cyrilzakka/clinical-trials huggingface dataset:
Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AHT956 in Healthy Subjects

This study will evaluate the safety and tolerability of ascending single oral doses of AHT956 in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects age 18 to 45 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
* Vital signs must be within the following ranges: oral body temperature between 35.0-37.5 °C; systolic blood pressure, 90-145 mm Hg; diastolic blood pressure, 50-95 mm Hg; pulse rate, 40-90 bpm
* Female subjects must either:have been surgically sterilized or hysterectomized at last 6 months prior to study participation with clinical documentation be postmenopausal (no regular menstrual bleeding for at least 1 year prior to study start)
* Body mass index must be within the range of 18 to 28 kg/m². Subjects must weigh at least 50 kg to participate in this study.

Exclusion Criteria:

* Smokers (any subject who uses tobacco or has cotinine greater than 500 ng/mL)).
* Subjects who received live vaccine 4 weeks prior to dosing, any prescription drug use with 4 weeks prior to dosing, or over-the-counter medication use within 2 weeks prior to dosing.
* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
* Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
* Flu-like symptoms or significant within two weeks prior to dosing.
* A past medical history of clinically significant abnormality detected during electrocardiogram (ECG) examination or an evident family history (grandparents, parents and siblings) of a ECG abnormality (i.e. prolonged QT-interval syndrome).
* History of fainting, hypotension when standing up, arrhythmia.
* History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
* History of clinically significant drug allergy or history of atopic allergy, urticaria, eczematous dermatitis). A known hypersensitivity to the study drugs or drugs similar to the study drugs.
* Any history of surgical or medical condition(s) which could change the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject, including history of gastrointestinal, pancreatic, liver, kidney, bladder, blood, or immune systems.
* History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted the screening or baseline evaluations.

Other protocol-defined inclusion/exclusion criteria may apply
Robot-assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy

This is the first randomized controlled study to compare the robot-assisted esophagectomy (RAE) to minimally invasive conventional thoracoscopic esophagectomy (CTE). The aim of this trial is to evaluate the safety, risks of the robot-assisted esophagectomy, and to compare the short-term operative outcomes and long-term oncological outcomes between the two surgical treatments.

Objective: This study aims to compare the oncological outcomes between robot-assisted esophagectomy and minimally invasive conventional thoracoscopic esophagectomy.

Study design: Randomized controlled parallel-group superiority trial Study population: Patients (age \>= 18 and \<= 75 years) with histologically proven surgically resectable (cT1b-3, N0-2, M0) squamous cell carcinoma of the intrathoracic esophagus with European Clinical Oncology Group performance status 0, 1 or 2.

Intervention: 360 patients will be randomly allocated to either A) robot-assisted esophagectomy (n=180) or B) conventional thoracoscopic esophagectomy (n=180).

Patients will receive the following interventions:

Group A. robot assisted esophagectomy, with gastric conduit formation. Group B. conventional thoracoscopic esophagectomy, with gastric conduit formation.

Main study parameters/endpoints: Primary outcome is 5-year overall survival rate.

Secondary outcomes are 5-year disease free survival, 3-year overall survival rate, 3-year disease free survival, (in hospital) mortality within 30 and 60 days, R0 resections, operation related events, postoperative recovery, lymph nodes status, quality of life.

Follow-up: 60 months after discharge of the last randomized patient.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven squamous cell carcinoma of the intrathoracic esophagus.
* Surgical resectable (T1b-3, N0-2, M0)
* Age ≥ 18 and ≤ 75 years
* European Clinical Oncology Group performance status 0, 1 or 2
* Written informed consent

Exclusion Criteria:

* Carcinoma of the cervical esophagus
* Histologically proven adenocarcinoma or undifferentiated carcinoma.
* Prior thoracic surgery at the right hemithorax or thorax trauma.
* Infectious disease with systemic therapy indicated.
University of North Carolina-Healthwise Partnership Project on Birth Options Decision Aid

This is pilot quasi-experimental study of women with one or two prior cesarean deliveries who are now pregnant and eligible for a trial of labor after cesarean delivery, to assess whether a decision aid, providing knowledge about trial of labor (VBAC) and planned repeat cesarean delivery can improve the birth options decision-making process for patients.

Participants are screened for eligibility through electronic health records. Once an individual is screened eligible, and email invite is sent providing information about the study and assessing the interest in participation. An on-line consent is completed and women are entered sequentially into the usual care group and then through further recruitment, another sample of women are entered into the decision aid group. The primary outcome is satisfaction with the shared decision-making process with their provider.

Once a potential participant is screened eligible, completes the on-line informed consent, they are officially enrolled in the study and sent a link confirming their enrollment and the study group in which they have been assigned. Participants are sequentially enrolled in the study with enrollment first into the usual care group. Once enrollment in the usual care group is complete, enrollment into the decision aid group will occur.

The study includes two non-randomized groups:

Arm 1 (Usual care group): Women in this group will undergo usual care and complete the survey questions on knowledge of risks and benefits of TOLAC (also referred to as VBAC) and planned repeat cesarean (PRCS), certainty of their decision, and involvement in the decision for trial of labor (TOLAC) or repeat cesarean delivery.

Arm 2: (Decision aid group- group receiving the decision tool): Women in this group will receive a decision aid prior to undergoing counseling by their physician. Following completion of the decision aid and physician counseling, they will complete a series of survey questions to assess their knowledge of the risks and benefits of TOLAC and PRCS, certainty of their decision, and involvement in the decision for repeat cesarean or TOLAC.

The decision aid group will be compared with women who do not receive the decision aid (usual care group).

Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 19/0 and 36/6 weeks
* History of 1 or 2 prior cesarean deliveries

Exclusion Criteria:

* No contraindications to trial of labor after cesarean (TOLAC)
* No history of prior TOLAC
Web-based Education for Diabetes Patients on Adaptable Insulin Schedules

Inclusion criteria: adult diabetes patients on multiple daily insulin injections or using an insulin pump; Internet users Exclusion criteria: having a severe mental illness Patients will be recruited during the conventional consult. If they want to participate, they will get detailed information regarding the study; after giving consent; they will sign the informed consent form and they will get a unique study number.

The patient will than complete a questionnaire on a secured website (https://) using the unique study number. After completing this questionnaire, the patient will be randomised either into a group 'standard care + direct start with web-based diabetes education' (intervention group) or they will enter into the other group (control) receiving standard care. Three months after the start of the study, all patients will be asked to complete the questionnaire again and the patients into the control group will also get access to 'standard care + web-based diabetes education'. The questionnaire will have to be completed on months 6, year 1 and year 2. At the time of completing the questionnaire, HbA1c will be determined. This is part of the routine examination in each participating hospital (UZGent and AZ Nikolaas). The determination of HbA1c is not study-specific but the value will be taken into the study.

The web-based questionnaire:

Patients will enter on a website including general study-information. They also have to explicitly click a button to proceed to the questionnaire. After clicking on 'I am prepared to participate in the study' they will see a second webpage retrieving some general information. After receiving this real basic information; they will be redirected to a secure website (https://) and will make use of a unique study number. Only the main researcher will have the possibility to link the general information to the unique study number.

The informed consent form:

The patient will be asked for added information. He/she will have to sign specific pages giving explicitly informed consent for information retrieved from the 'mutualiteit' (National Health Service - NHS).

On the NHS information will be asked regarding the health costs. These figures should make it possible to have a more objective figure of the costs associated to diabetes (care).

The patient can stop on every moment the study participation. Once decided he/she wants to stop, he/she will receive standard care.

Study hypotheses: the QoL will improve by the use of web-based diabetes education; there will be a reduction in costs using web-based diabetes education; there will be at least an equal-stay or improvement of the HbA1c while using web-based diabetes education.


Eligibility Criteria:
Inclusion Criteria:

* adult diabetes patients on multiple daily insulin injections or using an insulin pump;
* Internet users

Exclusion Criteria:

* having a severe mental illness
Health Beliefs, Behaviors, and Healthcare Experiences Among United States Young and Mid-Age Adults

The study will provide important insight into current HPV vaccine knowledge/awareness, health beliefs, affect, vaccine discussions, decision preparedness, and vaccine intentions and behaviors among those ages 18-45, while examining potential differences in responses between those ages 18-26 and those ages 27-45 and vaccinated and unvaccinated individuals.

The study will provide important insight into current HPV vaccine knowledge/awareness, health beliefs, affect, vaccine discussions, decision preparedness, and vaccine intentions and behaviors among those ages 18-45, while examining potential differences in responses between those ages 18-26 and those ages 27-45 and vaccinated and unvaccinated individuals. In addition, the study will illuminate gaps in knowledge and awareness as well as the education intervention preferences (e.g., intervention platform, source of information, timing of intervention) of individuals ages 18-45. Among those ages 27-45, shared clinical decision-making is recommended. Compared to individuals ages 18-26, individuals ages 27-45 may need to be supported uniquely so that they are prepared to engage in shared clinical decision-making about HPV vaccination with their healthcare provider. Thus, among unvaccinated individuals ages 27-45, for whom shared clinical decision-making is recommended, preparedness for engagement in shared clinical decision-making will be assessed and explored. The study also will allow investigators to identify how best to target information to young adults and mid-adults both for themselves, and among those with children, for their children.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-45
* Living in the United States
* a KnowledgePanel panelist directly or via verified partners
* Have internet access
* Able to read, write and understand English
* Individuals can participant regardless of their HPV vaccination status

Exclusion Criteria:

* Individuals who do not meet inclusion criteria
Laser Enucleation of Prostate (LEP) Versus Transurethral Resection of Prostate (TURP)

Benign prostatic hyperplasia (BPH) refers to the proliferation of smooth muscle and epithelial cells of the prostate gland. The enlarged gland has the potential to result in lower urinary tract symptoms (LUTS) secondary to either bladder outlet obstruction or increased muscle tone and resistance, or both.

For decades transurethral resection of the prostate (TURP) has been the gold standard for treatment of symptomatic BPH that is refractory to nonoperative management. This is a surgical intervention aimed to reduce the size of the prostate gland. However, over the past fifteen years, many alternative therapies have been introduced including laser enucleation of the prostate (LEP). LEP has numerous advantages including decreased blood loss and length of hospital stay as well as increased effectiveness and safety for large prostate gland sizes (\>80g).

The purpose of this study is to compare the effectiveness of TURP to LEP using the ProTouch laser technology. While TURP has historically been the gold standard, LEP has become more widespread and is arguably a safer and more effective therapy for the patient. TURP is still widely performed because it is a traditional therapy with decades of data to support its efficacy, despite higher volume of blood loss and risk for TUR syndrome. In comparison, there is some data demonstrating that Holmium Laser Enucleation of the Prostate can have similar efficacy but may have longer operative times. The ProTouch laser is comparable to the Holmium laser but additionally provides improved hemostasis and tissue vaporization. There is little to no data comparing LEP with the ProTouch laser to TURP. This study will directly compare the efficacy of these two treatment methods by enrolling eligible subjects and comparing outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Age \> 50-80 years
* Prostate gland size 50-100g
* Failure of nonoperative therapy
* IPSS 8+
* FR \<15ml/s
* PVR \<250
* If PVR is 250-400 then pre-operative urodynamics will be indicated
* Language: English, Spanish, Haitian Creole, French, Portuguese
* Willing to randomize

Exclusion Criteria:

* Neurogenic bladder
* PVR \>400ml
* IPSS \<8
* FR \>15ml/Indwelling catheter

  - History of prostate cancer
* History of urethral stricture or vesicourethral anastomotic stricture
* Unable to be placed in lithotomy position
* Unable to undergo general or spinal anesthesia
* Unable to consent
* Untreated or uncorrected coagulopathy
Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia

Children undergoing general anesthesia for surgery commonly need sedative and anxiolytic premedication but little clinical evidence supports is benefit for children older than 7 years old.

The aim of this prospective randomized clinical trial is to assess the impact of pharmacologic premedication on perioperative children experience.

Surgery is a stressful experience in children with preoperative and postoperative anxiety.

For preschooler undergoing surgery, anxiety is the highest in the preoperative period.

Most of studies have been conducted on young children (\< 7yrs old) to show the relationship between preoperative anxiety and emergence of delirium and postoperative maladaptive behavioral changes.

Sedative and anxiolytic medication is frequently used in children to reduce anxiety and postoperative maladaptive experiences. Nevertheless, little clinical evidence supports is benefit for children older than 7 years.

Treating anxiety is not necessarily associated with better experience in all children because premedication causes postoperative sedation, amnesia and cognitive impairment.

The aim of this prospective randomized clinical trial is to assess the impact of pharmacologic premedication on perioperative children experience using self-report questionnaire.

Patients are randomized to 2 groups to received pharmacologic premedication or placebo.

For the premedication group, children are randomly allocated to be premedicated with either with the midazolam or dexmedetomidine

Eligibility Criteria:
Inclusion Criteria:

* Subject over 7 and under 18 years of age
* Subjects who are scheduled for surgery
* Subject who will be under general anesthesia
* Subject able to complete a self-questionnaire in French

Exclusion Criteria:

* Subject who has already participated in the pediaPREM study
* Subject with a treated anxiety disorder
* Subject with cognitive disorders
* Subject suffering from chronic pain (outside the operated area)
* Subject with ADD (Attention Deficit Disorder) with or without hyperactivity, with or without treatment
* Subject suffering from mental retardation
* Subjects receiving psychotropic treatment
* Subject whose intervention could reduce the ability to complete a self-questionnaire (neurosurgery etc.)
* Subject with a contra-indication to midazolam and its excipients
* Subject with a contra-indication to dexmedetomidine and its excipients
* Subjects who need to receive intravenous alpha agonist in perioperative
* Subjects requiring emergency intervention
* Subjects requiring preoperative hypnosis
* Subject who needs general anesthesia for diagnostic purposes (biopsy, etc...)
* Subject having had a surgical intervention in the month preceding the inclusion.
* Subject who will have an iterative surgical intervention within 15 days (removal of material, burns etc...)
* Subjects who are scheduled for surgery as part of oncology management
* Pregnant or breastfeeding woman
* Subject whose two parents have not signed a written informed consent
* Subjects who are not affiliated with or benefiting from a social security plan
Outcomes of the Intradural Extramedullary Tumors Resection

The intradural extramedullary tumors remain curable diseases. Our aim in this study is to evaluate the postoperative status after the tumor resection and compare it to the preoperative status

Meticulous microscopic excision without nerve root or dural injuries

Eligibility Criteria:
Inclusion Criteria:

* neurological deficit
* back pain

Exclusion Criteria:

* old age above 80 years
* immunocompromised patients
Smoking Cessation Intervention in Public Housing

The major aim of this study is to test the effectiveness of a bundled, multi-level intervention (Sister to Sister) on smoking cessation outcomes in female smokers residing in public housing neighborhoods.

Hypothesis 1.1: As compared to the control group, women receiving the Sister to Sister Intervention will have higher 7-day point prevalence quit rates at 6- and 12-months as validated by salivary cotinine.

Hypothesis 1.2: As compared to the control group, women receiving the Sister to Sister Intervention will have higher 6- and 12-month prolonged smoking abstinence as validated by salivary cotinine.

This was a cluster randomized controlled study evaluating the effect of a multi-level intervention, Sister to Sister, on the smoking cessation in two Southeastern US metropolitan areas. Fourteen subsidized housing neighborhoods, eight in Charleston, SC and six in Augusta, GA, were pair matched based on size; with one neighborhood in each pair randomized to the intervention to ensure balanced recruitment between groups. Neighborhoods ranged in size from 22 to 33 participants with a total sample size of 409 women; neighborhoods were chosen as the primary sampling unit to prevent contamination of the outcome within neighborhoods, with women in the neighborhoods as secondary sampling unit. All statistical analyses were conducted using SAS 9.2 (SAS Institute, Cary, NC) with statistical significance at an alpha level of 0.05. Comparison between groups at baseline used t-tests for continuous variables and chi-square tests for categorical variables. The primary outcome of interest was smoking status which was dichotomized (smoker/non-smoker) at the 6 and 12 month measurements. Smoking status was determined by cotinine levels in saliva with non-smokers defined as those with cotinine levels of 14 ng/mL or less.

Eligibility Criteria:
Inclusion Criteria:

* 18 yrs of age and older,
* female, resident of public housing, daily smoker

Exclusion Criteria:

* pregnant,
* breastfeeding,
* no intentions to quit smoking
Observational Study of the Argus® II Retinal Prosthesis System

The Argus II Retinal Implant is a revolutionary new device, which offers vision to patients who are blind from retinal degeneration - retinitis pigmentosa. These patients have no alternatives. Patients typically can achieve ambulatory vision.

This study is an investigator-sponsored, observational, controlled, prospective, single-center study. The purpose of this current study is how it affects people's visual function and activities of daily living and to collect additional data on Argus II users in order to monitor the System's safety. In addition, data about the long-term reliability of the System will be gathered.

The Argus II retinal implant will be surgical implanted into patients who are blind but the surgical procedure is not a part of this observational study. Our hypothesis is that the visual results in our hands will be comparable to those reported in the FDA study. We will use the results of this study to plan future enhancements to the service and to explore the use of the device for other blinding conditions.

Eligibility Criteria:
Inclusion Criteria:

•Adults, age 25 years or older with severe to profound outer retinal degeneration.

but some residual light perception. If no residual light perception remains, the retina must be able to respond to electrical stimulation and previous history of useful form vision.

Exclusion Criteria:

* Ocular diseases or conditions that could prevent the Argus II System from working (e.g. optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, severe strabismus).
* Ocular structures or conditions that could prevent the successful implantation of the Argus II Implant or adequate healing from surgery (e.g. extremely thin conjunctiva, axial length \<20.5 mm or \> 26 mm, corneal ulcers, choroidal neovascularisation in the area of the intended tack location, etc.).
* Ocular diseases or conditions (other than cataracts) that prevent adequate visualisation of the inner structures of the eye (e.g. corneal opacity, etc.).
* Inability to tolerate general anaesthesia or the recommended antibiotic and steroid regimen associated with the implantation surgery.
* Predisposition to eye rubbing.