cyrilzakka/clinical-trials huggingface dataset:
Hemoglobin-to-red Blood Cell Distribution Width Ratio and Hypothermia for Elderly Patient

As individuals age, they often enter a phase of increased "frailty." Elderly and frail patients represent a population that requires heightened sensitivity and close monitoring during surgical procedures. This study aims to investigate the relationship between the Hemoglobin-to-Red Blood Cell Distribution Width (Hb/RDW) ratio and perioperative hypothermia in elderly patients undergoing transurethral prostatectomy. This is an observational study. Preoperative blood test results and intraoperative body temperature measurements of the patients will be recorded in our data forms.


Eligibility Criteria:
Inclusion Criteria:

* Patients who provided informed consent.
* Patients scheduled for transurethral prostatectomy surgery.
* Patients classified as ASA-PS 1, 2, or 3.
* Male patients aged 65 years or older.
* Patients undergoing elective surgery.
* Patients receiving general anesthesia.

Exclusion Criteria:

* Patients who did not provide informed consent.
* Patients undergoing emergency surgery.
* Patients with conditions that disrupt thermoregulation (e.g., intracranial mass, peripheral vascular diseases, sepsis).
* Patients with a body temperature of \<34℃ or \>38℃ upon arrival at the preoperative waiting room.
* Patients who used heating methods other than the routine cotton cover in the preoperative waiting room.
* Patients who received additional heating methods other than the routinely applied intraoperative hot air blower drapes.
* Patients undergoing surgery under any type of anesthesia other than general anesthesia.
* Patients who were taken out of the operating room while intubated.
Effect of Topical Brimonidine on Post Cataract Surgery Corneal Edema

Most patients undergoing cataract surgery suffer from corneal edema after the surgery.

Brimonidine drops are a well known and safe Anti-glaucoma medication. the investigators have made several clinical observations that patients receiving Brimonidine drops had a faster resolution of their corneal edema even if they had normal intra-ocular pressure.

The investigators believe that administering topical Brimonidine to patients with significant post operative corneal edema will hasten the resolution of their corneal edema.

Most patients undergoing cataract surgery suffer from corneal edema after the surgery which temporarily reduces their visual acuity until corneal edema resolves over several weeks Brimonidine drops are a well known and safe Anti-glaucoma medication, used to lower intra ocular pressure.

there have been several clinical observations that patients receiving Brimonidine drops had a faster resolution of their corneal edema even in the presence of normal intra-ocular pressure.

The investigators postulated that administering topical Brimonidine to patients with significant post operative corneal edema will hasten their recovery and visual improvement.

In order to prove that Brimonidine drops contribute to faster resolution of cornel edema and visual improvement, the study will randomly compare 50 post cataract surgery patients (group A)who will be administered Brimonidine to 2 control groups (50 people in each group):

group B will be given topical timolol drops 0.5% (another well recognized anti glaucoma medication which reduces intra-ocular pressure by different mechanism than Brimonidine.

Group C will not be given any test drug. All 3 groups will receive the regular post operative medications which include corticosteroids and antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* 1 day after uneventful cataract surgery
* corneal edema (grade 2 to 3)

Exclusion Criteria:

* glaucoma
* higher than normal intraocular pressure (\>23 mm Hg)
* known sensitivity or contra indication to brimonidine
* known sensitivity or contra indication to timolol
* pre operative corneal or anterior segment disease
* intraoperative complications
* major ocular pathology other than corneal that reduced vision (retinal degeneration, optic neuropathy etc.)
* pregnant women
* children
A Detailed Look At What Patients Experience In Medullary Thyroid Cancer Clinical Study

Clinical studies, with a distinct emphasis on medullary thyroid cancer, play a pivotal role in evaluating the safety and effectiveness of novel treatments for this condition. These trials serve as essential tools to determine whether new medications surpass conventional therapies, providing substantial evidence to endorse their broader adoption.

The primary objective is to meticulously examine trial completion rates and voluntary withdrawals within this specific patient group. By actively participating in this observational study plays a critical role in pushing medical knowledge forward and advancing care for individuals suffering from the medullary thyroid cancer.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of medullary thyroid cancer
* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
* No serious medical or psychiatric illness likely to interfere with participation in this clinical study.

Exclusion Criteria:

* Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study
* Any serious and/or unstable pre-existing medical disorders
* Patients who are currently receiving any other investigational drug.
Assessment of Paclitaxel-Induced Neuropathy

The purpose of this study is to collect clinical data, blood samples, and self reported symptoms from patients that experience unusually severe neuropathy after treatment with paclitaxel. This data will be used to develop predictive markers for neuropathy. Blood samples will be used to create induced pluripotent stem (iPS) cells and eventually artificial nerve cells to be used to study neuropathy in the lab.


Eligibility Criteria:
Inclusion Criteria (Severe Toxicity Group):

* Diagnosis of cancer (including, but not limited to, breast and ovarian cancer)
* Females aged 18 and older
* History of grade 3 or higher peripheral neurotoxicity, any neuromotor, neurocortical, or neurocerebellar toxicity, myalgias or arthralgias refractory to non-steroidal anti-inflammatory drugs and steroids, ong-term persistence (\> 6 months) of grade 2 or higher peripheral neuropathy, or other unusually severe neurotoxicity approved for inclusion in study by Principal Investigator after completion of paclitaxel chemotherapy regimen or history of peripheral neuropathy that required treatment with narcotics or grade 2 or higher peripheral neuropathy after only 1 to 2 doses of paclitaxel.

Inclusion Criteria (Control Group):

* History of no neurotoxicity (grade 0) after completion of a standard paclitaxel-containing chemotherapy regimen
* Females age 18 and older
* Matched to a specified subject with neurotoxicity based on age (within 10 years), tumor type, chemotherapy regimen or total paclitaxel dosage, race, and ethnicity

Exclusion Criteria :

* Treatment with other severely neurotoxic chemotherapy (i.e. cisplatin) prior to or concomitantly with paclitaxel. Carboplatin therapy is allowed.
* Presence of peripheral neuropathy prior to paclitaxel therapy
* Poorly controlled or insulin-dependent diabetes or other condition likely to predispose to neurotoxicity (alcoholism, Charcot-Marie-Tooth disease)
A Pilot Study Of SD-809 (Deutetrabenazine) In Moderate To Severe Tourette Syndrome (TS)

The purpose of this study is to evaluate safety, tolerability and preliminary efficacy of SD-809 in the treatment of motor and phonic tics of Tourette Syndrome and to evaluate the pharmacokinetic of SD-809 and its metabolites.


Eligibility Criteria:
Inclusion Criteria:

* 12 to 18 years of age, inclusive, at Screening.
* Patient has a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) diagnosis of Tourette Syndrome and has manifested motor and phonic tics within 3 months before the Screening visit
* Patient has total tic score of ≥19 on the YGTSS
* Tic severity and frequency has been stable for at least 2 weeks before the Screening visit
* Willing to adhere to medication regimen and to comply with all procedures
* Patient is in good general health, as indicated by medical and psychiatric history and physical examination
* Patient and parent/guardian have provided written, informed consent (and written assent, as appropriate)
* Female patients of childbearing potential agree to use an acceptable method of contraception

  * Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* Patient has a serious untreated or undertreated psychiatric illness
* Patient has a history of suicidal ideation or behavior
* Patient has received tetrabenazine, neuroleptics, benzodiazepines, topiramate, dopamine receptor antagonists within 14 days of Screening or Baseline; or botulinum toxin within 3 months of Screening or Baseline
* Patient is being treated with deep brain stimulation for control of tics
* Patient has a progressive or degenerative neurological disorder or a structural disorder of the brain
* Patient has participated in an investigational drug or device trial within 30 days of Screening
* Patient is pregnant or breastfeeding at Screening or Baseline
* Patient has a history of alcohol or substance abuse in the previous 12 months, as defined in the DSM-V

  * Additional criteria apply, please contact the investigator for more information
Prospective Observational Study on Plerixafor After Chemotherapy

Plerixafor is a new CXCR4 inhibitor that is able to improve peripheral blood stem cell (PBSC) mobilization when combined with granulocyte-colony-stimulating factor (G-CSF). The 'on demand' use of plerixafor at the hematopoietic recovery after chemotherapy + G-CSF may be more efficient and cost-effective, but the timing of administration and criteria for patient selection are still under investigation. We collected the data of lymphoma and myeloma patients treated with plerixafor at the hematopoietic recovery after chemotherapy + G-CSF. The decision of adding plerixafor was based on PB CD34+ cells at the time of hematopoietic recovery after chemotherapy in patients at their first or subsequent attempt, according to the attending physician choice. The primary endpoint was the assessment of the rate of patients who were able to collect \>=2 x 10\^6 CD34+/kg.

Plerixafor is a new CXCR4 inhibitor that is able to improve peripheral blood stem cell (PBSC) mobilization when combined with granulocyte-colony-stimulating factor (G-CSF). The 'on demand' use of plerixafor at the hematopoietic recovery after chemotherapy + G-CSF may be more efficient and cost-effective, but the timing of administration and criteria for patient selection are still under investigation. We collected the data of lymphoma and myeloma patients treated with plerixafor at the hematopoietic recovery after chemotherapy + G-CSF. The decision of adding plerixafor was based on PB CD34+ cells at the time of hematopoietic recovery after chemotherapy in patients at their first or subsequent attempt, according to the attending physician choice. The primary endpoint was the assessment of the rate of patients who were able to collect \>=2 x 10\^6 CD34+/kg. Secondary endpoint was the assessment of the rate of patients collecting \> 4 x 10\^6 CD34+/kg and the median number of apheresis to reach the target.

Eligibility Criteria:
Inclusion Criteria:

* lymphoma and myeloma patients treated with plerixafor at the hematopoietic recovery after chemotherapy and G-CSF

Exclusion Criteria:

* patients treated only with G-CSF and plerixafor without chemotherapy
Type 3 Predictive Observational Study for Sensory Profiles in Central Sensitization in Low Back Pain Population.

This study conducts prognostic research to develop, validate, and evaluate the predictive role of sensory profiles in the development of sensory profiles over time. Therefore, a type 3 prognostic model research will be conducted in the low back pain population.

This is a longitudinal multi-centre prospective cohort study design with two measurements.The STROBE statement is used as guideline and the results are reported according to the TRIPOD, and REMARK checklists. The study is a type III prognostic model research study, following the PROGRESS framework to assess the outcome by the development, validation, and evaluation of the impact of incorporating single or multiple prognostic factors, and their prognostic value at baseline in the development of CS over a period of 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* patients with acute LBP (\< six weeks)
* with or without radiating pain
* aged 18 to 60 years
* a pain-free episode for at least 12 weeks before the onset of their current back pain.
* be able to read and understand the Dutch language.

Exclusion Criteria:

* any specific cause of low back pain
Feasibility of Ethanolization of Vein of Marshall With Specific Catheter in Atrial Fibrillation Ablation

In patients with persistent AF (PsAF), ablation limited to pulmonary vein (PV) isolation is the most straightforward approach, but results only in 50% of arrhythmia freedom at 1 year follow-up. Substrate modification strategies have failed to demonstrate their superiority with variable reported success rate. The Marshall network is a highly arrhythmogenic structure that has not been systematically targeted so far, probably because of the absence of dedicated tools to make its ablation simple and easy. We sought to investigate the use of a specific catheter for visualization and ethanolization of vein of Marshall allowing to systematically include this target in the ablation set.

The main objective of this study is to demonstrate the feasibility to use the Targeted Endovascular Delivery (TED) catheter specifically for visualization and ethanolization of vein of Marshall.


Eligibility Criteria:
Inclusion Criteria:

* Suitable candidate for catheter ablation of atrial fibrillation defined as:

  * history of symptomatic persistent atrial fibrillation
  * Redo procedure for persistent AF or paroxysmal AF with isolated PV and no history of ethanol infusion in the VOM.
* Age \> 18 years of both genders
* Patient affiliated or beneficiary of social security scheme
* Free, informed and written consent signed by the participant and the principal investigator (at least at the inclusion date and before all exams required for the clinical research)
* Effective contraception for women of childbearing potential

Exclusion Criteria:

* Minor
* Documented left atrial thrombus or another abnormality which precludes catheter introduction
* Contraindication to anticoagulation therapy (heparin, warfarin, or novel oral anticoagulant \[NOAC\]
* Contraindication to iodinated contrast product XENETIX® (iobitridol hypersensivity or at one of these excipients, history of major immediate reaction or cutaneous reaction to XENETIX® infusion, thyrotoxicosis)
* Hypersensitivity to ethanol
* Unstable angina or ongoing myocardial ischemia
* Myocardial infarction within 3 months prior to inclusion
* Congenital heart disease, where the underlying abnormality increases the ablation risk
* Severe bleeding, clotting or thrombotic disorder
* Pregnant, parturient or nursing women
* Unable or unwilling to provide written informed consent
* Patient detained by judicial or administrative order
* Patient under psychiatric care
* Patient admitted in a social or healthcare establishment for any purpose other than the research
* Subject to a legal protection order (guardianship, patient under legal protection)
A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Rheumatoid Arthritis.

The purpose of this study is to evaluate the safety and effectiveness of Infliximab (Remicade) in patients with Rheumatoid Arthritis. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce the pain of rheumatoid arthritis.

This is a randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage) trial of the safety of anti-tumor necrosis factor (TNF) chimeric monoclonal antibody (Infliximab) in combination with methotrexate (MTX) compared to methotrexate alone in patients with rheumatoid arthritis on standard disease-modifying anti-rheumatic drug background therapy. The purpose of the study is to better understand the safety and occurrence of infections in patients treated with either placebo or 3 mg/kg and 10 mg/kg of infliximab in combination with methotrexate (MTX).

Patients will receive infusions of either placebo or 3 to 10mg/kg Infliximab at weeks 0, 2, 6, and 14 then every 8 weeks through week 46.

Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. Patients will receive 3 to10mg/kg Infliximab (Remicade) or placebo via infusion at weeks 0, 2, 6, and 14 then every 8 weeks through week 46.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of Rheumatoid Arthritis at least 3 months before screening
* If the patient is of childbearing potential, must have been using adequate birth control measures
* Patients must be receiving MTX for =3 months before randomization and at a stable dose(=25 mg/week) for =4 weeks before randomization

Exclusion Criteria:

* Patients must not be pregnant, nursing, or planning a pregnancy within 18 months of enrollment
* Patients must not have rheumatic disease other than Rheumatoid Arthritis or had any systemic inflammatory condition
* Patients must not be confined to a wheelchair
* Patients must not be treated with any approved or investigational biologic agent except for approved vaccines for immunizations
Gaining Optimism After Weight Loss Surgery (GOALS) II

This randomized controlled trial examines the feasibility, acceptability, and preliminary impact of an adapted positive psychology-motivational interviewing (PP-MI) intervention for physical activity among patients who have recently undergone bariatric surgery compared to an enhanced usual care control.

This study will test a positive psychology-motivational interviewing (PP-MI) intervention for physical activity promotion in patients who have had bariatric surgery within the past 6-12 months compared to an enhanced usual care control. The investigators will enroll and randomize 58 participants. Study participation includes attending four study visits (two at baseline, one at 10 weeks, and one at 24 weeks). Participants will be randomized either to a 10-week physical activity intervention that includes once-weekly phone calls, a written manual, and a Fitbit activity tracker, or provision of the Fitbit alone. Primary outcomes include the feasibility and acceptability of the intervention. Secondary outcomes include changes in physical activity and other psychological, behavioral, and physiological outcomes at 10 and 24 weeks compared to the control.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age 18+)
* History of bariatric surgery (gastric bypass or sleeve gastrectomy) at one of two academic medical centers within the past 6-12 months
* Interest in increasing physical activity
* Low physical activity, defined as \<200 minutes/week self-reported moderate- to-vigorous physical activity
* Access to telephone for study sessions
* Able to read and speak English

Exclusion Criteria:

* Cognitive deficits precluding participation or informed consent
* Illness likely to lead to death in the next 6 months
* Inability to be physically active (e.g., severe arthritis)
* Participation in another program targeting physical activity besides their standard offerings at the surgery center.
* Severe psychiatric condition limiting ability to participate (e.g., psychosis, active substance use disorder)
An Analysis of the Improvement and Quality of Life Trends for UK/ROI Patients Treated With Cosentyx (Secukinumab) in a Retrospective Analysis of the BADBIR Data Source

This was a retrospective, observational study of psoriasis patients treated with secukinumab, using secondary data from BADBIR. BADBIR is a UK/ROI pharmacovigilance registry that was initiated in 2007 to monitor the long-term safety of biologic drugs used to treat psoriasis. The study used longitudinal data within the registry to track the trends relating to the disease. For the analysis of improvement and patient reported QoL, patients with a minimum of one follow-up visit were included. The index date was defined as the date of initiation of secukinumab treatment, and follow-up visits were at 6-, 12-, 18-, \& 24-months post-index.

The BADBIR data was current up until the 31st August 2019 for this analysis.

Study period: From 1st July 2015, as secukinumab was included in BADBIR in January 2016 and patients backdated 6 months, to 31st August 2019.

Identification period: From 1st July 2015 to 31st August 2019 was used to identify applicable patients for analysis.

Index date: Initiation of secukinumab treatment within the BADBIR database.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for the biologic cohort:

* Age ≥18 years at initiation of secukinumab.
* At least one follow-up visit post-registry enrollment.
* On-label dosing of secukinumab of 300mg.

Inclusion criteria for the PsA biologic cohort:

* Age ≥18 years at initiation of secukinumab.
* At least one follow-up visit post-registry enrollment.
* On-label dosing of secukinumab of 300mg.
* Diagnosis of PsA at baseline.

Exclusion Criteria:

- The patient did not meet the criteria stated above.