cyrilzakka/clinical-trials huggingface dataset:
Study of the Pathogenicity and Humoral Immune Response Induced by BK Virus in Lung Transplant Recipients

BK virus (BKV) is a ubiquitous virus that infects more than 80% of the population. In case of immunosuppression, BKV can replicate and induce nephropathies in renal transplant recipients or haemorrhagic cystitis in bone marrow transplant recipients. The disruption of the balance between BKV replication and immune control is considered the key element in the development of these pathologies. During lung transplantation, patients undergo intense immunosuppression that favors the reactivation of persistent viruses such as EBV, CMV and probably BKV. Although the data on EBV and CMV reactivation are very clear and allow optimal management, the prevalence of BKV replication and its clinical impact in lung transplant recipients remains unknown at this time.

The aim of this study is to know the incidence and clinical impact of BKV replication in lung transplant recipients. Moreover, the results will help to better understand the interaction between the virus and his host, with a focus on the humoral and cellular immune response against BKV. The results could possibly enable to define predictive markers of BKV replication and of its evolution.


Eligibility Criteria:
Inclusion criteria:

* Lung transplant recipients in Strasbourg University Hospital between 30 June 2018 and 31 December 2022
* Male or female patients, age over 18 years
* Patient having provided informed written consent to take part in the study
* Patient affiliated to Social Security

Exclusion criteria:

* Patient deprived of liberty, by judicial or administrative decision
* Patient under legal guardianship
* Impossibility to give complete information about this study to the patient
Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest

The objective of the trial is to investigate efficacy and safety of ingenol mebutate gel for actinic keratosis applied to large treatment areas once daily for three consecutive days on face, scalp or chest.


Eligibility Criteria:
Inclusion Criteria:

Subjects with 5 to 20 clinically typical, visible and discrete, actinic keratosis (AKs) non-hyperkeratotic and non-hypertrophic AKs within a selected treatment area of sun-damaged skin on either:

* The full face
* The full balding scalp
* A contiguous area of approximately 250 cm2 on the chest

Exclusion Criteria:

* Location of the treatment area (full face, full balding scalp or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC).
* Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO clinical programme on ingenol mebutate gel for larger treatment areas.
* Treatment with ingenol mebutate gel in the selected treatment area within the last 12 months.
* Lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous horn) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).
New Technologies for Intensive Prevention Programs - NET-IPP

In a randomized trial patients hospitalized for myocardial infarction are prospectively enrolled and assigned to either a web-based intensive prevention program or usual care (1 : 1 randomization). The web-based program includes telemetric transmission of data on cardiocascular risk factors (physical activity, blood pressure, body weight) by patients to the study center, e-learning modules by the study center and repetitive electronic contacts by e-mails and apps between a prevention assistant and the patient.

In addition, genetic risk on cardiovascular events will be assessed in all patients of the intervention group by a polygenetic risk score (PRS). Patients of the intervention group are randomly assigned to disclosure of genetic risk vs. no disclosure. The study hypothesis is that disclosure of genetic risk improves cardiovascular risk factor control by increased patient motivation.


Eligibility Criteria:
Inclusion Criteria:

1. Hospitalization due to acute myocardial infarction (ST-elevation or non-ST-elevation myocardial infarction) defined according to valid international guidelines
2. Access to internet and consent to participate in a web-based prevention program
3. Consent for genetic risk assessment for cardiovascular events and risk disclosure according to randomization

Exclusion Criteria:

1. Patient refusal or inability to give informed consent
2. Hemodynamically significant valvular heart disease
3. Exercise limitations due to clinical conditions not related to CAD (such as severe orthopedic disorders,..)
4. Any major non-cardiac condition that would adversely affect survival during the duration of the study (such as cancer with prognosis \< 2 years,..)
5. Inability to cooperate with the protocol, including longterm follow-up
6. Chronic drug and alcohol abuse
Impact of Acetazolamide in Reducing Referred Postoperative Pain

Robotic assisted laparoscopic prostatectomy (RALP) is the standard treatment for prostate cancer, due to the benefits of decreased blood loss and length of stay.The procedure involves removing a man's prostate using a minimally invasive robotic approach under the guidance of a surgeon. In order to gain sufficient access, carbon dioxide (CO2) is used to fill the surgical space in a process termed insufflation. Carbon dioxide is a mainstay in laparoscopic procedures because it is cost-effective, noncombustible and readily excreted via the respiratory system in healthy patients.

Insufflation with CO2, however, has been linked to post-operative referred pain secondary to peritoneal acidosis.This acidosis is suspected to be due to the formation of carbonic acid from the CO2 insufflation.Peritoneal acidosis, and its associated post-operative referred pain, may not be adequately treated with the current standard pain control regimen.


Eligibility Criteria:
Inclusion Criteria:

• Male patients ≥18 years of age undergoing robotic-assisted prostatectomy

Exclusion Criteria:

* Patients with renal insufficiency with serum creatinine \>2.0 mg/dl
* Patients with renal transplant
* Patients with pre-existing metabolic acidosis
* Patients with chronic obstructive pulmonary disease
* Patients with hepatic disease
* Patients with central nervous system disorders
* Patients with hematological disease history
* Patients with pre-existing electrolyte abnormalities
* Patients with hypovolemia
* Patients with lithium or diuretic usage
* Patients with sulfonamides allergy
* Patients with American Society of Anesthesiologists physical status 4 or 5
Effortful Swallow Maneuver for Swallowing Impairment in People With Parkinson Disease

Context: Many people with Parkinson Disease (PwPD) experience swallowing difficulties, particularly with food/liquid going down the wrong way or remaining in the throat after swallowing. Prior studies suggest that exercise-based treatments targeting swallowing strength may be effective in reducing these difficulties.

Research question: Does an exercise-based treatment involving the effortful swallow maneuver improve swallowing function in PwPD?

Study plan: The investigators will study the effects of a four-week intensive swallowing rehabilitation program in PwPD, over a 2-year period.

The investigators will study the effects of a four-week intensive swallowing rehabilitation program in PwPD, over a 2 year period. The program will involve daily practice of the effortful swallowing maneuver, with swallowing function assessed before and after the treatment program using videofluoroscopic x-rays.

Expected outcomes: In other populations, the effortful swallow has shown to address two mechanisms that are thought to underlie swallowing impairment in Parkinson Disease: slowness in achieving airway protection and weakness in muscles responsible for transporting food through the throat. The investigators expect that repeated practice of this maneuver by PwPD will lead to improved airway protection and improved clearance of residue from the throat.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* English-speaking
* Able to follow study instructions
* Neurologist confirmed diagnosis of PD
* Hoehn and Yahr scale score of 2 or 3
* Self-report of one or more swallowing or related symptoms:

  1. Difficulty with secretion management
  2. Coughing at the meal time
  3. Choking on food
  4. Respiratory infection in the past 6 months (other than COVID)

Exclusion Criteria:

* History of head and neck cancer
* Radical neck dissection (e.g. anterior cervical spine surgery) or neck/ oropharyngeal surgery (not excluded - tonsillectomy, adenoidectomy)
* Past medical history of any neurological disease other than PD (e.g. multiple sclerosis, amyotrophic lateral sclerosis, traumatic brain injury, stroke)
* Cognitive or receptive communication difficulties that preclude the participant's ability to follow study instructions provided in English. This will be determined by the participant's physician prior to referring them to the study.
A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis

This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria (2010)
* At least 2 documented clinical attacks within the last 2 years prior to screening or one clinical attack in the years prior to screening (but not within 30 days prior to screening)
* Neurologic stability for greater than or equal to (\>/=) 30 days prior to both screening and baseline
* Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive

Exclusion Criteria:

* Primary progressive multiple sclerosis
* Disease duration of more than 10 years in patients with EDSS score less than or equal to (\</=) 2.0 at screening
* Contraindications for MRI
* Known presence of other neurological disorders which may mimic multiple sclerosis
* Pregnancy or lactation
* Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
* History of or currently active primary or secondary immunodeficiency
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* Active infection, or history of or known presence of recurrent or chronic infection (for example, hepatitis B or C, Human Immunodeficiency Virus \[HIV\], syphilis, tuberculosis)
* History of progressive multifocal leukoencephalopathy
* Contraindications to or intolerance of oral or IV corticosteroids
* Contraindications to Rebif or incompatibility with Rebif use
Effects of Acapella VS CHEST Physiotherapy in Post-Operative CABG Patients

Coronary artery bypass grafting (CABG) is a surgical procedure that is performed to improve blood flow to the heart by bypassing blocked or narrowed arteries. CABG is a major surgery that is associated with significant postoperative complications, including pulmonary complications such as atelectasis and pneumonia. Chest physiotherapy is commonly use to prevent and treat these complications, but its effectiveness in post-operative CABG patients is not well established.

The purpose of this study is to evaluate the effects of Acapella device vs chest physiotherapy on pulmonary function, airway clearance and dyspnea in post-operative CABG patients. The group A will receive (baseline treatment aerosol therapy, ACBT, Mobilization, breathing with arm elevation with addition to using Acapella), while the group B will receive base line treatment. aerosol therapy, ACBT, Mobilization, breathing with arm elevation with addition chest physiotherapy percussing for 20 minute The primary outcome measures of the study will be pulmonary function tests, including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and FEV1/FVC, and Modified Borg dyspnea scale . The secondary outcome measures will be the amount of sputum cleared. The study will be conducted over a period of 6 months after approval of synopsis.

The study will be conducted in a tertiary care hospital in Lahore, Pakistan. Patients who have undergone CABG surgery will be screen for eligibility and those who meet the inclusion criteria will be enroll in the study. Patients who have a history of chronic lung disease, smoking, intubated patient or other respiratory conditions will be exclude from the study


Eligibility Criteria:
Inclusion Criteria:

* both gender
* Patients aged between 55-70 years
* Vitally Stable
* extubated post-CABG day 01 patients
* Patient undergone for the 1st time CABG

Exclusion Criteria:

* With a history of chronic obstructive pulmonary disease or asthma patient
* Intubated patient
* Surgical complication after CABG
* With a history of smoking
* Patients who have undergone thoracic surgery in the past
* Patients with a history of neuromuscular disorders
* Patients with a history of heart failure
* Vitally unstable or on ventilator post CABG patients
Personal Protective Equipment Effects

Severe acute respiratory syndrome coronavirus-2 transmits through droplets; thus, oral, nasal, and conjunctival mucosas are related to contamination, and wearing personal protective equipment (PPE) is strongly suggested. Several communication problems between the patient and healthcare workers related to PPE use are reported. In this study, investigators aimed to investigate changes in the acoustic parameters of speech sounds when different PPE are used.

It was planned as a cross-sectional study enrolled 18 healthy male and female participants. After the informed consent, participants were asked to pronounce a \[ɑː\] vowel for at least 3 seconds for voice quality estimation. Afterward, all Turkish vowels were produced for a minimum of 200 ms. Finally, three Turkish fricative consonants (\[f\], \[s\], \[ʃ\]) were produced in consonant/vowel/consonant format and in different vowel contexts within a carrier sentence. Recordings were repeated for the following conditions: no PPE, surgical-mask, N99-mask, face shield, surgical-mask+faceshield, and N99+faceshield. All recordings were analyzed with proper statistical methods.

Eligibility Criteria:
Inclusion Criteria:

* native Turkish speakers

Exclusion Criteria:

* having an acute respiratory system infection history of any vocal fold surgery
Safety and Efficacy of Zoledronic Acid in Patients With Breast Cancer With Metastatic Bone Lesions

The objective of this study is to assess the clinical benefit of two different dosing schedules of zoledronic acid in patients with metastatic bone lesions from breast cancer who have already been treated with zoledronic acid for about one year.


Eligibility Criteria:
Inclusion criteria:

* Female patients ≥ 18 years of age.
* Written informed consent given.
* Histologically confirmed Stage IV breast cancer with at least one bone metastasis radiologically confirmed.
* Previous treatment with zoledronic acid every 3-4 weeks, for 9-12 infusions over no more than 15 months.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2 .
* Life expectancy ≥ 1 year.

Exclusion criteria:

* More than 3 months since last infusion of Zoledronic Acid (Zometa®).
* Treatments with other bisphosphonate than Zoledronic Acid (Zometa®) at any time prior to study entry.
* Serum creatinine \> 3 mg/dL (265 μmol/L) or calculated (Cockcroft-Gault formula) creatinine clearance (CLCr) \< 30 mL/min CrCl = ({\[140-age (years)\] x weight(kg)}/ \[72 x serum creatinine (mg/dL)\])x 0.85
* Corrected (adjusted for serum albumin) serum calcium \< 8 mg/dl (2 mmol/L) or \> 12 mg/dL ( 3.0 mmol/L).
* Current active dental problem including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a recurrent or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
* Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants).
* Pregnant patients (with a positive pregnancy test prior to study entry) or lactating patients. Women of childbearing potential not using effective methods of birth control (e.g. abstinence, oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide).
* History of non-compliance to medical regimens or potential unreliable behavior.
* Known sensitivity to study drug(s) or class of study drug(s).
* Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
* Use of any other investigational agent in the last 30 days.
Prevention of Perinatal Sepsis (PoPS): Evaluation of Chlorhexidine Wipes of Birth Canal and Newborn

The purpose of this study is to evaluate whether use of the disinfectant chlorhexidine administered to the birth canal during labour and newborn at delivery can protect a woman and her baby from bacterial infections after birth. If effective, this could be used as an inexpensive alternative to antibiotics to prevent newborn infections in resource-poor countries.

We are conducting a randomized, controlled clinical trial in Soweto, South Africa to evaluate the efficacy of 0.5% chlorhexidine wipes of the birth canal during labour and of the infant at birth in reducing 1) vertical transmission of leading pathogenic bacteria from mother to child during labour and delivery, and 2) incidence of neonatal sepsis and maternal peripartum infection, in comparison to external genitalia sterile water wipes. In conjunction with this, we will compare vaginal carriage of bacteria commonly associated with neonatal sepsis and maternal peripartum infection among HIV-infected and non-infected pregnant women who deliver at the only public hospital in Soweto, and will characterize the burden of disease and risk factors for maternal peripartum infection and serious neonatal infections in this population by conducting active prospective surveillance.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* Plan to deliver at Chris Hani Baragwanath Hospital or one of its satellite clinics
* Plan to remain in Soweto for at least two months after delivery
* Are able to understand and give informed consent
* Are at least 15 years old at time of registration

Exclusion Criteria:

* Planned delivery by caesarean section
* Antenatal ultrasound revealing major fetal congenital anomalies
* Have known or suspected condition in which vaginal exams are contraindicated, e.g. placenta previa
* Have a history of allergic reaction to any topical antiseptic solution
* Present to labour ward with infant born before arrival
* Present to labour ward with significant vaginal bleeding during labour
* Present with known intrauterine fetal death prior to randomization
* Subject noted to be in full cervical dilatation or have baby's head on perineum
* Infant noted to be in face presentation on first vaginal examination
* Noted to have genital ulcers present on first vaginal examination
Influence of Pramipexole on the QT Interval of the ECG in Healthy Male and Female Volunteers

The objective of the study is to assess that pramipexole does not prolong the QT interval more than placebo


Eligibility Criteria:
Inclusion Criteria:

* All participants in the study need to be healthy males or females 21 to 50 years of age
* Body mass index (BMI) ranging from 18.5 to 29.9 kg/m2
* Signed written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
* Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
* Participation in another trial with an investigational drug (≤ 30 days prior to administration or during the trial)
* Heavy smoker (\> 10 cigarettes or \> 3 cigars of \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
* Any deviation of a laboratory value that is considered to be of clinical relevance
* Excessive physical activities within the last week before the trial or during the trial
* Hypersensitivity to pramipexole, moxifloxacin and/or related drugs of these classes
* Supine blood pressure at screening of systolic \< 100 mmHg and diastolic \< 60 mmHg
* Heart rate at screening of \> 80 beats per minute (bpm) or \< 40 bpm
* Any screening ECG value outside of the reference range of clinical relevance including, but not limited to Pulse Rate interval \> 220 ms, QRS interval \> 115 ms, QTcB or QTcF \> 450 ms, or QT (uncorrected) \> 470 ms
* Subjects involved in passenger transport or operation of dangerous machines

For Female Subjects:

* Pregnancy
* Positive pregnancy test
* No adequate contraception (adequate contraception: e.g. sterilization, intrauterine device, oral contraceptives)
* Inability to maintain this adequate contraception during the whole study period
* Lactation period