cyrilzakka/clinical-trials huggingface dataset:
Study of Cerebral Function in Patients With Chronic Hepatitis C Infection (HCV/CNS)

Patients with HCV infection often suffer from chronic fatigue, depression and reduced cognition, even before evolving severe liver fibrosis, liver cirrhosis and hepatic encephalopathy.

It is currently unclear to what extent the symptoms er due to a direct pathological effects of the virus itself, or due to pre-existing psychiatric disease. There is a complex relationship between prior or existing drug abuse, psychiatric disease and HCV infection, that makes it difficult to establish cause-effect relationships.

A biological mechanism has been suggested to contribute to development of cerebral dysfunction in the patients. According to the prevailing Trojan Horses hypothesis circulating lymphocytes cross the blood brain barrier carrying HCV to the central nervous system and virus is subsequently replicated in the macrophages and the microglia in brain as a separate compartment. As part of the immunological response to viral replication, neurodegenerative processes takes place with a harmful effect on the neural circuit and cerebral function. Identification of HCV RNA negative strand, a replication product, in brain tissue from HCV patients, as part of autopsy studies, supports the hypothesis. Moreover, HCV patients have also been observed with abnormal metabolic concentrations in the frontal white substance and the basal ganglia by MRI spectroscopy compared to control groups.

The overall study objective is to assess cerebral function with particular emphasis on cognitive functions in HCV patients (genotypes 1,2,3 and 4) by use of a neuropsychiatric test battery. Furthermore, the patients will be examined by MRI, including magnetization transfer, diffusion tensor and contrast perfusion, in order to perform measurements of cerebral volumetric and microstructure. Finally, HCV analysis, including viral sequences and cytokine profiles, in serum and cerebrospinal fluid will be carried out in the study population.


Eligibility Criteria:
Inclusion Criteria:

* Chronic HCV infection with genotype 1, 2, 3 or 4.
* Age \> 18 and \<60
* Liver biopsy or fibroscan performed within last 5 years
* Signed informed consent form.

Exclusion Criteria:

* Liver biopsy showing liver pathology not due to HCV infection.
* Liver cirrhosis or severe liver fibrosis
* Former antiviral HCV treatment (for included HCV patients).
* HIV and/or Hepatitis B virus infection.
* Alcohol or drug abuse within the last 2 years.
* Neutropenia, anemia or thrombocytopenia.
* Clinical signs of non-compensated liver pathology.
* Moderate to severe cardiopulmonary disease (NYHA score 1 or above)
* Creatinine clearance \< 80mL/min.
* Pregnancy.
* Ferromagnetic implants
* Significant somatic disease affecting the central nervous system (somatic/neurologic disease)
* Head trauma resulting in unconsciousness \> 5min
* Schizophrenia or other psychotic disorders
Bioavailability of BIBR 953 ZW After Dose of BIBR 1048 MS

To assess the extent of absorption of 12.5, 50 and 200 mg of BIBR 1048 MS with and without coadministration of 150 mg ranitidine.


Eligibility Criteria:
Inclusion Criteria:

* healthy male subjects as determined by results of screening
* signed written informed consent in accordance with GCP and local legislation
* age \>= 18 and \<= 50 years
* Broca \>= - 20% and \<0 + 20%

Exclusion Criteria:

* any finding of the medical examination (including blood pressure, pulse rate and ECG)
* history or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
* history of orthostatic hypotension, fainting spells and blackouts
* diseases of central nervous system (such as epilepsy) or psychiatric disorders
* chronic or relevant acute infections
* History of:

  * allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  * any bleeding disorder including prolonged or habitual bleeding
  * other hematologic disease
  * cerebral bleeding (e.g. after a car accident)
  * commotio cerebri
* intake of drugs with a long half-life (\>24 hours) within 1 month prior to administration
* use of any drugs which might influence the results of the trial within 10 days prior to administration or during administration
* participation in another trial with an investigational drug within 2 month prior to administration or during trial
* smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
* alcohol abuse (\>60 g / day)
* drug abuse
* blood donation within 1 month prior to administration or during the trial
* excessive physical activities within 5 days prior to administration or during the trial
* any laboratory value outside the clinically accepted reference range
* history of any familial bleeding disorder
* Thrombocytes \< 150000 /µl
Comparing the Alignment Efficiency of Three Types of Nickel-titanium Archwires

To compare the alignment efficiency of conventional NiTi arch wire to Thermal and Super elastic NiTi arch wires.

Method: All the participants will be recruited from Ziauddin University dental OPD, each will be provided with full information about study. An informed consent form will be signed from every patient or their guardian/parents. Patients who agree to be part of this study will be included.

Subjects will be treated by Orthodontic resident under faculty supervision. Pre-treatment mandibular crowding will be assessed on dental casts. Randomization of the three groups will be done by "Opaque envelope technique" Bonding will be done using 3M uniteck brackets. After initial bonding good quality mandibular impressions will be taken and poured to obtain dental casts. Impressions and casts will be obtained at every 4 weeks interval until the initial alignment phase is complete. At the time of bonding all lower anterior teeth will be fully engaged in the archwire. The principal researcher will tag every model with an identification code before calculating measurements.

The contact point displacements will be measured with vernier caliper using the Little's index of irregularity. All measurements will be then summed and aggregated value will represent the degree of anterior irregularities.

Eligibility Criteria:
Inclusion Criteria:

* lower anterior crowding good oral hygeine all permanent lower incisors no previous orthodontic treatment

Exclusion Criteria:

* extracted or missing lower incisors poor oral hygeine relevant medical history previous orthodontic treatment
The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery

PKAZ is a single institution study designed to evaluate the optimal dosing parameters for azithromycin for pre-surgical cesarean prophylaxis.

Hypothesis: Pre-operative administration of azithromycin results in maternal and neonatal tissue concentrations that adequately treat microbes commonly involved in post-cesarean infections.


Eligibility Criteria:
Inclusion Criteria:

* Women 19 years and older
* Term (37 weeks and greater)
* Singleton gestation
* Scheduled cesarean section
* Non-laboring
* Intact membranes

Exclusion Criteria:

* \< 19 years of age
* Preterm (\< 37 weeks)
* Multifetal gestation
* Laboring or ruptured membranes
* Known fetal anomaly
* Oligo- or polyhydramnios
* Macrolide allergy
* Macrolide exposure within 2 weeks
* Medical co-morbidities
* Hepatic or renal impairment
* Taking medications that prolong the QT interval
* Currently taking nelfinavir, efavirenz, or flucanozole
* Structural heart defects or arrythmia
Effect Alveolar Recruitment Manoeuver on Stroke Volume a Randomized Study

Objective: to compare the effect of alveolar recruitment manouver through stepwise increase and decrease in airway pressure or sustained 30 secondes 30 cmH2O continuous positive airway pressure on cardiac stroke volume estimated by oesophageal doppler in preload independent anesthetized patients scheduled for surgery.

Following anesthesia and preload optimisation guided by cardiac stroke volume, patients will be randomised to one alveolr recruitment manoeuver :

* stepwise increase and decrease in positive airway pressure
* sustained 30 secondes 30 cmH2O continuous positive airway pressure The primary objective is the change in cardiac stroke volume.

Eligibility Criteria:
Inclusion Criteria:

* adult patients scheduled for major surgery requiring hemodynamic monitoring
* written signed informed consent

Exclusion Criteria:

* pregnancy
* non sinusal heart rate
* known cardiac right ventricular failure or arterial pulmonary hypertension
* pneumothorax
* known pulmonary emphysema
N-3 Fatty Acid Requirements for Human Development

Polyunsaturated fatty acids known as n-3 fatty acids are essential dietary nutrients for humans, and are known to be important to reducing the risk of certain diseases, particularly those related to neural system, cardiovascular system and immune system. Among the different n-3 fatty acids, docosahexaenoic acid (DHA) is present in particularly high amounts in the brain and retina, and is accumulated in large amounts in these organs during the last trimester of fetal development and first few months after birth. The n-3 fatty acids are present in the diet as linolenic acid which is found in vegetable and seed oils, and as DHA which is only found in animal tissue fats, with fatty fish being the richest dietary source. Humans are able to convert linolenic acid to DHA, but the conversion is believed to be slow in human and possibly inadequate to support the needs for DHA for the developing brain. Information from our work and those of others has suggested that DHA is important during pregnancy, however specific evidence is lacking to show that the DHA status of pregnant women in low, or that improvement in the DHA status of Canadian women during pregnancy will have benefit to early infant an child development. There is no evidence that infants of vegans and vegetarians, or women who do not eat DHA are at risk for developmental delays. The purpose of this study is to investigate whether a dietary supplement of DHA during pregnancy has any effect on infant birth weight, or indices of infant growth, visual, mental and motor skill development.

This is a randomized, blinded prospective study with 2 groups: placebo and group supplemented with DHA. Women are randomized at 16 weeks gestation without knowledge of their dietary fatty acid intake. Only healthy women expecting to deliver a single infant with no known or anticipated maternal or fetal complications are enrolled. Maternal venous blood is collected at 16 and 36 weeks of gestation and used to assess the maternal DHA status and effect of DHA supplementation. Dietary information is collected at 16 and 36 weeks of gestation to determine usual fatty acid intakes. Following delivery, fetal cord blood is collected to assess transfer of DHA from mother to fetus. Breast milk samples are collected from all breast feeding mothers at 1 and 2 months postpartum. The mother -infant pairs are followed for 18 months. Measures include visual acuity, language, motor and mental development, and growth and dietary intakes.

Eligibility Criteria:
Inclusion Criteria:

* 12-16 weeks gestation
* Low risk pregnancy
* Expected to deliver single full term
* No maternal metabolic or infectious disease
* No known fetal complications.
Subclavian Versus Inferior Vena Cava Collapsibility Indices.

Traditional methods for intravascular volume status assessment include physical examination, raised leg test, central venous pressure (CVP) and pulmonary artery catheters occlusion pressure (PAWP). Central venous pressure and pulmonary artery occlusion pressure are invasive and associated with significant complications. More recently, a number of less invasive techniques have been introduced, but they lack standardization and reliability. Ultrasonically, inferior vena cava collapsibility can detect hypovolemia non-invasively.

The aim of this study is that measurement of subclavian vein collapsibility index(SCV-CI) could be potential adjunct to IVC-CI where the IVC visualization is impaired or not possible .

-Finding a non-invasive reliable accurate method for evaluation of intravascular volume and response to volume resuscitation.

Eligibility Criteria:
Inclusion Criteria:

* 1. American society of anaesthesiologists physical status grade I and grade II .

  2. Elective laparotomy. 3. Supine position

Exclusion Criteria:

1. Patient refusal .
2. Portal hypertension .
3. Severe peripheral vascular diseases.
4. Obstructive lung diseases .
5. Right sided heart failure , arrhythmia and valvular heart heart diseases .
6. Body mass index \>35 kg/m2
Women In Steady Exercise Research - Window of Opportunity for Exercise and Tumor Biology

The primary aim is to examine changes in tumor perfusion, oxygen saturation, and tumor physiology before and following acute physical activity in breast cancer patients.

The secondary aim is to examine changes in circulating tumor DNA (ctDNA) levels before and following acute physical activity in breast cancer patients.

The tertiary aim is to explore changes in circulating exerkines (cytokines and growth factors altered by exercise) before and following acute physical activity in breast cancer patients.

The proposed study seeks to leverage acute exercise physiology as a tool to better understand multiple clinical and mechanistic issues in exercise oncology. An acute exercise bout causes functional changes such as increases in heart rate and stroke volume leading to increased cardiac output and increased systemic blood flow. These systemic effects also increase tumor blood flow (perfusion). Additionally, an increase in mean arterial pressure increases oxygen diffusion distance within the tumor. Further, acute exercise mobilizes NK cells, cytokine signaling, and a myriad of other molecular and cellular transducers of exercise. Our study of acute exercise physiology in breast cancer patients will address several significant knowledge gaps both clinically and mechanistically.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed breast cancer patients
* Breast tumor is more than 2 cm (T2)
* With or without lymph node involvement (N0-3)
* With or without metastases (M0-M1)
* No initiation of neoadjuvant treatment
* Pre-surgical breast resection

Exclusion Criteria:

* Current use of anticoagulants, including Vitamin K antagonists (e.g. Warfarin), Direct Oral Anticoagulants (DOACs) (e.g. Pradaxa, Eliquis, Xarelto, Bevyxxa, Savaysa), low molecular weight heparins (LMWH), Fragmin, Lovenox, heparin.
* Body weight \<100 lbs
* Tis, T0, T1
* Started neoadjuvant therapy
* Absolute contraindications for exercise stress testing by self-report:

  * acute myocardial infarction (3-5 days)
  * unstable angina
  * uncontrolled arrhythmias causing symptoms or hemodynamic compromise
  * syncope
  * acute endocarditis
  * acute myocarditis or pericarditis
  * uncontrolled heart failure
  * acute pulmonary embolus or pulmonary infarction
  * thrombosis of lower extremities
  * suspected dissecting aneurysm
  * uncontrolled asthma
  * pulmonary edema
  * room air desaturation at rest ≤85%
  * respiratory failure
  * acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
  * mental impairment leading to inability to cooperate
  * decisional impairment
* Non-English speaking
* Pregnant women
* Children
Evaluation of Efficacy and Safety of Specific Immunotherapy With Modified Allergen Extracts of House Dust Mites

The objective of this study is to evaluate the efficacy and safety of specific subcutaneous immunotherapy with modified allergen extracts.


Eligibility Criteria:
Inclusion Criteria:

* Positive history of perennial allergic rhinitis due to house dust mites
* Positive screening skin prick test (wheal diameter \> 3 mm)
* Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
* Signed and dated patient´s Informed Consent,

Exclusion Criteria:

* Previous immunotherapy with mite extracts within the last 3 years,
* Simultaneous participation in other clinical trials,
* Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
* Auto-immune disorders,
* Severe chronic inflammatory diseases,
* Malignancy,
* Alcohol abuse,
* Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
* Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.
Efficacy and Safety of Lanreotide Autogel (ATG) in Combination With Temozolomide in Subjects With Thoracic Neuroendocrine Tumors.

The purpose of the protocol is to evaluate the efficacy and safety of Lanreotide ATG 120 mg in combination with Temozolomide in subjects with unresectable advanced neuroendocrine tumours of the lung or thymus as Disease Control Rate at 9 months.


Eligibility Criteria:
Inclusion Criteria:

* Histological documented unresectable advanced (locally or metastatic) well or moderately differentiated neuroendocrine tumors of the lung or thymus (typical and atypical carcinoids according to the World Health Organisation (WHO) 2004 criteria);
* Imaging documented progression within 12 months before screening visit (V1), according to RECIST criteria v 1.1;
* Measurable disease, as defined by RECIST criteria v 1.1, on a CT scan performed at screening visit (V1);
* Octreoscan or Ga68-DOTA-TATE/TOC/NOC-PET-TC within 12 months before screening visit (V1);
* Adequate liver, renal and bone marrow function.

Exclusion Criteria:

* Poorly differentiated neuroendocrine carcinoma and mixed Neuroendocrine tumours (NET), according to WHO 2004 criteria
* Neuroendocrine tumours other than lung or thymus
* Non-neuroendocrine thymic neoplasm
* Received a prior therapy with Peptide Receptor Radionuclide Therapy (PRRT) within 6 months prior to screening visit (V1)
* Treated with systemic therapies (chemotherapy, interferon-alpha, somatostatin analogues, molecular target therapies) within 1 month prior to screening visit (V1)
* Treated with a number of systemic therapy lines \> 3 prior to screening visit (V1), and any of the following:

  1. for chemotherapy no more than 1 line prior to V1
  2. for somatostatin analogue no more than 1 line therapy, considered as treatment lasting more than 6 months, prior to V1 no therapy with Temozolomide (TMZ) prior to V1
  3. Received a prior therapy with Peptide Receptor Radionuclide Therapy (PRRT) within 6 months prior to screening visit (V1)
* Received external palliative radiotherapy within the last 28 days prior to screening visit (V1)
* Received locoregional therapies (Transarterial embolization, Transcatheter arterial chemoembolization, thermo-ablation with radio-frequency) and Selective internal radiotherapy within 3 months prior to screening visit (V1)
* Presence of symptomatic brain metastasis
* Subjects with symptomatic cholelithiasis at screening visit (V1)
A Study to Evaluate the DePuy Minimally Invasive Unicompartmental Knee

The primary purpose of this investigation is to evaluate the surgical performance of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee and Instrumentation in a Multi-centre setting.

The secondary objective of this investigation is to evaluate the long-term survivorship of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee.

Primary endpoint - to demonstrate the suitability of the developed instrumentation to safely and accurately implant the preservation Unicompartmental Knee using postoperative radiographic limb and component alignment data.

Secondary endpoints - to demonstrate the survivorship and performance of the Preservation Unicompartmental Knee using the American Knee Society clinical and radiological assessment, Oxford Knee Score and survivorship analysis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, who are 40 to 75 years of age inclusive.
* Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom written consent has been obtained.
* Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
* Subjects who exhibit loss of articular cartilage which is predominantly confined to a single compartment. The remaining compartments must be intact and able to bear normal loads.
* Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the investigation device, according to the indications specified in the package insert leaflet.

Exclusion Criteria:

* Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
* Subjects with a known history of poor compliance to medical treatment.
* Women who are pregnant.
* Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
* Subjects who have participated in a clinical study with an investigational product in the last month.
* Subjects who are currently involved in any injury litigation claims.
* Revision of an existing unicompartmental implant.
* Subjects who have gross ligament laxity / instability.
* Subjects who have an inflammatory joint disease
* Subjects in whom there is evidence of previous joint sepsis
* Subjects who have a pre-operative flexion contracture of 15° or greater
* Subjects who have a pre-operative flexion of less than 90°
* Subjects who have a pre-operative limb deformity of greater than 15° varus or valgus
* Subjects who have morbid obesity i.e. BMI \> 40%
Development of Diagnostics and Treatment of Urological Cancers

The purpose of the study is to evaluate whether state-of-the-art technologies such and next generation sequencing and drug sensitivity and resistance testing of patient derived tumour tissue can facilitate research translation and improve outcome of urologic cancers.

Access to high-quality clinical patient material (e.g. tissue of primary tumor and metastasis, plasma and urine) linked to comprehensive registry and clinical data and molecular characterization of the patient material using state-of-the-art technologies (e.g. NGS, transcriptomics, imaging, DSRT) will facilitate a more rapid translation of basic research innovations into clinical care (diagnostics, imaging, therapeutics) and result in improved outcome of patients suffering from urologic cancers ("personalized medicine").

The principal aim of the project is to establish a framework and infrastructure for the systematic collection and interpretation of biological patient samples. Similarly, the investigators aim to establish the format how the related clinical and research data can be made readily accessible for both clinicians and researchers without compromising patient privacy. The key objectives of the project are to facilitate research translation and to improve outcome of urologic cancers.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is able to provide written informed consent and is at least 18 years of age
2. The patient must have a verified diagnosis of an urologic cancer by a board-certified clinician

Exclusion Criteria:

1. The patient is not willing to provide a written informed consent
2. The patient has a severe psychiatric illness, imprisonment or mental impairment inflicting on ability to give informed consent