cyrilzakka/clinical-trials huggingface dataset:
Clinical Study on Modified Allogeneic Hematopoietic Stem Cell Transplantation Regimen for Severe Aplastic Anemia

The aim of this study was to evaluate the safety and efficacy of a modified allogeneic hematopoietic stem cell transplantation regimen for aplastic anemia.

ObjectiveTo evaluate the safety and efficacy of a modified allogeneic hematopoietic stem cell transplantation regimen in aplastic anemia. Aplastic anemia (AA) is a group of myelo-hemopoietic failure syndromes caused by a variety of etiologies. If not intervened, the average expected survival time is less than half a year.Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is one of the possible cures for this disease. The success rate of treatment for this disease can be further improved under the previous regimen system. The survival rate reported in the literature is 60%-90%. We designed this study to improve the conditioning regimen and optimize the GHVD prevention measures to improve the transplant success rate and prolong patient survival, while minimizing the occurrence of GVHD and reducing the recurrence rate of the disease.30 patients with aplastic anemia were planned to be enrolled.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with benign or malignant hematological diseases such as leukemia, lymphoma, thalassemia, aplastic anemia, etc. diagnosed by NCCN guidelines, and requiring allogeneic hematopoietic stem cell transplantation as determined by the researchers;
2. Age 3-65 years old;
3. Weight 10Kg-100Kg;
4. Eastern Cooperative Oncology Group (ECOG) score ≤3;
5. No major organ injury (ECG ejection fraction \>45%; bilirubin \< 2 times the upper limit of normal value; AST and ALT \< 3 times the upper limit of normal value; serum creatinine \< 2 times the upper limit of normal value);
6. No severe infection;
7. Subjects voluntarily participated in this clinical trial and signed the informed consent.

Exclusion Criteria:

1. patients with nonhematologic diseases who are not eligible for transplantation or who do not wish to receive transplantation;
2. patients with an expected survival of less than 1 month;
3. patients with previous autologous or allogeneic hematopoietic stem cell transplantation;
4. pregnant patients;
5. patients with severe mental or neurological disorders that would affect the ability to provide informed consent and/or to report or observe adverse events;
6. other conditions that the investigator determines to be inappropriate for enrollment.
Optimizing the Approach of Mobile Application Use to Improve Medication Adherence in Patients With Hypertension

The purpose of this study was to determine the effectiveness of using a custom-designed mobile application to improve blood pressure (BP) and promote adherence to antihypertensive medication regimens. This was a prospective, multicenter, randomized controlled trial. Patients were randomized to an intervention or control group for three months. Antihypertensive medication refill history was assessed three months before, during and three months after the study period. Continuous outcome measures investigated were systolic/diastolic BP and medication refill history, using the cumulative medication gap (CMG) score.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Diagnosed with hypertension as evidenced by diagnosis codes or chart documentation
* Prescribed at least one antihypertensive for a minimum of three months prior to enrollment
* Have access to an Android mobile device with data capabilities
* Consent to using the application on their device

Exclusion Criteria:

* Do not read or speak English
* Unable to read and sign the informed consent or Health Insurance Privacy and Accountability Act (HIPAA) waiver
* Too ill or cognitively impaired to participate
QStat Cartridge in Obstetric Patients

This study will assess the performance of the Quantra System with the QStat Cartridge versus standard of care coagulation testing in pregnant women at risk of bleeding at delivery.

The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The QStat Cartridge was developed to monitor hemostasis in patients that may experience a range of coagulopathies of various etiologies including fibrinolytic defects. These patients include the tobstetric hemorrhage population. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding five parameters that depict the functional status of a patient's coagulation system.

This multicenter, prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to standard of care coagulation testing in pregnant women at risk of bleeding at delivery.

Eligibility Criteria:
Inclusion Criteria:

* Subject is greater than18 years.
* Subject is pregnant or at least 24 h postpartum
* Conventional coagulation tests and/or viscoelastic testing are ordered for concern of possible coagulopathy based on one or more clinical scenarios including hemorrhage, suspected or confirmed placental abruption, amniotic fluid embolism, or placenta accreta spectrum
* Subject or subject's LAR is willing to provide informed consent, either prospectively or by deferred consent.

Exclusion Criteria:

* Subject is younger than 18 years old.
* Subject or subject's LAR is unwilling or unable to provide informed consent, either prospectively or by deferred consent.
* Subject is incarcerated at the time of the study.
* Subject is currently enrolled in a distinct study that might confound the results of the proposed study
* Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks
Freezing of Gait in Parkinson's Disease

This study is designed to evaluate whether a specific visuospatial training task will change gait performance of Parkinson's disease (PD) patients in doorways, specifically freezing of gait.

This study is a randomized, prospective, single-blinded six-week study in PD patients with freezing of gait (FOG).

This study will involve 2 study groups:

Group A - training group; Group B - no training group/controls.

Both groups will complete a gait evaluation and neuropsychological testing. Group A will also practice an in-home visuospatial task for 30 minutes, 4-6 days per week for six weeks. Group B will not complete the in-home tasks.

Participation in this study is expected to last 6-8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age: greater than 18 years old and without an upper age limit
* diagnosis of idiopathic PD exhibiting at least 2 or 3 cardinal signs (bradykinesia, rigidity, and resting tremor)
* Ambulate independently without an assistive device for at least 60 meters
* Freezing of gait episodes confirmed through the FOG-Q and evaluation by a fellowship trained Movement Disorder neurologist
* Willingness and ability to participate in training and complete training diary
* Documented FOG-Q and Unified Parkinson's Disease Rating Scale (UPDRS) II
* Ability to sign informed consent
* Pregnant females will be included in the study and there are no known risks to the pregnant female or fetus

Exclusion Criteria:

* Inability to complete questionnaires
* Unwillingness to participate in training, complete all questionnaires and training diary
* Subjects with secondary causes of parkinsonism
* Significant dementia (MOCA \<20)
* Prior deep brain stimulation (DBS) surgery or pallidotomy
* Subjects cannot participate in any form of Physical Therapy, Occupational Therapy or Speech Therapy during the study period
* Subjects cannot start any new medications during the study period.
A Clinical Study of iNSC Intervent Cerebral Hemorrhagic Stroke

This is a single centre、single arm、open-label，to investigate the safety and efficacy of induction of neural stem cells transplantation in the brain


Eligibility Criteria:
Inclusion Criteria:

1. Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study procedures.
2. Men and women 30-65 years old.
3. Women must have a negative serum pregnancy test, gestation age women practice an acceptable method of contraception.
4. At least 12 months but no more than 60 months from time of hemorrhagic stroke, with a motor neurological deficit.
5. Documented history of single hemorrhagic stroke in subcortical region of MCA or lenticulostriate artery with or without cortical involvement, with correlated findings by MRI.
6. Modified Rankin Score of 2, 3 or 4.
7. FMMS score of 55 or less, two evaluations at approximately 3 weeks apart prior to surgery with less than +/- 5 point change in the FMMS.
8. Two evaluations at approximately 3 weeks apart prior to surgery with less than +/- 4 point change in the NIHSS.
9. Able and willing to undergo post-physical therapy/rehabilitation.

Exclusion Criteria:

1. Any disabling psychological or psychiatric disorders which may confound the study.
2. History of more than one hemorrhagic stroke.
3. History of another major neurological disease or injury.
4. Cerebral soften lesion size \>5cm in any one measurement.
5. Myocardial infarction within the prior 3 months.
6. History of seizures or current use of antiepileptic medication.
7. History of peripheral nerve surgery, including Selective Dorsal Rhizotomy and Contralateral Seventh Cervical Nerve Transfer.
8. Receipt of any investigational drug or device within 30 days.
9. Receipt of any cell infusion other than blood transfusion.
10. Any concomitant medical disease or condition noted below:

    1. Coagulopathy.
    2. Active or history of malignancy.
    3. Primary or secondary immune deficiency.
    4. Persistent MRI artifact or unable to undergo MRI.
11. Any condition that the Investigator or primary physician feels may interfere with participation in the study or may endanger the subject.
12. Any condition that the surgeon feels may pose complications for the surgery.
Clinical Evaluation Of Class I Composite Resin Restorations Using Three Different Adhesive Systems

Nowadays, most composite resins require the use of an adhesive material prior to application. For this purpose, etch \& rinse (ER) and self-etch (SE) systems have been used for many years. While many in-vitro studies have been conducted in the literature comparing three adhesive systems, the number of clinical studies is less and inadequate. Therefore, the aim of this study was to investigate the effect of 3 different adhesive systems commonly used in clinics on the success of class I composite restorations using the criteria of the World Dental Federation (FDI) and the United States Public Health Service (USPHS).

Nowadays, most composite resins require the use of an adhesive material prior to application. For this purpose, etch \& rinse (ER) and self-etch (SE) systems have been used for many years. Compared to SE systems, which are simplified and very easy to use, requiring less technical precision, traditional ER systems are still very popular and preferred by dentists. However, current researchers indicate that ER systems are more effective on enamel than dentin and that this effect is better than SE systems. SE systems are approaches in which the acid application and washing step are eliminated clinically and the possibility of making mistakes during the application and manipulation is reduced. An important advantage of these systems is that demineralization and resin infiltration occurs at the same time. Clinically, the application times are shorter than traditional systems. Two-steps SE systems have been used for a long time. In this system, the need for a separate acidic primer application has needed clinicians reason to search for single-steps bonding agents. And, in recent years, single-step SE systems also called "all in one", have been developed that include all steps of pickling, primer application, and adhesive agent application. However, there are studies showing that these systems do not perform as well as two-step SE systems. While many in-vitro studies have been conducted in the literature comparing three adhesive systems, the number of clinical studies is less and inadequate. Therefore, the aim of this study was to investigate the effect of 3 different adhesive systems commonly used in clinics on the success of class I composite restorations using the criteria of the World Dental Federation (FDI) and the United States Public Health Service (USPHS).

Eligibility Criteria:
Inclusion Criteria:

* At least 3 Class-I caries lesions
* Good health
* Acceptable level of oral hygiene

Exclusion Criteria:

* Did not have four caries lesions at least
* Did not have Class-II caries lesions
* Deep caries reaching the pulp
* The patients are not 18-22 years old
* Bruxism
* Periodontal disease
* Refused to participate
Comparison of Two Titration Programs of Adding Insulin Detemir to OADs in Poorly Controlled Type 2 Diabetes

This study compared the effectiveness and safety of two treatment algorithms for insulin detemir initiation and titration: active titration algorithm (performed by investigator weekly) versus usual titration algorithm (performed by study subjects weekly) in patients with type 2 diabetes poorly controlled by OADs.

This is a 24-week, prospective, open-label, randomized, parallel-group study conducted in approximately 200 patients with type 2 diabetes in the Taiwan. The effectiveness of insulin detemir will be assessed at baseline and at 12 and 24 weeks after initiation of study prescription. The safety will be followed during the 24-week study period.

Inclusion criteria:

Patients must meet all of the following criteria:

1. Men and women with type 2 diabetes.
2. 20 years of age.
3. Patients who have received stable doses of any OADs for at least 10 weeks prior to the screening visit.
4. Patients with inadequate glycemic control (HbA1C \>=7% and \< 11%).
5. Patients who are willing and able to cooperate with study and give signed informed consent.

After enrollment, eligible patients will be randomized in a 1:1 ratio to one of the following titration algorithms:

* Active titration algorithm: contact with investigator by telephone weekly.
* Usual titration algorithm: contact with investigator only at routine study visit.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet all of the following criteria:

1. Men and women with type 2 diabetes.
2. 20 years of age.
3. Patients who have received stable doses of any OADs for at least 10 weeks prior to the screening visit.
4. Patients with inadequate glycemic control (HbA1C \>=7% and \< 11%).
5. Patients who are willing and able to cooperate with study and give signed informed consent.

Exclusion Criteria:

1. Patients with type 1 diabetes.
2. Renal dialysis patients.
3. History of hypoglycemia unawareness.
4. Patients who had received any insulin for more than 2 weeks or who have received insulin treatment within 4 weeks prior to screening visit.
5. Patients who have received any investigational products (drug and device) within 4 weeks prior to screening visit.
6. Patients hypersensitive with insulin detemir or its excipients.
7. Patients who are currently pregnant/lactating,or who are preparing for pregnancy or lactation.
Effects of Buprenorphine on Ulnar Nerve Motor Block

Recent reports showed that the opioid buprenorphine is a very potent sodium channel blocker. Buprenorphine not only exerts a strong antinociception, but also a long lasting antihyperalgesic effect. This antihyperalgesic effect is not observed for other clinically employed opioids but is common for local anaesthetics.

The principal aim of the study is to compare the speed of onset and the time of recovery of motor blockage achieved by lidocaine and buprenorphine, respectively. The investigators hypothesize that the blocking capacity of buprenorphine is equal to the one of lidocaine.


Eligibility Criteria:
Inclusion Criteria:

1. Male
2. Age: 18 - 65 years
3. Weight: 50-100kg
4. Height: 155-195cm
5. Signed and dated informed consent
6. Sufficient command of German language

Exclusion Criteria:

1. Contraindications to the class of drugs under study
2. Vulnerable subjects (intellectually or mental impaired)
3. Known hypersensitivity to class of drugs or the investigational product
4. Drug abuse
5. Known peripheral neuropathies
6. Diabetes mellitus
7. Chronic alcohol consumption
8. Congestive heart disease
9. Participants of other studies during study period
A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Autoimmune Hepatitis.

This study will evaluate the efficacy and safety of HR19042 capsules for the treatment of autoimmune hepatitis. It will also explore the optimal frequency and dosage of HR19042 capsules administration for the treatment.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years old≤Female or male patients≤70 years old；
2. Clinical-confirmed autoimmune hepatitis；
3. Biopsy-confirmed autoimmune hepatitis；
4. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 3 × upper limit of normal (ULN)；
5. Willing and able to give informed consent and follow the protocols during the trial.

Exclusion Criteria:

1. Patients with other chronic liver diseases；
2. Patients with liver cirrhosis；
3. Patients with hepatic encephalopathy；
4. Positive results in HIV-Ab/TP-Ab/hepatitis virus tests
5. Severe chronic or active infection requiring systemic anti-infective therapy within 14 days before screening；
6. Patients with severe cardiovascular diseases；
7. Patients with malignancy within the past 5 years；
8. Patients received organ transplantation；
9. Patients treated with any systemic corticosteroids within 3 months before screening；
10. Patients treated with any systemic immunosuppressive drugs within the 6 months before screening.
Using ctDNA to Detect Minimal Residual Disease After Lung Cancer Resection

ctDNALung-Detect is an investigator-initiated single arm, multi-institution study designed to assess the ctDNA detection rate and its association with Relapse Free Survival (RFS) in operable stage T1-T4 (T3,T4 multifocal) N0M0 non-small cell lung cancer (NSCLC) patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. Ability to provide written informed consent;
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
4. T1-T4 (T3,T4 multifocal) N0M0 NSCLC who are planned for complete surgical resection;
5. Tumour size must be at least 1 cm (unidimensional) and have at least some solid component on imaging;
6. Surgical tumour formalin-fixed, paraffin-embedded (FFPE) specimens for ctDNA studies are required.

Exclusion Criteria:

1. Prior radiation, surgery or chemotherapy for the current diagnosis of NSCLC is not permitted.
2. Incomplete surgical resection. Participants who had pre-operative ctDNA samples taken but subsequently do not have a complete surgical resection would not qualify for post-operative ctDNA testing.
3. Concurrent enrolment in a therapeutic study using drug or radiation therapy. Enrolment in observational, diagnostic or studies of novel surgical techniques will be allowed.
4. Concurrent active malignancy or other invasive malignancy within previous 2 years. Non-invasive malignancies (i.e., cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that has been surgically cured) are excluded from this definition.
5. Pregnancy.
621 Real World Study

This study is evaluating the clinical safety and effectiveness of 621, after cataract surgery.


Eligibility Criteria:
Inclusion:

1. Age ≥ 18 years old;
2. Patient with clinically significant cataract with planned phacoemulsification cataract extraction and implantation of IOL into the capsular bag;
3. Preoperative corneal astigmatism ≤ 1.00D;
4. Patient is willing and capable of providing informed consent;
5. Patient is willing and capable of complying with visits and procedures as defined by this protocol.

Exclusion:

1. Preoperative best corrected visual acuity \> 4.7 or ≤ 0.3 logMAR;
2. Corneal endothelial cell count less than 2000 cell/mm2;
3. Age under 18 years old;
4. Pregnant and lactating women;
5. Patients who attend other drug or medical device study;
6. Ocular disorder that could potentially cause a clinically significant future visual acuity loss;
7. Anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.)
8. Abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies);
9. Any condition in the study eye that could affect IOL stability (e.g. pseudo-exfoliation, zonular dialysis, evident zonular weakness or dehiscence, etc;
10. Any acute infection (acute ocular disease, external/internal infection, systemic infection);
11. History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy, amblyopia, strabismus, microphthalmia, aniridia, epiretinal membrane etc.) in the study eye that could alter or limit final postoperative visual prognosis;
12. Any previous intraocular and corneal surgery ;
13. Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment;
14. Current systemic or ocular pharmacotherapy that effects patients' vision;
15. Current pathology or condition that could be a risk for the patient according to the investigator opinion;
16. Patients unable to meet the limitations of the protocol or likely of non-cooperation during the clinical investigation;
17. Patients whose freedom is impaired by administrative or legal order.