cyrilzakka/clinical-trials huggingface dataset:
Crossover Post-herpetic Neuralgia (PHN)

The purpose of the study is to evaluate the efficacy of study drug (BMS-954561) as compared to placebo in the treatment of patients with post-herpetic neuralgia (PHN).

Allocation: Randomized Stratified

Interventional model: Cross-over Placebo Controlled

Eligibility Criteria:
Inclusion Criteria:

* Patient with Post-Herpetic Neuralgia (PHN) as defined as pain present for more than 6 months after the onset of a herpes zoster skin rash affecting the trigeminal, cervical, thoracic, lumbar, or sacral regions.
* Based on patient diary information collected during the Baseline week (day -7 to randomization Day 1), patient has completed at least 5 diary entries and has an average weekly pain rating of at least 4 on the 11-point pain rating scale.
* The patient is able to satisfactorily complete, in the Investigator's judgment, the Cognitive Battery.
* Male or female, 18-85 years of age.

Exclusion Criteria:

* Other severe pain that may potentially confound pain assessment.
* History of complete lack of response to pregabalin (at least 300 mg qd for 4 weeks) or gabapentin (at least 1800 mg qd for 4 weeks).
* Hemoglobin A1c \> 9%
* Hemoglobin ≤ 9 g/dL.
* Active herpes zoster or known viral infection.
* Previous neurolytic or neurosurgical therapy for PHN.
* Estimated glomerular filtration rate (eGFR) according to the re-expressed abbreviated (four-variable) Modification of Diet in Renal Disease (MDRD) Study equation ≤ 40ml/min/1.73m2.
* Patients who have been on a stable dose of anticonvulsant,anticholinergic, antiviral medications, nicotine replacements, or any other smoking cessation medications for \<4 weeks prior to randomization. Patients who are on stable doses for =\> 4 weeks prior to randomization are allowed, however, there should be no adjustments to the dose of these medications during study.
* Patients currently on more than one drug for treatment of neuropathic pain (low dose opioids, antidepressants, or anticonvulsants). Patients are allowed to participate if on a stable dose for at least 4 weeks prior to randomization (Day1) and should remain stable during course of study.
Long-Term Retention of Gadolinium in Bone

The main objective was to prospectively explore the potential for long-term retention of Gadolinium (Gd) in bones in patients who have received a single dose of Gadolinium-based contrast agents (GBCA) or multiple doses of the same GBCA, with moderate or severe renal impairment or stable normal renal function (eGFR \> 60 ml/min/1.73 m2) at the time of GBCA injection.

In order to collect additional clinical data this study was requested by the European Medicines Agency to further investigate whether Gd in human bone and skin are detectable for a long time after administration of GBCAs in patients with impaired renal function who had previously received any of the six different contrast agents (Gadobutrol, Gadodiamide, Gadopentetic acid, Gadoteric acid, Gadoversetamide, and Gadoxetic acid) within a magnetic resonance contrast imaging procedure and who are scheduled for an orthopaedic surgical procedure.

For this study the patients have not been administered any GBCA.

Participating sites are located in Germany, Italy, Poland, Spain, Turkey, USA, Japan, India and Republic of Korea.

Eligibility Criteria:
Main Inclusion Criteria:

* Patient scheduled for an orthopaedic surgical procedure
* A minimum of 1 month has elapsed between GBCA dose and scheduled orthopaedic surgical procedure
* Patient belongs to one of the following subgroups with respect to the number of GBCA doses received and the status of their renal function:

  1. patient has stable impaired renal function (at least moderate impairment, eGFR ≤ 60 ml/min/1.73 m2) and has received one GBCA injection at the standard dose (0.025 mmol per kg body weight for Gadoxetic acid and 0.1 mmol per kg body weight for all other agents) or
  2. patient has stable impaired renal function (at least moderate impairment, eGFR ≤ 60 ml/min/1.73 m2) and has received more than one injection of the same GBCA or
  3. patient has stable normal renal function (eGFR \> 60 ml/min /1.73 m2) and has received one GBCA injection at the standard dose (0.025 mmol per kg body weight for Gadoxetic acid and 0.1 mmol per kg body weight for all other agents) or
  4. patient has stable normal renal function (eGFR \> 60 ml/min/1.73 m2) who have received more than one injection of the same GBCA

Main Exclusion Criteria:

* Patient has received different GBCAs.
* Patient has received intra-articular GBCA or per any other non-i.v. route
* Patient has received any investigational product or has participated in any other clinical trial within 30 days prior to enrolling in this study.
Treosulfan Pharmacokinetics in Children Undergoing Allogeneic HSCT

Every year around 70 children affected by cancer or life-threatening genetic diseases undergo haematopoietic cell transplantation (HCT) within the Blood and Marrow Transplant (BMT) unit at Great Ormond Street Hospital (GOSH).

One of the main goals of the BMT unit over the last decade has been to reduce the morbidity and mortality related to HCT, and the group has become a world-leader in pioneering less toxic transplants.

Fixed high doses of chemotherapy drugs are generally used to prepare children for HCT but several studies have shown a correlation between the concentration of these drugs achieved in the patient's blood, and the success or failure of the HCT procedure.

Recently a new drug, Treosulfan, has become available for use in patients undergoing HCT, and GOSH has pioneered its introduction in children undergoing HCT. With promising early results, Treosulfan has become the pre-HCT drug of choice, however, very little is currently known about how the drug is metabolised and cleared from the body, particularly in children.

The investigators therefore plan to investigate the pharmacokinetic (PK) profile of Treosulfan in children undergoing HCT at GOSH and define which parameters affect its metabolism and clearance, and what blood levels are associated with a favourable outcome (graft take without toxicity) or a poor result (graft rejection and/or toxicity).


Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 28 days and ≤ 18 years old;
2. Karnofsky Performance Status ≥ 50 or Lansky Performance Status ≥ 30;
3. provide signed, written informed consent from parent or guardian;
4. be able to comply with study procedures and follow-up examinations;
5. have adequate organ function (as indicated by Table 1, page 27), within 14 days prior enrollment;
6. negative pregnancy test in post-pubertal female patients.

Exclusion Criteria:

1. patients aged \< 28 days and \> 18 years old;
2. patients with compromised organ function\*;
3. patients with any other severe concurrent disease, which, in the judgment of the Investigator, would make the patient inappropriate for entry into this study;
4. known hypersensitivity to Treosulfan or Fludarabine;
5. pregnancy/lactation.
Home-based Massage by Caregivers for Dementia

The purpose of this study is to investigate the effects of manual massage on improving behavioral and psychological symptoms of dementia and sense of burden among caregivers.

A total of 40 patients with dementia and their family caregivers will be included and randomly allocated to experiment (n=20) or control group (n=20). The experiment and control group will receive whole body manual massage and placebo intervention (30 minutes once per week for 8 continuous weeks), respectively.

Eligibility Criteria:
Inclusion Criteria:

* Over 65 years old, diagnosed with dementia, agitation or depression, irregular massage and exercise habits.

Exclusion Criteria:

* Those who have open wounds, inflammation, infection, burns and scalds, artificial blood vessels in the hands, or diagnosed as inappropriate for massage in the near future, the severity of symptoms affects the study participants.
Study of ISM6331 in Participants With Advanced/Metastatic Malignant Mesothelioma or Other Solid Tumors

This is a Phase 1, open-label, multicenter, FIH study to evaluate the safety, tolerability, recommended Phase 2 dose (RP2D), PK/PD, and preliminary anti-tumor activity of ISM6331 in participants with advanced or metastatic malignant mesothelioma or other solid tumors. The study consists of two parts, a dose escalation part (Part 1) and a dose selection optimization part (Part 2).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants with age ≥18 years at the time of signing the informed consent.
2. Histologically confirmed unresectable advanced or metastatic malignant mesothelioma or other solid tumors, who have disease progression after standard therapy, intolerable to standard therapy, or for whom no standard therapy exists, participants for part 1 is regardless of the presence or absence of the genetic alterations of the Hippo pathway, but for part 2 participants with solid tumors other than mesothelioma, genetic testing documentation must demonstrate Hippo signaling pathway dysregulation.
3. For participants with malignant mesothelioma, prior treatment of ≥2 regimens are required, including but not limit to immune checkpoint therapy.
4. Presence of at least one evaluable lesion in Part 1 or one measurable target lesion in Part 2 according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) for participants with non-pleural mesothelioma or other solid tumors and modified RECIST (mRECIST) v1.1 for participants with malignant pleural mesothelioma.
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
6. Life expectancy of ≥12 weeks as judged by the investigator.
7. Adequate organ function as determined by medical assessment (within 7 days prior to the first dose of study treatment).
8. Capable of providing signed informed consent form (ICF) and complying with the requirements and restrictions listed in the ICF and in this study protocol.

Exclusion Criteria:

1. Participants who have previously received a TEAD inhibitor.
2. Participation in other therapeutic clinical studies within 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment.
3. Anti-tumor therapy within 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment.
4. Known active central nervous system (CNS) primary tumor or untreated CNS metastases.
5. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases.
6. Unwillingness or unable to comply with the requirements of oral drug administration, or presence of a gastro-intestinal condition
7. Have prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, laboratory abnormality or any other conditions that, in the investigator's opinion, would not be in the best interest of the participant; or that could alter the absorption, distribution, metabolism, or excretion of the study treatment; or impair the assessment of study result.

Other protocol inclusion and exclusion criteria may apply.
mHealth-supported Telecolposcopy for Cervical Cancer Programs in Low-resource Settings: Evaluation (mIVAA)

The central hypothesis is that use of mIVAA (mobile Inspección Visual con Ácido Acético - Spanish for Visual Inspection with Acetic Acid (VIA)) will increase the proportion of VIA positive women who complete follow-up clinical evaluation compared to VIA positive women in situations in which mIVAA was not used, thus potentially improving cervical cancer treatment and survival rates. The study will collect qualitative and quantitative data to examine the feasibility and preliminary impact of mIVAA on reducing attrition for follow-up clinical evaluations.

The study will be conducted in Lima, Peru in the context of mobile units operated by La Liga for promoting cancer screening. mIVAA comprises two components: a digital imaging device and a telemedicine platform.

1. The digital imaging device is either a mobile phone camera or the pocket colposcope plugged into a mobile phone.
2. The telemedicine platform is mobile phone-based, with an interface for midwives in the mobile units to enter patient information and acquire and upload cervical images, and an interface for the colposcopists based remotely to review the cervical images and patient information and return feedback.

The specific aim is to pilot test mIVAA in a community-based setting in Peru.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Patients coming to the mobile unit for cervical cancer screening
* Willing to allow use of mIVAA during screening with VIA.
* Agree to be audio recorded

Exclusion Criteria:

* Currently pregnant
* History of hysterectomy
* Does not understand the study purpose and details
* Is not willing to sign an informed consent
Identification Predictive Markers of Immunochemotherapy Response to the Primary Cutaneous Diffuse Large B Cell Lymphoma

The study is performed on a single-center retrospective cohort of 32 patients LBC-TJ treated with R-chemotherapy for which data collection was carried out in homogeneous and prospectively followed according to international standards through RCP monthly cutaneous lymphomas managed by Professor Beylot-Barry and inclusion of cases in the national database of rare cancer network French Study Group of Cutaneous Lymphomas in Bordeaux managed by Prof. Beatrice Vergier. Fourteen patients responded to the R-PCT against 18 non-responders, 14 patients for whom we have the sample to recidivism.

The objective is to identify predictive biomarkers of response to R-chemotherapy and understand what genomic markers, transcriptomic or proteomic would identify those patients ahead. This would ultimately help to identify whether dysregulated biological pathway could be targeted specifically among patients with personalized treatment.

Like its counterpart systemic Lymphoma Diffuse large B cell, the sequential analysis of the same patient at diagnosis and relapse can also identify candidate genes and biological pathways involved in recurrence and help to design new therapeutic strategies.

Another objective is ultimately the development of an integrative bioinformatics tool for anticipating the therapeutic response. The tumor model used is certainly a rare cancer but prototypical ABC lymphomas allowing access to relapse hardware and relative homogeneity that will allow a study of a smaller number of cases for the development of correlations models genomics / proteomics. This is a pivotal project integrating proteomic data and Molecular Biology (mutation, expression) based on the pooling of skills of clinical teams, biological and bioinformatics to validate a predictive model for treatment response able to integrate prognostic markers known as TNM the dual expression MYC / BCL2 and forward to predict the therapeutic response using this modeling by CBIB. We would then validate the model established in this series of training on a range of national validation as part of an observational study with GFELC (Groupe Français d'Etude des Lymphomes Cutanés).

Eligibility Criteria:
* Patients LBC-TJ
* Treated with R-chemotherapy
Smart-phone Application Versus Conventional Paper for the Documentation of Voiding Dysfunction in Children

The objective of the research is to compare the written voiding diary method to the smart-phone diary, DryDawn®, which the investigators selected among several applications using specific criteria appropriate to our population. The investigators aim is to describe the method that proves to be most efficient by assessing which diary provides the best quality and amount of information, and draws the highest level of satisfaction from participants.

Patient satisfaction will be assessed using a questionnaire that was designed for use in this study.

The idea of using smart-phone applications for the purpose of medical management is not new, however, results from studies have been variable and few have characterized their use in the management of disease in children. The propose of study is to conduct a a research that involves the use of a smart-phone voiding diary application in children.

The intention of this research is to identify which method of documentation, either a smart-phone voiding diary application or the conventional written diary, is most effective in gathering information from urology patients in the pediatric population.

The investigators will conduct a prospective randomized study to investigate which type of diary is better regarding data collection and patient's satisfaction. Consenting individuals will be informed of the study details and their safety will be assured. Patients/parents will be informed of their right to withdraw from the study at any moment.

The two groups refer to the two methods of documentation (diaries) to which will be randomly assigned .The diaries are the smart-phone diary application, DryDawn ® (The Arabic version), or the conventional pen-and-paper method.

A website (www.randomizer.org) will be used to generate a randomized numbered lists that determine participant allocation to one of two study groups.

Data collection will include patient demographics, the type of diary used, as well as the information that participants provide in either of the voiding the diaries and the satisfaction questionnaire. The investigators will analyze the data and report on the percentage of participants who complied with their diary completion, information provided by patients and caregivers in the diary, and the number of participants in the study. Moreover, a questionnaire (Voiding diary Satisfaction Questionnaire) will be given to each family evaluating the patient/caregiver satisfaction.

If the diary has to be repeated, automatically will switch to the other type of diary. A re-evaluation of the diary satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* New patients who have a voiding dysfunction that necessitates the use of a voiding diary
* Children ages six (6) to eighteen (18) years
* Participants must own a smart-phone

Exclusion Criteria:

* Children less than six (6) years of age
* Participants who do not own a smart-phone
Safety and Clinical Activity of ThisCART22 in Patients With r/r Non-Hodgkin's B Cell Lymphoma

A single arm, open-label, dose-escalation study to evaluate the safety and clinical activity of ThisCART22 (Allogeneic CAR-T targeting CD22) in patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).

ThisCART22 cell is a non-gene-editing allogeneic CAR-T cell targeting CD22. This study is designed to evaluate the safety and clinical activity of ThisCART22 in patients with CD22 positive, relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years old, no gender and race limited;
2. Estimated life expectancy \> 12 weeks deemed by investigator；
3. CD22 were positive by histopathology and/or cytology diagnosis；
4. Patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL)；
5. Relevant indicators for disease or assessment within 4 weeks after the last treatment;
6. Quality of Life Score (KPS) \>50%；
7. Subject has adequate organ function at screening, cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO); serum ALT/ AST \<3 upper limit of normal (ULN); bilirubin\<2.0 mg/dl; serum creatinine ≤1.6 mg/dl and/or BUN ≤ 1.5 mg/dl;
8. No remission or relapse after hematopoietic stem cell transplantation or autologous somatic immunotherapy;
9. Unsuitable conditions for stem cell transplantation;
10. Signed informed consent form (ICF).

Exclusion Criteria:

1. Women in pregnancy or lactation;
2. In active infection including hepatitis B, hepatitis C, HIV, or other fatal viral and bacterial infection；
3. The absolute count of nonprimary neutrophil \< 0.75×10\^9/L or platelet count \< 50×10\^9/L;
4. Abnormal vital signs and failure to cooperate with examination;
5. Patients with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation;
6. Highly allergic constitution or history of severe allergy;
7. Patients with systemic infection or severe local infection requiring anti-infection treatment;
8. Patients with severe autoimmune diseases;
9. Presence of any other conditions that are unsuitable for this study as judged by the investigator.
Sirolimus in Kidney Transplant Patients With Squamous Cell Skin Carcinoma

Solid organ transplant recipients (SOTR) have a 3-5x increased occurrence of cancer in contrast to the general population with basal and squamous cell skin cancer. The use of immunosuppressant or anti-rejection drugs that are needed after SOTR is known to increase the risk of developing certain kinds of cancer. The purpose of this study is to find out how well Sirolimus (also known as Rapamune) works at treating squamous cell carcinoma in renal transplant patients.

This is a Phase II randomized study to evaluate the effectiveness of Sirolimus in treating and preventing squamous cell skin cancer carcinoma using a Simon's 2-stage design. As part of the study, after the biopsy results of the skin cancer show squamous cell carcinoma and consent had been obtain, the participant will begin taking Sirolimus. The calcineurin inhibitor (tacrolimus or cyclosporine) will be discontinued once the transplant doctors find that the participants Sirolimus is therapeutic by checking blood tests once a week x 3 weeks. Approximately 5 weeks after starting Sirolimus, the squamous cell skin cancer will be removed by a surgeon. Participant next follow up visit for the study is scheduled one year post-operatively. .The study will look at your squamous cell skin cancer under the microscope to see if sirolimus had any effect at treating your squamous cell skin cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven squamous cell skin carcinoma
* Recipient of a renal organ transplant at least one year prior to study enrollment
* Receiving a CNI for at least 6 months prior to diagnosis of skin cancer
* No current evidence of graft rejection, except low-grade, chronic graft rejection
* Measurable disease by caliper measurement
* Life expectancy \> 6 months
* Age of at least 18 years
* Adequate organ and marrow function as determined by ANC, HGB, PLT, Total Bili, AST, and creatinine clearance
* Ability to understand/willingness to sign a written informed consent form

Exclusion Criteria:

* Inability to give informed consent
* Major surgery within 4 week prior to starting study drug
* Chronic or non-healing open wounds
* Pregnant and nursing women
* Women and men of child-bearing potential must agree to use adequate contraception prior to study entry and for the study duration
* Prior use of an mTOR inhibitor
* Pre-existing clinically significant cardiac, hepatic, pulmonary, or renal dysfunction
* HIV-positive patients
* Proteinuria (\> 1 gram)
* Prior or current history of uncontrolled hyperlipidemia (cholesterol \> 302 mg/dl or triglycerides 354 mg/dl
* Currently receiving any investigational agents
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to sirolimus (mTOR inhibitors)
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrythmia, or psychiatric illness/social situations that would limit compliance with study requirements