cyrilzakka/clinical-trials huggingface dataset:
BandGrip® Closure of Surgical Incisions Following Arthroscopic Surgery

A single-arm, prospective, unblinded, post marketing, single center study using BandGrip to close incisions post arthroscopic shoulder surgery.

The study objective is to assess the ease of incision closure, the cosmetic appearance of the wounds on follow-up, and general subject satisfaction with the appearance of the healed incisions following use of BandGrip. Up to 25 subjects will be enrolled at a single center.

Subjects who have undergone arthroscopic surgery of the shoulder and require closure of one or two skin puncture sites will be enrolled. Following incision closure subjects will be seen at the time of BandGrip removal (approximately 7-14 days after closure) and at 30 days for assessment of the incisions.

The incidence of wound closure for each treated puncture site, defined as continuous approximation of wound margins from the time of wound closure until the day of removal of the wound closure device without dehiscence or need for reclosure.

Eligibility Criteria:
Inclusion Criteria:

* 1. Subject is ≥ 18 years of age. 2. Subject had an arthroscopic shoulder procedure and has at least two skin incisions that are assessed as requiring temporary approximation of the skin edges.

  3. The length of the subject's surgical incisions is less than or equal to 1.5 inches.

  4. Subject must be willing to follow instructions for wound care provided by investigator and refrain from picking at the treatment device, applying topical medications to the wound, and swimming or soaking in a tub until the wound closure device is removed.

  5. Subject agrees to return for all required follow-up evaluations. 6. Subject is able to comprehend and give informed consent for participation in this study.

Exclusion Criteria:

* 1. Subject has a recent history of bleeding, coagulation, and/or clotting disorders.

  2. Subject is on dialysis. 3. Subject has a history of inflammatory and/or allergic diseases or conditions of the skin involving the location of the incisions (e.g., psoriasis, Eczema, or dermatitis).

  4. Subject has a history of drug abuse. 5. Subject has a history of chronic use of oral steroids or immunosuppressants. 6. Subject has known personal or family history of keloid or hypertrophic scarring.

  7. Subject has a history of abnormal wound healing. 8. Subject's incisions are in a high skin tension area. 9. Subject has a known allergy to BandGrip material (polycarbonate). 10. Subject has a known cognitive or psychiatric disorder. 11. Subject has an incision at site of active rash/skin lesion making evaluation difficult.
Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD)

This is a Phase 3 Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects with Dialysis-Dependent Chronic Kidney Disease (DD-CKD)


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects ≥18 years of age
* Receiving chronic maintenance in-center hemodialysis (3 times per week) for end-stage kidney disease
* Currently maintained on ESA therapy
* Mean screening Hb between 8.0 and 11.0 g/dL (inclusive)

Exclusion Criteria:

* Anemia due to a cause other than CKD or presence of active bleeding or recent blood loss
* Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
* Red blood cell transfusion within 4 weeks prior to or during screening
* Anticipated to recover adequate kidney function to no longer require hemodialysis during study participation
A Study in Healthy Men to Test How BI 1810631 is Taken up and Processed by the Body

Part A - the primary objective is to assess the mass balance and total recovery of \[14C\]-radioactivity in urine and faeces after oral single dose administration of BI 1810631 (C-14) (test treatment T1) in healthy male subjects.

Part A - the secondary objective is to assess concentrations of BI 1810631 and \[14C\]-radioactivity in plasma.

Part B - the primary objective is to investigate the absolute bioavailability of BI 1810631 administered as film-coated tablet (test treatment T2, not radio-labelled) compared with BI 1810631 (C-14) (reference treatment R) administered as intravenous microtracer.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 55 years (inclusive)
3. Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive)
4. Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion Criteria:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 145 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 45 to 90 mmHg, or pulse rate outside the range of 40 to 100 beats per minute (bpm)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply
INST Phase II Trial of Gemcitabine and Irinotecan in Patients With Relapsed or Refractory Lymphoma.

Primary objectives

* Assess the response rate in patients with recurrent or refractory B-cell NHL or Hodgkins disease, treated with the combination of the gemcitabine and irinotecan.

Secondary objectives

* Assess progression free survival in these patients treated with this regimen.
* Assess toxicity of this regimen in this group of patients.

The purpose of the study is to see how well patients with relapsed or refractory lymphoma respond to treatment with Gemcitabine and Irinotecan. Patients on this study take part because they have relapsed or refractory lymphoma. Additionally, the study will assess treatment-related side effects and time until disease progression or recurrence.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a histologic diagnosis of non-HIV related B-cell NHL or Hodgkins disease are eligible.
2. Patients should have documented evidence of refractory or relapsed NHL or Hodgkins disease for inclusion.
3. Patient should have received 1 or more prior chemotherapeutic regimens for relapse, and should have completed last course of treatment at least 3 weeks prior to enrollment.
4. The patient must have bidimensionally measurable or evaluable disease.
5. Age \> 18 years.
6. ECOG Performance status \< 2
7. Informed consent.
8. ANC \> 1.5, platelet count \> 100K, creatinine\< 2.0, bilirubin \< 3
9. Female patients must have a negative pregnancy test.
Glutamine With Topical Corticosteroids for Lichen Planus Treatment

Lichen planus (LP) is an inflammatory skin disease of unknown etiology. Glutamine promotes protein and collagen synthesis, imparts immunity, and maintains the alimentary canal mucosa structure.

Lichen planus (LP) is an inflammatory skin disease of unknown etiology. Recently, increased oxidative stress has been implicated in the pathogenesis of erosive oral lichen planus (EOLP). Glutamine is a source of energy for fibroblasts, immunocompetent cells, and intestinal epithelial cells involved in collagen production. It promotes protein and collagen synthesis, imparts immunity, and maintains the alimentary canal mucosa structure.

The aim of this study is to evaluate the effect of Glutamine combined with topical corticosteroid in the treatment of oral erosive LP.

Thirty patients with a confirmed clinical and histopathologic diagnosis of OLP recruited in this study and divided into 2 equal groups, each consisting of 15 subjects. Group 1 consists of patients treated with topical steroids plus antifungal (conventional therapy); Group 2 consists of patients treated with Glutamine combined with topical steroids plus antifungal.

Eligibility Criteria:
Inclusion Criteria:

1. Patients clinically and histopathologically diagnosed to be suffering from EOLP.
2. Patients who had symptoms i.e. pain and/or burning sensation secondary to EOLP.
3. Patients under stressful life conditions as evidenced by ISMA-UK Stress Questionnaire
4. Males and Females with an age ranging from 30-60years

Exclusion Criteria:

1. Patients suspected to have a lichenoid drug reaction or lichenoid contact allergy.
2. Patients suffering from any systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)
3. Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.
Twice-per-weekSelinexor, 2 Days Melphalan

Twice-per-week Selinexor, 2 days Melphalan plus BU2FLU3 compared with BU3FLU5 for elder high-risk acute myeloid leukemia undergoing allogenic hematopoietic cell transplantation: a multi-center randomized phase 3 trial

Twice-per-week Selinexor, 2 days Melphalan plus BU2FLU3 compared with BU3FLU5 for elder high-risk acute myeloid leukemia undergoing allogenic hematopoietic cell transplantation: a multi-center randomized phase 3 trial Primary Objective The primary objective of this study is to compared 1-year RFS between Sel2Mel2BU2FLU3 and BU3FLU5 groups for elder AML in CRc undergoing allo-HCT.

Secondary Objective The secondary objective of this study is to compare leukemia relapse, engraftment, GVHD, OS, TRM, AEs and RRT between Sel2Mel2BU2FLU3 and BU3FLU5 groups

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients with high-risk acute myeloid leukemia (excluding acute promyelocytic leukemia).

  2. Recipients of allogeneic hematopoietic stem cell transplantation (including HLA-matched or mismatched allogeneic transplantation as well as unrelated donor transplantation).

  3. Age ≥ 55 years. 4. Disease status prior to allogeneic transplantation must be complete remission (CRc), confirmed by bone marrow analysis within three days prior to randomization.

  5. Karnofsky Performance Score (KPS) of at least 60. 6. Informed consent must be signed prior to the commencement of the study procedures. If the patient's signature would be detrimental to their treatment due to their medical condition, the informed consent may be signed by a legal guardian or an immediate family member of the patient.

Note: \*High-risk AML: ① Patients classified as high-risk according to the ELN 2022 grading criteria. ② AML patients with persistent MRD positivity prior to transplantation. ③ Patients with refractory or relapsed AML.

Exclusion Criteria:

* 1. Previous history of hematopoietic stem cell transplantation. 2. Active cardiac disease, defined as one or more of the following:

  1. History of uncontrolled or symptomatic angina.
  2. Myocardial infarction within the last 6 months prior to study enrollment.
  3. History of arrhythmias requiring medication or with clinically significant symptoms.
  4. Uncontrolled or symptomatic congestive heart failure (NYHA class \> 2).
  5. Ejection fraction below the lower limit of the normal range. 3. Respiratory failure (PaO2 ≤ 60 mmHg). 4. Liver dysfunction (total bilirubin ≥ 3 mg/dL, transaminases \> twice the upper limit of normal).

  5. Renal dysfunction (creatinine clearance rate \< 30 mL/min). 6. Presence of psychiatric disorders or other conditions that prevent cooperation with the study treatment and monitoring requirements.

  7. ECOG performance status of ≥ 4. 8. Uncontrolled or active infection. 9. Any condition that impairs the ability to provide informed consent. 10. Any conditions deemed unsuitable for enrollment by the investigator prior to randomization.
MK0457 (an Aurora Kinase Inhibitor) Study in Patients With Advanced Colorectal Cancer and Other Advanced Solid Tumors (0457-001)

Study with an investigational drug in patients with recurrent or non-responsive colorectal cancer or other advanced solid tumors.

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).


Eligibility Criteria:
Inclusion Criteria:

* In Part I, patients who are at least 18 years of age with advanced solid tumors and colorectal cancer will be eligible for the first part of this study. Patient must have recovered from and be at least 3 weeks from previous cancer treatment.
* In Part II, only patients with colorectal cancer will be eligible to participate. The patients may have received up to 3 prior treatments for their colorectal cancer. Patients must have recovered from and be at least 3 weeks from previous therapy.

Exclusion Criteria:

* Patients who have had treatment with any investigational drug within the past 30 days.
* Patients who have certain types of blood cancers such as leukemia or lymphoma.
* Patients who have uncontrolled congestive heart failure (CHF), chest pain, or heart attack within the past 3 months.
* Patient is pregnant or nursing.
Ketamine Infusion for Adolescent Depression and Anxiety

The purpose of this study is to determine the tolerability and short-term efficacy of a single ketamine infusion for the treatment of adolescents with 1) medication-refractory major depressive disorder (MDD) and/or 2) medication-refractory anxiety disorders (social anxiety disorder, panic disorder, generalized anxiety disorder and/or separation anxiety disorder).

We will conduct a crossover trial in which as many as 36 adolescents (18 with MDD and 18 with anxiety disorders) will be given a single infusion of ketamine (study drug) or midazolam (active control). MDD symptoms and anxiety symptoms will be monitored over a two-week period. If applicable, comorbid school refusal symptoms will also be monitored over a two-week period for both cohorts. A 2-week washout period will be required between infusion doses. Our primary outcomes will be 1) improvement in MDD symptoms (measured by Montgomery-Asberg Depression Rating Scale, revised (MADRS) score) 1 day after infusion, for the cohort of subjects enrolled in the MDD arm of this trial and 2) improvement in the anxiety symptoms (measured by the Multimodal Anxiety Scale for Children (MASC) acute physical symptoms subscale) for the cohort of subjects enrolled in the anxiety disorders arm of the trial.

Eligibility Criteria:
Inclusion:

MDD Cohort:

* Meet DSM-5 criteria for Major Depressive Disorder by structured interview (MINI-KID)
* CDRS-R score \>40.
* Failure to achieve remission with at least 1 adequate prior antidepressant trial (e.g. SSRI, SNRI, or TCA), meaning at least 8 weeks at therapeutic dosing, including at least 4 weeks of stable dosing.

Anxiety Cohort:

* Meet DSM-5 criteria for any of the following anxiety disorders: Social Anxiety Disorders, Generalized Anxiety Disorder, Separation Anxiety Disorder and/or Panic Disorder by structured interview (MINI-KID)
* ADIS Clinical Severity Rating ≥4 (moderately severe) for any of the 4 included anxiety disorders
* Failure to achieve remission with at least 1 adequate prior anxiolytic medication trial (e.g. SSRI, SNRI, or TCA), meaning at least 8 weeks at therapeutic dosing, including at least 4 weeks of stable dosing.
* Failure to achieve remission with previous CBT or subject declines current CBT therapy

Both cohorts:

* Stable psychiatric medications and doses for the month prior to enrollment. Subjects may continue to engage in any ongoing psychotherapy.
* Medically and neurologically healthy on the basis of physical examination and medical history.
* Parents able to provide written informed consent and adolescents must additionally provide assent.

Exclusion:

* Current inpatient hospitalization or active suicidal ideation requiring referral for inpatient hospitalization for safety.
* History of psychotic disorder or manic episode diagnosed by MINI-KID
* History of substance dependence diagnosis by MINI-KID (excluding tobacco) or positive urine toxicology.
* Pregnancy (urine pregnancy tests on the day of scans for menstruating girls).
* Inability to provide written informed consent according to the Yale Human Investigation Committee (HIC) guidelines in English.
SMILE Trial - Imaging Sub-Study

This is a pilot sub-study of an ongoing trial comparing N2O to midazolam in MDD and will examine neuroimaging correlates of treatment response.

Magnetic resonance imaging (MRI) scans of MDD-affected brains have revealed changes in structural and functional connectivity compared to healthy subjects. This pilot sub-study examines structural and functional connectivity associated with MDD-affected patient participants' responsiveness to N2O compared to the midazolam placebo, which induces similar sedative effects. The investigators intend to address the changes in brain functional activity and connectivity between baseline and after a four-week intervention course involving weekly nitrous oxide inhalations measured by MRI.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for main nitrous oxide (SMILE) study

Exclusion Criteria:

* Contraindication for undergoing MRI scans (e.g., hip circumference \< 180 cm or metal in the body)
Thoracic Paravertebral Blocks Using a Combination of Ropivacaine and Dexmedetomidine

The investigators designed a study to assess whether thoracic paravertebral blocks using a combination of ropivacaine and dexmedetomidine prolong nerve block duration.

The investigators designed a study to assess whether thoracic paravertebral blocks using a combination of ropivacaine and dexmedetomidine prolong nerve block duration. The effects of dexmedetomidine have only been compared at lower doses. This trial examined the effect of greater dose of dexmedetomidine on thoracic paravertebral block analgesia duration.

Eligibility Criteria:
Inclusion Criteria:

* Patients were included in the study if they were ethnic Chinese,
* American Society of Anesthesiologists (ASA) physical status I or II,
* candidates for general anesthesia undergoing thoracic surgery

Exclusion Criteria:

* Patients were excluded if they do not want to cooperate with the test,
* had a history of radial artery puncture or coronary artery bypass grafting,
* had acute vessel trauma,or had been diagnosed with Raynaud' disease,
* had suffered from mental or neurological disorders
Effects of Low-Speed and High-Speed Resistance Training Programs on Frailty Status

The present study refers to a three-arm randomized controlled trial that investigated the effects of two types of RT on frailty status, physical performance, cognitive function, and blood pressure of prefrail and frail older adults.


Eligibility Criteria:
Inclusion Criteria:

* a) aged 60 years or over; b) were prefrail or frail according to Fried's criteria; c) performed the sit-to-stand test alone, with a mobility aid, or researcher's help; d) possessed sufficient physical and cognitive abilities to perform exercise sessions; and e) had a physician authorization to participate.

Exclusion Criteria:

* Exclusion criteria included having participated in a structured physical exercise training program in the past six months, prescription of hormone replacement therapy and/or psychotropic drugs, and any unstable cardiovascular event (e.g., myocardial infarction) or complication in the past 6 months.
Adipose Mesenchymal Stem Cells (AMSC) for Treatment of Ulcerative Colitis

Ulcerative colitis is a form of inflammatory bowel disease characterized by diffuse inflammation of the colonic mucosa. It affects the rectum and extends proximally along a variable length of the colon. Ulcerative colitis is a chronic condition with a relapsing remitting course. Mesenchymal stem cells (MSCs) are a subset of adult stem cells residing in many tissues, including bone marrow (BM), adipose tissue, umbilical cord blood. Recent experimental findings have shown the ability of MSCs to home to damaged tissues and to produce paracrine factors with anti-inflammatory properties, potentially resulting in reduction of inflammation and functional recovery of the damaged tissues. The purpose of our study is to evaluate safety and efficacy of the intracolonic injection by using a colonoscope of allogeneic adipose MSCs in patients with moderate active ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18-65 years old
* Diagnosis of ulcerative colitis diagnosed at least 6 months earlier
* Moderate or severe activity defined by a Mayo score
* No serious infection, chronic diseases, diabetes and tuberculosis
* Unefficient by using 5-ASA, glucocorticoid or azathioprine
* Written informed consents were obtained from all subjects
* Capable of good communication with researchers and follow the entire test requirements
* Negative pregnancy test for women of childbearing potential (from menarche to menopause)

Exclusion Criteria:

* Pregnant or breastfeeding women or cognitively impaired adults
* History of malignant disease
* Infectious colitis
* Patients with known allergies to culture medium
* Patients having participated in clinical trials with any investigational drug within 1 month prior to enrolment in this study
* Patients with suspicion of Crohn's enterocolitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated colitis, or microscopic colitis
* Patients with previous colectomy
* Positive to one or more of the infectious disease panel
* Treatment with surgery or biological treatment (infliximab or adamizumab) or Cyclosporine or tacrolimus or mycophenolate in the 8 weeks prior to inclusion in the study
* Presence of severe concomitant diseases
* Patients with clostridium difficult or cytomegalovirus infection
A Comparison of 5 Low Volume Bowel Preparations

The purpose of this investigation is to compare 3 versions of MiraLAX/Gatorade, MoviPrep and SUPREP to see which preparation cleanses the colon best and which preparation is best tolerated.


Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years old planning to undergo an elective colonoscopy will be eligible for inclusion in our study. We would prefer to exclude as few groups as possible since in clinical practice these less well studied groups often need a colonoscopy and will need to have a colonoscopy preparation.

Exclusion Criteria:

1. Patients who are allergic (this is very rare) or intolerant to any of the study drugs.
2. Patients who are pregnant.
3. Patients who required multiple day colon preparations (2 days prior and 1 day prior) in the past will be excluded.
4. Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded.
5. Patients with known renal disease (baseline creatinine greater than 1.50 mg/dl) will need to be excluded due to the magnesium in SUPREP which is contraindicated in patients with significant renal disease.
Application of Transthoracic Shear-wave Ultrasound Elastography in Pleural Lesions

This study aims to provide the information of tissue elasticity in different etiologies of pleural lesions and to validate the predictive value of shear-wave elastography in differentiating benign pleural lesions from malignant lesions.


Eligibility Criteria:
Inclusion Criteria:

* Patients with radiographic evidence of pleural lesions or effusion

Exclusion Criteria:

* Age \< 20 y/o
* Patients who cannot hold their breath for 5 seconds