cyrilzakka/clinical-trials huggingface dataset:
Biomarkers for Fatigue in Patients with Myasthenia Gravis

Rationale: Myasthenia Gravis (MG) is a chronic autoimmune disease affecting the neuromuscular junction. Although a hallmark of MG is muscle fatigability due to dysfunction of the neuromuscular junction (peripheral fatigue), a large number of MG patients also report symptoms of central or cognitive fatigue. Central fatigue is defined as an experienced lack of energy, physically and/or mentally. In October 2019 we performed a cross-sectional survey study (P15.287) among 420 Dutch MG patients showing a clinically relevant central fatigue rate of 62% on the Checklist Individual Strength-Fatigue subscale (CIS-f). In this prior study, we identified a number of factors associated with fatigue, but these factors cannot fully explain the observed high prevalence of fatigue in MG and very little is known on its biological substrates and pathophysiology.

Objectives: The main objective is to investigate if there are biomarkers for fatigue in MG. The secondary objective is to investigate the muscle origin of these biomarkers.

Study design: This study will be an exploratory study, subdivided in part I and part II (optional).

Study population: Patients with Myasthenia Gravis recruited after previous participation in the cross-sectional fatigue survey study (P15.287).

Intervention:

Phase I:

Visit 1, time: 0

* blood withdrawal
* muscle biopsy (not mandatory for participation)
* QMG
* questionnaires on medication, disease severity, fatigue, depressive symptoms and physical condition

Phase II (optional):

Visit 2, time: 6-12 months after visit 1, after analysis of phase I results.

* blood withdrawal (similar analysis as phase I)
* QMG
* questionnaires on medication, disease severity, fatigue, depressive symptoms and physical condition


Eligibility Criteria:
Inclusion Criteria:

* Male of female patients aged ≥ 18 years
* Subjects must understand the requirements of the study and provide written informed consent.
* Diagnosis of MG:

  * Clinical signs or symptoms characteristic for MG and
  * A positive serologic test for AChR antibodies

Exclusion Criteria:

A medical history of other active auto-immune disorders for which the patient currently receives a medical treatment, such as thyroid disease or rheumatoid arthritis.

* A medical history of neoplasms within the last year.
* Substance abuse.

Exclusion criteria for muscle biopsy

* The use of anticoagulants therapy.
* Allergy for lidocaine
Assessment of Patient Experience During Treatment for Cancer

Assessing the mindset of cancer patients will help us better understand which patients are having difficulty dealing with the diagnosis and treatment that may not otherwise be fully appreciated by their physicians. By identifying such patients, we may then be able to design and implement strategies that can help improve their coping skills both during the treatment as well as after the completion of treatment. In addition to addressing physical concerns and symptoms, this approach will help address the overall emotional impact of a cancer diagnosis as more patients are living as cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically diagnosed carcinoma patients at Stanford cancer center who signed the informed consent form.

Exclusion Criteria:

* Patients with a prognosis of \< 6 months life expectancy
Experimental Study to Evaluate the Impact of 18 Fluoro-PSMA (18F-PSMA) PET / CT in the Management of Patients with Prostate Cancer.

Single-center, prospective, open-label, not randomized, diagnostic phase II trial in the management of patients with prostate cancer.

Single-center, prospective, open-label, not randomized, diagnostic phase II trial in the management of patients with prostate cancer. The aim of this study is to evaluate the additional diagnostic role of 18F- PSMA PET /CT (sensitivity) in patients with prostate cancer with biochemical relapse compared to other diagnostic methods routinely used. The primary objective is to evaluate the sensitivity of 18F-PSMA PET/CT defined as the ratio between the number of 18F-PSMA PET/CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging.Patients enrolled in the study would benefit from a more accurate but above all earlier diagnosis of disease recurrence sites, thus being able to undergo targeted therapies, with a clear impact on the clinical management of the disease.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have histologically or cytologically confirmed prostate cancer
2. Male, aged \>18 years on the day of signing and dating the informed consent form.
3. Previous radical treatment for prostate cancer (radiotherapy or surgery)
4. Negativity of all the other traditional morphological and functional imaging or doubtful imaging of 18F-FMC PET/CT
5. Patients with PSA progression defined as PSA ≥ 0.2 ng/mL and PSA rising defined as 2 subsequent values showing PSA increase at least 1 week apart.
6. Male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
7. Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

1. Hormonotherapy in the last 6 months
2. No radiotherapy in the last 6 months.
3. Participation in another clinical trial with any investigational agents within 30 days prior to prior informed consent date
4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Study Agent.
5. Medical or psychological conditions that would not permit the subject to sign the informed consent
Evaluation of the French Translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) After Total PharyngoLaryngectomy

A monocentric study to evaluate the french translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) after Total PharyngoLaryngectomy

the SOAL questionnaire is a validated Patient Reported Outcomes (PRO) questionnaire in English language.

The aim of this study is to develop a new tool in french language and to evaluate incidence and the specific impact of swallowing disorders on the quality of life of patients after Total PharyngoLaryngectomy.

Eligibility Criteria:
Inclusion Criteria:

* Total PharyngoLaryngectomy
* Age ≥ 18 years old
* Read, write and understand the French language

Exclusion Criteria:

* Patient under guardianship, deprived of liberty, safeguard of justice
* Refusal to participate in research
Occupational Therapy Rehabilitation for Frail Elders with Dysphagia

The goal of this proof-of-concept study is to assess the potential of a newly developed intervention with combined skill- and strength-based principles for maximizing swallowing-related outcomes and prevent further weakening of the swallowing muscles in older people with dysphagia (difficulty swallowing).

The main questions to be answered are:

1. Does the intervention produce clinically significant improvement in ingestive skills during meals in older individuals with dysphagia?
2. Does the intervention produce clinically significant improvements in tongue strength and orofacial function in older persons with dysphagia?
3. Does the intervention produce clinically significant improvements in nutritional status and quality of life in older individuals with dysphagia?
4. Is there an association between perceived autonomy support and intervention engagement when older individuals with dysphagia receive the intervention during hospitalization and continued in community-based rehabilitation after discharge?

Participants will be asked to perform goal-directed and task-specific swallowing exercises in eating and drinking activities where the intensity variables include advancing steps of an altered bolus volume and consistency according to a 17-level task hierarchy, which are introduced according to predetermined progression rules, as well as increases in swallowing repetitions. The dosage is 2-3 individual, face-to-face therapy sessions per week for up to a maximum of eight weeks. A therapy session lasts up to 45 min. In between therapy sessions, participants integrate the achieved level from therapy into their daily meals as self-training.


Eligibility Criteria:
Inclusion Criteria:

* A score of 5-18 on the Gugging Swallowing Screen.
* Speaks and understands Danish.
* Are able to cooperate in the intervention and give written informed consent; i.e. is oriented in time, place and own data, and able to perform four simple oral motor movements on request.

  * Has given written informed consent.

Exclusion Criteria:

* Esophageal dysphagia.
* Progressive neurologenic dysphagia.
* Psychiatric illness.
* Delirious.
* Infections that requires isolation.
* Need for palliative care.
Cortisone Treatment for the Prevention of Postoperative Pancreatitis and Pancreatitis-induced Complications After Pancreaticoduodenectomy and Distal Pancreatic Resection

The purpose of this randomized, placebo-controlled trial is to investigate whether postoperative pancreatitis and other immediate complications after pancreaticoduodenectomy or distal pancreatic resection may be reduced with cortisone treatment. Treatment is administered to high risk patients (defined by high amount of acinar cells in the cut edge of pancreas).


Eligibility Criteria:
Inclusion Criteria:

* Pancreaticoduodenectomy and distal pancreatectomy patients in Tampere University Hospital

Exclusion Criteria:

* Patients with an ongoing cortisone treatment
* Cefuroxime allergy
* Chronic pancreatitis
Diagnostic Accuracy of Quantitative Neuropad Test for Diabetic Peripheral Neuropathy

This study aimed to evaluate the diagnostic vaule of quantitative Neuropad for diabetic peripheral neuropathy

This is a diagnostic study. Every patient will undertake Neuropad test, inculding the visual and quantitative screening tests. The visual screening test includes whether the Neuropad test paper changes completely from blue to pink within 10 minutes (visual screening test a) and the time to complete color change (visual screening test b). the quantitative screening test using a handheld color scanner to scan the rate of color change, which estimated by the slope of the Neuropad color change per minute. The visual and quantitative screening tests were compared when the Neuropathy Disability Score (NDS) and the Neurological Symptom Score (NSS) combined score as diagnostic criteria.

Eligibility Criteria:
Inclusion Criteria:

1) diagnosed type 2 diabetic patients; 2) age between 18 and 80 years.

Exclusion Criteria:

1) patients with type 1 diabetes, secondary diabetes, and patients with pre-existing diabetic foot; 2) exclusion of the following clinical conditions: foot skin lesions (scarring, rash, flaking skin, infection, etc. on the skin of the test site), peripheral arterial occlusive disease, long-term heavy smoking, chronic alcohol abuse, thyroid disease, liver insufficiency (more than 3-fold increase in liver enzymes), renal insufficiency (eGFR ≤ 30 mL /min/1.73m2), acute and chronic infections, cervical and lumbar spine diseases, bone and joint system diseases, other neurological diseases, autoimmune diseases, malignant tumors, psychiatric or psychological diseases, taking drugs that affect autonomic function, and combined with other diseases that can cause peripheral neuropathy; 3) those who cannot complete the experiment as required.
Clinical Study of Epoetin Beta to Chemotherapy-Induced Anemia (CIA) Patients

This is a study to investigate the clinical efficacy and safety of epoetin beta 36,000 IU compared with placebo when administrated subcutaneously (s.c.) once-weekly for 12 weeks to anemic patients with lung cancer or gynecologic cancer undergoing chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Lung cancer or gynecologic cancer patients
* Undergoing platinum-based chemotherapy repeated for ≧ 2 cycles after erythropoietin (EPO) or placebo administration
* 8.0 g/dL ≦ hemoglobin concentration (Hb) ≦ 10.0 g/dL
* 20 - 79 years old
* Performance status: 0 - 2
* No iron deficiency anemia

Exclusion Criteria:

* Red blood cell transfusion within 4 weeks before treatment
* Erythropoietin therapy within 8 weeks before treatment
The Effect of Antihypertensive Agents Concerning With Hemodynamics and Reduction of Anaesthetics in Orthognathic Surgery

For those who receive hypotensive anesthesia in orthognathic surgeries, the investigators premedicate with anti-hypertensive agent so that it decreases the occurence of tachycardia and the rebound hypertension due to hypotensive anesthesia, enabling us to compare hemodynamic stability and reduction of anesthetic agents during the operation.


Eligibility Criteria:
Inclusion Criteria:

1. ASA class I-II
2. obtaining written informed consent from the parents
3. aged 18-29 years who were undergoing orthognathic surgery.

Exclusion Criteria:

1. Hypertension patients with anti-hypertensive agents
2. chronic renal failure or End stage renal disease patients.
3. renal artery stenosis history.
4. Patients who are with medication due to systemic disease.
5. symptomatic asthma
6. Drug hyperactivity
7. neurological or psychiatric illnesses
8. mental retardation
9. patients who can't read the consent form due to illiterate or foreigner
Quality of Life and Fixed-ratio Combination of Insulin Degludec and Liraglutide (iDegLira)

This work is aimed at improving the quality of life of older patients affected by type 2 diabetes. The investigators will try to amiliorate the complexity of hypogliceamic treatment in a little group of older patients with type 2 diabetes reducing the number of pills and/or insulin administration using a single daily dose of a fixed combination of insulin degludec and liraglutide. This therapeutic semplification will be done indipendently of pre-existent glicaemic control.

Older patients with type 2 diabetes often have numerous coexisting medical problems for which these subjets prescribed multiple medications. Actually, diabetes, hyertension, cardiovascular diseases (CVDs), neurodegenerative diseases (NDDs), digestive and respiratory disorders are common in aged peolple and tend to coexist. Unfortunally, the complex therapy of these diseases increases the risk of adverse drug events. Furthermore, there is marked heterogeneity in health status and functional capacity in older diabetic subjects, often making prescribing decisions complex and challenging. On the other hand, despite of the use of many medicines, undertreatment is also frequent present in the elderly and the probability of underprescription increased significantly with the number of medicines.Both conditions have a detrimental effect on quality of life (QoL) of elderly subjects increasing the risk of disability and death. Therefore, older people should benefit greatly of a simplification of drug regimens and reduction of pill burdens as well as better explanations of the reason for the prescriptions. The combination of insulin degludec (100 units/mL) and liraglutide (3.6 mg/mL), termed IDegLira, was approved in 2014 for the treatment of type 2 diabetes inadequately controlled with oral glucose-lowering agents alone or in combination with a GLP-1 receptor agonist or basal insulin (European indication). Interestingly, RCTs and real-world evidence provided insights into effectiveness and safety in routine clinical practice. However, beyond its known metabolic efficacy IDegLira has a very small hypoglicaemic rate, with a single daily and flexible administration dose and a very good safety profile that makes it suitable for fragile diabetic old patients.

Eligibility Criteria:
Inclusion Criteria:

* frail very old type 2 diabetes patients without severe cognitive impairment and/or grave depression with 3 or more daily hypoglycaemic drug administrations

Exclusion Criteria:

* e-GFR \< 15 ml/min
* any experimental clinical trial participation or every experimental drug use in the previous 6 months before commencing this study
* every know or suspected allergic reaction to deglutec or any other GLP-1 agonist
* any known contraindication to IDegLira use (as described in product characteristics)
* Recent cancer diagnosis (\<3 y) or active radio- or chemo-therapy. Cancer diagnosis older than 3 years before commencing the study is allowed
* Mini mental state examination score lower than 14/30 and/or Activity Daily Living score lower than 1/6 and/or Instrumenctal Activity Daily Living lower than 1/8
Translation and Validation of the French Quality of Recovery (QoR-15) Questionnaire - Postoperative Recovery Assessment Questionnaire

Surgery (under general anaesthesia or under loco-regional anaesthesia) is an event that causes stress, anxiety, pain and even minor complications such as nausea or vomiting. Peri-operative management and the psychological support allocated to each patient will have an impact on the hospitalization experience. Many studies have focused on reducing peri-operative mortality (decrease in pain intensity as measured by analog visual scale, decrease in nausea/vomiting frequency, decrease in remobilization time, etc.) but few assessed the overall recovery of patients. there is a desire to improve physical and psychological recovery, with particular attention to the patient's own feelings. It is essential to evaluate our peri-operative management practices based on patient-centred criteria. In this context, the development of a scale for measuring the quality of post-operative recovery appears to be necessary. In 2013, a questionnaire was quickly run (about 2-3 min): the QoR-15 was validated. This questionnaire is reliable, sensitive, easily achievable in clinical practice, not onerous for the patient and provides information on the post-operative recovery perceived by the patient himself.

The QoR-15 was validated in English, then in Danish, Chinese, Portuguese and more recently in Swedish. It has not yet been validated in French and therefore cannot be used in studies on francophone patients.

Investigator goal is to validate a French version of the QoR-15, the FQoR-15.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years old or older)
* Francophones;
* Admitted for any type of scheduled surgery;
* Able to complete the questionnaire upon admission, alone or with the assistance of a third party;
* Agreeing to participate in the study.

Exclusion Criteria:

* Psychiatric or neurological pathology compromising cooperation in the validation protocol of the questionnaire;
* Hospitalized for intracranial surgery
Lung Diffusing Capacity for Nitric Oxide and Carbon Monoxide Early After Mild-to-severe COVID-19

Infection with severe acute respiratory syndrome-CoV-2 (SARS-CoV-2) may be associated with diffuse alveolar damage and pulmonary vasculitis. Thus, it is likely that pulmonary function changes may be seen in COVID-19 survivors. The aim of the present study was to test that simultaneously-determined lung diffusing capacity for nitric oxide and carbon monoxide may be useful to detect post-viral diffusive gas exchange abnormalities early after mild-to-severe COVID-19-related pneumonias.

Infection with severe acute respiratory syndrome-CoV-2 (SARS-CoV-2) may be asymptomatic or associated with life-threatening interstitial pneumonia. Clinically, patients affected from severe coronavirus disease-19 (COVID-19) are described as exhibiting rapidly progressing acute respiratory failure with unusually low oxygen levels in arterial blood. On computed tomography scans, diffuse, peripheral "ground glass" opacities of the lung are seen while autopsy lung specimens showed diffuse alveolar damage and capillary endothelialitis.

The objective of the current study, conducted in patients who had recovered from mild-to-severe COVID-19 illness, was to test that simultaneously-determined lung diffusing capacity for nitric oxide (NO) and carbon monoxide (CO) may be of great use to early detect post-infective diffusive gas exchange abnormalities. More specifically, we hypothesized that measurement of membrane diffusive conductance for CO and pulmonary capillary volume may provide accurate information on residual changes of peripheral gas exchanging units of the lung related to previous SARS-CoV-2 infection.

Eligibility Criteria:
Inclusion Criteria:

* subjects were selected after two nasopharyngeal swabs negative for SARS-CoV-2

Exclusion Criteria:

* severe comorbidities potentially affecting pulmonary gas exchange
N-acetylcysteine for the Treatment of Cannabis Dependence: Working Mechanisms

This study investigates the effects of repeated NAC administration on glutamate concentrations in the anterior cingulate cortex (ACC), on neurocognitive functioning, and on neuro-inflammatory parameters in adult cannabis-dependent individuals.


Eligibility Criteria:
Inclusion Criteria:

* Current DSM-IV diagnosis of cannabis dependence, \>1 week detoxified and abstinent;
* Able to provide written informed consent and to comply with study procedures.
* Dutch speaking (Dutch as primary language).

Exclusion Criteria:

* Currently dependent on any substance other than cannabis, alcohol or nicotine;
* History of any major internal disease (including diabetes, cardiovascular disease, lung disease, liver or kidney disease);
* An active or any history of neurological disorder, including but not limited to seizure disorder, epilepsy, stroke, neurological disease, cognitive impairment, head trauma with prolonged loss of consciousness (\>10 minutes), or migraine headaches;
* An active or a history of a psychiatric disorder including, but not limited to, depression, schizophrenia, bipolar disorder, anxiety, or other psychiatric disorders;
* Asthma;
* Known hypersensitivity or allergy to n-acetylcysteine, or receiving chronic therapy with medication that could interact adversely with n-acetylcysteine within 30 days prior to randomization (i.e., nitroglycerin, ACE inhibitors or antihypertensive drugs, anti-coagulants);
* Exclusion criteria for MRI: having metal in the body and/or having claustrophobia
Measles Vaccine in Patients With Measles Virus-Positive, Advanced Non-Small Cell Lung Cancer

The objectives of the study are to assess the efficacy and safety of live, attenuated measles vaccine as consolidation therapy in patients with measles-positive, non-small cell lung cancer with locally-advanced (stage 3B with pleural effusion) or metastatic (stage 4) tumors in remission.

This is a single-institution, non-randomized phase 1/2 study in patients with locally-advanced or metastatic NSCLC in remission after receiving standard systemic chemotherapy of four cycles of combination chemotherapy consisting of four cycles of cisplatin combined with vinorelbine.

Eligibility Criteria:
Inclusion Criteria:

* Patients in remission after first-line chemotherapy

Exclusion Criteria:

* Progressive disease
Multimodal Noninvasive Assessment of Peripheral Circulation in Chronic Limb-threatening Ischemia

Assessment of a novel diagnostic method for screening and diagnosing chronic limb-threatening ischemia (CLTI). Using hyperspectral and thermal imaging, the perfusion and oxygenation in the lower limbs will be studied in healthy and unhealthy individuals.


Eligibility Criteria:
Inclusion Criteria:

* for CLTI patients age \>50
* for age control group age \>50 and not diagnosed with cardiovascular diseases. 0.9 \< ABI \< 1.3
* for healthy group 18 \<= age \<= 50 and no history of cardiovascular disease
* volunteering for study

Exclusion Criteria:

* inability to give informed consent
* denial