cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma

To evaluate the efficacy and safety of TQB3702 tablets combined with immunochemotherapy for the treatment of B-cell lymphoma


Eligibility Criteria:
Inclusion Criteria:

* The subjects voluntarily joined the study, signed the informed consent, and the compliance was good;
* Age: 18 years old ≤ age (when signing the informed consent) ≤75 years old; Eastern cooperative oncology group (ECOG) score: 0-2; Expected survival of more than 3 months;
* Histologically confirmed B-cell lymphomas of the following types that meet the 2022 World Health Organization (WHO) diagnostic criteria:

  1. Relapsed/refractory indolent B-cell lymphoma
  2. Diffuse large B cell lymphoma（DLBCL）
* Previous treatment: Relapsed/refractory inert B-cell lymphoma: have received at least one previous line of systemic standard therapy
* Have at least one measurable lesion.
* The main organs function well.
* Female subjects of reproductive age should agree to use contraception (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male subjects should agree to use avoidance during the study period and for 6 months after the end of the study period.

Exclusion Criteria:

* Have had or are currently suffering from other malignant tumors within 3 years prior to the first medication.
* Known or suspected central nervous system (CNS) aggression.
* Relapsed/refractory inert B-cell lymphoma: previous allogeneic hematopoietic stem cell transplantation, or autologous hematopoietic stem cell transplantation within 3 months before the first treatment;
* Recurrent/refractory indolent B-cell lymphoma: toxic reactions that do not return to ≤ National Cancer Institute standard for common toxic reactions (NCI-CTC) AE Grade 1 due to any previous treatment, excluding hair loss and fatigue;
* Have multiple factors that affect oral drug absorption (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
* Received major surgical treatment or significant traumatic injury within 28 days before the start of study treatment;
* Hyperkinetic/venous thrombosis events occurred within 6 months before the first medication;
* Have a history of psychotropic drug abuse and can not quit or have mental disorders;
* Subjects with any severe and/or uncontrolled disease;
* Received live vaccine or messenger ribonucleic acid (mRNA) vaccine within 4 weeks before the first dose, or planned to receive live vaccine or mRNA vaccine during the study;
* Participated in clinical trials of other antitumor drugs within 4 weeks before the first medication;
* Subjects who, in the judgment of the investigator, have concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are not suitable for enrollment for other reasons.
A Study to Evaluate the Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia (MK-1167-008)

Researchers want to learn if giving MK-1167 (the study medicine) along with acetylcholinesterase inhibitor (AChEI) therapy can improve symptoms of Alzheimer's disease dementia (AD dementia), such as memory and mental activity. AD dementia is the most common type of dementia. AChEI therapy is the standard treatment for AD dementia.

The goals of this study are to learn:

* If at least one dose level (amount) of MK-1167 works to improve a person's memory and thinking compared to a placebo
* About the safety of MK-1167 and if people tolerate it


Eligibility Criteria:
Inclusion Criteria:

* Has mild to moderate Alzheimer's Disease (AD) dementia (ie, Stage 4 or Stage 5 AD) based on the Alzheimer's Association Revised Criteria for Diagnosis and Staging of Alzheimer's Disease
* Has a Mini-Mental State Examination (MMSE) score of 12 to 24 (inclusive)
* Is using acetylcholinesterase inhibitors (AChEI) therapy for management of AD dementia
* Has a designated study partner who can fulfill the requirements of this study. The study partner will need to spend sufficient time with the participant to be familiar with their overall function and behavior and be able to provide adequate information about the participant needed for the study including, knowledge of functional and basic activities of daily life, work/educational history, cognitive performance, emotional/psychological state, and general health status

Exclusion Criteria:

* Has a known history of stroke or cerebrovascular disease
* Has diagnosis of a clinically relevant central nervous system (CNS) disease other than AD dementia or other condition that negatively impacts cognition or cognitive status chronically
* Has structural brain disease
* Has a history of seizures or epilepsy
* Has any other major CNS trauma, or infections that affect brain function (eg, Human immunodeficiency virus (HIV), syphilis, and/or neurological sequelae of Coronavirus disease caused by severe acute respiratory syndrome coronavirus 2 (COVID-19), including impact on cognition)
* Has major medical illness or unstable medical condition
* Has a history of malignancy
* Resides in a nursing home or assisted care facility with need for direct continuous medical care and nursing supervision (with protocol-specified exceptions)
* Has liver disease, including but not limited to chronic viral hepatitis, nonviral hepatitis, cirrhosis, malignancies, autoimmune liver diseases
Exploring Individual Nutrition Care Elements and Nutritional Evaluation Methods Within Dietetic Practice in Cancer Care

The purpose of the study is to explore and deepen the understanding of the dietitian's role and work related to individually tailored nutritional treatment in cancer care. The research questions focus on behavior change strategies, goal setting, the possibility of using calf circumference to assess changes in muscle mass, and mapping energy and protein intake, nutritional symptoms, and food-related quality of life during nutritional treatment for cancer patients.

In the first part of the project, audio recordings of conversations between dietitians and patients with cancer will be conducted to investigate the dietitian's work with behavior change strategies and goal setting. Data analysis will be performed using two different methods: content analysis and thematic analysis. The research subjects include both dietitians and cancer patients who engage in conversations.

The second part of the project will include 100 patients with cancer at risk for or with malnutrition. Data collection will involve measurements of weight, height, calf circumference, muscle mass, energy and protein intake, nutritional symptoms, and food-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for the first part of the project involve encountering dietitians treating patients with cancer who have malnutrition or are at risk of malnutrition. For these patients, the inclusion criteria are as follows:

* aged ≥18 years with a diagnosed cancer
* ongoing nutrition therapy by a dietitian
* malnutrition or risk of malnutrition according to the hospitals criteria where at least one of the following criteria must be met: low BMI, involuntary weight loss, and/or eating difficulties. Patients can also be included if they are referred to a dietitian based on treatment guidelines due to a high risk of malnutrition associated with the cancer diagnosis or its medical therapy.

For the second part of the project, the inclusion criteria are:

* aged ≥18 years with a diagnosed cancer
* undergoing or planned treatment, including surgical, oncological, or a combination of these
* have been referred to a dietitian but have not yet had their initial contact with the dietitian, and
* malnutrition or risk of malnutrition according to the hospital's criteria, where at least one of the following criteria must be met: low BMI, involuntary weight loss, and/or eating difficulties. Patients can also be included if they are referred to a dietitian based on treatment guidelines due to a high risk of malnutrition associated with the cancer diagnosis or its medical therapy.

Exclusion Criteria:

For the first part of the project, the exclusion criteria regarding patients are:

* known dementia or impaired cognitive function, and
* not proficient in spoken and written Swedish.

For the second part of the project, the exclusion criteria are:

* known dementia or impaired cognitive function,
* ongoing nutrition therapy by a dietitian at inclusion, and
* not proficient in spoken and written Swedish.
Fate at Long-term of Mild to Moderate Bicuspid Aortic Valve Disease Left Untreated at the Time of Supracoronary Ascending Aorta Replacement

Aortic valve bicuspid disease is the most common congenital heart disease. It affects 0.5-2% of the population and is associated with an increased risk of developing aortic or ascending aortic valve complications.

There is no agreement regarding the opportunity for a "prophylactic" simultaneous aortic valve replacement in the case of mild or moderate aortic valve disease in the bicuspid valve, in patients with an indication for replacement of the ascending aorta due to an aneurysm involving its supra-coronary tract.

The aim of this study is to evaluate the long-term evolution of mild and moderate aortic valve disease in untreated bicuspid valve during supracoronary ascending aortic replacement surgery at our institution.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients;
* Bicuspid aortic valve;
* Presence of ascending aortic aneurysm in the supra-coronary tract treated with replacement using a prosthetic tube between 2002 and January 2020;
* Untreated aortic valve disease of no more than moderate degree (\<2+) at the time of ascending aorta surgery.

Exclusion Criteria:

* Emergency/urgency procedures;
* Presence of aneurysm extending to the aortic arch or aortic root, with indication for aortic root or aortic arch surgery;
* Tricuspid aortic valve tricuspid;
* Absence of aortic valve disease;
* Presence of moderate-severe or severe aortic valve disease, with indication to a concomitant aortic valve replacement.
Long-term Study of Endoscopic Treatment of Stenosis in Crohn´s Disease

Stenosis is one of the most frequent complications in patients with Crohn's disease (CD), causing greater morbidity and increasing the probability of repeated surgery and short bowel syndrome. Several endoscopic techniques, as an alternative to surgery, have been used in the treatment of fibrostenotic CD, with similar efficacy and lower risk of complications.

The ProtDilat study (NCT02395354) showed that both endoscopic balloon dilation (EBD) and self-expandable metal stents (SEMS) are efficient and safe for the treatment of stenosis in CD, while EBD shows therapeutic superiority (80.5 vs 51.3 %) at one year follow-up. However, this difference was not observed in the subanalysis of patients with stenosis \> 3 cm (EBD: 66.7% vs SEMS: 63.6%) but with a lower cost for EBD (EDB 1,365.63 euros versus SEMS 1,923.55 euros).

Therefore, SEMS could be a suitable treatment option for longer stenoses in which EBD has proven to be less efficacious. Moreover, the long-term efficacy of both endoscopic treatments is still debated with scare information and without data from a clinical trial.

The aim of this study is to assess the long-term efficacy of EBD and SEMS, through the follow-up of the patients included in the ProtDilat study, being the primary objective of the study the percentage of patients free of surgical intervention at the end of follow-up. Retrospective study based on data from the ProtDilat trial (patients with CD, obstructive symptoms, with stenosis \< 10cm). Data on medical, endoscopic and surgical treatment and smoking habits are collected.


Eligibility Criteria:
Inclusion Criteria:

* Age18-75.
* CD with predominating de novo and/or anastomotic fibrotic stenosis confirmed by endoscopy and radiology and accessible by endoscopy (colonoscopy).
* Stenosis previously treated with a stent and/or dilatation and with at least one year asymptomatic.
* Intestinal occlusion or sub-occlusion symptomatology.
* Refractoriness to conventional medical treatment (no response to accelerated step-up of normal therapeutic scale).
* Stenosis length \< 10 cm.
* Maximum 2 stenoses.
* Informed consent of patient.

Exclusion Criteria:

* No informed consent of patient.
* Stenosis complicated by abscess, fistula, or important activity associated with CD not limited to the stenosis area.
* Stenosis previously treated with a stent and/or dilatation and with less than one year asymptomatic.
* Pregnancy or lactation.
* Any clinical condition that prevents the performance of endoscopy.
* Stenosis inaccessible by colonoscopy.
* No obstructive symptoms.
* Stenosis length ≥ 10 cm.
* Presenting more than 2 stenoses.
* Serious coagulation disorder (platelets \< 70000; INR \> 1.5)
Postoperative Pain After Endoscopic TEP vs. Lichtenstein Hernioplasty in Inguinal Hernia Repair

Immediate pain reaction and return to work after TEP or Lichtenstein hernia repair have not been studied. In this multicenter trial the patients are allocated to surgery using TEP (n=50) or Lichtenstein (n=50) technique. Pain and return to work are recorded postoperatively up to one month. Immediate and late complications are also analyzed.

Patient characteristics are recorded before surgery. The adult patients with inguinal hernia are randomized into endoscopic totally extraperitoneal hernioplasty (TEP) or open Lichtenstein hernioplasty. Pain reaction to surgery and return to work are asked many times using questionnaire and pain diary (pain scores from 1h to 30 days after surgery). Surgical complications and use of pain killers are carefully recorded. Clinical examination is performed if necessary.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of symptomatic inguinal hernia Age 18-80

Exclusion Criteria:

Large scrotal hernia Bilateral hernia Symptom-free hernia Inguinal pain without clinical evidence of hernia Asa class≥3
Preventative Misconception Intervention

This study will carry out a preliminary "proof of concept" to evaluate two types of supplemental information that would serve as an adjunct to the traditional informed consent in a Human Immunodeficiency Virus (HIV) vaccine clinical trial. These will be compared to the condition where the traditional informed consent form is used alone.

Using four intervention sites, participants will be administered a standard HIV vaccine trial consent form. They will then be randomized into three conditions: 1) No supplemental information; 2) Supplemental information with 1-sided messages (emphasizes information content related to vaccine trial randomization and unproven efficacy of vaccine); and 3) Supplemental information with 2-sided messages (acknowledges the beliefs that are at odds with the information content and seeks to neutralize those beliefs through counter-argument). An interviewer-administered questionnaire (IAQ) Part 1 will be administered before the traditional HIV vaccine trial informed consent is reviewed with the participant. An IAQ Part 2 will be administered directly after the HIV vaccine trial informed consent in the control condition or after reading through the supplemental material. Debriefing interviews will be conducted with selected participants to review their understanding of the study procedures and their reactions to the supplemental materials and/or questionnaires.

The proposed research is a "proof of concept" study and is therefore not designed to test hypotheses. Consequently, formal hypothesis and related power calculations to detect certain effect sizes are not required. Instead, the goal will be to enroll an appropriate number of subjects for purpose of determining the feasibility of developing a larger study of supplemental information to be used as an adjunct to the informed consent statement in HIV vaccine clinical trials and providing related descriptive statistics.


Eligibility Criteria:
Inclusion Criteria:

* Not known to be HIV positive by self report; NOTE: HIV test is not a criterion for entry. Participants will be referred for HIV testing, if interested;
* A history of at least one unprotected sexual encounter involving either vaginal or anal penetration (receptive or insertive) with a male partner during the 6 months prior to enrollment;
* Between the ages of 16-19 (inclusive) at the time of informed consent/assent;
* Ability to understand both written and spoken English;
* Willing to consider enrollment into an HIV vaccine trial; and
* Gives informed consent/assent for study participation.

Exclusion Criteria:

- Anything that would impair the participant's ability to meet the study requirements (i.e. readily apparent psychiatric symptoms (hallucinations, thought disorder), visibly distraught (suicidal, homicidal, exhibiting violent behavior), intoxicated or under the influence of alcohol or other substances at the time of study enrollment\*;

\*NOTE: Participants cannot be visibly under the influence at the time of consent/enrollment, or during interviews.
Influence of Implant Surface Decontamination on the Reconstructive Outcomes of Peri-implantitis

Two groups are aimed at being investigated in three centers (CICOM, Clinica Branemark and Clinica Joan Pi)

* Test group: Group electrolytic approach (EA): Mechanical detoxification using curettes + NiTi brushes + EA (GalvoSurge) during 2 minutes
* Control group: Group hydrogen peroxide (HP): Mechanical detoxification using curettes + NiTi brushes + hydrogen peroxide 5% for 2 minutes soaked in a gauze Patients´ group selection will be randomly allocated. For patients whom their personal clinical record # ends in a number from 0 to 4 will be included in the test group, while for patients whom their personal clinical record # ends from 5-9 will be included in the control group.

The infra-osseous component will be regenerated using xenograft (Creos, NB) + autogenous bone in a ratio 1:1 harvested from the adjacent area. A resorbable membrane (Creos, NB) will be placed to compartmentalize the infra-osseous component following a poncho-like approach.


Eligibility Criteria:
Inclusion:

* Screw-retained or cement-retained fixed or removable implant-supported prosthesis for a minimum of 36 months.
* All patients in age of 18 to 80
* non-smokers
* no presence of systemic disease or medication known to alter bone metabolism
* partial or complete edentulous patients that have no active periodontal disease.

Exclusion criteria:

* pregnancy or lactation
* history of or current smokers
* uncontrolled medical conditions,
* lacking keratinized mucosa (≤2mm) on the lingual or buccal implant sites,
* advanced(A) peri-implantitis (\>50% of the implant length).
Investigation of Critically Ill Patients With Newly Diagnosed Diabetes

The purpose of this study is to investigate the clinical outcomes and glucose control metrics of critically ill patients with previously undiagnosed diabetes compared to those with known diabetes at the time of admission to the intensive care unit (ICU).

This case control study compares previously undiagnosed diabetic patients (defined as HbA1c \> 6.5% and no history of diabetes), to those with known diabetes, using 1:1 matching. Patients met inclusion criteria by having HbA1c available on ICU admission and at least four blood glucose tests during their ICU stay. Primary outcomes included ICU length of stay and inpatient mortality. Secondary outcomes included glucose metrics: mean blood glucose, coefficient of variation and percentage of patients who developed hypoglycemia.

Eligibility Criteria:
Inclusion Criteria:20

* Patients admitted between 9/14/2011 and 11/30/19 with HbA1c available on admission and at least four documented blood glucose tests during their ICU stay.

Exclusion Criteria:

* Patients admitted for diabetic ketoacidosis.
* Patients admitted to the ICU following cardiovascular surgery.
LAMBDA 002 (Lung Registry) Study

The LAMBDA 002 registry study is an observational, longitudinal, multi-center study observing patients undergoing lung transplant.

The LAMBDA 002 registry study is an observational, longitudinal, multicenter study observing patients undergoing lung transplant in one of the following two cohorts:

Cohort 1: Previously enrolled and randomized in LAMBDA 001 (transbronchial biopsy surveillance or Prospera surveillance) and enrolled at least 12 and up to 18 months post-transplant.

Cohort 2: Not previously randomized in LAMBDA 001 (may have been enrolled but randomization did not occur), Prospera testing is part of clinical care and enrolled during less than or equal to 12 months posttransplant.

Primary Objective:

The primary objective of the study is to assess the clinical utility of combining Prospera testing with routine transplant management in detecting acute rejection or infection events in patients receiving Prospera testing as part of their post-transplant clinical care.

Secondary Objectives:

The secondary objectives of the study are to:

1. Determine whether Prospera can detect AR (acute rejection) and/or infection earlier than standard clinical indicators used concurrently during the study.
2. Evaluate Prospera's ability to differentiate between rejection and infectious injuries for single and repeat episodes of bacterial, viral, mycobacterial and fungal infections.
3. Evaluate changes in Prospera dd-cfDNA as an indicator for biopsy proven acute rejection (BPAR), graft failure, death, development of donor-specific antibodies (DSA), chronic lung allograft dysfunction (CLAD), infection episodes and response to treatment for rejection.
4. Evaluate changes in Prospera dd-cfDNA in assessments involving standard management for acute rejection and infection events.

Eligibility Criteria:
Patients must meet all the following selection criteria to be eligible for the study:

Inclusion Criteria

1. Age 18 or older at the time of enrollment.
2. Underwent a first single or bilateral deceased-donor lung transplant. 3) Allograft was from a genetically different donor (e.g., not an identical twin).

4) Meets criteria for one of the two study cohorts:

a) Cohort 1: i) Previously enrolled and randomized in LAMBDA 001 (TBBx surveillance or Prospera surveillance) AND ii) Enrolled at least 12 and up to 18 months post-transplant b) Cohort 2: i) Not previously randomized in LAMBDA 001 (may have been enrolled if randomization did not occur) AND ii) Enrolled less than or equal to 12 months post-transplant 5) Prospera testing is planned as part of routine post-transplant management.

Exclusion Criteria

Patients are not eligible for the study if they meet any of the following criteria:

1) Recipient of multi-organ transplant at the time of lung transplant. 2) Prior recipient of any solid organ or hematopoietic (bone marrow or stem cell) transplant.

3) Human immunodeficiency virus (HIV) infection. 4) Pregnant. 5) Ongoing testing with another allograft dd-cfDNA assessment test is planned. 6) Unwilling or unable to provide informed consent. 7) Unwilling or unable to comply with study procedures.