cyrilzakka/clinical-trials huggingface dataset:
TLI, TBI, ATG & Hematopoietic Stem Cell Transplantation and Recipient T Regs Therapy in Living Donor Kidney Transplantation

This study will determine whether a preparatory regimen including total lymphoid irradiation (TLI), total body irradiation (TBI), anti-thymocyte globulin (ATG) and infusion of the donor hematopoietic stem cells when given along with recipient regulatory T cells (Tregs) will allow for eventual discontinuation of anti-rejection drugs after living donor kidney transplantation.

It has been demonstrated that hematopoietic mixed chimerism or the coexistence of both donor and recipient immune cells can lead to tolerance to the graft in absence of graft versus host disease (GVHD). The goal of this pilot study is to determine if recipients of living donor kidney transplant can be successfully withdraw from immunosuppressive drugs. The patients will receive a preparatory regimen consisting of TLI and a low single dose of TBI and ATG following their kidney transplantation. Two weeks later, they will receive purified hematopoietic stem cells (CD34+) and Tcells that have been collected 6 weeks prior from their kidney donor. Regulatory T cells (Tregs) that have been collected from the recipient prior to the transplantation and expanded in vitro will be infuse the following day to enhance the chance of engraftment of the donor bone marrow cells. If chimerism develops and persists, the immunosuppressive drug will be tapered and stop. Mycophenolate mofetil (MMF) will be stopped 12 months after transplantation and if the chimerism remains stable, tacrolimus will be stopped 6 months later. The dose of Tregs will be escalated if the % of donor chimerism is not at least 25% during the first 60 days.

Eligibility Criteria:
Inclusion Criteria:

1. All consenting adults who are 18 to 65 years, living donor renal transplant recipients at Stanford University Medical Center or Northwestern Medicine who have a haplotype matched (minimum single Human Leukocyte Antigen - DR locus (HLA-DR) and HLA-A or B match) living related or unrelated donor.
2. Patients who agree to participate in the study and sign an Informed Consent.
3. Patients who have no known contraindication to administration of rabbit ATG or radiation.
4. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 1 year posttransplant

Exclusion Criteria:

1. Previous treatment with rabbit ATG or a known allergy to rabbit proteins.
2. History of malignancy with the exception of non-melanoma skin malignancies.
3. Pregnant women or nursing mothers.
4. Serological evidence of HIV, Hepatitis B surface antigen positive (HBsAg+), or Hepatitis C infection. Epstein Barr Virus (EBV) positive to EBV negative.
5. Leukopenia (with a white blood cell count \< 3000/mm3) or thrombocytopenia (with a platelet count \< 100,000/mm3).
6. Panel Reactive Antibody (PRA) greater than 80% or demonstration of historic and/or current donor specific antibody (DSA)
7. Prior organ transplantation
8. High risk of primary kidney disease recurrence
9. Advanced coronary or vascular disease.
Measuring Blood Flow in the Brain After Epileptic Activity

In this clinical trial, postictal phenomena (i.e., headache, delirium) will be investigated after administration of acetaminophen and nimodipine in depressed patients receiving electroconvulsive therapy (ECT). Postictal phenomena are thought to result from decreased cerebral blood flow and decreased oxygen concentration in the brain. It is expected that acetaminophen and nimodipine will reduce these postictal phenomena, compared to no treatment, because they target these mechanisms.

Postictal phenomena, such as sensory, motor or memory deficits, headache, delirium, and psychosis, are common manifestations after electroconvulsive therapy (ECT) induced seizures. Also, postictal phenomena add to the burden of seizures in patients with epilepsy. The pathophysiology of these phenomena is poorly understood and effective treatments are not available (Fisher RS, 2000; Krauss \& Theodore, 2010). Recently, seizure-induced postictal vasoconstriction with cerebral hypoperfusion was observed in experimentally induced seizures in rats. Treatment with acetaminophen or calcium antagonists decreased hypoperfusion and postictal phenomena (Farrell, 2016, 2017).

The objective of this research is to study the effect of acetaminophen and nimodipine to reduce postictal phenomena after ECT induced seizures.

A prospective, three conditions crossover trial will be conducted, with randomized condition allocation, open-label treatment, and blinded end-point evaluation (PROBE design; Hansson, Hedner, \& Dahlof, 1992).

Thirty-three adult (age \>17 years) patients referred to treatment with ECT for a depressive episode will be included to achieve a statistical power of .80. This will be feasible in one year.

A single dose of nimodipine (60 mg) or acetaminophen (1000 mg) or no additional treatment will be given prior to a maximum of 12 ECT-sessions per patient. Patients will be randomly assigned to predefined treatment sequences. EEG and MRI measures will serve as main outcome measures, as well as psychometric tests.

Data will be stored on two separate hard disks, one including patient sensitive information for identification, the other with anonymized data only (for the sponsor).

Patients will be recruited by doctors at Rijnstate Hospital Arnhem. A mixed model with repeated measurements analysis will be conducted for the primary outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Adulthood (age \> 17 years);
* Current clinical diagnosis of depressive episode (unipolar, bipolar, schizoaffective);
* Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements.

Exclusion Criteria:

* Known adverse or allergic reactions to acetaminophen or nimodipine;
* Chronic use of acetaminophen, calcium-antagonists or NSAID's that cannot be interrupted for less than two days before the ECT-session;
Comparison of the Effect of Hydrophobic Acrylic and Silicone 3-piece IOLs on Posterior Capsule Opacification

Age-related cataract is the main cause of impaired vision in the elderly population worldwide.

The only treatment that can restore functional visual ability is cataract surgery where the opacified crystalline lens is removed by phacoemulsification and an artificial intraocular lens is implanted into the remaining capsular bag. Cataract operations are generally very successful, with a low risk of serious complications.

The most common reason for impaired vision after uneventful cataract surgery in otherwise healthy eyes is the development of posterior capsule opacification (PCO). PCO is a physiological change (thickening, opacification and clouding) of the capsular bag expected after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure that uses a laser to open a central hole in the posterior capsular bag.

Modifications in IOL design and material lead to a decrease in the incidence of PCO.

During the past two decades, refinements in surgical technique were made resulting in today's small incision phacoemulsification surgery. Nowadays a multitude of microincision IOLs are available, many of them similar but of course with some differences in regard to the chemical composition of the acrylic material and the IOL design.

The purpose of this study is to compare the development of posterior capsule opacification (PCO) and the frequency of treatment between two different microincision IOLs over a period of 2 years.


Eligibility Criteria:
Inclusion Criteria:

* bilateral age-related cataract
* good overall physical constitution

Exclusion Criteria:

* previous intraocular surgery or ocular trauma
* intraocular complication like posterior capsular tear
* glaucoma
* uveitis
* corneal diseases, diabetic retinopathy and any other severe retinal -pathology that would make a postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better unlikely
Single and Multiple-Ascending Dose Study of CRN00808 in Healthy Volunteers

This single-center study will be conducted in 3 phases: a single-ascending dose phase (up to 8 cohorts, 8 subjects/cohort), a multiple-dose phase (up to 5 cohorts, 9 subjects/cohort), and a midazolam drug-drug interaction phase (one cohort of 8 subjects).

The single-dose phase initiates with ascending doses of an oral solution followed by a 3-way crossover food effect and bioavailability (capsule formulation) cohort. Serum IGF-1 levels and GHRH-analog stimulated GH levels will be assessed as pharmacodynamics measures.

The first multiple-dose (7 days dosing) cohort will be initiated after the PK and safety data are available from the single-dose phase. Subsequent multiple-dose cohorts will have 10 days of dosing. Serum IGF-1 level and GH levels will be assessed as pharmacodynamics measures.

The last cohort in the study is midazolam drug-drug interaction study. The dose will be selected based on review of all pharmacokinetic and safety data for the single-dose and multiple-dose cohorts completed. On Day 1, 8 subjects will receive a single oral 2 mg dose of midazolam. Starting on Day 3 through Day 8, subjects will receive daily doses of CRN00808. On Day 9, subjects will be administered CRN00808 and 2 mg midazolam together.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18 to 30 kg/m2
* Females postmenopausal or surgically sterile

Exclusion Criteria:

* Any uncontrolled or active major systemic disease including, but not limited to: acromegaly (with or without pituitary surgery or radiation therapy), cardiac, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential
* History or presence of malignancy within the past 5 years. Subjects who have been successfully treated (for 3 months or longer) with no recurrence of basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled.
* Use of any investigational drug within the past 60 days or 5 half-lives, whichever is longer
* Have a medically significant abnormality observed during screening or the admission physical examination or in any other baseline measurements
* Use of any prior medication without approval of the investigator within 14 days prior to admission
* Tested positive at screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab) or has a history of a positive result
* History of alcohol or substance abuse in the past 6 months
* Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this Phase 1 study
A Study Into Pain Relief Given by ASP8477 for Peripheral Neuropathic Pain (Either Post-herpetic Neuralgia or Painful Diabetic Peripheral Neuropathy) and Its Safety

The purpose of this study is to assess the painkilling efficacy of ASP8477 relative to mock (placebo) in patients that have been diagnosed with painful diabetic peripheral neuropathy or postherpetic neuralgia determined by the change in the average daily pain intensity in patients that initially respond favorably to treatment with ASP8477.

The study will consist of a Screening Period, Single-Blind Treatment Period, Double-Blind Randomized Withdrawal Period and Follow-up Period.

Eligibility Criteria:
Inclusion Criteria:

* PDPN subject must have:

  * Established diagnosis of diabetes (type I or II) with painful diabetic peripheral neuropathy and glycosylated hemoglobin (HbA1c) ≤ 11% at Screening.
  * Stable glycemic control (HbA1c ≤ 11%) achieved by a drug regimen for at least 3 months prior to Screening.
  * At least a 1-year history of DPN pain.
  * Diabetic distal symmetrical polyneuropathy symptoms (including pain) stable for at least the last 3 months prior to Screening based on PI judgment and subject-reported medical history.
* PHN subject must have pain present ≥ 6 months after healing of the herpes zoster rash.

Exclusion Criteria:

* Subject has significant pain of an etiology other than PDPN or PHN, or clearly non differentiated pain, or plantar fasciitis, heel spurs, tibial neuropathy, Morton's neuroma, bunions, metatarsalgia, arthritis in feet, ischemic pain, neurological disorders unrelated to diabetic neuropathy, skin condition in area of neuropathy that could alter sensation, malignancy, or current orthostatic hypotension, hypo or hypertension, syncope or clinically significant ECG, clinical intolerance to Non-steroidal anti-inflammatory drugs (NSAIDs) or ASP8477, depression, psychosis or psychiatric or neurological illness, BMI of over 35, renal impairment or failure, alcohol (ETOH) or drug abuse, GI complaints.
* Previous investigational therapy within 28 days or 5 half lives
Efficacy and Safety Evaluation of AN2690 Topical Solution to Treat Onychomycosis of the Toenail

The purpose of this study is to determine whether AN2690 topical solution is a safe and effective treatment for onychomycosis of the toenail.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of distal subungual onychomycosis affecting at least one great toenail
* KOH positive at screening
* Willingness not to use any other products including nail polish applied to the toenails during the study
* Women of childbearing potential who are currently sexually active must agree to use contraception for the entire study period

Exclusion Criteria:

* Concurrent or recent use of certain topical or systemic medications without a sufficient washout period
* History of any significant chronic fungal disease other than onychomycosis
* Significant confounding conditions as assessed by study doctor
* Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
* Pregnancy or lactation
The Validity and Reliability of the Turkish Version of TASC and the Relationship Between SMC and Motor Functions

Selective motor control (SMC) impairment in children with cerebral palsy (CP) includes movement patterns dominated by flexor or extensor synergy affecting functional movements. The research was designed to investigate the validity and the reliability of the Turkish version of the Test of Arm Selective Control (TASC) (which is improved to evaluate SMC in children with spastic CP) and in order to provide more understanding of the relationship between SMC and upper extremity and gross motor functions. The study included 21 hemiplegic, 11 diplegic and 4 quadriplegic children with CP whose ages are 4 to 18 years and Gross Motor Function Classification System (GMFCS) level changes from 1 to 4, and their parents. In order to evaluate the gross motor function of children, GMFCS and the ability to hold objects with their hands in daily activities were evaluated with Manual Ability Classification System (MACS). ABILHAND-Kids scale was applied to evaluate upper extremity performance. TASC scale was used to evaluate the upper extremity SMC of children.


Eligibility Criteria:
Inclusion Criteria:

* having a diagnosis of spastic CP
* being able to understand the commands required for the test,
* being between the ages of 3-18,
* being GMFCS level I to IV.

Exclusion Criteria: • Having undergone orthopedic surgery or Botulinum Toxin A (BTX-A) within the last 6 months
Clinical Performance and Stability of Different Types of Implant Supported Overdenture

A Total number of 36 implants were installed in 6 patients having mandibular single denture.

The patients were divided into two groups according to the definitive prosthesis.

Group I received ball and socket retained mandibular implant overdenture while Group II received cement retained implant supported fixed bridges.

Implant's stability, clinical performance (gingival index, pocket depth, plaque index and bleeding on probing) and patient's satisfaction were performed after 15, 30,60 and 90 days after prosthesis delivery

Eligibility Criteria:
Inclusion Criteria:

* highly co-operative
* non-smoker
* systemically free from any chronic diseases

Exclusion Criteria:

* immunocompromised patients
* patients having knife edge, flat or flabby ridge,
* patients having T. M. J disorders
Motor Rehabilitation and Physical, Mental and Cognitive Health in Patients With Stroke

This study analyzes the effectiveness of a motor rehabilitation program in the functional recovery of stroke patients and its impact physiotherapy, occupational therapy, and neuropsychology are used to measure improvements in balance, mobility, independence in daily activities, and cognitive functions. The intervention involves the use of the Lokomat, a technologically advanced robot-assisted gait training device. Patients are supported in a harness on a treadmill while the robotic system guides their legs through a natural gait cycle. The results will help clarify the relationship between motor recovery and overall well-being, providing evidence to optimize therapeutic strategies for stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of ischemic or hemorrhagic stroke.
* Age equal to or greater than 18 years.
* Patients in the subacute or chronic phase of stroke (≥ 3 months since the event).
* Ability to participate in a motor rehabilitation program.
* Absence of advanced neurodegenerative diseases that may interfere with the evaluation of results.
* Ability to understand and follow basic instructions of the rehabilitation program.
* Informed consent signed by the patient or his/her legal representative.

Exclusion Criteria:

* People under 60 years of age.
* Presence of serious comorbidities that prevent physical activity or rehabilitation (e.g. severe heart failure, advanced chronic obstructive pulmonary disease).
* Patients with severe cognitive impairments that make it difficult to follow the program (e.g. advanced dementia).
* Use of drugs that significantly affect motor and cognitive function, interfering with the evaluation of rehabilitation.
* Presence of active infections or unstable medical conditions requiring hospitalization.
* History of another neurological disorder that may affect functional recovery (e.g. Parkinson's disease, multiple sclerosis).
* Participation in another rehabilitation program at the same time, which may interfere with the results of the study.
Amoxicillin Susceptibility of Oral Streptococci After a 3-Day or a 7-Day Amoxicillin Therapy

Antibiotic resistance is a worldwide problem closely linked to antibiotic consumption. To limit the risk to select resistant bacteria, the rules of prescription are to use high doses and short durations of treatment. The purpose of this study was to evaluate the interest to reduce amoxicillin treatment from 7 days to 3 days, in cases of odontogenic infection requiring the extraction of the tooth associated with amoxicillin monotherapy. The 3-day treatment will be compared to the classical 7-day treatment for clinical efficacy (pain, wound healing) and impact on the susceptibility of oral streptococci to amoxicillin.

Amoxicillin treatment starts the day of the inclusion in the study (day 0). Dentists and participants were blinded to treatment assignment for the duration of the study. The infected tooth was extracted 2 days after the beginning of the antibiotic treatment, and the post-operative follow-up was done 1 week after tooth extraction (day 9). An additional follow-up was done one month later (day 30).

Clinical parameters were collected one week after tooth extraction (day 9). Pain was evaluated by its intensity during the days following surgery (using an analog visual scale varying from 0 -no pain- to 10 -very intense pain-), and by the total amount (in mg) of paracetamol ingested. The infectious state was evaluated by local wound healing, regional adenopathy and fever. The wound healing score combined local inflammation and sensitivity, and the presence or absence of a blood clot.

The streptococci resistance was assessed at the patient-level by the proportion of patient with at least one resistant streptococcus, and at the streptococcus-level by the proportion of resistant streptococcus out of the total streptococci flora. Intermediate susceptibility to amoxicillin was defined as a minimum inhibitory concentration (MIC) of 0.5-16 mg/L; resistance was defined as an MIC greater than or equal to 16 mg/L.

Eligibility Criteria:
Inclusion Criteria:

* odontogenic infection requiring tooth extraction asociated with amoxicillin monotherapy
* good condition
* 18-60 years old
* written informed consent provided

Exclusion Criteria:

* antibiotic prophylactic treatment
* special infectious risk (immunodeficiency, diabetes..)
* pregnant or breastfeeding women
* amoxicillin contraindication
* antibiotic treatment during the lasts 45 days
A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject

This is a study to show that vaccination with three doses of Quinvaxem presented in Uniject is not inferior to vaccination with three doses of Quinvaxem presented in single dose vials, with respect to protection against all antibodies (anti-hepatitis B surface antibodies, anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and anti-Bordetella pertussis) one (1) month after completion of the 6-10-14 week vaccination course.


Eligibility Criteria:
Inclusion Criteria:

* A male or female between, and including, 42 and 64 days of age at the time of the first vaccination
* Written informed consent obtained from parents/legal guardians of the subject
* Free of obvious health problems as established by medical history and/or clinical examination before entering the study
* HepB vaccination at birth (within 48 hours)
* Available for all scheduled study visits

Exclusion Criteria:

* Use of any investigational drug or any investigational vaccine in the 30 days preceding the first dose of study vaccine, or their planned use during the study period and safety follow-up
* Planned administration of a vaccine not foreseen by the Study Protocol
* Known or suspected impairment of immune function, known HIV-positivity; actively receiving immunosuppressive therapy, or in receipt of systemic immunosuppressive therapy in the one month prior to study entry (note: inhaled and topical steroids are allowed)
* Administration of parenteral immunoglobulin preparation and/or blood products since birth
* Previous vaccination against Hib and/or DTP
* History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity to any vaccine component or to products containing mercury compounds, such as thiomersal
* Clinically significant acute infection
* Clinically significant acute illness
* Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives
* Participation in another clinical study