Kornimate/medical-research-clean huggingface dataset:
neonatal package study in rural district of pakistan

Conditions: Neonatal Infections

Summary: neonatal mortality has been a notable health issue in pakistan. considering the importance of the issue and well recognized interventions the investigators are proposing a randomized controlled trial in a rural district of pakistan which will evaluate the effectiveness of a neonatal package comprised of the standard neonatal care, kangaroo mother care (kmc) and application of chlorhexidine compared with standard neonatal care coupled with application of chlorhexidine and essential neonatal care alone. the investigators anticipate that this study will provide an evidence base way forward benefiting the children of pakistan.

the global neonatal mortality burden is one of the imminent factors which derail the achievement of the mdg 4 in many developing countries including pakistan. four million infants infants die in their first 28 days of their lives which account for about 40% of the total under-five mortality. the burden of neonatal mortality in pakistan is alarming as the current neonatal mortality rate (nmr) is 55 per 1000 live births, third worst in the world. the major causes of these deaths are infections, preterm births and birth asphyxia which are avoidable. despite many initiatives the nmr remains unchanged since last decade in pakistan. literature shows that low cost facility and community based interventions can reduce nmr significantly. early neonatal care, application of chlorhexidine for cord care and kangaroo mother care (kmc) have been recognized as effective intervention in reduction of neonatal morbidity and subsequently neonatal mortality in many developing countries. however these interventions have never been tested as a package and data about their combined effect is scarce both in pakistan and developing countries. considering the importance of the issue and well recognized interventions we are proposing a randomized controlled trial in a rural district of pakistan which will evaluate the effectiveness of a neonatal package comprised of the standard neonatal care, kmc and application of chlorhexidine compared with standard neonatal care coupled with application of chlorhexidine and standard neonatal care alone. we anticipate that this study will provide an evidence base way forward benefiting the children of pakistan.

Eligibility criteria:
inclusion criteria: * all healthy newborns born in the study settings will be systematically enrolled in the trial after prior consent. exclusion criteria: * infants with congenital/birth defects, * any localized infection on the peri umbilical region at the time of birth or application of * any other material such as dung etc before enrollment on the cord.

Keywords: chlorhexidine kangaroo mother care rct
specimen repository for hiv immunopathogenesis

Conditions: HIV-1-infection; Acute HIV Infection

Summary: specimen repository for hiv immunopathogenesis studies

the goal is to build a large specimen repository for collaborating scientists to run studies of immunity and hiv-1.

Eligibility criteria:
inclusion criteria: 1. hiv positive (acutely infected, viremic and elite controllers) 2. signed informed consent form 3. age at least 18 years old 4. immune controllers, two types: "elite suppressors" (hiv-positive with any three consecutive plasma hiv-1 rna pcr undetectable while off treatment) or "viremic suppressors" (hiv-positive with any three consecutive hiv-1 rna pcr \<3000 while off treatment). 5. acutely infected subjects: persons identified to have a negative hiv antibody response (elisa) but positive detection of hiv-1 in the blood (rt-pcr) or individuals who have evidence of a recent (past 30 days) hiv negative result along with a current hiv positive result. exclusion criteria: 1. uncontrolled bleeding diathesis. 2. pregnant. 3. inability to provide informed consent.
revlimid® capsules general drug use-results surveillance (relapsed or refractory fl and mzl)

Conditions: Lymphoma Nonhodgkin

Summary: to ascertain the safety of revlimid® capsules 2.5 mg or 5 mg under the actual use conditions in patients who received r2 combination therapy with the drug and rituximab for the first time for relapsed or refractory follicular lymphoma (fl) or marginal zone lymphoma (mzl). in particular, this surveillance will collect only information of occurrence state and treatment methods on bone marrow depression (neutropenia), which is specified as a safety specification, as well as on tumor flare, for which attention should be called. 1. planned registration period 1.5 years 2. planned surveillance period 3 years from the start of this survey


Eligibility criteria:
inclusion criteria: - relapsed or refractory follicular lymphoma or marginal zone lymphoma exclusion criteria: * n/a

Keywords: lymphoma nonhodgkin low-grade b-cell follicular marginal zone safety revlimid rituximab actual use conditions r2 combination therapy bone marrow depression neutropenia tumor flare
a trial of hrs-6768 in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: the study is being conducted to evaluate the pharmacokinetics, radiation dosimetry, safety and preliminary efficacy of hrs-6768. to explore the reasonable dosage of hrs-6768 in the treatment of patients with advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent 2. subjects with solid tumors who have been histologically or cytologically diagnosed with advanced - stage (unresectable or metastatic) disease, have failed standard treatment (disease progression or intolerance), or lack effective treatment methods. 3. there must be at least one measurable lesion as the target lesion (according to the recist v1.1 criteria). 4. ecog 0-1 5. the functions of major organs are in good condition. exclusion criteria: 1. the patient has experienced significant weight loss within 28 days prior to signing the informed consent form. 2. the patient has previously received radiopharmaceutical therapy or radioactive embolization, or has previously undergone any external beam radiotherapy (ebrt) involving more than 25% of the bone marrow, or has previously had ebrt directly applied to the kidneys, or has received any ebrt within 2 weeks before the first dose. 3. the patient has received anti - tumor treatments such as surgery (excluding diagnostic biopsy and serous cavity effusion drainage), checkpoint inhibitor therapy, other antibody therapies, chemotherapy, targeted therapy, gene therapy, and vaccine therapy within 4 weeks before the first dose. 4. the patient has had a severe infection (ctcae \> grade 2) within 4 weeks before the first dose, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications. the patient has had symptoms and signs of infection within 2 weeks before the first dose that require intravenous antibiotic treatment (excluding cases of prophylactic antibiotic use).
registry of sarcoma patients treated with permanently implantable ldr civasheet®

Conditions: Sarcoma

Summary: this patient study will determine the safety and toxicity of a permanently implantable brachytherapy source - civasheet® - which is designed to deliver a therapeutic dose of low dose rate (ldr) radiation with polymer encased palladium-103. civasheet will be implanted in sarcoma patients with disease presenting in the retroperitoneum, abdomen, pelvis and trunk.

civasheet® is an fda-cleared product from civatech oncology®. it is a series of small radioactive palladium-103 (pd-103) sources on bio-absorbable, flexible, bio-compatible membrane. the civasheet can be custom cut in the operating room. the civasheet is 5 cm wide by 15 cm long and has a rim to allow an easy surface to suture. this flexible device can contour the surgical cavity delivering highly conformal and targeted radiation dose. civasheet can deliver a very high radiation dose to the surgical margin to potential prevent local cancer recurrence. sarcoma patients have up to 80% local recurrence rates, depending on histology and location of disease presentation. civasheet will be implanted at the surgical margin follow tumor removal. monitoring the rate of acute toxicity is the primary endpoint. secondary endpoints include disease progression and recurrence rates.

Eligibility criteria:
inclusion criteria: 1. subject signed inform consent 2. subject plans to remain in the long-term care of his/her enrolling center/investigators. 3. sarcoma evident on imaging. pathology biopsy proven or suspected by imaging but not a biopsy candidate. 4. sarcoma in the retroperitoneum, abdomen, pelvis, or trunk 5. subject is able to undergo surgery exclusion criteria: 1. is unable or unwilling to comply with protocol requirements. 2. is enrolled in another study/registry not approved by civatech oncology. 3. pregnancy, breast feeding

Keywords: civasheet iort intraoperative radiation therapy brachytherapy
prospective cohort of immune checkpoint inhibitor-induced hepatitis

Conditions: Liver Injury; Secondary to Immune Checkpoint Inhibitors; Cancer Patients

Summary: background and study rationale immune checkpoint inhibitors (ici) are a breakthrough cancer treatment that boosts the immune system to fight tumors. while effective, they can cause immune-related side effects, including liver inflammation (ici-induced hepatitis or chili), which affects up to 25% of patients. severe cases requiring treatment discontinuation are rare but challenging to manage. study objective this multicenter prospective study aims to better understand chili, its clinical patterns, treatment response, and risk of recurrence. it will focus on different types of liver injury (cholestatic, hepatocellular, or mixed) to guide better treatment decisions. innovation and approach currently, there is no clear consensus on how to manage chili or when to safely restart immunotherapy. this study will collect real-world data from adult patients treated with icis, following international guidelines or a pragmatic approach when no consensus exists. findings will help improve care strategies for patients experiencing ici-related liver toxicity.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patient willing to participate in the study * patient with cancer receiving neoadjuvant, adjuvant, or maintenance treatment · patient treated with ici, either as monotherapy or in combination with another antitumor treatment (targeted therapy, chemotherapy, or radiotherapy), either de novo or after a first-line treatment including icis * patient who has received at least one injection of an ici · * onset of hepatitis following treatment initiation, defined by the following criteria: * alt (alanine aminotransferase) ≥ 5 times the upper normal limit * alp (alkaline phosphatase) ≥ 2 times the upper normal limit * alt (alanine aminotransferase) ≥ 3 times the upper normal limit and bilirubin ≥ 2 times the upper normal limit · * patient with grade 3 or 4 hepatitis, according to the current ctcae classification * exclusion criteria: * patient with another cause of acute hepatitis, including viral, autoimmune, ischemic, acute alcoholic hepatitis, or wilson's disease. * patient unable to express their non-opposition to participate in the study. * person deprived of liberty, under guardianship or curatorship, or in an emergency situation. * person not affiliated with a social security system or without entitlement to healthcare coverage.

Keywords: immune checkpoint inhibitors immunotherapy drug-induced liver injury hepatitis cholangitis ursodeoxycholic acid
effects of melatonin and oxygen consumption and choroidal blood flow

Conditions: Vasospastic Syndrome

Summary: does melatonin affect basal metabolic rate, increase choroidal blood flow and reduce the vasospastic syndrome (vs)? the main questions are: do women with vs exhibit... * a different basal metabolic rate * a reduced choroidal blood flow * a reduced increase of oxygen consumption after intake of ice-water * a different oxygen consumption after melatonin intake * a different choroidal blood flow after melatonin intake * a different oxygen consumption after melatonin intake and after intake of ice-water....?

study description: melatonin, a natural hormone of the pineal gland exclusively released during the dark phase, exhibits vasodilatatory effects in distal skin regions and reduces core body temperature. this study investigates whether exogenous melatonin (5mg p.o. at 2p.m.) in the afternoon, when no endogenous melatonin is secreted, increases not only distal skin blood flow, but also choroidal blood flow and changes oxygen consumption. two subject groups were studied, women with vasospastic syndrome (vs) and controls. the main hypothesis is: melatonin normalizes distal vasoconstriction in vs. further questions will also be answered: does melatonin affect basal metabolic rate, increase choroidal blood flow and reduce the vasospastic syndrome (vs)? do women with vs exhibit: * a different basal metabolic rate * a reduced choroidal blood flow * a reduced increase of oxygen consumption after intake of ice-water * a different oxygen consumption after melatonin intake * a different choroidal blood flow after melatonin intake * a different oxygen consumption after melatonin intake and after intake of ice-water....?

Eligibility criteria:
inclusion criteria: * vasospastic syndrome * healthy exclusion criteria: * sick * bmi \>25 or \<18 * migraine * drug intake

Keywords: melatonin skin blood flow choroidal blood flow vasospastic subjects normal subjects
development and testing of adolescent twelve-step facilitation

Conditions: Alcohol Abuse; Alcohol Dependence; Drug Abuse; Drug Dependence

Summary: this study is the first to develop and test in a randomized experimental design the efficacy of an integrated 12-step facilitation intervention tailored for young people. in the first phase of the study, the investigators are developing and revising a preliminary manual for the two sessions individually-delivered motivational enhancement therapy (met) component and subsequent 8 session group-delivered cognitive-behavioral therapy (cbt) component which will integrate twelve-step facilitation (tsf). forty adolescents each will complete the preliminary integrated tsf protocol. in the second phase of the study, the investigators will compare integrated tsf (itsf) to standard treatment (met/cbt) in a randomized experimental design for adolescent substance use disorder with 60 adolescents. as a result, the investigators will examine potential mechanisms that may underlie the efficacy of itsf in improving alcohol and other drug use outcomes. the investigators will test group differences on potential mechanisms of change (e.g., alcoholics anonymous/narcotics anonymous attendance and involvement) and whether these variables are associated with substance use outcomes.


Eligibility criteria:
inclusion criteria: * young people between the ages of 14 and 21 that meet criteria for alcohol or other drug abuse or dependence. exclusion criteria: youth * with an active psychotic disorders * who are in another substance use disorder (sud) treatment program or receiving sud related psychotherapy that could conflict with our treatment * with a history of severe or complicated withdrawal (e.g., alcohol seizure history) * who may be using alcohol/drugs prior to study entry at levels likely to result in severe withdrawal complications, in the absence of any history * taking addiction treatment medications (e.g., buprenorphine) * who cannot speak english because the treatment and assessment instruments will be conducted in english

Keywords: adolescents alcohol abuse alcohol dependence drug abuse drug dependence substance use disorder alcoholics anonymous motivational enhancement therapy cognitive behavioral therapy
digital breast tomosynthesis in younger symptomatic women

Conditions: Breast Cancer

Summary: this study will examine a new imaging technique called digital breast tomosynthesis (dbt) compared to standard mammography in women under 60 presenting with signs of breast cancer. the reason that we need to do this study is that standard mammography fails to detect the cancer in approximately 20% of these women because younger women have denser breast tissue. we hope that dbt will be more sensitive in detecting breast cancer than standard mammography.


Eligibility criteria:
inclusion criteria: * female * under 60 years old * clinical or ultrasound suspicion of breast cancer exclusion criteria: * unable to give informed consent * male * obvious advanced breast cancer * obvious medical problems meaning surgery would not be an option

Keywords: breast cancer digital mammography tomosynthesis
postoperative bracing patterns after lumbar surgery

Conditions: Lumbar Spine Degeneration; Arthrosis; Spine; Surgery

Summary: a variety of postoperative bracing are routinely applied after spinal procedures but there are limited data regarding their efficacy, especially with the increasing use of internal fixation.currently, no data are available regarding the use of postoperative braces in belgium. bracing is sometimes considered after lumbar surgery for degenerative conditions. all neurosurgeons and orthopedical surgeons in belgium will be questioned to assess the patterns of postoperative bracing use after lumbar surgery.

subjects: all neurosurgeons and orthopedical surgeons in belgium outcomes: the content of the questionnaire is based on a previously conducted study in the usa, cfr. "bible, j. e., biswas, d., whang, p. g., simpson, a. k., rechtine, g. r., grauer, j. n. (2009). postoperative bracing after spine surgery for degenerative conditions: a questionnaire study. the spine journal, 9(4), p. 309-316." permission to use this questionnaire was received from the corresponding author. more specifically, a single-page questionnaire will be distributed to all spinal surgeons affiliated to the spine society belgium. the questionnaire will focus on whether surgeons typically immobilize patients after specific spinal procedures, the type of orthosis used, the duration of treatment, and the rationale for bracing. data analysis: both descriptive and inferential statistical methods will be used. the study frequencies and percentages for categorical variables will be calculated. chi-square analysis will be used. significance level will be set at 0.05.

Eligibility criteria:
inclusion criteria: * orthopaedic surgeon or neurosurgeon in belgium exclusion criteria: * n/a
precision sleep medicine

Conditions: Obstructive Sleep Apnea

Summary: this retrospective observational study aims to characterize the prevalence and clinical features of obstructive sleep apnea (osa) phenotypes and develop a rater-independent algorithm for automated osa phenotyping, improving diagnosis and personalized treatment.

obstructive sleep apnea (osa) is characterized by repeated upper airway blockages during sleep, but it presents with a range of phenotypic variations, each with potentially distinct clinical implications. current clinical definitions are not always precise, making it difficult to clearly classify patients with overlapping features. this phenotypic overlap poses challenges for understanding the true prevalence of "pure" versus "mixed" osa phenotypes and their respective clinical implications. to comprehensively characterize the prevalence and clinical features of distinct osa phenotypes in a large, diverse patient population, this retrospective study analyzes polysomnography (psg) data from two publicly available national sleep research resource datasets. the findings are then compared to datasets from the university hospital basel and university children's hospital basel to assess generalizability. furthermore, the study employs computer-aided analysis of psg data to develop rater-independent algorithms for objective and automated osa phenotyping. these advancements aim to improve understanding of osa heterogeneity, facilitating more precise diagnoses and personalized treatment strategies.

Eligibility criteria:
inclusion criteria: * age 19 years and older (data from university hospital basel (usb)) * age 18 years or younger (data from university children's hospital basel (ukbb)) * epworth sleepiness scale (ess) score available (usb only) * diagnosis available (e.g. obstructive sleep apnea (osa), central sleep apnea (csa), cheyne stokes breathing (csr), ...) * signed written general consent exclusion criteria: * history of treatment of sleep apnea * tracheostomy * current home oxygen therapy * decline to sign the written general consent, or absence of written general consent

Keywords: polysomnography (psg) recordings
comparison between efficacy of topical sildenafil 2% and topical minoxidil 5% in treatment of androgenic alopecia

Conditions: Androgenic Alopecia

Summary: androgenetic alopecia (aga) is hair loss with specific clinical pattern, it is characterized by follicular miniaturization, which occurs due to systemic androgens and genetic factors. prevalence differs according to ethnic groups. it is more common and more severe in white men than in asian and black men. the incidence increases with age. according to hamilton's study, the prevalence is 30% in men at the age of 30, and 50% in the age of 50. generally, the age of onset is the 3rd and 4th decade.

androgenetic alopecia may affect self-esteem and quality of life in several affected individuals. there are two fda-approved drugs for pattern baldness: topical minoxidil and finasteride, both of which require at least a 4- to 6-month trial before noticing improvement and must be used indefinitely to maintain a response. as such, medication adherence often can be poor. furthermore, initiation of the drug may cause an initial shedding phase. minoxidil was the first and, so far, the only topical product that has been fda approved for the treatment of aga. minoxidil was originally developed as an oral medication for hypertension. hypertrichosis was found in 24-100 % of patients treated with oral minoxidil, which led to the treatment of aga with topical minoxidil. androgenic alopecia is caused by the overproduction of 5αdihydrotestosterone (5α-dht), a potent androgen within the hair follicle, specifically the dermal papilla (dp) cells that are the main regulators of hair growth and are the only site of 5α-dht action. sildenafil is a selective inhibitor of phosphodiesterase 5 and was originally developed as an anti-anginal drug due to its vasodilatory and antiplatelet coagulation properties. sildenafil enhances the proliferation of human dermal papilla cells and up-regulates the mrna expression of vascular endothelial growth factor and platelet-derived growth factor (pdgf) which are responsible for hair growth. topical sildenafil 1% has been used in the treatment of male androgenic alopecia.

Eligibility criteria:
inclusion criteria: * subjects clinically and dermoscopic diagnosed with aga. * age ranges from 18 to 45 years old. * males * willingness to provide pictures and follow-up studies. exclusion criteria: * patients who received any topical or systemic treatment for aga during the last 6 months, * patients who had other types of alopecia such as alopecia areata, alopecia totalis, telogen effluvium, anagen effluvium, and acquired cicatricial alopecia. * patients with anemia, thyroid disease, and vitamin d deficiency, * any autoimmune disease or chronic debilitating disease (chronic renal failure, congestive heart failure, hepatic patients, cancer patients).