cyrilzakka/clinical-trials huggingface dataset:
A Randomized, Double-blind, Multicenter, Sham-controlled, Safety and Efficacy Study of Conbercept in Patients With mCNV

This study is design to evaluate the effect of conbercept therapy on visual acuity and anatomic outcomes compared to sham injection and durability of response observed in subjects with choroid neovascularization secondary to pathological myopia.


Eligibility Criteria:
Inclusion Criteria:

1. Patients give fully informed consent and are willing and able to comply with all study procedures.
2. In the study eye:

   * Myopia of equal to or greater than -6.00D,and axial length ≥26.5mm.
   * Diagnosis of active subfoveal, juxafoveal, or extrafoveal CNV secondary to high myopia.
   * Visual impairment due to CNV secondary to high myopia.
   * BCVA score ≥24 and ≤73 ETDRS letters (approximately 20/40\~ 20/320 Snellen equivalent).
   * Ocular media of sufficient quality to obtain fundus and OCT images.
3. The BCVA score of fellow eyes ≥ 19 ETDRS letters (approximately 20/400 Snellen equivalent)

Exclusion Criteria:

1. Current vitreous hemorrhage in either eye.
2. Intraocular treatment with corticosteroids within last 3 months or periocular treatment with corticosteroids within last month in the study eye.
3. Active infectious ocular inflammation in either eye.
4. Fibrosis or atrophy involving the center of foveal in the study eye.
5. Any concurrent intraocular condition in the study eye that, in the opinion of investigator, could either require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition.
6. The lesion size ≥30 mm2 in the study eye.
7. Any ocular disorder in the study eye that, in the opinion of the investigator, may confound interpretation of the study results.
8. Uncontrolled glaucoma or cup/disk ratio \> 0.8 in the study eye.
9. Aphakia (excluding artificial lens) in the study eye.
10. Serious amblyopia and amaurosis in the fellow eye.
Medication Reconciliation in Comparison to an Extensive Medication Safety Check

The purpose of this study is to determine wether an extensive medication safety check has a greater impact on the incidence of adverse drug events than medication reconciliation or no intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patient 65 years and older
* written informed consent patient or the legal representative
* existing medication therapy at hospitalization
* admission to one of the project wards via emergency department (non elective)

Exclusion Criteria:

- patients included in the study previously
Multiple Dose Study of TRx0037

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of TRx0037 after multiple doses in elderly volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Male and female 55 and over
* No clinically important abnormal physical finding
* No clinically significant lab results
* Normal ECG
* Normal BP and HR
* BMI between 19 and 32
* Weight 50 to 100 kg
* Able to communicate
* Provide written informed consent
* Non smokers
* Males to use contraception
* Females to be surgically sterile or post menopausal

Exclusion Criteria:

* Administration of any IMP other than study drug within 12 weeks before entry
* Use of any prescribed meds, St John's wort, over the counter meds as described in the protocol
* Surgical or medical condition that might interfere with IMP
* History of drug or alcohol abuse
* Clinically significant allergy requiring treatment
* Loss of greater than 400ml of blood within 12 weeks.
* Serious adverse reaction or hypersensitivity to any drug
* Presence of Hep B, Hep c or HIV-1 or HIV-2 at screening
* Presence of G6PD at screening
* History of methaemoglobinaemia
* Partner who is pregnant of lactating
* Positive Pregnancy test
Effects of Different Exercise Training Modalities in Alpha-1 Antitrypsin Deficiency Patients

Pulmonary rehabilitation (PR) including exercise training is highly effective by improving health-related quality of life, exercise capacity and symptoms in patients with chronic obstructive pulmonary disease (COPD). Therefore, PR is a main component in the management of COPD. In a former study patients with Alpha-1 Antitrypsin deficiency (A1ATD)-related COPD (genotype PiZZ) have been found to show smaller improvements in exercise capacity after a 3-week inpatient PR program compared to COPD patients without A1ATD (genotype PiMM)\[1\]. These between-group differences were mirrored by missing adaptations of the fatigue-resistant skeletal muscle fibre type I in A1ATD patients. This was in contrast to COPD patients without A1ATD who increased the proportion of this fibre type after PR. Myofibre type I is crucial because it enables patients for physical endurance activities (walking, cycling etc.) during their daily life.

The aim of this study is to compare the effects of an exercise Training program with high vs. moderate Training intensity in order to find a Training modality which improves Training effects in A1ATD patients.


Eligibility Criteria:
Inclusion Criteria:

* COPD patients with A1ATD (genotype PiZZ)
* COPD patients without A1ATD (genotype PiMM)
* Global initiative for chronic obstructive lung disease (GOLD) stage III-IV
* Medical Treatment according to recent A1ATD guidelines

Exclusion Criteria:

* General exclusion criteria for physical Training such as acute coronary Syndrome, acute myo- or pericarditis, acute lung embolism, acute heart failure, orthopedic comorbidities which prevent patients from participating in exercise Training program.
* No written informed consent
* Non-compliance
A Research Study to Look at How Faster Aspart Works in Chinese People With Type 1 Diabetes or Type 2 Diabetes

This study looks at how faster aspart reaches and stays in the blood after injection in Chinese people with type 1 diabetes or type 2 diabetes, compared to the reference product called NovoRapid®. Participants will get both faster aspart and NovoRapid®. The order in which Participants get them is decided by chance. Participants will get each study medicine once during the study meaning that they will get a total of 2 injections with study medicines. The medicine will be injected under the skin of the lower abdomen. The study will last for about 19-72 days. Participants will have 5 clinic visits with the study doctor (including the one in which participants give their consent). Participants will need to stay overnight for 2 of the 5 clinic visits. Participants will have blood samples taken during some of the clinic visits. During the visits where participants get the study medicines, samples of their blood will be taken several times for up to 12 hours after getting the study medicine.


Eligibility Criteria:
Inclusion criteria:

For a subject with type 1 diabetes mellitus:

* Male or female Chinese subjects aged 18-64 years (both inclusive) at the time of signing informed consent.
* Type 1 diabetes mellitus (as diagnosed clinically) greater than or equal to 12 months prior to the day of screening.
* Treated with multiple daily insulin injections or premix insulin greater than or equal to 12 months prior to the day of screening or treated with continuous subcutaneous insulin infusion (CSII) greater than or equal to 3 months prior to the day of screening.
* Glycosylated haemoglobin (HbA1c) less than or equal to 9.0 percent (75 mmol/mol) by central laboratory analysis.

For a subject with type 2 diabetes mellitus:

* Male or female Chinese subjects aged 18-75 years (both inclusive) at the time of signing informed consent.
* Type 2 diabetes mellitus (as diagnosed clinically) greater than or equal to 12 months prior to the day of screening.
* Treated with multiple daily insulin injections or premix insulin greater than or equal to 6 months prior to the day of screening or treated with continuous subcutaneous insulin infusion (CSII) greater than or equal to 3 months prior to the day of screening.
* Glycosylated haemoglobin less than or equal to 9.5 percent (80 mmol/mol) by central laboratory analysis.

Exclusion criteria:

For a subject with type 1 diabetes mellitus or type 2 diabetes mellitus:

* Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
* Surgery or trauma with significant blood loss (more than 400 mL) within the last 3 months prior to screening.
* Not able or willing to refrain from smoking and use of nicotine substitute products during the in-patient period.
Inspiratory Muscle Strength Training for Sleep-related Breathing Disorders

The purpose of the current study is to investigate the effects of a novel breathing training, called inspiratory muscle strength training (IMST), on sleep patterns, breathing and blood pressure for patients diagnosed with mild, moderate and severe sleep apnea.

Aims of the study:

1. To determine the influence of IMST on resting blood pressure and baroreceptor sensitivity.
2. To determine the effect of IMST on sympathetic nervous system by measuring plasma cathecholamines and nerve recording (MSNA).

Population:

30 subjects aged 30-75 years, who have previously been diagnosed with obstructive sleep apnea, as defined by the National Institutes of Health (National Heart Lung, and Blood Institute) will be included in this study.

Study Protocol:

* Pre-training assessment and overnight sleep study
* 5-10 minutes each day breathing training (IMST) at home using a hand-held device for 6 weeks
* Once weekly laboratory visit
* Post-training assessment and overnight sleep study

Pre- and post-training assessment include blood pressure measurement, body weight, neck circumference, cardiorespiratory monitoring, nerve recording, blood draw and sleep surveys.

Eligibility Criteria:
Inclusion Criteria:

* Age 30-75 years
* Diagnosed with Obstructive Sleep Apnea with Apnea Hypopnea Index (AHI) \> 15
* Neck circumference \> 16 cm

Exclusion Criteria:

* Body mass index (BMI) \> 40kg/m2
* Implanted pacemaker
* On anticoagulant medication
* On hypnotic medication
* On immunosuppressive medication
* Acute or recent (3 months prior to study) infection
* History of hypothyroidism
* History of stroke or neuromuscular disease
* Moderate to severe heart failure
* Severe ischemic heart disease
* Severe obstructive and restrictive lung disease
* Cor pulmonale
* Cognitive disorders
* Obstructive nasal disease or history of spontaneous pneumothorax or rib fracture
* History of neurological, respiratory, head /neck, or thoracic surgery
Effectiveness of Multiple Robotic Gait-Devices for Improving Walking Ability in Subacute Stroke Patients

The purpose of this study is to know the effectiveness of different robotic devices for gait rehabilitation in stroke patients

Subjects will attend the Neuron rehabilitation clinic on their own to begin a rehabilitation program. After being recruited for the study and signing informed consent the patient will be assessed with the Timed Up and Go Test and 10 Meter Walking Test, and it will be realized a spatio temporal variables analysis with baiobit system and a superficial Electomiografic activity analysis during gait with Noraxon system.

Once the assessment is completed, the participant will receive the treatment assigned at his rehabilitation clinic. The patient will receive 30 minutes of robotic treatment with Lexi, Lokomat, C-Mill or the body-weight support treadmill and 15 minutes of overground walking training between 70-85% of HR max.

Once the treatment period is over, after 25 sessions, the assessment will be carried out again, recording the initial tests in the same order by the same assessors.

Eligibility Criteria:
Inclusion Criteria:

* Having suffered an ischaemic or haemorrhagic stroke with less than 6 months of evolution at the start of the study
* Presenting gait deficits compatible with a level between 2 and 3 of the functional category of gait (FAC)
* More than 20 seconds in the Time Up and Go test
* Less than 3 points on the Reisberg Global Deterioration Scale (GDS-R).

Exclusion Criteria:

* Presenting any type of specific contraindication to use the robotic device to be used with respect to their group. Thus, those patients who present a limitation in the range of movement in the hip of more than 0º of extension and 40º of flexion, in the knee of less than 30º of flexion and in the ankle of less than 0º of dorsal flexion will not be able to participate in the study.
* Lower limb spasticity greater than 3 on the modified Asworth scale
* Unable to maintain an assisted standing position for more than 5 minutes
* Unable to understand simple commands
Non Invasive Detection of IDH1/2 Mutation in Gliomas

This trial develops a non invasive diagnostic approach of IDH1 mutated gliomas combining mutation detection from free plasmatic DNA, D-2HG dosage in urine samples, and D-2HG detection by Brain Spectro MRI.

In group 1 (25 patients), patients with presumed grade II-III gliomas candidate to surgery will undergo spectro MRI, plasma, urine dosages. Results will then be confronted to tumor mutational status and D-2HG.

In group 2 (15 patients), patients with known IDH1 mutation will undergo spectro MRI, plasma, urine dosages overtime in order to correlate results with the response to treatment.

The aim of this trial is to develop and validate a non invasive diagnostic approach of IDH1 mutated gliomas. It will evaluate the specificity and sensitivity of D-2HG detection by Brain Spectro MRI. This approach will be coupled with mutation detection from free plasmatic DNA and D-2HG dosage in urine samples.

The primary end-point is the quantification of D-2HG by spectro-MRI, and the correlation with the dosage of D-2HG in the tumor fragment, and the mutational status (group 1: 25 patients).

The secondary endpoints include:

1. longitudinal analysis Spectro-MRI overtime (12 months) correlation with radiological evolution and the response to treatment (group 2: 15 patients)
2. Differentiation of tumor recurrence from radiation induced changes
3. Confrontation of Spectro-MRI, D-2HG dosages and IDH mutation detection from plasma DNA, and elaboration of a combined score of prediction

Eligibility Criteria:
Inclusion criteria

1. Affiliation to a social security system
2. Patient≥ 18 years old
3. Written informed consent
4. One of the two situations:

   * presumed grade II-III glioma candidate to surgery (group 1)
   * IDH1/IDH2 mutated grade II-III gliomas, candidate to chemotherapy or radiotherapy treatment, or simple follow-up (group 2)
5. Evaluable tumoral mass min diameter \>2 cm (FLAIR)
6. PKPS \> 60

Exclusion criteria

1. Contra-indication to MRI
2. Patient unable to give an written Informed Consent
3. Patient under guardianship or deprived of freedom
4. For group 2: patient already included in group 1
The Effect of DBcare, a Food Supplement on Diabetes Control

DBcare is a herbal food supplement that has been used over the years in India as a "traditional"anti-diabetic formula.DBcare was not tested controlled trials in humans, yet.We intend to test the ability of DBCare to improve blood sugar level control in patients with uncontrolled diabetes.

Study design: prospective, randomized, single-blind, placebo-controlled trial

Inclusion criteria:

Men and women (older than 18 years old) with type 2 diabetes and inadequate glycemic control, defined by HbA1C 8% ³ £10%.

Previous medications include any oral hypoglycemic agents, as monotherapy or in combination.

Concurrent lipid-lowering, anti-hypertensive and other medications are allowed

Exclusion criteria (before the study):

Type 1 diabetes mellitus Pregnant or lactating women Insulin treatment 3 months prior to study entry Creatinine \>2 mg/dL Abnormal liver function tests GOT\>X2 or GPT\>X2 the upper normal limit Unstable anginal syndrome Congestive heart failure (NYHA class I-IV) Inability to follow study instructions including low compliance

Exclusion criteria (during the study):

Severe hypoglycemia (less than 50 mg%) or any hypoglycemic event requiring intravenous glucose infusion

Number of patients: 30 patients (drug) 30 patients (placebo)

Design:

Four out-patient visits, at enrollment and every month thereafter At enrollment (visit 1) physical examination will be performed and a full set of blood tests will be withdrawn At 1 week (visit 2) adjustment of hypoglycemic medications will be done and full chemistry and blood count will be taken At 6 weeks (visit 3) adjustment of hypoglycemic medications will be done and full chemistry and blood count will be taken At 12 weeks (visit 4), the end of the study, physical examination will be performed and a full set of blood tests will be withdrawn On the 2nd 3rd and 4th visits pill-count will be performed Glucose monitoring: patients will be asked to monitor fasting glucose levels at home, in the morning, on a daily basis

Drugs: identical drug containing/ placebo capsules Drugs for a month will be given in each monthly visit

Dose: 2 tablets three times daily

Eligibility Criteria:
Inclusion Criteria:

* Adults \>18y
* With type 2 diabetes mellitus and inadequate glycemic control
* HBA1C \>8 \<10
* Previous medications include oral hypoglycemic medications,as monotherapy or in combination

Exclusion Criteria:

* Type 1 diabetes mellitus
* Pregnant or lactating women
* Insulin treatment 3 months prior to study entry
* Creatinine \>2
* Abnormal liver function test GOT\>2 or GPT\>2 the upper limit of norm
* Unstable anginal syndrome
* Congestive heart failure NYHA 1-4
* Inability to follow study instructions
Treatment of Bronchial Asthma With Borage and Echium Seed Oils

The aim of this trial is to determine the efficacy of a combination of two botanicals oils, borage seed oil and echium seed oil, as a potential treatment for bronchial asthma.

Leukotrienes are important in the pathogenesis of inflammation, and leukotriene modifying drugs are now an established treatment for bronchial asthma and rhinitis. Drugs that inhibit the biosynthesis of leukotrienes are likely to be more effective than the currently available drugs that antagonize a single leukotriene receptor. Dietary supplementation with gamma linolenic acid (GLA) in borage seed oil provides effective inhibition of leukotriene generation but also increases circulating free arachidonic acid (AA), which has pro-inflammatory potential. The n-3 fatty acid, eicosapentaenoic acid (EPA), prevented the conversion of GLA to AA. However, EPA is extracted from fish oil, is not well-tolerated due to its taste, and at higher doses appeared to blunt the inhibition of leukotriene biosynthesis by GLA. Stearidonic acid (SDA) is a precursor of EPA that is extracted from Echium plantagineum; it is converted to EPA in humans and it does not have the organoleptic properties of EPA.

We recently completed a dose-ranging study in which we determined the dose of SDA that is sufficient to inhibit the rise in circulating levels of arachidonic acid while maintaining effective inhibition of leukotriene generation.

The goal of the present study is to test the efficacy of dietary supplementation with GLA and SDA (provided in borage seed oil and echium seed oil) in treating bronchial asthma.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bronchial asthma
* Male or female 18 years to 65 years of age
* FEV1 50 to 90% of predicted, or personal best.
* Improvement of \>=12% FEV1 with bronchodilator

Exclusion Criteria:

* Pregnant or nursing
* Smoking history of \> 10 pack years or active smoking within the past year.
* Due to possible effects on leukotriene biosynthesis, use of the following asthma treatments within the preceding month will be exclusion criteria:

  * leukotriene modifying drugs,
  * theophylline
  * oral steroids.
  * dietary supplements with fatty acids or other products that may interfere with leukotriene generation.
* Treatment within the previous three months with omalizumab (monoclonal antibody directed against IgE)
* Subjects will not be permitted to take non-steroidal anti-inflammatory drugs in the week prior to any measurements of ex vivo leukotriene generation because of their effects on leukotriene biosynthesis via inhibition of prostaglandin generation.
* A history of aspirin-sensitive asthma
* Significant abnormalities in CBC, differential white cell count, renal function, and liver function, or urinalysis.
* Any serious co-morbid medical condition.
Influence of Telemonitoring on the Management of LVAD-patients

The current study aims to investigate whether telemedical monitoring in patients with terminal heart failure and an implanted left ventricular assist device (LVAD) has an influence on LVAD-associated complications, hospitalization rates and quality of life. This is a prospective observational study. Patients with terminal heart failure and an implanted LVAD, where the indication for telemonitoring has already been stated by the attending physician are included in the study. Written informed consent is obtained from all patients. The telemedical monitoring is carried out by the West German Center for Applied Telemedicine (WZAT) and includes a standardized telephone interview every 3 days. In addition, all patients are equipped with an INR measuring device, a body scale and a clinical thermometer by WZAT. The data is documented in an electronic case file (medPower®). In the event of abnormalities, the West German Heart and Vascular Center (WHGZ) is contacted, and all necessary measures are initiated.


Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years
* Indication for telemedicine
* Permanently implanted left ventricular assist device (VAD)

Exclusion Criteria:

* no possibility of telephone contact
* patient does not speak german
* incompliance
* rejection or inability to give consent
Foot Disorders in X-linked Hypophosphatemia

This study aimed to characterize foot pathologies using X-rays and clinical examination and assess related outcome scores in adolescents and adults with X-linked Hypophophatemia

A single center, cross-sectional analysis of adolescent and adult patients with XLH with and without previous surgical intervention was performed at the Orthopaedic Hospital Speising, Vienna, Austria. Clinical examination, quality of life questionnaires and radiographic data of foot x-rays in standing position were collected. Radiographic evaluation was performed to analyze foot deformity as well as signs of osteoarthritis at the foot.

Eligibility Criteria:
Inclusion Criteria: - Patients with confirmed XLH, ≥ 16 years were invited to participate in this study

Exclusion Criteria:

* Exclusion criteria were other forms of hypophosphatemia, pregnancy and recent lower limb surgery within 3 months.
Phase 2 Study of KH001 in Long-term Relief from Dentin Hypersensitivity

The purpose of this study is to evaluate the efficacy and safety of KH001 in subjects with dentin hypersensitivity.

The study will consist of a screening period, a treatment period, and a follow-up period. The total duration of the study for each subject will be approximately 8 to 12 weeks. All subjects will be randomly assigned in a 1:1:1 ratio, with Group A, Group B and Group C.

Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years old by the time of the screening visit
* Is in good general health as determined by the investigator
* Has at least 2 non-adjacent teeth and is diagnosed with hypersensitive

Exclusion Criteria:

* Is allergic to the active drug substance or other excipients used in the investigational product
* Has any history of alcohol or drug abuse
* Has received any treatment related to dentin hypersensitivity within 8 weeks prior to the screening visit
* Is jedged by the investigator as ineligible for participation for other reasons