cyrilzakka/clinical-trials huggingface dataset:
Alzheimers Disease and Neuromarkers in Patients With Acute Hip Fractures

The investigators explore the presence of AD factors beta-amyloid and tau in CSF and plasma to verify AD diagnosis in patients with acute hip fracture. Clinical dementia test is performed prior to operation. Blood samples and CSF samples are collected at surgery and blood samples are collected postoperatively at intervals. Mortality is assessed at 30 days, 3 months and 1 year. Morbidity is assessed at , 3 months and \>1 year. Neuromarkers specifically addressing the inflammatory component are to be analyzed and correlated to outcome together with AD markers, as above.

The hypotheses explored in this investigation is that patients being pre-AD or having AD have worse prognosis following an acute hip fracture. This has been demonstrated in retrospective studies. In this study we admit all patients with a hip fracture planned tro receive a spinal anesthesia. Our golden standard of anesthesia in this patient cohort. Preoperatively Clinical Dementia Score is assessed after study inclosure. At the performance of the spinal dosage is standardized. Prior to giving this 5 ml of CSF is collected and blood is collected. Blood is then collected at intervals up until day 3 postoperatively. We plan to analyze beta-amyloid and tau in CSF and plasma to verify AD diagnosis in patients with acute hip fracture. Mortality is assessed at 30 days, 3 months and 1 year. Morbidity is assessed at, 3 months and \>1 year. Neuromarkers specifically addressing the inflammatory component are to be analyzed and correlated to outcome together with AD markers, as above.

Eligibility Criteria:
Inclusion Criteria:

* Hip fracture with a planed spinal anesthesia

Exclusion Criteria:

* Not receiving a spinal anesthesia i.e. no CSF is available
A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method

The proposed study is a multi-centre, open-label crossover study to assess the safety and acceptability of a silicone elastomer vaginal ring (containing no drug) when inserted for a 12 week period in 200 healthy, sexually active women.


Eligibility Criteria:
Inclusion Criteria:

* Female, age 18-35 years
* Willing and able to provide written informed consent
* HIV-uninfected and otherwise healthy
* Self-reported sexually active
* On a stable hormonal contraceptive regimen
* Regular menstrual cycle
* Willing to refrain from use of vaginal products or objects during the study

Exclusion Criteria:

* Currently pregnant or last pregnancy within 3 months prior to enrollment
* Currently breast-feeding
* Participated in any other research study within 30 days prior to enrollment;
* Symptomatic untreated vaginal infections within 2 weeks prior to enrollment
* Presence of abnormal physical finding on the vulva, vaginal walls or cervix
* History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction;
* Pap smear result at screening that requires cryotherapy, biopsy, treatment (other than for infection), or further evaluation
* Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynecologic surgery within 90 days prior to enrollment
* Any serious acute, chronic or progressive disease
The Predictive Value of Amniotic Fluid pH and Electrolytes on Neonatal Respiratory Disorders

Amniotic fluid (AF) is a complex structure with a changing content by gestational time. AF pH can be affected by both maternal and fetal conditions such as preterm ruptures of membranes, prematurity and fetal distress. While fetal urine is the major content of AF since 20th gestational week, fetal lung liquid (FLL) also acts as a minor content. Secretion of FLL depends on chloride transport and postnatal clearance of FLL is provided by active reabsorption of sodium (Na) ions. Down-regulation of epithelial Na channels (ENaCs) and an increase of pulmonary compliance accompany to pulmonary adaptation developing at the first hours of life. Lower genomic expression of Na channels in airways is shown to be associated to respiratory distress syndrome (RDS) in preterm. Although pH and electrolyte value of AF is thought to be relevant to fetal and maternal conditions such as gestational age, antenatal steroids and preterm birth, there is no study about this topic in the literature.


Eligibility Criteria:
Inclusion Criteria:

Accepted to participate with informed consent Normal healthy pregnancies

Exclusion Criteria:

Congenital abnormalities Chromosomal abnormalities Blood contaminated AF Declined to participate
To Study the Effectiveness and Safety of Niacin and a Topical Steroid Eye Drop to Treat Retinal Vein Occlusions

The purpose of this study is to determine whether Niacin, a B vitamin, may act as a vasodilator to encourage earlier formation of collateral blood vessels that may serve to bypass the obstructed vein in the eye. The topical steroid eye drops are aimed at reducing swelling in the retina, until the collateral vessels have a chance to develop.

The aim of this study is to develop a less risky, yet effective and more sustainable treatment for retinal vein occlusions than the current commonly used approach of repeated intravitreal triamcinolone acetonide (Kenalog) injections. The types of retinal vein occlusion that are being studied include central (CRVO), hemi-retinal (HRVO), and branch (BRVO) retinal vein occlusion. Niacin, (Nicotinic Acid, not Nicotinamide)a B-vitamin, has lipid lowering and vasodilating properties. The combination of Niacin and Prednisolone Acetate steroid eye drops as a non-invasive treatment approach was developed by the Principal Investigator. The Niacin dilates the retinal vessels, hopefully encouraging earlier collateral vessel formation aimed at bypassing the venous obstruction, thus restoring venous outflow. The Prednisolone Acetate steroid eye drops are aimed at reducing vascular leakage and therefore the macular edema in the eye while the Niacin is taking effect.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be able to understand the study procedures, agree to participate, and give written consent.
* Patient must have central retinal vein occlusion, hemi-retinal vein occlusion or branch retinal vein occlusion.
* Patients must be able to follow the study medication regimen.
* Patients must agree to return for the once monthly eye exams.
* Patients must agree to have liver function tests performed on a regular basis.
* Patients must agree to have regular appointments with their Internist on an established basis.

Exclusion Criteria:

* Patients with active Gout, or high levels of Uric
* Patients may not be pregnant or lactating.
* The Principal Investigator reserves the right to exclude any patient who he feels will not make a good candidate.
Evaluation of the Follow Me Mode of the AutoLap System - A Feasibility Study

The main objectives of this study are to evaluate the performance and ease of use of the Follow me mode of the AutoLap system during general and gynecological laparoscopic procedures.


Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated Informed Consent Form (ICF).
2. Patients over 18 years

Exclusion Criteria:

1. Pregnancy
2. Extensive adhesions that will preclude routine laparoscopic surgical approach.
3. American Society of Anesthesiologists' (ASA) classification\>2
Comparing Mirror Therapy Rehabilitation Device to Conventional Mirror Therapy

This is a randomized controlled trial which will compare conventional mirror therapy with mirror therapy using the Miraπ device which physically moves a patient's affected limb.

This study will use two parallel groups: (1) receiving conventional mirror therapy as a part of the standard of care as conducted by the participant's clinical care team and (2) receiving mirror therapy with the Miraπ device as conducted by study personnel with the oversight of the participant's clinical care team.


Eligibility Criteria:
Inclusion Criteria:

* Participants currently accepted and cleared for rehabilitation in the inpatient rehabilitation unit by the rehabilitation medical director.
* Participants with paralysis or motor function problems of only one hand.
* Participants need mirror therapy because of their health condition.
* Participants' rehabilitation physician determined that mirror therapy would be appropriate for standard of care.
* Participants are able to memorize easy tasks, and able to follow instructions e.g., moving the healthy fingers.

Exclusion Criteria:

* Participants who are not cleared physically or medically to participate in standard acute inpatient rehabilitation therapies by the rehabilitation medical director
* Participants who are not able to memorize easy tasks, e.g., moving the healthy fingers.
* Participants with spasticity of the affected hand (as assed by the occupational therapist)
* Minors
* Vulnerable populations
Characterization and Functionality of Calcium Channels Cav1.4 of Th17 Lymphocytes in Human With Psoriasis

It's clearly known that lymphocyte activation in particular Th17 response, plays a major role in the development of plaque psoriasis. New therapies targeting this pathway are showing great clinical efficacy in patients with moderate to severe plaque psoriasis.

Pioneering observations have shown that the expression of Cav1.4 channels in Th17 lymphocytes and they're functional role is supported by the inhibition of IL-17 production by a pharmacological inhibitor of Cav1 channels that is effective in a mouse model of Psoriasis.

This data strongly suggest that the Cav1.4 channel, via its involvement in the signalling responsible for the production of Th17 cytokines represents an interesting therapeutic target in Psoriasis.

The aim of the study is to explore biological functions related to the activation of the Cav1.4 pathway in Psoriasis.

* Evaluate the expression of Cav1.4 calcium channels by Th17 lymphocytes from plaque psoriasis.
* To assess:

  * The role of Cav1.4 channels on the activation of Th17 lymphocytes
  * The transcriptomic signature relating to the signalling channel Cav1.4
  * The epigenetic signature, in particular changes in overall methylation and specific promoter methylation

Eligibility Criteria:
Inclusion Criteria:

* Group 1 : Subject with plaque psoriasis (diagnosis confirmed by dermatologist) with a plaque IGA score ≥ 3
* Group 2 : Subject with atopic dermatitis according to the UK Working party criteria with an IGA plaque score ≥3

Exlusion Criteria:

* Group 1 : Other chronic inflammatory dermatosis than plaque psoriasis at the sites to be sampled
* Group 2 : Other chronic inflammatory dermatosis than Atopic Dermatitis at the sites to be sampled
* For both groups: Ongoing treatment with calcium channel blockers
* For both groups: Any current topical treatment on the biopsied or systemic plaque for psoriasis or AD (including phototherapy)
Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone Under Fasting Conditions in Healthy Volunteers

The purpose of this study is to assess the safety and bioequivalence of a single oral dose of carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa combination plus a single oral dose of entacapone under fasting conditions in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects age 18 to 55 years of age included, and in good health
* At Screening, and Baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed after the subject has rested for at least five (5) minutes, and again when required after three (3) minutes in the standing position. Vital signs should be within the normal ranges
* Body mass index (BMI) within the range of 18 to 27 and weigh at least 50 kg
* Female subjects must have undergone hysterectomy, or must be postmenopausal.

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
* History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
* Receiving monoamine oxidase (MAO) inhibitors within 28 days prior to the first dose
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
* History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.
* Significant illness within two weeks prior to dosing
* Subjects who, through completion of the study, would have donated in excess of: 500 mL of blood in 14 days; 1500 mL of blood in 180 days; 2500 mL of blood in 1 year.
* History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
* History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
* Women of child bearing potential ( WOCBP)
* History or presence of glaucoma or any suspicious undiagnosed skin lesions

Other protocol-defined inclusion/exclusion criteria may apply
Ultrasonographic Predictors of Hypotension After Induction

The purpose of the study is to evaluate the predictive value of the inferior vena cava collapsibility index and caval aorta index for detecting hypotension after induction of general anesthesia.

Since cardiovascular depressant and vasodilatory effects of anesthetic agents, patients may be at risk of hypotension after induction of general anesthesia. Previous studies reported that, for evaluating volume status, some ultrasonographic measurements such as inferior vena cava collapsibility index (IVCCI) could be used. Also some studies stated that measurement of aorta diameter index (IVC : Ao index) is reliable to predict hypotension after induction of spinal anesthesia. At the study, the investigators aimed to investigate the predictive values of the inferior vena cava collapsibility index and caval aorta index under ultrasound guidance in predicting post-induction hypotension in patients under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* patients more than 18 years of age
* American Society of Anesthesiologists' (ASA) physical status 1 or 2

Exclusion Criteria:

* BMI more than 30 kg/m²
* Use of angiotensin converting enzyme inhibitors
* pregnancy,
* emergency operations
* baseline arterial systolic blood pressure less than 90 mmHg
* mean arterial blood pressure less than 70 mmHg
Assessment of Zinc Absorption From a Phytic Acid Rich Complementary Food

Assessment of zinc absorption from a phytic acid rich complementary food, consumed by young children immediately after the addition of the enzyme phytase. A randomized single blind study


Eligibility Criteria:
Inclusion Criteria:

1. 12-24 month old
2. Male of female
3. Height and weight between -2.0 SD and +2.0 SD with respect to WHO child growth standards.
4. No mineral and vitamin supplements 2 weeks prior to the study and during the whole duration of the study

Exclusion Criteria:

1. Body temperature ≥ 37.5°C
2. Hemoglobin ≤ 7g/dL
3. Positive RDT test
4. Any metabolic, gastrointestinal or chronic disease (according to the statement of the subject's parent) known chronic diseases at the gastrointestinal tract)
5. Long term mediation (that may affect zinc metabolism) during the whole study to interact with zinc metabolism (such as kidney diseases or
Hyperlactatemia During and After Tumorcraniotomy

This study aims to investigate the association between hyperlactatemia and neurological disability, length-of-stay and mortality in patients who undergo tumorcraniotomy. The risk factors that induce lactat accumulation will also be explored.

Hyperlactatemia is a frequent occurrence in brain tumor surgery. The existing studies, however, are all retrospective, reporting varying effects on clinical outcome. One study reported new neurological deficitis, some found an association with extended hospital stay, while others found no association with outcome. It is therefore important to conduct a prospective study of hyperlactatemia in this patientgroup.

Participants in this study will follow the standard treatment protocol for tumorcraniotomy, aside from 2-3 additional, perioperative blodgas analyses and 2 standardized measurements of neurological disability.

Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years
* Must undergo elective tumor craniotomy
* Understand oral and written Danish

Exclusion Criteria:

* Adults with incapacity
* Stereotactic biopsy
* Lack of informed and signed consent to participate in study
Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 1

This study is to examine if inhaled doses of menthol that produce low and high cooling effects change the appeal of e-cigarettes containing low and high doses of nicotine in adolescent smokers. The hypothesis is that the combination of nicotine and menthol, when compared with menthol or nicotine alone, will result in greater increase in liking of an e-cigarette and greater reduction in nicotine withdrawal.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-20 years
* Able to read and write
* Cigarette smoker
* Use of e-cigarettes in the past 30 days

Exclusion Criteria:

* Seeking smoking cessation treatment
* Current/lifetime criteria for dependence on another psychoactive substance -Daily use of alcohol or marijuana or use of any other drugs including cocaine, opiates, stimulants
* Regular use of psychoactive drugs including anxiolytics, antidepressants and other psychostimulants
* Current or past history of psychosis or other psychiatric diagnosis such as major depression
* Any significant current medical condition
Impact of Associated Abdominal Injuries on Clinical and Operative Outcome in Pelvic Injuries

Pelvic fractures are severe injuries which require advanced orthopedic surgical skills to treat. On the other hand, abdominal injuries are severe injuries, which might require quick general surgical treatment. The combination of both injuries is a challenge for orthopedic surgeons, as the abdominal injury might lead to a delayed surgical treatment of the pelvic fracture. Whether an associated abdominal injury influences the quality of care of pelvic fractures, is aim of this registry study.

The German Pelvic Registry of the German Trauma Society is a multicenter prospective registry which collects data of patients with pelvic injuries since 2003. Beside demographic data (including concomitant injuries) allowing for epidemiological evaluations of the development of surgical care in these patients, namely the operative care is focus of this registry. Beside the chosen procedure or surgical approach, this includes both intraoperative data like time until operation, duration of the procedure or intraoperative blood loss and reduction parameters (pre- and postoperative fracture steps). The clinical course is recorded also including overall morbidity, overall mortality and osteosynthesis-related complications.

The influence of a concomitant abdominal trauma on the quality of care regarding operative parameters like reduction quality or the clinical course in pelvic injuries has not been investigated yet.

The investigators therefore retrospectively analyze the prospective consecutive data of patients from the multicenter German Pelvic Registry of the German Trauma Society in the years 2003 - 2017. Demographic, clinical and operative parameter were recorded and compared in two groups (isolated pelvic fracture vs. combined abdominal/pelvic trauma).

Eligibility Criteria:
Inclusion Criteria:

* Pelvic fracture

Exclusion Criteria:

* no agreement to participate in the registry
A Multicenter Patient Registry on Outcomes From Cryoanalgesia of the Intercostal Nerves

This is a retrospective and prospective, multicenter, observational patient registry to record outcomes from patients undergoing cryoablation of the intercostal nerves (cryoanalgesia) for post-operative pain management.


Eligibility Criteria:
Inclusion Criteria:

1. Patients whose age is 12 years or above, and are able to give informed consent/assent specific to state and national law.
2. Patients have been scheduled by physician(s) to undergo or have undergone cryoablation of the intercostal nerves utilizing at least one AtriCure device or are similar patients treated without the use of cryoablation

Exclusion Criteria:

1. Patient is enrolled in a concurrent trial that may impact the treatment offered by the registry devices.
2. Patient with exclusion criteria required by local governance.
3. Women of childbearing potential who are, or plan to become, pregnant during the time of the study
The Treatment Effectiveness of Combined tDCs and Neurofeedback (NF) for Patients With Cognitive Deficits After Stroke

This is a double blinded, randomized control trial with a pretest-posttest control and interventional groups design. Both the assessor and participants are blinded to all assessments and evaluations. All patients with subacute stroke undergo in-patient or out-patient rehabilitation are screened initially by a series of screening test. Suitable patients are assigned randomly to 3 groups respectively. Group 1 is the combined transcranial direct current stimulation (tDCS) and neurofeedback group. Group 2 is the neurofeedback group. Group 3 is the control group with sham neurofeedback training.

Treatment sessions for all three groups are conducted by the investigators who has training in neurofeedback and transcranial direct current stimulation (tDCs). Each participant performed 10 training sessions on different days. Sessions were conducted 3-5 times a week The tDCS + neurofeedback group will carry out 30 minutes tDCS and 30 minutes neurofeedback training.

The real neurofeedback group will carry out 30 minutes neurofeedback training. The sham neurofeedback group will conduct the 30 minutes sham neurofeedback training.

Eligibility Criteria:
Inclusion Criteria:

1. First or second stroke (haemorrhagic or ischaemic) confirmed by computer axial tomography scan or magnetic resonance imaging
2. Below 16 th percentile cut off in Hong Kong Montreal - Cognitive Assessment (HK - MoCA) (range from 17-25/30).
3. Less than twelve months since onset of stroke at study entry
4. Able to follow simple command

Exclusion Criteria:

1. Patients with severe dysphasia (either expressive or comprehensive) which restricts communication;
2. History of other neurological disease, psychiatric disorder, or alcoholism;
3. Significant impairment in visual or auditory function
4. Any additional medical or psychological condition that would affect their ability to comply with the study protocol.