cyrilzakka/clinical-trials huggingface dataset:
INSTI® HCV (Hepatitis C Virus) Antibody Self-Test Contrived Result Interpretation

The purpose of this Interpretation Assessment was to document if "lay" people, non-professional and inexperienced in self-testing, were able to successfully perform the steps to use a Hepatitis C Virus (HCV) Self-Test (HCVST) device, without product familiarization \[demonstration\].

The intent of this study was to collect data regarding the result interpretation of contrived results of INSTI HCV ST. The contrived test devices refers to mock test devices pre-made by bioLytical Laboratories Inc. Each contrived/mock test device was assigned to an ID number to be randomly provided to the participants.

Primary Objectives were to document and record the following:

•Successful interpretation of contrived test results using mock test devices (strong positive, weak positive, negative and a range of invalid results).

Depending on the device being evaluated participants received a contrived INSTI® HCV Antibody Self Test membrane unit.

Participants were asked to interpret "mock" results \[read contrived device results using the reference chart in the Instructions for Use (IFU)\].

Participants were recruited from the Ezintsha Research Site which was a low-prevalence area and the Yeoville Harm Reduction Site which was a high-prevalence area in the city of Johannesburg in the Republic of South Africa. For the purposes of this assessment, the participant population was the general population. The participants did not have any experience in conducting any rapid diagnostic self-test using standard test kits, nor were they familiar with the prospective HCVST devices prior to entering into this mock result interpretation assessment.

Eligibility Criteria:
Inclusion Criteria:

* Understands and sign the written informed Consent form
* Able to complete the required testing on the allocated testing day\[s\]
* Able to speak/read English
* ≥18 years of age
* Provide a level of education (minimum grade 7)

Exclusion Criteria:

* Does not meet the inclusion criteria
* A practicing medical healthcare professional \[doctor, nurse or counsellor that performs testing with Rapid Tests\]
* Has used blood-based RDT for self-testing previously, either HIV or HCV
* Any condition which, in the opinion of the facilitator, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of the mock result interpretation assessment, consent form and questionnaire etc. or bias the outcome
Multicenter Cohort Study on Osteoporosis

This is a multicenter cohort study on osteoporosis in nine cities of China which locate in the east, south, north, west, middle of China. At least 3000 middle-aged and elderly permanent residents (women aged from 45 to 79, and men aged from 50 to 79) in every city will be enrolled. Residents with severe mental diseases, physical diseases or acute infectious diseases who could not cooperate with the survey as well as lactating or pregnant women were excluded. All the enrolled residents who signed informed consent will finish questionnaire including demographic characteristics, history of smoking, alcohol drinking, falls and fracture, family genetic history, chronic diseases and medicine,diary and physical practice，stool and urine status. Osteoporosis risk, health status, constitution of traditional Chinese medicine (TCM),symptoms of kidney yang deficiency in TCM，living environment,sweating status will be evaluated. Fasting blood glucose test and other blood tests for liver and kidney function,bone metabolism，vitamins，vitamin D metabolism and transportation as well as calcium and phosphate metabolism, will be performed. Bone mineral density and physical examinations (height, weight, waist circumference, hip circumference,grip,sit-to-stand test, tongue coating and pulse) will also be performed at enrollment and every two years after enrollment. DNA of blood cells will be preserved for specific study such as SNP analyses.Tongue coating and feces will be preserved for microflora analyses.


Eligibility Criteria:
Inclusion Criteria:

* permanent residents
* women aged from 45 to 79, and men aged from 50 to 79

Exclusion Criteria:

* severe mental diseases, physical diseases or acute infectious diseases who could not cooperate with the survey.
* lactating or pregnant women.
Predictive Risk Factors for Pancreatic Fistula Grade C After Pancreaticoduodenectomy

Pancreatic fistula (PF) grade C, defined by the International Study Group of Pancreatic Fistula (ISGPF) is associated with a life-threatening complication after pancreaticoduodenectomy(PD). Therefore, The aim of this study is to clarify the risk factors for grade C PF by Japan and Taiwan cooperative project.

Pancreatic fistula (PF) grade C, defined by the International Study Group of Pancreatic Fistula (ISGPF) is associated with a life-threatening complication after pancreaticoduodenectomy(PD). The rate of grade C PF has been reported 2.5-6%, however, it is critical complication after PD. A large number of enrolled patients will be needed to clarify the risk factors for grade C PF. Therefore, this study design is prospective large observational study at multi-center in Japan and Taiwan.

Eligibility Criteria:
Inclusion Criteria:

1. Disease of pancreatic head or periampullary lesions to require pancreaticoduodenectomy
2. Age: 20 years or older
3. PS (ECOG performance status scale) 0-1 at the time of enrollment
4. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

1. patients with severe respiratory disorder required oxygen inhalation
2. patients with severe liver dysfunction
3. patients with chronic renal failure with dialysis
4. patients who are unfit for this study as determined by the attending physician
A Dose-Finding Study of the Second Mitochondrial Activator of Caspases (SMAC) Mimetic Debio 1143 When Given in Combination With Avelumab to Participants With Advanced Solid Malignancies and to Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Platinum-Based Therapy

The study is primarily designed to assess the safety and tolerability of escalating oral doses of Debio 1143 and preliminary anti-tumour activity when combined with the standard dose of avelumab in participants with advanced solid malignancies.


Eligibility Criteria:
Inclusion Criteria:

Part A • With advanced solid malignancies who are not eligible for standard therapy or for whom standard therapy has failed

Part B

• With histologically or cytologically confirmed NSCLC of stage IIIB or IV (per 7th International Association for the Study of Lung Cancer classification) that has progressed after one line of platinum containing doublet chemotherapy

Part A and B

* Willingness and feasibility to provide a tumor biopsy sample both at screening and during treatment (If archived tumor material not older than 1 year is available, then the screening biopsy will not be performed).
* Participants with prior radiation therapy must have measurable disease in non-irradiated sites or documented evidence of progression within the radiation field.
* With known central nervous system (CNS) must have completed primary brain therapy (such as whole brain radiotherapy, stereotactic radiosurgery, or complete surgical resection) and must have remained clinically stable, asymptomatic, and without steroid treatment for at least 21 days.

Exclusion Criteria:

* Not recovered (i.e. toxicity grade \>1) from prior investigational drug and/or anti-cancer therapy (chemo- or palliative radiotherapy).
* Symptomatic and/or progressive brain metastasis or carcinomatous meningitis.
* Immunosuppressive agents (such as steroids) for any reason should be tapered off before initiation of study treatment (except low-dose prednisone at a total dose of up to 10 mg/day).

Part B only

* Tumor activating epidermal growth factor receptor (EGFR) mutation(s) or anaplastic lymphoma kinase (ALK)/ROS1 translocation/rearrangement (testing required in non-squamous participants if status is unknown).
* More than one prior line of chemotherapy and one line of anti-PD1/PDL1 therapy.
Comparative Study of PDVF and Polypropylene Transobturator Suburethral Tapes

This study evaluates the effectiveness and complications of polyvinylidene fluoride (PVDF) and polypropylene (PP) transobturator suburethral tapes (TOTs) in the treatment of female stress urinary incontinence. Half of participants will be operated with PVDF-TOTs, while the other half will be operated with PP ones.


Eligibility Criteria:
Inclusion Criteria:

* Women with stress urinary incontinence.
* Women with stress-predominant mixed urinary incontinence.

Exclusion Criteria:

* Incapacity to understand the information or give their consent.
* Previous anti-incontinence surgery with slings.
* Low pressure urethra (MUCP \< 20cmH2O).
* Neurogenic bladder.
Post-extubation Assessment of Laryngeal Symptoms and Severity

The goal of this study is to learn more about voice and airway problems that patients experience during and after the time patients have an oral endotracheal tube in patients' airway to help patients breathe while receiving mechanical ventilation in an intensive care unit (ICU).


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Required mechanical ventilation via an oral endotracheal tube
* Anticipated intubation ≥8 hours

Exclusion Criteria:

* Pre-existing dysphonia, dysphagia
* Pre-existing central nervous system, neuromuscular, or connective tissue disease
* Prior tracheotomy and/or tracheotomy placed prior to enrollment
* History of major thoracic surgery (e.g., sternotomy, thoracotomy) prior to the current admission
* Head and/or neck disease
* Head and/or neck surgery other than tonsillectomy
* Known or suspected anatomical abnormalities or pre-intubation trauma of the oral cavity, pharynx, larynx, or esophagus
* Unlikely to be extubated (i.e., expected death)
Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery

Acquired Von Willebrand disease (type 2A) has been described in patients with severe aortic stenosis, the association of aortic stenosis and Digestive bleeding due to this phenomena has received the name of Heye´s syndrome.

We propose that administering Desmopressin (DDAVP) in patients scheduled to aortic valve replacement surgery will reduce blood loss and transfusion rate.

this was a pilot study

Randomized Controlled trial compared with placebo in a double blind fashion. Subjects with severe aortic stenosis (transvalvular gradient \>50 mmHg or valvular area of lass than 1 cm2) scheduled for aortic valve replacement were enrolled.

the day of surgery blood samples were taken in order to confirm diagnosis (factor VIII activity and Protein electrophoresis for Von Willebrand´s multimers) and then 0,3 mcg/k of DDAVP or saline equally labeled as "study drug" were administered en 30 minutes a half hour before incision.

Blood loss, postoperative hematocrit and transfusion requirement were measured, plasma sodium was measured as a safety issue.

Eligibility Criteria:
Inclusion Criteria:

* severe aortic stenosis defined as mean transvalvular gradient greater or equal to 40 mmHg ot transvalvular area less than 1 cm2
* scheduled for aortic valve replacement surgery

Exclusion Criteria:

* combined surgery (plus coronary artery bypass graft or other valve replacement/plasty)
* Infective Endocarditis
* previously known haemostatic disorder
* previous treatment with oral anticoagulants or IIb-IIIa inhibitors (we did not exclude those on acetyl-salicylic acid)
Clinical Outcomes in Pediatric Obsessive-Compulsive Disorder

Obsessive-Compulsive Disorder (OCD) is a common neuropsychiatric illness beginning in childhood. Effective OCD treatments include cognitive-behaviour therapy (CBT) and medications but access to treatment is difficult and does not systematically include parents. The investigators will evaluate clinical and neural effects of Group-based Family CBT (GF-CBT), via a case-control study including: Group 1 - OCD cases receiving GF-CBT (N=90); Group 2 - OCD waitlist cases (N=90). Effects will be measured between baseline and completion of 12 GF-CBT sessions: comparing OCD severity and functioning changes between Groups 1 and 2.

Effective OCD treatment approaches in children and youth include cognitive-behaviour therapy (CBT) and serotonergic medications; however, the disorder is under-diagnosed and access to care is frequently delayed or difficult to obtain. Moreover, despite the important role of family accommodation as an outcome predictor, standard CBT does not systematically include parents and mechanisms of response are not fully understood. The investigators propose to address this challenge by evaluating a novel treatment approach called Group-based Family CBT (GF-CBT).

To determine clinical and neural effects of GF-CBT, we will perform a case-control study of two groups: Group 1 - OCD-affected youth receiving GF-CBT treatment (N=90); Group 2 - OCD-affected youth receiving no new treatment (waitlist controls; N=90).

The investigators will collect clinical outcome data related to OCD severity, individual and family functioning at four time points for Group 1 subjects and at two time points for Group 2 subjects. For Group 1 subjects, these time points include baseline, at midpoint, at the completion of 12 sessions, and at one-month follow-up (all time points are +/- one week). For Group 2 subjects, time points will be at baseline and after a time delay equivalent to completion of 12 GF-CBT sessions. Clinical measures will be used to compare changes between GF-CBT treatment and waitlist-control groups (Groups 1 versus 2).

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 5-18 years old
* Ability of subject and parent to provide informed assent/consent
* English-speaking
* Current DSM IV-TR Axis I diagnosis of childhood-onset OCD; Moderate to severe OCD (CY-BOCS≥16/40)

Exclusion Criteria:

* Current diagnosis of bipolar disorder, psychosis, mental retardation or pervasive developmental disorder (e.g., autism), and current or past substance dependence/abuse
Neoadjuvant Response-guided Treatment of HER2 Positive Breast Cancer

The purpose of this trial is to evaluate efficacy and toxicity of either the combination of docetaxel, trastuzumab sc and pertuzumab (arm A) or trastuzumab emtansin (arm B). Switch of therapy to the opposite treatment alternative is applicable in case of lack of response after two courses of treatment, or for medical reasons under exceptional circumstances (drug reaction, other medical conditions) at any point. After termination of the primary treatment follow-up for five years.

A translational subprotocol is a mandatory part of the study protocol, with exception for the use of PET-CT evaluations.

Patients with HER2-positive tumors \>20 mm or verfied regional lymph node metastases are randomized to either arm A, the combination of docetaxel, trastuzumab sc (Herceptin SC®) and pertuzumab (Perjeta®) or arm B, trastuzumab emtansin (Kadcyla®). Switch to the opposite treatment is performed in case of lack of response after evaluations with mammography and ultrasound, alternatively MRI breast after the 2nd, 4th and 6th course of treatment.

Postoperative treatment, trastuzumab, radiotherapy, eventual endocrine treatment) according to standard guidelines. Structured follow-up visits yearly for five years, including reporting of persistent treatment-related toxicity, HRQoL, recurrence and death.

The trial contains also a translational subprotocol:

1. PET-CT using FDG, confined to the chest, is performed before start, and after the 2nd and 6th course (functional imaging, optional).
2. Core biopsies from the tumor are collected before start and after the 2nd course of treatment. If residual tissue is available, samples are collected from the surgical sample
3. Blood samples are collected repeatedly during the ongoing treatment and yearly follow-up
4. FNAs from metastases in case of recurrence during follow-up

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Patients with breast cancer confirmed by histology, characterized by immunohistochemistry for ER, PR, HER2 and proliferation marker
3. Tumor and blood samples available. HER2 type confirmed by ISH
4. Age 18 years or older. Elderly patients in condition adequate for planned therapy
5. Primary breast cancer \>20mm in diameter and/or verified lymph node metastases
6. Adequate bone marrow, renal, hepatic and cardiac functions and no other uncontrolled medical or psychiatric disorders
7. LVEF ≥55%
8. ECOG performance status 0-1
9. Primary breast cancer as defined in p. 5 plus at most 2 morphologically characterized well-defined distant metastases accessible for stereotactic radiotherapy, provided that this treatment is available

Exclusion Criteria:

1. Distant metastases, including node metastases in the contralateral thoracic region or in the mediastinum
2. Other malignancy diagnosed within the last five years, except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix
3. Patients in child-bearing age without adequate contraception
4. Pregnancy or lactation
5. Uncontrolled hypertension, heart, liver, kidney related or other medical or psychiatric disorders
PK/PD of High Dose Pip/Tazo in Obese Patients

Worldwide rates of obesity have doubled in the last 30 years, and obesity has been associated as a risk factor for hospital-acquired infections and increased occurrence of death in critically-ill patients. Piperacillin/tazobactam is a commonly prescribed antibiotic for critically ill patients with an infection, however, limited information exists for dosing this drug in obese patients. In these limited reports, standard doses of piperacillin/tazobactam given to the small number of obese patients resulted in lower blood concentrations, which could lead to inadequate killing of bacteria. The purpose of this study is to compare blood concentrations from standard piperacillin/tazobactam dosing compared to higher dosing regimens in obese patients. This study will also include information on the safety and tolerability of the higher dose regimens. The study investigators believe that the higher dosing regimen will produce adequate blood levels in obese patients and will not add any more risk of harm to obese patients receiving this higher dose.


Eligibility Criteria:
Inclusion Criteria:

* BMI greater than or equal to 30 kg/m2
* Weight at least 105 kg
* Age 18-89 years of age
* Prescribed piperacillin/tazobactam at standard doses for suspected or confirmed infection(s)
* English or Spanish speaking
* Central line access

Exclusion Criteria:

* Do not meet specified inclusion criteria
* Hepatic impairment classified by Child-Pugh Class B or greater
* Documented pre-existing seizure disorder
* Documented pre-existing hematologic disorder
* Pregnancy
* Documented allergy or contraindication to beta-lactams or tazobactam
A Study of Intraperitoneal Paclitaxel in Combination With SOX Compared With SOX Alone in Gastric Cancer With Malignant Ascites

This study is designed to compare the efficacy of intraperitoneal paclitaxel in combination with SOX, with SOX alone in the first-line treatment of gastric cancer with malignant ascites


Eligibility Criteria:
Inclusion Criteria:

* had a histologically proven adenocarcinoma of the gastroesophageal junction, or stomach that was locally advanced (inoperable) or metastatic
* malignant ascites(over pelvic cavity in CT scan and confirmed by cytology)
* an Eastern Cooperative Oncology Group performance status of 0 to 2
* adequate renal, hepatic, and hematologic function

Exclusion Criteria:

* previous chemotherapy or radiotherapy (unless in the adjuvant setting)
* uncontrolled cardiac disease, or other clinically significant, uncontrolled
* coexisting illness or previous or concurrent cancer
* HER2 positive and willing to use trastuzumab
The Impact of Different Filling Pressures in Operative Outpatient Hysteroscopy on the Procedure Success Rates and Associated Pain.

The study aims to compare different filling pressures in operative outpatient hysteroscopy. Women will be divided into 3 groups. The hysteroscope will be introduced in the uterine cavity. Saline will be used as the distension medium and the pressure will be 80mm Hg in group1, 60mm Hg in group 2 and 40mmHg in group 3.

240 women will be randomly divided into 3 groups, each containing 80 women. Randomisation will be performed using a computer generated random numbers and sealed envelopes.

Full history will be taken followed by general and local examination. One hour before the procedure all women will receive diclofenac 100mg (Voltaren@ Novartis Switzerland). The procedure will be done in the lithotomy position. Hysteroscopy will be done using a 5mm outer diameter continuous flow hysteroscope with a French working channel and a 30 degrees direction of view provided by Techno GmbH and CO. The hysteroscope will be introduced using the vaginoscopy technique, in which no speculum will be used. The cervix will be detected and the external os will be identified using the hysteroscope. The hysteroscope will be introduced in the uterine cavity. Saline will be used as the distension medium and the pressure will be 80mm Hg in group1, 60mm Hg in group 2 and 40 mmHg in group 3. Randomisation will be double blind, neither the operator nor the patient will know the pressure during the procedure, a third party will set the pressure according to the computer generated random numbers. If the procedure cannot be completed, the operator will ask for the pressure to be adjusted to 80mm Hg, which is the usual pressure used in Cairo university hospitals, or more if needed. In this case the operator will document in the data collection form that the procedure could not be completed with the pre-set pressure.

The anterior wall, posterior wall and tubal ostea will be visualised, any polyps, adhesions septa, congenital malformations or submucous fibroids will be noted. Endometrial biopsy will be taken using a semi-rigid, double action oval serrated biopsy forceps 40cm 50Charr Tecchno medical GmbH. The used scissor will be a single action semi-rigid rounded tip scissors Tecchno medical GmbH.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years
* Indication to have an operative outpatient hysteroscopy like endometrial polyp, need for endometrial biopsy, intrauterine adhesions, intra uterine device (IUD) retrieval or intrauterine septum resection.
* Consents to participate in the study

Exclusion Criteria:

* Premenstrual and mid-menstrual patients.
* Patients with missed periods.
* Patients with known cardiac disease.
Efficacy and Safety of Levetiracetam in Routine Clinical Practice in Czech and Slovak Republics, Hungary, and Romania.

To evaluate, over 1 year period, the efficacy and safety of newly prescribed levetiracetam as add-on treatment (POS, myoclonoc seizures in JME and PGTCS in IGE) or primary monotherapy (partial onset seizures) in adult and paediatric patients within the approved age limits in routine clinical practice in Czech and Slovak Republics, Hungary, and Romania. Non-interventional study.


Eligibility Criteria:
Inclusion Criteria:

* diagnoses of partial onset seizures (POS) with or without secondary generalisation or Juvenile Myoclonic Epilepsy (JME) or another IGE with PGTCS
* newly prescribed levetiracetam as add-on treatment (POS, myoclonic seizures in JME and PGTCS in IGE) or monotherapy (partial onset seizures only) in newly diagnosed patients. Newly prescribed means inclusion of the patients in whom a decision has been made to prescribe LEV and the first dose is just to be prescribed.
* age 4 years or above for partial onset seizures, 12 years or above for MS in JME or PGTCS in IGE, 16 years or above for monotherapy
* patient written informed consent

Exclusion Criteria:

* indications other than those defined in inclusion criteria
* history of allergic or anaphylactic reactions to levetiracetam or other pyrrolidone derivatives and excipients included