cyrilzakka/clinical-trials huggingface dataset:
Stem Cell Educator Therapy in Diabetes

Stem Cell Educator (SCE) therapy circulates a patient's blood through a blood cell separator, briefly cocultures the patient's immune cells with adherent Cord Blood Stem Cells (CB-SCs) in vitro, and returns only the "educated" autologous immune cells to the patient's circulation. Several mechanistic studies with clinical samples and animal models have demonstrated the proof of concept and clinical safety of SCE therapy. They suggest SCE therapy may function via CB-SC induction of immune tolerance in the autoimmune T cells and pathogenic monocytes/macrophages when these are exposed to the autoimmune regulator protein (AIRE) in the CB-SCs. In this project, the optimized SCE therapy for type 1 diabetes (T1D) and T2D will be tested in a prospective, single-arm, open-label, single-center study to assess its clinical efficacy and related molecular mechanisms in patients with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Patients are screened for enrollment in the study if both clinical signs and laboratory tests meet the diagnosis standards of American Diabetes Association.

Exclusion Criteria:

* Exclusion criteria are any clinically significant diseases in liver, kidney, and heart. Additional exclusion criteria are no pregnancy, no immunosuppressive medication, no viral diseases or diseases associated with immunodeficiency.
Does Non-Steroidal Anti-inflammatory Drugs Decrease the Quality of Pleurodesis After Mechanical Pleural Abrasion/Pleurectomy for Treatment of Pneumothorax?

Investigators aim to assess if NSAIDs affect the quality of pleurodesis resulting from mechanical pleurodesis (open surgery or VATS) regarding : Primary outcome: Recurrence of pneumothorax in 6 monthes. (assessed by X ray after 2 weeks and 6 months or symptoms requiring X ray at any timing) Secondary outcome: ▪ Adjusted Length of stay ( from day zero surgery day to discharge ). ▪ Time of removal of the chest Tube .(relatively longer with air leak presence). ▪ Need of opioids (N-SAID may decrease the need of opioids) .

Pneumothorax is a relatively common clinical problem which can occur in individuals of any age. Irrespective of aetiology (primary, or secondary to lung disorders or injury), immediate management depends on the extent of cardiorespiratory impairment, degree of symptoms and size of pneumothorax.Non-steroidal anti-inflammatory drugs (NSAIDs) are being used with increasing frequency, due to their potent analgesic effects without having side-effects on the central neural system and additionally due to the large number and varieties of these agents. The analgesic, antiinflammatory properties, and efficacy of NSAIDs in a wide variety of diseases have been already established . Wound healing and formation of adhesions involve inflammation, cell proliferation, matrix deposition, and neovascularization. The exact mechanism by which NSAIDs affect collagen deposition and the time course of the events leading to the formation of fibrin and of adhesions after pleurodesis have not been completely elucidated until now. NSAIDs can inhibit the inflammatory process and the formation of fibrosis, due to their ability to suppress prostaglandin synthesis .

Eligibility Criteria:
Inclusion Criteria:

* Patients presented with primary or secondary spontaneous pneumothorax
* Age: All age groups are included
* Approach: Open and Video assisted thoracoscopic surgery ( Open and VATS pleurodesis).

Exclusion Criteria:

* Refusal of procedure or participation in the study.
* Patient with any contra indication for NSAID (bleeding tendency , CKD , gastritis , allergy to NSAID ,.....)
Genotypic Influences on Network Progression in Parkinson's Disease

In this longitudinal study, the investigators will follow Parkinson's disease (PD) patients with and without glucocerebrosidase (GBA) mutations. The investigators hypothesize that the rate of increase in brain network activity over time (network progression rate) is faster in patients with GBA gene mutations.

Parkinson's disease (PD) patients with mutations in the glucocerebrosidase gene (GBA) tend to have a more aggressive disease course. GBA may therefore provide a target for disease modifying therapies in mutation carriers. Using positron emission tomography (PET) and magnetic resonance imaging (MRI) brain imaging to measure network progression rates in mutation carriers will allow for the assessment of the potential disease modifying effects of new anti-GBA therapies.

The investigators will also determine whether magnetic resonance imaging (MRI) network methods, which are less invasive and more broadly available than positron emission tomography (PET), produce comparable network progression measurements in individual patients. These determinations will be critical for the design of clinical trials of new disease-modifying drugs.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PD made according to United Kingdom (UK) Parkinson's Disease Society Brain Bank Criteria
* Ability to provide written informed consent
* Age 40-75
* Stable dose of antiparkinsonian medication for \>1 month prior to study entry

Exclusion Criteria:

* Subjects with pathogenic mutations in LRRK2 related PD mutations (subjects with variants of uncertain significance (VUS) are eligible
* History of known causative factors such as encephalitis or neuroleptic treatment
* Patients with dementia (defined as Mini-Mental Status Exam score \<24 or a Telephone Interview for Cognitive Status score \<26)
* Atypical parkinsonian features including oculomotor abnormalities, incontinence, ataxia, sensory loss, or pyramidal signs
* Known structural brain lesions
* Patients with history of stroke, head injury, high intracranial pressure or severe headaches
* Psychiatric disorder, including a history of major depression in the past 36 months
* Pregnant or breastfeeding women (female subjects of child-bearing potential will be screened for pregnancy before imaging).
Proton Beam Therapy for Treatment of Hepatocellular Carcinoma

This study is designed to evaluate the possible benefits and side effects of the use of proton therapy for patients with hepatocellular carcinoma.

Hepatocellular carcinoma (HCC) is a type of primary cancer of the liver that is being diagnosed in the U.S. population with increasing frequency. While surgery is the first line of treatment, many patients are not eligible for surgical removal. Current non-surgical treatments for HCC are not fully effective and can have substantial side-effects. This study utilizes a type of radiation treatment called proton beam that can deliver high doses of radiotherapy to tumors within the liver while minimizing damage to surrounding healthy tissues. The treatment is non-invasive and is given on an out-patient basis over a three week coarse. The study will evaluate the effectiveness and side-effects of this therapy by tracking patient's outcomes following treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hepatocellular carcinoma
* Adult patients aged 18 years old and above
* Ability to give informed consent for study
* Compensated liver disease

Exclusion Criteria:

* Pediatric patients (aged less than 18 years old)
* Decompensated or advanced liver disease
* Poorly controlled ascites
* Variceal hemorrhage within the previous 30 days
* Recurrent hepatic encephalopathy
* Cirrhosis with CTP\* score \>10
* Active alcohol or drug abuse
* Anticipated survival of less than 30 days
* Advanced co-morbid medical illnesses
* Karnofsky Performance Score \<60

Tumor characteristics:

- Any tumor that can not be safely and effectively irradiated due to inability to deliver target treatment dose to required treatment volume or due to prohibitively high risk of anticipated toxicities to normal liver or nearby bowel, stomach, kidney or spinal cord.
Familial B-cell Lymphoproliferative Disorders

This study investigates families with at least two cases of B-cell lymphoproliferative disorders (LPD), and evaluates the prevalence of LPD in families, the relationship between medical history, genetic factors, and the risk of familial LPD, and various clinical outcomes for these families in a multiethnic population of Jews and Arabs in Israel.


Eligibility Criteria:
Inclusion Criteria:

* Patient inclusion criteria:

Patients must have LPD and must have a family history of LPD. LPD patients who signed an informed consent to participate in the study.

Criteria for the inclusion of relatives of patients:

Relatives must be related by blood to LPD patients or unrelated (for control group).

Relatives who signed an informed consent to participate in the study.

Exclusion Criteria:

* Pregnant women, special populations and those lacking judgment will not be included
The Effect of the Use of Artificial Intelligence in the Preparation of Patient Education Material

This research was conducted to examine the effect of students' use of AI tools while preparing patient education material on the quality, understandability and actionability of the material in terms of content. Students in the control group used auxiliary tools such as books, journals and websites while preparing patient education materials. Students in the intervention group used AI tools in addition to tools such as books, journals, and websites.

This research was conducted to examine the effect of students' use of AI tools while preparing patient education material on the quality, understandability and actionability of the material in terms of content. Students in the control group used auxiliary tools such as books, journals and websites while preparing patient education materials. Students in the intervention group used AI tools in addition to tools such as books, journals, and websites. Patient Education Materials Assessment Tool and Global Quality Scale were used to evaluate the educational materials.

Eligibility Criteria:
Inclusion Criteria:

* agreeing to participate in the study,
* taking the Fundamentals of Nursing II course for the first time,
* not working as a nurse in a hospital or any health institution.

Exclusion Criteria:

* not agreeing to participate in the study
* having prepared patient education materials before
* repeating the Fundamentals of Nursing II course
* not having internet access
* not having a computer or smartphone.
Mixture of Liposomal Bupivacaine and Bupivacaine for TAP Block for Open Hysterectomy

The goal of this study is to evaluate the effectiveness of different formulations of bupivacaine infiltrated into the transversus abdominis plane (TAP) on post-operative pain management after open abdominal hysterectomy.

All eligible patients who consent to the study will be randomized to one of three groups. Group 1 will receive a TAP block with 60 mL 0.25% bupivacaine. Group 2 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline. Group 3 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. Patients will be assessed in the post-anesthesia care unit (PACU) at once each on Post-operative day 1,2, and 3.

Eligibility Criteria:
Inclusion Criteria:

* Elective open abdominal hysterectomy with midline incision, age \> 18 years, American Society of Anesthesiologist classification score (ASA classification) 1-3.

Exclusion Criteria:

* Patient with a chronic pain condition, major unexpected surgical complication, unexpected prolonged intubation, patient refusal, local anesthetic allergy, any contraindication to regional anesthesia, greater than 2 attempts by resident and greater than 1 attempt by staff anesthesiologist for TAP block.
Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)

The purpose of this study is to investigate the effects of a fibre mixture added to a high-protein diet on metabolic, gut and brain health.

The fibre mixture that will be investigated is hypothesized to improved metabolic, gut and brain health. It potentially increases insulin sensitivity, satiety, gut barrier function, improves food-reward related brain activity and decreases inflammation, gut permeability, and ectopic lipid accumulation, among other potential health effects.

The fibre mixture will be administrated during 12 weeks combined a high-protein diet. The placebo-controlled parallel design of the study allows for a placebo group to use maltodextrin combined with a high-protein diet for 12 weeks. The high-protein diet is known to increase satiety and might enhance the difference between the intervention and placebo groups in terms of outcome measurements. The potential health effects as described earlier will be investigated using different techniques.

Eligibility Criteria:
Inclusion Criteria:

* Age 30-75 years
* Male/female
* BMI 28-40 kg/m2
* Impaired fasting glucose or glucose tolerance, determined using the following criteria (participant should meet at least one criteria):
* HbA1c 42-47 mmol/mol OR fasting glucose (\>10h fasted) 5.6-6.9 mmol/l OR Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) \>1.85

Exclusion Criteria:

* Diabetes mellitus (type 1 or 2)
* Cardiovascular disease (except hypertension (\<160/100mmHg is allowed), pulmonary disease, kidney disease/failure, liver disease/failure
* Gastrointestinal disease or a history of abdominal surgery (except appendectomy and cholecystectomy)
* Diseases affecting glucose and/or lipid metabolism
* Malignancy (except non-invasive skin cancer)
* Auto-immune disease
* Major mental disorders
* Ongoing (infectious) disease or any disease with a life expectancy ≤5 years
* Substance abuse (nicotine abuse (including e-cigarettes) defined as \>20 cigarettes per day; alcohol abuse defined as ≥8 drinks/week for females and ≥15 drinks/week for males(38); any drugs)
* A change in weight ≥3kg over the last 3 months or plans to lose weight or follow a hypocaloric diet during the study period
* Pre/pro/antibiotic use in the last 3 months or during the study
* Use of medication that influences glucose or fat metabolism and inflammation, such as:

  * Use of statins (stable use ≥3 months prior to and during study is allowed)
  * Use of antidepressants (stable use ≥3 months prior to and during study is allowed)
  * Use of specific anticoagulants
  * Use of medication known to interfere with study outcomes
  * Use of β-blockers
  * Chronic corticosteroid treatment (\>7 consecutive days)
* Regular use of laxatives 3 months prior to the study or during study period
* Change in physical activity or diet during study period
* Intensive physical activity (\>3h per week)
* Pregnancy
* Following a vegan or vegetarian diet; presence of food allergies, intolerances or diet restrictions interfering with the study.
Investigation of Functional Parameters

The goal of this cross-sectional study is to investigate the relationships between grip/pinch strengths, wrist flexion-extension strengths, wrist proprioception, manual dexterity, and bimanual coordination in healthy volunteers. The hypotheses are:

H0: There is no relationship between grip/pinch strengths, wrist flexion-extension strengths, wrist proprioception, manual dexterity, and bimanual coordination.

H1: There is a relationship between grip/pinch strengths, wrist flexion-extension strengths, wrist proprioception, manual dexterity, and bimanual coordination.

Within the scope of the study, the participants' active joint position sense (AJPS) and flexion-extension strengths of the wrist were assessed using an isokinetic dynamometer. Additionally, grip strength, key pinch, tip pinch, and palmar pinch strengths were evaluated using a dynamometer. The Purdue Pegboard Test was used to assess manual dexterity and bimanual coordination.


Eligibility Criteria:
Inclusion Criteria:

After providing detailed information about the research, individuals who agreed to participate were included in the study.

Exclusion Criteria:

Individuals who had undergone surgery or trauma in the upper extremity, had fractures or acute orthopedic injuries, had a history of neuromuscular diseases or congenital anomalies, had skin infections, or other conditions that could affect the assessment within the past 6 months were excluded from the study.
Galantamine Bioequivalence Study of Dr. Reddy's Under Fasting Condition

Galantamine Hydrobromide Tablets, Bioequivalence study of Dr. Reddy's under Fasting condition.

Comparative, Randomized, Single-Dose. 2-way Crossover Bioavailability Study of Dr.Reddy's laboratories, ltd. and Janssen Pharmaceutical Products. L.P. (Reminyte®)4 mg Galantamine HBr Tablets In Healthy Adult Male Volunteers under fasting Conditions

Eligibility Criteria:
Inclusion Criteria:

Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:

* Healthy adult male volunteers, 18-55 years of age;
* Weighing at least 60 kg and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983);
* Medically healthy subjects with clinically normal laboratory profiles. vital signs and ECGs;
* Give voluntary written informed consent to participate in the study.

Exclusion Criteria:

Subject candidates must not be enrolled in the study if they meet any of the following criteria:

* History or presence of significant cardiovascular, pUlmonary, hepatic, renal, hematologic. gastrointestinal, endocrine, immunologic. dermatologic, neurologic, or psychiatric disease.
* In addition, history or presence of:
* alcoholism or drug abuse within the past year;
* hypersensitivity or idiosyncratic reaction to galantamine or other anticholinesterase inhibitors;
* asthma and seizures.
* Subjects who tested positive at screening for HIV, HbsAg or HeV.
* Subjects whose PR interval is \>200 msec at screening and prior to dosing.
* Subjects whose QTc interval is \>450 msec at screening and prior to dosing.
* Subjects who have used any drugs or substances known to be strong inhibitors of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
* Subjects who have used any drugs or substances known to be strong inducers of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
* Subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
* Subjects who, through completion of the study, would have donated in excess of:

  500 mL of blood in 14 days; 1500 mL of blood in 180 days; 2500 ml of blood in 1 year.
* Subjects who have participated in another clinical trial within 28 days prior to the first dose.
Treatment of Soft Tissue Expansion in Inactive Thyroid Eye Disease Patients Using Drops of Prostaglandin Analogues

Prostaglandin analogues eye drops are common and effective treatment for decreasing Intra-Ocular Pressure (IOP) in Glaucoma patients. A number of recently published case reports have documented periorbital fat atrophy following treatment by prostaglandin analogues. In this study the investigators want to use this side-effect of prostaglandin analogues for the treatment of orbital and periocular fat proliferation in inactive Thyroid eye disease (TED) patients, as a conservative substitute for surgical intervention.


Eligibility Criteria:
Inclusion Criteria:

* Inactive TED (Clinical Activity Score below 3)
* Significant exophthalmos or orbital fat expansion.

Exclusion Criteria:

* Previous prostaglandin analogues treatment due to glaucoma
* Known prostaglandin analogues sensitivity.
Clinical Trial for Evaluating Sage-Based Mouthrinse

The investigators aim to evaluate a sage-based mouthrinse (Dr. Hauschka Med, Mundspülung Salbei) whether it is less or equal effective in alleviating inflammatory signs of intra-oral mucosa and gingiva than an water/alcohol-based taste adjusted placebo in patients dependent on ADL.

Randomization in treatment A (mouthwash with active agent, n=24) or treatment B (placebo mouthwash, n=24) Supervised use of mouthwash A or mouthwash B over 6 weeks 1x/day additional to habitual oral hygiene protocol.

The main outcome parameter will be Sulcus Bleeding Index SBI.

A sage-based mouthrinse based on an extract from Salvia officinalis in a composition with extracts from Althaea Officinalis, Aesculus Hippocatanum Bark and essential oils might comprise an alternative to conventional antimicrobial mouthrinses, which might exhibit important side effects. Thus the aim of the current study is to test the null-hypothesis H0:

A sage-based mouthrinse (Dr. Hauschka Med, Mundspülung Salbei, WALA Heilmittel GmbH, Dorfstraße 1, 73087 Bad Boll/Eckwälden, Germany) is less or equal effective in alleviating inflammatory signs of intra-oral mucosa and gingiva than an water/alcohol-based taste adjusted placebo.

The placebo and the sage-based mouthrinse will be manufactured according to EU-Kosmetik-Verordnung 1223/2009 and provided by WALA Heilmittel GmbH, Dorfstraße 1, 73087 Bad Boll/Eckwälden, Germany together with the necessary safety documentation. The placebo will be an alcohol/ water based solution with a similar taste to the tested mouthrinse.

The main outcome parameter will be Sulcus Bleeding Index SBI. Among others, the main secondary outcome parameters will be Oral Health Related Quality of Life as assessed with the OHIP-14 G questionnaire, the Xerostomia inventory and a Tooth staining index.

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent, i.e. no legal guardian appointed
* Willing to participate
* Depended on their ADLs (IADL)(24)
* Sulcus Bleeding Index (SBI) \> 50%

Exclusion Criteria:

* Allergy to one of the components
* Edentulous
* Alcohol dependency
* Prescription of antibiotics and/ or immunosuppressives (e.g. glucocorticoids) Anti-inflammatory mouthrinse -
An Exploratory Study of the Effects of Nivolumab Combined With Ipilimumab in Patients With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to explore the possible links between participant characteristics and their cancer, with how effective the combination of nivolumab with ipilimumab is, in participants with Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, stage IV or recurrent non-small cell lung cancer with no prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease
* Measurable disease by CT or MRI
* Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work

Exclusion Criteria:

* Participants with untreated central nervous system metastases
* Participants with active, known or suspected autoimmune disease
* Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)

Other protocol defined inclusion/exclusion criteria apply