cyrilzakka/clinical-trials huggingface dataset:
Assessing Women's Attitudes About the Risk of Infertility Related to Adjuvant Therapy for Early Breast Cancer

RATIONALE: Adjuvant therapy given after surgery for early breast cancer may cause infertility. Assessing young women's attitudes and feelings about the risk of infertility may help improve the ability to plan effective treatment.

PURPOSE: This clinical trial is studying young women's attitudes and feelings about the risk of infertility related to adjuvant therapy for stage I or stage II breast cancer.

OBJECTIVES:

* Determine the attitude toward the risk of infertility related to adjuvant therapy in women with early breast cancer.
* Correlate, if possible, the patient's attitude with the fact that the patient already has children or the time interval between the date of breast cancer diagnosis and the date of study participation.

OUTLINE: This is a multicenter study.

Patients complete a questionnaire administered by a nontreating physician.

PROJECTED ACCRUAL: A total of 385 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed prior or current diagnosis of breast cancer

  * Stage I or II
  * No relapsed disease
* No evidence of infertility

  * Regular menses or regular hormonal contraception use for the past 3 months
* Hormonal status:

  * Not specified

PATIENT CHARACTERISTICS:

Age

* 35 and under at diagnosis

Sex

* Female

Menopausal status

* Premenopausal

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* No psychological, familial, sociological, or geographical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* See Disease Characteristics

Radiotherapy

* Not specified

Surgery

* Not specified
"Mantou" Screening for GDM Before 20 Weeks of Gestation

Gestational diabetes mellitus (GDM) can occur in overweight, hyperinsulinemia, insulin resistance pregnant women, or lean, insulin deficiency pregnant women. At least 5% of all pregnant women will develop GDM, which is even higher among Asians. Poor control of GDM in late pregnancy will increase the following risks: macrosomia, preeclampsia, shoulder dystocia, cesarean section, stillbirth and other risks. At present, the screening method for GDM is 75g of glucose OGTT test. However, when drinking sugared water on an empty stomach, the pregnant women will feel nausea, stomach burning, and hunger when waiting for blood drawing. Some women vomit after drinking sugared water, resulting in inaccurate test results and poor compliance, affecting the accuracy of diagnosis of GDM. "Sugar tolerance Mantou" has been used for screening diabetes since 1982. It is made of 100g flour and contains 75g glucose of the same amount. It is a feasible method to use Mantou instead of sugar powder to screen GDM. Mantou is an acceptable diet for Chinese people, which greatly reduces nausea, vomiting, hunger and other discomfort, and increases GDM screening rate. At present, the cesarean section rate in China remains high, and the weight and nutritional management of pregnant women are not satisfied. Many pregnant women, especially those in country-level areas, have already gained excessive weight when referred from to delivery hospitals, leading to an increase in pregnancy complications such as preeclampsia and macrosomia, increasing the cesarean section rate and delivery risk. Therefore, it is necessary to screen GDM in advance. Moving forward the screening of GDM and strengthening the management of pregnant women's weight can effectively reduce the occurrence of pregnancy complications.


Eligibility Criteria:
Inclusion Criteria:Singleton , before 20 weeks of gestation, aged 18-40 years old, able to understand the experimental requirements, willing and able to follow the experimental and follow-up procedures.

Exclusion Criteria: diabetes diagnosed before pregnancy, serious heart disease, blood disease, immune system disease and other unsuitable for pregnancy, twin or multiple pregnancy, age\<18 or\>40, fetal death in utero before 28 weeks, serious mental illness, and inability to communicate.
Laparascopy Versus Laparatomy in the Management of Ruptured Ectopic Pregnancy

Standard management for patients with ruptured ectopic pregnancies at our institution is treatment by laparotomy. This trail will investigate the feasibility of treatment with laparoscopy and will look at outcomes such as hospital stay and pain experienced

The hypothesis is that laparoscopy is a feasible treatment option associated with shorter hospital stay and less pain

Laparoscopic surgery for the surgical management of women diagnosed with ectopic pregnancies has become the standard of care in many institutions around the world. Laparotomy is still the standard of care at Kalafong Hospital. There is very little high quality evidence with regard to the optimal surgical management approach for women with ruptured ectopic pregnancies.

The study aims to compare laparotomy with laparoscopy in this group of women with regards to outcomes such as length of hospital stay, number of days off work and pain.

This randomised study will be conducted at Kalafong hospital, on 140 patients diagnosed with ruptured ectopic pregnancy who are haemodynamically stable and are able and willing to provide informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Able to give informed consent
* must have two of the following three:
* systolic blood pressure \>90 mmHg
* pulse rate \<100 beats per minute
* heamoglobin \>8 g/dL

Exclusion Criteria:

* \<18 years
* haemodynamically unstable
* not able to give informed consent
Sound Perception Study of Hearing-impaired People With Hearing Aids

The aim of the ETERNEL project will be to study the influence of the perception of a single sound timbre on the understanding of a complex sound scene in hearing-impaired people with hearing aids. This will be done by quantifying the inability to manage a complex sound scene as a function of the timbre of the sounds making it up. The more a sound interferes with understanding the complex sound scene, the more salient that sound is considered to be. In this way, the investigators can determine which timbre dimensions make sounds particularly salient for the hearing impaired.


Eligibility Criteria:
Inclusion Criteria:

For all participants:

* Age between 60 and 75
* Native French speaker
* Have given their consent to take part in the study.
* Declare that they have an active social life or hobbies that stimulate their cognitive abilities
* Have a MOCA score above 26
* No tympano-ossicular dysfunction.
* Voice in noise audiometry results showing normal results.

For participants with impaired hearing :

* Pure tone audiometry showing audiograms of type N3 or N4 and symmetrical between the two ears.
* Report having experienced problems with abnormally prominent sound.

For participants with normal hearing:

- Pure tone audiometry showing audiograms with losses of less than 30 dBHl.

Exclusion Criteria:

* Be under guardianship or curatorship,
* Be deprived of liberty by judicial or administrative decision, or be under legal protection.
* Bear the consequences of an ear infection and/or have a history of an ENT disease that permanently affects hearing or balance (vestibular schwannoma, Ménière's disease, sudden or fluctuating deafness, congenital hypoacusis).
Anatomical Classifications of Henle's Trunk

Right colon has complicated anatomy which is surrounded by important organs. The variations of vessels are more frequent than in left colon, which contribute to the difficulty of surgery. Among the variations, Henle's trunk is more obvious that makes it the commonest cause of bleeding during operation. Several veins can be found to conjoin the Henle's trunk, among which ASPDV and REGV are the two common tributaries while RCV,MCV,SRCV may vary from people to people. As a result, a better understanding of the anatomical classification of Henle's trunk is a must during operation. However, existing studies of Henle's trunk are very rare and often single-centered with minimal samples.In order to achieve better surgical outcome and reduce operative complications, the investigators design this study to investigate the anatomical classification of Henle's trunk and the surgical outcome of each type.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who undergoing laparoscopic right hemi-colectomy with D3 lymphadenectomy
2. Pathology: adenocarcinoma or high-grade intraepithelial neoplasia proven by colonoscopic biopsy.
3. Localization: tumor located between cecum and proximal 1/3 portion of transverse colon.
4. Patients have to be aware of the aim of the trial, and have signed the informed consent.

Exclusion Criteria:

1. History of any gastrointestinal surgery.
2. Patients with ileus, perforation, bleeding and any other conditions required of emergent surgery.
Morbid Obesity and Severe Knee Osteoarthritis - Which Should Be Treated First?

The goal of this study is to determine whether undergoing bariatric surgery before knee replacement leads to better outcomes compared to undergoing knee replacement before bariatric surgery. Our secondary goal is to compare complication rates between these groups to determine if there is a difference based on the order of the two procedures.

Participants will be randomly placed in one of two groups, with each undergoing both procedures but in opposite order. Quality of life will be assessed via questionnaires before and between each procedure, and rates of complications will also be documented to compare their rates between groups.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> or = 35, on surgical waitlist for a total knee arthroplasty and laparoscopic sleeve gastrectomy

Exclusion Criteria:

* a history of revision surgery, surgery for neoplastic disease, significant mental illness, ASA class \> 3 denoting absence of significant impact of comorbidities, and previous esophagogastric surgery.
Effects of Exercise Therapy Adjuvant Device on Head and Neck Cancer Patients in the Treatment of Cancer Therapy Induced Trismus

Trismus is traditionally considered being a late effect of cancer therapy with functional deficits becoming clear in the first year after completing radiation therapy. These deficits can rapidly progress to a state of functional impairment. The most common treatment for trismus is physical therapy comprising an active range of motion (ROM) exercises, hold and relax techniques. Once trismus has developed, it may be hard to reverse. Thus, prevention with a program of self-care is important for managing this side effect. This study want to test the effect with adjunctive devices plus exercise to prevent trismus.


Eligibility Criteria:
Inclusion Criteria:

1. Age is greater than or equal to 20 years old.
2. Those who are able to communicate in Mandarin and Taiwanese and have no reading or listening or writing disabilities can fill out the questionnaire by themselves or with the assistance of the researcher.
3. Diagnosed with head and neck cancer, and is expected to receive head and neck radiation therapy for the first time.
4. A clear consciousness, no severe cognitive impairment or mental symptoms.
5. Willing to participate in this research and obtain consent.

Exclusion Criteria:

1. People with known temporomandibular joint disorders.
2. The maximum opening degree is less than or equal to 25 mm.
3. Those who have received radiotherapy for the head and neck in the past.
4. Those who have been diagnosed by a physician for poor wound healing after surgery and unable to perform mouth-opening rehabilitation exercises.
A Pragmatic Trial of Chronic Disease Approaches to Ameliorate Tobacco Related Cardiovascular Disease Health Disparities

This project will evaluate a proactive outreach intervention for tobacco cessation among primary care BIPOC populations who smoke in two health systems across the region. Compared with Whites, BIPOC populations in the US experience disproportionate health consequences from commercial cigarette use. Few evidence-based cessation treatments (EBCTs) have been specifically developed, evaluated, or implemented for BIPOC populations. Moreover, uptake of EBCT (e.g. medication, counseling) is lower among BIPOC populations. Reasons for the failure to engage BIPOC patients in EBCTs are complex and multi-level (e.g., patient, provider, healthcare system). To address these gaps, the investigators will assess the added effectiveness of an approach to augment the standard of care with longitudinal proactive outreach to connect BIPOC adults with EBCT. The proposed multi-level intervention leverages the electronic health record to identify patients who smoke, who can then be proactively engaged via culturally tailored outreach to connect them to EBCT. The proactive approach may circumvent experiences of bias within the healthcare system and thus enhance engagement.


Eligibility Criteria:
Inclusion Criteria:

* English or Spanish-speaking BIPOC patients within the Hennepin Healthcare or MCHS system. BIPOC patients are any patients with a chart identified race that is not White, and will be verified by self-report from the baseline survey.
* Currently smoke \>1 cigarette over the past 30 days
* Must have address or telephone number in the electronic health record

Exclusion Criteria:

* Electronic health record documented cognitive impairment or legal guardianship
* Patients who have opted out of reserach studies
Management of Thyroid Function in Hashimoto's Thyroiditis During Pregnancy

The management of thyroid function in pregnancy has been object of several guidelines in the last years. Normal thyroid function reduces prenatal and post-natal risks and gestational complaints. Trimester specific reference values of thyroid hormones and thyroid stimulating hormone (TSH) are available for selected geographic population but its are not yet are available in our country. Hashimoto's thyroiditis (HT) is the most frequent autoimmune thyroid disease which can induce thyroid dysfunction, mainly sub-clinical hypothyroidism. Due to the large incidence in women HT and its potential link with thyroid dysfunction this disease could be search and monitored before pregnancy. Anyway a strong recommendation is to test TSH levels in all patients seeking pregnancy at risk for thyroid dysfunction for a history or current symptoms/signs of thyroid dysfunction, known positivity od thyroid autoimmunity or goiter, a history of neck radiation, age \>30 years, diabetes mellitus, previous infertility or pregnant loss, morbid obesity, living in area of moderate-severe iodine deficiency or recent administration of drugs/substance interfering with thyroid function.

The aim of the study was to retrospectively evaluate from 2011 (data of publication of the first American Thyroid Association (ATA) guidelines for thyroid dysfunction in pregnancy) to now medical record of the a secondary level endocrine unit to verify the adherence to guidelines in the management of thyroid function in pregnant women with HT.

The investigators search

1. the adherence to clinical and biochemical endocrine evaluations before conception
2. the use (correct/un-correct) of L-T4 intervention and its monitoring
3. the difference in thyroid function control between women with a fix increment of- L-T4 posology (25 mcg/week more for each 2 kg increment in body weight) after the initial L-T4 adjustment or prescription
4. the clinical and biochemical endocrine evaluation 1-2 months after delivery
5. the outcome of pregnancy
6. the e-mail up-to-date survey on current of off-springs health

Eligibility Criteria:
Inclusion Criteria:

Adult HT pregnant women and adult pregnant women with nodular goiter with or whiteout previous known hypothyroidism.

Exclusion Criteria:

1. significant pre-pregnancy comorbidity including renal failure, severe liver disease, organ transplant, cardiac failure, psychiatric conditions requiring in-patient admission, history of eating disorder.
2. unable to have e-mail address
3. unavailable written consent
4. unable understand Italian language
Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

This study will assess the safety and tolerability of pancrelipase delayed release capsules in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed Cystic Fibrosis (CF) diagnosis by two positive chloride sweat tests or gene analysis
* Current or historical human fecal elastase \< 50µg/gstool
* Weight greater than 3.75 kg
* Age 1 month to 6 years
* Currently receiving treatment with a commercially available pancreatic enzyme product on a stable dose for more than 3 months
* Clinically stable condition without evidence of acute respiratory disease or any other acute condition

Exclusion Criteria:

* Ileus or acute abdomen
* History of fibrosing colonopathy, Celiac disease, gastrectomy, Crohn´s disease and small bowel surgery other than minor resection due to meconium ileus without resulting in malabsorption syndrome
* History of distal ileal obstruction syndrome within 6 months of enrollment
* Use of an immunosuppressive drug
* Any type of malignancy involving the digestive tract in the last 5 years
* Known infection with HIV
Ultrasound-Assisted Paravertebral Block v. Traditional Paravertebral Block For Pain Control

The overall purpose of this research study is to compare the effectiveness of ultrasound assisted paravertebral block placement versus traditional "blind" technique for postoperative analgesia following thoracotomy or visually assisted thoracoscopic surgery.

The purpose of this project is to determine if there is a difference between paravertebral block performed with ultrasound assistance and paravertebral block performed with traditional technique in terms of twenty - four hour hydromorphone (dilaudid) consumption and visual analogue pain scores at rest or with deep breathing at twenty - four hours. This study will determine if ultrasound technique used for placement of paravertebral catheter facilitates safety of paravertebral catheterization and improves therapeutic effect of paravertebral blockade for pain control after thoracotomy. The investigators will also examine if ultrasound assisted paravertebral blockade improves pulmonary status in post-thoracotomy patient.

Eligibility Criteria:
Inclusion Criteria:

* 1. American Society of Anesthesiologists (ASA) I-III subjects
* 2. Ages 18-75 years
* 3. BMI \< 40
* 4. Scheduled for elective thoracic surgery at University of Pittsburgh Medical Center (UPMC) Passavant and Shadyside Hospitals in Pittsburgh, Pennsylvania
* 5. Patients willing and able to provide informed consent

Exclusion Criteria:

* 1) Age younger than 18 years or older than 75 years
* (2) Any contraindication to the placement of unilateral thoracic paravertebral catheter, including local infection, hypocoagulable state.
* (3) American Society of Anesthesiologists physical status IV or greater
* (4) chronic painful conditions
* (5) preoperative opioid use
* (6) coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively
* (7) allergy to lidocaine, ropivacaine or bupivacaine
* (8) personal or family history of malignant hyperthermia
* (9) serum creatinine greater than 1.4 g/dl
* (10) pregnancy or lactating.The pregnancy status will be determined by history and prior pregnancy testing when appropriate
* (11) having an altered mental status (not oriented to place, person, or time) or emergency surgery
* (12) comorbid conditions such as sepsis, unstable angina, congestive heart failure, moderate to severe valvular heart disease, severe chronic obstructive pulmonary disease (COPD)
* (13) patient's inability to provide adequate informed consent
* (14) patient refusal to nerve blocks and/or participation in the study
* (15) respiratory support via ventilator post
* (16) non English speaking
* (17) allergy to contrast of iodine
* (18) emergency surgery or any other non-elective procedure
* (19) unstable vertebral and transverse process fractures
Validation of a Diagnostic Method for Quantification of Sleep Bruxism

This study aims to validate a new diagnostic method for quantification and monitoring of sleep bruxism.

Sleep bruxism has characteristically been defined by the American Academy of Sleep Medicine as 'an oral activity characterized by grinding or clenching of the teeth during sleep, usually associated with sleep arousals'. For sleep bruxism diagnosis, to date the polysomnographic recordings represent the highest standard for sleep bruxism diagnosis, but they are concomitantly associated with disadvantages which include technical complexity, limited availability, and the fact that they are time-consuming and cost-intensive. Recently, a prototype of a diagnostic plate has been developed which allows a fully-automatic, computer-based quantification of abrasion thereupon for the assessment of sleep bruxism activity. The results of the pilot study were promising, and therefore, the aim of the present study is to refine and validate this new diagnostic method for quantification and monitoring of sleep bruxism.

Eligibility Criteria:
Inclusion Criteria:

* Patient has signed and understood the approved informed consent form and is able to meet the proposed study proceedings
* for the sleep bruxism Group: subjects have to fulfill the clinical criteria of the American Academy of Sleep Medicine (sleeping partner's Report of grinding sounds during sleep within the last 6 months, plus at least one of the following symptoms: abnormal attrition of the teeth or shiny spots on dental restorations, hypertrophy of the masseteric muscle upon palpation, and/or self-report of muscle fatigue on awakening. In addition to the clinical criteria for sleep bruxism diagnosis, the following polysomnographic criteria have to be present: bruxism episodes/hr \>4, bruxism burst/hr \>25, at least one episode of grinding per sleep period

Subjects that do not meet any of the clinical or polysomnographic criteria for sleep bruxism were included into the non-sleep bruxism group.

Exclusion Criteria:

* current participation in another interventional Investigation
* cardiac Pacemaker
* central nervous system and peripheral nervous system disorders
* use of sedating medications and/or psychopharmacologically effective drugs
* suspected severe psychological disorder (for example schizophrenia)
* a lack of German language
* drug and/or alcohol abuse
* pregnancy or breast-feeding

Participants of the sleep bruxism group that do not meet any of the clinical or polysomnographic criteria for sleep bruxism were excluded from the sleep bruxism group.

Participants of the non-sleep bruxism group that fulfill the clinical and/or polysomnographic criteria for sleep bruxism were excluded from the non-sleep bruxism group.

Further dental exclusion criteria are:

* prostheses or extensive prosthetic restorations
* dental functional treatment during the last 6 months
* gross malocclusion
* too many missing teeth that omit fabricating a diagnostic plate
* fixed brace
* temporomandibular dysfunction requiring treatment
Gemcitabine in NK/T Cell Lymphoma

We retrospectively review patients with refractory or relapsed ENKL who received a gemcitabine-containing regimen


Eligibility Criteria:
Inclusion Criteria:

* NK/T cell lymphoma
* relapse or refractory disease
* gemcitabine containing treatment

Exclusion Criteria: