cyrilzakka/clinical-trials huggingface dataset:
A Phase I/II Study With BM7PE Immunotoxin in Colorectal Cancer Patients

This phase 1/2 study will evaluate the safety, tolerance and dose of BM7PE treating patients with colorectal cancer who have progressed to standard cell therapy or cannot tolerate such therapy. The study starts as a phase 1 study with the aim of assessing the final dose for this group of patients. Based on the results, the study will continue into a phase 2. The phase 2 study aim to examine overall survival ≥ 9.3 months.


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified adenocarcinoma of colon or rectum
* Ambulatory with an ECOG performance status 0-1
* At least 18 years of age
* Progressive disease on or last line of standard chemotherapy or intolerance to further chemotherapy
* Laboratory values as the following: ANC, Platelets, Hb, Creatinine, Bilirubin, ASAT, ALAT, Albumin levels, INR
* Signed informed consent and expected cooperation of the patients for the treatment, and follow-up must be obtained and documented according to ICH GCP, and national/local regulations

Exclusion Criteria:

* History of prior metastatic disease the last 3 years
* History of CNS or bone metastases
* Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia
* Chemotherapy/radiation therapy or major surgery within the last 4 weeks before start of treatment
* Alcohol or drug abuse
* Any reason why, in the opinion of the investigator, the patient should not participate
* Has a known history of Human Immunodeficiency Virus (HIV)
* Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected)
* Is pregnant or breastfeeding, or expecting to conceive or father children within the project duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
Evaluating 18F-FDG PET/CT With Liver SUVmax-based Criteria for Prognosis of Patients With Peripheral T-cell Lymphoma

The purpose of this study is to evaluate whether a semi-quantitative interpretation using the liver SUVmax as reference can better interpret 18F-FDG PET/CT and predict disease progression during chemotherapy or survival in PTCL.

In this study investigators develope a semi-quantitative interpretation using the liver SUVmax as reference to interpret 18F-FDG PET/CT. Positive lesions in PET were indicated as SUVmax of residues higher than the threshold or new 18F-FDG avid lesions. Investigators compare the prognostic accuracy of the liver SUVmax-based criteria with the 5-PS criteria and ΔSUVmax interpretation with respect to predicting disease progression during chemotherapy or survival in PTCL. Furthermore,investigators improve the prognostic ability of interim PET/CT by comparing the results to the clinical prognostic factors.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed PTCL
* treated using an anthracycline-containing regimen
* minimal follow-up at 6 months after the completion of first-line treatment
* complete medical history and clinicopathological data

Exclusion Criteria:

* secondary malignant disease
* serious infection or inflammation (e.g., HIV)
* primary central nervous system lymphoma
* hepatic or renal dysfunction.
The Oakland Men's Health Disparities Study

Reducing racial disparities in health outcomes is a major policy concern in the United States. Although there has been recent progress to close the gap, black men continue to experience earlier morbidity and mortality from preventable and manageable medical conditions, and live on average 4.2 years less than their white male peers. An oft-prescribed solution to close this stubborn gap is to increase the diversity of the healthcare workforce. Another common policy tool to increase take-up of preventative healthcare services is financial incentives. In this randomized evaluation, we will estimate the effects of financial incentives and a racially concordant physician on the uptake of preventive health services in Oakland, California.


Eligibility Criteria:
Inclusion Criteria:

* African American male adults

Exclusion Criteria:

-
Parafunctional Habits and Temporomandibular Disorder in Adolescents

The disorders that affect the temporomandibular joint (TMJ) are responsible for the diverse symptoms. Objective: To evaluate whether or not the relationship between signs or symptoms of TMD and presence of harmful habits. The investigators evaluated 244 adolescents enrolled in public school . The investigators used the questionnaire for selection of orofacial pain and temporomandibular disorders, recommended by American Academy of Orofacial Pain to assess the presence or absence of signs and symptoms of TMD.

For the assessment of signs and symptoms of TMD and parafunctional habits, 244 adolescents between 10 and 20 years of age and enrolled in a municipal school system were analyzed. The participants were submitted to the self-explanatory questionnaire for screening recommended by the American Academy of Orofacial Pain for the determination of orofacial pain and TMD. This questionnaire is made up of ten guided questions with yes or no responses to the most frequent signs and symptoms of orofacial pain and TMD. According to the Academy, three or more affirmative responses are an indication of TMD. Patient history and a detailed clinical exam were performed for the assessment of the presence or absence of parafunctional habits.

The frequency of signs and symptoms was analyzed and the data were described based on gender and age. The SPSS 12.0 program was used for the statistical analysis and the data were treated using the chi-square test.

Eligibility Criteria:
Inclusion Criteria:

* age: 10 to 20 years old

Exclusion Criteria:

* no signing a term of informed consent
Accurate Recognition of Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

It has been observed that COPD exacerbations are under-reported in China. One of the reasons for this is Chinese subjects with COPD cannot describe the symptoms of exacerbation mentioned in English. Hence this study aims to create a tool called CERT that will help Chinese physicians and subjects with COPD to recognize and report exacerbations. The study will be carried out in 4 stages: item identification, cognitive briefing, item reduction and creation of final CERTs. Two CERTs will be prepared, one for subjects with COPD and another for physicians. A total of approximately 200 subjects will be included in the study and each subject will contribute to only one step.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of age greater than or equal to 40 years.
* Spirometrically confirmed COPD according to diagnostic criteria in Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2016.
* A treated exacerbation of COPD within 3 months prior to the study visit.
* Willing and able to provide informed consent, and able to participate in focus groups or cognitive interviews.
* Literacy is not a requirement for any of the groups.

Exclusion Criteria:

* Current diagnosis of asthma or clinically relevant bronchiectasis. Note: Subjects with Asthma COPD Overlap Syndrome (ACOS) are eligible.
* Subjects with a concurrent significant, uncontrolled, active medical condition or disease state of other organ diseases or systematic diseases; psychiatric condition; cognitive impairment or any other reasons that in the investigator's opinion, would place subjects at risk or interfere with study evaluation or affect participation in the study.
Physiological and Sensory Responses to Prolonged Fasting in Humans

This study aims to establish the metabolic/molecular response in both adipose tissue and skeletal muscle as well as sensory experiences (pain, fatigue, drive) to prolonged fasting of 3 days duration. Participants will undergo sequential meal assessment before and after a 3 day fast with measures taken throughout each fasting day.

This study will employ a single-arm, non-randomised design in which participants will act as their own control prior to undergoing 3 days of fasting. The control phase includes 3 days of habitual energy balance assessment before coming into the laboratory for baseline meal testing with blood, muscle, and adipose samples as well as anthropometric assessment.

Participants will then be provided with a standardised lunch to be consumed around midday and a standardised dinner to be consumed at 2000 h.

Participants will then be asked to refrain from caloric intake for 3 days until they return to the laboratory for follow up measures.

Participants will be provided with monitoring equipment throughout the 3 days of fasting and will be asked to provide a blood sample at 0800 h each day alongside self recording of blood pressure, weight, and urinary ketones each day. On the middle day (day 2) participants will also be asked to come into the lab to provide a blood sample at 2000 h.

The follow up visit will be identical to that performed before the fast, including meal testing, blood, muscle, and adipose samples.

Eligibility Criteria:
Inclusion Criteria:

* • Body mass index 20.0-29.9 kg∙m-2

  * Age 18-45 years
  * Willing to abstain from food intake for just over 3 days (\~82 hours)
  * Able and willing to provide informed consent and safely comply with study procedures
  * Females to maintain record of regular menstrual cycle phase or contraceptive use
  * No anticipated changes in lifestyle during the study (e.g. holidays or exercise programmes)

Exclusion Criteria:

* • Any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias

  * Any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes)
  * Any reported use of substances which may pose undue personal risk to the participants or introduce bias into the experiment
  * Pregnancy
  * Breastfeeding
  * Lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker)
  * History of eating disorders (e.g. anorexia)
  * Any reported recent (\<6 months) change in body mass (± 3%)
  * Uncontrolled hyperthyroidism
  * Advanced cerebrovascular insufficiency or dementia
  * Advanced liver or kidney insufficiency
  * History of migraine and or headache
  * Psychotic disorders
  * Unstable or severe coronary artery disease
  * Retinal detachment
  * Duodenal or stomach ulcer
  * Cancer and malignant disease
  * Regular use of Non-steroidal anti-inflammatory drugs (NSAIDs)
  * Use of Systemic corticoids
  * Use of Antihypertensives (especially beta-blockers and diuretics)
  * Use of Antidiabetics
  * Use of Anti-coagulants
  * Use of Psychotropics (especially neuroleptics and lithium)
  * Use of Anticonvulsants.
Study to Evaluate the Effects of RO7496998 (AT-527) in Non-Hospitalized Adult and Adolescent Participants With Mild or Moderate COVID-19

This study will evaluate the efficacy, safety, antiviral activity, and pharmacokinetics of study drug RO7496998 (AT-527) compared to placebo in non-hospitalized adult and adolescent participants with mild to moderate coronavirus disease 2019 (COVID-19) in the outpatient setting.


Eligibility Criteria:
Inclusion Criteria:

* Positive SARS-CoV-2 diagnostic test (RT-PCR or validated rapid antigen test) ≤72 hours prior to randomization
* At least three of the following symptoms of at least moderate (score ≥2 as per COVID-19 Symptom Diary) intensity: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills or sweats, feeling hot or feverish, nausea, vomiting, or diarrhea.
* Has symptoms consistent with mild or moderate COVID-19, as determined by the investigator, with onset ≤5 days before dosing on Day 1

Exclusion Criteria:

* Clinical signs indicative of COVID-19 illness requiring hospitalization
* Admitted to a hospital prior to randomization or is hospitalized (inpatient) at randomization due to COVID-19
* In the opinion of the investigator, is likely to experience imminent deterioration and require hospitalization
* Treatment with an investigational drug within 5 half-lives or 3 months (whichever is longer) of randomization
* Treatment with a COVID-19 therapeutic agent including, but not limited to, other direct or indirect acting antivirals against SARS-CoV-2 (such as remdesivir or favipiravir), systemic or inhaled steroids (such as dexamethasone or inhaled budesonide), colchicine, ivermectin, interferons, convalescent plasma, monoclonal antibodies against SARS CoV-2 or interleukin 6 (IL-6), intravenous immunoglobulin or other EUA-approved treatments within 3 months or less than 5 drug elimination half-lives (whichever is longer) prior to the screening visit
* Concomitant use of P-glycoprotein inhibitors or inducers listed as prohibited therapy in the protocol
* Known allergy or hypersensitivity to components of study drug
* Abnormal laboratory test results at screening
* Requirement of any prohibited medications during the study
* Other known active viral or bacterial infection at the time of screening, such as influenza
* Any clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, could jeopardize the safety of the patient or affect patient compliance or safety/efficacy observations during the study
* COVID-19 vaccination within ≤ 40-days prior to enrollment (second dose if applicable)
12-hour Versus 24-hour Postpartum Magnesium Sulphate for Preeclamptic Patients

To compare the use of magnesium sulfate for 12 hours versus 24 hours in postpartum women with pre-eclampsia with severe features , to ensure maximum efficacy of anticonvulsant action that can be achieved with least exposure to Mgso4 side effects.

Hypertensive disorders of pregnancy constitute one of the leading causes of maternal and perinatal mortality worldwide. It has been estimated that preeclampsia complicates 2-8% of pregnancies globally.

Preeclampsia is a disorder of pregnancy associated with new-onset hypertension, which occurs most often after 20 weeks of gestation and frequently near term. Although often accompanied by new-onset proteinuria, hypertension and other signs or symptoms of preeclampsia may present in some women in the absence of proteinuria. Recently preeclampsia is divided into preeclampsia with severe features, preeclampsia without severe, features. One of serious complication of preeclampsia is occurrence of eclampsia. Eclampsia refers to the occurrence of new-onset, generalized, tonic-clonic seizures or coma in a woman with preeclampsia. Eclampsia can be prevented with magnesium sulphate, which decreases the risk of seizures by 50%, paralleled by a reduction in maternal mortality. It is considered as the gold standard of management of eclampsia Although magnesium sulphate administration is recommended for all women with severe preeclampsia, consensus has not yet to be reached on the ideal duration of prophylactic postpartum anticonvulsant therapy. The use of magnesium sulphate has been recommended for 24 hours following delivery, the period of greatest risk for the occurrence of eclampsia. There are other regimen 12-hour, 6-hour Use of magnesium sulphate therapy is not without complications, consequently longer duration therapy possesses the risk of magnesium toxicity such as respiratory depression, renal and neuromuscular dysfunction. Risks of these complications require regular supervision; hence it is particularly important to assess the minimum effective duration of treatment

Eligibility Criteria:
Inclusion Criteria:

* Patients who have pre-eclampsia with severe features as defined by American College of Obstetricians and Gynecologists guidelines 2019(defined in methodology)
* Singleton pregnancy.
* who accept to participate the study.

Exclusion Criteria:

* Patients with eclampsia
* Epilepsy
* Central Nervous System disorder
* Chronic kidney disease
* Seizures due to metabolic disturbances, space occupying lesions or intra cerebral infections
* Cardiac patients
* Hypersensitivity to Mgso4
Impact of Simulation-Based Training on the Safety of Medication Administration

Task interruption is part of professional life. The healthcare world is not exempt from this phenomenon. Task interruptions lead to errors and increase the risks in managing patients.

Medication administration is the critical step, in that it is the final step to stop medication errors produced upstream. It therefore requires the full attention of any healthcare professional.

In the field of health, simulation has become an innovative educational tool allowing experiential learning and reflective practice.

The general aim of this study is to objectivize the value of simulation-based training as regards medication administration when task interruptions occur.


Eligibility Criteria:
Inclusion Criteria:

* Nurses from conventional medical and surgical departments participating in the training
* people agreeing to participate in the study

Exclusion Criteria:

* Person refusing the processing of their data
Full Length Versus Proximal Renal Arteries Ablation

Catheter-based renal sympathetic modification has been documented to be effective option for blood pressure control in patients with resistant hypertension, but the safety is still concerned around worldwide. Based on anatomic findings, blocking renal sympathetic nerves at proximity may be enough for successful renal sympathetic modifications. This study was designed to compare the efficacy and safety of full length versus proximal ablation of bilateral renal arteries.

After baseline assessment was completed, patients with resistant hypertension were enrolled, and randomly divided into two groups. This study is going to recruit 40 patients (group 1 VS group 2 = 1:1) with a follow-up duration of one year. Group 1 received ablation from distal to ostial of bilateral renal arteries, group 2 received ablation at proximal of bilateral renal arteries. RDN was performed with saline irrigated catheter. Office and ambulatory blood pressure was measured.

Eligibility Criteria:
Inclusion Criteria:

* office systolic blood pressure of 160 mm Hg or more,
* patients had to be on a stable drug regimen of at least 3 antihypertensive medications with no changes for 1 month before enrollment.
* Despite being treated with at least three antihypertensive drugs(including one diuretic), or confirmed intolerance to medications;
* ≥ 18 years old,;
* did not have any known secondary cause of hypertension;
* had a glomerular filtration rate estimated with the modification of diet in renal disease formula, of 45 ml/min/1.73m2 or more.

Exclusion Criteria:

* patients with type 1 diabetes,
* implanted pacemakers or implantable cardioverter defibrillators;
* pregnant women;
* haemodynamically significant valvular disease;
* patients with renovascular abnormalities(including mild to severe renal artery stenosis, especially caused by atherosclerosis, previous renal stenting or angioplasty, or known dual renal arteries, or diameter of renal artery identified by angiography less than 4 mm and/or length of renal artery less than 2 cm)
Pulsed Electromagnetic Field (PEMF) Therapy in Thumb CMC Arthritis

Long-Term Objective: Determine if high-frequency PEMF therapy reduces pain in patients with thumb carpometacarpal (CMC) joint osteoarthritis (OA).

Study Design and Methods: This will be a randomized controlled pilot study with 60 subjects with CMC OA randomly divided in two groups. Thirty subjects will receive high-frequency PEMF therapy overlying the CMC joint overnight daily for four weeks. The other 30 subjects will receive a sham PEMF therapy device applied to the same joint overnight daily for four weeks. Pain and function questionnaires will be obtained for all patients at enrollment, four weeks, and six weeks.


Eligibility Criteria:
Inclusion Criteria:

* an existing diagnosis of CMC OA by a hand specialist based on clinically (tenderness to palpation at the CMC joint and/or positive CMC grind test) and/or radiographically identified CMC OA
* reported pain intensity during activities of daily living less than 7 on the Numeric Pain Rating Scale (NPRS)

Exclusion Criteria:

* pregnant
* unable to consent
* with current infection in hand or upper extremity
* have had prior fracture, significant hand injury, tenosynovitis, complex regional pain syndrome, and/or Dupuytren's disease affecting the thumb
* history of surgical or procedural intervention for CMC OA in the hand of study interest
* do not speak English
* have hand or wrist implants
* have heart or brain implants
Acceptability of an Acupuncture Intervention in Painful Elderly

The aim is to investigate the feasibility and efficacy of an acupuncture intervention on persistent MusculoSkeletar pain in a long-term geriatric hospital care ward population. The main issue is the acceptability of this type of complementary and alternative medicine in older people, although the efficacy on pain is assessed too.

The first 60 patients wanting to participate are enrolled. For the impaired patients, family or legal representing is solicited. The Regional Ethic Committee agreement was granted. The intervention consists in 8 acupuncture sessions.

Evaluation

* Acceptability : the proportion of patients who complete the whole treatment ; the acceptability at each acupuncture session is recorded.
* Pain : Dolorous Scale . The evaluation is based on pre and post treatment variations. As a high proportion of patients have cognitive impairment, the behavioural pain scale "dolorous" has been chosen after staffs training for all patients, although "extra " auto evaluation is used when possible (EVS). Evaluation takes place after 5 sessions and after the end of the intervention as well as 2 and 4 weeks after the interventionProfessional carers' satisfaction is recorded.

Eligibility Criteria:
Inclusion Criteria:

* age \> 60 years
* chronic musculoskeletal pain
* follow up 10 weeks
* patient or legal representative's agreement to participate and to the informatics treatment of the data

Exclusion Criteria:

* acute pain
* exclusive neurological pain
* coagulation disorders or anticoagulant curative treatment
Fluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk

Patients with coronary heart disease (CHD) or CHD equivalent (e. g. diabetes mellitus) often have abnormalities in lipids (hypercholesterolemia). Besides, hypercholesterolemia is an evident risk factor for atherosclerosis. Hitherto, there are only few studies of patients with primary hypercholesterolemia where the combination therapy with statins (HMG-Co-reductase inhibitors) and ezetimib was investigated. This combination therapy should be more effective in reducing low density lipoprotein cholesterol (LDL-C) and total cholesterol levels compared to monotherapy.

Ezetimibe, a cholesterol-absorption inhibitor, significantly lowers low-density lipoprotein cholesterol (LDL-C) when administered in addition to statin treatment. The effect of ezetimibe on the incidence and progression of vascular disease is elusive. Therefore, our objective was to examine the effects of fluvastatin and fluvastatin plus ezetimibe on lipoprotein subfractions in patients with diabetes mellitus and/or coronary heart disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CHD or CHD equivalent with LDL 100-160 mg/dl
* Male or female sex
* Normal values of CK, AST and ALT
* Normal kidney function

Exclusion Criteria:

* CHD Stage III-IV
* St. p. myocardial infarction or coronary artery bypass grafting
* Pregnancy or breastfeeding
* Premenopausal women without certain contraception
* Known hypersensitivity to HMG-CoA reductase inhibitors or ezetimib