cyrilzakka/clinical-trials huggingface dataset:
Mesenchymal Stem Cell Therapy for Type 1 Diabetes Mellitus Patients

The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) transplantation for type 1 Diabetes Mellitus patients.

Mesenchymal stem cells (MSCs) are collected from autologous bone marrow mononuclear cells and allogeneic umbilical cord tissue (UC-MSC).

15 patients with type 1 Diabetes Mellitus will be enrolled and will receive MSCs by intravenous infusion. They were followed up for 6 months after transplantation.

Safety is to assess the occurrence of adverse events (AEs) during either stem cells infusion or by physician assessments.

The primary endpoint is to assess the improvement of patients' Fasting blood glucose, HbA1C, C-peptide, and blood insulin level.

Eligibility Criteria:
Inclusion Criteria:

* Who is diagnosed with Type 1 Diabetes Mellitus according to the ADA, the patients meet at least one of the following criteria:

  * At least one autoantibody associated with Type 1 Diabetes Mellitus such as ICA or GAD.
  * Previously diagnosed at a medical facility with Type 1 Diabetes.
  * Having evidence of insulin depletion based on the test results during screening.
* Patients treated with fixed insulin dose for at least 3 months.
* Males and females between age 18 and 45 years at the screening.
* Patients able to read, write and understand ICF form

Exclusion Criteria:

* Uncontrolled blood pressure at the time of enrollment: systolic pressure \>160 mmHg and/or diastolic blood pressure \> 100 mmHg.
* Having evidence related to renal dysfunction:

  * creatinine \> 1.5 mg/dl or (\>133 mmol/L) for men.
  * creatinine \> 1.4 mg/dl or (\>124 mmol/L) for woman.
  * eGRF \< 40 ml/ min
* Proteinuria \> 300 mg/day
* Having evidence of ketoacidosis at the time of selection.
* Having evidence of ongoing or frequent hypoglycemia.
* Having severe infection
* Infected with hepatitis B virus or hepatitis C or tuberculosis. Positive results of HbsAg or Anti HCV or/and PCR tuberculosis are only acceptable in case of vaccination and without suspicious signs. All other cases are not accepted even in the absence of clinical signs.
* Diseases detected before/during screening such as cardiovascular disease, respiratory disease ( pulmonary, fibrosis, chronic respiratory failure), liver disease, cancer, neurology, metabolism.
* Having abnormalities in red blood cells such as sickle cells disease.
* Using alcohol and/or tobacco.
* Blood clotting disorders (INR \> 1.5, PTT \>40, PT \> 15).
* Taking any anticoagulant.
* Taking systemic steroids.
* Participate in another clinical study involving experimenting drugs and/or medical equipment.
* Patients who are unable to perform the tests and assessments needed for the study (eg, patients who are unable to perform bone marrow transplantation) or patients who do not agree to participate in the study.
AI-based Physiotherapy for Oral Cancer Patients

This study examines the effects of AI-based physiotherapy on oral function, shoulder function, whole-body physical function, and quality of life in oral cancer patients. One hundred patients will be recruited before surgery, chemotherapy, or radiotherapy and randomly assigned to an experimental group receiving 12 weeks of AI-guided physiotherapy or a control group receiving usual care. Both groups will perform jaw, neck, and shoulder exercises, with the experimental group using a mobile app to monitor progress. Assessments at baseline, pre-intervention, and 3 months post-intervention will measure maximal in the maximum interincisal opening (MIO), joint range of motion (ROM), pain, endurance (e.g., 6-minute walk test), upper extremity function, and quality of life.

This study examines the effects of AI-based physiotherapy on oral function (e.g., mouth opening), shoulder function (e.g., shoulder joint range of motion and upper extremity function), whole-body physical function (e.g., 6-minute walk test), and health-related quality of life. 100 newly diagnosed oral cancer patients will be recruited before surgery, chemotherapy, or radiotherapy and randomly assigned to two groups. The experimental group will receive AI-based physiotherapy for 12 weeks, including postural correction exercises guided by AI technology, while the control group will receive usual care. Both groups will perform jaw, neck, and shoulder exercises, with the experimental group using a mobile app to monitor progress and record their exercise diaries. Assessments at baseline, pre-intervention, and 3 months post-intervention will measure the maximum interincisal opening (MIO), joint range of motion (ROM), pain, endurance, and upper extremity function using the Disabilities of the Arm, Shoulder, and Hand (DASH) scores, and quality of life using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed oral cancer patients who are scheduled to receive cancer-related treatments (e.g., oral cancer surgery, radiotherapy, chemotherapy, or chemoradiotherapy).
* Age between 20 and 65 years.

Exclusion Criteria:

* Could not communicate.
* Had any disorder that could influence movement performance.
To Improve the Clinical Outcome of Ultrasound-guided Radiofrequency Ablation by NAVIRFA® Navigation System.

Ultrasonic-guided radiofrequency ablation is the most common minimally invasive treatment for liver cancer. This study will use my country's self-developed intelligent ultrasonic navigation tool (NAVIRFA® Navigation System) to assist in the puncture of the needle during ablation, to observe the operation time, Whether the needle accuracy, ablation effect and complications are different from the traditional free-hand ultrasonic guidance technology.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with malignant liver tumors less than three centimeters in size who are expected to suffer radiofrequency tumor ablation in the hospital.
2. At least 20 years old.

Exclusion Criteria:

1. Patients with abnormal coagulation function and low platelets are not suitable for ablation therapy after evaluation by the trial host.
2. Those who are unable to accept computerized tomography and MRI examinations, such as poor renal function or contrast agent allergy, are not suitable for examination after the evaluation of the test host.
Pain After Stroke, Part 2: Clinical Characteristics and Classification of Pain in Patients After Stroke

The purpose of this study is to investigate the prevalence of characteristics of pain in a cohort of patients with prior stroke suspected of having central post stroke pain, identified through a postal questionnaire.

Medical history, pain history, pain drawing, DN4, sensory examination.

Eligibility Criteria:
Inclusion Criteria:

* Possible neuropathic pain following stroke

Exclusion Criteria:

* Severe dementia
* Severe language barriers
* Patients who cannot cooperate
High-risk Influenza Vaccine Alert

The purpose of this study is to assess, prospectively, the effect on flu vaccination rates of salient alerts in the electronic health record that indicate a patient's high risk for flu and its complications. The investigators hypothesize that the salient alerts will lead to increased flu vaccination compared with a standard flu alert.

The CDC (Centers for Disease Control) recommends a flu vaccination to everyone aged 6+ months, with rare exception; almost anyone can benefit from the vaccine, which can reduce illnesses, missed work, hospitalizations, and death. One barrier to vaccination is a lack of "cues to action," and, in particular, the lack of direct recommendation from medical personnel; this barrier is arguably the most effectively overcome by a simple nudge of clinicians, compared with barriers such as negative attitudes toward vaccination, low perceived utility of vaccination, and less experience with having received the vaccine.

Geisinger partnered with Medial EarlySign (Medial) to develop a machine learning (ML) algorithm to help identify people at risk for serious flu-associated complications based on existing electronic health record data. Eligible at-risk patients will be randomized to an active control group (clinician will be shown a standard flu alert) or one of two experimental groups (clinician will be shown an alert indicating patient's high risk, with or without describing the patient's factors contributing to that risk).

Eligibility Criteria:
Patient Inclusion Criteria:

* Age 18+
* Have been determined to be in the top 20% of risk through Medial's ML algorithm
* Attend an appointment where the flu alert fires (Geisinger sets when flu alerts start and end--between \~9/1/2022 and \~4/30/2023, as well as the trigger conditions for the alert, which includes valid departments and visits and excludes contraindications like Guillain-Barre syndrome)

Clinician Inclusion Criteria:

* Any Geisinger clinician who sees patient-participants in our study for an appointment where their flu shot alert fires
A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial)

This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).


Eligibility Criteria:
Inclusion Criteria:

* Patients with HL who have received ASCT in the previous 30-45 days
* Patients at high risk of residual HL post ASCT
* Histologically-confirmed HL
* ECOG of 0 or 1
* Adequate organ function

Exclusion Criteria:

* Previous treatment with brentuximab vedotin
* Previously received an allogeneic transplant
* Patients who were determined to have a best clinical response of progressive disease with salvage treatment immediately prior to ASCT
* History of another primary malignancy that has not been in remission for at least 3 years
* Post ASCT or current therapy with other systemic anti-neoplastic or investigational agents
LEAF - Low Energy In Atrial Fibrillation

The purpose of the study is to demonstrate the efficiency on AT / AF prevention and termination of a new algorithm contained in the Medtronic AT500 Antitachycardia device in patients with conventional pacemaker indications.

Aim. More than 30% of patients (pts) implanted with a pacemaker are known to have atrial tachyarrhythmias (AT) despite medical treatment and about 20% of pts experience AT prior to implant. The Medtronic AT500TM is a new DDDRP pacemaker with extended memory and features designed for preventing and terminating AT. The objective of this European multi-center prospective crossover and randomized study is to evaluate efficacy of this device for decreasing AT burden, improving QOL and reducing symptoms and costs. Method. 243 pts are implanted with the AT500TM and followed at 1, 7 and 13 months after implant. All patients are selected for a dual chamber pacemaker indication plus at least two episodes of AT in the last 12 months. One month after implantation patients are randomized either to a six month therapy phase (activation of preventive and ATP pacing) or a six month observation phase (No AT prevention nor Therapy). Crossover (CO) takes place at seven months after implant and the endpoint is reached at 13 months. Symptom checklist and QOL questionnaires are completed by pts at enrollment and after the two randomization periods. At each follow-up, a Save to Disk (STD) of device-stored AT episodes is performed and hospitalization, visits and/or other examinations are reported for future cost evaluation.

Eligibility Criteria:
Inclusion Criteria:

* ACC/AHA Class I or II indication for dual chamber pacing and two symptomatic atrial fibrillation or flutter episodes in the three months prior to implant as well as ECG documentation of at least one episode in the prior year.

Exclusion Criteria:

* Patients with permanent/persistent AF, an indication for an implantable cardioverter defibrillator or class IV heart failure.
Special Investigation of Pregabalin for Fibromyalgia (Regulatory Post Marketing Commitment Plan)

To collect the efficacy and safety information of Pregabalin on Fibromyalgia patients related to their appropriate use in daily practice.

All the patients whom an investigator prescribes the first pregabalin should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Fibromyalgia
* Pregabalin naive patient

Exclusion Criteria:

* Clinical diagnosis of neuropathic pain
The Effect of Smoking and Non-surgical Periodontal Treatment on Gingival Crevicular Fluid Cyclophilin A and EMMPRIN Levels

This study aimed to investigate the effect of smoking and non-surgical periodontal treatment on gingival crevicular fluid CyPA and EMMPRIN levels in patients with periodontitis. Twenty-eight patients with periodontitis (14 non-smoker and 14 smoker) and 30 control subjects (15 non-smoker and 15 smoker) were included into the study. Non-surgical periodontal treatment was applied to all periodontitis patients. Periodontal parameters and GCF CyPA and EMMPRIN levels were evaluated during 3 months following non-surgical periodontal treatment. GCF CyPA and EMMPRIN levels were analyzed by ELISA.


Eligibility Criteria:
Inclusion Criteria:

* generalized periodontitis with stage III-IV \& Grade B
* no systemic and periodontal diseases
* smokers (minimum 10 cigarettes per day for at least ten years)
* non-smokers (never smoked)

Exclusion Criteria:

* Systemic diseases
* Infectious diseases
* Pregnancy or lactating
* Having periodontal treatment during the last 6 months
* Having antibiotic treatment within the past 3 months
* Former smokers
Neurobehavioral Consequences of Sleep Apnea in Children

To identify physiological and clinical measures of obstructive sleep-disordered breathing that are associated with increased morbidity in children.

BACKGROUND:

The study is in response to a Request for Applications (RFA) on Obstructive Sleep Apnea in Children. NHLBI issued the RFA in December, 1997, with co-sponsorship from the National Institute of Dental and Craniofacial Research and the National Institute of Child Health and Human Development.

DESIGN NARRATIVE:

This cross-sectional study recruited a population-based sample of young children from among the more than 8000 children in Massachusetts enrolled in the on-going Infant Care Practices Study. Stratified sampling was used to assemble a cohort of 250 children with habitual snoring (\> 3 nights/week), 100 children with occasional snoring (\<3 nights/week), and 100 non-snoring children. These children were studied within 3 months of their fourth birthday using overnight laboratory polysomnography and a detailed neurobehavioral evaluation, in order to test the hypothesis that, after adjusting for potential confounding variables, both parent-reported snoring and polysomnographic measures were associated with standardized measures of the following neurobehavioral domains: immediate attention, sustained attention, working memory, and symptoms of hyperactivity. These data also provided an opportunity to determine normal values for polysomnographic measures in 4-year-old children and to determine the prevalence of snoring and polysomnographic abnormalities among 4-year-old children.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Comparison of the Application in Traumatic Brain Edema Between EIT and Non-invasive ICP Monitoring

Brain edema is the main reason for the disability and lethality in traumatic brain injury, which is the most difficult part of emergency rescue. Recently, there is no medical equipment to monitor the early brain edema in clinic. We have found that Electrical impedance tomography (EIT) can perform the real-time and bedside monitoring of brain electrical impedance after single-dose mannitol treatment, which may be a new strategy for the surveillance of brain edema. In this study, we would like to compare the application in traumatic brain edema between EIT and Noninvasive intracranial pressure (ICP) monitoring, including the progress of brain edema, the relationship between impedance and ICP, and the improvement for the patients' prognosis. EIT would probably be a new image strategy for the treatment of traumatic brain injury.


Eligibility Criteria:
Inclusion Criteria:

1. Eligible patients were 16 to 65 years of age with all genders.
2. The patients had been diagnosed as traumatic brain injury during 24 hours before enrollment, with the confirmation of CT or MRI.
3. All the patients had provided written informed consent.

6. The patients were receiving usual inpatient rehabilitation and conservative treatment .

Exclusion Criteria:

1. The patients with indication of operation during the research should be excluded.
2. The patients were assessed as unqualified for the study according to the comprehensive evaluation opinion brought forward by the research team.
Gonadotrophin Dosage Using a Threshold Nomogram for Ovulation Induction in WHO Group II Anovulatory Infertility

Ovulation disorders are a common cause of infertility in women. Most of these women can be classified as World Health Organization (WHO) Group II anovulatory patients as they have irregular or absent menstrual cycles but normal serum concentrations of follicle stimulation hormone (FSH) and estradiol.

The purpose of this study is to optimize the low-dose-step-up protocol traditionally used for ovulation induction with follicle-stimulating hormone (FSH) in women with anovulatory infertility WHO Group II.

Previous studies have established that menstrual cycle history, mean ovarian volume and BMI are significant predictors of FSH threshold dose in women with anovulatory infertility WHO Group II undergoing ovulation induction (Nyboe Andersen et al., 2008). A FSH dosage nomogram has been constructed based on these variables.

The aim of this study is to evaluate the clinical use of the nomogram in order to test the use of the variables to determine whether an individualized starting dose of FSH can be used for ovulation induction in anovulatory patients.

It is the hypothesis that an individualized starting dose of gonadotrophin will minimize the disadvantages of the treatment and that the stimulation period of the individualized nomogram-based treatment will be 25% shorter than observed in the standard protocol.

The primary endpoint is the proportion of patients who reach the criteria for hCG-administration within 14 days of Menopur stimulation. The results of the study will be compared with the data obtained in the Menopur Ovulation Induction Trial (Platteau et al., 2006).


Eligibility Criteria:
Inclusion Criteria:

1. Anovulatory infertility
2. Age 18 - 39 years
3. Anovulation with oligomenorrhoea (\> 35 days of mean cycle length) or amenorrhoea
4. Normal serum FSH (\< 10 IU/l)
5. Two ovaries
6. BMI \< 35
7. First FSH/HMG cycle at the Fertility clinic.
8. A sperm sample compatible with conception or semen from a donor.
9. Tubal patency documented by either hysterosalpingography (HSG) or hysterosalpingography by ultrasound (HSU) in cases where the woman has had a pelvic infection or pelvic surgery.

Exclusion Criteria:

1. A history of \>12 ovulation induction cycles without achieving pregnancy.
2. More than three earlier gonadotropin cycles at other clinics or earlier treatments with threshold doses below 75.
3. Known hyperprolactinaemia or any other endocrine disturbance or systemic disease of the pituitary gland, thyroid gland, adrenal gland, pancreas, liver or kidney.
4. Undiagnosed vaginal bleeding.
5. Acute or chronic infection with HIV or hepatitis.
6. Persistent ovarian cysts or endometriomas detected by ultrasound.
7. Tumors of the hypothalamus, pituitary gland, breast, adrenal gland or ovary.
8. Pregnancy or lactation.
9. Current or past alcohol or drug abuse.
10. A history of chemo- or radiotherapy.
11. Malformations of reproductive organs incompatible with pregnancy.
12. Hypersensitivity to any trial medication.
Eye Plaque Brachytherapy for Ocular Melanoma

This prospective registry study will evaluate doses utilized in eye plaque brachytherapy for the treatment of ocular melanoma and their associated outcomes. The goal of this study is to evaluate if lower doses of radiation can maintain high local control rates while minimizing the toxicities related to radiation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older with unilateral primary choroidal melanoma
* Patients with diagnosis of small or medium ocular melanomas amenable to plaque brachytherapy (as determined by treating ocular oncologist). Typically this would include tumors with apical height ≤10mm and basal diameter ≤16mm (small and medium tumors per COMS (Collaborative Ocular Melanoma Study)
* Patients with no clinical evidence of metastatic disease as confirmed by negative staging imaging (CT, MRI, and/or ultrasound)
* Patients with best-corrected visual acuity in the fellow eye of 20/200 or better
* Patients must be treated with IsoAid Eye Physics eye plaques

Exclusion Criteria:

* Patients whose tumors are circumferential around the optic disc and cannot be adequately covered by the prescription dose are ineligible.
* Similarly, patients with extrascleral tumor extension detected during echography or clinical exam, diffuse, ring or multifocal tumors that cannot be encompassed in a single episcleral plaque or tumors judged to be predominantly ciliary body or iris melanoma will be considered ineligible
* Previous treatment for ocular melanoma in either eye or treatment of any condition secondary to the tumor are ineligible.
* Patients with a history of other primary or metastatic cancers are not eligible, except for non-melanotic skin cancers
* Patients with extraocular disease