cyrilzakka/clinical-trials huggingface dataset:
Sophrology Treatment for Patients With Glial Tumours Requiring Speech Therapy

Patients with brain tumours experience a loss of independence, which may occur suddenly or gradually. Communication with the patient may be rapidly impaired, due to impaired alertness, language and/or neurocognitive disorders.

In addition to these clinical symptoms, there is a high level of anxiety and depression in this population due to the severity of the diagnosis, with a major impact on the patients' quality of life. In this study, we are mainly interested in the proportion of this population with communication disorders where speech therapy is important In order to better take into account anxiety, which is often difficult to verbalise due to communication problems, sophrology can be proposed as an alternative to psychological support, which is often too complicated or inappropriate.

After having noted positive feedback from patients after joint speech therapy and sophrology treatment, we wish to evaluate the interest of coupling sophrology treatment for patients with glial tumours requiring speech therapy.

Our hypothesis is that this association would improve the level of anxiety, the quality of life and have a positive impact on the patient's speech therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven grade III and IV glial tumours requiring speech therapy;
* Patient willing to start outpatient speech therapy;
* Patient aged 18 years and over;
* Informed patient who has signed consent;
* Patient affiliated to a social security scheme.

Exclusion Criteria:

* Patient who has already had an initiation to sophrology in the context of his pathology;
* PS ≥ 4 ;
* Patients suffering from psychiatric disorders; delusional phases, schizophrenia against the practice of sophrology;
* Patient unable to follow the protocol (filling in questionnaires, attendance of sophrology and/or speech therapy sessions) for geographical, social or psychological reasons;
* Patients who do not speak French;
* Persons deprived of their liberty, under court protection, under curators or under the authority of a guardian.
* Women who are pregnant, likely to be pregnant or breastfeeding;
IRIS: Incontinence Research Intervention Study

The IRIS project stands for Incontinence Research Intervention Study. The purpose of this research project is to develop an effective behavioral therapy for urinary incontinence and specifically to test Knack therapy, a self-help treatment. The Knack therapy involves learning the skill of performing a pelvic muscle contraction simultaneously with an event known to trigger leakage, in order to stop that leakage.

This proposal aims to develop and test, in a general population of women with stress urinary incontinence (SUI), a model for predicting who will succeed in overcoming incontinence long-term (1-year) by simply using Knack therapy (thus avoiding invasive and costly surgery and time consuming Kegel's exercises). Specific Aims are to:

* develop a logistic regression model to predict success with the Knack;
* validate the model by determining the proportion of people who succeed according to who is predicted to succeed; and
* develop long-term effectiveness of the Knack (1-year).

The project will be implemented in three phases: model development (n=160 women), model validation (n\~160), and long-term follow-up of women who demonstrate response. This will be evaluated immediately and at 1 month and at 3-months and 1-year.

Eligibility Criteria:
Inclusion Criteria:

* Women who are incontinent
* Women who experience leakage with coughing, sneezing or exercising
* Women who are generally healthy
* Women who are over the age of eighteen
* Women who are not pregnant nor expecting to become pregnant within a year

Exclusion Criteria:

* No urine leakage when coughing, sneezing, or exercising
* Under the age of eighteen
* Pregnant or expecting to become pregnant
* Untreated urinary tract infection
* Pronounced pain or discomfort with pelvic exams
* History of neurologic conditions
Non-invasive Assessment of Synaptic Plasticity

The pathophysiological mechanisms underlying Movement Disorders, including Parkinson's disease, have been related to altered synaptic plasticity affecting several structures of the central nervous system. Although several previous neurophysiologic investigations have shown abnormal long-term potentiation and depression-like plasticity in M1, other regions crucially involved in motor planning and execution, including the spinal cord, have been studied less. Parkinson's disease arises from the progressive loss of dendritic spines followed by atrophy of specific cortical (i.e. M1) and subcortical structures (i.e. putamen). These structural changes are responsible for the main clinical features of PD such as bradykinesia and rigidity. The present research project aims to probe non-invasively the main pathophysiologic mechanisms underlying altered synaptic plasticity in M1 and spinal cord and their relationship in a cohort of patients with movement disorders, including Parkinson's disease. More in detail, the investigators will use specific methodologies able to induce plasticity, including the repetitive transcranial magnetic stimulation (TMS), concerning the M1 and the focal muscle vibration, regarding the spinal cord. The neuromodulation protocol will imply 2 separate sessions, randomly scheduled to take into account the effect of the symptomatic pharmacologic treatment. Furthermore, patients will be randomly assigned to sham or real non-invasive stimulation groups. Before and after the stimulation protocol, the investigators will collect specific clinical as well as neurophysiologic measures (i.e., thresholds) according to standardized procedures. In conclusion, the goal of the study is to investigate the abnormal plasticity in the M1 and spinal cord in patients affected by specific movement disorders, through non-invasive techniques.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of Parkinson's disease

Exclusion Criteria:

* psychiatric disorders, including severe congnitive loss and depression
A Study of an Oral Nutritional Supplement in a Malnourished Population With GI Tolerance Impairment

The purpose is to observe the compliance to a high-calorie, high protein peptide-based nutritional supplement after 3 months in a malnourished population with impaired gastrointestinal tolerance living in nursing homes and as outpatients.


Eligibility Criteria:
Inclusion Criteria:

* Subject is considered malnourished, or is at risk for malnutrition based on MUST score ≥2.
* Subject is ≥18 years old.
* Subject has a condition that would benefit from a high calorie, higher protein ONS for GI tolerance impairment (e.g., diarrhea, nausea, vomiting, satiety or bloating).
* Subject conforms to the requirements set forth on the study product label.
* Subject is under the care of a health care professional for malnutrition and has recently (within the last 7 days prior to participating in this study) been prescribed 2 servings/day of the study ONS. Subject must have been naïve to ONS for GI tolerance impairment prior to being prescribed the study ONS.

Exclusion Criteria:

* The study physician determines the subject is not fit to participate
* Subject cannot provide informed consent to participate in the study.
* Subject cannot safely consume the oral nutritional supplement.
* Renal or liver failure (GFR\< 60 ml/min or AST/ALTx3 normal) upper limit.
* Type 1 or type 2 diabetes.
Weight Loss in Patients With COVID-19 and Influenza in Comorbidity With NCDs: a Pilot Prospective Clinical Trial

The goal of this study was to evaluate the effects of the fast weight loss on clinic and laboratory inflammation profile, metabolic profile, reactive oxygen species (ROS) and body composition in patients with COVID and Influenza in comorbidity with NCDs.

Primary endpoints: Clinic/infectious/inflammation tests for COVID and Influenza; weight loss during 14 days. Secondary endpoints: fasting blood glucose, HbA1c, blood insulin; systolic/diastolic BP; blood lipids; ALT, AST, chest CT-scan.

Study Design. A 6-week, open, pilot prospective clinical trial with the intention-to-treat principle.

Participants: The study enrolled 72 adult people (38 women) aged from 25 to 80 years with moderate-to-severe cases COVID and Influenza in comorbidity with NCDs as T2D, hypertension, and NASH. All patients with the ARDs had in comorbidity with one or more NCDs. All patients refused for pharmacology therapy due to: either previous unsuccessful drug results; or an antimicrobial resistance profile; or drug allergy; or reluctance to take medication; or iatrogenic fear (iatrophobia); or a rich failed experience in drug treatment; and NASH.

All the patients were admitted into the out-patient department in 3-5 days after illness onset. The study was carried out in the Republic of Kazakhstan from November, 2020, through July, 2022 at University Medical Center (Astana) and ANADETO medical center.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent form;
* patients with fever
* patients refused for pharmacology therapy
* weight loss treatment for 12-14 days and +4 weeks follow-up (total 6 weeks)

Exclusion Criteria:

* patients with acute respiratory failure and assisted ventilation requirement
* respiratory rate ≥ 30 times per minute
* oxygen saturation ≤ 93% by finger oximetry at resting status
Effect of SVV-guided Fluid Therapy on Outcomes After Major Abdominal Surgery

The investigators conduct this randomized assessor-blinded controlled trial to evaluate the effect of SVV-guided fluid therapy on postoperative morbidity and mortality in comparison with conventional fluid therapy after major abdominal surgery. Half of participants will receive GDFT perioperatively, and the others will receive conventional fluid therapy

Perioperative fluid management has been recognized as an important factor with an impact on postoperative recovery following major abdominal surgery. However, the optimal fluid management is difficult to achieve using standard parameters (e.g., heart rate \[HR\], blood pressure \[BP\], central venous pressure\[CVP\], or urine output) that poorly estimate preload and preload responsiveness. Goal-directed fluid therapy (GDFT) was proposed by introducing different hemodynamic variables into a dynamic perspective of individual fluid loading with or without vasoactive substances to reach predefined goal of optimal preload and/or oxygen delivery.There have been increasing numbers of studies evaluating the effect of perioperative GDFT on postoperative recovery following major abdominal surgery. However, the evidence for the beneficial effect of GDFT on postoperative recovery remains inconsistent.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (aged 18 to 80 years)
2. ASA I\~III
3. BMI:18\~30kg／m2
4. Procedures were considered major if listed for resection of gastrointestinal, gynecologic, and urologic cancer with tumor debulking, staging or reconstruction with a risk for significant surgical blood loss

Exclusion Criteria:

1. Patients under 18 years,
2. pregnant or lactating woman
3. patients with esophageal or gastric surgical history
4. co-existing congestive heart failure; chronic lung disease; or renal or hepatic dysfunction (creatinine \>50 % or liver enzymes \>50 % of normal values), and arrhythmias-operative down staging using chemotherapy and/or radiation therapy
5. patients undergoing emergency surgery
6. patients with co-existing congestive heart failure; chronic lung disease; or renal or hepatic dysfunction (creatinine \>50 % or liver enzymes \>50 % of normal values), and arrhythmias
Comparative Effects of Dry Needling and Ischemic Compression Technique on Scalene Myofascial Pain Syndrome

Myofascial Pain Syndrome (MPS) is a medical term used to describe chronic regional pain syndrome that presents with hyperirritable spots called trigger points (TPs) and/or tender spots (TSs) that arise from taut bands (TB) in the skeletal muscle. Scalene myofascial pain syndrome is a regional pain syndrome wherein pain originates over the neck area and radiates down to the arm. Functionally, MPS causes the muscle to become weak and stiff, leading to reductions in range of movement. Thus, MPS is known as a major cause of morbidity, with a significant impact on daily activity, function and quality of life. The aim of this study is to compare the effects of dry needling versus ischemic compression technique on trigger points of scalene in neck pain, related disability and neck active range of motion among patients with scalene myofascial pain syndrome.

A Randomized clinical trial will be conducted at DHQ Gujranwala and Sikandar medical complex Gujranwala through convenience sampling technique on 24 patients. Patients with scalene myofascial pain syndrome between age from 18 years to 45 with positive Scalene Cramp Test will be included in study. Patients will be accessed for neck pain, disability and active range of motion. They will be allocated through simple random sampling through sealed opaque envelopes into group A and group B. Patients in dry needling (DN) group will receive a single session of DN with sterile needles insert on trigger points in scalene muscles as first twitch response will obtained needles will be manipulated in and out of the muscles to get 2 or 3 more local responses. Patients in Group B will receive a single session of ischemic compression technique for this ischemic compression technique sustained pressure on the trigger points will be maintained for 30 seconds. Control treatment will be same for both groups. Pre and post treatment values will be identified after one month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with scalene myofascial pain syndrome
* Age from 18 years to 45
* Patients with positive Scalene Cramp Test

Exclusion Criteria:

* Whiplash injury
* Thoracic dysfunction any cervical radiculopathy
* Age below 18 and more than 45 years
* Any psychiatry disorder or
* Any contraindication to Dry Needling
Evaluating the Dietary Supplement Anatabloc in Thyroid Health-ASAP (Antabloc Supplementation Autoimmune Prevention)

This is a study to evaluate the safety, tolerability, and potential effects of Anatabloc dietary supplementation on antithyroid autoantibodies, thyroid structure, and thyroid function in subjects with autoimmune thyroiditis.

This is a 5-visit, 12-week, double-blind, randomized, placebo-controlled, parallel-group study.

Eligibility Criteria:
Inclusion Criteria:

* adults 18-70 years of age
* having positive antibodies against thyroid peroxidase
* having sonographic evidence consistent with a diagnosis of Hashimoto's thyroiditis

Exclusion Criteria:

* having evidence of end-stage thyroiditis
* being a current smoker or smokeless tobacco user
* be taking systemic glucocorticoids, interferon-alpha, anti-CD20 antibody, or anti-CTLA-4 antibody
* be taking any medication for treatment of autoimmune thyroiditis other than L-thyroxine or equivalent
Sarcopenia and Outcomes of Neuroplasty in Lumbar Spinal Stenosis

The aim of the present study is to find out the influence of sarcopenia on outcomes of neuroplasty in patients with lumbar spinal stenosis.

Frailty is an aging-related syndrome of physiological decline and correlated with sarcopenia. Furthermore, lumbar spinal stenosis is a common disease in the old population and a neuroplasty is widely used to treat these patients. We postulate that the sarcopenia may be associated with the outcome of neuroplasty in patients with lumbar spinal stenosis, and there is no study about this topic as far as we know.

To evaluate this association, we will use the criteria for sarcopenia which is made by Asian Working Group for Sarcopenia in 2019 in this study. We will compare the outcome of neuroplasty in patients with sarcopenia and without sarcopenia using several tools such as numeric rating scale (NRS), Oswestry Disability Index (ODI), and global perceived effect (GPE) score up to 6 months after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Presence of lumbar spinal stenosis on MRI
* 65 ≤ age \<79
* Neurogenic claudication due to spinal stenosis
* Chronic pain above than 3 months despite conservative therapies
* Scheduled for neuroplasty with Racz catheter

Exclusion Criteria:

* Allergy to local anesthetics, contrast dye, or steroid
* Use of anticoagulants or antiplatelet medication
* Coagulopathy or Infection at the insertion site
* Neurological or psychiatric disorders
* Hemodynamic instability due to other underlying disorders
* Prior spine instrumentation
* Vascular claudication
* Refusal to participate in the study
Influence of Regular Physical Activity on Sleep in Patients With COPD and Idiopathic Lung Fibrosis

The study looked at whether regular physical activity can influence sleep duration, sleep quality and/or anxiety in patients with chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF).

The link between exercise and sleep has already been observed in the literature, but the impact of exercise on sleep is poorly understood. The question is how important is the influence of regular physical activity on sleep, anxiety and depression in patients with COPD or IPF.

Patients will be selected in two ways:

1. Intervention group: patients with COPD or idiopathic fibrosis following rehabilitation program in our center, who meet the inclusion criteria will be invited to participate in the survey and answer the questionnaires during the first week and again eight weeks after the start of the rehabilitation program.
2. Control group: patients with COPD or idiopathic fibrosis who do not perform any regular physical activity will be invited to participate in the survey and answer the questionnaires.

The questionnaires are validated and the time allowed for completion is 45 minutes. The questionnaires will assess sleep quality, anxiety and symptoms of depression.

Eligibility Criteria:
Inclusion Criteria:

* Patients with COPD.
* Patients with Idiopathic Pulmonary Fibrosis.
* Patients who can read and write in French.
* Patients who agree to participate in research and sign the informed consent form.
* Patients who participated of our rehabilitation program or Patients who do not do any regular exercise activity.

Exclusion Criteria:

* Regular use of Continuous Positive Airway Pressure devices (CPAP)
Evaluation of the NOVATECH ® LUCIOLA TM EB Fiducial Marker During Radiotherapy Sessions in Lung Cancer Patients

Following CE certification, this Post Market Clinical Follow-up investigates the performance and safety of using the new fiducial marker, NOVATECH® LUCIOLA™ EB, in the lung airways to monitor in real-time tumor location during radiotherapy.

At the time of insertion near the tumor, the Luciola's 3 fiducial marker arms are deployed simultaneously. Optimal detection of the fiducial marker is considered during the radiotherapy treatment.

NOVATECH® LUCIOLA™ EB fiducial marker will be implanted near the lung tumor by bronchial endoscopy by a pulmonologist. Following a dosimetry visit, participants will be proposed a maximum of 5 radiation therapy sessions. A follow-up visit at 3 months will take place after the last radiotherapy session. The participation period for each participant will be between 4.5 and 6 months. This study will evaluate the Luciola implant's performance and safety (visibility, migration, complications, tumoral response).

Eligibility Criteria:
Inclusion Criteria:

* Participants ≥ 18 years of age
* Participants with primary, secondary or metastatic lung cancer with an indication for radiotherapy and placement of a fiducial marker
* Participants who will be able to tolerate the flexible bronchoscopic implantation procedure and radiotherapy treatment.
* Participants who give their written informed consent

Exclusion Criteria:

* Participants with uncontrolled infection / participants with active infections.
* Participants with a bronchoscopy contra-indication
* Pregnant or breast-feeding women
* Participants with known allergy to one of the components (tantalum and nickel titanium alloy for the marker and polymer materials which are contained in the delivery device)
Active Surveillance vs in Office Fulguration for Low Grade Bladder Cancer Tumors

Biological behabiour of low grade bladder cancer tumors is well known. They have a very high rate of recurrences during their follow up but very low (less than 1%) risk of progression.

Until now, the gold standard of any bladder recurrence for this patients is performing an immediate transurethral ressection of the tumor.

This surgery has risk of complications and, due to the low risk of these subgroup of tumors, sometimes it becomes an overtreatment for the patients.

This is the reason why new conservative or less invasive surgeries are proposed to follow up and treat these patients.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent Ta-T1a (above muscularis mucosa) LOW GRADE bladder tumor
* Accept cystoscopy surveillance
* Main lession less than 10mm
* Less than 7 lesions
* Negative or low grade cytology
* No solid aspect

Exclusion Criteria:

* previous High grade bladder cancer tumors
* previous Cis
* previous Upper Urinary Tract tumor
* previous pelvic radiotherapy
* hematuria
* meatal localisation
Evaluation of the Spark of Duval Intervention

The S.P.A.R.K (Speaking to the Potential, Ability, and Resilience inside Kids) Teen Pregnancy Prevention and Mentoring program is being administered to youth (ages 11-17) living in out-of-home foster care in Duval County, Florida. Children's Home Society of Florida in Jacksonville received grant funding for the implementation and evaluation of the S.P.A.R.K program. The University of South Florida is examining the effects of intervention on reducing youth involvement in risky sexual behavior and incidents of teen pregnancy.

The evaluation is conducting an individual randomized controlled trial to test the S.P.A.R.K. (Speaking to the Potential, Ability, and Resilience inside Kids) Teen Pregnancy Prevention and Mentoring intervention with youth assigned to either the intervention or control group. As youth are referred to the study, grantee staff confirm their eligibility and then work with the youth's child welfare case manager to obtain youth assent and parental consent. Once approximately 40 to 60 youth are recruited, grantee staff selects a day for baseline survey administration. Survey administration and group assignment take place at the grantee agency and incentives to complete the survey are provided including a gift card and snacks. All eligible youth with a signed assent and informed consent forms are invited to attend the baseline survey administration and group assignment. The evaluation team generates random numbers using computer software, and the grantee staff uses these numbers to indicate youth assignment to the intervention or control group, after youth have completed the baseline survey.

Eligibility Criteria:
Inclusion Criteria:

* Youth aged 11-17, living in out-of-home foster care in Duval County, FL (Florida) are eligible for participation. Only youth who have provided assent and have received parental/guardian informed consent are included in the study.

Exclusion Criteria:

* Youth who are teen parents, expectant parents, or currently living in residential facilities are excluded from the study.