cyrilzakka/clinical-trials huggingface dataset:
Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation

We continue to collect information in support of the hypothesis that the histology of the first draining lymph node (sentinel node) accurately predicts the histology of the rest of the axillary lymph nodes.

Using a technique combining Technetium-99 sulfur colloid and Lymphazurin Blue Dye, we have established that the sentinel node predicts the pathology results of the rest of the axillary lymph nodes. This minimally invasive technique, which can be readily performed under local anesthesia, makes the need for full axillary lymph node dissection unnecessary for most patients. If the sentinel node is negative, no further surgery is necessary. If positive, a complete axillary node dissection is performed. In addition, the injections are made while the patient is under anesthesia, reducing the physical and psychological pain that accompanies injections done pre-operatively.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer requiring lymph node evaluation
* Clinically negative lymph nodes in the axilla
* Willing participation following an informed consent process

Exclusion Criteria:

* Patients with clinically positive lymph nodes
* Pregnancy (if a pregnant female should be diagnosed with breast cancer an exception would be considered on a case to case basis)
* Previous axillary lymphadenectomy
The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer

Diarrhea in patients with MTC (Medullary Thyroid Cancer) can be debilitating and, in some cases life threatening. Findings in such patients include volume depletion, renal insufficiency, and electrolyte disorders. Diarrhea can also lead to increased cost of care, reduced quality of life, and treatment delays. Not all patients benefit from conventional anti-diarrheal therapy. CASAD is proven to reduce diarrhea in humans and animals. Clays have water-binding effects, increase the absorptive capacity of the intestinal mucosa, and absorb the excess cytokines which are possible mechanisms of diarrhea in MTC. In this study, we will investigate if starting 1 g CASAD three times a day will ameliorate the severity of diarrhea in patients with MTC. Diarrhea in patients with MTC can be debilitating and, in some cases life threatening. Findings in such patients include volume depletion, renal insufficiency, and electrolyte disorders. We hypothesize that adding CASAD 3 grams/day will reduce the incidence and ameliorate the severity of diarrhea in patients with MTC.


Eligibility Criteria:
Inclusion Criteria:

* Patients with medullary thyroid cancer
* Men and women from all ethnic and racial groups
* Diarrhea ( \>=3 loose bowel movements per day)
* Duration of diarrhea of at least 1 week

Exclusion Criteria:

* Patients with MEN 2b (since these patients may have megacolon)
* Patients taking any clay products
* History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up.
* Patients who cannot comply with medications
* Patients whose current medication schedule would not permit an approximate 2 hour window between administration of CASAD and other scheduled medications.
* Pregnancy or lactation
* Patients receiving systemic chemotherapy (includes tyrosine kinase inhibitors)
Impact of Sarcopenia Using an Easy Psoas Area Measurement

The purpose of this study is to compare the post-operative course in patients suffering from sarcopenia who had colorectal surgery for cancer. Our primary outcome is the comparaison of the length of hospital stay in sarcopenic and non sarcopenic patients.

Sarcopenia is the loss of muscle mass that occurs usually with aging, but it may have multiple contributing factors, especially related to chronic diseases such as colorectal cancer.

When present, sarcopenia is predictive of poor post-operative course. The identification of sarcopenia needs either the identification of low muscle strength, low muscle quantity/quality, or finally a low physical performance.

Multiple clinical, biological or radiological tools were proposed. Our purpose is to compare the post-operative outcome of sarcopenic and non sarcopenic patients using a simple, available, reproducible and rapid radiological method, which will help the healthcare professionals to rapidly identify high risk patients for possible complicated and long post-operative course allowing them to take appropriate perioperative measures to reduce the risks.

Eligibility Criteria:
Inclusion Criteria:

* Patient operated on for colectomy or proctectomy with restoration of continuity for colorectal cancer between 1 January 2020 and 31 December 2021
* Patient who had a CT scan in the 2 months prior surgery
* Patient aged 18 years or older

Exclusion Criteria:

* Patients with inflammatory bowel disease (Crohn disease, haemorrhagic rectocolitis)
* Patients with neuromuscular pathology affecting their mobility
* Patients who were diagnosed positif to SARS COV 2 before or during hospitalisation
* Patients who refuse the collection of their data
Life After Sport: Prior Injury and Sedentary Behavior as Mechanisms of Later Poor Health

Competitive sport increases risk for musculoskeletal injury (e.g., traumatic knee injury) and may position former athletes for early onset of chronic diseases, chronic pain, poor health-related quality of life, and disability. Quantifying function in former athletes with and without a prior injury and non-athlete controls is critical to understanding long-term health trajectories in athletes and informing potential interventional studies. One modifiable factor that may be associated with long-term health in athletes is physical activity patterns. The purpose of this study is to evaluate strength, function, physical activity, dietary patterns, and cardiometabolic health among current and former competitive athletes and in nonathlete controls to evaluate the impact of prior knee injury and sedentary behavior as two potential determinants of later poor health and reduced function.

The overarching hypothesis is that former athletes, especially those with a prior injury, will have poorer function and health in midlife and that current and former athletes will engage in greater overall and longer bouts of sedentary behavior compared to non-athletes.

Aim 1 will compare function, strength, and cardiometabolic indicators among former athletes with and without prior knee injury and non-athlete controls in midlife (age 40-64). Hypothesis 1 is that former athletes with a prior injury will have the poorest function, muscle strength, and cardiometabolic indicators.

Aim 2 will compare sedentary behavior and physical activity patterns in current (age 18-25) and midlife former athletes to non-athlete controls. Hypothesis 2.1 is that current athletes will have greater sedentary behavior, longer sedentary behavior bouts, and higher levels of moderate-to-vigorous physical activity compared to non-athlete controls. Hypothesis 2.2 is that former athletes in midlife will have greater sedentary behavior, longer sedentary behavior bouts, and lower physical activity levels compared to non-athlete controls.

An exploratory aim will evaluate longitudinally the trajectory of physical activity patterns, cardiometabolic indicators, function, and strength annually in each cohort, comparing how these variables change over time in each subgroup.

Eligibility Criteria:
Please see cohorts for specific inclusion/exclusion criteria

Inclusion Criteria:

* Age 18-25 years OR age 40-64 years
* Current or former collegiate varsity athlete OR non-athlete control

Exclusion Criteria:

* Neurologic (e.g., stroke, Parkinson's) and/or degenerative disease that impairs function
* Pregnancy
* Lower extremity joint replacement (e.g., hip or knee replacement)
Retrospective Study in Sarcoma Patients

The objectives of this trial is to evaluate efficacy and safety of treatment with Trabectedin in a large cohort of German patients with soft tissue and bone sarcomas.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed soft tissue or bone sarcomas treated with at least one cycle of Trabectedin in any line of therapy.
* Age ≥18years at start of therapy with Trabectedin
* Informed Consent
* Patients already deceased may be included when the treating physician is able to determine the presumptive consent

Exclusion Criteria:

* No follow-up data available
The Impact of Arousal Threshold in Obstructive Sleep Apnea

The investigators hypothesis is that obstructive sleep apnea (OSA) patients with a low arousal threshold may wake up too early during a respiratory event, before upper airway muscles can be activated to achieve stable ventilation. Thus, strategies to manipulate the respiratory arousal threshold could potentially improve the quality of sleep and sleep disordered breathing. Agents that raise arousal threshold are therefore likely to benefit some patients with OSA. The overall goal of this project is to determine the importance of the arousal threshold in OSA, determine which patients might benefit from a raised arousal threshold, and test this hypothesis by using pharmacological manipulation of the arousal threshold to achieve this goal.

This study is a pilot study. The investigators will test whether donepezil has important effects on the arousal threshold and on the apnea hypopnea index.

Donepezil is a cholinesterase inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of symptoms of Alzheimer's disease.

Eligible participants will undergo overnight polysomonography as described below and will receive either donepezil (10 mg immediately prior to sleep) or placebo (in random order) followed roughly 14 days later with placebo or donepezil. This aim will allow us to test the impact of donepezil on the apnea hypopnea index. The study plans to enroll approximately 30 subjects.

The change in apnea hypopnea index as well as arousal thresholds/upper airway mechanics will be compared in the donepezil groups with the placebo group.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-70 years
* sleep study (with apnea hypopnea index\>5)
* Diagnosis of obstructive sleep apnea

Exclusion Criteria:

* Any known unstable cardiac (apart from treated hypertension), pulmonary (including asthma), renal, neurologic (including epilepsy), neuromuscular, or hepatic disease.
* Susceptible to stomach ulcers.
* Pregnant women or Nursing mothers
* Using positive airway pressure (PAP) therapy over one week or longer
* Body weight \<55kg
* History of hypersensitivity to Afrin, Lidocaine and/or Donepezil
* History of bleeding diathesis and/or gastrointestinal bleeding.
* Use of any medications that may affect sleep or breathing.
* A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders.
* Substantial cigarette (\>5/day), alcohol (\>3oz/day) or use of illicit drugs.
* More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day.
* Deprived from sleep in the recent one week
* Desaturations to below 70% lasting greater than 10 seconds in duration per event in the sleep study (without Oxygen).
Valuation of Variable Dose of Docosahexanoic Acid for the Improvement of the Parameters of Male Fertility

Sperm parameters will be examined before DHA (DHA=Docosahexanoic Acid) consumption, after one months and after 2 months taken Docosahexanoic Acid or placebo.

Prospective, randomized, double blind, placebo-controlled intervention study within individuals. Assisted reproduction unit and academic research laboratory. One hundred an eighty human semen samples from 60 infertile patients of IVI Sevilla clinic were finally included. Assessment of oxidative stress, apoptosis, lipid peroxidation, mitochondrial membrane potential, DNA fragmentation and standard sperm parameters before and after supplementation with different DHA doses (0.5, 1 and 2 g) or placebo for 1 and 3 months.

Eligibility Criteria:
Inclusion criteria:

* 1 year of infertility
* \> 10 mill/ml of sperms
* Motility \< 60% progressive
* Morphology \< 2% (WHO 2010)

Exclusion criteria:

No meeting the inclusion criteria.
Establishment of the National Registry for Inherited Retinal Dystrophy in Iran

Purpose: To establish of the national Inherited Retinal Dystrophy Registry (IRDR) in Iran.

Methods: This study is a community-based participatory research that is approved by the Ministry of Health and Medical Education of Iran in 2016. To provide the minimum data set (MDS), several focus group meetings will be held with participation of the faculty members of the Ophthalmic Research Center affiliated to Shahid Beheshti University of Medical Sciences (SBMU). Final MDS will be presented to the software engineering team to develop a web-based software. In the pilot phase, software will be set up in two referral centers including Labbafinejad Medical Center (Tehran) and Alzahra Eye Hospital (Zahedan) to discover the possible drawbacks. Final diagnosis will be made based on both clinical manifestations as well as genetic findings.The steering committee meetings are planned to be held each year with the presence of delegates of all centers.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a definite diagnosis of IRD diagnoses based on clinical examinations and genetic testing.

Exclusion Criteria:

* Individuals who have a suspected diagnosis of IRD disease
Intra-operative Assessment of the Intellirod LOADPRO Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery

The LOADPRO Study is an intra-operative, non-significant risk (NSR) case series feasibility assessment of the Intellirod LOADPRO™ System measuring spinal rod strain in long spinal kyphotic corrective constructs.

The Intellirod LOADPRO™ sensor is an intra-operative titanium and ceramic, single use, disposable, strain sensing device, which includes hermetically sealed, micro electromechanical systems (MEMS) and radio-frequency identification (RFID) technology to enable measurement of intra-operative rod strain values. The transponder attaches to any commercially available 5.5mm diameter CoCr or Ti Alloy rod commonly used for posterior pedicle fixation systems. The transponder is used only to acquire rod strain values and a unique device identification code, which is obtained by a hand-held reader, providing real-time, objective measurement of the mechanical rod strain.

This non-significant risk case series is intended to assess the effectiveness of the Intellirod LOADPRO™ sensor methodology and the intra-operative measurement of spinal rod strain. The LOADPRO™ sensors will be removed from the spinal rods after obtaining load measurements.

Eligibility Criteria:
Inclusion Criteria:

* between 18 and 65 years of age
* presenting with a confirmed diagnosis of kyphosis with deformity greater than 70 degrees requiring large segmental correction involving a minimum of six (6) levels
* failure of conservative therapy requiring surgical correction of sagittal imbalance
* sagittal imbalance due to loss of lumbar lordosis, and/or segmental kyphosis
* participated in the informed consent process and has signed an Institutional Review Board approved informed consent

Exclusion Criteria:

* women who are pregnant
* evidence of active (systemic or local) infection at time of surgery
* prisoner or transient
* history of known narcotic abuse
* psychological disturbance past or present that could impair the consent process or ability to complete subject self-report questionnaires
* ASA \> 3
* osteoporosis diagnosed on DEXA defined as a T-score ≥ -2.0
* Unable or unwilling to provide a full informed consent
Interval Training and Cardio-metabolic Health in Overweight/Obese Girls

The main purpose of this study is to compare the impact of 12-week moderate-intensity interval training (MIIT) versus combined MIIT with high-intensity interval training (HIIT) on physical fitness, cardio metabolic, lipidomic, hematological and psychological characteristics in young overweight/obese girls.


Eligibility Criteria:
Inclusion Criteria:

* Female gender,
* Overweight or obese according to the BMI classification,
* Age, 12 to 15 years,
* Personal or parental/guardian written consent

Exclusion Criteria:

* Severe infectious or inﬂammatory diseases,
* Irregular menstrual cycles
* Participation in organized exercise training in the last 6 months or additional physical -
* recreational activities, except physical education classes.
* Using medications, hormone therapy or dietary supplements
Management of Non-Organic Dysphonia in Adults.

The purpose of this study is to determine the effect of a semi-occluded vocal tract training program, "Resonant Tube Therapy," versus the "Traditional Smith-accent Method" on the quality of voice in patients with Non-Organic "Functional" dysphonia.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with non-organic functional dysphonia with or without Minimally Associated Pathological lesions and referred for voice therapy. The diagnosis was based on the results of the routine clinical assessment of cases of voice disorders by a phoniatrician in the voice clinic.
* Patients 'ages between 15 - 60 years old.
* Native speakers of Arabic.
* Language comprehension adequate for the task.

Exclusion Criteria:

* Patients with organic voice disorders.
* Patients with aphonia or Phon asthenia.
* Females within the week of their menstrual cycle or menstruating at the time of data collection to control for the possible hormonal effects or premenstrual water retention on voice quality.
* History of severe respiratory allergies, thyroid pathologies, neuro-motor impairment, hearing impairment, psychiatric problems and physically limiting diseases that might interfere with study completion.
* Those on any regular medication that might affect voice quality.
* Speech disorders.
* Cigarette smoking, alcohol, or drug abuse for the past 5 years.
* Patients with previous micro laryngeal surgery.
* Patients with gastrointestinal reflux disease.
Long-term Endoscopic Follow-up of Benign Epithelial Gastric Polyps

Benign epithelial gastric polyps are benign raised lesions that originate from the gastric mucosa or submucosa and protrude from the gastric cavity with a wide base or a pedicle.The diagnosis and treatment of benign epithelial gastric polyps are currently controversial. There is still a lack of clinical research evidence especially for the malignant tendency and related treatments of gastric polyps. Many doctors have ambiguous understanding of benign epithelial gastric polyps and their endoscopic management is still in a"one size fits all"mode in China, which greatly wastes medical resources and increases the medical risks of patients, So it is imminent to formulate management practices for the diagnosis and treatment of gastric polyps. Therefore, a full understanding of the clinical characteristics, endoscopic characteristics and long-term follow-up trends of benign epithelial gastric polyps is of great significance for clinicians to formulate reasonable treatment and follow-up plans. This study is a prospective, large-sample observational cohort study. It is planned to include 200 patients with biopsy confirmed benign epithelial gastric polyps participating in this study from September 10, 2020 to December 31, 2021 and followed up for 18 months. The main research endpoint is the correlation between size and pathological type of benign epithelial gastric polyps and polyps development. The secondary research endpoint is the correlation between type of benign epithelial gastric polyps and Helicobacter pylori infection. The research results will help provide long-term follow-up data for benign epithelial gastric polyps of different pathological types, thereby providing first-hand evidence-based medical data for formulating gastric polyp management guidelines, helping to efficiently screen high-risk groups and guiding their examination, treatment and long-term follow-up to achieve early detection and early treatment of gastric cancer, thereby reducing the mortality rate.


Eligibility Criteria:
Inclusion Criteria:

* After gastroscopy, gastric polyps are found and pathological biopsy is obtained.

All polyps undergo endoscopic clamp biopsy, requiring at least one piece of tissue from each polyp to be submitted for examination.

Exclusion Criteria:

* Submucosal raised lesions.
* Gastrointestinal bleeding.
* Concomitant with gastric malignant tumor disease or previous gastric surgery for any reason.
* Benign polyps with a diameter greater than 1cm, regardless of the pathological type.
* The patient also has other serious diseases that affect the evaluation of this study, such as severe liver disease, heart disease, kidney disease, malignant tumors and alcoholism.
* The patient cannot express his main complaint correctly, such as mental illness, severe neurosis, and cannot cooperate with the trial.
Effect of Phytochemicals on Aspects of Cognitive Performance

The primary purpose of the research is to test the short-term effects of the consumption of beverages containing phytochemicals and caffeine on several aspects of cognitive performance.


Eligibility Criteria:
Inclusion Criteria:

* Subjects should be older than 17 and under 50 years of age, self report of good health

Exclusion Criteria:

* Using any prescription medication including birth control;
* Report a history of any phschiatric condition;
* Report hypersinsitivity to caffeine;
* Have visual impairment that connot be corrected with glasses or contact lenses