cyrilzakka/clinical-trials huggingface dataset:
Non Randomized Comparative Study With Control

NK cells are lymphocytes who play a role in the control of viral infections , tumor and fœtal tolerance. They belong to innate immune cells but they have a link with adaptative immunity. Indeed, after some viral infections such as CMV, Chikungunya, B hepatitis etc, a subset of NKG2C+ NK cells expands and can transfer, in murine models, a " memory " that can better control CMV infections. CMV reactivation is a major cause of morbidity and mortality after allogeneic hematopoietic ste cell transplantation in humans. The aim of this prospective study is to evaluate the role of NK cells, in particular NKG2C+ NK cells in the control of CMV but also Adenovirus after allo HSCT. Peripheral NK cells from 30 and 10 patients who reactivated respectively CMV and AdV are prospectively studied (extensive phenotyping and functional studies before and after administration of anti viral drugs) and compared with 30 allotransplanted patients who didn't reactivate CMV in a pair analysis, and 30 healthy donors serologically + for CMV.

For both groups: 28ml of peripheral blood samples are collected at different points. Group 1 : before and after anti viral treatment . Control group 2: one point after allo-HSCT; Control group 3: 1 point before transplant. Phenotypical study of NK cells: activating and inhibitory receptors, activation and differentiation's markers. Phenotypical studies of the ligands on infected cells. Genotypic study of KIR receptors (Kirotype); functional studies: polyfunctionality essay (flow cytometry): degranulation CD107a, IFNg, TNFa production).

Eligibility Criteria:
Inclusion Criteria:

1. patients who reactivate CMV or AdV after allogeneic HSCT ;

   * Age\>18 years; indication for a antiviral treatment:
   * at least 1 PCR CMV\>1000 copies/ml or 1 PCR ADV\>1000 copies/ml or at least 2 ADV PCR positive - sites (stools, throat, urines);
   * signed informed consent;
2. Control group: allogeneic HSC transplanted patients;

   * Age\>18 years; no CMV or AdV reactivation ;
   * signed informed consent;
3. Healthy donors group: HSC donor;

   * Age\>18 years;
   * signed informed consent

Exclusion Criteria:

none
Vitamin D and Grass Pollen Specific Immunotherapy

Allergen-specific immunotherapy is the only causal therapy of Immunoglobulin E-induced allergies like allergic rhinoconjunctivitis. Despite progress during the last decades it is limited by a long treatment time and high non-responder frequency. Based on experimental and epidemiological evidences we hypothesize that vitamin D can act as an effective immunomodulatory adjuvant to overcome these limitations.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* relative Vitamin D deficiency
* clinical relevant grass pollen allergy
* positive intradermal test with grass pollen
* forced expiratory volume at one second (FEV1) \> 70%

Exclusion Criteria:

* current specific immunotherapy
* instable allergic asthma
* pregnancy and lactation
* treatment with immunomodulators or immunosuppressive drugs
* sarcoidosis, chronic diseases, malignancy
Efficacy of Cervical Epidural Injection and Selective Nerve Root Block

Cervical epidural steroid injections are an accepted treatment modality for radicular pain secondary to disc pathology. With the developing ultrasound technology, ultrasound guided cervical selective nerve root block has been successfully used in the treatment of cervical radiculopathy. We aimed to compare the efficacy of cervical interlaminar epidural injections and cervical selective nerve root block.


Eligibility Criteria:
Inclusion Criteria:

* Cervical radicular pain based on history and physical exam
* NRS pain score \> 3

Exclusion Criteria:

* Previous spine surgery
* Allergic reactions to drugs used in procedure
* Epidural steroid injection within past 2 years
* Radiculopathy not resulting from disc pathology (e.g. foraminal stenosis or tumor)
* Untreated coagulopathy
Compare Electrodry Needlig and Dry Needling in Mechanical Low Back Pain

Mechanical low back pain (LBP) generally results from an acute traumatic event, but it may also be caused by cumulative trauma. The severity of an acute traumatic event varies widely, from twisting one's back to being involved in a motor vehicle collision. Mechanical LBP due to cumulative trauma tends to occur more commonly in the workplace and Quadratus Lumborum injury plays an important role in causing MLBP. The aim of this study is To compare the effects of Electrical Dry Needling and Dry Needling on pain, endurance and range of motion in patients with Quadratus Lumborum Syndrome.

A Randomized Clinical Trial will be conducted at Ali Afzal Shah Dispensary and Inam ul Haq Clinic Lahore through consecutive sampling technique on 40 patients which will be allocated using simple random sampling and patients will be divided in Group A and B. Group A will receive Electrical Dry Needling along with conventional physiotherapy. The parameters for Electro dry needling will be needles of 30×0.25 mm, 50×0.25 mm sizes Frequency 80-100 Hz, Duration 10-30 minutes and intensity as tolerated 1 session per week along with 5 day conventional physiotherapy a week for 4 weeks. Group 2 will receive Dry Needling along with conventional Physiotherapy in which parameters will be dry needles will be 30×0.25 and 50×0.25 mm sizes once per week and 5 days of conventional Physiotherapy per week for 4 weeks. Data will be analyzed during SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Age 25 to 45 years.
* Male and females both included.
* Muscle hypersensitivity on palpation
* Deep aching pain in sides of the lower back.
* Positive side-bridge test (Right \< 83.2 sec and Left \< 81.5 sec)
* Positive Simon's criteria for Quadratus Lumborum
* Patients with NPRS \<7
* ODI score of \< 40
* Decreased Lumber Side flexion and extension ROM
* Positive apperent Leg Length Discrepancy with more than 2 cm
* Negative Laslet's criteria for sacroiliac dysfunction

Exclusion Criteria:

* People with real leg length discrepancy
* People with any other medical condition Including Lumbar fracture, Spondylolisthesis, Ankylosing Spondylysis, Rheumatoid Arthritis. All these conditions will be ruled out with carefully history and examination.
* People taking any other form of treatment including corticosteroids, non-steroidal anti-inflammatory drugs or analgesics.
* People with previous history of surgical treatment for Lumbar spine. o People with neurological deficits or systemic illness
Telehealth-Massed Imaginal Exposure for PTSD

The purpose of this study is to establish the safety, feasibility, and acceptability of very brief imaginal exposure therapy for post-traumatic stress disorder (PTSD) delivered by telehealth over the course of six-daily 60-minute sessions within a 10-day window. All study visits occur remotely, by telehealth. You will be asked to complete a pre-treatment assessment involving a clinical interview, video-based measures of emotional and physical reactions, such as heart rate and breathing rate, and self-report questionnaires to measure the severity and impact of trauma-related symptoms. These assessments are completed again 1-week, and 1-month after completing treatment. The researchers propose that massed exposure-based therapy delivered via telehealth will advance telemental health treatment options and personalized care for Veterans with PTSD.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65.
* Ability to speak, read, and write English.
* Diagnosis of PTSD based on CAPS-5 (\> 3 mo. post-trauma).
* Seeking treatment for PTSD at the Charleston VA.
* Willingness and ability to engage in assessment and treatment visits through VVC, or another VA-approved telehealth videoconferencing platform.

Exclusion Criteria:

* Currently receiving psychotherapy for another anxiety- or stress-related condition.
* Current substance use disorder diagnosis with repeated abuse or dependence within 3 months of study entry and unwillingness to abstain for 24 hours prior to study visits.
* Unstable dose of psychotropic medications within 6 weeks prior to baseline assessment (based on the DMSC; see measures).
* Medical condition that would contraindicate participation in treatment or assessment activities (e.g., severe cardiovascular problems; DMSC, and chart review; see measures).
* Current, or history of bipolar I disorder
* Current, or history of psychotic symptoms
* Serious suicidal risk or a suicide attempt in the past year, as determined by self-report (PHQ-9) and clinical interview (C-SSRS; see measures).
* Active neurological conditions, e.g., seizures, stroke, loss of consciousness or concussion (DMSC, and chart review; see measures)
Myofunctional Therapy in Open Bite - RCT

The goal of this clinical trial is to learn if myofunctional therapy in 6-10-year-old children with infant type of swallowing and open bite is effective.

Primary hypothesis: myofunctional therapy results in correction of open bite Researchers will compare a group in which myofunctional therapy is performed for 6 months to a group in which myoufunctional therapy will be delayed by 1 year.

Participants will exercise according to a pre-established regimen and schedule


Eligibility Criteria:
Inclusion Criteria:

* generally healthy children aged 6-10 years,
* infant swallowing type,
* open anterior occlusion (i.e. no contact between the maxillary and mandibular medial incisors),
* mixed dentition

Exclusion Criteria:

* finger sucking habit (or similar) occurring within the last 6 months,
* previous myofunctional therapy,
* upper airway obstruction,
* congenital craniofacial developmental disorder,
* connective tissue or muscle disease,
* macroglossia,
* ankyloglossia,
* mental retardation
University of California, San Diego (UCSD) Suramin Autism Treatment-1 (SAT1) Trial

This study is designed to test the safety and efficacy of a single, intravenous dose of suramin in autism spectrum disorders (ASD).

This study is designed to test a new theory of the origin and treatment of ASD. In this theory, ASD is caused by both genes and environment interacting to produce a persistent cell danger response (CDR; Naviaux RK, 2014) that interferes with and alters normal child brain development. Gut microbiome and immune systems are also affected. In this theory, the pathological persistence of the cell danger response is traceable to mitochondria, and maintained by purinergic signaling mediated by the release of extracellular nucleotides like adenosine triphosphate (ATP), adenosine diphosphate (ADP), uridine triphosphate (UTP), and uridine diphosphate (UDP). Suramin inhibits excess purinergic signaling by acting as a competitive inhibitor of nucleotide signaling at both ionotropic purinergic (P2X) receptors, and G-protein coupled, metabotropic purinergic (P2Y) receptors. Suramin has been found to correct the symptoms, metabolism, and brain synaptic abnormalities in two classical genetic and environmental mouse models of autism (Naviaux JC, et al. 2015; Naviaux JC, et al. 2014; Naviaux RK, et al. 2013). This study will test the safety and efficacy of a single dose of suramin in children with ASD. While it is not anticipated that a single dose will produce benefits for more than a few weeks, if successful, this study may lead to the development of newer and safer drugs for autism treatment.

Eligibility Criteria:
Inclusion Criteria:

* Autism diagnostic observation schedule (ADOS) score of ≥ 7
* Diagnosis of autism spectrum disorder by Diagnostic and Statistical Manual, 5th edition (DSM-V)
* Stable treatment and diet regimen for ≥ 2 months
* Resident of San Diego region

Exclusion Criteria:

* Any prescription medications
* Hospitalization within the previous 2 months
* Active medical problem such as seizures, heart, liver, kidney, or adrenal disease
* Planning to start a new drug, diet, or behavioral intervention during the study
* Weight under the 5th percentile for age
* Unable to tolerate venipuncture, urine collection, or an indwelling intravenous catheter for 3-4 hours
* Plasma creatinine ≥ 1.4 mg/dl
* Liver function alanine amino transferase (ALT) or aspartate amino transferase (AST) ≥ 1.5-fold above the upper limit of normal
* Known intolerance to suramin or other antipurinergic drugs
* Unable to perform or cooperate with study requirements
a Single HYAJOINT Plus Combined With a Single PPR Versus a Single PRP for Knee OA

Intraarticular hyaluronan or platelet-rich plasma (PRP) is each effective in the treatment for knee osteoarthritis (OA). The efficacy of combined hyaluronan with PRP for knee OA remained unclear. This study aimed to investigate the efficacy of a single intraarticular hyaluronan (HYAJOINT Plus) combined with a single PRP versus a single intraarticular PRP in patients with knee OA.

Intraarticular HA or PRP has been used for knee OA for years. Combined HA and PRP has not been widely used for OA because of lack of clinical evidence. Based on in vitro and animal studies, combining HA and PRP may benefit from their dissimilar biological mechanisms for tissue repair and have potentials to synergistically promote cartilage regeneration, inhibit OA inflammation, modulate the disease process, and improve joint homeostasis in OA. Combination of HA and PRP has much potential for the treatment of OA, but the clinical evidence of this combination remains unclear. The purpose of this study was to investigate the efficacy and safety of combined a single crosslinked HA (HYAJOINT Plus) with a single PRP versus a single PRP alone in patients with knee OA.

Eligibility Criteria:
Inclusion Criteria:

* Aged 20-75 years;Symptomatic knee OA \> 6 months despite conservative treatment such as oral analgesics, NSAIDs and/or physical therapy;Kellgren-Lawrence grades 2 knee OA on radiographs taken within the previous 6 months;Average pain at walking \> 30 mm on a 100-mm visual analog scale (VAS);Radiological evidence of bilateral knee OA was accepted if global pain VAS in the contralateral knee\< 30 mm.

Exclusion Criteria:

* Previous orthopedic surgery on the spine or lower limbs Disabling OA of either hip or foot Knee instability, apparent joint effusion or marked valgus/varus deformity Known allergy to hyaluronan products Women ascertained or suspected pregnancy or lactating Intraarticular injections into the knee in the past 6 months Any specific medical conditions (rheumatoid arthritis, active infections, severe cardiovascular diseases, autoimmune diseases, hemiparesis, neoplasm, etc.) that would interfere with the assessments
Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1805-R1 and NVP-1805-R2

The purpose of this study is to compare the pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-R2

pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-R2

Eligibility Criteria:
Inclusion Criteria:

* Male or female adults aged 19-45 years.
* BMI of \>18.5 kg/㎡ and \<27.0 kg/㎡ subject, weight more than 50kg.
* Voluntarily provided a witten consent to participate in this clinical study.

Exclusion Criteria:

* Treatment with an investigational product (Phase I study or Biological study) within 3month preceeding the first dose of study medication.
* History of (or presence) study medication absortion, distribution, metabolism(e.g., liver/ductal, kidney, cardio-vascular, endocrine, respiratory, GI, hematology, oncology, CNS, musculo-skeletal) or related past medical/surgery history
* Pregnant or lactating women.
Real-World Analysis of Belantamab Mafodotin Care Patterns in Patients With Relapsed and/or Refractory Multiple Myeloma

The purpose of this study is to describe the real-world use of Belantamab Mafodotin - blmf (BLENREP) and associated patterns of care, including dosing and dose modification, eye care specialist visits, associated healthcare utilization, and clinical outcomes in patients with relapsed and/or refractory multiple myeloma (RRMM) seen in the Duke Cancer Institute (DCI) clinics.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years of age as of start of treatment with BLENREP
* Patients with a corresponding diagnosis code consistent with multiple myeloma seen at Duke.
* Patients with a record of starting treatment with BLENREP for RRMM between August 5, 2020 and November 22, 2022.
* Patients having healthcare encounters at Duke Cancer Institute (DCI) for at least 1-month after start of Blenrep treatment.

Exclusion Criteria:

* Patients who were included in any clinical trial for BLENREP including expanded access clinical trials
* Age \> 89 years of age as of start of index therapy
Serum Markers of Ischemia Reperfusion Injury in Liver Transplant Patients

This is an observational study examining serum markers in patients who are undergoing either a cadaveric liver transplant or a living related liver transplant.

The Departments of Anesthesiology are conducting an observational trial of markers in the serum of patients who are undergoing liver transplantation surgery. This study will utilize the biological markers, trimethylamine-N-oxide (TMAO), NGAL, and cystatin-C, sensitive markers of renal medullary injury in the blood and allantoin, a marker of oxidative stress as indicators of renal injury in a kidney during liver transplants. It is hypothesized that: (1) these markers are less pronounced in living donor liver transplant recipient patients than in cadaveric liver transplant recipients, and (2) these markers are less pronounced in cadaveric liver transplant recipients in which a "piggy-back" technique was used versus recipients in which a total venous occlusion technique was used. This study will be done in a multi-center format, along with researchers at UCSF

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Class I-V.
* Patient is undergoing elective Liver Transplant Surgery.
* Patient is an adult, 18 years old or older.

Exclusion Criteria:

* Patients \< 18 Years of Age
* Patients who are pregnant
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Trial to Investigate the Efficacy and Safety of SPM 927 (200mg/Day and 400mg/Day) as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generalization

Male and female patients between 16 and 70 years of age who are diagnosed with epilepsy with partial seizures and are taking up to 3 medications for this medical condition will take part in this research study at approximately 80 different locations in Australia and Europe.

The purpose of this study is to evaluate the effectiveness, safety and tolerability of consistent dosages of study drug (lacosamide) taken orally twice a day for about 4 months.

Each patient who qualifies and chooses to participate in the study will receive placebo (inactive drug) or gradually increasing doses of lacosamide (SPM 927) up to the target dose of 200mg/day or 400mg/day. The target dose or placebo will be maintained for 12 weeks.

The study clinic visits will include a medical history and physical exam, ECG, blood and urine sample collection, and completion of a seizure diary.

Patients who complete the study may enroll in an extension trial and receive active study drug.


Eligibility Criteria:
Inclusion Criteria:

* partial seizures with or without secondary generalization

Exclusion Criteria:

* subjects received SPM 927 in a previous trial
Neurostimulation and Cognitive Intervention in Alzheimer's Disease

This study is a double blind, sham-controlled clinical trial aiming to compare the long-term effects of stimulation in Alzheimer's Disease (AD). Sixty early AD patients will take part in a phase II/III clinical study over a 1-year period. The study involves transcranial direct current stimulation (tDCS), cognitive training (CT), detailed neuropsychological and neurological testing. These assessments will occur at baseline, then again at two month (end point). Those who achieve clinical improvement with neurostimulation and cognitive therapy will be invited to receive treatment for 12 months as part of a follow-up study.

The patients will be randomized into 1 of 4 groups: active tDCS plus real CT, active tDCS plus placebo CT, sham tDCS plus real CT, sham tDCS plus placebo CT. Each group will receive treatment for 30 minutes a day, 3 days a week for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female age 60-90 years
* Patients diagnosed with Alzheimer's Disease, according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) and NINCDS-ADRDA (National Institute for Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association) criteria
* Score between 18 and 26 on the Mini Mental State Examination
* Have a CDR (Clinical Dementia Rating) of 1.0
* If medicated for AD, then use of cholinesterase inhibitors, for at least 3 months and on stable dose for at least 60 days prior to screening.

Exclusion Criteria:

* Pre-existing structural brain abnormalities,
* Other neurologic or psychiatric diagnoses
* Transcranial direct current stimulation criteria: patients with implanted metallic or electronic devices; pacemaker; seizures; pregnancy; any other condition that might limit or interfere in the sensorimotor system
The Total Health Study

This study is a randomized, controlled, multiple risk intervention pilot study evaluated with clients recruited from VA Medical Center Substance Abuse Programs. The intervention combines an innovative online system with interpersonal MI-based coaching delivered in 4 sessions over 12-months time.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria are: at least 18 years of age, enrolled in the San Francisco Veteran Affairs Medical Center (SF VAMC) Substance Abuse Programs, residing in the San Francisco Bay Area and not planning to relocate out of the area in the next 18 months. For patients in the Day Hospital, we will wait until they have completed one week of treatment before approaching for study involvement, as the first week is the most intensive for services.

Exclusion Criteria:

* Exclusion criteria are: unstable psychiatric disorder and severe cognitive impairment.
Assessing Chronic Pain Conditions in General Population

The purpose of this study is to determine the percentage of women, among those attending our institute in order to do Pap test, suffering of chronic pelvic pain. To such purpose the patients will be submitted to questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Women over 18 years of age

Exclusion Criteria:

* unwilling or unable to give consent