cyrilzakka/clinical-trials huggingface dataset:
Sonographic Measurement of Bladder Wall Thickness in Patients With Neurogenic Bladder Dysfunction

Video-urodynamic investigations are regarded as the current standard diagnostics for neurogenic bladder dysfunction in patients with spinal cord injury. This examination is exact, but time consuming, costly and associated with the risk of urinary tract infection.

In patients with lower urinary tract symptoms due to benign prostate hyperplasia, sonographic measurement of bladder wall thickness has been demonstrated to be able to replace urodynamic testing for the diagnosis of infravesical obstruction.

Hypothesis: measurement of bladder wall thickness in patients with neurogenic bladder dysfunction due to spinal cord injury is closely related to the known risk factors for upper urinary tract deterioration (bladder compliance, detrusor leak point pressure) in this group of patients and can therefore replace urodynamic examination in selected cases.


Eligibility Criteria:
Inclusion Criteria:

* neurogenic bladder dysfunction due to spinal cord injury
* ability to understand German language
* willingness and capability to undergo urodynamic testing
* age \> or = 18 years

Exclusion Criteria:

* acute urinary infection at the time of examination
* known bladder tumor or bladder stone
* age \< 18 years
* not capable to understand aim and purpose of the examination
Minirigid Versus Conventional Rigid Thoracoscopy in Undiagnosed Pleural Effusions

Consecutive patients who are planned to undergo a medical thoracoscopy for obtaining pleural biopsies will be enrolled in the study.

One hundred subjects will be randomized in 1:1 ratio to undergo thoracoscopy to the following groups:

Group A (mini-thoracoscopy) Group B (Conventional rigid thoracoscopy) Primary outcome: (a) diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions

A significant proportion of patients with pleural effusions remain undiagnosed after performance of diagnostic procedures including cytological and microbiologic analysis of the pleural fluid and closed pleural biopsies. In this study, the investigators plan to compare the yield and safety of mini-thoracoscopy and conventional rigid thoracoscopy with the larger diameter scope.

This is a prospective study that will be conducted at the Thoracic Endoscopy Suite of the Department of Pulmonary Medicine, PGIMER, Chandigarh.

Consecutive patients who are planned to undergo a medical thoracoscopy for obtaining pleural biopsies will be enrolled in the study

One hundred subjects will be randomized in 1:1 ratio to undergo thoracoscopy. The randomization sequence will be generated using a computer (in blocks of 10), and the allocation will be placed in opaque sealed envelopes. The patients will be randomized to the following groups:

Group A (mini-thoracoscopy): The mini-thoracoscope manufactured by Richard Wolf GmbH, Knettligen, Germany will be used. It has an outer diameter of 5.5 mm and a working channel diameter of 3.5 mm.

Group B (Conventional rigid thoracoscopy): The rigid thoracoscope manufactured by Richard Wolf GmbH, Knettligen, Germany will be used that has an outer diameter of 10 mm and channel internal diameter of 5 mm.

Primary outcome: (a) diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions.

Eligibility Criteria:
Inclusion Criteria:

* Medical thoracoscopy being performed for obtaining a pleural biopsy

Exclusion Criteria:

* PaO2/FIO2\< 300; Hemodynamic instability Myocardial infarction or unstable angina in the last 6 wk Lack of pleural space due to adhesions Uncorrected coagulopathy Failure to provide informed consent
Study of CX-4945 in Patients With Relapsed or Refractory Multiple Myeloma

This Phase 1 study of oral CX-4945 is designed to test the safety, tolerability, and highest safe dose level of this CK2 inhibitor in patients with relapsed or refractory multiple myeloma.

Elevated CK2 activity has been associated with malignant transformation and aggressive tumor growth. Over expression of CK2 has been documented in multiple types of cancers, including multiple myeloma, and inhibition of CK2 represents a potential therapeutic strategy to target a specific molecular defect perpetuating many cancers. CX-4945 has demonstrated potent inhibition of CK2 enzymatic activity. This study will evaluate the safety, pharmacokinetics, and pharmacodynamic effects of CX-4945 when administered to patients with multiple myeloma.

Eligibility Criteria:
Inclusion Criteria:

* Males or females at least 18 years of age
* Confirmed relapsed or refractory multiple myeloma after at least two prior lines of therapy.
* Measureable disease.
* Karnofsky Performance Status at least 60%
* Adequate liver and renal function and hematology laboratory values
* Female patients of child-bearing potential must have a negative pregnancy test.
* Signed informed consent.

Exclusion Criteria:

* Treatment with systemic cancer therapy within 21 days before screening.
* Major surgery within 4 weeks or minor surgery within 2 weeks of the start of study drug.
* Grade 3 sensory neuropathy or motor neuropathy with pain
* Concurrent severe or uncontrolled medical disease.
* Active systemic fungal, bacterial, and/or viral infection.
* Difficulty with swallowing, or an active malabsorption syndrome.
* Gastrointestinal diseases including Crohn's disease or hemorrhagic coloproctitis.
* History of gastric or small bowel surgery.
* Pregnant or nursing females.
Autologous Immune Killer Cells to Treat Liver Cancer Patients as an Adjunct Therapy

The purpose of this study is to evaluate the efficacy of ex vivo expanded autologous immune killer cells in treating hepatocellular carcinoma patients in：

1. Reduction of tumor size
2. Reducing the relapse rate: Reducing the frequency of TACE treatment by IKC injections.

This is a phase II/III clinical study. Blood is drawn from the patient and brought to our laboratory for isolation of immune cells. These immune cells are then proliferated over a two week period and used to produce the patented product IKC (Immune Killer Cells). The IKC will then infused back into the patient to treat the cancer. Each patient will receive a total of twelve infusions.

60 patients are anticipated to be recruited. This is a double-arm study, the experimental group will receive IKC treatment along with TACE treatment. The control group will receive only TACE treatment. 30 patients will be randomized into each arm.

Eligibility Criteria:
Inclusion Criteria:

1. Sign and give written informed consent.
2. Age≧20 years, but\<80 years.
3. Hepatocellular carcinoma by CT, MRI, AFP, angiography or cytology/biopsy examinations.
4. Barcelona staging system stage B and C.
5. Never receive TACE treatment and comply with the standard of TACE treatment.
6. Child-Pugh stage A and B.
7. ECOG performance status 0 to 2.

Exclusion Criteria:

1. Participant of other clinical trial within the past 4 weeks of screening period.
2. Receiver of chemotherapy, radiotherapy, immunotherapy, hormone therapy, local tumor therapy, or target therapy within the past 4 weeks of screening period.
3. Carriers of HIV or HTLV within the past 4 weeks of screening period.
4. With Active acute or chronic infection by (investigator's judgement).
5. Other diseases, except hepatocellular carcinoma, which are life-threatening to the patients (by investigator's judgement) for example:

   5.1 Active cardiac disease requiring therapy for coronary artery disease, congestive heart failure, arrhythmia or myocardial infarction.

   5.2 With previous history of encephalopathy within the past six months.

   5.3 Involved Involving systemically or known central nerve system diseases(brain or meningeal metastasis).
6. Women of pregnant or breast-feeding or child-bearing potential but without adequate contraception.
Intraoperative Tissue Identification by Analyzing Surgical Smoke

SurgiNose is a single-center, non-randomized feasibility study aiming to evaluate the feasibility of intraoperative tissue analysis using differential mobility of surgical smoke generated with electrocautery.

Patients receive standard-of-care breast conserving surgery.

The increasing number of breast cancer survivors and their longevity has emphasized the importance of aesthetic and functional outcomes of cancer surgery and increased pressure for the surgical treatment to achieve negative margins with minimal removal of healthy tissue.

Surgical smoke has been successfully utilized in tissue identification in laboratory conditions by using a system based on differential mobility spectrometry (DMS) that could provide a seamless margin assessment method.

In this study, a DMS-based tissue smoke analysis system will be used intraoperatively in 20 breast cancer surgeries to assess its feasibility in tissue identification. The effect of the system on complications and duration of surgeries is also studied. The surgeries are recorded with a head-worn camera system for visual annotation of the operated tissue types to enable classification of the measurement files by supervised learning.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary malignancy of the breast

Exclusion Criteria:

-
INcreasing Adolescent Social and Community SupporT - Pilot

Background: Social prescribing is a mechanism of connecting patients with non-medical forms of support within the community and has been shown to improve loneliness. Yet uptake from young people has been lower than for adults. This is thought to be due to accessibility issues as young people are less likely to draw on primary care, where social prescribing in based, for wellbeing support. INACT will pilot a social prescribing pathway via schools to support young people who are lonely. It will test the feasibility and acceptability of delivering and evaluating it through a randomised controlled trial.

Methods: 78 pupils reporting loneliness will be recruited across 12 mainstream (6 primary and 6 secondary) schools in England and be randomly allocated to signposting or social prescribing. Pupils in the control group will receive signposting to sources of support from school staff. The co-produced social prescribing intervention includes up to 6 sessions with a Link Worker who will work with individuals to understand 'what matters to them' and connect them with local sources of support. Data will be collected at baseline, 3- and 6-months later. Acceptability and feasibility will be assessed via recruitment and retention, as well as via qualitative interviews. Interviews will also explore barriers, facilitators and mechanisms of change. Potential primary and secondary outcomes for a future trial will be completed to assess response and completeness, including measures of loneliness, mental health and wellbeing.

Discussion: INACT will provide preliminary evidence of the feasibility and acceptability of both the research design and social prescribing intervention. Results will inform a potential future randomised trial.


Eligibility Criteria:
Inclusion Criteria:

* Children and young people in a participating school and in Years 4, 5 or 7, 8
* Parental consent and young person assent is provided
* A score of 6 or above on the Good Childhood Index loneliness questions

Exclusion Criteria:

* Private schools
* Children and young people with severe learning disabilities
Modifiers of Tenofovir in the Female Genital Tract

Two-armed, single visit, pharmacokinetic study to compare tenofovir diphosphate concentrations in cervical tissues of women on Depo-Provera contraception vs non-hormonal contraception.


Eligibility Criteria:
Inclusion Criteria:

* Female, or transgender female with a cervix, aged 18-35 years old
* HIV-positive
* Stable on antiretroviral regimen containing TDF for at least 2 weeks at time of enrollment.
* Virally suppressed (HIV-RNA copies \<50 copies/mL) for at least 6 months at time of enrollment.
* Willing to refrain from vaginal intercourse and use of vaginal devices such as douches and sex toys within 72 hours of the biopsy visit.
* Willing and able to give signed informed consent.

Exclusion Criteria:

* Currently pregnant or previous pregnancy within 3 months of enrollment
* Currently breast feeding
* Symptomatic vaginal infection within 2 weeks prior to enrollment
* Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynecologic surgery within 90 days prior to enrollment
* History of vulvar/vaginal/ cervical dysplasia, neoplasia or cancer, atypical squamous cells of undetermined significance, condyloma, or human papilloma virus (HPV) in the past year
* Use of oral and/or vaginal preparations of antibiotic or antifungal medications within 30 days prior to the enrollment visit
Study of the Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer

This is a Phase 2 study being conducted at multiple centers in the United States. Patients having thyroid cancer that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have disease that was not controlled by previous treatment with radioactive iodine (131I) or not be good candidates for such treatment. The purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective treatment for metastatic thyroid cancer as shown by the number of patients in the study who experience significant and durable tumor shrinkage.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented thyroid cancer with metastases.
* Failure of radioactive iodine (131I) to control the disease or radioactive iodine (131I) is not an appropriate therapy (e.g. due to lack of iodine uptake by the tumor)

Exclusion Criteria:

* Central lung lesions involving major blood vessels (arteries or veins).(Central lesions that maintain the structural integrity of vessels have the potential to bleed if the tumor lesion undergoes necrosis. MRI or CT angiography should be used in any case where there is any question as to whether blood vessels are involved.)
* Patients with a history of hemoptysis
The Effect of Negatively Fluid Balancing Speed for ICU Patients With Acute Respiratory Distress Syndrome

Previous studies have shown that a positive fluid balance was an independent factor of worse prognosis in ICU patients with acute respiratory distress syndrome (ARDS), and negative fluid balance has been demonstrated to increase oxygenation index, reduce time under mechanical ventilation and ICU length of stay with no noticeable adverse effects. But there is no evidence that faster speed of negative fluid balance would be more beneficial for ARDS patients. So researchers designed the study to prove the effect of negatively fluid balancing speed for ICU patients with ARDS.


Eligibility Criteria:
Inclusion Criteria:

·Patients with ARDS (Berlin 2012 criterion）

Exclusion Criteria:

* Pregnant women
* Unstable hemodynamics status
* \< 18 years old
Using BETTER Model Sexual Problems in Breast Cancer

Breast cancer and its treatments such as mastectomy, chemotherapy, radiotherapy, hormonal therapy cause many side effects such as scar, problems with body perception and sexual problems. Sexual concerns lead to significant emotional distress, including sadness/depression, issues related to personal appearance, stigma, and negative impacts on personal relationships, intimacy and sexuality all of which reduce the quality of life. This experimental type of research is conducted within the framework of the BETTER model to evaluate the impact of counselling programme on sexuality issues that patients with breast cancer experience.

Methods: The sampling consists of 60 female participants who volunteered to participate in the study. Face to face interviews are held with the female participants based on the Information Forms and Female Sexual Function Index (FSFI)", "EORTC QLQ-BR23 Quality of Life Questionnaire", "Center for Epidemiologic Studies Depression Scale (CES-D)", "Body Cathexis Scale (BCS)" and "BETTER Model". Counselling programme of the women in the intervention group is held in four sessions one week apart and these women are provided with a counselling booklet accompanied by a CD. The scales are re-applied one month after the last session. In the control group, the women are left under routine hospital control after the scales are applied. The scales are re-applied to the control group after one month.

Eligibility Criteria:
Inclusion Criteria:

* who have had primary diagnosis of breast cancer and are at stage 0-I-II,
* who underwent mastectomy,
* who are in full remission, receiving no other treatment except hormonal therapy,
* who has been receiving hormonal treatment for at least two months and less than 5 years,
* age limit is set range from 18 to 45
* who are literate and sexually active,
* whose spouses had no sexual health problems,
* who don't have psychiatric illness
* who are capable of verbal communication and willing to participate in the study

Exclusion Criteria:

* who have had other cancer types or at stage III-IV
* who underwent conservative breast surgery
* who receive other treatment such as chemotherapy, radiotherapy
* above 45 years old
* who did not have sexual intercourse within the last month
* whose spouses have sexual health problems
* who have psychiatric illness
* who are not willing to participate in the study
* whose contact information could not be accessed
Project PEER: Understanding the Lung Cancer Patient ExperiEnce in the Real-World Setting

LUNGevity Foundation, a non-profit lung cancer organization, wants to learn about living with lung cancer from the point of view of people with lung cancer and their family and friends who provide care. To do this, we have an online study designed to better understand how treatments people living with lung cancer receive impact their quality of life. Participants will complete surveys once a month for 12 months.

What does participation involve?

1. Emailing the study team to learn more and get access to the study website.
2. Once a month for 12 months you will receive a survey by email.
3. Complete these surveys on a smartphone, tablet, or computer at your convenience and receive an e-gift card for your time.

PEER is an international study, that is Institutional Review Board (IRB) approved and General Data Protection Regulation (GDPR) compliant.

The study objective is to collect longitudinal data to facilitate a rigorous understanding of the diagnostic and treatment experiences of people diagnosed with lung cancer and to identify determinants of treatment heterogeneity. Study data will be used to understand the diagnostic and treatment pathways, explore patient-experience data in different domains (financial impact/quality of life/symptoms) and test the hypothesis that different classes of therapies (chemotherapy/ immunotherapy/ targeted therapy/ surgery/ radiation) impact patient experience (eg., physical function).

Study participants will consent and register for the study and complete an initial baseline survey. They will then be followed for 12 months and receive a monthly survey (11 surveys in total) via email. The development of the surveys was guided by input from patients, clinicians, FDA experts, and incorporates questions from existing patient-reported outcomes (PRO) measures.

Summarized study results will also be posted on LUNGevity's website. External researchers will be able to apply to have limited access to de-identified data.

Eligibility Criteria:
Inclusion Criteria:

* Adults with self-reported lung cancer diagnosis or caregiver of someone with a self-reported lung cancer diagnosis (patient has to be alive)
* Ability to read and answer questions in English
* Access and ability to use a computer or other internet-connected device

Exclusion Criteria:

* Younger than 18
* Healthcare providers and healthcare professionals who provide care to lung cancer patients except for those who are themselves a patient or a caregiver to a loved one.
* Not able to provide informed consent
Russian Clinical Trial of Mesenchymal Cells in Patients With Septic Shock and Severe Neutropenia

Septic shock remains a significant clinical problem associated with high rates of mortality among neutropenic patient despite antimicrobial therapy and supportive care. Recently, mesenchymal stromal cells (MSC) have demonstrated remarkable potential effect in sepsis. MSC treatment significantly reduced mortality in septic mice receiving appropriate antimicrobial therapy. MSCs reduced systemic inflammatory cytokine levels in mice, down-regulated of inflammation and inflammation-related genes (such as interleukin-10, interleukin-6). Bacterial clearance was greater in MSC-treated mice. Thus, MSCs have beneficial effects on experimental sepsis and suggest that MSСs-therapy may be an effective adjunctive treatment to reduce sepsis-related mortality.

The safety of MSCs is proved by Graft-versus-host disease treatment MSCs in patients after bone marrow transplantation.

This study hypothesis is that MSCs reduce organ dysfunction/injury, systemic inflammation and mortality in patients with septic shock and severe neutropenia.

The main goal of the study is to evaluate the impact of MSCs therapy on organ dysfunction/injury, systemic inflammation and 28-day mortality in patients with septic shock and severe neutropenia. All patients will be randomized in two groups: control group (standard treatment of septic shock) and MSCs-group (standard treatment of septic shock + MSCs infusion of 1-2 millions/kg/ day).

All activities related to this human subjects research have been guided by ethical principles and have been reviewed and approved Federalwide Assurance National Ctr for Hematology, FWA00006482. The goal of the trial is to evaluate plasma concentration of proinflammatory cytokine interleukin-6 and the antiinflammatory cytokine interleukin-10, plasma levels of blood creatinine, bilirubin, procalcitonin, C-reactive protein. Then we will evaluate requirement for renal replacement therapy, requirement for mechanical ventilation or non-invasive mechanical ventilation, pulmonary function-coefficient, partial oxygen pressure arterial blood level, electrocardiograms, Kaplan - Meier curve,28-days mortality.

Eligibility Criteria:
Inclusion Criteria:

septic shock

≤10 hs after onset of septic shock severe neutropenia(≤ 1 10\^9/l) Patients ≥17 years Signed Informed Consent to treatment

Exclusion Criteria:

oncohematological patients with resistance to chemotherapy Unsigned Informed Consent to treatment Age \>75 years; Pregnancy