cyrilzakka/clinical-trials huggingface dataset:
Development of a 3D Spacer Mattress for Pressure Relieving in Cardiac Surgery and Evaluation of Its Efficacy

In this study, researchers developed a mattress made of 3D spacer fabric to relieve pressure during cardiovascular surgery. Following the development process, an initial assessment of the mattress's effectiveness was carried out on healthy volunteers. The same people lay first on the developed product and then on the surgical mattress in the supine position. In both cases, the pressure between the person and the mattress was measured using a force-sensitive resistor (using Interlink's FRS-406 series sensors). Thirty patients were included in the initial evaluation. A randomised controlled trial was then carried out with patients undergoing surgery (patients were divided into two groups; (a) mattress developed by the researchers and (b) standard operating theatre mattress). Sixty patients were divided into two groups using block randomisation. In the block randomisation, patients below or above body mass index 27 were equally distributed between the groups. Pressure levels were measured continuously during surgery using the same sensors.

In this study, the researchers developed a mattress made of 3D spacer fabric for pressure relief during cardiovascular surgery. Following the development process, an initial assessment of the mattress's effectiveness was carried out on healthy volunteers. The same people lay first on the developed product and then on the surgical mattress in the supine position. In both cases, the pressure between the person and the mattress was measured using a force-sensitive resistor (using Interlink's FRS-406 series sensors). 30 patients were included in the initial evaluation. A randomised controlled trial was then carried out with patients who underwent surgery (patients were divided into two groups; (a) mattress developed by the researchers and (b) operating theatre mattress in common use). 60 patients were divided into two groups using block randomisation. In the block randomisation, patients below or above body mass index 27 were evenly distributed between the groups. Pressure levels were continuously measured during surgery using the same sensors. Data were analysed using IBM SPSS software v26.

Eligibility Criteria:
Inclusion criteria:

* Being 18 years or older
* Not having a pressure ulcer prior to surgery
* Agreeing to participate in the study

Exclusion criteria:

- Not agreeing to participate in the study.
Clinical Rescue Protocol - 2

The purpose of this study is to detect increasing medication dose results in heroin cessation for patients still using, to determine if decreasing medication dose in patients unable to tolerate medication dose increases retention, and to determine if blood levels of methadone or buprenorphine correlate with clinical response.


Eligibility Criteria:
Inclusion Criteria:

M/F ages 21-50. Opiate dependence according to DSM-IV criteria. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative-hynotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.
Fetal Brain Care: Therapies for Brain Neurodevelopment in Fetal Growth Restriction

Singleton pregnancies being diagnosed of fetal growth restriction from 24 to 32.6 weeks of gestation will be randomized to two equally sized groups: maternal oral supplementation with Lactoferrin and DHA (Docosahexaenoic acid) or placebo.

Randomized controlled trial among pregnant women that have been diagnosed of fetal growth restriction. These women will be randomized in order to evaluate the impact of maternal supplementation with Lactoferrin and DHA on the neurodevelopment outcome of their babies.

Main hypothesis: a prenatal intervention based on maternal supplementation with Lactoferrin and DHA improves neurodevelopment in fetal growth restriction.

Secondary hypothesis are that a prenatal intervention based on maternal supplementation with Lactoferrin and DHA in fetal growth restriction improves fetal growth and improves perinatal morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancies
* Non-malformed fetus
* Pregnancies with fetal growth restriction
* 24-32.6 weeks of gestation

Exclusion Criteria:

* Chromosomal or structural abnormalities diagnosed during pregnancy or in the neonatal period
* Critical Doppler study suggesting the need for delivery within the next 14 days at the time of diagnosis: reverse end-diastolic velocity in the umbilical artery or ductus venosus pulsatility \>95th centile
* Maternal mental or psychiatric disorders
* Maternal allergy to cow's milk protein
Robotic-arm Assisted 68 Ga PSMA PET/CT Guided Prostate Biopsy Versus MR Directed TRUS Guided Prostate Biopsy

The present study aimed to compare the diagnostic accuracy, radiation exposure, complication rates between 68Ga-PSMA PET/CT guided robotic arm assisted prostate biopsy and MRI directed TRUS guided prostate biopsy.

To compare the diagnostic yield of Robotic-arm assisted 68Ga PSMA PET/CT guided prostate biopsy and MRI directed TRUS guided prostate biopsy in patients with PIRADS grading 4/5.

To compare the visual pain index of the patients between two arms during the procedure.

To compare the complication rates between the two arms during and after the procedure for a period of 2 weeks

Eligibility Criteria:
Inclusion Criteria:

1. PIRADS 4 and 5 prostate lesions and PIRADS \</= 3 prostate lesions with high clinical suspicion.
2. Patients who are included in the study will be randomly allocated into either PSMA PET/CT guided biopsy or TRUS guided biopsy using simple randomization in RRApp

Exclusion Criteria:

1. Patients with acute prostatitis/ urine culture positive.
2. Patients with pre-existing bleeding diathesis like hemophilia, coagulopathy defined by INR ≥ 1.2, and Platelet counts ≤ 80,000/mm3
3. Patients who refuse to provide the written informed consent
4. Non-cooperative patients
Testosterone Undecanoate and Quality of Life of Men and Spouses

This study will be conducted as a prospective, single-center (multiple clinics), single-arm open phase IV study.

the study will follow hypogonadal patients, and aimed to confirm the hypothesis that testosterone undecanoate improves the patient satisfaction and quality of life, with parallel improvement in their spouses's quality of life and satisfaction. Each patient/spouse will serve as his own control.

the study protocol will follow hypogonadal patients, who initiate treatment with testosterone undecanoate, given in accordance with the standard protocol.

Hypogonadal men eligible for treatment with testosterone undecanoate, who have not been treated with testosterone undecanoate within the last 6 months prior to enrollment, can be enrolled in the study. Patients who were treated with another testosterone formulation (eg. testosterone gel, testosterone enanthate injections) will require a 4 week wash-out period. Patients must be enrolled after the decision for treatment with testosterone undecanoate has been made.

Patients will be followed for an observation period of 28 weeks. Observations will be recorded at 3 consecutive visits, and will assess patient and spouse satisfaction and quality of life with validated questionnaires.

The study design is an intra-individual comparison. Each patient/spouse serves as his own control.

a laboratory test for total testosterone level will be required in the last visit. the need for concomitant phosphodiesterase-5 inhibitors use will also be recorded and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Hypogonadal patient age 40 to 80 who has newly been prescribed testosterone undecanoate.
* The patient must be in a stable (\>3 months) heterosexual relationship to be eligible for the study
* Diagnosis of hypogonadism at the discretion of the physician, based on patient's symptoms and a laboratory evidence of T levels below 12 (symptomatic patients with borderline levels of 8.4 to 12 are also eligible for testosterone replacement therapy)
* Wash-out of 6 months for testosterone undecanoate, 4 weeks for other testosterone formulations, before study entry.
* Patient \& spouse must be capable and willing to fill-in questionnaires to be enrolled in the study
* Informed consent is required

Exclusion Criteria:

* The standard contraindications and warnings of treatment with testosterone replacement therapy, and specifically testosterone undecanoate, must be followed. Contra-indications as copied from the product prescribing information are: androgen-dependent carcinoma of the prostate or of the male mammary gland; past or present liver tumors; hypersensitivity to the active substance or to any of the excipients
* Men with desired paternity will be excluded
The Relationship Between ALDH2 and Aortic Dissection

The purpose of this study is to evaluate the impact of ALDH2 Glu504Lys polymorphism on aortic dissection.


Eligibility Criteria:
Inclusion Criteria:

* Chinese Han people diagnosed with aortic dissection in Qilu Hospital

Exclusion Criteria:

* Aortic dissection based on trauma, connective tissue diseases and pregnancy
* Patients with tumor
* Patients with no written consensus
A Retrospective Study of EGFR-TKIs,Gefitinib, Erlotinib and Osimertinib in NSCLC Patients Treatment

For patients of advanced NSCLC (non small cell lung cancer) , Individualized cancer therapy has been widely accepted since the success of crizotinib administration based on EML4-ALK fusion gene detection and gefitinib and erlotinib administration based on EGFR-TKIs sensitive mutations.From clinical points of view ,individual differences often occur between different patients, leading diverse effect in ADR and drug effect.Meanwhile ,the drug effect and adverse drug reaction was significantly influenced by the pharmacokinetic factors and pharmacodynamic factors.In this research ,we try to establish a more sensitive method to detect sensitive mutations in plasma and discover the correlation between somatic and germline mutations , trough concentration and EGFR-TKI drug effect, the association between ADME-associated SNP ,trough concentration and EGFR-TKI adverse effect .Furthermore, in vivo and in vitro research is also crucial for rational explanation for these clinical phenomenon.

The ADME-associated SNPs included are CYP3A4,CYP3A4,CYP1A1,CYP2D6, ABCB1,ABCG2 and so on .The somatic mutations included are EGFR ,K-RAS ,ALK and so on

Eligibility Criteria:
Inclusion Criteria:

The main patient entry criteria included: age≥ 18 years ; histologically and cytologically proved NSCLC; Eastern cooperative oncology group performance status (ECOG PS)≤2; adequate hematological , renal, and hepatic functions. Exclusion Criteria:

uncontrolled systemic disease ,any evidence of clinically active interstitial lung diseases, and other chemotherapy at the time of inclusion. The protocol was approved by the Ethical Committee of Cancer Center of Sun Yat-Sen University (CCSU), and written informed consent was obtained form each patient.
Ramelteon for Insomnia Comorbid With Asthma

This trial will test the efficacy and safety of ramelteon, a selective melatonin agonist, on patients with insomnia comorbid with asthma.

Subjects with insomnia comorbid with asthma will be randomized to placebo or ramelteon at night for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 - 60 with both insomnia and asthma.
* Insomnia:

  * a complaint of difficulty initiating sleep, difficulty maintaining sleep, or waking up too early or sleep that is chronically nonrestorative or poor in quality,
  * the sleep difficulty occurs despite adequate opportunity and circumstances for sleep, and
  * at least one form of daytime impairment related to the nighttime sleep difficulty must be present. The sleep complaint should be present on most days for at least 3 months.
* Additional inclusion criteria include: a subjective TST \<6.5 h and a subjective SL \> 45 min per night; a mean LPS \>20 min over 2 consecutive nights by polysomnography (neither night could have been \<15 min); a habitual bedtime between 10 PM and 1 AM; and ISI score \> 10 (based on 0-4 scale). LPS is defined as amount of time to the first 10 minutes of continuous sleep.
* Asthma will be diagnosed based on suggestive clinical history and either

  * airway hyperresponsiveness indicated by a 20% or greater decrease in FEV1 in response to inhalation of methacholine at 8 mg/mL or less
  * bronchodilator-responsive expiratory airflow limitation (if FEV1 \< 70% of predicted value or \< 1.5 L, improving ≥200 mL and 12% in response to 180 µg of albuterol aerosol). In addition to the above criteria, patients should have well-controlled asthma as evidenced by ACQ score \< 1.5.

Exclusion Criteria:

* Primary sleep pathology, other than insomnia as assessed by sleep history and confirmed by polysomnography to exclude significant sleep apnea (RDI \> 15), periodic leg movements (movement arousal index \> 15), REM behavior disorder; or circadian sleep-wake disorders
* History of cognitive or other neurological disorders;
* History of DSM-IV criteria for any major psychiatric disorder, including mania or alcohol or substance abuse;
* Depressive symptoms as assessed by the CES-D. Subjects with a score of 22 or greater indicates that the person may be suffering from a major depression and therefore, will be referred to their physician;
* Unstable or serious medical conditions;
* Current, or use within the past month, of psychoactive, hypnotic, stimulant or analgesic medications (except occasionally);
* Shift work or other types of self imposed irregular sleep schedules;
* Obesity (BMI \> 35 Kg/m2); or
* Pregnancy or desire to become pregnant during the study.
Effect of Educational Video in the Student's Knowledge

Supervise dental conditions and teach the procedure of oral hygiene are the responsibility of the nurse. Patients on chemotherapy have risk for oral and systemic changes factors. The investigators will evaluate the cognitive and procedural knowledge about oral hygiene and the relevance of the learning experience importance.

METHODOLOGY:

-Quasi-experimental research study, before and after an intervention, which was used in the educational video as a strategy for teaching about oral hygiene .

INSTRUMENTS:

1 ) tool to identify socio- demographic variables ( age, gender ),

2) scale (zero to ten) to assess the relevance of the student attaches the oral hygiene of people undergoing chemotherapy ;

3 ) instrument composed of true or false statements related to knowledge about oral hygiene for people undergoing chemotherapy,

4) instrument contemplating steps that should be used for oral hygiene of the patient and the structures escovadas6 ; contains a list of steps to observation record the implementation of the technique of brushing teeth , use mouthwash and floss;

5 ) rating scale the degree of acceptance of the use of video as educativa.7 the student carried out the technical strategy in itself ( before and after video ) , demonstrating how a patient undergoing chemotherapy should perform this technique .

The estimate for the subject's participation in research time was approximately 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

-Students in the fourth year of the Bachelor and the fifth year of undergraduate School of Nursing of Ribeirão Preto, University of São Paulo - USP

Exclusion Criteria:

-Desire to withdraw consent for the study procedures
Research on Emissions, Air Quality, Climate and Cooking Technologies in Northern Ghana

REACCTING (Research on Emissions, Air quality, Climate, and Cooking Technologies in Northern Ghana) is an interdisciplinary randomized cookstove intervention study in the Kassena-Nankana District of Northern Ghana. The study tests two types of biomass burning stoves that have the potential to meet local cooking needs and represent different "rungs" in the cookstove technology ladder: a locally-made, low-tech Gyapa rocket stove and the imported, highly efficient Philips gasifier stove. Intervention households were randomized into four different groups, three of which received different combinations of two improved stoves, while the fourth group serves as a control for the duration of the study. Diverse measurements assess different points along the causal chain linking the intervention to final outcomes of interest. The investigators assess stove use and cooking behavior, cooking emissions, household air pollution and personal exposure, health burden, and local to regional air quality. Integrated analysis and modeling will tackle a range of interdisciplinary science questions, including examining ambient exposures among the regional population, assessing how those exposures might change with different technologies and behaviors, and estimating the comparative impact of local behavior and technological changes versus regional climate variability and change on local air quality and health outcomes.


Eligibility Criteria:
Inclusion

Individual Participants:

* Classified as "rural"
* Uses biofuel as main cooking fuel source (firewood, animal waste, crop residue/sawdust)
* Uses borehole as main water source (to facilitate social network analysis linking household's knowledge and attitudes toward stoves to experience of social contacts);
* Does not have electricity (to permit possible addition of lighting intervention at a later date);
* Has a woman in household aged 18-55 and at least one child under five (since women and children are the most vulnerable to cookstove smoke and are thus the main focus of our health measures).

Clusters:

* No more than 25% classified as urban
* Accessible year-round (determined by field staff)
* Having at least 10 eligible households (in line with the participant criteria above)

Exclusion:

* Household could not be located
* Household declined to participate
Placebo and Active Controlled Study to Compare the Efficacy of Aspirin and Paracetamol in Treatment of Sore Throat Associated With a Common Cold

The purpose of this study is to determine the efficacy and safety of 1000 mg Aspirin (study medication) by comparing 1000 mg Paracetamol (study medication) in treating the symptoms of sore throat associated with a common cold. The study is designed to develop a treatment method against sore throat associated with a common cold which will have more advantages for patients than the methods that are currently available.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients
* Onset of common cold within the past 5 days
* Current sore throat
* Confirmed presence of a tonsillo-pharyngitis

Exclusion Criteria:

* Hypersensitivity to acetylsalicylic acid, salicylates, paracetamol, or any other NSAID
* Pregnant or lactating women
* History or acute state of peptic ulceration or gastrointestinal bleeding
* History of bleeding tendency
* History of asthma
* Inability to breathe through the nose or a history of chronic mouth breathing
* Other exclusion criteria may apply
Center for Stroke Disparities Solution - Community Transitions Intervention

The Stroke CTI study is a 3 arm randomized, controlled trial designed to assess the effectiveness of a nurse practitioner (NP) only and a NP and health coach (HC) community transitions intervention (CTI) in reducing secondary stroke risk by helping patients lower their systolic blood pressure.

Targeted study participants are Black and Hispanic patients with a history of stroke and a current systolic blood pressure (BP) above JNC7 recommended range (\>=140 mmHg) who recently entered home care service. The NP only program will provide a 30 day intervention while the NP/HC team will provide 3 months of support via in-home and telephone encounters for patients randomized to one of these groups. In the first 30 days post-enrollment the NP will focus on medical case management and coordination with primary care providers and specialists, provide self-management coaching, and intervene if gaps in care are identified - all with a focus on BP reduction and preparing the patient for ongoing BP maintenance. As applicable, the HC will pick up the case after 30 days and follow up with the plan of care jointly established by the patient, NP and HC. The focus will be on ongoing self-management coaching, providing preparation support for physician visits, and linking patient to additional community resources, as needed.

Eligibility Criteria:
Inclusion Criteria:

* Newly admitted to the VNSNY post acute care program
* 21 years of age or older
* Black and/or Hispanic
* Speaks English or Spanish
* History of stroke or transient ischemic attack (TIA)
* Hypertension diagnosis
* Average screening systolic BP \>= 140 mmHg
* Is available to participate in intervention activities during the study timeframe if randomized to treatment group

Exclusion Criteria:

* Dialysis
* End stage renal disease
* Kidney transplant
* Severe heart failure
* Significant cognitive impairment. Unable to provide informed consent, accurate self-report, and/or unable to participate effectively in intervention
* Significant verbal speech impairment. Unable to participate in intervention telephone sessions
* Patients with upper arm circumference outside of valid use parameters for the automated device used for eligibility screening
Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Metastatic Testicular Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, ifosfamide, and cisplatin in treating patients who have metastatic testicular cancer that has recurred following treatment.

OBJECTIVES:

* Determine the feasibility of combining paclitaxel, ifosfamide, and cisplatin induction in patients with metastatic nonseminomatous germ cell tumor of the testis in first relapse following first line treatment with bleomycin, etoposide, and cisplatin.
* Determine the response rates to this regimen in these patients

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours and ifosfamide IV and cisplatin IV daily for 5 days. Patients with stable or responding disease repeat treatment every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A minimum of 25 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Metastatic nonseminomatous germ cell tumor of the testis

  * In first relapse following first line treatment with bleomycin, etoposide, and cisplatin
  * Biopsy proven germ cell tumor OR
  * Rising tumor markers (alpha fetoprotein and/or human chorionic gonadotropin)
* No brain metastases

PATIENT CHARACTERISTICS:

Age:

* 16 to 64

Performance status:

* 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Glomerular filtration rate greater than 50 mL/min

Other:

* No other prior malignancy except curatively treated nonmelanomatous skin cancer or superficial bladder cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* No prior experimental drugs