cyrilzakka/clinical-trials huggingface dataset:
West Nile Virus Seroprevalence Under Bird Ringers

In August 2020, West Nile Virus (WNV) was isolated from a live common whitethroat for the first time in The Netherlands. Follow-up sampling showed that the virus could also be detected in mosquitos from the same location during at least a whole month of sampling. On 15 October 2020, one case of West Nile virus infection has been reported in a man who was likely infected in the Utrecht region. This is the first time that a locally acquired human case of WNV infection has been reported in The Netherlands. Six additional cases have been identified, one of which from the region Arnhem. West Nile virus infection is a mosquito-borne zoonosis. The disease, which has spread across the Northern Hemisphere in the past three decades, is now found on an annual basis in many European countries where the centre of gravity lies in Southern-European countries. Recently, WNV was reported for the first time in Germany. The virus is transmitted among birds through the bite of infected mosquitoes and incidentally infects humans and other mammals, such as horses. Around 80% of human WNV infections are asymptomatic. The most common clinical presentation is West Nile fever but, older people and immunocompromised persons are at higher risk of developing neuro-invasive disorders (West Nile neuroinvasive disease). Currently, there are no prophylaxis or specific treatment against the disease in humans. In addition, Usutu virus (USUV) was detected in The Netherlands in 2016. USUV is another flavivirus, related to WNV, and also capable of infecting humans. Disease associated with USUV infection in humans appears to be milder and only limited number of cases have been identified. During their bird catching activities, bird ringers are intensively exposed to mosquito bites at the natural habitat of the birds and at the same time of the day when mosquitoes are particularly active. The aim of this study is therefore to determine the prevalence of WNV and USUV serum antibodies in bird ringers in The Netherlands.


Eligibility Criteria:
Inclusion Criteria:

* Carrying-out bird ringing activities during spring, summer or early autumn 2020 in The Netherlands

Exclusion Criteria:

* Not willing to participate in this study
* Using medication interfering with antibodies production
* Under 18 years of age
Hippotherapy Simulators on Trunk Control and Upper Extremity Functions in Cerebral Palsy

The hippotherapy simulator imitates the three-dimensional mechanical movement and walking of the horse and transfers the mechanical effect to the rider during hippotherapy. The aim of this study was to investigate the effect of exercise program with hippotherapy simulator on upper extremity functions and trunk control of individuals with cerebral palsy.All individuals diagnosed with Cerebral Palsy who agree to participate in the study and meet the inclusion criteria will be randomly divided into two groups as Study and Control Group. In addition to conventional physiotherapy, the study group will be trained in the Hippotherapy Simulature for 15 minutes a day, 5 days a week for 4 weeks.n addition to conventional physiotherapy, the control group will be allowed to sit in the Hippotherapy Simulature for 15 minutes a day, 5 days a week for 4 weeks. However, the simulator will be kept in closed position to prevent oscillations.

Cerebral Palsy can be defined as a non-progressive lesion that occurs in the brain that has not yet completed its development and causes activity limitation with movement and posture problems. Although the disorders seen in Cerebral Palsy are not progressive, these individuals may experience losses in their current motor functions in later ages and this may cause losses in their independence and activities of daily living. The hippotherapy simulator imitates the three-dimensional mechanical movement and walking of the horse and transfers the mechanical effect to the rider during hippotherapy. The aim of this study was to investigate the effect of exercise program with hippotherapy simulator on upper extremity functions and trunk control of individuals with cerebral palsy.All individuals diagnosed with Cerebral Palsy who agree to participate in the study and meet the inclusion criteria will be randomly divided into two groups as Study and Control Group. In addition to conventional physiotherapy, the study group will be trained in the Hippotherapy Simulature for 15 minutes a day, 5 days a week for 4 weeks.n addition to conventional physiotherapy, the control group will be allowed to sit in the Hippotherapy Simulature for 15 minutes a day, 5 days a week for 4 weeks. However, the simulator will be kept in closed position to prevent oscillations.

Eligibility Criteria:
Inclusion Criteria:

* Being between 6-18 years old
* Being diagnosed with unilateral spastic type cerebral palsy
* Voluntariness of the family and individuals to participate in the study
* Being at I, II, III level according to the Hand Skills Classification System
* To have the cognitive development to cooperate

Exclusion Criteria:

* Having undergone any orthopedic and/or neurological surgery and/or BoNT A operation within the last 6 months
* Having a history of epilepsy
* Hearing and/or vision loss at a level that prevents participation in the study
Impact of Protein Source on Gut Health

The gastrointestinal (GI) tract is a central hub for human health given its essential role in nutrient absorption, waste production and immunity. Diet is a major contributor to gut health including affecting the incidence and severity of GI disease. This is mediated, at least in part, by the presence of microbiota, a highly diet-dependent biome. In fact, dietary changes are capable of altering bacterial populations and/or microbial metabolism, which in turn, controls the type and abundance of small molecules being produced in the gut, many of which can exert biological effects. Several lines of evidence suggest that dietary protein in particular, can impact gut health. Therefore, this trial will test whether dietary protein type differentially impacts gut function in humans by carrying out a single-blinded randomized cross-over controlled feeding study in healthy individuals. Subjects will be provided with an individualized very low protein diet augmented with pea- or egg white-derived protein supplements, as their major protein source. The impact of consuming pea vs. egg white protein on 1) the fecal metabolome, 2) gut barrier function and 3) gastrointestinal symptoms will be determined.


Eligibility Criteria:
Inclusion Criteria:

* BMI of 18-29.9

Exclusion Criteria:

* Those with a history of significant illness including diabetes, renal, liver or cardiovascular disease, malnutrition, GI disease (including IBS, IBD, chronic constipation or diarrhea), mental illness (i.e. depression, bipolar disorder)
* Those adhering to a vegan diet or vegetarian diet exclusive of eggs
* Those having taken probiotics or antibiotics within 1 month of starting the study
* Those who are pregnant or plan to become pregnant
ssTAP vs TAP Catheters in TAH

Prospective, randomized study comparing local wound infiltration with local anesthetic (LA) versus single injection TAP blocks (ssTAP) with LA versus continuous TAP block (TAP caths) catheters with LA for treatment of postoperative pain after total abdominal hysterectomy (TAH).


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo total abdominal hysterectomy
* Age ≥ 18 years.
* American Society of Anesthesiologists (ASA) physical status ≤ 3

Exclusion Criteria:

* Known coagulopathy
* Known allergy to Bupivacaine or morphine
* Contraindication to Tylenol usage
* Medical conditions contraindicated to bupivacaine use
* Daily narcotic usage for ≥ 2 weeks of 20mg of oxycodone daily or an equivalent.
Long-Term Follow-up in Patients Included in the Meta-analysis "Sleep Apnea Syndrome and Arterial Stiffness"

The meta-analysis "sleep apnea syndrome and arterial stiffness" includes data from 893 patients initially included in 9 studies conducted by the EFCR Department of the CHUGA between 2006 and 2015, presenting a sleep apnea syndrome (SAS) with exploration of their arterial stiffness via the measurement of pulse wave velocity (PWV).

Currently, we do not have long-term follow-up data for these patients.

The first objective of the "PWV Follow-up" project is to collect cardiovascular events in these patients through telephone interviews and a structured questionnaire to determine the prevalence of these events. The prevalence of metabolic events, incident cancers and deaths will be also determined as secondary objectives through the same questionnaire.

Others secondary objectives are to evaluate the impact of continuous positive airway pressure (CPAP, the reference treatment for OSA) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.

The meta-analysis "sleep apnea syndrome and arterial stiffness" includes data from 893 patients initially included in 9 studies conducted by the EFCR Department of the CHUGA between 2006 and 2015, presenting a sleep apnea syndrome (SAS) with exploration of their arterial stiffness via the measurement of pulse wave velocity (PWV).

The 9 studies were referred as : ADISAS (NCT011968), AGIRSASADOM (NCT010902), BPCO (NCT004044), BPCO-SAS (NCT01195064), DIAMETASAS, Aortic Dissection (NCT01068691), INFRASAS (NCT010892), VALSAS (NCT004094), NIV-OHS (NCT006030).

The objective of this meta-analysis on individual data was to understand the relationship between the severity of the sleep apnea syndrome (measured by the apnea + hypopnea index) and arterial rigidity at the time of diagnosis of SAS.

Currently, we do not have long-term follow-up data for these patients.

The first objective of the "PWV Follow-up" project is to collect cardiovascular events in these patients through telephone interviews and a structured questionnaire to determine the prevalence of these events. The prevalence of metabolic events, incident cancers and deaths will be also determined as secondary objectives through the same questionnaire.

Others secondary objectives are to evaluate the impact of continuous positive airway pressure (CPAP, the reference treatment for OSA) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.

Eligibility Criteria:
Inclusion Criteria:

* already included in the meta-analysis "sleep apnea syndrome and arterial stiffness".

Exclusion Criteria:

* refusal to participate
* family not reachable and death not identified in the Hospital medical base
* persons under judicial protection (article L1122-2 of the Public Health Code) and patients under guardianship or curatorship
A Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg) - Positive Chronic Hepatitis B

This single-arm study will evaluate the efficacy and safety of peginterferon alfa-2a in treatment-naive Baltic participants with Hepatitis B envelope antigen (HBeAg)-positive chronic Hepatitis B virus (HBV). All participants will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneously once weekly. Following 48 weeks of treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is less than 100 participants.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, 18-70 years of age;
* HBeAg positive, Hepatitis B surface antigen (HBsAg) positive for greater than or equal to 6 months;
* anti-HBs negative;
* Hepatitis B virus deoxyribonucleic acid (HBV DNA) greater than 5,00,000 copies/milliliters.

Exclusion Criteria:

* Previous antiviral or interferon-based therapy for chronic hepatitis B;
* Evidence of decompensated liver disease;
* Chronic liver disease other than viral hepatitis;
* Co-infection with active hepatitis A, C or D virus;
* Co-infection with human immunodeficiency virus.
Open-Label Phase III Long-Term Safety Trial of Liprotamase

This is an open-label, single-arm clinical study investigating the long-term safety of ALTU-135 treatment in patients with cystic fibrosis (CF)-related exocrine pancreatic insufficiency (PI).


Eligibility Criteria:
Inclusion Criteria

* Females of childbearing potential must be willing to use birth control
* Diagnosis of CF based upon the following criteria:

  * Two clinical features consistent with CF; and either
  * A genotype with two identifiable mutations consistent with CF, or
  * Sweat chloride \> 60 milliequivalents per liter (mEq/L) by quantitative pilocarpine iontophoresis.
* Clinically stable with no evidence of acute upper or lower respiratory tract infection
* Exocrine pancreatic insufficiency (PI) determined by fecal elastase \< 100 micrograms per gram (µg/g) measured at Screening
* Able to take pancreatic enzyme supplementation in the form of capsules
* Able to perform the testing and procedures required for this study, as judged by the Investigator

Exclusion Criteria:

* Age \<7 years
* Pregnancy, breastfeeding or of childbearing potential and not willing to use birth control
* Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to Screening
* History of fibrosing colonopathy
* History of liver transplant, lung transplant or significant surgical resection of the bowel
* Any chronic diarrheal illness unrelated to PI
* Abnormal liver function (except for patients with Gilbert Syndrome)
* Signs and/or symptoms of liver cirrhosis or portal hypertension (e.g., splenomegaly, ascites, esophageal varices), or documented liver disease unrelated to CF
* Unable to discontinue enteral tube feedings during the study
* Any condition that the Investigator believes would interfere with the intent of this study or would make participation not in the best interest of the patient
* Baseline coefficient of fat absorption (CFA) ≥ 93% from the Phase III efficacy study
* Patient is unlikely to complete the study, as determined by the Investigator
The Influence of Fat Perception on Satiety From Consumption of Reduced Fat Snacks

The present study aims to investigate the effect of fat level and fat type of a snack on self-reported satiety and associated biomarkers. The relevant individual differences will also be investigated.

The aims are: (1) To determine whether reducing fat in a snack leads to rebound hunger and higher food intake at the subsequent meal, (2)To determine whether a low fat snack product matched for expected satiety leads to differences in post-ingestive satiety (i.e. mouth-gut discordance), (2) To determine whether individual differences in sensory perception influence expected or post-ingestive satiety.

Stage 1, Characterising Volunteers:

Fat is perceived through three sensory modalities; mouthfeel, taste and odour. Humans vary in their perception of fat across all sensory modalities. Volunteers will be characterised on their ability to taste fatty acids and perceive mouthfeel.

Stage 2, Establish Sensory Tolerance in Expected Satiety of a fat reduced snack model:

Reduced fat products are typically reformulated to match the perceived texture and mouthfeel of the original product. This stage aims to quantify sensory tolerance to fat reduction.

Stage 3, Establish Mouth Gut Discordance of a fat reduced snack model:

Using a standard preload study design, and the same fat-emulsion snack model from stage 2, the investigators will contrast effects of 3 test samples in a balanced cross-over design.

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Aged 18-70 years
* Body mass index (BMI): 18-32 kg/m2
* Fasting glucose \< 7 mmol/l
* Fasting total cholesterol \< 7.5 mmol/L
* Fasting triglycerides \< 2.3 mmol/L
* Weight stable in the last three months

Exclusion Criteria:

* Diagnosed with diabetes or cardiovascular disease (e.g. stroke or heart attack), gastrointestinal (e.g. Irritable bowel syndrome (IBS), inflammatory conditions, gastroenteritis), endocrine or renal diseases
* Smoker
* Taking prescribed medications that could influence study outcomes (e.g. lipid lowering medications, anti-depressants, anticoagulants)
* Food allergies (e.g. gluten, dairy) and intolerances (e.g. lactose)
* Drug abuse
* Anaemia (men: haemoglobin\<130 g/L and women \<115 g/L)
* Hypertension (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg)
* Planning or currently on a weight reducing programme
* Pregnancy, planned pregnancy in the next year or lactating
* Currently taking part or participation in other research studies within the last three months
Trial of Void With Saline Bladder Instillation

This study is being done to see if there is a difference between the traditional method of removing a urethral catheter after surgery and waiting for the patient to urinate on their own to the saline instillation method which places either room temperature or warmed saline into the patient's bladder through the catheter before removing the catheter.

Voiding trials after surgery to remove a catheter can be done in different ways.

Traditional method: The catheter is removed and the patient will attempt to void.

Room temperature saline instillation: Room temperature saline will be placed in the patients bladder through the catheter. The catheter will be removed and the patient will attempt to void.

Warmed saline group: Saline that has been warmed to 37C will be placed in the patients bladder through the catheter. The catheter will be removed and the patient will attempt to void.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing trial of void after placement of indwelling urethral catheter after urologic procedure

Exclusion Criteria:

* Patient incontinent at baseline.
* Patient has chronic indwelling urinary catheter or uses clean intermittent catheterization at home.
* Patient has documented neurogenic bladder.
* No trained person to administer the instillation or perform consent.
* Patient refusal to participate.
* Patient unable to give informed consent.
* Patient is a prisoner.
* Patient is pregnant.
* Patient unable to participate in notifying nursing of voids.
* Nursing is unable to measure post void residual with bladder scan machine secondary to body habitus or other anatomical abnormality.
Prediction of Thyroid Cancer From Ultrasonographic Characteristics of Thyroid Nodules

The aim of this study is to identify which ultrasonographic feature or a combination of features is the best predictor of thyroid cancer in thyroid nodules.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with thyroid nodules over 10 mm in the longest diameter
* Euthyroid or hypothyroid subjects with a solitary thyroid nodule or multinodular goiter
* Subjects with a hypoactive nodule in the thyroid scan and a low TSH

Exclusion Criteria:

* Subjects with four or more thyroid nodules that are over 10 mm
* Subjects with low TSH and hyperactive nodule on thyroid scan
CPAP for Esophageal Cancer With Radiotherapy

The goal of this clinical trial is to test the use of CPAP in patients with esophgaeal cancer undergoing radiotherapy.

The main questions it aims to answer are:

* does use of CPAP decrease exposure of normal lung to radiation?
* does use of CPAP decrease exposure of normal heart to radiation?

Participants will undergo simulation twice:

* with CPAP
* without CPAP


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of cancer, with a tumor (primary or secondary) in the esophagus including tumors in the esophagus-stomach junction.
2. Age ≥ 18
3. Planned RT treatment
4. The level of functioning ≥ 60 on the Karnofsky scale
5. Life expectancy ≥ two months
6. All patients must understand the informed consent form document and sign it of their own free will before any test/procedure related to the study is performed.
7. Able to undergo simulation and radiation with CPAP
8. Candidate patients can be recruited to receive definitive, palliative or pre-operative radiation, with or without chemotherapy.

Exclusion Criteria:

A person who meets any of the following exclusion criteria will not be able to participate in the study:

1. Pregnancy or breastfeeding
2. Significant comorbidity at the starting point that would prevent the use of CPAP
3. Hospitalized in an institution by virtue of an administrative order or a court order.
4. Special population
5. A history of a psychiatric problem that may impair the patient's ability to understand the research requirements or respond to them, or to give his consent
Impact of Bariatric Surgery on Heart Disease Compared to Standard Care

Obesity is associated with type 2 diabetes (T2D) and cardiovascular disease (CVD). Metabolic and bariatric surgery (MBS) has in several randomized controlled trials (RCT) been shown to be superior to best medical therapy in the treatment of T2D. In the area of CVD, RCT after MBS are lacking. It was recently demonstrated in a cohort study that MBS in patients with severe obesity and a previous myocardial infarction (MI) was associated with a 50% reduction in the risk of death and new MI. The aim of this proposal is to confirm this in a nationwide RCT. Using the nationwide SWEDEHEART database patients with severe obesity and a previous MI will be identified. They will be contacted and offered participation. After informed consent the patients will be randomized to MBS or optimized care (including visit with a cardiologist and optimization of secondary preventive measures and referral to dietician/physiotherapist). The primary outcome measure is a major cardiovascular adverse event (MACE). Secondary outcome measures include mortality, new MI, stroke, heart failure and atrial fibrillation. Tertiary outcome measures include health related quality of life and surgical complications. Patients will be followed in the nationwide metabolic surgery register SOReg, the national inpatient register, national cause of death register, the Swedish prescribed drug register, and the Swedish population register. If positive results these can be included in guidelines for MBS.


Eligibility Criteria:
Inclusion Criteria:

* MI (as defined by the universal definition of MI) at least 1 year before inclusion.
* BMI ≥35 kg/m2
* Written informed consent obtained

Exclusion Criteria:

* Any condition that may influence the patient's ability to comply with study protocol.
* Earlier MBS or operation for gastric or duodenal ulcer or reflux disease
* Other condition that makes patient not suitable for MBS according to responsible surgeon and anesthesiologist
* Unable to understand Swedish.
Evaluation of the Safety and the Efficacy of Transanal TME in Difficult Cases

The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision in difficult case.

Difficult case is defined as below;

- If any one of the following (1 or 2 or 3)

1. BMI: 30 or more
2. Tumor size: more than 7cm in long diameter
3. CRM: mesorectal fascia involvement or less than 1 mm on MRI

Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.

Eligibility Criteria:
Inclusion Criteria:

* age: 20-80 years
* biopsy-proven adenocarcinoma of the rectum
* clinical staging (c or yc): T0-3, N0-2, M0
* Rectal cancer located 3-12 cm from the anal verge
* ECOG performance status: 2 or less
* If any one of the following (1 or 2 or 3)

  1. BMI: 30 or more
  2. Tumor size: more than 7cm in long diameter
  3. CRM: mesorectal fascia involvement or less than 1 mm on MRI

Exclusion Criteria:

* Synchronous colon cancer or other malignancy
* Obstructing rectal cancer
* Pregnant or breast-feeding
* Receiving any other study agents
* Fecal incontinence
* History of prior colorectal cancer or inflammatory bowel disease