cyrilzakka/clinical-trials huggingface dataset:
Endoscopic Characterization of Colorectal Neoplasia With the Different Published Classifications

Endoscopic characterization is now essential in front of a colorectal lesion to predict its histology and choose the best therapeutic strategy. Different classifications have been proposed to predict histology depending on the endoscopic aspect. Thus, the aspect of the shape of the lesion is described in the Paris classification, the aspect of the mucosal pattern in Kudo's classification and the vascular pattern in Sano's one. Recently, classifications combining several color and mucosal and vascular pattern criteria have been described as the NICE classification or even more recently the Japanese JNET classification. However, although the interest in combining the Paris, Sano and Kudo criteria has recently shown its interest, there was not yet an overall classification covering all the published criteria. We have created a synthetic classification called CONECCT grouping the different criteria for an initial educational purpose. We have demonstrated that this tool allows interns and gastroenterologists to progress in the histological prediction of colorectal lesions presented in the form of photo files. Nevertheless, comparative data of the performances of those different classifications to predict the histology and the concordance intra and inter-observer have never been published. To validate this CONECCT classification, we created this comparative study evaluating the endoscopic characterization performances of these different classifications in terms of histological prediction and intra- and interobserver concordance in a group of gastroenterologists with varying levels of expertise in front of colorectal lesions presented in the form of photographic records.


Eligibility Criteria:
Inclusion Criteria:

* The participants were gastroenterologist doctors (experts, general or internal).
* Lesions presented were resected endoscopically after completion of a picture file.
* Pathology available for presented lesions.
* Participants signed informed consent and voluntarily participated in the characterization of these 206 lesions.

Exclusion Criteria:

* None
Safety, Tolerability, and Pharmacokinetics of KarXT and Dual-burst Release of Xanomeline With Immediate-release Trospium Chloride in Adolescents With Psychiatric Disorders

This study is designed to assess the safety, tolerability, and pharmacokinetics (PK) of multiple doses and ratios of xanomeline and trospium chloride in an IR capsule (KarXT) and dual-burst release of xanomeline with immediate-release trospium chloride in adolescents with psychiatric disorders.


Eligibility Criteria:
Inclusion Criteria:

* LAR (ie, legal guardian or caregiver) must have signed and dated an IRB/IEC-approved ICF in accordance with regulatory, local, and institutional guidelines.
* Confirmed Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) psychiatric diagnosis of 1 of the following:

  1. Schizophrenia or schizoaffective disorder
  2. Bipolar I or II disorder
  3. Attention-deficit/hyperactivity disorder (ADHD)
  4. Tourette's disorder
  5. Autism spectrum disorder (ASD)
* Participant is judged by the investigator to be clinically stable (eg, no psychiatric hospitalization within the last 6 months; no imminent risk of suicide or injury to self, others, or property).

Exclusion Criteria:

* Any clinically significant neurological, metabolic (including type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, GI (including active obstructive GI disorders), carcinoma, active biliary disorders (eg, symptomatic gallstones) and/or urological disorder, congestive heart failure (uncontrolled), or CNS infection that would pose a risk to the participants if they were to participate in the study or that might confound the results of the study.
* Participant has a risk for suicidal behavior during the study, as determined by the investigator's clinical judgment and C-SSRS.
* eGFR \< 60 mL/min.
* History of Gilbert's Disease or history of liver disease (Child-Pugh class A and higher).
* History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.
* Participants with history of bladder stones or recurrent UTIs.
* Other protocol defined inclusion/exclusion criteria apply.
A Study of APG-2575 in Patients with Mild-to-moderate Systemic Lupus Erythematosus.

To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE).

This is a randomized, double-blind, placebo-controlled Phase I/II study. About 40 participants will be recruited to receive either APG-2575 or a placebo, with doses from 200mg up to 800mg.

Eligibility Criteria:
Inclusion Criteria:

* 1. Diagnosis of systemic lupus erythematosus for at least 6 months.
* 2. On stable treatment for systemic lupus erythematosus before first dose at least 28 days.
* 3. SLEDIA-2000 score: 4-12
* 4.Other than systemic lupus erythematosus, subject should be in general good health.

Exclusion Criteria:

* 1. Severe systemic lupus erythematosus.
* 2. Significant autoimmune disease other than lupus.
* 3. Significant, uncontrolled or unstable disease in any organ.
Effect of Physical Activity on Weight Loss and Cardiovascular Risk Factors After Gastric Bypass

The aim of this study is to increase our knowledge about the effect of physical activity in patients who have undergone gastric bypass surgery. The study will provide novel information in two areas. The main objective is to study the effect of physical activity on the weight loss and cardiovascular risk factors. This will be accomplished in a randomized clinical trial in patients, who are eligible for gastric bypass (GB). Patients will be randomized to six month of structured physical activity or standard postoperative counseling. The study will include an exhaustive panel of blood tests related to cardiovascular risk and the most extensive evaluation of structural and functional vascular test done in this patient group so far. In addition the study will provide information of the effect of bariatric surgery per se since both pre- and postoperative investigations are conducted. The study will learn us to what degree it is possible to motivate this group of patients to increased physical activity. All together this will enable us to improve the counseling of the patients undergoing GB.

The study will be conducted as a prospective, randomized, controlled, two-group, intervention study. Patients will be recruited among individuals referred to the tertiary center for bariatric surgery. The patients will be asked to participate in the study when they attend the preoperative education for bariatric surgery. Randomization will be performed in blocks ensuring an equal distribution of type 2 diabetes patients in the two study groups.

Participants will be investigated before gastric bypass surgery, six, 12 and 24 month post-operative. Intervention, consisting of structured physical activity will take place from six to 12 month after operation.

The intervention program will continue for six month. The supervised exercise program will take place at the training center consisting of 40 min. sessions two times pr. week for 26 consecutive weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 25 - 60 years
* Able to understand and cooperate with the interventions in the study
* Eligible for gastric bypass surgery

Exclusion Criteria:

* Inability to perform physical activity at the intensity and quantity required in the study, such as physical disabled patients including severe osteoarthritis
* Use of vitamin K antagonists, oral contraceptives, or hormone replacement therapy
Randomized, Crossover Safety and Pharmacokinetics Study of PT010

Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese Descent Following a Single Dose and After Chronic Dosing for 7 Days.

This is a Phase I, single-center, randomized, double-blind, placebo-controlled, two period, ascending dose, cross-over study to assess safety and PK of two doses of PT010 in healthy adult subjects of Japanese descent. Safety and PK will be assessed following a single dose and during twice-daily (BID) chronic dosing for 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent Form (ICF) prior to any study related procedures
* Male and female subjects first generation Japanese subjects 18 to 55 years, inclusive
* Body weight ≥50 kg (110 lbs) at the Screening Visit and body mass index between 18.5 and 32 kg/m2, inclusive
* Good general health
* Medically acceptable contraception for women of child-bearing potential and males with female partners of childbearing potential
* Clinical labs within normal ranges or determined to be not clinically significant by the Investigator

Exclusion Criteria:

* Pregnancy, nursing female subjects, or subjects trying to conceive
* Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
* History of ECG abnormalities
* Cancer not in complete remission for at least 5 years
* Clinically significant, symptomatic prostatic hypertrophy
* Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening
* Clinically significant bladder neck obstruction or urinary retention
* Inadequately treated glaucoma
* History of an allergic reaction or hypersensitivity to any drug or to any component of the formulations used in this study
* Subjects with pre-existing anemia and/or iron deficiency
Carbon Monoxide's Headache Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow

In this study the investigators will research the hypothesis that the gas carbon monoxide induces headache and increases the blood flow velocity in the middle cerebral artery.

To investigate headache score and accompanying symptoms during and after inhalation of carbon monoxide.

With transcranial Doppler imaging, c-scan and laser speckle the investigators will investigate changes in blood flow velocity of the middle cerebral artery (MCA), diameter of the superficial temporal artery (STA), the radial artery and facial skin perfusion.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Aged 18-50
* 50-100 kg

Exclusion Criteria:

* Tension type headache more than once/month
* Other primary headaches
* Daily medication except contraceptives
* Drug taken within 4 times the halflife for the specific drug except contraceptives
* Pregnant or lactating women
* Exposure to radiation within the last year
* Headache within the last 24 hours before start of trial
* Hypertension
* Hypotension
* Respiratory or cardiac disease
* Smoking
* Primary relatives with current or previous migraine
Use of the SMART COPD Physical Activity App in Pulmonary Rehabilitation

The investigators are carrying out a feasibility study to explore whether an app for physical activity in Chronic Obstructive Pulmonary Disease (COPD) is acceptable to people with the condition and to healthcare professionals who help patients manage the condition.

Chronic Obstructive Pulmonary Disease (COPD) is a long term lung condition which causes breathlessness, tiredness, coughing and chest infections. People with the condition often find it difficult to carry out day to day activities and to live a normal life. In recent years people with COPD have been encouraged to self-manage their condition, for example by increasing their physical activity, which could help them to live their life to the full. Recent advances in technology have the potential to help people do this. The SMART COPD 'app' which is being used in this study has been developed, based on previous research and the views of people living with the condition, to help people with COPD increase their physical activity. Physical activity is known to be important in helping people with COPD to enjoy better health and to carry out activities. The current study will investigate whether or not the app could be used alongside existing health services, and whether or not people with COPD, as well as healthcare professionals, find the 'app' acceptable and easy to use.

The investigators are working with three Pulmonary Rehabilitation (PR) teams in South Yorkshire (from Sheffield, Rotherham and Doncaster). PR is an education and exercise programme for people with lung conditions, which aims to teach people the skills to help them self-manage their condition. The first part of this feasibility study will investigate how PR is currently being delivered, and whether there would be any scope to include the app during and after PR to help people increase (or at least maintain) their physical activity levels longer term. This will be done by observing PR sessions, looking at how PR is delivered and referrals to the service, and through interactive workshops with healthcare professionals who deliver PR. The second part of the project will involve 'trying out' the app with a small group of people with COPD who are attending PR, to investigate whether the app is easy to use, whether any changes are needed, and the best way to use the app in the future. In order to determine whether the app successfully helps people with COPD to increase their physical activity levels, the investigators will need to carry out a much larger study in the future which compares use of the app with not having the app. The current feasibility project will help with planning this much larger study.

Eligibility Criteria:
Inclusion Criteria:

* A formal diagnosis of COPD;
* Attending a Pulmonary Rehabilitation (PR) course in Sheffield, Rotherham or Doncaster;
* Reasonable understanding of written and verbal English.

Exclusion Criteria:

* Not formally diagnosed with COPD;
* Deemed unable to attend standard PR;
* A cognitive impairment which prevents an individual giving informed consent;
* Does not understand written and verbal English.
A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients

The primary objective of this study is to examine the effects of SB-480848 on plasma lipoprotein associated phospholipase A2 (Lp-PLA2) activity in dyslipidemic patients during a 4-week treatment with SB-480848.


Eligibility Criteria:
Inclusion criteria:

Dyslipidemic subject who is currently undergoing statin therapy and no change in lipid-lowering therapy or dose during the 4 week prior to randomization

Exclusion criteria:

1. Recent (i.e.,\<6 months prior to screening) CV event and/or vascular procedure defined as:

   A)ST-elevation MI or non-ST-elevation MI B)Unstable angina C)Coronary revascularization \[(percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)\] D)Stroke of any etiology E)Peripheral arterial disease with critical limb ischemia (resting pain or ischemic skin lesions, either ulcers or gangrene) F)Resuscitated cardiac arrest
2. Planned CABG or planned PCI or planned major non-cardiac surgery within study period
3. No measurable Lp-PLA2 activity in plasma (\<10 nmol/min/mL) at screening
4. Change in a lipid-lowering medication, regimen or dosage during the 4 week prior to randomization
5. Poorly controlled dyslipidemia (LDL-c \>=160 mg/dL) at screening
Furosemide as Supportive Therapy for COVID-19 Respiratory Failure

This double-blind, placebo-controlled, randomized, parallel-group phase 2/3 study will study the utility of nebulized furosemide for pulmonary inflammation in Intubated, mechanically ventilated Patients with COVID-19.

This double-blind, placebo-controlled, randomized, parallel-group phase 2/3 study will study the utility of nebulized furosemide for pulmonary inflammation in Intubated, mechanically ventilated Patients with COVID-19. The primary objective of the study is to establish the efficacy and safety of nebulized furosemide for the treatment of respiratory failure secondary to COVID-19 infection requiring invasive mechanical ventilation. The secondary objective is to delineate the anti-inflammatory properties of furosemide in COVID- 19 patients using pharmacokinetic / pharmacodynamic analysis. The duration of the intervention will be up to 28 days of intervention and patients will be followed till 60 days post randomization. Participants will be randomized to either: Intervention Group: 40 mg furosemide per dose, given by nebulization (4 mL of 10 mg/mL furosemide in 0.9% saline solution) over 30 mins four times daily (Q6H) for up to 28 days OR Control Group: placebo, given by nebulization (4 mL of 0.9% saline solution) over 30 mins four times daily for up to 28 days. One hundred and forty-four (144) evaluable patients will be enrolled in the Phase 2 study. If evidence of efficacy is found in the Phase 2 portion, these patients will be enrolled in the Phase 3 study which aims to recruit 640 patients total (496 additional patients to the phase 2 patients).

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with respiratory failure secondary to COVID-19 (SARS-CoV-2) infection/pneumonia requiring invasive mechanical ventilation
2. Duration of mechanical ventilation less than 48 hours as measured from the time of randomization
3. If female, must not be pregnant at the time of enrollment as determined by a serum or urine pregnancy test

Exclusion Criteria:

1. Known history of severe chronic pulmonary disease (e.g., preinfection requirement for home oxygen therapy or presence of chronic hypercapnia (PaCO2\< 50 mm Hg); mild -moderate disease is still eligible in the absence of chronic hypercapnia or need for chronic oxygen therapy)
2. In the opinion of the PI, unlikely to survive for \>48 hours from time of enrollment
3. Enrollment in another trial of anti-inflammatory therapies for COVID-19.
4. Known allergy to furosemide or sulfonamide agents
ABT-888 and Temozolomide for Liver Cancer

This study is for people with liver cancer (also called hepatocellular carcinoma, or HCC in abbreviation).

The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and temozolomide for patients with liver cancer. Temozolomide acts by damaging deoxyribonucleic acid (DNA) in rapidly dividing cells, in other words, cancer cells. ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the temozolomide and will hopefully increase the killing of cancer cells, and decrease the tumors in the body.

ABT-888 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration (FDA) for use in liver cancer.

This study will help find out what effects (good and bad) the combination of drugs, temozolomide and ABT-888, has on liver cancer.

This research is being done because it is not known if ABT-888 will increase the effectiveness of temozolomide in liver cancer.

Patients with hepatocellular carcinoma seen at Lombardi Cancer Center were evaluated for the eligibility of this study.

The Georgetown Lombardi Comprehensive Cancer Center was responsible for the data and safety monitoring of this trial. As this study is an investigator initiated study Phase II study utilizing a non-FDA approved drug for which the PI held the IND it was considered a high risk study which had real-time monitoring by the PI and study team and quarterly reviews by the LCCC Data and Safety Monitoring Committee (DSMC).

Eligibility Criteria:
Inclusion Criteria:

* Pathological confirmation of HCC or noninvasive criteria following AASLD guidelines
* Measurable or evaluable disease based on RECIST criteria
* Progressive disease on sorafenib or intolerance to sorafenib
* ECOG performance status 0-2
* Child Pugh Class A or B
* Adequate hepatic, bone marrow, and renal function

Exclusion Criteria:

* Prior ABT-888 or other PARP inhibitor treatment
* Anticipation of need for major surgery during the study
* Any of the following within 6 months before enrollment: myocardial infarction, severe/unstable angina, congestive heart failure, or severe pulmonary disease
* Women who are pregnant or lactating
* Women and men of child-bearing potential who are not using a reliable form of contraception
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ABT-888 and temozolomide
* Concurrent malignancy (i.e. malignancy other than hepatocellular cancer) unless 1) the subject has been curatively treated and disease free for at least 2 years or 2) the cancer was non-melanoma skin cancer or early cervical cancer.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (excluding active hepatitis B or C) or psychiatric illness/ social situations that would limit compliance with study requirements
Influence of Interferential Current Therapy in the Treatment of Individuals With Shoulder Impact Syndrome: A Randomized, Placebo Controlled Clinical Trial.

This project will analyze the influence of interferential current therapy in an exercise program for individuals with a unilateral impact syndrome diagnosis. To that end, volunteers of both genders, aged 18-59 years, had an unilateral, unilateral pain in the shoulder with more than 3 months duration, at least grade 4 pain by the numerical scale of pain assessment, positivity In at least 2 of 3 orthopedic tests for impact syndrome, will be randomized into the following groups: exercise group, exercise + ultrasound group, exercise group + interferential current. Sixteen consecutive treatment sessions will be performed, and the volunteers will be evaluated before and after, by means of the following instruments: Numerical scale of evaluation of pain, Shoulder pain and disability index (SPADI), Pain-Related Catastrophizing Thoughts Scale, being applied the Numerical scale of evaluation of pain at the end of Each session and one month after the end of treatment.


Eligibility Criteria:
Inclusion Criteria:

* History of anterolateral, unilateral pain in the shoulder with more than 3 months duration.
* Medical diagnosis,
* minimal grade 4 pain by numerical scale of pain assessment,
* positivity in at least 2 of 3 orthopedic tests for impact syndrome: Neer, Hawkins or Jobe.

Exclusion Criteria:

* Fibromyalgia diagnosis,
* pregnancy,
* numbness or tingling in the upper limb
* History of shoulder trauma, other shoulder related diseases,
* ruptured tendons, ligament laxity,
* symptoms of numbness and / or Tingling in the upper limbs, history of shoulder and / or cervical surgery
* use of corticosteroid injection in the shoulder, and analgesic, anti-inflammatory or muscle relaxant use and have or have undergone physiotherapeutic treatment in the last 6 months.