cyrilzakka/clinical-trials huggingface dataset:
A Study in Non-squamous Non Small Cell Lung Cancer in Asian Patients

To investigate efficacy and safety of the combination with pemetrexed plus carboplatin, followed by pemetrexed in patients with advanced nonsquamous Non Small Cell Lung Cancer (NSCLC) who receive at least one dose of the induction therapy.


Eligibility Criteria:
Inclusion Criteria:

* Non-squamous cell Non Small Cell Lung Cancer (NSCLC) disease
* Clinical stage IIIB/IV or recurrent disease after surgery
* No prior systemic chemotherapy, immunotherapy, targeted therapy or biological therapy, including adjuvant therapy
* Prior radiation therapy is allowed to less than 25% of the bone marrow
* Measurable disease as defined by response evaluation criteria in solid tumors (RECIST)
* The Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate organ function
* Estimated life expectancy of at least 12 weeks

Exclusion Criteria:

* Clinically significant third-space fluid collections
* Central nervous system disease other than stable and treated brain metastasis
* More than 3 weeks interval between the surgery and enrollment request date
* Unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), for a 5 days period
* Unable or unwilling to take folic acid or vitamin B12 supplementation
* Unable to take corticosteroids.
* Serious concomitant disorder that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol
* Currently have and historically had interstitial pneumonitis (interstitial pneumonia) or pulmonary fibrosis manifested as opacity on Chest x-ray or Computed tomography (CT)
Pancreatitis - Microbiome As Predictor of Severity II

The goal of this observational study is to evaluate the orointestinal microbiome and microbial derived metabolome in patients suffering from acute pancreatitis as a biomarker for severity. The main questions it aims to answer are:

* Can the orointestinal microbiome robustly predict the course of acute pancreatitis?
* How does the microbiome impact the severity of an acute pancreatitis?

Buccal/ rectal swabs, plasma and stool is collected from patients with acute pancreatitis within 48h after hospital admission.

Despite intensive research, early prediction of the course of acute pancreatitis (AP) is still not satisfactorily possible. Results of a European multicenter study showed that the intestinal microbiome is superior to established scores as a marker of severity in patients with AP. Hereby, a classifier was established using 16 differentially abundant rectal species and systemic inflammatory response syndrome (SIRS) and achieved an AUROC of 85%. Surprisingly, all species in the severe AP group were members of taxonomic families known for their short-chain fatty acid (SFCA) production. This observation contrasts with translational pancreatitis studies in mice. Based on these publications, a clinical trial is currently being initiated to treat severe AP with SCFA (NCT06147635). However, previous well-designed RCT that analyzed the effects of probiotics in predicted severe AP resulted in a worse outcome for patients in the probiotic arm. Consequently, national and international guidelines recommend against the usage of probiotics in AP.

Collectively, more research is needed to further elucidate the role of the oro-intestinal microbiota in the development of severe AP. To validate the results of previously mentioned multicenter study and to profoundly analyze the role of microbial metabolites and the fungeome, patients with AP will be prospectively recruited.

1. Buccal and rectal swabs, stool and plasma will be obtained to analyze the orointestinal microbiome and microbial derived metabolites.
2. Centers from different continents with different ethical background and dietary habits will enroll patients to gain a more generalizable microbial profile.
3. Microbial shifts were observed between severe AP (RAC 3) and mild/ moderate severe (RAC 1+2).
4. It is expected that the microbial compositions change during the inflammatory process upon early phase of pancreatitis. To minimize this microbial alternating effect a short time frame from hospital admission to recruitment (48h) is set.

Eligibility Criteria:
Inclusion Criteria:

* Patients with initial diagnosis (\< 48h) of acute pancreatitis
* Age ≥ 18 years
* Patients able to understand/ give their written consent

Exclusion Criteria:

* Recurrent acute pancreatitis (\>2 previous episodes)
* Clinical or imaging signs of chronic pancreatitis
* Referred patients with length of hospital stay \> 48h
Cognitive Behavioral Therapy Plus Drug Treatment for Obsessive Compulsive Disorder

This study will evaluate the effectiveness of two cognitive behavioral therapies (CBTs) in treating obsessive compulsive disorder (OCD) in patients who are taking medication but still have residual symptoms.

Participants remain on their current OCD medication and are randomly assigned to receive one of two CBTs: exposure and ritual prevention or stress management therapy. Exposure and ritual prevention involves imaginal and in-vivo exposure and requires that participants refrain from ritualizing. Stress management involves relaxation, assertiveness training, and structured problem-solving. Therapy occurs twice per week for 2 months. Participants are assessed verbally by an independent evaluator and are asked to complete self-rating forms. Patients who respond are followed for up to 1 additional year. Participants continue to take the same medication and the same monthly therapy for the first 6 months of follow-up. During the second 6 months of follow-up, participants discontinue therapy but continue taking the same medication.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00389493

Eligibility Criteria:
Inclusion Criteria:

* Obsessive-Compulsive Disorder (OCD) diagnosis
* Currently taking a serotonin reuptake inhibitor (SRI, i.e. clomipramine, fluoxetine, fluvoxamine, paroxetine, sertraline, or citalopram) for OCD

Exclusion Criteria:

* Medical or psychiatric conditions that would make participation in the study hazardous
* Intensive cognitive-behavioral therapy while on an adequate dose and duration of an SRI for OCD
Outcome Assessment of an Active Surveillance Program for Low Risk Prostate Cancer: An Observational Study

The purpose of this research study is to monitor the feasibility and outcome of the Active Surveillance Program for men with low risk prostate cancer.

The purpose of this observational study is to prospectively monitor the outcome associated with men who meet the eligibility criteria for low risk prostate cancer and elected to participate in the active surveillance program at The Center for Cancer Prevention and Treatment at St. Joseph Hospital. We hope to demonstrate that men who are compliant with a closely monitored active surveillance program for low risk prostate cancer will achieve favorable outcomes by: 1) avoiding the side effects of definitive therapy that may not be necessary; 2) retaining quality of life (QOL) and normal activities; 3) avoiding unnecessary treatment; and 4) decreased health care costs. In addition, we will monitor the possible adverse outcomes that may be associated with the active surveillance program including suboptimal response and/or greater side effects due to delayed initiation of therapy; psychological impact on the patients and caregivers due to anxiety of living with an untreated cancer and/or the requirement for frequent medical examination and periodic prostate biopsies.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Histological documented adenocarcinoma of the prostate either newly diagnosed or previously diagnosed. Subjects who are diagnosed more than 3 months prior to time of enrollment in the active surveillance program must have biopsy repeated.
* PSA \< 10 ng/ml within 1 month of program enrollment
* Clinical stage less than or equal to T2a
* Biopsy sampling with at least 10-12 cores
* Gleason score less than or equal to 3 + 3
* No more than 2 cores involved
* No core more than 50% involved
* Eligible for definitive therapy
* Able to provide informed consent
* Able to complete a QOL questionnaire
* Able to comply with the scheduled follow-up appointments

Exclusion Criteria:

* See inclusion criteria for eligibility
Trial of S-1 Plus Cisplatin in Gastric Cancer

The purpose of this study is to evaluate the effectiveness and safety of s-1 plus cisplatin versus 5-FU plus cisplatin as first-line therapy in the treatment of patients with advanced gastric cancer.

This is a randomized, controlled, open-label,multicenter study. Patients are randomized to one of two treatment arms : S-1 plus cisplatin and 5-FU plus cisplatin.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease.
* Male or female.
* Age 18 -75.
* Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study).
* Measurable disease, according to the Response Evaluation Criteria in Solid Tumours(RECIST)
* ECOG Performance status 0, 1 or 2
* Haematological, Biochemical and Organ Function: Neutrophil count \>2.0 × 10 9/L, platelet count \> 100 ×10 9/L. Serum bilirubin\< 1.5 × upper limit of normal (ULN); or, AST or ALT \< 2.5 × ULN (or \< 5 × ULN in patients with liver metastases); or, alkaline phosphatase\< 2.5 × ULN (or \> 5 × ULN in patients with liver metastases,Creatinine clearance \> 60 mL/min.
* Signed informed consent.

Exclusion Criteria:

* prior adjuvant/neoadjuvant therapy more than two regiments.
* Received any investigational drug treatment within 30 days of start of study treatment.
* Patients with active gastrointestinal bleeding.
* Neurological toxicity ≥ grade 2 NCI-CTCAE.
* Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
* History or clinical evidence of brain metastases.
* Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.
* Pregnancy women.
* Subjects with reproductive potential not willing to use an effective method of contraception.
* Patients with known active infection with HIV.
* Known hypersensitivity to any of the study drugs.
Phase III Trial of Adjuvant Chemo-radiotherapy After D2 Surgery of Gastric Cancer

The purpose of this study is to explore the efficacy of adjuvant radiotherapy for D2 resected gastric cancer

The radiotherapy dose of 45Gy in 25 fractions as adjuvant treatment after D2 surgery for gastric cancer

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-75；
2. Had histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction；
3. ECOG 0-1；
4. Subjects has to voluntarily join the study and sign the Informed Consent Form for the study;
5. D2 and R0 resection;
6. Locally advanced (UICC stage, T4, N2, N3) gastric cancer after surgery;
7. More than 15 lymph nodes;
8. Adequate organ function as defined below: Hematologic ANC ≥ 2\*109/L, Platelets ≥ 100\*109/L, AST and ALT ≤ 2.5×ULN, TBIL ≤ 1.5×ULN.

Exclusion Criteria:

1. Previous radiotherapy or chemotherapy；
2. Inadequate organ function;
3. Pregnant or lactating women or women of childbearing potential.
Exercise in Advanced Parkinson's Disease (PD) With Deep Brain Stimulation (DBS)

This project is a 3-month prospective study assessing the immediate and long-term changes associated with aerobic exercise in quality-of-life measures, nonmotor scores, brief neuropsychological batteries, and local field potentials (LFPs) in those with Parkinson's Disease (PD) who have undergone deep brain stimulation (DBS) surgery for management of their symptoms. In this study, the investigators will assess the feasibility of an aerobic exercise regimen in those with advanced PD and DBS, characterize the immediate and long-term changes in neuronal activity with exercise in PD, and assess the nonmotor impact of exercise in individuals with advanced PD and DBS.

The investigators will recruit individuals who are not regular exercisers and develop an individualized 3-month exercise plan with the assistance of physical therapists, using heart rate targets for moderate exercise. Outcomes will be measured at baseline and following 3-months of regular exercise. Field potentials will be noted at baseline, during exercise every 2 weeks, and then a final baseline at the end of 3 months in on-medication and on-stimulation states. This will allow for characterization of field potential changes over time both during exercise as efficiency improves as well as impact on baseline neuronal activity in the resting state. This study is novel in that most aerobic exercise studies target early PD subjects and rarely include those who have undergone DBS surgery. The study will specifically focus on the feasibility of developing an aerobic exercise regimen in those with more advanced disease as well as gathering preliminary data on the impact it will have on motor and nonmotor features in this cohort. In addition to the clinical outcomes, investigators are now able to capture neuronal activity with novel FDA-approved DBS technology, allowing us to non-invasively monitor real-time changes in the basal ganglia in those who have undergone DBS surgery. This study will also aim to characterize baseline neuronal activity in this cohort and monitor for changes that occur during exercise as well as determine if there is a change in baseline neuronal activity as exercise tolerance improves and with consistent, regular aerobic exercise.


Eligibility Criteria:
Inclusion criteria:

* Individuals with Parkinson's Disease
* Age \>18
* H\&Y stage 1-3 in the medication on and stimulation on state
* History of STN DBS
* Able to tolerate exercise from a cardiovascular, cognitive, and orthopedic perspective
* Not on beta-blockers, as we will be using heart rate-based targets
* Stable medication and stimulation for 60 days prior to baseline visit
* Access to exercise equipment

Exclusion criteria:

* Medical comorbidities that preclude safe exercise per the discretion of the principal investigator
* Regular exercisers
Extraocular Muscle Stretching as a Weakening Procedure

Interventional case series. Non-operated patients with an indication of medial rectus muscle weakening surgery (deviation up to 20 PD) who could cooperate with topical or sub-Tenon's anesthesia. Clinical workup includes routine complete ophthalmological evaluation. One double needle 6/0 Mersilene suture is used on each side of the muscle at 4 mm distance of the insertion and pulled / stretched to insert in the sclera 3-5 mm posterior to the muscle locking passes.

Seven patients with esotropia of 12-20 PD were included.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring weakening of medial rectus muscle(s) for 12-20 PD of esotropia who could cooperate with topical / sub-Tenon's anesthesia, and had no previous eye muscle surgery

Exclusion Criteria:

* Patients with previous strabismus surgery
Investigating Muscle Repair in Response to Icing Therapy Post Eccentric Muscle Damage Exercise

The purpose of our research is to investigate the effects of applying cold therapy, or "icing," to injured muscles in terms of strength recovery and muscle soreness amelioration following unaccustomed exercise.

The objective is to determine whether or not injured muscles that are subject to icing after eccentrically damaging exercise recover their strength quicker and/or have less muscle soreness than those that do not receive any icing treatment after damaging exercise and if any differences in effectiveness between two icing protocols exist. Baseline measures of peak torque of the dominant arm's elbow flexor muscles will be measured by concentric and isometric contractions prior to participants undergoing eccentric muscle damaging exercise. Participants will be randomly assigned into 3 different experimental groups of approximately 15 participants each. The first group will begin "Icing Protocol 1" at time 0 (or as close to). The second group will begin "Icing Protocol 2" six hours after their initial eccentric muscle damaging exercise. The remaining group will not receive any icing treatment; they are the control group. Participants will be brought back into the lab at specific post-exercise times (0h, 24h, 48h, 96h, and 7 days) to complete peak torque measures as they did with baseline measures prior to eccentric muscle damage. Measures of delayed onset muscle soreness (DOMS) will also be taken at baseline and during scheduled follow up times for participants.

Eligibility Criteria:
Inclusion Criteria:

* Healthy students attending Wilfrid Laurier University with no previous history of upper body muscle damage and live in close proximity to the University so they can attend all lab sessions. Ideally they have not performed any upper body resistance training within the last 4 months.

Exclusion Criteria:

* Previous history of muscle, joint, or ligament injuries in the surrounding area of their dominant are elbow flexor region.
Comparison of Two Multi-Purpose Solution and Lens Material Combinations on Corneal Barrier Function

The purpose of this study is to measure the relative "barrier" function of the top layer of the cornea (called the epithelium), or the degree to which the cornea can prevent the penetration of the colored dye sodium fluorescein into the eye. This is a clinical investigation of the effect on corneal barrier function following wear of two contact lens materials and two contact lens care systems, approved for marketing in the US by the Food and Drug Administration. These contact lenses will be worn for two hours, following soak in one of two marketed contact lens disinfecting solutions. Approximately 25 young, adapted contact lens wearers will participate.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age.

  * Understand your rights as a research subject and give written informed consent by signing the Informed Consent Form, Subject Bill of Rights, and Patient Authorization for Use and Release of Health and Research Study Information (HIPAA form).
  * Be likely to finish the entire study, understand the study instructions, and be willing to follow the instructions.
  * Contact lens prescription between +4.00 D to -9.00 D (spherical equivalent).
  * Best correctable visual acuity of at least 20/40 in each eye.
  * Willing to de-adapt (do not wear) from habitual contact lenses for periods of three days prior to barrier function determination.
  * Possess a functional spectacle prescription to allow adequate vision during the de-adaptation and barrier function determination periods.
  * No known ocular or systemic allergies, which may interfere with contact lens wear.
  * No known systemic disease, or need for medication that may interfere with contact lens wear (i.e. antihistamines, beta-blockers, steroids).

Exclusion Criteria:

* Subjects demonstrating any medical condition that may affect the results of this study SHOULD NOT be enrolled. The following are specific conditions that exclude subjects from enrollment in this study.

  * Eye (ocular) or systemic allergies that may interfere with contact lens wear.
  * Less than one month successful, full time (defined as more than 8 hours per day, and more than 5 days per week) soft lens wear.
  * Systemic disease or uses of medication, which may interfere with contact lens wear.
  * Clinically significant corneal swelling (greater than grade 3 or 4 on a 0-4 scale), corneal blood vessel growth) (vascularization), corneal staining, bulbar redness, tarsal redness, or any other abnormality of the cornea that may cause unsafe contact lens wear.
  * Any active ocular infection.
  * Prior corneal refractive surgery (i.e., LASIK, PRK, etc).
  * Have used medications within 24 hours of study entry or have an ongoing need to use ocular medication.
  * Are taking part in any other study or have taken part in a study within the last 14 days
  * Have a medical condition that your study eye doctor thinks may make it not appropriate for you to participate in this study.
  * Are pregnant, or anticipate becoming pregnant during the course of this study.
TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children

Primary objective:

* To demonstrate the efficacy of a Bacillus clausii probiotic strain compared to placebo in children suffering from acute diarrhoea and treated for 7 days.

Secondary objective:

* To evaluate the clinical safety of the Bacillus clausii probiotic strain versus placebo.


Eligibility Criteria:
Inclusion criteria:

Infants or Children

* Non hospitalized infants or children
* With acute diarrhea evident for less than 48 hours
* Having had three or more watery stools during the preceding 24 hours

Exclusion criteria:

Infants or Children

* With blood stools
* Having been treated with antibiotics or probiotics within the two weeks before the enrollment
* Suffering from dehydration defined by a weight loss of at least 5% or by the presence of a skin fold
* With an history of seizures
* With immunosuppressive conditions
* With a current status requiring an antibiotic treatment
* Suffering from a chronic disease including chronic diarrhea whatever the origin
* Having received before inclusion one of the following treatments:

  * Probiotics
  * Prebiotics
  * Drugs with adsorbing properties
  * Drugs that modify intestinal secretion like bismuth subsalicylate, acetorphan
  * Drugs that modify intestinal motility (opiates such as loperamide, atropine and other cholinergic agents).
* Having participated in another clinical trial in the last 3 months prior to the start of the study
Comparison of Thyroid Volumes in Patients With and Without Endometrioma

The aim of our study is to evaluate whether there is a statistical difference between thyroid gland volume in patients with pathological diagnosis of endometriosis or endometrioma and in patients who underwent surgery for other gynecological reasons, and to reveal the presence of concomitant thyroid disease in these cases.

Transcripts and proteins involved in thyroid metabolism are dysregulated in the eutopic and ectopic endometrium of endometriotic patients, leading to triiodothyronine (T3) action, resistance, and local thyroxine (T4) accumulation of the ectopic endometrium. Thyroid stimulating hormone (TSH) acts as a proliferative and prooxidative hormone in all endometriums of endometriosis patients and controls. Mouse studies have confirmed that endometriotic implants are larger when thyroid hormones are increased.

Since endometriosis is characterized by a chronic inflammatory process, the high prevalence of autoimmune thyroid diseases in patients with endometriosis may be the result of immune dysregulation observed in women with endometriosis (5). Thyroid involvement has already been described in the physiology of the endometrium and ovary, and thyroid diseases are often associated with gynecological and obstetric disorders such as infertility, miscarriage or preterm delivery.

Despite all the links between thyroid diseases and endometriosis, there is no study related to thyroid volume in patients with endometriosis so far. Thyroid volume was studied in patients with diabetes mellitus, pregnant women, and scleroderma. We believe that the evaluation of thyroid volume in patients with endometriosis will contribute to the investigation of the relationship between these two pathogenesis, and to the treatment and follow-up approach.

Eligibility Criteria:
Inclusion Criteria:

* Prediagnosis of surgically planned endometrioma

Exclusion Criteria:

* Patients with goiteri,
* Patients with past or present autoimmune thyroid dysfunction,
* Patietns on treatment with thyroid hormones or drugs containing iodine.