cyrilzakka/clinical-trials huggingface dataset:
Laryngeal Reflex Study Under Propofol Anesthesia: Effect of Intravenous Lidocaine

To describe respiratory and laryngeal responses to laryngeal stimulation during propofol anesthesia in children. To determine whether the co-administration of lidocaine blunts these reflex responses. The outcome of primary interest is the reflex laryngospasm.

Hypotheses:

I: The severity of laryngospasm evoked by laryngeal stimulation is reduced 2 min. after iv. administration on 2mg/kg lidocaine in pediatric patients anesthetized with propofol (3mcg/ml).

II:The incidence of laryngospasm elicited by controlled stimulation 10min. after iv. administration of lidocaine is equivalent to the response before the administration of lidocaine.

Based on our previous work assessing the laryngeal reflex responses in children, the use of propofol appears to be promising regarding a low incidence of laryngospasm. Compared with a sevoflurane-based anesthesia, the incidence was found to be significantly lower, but there is a high incidence of other reflex responses, such as coughing and expiration reflexes. The use of lidocaine has been advocated to reduce the incidence of laryngospasm in anesthetized children. However, based on clinical studies its effectiveness in the prevention or attenuation of laryngospasm is controversial.

In a previous work using a established stimulation model (stimulating the laryngeal mucosa with a small amount of distilled water under direct fiberbronchoscopic observation), we observed a risk reduction of 60% of laryngospasm 2min. after the application of 2mg/kg bolus of lidocaine. This effect had already diminished after 10 min.

The laryngeal reflex responses differ largely in children anesthetized with either inhalational anesthetics or with propofol. The impact iv administered lidocaine on laryngeal and respiratory reflex responses in children anesthetized with propofol has not been assessed, although this combination might result in a profound suppression of laryngeal reflex responses.

Eligibility Criteria:
Inclusion Criteria:

* 25 - 84 months
* gender: female / male
* elective surgery or diagnostic procedure requiring general anesthesia

Exclusion Criteria:

* respiratory infection within the last 2 weeks
* reactive airway disease under therapy
* cardiovascular disease
* neuromuscular disease
* positive family history of malignant hyperthermia
* known hypersensitivity to the investigational medical product
* Participation in another study
* Inability of the parents to read and understand the participant's information
Study to Evaluate Efficacy and Safety of Oral Abexinostat in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

An open-label, single-arm, multi-center phase 2 study to evaluate the efficacy and safety of abexinostat, as monotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

An open-label, single-arm, multi-center phase 2 study to evaluate the efficacy and safety of oral histone deacetylase (HDAC)-inhibitor abexinostat, as monotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diffuse large B-cell lymphoma (DLBCL);
2. Have received only two prior standard therapy lines for diffuse large B-cell lymphoma (DLBCL) including anti- cluster of differentiation antigen (anti-CD20) antibody and cytotoxic therapy;
3. Confirmed to be unresponsive to the last line of therapy, or have disease progression following the last line of therapy;
4. Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion;
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
6. Meet various hematological, liver and renal function lab parameters.

Exclusion Criteria:

1. Have primary central nervous system (CNS) lymphoma or secondary central nervous system (CNS) infiltration, transformed lymphoma, unclassified B-cell lymphoma with features intermediate between DLBCL and classical Hodgkin's lymphoma (HL), primary effusion lymphoma, plasma lymphoma;
2. Toxicity not yet recovered from previous anti-tumor therapies;
3. Uncontrolled systemic infections or infections requiring intravenous antibiotics;
4. Have received steroid hormone, chemotherapy, targeted therapy, radiotherapy, antibody-based therapies, within a specified amount of time per protocol;
5. Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the intake, transport or absorption of the study drug;
6. Have received autologous stem cell transplant,or allogeneic stem cell transplant within a certain amount of time as specified in protocol;
7. Presence of active graft-versus-host reaction;
8. Have undergone a major surgery within the last month;
9. Evidence of possible human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection;
10. Have any cardiac impairment as defined per protocol;
11. Have prior history of malignancies other than diffuse large B-cell lymphoma (DLBCL).
Impact of Topical Pentoxifylline and Tocopherol in Treatment and Prevention of Medically-related Osteonecrosis of the Jaws

While there is no doubt about the benefits of antiresorptives, it is known that patients using these drugs are at increased risk of developing osteonecrosis of the jaws (MRNOJ), especially after oral procedures such as tooth extraction. The management of osteonecrosis has remained a controversial topic within the oral and maxillofacial surgery community.

The aim of the present study is to analyze the impact of topical pentoxifilline and tocopherol in the prevention and treatment of MRNOJ.

A double-blind randomized controlled clinical trial is conducted in order to evaluate the impact of topical pentoxifilline and tocopherol in the prevention and treatment of MRNOJ and determine the statistical significance of the outcome variables.

48 subjects with MRNOJ, randomly allocated in two groups: placebo group with a 4% hydroxyethyl cellulose adhesive gel and the treatment group with the same gel containing pentoxifilline 5% and tocopherol 75%.

Eligibility Criteria:
Inclusion Criteria:

* Correspondence to the updated SIPMO criteria for MRONJ diagnosis
* Need for tooth extraction

Exclusion Criteria:

* Recent use of antibiotics and anti-inflammatories in the last 4 weeks
* Oral lesions of hard and soft tissues not related to MRONJ
Hypotaurine Supplementation Benefits in Cryopreservation

Although it is widely used, slow freezing can induce strong functional and nuclear spermatic alterations reducing the chances of pregnancy. The study objective is to determinate the effects of the combination of hypotaurine supplementation and spermatozoa selection by Density Gradient Centrifugation (DGC) on human sperm functions and DNA quality during a freezing-thawing cycle.

This prospective study was performed on surplus semen after a density gradient centrifugation-frozen-thawing cycle. Samples were obtained from men undergoing routine semen analysis at the Center for Reproductive Medicine. Spermatozoa were selected by density gradient centrifugation, washed and frozen using a programmable device. Each step was performed in parallel with (H+ arm) or without (H- arm) 50mM hypotaurine supplementation. After thawing, investigator team compared for both conditions the total and progressive mobility, vitality, integrity of the acrosome, markers of Protein Kinase A (PKA) dependent capacitation intracellular signaling pathway and nuclear quality by measuring chromatin packaging, DNA fragmentation and oxidation and vacuoles presence in the spermatozoa head.

Eligibility Criteria:
Inclusion Criteria:

* None

Exclusion Criteria:

* None
Aging and Cancer Effects (ACE) Study

Hypotheses:

1. Subjective self-reported data can be used to accurately reflect functioning across the 5 key domains.
2. Cancer and its various treatment modalities will exert detrimental effects on the 5 key domains in older adults with cancer.
3. Some aspect of baseline patient characteristic will be predictive of cancer-related outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Willing to do memory testing
* Willing to participate in activities of daily living assessment
* Can use a cane or walker
* Willing to complete a balance performance assessment, if able.

Exclusion Criteria:

* Currently receiving treatment for cancer.
* Has a previous history of brain cancer
* Significant neurological disease other than AD that might affect cognitive function, such as stroke, Parkinson's disease, multiple sclerosis, or serious traumatic brain injury.
Intracerebral Gene Therapy in Children With Sanfilippo Type B Syndrome

This is an open-label, phase I/II study of intra-cerebral administration of adenovirus-associated viral vector containing the human NAGLU cDNA to children suffering from Sanfilippo type B syndrome.

This is an open-label, phase I/II study of intra-cerebral administration of adenovirus-associated viral vector containing the human NAGLU cDNA to children suffering from Sanfilippo type B syndrome.

Four patients, 18 months up to the 5th birthday, have been included.

The inclusion period will be 8 to 12 months. The duration of follow-up for each patient is 1 year post-surgery. The duration of the first extension phase is 18 months. The duration of the second extension phase is 36 months. Therefore, the maximum time of the follow-up will be 66 months

Eligibility Criteria:
Inclusion criteria:

* Age: 18 months up to 60 months (5th birthday);
* Onset of clinical manifestations related to mucopolysaccharidosis type IIIB (MPSIIIB);
* NAGLU activity in peripheral blood cell and/or cultured fibroblast extracts of less than 10% of controls;
* Patient affiliated to, or covered by a French social security regimen, or European patients with European Health Insurance Card;
* Family understanding the procedure and the informed consent;
* Signed informed consent by both parents or legal representative;
* Vital laboratory parameters within normal range.

Exclusion Criteria:

* Presence of brain atrophy on baseline MRI judged on a cortico-dural distance of more than 0.6 cm;
* Any condition that would contraindicate general anesthesia;
* Any other permanent medical condition not related to MPSIIIB that could contraindicate the study participation;
* No independent walking (ability to walk without help);
* Any medication aiming at modifying the natural course of MPSIIIB given during the 6 months before vector injection (sleep and mood regulators are accepted);
* Any condition that would contraindicate treatment with Modigraf®, Cellcept® and prednisolone (Solupred® and Solumedrol®).
Human Sperm Binding to Transgenic Mouse Eggs

At fertilization, the binding of sperm to the zona pellucida induces the acrosome reaction releasing lytic enzymes that facilitate the passage of the sperm through the zona. The sperm then fuses with the egg's plasm membrane and enters the egg's cytoplasm. The zona pellucida, an extracellular matrix composed of three glycoproteins (ZP1, ZP2, ZP3), mediates the species-specific binding of sperm to egg. Although homologous proteins are present in mouse and humans, human sperm will not bind to the mouse zona pellucida and when the zona pellucida is experimentally removed, human sperm will not bind or fuse to the mouse egg's plasm membrane. We have created transgenic mouse lines that express one or more human zona proteins. We wish to determine if human sperm will bind to these chimeric zonae and if this binding will induce the human sperm acrosome reaction. Sperm and devitalized eggs will be collected by collaborating institution(s) under protocols and consent forms approved by that institution's IRB. Only procedures already being performed on subjects for diagnostic or treatment purposes will be used.

At fertilization, the binding of sperm to the zona pellucida induces the acrosome reaction releasing lytic enzymes that facilitate the passage of the sperm through the zona. The sperm then fuses with the egg s plasma membrane and enters the egg s cytoplasm. The zona pellucida, an extracellular matrix composed of three or four glycoproteins, mediates the species-specific binding of sperm to egg. Although homologous proteins are present in mouse and humans, human sperm will not bind to the mouse zona pellucida and when the zona pellucida is experimentally removed, human sperm will not bind or fuse to the mouse egg's plasma membrane. We have established transgenic mouse lines that express one or more human or rat zona proteins. We wish to determine if human sperm will bind to these chimeric zonae and if this binding will induce the human sperm acrosome reaction. Sperm and devitalized eggs will be collected by collaborating institution(s) under protocols and consent forms approved by that institution's IRB. Alternatively, anonymous fertile human sperm will be obtained from a commercial sperm bank using a donor consent agreement. Only procedures already being performed on subjects for diagnostic or treatment purposes will be used.

Eligibility Criteria:
* INCLUSION CRITERIA:

Without regard to ethnic/race background, all subjects will be men and women over the age of 18 who are neither mentally retarded nor disabled.
An Alternative Treatment for Cervical Intraepithelial Neoplasia Using the Focal Loop Electrosurgical Excision Procedure

This is a pilot study to test the short-term effectiveness of an alternative treatment approach for precancerous cells of the cervix. The study will also explore whether this new treatment is feasible to perform and if it is acceptable to patients.

Standard treatment for precancerous cells of the cervix is called electrosurgical excision procedure (LEEP). Standard LEEP involves treating the entire cervix using FDA-approved equipment. Focal LEEP utilizes the same surgery and the same equipment but only treats the visually unhealthy part of the cervix and not the entire cervix. Side effects and unusual symptoms will be monitored as well as the patient's thoughts and recommendations of the procedure. The total amount of time of study participation is six months.

Eligibility Criteria:
Inclusion Criteria:

* Age 21-45 years old
* Histologically confirmed high-grade cervical intraepithelial neoplasia (CIN2, CIN3, or CIN2/3). A copy of the pathology report is required at the time of enrollment. We will only include patients that had their biopsy performed at the UAB Colposcopy clinic because those that return for treatment represent a select group that is more reliable for follow-up given the standard no-show rate of 50% at the clinic.
* Focal lesion visualized in its entirety colposcopically and involving less than or equal to 2 quadrants of the cervix.
* Satisfactory (adequate) colposcopy.
* Lives within 100 miles of the University of Alabama at Birmingham.

Exclusion Criteria:

* Any suspicion for invasive cancer.
* Glandular abnormalities on cytology or histology.
* Cervical lesion incompletely visualized (e.g. extending into the endocervical canal).
* Endocervical curettage positive for high-grade cervical intraepithelial neoplasia.
* Unreliable for follow-up (drug use, planning to move out of region, etc.). Any patient that lives \>100 miles away will be excluded due to concern for possible loss to follow-up.
* Immunosuppression (HIV positive, history of transplantation, lupus on immunosuppressive medication, etc.).
* Pregnancy.
* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
SilverCloud as a School-Based Intervention for Vulnerable Youth

The goal of this study is to test the efficacy and feasibility of a clinician-guided, app-based cognitive behavioral therapy (CBT) program, SilverCloud, as a school-based mental health intervention for vulnerable youth. An open trial of SilverCloud will be conducted to determine preliminary efficacy in this sample and inform program refinements by collecting outcome self-report assessments and conducting interviews on feasibility and acceptability. After the program and its implementation strategy are refined, we will conduct an randomized controlled trial. Adolescents who seek or are referred for mental health services through one of the study sites and screen positive for significant mental health symptoms will be randomized to receive SilverCloud or treatment as usual (TAU). Efficacy will be assessed through outcome self-reports. Feasibility and acceptability feedback will again be collected from participants, SBHC staff, and community members.


Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in the phase I open trial of this study, an individual must meet all of the following criteria:

* Enrolled in a high school
* Score of 10+ on GAD-7 or PHQ-9
* Speak/read English. The current investigational version of SilverCloud that will be used in this study is only available in English.

In order to be eligible to participate in the RCT of this study, an individual must meet all of the following criteria:

* Enrolled in 9th through 11th grades.
* Score of 10+ on GAD-7 or PHQ-9
* Enrolled in one of the study sites
* Speak/read English. The current investigational version of SilverCloud that will be used in this study is only available in English.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in the phase I open trial of this study:

* Does not use a smartphone
* Mental health concerns for which intensive treatment is indicated. Because SilverCloud has not been evaluated in people with serious mental illness, participants who exhibit symptoms of mania or psychosis will be referred to a higher level of care.
* Current suicidal ideation with intent. Participants who have a suicide plan and intent to act on it will be referred to the SBHC suicide risk protocol and will not be eligible until their suicidal thoughts have abated.

An individual who meets any of the following criteria will be excluded from participation in the RCT of this study:

* Current (within 1 month of enrollment) mental health treatment at one of the study sites
* Does not use a smartphone
* Mental health concerns for which intensive treatment is indicated. Because SilverCloud has not been evaluated in people with serious mental illness, participants who exhibit symptoms of mania or psychosis will be referred to a higher level of care.
* Current suicidal ideation with intent. Participants who have a suicide plan and intent to act on it will be referred for crisis intervention through the site at which they were referred and will not be eligible until their suicidal thoughts have abated.
TSTstarr + for Treatment of Severe Prolapsed Hemorrhoids --- a Multi-center Randomized Controlled Clinical Trail

TSTstarr+ in the treatment of severe hemorrhoids prolapse--A multi center randomized controlled clinical trial.The aim of this stuy is to compare the first year hemorrhoids recurrence rate of TSTstarr+ and PPH in the treatment of severe hemorrhoids.


Eligibility Criteria:
Inclusion Criteria:

* severe prolapsed hemorrhoids
* no significant anal-malformation before operation
* having signed the informed consent.

Exclusion Criteria:

* needing emergency operation or having previous history of hemorrhoids operation
* with other anal diseases at the same time such as : anal fissure, anal fistula and perianal abscess and so on
* diagnosed with inflammatory bowel disease or proctitis
* diagnosed with colorectal cancer
* associated with cardiovascular and cerebrovascular diseases and other diseases so that can not tolerate surgery or increase the risk of surgery
* with chronic or acute renal insufficiency patients
* coagulation abnormalities or with anticoagulation treatment at present
* diagnosed with diabetes with poor glycemic control
* in women with pregnant or menstruation
* The intellectual disabilities or mental disorder
* had participated in other clinical trial before we selected 4 weeks
* other severe complications.
Comparing Double Dose of Vaginal Progesterone to no Treatment for Prevention of Preterm Birth in Twins and Short Cervix

Twin pregnancies are more likely to be delivered preterm than singleton pregnancies. Vaginal progesterone administration (200 mg Utrogestan) to asymptomatic women with a singleton pregnancy and sonographic short cervix reduced the risk of preterm birth (PTB) and neonatal morbidity and mortality, yet not proved efficient in twins' pregnancy. The investigators' hypothesis is that a higher dose of vaginal micronized progesterone will be more effective in preventing PTD. The objectives of the study is to compare the rate of preterm birth and perinatal morbidity and mortality in a twin pregnancy with short cervical length treated with vaginal 400 mg of micronized progesterone to no treatment. The study is Randomized, open label, of twin pregnancy between 16-26 weeks of gestation with cervical length under 25 mm. Women will be randomly assigned to either treatment or no treatment group. Progesterone treatment will be given until 36 weeks of gestation. Other management will be according to standard protocol.


Eligibility Criteria:
Inclusion Criteria:

* Twin gestation
* Certain dating (documented first trimester ultrasound, or a reliable menstrual date confirmed by an ultrasound performed before 20 weeks of gestation)
* Age \> 18 years
* Gestational age 16-26
* Cervical length\<25 mm
* Intact membranes
* Informed consent

Exclusion Criteria:

* Major malformation or chromosomal abnormality to at least one fetus
* Higher order pregnancy
* Mocochorional-monoamniotic twin
* Death of one fetus
* Cervical dilatation \>3 cm
* Chronic medical conditions that would interfere with study participation or evaluation of the treatment (e.g. seizures, psychiatric disorders, uncontrolled chronic hypertension, congestive heart failure, chronic renal failure, uncontrolled diabetes mellitus with end-organ dysfunction, active thrombophlebitis or a thromboembolic disorder, history of hormone-associated thrombophlebitis or thromboembolic disorders, active liver dysfunction or disease, known or suspected malignancy of the breast or genital organs)