cyrilzakka/clinical-trials huggingface dataset:
Efficacy of External Application of Rosemary Oil in Patients With Chemotherapy-Induced Peripheral Neuropathy: a Feasibility Study

Chemotherapy can cause sensory disorders in the hands and feet called peripheral neuropathy. Typical symptoms are pain, loss of sensation, tingling, numbness, and gait disturbances, which worsen patients' quality of life and increase the risk of falls. Little is known about the effect of rosemary oil (applied to hands and feet) on the symptoms of neuropathy. The present study is a feasibility study to see if it is possible to conduct a clinical trial in patients diagnosed with cancer and receiving chemotherapy who report peripheral neuropathy and apply rosemary oil to their hands and feet.

Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common severe dose-limiting side effects that accompany treatment with different chemotherapeutic agents. Patients with CIPN often experience a reduction in quality of life and an increase in fall risk due to symptoms such as pain, sensory loss, paresthesia (tingling, numbness), and gait disturbances. Treatment of CIPN is based on pharmacotherapy, which may in turn cause side effects such as nausea, dizziness, fatigue and others. In addition, various approaches from integrative medicine are used, e.g. acupuncture, touch therapies, mind-body medicine, dietary supplements, and aromatherapy. Little is known about the effect of rosemary oil, applied to hands and feet, on CIPN. The present study is a feasibility study to determine the feasibility of a future clinical trial to investigate the efficacy of topical application of rosemary oil in cancer patients undergoing chemotherapy who develop CIPN.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age 18 years or older
* Cancer diagnosis
* Assignment to neurotoxic chemotherapy that has not yet started at the time of enrolment
* Intact, irritation-free skin on the hands and feet
* No history of neuropathic pain

Exclusion Criteria:

* Neurorelevant comorbidities such as diabetes or alcohol abuse
* Use of medication for neuropathy such as gabapentin, pregabalin, venlafaxine or duloxetine
* Other relevant treatments for CIPN during the study
* Insufficient knowledge of the German language
* History of rosemary oil allergy
PHP Home Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization (CNV)

The primary objective of this study is to assess the ability of the PHP \& HPHP to detect newly diagnosed non treated Chorodial neovascularization (CNV) lesion associate with advanced age related Macular Degeneration (AMD) and differentiate them from Early/intermediate/GA AMD

the study is prospective, multi-center, comparative

The PHP is a class I FDA approved Device ( K050350 )

Eligibility Criteria:
Inclusion Criteria:

* Patients with AMD related lesions:

Newly diagnosed (up to 6 months) non-treated CNV patients secondary to AMD in the study eye, or GA patients or Early and Intermediate AMD patients.

* Age ³ 50 for AMD patients
* VA with habitual correction in study eye 6/60 or better
* Mental and physical ability to perform a PHP/HPHP test
* Subject able and willing to sign consent form and participate in study
* Subject is not participating in another study when conducting the test

Exclusion Criteria:

* Evidence of macular disease other than AMD or Glaucoma in the study eye.

  * Presence of any significant media opacity that precludes a clear view of the macular area as identified by biomicroscopy, fundus photography, or fluorescein angiography in the study eye
  * Any non-macular related ocular surgery performed within 3 months prior to the study in the study eye
  * CNV patient inability to tolerate intravenous fluorescein angiography
The PLE²NO Self-management and Exercise Program for Knee Osteoarthritis

The PLE²NO (in Portuguese Education and Exercise Free Program for osteoarthritis) is a self-management and exercise program specific for elderly with knee osteoarthritis (OA), with the goals of managing OA symptoms, improving physical fitness, and developing self-efficacy and self-management of pathology.

Participants were randomly assigned to one of two groups: (1) Self-management and Exercise (2) Educational. Both groups received glucosamine and chondroitin sulfate supplement during the intervention. Blinding of participants was not possible due to the nature of the intervention; however, assessors were blinded to group allocation. The PLE2NO (in Portuguese Education and Exercise Free Program for osteoarthritis) is a community-based program with two components: self-management and exercise. Each session lasted 90 minutes, and the first 30 minutes corresponded to a self-management part and the remaining 60 minutes to the exercise program. The program was offered in a group format, encouraging peer interactions and socialization that can help counteract feelings of depression and isolation. The self-management program is based on the program developed at Stanford University, the Chronic Disease Self-Management Program which the purpose is developing self-efficacy based on social cognitive theory. The exercise program comprised both health related (strength, flexibility) and skill-related (agility, balance, speed and power) physical fitness components, and was based on Fit an Strong Program, on Exercise for People with Arthritis (FEPA) and also on the program Takin Control with Exercise (Arthritis Foundation). The program will last for 3 months and 6 months of follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Age over than or equal to 60 years;
2. Bilateral or unilateral OA of the knee diagnosed according to clinical and radiological criteria of the American College of Rheumatology (ACR)(Altman et al., 1986);
3. Independent mobility;
4. and reading and writing knowledge.

Exclusion Criteria:

1. Not be involved in another intervention program (exercise, education or physical therapy;
2. Do not use supplements (chondroitin sulfate and / or glucosamine) for at least three months;
3. Have other pathology (cardiovascular, respiratory, musculoskeletal, cancer) that prevents physical exercise;
4. Mental / psychological state hindering understanding of the program;
5. Having undergone surgery for knee replacement or going perform this surgery in the next eight months;
6. Being allergic to shellfish;
7. Have made injections of corticosteroids or hyaluronic acid in the last 6 months
Effect of Fertility-sparing Therapy of Early Endometrial Cancer

The purpose of this study is to investigate the effect of Fertility-sparing Therapy of Early Endometrial Cancer.

This is a prospective, multi center, open, randomized, controlled clinical trial. All endometrial cancer (EC) or atypical hyperplasia (AH) patients who met the fertility-sparing indications in the hospitals involved in this study were recruited. Then the investigators conducted assessment, treatment and follow up according to the standard procedure. General information, therapeutic regimen, side effects, oncological and pregnant results were collected for risk factors analysis.

Eligibility Criteria:
Inclusion Criteria:

* ages of no more than 40
* with a strong desire of fertility preservation
* International Federation of Gynecology and Obstetrics (FIGO) 2009 stage Ⅰa grade 1\~2 with lesion confined in endometrium
* pathology expression of progestin receptors (PRs) and estrogen receptors

Exclusion Criteria:

* not eligible for pregnancy or delivery
* evidence of suspected extrauterine or distant metastasis
* complicated with any other malignancy
* severe medical complications
* contraindication of oral progestin
* uncontrolled epilepsy, central nervous system disease or mental disorder history in patients which Influence clinical research compliance judging by the researcher.
Mesenchymal Stem Cells in Knee Cartilage Injuries

Induction of autologous repair chondrogenesis to regenerate injured articular cartilage using bone marrow mesenchymal stem cells (MSCs) after in vitro expansion under restricted culturing conditions.

Fourteen patients from both genders, age range 40-68, will be enrolled according to strict inclusion and exclusion criteria, divided into two equal groups based upon receiving autologous MSCs alone, or MSCs supported by platelet lysate through percutaneous injection.

The patients are followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (MRI) of the injected knee.

The investigators hypothesize that the two groups will give satisfactory clinical outcomes, but the investigators are looking forward to assessing the best product that will activate chondrogenesis and heal cartilaginous injury.

Eligibility Criteria:
Inclusion Criteria:

* MRI must show moderate/severe articular injury
* Serum collagen II must be above the normal value.
* Lesion site: Femoral and Tibial condyles or patella
* Admission of steroid , NSAID, pain killers must be stopped before 1 month

Exclusion Criteria:

* Lesion size
* PT and PTT not within normal value
* Complete blood count ( Hb, PCV, and RBC) not within the normal value
* HIV and Hepatitis Antigens (B and C) detection
Native Alignment in the Setting of an Arthritic Knee in Total Knee Arthroplasty

The goal of this clinical trial is to learn if preparing the target alignment of the operative side in total knee arthroplasty (TKA) based on the non-arthritic side will give the patient better overall alignment, function, and improved results compared to basing our implant alignment and positioning off the arthritic side, which is currently the traditional method.

The main questions it aims to answer are:

* Will a patient have improved postoperative TKA results if the implant alignment is based off the non-arthritic side compared to the standard arthritic side?
* What are the similarities or differences between study arms with respect to final implant alignment and positioning angles? Researchers will compare the outcomes of two cohorts of patients undergoing primary robotic-assisted total knee arthroplasty (RA-TKA) with normal contralateral knee. Based on preoperative CT imaging, the researchers will use normal contralateral side joint numbers as the target alignment for one group (Experimental arm) and utilize the traditional method for the other group (Active comparator arm). Clinical outcomes and patient-reported outcome measures (PROMs) will be compared between groups.

Participants will:

* Be randomized into one of two study arms and will receive either a unilateral knee CT or bilateral knee CT preoperatively
* Follow-up in the clinic at 2 weeks, 6 weeks and 1-year postoperatively, per standard-of-care for x-ray and clinical evaluation.
* Complete postop questionnaires (PROMs) at the prescribed follow-up intervals


Eligibility Criteria:
Inclusion Criteria:

1. Patient age is 21-89 at time of surgery
2. Patient is indicated to undergo a unilateral primary TKA, secondary to osteoarthritis
3. Patient's contralateral knee is non-arthritic
4. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document
5. Patient is able to read and speak English.

Exclusion Criteria:

1. Patient is under the age of 21
2. Patient's primary diagnosis is not osteoarthritis
3. Patient is unable to read and speak English
4. History of previous DVT/PE
5. History of stroke, CABG, or A fib
6. Current smoker
Post-market Clinical Follow-up Study With Magnetic Resonance Imaging Conditional Guide Wire

This is post-market clinical follow-up study on 25 consecutive patients in two centers to evaluate the safety and performance of magnetic resonance imaging conditional guide wire and the acceptability of identified risks in the clinical evaluation and to detect emerging risks on the basis of factorial evidence.The procedure will be done in patients with a clinical indication for cardiac magnetic resonance and conventional catheterisation.

This is post-market clinical follow-up study on 25 consecutive patients in two centers to evaluate the safety of a guide wire conditional for use in magnetic resonance imaging and the acceptability of identified risks in the clinical evaluation and to detect emerging risks on the basis of factorial evidence.

The guidewire is used to access the patients central circulatory system and in particular for the introduction and exact placement of a pressure catheter to measure the pressure gradient over the aortic arch. The procedure will be done in patients with a clinical indication for cardiac magnetic resonance and conventional catheterisation.Patients need to have a body weight over 40 kg and the introduction of a 5 French catheter should be possible. The primary endpoint is the measurement of procedural success, defined as successful insertion, steerability and visibility in MRI, in the absence of device related adverse events such as damage to vessel wall. In addition structural integrity of the instruments is to be assessed.

Eligibility Criteria:
Inclusion Criteria:

* patients with clinical indication for cardiac magnetic resonance and conventional diagnostic catheterisation
* patients with body weight of \> 40 kg in which the introduction of an introducer of \> 5 French is possible.
* subject provided written informed consent using the approved consent form or in case of a minor the subject provided written assent and its legal guardian provided written informed consent.

Exclusion Criteria:

* major surgery in the last 42 days
* history of irreversible bleeding disorder
* contraindication to cardiac magnetic resonance
* Contraindications to guidewire procedures, such as evidence of active infection
* women of child-bearing potential who cannot provide a negative pregnancy test
* chronic total occlusion.
Paclitaxel in Treating Patients With AIDS-Related Kaposi's Sarcoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with AIDS-related Kaposi's sarcoma.

OBJECTIVES:

* Determine whether the body distribution and plasma clearance of paclitaxel is affected by protease inhibitors (e.g., indinavir, ritonavir, saquinavir mesylate, or nelfinavir mesylate).

OUTLINE: Patients are stratified according to protease inhibitor treatment (yes vs no), prior paclitaxel (yes vs no), and prior doxorubicin or daunorubicin (yes vs no).

Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 2 weeks for at least 1 course in the absence of disease progression or unacceptable toxicity. Patients who previously received paclitaxel receive no more than 1 course during this study.

PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed Kaposi's sarcoma requiring chemotherapy and/or currently being treated with paclitaxel
* Serologic diagnosis of HIV infection documented by a positive ELISA and confirmed with a Western Blot or other federally approved HIV diagnostic test

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count at least 1,000/mm \^3(with or without the use of colony-stimulating factors)
* Platelet count at least 50,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST no greater than 2.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN

Renal:

* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance greater than 60 mL/min

Neurologic:

* No greater than grade 2 peripheral neuropathy
* No neuropsychiatric history or altered mental status that would preclude study

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other prior or concurrent malignancy except curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
* No sensitivity to E. coli-derived proteins
* No active untreated infection
* No new infectious complications requiring a change in antibiotics within the past 2 weeks

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 1 week since prior radiotherapy
* No prior radiotherapy to marker lesions
* No concurrent radiotherapy

Surgery:

* Not specified

Other:

* At least 2 weeks since prior systemic treatment for Kaposi's sarcoma
* At least 2 weeks since prior nonapproved FDA investigational agents except available Investigational New Drugs that are antiretroviral agents
* Concurrent maintenance therapy for opportunistic infections allowed
* Concurrent commercially available antiretroviral therapy allowed
EXperimental Paradigm to Investigate Expectation Change in Depression 4

Research has shown that people with depressive symptoms maintain negative expectations even if they have positive experiences that contradict their expectations. Healthy people, however, change their expectations after unexpected positive experiences. In this experimental study, it will now be examined whether there are also differences between healthy people and people with depressive symptoms in dealing with unexpected negative experiences.

Research has already shown that people with depressive symptoms continue to hold on to negative expectations even if they have positive experiences that contradict their expectations. By contrast, healthy people change their expectations after unexpectedly positive experiences. In this experimental study, the authors will now examine whether there are also differences between healthy people and people with depressive symptoms in processing unexpectedly negative experiences. It is hypothesized that people with depressive symptoms change their expectations in a negative direction after unexpectedly negative experiences, while healthy people continue to hold on to an optimistic view.

Eligibility Criteria:
Inclusion Criteria (clinical sample):

* diagnosis of major depression
* at least 18 years old
* sufficient German language skills

Exclusion Criteria (clinical sample):

* participation in previous studies on changes in expectations

Inclusion Criteria (healthy sample):

* at least 18 years old
* sufficient German language skills

Exclusion Criteria (clinical sample):

* participation in previous studies on changes in expectations
* current diagnosis of any mental disorder
* diagnosis of major depression in the past
* currently receiving psychotherapeutic treatment
Effects of Moderate Physical Activity on Diabetic Adhesive Capsulitis: A Randomized Clinical Trial

The study is designed to determine the effects of moderate physical activity on adhesive capsulitis in patients with uncontrolled diabetes mellitus.

This study aims to investigate the effect of additional Physical activity programmes in patients with Diabetic Frozen Shoulder (DFS).

Physical activity can help people with diabetes achieve a variety of goals, including increased cardiorespiratory fitness, increased vigour, improved glycemic control, decreased insulin resistance, improved lipid profile, blood pressure (BP) reduction and maintenance of weight loss Frozen shoulder syndrome, also known as adhesive capsulitis, is a clinical entity that refers to a stiff and painful shoulder causing major functional impairment. It affects women more than men, and is mostly associated with diabetes mellitus as a systemic condition. . Frozen shoulder may be either primary idiopathic or secondary to a systemic disease, such as diabetes mellitus.

The adoption and maintenance of physical activity are critical for blood glucose management and overall health in individuals with diabetes. In this Position Statement, we provide a clinically oriented review and evidence based recommendations regarding physical activity and exercise in people with type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria :

1. The male and female physically active with uncontrolled diabetic (\>6.5% HBA1c) patients those taking medicine to controlled it from more than 3 years.
2. The age of the participants will be between 40 to 65-years,
3. having stage 1 or 2 adhesive capsulitis (AC) with a capsular pattern included in the study.

Exclusion Criteria:

1. The patients with history of shoulder dislocation
2. Lower limb injury,
3. Diabetic foot ulcer,
4. Diabetic neuropathy,
5. Acute or chronic heart disease,
6. Rheumatologic disorder
7. Mobility disorder and post-surgical or trauma related patients will be excluded during the screening.
Abatacept Post-marketing Clinical Study in Japan

The purpose of this study is to compare the clinical efficacy including joint damage progression and safety of Abatacept plus Methotrexate (MTX) to placebo plus MTX.


Eligibility Criteria:
Inclusion Criteria:

* MTX inadequate responder
* Biologic Naïve
* Functional class I, II or III
* ≥6 swollen and ≥6 tender joints
* C-reactive protein (CRP) ≥2.0mg/dl or erythrocyte sedimentation rate (ESR) ≥28 mm/hr
* Anti-cyclic citrullinated peptide (CCP) antibody positive
* Have erosion

Exclusion Criteria:

* Any other rheumatic disease
* Active angiitis on main organs excluding rheumatoid nodule
Atherosclerosis and Acute Ischemic Stroke Study

A significant proportion of strokes are thromboembolic in nature, arising from atherosclerotic plaque at the carotid bifurcation. It is now wellknown that inflammation plays a key role in atherogenesis and plaque destabilization. However the identification and characterization of the different inflammatory factors, as well as their relative importance, have not been clarified. This main aim of this study is to identify new risk markers for atherosclerosis and to characterize more precise methods for detection of the unstable carotid plaque with increased stroke-risk.

This project include patients with asymptomatic and symptomatic carotid stenosis \>50%. Patients with acute ischemic stroke will also be included with carotid artery stenosis \<50% (study 3). The patient group will undergo a clinical neurological examination, ultrasound of the neck-arteries and a blood sample. The majority will also have a CT-angiography of the neck arteries and a cerebral MRI or CT. Carotid plaques removed by surgery (carotid end-arterectomy) and thrombs removed by thrombectomy will undergo histological analyses.

Study 1:

Plasma markers will be analysed and compared to clinical symptoms, ultrasound assessment of the plaque, cerebral MRI (or CT).

Study 2:

Results from advanced ultrasound of the carotid plaque including assessment of plaque morphology will be compared to histology of the removed plaque. Plasma markers and clinic will be related to the findings. The correlation between the different diagnostic modalities and the histologic conclusion will be assessed.

Study 3:

This study focus on plasma markers in an acute ischemic stroke due to a carotid plaque compared to an acute ischemic stroke with a cardial embolic source. Thrombi removed from the cerebral artery by thrombectomy will undergo histological analysis and the results will be compared to plasma markers and stroke aetiology.

Eligibility Criteria:
Inclusion Criteria:

* All patients with an atherosclerotic carotid stenosis \>50% admitting one of the study centres as an in-patient or an out-patient will be considered for inclusion.
* Acute stroke patients treated with thrombectomy at Oslo University Hospital will be included even though the carotid stenosis is \< 50%.

Exclusion Criteria:

* Malign disease
* Inflammatory disease