cyrilzakka/clinical-trials huggingface dataset:
Geriatric Assessments in Elderly Diffuse Large B-cell Lymphoma Patients-2 (GERIAD2)

This study will validate the impact of comprehensive geriatric assessments using activity of daily living (ADL), instrumental activity of daily living (IADL), and Charlson's comorbidity index (CCI) on survival and toxicities in Korean patients with diffuse large B-cell lymphoma (DLBCL) treated with R-CHOP.


Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed CD20+ DLBCL
* 65 years old or over
* Scheduled to receive R-CHOP chemotherapy
* Informed consent

Exclusion Criteria:

* Other histology than CD20+ DLBCL
* Primary central nervous system DLBCL
* Patients with a diagnosis of cancer (other than basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, well differentiated thyroid cancer \[papillary or follicular thyroid cancer\]) within 3 years before the study entry or with any treatment for cancer within 3 years before entry
* Consent withdrawal
Impact of Craniovertebral Angle on Dizziness and Risk of Falling in Cervical Radiculopathy Patients

-The goal of this observational study is to learn about the impact of the changes in cranio-vertebral angle on the cervicogenic dizziness and the risk of falling in the patients with cervical radiculopathy .The main question it aims to answer is: Is there an impact of the changes in cranio-vertebral angle on the cervicogenic dizziness and the risk of falling in the patients with cervical radiculopathy ? The participants will be undergone measuring the cranio-vertebral angle ,assessment of cervical proprioception and other tasks and questions through 3scales .

Researchers will compare between study group and control group to see if there isimpact of the changes in cranio-vertebral angle on the cervicogenic dizziness and the risk of falling in the patients with cervical radiculopathy .


Eligibility Criteria:
Inclusion Criteria:

* The Patients will include if they have the following:

  1. Fifty patients with chronic cervical radiculopathy(degenerative type) from both sex will participate in the study (twenty five with forward head posture (FHP) , and twenty five without forward head posture (FHP) ).
  2. The duration of the disease (cervical radiculopathy)is more than 6 months.
  3. The age ranged from 35 to 50 years old.
  4. Mild to moderate neck pain on visual analogue scale .
  5. Pain and dizziness lasting for 3-6 months.
  6. subjective dizziness experienced in conjunction with cervical pain, movement, stiffness, or particular postures.

     Exclusion Criteria:
* The Patients will exclude if they exhibit any of the following:

  1. Cervical myelopathy.
  2. Cervical myelo-radiculopathy.
  3. Acute cervical radiculopathy.
  4. Diabetic neuropathy.
  5. Previous cervical surgery.
  6. Cervical trauma.
  7. Deformities in the cervical spine .
  8. Rheumatoid arthritis.
  9. Any tumours and infection involving the cervical spine .
  10. Patients with a history of neuromuscular disorders.
  11. precise diagnosis of either central dizziness (due to cerebrovascular disorders related to the vertebrobasilar circulation, migraine, multiple sclerosis, tumours of the posterior fossa, neurodegenerative disorders, some drugs, and psychiatric disorders) or peripheral dizziness( due to a problem in the part of the inner ear that controls balance. These areas are called the vestibular labyrinth, or semicircular canals. The problem may also involve the vestibular nerve. This is the nerve between the inner ear and the brain stem).
Perineal Trauma After Jet Ski Accidents and Long-term Functional Outcomes Results

French multicentric retrospective cohort study including patients who underwent an ano-perineal trauma following a personal watercraft/jet-ski accident and that were treated in France from January 2017 to December 2023.

Aims of the study were to describe the initial management of the patients and to evaluate the digestive, urological and sexual functional outcomes as well as the quality of life, using validated questionnaires commonly employed in clinical practice.

Ano-perineal injuries and their mechanisms resulting from personal watercraft (PWC)/Jet-Ski accidents are poorly understood and may lead to long-term functional repercussions, previously unmentioned in studies. These accidents are in France but, mostly, concerned young women, back-seated on the PWC without any specific protection.

Therefore, the research team conducted a French multicentric cohort study that retrospectively included patients who experienced ano-perineal trauma following a personal watercraft/Jet-Ski accident and were treated in France.

Data on pre-hospital management, pre-operative work-up, surgical management (including surgical techniques), short-term and long-term complications (routinely used functional scores) were collected through the analysis of personal medical records.

Several patients had sphincteric, rectal, vaginal, or combined injuries, sometimes requiring the establishment of a stoma. the investigators subsequently evaluated the rate of fecal incontinence (evaluated by anorectal manometry or Wexner score), urological (USP score), and sexual outcomes (FSFI). Quality of life was also assessed using the SF12 score.

Eligibility Criteria:
Inclusion Criteria:

* ano-perineal trauma following a PWC/Jet-Ski accident between January 2017 and December 2023
* managed and followed in France

Exclusion Criteria:

* \<18 years old
Follow up After Intensive Care. The FUTstudy

To investigate the effect of nurse led follow up talks to prevent posttraumatic stress (PTS) symptoms and improve quality of life and sence of coherence after an intensive care unit (ICU) stay.

Secondly:

Investigate level of psychological distress, quality of life, hope and work participation in ICU patients after an ICU stay and factors associated with these outcomes.

The ICU patient experiences total dependence on health care professionals and technical devices. Some patients report unpleasant memories such as pain, feeling helpless, or delusional experiences from the ICU stay and many report physical or mental symptoms after discharge from the ICU. Return to work rate after ICU treatment differs. Most ICU patients receive analgesics and sedatives to relieve pain and discomfort during the stay. Thus many patients have few memories from their time being critically ill. For patients with few memories from the ICU stay this represents an interruption in the patient's life history. Since personal identity is influenced by the stories we tell about ourselves, loss of memory from a period with critical illness might be experienced as a threat towards self-confidence and sense of coherence. Some patients with traumatic memories from the ICU develop PTS symptoms after discharge.

In order to help the earlier ICU patient to achieve a life with less physical and mental complaints, some ICUs have established a follow up program in outpatient clinics after discharge from hospital, but there is sparse evidence of the effectiveness of this intervention, and what type of follow up that best help the patients.

The primary aim of the study is to:

Investigate if a group of previous intensive care patients receiving nurse led follow up talks three times after discharge from the ICU have less post traumatic stress symptoms, pain, increased sense of coherence and, work participation and health related quality of life (HRQL) three, six and twelve months after discharge from the ICU compared to a control group receiving standard care.

Secondary aim:

Investigate level and predictors of anxiety, depression, PTS symptoms, hope, pain, HRQOL and work participation in intensive care patients ICU patients first year after discharge from ICU.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with an ICU stay like or above 24 hours who speak and understand Norwegian and who are conscious and cognitively oriented at the time of inclusion. Patients with a score of 25 or more on Post Traumatic Stress Scale 10 (PTSS-10) is randomized to intervention or control group. Patients with a score below 25 on PTSS-10 is included in an observation group.

Exclusion Criteria:

* severe psychiatric disorder
Association Between Hypermobility and Chronic Musculoskeletal Pain

Study hypothesis:- Benign joint hyper mobility syndrome which persists into adulthood is a special type of benign joint hyper mobility which is more likely to predispose to chronic musculoskeletal pain.

Young Indian adults aged between 25 and 40 years who are blood donors or relatives of patients admitted as inpatient or presenting to the out patient department, in Amrita Institute of Medical Sciences will be enrolled, after excluding the exclusionary criteria. They will be assessed for the presence of chronic musculoskeletal pain using a validated self filled questionnaire. The primary investigator who will be blinded to their response will examine them for the presence of Benign Joint Hyper mobility Syndrome and for tender points suggestive of fibromyalgia.

Primary Objective:- To determine whether chronic musculoskeletal pain is associated with Hypermobility among Indian adults.

Study design:- Cross sectional survey


Eligibility Criteria:
Inclusion Criteria:

1. Completed their 25th birthday
2. Not yet celebrated their 40th birthday
3. Are relatives of patients being treated in Amrita Institute of Medical Sciences or voluntary blood donors in the same institute

Exclusion Criteria:

1. Subjects who have been diagnosed previously with a inflammatory musculoskeletal disease.
2. Subjects detected to have signs or symptoms of inflammatory arthritis on a detailed clinical examination and history taking.
3. Subjects who have symptoms suggestive of diabetes mellitus or hypothyroidism or have been previously diagnosed with the same.
4. Subjects who are not willing to participate.
5. Subjects who have been diagnosed as having a connective tissue disorder or have a family history of the same.
Cytomegalovirus Reactivation in Cancer Patients Receiving Chemotherapy

Cytomegalovirus (CMV) infects most of the world population. This study is to understand if chemotherapy will increase the chance of reactivating CMV. The results may help us in determining when treatment is needed and perhaps Why is it needed.

Despite CMV reactivation has been clearly described in patients underwent transplantation, this phenomenon has not been studied in patients undergoing chemotherapy. Our purpose is to understand if CMV number increases in monocytic leukocytes during chemotherapy and how is the host response to that changes.

Virus load will be studied by quantitative PCR, host response will be studied by measuring patient's anti-CMV IgG, CMV-associated symptoms, serum IFN-r and TNF-a.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of any cancer
* chemotherapy is needed for more than 6 months
* age\>20 years old

Exclusion Criteria:

* those who do not agree to participate
Hemadsorption During and After Cardiopulmonary Bypass to Modulate the Inflammatory Response

Chronic kidney disease (CKD) is a risk factor for the development of cardiovascular disease, which increases the risk of death after cardiac surgery. High interleukin 6 (IL-6) blood levels is commonly observed in patients with CKD, and this is particularly high after cardiac surgery. High IL-6 levels are also associated with increased long-term mortality rate after cardiac surgery. To date, the use of ultrafiltration or endotoxin adsorption systems were not found to improve the clinical outcome, although able to reduce the inflammatory mediators concentrations. In the last years, a new extracorporeal hemadsorption filter (CytoSorb) has been developed for removal of inflammatory cytokines and it has been approved by the European Union. However, data lack about the impact on clinical outcome of the use of CytoSorb in patients with CKD undergoing cardiac surgery with cardio-pulmonary bypass (CPB). The investigators have therefore designed this pilot prospective randomized trial to evaluate the efficacy the intraoperative use of CytoSorb for cytokines removal to prevent the inflammatory response associated with the cardiac surgery and complications in patients with CKD.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive adult patients (age \>65 years) undergoing cardiac surgery with an anticipated CPB time duration longer than 60 minutes.
* Presence of CKD defined by a Glomerular Filtration Rate (eGFR) \< 60 ml/min/1.73 m2.
* Consent to participate to the study

Exclusion Criteria:

* emergency surgery
* acute infective endocarditis
* systemic infectious diseases
* previous kidney transplant
* need for contrast enhancement during surgery
* immunosuppressive or long-term corticosteroid therapies
* participation to other investigations.
A Clinical Comparison of Two Soft Contact Lenses

The study objective was to gather short-term clinical performance data for two soft contact lenses.

The aim of this subject-masked, non-randomized, controlled non-dispensing study was to evaluate the short-term clinical performance of a monthly sphere contact lens when compared to a daily disposable contact lens after 15 minutes of daily wear each.

Eligibility Criteria:
Inclusion Criteria:

* They are of legal age (18) and capacity to volunteer.
* They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
* They are willing and able to follow the protocol.
* They currently wear soft contact lenses, or have done so within the past two years.
* They are expected to be able to be fitted with the study lenses within the power range available.

Exclusion Criteria:

* They have an ocular disorder which would normally contra-indicate contact lens wear.
* They have a systemic disorder which would normally contra-indicate contact lens wear.
* They are using any topical medication such as eye drops or ointment.
* They are aphakic.
* They have had corneal refractive surgery.
* They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
* They are pregnant or lactating.
* They have an eye or health condition including an immunosuppressive or infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
* They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.
The Finnish Diabetes Prevention Study

The aim of this study is to clarify whether lifestyle intervention provided to people with high type 2 diabetes risk will lower the cumulative incidence of diabetes. Furthermore, the aim is to study the effect of lifestyle intervention on cardiovascular risk.


Eligibility Criteria:
Inclusion Criteria:

* impaired glucose tolerance (p-glucose 2 hours after a 75 g oral glucose load between 7.8 and 11.0 mmol/l)
* body mass index 25 or higher

Exclusion Criteria:

* diabetes (previous gestational diabetes accepted)
* other chronic disease rendering survival for 6 years
* condition or medication affecting glucose tolerance
* recent myocardial infarction
Subjective and Objective Changes in Muscle-stiffness

The purpose of this study is to investigate muscle stiffness in relation to delayed on-set muscle soreness following exercise and to investigate how well the change in muscle stiffness correlates with the subjective experienced degree of stiffness.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants aged 18-80
* Able to speak, read and understand Danish and/or English

Exclusion Criteria:

* Have performed resistance training on a regular basis during the past month
* Experience of delayed onset muscle soreness (DOMS) during the last two weeks leading up to the first test session
* Current use of analgesics
* Any current neurological, musculoskeletal or mental illnesses that could interfere with the results.
* Pregnancy
* Lack of ability to cooperate
PET Imaging to Determine the Role of PET in the Assessment of Regional Disease in Breast Cancer (PET PREDICT Trial)

The overall goal of this study is to determine how FDG-PET can be incorporated into the assessment of the axilla in the staging and treatment of women with early stage breast cancer.

A multicentre, prospective, diagnostic accuracy study will be conducted evaluating the ability of positronic emission tomography using fluorodeoxyglucose (FDG-PET) to detect the presence or absence of axillary lymph node metastases in newly diagnosed breast cancer patients with no clinical evidence of spread of disease beyond the breast.

Patients will have histologic confirmation of invasive breast cancer and will have a FDG-PET scan prior to axillary node assessment. All patients will have a sentinel node biopsy if any sentinel nodes can be located. Patients with a positive sentinel node will have an axillary node dissection. The results of the PET will be compared to the reference standard of histologic examination of all excised (sentinel and non-sentinel) axillary lymph nodes which will be referred to as axillary node assessment. Sensitivity, specificity, positive and negative predictive values for PET-FDG will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of invasive breast cancer,
* Resectable primary cancer.

Exclusion Criteria:

* The diagnosis of invasive breast cancer was made more than 3 months prior to registration,
* Patient and/or surgeon are not willing to proceed with a SNB or AND after the PET scan is completed,
* Patient and/or surgeon are not willing to proceed with a level I and II AND if the SNB is positive, if the PET scan shows increased uptake in the ipsilateral axilla, or if the surgeon is still gaining experience in the performance of SNB,
* SNB or AND has already been done,
* Chemotherapy has been given or will be given prior to PET scan or SNB or AND,
* Significant serious concurrent medical problems (e.g., uncontrolled diabetes),
* Patient is pregnant or lactating,
* Patient is unable to lie supine and with both arms above their heads for PET scan,
* Known hypersensitivity to FDG,
* Clinical evidence of regional nodal metastases (fixed, matted axillary nodes),
* Clinical evidence of distant metastases.
Study to Evaluate the Pharmacokinetics (PK), Safety, Tolerability of Single-Dose Transdermal Rotigotine in Japanese and Caucasian Healthy Male / Female Subjects

To investigate the Pharmacokinetics (PK) of transdermally delivered Rotigotine in Japanese and Caucasian Female and Male Healthy Subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject is healthy according to assessments done at eligibility assessment (medical history, physical examination, blood pressure, heart rate, Electrocardiogram (ECG), hematology, clinical chemistry, urinalysis)
* Subject is of normal body-weight as determined by a body mass index ranging between 18 to 28 kg / m²
* Subject is Japanese or Caucasian. Japanese subjects are born in Japan and left Japan not more than 10 years ago. Both parents of the Japanese subjects are 100 % Japanese

Exclusion Criteria:

* Subjects (females) without medically adequate contraception (e.g. mechanical contraception (Intrauterine-Device IUD), sterilization, hysterectomy) or on lactation or pregnant women. Subjects with oral contraception or hormone replacement within 4 weeks prior to eligibility assessment
* Subject has a history of chronic alcohol or drug abuse
* Subject has a consumption of more than 20 g of alcohol / day (amount corresponds to 0.5 l of beer / day or 0.25 l of wine / day or 3 glasses (à 2 cl) of liquor / day
* Subject has a clinically relevant allergy
* Subject has a known or suspected drug hypersensitivity in particular, to any component of the trial medication
* Subject has any clinically significant abnormality in physical examination
* Subject has a heart rate at rest less than 50 beats per minute (bpm) or more than 100 bpm
* Subject has systolic blood pressure lower than 100 mmHg or higher than 145 mmHg or diastolic blood pressure higher than 95 mmHg or lower than 60 mmHg
* Subject has an atopic or eczematous dermatitis and / or an active skin disease or skin tumors
* Subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or recent unresolved contact dermatitis
A Study of GDC-0919 and Atezolizumab Combination Treatment in Participants With Locally Advanced or Metastatic Solid Tumors

This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of GDC-0919 and atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid malignancy that has progressed after available standard therapy or for which standard therapy is ineffective, intolerable, or inappropriate. Participants will be enrolled in two stages, including a dose-escalation stage and an expansion stage.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy at least 12 weeks
* Adequate hematologic and end organ function
* Negative pregnancy test and willingness to utilize contraception among women of childbearing potential
* Locally advanced, recurrent, or metastatic incurable solid malignancy with measurable disease per RECIST v1.1
* Progression following at least one standard therapy; or standard therapy considered ineffective, intolerable, or inappropriate; or use of an investigational agent recognized as a standard of care
* For the expansion stage, histologically confirmed renal cell cancer (RCC), urothelial bladder cancer (UBC), triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), melanoma, head and neck squamous cell carcinoma (HNSCC), gastric cancer, ovarian cancer, cervical cancer, endometrial cancer, or Merkel cell cancer
* For the expansion stage, evaluable for PD-L1 expression
* Anti PD-1/PD-L1 relapsed cohorts (I and II), participants whose most recent anti-cancer therapy consisted of single-agent PD-1/PD-L1 blockade will be enrolled

Exclusion Criteria:

* Significant cardiovascular or liver disease
* Major surgery within 28 days of study drug
* Any anti-cancer therapy within 3 weeks of study drug
* Malabsorption syndrome or poor upper gastrointestinal integrity
* Primary central nervous system (CNS) malignancy or active metastases within 5 years
* Uncontrolled tumor pain
* Autoimmune disease other than stable hypothyroidism or vitiligo
* Human immunodeficiency virus (HIV), active hepatitis B or C, or tuberculosis
* Signs/symptoms of infection, or use of antibiotics within 2 weeks of study drug
* Live attenuated vaccine within 4 weeks of study drug
* Known history or predisposition to QT interval prolongation
* Prior cancer immunotherapy, specifically indoleamine 2,3-dioxygenase (IDO) or tryptophan 2,3-dioxygenase (TDO) inhibitors, T-cell costimulatory receptor agonist antibodies, or checkpoint inhibitors among certain participants
Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis

The purpose of this study is to determine if treatment with romosozumab increases bone mineral density in Japanese women with postmenopausal osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

Ambulatory, postmenopausal Japanese women with osteoporosis (defined as bone mineral density T-score of ≤ -4.00 at the lumbar spine or BMD T-score of ≤ -3.50 at the total hip, or femoral neck)

Exclusion Criteria:

* Severe osteoporosis
* Use of agents affecting bone metabolism
* History of metabolic or bone disease (except osteoporosis)
* Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
* Current hyper- or hypocalcemia
* Current, uncontrolled hyper- or hypothyroidism
* Current, uncontrolled hyper- or hypoparathyroidism