cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess How the Drug Moves Through the Body, Adverse Events, and Tolerability of Oral ABBV-722 Capsules of Single and Multiple Ascending Doses in Adult Participants and Single Doses in Adult Asian Participants

This is a Phase 1, first-in-human study to investigate safety, tolerability, and pharmacokinetics of ABBV-722 after oral dosing in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Laboratory values meet the criteria specified in the protocol.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).
* Part 2 only: Healthy Han Chinese and Japanese individuals between 18 and 65 years of age, inclusive at the time of Screening.

  * Participant must be first- or second-generation Han Chinese of full Chinese parentage (both parents of Han Chinese descent), residing outside of China. Participants must be in general good health and maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.
  * First-generation participants will have been born in China to two parents and four grandparents, who were also born in China, and are of full Chinese descent.
  * Second-generation participants born outside of China must have two parents and four grandparents born in China and are of full Chinese descent. OR
  * Participant must be first- or second-generation Japanese of full Japanese parentage (both parents of Japanese descent), residing outside of Japan. Participants must be in general good health and maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.
  * First-generation participants will have been born in Japan to two parents and four grandparents, who were also born in Japan, and are of full Japanese descent.
  * Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan and are of full Japanese descent.

Exclusion Criteria:

* History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
* Consumption of alcohol, grapefruit products, Seville oranges, starfruit products or quinine/tonic water within the 72-hour period prior to study drug administration.
* Use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug.
Guadecitabine Extension Study

This is a multicenter, open-label extension study for participants who participated in a previous Astex-sponsored guadecitabine clinical study \[including but not limited to SGI-110-01 (NCT01261312), SGI-110-04 (NCT02348489), SGI-110-06 (NCT02920008), and SGI-110-07 (NCT02907359)\].

Participants who were still receiving treatment with guadecitabine and in the opinion of the investigator were still benefitting from treatment at the time of database close of the original study will be eligible to participate in this extension study. Approximately 250 subjects could be enrolled.

Participants will attend clinic visits on Days 1-5 of each 28-day cycle to receive treatment with guadecitabine. Data collection will be limited to treatment exposure, adverse events, concomitant medications, limited laboratory parameters, and survival status.

Eligibility Criteria:
Inclusion Criteria:

1. Previous participation in an Astex-sponsored guadecitabine clinical trial \[including but not limited to SGI-110-01 (NCT01261312), SGI-110-04 (NCT03603964), SGI-110-05, SGI-110-06 (NCT02920008), and SGI-110-07 (NCT02907359)\], in which the participant was treated with guadecitabine and was still on active treatment with guadecitabine at the time of database close for the prior study.
2. Participant is considered to be benefitting from guadecitabine treatment in the opinion of the treating investigator.
3. Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent before any study-specific procedure.
4. Women of child-bearing potential (according to recommendations of the Clinical Trial Facilitation Group \[CTFG\]) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of child-bearing potential and men with female partners of child-bearing potential must agree to practice 2 highly effective contraceptive measures while receiving treatment with guadecitabine and for at least 3 months after completing treatment and must agree not to become pregnant or father a child while receiving study treatment and for at least 3 months after completing guadecitabine treatment.

Exclusion Criteria:

* 1. Any participant who, in the opinion of the investigator, may have other conditions, organ dysfunction, or have safety data from their prior study participation that suggest that the risks of continuing treatment with guadecitabine may outweigh the benefits.
Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use

This retrospective study aims to assess the economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI and alpha-blocker (AB) combination therapy. Both the Integrated Health Care Information Solutions and PharMetrics databases will be utilized for this study (2000-2007).


Eligibility Criteria:
Inclusion Criteria:

* Male patients aged 50 years or older
* a medical claim of EP
* a prescription claim for a 5ARI and AB (provided both are within 180 days of index date)
* continuously eligible for 6 months prior to and at least 12 months after index prescription date.

Exclusion Criteria:

* diagnosis of prostate or bladder cancer
* any prostate-related surgical procedure within 5 months of index date
* prescription claim for finasteride indicative of male pattern baldness
* 5ARI therapy initiated prior to initiating AB therapy
Correlating MicroRNA Changes With Sepsis Outcomes

This trial studies how changes in microRNAs may correlate with sepsis outcomes. Sepsis is a type of severe infection of the blood stream, and its diagnosis may be obscured by many other conditions such as surgery, trauma, and cancer. MicroRNAs are biomarkers found in the blood and tissue. Blood samples may help correlate changes in microRNA expression to patient reactions to a sepsis infection.

PRIMARY OBJECTIVES:

I. To examine whether the cellular and viral micro ribonucleic acid (miRNA) changes in plasma and peripheral mononuclear blood cells (PMNCs) correlate with the diagnosis and outcome of sepsis.

SECONDARY OBJECTIVES:

I. To distinguish systemic inflammatory response syndrome (SIRS) without infection from sepsis and septic shock.

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP A: Patients undergo blood specimen collection at baseline (before surgery), the day after surgery, either the day of hospital discharge or the day of sepsis diagnosis, and 6 days after the baseline blood draw if still hospitalized.

GROUP B: Patients undergo blood specimen collection at baseline (day of sepsis diagnosis), the day after baseline, and on day 7 from baseline if still hospitalized.

Eligibility Criteria:
Inclusion Criteria:

* Electively scheduled for surgical operation that require general anesthesia and expected duration of hospitalization of longer than one day (for patients in Perioperative Evaluation \& Management \[POEM\]) or high clinical suspicion of sepsis by the emergency physician (for patients in emergency center)
* Ability to give informed consent. If the patient is incapacitated and unable to give informed consent, the next-of-kin or a person who has the power of attorney must be present for informed consent.
* For patients in the emergency center only, two or more of the following SIRS criteria:

  * Leukocytes \> 12,000/mm\^3 or \< 4,000/mm\^3 or \> 10% immature (band) forms, provided that no filgrastim or pegfilgrastim was administered within 30 days and no leukemia
  * Heart rate \> 90 beats/minute (min)
  * Respiratory rate \> 20 breaths/min or partial pressure of carbon dioxide (CO2) \< 32 mmHg
  * Oral temperature \> 38 degrees Celsius (C) or \< 36 degrees C or axillary temperature \> 37 degrees C or \< 35 degrees C

Exclusion Criteria:

* Inability to give informed consent or a person who has power of attorney for medical decision is not available
* Being moribund (for patients in emergency center) or cancellation of surgery (for patients in POEM)
* Active "Do Not Resuscitate" or "Do Not Intubate" order
BFR Therapy Following DRF

This study's goal is to evaluate whether blood flow restriction supplemented therapy is a superior therapy compared to traditional standard of care while recovering from a surgery that repairs distal radius fractures. In order to measure this, subjects will be randomly assigned to either the traditional therapy group (with standard of care) or a blood flow restriction supplemented therapy group. All patients involved in this study will have had a distal radius fracture that is repaired with a technique called volar plating and the procedure will be done via an open technique. All subjects will be asked to fill out questionnaires that assess their pain and wrist functionality throughout the course of the study. These measurements will help understand whether the supplemented therapy is effective at reducing pain and improving functionality for patients who are recovering from this injury.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients undergoing distal radius fracture open reduction internal fixation using volar plating (CPT 25607, 25608, and 25609)
* Age 50 - 75
* Fall onto outstretched hand injury

Exclusion Criteria:

* High energy mechanism

  * Fall from an elevated position greater than 12 inches
  * Motor vehicle collision
  * Any activity involving a powered vehicle (scooter, car, truck, ATV, motorcycle, tractor, etc.)
* any concomitant injury to the affected limb
* Bilateral distal radius fracture
* Revision procedures
* Worker's compensation status
* Non-English speaking
* No Internet Access
* Inability to provide informed consent
* Patients with known lymphovascular disorders, including peripheral arterial disease (PAD), prior deep vein thrombosis (DVT) or chronic lymphedema
* Patients with known genetic or other hypercoagulability disorders including those on long-term anticoagulation or anti-platelet therapy (other than prophylactic aspirin)
* Uncontrolled hypertension
* Patients with dialysis catheters or AV fistula
* Any other medical condition that affects the risk profile of the patient or that affects the normal physiologic function of the circulatory system of the extremities, based on sole discretion and medical judgement of the Primary Investigator
A Pilot Study Evaluating the Immunologic Status of Patients With HER2+ Breast Cancer

This is a pilot study to gather preliminary data on the baseline immunologic status of patients with HER-2(+) breast cancer and to establish an immune monitoring laboratory for future clinical trial.

This is a pilot study to gather preliminary data on the baseline immunologic status of patients with HER-2(+) breast cancer and to establish an immune monitoring laboratory for future clinical trial. We will ask up to 10 patients with HER-2(+) breast cancer in stable condition and in reasonable health to participate in this study. The study will establish an immune monitoring for correlative studies done in patients with HER-2(+) breast cancer. The immunologic tests that will be done are ELISpot, lymphocyte proliferation, intracellular cytokine staining, lymphocyte immunophenotyping, and ELISA.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years of age
* Histologically documented breast cancer (hormone receptor (ER/PR) status may be either positive or negative) with or without metastatic disease.
* HER-2(+) as determined by one of the following measurements. NOTE: HER-2(+) assessment may have been on initial diagnosis and need not be repeated for metastatic lesions

  * Immunohistochemistry (IHC) 3+, or
  * FISH + (HER-2 gene signal to centromere 17 signal \>2)
* No transfusion dependent patients and no transfusion within 30 days of leukopheresis
* Documented labs within 7 days of donation consisting of:

  * WBC \> 4.0 K/ul \& \< 11.0 K/ul
  * platelet count \> 150,000/mm3
  * hemoglobin \> 11.0 g/dl.
  * Hematocrit \> 33 %
* Weight \> 110 lbs
* No blood donation in last 8 weeks (blood samples taken for standard of care less then 30 cc/week are acceptable)
* Patients must not have active or unresolved infection.
* No cold or flu sympton at time of donation
* No prior myocardial infarction or active cardiac disease (e.g. congestive heart failure, clinically significant cardiac valvular disease or arrhythmia requiring medications, angina pectoris, uncontrolled hypertension, clinically significant pericardial effusion)
* All patients must give signed written informed consent.
* ECOG Performance Score of 0 or 1.
* Women of childbearing potential must have a negative serum or urine pregnancy test

Exclusion Criteria:

* The presence of another active malignancy
* Pregnant, lactating, or nursing
* Patients with prior myocardial infarction or active cardiac disease (e.g. congestive heart failure, clinically significant cardiac valvular disease or arrhythmia requiring medications, angina pectoris, uncontrolled hypertension, clinically significant pericardial effusion)
The Effects of tDCS Combined With Balance Training on Postural Control in Chronic Stroke Patients

Purpose:

The incidence of stroke in low-to-middle income countries is increasing .Balance impairment and falling negatively impact function of stroke patients. Mobility is based on successful postural control and about 30% of individuals with stroke are unable to ambulate without assistance.Transcranial direct current stimulation (tDCS) is a new promising tool for motor recovery in neurological disease.This can be addressed through a tDCS intervention.

Objective:The objectives of this study is to examine the efficacy of anodal tDCS combined with Biodex balance training on postural control in chronic stroke patients using laboratory and clinical assessments. The following essential treatment components; a) active tDCS stimulation paired with Biodex balance training, b)sham tDCS paired with Biodex balance training program.

To identify combinations effects of tDCS stimulation plus balance training . Hypothesis: Anodal tDCS targeting leg motor area (CZ) for 5-days plus Biodex balance training, will significantly improve stroke clients' balance and functional mobility.

Double blinded sham -controlled randomized tDCS stimulation Arms Assigned Interventions

Experimental: Arm 1

tDCS brain stimulation and simultaneous balance training

Participants underwent Active tDCS brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days.

No Intervention: Arm 2 Sham tDCS brain stimulation (20 minutes) and simultaneous balance training

Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days, All outcome measures will be measured in 4 time points: pre-test, post-test after 10 sessions of intervention, and after 1 week and 1 months post intervention as follow ups.

Eligibility Criteria:
Inclusion Criteria:

age ≥18 years; first-ever ischemic stroke; chronic phase of recovery (\>6 months); ability to walk 6- meter supported or unsupported; ability to stand at least unsupported for 40-seconds with eyes closed; only ischemic stroke involving middle cerebral artery (MCA) territory confirmed by CT or MRI.

Exclusion Criteria:

Use of any neuro- or psycho-active medications that alters balance; any other neurological conditions or sensory disorders affecting postural control; such as brain tumor, or substance abuse; orthopedic diseases; ongoing/recent (within 3 months) balance rehabilitation.
Investigation of the Effect of Vitamin K3-lotion for the Treatment of Cetuximab Induced Folliculitis

The study aims to explore the benefit of topical vitamin K3 lotion for the reactivation/rephosphorylation of EGF-receptor in the skin and the possible reduction in cutaneous side effects of EGFr-inhibition.

Primary aim: The possible reduction of cutaneous side effects: folliculitis, dryness and redness of the skin.

Secondary aim: To explore any possible side effects of topical vitamin K3 lotion.

Methods: 36 patients with metastatic colorectal cancer or metastatic head and neck cancer allocated to treatment with chemotherapy and biweekly cetuximab. Two equally sized areas of at least 10x10 cm on the back or chest of the patient is marked. Patients receive in a double blinded procedure placebo lotion on one side and vitamin K3 lotion on the other side. The treatment may last for a maximum of two months and the patients are followed biweekly with photos, VAS-scores, questionnaires and CTCAE estimations. The patient will be able to take weekly photos at home during the weeks they are not seen at the outpatient clinic. During the treatment all other skin products or antibiotics is allowed and will be carefully registered by the health care professionals in the outpatient clinic.

The patient may enter the trial in two different ways: 18 patients start treatment with study lotions at the time they start treatment with cetuximab. The other 18 patients start treatment with study lotions when folliculitis appears.

Patients are asked for 1.5 mm skin biopsies of both study areas of the skin before start of treatment and after 4 weeks of treatment with placebo lotion and vitamin K3 lotion. These biopsies will be investigated for EGFr, phosphorylated EGFr and other central downstream mechanisms. The biopsy part of the study is optional for the patient.


Eligibility Criteria:
Inclusion Criteria:

* Planned or ongoing treatment with cetuximab
* Age at least 18 years
* Informed written consent according to local and national legislation

Exclusion Criteria:

* Known disease that can influence either treatment, evaluation and the outcome of the current disease and treatment, including chronic dermatology
* Known hypersensitivity to menadion
* Concomitant treatment with Vitamin K or Vitamin K-antagonists
* Known psychological, family, sociological or geographic conditions which potentially can influence planned study treatment or follow-up
Memory Rehabilitation Strategies in Patients With Multiple Sclerosis

The clinical characteristics of MS are extremely variable from one patient to another. In about 60% of cases, motor disabilities are associated with cognitive deficits. The present study aims to compare three forms of cognitive / motor rehabilitation in three groups of patients with MS: rehabilitation of verbal memory with the Rehacom program; combined rehabilitation, associating a motor rehabilitation path with the Rehacom program; only motor rehabilitation course. Aims of the study will be: to verify whether the combined cognitive / motor rehabilitation can induce a significantly greater improvement in the memory performance of patients with MS compared to rehabilitation alone; check whether any improvement is objectively verifiable by patients and the impact it may have on patients' quality of life; monitor these effects after 6 months.

For these purposes, three homogeneous groups of 20 patients each will be enrolled, diagnosed with MS according to Mc Donald's criteria revisited by Polman (2011). The study will be divided into an initial clinical, cognitive, emotional, quality of life and functional self-perception (T0) assessment. Subsequently, the patients assigned to the three conditions will be provided with the pre-established rehabilitation treatments for a total duration of 12 weeks; at the end, each patient will undergo an overall re-evaluation (T1). Finally, a further overall reassessment will be carried out after 6 months, aimed at follow-up monitoring (T2).

Statistical analyzes will be of two types:

Within Group (aimed at assessing any improvement in the cognitive performance of each group of patients by comparing the assessments at T0 with those at T1 and T2); Between Group (aimed at comparing the results obtained by each group with those of the other 2 groups at T0, T1, and T2).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS defined according to McDonald's diagnostic criteria revised in 2011.
* RRMS or SPMS phenotype.
* Language Italian mother tongue.
* EDSS score \<6.0

Exclusion Criteria:

* Neurological or psychiatric pathologies other than MS that can interfere with cognitive functioning
* Clinical relapses in the three months prior to enrollment
* Severe mental illness
* Psychiatric disorders severe enough to interfere with cognitive functioning
* Medications Steroid therapy in the 3 months prior to enrollment
* Motor limitations Upper limb dysfunction (paralysis or tremor) that does not allow to hold the PC mouse
* Sensory limitations Visual acuity impaired enough to not allow reading of the instructions to the various tests
Combination Treatment With Green Tea Extract and Statins in Patients With Hypercholesterolemia

There is a positive correlation between serum's cholesterol levels and death from cardiovascular disease, especially coronary artery disease. The reduction of plasma lipids levels is one of the main goals of prevention. Research has shown that green tea has beneficial effects on health due to the polyphenolic substances (catechins) that it contains. Studies have shown that prolonged consumption of polyphenols has a positive effect on factors related to cardiovascular risk such as obesity, dislipidemia and various indicators of oxidative stress.

The aim of this study was to examine the possible effects of catechin supplementation, in combination with the classic treatment for the reduction of hypercholesterolemia, statin therapy, on the treatment's effectiveness and in the reduction of classic side effects.

This is a randomized, double - blind placebo controlled trial. The patients will be divided randomly in two groups; one group will receive statin and catechin, while the other statin and placebo for 12 weeks. The experimental group will receive 20 mg atorvastatin (Lipitor) daily and 600 mg of catechin in capsules, while the control group will receive 20 mg atorvastatin (Lipitor) and Placebo in identical capsules of 600 mg for the same time period.

The patients will undergo biochemical evaluation in which the serum lipids, the levels of oxidative stress and the antioxidant capacity will be assessed. Body composition will be calculated with anthropometric measurements, while the levels of visceral fat, the subcutaneous fat, as well as the level of liver fat infiltration will be examined with the use of computed tomography images. Factors related to the patients' quality of life will be assessed by a series of questionnaires.

The investigators hypothesized that the combination treatment with statin and green tea extract (catechins)will improve in a greater extent the lipidemic profile, increase antioxidant capacity, reducing significantly visceral fat and intrahepatic lipids content.

Eligibility Criteria:
Inclusion Criteria:

* Total cholesterol \>200mg/dl, or LDL \>160 mg/dl

Exclusion Criteria:

* normal lipidemic profile, on statin medication, diabetes mellitus, liver disease, severe hypertension, pregnancy, or severe side effects after 4 weeks of treatment