cyrilzakka/clinical-trials huggingface dataset:
tDCS and Cognition in Adults With Multiple Sclerosis or Encephalitis

This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain mental abilities in individuals with multiple sclerosis (MS) or encephalitis. Participants will be asked to come in daily for two full weeks during which time participants will undergo cognitive testing and Magnetic Resonance Imaging (MRI) brain scans. In this research, a very weak electrical current is administered to the surface of the scalp while participants complete cognitive tasks. The investigators' aim is to find out whether tDCS will improve task performance in adults with multiple sclerosis or encephalitis.

Participants enrolled into this study may be asked to do the following:

* Come to the investigators' testing office at the Johns Hopkins Hospital where the tDCS equipment is located for 10 study visits.
* Grant permission for the researchers to view medical records associated with the participant's diagnosis of multiple sclerosis or encephalitis (if applicable) and general state of health.
* Complete a questionnaire and provide a health history in order to verify eligibility to participate and be able to safely undergo the experimental procedures.
* Complete several computerized, written, and/or aural tasks (i.e., saying words out loud) that assess different cognitive functions such as attention, memory, language, or processing speed.
* Wear electrodes that will be placed on the scalp with a large rubberized band. These electrodes will administer very weak electrical current (tDCS) for 30 minutes.
* Participate in several study conditions. The exact conditions and the order will be randomized. That is, the conditions and order will vary by chance (like the flip of a coin). Under some conditions, the participant might receive active stimulation (tDCS) and under other conditions, the participant might receive placebo (or sham) stimulation. Placebo stimulation is similar to active tDCS but lasts only a few seconds. However, all groups will wear the electrodes for the same length of time to prevent the participant from knowing whether participants are receiving active tDCS or sham stimulation. The study doctor and research staff will know which group the participant is in.
* Permission to audio and/or video-tape test sessions for later scoring and observation. These tapes will not be viewed by anyone not affiliated with the study without the participant's consent.
* Have structural, resting-state and functional Magnetic Resonance Imaging scans as a part of the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple sclerosis or encephalitis
* Over the age of 18

Exclusion Criteria:

* A diagnosis of schizophrenia bipolar disorder
* Beck Depression Inventory-II scores over 20
* Mini Mental Exam below 24
* Any uncontrolled seizure disorder
* Any implanted metal device or hearing aids
* Use of medication shown to interact with tDCS effectiveness
Treatment of Renal Colic in the Emergency Departement (ED).

to evaluate the analgesic effect of a standard dose of intravenous magnesium added to intramuscular diclofenac compared to intravenous lidocaine combined to intramuscular diclofenac or intramuscular diclofenac alone in patients presenting to the emergency department with renal colic and whether it can reduce opioid consumption.

Magnesium (MgSO4) is a N-Methyl-D-aspartate (NMDA) receptor antagonist and is thought to be involved in the modulation of pain. There has been little direct evidence that MgSO4 relieve neuropathic pain and prevents opioid-induced hyperalgesia in humans.

Intramuscular Diclofenac seems to offer the most effective sustained analgesia for renal colic in the ED and has few side effects.

Lidocain became the agent of choice in visceral and central pain. Intravenous lidocain is effective in the management of neuropathic pain such as diabetic neuropathy, post-surgical pain, post herpetic pain, headaches, and neurological malignancies. At low doses, lidocain is known a relatively safe medication. Lidocain seems an effective treatment who can be administrated in the renal colic.

Objective of study :

The aim of this study is to evaluate the analgesic effect of a standard dose of intravenous magnesium added to intramuscular diclofenac compared to intravenous lidocain combined to intramuscular diclofenac or intramuscular diclofenac alone in patients presenting to the emergency department with renal colic and whether it can reduce opioid consumption.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent.
* Age \> 18years.
* Confirmed renal colic
* With moderate to severe pain (visual analogic Scale ≥4).

Exclusion Criteria:

* Current regular use of analgesics, anticonvulsants, or antidepressants.
* Analgesia taken within 24 hours .
* Renal disorder with a low glomerular filtration rate (\< 60ml/min)
* Neuromuscular disorder.
* Severe cardiac disease.
* Pregnant women
* Contraindication to one of the protocol treatment
* Inability of the patient to cooperate
* Allergy to NSAID or lidocaine.
C11 AMT Positron Emission Tomography (PET) Imaging in Patients With Metastatic Invasive Breast Cancer

The purpose of this research project is to create images of where and how the amino acid (the building blocks of proteins)Tryptophan is processed in normal and abnormal tissue in the patient's body. Tryptophan is a normal building block of proteins in the body. Sometimes in the case of cancer and other diseases, Tryptophan is processed abnormally, and possible treatments for this abnormality are of great interest because of the potential to improve cancer care.

Coordinating Center: Southeast Phase 2 Consortium (SEP2C), Moffitt Cancer Center.

Research participation involves up to three experimental imaging examination visits in radiology: a baseline before the patient starts a cancer treatment, a follow-up a few days later, and a later follow up to see how the treatment may affect normal or abnormal processing of Tryptophan.

The research imaging results will be linked with other evidence of the patient's disease, but will not effect their care.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be enrolled on the NCI 8461/MCC 16025 study.
* Consent for participation in this companion imaging study and be able to successfully complete a minimum of two AMT PET/CT scans.

Exclusion Criteria:

* Patients must not meet any of the exclusion criteria for the NCI 8461/ MCC 16025 study.
* Not have any medical conditions prohibiting the successful completion of a minimum of two AMT PET/CT scans.
Program of Evaluation and Geriatric Intervention on the Functional Status, Quality of the Life, and Survival

Acute myeloid leukaemia (AML) is a disease of the elderly, with a median age at diagnosis of 65. A poor outcome in this population has been well established, with very short overall survival (OS) and disease free survival (DFS).There are numerous bad prognostic factors related to the disease itself or to the patient's medical condition.

This study will evaluate the impact of a Comprehensive Geriatric assessment (CGA) performed at diagnosis with planned interventions according to disabilities and monthly follow-up by a nurse practitioner during 6 months on functional status of older cancer patients treated for Acute myeloid leukaemia. Functional status will be assessed with the Lawson Instrumental Activities of Daily Living (IADL) scale at diagnosis and 6 months after randomisation.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 70 years and older
* Referred for treatment following a diagnosis of acute myeloid leukaemia.
* signed informed consent

Exclusion Criteria:

* Terminal patients, with a life expectancy estimated to be less than 3 months, will be excluded from the study, due to ethical issues and the fact that they are unlikely to benefit from this evaluation.
* Patients unable to give informed consent.
Everolimus Modulation of Anti-tumor T CD4 Immune Responses

Everolimus is an inhibitor of mammalian target of rapamycin, approved in patients with metastatic renal cell carcinoma.

The objective of this study is to investigated the influence of everolimus immune modulation on antitumor efficacy .


Eligibility Criteria:
Inclusion Criteria:

* Performance status ECOG-WHO 0, 1 or 2
* Metastatic renal cancer
* Patient candidate to everolimus treatment
* signed written informed consent
* fertile women with adequate contraception during the study and until 8 weeks after stopping treatment

Exclusion Criteria:

* Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)
* History of immune deficiency
* Hypersensitivity against rapamycin and derived
* Prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 5 years
* Active autoimmune diseases, HIV, hepatitis C or B virus
* Patients with any medical or psychiatric condition or disease,
* Patients under guardianship, curatorship or under the protection of justice.
Evaluation of Ronnie Gardiner Method in Individuals With Parkinson's Disease

Parkinson's disease (PD) is typically associated with cognitive and movement related functional disabilities. One commonly described cognitive complaint is the ability to do several things simultaneously, defined as dual or multiple tasking. The Ronnie Gardiner Method (RGM) is a rhythm and music based rehabilitation intervention that includes components that will train this ability specifically in addition to postural control, motor learning, movement ability and general cognitive function. The aim with the present randomized controlled single-blinded trial is to evaluate the RGM with main focus on dual-task performance, compared to a control group, in individuals with PD. The control group will continue with everyday activities, including ordinary exercise activities, with no additional activity. Both groups will be evaluated pre-, post-, and after 3 months post intervention. Following outcome measures will be analyzed:

1. dual task performance (motor-motor, and motor-cognitive)
2. level of physical activity, motor function and balance
3. cognitive function including memory and spatial function
4. health-related quality of life, fear of falling, and freezing of gait
5. qualitative interviews from focus group discussions

Patients with Parkinson's disease at the neurological department of University Hospital of Linköping are included and randomized to either the rhythm and music based rehabilitation method Ronnie Gardiner Method or to a control group with no other activity other than everyday activities including habitual exercise. Timed Up and Go (TUG) cognitive and TUG manual will be used to evaluate dual-task performance. The intervention will take place twice weekly for twelve weeks in a neurological rehabilitation facility, and will be led by a highly skilled physiotherapist with ten years of practice from the Ronnie Gardiner Method.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease, stage 1,5 to 4 on the Hoehn \& Yahr scale, community dwelling, stable medication, being able to walk at least 10 meters, being able to transport to the intervention facility, being able to follow instructions in Swedish

Exclusion Criteria:

* parkinsonism of other origin, color blindness, severely impaired vision or hearing
Simplus and Eson Non-Invasive Ventilation (NIV) Evaluation - Germany

This investigation is designed to evaluate the performance, comfort and ease of use of the Simplus and Eson masks amongst NIV patients who are currently on Bi-level therapy

Up to 40 NIV patients who currently use a full face mask or a nasal mask will be recruited. They will be issued a Simplus (if they are existing full face users) or Eson (if they are existing nasal users) to use in-home for 2 weeks. This will consists of male and female participants who have been prescribed with NIV therapy for at least 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18+
* Existing full face mask user or a nasal mask user
* Prescribed NIV therapy for at least 3 months

Exclusion Criteria:

* Inability to give informed consent
* Pregnant or think they may be pregnant
* Anatomical or physiological conditions making NIVtherapy inappropriate
* Patients who are in a coma or decreased level of consciousness
* Existing Simplus and Eson users
64Cu-SAR-bisPSMA for Identification of Participants With Recurrence of Prostate Cancer (COBRA)

The aim of this study is to determine the safety and efficacy of 64Cu-SAR-bisPSMA and determine the ability of 64Cu-SAR-bisPSMA Positron emission tomography (PET)/computed tomography (CT) to correctly detect the recurrence of prostate cancer in participants with biochemical recurrence of prostate cancer following definitive therapy.

Participants with biochemical evidence of recurrence of PC were evaluated with 64CU-SAR-bisPSMA PET/CT (Day 0 and Day 1) and by conventional methodologies up to 180 days later, eg. Histopathology/biopsy, conventional imaging, PSA reduction post focal salvage therapy or radiotherapy with no concomitant androgen deprivation therapy. Three independent central readers blinded to the participant number, the time of the PET/CT scan and the results of the conventional methodologies assessed the 64Cu-SAR-bisPSMA PET/CT. Three separate independent readers assessed the results of the conventional methodologies.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age.
2. Signed informed consent.
3. Life expectancy ≥ 12 weeks as determined by the Investigator.
4. Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy.
5. Suspected recurrence of prostate cancer (PC) based on rising Prostate-specific antigen (PSA) after definitive therapy on the basis of:

   1. Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per American Urological Association recommendation) or
   2. Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (per American Society for Therapeutic Radiology and Oncology-Phoenix consensus definition).
6. Negative or equivocal findings for PC on conventional imaging performed as part of standard of care workup within 60 days prior to Day 0.
7. The Eastern Cooperative Oncology performance status 0-2.
8. Adequate recovery from acute toxic effects of any prior therapy.
9. Estimated Glomerular Filtration Rate of 30 mL/min or higher.
10. Adequate liver function.
11. For participants who have partners of childbearing potential: Partner and/or participant must use a method of birth control with adequate barrier protection.

Exclusion Criteria:

1. Participants who received other investigational agents within 28 days prior to Day 0.
2. Participants administered any high energy (\>300 kiloelectronvolts (keV)) gamma-emitting radioisotope within 5 physical half-lives prior to Day 0.
3. Ongoing treatment or treatment within 90 days of Day 0 with any systemic therapy (e.g. androgen-deprivation therapy, antiandrogen, gonadotropin-releasing hormone, luteinizing hormone-releasing hormone agonist or antagonist) for PC.
4. Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
5. Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.
Efficacy and Safety of Rimonabant With or Without Hypocaloric Diet in Obese Patients

The primary objective of this study is to assess the effect of rimonabant on the energy intake (kcal/day/meal) from ad-libitum high-fat dinner (primary endpoint), pre- and post-ingestive responses, and the hedonic evaluation of food, and its effect on food choice, cravings and feelings of control.

The secondary objectives are to determine the effect of rimonabant on body weight with or without hypocaloric diet and its clinical and laboratory safety.


Eligibility Criteria:
Inclusion Criteria:

* Obese subjects with Body Mass Index ≥ 30 and \< 45 kg/m²

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Serum LncRNAs as Early Potential Biomarkers for the Prediction of Preeclampsia

To identify lncRNAs differentially expressed at early stages of gestation in the serum of pregnant women, who later developed severe preeclampsia (sPE) in the third trimester of pregnancy compared to women with normal pregnancy .

Preeclampsia (PE) is a pregnancy syndrome characterized by hypertension and proteinuria, and a leading cause of maternal and fetal morbidity and mortality, with poorly defined pathophysiological mechanisms remain. Circulating lncRNAs are long, noncoding RNA molecules, which negatively regulate gene expression, and considered as promising biomarkers for PE. The objective of the study is to evaluate circulating lncRNA signatures in women with PE compared to healthy women, and in women sub-grouped per PE severity. This study assessed lncRNA expression profile in the serum at early stages of gestation of women who later developed severe preeclampsia (sPE) in the third trimester of pregnancy compared to women with uncomplicated pregnancies. Circulating lncRNA was extracted from maternal serum. This study also assess lncRNA expression profile in the placenta tissues of PE patients and healthy pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* new onset hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg on two occasions at least 4 h apart) after 20 weeks of gestation in women who previously had normal blood pressure.
* proteinuria (the excretion of 300 mg or more of protein in a 24-hour urine collection)or other signs/symptoms of preeclampsia after 20 weeks of gestation in women who previously had normal blood pressure.

Exclusion Criteria:

* maternal infections
* smoking
* chemical dependency
* known major foetal or chromosomal anomalies
* intrahepatic cholestasis during pregnancy
* assisted reproductive technology (ART) treatments
* chronic hypertension.
Effectiveness of Toothpaste Containing the Active Ingredient of Galla Chinensis Extract on Treating Dentin Hypersensitivity

This clinical trial was conducted to compare the desensitizing effect of toothpaste containing the active ingredient of an extract of Galla chinensis and toothpaste containing fluoride in patients with dentin hypersensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years.
* Overall good oral hygiene status.
* Participants show tooth neck abrasion or gingival retraction.
* Patients have subjective dentin hypersensitivity (at least 1 tooth) after using airflow.
* No history of periodontal treatment, including periodontal surgery, in the past year.
* Written informed consent

Exclusion Criteria:

* Patient with severe periodontitis or severe erosion damage.
* Patients with a compromised medical history, or had received therapeutic irradiation to the head and neck region.
* Medically compromised patients where pain levels would be compromised.
* If analgesics or antibiotics have been administrated by the patient during the past 12 hours preoperatively as it might alter their pain perception.
* Patients reporting bruxism or clenching in order to avoid further pressure on an already hypersensitive tooth inducing subsequent irritation and inflammation.
* Teeth that show association with acute periapical abscess and swelling.
* Greater than grade I mobility or pocket depth greater than 5mm.
* Non-restorable teeth or hopeless teeth.
* Immature teeth.
* Radiographic evidence of external or internal root resorption.
* Alcoholic and smoker patients.
* Pregnant or breastfeeding ladies.
* Patients having physical disabilities, or who are unable to brush their teeth
* Patients who have a history of allergies to any personal oral care product or ingredient, or who are taking anti-inflammatory drugs within the previous month.
* Individuals who had sensitive teeth but with one of the following conditions will be excluded from the study, teeth with large restorations, abutment of teeth of removable partial dentures, dental caries, enamel cracks, leakage of fillings or other restorations, cracked 23
* teeth, dental pulp lesions, dental abscesses, pulpitis, and atypical facial pain.
* Patients had participated in a clinical trial within 6 months before commencement of this trial.
* Patients unable to return for recall appointment.
Bioequivalency Study of Calcitriol Tablets Under Fasting Conditions

The objective of this study was to assess the bioequivalence of Roxane Laboratories' Calcitriol capsules, 0.25 mcg, to ROCALTROL® capsules, 0.25 mcg (Roche) using a single-dose, 2-treatment, 2-period, crossover design, under fasting conditions


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Calcitriol or any comparable or similar product.
The Effect of Analgesia Methods Applied in Gynecological Cancer Surgeries on Postoperative Analgesia

The aim of this study is to compare the effectiveness of intrathecal morphine and four-quadrant transversus abdominis plane block applied for postoperative analgesia in gynecological cancer surgeries.

The key question(s) it aims to answer are:

\[Is intrathecal morphine more effective in postoperative analgesia?\] Patients who underwent gynecological cancer surgery were examined retrospectively. The investigators evaluated the effect of intrathecal morphine and four-quadrant transversus abdominis plane block applied for postoperative analgesia on pain scores and postoperative opioid use.

Our study was designed retrospectively. The investigators evaluated analgesia methods in patients who underwent laparoscopic or open surgery due to gynecological cancer between June 2023 and December 2023. The investigators evaluated the effect of intrathecal morphine and four-quadrant transversus abdominis plane block on postoperative analgesia and opioid use.

Group 1: Intrathecal morphine administered group Group 2: Four quadrant transversus abdominis plane block applied group

Eligibility Criteria:
Inclusion Criteria:

* 18 years

  * Patients who have undergone gynecological cancer surgery

Exclusion Criteria:

* \<18 years
* Those with missing data
Comparison of Depth of Sedation Performance Between SedLine and Comparator Device During General Anesthesia

The primary objective is to compare the performance of Masimo's SedLine and the comparator's device systems during surgery. Relative accuracy of the individual depth of sedation indices will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years old and older at the time of consent.
* ASA status I, II, or III.
* English-speaking subjects.
* Scheduled for surgical and non-surgical procedures scheduled under general anesthesia (Common procedures include but are not restricted to tonsillectomy, adenoidectomy, urological procedures, dental rehabilitation, orthopedic procedures, biopsies, audiogram, nuclear scans, gastroscopy, colonoscopy, etc.).

Exclusion Criteria:

* Any deformities or devices that may prevent application of EEG Sensor to forehead with a proper fit.
* Subjects who are developmentally delayed.
* Subjects deemed not suitable for study at the discretion of the investigator.