cyrilzakka/clinical-trials huggingface dataset:
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study

This study aims to confirm that the benefit-risk assessment of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) remains positive in real-world use and to ensure the adequacy of the TAMBE Device training program.

A maximum of 300 adult subjects will be enrolled at up to 60 U.S. centers, with a minimum of 70 subjects enrolled at study centers with no prior experience using the TAMBE Device. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 10 years post implant.

Eligibility Criteria:
Inclusion Criteria:

The subject is / has:

1. Treated with the aortic component of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Aortic Component) to allow endovascular repair of an aortic disease involving the visceral vessels.
2. Age ≥18 years at the time of informed consent signature.
3. An Informed Consent Form signed by subject or legal representative.

Exclusion Criteria:

The subject is / has:

1. Any contraindications for the TAMBE Device according to the IFU.
2. Planned parallel grafting with the TAMBE Aortic Component.
3. Intent to modify TAMBE Aortic Component (e.g., in situ fenestration).
Investigation of the Audible ICD Alert Tone

Ability of ICD patients to hear the audible ICD alert is being assessed.


Eligibility Criteria:
Inclusion Criteria:

* patient equipped with a subcutaneous ICD
* willing to participate

Exclusion Criteria:

* S-ICD implantation within the past 3 weeks
* patient is deaf
Off-site Training in Laparoscopy

The study is a randomized study exploring the difference between off-site vs. on-site training in laparoscopic skills. The study will be performed using fifty surgical trainees from the departments of urology, surgery and gynecology. The participants will be recruited, enrolled and randomized during the introductory course in basic laparoscopic techniques held six times annually at Center of Clinical Education(CEKU).

Participants will be able to train laparoscopic skills on a Box Trainer(BT) and on a Virtual Reality Simulator(VRS). They will practice until they reach a predefined level of proficiency on seven basic modules, the procedure module; "salpingectomy" on the LapSim™ and reach the passing level of 358pts on the Training and Assessment of Basic Laparoscopic Techniques(TABLT) technical test.

The intervention group will have a portable trainer available to allow training at their convenience, be it at home or at work. The control group will only practice on-site at CEKU and at their local hospital.

Participants will be asked to keep a training log with details of time spend on training and number of training sessions. The training log will contain information on any type practice involving laparoscopy be it on a BT or a VRS at the local hospital, at home on the tablet trainer or training at CEKU. Also time spend in the operation room, assisting or performing laparoscopic surgery will be registered.

To pass the TABLT all participants will book a test session at CEKU for their final test at the end of their training. At the test sessions TABLT test scores will be established on site by the Chief Investigator and afterwards using video recordings of the test. A blinded rater will give scores based on the video recordings and this will be the decisive rating to determine whether the participant has passed the test.

To pass the VRS training an employee at CEKU will monitor a VRS practice session in which proficiency level is reached.

The enrollment of participants is expected to finish June 2015 a data analysis will be performed in July 2015.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

* hey have performed more than 50 laparoscopic procedures.
Safety Study of Ciclopirox Olamine Cream for Dermatomycoses in Children

Ciclopirox olamine (Ciclochem®) is a pyridone broad spectrum antifungal drug which has shown activity on dermatophytes, yeasts, moulds, actinomycetes and some bacteria. Its mechanism of action is based on a fungicidal activity by inhibiting the cellular captation of essential substances needed for the metabolism and growth of the fungi. On the other hand, this drug binds irreversibly with cell structures as mitochondria, ribosomes, microsomes and cell wall. After dermal application, Ciclopirox olamine undergoes skin penetration, being only absorbed a 1,5% of the applied dose. Clinical efficacy has been studied in patients above 10 years with superficial dermatomycoses (dermatophytoses, candidiasis and pityriasis versicolor) and the percentage of clinical healing ranged from 77% to 91% after 2-4 weeks of twice a day topical application. In all the studies, the safety profile has been very good, showing only a very low rate of adverse events of mild to moderate intensity. There are very few previous available data on the application of this compound in children under 10 years of age. A single study had been performed with a solution formulation in patients from 6 to 29 months with diaper candidiasis, showing good efficacy and tolerability in these patients. The present study aims to show the safety and tolerability of ciclopirox olamine in a cream formulation in patients from 3 months to 10 years with dermatomycoses.

A multicenter, open, prospective, Phase IV study of Ciclopirox olamine on patients from 3 months to 10 years with all kinds of dermatomycoses. All body areas were treatable except scalp and nails (no tinea on the scalp nor onychomycoses) . Cream applied BID between 6.00 and 10.00am and 7.00 and 10.00pm daily for 4 weeks.Control visit after 4 more weeks without treatment was performed in order to evaluate the relapse rate.

Eligibility Criteria:
Inclusion Criteria:

* Patients from 3 months to 10 years of age.
* Patients diagnosed of dermatomycoses produced by yeasts or dermatophytes by KOH technique at the inclusion moment, which has to be confirmed by culture.
* Obtention of the informed consent of the parents or legal representatives of the patients

Exclusion Criteria:

* Previous treatment with oral or topical antifungal drugs.
* Hypersensitivity to ciclopirox olamine or some of the cream excipients.
* Use of topical or oral steroids concomitantly.
* Patients with mycoses on the scalp or nails.
A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Multiple Sclerosis and Their Infants

The purpose of this retrospective observational cohort study is to assess pregnancy and infant outcomes in three groups: the first is women with multiple sclerosis (MS) who were exposed to ozanimod during pregnancy; the second is women with MS exposed to select other disease-modifying therapies (DMTs) during pregnancy; the third is women with MS not exposed to any DMTs during pregnancy. This study will use data from a large US healthcare claims database.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 to 49 years at date of conception
* Date of conception between April 1, 2020 and July 31, 2030

Exclusion Criteria:

* Pregnancies exposed to any known teratogens and the exposure falls within the period of 5 half-lives prior to the estimated date of conception through the end of the first trimester (assessed via the presence of national drug codes or medical procedure codes)
* Exposure to the DMTs fingolimod, siponimod, mitoxantrone, and teriflunomide within a period of 5 half-lives prior to the estimated date of conception through the end of the first trimester
Neonatal Pulse Oximetry Disparities Due to Skin Pigmentation

The goal of this clinical trial is to determine if pulse oximeters show an SaO2-SpO2 discrepancy that correlates with skin pigmentation such that pulse oximetry will overestimate oxygenation in newborns with darker skin. The main questions it aims to answer is if SaO2-SpO2 discrepancy varies with the degree of skin pigmentation among neonates, if gestational age has an influence on SaO2-SpO2 discrepancy, and if packed red blood cell (PRBC) transfusion has an influence on SaO2-SpO2 discrepancy in newborns with various degrees of light and dark skin. Researchers will compare SaO2 and SpO2 values in neonates of various skin pigmentation.

Investigators will use a multicenter prospective cohort approach to measure SpO2 and SaO2 simultaneously in newborns of varying degrees of light and dark skin. The investigators will enroll 163 newborns of varying degrees of light and dark skin to assess the impact of skin pigmentation on the accuracy of pulse oximetry. Data collection will occur during routine blood samples and will involve simultaneous measurement of oxygen saturation by pulse oximetry and additional data extraction from the EHR. The study consists of 4 main components: (1) Skin pigment classification (2) Race and ethnicity classification (3) SpO2 measurement collection (4) EMR data collection (including newborn screen hemoglobin type assessment and transfusion records). After adjusting for SaO2, the SaO2-SpO2 discrepancy will correlate with skin pigmentation such that pulse oximetry will overestimate oxygenation in newborns with darker skin. The distribution of SaO2-SpO2 discrepancy will have more variance in the newborns with darker skin.

Eligibility Criteria:
Inclusion Criteria:

* Newborns postnatal age \< 10 days admitted to intensive care unit
* Presence of arterial catheter or undergoing arterial stick blood gas sampling

Exclusion Criteria:

* Presence of abnormal hemoglobin (including methemoglobin \> 3%) - likely to only be known after enrolled and the blood gas is obtained
* Those in whom SpO2 cannot be measured in the same extremity as the arterial catheter.
Ultrasound Guided Thoracic Paravertebral Block for Hepatic Tumors Ablation

Patients undergo percutaneous radiofrequency ablation of hepatic tumors at Siriraj hospital normally receive only intravenous sedative drugs which sometimes can not provide effective pain control.

TPVB is suitable for unilateral operations. And it is increasing popular nowadays because of using ultrasound guided which make it is more reliable and has less side effects especially the severe one such as pneumothorax. To cover all nerve supply liver, we decided to use right TPVB at T5-6, T7-8, and T9-10.

The aim of this study is to prove that TPVB can provide an effective pain control for patients undergo liver RFA both at rest and movement (cough). We are going to measure the pain score at recovery room and the effective pain control means patients has mild pain (pain score less \</= 3 and do not ask for analgesic drugs).


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patients undergo percutaneous radiofrequency ablation for liver tumors
* ASA classification 1-3

Exclusion Criteria:

* Psychiatric illness
* Chronic abdominal pain \> 1 week
* Regular analgesic drugs use
* Infection at back (Block area)
* Severe spinal deformity
* PT \> 16 sec, aPTT \> 32, platelet \< 50,000/cumm
A Pilot Feasibility Study of Activated Charcoal in Healthy Volunteers

This is a pilot study designed to test feasibility, tolerability, and safety of medical grade oral Activated Charcoal (AC) in 12 healthy volunteers. To determine the two most palatable and tolerable AC combinations. There will be a total of 4 combinations (2 AC doses and 2 solutions) in stage 1. Each participant will drink an assigned combination every day for 3 consecutive days (Monday, Tuesday, Wednesday, "M/T/W") and switch to a different assigned combination M/T/W the following week. AC solution assignments will be defined before the study using a balanced incomplete block design. Each subject will rate their experience using a 5-point scale every day for the 12 days they are on study.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* No use of prescription medications, including oral birth control, currently or in the last 30 days
* Sexually active women must be using an effective form of contraception. Note that subjects who are on oral contraception should use an additional form of contraception such as barrier methods, as AC may interfere with the efficacy of oral contraceptive
* Voluntary written consent signed before performance of any study-related procedure

Exclusion Criteria:

* At risk of GI hemorrhage or perforation due to underlying pathology, recent surgery, or medical conditions that could be adversely affected by the administration of AC
* Planning to have an endoscopic procedure
* Known hypersensitivity to AC
* Non-English speakers
Evaluate Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19 in China

A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2 in China

A multicentre, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of Azvudine versus placebo in preventing SARS-CoV-2 infection in household contacts with SARS-CoV-2 infection individuals.Approximately 300 adults with household contact exposure to individuals with a confirmed SARS-CoV-2 infection will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

1、18-65 years old at the signing of informed consent. 2、Household contacts of individual with symptomatic COVID-19. Symptomatic COVID-19 cases (index case) to be identified as those symptomatic and recently tested (rapid antigen test or RT-PCR) positive for SARS-CoV-2 and must fulfill the following criteria 1) collection of the first positive SARS-CoV-2 test sample less than 24 hours before randomization, 2) have at least one symptom attributable to COVID-19.

3、RT-PCR test negative (with nasopharyngeal \[NP\] swab samples) OR rapid antigen test negative at the time of screening and without any suspicious COVID-19 symptoms within 2 weeks before randomization.

4、Subject expects to be living in the same household with the symptomatic COVID-19 cases during the whole study period.

Exclusion Criteria:

1. Subject with a history of SARS-CoV-2 vaccinations within 1 months before randomization.
2. Subject with a history of SARS-CoV-2 infection within 6 months before randomization.
3. With any serious infection requiring systemic anti-infective therapy within 14 days before randomization.
4. Allergic to the investigational agent or any components of the formulation. Pregnant or breast-feeding women.
5. Women of childbearing potential who are unwilling to practice highly effective contraception during the study, and for at least 6 months after the study; Sexually active men who are unwilling to use medically acceptable birth control during the study period.
6. Have other conditions not suitable for inclusion as judged by the investigator.
Evaluation of Manhood 2.0: A Community-Based Teen Pregnancy Prevention Program for Young Men

Manhood 2.0 is a male-only group-level intervention, delivered over 13 hours, based on social cognitive theory, social norm theory, theory of gender and power, and the theory of reasoned action. The intervention is a gender-transformative program that promotes critical reflection and awareness on reproductive health, healthy relationships, gender norms and stereotypes that drive reproductive health behavior, and explicit and proactive support of female partner contraceptive use. Activities include group discussion, role playing, knowledge sharing, and skill-building; their purpose is to challenge young men to think critically about social expectations and restrictive norms, engage in dialogue about these gender norms, and then assess the way rigid norms affect their attitudes and behaviors toward a number of key issues, including intimate relationships, gender-based violence, substance abuse, sexually transmitted infections, and early pregnancy. Young men receive the intervention at a local community center or high school. Comparison condition young men receive a post-high school readiness program that does not discuss gender norms or sexual and reproductive health. The study was conducted with six cohorts of eligible young men ages 15-18 who received a baseline, immediate post-intervention, and three-month post-intervention survey. To participate in the study, individuals had to meet all the following criteria: (1) Identify as male; (2) Ages 15 to 18; (3) Not actively planning a pregnancy with someone; (4) Never participated in the community center's sexual and reproductive health program; (5) Received no additional sexual or reproductive health programming in the last three months; (6) Able to participate in a program delivered in English only.

The investigators hypothesized that Manhood 2.0 participants would have lower rates of unprotected sex and more equitable attitudes towards gender than comparison participants.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Ages 15-18
* Able to participate in a program delivered only in English

Exclusion Criteria:

* Actively planning a pregnancy with someone
* Received sexual and reproductive health programming in the last 3 months
* Ever participated in the intervention site's sexual and reproductive health program
Antiplatelet Therapy in Chronic Urticaria

This study compares the combination of antiplatelets and antihistamine versus antihistamine alone for the treatment of chronic spontaneous urticaria

This study is a randomized control trial comparing the effectiveness of the combination of antiplatelets and antihistamine and antihistamine alone for the treatment of chronic spontaneous urticaria

Eligibility Criteria:
Inclusion Criteria:

Chronic spontaneous urticaria

D-dimer levels over 500 ng/ml

Not respond to a conventional dose of antihistamine

Exclusion Criteria:

Are taking aspirin

Have bleeding tendency

Have concurrent severe medical illnesses

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Preventive Physiotherapy Intervention in Elderly People With Sarcopenia

This study evaluates two strength training protocols (one in peripheral muscles and one in inspiratory muscles) in the improvement of skeletal muscle mass and function in institutionalized elderly with sarcopenia. Participants will be assigned randomly in a control or one of both experimental groups.

Sarcopenia is a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength with a risk of adverse outcomes such as physical disability, poor quality of life and death (Goodpaster et al, 2006; Delmonico et al, 2007). The contributing factors are those related to aging process, non-optimal diet, bed rest or sedentary lifestyle, chronic diseases and certain drug treatments. Most of these factors are present in the older population with comorbidity, frequently institutionalized to receive a professional long-term care.

Since the European Working Group on Sarcopenia in Older People (Cruz-Jentoft et al, 2010) recommends using the presence of both low muscle mass and low muscle function (strength and/or physical performance) for the diagnosis of sarcopenia, interventions should be focused in both criteria. The aim of this study is to prevent loss of skeletal muscle mass and strength in institutionalized elderly with sarcopenia.

To this purpose, the investigators study undertakes two physiotherapy interventions to preventing/treating Sarcopenia, namely, maintenance of muscle mass and improvement of strength in peripheral and respiratory muscles. Both interventions are common in the following features: supervision, duration, frequency and intensity of the training program.

The primary outcomes are those related to muscle mass and strength. Secondary outcomes will be related to muscle function (muscle endurance and/or physical performance), costs and health status (number of falls and fractures, exacerbations of chronic diseases, hospitalizations and deaths during the year after concluding the physiotherapy interventions).

Eligibility Criteria:
Inclusion Criteria:

* People aged \> 65 years
* Sarcopenia diagnosis (Tyrovolas et al., 2015)
* Medically stable at least 2 months before the study

Exclusion Criteria:

* Cardiorespiratory, muscular, neurological, or neuromuscular disease that could interfere in the proper performance of assessment and/or training protocols.
* Endocrine and metabolic disorders that might have had an effect on muscle mass.
* Severe disorder of hydration status that could interfere in Bioelectrical Impedance Analysis (Rubbieri et al., 2014).
* A terminal disease diagnosis.
* Mini-Mental State Examination Index ≤ 20 score.
Decision to Limit or Withdraw Specific Therapies for Advanced Cancer and Hematological Malignancies.

The decision to limit or withdraw specific therapies (DLWT) in patients with advanced cancer is a complex process that is always painful for patients, relatives and professionals. For more than 10 years, shared decision making has been more and more emphasized. However, few data in the literature rely on clinical research. In order to understand their difficulties and issues, this study explores the determinants and modalities of DLWT and analyses the feasibility of different methods for investigating this decision making process.

This study explores the decision-making process for patients with advanced cancer when the question to imit or withdraw specific therapies (DLWT) is raised, with a cross-analysis of physicians and pts points of view.

This study took place in 5 oncology and hematology units : 2 university hospitals, 1 general hospital, 1 cancer center and 1 private hospital. The study included two different approaches: an epidemiological section to identify the prevalence of these situations in different institutions and a qualitative study section exploring factors influencing the decision process. The epidemiological analysis included all hospitalized patients identified with advanced cancer for whom the question of DLWT was raised in a given week or during the two weeks preceding the investigation.

The qualitative analysis was based on interviews with the referent oncologist (or hematologist) and his patient (conducted by a physician and a psychologist respectively) as well as interviews with other partners involved in the situation (care staff and relatives) depending on the center. Researchers also participated in multidisciplinary meetings and monitored changes in the decision over a three month period.

Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced cancer
* Existence of a questioning about DLWT
* Absence of guide lines

Exclusion Criteria:

* Incapacity of the patient to participate to an interview
* Absence of informed consent
Comparative Efficacy of 10% Potassium Hydroxide Solution Versus Cryotherapy in Molluscum Contagiosum

A total of sixty patients presented to the outpatient dermatology department of Combined military hospital (CMH) Abbottabad with signs of molluscum contagiosum clinically diagnosed meeting inclusion criteria were enrolled. Sample size was calculated using WHO sample size calculator. They were divided into two groups i.e Group A and Group B using lottery method. Patients in Group A were subjected to cryotherapy (liquid nitrogen gas) whereas patients in Group B patients were subjected to 10% potassium hydroxide solution for 3 weeks and were followed up at 2nd, 4th, 8th and 12th week for observing the progress of therapy in both groups on each follow up visit and ascertaining the efficacy respectively.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of molluscum contagiosum having 3-20 lesion
* no history of treatment before
* willingness to participate (given by parents)

Exclusion Criteria:

* Patients with facial lesions
* known immunodeficiency
* tendency for hypertrophic scarring
* known hypersensitivity