cyrilzakka/clinical-trials huggingface dataset:
Bedside Tests of Cardiorespiratory Fitness

A study of 64 older adults over the age of 65y to assess the utility of patient characteristics and bedside measures of physical function and muscle size to predict cardiorespiratory fitness.

A study of 64 older adults over the age of 65y to assess the utility of patient characteristics (age, gender and BMI) and bedside measures of physical function (handgrip strength and step box test) and muscle size (muscle thickness via B-mode ultrasonography (US)) to predict cardiorespiratory fitness (VO2peak and anaerobic threshold) as measured by the gold-standard assessment method, cardiopulmonary exercise testing (CPET).

Each participant will take part in a single assessment day (after health screening against CPET safety criteria) whereby they will have US measures of the vastus lateralis before completing HGS and step box test assessments, and finally a CPET.

Eligibility Criteria:
Inclusion Criteria:

* Over 65y
* Independent, community-dwelling

Exclusion Criteria:

* Contraindications to CPET safety criteria
Clinical Evaluation of the APTIMA® Assay for Chlamydia Trachomatis Using the PANTHER™ System

The objective of this multi-center clinical study is to demonstrate that the APTIMA(R) Assay for Chlamydia trachomatis (CT; "ACT Assay"), which is cleared for use on the TIGRIS DTS (Direct Transfer) System ("TIGRIS System"), can be tested on the PANTHER System. The intended use of the ACT Assay will be unchanged except for the inclusion of its use with the PANTHER System. ACT Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.

This protocol was withdrawn from clinical trials.gov because samples collected under this protocol were not tested per protocol using the Gen-Probe APTIMA(R) CT (Chlamydia trachomatis) Assay. Instead, testing was conducted and results were generated with the Gen-Probe APTIMA(R) Combo 2 Assay (for Chlamydia trachomatis and Neisseria gonorrhoeae). See Protocol Identification AC2PS-US11-001 (NCT01733069) for results. This action was recommended by the RRS team per their email to me on 8 February 2013.

Eligibility Criteria:
Inclusion Criteria:

* The subject is at least 14 years of age at the time of informed consent and is sexually active

  * The subject reports symptoms consistent with a suspected STD such as abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort.
  * If the subject is asymptomatic, the subject is known to be partners with, or a contact of, a person with a confirmed or suspected STD(s), is undergoing screening evaluation for a possible STD(s), and/or is scheduled for a routine exam that may include a pelvic exam
  * The subject and/or legally authorized representative is willing to undergo the informed consent process prior to study participation (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an IRBapproved waiver for parental consent for minors)

Exclusion Criteria:

* A potential subject will be ineligible for clinical trial enrollment if the subject, clinician, or medical record reports any of the following:

  * The subject took antibiotic medications within the last 21 days
  * The subject is underage (as defined by the IRB or state law), without the documented consent of her/his parent or legal guardian (exception: sites that have an IRBapproved waiver for parental consent for minors)
  * The subject is determined by the investigator to be medically unsuitable for participation in this study (eg, medical history of concurrent illness that could result in an unacceptable risk to the subject) Concurrent participation in other clinical study(ies) may be acceptable, with approval by the investigator and sponsor.
Handheld Computers to Improve Adherence to Anti-HIV Drug Regimens

While anti-HIV drugs can significantly reduce viral loads, the medication regimens can be complex, and patients must take them correctly for the best effect. Nonadherent patients risk developing drug resistant HIV strains. The purpose of this study is to evaluate the effectiveness of a handheld computerized system designed to help patients take their drugs correctly.

As the use of protease inhibitors and other antiretroviral medications has increased, multiple drug resistant HIV strains have emerged, demonstrating the need for improved patient adherence to complex drug regimens. Individual computerized adherence systems have been proposed as a mechanism for improving patient adherence. This study will utilize advanced computer and communication technologies to produce a handheld (PDA) product for HIV/AIDS patients. The system serves as a patient reminder system, addresses problems of missed medications, and monitors severity of side effects. This study will evaluate the efficacy of the system as an adherence intervention.

Participants in the study will be randomized to either the intervention or a control group. Participants will use the PDA daily for medication reminders, alarms, adherence tracking, and as a source of information on HIV/AIDS. The study will last 15 weeks. Each participant will have 6 study interviews and 2 quality control interviews. Study interviews will include adherence questionnaires, blood tests for viral load and CD4 data, and quality of life assessments.

Eligibility Criteria:
Inclusion Criteria

* HIV positive
* Currently taking medications for HIV/AIDS.
Real World Data on Management of Male LUTS

This study will describe the current medical care given to men who discuss their lower urinary tract symptoms with a HCP. It will document the primary reasons for the visit, the baseline characteristics of these men, the treatment received, and the practice patterns of specifically a primary care physician managing these patients.


Eligibility Criteria:
Inclusion criteria:

* Males, aged ≥18 years old.
* Having had discussion of urinary symptoms with their PCP between 15 days and 12 months prior to the date of the phone interview.
* Able to read, speak and understand English.
* Willing to provide informed consent for study participation, authorize the release of their previous 12-month medical records from their PCP for review and de-identified data entry by Mapi into an electronic study database.

Exclusion criteria:

* Reported during screening that they had had their first-ever discussion of urinary symptoms with PCP within the 14 days prior to the date of the phone interview.
* Participation in a clinical research study that evaluated urinary symptoms in the past 12 months.
* Self-reported history of colorectal, bladder or prostate cancer.
* Self-reported neurologic disorders that affect bladder function, e.g., neurogenic bladder disorders due to spinal cord injury/disease, multiple sclerosis, Parkinsons disease.
* Self-reported history of radiation therapy to the lower abdominal and/or pelvic region.
Application of a Positive Psychology Program for the Development of Emotional Skills in Prison

Studies show that emotional competence plays a significant role in psychological and physical health, and that programs aimed at their development are effective. Can a positive psychology program aimed at the development of emotional competence be implemented as part of care in lieu of deprivation of liberty? The investigators hypothesize the interest and possibility of implementing an emotional skills development program in the specific context of custodial care.

The main expected outcome of this study is the identification of necessary adaptations of the emotional skills development program of Kotsou, I. et al (2011) for its implementation in remand homes.

The expected secondary outcome is the identification of the interest of emotional skills development program (in prison) regarding :

* Therapeutic support for patients meeting the criteria for borderline personality disorder
* Participant satisfaction
* The development of emotional skills

Eligibility Criteria:
Inclusion criteria:

* Meet the criteria for borderline personality disorder (DSM-V),
* Interest in the issue of emotional skills development,
* Comprehension and use of the French language adapted to the study,
* Disposition to group practice,
* Attentive disposition allowing to participate in a therapeutic activity for 3 hours.
* Psychological/psychiatrical follow-up at the Health Unit of the Villeneuve-lès-Maguelone prison

Exclusion criteria:

* Minor patients
* Releasable before July 2021,
* Decompensated psychiatric disorders,
* Patient in withdrawal syndrome.
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH-006 in Healthy Volunteers

Huahui Health is developing a treatment for Hepatitis B virus. This study is designed to evaluate the safety and tolerability of HH-006, a hepatitis virus neutralizing monoclonal antibody in healthy volunteers, and to determine its pharmacokinetic profile and immunogenicity.

This is a double-blind, placebo-controlled, Phase Ia study aimed to evaluate the safety and tolerability of HH-006 after single ascending doses given as subcutaneous injections.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy male or female individuals aged between 18 to 65 years old
* A bodyweight ≥ 45 kg and the body mass index (BMI) is between 18 to 32 kg/m2.

Exclusion Criteria:

* History of anaphylaxis or other significant allergy in the opinion of the Investigator or known allergy or hypersensitivity to any of the components of the IP
* History of drug, alcohol, or substance abuse
* Any history of liver disease or known hepatic, or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
* Any history of anaphylaxis, severe allergic reaction, neutralizing antibody generations, or hypersensitivity to albumin or any protein-based therapeutics such as natalizumab (Tysabri) or any other monoclonal antibodies
* Any previous exposure to chimeric, humanized, or human monoclonal antibody, whether licensed or not
* Medical history of active infection (acute or chronic)
* Any safety concern or personal condition that is inappropriate for the study participation per the Investigator's judgement.
Real Time Microscopic Imaging During Robot Assisted Prostate Cancer Surgery

The study involves use of a device called an endomicroscope to obtain high resolution images of microscopic structures during robot-assisted prostate cancer surgery. This feasibility study is largely descriptive, and will use endomicroscopy to document the cellular and architectural appearance of tissue during minimally invasive prostate surgery for later comparison with features seen upon conventional histopathological examination of biopsies or resection specimens.

Prostate surgery requires meticulous dissection around nerves and associated structures such as the bladder, seminal vesicles and vas deferens. Nerve damage during prostatectomy can result in undesirable outcomes such as impotence and urinary incontinence. Robot assisted minimally invasive prostatectomy offers enhanced visualisation of the surgical field. Superior clinical outcomes in terms of length of hospital stay, blood loss, and oncologic margins compared with open surgery are reported. Confocal endomicroscopy provides high resolution subsurface cellular imaging in real time and is already in clinical use in gastroenterology and under investigation in other surgical applications. A potential role exists for confocal endomicroscopy to enhance microscopic nerve identification intra-operatively and guide surgical decision making during robot-assisted prostatectomy.

Eligibility Criteria:
Inclusion Criteria:

* Males diagnosed with prostate cancer and undergoing da Vinci radical prostatectomy

Exclusion Criteria:

* Patients under 18 years of age
* Patients with allergy or prior adverse reaction to Fluorescein Sodium
* Patients unable to give informed consent
Protocol DIVAT-Uro

The aim of project DIVAT-URO (Données Informatisées et Validées en Transplantation - Urology) is to organize a thematic network in urology traced on NetWork DIVAT to supplement the medical and biological data of DIVAT existing cohort with parameters of surgical transplantation of kidney and pancreas. These data will concern the transplantation itself and the events and complications related to surgery occurring throughout the follow-up. The collection will involve patients in the cohort DIVAT and future patients. This project will allow us to have the sufficiency of surgical transplantation by increasing the quantity and quality of information gathered thus avoiding the biases commonly upbraided against the retrospective studies. Finally, by supplementing it with new parameters, it will strengthen the medical and scientific interest of the cohort DIVAT and will open new perspectives for clinical trials in surgery and work in epidemiology.Networking of urologists and the expansion of the base DIVAT would carry out research in epidemiology and factors that may play a role in the outcome of renal and pancreatic transplantation. It would also help to define good practices. The first study from the proposed network DIVAT-Uro is assessing the impact of vesico-ureteric reflux on the occurrence of urinary tract infections and effects on survival of the transplant in the recipient adult.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years
* Patients received a kidney transplant or a simultaneous pancreas-kidney transplant
* Patients who read the newsletter and signed the consent form on the computerization of data

Exclusion Criteria:

* Patients aged under 18 years
* Patients who did not sign the consent form
Validation Study of the Malay Version of 3D-CAM

Validation of the Malay version of 3D-CAM, involving two-staged process.

1. Translation and cultural adaptation of 3D-CAM into the Malay language.
2. Testing for Validity and Reliability of the translated 3D-CAM tool to detect postoperative delirium.

1. Translation and Cultural Adaptation

   The research panel, who consisted of experts in the clinical field of anesthesia, did the meticulous process of translation and cultural adaptation of 3D-CAM.

   This process included independent translation by the research panel, reconciliation of two independent translated 3D-CAM, ethics approval prior to pilot study on 20 relevant subjects, back translation into English and finalizing the Malay version of 3D-CAM for the next phase of testing.
2. Testing for Validity and Reliability of the translated 3D-CAM tool

Patients were recruited pre-operatively after reading the patient's information sheet and signing the informed consent.

Post-operatively, two trained assessors separately administered the Malay 3D-CAM on the recruited patients. One of the trained assessors administered the original 3D-CAM on the same patients at a different time. Standard reference of diagnosing delirium was made by a psychiatrist using the DSM V criteria, after interviewing the patients.

1. For validity, the diagnosis of delirium made using the Malay 3D-CAM tool was tested against the standard reference for diagnosing delirium according to the DSM V criteria made by a psychiatrist
2. For inter-rater reliability, the diagnosis of delirium made by two trained assessors using the Malay 3D-CAM tool were statistically compared.
3. For parallel reliability, the diagnosis of delirium made using the Malay 3D-CAM was compared to the original English version of 3D-CAM.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 years old and above
* Patients undergoing non-cardiac surgery

Exclusion Criteria:

* Patients undergoing cardiac Surgery
* Unable to communicate in the Malay Language
* Patients who were in the intensive care unit peri-operatively
* Patients whose surgery was cancelled
* Patients who were deaf and dumb
* Patients who had been diagnosed as delirious or has psychosis history before assessment
* Glasgow Coma Scale of \< 12 / 15
* Patients who remained comatose throughout the investigation
Effect of Protein Intake During Hemodialysis on Blood Pressure and Arterial Stiffness Indices

Open label, randomized, cross-over clinical study comparing the acute effect of high versus low protein meals during dialysis on intradialytic blood pressure, 24-hour ambulatory blood pressure and arterial stiffness indices on maintenance hemodialysis patients.

A series of demographic, anthropometric and clinical data will be collected prior to enrollment. The intervention will last 3 consecutive weeks. Eligible subjects will be randomised to one group (high or low protein meals during dialysis) for one week (3 dialysis sessions). Second week will be a wash out period (patients will not consume meals during dialysis) and during the third week randomised subjects will cross over to the other study group. Every meal will provide 1/3 of daily recommended energy and protein intake (35 kcal/kg body weight/day, 0.7 gr protein/kg body weight/day for low protein meals and 1.5 gr protein/kg body weight/day for high protein meals). All the meals will be prepared in the hospital's kitchen and will be personalized to each patient's preferences. The meal will be given one hour after the start of the session and should be consumed completely during dialysis.

Patients will be evaluated for the following parameters during their midweek dialysis session:

1. Intradialytic blood pressure
2. 24-hour ambulatory blood pressure
3. Arterial stiffness indices (Central Aortic blood pressure, Pulse Wave Velocity, Augmentation Index)
4. Hemodialysis adequacy
5. Nutritional status

Intradialytic blood pressure, 24-hour ambulatory blood pressure and arterial stiffness indices will be evaluated with the use of the brachial cuff-based oscillometric device Mobil-O-Graph NG (IEM, Stolberg, Germany). Urea reduction ratio (URR) and Kt/V (standard and equilibrated) will be used as measures for dialysis adequacy. Possible changes in patients nutritional status will be assessed using the Malnutrition-Inflammation Score (MIS).

Eligibility Criteria:
Inclusion Criteria:

* Patients to have provided informed written consent
* Patients undergoing maintenance hemodialysis for at least 3 months prior to enrollment
* Ability to self-ingest food during the dialysis session

Exclusion Criteria:

* History of malignancy or any other clinical condition associated with very poor prognosis
* Hospitalization for acute myocardial infarction, unstable angina or acute ischemic stroke within the 3 previous months
* Patients receiving parenteral nutrition
* Body mass index (BMI) of \>40 kg/m2
* Bilateral functioning or non-functioning arteriovenous fistula (AVF) and/or arteriovenous graft (AVG) used as dialysis access
* Patients with major amputations (eg lower limbs)
* Women during pregnancy or lactation
* Patients with unsuccessful 24-hour ambulatory recording of blood pressure with Mobil-O-Graph device, in accordance with the current European Society of Hypertension Guidelines.
Artificial Sweeteners in Breast Milk

This study will investigate how some artificial sweeteners (AS) cross from blood to breastmilk in breastfeeding women after oral intake. Moreover, it will be investigated whether the kinetics of AS differ based on the women's body composition (BMI) and metabolic status (diabetes). This will be investigated through a clinical trial in which 60 women divided into three groups (normal weight, overweight and diabetic) will drink a beverage containing four AS. over a period of six hours the women will donate blood and breast milk samples in order to investigate the presence of AS.


Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old
* Able to give consent
* Able to produce enough amounts of breastmilk
* Danish/English speakers
* Pre-pregnancy BMI below 25 (20 subjects)
* Pre-pregnancy BMI above 27 (20 subjects)
* Diabetes type 1 or 2 (20 subjects)

Exclusion Criteria:

* Under the age of 18 years old
* Unable to give consent
* Unable to produce enough amounts of breastmilk
* Non-Danish/English speakers
* If they have consumed artificial sweeteners 24 hours prior to trial
Economisation of Whipple Resection Using Electrosurgical Sealing Device

Including 89 randomised patient, the studies aim is to determine whether an economisation and/or improvement in terms of operating time, drainage fluid, blood loss, time of hospitalisation can be found using an electrosurgical sealing device versus traditional surgical methods such as stitches an ligations.The study is performed for patients undergoing partial pancreatoduodenectomy.


Eligibility Criteria:
Inclusion Criteria:

* resectable tumor

Exclusion Criteria:

* palliative resection
Post Marketing Surveillance of PIRESPA® TAB 200mg (Pirfenidone) for Evaluating the Safety and Efficacy

Post-marketing surveillance of Pirfenidone

Pirfenidone (Pirespa®) is an anti fibrotic drug, which was approved in 2012 in the Republic of Korea for the treatment of patients with idiopathic pulmonary fibrosis (IPF). A post-marketing survey was conducted following the approval to obtain data on the safety and efficacy of pirfenidone for IPF treatment in real-world practice.

Eligibility Criteria:
Inclusion Criteria:

* Among patients diagnosed as idiopathic pulmonary fibrosis, only those who have used the testing drug under the general medical conditions for a certain investigation period after the beginning of the investigation and also signed a the "Personal Information Utilization Agreement" form. However, for those who have already received the drug before the beginning of the investigation, only the subjects whose medical record can be used are included.

Exclusion Criteria:

1. Subjects who is hypersensitive to the active ingredient or additives of this drug
2. Subjects who have severe hepatopathy
3. Subjects who have severe renal disorder (creatinine clearance\<30mL/min) or a terminal renal disease treated by dialysis
4. Subjects who received a combined treatment of fluvoxamine
5. Subjects who have genetic problems, such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Lowlands Saves Lives: A Randomized Trial Comparing CPR-quality Between Face-to-face vs. Lifesaver VR Training

The objective of the Lowlands Saves Lives trial is to compare the quality of cardiopulmonary resuscitation (CPR) between face-to-face versus Lifesaver Virtual Reality smartphone application trained participants using a randomized controlled trial.

In order to optimize survival after out-of-hospital cardiac arrest, basic life support (BLS) training of lay-person volunteers is essential. Face-to-face training has long been considered the standard, but new training-methods have emerged, of which the Lifesaver VR (developed by the UK Resuscitation Council) app seems promising. It is unknown which training method results in the highest quality of cardiopulmonary resuscitation (CPR). Therefore, we conduct this randomized controlled trial in which subjects will be randomized to either one of the two training methods. Following the training, all participants will undergo CPR-quality testing using certified manikins and blinded assessors.

The present study will be conducted during Lowlands Science, a section of the Lowlands music festival exclusively dedicated to science. Lowlands will be held on August 16-18 of 2019 and over 50.000 attendees are expected.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years).
* Provide informed consent.

Exclusion Criteria:

* Alcohol level \>0.5‰ and not able to perform tandem gait test.
* For any reason not being able to partake in the face-to-face or VR-app training (e.g. clear alcohol or drugs intoxication).
* For any reason not being able to perform the CPR test on the CPR-manikin (e.g. clear alcohol or drugs intoxication).