cyrilzakka/clinical-trials huggingface dataset:
Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab

The study was to explore the efficacy of adalimumab in subjects previously treated with infliximab and failed infliximab treatment due to lack of efficacy or intolerance. To explore the safety of adalimumab in subjects previously treated with infliximab.


Eligibility Criteria:
Inclusion Criteria:

* Males and females \>= 18 years of age
* ACR criteria for RA diagnosis for at least 6 months
* Active RA defined as a DAS 28 \>3.2 at study entry
* Unsatisfactory response, loss of response or intolerance to prior infliximab treatment
* A negative pregnancy test for females of childbearing potential

Exclusion Criteria:

* Patient who had previous treatment with cyclophosphamide and chlorambucil
* Treatment within the last 8 weeks with infliximab
* Prior treatment with more than one DMARD or DMARD combination following infliximab treatment
* Prior treatment with biologics (Investigational or Commercial) RA therapies other than infliximab
* History of cancer, other than successfully treated squamous cell or basal cell carcinoma or lymphoproliferative disease
* Prior treatment with total lymphoid irradiation
Helicobacter Pylori Eradication With a New Sequential Treatment

Eradication rates of Helicobacter pylori (H. pylori) with standard triple therapy are disappointing, and studies from several countries confirm this poor performance. The study aimed to assess the eradication rate of a new sequential treatment regimen compared with conventional triple therapy for the eradication of H. pylori infection.

One thousand and forty-nine dyspeptic patients were studied prospectively. H. pylori-infected patients were randomized to receive 10-day sequential therapy \[rabeprazole (20 mg twice daily) plus amoxicillin (1 g twice daily) for the first 5 days, followed by rabeprazole (20 mg), clarithromycin (500 mg) and tinidazole (500 mg, all twice daily for the remaining 5 days\] or standard 7-day therapy \[corrected\] \[rabeprazole (20 mg), clarithromycin (500 mg) and amoxicillin (1 g), all twice daily\]. H. pylori status was assessed by histology, rapid urease test and 13C-urea breath test at baseline and 6 weeks or more after completion of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Presence of active H. pylori infection
* Age \>18 years

Exclusion Criteria:

* Allergy to drug administered
* Liver or kidney failure
* Pregnancy
* Previous treatment for H. pylori infection
A Study in Healthy People to Compare 2 Different Formulations of Nerandomilast Tablets When Taken With or Without Food

The main objective of this trial is to investigate two different formulations of nerandomilast and the effect of food on the pharmakokinetics of the new formulation following oral administration.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m² (inclusive)
* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply.

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.
Biomarkers of Thrombosis as Predictors of Venous Thromboembolism Risk in Cancer Patients

The main venous thromboembolism (VTE) risk prediction model for ambulatory cancer patients is Khorana. Cancer thrombosis is associated with elevated thrombin generation. Its quantification is a promising method for evaluating patient's thrombotic profile.

This study aims to develop a predictive model of VTE risk in ambulatory cancer patients, combining thrombosis biomarkers (D-dimers and thrombin generation potential) with the Khorana score.

This is a prospective observational study that includes newly diagnosed cancer patients proposed for anti-tumor treatment (chemotherapy, immunotherapy or targeted therapies). Patients with disease progression are allowed if chemotherapy-free for 3 months. A 6-month mean incidence of VTE 6-10% is expected, requiring a sample size of 600 patients. Blood sample is collected at inclusion to analyze thrombosis biomarkers and blood count. The primary endpoint is the occurrence of symptomatic or incidental VTE within 6 months of inclusion. Models will follow a logistic approach with K-fold cross-validation (k=10). Model quality will be assessed with Akaike Information Criterion (AIC) and Bayesian Information Criterion (BIC). Decision for entering predictors in multivariate models will be based on p \<.10 in the univariate analysis.

The main aims will be the following:

* Evaluate the utility of the combination of thrombosis biomarkers (D-dimers and thrombin generation potential) with the Khorana score in order to stratify VTE risk in ambulatory cancer patients;
* Determine the potential of this new score in the stratification of cancer patients into high- and low-risk VTE groups, in order to identify patients who would benefit from primary thromboprophylaxis;
* Determine the applicability of the thrombin generation test as an independent factor in the stratification of VTE risk in the cancer population under study;
* Determine the predictive value of D-dimers in the cancer population under study (high versus low risk discrimination).

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years.
* Newly diagnosed cancer patients, proposed for anti-tumor medical treatment (chemotherapy, immunotherapy and targeted therapies).
* Patients with a cancer diagnosis, previously under medical anti-tumor treatments, with disease progression proposed for a new line of anti-tumor treatment, who have not recently received chemotherapy (within the last three months).
* Follow-up in Medical Oncology, Clinical Hematology, and Pulmonology consultations at Centro Hospitalar Vila Nova de Gaia/Espinho.

Exclusion Criteria:

* Major bleeding in the last 3 months.
* Major surgery in the last 28 days.
* Patients on anticoagulation/antithrombotic therapy
* Pregnant or breastfeeding women.
* Patients previously submitted to bone marrow transplantation.
* Inaccessibility to the results of the biomarkers or other elements provided for in the Khorana score.
Effects of Montreal Museum of Fine Arts Visits and Older Community Dwellers With a Precarious State

This study evaluates the effects of MMFA visits on psychological, health, social conditions and personal interactions in older community dwellers with a precarious state and to determine whether these effects may change precarity.

Precarity is a vulnerable state exposing individuals to adverse health, psychological social events. Older adults are exposed to precarity, especially those who were the old generation of immigrants in Canada. Art-based activities have also been proposed to community dwellers and have shown positive effects on health outcomes and are determinants for well-being with aging. The effects of participatory art-based activities on precarity in older adults have never been examined. Recently, the Montreal Museum of Fine Arts (MMFA) developed a new participatory art-based activity which is a 3 month-period of weekly museum visits for precarious populations.

Eligibility Criteria:
Inclusion Criteria:

* Being 65 years and over;
* Precarious condition defined with a score ≥30 (/100)
* Having an Internet access with an electronic device (i.e.; laptop, computer, smartphone, tablet) as the repetitive assessments for this study will be performed on the web platform of the Centre of Excellence on Longevity of McGill University;
* Understanding and writing the different languages of the recruitment centre (i.e., French, English, Chinese.);
* Severe frail condition determined with the Centre of Excellence self-administered questionnaire (CESAM)
* Living in Montreal

Exclusion Criteria:

* A concomitant participation to another clinical trial;
* Participation in another art-based activity;
* Palliative care;
* Living in residence;
* Having a moderate to severe mobility impairment (i.e. using a walker, a wheelchair or being unable to walk alone 10m).
Acceptance and Commitment Therapy for Informal Caregivers of People With Dementia

Dementia has a major impact on people with dementia and their family. Informal caregivers of people with dementia are at higher risk of developing depressive symptoms compared to informal caregivers of people with other chronic diseases. Therefore, supporting this group of informal caregivers is particularly important. With an online program based on Acceptance and Commitment Therapy (ACT), this study supports caregivers of people with dementia to lead a more meaningful and less stressful life. In addition to following the online program, caregivers are supported weekly by a coach, who helps to set goals, map important values in life, and take actions in relevant areas. The current study aims to examine the (1) feasibility and acceptability of the intervention and its procedure and; (2) preliminary effectiveness of the intervention on clinical outcomes (e.g. psychological flexibility and self-competence); and (3) maintenance of change after the intervention in short-and long-term follow-ups. This study includes a single-arm, non-randomized trial with a baseline assessment, a 9-week internet-based intervention period, a post-intervention assessment, and two follow-ups at 3 and 6 months. ACT is a promising form of therapy that has previously been shown to be effective in increasing the mental well-being of caregivers. However, this is the first study to combine online ACT modules, goal-setting, and weekly coaching for informal caregivers of people with dementia.


Eligibility Criteria:
Inclusion Criteria:

* Adult informal caregivers (at least 18 years old)
* Access to the internet and having a tablet or computer
* Self-identified primary informal caregiver of a person diagnosed with dementia
* Taking care of the care recipient at least once a week for a period of at least three months
* Obtained informed consent \*General (psychological) support from case managers will not count as professional psychological support, and therefore, informal caregivers who receive support from the case managers will also be included.

Exclusion Criteria:

* Caregivers who report having a cognitive disorder in their clinical record will be excluded (based on self-report).
* Caregivers who receive psychotherapy or psychopharmacological treatment within the last 3 months will be excluded (based on self-report).
Effects of Two Hypocaloric Diets on Weight Loss

The investigators evaluated whether an energy-restricted protein diet with low glycaemic index carbohydrates and soluble fibers (LC-P-LGI) would be more effective than a conventional diet (LC-CONV) on weight-loss and related metabolic variables.

The subjects (9 men and 5 post-menopausal women) were randomly allocated, in a cross-over design, to two periods of 4 weeks of an energy restricted diet of 1200 kcal as either a conventional diet (LC- CONV) or a special energy restricted diet compensated by proteins (LC-P-LGI). The two nutritional periods were separated by a wash-out interval of 8 weeks. Before the start of the study, all subjects were instructed to maintain their usual lifestyle during the experimental period.Anthropometric parameters, glucose and lipid homeostasis and inflammatory markers were evaluated before and after each dietary period.Body fat and fat-free mass distributions were measured by a dual-energy X-ray absorptiometry (DXA, GE Lunar Prodigy Corporation, Madison, WI, USA) before and after each dietary period at the fasting state.

Eligibility Criteria:
Inclusion Criteria:

* BMI 26 to 35 Kg/m2
* 25 to 60 years old
* non diabetic subjects

Exclusion Criteria:

* SGOT and SGPT \>2.5x the normal
* plasma glucose more than 1.26 g/l
* hepatic or renal or cardiac failure
a Low-residue Diet for Bowel Preparation

Previous researches demonstrated that a prepackaged low-residue diet (LRD) could achieve better bowel preparation quality compared with a self-prepared LRD. However, up to now, there has been no widely acceptable standard of LRD for bowel preparation. Moreover, these prepackaged LRD adopted in previous studies mainly consisted of traditional foods without further processing. Recently, a prepackaged LRD for Special Medical Purpose was specifically designed for bowel preparation. This trail was to compare the impact of the prepackaged LRD on bowel preparation for colonoscopy with self-prepared LRD by patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients whose age is between 18-65.
* Patients who have indications for screening, surveillance and diagnostic colonoscopy.
* Patients who have signed inform consent form

Exclusion Criteria:

* subjects who had known or suspected heart failure, stroke or renal failure;
* subjects who had a history of colon surgery or inflammatory bowel disease;
* subjects who Patients with had digestion or absorption dysfunction or any dietary restriction due to various reasons;
* subjects who had a history of hypersensitivity to any ingredients of laxatives or soy products;
* subjects who had high risk factors for bowel preparation such as chronic constipation, Body Mass Index (BMI) greater than 30 or BMI less than 18 Kg/m2, diabetes, spinal cord injury, or use of medications affecting bowel motility within a week;
* subjects who had participated in another interventional clinical trial in the previous 60 days;
* pregnant or lactating women and those planning to become pregnant.
Strategies for Maintenance Therapies in Advanced Non Small Cell Lung Cancer

In France, lung cancer is responsible for more than 30000 each year. Progress was made in treatment of lung cancer in the last five years due to targeted therapies and to strategical evolutions consisting in a best adjustment of treatments. Maintenance strategies is one of this strategical evolution. It is based on maintaining continuous therapeutical pression in order to preserve the therapeutical benefit obtained by the first line (induction chemotherapy). Several clinical trials showed that maintenance strategies increase the duration of controlled disease.

There is two types of maintenance strategies:

* Continuous maintenance : prolongation of the treatment initially associated with platin until progression
* Switch maintenance : introduction of a new treatment after the end of induction chemotherapy

The aim of this study is to compare two maintenance strategies

* A continuous maintenance by pemetrexed
* A switch maintenance or a continuous maintenance according to the response of induction chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Non-squamous NSCLC histologically or cytologically confirmed
* Stage IV with a cytologically or histologically confirmation for an unique metastasis
* No EGFR activating mutation or indeterminate EGFR mutational status
* At least one measurable lesion
* Age between 18 and 70
* PS 0 or 1

Exclusion Criteria:

* squamous cell lung cancer, small cell lung cancer , neuroendocrine cell lung cancer
* Knowledge of ALK gene rearrangement
* Symptomatic central nervous system metastases or requiring immediate cerebral radiotherapy
* Superior venous cave syndrome except if treated by implantation of a prosthesis
* Previous anti-tumoral treatment
* Concomitant radiotherapy
Effect of Palonosetron on Remifentanil for Preventing Emergence Cough in Female

The primary purpose of this study is to investigate the optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia in female patients who receive the palonosetron or not.

Remifentanil is a potent ultrashort-acting opioid, with rapid onset and offset of drug effect. It allows rapid anesthetic emergence even after a prolonged infusion, and decreases the at-risk time during extubation. In addition, cough suppression of remifentanil enables smooth extubation with reduced complications. However, the infusion of remifentanil suppresses the emergence cough effectively in clinical practice, whereas it still delays the awakening from anesthesia, resulting in prolonged emergence time. Reduced Ce of remifentanil during emergence would decrease the adverse events that are associated with remifentanil infusion.

Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

* BMI \> 30 kg/m2, respiratory infection, uncontrolled hypertension
Post-marketing Safety Surveillance of Qizhi Tongluo Capsules:a Registry Study.

This registry aims to monitor the safety of Qizhi Tongluo Capsules and to identify the potential risk factors for its adverse drug reactions.


Eligibility Criteria:
Inclusion Criteria:

* Patients who use Qizhi Tongluo Capsules in the monitoring hospitals.

Exclusion Criteria:

* None
Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.

This is a single center, prospective, randomized controlled study. The primary objective of this study is to measure migration over two years with RSA. Patients will be randomized in two arms, receiving a Taperloc Complete Reduced Distal or a Taperloc Complete Microplasty hip stem.

A total of 50 patients will be enrolled into the study, randomized 1:1. All patients will receive a G7 limited hole acetabular cup with E1 liner.

All potential study subjects will be required to participate in the Informed Consent process.

Eligibility Criteria:
Inclusion Criteria:

* Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and rheumatoid arthritis.
* Correction of functional deformity.
* Male or female

  -≥ 18 and ≤ 70 years of age
* Subjects willing to return for follow-up evaluations.
* Subjects able to read and understand Dutch language.

Exclusion Criteria:

* active Infection (or within 6 weeks after infection)
* Sepsis
* Osteomyelitis
* Uncooperative patient or patient with neurologic disorders who are incapable of following directions
* diagnosed Osteoporosis or Osteomalacia
* Metabolic disorders which may impair bone formation
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
* Vascular insufficiency, muscular atrophy or neuromuscular disease.
Drug Interaction Study Between Antimalarial and Anti-HIV Medications

The purpose of this study is to find out whether taking certain anti-HIV medicines with certain antimalarial medicines affects the amount of the medicines in the blood.

The study medicines that will be used are artemether/lumefantrine (antimalarial medication) and lopinavir/ritonavir or efavirenz (anti-HIV medications). Artemether/lumefantrine is not approved by the United States Food and Drug Administration (FDA) but is recommended as standard of care medical treatment for malaria in Africa and Asia. Lopinavir/ritonavir and efavirenz are approved by the FDA. Artemether/lumefantrine and lopinavir/ritonavir or efavirenz may need to be used together to treat children in Africa and Asia. We seek to learn about whether or not the use of these medicines together results in a change in blood levels of any of these medicines. The information obtained from this study will help doctors to provide a better treatment to children and adults with malaria and HIV.

The study involves 5 non-consecutive overnight stays and 14 additional outpatient visits at the San Francisco General Hospital Research Center.

Eligibility Criteria:
Inclusion Criteria:

* Absence of HIV infection prior to study entry
* Within 20% (+/-) of ideal body weight and must weigh at least 50kg
* Healthy subjects without evidence of acute or chronic illnesses, including diabetes, high blood pressure, coronary artery disease, psychiatric illnesses, liver or kidney impairment

Exclusion Criteria:

* Use of illicit drugs or alcohol that could interfere with the completion of the study.
* Use of any over- the- counter or prescribed drugs unless approved by the principal investigator or study physician.
* Pregnant or breast- feeding.
* History of acute or chronic illnesses, such as diabetes, high blood pressure, coronary artery disease, psychiatric illnesses, liver or kidney impairment.
* Evidence of acute illness.
* Family history of congenital prolongation of QTc interval or with any conditions known to prolong QTc interval, such as cardiac arrhythmias, bradycardia or severe heart disease
* History of electrolyte abnormalities.
Rapid PCR to Guide Antibiotic Therapy at the Time of Prostate Biopsy

The study is a randomized controlled trial. Subjects are randomly assigned 1:1 to receive either rapid multiplex qPCR (intervention) prior to standard of care prostate biopsy or standard of care (control) prostate biopsy. The subjects will have a rectal culture swab performed prior to the prostate biopsy. One rectal culture swab will be used for rapid multiplex qPCR and the other swab will be sent to microbiology for a standard culture. The subjects randomized to the intervention group will have the qPCR results shared with the physician to determine if additional standard of care antibiotics are needed at time of standard of care prostate biopsy. The subjects randomized to the control group will not have the qPCR results shared with the physician to determine if additional standard of care antibiotics are needed at time of standard of care prostate biopsy. Approximately, 10 days after the prostate biopsy, the research staff will conduct a chart review and/or telephone call to ask about any prostate biopsy infections and complications.


Eligibility Criteria:
Inclusion Criteria:

* Be able to give informed consent
* Be age 50 or older
* Recommended to undergo a prostate biopsy
* No allergy or side effect to fluoroquinolone antibiotics
* No history of prostate biopsy infection
* No hepatic or renal insufficiency in which fluoroquinolone antibiotics are contraindicated.

Exclusion Criteria:

* Unable to give informed consent
* Age \< 50
* Not recommended to have prostate biopsy
* Allergic to or have side effects to fluoroquinolone antibiotics
* History of prostate biopsy infection
* Hepatic or renal insufficiency in which fluoroquinolones antibiotics are contraindicated.