Kornimate/medical-research-clean huggingface dataset:
bereaving, but not alone : the development and actualization of a mutual aid group for children who have lost a parent.

Conditions: Mourning,; Grief,; Bereavement.

Summary: the methodology of this clinical trial is based on the realisation of a group intervention with children who lost a parent. interviews preintervention and postintervention with participants will be done as well. the purpose of this study is to answer the following question: "what are the benefits for children who are in the process of bereaving a parent to participate in a group work intervention based on the mutual aid model ?". the aim of the research is to explore the benefits for grieving children to participate in an group work intervention based on the mutual aid model. to do so, the research has three distinct objectives : 1) to develop and apply a program of group work interventions for grieving children based on the mutual aid model ; 2) to explore the extent to which participation in the group facilitates changes in the children's discourse about death and the loss of their parents, and 3) to examine, from the children's own perceptive, the possible impact that their participation in the group have on their experience of bereavement.


Eligibility criteria:
inclusion criteria: * children between 8 and 12 years old. * children who had lost a parent within 3 months and two years before the beginning of the group intervention. exclusion criteria: * children who experimented death of his parent by suicide.

Keywords: bereaved children, mutual aid group, death, group intervention.
vascular reparative mechanism in diabetes

Conditions: Diabetic Retinopathy

Summary: the purpose of this research study is to study blood stem cells in diabetic patients and normal patients. we would like to better understand if these cells, called endothelial precursor cells (epcs), are not working as expected in people with diabetes. we would like to see if the function of these cells can predict the development of diabetic retinopathy. diabetic retinopathy is an eye disease associated with diabetes in which the cells of the retina are damaged. it can cause blurred vision, vision loss, blindness or possible bleeding in the retina. even with current treatments, the quality of life for people with diabetic retinopathy is much reduced.


Eligibility criteria:
inclusion criteria: * men or women 18 years or older * 39 type 1 or type 2 diabetic patients * 13 with mild retinopathy * 13 with moderate retinopathy * 13 with severe, nonproliferative retinopathy * 39 age and sex matched healthy controls exclusion criteria: * current pregnancy as evidence by a urine pregnancy test as the blood from a pregnant female will influence the results of the laboratory tests

Keywords: diabetes retinopathy
safety and pharmacokinetics of recombinant factor xiii in patients with congenital factor xlll deficiency

Conditions: Congenital Bleeding Disorder; Congenital FXIII Deficiency

Summary: this trial was conducted in the united states of america (usa). the aim of this trial was to investigate safety and pharmacokinetics of escalating single doses of catridecacog (recombinant factor xiii, rfxiii) in patients with congenital factor xiii deficiency.


Eligibility criteria:
inclusion criteria: * documental congenital fxiii deficiency * normal platelet count and clotting parameters * adequate renal and hepatic function * if female and of child-bearing potential, negative serum pregnancy test within 7 days of enrollment * if a sexually active male or a sexually active female of child-bearing potential, agreement to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits * negative drug and alcohol screens exclusion criteria: * received blood products or fxiii concentrates within 4 weeks of study enrollment * known antibodies to fxiii * hereditary or acquired coagulation disorder other than fxiii deficiency * previous history of autoimmune disorders involving autoantibodies e.g., systemic lupus erythematosus * previous history of thromboembolic events e.g., cerebrovascular accident or deep vein thrombosis or administration of any antithrombotic or antiplatelet drugs within 7 days of study enrollment * received treatment with any experimental agent within 30 days of study enrollment * any surgical procedure in the 30 days prior to enrollment * donated blood within 30 days prior to enrollment
study of ambulatory respiratory assist device in chronic obstructive pulmonary disease patients

Conditions: COPD; Chronic Obstructive Pulmonary Disease

Summary: the study is a two-part small scale, open-label, pilot study to evaluate feasibility and proof-of-concept for a respiratory assist medical device. the study population will consist of severe chronic obstructive pulmonary disease (copd) subjects.


Eligibility criteria:
inclusion criteria: 1. moderate to severe copd (by ats criteria) 1. fev1/fvc \<0.70 2. fev1 \< 60% predicted exclusion criteria: 1. physical limitation that prevents walking for 6 minutes (e.g. lower extremity amputation, arthritis limiting function, significant angina, etc...) 2. lung pathology not explained by copd, which may limit functional capacity (e.g. pulmonary fibrosis, malignancy, history of lung reduction surgery, etc...) 3. pregnancy 4. age \<18
pharmacokinetic comparison of efanesoctocog alfa vs other ehl-rfviii products in participants with severe haemophilia a

Conditions: Hemophilia A

Summary: sobi.bivv001-003 is an open-label, 2-period, fixed sequence study for intra-participant comparison of the pk profiles of efanesoctocog alfa and the extended half-life rfviii products damactocog alfa pegol or turoctocog alfa pegol after a single i.v. injection in previously treated males, 18-65 years of age, with severe haemophilia a. participants who are receiving treatment with damoctocog alfa pegol (n\~12) or turoctocog alfa pegol (n\~12) will be enrolled in the study. the study will start with a screening period (up to 28 days), including a wash-out period prior to start of the actual study period. during the the first visit, a single dose of damactocog alfa pegol or turoctocog alfa pegol (corresponding to the participant's pre-study treatment) will be administered. a pk sampling period will follow over 7 visits. following completion of the pk sampling of the original treatment regimen, the patients will be given a single dose of efanesoctocog alfa at visit 8, after which a new pk sampling period will follow (visit 8-15). the primary objective for the study is to compare the half-life of efanesoctocog alfa with that of the two comparator drugs after a single iv. injections. secondary objectives include comparison of area under the curve for efanesoctocog alfa vs. the two comparator drugs, characterization of pk parameters for all three drugs as well as well as to evaluate safety and tolerability of a single iv. injection of efanesoctocog alfa.


Eligibility criteria:
inclusion criteria: * participant must be male, 18 to 65 years of age, inclusive, at the time of signing the informed consent form (icf). * severe haemophilia a, defined as \<1 iu/dl (\<1%) endogenous fviii activity, as documented in historical medical records from a clinical laboratory demonstrating \<1% fviii coagulant activitiy or a documented genotype known to produce severe haemophilia a. * previous treatment for haemophilia a with any marketed recombinant and/or plasma derived fviii for at least 150 exposure days. * currently receiving treatment with damoctocog alfa pegol or turoctocog alfa pegol at screening. exclusion criteria: * any history of a positive inhibitor test, defined as \>0.6 bethesda units (bu)/ml in at least two consecutive bethesda inhibitor assays, or any value greated than or equal to the lower sensitivity cut-off for laboratories with cut-offs for inhibitor detection between 0.7 and 1.0 bu/ml. family history of inhibitors will not exclude the participant. * positive fviii inhibitor result (assessed by central laboratory), defined as ≥0.6 bu/ml at screening.

Keywords: haemophilia a blood coagulation disorder efanesoctocog alfa fviii coagulation protein disorder pharmacokinetics
study of safety and tolerability of pdr001 in combination with sorafenib and to identify the maximum tolerated dose and/or phase 2 dose for this combination in advanced hepatocellular patients

Conditions: Hepatocellular Carcinoma

Summary: a two part study to determine the maximum tolerated dose and/or recommended phase 2 dose of pdr001 in combination with sorafenib in patients with advanced hepatocellular carcinoma in first line. there will be a dose escalation part and a dose expansion part.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed advanced (unresectable and/or metastatic) hcc * patients with advanced hcc not amenable for surgical or loco-regional treatment * at least one measureable tumor lesion that that has not been previously locally * patients with current cirrhotic status of child-pugh class a only (5-6 points with total bilirubin \< 2 mg/dl for dose-escalation) with no encephalopathy and no clinical ascites (ascites controlled by diuretics is also excluded in this study). * patient has an eastern cooperative oncology group (ecog) performance status of 0 or 1 * patient must meet required laboratory values at the screening * normal electrocardiogram at screening exclusion criteria: * known fibrolamellar hcc, sarcomatoid hcc, or mixed cholangiocarcinoma and hcc * invasion of the main portal vein and/or tumor involvement in more than 50% of the liver (applicable only for the dose-escalation part) * patients with portal-caval shunts * prior or concomitant systemic anti-cancer treatment for advanced disease * systemic chronic steroid therapy (≥ 10mg/day prednisone or equivalent) or any immunosuppressive therapy 7 days prior to planned date for first dose of study treatment. topical, inhaled, nasal and ophthalmic steroids are allowed. * cardiac or cardiac repolarization abnormality * patients with active hepatitis b infection (hbsag positive) that are not receiving antiviral treatment are excluded * patients with positive test for hepatitis c ribonucleic acid (hcv rna) * loco-regional treatment within 4 weeks prior to initiation of study treatment.

Keywords: hcc hepatocellular carcinoma hepatocellular carcinoma (hcc) pdr001 liver cancer immunotherapy liver malignant hepatoma hepatocellular cancer advanced hepatocellular carcinoma (hcc) advanced liver cancer liver cancer progression sorafenib anti-pd1 first line
soluble corn fiber and calcium utilization in adolescents

Conditions: Osteoporosis

Summary: the purpose of this study was to determine the effect of soluble corn fiber on calcium absorption and retention and gut microflora in adolescent boys and girls.

in a previous study, soluble corn fiber (scf) was found to greatly enhance calcium utilization and bone properties in a growing rat model. because factors that enhance bone density and mineral content can potentially result in a skeleton that will resist fracture later in life, it is important to investigate this potential in adolescents. therefore, the objective of this study was to determine the effect of scf on calcium absorption and retention in adolescent boys and girls. a second objective of this study was to assess whether additional dietary fiber leads to changes in gut microflora which may influence calcium absorption. during this two-phase metabolic camp participants consumed packages of fruit snacks supplemented with either 0 or 6 grams of soluble corn fiber twice a day during the first phase of the study, and switch to the opposite treatment during the second phase, with a 2-week washout period in between. subjects collected all excreta during both phases and calcium absorption, gut microbiota, height, weight, and bone density were evaluated throughout the 6-week period of the study.

Eligibility criteria:
inclusion criteria: * normal, healthy, white adolescents (hispanic or non-hispanic) * boys age 13-15 * girls age 12-14 exclusion criteria: * abnormal kidney or liver function * malabsorptive disorders * anemia * smoking * history of medications that affect calcium metabolism * body weight outside 5-95 percentile body mass index (bmi) for age * regular consumption of illegal drugs * contraceptive use * pregnancy

Keywords: bone adolescents fiber healthy boys girls camp calcium
ambassaddors for health study

Conditions: HIV Infections

Summary: the goal of the study is to evaluate malkia klabu ("queen club") in tanzania, a loyalty program intervention that creates adolescent girls and young women (agyw)-friendly drug shops where agyw can access hiv prevention services and contraception.

the investigators will conduct a cluster-randomized controlled trial of the malkia klabu intervention in 40 health facility catchment areas (n=60-70 intervention drug shops; \~3-4 drug shops per area) in the shinyanga and mwanza regions of tanzania, plus a mixed-methods, implementation science study to pinpoint supply-side factors influencing effectiveness (e.g., implementation models, intervention fidelity, shop characteristics). malkia klabu is a loyalty card program derived from a youth participatory process with human centered design. young women earn punches on the malkia klabu loyalty card when they make drug shop purchases that upon accrual can be used towards prizes of increasing value. when joining, young women receive a free hiv self test kit (hivst) as an opt out sign-up gift, are invited to interact with a physical display of sexual and reproductive health products, including hivst, and may elect to view videos on a tablet computer about the program, hivst, and contraception. the back of the card displays discreet symbols representing sensitive products available at the shop (e.g., hivst, oral contraception). club members can ask for or point to the product that they want on the card and receive it for free in a discreet bag. referrals are provided to youth-friendly services at a nearby catchment area health facility for hiv testing, treatment and care, and/or contraception.

Eligibility criteria:
the primary unit of analysis are the wards, and within them, the drug shops who will be enrolled based on the following inclusion criteria: inclusion criteria: * wards with no greater than 3 public health facilities; * wards with no less than 4 drug shops; * wards with health facilities that were greater than 20 km from a primary or secondary road; and * drug shop owners and staff in shinyanga and mwanza regions of tanzania who are aged 18 or older;

Keywords: hiv self-testing human-centred design adolescent health contraception drug shops
use of fdg pet/ct to evaluate crohn disease

Conditions: Crohn Disease

Summary: the purpose of this study will permit to determine the role of fdg pet/ct to diagnose crohn disease and recurrence of crohn disease after having compared results of pet/ct's with results of exams routinely performed(colonoscopy and bowel follow through).

crohn disease is an inflammatory disease of the digestive system that may affect the small and large intestines. remission and recurrence clinically characterized its development. when recurrence occurs, a careful examination is necessary in order to determine the extent and the severity of the disease. actual exams performed are invasive and uncomfortable(colonoscopy and bowel follow through). compare to these exams, pet/ct is less fierce to undergo and has less risks. two groups are proposed in this project: 15 patients will be enroll in the active disease group and 15 patients will be enroll in the remission group. in regards of the area and the extent of the disease,pet/ct exams shall provide similar information than what usual tests provide. pet/ct exams shall also provide more information in order to better differentiate inflammatory stenosis from scars stenosis especially located in the small intestine.

Eligibility criteria:
inclusion criteria: * men or women known having a crohn's disease de novo diagnosis or a crohn's disease recurrence based on a seven days questionnaire and a physical exam. * men or women with a past history of crohn's disease but considered clinically in remission based on a seven days questionnaire, a physical exam and a crohn's disease activity index (cdai) score \< to 150. exclusion criteria: * men or women less than 18 years of age * pregnancy * breastfeeding * renal failure * suspicion of a crohn's disease infectious complication (abscess,fistula) * infectious colitis determined at the initial checkup * diabetes * severe allergy to iode contrast

Keywords: crohn disease positron emission tomography colonoscopy
the reduction in glucose stimulated insulin secretion induced by cytokines may be prevented by copper addition - studies in diabetic patients

Conditions: Hyperglycemia; Diabetes

Summary: in the cds rat model, beta-cell dysfunction and pancreatic exocrine damage are triggered and prevented by altering dietary cu content suggesting a chronic and acute role for cu. these abnormalities become apparent when the cds rats are exposed to high sucrose low copper diet, triggering a vicious sequence of events: exocrine damage, recruitment of macrophages expressing il-1beta leading to oxidative stress and even more reduction in the activity of cu-dependent enzymes (chronic effect). when cu levels are re-established (acute effect) they may prevent the inhibitory effect of il-1beta on insulin release and may restore the activity of enzymes inhibited by il-1beta. in this study we will identify humans with marginal cu status that may benefit from copper supplementation to normalize their gsis. these patients will be given a daily cu supplement (3mg/d), or placebo for a period of 6 months. gsis, pancreatic dysfunction and biomarkers of marginal cu status will be measured in different blood components before and every 4 weeks during treatments or placebo.


Eligibility criteria:
inclusion criteria: * diabetic subjects with bmi \< 33 * hba1c \< 8 * plasma copper levels of \< 90 ul/dl exclusion criteria: * patients with bad physical conditions

Keywords: glucose stimulated insulin secretion copper cytokines diabetes reduction in insulin secretion
anti-inflammatory agent in sinusitis

Conditions: Nasal Polyps

Summary: to evaluate the efficacy of an anti-inflammatory agent compared with placebo in relieving signs and symptoms of disease in patients with sinusitis.

this is a phase 2a, single-center, randomized, placebo-controlled, double-blind study that includes 12 weeks of treatment with experimental drug anti-inflammatory agent or placebo tid administered orally. all subjects will be ≥18 years, have sinusitis with persistent symptoms despite standard of care treatment, and have failed a course of steroids in the past.

Eligibility criteria:
inclusion criteria: 1. females must have a negative urine pregnancy test at screening unless documented to have a hysterectomy or be postmenopausal. exclusion criteria: 1. inability or unwillingness of a participant to give written informed consent or comply with study protocol 2. use of any investigational drugs within 30 days of screening. 3. acute infection needing antibiotic treatment at screening.
physical activity and food intake interaction: effect of weight loss in obese adolescent

Conditions: Obesity

Summary: in obese adolescents, energy expenditure (ee) of chronic high intensity muscular exercise (\> 70% vo2max) conducted one hour before a meal causes an anorectic effect at lunch and dinner the same day. the effect on food intake of the distribution of this exercise into two sessions during 24h remains to be determined. in addition, a multidisciplinary load of obesity generates a loss of body weight in the short term, which we do not know the effects on energy balance. to our knowledge, the impact of weight loss on the anorectic effect of muscle exercise is unknown.

two measuring sequences will be carried out before (m0) and after 4 months (m4) of a multidisciplinary treatment program of four months. each sequence will have three days: a "sedentary" day (sed) and two days "exercise" (ex). during the exercise day "ex1", a continuous intense exercise will be conducted for 40 min at 70% vo2max of subjects. during the second day exercise "ex2" teenage realize two exercise representing the same de as ex1 in the morning (50% ed) and late afternoon (50% ed). the multidisciplinary management program (without energy restriction) controlled by institution consists of nutrition education, physical activity and therapeutic education. the exercise program will involve the activity sessions controlled and supervised by a sports educator and interactive sessions using a scientifically validated physical activity program (biomouv®).

Eligibility criteria:
inclusion criteria: * overweight adolescents (over the 90 th percentile of the international cut-off point) * sedentary (according to the ipaq-a questionnaire) * without eating disorders (according to the debq questionnaire) exclusion criteria: * medical or surgical antecedents that are incompatible with the study: cardiovascular, endocrine or digestive disease. * drugs that could interfere with the results of the study * surgical intervention in the 3 months * regular consumption of tobacco or alcohol * patients on a diet with caloric restriction * refusal to sign the consent form * regular practice of sport and intensive

Keywords: obesity appetite regulation insulin sensitivity adolescents exercise
4-step ascot in poi women to promote follicular rescue

Conditions: Premature Ovarian Insufficiency

Summary: to promote follicular development in poi women, g-csf mobilized activated platelet rich plasma will be directly injected into the ovarian medulla. this is a prospective, observational, multicentric, open, pilot-controlled randomized trial which seeks to evaluate the impact of the 4-step ascot technique on the ovarian reserve and reproductive outcomes of poi patients. the study will be developed in two phases. in a first step, poi women will randomized to control or undergo the 4-step ascot technique based on the direct ovarian injection of g-csf mobilized and activated prp. follow up (afc, amh, fsh and e2 determinations) will be developed for 3 month in the controls and for 6 months in the treated and cos initiated if growing antral follicles detected. in the second phase, poi women allocated to control group after completed the follow up period will undergo the 4-step ascot technique, as described in the previous phase but only one ovary will be injected, then they will undergo a 6-month follow up period as described above.


Eligibility criteria:
inclusion criteria: * subjects who meet the following will be considered eligible to participate in the clinical trial: 1. informed consent form dated and signed. 2. age between 18 and 38 (both inclusive) 3. women who meet the eshre criteria for poi \[41\] * presence of menstrual disturbance defined as oligo/amenorrhea for at least 4 months * biochemical confirmation as evidenced by an elevated fsh level \>25iu/l on two occasions \> 4 weeks apart * or fluctuating poi when one of the above criteria is missing. exclusion criteria: * subjects who meet one or more of the following will not be considered eligible to participate in the clinical trial: 1. simultaneous participation in another clinical study that, at the researcher's criteria, could interfere with the results of this study. 2. age ≥ 39 3. autoimmune origin of poi 4. genetic risk factors for por (e.g. turner syndrome, fmr1 premutation, etc); 5. acquired conditions associated with por (e.g. chemotherapy); 6. clinical endometriosis 7. previous ovarian surgery considered as a risk of por 8. previous gonadotoxic treatment 9. known intolerance or allergic reactions to components of the study product, i.e. lactose