cyrilzakka/clinical-trials huggingface dataset:
Understanding the Spectrum of ENPP1 Deficiency and Acute ABCC6 Deficiency

To date, the investigators lack characterization of, the burden of, and the systemic progression of disease in ENPP1 deficiency and ABCC6 deficiency from a patient and/or parent perspective. This study aims to document this characterization, progression as well as the burden of disease. Link to the study registration-

https://www.engagehealth.com/survey/TakeSurvey.aspx?SurveyID=8252n62

This will be a comprehensive, cross-sectional study conducted in approximately 60 individuals (or representative parents of patients) affected by ENPP1 deficiency and the acute form of ABCC6 deficiency. All study participants will complete the RSVP, PRO tools and upload a proof of disease form, followed by an interview conducted by a trained interviewer. It is estimated that each respondent will need up to 60 minutes for the entire process; 20 minutes to complete the RSVP, PRO tools and to upload proof of diagnosis of ENPP1 deficiency or the acute form of ABBC6 deficiency, and approximately 40 minutes to complete the interview and address any follow-up questions if needed.

Eligibility Criteria:
Inclusion Criteria:

1. Participant must be a person with ENPP1 deficiency or the acute infantile form of ABCC6 deficiency who is 18 years or older
2. The parent/caregiver of a patient who has been diagnosed with ENPP1 deficiency or the acute infantile form of ABCC6 deficiency. Please note, parents/caregivers of patients with ENPP1 deficiency who have passed away may participate
3. Confirmed diagnosis of ENPP1 deficiency or ABCC6 deficiency with written proof of disease provided
4. Ability to participate in the RSVP and interview in German, French or English, irrespective of country of residence.
5. Able to grant informed consent
6. Willing to participate in a 40-to-60-minute telephone interview, including follow up questions (if necessary)

Exclusion Criteria:

* Inability to meet any of the inclusion criteria
Stage I Multiple Myeloma Treatment

* Assessment of survival without progression of stage I MM in two groups: arm A: simple survey and arm B: administration of Zoledronate.
* Describe different progression's type noticed and define the prognosis factors of a fast evolution.

RATIONAL:

Multiple Myeloma in spite of therapy progresses mainly due to stem cell auto transplant, still remain a deadly disease. About 2000 new cases are diagnosed every year in France. The asymptomatic Stage I MM according to Duries and Salmon's staging are usually only watch over and only treated at progression. Zoledronate is a third generation aminobiphosphonate (BP), probably the most powerful among the available compounds which received market clearance authorisation in MM with bone damage. During MM, bone's hyper resorption is premature. Interactions exist between tumor growth and bone lyses. Zoledronate's got a proper antimyeloma's action (induce plasma cells apoptosis). We propose to test the early use of Zoledronate as soon as stage I MM to delay progression.

STUDY'S OBJECTIVES:

* PRINCIPAL: Assessment of survival without progression stage I MM in two groups: A arm: simple survey and B arm: administration of BP.
* SECONDARY: Describe different progression's type noticed (bone/extra bone) and define the prognosis factor of a fast stage I MM evolution (standard factors, cytogenetic 13 deletion, bone's restructuring strains: crosslaps, bone alkaline phosphatase), list side effects.

STUDY'S KIND:

Multicenter international randomised trial, open labelled, with individual profit.

CONTRIBUTING CENTERS:

Intergroupe Francophone du Myélome's centers.

INCLUSIONS CRITERIA:

Asymptomatic stage I MM without bone's lesion on the standard radiographs.

STUDY'S MONITORING:

After checking inclusion and non inclusion specifications, the patient will be included in the study and randomized (A arm or B arm) before all treatment. The randomisation will be done by center and stratified according to the diagnostic date witch a year or not.

* Arm A: simple survey as standard practice.
* Arm B: a 15 minutes infusion of Zoledronate every month until progression or a maximum of 18 infusions if no progression. The exams are the one usually defined according to good clinical practices guidelines besides cytogenetic, bone's restructuring strain and serum creatin dosage before each infusion in B arm.

STATISTICAL PURPOSES:

The minimum number of patients required showing a median survival time increase without progression of 26 months in the control arm and 38 months in the BP arm is about 175 patients in each arm for a 48 months inclusion's period, and a monitoring of 24 months after the last inclusion (i.e. a study's length of 6 years).

Eligibility Criteria:
Inclusion Criteria:

* stage I multiple myeloma without bones injuries

Exclusion Criteria:

* abnormal kidney function
* VIH infection
* Hepatic incapacity
* pregnancy
* Associate pathology
AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0] in Japan

The purpose of this study is to evaluate safety and effectiveness of AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\] in Japanese cataract patients.

Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 8 postoperative visits (each eye examined at Day 1-2, Day 7-14, and Day 30-60, with binocular visits at Day 120-180 and Day 330-420 after the second implantation). The second implantation occurred within 30 days of the first.

Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent;
* Diagnosed with bilateral cataracts;
* Planned cataract removal by phacoemulsification;
* Potential postoperative visual acuity of 0.5 decimal or better in both eyes;
* Preoperative astigmatism ≤ 1.5 diopter;
* Clear intraocular media other than cataract in study eyes;
* Calculated lens power within the available range;
* Able to undergo second eye surgery within 30 days of the first eye surgery;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Significant irregular corneal aberration as demonstrated by corneal topography;
* Any inflammation or edema (swelling) of the cornea;
* Diagnosed degenerative visual disorders predicted to cause future acuity losses to a level worse than 0.5 decimal;
* Diabetic retinopathy;
* Previous refractive surgery, retinal detachment, corneal transplant;
* Glaucoma;
* Pregnancy;
* Currently participating in another investigational drug or device study;
* Exclusion criteria during surgery;
* Other protocol-defined exclusion criteria may apply.
Metabolomics Profiling of Coronary Heart Disease

This study sought to assess the diagnostic and prognostic values of metabolomics in coronary artery disease(CAD).

The purpose of this study is to establish a powerful diagnostic and prognostic model based on metabolites in CAD patients.A total of 821 hospitalized patients with CAD and 200 healthy volunteers are enrolled.Specifically, 200 CAD patients from single-centre are regarded as discovery set, 300 CAD patients from multicentre are regarded as validation set. A third independent set including 321patitents is regarded as application set. Untargeted and targeted metabolomics analysis about serum and urine samples in all subjects will be performed using high-performance liquid chromatography coupled with mass spectrometry technology. Univariate and multivariate analysis methods are used to extract and analyze the differential mebabolites. By exploring the relationship between the differential mebabolites and clinical manifestions, a set of diagnostic biomarkers for CAD will be identified. By elucidating the correlation between the differential mebabolites and MACEs, a effective prognostic model will be established. Adverse events are defined as the combined endpoints of death or major adverse cardiovascular events(MACEs) in patients with CAD for at least 1 year follow-up after discharge. In brief, we aim to establish valuabe diagnostic and predictive models based on novel baseline metabolites in patients with CAD.

Eligibility Criteria:
Inclusion Criteria:

* Objective evidence of coronary heart disease risk factors
* Or angina pectoris symptoms
* Or ECG ischemic changes
* Or elevated myocardial enzymes, myocardial radionuclide scanning showing myocardial filling defect, coronary CT showing coronary stenosis ≥ 50%

Exclusion Criteria:

* Older than 80 years and younger than 18 years old,
* Aortic dissection
* Pulmonary embolism
* Malignant tumor
* Autoimmune diseases
* Systemic systemic diseases
* Severe infectious diseases
* Trauma, surgery in the last three months
* Myocarditis, cardiomyopathy, pericarditis, severe congenital heart disease
* Syphilis
* Human immunodeficiency virus / acquired immunodeficiency syndrome
* Hepatitis B and hepatitis C
REtrospective Study of TESTIcular CAncer Patients at the University Magdeburg

Retrospective analysis of treatment outcome and side effects of testicular cancer patients that had been diagnosed at the University Magdeburg from 1960 until 2012.

Creating an ACCESS Windows form based Data Registry for testicular cancer patients.

Relevant data for testicular cancer patients based on EAU-guidelines 2013 and EORTC/RTOG, Lent-SOMA, CTC. All testicular cancer patients who had been histopathologically diagnosed al the Institute of Pathology at the University Magdeburg. About 2000 patients from 1960 until 2012. Postgraduate students collecting data requesting hospital documents, cancer registry of Sachsen-Anhalt, family practitioners and urologists as well as patients. Statistically Analysis with ACCESS and IBM SPSS statistics.

Eligibility Criteria:
Inclusion Criteria:

* testicular cancer histopathologically diagnosed at the University Magdeburg Germany

Exclusion Criteria:

* none.
Effectiveness of Two Exercise Protocols in the Treatment of Patients With Patellar Tendinopathy

Patellar tendinopathy is characterized by anterior pain in the knee, due to the great demand imposed on the extensor mechanism of the knee. Evidence shows that the most appropriate treatment for this condition is the conservative treatment, through strengthening with eccentric exercises. However, a recent editorial proposes a new treatment protocol based on concentric and eccentric exercises, with the initial prescription of isometric exercises. The hypothesis of this study is that the protocol is as good as the eccentric exercises, generating less pain.


Eligibility Criteria:
Inclusion Criteria:

* patients with chronic unilateral patellar tendinopathy confirmed by the reproduction of the pain during the palpation test in the region of the lower pole of the patella
* presence of pain for three months or more
* both genders
* body mass index less than 30 kg/m²
* age between 18 and 40 years
* practice of physical activity on a regular basis
* pain intensity ≥ 3 points on the pain numerical rating scale in the anterior region of the knee, specifically in the region of the lower pole of the patella when performing squatting, jumping or activities with change of direction
* score \< 80 points on the Victorian Institute of Sport Assessment-Patella (VISA-P)
* blazine functional scale between 1 and 3

Exclusion Criteria:

* patients who have previous pain in the knee that does not correspond to patellar tendinopathy
* previous rupture of the patellar tendon (blazin functional scale at level 4)
* previous surgery or infiltration of the patellar tendon in the last six months
* inflammatory diseases
* diabetes mellitus
* lower limbs injuries
* other chronic pain conditions that prevent exercise, such as severe hip and knee osteoarthrosis and joint fractures.
Drug Use Survey (DUS) of Triple Therapy (Methycobal (MBL)+ Myonal (MYO)+ Non-steroidal Anti-inflammatory Drags (NSAID)) on the Symptom Relief of Lumbar DDD in China

The purpose of this study is to observe the overall satisfaction of patients with degenerative disc disease after receiving triple therapy.

DDD (lumbar disc degenerative disease ) patients who have been prescribed triple therapy (MBL+ MYO+ NSAIDs) over 2 weeks of triple therapy were enrolled in the study. They were asked to assess their overall satisfaction degree on triple therapy.

Eligibility Criteria:
Inclusion criteria:

1. lumbar degenerative disc disease (DDD)
2. patients who have been prescribed over 2 weeks of triple therapy

Exclusion criteria:

Patients who do not meet inclusion criteria for DDD
Oral Sedation With and Without Nitrous Oxide

Aims: The objective of the current study was to evaluate the effectiveness of oral midazolam-hydroxyzine with/without nitrous oxide. Design: This was a randomized split mouth, cross over and triple-blinded clinical study. Thirty uncooperative healthy children aged six to nine, whose needed dental treatments.

The purpose of this study was to compare the efficacy of combining oral midazolam-hydroxyzine with/without N2O/O2 in sedating uncooperative schoolchildren undergoing dental treatment. Thirty uncooperative healthy children aged six to nine were randomly selected to receive either one tablet of oral midazolam 7.5 mg and one tablet of hydroxyzine 10 mg with 100% O2 (regimen A), or one tablet of oral midazolam 7.5 mg and one tablet of hydroxyzine 10 mg with 50% N2O/O2 (regimen B) in a crossover design. Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment phase (injection, rubber dam RD, operating high-speed handpiece with touching the tooth without drilling) and the treatment phase (drilling, restoration).

Eligibility Criteria:
Criteria: Inclusion Criteria:

* ASA Classification I.
* minimum weight of 18 kg
* uncooperative children scored 1 or 2 on Frankle Scale.
* requiring nonemergency, bilateral mandibular dental treatments under local anesthesia.

Exclusion Criteria:

* known allergy to midazolam and/or hydroxyzine.
* upper respiratory tract infection with nasal discharge.
New Physitherapy or Alternative Therapy for Hiccup

Hiccup is a common symptom, and it is currently believed that hiccups result from diaphragmatic spasm, with onset ranging from minutes to days. Some patients may terminate on their own, or by ways such as gasping. For some patients with duration longer than 1 day, even longer than 2 days, medications may be needed, mainly: metoclopramide, eperisone hydrochloride tablets, etc. Acupuncture is also effective for some patients. Surgical treatment may be required for some clinically intractable hiccups. However, for the above interventions or treatment means, the current efficacy still needs to be improved.

In the previous clinical experience, we create a new physical clinic protocol which could terminate the hiccup symptom onset instantaneously without adding extra cost to the patient, and the physiotherapy method was convenient and effective. To further validate the superiority, safety of this novel physical therapy regimen, we designed a randomised controlled, prospective, single centre clinical study aimed at comparing the efficacy and safety of the novel physical therapy with conventional pharmacotherapy in patients with hiccups.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Able to swallow water

Exclusion Criteria:

* Allergy or contraindication to the following drugs: metoclopramide et al
* Severe choking on water and difficulty swallowing were present
* Impaired consciousness and inability to cooperate
Study of the Efficacy of Two Doses of Ferrlecit in the Treatment of Iron Deficiency in Pediatric Hemodialysis Patients

This was a multi-center study in iron-deficient pediatric hemodialysis patients, whose legal guardian had provided signed informed consent and satisfied the inclusion and exclusion criteria.


Eligibility Criteria:
Inclusion Criteria:

* Male or female pediatric end-stage renal disease (ESRD) patients.
* Predetermined TSAT and serum ferritin levels
* Receiving chronic hemodialysis therapy with an identified need for repletion iron therapy.
* Receiving a stable epoetin (EPO) dosing regimen.

Exclusion Criteria:

* Receipt of any form of iron supplements during the 4 weeks prior to the first Ferrlecit® dosing.
* Blood transfusion.
* Hypersensitivity to Ferrlecit®.
* Significant inflammatory conditions.
Relationship Between Gluteus Medius Muscle Strength, Balance and Jumping Performance in Professional Female Handball Players

Background Balance and jumping mechanisms are important to prevent injuries in sports such as handball, which require immediately change of direction, jumping and landing strategy. Strong proximal stability is required for accurate jump performance and stability.

Objective To investigate the relationship between gluteus medius strength and static, dynamic balance, horizontal and vertical jump performance.

Design Prospective field trial study.

Setting: Elite women handball players in Turkish Handball Super League. Patients (or Participants): Forty-two elite women handball players from Turkish Handball Super League were included in this study.

Interventions (or assessment of risk factors) The Lafayette Hand-Held Dynamometer was used to determine the strength of the gluteus medius. Single leg hop (SLH) test was used for horizontal jump and Lafayette Vertimetric device was used for vertical jump (VJ) evaluation. Y Balance Test (YBT) was used for the dynamic balance with direction of anterior, posteriomedial, posteriolateral and Standing Stork Test (SST) with eyes closed for the measurement of static balance.

Main outcome measurements Gluteus medius strength with hand dynamometer compared with YBT, SST, VJ and SLH tests.


Eligibility Criteria:
Inclusion Criteria:

* age between 18-40 years,
* playing Handball at least for 5 year as a professional player
* currently free of any lower limb injuries within the last three months
* no previous history of injury or surgery that may affect their lower limbs.

Exclusion Criteria:

* having lower limb injury for more than 1 month;
* having a history of surgery, or chronic and progressive disease in their lower limb
* having scoliosis or any other orthopaedic or neurological problems
Enhanced Post-discharge Home-based Care Program (EHP) for Stroke Survivors in Harbin China

In China, about 70% of stroke survivors are living with the negative consequences of stroke. Post stroke home-based care, a broad concept of rehabilitation, is an important care strategy to enhance recovery and improve quality of life for stroke survivors. However, home-based healthcare service is less available for patients discharged home from hospital. The investigators propose to develop and evaluate a home-based nursing intervention program to provide tailored and timely support to post-stroke patients returning to their daily livings at home after hospitalization. The enhanced post-discharge home-based care intervention is coupled with pre-discharge coaching and post-discharge home follow-up, focusing on functional recovery and self-care skills. This project has the potential to improve the quality of life and the related outcomes of stroke survivors, compared to usual care.

This project will empirically test an innovated care delivery model, an enhanced post-discharge home-based care program (EHP) to address the challenges facing China on post-stroke care. The study will adopt a randomized controlled trial design to assess the effects of the EHP compared with usual care for post-discharged stroke survivors. Economic evaluation will be parallel with the trial.

Eligible participants will be recruited from the neurology units of a large general hospital in Harbin, China. Consented participants will be randomly assigned to receive either usual care or usual care plus EHP intervention. The EHP has two key components: pre-discharge coaching and post-discharge home follow-up which involves five intervention protocols for assessment, treatment and procedures, teaching, guidance and counselling, case management and surveillance, addressing on home-based rehabilitation training and self-care. The 12-week EHP will be provided by a trained nurse case manager with the support of a clinical team. All participants will be follow-up for 12 months with three assessments on study outcomes, including quality of life, self-efficacy, activities of daily living, anxiety and depression, adherence, satisfaction and healthcare utilization after baseline data collection. The incremental cost-effectiveness ratio and cost will also be calculated and compared between the two groups. In addition, focus group interviews will be conducted to gain an in-depth understanding of stakeholders' experience on post-stroke care.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or over
* Acute ischemic stroke diagnosed by a neurologist
* National Institutes of Health Stroke Scale score ≥ 4 or \<16
* Modified Rankin Scale score 2 - 4
* Discharged to their own home
* Premorbid independence
* being able to provide informed consent to participate in the study

Exclusion Criteria:

* Global aphasia or expressive aphasia
* Montreal Cognitive Assessment (MoCA-Beijing) score ≤ 22
* Discharged to rehabilitation settings
* At critical stage of illness or palliative treatment approach being provided
* Conditions likely to interfere with rehabilitation
A Clinical Study of Oglemilast in Patients With Mild to Moderate Persistent Asthma

The study is aimed at evaluating efficacy and safety of oglemilast in the treatment of stable mild to moderate persistent asthma. The study involves two weeks of run in period. This is a placebo controlled study. One of the four treatment arms is placebo. The duration of treatment is 12 weeks.


Eligibility Criteria:
Eligibility Criteria:

* Adult patients with a physician-documented diagnosis of chronic, stable, persistent, mild to moderate asthma (clinical symptoms and documented reversibility of airway obstruction, with an FEV1 of 60% to 85% of the predicted value).

The following criteria must be met at the randomisation visit:

* At least 80% compliance during the single-blind placebo run-in period
* FEV1 between 60% and 85% of the predicted value
* Without asthma exacerbation during the run-in period
* Reversibility: patients are required to demonstrate a ≥ 12% increase in FEV1 (with an absolute improvement in FEV1 of at least 200mL) ≥ 10 min and up to 15 minutes after inhalation of 400 μg salbutamol via a spacer
* Any symptom score being ≥ 1 for at least 4 out of the last 7 days of the run-in
* Use of salbutamol for symptom relief on \> 2 occasions on at least 4 out of the last 7 days of the run-in
A Study to Compare Efficacy and Safety of CT-P55 and Cosentyx in Patients with Moderate to Severe Psoriasis

The goal of this Phase 3 clinical trial is to compare efficacy and safety of CT-P55 with Cosentyx in patients with moderate to severe plaque psoriasis

CT-P55 is a recombinant humanized monoclonal antibody containing the active ingredient secukinumab. CT-P55 is a drug product being developed by CELLTRION, Inc. and being compared to both the EU-approved Cosentyx®. In this study, Efficacy and Safety of CT-P55 will be evaluated in patients with Moderate to Severe Chronic Plaque Psoriasis.

Eligibility Criteria:
Inclusion Criteria:

- Patient has had a diagnosis of chronic plaque psoriasis for at least 24 weeks.

Exclusion Criteria:

* Patient diagnosed with forms of psoriasis other than chronic plaque-type or medication-induced psoriasis.
* Patient who has previously received Secukinumab or any other biologic drug directly targeting Interleukin-17 or the IL-17 receptor.
* Patient who has allergies to any of the excipients of study drug or materials of device or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.