cyrilzakka/clinical-trials huggingface dataset:
Ante-hypophyseal Dysfunctions in Children Following Moderate to Severe Traumatic Brain Injuries

Annual incidence of severe traumatic brain injuries (TBI) varies from 180 to 300 out of 100.000. Mortality or severe sequelae risk is increased 8 fold after a TBI. Studies in adults showed an ante-hypophyseal deficit in 28 to 68 % of patients with a TBI. The most common deficit is Growth Hormone Deficit (GHD); followed by gonadotropic and corticotropic (AdrenoCorticoTropic Hormone (ACTH)) insufficiencies. Thyrotropic deficits (Thyroid-Stimulating Hormone (TSH)) are less frequent. From a pathophysiological point of view, the lesional mechanism responsible for hypopituitarisms would be a damage of hypophyseal vessels or hypothalamic-pituitary vessels. The frequency of pituitary deficits and the potential beneficial effects of replacement therapy on quality of life, tiredness, loss of energy and productivity, justify the systematic detection of the deficits in patients with moderate to severe TBI.

Study hypotheses :

At the present time, the lack of data in children does not give us the opportunity to affirm that one part of the symptoms showed by children with post-TBI neuropsychological sequelae, are linked to pituitary deficiency and that they can be improved with a replacement therapy.

Firstly, it is essential to better understand the natural history of post-TBI pituitary deficiencies, studying the connexion between observed deficiencies in acute and late phase of sequelae.


Eligibility Criteria:
Inclusion Criteria:

* children from 2 months to 16 years
* in the intensive care unit
* TBI : moderate (Glasgow Coma Scale (GCS) between 9 and 12) to severe (GCS \<9), whatever the mechanism involved
* informed consent form signed by parents

Exclusion Criteria:

* obesity (Body Mass Index (BMI) \> 97th percentile for the age)
* patient already under replacement therapy.
* patient taking AntiEpileptic Drugs (AEDs)
* patient with long-term systemic corticotherapy
* history of neurological disease or learning difficulties
* no covered by a national health insurance
AmbassADDOrs for Health Study

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;
PEG-IFN in HBV Patients With Incomplete Response to NA

Treatment with a nucleoside analogue and subsequent viral decline has shown to partially restore immune hyporesponsiveness in chronic hepatitis B patients. Recent pilot studies investigating whether the effect of lowering viral load with nucleoside analogue therapy prior to the initiation of peginterferon results in higher sustained off-treatment responses showed contradictory findings.

The aim of this study is to investigate sustained off-treatment response to peginterferon alfa-2b in chronic HBeAg-positive hepatitis B patients who are pretreated with nucleos(t)ide analogues, thereby lowering viral load


Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis B (HBsAg positive \> 6 months)
* HBeAg positive, anti-HBe negative within one month prior to initiation of peginterferon alfa-2b
* HBV DNA \< 2000 IU/ml during nucleos(t)ide analogue treatment within one month prior to initiation of peginterferon alfa-2b
* Compensated liver disease
* Age \> 18 years
* Written informed consent

Exclusion Criteria:

* Treatment with any investigational drug within 30 days of entry to this protocol
* Severe hepatitis activity as documented by ALT\>10 x ULN
* History of decompensated cirrhosis (defined as jaundice in the presence of cirrhosis, ascites, bleeding gastric or esophageal varices or encephalopathy)
* Pre-existent neutropenia (neutrophils \<1,800/mm3) or thrombocytopenia (platelets \<90,000/mm3)
* Co-infection with hepatitis C virus, hepatitis D virus or human immunodeficiency virus (HIV)
* Other acquired or inherited causes of liver disease: alcoholic liver disease, obesity induced liver disease, drug related liver disease, auto-immune hepatitis, hemochromatosis, Wilson's disease or alpha-1 antitrypsin deficiency
* Alpha fetoprotein \> 50 ng/ml
* Hyper- or hypothyroidism (subjects requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/exclusion criteria are met)
* Immune suppressive treatment within the previous 6 months
* Contra-indications for alfa-interferon therapy like suspected hypersensitivity to interferon or Peginterferon or any known pre-existing medical condition that could interfere with the patient's participation in and completion of the study.
* Pregnancy, breast-feeding
* Other significant medical illness that might interfere with this study: significant pulmonary dysfunction in the previous 6 months, malignancy other than skin basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g. HIV positivity, auto-immune diseases, organ transplants other than cornea and hair transplant)
* Any medical condition requiring, or likely to require chronic systemic administration of steroids, during the course of the study
* Substance abuse, such as alcohol (\>80 g/day), I.V. drugs and inhaled drugs in the past 2 years.
* Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study
Efficacy of Allopurinol and Dypiridamole in Acute Mania

This study aims to evaluate the potential antimanic efficacy, safety and tolorability of the purinergic agents allopurinol and dipyridamole as an add-on treatment to lithium in a sample of 180 drug-free manic patients enrolled in a double-blind, placebo-controlled design.

Men and women ages 18 to 65 years, who were inpatients with a diagnosis of manic episode were recruited at the emergency room of Espirita Hospital of Porto Alegre (HEPA), Brazil (n=180) between September 2004 and 2006. The presence of manic episode was confirmed using SCID-I and the severity of episode was evaluated using the Young Mania Rating Scale (YMRS) and the Clinical Global Impression scale (CGI). Patients were required to present a score\>22 on the YMRS at screening to be included. Subjects presenting rapid cycling, mixed episodes and comorbidities with axis I psychiatric disorders were not considered for inclusion. All subjects presented good physical health determined by physical exam, medical history, blood screening and electrocardiogram. Patients were randomly assigned to allopurinol 600 mg/day, dipyridamole 200mg or placebo as add-on medication lithium treatment for a 4-week, double-blind trial. The use of adjunctive antipsychotic agents (typical or second-generation drugs) was not allowed during the double-blind period. Adjunctive diazepam was used when necessary (maximum dose=20mg/day). Raters (psychiatrists) were trained together to establish reliability (YMRS =0.90). This study was approved by the Espirita Hospital Ethics Committee-IRB. Written informed consent was obtained from all patients and/or family member. Possible adverse events were monitored weekly during the follow-up period. Regarding primary outcome measures, we compared the percentage of responders according YMRS score decrease of at least 50% among allopurinol, dipyridamole and placebo groups, using fisher exact test. Also, the percentage of improvement from baseline to endpoint was obtained and compared among groups using analysis of variances (one-way ANOVA) with Duncan post-hoc test. Remission rates (YMRS scores \< 12) were also analyzed. P values \< 0.05 were considered statistically significant. Besides completers analysis, intention to treat and LOCF were employed to include data from drop-out patients who were evaluated at visit 3. Possible correlations were measured using Pearson test. Fischer exact test and X2 evaluated response and remission rates. Data are presented as mean ± standard deviation.

Eligibility Criteria:
Inclusion Criteria:

* The presence of manic episode was confirmed using SCID-I and the severity of episode was evaluated using the Young Mania Rating Scale (YMRS) and the Clinical Global Impression scale (CGI). Patients were required to present a score\>22 on the YMRS at screening to be included.All subjects presented good physical health determined by physical exam, medical history, blood screening and electrocardiogram

Exclusion Criteria:

* Subjects presenting rapid cycling, mixed episodes and comorbidities with axis I psychiatric disorders were not considered for inclusion. .
Changes in Everyday Life After a Tai Chi or Eurythmy Intervention in Elderly People at Risk of Falling: a Qualitative Exploration as a Sub-Study of the ENTAiER Study

The ENTAiER fall prevention study investigates the efficacy and safety of eurythmy therapy and tai chi in older people with chronic diseases and an increased risk of falls. In the course of the ENTAiER study, the participants observed changes in themselves and in their everyday life and described them in conversation, which could not be recorded with the research methods used. A qualitative exploration of these subjectively experienced changes among participants of the ENTAiER study will be conducted as part of a sub-study. For this purpose, group interviews will be conducted.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled and randomized participant of ENTAiER main study
* Written informed consent for participation in EYT_13 sub-study
* Participation in eurythmy or tai chi intervention for 24 weeks (-28d/+21d) (the standard care group will be time-equated to eurythmy and tai chi)

Exclusion Criteria:

* Early termination of the intervention (less than 20 weeks) (the standard care group will be time-equated to eurythmy and tai chi)
Once-Daily Investigational Nasal Spray In Adults And Adolescents With Seasonal Allergic Rhinitis (SAR)

Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as (hay fever), it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes. The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with seasonal allergic rhinitis (SAR) caused by ragweed pollen.

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 2 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Seasonal Allergic Rhinitis (SAR)

Eligibility Criteria:
Inclusion criteria:

* Must be outpatients.
* Diagnosis of SAR.
* Literate in English or native language.

Exclusion criteria:

* Have a significant concomitant medical condition.
* Use corticosteroids or other allergy medications during the study.
* Use tobacco products.
The Effect of the Nursing Intervention Program on Adolescent Problematic Internet Users

In this study; The effect of the nursing intervention program (education enriched with web 2.0 tools based on the Health Belief Model) on problematic internet use, loneliness and family harmony in adolescents who use the internet with problems will be determined.

In this study; The effect of the nursing intervention program (education enriched with web 2.0 tools based on the Health Belief Model) on problematic internet use, loneliness and family harmony in adolescents who use the internet with problems will be determined. This research is a cross-sectional randomized controlled experimental study with a cross-sectional type in the first stage and a pretest-posttest in the second stage.

Eligibility Criteria:
Inclusion Criteria:

1. Being a secondary school student,
2. Agreeing to participate in the research,
3. Being open to communication and cooperation,
4. Can use web 2.0 tools via smartphone or computer

Exclusion Criteria:

- Having a score of less than 50 points and above 79 points on the Internet addiction scale.
Accuracy of the Optical Diagnosis of Small Colonic Polyps Using the Nice Classification

Adenomas and hyperplastic polyps are polypoid lesion and may occur at any location in the colon. At the present moment, all polyps should be resected endoscopically, although only adenomas, but not hyperplastic polyps have the potential to develop colorectal cancer. This approach enables the conduction of microscopic investigations of the lesions. By today, only the pathological diagnosis can distinguish exactly between adenomas and hyperplastic polyps. Some studies have investigated the value of the socalled optical biopsy method. Optical biopsy means the visual assessment of the polyp and the determination of a diagnosis solely on behalf of optical criteria. This method is conducted in real time during colonoscopy. If it can be shown, that endoscopist using optical biopsy are able to predict histopathological diagnoses of colonic polyps sufficiently this would possibly lead to simplification of diagnostic procedures. For instance, it would be conceivable to resect hyperplastic polyps and small adenomas and discard them without further assessment by a pathologist. Gastroenterological societies demand for a 90 percent accordance between diagnoses set by endoscopists and pathologists as a prerequisite for the implementation of the optical biopsy method.

In this study we want to proof that the use of a new narrow-band imaging (NBI) tool (Exera III, Olmpus) is capable to rise accuracy of optically ascertained diagnoses of colonic polyps. NBI is a light filter tool which can be activated by pressing a button at the endoscope. NBI function leads to an endoscopic picture which appears blue and enables endoscopists to better assess surface structures and vascular patterns.

In a prospective randomised multicenter setting we plan to conduct colonoscopy in 380 patients. Half of the patients will be examined without use of NBI (control arm). In these cases colonoscopists will assess optical diagnosis of polyps without turning on the NBI tool. If polyps are detected in patients belonging to the intervention arm NBI will be used and optical diagnosis will be determined using the NICE (NBI International Colorectal Endoscopic) classification. All polyps will be resected and send to pathology for further microscopic assessment. After completing the trial we aim to compare accuracy of the optical diagnosis in both groups. Our hypothesis is, that by using the new NBI tool accuracy (accordance between optical and histopathological diagnosis) can be increased from 78% to 90%.


Eligibility Criteria:
Inclusion Criteria:

* medical indication for colonoscopy
* age \>18 years
* written consent given by patient

Exclusion Criteria:

* age \< 18 years
* patients denying written consent
* pregnant women
* ASA class IV, V and VI
* known contraindication for polyp resection
* indication for colonoscopy: preknown adenoma/polyp/carcinoma
* indication for colonoscopy: emergency (e.g. severe rectal bleeding)
Long-term Recurrence and Other Complications Requiring Surgery Following Primary Ventral Hernia Repair

Nationwide, registry based cohort studies on all complications requiring surgery following primary ventral hernia repair

Cohort based on patients registered in the Danish Ventral Hernia Database. Through cross-linking at an individual level, all subsequent operations will be identified in the Danish National Patient Registry. For all potentially related reoperations, patient charts will be retrieved and manually reviewed. Furthermore cross-linkage with the Danish Civil Registration System to retrieve information on civil status. Follow up from time of operation for primary ventral hernia repair (index operation) until reoperation, death, emigration or end of follow up (December 31, 2023), whichever comes first.

Eligibility Criteria:
Inclusion Criteria:

* Operation for primary ventral hernia repair registered in Danish Ventral Hernia Database
* Known body mass index and smoking status at time of surgery, as registered in the Danish Ventral Hernia Database

Exclusion Criteria:

* Hernia type misclassification (based on manual medical file review)
Evaluation of Arthroscopic Reconstruction of the Anterior Cruciate Ligament by One Night Hospital Stay or by Day Surgery: a Randomised, Prospective Clinical Trial

Patients who suffered from a rupture of the Anterior Cruciate Ligament with instability of the knee joint, will be treated with an operative ACL-reconstruction. One group of patients will stay one night in the hospital and go home the other day (Group I). The other group of patients will go home the same day of surgery (Group II). All patients will undergo the same arthroscopic reconstruction of the ACL. Anesthesia will be performed on each patient in a classic manner. At the end of the surgery each group of patients will be randomly divided in two subgroups: one group will get an injection in the knee joint with 20 ml of physiological fluid (Group Ia en IIa), the other group will get an injection in the knee joint with 20 ml of chirocaine 0.125%, a widely used pain-medicine (Group Ib and IIb). This will happen in a double blind, randomized way. The whole procedure takes about one hour. After surgery patients are brought to the recovery room and are observed every 30 minutes for the duration of 4 hours. Before being brought to their rooms, patients will have to fill in a VAS: Visual Analogue Scale, to determine their pain. After being brought to their rooms, the patients will have the choice of going home the same day or staying in the hospital for one night, according to the amount of pain they are in. That moment it will be possible to switch groups. Patients who go home the same day of surgery will be contacted by phone the day after to fill in a question form. Patients who were admitted for one night will be seen before their leave to fill in the same question form.


Eligibility Criteria:
Inclusion Criteria:

* Patients who suffered from a isolated rupture of the Anterior Cruciate Ligament with instability of the knee joint will be included in the study.
* Patients with a meniscal tear that can be sutured will also be included. Partial meniscectomies are accepted.

Exclusion Criteria:

* Patients with chronic laxity (longer than 9 months), associated collateral laxity (grade III), subtotal or total meniscectomy, infection or inflammatory disease of the knee joint or large cartilage lesion will not be included in the study.
MIROCALS: Modifying Immune Response and OutComes in ALS

MIROCALS is a phase II study of ld-IL-2 as a therapeutic agent for ALS. A randomized (1:1), placebo-controlled, double-blind, parallel group trial will be carried out to assess ld-IL-2 safety and clinical efficacy on survival and functional decline in newly diagnosed ALS patients treated for 18 months. Randomization will be stratified according to (i) country (n = 2 levels: UK, France) and (ii) site of onset (n= 2 levels: bulbar vs limb onset).

The primary objective to evaluate the clinical efficacy and safety of the experimental drug (ld IL-2) over an 18 months period in order to establish the proof of concept (PoC) that modifying immune responses through the enhancement of regulatory T cells modifies the rate of ALS disease progression.

The secondary objectives of MIROCALS are:

To validate a new phase-II study design to improve the efficiency of drug development in ALS with early determination of drug response using established biomarkers (BMs).

The aims of this new trial design are:

(i) To shorten future trials duration in ALS using an early drug responding surrogate marker of disease activity; (ii) To establish the proof of mechanism (PoM) of the tested drugs; (iii) To identify drug responder status.

Additional exploratory objectives are:

(i) Deep immune \& inflammatory phenotyping (ii) Brain biomarkers (iii) Genomics and Transcriptomics

Eligibility Criteria:
Main Inclusion criteria

* Patient is 18 years old and less than 76 years old
* Possible, Probable, Probable laboratory-supported or Definite ALS as defined by El Escorial Revised ALS diagnostic criteria
* Disease duration \<= 24 months
* Slow Vital capacity \>= 70% of normal
* No prior or present riluzole treatment
* Lumbar punctures accepted by patient and done

Main Exclusion criteria

* Other neurodegenerative disease that could explain signs or symptoms
* Contra indication for lumbar puncture (history of allergy to xylocaine, presence of contra-indicated treatment, or coagulation test abnormality, clinically significant coagulopathy or thrombocytopenia)
* Non authorized treatment
* Other disease or disorders that could preclude functional assessment, or life-threatening disorders
* Any documented, active, past or present, auto-immune disorders except asymptomatic Hashimoto thyroiditis
* Using assisted ventilation
* Feeding through gastrostomy or nasogastric tube
* Women of child-bearing potential or sexually active man without contraception
* Pregnant or breast feeding woman
* Any clinically significant laboratory abnormality (excepting cholesterol, triglyceride, glucose, CK, ferritin)
* History of documented symptomatic and treated asthma within the past 5 years