cyrilzakka/clinical-trials huggingface dataset:
An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following Various Sized Lunches As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers

The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release tablet following a 400 to 500 calorie, 600 to 750 calorie, or 800 to 1000 calorie medium-fat lunch as compared to pregabalin immediate release capsule 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet following various sized lunches as compared to a single dose of the pregabalin immediate release capsule.

Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet under various conditions as compared to single dose of pregabalin IR capsule

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or females
* Between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion Criteria:

* Illicit drug use
* Pregnant or nursing females
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
A Study of Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Participants With Obesity or Overweight With Type 2 Diabetes

The main purpose of this study is to see how well and how safely bimagrumab, tirzepatide, and the combination, work in lowering body weight in participants with obesity or overweight and type 2 diabetes. Participation in the study will last about 13 months.


Eligibility Criteria:
Inclusion Criteria:

* Have type 2 diabetes
* Have a BMI of ≥27 kilograms per square meter (kg/m2)
* Have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss)

Exclusion Criteria:

* Have a prior or planned surgical treatment for obesity,
* Have type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis or hyperosmolar state or coma
* Have poorly controlled hypertension
* Have any of the following cardiovascular conditions within 3 months prior to screening:

  * acute myocardial infarction
  * cerebrovascular accident (stroke)
  * unstable angina, or
  * hospitalization due to congestive heart failure
* Have a history of New York Heart Association (NYHA) Functional Classification III or IV congestive heart failure
* Have ongoing or a history of frequent intermittent or chronic tachyarrhythmia syndromes
* Have ongoing or a history of bradyarrhythmias other than sinus bradycardia
* Have renal impairment
* Have a history of symptomatic gallbladder disease within the past 2 years
* Have signs and symptoms of any liver disease
* Have a disease or condition known to cause gastrointestinal malabsorption or a known clinically significant gastric emptying abnormality
* Have a history of acute or chronic pancreatitis
* Currently taking or have taken medications that may cause significant weight gain or promote weight loss within 3 months prior to screening
Bathing Additives in Pediatric Atopic Dermatitis

The current clinical guidelines for management of atopic dermatitis now recommend bleach baths. This requires simply the addition of regular household bleach to twice-weekly baths. At the Mayo Clinic, dilute acetic acid (vinegar) has been recommended for decades in wet wraps to treat patients hospitalized for their atopic dermatitis. However, this practice has not been widely adopted in the pediatric dermatology community. Will the use of dilute acetic acid (vinegar) in twice weekly baths help manage atopic dermatitis in pediatric patients as well as, or better than, the current accepted guidelines?


Eligibility Criteria:
Inclusion Criteria:

1. Patients from 6 months to 17 years of age
2. Currently residing in US.
3. Follow up visits at 1 month, 3 months and 6 months after initiation of treatment in study (Figure 1).
4. Last follow-up at 1 year in clinic or via written mailed-out survey.
5. Diagnosis of atopic dermatitis AND

   1. Have active signs of bacterial skin infection OR
   2. Any documented suspected history of bacterial skin infection (weeping, crusting, and/or pustules on exam), OR
   3. Prescription for oral antibiotics for skin infection in the past 6 months from any provider). OR
   4. Have been prescribed bleach baths as part of an atopic dermatitis skin care regimen.

Exclusion Criteria:

1. Superficial skin infection without diagnosis of atopic dermatitis
2. Lack of in-clinic follow up assessment at 6 months
A Study of Elranatamab (PF-06863135) in Chinese Participants With Refractory Multiple Myeloma.

The purpose of this study is to understand the study medicine (called Elranatamab, or PF-06863135) as potential treatment for refractory multiple myeloma. Multiple myeloma is a form of cancer in the bone that forces healthy blood cells to go out. Sometimes, multiple myeloma does not respond to current therapy or quickly progresses, and this is called refractory multiple myeloma.

Elranatamab is a study medicine that target multiple myeloma and activates the human body to fight against this disease. We are seeking Chinese participants to take part in this study. The study will be 2 parts, called part 1b and part 2. In part 1b, participants will receive Elranatamab at 2 steps priming and full dose as a sc (subcutaneous injection) therapy. We will monitor participants' safety and reactions to the study medicine. This will help us understand the dosage of Elranatamab to be used safely.

In part 2 of the study, participants will receive Elranatamab and their multiple myeloma growth will be monitored. This will help us understand if Elranatamab, when used alone, may be a therapy for refractory multiple myeloma. Participants in this part of the study are expected to take part for about 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)
* Measurable disease, as defined by at least 1 of the following:
* Serum M-protein ≥0.5 g/dL
* Urinary M-protein excretion ≥200 mg/24 hours
* Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio
* Refractory to at least one IMiD
* Refractory to at least one PI
* Refractory to at least one anti-CD38 antibody
* Relapsed/refractory to last anti-myeloma regimen
* ECOG performance status ≤2
* Adequate BM function characterized by the following:

  1. Absolute neutrophil count ≥1.0 × 10\^9/L
  2. Platelets ≥ 25 × 10\^9/L
  3. Hemoglobin ≥8 g/dL
* Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
* Not pregnant and willing to use contraception

Exclusion Criteria:

* Smoldering multiple myeloma
* Active Plasma cell leukemia
* Amyloidosis
* POEMS syndrome
* Stem cell transplant or active GVHD within 12 weeks prior to enrollment.
* Previous treatment with an anti-BCMA directed therapy
* Impaired cardiovascular function or clinically significant cardiovascular diseases
* Ongoing Grade ≥2 peripheral sensory or motor neuropathy. History of GBS or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.
* Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection
* Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
* Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
Clinical Efficacy of a New Piezoelectric Technique for Wisdom Teeth Extraction

the aim of this randomized controlled clinical study is to evaluate the efficacy of a new piezoelectric technique for wisdom teeth extraction without using manual tools versus the conventional one.Patients referred to the hospital of Bolzano for wisdom tooth extraction will be randomly divided in two groups. In the test group all the procedure will be performed using piezoelectric instruments, while in the control one conventional manual instruments will be used. Main outcome measures are patient pain and complications, secondary outcome measures are duration of the surgical treatment and soft tissue healing

Wisdom teeth extraction can be difficult and patient can suffer post operative swelling and pain. A new piezoelectric technique for wisdom teeth extraction was developed and it showed promising results in terms of surgical effectiveness and patients post operative complications. The aim of the study is to compare the new technique with special designed piezoelectric tools with the traditional one in a randomized controlled way. The same procedures are to be followed for teeth extraction except for the use of a piezoelectric lever in one group and a manual lever in the other one. The study is a mono-center, pragmatic, randomised clinical trial (RCT) of parallel group design. The trial would have one week follow up. All patients referred to the Dental Department of S.Maurizio Hospital (Bolzano, Italy) for the extraction of wisdom teeth are considered eligible for the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for wisdom tooth extraction
* Patients older than 18 years old and able to sign the informed consent

Exclusion Criteria:

* General contraindications to surgery.
* Patients irradiated in the head and neck area.
* Immunosuppressed or immunocompromised patients.
* Patients who took or are taking bisphosphonates intravenously.
* Uncontrolled diabetes
* Presence of oral pathologies that seriously involved oral mucosa
* Patients with poor oral hygiene and motivation.
* Patients with oral pathologies with serious mucosal involvement
* Pregnancy or lactation.
* Addiction to alcohol or drugs.
* Psychiatric problems.
* Patients with an acute infection inflammation around the tooth to be extracted.
* Wisdom teeth with roots attached or positioned around the nerve
* Patients unable to come to the required follow up visits
Acupuncture Effect on Inflammatory Markers in Pediatric Otitis Media With Effusion: A Pilot Study

Objective: to evaluate acupunctures effect on inflammatory markers in pediatric Otitis Media with Effusion Methods: 100 Children with otitis media with effusion (OME) diagnosis, who are in watchful waiting for 3 month, will be randomized in two groups: acupuncture and control. 50 Children in the acupuncture group will receive standard treatment combined with acupuncture for 3 months. 50 Children in the control group will receive standard treatment only, for the same time period. After 3 months, both groups will be reassessed for OME. Children with no improvement from both groups will be assigned for tympanostomy.

Data collection: in children undergoing tympanostomy, middle ear effusion (MEE) will be collected, analyzed and evaluated for group differences.


Eligibility Criteria:
Inclusion Criteria:

* otherwise healthy children ages 2-8 years
* autoscopic OME diagnosis
* tympanometry type B
* conductive hearing impairment of 30 decibel or more
* who are at watchful waiting treatment for 3 months
* signed parental consent.

Exclusion Criteria:

* lack of parental consent
* known coagulopathy
* past tympanostomy
* regular intake of steroids or cytotoxic drugs
Effect of Foot Massage on Postpartum Comfort and Pain Level of the Mothers Who Had Vaginal Birth

Background and Purpose: This study aims to investigate the effect of foot massage in the postpartum period on the need of receiving analgesic medication after assessing the postpartum comfort and pain status of the mothers who had vaginal delivery.Materials and methods: The study was completed with 66 mothers. As data collection tools, a questionnaire, Postpartum Comfort Scale (PCS), Visual Analogue Scale (VAS) and Drug Follow-up Card (DFC) were used.

Background and purpose: This study aims to investigate the effect of foot massage in the postpartum period on the need of receiving analgesic medication after assessing the postpartum comfort and pain status of the mothers who had vaginal delivery.

Materials and methods: In order to keep the number of people in balance between the groups, "block randomization" method which is one of the fixed probability randomization types was preferred. The research was completed with 66 persons, 33 in the study group and 33 in the control group. As data collection tools, a questionnaire, Postpartum Comfort Scale (PCS), Visual Analogue Scale (VAS) and Drug Follow-up Card (DFC) were used.

Research inclusion criteria include (i) primipara mothers (who had their first birth), (ii) mothers who had normal vaginal delivery, (iii) those who had undergone episiotomy, (iv) who were volunteered to participate in the study, (v) who were on the first day of delivery (first 24 hours), (vi) who had no complications in the infant and the baby, (vii) age of whom ranged from 18 to 35, (viii) those who did not apply or receive any other complementary therapy, (ix) mothers who did not have any wound, infection or discomfort etc. on their feet, and those who can read and write.

Eligibility Criteria:
Inclusion Criteria:

* primipara mothers (who had their first birth),
* mothers who had normal vaginal delivery,
* those who had undergone episiotomy,
* who were volunteered to participate in the study,
* who were on the first day of delivery (first 24 hours),
* who had no complications in the infant and the baby,
* age of whom ranged from 18 to 35,
* those who did not apply or receive any other complementary therapy,
* mothers who did not have any wound, infection or discomfort etc. on their feet,
* mothers who can read and write

Exclusion Criteria:

* mothers with any systemic disease
* mothers who dislike foot massage during practice
* early discharge mothers
* mothers who applied another massage technique
* mothers who take the analgesic drug unnecessarily
Specially Designed Eating Plates Effects on Food Intake in Normal Weight and Overweight Children

Previous studies demonstrated that children served themselves more food when using larger plates and bowels. The purpose of this study is to evaluate if self-served portions and caloric intake in normal weight and overweight children will be influenced by a specially designed eating plates compared to similar size normal plates.

40 normal weight and 40 overweight kindergarden and elementary school children will participate in this study.

Anthropometric measurements: weight, height, BMI and BMI percentiles will be measured and calculated for each participant.

The participants will take part in two non-exercise activities at the 'sport and health center for children and adolescence'. At the end of each activity, a lunch buffet that contains all food ingredients will be served. During one meeting the children will be handed a regular plate and at the second meeting they will be handed a specially designed plate (with marking of the recommended meal composition and portion).

The amount and composition of food on the plates will be assessed by weighing and photography before and after eating and analysed to report macronutrient consumption by a dietitian. The meetings for normal weight children will be separated from the overweight children.

Eligibility Criteria:
Inclusion Criteria:

* Over weight / obese children
* Normal weight children

Exclusion Criteria:

* Organic disease that cause obesity
* Underweight children (BMI percentiles \< 5)
Motivational Interviewing Intervention for Intimate Partner Violence

This project is a randomized trial to determine if motivational interviewing (MI) is an effective intervention to help women in abusive intimate relationships. The study objective is to motivate abused women to identify and achieve their own specific goals that can help them address the violence in their lives. This project will be integrated into the setting of a busy family planning clinic in the mid-western United States, which serves a largely rural population. Intimate partner violence (IPV) is screened using the Women's Experience with Battering Scale (WEB), a modified Abuse Assessment Screen (AAS), and the Danger Assessment Screen (DAS). An expected 250 women who screen positive for IPV will be enrolled, randomized to the intervention or to usual care group, and complete the 6-month study protocol. All subjects complete a self-administered computer-based questionnaire at the initial and 6-month follow up visits to measure self-efficacy (primary outcome), stage of readiness to change, selected IPV-related health correlates (e.g., depression), and steps taken and resources used. The MI intervention is an "active listening" counseling technique aimed at guiding the patient towards identifying feasible, personalized goals and steps she can take to increase her self-efficacy and control in the relationship. The trained study interviewer will work with participants to identify steps they can safely take and local resources to help them meet their goals. The MI protocol consists of a face-to-face counseling session at baseline with follow-up telephone interviews conducted at 1-, 2-, and 4-months post-intervention to reinforce the intervention and assess the participants' level safety. The control group will receive usual care, which includes talking with a Level 3 Domestic Violence Advocate and receiving a comprehensive list of domestic violence resources. Effectiveness of the MI intervention will be determined by increased self-efficacy, measured by the Domestic Violence Coping and Self-Efficacy Scale, a validated tool for use among women with a recent history of domestic abuse; and by a reduction in depressive symptoms (CESD-10). The impact of the intervention will be assessed by an increase in participants' readiness-to-change, and extent of their involvement in a wide variety of self-help and coping activities over the follow-up period. If successful, this screening and intervention program will be translated to other clinical settings.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Screens positive for IPV
* Literate in either English or Spanish

Exclusion Criteria:

* Less than 18 years of age
* pregnant at time of screening and consent
Bone Health in Adolescents and Young Adults With Oral Macro-progestin Treatment

Many factors are known to influence the acquisition of bone capital, especially estrogens in women. Estrogens have a major role in bone growth and the acquisition of bone mass peaks during puberty. This peak of bone mass is an important determinant of the risk of osteoporotic fracture in adulthood.

It is known that estrogen deficiency increases the rate of bone remodeling and engenders an imbalance between resorption and bone formation, which can lead to osteoporosis.

Oral estroprogestin contraceptives have an anti-gonadotropic effect and suppress estrogen secretion by the ovaries.

However, studies in adolescents and young adults are rare and evidence of an effect on bone is still inconclusive, although there is increasing evidence that oral estroprogestin contraceptives in teenage girls may compromise the performance of the bone mass.

Macro progestins treatments are prescribed in France to patients with contraindications to estroprogestin treatments. This practice is french and few recommendations exist on the use of these molecules by the oral route. There are no studies that describe the impact of these oral treatments on the bone health of young women treated.

The Department of endocrinology, gynecology and pediatric diabetes of Necker-Enfants Malades hospital, follows many young girls taking a macro progestin treatment. This study is exclusively descriptive and will focus on the clinical and medical datas available on the bone health of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 16 to 25 years old
* Patients followed at Necker-Enfants Malades hospital
* Patients who have taken or taking macro-progestins treatment by oral route (Luteran, Lutenyl, Surgestone) for at least 6 months between the age of 16 and 25 years

Exclusion Criteria:

* Patients with a pathology or treatment that can alter bone mineral density
Esophageal Echo Assessment of LV Function During Acute Normovolemic Hemodilution Using Crystalloid or Hypertonic Saline

The purpose of this study is to examine how the heart functions when a calculated amount of blood is removed and how two fluids, Lactated Ringer's (considered the standard replacement fluid) and Hypertonic Saline, re-expand the vascular system.

This investigator-initiated, single-center, prospective, randomized, clinical experimental design will enroll 30 patients scheduled for elective radical prostatectomy, cystectomy, or cystoprostatectomy, and anterior/posterior spinal fusions, which includes routine acute normovolemic hemodilution (ANH) as a technique to decrease the need for banked blood transfusions. The purpose of this study is to compare two methods of volume replacement during the ANH procedure. Patients will be randomized to receive either standard crystalloid replacement with Lactated Ringers (LR) or 5% hypertonic saline. Selected measurements will be obtained by transesophageal echocardiography (TEE) for assessing changes in left ventricular volume and function associated with blood loss and replacement. This study will use the Accuson Cypress Cardiovascular System and the V5M transesophageal echocardiography probe (Siemens Medical Solutions, Malvern, PA). The TEE measurements will be recorded on magnetic optical discs and assessed off-line by the researcher after the data collection is completed using the proprietary software included in the ultrasound system. In addition, stroke volume variation measurement (SVV), Cardiac Output (CO), Cardiac Index (CI), and Stroke Volume Index (SVI) will be measured using the Vigileo (TM) arterial pressure monitor with the FloTrac (TM) sensor (Edwards Lifesciences, Irvine, CA).

Eligibility Criteria:
Inclusion Criteria:

* Elective surgical patients requiring acute normovolemic hemodilution

Exclusion Criteria:

* Contraindication for hemodilution
* Contraindication for TE echo
Evaluation of Continuity of Care at a Health Service Organization

This project was conducted with patients at a multi-disciplinary, multi-specialty health services organization serving 44,000 rostered patients in Northern Ontario. It investigated continuity of care for patients with diabetes in the areas of barriers and potential solutions to, and correlates of continuity; and variability in costs associated with continuity of care and patient outcomes.

Continuity of care is a concept that has been garnering increased attention in the last few years. There have been multiple methods proposed by researchers for measuring continuity of care, most of which are based on proportions or ratios of visits to the same health care provider or centre. While a consistent method for measuring continuity of care is lacking, increased continuity of care using various definitions and measurement tools has been related to better well being, lower health care costs, better glucose control, and higher satisfaction but has also not been found to improve health outcomes in other scenarios. Whether a patient is better served by high sequential access to one provider or any provider within the same system or management team is controversial. Finally, patients' perceptions of continuity of care have not been generally evaluated or correlated with current measurement methods. This project was conducted with patients at the Group Health Centre in Sault Ste Marie, Ontario, a multi-disciplinary, multi-specialty health services organization serving 44,000 rostered patients

Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years)
* Diagnosis of diabetes mellitus (according to the definition used in 1999 by the Canadian Diabetes Association

Exclusion Criteria:

* Gestational diabetes
* Could not communicate in English
* Life expectancy or residency expectancy in Sault Ste Marie of less than three years