cyrilzakka/clinical-trials huggingface dataset:
PROMPT - Palifermin in Reduction of Oral Mucositis in PBSC Transplantation

This is an open-label, single-arm, multicentre study conducted in Spain to estimate the effectiveness of palifermin administered at a dose of 60 mg/kg/day IV for 3 consecutive days before the start of the conditioning regimen and for 3 consecutive days after autologous PBSCT for treating oral mucositis in patients with NHL and MM who have received high-dose conditioning chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Non-Hodgkin's lymphoma (NHL) subjects scheduled to receive BEAM conditioning chemotherapy followed by autologous PBSCT, or multiple myeloma (MM) subjects scheduled to receive high-dose Melphalan (200 mg/m2) conditioning chemotherapy, in a one or two-day schedule, followed by autologous PBSCT
* ≥Age 18 years
* ECOG performance status \<= 2. In the MM group, ECOG status \>2 will be accepted provided that it is exclusively due to MM (e.g. pathological fracture)
* Adequate pulmonary function as measured by a corrected carbon monoxide (CO) diffusing capacity (DLCO) ≥ 60% of predicted
* Left ventricular ejection fraction (LVEF) ≥ 50%
* Minimum of 1.5 x 10\^6 CD34+ cells/kg for autologous transplantation
* Adequate haematological function (ANC ≥ 1.5 x 10\^9/L and platelet count ≥ 100 x 10\^9/L)
* Serum creatinine \<= 2.0 mg/dL
* Total bilirubin \<= 2 mg/dL
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<= 4.0 x IULN
* Negative serum or urine pregnancy test for women of child bearing potential within 14 days prior to enrolment
* Each subject must give informed consent directly or through a legally acceptable representative before participating in any study specific procedure, or receiving any study medication. Exclusion Criteria:
* History of or concurrent cancer other than NHL or MM
* Prior treatment with palifermin, or other keratinocyte growth factors (eg, KGF-2)- Prior autologous or allogeneic transplants
* Oral abnormalities defined as baseline oral assessment of WHO grade \>0
* Other investigational procedures are excluded
* Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
* Subject of child-bearing potential is evidently pregnant (eg, positive HCG test) or is breast feeding
* Subject is not using adequate contraceptive precautions
* Known to be sero-positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
* Subject has known sensitivity to any of the products to be administered during dosing, including E coli-derived products
* Subject has previously been treated on this study or with other keratinocyte growth factors
* Unwilling or unable to complete the patient-reported outcome questionnaires
* Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
Evaluation of Physiologic Parameters to Study the Mechanism of Action of the Lung Volume Reduction Coil in Subjects With Homogeneous Emphysema

The PneumRx Lung Volume Reduction Coil (LVRC) has been shown to effectively improve quality of life, exercise capacity, and static lung volumes, in patients with emphysema. The mechanism of action for these effects is believed to be related to the restoration of elastic recoil to lung parenchyma that has been damaged by emphysema. The objective of this study is to evaluate several physiologic parameters which should provide measures directly related to the mechanism of action by which the coils produce these outcomes.


Eligibility Criteria:
Inclusion Criteria:

Subject \> 35 years of age CT scan indicates homogeneous emphysema Subject has stopped smoking for a minimum of 6 months prior Subject (and legal guardian if applicable) read, understood and signed the Informed Consent form

Exclusion Criteria:

Subject has a history of recurrent clinically significant respiratory infection Subject has uncontrolled pulmonary hypertension Subject has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc Subject is pregnant or lactating Subject has an inability to tolerate bronchoscopy Subject has clinically significant bronchiectasis Subject has giant bullae Subject has had previous LVR surgery, lung transplant or lobectomy Subject has been involved in other pulmonary drug studies with 30 days prior Subject has other condition that would interfere with completion of study, follow up assessments or that would adversely affect outcomes
Brief Behavioral Activation Intervention for Depressed Asthma and Urticaria Patients

Depression and other unhealthy behaviors, such as not taking medication as prescribed and not attending doctor visits have been suggested to increase the worsening of allergic diseases (e.g. asthma, urticaria). We intend to determine whether a one-session behavioral intervention is effective in helping with depression and controlling disease symptoms. We will measure this using pre- and post-intervention surveys.

The purpose of this research study is to investigate whether a one-session behavioral activation intervention for depression can successfully reduce depression and improve asthma or urticaria disease-relevant outcomes (medication adherence, doctor's visits, substance abuse) in clinical patients with asthma or urticaria who report heightened levels of depression and are seen in the UMMC Allergy Clinic.

Eligibility Criteria:
Inclusion Criteria:

* Potential participants should be between the ages 18 and 64, seen in the UMMC Allergy Clinic with either asthma or urticaria and who report symptoms of depression in the previous 2 weeks.

Exclusion Criteria:

* Potential participants younger than 18 and older than 64 or who do not speak English or cannot comprehend the consent form or women who are pregnant are excluded.
Virtual Reality on Pain, Fear, and Emotional Appearance During Phlebotomy in Pediatric Hematology and Oncology Patients

In this study, the effect of virtual reality, which is one of the pain relief methods, on the pain, fear and emotional appearance associated with the procedure, was evaluated in children aged 4-12 years who will undergo phelobotomy in a Pediatric Hematology and Oncology outpatient clinic.

This prospective randomized controlled study was conducted in the pediatric hematology and oncology polyclinic blood collection unit of a university hospital in Turkey.

Patients undergoing phelobotomy were allocated to virtual reality or control groups according to a stratified randomization scheme.

Eligibility Criteria:
Inclusion Criteria:

the age range is between 4-12

to apply to the pediatric hematology and oncology outpatient clinic and to have blood taken

consent of the child and parent to voluntarily participate in the study

The child does not have a physical or psychological deficit that would prevent them from wearing glasses to watch virtual reality.

Exclusion Criteria:

having a fever (\>37.5C) and severe dehydration

Before the invasive procedure, the patient was given anagesics.
An Investigational Drug Study With Suberoylanilide Hydroxamic Acid in Relapsed Diffuse Large B-cell Lymphoma (0683-013)

A study to determine the safety, tolerability, and anti-tumor effectiveness of an oral investigational drug in the treatment of relapsed diffuse large B-cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be 18 years or older with relapsed Diffuse Large B-cell Lymphoma (DLBCL).
* Stable disease or better for at least 3 months on most recent treatment
* Have not received any chemotherapy, radiation therapy, major surgery, or any other investigational therapy for at least 4 weeks prior to entry in this study
* Adequate blood testing, liver, and kidney function as required by the study.
* Eligible subjects will allow tissue samples to be examined and stored.

Exclusion Criteria:

* Patient has been treated with other investigational agents with a similar anti-tumor mechanism.
* Patient should not have failed more than 3 prior treatment regimens.
Safety, Efficacy and Pharmacokinetics of Doxycycline Plus Tauroursodeoxycholic Acid in Transthyretin Amyloidosis

This study is being conducted to explore the potential benefits of a twelve-month doxycycline (at the best tolerated dose of 200 mg/day) and tauroursodeoxycholic acid (750 mg/day) treatment on disease progression in patients affected by transthyretin amyloidosis, including: 1) patients not eligible for liver transplantation; 2) patients eligible for liver transplantation, as a "bridge" therapy between the time of diagnosis and surgery, with the aim of stabilizing the disease; 3) patients showing disease progression after liver transplantation performed since at least 1 year.

It is a phase II, therapeutic exploratory, two-part, 18-month, single centre, prospective study.

Part I is a 12-month, open label treatment period in which doxycycline (200 mg/day, continuously) and tauroursodeoxycholic acid (750 mg/day continuously) are administered to 40 consenting subjects with transthyretin amyloidosis. Part II is a withdrawal period in which subjects will be monitored for disease progression. During part I, subjects will be evaluated at baseline (study Day 0), and then after 3, 6, 9 and 12 months of doxycycline plus tauroursodeoxycholic acid treatment or at premature treatment discontinuation; during part II, they will be assessed at months 15 and 18. Monthly phone contacts and blood tests will be performed to monitor potential adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Histochemical diagnosis of amyloidosis as based on detection by polarizing microscopy of green birefringent material in Congo red-stained tissue specimens;
* Molecular definition of the transthyretin (TTR) mutation or immunohistochemical staining of amyloid fibrils with anti-TTR antibody;
* ECOG performance status (PS) 0, 1, 2;
* New York Heart Association (NYHA) class ≤III
* Systolic blood pressure ≥100 mmHg (standing)
* Must have symptomatic organ involvement with amyloid to justify therapy; must have evidence of neuropathy and/or cardiomyopathy progression after liver transplantation performed since at least one year.
* Contraception for women of childbearing potential. Medically approved contraception could include abstinence. A negative serum pregnancy test is required prior to initiation of treatment with study medication.

Exclusion Criteria:

* Liver transplantation in the previous 12 months or liver transplantation anticipated in less than 6 months;
* ALT and/or AST ≥ 2 x Upper Normal Limit (UNL);
* Alkaline phosphatase ≥ 2 x UNL;
* Creatinine clearance \< 30 ml/min;
* Any other lab values that in the opinion of the investigator might place the subject at unacceptable risk for participation in the study;
* Echocardiographic ejection fraction \< 50%;
* Other neuropathies, due to vitamin B12 deficiency, alcoholism, hypothyroidism, uremia, diabetes mellitus, vasculitides;
* History of poor compliance;
* History of hypersensitivity to any of the ingredients of the study therapies;
* Use of any investigational drug, device (or biologic) within 4 weeks prior to study entry or during the study.
Tumor Microenvironment

Cancer immunotherapy has the great potential to achieve long-term survival in patients with a solid malignancy. However, the beneficial effect of cancer immunotherapy is seen in only a minority of patients. Mounting evidence suggests that immunosuppressive features in the tumor microenvironment prevent an effective antitumor defense. The aim of the investigators is to comprehensively analyze the cytokine profile and the tumor immune infiltrate in the tumor microenvironment and to investigate its prognostic significance in patients with radically resected lung adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Lung adenocarcinoma
* Tumor stage IB and II
* With or without adjuvant therapy
* Complete surgical resection (R0)
* No distant metastasis at the time of surgery (M0)

Exclusion Criteria:

• Second cancer within 5 years
Immunogenicity of One Dose of Gardasil and One Dose of Gardasil-9

This study will assess the immunogenicity of one dose of Gardasil and one dose of Gardasil-9

This is a one group exploratory study.

The main objective of this study is to assess the persistance of anti-HPV after a single dose Gardasil and the effect of one dose of Gardasil-9 when administered 3-8 years later.

Eligibility Criteria:
Inclusion Criteria: Have received a single dose of Gardasil 3-8 years before recruitement.

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Exclusion Criteria: Immunossupressed or blood coagulation problems

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Single Dose Versus 24 Hours Antibiotic Prophylaxis in Reduction Mammaplasty

Setting: Translacional Surgery Graduation Program - Universidade Federal de São Paulo and Hospital das Clínicas Samuel Libânio - Universidade do Vale do Sapucaí. Background: Breast reduction is one of the most performed plastic surgery procedures. Antibiotics are widely prescribed, on an empirical basis, to prevent surgical site infections. However, there is a lack of evidence to support its use. Objective: To compare the influence of the use of prophylatic antibiotics as a single dose or for 24 hours on surgical site infection rates following reduction mammaplasty. Methods: Randomized trial of non-inferiority, with two parallel groups, double blinded. A total of 146 breast hypertrophy patients, with reduction mammaplasty already scheduled, will be enrolled. Patients will be randomly allocated to group A, that will receive antibiotics only at the anesthesia induction (n=73), or to group B, that will receive antibiotics at the anesthesia induction and for 24 hours (n=73). None of the patients will receive antibiotics after hospital discharge. Patients will be followed-up weekly, for 30 days, regarding surgical site infection. The Centers for Disease Control and Prevention criteria will be applied. A statistical analysis of the data will be performed.


Eligibility Criteria:
Inclusion Criteria:

* 18 and 60 years of age
* body mass index (BMI) between 19 and 30 kg/m2
* breast hypertrophy according to the criteria of Sacchini et al. and Franco and Rebello

Exclusion Criteria:

* patients who had previously undergone another surgical procedure of the breast
* patients who have been diagnosed with a breast pathology
* smokers
* patients who had a child or breastfed within the last year
* patients with uncontrolled comorbidities, such as arterial hypertension or diabetes
* use of immunosuppressants
* patients who had any infection during the follow-up period, requiring the use of antibiotics
* patients who present any adverse effects due to the antibiotics during the study
* patients who miss follow-up assessments
* patients who withdraw their consent at any time
Ablative Fractional Laser for Sclerotic GVHD-Associated Joint Contractures

Graft versus host disease (GVHD) is a common complication of allogeneic stem cell transplant.Chronic GVHD is characterized by skin thickening and tightening. Advanced sclerosis can lead to reduced range of motion and incapacitating joint contractures. Once present, there are few therapeutic options. We will treat sclerosis and limb contractures with an ablative fractional laser, a device FDA-approved for scar treatment. This approach has successfully treated contracturesdue to burn scars.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be able to give informed consent
* All adult patients (18 years of age or older) Severe sclerotic skin changes of chronic graft versus host disease meeting a score of 3 on the NIH consensus criteria for organ scoring of chronic GVHD,
* a score defined by deep sclerotic features with hidebound skin which cannot be pinched together, resulting in impaired motion.
* According to the NIH criteria, the patient need not have widespread cutaneous GVHD; hidebound skin OR impaired mobility receive a score of 3 (highest score).
* Demonstrable range of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb amenable to laser therapy must be present. - - Patients must note an inability to bend the joint (e.g. foot, wrist, elbow) freely which compromises the ability to perform specific tasks (e.g. walking up or down stairs, grabbing / making a fist, lifting or raising thearms over the head). As these functional limitations are by their nature subjective (and NIH scoring criteria are themselves subjective) determination of eligibility will be made by the investigator.
* ECOG Performance Status shall be 0-3

Exclusion Criteria:

* Persons unable to provide informed consent Pregnant or nursing women, or children under age 18
* Active infections such as herpes simplex virus (HSV) Acute, untreated medical problems such as poorly-controlled diabetes, decompensated heart failure, etc.
* There are no specific contraindications to use of the laser based on skin pigmentation, sun sensitivity, history of keloids, use of specific medications, etc.
* Appropriateness for trial entry will be determined on an individual basis by the study investigators.
* Patients with ECOG Performance Status 3 will be excluded.
* Patients with ANC 1500,PLT 50, or Hgb 8.0 will be excluded.
Effects Of Gong's Versus Mulligan Mobilization In Patients With Adhesive Capsulitis

A Randomized Clinical Trial will be conducted at DHQ hospital kasur,BIT hospital kasur,Arif memorial hospital Lahore.Pre-diagnosed patients will be reassessed by applying (Shoulder Shrug Sign, Hand to neck, Hand to scapula, Hand to opposite scapula,Hand to back,Capsular pattern movement restriction)Plus all other special tests will be applied to confirm that symptoms are not due to other shoulder pathologies but are due to just adhesive capsulitis then through consecutive sampling technique on 60 patients they will be allocated using computer generated sampling(random number table) into Group A and Group B.

A Randomized Clinical Trial will be conducted at DHQ hospital kasur,BIT hospital kasur,Arif memorial hospital Lahore.Pre-diagnosed patients will be reassessed by applying (Shoulder Shrug Sign, Hand to neck, Hand to scapula, Hand to opposite scapula,Hand to back,Capsular pattern movement restriction)Plus all other special tests will be applied to confirm that symptoms are not due to other shoulder pathologies but are due to just adhesive capsulitis then through consecutive sampling technique on 60 patients they will be allocated using computer generated sampling(random number table) into Group A and Group B. Group A will be treated with Gong's mobilization and Group B will be treated with Mulligan MWM The procedures will be performed Three sets of 10 repetitions, with 1 minute rest between sets,thrice per week for a total of six weeks. Pre and post intervention values will be taken on 1st day and after 6 weeks. Outcome measures will be conducted through VAS for pain,SPADI for functional disability , goniometer for range of motion ,SF-36 for quality of life after 6 weeks. Data will be analyzed during SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Age 40 to 50 years
* Both male and female
* Pre-diagnosed Unilateral Primary Frozen shoulder patients
* Prediagnosed Stage 3(Frozen phase) patients(27)

Exclusion Criteria:

* Patients with previous surgery in the shoulder joint
* History of recent fracture or severe trauma to the shoulder
* Diagnosed instability or previous history of dislocation
* Systemic inflammatory conditions(e.g.rheumatoid arthritis)
The Clinical Characteristics and Efficacy of Immunotherapy in First-line PD-L1-negative Advanced NSCLC Patients

This study aims to include patients with advanced or metastatic non-small cell lung cancer who are PD-L1 negative and receiving first-line immunotherapy in routine clinical practice.

This study aims to include patients with advanced or metastatic non-small cell lung cancer who are PD-L1 negative and receiving first-line immunotherapy in routine clinical practice. Clinical treatment of patients will not be intervened unless disease progression, intolerable toxicity, initiation of new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, or other circumstances deemed appropriate by the investigator to discontinue treatment, whichever occurs first. The primary objective of the study is for investigators to assess the one-year progression-free survival (PFS) rate of immunotherapy as first-line treatment in PD-L1 negative advanced or metastatic NSCLC, evaluated according to RECIST 1.1 criteria.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained before implementing any trial-related procedures;
* Aged 18-80 years;
* Wild-type EGFR/ALK;
* Patients with locally advanced (stage IIIb/IIIc), metastatic, or recurrent (stage IV) NSCLC confirmed by histology or cytology, who are not eligible for curative surgery and cannot undergo definitive radiotherapy/chemotherapy, according to the 8th edition of the TNM staging classification by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer;
* PD-L1 negative；
* Patients receiving first-line immunotherapy (such as PD-1/PD-L1 inhibitors).

Exclusion Criteria:

* The patient refused to join this study and declined follow-up.
Study of Islet Transplantation in Type 1 Diabetic Kidney Transplant Recipients

The purpose of the study is to learn if islet transplantation is an effective treatment for Type 1 diabetes in people who have had a kidney transplant.

The primary objectives of the study are:

- To set up islet transplantation in patients who have had a kidney transplant and who are using an immunosuppressive regimen that works

The Secondary objective of the study is:

* To find out if successful islet transplantation leads to improved metabolic control and reduced renal complication from diabetes

Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence. For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft. Induction therapy for subsequent transplants will be 2doses of basiliximab.

All patients will receive Etanercept to promote engraftment.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects
* Age 18 to 70 years of age
* Have insulin dependent Diabetes Mellitus Type 1
* Are post-renal transplant on maintenance immunosuppression with stable renal function
* HbA1c \> 7.5% or \< 7.5% and hypoglycemia unawareness

Exclusion Criteria:

* Weight more than 90 kg
* Insulin requirement \> 60 Units/day
* Other (non-kidney) organ transplants except prior failed pancreatic graft.
* Untreated or unstable proliferative diabetic retinopathy
* Presence of de novo antibody production since the renal allograft or either Class I or Class II panel-reactive anti-HLA antibodies
* Active infection
* Negative screen for Epstein-Barr virus (EBV)
* Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin
* History of Factor V Leiden mutation
* Any coagulopathy or medical condition requiring long-term anticoagulant therapy (e.g. warfarin) after transplantation (low-dose aspirin treatment is allowed) or subjects with international normalized ratio (INR) \> 1.5
* Severe co-existing cardiac disease
* Persistent elevation of liver function tests at the time of study entry
* Acute or chronic pancreatitis
* Male subjects with elevation of prostate specific antigen
* Pregnancy
* Positive screen for polyoma (BK) virus
* Untreated hyperlipidemia
* Recent hemorrhagic stroke
* Factors associated with an increased risk of bleeding

Contact PI for complete Incl-Excl criteria list.