cyrilzakka/clinical-trials huggingface dataset:
Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer

The purpose of this trial was to see how well a new trial drug (degarelix) worked on lower urinary tract symptoms (also known as LUTS) in prostate cancer patients as compared to how a standard drug hormonal treatment worked on the same symptoms. The advancement/worsening of prostate cancer may be associated with LUTS and the symptoms may impact the ability to urinate normally and thereby the quality of life for these patients.

Patients were randomly selected (like flipping a coin) to receive either degarelix or standard hormone therapy (combination of goserelin and bicalutamide) for a 3 month treatment period. During this period the relief of urinary symptoms was evaluated via a questionnaire filled in by patients and addressing the severity and frequency of their symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Patient has given written informed consent before any trial-related activity is performed
* Has a confirmed prostate cancer in which this type of treatment is needed.

Exclusion Criteria:

* Previous treatment for prostate cancer
* Previous trans-urethral resection of the prostate
* Current use of 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
* Patients in need of external beam radiotherapy to be started at the same time as hormone therapy
* Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT interval over 450 msec., Torsades de Pointes or use of certain medications with potential risk)
* History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
* Hypersensitivity towards any component of the investigational product
* Other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer.
* Clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.
Study of Lipid Mediators in Chronic Postoperative Pain - LICP

This interventional prospective study aims firstly to investigate variations in lipid levels in blood samples and their potential relationship with the duration and/or intensity of post-operative pain. Secondly, it aims to investigate the activation of peripheral blood mononuclear cells and neutrophils in patient blood samples. The study will enrol women aged 18 years or older who have been newly diagnosed with primary invasive or non-invasive breast cancer requiring surgical removal of the tumour, with or without axillary surgery.

The main objectives of the study are To assess whether there is an association between circulating levels of lipid mediators and chronicity (\> 3 months) of postoperative pain after breast cancer surgery.

To assess whether circulating levels of lipid mediators can predict chronicity of postoperative pain in breast cancer surgery.

To assess the existence of an association between resected tissue levels of lipid mediators and chronicity of postoperative pain in breast cancer surgery.

To assess whether tissue levels of lipid mediators can predict chronicity of postoperative pain in breast cancer surgery.


Eligibility Criteria:
Inclusion Criteria:

* Women older than 18 years
* Newly diagnosed primary invasive or non-invasive breast cancer, requiring surgical excision of the tumor, with or without axillary surgery
* Able to give informed consent

Exclusion Criteria:

* Men
* Women aged less than 18 years
* Pregnant women
* History of major psychiatric disorders
* Previous breast or axillary surgery, recurrent disease or detectable metastatic disease at the time of diagnosis
* Unable to give informed consent
A Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase III Clinical Trial to Compare the Safety and Efficacy of DWP450 Versus Botox® in Treatment of Post Stroke Upper Limb Spasticity

Purpose: This study is a Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase III Clinical Trial to Compare the Safety and Efficacy of DWP450 Versus Botox® in Treatment of Post Stroke Upper Limb(wrist, finger, elbow, thumb)Spasticity.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female adult patients
2. ≥ 6 weeks since the last stroke

Exclusion Criteria:

1.Patients with diagnosed neuromuscular disorders such as Lamber-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis.
The Benchmark Clinic: An Interdisciplinary Comprehensive Care Model for People With Parkinson Disease

The purpose of this study is to determine if an interdisciplinary clinic can help people with Parkinson's disease care for themselves, improve their ability to follow recommended treatments, and have fewer problems like falls or visits to the emergency room.

Participants will be randomly assigned to receive either care from the interdisciplinary clinic or standard neurological specialist care.

This study involves questionnaires both before and 3 months after participation in a one time interdisciplinary care clinic or standard care depending on which type of care the participant is randomized to. Participants will be in the study for up to 6 months. The study will end upon completion of questionnaires about 3 months after treatment with the interdisciplinary care clinic or standard care.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Parkinson's Disease over the age of 30,
* Caregiver willing to also participate.
* Must be able to provide consent.

Exclusion Criteria:

-Atypical Parkinsonism
A Problem-Solving Intervention for Family Caregivers in Palliative Oncology

In congruence with the National Cancer Institute's commitment to supporting families of individuals with cancer across the full disease trajectory, the investigators seek to examine the feasibility of a technologically-mediated problem-solving intervention designed to improve the quality of life and decrease the psychological distress of family caregivers of cancer patients receiving outpatient palliative care. Investigators involved in this mixed methods pilot study will collect and analyze both quantitative and qualitative data, which will subsequently inform a large-scale randomized clinical trial of the problem-solving intervention.

Palliative oncology providers are ideally situated to improve the cancer journey for the millions of family members and friends who are vital to the care of seriously ill patients. In recent decades, the primary setting for cancer care has shifted from the hospital inpatient unit to the outpatient clinic, leaving family caregivers responsible for providing the majority of patient care in the home, often with little support or preparation. The numerous stressors associated with family caregiving often give rise to caregiver anxiety, depression, fatigue, neglect of self-care and, for particularly strained caregivers, psychological symptoms that mirror those experienced by trauma survivors. In congruence with the National Cancer Institute's commitment to supporting families of individuals with cancer across the full disease trajectory, the investigators seek to examine the feasibility of a technologically-mediated problem-solving intervention designed to improve the quality of life and decrease the psychological distress of family caregivers of cancer patients receiving outpatient palliative care. Specifically, the investigators aim to 1) examine the feasibility of the intervention relative to recruitment, randomization, retention, and fidelity to core intervention components; 2) investigate the impact of the intervention on family caregiver anxiety, depression, and quality of life; and 3) explore the benefits and challenges associated with the intervention from the perspective of participants. To accomplish these aims, investigators will recruit and randomly assign 82 family caregivers of cancer patients receiving outpatient palliative care into two groups (usual care and intervention) and collect quantitative and qualitative data, which will be analyzed to inform a future large-scale randomized clinical trial of the problem-solving intervention.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older,
* access to an Internet-connected device that will support videoconferencing software

Exclusion Criteria:

* Younger than 18 years of age,
* lack of access to an Internet-connected device that will support videoconferencing software
OrganOx Metra® New Enrollment PAS

The objective of the OrganOx metra® New Enrollment Post-Approval Study is to collect data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on the OrganOx according to the current indications for use in the real-world setting.

The OrganOx metra® New Enrollment Post-Approval Study is a multi-site, single arm, unblinded post-approval study that will enroll deceased DBD or DCD donor liver and adult liver transplant recipients according to the current indication and that match the eligibility criteria below.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years of age or greater
* Subject is registered as an active recipient on the UNOS waiting list for liver transplantation
* Subject, or legally authorized representative, is able and willing to give informed consent and HIPAA authorization
* Subject is able and willing to comply with all study requirements (in the opinion of the Investigator)

Exclusion Criteria:

* Subject requiring all of the following at the time of transplantation:

  1. Oxygen therapy via a ventilator/respirator
  2. Inotropic support
  3. Renal replacement therapy
* Subject has acute/fulminant liver failure (UNOS status 1A)
* Subject planned to undergo simultaneous transplantation of more than one organ (e.g., liver and kidney) from the same liver donor
* Subject is pregnant (as confirmed by urine or serum pregnancy test) or nursing
* Concurrent enrollment in another clinical study. Subjects enrolled in clinical studies or registries where only measurements and/or samples are taken (no test device or test drug) are allowed to participate.
Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder

The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility Criteria:
Inclusion Criteria:

Open-Label

* A diagnosis of Bipolar I Disorder, Most recent episode Manic (296.4x), or Bipolar I Disorder, Most Recent Episode Depressed (296.5x), or Bipolar I Disorder, Most recent Episode Mixed (296.6x), with or without psychotic features, as defined by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV)
* At least 1 manic, depressed, or mixed episode in the 2 years prior to the index episode.
* Able to understand and comply with the requirements of the study.

Exclusion Criteria:

Open-Label

* Diagnosis of an anxiety disorder as defined by DSM-IV, which was treated with medication within the past year.
* Known intolerance or lack of response to quetiapine fumarate or to the assigned mood stabilizer, as judged by the investigator.
* Previously randomized into this study or D1447C00126
Laparoscopic Lateral Mesh Suspension for Pelvic Organ Prolapse

This study is aimed to share our clinical experience in an uterine-preserving laparoscopic lateral suspension of apical prolapses with mesh operation after minor modifications in technique. Transperineal ultrasonography and several questionnaires are used for objective and subjective outcomes.

Vaginal length, bladder neck mobility and pelvic floor biometry with anteroposterior hiatal diameter and pelvic organ descent measurements are measured by transperineal ultrasonography to assess anatomic success in the preoperative and at postoperative 18th months if available.

Female Sexual Function Index (FSFI), Michigan Incontinence Severity Index (M-ISI), Prolapse Quality of Life questionnaire (PQoL), Pelvic Organ Prolapse Symptom Score (POP-SS) and Visual Analog Score (VAS) are used to assess subjective success in the preoperative and at postoperative 18th months if available.

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Eligibility Criteria:
Inclusion Criteria:

* \>18 years old symptomatic women with pelvic organ prolapse needing surgery.
* Patients who are not comfortable with using or refusing pessary
* Refusing sacrocolpopexy due to its serious surgical risk

Exclusion Criteria:

* Patients who prefer sacrocolpopexy
* Any cue for gynecologic oncological condition
* Patients who approves Le Fort colpocleisis among who does not have any sexual intercourse
Risk Factors for the Leakage of Anticancer Drugs to Systemic Circulation by Transcatheter Arterial Chemoembolization

Hepatocellular carcinoma (HCC) is the most common malignant tumor of the liver. Transcatheter arterial chemoembolization (TACE) is the traditional method for the palliative management of patients with HCC. Few previous studies had demonstrated that the serum level of anticancer drug from patients treated by TACE was similar to those treated by systemic chemotherapy. The defense ability of the patient treated by TACE may thus be influenced by the leakage of anticancer drug to the systemic circulation. Since more than 80% patients with HCC also have liver cirrhosis, the toxicity for those anticancer drugs with hepatic transformation will be increased caused by the cirrhotic liver. The severity of pancytopenia in cirrhosis will be exacerbated by the effect of bone marrow suppression caused by anticancer drugs. Patients are at high risk for infection and hemorrhage. Therefore, it is of clinical importance to prevent or decrease the leakage of anticancer drugs to systemic circulation in patients treated by TACE. The procedures of TACE performed by previous studies were not constant and the distributions of tumor vessels were not evaluated in detail. The possible risk factors for the leakage of anticancer drug have not been investigated. This project will collect 60 patients with HCC including 30 patients with hepatitis B and 30 patients with hepatitis C. The blood levels of anticancer drugs (epirubicin, mitomycin C and cisplatin) will be determined within one hour and at the third day after TACE.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hepatocellular carcinoma caused by hepatitis B or C who will be treated by TACE

Exclusion Criteria:

* Previously treated by antiviral drugs for hepatitis B or C
Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-935

The purpose of this study is to characterize the safety and tolerability profile of TAK-935 in healthy participants when administered as a single dose of oral solution at escalating dose levels.

The drug being tested in this study is TAK-935. TAK-935 is being tested to find a safe and well-tolerated dose and to assess how TAK-935 is processed by the body. This study will look at side effects and lab results in people who take TAK-935 and is designed as a randomized dose-rising study.

The study will consist of 6 Cohorts with 8 participants in each Cohort. In each Cohort, 6 participants will receive a single dose of TAK-935 and 2 participants will receive placebo after a 10-hour fast. The starting dose will be 15 mg followed by planned doses of 50, 200, 600, 900 and not to exceed 1350 mg in subsequent cohorts.

This single-center trial will be conducted in the United States. The overall time to participate in this study is up to 51 days. Participants will make 2 visits to the clinic, including one 7-day period of confinement to the clinic. All participants will be contacted by telephone 14 days after the dose of study drug for a follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Is a healthy male or female adult who is 19 to 55 years of age inclusive at the time of informed consent.
2. Weighs at least 45 kg and has a body mass index (BMI) between 18.0 and 30.0 kg/m\^2, inclusive at the Screening Visit.

Exclusion Criteria:

1. Has uncontrolled, clinically significant neurological (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, immunologic, endocrine disease, or psychiatric disorder, or other abnormality.
2. Has a known hypersensitivity to any component of the formulation of TAK-935.
3. There is any finding in the participant's medical history, significant results from physical examination, or safety laboratory tests.
Motivational Interviews for Incarcerated Teens - 1

The purpose of this study is to test the efficacy of an individual motivational interview for reducing alcohol and marijuana-related harm as well as alcohol and marijuana use in incarcerated teens.

The objective of this research is to investigate ways to enhance motivation for treatment and effectively reduce substance abuse among juvenile offenders. Motivational intervention (MI) as preparation for residential treatment and for persons (including teens) with little motivation to change has been effective in reducing substance abuse. Thus, MI designed for delinquent youths who are required to attend substance abuse treatment may prove efficacious.

In this proposed randomized trial, a one-way design (MI + Standard Care \[SC\] v. Attention Control \[AC\] + SC) will be used to determine whether MI enhances subsequent treatment participation and reduces substance-related problems post discharge in substance using, delinquent youths. Teens will also receive a booster session of MI or AC prior to discharge. Primary outcome variables include alcohol and marijuana use, as well as related behaviors (illegal activity, sex or injuries while drunk or high). It is hypothesized that in comparison to teens receiving AC, youths receiving MI will participate more (by therapist and teen ratings) in SC and will show the lowest levels of heavy substance use and related problems after discharge. It is hypothesized that these effects will be mediated by stage of change, drug effect expectancies and self-efficacy.

This study will extend previous research by evaluating the use of MI with substance abusing teens in a correctional facility, and by expanding outcome measures to include alcohol and marijuana-related risk behavior (such as injuries and illegal activity when drunk or high) in this population. The development of effective interventions for substance using juvenile offenders has the potential to reduce substance abuse and crime in this population.

Eligibility Criteria:
Inclusion Criteria:

Teens will be included if they meet any of the following criteria: 1) in the year prior to incarceration they used marijuana regularly (at least monthly); 2) in the year prior to incarceration they drank regularly (at least monthly) or binged (\>=5 for boys; \>=4 for girls) over any two week period or less; 3) they used marijuana or drank in the 4 weeks before the offense for which they were incarcerated; or 4) they used marijuana or drank in the 4 weeks before they were incarcerated.

Exclusion Criteria:

Those teens sentenced for less than 4 months or greater than 12 months will be excluded from participation. We estimate that during year 1 we will exclude an additional 25% of youths because they will have previously participated in the study, and at year 2 we anticipate excluding an additional 49% of youths based on prior participation in the study.
RT for Cervical Adenocarcinoma/adenosquamous Carcinoma

The purpose of this study was to retrospectively analyze patients with cervical adenocarcinoma/adenosquamous carcinoma who had been admitted to our hospital. Approximately 500 cases of cervical adenocarcinoma were planned to be included, summarize the disease characteristics, treatment regimens, and recurrence patterns of the patients, and analyze the association between treatment regimens and recurrence patterns and prognosis.

This study is a retrospective analysis. The keywords "cervical adenocarcinoma" and "cervical adenosquamous carcinoma" were used to search for patients with cervical adenocarcinoma and cervical adenosquamous carcinoma admitted to the Department of Radiotherapy, Peking Union Medical College Hospital from 2009 to 2024. The clinical information, pathological information, and treatment methods of the patients in the medical records were collected, and the date of death, cancer recurrence, and metastasis were confirmed by querying medical records or conducting telephone interviews. The included cases were divided into the radical surgery group and the concurrent chemoradiotherapy group according to the treatment mode. The pathological types were reclassified according to the IECC 2018 standards, and the associations between pathological types, treatment regimens, recurrence patterns (local recurrence, distant metastasis, recurrence within the irradiation field, recurrence outside the irradiation field), and prognosis were analyzed. For patients with residual local cervical tumors after synchronous chemoradiotherapy or recurrence within the field after radiotherapy, the previous genetic test results of the patients were retrieved, their genomic characteristics were analyzed, and compared with the TCGA database. If the patient has not undergone genetic testing before, pathological sections of the patient will be obtained from our hospital for whole exome sequencing, and the testing items include.

Eligibility Criteria:
Inclusion Criteria:

a) Pathological diagnosis of cervical adenocarcinoma; b) Age 18-80 years old; c) Karnofsky score≥60 points; e) Complete blood count, and comprehensive metabolic panel meet the conditions for CCRT or RT after surgery; f) No metal implants in the body, and can perform MRI examination; g) Willing to participate in this study and provide written informed consent. -

Exclusion Criteria:

1. Patients who have received pelvic radiotherapy before;
2. Patients whose target tumors have been treated before (chemotherapy, immunotherapy, surgical treatment, etc.);
3. Allergy to iodine contrast agent;
4. Participating in other clinical studies that may affect the results of this study (determined by the principal investigator);

f) Serious diseases that may significantly affect compliance with clinical trials, such as unstable heart disease, kidney disease, chronic hepatitis, poorly controlled diabetes, and mental illness that require treatment; g) Other situations that the investigator believes are not suitable for participation in this clinical study.