cyrilzakka/clinical-trials huggingface dataset:
Dose Response AMP Challenge Study With Beclometasone Dipropionate (BDP)/Formoterol Pressurised Metered Dose Inhaler (pMDI)

The aim of this exploratory investigation is to evaluate if the Forced Expiratory Volume in the 1st second (FEV1) measurements, fractional exhaled nitric oxide (FENO) and Provocative Concentration 20 (PC20) after Adenosine Monophosphate (AMP) bronchial challenge evaluated after administration of a fixed combination of a Long-acting Beta-2-agonist (LABA) and an Inhaled Corticosteroid (ICS) at increasing doses may be suitable to demonstrate a dose response.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients 18-50 years of age, who have signed an informed consent form.
2. Clinical evidence of asthma
3. Steroid naïve asthmatic patients
4. FEV1 at Screening Visit is \>70 % of the predicted value and at least 2.0 L.
5. Body Mass Index between 18 and 35.
6. Sensitivity to AMP at Screening Visit.
7. FENO levels \>25 ppb at the Screening Visit

Exclusion Criteria:

1. Having received an investigational product within 2 months of Screening Visit.
2. Inability to comply with study procedures or with study treatment intake.
3. Any significant lung disease which is considered by the investigator to be clinically significant.
4. Patients who suffer from Chronic Obstructive Pulmonary Disease (COPD)
5. Previous or current smokers who have a smoking history greater than 5 pack years.
6. Patients with any uncontrolled disease that might, in the judgment of the investigator, place the patients at undue risk or potentially compromise the results or interpretation of the study.
7. Patients with QTc \>450msec at the Screening Visit.
8. Patients with serum potassium \<3.5 mEq/L or \>6 mEq/L.
9. Intolerance/hypersensitivity or any contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids.
10. Patients who have a history of alcohol or substance abuse that in the opinion of the Investigator may be of clinical significance.
11. Patients who have undergone major surgery in the previous 3 months.
12. Patients who have had an exacerbation of asthma, requiring treatment with oral steroids during the last month prior to Screening Visit.
13. Patients treated with slow-release corticosteroids 2 months prior to Screening Visit.
14. Patients currently treated with anti-IgE Antibodies.
15. Patients who have had a respiratory tract infection within 4-weeks prior to Screening Visit.
16. Females not willing to use effective contraceptive measures such as oral contraceptive or intra-uterine device (IUD).
17. Females who are pregnant, lactating or planning to become pregnant
Delineation of the Role of Glucagon-like Peptide-1 Signalling in Relation to Increased Carbohydrate Content in the Distal Small Intestines

Investigation of GLP-1 signalling in the glucose-lowering effect of increased carbohydrate content in the distal small intestines induced by alpha-glucosidase inhibition during meal ingestion in patients with type 2 diabetes

The primary aim of the study is to investigate whether GLP-1 released as a result of increased carbohydrate content in the distal and L cell-rich part of the small intestine after a meal affects postprandial plasma glucose levels in patients with type 2 diabetes. This will be done by applying an alpha-glucosidase inhibitor (to increase the postprandial carbohydrate content in the distal small intestine) and the specific GLP-1 receptor antagonist exendin(9-39) (to isolate any GLP-1-mediated effects) during meal tests in patients with type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least three months (diagnosed according to the criteria of the World Health Organization (WHO)) treated with metformin monotherapy
* Caucasian ethnicity
* Normal haemoglobin
* Age \>18 years
* BMI \>23 kg/m2 and \<35 kg/m2
* Informed and written consent

Exclusion Criteria:

* Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) \>2 times normal values) or history of hepatobiliary disorder
* Gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery
* Reduced kidney function or nephropathy (estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73 m2 (based on serum creatinine) and/or albuminuria
* Treatment with medicine that cannot be paused for 12 hours
* Intake of antibiotics two months prior to study
* Treatment with glucose-lowering drugs other than metformin
* Hypo- and hyperthyroidism
* Treatment with oral anticoagulants
* Active or recent malignant disease
* Any treatment or condition requiring acute or sub-acute medical or surgical intervention
* Lack of effective birth control in premenopausal women
* Positive pregnancy test on study days in premenopausal women
* Pregnancy
* Women who are breastfeeding
* Any condition considered incompatible with participation by the investigators
* If the subjects receive any antibiotic treatment while included in the study they will be excluded
Effects of Recombinant Human Glutamic Acid Decarboxylase on the Progression of Type 1 Diabetes in New Onset Subjects

The purpose of this study is to determine whether treatment with multiple injections of GAD-Alum will preserve the body's own (endogenous) insulin production in patients who have been recently diagnosed with type 1 diabetes mellitus (T1DM).

Type 1 diabetes (T1D) is an autoimmune disease. This means that the immune system (the part of the body which helps fight infections) mistakenly attacks and destroys the cells that produce insulin (islet cells found in the pancreas called islet cells). As these cells are destroyed, the body's ability to produce insulin decreases. Glutamic acid decarboxylase (GAD) is one of the major autoantigens (a protein that the immune system is reacting to) involved in the autoimmune process underlying T1DM.

GAD-Alum is Recombinant human (rhGAD65) and is used as an antigen-specific immune modulator. Previous studies have shown that it may slow or prevent autoimmune destruction of pancreatic islet cells by introducing "immune tolerance". By administering excess autoantigen, the body may stop its attack on its own cells that produce insulin. If the immune system's attack can be halted in a patient with recent onset T1DM, than residual insulin secretion may be maintained. This may be beneficial in decreasing acute and long-term diabetic complications as well as improving glucose control.

Eligibility Criteria:
Inclusion Criteria:

* Age 3 to 45 years - Insulin dependent type 1-diabetes mellitus diagnosed within the previous 3 months
* Stimulated C-peptide levels greater than or equal to 0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted 3 weeks from diagnosis of diabetes
* Presence of GAD65 antibodies
* At least one month from last immunization
* Willing to comply with intensive diabetes management
* If participant is a woman with reproductive potential, she must be willing to avoid pregnancy and have a negative pregnancy test
* Willing to forgo routine clinical immunizations during the first 100 days after initial study drug administration

Exclusion Criteria:

* Immunodeficiency or clinically significant chronic lymphopenia
* Active infection
* Positive PPD test result
* Pregnant or lactating or anticipating becoming pregnant for 24 months following first injection
* Ongoing use of medications known to influence glucose tolerance
* Require use of systemic immunosuppressant(s)
* Serologic evidence of current or past HIV, Hep B, or Hep C infection
* History of malignancies
* Ongoing use of non-insulin pharmaceuticals to affect glycemic control
* Participation in another clinical trial with a new chemical entity within the past 3 months
* Complicating medical issues or abnormal clinical laboratory results that interfere with study conduct or cause increased risk including neurological, or clinically significant blood count abnormalities (such as lymphopenia, leukopenia, or thrombocytopenia)
* History of epilepsy, head trauma or cerebrovascular accident or clinical
* History of alcohol or drug abuse
RapidTEG MA Validation

During normal physiological conditions hemostasis (the ability of blood to clot) is kept in homeostatic balance by feedback mechanisms. These mechanisms involve an extremely complex series of steps on both sides of the coagulation cascade including cellular components (i.e. clot formation and breakdown). However, should this homeostatic balance be upset, normal hemostasis is affected resulting in pathological clotting (vessel blockage) or bleeding (hemorrhage). In instances that include acquired or congenital abnormalities of the hemostatic system it is clinically important to diagnose, monitor and manage the patient to optimize therapeutic intervention. Moreover, it is important to regulate the hemostasis system in the post-surgical outpatient who receives oral anticoagulant therapy to maintain the homeostatic balance.

The TEG® analyzer, using a small whole blood sample, documents the interaction of platelets with the protein coagulation cascade from the time of placing the blood in the analyzer until initial fibrin formation, clot rate strengthening and fibrin-platelet bonding via GPIIb/IIIa, through eventual clot lysis. It displays both qualitatively and quantitatively the two distinct parts of hemostasis - the part that produces the clot and the part that causes the breakdown of the clot. It shows the balance or degree of imbalance in the patient's hemostasis system, highlights any areas of deficiency or excess, and offers a precise view of the patient's hemostasis condition. If the system is not in balance, one can see where the imbalance lies. If a patient is bleeding, it is crucial to determine the cause of bleeding as soon as possible in order to start the proper treatment.

By utilizing a kaolin/tissue factor activator (RapidTEG™), the TEG® system can measure the interaction and simultaneous contribution of the intrinsic and extrinsic coagulation pathways which initiate and result in clot formation. This RapidTEG™ reagent can deliver results faster than activating with Kaolin alone. This protocol will specifically assess one algorithm called MA. MA is a direct function of the maximum dynamic properties of fibrin and platelet bonding via GPIIb/IIIa that represents the ultimate strength of the fibrin clot. This represents platelet function.

The objective of the study is to demonstrate the substantial equivalence of MA RapidTEG vs. MA Kaolin.


Eligibility Criteria:
Inclusion Criteria:

* Patient age \> 18 years old
* Patient is either a Trauma patient OR is diagnosed with known cardiovascular disease.
* Samples must be tested within the recommended timeline (4-6 minutes for non-citrated and between 15 minutes and 2 hours for citrated)

Exclusion Criteria:

* Patients who have been placed on anticoagulation prophylaxis for other conditions (not CPB/PCI related).
* Patients who have established hemostasis system abnormalities (congenital or other).
* Samples identified as affected by testing errors by lab staff.
Superficial Cryotherapy Versus Microneedling in Alopecia Areata

This study is randomized comparative analytical prospective study that included patients with mild and moderate alopecia areata. Patients was divided into two groups Patients in the first group underwent Superficial cryotherapy using dimethyl ether and propane (DMEP) at -57C (Cryotherapy group). Patients in the second group underwent Microneedling (Microneedling group). A total of six sessions were done at 2 weeks interval. Patients were followed-up for next 3 months to evaluate the persistence of hair regrowth after therapy. Patients were assessed at baseline and during follow up using photography, Dermoscopy, SALT score and regrowth scale.


Eligibility Criteria:
Inclusion Criteria:

* ِAlopecia areata patients

Exclusion Criteria:

* Alopecia totalis and universalis
* ِAge less than four years.
* ِPregnancy or breast-feeding.
* ِActive infection at the site alopecia patch(s).
* ِInflammation ate site of the alopecia patches
* ِIntolerance to cold.
* ِAssociated systemic illness such as thyroid, pernicious anaemia, diabetes mellitus, autoimmune connective tissue diseases.
* ِPrevious treatment for alopecia areata over the last three months.
PRACT to Investigate Controlling Alcohol Related Harms in a Low-Income Setting; Emergency Department BIs in Tanzania

Alcohol use is rapidly increasing in low- and middle-income countries, where it is inexpensive, readily available, poorly regulated, and there are few resources devoted to promoting safe alcohol use. A Brief Intervention based on a motivational interviewing framework has been shown to reduce alcohol use and alcohol-related harms. The investigators have translated and adapted a Brief Intervention for alcohol to the Tanzanian context and Swahili language called "Punguza Pombe Kwa Afya Yako (PPKAY)/ Reduce Alcohol for Your Health." This project will evaluate this intervention in injury patients presenting for care at the Kilimanjaro Christian Medical Center in Moshi, Tanzania. By using innovative adaptive clinical trial methods, the investigators will expedite the development of the most effective way to integrate this intervention into clinical care. By the end of this project, investigators will have identified the most effective brief intervention components and be able to characterize the intervention's effect overall. Additionally, investigators will standardize adaptive trial methods to revolutionize the science of clinical trials for behavioral sciences in low-resource settings.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age)
* present seeking initial care at the KCMC ED for an acute (\<24 hours) injury
* not clinically intoxicated (i.e., have capacity to consent).
* one or more of the following: 1) disclosed alcohol use prior to injury, 2) scored ≥8 on the AUDIT, 3) test positive (\>0.0 g/dL) by alcohol breathalyzer.

Exclusion Criteria:

* do not speak the native Swahili language
* too ill or unable to communicate
* prior enrollment in this study
* decline informed consent.
Diagnosis of Occult Hip Fractures With Ultrasound

occult hip fractures present to the emergency room with a history of trauma,a painful hip and normal X-ray. these patients usually undergo other imaging modalities such as CT scans, MRI, or bone scans.

In this study we check the sensitivity and specificity of a directed ultrasound examination of the hip joint in diagnosing or excluding a hip fracture. We also compare the results of ultrasound examination by the orthopedic surgeon in the emergency room versus the consultant radiologist.

The patients undergo bone scans or CT to make the diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* patients over age of 50 with clinical suspicion of a hip fracture

Exclusion Criteria:

* previous fracture or surgical intervention in the hip
* pregnancy
* flexion contracture of hip
Assessment of in Vivo Skeletal Muscle Viscoelasticity (ARFI Imaging) With Aging and Cancer

Sarcopenia is known to be associated with loss in muscle mass that results from a reduced number of muscle fibres, an atrophy of remaining muscle fibres, and an increased infiltration of non-contractile tissue (collagen, fat). Accentuated by cancer and treatments, sarcopenia impairs muscle function resulting in a higher risk of physical disability and death. The commonly used test for sarcopenia screening consists in a DEXA (Dual energy X-ray absorptiometry) scan. However, this test can't provide structural muscle information. In contrast, the mechanical properties of muscle tissue can be explored using an acoustic radiation force impulse (ARFI). The question remains whether muscle sonoelastography using ARFI imaging could be helpful for sarcopenia screening.

For this, volunteers will be recruited in three groups: ≤ 30 years (Gr A) and ≥ 70years, both without any serious chronic disease, and patients ≥ 70 years presenting curative cares for cancer (Gr C).

The volunteers belonging to the groups A and B will be followed during one day. The patients included in the group C will be followed during 6 months. For this latter group; the first visit (t0) will take place before treatment and the second visit will take place 6 months later (t6months) Volunteers will have clinical examinations (weight, stature, BMI, performance status/ ECOG) and will be evaluated on their nutritional status (MNA-SF, 24h dietary recall) and physical capacities (IPAQ, SPPB, lower limb muscle strength, 6-min walk test, QLQ-C30 items relative to the fatigue symptom).


Eligibility Criteria:
Inclusion Criteria:

* Men or women 18 years old or more,
* Able to understand the protocol and to give their written consent,
* Health insurance.

Specific inclusion criteria:

* Group A: volunteers 18 to 30 yrs; without any pathology,
* Group B: volunteers ≥ 70 yrs; without any pathology,
* Group C: Performance status (ECOG) \< 4; patients included in CAPADOGE study presenting curative cares for cancer by chemotherapy and/ or surgery and/or hormonotherapy and/or radiotherapy.

Exclusion Criteria:

* Intense activity in 7 preceding days,
* Functional dependency,
* under a legal protection.

Specific non-inclusion criteria:

* Groups A \& B: serious chronic disease,
* Group C: Palliative care.
Validation of the French Version of the Health Assessment Questionnaire II (HAQ-II) for Rheumatoid Arthritis

The purpose of the study is to develop a validated French version of the HAQ-II questionnaire for rheumatoid arthritis.

The HAQ is the original Health Assessment Questionnaire used in rheumatology. It is available in more than 60 languages and includes 42 items. However the questionnaire is not easy to use in the clinic : complicated questions, long to answer for the patient and not easy to score for the doctor.

The HAQ-II is a reliable and valid 10-item questionnaire that performs at least as well as the HAQ and is simpler to administer and score. It includes 5 items already translated in English and 5 new items not yet translated.

The aim of the study is the validation of the French version of the HAQ-II for rheumatoid arthritis.

Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years old
* Patient with rheumatoid arthritis

Exclusion Criteria:

* None
CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma

The purpose of this clinical investigation is to evaluate the safety and effects of CCCR-modified NK92(CCCR-NK92)infusions in previously treated advanced non-small cell lung carcinoma(NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* 1.Male and female subjects with non-small cell lung carcinoma in patients with no available curative treatment options who have limited prognosis(≧3 months)with currently available therapies will be enrolled.
* 2.The last cytotoxic drug, radiotherapy or surgery≧4 weeks.
* 3.HB≧90g/L, ANC≧1.5×10e9/L, PLT≧80×10e9/L, TBIL≦1.5×upper limit of nomal, ALT/AST≦2.5×upper limit of nomal, ALT/AST≦5×upper limit of nomal if have liver metastasis, Cr≦1.5×upper limit of nomal or CCr≧60ml/min.

Exclusion Criteria:

* 1.Pregnancy or breastfeeding.
* 2.Known HIV, HBV or HCV infection.
* 3.Active antoimmune disease.
* 4.History of severe immediate hypersensitivity to any of the biological products including penicillin.
* 5.Severe psychiatric disorder which might interfere with the study treatment or examination.
* 6.Chronic heart failure NYHA≧III.
* 7.Simultaneous participation in another clinical trial within 4 weeks.
Effect of LPEC Compared With a Sham Procedure in the General Anesthesia

Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesia


Eligibility Criteria:
Inclusion Criteria:

* Intubation

Exclusion Criteria:

* ENT neoplasia
Cardiac Impairments Following Pediatric Cardiotoxic Anti-cancer Treatment

This study aims at investigating the feasibility of recruitment and application of a method regarding early detection of subclinical changes in cardiac health after completion of acute cancer treatment during childhood and adolescence.

Cardiovascular late effects following treatment for pediatric cancer are problematic. Early detection of subclinical changes is hardly possible using conventional diagnostic methods, but seems to be feasible during physical strain (exercise stress echocardiography).

This feasibility study examines as main objective the recruitment strategy and investigation method in 10-25-year olds in the first and fifth year after the end of acute anti-cancer therapy (n=40 participants with a history of childhood cancer and n=40 control subjects). The heart function is examined by means of exercise stress echocardiography and spiroergometry in comparison with healthy age- and gender-matched control subjects.

Secondary aims are the evaluation of aditional echocardiography markers and levels of physical activity.

Eligibility Criteria:
Inclusion criteria for all participants:

* Aged between 10 and 25 years
* Body height of ≥1,40m (required for performing the examination on the semi supine bicycle ergometer)
* Signed informed assent (minor participant) and consent (legal guardian and full-aged participant)

Additional inclusion criteria for participants following cancer treatment:

* Completion of acute cancer treatment with anthracyclines and/or chest radiation
* End of treatment 12 months and five years ago (± three months)
* Medical approval for study participation

Additional inclusion criteria for healthy control subjects:

- Appropriate as matched pair with respect to age and gender

Exclusion Criteria:

* Known cardiovascular diseases (incoherent with cardiotoxic treatment)
* Inability to follow study instructions (e.g., mental retardation, language)
* Acute orthopedic injury (e.g., bone fracture) or orthopedic impairments that preclude examination on a bicycle ergometer (e.g., instable prosthetic device)

All participants receive a basic physical and cardiological examination at rest as part of the study protocol to ensure capability before performing the exercise stress echocardiography.
Quality Control of a Strengthening Protocol in Subjects With Spinal Cord Injury

The aim of the master's thesis is to evaluate the clinic-internal strengthening concept of the Swiss Paraplegic Centre (SPZ). The SPZ is a rehabilitation clinic for spinal cord injured people. The strengthening concept has been routinely used since 2015.

By default, the patients complete - depending on which training phase they are in - three to four strength training sessions per week. As part of the master's thesis, the development of maximum strength of patients with spinal cord injury (SCI) in primary rehabilitation will be studied. It is explicitly taken care of that the patients comply with the training requirements. Furthermore, factors which prevent a consistent buildup of strength - such as medical complications (pressure sores, pneumonia, urinary tract infections) - are systematically recorded.

The findings should provide information on the effect and qualitative transfer of the existing strength concept in everyday clinical practice. The strength training performed is accompanied by the master student and documented in a standardized manner.


Eligibility Criteria:
Inclusion Criteria:

* Patients in initial rehabilitation
* SCI Level C1-C5 (ASIA Score C-D)
* SCI Lever C6-L5 (ASIA Score A-D)
* Traumatic and non-traumatic SCI
* Disease-related paraplegia, high-grade stenoses and central cord Syndromes
* Age \>= 18 years
* The maximum force is tested on three predefined training devices, two devices for the upper and a device for the lower extremity. The participants will only be included in the study if they are capable of succeeding in at least both exercises for the upper extremity

Exclusion criteria:

* Polyneuropathic diseases such as Critical Illness and Guillain Barré Syndrome
* Degenerative diseases such as multiple sclerosis and amyotrophic lateral sclerosis etc.
* Cognitive impairments
* Compliance of less than 2/3 of the training sessions
* ≥ 14 days without training
* more than 6 weeks between assessments