cyrilzakka/clinical-trials huggingface dataset:
Surgery and Intrapleural Docetaxel in Treating Patients With Malignant Pleural Effusion

RATIONALE: Giving drugs, such as docetaxel, directly into the pleura after surgery to drain the pleural effusion may help keep fluid from building up again.

PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of intrapleural docetaxel given after surgery in patients with malignant pleural effusion.

OBJECTIVES:

Primary

* Determine the maximum tolerated dose of intrapleural docetaxel in patients with malignant pleural effusion.

Secondary

* Determine the toxicity profile of this drug in these patients.
* Determine the pharmacokinetics of this drug in plasma and pleural fluid from these patients.
* Determine the response in patients treated with this drug.

OUTLINE: This is a dose-escalation study.

Patients undergo thorascopic surgery to drain the malignant pleural effusion. An intrapleural catheter (Pleurx catheter) is then inserted for subsequent docetaxel instillation. Approximately 24 hours after surgery, patients receive docetaxel intrapleurally over 3 minutes via the Pleurx catheter. The Pleurx catheter is then clamped for 4 hours and the patient is placed in several different positions to ensure uniform distribution of docetaxel throughout the pleural cavity.

Cohorts of 3-6 patients receive escalating doses of intrapleural docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed at weeks 1 and 3 and then monthly thereafter.

PROJECTED ACCRUAL: Approximately 8-24 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed malignant pleural effusion (MPE)

  * Symptomatic disease
* Candidate for thoracoscopic surgery for treatment of MPE

  * No known or suspected ipsilateral pleurodesis that would preclude surgery
* No bilateral MPEs
* No progressive extrapleural disease that is untreatable and/or resistant to systemic treatment

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-2

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 8.0 g/dL

Hepatic

* ALT and/or AST ≤ 1.5 times upper limit of normal (ULN) (if alkaline phosphatase normal) OR
* Alkaline phosphatase ≤ 2.5 times ULN (if ALT and/or AST normal)
* Bilirubin normal
* INR ≤ 1.5

Renal

* Creatinine ≤ 1.8 mg/dL

Other

* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment
* No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
* No peripheral neuropathy \> grade 1

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No concurrent systemic chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Effectiveness of Perturbations Exercises in Improving Balance, Function and Mobility in Stroke Patients

Following stroke, patients loses functions of the motor, sensory and higher brain cognitive faculties to various degrees which lead to diminished balance. It has been documented that hemiplegic or hemiparetic stroke patients presented with more posture sway, asymmetric weight distribution, impaired weight-shifting ability and decreased stability capability. There are many balance exercises and strategies; to improve balance in elderly age group population, to prevent fall prevention. But we have very few evidences of giving manual perturbation balance training in stroke patients to improve speed, balance and function. Therefore this study is taken up to examine whether the manual perturbation balance training is more effective in improving speed, balance and function in stroke patients.

There are many more studies done for elderly populations, normal individuals for improving balance by giving perturbation based balance training.All perturbation exercises are given by either mechanical or by self reaching tasks in forward,backward,and in both sideways. There are very studies ;who attempted perturbation based balance training to improve balance in elderly population but not for stroke patients for their Speed, Balance and Function.The manual perturbation exercise can be an promising intervention in the future for various conditions

Eligibility Criteria:
Inclusion Criteria:

1. First ever stroke
2. Age ranges between 40-70
3. Both genders were included
4. Ambulatory patients with or without ambulatory aids
5. Occurrence of stroke at within 0-3 months i.e.-sub acute
6. Able to follow command
7. Mini mental scale examinations not less than 24

Exclusion Criteria:

1. Patients who has severe limitations in passive range of motion at lower extremities
2. Patients with impaired sensory, proprioceptor, cognitive and perceptual ability
3. Patient who has contracture
4. Orthopedic or any other neurological disorder which impair balance
Follow-up of Cancer Patients Receiving Immune Checkpoint Inhibitor Therapy by Electronic Patient Reported Outcomes-tool

Electronic patient reported outcome (ePRO) tools have improved survival and quality of life (QoL) of cancer patients receiving chemotherapy, and in the follow-up of lung cancer patients. Current study investigates electronic patient reported outcome tool in the follow-up of cancer patients receiving immune checkpoint inhibitor therapy.

Current study aims to evaluate 1) patient reported symptoms and their severity, 2) Number of triggered alerts by the tool and their correlation to treatment side-effects, cancer progression, other medical events or survival, 3) Correlation between different symptoms and the correlation of symptoms to treatment side-effects, cancer progression, other medical events or survival,4) QoL of patients and correlation of changes in QoL to treatment side-effects, cancer progression, other medical events or survival, 5) Patient compliance, 6) Correlation of baseline laboratory values to treatment side-effects, cancer progression, other medical events or survival.

Please see the Brief summary

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Advanced cancers
3. Immune checkpoint inhibitor therapy initiated within +/- 2wks
4. Age \>18y
5. ECOG 0-3
6. Patient compliant with the study procedures

Exclusion Criteria:

1. Immune checkpoint inhibitor therapy initiated \> 2wks ago
2. General vulnerability affecting the participation in the trial
3. No internet access
Survey About Diet in Chronic Inflammatory Rheumatic Diseases

A French Survey on patients' practices, knowledge and beliefs about diet in chronic inflammatory rheumatic diseases (rheumatoid arthritis, psoriatic arthritis, spondylarthritis) Use of a questionnaire about what patients have heard concerning diet and rheumatism, what kind of diet they tried eventually and how it affected their health and disease


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient with chronic inflammatory rheumatism (rheumatoid arthritis, spondylarthritis, psoriatic arthritis) according to the diagnostic criteria commonly admitted
* Patient followed in the rheumatology department of the University Hospital of Poitiers (France)
* Free patient, without guardianship or tutelage or subordination
* Patient not opposing to participate in the study

Exclusion Criteria:

* Patient withdrawing consent
* Patient who does not meet criteria for chronic inflammatory disease (rheumatoid arthritis, spondylarthritis, psoriatic arthritis) according to the diagnostic criteria commonly admitted after examination of medical record
A Phase III Clinical Study of KW-2246

This study is designed to assess the safety and efficacy of long-term KW-2246 treatment as rescue medication for breakthrough pain.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent to participate in the study on a voluntary basis.
* Patients who have been eligible for the confirmatory trial by meeting the inclusion criteria applicable at the time of giving written informed consent and those applicable at the time of randomization, and who have completed the confirmatory trial.
* Outpatients who live with a caregiver such as a family member, or inpatients.
* Require rescue medication at least 0.5 times (at least once every two days) but not more than three times per day on average as determined by the investigator.
* Performance Status (ECOG) of 3 or less at the time of giving written informed consent.
* Have a life expectancy of at least three months as determined by the investigator.
* Be able to receive diary training and have been able to properly complete diaries during the confirmatory trial.

Exclusion Criteria:

* Have experienced intolerable adverse reactions (as defined in Attachment 3) during the confirmatory trial.
* Have met any of the exclusion criteria applicable at the time of giving written informed consent, those applicable at the time of randomization, or subject withdrawal criteria in the confirmatory trial.
* Serious respiratory dysfunction.
* Asthma.
* Serious bradyarrhythmia.
* Serious hepatic dysfunction.
* Serious renal dysfunction.
* Susceptibility to respiratory depression due to conditions such as increased intracranial pressure, head injury and brain tumor.
* Patients who have a history of clinically significant adverse reactions to the combination of opioid analgesics and any of the following drugs/substances, and who are currently receiving or expect to receive any of them during the study:

Central nervous system depressants (phenothiazines, benzodiazepines and barbiturates), inhalation anesthetics, monoamine oxidase inhibitors, tricyclic antidepressants, skeletal muscle relaxants, antihistamines, ritonavir, alcohol, itraconazole, amiodarone, clarithromycin, diltiazem, and fluvoxamine.

* History of convulsive seizures (except a single episode of infantile febrile convulsions).
* History of hypersensitivity to fentanyl.
* Pregnant or lactating women, possibly pregnant women, or women who are planning to become pregnant.
* Patients who are judged by the investigator/subinvestigator to be inappropriate for this study.
Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia

To evaluate the recurrence and postoperative complications rates after conjunctival autograft surgery using fibrin adhesive for primary pterygium


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of primary pterygium
* Symptomatic pterygium
* Limbal invasion

Exclusion Criteria:

* Secondary pterygium
Re-Purposing the Ordering of 'Routine' Laboratory Tests in Hospitalized Medical Patients (RePORT Study)

Laboratory test overuse occurs when tests are ordered repetitively, without due consideration of impact on clinical status. Repetitive inpatient lab testing often provides limited value for patient outcomes while increasing healthcare costs, patient discomfort, and unnecessary transfusions and prolonging hospitalizations. The research study aims to reduce laboratory test overuse in hospitals through implementation of a comprehensive, multi-disciplinary, and multi-faceted intervention bundle that includes audit and feedback reports, clinician education, clinical decision support tool, and patient infographics across 14 hospitals in Alberta.

Background: Laboratory and Pathology testing contributes to rising health care expenditure. A relatively large percentage (up to 42%) of laboratory testing can be considered wasteful. Redundant testing alone has been estimated to waste up to 5 billion dollars annually in the United States of America. Laboratory over-utilization leads to false positives that promotes further inappropriate testing and procedures, interruption of normal sleep pattern of inpatients, as well as iatrogenic anemia and pain. A Canadian study showed significant hemoglobin reductions as a result of phlebotomy. Studies support the safe reduction of repetitive laboratory testing without negative effects on adverse events, readmission rates, critical care utilization, or mortality.

The aim of this research study is the following:

1. To implement a multimodal intervention bundle containing healthcare provider and patient engagement tools for hospitalized medical inpatients in 14 hospitals across the province of Alberta in Canada using a cluster randomized stepped-wedge design
2. To evaluate the impact of the intervention bundle on laboratory test utilization of six target laboratory tests (complete blood count, electrolytes, creatinine, urea, partial thromboplastin time, and international normalized ratio), costs, and patient safety outcomes.

This intervention bundle will be implemented across all the adult hospital sites in Alberta starting January 2023 and evaluated until October 2024.

Eligibility Criteria:
Inclusion Criteria:

* all participants (patients and healthcare providers) within enrolled adult hospitals in Alberta of medical and hospitalist units during study period

Exclusion Criteria:

* outside of the above-mentioned province
* hospitals not enrolled
* non-medical units (eg. ICU, surgical, pediatric, obstetrical units)
Pediatric Intensive Care Ulcer Prophylaxis Pilot Trial

This study tests the feasibility of a large study of stress ulcer prophylaxis in critically ill children. Children admitted to the Pediatric Intensive Care Unit who are expected to require mechanical ventilation for more than 48 hours will be randomized to intravenous pantoprazole 1 mg/kg or matching placebo once daily until they no longer need mechanical ventilation.

Despite sparse pediatric data on the effectiveness of stress ulcer prophylaxis to prevent gastrointestinal (GI) bleeding, 60% of critically ill children receive these medications. This may have unintended consequences - increasing the risk of nosocomial infections - which may be more serious and common than bleeding these drugs are prescribed to prevent. A large randomized trial (RCT) is needed to assess the balance of these risks and benefits, to determine if a strategy of withholding stress ulcer prophylaxis in critically ill children is not inferior to a strategy of routine stress ulcer prophylaxis. RCTs in pediatric critical care are exceptionally challenging to complete; thus, a rigorous pilot RCT is crucial. The pilot may prevent pursuit of a trial that is ultimately not feasible - which is ethically and financially responsible. It is more likely that this carefully designed pilot trial will ensure that the larger trial we undertake is successful.

Eligibility Criteria:
Inclusion Criteria:

1. less than 18 years of age
2. \>4 months of age
3. requires respiratory support in the form of invasive mechanical ventilation, non-invasive mechanical ventilation, or high-flow oxygen
4. the attending physician expects the child to require respiratory support for at least 2 more days

Exclusion Criteria:

1. histamine-2 receptor antagonist (H2RA) or proton pump inhibitor (PPI) use for \>1 week in the past month
2. active GI bleeding Blood in the nasogastric (NG) tube or coffee-ground emesis suspected by the attending physician to be from the oropharynx is not an exclusion criterion.
3. documented severe reflux, active H. pylori infection, severe esophagitis, Zollinger Ellison syndrome, Barrett's esophagus, peptic ulcer bleeding within 8 weeks
4. are receiving methylprednisolone 15 mg/kg/day or more (or equivalent) Equivalent doses: methylprednisolone, prednisone or prednisolone 15 mg/kg/day; dexamethasone 3 mg/kg/day; hydrocortisone 60 mg/kg/day
5. are receiving mycophenolate (enteral), methotrexate, nelfinavir, atazanavir, saquinavir, posaconazole
6. chronic ventilation on usual pressure settings and rate
7. nocturnal or intermittent non-invasive ventilation only
8. are eating, nursing, or if chronically fed via feeding tube, receiving usual feeds
9. received more than 1 daily-dose equivalent of acid suppressive medication in the PICU
10. were previously enrolled in this trial
11. are currently enrolled in a potentially confounding trial
12. are known to be pregnant or breastfeeding
13. are known to be allergic to pantoprazole or any other ingredient in the product
14. are not expected to survive this PICU admission because of palliative care or limited life support
Pain Sensitivity and Outcome in Arthroscopic Shoulder Surgery

The purpose of this study is to investigate whether there is a correlation between a patients pain sensitivity and their subsequent post-operative pain and surgical outcome in arthroscopic shoulder surgery.

Arthroscopic shoulder surgery is increasingly performed on a daycase basis. Optimal pain relief is the goal as this not only improves patient comfort and allows expedient discharge from hospital, but also reduces the risk of developing postoperative chronic pain and may improve surgical outcome. However, optimal postoperative pain control in daycase surgery remains a challenge. There is considerable variation in the level of postoperative pain experienced between individuals and subsequent analgesia requirements. Previous studies have attempted to predict the level of postoperative pain an individual will experience, using a variety of complex preoperative pain and psychological assessments. Other investigators have focused on a simpler approach, by testing an individual's pain threshold to a single preoperative nociceptive (painful) stimulus, e.g. heat or pressure. Recent work has produced a simple questionnaire alternative to pain intensity testing, the Pain Sensitivity Questionnaire (PSQ). We hypothesise that a patient's pain sensitivity preoperatively may both affect the level of pain they experience postoperatively and their final surgical outcome.

The aim of our study is to correlate a patient's pain sensitivity, as measured by the Pain Sensitivity Questionnaire, with the degree of acute postoperative pain (first 4 days) they experience and subsequent surgical outcome at 6 months.

Eligibility Criteria:
Inclusion Criteria:

All patients aged 18 years or older, attending for arthroscopic shoulder surgery (stabilisation, rotator cuff repair, arthrolysis, subacromial decompression), able to give informed consent.

Exclusion Criteria:

* Unable to give informed consent
* Documented sensory abnormality (e.g. peripheral neuropathy)
* Contraindication to proposed anaesthetic/analgesic regimen
* No telephone or unable to communicate in English
* Documented psychiatric disorder
* Documented/suspected substance abuse
Virtual Tai ji Quan Exercise to Prevent Falls in Older Adults

To examine two different exercise programs in reducing incidence of falls among community-dwelling older adults

This is a randomized controlled trial aimed at determining the effectiveness of a virtual and home-based tai ji quan intervention vs. a virtual and home-based multimodal exercise intervention in reducing incidence of falls among community-dwelling older adults at high risk of falling

Eligibility Criteria:
Inclusion Criteria:

* age between 65 and 90 years and
* having had 1 or more falls in the preceding 12 months or having a score ≥12 seconds on the Timed Up\&Go (TUG) test.

Exclusion Criteria:

* showing a diagnosis of dementia or significant cognitive impairment, as indicated by a score of \<24 on the Mini Mental State Evaluation (MMSE, range: 0-30);
* being unable to ambulate independently for household distances; (c) having no medical clearance;
* having participated in any regular and structured tai ji quan-based or multicomponent exercise programs (≥2 times weekly) in the preceding 6 months;
* having any physical condition that would preclude participation in moderate-intensity exercise; and
* being unwilling to commit to the duration of the intervention or accept group assignment.
The Effect of a Levonorgestrel-releasing Intrauterine Device (IUD) Versus a Copper Containing IUD on Risk of Blood Clots

This is a randomized controlled trial to assess the effect of a levonorgesterel-releasing intrauterine device (LNG IUD, Mirena®) versus a copper IUD (Paraguard®) on coagulation parameters known to be associated with risk of thrombosis (blood clots). Both the LNG IUD and the copper IUD are FDA approved devices for contraception.

Women enrolled in this study will be randomized to receive either the LNG IUD or the copper IUD. They will complete a one month bleeding diary prior to insertion of the IUD and again for one month while the IUD is in place. They will undergo phlebotomy (blood draw) at baseline (prior to insertion of the IUD), two and four months. Stored samples will be used to measure D-dimer, C-reactive protein (CRP), antithrombin (AT), factor VIIIc, activated partial thromboplastin time (aPTT) and activated partial thromboplastin time plus activated protein C (aPTT + APC). Both groups will undergo a GYN exam with screening for bacterial vaginosis and gonorrhea/chlamydia cultures prior to insertion of the IUD. A brief survey to assess the women's experience with the IUD, including symptomatology and satisfaction with the device, will be conducted at the four months after insertion.


Eligibility Criteria:
Inclusion Criteria:

* Women who desire long-term, reversible contraception

Exclusion Criteria:

* Women with coagulopathies
* History of thrombotic events
* Pregnancy
* Active pelvic infection
* Known hypersensitivity to progestin
* Undiagnosed vaginal bleeding
* Wilson's disease
* Sensitivity to copper
* Uterine anatomy that precludes insertion of an IUD
* Women with multiple sexual partners and history within the last 5 years of alcoholism or drug abuse.
* Additionally, women must be greater than 3 months postpartum and have had two months without oral contraceptive pills or 6 months without Depo Provera prior to enrollment.