cyrilzakka/clinical-trials huggingface dataset:
Milk Consumption on Digestive Comfort.

Lactose, naturally present in milk, can cause digestive discomfort. Delactosed milk is currently the only one alternative to cow's milk for intolerant people. As some of them do not digest milk, it was completely remove from their diet. However, are they really intolerant to lactose or intolerant to milk (or to another of its compounds)? Do β-caseins play a role in this intolerance? β-caseins are proteins naturally present in milk. Two types of β-caseins were identified: A1 and A2. These types differ according to the genetic profile of the cow and depend on the breed. The rare clinical studies interested in this topic suggest that:

1. consumption of milk A1 versus consumption of milk A2 can lead to: softer stools, delayed transit, as well as pro-inflammatory effects in some individuals,
2. consumption of A2 milk significantly reduces gastrointestinal symptoms and improves digestive comfort in lactose intolerant people.

Thus, it would be interesting to be able to assess the effect of a consumption of A2A2 milk type compared to A1A2 milk type, both on the parameters of digestive comfort and on inflammatory parameters.

The study will be carried out on healthy volunteers, aged 18 to 65 and self-declared sensitive, even intolerant to the consumption of milk.

The main objective of the study is to assess the impact of milk β-caseins (A2A2 vs A1A2) on the digestive comfort felt during the consumption of milk in subjects declaring that they do not tolerate milk.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman;
* 18 to 65 years old;
* Declaring to have sensitivity or intolerance when consuming cow's milk;
* Agreeing to follow the constraints generated by the study;
* Having signed the informed consent form;
* Social insured.

Exclusion Criteria:

* Subject with an allergy to cow's milk proteins;
* Subject suffering from a severe eating disorder (anorexia, bulimia, binge eating);
* Subject with chronic pathology interfering with the parameters studied during this study (inflammatory intestinal disease, celiac disease);
* Subject suffering from acute intestinal infection at the time of inclusion (gastroenteritis, etc.);
* Subject with immunodeficiency or any other serious pathology (cancer, hemopathy);
* Pregnant or planning to be pregnant during the study period;
* Subject participating in another clinical study or in period of exclusion from another study;
* Subject deprived of liberty;
* Subject under judicial protection measure;
* Whose main investigator or a qualified co-investigator judges that the state of health or the concomitant treatments are not compatible with the good progress of the clinical study.
Biportal Endoscopy Spine Surgery (BESS )Versus Unilateral Laminotomy Bilateral Decompression (ULBD ): RCT, Non-inferiority Trial

This study is to compare the clinical outcome between the biportal endoscopic decompression and the unilateral approach bilateral decompression in spinal stenosis


Eligibility Criteria:
Inclusion Criteria:

* patients aged between 30 and 80
* patients who has radiating pain (VAS \>=40) on lower extremities with spinal stenosis over Gr B
* patients who required one-level decompression between L1 and S1
* those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form

Exclusion Criteria:

* Revision surgery
* Over spondylolisthesis Gr II
* Degenerative lumbar scoliosis (Cobb angle \>20)
* herniated disc
* patients with a history of other spinal diseases (compression fracture, spondylitis, tumor)
* women with positive pregnancy tests before the trial or who planned to become pregnant within the following 3 years
* patients with a history of malignant tumor or malignant diseases (but the cases of cured disease with no relapse for the past 5 years were included in the present study)
* patients with mental retardation or whose parents or legal guardians were older or had mental disabilities
* other patients viewed as inappropriate by the staff
InvEstigating oeStrogen Signalling and the Effect upoN the exTracelluar Matrix In pAtients With Obstructive Lung Disease

This study aims to understand the role of oestrogen in patients with asthma and Chronic Obstructive Pulmonary Disorder (COPD). Therefore, what is the effect of oestrogen in these participants compared to controls (those without disease). The study hypothesises that oestrogen loss in patients with asthma and COPD causes accelerated lung function decline and changes to lung structure. It will investigate if this is mediated by inflammation, immune host response or elastin and collagen changes. It is an observational prospective cohort study aiming to recruit healthy controls, and people with asthma or COPD), and/or the menopause.

The investigators are investigating the effect of oestrogen and oestrogen loss on the lungs. This is important to because lung diseases are a growing problem globally. In people suffering from Asthma and chronic obstructive pulmonary disease (COPD), women are more likely to die from lung disease than men. The researchers believe this global difference is due to sex hormones. Women have more oestrogen than men. Other studies have shown that oestrogen affects the lungs through the immune system. The researchers want to know the effect that oestrogen has on the lungs in people suffering from Asthma and COPD by comparing this to people with no lung disease. The researchers are also particularly interested in what happens at the point where women lose oestrogen naturally, which is the menopause. They want to understand the effect of oestrogen in younger women and compare this to women who have experienced the menopause. This is an observational study. Therefore, the participants will have a baseline visit and another subsequent visit (or multiple visits which are optional) and the researchers will compare the changes in their oestrogen levels, lung function and immune system response. To understand the differences mentioned above in the body we require samples and questionnaires to be filled out at face-to-face visits. All participants will be given the opportunity to opt into different streams of visits which vary between 12 months and 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged \&gt; 18 years.
2. For female participants: pre-menopausal, peri-menopausal and post-menopausal women can all be included.
3. Participants willing and able to give informed consent for participation in the study.
4. Healthy controls \&lt;10 pack year history (participants without Asthma or COPD).

Exclusion Criteria:

1. Known or suspected current pulmonary tuberculosis, HIV (human immunodeficiency virus), Hepatitis B Virus, Hepatitis C Virus.
2. Alcohol or recreational drug abuse, is defined as when the use is harmful as per NHS definition.
3. History of psychiatric, medical, or surgical disorders.
4. Pregnant
5. Unable to provide written informed consent
6. History of advanced medical conditions with an expected prognosis of \&lt; 3 years.
7. Patients with a history of active cancer.
8. Patients on long term oxygen (ambulatory oxygen).
Phase 2 Study of KHK7580

This randomized, placebo-controlled, double-blind (included open arm of KRN1493 (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and safety in cohorts comprising KHK7580, its placebo and KRN1493 (cinacalcet) orally administered for three weeks for secondary hyperparathyroidism patients receiving hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have voluntarily consented to participate in this study
* Subjects with stable chronic renal disease receiving hemodialysis 3 times weekly for at least 12 weeks before screening
* Subjects with an intact Parathyroid hormone of \>= 240 pg/mL at screening

Exclusion Criteria:

* Subjects with primary hyperparathyroidism
* Subjects who have received cinacalcet hydrochloride within 2 weeks before screening
* Subjects whose dose or dosing regimen of an active vitamin D drug or its derivative, phosphate binders, or calcium preparation has been changed or started within 2 weeks before screening.
* Subjects who have underwent parathyroidectomy and/or parathyroid intervention within 24 weeks before screening.
* Subjects with uncontrolled hypertension and/or diabetes
* Subjects with severe heart disease.
* Subjects with severe hepatic dysfunction.
* Subjects who have received any other investigational drug within 12 weeks before screening
* Other subjects unfit for participation in this study in the judgment of the investigator or sub investigator.
Lung Function Changes of Induced Asthma Children Treated With Inhaled MgSO4

As a non-selective bronchodilator, magnesium sulfate (MgSO4) is effective when administered intravenously in the treatment of the patients with acute severe asthma not responding to conventional therapy (oxygen, nebulized salbutamol, and corticosteroids), which can resulted in earlier improvement in clinical signs and symptoms of asthma and PEF. However, the use of intravenous MgSO4 administered is not common in clinical practice, because it's prone to have adverse effects and side effects such as nausea, vomiting, facial flushing, hypotension, decreased tendon reflexes and so on with this treatment. The aerosolised route offers the advantage of lower dosage, a shorter time of drug being delivered to the airway smooth muscle and lower incidence of side effects when compared to the intravenous route. At present, there are only a few studies about the effects of nebulized MgSO4 in the treatment of acute asthma in children, and the conclusions are controversial.


Eligibility Criteria:
Inclusion Criteria:

* known cases of controlled bronchial asthma
* ≧4 years of age
* the result was positive after acetylcholine provocation test in follow-up visit

Exclusion Criteria:

* had received corticosteroids (inhaled or systemic) or β2-agonists or theophyllines before the clinic day
* had fever (axillary temperature\>38.5℃)
* history of chronic disease like bronchopulmonary dysplasia or cystic fibrosis
* history of renal insufficiency and known allergy to acetylcholine, albuterol or magnesium
The Evaluation of Infant Formulas Fed to Infants With Common Feeding Problems

This clinical trial will determine if the formula given to infants experiencing fussiness, crying, cramping, gas, and/or diarrhea, is accepted and well tolerated and helps to resolve symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Subject is between 2 and 12 weeks of age
* Subject has currently been receiving a milk-based lactose-containing formula for at least 5 days as the sole item of diet
* Subject has never switched to any lactose free formula
* The parent/guardian who will fill out the quality of life questionnaire is female and at least 18 years of age
* The parent/guardian has reported an unsolicited history of feeding problems including fussiness/crying/cramping, gas, or diarrhea
* Signed Informed Consent

Exclusion Criteria:

* Subject is in daycare for more than 4 hours per day (20 hours per week)
* Subject has serious perinatal complications, underlying disease or congenital malformations that impair normal formula feeding
* The parent/guardian who will fill out the quality of life questionnaire has chronic illness, e.g. diabetes, inflammatory bowel disease or other illness requiring daily medication or treatment
* Subject has acute infectious diarrhea or any other intercurrent illness
Assessment of Stent Malapposition and Neointimal Coverage on Optical coHerence Tomography at Post-procedure and 3 Months After Platinum Chromium Alloy Of the Element™ Stent Implantation

The purpose of this study is to compare the degree of stent malapposition on an immediate optical coherence tomography (OCT) after nominal stent pressure and at a final post-procedure OCT (ANCHOR-I) and the neointimal coverage on 3-months OCT following the intervention with the randomly assigned two drug-eluting stents (DES), PromusTMElementTM stents versus Xience PRIME® stents.


Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 20 years old
* Significant coronary de novo lesion (\> 70% by quantitative angiographic analysis) treated by single DES in each vessel.
* Patients with stable angina who are considered for coronary revascularization with stent implantation.
* Reference vessel diameter of 2.5 to 3.5 mm by operator assessment

Exclusion Criteria:

* Complex lesion morphologies such as aorto-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, and restenosis
* Reference vessel diameter \< 2.5 mm or \> 4.0mm and lesion length \> 28 mm
* Heavy calcified lesions (definite calcified lesions on angiogram)
* Lesions requiring more than 2 DES in each vessel
* Acute coronary syndrome
* Contraindication to anti-platelet agents
* Treated with any DES within 3 months at other vessel
* Creatinine level ≥ 2.0 mg/dL or ESRD
* Severe hepatic dysfunction (3 times normal reference values)
* Pregnant women or women with potential childbearing
* Life expectancy 1 year
HEalth Promotion Intervention in MEntal Health Care

Overweight and obesity have become a serious global public health problem and the prevalence of these conditions is even higher among persons with mental disorders, compared with the general population. Overweight and obesity are partially associated with sedentary lifestyles and unhealthy eating habits.

The aim of the study is to examine the effectiveness and cost-effectiveness of a health promotion intervention targeting physical activity and eating habits in persons with mental disorders.

The study hypothesis is that between baseline and the end of the intervention, and after a 6-month follow up period, significant differences in the primary and secondary outcomes between the intervention and control group will be identified. The investigators also hypothesize that the health promotion intervention will be cost-effective.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* living in sheltered housing
* diagnosed according to the Diagnostic and Statistical Manual of mental disorders (DSM-IV manual)
Comparison Between Laying Open and Sinus Excision of Pilonidal Sinus - a Randomized Study

A pilonidal sinus is a cyst or abscess near or on the natal cleft of the buttocks that often contains hair and skin debris. The condition is common and requires surgery to be cured. Several surgical procedures are described in literature. The most common surgical procedure in Sweden is excision of the sinus followed by suturing the subcutaneous tissue and skin. This method, however, has some problems regarding healing and recidives. Therefore this study is comparing the standard excision procedure to another surgical procedure, laying open. Healing frequency is the main variable, but postoperative pain, sick leave time and patient satisfaction is also measured.


Eligibility Criteria:
Inclusion Criteria:

* Pilonidal sinus eligible for surgery
* Age \> 18 years
* Swedish speaking

Exclusion Criteria:

* Active signs of infection prohibiting primary sewing of the wound
Safety and Efficacy of the Vascular Closure Device (Tonbridge) in Hemostasis Treatment of Femoral Artery Puncture

The purpose of this study is to verify the safety and efficacy of the Vascular Closure Device (Tonbridge) in hemostasis treatment for femoral artery puncture.

This is a prospective, multicenter, randomized control, non-inferiority clinical trial carried out in 7 centers throughout China. 228 subjects with hemostasis of femoral artery puncture will be treated with the Vascular Closure Device (Tonbridge) or the EXOSEAL Vascular Closure Device (Codis Corporation). The primary objective of this study is to evaluate the safety and effectiveness of the vascular closure device in hemostasis treatment for femoral artery puncture.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80, male or non-pregnant female;
* Subjects undergoing unilateral femoral artery retrograde puncture for angiography or interventional procedure;
* Using guide sheath ≥5F to ≤8F, and length ≤12cm in angiography or interventional procedure;
* Subjects or their legal guardians voluntarily participate in this study, can complete follow-ups, and sign the informed consent form.

Exclusion Criteria:

* Ipsilateral common femoral artery occlusion or lumen diameter \< 5mm;
* Inability to walk;
* Allergy to contrast media;
* Allergy to PGA or PEG; subjects with a history of common femoral artery surgery, percutaneous transluminal angioplasty (PTA), stent implantation, or vascular graft;
* Subjects with bleeding tendency, such as thrombocytopenia (platelet count \<100×109/L), hemophilia, von willebrand diseases, pre-procedure INR \>1.5, etc.;
* Subjects have taken anticoagulants for a long term before the procedure and have blood coagulation disorders;
* BMI \>40kg/m\^2;
* Subjects receive thrombolytic therapy (such as streptokinase, urokinase, t-PA) within≤24 hours before vascular closure;
* Local infections or skin infections of the investigational limb;
* Subjects with target femoral artery dissection or aneurysm within 30 days before intervention procedure;
* Subjects with puncture site have been punctured through the posterior wall of the femoral artery, or have been punctured several times (≥3 times), or have bleeding or hematoma on the femoral artery puncture site during the procedure;
* Subjects with clinically significant peripheral vascular diseases (such as severe calcification, arteritis, stenosis, etc) near the puncture site;
* Women who are pregnant or breastfeeding, OR men or women who plan to have a child in the next 6 months;
* Subjects who are enrolled in other clinical trials and don't complete;
* Subjects are considered not suitable for enrollment by the investigators.
IL Ancillary Study of the Therapeutic Hypothermia After Nonshockable Cardiac Arrest Trial.

Cardiac arrest is at present a major cause of mortality as well as a cause of disability for the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for 250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality of life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to the initial cardiac rhythm present during the initiation of resuscitation. Recent progress in the improvement of mortality and neurological outcome has been achieved over the last decade thanks to the systematic implementation of a period of targeted temperature control between 32 and 34 ° C in patients who benefited from the realization of at least one electrical external shock.

There are theoretical and clinical arguments to think that achieving the same way a period of targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest with a non- shockable rhythm on arrival can also benefit from this procedure. However other arguments are against this hypothesis including an increase in the risk of infection , worsening of the patient's hemodynamic status with no benefit to him. To answer this question, we conduce a randomized multicenter study testing the potential improvement of neurological outcome through this procedure targeted temperature control between 32.5 and 33.5 ° C in these patients.

IL Ancillary Study of HYPERION Trial will determine impact on inflammatory biomarkers of two temperature target for targeted temperature management (33°C or 37°C) after cardiac arrest in non-shockable rhythm.


Eligibility Criteria:
Inclusion Criteria:

* Cardiac arrest in nonshockable rhythm and
* Glasgow Coma Scale score ≤8. In patients receiving sedative therapy at ICU admission, the Glasgow Coma Scale score assessed by the emergency physician just before sedative therapy initiation is used.
* Patient must be randomized in a center which participate in the ancillary study.

Exclusion Criteria:

* No-flow time \>10 min (time from collapse to initiation of external cardiac massage);
* Low-flow time \>60 min (time from initiation of external cardiac massage to return of spontaneous circulation).
* Major hemodynamic instability (defined as a continuous epinephrine or norepinephrine infusion at a flow rate \>1 μg/Kg/min)
* Time from cardiac arrest to study inclusion \>300 min
* Moribund patient
* Child C cirrhosis of the liver
* Age \<18 years
* Pregnant or breastfeeding woman
* Correctional facility inmate
* Previous inclusion in another randomized clinical trial on cardiac arrest with day-90 neurological outcome as the primary endpoint
* Patient without health insurance
* Decision by the patient or next of kin to refuse the study
Improved Diagnosis of Ovarian Cancer by Use of Circulating Tumor DNA as a Biomarker

This project investigates circulating tumor DNA (ctDNA) in patients with suspected ovarian malignancy.

We hypothesize that measurement of ctDNA in women with suspected ovarian cancer can improve the diagnostic efficiency for preoperative differentiation between benign and malignant masses.

Specifically, we hope to determine the diagnostic efficiency of ctDNA alone and ctDNA in combination with imaging modalities (ultrasonography, MRI, PET-CT) and CA 125 for preoperative differentiation between benign and malignant adnexal masses. Based on this, we hope to develop an improved diagnostic algorithm.

The mutational profile and relation to tumour type, stage, treatment response and prognosis will be explored.

Analyses of blood and tissue samples will be used to examine the disease development and biology.

Blood samples, tumour tissue and data on imaging modalities as well as CA 125 will be collected prospectively in consecutive women referred to Aarhus University Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Suspected ovarian neoplasm
* Informed consent

Exclusion Criteria:

* Inability to give informed consent
* Previous ovarian cancer diagnosis
HeartStart HS1 Defibrillator* Event Registry

A Prospective study on the performance and safety of the HeartStart OnSite (Model M5066A) \& HeartStart Home (Model M5068A) Defibrillator device data.

The objective of this PMCF (Post Market Clinical Follow-up) prospective collection of post-event data registry is to confirm the safety and performance as expressed in the energy delivery by the HeartStart HS1 Defibrillator (HeartStart OnSite and Home models in North America) in the population for the device's intended use in reference to its commercial labeling, and in relationship to the type of pads attached to the device.

Eligibility Criteria:
Inclusion Criteria:

* Have been suspected of a circulatory arrest for any cause.
* Have had HeartStart HS1 Defibrillator with electrodes:

Adult SMART Pads Cartridge \[REF: M5071A\], Infant/Child SMART Pads Cartridge (REF:M5072A) applied to their body and powered up with HS1 battery (Model M5070A), regardless of whether a defibrillation shock was delivered

Exclusion Criteria:

* Subjects will be excluded if any of the following are present:
* AED or pad use other than the HeartStart HS1 Defibrillator with above referenced Philips electrode pads. Note: Use of a device other than the Philips HeartStart HS1 AED does not preclude enrollment if the AED or an Advanced Life Support defibrillator was used after the HeartStart HS1 AED.
* AED used for training purposes.