cyrilzakka/clinical-trials huggingface dataset:
Comparison of Bupivacaine Wound Infiltration Versus Wound Instillation to Minimize Postoperative Pain After Thyroid Surgery

Pain management following thyroidectomies, which can cause mild to moderate postoperative pain, particularly in the first 24 hours following surgery, has received little attention . The incision of the wound, neck hyperextension, retraction of the wound margins during surgery, and dissection are the main reasons of post-thyroidectomy discomfort . After thyroid surgery, pain management improves patients' quality of life and facilitates a speedy return to regular daily activities.

the aim of the study to evaluate the effects of bupivacaine instillation after thyroidectomy against infiltration into the surgical field in order to reduce postoperative discomfort following thyroid surgery.

Pain management following thyroidectomies, which can cause mild to moderate postoperative pain, particularly in the first 24 hours following surgery, has received little attention . The incision of the wound, neck hyperextension, retraction of the wound margins during surgery, and dissection are the main reasons of post-thyroidectomy discomfort . After thyroid surgery, pain management improves patients' quality of life and facilitates a speedy return to regular daily activities.

Eligibility Criteria:
Inclusion Criteria:

* Normal thyroid function patients of both genders scheduled for thyroid surgery will included in this study
* If they are over the age of 18
* If they had an ASA score (American Society of Anesthesiology) I, II.
* A Score of Mallampati I , II.

Exclusion Criteria:

* Patient refused to participate in the study.
* Patients will be excluded if they have any analgesic medication or corticosteroid drug prior surgery or
* A known or suspected allergy to local anesthetics,
* if the duration of surgery is greater than 5 h and if a major complication of surgery or anesthesia (major bleeding, allergy to anesthetic products).
* Patients who have lateral neck dissection associated with Thyroid surgery are excluded.
Reproductive Health Program in Patients With Cancer

This clinical trial studies reproductive health program in patients with cancer. A reproductive health program may improve patients' understanding of reproductive risks and receipt of appropriate treatment to achieve their reproductive health goals.

PRIMARY OBJECTIVES:

I. To evaluate the success of the implementation of reproductive health programming (Didactics, Engendering Reproductive Health Within Oncologic Survivorship \[EROS\] Reproductive Health Assessment and EROS Trial Algorithm) among reproductive aged females (15-55) with cancer.

SECONDARY OBJECTIVES:

I. To assess the degree of discrepancy between patients and their clinicians in estimates of significance of the reproductive health goals for the patient.

II. To evaluate baseline and follow-up reproductive health assessments for trends in reproductive health choices relating to oncofertility, oncocontraception and pregnancy over the 2-year study period.

III. To identify clinical and demographic factors that predict the adequacy of reproductive health care management.

TERTIARY OBJECTIVES:

I. To perform a longitudinal study following endocrine markers of fertility in a cohort of the first 200 registered EROS trial patients who agree to participate.

II. To perform a longitudinal study of sexual function using the Patient-Reported Outcomes Measurement Information System (PROMIS) sexual function survey in all subjects participating in the EROS Trial.

OUTLINE: Participating institutions are randomized to 1 of 2 arms. Patients are assigned to a study arm depending on the institutional assignment.

ARM A: Patients undergo usual standard practice related to reproductive health. ARM B: Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.

After completion of study intervention, patients are followed up periodically.

Eligibility Criteria:
Inclusion Criteria:

* Female patients presenting with initial diagnosis of any type of cancer, including patients with ductal carcinoma in situ (DCIS)
* Pre-menopausal patients within the reproductive age range of 15-55 years; pre-menopausal is defined as females meeting the following criteria:

  * Patients not currently on hormonal contraception with the presence of menses in the past 6 months
  * If no menstruation in the past 6 months, without hormonal manipulation, then confirmed follicle-stimulating hormone (FSH) \< 23mlU/mL
  * If age \< 47 years and on hormonal contraception, then patient will be eligible regardless of menstrual history
  * If age ≥ 47 years and on hormonal contraception, then FSH confirmed \< 23mIU/mL
* Pregnant women are eligible to participate in this study
* Patients must have the cognitive ability to participate in the study

Exclusion Criteria:

* Patients who have initiated chemotherapy, radiation therapy or endocrine therapy prior to registration to this study
* Prior hysterectomy, bilateral oophorectomy or sterilization of any method
Web and Phone Intervention to Maintain Postpartum Tobacco Abstinence

This study seeks to develop and test a Web-based tobacco relapse prevention program targeting postpartum women who quit smoking for pregnancy. Participants are randomly assigned to one of two conditions: (1) an Enhanced Web+phone Condition that receives access to an interactive Web-based intervention plus up to 3 brief supportive phone calls from a personal coach; (2) A Basic Web Information-Only Control Condition that receives access to an informational website plus an introductory phone call. The hypothesis is that Women in the Enhanced Condition will be more successful in avoiding tobacco relapse than women assigned to the Basic Control Condition.

The primary aims of this project are to:

1. Adapt and refine an Enhanced Web+phone intervention for the maintenance of tobacco abstinence postpartum.
2. Evaluate the feasibility and acceptability of the Enhanced Web+phone tobacco abstinence maintenance program for postpartum women.

   Aim 2.1 The investigators hypothesize that the intervention will be feasible as assessed by women's report of helpfulness, relevance and program usability.

   Aim 2.2 The investigators hypothesize that the intervention will be acceptable to postpartum women as measured by engagement in and use of the program.
3. Estimate the initial efficacy of the Enhanced Web+phone intervention on tobacco abstinence at 3 and 6 months postpartum relative to a Basic Web Information-Only control.

Aim 3.1 The investigators hypothesize that, relative to the Basic Web Information-Only control, the Enhanced Web+phone intervention will be associated with 10-points greater prolonged abstinence rates at 3 and 6 months postpartum.

Aim 3.2 The investigators hypothesize that, relative to Basic Web control, tobacco use outcomes at 3 and 6 months postpartum in the Enhanced Web+phone intervention will be associated with greater improvements (d \> .35) in putative mediators of prolonged abstinence (i.e., self-efficacy, intentions to maintain nonsmoking, mood and perceived stress, and weight concerns).

Secondary aim of this proposal is to:

Evaluate potential predictors of postpartum smoking relapse. The investigators will examine pre-pregnancy smoking rate, partner's tobacco use and other demographic factors as predictors of postpartum tobacco relapse. Similarly, the investigators will examine the role of mood, perceived stress and weight concerns as predictors of prolonged abstinence among women in both groups. For example, it may be that women with higher baseline levels of depressive symptoms and perceived stress may be more likely to return to smoking postpartum, regardless of condition.

Eligibility Criteria:
Inclusion Criteria:

* Smoked at least 5 cigarettes/day for at least 1 of the 3 months prior to becoming pregnant
* No smoking during weeks 34 to 38 of pregnancy
* Able to read English
* At least 18 years of age
* Use Web e-mail account at least once per week
* Completed informed assent/consent.
Efficacy of Teeth Whitening Product Offerings in Adults

This is a 30 day randomized, parallel comparative trial where participants with tooth shade of C2 or darker will be assigned to one of five groups. The participants will be evaluated for the difference in tooth shade, as determined by the digital VITA Easyshade V (provided by GLO) before the respective whitening regimen (baseline), immediately following the treatment period, and at 30 days (\~4 weeks) from end of the treatment intervention.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent to participate in the study.
* Be 18 to 65 years of age.
* Agree not to participate in any other oral/dental product studies during the trial.
* Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed.
* Agree to refrain from the use of any other teeth whitening products once assigned to a treatment group.
* Agree to refrain from the use of any oral care products that may cause staining (chlorhexidine rinses, stannous fluoride toothpaste, etc.).
* Agree to return for all scheduled visits and follow study procedures.
* Be in good general health, as determined by the investigator/designee based on a review of the health history/update for participation in the study.
* Have at least 4 gradable maxillary anterior teeth ( canine to canine) with a Vita Shade average score of C2 or darker.
* Be willing to refrain from consuming stain-causing food and beverages (i.e., coffee, tea, red wine, berries, etc.) during the initial treatment duration (treatment period excluding the 4 week follow up).
* Be a current or recent non-smoker (no smoking for at least 3 months).

Exclusion Criteria:

* Are undergoing treatment for gingivitis, periodontitis, or caries.
* Presence of self-reported tooth sensitivity.
* Present with fixed orthodontic appliances on the facial surfaces of the maxillary arch.
* Have dental crowns, veneers or composite restorations on gradable maxillary anterior teeth ( canine to canine) or mandibular anterior teeth.
* Have any oral pathologies or gross neglect of home care requiring prompt treatment, including periodontal disease, as evidenced by purulent exudate, exposed root surfaces (generalized recession), tooth mobility, and/or other signs indicating that the integrity of the data collected for that subject might be compromised.
* Present with any pre-existing oral or medical condition that the Investigator/designee determines may place the subject at increased health risk from study participation.
* Have meaningful malocclusion that would impact treatment or ease of viewing/scoring maxillary anterior teeth.
* Have teeth with severe or atypical intrinsic staining, such as that caused by tetracycline, fluorosis or hypocalcification.
* Have any known allergies to over-the-counter oral hygiene/whitening products.
* Have any known allergies to the trial product ingredients.
* Are pregnant and/or breastfeeding.
* Are current smokers.
RENAL RESISTIVE INDEX POST-OPERATIVE COMPLICATIONS IN MAJOR SURGERY?

An observational trial aiming to verify whether does any relationship exist between renal resistive index and postoperative outcome in major high risk surgery

Renal resistive index was measured just after major high risk operations and then patients were observed searching for any surgical and medical-related complications during the first post-operative week

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* major surgical operations

Exclusion Criteria:

* age \< 18 years
DHEA Bioavailability Following Administration of Vaginal Suppositories in Post-Menopausal Women With Vaginal Atrophy

The purpose of the study is to evaluate the systemic bioavailability of DHEA and its metabolites and the pharmacokinetics of vaginal suppositories at four different DHEA concentration.

Humans, are unique among animal species in having adrenals that secrete large amounts of the inactive precursor steroids dehydroepiandrosterone (DHEA) and especially its sulfate DHEA-S. The marked reduction in the formation of DHEA-S by the adrenals during aging results in a dramatic fall in the formation of androgens and estrogens in peripheral target tissues, a situation that has been proposed to be associated with age-related diseases including skin atrophy, insulin resistance and obesity. Much attention has been given to the benefits of DHEA administered to postmenopausal women, especially on the bone, skin, vagina and well being after oral as well as percutaneous administration of the precursor steroid.

Therefore, this study proposes to evaluate the systemic bioavailability and the effectiveness of 1.3 mL vaginal suppositories of DHEA at 4 different concentrations (0.0%, 0.5%, 1.0% et 1.8%) following 1 week administration of vaginal suppositories in post-menopausal women with vaginal atrophy. This is a phase I, randomized, placebo-controlled, double-blind study.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women,
* Experiencing one symptom of vaginal atrophy (vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity or vaginal bleeding associated with sexual activity,
* Women having a low maturation index and a vaginal pH above 5,
* Endometrial thickness of 4 mm or less at transvaginal ultrasonography,
* Body weight within 18.5 and 32.0 according to body mass index.

Exclusion Criteria:

* Undiagnosed abnormal genital bleeding,
* Active or history of thromboembolic disease,
* Significant metabolic or endocrine disease,
* Significant complication on previous hormonal therapy,
* Use of hormonal implants within 6 months prior to study entry,
* Use of oral estrogen, progestin or DHEA in the 8 weeks prior to baseline,
* Use of natural (phytoestrogens) or herbal products in the 2 weeks prior to baseline,
* Chronic use of corticosteroids,
* Hypertension not controlled by standard therapy.
Fatty Liver in Pregnancy

Non alcoholic fatty liver disease (NAFLD) is one of the main causes of development of chronic liver disease and cirrhosis. There are no published studies which have investigated the incidence of NAFLD in pregnant women or the correlation between the metabolic changes in pregnancy and this phenomenon.

We aimed in our study to explore the incidence of NAFLD in pregnancy by ultrasonography (US) during the end of the pregnancy or immediately after birth (after 36 weeks) and to look for a correlation between fatty liver and demographic, clinical, nutritional and laboratory data during pregnancy.

Fatty liver in pregnancy-protocol:

Non alcoholic fatty liver disease (NAFLD) is one of the main causes of development of chronic liver disease and cirrhosis. The incidence of NAFLD among the general population is about 17-30%. There are no published studies which have investigated the incidence of NAFLD in pregnant women or the correlation between the metabolic changes in pregnancy and this phenomenon.

We aimed in our study to explore the incidence of NAFLD in pregnancy by ultrasonography (US) during the end of the pregnancy or immediately after birth (after 36 weeks) and to look for a correlation between fatty liver and demographic, clinical, nutritional and laboratory data during pregnancy.

Methods: US examination will be performed by an experienced technician. The liver will be scanned by B mode US using a 2-5 MHZ transducer. In those with fatty liver as seen by US, a repeat examination will be performed after 6 weeks and 24 weeks. For women with the diagnosis of fatty liver, serum lipid profile, glucose, liver function tests and insulin will be done. Homa score as well as BMI will be calculated for each woman with fatty liver. All participants will sign an informed consent which has been approved by the hospital ethical committee.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women during the end of the pregnancy or immediately after birth (after 36 weeks)

Exclusion Criteria:

* Pregnant women before 36 weeks of pregnancy.
* Known diabetes or treatment by drugs known to cause fatty liver.
Randomized Controlled Trial of the Effectiveness of Perineal Pain and Security of the Suture Led by the Result of Hemostasis Versus Manual Compression Routine Suture Perineal Tears of First Degree During Childbirth

During childbirth, the recommendations have evolved to a restriction of episiotomy. This reduction results in an increase of superficial vaginal and perineal tears. These lesions are usually routinely sutured which often causes the onset of discomfort and pain in the immediate postpartum period. Gordon showed, in 1998, improved comfort and pain when the skin was not sutured perineal tears during the second degree. Others have compared different techniques in the same indications (separated points running suture, biological adhesive) without demonstrated impact. These studies were not interested in isolated perineal tears or first degree or the application of a simple manual compression with or without a suture according to the result of hemostasis.

Our objective is to evaluate the possibility of not suture the perineum of the first degree. The use of suture only result of bleeding not yielding to manual compression.

Our approach is guided by the principles of "primum non nocere" and discerning about the dogmatic systematization.


Eligibility Criteria:
Inclusion Criteria:

* single Pregnancy
* primiparae
* delivery by spontaneous vaginal delivery
* forward Delivery (≥ 37 weeks)
* cephalic presentation
* children living
* perineal tear or isolated first-degree vaginal tear

Exclusion Criteria:

* Known haemostatic anomaly
* Premature birth (before 37)
* caesarean
* Instrumental delivery
* Placenta and / or uterine revision
* episiotomy
* perineal tear ≥ 2nd degree
Investigation of the Effectiveness of Resistance Exercise Program Given With Diet in Obese Individuals.

The aim of this study is to examine the effects of diet and combined resistance exercise training on physical activity and sleep patterns compared to diet program alone.

The study was planned as a randomized controlled trial. The groups will be divided into two as control group and exercise group by simple randomization method.While the normal diet program will be applied to the obese individuals in the control group, the individuals in the exercise group will be given resistance exercise training together with the diet program.Before and after the treatment, fatigue severity scale pittsburgh sleep quality scale international physical activity index questionnaires will be applied to the participants.In addition, sociodemographic characteristics and waist circumference measurement will be recorded. After the 12-week diet program, the data of the participants will be compared by making statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* be 18 years or older.
* Having a Body Mass Index of 30 or higher.
* To have accepted the voluntary consent form that requires participation in the study.

Exclusion Criteria:

* Any neurological or psychological problems.
* Do not accept the voluntary consent form.
A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004669)

Evaluate the injections of Ji Gami(TM) and Ji Gami(TM) DO, where cells are expanded ex vivo from scalp, to induce hair growth in male and female subjects with hair loss.


Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers 18 to 65 years old, inclusive
* Hair loss consistent with ≥ Grade III-Vertex, IV, VA, V, and VI, based on Norwood-Hamilton Scale providing there is bridging of hair in the anterior edge of the vertex circle.
* Have no clinically significant disease or abnormal laboratory results taken at the screening visit.
* Agree to abstain from use of any hair growth affecting oral or topical medication including over the counter and herbal medications, minoxidil, finasteride or dutasteride during the course of this study.

Exclusion Criteria:

* Known sensitivity to DMEM/F-12 or any component of the study material.
* Known hypersensitivity to clindamycin hydrochloride, amphotericin B or streptomycin sulfate.
* Subjects who have used minoxidil, or any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 6 months of study screening, or finasteride or dutasteride within 12 months of study screening.
* A history of drug or alcohol abuse within 1 year of study enrollment.
* Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator.
* Any clinically significant abnormal laboratory parameters.
* A positive result at screening for human immunodeficiency virus (HIV 1 or 2), Hepatitis B or C, HTLV I/II.
* Dermatologic condition in donation or study areas.
* Prior surgery in the treatment area.
* Insufficient hair or scarring in the donor area that might impact cell growth.
* Any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that would place the subject at increased risk.
The Effect of Vitamin D3 Therapy in Post Menopausal Women and Assessment of Changes in Bone Mineral Density After Orally Vitamin D3 Administration

a study design based on vitamin D deficiency in postmenopausal women with low bone density. pre-test for BMD will be done then vitamin D oral supplements will be provided for the period of 3 months. Post-test of BMD will explore the results.

Sample description Study Design Randomized Control Trial. Settings OPD patients Duration 8 months Sample size 200 Masking Single blind (only Participants) Study subjects Routine visit OPD patients with orthopedic problems Sampling techniques RCT will be done by giving vitamin D (pre-test and post-test of BMD will be done .

Inclusion Criteria Female patients above 50 years (Post-menopausal) Exclusion Criteria All other women Study variables : Independent: Vitamin D Data collection will be done through randomized control trial. Patient with age above 50 years female, with menopausal changes. The BMD test will be done in all participants either placebo or actual treated patients to check the effect of vitamin D3 therapy. Treatment plan includes vitamin D3 at 50,000 International Units daily for 15 days then two times a month for four months along with dietary changes which will consider high dose D3 therapy, and low dose vitamin D3 therapy includes dietary changes along with 1000 international units of Vitamin D3 tablet form. Daily white placebo pills to other group of participants. Bone Mineral Density will be observed through pre-test and Post-test.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal Women

Exclusion Criteria:

* All other women