cyrilzakka/clinical-trials huggingface dataset:
Geographic Atrophy Treatment Evaluation

The purpose of this study was to evaluate the safety and efficacy of AL-8309B Ophthalmic Solution versus Vehicle administered as a topical ocular drop for the treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).


Eligibility Criteria:
Inclusion Criteria:

* Willing to give written informed consent, make required study visits, and follow instructions.
* Able to administer eye drops or have a caretaker to administer the eye drops.
* Study eye: Atrophy secondary to age-related macular degeneration, best corrected visual acuity (BCVA) of 35 letters (20/200 Snellen equivalent) or better, clear ocular media, and adequate pupillary dilation.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Pregnant, nursing, or not using adequate contraception.
* Ocular disease in the study eye, other than non-exudative AMD.
* History of cataract surgery in either eye within the past 3 months of screening.
* History or evidence of serious ocular trauma or intraocular surgery in either eye within the past 6 months of screening.
* Any medical condition that would make participation in the trial or adherence to the study schedule difficult or unlikely.
* Participation in an investigational drug or device study within 30 days of screening.
* Other protocol-defined exclusion criteria may apply.
Analysis of Genomic DNA Alterations in Familial Schizophrenia

Persons with schizophrenia experience imaginary voices, visions and disorganized thoughts, and are handicapped when it comes to social life, which is detrimental to the affected individuals and the community. Although the pathogenesis of this mental disease has not been clearly elucidated, much evidence suggests that inheritance is of major etiological importance and multiple genetic components are implicated. Previous linkage studies of familial schizophrenia have led to the successful identification of numerous susceptibility loci covering many of the human chromosomes, including chromosome 1q, 5q, 6p22, 6p24, 8q21, 13q32, 15q13-14 and 22q11, etc. Necessities for further identification of candidate genes involved in familial schizophrenia by taking a genome-wide approach are listed as follows:

1. given that multiple genes are responsible for this disease, it is of critical interest to view the complete molecular profiling of schizophrenia's genome;
2. identification of promising schizophrenia candidate genes by genome-wide scanning will facilitate the development of molecular markers and provide a more objective and effective assessment method in psychotic diagnosis and prognosis;
3. prevention of the onset of this disorder will be improved by early classification of individuals bearing strong genetic loading for schizophrenia as a high risk population;
4. making a breakthrough into the investigation of schizophrenia pathogenesis by the characterization of susceptible genes found by genome-wide exploring.

Array-based comparative genomic hybridization (CGH) allows high-throughput genome-wide survey for DNA copy number aberrations, providing a powerful tool for investigating genetic disorders and for developing diagnostic and therapeutic targets. Arrays used in this study consist of approximately 43,000 60-mer oligonucleotide probes that span coding and noncoding regions of the whole human genome with an average spatial resolution of around 35 kb. Furthermore, the sensitivity of these arrays is capable of detecting and mapping regions of single-copy losses, homozygous deletions, and amplicons of various sizes even when using full-complexity genomic samples. In this study, the investigators will conduct an array-based comparative genomic hybridization (CGH) with genomic DNA of many affected members from "schizophrenia families" (the investigators classified families according to the presence or absence of two or more affected members) to identify a set of candidate genes associated with this disease. It is hoped that the results obtained from this study will improve the accuracy and efficiency of psychotic treatment.


Eligibility Criteria:
Inclusion Criteria:

* Familial schizophrenia
* Over 9 years of education
Use of NAC in Prevention of Hangover Symptoms; Independent Alcohol Consumption Protocol

This is a double-blinded study involving healthy non-alcoholic (self-reported) volunteers over the age of 21. Consent is obtained prior to participation in the study while the participant is sober. Volunteers are recruited from residency programs, hospital employees, emergency medical personnel, and friends of the study investigators. If the volunteers choose to drink, they can participate in the study the night of ingestion of alcohol. There is no amount we ask them to drink, and we allow them to withdraw from the study at any time. We never force them to drink alcohol, or even encourage it. The participation is completely voluntary, if they would like to participate and if they choose to drink alcohol, we ask them to participate in the placebo controlled study in the safety of their own home. Then materials for the study are given out prior to their participation. An envelope is given with the questionnaire, and a small packet containing 3 pills of either NAC or placebo, and a small smear of Vicks vapor rub concealed in a small packet. At the end of their alcohol ingestion, the volunteer is asked to estimate the number roof drinks consumed and take 1 capsule per 3 drinks consumed of either 600 mg N-Acetyl-L-Cysteine or placebo capsules. In the morning, each participant fills out a Hangover Symptom Score questionnaire . A random number generator is used to determine placebo or NAC first, then the participant is given the other treatment at their subsequent encounter. Then study is being conducted over a series of many months, and data can be analyzed by the hangover symptoms scale data when using NAC compared to placebo. The data will be analyzed using the numerical values of each category for hangover classification and compare the placebo data to the control data.


Eligibility Criteria:
Inclusion Criteria:

* age over 21 years
* able and agrees to drink alcohol

Exclusion Criteria:

* alcoholism (self-reported)
* pregnancy
* reactive airway disease
* diabetes
* kidney/bladder stones
* kidney disease
* liver disease
* stomach ulcer
* organ transplant patients
* dialysis patients
* allergies to alcohol, eggs, milk, or wheat
* volunteers taking the following medications: opiate pain medication, activated charcoal, ampicillin,carbamazepine, cephalosporidine, methicillin, nitroglycerine, oxacillin, penicillin G, quinicillin
Effects of Pain Scrambler Therapy for the Alterations of Cerebral Blood

Prevalence of chronic pain has been shown to be high after thermal injury. Post-burn neuropathic pain causes chronic disabilities that is often difficult to treat effectively. Pain Scrambler therapy is a patient-specific electrocutaneous nerve stimulation device. To study changes in the pain network associated with neuropathic pain, magnetic resonance imaging(MRI) was used to evaluate cerebral blood volume(CBV) in patients who had been injuried by burn. Participants (N=40, experimental 20 and control group 20) comprised patients with neuropathic pain after thermal injury. The subjects complained of severe neuropathic pain that was rated at least 5 on the visual analogue scale (VAS), despite treatments with gabapentin medication and other physical modalities. Each Scrambler therapy with the MC5-A Calmare® therapy device (Competitive Technologies, Inc. Fairfield, USA ) was performed for 40 min daily (Monday through Friday) for 10 consecutive days. The stimulus was increased to the maximum intensity bearable by the individual patient without causing any additional pain or discomfort. The intensity of neuropathic pain was measured using the visual analogue scale(VAS). Depressive mood was assessed using the Beck Depression Scale. Voxel-wise comparisons of relative CBV maps were made between before scrambler therapy and after 10 scrambler therapy sessions over the entire brain volume. The relationship between individual participant CBV(measured in voxels), BDS and VAS score was also examined. We observed decreased in the cerebral pain network of patients with burn injury. Scrambler therapy is a non-invasive, non-medicinal modality that significantly reduced burn-associated neuropathic pain. Scrambler therapy should be considered as a treatment option for burn survivors with severe neuropathic pain.

The groups (scrambler therapy and sham therapy) were randomly assigned. All subjects were recruited in scrambler thrapy and sham stimulation. Main study outcomes included group differences in CBV changed and the the relationship between CBV changes and neuropathic pain intensity. These analyses were performed using the same framework of the general linear model, which was repeatedly applied to each voxel with the same coordinates.

Eligibility Criteria:
Inclusion Criteria:

* Burn patients
* severe neuropatic pain rated at least 5 on the 10-point numerical rating scale (NRS)

Exclusion Criteria:

* cardiac arrest history
* history of neurologi disease or brain surgery
* unstable heart disease or presence of a cardiac pacemaker
* pain resulting from other causes like as neuromuscular diseases
* psychiatric disorder
* diabetes mellitus
* abnormal renal function
* contraindication for MRI, or pregnancy.
Magnesium as an Adjunct for Pain Treatment After Surgery for Thumb Base Arthrosis

A randomised controlled trial of addition to the standard pain treatment of 1000 mg oral magnesium citrate or placebo for 7 Days during surgery for thumb base arthrosis. Intraoperative nociception will be measured with the NoL-index with a PM-200 machine.

Our hypothesis is that an addition of oral 1000 mg magnesium citrate daily for 7 Days starting at the day of the surgery will decrease the postoperative pain and improve the recovery after surgery. It will be given as an supplement to the regular pain treatment with acetaminophen and oxycodone that are used in our hospital and compared to a placebo. The choice of treatment will be blinded for the patient, the care providers and for the research team doing the evaluation.

The pain level will be collected Before surgery, postoperatively and at 14 Days after surgery and by a self reporting form during the first 7 Days. The patients will also report their recovery with a modified QoR-15 form. QoR-15 is validated in a Swedish version.

Magnesium is shown to reduce postoperative pain in some studies that used iv magnesium sulphate. For long lasting pain conditions oral magnesium is shown to improve the patients well being and decrease their pain in some conditions. Magnesium acts as a mild antagonist at the NMDA-receptor. Thus low levels of magnesium is thought to increase the risk of long lasting postoperative pain. Therefore there are reason to expect a higher dose of magnesium supplement decreases the long lasting post operative pain.

Eligibility Criteria:
Inclusion Criteria:

* Planned for surgery of thumb base arthrosis with trapeziectomy with ligament reconstruction tendon interposition.
* Age 18 years or older.
* low anesthetic risk, ASA class 1 or 2.
* Be able to take oral medication.
* Be able to read and communicate in Swedish.

Exclusion Criteria:

* Age under 18 years.
* Heartfailure, kidney failure, ischemic hearth disease.
* Previous neuropathic pain or complex pain syndrome.
* Serious psychiatric morbidity
* Not able to communicate in Swedish
* Skin problems that makes the application of NoL-sensor impossible.
Assignment of the Verbal Component Score and Addition of Pupil Reaction to the Glasgow Coma Scale

In this study, it is aimed to determine the prognostic value of GCS-P and the GCS-P score, which is formed by assigning a verbal score, in patients with traumatic brain injury, where all parameters can be evaluated. In the model to be created, a new total score will be obtained with Motor score + Eye Response + assigned verbal Score-Pupil score and this score will be compared with GCS and GCS-Pupil score.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to hospital due to traumatic brain injury,
* 18 years and older,
* who were alive at the time of admission,
* Patients whose GCS and pupil reactivity can be evaluated completely.

Exclusion Criteria:

* Younger than 18,
* Not alive at the time of admission,
* Patients whose GCS score and pupil reactivity are not correctly evaluated (facial trauma, past eye diseases or eye defects, etc.).
Long-term Cohort Study of Mesorectal Excision for Rectal Cancer

The aim of this cohort study is to record, evaluate and compare the surgical, oncological as well as the functional outcome and Quality of life after mesorectal excision for rectal cancer

Outcomes of mesorectal excision patients will be analysed. Medical records will be reviewed and perioperative outcomes retrieved, incl. long-term oncological and functional/quality of life data. A retrospective cohort over 10 years (2007-2016) will serve as a control to a prospective cohort over 10 further years (2017-2026) as to investigate trends in perioperative and oncological outcomes (min. follow-up of 5 years + adequate cohort size). Prospective data on bowel function, urogenital function and quality of life will measured at time of diagnosis and further. Variations in neoadjuvant/adjuvant treatment and surgical approaches will be assessed for their effect on the outcomes of interest.

Eligibility Criteria:
Inclusion Criteria:

* Men and Women \>18 years
* Patients with rectal cancer
* Underwent mesorectal excision
* Agreed to fill in a validated questionnaires before surgery and after stoma reversal
* Informed consent

Exclusion Criteria:

* Age \< 18
* No informed consent (no general consent, no consent to use personal data for research purpose)
The Sweet PEA Study: Effects of Diet During Pregnancy on Infant Growth and Development.

The purpose of the Sweet PEA Study is to determine whether diet during pregnancy has an effect on infant's growth, body composition, and brain development.

Rationale: Non-nutritive sweetener (NNS) consumption during pregnancy is prevalent, but effects on maternal and infant health are not well known. Intervention: None Objectives: To determine whether NNS consumption during pregnancy is associated with increased infant body fat, as well as differences in infant growth, brain structure/function, gut microbiota, and gestational diabetes. Study population: Women prior to 28 weeks' gestation, determined to have either low/no NNS consumption (control) or high NNS consumption (experimental), based on a pre-screening survey. Methodology: Identify two groups (low/high consumers) in early pregnancy, collect data during pregnancy remotely (telephone, internet, medical records) to determine diet and any link to pregnancy complications, have in-person visits with mothers/infants at 1, 6, and 12 months of age, collecting: body composition data (by EchoMRI), brain structure/connectivity (MRI), stool samples. Outcomes: Primary outcome is infant adiposity at 1, 6, and 12 months. Additional measures include infant growth, feeding behaviors, brain structure/ connectivity, gut microbiota, and maternal metabolic outcomes during routine gestational testing (fasting glucose, insulin, triglycerides, gestational diabetes diagnosis) Follow-up: This will operate as a small pilot study, and a larger study with more participants, a wider spectrum of NNS exposure, and longer follow up (into childhood and beyond) may follow. Statistics: Multivariate linear mixed effects examining maternal NNS intake and outcomes across time (repeated measures)

Eligibility Criteria:
Inclusion Criteria:

Mothers:

* Pregnant women prior to 28 weeks gestation
* Report the least NNS consumption of pre-screened participants (0 servings per week - representing the control group) and most NNS consumption of pre-screened participants (≥ 5 servings per week - representing the experimental group).
* 18-40 years of age
* Singleton pregnancy
* Be able/willing to understand the procedures of the study
* Be able to read English at a 5th grade level (materials also available in Spanish, if required)

Infants:

* Infant's mother must be enrolled in the study and provide infant assent to participate

Exclusion Criteria:

Mothers:

* Physician diagnosis of a major medical illness
* Pre-existing diabetes (type 1 or type 2), or GDM in a previous pregnancy
* Physical, mental, or cognitive issues preventing participation
* Medications that may affect body weight, body composition, insulin resistance, or lipid profiles
* Tobacco or drug use (any current use or quitting during pregnancy)
* Alcohol consumption during pregnancy (\>1 drink per week)

Infants:

* Presumed or known congenital birth defects
Nocturnal Blood Pressure - Central and Peripheral 24-h Blood Pressure in Chronic Kidney Disease.

A new study have shown that high nighttime blood pressure (BP) and/or non-dipping (lack of fall in blood pressure during nighttime) is a strong predictor for the risk of cardiovascular disease and mortality in patients with hypertension. Three factors seem to affect the night time blood pressure: chronic kidney disease, obstructive sleep apnea (OSA) or the way ambulatory blood pressure is monitored.

The aim of this study is to analyse the importance of these three factors on nighttime bloodpressure.

Hypothesis:

Central 24 hour blood pressure monitoring provides another measure of daily fluctuations in blood pressure than peripheral 24 hour blood pressure monitoring, because measurement is painless and does not interfere with activities during the daytime or night-time sleep

In chronic kidney disease and OSA the decrease in nocturnal BP is lower than in healthy subjects.

In chronic kidney disease the decrease in the nocturnal BP is inversely correlated to the severity of OSA, the severity of kidney disease, and blood pressure during daytime.

150 patients with chronic kidney disease (CKD III-IV) and 75 healthy subject is examined with both central and peripheral 24 hours blood pressure monitoring, 1 night home polygraphy to determine whether the subject has obstructive sleep apnea, and if so the degree (AHI), blood- and urine samples to determine levels of u-AQP2 og u-ENaCɣ, PRC, p-AngII, p-Aldosterone, p-Avp og p-Endothelin.

Eligibility Criteria:
Patients, group 1:

Inclusion Criteria:

* eGFR 15-59 mL/min/1.73 m2 (estimated GFR)
* 18-80 years
* males and females

Exclusion Criteria:

* lack of desire to participate
* treatment for OSA
* malignant disease
* Abuse of drugs or alcohol
* pregnant and lactating
* incompensated heart failure
* atrial fibrillation
* liver disease (ALAT\> 200)
* Severe chronic obstructive lung disease (forced expiratory volume in 1 second \<50% predicted)

Healthy Subjects:

inclusion criteria

* Healthy volunteers men and women
* age 40 - 80 years
* BMI within the normal range, ie. between 18.5 to 25.0 kg/m2

exclusion Criteria

* Arterial hypertension, ie. ambulatory blood pressure\> 130 mmHg systolic and / or 80 mmHg diastolic.
* a history or clinical signs of cardial, pulmonary, hepato, renal, endocrine, cerebral or neoplastic disorders
* Alcohol abuse, ie. \> 14 drinks / week for women and\> 21/uge for men
* Substance abuse
* Daily medicine intake/ treatment apart from oral contraceptives
* Smoking
* Pregnancy or breastfeeding
* Lack of desire to participate
* Clinically significant, discrepant results of blood or urine sample at inclusion study (ie B-hemoglobin and B-White blood cell count, p-Sodium, p-Potassium, p-creatinine, p-ALAT, p-bilirubin , p-alkaline phosphatase, p-cholesterol, p-albumin or b-glucose and urine for hematuria, albuminuria or glucosuria)
* Clinically significant differences in the electrocardiogram
* Blood Donation for the past month preceding the day on the first attempt sequence.
Non--operative Treatment of the Medial Malleolus in bi- and Trimalleolar Ankle Fractures

The purpose of this study was to determine if internal fixation of the medial malleolus is necessary following open reduction and internal fixation of the lateral and, if required, the posterior malleolus treating displaced bi-or trimalleolar ankle fractures.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Orthopaedic Trauma Association (OTA) type 44 fractures (B2-3 and C2-3).

Exclusion Criteria:

* Patients with OTA type 43 distal tibia fractures.
* Patients with soft tissue injuries involving the medial malleolus.
Centers for Education on Research and Therapeutics - Heart Failure: Targeted Intervention Study

The objective of this study is to evaluate whether a quarterly feedback, education and performance improvement site-based intervention has a greater impact on quality performance and adherence to evidenced-based guidelines than existing on-demand feedback. This study will use a randomized design to compare changes in quality performance and adherence to selected measures among hospitals using existing on-demand reports and general quality improvement (QI) efforts versus those receiving intensive, targeted QI feedback via reports, teleconferences, webinars, and specialized tool kits.


Eligibility Criteria:
Inclusion Criteria:

* All sites participating in Get With the Guidelines Heart Failure.

Exclusion Criteria:

* Sites in Get With the Guidelines Heart Failure which opt out of participation.