Kornimate/medical-research-clean huggingface dataset:
anrs 12406 evva study

Conditions: HIV-1-infection

Summary: anrs 12406 evva is an observational, longitudinal and monocentric study evaluating the virological success rate in hiv-infected adolescents on antiretroviral therapy in cameroon. the main objective of the study is to estimate the rate of virological suppression among adolescents on antiretroviral therapy for more than 6 months in cameroon

at the end of 2017, hiv-aids affects more than 36 million people worldwide, more than three-quarters of whom live in sub-saharan africa, and a quarter of the infections are among young people and adolescents. every hour, 4 adolescents (aged 15-19) are newly infected with hiv in the world, and 3 of them are adolescents. three infections occur in sub-saharan africa, and for five adolescents living with hiv, there are seven girls (aged 10 to 19) in the same situation. this gender disparity increases when adolescents reach adulthood. this group of the population may well deserve the term "key and vulnerable population". in the era of international commitment to end the aids epidemic by 2030, especially to stop new infections, it is essential not to neglect part of the epidemic because it would effectively represent a reservoir for maintaining the epidemic and make these eradication goals impracticable. data on virological success among adolescents on antiretroviral treatment are generally scarce and this is much more striking in central africa. also, information on the frequency of emergence of resistant viruses and the consequences for the effectiveness of available treatments is rare. however, in the absence of such data, it is difficult, if not impossible, to take the right decisions to improve the care and monitoring of adolescents. in addition, the few available data indicate high virological failure rates and high frequencies of drug resistance, which may indicate a need to further investigate virological failure events in this population. this study will be conducted in cameroon among 289 adolescents during 9 months, where access to biological monitoring is a major challenge, especially with low access to viral load testing. the results of this project will inform on the current state of success of arv treatments in this population. moreover, the other goal of this study is to conclude on the need to conduct a larger study at the national or regional level according to the results obtained

Eligibility criteria:
inclusion criteria: * being adolescent (aged 10 to 19) on antiretroviral therapy and followed at the laquintinie hospital (douala cameroon) * hiv-1 infection * duration of antiretroviral therapy ≥ 6 months regardless of antiretroviral regimen * for emancipated adolescents: obtaining informed consent signed by the adolescent * for unemancipated adolescents: * obtaining informed consent signed by the legal representative (parent(s) or guardian(s)) * obtaining the assent of adolescents able to understand the study (maturity and knowledge of hiv status) exclusion criteria: * infection with hiv-1 or hiv-1/hiv2 co-infection

Keywords: virological failure hiv drug resistance adolescents cameroon
automated mechanical peripheral stimulation to treat freezing of gait in patients with parkinson's disease and stn-dbs

Conditions: Parkinson Disease; Gait Disorders, Neurologic

Summary: the objective is to investigate whether amps (automated mechanical peripheral stimulation) is effective in reduction of fog measured via the fog-ac (freezing of gait assessment course) in people with parkinson disease and stn-dbs (subthalamic nucleus deep brain stimulation) in a randomized, double-blind, sham-controlled, cross-over trial

the effects of amps treatment (effective vs sham) will be measured using the fog-ac assessment. patients will be randomized to receive either amps treatment and then sham or sham and then amps. each treatment phase will be 4 weeks of treatment, separated by a 6-week washout period.

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature (appendix informed consent form) * ≥18 years old * diagnosis of parkinson's disease according to the united kingdom brain bank criteria * bilateral stn-dbs for at least 6 months * moderate to severe fog i.e. fog-ac ≥8 pts. exclusion criteria: * known or suspected non-compliance, drug or alcohol abuse, * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, etc. of the participant, * participation in another study with investigational drug within the 30 days preceding and during the present study, * previous enrolment into the current study, * pregnancy * enrolment of the investigator, his/her family members, employees and other dependent persons, * l-dopa induced-freezing (defined by medical history), * dbs-induced freezing (defined by medical history), * clinically relevant depression * clinically relevant cognitive impairments * shoe size greater than 46

Keywords: freezing of gait fog deep brain stimulation parkinson disease
long term follow up of patients who have received gene therapy or gene marked products

Conditions: Severe Combined Immunodeficiency; Malignancy, Hematologic; Neuroblastoma; Neoplasm; Mucopolysaccharidosis I

Summary: this protocol (genefu) provides a mechanism for the 15-year followup period that the fda requires for all participants in gene transfer protocols and assures that adequate followup can be maintained for a wide variety of participants on different individual gene therapy protocols at st. jude children's research hospital. genefu serves as an umbrella protocol for long-term follow-up (ltfu) for recipients of gene therapy/gene marked (gt/gm) products at st. jude children's research hospital. the fda has recommended methods to assess the risk of delayed adverse events after gt/gm and has provided specific requirements regarding the duration and design of ltfu observations. this protocol is intended to provide ltfu in accordance with the fda guidelines for those who received a gt/gm product as part of a st. jude-sponsored clinical trial or compassionate use treatment plan. the protocol calls for a physical examination or general health evaluation and collection of required blood samples annually for up to 15 years after the last receipt of a gt/gm product. goals will be to obtain clinical histories in order to detect late clinical outcomes suggestive of retroviral or lentiviral disease, including but not limited to cancer/second malignancies, neurologic disorders, autoimmune disorders, and hematologic disorders. blood samples will be archived and tested when clinically or scientifically indicated, as in the event of development of a second malignancy. this prospective cohort study will utilize descriptive statistics in the analysis of long-term late effects outcomes. it offers a uniform approach to long-term safety monitoring in research participants who have received a gene-transduced product as part of st. jude-sponsored gt or gm protocols and compassionate use treatment plans.

secondary objectives include the following: to obtain and archive blood samples to 1) detect frequency of vector marking in peripheral blood mononuclear cells when clinically or scientifically indicated, such as in the event of participant development of second malignancy, autoimmune disease, hematologic abnormality, or neurologic event, and; 2) to obtain and archive blood samples to detect and characterize clonal proliferation events occurring in gene transfer trials when clinically or scientifically indicated.

Eligibility criteria:
inclusion criteria: * has received an integrating retroviral or lentiviral vector based gt/gm product at st. jude children's research hospital within the past 15 year time period. patient is no later than 15 years post receipt of gt/gm product.

Keywords: gene therapy
proof of concept treatment study of orally administered vh4004280 or vh4011499 in hiv-1 infected adults

Conditions: HIV Infections

Summary: the primary purpose of the study is to evaluate the antiviral activity of orally administered vh4004280 and vh4011499 monotherapy over 10 days in human immunodeficiency virus (hiv-1) infected treatment-naïve (tn) participants.


Eligibility criteria:
inclusion criteria: * participants who are overtly healthy (other than hiv-1 infection). * screening cluster of differentiation-4 (cd4+) t-cell count greater than or equal to (≥)200 cells/microliter (µl). * documented hiv-1 infection and screening plasma hiv-1 rna ≥3000 copies/milliliter (ml). * treatment-naïve: defined as no antiretroviral therapy received after the diagnosis of hiv-1 infection. prior use of oral pre-exposure prophylaxis (prep) is permitted. prior use of parenteral prep is exclusionary. * has body mass index (bmi) within the range of 18.5-31.0 kilograms per meter square (kg/m\^2). * participants male at birth must use male condoms and participants female at birth who are of childbearing potential must be using acceptable forms of birth control. * participants capable of giving signed informed consent. * participant must be willing and able to start locally accessible and commercially available combination antiretroviral therapy after the monotherapy period. exclusion criteria: * women who are breastfeeding or plan to become pregnant or breast feed during the study. * participants with acute hiv infection. * any evidence of an active centers for disease control and prevention (cdc) stage 3 disease. * untreated syphilis infection. * ongoing malignancy other than certain localised malignancies. * treatment with immunomodulating agents or any agent with known anti-hiv activity. * has exclusionary psychiatric, hepatic, cardiovascular gastrointestinal, renal condition. * participant having any condition which, in the opinion of the investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to take oral medication. * participants having exclusionary electrocardiogram (ecg) findings. * participants who have been exposed to any prohibited medication or vaccine. * participant positive for hepatitis b or hepatitis c. * participants with exclusionary safety laboratory (e.g grade 3 or greater abnormality). * participants who have positive results for illicit drug use, regular use of drugs of abuse and/or excessive alcohol use.

Keywords: hiv-1 vh4004280 vh4011499 treatment naïve phase 2a monotherapy
a study to evaluate vip152 in subjects with relapsed/refractory chronic lymphocytic leukemia or richter syndrome

Conditions: Relapsed Non Hodgkin Lymphoma; Chronic Lymphocytic Leukemia; Refractory Chronic Lymphocytic Leukemia; Richter Syndrome; MYC Amplification; MYC Overexpression; MYC Translocation

Summary: determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (mtd) and recommended phase 2 dose (rp2d) of vip152 as monotherapy or in combination with a btki in patients with chronic lymphocytic leukemia (cll) or richter syndrome


Eligibility criteria:
inclusion criteria: * male or female patients aged \>/=18 years * adequate bone marrow, liver, and renal functions * eastern cooperative oncology group (ecog) performance status of 0 to 2 * diseases as defined below: part1 * subjects with cll with either del(17p) by fish or tp53 mutation who have received ≥1 prior therap(ies) and the last prior regimen must have included venetoclax plus an anti-cd20 antibody and/or a btki and did not produce complete remission. subjects with cll with either del(17p) by fish or tp53 mutation who have received ≥2 prior regimens and are intolerant to btki and/or venetoclax are also eligible. or * subjects with cll transformed to dlbcl who have relapsed after, or been refractory, to at least 1 prior line of therapy for dlbcl part2 * subjects with cll who are currently on an approved btki (monotherapy only) at the dose and schedule per the local label for ≥ 12 months who have only achieved sd, pr or prl exclusion criteria: * active clinically serious infections of grade \> 2; requiring parenteral therapy * subjects who have new or progressive brain or meningeal or spinal metastases. * anticancer chemotherapy or immunotherapy during the study or within one week prior to the first dose of study drug * major surgery or significant trauma within 4 weeks before the first dose of study drug * allogeneic bone marrow transplant or stem cell rescue within 4 months before first dose of study drug; patients must have completed immunosuppressive therapy before enrollment

Keywords: cll leukemia cdk-9 vip152 richter syndrome btki
a pan-cancer screening and diagnosis model based on abdominal ct was established

Conditions: Abdominal Neoplasm

Summary: abdominal noncontrast scan and contrast-enhanced ct were used to establish a screening and diagnostic model for abdominal tumors

secondary objective: to establish a grading model of abdominal tumors based on clinical indicators exploratory objective: to include ct scans in large-scale non-tumor populations for validation and to improve model accuracy certainty

Eligibility criteria:
inclusion criteria: * patients with abdominal tumors: * all patients were pathologically diagnosed with abdominal tumors; * the clinical case data of all patients were complete, and complete follow-up was obtained, with clear information on medical visits, operation time and survival status within 2 years. if the cause of death is unknown, it will be recorded as censored data; * all patients had no history of active abdominal bleeding, no serious infection or other abdominal diseases that affected the observation of ct imaging within 3 months before surgery. * non-tumor population: * all patients have complete clinical case data, complete abdominal ct, no history of malignant tumors, no serious infections or other abdominal diseases that affect the diagnosis and observation of ct imaging. exclusion criteria: * cases in which contrast-enhanced or noncontrast ct images show unclear lesions, with significant noise and artifacts;
a study of n-acetylcysteine (n-ac) in people receiving car t-cell therapy for lymphoma

Conditions: Lymphoma

Summary: the purpose of this study is to test the safety of n-ac when given in combination with yescarta to people with lymphoma. this study will test different doses of n-ac to find the highest dose that causes few or mild side effects in participants.


Eligibility criteria:
inclusion criteria: * patients must be 18 years of age or older * patients who will receive axicabtagene ciloleucel for treatment of lymphoma * patients must have adequate end organ function to be eligible for this study as defined by the following criteria: * ecog performance status 0-2 * hematologic function with anc ≥ 1000, hgb ≥ 8, plt ≥ 50k unless there is disease related hematologic toxicity * renal function with crcr ≥ 40 ml/min or cr ≤ 1.5 x uln * hepatic function with alt/ast ≤ 2.5 x uln, tbili ≤ 1.5 x uln. exclusion criteria: * patients with known allergy to n-ac

Keywords: n-ac n-acetylcysteine lymphoma cd19 car t-cell therapy 21-386 memorial sloan kettering cancer center
follow-up evaluation of photo-dynamic therapy for pituitary tumours

Conditions: Pituitary Neoplasms

Summary: a study to followup patients that have previously been treated for pituitary tumours with either photodynamic therapy or placebo in a previous trial. the study aims to determine whether photodynamic therapy has any long term effect on tumour size, visual fields or endocrinological function.

no patients will receive any medical or procedural treatments in this study, since these have been administered in a previous trial. the previous trial participants will be contacted and asked to attend a clinic or to have a telephone interview, where they will answer a questionnaire. they will be assessed clinically for visual fields, as well as undergoing an mri scan of their head to assess tumour size (unless they have had a scan anyway in the previous 12 months), these tests would ordinarily form part of the routine outpatient workup for patients with pituitary tumours. there is no significant risk to the physical well-being of the patients with any of the methods to be used.

Eligibility criteria:
inclusion criteria: * patients who were previously included in the initial pituitary pdt trial, in addition to those who were randomised as part of the rct arm of the study. these patients have already participated in phase i/ii trials. of note, these patients all have pituitary tumours. exclusion criteria: * patients who were not included in the above mentioned trials. patients included in the original trials who have subsequently died (of any cause).
the effects of the water drinking test on intraocular pressure

Conditions: Glaucoma

Summary: this clinical trial is designed to investigate the efficacy profile of the sensimed triggerfish® during 24-hour iop monitoring in patients with glaucoma or ocular hypertension, done three times at monthly intervals under different therapeutic regimen. this trial will also evaluate the efficacy of sensimed triggerfish® to detect changes in intraocular pressure (iop) after the water drinking test (wdt) will be investigated.

the investigation will recruit male and female patients 18-80 years old and diagnosed with glaucoma or ocular hypertension requiring hypotensive ocular treatment. up to 100 subjects will be enrolled in the study to ensure a minimum of 80 completing three iop fluctuation monitoring sessions. patients will be considered enrolled in the study upon signature of informed consent. a screening visit and three 26-hour iop fluctuation monitoring sessions are planned for each patient. iop monitoring sessions will be carried out in ambulatory mode at 4 week intervals (plus/minus 7 days). all subjects will be monitored during the same period of the day (± 1hr). the expected duration of participation for each patient is of 3.5 days over three to four months. patients will be recruited over a 16-month period. the total expected study duration is 16 months.

Eligibility criteria:
inclusion criteria: * subject is able to comply with the study procedures * 18-80 years old * subjects diagnosed with glaucoma, based on presence of repeatable visual field loss and/or glaucomatous optic neuropathy based on masked review of optic disc stereophotographs and under ocular hypotensive treatment, or diagnosed with ocular hypertension, with an iop of \> 22 mmhg at the screening visit and under ocular hypotensive treatment. * subject has consented to be in the trial * visual acuity of 20/80 or better * ability to understand the character and individual consequences of the study * for women of childbearing potential, adequate contraception * stable anti-hypertensive treatment regimen 4 weeks prior to the screening visit and throughout the study. exclusion criteria * subjects with chronic kidney failure and chronic hear disease * subjects with contraindications for wearing contact lenses * severe dry eye syndrome * keratoconus or other corneal abnormality * conjunctival or intraocular inflammation * eye surgery prior to and throughout the study, except prior uncomplicated cataract surgery and laser a minimum of 3 months prior to the screening visit. * full frame metal glasses during sensimed triggerfish® monitoring * known hypersensitivity to silicone, plaster or ocular anesthesia (proparacaine) * pregnancy and lactation * simultaneous participation in other clinical studies * no patient will be allowed to participate in this trial more than once
neck dissection vs radiotherapy for cervical metastases in advanced hypopharyngeal cancer

Conditions: Hypopharyngeal Carcinoma

Summary: at the time of diagnosis, approximately 60%-80% of patients with hypopharyngeal cancer are found with cervical lymph node metastasis. cervical nodal metastasis is an important prognostic factor in hypopharyngeal cancer. induction chemotherapy is frequently used in advanced hypopharynx cancer. however, sometimes cr was obtained at the tumor's primary site but not in the palpable lymph nodes in the neck, the large cervical lymph node metastasis poorly responded to induction chemotherapy in a considerable percentage of patients. at present, patients with primary tumor achieved cr preferred to receive definitive radiotherapy no matter cervical lymph node metastasis sd or progression. but, radiotherapy was poor effective to the big cervical lymph node metastasis, because the inner of big cervical lymph node metastasis was hypoxic and necrosis. the investigators conducted a prospective, randomised trial to compare neck dissection with definitive radiotherapy for advanced hypopharyngeal cancer cervical lymph node metastasis with poor response to induction chemotherapy.


Eligibility criteria:
inclusion criteria: 1. ability to understand and the willingness to sign a written informed consent document 2. age≥ 18 and≤ 75 years 3. histological/ cytological/ imaging examination proven hypopharyngeal squamous-cell carcinoma in preoperative assessment 4. advanced hypopharyngeal cancer with metastatic cervical lymph node more than 2cm in diameter 5. epog≤1,kps≥ 70 6. no contraindication of surgery and radiotherapy 7. no serious disease history of the heart, liver, kidney, lung and other important organs 8. expected survival period≥ 12 months 9. good compliance exclusion criteria: 1. inability to provide an informed consent 2. other malignancy tumor history,(except for cured skin basal cell carcinoma and papillary thyroid carcinoma) 3. serious cardiovascular, liver, respiratory, kidney and neurologic and psychiatric disease with clinical symptoms 4. the patient has received prior surgery or radiotherapy (except for biopsy) 5. the patient has received chemotherapy or immunotherapy 6. pregnant or lactating women 7. other disease requiring simultaneous surgery or radiotherapy

Keywords: hypopharyngeal cancer neck dissection induction chemotherapy cervical lymph node metastasis definitive radiotherapy
a study of a plant-based diet in people with monoclonal gammopathy of undetermined significance (mgus) or smoldering multiple myeloma (smm)

Conditions: Monoclonal Gammopathy of Undetermined Significance; Smoldering Multiple Myeloma

Summary: this study will test whether a plant-based diet is practical (feasible) for overweight people with monoclonal gammopathy of undetermined significance (mgus) or smoldering multiple myeloma (smm). the researchers will decide how practical the diet is by looking at how much weight participants lose and how well they are able to stick to the diet. the researchers will also determine whether the diet is effective in preventing multiple myeloma in participants. in addition, they will look at how safe the plant-based diet is for participants, and see if the diet affects participants' quality of life.


Eligibility criteria:
inclusion criteria: * bmi ≥25 * confirmed diagnosis of mgus or smm * m spike (immunoglobulin) ≥0.2 g/dl or abnormal free light chain ratio with increased level of the appropriate involved light chain * secretory disease * age ≥18 years * willingness to comply with all study-related procedures * ecog performance status of 0-3 * interest to learn to cook plant based recipes exclusion criteria: * patients that already follow a whole foods plant based or vegan diet (ovo-lactovegetarian diets are not excluded) * legume allergy * severe allergies, such as anaphylactic shock to peanuts * concurrent participation in weight loss/dietary/exercise programs * mental impairment leading to inability to cooperate * enrollment onto any other therapeutic investigational study * concurrent pregnancy * patients with a known diagnosis of diabetes mellitus will not be excluded but will need to be followed regularly with an endocrinologist/primary care physician during the trial period. * positive hbv, hcv, hiv pcr testing * non english speaking * ≥ grade 2 electrolyte abnormalities as defined by ctcaev5.0 (need to be resolved before enrolling on study) * if in the opinion of the investigator there maybe any concerns regarding the ability of the patient to complete the study safely

Keywords: plant-based diet nutrition 21-135