cyrilzakka/clinical-trials huggingface dataset:
First-in-human Study of S-588210 (S-488210+S-488211)

The primary objective is to evaluate the safety and tolerability of S-588210 (S-488210+S-488211) in patients with unresectable recurrent and/or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with unresectable recurrent and/or metastatic solid tumor of lung, esophageal, head and neck, mesothelioma, or bladder cancer (including urothelial cancer of renal pelvis, ureters, and urethra), who have progressed after conventional systemic therapies or have exhausted or are intolerant to existing treatment options.
2. Human leukocyte antigen (HLA)-A\*02:01-positive patients.
3. Patients who are male or female aged ≥18 years at the time of informed consent.
4. Patients with the Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 at enrollment.
5. Patients who have a lymphocyte count accounting for 15% or higher of the total white blood cell count within 28 days before enrollment.
6. Patients who provide a personally signed and dated informed consent document for participation in the study.
7. Patients with expected life-span of at least 3 months from the time of enrollment.

Exclusion Criteria:

1. Patients who are expected to require any of the following therapies between enrollment and completion of the Observation Period.

   * Anti-malignant tumor drug
   * Systemic corticosteroid (except for corticosteroid defined as the equivalent of prednisone ≤ 10 mg/day orally)
   * Systemic immunosuppressant drug
   * Radiotherapy (except for restricted radiotherapy for pain relief of bone metastasis) for the cancer(s)
   * Surgical therapy for the cancer(s)
   * Hyperthermia for the cancer(s)
   * Traditional Chinese herbal medicine with anti-tumor or immunosuppressant effect
   * Other investigational products
2. Patients who have severe concurrent hepatic impairment, renal impairment, heart disease, hematological disease, respiratory disease, or metabolic disease, with the exception of any symptoms and/or signs associated with cancer(s).
3. Patients who have known human immunodeficiency virus infection.
4. Patients with uncontrolled systemic or active infection.
5. Patients who had any diseases with the risk of sudden death within 12 months before enrollment.
6. Patients with a history or evidence of autoimmune diseases and/or immunodeficiencies.
7. Female patients who are pregnant, breastfeeding, or have a positive pregnancy test at the predose examinations.
8. Patients who are considered ineligible for this study by the investigator or subinvestigator due to any reasons, including inability to understand and follow the requirements of the study.
CLIMB: CNS Lymphoma Imaging and Molecular Biomarkers Study

A prospective imaging and translational tissue study in CNS lymphoma to enable further disease characterisation and the development of potential predictive and prognostic biomarkers.

As a single centre exploratory study, this trial will recruit patients with newly diagnosed primary CNS lymphoma and will look at the molecular aspects of the disease in the tissue collection and imaging response assessments using CCA with respect to progression free survival.

Eligibility Criteria:
Inclusion Criteria:

* Subjects capable of giving informed consent, or if appropriate, if subject's capacity is deemed limited due to CNS involvement, a consultee can provide consent on their behalf. Some patients with PCNSL may be incapable of providing their own consent due to the neurological effects of their disease. In these cases the patient will be classed as an incapacitated adult and a legal representative will be sought in accordance with English or Scottish law as applicable (see 7.2.1)
* A radiological or histological diagnosis of primary CNS lymphoma.
* Have not received prior CNS directed therapy. Prior use of steroids is permitted.
* Participants aged ≥18 years old.

Exclusion Criteria:

- Involvement of lymphoma outside of the CNS
Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery

The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate open-angle glaucoma.

The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery compared to cataract surgery only, in subjects with mild to moderate open-angle glaucoma.

Eligibility Criteria:
Inclusion Criteria:

* mild to moderate primary open-angle glaucoma
* currently treated with ocular hypotensive medication
* pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses
* subject scheduled to undergo cataract surgery

Exclusion Criteria:

* primary angle-closure glaucoma; or secondary angle closure glaucoma, including neovascular glaucoma
* retrobulbar tumor, thyroid eye disease, Sturge-Weber syndrome or any other type of condition that may cause elevated episcleral venous pressure
Phytotherapy Strategy for Sleep Disorders Related to Anxiety With a Combination of Eschscholtzia and Valerian Extracts

The aim of the study is to evaluate the effect of a one-month supplementation with Phytostandard® Eschscholtzia and valerian on the Insomnia Severity Index (ISI), in insomniac so-called adjustment subjects (occasional or short-term insomnia)

For this study, 40 patients are going to be included. They will have a supplementation of Phytostandard® Eschscholtzia and valerian, from 2 to 4 tablets per day during 28 days.

on the one hand, during the two visits (inclusion and follow-up), the investigator completes the Hamilton Anxiety Scale (HAM-A). During the inclusion visit, he completes with his patient the epworth scale.

on the other hand, patients complete ISI twice : just after the inclusion visit and just before the follow-up visit. He completes two sleep schedules, the first one during the first week of complement and the second one during the fourth.

Eligibility Criteria:
Inclusion Criteria of patients:

* Currently having sleep disorders related to an anxiety and / or having some in the last 3 months
* Having an alteration of sleep on the previous month which results in a score strictly greater than 7 according to the index of Severity of Insomnia (ISI)
* For which the investigator freely advises his patient a complement with Phytostandard® Eschscholtzia and Valerian
* For which the patient freely agrees to complement itself after advice of his doctor with Phytostandard® Eschscholtzia and Valerian
* Having been informed of the study and accepting the collection and processing of their data

Exclusion Criteria:

* Suffering from an anxiety resulting in a HAM-A score (Hamilton Anxiety Rating Scale) greater than or equal to 30
* With a score on Epworth's sleepiness scale strictly greater than 10 (suggestive of a major hypersomnia)
* Presenting symptoms of sleep apnea syndrome
* Presenting symptoms of a restless legs syndrome
* Presenting a chronic pain syndrome requiring the daily intake of analgesic(s)
* Under psychotropic treatment (neuroleptic, anxiolytic, antidepressant or hypnotic) or under treatment to alter the waking state (antihistamines, beta-blockers, some cough syrups, etc.)
Gene Transfer Clinical Trial for Duchenne Muscular Dystrophy Using rAAVrh74.MCK.GALGT2

The proposed clinical trial study of rAAVrh74.MCK.GALGT2 for duchenne muscular dystrophy (DMD) patients that will involve direct intramuscular injection to the extensor digitorum brevis muscle (EDB).

This is a phase I safety and tolerability study. Three DMD subjects will receive bilateral injections into the EDB muscle, with one EDB receiving the GALGT2 vector (rAAVrh74.MCK.GALGT2) and the other side receiving saline alone (assigned in a randomized fashion). Three subjects will receive a single gene transfer dose of 1E12 vector genomes, and patients and investigators will be blinded as to which muscle is injected with vector. Muscle biopsies will be performed at three months (12 weeks) in two subjects and at 1.5 months (6 weeks) in one subject and evaluated blindly for the expression of the GALGT2 transgene.

Eligibility Criteria:
Inclusion Criteria:

* Nonambulant subjects, age 9 or older
* Confirmed mutation in the DMD gene using a clinically accepted technique that completely defines the mutation
* A magnetic resonance image of the EDB showing preservation of sufficient muscle mass to permit transfection
* Males of any ethnic group will be eligible
* Ability to cooperate with all study procedures
* Willingness of sexually active subjects with reproductive capacity to practice reliable method of contraception (If appropriate).
* Stable dose of corticosteroid therapy (including either prednisone or deflazacort and their generic forms) for 12 weeks prior to gene transfer

Exclusion Criteria:

* Active viral infection based on clinical observations.
* The presence of a DMD mutation without weakness or loss of function
* Symptoms or signs of cardiomyopathy, including:
* Dyspnea on exertion, pedal edema, shortness of breath upon lying flat, or rales at the base of the lungs
* Echocardiogram with ejection fraction below 40%
* Serological evidence of HIV infection, or Hepatitis A, B or C infection
* Diagnosis of (or ongoing treatment for) an autoimmune disease
* Persistent leukopenia or leukocytosis (WBC ≤ 3.5 K/µL or ≥ 20.0 K/µL) or an absolute neutrophil count \< 1.5K/µL
* Concomitant illness or requirement for chronic drug treatment that in the opinion of the PI creates unnecessary risks for gene transfer
* Subjects with rAAVrh74 binding antibody titers ≥ 1:400 as determined by ELISA immunoassay
* Presence of circulating anti-Sda antibodies as determined by study approved laboratory.
* Abnormal laboratory values in the clinically significant range, based upon normal values in the Nationwide Children's Hospital Laboratory
Orem's Self-Care Deficit Theory Based Nursing Interventions for Immunotherapy Treated Cancer Patients

Objective: The aim of this study was to determine the effects of nursing interventions based on Orem Self-Care Deficiency Theory on symptom management, care needs and quality of life in cancer patients who underwent immunotherapy.

Method: The research was planned as a randomized controlled trial. The research is planned to be carried out in the Medical Oncology unit of the Health Sciences University Antalya Training and Research Hospital. It is planned to be done with 58 patients, 29 experimental and 29 control groups. Based on Orem Self-Care Deficit Theory; face-to-face patient education, giving patient education booklet, preparation of symptom management card, face-to-face and telephone counseling initiatives were planned. Patient Description Form, Supportive Care Needs Scale-Short Form, Memorial Symptom Assessment Scale, European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scale and Self-Care Strength Scale will be used to collect data.


Eligibility Criteria:
Inclusion Criteria:

* Coming to Antalya Training and Research Hospital Medical Oncology unit for treatment,
* First time taking one of the immune checkpoint inhibitors (Ipilimumab CTLA-4, Pembrolizumab PD-1, Nivolumab PD-1, Atezolizumab PDL-1),
* Speaking and understanding Turkish,
* Being literate,
* 18 Years and older
* With solid tumor,
* No communication barrier
* Being able to communicate by phone
* Individuals who agree to participate in the research.

Exclusion Criteria:

* Patients receiving other cancer treatments in combination with immunotherapy,
* Patients with Eastern Cooperative Oncology Group Performance Scale 4.
Physical Exercise and Energy Balance

This study is a randomized controlled trial, designed to evaluate the effect of structured physical exercise sessions on the spontaneous physical activity energy expenditure and caloric intake in overweight adults. The design employs a parallel three-group experimental arms: (1) a moderate exercise group (MEG); (2) a vigorous exercise group (VEG); and a control group (CG) without physical exercise sessions.


Eligibility Criteria:
Inclusion Criteria:

1. male
2. overweight

Exclusion Criteria:

1. diabetes mellitus
2. cardiovascular diseases
3. musculoskeletal injuries
Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine Transdermal Patch in Healthy Chinese Subjects

This study is to characterize the Pharmacokinetics (PK) of unconjugated and total Rotigotine after single and multiple doses of Rotigotine transdermal patch, and also to investigate the safety and tolerability of Rotigotine transdermal patch in healthy Chinese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Chinese subjects
* Healthy volunteers with normal body weight, female subject is willing to use a double contraceptive barrier method or an oral hormonal contraceptive during the entire study

Exclusion Criteria:

* Previously participated in any Rotigotine study or participated in another clinical study for an investigational drug
* History of drug or alcohol abuse within the last 2 years
* Suicide attempt or suicidal ideation in the past 6 months
* Transient ischemic attack or stroke within the last 12 months
* Current condition of epilepsy and / or seizures
* History of significant skin hypersensitivity to adhesives or other transdermal products or recently unsolved contact dermatitis
* History or present condition of an atopic or eczematous dermatitis, psoriasis and / or an active skin disease
* Female subject is pregnant or lactating
* Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's wellbeing or ability to participate in this study
* Subject has a QTcB (QT interval corrected for heart rate according to Bazett's formula) interval of ≥ 450 ms for female or ≥ 430 ms for male
* Subject has a relevant hepatic dysfunction (total bilirubin \> 2 mg / dL or alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] greater than 2 times the upper limit of the normal reference range)
* Subject has tested positive for human immunodeficiency virus antibodies (HIV)-1 / 2Ab, hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV-Ab)
* Subject has a positive urine drug screen and / or alcohol breath test on Day 1
* Subject has made a blood donation or had a comparable blood loss (\> 400 mL)
* Subject smokes or has done so within 6 months prior to Eligibility Assessment (EA)
* Subject has a clinically relevant allergy
* Subject is currently taking any medication
* Female subject is currently taking an oral hormonal contraceptive
* Subject has symptomatic orthostatic hypotension
* Subject has a pulse rate at rest less than 45 beats per minute (bpm) or more than 100 bpm
* Subject has a systolic blood pressure (SBP) lower than 100 mmHg or higher than 140 mmHg or diastolic blood pressure (DBP) higher than 90 mmHg
* Subject has a current or a history of clinically relevant motor disturbance, impairment of memory, sleep disturbance or neurodegenerative disease
* Subject has consumed more than 3 cups (more than 450 ml) of caffeinated beverages per day
* Subject's abdomen is thickly covered with hair resulting in difficulties in finding appropriate patch application sites
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics/Pharmacodynamics (PK/PD) of Ocrelizumab in Patients With Rheumatoid Arthritis

This study will evaluate the efficacy, safety and PK/PD of ocrelizumab at each dose in combination with methotrexate（MTX）in patients with active rheumatoid arthritis (RA). The data from this study will also be compared with those from a clinical study of ocrelizumab in patients with active RA that was conducted in the U.S.

This study will evaluate the efficacy, safety and PK/PD of ocrelizumab at each dose in combination with MTX in patients with active RA. The data from this study will also be compared with those from a clinical study of ocrelizumab in patients with active RA that was conducted in the U.S.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA for ≧6 months according to the revised 1987 ACR criteria for the classification of RA.
* Adult patients, ≧20 years of age.
* Receiving methotrexate at a dose of 6 to 8mg/week（oral）for ≧12 weeks, with a stable dose for the last 4 weeks before treatment.
* Positive serum RF.

Exclusion Criteria:

* Rheumatic autoimmune disease other than RA, or Significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome).Patients with secondary Sjögren's syndrome or secondary limited cutaneous vasculitis with RA are eligible.
* Functional Class Ⅳ as defined by the ACR Classification of Functional Status in RA.
* History of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or other overlap syndrome).
* Any surgical procedure (except for minor surgeries requiring local or no anaesthesia and without any complications or sequelae) within 12 weeks prior to or planned within 24 weeks after baseline.
Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants

The primary objective is to evaluate the pharmacokinetics (PK) of BIIB104 in healthy Japanese and non-Japanese participants. The secondary objective is to evaluate the safety and tolerability of multiple, oral doses of BIIB104 administered BID for 9 days, with an additional dose occurring in the morning on Day 10 in healthy Japanese and non-Japanese participants.


Eligibility Criteria:
Key Inclusion Criteria:

* For Japanese participants, was born in Japan, and biological parents and grandparents were of Japanese origin.
* For Japanese participants, if living outside Japan for more than 5 years, must not have significantly modified diet since leaving Japan.
* Non-Japanese participants must have a screening weight within ±20% of the mean value for Japanese participants.

Key Exclusion Criteria:

* Suicide attempt within the last 2 years. Participants who, in the Investigator's judgment, pose a significant suicide risk or who have suicidal ideation associated with actual intent and a method or plan in the past 6 months (i.e., "Yes" answers on items 4 or 5 of the Columbia Suicide Severity Rating Scale) will be excluded from the study.

Note: Other protocol specific inclusion/exclusion criteria may apply.
Abdominal Skeletal Muscle Compartments in Turkish Children

The aim of this study was to establish reference values for three compartments of the abdominal skeletal muscle area (psoas muscle area, paraspinal muscle area, and total skeletal muscle area) obtained from cross-sectional Computed tomography images in Turkish Children

The aim in this study is to determine reference values for Turkish children by evaluating the abdominal region skeletal muscle area (psoas muscle, paraspinal muscles and total skeletal muscle in the section) obtained from cross-sectional CT images.

Material Method of the Research The study was planned as a retrospective study. Patients under 18 years of age who are admitted to Istanbul Province Bağcılar Training and Research Hospital with acute abdominal pain or acute trauma between May 5, 2017 and May 5, 2023 and who underwent abdominal computed tomography (CT) imaging on this date of application will be scanned through the hospital information management system. Past diagnoses of these patients will be questioned and those with chronic diseases will be excluded from the study.

CT images of the patients will be retrieved from the PACS database. From the sections taken at the L3-L4, L4-L5 levels, the cross-sectional area of the psoas muscle, paraspinal muscles and the total skeletal muscles in that section will be measured using the hospital's SYNAPS system. The results will be recorded in cm2.

Eligibility Criteria:
Inclusion Criteria:

* No chronic disease
* Being under 18 years of age
* Being Turkish
* Determining that an abdominal CT was performed in the hospital records

Exclusion Criteria:

* Patients with malignancy or known chronic disease
* Patients with mental health problems
Bladder Distension for Pain Relief in Patients With Excessive Anteflexion of Uterus Undergoing Office Hysteroscopy

This study is conducted to assess whether the passive uterine straightening of the uterus by means of bladder filling is associated with less pain experienced by patients with excessive anteflexion of the uterus during office hysteroscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with excessive anteflexion of the uterus

Exclusion Criteria:

* Cervical pathology
* Previous cervical surgery
* Severe vaginal bleeding
Histopathological Analysis of Renal Biopsies With Dynamic Full-field Optical Coherence Tomography, a Comparison to Conventional Histopathological Findings in Kidney Transplant Recipients (HARBOR)

Banff classification stands as gold standard and international consensus for the identification, diagnosis and categorization of renal allograft pathology. In addition to multiple revision dedicated to the clarification and refinement of these diagnostic categories, a special attention is now dedicated to the development of automated protocols serving the use of artificial intelligence in digital pathology. To be integrated in the actual early post-transplant monitoring procedure, such original approach is considered to match various growing expectations of clinicians and pathologists regarding the future of transplant nephropathology : decrease inter-observer variability, reduce human errors and limit time-consuming analysis of kidney biopsy. Among these, an accelerated reading and access to Banff diagnostic criteria could help initiating both appropriate and immediate treatment to improve graft survival in kidney transplant recipients. Yet conventional histopathology still requires the preparation of a paraffin block, sections as well as subsequent colorations that altogether delay the final pathological diagnosis and urge the need for additional diagnostic modalities. Designed to overcome this critical limitation, the HARBOR study intends to test the performance of direct histopathological examination of fresh kidney biopsy with full-field optical coherence tomography for the identification of Banff elemental lesions and diagnostic categories.


Eligibility Criteria:
Inclusion Criteria:

* patient \> 18 years of age who received renal transplant registered in the DIVAT cohort with kidney biopsy between start study date and primary completion date

Exclusion Criteria:

* inability to perform dynamic full-field optical coherence tomography observation at the moment of kidney biopsy