cyrilzakka/clinical-trials huggingface dataset:
99mTc-H7ND SPECT/CT Imaging in NSCLC

To study the clinical application of 99mTc-H7ND SPECT/CT imaging in the efficacy evaluation and prediction of non-small cell lung cancer (NSCLC)

This study was a prospective, controlled, single-center clinical study.

To evaluate the value of 99mTc-H7ND imaging in the evaluation of stable disease in patients with non-small cell lung cancer (NSCLC) assessed by RECIST1.1, and to predict the efficacy of subsequent treatment (second-line treatment).

Patients with NSCLC confirmed by cytology or pathology, who were unable to undergo radical surgery because of recurrence, metastasis, or their own conditions, and who had completed 2-4 cycles of first-line therapy and had RECIST1.1 assessment (SD) were divided into 2 groups:

Experimental group: 99mTc-H7ND SPECT/CT imaging performed Control group: 99mTc-H7ND SPECT/CT imaging was not performed

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged from 18 to 80 years old;
2. patients with NSCLC confirmed by needle aspiration cytology or surgical pathology, who cannot undergo radical surgery due to recurrence, metastasis or patient's own conditions;
3. Has completed 2-4 cycles of first-line therapy (including chemotherapy, immunotherapy, chemotherapy combined with immunotherapy, chemotherapy combined with targeted therapy, etc.), and has SD assessed by RECIST 1.1 during the same period;
4. Patients had at least one measurable lesion;
5. No local radiotherapy for primary or metastatic lesions within 28 days;
6. ECOG score 0-2;
7. Expected survival time ≥3 months;
8. Voluntarily participate and sign informed consent.

Exclusion Criteria:

1. Women who plan to become pregnant within 6 months, or are pregnant or lactating.
2. Patients with severe brain or bone metastases;
3. Severe anemia and severe liver and kidney damage;
4. Pathological or long-term follow-up results may not be available;
5. The relevant control imaging data and clinical data were not available;
6. Severe illness is difficult to cooperate (such as acute cardiovascular and cerebrovascular events or serious cardiovascular diseases);
7. Received any surgery or invasive treatment or procedure within 4 weeks before enrollment;
8. Cannot tolerate standard second-line therapy or other first-line therapies.
9. Known allergy to 99mTc-H7ND or any of its components; He had a history of severe allergies;
10. Protocol imaging contraindications were present;
11. The investigator considered it inappropriate to participate in the study.
Cardiac Changes in Early Parkinson's Disease: a Follow Up Study

The purpose of this study is to investigate the long-term effects of treatment with the adrenergic blocker carvedilol on serial DaTscan, a dopamine transporter (DAT) single photon emission computerized tomography (SPECT) imaging technique in a population of subjects with defined pre-motor Parkinson's disease risks (i.e., REM sleep Behavior Disorder (RBD) and at least one among hyposmia, constipation, depression and color vision abnormality) and abnormal 123I-Metaiodobenzylguanidine (MIBG) scintigraphy.

Primary procedures in this study are MIBG scan, DAT scan, Neuromelanin Magnetic Resonance Imaging (NM-MRI), and carvedilol treatment. Subjects will return for research visits and imaging tests every six months for three years. We hypothesize that the rate of decline in DAT scan123I-Ioflupane uptake will be slower in subjects who have received the adrenergic blocker carvedilol, resulting in a decreased clinical phenoconversion rate to parkinsonism. If this is true, it might create a considerable window of opportunity for treatment with adrenergic blockers - or similar compounds able to reduce Sympathetic Nervous System (SNS) hyperactivity - which may result in long-term benefits such as delaying the neurodegenerative process and the onset of neurological symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the study "The Effect of Adrenergic Blocker Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's Disease" (Pro#00053136)
* Capacity to give informed consent

Exclusion Criteria:

* Secondary Parkinsonism, including tardive
* Concurrent dementia defined by a score lower than 22 on the MoCA
* Concurrent severe depression defined by a BDI fast screen score greater than 13
* Comorbidities related to SNS hyperactivity

  * Heart failure (LVEF \<45%)
  * Recent myocardial revascularization (\<12 weeks)
  * Hypertension (SBP\>150mmHg or DBP\>100mmHg)
  * Chronic Atrial fibrillation
  * Concurrent Use of Beta-adrenergic antagonist
  * Diabetes mellitus
  * COPD
  * Untreated Sever Sleep Apnea; Apnea-Hypopnea Index (AHI) \> 30/h.
  * Severely reduced kidney function (Glomerular Filtration Rate\<30ml/min)
* Contraindications to the use of carvedilol

  * Asthma or bronchospasm
  * Recent myocardial infarction (\<48 h)
  * Ongoing unstable angina
  * Cardiogenic shock or prolonged hypotension
  * Second or Third-Degree AV block
  * Significant valvular aortic stenosis
  * Obstructive cardiomyopathy, or constrictive pericarditis
  * Resting Heart Rate (RHR)\< 45 Or Bradycardia (HR\<60) with at least one of the following symptoms; Lightheadedness, dizziness, weakness, Altered mental status, Shortness of breath, Pre-Syncope, Syncope, Sick Sinus Syndrome, Stroke within the past 1 month, Severe Hepatic Dysfunction
* Allergy/hypersensitivity to iodine or study medication
Incidence of Short Sublingual Frenulum in Newborns at the Hospital Nostra Senyora de Meritxell.

The aim of the study was to analyze the incidence of short sublingual frenulum in newborns of the Hospital Nostra Senyora de Meritxell of the Principat of Andorra.

Thus, the objective of this study was to determine the incidence of AG in newborns of the Hospital Nostra Senyora de Meritxell of the Principat of Andorra, as well as the relationship with auxological data, associated malformations or diseases and hereditary component of the newborn.

A random sample of 2167 individuals is enough to estimate, with a confidence of 95% and an accuracy of +/- 1 percentage units, a population percentage that is projected to be around 6%. The percentage of replenishment required is projected to be 0%. With this sample, it will be sufficient to estimate the children who have ankyloglossia, the % of relatives who also have it (a population percentage that is projected to be around 25%). Confidential and anonymous collection of data from patients' medical records for a period of 2 years and 8 months, and write them down in a database to finally correlate them and see if there is any association with the parameters studied.

Eligibility Criteria:
Inclusion Criteria:

- The inclusion criteria are patients born from July 2018 to February 2021 (both inclusive) and of both genders.

Exclusion Criteria:

* The exclusion criteria are all those who were born abroad and who after 24 hours go to the Hospital of Andorra, those urgently transferred to other foreign centers after birth, as well as those who present medical records with lack of information.
Ethosuximide and Pentoxifylline in the Treatment of Abdominal Pain Related to Irritable Bowel Syndrome

Ethosuximide and pentoxifylline in the treatment of abdominal pain related to irritable bowel syndrome

Ethosuximide and pentoxifylline in the treatment of abdominal pain related to irritable bowel syndrome: Does this add to current treatment?

Eligibility Criteria:
Inclusion Criteria:

* • Age ≥ 18 years,

  * Man and Women, Negative pregnancy test and effective contraception,
  * IBS defined by the Rome criteria IV
  * During the previous seven days the inclusion visit, average numeric rating scale (NRS) pain ≥ 4.
  * IBS Treatment stable for 1 month

Exclusion Criteria:

* • Breastfeeding

  * Diabetic patients
  * Significant liver function abnormalities (transaminases\> 3N, cholestasis) and moderate renal disease (MDRD \<60 ml / min)
  * Addiction to alcohol and / or drugs,
  * Antiepileptic drugs taken (epilepsy or chronic pain)
  * Chronic pain of greater intensity than that related to IBS,
  * Known Allergyto succinimides (ethosuximide, methsuximide, phensuximide) and pentoxifylline.
  * History or current severe depression (hospitalization, long-term antidepressant treatment)
  * Psychotic disorders,
A Pilot RCT to Improve Cognitive Processing Speed in Acute SCI

This study seeks conduct a pilot study to test whether a cognitive training program can improve processing speed abilities in individuals with acute traumatic spinal cord injury.

Spinal cord injury (SCI) newly affects approximately 18,000 persons in the US per year. Decades of research have focused on the physical limitations associated with SCI, as well as therapies for addressing these physical problems. However, it is becoming better acknowledged that many individuals experience significant problems with their cognitive abilities, such as attention, memory, and the time it takes them to process information. Research has shown that people who have cognitive difficulties, compared to those with a purely physical disability, are less likely to be employed, engage in fewer social and work-related activities, have greater difficulties carrying out routine household tasks, and are at higher risk for mental illness. If cognitive issues arise after an SCI, it is more likely that a person would have a more challenging time adapting the many lifestyle changes brought about by their injury, would benefit less from their rehabilitation program, and have more difficulty rejoining the workforce. As it stands, cognitive assessment or rehabilitation is not part of the standard of care for individuals after their SCI because of the relative lack of research in this area. This study seeks conduct a multisite pilot study to test whether a cognitive training program can improve processing speed abilities in individuals shortly after they experience their SCI, with the hopes that this early intervention will improve the trajectory of their overall health and well-being.

Eligibility Criteria:
Inclusion Criteria:

* 18-59 years old
* recent traumatic SCI (approximately 6 months post-injury)

Exclusion Criteria:

* no other significant neurological, psychiatric or substance use history
* no significantly impairing visual disturbance
Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma

To study the efficacy of Alimta as a single agent in thymic cancers

The broad range of clinical activity of thymic carcinomas makes the likelihood of detecting efficacy of a single agent such as premetrexed a reasonable objective since these malignancies are relatively slow growing and exhibit a broad range of chemosensitivity to antineoplastic agents.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed invasive, recurrent or metastatic thymoma or thymic carcinoma not amenable to potentially curative therapy by surgery. Original biopsy of tumor is sufficient for diagnoses unless otherwise clinically indicated.
* Patients must have measurable disease with at least one bidimensional measurable lesion. Any scans or x-rays used to document measurable disease must be obtained with 6 weeks prior to registration.
* Patients may have had prior chemotherapy for metastatic disease
* Adequate organ function as defined by: bili \</=1.5; calc. crt clr of \>/=45; hematologic-granulocytes \>/=1500 \& plt \>/=100K.
* Patients who are receiving a stable dose of corticosteroids for myasthenia gravis are eligible.
* ECOG performance status of 0 or 1

Exclusion Criteria:

* Acute intercurrent infection or complications
* pregnancy or lactating patients
* Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents.
* Presence of clinically relevant third-space fluid collections that cannot be controlled by a procedure
Clinical Evaluation of Bass and Treble Controls for CI Subjects

The clinical study is designed to evaluate the safety and effectiveness of recipient controlled Bass and Treble.

Bass and Treble controls provide the CI recipient with access to the adjustment of low and high frequency sound balance, known as Bass and Treble respectively. The clinical study is designed to evaluate the safety and effectiveness of recipient controlled Bass and Treble.

Subjects will have access to the Bass and Treble controls during a 4 week take-home period, and will complete questionnaires and diaries to provide descriptive data on the Bass and Treble adjustments made during take home use, and the success of these adjustments.

Pre and post intervention speech test results will be used to evaluate the effect of access to Bass and Treble controls on speech perception. The post intervention questionnaire will provide information on the overall ratings of the Bass and Treble controls.

Eligibility Criteria:
Inclusion Criteria:

1. Six years of age or older
2. At least 3 months experience with the CP810, CP910 or CP920 sound processor
3. At least 3 months experience with the CI24RE or CI500 series implant
4. Willingness to participate in and to comply with all requirements of the protocol

Exclusion Criteria:

1. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device
2. Additional disabilities that would prevent participation in evaluations
Spirituality, Experience of Disease and Quality of Life in Cancer Patients

The general aim of research is to identify and analyze the impact and role of spirituality (as a search for meaning and understanding of the meaning of existence) in the experience of cancer. For this purpose, the main objective of this study is to measure the "existential" component in the trajectory of the disease. It is a question of observing its potential contribution to the improvement of the quality of life of the patients and to define if this variable can be translated into a strategy of adjustment for the patients. This research has a double interest: (a) clinical interest in better managing patients' needs; (B) an interest in research in the field of health by combining a measure of spirituality with other psycho-social variables.

The project is a prospective non-randomized mono-centric study by questionnaire and research interview. It is a study that seeks to identify the role of spirituality in the experience of illness (i.e. representations, adjustments, emotional distress) and as a determinant of the quality of life of subjects with cancer pathology.

The interviews will be conducted by a psychologist to qualitatively collect the elements of the lived experience of the disease in connection with the spiritual elements of the "quest for meaning" type.

The population covered by the project is in and out patients coming to the Department of Medical Oncology and Palliative Care at the CHU de la Timone.

The realization of this project will allow investigators to explore the specificity of the existential / spiritual dimensions of patients confronted with cancer, to assess the patients' needs for this type of approach within the hospital, to link the existential component / Spiritual with psycho-social variables


Eligibility Criteria:
Inclusion Criteria:

* patient undergoing chemotherapy

Exclusion Criteria:

* patient presenting psychiatric or neurological disorders
Open Label, Safety Study of EN3270 in Patients With Moderate to Severe Non-malignant, Chronic Pain

Two stage study looking at different titration schedules in patients with moderate to severe non-malignant chronic pain. Up to 80 patients at approximately 15 centers in the US to be enrolled. Study participation is approximately 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Opioid experienced
* Hx (min 3 months) of moderate to severe pain of non-malignant that is well controlled with current pain therapy
* On a stable dose of opioid medication for greater than or equal to 14 days
* Have an adequate personal support system including a co-habitant
* Are able and willing to follow verbal and written instructions and provide written informed consent

Exclusion Criteria:

* Are pregnant or lactating
* Have pain secondary to a confirmed or suspected neoplasm
* Have a history or physical examination finding incompatible with safe participation in the study
* Have a history of alcohol or drug abuse
* Have a history or physical examination finding of clinically significant skin abnormalities that would preclude use of a transdermal patch (e.g., psoriasis)
* Have a history of or currently manifesting a clinically significant psychiatric disorder
* Have a known history of allergy that negatively impacts respiratory function to a clinically significant level
* Plan to have an MRI while on the study
* Have any clinically significant condition that would, in the opinion of the investigator, preclude safe study participation
* Are scheduled for surgery requiring general anesthesia within the study period
Magnesium and Dexmedetomidine in Pheochromocytoma

Anesthesia management of pheochromocytoma excision surgery is associated with severe hemodynamic fluctuations.The objective of this study was to compare the hypertensive episodes requiring sodium nitroprusside administration between the group treated with magnesium-dexmedetomidine and conventional group in pheochromocytoma.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists classification (ASA) 1-3
* high urinary catecholamine or metabolites
* tumor sizes \< 5 cm
* body mass index (BMI) \<35 kg/m2

Exclusion Criteria:

* open surgery
* bilateral masses
* tumor larger than 5 cm
* incomplete data
Tissue Therapy of Transsphincteric Anal Fistula

This clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.

After being informed about the study and potential risks, all patients giving written informed consent will undergo screening serology and preoperative work-up to determine eligibility for study entery. Patients who meet the eligibility requirements will be treated for their fistulas by combined minor surgical debridement of the fistula tract and closure of the internal orifice as well as liposuction from the abdominal wall. Regenerative cells- enriched lipoaspirate will be injected around the entire length of the fistula tract. The first five patients will receive their own regenerative cells and act as donors for the next included patients, but they will not be included in the final analysis. The rest of the included patients (70) will be randomized in double-blinded manner (participant and investigator) in a 1:1 ratio to either recieve own regenerative cells (ADRC Adipose-Derived Regeneative Cells) or donated cultured regenerative cells (ADRC001). All included patients will be scheduled for follow-up at 3, 6 and 12 months after treatment.

Eligibility Criteria:
Inclusion criterion:

Adult patients (\>= 18years) with complex anal fistula (high transsphincteric or suprasphincteric), with involvement of more 30% of the anal sphincter referred to the surgical department at Odense University Hospital for treatment, and who are:

* able to communicate with Danish language
* able to provide informed consent
* having address in the region of southern Denmark during the study

Exclusion criteria:

1. Signs of suppuration/cavitation around the fistula
2. Simple or low anal fistula, which can be treated by simple surgical incision
3. Ano-vaginal and recto-vaginal fistula
4. The presence of more than one fistula tract, more than two external orifices or more than one internal orifice
5. Inflammatory Bowel Disease
6. Immunosuppression (due to clinical condition or medical therapy)
7. Malignancy within 5 years
8. Previous radiotherapy of the abdomen and pelvis
9. BMI under 18.5
10. Allergy against the antibiotics: Penicillin and streptomycin.
11. Coagulopathy
12. Pregnancy and lactation (positive HCG (human chorionic gonadotropin) test)
13. Verified syphilis, HIV, or hepatitis on screening test
Study for Multiple Doses of HM15136(Efpegerglucagon) in Obese or Overweight Subjects With Comorbidities

The planned period of each cohort is 22 weeks including subject screening, treatments for 12 weeks, and follow up period.

The current Phase I study was a two-part study. Part 1 was designed to assess the safety, PK, and pharmacodynamics (PD) after repeated doses of HM15136 in obese or overweight subjects with comorbidities (i.e., dyslipidemia and/or hypertension). Part 2 was designed to assess the safety, PK, and PD after repeated doses of HM15136 in obese or overweight subjects with T2DM and comorbidities (i.e., dyslipidemia and/or

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female subjects
2. Age ≥ 18 to ≤ 65 years at Screening visit
3. Body Mass Index ( BMI ≥ 30 kg/m 2 or 27 kg/m 2 with presence of comorbidities (Subjects in Part 1 and Subjects with Pre diabete s mellitus (DM) in Part 2: dyslipidemia and or hypertension except for Type 2 (T2) DM, T2DM subjects in Part 2: dyslipidemia and/or hypertension with T2DM) with/without medication treatment and have had stable weight for 3 months (weight changes less than 5%)

Exclusion Criteria:

1. Previous surgical treatment for obesity (bariatric surgery, gastric banding, etc.) or any other gastrointestinal surgery that may induce malabsorption, history of bowel resection \> 20 cm, any malabsorption disorder, severe gastroparesis, any GI procedure for weight loss (including LAPBAND®), as well as clinically significant gastrointestinal disorders (e.g. peptic ulcers, severe GERD ) at Screening.
2. Use of antacids, anticoagulants, or drugs that directly modify gastrointestinal (GI) motility, including antacid s anticholinergics, anticonvulsants, serotonin type 3 (5HT3) antagonists, dopamine antagonists, opiates; anticoagulation within 2 weeks of screening (But, it is not limited to the above listed drugs.)
3. Uncontrolled hypertension, defined as systolic blood pressure \> 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at screening independent of subjects being on antihypertensive medication or no t). But, if the results are out of the reference range at the screening visit, they can be tested again on another day. Subjects with uncontrolled hypertension may be rescreened after 3 months, following initiation or adjustment of antihyp ertensive therapy.)
Effect of Normal Aging on Language Processing

The purpose of this study is to understand the effect of age on language abilities. The investigators aim at investigating the cerebral modifications that take place in normal aging, at the functional an anatomical level.


Eligibility Criteria:
Inclusion Criteria:

* Age of 30 years and above
* Right handed
* French native speakers
* Affiliation to French social security (Sécurité Sociale)
* Medical interview
* Consent form signed

Exclusion Criteria:

* Cerebral or respiratory pathologies
* Any MRI contrindication