cyrilzakka/clinical-trials huggingface dataset:
Gammanorm Quality of Life Study in Immunodeficient Patients Using Rapid Push or Pumps

The purpose of this study is to compare satisfaction (LQI questionnaire, factor I: treatment interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL according to the delivery device.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years)
* Presenting with primary immunodeficiency
* Having received subcutaneous injections of immunoglobulin at home using an automatic pump for at least 1 month at the time of inclusion
* For whom the investigator decides to maintain immunoglobulin replacement therapy with subcutaneous injections of Gammanorm® 165 mg/mL at home
* Having signed an informed consent form

Exclusion Criteria:

* Patient currently participating in another interventional study at the time of inclusion
Radiofrequency Versus Laser Ablation for Hepatocellular Carcinoma

The purpose of this study is to prospectively compare percutaneous radiofrequency ablation (RFA) versus percutaneous laser ablation (LA) for the treatment of small hepatocellular carcinoma in patients with cirrhosis.

Percutaneous ablation is a safe and effective therapy for cirrhotic patients with HCC when resection or liver transplantation is not possible. Among the various percutaneous local ablative therapies, radiofrequency ablation (RFA) has attracted the greatest interest because of its effectiveness and safety for single HCC ≤ 5.0cm or ≤3 HCC nodules ≤3cm. Some studies have shown that laser ablation (LA) may be as effective as RFA in the treatment of HCC. However, RFA and LA are different techniques and, in different cases (for example: size or site of HCC nodule), each of these procedures may have some advantages or disadvantages. Therefore there is the need for a prospective randomized controlled study to compare RFA and LA in patients with small HCC.

Eligibility Criteria:
Inclusion Criteria:

* Patients with unresectable HCC or who refused surgery
* A solitary HCC ≤ 5.0cm in diameter, or multiple HCC ≤ 3 lesions, each ≤ 3.0cm in diameter
* Child-Pugh class A or B
* Platelet count correctable to \> 40,000/mm3, INR correctable to \< 2.0
* No previous treatment of HCC

Exclusion Criteria:

* Other severe concomitant diseases that may reduce life expectancy
* History of encephalopathy, refractory ascites or variceal bleeding
* Vascular invasion or extrahepatic metastasis
* Human immunodeficiency virus (HIV) infection
* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
* Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
Point of Care Testing of Inflammatory Markers in Tears

To evaluate the use of a point of care device to measure markers of inflammation in various eye conditions. In particular, matrix metalloproteinase-9 (MMP-9) will be measured. MMP-9 is an enzyme that plays a role in inflammation. The value obtained with the point of care device will be correlated with values obtained using gel electrophoresis to measure MMP-9 from the same sample. These data will be compared to clinical exam findings and questionnaires to help the investigators better understand the role of this marker of inflammation in eye diseases and possibly improve diagnostic abilities.

As a participant in the study a sample of tears will be collected in a non-invasive manner by sitting comfortably at the slit lamp (a slit lamp is the standard device used to examine the eye and merely requires the participant to sit upright and place their chin on a chin rest and their forehead up against the slit lamp apparatus). The participant will then be asked to look upwards and while gently lowering the lower eyelid, a sterile blunt glass pipette will be used to collect tears from the natural tear lake (the tear lake is a reservoir of tears that sits on the surface of the eye and above the lower eyelid). Collected tears will then be taken for analysis of inflammatory markers.

In addition, a survey to evaluate the symptoms and the symptoms impact daily life (Ocular Surface Disability Index Survey of National Eye Institute Visual Functioning Questionnaire- 25).

Eligibility Criteria:
Inclusion Criteria:

* Patients that present to clinic for evaluation. Patients with and without evidence of eye inflammation will be eligible for this study.

Exclusion Criteria:

* Patients outside the age limits will not be eligible for the study
Clinical Study of R744 to Peritoneal Dialysis Patients

This study will assess the efficacy and safety of subcutaneous or intravenous R744 in renal anemia patients on Peritoneal Dialysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have been receiving peritoneal dialysis for at least 12 weeks before registration
* Patients aged ≥ 20 years at the time of obtaining consent
* Patients who have been receiving a rHuEPO preparation at least once a month for at least 8 weeks before registration
* Patients whose mean value of Hb concentrations determined within 8 weeks before registration has been between 10.0 g/dL and \<12.0 g/dL
* Patients whose transferrin saturation has been ≥ 20 % or ferritin has been ≥ 100ng/mL at any one time point within 8 weeks before registration

Exclusion Criteria:

* Patients with hardly controllable hypertension (patients whose diastolic blood pressure has been ≥ 100 mmHg on more than 1/3 of the determining occasions within 12 weeks before registration
* Patients with congestive cardiac failure (≥ Class III in NYHA cardiac function classification)
* Female patients who are pregnant, lactating, possibly pregnant or not willing to take a contraceptive measure in the period from the day of starting the treatment with the study drug to 90 days after the day of the last dose of the study drug
* Patients with complication of myocardial infarction, pulmonary infarction or cerebral infarction (excluding asymptomatic cerebral infarction)
* Patients confirmed to have serious allergy or serious drug allergy (shock, anaphylactoid symptom)
* Patients hypersensitive to a rHuEPO preparation
* Patients with malignant tumor (including hemic malignant tumor), severe infection, systemic hemic disease (osteomyelodysplasia syndrome, hemoglobinopathy, etc.), hemolytic anemia or apparent hemorrhagic lesion such as digestive tract hemorrhage
* Patients who have had an onset of peritonitis within 4 weeks before registration
* Patients who have received an anabolic hormone preparation, testosterone enanthate or mepitiostane within 12 weeks before registration
* Patients who have received another investigational drug within 12 weeks before registration
* Patients who have received R744 before registration
* Patients whose AST(GOT) value ≥ 100 IU/L or ALT(GPT) value ≥ 100 IU/L before registration
* Patients who have received erythrocyte transfusion within 16 weeks before registration
* Patients for whom a surgical operation accompanied by marked bleeding is planned during the study period
* In addition, patients who are judged as ineligible to participate in this study by the investigator or sub-investigator
Mesenchymal Stem Cell Therapy of Dry Eye Disease in Patients With Sjögren's Syndrome

AMASS is a double-blinded randomized clinical trial with the purpose of investigating whether injection of allogeneic adipose-derived mesenchymal stem cells (ASCs) into the lacrimal gland (LG) results in increased ocular comfort compared to placebo.

AMASS is a double-blinded randomized clinical trial which will be performed at the Department of Ophthalmology, University Hospital of Copenhagen, Denmark. 40 patients with severe aqueous deficient dry eye disease (ADDE) due to Sjögren's Syndrome (SS) will be recruited from the Dept. of Ophthalmology, Rigshospitalet, and allocated in ratio 1:1 to either injection of allogeneic adipose-derived mesenchymal stem cells (ASCs) or placebo (vehicle, Crystore CS10) into the lacrimal gland (LG) in one eye. We hypothesize that injection of allogeneic ASCs into the LG increases tear production and reduce inflammation resulting in increased ocular comfort compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Sjögren's syndrome according to the 2016 American College of Rheumatology/European League Against Rheumatism classification criteria for primary Sjögren's syndrome
* OSDI-score ≥ 33
* Schirmer's test 1-5 mm/5 minutes
* NIKBUT \< 10 sec

Exclusion Criteria:

* LG volume on MRI \< 0,2 cm3 in the study eye
* Previous treatment with ASCs or other stem cell products in the LG(s)
* Reduced immune response (e.g. HIV positive)
* Pregnancy or planned pregnancy within the next 2 years
* Breastfeeding
* Topical treatment with eye drops other than to treat dry eye disease (DED)
* Any other disease/condition judged by the investigator to be grounds for exclusion, such as infection in or around the eye
The Effect of Suboccipital Release Technique in Individuals With Anxiety

The purpose of this study is to determine the immediate effect of the suboccipital release technique on trapezius muscle pain threshold, muscle activation, and anxiety level in individuals with anxiety.Thirty-six people with anxiety symptoms were included in the study. These people were divided into two groups, 18 control group and 18 treatment group. Upper trapezius muscle pain threshold, muscle activation and anxiety levels were evaluated. The experimental group received a single session of suboccipital release technique. The control group received a single session of sham suboccipital release. The evaluations were performed before and immediately after the treatment.The suboccipital release technique can increase the trapezius muscle upper part pain threshold and concentric muscle activation immediately after the application in individuals with anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Being over the age of 18
* Agree to participate the study

Exclusion Criteria:

* Use psychiatric, analgesic and antispasmodic drugs
Sodium Hypochlorite Pulpotomies in Primary Molars: Comparison With Conventional 20% Formocresol Pulpotomies

Formocresol (FC) is the most universally taught and most widely used pulpotomy medicament in the primary teeth. However, concerns have been raised over the use of FC because of its toxicity and potential carcinogenicity. A substitution for FC has been investigated but evidence is lacking to conclude which is the most appropriate technique for pulpotomies in primary teeth. Sodium hypochlorite (NaOCl) has been used in root canal irrigant for more than 80 years, and it is at present the most popular irrigant in root canal treatment. Studies have showed that NaOCl is biological compatible and is a very good antimicrobial solution without being a pulpal irritant. Recent studies using sodium hypochlorite as pulpotomy medicament in primary molars showed promising results. In this project, the investigators propose a randomized clinical trial, which will be performed in Pediatric Dentistry Department of the National Taiwan University Hospital, to compare the treatment outcomes between NaOCl and FC in human primary molars needing pulpotomy treatment. The aim of this sudy is to determining weather NaOCl is a suitable replacement for FC in the pulpotomy of human primary molar teeth. To assess this aim, 200 healthy children from 2.5 to 9 year-old, who have at least one primary first or second molars diagnosed to receive pulpotomy treatment will be recruited in this project. The involved teeth will be randomly assigned to the control group (dilute 20% Formocresol (DFC)) or experimental group (2.5% NaOCl). At 3, 6, 9, 12, 15, 18, 21 and 24 months post-treatment, the randomly assigned teeth will be clinically and radiographically evaluated by blinded independent evaluators to the treatment group. The differences will be statistically analyzed using chi-square test, Fisher exact test, and t-test, using a statistical significance at p\<0.05.

As Brief summary.

Eligibility Criteria:
Inclusion Criteria:

* healthy, American Society of Anesthesiologists (ASA) Physical Status classification system class I children
* age between 2.5 and 9 years old
* with one or more primary molars need pulpotomy treatment

Exclusion Criteria:

* children younger than 2.5 or older than 9 years of age
Clinical Evaluation of Shengdi Dahuang Decoction in the Treatment of Acute Hemorrhagic Stroke

The purpose of this study is to assess the efficacy and safety of Shengdi Dahuang Decoction in the treatment of acute hemorrhagic stroke by the randomized, controlled, double-blind, multi-center trial design project.

The main purpose of the study is to observe the clinical efficacy and safety of Shengdi Dahuang Decoction in the treatment of acute hemorrhagic stroke. This project is funded by Science and Technology Commission of Shanghai Municipality and will be carried out in 5 hospitals. Investigators will recruit 464 participants who meet the inclusion criteria and agree to participate in the research. Participants will be randomly assigned into experimental or placebo group. Granules of Shengdi Decoction is the therapeutic drug used in the experimental group. Each pack of the test drug contains 15 grams of rehmannia and 5 grams of rhubarb. While for the placebo group, each pack contains 2% rehmannia and rhubarb. Participants will receive a follow-up observation in the following 90 days. Modified Rankin Scale score (mRS), the mortality rate on day 7 and day 90 after treatment, National Institute of Health Stroke Scale (NIHSS), expansion rate of hematoma, the degree of edema and the expressions of inflammatory indicators will be detected to evaluate the clinical efficacy of Shengdi Dahuang Decoction.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria of acute intracerebral hemorrhage；
2. CT scan reveals cerebral parenchymal hemorrhage and the volume of hematoma is \<80ml;
3. The time from onset to confirmed diagnosis by CT scan is within 4 hours;
4. Enrolled and receive treatment within 12 hours from onset;
5. Age ≥18 years old;
6. Obtain approval from the patient or family members.

Exclusion Criteria:

1. The time from onset to confirmed diagnosis by CT scan is over 4 hours;
2. CT scan indicate that the sites of hemorrhage are in the cerebellum, brainstem and ventricle (note: in case of cerebral parenchymal hemorrhage combined with ventricular hemorrhage, patients will be excluded if the volume of ventricular hemorrhage is the larger one);
3. The volume of hematoma is above 80ml;
4. Glasgow Coma Scale (GCS) is ≤ 5 points;
5. The time from onset to confirmed diagnosis is over 12 hours;
6. Have a surgical treatment planning within 24 hours;
7. Cerebral hemorrhage caused by trauma, arteriovenous malformation, thrombolytic therapy, anticoagulant therapy or other reasons;
8. Patients with disabilities before onset (modified mRS score \> 2);
9. Patients with severe primary diseases of the heart, lung, liver, kidney, endocrine systems or hematopoietic system;
10. Patients who have participated in other clinical trials within the past 1 month;
11. Pregnant or nursing women;
12. Allergic constitution (allergic to more than two kinds of food or medications).
Study of Tesomet With Open-label Extension in Subjects With Hypothalamic Obesity (HO)

This study will evaluate the safety and efficacy of Tesomet (tesofensine + metoprolol) in subjects 18 years of age or older, with HO


Eligibility Criteria:
Key Inclusion Criteria:

* Subject and, if applicable, their parent or legal guardian must be willing to provide informed consent
* Diagnosis of HO secondary to damage to the hypothalamus
* Female subjects must be of non-childbearing potential
* At least 6 months since completion of therapy (chemotherapy, surgery, or radiation with resulting injury to the hypothalamus and/or the pituitary) with stable disease and lack of recurrence
* BMI 30.0 to 60.0 kg/m², inclusive
* Documented stable body weight (gain/loss \<10%) for at least 90 days prior to Screening
* Stable and well-managed pituitary replacement (eg, glucocorticoid, thyroid hormone, estrogen/progestin or testosterone, desmopressin, or growth hormone) for \>2 months prior to Screening
* Male subjects who are sexually active must be surgically sterile

Key Exclusion Criteria:

* Females who are pregnant, breastfeeding, or actively intending to become pregnant during the study
* Sitting BP that meets the following criteria after 5 minutes of rest at Screening:

  1. Systolic BP \>145 mmHg or \<100 mmHg; or
  2. Diastolic BP \>95 mmHg or \<70 mmHg
* Type 1 diabetes mellitus
* History of major depressive disorder within 2 years prior to Screening, or any history of other severe psychiatric disorder (eg, schizophrenia, bipolar disorder)
* Uncontrolled endocrine disorders (eg, Cushing syndrome, Addison's, hypothyroidism, hyperthyroidism)
* History of bulimia or anorexia nervosa
* Use of prohibited medications, including current use of selective serotonin reuptake inhibitors / serotonin-norepinephrine reuptake inhibitors (SSRIs/SNRIs)
Research on New Regimens for Retreatment Pulmonary Tuberculosis

Multi-center, prospective study is performed to investigate the efficacy of new short-course regimen for retreatment pulmonary tuberculosis patients.

To obtain optimized short-course regimen, decrease treatment cost and improve success rate.

China is the country with the second highest Tuberculosis (TB) burden in the world. Most of the retreatment TB patients may develop multi-drug resistant. The resistant rate of any of the anti-TB drug is 35.9%, and the multi-drug resistant rate is 15.4%. Retreatment TB becomes one of the factors which inhibit the decrease of morbidity and mortality of TB. It is also a tuff work in TB control. At present the standardized regimen for retreatment TB is 2SHREZ/6HRE or 3HREZ/6HRE. The drugs in the regimen are all first-line anti-TB drugs which are unsuitable for the high drug resistance prevalence, because the cure rate of this regimen is low and the adverse reaction is severe.

Our study is a national multi-center, prospective trail to investigate the efficacy of a new super-short regimen for retreatment TB patients. The new regimen consists of 5 drugs lasting 5 months. The cure rate and success rate of the new regimen is compared with standardized regimen usually 8-9 months in order to obtain the optimized regimen.

Eligibility Criteria:
Inclusion Criteria:

* Sputum confirmed diagnosis of retreatment pulmonary tuberculosis
* Must be able to swallow tablets
* Must be able to sign written informed consent form

Exclusion Criteria:

* Extra-pulmonary tuberculosis
* Diabetes
* Allergy to any of the medications in the regimen or pregnancy
* Liver disease
* Renal disease
* Metabolic disease
* Immune system disease
* Hematological disease
* Nervous system and mental disease
* Endocrine disease
* Malignant disease
* Receiving immunosuppressive therapy
* HIV/AIDS
* Alcohol addiction
Taurolidine Containing Antimicrobial CIED Wash to Prevent Infection

From January 1st 2020, any CIED procedure conducted with adjunct TauroPace™ CIED and pocket irrigation is enrolled in a consecutive manner and followed up in one centre. Follow-up is prospectively.

Before that date any CIED procedure conducted with adjunct antispetic pocket and CIED irrigation is evaluated retrospectively to form a comparable group.

All the hardware (leads, suture sleeves, pulse generator) is washed and the device pocket irrigated with an adjunct antimicrobial solution, which could be 3% hydrogen peroxide (H2O2), taurolidine in a galenic formulation or TauroPace™ (TP, Tauropharm, Bavaria, Germany), during any invasive procedure (new implantation, pulse generator replacement, lead repositioning or insertion, system upgrade or downgrade, revision) involving a CIED system at the authors' institute. Before 01/01/2020, the choice of antimicrobial solution was at the operator's discretion. These procedures were evaluated retrospectively. With change of policy on the first of January 2020, in every consecutive patient and procedure only TP is used. Patients were enrolled and followed consecutively in order of appearance. All CIED procedures performed at the author's institute between 01/01/2017 and 28/02/2022 are included for analysis. Patients who receive the galenic taurolidine formulation were excluded from analysis.

Eligibility Criteria:
Inclusion Criteria:

CIED procedure, signs PIC

Exclusion Criteria:

PIC not signed, minor
Sedline EEG Guided Depth of Anesthesia

The purpose of our study is to determine if monitoring sedation (how asleep patients are under general anesthesia) using a device called a Sedline Monitor affects the amount of anesthesia patients receive.

The main objective of this study is to determine if monitoring sedation using the FDA approved device, Sedline Monitor, affects the amount of anesthesia patients 65 or older receive during surgery. Reducing the anesthetic dose could result in less exposure of anesthetic medications to a high-risk patient population as well as a potential reduction in cost. Subjects will be randomized into either a control group or study group and have the Sedline Monitor placed on their head before the start of their already scheduled surgery. During the surgery, subjects in the control group will receive standard anesthesia care and the study group will receive anesthetic drug doses guided by Sedline Monitor processed EEG characteristics. When the surgery is complete, the Sedline Monitor will be removed and subject participation will be finished. The study team will also collect information about subjects from their medical records and use it for this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a scheduled surgery (laparotomy, hepatobiliary surgery, gynecologic surgery, and/or urologic surgery procedures) at Indiana University Health University Hospital that is expected to have at least a 3 day post-operative hospital stay.
* ASA class 1, 2, 3, or 4.
* Age 65 years or older.
* Male or Female
* Surgical procedure requiring general anesthesia.

Exclusion Criteria:

* Any previous diagnosis of dementia or other cognitive impairment.
* Any patient undergoing emergency surgery.
* Any patient undergoing surgery who is currently an inpatient.
* Patient refusal to participate in study.
* Any patient undergoing surgery that would prevent placement of the Sedline monitor leads (for example - surgery on the patient's forehead/scalp).
* Any physical, mental, or medical conditions which, in the opinion of the investigators, may confound the ability to assess the patient for delirium in the post-operative period.