cyrilzakka/clinical-trials huggingface dataset:
Osteopathic Single CAse Research for Patients With Chronic Low Back Pain

This study aims to collect primary data from patients with low back pain to assess the effect of standard osteopathic management and biopsychosocially-informed osteopathic care using a Single-Case Experimental Design.

After being informed about the study and potential risks, all osteopaths and patient participants giving written consent will be screened for eligibility. When entering the trial, patients will be randomised to early, intermediate or late intervention with either standard osteopathic management or biopsychosocially-informed osteopathic management.

Eligibility Criteria:
Inclusion Criteria:

* 18 or more years old
* agree to take part in the study and provide formal online consent after having been assessed as capable of providing informed consent by the osteopath
* Being fluent enough in English to be able to understand content of consent forms (and participate in osteopathic treatment without an interpreter)
* Presenting with non-specific low back pain of a duration of a minimum of 12 weeks)
* NRS score between 5 and 9 on a 11-point scale
* PSFS score between 2 and 7 at baseline
* Who can be contacted by email
* Available for an appointment within two days around the randomisation date

Exclusion Criteria:

* Under 18
* Lacking capacity to give consent
* Presenting with low back pain with a known or suspected pathological cause (e.g. infection, cancer or fracture)
* People for whom osteopathic treatment may be contra-indicated (as assessed by the osteopath in the initial consultation) or who disclose information during their course of treatment which requires referral for other medical investigations or care
* LBP of less than 12 weeks
* NRS score below 5 or above 9
* PSFS score above below 2 or above 7
* Patients providing less than 3 data points during baseline
SPI-1005 in Adults Receiving Cochlear Implant

The goal of this clinical trial is to learn about the effects of drug SPI-1005 in adults receiving a cochlear implant with a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.

The main question this clinical trial aims to answer is: Is drug SPI-1005 safe and well-tolerated in adults receiving a cochlear implant, and/or what medical problems might participants experience when taking drug SPI-1005?

The clinical trial will also measure the effects of SPI-1005 on hearing, word recognition, speech discrimination, tinnitus, and vertigo outcomes after receiving a cochlear implant. The purpose for this and future clinical trials is to learn whether SPI-1005 can prevent or treat these side effects after receiving a cochlear implant.

Participants will take drug SPI-1005 or placebo (a look-alike substance that contains no drug) for 6 months, starting 2 days before receiving the cochlear implant. There are 5 required in-clinic visits over 6 months for audiology and other tests.

The effects of SPI-1005 will be compared to the placebo (the look-alike substance that contains no drug) to study what effects SPI-1005 might have.


Eligibility Criteria:
Inclusion Criteria:

* Adults who are ≥18 years of age at time of consent.
* Post-lingual, bilateral, severe to profound sensorineural hearing loss scheduled to receive a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.
* Air conduction thresholds (decibel hearing loss, dB HL) at baseline in the ear scheduled to receive the cochlear implant:

  * ≥40 and ≤70 dB HL at 125, 250, and 500 Hz; AND
  * ≥80 dB HL at 2000 through 8000 Hz.
* Willing and able to provide informed consent and to perform all behavioral tests as specified per-protocol, including pre-specified reproductive requirements.

Exclusion Criteria:

* Current, or within 60 days prior to study enrollment, use of IV ototoxic medications such as chemotherapy including cisplatin, carboplatin, or oxaliplatin; aminoglycoside antibiotics including gentamicin, amikacin, tobramycin, kanamycin, or streptomycin; or loop diuretics including furosemide.
* Participation in another investigational drug or device study within 90 days prior to study enrollment.
* Female patients who are pregnant or breastfeeding.
* Air conduction thresholds at baseline in the ear scheduled to receive the cochlear implant with any No Response at 125 through 8000 Hz.
Prevenar13 Post Market Surveillance

It is an observational multi-center study to assess the safety profile of Prevenar13 used among Korean children in the routine clinical setting following a licensure and introduction of the vaccine. This study is designed to fulfill regulatory requirement for any new drug authorized by KFDA.

non-randomization, non-probability sampling

Eligibility Criteria:
Inclusion Criteria:

* Infants and children aged 6 weeks to 5 years, whose legally authorized representatives of patients agree to provide written informed consent form (data privacy statement).

Exclusion Criteria:

* Infants and children who are not indicated and/or contraindicated for the Prevenar13 usage will not be included.
Obstetrics and Periodontal Therapy (OPT) Study

The purpose of this study is to determine if non-surgical periodontal (gum) treatment can reduce the incidence of preterm birth and low birth weight babies in mothers with periodontitis (gum disease).

Eight hundred sixteen women who are between 13 and 16 weeks pregnant will be enrolled in this trial. Volunteers will be recruited from Hennepin County Medical Center (MN), the Jackson Medical Mall (MS), the University of Kentucky, and Harlem (NY) Hospital. The incidence of preterm birth is higher at these sites than the national average. Subjects will be randomly assigned to receive non-surgical mechanical periodontal therapy (scaling and root planing) either prior to 20 weeks of their pregnancy or soon after delivery. All subjects will be monitored for progressive periodontitis and will be treated immediately regardless of their group assignment. All women will also receive essential dental care to restore caries and treat abscessed teeth. The primary birth outcome is gestational age at birth and the secondary outcome is birthweight. Maternal risk factors for preterm birth and/or intrauterine growth restriction will be used as covariates in the data analysis. The study will also document the effect of periodontal therapy on immune response, systemic markers of inflammation, periodontal infection and clinical periodontal measure.

Eligibility Criteria:
Inclusion

* Be pregnant in the first 13-16 weeks of gestation as determined by menstrual history and obstetrical ultrasound
* Be at least 16 years of age
* Have at least 20 natural teeth,
* Have bleeding on probing (BOP) on at least 35% of all tooth sites
* Have 4 or more teeth with pockets greater than or equal to 4 mm and attachment loss greater than or equal to 2 mm

Exclusion

* Are unable to provide informed consent or are unable to cooperate with the study protocol.
* May be placed at medical risk as a result of participation (i.e. subjects with hematologic disease or other disorders tha preclude routine non-surgical periodontal therapy).
* Have multiple fetuses as diagnosed by ultrasound.
* Require antibiotic prophylaxis for periodontal procedures
* Require greater than 3 essential dental care visits because of extensive decay and/or broken teeth and are likely to have less than 20 natural teeth following essential dental care
A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies

This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX112™ in subjects with relapsed or refractory B-cell malignancies.

This is an open-label, multi-center Phase 1/2 study of CTX112 in subjects with relapsed/refractory B cell malignancies. CTX112 is an is allogeneic CD19-directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells that are genetically modified ex vivo using CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats/ CRISPR associated protein 9) gene editing components (single guide RNA and Cas9 nuclease).

Eligibility Criteria:
Key Inclusion Criteria:

1. Age ≥18 years.
2. Refractory or relapsed B cell malignancy.
3. Eastern Cooperative Oncology Group performance status 0 or 1.
4. Adequate renal, liver, cardiac and pulmonary organ function.
5. Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX112 infusion.

Key Exclusion Criteria:

1. Prior allogeneic hematopoietic stem cell transplant (HSCT).
2. Active or history of central nervous system (CNS) involvement by malignancy.
3. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
4. Presence of bacterial, viral, or fungal infection that is uncontrolled or requires IV anti-infectives.
5. Active HIV, hepatitis B virus or hepatitis C virus infection.
6. Previous or concurrent malignancy in the last 3 years (with the exception of non-melanoma skin cancer and other cancers deemed by the investigator and medical monitor to be of low likelihood for recurrence).
7. Concurrent systemic treatment with an anticancer biologic (e.g., monoclonal antibody) within 30 days prior to CTX112 infusion or with a nonbiological anticancer drug within 14 days prior to CTX112 infusion.
8. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
9. Women who are pregnant or breastfeeding.
Analysis of miRNAs Expression in Vasoplegic Syndrome After On-pump Coronary Artery Bypass Surgery

This study looks for a correlation between microRNAs (miRNAs) and vasoplegic syndrome after on-pump coronary artery bypass surgery.

Cardiovascular diseases (CVD) are among the main causes of morbidity and mortality in the world, and in Brazil they account for approximately 31% of all causes of death and 42% of deaths due to noncommunicable diseases. In 2014 were carried out a total number of 92,000 heart surgeries in Brazil and these are usually performed using Cardiopulmonary Bypass (CPB), which is made by the diversion of blood circulation of the lungs and heart to a heart-lung machine, which keeps cardio circulatory functions and oxygenates the blood. Despite enable various types of major cardiac surgery, the use of CPB can cause serious side effects such as post perfusion vasoplegic syndrome (VS). This is characterized by increased cardiac output, hypotension, systemic inflammatory response and decreased vascular resistance, affecting 9-44% of patients in the postoperative period of cardiac surgery, with a mortality of 27%. Treatment to VS are limited and the drugs are often ineffective, including noradrenaline, vasopressin, and methylene blue. Another difficulty encountered by the surgeon is to establish a predictive factor for VS. Systems risk predictors that use score and are well validated as EuroSCORE (European System for Cardiac Operative Risk Evaluation) have not been tested for VS. Much has been studied on the use of biomarkers as predictors and for prognosis as well as to improve predictive power of the rating systems available. MicroRNAs (miRNAs) are noncoding RNA molecules that control gene expression in the intracellular environment and are present circulating in various body fluids including peripheral blood. These molecules can be used as biomarkers of various pathologies including CVD. Despite the existence of numerous studies that demonstrate the importance of miRNAs in the development of CVDs. There are no studies that address the issue in VS. Therefore, the objective of the project is to identify the presence of blood miRNAs that are altered in patients with pre and intra-operative cardiovascular surgery and assess whether these miRNAs can be used as predictors and biomarkers of mortality for VS.

Eligibility Criteria:
Inclusion Criteria:

* Patients who go to coronary artery by-pass , on-pump surgery
* Patients who sign an informed consent
* Only elective or urgency surgery

Exclusion Criteria:

* off-pump surgery
* emergency surgery
* previous use of vasoactive drugs or Intra aortic balloon
* Patients with active acute coronary syndrome
* Acute mesenteric ischemia, Reynaud disease, neoplasia and Pregnancy
The Pharmacokinetics of a Single Large Dose of Vitamin D3

When people eat a meal, some, but not all of the calcium in that meal is absorbed, that is, moved into the bloodstream. When the skin is exposed to sunlight during summer months, Vitamin D is made there and then modified into more active forms by the liver and kidneys. These more active forms of Vitamin D improve calcium absorption. Many adults living in the U.S. have little or no sun exposure and are low in Vitamin D. A single dose of 100,000 IU of Vitamin D3 has been used both as empiric treatment for Vitamin D deficiency as well as in controlled trials without risk of raising blood calcium to dangerous levels.This study is to determine the serum levels of Vitamin D and 25-hydroxyvitamin D (vitamin D after it has been modified by the liver) that can be expected when Vitamin D3 is given as a single oral dose of 100,000 IU.

The group receiving the supplement will be scheduled for short visits to our research center at baseline and days 1,3,5,7 and then weekly for 3 weeks and then every other week for 6 visits (total 14 visits in 4 months). The group not receiving supplement will be scheduled for short visits at baseline and in 4 months. At the beginning of the study we will measure your height, weight, skin color, and draw blood to measure your blood levels of Vitamin D, 25-hydroxyvitamin D, calcium and parathyroid hormone. At each visit we will draw blood to measure your blood levels of Vitamin D and 25-hydroxyvitamin D. There will be fourteen blood draws for a total of 280 cc of blood drawn (about 4 teaspoons drawn each time) in the supplemented group. There will be 2 blood draws in the group not receiving supplements for a total of 60 cc of blood drawn (about 4 teaspoons drawn each time).

Eligibility Criteria:
Inclusion Criteria:

* healthy with limited sun exposure of less than 10 hours per week and daily milk consumption of less than 0.47 L (16 oz.).

Exclusion Criteria:

* those with granulomatous conditions, liver disease, kidney disease, or diabetes and those taking anticonvulsants, barbiturates, or steroids in any form.
Examining Mu Opioid Mechanisms of Ketamine's Rapid Effects in OCD (MKET2)

The purpose of this study is to understand how ketamine works in the brain to bring about a reduction in OCD symptoms.

The proposed mechanistic trial would be the first to probe the role of ketamine's opioid properties in modulating fronto-striatal circuitry and bringing about reduction of OCD symptoms.

Eligibility Criteria:
Eligibility Criteria for Participants with OCD:

Inclusion Criteria:

* Ages 18-65
* Meet the criteria for OCD diagnosis
* Failed at least 1 prior trial of standard first-line OCD treatment
* Agree to the following lifestyle modifications: comply with requirements for fasting prior to the Experimental Session, not enroll in any other interventional clinical trials during the duration of the study, and commit to medication study procedures.
* Able to provide informed consent

Exclusion Criteria:

* prior naltrexone or ketamine use/exposure
* Any current or past medical/psychiatric condition that makes participation unsafe in the opinion of the investigator or study physician
* Pregnant or nursing, or able to become pregnant and are not practicing an effective means of birth control
* the presence of metal in the body that is contraindicated for MRI scans

Eligibility Criteria for Healthy Volunteers:

Inclusion Criteria:

* Ages 18-65
* Able to provide informed consent

Exclusion Criteria:

* current or past use of psychotropic medication
* pregnant or nursing females
* the presence of metal in the body that is contraindicated for MRI scans
A Study to Evaluate the Efficacy of Microlyte Matrix in the Management of Donor Site Wounds

A study to to evaluate the efficacy of Microlyte® Matrix by demonstrating its superiority to the standard of care in the healing of donor site wounds in patients requiring split-thickness grafting, as well as to assess the occurrence of donor site wound infection, allergic reaction, pain and itching, and scarring at 12 weeks, assessed by patients using the Patient and Observer Scar Assessment Scale (POSAS).

The proposed study is a randomized, controlled, open-label clinical trial to assess the efficacy in wound healing of the FDA 510k cleared Microlyte® Matrix (K153756) in surgically created partial thickness donor site wounds \> 100 cm2 in size on patients and harvested at 12/1000th inch requiring split-thickness skin grafting. Subjects are expected to be hospitalized as in-patients for approximately 7 days following initial donor site surgery. Study visits conducted after hospital discharge must be conducted as out-patient clinic visits.

Each wound will be divided into proximal and distal halves with one half randomized to receive Microlyte® Matrix. Kaltostat/Tegaderm will be used as the control. Thus, each patient is their own control removing the potential variability of the depth of donor site wounds between patients as a confounding factor.

Microlyte® Matrix is a FDA-cleared (K153756) antimicrobial dressing manufactured by Imbed Biosciences, Inc. (Madison, WI), which is an ISO 13485 certified/FDA QSR compliant facility. It is indicated for the management of partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic foot ulcers, first and second-degree burns, abrasions and lacerations, donor sites and surgical wounds.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients where creation of a donor site wound for any indication including chronic wound, burn wound, surgical/traumatic wound, and tumor excision.
2. Donor site wound with a surface area of greater than 100 cm2 is required.
3. At least 18 years of age
4. Provision of signed and dated informed consent form
5. Stated willingness to comply with all study procedures and availability for the duration of the study
6. Ability and willingness to adhere to the study intervention regimen and follow-up visits

Exclusion Criteria:

1. Age less than 18 years.
2. Vulnerable population.
3. Pregnant, lactating or nursing women.
4. Unable to provide consent.
5. Presumed unable to complete follow-up assessments.
6. Prior adverse reaction or sensitivity to silver.
7. Enrollment in another interventional trial using a systemic therapeutic within 30 days prior to enrollment for this study.
8. Presumed impairment of wound healing as with prescription drugs or medical diagnoses that have potential to impair wound healing at the discretion of clinical investigator, e.g., cancer, transplant status, autoimmune disease, severe malnutrition, etc.
9. Any diagnosis with concern for 30 Day mortality.
The Purpose of the Study is to Gain an In-depth Picture of the Patient Management and Prescription Behaviours

'Real life' retrospective patient cases (10) to provide an objective and robust analytical report of patient management and prescriptions behaviours for Schizophrenia, Bipolar disorders and Major depressive disorders.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with one of the following conditions: Schizophrenia, Bipolar disorders and Major depressive disorders.

Exclusion Criteria:

* Patients who have not been diagnosed with the conditions as outlined in the Inclusion criteria.
Multi-Center Pre-Bariatric Weight Loss Study

The purpose of the study is to evaluate the safety and efficacy of the GI Sleeve in patients who require weight loss prior to their Bariatric surgery.

This is a randomized, patient blinded, prospective study.Patients will receive either a device or a sham procedure. Patients will be evaluated for the study and randomized to a treatment group if they qualify for the study. Throughout the study their weights will be obtained and various laboratory tests collected. A comparison of weight loss between the two groups will be assessed as the primary outcome measure.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 35 with a significant comorbid condition or BMI 40-60
* Candidate for Bariatric Surgery

Exclusion Criteria:

* No pathologies of the GI Tract
* No anti-coagulant or non-steroidal anti-inflammatory medications
PDR and SKYD of Dyslipidemia's Characteristics From the Oxidative Stress Enhancement Caused by Inhibition of Serine Metabolic Pathway

Clinical epidemiological investigation and modern statistics will be used. Syndrome was quantified by TCM syndrome score scale. Metabonomics, proteomics, transcriptomics, enzyme-linked immunosorbent assay, xanthine oxidation method and thiobarbital method will be used to detect the relevant indicators in serum, urine and tongue coating, and "disease syndrome cell model" will be constructed to detect the relevant indicators. Objective to clarify the epigenetic basis, molecular biological regulation mechanism and core function characteristics of phgdh expression decline caused by PDR and SKYD of dyslipidemia, analyze the correlation between phgdh, serine metabolic pathway product concentration and oxidative stress level, and reveal the scientific connotation of the disease syndrome.

Clinical epidemiological investigation and modern statistics will be used. Syndrome was quantified by TCM syndrome score scale. Metabonomics, proteomics, transcriptomics, enzyme-linked immunosorbent assay, xanthine oxidation method and thiobarbital method will be used to detect the relevant indicators in serum, urine and tongue coating, and "disease syndrome cell model" will be constructed to detect the relevant indicators. Objective to clarify the epigenetic basis, molecular biological regulation mechanism and core function characteristics of phgdh expression decline caused by PDR and SKYD of dyslipidemia, analyze the correlation between phgdh, serine metabolic pathway product concentration and oxidative stress level, and reveal the scientific connotation of the disease syndrome.

Eligibility Criteria:
Inclusion Criteria:

1. inclusion criteria of dyslipidemia with SKYD and PDR. (1) subjects with dyslipidemia in accordance with the diagnostic standards and TCM syndrome diagnostic standards, (2) ranged in age from 20 to 80, (3) who signed the informed consent, and (4) without lipid-lowering medications.
2. inclusion criteria of NC. (1) healthy subjects, (2) ranged in age from 20 to 80, (3) who signed the informed consent.

Exclusion criteria:

Exclusion criteria of dyslipidemia with SKYD and PDR. The exclusion criteria were composed of four criteria and a patient was excluded if they fails on any of the criteria. Mentioned criteria were: (1) secondary dyslipidemia (causes of dyslipidemia include but not limited to hypothyroidism, nephrotic syndrome, chronic renal failure, liver diseases, diseases of the hematopoietic system, adrenal-corticosteroid or contraceptive-drug induced dyslipidemia); (2) aphasias, and patients had difficulties to speak or unable to extend tongue for tongue observation; (3) patients with psychosis or unable to answer questions properly; (4) patients with acute infectious diseases or in the acute disease states (such as acute myocardial infarction, acute cerebrovascular disease, etc.), as well as pregnant women.