cyrilzakka/clinical-trials huggingface dataset:
Impact of Dissection Area on the Clinical Outcome of Endoscopic Thyroidectomy

The purpose of this study is to investigate whether reduced subcutaneous dissection area could offer patients more clinical benefits.

To create a working place in the chest wall is an inevitable step of endoscopic thyroidectomy. Large subcutaneous area was considered a drawback of endoscopic thyroidectomy. The purpose of this study is to investigate whether subcutaneous dissection area has influence on clinical outcome of endoscopic thyroidectomy, such as post-operative pain, complication rate and post-operative discomfort.

Eligibility Criteria:
Inclusion Criteria:

* thyroid nodule diagnosed by ultrasound
* willing to undergo endoscopic thyroidectomy

Exclusion Criteria:

* conversion to open surgery
* unwilling to join the research
Investigation of Related Factors in Patients With Non-Specific Neck Pain

It has been shown that there is a complex association between neck pain, temporomandibular joint dysfunctions, and migraines, and that these conditions can be influenced by factors such as depression, physical inactivity, and health-related quality of life. Likewise, it is observed that all the factors within this complex structure can actually act as triggers, initiators, or intensifiers of each other.

In recent years, with a more detailed examination of their physiological connections, a reciprocal triangular relationship has been demonstrated between temporomandibular joint (TMJ) dysfunctions, headaches-especially migraines-and neck pain.

A detailed correlation of risk factors affecting neck pain-primarily temporomandibular joint involvement and headaches-in patients with neck pain will help identify underlying secondary effects and facilitate the inclusion of patient-centered, specific exercises in rehabilitation programs for these patients.

Studies in the literature indicate that the relationship between neck pain, temporomandibular joint dysfunctions, and migraines has not been evaluated collectively, and the impact of factors such as depression, physical inactivity, and health-related quality of life on these conditions has not been thoroughly assessed. Therefore, this study aims to comprehensively investigate the effects of temporomandibular joint dysfunctions, migraines, and other associated factors in individuals with non-specific neck pain.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18 and 70
* Having non-specific neck pain
* Experiencing migraine-related headaches

Exclusion Criteria:

* Having a diagnosis of cervical trauma, surgery, or disc herniation
* Having a diagnosis of abnormal range of motion in the TMJ or cervical spine, scoliosis, or kyphosis
* Having neurological impairments
* Having systemic diseases
* Having dental or oral pathological lesions, oral infections, facial paralysis, or neuropathic facial pain
Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Same Vaccine

The proposed study V72P6E1 is an Extension Study of V72P6 (NCT00381615). The objectives of this extension study will be to explore antibody persistence at approximately 40 months of age and to evaluate the safety, tolerability and immunogenicity of booster doses of rMenB±OMV NZ administered to subjects at approximately 40 months of age. Antibody persistence will be subsequently measured at 18-20 months after these booster doses when the subjects are 60 months of age. Two groups of naïve subjects, aged approximately 40 and 60 months, will be recruited in the study to serve as a baseline comparator for assessing antibody persistence at these ages. These subjects will receive a two-dose catch-up regimen with rMenB+OMV NZ. Subjects who are enrolled at 40 months of age are offered DTaP/IPV and MMR vaccinations, if they have not already received these vaccines prior to enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Healthy 40 to 44-months-old children, who participated and completed the study V72P6 (NCT00381615; follow-on subjects)
* Healthy 40 to 44-months or 60 to 62-months-old children (naïve subjects)

Exclusion Criteria:

* Previous ascertained or suspected disease caused by N. meningitidis
* History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component
* Any serious chronic or progressive disease
* Known or suspected impairment/alteration of the immune system
* Receipt of, or intent to immunize with another vaccine, within 30 days prior and after vaccination with the investigational vaccines (within 14 days for licensed flu vaccines)
Investigation of a Digital Healthy Habits Program for Individuals With Breast Cancer

This mixed methods study will involve obtaining user feedback on the first 4 weeks of the Healthy Habits for Cancer (HCC) Program. Short pre and post surveys and in-depth qualitative interviews will be conducted exploring their views on the app (features they liked and didn't like), the extent to which they believe the app would have to be further adapted, how they would feel about such an app being embedded in their cancer care and when in their care pathway they would like to be offered it.

This mixed methods study will involve obtaining user feedback on the first 4 weeks of the Healthy Habits for Cancer (HCC) Program. Participants will be recruited and asked to try the HCC app for 4 weeks. Short pre and post surveys and in-depth qualitative interviews will be conducted exploring their views on the app, the extent to which they believe the app would have to be further adapted, how they would feel about such an app being embedded in their cancer care and when in their care pathway they would like to be offered it.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and provide informed consent
* 18 years and older
* Female
* \> 6 months postpartum
* Not currently pregnant or planning to become pregnant in the next 5 months
* Diagnosed with stage I-IV breast cancer \< 5 years ago:
* Completed active breast cancer treatment (e.g., chemotherapy, radiation, surgery) 1 month to 5 years ago, with the exception of hormonal/endocrine therapy
* Currently prescribed hormone therapy (e.g. Tamoxifen) as a breast cancer treatment
* Not diagnosed with an eating disorder
* Healthy weight, overweight, or obesity (BMI ≥ 18.5)
* Willingness to use the program over the course of the 4 weeks in order to enable them to provide feedback on its features
* Own a smartphone with iOS operating system (i.e., Apple iPhone)

Exclusion Criteria:

* Inability or unwillingness of a participant to give written informed consent
* Underweight (BMI \< 18.5)
* Currently pregnant or \<6 months postpartum
* Presence of a diagnosed physical or mental health condition or abnormality that impacts the ability to participate in a program that involves asking participants to monitor diet, physical activity, or weight (e.g., eating disorder, bipolar disorder). If there is any doubt at initial screening the investigator will recommend that the patient receives sign off from their clinical team.
* Currently undergoing IV chemotherapy or radiation
* Plans for surgery in the next 6 weeks
* Currently diagnosed or being treated for a second primary cancer (i.e. cancer of another organ, not due to breast cancer metastasis), with the exception of non-melanoma skin cancers (e.g. basal cell carcinoma)
Proof of Concept Study on Pitolisant Effect on Autism Spectrum Disorders in Children and Adolescents

Proof of concept, multicenter, randomized, double-blind, placebo-controlled, parallel-group, study to investigate the effect, safety, tolerability and pharmacokinetics of pitolisant in male children and adolescents with Autism Spectrum Disorders.

First clinical study to assess the effect of BF2.649 in male children and adolescent with a diagnosis of Autism spectrum disorders according to DSM-5 criteria and confirmed by the Autism Diagnostic Observation Schedule (ADOS-2) or Autism Diagnostic Interview-Revised (ADI-R) over a 12-weeks period.

Eligibility Criteria:
Inclusion Criteria:

* Participants and their parent(s)/legal guardian(s) are willing and able to give informed assent and consent for participation in the study.
* Male children and adolescents aged from 6 to 17 inclusive for the duration of study participation.
* Diagnosis of autism spectrum disorders (ASD) as per the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria confirmed by the Autism Diagnostic Observation Schedule (ADOS-2) or the Autism Diagnostic Interview-Revised (ADI-R).
* Intelligence Quotient (IQ) ≥ 70 using Wechsler Intelligence Scale.
* Social Responsiveness Scale Second Edition (SRS-2) total T-score ≥ 66 at screening and baseline.

Exclusion Criteria:

* Previous genetic diagnosis of ASD-known "syndromic" ASD (e.g., Fragile X syndrome, Angelman syndrome, Prader-Willi, Rett's syndrome, tuberous sclerosis, Dup15q syndrome).
* History of suicidal behavior or suicidal ideation in the past 12 months, or a positive answer to questions 4 or 5 on the Columbia-Suicide-Severity Rating Scale (C-SSRS) at screening and/or baseline, and/or is a significant risk for suicidal behavior per investigator judgement.
* History or current diagnosis of epilepsy or any seizure occurring after the age of 5.
* Clinically significant deviation from normal on 12-lead ECG that results in an active medical problem, per investigator judgement or, with a corrected QT interval by Fridericia (QTcF) \> 450ms at screening.
* Severe hepatic impairment (Child Pugh C) or with any other hepatic significant abnormality in the physical examination or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) ≥ 2x Upper Limit of Normal (ULN) for age at laboratory results.
The Effects of Estradiol and Progesterone on Arginine Vasopressin Regulation and Serum Sodium Concentration

Women are at greater risk for exercise-induced hyponatremia (low blood sodium concentration) and this risk has been attributed to their lower body weight and size, excess water ingestion and longer racing times relative to men. While these factors contribute to the greater incidence of hyponatremia in women, it is likely that their greater levels of estradiol in plasma and/or tissue also play a role in increasing the risk of hyponatremia in women. More importantly, estradiol may also leave women more susceptible to the extreme consequences of hyponatremia (i.e. brain damage, death). Hyponatremia is generally attributed to inappropriately elevated levels of the hormone arginine vasopressin (AVP). AVP is the most important hormone controlling water retention in the kidney. Earlier studies in our laboratory have demonstrated that estradiol lowers the threshold for thirst sensation and AVP release during exercise. The purpose of these studies is to test the hypotheses that in women with a history of hyponatremia, estradiol lowers the thresholds for thirst and AVP release, leading to greater fluid retention, lower blood sodium concentration during endurance exercise in the heat. However, we further hypothesize that progesterone administration along with estradiol administration will attenuate the effect of estradiol on the regulation of thirst and AVP, normalize fluid retention, and serum sodium concentration during endurance exercise in the heat. In women without a history of hyponatremia, we expect that estradiol administration will lower the thresholds for thirst and AVP release, but will not increase fluid retention or reduce blood sodium concentration during endurance exercise in the heat. We hypothesize that progesterone administration along with estradiol administration will attenuate the effect of estradiol on thirst and AVP, but have no effect on fluid retention or serum sodium concentration during endurance exercise in the heat. To test these hypotheses, women will perform endurance exercise in the heat under three hormonal conditions: 1) during Gonadotropin-releasing hormone (GnRH) antagonist alone--which will suppress estradiol and progesterone; 2) during GnRH antagonist+estradiol; and 3) during GnRH antagonist+estradiol+ progesterone. During exercise, fluid will be replaced with either water or a carbohydrate-electrolyte beverage (random assignment).


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers (18-35 yrs) with and without previous exercise induced hyponatremia

Exclusion Criteria:

* conditions that would preclude safe exercise or safe use of hormones
Quality of Life Assessment of Cryotherapy in Esophageal or Gastroesophageal Cancer

Cryoablation combined with chemotherapy on the quality of life of patients with non resectable esophageal or gastroesophageal cancer.

This is a single arm prospective study to determine the effect of cryoablation combined with chemotherapy on the quality of life of patients with non resectable esophageal or gastroesophageal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Has esophageal or gastroesophageal cancer and will be receiving chemotherapy
* Dysphagia score of 1, 2, 3 or 4.
* Age ≥18 years old
* American Society of Anesthesiologists (ASA) Physical Status Classification ≤ 4
* Deemed not a candidate for esophageal cancer surgical resection
* Female subjects must be either post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control (i.e., total abstinence, birth control pills, an intrauterine device (IUD), diaphragm, progesterone injections or implants, or condoms plus a spermicide) for the duration of the study

Exclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status greater than 2
* Patient who received radiation treatment in the prior 8 weeks
* Known brain metastases causing cranial nerve deficits which can cause dysphagia
* Inability to undergo an esophagogastroduodenoscopy (EGD)
* Pregnant or nursing
* Surgery or anatomy where capacity of stomach is reduced making cryotherapy contraindicated
* Patients with tracheoesophageal fistula
Smoking Cessation and a Teachable Moment in Patients With Acute Fractures

Patients who smoke and suffer from fractures are worse off than those who do not smoke. Orthopaedic patients represent a group that can benefit from physician contributions to smoking cessation, and a special opportunity to cue this can begin with the orthopaedic surgeon in the acute setting. However, the best way to appropriately counsel these patients and assess the impact as a teachable moment remains undetermined.

If the patient self-identifies as a smoker, the investigators will consent and randomize to receive the intervention or not. Either way, all will receive a baseline attitude survey. The patient will be given a series of questions that target the areas of interest noted in the model. At some point in their hospitalization, preferably at least one day later and no greater than one week later, the patients will be given the teaching intervention (or not), and receive another attitude survey. After discharge, the patients will be expected in orthopaedic follow up clinic. At that time they will receive another attitude survey. If unable to deliver at that time, they will be contacted by phone or sought at their second clinic follow up.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 or over, who are not under the jurisdiction of the department of corrections
* Individuals receiving care from University of Pennsylvania Health System clinicians for orthopaedic injuries
* Individuals who self-identify as smokers

Exclusion Criteria:

* Under age 18
* Under the jurisdiction of the department of corrections
* Nonsmokers
* People not currently receiving fracture care
The VERISMART Trial

Catheter ablation is now routinely used in the management of heart rhythm disorders. One of the problems with the approach is that it has not been possible to determine whether the ablation catheter is in direct contact with the heart tissue or not. This is important because too much contact has safety implications and too little means that the therapy will be ineffective. Recently two different technologies have been developed to determine contact. Currently it is not know if one is superior to the other, and the objective of this trial is to determine whether there is a difference when treating a rhythm called atrial flutter.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Documented paroxysmal or persistent atrial flutter

Exclusion Criteria:

* Inability or unwillingness to receive oral anticoagulation
* Previous ablation procedure for AFL
* Unwillingness or inability to complete the required follow up arrangements
* Concomitant atrial fibrillation
Impact of Age at Conization on Obstetrical Outcome: A Case-Control Study

The maternity ward attached to the colposcopy clinic was also the obstetrical referral center for the region and carried out approximately 2500 deliveries per year. The aim of the study was to assess whether an age younger than 25 years at conization affected future pregnancy outcome as an independent factor. A retrospective study of 115 women who underwent both loop electrosurgical excision procedure (LEEP) and subsequent pregnancy follow-up in a referral center was conducted. Two groups were considered: patients younger than 25 years at the time of the loop electrosurgical excision procedure (n = 42) and 25 years or older (n = 73). Analyzed data were occurrence of preterm adverse obstetrical event and, specifically, preterm labor (PL) and preterm rupture of membranes; stratification based on term of occurrence was performed: less than 37 weeks of amenorrhea (WA), less than 34 WA, and less than 26 WA.

The investigators conducted a retrospective observational study between January 2008 and December 2015 in a French colposcopic referral academic hospital. The maternity ward attached to the colposcopy clinic was also the obstetrical referral center for the region and carried out approximately 2500 deliveries per year. The aim of the study was to assess whether an age younger than 25 years at conization affected future pregnancy outcome as an independent factor. A retrospective study of 115 women who underwent both loop electrosurgical excision procedure (LEEP) and subsequent pregnancy follow-up in a referral center was conducted. Two groups were considered: patients younger than 25 years at the time of the loop electrosurgical excision procedure (n = 42) and 25 years or older (n = 73). Analyzed data were occurrence of preterm adverse obstetrical event and, specifically, preterm labor (PL) and preterm rupture of membranes; stratification based on term of occurrence was performed: less than 37 weeks of amenorrhea (WA), less than 34 WA, and less than 26 WA.

Eligibility Criteria:
Inclusion Criteria:

* female pregnant
* underwent loop electrosurgical excision procedure during the studied period
* delivered in their institution

Exclusion Criteria:

* patients having delivered elsewhere after loop electrosurgical excision procedure
* Early miscarriages (\<14 weeks of amenorrhea )
Curcumin and Piperine in Reducing Inflammation for Ureteral Stent-Induced Symptoms in Patients With Cancer

This pilot phase I trial studies the side effects and best dose of curcumin when given together with piperine (piperine extract \[standardized\]) in reducing inflammation for ureteral stent-induced symptoms in patients with cancer. Curcumin is a spice similar to turmeric and works by decreasing the chemical moderators that produce inflammation in the body. Piperine is pepper and works by increasing the amount of curcumin available in the body when taken with curcumin. Giving curcumin together with piperine may reduce inflammation and discomfort from a ureteric stent in older patients with cancer.

PRIMARY OBJECTIVES:

I. To conduct a dose-escalation study with curcumin and piperine to derive a safe, optimal biological dose of this combination in cancer patients.

SECONDARY OBJECTIVES:

I. To describe the grade 2+ toxicities associated with curcumin and piperine. II. To evaluate quality of life associated with this combination by means of the Mayo Modified Urinary Stent Symptom Questionnaire (USSQ).

TERTIARY OBJECTIVES:

I. To characterize the change in urinary prostaglandin E2 concentrations that occur at baseline and then after one week of curcumin + piperine.

OUTLINE: This is a dose-escalation study of curcumin.

Patients receive curcumin orally (PO) twice daily (BID) or thrice daily (TID) and piperine extract (standardized) PO on days 1-7 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 month.

Eligibility Criteria:
Inclusion Criteria:

* Ureteral stent in place at study registration
* Patient reports pain, spasms, or urgency symptoms after stent placement, which are thought to be unrelated to other causes as per the patient or healthcare provider or both (documentation in the medical record is unnecessary)
* Ability to complete English language questionnaires by themselves or with assistance
* After the week-long study treatment, participants must be willing to return to the enrolling institution for a follow-up visit
* Willingness to provide mandatory 24 hour urine collection samples for research purposes
* Able to swallow supplements
* Patient must have either a history of cancer or active cancer
* Registration \>= 7 days after placement of a new stent or \>= 3 days after a stent exchange
* Willingness to refrain from grapefruit juice for 7 days prior to and for 7 days during the study

Exclusion Criteria:

* Receiving warfarin at registration
* Active cholecystitis
* Taking any of the following drugs at the time of study participation: epidermal growth factor receptor inhibitor, topoisomerase 1 inhibitor (camptothecin, irinotecan); buspirone, benzodiazepines, zolpidem, calcium channel blockers (such as felodipine, nifedipine, verapamil); digoxin or quinidine; codeine or fentanyl; phenytoin, propranolol, rifampin, or theophylline
* History of alcohol abuse