cyrilzakka/clinical-trials huggingface dataset:
Health-Related Quality of Life in Upper Secondary Schools in Denmark

Measuring Quality of Life in an upper secondary school in Denmark

The Child Health Utility 9 Dimension (CHU9D) is a relatively new health-related quality of life (HRQoL) instrument for use in children and young people. CHU9D has recently been translated and linguistic validated into Danish.

The objective of this study is twofold. Firstly, the investigators wants to examine the feasibility of using the Danish version of CHU9D to assess the HRQoL in young adults. Secondly, the investigators wants to analyse the association of wellbeing, happiness with the school and the learning environment with the students HRQoL in the Northern Danish Region of Denmark.

Eligibility Criteria:
Inclusion Criteria:

* Students at the Higher Commercial Examination (HHX) and Higher Technical Examination (HTX) at the Technical College in Aars.

Exclusion Criteria:

* There will be no exclusion criteria concerning diseases or conditions for these school students.
The Effects of Dietary Phosphate Intake on Calciotropic Hormones and FGF23.

The purpose of this study is to determine the effects of different amounts of phosphorus in the diet on hormones that control phosphorus and bone health both in people who are healthy and in ones who have moderate kidney disease.

Chronic kidney disease affects 11% of the US population; over half of those affected have skeletal manifestations of their renal disease. Renal osteodystrophy is a complex disease, in which multiple mineral systems and related hormones play a role, including phosphate homeostasis. Phosphate regulation primarily depends on renal handling of phosphate, which is partly controlled by parathyroid hormone and vitamin D. However, other mediators in this system clearly exist. Recently, evidence has been accruing that one such factor may be FGF23, a protein produced by osteogenic cells. States of excess FGF23 are associated with marked phosphate wasting, hypophosphatemia, osteomalacia, and inappropriately low calcitriol. FGF23 levels are measurable in healthy humans and markedly elevated in patients who require hemodialysis, although its physiologic role in either state is unknown. Some retrospective evidence suggests that FGF23 is affected by phosphate intake. We are performing a study to gather data describing the response of FGF23 to changes in dietary phosphorus intake in healthy men and women and in men and women with moderate renal insufficiency. The specific aims of this pilot study are: 1) To examine the physiologic effects of alterations in dietary phosphorus on FGF23 in healthy subjects; 2) To examine the physiologic response of FGF23 to dietary phosphorus alterations in patients with moderate renal failure; and 3) To assess whether serum levels of 1,25-dihydroxyvitamin D vary inversely with those of FGF23 when dietary phosphate is changed. The proposed research plan is a dietary intervention trial in which we will study the response of serum FGF23 levels to diets with varying phosphorus contents in healthy adults and adults with moderate renal insufficiency.

Eligibility Criteria:
Inclusion Criteria:

HEALTHY SUBJECTS:

* Men 21-65 years of age;
* Premenopausal women over 21 years of age taking oral contraceptives;
* Postmenopausal women less than 65 years of age;

CHRONIC KIDNEY DISEASE SUBJECTS:

* Men 21-65 years of age;
* Premenopausal women over 21 years of age taking oral contraceptives;
* Postmenopausal women less than 65 years of age;
* Creatinine clearance between 30 and 59 ml/min/1.73 m2 as calculated using the equation derived from the Modification of Diet in Renal Disease (MDRD) study.

Exclusion Criteria:

* Medications affecting bone metabolism;
* Abnormal liver or GI function;
* Extreme electrolyte abnormalities;
* BMI \>30 kg/m2.
Prostate SABR With Intra-Prostatic SABR Boost

Stereotactic Ablative Radiation (SABR/SBRT) will be prescribed to a dose of 35 Gy in 5 fractions, once weekly to prostate with a simultaneous intra-prostatic boost to the MR detected nodule up to 50Gy. The pelvic lymph nodes and seminal vesicles will also receive 25 Gy in 5 weekly fractions.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed prostate adenocarcinoma
* High-risk prostate cancer, defined as at least one of: T3, Gleason 8-10, OR PSA \> 20 ng/mL
* Willing to give informed consent to participate in this clinical trial

Exclusion Criteria:

* Prior pelvic radiotherapy
* Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
* Contraindication to prostate MRI
* No evidence of castrate resistance (defined as PSA \< 3 ng/ml while testosterone is \< 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.
* Definitive extrapelvic nodal or distant metastatic disease on staging investigations.
A Non-interventional Study to Identify Children and Adolescents With ADHD and With or Without mGLuR Mutations

This is a non-interventional study in children and adolescents (ages 6-17 years) with attention deficit hyperactivity disorder (ADHD) to assess CNVs in specific genes involved in glutamatergic signaling and neuronal connectivity. The screening in this study will be conducted through a combination of online and site performed activities.


Eligibility Criteria:
Inclusion Criteria:

1. Parent/legally authorized representative (LAR) can speak and read English fluently, have provided informed consent and agree to be contacted for an interventional study prior to being genotyped.
2. Subject is 6 to 17 years of age (inclusive) at the time of informed consent.
3. Parent/LAR confirms that the subject has been diagnosed with or been told by a doctor that their child has ADHD.
4. Parent/LAR confirms that the subject is not pregnant and/or breastfeeding.

Exclusion Criteria:

1. Parent/LAR confirms that the subject has been diagnosed with any of the following conditions (aside from ADHD): conduct disorder, anxiety disorder, major depression, autism spectrum disorder (ASD), bipolar disease, psychosis, hypertension, seizure disorder, syncope, or other serious cardiac problems.
2. Aside from your child's current ADHD medication (if applicable), parent/LAR confirms that the subject is currently taking any of the following medications: antidepressants, anti-anxiety medications, anti-psychotics, and/or mood stabilizers.
3. Parent/LAR confirms that the subject has been genotyped previously in the MDGN-NFC1-ADHD-001, MDGN-NFC1-ADHD-101 clinical study.
Virtual Path Planning for Image-guided Needle Interventions

Philips Healthcare has added a virtual path planner to the current commercially available XperGuide software platform and that has the potential to significantly reduce dose during image-guided needle interventions.

The investigational device is used for image guidance by virtually planned path and X-ray data.

Eligibility Criteria:
Inclusion Criteria:

* Patients at any age who are referred for a clinically indicated XperGuide interventional procedure.
* The informed consent has been signed by the participant, parent or legal guardian as appropriate.

Exclusion Criteria:

-Pregnant patients.
Health Course of Patients Undergoing Per os Anti-cancer Therapy.

During the last few years, the medical care of oncohematologic cancers diagnosed patients was shaken by the arrival of new therapies : targeted therapies. Very efficient, these therapies use the oral pathway in most cases, and are taken at home. These treatments show plenty of drug interactions and side effects aren't rare and require, in their own, a rigorous follow up in order to reduce their occurrence, intensity and their impact on patients' quality of life. A bad management of the treatment could lead to an inacceptable toxicity, or to its premature interruption.

With all the new administration and follow up strains in mind, we want to elaborate the medical pathway structure for these patients by reinforcing the nurse coordination and by integrating another healthcare professional : the hospital pharmacist, which is a professional especially implicated in the drug delivery, the control of drug interactions and medical advices relative to the given drug.

Private healthcare professionals (referring physicians, pharmacists, private nurses), unsufficiently trained and informed about these new treatments and their side effects, are asking for further information concerning the drugs prescribed to their patients, and are willing to keep open a communication line for the home follow up.

These patients, who are autonomously taking their medication, are in need to be informed and supported to insure the good management of the drug, while taking in account their environment, their knowledge of their cancer and treatment and also of all the issues that could occur during their therapy, in order to resolve them.

We propose a multidisciplinary medical care taking place at the very beginning of an oral therapy treatment, in order to ensure the security of the drug administration. Patients and healthcare professionals will be closely followed during the first two treatment cycles. After this, side-effects incidence are less frequent and the usual oncohematologic follow up is sufficient.


Eligibility Criteria:
Inclusion Criteria:

* Patient who treated at the Groupe Hospitalier Mutualiste for an oncohematological pathology, and for which targeted oral therapy is indicated (Tarceva, Afinitor, Sutent, Ibrance, Revlimid, Zydelig, Imbruvica)
* Patient who has given its written consent
* Patient affiliated or beneficiary of social security system

Exclusion Criteria:

* ECOG performance score \< 2
* Patient already included in an interventional clinical research protocol
* Patients protected by French law from clinical research inclusion (pregnant, in labour, breastfeeding, legally protected, under judiciary or administrative liberty deprivation)
Physical Activity Coaching in Chronic Obstructive Pulmonary Disease (COPD)

This study is designed to explore a new approach to help people with chronic obstructive pulmonary disease (COPD) become more physically active. Through weekly telephone sessions with a health coach utilizing motivational interviewing, participants will be empowered to set goals for increased physical activity (emphasis on walking). The objective of the study is to determine if telephone-based health coaching is a reasonable and effective way to increase physical activity, as measured by a gold-standard activity monitor, in people with COPD.


Eligibility Criteria:
Inclusion Criteria:

* Men and women age 40 years and older
* Current or former cigarette smoker of at least 10 pack-years
* Diagnosis of COPD stage II to IV COPD as documented by pulmonary function testing (FEV1 \<80% predicted, FEV1/FVC ration \<0.71) within the past 24 months
* Able to ambulate independently or with a walking aid (wheeled or standard walker or cane)

Exclusion Criteria:

* Unable to walk without assistance of another person
* patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move out of the state, are not able to be contacted by telephone
* patients with an inability to provide good data or follow commands (patients who are disoriented or have a severe neurologic/psychiatric condition)
Percutaneous Internal Ring Suturing Versus Conventional Laparoscopic Repair of Congenital Inguinal Hernia

Background:comparison between percutaneous internal ring suturing vs Conventional Laparoscopic Repair of Congenital Inguinal Hernia in male patients. Methods : this is a prospective randomized study including 109 male patients with 120 CIHs Patients were randomly categorized into two groups. Group A were subjected to laparoscopic disconnection of the hernia sac and narrowing of the internal ring (IR). Group B underwent PIRS. The intended primary outcome was recurrence within 1 year, besides comparing the two techniques regarding operative time, efficacy, safety, cosmetic outcome, and postoperative complications.

Introduction Since the 1990s laparoscopy has gained popularity in the management of Congenital inguinal hernia (CIH). Several laparoscopic techniques have been described, including laparoscopic disconnection of the hernial sac with narrowing of the internal ring (IIR) which was described to mimic the open technique, and the extraperitoneal approach involves using various types of needles under laparoscopic guidance to percutaneously secure a suture circumferentially around the internal ring, thus obliterating the sac opening. This study compared the short-term outcome of percutaneous internal ring suturing (PIRS) versus laparoscopic disconnection of the hernial sac with narrowing of the internal ring in children.

Materials and Methods: This study included 109 male patients with 120 CIHs during the period from May 2022 to May 2024. Patients were randomly categorized into two groups. Group A were subjected to laparoscopic disconnection of the hernia sac and narrowing of the internal ring (IR). Group B underwent PIRS. The intended primary outcome was recurrence within 1 year, besides comparing the two techniques regarding operative time, efficacy, safety, cosmetic outcome, and postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

* male patients
* age of 6 month to 5years
* reduciable congenital inguinal hernia either unilateral or bilateral.

Exclusion Criteria:

* incarcerated CIH
* recurrent CIH
* patients with undescended testis,
* patients with hydrocele,
* patients with chronic comorbidity such as congenital heart disease and severe chest troubles
Phase III Multicenter Double Blind Controlled Trial of Human Immune Globulin Therapy in Previously Untreated Patients With Chronic Inflammatory Demyelinating Neuropathy

OBJECTIVES:

I. Compare and evaluate the response to treatment with intravenous human immune globulin (IVIG) or placebo in previously untreated patients with chronic inflammatory demyelinating polyneuropathy.

PROTOCOL OUTLINE: This is a double blind, randomized, controlled study. Patients receive either intravenous human immune globulin (IVIG) or placebo infused at a rate of 40 mL/hr, increasing every 30 min to a maximum of 100 mL/hr daily over 6 to 8 hours for 2 days. On day 2, infusions of IVIG or placebo are delivered at the highest dose tolerated on day 1.

On day 21, patients receive another IVIG or placebo infusion. Following day 42, patients may choose to continue infusions of IVIG every 21 days for 2 doses.

Patients not receiving additional treatment are released from study. Patients are evaluated on days 10, 21, and 43.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Chronic inflammatory demyelinating polyneuropathy (CIDP) characterized by:

Progressive or relapsing disease or chronic stable course with elevated cerebrospinal fluid protein with normal cell counts Acquired demyelination on electrophysiologic studies Segmental demyelination on nerve histology

--Patient Characteristics--

* Not pregnant No significant medical disorders
Evaluating Adjunctive Cryopreserved Amniotic Membrane Treatment in Herpes Simplex Dendritic Keratitis

To prospectively evaluate the effectiveness of Prokera Slim in adults with primary or recurrent herpetic epithelial keratitis in terms of visual function, corneal opacity, time to resolution, cost of care, number of patient visits.

Cryopreserved amniotic membrane (AM) contains anti-inflammatory, anti-scarring and antiangiogenic effects known in treating many ocular surface diseases. This notion is further strengthened by many studies showing that amniotic membrane can effectively control inflammation in HSV stromal keratitis in a murine model of HSV necrotizing keratitis and surgical application in \~7 human studies of epithelial and stromal HSV keratitis with or without an adjuvant antiviral therapy. More importantly, PROKERA SLIM in conjunction with oral acyclovir has been shown to facilitate the ease of early intervention to accelerate restoration in herpetic keratitis in 2 case series of 5 eyes. However, a formal prospective study has not been performed.

Eligibility Criteria:
Inclusion Criteria:

1. The subject (male or female) is at least 18 years of age.
2. The subject is presenting with primary or recurrent herpetic dendritic epithelial keratitis based on investigator judgement
3. The subject is presenting with acute (within 30 days) herpetic dendritic epithelial keratitis
4. The subject is willing to comply with all study procedures and is able to consent.

Exclusion Criteria:

1. Clinical signs of a cause other than herpes simplex virus
2. Presence of corneal ulcer with or without microbial infection
3. Lid surface abnormalities or conjunctival scarring that affect lid function in either eye
4. Atopic disease
5. History of penetrating keratoplasty
6. Active stromal keratitis or iritis
7. Presence of systemic or ocular infection or inflammation that is not related to herpes simplex virus (such as Sarcoidosis, Cogan syndrome, atopy, Lyme disease, Syphilis, mumps, Epstein-Barr virus)
8. Ocular surface malignancy
9. History of recent ocular surgery/trauma, which could affect corneal sensitivity, e.g., corneal transplantation, LASIK
10. A medical or ocular condition, or a personal situation, which in the principal investigator's opinion, is not appropriate for participation in the trial
11. Current enrollment in another interventional drug or device study or participation in such a study within 30 days of anticipated entry into this study
12. Not capable of providing informed consent
Long-Term Safety Study of MT-2412 in Japanese Patients With Type 2 Diabetes

The purpose of this study is to evaluate the safety and efficacy of co-administration of Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 52 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and have inadequate glycemic control.


Eligibility Criteria:
Inclusion Criteria:

* Men or women age ≥20 years old
* HbA1c of ≥7.0% and \<10.5%
* FPG of ≤ 270 mg/dL
* Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before treatment period

Exclusion Criteria:

* Patients with type I diabetes, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes
* Patients with serious diabetic complications
* Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
* Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
* Patients with severe hepatic disorder or severe renal disorder.
Implementation Effectiveness and Safety of Tenofovir Gel Provision Through Family Planning Services

The purpose of this study is to assess the effectiveness of an implementation model which integrates tenofovir gel provision into existing family planning services.

The CAPRISA 008 trial is a two-arm, open-label, randomized controlled trial that is being conducted at the CAPRISA eThekwini and CAPRISA Vulindlela Clinics and their neighboring public sector family planning services in KwaZulu-Natal, South Africa. Up to 700 consenting sexually active, HIV-uninfected women aged 18 years and older who previously participated in an antiretroviral (ARV) prevention study will be enrolled and followed for a maximum 30 months. All women will be provided with 1% tenofovir gel but will be randomised to either receive their gel through a public sector family planning services with 2-3 monthly provision (intervention arm) or through the CAPRISA research clinics with monthly provision (control arm).

All women in the trial will be provided with the standard package of HIV prevention and reproductive health services. Participants in both study arms will be provided with a supply of single-use, pre-filled applicators of 1% tenofovir gel. While in the study, participants will be advised and supported to follow the CAPRISA 004 pre- and post-dosing strategy, namely BAT24, where the first dose of tenofovir gel is applied within 12 hours before anticipated coitus and a second dose as soon as possible but within 12 hours after coitus, with a maximum of two doses of gel in a 24-hour period.

The primary objective of this trial is to assess the effectiveness of an implementation model for tenofovir gel provision through family planning services.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Women who previously participated in an ARV prevention study
* Currently utilizing or agreeing to attend designated public sector family planning services
* Able and willing to provide first person informed consent to be screened for, and to enroll in, the study
* Able and willing to provide adequate locator information for study retention purposes
* Sexually active (at least one coital act in the last 3 months prior to screening)
* HIV negative (by HIV testing performed by study staff within 30 days of enrollment)
* Negative pregnancy test performed by study staff within 21 days of enrollment
* Agree to use a non-barrier form of contraceptive
* Agree to adhere to study visits and procedures

Exclusion Criteria:

* Has a creatinine clearance \< 50ml/min
* Has any other condition that, based on the opinion of the Investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives