cyrilzakka/clinical-trials huggingface dataset:
Topotecan in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemotherapy drugs may have different effects in patients who have a poor performance status.

PURPOSE: This phase I trial is studying the side effects and best dose of topotecan in treating patients with progressive or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer with a poor performance status.

OBJECTIVES:

Primary

* Determine the maximum tolerated dose of weekly topotecan in patients with progressive or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer and a poor performance status.

Secondary

* Estimate the response rate of women with poor performance status for use in future clinical trials.

OUTLINE: This is a dose-escalation study.

Patients receive topotecan intravenously (IV) over 30 minutes on days 1, 8, 15, 22, and 29. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of topotecan 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. A total of 6 patients will be treated at the MTD.

Patients are followed periodically for up to 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer

  * Progressive or recurrent disease
* Received ≥ 1 prior course of chemotherapy
* Measurable or evaluable disease OR disease assessable by CA 125, defined as CA 125 \> normal that has increased over 2 readings \> 14 days apart
* Karnofsky performance status 10-50%
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Creatinine ≤ 1.5 mg/dL
* Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 times ULN
* SGOT ≤ 3 times ULN
* Life expectancy ≥ 12 weeks
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use accepted and effective non-hormonal contraception

Exclusion Criteria:

* Other neoplasm within the past 5 years except for nonmetastatic, nonmelanoma skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery or chemotherapy
* Septicemia, severe infection, or acute hepatitis
* Severe gastrointestinal bleeding, defined as requiring a blood transfusion or hospitalization
Static vs. Dynamic Progressive Splinting for Persistent Wrist Stiffness After DRF

This randomized controlled trial will compare the effectiveness of static progressive splinting versus dynamic splinting for treating persistent wrist stiffness in adults ≥18 years old at least 8 weeks post distal radius fracture (DRF) injury. Both splinting modalities are provided as an adjunct to one weekly supervised therapy session over a 6-week period. The primary outcomes are wrist active and passive range of motion (AROM/PROM) measured using goniometry, with secondary outcomes including patient-reported wrist function (PRWE), overall satisfaction, and adverse events.


Eligibility Criteria:
Inclusion Criteria:

Adults aged 18 years or older. At least 8 weeks post distal radius fracture (operative or nonoperative) who have completed standard rehabilitation.

Demonstrated persistent wrist stiffness with ≤50% of contralateral wrist extension or flexion.

Capable of providing written informed consent and complying with study procedures

Exclusion Criteria:

Presence of complex regional pain syndrome (CRPS) or active fracture healing issues.

History of significant wrist pathology unrelated to the DRF. Uncontrolled medical conditions that would interfere with splint application or therapy.

Known skin conditions or allergies that preclude orthosis use. Inability or unwillingness to adhere to the intervention protocol or follow-up schedule.

Pregnant or breastfeeding individuals.
Staccato Prochlorperazine in Migraine (in Clinic)

Development of Staccato Prochlorperazine for the treatment of migraine headache.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have migraine headache with or without aura (diagnosis according to International Headache Society guidelines) for at least 6 months, who have been pain free for at least 48 hours since the end of their last migraine attack, who have a pain rating of Moderate or Severe prior to dosing.

Exclusion Criteria:

* Subjects who have taken any other migraine or pain medication within 48 hours of randomization, with a history of allergy or intolerance to phenothiazines and related drugs, or are considered by the investigator, for any reason, to be an unsuitable candidate for receiving prochlorperazine, or unable to use the inhalation device, must be excluded.
Ketorolac in Breast Cancer Surgery

Do the use of Ketorolac in one intravenous injection at the moment of the operative incision reduce the number of recurrence in patient with advanced breast cancer without inflammation signs.


Eligibility Criteria:
Inclusion Criteria:

Written informed Consent age : 18-85 years weight: 50-100 kg Neutrophils / Lymphocytes ratio \>4 and/or "triple negative" histological status and/or Positive lymph nodes

Exclusion Criteria:

Previous cancer (behalf of basocellular skin cancer and in situ uterine cervix cancer) Non compliance or refusal of the protocol Positive Pregnancy test Childbearing or breastfeeding mothers Contra-indication for NSAIDs NSAIDs intake in the 5 days before randomisation NSAIDs use planned in the 30 days after randomisation Non curative surgery (T4 or M1 tumor classification )
Biologic Treatment Registry Across Canada

This registry is a multi-center, prospective, longitudinal, observational program that will gather and analyse data on participants treated with infliximab, golimumab, golimumab Intravenous (I.V) or ustekinumab. Treatment will be prescribed by the physician according to actual clinical practice or standard of care for Rheumatoid Arthritis (RA), Axial Spondyloarthritis (AxSpA) , Psoriatic Arthritis (PsA); there will be no randomized assignments to treatment. At baseline and approximately every 6 months thereafter, information will be collected to assess safety, clinical outcomes, quality of life, comorbidities, pharmacoeconomics and treatment regimens among cohorts of participants receiving infliximab, golimumab, golimumab I.V or ustekinumab for the treatment of RA, AxSpA and PsA.

Participants will be selected for this registry using a non-probability sampling method.

Eligibility Criteria:
Inclusion Criteria:

* Participant is starting infliximab, golimumab, golimumab Intravenous (I.V) or ustekinumab at the time of enrollment and is biologic naive or has been treated with only one prior biologic (including infliximab, golimumab, golimumab I.V or ustekinumab) prior to enrollment
* Participant has signed the approved informed consent form
* Participant is diagnosed with RA, AxSpA or PsA and is eligible for treatment with infliximab, golimumab, golimumab I.V or ustekinumab in accordance with routine clinical care and the Canadian Product Monograph.

Exclusion Criteria:

- Participant was treated with two or more biologics, for any period of time before enrollment
Data Collection for Patients With Low Grade Ovarian or Peritoneal Tumors

This study collects information to maintain a database on patients with low-grade ovarian or peritoneal tumors. Collecting information about the type of cancer and treatment, as well as details about follow-up care, may help researchers learn and better understand these tumor types and help develop better treatments for them.

PRIMARY OBJECTIVES:

I. To collect, both prospectively and retrospectively, data on disease characterization, treatment, and outcomes for approximately 1600 female patients with low-grade ovarian and peritoneal tumors.

II. To organize clinical information in order to support multifaceted queries of patient characteristics, treatment, and disease outcome data and to facilitate correlation of these characteristics with patient outcome.

III. To have a single data repository, kept on a secure platform that will integrate clinical information and research findings and serve as a secure archive for future research.

SECONDARY OBJECTIVE:

I. To obtain and store human tumor samples in the form of blocks or slides for the purpose of establishing a tumor bank.

OUTLINE:

Patients' medical records are reviewed for retrospective and prospective data collection. Patients may also have residual tissue samples collected and stored.

Eligibility Criteria:
Inclusion Criteria:

* Patients whose disease progressed to a higher-grade carcinoma since the time of original diagnosis:

  * Ovarian tumor of low malignant potential
  * Low-grade serous carcinoma of the ovary
  * Primary peritoneal tumor of low malignant potential
  * Low-grade serous carcinoma of the peritoneum
  * Psammocarcinoma
The Comparison of Single Incision Laparoscopic Cholecystectomy and Three Port Laparoscopic Cholecystectomy

Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery with minimal trauma. Laparoscopic cholecystectomy has been recognized since 1987 as the gold standard procedure for gallbladder surgery. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing the invasiveness of conventional laparoscopy. In this study we aimed to compare results of SILS cholecystectomy and three port conventional laparoscopic (TPCL) cholecystectomy prospectively

Single-incision laparoscopic procedures have evolved gradually to include a multitude of various surgeries. The current literature documents the use of a single-incision or single-port access surgery for cholecystectomies, adrenalectomies, splenectomies, appendectomies, herniorrhaphies, bariatrics, and colon surgery.

Total of 100 patients who undergoing laparoscopic cholecystectomy for gallbladder disorders will randomly assign to undergo SILS cholecystectomy group (n = 50) or TPCL cholecystectomy group (n= 50) according to a computer-generated table of random numbers. Demographics (ie, age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, indication for operation, need for conversion to a standard or three port laparoscopic cholecystectomy, need for conversion to an open cholecystectomy will be recorded. Outcome measures include operative morbidity, operative time, pain score, hospital stay. Morbidity will be evaluated by rates of bile leak, wound infection, hospital readmission, and hernia.

Eligibility Criteria:
Inclusion Criteria:

* Required laparoscopic cholecystectomy for gallbladder disease.

Exclusion Criteria:

* American Society of Anesthesiologists score (ASA) more than III,
* Patients had prior abdominal surgery,
* Patients admitted outside working hours with acute cholecystitis,
* Patients have choledocolithiasis,
* pregnancy,
* ongoing peritoneal dialysis,
* lack of written informed consent.
Walking Therapy In Hemiparetic Stroke Patients Using Robotic-Assisted Treadmill Training

The overall goal of this study is to determine whether robotic-assisted gait training is better than standard physical therapy treatments for improving walking ability in hemiparetic stroke patients.

Subjects enrolled into the study will be randomly assigned to one of 2 groups. The first group will receive one hour of conventional gait training, consisting of lower extremity strengthening exercises, stretching, and full weight bearing walking as tolerated, with appropriate physical assistance from a therapist. The second group will receive walking therapy using a Lokomat, which is a special treadmill that works in conjunction with 2 light-weight robotic arms that assists the subject to move their legs while they try to walk on the treadmill. Some of the subject's body-weight will be supported using a harness. During Lokomat training sessions, subjects will receive feedback of their walking performance on a computer monitor to help them walk. Both groups will be trained for 8-10 weeks, 3 times per week, for 1 hour training sessions (24 total sessions). Resources for transportation to the National Rehabilitation Hospital will be provided to all study participants.

Eligibility Criteria:
Inclusion:

* Unilateral brain lesion.
* Within 6 months post-stroke.
* Receiving no other therapy targeting function of lower limb.
* Demonstration of hemiparesis (motor dysfunction in lower limb).
* Able to walk 5 meters without therapist assistance (walking device only).
* Able to follow commands and protocol.

Exclusion:

* Significant cognitive or communication impairments.
* Uncontrolled hypertension.
* Uncontrolled diabetes.
* Clinical depression.
Cell-free DNA Methylation Markers for Cancer Screening

The purpose of this study is to evaluate the role of cell-free DNA methylation markers in cancer screening.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is average risk for development of cancer
2. Subject able and willing to undergo screening test within 90 days of enrollment
3. Subject is 40 to 74 years of age inclusive
4. Subject is able to comprehend, sign, and date the written informed consent document to participate in the study

Exclusion Criteria:

1. Subject has any condition which, in the opinion of the investigator should preclude participation in the study
2. Subject has a history of cancer
3. Participation in any "interventional" clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the subject to one or more study groups.
Effect of Dental Scaling on Helicobacter Pylori Eradication and Reinfection

Patients who had received H.pylori eradication treatment will be categorised as eradication and reinfection status and whether dental scaling has any influence on these results.

Patients over 18 years with no comorbidities especially liver, cardiac and haemorrhagic diathesis and giving informed consent will be categorised according to their status of dental scaling, eradication and reinfection rates of h.pylori.

Statistical examination will include the multiple regression and Chi-Square.

The result will emphasize the influence of dental scaling on eradication (Presence of Hp cure 1-6 months after treatment) and reinfection ( reappearance of Hp 12 months later than the treatment).

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 with h.pylori positivity and received anti-Hp treatment giving informed consent to analyse of their data on this subject.

Exclusion Criteria:

* Comorbidities with cardiac, liver and medical contraindication to perform dental scaling.
A Study of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function

This phase I study will determine the pharmacokinetic profile of patupilone in patients with mild or moderately impaired hepatic function within 2 cycles of treatment. The study population for this trial consists of patients with a documented advanced solid tumor. Patients will be stratified into 3 groups: those with normal liver function, and those with mild or moderate liver dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* World Health Organization (WHO) Performance Status score of: 0 - you are fully active and more or less as you were before your illness; 1 - you cannot carry out heavy physical work, but can do anything else; or 2 - you are up and about more than half the day, you can look after yourself, but are not well enough to work.
* Life expectancy of 3 months or more
* Patients with measurable or evaluable disease who have histologically documented advanced solid tumor and who have progressed after systemic therapy or for whom standard systemic therapy does not exist

Exclusion Criteria:

* Severe and/or uncontrolled medical disease
* Known diagnosis of human immunodeficiency virus (HIV) infection
* Presence of any other active or suspected acute or chronic uncontrolled infection
* Severe cardiac insufficiency, with uncontrolled and/or unstable cardiac or coronary artery disease
* History of another malignancy within 5 years prior to study entry, except for curatively treated non-melanotic skin cancer or cervical cancer in situ

Other protocol-defined inclusion/exclusion criteria may apply.
The Periodontal Status and Failure Rates With Different Retainer Bonding Techniques Using One-step Adhesive

The aim of this study was to evaluate fixed retainers, bonded with either direct or indirect techniques using one- or two-step adhesives, in terms of periodontal status and failure rates.


Eligibility Criteria:
Inclusion Criteria:

* Good treatment outcomes
* good oral hygiene
* No systemic or periodontal problems
* No extraction or missing anterior teeth and restorations

Exclusion Criteria:

- Patients unwilling to wear a fixed retainer
Acute and Chronic Pain in Lung Transplantation: Prevalence, Associated Factors, Taken Care

The objective of this project is to estimate the frequency and the characters of the chronic pains by a follow-up which begins during the registration on the waiting list of transplant and which ends at the end of the third year following the lung transplantation. It is a forward-looking study of prevalence entering within the framework of the common care. After lung transplant, pain will be evaluate with questionnaires every day during the hospitalisation, and then after 1 month, 3 months, 6 months, 1 year, 2 years and 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Patients benefiting from a lung transplant
* Patients on a list for a lung transplant from may 2010

Exclusion Criteria:

* Patients refusing to participate in the study
Assessing the Magnitude of Anisometropia in Patients Wearing Misight 1 Day Contact Lens

The effectiveness of Misight 1 Day Contact Lens in retarding anisometropic progression has not been investigated before. This study is aimed to elucidate the efficacy of Misight 1 Day Contact Lens for anisometropia control.


Eligibility Criteria:
Inclusion Criteria:

* 8-23 years old children diagnosed with anisometropia and are willing to accept MiSight® 1 Day contact lens wearing treatment.
* No congenital eye diseases or eye diseases such as strabismus and amblyopia.
* Those who have been stated to be willing to participate in the program for at least 24 months and accept various evaluations.

Exclusion Criteria:

* Ocular surface disease( dry eye, keratoconus..)
* Allergy to contact lens
* Received eye surgery before
* The cornea is infected (bacterial, fungal or viral infection).
* Strabismus
* Premature birth
A Study of BB-401 in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

The purpose of this study is to evaluate the safety, tolerability and efficacy of intratumoral injections with an Epidermal Growth Factor Receptor (EGFR) AntiSense DNA (BB-401) in patients with metastatic/recurrent HNSCC.


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically or cytologically confirmed HNSCC
* Failed (or are ineligible/decline to receive) all available standard therapies
* Stable, treated brain metastases
* One target lesion defined as measurable (via RECIST v1.1), with a maximum longest diameter of 4 cm, and suitable for injection
* Eastern Cooperative Oncology Group (ECOG) 0-2
* Agree to biopsies of a selected primary lesion and where possible of a second untreated lesion at baseline and end of treatment
* Ceased anti-cancer therapy for at least 3 weeks or 5 half-lives for chemotherapy based treatment regimen, or 4 weeks from any therapy with therapeutic biologicals or any type of investigational therapy

Key Exclusion Criteria:

* Nasopharyngeal Carcinoma
* Concomitant anti-cancer therapy
* Unresolved toxicities from prior treatments
* Patients in whom the indicator lesion is at risk of hemorrhage or clinically significant swelling/inflammation
Cognitive Behavioral Therapy (CBT)-Insomnia for Lung Cancer

The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is effective for insomnia in lung cancer survivors.

A randomized controlled clinical trial will be used to test the efficacy of this brief CBT-I compared to attention control on sleep, mood, functional status and quality of life in lung cancer survivors and evaluate the feasibility of translating an evidence-based CBT-I into the clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* 6 weeks from surgery for stage 1 or 2 Non Small Cell Lung Cancer
* chronic insomnia

Exclusion Criteria:

* Other preexisting sleep disorders
* Unstable medical illnesses
The Effects of Dexamethasone on the Duration of Sciatic Nerve Blocks

Dexamethasone is a commonly used steroid. This medication has been used for many years by physicians for many different indications. Recent articles, multiple case reports, and experience at this institution have indicated that dexamethasone successfully prolongs the effective duration of local anesthetics for regional blocks. This can cause a significant reduction in postoperative pain and the decreased need for postoperative narcotics. Although other adjuncts can be used for prolonging nerve blocks, epinephrine causes local vasoconstriction which can cause ischemia and nerve damage in a large nerve such as the sciatic nerve.Dexamethasone will not cause this problem and yet could prolong the duration of a sciatic nerve block. Therefore, the goal of this study is to prospectively evaluate the effectiveness of dexamethasone, both locally through the nerve block and systemically via IV administration, in prolonging the effective duration of local anesthetics when used in sciatic nerve blocks.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 yrs, male or female subjects.
* Subjects must be scheduled to undergo total knee arthroplasty under general anesthesia with consent for a femoral and sciatic nerve block post operatively for pain control.
* American Society of Anesthesiology Class 1,2,3,or 4.
* Capable of speaking and understanding English sufficiently to provide written informed consent and able to respond when asked.
* Weight \> or equal to 60kg.

Exclusion Criteria:

* Any allergies or hypersensitivity to ropivacaine or dexamethasone.
* Subject is on chronic steroids preoperatively for any reason.
* History of chronic pain syndrome (i.e. CPRS, Lumbar radiculopathy).
* History of documented or stated nerve damage or neuropathy to the surgical lower extremity.
* Contraindication to placement of sciatic nerve block.
* Sciatic block placement failure.
* Subject mistakenly receives steroids intraoperatively.