cyrilzakka/clinical-trials huggingface dataset:
A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors

The purpose of this study is to test the safety and efficacy of BMS-986482 alone and as combination therapy in participants with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy measurable by RECIST v1.1, and have received, be refractory to, ineligible for, intolerant of, or refused existing therapy(ies) known to provide clinical benefit for the condition of the participant.
* Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place, inclusive, at the time of signing the ICF.
* Participants in Part 1A may have NSCLC, SCCHN, MSS-CRC, gastric/GEJ adenocarcinoma, urothelial carcinoma, PDAC, melanoma or breast cancer (TNBC and ER+HER2-).
* Participants in Part 1B1 and 2B1 must have NSCLC and, if known, should have documented status for EGFR, KRAS, ALK, ROS1, RET, NTRK, MET exon 14 skipping mutations, and BRAF V600E.Participants must have received platinum-based chemotherapy and anti-PD-(L)1 therapy, if eligible and available.
* Participants in Parts 1B2, 2B2, and 1C must have cutaneous, acral, mucosal, or unknown primary melanoma. Participants with uveal/ocular melanoma are excluded. Participants must be melanoma 2L+.
* Participants in Part 1B3 must have advanced or metastatic MSS-CRC.
* Participants in Part 2A may have advanced solid tumors (advanced, unresectable, or metastatic NSCLC, advanced, unresectable, hormone resistant ER+HER2-breast cancer or pancreatic adenocarcinoma \[PDAC\]) based on emerging data.
* Participants in Part 2B3 must have advanced or metastatic MSS-CRC.
* For all participants in Part 1C cohort, a tumor sample from a ("fresh") biopsy \[core biopsy (at least 4 passages recommended), punch biopsy, excisional biopsy or surgical specimen\] must be obtained (obtained within 1 month of the start of the Screening, if there are tumor sites that can be biopsied with acceptable clinical risk).

Exclusion Criteria:

* History of life threatening immune mediated toxicity related to prior T-cell agonist or checkpoint inhibitor therapy, except those that are unlikely to re-occur with standard countermeasures.
* Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Identification of New Patient Stratification Tools in MSS RAS mt mCRC

This is a translational, multicentre and multinational study. The aim of this study is to identify new patient stratification tools in microsatellite stable RAS mutant metastatic Colorectal Cancer

The rational of COLOSSUS is to provide new and more effective stratification tools and therapeutic interventions, specifically tailored to MSS RAS mt mCRC patients

Eligibility Criteria:
Inclusion criteria

Patient Status

1. Ability to give signed informed consent prior to any study specific procedures and willing and able to comply with the protocol,
2. Age ≥ 18 years,
3. ECOG status of ≤ 2,
4. At least 16 weeks of life expectancy at time of entry into the study.

   Disease-related
5. Histologically confirmed stage IV MSS RAS mt mCRC as per standard diagnostic tests,
6. Unresectable and measurable disease (at least one measurable target lesion) as per clinical and radiologic criteria (RECIST v.1.1),
7. No prior chemotherapy and/or radiation therapy for CRC administered in the metastatic setting,
8. Scheduled to receive or receiving SOC chemotherapy with fluoropyrimidines and oxaliplatin +/- bevacizumab (baseline blood sample should be collected and questionnaires completed during pre-screening and before chemotherapy initiation),
9. Availability of archival formalin-fixed paraffin-embedded (FFPE) tissue from:

   1. Preferred: surgical resection of the primary or metastatic tumour

      or
   2. Biopsy samples (biopsy taken at endoscope, needle core or surgical incision or excision) obtained from the primary or metastatic tumour.

The archival FFPE tissue blocks must be obtained during initial diagnosis (before patient was exposed to any chemotherapy and/or radiation therapy).

Exclusion Criteria

1. Patient with CRC that has received any therapy for CRC before:

   1. surgical resection of tissue that would be utilised in this study

      or
   2. biopsy procedure for tissue that would be utilised in this study,
2. Patient who has received any investigational product within 28 days of the first day of palliative chemotherapy administration,
3. Patient with any significant history of non-compliance to medical treatments or with inability to grant reliable informed consent,
4. Patient with clinical or laboratory contraindication to receive SOC chemotherapy with fluoropyrimidines and oxaliplatin.
Efficacy of Gevokizumab in the Treatment of Patients With Behçet's Disease Uveitis (EYEGUARD™-B)

The objective of this study is to demonstrate the superiority of gevokizumab as compared to placebo on top of current standard of care in reducing the risk of Behçet's disease uveitis exacerbations

A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitis

Eligibility Criteria:
Inclusion Criteria:

* Behçet's disease diagnosis fulfilling the International Study Group Classification Criteria.
* History of Behçet's disease uveitis with ocular involvement of the posterior segment.
* Patients with a stable background treatment of oral corticosteroid and at least one immunosuppressive drug.
* Male or female, age ≥18 (or legal age of majority in the country) at selection
* For subjects with reproductive potential, a willingness to use highly effective contraceptive measures

Exclusion Criteria:

* Infectious uveitis, uveitis due to causes other than Behçet's disease.
* Monocular vision
* Presence of severe cataract or severe posterior capsular opacification.
* Contraindication to mydriasis or presence of posterior synechiae.
* Active TB disease.
* History of severe allergic or anaphylactic reactions to monoclonal antibodies
* History of malignancy within 5 years prior to Selection.

Other protocol-defined inclusion/exclusion criteria may apply
Surveillance of Fungal Infections During Construction Activity

Fungal infections in immunocompromised patients occuring during construction activities in hospitals have repeatedly been reported.

However, the question of a causal relation between construction activities and infections has never been addressed systematically and prospectively.

To answer this question, we will monitor our immunosuppressed patients' health status, as well as fine dust and aspergillus spore contents in the air during a three year construction activity period in our hospital.


Eligibility Criteria:
Inclusion Criteria:

* Kidney transplantation
* Chronic hemodialysis treatment
Multi-dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DDO-3055 Tablets in Patients With Anemia of Non-dialysis Chronic Kidney Diseases.

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multi-dose DDO-3055 tablets in patients with anemia of non-dialysis chronic kidney diseases.


Eligibility Criteria:
Inclusion Criteria:

* Patients with CKD anemia aged 18-70 years who were not on dialysis and were not expected to undergo dialysis during the study period, regardless of gender;
* Male weight≥50kg, female weight≥45kg, and 19kg/m2≤BMI\<28kg/m2;
* Signed informed consent.

Exclusion Criteria:

* Allergic constitution, suspected to be allergic to the study drug or any component in the study drug;
* Patients with acute coronary syndrome, stroke, thromboembolism (such as deep vein thrombosis or pulmonary embolism) or a history of seizures within 6 months before screening;
* Patients with uncontroll ed hypertension;
* New York Heart Association grade III or IV congestive heart failure at the time of screening;
* ALT,AST or total bilirubin exceeds 1.5 times the upper limit of normal value (ULN) during the screening period;
* Suffer from anemia other than CKD.
* Patients with a history of chronic liver disease;
* Patients with active bleeding or known coagulopathy;
* Patients who have any previous organ transplant or plan to perform organ transplant;
* Intravenous iron supplementation within 1 month before screening;
* Used erythropoiesis stimulator (ESAs), hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI), androgen, blood transfusion therapy within 3 months before screening;
* Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, and human immunodeficiency virus (HIV) antibody were positive;
* Patients with blood loss ≥400mL within 3 months before screening;
* Subjects who have taken other clinical trial drugs or are expected to have a legacy effect of the trial treatment;
* Participants who are unwilling to take contraception or male subjects who cannot guarantee not to donate sperm during the trial and within 30 days after the last dose; female subjects with fertility who did not use contraception for at least 14 days before dosing;or male and female subjects who did not agree to use physical contraception during the trial;
* Patients who had a positive blood pregnancy test and were breastfeeding at the time of screening;
* According to the study physician's judgment, there may be any other anemia factors that may exist, any possibility to increase the risk of the study, affect the subject's compliance with the protocol, or affect the physical or psychological disease or condition of the subject to complete the study.
The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women

This is an observational study to investigate the prevalence of osteoporotic fractures in post menopausal patients. Post menopausal patients who visit OS(orthopedic surgery) including GHs(general hospitals) and clinics will be enrolled.

This is an observational study to investigate the prevalence of osteoporotic fractures in post menopausal patients. Post menopausal patients who visit OS(orthopedic surgery) including GHs(general hospitals) and clinics will be enrolled. They will take the evaluation of spine X-ray and answer to a few questions. Their medical record will be reviewed and relevant clinical findings will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who were diagnosed post menopausal state
* Subjects over 50 years old
* The Definition of Post Menopause Women : Women whose last menstruation was over 12months ago
* Subjects who visit orthopedic surgery
* Subjects who have informed consents

Exclusion Criteria:

* Subjects who are not confirmed as post menopause state
* Subjects who do not understand the contents of questionnaire
* Subjects over 80 years old
* Subjects experienced any high energy fracture (including trash and fall) within 3 months.
* Subjects experienced a fracture except vertebral fracture within 6 months
* Unable to evaluate L-spine BMD over 2 levels because of spinal fracture or instrumentation for L-spine 1-4.
* Unable to evaluate BMD at both femur because of hip fracture or instrumentation.
A Randomized, Double-blind, Active Control, Parallel Group, Titration, Multicenter Study to Evaluate the Efficacy and Safety of Fimasartan

The purpose of this study is to evaluate the Efficacy and Safety of Fimasartan in patients with hypertensive diabetic chronic kidney disease.

The randomized subjects will take the investigational product (Fimasartan or Losartan) corresponding to each treatment group for 24 weeks. After that, all subjects will take Fimasartan for additional 120 weeks in an open-label, 2-parallel group study conducted with 2 groups in accordance with the blood pressure control criteria.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female adults aged 19 years or older
2. Blood pressure: Mean blood pressure is as below at screening.

   * For treatment-naïve patients: 140 mmHg ≤ SBP \< 180 mmHg and DBP \< 110 mmHg
   * For patients who are taking ACEI or ARB: 130 mmHg ≤ SBP \< 180 mmHg and DBP \< 110 mmHg
3. eGFR: ≥ 30 ml/min/1.73 m2 within the past 6 months
4. Albuminuria (ACR) excretion volume: Meets one or more of the following conditions

   * ACR \> 300 mg/g (or mg/day) within the past 12 months
   * There are at least two results of 30 ≤ ACR ≤ 300 mg/g (or mg/day) within the past 12 months and the interval between the two test is at least 12 weeks.
5. Patients with diabetes
6. Voluntarily provided a written consent to participate
7. Able to understand this study, be cooperative in the execution of the study

Exclusion Criteria:

1. Severe hypertension with mean SBP ≥ 180 mmHg or DBP ≥ 110 mmHg
2. Orthostatic hypotension with symptoms
3. Insulin dependent diabetes mellitus or uncontrolled diabetes mellitus
4. Patients on dialysis, patients with clinically significant cardiac and hepatic diseases
Digital Mindfulness-Based Treatment for Substance Use Disorder Recovery

The goal of this clinical trial is to evaluate the feasibility and acceptability of a digital mindfulness-based treatment for individuals in early recovery from substance use disorders. Participants are randomized to treatment-as-usual (TAU) or TAU plus the digital mindfulness-based treatment. The digital treatment will be completed over an 8-week period.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Fluent in English and have a 6th grade or higher reading level
* Have completed 1 month or more of SUD treatment
* Report use of their primary substance of choice in past 6 months
* Are not currently enrolled in residential/inpatient treatment
* Are willing to be randomized
* Are willing and able to participate for the entire study period
* Are willing to provide locator information for follow-up
* Own a working, WIFI-enabled smartphone

Exclusion Criteria:

* Current psychotic disorder
* High suicide risk characterized by suicidal ideation with intent
* Homicidal ideation posing imminent danger to others
* Pending legal case, imminent incarceration, or a planned move that results in inability to commit to procedures during the entire study period
* Participation in the Phase 1 User Testing study
A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis (0217-189)

The purpose of this study is to compare how well alendronate and raloxifene increase the bone density in women who have osteoporosis and have experienced menopause.


Eligibility Criteria:
Inclusion Criteria:

* Patient is postmenopausal (or surgically menopausal) for at least 6 months
* Patient must be diagnosed with osteoporosis
* Patient has spinal anatomy suitable for DEXA of the lumbar spine

Exclusion Criteria:

* Patient is receiving or has received treatment prior to randomization which might influence bone turnover
* Patient has a history of or evidence for metabolic bone disease (other than postmenopausal bone loss)
* Patient is receiving or is expected to receive during the course of the study any medication (other than study medication) which might alter bone or calcium metabolism
Comparison Between Different Ways for Using Lidocaine During FB

compare the efficacy and safety of nebulized lidocaine, oropharyngeal lidocaine spray, or their combination for better outcome of topical anesthesia in subjects undergoing diagnostic FB; severity of cough , pain during procedure , cumulative dose of anesthesia needed and its adverse reaction , overall satisfaction .

Flexible bronchoscopy (FB) is a commonly performed procedure in the diagnosis and treatment of several respiratory disease. Although FB is generally a short procedure, it is uncomfortable for the patient. At least the use of topical anesthesia during FB is essential, especially when performed without sedation. Effective topical anesthesia blunts airway reflexes such as gag, cough, and laryngospasm.

The reduction in cough not only improves patient comfort but also makes the procedure easier for the operator.

Among agents used for topical anesthesia, lidocaine is the most widely used drug because of its safety and favorable pharmacokinetic profile.

Lidocaine is available in various formulations (gel or solution) and can be delivered to the respiratory passages by using different modes (spray, nebulization, transtracheal injection, bronchoscope instillation, and others).

In this study, will compare the efficacy and safety of nebulized lidocaine, oropharyngeal lidocaine spray, or their combination for topical anesthesia in subjects undergoing diagnostic FB, for better outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patients above 18 years old will undergo FB are included in this study.

Exclusion Criteria:

* known hypersensitivity to lidocaine.
* Pregnancy.
* hemodynamic instability.
* failure to provide informed consent.
Differentiation of Pseudoprogression and True Progression Through High Field Susceptibility Weighted Imaging and R2*

Using a multi-echo gradient echo sequence to calculate R2\* and quantitative susceptibility maps and well as susceptibility-weighted imaging post processing the investigators hypothesize that the investigators would be able to distinguish between pseudoprogression and true progression with the use of an easily implementable sequence on clinical MRI scanners.

Post-treatment radiographic imaging change (PTRIC) is seen in approximately 50% of patients who are treated for brain neoplasms using chemotherapy and radiotherapy. PTRIC can be attributed to true disease progression or a form of benign radiographic enhancement, known in literature as pseudoprogression. Of these patients, 50% of them have benign radiographic enhancement that is usually spontaneously resolved and required no intervention. The other 50% require immediate medical intervention, or more aggressive treatment for true progression. Currently standard medical practise is to administer a prophylactic treatment of chemotherapy to all patients with PTRIC with a follow up scan 3-6 months after initial PTRIC diagnosis, leading to up to 50% of patients receiving an unneeded dose of chemotherapy. The investigators hope to take advantage of the differentiation in tissue types and vascularization between true progression tumour and pseudoprogression to be able to identify patients who would not need to be administered a prophylactic dose of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. The subject must consent to participate.
2. The subject must be above the age of 18.
3. Patients must be classified as possible pseudoprogression or true progression
4. Patients scoring \>= 70 on the karnofsky performance status.

Exclusion Criteria:

1. Any subject with contraindication to an MRI procedure as listed in the Magnetic Resonance Environment Screening Questionnaire.
2. Any subject who may be unable to tolerate the MRI environment due to physical size and/or known tendency to claustrophobia.
3. Any subject who does not expect to be available to attend the for the required study MRI scans
4. Patients scoring \< 70 on the karnofsky performance status.
5. Attending radiation oncologist or neurologist determines patient is no longer able to consent for themselves.
Laparoscopic Sleeve Gastrectomy Short Term Follow up

Laparoscopic Sleeve Gastrectomy (LSG), Also known as longitudinal or vertical gastrectomy.

LSG was initially considered a first-stage operation in high-risk patients before bilio-pancreatic diversion or Roux-en-Y gastric bypass surgery. However, LSG was subsequently found to be effective as a single procedure for treatment of morbid obesity.LSG functions mainly as a restrictive procedure in which about 75 % of the stomach is removed leaving a narrow gastric tube or sleeve. So, it limits the amount of food that can be eaten at one time via inducing early satiety after eating a small amount of food due to early distension of the fashioned gastric sleeve giving a sense of satiety, consequently losing excess body weight by time.Sleeve gastrectomy may also cause a decrease in appetite by reducing the amount of Ghrelin (hunger hormone) produced by the stomach.

All patients,males and females with age (20-50 years old) with morbid obesity (BMI ≥ 40 kg/m2 or \> 35 kg/m2 associated with co-morbidity) randomly admitted to Assiut University Hospital-General Surgery Department.

Pre-operative: Assessment of; BMI (Body Mass Index), Fasting Blood Glucose level (FBG), Associated Co-morbidities (as hypertensions \& sleep apnea).

Operative (During Operation):

All patients undergo LSG by single team work with intra-operative oesophageal bougie 36 french with use of laparoscopic gastro-intestinal anastomosis(GIA) stapler.

Post-operative:

Patients are discharged from the hospital after they can start oral diet.

Post-operative evaluation of:

1. Complications:

   1. Early complications: during the first 2 weeks after surgery,which include hemorrhage (intra-luminal or extra-luminal), staple line leak, vomiting and infection (surgical site infection or intra- abdominal abscess formation)
   2. Late complications: from 2 weeks to 6 months post-operative, which include stricture of the gastric sleeve, gastro-esophageal reflux disease (GERD) and nutritional deficiencies.
2. Excess weight loss (EWL) by using BMI Follow up of patients at fifteen days, one month, two months, three months and six months after surgery.
3. Assessment of Blood Glucose level during visits.
4. Measurement of blood pressure during visits (if there is associated hypertension).

Eligibility Criteria:
Inclusion Criteria:

* All patients,males and females with age (20-50 years old) with morbid obesity (BMI ≥ 40 kg/m2 or \> 35 kg/m2 associated with co-morbidity), and are fit for laparoscopic surgery.

Exclusion Criteria:

* Patients having severe co-morbidity who are not fit for surgery or general anaesthesia.
* Patients with age below 20 years or above 50 years.
Can Cognitive Therapy Rating Scale (CTRS) be Used Across Cultures? Enhancing Cultural Relevance of CTRS

Translate and adapt the Cognitive Therapy Rating Scale (CTRS) into Urdu language and establishing the psychometric properties (reliability, validity, and norms) of the translated scale

The purpose of this study is to increase the accessibility and accuracy of clinical assessments, ultimately improving the quality of mental health care delivery and advancing research in the field of clinical psychology within Urdu-speaking communities

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 to 65 years At least 5 years of education Score of 8 or higher on Hospital Anxiety and Depression Scale-Depression or Anxiety scales as measured by their primary care clinician

Exclusion Criteria:

* Substance use disorder according to DSM-5 TR criteria Significant cognitive impairment (for example, profound learning disability or dementia) Active psychosis as determined by their primary care clinician