cyrilzakka/clinical-trials huggingface dataset:
Methylene Blue Spray for Identification of Recurrent Laryngeal Nerve and Parathyroid Gland

Thyroidectomy is the procedure by which surgeons treat various thyroid diseases and is considered the commonest endocrinal surgery. Yet, it carries a risk for intraoperative complications. The most distressing complications are recurrent laryngeal nerve and parathyroid injuries. Methylene blue spray is a technique than can be used for easy identification of both recurrent laryngeal nerve and parathyroid glands so we can avoid their injuries.

Thyroid disorders constitute the second most common endocrine disease following diabetes mellitus. Thyroid surgery is one of the most frequently operated Head and Neck surgeries. Post-thyroidectomy complications are not uncommon. Parathyroids and Recurrent Laryngeal Nerve (RLN) are two of the complications of thyroidectomy that cause significant postoperative morbidity Due to the advances in thyroids surgeries, the occurrence of postoperative complications has been decreased, but when occurred, they cause lifelong handicap. The most important complications encountered are injury to the RLN and parathyroids. Meticulous dissection is a key factor in minimizing the occurrence of complications During thyroidectomy, careful dissection can protect the parathyroid glands and RLN. Various methods were used including capsular dissection, attention to protection of the arterial supply to parathyroids, avoiding unnecessary manipulation in the area of RLN Methylene blue spraying is a new technique that allows identification of both parathyroid glands and recurrent laryngeal nerves

Eligibility Criteria:
Inclusion Criteria:

* Age of 16 years and older.
* Both sexes.
* Patients who are candidate for thyroid surgery and euthyroid.

Exclusion Criteria:

* - Patients with hyper- or hypo-thyroid status.
* Patients who were unfit for surgery.
* Patients with unilateral or bilateral vocal cord palsy on preoperative indirect laryngoscopy
* Patients with thyroid malignancy by preoperative FNAC.
* Patients with hypersensitivity to methylene blue were excluded.
Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation

A randomized double---blinded comparison of same---day mifepristone and misoprostol with misoprostol only for cervical preparation in second---trimester surgical abortion in 100 women at 14 0/7---19 6/7 weeks gestation.

Women desiring abortion at gestational ages between 14 weeks 0 days and 19 weeks 6 days were randomized to 200-mg mifepristone or identical placebo with 400-mcg misoprostol vaginally 4-6 hours prior to D\&E. Primary outcome was cervical dilation assessed by the largest Hegar dilator accepted without resistance. Secondary outcomes included total procedure time, and patient and provider perceptions. The study was powered to detect a 2-mm difference in cervical dilatation with 48 participants in each arm.

Eligibility Criteria:
Inclusion Criteria:

* healthy women
* eligible for non---urgent D\&E
* 14 0/7 weeks to 19 6/7 weeks gestation, confirmed by sonogram

Exclusion Criteria:

* emergent need for D\&E
* fetal demise
* intolerance
* allergy or contraindication to mifepristone or misoprostol
Single and Dual Task Balance Exercises in Substance Use Disorders

Changes in the brain reward pathway and brain tissue in alcohol and substance addiction cause balance disorders, cognitive problems, depression, and substance cravings in individuals. The aim of this study is to examine the effects of balance exercises and dual task balance exercises in individuals with alcohol or substance addiction who are receiving treatment.

This randomized controlled trial was conduces in Ankara Training and Research Hospital, Alcohol and Substance Addiction Treatment Center, Turkey. Individuals who used substances for more than 1 year, between the ages of 18-50 and with a Mini-Mental State Examination score of 24 and above were included in the study. Individuals with orthopedic, neurological or systemic disease, problem with vision and hearing, a neurodevelopmental or neurocognitive disorder and active infection were excluded from the study. In addition, individuals under the effect of substances that negatively affect their cognitive functions were not included in the study. Before starting the study, the Mini-Mental State Examination was used to determine that the individuals were at a cognitive level to complete the tests to be applied. The demographic characteristics of the individuals were saved. The Stroop Test-Çapa Form was used to evaluate executive functions. Y Balance Test, Time Up Go Test and 10 meter walk test were used to evaluate balance. Patients were randomly divided into 2 groups. The first group received only balance exercise and the second group received balance exercise with motor and cognitive dual tasks.

Eligibility Criteria:
Inclusion Criteria:

* Being literate,
* Having a diagnosis of alcohol and substance use disorder according to The Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5),
* More than 1 year of substance abuse,
* Receiving treatment within the scope of the fight against addiction,
* Not participating in a regular exercise program in the last six months.

Exclusion Criteria:

* Scoring 23 and below on the Mini Mental Test,
* Having a neurodevelopmental or neurocognitive disorder,
* Being under the influence of drugs or alcohol in a way that negatively affects the person's -cognitive functions,
* Having a psychiatric disorder that requires treatment other than opiate and tobacco use disorder according to DSM-5 diagnostic criteria,
* Cognitive impairment due to mental retardation, drug/substance abuse or other medical condition that may cause difficulty in understanding the study instructions,
* Being diagnosed with any orthopedic, neurological and systemic disease,
* Having an active infection,
* Having problems with vision and hearing.
Evaluation of the Prevalence of Oral HPV Infection in Patients Who Are Positive to the PAP-test

The present cross-sectional study aims to assess the prevalence and type distribution of oral HPV infection in PAP-test-positive women aged ≥18 years. The means used in the present study will be the use of anamnestic questionnaires and exfoliative cytology tests at predetermined oral mucosal sites (lingual belly and dorsum, palate, and buccal mucosa).

The present cross-sectional study aims to evaluate the prevalence and distribution of the type of oral HPV infection in PAP-test positive women.

aged ≥18 years. Sociodemographic and anamnestic data will be collected by questionnaire administration. Data collected will be age, marital status, number of sexual partners, HPV vaccination, oral sex, contraceptive use, systemic diseases, smoking, alcohol consumption, etc.. Next, patients will undergo oral cavity inspection and exfoliative cytology testing at predetermined oral mucosal sites (lingual belly and dorsum, palate, and buccal mucosa).

Sample taken sent for cytological analysis to determine the presence of viral DNAand possible typing.

Eligibility Criteria:
Inclusion Criteria:

* Female patients with positive PAP test;
* Age ≥ 18 years

Exclusion Criteria:

* Female patients with negative PAP test
* Uncooperative patients
* Patients with mental deficits
* Age\<18 years
Upper Limb Activity in Human SCI Rehabilitation

Functional recovery following SCI in adults is limited. Improvements in the quality of life of affected persons are associated with the recovery of functions that allow independent living, for example use of the arms and hands. Rehabilitative training has been shown to aid upper limb recovery. However, there are likely vast differences in the amount of time individuals spend actively training (during rehabilitation sessions in the clinic) and what they do in their non-training time (during daily life). The activity, or lack of, during the non-training period could interfere (positively or negatively), with the specific training in the rehabilitation session. However, there is little information available about this.

Inertial measurement units are increasingly being used in human movement and rehabilitation research. The use of such technology is a promising approach to rapidly and discreetly collect objective movement information. The investigators plan to introduce a novel, long-term, activity sensor into clinical SCI rehabilitation. The investigators use this sensor to precisely measure movement of the upper limb over extended periods of time. Upper limb activity recordings from these sensors allow us to detail the amount and duration of activity during specific periods of upper limb rehabilitation and recovery.

The investigators aim is to measure upper limb activity. The investigators aim to track changes in the activity of the upper limb during recovery and rehabilitation in patients with cervical SCI as well as collect reference values of upper limb activity in chronic sufferers. The recordings from this activity sensor will provide a more detailed understanding of how everyday upper limb activity contributes to functional recovery.


Eligibility Criteria:
Inclusion Criteria:

* Tetraplegic and paraplegic subjects.
* Males and females aged 18 or older.
* Acute (defined here as \<90 days after admission of SCI) for the longitudinal follow-up study, as well as chronic (defined here as \>90 days after admission of SCI) for the cross-sectional study, all levels of injury, complete and incomplete, traumatic and non-traumatic injuries.
* Good enough cognitive ability to be able to follow simple verbal instructions.
* Signed informed consent before study onset.

Exclusion Criteria:

* A neurological disease other than SCI, which is expected to affect the upper limb function, i.e. plexus paresis.
* An orthopaedic or rheumatologic disease, e.g. osteoarthritis, which is expected to affect the upper limb function.
* Pre-morbid on-going major depression or psychosis.
Peripheral Metabolic Effects of Somatostatin

The aim of this study is to investigate peripheral effects of Somatostatin on glucose metabolism and growth hormone (GH) signalling in healthy men. Eight subjects will be enrolled. The hypothesis is that Somatostatin infusion reverses insulin resistance caused by GH.


Eligibility Criteria:
Inclusion Criteria:

* BMI \< 27 kg/m2
* Written informed consent
* Healthy

Exclusion Criteria:

* Any disease
* Any use of medications
* Present or previous malignancy
* Alcohol dependency
* Allergy to trial medication
Long-Term Follow-up Study of ADVM-043

ADVM-043-03 is a long-term follow-up (LTFU) study of subjects who participated in the ADVM-043-01 (NCT02168686) multi-center gene therapy clinical study (ADVANCE) that evaluated ADVM-043 for the treatment of Alpha-1 Antitrypsin (A1AT) deficiency.

ADVM-043-03 was a multi-center, observational study without administration of the ADVM-043 investigational product. Subjects who participated in the ADVANCE study (ADVM-043-01; NCT02168686) were enrolled into this LTFU study for continued safety monitoring for a 2-year period.

Eligibility Criteria:
Key Inclusion Criteria:

* The subject has A1AT deficiency and has previously received ADVM-043 gene therapy

Key Exclusion Criteria:

* The subject is unwilling or unable to participate in all required study evaluations in the long-term follow-up protocol
* The subject is participating in another investigational treatment protocol
* The subject is unable to understand the purpose and risks of the study or cannot provide a signed and dated informed consent form (ICF)
Clinical Utility of Electrical Impedance Spectroscopy

The purpose of this clinical study is to evaluate the clinical utility of the Nevisense in normal clinical practice, i.e. the potential effect of implementing Nevisense in clinical decision making (Human vs Human \& Machine) based on Nevisense measurement at time of biopsy decision.

This is a multi-center, prospective, blinded clinical study designed to evaluate clinical utility of Nevisense in normal clinical practice, i.e. the potential effect of implementing Nevisense in clinical decision making (Human vs Human \& Machine) based on Nevisense measurement after biopsy decision. The study enrollment will continue until minimum of 180 subjects are enrolled in the study. Up to 3 US university/hospital investigational sites will participate in this study. Biopsying clinician or the investigators from the clinical practices of physicians participating in the study will perform the patient and lesion assessment for biopsy as standard of care at the clinic.

Study subjects will be recruited from the clinical practices of physicians participating as investigators in this study. Biopsying clinicians provide their assessment to whether s/he would have sent the lesion(s) for biopsy had s/he known the EIS information beforehand . Thereafter an evaluation of the suspicious lesion with the Nevisense will be performed followed by a biopsy of the lesion. The biopsied lesion will be subjected to histological analysis.

Eligibility Criteria:
Inclusion Criteria:

* The lesion(s) meet criteria for Nevisense evaluation.
* Lesions that present with unclear clinical presentation to allow for clinical diagnosis of benign or minimally dysplastic nevus (nevi) -Thus, necessitating a biopsy.
* Lesions within Nevisense indication for use: Nevisense is indicated for use on cutaneous lesions with one or more clinical or historical characteristics of melanoma, when a dermatologist chooses to obtain additional information when considering biopsy. Nevisense should not be used on clinically obvious melanoma. The Nevisense result is one element of the overall clinical assessment. The output of Nevisense should be used in combination with clinical and historical signs of melanoma to obtain additional information prior to a decision to biopsy. Nevisense is indicated only for use on:

  * primary skin lesions with a diameter between 2 mm and 20 mm;
  * lesions that are accessible by the Nevisense probe;
  * lesions where the skin is intact (i.e. non-ulcerated or non-bleeding lesions);
  * lesions that do not contain a scar or fibrosis consistent with previous trauma;
  * lesions not located in areas of psoriasis, eczema, acute sunburn or similar skin conditions;
  * lesions not in hair-covered areas;
  * lesions which do not contain foreign matter;
  * lesions not on special anatomic sites (i.e. not for use on acral skin, genitalia, eyes, mucosal areas).

Exclusion Criteria:

* Subjects who fail to provide informed consent
* Study subjects with underlying medical disease which may alter ability to diagnose clinically or inhibit Nevisense from collecting data
The Use of Natural Latex Biomembrane in Ocular Surface Reconstruction

The main problem of ocular surface reconstruction is the lack of viable conjunctival tissue. The use of a biocompatible latex biomembrane in ocular surface healing, like post pterygium surgery, could be an alternative therapeutic resource to this process.

The latex biomembrane is considered biocompatible and believed to promote neoformation of biological tissues. It also induces vascular neoformation and promotes extra cellular provisional matrix formation, fundamental steps for any kind of wound healing. In humans, it was successfully used in chronic cutaneous ulcer and otologic surgeries. In rabbits' eyes, the latex biomembrane was efficient in ocular surface reconstruction with adequate conjunctiva functional recovery, compared to bare sclera. To study the latex biomembrane action in human ocular surface, it was compared to conjunctival autograft in humans eyes. Considering the deficiency of adequate sized groups and the pterygium recurrences criteria differences, this study proposes the fibrovascular tissue growing measure like an auxiliary method of pos-operative evaluation. The biomembrane of natural latex seems to be efficient in ocular surface reconstruction and must be employed in future studies of other ocular pathologies. This material revealed to be a new source of therapeutic resort to external eye diseases and conjunctival replace in surgeries living bare sclera.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic pterygium

Exclusion Criteria:

* any other ocular surface pathology, glaucoma, retinal disease, pregnancy, auto immune disease, severe systemic disease
Health Status of the Patients Followed for a Disease of Cushing in the Region Large-West of 1990 to 2015

Cushing's disease is a rare disease that can reduce patients' expectations or quality of life, and for which predictive factors for cardiovascular mortality and recurrence are not well defined.

The primary objective is to determine the rates of remission and recurrence of patients with Cushing's disease diagnosed between 1990 and 2015 in the French region of the West (Angers, Brest, Nantes, Rennes, Poitiers , Tours) focusing on remission particularly at two periods : that after the first pituitary surgery and that on the day of the last news.

The secondary objective is to study the possible prediction of clinical and biological data perioperative of remission and recurrence during follow-up.

Investigators are interested in the prevalence of complications of the pathology (cardiovascular, metabolic, neuropsychological, infectious, rheumatological, etc.) within this cohort, the mortality rate, the rate of remission and recurrence and the quality of life history using the history of patient illness and a questionnaire.

All patients over the age of 18 years at the time of inclusion, formerly or currently being monitored for Cushing's disease diagnosed between January 1, 1990 and December 31, 2015, in one of the six university centers in the West part of France can be included.

Eligibility Criteria:
Inclusion Criteria:

* patients over the age of 18 at inclusion,
* formerly or currently being followed for Cushing's disease diagnosed between 1 January 1990 and 31 December 2015 in one of the six university centers in the French West.

Exclusion Criteria:

* Minor patients,
* patients with a pathologic analysis in favor of a mixed secretion adenoma (positive immunohistochemical analysis for ACTH and another hormone of the anterior pituitary).
* patients who have undergone a pathologic diagnosis of "adenoma to ACTH" without clinical-biological Cushing syndrome, ie silent adenoma
Near Infrared Spectroscopy (St02)

The overall hypotheses of this project is that Near Infrared Spectroscopy (NIRS) can be used to identify morbidity, mortality, and resource utilization in patients with sepsis and septic shock.

Near-infrared spectroscopy (NIRS) noninvasively measures peripheral tissue oxygen saturation (StO2), offering promise as a guide in the early treatment of severe sepsis; however, the role and utility of this technology is still evolving.

There are three main NIRS measurements reported in the literature: continuous StO2 measurement (StO2 initial), StO2 occlusion slope (StO2 downslope) in response to VOT testing and StO2 recovery slope (StO2 upslope) in response to vasoocclusive testing. The purpose of this study is to assesses the association of each of these parameters with severity of illness, organ dysfunction and death.

This study will utilize the Hutchinson InSpectra StO2 tissue oxygenation monitor, which is FDA approved for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle, or when there is a suspicion of compromised circulation.

Eligibility Criteria:
There will be three cohorts enrolled in this study: (1) Septic Shock, (2) Sepsis and (3) Controls.

Inclusion Criteria:

Listed on the Cohorts description.

Exclusion Criteria:

All patient cohorts will share common set of exclusion criteria:

* Age \< 18 years
* Pregnancy
* Established "Do Not Resuscitate" orders prior to enrollment
* Primary diagnosis of:

  * Acute traumatic or burn injury
  * Acute cerebrovascular event
  * Acute coronary syndrome
  * Acute pulmonary edema
  * Cardiac dysrhythmia
  * Acute and active gastrointestinal bleeding
  * Acute drug overdose
  * Requirement for immediate surgery
  * Inability to obtain written informed consent
Additional Effect of Wound Infiltration After Cesarean Section With Optimal Standard Analgesia

The purpose of this study is to determine wether wound infiltration brings additional analgesia effect after cesarean section with optimal standard postoperative analgesia

Continuous wound infiltration with local anaesthetic has been shown as a safe and opioid-sparing analgesic method after caesarean section with minimal standard analgesia. We aim to evaluate if this benefit remains when an optimal analgesia is used.

Primary outcome is morphine consumption. Secondary outcomes is pain scores, maternal recovery including breastfeeding, side effects of morphine, nurse workload and maternal satisfaction.

Patients scheduled for caesarean delivery will be eligible for the study.

Patients with emergency caesarean delivery, contraindication to analgesic drugs, hemostasis disorder, ongoing infection, diabetes treated with insulin or chronic opioid use will be excluded from the study.

One group will receive standard analgesia including celecoxib and intravenous morphine for 24 hours with Patient Controlled Analgesia pump. The other group will receive the same standard analgesia with additional levobupivacaine initial bolus followed by a continuous subfascial infiltration of 1.25 mg/ml at 5 ml/h for 48 hours through a multiperforated catheter connected to an elastomeric pump.

Total morphine consumption, pain and any associated complications will be recorded for 72 hours. Women wil be asked to fulfill a questionnaire on the second day after cesarean section, assessing recovery, satisfaction and breastfeeding comfort.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled cesarean section

Exclusion Criteria:

* Emergency cesarean section
* Contraindication to opioids, paracetamol, or local anaesthetic
* Ongoing infection
* Coagulation disorders
* Diabetes treated with insulin
* Chronic opioid use