cyrilzakka/clinical-trials huggingface dataset:
Clinical Efficacy of Autologous Mesenchymal Bone Marrow Stem Cells in Active & Progressive Multiple Sclerosis

The purpose of this study is to evaluate the clinical efficacy and the optimal way of administration of autologous mesenchymal bone marrow stem cells (MSC) compering intravenous injection and intrathecal injection vs. placebo, in active-progressive Multiple Sclerosis patients.

Mesenchymal stem cells (MSC) induce immune-modulatory and neurotrophic effects and were shown to have an acceptable safety profile for clinical applications. We aimed to evaluate the safety and efficacy of MSC transplantation in active progressive MS and investigate possible neuroprotective effects.

Methods: This single-center double-blind crossover trial enrolled 48 patients with progressive MS (expanded disability status scale (EDSS) range: 3.5-6.5, mean: 5.6+/-0.8). Patients were randomised into three groups and treated intrathecally (IT) or intravenously (IV) with autologous MSCs (1x106/Kg) or placebo. At 6-months, treatment groups were crossed over and patients re-treated with either MSC or placebo. During the 2-months run-in period and the 12-months after treatment, participants were followed using EDSS, 25-foot timed walking, 9-hole peg test, neurocognitive tests, quantitative magnetic resonance imaging (MRI), functional MRI, optic coherence tomography (OCT), visual evoked potentials (VEP), and dynamic visual tests.

Eligibility Criteria:
Inclusion Criteria:

1. Consenting patients fulfilling the Poser's clinical criteria for definite MS
2. Age: 18-65, males and females
3. Duration of disease: \>3 years
4. Progressive form of MS: PPMS, SPMS (with/without relapses)
5. EDSS score of 3.5 - 6.5
6. Failure to currently available, registered - first and second line immunomodulatory treatments (at least one).
7. Evidence for new activity of MS during the 3 months before the injection of MSC.

Exclusion Criteria:

1. Patients who were treated with cytotoxic medications during the last 3 months prior to the inclusion.
2. Patients suffering from significant cardiac, renal or hepatic failure or any other disease that may risk the patient or interfere with the ability to interpret the results
3. Patients with active infections
4. Patients with severe cognitive decline or inability to understand and sign the informed consent
5. Patients who received any cellular treatment in the past
The Use of a Mitochondrial Enhancement Treatment in Bipolar Disorder

The primary objective of this 15-week clinical trial is to test the hypothesis that treatment with two proven mitochondrial enhancers, acetyl-L-carnitine (ALCAR) and α-lipoic acid (ALA), has significantly greater efficacy than placebo as an augmentation treatment in bipolar depressed patients who display an incomplete response to conventional treatments.

The primary objective of this proposed clinical trial is to test the hypothesis that treatment with two proven mitochondrial enhancers, acetyl-L-carnitine (ALCAR) and α-lipoic acid (ALA), has significantly greater efficacy than placebo as an augmentation treatment in bipolar depressed patients who display an incomplete response to conventional treatments. We propose to test this hypothesis by performing a 15-week placebo-controlled, double-blind, parallel group, flexible-dose study investigating the use of ALCAR and ALA as an augmentation to treatment as usual in depressed bipolar patients. We will compare the efficacy of acetyl-l-carnitine (ALCAR) at doses of 1000-3000mg/day and alpha-lipoic acid (ALA) at doses of 600-1800mg/day with placebo on symptom improvement in individuals diagnosed with bipolar disorder type I, current episode depressed. Improvement will be assessed using the 21-Item Hamilton Depression Rating Scale (HAM-D), the Montgomery Asberg Depression Rating Scale (MADRS), the Young Mania Rating Scale (YMRS), and the Clinical Global Impression-Severity and Improvement Scales (CGI-S and CGI-I).

Furthermore, we hypothesize that improvement in depression symptoms following treatment with ALCAR and ALA will be associated with increases in phosphocreatine (PCr), beta-nucleoside triphosphate (β-NTP), and intracellular pH in the anterior cingulate cortex (ACC) both at week 1 and week 12 of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18-65 years.
* Meets DSM-IV criteria for Bipolar Disorder, type I with current episode depressed.
* Current score of greater than or equal to 18 on the 21-Item Hamilton Depression Rating Scale at Visits 1 and 2.
* Maintained on a stable treatment regimen with no changes in medication dosages for at least two weeks prior to study entry.

Exclusion Criteria:

* Unwilling or unable to provide informed consent
* Score of greater than or equal to 12 on the Young Mania Rating Scale at Visit 1 or 2.
* Current suicidal or homicidal ideation.
* Active psychotic symptoms.
* Lifetime history of schizophrenia or obsessive-compulsive disorder.
* DSM-IV diagnosis of alcohol or substance dependence in the 3 months prior to screening.
* Clinically significant medical condition that would interfere with study participation.
* History of hypersensitivity to ACLCAR or ALA.
* Pregnant or lactating.
The Effect of rTMS in Patients With Spinal Cord Injury (rTMS:Repetetive Transcranial Magnetic Stimulation)

It is postulated that high frequency repetitive transcranial magnetic stimulation (rTMS) can decrease the corticospinal inhibition and enhance the motor recovery. This study is aimed to investigate the effect of high frequency rTMS on lower extremity motor recovery and gait parameters in patients with chronic motor incomplete traumatic spinal cord injury (SCI).

A sham-controlled double-blind randomized study was undertaken. 28 patients with chronic (\>1 year) motor incomplete traumatic SCI were randomized into real rTMS group (n=14) or sham rTMS group (n=14). Real rTMS (20 Hz, a total of 1600 stimuli) or sham r TMS were applied in the motor cortex area of lower extremities during 3 weeks (15 sessions). In addition to rTMS sessions, patients underwent a rehabilitation program including exercises for strengthening, walking and balance. Lower extremity motor score (LEMS), the temporal-spatial gait parameters measured by 3D gait analysis, Walking Index for SCI-II (WISCI-II) scale and 10 meters walking test were assessed at baseline, 3 weeks (after the treatment sessions) and 5 weeks (follow-up).

Eligibility Criteria:
Inclusion Criteria:

* the diagnosis of motor incomplete cervical or thoracic spinal cord injury (ASIA C or D), spinal cord injury due to trauma at least one year previously
* the ability to walk at least 10 meters independently or with assisted devices such as cane / canadian, age (18-45 years). All participants signed the informed consent form.

Exclusion Criteria:

* the presence of other musculoskeletal or neurological diseases that may prevent walking, lower motor neuron lesion (cauda equina and conus medullaris)
* family history of epilepsy
* the presence of brain injury
* the presence of cranium defect
* the presence of pacemaker
* pregnancy
A Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction

An international, multi-centre, double-blind, randomised, placebo-controlled clinical trial with central core lab analyses to determine the safety of intra-coronary infusion of enriched CD133+, bone marrow-derived, autologous progenitor cells in patients 5-10 days after acute percutaneous coronary revascularization (primary PCI) for ST-segment elevation myocardial infarction (STEMI).


Eligibility Criteria:
Inclusion Criteria:

* Primary PCI for acute STEMI between 2-24 hours after onset of chest pain.
* ST-segment elevation \>=2mm in \>=3 adjacent leads.
* Presence of severe hypokinesia and/or akinesia in \>=2 adjacent segments on echocardiogram at 48-72 hrs after primary PCI.
* Age between 20 and 75 years.

Exclusion Criteria:

* Pregnant or lactating.
* Prior history of myocardial infarction before index event.
* Decompensated congestive heart failure.
* Pre-existent LV dysfunction (EF \<45% prior to admission)
* Cardiomyopathy.
* Previous cardiac surgery.
* Congenital heart disorder.
* Serum creatinine \>200 Mmol/L.
* Presence of permanent pacemaker or implantable defibrillator.
* Contraindication to bone marrow aspiration.
* History of malignancy within 5 years except curatively treated basal cell carcinoma, squamous cell carcinoma and/or cervical carcinoma.
* Sustained or inducible VT \>48 hours post primary PCI.
* Three vessel coronary artery disease necessitating intervention within 4 months.
* Immune compromise including chronic human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infection.
* Presence of chronic systemic inflammatory disorders.
* Previous autologous or allogeneic bone marrow or peripheral stem cell transplant or prior solid organ transplantation.
* Low hemoglobin, white blood cell, absolute neutrophil and/or platelet count.
* Any condition associated with a life expectancy of less than 6 months.
* Participation in unrelated research involving investigational pharmacological agent(s) 30 days before planned dosing.
* Current alcohol or drug abuse.
* Inability to provide written informed consent.
Effect of Microvesicles and Exosomes Therapy on β-cell Mass in Type I Diabetes Mellitus (T1DM)

Type 1 diabetes mellitus is strictly autoimmune mediated disease destructing the islets β-cell of the pancreas. Mesenchymal stem cells and its microvesicles are reported as an anti-inflammatory agents. We hypothesis that intravenous infusion of cell free umbilical cord-blood derived MSC microvesicles may reduce the inflammatory state and hence improve the β-cell mass as well as the glycemic control of the patients of T1DM.

* Twenty T1DM patients, age between 18-60 years with reduction of C-peptide chain more than 50%, C-peptide of more than 0.8 ng/mL at Screening and requiring insulin ≥0.4 IU per kg per day.
* Twenty T1DM patients of the same entry selection criteria will be subjected to all steps except the microvesicles administration as a control group.
* Study follow up period: Three months
* Gender: Both males and females are included
* Entry selection criteria include:

UACR less than 300, BUN between 10-20 mg/dl, serum creatinin between 0.6-1.4 mg/dl and normal liver enzymes, normal serum bilirubin, normal serum albumin and coagulation profile). C-peptide of more than 0.8 ng/mL at Screening. BMI 20-40 kgm/m2 - Exclusion criteria: Other autoimmune diseases. Pregnancy. Previous treatment with stem cells. All patients and controls will be investigated for HBV, HCV \& HIV by PCR test before enrollment in the study and positivity for any of these parameters means exclusion of this patient from the study.

- The primary end point will be the end of three months follow up. At day (0):All patients and controls will be subjected to the following investigations: Liver functions tests, kidney functions tests, HbA1c, glucose tolerance test (GTT), fasting and 2 hrs.post prandial blood glucose levels, C-peptide chain level and calculated total daily insulin dose.

After three months (at the end of the study) the same investigations will be repeated.

Two intravenous infusions of cell free cord-blood derived mesenchymal stem cells \[CB-MSC\] microvesicles:

- The first dose will be purified exosomes, ranging between 40-180 nm, in a dose of the supernatant produced from (1.22-1.51) × 10 (6)/kg/IV.

(Characterization of exosomes:CD63, CD9, Alix, TSG 101, HSP 70).

- The second dose, after 7 days, will be the microvesicles, ranging between 180-1000 nm, in a dose of the supernatant produced from (1.22-1.51) × 10 (6)/kg/IV.

(Characterization of microvesicles: (Annexin V, Flotillin-2, selectin,integrin, CD40 metalloproteinase).

Eligibility Criteria:
Inclusion Criteria:

* UACR less than 300, BUN between 10-20 mg/dl, serum creatinin between 0.6-1.4 mg/dl and normal liver enzymes, normal serum bilirubin, normal serum albumin and coagulation profile). C-peptide more than 0.8 ng/mL at Screening. BMI 20-40 kgm/m2.

Exclusion Criteria:

* Other autoimmune diseases. Pregnancy. Previous treatment with stem cells. All patients and controls will be investigated for HBV, HCV \& HIV by PCR test before enrollment in the study and positivity for any of these parameters means exclusion of this patient from the study.
Study Evaluating SC291 in Subjects With r/r B-cell Malignancies (ARDENT)

SC291-101 is a Phase 1 study to evaluate SC291 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.

This is an open-label, single arm, Phase 1, first-in-human (FIH) study to evaluate the safety and tolerability of SC291 administered intravenously (IV) following a standard lymphodepleting chemotherapy regimen of cyclophosphamide and fludarabine in subjects with NHL or CLL who have received two or more prior systemic treatments per standard of care (or after autologous stem cell transplant \[ASCT\] for NHL). This study will be conducted in 2 parts. Phase 1a: dose finding using a 3+3 design in subjects with NHL or CLL. Phase 1b: dose expansion to further evaluate safety and efficacy at the RP2D in subjects with LBCL and CLL.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 18-80 years at the time of signing informed consent.
* Diagnosis of NHL (WHO 2016 criteria) or CLL (iwCLL criteria), including:
* Large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise - - specified (including DLBCL arising from indolent lymphoma), primary mediastinal large -- - B-cell lymphoma, high grade B-cell lymphoma, follicular lymphoma grade 3B
* Follicular lymphoma (dose escalation only except for follicular lymphoma grade 3B)
* Marginal zone lymphoma (dose escalation only)
* Mantle cell lymphoma (dose escalation only)
* CLL or SLL
* Relapsed/refractory disease after at least 2 prior systemic regimens per standard of care or after autologous stem cell transplant
* ECOG performance status of 0 or 1.
* At least one measurable lesion per Lugano Classification (NHL); CLL subjects must meet iwCLL treatment criteria
* Life expectancy ≥12 weeks

Exclusion Criteria:

* Prior anti-CD19 therapy including CD19-directed CAR T treatment or other CD19-directed antibody or cell therapy (e.g., NK cell). (Part 2 dose expansion only - prior approved CD19-directed CAR T therapy required)
* History of primary central nervous system (CNS) lymphoma or presence of CNS metastases
* Systemic anticancer therapy (including platinum-based chemotherapies and I/O therapies) or radiotherapy within 14 days of SC291 (28 days for biologics)
* Autologous HSCT within 6 weeks of treatment with SC291 (or allogeneic HSCT at any time).
* Active autoimmune disease or any other diseases requiring immunosuppressive therapy or corticosteroid therapy (defined as \>20 mg/day prednisone or equivalent).
* History or presence of cardiac or CNS disorders as defined in the protocol
Analysis of Risk in MDS Over Time - Comparison of Treated vs Untreated Patients

A comparison of treated vs untreated patients with MDS with a sample size of approximately 8000 patients in 11 countries.

Non-interventional multicentre retrospective study using chart reviews - study was submitted to the ethics committee of city of Vienna - due to the design of the study no specific approval necessary.

Inclusion of MDS (all subtypes and risk groups) patients according to WHO or oligoblastic AML (RAEB-T according to FAB), untreated and treated during their chronic MDS phase

The 26 centers of the IWG-PM have provided control data set of untreated, all centers will be asked for contribution of treated patients Data will be collected in Austria, Brazil, Czech Republic, France, Germany, Italy, Japan, Netherlands, Spain, UK, USA.

Eligibility Criteria:
Inclusion Criteria:

* MDS (all subtypes and risk groups) according to WHO or oligoblastic AML (RAEB-T according to FAB) patients untreated and treated during their chronic MDS phase

Exclusion Criteria:

* None
Evaluating the Effects of Intermittent Oro-esophageal in Tracheotomy Patients With Neurogenic Dysphagia

Neurogenic dysphagia refers to swallowing disorders caused by the damage of swallowing central or peripheral nerves and muscles. According to statistics, about 50% of patients with neurological diseases will be complicated with neurogenic dysphagia. Common diseases include stroke, dementia, Parkinson's disease and neuromuscular diseases. Dysphagia has a great impact on the quality of life of patients, and is related to malnutrition, aspiration pneumonia and even death. In severe cases, tracheotomy is required to maintain airway patency and discharge secretions. The common nutritional support methods for patients with neurogenic dysphagia after tracheotomy are nasogastric or nasointestinal tube placement and percutaneous gastrostomy.

intermittent oro-esophageal tube feeding (IOE) is a new nutrition method proposed by scholars in recent years. Studies have shown that it can improve the swallowing function of patients with dysphagia while meeting the nutritional needs of patients, so as to effectively improve the quality of life of patients. However, there are few studies on patients with dysphagia after tracheotomy. This study aims to compare the intervention effects of two kinds of tube feeding methods in patients with neurogenic dysphagia after tracheotomy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of neurogenic dysphagia；
* Acute phase has passed, weaning time \> 48 hours, tracheotomy time \>1 week; in accordance with the decannulation process of tracheotomy patients formulated by our center in 2018;
* steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment；
* Gastrointestinal motility is good, can tolerate more than 150ml/h feeding pump speed;
* Willing to sign an informed consent form.

Exclusion Criteria:

* Structural swallowing disorders, such as oral, pharyngeal, larynx, esophagus and other anatomical abnormalities caused by swallowing disorders;
* The clinical condition was unstable, accompanied by heart, lung, brain and other important organ dysfunction;
* Severe cognitive dysfunction, confusion, unable to cooperate.
Effectiveness and Safety of the Nursing Prescription in Acute Health Problems of Low Complexity

Objective: To compare the efficacy/effectiveness of pharmacological nurse prescription with medical prescription in patients attended in a primary care center for minor acute health problems.

Scope of the study: Multicenter study, with the participation of 8 primary care centers of Catalonia.

Methodology: Randomized blind clinical trial, with experimental group receiving pharmacological nurse prescription and a control group receiving medical prescription. Subjects are individuals who request a same day consultation for minor acute pathologies and meet the selection criteria, with random assignment of 374 subjects, 187 per group.

The efficacy/effectiveness of the prescribed treatment will be considered as a no re-attendance during the following 72h and will be completed with the variables: information and knowledge of the treatment, adverse effects, compliance, satisfaction level and resolution of the health problem. The data collection is done 10 days after the visit by an ad-hoc telephone questionnaire of 11 items, previously tested. The analysis is done using the SPSS software version 21.0, obtaining data of descriptive, multivariate and inferential statistics.

Implications for practice: To evidence the equivalence of pharmacological nurse prescription with medical prescription for minor acute health problems


Eligibility Criteria:
Inclusion Criteria:

* Contusion
* Diarrhea / vomit
* Fever without focality
* Flu
* Urinary distress
* Odinophagy
* Toothache
* Skin Bite
* Upper respiratory symptoms
* Ankle twist

Exclusion Criteria:

* Language barrier
* Cognitive deterioration
* Sensory deficit
* Pregnancy
* Immunosuppression
* Neoplasia in the last 5 years
* Does not participate / Does not sign consent
* Breastfeeding period
* Reconsult
* Resides outside of Spain
* Treatment with glucocorticoids in the last 6 months
A Comparison Between the Effects of Conventional Diets vs Intermittent Fasting Diabetic and Pre-diabetic Patients

This research aims to find an effective dietary intervention among the Pakistani population. According to WHO, diabetes is on the rise in developing countries; the current prevalence among the Pakistani population is 11.2% which is expected to increase in the coming years which is in line with the similar documented trend in neighboring south Asian countries.3,11 Since, ethnic south Asians carry a greater risk for developing T2D at a younger age and along with the complications associated with diabetes due to its chronicity, this poses a significant threat and an increased disease burden on the health care system.11

This will be the first trial conducted on determining the efficacy of caloric restriction in a subset of Pakistani population. There is limited inconsistent data on the efficacy of time-restricted feeding, however, this will help elucidate if it does lead to positive effects on the bio-health markers. One of the major hurdles in caloric restriction is patient compliance, therefore, one of the intervention group will be used to determine if TRF with caloric restriction helps improve the patient's compliance and produces significant results. If such an intervention is effective in inducing weight loss it can also be applied for other overweight patients. Eventually, it will help in countering the rising obesity in the region.

The ultimate purpose of the knowledge obtained is to find a patient friendly, novel and therapeutic dietary intervention which will help in limiting the rise in T2D patients. It'll help in introducing an effective lifestyle intervention to promote health, which will reduce the dependence on pharmacological therapies, as well as, in the long-term reduce burden on the health care system.

The information obtained can provide framework for new guidelines in helping the patients to lose weight, which can be utilized by the government to increase general awareness which will help prevent diseases linked to obesity. In light of the randomized controlled trial, the primary health physicians can educate and increase awareness regarding the different dietary interventions the patients can utilize which will help increase the number of options for the patients. Social media platforms can be utilized due to their extended outreach for the transmission of accurate information to the general population.


Eligibility Criteria:
Inclusion Criteria:

* Glycemic values belonging to diabetes or prediabetes category.
* Weight stable for at least 6 months prior to start of study.
* Ability to understand English and use English language mobile applications.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Diabetics taking insulin or sulfonylureas.
* Smokers.
* History of cardiovascular disease.
* History of psychiatric or eating disorders.
* History of hypoglycemic episodes.