cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes

This trial is conducted in Europe.

The aim of this trial is to investigate the efficacy and safety of an intensified treatment regimen with preprandial insulin aspart and insulin detemir once or twice daily to a more convenient regimen with biphasic insulin aspart 30 twice daily on blood glucose control in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Duration of type 2 diabetes for at least 6 months since diagnosis
* Current treatment with one or two oral antidiabetic drugs for at least 3 months or with one or two oral antidiabetic drugs, given for at least 3 months in combination with intermediate or long-acting insulin/insulin analogue once daily
* BMI below 40 kg/m2
* HbA1c between 7-12%
* Able and willing to perform self-monitoring of capillary blood glucose

Exclusion Criteria:

* Current antidiabetic treatment with combination of three or more oral antidiabetic drugs
* Previous treatment with short-acting human insulin, short-acting insulin analogue or biphasic insulin/insulin analogue within the last 6 months (7 days or less within the last 6 months is allowed)
* Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
* Known or suspected allergy to trial product or related products
* Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures
* Receipt of any investigational drug within 4 weeks prior to this trial
* Previous participation in this trial
Efficacy and Safety of Intrathecal Morphine for Postoperative Pain Management Following Caesarean Section

The goal of this clinical trial is to learn if morphine added to the spinal anaesthesia can improve postoperative pain treatment for patients undergoing caesarean section, without increasing the risk of serious adverse events in mother and baby.

The main questions it aims to answer are:

* Is the treatment effective in preventing postoperative pain?
* Is the treatment safe for both mother and baby?

Participants will be given a normal spinal anaesthesia with addition of either morphine or sodium chloride (inactive substance). All participants will receive standard postoperative pain treatment, including morphine tablets as needed. Researchers will collect data from the electronic medical record and ask the participants to fill out questionnaires about pain levels and possible side effects.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years
* Singleton pregnancy
* Scheduled for planned caesarean section performed under spinal anaesthesia
* Written informed consent

Exclusion Criteria:

* Allergy to or contraindications towards trial medication
* Patients planned for postoperative epidural due to expected difficult postoperative pain management
* Patients planned for combined spinal-epidural as primary anaesthesia
* Inability to understand and read Danish
* Previous inclusion in the trial
Study of the Function and Muscle Metabolism in Drepanocytose Affected Patient During a Moderate Intensity Exercise

Drepanocytose disease is the first genetic disease in the world. It results in the synthesis of an abnormal hemoglobin (HbS), which in its deoxygenated form, polymerizes and leads to structural changes of red blood cells (RBC) which then take the shape of a sickle, become more fragile, more rigid and less deformable. The fragility of GR sickle causes their mass destruction, leading to chronic anemia (i.e. low levels of GR in the blood) associated with low tissue oxygenation. More rigid and less deformable, sickle GR tend to hang in the microvessels, leading to vaso-occlusive crises (CVO) particularly painful, can cause the failure of certain organs (spleen, kidneys, brain, lung, heart, liver , bone ...) and to life-threatening patients. Preliminary studies conducted on patients with drepanocytose disease (HbSS) have demonstrated changes of muscle tissue indicating a possible failure in the supply and use of oxygen. To date, the translation of this metabolic remodeling in the muscle work is not known.

This project's main objective is to evaluate muscle function in drepanocytose attempted patients. We hypothesized that muscle remodeling associated with sickle cell disease have a functional impact on strength and muscle metabolism. The main objective is to characterize the maximal voluntary plantar flexor muscles. The criteria for these targets will be based on the comparison between healthy subjects, carriers of the sickle cell trait (HbAS) and sickle cell patients (HbSS) oxygen saturation.

The strictly non-invasive approach proposed in this project will study the functional parameters of the muscle of sickle cell disease and the possible link with the clinical manifestations of the disease, including vaso-occlusive crisis, in which tissue oxygenation and pH plays a major role.


Eligibility Criteria:
Inclusion Criteria:

* Patient affected by sickel cells and healthy volonteers presenting no contre indication to spectrometry exam.

Exclusion Criteria:

* Patient affected by hemoglobinopathies other than drepanocytose
Milieu Teaching-AV (MT-AV Pilot)

This project will look at whether a novel approach to language intervention that encourages looking to audiovisual speech cues for infants with autistic older siblings (Baby Sibs), who are highly likely be diagnosed with autism or developmental language disorder (DLD). This study will specifically look at (a) whether caregivers find this approach to be easy to implement in their homes, (b) whether they find this approach to be acceptable, and (c) whether caregivers use the taught strategies in interactions with their infants.

This project will test the feasibility and acceptability of a novel approach to language intervention based on Milieu Teaching (Milieu Teaching-AV) that encourages looking to audiovisual speech cues for infants with autistic older siblings (Sibs-autism), who are highly likely be diagnosed with autism or developmental language disorder (DLD). The main question\[s\] it aims to answer are:

1. Can caregivers be trained in Milieu Teaching-AV, such that they are using the trained strategies in play with their infant children?
2. Do caregivers find these procedures to be acceptable and feasible to use in their everyday life.

Eligibility Criteria:
Inclusion Criteria:

* an older sibling with an autism diagnosis, confirmed by either (a) a detailed developmental interview and administration of the Autism Diagnostic Observation Schedule or (b) by record review
* monolingual English-speaking household

Exclusion Criteria:

* adverse neurological history
* known genetic condition
* pre-term birth (gestation \< 37 weeks)
* caregiver report of a diagnosed vision impairment or hearing loss
Coagulation Profile in Patients Undergoing Coronary Angiography and Percutaneous Coronary Intervention

The activated clotting time (ACT), global thrombosis test (GTT-3), platelet inhibition P2Y12 (VerifyNow) test and serum coagulation factors will be measured in patients undergoing coronary angiography (CA) and percutaneous coronary intervention (PCI).

The activated clotting time (ACT), global thrombosis test (GTT-3) and platelet inhibition P2Y12 (VerifyNow) test and serum coagulation factors will be measured in patients undergoing coronary angiography (CA) and percutaneous coronary intervention (PCI) - 20 smoking and 20 non-smoking.The measurements will take place: before coronary angiography (CA), 10 minutes after unfractionated heparin (HNF), 2h after CA, 6h after CA, 30 days after CA

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled do CA \>18 years old

Exclusion Criteria:

* pregnancy
* previous treatment with P2Y12 inhibitors, novel oral anticoagulants (NOAC) or warfarin acenocoumarol in last 24 hours
Functional Outcomes Following Limb Sparing Surgery for Sarcoma Patients

Primary Objectives:

1. To classify the types of wound healing complications that occur after pre-operative radiation therapy and limb sparing resection for the treatment of soft tissue sarcomas of the extremity.
2. To evaluate the impact of each complication type on patient function and quality of life using the Toronto Extremity Salvage Score (TESS).


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of soft tissue sarcoma with histopathologic confirmation.
2. Treatment protocol that includes pre-operative radiation therapy.
3. Treatment protocol that includes limb-sparing surgical resection.
4. Patient has received MD Anderson Cancer Center multidisciplinary care.
5. Patient must be at least three years post-operative.

Exclusion Criteria:

1. Previous radiotherapy to the local site.
2. Presence of regional or distant metastases.
3. Major medical co-morbidities (eg. cerebrovascular accident, congestive heart failure, concurrent malignancy) or disabilities unrelated to treatment for soft tissue sarcoma.
Innovative Physical Therapy Modalities in People With a Neurological Disease: Oculomotor Therapy and Adapted Yoga

Physiotherapy is a discipline which englobe not only the rehabilitation of physical pathologies but also their prevention. That is why this study pretends to upgrade this part of the physical therapy specialty while prove new therapies using innovation technologies in people with any physical neurological disease. The main problem that this study pretends to solve is the necessity of develop new activities to improve quality of life and integration in people with any physical neurological disease.

People with any neurological disease used to present visual problems, pain, fatigue, functional dependence, and a bad quality of life and it appears that exercise habits could improve all these deficiencies. However, how could people with any physical neurological disease participate in an integrated way in nowadays physical activities? The main objective of this study is to prove the effectiveness on visual acuity, quality of life, pain decreasing, functional independence and fatigue of physical therapy modalities in people with any physical neurological disease.

The experiment will take part with 128 participants, divided equally in control and experimental groups. Both are going to receive adapted yoga sessions but only experiment group is going to test oculomotor therapy. Descriptive investigation would take part at the end of the intervention to analyze all results.

Participants will complete several questionnaires at the start and at the end of the study, to quantify the progress. Also, a professional will evaluate the sessions.

Sessions are going to be online and offline, and both will be recorded (with the registered permission of the participants), so they could be analyzed lately.

Eligibility Criteria:
Inclusion Criteria:

* Users equal or over 18 years old.
* To have already signed all the obligatory documents.
* To have a physical neurological disease.
* To have an electronic with internet connection.
* To collaborate on the correct develop of the project.

Exclusion Criteria:

* Serious cognitive or physical damage.
* Doctor disapproval.
* Be unable to understand the indications.
* Be unable to read.
Clinical Trial of Lithium Carbonate Combined With Neo-adjuvant Chemotherapy to Treat Osteosarcoma

The purpose of this study is to determine whether Lithium Carbonate combined with neo-adjuvant chemotherapy improve the prognosis of osteosarcoma

Osteosarcoma is the most common primary malignant bone tumor in childhood and adolescence, the prognosis for the disease is poor. What's more, chemotherapy resistance and serious myelosuppression occur frequently in clinical further hindered canonical adjuvant chemotherapy. In our previous researches, we observed that GSK-3B positively regulates the NF-kB pathway to promote proliferation and tumorigenicity in osteosarcoma cell. Targeted inhibition of GSK3beta showed an obvious antitumor effect. It is a promising therapeutic target in osteosarcoma, especially if GSK-3b inhibition is combined with chemotherapeutic drugs. Lithium carbonate, commonly use in clinical application because of its fine quality and cheap price, was proven to be effected as a kind of GSK3beta inhibitor and stimulating factor of peripheral blood leukocyte. Therefore, lithium carbonate theoretically possesses effects of both anti-tumor as well as improvement of myelosuppression. We look forward to the results of clinical trials to test the effect of combinations of chemical drugs with lithium carbonate on myelosuppression, disease-free survival rate and lung metastasis rate in patients with osteosarcoma who treated with conventional chemotherapeutic regimens and wide resection. This study is a multi-centre, double-blind, randomized clinical trial phase 4. The inclusion criterion is patients with primary osteosarcoma in femur, tibia and humerus（IIB）. With the help of statistic method, 400 patients were randomly divided into two groups according to sequence of entering the group: lithium carbonate group and control group (1:1). Patients were suggesting continuing this trial until the end of the chemotherapy regimen or being confirmed as disease progression by RECIST guiding principles. According to their histological types, patients are analyzed using subgroup analysis. Disease evaluation will be conducted every 8 weeks. A follow-up to count the overall survival rate after grouping was performed within at least 24 months or at most 120 months. Our study may represent a novel and feasible approach by combination of conventional chemotherapy drugs and targeted drugs. More importantly, it may hopefully be a promising strategy to improve overall survival of osteosarcoma.

Eligibility Criteria:
Inclusion Criteria:

* histologically diagnosed primary classical osteosarcoma in extremities
* staging IIB
* MRI showing no skip lesion
* receive standard neo-adjuvant chemotherapy, adjuvant chemotherapy,and standard surgical treatment

Exclusion Criteria:

* a history of non-standard treatment(chemotherapy or surgery)
* secondary osteosarcoma or well-differentiated parosteal osteosarcoma
* evident dysfunction of cardia,liver and kidney, or pregnant women or women during lactation
Health-related Quality of Life in Patients Undergoing Surgery for Pectus Carinatum

The purpose of the study is to assess changes in health-related quality of life in patients undergoing surgical correction of pectus carinatum. In addition, the study assessed long-term effects of surgical intervention in relation to the development of persistent postoperative pain and / or sensory disturbances in the surgical field.


Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing surgery for pectus carinatum

Exclusion Criteria:

* patients without pectus carinatum
Use of E-health Based Exercise Intervention After COVID-19

Reduced subjective and objective functional capacity performance are reported after COVID-19 in a large proportion of subjects. The aim of this study is to examine the feasibility and effect of using an e-health tool for guidance and tracking of exercise training in a general population of adults previously infected by COVID-19.

Both hospitalized and non-hospitalized persons who have undergone extensive multi-disciplinary rehabilitation programs report significantly improved physical function after rehabilitation. Exercise training may be the key intervention to improve fitness and subjective complaints such as fatigue, low physical fitness and dyspnea after COVID-19 infection. However, traditional group-based exercise training or self-training programs at fitness centers have been shut down during the pandemic, and home-based interventions are warranted. To overcome the limitations and costs of a fitness center/personal trainer-based intervention study, more knowledge on the effectiveness and efficacy of using an e-Health system to recruit, train and monitor participants after illness are needed.

Eligibility Criteria:
Inclusion Criteria:

* Persons who have undergone COVID-19 disease
* People who struggle to be physically active enough as a result of corona disease
* People who experience reduced physical fitness as a result of corona disease

Exclusion Criteria:

-- more than 100 PAI per week (calculated from self-reported activity level)

* uncontrolled hypertension (high blood pressure) (over 200/110).
* symptomatic valve failure, hypertrophic cardiomyopathy, unstable angina, pulmonary
* hypertension, heart failure and/or severe rhythm disturbances
* cancer that makes participation impossible or exercise contraindicated. Considered individually in consultation with the attending physician.
* chronic contagious infectious diseases.
* Participates in other studies that are not compatible with participation in this project
* Post-exertional symptom exacerbation (PESE)/post-exertional malaise (PEM)/post-exertional neuroimmune exhaustion (PENE).
Modified CD19 CAR-T in Patients With Relapsed or Refractory CD19+ B-cell Malignancies

This study aims to evaluate the safety and tolerance of modified CD19 CAR T cells in treating refractory/relapsed B-cell malignancies. CAR-T cells will be investigated as a single agent both in relapsed/refractory B-cell acute lymphoblastic leukaemia (B-ALL) and up to 60% of patients with B-cell non-Hodgkin's lymphoma (NHL).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18-70 years;
2. Estimated survival time ≥ 12 weeks;
3. Histologically confirmed diagnosis of CD19+ B-ALL or CD19+ B-NHL(meeting one of the following conditions):

   1. Ineffectively or relapses after 2 or more remedial treatments
   2. Relapse after auto-HSCT or unsuitable for auto-HSCT;
4. At least one assessable tumor lesion;
5. ECOG performance status 0 to 2;
6. Creatinine clearance rate≥ 60 ml/min, ALT and AST ≤ 2.5 times of upper limit of normal, total bilirubin ≤ 1.5 times of upper limit of normal;
7. Male and female of reproductive potential must agree to use birth control during the study and for at least 30 days post study;
8. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Patients with other uncontrolled malignancies;
2. Previously treated with any CAR-T cell product or other genetically-modified T cell therapy;
3. Patients with HIV infection, hepatitis B (HBsAg positive) or hepatitis C（anti-HCV positive);
4. Patients with central nervous system involvement by lymphoma ,malignant cells in cerebrospinal fluid or history of brain metastasis;
5. Patients with atrial or ventricular involvement by B-cell malignancies;
6. Patients with tumor mass require urgent treatment, such as ileus or vascular compression;
7. Patients with severe disease or other uncontrolled diseases that were not suitable for this trial, such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, grade 2-3 hypertension;
8. Unstable pulmonary embolism, deep venous embolism, or other major arterial/venous thromboembolism events occurred within 30 days prior to randomization. If patients receive anticoagulant therapy, the treatment dose must be stable prior to randomization;
9. Any situations that the investigators believes were not suitable for this trial;
10. Long-term use of immunosuppressive agents after organ transplantation, except for the patients recently or currently receiving inhaled steroids;
11. Pregnant(or lactation) women;
12. Patients with severe active infections(excluding simple urinary tract infection and bacterial pharyngitis)within 30 days prior to randomization
Lipidomics and Functional Analyses of Platelets in Fabry Disease

This study aims to evaluate whether platelets are biochemically and functionally altered in Fabry disease (FD) and therefore possibly implicated in FD manifestations such as cerebrovascular events. To test this hypothesis the investigators aim to compare platelet and plasma lipid profiles, as well as platelet function and coagulation parameters of FD patients and healthy controls.

Fabry disease (FD) is a severe X-linked inborn error of the lysosomal glycosphingolipid metabolism. FD patients have significantly increased risks for cardiac and cerebrovascular events, which can also occur early and in absence of the typical FD symptoms. However, the pathophysiological mechanisms leading to vascular occlusion and ischemia in FD are largely unclear. Prevention of recurrent cerebrovascular events is usually based on empirical anti-platelet therapy.

Prothrombotic states and partially activated platelets have been reported for FD patients. Platelets contain glycosphingolipids, including globotriaosylceramide (Gb3), and have lysosomal α-galactosidase activity. To investigate whether the lack of or the reduced α-galactosidase enzyme activity present in Fabry disease affects platelet lipid metabolism the investigators plan to perform LC-MS-based lipidomics analyses of platelets and plasma in FD patients and healthy controls. To assess whether platelets are functionally altered in FD, the investigators aim to determine the activation status, activability, aggregability and other parameters along with plasma markers of coagulation using flow cytometry, aggregometry and immunoassays.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers: without any known cardiovascular, cerebrovascular and renal diseases and without any known conditions affecting platelet function, blood coagulation and lipid metabolism.
* Patients: Genetically confirmed Fabry Disease
* Adult persons (18-65 years old), both female and male
* Informed written consent

Exclusion Criteria:

* Failure to meet inclusion criteria
* Pregnancy (as declared by the study participant, no pregnancy test will be performed)
The Efficacy of Hyperemesis Gravidarum on Macular Thickness, Corneal Thickness and Intraocular Pressure in Pregnancy

Aim

Physiological changes in intraocular pressure as well as in the cornea and macula may occur during pregnancy.

In the literature, there are limited data on ocular findings in hyperemesis gravidarum. Therefore, we have decided to investigate the effect of hyperemesis gravidarum on macular thickness, corneal thickness and intraocular pressure (IOP).

A total of 110 people, 55 of whom were diagnosed with hyperemesis gravidarum and 55 of whom were in the control group, were included in the study. The inclusion criteria for the study were as follows: First trimester (8-14 weeks of gestation) pregnancy with positive fetal heartbeat and no history of systemic disease; no continuous use of medication; diagnosis of hyperemesis gravidarum (ketonuria and weight \> 3 kg or 5% of the body) and the occurrence of less than three vomiting attacks per day with loss of weight; body mass index (BMI) within normal limits; being between the ages of 18 and 40; not drinking alcohol or smoking. A total of 94 patients, 40 of whom were diagnosed with hyperemesis gravidarum and 54 healthy pregnant women, were divided into two groups by recording their age, BMI, laboratory and eye findings.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for the study;

  * First trimester (8-14 weeks of gestation) pregnancy with positive fetal heartbeat and no history of systemic disease ,
  * no history of continuous drug use,
  * Diagnosis of hyperemesis gravidarum (ketonuria and weight \>3 kg or 5% of the body) The occurrence of \>3 vomiting attacks per day with loss of weight,
  * Body mass index (BMI) within normal limits,
  * Being between the ages of 18-40 ,
  * not drinking alcohol or smoking,
  * not using any vitamins or supplements use during the study

Exclusion Criteria:

* Any patient who did not meet the inclusion criteria was excluded from the study.
* Patients who participated in the study but later gave up