cyrilzakka/clinical-trials huggingface dataset:
Pulsed Electromagnetic Fields for Postoperative Pain: a Linical Trial in Humans

This randomized clinical trial was designed to assess the clinical efficacy of Pulsed electromagnetic field PEMF delivered with a wearable device in terms of postoperative pain and quality of healing after mandibular third molar extraction.

The sample included 120 patients undergoing unilateral mandibular third molar extraction. The devices were positioned over the area corresponding to the extraction site and wearers were asked to keep them in place for 7 days. All patients were asked to record pain (on a visual analog scale \[VAS\]), hours of wearing the device (groups T and P), and any use of analgesics. At 7 days, healing complications (dehiscence, tumefaction, pus, local lymphadenopathy, pain on palpation, postoperative bleeding, alveolitis) were recorded blindly.

Introduction: Pulsed electromagnetic field (PEMF) therapy is a noninvasive method for delivering pulsed radiofrequency energy to tissues to treat postoperative pain and edema. This randomized clinical trial was designed to assess the clinical efficacy of PEMF delivered with a wearable device in terms of postoperative pain and quality of healing after mandibular third molar extraction.

Materials and methods: The sample included 120 patients undergoing unilateral mandibular third molar extraction. At the end of the surgical procedure, patients were randomly assigned to a test (T) or placebo (P) group and fitted with enabled or disabled PEMF devices, respectively, or to a control (C) group not fitted with a PEMF device. The devices were positioned over the area corresponding to the extraction site and wearers were asked to keep them in place for 7 days. All patients were asked to record pain (on a visual analog scale \[VAS\]), hours of wearing the device (groups T and P), and any use of analgesics. At 7 days, healing complications (dehiscence, tumefaction, pus, local lymphadenopathy, pain on palpation, postoperative bleeding, alveolitis) were recorded blindly.

Eligibility Criteria:
Inclusion Criteria:

* patients who needs third molar extraction,
* good oral hygiene,
* no contraindications to treatment.

Exclusion Criteria:

* age under 14 years;
* poor oral hygiene (plaque index less then 20%);
* contraindications for surgery (or anesthesia);
* infectious or systemic diseases;
* immunosuppressant therapy;
* pregnancy or breastfeeding;
* mental disorders.
TAP Block Catheters vs Liposomal Bupivacaine for Pain Control After Colorectal Surgery

This is a prospective randomized study designed to compare the pain control from a single shot of liposomal bupivacaine (Exparel) against transversus abominus plane (TAP) catheters with ropivicaine bolus in patients undergoing elective colorectal surgery.

At UC Davis, it is standard practice to place TAP blocks with catheters for adult colorectal surgery patients for perioperative pain control. This practice, however, is resource intensive, adds the risk of catheter-related complications, and adds increased burden to patients by requiring them to be tethered to 2 catheters.

An alternative TAP can be performed using a single shot of liposomal bupivacaine (Exparel), an extended release local anesthetic that is FDA-approved for surgical plane infiltration including TAP blocks.

With this prospective study, we seek to improve patient care at UC Davis and educate other institutions through the use of concrete data comparing these 2 treatment options.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective colorectal surgery with Dr. Linda Farkas

Exclusion Criteria:

* Patients under 18 years of age
* Patient over 90 years of age
* Pregnancy
* Prisoners
* Patients unable to provide consent
* Patients on systemic anticoagulation therapy
* Patients with an allergy to local anesthetics
Safety, Tolerability and Pharmacokinetics of ONC1-0013B in Patients With Progressive Metastatic Castration-resistant Prostate Cancer

This is a PhaseI, open-label study, Dose-Escalation Study, where tolerated doses will be escalated to the next doses with the safety, tolerability, and PK being evaluated in metastatic castration-resistant prostate cancer (mCRPC) patients. Tumor assessment and PSA values will be evaluated during the study as an additional point.


Eligibility Criteria:
Inclusion Criteria:

1. Men aged 18 years and older.
2. Histologically confirmed diagnosis of prostate cancer
3. Castrate level of testosterone in blood serum \< 1,7 nmol/l or \< 50 ng/dl
4. PSA level at screening \> 2 ng/ml
5. Progression of metastatic CRPC after the chemical castration with gonadotropin-releasing hormone (GnRH) analogue or after the chemical castration and subsequent chemotherapy.
6. The patient's ECOG performance status of 0 - 2
7. Patients previously treated with docetaxel chemotherapy should have received 2 or less prior lines of chemotherapy for mCRPC
8. The expected survival time of not less than 12 weeks

Exclusion Criteria:

1. Prior anticancer therapy:

   * Treatment with chemotherapeutic agents or radiotherapy within 4 weeks prior to screening or preserved toxicities of ≥ II grade according to CTCAE scale, related to prior anticancer therapy (excluding alopecia)
   * Prior antiandrogen therapy: flutamide within 4 weeks prior to screening or bicalutamide within 6 weeks prior to screening
   * Exposure to bisphosphonates is allowed only if the treatment started prior to screening
2. Clinically significant cardiovascular system diseases:
3. Clinically significant central nervous system diseases:
4. History of other significant concomitant diseases which, in the Investigator's opinion, may cause a disease recurrence (i.e. uncontrolled diabetes mellitus)
5. Prior or concomitant therapy:

   * Exposure to drugs which may cause a convulsive state within 4 weeks prior to screening
   * Exposure to treatment with characteristics of CYP3A4 or CYP2D6 inhibitors within 4 weeks prior to screening
   * Exposure to treatment relating to the Class I risk of QT-interval prolongation; exposure to treatment relating to the Class II risk of QT-interval prolongation is allowed if the patient have received not less than 5 half-life periods of flat-dosed treatment
Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children

Primecrolimus cream 1% is effective in the treatment of atopic dermatitis in African American children.


Eligibility Criteria:
Inclusion Criteria:

* African American children aged 2 to 17 years
* mild to moderate atopic dermatitis

Exclusion Criteria:

* m-EASI less than 3 at baseline
* allergy to Elidel or components
* use of oral steroids, immunosuppressive agents,cytostatics of phototherapy within 4 weeks prior to study.
* previous continuous or non-continuous use of pimecrolimus or tacrolimus for greater than 11 months within 2 weeks of enrollment.
* active skin infections.
* immunocompromised patients.
* previous history of skin cancer or lymphoma
* any hypopigmentation in study areas
* pregnant or breastfeeding
* participation in another investigational trial
A National Study of Clinical Results After Emergency Operation for Perforated Diverticulitis

The aim of this study is to evaluate clinical results and effect on health and well-being in patients operated for perforated diverticulitis with purulent peritonitis by laparoscopic lavage in Sweden when used outside of prospective studies/trials and in comparison with the traditional treatment, i.e. colon resection with or without stoma formation.

A secondary aim is to evaluate the outcome after fecal peritonitis.

The hypothesis is that laparoscopic lavage as treatment for perforated diverticulitis with purulent peritonitis is safe, efficient and cost saving, when used in routine health care.


Eligibility Criteria:
Inclusion Criteria:

* All patients registered in the Patient registry with ICD 10 codes K57 classified as emergency admissions and with the Nordic Medico-Statistical Committee (NOMESCO) code JAH01(diagnostic laparoscopy), JFB46 (resection of sigmoid colon), JFB60 (resection of sigmoid colon, sigmoidostomy and closure of the distal stump), JFB61 (laparoscopic resection of sigmoid colon, sigmoidostomy and closure of the distal stump), JFB63 (other colon resection, colostomy and closure of the distal stump), JAK04 (laparoscopy and peritoneal lavage), JAW97 (other laparoscopic operation involving abdominal wall, mesentery, peritoneum or the omentum)

Exclusion Criteria:

* Patients where hospital records reveal that the index admission was misclassified (not perforated diverticulitis) will be excluded.
* Patients classified as Hinchey 1-2.
* No informed consent received or withdrawal of consent (questionnaire)
Diagnostic Role of the "White Test" With Lipidic Solution in the Early Intraoperative Identification of Open Bile Ducts for the Prevention of Bile Leakage After Liver Resection (BiLe -Trial)

Bile leakage (BL) is the most frequent complication after liver resection. This study is to investigate the role of intraoperative administration of SMOFlipid 20% (fat emulsion which allows intraoperative identification of open bile ducts at the liver resection surface when it is administered retrograde through the cystic duct) in terms of prevention of postoperative BL within 30 days after surgery.

Bile leakage (BL) is the most frequent complication after liver resection leading to the need of interventional drainage, endoscopic retrograde cholangio pancreatography (ERCP) or even reoperation. Strategies leading to a reduction of the rate of this complication are valuable. SMOFlipid 20% is a fat emulsion which is primary indicated for parenteral nutrition. Because of its fatty content this solution is white. This allows the clear intraoperative identification of open bile ducts at the liver resection surface when it is administered retrograde through the cystic duct. Consequently, open bile ducts can be sutured preventing the postoperative development of BL. If the rate of bile leakages can be reduced, resources for interventions and relaparotomy will be saved. This study is to investigate intraoperative administration of SMOFlipid 20% in terms of prevention of BL within 30 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will receive an anatomical resection of two or more liver segments for any reason with simultaneous cholecystectomy in elective Setting
* Patients who will receive an anatomical resection of two or more liver segments for any reason which already had a cholecystectomy if intraoperatively the cystic stump can be identified and opened
* Ability of subject to understand character and individual consequences of the clinical Trial
* Informed consent documented by signature

Exclusion Criteria:

* Previous cholecystectomy if intraoperative it is not possible to identify the cystic stump
* Intraoperative hepatico-jejunostomy
* Hypersensitivity to fish-, egg-, soybean or peanut protein or to any of the active ingredients or excipients
* Immunosuppression, pregnancy
* Emergency liver resection because of traumatic liver rupture
* Enrolment of the investigator, his/her family members, employees and other dependent persons
Satiety Response of Four Dietary Fibers

Studies have found a relationship between dietary fiber consumption and body weight regulation. This relationship may stem from enhanced satiety through fermentation of certain fibers in the large intestine.

The objective of this study is to determine and compare satiety ratings, changes in food intake, and gastrointestinal effects for four fibers: fructooligosaccharide, inulin, soluble corn fiber, and resistant starch.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women
* Age 18-40 years
* Nonsmoking
* Not taking weight loss medications
* Non-dieting (weight has not changed more than 11 pounds over three months)
* BMI between 18.5 and 29
* Spoken and written English literacy

Exclusion Criteria:

* Do not regularly consume breakfast
* Food allergies to wheat, soy, peanut, or dairy
* BMI less than 25 or greater than 29 upon admission to study
* Cancer diagnosis in past 5 years
* History of heart disease, kidney disease, diabetes, or eating disorder
* History of ulcerative colitis, Crohn's disease, or any other gastrointestinal condition
* History of drug or alcohol abuse in past 6 months
* Use of lipid-lowering, anti-hypertensive, or anti-inflammatory steroid medication
* Concurrent or recent (within 30 days) intervention study participation
* Pregnant or lactating
* Irregular menstrual cycle
* Vegetarians
* People who eat more than approximately 15 grams of fiber per day
The Effects of Local Vibration and Cervical Stabilization Exercises Applied on Neck Muscles on Balance in Healthy Individuals

In healthy individuals, many postural musculoskeletal problems arise due to various reasons. The cervical region is the region where these problems are most common. The cervical region ranks second in the general population after the lumbal area of musculoskeletal system disorders and affects close to 70% of the general population.The most important causes of this posture disorder are; muscular performance and strength are inadequate, as well as decreased proprioception of the muscles, deterioration of the individual balance systems that result in individual visual or vestibular problems.

Exercise therapy is at the forefront of these methods, while a variety of methods are applied in the prevention and treatment of neck problems. Recent studies have focused on multifaceted treatments including exercises to improve strength, endurance and coordination of cervical muscles, proprioceptive training, relaxation exercises to prevent muscle tension, stabilization exercises and behavior modification. Cervical stabilization exercises are a frequently used exercise approach. Cervical stabilization exercises, which are different from ordinary exercises, are based on biomechanics, neurophysiology and physiotherapy research. The main objective of this method is; improve body awareness, maintain posture uniformity, improve strength, endurance, coordination and proprioception. Stabilization exercises also increase the strength and endurance of the postural and stabilizer muscles, improving stability control in the stabilized and non-stabilized positions.

Another method that contributes to the development of balance and proprioceptive sense is vibration application. Proprioception plays an important role in ensuring the coordination of movements. When the proprioception input is disturbed, both the position sense and the speed of movement may be affected. Muscle-tendon vibration is a noninvasive method that is often used in proprioception studies. It has been suggested that the vibration application are the enhancing effect of the proprioceptive. However, there is not enough research on this subject.

The purpose of this study is to determine whether the cervical stabilization exercises to be applied to the cervical region and the local vibration applied to the neck muscles are related to muscle performance, proprioception and balance and their superiority with each other.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who have not had neck pain in the last six months.

Exclusion Criteria:

* Patients with atypical spinal cord anomalies, inflammatory or rheumatologic disorders, malignancy history, radiculopathy, myelopathy or other neurological disorders, vestibular disorders, and vertebral trauma history who underwent any surgical treatment for vertebral colonic at least 3 months before, was not included in the study.
Countering Young Adult Tobacco Marketing in Bars

The goal of the study is to implement and evaluate interventions to decrease smoking among young adults attending bars and nightclubs. It is believed that the proportion of young adult current smokers during and after the intervention will be significantly less than the proportion of young adult smokers before the intervention in each of the study cities.


Eligibility Criteria:
Inclusion Criteria:

* Participants are healthy volunteers 18-26 years old currently living in San Diego, Portland, Albuquerque, Oklahoma, San Francisco/Bay Area, Nashville, Tucson, or Los Angeles who attend bars or nightclubs
* Able to read, speak, and understand English
* NOTE: PARTICIPANTS CAN ONLY TAKE PART IN THE STUDY BY ENCOUNTERING STUDY SURVEY TEAMS OUT AT BARS OR NIGHTCLUBS IN ONE OF THE STUDY CITIES LISTED ABOVE. PARTICIPANTS CANNOT SIGN UP FOR THE STUDY BY CALLING OR EMAILING.

Exclusion Criteria:

* Out of age range (18-26 years old)
* Not living in San Diego, Portland, Albuquerque, Oklahoma, San Francisco/Bay Area, Nashville, Tucson, Los Angeles or New York City, or currently attending college outside of the target cities.
* Unable to read, speak, or understand English.
* Unwillingness or inability to participate or give informed consent.
A Study to Evaluate the Effectiveness and Safety Initiation and Titration of Insulin Glargine (U300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus (T2DM) Controlled on Oral Antidiabetic Drug Treatment in Turkey

Primary Objective:

To assess the mean change in HbA1c (glycated haemoglobin).

Secondary Objectives:

To evaluate the efficacy and safety of the titration of insulin glargine U300 in terms of:

* Targeted HbA1c;
* Targeted fasting self- monitoring blood glucose (SMBG);
* Hypoglycemic events;
* Adverse events;
* Quality of life assessment by DTSQs (Diabetes Treatment Satisfaction Questionnaire status) and DTSQc (Diabetes Treatment Satisfaction Questionnaire change);
* Blood glucose fluctuation by using continuous glucose monitoring system (CGMS) in subgroup patients.

The total study duration per patient will be 27 weeks (2 weeks of screening, 24 weeks on treatment, and 1 week follow-up period).

Eligibility Criteria:
Inclusion criteria :

* Adult patients with type 2 diabetes mellitus (≥18 years of age).
* Type 2 diabetes mellitus diagnosis ≥1 year.
* Treated with ≥1 oral antidiabetics (±glucagon like peptid-1 (GLP-1) analogue) without insulin, for at least 6 months and HbA1c level between 8-11% (insulin-naïve).
* Stable antidiabetic treatment for at least 3 months.
* Willingness to adherence to treatment and titration (including self-injection, self- monitoring blood glucose \[SMBG\]).
* Signed informed consent obtained.

Exclusion criteria:

* Age \<18 years old.
* Type 1 diabetes mellitus.
* Having secondary type 2 diabetes mellitus.
* Use of any insulin therapy including premix, basal plus/basal bolus regimen from the diagnosis.
* History of hypoglycemia unawareness.
* Known hypersensitivity/intolerance to insulin glargine or any of its excipients.
* Have any condition (including known substance or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the study protocol.
* Use of systemic glucocorticoids for two weeks or more within 12 weeks prior to the time of screening.
* Pregnant or lactating women.
* Participation in another clinical trial.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Orientation Booklet for Low Back Pain

The aim of this study was to evaluate the effect of exercises performed under monitoring of the physiotherapist and self performed at home by reading the booklet of exercise orientation for patients with nonspecific low back pain.

A prospective and randomized trial was performed in 44 patients. G1 patients received a physiotherapist orientation, and G2 patients received the booklet of exercise to self perform the exercises. Pain intensity by Visual Analogue Scale (VAS), and quality of life by SF-36 were measured before.

Results: Pain intensity was lower in G1 than in G2 after 6 and 12 weeks. Quality of life was better in G1.

The exercises under orientations of the physiotherapist promoted best effect than self performed exercises .

After approval by the Ethics Committee and signing a consent form, a prospective, randomized trial was performed in 44 patients with chronic nonspecific low back pain (lasting longer than 3 months), pain intensity greater than 3 by visual analogue scale and age \> 18 years. Patients with renal and gastrointestinal disease, simultaneously submitted to another type of physical therapy, cognitive impairment, and pregnant women were excluded.

All patients received an exercise booklet which consisted of stretching and strengthening of muscles. G1 patients were orientated by the physiotherapist during the performance of exercises once a week, using the booklet, and the patients in G2 (n=22) received the booklet to self perform the exercises without orientation of the physiotherapist. Everyone should perform the exercises once a day at home.

Pain intensity by VAS, and quality of life by SF-36 were measured before the start of treatment (T0), after 6 (T6) and 12 (T12) weeks. Side effects were recorded. Acetaminophen (up to 4 g / day) could be used as necessary.

The sample size was provided by SAS 8.0, SPSS 15.0 program. To detect difference in pain intensity of 3 between the groups by VAS, with 95% of power (estimated SD= 2.0), when the alpha level is set at 0.05, the sample should be of 16. The program used for statistical analysis was SAS 8.0, SPSS 15.0. The tests used were Student's T to compare age of patients, chi-square to compare gender and analgesic complementation, and Mann Whitney test for pain intensity and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* chronic nonspecific low back pain (lasting longer than 3 months),
* pain intensity greater than 3 by visual analogue scale and age \> 18 years

Exclusion Criteria:

* Patients with renal and gastrointestinal disease,
* simultaneously submitted to another type of physical therapy,
* cognitive impairment, and
* pregnant women were excluded
INvestigating DIGital Outcomes in the Community

To explore the feasibility and best methodology for collecting patient-reported outcome measures in patients who have previously been treated for cancer and are living in the community.

The investigators are working with primary care research teams, and using an online electronic questionnaire. Although the study is entirely observational, the study offers some of the questions in a random order, so the investigators can explore the effect of changing the way in which questions are asked.

INDIGO Community aims to both collect data on patient-reported outcome measures (PROMS) and patient-reported experience measures (PREMS) and data on the impact of how to do this.

The focus is on adult patients living in the community who have previously been treated for cancer.

The study uses a range of quality of life questionnaires, and randomises the order in which some questions are asked, in order to explore the impact of how questions are asked on responses.

All patients with be offered the EuroQol 5 dimension, 5 level questionnaire (EQ5D-5L)

Eligibility Criteria:
Inclusion Criteria:

* Anyone over the age of 16 who has been diagnosed (receiving treatment is not an inclusion criteria although the investigators expect as this is a long-term survivorship study all participants will have received treatment) for any type of cancer in the past (\> 12 months) can participate.
* Participants who self-identify as having previously (time unlimited) received a diagnosis of cancer, based on histological, radiological, or clinical grounds (primary and/or metastatic cancer). Current treatment is not a barrier to participation, but the emphasis is on patients who have completed treatment.

Participants need to be able to access the secure online platform, using a mobile device or computer.

* Have capacity and be able to provide informed consent via the online platform.
* To be able to understand, read and write English, with or without support from a trusted individual e.g., friends, family, carer.

Exclusion Criteria:

* Participants recently diagnosed with cancer (less than 12 months ago).
* Participants unable to access secure online platform.
* Participants who do not have sufficiently good understanding of written English to complete the PROMs and are unable to be supported by a trusted individual to complete the questionnaire.
* Participants lacking capacity and unable to give informed consent.