cyrilzakka/clinical-trials huggingface dataset:
Prostate Cancer Monitoring Using [18F]DCFPyL and Blood Based Biomarkers

Primary Objective:

* To determine whether changes in uptake of \[18F\]DCFPyL PET/CT scans at baseline and after 6 weeks of treatment for metastatic castrate resistant prostate cancer, correlates with radiographic progression free survival (rPFS) as defined by Prostate Cancer Working Group 3 (PCWG3) criteria.

Secondary Objectives:

* To determine whether changes in uptake of \[18F\]DCFPyL PET/CT scans correlate with overall survival (OS)
* To determine whether baseline SUVmax correlate with rPFS
* To compare number of lesions detected with standard imaging at baseline and at the time of progression

Prostate cancer is the most common cancer and the third most common cause of cancer deaths in American men. The lethal form of the disease is metastatic castrate resistant prostate cancer (mCRPC). Serum prostate specific antigen (PSA) testing has been relied upon heavily as a marker of disease and is commonly used in the community to guide therapy.

PyL, also known as \[18F\]DCFPyL, is a second-generation fluorinated prostate-specific membrane antigen (PSMA) targeted positron emission tomography (PET) imaging agent. In preliminary studies it demonstrates a higher detection of metastatic prostate lesions compared to standard imaging. However, the role of \[18F\] PyL in tumor response to therapy has not been evaluated, specifically the potential to serve as a predictive biomarker of response. Given the high cost of current therapeutic agents in mCRPC, there is a need for an early response biomarker to stratify which patients will benefit from therapy and which will not. This will also allow for earlier change in management of patients who will not response to these therapies, potentially improving patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of prostate cancer
* Age ≥ 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
* Metastatic castrate resistant prostate cancer as defined by Prostate Cancer Working Group 3
* Eligible to receive systemic treatment (abiraterone, enzalutamide, docetaxel, cabazitaxel) for their disease
* Ability to understand and willingness to sign a written informed consent document
* Wiling to comply with clinical trial instructions and requirements

Exclusion Criteria:

* History of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin
* Presence of prostate brachytherapy implants
* Administration of another radioisotope within five physical half-lives of trial enrollment
* Radiation or chemotherapy within 2 weeks prior to trial enrollment
* Serum creatinine \> 3 times the upper limit of normal
* Serum total bilirubin \> 3 times the upper limit of normal
* Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) \>5 times the upper limit of normal
* Inadequate venous access
Light Therapy for Bipolar Disorder. Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial

The purpose of this study is to understand the efficacy of light therapy for bipolar depression.

Bipolar Disorders (BD) are associated with chronic depression, disability, and increased suicide risk. Building on earlier findings, we conducted a 6-week randomized, double-blind, placebo-controlled trial to investigate the efficacy of midday light therapy for bipolar depression. The aims were to examine the change in depression levels and the proportion of patients who responded and remitted. We assessed predictors of response with measures of side effects, sleep quality, suicidality, and psychosocial functioning. We included depressed adults with BD-Type I or II confirmed on the SCID interview and taking stable-dosed antimanic medication. We excluded patients with psychosis, rapid cycling, obsessive compulsive disorder, alcohol or substance use disorders, hypomania or mania, and severe suicidality. Patients were randomized to 7000 lux broad spectrum light therapy OR 50 lux dim red light for 45-60 minutes daily. Weekly, the blinded-clinician assessed symptoms with the Structured Interview Guide for the Hamilton Depression Scale with Atypical Depression Supplement (SIGH-ADS) and global functioning.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-65 years
* DSM-IV Criteria BD I or II depressive episode,
* SIGH-ADS \>20; duration \>2 weeks.
* Stable dose antidepressant drug \>8 weeks with concurrent antimanic drug
* Controlled thyroid disease
* Subjects with preexisting eye diseases will be included.
* Able to provide informed consent
* Stable minimum dose antimanic drug \>4weeks: lithium 0.5 mEq/L, divalproex Na 50 mcg/mL, olanzapine 5mg daily, carbamazepine 4mg/L; lamotrigine 100mg daily, risperidone 2mg daily, quetiapine 400 mg daily, ziprasidone 10 mg bid, and aripiprazole 5 mg qd.
* Stable unchanged psychotherapy for \>16weeks

Exclusion Criteria:

* The following eye diseases: retinal disease, cataract surgery and lens removal, macular degeneration,
* Taking photosensitizing drugs such as phenothiazines (chlorpromazine), antimalarial drugs, melatonin and hypericum.
* Acute psychosis (DSM-IV Criteria)
* Rapid cycling in the past 1 year
* Obsessive compulsive disorder
* Alcohol or substance abuse or dependence in the past 6 months.
* MRS\>5
* Recent history of a suicide attempt (3 months) or active suicidal Ideation (SIGHADS item H11 \>2)
* Beta-adrenergic blockers, exogenous melatonin, chronic NSAIDS
A Study to Evaluate the PK, Safety and Tolerability of HCP1803.

A randomized, open-label, single-dose parallel study to evaluate the pharmacokinetics, safety and tolerability of HCP1803 in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Age 19\~45 years in healthy male volunteers
2. Weight ≥ 55kg and BMI 18 \~ 30 kg/m\^2
3. Subjects who agree to use clinically accepted dual contraceptives up to 14 days after the last administration date of the investigational product and not to provide sperm.
4. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing.

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
2. Subjects who judged ineligible by the investigator
Variability in Nocturnal Oxygen Parameters in Suspected Obstructive Sleep Apnea (OSA)

The investigators would like to evaluate the variability of oxygen (and PPG) parameters during 7 nights at home. Oxygen (and PPG) parameters will also be evaluated during 1 night at the hospital (diagnostic polysomnography).

Based on currently developed algorithms, surrogate apnea-hypopnea index (AHI), cardiovascular status and the variability of these parameters will be evaluated.

The main objective of this trial is to evaluate the variability in nocturnal oxygen (and PPG) parameters during 7 consecutive nights at home and to identify clinical predictors of variability in patients with suspected OSA.

Data regarding sleep position, alcohol intake and sleep duration will be evaluated (these parameters could be important to explain variability).

Additional objectives are to compare the parameters measured at home with the parameters measured during an in-hospital polysomnography.

The investigators will also evaluate variability in the surrogate AHI described by the group based on the measurements at home and the impact of multi-night evaluation of oxygen (and PPG) parameters on the recently developed mICS algorithm will be explored.

This study is a first explorative approach for further (multi-site) work to define the burden of OSA associated with cardiovascular or psychofunctional problems.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected OSA with a clinical indication to perform a polysomnography

Exclusion Criteria:

* Patients younger than 18 yrs
* Patients not able to read or understand the informed consent content on the purpose of the study, due to visual, intellectual or language issues
* Patients with neuromuscular disease or chest wall disease with suspected hypoventilation
Efficacy Study for the Symptomatic Treatment of Seasonal Allergic Rhinitis

The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg, compared to Cetirizine and placebo for the treatment of seasonal allergic rhinitis.

In this pivotal, multicentre, international, randomized, double-blind, placebo and active-comparator controlled, parallel study, 683 patients with SAR will be enrolled. Patients will be required to be 12-70 years old, have SAR for ≥2 years, a positive skin test, total nasal and non-nasal score (TSS) ≥36 (out of 72) during run-in, and a composite instantaneous nasal symptom score ≥6 (out of 12) the morning before randomization. The primary efficacy endpoint will be the AUC of reflective TSS from baseline to Day 14.

Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex between 12 and 70 years of age.
* Patients with documented clinical history of SAR, for at least 2 years prior to the study inclusion.
* Positive skin prick test for at least one of the seasonal allergen specific of the geographical area.
* A previous positive Prick test, or a positive IgE Test (RAST) may also be accepted for inclusion, if performed within 12 months prior to the inclusion.

Exclusion Criteria:

* Patients who have non-allergic rhinitis (vasomotor, infectious, drug-induced, etc.).
* Negative skin prick test (as defined in point 6.1.1.).
* Patients with nasal polyps or a significant deviation of the nasal septum as judged by the investigator as well as nasal intervention in the previous 6 months. Any other nasal illness that can interfere with the aim of the study.
* Patients who have acute or chronic sinusitis as judged by the investigator.
* Patients who have received anti-allergy immunotherapy in the previous two years or are still receiving this kind of therapy.
* Patients who are taking or have taken specified medications prior to randomisation in the study and have not complied with the specified washout period
Urdu Version of Lower Extremity Functional Scale: Reliability and Validity Study

The objective of the research is to translate and to culturally familiarize the Lower extremity functional scale into the Urdu language along the investigation if the Lower Extremity Functional Scale is reliable and validate in the Pakistani population with Lower extremity musculoskeletal disorders and to check the correlation with Short Form - 36.

The questionnaire will be translated into Urdu and cross-culturally modified. Internal consistency, test-retest reliability, conceptual validity, discriminative validity, responsiveness, and concurrent validity will be examined in 150 participants seeking treatment for lower extremity dysfunction using the Urdu version of the Lower Extremity Functional Scale.

Eligibility Criteria:
Inclusion Criteria:

* From16 years Old to 60 Years Old
* Presence of an Lower extremity musculoskeletal disorders like soft tissue injuries, joints and muscles injuries
* No intervention between the test-retest assessments

Exclusion Criteria:

* To complete the forms because of a psychological Impairment.
* Illiteracy or lack of understanding of Urdu Language
* The presence of any kind of bone fracture
Changes in Breast 3D Ultrasound Measurements Using Toremifene

To investigate if there are detectable changes in volume and circulation in breasts of healthy volunteers using toremifene 20 mg in luteal phase of the menstruation cycle versus nonmedicated cycle.

20 women were participated to this trial.

Eligibility Criteria:
Inclusion Criteria:

* age 25-45 healthy person
* regular menstrual cycles
* safe contraception(for example sterilization or condom)

Exclusion Criteria:

* gynecological or other type of cancer
* hormonal contraception
* pregnancy
To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fasting Conditions

To demonstrate the relative bioavailability of Divalproex Sodium 500 mg delayed release tablets under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Serum Concentrations, Physical and Psychological Well-being in Metabolic Syndrome

The purpose of this study was to investigate the serum concentrations, physical and psychological well-being characteristics in patients having chronic musculoskeletal pain with metabolic syndrome, and to compare patients without metabolic syndrome.

Metabolic syndrome (MetS) is a combination of metabolic risk factors such as impaired glucose level, dyslipidemia, hypertension, and central obesity. MetS has become a large public health issue with common interrelation to different accompanying disorders. Moreover, the link between MetS and musculoskeletal disorders has previously been demonstrated.

Presence and prevalence of MetS in patients having musculoskeletal pain seems common and interrelated.However, to our knowledge, manifestations with clinical symptoms of MetS, some inflammatory markers via serum concentrations and physical and psychological health profiles of patients with seeking treatment from outpatient physical therapy for musculoskeletal pain conditions have not been researched up to now.

Eligibility Criteria:
Inclusion Criteria:

To be a volunteer patient with a chronic non-specific musculoskeletal pain disorder, including knee osteoarthritis, rotator cuff tear, adhesive capsulitis, and non-specific low back, back or neck pain for more than 6 months.

Exclusion Criteria:

the presence of severe physical disability, psychiatric disorder, malignant tumors, pregnancy, chronic alcohol consumption, gout, heart failure, liver and renal dysfunction.
Study of Anemia in Chronic Kidney Disease (CKD) Among High-Risk Hypertensive and Diabetic Patients in Pakistan

The purpose of this study is to evaluate the prevalence of CKD-related anemia at an early stage through screening of high-risk patients in Pakistan at the level of physicians, cardiologists, and diabetologists. The information gathered may serve as a foundation in formulating national guidelines for better early diagnosis and management of patients with CKD.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 40 years
* Known hypertension and/or diabetes for at least 3 years
* Positive dipstick test result for proteinuria

Exclusion Criteria:

* Known CKD
* Receiving erythropoietin
* Blood transfusion within 8 weeks
* History of acute or chronic bleeding, hemolysis, or hemoglobinopathy
A Study of Individualized Radiotherapy Based on a Prediction Model of Lymph Node Metastasis in Hepatocellular Carcinoma

Objectives:

1. To further validate the predictive efficacy of our established microRNA prediction model of HCC lymph node metastasis.
2. To establish a precise therapeutic mode of prophylactic radiation therapy in high-risk patients with HCC with lymph node metastasis under the guidance of a microRNA prediction model.

First, screening out patients who underwent hepatic tumor resection and pathologically diagnosed as HCC .

Then，performing the detection of miR-145, miR-31 and miR-92a by using the HCC lymph node metastasis microRNA correlation prediction model established in our previous study. The patients are judged as high risk of lymph node metastasis and low risk Patients, then high-risk patients under the condition of informed consent into the group, randomized into treatment group and control groups.

Last, Patients enrolled in the treatment group were treated with radiotherapy and followed up.

Eligibility Criteria:
Inclusion Criteria:

1. patients underwent liver tumor resection and pathological diagnosis of HCC in our hospital.
2. The tumor samples of these HCC patients were detected by in situ hybridization with miR-145, miR-31 and miR-92a. We used the previously established HCC lymph node metastasis microRNA prediction model to determine the patients with high-risk lymph node metastasis and low-risk patients at high risk Patients were randomly assigned into treatment group and control group with informed consent.
3. HCC patients were not receive other anti-cancer treatment.
4. Blood routine examination was normal.
5. Child-Pugh grade A, normal liver and kidney function in the normal range (including ALT or ASL within 2.5 times the normal), WBC\> 3 × 109 / L, Hb\> 90g / L, PLT\> 50 × 109 /
6. HCC patients were not receive the history of upper abdominal radiotherapy.
7. sign the informed consent.
8. age 18-75 years old.
9. KPS score 80-100 points.

Exclusion Criteria:

1. accepted other anti-cancer treatment.
2. Patients was determined to be low-risk lymph node metastasis by the pre-established HCC lymph node metastasis microRNA prediction model.
3. blood and liver and kidney dysfunction.
4. can not control the infection.
5. at the same time the merger of other malignant tumors.
6. while using other experimental drugs or to participate in other clinical trials.
7. serious heart, lung, kidney disease.
8. pregnant or lactating women.
9. serious nervous system disease, can not clearly tell the treatment
Efficacy, Safety and Tolerability of Cadazolid in Subjects With Clostridium Difficile Associated Diarrhea (CDAD)

Cadazolid is a new antibiotic developed for the treatment of Clostridiun difficile associated diarrhea (CDAD), also known as Clostridium Difficile Infection (CDI). The purpose of the study was to evaluate the efficacy and safety of different doses of cadazolid in order to find the dose of cadazolid to be used for further clinical development of the compound in subjects with CDAD.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female
* At least 18 years of age
* With a diagnosis of Clostridium Difficile-associated diarrhea (CDAD): first occurrence or first recurrence.

Key Exclusion Criteria:

* Concurrent life threatening condition.
* Immuno-compromised subjects, concomittant immuno-suppresive treatment.
* Concomitant antimicrobial treatment for CDAD.
* Any circumstances or conditions, which, in the opinion of the investigator, would affect full participation of the subject in the study or compliance with the protocol
Impact of Therapeutic Patient Education on the Toxicity of Immune Checkpoint Inhibitors in Oncology

The aim of this therapeutic education program is to reduce the apparition of immune-related Adverse Event with patients treated with ICI

This study aims to highlight the impact of Patient Therapeutic Education (TPE) in oncology. TPE is an integral part of the care pathway for patients with a chronic pathology such as diabetes, asthma, chronic obstructive pulmonary disease, cardiovascular diseases requiring anticoagulants, haemophilia, renal failure, HIV infection, autoimmune diseases etc.... front of therapeutic progress, many cancers are now taken for a chronic disease.

In oncology, TPE starts to grow. Indeed, TPE makes the patient more autonomous, which could reduce the occurrence and / or aggravation of some toxicities, improve the quality of life, the effectiveness of treatment and optimize health costs. Therefore, it is important to develop programme of therapeutic education in oncology.

The toxicity of ICI is unusual and sometimes lethal. This toxicity must be recognized and managed quickly to maintain a satisfactory dose-intensity. TPE finds its place by raising awareness among patient to the occurrence of these toxicities.

This randomized TPE versus standard care study project will assess the contribution of education in the management of severe toxicities. The investigators believe that changes in patient behaviour will reduce the number of toxicities ≥3 in the TPE arm.

Eligibility Criteria:
Inclusion Criteria:

* Patient with Melanoma, Non-Small Cell Bronchial Cancer, renal cell carcinoma, Ca carcinomas of the upper airways to be treated with ICI
* Patient who has never received treatment by ICI
* Informed patient who signed his consent
* Age \> or = 18 years
* Social insurance

Exclusion Criteria:

* Patient receiving corticosteroid or immunosuppressant 14 days before inclusion
* Immunocompromised patient
* Uncontrolled brain metastases
* Refusal to participate, patient protected by guardianship
* Patient unable to understand the study or unable to follow the education sessions
Relationship Between Morbimortality and Basal Activated Clotting Time (ACT) in Patients Undergoing Vascular Surgery

Check whether patients with higher comorbidity and risk of complication, estimated using the V (p) -POSSUM score, ACS NSQIP and the ASA classification, present higher baseline activated clotting time values.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing vascular surgery requiring intraoperative heparinization

Exclusion Criteria:

* Pregnant women
* SARS-CoV-2 PCR positive (performed 24-72h prior to surgery)
* Severe plaquetopenia \<50,000
ISP-001: Sleeping Beauty Transposon-Engineered B Cells for MPS I

A first-in-human study using ISP-001 in adult patients with Mucopolysaccharidosis Type I Hurler-Scheie and Scheie.

This is a Phase 1, first-in-human, open-label, single-arm study in which adult patients with Mucopolysaccharidosis Type I Hurler-Scheie and Scheie are treated with autologous plasmablasts engineered to express α-L-iduronidase (IDUA) using the Sleeping Beauty transposon system (ISP-001). This study will evaluate the safety and tolerability of ISP-001.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Mucopolysaccharidosis type I Hurler-Scheie or Scheie syndrome.
* Age ≥ 18 years at time of study registration.
* Creatinine clearance, calculated or measured directly, that is \>60ml/min/1.73m2.
* Ejection fraction ≥ 40% by echocardiogram.
* Must commit to traveling to the study site for the necessary follow-up evaluations.
* Must agree to stay \<45-minute drive from the study site for a minimum of 5 days after cell infusion.

Exclusion Criteria:

* Known familial inherited cancer syndrome. Suspected cases will be investigated, per the physicians discretion, using relevant genetic tests to determine presence of germline mutations.
* History of B cell related cancer, EBV lymphoproliferative disease or autoimmune disorders.
* Evidence of active graft-vs-host disease.
* Underwent a previous hematopoietic stem cell transplant (HSCT).
* Requirement for systemic immune suppression.
* Requirement for continuous supplemental oxygen.
* Any medical condition likely to interfere with assessment of safety or efficacy of the study treatment.
* In the investigator's judgement, the subject is unlikely to complete all protocol-required study visits or procedures, including follow up visits, or comply with the study requirements for participation.

Other protocol defined inclusion/exclusion criteria may apply.