cyrilzakka/clinical-trials huggingface dataset:
Prevalence and Impact of COVID-19 on Maternal and Infant Health in African Populations

There is growing evidence that COVID-19 threatens maternal and perinatal health. Pregnant women are at higher risk of severe complications (severe pneumonia, hospitalizations, intensive care unit admission, invasive mechanical ventilation, extracorporeal membrane oxygenation) and death compared to age-matched non-pregnant women. On the other hand, the number of confirmed COVID-19 cases reported in sub-Saharan Africa (SSA) continues to increase, where the highest maternal mortality rates in the world are registered. The World Health Organization (WHO) estimates that this region alone accounted for roughly two-thirds (196 000) of all maternal deaths in 2017, which among other reasons is explained by the inequalities in access to quality antenatal care (ANC) services and the low numbers of skilled health workers in the region. The spread of SARS-CoV-2 in SSA is threatening the already fragile health services, affecting mainly the most vulnerable populations such as pregnant women.

This project aims to describe the burden and effects of SARS-CoV-2 infection during pregnancy in women living in malaria endemic areas and high prevalence of HIV infection. Pregnant women attending ANC clinics in selected sites from Libreville and Lambaréné (Gabon) and Manhiça (Mozambique) will be enrolled in a cohort study to determine the frequency of SARS-CoV-2 infection and COVID-19 during pregnancy and its effects on maternal and neonatal health. Participants will be tested for SARS-CoV-2 infection whenever reporting respiratory symptoms suggestive of COVID-19 during routine ANC follow-up and six weeks after the end of pregnancy. The presence of antibodies (IgG/IgM) against SARS CoV-2 in blood samples will be determined. The clinical presentation of COVID-19 in pregnancy will be also characterised, and the incidence of infection during pregnancy and the risk factors of maternal and neonatal morbidity and mortality associated with SARS-CoV-2 infection and the frequency of mother- to- child transmission of SARS-CoV-2 will be assessed.

The findings of this project will contribute to the understanding of the impact of SARS-CoV-2 and COVID-19 among pregnant women living in SSA countries where malaria and HIV infections are highly prevalent.


Eligibility Criteria:
Inclusion Criteria:

* Permanent resident in the study area
* Agreement to deliver in the study site's maternity(ies) wards

Exclusion Criteria:

* Planning to move out the study area in the following 7 months from enrolment
Improving Bowel Preparation for the Colon Capsule

Colon capsule endoscopy is a technology that has been developed as a noninvasive method of examining the large bowel. The biggest limitation to its use has been finding a bowel preparation that will both clean the colon adequately for good visualization of the mucosa and also help propel the capsule through the colon. Most studies have been conducted in Europe using bowel preparation medications that are not approved for use in North America.

The purpose of this study is to compare a combination of polyethylene glycol (PEG) and prucalopride to Picosalax and prucalopride to determine which regime will give a better colon cleanse for the colon capsule. Both PEG and Picosalax are bowel preparations that are used routinely for colonoscopy in Canada. Prucalopride is a new medication recently approved for use in Canada which improves intestinal motility and should help with colon capsule transit.

Patients who are being referred for colonoscopy will be enrolled in the study and randomized to one of the bowel preparation regimes. They will undergo a split-dose bowel preparation with either PEG or Picosalax, which is routine for colonoscopy. As part of the standard bowel preparation, patients randomized to the Picosalax group will take dulcolax three nights before the test and then again two nights before the test. The evening before the test patients will take either PEG 2L or one sachet of Picosalax. The following morning they will take another dose of either PEG (2 Liter container) or one sachet of Picosalax. They will then ingest the colon capsule and a dose of Prucalopride that morning. After 7 hours they will return to the endoscopy unit where they will undergo a colonoscopy, which is the standard of care for examination of the colon.

The images from the colon capsule will be reviewed and the quality of bowel preparation will be graded using a previously validated scale. It is hypothesized that the Picosalax and prucalopride regime will give a better cleanse for the colon than PEG and prucalopride as there will be less turbid fluid in the colon and allow for a better view of the mucosa. Polyp detection and abnormalities of the mucosa detected with the colon capsule will also be compared to polyps and abnormalities detected at the time of colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between the ages of 18 and 75
* Patients being referred for colonoscopy

Exclusion Criteria:

* Symptoms of dysphagia
* Bowel obstruction or ileus
* Known stricture or fistula
* Inflammatory bowel disease
* Previous small or large bowel surgery
* Severe gastroparesis or motility disorder
* Renal impairment (GFR\<55 within 3 months of study)
* Congestive heart failure (NYHA III or IV)
* Ischemic heart disease
* Cirrhosis or severe hepatic dysfunction (ascites or lab result INR\>2)
* History of serious arrhythmia
* Pregnancy
Compliance of Initial Empiric Antimicrobial Therapy

Hospital infections comprise about half of all undesirable complications related to hospital treatment. In case of bacterial infection administration of antimicrobial agent is a therapy of choice. For maximum effectiveness, antimicrobial agents should be administered quickly in optimal doses. Moreover, the therapeutic concentration of properly selected drugs should be achieved as soon as possible. The relation between delays in the administration of antibiotics and increased mortality is well known. That is why proper empiric therapy is so important. Before antimicrobial investigation is completed, which may last up to 72 hours, a wide-spectrum antimicrobial should be administered according to the type of infection, its origin, and the characteristics of the local pathogens.

The objective of this study is to compare the initial choice of empiric antimicrobial therapy and the results of both microbiological identification and susceptibility/resistance analysis of isolated pathogens.

This project was designed as a prospective cohort study. Analysis was performed in a large multidisciplinary academic hospital and trauma center. All decisions on empiric therapy with antimicrobial used in infections caused by multidrug-resistant pathogens, that are made in different hospital wards except intensive care, are required by hospital procedures to be confirmed by intensivists. In our analysis, the initial choice of empiric therapy in the hospital wards other than the critical care unit was compared with the results of microbiological investigations and susceptibility/resistance analyses of isolated pathogens.

Accurate microbial identification was performed with a VITEK® 2 automatic testing system. The microbroth dilution method with VITEK® 2 AST cards was used for the antibiotic susceptibility testing of isolated pathogens.

Microbiological analyses were performed between 2018 and 2020 according to the regulations of the European Committee on Antimicrobial Susceptibility (EUCAST, version 9.0, 2019) and the National Reference Centre for Susceptibility Testing (NRCST, Warsaw, Poland).


Eligibility Criteria:
Eligibility Criteria:

- all patients in whom, based on clinical signs and symptoms, an infection is suspected, and an administration of antimicrobial agents as empiric therapy was necessary

Eclusion Criteria:

- none.
Sb-705498 Rectal Pain Study

SB-705498 has demonstrated efficacy in several preclinical and human experimental pain models. This study will investigate the efficacy of SB-705498 in patients with rectal pain. This will be a double-blind, placebo-controlled, two-way crossover study. 21 patients with faecal urgency (Group 1), and 21 patients with IBS (Group 2) will complete this study.


Eligibility Criteria:
Inclusion Criteria:

* Female/male aged 18-65.
* Women of child bearing potential must use an effective method of contraception
* Faecal urgency as defined by Chan
* ECG, which has no abnormalities
* Normal Clinical labs
* Informed consent and understand protocol requirements
* IBS subjects: Has irritable bowel syndrome (IBS) as defined by Rome II criteria
* Rectal hyperalgesia

Exclusion Criteria:

* Any clinical or biological abnormality found at screen (other than those related to the disease under investigation)
* History of alcohol, substance or drug abuse
* Uncontrolled hypertension
* A history or presence of cardiovascular risk factors
* Participation in a trial within 3 months before the start of the study
* History of allergy
* Unable to withdraw from analgesic medications for their rectal hyperalgesia (opioid-dependent patients can be included if they are willing to withdraw from their opiate medication
Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk

Infections are common and associated with poor outcomes as well as high financial costs after kidney transplantation. Identifying and implementing strategies to reduce infections after kidney transplantation is important for improving patient outcomes. This study seeks to determine the feasibility of body surface area-based dosing of mycophenolate compared to standard dosing of mycophenolate in a pilot randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Adult transplant recipients ≥18 years of age who have a functional allograft and have undergone kidney transplantation between six months and two years prior to study enrollment
* Receiving mycophenolate mofetil for maintenance transplant immunosuppression at the time of the screening visit

Exclusion Criteria:

* Evidence of rejection on routine six month post-transplant biopsy
* Prior intolerance to mycophenolate mofetil necessitating drug discontinuation
* Are or are planning to become pregnant, due to inability to take mycophenolate
* Are marginally housed, due to concerns regarding routine follow-up
* Are actively participating in a different interventional trial that may affect immunosuppression dosing
* Are unwilling to consent to participate
* Institutionalized individuals or prisoners
* Are actively abusing illicit drugs or alcohol
* Have a history of poor or doubtful compliance (e.g., frequently missed appointments)
* Have cognitive impairment prohibiting participation in the study
Defining a Technique for the Use of Cryogenic Catheters for Biopsy and Ablation for the Diagnostic and Treatment of Pulmonary Lesions: An Ex-Vivo Human Lung Model Study.

Developing a standardized methodology for the use of novel cryogenic catheters for transbronchial cryobiopsy and cryoablation of pulmonary lesions.

Surgical lung biopsy (SLB) and surgical resection are the current gold standard for both tissue sampling and ablation of pulmonary lesions. Albeit the use of minimally invasive surgical techniques (VATS), these interventions are frequently associated with complications which include: prolonged air leak, pneumonia, prolonged length of stay in the intensive care unit as well as an increased mortality rate which is influenced by the nature (elective vs non-elective) of the case. To reduce trauma to patients, transbronchial interventions are becoming increasingly popular. However, current techniques have only been demonstrated in humans for lung biopsy and often provide lesser quality specimens than SLB. Promising results have been achieved using cryotechnology but a standardized technique has yet to be established.

To demonstrate the potential for transbronchial interventions using cryo, we aim to develop a standardized technique for transbronchial cryobiopsy and cryoablation of pulmonary lesions using a human ex-vivo model.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing lung transplant surgery

Exclusion Criteria:

* Organ donor ineligible to donate lungs
* Healthy individuals
Development and Validation of a Disease Specific PROM to Assess Abdominal Involvement in Patients With CF (CFAbd-Score)

Development, validation and evaluation of a new multimodal questionnaire to assess and quantify the abdominal involvement in patients with the inherited life shortening multi-organ disease Cystic fibrosis.

In the stepwhise development of the patient reported outcome measures (PROM) repeadedly, CF-patients, their families as well as professionals working in different fields of CF-care will be included.

Development of a multimodal questionnaire considering the FDA guidelines for development of a PROM, the CFAbd-Score

* Evaluation of reliability of the questionnaire by examining internal consistency and construct validity
* Evaluation of reproducibility of the questionnaire by re-testing of patients
* Assessment of cross-generational applicability of the questionnaire by sub-scoring of age groups
* Evaluation of the responsiveness of the score by comparison with age-matched healthy controls
* Assessment of putative relationships of abdominal symptoms with faecal inflammatory markers
* Assessment of applicability of the questionnaire in other CF centers
* Transfer the CFAbd-Score to other countries and languages

Development and validation of a CF-specific tool for daily assessment of abdominal symptoms (patient diary), the CFAbd-day2day

Development and validation of a CF-specific tool for assessment of abdominal symptoms in children \< 12 years of age, the CFAbd-kid

Eligibility Criteria:
Inclusion Criteria:

CF cohort:

Diagnosis of CF determined by

* a sweat chloride of \>60 mEq/L and/or
* detection of 2 disease causing CFTR mutations with evidence of organ involvement.

Healthy controls:

* Age-matched

Exclusion Criteria:

CF cohort:

* Lacking ability to cooperate of patients /their families, respectively

Healthy controls:

* Other diseases causing abdominal symptoms (Inflammatory bowel disease (IBD), alpha 1 antitrypsin deficiency, celiac disease, food allergy, gastroenteritis, etc.)
Bright Light Therapy in Seasonal Affective Disorder (SAD)

Bright light therapy (BLT) is widely accepted as first-line treatment of seasonal affective disorder (SAD). However, the mechanism of action of BLT is still widely unknown. On the other hand, in mammals, light penetrates the skull bone and reaches the brain, and extra ocular transcranial phototransduction has physiological influences such as changed reproductive cycles and increased brain serotonin levels. Therefore, the investigators run a randomized, placebo controlled, double blind, dose finding study on the putative effect of transcranial bright light in the treatment of SAD.


Eligibility Criteria:
Inclusion Criteria:

• a patient has (according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision \[DSM-IV-TR\]) a Major depression, recurrent episode, seasonal pattern, "moderate" or "severe" (classification code 296.32 and 296.33)

The 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) score ≥ 20

* The 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) score ≥ 20
* The 21-item Hamilton Depression Rating Scale score ≥ 10
* The 8-item atypical symptom score ≥ 5

  * patient is over 18 years
  * patient can read and understand the subject information sheet
  * patient has signed the informed consent form
  * patient is not pregnant

Exclusion Criteria:

* patient has a lifetime psychotic disorder
* patient has a DSM-IV Axis I disorder other than some anxiety disorder evaluated by MINI
* patient has some DSM-IV-TR Axis II disorder, which is likely to interfere with the study treatment according to the investigator
* patient has alcohol or some other substance use dependence or misuse
* patients has some unstable somatic disorder
* patient uses some psychotropic agencies
* patient is, in the opinion of the investigator, unsuitable for any reason
* patient is a member of the site personnel or their immediate families
* patient has had bright light therapy via ear canals during the current episode
Analysis of Jumping in Patients With Ankle Instability (Ankle-optogait)

The study is, in accordance with current legislation, definable as a single-center interventional study with evaluations carried out at a single timeframe.

The objective of the study is to compare jumping performance between subjects with ankle instability and healthy volunteer subjects.

In particular, the primary objective is to verify the difference in the monopodalic CMJ value of the diseased limb of subjects with ankle instability compared to the control group at time 0.

The population is made up of patients suffering from ankle instability and a control group of healthy volunteers, divided as follows:

25 subjects GROUP A: Study group: patients suffering from ankle instability

25 subjects GROUP B: control group: healthy voluntary subjects not affected by ankle pathology

Ankle sprains are one of the most common injuries during sports activity which often results in chronic instability of the ankle, characterized by a feeling of sagging more or less associated with pain with impairment of sports activity.

Numerous authors have suggested that there is altered peripheral neuromuscular control in patients with ankle instability with limitations related to proprioception, neuromuscular control, or strength, leading to deficits not only of the ankle joint but of the entire inferior kinetic chain Jumping is a simple gesture, present in almost every sporting activity, and its evaluation has proven to be a reliable parameter in terms of partisan capacity.

Patients suffering from chronic ankle instability symptomatic of recurrent subjective and objective instability will be considered. Patients will be compared to a control group of healthy volunteer subjects.

T0

* Explanation of the study and written informed consent.
* Verification of inclusion/exclusion criteria and verification of previous or ongoing treatments.
* AOFAS Rating Scales,
* Tegner activity level
* Vertical Jump Test (CMJ) using OptoGait platform using a battery of monopodalic jumps.
* Drop jump using an OptoGait platform using a battery of monopodalic jumps
* Side hop test using an OptoGait platform using a battery of monopod jumps

Eligibility Criteria:
Inclusion Criteria:

* Athletes of legal age (aged between 18 and 45 years inclusive) suffering from chronic ankle instability symptomatic of recurrent subjective and objective instability (study group).
* Athletes of legal age (aged between 18 and 45 years) who are not symptomatic for ankle diseases (control group)
* Signing of the Informed Consent and consent to collaborate in all study procedures.

Exclusion Criteria:

* Minors
* Pregnant women (self-declaration)
* patients with BMI ≥ 30
* patients with orthopaedic, muscular and neuromuscular problems at the time of performing the jump
* Non-acceptance of informed consent
* Patients with previous unilateral or contralateral ankle reconstructive surgery
This Study in Healthy People Tests Whether Taking a Low Strength of Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills

The primary objective of this trial is to establish the bioequivalence of two empagliflozin/linagliptin/metformin extended release (XR) fixed dose combination (FDC) tablets (Test, T) compared with the same doses of the individual components given in separate tablets (Reference, R) when administered together after a high-fat, high-calorie meal.

The assessment of safety and tolerability will be the secondary objective of this trial.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (incl.)
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
* Female subjects of childbearing potential willing to use adequate contraception.
* Further inclusion criteria apply

Exclusion criteria:

* Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* Further exclusion criteria apply
Assessment of Awake Surgery With Electrocorticographic Recordings in the Management of Gliomas and Correlation With Imaging Data (ECoG)

This study proposes to analyze data from intraoperative ECoG recordings acquired during wakefulness interventions in order to identify the connection networks involved in cognitive functions. This study also proposes to correlate the ECoG data with the imaging data and to analyze the disturbances of the electrophysiological signals induced by the cortical and subcortical brain lesions: this will make it possible to establish a more detailed mapping of the tumor areas and to compare disturbances recorded to those recorded in healthy areas. Thus, this approach should make it possible to improve the quality of excision of glial lesions located in eloquent areas, while reducing the risk of neurological sequelae and thus improve the survival and quality of life of patients.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman over 18 years-old
* Subject with a non-recurrent glial lesion requiring surgery in vigilant condition;
* Brain lesion located in the functional zone;
* Major not protected within the meaning of the law;
* Subject affiliated to a Health Insurance scheme;
* No medical contraindication to performing an MRI (pacemaker);
* No medical contraindication to surgery and anesthesia;
* Karnofski index\> 70;
* Subject having signed an informed consent.

Exclusion Criteria:

* Minor subject, pregnant or breastfeeding woman;
* Major subject subject under measure of legal protection, guardianship or deprived of liberty by judicial or administrative decision;
* Subject hospitalized without consent;
* Subject treated with antipsychotics (neuroleptic or lithium);
* Subject who has already been treated for his glial lesion by surgery and / or radiotherapy;
* Subject refusing to sign an informed consent.
* Subject wishing to discontinue participation in the study before completion;
* Subject for which the surgical intervention and / or the ECoG recording could not be carried out after admission to the operating room (whatever the reason).