cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of the Pilates Method Versus Aerobic Exercises in Elderly With Low Back Pain

Chronic low back pain is potentially disabling for the elderly, and physical exercises are considered the best treatment for this problem. The Pilates method has been proven effective in the improvement of pain and function in patients with low back pain. However, the evidence about the effectiveness of Pilates method in the treatment of elderly patients with low back pain is scarce. Thus, the aim of this study is to investigate the effectiveness of the Pilates method compared to aerobic exercise in elderly with chronic non-specific low back pain. This randomized controlled trial with two arms and blinded assessor will include 74 patients aged between 65 and 85 years, of both sexes, complaining of chronic non-specific low back pain persisting for more than three months and pain intensity greater than 3 points in the Pain Numerical Rating Scale. The elderly will be randomized into two groups: Pilates Group (n = 37) with exercises based on Pilates method; and Aerobic Group (n = 37) with aerobic exercises, stretching and relaxation. Both groups will hold treatment twice a week with duration of 60 minutes for eight weeks. The primary outcomes will be: pain intensity and general disability assessed eight weeks after randomization. Secondary outcomes will be: pain intensity and general disability evaluated six months after randomization; global impression of improvement, specific disability and dynamic balance, muscle strength of the gluteus maximus, gluteus medius and lateral hip rotators and pressure pain threshold evaluated eight weeks and six months after randomization. We expect that the results of this study contribute to the clinical decision-making with respect to pain reduction and, consequently, improving balance and functionality of elderly with chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Elderly complaining of non-specific low back pain for more than three months
* Pain intensity equal to or more than 3 points evaluated by the Pain Numerical Rating Scale in the last seven days.

Exclusion Criteria:

* Contraindication to physical exercise;
* Back with severe disease (fractures, tumors, inflammatory diseases, ankylosing spondylitis and nerve root compromise confirmed by neurological tests);
* Previous or scheduled back surgery ;
* Severe cardiorespiratory disease;
* Cancer;
* Cognitive impairment;
* Dependent gait;
* Patients who underwent physical therapy for low back pain in the last six months;
* Regular physical activity practitioners.
Genetic Abnormalities and Oxidative Stress in Sperm as Cause of Recurrent Miscarriage.

In recurrent miscarriage, the male factor has been poorly evaluated. In fact, in the vast majority of clinical protocols of recurrent miscarriage, the sperm is not considered or assessed. Recently, some studies have suggested the presence of genetic and metabolic sperm anomalies in couples suffering from repeated miscarriages. Specifically, DNA fragmentation and altered oxidative stress in the sperm and Y microdeletions from blood samples have been related to an increased risk of miscarriage.The aim of the present study is to compare these three parameters in: couples with recurrent miscarriage; oligozoospermic men with or without recurrent miscarriages; and healthy sperm donors, in order to determine their actual impact on this reproductive problem.


Eligibility Criteria:
Inclusion Criteria:

4 groups

* Recurrent miscarriage, \<40 year-old-men, \< 38 year-old-women, normal or mild affected sperm, normal parents karyotype, no thrombophilia, normal uterus, no endocrinopathy
* The same criteria than in group A, but oligozoospermia (1-5 mill/ml)
* Oligozoospermia (1-5 mill/ml), \< 40 year-old-men, no recurrent miscarriages
* Healthy young sperm donors
Study of Tomotherapy HD in Medulloblastoma

The aim of the study was to improve local control and long-term survival in children with medulloblastoma, reduce the side effects of treatment and improve quality of life.

The technical advantages of Tomotherapy HD in the radiotherapy of children medulloblastoma (advantages in clinical operation and physics) were transformed into clinical advantages, and the possible mechanisms were explored.

Eligibility Criteria:
Inclusion Criteria:

* The patient was diagnosed as myeloblastoma by surgical pathology with definite pathological classification. MRI of the head and spinal cord before and after operation, with definite staging; Radiotherapy was performed within 28 days after surgery.

Exclusion Criteria:

* Previous radiotherapy in the whole brain, whole spinal cord or primary focus; Postoperative radiotherapy for more than 28 days.
TC-325 (HEMOSPRAY™) VS. CURRENT STANDARD OF CARE IN MANAGING MALIGNANT GASTROINTESTINAL BLEEDING: A PILOT STUDY TO INFORM A RANDOMIZED CONTROLLED TRIAL.

Introduction: Gastrointestinal (GI) bleeding arising from malignant tumors is increasingly recognized as a result of oncological advances and improved detection methods, and stems from local vessel damage and tumor invasion with associated derangements in the hemostatic system(1, 2). Although conventional endoscopic hemostasis methods improve outcomes in UGIB due to peptic ulcers and other non-variceal benign bleeding lesions of the upper, and perhaps the lower GI tract, data on their use in hemorrhagic, upper or lower gastrointestinal neoplasms are scarce and associated with varying success in initial hemostasis and high rebleeding rates(3-7). Other recognized single or multimodality treatment approaches include radiation therapy, interventional angiography, and surgery. All exhibit disappointing rebleeding rates, and in the case of emergency surgery, high mortality(4, 8-11). Challenges associated with bleeding tumors include hematological derangements such as thrombocytopenia, disseminated intravascular coagulation, and neutropenia, as well as the endoscopic manipulation of friable, diffusely bleeding surfaces when attempting hemostasis(2, 12, 13). The recent advent of TC-325 (HemosprayTM) to Canada, Europe and Asia - referred henceforth as TC-325 - may provide a highly adapted novel endoscopic hemostatic therapeutic alternative for this refractory clinical entity, with promising uncontrolled observations having just been published by our group(13) and others(14). More robust controlled evaluative data are now needed. We propose to study the use of TC-325 in upper and lower malignant GI bleeding compared to contemporary standard of care, and more specifically seeks funding for a pilot study to inform a subsequent peer-review application for a larger, more definitive randomized clinical trial (RCT).


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* able to comprehend the trial and provide written informed consent in French or English, or a close relative with power of attorney
* Patients who present with an upper or lower GI bleeding with a known luminal GI malignancy diagnosed within the past two years will be considered for enrolment. Endoscopic confirmation of an active GI bleed arising from a malignant tumor will be required for final inclusion
* Rebleeding in patients who presented with acute GIB with initial endoscopy suggesting a malignant source based on endoscopic appearance who have not been treated previously with TC-325 will also be included

Exclusion Criteria:

* Refused by patient
* Pregnancy
* Bleeding from non-malignant GI sources such as gastritis/duodenitis, Mallory Weiss syndrome, peptic ulcer disease, varices, vascular malformations, radiation proctitis, polyps, hemorrhoids, and diverticulosis
Pilot Study on Mixed Nuts and Food Intake

The objectives of this study are 1) to determine if consumption of mixed nuts influences food intake and choice, and 2) to determine how personality traits affect food choice, including mood, stress, tendency to seek approval, tendency toward food cravings, and approach to food intake control.

The condition of being overweight or obese has skyrocketed in recent decades, bringing with it many secondary health problems. Therefore, it is important to seek strategies to promote weight loss and to assist in weight maintenance after weight loss. Different diet compositions may have different effects on satiety and thus affect food choice. A pilot study will be conducted to determine if mixed nuts affect food selection and intake. Questionnaires will also be administered to determine if personality characteristics are also influencing food choice.

Eligibility Criteria:
Inclusion Criteria:

* 21 to 60 Years Old
* 5 year cancer-free

Exclusion Criteria:

* pregnant, lactating, or intending to become pregnant during the study
* known allergy to study foods, including nuts
* use of tobacco products
* history of bariatric surgery or nutrient malabsorption disease or diseases requiring special diet
* Crohn's disease or diverticulitis
* suspected or known strictures, fistulas, or physiological/mechanical GI obstruction
* Type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots
* Self report of alcohol or substance abuse within the past 12 months and/or current acute treatment or participation in a rehabilitation program for those problems (long-term participation in Alcoholics Anonymous is not an exclusion)
Accuracy of Coplanar Template Assistance for Abdominal Tumor Puncture

In recent years, template guidance has been applied and developed in the field of puncture related operations, such as template-assisted radioactive seed implantation. With the guidance of template, needle pathway of seed implantation, biopsy and fiducial marker implantation can be precisely planned actual operation, which is conducive to the accurate proceeding. Templates can be divided into coplanar templates and non-coplanar templates. The digital coplanar template coordinate puncture system has been developed in China and has been applied in clinical practice.

In our previous studies, coplanar template assisted CT-guided radioactive seed implantation has good clinical feasibility for percutaneous biopsy of small pulmonary nodules. However, the accuracy of coplanar template assistance for abdominal tumor puncture are lacking in prospective studies. The study aims to prospectively observe the accuracy and safety of coplanar template assisted CT-guided abdominal tumor puncture during biopsy and fiducial markers implantation.


Eligibility Criteria:
Inclusion Criteria:

1. Ages 18 to 85
2. Single or multiple abdominal tumors or mass (solid, partially solid)
3. Without taking drugs affecting coagulation and/or platelet aggregation are used; If used, the drug has been discontinued for a sufficient period of time (e.g. 1 week)
4. KPS\>60 points, no serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture
5. Planned biopsy and/or fiducial marker implantation with applicable puncture path
6. With informed consent.

Exclusion Criteria:

1. Poor organ function (e.g. lung function FEV1\<40% and/or DLCO\<50%)
2. The lesion close to blood vessels and intestine, or there is portal vein hypertension and superior vena cava compression, etc., which are expected to have high risks of puncture bleeding and intestinal injury
3. Poor compliance, unable to complete coordination
4. Paticipant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.
Efficacy and Safety of Temodal vs Semustine in Subjects With Recurrent Glioblastoma or Anaplastic Astrocytoma (Study P03644)

The primary purpose of the study is to evaluate the efficacy and safety of temozolomide compared to semustine in the treatment of patients with glioblastoma multiforme or anaplastic astrocytoma.


Eligibility Criteria:
Inclusion Criteria:

* Prior histologic confirmation of glioblastoma, anaplastic astrocytoma.
* Evidence of tumor progression or recurrence.
* Age \>=18 years.
* Karnofsky performance status \>=60%.
* Absolute neutrophil count \>=1,500/mm\^3, platelet count \>=100,000/mm\^3, hemoglobin \>=8g/dL.
* Serum BUN and creatinine \<1.5 times upper normal limit of testing laboratory (ULN).
* Total bilirubin and direct bilirubin \<1.5 times ULN.
* SGOT, SGPT \<3 times ULN; alkaline phosphatase \<2 times ULN.
* Life expectancy greater than 3 months.
* Informed consent obtained.
* If palliative radiation is needed, agree to give it prior to initiating chemotherapy with study drug. If palliative radiation is required during treatment with study drug, the patient should be permanently discontinued from further treatment with study drug.
* Women of childbearing potential must use a medically accepted, effective method of contraception.
* Women of childbearing potential must have a negative serum pregnancy test 24 hours prior to administration of study drug.

Exclusion Criteria:

* Chemotherapy (excluding nitrosourea, mitomycin C or vincristine), biologic therapy or immunotherapy within 4 weeks, inclusive, prior to study drug administration.
* Nitrosourea or mitomycin C administration within 6 weeks, inclusive, prior to study drug administration.
* Vincristine within 2 weeks prior to study drug administration.
* Completion of radiation therapy, interstitial brachytherapy or radiosurgery within 4 weeks prior to study drug administration.
* Surgery within 3 weeks, inclusive, prior to study drug administration.
* Acute infection requiring intravenous antibiotics.
* Frequent vomiting or medical condition that could interfere with oral medication intake (eg, partial bowel obstruction).
* Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin.
* Known HIV positive or AIDS-related illness.
* Pregnant or nursing women.
* Men who are not advised to use an effective method of contraception.
Systematic Transthoracic Echocardiographic Screening in Amateur Football Referees

This retrospective study aims to evaluate the prevalence of cardiac abnormalities detected by transthoracic echocardiography (TTE) in amateur football referees as part of a systematic cardiovascular screening program.

cardiovasculaire screening of athletes and sports officials is essential for preventing sudden cardiac death during physical activity. In 2019, the French Football Federation (FFF) introduced mandatory transthoracic echocardiography (TTE) for amateur referees over 18 years old, to improve early detection of cardiovascular abnormalities.

This retrospective observational study investigates the diagnostic value of systematic TTE in detecting structural or functional cardiac anomalies among adult amateur referees affiliated with the Normandy Football League.

The primary objective is to estimate the prevalence of cardiac abnormalities diagnosed by TTE in this population. The secondary objectives include identifying the prevalence of cardiovascular risk factors (CVRFs), and describing the abnormalities found during the medical evaluation

Eligibility Criteria:
Inclusion Criteria:

Male amateur football referees, aged ≥18 Affiliated with the Normandy Football League Completed a baseline TTE No known pre-existing cardiac disease Complete medical records available

Exclusion Criteria:

Referees under 18 or in training status History of cardiovascular disease Incomplete medical file
Buzzy Versus Vapocoolant Spray: Pediatric Needle Pain Relief

A vibrating cold pack placed proximal to the site of venipuncture will decrease the pain of cannulation when compared to vapocoolant spray.

Needle pain is the most common and the most feared source of childhood pain, resulting in needle phobia for 10% of adults. Current pain relief options include numbing creams, vapocoolant spray, or injected lidocaine. 17 million pediatric IV access procedures are done yearly with no pain intervention. An inexpensive, immediately acting form of needle pain control could reduce needle phobia in the long term if demonstrated to be effective for needle pain.

This study will evaluate pain self report and parent report using the Faces Pain Scale revised, and video-coded OSBD-R scores for patients undergoing emergency department venous access or cannulation procedures. Demographic information, pre-procedural anxiety, and success data from the attempts at placement will be included.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring venipuncture in a pediatric emergency department
* Informed consent
* Patient assent

Exclusion criteria:

* Patients with sickle cell or other sensitivity to cold
* Nerve damage in the area
* Abrasion or break in skin where device would be placed
* Critically ill
A Study of Donanemab (LY3002813) in Healthy Chinese Participants

The main purpose of this study is to evaluate the safety and tolerability of donanemab (LY3002813) when administered as single dose in healthy Chinese participants. The study will also assess how fast donanemab gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 85 days.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation
* Participants are native Chinese participants. To qualify as a native Chinese, the participant, the participant's biological parents, and all four of the participant's biological grandparents must be of Chinese origin.
* Have a body mass index (BMI) of 18.0 and 28.0, kilograms per meter squared (kg/m²), inclusive.

Exclusion Criteria:

* Are lactating.
* Are women of childbearing potential.
* Have known allergies to donanemab, related compounds or any components of the formulation or history of significant atopy.
* Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within three months or five half-lives (whichever is longer) prior to dosing.
* Have participated, within the last 30 days, in a clinical study involving an investigational product; at least five half-lives or 30 days (whichever is longer) should have passed.
* Have history of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, stroke or epilepsy.
* Participants who show evidence of positive HIV antibodies, or positive hepatitis C antibody, or positive hepatitis B surface antigen
* Have had leukemia, lymphoma, or any malignancy within the past five years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for three years. Have had breast cancer within the past 10 years.
Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of JP-1366 Oral Administration in Healthy Male Subjects

Clinical trial to investigate the safety, tolerability and pharmacokinetics and pharmacodynamics of JP-1366 oral administration in healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males aged between 19 and 50 at screening
* Weight is between 55 and 90 kg and BMI is between 18.0 and 27.0
* Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc

Exclusion Criteria:

* Subject has clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
* Subject has gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)
* Subject has been Helicobacter pylori positive
* AST (SGOT) and ALT (SGPT) \> 1.5 times to the upper limit of the normal range in screening including additional examinations prior to randomization
* Subject has anatomical disability in insertion and maintenance of pH meter catheter
Evaluation of Functions of Swallowing and Voice in Ankylosing Spondylitis Patients

In this study was to determine whether changes that occurred over time had an impact on the swallowing and voice functions depend of Ankylosing spondylitis patients.

This study was carried out at the University of Health Sciences Okmeydani Training and Research Hospital, Department of Otorhinolaryngology. Study was performed on 30 patients and 30 healthy subjects (Group 2) who were diagnosed with ankylosing spondylitis using modified New York criterion. The patients were asked to fill the EAT-10 and flexible endoscopic swallowing evaluation was performed. Voice recordings were taken from the patients to evaluate the voice disturbance and acoustic evaluation was taken with PRAAT program.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Ankylosing spondylitis
* Person who accept to consent form

Exclusion Criteria:

* Pulmoner diseases
* Laryngeal polip or nodules
* Underwent to larynx or esophageal surgery
* Central nerve system diseases
Enhancing Participation of Chronic Stroke Patients by Constraint Induced Movement Therapy (HOMECIMT)

The aim of this study is to evaluate the efficacy of a modified approach of constraint induced movement therapy ("CIMT at home") for chronic stroke patients, compared to conventional physiotherapy and occupational therapy ("therapy as usual) with regard to the ability to participate in everyday activities.

The study is a parallel cluster randomized controlled trial with therapy practices as clusters. After written consent from the patients, the therapists are randomly assigned to treat either the intervention or the control group. Blinded external assessors evaluate the patients using standardized outcome measures before and after the intervention, and six months later. The two coprimary endpoint assessments of arm and hand function as prerequisites for participation (defined as equal involvement in activities of daily living) are quality of arm and hand use and arm and hand function. Assessments are made four weeks post-treatment and relativized to baseline performance. Changes in primary outcomes are analyzed with mixed models, which consider the hierarchical structure of the data, adjusted to the baseline measurements and sex. The primary analysis compares the two randomized groups, with respect to the adjusted averages for each of the two coprimary endpoints. To keep an overall significance level of 5%, the two endpoints are tested at the significance level of 5% each in hierarchical order.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* Stroke onset \> 6 months prior to study enrollment
* upper extremity hemiparesis with impairment of hand and/or arm
* minimal function of the hand (at least 10º active wrist extension, at least 10º active of thumb abduction/extension, and at least 10º of extension two additional fingers)
* non-professional coach (e.g. family member)
* prescription of physical or occupational therapy

Exclusion Criteria:

* lack of knowledge of German
* serious impairment of verbal communication ability (e.g. severe aphasia)
* inability to consent (e.g. dementia)
* severe neuro-cognitive deficits (MMSE \<23)
* terminal illness, life-threatening co-morbidity
* simultaneous participation in another treatment study targeting stroke recovery
* subjects may not have already received constraint induced movement therapy