cyrilzakka/clinical-trials huggingface dataset:
Chidamide for Patients With Relapse or Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma

Study of Chidamide as a single-agent treatment for patients with relapse or refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL)

Chidamide，a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to observe the efficacy and safety of Chidamide as a single-agent treatment in patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL). Moreover, the aim was to study the correlation of clinical efficacy to mutation of certain genes as well.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL) according to "2016 WHO classification of tumors of haematopoietic and lymphoid tissues";
2. Patients must have received systemic treatment (including chemotherapy or Hematopoietic stem cell transplantation), but did not achieve remission or had relapse after remission;
3. At least one measurable lesion;
4. Age 18-75 years, male or female;
5. ECOG performance status 0-1;
6. Without bone marrow involvement. Blood routine test: absolute neutrophil count ≥1.5 × 109/L, platelet ≥80 × 109/L, Hb ≥ 90g/L;.
7. Life expectancy no less than 3 months;
8. Not received chemotherapy, targeted medicine or stem cell transplantation 3 weeks before enrollment;
9. Patients have signed the Informed Consent Form.

Exclusion Criteria:

1. Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures.
2. QTc elongation with clinical significance ( male˃ 450ms, female˃ 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment;
3. pericardial effusion ≥10mm sum of echo-free spaces by echocardiography;
4. Patients have undergone organ transplantation;
5. Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment.
6. Patients with active hemorrhage.
7. Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction.
8. Patients with active infection, or with continuous fever within 14 days prior to enrollment.
9. Had major organ surgery within 6 weeks prior to enrollment.
10. Impaired liver function ( Total bilirubin ˃ 1.5 times of normal maximum, ALT/AST˃ 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST ˃ 5 times of normal maximum), impaired renal function (serum creatinin˃ 1.5 times of normal maximum).
11. Patients with mental disorders or those do not have the ability to consent.
12. Patients with drug abuse, long term alcoholism that may impact the results of the trial.
13. Patients who have central nervous system involvements;
14. Non-appropriate patients for the trial according to the judgment of the investigators.
Reaction Time After Mobilization

This clinical trial aims to look at the influence of wrist Mulligan mobilizations on hand reaction time in healthy people. The main question it aims to answer is:

1-Do hand mobilizations reduce reaction time?

In the treatment of musculoskeletal problems, manual therapy techniques are often used to restore movement and alleviate pain. The period between the initial muscular response or movement in response to a stimulus is referred to as reaction time. There is growing evidence for the benefit of manual mobilization for limb dysfunction, including shoulder and elbow pain, but there is little literature on hand mobilization and little research on its influence on hand reaction time in healthy individuals.

The study comprised 60 healthy participants who completed a voluntary consent form. They were divided into two groups: research and sham mobilization. Participants in the study group had mediolateral wrist glide, anteroposterior 1st MCP glide, and anteroposterior and mediolateral glide. Applications were performed to the wrist, first metacarpal, and CMC joints in three sets of six repetitions. The patient in the sham mobilization group remained in the same posture for the same amount of time without gliding. The Nelson Hand Reaction Test was used to assess hand reaction before and after application. A 50 cm ruler was used, and the average of five measurements in cm was recorded and interpreted to sec.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers were included if they were 18 years of age or older and had no communication disorders.

Exclusion Criteria:

* Any elbow, hand, shoulder, or neck discomfort, diagnosis, or pain in the last 6 months, a neurological disorder affecting sensation, or unwillingness to participate in the study.
Allium Sativum Oil and Turmeric Gel as Alternative Non-vital Pulpotomy Medicaments in Primary Teeth.

The purpose of the study is to use Allium sativum oil and Turmeric gel as non-vital Pulpotomy medicaments in primary teeth by evaluating their antibacterial effect against Streptococcus mutans and Lactobacillus acidophilus.

It is hypothesized that there is no difference in the antibacterial effect of Allium sativum oil and Turmeric gel when used as non-vital Pulpotomy medicaments.

It is a multi-arm parallel Randomized Controlled Trial in which forty patients aged between 4 to 8 years, each containing at-least one non-vital primary molar, will be selected and randomly divided into Group A (Allium sativum oil) and Group B (Turmeric gel). Non-vital Pulpotomy will be performed by removing the coronal necrotic pulp. Sterile paper point will be dipped in the root canals and taken to the laboratory. Cotton pellets soaked in the respective medicaments will be placed over the root canal orifices and filled temporarily. Patients will be recalled after one week. Samples will be again taken, and tooth restored. Comparison between bacterial count at baseline and after one week of treatment will be made and expressed as Colony-Forming Units/ml (CFU/ml).

Eligibility Criteria:
Inclusion Criteria:

1. Cooperation of patients and consent of parents.
2. Patients with ASA classification I and II (mild to moderate systemic disease).
3. Non-traumatic extensively carious hence restorable primary molars.
4. No history of antibiotic use for 2 weeks.
5. Presence of following clinical signs or symptoms suggestive of nonvital tooth such as tenderness on percussion, non-responsive to cold test, periapical/furcal radiolucency, localized gingival/mucosal soreness/ redness/ swelling, and/or slight mobility-grade I.

Exclusion Criteria:

1. History of allergy to anesthetics and latex.
2. Radiographic evidence of pulpal floor opening into the furcation area
3. More than half of the roots resorbed.
A Phase 1 Study of Brentuximab Vedotin Given Sequentially and Combined With Multi-Agent Chemotherapy for CD30-Positive Mature T-Cell and NK-Cell Neoplasms

The purpose of this study is to assess the safety profile of brentuximab vedotin sequentially and in combination with multi-agent chemotherapy in front-line treatment for CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma. It is a phase 1, open-label, dose escalation study in three arms designed to define the MTD, PK, immunogenicity, and anti-tumor activity of brentuximab vedotin in sequence and in combination with multi-agent front-line chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Treatment-naive CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma
* Measurable disease of at least 1.5 cm
* ECOG performance status less than or equal to 2

Exclusion Criteria:

* Known cerebral/meningeal disease, including history of progressive multifocal leukoencephalopathy
* Current diagnosis of primary cutaneous anaplastic large cell lymphoma, mycosis fungoides, Sezary syndrome or other primary cutaneous lymphomas; extranodal NK/T-cell lymphoma, nasal type
* History of another primary malignancy that has not been in remission for at least 3 years
* Left ventricular ejection fraction \<45% or symptomatic cardiac disease, or myocardial infarction within the past 12 months
* Viral, bacterial, or fungal infection within two weeks prior to the first dose of brentuximab vedotin
* Known human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus positive status
Examining the Genetic Factors That May Cause Chronic Obstructive Pulmonary Disease (COPD)

Chronic obstructive pulmonary disease (COPD) is a long-term lung disease that is often caused by cigarette smoking. The purpose of this study is to evaluate whether certain genetic factors predispose some smokers to develop COPD more than others.

COPD is a disease in which the lung airways are damaged and partly obstructed, making it difficult to breathe. Millions of people in the United States have COPD, and it is the third leading cause of death in the United States. Symptoms include coughing, excess mucus production, shortness of breath, wheezing, and chest tightness. Emphysema and long-term bronchitis are the two most common manifestations of the disease. The most common risk factor for developing COPD is cigarette smoking; however, only 15% to 20% of smokers develop COPD in their lifetimes. It is not known why some smokers develop COPD and some do not, but certain genetic factors, combined with exposure to cigarette smoke, may increase the likelihood of developing COPD. This study will analyze DNA from current and former cigarette smokers to identify genetic factors and markers that may indicate a predisposition to developing COPD.

This study will enroll African-American and white cigarette smokers and former cigarette smokers both with and without COPD. Participants will attend one study visit during which they will complete questionnaires about lung symptoms, breathing difficulties, medical and family history, and quality of life. They will also undergo blood collection, a physical exam, lung function testing, and a walking test to measure endurance. Participants will undergo a high resolution computed tomography (CT) chest scan and a medical record review. Study researchers will contact participants up to four times a year for 15 years to collect follow-up medical information. Five-year, ten-year, and fifteen-year follow-up visits including a similar study protocol as the baseline visit will be performed on all available subjects.

Eligibility Criteria:
Inclusion Criteria:

* At least 10 pack-years of cigarette smoking (although a of nonsmoking controls is also being enrolled)
* Self-designation of non-Hispanic white or African-American

Exclusion Criteria:

* Other lung diseases (except for asthma in participants with COPD)
* Pregnant
* Cancer (other than skin cancer) in the 5 years prior to study entry
* Received antibiotics for a COPD exacerbation in the 1 month prior to study entry
* First- or second-degree relative of a previously enrolled study participant
Comparison of Cow Milk and 15% Hypertonic Saline in the Treatment of Rectal Prolapse in Children

To see the outcome of results of Cow Milk \& Hypertonic Saline in the treatment of Rectal Prolapse in Children

Sclerotherapy is the least invasive procedure used in management of grade I/II rectal prolapse, with a success rate of around 80%, and generally considered as the first choice for uncomplicated and recurrent prolapse. Several sclerosing agents such as 15% hypertonic saline, 5% Phenol in almond oil and cow milk have been used and reported in the literature. Present study is designed to determine the efficacy of cow milk and 15% hypertonic saline in the management of children with grade I/II rectal prolapse.

All the details will be entered on the proforma which will include resolvement of rectal prolapse and which agent has adverse effects like recurrence, fecal incontinence and anal stenosis.

Eligibility Criteria:
Inclusion Criteria:

* All children with Grade I and II rectal prolapse
* Age \<12 years
* Both genders

Exclusion Criteria:

* Rectal prolapse secondary to causes like ulcerative colitis and crohn's disease
* Past surgical history on the pelvic floor,
* Neurological diseases like rectal polyps, congenital megacolon, Hirschsprung disease, sacrococcygeal teratoma, neural tube defects, cauda equina syndrome
* Where parents are not willing to participate in the study
The Influence of Different At-home Exercise Strategies on 24h Glycemic Control

This study will determine how different at-home exercise strategies influence 24hr glycemic control in women with metabolic dysfunction.

Elevations in blood glucose concentration increase risk for cardiometabolic diseases including type 2 diabetes and cardiovascular diseases. Exercise can improve glycemic control, but there is limited research comparing the effectiveness of different exercise strategies in women. The aim of this study is to examine, under free-living conditions, how performing either walking and bodyweight interval exercise after dinner influences glycemic control in women with or at risk for type 2 diabetes. Glycemic control will be measured with continuous glucose monitors.

Eligibility Criteria:
Inclusion Criteria:

* Females
* no cancer history
* ≥50 years old
* Have metabolic dysfunction (defined as self-reported diagnosis of pre-diabetes, type 2 diabetes, or at least moderate Canadian diabetes risk (CANRISK) score)
* Owns a smartphone with Bluetooth capability with Apple or Android operating system
* deemed safe to exercise as per the CSEP Get Active Questionnaire
* Enrolled in NCT05454943

Exclusion Criteria:

* Type 1 diabetes
* Taking exogenous insulin, sulfonylureas, or GLP-1 receptor agonists
* Self-reported history of an eating disorder
* BMI \<18.5 kg/m
* Working night or rotating shifts
* Eating window \<12 hours or consistently eating less than 3 meals/day in the past 3 months
* Major dietary changes within the past 3 months (i.e. calorie counting, ketogenic diet)
Vitamin D in Systemic Sclerosis Patients With Periodontitis

Vitamin D has been considered to possess anti-inflammatory and antimicrobial activity which may be a link for the known interaction of Systemic Sclerosis (SSc) and coronary heart disease (CHD). This study investigated the association between serum vitamin D levels and SSc and periodontitis in patients with SSc, CP and with CHD.

Furthermore, the objective was to determine if periodontitis and CHD had an impact on serum vitamin D levels.

Using a cross-sectional design, a total of 42 patients with SSc, 43 patients with CHD, 41 patients with both SSc and CP, and 42 healthy patients were enrolled in the present study.

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least twenty teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.
Testing the Effectiveness of Henna on Managing PPE

The palmar-plantar erythrodysesthesia (PPE) is the only clinical adverse event that commonly occurs with capecitabine and/or pegylated liposomal doxorubicin treatment and it warrants special attention because it is the most common dose-limiting toxicity. this study is designed to test the effectiveness of a henna treatment protocol in the management of capecitabine and/or pegylated liposomal doxorubicin induced palmar-plantar erythrodysesthesia.

This will be a randomized double-blind, placebo-controlled study with 80 cancer patients that will receive chemotherapy treatment with capecitabine and/or pegylated liposomal doxorubicin. The selection of potential participants will be based on pre-determined inclusion and exclusion criteria. Patients will be randomly allocated either to the treatment group or the placebo group. Treatment will be delivered twice a week and assessments will take place at 2, 3, 4, 5 and 6 weeks.

The intervention group will receive the application of henna to the hands and/or feet of the patients and the control group will receive the placebo.

At both baseline and follow-up, patients in both groups will be assessed for their degree of palmar-plantar erythrodysesthesia, the Quality of Life, the need for dose-limiting due to PPE and Pain intensity using standardized rating scales. Data will be analysed with inferential and descriptive statistics.

Eligibility Criteria:
Inclusion Criteria:

* Adult cancer patients (\>18)
* Patients receiving capecitabine and/or PLD as monotherapy or in combination with other agents
* Patients that will experience PPE grade 1 or above
* Willing to participate
* Ability to complete the psychometric assessments.
* A performance status of two or less on the Eastern Cooperative Oncology Group (ECOG)

Exclusion Criteria:

* Patients with hypersensitivity to natural henna.
* Patients with pre-existing dermatological condition affecting the hands or feet that may limit the interpretation of results
* Patients on Pyridoxine or nicotine patches
* Patients with a previous history of PPE
* Patients whose chemotherapy was discontinued for more than a week
Comparison of the Efficacy of Phototherapy Using Blue LED's With Wavelength 478 vs. 459 nm.

Treatment of neonatal jaundice is phototherapy with blue light at wavelength about 460 nm and irradiance \> 30 uw/cm2/nm. Though, recent in vitro models have suggested that a wavelength of 478 nm should be optimal in reducing total serum bilirubin. The aim of this study is therefore to compare the efficiency of phototherapy with light emitting diodes (LED's) of 478 vs. 459 nm., respectively.

This is a prospective randomised study of the efficacy of phototherapy. Inclusion criteria are gestational age \> 33 weeks and birth weight \> 1800 grams, uncomplicated neonatal jaundice. The infants should be treated with phototherapy in a cradle for 24 hours, which is routine standard of care. Exclusion criteria is haemolytic disease. Total serum bilirubin (TSB) is measured before and after 24 hours of phototherapy. The infants are enrolled and randomised consecutively by the neonatologist using sealed and opaque envelopes.

Power calculation based on expected difference in decrease of TSB of 6% between the two groups and a significance level of 0.05, showed that 48 infants should be enrolled in each group.

Eligibility Criteria:
Inclusion Criteria:

* Indication for phototherapy with single light
* Gestational age \> 33 weeks
* Birth weight \> 1800 grams
* Should be treatable in a cradle

Exclusion Criteria:

* Haemolytic disease
* Indication for double/triple phototherapy or exchange transfusion
Endoscopic Versus Radiologic Biliary Drainage for Perihilar Malignant Obstruction

This retrospective monocentric study aims at comparing multimodality endoscopic biliary drainage versus percutaneous radiologic biliary drainage in case of perihilar malignant obstruction.

Data from patients admitted in the Nancy University Hospital, France, between january 2016 and march 2022 with jaundice and perihilar obstruction will be retrospectively collected.


Eligibility Criteria:
Inclusion Criteria:

* hospitalization between january 2006 and march 2022
* perihilar obstruction
* indication of biliary drainage

Exclusion Criteria:

* distal biliary obstruction
* perihilar obstruction without indication of biliary drainage
Understanding and Restoring Dopaminergic Function in Fibromyalgia Patients

Fibromyalgia (FM) is a very prevalent and debilitating chronic pain disorder that is difficult to treat. Mindfulness-based techniques are regarded as a very promising approach for the treatment of chronic pain and in particular FM. The Mindfulness-Oriented Recovery Enhancement (MORE) intervention, a mindfulness-based group intervention, has shown beneficial effects in opioid-treated chronic pain patients, including reduced pain severity, functional interference, and opioid dosing, by restoring neurophysiological and behavioral responses to reward. First evidence for a hypodopaminergic state and impaired reward processing in FM have been reported. However, little is known about its impact on dopamine (DA) function and in particular with regard to DA responses to monetary reward in FM. The aim of the present study protocol is to evaluate if MORE is able to restore the DA function in FM patients, in particular with regard to the DA responses to reward, and to reduce pain and mood complaints in FM.

the present study is a multi-center randomized controlled trial (RCT) with 3 time points: before the intervention, after completion of the intervention and 3-months after completion of the intervention. Eighty FM patients will be randomly assigned to either the MORE intervention (N=40) or to a wait-list control group (N=40). Additionally a comparison group of healthy women (N=20) will be enrolled. The MORE intervention consists of eight 2-hour long group sessions administered weekly over a period of 8 weeks. Before and after the intervention, FM participants will undergo \[18F\] DOPA Positron Emission Tomography (PET) and functional magnetic resonance (MR) imaging while performing a monetary reward task. The primary outcome will be endogeneous DA changes measured with \[18F\] DOPA PET at baseline, after the intervention (after 8 weeks for control group), and at 3 months' follow-up. Secondary outcomes will be (1) clinical pain measures and FM symptoms using standardized clinical scales 2) functional brain changes 3) measures of negative and positive affect, stress and reward experience in daily life using the Experience Sampling method (ESM) 4) biological measures of stress including cortisol and alpha-amylase.

Design: If the findings of this study confirm the effectiveness of MORE in restoring DA function, reducing pain and improving mood symptoms, MORE can be judged to be a promising means to improve quality of life in FM patients. The findings of this trial may inform health care providers about the potential use of the MORE intervention as a possible non-pharmacological intervention for FM.

Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgia syndrome
* no psychiatric disorders
* right handed
* older than 18 years,

Exclusion Criteria:

* male sex
* history of neurological disorders
* left handed
* psychiatric disorders
* current substance or tobacco abuse
* current and past substance dependence
* schizophrenia spectrum disorder
* any other form of chronic pain apart from Fibromyalgia
Study in Intensive Care Patients Regarding the Effect of Inhaled AP-301 After Primary Graft Dysfunction After Lung Transplantation

The purpose of this study is to investigate the effect of orally inhaled AP-301 on primary graft dysfunction after lung transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Being a male or female recipient on the AKH's waiting list for primary single or double LuTX
* PGD score ≥ 1 within 72 hours after LuTX
* Informed consent is available

Exclusion Criteria:

* History of clinically relevant allergies or idiosyncrasies to AP301 or any other inactive ingredient(s) of the investigational product
* Postoperative ECMO support
* Paediatric /adolescent recipients (\< 18 years)
* Lobar transplantation
* Retransplantation
* Combined solid organ transplants
* Participation in other drug trials