cyrilzakka/clinical-trials huggingface dataset:
Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations

A new endovascular route for the treatment of brain AVMs may be possible in some cases: Trans-Venous Embolization (TVE). The technique uses microcatheters to navigate to the draining veins of AVM, to reach and then fill the AVM nidus retrogradely with liquid embolic agents until the lesion is occluded. This technique has the potential to improve on some of the problems with the arterial approach to AVM embolization, such as a low overall occlusion rate. However, by occluding the vein first, and filling the lesion with the embolic agent in a retrograde fashion, the method transgresses a widely held dogma in the surgical or endovascular treatment of AVMs: to preserve the draining vein until all afferent vessels have been occluded. Nevertheless, the initial case series have shown promising results, with high occlusion rates, and few technical complications.

The method is increasingly used in an increasing number of centers, but there is currently no research protocol to guide the use of this promising but still experimental treatment in a prudent fashion. Care trials can be designed to offer such an experimental treatment, taking into account the best medical interests of patients, in the presence of rapidly evolving indications and techniques.


Eligibility Criteria:
Inclusion Criteria:

* Any patient harboring a brain AVM (ruptured or unruptured) in whom TVE is considered a promising but yet unproven therapeutic option by the participating clinicians can be submitted to the Case Selection Committee.
* Patients must be in stable, non-urgent clinical condition, with the acute phase of the AVM rupture resolved (where applicable).
* Case must be approved by the CSC.

Notes on potentially suitable cases:

1. Current indications may include (but are NOT restricted to) brain AVMs with a small \<3 cm nidus (or small residual nidus), with a single draining vein, and for which curative treatment can be attained with one or at most two treatment sessions.
2. Physicians are not required to submit cases prior to any or all treatment; a case can be submitted to the CSC for consideration after previous treatments (including previous arterial embolization sessions) have been performed. The timing of the submission of the case will be left to individual operators. Previously treated AVMs (by any other modality: embolization/surgical resection/radiosurgery) are not excluded from TATAM.

Exclusion Criteria:

* Absolute contra-indication to endovascular treatment or anesthesia.
* Inability to obtain informed consent.
Arsenic Trioxide in Treating Patients With Urothelial Cancer

Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent cancer of the bladder or urinary tract. Arsenic trioxide may kill tumor cells that have become resistant to standard chemotherapy regimens.

PRIMARY OBJECTIVES:

I. To determine the efficacy of arsenic trioxide in patients with measurable urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.

II. To determine the toxicity of arsenic trioxide administered to patients with urothelial cancer.

OUTLINE:

Patients receive arsenic trioxide IV over 1 hour on days 1-5. Treatment repeats every 28 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response receive 2 additional courses.

Patients are followed every 2 months for 1 year after registration and then every 6 months for 1 year or until disease progression or relapse.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of transitional cell carcinoma of the bladder, urethra, ureter or renal pelvis; histologic documentation of metastatic/recurrent disease is not required; clinical staging, but not pathological staging, is required
* Patients must have relapsed from or failed to achieve a complete or partial response after one chemotherapy regimen, which must have included one of the following chemotherapy agents: cisplatin, carboplatin paclitaxel, or gemcitabine
* \>= 4 weeks since prior RT or chemotherapy
* Patients must have measurable disease
* CTC (ECOG) Performance Status =\< 1
* No evidence of NYHA functional class III or IV heart disease
* Baseline EKG with QTc \< 500 ms
* Non-pregnant and not nursing, as chemotherapy is thought to present substantial risk to the fetus/infant; men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while in this study
* Granulocytes \> 1500/ml
* Platelet count \> 100,000/ml
* Bilirubin =\< Upper limits of normal (ULN)
* Serum Creatinine \< 2.0 x ULN
Prediction of Pain During Old People Care Measured by Skin Conductance

The purpose of the project is to validate the use of Pain Monitor™ device, not invasive and simple of employment, for old people able to answer to a digital scale of pain intensity.

The main objective is to develop and to validate a model of prediction of the pain in old subject at the time of the care, using the measure of variation of the skin conductance.


Eligibility Criteria:
Inclusion Criteria:

* hospitalized patient;
* patient over 65 years of age;
* communicating, without cognitive impairment;
* having to undergo an act presumed to be painful during which the patient's mobility is limited: nursing care (removal of a drain, dressing of a chronic wound, urinary catheterization, etc.), medical examination, etc.;
* benefiting from a social security scheme or having rights;
* having given their prior informed written consent;
* person able to read.

Exclusion Criteria:

* cutaneous anomaly on the site of measure;
* pacemaker or internal defibrillator;
* extremities twitching;
* Treated by neostigmine.
Investigation of MP Pollution in the Human Respiratory System and Its Relationship to Lung Cancer

This project will study and characterize Microplastic (MP) burden in the lungs of patients undergoing Bronchoalveolar Levage (BAL) in thoracic clinics at Moffitt.


Eligibility Criteria:
Inclusion Criteria:

* English or Spanish-speaking patients scheduled for bronchoscopy/bronchoalveolar lavage (BAL) in thoracic clinics at Moffitt.

Exclusion Criteria:

* Patients with a known prior history of lung cancer or that have undergone a Bronchoalveolar Lavage (BAL) procedure at any time in the past in the involved lung targeted for BAL.
* Patients that have had any prior lung or thoracic or surgeries or procedures (examples: removal of lung or portions of the involved lung (lobectomy, pneumonectomy, wedge resection/segmentectomy).
* Patients with specimens that are considered to be non-adequate as true Bronchoalveolar Lavage Fluid (BALF) (i.e., absence of alveolar macrophages) after pathologist's evaluation will be excluded from the study.
Neural Signatures of Processing the Temporal Features of Auditory Events: From Preterm Infancy to Adulthood

Premature neonates are able to discriminate phonemes and voice from 28wGA at a time the neuronal network establish contact between the environment and the cortical neurones. In the present monocentric study the investigators will analyse the response of the cortical network in premature aged between 25 and 36 wGA in response to auditory stimuli using High Resolution Electroencephalography and High Density Near Infrared Spectroscopy.

Neurodevelopmental disorders may be related to functional or structural disruption of the neuronal network organization at an early stage or later in the course of development. The disruption of the initial set-up could partially explain the prevalence of neurodevelopmental risks due to prematurity. The development period between 25 and 33 wGA corresponds to the period of very great prematurity and represents a key period of neurodevelopment in terms of structural and functional establishment of neuronal networks. One way to address the functionality of the neuronal networks is to evaluate the neural response to the exogenous stimuli and to interpret the mechanisms and the developmental status of the network in their ability to develop appropriate responses.

Eligibility Criteria:
Inclusion Criteria:

* full term neonates between 25 and 36 weeks gestational age

Exclusion Criteria:

* Neonates outside the age range
Assess Satisfaction of Patients and Physicians With Results of Yaz Plus Treatment for 13 Cycles

Local prospective multicenter non-comparative non-interventional observational study. It's planed to assess satisfaction of patients and physicians with results of Yaz Plus treatment for 13 cycles in real practice.

Non-interventional, Yaz Plus, Contraception, Assess satisfaction, Russian Federation.

Eligibility Criteria:
Inclusion Criteria:

* Female patients ≥ 18 years old
* Requiring contraception
* Prescribed with Yaz Plus for the first time

Exclusion Criteria:

* Contraindications for the use of Yaz Plus in accordance with the local product information
Open-label, Phase I/IIa Study of VAC-3S in HIV-1 Patients Who Showed an Immune Response to VAC-3S During IVVAC-3S/P1

The purpose of this study is to evaluate the safety and tolerability of VAC-3S in controlled HIV patients receiving standard of care antiretroviral treatment.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected patient,
* Age between 18 and 60 years,
* ART (Anti Retroviral Therapy) initiation ≥ 1 year ago,
* Plasma HIV RNA ≤ 200 copies/ml in the past 12 months,
* Plasma HIV RNA ≤ 50 copies/ml at the screening visit,
* CD4+ T cell count ≥ 200 cells/mm3,
* Nadir CD4+ T cell count ≥ 100 cells/mm3,
* Contraception in women with child-bearing potential,
* A total anti-3S titer ≥ 20 A.U. at any time point of IVVAC-3S/P1 clinical trial,
* Per protocol subject having completed the IVVAC-3S/P1 study.
* Patient affiliated to a social security system,
* Patient who has understood the protocol design and provided a signed written informed consent form,
* Patient who is willing and capable of cooperating to the extent and degree required by the protocol,
* Patient whom the investigator believes he/she can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) and he/she will be available for all scheduled visits at the investigational site.

Exclusion Criteria:

* Administration of VAC-3S in the past year,
* Chronic active liver disease,
* History of HCV co-infection or ongoing replicating HCV (positive RT-PCR) or HBV (positive HbS Ag) coinfection,
* Any immunotherapy (e.g. IL-2, IL-7, growth hormone...) in the past year at the exception of VAC-3S,
* Any immunosuppressive therapy (glucocorticoids, cyclosporine, methotrexate) or chronic non-steroidal anti-inflammatory treatment in the past month,
* Ongoing pregnancy,
* Breastfeeding women,
* Patient with known sensitivities to investigational drug (see please the CIB),
* History of allergy to any vaccine,
* Any severe chronic condition that would interfere with the study,
* History of auto-immune disease,
* Organ transplant,
* Splenectomy,
* Psychiatric disorder significant enough to hinder participation as assessed by the investigator,
* Patient who has participated in a clinical research trial in the 30 days preceding the screening visit (V-1M-1).
* Patients with contraindications to intramuscular injections including, but not limited to, patients with thrombocytopenia and/or anomalies of the coagulation system,
* Any uncontrolled chronic or acute condition that in the opinion of the investigator would compromise the safety of the patient or the ability to properly administer the study.
The Influence of Oral Probiotic on the Vaginal Flora and Microenvironment Alteration in the Vaginosis Infection Women

A single-blind, randomized, and probiotic-treatment including adult women with vaginitis and/or HPV positive. After oral probiotics, all participants will be followd-up cervical swabs and vaginal microbiome alteration till the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed as vaginal viginitis
* willing to sign permit
* willing to regular follow up

Exclusion Criteria:

* Pregnant
* Virgin
* Severe cervix pathology CINII or CIN III
* Confirmed cervical cancer
* under long term antibiotics due to other physical condition
Utilizing Advocates and Supporters to Increase Lung Cancer Screening Rates in Eligible Participants

This clinical trial assesses the use of advocates and supporters of breast and lung cancer screening to increase lung cancer screening rates amongst eligible participants. Imaging-based cancer screening is utilized with variable frequency. Breast cancer screening with mammography has been widely accepted and is commonly used among eligible women. Lung screening with computed tomography scans is poorly used, despite the potential to decrease deaths from lung cancer. There are many reasons lung screening isn't being used when compared to breast screening, such as smoking stigma and fear, along with a lack of awareness of lung screening. By conducting this trial, researchers want to assess the effectiveness of advocates and supporters of breast and lung screening, and to learn about the psychological barriers to cancer screening, identifying those that are unique to lung screening.

PRIMARY OBJECTIVES:

I. Determine the number of patients undergoing breast screening who are eligible to participate in lung screening.

II. Determine whether patients currently participating in cancer screening (breast OR lung) are successful as "cancer screening advocates." III. Determine whether laypersons who are aware of screening (including those who accompany friends and family members to their screening appointments) are successful as "cancer screening advocates." IV. Identify knowledge base and psychological barriers to screening through surveys of potential screening participants.

OUTLINE:

Participants access an electronic patient portal with educational materials at baseline, 1- and 2-year follow-ups, and also interact with a patient navigator on study. Patients also receive materials to share with their friends/family on benefits of breast and lung cancer screening on study.

After completion of study intervention, participants are followed up yearly for up to 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Age:

  * Breast screening \> 40
  * Lung screening 50-80
* Male (M) or Female (F)
* Current, former, or never smokers
* Close family or friend with smoking history (in or out of state)

Exclusion Criteria:

* Age:

  * Breast screening \< 40
  * Lung screening \< 50 or \> 80
* Persons who had previously received a diagnosis of lung cancer, had hemoptysis, or had an unexplained weight loss of more than 6.8 kg (15 lb) in the preceding year will also be excluded
* Persons with an active cancer
Postoperative Outcomes After Positive Intraoperative Messages

The patients scheduled for laparoscopic cholecystectomy will be allocated to 3 groups. Group A and B patients will listen to a positive message under general anesthesia. Group C patients will not listen to the message. The postoperative pain, analgesic consumption and frequency of nausea, vomiting and emergence agitation episodes will be documented and compared between the 3 groups.


Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic cholecystectomy.
* ASA 1-3

Exclusion Criteria:

* Hearing loss.
* Chronic use of drugs which affect the central nervous system (antidepressants, antiepileptics, opioids, benzodiazepines)
Asthma in the Elderly: The Role of Vitamin D

We will study whether taking vitamin D improves asthma control and spirometric values in elderly asthmatics.


Eligibility Criteria:
Inclusion Criteria:

* Asthma, age of 65 years old or older

Exclusion Criteria:

* Current smokers, subjects who smoked more than 10 pack/year, subjects taking digoxin, subjects with liver disease
Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery

FlexHD and Alloderm are two common products used in breast reconstruction to hold tissue expanders and implants in place. There have been few chart review studies comparing outcomes between the two materials in breast reconstruction. These studies have determined there is no difference in complication rates between the two materials. However, there have never been any active studies to date. This study will serve as a randomized controlled trial comparing FlexHD and Alloderm. Several outcomes will be measured based off of inclusion and exclusion criteria to determine if either product is more suitable for use in breast reconstruction. This will be performed by randomly assigning patients to receive either FlexHD or Alloderm. Designated outcomes will be followed closely postoperatively. Outcomes will be statistically analyzed to determine complication rates between FlexHD and Alloderm and thus which product is better to use in breast reconstruction.

FlexHD and Alloderm are two common products used in breast reconstruction to hold tissue expanders and implants in place. There have been few chart review studies comparing outcomes between the two materials in breast reconstruction. These studies have determined there is no difference in complication rates between the two materials. However, there have never been any active studies to date. This study will serve as a randomized controlled trial comparing FlexHD and Alloderm. Several outcomes will be measured based off of inclusion and exclusion criteria to determine if either product is more suitable for use in breast reconstruction. This will be performed by randomly assigning patients to receive either FlexHD or Alloderm. Designated outcomes will be followed closely postoperatively. Outcomes will be statistically analyzed to determine complication rates between FlexHD and Alloderm and thus which product is better to use in breast reconstruction

Eligibility Criteria:
Inclusion Criteria:

* BMI\<30
* No Prior Breast Radiation
* No Prior Breast Reduction
* No Diabetes Mellitus (IDDM and non-IDDM)
* Non-smoker or quit \>6 weeks prior
* No breast implants or prior breast implants
* No inflammatory or autoimmune disorders
* No current anticoagulation therapy
* No current pregnant

Exclusion Criteria:

* BMI \> 30
* Prior Breast Radiation
* Diabetes Mellitus - IDDM and non IDDM
* Prior Breast Reduction
* Active Smoker or Recently Quit \<6 weeks
* Prior Breast Implants
* Inflammatory/Autoimmune Condition (ex. Lupus)
* Current Anticoagulation Therapy
* Pregnancy
Extra-short vs. Non-extra-short Dental Implants Splinted on the Same Prosthesis

The main aim of this prospective study is to analyze the survival rate of short-length implants (\<6.5 mm) in subjects with partial edentulism. Non-short length implant will be used as control arm. Additionally, others clinical parameters (marginal bone loss and prosthetic associated complications) will be measured.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Have planned a fixed multiple prosthesis supported by implants \<6.5 mm in length and implants ≥ 6.5 mm in length within 15 days before the inclusion of the patient in the study.
* Planning of supported prostheses from 2 to 4 implants dental
* Have a previously performed CBCT (Cone Beam Computed Tomography)
* Availability to be observed during the period of tracing
* Signature of the informed consent

Exclusion Criteria:

* Smokers\> 10 cigarettes / day
* Complete prostheses
* Unitary prostheses
Has Inflammation a Significant Implication in Lung Cancer Evolution?

Systemic inflammation is a potential prognostic factor in cancer. Inflammation scores as the Glasgow score have been tested in cancer and specifically in lung cancer patients. The aim of the study is to look at the prognostic and predictive value of inflammation during cancer evolution, on the risk of complications leading to ICU admission and the risk of death.

Patients with newly diagnosed lung cancer will be eligible. All patients will have a blood sampling allowing testing inflammation and cytokine analyses at diagnosis, during work-up and in case of complication.

Eligibility Criteria:
Inclusion Criteria:

* Lung neoplasms irrespective of stage, histology

Exclusion Criteria:

* Previously treated lung neoplasms
* A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or cured malignant tumour (more than 5 year disease-free interval)
Effects of Kinesio Taping on Hip Abductor Muscle Strength and EMG Activity

Athletes with chronic ankle instability tend to develop Glutei muscle weakness. This weakness makes the lower limb prone to injuries. Kinesio Tape (KT) may assist this muscle in performing its functions thus preventing injuries.

The aim was to study the effects of Kinesio Tape on hip abductor muscle strength and EMG activity. Pretest-posttest experimental design was used. The study was conducted in the research lab of the University. Thirty-four athletes with a mean age of 22.08 years participated in the study. For the experimental group Kinesio Tape and for the control group Micropore Tape (MT) was applied over Gluteus Medius (GM) muscle. GM muscle's strength and EMG activity were noted in supine and during the Single-Leg Squat Test (SLST) respectively before and after the intervention. Hip abductor muscle strength measured through a maximum voluntary isometric contraction (MVIC) and GM activation measured through EMG. Handheld dynamometer (Lafayette manual muscle test system), Power Lab EMG system.

Eligibility Criteria:
Inclusion Criteria:

* Repeated episodes of giving way after an initial ankle sprain,
* A history of at least 2 ankle sprains to the same side without injury to the contralateral ankle in the last 2 years,
* No history of other trauma to the lower extremities for the past 3 months prior to the study,
* Participants also needed to be capable of full weight-bearing without analgia,
* Subjectively reported that functional use of ankle had plateaued since the last injury.

Exclusion Criteria:

* Participants having a history of ankle fracture, knee ligament injury, back or lower limb surgery, neuromuscular disease, or current neurological deficit,
* Currently receiving ankle rehabilitation were excluded from the study.
Retrospective, Non-interventional Natural History of Patients With Juvenile-onset Hypophosphatasia (HPP)

The purpose of this study is to characterize the natural history of HPP in patients with Juvenile-onset HPP.

Hypophosphatasia (HPP) is a life-threatening, genetic, and ultra-rare metabolic disease characterized by defective bone mineralization and impaired phosphate and calcium regulation that can lead to progressive damage to multiple vital organs, including destruction and deformity of bones, profound muscle weakness, seizures, impaired renal function, and respiratory failure. There are no approved disease-modifying treatments for patients with this disease. There is also limited data available on the natural course of this disease over time, particularly in patients with the juvenile-onset form.

Eligibility Criteria:
Inclusion Criteria:

* Documented informed consent unless patient is deceased
* Patients with Juvenile-onset HPP, defined as documented onset of first signs/symptoms at ≥ 6 months to ˂18 years
* Documented diagnosis of HPP as indicated by skeletal manifestations and low alkaline phosphatase or genotyping

Exclusion Criteria:

* Received treatment with asfotase alfa in the ENB-006-09 study and/or currently enrolled in the ENB-008-10 study
* Received other treatment and/or intervention to treat HPP up to 15 years old
* Other clinically significant disease