cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Popliteal Nerve Blocks With and Without Dexamethasone on the Duration of Analgesia for Foot & Ankle Surgery

The purpose of this research study to evaluate the effects of dexamethasone as an addition to peripheral nerve block (Put the nerve to sleep with Bupivacaine a numbing medication) on length of pain relief (analgesia), postoperative narcotic (opioids) requirements, pain scores, and patient satisfaction after foot and ankle procedures.


Eligibility Criteria:
Inclusion Criteria:

* 60 patients (30 per group) undergoing foot and ankle procedures
* Willingness and ability to sign an informed consent document
* No allergies to anesthetic or analgesic medications
* American Society of Anesthesiologists (ASA)physical status Class I - III
* Aged 18-90 years,either sex

Exclusion Criteria:

* Refusal to participate in the study
* Age\<18 or\> 90 years -
* Contraindications to regional blockage including but not limited to:
* Patient refusal to regional blockade
* Infection at the site of needle insertion
* Systemic infection
* Bleeding diathesis or coagulopathy
The Antiaggregation Monitoring (TAM) Registry

The purpose of this study is to investigate the incidence of acetylsalicylic acid resistance (ASA-R) among patients under chronic acetylsalicylic acid(ASA) treatment seen at our outpatient clinic.

Acetylsalicylic acid (ASA) resistance (R) is best defined as an ineffective inhibition of the platelet cyclooxygenase (COX)-1 pathway, and has been reported in 1 to 61 % of patients treated with ASA. Impaired response to ASA has been associated with an increased risk of ischemic events in patients with known coronary artery disease. We sought to investigate the incidence of ASA-R in clinical practice.

All consecutive patients under chronic ASA treatment (100mg/d) seen at our outpatient clinic were systematically included in the registry. All patients were on acetylsalicylic acid for CAD for at least 1 month. Patients were informed of ASA testing at start of consultation in the outpatient clinic. Eligible patients provided written informed consent. Peripheral venous blood samples were analyzed using the whole blood impedance platelet aggregometry Multiplate analyzer. The Multiplate analyzer device allows to measure platelet aggregation by the attachment of platelets to two silver coated copper electrodes leading to a rise of electrical resistance in the sample. The measurements are expressed as arbitrary aggregation units (AU) and the manufacturers defined cutoffs were used: normal values were 76-136 AU, partial antiaggregation was defined as ASA values between 31 and 75 AU and complete antiaggregation was defined as ASA values \< 31 AU.

Eligibility Criteria:
Inclusion Criteria:

* patients under chronic ASA treatment for more then one month

Exclusion Criteria:

* concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs)
* thrombocytopenia
* thrombocytosis
* age \<18 years
SeMaglutide and Albuminuria Reduction Trial in Obese Individuals Without Diabetes

Study to assess the effects of weekly subcutaneous administration of the GLP1-RA semaglutide 2.4mg on kidney function parameters in obese/overweight individuals at high risk of CKD progression.

Glucagon Like Peptide 1 Receptor Agonist (GLP1-RA) therapies have been introduced as antidiabetic drugs. In addition, GLP1-RA therapies reduce body weight, in patients with and without diabetes, without inducing hypoglycemia. Moreover, GLP1-RA reduce albuminuria in patients with type 2 diabetes, and liraglutide and semaglutide have been shown to improve various risk markers of CKD progression in non-diabetic obese individuals. It is therefore likely that these agents delay progression of kidney function decline in high risk obese/overweight, non-diabetic individuals.

The main objective of the study is to assess the albuminuria lowering effects of semaglutide 2.4 mg s.c. once weekly (Semaglutide 3 mg/ml) compared to placebo in obese/overweight non-diabetic individuals with elevated albuminuria. This will be tested in a 24-week randomized placebo controlled double-blind two arm parallel clinical trial with a 4 week wash-out period after 24 weeks double blind treatment to assess off drug effects.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Body Mass index ≥ 27 kg/m2
* Albuminuria ≥ 30 mg/g and ≤ 3500 mg/g
* eGFR ≥ 25 ml/min/1.73m2
* Stable renal function prior to entry into the study defined as no more than 30% eGFR change in 3 months prior to enrolment
* Signed Informed Consent

Exclusion Criteria:

* Diagnosis with type 1 or type 2 Diabetes
* Hba1c ≥ 6.5% at screening
* Cardiovascular disease event in 3 months prior to enrollment
* Treatment with GLP-1 RA \< 4 weeks prior to screening
* Uncontrolled thyroid disease TSH\>6.0 mIU/L or \<0.4 mIU/L at screening
* Acute pancreatitis \< 180 days prior to screening
* History or presence of chronic pancreatitis
* Females of child-bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures
Computer Guided Esthetic Crown Lengthening

The objective of the present study was to evaluate the effectiveness of surgical esthetic crown lengthening using digitally assisted 3D printed surgical stents in management of excessive gingival display due to altered passive eruption.

The objective of the present study was to evaluate the effectiveness of surgical esthetic crown lengthening using digitally assisted 3D printed surgical stents in management of excessive gingival display due to altered passive eruption.

Primary objectives:

Wound healing Score: the clinical features of periodontal wound healing were measured according to Hagenaars et al using the following parameters: swelling of the soft tissue , color of the gingiva, probing pocket depth, bleeding index, plaque index, clinical attachment level. These signs were assessed at 1 week, 3 months and 6 months post-operative.

Operating time: the time needed to complete each procedure was calculated in minutes by using a stopwatch from the time of the first incision till the completion of bone removal.

Secondary objectives:

Patient satisfaction: was assessed using visual analogue scale at 24 hours, 7 days and 14 days post operatively. (Zero is for minimum pain and ten is for maximum pain).

Gingival margin stability: The position of gingival margin in relation to a reference point was evaluated immediately after surgery, 3 months and 6 months healing period .

Eligibility Criteria:
Inclusion Criteria:

1. Males and females within age range of 20-40 years.
2. Systemic (medically) free individuals.
3. Excessive gingival display in the esthetic zone (more than 3mm of gingival display at full smiling)
4. Patients with good oral hygiene.

Exclusion Criteria:

1. Smokers (15)
2. Teeth with compromised periodontium.
3. Pregnant and lactating females.
4. The vulnerable group: patients with mental or physical disabilities.
5. Patients with parafunctional habits.
6. Medications that affect periodontal wound healing.
7. Periodontal surgery in the esthetic zone in the past 6 months.
Metabolic Cost of Medicine Ball Training

In this study, the investigators will be able to estimate the metabolic cost of several foundational medicine ball training exercises.

Medicine ball training has become a popular cardiovascular training choice in fitness centers and athletic performance enhancement facilities. Despite widespread use and growing popularity, little is known about the metabolic demands of such a training method. Therefore, the purpose of this study was to quantify the cardiovascular and metabolic cost from various foundational medicine ball exercises in order to contribute to a better planning of exercise programs in the real world.

Ten healthy young adults were assigned to execute fourteen bodyweight exercises (acute bout) of which seven exercises will be executed by throwing the medicine ball and seven exercises will be executed without a medicine ball throw. Anthropometric, metabolic, functional capacity and performance measurements were conducted at baseline. The metabolic cost was estimated from heart rate, blood lactate, resting oxygen uptake, exercise oxygen uptake, and excess post-exercise oxygen consumption measurements using a portable gas analyzer.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 35 years
* Physically active individuals
* Free of chronic diseases
* Free of musculoskeletal injuries
* Nonsmokers

Exclusion Criteria:

* Musculoskeletal injuries
* Chronic diseases
* Use of alcohol, caffeine and any type of ergogenic supplements or medication before (≤6 months) and throughout the study.
CT Follow-Up of the SImmetry Sacroiliac Joint Fusion System

This study will evaluate long-term follow-up of subjects implanted with the SImmetry Sacroiliac (SI) Joint Fusion System (SImmetry).


Eligibility Criteria:
Inclusion Criteria:

* Patient must have a SImmetry device implanted.
* Patient is willing to comply with study procedures and provide informed consent.

Exclusion Criteria:

* Patient is physically unable to return to the clinic for CT imaging.
Clinical Trial of Green Tea Catechins in Men on Active Surveillance

This randomized double-blinded Phase II clinical trial will evaluate the bioavailability, safety, effectiveness and validate the mechanism by which a standardized formulation of whole Green Tea Catechin, (Sunphenon® 90D) containing 405 mgs vs. Placebo, administered for 24 months in a cohort of men with low to intermediate grade prostate managed on active surveillance


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Biopsy-proven (consisting of ≥ 12 tissue cores) adenocarcinoma of the prostate with cancer present in at least one biopsy core (TRUS or/and mpMRI/TRUS fusion), Gleason score (3+3) or predominant Gleason pattern 3 (3+4), ≤ 33% of biopsy cores, and ≤50% involvement of any biopsy core (Participant meets all criteria for Active Surveillance as determined by MD)
* Willing to start or continue on active surveillance
* Baseline/screening serum PSA \<10 ng/mL
* No other prior treatment for PCa, including focal therapy
* ECOG performance status 0-1
* No history of renal or hepatic disease, including history of hepatitis B and C
* Meet hematological eligibility parameters (Neutrophil count ≥ 1,200/mm3 (≥1.2 k/μL), Stable platelet count ≥ 75,000/mm3 (≥ 75k/μL) Hepatic and renal function eligibility parameters, serum total Bilirubin ≤ULN (ULN: 1.2 mg/dl) (or ≤3.0 mg/dL for patients with Gilbert's syndrome), AST or ALT \<1.5x ULN and Serum creatinine ≤1.5 x ULN
* Willing to abstain from consumption of any supplements containing GTC
* Willing to restrict tea consumption to less than three (3) servings of hot tea or three (3) servings of iced tea per week
* Willing to discontinue current vitamin/mineral supplement use and use one provided by study
* Willing to take study agent or placebo at the dose specified with meals.

Exclusion Criteria:

* Have had prior treatment for PCa by surgery, irradiation, local ablative (i.e., cryosurgery or high-intensity focused ultrasound), or androgen-deprivation therapy)
* Men who are currently treated or those treated in the past 3 months prior to day of randomization with 5- alpha-reductase inhibitors (e.g., finasteride, dutasteride)
* Participants who have PCa with distant metastases
* Participants who have been treated with: hormone therapy, immunotherapy, chemotherapy and/or radiation, for any malignancies within the past 2 years prior to registration.Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. All patients with metastatic disease will be excluded
* Participants may not be receiving any other investigational agents
* History of allergic reactions attributed to tea or compounds of similar chemical or biologic composition to green tea extracts.
Clinical Trial to Assess the Efficacy of µSmin® Plus

This study evaluates treatment with the dietary supplement µSmin® Plus in a group of patients suffering from chronic venous insufficiency in comparison with a similarly-sized group of patients receiving placebo evaluated by quality of life questionnaires, VAS pain scale, CVI symptomatology, and change in the circumference of the affected leg at calf level

In this study we use a dietary supplement - µSmin® Plus - for symptomatic treatment of CVI and we will monitor its impact on CVI symptoms, features, and consequences (item) of the disease listed below: limb edema, walking, daily tasks performance, pain/burning symptoms, pruritus/paresthesis, sensation of heaviness/fatigue, time wasted in the management of the disease, social burden, disease impact on self-confidence, and its impact on physical exercise/recreational activities. Results of related clinical trials were published before showing that this is an active field in clinical reasearch.

Eligibility Criteria:
Inclusion Criteria:

* Male or female with age ≥18 and ≤60 with chronic venous insufficiency;
* The chronic venous insufficiency must be graded between C2-C4 on the Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification system;
* Able to communicate adequately with the investigator and to comply with the requirements for the entire study;
* Capable of and freely willing to provide written informed consent prior to participating in the study;
* Light smokers (\<10 cigarettes per day).

Exclusion Criteria:

* Patients suffering from other or associated vascular diseases, diabetes or bleeding disorders;
* Oedema of the lower limbs of cardiac, renal or hepatic origin;
* Presence of symptoms and/or trophic disorders of arterial, metabolic, neurological or orthopedic origin including traumas, arthritis, neuropathy;
* One or more factors likely to affect venous symptoms such as recent childbirth, recent stripping, or deep or superficial venous thrombosis of the lower limbs during the previous 6 months;
* Obese subjects (BMI \> 30);
* Hypersensitivity to active principles contained in the tested food supplement (diosmin);
* Patients considered smokers (≥10 cigarettes/day);
* Patients with concomitant or history of addiction to alcohol, spices or drug abuse;
* Pregnant women, nursing mothers, or women (only if childbearing potential) not using adequate methods of contraception;
* Participation in an interventional clinical study in the previous 30 days;
* Presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study.
A Randomized, Comparative, Double-blind Trial of Pentaisomaltose and Dimethyl Sulphoxide for Cryoprotection of Hematopoietic Stem Cells in Subjects With Multiple Myeloma or Malignant Lymphoma With a Need for Autologous Transplantation

A randomized, comparative, double-blind trial of pentaisomaltose and dimethyl sulphoxide for cryoprotection of hematopoietic stem cells in subjects with multiple myeloma or malignant lymphoma with a need for autologous transplantation

The trial is a randomized, comparative, double-blind trial comparing the efficacy and safety of pentaisomaltose (PentaHibe®, Pharmacosmos A/S, Holbæk; termed PIM in the following) and dimethyl sulphoxide (DMSO), when used for preservation of harvested hematopoietic stem cells. Approximately 150 subjects with a diagnosis of multiple myeloma or malignant lymphoma (a minimum of 30 % of each diagnosis and an equal distribution in each preservation group) and undergoing autologous stem cell transplantation (ASCT) will be included.

The subjects will be randomized 1:1 to receive ASCT preserved in the following cryo-protective agent (CPA):

* A: PIM 16 %
* B: DMSO 10 %

Eligibility Criteria:
Inclusion Criteria:

* Men or women ≥ 18 years
* Multiple myeloma or malignant lymphoma diagnosis in which ASCT is indicated according to the standard procedures at the hospital
* Willing to be hospitalized for minimum 24 hours after the ASCT
* Willingness to participate and signing the ICF

Exclusion Criteria:

* Multiple myeloma or lymphoma invasion of the central nervous system
* Previous treatment with ASCT
* Severe infection
* Unsuitable for apheresis
* Unable to provide ≥3 bags with a cell concentration ≥2.0×106 CD34+ cells/kg bodyweight per bag during apheresis
* Pregnant or nursing women. To avoid pregnancy, women of childbearing potential have to use adequate contraception (e.g., intrauterine devices, hormonal contraceptives, or double barrier method) during the whole trial period and up to 1 year after the last ASCT
* Men, even if surgically sterilized, (i.e., status post vasectomy), who do not agree to practice effective barrier contraception during the entire trial period and through 6 months after the last ASCT, or agrees to completely abstain from heterosexual intercourse
* Any other medical condition which, in the opinion of the Investigator, will put the subject's disease management at risk or may result in the subject being unable to comply with the trial requirements
Study to Investigate the Safety, Tolerability, Absorption, Distribution, Metabolism, and Elimination of RWJ-445380 Administered to Patients With Plaque Psoriasis

The primary objective of the study is to evaluate the safety and tolerability of 50, 100, 200, and 300 mg/day doses of RWJ-445380 for up to 12 weeks in patients with plaque psoriasis

Trials with a new, first-in-class drug will be done to ascertain safety, tolerability, absorption and other effects in the treatment of psoriasis, such as effects on biomarkers. Approximately 60 adult patients with psoriasis covering at least 3 percent of their body surface area will be recruited for the study. They will be randomly assigned to one of 5 treatment arms each patient has an equal chance of receiving the placebo, 50 mg, 100 mg, 200 mg, or 300 mg dose. Patients will receive study medication in a blinded fashion, i.e, the patient, the doctor and the study sponsor will not know what group the patient is in until all patients complete the study. Patients will take the medication daily for 12 weeks. The study will be enrolled in two enrollment groups of about 30 patients each, so that extent of side effects can be ascertained and expectations on their extent confirmed. The investigator and the sponsor will monitor the study for the occurrence of possible side effects. In addition to a screening visit, patients will have visits every week for the first month, and then every two weeks until 12 weeks of treatment. At 12 weeks, there are 2 visits on consecutive days for tests and there is one followup visit 4 weeks after the last dose of study drug is taken.

Medical history, physical examination, blood pressure and heart rate, and ECGs are checked periodically. Blood samples will be taken for standard laboratory tests as well as special tests of the drug blood level, biomarkers to see whether the drug might be affecting the biological pathway of antigen presentation, and skin biopsies from areas both involved and not involved with psoriasis. The blood and skin samples will be used to see whether some of the characteristics of psoriasis are changed by taking the drug. Samples will also be taken to see whether certain types of immune cells are affected by taking the drug. Immunizations with tetanus and hepatitis A vaccines will be done to see if taking the drug might affect immune responses to these agents. Patients will receive RWJ-445380, 50, 100, 200, 300 mg, or placebo. Patients will receive an oral capsule daily for up to 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of plaque psoriasis for at least 6 months
* willingness to undergo tissue biopsies

Exclusion Criteria:

* No current oral or injectable medications for psoriasis (30 days to 3 months)
* no other major health issues
The Effect of a Multi-modal Program on Fear of Cancer Recurrence in Breast Cancer Patients

The goal of this clinical trial is to learn if MMP intervention can alleviate FCR , breast cancer symptoms and social support among breast cancer patients. he main questions it aims to answer are:

* Null Hypotheses (H0): There is no significant difference in FCR, breast cancer symptoms, and social support between the MMP intervention group and the control group.
* Alternative Hypotheses (H1): There are significant differences in FCR, breast cancer symptoms, and social support between the MMP intervention group and the control group

Researchers will compare MMP to a routine care to see if MMP works to alleviate FCR, breast cancer symptoms and social support.

Participants will:

* Receive interventions once per chemotherapy cycle for 8 weeks.
* The FCRI-SF, MSAS-SF-SC, and SSRS scales will be utilized to assess FCR levels, breast cancer symptoms and social support in both the experimental and control groups, with measurements conducted at baseline (T1), 8 weeks post-intervention (T2), and 12 weeks post-intervention (T3).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis meets the criteria outlined in the Breast Cancer Diagnosis and Treatment Guidelines, with a pathological diagnosis of breast cancer and currently undergoing chemotherapy
* Age ≥ 18 years
* Clear consciousness and the ability to communicate independently
* Aware of the diagnosis and has signed the informed consent form

Exclusion Criteria:

* Presence of mental illness or cognitive impairment
* Hearing or speech impairmen
* Distant metastasis of cance
* Severe physical illness or other malignant tumors requiring treatment
Effectiveness of Plaque Score Detection Techniques

This study investigates the similarity between microbial plaque scores when assessing the entire dentition versus select teeth. The hypothesis posits that plaque buildup on single teeth mirrors that of the entire mouth, facilitating efficient plaque data collection and generalized deductions. Additionally, the research explores the potential of Dental Monitoring© photos in accurately identifying plaque indexes, aiming to enhance plaque evaluation efficiency in dental appointments. The null hypothesis suggests no significant difference between full dentition plaque scores and selected teeth. Results may streamline plaque tracking in patient appointments and enable remote monitoring, potentially detecting plaque accumulation issues earlier.

Following the obtainment of participant consent, data will be collected during participant's routine prophylaxis appointment or during designated clinic time open for participants to volunteer. Utilizing a scan box provided by Dental Monitoring©, a scan (series of intra-oral images) will be taken of the participant's dentition. The scan will be taken once before disclosing solution (erythrosine) is introduced to the dentition and once after.

The disclosing solution will allow for visualization of plaque. The presence of plaque on all teeth surfaces will be recorded using the O'Leary Plaque Index. No procedures (other than the intra-oral photos), interventions, evaluations or tests will be performed more frequently than they would be if the participant was not participating in the research. The only participant demographic information that will be recorded for this study is age.

Participants who opt to come in voluntarily for only data collection will not receive a prophylaxis. Their plaque information will be collected, and they will be dismissed.

Oversight procedures in place: The Scan Boxes will be utilized by the investigators to take intra-oral photographs of each patient's dentition. These will be sterilized between each participant and stored in the College of Dentistry's clinic lockers when not in use.

Eligibility Criteria:
Inclusion Criteria:

* 19-85 years old
* Patient at the University of Nebraska Medical Center (UNMC) College of Dentistry
* One molar, premolar or canine pe quadrant

Exclusion Criteria:

* No permanent dental devices (braces, splints)
* Less than 20 non-restored teeth present in the dentition