cyrilzakka/clinical-trials huggingface dataset:
Lap-assisted vs. US-Guided Visualization of TAP Blocks

Peripheral nerve blocks have been effective in decreasing post-operative pain as well as the use of narcotics for numerous years. Typically, these blocks are placed by anesthesiologist via ultrasound. In more recent years, surgeons have been placing nerve blocks laparoscopically. Since there are few studies that looks compare the two techniques we aim to perform a randomized control trial to demonstrate if a laparoscopic placed nerve block is as efficient and accurate as an ultrasound placed block.

Ultrasound-guided peripheral nerve blocks like the transversus abdominis plane (TAP) block are useful for post-operative pain control and reducing opioid analgesics.(1-3) A recent meta-analysis of TAP blocks in adults demonstrated a reduction in post-operative opioid requirements, and improved pain scores.(2) Within the pediatric population, numerous other studies have confirmed the benefit of TAP blocks and their ability to lower pain scores, reduce opioid use and opioid-related side effects post-operatively.(4) While there have been many prospective randomized trials for ultrasound-guided TAP blocks (5-7), there has been limited evaluation of surgically-placed TAP blocks (8). There has been no published data evaluating or comparing surgically placed TAP blocks in pediatric patients undergoing laparoscopic procedures. placed TAP blocks in pediatrics have not been examined in patients undergoing laparoscopic procedures.(4) Our pilot study was designed as a proof of concept, to demonstrate that ultrasound images could be used to verify the distribution of local anesthetic after a laparoscopically-assisted TAP block. The aim of this study is to continue using ultrasound to verify the location of laparoscopic-assisted TAP blocks, and compare the post-operative outcomes (pain scores, opioid use, etc.) to those who receive ultrasound-guided TAP blocks. We plan to do this in a prospective, randomized and semi-blinded fashion.

We hypothesize that (1) we will be able to accurately describe the location of the TAP block placed by both methods in more than 90% of cases; (2) laparoscopic-assisted TAP blocks will be as effective as ultrasound-guided TAP blocks in terms of managing/reducing post-operative pain scores and reducing the amount and frequency of postoperative opioid analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 0-18 years who are undergoing laparoscopic surgery at Lucille Packard Children's Hospital
* Clinical indication for abdominal peripheral nerve block

Exclusion Criteria:

* conversion to open procedure
* allergy to local anesthetic
* multiple procedures planned with \>1 surgical specialty
Minoxidil Response Testing in Males With Androgenetic Alopecia

Topical minoxidil is the most common drug used for the treatment of AGA in men. While topical minoxidil exhibits a good safety profile, the efficacy in the overall population remains relatively low i.e., 30-40% re-grow hair. To observe significant improvement in hair growth, minoxidil is typically used twice daily for a period of at least 16 weeks. Due to the significant time commitment and low response rate, a diagnostic test to identify non-responders prior to initiating therapy would be advantageous.

Minoxidil is converted in the scalp to its active form, minoxidil sulfate, by the sulfotransferase enzyme SULT1A1. The enzyme expression is variable among individuals. We have demonstrated in two prior feasibility studies that the SULT1A1 enzyme activity in plucked hair follicles correlates with minoxidil response in the treatment of AGA and thus can server as a predictive biomarker.

Consequently, we developed a minoxidil response in-vitro diagnostic kit intended to identify non-responders prior to initiating therapy with 5% topical minoxidil foam.

The primary purpose of this study is to evaluate the clinical validity of the minoxidil response in-vitro diagnostic kit.


Eligibility Criteria:
Inclusion Criteria:

* Males in overall good health
* Age: 18 to 49
* Diagnosed with male androgenetic alopecia with vertex pattern IIIv, IV, or V on the Norwood Hamilton Scale
* Willing to have a mini dot tattoo placed in the target area of the scalp
* Willing to maintain the same hair style, color, shampoo and hair products use, and approximate hair length throughout the study
* Able to give informed consent
* Able to comply with the study requirements for 16 consecutive weeks

Exclusion Criteria:

* Previous adverse event from topical minoxidil treatment
* Does not use and have not used in the past 6 months anti-androgen therapy such as finasteride
* Does not use and have not used in the past 6 months minoxidil (topical or oral)
* Does not take medication known to cause hair thinning such as Coumadin and anti-depressants/anti-psychotics
* Folliculitis
* Scalp psoriasis
* Seborrheic dermatitis
* Inflammatory scalp conditions such as lichen planopilaris
Evaluation of Implant Stability in Low Quality Bone Following the Use of Osseodensifiers Versus Ridge Expanders

the use of osseodensification technique compared to ridge expansion screws in low bone quality

using Densah burs in preparation of implant osteotomy compared to ridge expansion screws in low quality bone

Eligibility Criteria:
Inclusion Criteria:

* • Single tooth missing in the maxillary region with D3 (350-850 HU) and D4 (150-350 HU) bone (Sultana et al., 2020).

  * A minimum of 4 mm residual buccolingual bone width at site of implant placement (Koutouzis et al., 2019).

    * The recipient site of the implant should be free from any pathological conditions.
    * No diagnosed bone disease or medication known to affect bone metabolism.
    * Patients who are cooperative, motivated and hygiene conscious.
    * Patients having adequate inter-occlusal space of 8-10 mm (Fernández et al., 2017)

Exclusion Criteria:

* Systemic conditions/diseases that contraindicate surgery (Jarikian et al., 2021).

  * Patients who have any habits that might jeopardize the osseointegration process, such as current smokers (Vollmer et al., 2020).
  * Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching (Sultana et al., 2020).
  * Alcohol or drug abuse (Ibrahim et al., 2020).
  * Pregnant and lactating women.
Re-irradiation for Pelvic Recurrences in Rectal Cancer Patients

This study investigates the potential benefit of re-irradiation of patients with locally advanced rectal recurrences, by a prospective phase II clinical, imaging and translational research study.

The overall purpose of this trial is to evaluate the efficacy of re-irradiation of patients with locally advanced rectal cancer (LRRC) recurrences who previously received pelvic irradiation. Patients with potentially resectable LRRC will be treated with hyperfractionated Intensity-Modulated Radiotherapy consisting of 40.8 Gy in 1.2 fractions twice daily with concomitant oral capecitabine followed by surgery, when feasible.

Eligibility Criteria:
Inclusion Criteria:

* Locally recurrent rectal cancer
* Previous pelvic RT for rectal cancer and surgery
* Potentially resectable by MRI and palpation by MDT evaluation
* Absence of non-resectable distant metastases by PET-CT
* Age ≥ 18
* Adequate organ function
* Acceptable bowel and bladder function
* Acceptance for TR sampling

Exclusion Criteria:

* Central small recurrences deemed immediate resectable
* Previous radiotherapy \<12 month prior to recurrence
* Non-resectable systemic or regional disease
* Unable to undergo MRI or PET-CT
* Medical comorbidities precluding radical surgery
Improved Prostate Cancer Diagnosis - Combination of Rapid Prebiopsy Magnetic Resonance Imaging and Biomarkers

This study will enroll 200 men with clinical suspicion of prostate cancer due to higher serum level of PSA than 2.5 ng/ml or abnormal digital rectal examination.

Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) at 3 Tesla (T) magnetic field using surface coils will be used to non-invasively predict the presence or absence of prostate cancer.

Targeted TRUS guided biopsy based on MRI findings will be performed in addition to routine twelve core TRUS biopsy.

Moreover, selected serum and urine biomarkers as well as biomarkers extracted from fresh biopsy sample will be collected and correlated with the presence or absence of prostate cancer.

Specific aims of the current study are as follows:

i) To determine the sensitivity, specificity and accuracy of a novel rapid anatomical MRI and DWI at 3T magnetic field for the detection of prostate cancer in correlation with systematic TRUS guided biopsy

ii) To determine the sensitivity, specificity and accuracy of selected serum, urine and tissue biomarkers for detection of prostate cancer

iii) To develop statistical model for diagnosis of prostate cancer incorporating findings of a novel rapid MRI/DWI and selected biomarkers

iv) To assess the applicability of TRUS guided prostate biopsy based on MRI finding in patient with no previous prostate biopsy

v) To develop and validate an imaging protocol which will become the standard protocol for prostate imaging at Medical Imaging Centre of Southwest Finland (VSKK) / TYKS, Turku, Finland.

Eligibility Criteria:
Inclusion Criteria:

* Age: 40 to 85 years
* Language spoken: Finnish
* Clinical suspicion of prostate cancer, based on: serum level of PSA from 2,5 ng/ml to 25 ng/ml in two following measurements and/or abnormal digital rectal examination
* Mental status: Patients must be able to understand the meaning of the study
* Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

* previous prostate biopsies
* previous diagnosis of prostate carcinoma
* previous prostate surgeries, e.g. TURP (transurethral prostatic resection)
* symptomatic of acute prostatitis
* contraindications for MRI (cardiac pacemaker, intracranial clips etc)
* uncontrolled serious infection
* claustrophobia
* any other conditions that might compromise patients safety, based on the clinical judgment of the responsible urologist
How do You Take Your Coffee Before Anesthesia

Undergoing anesthesia requires patients to fast pre-operatively to allow the stomach to empty and prevent aspiration pneumonia but patients are allowed to drink "clear" liquids up to 2 hours before surgery. Clear liquids are defined as water, carbonated sodas, black coffee or tea without milk or sugar, and juices without pulp. Many Americans prefer to take their coffee with half and half or coffee creamer rather than black. This study will determine whether the addition of a small amount of cream to coffee makes any difference to the volume in the stomach after 2 hours.

This study will use healthy volunteers as study participants. Each participant will participate in the study 3 times with at least 2 days in between. We will use a bedside ultrasound machine to measure their stomach content volume at baseline and then they will consume one of 3 different prepare drinks - black coffee, coffee with half and half, or coffee with non-dairy coffee creamer. After 2 hours, we will scan their stomach again and measure stomach content volume and compare it to the first measurement. The participants will repeat this two more times on different days so that they would have had a chance to consume all three prepared coffee drinks in a random order.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-65

Exclusion Criteria:

* Diabetes mellitus
* Delayed gastric emptying
* Previous gastric surgery
* Lactose intolerance
* Current pregnancy
* Consumption of solid/liquids in 6 hours prior to commencement of ultrasound study
Mechanism of Hypersensitivity Reactions to Iron Nanomedicines

Iron deficiency is common and when oral treatment is not sufficient intravenous application is indicated. Hypersensitivity to intravenous iron nanomedicines is rare but does occur and little is known about the underlying mechanism but complement activation has been suggested.

This is a purely exploratory study as it is not yet known whether in vitro complement activation can be stimulated by titration with iron preparations. These data will provide first empirical evidence of whether and to what extent complement activation occurs in this population.


Eligibility Criteria:
Inclusion Criteria:Group 1)

* adult participants from 18-65 years of age
* previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject) Group 2)
* adult participants from 18-65 years of age
* previous intravenous ferric carboxymaltose (Ferinject) and no hypersensitivity reaction Group 3)
* adult participants from 18-65 years of age
* previous hypersensitivity reaction grades I-IV to iron sucrose (Venofer) Group 4)
* adult participants from 18-65 years of age
* previous intravenous iron sucrose (Venofer) and no hypersensitivity reaction

Exclusion Criteria:

* Group 1)-4) • Autoimmune disorder or immune deficiency
Comparison of Outpatient and Inpatient Spa Therapy

In this study, we aimed to compare the effectiveness of inpatient and outpatient physical therapy modalities and spa combination treatments on pain and functional status in patients with knee osteoarthritis.

Osteoarthritis (OA) has an important place in musculoskeletal diseases and is the most common rheumatic joint disorder characterized by progressive cartilage degeneration. Osteoarthritis of the knee is the most common symptomatic osteoarthritis characterized by chronic knee pain, joint stiffness, limited daily activities, and decreased quality of life.

In this study, it was aimed to compare the effects of inpatient and outpatient applications of HP, US, TENS, spa combination treatments on pain and functional status in patients with knee osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with primary knee osteoarthritis

Exclusion Criteria:

* Patients who have secondary knee osteoarthritis due to various diseases
* Patients with pronounced pathology in the waist, hip and ankle joint, patients with active tumors
* Patients with febrile infectious disease
* Having had serious surgical operations in the last 6 months
* Patients who have undergone and/or have been injected with intraarticular steroid and hyaluronic acid into the knee joint
* Patients who have received balneotherapy and peloidotherapy in the last one year
* Patients with decompensated organ failure, those with inflammatory disease, those with pregnancy and breastfeeding
* People with neurological diseases such as epilepsy, inner ear hearing aids, pacemakers and other individuals with a small metallic implant
Dermatological Assessment of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Phototoxicity.

This is a clinical study for health care product safety assessment. The research is going to conducted with 55 subjects, aged 18 to 70 years. The product is applied on the right and/or left participant back. After a wash out, the product is reapplied. Medical evaluation will be available throughout the study to assess possible adverse events. The main of the study is to observe the effects of the application of the product on the skin and prove the absence of irritability and/or allergy, photoallergy and phototoxicity.

Subjects phototypes I to IV (according to Fitzpatrick classification). The products is applied over semi-occlusive dressings, remaing in contact with the skin.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants;
* Non-injured skin in the test region;
* Agreement to adhere to the test procedures and requirements and to attend the institute on the day(s) and at the time(s) determined for the evaluations;
* Ability to consent to participation in the study;
* Phototype (Fitzpatrick): II and III;

Exclusion Criteria:

* Pregnant or breastfeeding women;
* Use of the following systemic drugs: antihistamines, non-hormonal anti-inflammatory drugs and corticoids;
* History of allergy to cosmetics, topical products or research product;
* Localized or widespread dermatological diseases or inflammatory dermatoses active and nerve damage in the test region;
* Personal or family pathological history of skin cancer;
* Use of topical or systemic photosensitizing medication;
* History of phototoxic, photoallergic reactions, dermatoses caused by light, atopy, pathologies aggravated or triggered by ultraviolet radiation;
* Photo-induced pathologies;
* Frequent exposure to the sun or tanning chambers;
* Participated in an allergenicity study in a period of less than 4 weeks from the start of the study;
* Skin marks in the experimental area that interfere with the evaluation of possible reactions;
* Active dermatoses;
* Forecast to take a bath in the sea, pool or sauna during the study;
* Participants who play water sports;
* Dermography;
* Use of the following topical or systemic drugs: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs and corticoids up to 2 weeks prior to selection or, considering deposit corticoids, the interval shall be 1 month prior to selection;
* Treatment with acid vitamin A and/or its derivatives via oral or topical until

  1 month before the beginning of the study;
* Aesthetic and/or body dermatological treatment until 3 weeks before selection;
* Vaccination during the study or until 3 weeks before the study;
* Being participated in another clinical trial.
Attitudes and Knowledge of Oral Health Among Nursing Personnel

Oral Health care has been shown to have low priority among nursing personnel, especially among personnel with shorter education.

As the population gets older and keep their natural teeth high up in age, in most cases throughout life, it is of importance to help the older maintain a good oral health when the cognitive functions and physical ability decreases. In 1999, a new dental care system was introduced with the aim to offer elderly with long-term need for extensive care, home visits for oral health assessment and, if necessary, be offered the necessary dental care. The aim was also to offer nursing personnel education and training in dental health and oral care, in order to provide and perform oral care. The effect of the education program has never been evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Nursing personnel in nursing home for elderly
* Must be able to read and understand Swedish

Exclusion Criteria:

- None
Feasibility Study of Phototherapy System to Treat H Pylori

This purpose of this study is to determine whether phototherapy can be used to safely and effectively treat H pylori.

H pylori causes almost all peptic ulcers and many gastric cancers and is widely prevalent worldwide. Treatment by multiple antibiotics and proton pump inhibitors is effective but are compromised today by significant non compliance due to side effects and duration of required treatment. Also, the increase in antibiotic resistance coupled with the decreased availability of new antibiotics project a significant population of patients who will not be treatable with antibiotics.

A special, visible-light based phototherapy system has been demonstrated to significantly decrease the viability of H pylori in vitro and in a brief clinical experiment.

This study will evaluate the safety and short term efficacy in up to 60 patients of the phototherapy system to treat H pylori.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 and \< 90
* Documented positive for H. pylori infection by urease breath test, stool antigen or histology within thirty days prior to procedure
* Willing to comply with study requirements
* Able to undergo endoscopic esophagogastroduodenoscopy (EGD) with biopsy

Exclusion Criteria:

* History of gastric or duodenal carcinoma
* History of prior gastric or duodenal surgery
* Oral or intravenous antibiotics use within previous one month
* Use of bismuth subsalicylate (Pepto Bismol) within previous one month
* Use of photosensitizing drugs or nutritional supplements within previous one month
* Active peptic ulcer disease (gastric or duodenal ulcer)
* Esophagitis Grade II or higher
* Oral or intravenous antibiotics use within previous one month
* History of a bleeding disorder or anti-coagulant use that would prevent biopsy
* PPI treatment two weeks prior to the scheduled endoscopy
* Positive Pregnancy Test
* Known porphyria
* Suffer from phenylketonuria (PKU)
* Signs of jaundice
* Weight \< 100 lb or \> 250 lb
* Previously enrolled in this study
* Participating in another ongoing clinical trial in which concomitant diagnosis or therapeutic intervention would adversely affect the integrity of this study
* The subject is inappropriate for study participation, as determined by the Investigator
Bio-availability of a New Liquid Tumeric Extract

Curcumin is a commonly-used spice and food coloring. Evidence suggests that curcumin can suppress tumor initiation, promotion and metastasis in a variety of tumor cell lines. The current available curcumin has low bioavailability restricting the effect of curcumin in non-colon cancer. In this study we plan to test a new liquid tumeric/curcumin extract, Curcumol (patent pending, Israel Patent Application No. 181,121). We predict the bioavailability of the liquid tumeric/curcumin extract will be better compared to the currently used curcumin powder.

Twelve healthy participants enrolled to the study. All volunteers will have pre study evaluation to confirm healthy state. After enrollment, each participant will be tested twice, one with the liquid tumeric/curcumin (study drug) and once with the curcumin powder (control). The days of testing will be on two days, separated by two weeks wash-out period. The participants will be assigned to randomly receive study drug or control on the 1st day, with the other regimen administered at the 2nd day. Both study drug and control will be diluted in 150ml of water. The doe of study drug will be escalated from 30 drops (4 participants), 50 drops (4 participants) and 70 drops (4 participants). Blood sample will be collected at 0,0.25,0.5,0.75,1,2,3,4,5,6,8h post drug. Quantization of curcumin plasma levels will be done by the high pressure liquid chormatography method. A biomarker for the potential effect of curcumin, platelet function pre and post curcumin consumption will be tested.

Eligibility Criteria:
Inclusion Criteria:

* Complete Healthy
* Able to attend two full days of study
Measurement of Low-energy Stimulation in Patients With Atrial Fibrillation

Multistage low-energy pulses are being evaluated for their effect on atrial fibrillation during an acute testing procedure.

This is a research feasibility study to evaluate various parameters of the multistage low-energy pulses and their effect on atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria:

* patients indicated for an atrial fibrillation ablation procedure

Exclusion Criteria:

-
Dual-loop Target Controlled Infusion for Coadministration of Propofol and Remifentanil Guided by Narcotrend Index

To investigate the application of closed target-controlled infusion(TCI) of propofol and remifentanil guided by Narcotrend index in the anterior cervical decompression and fusion with internal fixation surgery.

Sixty patients scheduled for anterior cervical decompression and fusion with internal fixation surgery under general anesthesia were randomly divided into two groups:closed-loop (group A,n=30) and open-loop group(group B,n=30).The procedure during induction of anesthesia was same in two groups.In group A,if Narcotrend index(NI) fall down to 46 and keep more than 30 seconds,propofol and remifentanil were intravenously infused as feedback automatically to achieve the target NI of 26-46.However,the NI in group B was controlled manually.

Eligibility Criteria:
Inclusion Criteria:

1. ASA Ⅰ \~ Ⅱ women undergoing Laparoscopic surgery.
2. Written informed consent from the patient or the relatives of the participating patient.
3. BMI:18.0～25 kg/m2

Exclusion Criteria:

1. Mental illness can not match
2. epidural anesthesia contraindicated
3. People who have Slow-type arrhythmias
4. Chronic renal failure
5. Alcohol or drug abuse
6. Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug