cyrilzakka/clinical-trials huggingface dataset:
Effect of Lower Limb Constraint Induced Movement Therapy Using a Torque-Assisted Exoskeletal Wearable Device

The aim of this study was to investigate the effects of lower limb constraint induced motor therapy using the robotic rehabilitation device on ambulatory function in chronic stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 19 years or older
* Patients with hemiparesis due to ischemic or hemorrhagic stroke
* Patients in the late subacute or chronic phase, at least 3 months after the onset of stroke
* Individuals who can independently walk with a Functional Ambulatory Category score of 3 or higher
* Patients who are able to use Torque-Assisted Exoskeletal Wearable Device Height: 140 cm to 190 cm Weight: 80 kg or less Shoe size: 230 mm to 290 mm
* Patients who were independent walkers and had no difficulties performing activities of daily living (mRS ≤ 1)

Exclusion Criteria:

* Patients with severe cognitive impairment (MMSE \<10) or significant communication difficulties such as speech disorders
* Patients with spasticity in one-sided lower limbs, rated 2 or higher on the Modified Ashworth Scale (MAS)
* Patients with severe musculoskeletal disorders of the lower limbs
* Patients with contractures that limit the range of motion in the lower limbs
* Patients with an apparent leg length discrepancy of 2 cm or more
* Patients with fractures, open trauma, or non-healing ulcers in the lower limbs
* Patients with serious internal diseases such as cardiovascular disease or pulmonary disease that make it difficult to use Exoskeletal Wearable Device for walking therapy
* Patients with a history of osteoporotic fractures
* Patients with other neurological disorders affecting walking (e.g., Parkinson's disease, multiple sclerosis, etc.)
* Any other cases where the investigator determines that participation in this study is inappropriate
High Resolution Imaging for Analysis of MVNT

MVNT (multinodular and vacuolating neuronal tumor of the cerebrum) is a benign, recently discovered, neuronal lesion, the incidence of which is unknown.

It seems to predominate in the temporal lobes and presents a characteristic MRI appearance: multiple subcortical nodules, developed at the white substance / gray substance junction, of variable size, well limited, in iso-hyposignal T1, hypersignal T2 and hypersignal FLAIR.

The articles describing this entity report the lack of scalability in MRI during patient monitoring, going in the direction of the benignity of the lesion.

The diagnosis sometimes remains uncertain with current MRI sequences, and the patient risks undergoing invasive surgery to remove a lesion that is actually benign. Hence the importance of developing the most precise diagnostic criteria possible. The contribution of advanced MRI techniques, such as ultra-high resolution sequences in the characterization of these lesions, has not yet been studied.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Prospective inclusion of all patients with suspected MVNT on a first exploratory MRI: at least the 2 major criteria associated with at least 1 minor criterion will be required to fit into the definition of suspected MVNT:

  * Major criteria :

    * Multinomodular clustered appearance
    * Franc hypersignal FLAIR/T2
  * Minor criteria :

    * No mass effect
    * Hyposignal T1
* Having received informed information about the study and having given express consent to participate in the study

Exclusion Criteria:

* Contraindication to MRI
* Patient benefiting from a legal protection measure
* Pregnant or breastfeeding woman

Secondary exclusion criteria:

- No characterization MRI done
Major Activation Of NCC in Graft Urinary Exosomes

Hypertension is common disorder after renal transplantation and is associated with mortality. Calcineurin Inhibitor (CNI), by activating NCC cotransporter, may be a major determinant of hypertension, included in a "Gordon like" syndrome. However, prevalence of NCC activation by CNI is unknown. Our objective is to determine the prevalence of NCC activation three months after transplantation in patient treated by CNI.

Hypertension is common disorder after renal transplantation and is associated with mortality. Calcineurin Inhibitor (CNI), by activating NCC cotransporter, may be a major determinant of hypertension, included in a "Gordon like" syndrome. Gordon syndrome is a rare genetic disorder where NCC cotransporter is overactivated and cause hypertension, metabolic acidosis and tendency to hyperkaliemia. Few studies evaluated NCC expression by exosomes techniques in human kidney transplant, and mostly compared NCC expression in specific subpopulation (for example with or without hypertension). Thus, prevalence of NCC activation by CNI is unknown. To determine it, we will include prospective patients in Bordeaux and la Réunion who undergo urine and blood tests three months after transplantation, and a control group with no transplantation and no use of CNI. First, we will compare kidney recipients and control and use immunoblot to quantify NCC expression in urinary exosomes to identify the population of transplanted with a high activation. Then, we will analyze the relationship between NCC activation and clinicobiological features of Gordon's syndrome.

Eligibility Criteria:
For kidney transplant group :

* inclusion criteria:

  * Age≥18years
  * Recipients three months after kidney transplantation using calcineurin inhibitors
  * Glomerular Filtration Rate\>15ml.mn.m2 CKD-EPI
  * Renal ultrasound underwent before inclusion
  * No opposition at participating at the research
* exclusion criteria:

  * Use of diuretic thiazides or aldosterone receptor antagonists in the month preceding inclusion
  * Graft artery stenosis with indication of interventional radiology or surgery

For control group :

* Inclusion criteria

  * No previous transplantation
  * Age≥18years
  * No hypertension
  * No metabolic disorders (dysnatremia, dyskaliemia, acidosis or alkalosis)
  * No opposition at participating at the research
* Exclusion criteria:

  * Use of diuretic thiazides or aldosterone receptor antagonists in the month preceding inclusion
Interest of Hydrophysiotherapy Care in Parkinson Disease's Motor and Non-motor Symptoms

Parkinson Disease (PD) is a neurodegenerative disorder who begin around 55 years old, characterized by brain's backmatter's dopamine neuron destruction, involved in motor control. Diagnosis is made with presence of 3 of 4 disease's cardinal sign: bradykinesia, rigidity, resting tremor, walking troubles. Treatments enhance patient's quality of life, but do not allow to stop disease's evolution, who is specific depending on a lot of factors. For some years, PD's non motor symptoms (NMS) - in particular pain, anxiety, depression, sleep disorders - have been highlighted and turn out to impair sometimes quality of life even though motor symptoms are controlled. This project's main aim is to evaluate if aquatic environment's care lead to an advantage on PD's NMS, symptoms currently underestimated, insufficiently in care and having a harmful influence on quality of life. Collaboration of the University Hospital (Neurology Dpt), the Physical Medicine and Rehabilitation Regional Institute, Grand Nancy Thermal, and France Parkinson Association, will allow in this way to offer on PD's NMS, postural control impairments, and walking troubles an alternative or further non-pharmacological therapy.


Eligibility Criteria:
Inclusion Criteria, patient:

* having get a complete information on study's organization and having given written informed consent,
* affiliated to a social security system,
* suffering from Parkinson's disease (stage 2 or 3 of Hoehn and Yahr),
* with motor fluctuation lower than 25% of awaked time,
* with dyskinesia lower than 25% of awaked time (according to MDS-UPDRS scale),
* with stable pharmacological treatment during the 30 days before study,
* already benefiting of a physiotherapy.

Exclusion Criteria, patients:

* receiving treatment by apomorphine or Duodopa pump,
* benefiting of brain stimulation,
* taking occasionally benzodiazepine,
* with dementia (MDS-UPDRS 1.1 score \> 3),
* having had a sprain on a lower limb joint 3 months or less before the beginning of study,
* having head trauma consequences,
* having vertebrae pain,
* with freezing,
* having skin trouble leading to a contraindication of aquatic activities,
* concerned by L. 1121-5, L. 1121-7 and L 1121-8 articles of French public health code.
Study With Various Immunotherapy Treatments in Participants With Lung Cancer

The purpose of this study is to assess the objective response rate (ORR) of immunotherapy-based combination therapy and to assess the safety and tolerability of immunotherapy-based combination therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented Stage IV metastatic, NSCLC
* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1
* At least one measurable target lesion per RECIST v1.1.
* Adequate organ function
* Participants must be willing to provide adequate tumor tissue

Exclusion Criteria:

* Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of Investigational Product(s) (IPs) hazardous
* Use of any live vaccines against infectious diseases within 28 days of first dose of IP(s).
* Use of supra-physiologic doses of corticosteroids (\> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications ≤ 14 days before the initiation of study treatment (absorbable topical corticosteroids are not excluded).
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study of ZG005 in Patients With Advanced Solid Tumors

This is a multi-center, open-label, Phase 1/2 study of ZG005 for the treatment of subjects with advanced solid tumors, and consists of three stages: dose escalation and confirmation of MTD/recommended dose.


Eligibility Criteria:
Inclusion Criteria:

* Fully understand the study and voluntarily sign the informed consent form.
* Male or female 18-70 years of age;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;
* Life expectancy ≥ 3 months;
* Histologically or cytologically confirmed diagnosis of advanced solid tumors.

Exclusion Criteria:

* Medical history, computed tomography (CT) or magnetic resonance imaging (MRI) results indicate that existence of the central nervous system(CNS) metastases;
* Any other malignancy within 5 years.
Feasibility of Telephone Follow-up Visits in Primary Care

Doctors frequently speak with their patients over the telephone. Having a visit with a doctor over the telephone rather than face-to-face can be convenient for patients and allow them to save time and money on transportation and missed time from work. However, some patients may prefer seeing the doctor in person. In this study, we will study two groups of patients - some who have their visits with their doctor over the telephone and some who have them face-to-face. Using surveys and interviews, we will study if the groups differ in their satisfaction with their visit with their doctor after participating in the study for 6 months. We will also look at doctor satisfaction with telephone visits, use of clinic resources and if patients received recommended care such as laboratory tests and vaccines during the study period.

This two arm randomized controlled trial will evaluate the effect of telephone follow-up versus standard in-person follow-up (usual care) on patient satisfaction among a sample of 360 primary care patients followed at the Gouverneur Ambulatory Care Practice. All primary care patients will be considered eligible at the outset. Providers will determine patient's study eligibility at the baseline visit based on the ability to safely follow-up the patient's health issue over the telephone in subsequent visits. Eligible patients that are randomized to the telephone follow-up arm will have their next medical visit with their primary care provider via a telephone call. Eligible patients that are randomized to the usual care arm will have a standard in-person clinic visit with their primary care provider. In both study arms, the timing and frequency of follow-up appointments will be determined by the patient's primary care provider. Regardless of group assignment, outcomes will be assessed at the baseline and 6-month study visit.

Eligibility Criteria:
Inclusion Criteria:

* Have a follow-up issue that can be addressed over the phone (as determined by their provider);
* 18 years of age or older;
* Have a working telephone number; and
* Are English, Spanish, Cantonese or Mandarin-speaking.

Exclusion Criteria:

* Patient refusal or are unable to provide informed consent;
* Currently participate in another clinical trial;
* Have significant psychiatric comorbidity or cognitive impairment that would compromise their ability to participate (as determined by their provider); or
* Plan to discontinue care at the Gouverneur Ambulatory Care Practice within the next 6 months
Comparative Effects Of Dynamic And Static Stretching In Postmenopausal Females With Knee Osteoarthritis

As the aging population continues to grow, there is a pressing need to explore effective interventions to alleviate the symptoms of osteoarthritis, particularly in postmenopausal women who may experience unique challenges. Osteoarthritis (OA) is progressive joint disease characterized by joint inflammation and a reparative bone response and is one of the top five most disabling conditions that affects more than one-third of persons \>65 years of age, commonly affecting hands, feet, spine, hips, and knees. Among the various therapeutic modalities, stretching exercises, both dynamic and static, have gained attention for their potential to enhance joint flexibility, reduce pain, and improve functional outcomes.

The study will be a randomized clinical trial and will be conducted in Jinnah Hospital, Mafaza-Tul-Hayat Hospital Lahore and Mayo Hospital Lahore. This study will be completed in time duration of 7 months after the approval of synopsis. Non-probability convenience sampling technique will be used and 58 participants will be recruited in study after randomization. The subjects will be divided into two groups. Group A will receive dynamic stretching of hamstrings and quadriceps with static stretching and Group B will receive dynamic stretching without static stretching after warm up as baseline treatment. The tools that will be used are Osteoarthritis outcome scale Goniometer Lower extremity function scale, Strength, MMT, NPRS, after data collection data will be analyzed by using SPSS version 21

Eligibility Criteria:
Inclusion Criteria:

* Age 50 to 65
* Diagnosed patients of OA with grade 3
* Multiparous (5 children)
* Fertile females
* Pain greater than 6 on NPRS

Exclusion Criteria:

* BMI \> 30
* Early menarche ≤10 or 11 years.
* Cancer i.e breast cancer ,Ovrian cancer
* Any bone deformity before menopause i.e limb length discrepancy, angulation
Brain-heart Interactions in Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X:

The Tako-Tsubo Cardiomyopathy (TTC) and the Cardiac Syndrome X (CSX) are respectively acute and chronic heart diseases, which mimic myocardial infarction and stable angina pectoris without alterations of large coronary vessels. The causes and the most appropriate and best treatment for these diseases have not been yet clarified, but there are indications, that mental and psychosocial aspects may also contribute to these two diseases. So far, there is no study, which has comprehensively evaluated the interactions between mind and heart in these two conditions.

The purpose of this study is to search for possible differences in mental activity, response to stressful events and function of specific areas of the brain deeply involved in relation between mind and heart.

45 subjects will be recruited and divided equally into: patients with CSX, patients with TTC (at least 6 months ago) and patients with previous acute myocardial infarction (at least 6 months ago). All participants will undergo a clinical interview and several questionnaires that assess various mental functions, the stress response and the quality of life. In addition, in a separate visit the participants will undergo a Magnetic Resonance Imaging without contrast medium that helps to assess function of specific areas of the brain.


Eligibility Criteria:
Inclusion Criteria:

* Group A. 15 patients with Cardiac X Syndrome (CSX), according to the diagnostic criteria previously proposed by Lanza et al.
* Group B. 15 patients with Tako-Tsubo Cardiomyopathy (TTC), according to Mayo diagnostic criteria at least 6 months after being hospitalized or diagnosed with TTC.
* Group C (control group). 15 prospectively enrolled patients with previous Type 1, 4a, 4b myocardial infarction (ST-segment elevation acute myocardial infarction \[STEMI\] and Non ST-segment elevation acute myocardial infarction \[NSTEMI\] acute coronary syndrome \[ACS\] with significant ≥70% coronary stenosis) at least six months after the event.

Acute myocardial infarction will be defined according to the third universal definition of myocardial infarction.

Exclusion Criteria:

* Refused consent
* Unable to participate or provide written informed consent
* Short-term survival (\<1 year)
* Acute or decompensated medical conditions
* Acute neurological or psychiatric diseases
* Absence of sinus rhythm or frequent ectopic beats
* History of severe lung, liver, kidney or autoimmune diseases
* Any contraindication to MRI
Telespirometry in Amyotrophic Lateral Sclerosis (ALS)

The investigators seek to validate Slow Vital Capacity (SVC) measurement in seated and supine positions using conventional and portable spirometry.

SVC is obtained with in-clinic conventional spirometry, in-clinic portable spirometry, and in-home portable spirometry with respiratory therapist-supervised remote pulmonary function testing every two weeks in a six month prospective study of participants with a diagnosis of Amyotrophic Lateral Sclerosis. SVC decline over time, seated and supine, will be tracked with assessments for treatment changes.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of ALS as Clinically Possible, Clinically Probable, Laboratory-supported Probable and Clinically Definite ALS
2. 18 years old to 100 years old, English-speaking ALS subjects, male and female

Exclusion Criteria:

1. Use of non-invasive ventilation more than 16 hours daily
2. Non-English Speaker
3. Psychosis or severe mental illness
4. Use of high-dose sedating psychotropic medications determined to potentially interfere with task performance
5. Infection Control issues and specific Pulmonary, Cardiac, Vascular contraindications as listed in the Standardization of Spirometry 2019 Update (Graham 2019)
The Effects of Autologous Fat Transfer on Preventing Expanded Skin From Expansion Failure

The purpose of this study is to evaluate whether autologous fat grafting is safe and/or effective to prevent expanded skin from expansion failure.

The repair of skin defects is a common problem for reconstructive surgeons.Soft tissue expansion is a widely used technique for the repair of skin defects. Early expansion-related complications such as skin thinning, telangiectasia, and striae may result in expansion failure and ultimately jeopardize final outcome. In the past years, discontinuation of the expansion procedure was the only therapeutic option, when early alarm signs such as semitransparent appearance and telangiectasia of the expanded skin were encountered. We aimed to overcome these complications by therapeutic fat grafting to prevent skin necrosis and enable continuation of the expansion procedure.

Patients undergoing soft tissue expansion treatment for resurfacing skin lesions including scars and nevi that required therapeutic intervention due to early complication signs were included in this study. Patients were randomly divided into treatment group using autologous fat grafting and control group with discontinued expansion and expectant management. The treatment group received autologous fat transfer to the expanded skin.

Eligibility Criteria:
Inclusion Criteria:

* Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back;
* Implanted silicone expander of 50 to 800 ml in size;
* History of deterioration in the expanded skin texture that did not improve after the inflation procedure was suspended for more than 2 weeks;
* Persistent high level of expander internal pressure;
* Need for further skin expansion;

Exclusion Criteria:

* Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; or history of delayed healing, radiational therapy;
* Rupture of expanded skin, expander exposure;
* Significant renal, cardiovascular, hepatic and psychiatric diseases;
* Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV);
* BMI less than 17 or insufficient subcutaneous fat;
* History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis;
* History of allogenic bone marrow transplantation;
* Pregnant or lactating woman;
* Long history of smoking;
* Evidence of malignant diseases or unwillingness to participate
Therapy-Associated Saliva and Taste Change Evaluation (TASTE) in Head & Neck Cancer Patients Undergoing Radiotherapy

One of the main side effects of radiation therapy to the head and neck region is altered taste sensation. This causes significant morbidity and has profound effects on the quality of life (QoL) of patients. While radiation-associated toxicities like xerostomia and dysphagia are part of large investigations, data on taste impairment is sparse.

The TASTE study sets out to further our understanding of this common side effect with the goal to prevent radiation-associated taste impairment in future patients.

In this prospective, observational multicenter study 150 head and neck cancer patients undergoing radiation therapy will be recruited. Participants will undergo repetitive (semi-) objective and subjective assessment of their taste, smell and salivary function at specific time points before, during and after radiotherapy. Primary endpoint will be patient-reported taste impairment 12 months post radiation therapy using a standardized quality of life questionnaire (MDASI-HN). Secondary endpoints will include taste impairment measured using taste strips at 12 months and 2 years post radiation therapy. Differences between subgroups (radiation side, chemotherapy, etc.) and changes over time will be assessed while adjusting for confounding factors (e.g. age, sex, smoking history). Based on the aquired data, a normal tissue complication probability model for late radiation-associated taste impairment will be develeoped.


Eligibility Criteria:
Inclusion Criteria:

* Head and neck cancer patients
* Referred for radiation therapy with curative intent, both definitive and post-operative
* Age ≥18
* Karnofsky performance index of at least 50%
* Anticipated mean radiation dose to the taste bud bearing tongue mucosa or at least one of the major salivary glands (parotid, submandibular, and/or sublingual gland) of at the minimum 5 Gy

Exclusion Criteria:

* Pregnancy
* Pre-existing subjective complete loss of taste before start of radiation therapy
* Planning CT and radiation therapy with oral stent or spacer
* Partial or total glossectomy which impairs taste assessments of at least one side of the tongue or impairs contouring of the taste bud bearing tongue mucosa on the planning CT
* Inability to follow instructions related to study procedures or inability to fill in the questionnaires
* Inability to provide informed consent