cyrilzakka/clinical-trials huggingface dataset:
A Retrospective Study of Toxicity and Outcome of High Dose Chemotherapy With Autologous Stem Cell Transplant in Patients With Non-Hodgkin Lymphoma (NHL).

Patients with aggressive Non-Hodgkin-lymphoma treated at first diagnosis with chemotherapy alone or combined chemo-radiotherapy can achieve high response rates. However, patients with relapsed lymphoma still have a poor prognosis. High dose chemotherapy (HDCT) followed by autologous stem cell transplantation (ASCT) is the treatment of choice for these patients. An ASCT allows patients to receive much higher doses of chemotherapy than usual, to improve the chances of curing the disease. The high-dose of chemotherapy destroys the cells in the patients bone marrow and then the patients own cells from either the bone marrow or peripheral blood are used to rescue the patient from intensive treatment. High-dose chemotherapy with autologous stem cell (either bone marrow or peripheral blood) transplantation is used in the treatment of Intermediate/High grade NHL with poor risk disease and in second remission at the Royal Marsden Hospital.

The purpose of the present analysis is to determine independent prognostic factors correlated with the long-term outcome of patients with NHL who received an ASCT between January 1991 and June 2005. Accrual of eligible patients currently under follow-up will be performed in clinic at the time of next appointment. All patients accrued will give informed consent to participate in the study for retrospective case note review, after discussion with a study investigator and after receiving a study information sheet. The results of the analysis will be published in a peer-reviewed medical journal. This will include patients treated at the royal Marsden Hospital only.


Eligibility Criteria:
Inclusion Criteria:

- a) Age over 18 b) Patients with Non-Hodgkin's Lymphoma who have received an autologous stem cell transplant in the past.

c) Informed written consent

Exclusion Criteria:

* a) Medical or psychiatric conditions that compromise the patient's ability to give informed consent b) HIV positive or AIDS related lymphoma
Distal Radius Fractures in Adults: A Multi-Center Study in South Kivu

The goal of this observational study is to describe the epidemiological, radiological, therapeutic, and evolutionary characteristics of distal radius fractures in adults in the Bukavu Health District, South Kivu, DRC.

. The main question it aims to answer is:

• What are the epidemiological, radiological, therapeutic, and evolutionary characteristics of distal radius fractures in adults in South Kivu, and how does intrafocal nailing influence outcomes such as consolidation time and complication rates in this population?

Participants who have already operated for distal radius fracture will be enrolled in this study.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 17 years or older at the time of injury.
* Diagnosed with a distal radius fracture via clinical and radiological assessment.
* Admitted, treated, and followed up at one of the 16 participating institutions.
* Complete medical records available, including epidemiological, clinical, radiological, therapeutic, and outcome data.

Exclusion Criteria:

* Patients under 17 years of age.

  * Incomplete or missing medical records.
  * Fractures not involving the distal radius.
  * Patients transferred to non-participating facilities without follow-up data.
Evaluation of Cryotherapy in Granuloma Pyogenicum

Surgical excision needs general anesthesia and might have complications due to anesthesia. Cryotherapy can be used in an outpatient setting and doesn't need general anesthesia.

This study will evaluate if cryotherapy works in granuloma pyogenicum with the advancement of no general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

diagnosis of granuloma pyogenicum

Exclusion Criteria:

no approvement of cryotherapy
Improving Prognostic Confidence in Neurodegenerative Diseases Causing Dementia Using Peripheral Biomarkers and Integrative Modeling

To develop a model to predict disease progression in a large cohort of patients across a variety of neurodegenerative diseases, including Mild Cognitive Impairment (MCI) and dementia due to any neurodegenerative disease, including Alzheimer's Disease (AD), Lewy Body Disease (LBD), Vascular Disease (VaD) and Frontotemporal lobar degeneration (FTLD).

The goal of this study is to create a model to predict disease progression in patients with mild cognitive impairments and forms of dementia. To accomplish this, the current study will evaluate different tests including: brain imaging (MRI), body fluid samples (blood and cerebrospinal fluid), skin biopsy, cognitive ability, and behavioural questionnaires. The study team hopes that this information can be used to guide diagnosis and better predict disease progression in patients with mild cognitive impairment and and early dementia.

Eligibility Criteria:
Inclusion Criteria:

* Referring diagnosis of MCI or early dementia
* Age 40-95
* Study partner who has some weekly contact with patient. Some of the neuropsychological assessment require collateral from close contacts to assess cognition and functioning. Since neurodegenerative diseases can be associated with reduced cognition, including reduced awareness of one's own impairments, participants will be assessed for their capacity to consent at all study visits.
* Must, in the opinion of the site investigator, be able to complete most study procedures.

Exclusion Criteria:

* Participants who are not able to complete the majority of assessments in the opinion of the PI are excluded from the study. Exclusion criteria are evaluated at the site investigator's discretion; if the site investigator believes that the participant's symptoms are due to causes other than neurodegeneration, despite the presence of an exclusionary condition, the investigator may overrule the exclusion.
Drug Use Investigation for AMERGE (Naratriptan Hydrochloride) Tablet

The study is designed to investigate the information on safety and efficacy of naratriptan tablets on Japanese subjects with migraine headache during Japanese post-marketing surveillance period.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with migraine headache
* Must use naratriptan tablets for the first time

Exclusion Criteria:

* Subjects with hypersensitivity to naratriptan
* Subjects with history, symptoms, or signs of myocardial infarction, ischemic cardiac disease, or variant angina
* Subjects with history of peripheral vascular disorder
* Subjects with history of cerebrovascular disorder or transient ischemic attacks
* Subjects with uncontrolled high-blood pressure
* Subjects with severe hepatic function disorder or renal function disorder
* Subjects taking ergotamine, ergotamine derivative containing product, or 5-HT1B/1D agonist
Effects of a Computerized Cognitive Stimulation Intervention Adapted to the Level of Cognitive Reserve

Normal ageing presents subtle cognitive changes that can be detected before meeting the criteria for Mild cognitive impairment (MCI). Older people with low cognitive reserve and who receive limited cognitive stimulation are at greater risk of deterioration. In this regard, cognitive stimulation (CS) has been identified as an intervention that reduces this risk, provided that its design considers the differences in the level of cognitive reserve (CR) acquired throughout life and the baseline level of cognitive functioning. The general objective of this study is to evaluate, through a randomized clinical trial, the effectiveness of a computerized cognitive stimulation program, designed and adapted from Occupational Therapy based on the level of cognitive reserve in older adults in Primary Care. 100 participants will be randomized in a stratified manner according to the level of cognitive reserve (high/low), assigning 50 participants to the control group and 50 participants to the intervention group. The intervention group will carry out a computerized cognitive stimulation intervention designed and adapted from occupational therapy according to the level of cognitive reserve, through the "stimulus" platform. The main result expected to be achieved is the improvement of higher brain functions. As secondary results, the investigators expect that those cognitive aspects most vulnerable to ageing will decrease more slowly (in areas such as memory, executive function, attention and processing speed) and that the cognitive reserve of the participants will increase, in addition to being able to balance gender differences in these aspects. The investigators think that these results can positively impact the creation of adapted, meaningful and stimulating CS programs in older adults to prevent MCI and experience healthier ageing.


Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 60 years.
* With score in Lobo's Mini-cognitive Examination (MEC-35) (Lobo, A., Escolar, V., Ezquerra, J., \& Seva Díaz, 1979) between: 28-35 points (Friedman et al., 2012; Vinyoles Bargalló et al., 2002).
* Non-institutionalized persons, belonging to the health centers where the study was conducted.
* With a minimum educational level (knowing how to read and write).
* Who do not present hearing, visual or communication difficulties that would prevent them from completing the cognitive training.

Exclusion Criteria:

* People with mild cognitive impairment or Alzheimer's disease (AD).
* People with significant functional impairment.
* People who have received any type of professionalized cognitive stimulation therapy in the last year.
* People with significant psychiatric conditions, such as major depressive disorder or schizophrenia.
* People who are taking medications that may adversely affect cognitive function, such as anticholinergics, tranquilizers and anticonvulsants.
Techniques to Reduce the Severity and Frequency of Emergent Reactions

The objectives of this study are first to determine if the power of suggestion will decrease the frequency and severity of emergence reactions after procedural sedation and analgesia with ketamine in the setting of the emergency department. Second, to determine if people dream about what they were thinking about when they were induced with ketamine.

The proposed research will be single blinded (patient) randomized controlled trial with a retrospective component to test the hypothesis that the power of suggestion will reduce the frequency and severity of emergence reactions, even in the setting of the emergency department.

The study will be conducted in the emergency department at CHRISTU Spohn Shoreline Hospital. CHRISTUS Spohn Shore hospital is the region's primary acute care center. It houses the Chest Pain, Stroke, and Cancer Centers of CHRISTUS Spohn, and the only level II trauma center in south Texas. It is a major teaching affiliate of Texas A\&M medical school, and serves an inner-city population.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age
* Required need for procedural sedation and analgesia

Exclusion Criteria:

* Age\< 18
* Hypertension
* Raised Intracranial pressure
* Major psychological disorders
* Procedures involving laryngel manipulations
* History of Laryngeal sapsm History of adverse reactions to ketamine
Biomedicines and Bacterial Translocation in Spondyloarthritis

The aim of this project is to evaluate the effect of anti-TNF and anti-IL17 biotherapies on bacterial translocation in patients with NSAID-resistant axial spondyloarthritis.

Axial spondyloarthritis is a common inflammatory rheumatic disease and its management is based on the use of NSAIDs and biotherapies (anti-TNF and anti-IL17 antibodies). Its pathophysiology involves the digestive mucosa. The colon of patients with spondyloarthritis is the site of asymptomatic inflammation. This inflammation results from dysbiosis, which is responsible for activation of innate immunity linked to bacterial translocation phenomena. Dendritic cells are then activated and the immune response is polarized towards the IL23/Th17 axis. This translocation is secondary to an increase in colonic permeability. The increase in digestive permeability allows translocation of bacteria or bacterial fragments, primarily lipopolysaccharide (LPS).

Some proinflammatory cytokines (TNF, IFNγ, and IL23) cause an increase in digestive permeability. IL17 produced in the digestive mucosa has two different effects. Indeed, two types of colonic T cells produce IL17: regulatory T Helpers 17 producing IL10 and IL17 and inflammatory T Helpers 17 producing IL17 and IFNγ.

The investigators hypothesize that biotherapies decrease bacterial translocation. They suspect a lesser effect of anti-IL17 compared to anti-TNF because of the potential inhibition of Treg17 lymphocytes.

Eligibility Criteria:
Inclusion Criteria:

* Axial spondyloarthritis (2009 ASAS criteria)
* NSAID arm: Responding to any class of NSAID and not likely to initiate biotherapy
* anti-TNF/anti-IL-17 arms: Need to introduce a biomedical drug according to current recommendations (objective signs of inflammation, i.e. MRI sacroiliitis or increased CRP, and failure of two NSAIDs of different classes)

Exclusion Criteria:

* IBD already diagnosed by a gastroenterologist or suspicion of IBD (bloody diarrhea)
* Previous exposure to a biomedical drug (anti TNF or anti IL 17).
* Antibiotic use in the 3 months prior to inclusion
* Contraindications for treatment with anti-TNF or anti-IL17 (for all patients)
Prognostic Value of Surem TRAF3IP2 Level in Patients With Acute Myocardial Infarction

To evaluate the prognostic value of surem TRAF3IP2 levels in patients with acute myocardial infarction

Previous study had concluded that TRAF3IP2 plays a causal role in atherosclerotic plaque development and vulnerability in mice. However, no human data was available. In the present study, patients diagnosed with acute myocardial infarction who receive coronary angiography will be enrolled. Their surem TRAF3IP2 levels will be tested using ELASA. The association of surem TRAF3IP2 levels with the major adverse cardiac events will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with acute myocardial infarction
2. patients received coronary angiography
3. invasive management within 72 h of hospital admission

Exclusion Criteria:

1. NYHA III-IV
2. malignant tumor
3. acute infection
4. thyroid dysfunction
5. Life expectancy of b1 y
6. Unsuitable for PCI
Risk Adapted Beacopp Regimen for Standard and High Risk Hodgkin Lymphoma

.This study is trying to address change of chemotherapy dosage according to individual patient response to initial cycles of chemotherapy in order to reduce cumulative dose of chemotherapy.The study includes patients with early unfavorable and advanced hodgkin lymphoma. Patients with low risk were started with standard beacopp and only high risk patients were started with escalated beacopp.Following 2 cycles of therapy the patients were reassessed.Based on scintigraphy results decision was made regarding further therapylative chemotherapy for early responders and maximize dose intensity for late responders.

Patients were eligible if they had early unfavorable disease or patients who presented with stage III or IV disease .Pt assigned to receive 6 cycles of Bleomycin Etoposide, Doxorubicin, Cyclophosphamide Procarbazine, Prednisone (BEACOPP) or increased dose BEACOPP. (IDB). Patient with Stage I or II with ³4 sites of disease, age ³50, ESR³50 "B" symptoms lymphocyte depleted histology "E" site, or bulky disease were defined as early unfavorable disease and were given standard BEACOPP (SB). Those with I, II B or bulky disease or Stage III, IV were defined according the IPS. Increased dose BEACOPP (IDB) cycles of therapy was initiated only to patients with IPS of 3 or more risk factors (high risk) Standard BEACOPP (SB) cycles were initiated to those with a score of 0-2 (standard risk). All patients had baseline GA67 or hybrid PET\\CT scan at diagnosis and post first cycle for gallium scan or second cycle for hybrid PET\\CT. Upon the scan results therapy was planned and given for addition of 4 cycles. Those with negative scan received cycles of SB as of the third cycle. Dose was reduced to level I to III if patient was hospitalized due to fever and neutropenia of 5 days or longer or pt had an episode of sepsis with unstable vital signs.

Patient with residual uptake interpreted as positive scan had additional cycles of IDB for a total of 6 cycles

Eligibility Criteria:
Inclusion Criteria:

* stage I-IIA/B with adverse prognostic or III-IV disease
* Age 18 and Over
* Performance status ECOG 0-3
* Hematopoietic WBC at least 4000/mm3(unless documented bone marrow involvement)
* Hepatic bilirubin no greater then 5 mg/dL
* RENAL:Creatinine no greater than 2.0mg/dL
* not pregnant or nursing
* Fertile patients must use effective contraception
* HIV negative
* No other malignancy within the past 5 years

Exclusion Criteria:

-
A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients

The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation.

A 52-week, Multi-center, Open label, Single arm, Phase 3 Study to Evaluate the Efficacy and Safety of Hepabulin IV in HBsAg positive Liver Transplantation recipients

Eligibility Criteria:
Inclusion Criteria:

* HBsAg Positive candidate for HBV-related liver transplant
* Primary, single organ recipients
* written informed consent

Exclusion Criteria:

* acute renal failure, Serum creatinin \>1.5\*ULN
* severe cardiac disease or other significant disease
* HAV, HCV or HIV positive
* Immunoglobulin A deficiency.
* History of hypersensitivity to Human Immunoglobulin.
* History of cancer within 5 years. (without HCC)
* History of alcohol or/and drug abuse.
* History organ transplantation.
* Within 30 days, participation in another clinical trial and use of an investigational product.
* Subject suffer from any acute or chronic medical, surgical or psychiatric condition or laboratory abnormality that, may increase the risk associated with the study participation or investigational product administration, or may interfere with the interpretation of study result.
Study of Labetuzumab Govitecan in Participants With Metastatic Colorectal Cancer

The goal of this clinical study is to determine the dosing and safety of labetuzumab govitecan (formerly known as IMMU-130; hMN-14-SN38, antibody-drug conjugate) in participants with colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed colorectal adenocarcinoma.
* Stage IV (metastatic) disease.
* Previously treated with at least one prior irinotecan-containing regimen for colorectal cancer.
* Adequate performance status (Eastern Cooperative Oncology Group (ECOG) 0 or 1).
* Expected survival \> 6 months.
* Carcinoembryonic antigen (CEA) plasma levels \> 5 ng/mL.
* Measurable disease by computed tomography (CT) or Magnetic resonance imaging (MRI).
* At least 4 weeks beyond treatment (chemotherapy, immunotherapy and/or radiation therapy) or major surgery and recovered from all acute toxicities.
* At least 2 weeks beyond corticosteroids.
* Adequate hematology without ongoing transfusional support (hemoglobin \> 9 g/dL, absolute neutrophil count (ANC) \> 1,500 per mm\^3, platelets \> 100,000 per mm\^3).
* Adequate renal and hepatic function (creatinine ≤ 1.5 x IULN, bilirubin ≤ institutional upper limit of normal (IULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x IULN or 5 x IULN if know liver metastases).
* Otherwise, all toxicity at study entry ≤ Grade 1 by National cancer institute common terminology criteria for adverse events (NCI CTC) v4.0.

Exclusion Criteria:

* Women who are pregnant or lactating.
* Women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period.
* Individuals with Gilbert's disease or known central nervous system (CNS) metastatic disease.
* Individuals with CEA plasma levels \> 1000 ng/mL must be approved in advance by the Sponsor.
* Presence of bulky disease (defined as any single mass \> 10 cm in its greatest dimension).
* Individuals with active ≥ grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
* Individuals with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while individuals with other prior malignancies must have had at least a 3-year disease-free interval.
* Individuals known to be human immunodeficiency virus (HIV) positive, hepatitis B positive, or hepatitis C positive.
* Known history of unstable angina, myocardial infarction, or congestive heart failure present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
* Known history of clinically significant active chronic obstructive pulmonary disease (COPD), or other moderate-to-severe chronic respiratory illness present within 6 months.
* Infection requiring intravenous antibiotic use within 1 week.
* Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
The Effect of a Plant Sterols-Enriched Low-Fat Milk on Lipid Profile in Healthy Southern Chinese (COME-PASS)

This is a randomized, double-blind, single-center, two-arm, placebo-controlled clinical trial that examine the effect of the consumption of a plant sterols-enriched low-fat milk. Half of the participants will consume of 1.5g of plant sterols daily as provided by two servings of the plant sterols-enriched low-fat milk product for 3 consecutive weeks, while the other half will consume placebo low-fat milk.

Plant sterols are the naturally occurring functional equivalent of mammalian cholesterol. Plant sterols differ structurally from cholesterol by a methyl or ethyl group in their side chains and are not synthesized by the human body. These structural differences render them minimally absorbable in the intestine. It has been consistently reported that dietary incorporation of plant sterols(1.5-2 g/day) reduces serum low-density lipoprotein cholesterol (LDL-C) levels with minimal adverse events. The hypochoelsterolemic effects of plant sterols is explained by an inhibition of cholesterol absorption, which is ascribed to a competition with intestinal cholesterol for incorporation into mixed micelles, although other possible mechanistic explanation have been proposed.

Eligibility Criteria:
Inclusion Criteria:

* Southern Chinese male or female ≥ 18years.
* In good general health as evidenced by medical history
* Have the ability to understand the requirements of the study, provide written informed consent, including consent for the use and discloser of research-related health information, and comply with the study data collection procedures. Provide signed and dated informed consent form

Exclusion Criteria:

* Subject with familial hypercholesterolemia
* Ingestion of drugs known to interfere with lipid profiles, such as hormone replacement treatment, diuretics, beta-blockers, statin or other hypochoelsterolemic drug treatment
* Smoking \> 10 cigarettes/day
* Subject with heavy alcohol intake (Alcohol \> 3 glasses wine, or 2 beers, or 1 shot hard alcohol/day)
* Having milk intolerance or dislike
* Having major diseases such as diabetes (type I and type II), renal or liver diseases
* Subject presenting known allergy or hypersensitivity to milk proteins, soy and peanut
* Subject refusing to stop the consumption of plant sterols-enriched products if any during the study (other than the studied product)
* Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
* Subject currently involved in a clinical trial or in an exclusion period following participation in another clinical trial
* Pregnancy or lactation
* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.