cyrilzakka/clinical-trials huggingface dataset:
A Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors and Subsequent Dose Expansion Cohorts

This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be conducted in two parts: the Dose Escalation Phase and the Dose Expansion Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose(s) (RP2D) of PT-112 Injection and evaluate its safety and tolerability, and PK (pharmacokinetics).

The Dose Escalation Phase is complete and no longer enrolling.

The Dose Expansion Phase has two cohorts: one cohort for the study of PT-112 in patients with thymoma and thymic carcinoma (Cohort A), and one cohort for the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC) (Cohort D).

This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be conducted in two parts: the Dose Escalation Phase, and the Dose Expansion Phase

The Dose Escalation Phase and the Dose Expansion Thymoma Cohort are complete and no longer enrolling.

The Dose Expansion Phase of the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC) is open and enrolling.

Eligibility Criteria:
Key Inclusion Criteria:

* Male \>/= 18 years of age
* Histologically or cytologically confirmed adenocarcinoma of the prostate.
* Document current evidence of metastatic castration-resistant prostate cancer (mCRPC), where metastatic status is defined as having documented metastatic lesion(s) on either bone scan or CT/MRI scan.
* Patients who have received at least three prior intended life-prolonging therapies for metastatic disease.
* Eastern Collaborative Oncology Group (ECOG) Performance Status of 0-1.
* Progressive disease, either measurable on physical examination or imaging by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or PCWG3 or by informative tumor marker(s).
* Adequate organ function based on laboratory values.
* If there is a known history of brain metastases, either treated or untreated, the disease must be stable.

Key Exclusion Criteria:

* Any cytotoxic chemotherapy within 21 days prior to initiation of study drug.
* Any immunomodulatory drug therapy, anti-neoplastic hormonal therapy, immunosuppressive therapy, corticosteroids, or growth factor treatment within 14 days prior to initiation of study drug.
* Bone marrow reserve which is not adequate for participation in this trial.
* Radiotherapy within 14 days prior to baseline.
* Fraction of radiotherapy to \>25 % of active bone marrow.
* Major surgery within 28 days prior to initiation of study drug.
Effect of Rotating Magnetic Therapy on Blood Glucose Spectrum of Type 2 Diabetic Patients With Glargine Therapy

The aim of the study is to assess the eﬀect of Rotating Magnetic Therapy on blood glucose spectrum of type 2 diabetic patients with glargine therapy using flash glucose monitors


Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate and sign informed consent prior to the study
* Patients with type 2 diabetes, who met WHO1999 diagnostic criteria, aged 18-70 years old, and were treated with insulin glargine alone and/or insulin glargine combined with oral hypoglycemic drugs, the treatment regimen was stable for more than 2 months
* Fasting blood glucose ranged from 6.1 to 13.9mmolL, and postprandial (or random) blood glucose was \<22.2mmol/L.
* Subjects can and are willing to conduct flash glucose monitoring and regular diet and exercise

Exclusion Criteria:

* Patients with insulin allergy
* Patients treated with GLP-1a or DPP-4 inhibitors or multipoint subcutaneous insulin injection in the last three months
* Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value and serum creatinine 1.3 times higher than the upper limit of normal value
* Patients with metal foreign bodies or pacemakers
* Patients with a history of surgery in magnetic therapy site within one year
* Patients with obvious discomfort to magnetic therapy
* Patients with bleeding or bleeding tendency
* Patients with poor compliance and irregular diet and exercise
* Patients with acute complications of diabetes, such as infection, diabetic ketoacidosis, hypertonic coma and so on, and patients with stress status within four weeks
* Patients who are pregnant, breast-feeding, or intending to become pregnant
* Any other apparent conditions or associated diseases determined by the investigator: severe cardiopulmonary, endocrine, neurological, tumor, other pancreatic diseases, history of mental illness
Development of Therapeutic Intervention for Sleep in Alzheimer/Caregiver Dyads

This non-intervention qualitative study will use focus groups to assess the feasibility and acceptability of a proposed intervention for a future study. The focus group will discuss a potential biobehavioral family self-management intervention designed to improve sleep in persons with Alzheimer's disease (PAD) and their caregivers (CG).

Approximately 16 caregivers of home-based PAD/CG dyads (person with Alzheimer's disease/caregiver dyads) will be recruited from the community. A series of two audiotaped focus groups will be conducted with these caregiver participants. The first focus group will explore perspectives on what constitutes a feasible and acceptable intervention to improve their sleep and associated symptoms. The second focus group will consist of follow up and confirmation of findings from the first focus group. The intervention will be developed and refined based upon focus group findings.

Eligibility Criteria:
Inclusion Criteria:

1. screen positive on the PROMIS sleep disturbance and associated symptoms measures
2. be a caregiver within a PAD/CG dyad
3. speak/understand English
4. agree to be audiotaped during focus group participation
5. be at least 18 years of age

Exclusion:

1. they negative on the PROMIS sleep disturbance and associated symptoms measures,
2. are not a caregiver within a PAD/CG dyad,
3. do not speak/understand English,
4. refuse to take part in audiotaping of the focus groups,
5. are not at least 18 years of age.
Main Pancreatic Duct Diameter

The maximal diameter of the pancreatic duct will be measured by endoscopic ultrasound at four different parts:

* Pancreatic head
* Pancreatic neck
* Pancreatic body
* Pancreatic tail

All patients without pancreatic or biliary disorders undergoing upper-GI endoscopic ultrasound (EUS) are eligible for the study.

The maximal diameter of the pancreatic duct will be measured by endoscopic ultrasound in millimeters at four different parts:

* Pancreatic head
* Pancreatic neck
* Pancreatic body
* Pancreatic tail

Eligibility Criteria:
Inclusion criteria:

* Patients undergoing EUS for investigation of non-pancratic disease (e.g. subeptithelial tumor of the upper GI-tract
* Indication for EUS is undependent from the study
* Written informed consent
* Age ≥18 years

Exclusion Criteria:

* Pancreatic diseases (chronic or acute pancreatitis, pancreatic tumor, pancreatic cyst, etc.)
* Disorders of papilla duodeni major/minor (adenoma/carcinoma of papilla duodeni major or minor)
* Biliary disorders (bile duct stones, cholangio carcinoma, cholangitis)
* Elevated Bilirubin and/or Lipase
Lymph Node Yield in Colon Cancer Resection Specimens

In this study, we aimed to develop a predictive model of lymph node yield in a series of colon cancer resection specimens with detailed anatomic and surgical technique data.

Lymph node yield in colon resection specimens has been associated with the accuracy of staging and cancer outcomes. It has been proposed that the more central the mesenteric vascular ligation, the greater the nodal yield. However, the optimal number of harvested nodes is still a matter of debate. We prospectively evaluated the relation between specimen properties such as lenght, area, tumor location and pedicle length to the number of harvested nodes and rate of node positivity.

Eligibility Criteria:
Inclusion Criteria:

The surgical patients with a histologic diagnosis of colonic neoplasm, Colectomy of any type, including the right hemicolectomy, the left hemicolectomy, the sigmoid resection, segmental colon resection

Exclusion Criteria:

* rectal or rectosigmoid cancer colectomy beyond the inclusion criteria for colectomies patients younger than 18 previous colon resection emergency colon resection familial adenomatous polyposis or ulcerative colitis
LifePearl-Iri Pharmacokinetic Study

The primary purpose of the study is to evaluate the pharmacokinetic profile, safety, and efficacy of LifePearl microspheres loaded with irinotecan in the treatment of liver predominant mCRC by chemoembolization.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years old
* Histologically proven mCRC
* At least 1 measurable liver metastasis \> 1 cm (mRECIST) Liver predominant disease ( ≥ 80% of metastatic disease confined to the liver)
* No portal vein involvement
* Performance status 0 or 1
* Life Expectancy ≥ 3m
* Adequate Hematologic function (ANC≥1.5 10\^9/l; PLT≥75 10\^9/l; INR (international normalized ratio) ≤1.3)
* Adequate liver and renal function (Total bilirubin ≤2.0 mg/dl; ALBUMINE 2.5g/dl; Serum creatinine ≤2.0 mg/dl; ALT (alanine transaminase),AST (aspartate transaminase) ≤5 times ULN)
* Less than 50% liver tumor replacement
* Patient has provided written informed consent
* Patient is affiliated to social security or equivalent system (France only)

Exclusion Criteria:

* Eligible for curative treatment (resection/RFA) History of hepaticocholangiojejunostomy or obstructive biliary disease (with/without previous treatment)
* Previous liver embolization
* Contraindication for intra-arterial embolization and local irinotecan administration
* Allergy to contrast media
* Patient is co-treated with potent CYP3A4/UGT1A1 (cytochrome P450 3A4/uridine diphosphate glucuronosyltransferase 1A1) inducers, i.e. rifampin, rifabutin, phenytoin, phenobarbital, carbamazepine and St John's Wort
* Patient is currently participating in a clinical trial with an investigational drug or a device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
* In the Investigator's opinion patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
* Patient is under judicial protection (France only)
Myofascial Points Treatment With Focused Extracorporeal Shock Waves (ESW)

Plantar fasciitis (PF) is a common cause of heel pain. Among the several conservative treatment options, Extracorporeal Shock Wave Therapy (ESWT) is considered the standard treatment.

Recent studies suggest that PF may be sustained by a myofascial impairment proximal to the pain area with a biomechanical disequilibrium of the entire lower limb and pelvis. Therefore, by combining the concepts of Fascial Manipulation and ESWT, the purpose of this open label randomized controlled clinical trial is to evaluate the effectiveness of the ESWT on myofascial trigger points of lower limb in a sample of subjects with PF.

Patients with PF were randomly assigned to an Experimental treatment Group (EG), treated with focused ESWT on myofascial points, and a Control Group (CG), treated with the focused ESWT traditional approach on the medial calcaneal tubercle.

Outcome measures included the Foot and Ankle Outcome Score (FAOS) and the Italian Foot Functional Index (17-iFFI).

The assessment was made before the first session(baseline-T1), immediately before the second session (T2), immediately before the third session (T3), at 1month (T4) and 4 months' follow-up (T5).

Thirty patients who satisfied inclusion and exclusion criteria were enrolled.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age,
* the presence of heel pain ≥ 3 months duration unresponsive to first-choice conservative treatments (non-steroidal anti-inflammatory and/or other analgesic drugs, exercise program, insoles),
* specialist diagnosis of plantar fasciitis confirmed with clinical examination,
* pain intensity ≥ 5 at the Visual Analog Scale (VAS)

Exclusion Criteria:

* previous ankle/foot fracture or surgery,
* previous ankle/foot infections,
* neurological deficits of the lower limbs,
* diagnosis or suspect of fibromyalgia,
* local steroid injection within the previous 3 months,
* diabetes mellitus,
* vascular diseases
Responding to Elder Abuse in GERiAtric Care: Educational Intervention

The prevalence of elder abuse has been reported between 10-15% in international studies. Elder abuse may include both physical, emotional, sexual and financial abuse as well as neglect and it occurs at the hand of both professionals and family members, including adult children and intimate partners. Elder abuse has been associated with psychological ill-health, disability, increased hospitalization, emergency department use and admission to nursing facilities. Elder abuse is however often unknown to health care providers. Older adults are hesitant to disclose abuse and health care providers are often reluctant to ask questions.

In this study an interactive educational model for health care professionals about elder abuse will be tested. The model consist of theoretical lectures, brief films showing patient encounters, group discussions and forum play, a form of participatory theater. Both group discussions and forum play will be using case scenarios as a cornerstone.

The validated questionnaire REAGERA-P will be used for self-reported measures

Please refer to the uploaded study protocol for a detailed description of the study.

Eligibility Criteria:
Inclusion Criteria:

* Employee at one of the clinics participating in the trial
* Work tasks involves direct patient contact, at least part time
* Participation at the training sessions

Exclusion Criteria:

* Only administrative work and no direct patient contact
* Not participating at the training session
Pegylated Liposomal Doxorubicin Plus Albumin-Bound Paclitaxel and Trastuzumab in HER-2 Positive Breast Cancer

The purpose of this study is to evaluate the efficacy and safety of pegylated liposomal doxorubicin（PLD）plus Albumin-Bound Paclitaxel and trastuzumab as neoadjuvant therapy in HER-2 positive breast cancer.

This is a single-center, prospective, single arm phase II study. Eligible patients will receive neoadjuvant therapy with pegylated liposome doxorubicin (PLD)/albumin-bound paclitaxel/trastuzumab regimentation.

This study consists of two phases, the first phase aims to determine the maximum tolerated dose (MTD) of PLD, and the second phase will explore the efficacy and safety of the regimen.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and voluntarily receive the research procedures according to protocol,willingness to sign the written informed consent document;
2. Female patients aged from 18 to 70 years old;
3. Histologically confirmed as invasive breast cancer. occult breast cancer, inflammatory breast cancer and eczematoid carcinoma are ineligible;
4. Clinical stageⅡ-Ⅲ;
5. HER-2 Positive（defined by: IHC 3+ or ISH positive）;
6. Without previous treatment for this breast cancer;
7. Patients must have at least one measurable disease according to RECIST 1.1;
8. ECOG (Eastern Cooperative Oncology Group) performance score of 0-1 points;
9. LVEF≥55%;
10. Normal ECG;
11. Bone marrow function:absolute neutrophil count (ANC)≥2.0×109/L，platelets≥100×109/L，hemoglobin ≥90g/L。
12. Hepatic function：alanine aminotransferase(ALT) and aspartate aminotransferase(AST) ≤1.5×ULN，serum total bilirubin≤ ULN;
13. Renal function：serum creatinine≤1.5×ULN； Coagulation function：the international standardized ratio (INR) ≤1.5×ULN, prothrombin time (PT) or the activated partial thrombin time (APTT) ≤1.5×ULN.

Exclusion Criteria:

1. New York Heart Association (NYHA) class ≥Ⅱ heart failure.
2. Known or suspected hypersusceptibility to any agents used in the treatment protocol.
3. Need to Concurrent treatment with any other anti-cancer therapy considered by the investigator.
4. participating in other clinical trials within 4 weeks before this study.
5. Serious heart disease, including but not limited to:

1) Significant ventricular arrhythmia or high degree atrioventricular block (Mobitz II or third degree atrioventricular block); 2) unstable angina; 3) clinically significant heart valve disease; 4) Electrocardiogram shows transmural myocardial infarction; 5) Uncontrolled hypertension. 6. Uncontrolled diabetes. 7. Severe or uncontrolled infection. 8. Hepatitis b surface antigen positive, or hepatitis c virus antibody positive, or human immunodeficiency virus (HIV) antibody positive.

9. Active malignancy, other than adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin，within the past 5 years.

9）Women who are pregnant , breastfeeding ,or refuse to use adequate contraception prior to study entry and for the duration of study participation.

10）Other conditions considered to be inappropriate to be enrolled by the investigator.
Mode of Delivery on Newborn Hearing Test

Neonatal hearing screening may fail due to some perinatal and neonatal factors. It is well known that false positivity increases cost and maternal anxiety and anxiety in the neonatal hearing screening. The effect of the type of delivery to hearing screening is not yet clear. The first automated mode of delivery of babies born in Turkey auditory brainstem response (SAD's), the authors aimed to evaluate the effects of the test results and false positive rate.

newborns were evaluated with brainstem response test. The AABR test was performed before patients were discharged. Perinatal and neonatal variables and AABR test results were recorded retrospectively.


Eligibility Criteria:
Inclusion Criteria:

* records of birth process and
* pregnancy test results of newborns.

Exclusion Criteria:

* newborn;
* She was in a neonatal intensive care,
* congenital / chromosomal anomaly,
* undergoing congenital cmv infection,
* facial / ear deformity,
* families with hearing problems,
* those with hyperbiliromyemia,
* \<12 hours after delivery,
* maternal infection,
* dm,
* recurrent abortion,
* smoking,
* plesanta previa,
Carbetocin vs. Oxytocin: In-vitro Myometrial Contractions With and Without Oxytocin Pre-treatment

The purpose of this study is to compare the ability of an isolated sample of uterine muscle tissue (in a tissue bath) to contract in the presence of various drugs. The drugs studied--uterotonics--are typically used to contract the uterus when a pregnant patient continues to bleed after delivery. Oxytocin is an old standard, but seems to suffer from a desensitization phenomenon. Carbetocin, a similar drug, has recently been suggested to clinicians as a replacement for oxytocin directly after certain types of Cesarean section.

The investigators will be testing isolated uterine muscle samples after pre-treatment with oxytocin OR nothing (control) to increasing concentrations of oxytocin OR carbetocin. Contractile measures will be measured and compared between all groups. The investigators hypothesize that oxytocin pre-treatment will reduce contractions in both oxytocin- and carbetocin-induced contractions, and oxytocin and carbetocin will induce different patterns of contractions.

Postpartum hemorrhage (PPH) is a major cause of maternal mortality and morbidity. In 80% cases of PPH, the primary cause is failure of the uterus to contract after delivery of the baby, which then requires further treatment of the mother with uterotonic drugs (drugs used to contract uterus and thus prevent bleeding).

Patients participating in this study will be asked to donate a very small sample of uterine tissue during Cesarean section, which will be tested in the laboratory for the ability to contract in response to the uterotonics oxytocin and carbetocin. We will seek to better understand the effects of these drugs by comparing their contractile capability in isolated uterine tissue.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age 37-41 weeks
* Non-laboring patients, not exposed to exogenous oxytocin
* Patients requiring primary or first repeat Cesarean section
* Cesarean section under spinal anesthesia

Exclusion Criteria:

* Patients who require general anesthesia
* Patient who had previous myometrial surgery or more than one previous Cesarean section
* Patients with placental anomalies
* Emergency Cesarean section in labor
* Patients with multiple pregnancy (twins, etc.)
IL-1β and S1P Levels After Periodontal Therapy: A Split-Mouth Study

This randomized split-mouth clinical trial aimed to evaluate the changes in interleukin-1 beta (IL-1β) and sphingosine-1-phosphate (S1P) levels in gingival crevicular fluid (GCF) following non-surgical periodontal therapy (NSPT) in patients with stage III periodontitis. A total of 17 systemically healthy, non-smoking individuals were included. For each patient, three diseased and three healthy periodontal sites were selected, totaling 51 diseased and 51 healthy sites for biochemical and clinical evaluation.

GCF samples and clinical periodontal parameters were collected at baseline, one month, and three months after NSPT. The levels of IL-1β and S1P were quantified using enzyme-linked immunosorbent assay (ELISA). The study also investigated the correlation between biomarker levels and clinical indicators of periodontal disease severity, such as probing depth and clinical attachment level.

Diseased sites were selected based on the most severe clinical findings, including probing depth (PD) of ≥6 mm, clinical attachment level (CAL) of ≥5 mm, and the presence of bleeding on probing (BOP). Healthy sites were defined by PD ≤3 mm, no clinical attachment loss, absence of radiographic bone loss, and BOP negativity. All selected sites were non-adjacent and distributed throughout the oral cavity to reduce regional bias.

This study also aimed to explore site-specific changes in biomarker expression over time and assess the correlation between GCF IL-1β/S1P levels and clinical indicators of periodontal disease severity and healing response. All GCF sampling was repeated from the same sites at each time point. Control (healthy) site sampling was done at baseline and 3 months, while diseased site sampling was conducted at baseline, 1 month, and 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 45 and 60 years
* Systemically healthy individuals with no known systemic conditions
* Non-smokers or former smokers who had quit at least two years prior
* Diagnosed with Stage III periodontitis according to the 2017 World Workshop Classification
* Presence of at least three diseased sites with probing depth (PD) ≥ 6 mm, clinical attachment level (CAL) ≥ 5 mm, and bleeding on probing (BOP \[+\])
* Presence of at least three periodontally healthy sites with PD ≤ 3 mm, no CAL, and no BOP
* No periodontal treatment within the last 6 months
* Provided written informed consent

Exclusion Criteria:

* Presence of systemic diseases known to affect periodontal status (e.g., diabetes mellitus, cardiovascular disease, autoimmune disorders)
* Use of antibiotics or anti-inflammatory medications within the last 6 months
* History of periodontal surgery within the past 12 months
* Pregnant or lactating women
* Current smokers or individuals who quit less than two years ago
* Sites with endodontic lesions, caries extending to the cervical area, trauma-related gingival recession, or bone loss due to non-periodontal causes
* Undergoing orthodontic treatment during the study period