cyrilzakka/clinical-trials huggingface dataset:
A Study Evaluating the Safety, Pharmacokinetics and Anti-Tumor Activity of ABBV-176 in Subjects With Advanced Solid Tumors Likely to Express Prolactin Receptor (PRLR)

This is an open-label, Phase I, dose-escalation study to determine the maximum tolerated dose (MTD) and the recommended phase two dose (RPTD), and to assess the safety, preliminary efficacy, and pharmacokinetic (PK) profile of ABBV-176 for participants with advanced solid tumors likely to express Prolactin Receptor (PRLR). The study will consist of 2 cohorts: Dose Escalation and Expanded Recommended Phase 2 Dose.


Eligibility Criteria:
Inclusion Criteria:

* Participant has histological confirmation of a locally advanced or metastatic solid tumor of a type associated with Prolactin Receptor (PRLR) expression that has progressed on prior treatment, is not amenable to treatment with curative intent, and has no other therapy options known to provide clinical benefit or the subject is ineligible for such therapies.
* Dose Escalation Cohort: must have breast cancer, colorectal cancer, adrenocortical carcinoma, chromophobe renal cell carcinoma.
* Expanded Cohort: must have breast cancer.
* Participant must consent to provide the following for biomarker analyses:
* Dose Escalation Cohort: archived tumor tissue or fresh tumor biopsy.
* Expanded Cohort: archived tumor tissue and fresh tumor biopsy.
* Participant has Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Participant has adequate bone marrow, renal, and hepatic function.

Exclusion Criteria:

* Participant received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic, or any investigational therapy within 21 days before Study Day 1; participant received palliative radiotherapy or small molecule targeted anti-cancer agents within 14 days of Study Day 1.
* Participant has prior exposure to any pyrrolobenzodiazopine-containing agent
* Participant has unresolved, clinically significant toxicities from prior anticancer therapy, defined as greater than Grade 1 on Common Terminology for adverse events.
* Participant has clinically significant uncontrolled conditions.
* Participant has a history of major immunologic reaction to any Immunoglobulin G (IgG).
* Participant has received more than 4 prior lines of systemic cytotoxic therapy (not including neo-adjuvant or adjuvant therapy).

  * For prior cytotoxic therapy, treatment for 1 full cycle or less will not be considered as prior therapy unless the patient experienced progression of disease while on that therapy.
* Participant has a history of \>= grade 3 AST, ALT, or bilirubin increase or has extensive liver resection (i.e., left lobe resection).
* Participant has a history of cholecystitis (subject with history of cholecystectomy will not be excluded), or has active gallbladder disease.
Adjunctive Use of Fute (Flupentixol) in Multi-acting Receptor-targeted Antipsychotics Treated Schizophrenia Patients

Fute (Flupentixol) combined with MARTAs (Multiple-Acting Receptor Targeted Antipsychotics) drugs has its clinical efficacy toward positive symptoms and might reduce the metabolic syndrome-related factors in patients. This study is the first clinical trial to explore the treatment of patients with flupentixol combined with MARTAs. However, due to research limitations, the number of patients who participated in the clinical trial is small, and it depends on subsequent larger-scale clinical trials for more in-depth verification.

Objectives

The effects of adjunctive Fute (Flupentixol) with MARTAs (Multiple-Acting Receptor Targeted Antipsychotics) on the metabolic profiles of patients and clinical efficacy of treatment in schizophrenia.

Methodology

It is expected to be admitted to patients with schizophrenia who are over 20 years old and are being treated with MARTAs antipsychotics due to poor treatment efficacy or significant weight gain after use, poor blood sugar control, and other metabolic syndrome-related problems, but Patients who do not meet the medication standards for diabetes or hyperlipidemia, and are willing to accept additional use of Flupentixol after evaluation by the physician.

To compare whether the original MARTAs dose can be effectively reduced after additional use of Flupentixol for at least 12 weeks, whether the symptoms of psychosis have improved, and whether the various factors of metabolic syndrome have improved.

Number of patients

It is estimated that 30 subjects will be recruited to participate in this clinical trial. This report is an interim report with the results of 15 subjects.

Diagnosis and main criteria for inclusion

Patients suffering from schizophrenia who are over 20 years old and are using MARTAs antipsychotics.

Test product, dose and mode of administration, batch number

Fute F.C. Tablets (Flupentixol), the clinically recommended dosage should be adjusted according to the individual conditions of the patients. Generally speaking, a low dose should be administered at the beginning. Then the dosage is increased according to the treatment response to achieve the appropriate curative effect as soon as possible. The maintenance dose is usually administered as a single dose in the morning, and the maintenance dose is usually 5-20 mg/day.

The initial dose is 3-15 mg/day, divided into 2-3 administrations, and can be increased to 40 mg/day if necessary.

Eligibility Criteria:
Inclusion Criteria:

* Patients who suffer from schizophrenia are over 20 years old and are using MARTAs antipsychotics.

Exclusion Criteria:

* \>65y aged Patients.
* \>Other non-schizophrenia disease.
Comparative Effectiveness of Different Surgical Approaches for Giant Pituitary Adenomas

The surgical treatment strategy for giant invasive pituitary adenoma is one of the current hot spots in the field of clinical research on pituitary adenoma. A comprehensive literature search resulted in numerous previous studies to investigate the efficacy, advantages and disadvantages of different surgical options.

A single approach (transnasal or craniotomy) is theoretically less invasive and has a shorter hospital stay for the patient, but may result in postoperative bleeding due to residual tumor and damage to the intracranial vessels adhering to the tumor.

The advantage of the combined approach is that the tumor can be removed to the greatest extent possible. In addition, postoperative suprasellar hemorrhage can be prevented by careful hemostasis or intracranial drainage by the transcranial team if necessary. In this way, the risk of postoperative bleeding due to residual tumor can be significantly reduced.

In some cases, waiting a few months after the initial surgery for a second-stage procedure may also be an option when the patient's condition does not allow for a combined access procedure, when the tumor is hard, or when the blood preparation is insufficient. However, staged surgery increases the financial burden on the patient, and local scar formation may make second-stage surgery more difficult and decrease the likelihood of endocrine remission of functional pituitary tumors.

Given the complexity of the treatment of giant invasive pituitary adenoma, there is a need to conduct studies comparing the combined transnasal cranial approach, the single access transnasal or cranial approach, and the staged approach simultaneously to assess whether the combined transnasal cranial approach is superior to the single access transnasal or cranial approach or the staged approach in improving the tumor resection rate in giant invasive pituitary adenoma.


Eligibility Criteria:
Inclusion Criteria:

* Giant pituitary adenoma (\> 4cm in diameter)

Exclusion Criteria:

* most of the tumor were in the sellae, sphenoidal sinus or clivus.
* patients with craniopharyngioma or meningioma.
A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Combined Versus Separate Injections in People With Overweight or Obesity

This study will compare two different ways of giving cagrilintide and semaglutide for treating overweight and obesity. The medicines will either be given together in 1 injection or as 2 separate injections.

The aim of the study is to find out how the different ways of injection affect the level of the medicines in the blood.

For the first 14 weeks of the study, participants will get cagrilintide and semaglutide as 2 separate injections. Then participants will either switch to getting the medicines as a combined injection or continue to get the separate injections for 8 weeks. Which treatment participants get after the first 14 weeks is decided by chance.

Participants will get the study medicines once a week for 22 weeks. A study nurse at the clinic will inject the medicines with a thin needle in participants stomach area.

The study will last for about 8 months.Participants will have 28 clinic visits with the study staff. For 4 of these visits, participants will stay in the clinic for 5 nights.

Participants will have blood drawn at 21 visits. Participants will have clinical assessments and participants will be asked about their health, medical history and habits including mental health questionnaires.

For women: Participants must not be able to become pregnant if they wish to participate in this study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of non-childbearing potential (NCBP)
* Aged 18-55 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 27.0 and 39.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator

Exclusion Criteria:

* Previous participation in trial(s) with an amylin analogue unless documented that the subject was assigned to placebo treatment. Participation is defined as randomisation
* Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
Cochlear Implants Registry in Thailand Project

The purpose of this study is to determine the outcome of cochlear implant including post operative hearing ability, developing of language, complication from cochlear implant, quality of life, and success factor of cochlear implant.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent surgery with cochlear implant

Exclusion Criteria:

* Patients who reject to participate with this project
Dietary Intervention Trial Targeting Metabolic Syndrome After Kidney Transplantation

Kidney transplant recipients (KTR) have a considerably lower life expectancy as compared with the general population, primarily due to a high prevalence of cardiovascular diseases. KTR often develop an unfavourable cardio-metabolic risk profile characterized by weight gain, metabolic syndrome and post-transplantation diabetes mellitus (PTDM). In general, nutrition plays a key role in both the prevention and treatment of these cardio-metabolic derangements.

However, in KTR most RCT's with a dietary intervention, failed to show significant improvement in cardio-metabolic health. This at least questions the efficacy of the diets of these intervention, which relied on general or diabetes guidelines, after kidney transplantation. KTR not only face a high cardio-metabolic risk, but also have a high risk for malnutrition and muscle mass depletion. More knowledge is required to determine the optimal diet and macronutrient composition for improvement of the cardio-metabolic risk factors in the context of the high malnutrition risk. In this regard, observational studies point towards the needs for a higher protein intake for better patient outcomes. Therefore, in this study, the investigators will examine if a high-protein, carbohydrate-reduced diet is more effective than a diet in line with the Dutch Dietary Guidelines for improvement of cardio-metabolic risk factors and for improvement of the body composition in KTR.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Given informed consent.
* At least 6 months after kidney transplantation.
* Stable renal function with an estimated glomerular filtration rate (eGFR) \> 30 mL/min.
* Raised systolic blood pressure (≥130 mmHg) and at least two more features of metabolic syndrome: central obesity (waist circumference ≥102 for men and ≥88cm for women), elevated triglycerides (≥ 1.7 mmol/L), reduced HDL-C (\< 1.0 mmol/L for men and \< 1.3 mmol/L for women) or on drug treatment for reduced HDL, elevated plasma glucose (≥ 5.6 mmol/L) or on drug treatment for elevated glucose9.
* Approval by nephrologist for participation in the study.

Exclusion Criteria:

* Active medical illness, including rejection of the graft.
* Psychopathology or serious cognitive impairment.
* Necessity to follow specific dietary measures for health purposes that conflict with the study diets.
* Use of insulin or sulfonylurea (SU)-derivates.
* Language barrier.
* Pregnancy or lactating.
* Serum potassium \> 5.0 mmol/L that requires dietary measures.
* Moderate or severe malnutrition (Patient-Generated Subjective Global Assessment (PG-SGA) stage B or C). In this case, patient will be referred to a renal dietician.
* Participation in other intervention trials.
Prospective Study of the Impact of Insulin Pump Therapy in Young Children With Type 1 Diabetes

The purpose of the study is to examine glycemic and neuropsychological outcomes in very young children with Type I diabetes who are being started on insulin pumps and to compare their outcomes to children who are not utilizing insulin pumps. We propose to assess 40 children with IDDM under 5 years of age. 10 patients examined will be using multiple daily injections with basal glargine, 10 will be using NPH or Lente and rapid-acting insulin, and 20 will be examined prior to and 12 months after the implementation of insulin pump therapy. These subjects will be recruited and followed because they are currently undergoing treatment for Type 1 diabetes. Children will be recruited based upon the insulin regimen that they and their primary diabetes physician have chosen to utilize clinically. Insulin regimens will not be changed by the study team. Outcome measures will examine: glycemic outcomes (overall control, blood sugar variability), cognitive outcomes, parenting Stress, and changes in diet.


Eligibility Criteria:
Inclusion Criteria:

1. Children with Type I diabetes:
2. Children must be 5 years of age or less at the time of entry into the study.
3. Children must have had a diagnosis of type I diabetes for at least 1 year at time of entry.
4. Children must be receiving two or more insulin injections daily.

Exclusion Criteria:

1. Children will be excluded if they have additional medical problems requiring treatment with agents known to affect blood glucose such as steroids or L-asparaginase.
2. Children must not have any other chronic illness in addition to diabetes.
Mobility & Vitality Lifestyle Program

MOVE UP is a weight management program for adults 60-75 in community settings led by trained community health workers.

MOVE UP is a weight management program designed for adults who desire to lose weight and improve their overall health.

Topics include: Overall Health, Weight management, Healthy eating, Behavior change, Physical activity

Eligibility Criteria:
Inclusion Criteria:

1. Age 60-75 at time of program start
2. Self-reporting \< 60 minutes per week of moderate structured physical activity
3. BMI \>= 30 but \< 40 for screen. In person measurement on site will allow for 27-45 as inclusion criteria.
4. Able to consent for participation and data collection
5. Medical release before start of Weight Management
6. Ability to walk with or without an assistive device
7. Can regularly attend sessions
8. Has not had bariatric surgery over the past year, or current use of weight loss prescription drug.

Exclusion Criteria:

1. Uncontrolled diabetes mellitus (FBS \> 300 \& A1C \> 11%) \[to be assessed by physician on medical release\]
2. Uncontrolled hypertension (SBP \> 180/110) %) \[to be assessed by physician on medical release\]
3. Recent hospitalization (past 6 months)
4. Active treatment for cancer (other than non-melanoma skin cancer)
5. Significant visual or hearing impairment
6. Dementia/psychiatric disorder
7. Inability to communicate in English/lack of translator
A Study to Assess the Relative Bioavailability And Food Effect of a Tablet Formulation of GDC-0276 in Healthy Participants

This open-label, randomized, 4-way crossover study in healthy participants will determine the relative bioavailability of the tablet formulation relative to the capsule formulation and the effect of a high-fat and low-fat meal on the relative bioavailability of the tablet formulation.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index within the range 18.0 to 32.0 kilograms per meter squared (kg/m\^2), inclusive, and a minimum weight of 50.0 kg
* Male participants of reproductive potential must be and willing to continue using medically acceptable contraception and must avoid sperm donation from screening and for at least 90 days after the last study drug administration

Exclusion Criteria:

* Self-reported substance or alcohol dependence (excluding nicotine and caffeine) within the past 2 years, and/or participants who have ever been in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence
* Have used any prescription or over-the-counter (OTC) medication or supplement within 14 days or 5 times the elimination half-life (whichever is longer) before Day -1 until the end of their participation in the study
* Have used any vaccine within 7 days before GDC-0276 administration
* Female participants with a positive serum or urine pregnancy test or are breast feeding
* Donation or loss of more than 500 milliliter (mL) whole blood within 3 months preceding entry into the treatment period
* Blood transfusion within 30 days preceding entry into the treatment period
To Determine the Effectiveness of Saddle Block vs Spinal Anesthesia in TURP

To determine the effectiveness of saddle block vs spinal anesthesia in TURP.

This study is being conducted to determine the effectiveness of saddle block vs spinal anesthesia in terms of haemodynamic stability and Vasopressor usage.

Eligibility Criteria:
Inclusion Criteria:

* Patient with absolute contraindication of general anaesthsia
* Patients who gave consent and willing to be included in study
* Patient's having age range between 45 years to 65years
* Well controlled diabetes and hypertension
* ASA grade I \& II

Exclusion Criteria:

* Patients with absolute contraindications of regional anesthesia,
* Deformity of vertebral column,
* Thyroid disorder,
* Psychiatric illness,
* Neurological diseases,
* Alcohol addiction,
* Smoking,
* Ischemic heart diseases and
* Not willing to participate
Ketamine and Epigenetic Aging

This is a prospective, clinical pilot study (n=20) to evaluate the impact of a ketamine treatment for Major Depressive Disorder (MDD) or Post Traumatic Stress Disorder (PTSD) on epigenetic aging by the TruAge epigenetic age laboratory test.

Subjects with MDD or PTSD will have a series of six ketamine infusions over two to three weeks.

Eligibility Criteria:
Inclusion Criteria:

* Be 18-64 years old of any sex, gender orientation, and ethnicity
* Read, understand, and provide written informed consent in English,
* Meet criteria for a primary psychiatric diagnosis of Major Depressive Disorder (MDD) or Post-traumatic Stress Disorder (PTSD) for greater than 4 weeks,
* Have a history of at least 1 failed medication trial targeting MDD or PTSD
* Have a reliable form of transportation to lodging or home following the completion of each ketamine infusion treatment day,
* Be generally healthy, as assessed by medical history, physical examination (including vital signs), and clinical laboratory evaluations,
* Be of non-childbearing potential or utilizing an acceptable form of birth control (females-only)
* Report a pre-treatment symptom level of ≧15 on the PHQ-9 or ≧ 33 on the PCL-5
* Consent to participation in venipuncture, drug test, pregnancy test (for females) psychiatric evaluation, rating scale completion and ketamine infusion treatment series of six over the course of two to three weeks.

Exclusion Criteria:

* Delirium or dementia diagnosis,
* Unstable medical illness or clinically significant laboratory results,
* History of clinically significant cardiovascular disease or electrocardiogram (EKG) findings, or medical conditions that put the patient at high risk for possible cardiac side effects, or uncontrolled hypertension
* History of multiple adverse drug reactions,
* Current or past history of psychotic disorder or psychotic symptoms,
* Current manic symptoms,
* Active substance use disorders with the exception of nicotine and caffeine, within the past six months or any past history of ketamine or PCP abuse,
* Requirement of excluded medications that interact with ketamine,
* Pregnancy, breastfeeding or unacceptable means of birth control in a female of child-bearing age,
* Current acute suicidal or homicidal risk,
* Previous exposure to ketamine
Prescribing Lorazepam for IUD Insertion: Pilot Feasibility Study

The objective of this pilot study is to discuss the feasibility of prescribing lorazepam prior to IUD insertion and of measuring effect of lorazepam on anxiety and pain with Intrauterine Device (IUD) insertion. The target population for this study will be 25 adult participants scheduled for an IUD insertion at a UW Family Medicine residency clinic. Participants will be followed for 1 appointment visit.

The purpose of the research is to evaluate the feasibility of prescribing lorazepam and measuring its effect on anxiety and pain with IUD insertion. The descriptive data from this study will be used to offer guidance for how to implement a larger scale study in the future.

Primary endpoint: Assess preliminary differences in pain and anxiety scores pre-IUD insertion and post-IUD insertion using a Mann-Whitney U test. Participants will score their anxiety and pain levels pre-procedure and post-procedure using a 10cm visual analogue scale. This will be a one arm trial where all subjects will receive 1mg lorazepam and 800mg ibuprofen prior to the procedure.

Secondary endpoints

* Discuss if there was a difference in pain and anxiety scores among nulliparous (no previous childbirths) and multiparous (one or more previous childbirths) participants.
* Summarize recruitment rates, adherence to lorazepam prescription, completion rates of questionnaires and scales
* Discuss participant's experiences with taking lorazepam and participating in the study
* Assess investigator's experience with the trial via a focus group

Eligibility Criteria:
Inclusion Criteria:

* Participants who undergo IUD insertion and complete the visual analogue scales to rate their anxiety and pain level prior to the procedure and after the procedure.
* Participants must have a driver take them to their appointment if they take lorazepam prior to their arrival at the clinic.
* Participants must have a driver take them home after the procedure as well.
* Participants must consent to email communication since they will sign the consent forms electronically

Exclusion Criteria:

* Participants who do not show up for their appointment.
* Participants who receive cervical blocks or other analgesic method during IUD insertion.
* Participants who have a history of substance use disorder.
* Participants who are taking medications with a central nervous system (CNS) depressant effect (ex: opioids, benzodiazepines).
* Participants who are not able to sign an electronic consent form.
* Participants who do not have a driver to take them to their appointment and to take them home after the procedure.
* Participants who do not agree to sign consent forms electronically.