cyrilzakka/clinical-trials huggingface dataset:
Clinical Proof-of-concept Study on Rapid Immune Modulating Effects

Clinical-proof-of concept study, comparing the acute immune impacts of of 2 doses of a novel blend of supplements to a placebo. This study involves twenty-four participants, composed of healthy adults, who will be taking a placebo and 2 different doses of the blend at different times. Testing for immune status and cytokine levels will be conducted to determine the acute impact of the blend on immune function as compared to the placebo.

Clinical-proof-of-concept study comparing the acute immune effects of 2 doses of a nutraceutical blend, and a placebo. The nutraceutical blend is based on a transfer factor isolated from cow colostrum ultrafiltrate.

24 subjects will participate in a placebo-controlled, randomized, double-blinded, cross-over study design, wherein they will be taking placebo, dose 1, and dose 2, each separated by a 1-week washout period.

Blood samples are taken 1 hour after participants arrive; the dose is then administered. Samples are taken 1 hour, 2 hours, and 24 hours following administration. At each blood sample collection, a spit sample will also be taken for salivary IgA testing.

A series of immune panels will be used to determine the acute impacts on immune surveillance, immune cell activation status, immune cell priming, and cytokine profiles.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* Veins easy to see in one or both arms
* Willing to comply with study procedures, including
* Maintaining a consistent diet and lifestyle routine throughout the study;
* Consistent habit of bland breakfast on days of clinic visits
* Abstaining from exercising on and nutritional supplements on the morning of a study visit;
* Abstaining from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit;
* Abstaining from music, candy, gum, computer/cell phone use, during clinic visits

Exclusion Criteria:

* Previous major gastrointestinal surgery
* Taking anti-inflammatory medications on a daily basis
* Currently experiencing intense stressful events/life changes
* Currently in intensive athletic training (such as marathon runner)
* Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel
* An unusual sleep routine
* Unwilling to maintain a constant intake of supplements over the duration of the study
* Anxiety about having blood drawn
* People of childbearing potential: Pregnant, nursing, or trying to become pregnant
* Known food sensitivities related to ingredients in active test product placebo Prescription medication evaluated on a cas-by-case basis
GlucoClearTM System ICU Study

The primary purpose of this Study is evaluation of the safety and performance of the GlucoClear System (System).

The primary safety objective will be assessed by:

• Evaluation of any serious adverse device effects upon Sensor insertion through Sensor removal and a follow-up assessment one week (7 ± 3 days) after Sensor removal.

The primary performance objective will be evaluated using the following criteria:

15/20% Performance: Blood glucose measurements from the System must meet the ISO 15197 15/20% accuracy criteria (at least 95% of the matched pairs within ± 15 mg/dL of Comparator values ≤ 75 mg/dL and within ±20% of Comparator values \> 75 mg/dL).

Design: Non-randomized, non-treatment, prospective, open label Study.

After providing written informed consent, subjects meeting Inclusion/Exclusion Criteria will be connected to the System for a maximum of 72 hours.

For the purposes of this clinical Study, the System will not display real-time glucose values, glucose trend graphs, or glucose alarms to either the Study Subjects or the Study Site Personnel. There will be no treatment of any Subject based on the output of the System. Diabetes management decisions throughout this Study (if applicable) will be conducted according to hospital procedures.

* 1 set of laboratory measurements will be drawn per Subject for baseline.
* A maximum of 82 blood samples will be drawn per Subject during the 72 hour monitoring session including.

  * Up to 75 blood samples drawn for comparative glucose measurement on laboratory analyzers. Blood samples will be taken from the sampling catheter in the peripheral vein in the contralateral extremity (relative to placement of the System) with no more than 25 samples taken within one day (00:00 to 23:59) for glucose measurement on laboratory analyzers (e.g., Yellow Springs Instrument glucose analyzer (YSI), Radiometer blood analyzer);
  * Up to three (3) sets of laboratory measurements; and
  * Up to 4 other blood samples, as needed. One week (7 + 3 days) after Sensor removal, subjects will be contacted for a follow-up assessment and document any subsequent adverse events.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* ICU ≥ 24 hours
* Signed consent

Exclusion Criteria:

* Transplant patient
* Brain injury/surgery patient
* End stage medical conditions or diseases
* Restricted venous access
* History of HIT
* Contraindication for anti-coagulation or bleeding disorder
* Positive pregnancy test
* In other drug, device, or biologic study
Effect of Dynamic Cupping Versus Myofascial Release Therapy in Patients With Mechanical Neck Pain

A Quasi-experimental study will investigate the effect of dry cupping massage versus myofascial release on patients with mechanical neck pain.

PURPOSE: To investigate the effect of dry cupping massage versus myofascial release on pain level, range of motion, and functional level in mechanical neck pain...

BACKGROUND: Neck pain is a multivariate disease and is a leading issue in a modernized society. The economic burden of neck pain is remarkable and includes treatment costs, reduced productivity, and job-related problems (Cohen, 2015).

There is no one definitive treatment for neck pain. However, different pharmacological and non-pharmacological treatments have been recommended, including laser therapy, massage, acupuncture, yoga, and aquatic therapy (Corvillo et al., 2020). However, no studies are focusing on comparing the effect of dynamic cupping and myofascial release in mechanical neck pain.

HYPOTHESES: There will be a non-significant difference between dry cupping massage and myofascial release on pain level, range of motion, and functional level in patients with mechanical neck pain...

RESEARCH QUESTION: Will there be a difference between dry cupping massage versus myofascial release on pain level, range of motion, and functional level in patients with mechanical neck pain?

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18- 40 years.
2. Participants have experienced mechanical neck pain for at least the previous 3 months.

Exclusion Criteria:

* Participants aged below 18 years-old and those above 40 years old
* Mechanical neck pain due to trauma, disc protrusion, congenital deformity of the spine, spinal stenosis, and rheumatoid disease.
Study of SyB L-0501 in Combination With Rituximab to Treat Relapsed/Refractory Diffuse Large B-Cell Lymphoma

The purpose of this study is to determine the efficacy of SyB L-0501 in combination with rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma.

Primary Objective is to determine the efficacy, as measured by overall response rate on the basis of Revised Response Criteria for Malignant Lymphoma, of SyB L-0501 at 120 mg/m\^2/day on day2 and 3 in combination with rituximab at 375 mg/m\^2 on day 1 of each 21-day cycle in patients with relapsed/refractory diffuse large B-cell lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* Patients with documented Cluster of differentiation 20 (CD20)-positive for lymphoma cells
* Patients with measurable lesions
* Patients with measurable lesions \>1.5 cm in major axes
* Relapsed or refractory after 1 to 3 prior therapeutic treatments for diffuse large B-cell lymphoma.
* Patients who are expected to survive for at least 3 months
* Patients aged from 20 to 75 years at the time informed consent is obtained
* Performance Status (P.S.) of 0 to 1 at initial administration of the study drug
* Patients with adequately maintained organ functions
* Patients capable of personally giving voluntary informed consent in writing to participate in the study

Exclusion Criteria:

* Patients who have been without treatment for less than 3 weeks after prior treatment
* Patients who can be candidates for autologous peripheral blood stem cell transplantation at the discretion of the investigator.
* Patients who received adequate prior treatments and did not respond to any of them.
* Patients with central nervous system (CNS) involvement or patients with clinical symptoms suggestive of CNS involvement.
* Patients with serious, active infections
* Patients with serious complications
* Patients with complications or medical history of serious cardiac disease
* Patients with serious gastrointestinal symptoms
* Patients with malignant pleural effusion, cardiac effusion, or ascites retention
* Patients positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody, or HIV antibody
* Patients with serious bleeding tendencies
* Patients with a fever of 38.0°C or higher
* Patients with, or confirmed in the past to have had, interstitial pneumonia, pulmonary fibrosis, or pulmonary emphysema
* Patients with active multiple primary cancer or patients with a history of other malignant cancer within the past 5 years, except for basal cell cancer of the skin, squamous cell cancer, or cervical cancer in situ
* Patients with, or confirmed in the past to have had, autoimmune hemolytic anemia
* Patients who received SyB L-0501 in the past
* Patients who received cytokine preparation such as erythropoietin or granulocyte colony-stimulating factor (G-CSF) or blood transfusions within 2 weeks before the examination at registration for this study
* Patients who received other investigational products or unapproved medication within 3 months before registration in this study
Maternal Serum Amyloid A Levels in Pregnancies Complicated With Preterm Labour.

The aim of the current study is to assess the accuracy of maternal serum amyloid A for prediction of preterm labor in women with threatened preterm labor.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women, age 18 - 35.
* Gestational age: 28 - 36+6 weeks.
* Singleton pregnancy.
* No past history of any medical disorder and with no other medical complications during pregnancy
* Nonsmoker.
* Diagnosis of preterm labor is based on the American College of Obstetricians and Gynecologists Guidelines

Criteria of preterm delivery:

1. Gestational age: 28 - 36+6 weeks
2. Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes)
3. cervical dilation ≥ 4 cm
4. Cervical effacement ≥ 80%.

Exclusion Criteria:

* Of any patient with the following risk factors for preterm labor:

  * Over distended uterus .
  * hemorrhage
  * Uterine anomalies
Study of Otamixaban Versus Unfractionated Heparin (UFH) and Eptifibatide in Non-ST Elevation Acute Coronary Syndrome

Primary objective: To demonstrate the clinical efficacy of otamixaban (dose effect via 5 intravenous \[IV\] regimens) in patients with moderate-to-high-risk non-ST elevation acute coronary syndromes (ACS) and planned early invasive strategy.

Secondary objectives: To evaluate safety and assess pharmacokinetics (PK) and pharmacodynamics (PD).


Eligibility Criteria:
Inclusion Criteria:

* Ischemic discomfort at rest ≥ 10 minutes within 24 hours of randomization
* Electrocardiogram (ECG) criteria for non-ST elevation ACS or cardiac enzyme elevation (\> upper limit of normal \[ULN\])
* No ST elevation Myocardial Infarction (STEMI)
* Planned coronary angiography followed when indicated by a Percutaneous Coronary Intervention (PCI) on Day 1 to Day 3

Exclusion Criteria:

* Inability to undergo coronary angiography or PCI by Day 3
* Prior PCI within 30 days
* Acute STEMI
* Cardiogenic shock
* Anticoagulant treatment for \> 24 hours prior to randomization
* Prior treatment with fondaparinux since ACS onset
* Requirement for oral anticoagulant (OAC) prior to Day 30
* Creatinine clearance \< 30 ml/min
PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)

The purpose of the study is to evaluate the safety, tolerability, and clinical efficacy of PN-943 450 mg twice daily \[BID\] and PN-943 150 mg BID, compared with placebo BID, in subjects with moderate to severe active Ulcerative Colitis (UC).

The study consists of a 12-week double-blind, placebo-controlled treatment period. Participants will be randomized in a 1:1:1 ratio to PN-943 450 mg BID, PN-943 150 mg BID, or matching placebo BID.

Participants who successfully complete the double-blind period may be eligible for an extended treatment period of 40 weeks duration.

Eligibility Criteria:
Key Inclusion Criteria:

1. Male and female subjects age 18 (or the minimum country specific age of consent if \>18) to 75 years.
2. Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
3. Diagnosis of UC supported by appropriate documentation of biopsy results consistent with UC.
4. Moderate to severe active UC.
5. Demonstrated inadequate response, loss of response, or intolerance of at least 1 of oral aminosalicylates (5-ASAs), corticosteroids, immunomodulators, or a biologic (excluding vedolizumab).

Key Exclusion Criteria:

1. Subject with a current diagnosis of Crohn's disease (CD), indeterminate colitis (IC), microscopic colitis, ischemic colitis, radiation colitis.
2. History of colonic dysplasia other than completely removed low-grade dysplastic lesion.
3. History of active bacterial, viral, fungal or mycobacterial infection requiring hospitalization or IV antibiotic/anti-infective treatment within 4 weeks of screening or oral antibiotics/anti-infectives within 2 weeks of screening.
4. Prior treatment with vedolizumab, natalizumab, or any agent targeting the α4β7 or β1 integrin or planned during the study.
5. Positive stool test for C. difficile.
6. Chronic recurrent or serious infection.
7. Known primary or secondary immunodeficiency.
8. Pregnant or lactating female or considering becoming pregnant during the study or within 30 days after the last dose of study medication.
9. History of any major neurological disorders.
Vaginal vs. Laparoscopic Hysterectomy

Hysterectomy for benign indication is one of the most common surgical procedures in women. Numerous reviews and guidelines recommend the vaginal approach for benign hysterectomy, but the proportion of laparoscopic (and robotic) hysterectomies is increasing.

This study will compare a range of clinical and subjective outcomes of vaginal vs. total laparoscopic hysterectomy. Outcomes include operating time, postoperative recovery, return to work as well as cosmesis, quality of life and sexual health.


Eligibility Criteria:
Inclusion Criteria:

* benign indication for vaginal hysterectomy (e.g., abnormal uterine bleeding, fibroids, atypical endometrial hyperplasia)
* clinical exam indicates vaginal hysterectomy is feasible
* no major concomitant surgery
* able to complete questionnaires in German

Exclusion Criteria:

* uterine malignancy
* major concomitant surgery (e.g., for incontinence or prolapse)
* clinical exam indicating vaginal hysterectomy not feasible
* contraindication for surgery or laparoscopy
SPECTAbrain: Screening Patients With Brain Tumors for Efficient Clinical Trial Access

The SPECTAbrain protocol describes a structure for screening patients with brain tumors to efficiently allocate eligible patients in relevant therapeutic biomarker-driven clinical trials. Efficiency is promoted through the creation of a clinical database of brain tumor patients and the respective human biological material biobank for molecular characterization. The main objectives are to:

* Allocate patients to clinical trials according to the clinical characteristics and molecular profile of their tumor;
* Identify or validate new molecularly defined subgroups of tumors;
* Investigate the prevalence of novel biomarkers to plan future clinical trials;
* Enable exploratory/future research;
* Facilitate establishment of quality-assured and validated tests for Central Nervous System (CNS) tumor biomarkers;


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed newly diagnosed primary CNS tumors, with a focus on diffuse gliomas of grades II, III and IV, meningiomas from patients who are candidates for pharmacotherapy, and rare CNS tumors;
* Availability of adequate Human Biological Material (HBM): FFPE tissue sample from the primary and/or recurrent tumor and/or metastasis, obtained at the time of surgery or biopsy; minimal amount requested is detailed in the HBM guidelines. Inclusion of samples taken at any recurrence diagnosed during follow-up is strongly encouraged but optional;
* At least three months life expectancy;
* Written informed consent according to ICH/GCP and national/local regulations;
* Absence of exclusion criteria, such as active hepatitis B/C or HIV, second malignancies, severe organ dysfunction, or other comorbidities that will prevent inclusion into clinical trials.
MV-140 Efficacy in Recurrent Urinary Tract Infections in a Cohort of Portuguese Adult Patients

We will access the efficacy of MV-140 immunotherapy in the prevention of recurrent urinary tract infections in a cohort of Portuguese patients.

Urinary tract infections represent a highly frequent and debilitating disease, responsible for an extensive use of antibiotics for treatment and prophylaxis. Non-antibiotic therapies, such as oral vaccines, have been developed, in order to avoid antibiotic use. MV-140 is a sublingual vaccine comprised of 4 inactivated bacteria - E. coli, K. pneumoniae, E. faecalis and Proteus vulgaris. It is approved for the prevention of recurrent UTIs, with promising results in the few published results to date. The efficacy of this tool in the Portuguese population is, however, still unknown. Since the prevalence of pathogens responsible for infections and overall antibiotic use are highly variable worldwide, the results of studies conducted so far are not directly applicable in other regions. Therefore, we designed the present study which aims at assessing the efficacy of immunotherapy with MV-140 In the Portuguese population. It is a prospective observational study, in which patients will be asked to report their condition before and 1 year after therapy.

Eligibility Criteria:
Inclusion Criteria:

* At least 3 positive urine culture UTIs in the preceding 12 months
* Ability to understand and fill the informed consent

Exclusion Criteria:

I. History of genitourinary tumours II. Urinary lithiasis III. Immunodeficiency IV. Pregnancy V. Simultaneous use of any other urinary tract prevention vaccines or prophylactic antibiotics
Observational Study of Kibow Biotics in Chronic Kidney Failure Patients

A specifically formulated probiotic product comprised of defined and tested microbial strains may afford renoprotection in what has been generally called "Enteric DialysisTM". However, it is also referred to as enteric toxin reduction technology. Our hypothesis is to assess the potential benefits in devising a bowel-based probiotic formulation (Kibow® Biotics/RenadylTM) as a dietary supplement product for patients undergoing standardized care of treatment for their CKD stage 3 and stage 4 conditions.

Probiotics are increasingly utilized clinically. As their safety and health benefits are established, it is reasonable to anticipate that probiotic bacteria will be incorporated into a growing number of clinical regimens, as a dietary supplement.

Extensive in vitro R\&D investigations in Kibow's laboratories

Bacterial strains studied were a mixture of patented and proprietary strains of Streptococcus thermophilus (KB27), Lactobacillus acidophilus (KB31) and Bifidobacterium longum (KB35).

Oral administration of these bacterial formulations, tested in the 5/6th nephrectomized rat model (at Thomas Jefferson University, Phila., PA) and minipig model (at Indiana University, Indianapolis, IN), decreased both blood urea nitrogen (BUN) and serum creatinine (Scr) levels.

Two independent veterinarians investigated the effect of Kibow Biotics® in cats and dogs (of both genders and varying body weights) with moderate to severe kidney failure. Based on positive results, this formulation, marketed and distributed as AzodylTM, is currently licensed for veterinary applications to Vetoquinol USA.

Pilot scale studies, double blind, placebo controlled, cross-over studies for six months conducted in 45 patients in USA, Canada, Argentina, and Nigeria demonstrates reduction of BUN (P\>95%) and improved quality of life (P\>95%). Decrease in creatinine and uric acid levels were also observed. However, these studies were based on correlating the age of geriatric cats and dogs with moderate to significant kidney failure to human geriatric conditions. The proposed current study is being reevaluated based on correlating the weight basis of animal to human conditions. Hence, this is a does escalation study on ingestion of 1x (90 billion CFU/day), 2x (180 billion CFU/day), and 3x (270 billion CFU/day) dosages.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75 years
* CKD Stages 3 and 4 as documented by prior medical history
* Serum Creatinine \>2.5 mg/dL
* Stable and on CKD status 3 and 4 at least for a year or more

Exclusion Criteria:

* Pregnant or nursing women
* Refusal to sign the informed consent form
* Documented to have HIV/AIDS/Liver disease
* Active dependency on drugs or alcohol
* Any non-related medical, debilitating disease/disorder that would interfere with adherence to this study
* Currently on anticoagulant therapy
Improving Care Through Improv: Promoting Mastery in the Moment

The goals of this clinical trial are to: 1) refine the training program, "Improving Care though Improv;" and 2) test the program for its influence self-perceived caregiving mastery (i.e., how persons assess their ability to provide care) among informal caregivers of persons living with moderate dementia. Forty-three informal caregivers will be involved in testing the training program. These individuals will be assigned to groups of between 8 to12 caregivers and take part in weekly 2-hour sessions held over a 4-week period. These caregivers will be taught improvisational (improv) theater skills, which involves being in the moment, self-awareness, and responsiveness to others. This group also will be asked to answer surveys questions about themselves and the person receiving care at three timepoints and invited to provide feedback on their training experiences.


Eligibility Criteria:
Inclusion Criteria:

* Actively engaged in the care of community-dwelling persons living with moderate dementia (4 or 5 on a 7-point dementia-staging scale) who is not likely to be institutionalized within the next 6 months
* Able to attend at least 3 of the 4 in-person sessions
* Ability to communicate in English