Kornimate/medical-research-clean huggingface dataset:
clinical study on modified allogeneic hematopoietic stem cell transplantation regimen for severe aplastic anemia

Conditions: Severe Aplastic Anemia

Summary: the aim of this study was to evaluate the safety and efficacy of a modified allogeneic hematopoietic stem cell transplantation regimen for aplastic anemia.

objectiveto evaluate the safety and efficacy of a modified allogeneic hematopoietic stem cell transplantation regimen in aplastic anemia. aplastic anemia (aa) is a group of myelo-hemopoietic failure syndromes caused by a variety of etiologies. if not intervened, the average expected survival time is less than half a year.allogeneic hematopoietic stem cell transplantation (allo-hsct) is one of the possible cures for this disease. the success rate of treatment for this disease can be further improved under the previous regimen system. the survival rate reported in the literature is 60%-90%. we designed this study to improve the conditioning regimen and optimize the ghvd prevention measures to improve the transplant success rate and prolong patient survival, while minimizing the occurrence of gvhd and reducing the recurrence rate of the disease.30 patients with aplastic anemia were planned to be enrolled.

Eligibility criteria:
inclusion criteria: 1. patients with benign or malignant hematological diseases such as leukemia, lymphoma, thalassemia, aplastic anemia, etc. diagnosed by nccn guidelines, and requiring allogeneic hematopoietic stem cell transplantation as determined by the researchers; 2. age 3-65 years old; 3. weight 10kg-100kg; 4. eastern cooperative oncology group (ecog) score ≤3; 5. no major organ injury (ecg ejection fraction \>45%; bilirubin \< 2 times the upper limit of normal value; ast and alt \< 3 times the upper limit of normal value; serum creatinine \< 2 times the upper limit of normal value); 6. no severe infection; 7. subjects voluntarily participated in this clinical trial and signed the informed consent. exclusion criteria: 1. patients with nonhematologic diseases who are not eligible for transplantation or who do not wish to receive transplantation; 2. patients with an expected survival of less than 1 month; 3. patients with previous autologous or allogeneic hematopoietic stem cell transplantation; 4. pregnant patients; 5. patients with severe mental or neurological disorders that would affect the ability to provide informed consent and/or to report or observe adverse events; 6. other conditions that the investigator determines to be inappropriate for enrollment.

Keywords: severe aplastic anemia modified transplantation system ruxolitinib melphalan
efficacy of eye movement desensitization and reprocessing (emdr) in dental phobia

Conditions: Dental Phobia

Summary: the purpose of this study is to find out whether eye movement desensitization and reprocessing (emdr) is effective in the treatment of patients with dental phobia.

dental phobia represents a clinical condition that affects 5-15% of the community and is characterized by severe anxiety of dental treatment which leads to avoidance of treatment and, as a consequence, severe dental as well as psychosocial problems. eye movement desensitization and reprocessing (emdr) has been developed for the treatment of patients with post traumatic stress disorder (ptsd). its efficacy in ptsd patients has often been demonstrated in randomized controlled trials. recently it has been demonstrated that dental phobia is often induced by traumatic events during dental treatment and goes along with symptoms of ptsd in numerous patients. a pilot study (de jongh et al. 2002) gave hints on the efficacy of emdr in four dental phobia patients with a history of traumatization during dental treatment. this randomized wait-list control study aims to evaluate the efficacy of emdr in a larger sample of dental phobia patients.

Eligibility criteria:
inclusion criteria: * dental phobia according to the world health organization´s international classification of diseases, icd-10 (f40.2) exclusion criteria: * schizophrenic disorder * severe depression * severe dissociative disorder * organic brain disease * anorexia nervosa (body mass index, bmi \< 17) * suicidality * severe cardio-vascular disease * ophthalmic disease * pregnancy and lactation * psychopharmacological treatment * substance abuse

Keywords: dental phobia psychotherapy eye movement desensitization and reprocessing - emdr efficacy wait-list control
growth hormone in amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: several drugs have been proposed for als. these drugs included: topiramate, lamotrigine, creatine, vit. e, pentoxifylline, etc. although most of the trials showed a positive trend, none of them reached a statistically significant result. the only exception is the riluzole trial, that demonstrated a small but significant reduction in mortality between treated and untreated patients. aim of our study is to determine if the add-on of gh to treatment with riluzole is able to reduce neuronal loss in the motor cortex of als patients.

several drugs have been proposed for als. these drugs included: topiramate, lamotrigine, creatine, vit. e, pentoxifylline. although most of the trials showed a positive trend, none of them reached a statistically significant result. the only exception is the riluzole trial, that demonstrated a small but significant reduction in mortality between treated and untreated patients. when administered to sod-1 transgenic mice, igf-i prolongs survival, ameliorates muscular strength, and reduces weight and motor neuron loss, astrocyte gliosis, and ubiquitin positive protein inclusions. two clinical trials have been performed in als patients with s.c. administration of igf-i indicating a possible beneficial effect, and a third clinical trial is in progress. methionyl growth hormone (mgh) showed no effect on survival, disease progression and muscular strength. mgh was administered at a fixed dose and peripheral production of igf-i appeared to be normal. we propose a double-blind trial of growth hormone (gh) as add-on therapy to riluzole, with an individually regulated dose based on the peripheral response of igf-i. aim of our study is to determine if the add-on of gh to treatment with riluzole is able to reduce neuronal loss in the motor cortex of als patients. as secondary objectives, effect of gh on mortality, qol, and motor function will be assessed.

Eligibility criteria:
inclusion criteria: * definite/probable als according to el escorial criteria * aged \> 40, \< 85 years * progression from onset * disease duration ≤3 years * treatment with riluzole exclusion criteria: * rapid disease progression in the first 6 months after diagnosis * patients with tracheostomy and/or gastrostomy * disease duration \> 3 years * patient with exclusive bulbar or 2° motorneuron involvement * hepatic/renal failure * pregnant or breastfeeding * signs of active neoplasia * complicated diabetes * severe hypertension * unable to undergo mri exams

Keywords: amyotrophic lateral sclerosis als growth hormone igf-i
the effect of bezafibrate on the level of very long chain fatty acids (vlcfa) in x-linked adrenoleukodystrophy (x-ald)

Conditions: X-linked Adrenoleukodystrophy; Adrenomyeloneuropathy

Summary: x-linked adrenoleukodystrophy (x-ald) is an inherited metabolic disorder characterised by accumulation of very long chain fatty acids (vlcfa) in plasma and tissue. presumably this accumulation is responsible for tissue damage. the disease can cause severe demyelinisation of the central nervous system usually causing death in childhood or progressive ambulatory problems in adults caused by a progressive myelopathy. for the latter category of patients no curative treatment is currently available. recent investigations in human fibroblasts and mice identified bezafibrate as an agent that might reduce vlcfa in patients with x-ald. objective of the study: the trial is designed as an open-label pilot study. the main goal is to investigate if bezafibrate can reduce vlcfa in vivo in patient with x-ald. if there is indeed a biochemical effect, a large follow-up study will be initiated with clinical outcome parameters. study design: 10 men with x-ald will use bezafibrate during a period of 6 months (in combination with a low fat diet). on 6 different time points the participants will undergo a venipuncture for detecting possible side effects and to determine the biochemical outcome parameters. study population: adult men with x-linked adrenoleukodystrophy. intervention (if applicable): bezafibrate. primary study parameters/outcome of the study: the primary outcome parameters are cholesterol levels (total-, ldl, and hdl) and levels of triglycerides in plasma, vlcfa levels in plasma, leukocytes and erythrocytes and also c26:0-lyso-pc in bloodspots. secondary study parameters/outcome of the study (if applicable): secondary outcome parameters are side-effects (subjective and abnormalities in the safety lab).


Eligibility criteria:
inclusion criteria: * an age of 18 years or older * capable of giving informed consent and capable of visiting the hospital for follow-up visits * no contra-indications for the use of bezafibrate, e.g. kidney- and/or liver disease. * confirmed x-ald, amn phenotype (confirmed by vlcfa analysis or analysis of the abcd1 gene) exclusion criteria: * use of medication that lowers cholesterol and/or triglycerides (e.g. statins) * liver disease or and increase in serum ck of more than 3 times the baseline level * treatment with lorenzo's oil in the 8 weeks preceding the trial

Keywords: x-ald amn adrenomyeloneuropathy phenotype
observational studies of the application of bevacizumab in her2-negative breast cancer neoadjuvant chemotherapy

Conditions: Breast Cancer; Bevacizumab; Neoadjuvant Chemotherapy; Molecular Targeted Therapy

Summary: - the purpose of this study is to evaluate the efficacy and safety of the application of bevacizumab combined neoadjuvant chemotherapy in her2-negative breast cancer.


Eligibility criteria:
inclusion criteria: * her2-negative breast cancer patients * without surgery * plans to neoadjuvant chemotherapy exclusion criteria: * her2-positive breast cancer patients * post-operative patients

Keywords: bevacizumab neoadjuvant chemotherapy her2-negative breast cancer
microbiology, antimicrobial resistance and outcomes of neonatal sepsis in china

Conditions: Antimicrobial Resistance; Neonatal Sepsis

Summary: neonatal sepsis remains one of the most important cause of mortality and morbidities in china. this study will establish a prospective registral cohort of all infants with culture-proven neonatal sepsis in chinese nicus participating in the chinese neonatal network (chnn). the microbiology, antimicrobial resistance patterns and neonatal outcomes will be described in detail for this cohort.

all infants with culture-proven sepsis in nicus of chnn will be enrolled in the study. detailed data on microbiology, resistance pattern, neonatal mortality and morbidities will be collected and described. risk factors for multi-resistant bacteria infections and for sepsis-related mortality will be identified.

Eligibility criteria:
inclusion criteria: * admitted to chnn nicus from 2022.1.1 to 2023.12.31 * diagnosed with culture-proven sepsis exclusion criteria: * none
an exercise intervention trial to reduce symptoms & improve clinical outcomes of platinum-based treatment in ovarian cancer patients

Conditions: Ovarian Carcinoma

Summary: this clinical trial studies how well an exercise intervention works in reducing symptoms and improving clinical outcomes in patients with ovarian cancer undergoing platinum-based chemotherapy. exercise may "train" the body to repair deoxyribonucleic acid (dna) damage more efficiently, which may reduce symptoms related to platinum-based chemotherapy, improve quality of life, increase survival, and decrease recurrence rates in patients with ovarian cancer.

primary objectives: i. to assess the feasibility of recruiting and enrolling newly diagnosed epithelial ovarian cancer patients who have undergone debulking surgery and will be starting platinum-based chemotherapy, to an exercise trial. ii. to evaluate adherence to the data collection and exercise trial protocol. it is necessary to determine the feasibility of collecting tablet-based questionnaire data and blood samples at multiple time points in one visit. it is also critical to determine whether the exercise intervention is feasible in this patient population. secondary objectives: i. to examine changes in dna repair function before and after a single exercise session. ii. to examine changes in dna repair function, body composition, quality of life, symptoms and patient satisfaction with care over the treatment time course. iii. to examine the effect of the exercise intervention on these measurements. iv. to follow the patients an additional 12-months for clinical outcomes defined as death, cancer recurrence, or new primary cancer. outline: patients undergo supervised 1-on-1 exercise sessions for 60 minutes on day 1.treatment repeats every 3 weeks for up to 18 weeks in the absence of disease progression or unacceptable toxicity. patients also receive a home-based exercise prescription including instructions for keeping patients' heart rate within 50-80% maximum. after completion of study, patients are followed up for 12 months.

Eligibility criteria:
inclusion criteria: * women who have been newly diagnosed with a first primary, epithelial ovarian cancer, have undergone surgical debulking and who will be treatment according to the armstrong method * women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately. * newly diagnosed, primary, epithelial ovarian cancer * have undergone surgical debulking * will be treated according to the armstrong method * read and understand english * all subjects must have the ability to understand and the willingness to sign a written informed consent exclusion criteria: * subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
endometriosis and risk of miscarriage

Conditions: Endometriosis; Miscarriage

Summary: the aim of this study is to compare the rate of miscarriage at first spontaneous pregnancy among women with endometriosis with the rate of miscarriage at first spontaneous pregnancy among women without endometriosis.

all women followed up for a surgical or sonographic diagnosis of endometriosis in 11 italian referral centres for the treatment of endometriosis completed a questionnaire regarding their previous pregnancies. the same questionnaire was completed by women, attending a routine gynecologic visit, in whom surgery or vaginal examination and pelvic ultrasonography excluded endometriosis.

Eligibility criteria:
inclusion criteria: * 30 to 50 years old women * with at least one previous spontaneous pregnancy * with surgical or clinical/sonographic diagnosis of endometriosis or * in whom surgical or clinical/sonographic evaluation ruled out endometriosis exclusion criteria: * pregnancy achieved by assisted reproductive technology * biochemical pregnancy * non corrected uterine malformation, poliabortivity, lupus like anticoagulant
a study of prexasertib (ly2606368) in participants with extensive stage disease small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the safety and efficacy of prexasertib when given to participants with extensive stage disease small cell lung cancer (ed-sclc). the study will evaluate how the body processes the drug and how the drug affects the body. the study will also evaluate the association between tumor response and the participant's perceived quality of life.


Eligibility criteria:
inclusion criteria: * have ed-sclc and have received a prior platinum-based regimen * participants in cohort 1 and in the addendum must have had an objective response to prior platinum-based therapy with subsequent progression ≥90 days after the last dose of platinum * participants in cohort 2 must have either not had an objective response to prior platinum based therapy or had progression \<90 days after the last dose of platinum * have a performance status of 0 to 1 on the eastern cooperative oncology group scale exclusion criteria: * have received more than 2 prior therapies for ed-sclc (including immunotherapy, targeted therapies, or chemotherapy) * have symptomatic central nervous system (cns) malignancy or metastasis. asymptomatic participants with treated cns metastases are eligible for this study if they are not currently receiving corticosteroids to treat cns metastases * have previously completed or withdrawn from this study or any other study investigating prexasertib or a checkpoint kinase i (chk1) inhibitor or have shown hypersensitivity to any of the components of the prexasertib formulation * have a serious cardiac condition

Keywords: sclc ly2606368 chk1
combination of 68ga-psma pet data with magnetic resonance spectroscopy data (mrs) for evaluating prostate cancer

Conditions: Prostate Cancer

Summary: prostate cancer is the second most common cancer among man and the fourth most occurring over all . characterization and management of the diagnosed prostate cancer is a challenging task due to its clinically and morphologically diversity. clinically, this cancer range from indolent growing slowly malignancy, which does not threatened the patient life, to aggressive tumor that metastasize rapidly with very bad prognosis. therapy of prostate cancer ranges from a "watch and wait" approach to hormone deprivation therapy to aggressive surgical, radiation, and cryosurgical therapies depending on the cancer characteristics. prostate cancer is diagnosed using digital rectal examination, serum prostate-specific antigen (psa) testing and transrectal ultrasonography (us)-guided biopsies . imaging technologies have been adapted as a non-invasive method to obtain a comprehensive assessment of the disease. mri is widely used and more specifically multiparameter mri (mmri) for detection, staging and tumor localization. mmri uses multiphase modes including diffusion-weighted and dynamic contrast-enhanced imaging in addition to t2-weighted imaging to identify and classify cancer type . magnetic resonance spectroscopy (mrs) is mri technique that allow detection of tissue metabolic composition which is occasionally used to characterize prostate cancer, however is not used as a standard procedure. by suppression of water and fat signal, mrs sequence can detect relationship between lower concentration prostatic metabolites such as citrate, choline, creatine, and polyamines in the cell cytosol and in the extra cellular ducts. other imaging modalities used to characterize prostate cancer include ultrasound (us), computerized tomography (ct), functional imaging like bone scanning (bs) and hybrid imaging like choline based positron emission tomography and ct (pet/ct). however all of these modalities show disappointing sensitivity .

in recent years a new modality has emerged showing promising accuracy targeting the prostate specific membrane antigen (psma) which is significantly overexpressed in prostate tumor cells. by attaching radioactive isotope 68ga to psma ligands, pet/ct molecular imaging can provide information regarding prostate cancer relapses and metastases with high contrast . several recent studies showed the potential of 68ga-psma pet in many application correlated with prostate cancer such as staging, identifying reoccurrence, guided biopsy and others . in the study, we wish to utilize the new hybrid pet/mr technology and combine 68ga-psma pet studies with mrs information in order to explore correlation between the data obtained by both modalities and investigate the implication on the disease characteristics.

Eligibility criteria:
inclusion criteria: 1.patients over the age of 18 with diagnosed prostate cancer at different stages of the disease. exclusion criteria: 1. patients younger than 18 years 2. contraindication to mri or to intravenous gadolinium injection.
clinical efficacy of ceramic vs resin block endocrown

Conditions: Tooth Diseases

Summary: compare the comfort and durability of ceramic (vita,suprinity ,vs) vs resin bloc (voco, grandio bloc,gb) endocrown by chairside cad/cam system (computer aided design / manufacture). objective:to provide information of material selection for the chair-side restoration of the teeth after root canal treatment.

pulpal and periapical diseases are the main causes of tooth loss. root canal treatment (rct) is the only effective way to treat these diseases. however, failure of rct is commonly seen without coronal restoration.endocrown is a new type of onlay with a retainer in the pulp cavity which consists of a cervical margin in the form of a butt joint and a preparation of the pulp chamber.this restoration method is not only good at the preservation of residual tooth tissue, but also suitable for severely damaged molars or premolars after dental pulp treatment.more and more endondontist tend to use this ways because they are a minimally invasive solution in such cases.endocrown is mainly made of glass-ceramics, which has the advantages of beautiful appearance, high hardness and good biocompatibility. however, ceramic materials are brittle and fracturable, and need to be sintered twice in the manufacturing process, which is relatively complex and time-consuming. composite resin block material is a new type of composite material developed in recent years. it is used for chairside cad/cam restoration,it has beautiful and natural color, and its elastic modulus is close to dentin. therefore, it is more compatible with natural teeth in performance.moreover, in the process of making, the steps of secondary sintering and glazing are omitted and shortened. but, there was no sufficient data to verify which material was more effective. the main aim of this trial is to compare the clinical efficacy of ceramic vs resin-based bloc endocrown. other objectives include looking for the prognostic and influence factors of the related effects.

Eligibility criteria:
inclusion criteria: 1. the patient is healthy and is 18-75 years old and has molar teeth and tooth root apex without evident damage and no root fracture, as determined by x-ray. 2. the patient has three or four walls of intact tooth tissue after root canal treatment 3. the patient has good oral hygiene. 4. the patient has signed an informed consent form. 5. the patient is not participating in any other clinical trial. 6. the patient has received a class a assessment according to fdi criteria for marginal adaptation after restoration. exclusion criteria: 1. obvious destruction of the apical tissue or presence of large cysts or both 2. severe periodontitis 3. oral malignant tumor(s) 4. undergoing radiotherapy 5. pregnancy 6. mental illness or systemic diseases 7. incapable of self-care 8. unsuitable for the trial as deemed by the researchers

Keywords: ceramic, resin bloc, endocrown , root canal treatment, molar