Kornimate/medical-research-clean huggingface dataset:
motor development and orthoses in spinal muscular atrophy (sma)

Conditions: Spinal Muscular Atrophy

Summary: spinal muscular atrophy (sma) is neurodegenerative disease of anterior horn cells of spinal cord and represents the second more frequent pathology in childhood. according to the age of onset and the maximum motor function the disorder is classified in 4 types. patients with sma ii and sma iii often use orthoses to achieve postural and dynamic functions. in this retrospective observational study the investigators describe the characteristics of sitting position, standing and walking correlated to type and time of orthoses used.

we collect data from patients with sma ii and sma iii referred to udgee from jan. 1995 to dec. 2008. we estimate to achieve informations about 50-70 patients.

Eligibility criteria:
inclusion criteria: * clinical and genetics diagnosis of sma ii and sma iii exclusion criteria: * n/a

Keywords: spinal muscular atrophy motor development orthoses
effect of sarpogrelate on platelet aggregation in patients with cerebral infarction: dose-responsive clinical pharmacology study

Conditions: Cerebral Infarction

Summary: sarpogrelate is an antiplatelet agent that decreases 5-hydroxytryptamine( 5-ht )levels in platelets via blockade of 5-ht2 receptors, has been used in atherosclerotic peripheral arterial disease. the present double-blind controlled clinical pharmacology study was performed on 45 patients with cerebral infarction, who were given 75, 150, or 300 mg three times daily of sarpogrelate for 7 days in order to evaluate the dose-response relationship in terms of the precisely measured inhibition of platelet aggregation.


Eligibility criteria:
inclusion criteria: 1. cerebral infarction except cardiac source of embolism based on the nindsⅲclassification 2. neurological signs persisting≧ 1 day from onset 3. defined onset of symptoms, and stable condition at the period of enrollment 4. ct or mri detection of responsible site 5. age≧20 6. systolic pressure≦180 mmhg, diastolic pressure≦110 mmhg 7. the maximum intensity of platelet aggregation is above 15 % induced by serotonin (1µm) and epinephrine (3µm) on the day of prior to the first medication 8. written informed consent must be obtained from the patients before enrollment into the study exclusion criteria: 1. functional outcome at randomization: modified rankin scale=4, 5 2. previous or planned for vascular surgery to cerebral infarction 3. history of intracranial hemorrhage 4. history of systemic bleeding, or other history of bleeding diathesis or coagulopathy 5. with severe complications ( renal or hepatic insufficiency, heart failure, hemopathy, and so on ) 6. treating malignant tumor 7. pregnant or possibly pregnant women, or nursing mothers 8. history of sarpogrelate sensitivity 9. previously entered in other clinical trials within 3 months 10. less than 3 months since any other clinical trial 11. judged by investigator to be unsuitable for the study
a study of ly2140023 in schizophrenia patients with prominent negative symptoms

Conditions: Schizophrenia

Summary: the purpose of this study is to determine whether ly2140023, when added to standard-of-care antipsychotic treatment, will improve negative symptoms.

the primary objective of this study was to test the hypothesis that treatment with ly2140023 compared to placebo, when added to a fixed dose of a standard of care (soc) antipsychotic, would demonstrate significantly greater reduction of negative symptoms, as assessed by the 16-item negative symptom assessment scale (nsa-16), in patients with schizophrenia. patients included in this study were concurrently receiving 1 of 4 second generation antipsychotics (sgas): aripiprazole, olanzapine, risperidone, or quetiapine.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of schizophrenia * participants must have been receiving monotherapy treatment for at least 3 months prior to study entry with one of 4 atypical antipsychotic medications (aripiprazole, olanzapine, risperidone, quetiapine) * disease symptoms must meet a certain range as assessed by the clinician * participants must have evidence of prominent negative symptoms of schizophrenia (for example blunted affect, emotional withdrawal, or motor retardation) * participants must be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures * participants must be able to understand the nature of the study and have given their informed consent exclusion criteria: * participants who are actively suicidal * participants who are pregnant or nursing * participants who have had electroconvulsive therapy (ect) within 3 months of screening or who will have ect at any time during the study * participants with uncorrected narrow-angle glaucoma, history of or current seizure disorder, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, uncontrolled thyroid condition or other serious or unstable illnesses * participants with parkinson's disease, psychosis related to dementia or related disorders * participants with known human immunodeficiency virus positive (hiv+) status
telemedicine in the management of pain in patients with advanced or metastatic pancreatic cancer

Conditions: Adenocarcinoma; Pancreatic Cancer Metastatic; Pain

Summary: adenocarcinoma of the pancreas is a major public health issue because of its disastrous prognosis. the symptomatology of locally advanced or metastatic forms, particularly painful, is often major and difficult to balance, impacting both the quality of life of patients (and those around them) and the course of treatment (chemotherapy). the objective of this study is to evaluate the interest and feasibility of telemedicine in the management of pain in patients undergoing treatment for advanced or metastatic pancreatic cancer.


Eligibility criteria:
inclusion criteria: * patient ≥ 18 years old ; * patient with histologically or cytologically proven locally advanced and/or metastatic adenocarcinoma of the pancreas; * patient undergoing or failing medical treatment and comfort care only; * patient with eva ≥ 4 and/or requiring analgesics level 3; * performans status (ecog) \< 3 ; * informing the patient and obtaining free, informed and written consent signed by the patient and the investigator; * patient affiliated or beneficiary of the social security system exclusion criteria: * patient does not have a smartphone, tablet or computer; * patient with no personal internet access at home (wifi, wired), or via his smartphone; * patient does not feel able to fill out an electronic questionnaire; * patient cannot read or write french; * patient does not speak and understand french; * persons deprived of liberty or under guardianship or trusteeship ; * dementia, mental alteration or psychiatric pathology that could compromise the patient's informed consent and/or compliance with the protocol and follow-up of the trial ; * inability to submit to trial protocol follow-up for geographical, social, or other reasons ; * patient participating in another interventional study evaluating treatment and pain management.

Keywords: telemedicine
study to check the efficacy and safety of recombinant bcg vaccine in prevention of tb recurrence

Conditions: Prevention of TB Recurrence

Summary: this is a phase ii/iii trial with two groups of adults successfully cured of category 1 pulmonary tb receiving either vpm1002 or placebo. single dose of vpm1002 / placebo will be administered to calculate efficacy of the vaccine against tb recurrence.

the study is designed as a multicenter, double-blinded, randomized, placebo-controlled trial with two groups of category 1 pulmonary tb patients who have successfully completed att and declared cured by bacteriological confirmation. the eligible participants will be randomized in 1:1 ratio to receive single dose of either vpm1002 or placebo. after study vaccination, participants will be followed up for one year. any suspected tb case during follow up will be further evaluated and bacteriologically confirmed. study participants will be actively followed up for 2 months post-vaccination for any solicited local and regional reaction. saes will be recorded and reported throughout study participation.

Eligibility criteria:
inclusion criteria: 1. males or females aged ≥18 and ≤65 years. 2. bacteriologically confirmed category i pulmonary tb patients (including controlled diabetics with hba1c level ≤7% and non-diabetics) who successfully completed att as per national guidelines. 3. must have a sputum sample showing bacteriologic confirmation of cure - defined as smear negative. 4. female participants who are currently using reliable methods of birth control, have a negative pregnancy test during screening and have no intention to become pregnant for at least 3 months post-vaccination. 5. participant must intend to remain in the area during the study period. exclusion criteria: 1. reactive serology for hiv 2. history of extrapulmonary tb 3. known or suspected impairment of immunological function 4. pregnant and / or lactating female participants

Keywords: recombinant bcg vaccine category 1 pulmonary tuberculosis recurrence efficacy
composition for treating cirrhosis and liver cancer (sb-1121)

Conditions: Cirrhosis of the Liver

Summary: the composition treats cirrhosis and hepatocellular carcinoma (hcc) at an early stage. the product is extracted from herbs, including adenosma glutinosum extract, eclipta prostrata extract, phyllanthus urinaria extract, impatiens balsamina extract, ascorbic acid, pyridoxine 5-phosphate, l-arginine hydrochloride, pregnenolone acetate. these components have participated in repairing and regenerating new liver parenchyma, preventing fibrosis cell generation, preventing liver cancer cell growth at an early stage. the composition supplements precursors which help the body strengthen antibodies and reduce the risk of inflammation, restore physiological and biochemical functions of liver cells after chronic inflammation.

the composition is fractionally extracted from herbs. flavonoids, isoflavonoids, and pregnenolone combined with ascorbic acid, pyridoxine 5-phosphate, l-arginine act as the key compounds in the regeneration of fibrosis liver cells, remove scar tissue, stimulate and release growth hormones, prevent progression to hcc and prevent hcc recurrence. the pharmaceutical ingredients involved in the composition are calculated to increase their effectiveness in preventing and curing cirrhosis and hcc. currently, many preparations have been and are being studied to fight against cirrhosis and liver cancer globally. the effectiveness of this preparation is a new finding which has been proven over 5 years of follow-up. pregnenolone is a cortisol precursor. cortisol plays an important role in several systems in the body, including the immune system(in the cycle of the immune system to produce b lymphocytes). this ingredient is used as a supplement to stabilize the endothelium, regulate the amount of cortisol within normal limits, and help the body produce b lymphocytes with a good response. kaempferol is a flavonoid that participates in cell protection against toxic proteins which were produced during prolonged inflammation; blocking the action and removing denatured proteins that change the parenchyma of liver cells. the selected flavonoids repaired the fibrotic structure of liver parenchyma after chronic inflammation. ascorbic acid, pyridoxine 5-phosphate, and l-arginine help to facilitate biological functions in cell adhesion, synergize with flavonoids in cell membrane protection, structural repair, and liver cell regeneration. ascorbic acid, pyridoxine 5-phosphate act as enzymes that catalyze processes conveniently.

Eligibility criteria:
inclusion criteria: * all patients with underlying medical conditions who have been taking medications for these conditions. * patients with aids, hiv, hbv, hcv, and patients with co-infections. * the cancer patients are stable. * patients with congenital or acquired immunodeficiency. exclusion criteria: * unstable cancer patients. * decompensated cirrhosis.

Keywords: liver cirrhosis hcc flavonoids pregnenolone ascorbic acid b6
ngs for spine surgery patients

Conditions: Spine Infection

Summary: during revision spinal surgery for aseptic indications, there remains a concern that the failure may have resulted from undetectable subclinical infection. in the common revision indications of hardware loosening and adjacent segment disease it is possible that bacterial colonization and low-grade infection precipitated the failure event. there is also significant controversy on the role infectious processes have in the development of degenerative disc disease (modic changes). in particular, this study will investigate whether discogenic colonization with propionibacterium acnes (p. acnes) can be associated with modic changes. whereas, in surgery for known spinal infection, epidural abscess and septic revisions, it is possible that standard culture techniques fail to detect polymicrobial flora or accurate speciation. this may lead to inappropriate antibiotic management that is not addressing the range of pathology present. there remains an incomplete understanding of the role that subclinical infection plays in aseptic spinal revision surgery and degenerative disc disease


Eligibility criteria:
inclusion criteria: * all patients \>18 years of age undergoing spinal surgery exclusion criteria: * all patients \<18 years of age undergoing spinal surgery
a study assessing the efficacy of combined use of clascoterone 1% cream and adapalene 0.3% for the treatment of acne

Conditions: Acne Vulgaris

Summary: winlevi is the first topical anti androgen and sebum inhibitor approved for acne vulgaris. there is no study assessing winlevi in combination treatment for acne .therefore this study assesses winlevi with adapalene 0.3% gel in combination to emulate real life practice.


Eligibility criteria:
inclusion criteria: i. outpatient, male or female subjects of any race, and at least 12 years of age or older. * female subjects of childbearing potential must have a negative urine pregnancy test result at baseline (test must have a sensitivity of at least 25miu/ml for human chorionic gonadotropin) and practice a reliable method of contraception throughout the study: * a female is considered of childbearing potential unless she is: 1. postmenopausal for at least 12 months prior to study drug administration; 2. without a uterus and/or both ovaries; or 3. has been surgically sterile for at least 6 months prior to study drug administration. * reliable methods of contraception are: 1. hormonal methods or intrauterine device in use \> 90 days prior to study drug administration; 2. barrier methods plus spermicide in use at least 14 days prior to study drug administration; or 3. vasectomized partner (vasectomy must be performed 3 months prior to first study drug administration or in the alternative a zero sperm count will suffice). * exception: female subjects of childbearing potential who are not sexually active will not be required to practice a reliable method of contraception. these subjects may be enrolled at the investigator's discretion if they are counseled to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study. ii. facial acne iga score of 3 or 4. iii. able to understand the requirements of the study and sign informed consent/hipaa authorization forms. subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian. exclusion criteria: i. female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control. ii. allergy or sensitivity to any component of the test medications (section 5.2). iii. subjects who have not complied with the proper wash-out periods for prohibited medications (supplement i). iv. medical condition that, in the opinion of the investigator, contraindicates the subject's participation in the clinical study. v. skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris vi. evidence of recent alcohol or drug abuse. vii. history of poor cooperation, non-compliance with medical treatment, or unreliability. viii. exposure to an investigational drug study within 30 days of the baseline visit.
evaluation of the social abcs in israel

Conditions: Autism; Autism Spectrum Disorder (ASD)

Summary: the goal of this study is to evaluate the effectiveness of the social abcs program for young autistic children and their parents. the study will also explore predictors of treatment success and child outcomes. the main questions it aims to answer are: * does the social abcs program help children use more words and communicate better? * does the program help parents feel more confident and less stressed? * which children and parents benefit most from the program? participants will: * join a 6-week social abcs program with weekly group and individual coaching sessions * complete assessments before and after the program to see how their child and family are doing * take part in short video-recorded play sessions to see how communication changes over time


Eligibility criteria:
inclusion criteria: * children who met diagnostic criteria for autism according to the diagnostic and statistical manual of mental disorders (dsm-v), established by independent gold-standard assessments by both a psychologist and a physician (i.e., child psychiatrist, developmental pediatrician, or child neurologist) * diagnosis received before 30 months of age. * full-term birth (36-42 weeks gestation) with birth weight \>2500 grams exclusion criteria: * identifiable neurological, genetic, or severe sensory/motor conditions * attending a special education kindergarten * participating in a concurrent parent-mediated intervention.

Keywords: social abcs parent-mediated intervention naturalistic developmental behavioral intervention pivotal response treatment early intervention group intervention social communication
control of blood glucose fluctuation with usage of polyherbal

Conditions: Diabetes Mellitus

Summary: the aim of the study is to get insight into control of glycemic variability with sugar balance capsules which is the leaves of three herbs: ivy ground (coccinia indica)-200mg, bougainvillia (bougainvillea spectabilis)-30mg, madagascar periwinkle (catharanthus rosea)-20mg.

the glycemic variability would be obtained at 14 days with the usage of flash glucose monitoring system manufactured by abbott and outcomes would be compared at the end of ambulatory glucose profile.

Eligibility criteria:
inclusion criteria: adult males and non-pregnant females aged ≥18 years having a diagnosis of pre-diabetes (impaired fasting glucose or impaired glucose tolerance) or diabetes and meeting one of the following criteria 1. fasting plasma glucose ≥100 mg/dl, fasting defined as no caloric intake for at least 8 hours, and 2. glycosylated haemoglobin (a1c) ≥ 6 %. the test should be performed in a laboratory using a method that is national accreditation board for testing and calibration laboratories certified and standardized within last 3 months. exclusion criteria: any one of the following 1. patients on insulin therapy. 2. any history suggestive of micro vascular or macro vascular disease - coronary artery disease, stroke, peripheral artery disease or diabetes related retinal changes. 3. women in child bearing age unable to practice any form of contraception 4. patients with diagnosis of anemia (hb\<11 g/dl in female and \<13 g/dl in male) 5. impaired renal function; estimated estimated glomerular filtration rate \<60mls/min/1.73m2. 6. known history of any chronic illness taking regular pharmacological agents. 7. blood pressure fluctuations exceeding 20 mm of hg on 2 subsequent clinic visits or known history of hypo tension or bradycardia in last 6 months or taking 3 or more anti-hypertensive medications regularly in the last 6 weeks 8. known history of autonomic dysfunction like diabetic autonomic neural imbalance or neuropathy 9. current or former employees of organic india or any potential conflict of interest in participation 10. participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days. 11. refusing consent or physician uncomfortable with patient compliance to treatments or follow up.
laboratory and ultrasound findings and response to letrozole in pcos patients

Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Summary: the goal of this observational study is to compare laboratory and ultrasound findings between letrozole-resistant and letrozole-sensitive pcos patients in egypt. the study will include women aged 18-40 years diagnosed with pcos based on the rotterdam criteria, who are undergoing ovulation induction with letrozole for the first time. the main questions it aims to answer are: what are the baseline laboratory and ultrasound differences between letrozole-resistant and letrozole-sensitive pcos patients? what factors can predict letrozole resistance in pcos patients? researchers will compare letrozole-resistant and letrozole-sensitive pcos patients to determine whether specific laboratory markers and ultrasound findings can predict resistance to letrozole. participants will: undergo baseline clinical, laboratory, and ultrasound assessments before starting letrozole treatment. receive letrozole treatment with dose escalation up to 7.5 mg/day over a maximum of three cycles if ovulation is not achieved. be monitored through serial transvaginal ultrasounds to assess follicular development. have ovulation confirmed via mid-luteal serum progesterone levels. the study aims to improve the understanding of predictors of letrozole resistance to guide personalized ovulation induction strategies in pcos patients.


Eligibility criteria:
inclusion criteria: * women aged 18-40 years. * diagnosis of pcos based on rotterdam criteria. * no prior ovulation induction with letrozole. * willing to follow the treatment protocol and attend follow-up visits exclusion criteria: * infertility due to other causes such as tubal obstruction or male factor infertility. * previous ovarian surgery or use of medications that could influence ovulation. * comorbidities such as uncontrolled diabetes, hyperprolactinemia, or thyroid dysfunction.

Keywords: pcos letrozole
antibiotic prophylaxis in mesh repair of inguinal hernias

Conditions: Inguinal Hernia

Summary: inguinal hernia repairs is clean surgical procedures. however infection may be a concern when prosthetic materials are used. this prospective randomized study has been set to observe if antibiotic prohylaxis is of benefit in mesh repair of inguinal hernias.

there are two group in the study. control group received no antibiotic prohylaxis, whereas a single dose 1 gr. intravenous cefazoline is given to the patient in prophylaxis arm of the study. 30-days surgical site infection rates and 1 year prosthetic intervention late infection rates are observed and recorded. side effects of antibiotic used are also recorded.

Eligibility criteria:
inclusion criteria: inguinal hernia repair - exclusion criteria: uncontrolled diabetes mellitus, -

Keywords: inguinal hernia, antibiotic, prophylaxis