cyrilzakka/clinical-trials huggingface dataset:
Establishment of Fibroid Tissue Bank

The purpose of this study is to collect information and tissue samples from women with uterine fibroids. The samples will be used to study genes, proteins and other substances in order to better understand the disease process and improve fertility and reproductive health.

Women who are scheduled to undergo hysterectomy, myomectomy or other surgery due to uterine fibroids or to an unusual variant of fibroid disease, such as HLRCC or benign metastasizing leiomyomatosis, may be eligible for this study.

Tissue samples are collected from participants during surgery. The samples are coded and catalogued for research use. Data collected regarding the surgery include the sample location, surgery type, reason for surgery and the primary and secondary diagnoses. Additional data collected about the participant include date of birth, race, ethnicity, weight, height, smoking status, information about menstrual cycles, medications and family history.

The long term goal of this protocol is to create a repository of well-characterized fibroid (leiomyoma) tissues in order to gather information that will lead to improved understanding of uterine fibroid growth and pathogenesis. It is expected that this initiative will eventually improve fertility and reproductive health of the millions of women who suffer from fibroids.

To address the need for increased research in this field, the NICHD in collaboration with the Office of Research on Women s Health (ORWH) will establish a national fibroid tissue bank. This initiative will strengthen the science base, improve our understanding of how uterine fibroids develop and grow, and provide clues to more effective conservative management of fibroids. The rationale for this protocol is that a repository of well-characterized, well-preserved leiomyoma tissues will provide investigators interested in basic and translational research on fibroids the opportunity to study the condition. This will facilitate research because experiments conducted on the samples may be expected to improve understanding of the mechanism and pathophysiology of this disease.

Eligibility Criteria:
* INCLUSION CRITERIA:
* Women aged 21-80 with uterine fibroids
* Medically indicated hysterectomy, myomectomy or other surgery for uterine fibroids.
* Samples from patients with unusual variants of fibroid disease (HLRCC, benign metastasizing leiomyomatosis) will be included. These samples may possibly not arise from the uterus proper, as the leiomyoma may have become located elsewhere in the body.

EXCLUSION CRITERIA:

* Inability to give consent or understand the consent forms.
* HIV-infected tissues will be excluded due to concern of equipment contamination.
* Hepatitis-infected tissues will be excluded due to concern of equipment contamination.
Blood Flow Restriction Training in Patients With Weight Bearing Restrictions After Knee Surgery

After a cartilage or meniscus repair in the knee joint, the patients experience a pronounced and persistent decrease of knee-extension strength in the operated leg, which negatively affect patients' functional performance and quality of life. A possible novel exercise modality to increase muscle strength early is a moderate blood flow restriction with low-load strength training (BFR-LLST) exercise. BFR-LLST involves application of a wrapping device to restrict the blood flow to the muscle(s) during exercise. BFR- LLST requires much less load than traditional strength training and has shown to produce positive training adaptations such as muscle hypertrophy and strength in the lower extremity in healthy subjects and patients with a knee surgery. To our knowledge, early rehabilitation with BFR-LLST has never been investigated in a population with weight bearing restrictions, such as patients recovering from cartilage or meniscus repair in the knee joint. Fear of symptom exacerbation and adverse events have precluded BFR-LLST early after knee surgery. The purpose of this study is to examine the feasibility of 9 weeks of supervised rehabilitation with BFR-LLST early after cartilage or meniscus repair in the knee joint.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a cartilage and/or meniscus repair in 1 or 2 knee(s).
* Patient is between 18 and 70 years.
* Patient is able to speak and understand Danish.
* Patient has given informed consent to participate in the study.

Exclusion Criteria:

* Patient has problems that severely limits ambulatory function from unstable orthopaedic (besides cartilage repair and meniscal fixation in the knee joint), neurological, vascular or cardiac conditions.
* Patient has a history of diagnosed major psychiatric disorder.
* Patient has a history of illicit drug use; be currently abusing alcohol or currently withdrawing from alcohol abuse.
* Patient has a history of endothelial dysfunction, peripheral vascular disease, hypertension, diabetes.
* Patient has a history of heart disease and deep vein thrombosis.
* Patient is pregnant.
* Patient has cancer (current diagnosis).
* Patient has an active infection.
Safety and Performance of the Covidien EEA Hemorrhoid and Prolapse Stapling Set in a Hemorrhoidopexy Procedure

Trial Objectives

The primary objectives of this clinical trial are to estimate the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set:

overall performance defined by the successful creation of a normal staple line safety as measured by the 30 day incidence of adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand and sign Informed Consent Form
* The participant must be 18-80 years of age.
* The participant has (symptomatic) Grade 2-4 Hemorrhoids and is eligible for stapled hemorrhoidopexy.

Exclusion Criteria:

* The procedure is needed as revision hemorrhoid surgery.
* The participant is pregnant.
* The participant has an active or a history of infection requiring antibiotics at the intended operative site within thirty (30) days prior to the planned surgery date.
* The participant is unable or unwilling to comply with the study requirements, follow-up schedule.
* The participant has a history of drug or alcohol abuse.
* The participant has a history of venous thrombosis or pulmonary embolism.
* The participant has a history of coagulopathy.
* The participant is taking aspirin, anti-coagulation and/or anti platelet therapies (e.g.: Warfarin, Levonox) within the last 7 days prior to the planned surgery date
* The participant has a history of fecal incontinence.
* The participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for the study.
Mirtazapine for Acute and Chronic Post Mastectomy Pain

Our aim in this study will be to investigate the effect of mirtazapine on acute post-mastectomy pain manifested by total morphine consumption in first 24 hours and VAS score at rest and movement (primary outcomes). chronic neuropathic pain using LANSS Pain Scale (Leeds Assessment of Neuropathic Signs and Symptoms) and to evaluate the quality of recovery using the quality of recovery-40scoring system(QoR-40) (secondary outcomes) following modified radical mastectomy for breast cancer.


Eligibility Criteria:
Inclusion Criteria:

female patients aged 20-70 years scheduled for modified radical mastectomy with axillary dissection for breast carcinoma

Exclusion Criteria:

* known allergy to the study drugs significant organ dysfunction drug or alcohol abuse epilepsy patients with chronic pain or regularly receiving analgesics any psychiatric illness that would interfere with the perception and the assessment of pain
Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants

This is an open label, two period (fasted and fed), crossover study in up to 3 cohorts of 12 healthy adult participants per cohort (up to 36 participants in total). The pharmacokinetics (PK) of the inactive prodrug VNRX-7145, its active parent drug VNRX-5236, and ceftibuten will be evaluated after a single oral dose of ceftibuten/VNRX-7145.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults 18-65 years
* Males or non-pregnant, non-lactating females
* Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2
* Laboratory values meeting defined entry criteria

Exclusion Criteria:

* History of drug allergy or hypersensitivity to penicillin, cephalosporin, or β-lactam antibacterial drug
* Conditions that potentially alter absorption and/or excretion of orally administered drugs
* Congenital or acquired immunodeficiency syndrome
* Positive alcohol, drug, or tobacco use/test
Multicentre Trial to Evaluate the Safety and Efficacy of CP-316,311 in Major Depressive Disorder

A six week, fixed dose, double-blind, double-dummy, placebo, and active controlled, multicentre trial to evaluate the safety and efficacy of CP-316,311 in outpatients with major depressive disorder.

This study was terminated on March 17th, 2006. The results of the primary analysis at the interim showed that the CP-316,311 group was not significantly different than the placebo on the primary endpoint and therefore the data monitoring committee recommended termination of the trial. The decision to terminate the trial was not based on any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients with DSM-IV major depressive disorder

Exclusion Criteria:

* Women of child bearing potential
Effect of Antipsychotics on Appetite Regulation

The purpose of this study is to evaluate changes in appetite-regulating hormones, body composition (weight, body fat%), and hunger ratings in persons early in treatment with one of four atypical antipsychotic medications (olanzapine, risperidone, ziprasidone, aripiprazole).

Severe weight gain and glucose dysregulation are serious problems in patients treated with second-generation ('atypical') antipsychotics (SGA). These side effects frequently interfere with medication compliance and necessitate discontinuation of treatment. Although the causal mechanisms for weight and glucose dysregulation are not well understood, one promising area of investigation targets SGA-induced disturbances in appetite and in appetite-regulating hormones. Findings from our group (and others) demonstrate SGA treatment-related increases in fasting levels of the appetite-stimulating hormone, ghrelin, as well as increases in self-report hunger. This novel study will examine prospective changes in ghrelin and in the 'satiety-signaling' peptide YY (PYY) as measured before and after participants consume a standard mixed-macronutrient meal. Data are obtained at baseline (within 4 weeks of beginning medication), and again 2 months and 4 months later.

Eligibility Criteria:
Inclusion Criteria:

1. Meets DSM IV criteria for a psychotic disorder (schizophrenia, schizophreniform, brief psychotic disorder, schizoaffective disorder), bipolar disorder, or major depression with psychotic features;
2. "Drug naïve" prior to most recent psychiatric diagnosis;
3. Currently prescribed one of four atypical antipsychotic medications: olanzapine, risperidone, ziprasidone, or aripiprazole;
4. Between the ages of 18 and 40, any race and either gender;
5. Not obese (BMI \< 30 kg/m2) (fasting and postprandial ghrelin levels are altered in obesity);
6. Has negative histories for cardiovascular, metabolic, and endocrine disorders at screening;
7. Is willing and able to eat animal-derived foods; and
8. Is not exercising 3 or more times per week.

Exclusion Criteria:

1. Use of medications to treat metabolic and endocrine abnormalities, corticosteroids, over-the-counter appetite suppressants that contain phentermine or Sibutramine;
2. Active involvement with a weight loss program (i.e., Weight Watchers);
3. Serious or unstable medical illness which requires ongoing treatment with medication (this does not include hypertension);
4. Anemia;
5. At serious suicidal risk;
6. Current substance abuse or dependence;
7. For female subjects, pregnancy or nursing (because pregnancy may influence appetite and because the body composition procedure involves low level X-ray exposure).
8. Known history of mental retardation or dementia.
9. Children and adolescents under age 18 will be excluded owing to the inherent confounding effects of normal growth on body weight and appetite.
Open Trial of Telehealth Group for Improving Peer Relationships (PEERS) in NF1

This is an open trial of the UCLA PEERS protocol delivered via Telehealth with teens with neurofibromatosis type 1 whose parents report that they have difficulty making and keeping friends.


Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of neurofibromatosis type 1
* Age 12-17
* Main language spoken in the home is English
* Reliable internet access
* Current functional impairment in peer relationships
* Teen is interested and motivated to participate

Exclusion Criteria:

* Main language spoken in the home is not English
* Cognitive or developmental delays that affect reading comprehension or understanding of treatment material
* Significant behavioral concerns
* Other comorbid medical conditions
* Major surgery in past 6 months
* Prior social skills group treatment within past 6 months
* Prior participation in PEERS
Evaluation of the Know Your OQ™ Oral Health Literacy Tool in an Indian Population

This was a research study to evaluate the effectiveness of the questionnaire "Know Your OQ™" (Know Your Oral Health Quotient™) in changing people's level of knowledge about oral health in India and to evaluate the readability, understanding and ease of completion of the questionnaire "Know Your OQ™".


Eligibility Criteria:
Inclusion Criteria:

* Sign Informed Consent Form
* Male and female subjects aged ≥18 years old
* Availability of 10 days for completing the study
* Belong to NCCS (National Consumer Classification System) A,B
* Access to a cell phone, laptop, tablet or computer with internet/data connection
* Fluent in English
Madany Closure: A Novel Technique for Fascial Closure in Laparoscopic Surgery

this study aims to evaluate the effectiveness of the use of a basic laparoscopic instrument (Only needle holder) with a new technique for port site closure


Eligibility Criteria:
Inclusion Criteria:

* age . 18 years
* eligible for Laparoscopic cholecystectomy

Exclusion Criteria:

* refused to participate
Cross-linked CMC and Silk Proteins in Eye Disease

Data analyses and revision of the DED symptoms. A novel ophthalmic solution containing cross-linked CMC (CX-CMC) and Silk Proteins (SP) has been made available on the market.

Both molecules have been widely studied for their viscoelastic and hydrating, and wound healing properties.

This new ophthalmic solution is the first on the market formulated with a CX-CMC and SP.


Eligibility Criteria:
Inclusion Criteria:

* Subjects affected by dry eye disease

Exclusion Criteria:

* know allergies to CX-CMC
* know allergies to SP
Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife

Endoscopic submucosal dissection (ESD) is a relatively new modality for the treatment of superficial gastrointestinal neoplasia and especially in the diagnosis and treatment of submucosal tumors. ESD has become a minimal invasive alternative to surgery but requires a high degree of endoscopic skills to be performed safely, it is time consuming, and less safe than endoscopic mucosa resection.

New endoscopic instruments have been developed to increase the efficacy and safety of ESD, and a combined endoscopic instrument (HybridKnife) has been developed and evaluated with promising results in animal studies. This HybridKnife allows high-pressure water-jet (submucosal) dissection, as well as cutting and coagulation and makes ESD possible without changing instrument.

The purpose of this study is to evaluate the feasibility and safety of using HybridKnife for ESD in humans.


Eligibility Criteria:
Inclusion Criteria:

* Submucosal tumor (\< 4 cm)
* Mucosal tumor (T1) in patients unsuitable for surgery

Exclusion Criteria:

* Endoscopic ultrasound (EUS) or CT signs of metastasis
* Insufficient access to tumor
Phase I Safety and Immunogenicity Study of VAX102 [Flagellin.HuM2e] Influenza Vaccine in Healthy Adults

This study will evaluate the safety and immunogenicity of VAX102 \[Flagellin.HuM2e\], a recombinant, inactivated, subunit influenza vaccine given as a two dose regimen at a range of doses.

VAX102 is a cross-protective influenza A vaccine based on a recombinant protein expressed in E. coli. The protein comprises Salmonella typhimurium flagellin type 2 (STF2; TLR5 ligand) fused to Human M2e. The active component of the VAX102 vaccine is manufactured by a standard fermentation process. Unlike the HA and NA viral proteins, the amino acid sequence of M2e has remained remarkably stable in all human influenza A virus isolates. Thus an influenza vaccine based on the M2e antigen could elicit cross-protective immunity against most human influenza A virus strains. VAX102 vaccine relies on a single cross-reactive influenza A virus antigen manufactured by a recombinant protein fermentation-production process.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 18-49 years inclusive who provide written informed consent to participate.
* Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.

Exclusion Criteria:

* Presence of significant acute or chronic, uncontrolled medical or psychiatric illness
* Documented influenza infection in the 6 months prior to study entry.
* Presently receiving or history of receiving any medications or treatments that affects the immune system
* Acute disease within 72 hours prior to vaccinations Investigational product (test article) administrations will occur on Days 0 and 28 (± 3).
* In-clinic safety evaluations will be performed at screening, before each test article dose, and at Days 1, 7 (± 2), 14 (± 2), 29, 35 (± 2), 42 (± 2), 60 (± 2), 120 (± 7), and 180 (± 7).
* Completion of a Memory Aid for seven days following each vaccine dose will be requested of subjects for use in accurate recall of local and systemic reactions.
Sodium Management in Acute Neurological Injury

This multicenter, observational, study will enroll severe neurologically injured patients both prospectively and retrospectively. The aims are to identify the percent of neurocritical care patients with sodium levels ≤ 135 mEq/L, describe treatment strategies employed, determine the correlation of clinical factors (i.e. GCS, ICP) with serum sodium concentrations in patients prior to sodium altering therapy, and evaluate outcomes through evaluation of length of stay, discharge disposition, and modified Rankin score (mRS).


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years of age
* admitted to an intensive care unit for more than 48 hours
* ICD-9 codes for aneurysmal SAH, TBI, IPH, or intracranial tumor.

Exclusion Criteria:
Minocycline and/or Omega-3 Fatty Acids Added to Treatment as Usual for At Risk Mental States

This is a randomized double-blind placebo controlled trial which aims to evaluate the efficacy and tolerability of minocycline and Omega-3 fatty acids for patients with ARMS. Specifically to determine whether the addition of minocycline and / or Omega-3 fatty acids to Treatment as Usual in an operationalized ARMS population in Pakistan:

Primary hypothesis is that the persons with ARMS who are prescribed minocycline and / or Omega-3 fatty acids will have reduced transition rates to psychosis over a one year follow up period (from baseline) compared with Treatment-As-Usual (TAU). The transition rates will be lowest in the group receiving minocycline and Omega-3 fatty acids in combination.

Secondary objective is to determine that the Persons with ARMS who are prescribed minocycline and / or Omega-3fatty acids in combination will have greatest symptom reduction compared with TAU.

This study will be a six-month intervention of minocycline and/or Omega-3 fatty acids added to TAU in patients with ARMS, using a randomised, placebo-controlled, double-blind factorial design.The study will be a four-arm trial: one arm will receive minocycline with TAU; the second arm will receive Omega-3 fatty acids with TAU; the third arm will receive both minocycline and Omega-3 fatty acids with TAU; the fourth arm will receive placebo with TAU.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female help seeking individuals aged between 16-35 years.
2. Meets at least one of the criteria for ARMS (see CAARMS Operationalized Intake Criteria section below).
3. Assessed as competent to provide informed consent.

Exclusion Criteria:

1. History ofpreviously experiencing a psychotic illness (treated or untreated).
2. IQ \< 70 and/or history of learning disability.
3. Any pre-existing inflammatory conditions e.g. rheumatoid arthritis.
4. Organic brain disease e.g. epilepsy.
5. treatment with an antipsychotic or mood-stabilising agent.
6. Prior history of intolerance or serious side effects (hepatotoxicity, photosensitivity, blood dyscrasias) to any of the tetracyclines or Omega-3 fatty acids.
7. Concomitant penicillin therapy or concomitant anticoagulant therapy.
8. Active substance abuse (except nicotine or caffeine) or dependence within the last three months, according to DSM-V criteria.
9. Treatment with warfarin or lamotrigine.
10. Current or previous treatment with tetracycline antibiotics or Omega-3 fatty acids in the preceding three months before study entry.
11. Current treatment with any anti-inflammatory medication.
12. Treatment with electroconvulsive therapy within the 12 weeks preceding the study.
13. Active expression of suicidal ideation (CAARMS item 7.3 severity score 6) or current aggression/dangerous behaviour (CAARMS item 5.4 severity score 6). 14. Relevant current or past hematologic, hepatic, renal, neurological or other medical disorder that in the opinion of the principal investigator may interfere with the study.

15. Pregnant or breastfeeding females.
Application of Hyperoxygenated Fatty Acids in a Surgical Wound After Laparoscopic Cholecystectomy.

TITLE:

Application of hyperoxygenated fatty acids (PrevOmega) in a surgical wound of the umbilical trocar after laparoscopic cholecystectomy with placement of prostheses in patients with risk factors.

OBJECTIVE: This study aimed to evaluate the effect of topical application of hyperoxygenated fatty acids (AGHO), PrevOmega, at the umbilical trocar level after laparoscopic cholecystectomy with prosthesis placement, regarding its non-application, on the infection rate. of the surgical site (ISQ) and eventration of the trocar orifice (EOT), in patients with risk factors for ISQ AND EOT.

METHODS: A prospective, double-blind, randomized study was performed in patients operated on for scheduled cholelithiasis, who also had any of the following risk factors that increase the appearance of SSI or OOT: BMI\> 30kg / m2, Diabetes Mellitus, age\> 65 years and Chronic Obstructive Pulmonary Disease. Group A was administered physiological saline (SSF) at the umbilical trocar level at the end of the intervention versus the administration of PrevOmega to group B. The study was carried out between January 2018 and January 2020 and is registered in the European Database of Clinical Trials with the EudraCT Code: 2018-002260-67.

This study aimed to evaluate the effect of topical application of hyperoxygenated fatty acids (AGHO), PrevOmega, at the umbilical trocar level after laparoscopic cholecystectomy with prosthesis placement, regarding its non-application, on the infection rate. of the surgical site (ISQ) and eventration of the trocar orifice (EOT), in patients with risk factors for ISQ AND EOT.

Eligibility Criteria:
Inclusion Criteria:

Patients with ages between 18 and 90 years who underwent elective laparoscopic cholecystectomy for symptomatic cholelithiasis and who also presented any of the following risk factors for SSI or EOT were included:

* Obesity with body mass index (BMI)\> 30kg / m2
* Diabetes Mellitus (insulin dependent or oral antidiabetic takers)
* Age (\> 65 years)
* Chronic Obstructive Pulmonary Disease (COPD in treatment with inhalers).

Exclusion Criteria:

* Non-compliance with the inclusion criteria
* Conversion to laparotomy during the intervention
* Non-acceptance by the patient to participate in the study,
* Loss to follow-up.