned use of multiple coil systems and/or flow diverters.