cyrilzakka/clinical-trials huggingface dataset:
A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma

This study will look at whether brentuximab vedotin works and is safe in the re-treatment setting. To be in this study, patients must have already received brentuximab vedotin as treatment and have cancer that progressed (got worse) after stopping treatment.

This is a study to determine the safety and efficacy of brentuximab vedotin in subjects with classic Hodgkin lymphoma (cHL) and systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T cell lymphoma (PTCL) who experienced complete response (CR) or partial response (PR) with a brentuximab vedotin-containing regimen and subsequently experienced disease progression or relapse.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed cHL, sALCL, or other CD30-expressing PTCL
* Previously treated with brentuximab vedotin containing regimen, with evidence of objective response, and subsequent disease progression or relapse after discontinuing treatment
* Documentation of disease relapse or progression ≥6 months after the last dose of brentuximab vedotin
* Fluorodeoxyglucose positron emission tomography- (FDG-PET) avid and bidimensional measurable disease of at least 1.5 cm in longest axis as documented by radiographic technique
* Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
* Must not be pregnant and, if of childbearing or fathering potential, must agree to use 2 effective contraception methods during study and for 6 months following last dose of study drug

Exclusion Criteria:

* Previously discontinued brentuximab vedotin due to any Grade 3 or higher toxicity
* Existing Grade 2 or higher peripheral neuropathy
* Previously refractory to treatment with brentuximab vedotin
* History of a cerebral vascular event, unstable angina, or myocardial infarction within 6 months prior to first dose
* History of another malignancy within 3 years before first dose of study drug or any evidence of residual disease from previously diagnosed malignancy
* Acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis agent against GvHD
* Active cerebral/meningeal disease
* History of progressive multifocal leukoencephalopathy (PML)
* Active uncontrolled Grade 3 (per NCI CTCAE v5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to first dose of study drug
* Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study drug, unless underlying disease has progressed on treatment
Comparing Over-the-counter Dry Mouth Remedies After Radiation

The purpose of this study is to compare the effectiveness of over-the-counter remedies for dry mouth.

Xerostomia (dry mouth) is the most common late complication of radiation therapy for head and neck cancers. When patients are cured or survive for several years, xerostomia often becomes quite bothersome; it affects their quality of life. This study compares the effectiveness of seven over-the-counter remedies, 2 rinses, 3 sprays and 2 chewing gums. A computer program will make random assignments so that the patient nor the physician will choose the order in which the products are tried. The remedies will be used for one week each and at the end of each period the patient will fill out a questionaire.

Eligibility Criteria:
Inclusion Criteria:

* Suffers from Xerostomia
* Surviver of head and neck cancer that received \>5000 cGy radiation therapy \>1 year prior to study entry.
* Able to chew, rinse and swallow.
* Ages 13-99 years of age

Exclusion Criteria:

* Currently using the following medications: anorexiants, antiacne agents, Anticholinergic agents, tricyclic antidepressants, chemotherapy agents.
* Unable to complete questionnaires
Intraarticular Gold Microparticles for Hip Osteoarthritis

In a pilot study, the investigators recently showed that intraarticular metallic gold microparticles reduce knee osteoarthritis pain for up to two years and found associated significant proteomic changes in serum and synovial fluid within eight weeks. This study aim to evaluate the outcome after intra-articular injection of gold microparticles for hip osteoarthritis.

A cohort of 20 patients, aged ≥ 18 years, with pain ≥ 3 months, and Kellgren-Lawrence OA grade 2-4, will beincluded. Metallic gold 20 mg, 72.000 pieces, 20-40 µ-meter (Berlock-Micro-Implants, HumanGoldInject) (1) were injected into the hip joint using hyaluronic acid as the carrier. In total, we treated 24 hip joints. The primary outcome was the Western Ontario and McMaster Universities Arthritis Index (WOMAC).

Eligibility Criteria:
Inclusion Criteria:

* confirmed moderate hip OA (Kellgren-Lawrence grade ≥ 2), pain for more than 3 months, and maximal pain intensity VAS (Visual Analogue Scale, 0-10) ≥ 5 during the last week

Exclusion Criteria:

* exclusion criteria were 1) malignancy, 2) active infection and antibiotic treatment, 3) active treatment with steroids, biological or other anti-rheumatic medication, 4) history of chronic pain condition, 5) inability to comply with the protocol, and 6) inadequacy in written and spoken national language.
Combined PECS II and Transeversus Thoracic Plane Blocks Vs Serratus Anterior Plane Block in Modified Radical Mastectomy

The aim of this study is to evaluate the analgesic efficacy of combined ultrasound (US)-guided pectoral nerve (PECS) block II and transversus thoracic plane (TTP) block versus US-guided serratus anterior plane (SAP) block in female patients undergoing modified radical mastectomy.


Eligibility Criteria:
Inclusion Criteria:

* Female patients
* Aged 21-60 years
* ASA physical status I, II
* Scheduled for unilateral modified radical mastectomy

Exclusion Criteria:

1. Patient refusal.
2. Known hypersensitivity to local anesthetics.
3. Body mass index \> 35 kg /m2.
4. Uncooperative or psychiatric patients.
5. Infection at the injection site.
6. Coagulation disorder.
Toripalimab Combined With Definitive CCRT for LACC Patients

Cervical cancer constitutes a significant health burden for women globally. While most patients with early-stage disease can be cured with radical surgery or chemoradiotherapy, patients with high-risk locally advanced disease or with recurrent/metastatic disease have a poor prognosis with standard treatments. Immunotherapies are a rational treatment for this HPV-driven cancer that commonly expresses programmed cell death ligand-1. Toripalimab, a humanized immunoglobulin G4 monoclonal antibody against PD-1, showed promising anti-tumor efficacy in multiple solid tumors. This randomised study is evaluating toripalimab combined with CCRT versus CCRT alone for treatment-naïve LACC.


Eligibility Criteria:
Inclusion Criteria:

* more than 18 years old females
* had newly diagnosed and previously untreated locally advanced squamous cell carcinoma of the uterine cervix
* FIGO 2018 stage IB3 to IVA with no evidence of distant metastasis
* ECOG PS 0-1 without major organ failure
* signed informed consent voluntarily

Exclusion Criteria:

* previously suffered from immunodeficiency disorders
* had any condition that researchers believed to be associated with increased risk of treatment
* Previously received or currently receiving other PD-1 antibody treatments or other immunotherapies targeting PD-1/PD-L1
Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer

To goal of this clinical trial is to quantify the dose-response effects of aerobic exercise training compared to attention control on chemotherapy relative dose intensity in colon cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Histologically confirmed stage II or III colon cancer
* Completed surgical resection with curative intent
* Plan to initiate chemotherapy
* Engage in \<60 minutes per week of moderate- to vigorous-intensity structured aerobic exercise
* No planned major surgery during the study period
* Readiness to exercise, as determined by a modified version of the Physical Activity Readiness Questionnaire
* Can walk 400 meters
* Can read and speak English
* Ability to provide written informed consent
* Provide written approval by qualified healthcare professional
* Willing to be randomized

Exclusion Criteria:

* Evidence of metastatic colon cancer
* Concurrently actively treated other (non-colon) cancer
* Currently pregnant, breastfeeding, or planning to become pregnant within the next 24 weeks
* Currently participating in another study with competing outcomes
* Any other condition that, in the opinion of the investigator, would preclude participation or successful compliance with the protocol
* Any other situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol
Aquatic Verses Land Exercise to Decrease Fall Risk

Compare the effect of aquatic,land and no exercise on fall risk factors in women diagnosed with osteoporosis

Background and Purpose: Fall prevention through exercise is an ongoing goal of researchers and clinicians. This study compared the effects of aquatic exercise (AE), land exercise (LE) and no exercise (NE) on fall risk factors. Subjects: Seventy-three women, 60 or older, with osteoporosis (OP). Method: Randomized clinical trial comparing balance, posture, strength, mobility, function, falls, and quality of life. Results: Significant differences (p\<0.05) were found for participants' ratings of global change (AE and LE \> NE), tandem balance (AE \> LE) and function (LE \> AE). Joint pain and falls occurred more often during LE. Discussion and Conclusion: Participants experienced significant global improvement with both AE and LE. Less joint pain, reduced falls and improved balance were found in AE, however LE was more effective in improving functional ability at home. Clinicians should consider the individual's specific impairments and risk factors when recommending exercise programs on land or in water.

Eligibility Criteria:
Inclusion Criteria:

* age 60 or older
* diagnosed with osteoporosis
* female

Exclusion Criteria:

* has not been involved in regular exercise in past 2 months
* does not have any medical or neurological condition that would significantly limit activities of daily living, such that involvement in an exercise program would jeopardize safety
Cerebral Hemodynamics During Early Verticalization After (Successful) Thrombectomy Poststroke

This is a proof-of-concept study with a prospective observational design, where the association between progressive levels of verticalization and cerebral blood flow velocity (Ultrasound) in subacute stroke patients and healthy subjects will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* First-ever ischemic stroke in the territory of the middle cerebral artery (MCA)
* ≤12 hours after mechanical thrombectomy
* Conscious
* Hemodynamically stable
* 18 years or older
* Informed consent of the patient and/ or legal representative

Exclusion Criteria:

* Verticalization not allowed according to treating physician
* Known pre-stroke disease affecting cerebral blood flow
* Temporal bone windows insufficient to enable ultrasound penetration
* Intubation anticipated or occurred
* Venous thromboembolism
* Symptomatic intracranial hemorrhage
Evaluating the Effect of the VCD on Erectile Function and Penile Length Post RRP

The purpose of this study is to perform a randomized prospective study to evaluate whether the vacuum erection device facilitates an earlier return of erectile function post radical prostatectomy. A secondary measure will be to evaluate if the vacuum erection device can help prevent penile shortening.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a radical prostatectomy for prostate cancer who are able to attain a partial or full erection preoperatively and are sexually active.

Exclusion Criteria:

* Patients on anticoagulation therapy and those with bleeding diatheses
* Insufficient manual dexterity of patient or spouse
* IIEF(International Index of Erectile Function) at baseline \< 11, indicating severe erectile dysfunction
Ultrasound-guided Subclavian Vein Puncture Versus Cephalic Vein Dissection for Venous Access Port Implantation

The purpose of this study is to compare two different surgical techniques for implementation of totally implantable central venous access ports. Ultrasound-guided suclavian vein puncture is compared to cephalic vein dissection.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Informed consent
* Need for central venous access port implementation under local anesthesia

Exclusion Criteria:

* Impaired blood clotting
* Ongoing antiplatelet drugs therapy, except acetylsalicylic acid
* Trauma or surgical past history on both shoulder girdles
* Known central venous thrombosis (subclavian vein, upper vena cava)
* Known pneumothorax
* Septic state
* Agranulocytosis
Cognitive Remediation on Patients With Bipolar Disorder and Memory Complaints

Bipolar disorder is a major health concern. Intercritical periods are marked with residual symptoms, both thymic and cognitive, which affects quality of life of patients, but also the quality of observance. The implementation of cognitive remediation programs could be interesting. The aim of this study is to evaluate the overall performance on euthymic bipolar patients with memory complaints included in the program named "COGMED", targeting the working memory.

The impact of this program on compliance, quality of life, and memory complaints will be evaluated.

The investigator will measure whether there is a correlation between working memory and overall performances.

Finally, the investigator will try to achieve a profile of bipolar patients in whom the Cogmed program is particularly effective on a plan of overall performance.

Patients with bipolar disorder and memory complaints will be recruited.

Two visits :

1. at baseline (V0) : the investigator evaluate bipolar disorder, treatment, mood, quality of life, global functioning, and memory complaints. Patients also have a neuropsychological assessment. The COGMED program is proposed to patients with memory complaints and explain by the investigator
2. 4-6 weeks after the end of the program (11-13 weeks after V1) : the same evaluation is realized to compare score before and after the program of cognitive remediation.

Between the two visits the patient will benefit of COGMED program, at home, during 5 weeks.

COGMED is a remediation cognitive program, based on working memory, consisting on daily exercises at home on a computer.

Eligibility Criteria:
Inclusion criteria:

* Being diagnosed bipolar according to the Diagnostic and Statistical Manual of Mental Disorders - IV (DSM-IV) criteria
* Memory complaints or overall performance alterations according to the memory scale (MEM III Wechsler memory scale - third edition)
* Being euthymic at the inclusion according to Montgomery-Asberg Depression Rating Scale (MADRS \< 12) and Young Mania Rating Scale (YMRS \< 6)
* Not being treated with electroconvulsive therapy for the last year
* Not having drug-dependance or drug-abuse for the last six months
* Having a computer with internet and a cellphone at home
* Having signed informed consent
* Able to understand nature, aims and methodology of the study

Exclusion criteria:

* Patient on protective measures (guardianship or trusteeship)
* Deprived of liberty subject (judicial or administrative decision)
A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program

This is a study of tirzepatide in participants with obesity. The purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program. The study will last about 2 years (29 visits).


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 and previously diagnosed with at least 1 of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease
* History of at least one unsuccessful dietary effort to lose body weight

Exclusion Criteria:

* Diabetes mellitus
* Change in body weight greater than 5 kg within 3 months prior to starting study
* Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
* History of pancreatitis
* Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
* History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
* Any lifetime history of a suicide attempt
Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation

This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation. The patients are treated for 96 weeks after the last subject is randomized.


Eligibility Criteria:
Inclusion

* Child-Pugh (CP) score \>= 7
* Hepatitis B virus (HBV) viremia

Exclusion

* Alanine aminotransferase (ALT) \> 15 x upper limit of normal (ULN)
* Human immunodeficiency virus (HIV)/hepatitis C virus (HCV)/hepatitis D virus (HDV) coinfection
Outpatient Exclusive Human Milk Diet for Single Infant With Complex Congenital Heart Disease

A single patient observational trial to evaluate growth velocity and clinical outcomes of an infant status post cardiac surgery who has failed to grow well and demonstrated intolerance to cow milk-based and elemental formulas and fortifiers on a 100% human milk diet including a human milk based human milk fortifier formulated for term infants fluid restricted due to surgically correctable congenital conditions.

A single patient observational study to evaluate growth velocity and clinical outcomes of an infant status post cardiac surgery who has failed to grow well and demonstrated intolerance to cow milk-based and elemental formulas and fortifiers on a 100% human milk diet. Human milk is defined as expressed human milk or donor milk and its derivatives, human milk-based fortifier and human milk caloric fortifier.

The study hypothesis is that this infant if fed an exclusive human milk diet will have improved growth in part due to data greater tolerability of the diet.

It is estimated that the study will require 90 days to complete. Growth in safety observations will be collected only during the time the patient is receiving the diet.

The primary objective is to evaluate growth velocity (weight velocity \[g/kg/day\] of a single infant receiving a 100% human milk diet including a human milk based human milk fortifier formulated for term infants who are fluid restricted due to surgically correctable congenital conditions. This will be compared to the infant's growth velocity prior to the initiation of said diet.

Eligibility Criteria:
Inclusion Criteria:

* Complex congenital heart disease in presence of poor linear and head circumference growth and unable to tolerate cow's milk protein

Exclusion Criteria:

* n/a
Measurement of Endotracheal Tube Cuff

The purpose of this study is to evaluate whether the endotracheal intubation practitioners accordance to the literature knowledge of cuff pressure limits.


Eligibility Criteria:
Inclusion Criteria:

Intubated Patients

Exclusion Criteria:

No intubation Hemodynamically unstability
Docetaxel in Treating Children With Recurrent Solid Tumors

Phase II trial to study the effectiveness of docetaxel in treating children with recurrent solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

OBJECTIVES:

I. Determine the response rate to docetaxel in children with recurrent sarcomas, neuroblastomas, or brain tumors.

II. Describe the toxic effects of docetaxel in these patients.

OUTLINE:

All patients receive docetaxel with G-CSF every 21 days for up to 12 courses. Patients are followed for survival.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically verified (at original diagnosis) solid tumor that is relapsed or refractory The following histologies are eligible:
* Sarcomas: Rhabdomyosarcoma Ewing's sarcoma, Peripheral neuroectodermal tumor (PNET), Osteosarcoma, Other soft tissue sarcomas
* Brain tumors: Ependymoma Primitive neuroectodermal tumor (PNET), High grade astrocytoma, Brain stem glioma (histologic verification not required), Neuroblastoma
* Measurable disease that can be followed clinically or radiologically required
* The following not considered measurable: Bone lesions measured by bone scan or bone marrow involvement
* Central nervous system disease documented by cerebrospinal fluid cytology
* Pleural effusion

PATIENT CHARACTERISTICS:

* Age: 21 and under at original diagnosis
* Performance status: 0-3
* Life expectancy: Greater than 2 months
* In the absence of marrow involvement:
* Absolute neutrophil count at least 1,000/mm3
* Platelet count at least 100,000/mm3 (transfusion independent)
* Hemoglobin at least 9.0 g/dL (transfusion allowed)
* With bone marrow involvement:
* Absolute neutrophil count at least 750/mm3
* Red cell and platelet support possible
* Bilirubin normal
* ALT/AST less than 1.5 times normal
* Alkaline phosphatase less than 2.5 times normal
* Creatinine no greater than 1.5 times normal OR creatinine clearance or radioisotope glomerular filtration rate at least 60 mL/min
* Not pregnant or nursing
* Adequate contraception required of fertile women

PRIOR CONCURRENT THERAPY:

* Prior bone marrow transplantation allowed:
* Must have stable engraftment without need for significant blood product support or cytokine therapy
* No concurrent immunomodulating agents
* No prior paclitaxel or docetaxel At least 2 weeks since chemotherapy (4 weeks since nitrosoureas)
* No other concurrent cancer chemotherapy
* Concurrent corticosteroids allowed for intracranial pressure in brain tumor patients provided patient has been stable for at least 4 weeks
* Corticosteroids allowed as pretreatment for docetaxel
* At least 2 months since extensive radiotherapy, defined as:
* Craniospinal Volume greater than 50% of abdominopelvic cavity
* Volume greater than one third of lung volume
* No concurrent radiotherapy
* No more than 2 prior therapies and fully recovered