cyrilzakka/clinical-trials huggingface dataset:
Prescriptive Mobilization Versus a Pragmatic Mobilization

This study is designed to compare the outcomes of two types of manual therapy techniques on patients with low back pain. Both immediate- and long-term outcomes will be examined. The investigators hypothesize there will be no differences between the two applied treatment techniques in immediate and longer-term assessments.

This randomized clinical trial is designed to compare the outcomes of a prescriptively applied non-thrust manipulation to a pragmatically applied non-thrust manipulation on subjects with mechanical low back pain. The study has two primary aims. Specific Aim 1 examines immediate effect differences between a pragmatically applied localized non-thrust manipulation versus a prescriptively applied, non-localized non-thrust manipulation in subjects with mechanical low back pain. Specific Aim 2 examines longer-term differences between a pragmatically applied localized non-thrust manipulation versus a prescriptively applied, non-localized non-thrust manipulation in subjects with mechanical low back pain. The investigators hypothesize there will be no differences between the two applied treatment techniques in immediate and longer-term assessments.

Eligibility Criteria:
Inclusion Criteria:

* Patients will need to be 18 years of age or older with mechanically producible LBP. They will require a minimum Modified Oswestry Disability Index score of 20% and a baseline pain score of \>2.0/10 on the numeric analog scale for pain, and a within session change (improvement during the visit) in pain and/or range of motion during the assessment phase of the clinical examination.

Exclusion Criteria:

* The presence of any red flags (i.e., tumor, metabolic diseases, rheumatoid arthritis, osteoporosis, prolonged history of steroid use, etc.), or signs consistent with nerve root compression (reproduction of low back or leg pain with straight leg raise at less than 45°, muscle weakness involving a major muscle group of the lower extremity, diminished lower extremity muscle stretch reflex, or diminished or absent sensation to pinprick in any lower extremity dermatome). Other exclusion criteria include prior surgery to the lumbar spine and current pregnancy. Lastly, if patients are enrolled in the study but do not receive a second outcome measure (follow up visit) they will be excluded from the final analyses.
Treatment of Breast Fibroadenoma With FastScan HIFU

This study evaluates the efficacy of the HIFU for the treatment of breast fibroadenoma with the FastScan version using assessment of patient experience and adverse event reporting.

Echopulse is specially designed, manufactured and CE marked for treating breast fibroadenoma. HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted area.

In a previous european feasibility study performed at 4 sites (France and Bulgaria), 51 fibroadenomas in 42 patients were treated. The HIFU treatment was well tolerated and showed efficacy (mean volume reduction of 72.5% +/-16.7 at 12 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Female patients 18 years or older with one diagnosed breast fibroadenoma.
* Diagnosis of fibroadenoma must be based on :

  * clinical examination,
  * ultrasound image alone for patients under 35 years old. For women older than 35 years, a mammogram will be performed in addition to ultrasound. The BI-RADS (Breast Imaging, Reporting and Data System) score of this mammogram must be less than 3.
  * histologic confirmation after core needle biopsy by two independent readers (biopsy must be performed at least two weeks before therapy unless a microbiopsy has been already done less than 3 months before inclusion visit and histopathology slices are available).
* The requirements for the distance from the skin and the following regions of the fibroadenoma are:

  * ≤ 23 mm from the posterior border of the fibroadenoma
  * ≥ 5 mm from the anterior border of the fibroadenoma
  * ≥ 11mm from the focal point of the HIFU treatment. These criteria shall be evaluated immediately prior to treatment once breast is immobilized and potentially compressed
* The rib cage should not be in the prefocal ultrasound path or behind the target fibroadenoma (minimum distance behind the focal point= 10 mm). This criterion shall only be reached in treatment conditions, once breast is immobilized and potentially compressed.
* Patient's fibroadenoma is 1 cm or greater at its largest dimension
* Fibroadenoma is palpable
* Patient has signed a written informed consent.

Exclusion Criteria:

* Patient who is pregnant or lactating.
* Patient with a BI-RADS score \> 2 at the mammogram, or presence of microcalcifications within the lesion.
* Patient with history of breast cancer or history
* Patient with history of laser or radiation therapy to the target breast
* Patient with breast implants in the target breast
* Patient with a breast cyst
* Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit
* Patient participating in other trials using drugs or devices.
Effects of Weight Loss From Bariatric Surgery on Intraocular Pressure (IOP)

The purpose of this study is to determine if there is an effect on the eye pressure from extreme weight loss by bariatric procedures. The hypothesis is that excess fat in the orbit of the eye compresses on the outflow system, which causes an elevated eye pressure. This can have many consequences, including the risk for glaucoma. We hope to establish if there is an effect between eye pressure and weight.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Written informed consent obtained
* BMI \> 40 kg/m2 without associated comorbidities or \> 35 kg/m2 with associated comorbidities. In the normal indication for routine bariatric surgery, comorbidities include hypertension, type II diabetes, venous stasis, sleep apnea, polycystic ovary syndrome, pseudotumor cerebri, nonalcoholic steatohepatitis, gastroesophageal reflux disease, coronary artery disease, degenerative joint disease, cancer, and hypercholesterolemia.

Exclusion Criteria:

* Current use of systemic steroids
* Any systemic medication which is unstable and can affect IOP
* History or evidence of glaucoma
* Any ocular trauma or ocular surgery
* Outside normal range of corneal thickness (500-600 microns)
* Unable to follow-up for 3 years
* Participating in any investigational device or medication study within 30 days of baseline
Laser Therapy in Preventing Oral Mucositis in Patients Undergoing Bone Marrow Transplantation

RATIONALE: Laser therapy may reduce the severity of symptoms and speed healing of oral mucositis. It is not yet known if laser therapy is effective in preventing oral mucositis.

PURPOSE: Randomized phase II/III trial to determine the effectiveness of laser therapy in preventing oral mucositis in patients who are undergoing bone marrow transplantation.

OBJECTIVES: I. Determine whether low-energy laser therapy can prevent oral mucositis in patients undergoing bone marrow transplantation.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to one of three treatment arms. Arm I: Patients undergo low-energy laser therapy with visible red light (650 nm) daily over 15-20 minutes beginning on the first day of their transplant conditioning regimen and continuing until day 2 after bone marrow transplantation. Arm II: Patients undergo low-energy laser therapy with invisible infra-red light (780 nm) daily on the same schedule as in arm I. Arm III: Patients undergo sham laser therapy daily on the same schedule as in arm I. Patients are followed on days 3, 7, 10, 14, 18, 21, and 24.

PROJECTED ACCRUAL: A total of 66 patients (22 per treatment arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: At risk of developing oral mucositis due to toxicity resulting from one of the following: Preparative chemoradiotherapy Multiple drug conditioning regimens Graft-versus-host disease (GVHD) prophylaxis

PATIENT CHARACTERISTICS: Age: Over 12 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Able to carry out routine oral care No active oral, viral, bacterial, or fungal infections No active uncontrolled oral bleeding that would preclude laser therapy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: Not currently enrolled on other protocols with oral mucositis as a stated end point (e.g., conditioning regimen toxicity trials or GVHD prophylaxis trials) No other concurrent investigational drugs or agents for the prevention or treatment of mucositis No concurrent photosensitizing agents
A Study of Clofarabine in Older Patients With Acute Myeloid Leukemia (AML) for Whom Chemotherapy Is Not Suitable

The purpose of the study is to determine if treatment of older patients indicated with untreated Acute Myeloid Leukemia (AML) who are not considered to be suitable for intensive chemotherapy, can effectively be treated with Clofarabine.

Note: This clinical trial was conducted by Bioenvision Ltd. Bioenvision Ltd. was acquired by Genzyme Corporation Oct 2007.

Eligibility Criteria:
Inclusion Criteria:

* Provide signed, written informed consent
* Have untreated AML according to World Health Organization (WHO) classification
* Male or post-menopausal female ≥ 65 years of age
* Unsuitable for intensive chemotherapy
* Be able to comply with study procedures and follow-up examination
* Male patient who are fertile agree to use and effective barrier method of birth control to avoid pregnancies
* Have adequate liver and renal function as indicated by certain laboratory values

Exclusion Criteria:

* Received previous treatment with clofarabine
* Are receiving other chemotherapy or corticosteroids (low-dose corticosteroid for pre-medication purposes are allowed)
* Have received prior treatment for leukemia. Growth factor, cytokine support, leukopheresis or hydroxyurea will be allowed but must be discontinued at least 24 hours prior to start of treatment with clofarabine
* Have a psychiatric disorder that would interfere with consent, study participation, or follow-up
* Have an active, uncontrolled systemic infection
* Are currently participating in other investigational drug studies or having received other investigational drugs within the previous 30 days
* Have symptomatic central nervous system (CNS) involvement
* Blast transformation of chronic myeloid leukemia or acute promyelocytic leukemia
A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Advanced NSCLC With Leptomeningeal Metastasis

To observe the efficacy of Trilaciclib combined with lateral ventricular chemotherapy in the treatment of non-small cell lung cancer with leptomeningeal metastasis。

A single-arm, open-label, interventional study was conducted in 25 NSCLC patients with leptomeningeal metastases to observe the efficacy of Trilaciclib combined with lateral ventricular chemotherapy in the treatment of non-small cell lung cancer with leptomeningeal metastases, and to evaluate the incidence and duration of severe neutropenia in the first cycle.

Eligibility Criteria:
Inclusion Criteria:

* must be at least 18 years when fisrt dose of Trilaciclib, regardless of gender；
* ECOG-PS score of 0-1，and no worsening in the 2 weeks before the study drug；
* expected survival≥12 weeks；
* Advanced non-small cell lung cancer with leptomeningeal metastasis；
* with an Ommaya sac has been implanted；
* At least one measurable lesion meeting RECIST1.1 criteria was present；
* Laboratory tests met the following criteria: hemoglobin ≥100 g/L (female), 110g/L (male) ；neutrophil count ≥ 2×109/L ；platelet count ≥100×109/L; Creatinine ≤ 15mg/L or creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula); Total bilirubin ≤ 1.5× upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN or 5× ULN (for patients with liver metastases); Albumin ≥ 30 g/L;
* Patients of reproductive age(including female and male patients'female companions)must use effective birth control measures;
* Voluntarily participate and sign informed consent;

Exclusion Criteria:

* Patients of reproductive age(including female and male patients'female companions)must use effective birth control measures;
* Stroke or cardio-cerebrovascular event within 6 months before enrollment;
* QTcF interval \> 480msec at screening, QTcF \> 500msec for patients with implanted ventricular pacemakers;
* Previous hematopoietic stem cell or bone marrow transplantation;
* Allergy to the study drug or its components;
* If the investigator considers that it is not suitable to participate in this study.
Study of Brentuximab Vedotin Combined With RCHOP or RCHP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL)

This study has 3 parts. The purpose of Part 1 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) (known as BV+RCHOP) in patients with DLBCL who have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive RCHOP together with 1 of 2 doses of brentuximab vedotin. Patients will be tested to see if there is a difference in side effects between the 2 groups.

The purpose of Part 2 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) (known as BV+RCHP) in patients with CD30-positive DLBCL who have never been treated. Patients will be enrolled to receive RCHP together with 1.8mg/kg of brentuximab vedotin.

The purpose of Part 3 of this study is to assess the safety and efficacy of BV+RCHP compared to standard RCHOP in patients with CD30-positive DLBCL that have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive either BV+RCHP or RCHOP. Patients will be tested to see if there is a difference in side effects between the 2 groups.

In the first part of this study, patients in the 2 groups were tested to see if there was a difference in the response to treatment and whether there were differences in the side effects (unwanted effects).

The second and third parts of the study are being done to see if there are any side effects (unwanted effects) of the higher dose of brentuximab vedotin when combined with a modified version of RCHOP that omits vincristine. The third part of the study is being done to see if there is a difference between BV+RCHP and RCHOP in the response to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Treatment-naive patients with systemic de novo or transformed diffuse large B cell lymphoma (DLBCL) or follicular non-Hodgkin lymphoma (NHL) grade 3b
* International Prognostic Index (IPI) score greater than or equal to 3 for patients greater than 60 years of age or age-adjusted IPI (aaIPI) score of 2 or 3 for patients less than or equal to 60 years of age
* Stage IAX (bulk defined as single lymph node mass \>10 cm in diameter), IB-IV disease
* Measurable disease of at least 1.5 cm
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
* Patients in Parts 2 and 3 must have histologically confirmed diagnosis of CD30-positive DLBCL

Exclusion Criteria:

* Previous history of treated indolent lymphoma
* History of another primary malignancy that has not been in remission for 3 years
Pilates Mat Exercises Training on Functional Performance in Middle Age Obese Women

• Aim of the study: This study will aim to investigate the effects of a 12-week Pilates-mat exercise program on the functional performance in middle age obese women.

Materials and Methods:

sixty obese women patients (ages 45-55 years old) with a body mass index (BMI) 30 -34.9 kg/m2.Women will be randomly assigned into experimental group(Pilates) or control group, (3 times/week, 60 min/session) their age from 45 to 55 yrs. The Pilates exercises were performed on mats. The functional performance on one-leg stance (OLS), five-times-sit-to-stand (STS) and 6-min walk (6 MW) tests was evaluated before and after the 12-week Pilates training or control follow-up period.

One of the major public health challenges of the 21st century is obesity. In simple terms, obesity is an excessive increase in fat mass. Since the 1980s, its prevalence has tripled in many countries and the population with weight excess continues to grow at an alarming rate. Obesity impacts on morbidity, disability, activities of daily living and increases the risk of developing cardiovascular disease. (Ghiotto et.al 2022). In addition, Obesity is associated with a risk of decrease in functional capacity and muscle strength. (Lakhdar et. al 2023).

Pilates exercises consist of stretching and endurance movements performed within the range of joint motions at a regulated pace with concentration and deep breathing. This workout is a novel approach to physical training that involves a combination of strength, stretching, and respiratory and muscular motions. It aims to build muscle, enhance cardiac and respiratory indices, and promote weight loss. In contrast to conventional resistance exercises, in which individual muscle groups are trained, Pilates exercises require the activation and coordination of several muscle groups. (Hushmandi et .al 2023).

Eligibility Criteria:
Inclusion Criteria:

* women

  * BMI between 30 to 34.9 kg/m2
  * Age will range from 45-55 years old.

    1. Exclusion criteria

Exclusion Criteria:

* Cardiac diseases

  * Liver diseases
  * Hypertension
  * Musculoskeletal disease
Effects of Antagonizing the Ghrelin Receptor on Brain Food Cue Reactivity in Obesity

The naturally occurring peptide hormone liver-expressed antimicrobial peptide 2 (LEAP2) in an antagonist/inverse agonist towards the ghrelin receptor. Ghrelin administration has previously been shown to increase food cue reactivity in brain regions related to appetite and reward using functional MRI scans.

The aim of this clinical study is to investigate the effects of LEAP2 infusion on food cue reactivity in brain regions related to appetite and reward. Since LEAP2 is an antagonist/inverse agonist towards the ghrelin receptor we hypothesize, that LEAP2 infusion will decrease food cue reactivity in the above-mentioned regions compared to placebo infusion.

Participants with obesity (BMI 30-50 kg/m2) will be included and complete two experimental days with either LEAP2 or placebo infusion in a randomized crossover manner. On experimental days, participants will undergo a MRI scan with functional and anatomical modalities.

The study will attribute to gain a deeper understanding of the ghrelin system and its interaction with appetite regulation.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60 years at the time of inclusion
* Body mass index 30-50 kg/m2
* Men
* Informed consent

Exclusion Criteria:

* Anaemia (haemoglobin below normal range)
* Alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) \>2 times normal values) or present hepatobiliary and/or gastrointestinal disorder(s)
* Nephropathy (serum creatinine above normal range and/or albuminuria)
* Glycated haemoglobin (HbA1c) ≥48 mmol/mol and/or type 2 diabetes requiring medical treatment
* Regular tobacco smoking or use of other nicotine-containing products
* Claustrophobia
* Any ongoing medication that the investigator evaluates would interfere with trial participation.
* Any physical or psychological condition that the investigator evaluates would interfere with trial participation including any acute or chronic illnesses
Comparative Study of 22 and 25 Gauge ProCore EUS-guided Biopsy in Pancreatic Mass

Background:

EUS-guided fine needle aspiration (FNA) is a major diagnostic tool in the patient with pancreatic mass with high specificity, specificity and accuracy. However FNA with small needle has sometimes failed in acquisition of tissue due to small caliber. To overcome this limitation, newly designed ProCore needle was developed and flexible 22 and 25 gauge ProCore needles were frequently used. However there was no comparative study of the efficacy and accuracy between 22 and 25 gauge ProCore needle yet.

Aim:

To compare the efficacy and accuracy of EUS-guided FNA between 22 and 25 gauge ProCore needle. (The investigators hypothesized that the accuracy of 25 gauge Procore needle is not inferior to 22 gauge ProCore needle.)

Patient and methods:

Patients who have pancreatic or peripancreatic mass in imaging studies which need pathologic confirm. These patients were randomly assigned to 22 gauge or 25 gauge group.

Procedure:

They underwent EUS-guided FNA, 3 times with 10 times of to-and pro movement each.

The number of patients required:

We used confidence intervals (CIs) with a prespecified non-inferiority margin of 10% for the non-inferiority analysis. We concluded non-inferiority of PC25 to PC22 if the lower limit of the 95% CI for the difference (PC25-PC22) was not lower than -10%. It was assumed that the diagnostic accuracy of one pass was 75% and that of three cumulative passes was estimated to be 98.4% in PC22. Based on these assumptions, the calculated sample size was 216 samples with power of 80% and significance level of 5%.

Eligibility Criteria:
Inclusion Criteria:

* Patients who agree to participate in research
* 18 years of age and older patients
* Patients who have pancreatic or peripancreatic mass in imaging studies

Exclusion Criteria:

* Contraindication to endoscopy
* Patients younger than 18 years old
* Bleeding tendency
* Cardiopulmonary dysfunction