cyrilzakka/clinical-trials huggingface dataset:
The Gut Microbiome in FLT3- AL Undergoing Allo-HSCT With Or Without Sorafenib Maintenance

This prospective trial investigates the effect of sorafenib maintenance therapy in FLT3 negative acute leukemia patients after allo-HSCT in terms of gut microbiome.

Acute leukemia is a heterogeneous group of clonal diseases. Leukemia relapse remains the main cause of treatment failure, including the patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). Sorafenib, an inhibitor of multiple kinases including FLT3, has shown promising activity in FLT3-ITD-positive AML. The investigator's previous studies demonstrated that sorafenib maintenance post-transplantation could improve the outcomes of FLT3-ITD positive AML patients, which was associated with sorafenib enhancing the graft-versus-leukemia (GVL) effect. Recent studies have shown that sorafenib is also effective in patients with FLT3-negative acute leukemia. The investigator's previous exploratory study found that salvage therapy such as sorafenib combined with chemotherapy and donor lymphocyte infusion could significantly improve the CR rate and survival in patients with recurrent FLT3-negative acute leukemia after allo-HSC. More and more studies have shown that sorafenib and allo-HSCT have synergistic GVL effect. Some studies have demonstrated that gut microbiome is associated with graft-versus-host-disease (GVHD) and GVL. However, the exact mechanism of sorafenib enhancing the GVL effect and the influence of gut microbiome on sorafenib maintenance after allo-HSCT in FLT3 negative acute leukemia patients remain unknown.

Eligibility Criteria:
Inclusion Criteria:

* FLT3 Negative Acute Leukemia
* Allo-HSCT Recipients

Exclusion Criteria:

* intolerance to sorafenib pretransplantation
* cardiac dysfunction (particularly congestive heart failure)
* hepatic abnormalities (bilirubin ≥ 3 mg/dL, aminotransferase\> 2 times the upper limit of normal)
* renal dysfunction (creatinine clearance rate \< 30 mL/min)
* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (according to the investigators' decision)
Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions

This study is to retrospective investigate the effects of the simultaneous intravenous (i.v.) administration of lidocaine and ketamine on a four to six weeks interval in treatment refractory different chronic pain conditions.

The use of intravenous infusion therapy with lidocaine or ketamine has been of interest in several chronic pain conditions. Studies showed a benefit in immediate pain reduction and even longer lasting pain relief for treatment approaches with lidocaine and ketamine.

While there is a broad database on the use of lidocaine and ketamine in chronic pain management as separate agents, very few pre-clinical animal studies have investigated the combined use of said analgesics and none of them reports their combined use in chronic pain patients.

This study is to retrospective investigate the effects of the simultaneous i.v. administration of lidocaine and ketamine on a four to six weeks interval in treatment refractory different chronic pain conditions.

Eligibility Criteria:
Inclusion Criteria:

* ICD11 Medical diagnosis of chronic pain and its subcategories
* Treatment with intravenous lidocaine and ketamine infusions during the years of 2012 to May 2021 at our pain unit at the USB
* Patient is at least 18 years of age at the beginning of the first infusion treatment

Exclusion Criteria:

* Patient is underage at the beginning of the first infusion treatment
* Documented written refusal of consent for research (general consent or specific study consent)
* Patients undergoing treatment with only lidocaine or ketamine respective
Free Gingival Graft Adjunct With Low Level Laser Therapy

The present placebo-controlled parallel design clinical study was planned to determine the effect of low level laser therapy on clinical periodontal conditions and dimensions of free gingival graft as well as postoperative pain levels in the surgical area.

Background: Shrinkage of the free gingival graft (FGG) and patient's discomfort during healing period are important concerns. Therefore, this study aimed to evaluate the effect of low level laser therapy (LLLT) in terms of enhancing wound healing, reducing graft shrinkage and postoperative pain.

Methods: Thirty patients were randomly assigned to receive either FGG+ LLLT (test, n = 15) or FGG + placebo LLLT (control, n = 15). In the test group, a diode laser (aluminum-gallium-arsenide, 810 nm, 0.1 W, continuous mode, time of irradiation:60 s, energy density: 6 J/cm2, spot size:0.5 cm) was applied immediately after the FGG surgery and 1,3,7, and 14 days later. The control group received the same sequence of irradiation with the laser-off. Comparison of the graft surface areas between groups at 1st, 3rd and 6th months were made with an image-analyzing software. Complete wound epithelization, visual analogue scale (VAS) pain score of recipient site and the number of analgesic used were evaluated after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years old
* Patients presenting Class I or II Miller gingival recession on vital incisors in the mandibular anterior region with no caries or restoration
* The included teeth had also keratinized gingiva \<2 mm; PI and GI\<1.
* The patients had to be systemically healthy and non-smokers.

Exclusion Criteria:

* Patients presenting active periodontal disease and probing depth \>3 mm; taking medications that would interfere with the wound-healing process or that contraindicate the surgical procedure;
* Pregnant or lactating women;
* Patients who underwent periodontal surgery in the study area;
* Patients with orthodontic therapy in progress were excluded.
Running Related Injury Among Novice Runners

About 31% of the Danish population participates regularly in running. The positive health benefits of running have been well documented in the literature. Unfortunately, running has been connected with a high risk of injuries.

Running related injuries can cause a long rehabilitation and may even force the runner to quit running permanently. To ensure that running can be practiced as a safe exercise activity prevention must be considered.

Training errors (i.e. excessive volume, sudden change of training routines etc.) are held to be the main reasons to running related injuries. Fortunately, training errors can be avoided as training characteristics (distance, duration, pace) can be controlled by the runner.

In order to avoiding training errors, especially excessive volume many novice runners follow 0-5 kilometres type training programmes. However, limited research has been conducted on the training volume of beginner programs and the risk of running related injuries.

The purpose of this study is to investigate the relationship between the running volume the first 4 weeks of a running regime and the risk of running related injuries among novice runners. The relationship between running volume and running related injuries will be investigated in proportion to their body mass index (BMI).

Eligibility Criteria:
Inclusion Criteria:

* both gender between 16-65 years
* no running-training within the last year
* less than 20 hours of sports activity within the last year (in total)
* internet access and mail address
* body mass index between 18.5 - 25 or 30-35
* owns a pair of running shoes

Exclusion Criteria:

* do not want to use a GPS watch
* unable or unwilling to follow the running regime in 4 consecutive weeks
* previous injury in lower extremity within the last 2 years
* unable to read or understand Danish
* former heart surgery
* known heart surgery
* known lung disease
* diabetes
* current pregnancy
* known tendency to shortness of breath or chest pain with activity
* known tendency to leg pain when walking long distances
Apixaban Dose Reduction in Patients With Elevated Drug Levels

Apixaban is an anticoagulant which is increasingly being used to prevent stroke in atrial fibrillation (AF). Phase III clinical trials have demonstrated that apixaban is efficacious and safe for the overall AF population; however, patients older than age 85, with creatinine clearance \<40mL/min, or who weighed \<50kg were poorly represented in these trials, yet they are commonly seen in real-world clinical scenarios. Advanced age, poor renal function, and low body weight are all associated with elevated drug levels, and elevated drug levels are associated with an increased risk of bleeding. Therefore, clinicians are concerned about the risk of bleeding and are unsure of how best to treat this patient population. Although other anticoagulants are available, apixaban is attractive because it has a low rate of bleeding, low dependence on the kidneys for clearance, and does not require frequent ongoing monitoring and dose adjustment. This study will include patients taking apixaban who were not well-represented in phase III trials - those with age \>85, creatinine clearance \<40mL/min, or weight \<50kg - who are also at increased risk of having elevated drug levels due to these clinical characteristics. Participants will have apixaban levels measured, and those with persistently elevated levels will have their dose reduced. Drug levels will be measured again after dose reduction to determine if the levels are reduced without becoming dangerously low.


Eligibility Criteria:
Inclusion Criteria:

* Patients with non-valvular atrial fibrillation (permanent, paroxysmal, or persistent) receiving apixaban with any of the following characteristics: age\>85; creatinine clearance \<40mL/min; or body weight \<50kg.

Exclusion Criteria:

* Inability to visit Hamilton General Hospital;
* Inability or unwillingness to provide written informed consent.
* Stroke or thromboembolic event in the past 6 months.
The Effect of Education Given to Individuals With Hypertension by Mobile Phone

This study was planned as randomized controlled trial in order to evaluate the effect of the mobile education given to the individuals with hypertension on DASH diet compliance, healthy lifestyle behaviours, quality of life, mindfulness and stress levels.

The study was conducted as a randomized controlled trial with 134 individuals with hypertension (68 experimental, 66 controlled) who applied a university hospital in Edirne between the dates on 20.01.2022 and 18.05.2023. The data were collected by "Patient Information Form", "Healthy Lifestyle Behaviour Scale II", "EQ-5D General Quality of Life Scale", "Mindful Attention Awareness Scale" and "Percieved Stress Scale" were used. An education application was installed on the mobile phones of the experimental group. Individuals with hypertension were provided with a training for three months through the mobile application. Data collection forms were filled in by the individuals with hypertension in the experimental and controlled groups at the beginning and at the 3rd month via the mobile application. The data were analyzed in SPSS 26 (Statistical Package for the Social Sciences) program with the Shapiro-Wilk test, Student's t-test, Paired-Sample t-test, Chi-Square test, Fisher's Exact test, Fisher-Freeman-Halton test and Pearson correlation coefficient. The results were evaluated at % 95 confidence interval and the significance was evaluated at p\<0,05 level.


Eligibility Criteria:
Inclusion Criteria:

* Those diagnosed with Primary Hypertension (at least 1 month ago),
* Over 18 years,
* No communication barriers,
* Being literate,
* Volunteering to participate in the research,
* Individuals with hypertension who own a smartphone.

Exclusion Criteria:

* under 18 years old,
* Having a communication barrier,
* Those with chronic kidney disease,
* Individuals with hypertension and heart failure.
The Safety and Feasibility of Costal Bone Marrow Aspiration During Thoracic Surgery

This pilot trial is designed to evaluate the feasibility and safety of obtaining bone marrow from costal aspiration during surgery.

The investigators hypothese that sufficient bone marrow-derived HSPC's (which represent only 0,1% of the total bone marrow fraction) can be derived by rib bone marrow aspiration for ex vivo single-cell evaluation, optimization of a 3D BMN platform and preclinical ex/in vivo assessment in patient-derived organoids and murine xenograft models.

This pilot trial is designed to evaluate the feasibility and safety of obtaining bone marrow from costal aspiration during surgery.

Previous trials demonstrated the feasibility of micro-metastasis detection in rib marrow aspirate. This procedure appears safe since no adverse events were documented during previous trials. The investigators hypothesize this technique can be used to obtain sufficient bone marrow-derived HSPC's (which represent only 0,1% of the total bone marrow fraction) for ex vivo single-cell evaluation, optimization of a 3D BMN platform and preclinical ex/in vivo assessment in patient-derived organoids and murine xenograft models. The use of rib marrow eliminates the need for extra incisions because the cuts made for trocar placement or the thoracotomy can be re-used. Therefore, the investigators hypothesize that the patients undergoing costal bone marrow aspiration during surgery will not experience extra discomfort. Every patient undergoing thoracic surgery is treated according to ERAS protocols with a major emphasis on pain control.

If the feasibility and safety of bone marrow aspiration are confirmed by this pilot trial, the investigators plan to conduct a large-scale study in which they will collect and bank blood, bone marrow and tumor per NSCLC patient. With this unique autologous biological material collection, the investigators aspire to conduct innovative research into the current resistance mechanisms of NSCLC to immunotherapy;

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing thoracic surgery for a confirmed or suspected lung cancer

Exclusion Criteria:

* Uncertainty of pre-operative diagnosis, exception is per-op frozen section analysis confirming malignity
* ASA ≥ 3
* Bleeding disorders
Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis

To determine the clinical safety and efficacy of abaloparatide transdermal in otherwise healthy postmenopausal women with osteoporosis as assessed by changes in bone mineral density (BMD) and serum markers of bone metabolism when compared to transdermal placebo and abaloparatide injection for 6 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal woman, less than 85 years old.
* BMD T-score ≤-2.5 of spine or hip (femoral neck) or ≤-2.0 with previous fracture (within 5 years).
* Normal physical exam, vital signs, electrocardiogram (ECG), and medical history.
* Laboratory tests within the normal range, including serum calcium, Vitamin D, parathyroid hormone (PTH) (1-84), serum phosphorus, and alkaline phosphatase.

Exclusion Criteria:

* BMD T-score ≤-5.0 at the lumbar spine or hip.
* History of bone disorders (for example, Paget's disease) other than postmenopausal osteoporosis.
* Significantly impaired renal function.
* History of any cancer.
To Demonstrate the Relative Bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fasted Conditions

To demonstrate the relative bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride capsules under fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Comparison of Hybrid and Laparoscopic Incisional Hernia Repair

Study is a prospective, multicenter, randomized trial evaluating two laparoscopic incisional hernia repair methods: basic laparoscopic mesh repair (lap.) and a hybrid repair (laparoscopic mesh and fascial suturation).

Patients are recruited prospectively from 10 Finnish Hospitals (Oulu, Jorvi, Hyvinkää, Kotka, Seinäjoki, Valkeakoski, Lahti, Kuopio, Kokkola, Loimaa).

Patients are randomized to operative groups (lap. vs hybrid).

Follow-up visits are scheduled at 1- and 12-month after surgery. Patients are evaluated for their clinical status and an ultrasound scan is performed. QoL-questionnaire and pain score (VAS) are reported.

The primary end-points:

* clinically and/or radiologically detected seroma in 1 month control
* clinically and/or radiologically detected recurrent hernia in 1 year control

The secondary end-points:

* peri-and postoperative outcomes/ complications, morbidity, mortality
* duration of hospital stay
* pain scale (VAS)
* Quality of Life (SF/Rand36)

Hypothesis: Using a hybrid method seroma formation and hernia recurrence can be diminished.

Patient exclusion criteria:

Age\< 18 y or \> 80 y ASA \>4 (the American Society of Anaesthesiologists' classification of Physical Health) BMI\> 40 A previous mesh repair of the hernia Hernia defect size \<2 or \>7 cm Emergency operation

Eligible patients are randomized into two operative groups (lap/hybrid). In the laparoscopic group the hernia defect is covered with a Parietex composite mesh (using minimum of 5 cm marginals, Securestrap fixation instrument and four lifting strings. In hybrid group the hernia sack is resected and fascial defect is sutured through a minilaparotomy incision. After this, a mesh repair is performed laparoscopically.

Eligibility Criteria:
Inclusion Criteria:

-Patients with incisional hernia

Exclusion Criteria:

* BMI \>40
* ASA IV
* a Prior mesh repair
* Hernia defect size \<2 or \>7 cm
* Emergency operation
Study to Assess Acute Vasodilation Response of Inhaled Nitric Oxide

The EAGLE study is a Phase 3, open-label, multi-center, two-part, single-arm study of GeNOsyl(R) delivery system(s) to evaluate if inhaled nitric oxide-induced vasodilation predicts successful wean from parenteral prostacyclin (PGI) in subjects with World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) undergoing a medically necessary right heart catheterization (RHC). All subjects enrolled in the study will undergo an attempt to wean from parenteral PGI per standard of care.

This study will be divided into 2 parts: a Pilot Phase followed by Pivotal Phase.

* The Pilot Phase will enroll up to 20 subjects. The information derived from the Pilot Phase will evaluate safety, and assess the vasoreactivity test response rate.
* Approximately 150 subjects will be enrolled in the Pivotal Phase of the study, to gather further data on weaned successes from parenteral PGI. The Investigator and study staff involved with the wean and patient management will be blinded in this phase of the study to the vasoreactivity results.

Eligibility Criteria:
Inclusion Criteria:

* The subject or subject's legally authorized representative signs and dates an Institutional Review Board (IRB) approved informed consent form prior to the initiation of any study-related activities.
* The subject has been diagnosed with PAH (WHO Group 1) and is WHO Functional Class I or II at Screening.
* The subject has documented continuous PGI use for ≥ 1 year from Screening, without a significant interruption (i.e., ≤ 2 day interruption) and without a failed complete wean attempt.
* The subject is a candidate for weaning off parenteral PGI therapy (per Investigator judgment and standard of care).

Exclusion Criteria

* The subject has a hypersensitivity or allergy to ingredients of inhaled nitric oxide or other clinically significant allergies (clinical significance per Investigator judgment).
* The subject has a PCWP or left ventricular end diastolic pressure (LVEDP) ≥15 mmHg at Baseline.
* The subject has participated in an investigational product or device study within the 30 days prior to Screening.
Use of Fluorescein Dye for the Removal of Brain Tumors

Fluorescein is a dye agent that can be injected through an intravenous line. It has been shown to help tell the difference between brain tumor tissue and normal brain tissue when it is used together with a specialized filter on a microscope in the operating room. The investigators plan to study the use of fluorescein in the removal of brain tumors at a low dose.


Eligibility Criteria:
Inclusion Criteria:

1. Age of 18 or greater
2. Plan for elective removal of a brain tumor at UPMC Shadyside with either Dr. Engh or Dr. Amankulor.

Exclusion Criteria:

1. History of adverse reaction to fluorescein.
2. Emergent surgical procedure (consent not feasible).
3. Creatinine of \> 2.0 (drug is excreted renally).
4. Known ongoing pregnancy.
Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in Newly Diagnosed ETP-ALL

ETP-ALL is a subtype of T-cell acute lymphoblastic leukemia (T-ALL) with poor outcomes and prognosis. Effective induction therapy is crucial in improving the treatment effect. Based on our laboratory research and clinical practice, the venetoclax plus HAG regimen shows promising efficacy in treating ETP-ALL. Therefore, we plan to conduct a prospective, multicenter Phase III clinical study to evaluate the efficacy of the venetoclax plus HAG regimen in treating newly diagnosed ETP-ALL patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥14 and \<75 years old.
* Diagnosed with ETP-ALL (including near-ETP ALL) before enrollment.
* Newly diagnosed patients.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Expected survival of ≥3 months.
* Able to undergo oral treatment with venetoclax.
* No organ dysfunction that would restrict the treatment administered
* Understanding of the study and signing of the informed consent form.
* Men, women of childbearing potential (postmenopausal women must have been amenorrheic for at least 12 months to be considered infertile), and their partners must voluntarily use effective contraception methods as deemed appropriate by the investigator during the treatment period and for at least 12 months after the last dose of the study drug.

Exclusion Criteria:

* Patients who are unable to take venetoclax by mouth;
* Patients with severe heart, lung, liver, kidney, or other organ dysfunction that may restrict their participation in this trial due to diseases;
* Evidence of other clinically significant uncontrolled condition(s) such as uncontrolled and/or active systemic infection (viral, bacterial or fungal)
* A history of other malignant tumors within the past 5 years, excluding localized thyroid cancer and in situ skin cancer;
* Serum total bilirubin \>1.5 ULN (upper limit of normal) (excluding leukemia infiltration); ALT or AST or ALP \>5 ULN; serum creatinine \>1.5 ULN and creatinine clearance rate \<40 mL/min; LVEF \<50%;
* Known HIV infection;
* Known central nervous system leukemia infiltration;
* Gastrointestinal diseases known to affect venetoclax absorption as judged by the investigator;
* Inability to understand or comply with the study protocol.