cyrilzakka/clinical-trials huggingface dataset:
Lipoic Acid for Progressive Multiple Sclerosis (MS)

The purpose of the study is to determine if lipoic acid can preserve mobility and protect the brain in progressive forms of multiple sclerosis.

This two-year study will determine if daily oral intake of lipoic acid will prove superior to placebo in reducing injury to the brain and maintaining mobility in progressive MS. Mobility will be assessed with the timed 25-foot walk test and 2-minute timed walk test as well as fall counts. Neuroprotection will be measured by the extent of brain volume loss seen on MRI.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of progressive MS as defined by the study
* Able to give informed consent and to adhere to study procedures.
* Expanded Disability Status Scale (EDSS) 3.0 - 6.5: ambulatory for at least 20 meters without rest and use of bilateral aids (canes, crutches, walker) or better.

Exclusion Criteria:

* A self-reported medical or neurological problem other than MS that is a cause of progressive or fluctuating gait dysfunction
* Unable to undergo MRI
* Unable to follow directions in English as standardized scales are not all validated in other languages.
* Current major disease or disorder other than MS (e.g., cancer, renal disease, end-stage cardiopulmonary disease, post-traumatic stress disorder, etc.) that may interfere with study procedures. Note: Stable abnormal laboratory values of no more than Grade 1 determined to not be of clinical significance to the primary treating physician for that condition may be permitted per local site investigator discretion.
* Pregnant or breast-feeding.
* Insulin-dependent diabetes or diabetes not controlled on oral diabetes medications.
* Scheduled (every 3 months or more frequently) IV or oral steroids in the year prior to enrolment.
* IV or oral steroids in the 60 days prior to enrolment.
* Use of LA in the prior 2 years exceeding the equivalent of 1200mg daily for 3 months.
* Participation in the pilot LA in SPMS trial.
Towards the Validation of a New Blood Biomarker for the Early Diagnosis of Parkinson's Disease

The investigators have recently discovered a metabolic biomarker which predicts Parkinson's disease (PD) at the early stages in patients and in animal models. The aim of BIOPARK is to investigate how the biomarker evolves in advanced PD stage, when diagnosis confirmation is higher, an in de novo PD patients who come from a different geographical area than those of the publication (since it is known that the metabolome is largely influenced by lifestyle). They will also evaluate if the biomarker is able to distinguish patients with a parkinsonian syndrome often confused with parkinson's disease, i.e. Multiple System Atrophy (MSA).

Parkinson's disease (PD) affects more than 7 million people worldwide and represents a growing health and socio-economic burden. It is an incurable neurodegenerative disease, and the search for biomarkers that allow reliable early diagnosis and provide new therapeutic targets is essential to find cures for PD.

In a recently published preclinical and clinical study, the investigators have identified in 2 rat models of PD and a primate model and in 2 human cohorts from biobanks significant deregulations of 6 serum metabolites: acetoacetate, betaine, beta-hydroxybutyrate, creatine, pyruvate and valine. From these 6 metabolites, they built a composite biomarker, which allowed to classify de novo parkinsonian patients against controls (healthy subjects) with an accuracy (defined as the ratio (correctly classified/total) of 82.6%. This study demonstrated for the first time that a common metabolic dysregulation occurs early in either animal models or in PD patients, thus providing an unbiased diagnostic tool as well as major hypothesis for the understanding of the pathophysiology of the disease and the development of innovative therapeutic approaches.

The goal of BIOPARK is to improve the clinical diagnosis of early PD using the blood biomarker.

To this end, the investigators will study whether the biomarker is able to differentiate between patients with PD \>5 years and already treated with dopaminergic drugs (thus with a very high diagnostic confirmation) and patients suffering from other neurodegenerative diseases often confused with it, mainly Multiple Systeme Atrophy (MSA). Furthermore, the investigators hope to confirm the preliminary results on a new cohort of de novo patients.

For that aim, they will use the already optimized method for biomarker discovery, i.e. Nuclear Magnetic Resonance (NMR)-based metabolomics on patient serum.

Eligibility Criteria:
Inclusion Criteria:

* Patients with de novo Parkinson's disease, without dopaminergic treatment
* Patients with advanced Parkinson's disease (\> 5years) with dopaminergic treatment
* Patients with multiple system atrophy

Exclusion Criteria:

* Patients with deep brain stimulation
* Other neurodegenerative diseases
* patients protected by french law (pregnant or lactating women, prisoners, ...)
Minimal Residual Disease-guided Adjuvant Therapy for Gastric Cancer

This is a multicenter, single-arm, interventional study to explore the feasibility of circulating tumor DNA (ctDNA)-MRD testing to guide postoperative adjuvant treatment strategies in patients with stage II-III gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who have undergone D2 gastrectomy, achieved R0 resection, and are pathologically diagnosed with stage II-III gastric cancer.
2. No preoperative neoadjuvant or adjuvant therapy received.
3. Voluntary participation with signed informed consent, demonstrating good compliance and willingness to cooperate with follow-up procedures.
4. Age between 18-75 years, with no gender restrictions.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
6. Estimated survival of 6 months or more.
7. Baseline hematological and biochemical parameters within specified limits: a. Hemoglobin ≥ 80g/L. b. Absolute neutrophil count ≥ 1.5×10\^9/L. c. Platelet count ≥ 100×10\^9/L. d. Aspartate or alanine aminotransferase ≤ 2.5 times the upper limit of normal. e. Alkaline phosphatase ≤ 2.5 times the upper limit of normal. f. Thyroid-stimulating hormone (TSH) ≤ 1 times the upper limit of normal (if abnormal, T3 and T4 levels must be normal).

Exclusion Criteria:

1. Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test at baseline.
2. Evidence of postoperative recurrence or metastasis.
3. Previous anti-tumor therapy, including chemotherapy, radiotherapy, or immunotherapy.
4. Positive resection margins identified in postoperative pathology.
5. History of other malignancies within the past five years, except certain skin cancers, superficial bladder cancer, in situ cervical or breast cancer.
6. Uncontrolled pleural effusion, pericardial effusion, or ascites.
7. Severe cardiovascular conditions such as symptomatic coronary artery disease, congestive heart failure (grade ≥ II), uncontrolled arrhythmias, or myocardial infarction within the last 12 months.
8. Uncontrolled infection, severe kidney disease, or other significant concurrent diseases.
9. Allergic reactions to study drugs.
10. Receipt of any anti-tumor therapy within 4 weeks prior to enrollment.
11. Administration of live attenuated vaccines within 4 weeks prior to the first study treatment dose or plans to receive such vaccines during the study period.
12. Positive HIV antibody, active hepatitis B or C (with specific viral load criteria).
13. Positive for COVID-19 nucleic acid or antigen test.
14. Other conditions deemed by the investigator to potentially affect patient safety or trial compliance, including serious illnesses requiring treatment, severe laboratory abnormalities, or other social or family reasons.
Randomized Prospective Study of Selective Laser Trabeculoplasty (SLT) Versus Argon Trabeculoplasty (ALT) in Patients With Pseudoexfoliation Glaucoma and Ocular Hypertension

Multi-center, prospective, randomized, controlled clinical trial to compare selective laser trabeculoplasty (SLT) and Argon laser trabeculoplasty (ALT) in pseudoexfoliation glaucoma and ocular hypertension patients. IOP will be recorded, at baseline, 6 weeks, 6 months and 1 year after the laser procedure.

This study derives from a clinical observation that laser treated eyed with PXF glaucoma may have a similar long-term response rates when either ALT or SLT is performed. Some authors have considered that there is a risk of IOP elevation in the immediate post laser period with ALT or SLT as a complication to be related to denser angle pigmentation (20,48). (46) No long-term analysis comparing response rates of both laser treatments in these types of patients has been done.

Primary objective is to determine which laser therapy has more IOP lowering effect as primary or adjunctive treatment in eyes diagnosed with ocular hypertension and glaucoma associated to PXF. Response rates will be compared between groups at long-term.

Secondary objective is to determine the relationship between the type of laser therapy performed and angle pigmentation, number of applications, and amount of energy used with age, number and type of medication used post laser and phakic status.

Eligibility Criteria:
Inclusion Criteria:

* Only patients with clinical evidence of unilateral or bilateral open angle pseudoexfoliation ocular hypertension (IOP \> 22mmHg) or glaucoma (Evidence on Humphrey 30-2 or Goldmann of nerve fiber layer damage) with uncontrolled IOP, over 18 years of age, and are willing to participate in the study will be included. If increased IOP is bilateral then the worst eye will be treated.

Exclusion Criteria:

* Patients will be excluded if they have evidence of any glaucoma other than pseudoexfoliative open angle, if the trabecular meshwork cannot be seen in 360 degrees, if they had previous laser therapy ALT or SLT, if they have advanced visual field defect (split fixation or a scotoma within 10 degrees fixation), taking any systemic or topical steroids, have had any previous ocular surgery (glaucoma or cataract extraction included) or laser within the previous six months, if they are monocular patients, if they have any corneal disease precluding the angle evaluation and treatment, or if they had ocular trauma.
Differential Risks for Melanoma: p16 and DNA Repair

The goal of this study is to find out if some people are more likely to get melanoma, a form of skin cancer, than others. People respond to the environment in different ways. Some may be born with genes that make them more likely to get this type of skin cancer. Genes are made up of DNA. DNA damage is one of the first steps in developing cancer. Each person has many ways to repair normal damage to their genes. Some people may have a lower level of this repair and that may make them more likely to get cancer. Some genes are important for DNA repair. The genes we want to test are thought to affect the rate at which DNA can be repaired. We also want to find out if sun habits are related to these levels of DNA repair or genetic mutations.


Eligibility Criteria:
Inclusion Criteria:

* Cases will be patients 18 years or older with a histologically confirmed, second or multiple primary melanoma. These will be sequentially selected from subjects seen at Memorial Sloan-Kettering Cancer Center or the Yale University Pigmented Lesion Clinic.
* Controls will be patients 18 years or older with a histologically confirmed first primary melanoma diagnosed no earlier than 12 months prior to the study start date. One control will be selected per case. These patients will be referred to the study by the Melanoma Disease Management Team at Memorial Sloan-Kettering Cancer Center. Controls will be frequency-matched to cases on the basis of sex and age (within 10 year age groups).
* Healthy controls will be subjects 18 years or older recruited from the general population through random digit dialing. These subjects will have no history of melanoma. They will also be frequency matched to cases on the basis of sex and 10-year age group.
* The subject must have a histologically confirmed malignant melanoma.
* Cases may have an in situ melanoma as the second primary.
* Melanoma Controls may have only one primary melanoma.
* Healthy controls should have no history of melanoma.
* The subject's physician consents to his/her patient's participation in the study (if the subject has a diagnosis of melanoma).
* The subject has consented, in writing, to participate in the study

Exclusion Criteria:

* Karnofsky status less than 60 (see Appendix). This will be evaluated by the physician treating the subject for melanoma at the time permission is given for participation
* Patient had chemotherapy or radiation therapy within the last 6 weeks.
Long-term Outcome Evaluation of Patients Undergoing Autologous Chondrocyte Transplantation Delivered on Biomaterial

Chondro-Long study is prospective observational study for a long-term clinical evaluation (follow-up up to 25 years) in patients treated with autologous chondrocyte transplantation delivered on biomaterial for full-thickness chondral defects (Outerbridge grade III - IV) at the level of femoral condyles, trochlea, patella and tibial plateau.

The aim of the study is to collect long-term clinical data from the case series of patients surgically treated from 1999 to 2006 with autologous chondrocyte transplantation delivered on biomaterial for full-thickness chondral defects (Outerbridge grade III - IV) or osteochondral defects at the level of femoral condyles, trochlea, patella, and tibial plateau. The objective of the study is to demonstrate the efficacy of this long-term cartilage regeneration technique (follow-up up to 25 years) in improving patient symptomatology and functional capacity

Patients will be recruited from all subjects surgically treated with autologous chondrocyte transplantation delivered on biomaterial for chondral/osteochondral lesions at the femoral condyles, trochlea, patella, and tibial plateau from 1999 to 2006 at the Rizzoli Orthopaedic Institute. The study has 3 phases: Identification of includable patients, Follow-up assessment byTelemedicine platform, and the collection of study-specific clinical data of enrolled patients.

Clinical score data will be collected from the medical records and questionnaires conducted in the mid-term of patients enrolled in the study. These data will be used, together with data collected by telemedicine/long-term e-mail questionnaire, to evaluate the time course of outcomes after surgical treatment with autologous chondrocyte transplantation delivered on biomaterial

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent autologous chondrocyte transplantation surgery delivered on biomaterial (Hyalograft C) from 1999 to 2006 at the Rizzoli Orthopaedic Institute who met the following criteria at the time of surgery:
* Full-thickness chondral defects (Outerbridge grade III - IV) and osteochondral defects at the femoral condyles, trochlea, patella and tibial plateau.
* Patients aged between 14 and 60 years at the time of surgery.
* Male and female sex.

Exclusion Criteria:

* Patients no longer available
Cisplatin and Radiation Therapy in Treating Patients With Stage IV Cancer of the Head and Neck

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of cisplatin and radiation therapy in treating patients with stage IV cancer of the head and neck.

OBJECTIVES: I. Determine the percentage of patients for whom a complete course of therapy can be administered using targeted supradose cisplatin chemoradiation in patients with squamous cell carcinoma of the head and neck. II. Determine the partial and complete response rate of cisplatin chemoradiation. III. Determine the incidence of adverse events using cisplatin chemoradiation therapy. IV. Determine the rate of disease-free survival and overall survival in these patients. V. Determine the incidence and pattern of recurrence in these patients. VI. Document quality of life measured by disease-specific instruments in these patients.

OUTLINE: All patients receive four courses of cisplatin on days 1, 8, 15, and 22 concurrent with radiotherapy. One course of chemotherapy consists of intra-arterial cisplatin given over 3-5 minutes. Radiotherapy is given 5 days a week for 7 weeks. This weekly cisplatin chemoradiation course will be repeated 4 times, providing recovery from toxicity is present. Dexamethasone is started the evening prior to cisplatin treatment, and continues until the morning following the procedure.

PROJECTED ACCRUAL: 60 patients will be enrolled.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx No distant metastatic disease No previous or concurrent head and neck primaries No lip, nasopharynx, or salivary gland lesions No recurrent tumors Stage IV disease comprised of T4 NO-3 lesions

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky greater than 60 Life Expectancy: Not specified Hematopoietic: ANC greater than 2,000 Platelet count greater than 100,000 Hepatic: Not specified Renal: Creatinine clearance greater than 50 mL/min Cardiovascular: Not specified Other: Not pregnant or nursing No adverse medical illnesses No imaging studies performed greater than one month preregistration No laboratory studies greater than 2 weeks preregistration No other malignancies, except for basal or squamous cell of the skin, within the past 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the head and neck Surgery: No prior surgery to study site other than a biopsy Other: Protocol treatment must begin within 8 weeks of biopsy
The Effect of Visual Video With Korotkoff Sounds on Blood Pressure Measurement Skills and Anxiety Levels

Background: The aim of this study was to determine the effect of visual video with korotkoff sounds on nursing students' blood presssure measurement skills and anxiety levels.

Methods: This was a randomized controlled experimental study conducted at the nursing department of the faculty of health sciences of a university. Intervention participants were shown and listened visual video with korotkoff sounds before blood presssure measurement. Aural and visual video containing Korotkoff sounds were shown to the students before the practice.

Background: The aim of this study was to determine the effect of visual video with korotkoff sounds on nursing students' blood presssure measurement skills and anxiety levels.

Methods: This was a randomized controlled experimental study conducted at the nursing department of the faculty of health sciences of a university. Intervention participants were shown and listened visual video with korotkoff sounds before blood presssure measurement. Aural and visual video containing Korotkoff sounds were shown to the students before the practice. The data of the research were collected with the State-Trait Anxiety Inventory short version (STAIS-5, STAIT-5) and the Student introduction form.

Eligibility Criteria:
Inclusion Criteria:

* Studying in the first year of the nursing department in the 2021-2022 academic year,
* Taking the "pulse and blood pressure measurement" course and laboratory practice
* Students who agree to participate in the study will be included.

Exclusion Criteria:

* Previous manual blood pressure measurement experience,
* Those who do not participate in the theoretical part of the "pulse and blood pressure measurement" course,
* Students who do not attend the lesson on the day of the applications will not be included.
A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia

The use of low-dose CBP dosed nightly at bedtime for FM was supported by the results of Tonix' TNX-CY-F202 Phase 2b study (also referred to as the BESTFIT Study). The TNX-CY-F202 study provided evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.

The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Primary Fibromyalgia (2010 ACR criteria)
* Male or female 18-75 years old
* For patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressant therapy
* Willing and able to withdraw specific therapies (ask PI)
* Medically acceptable form of contraception (female only)
* Signed informed consent

Exclusion Criteria:

* Arthritis, lupus and other systemic auto-immune diseases
* Regional or persistent pain that could interfere with assessment of fibromyalgia pain
* Bipolar and psychotic disorders
* Increased risk of suicide
* Significant clinical (cardiac, systemic infection, systemic corticosteroid requirement, drug/alcohol abuse) or laboratory abnormalities.
* Inability to wash-out specific medications (ask PI)
* Known hypersensitivity to cyclobenzaprine
* Others: seizure disorders, severe/untreated sleep apnea, BMI\>40
Evaluate the Efficacy and Safety of Lomitapide in Pediatric Patients With Homozygous Familial Hypercholesterolemia on Stable Lipid-lowering Therapy

This is a Phase 3 single-arm, open-label, international, multi-center clinical trial to evaluate the efficacy and safety of lomitapide in pediatric patients with HoFH who are receiving stable lipid-lowering therapy, including LDL apheresis. The study is comprised of a 12-week Run-in Period, a primary 24-week Efficacy Phase, followed by an 80-week Safety Phase.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged ≥5 and \<18 years with diagnosed functional HoFH
2. Patient must weigh at least 15 kg and be at or above the 10th percentile in BMI and at least 10th percentile in height for age and gender based on CDC growth charts
3. Negative pregnancy test at Screening and during the study for females of child bearing age
4. Potentially sexually active female patients who are of child-bearing age must either be sexually abstinent or follow two acceptable methods of contraception

Exclusion Criteria:

1. Other forms of primary hyperlipoproteinemia and secondary causes of hypercholesterolemia (e.g., nephrotic syndrome, hypothyroidism).
2. Abnormal liver function test at Screening
3. Moderate or severe hepatic impairment or active liver disease
4. Serum creatine phosphokinase (CPK) level \>2 × ULN.
5. Chronic renal insufficiency
6. History of drug abuse within the last 3 years or habitual alcohol consumption
7. New York Heart Association (NYHA) Class III or IV congestive heart failure.
8. Uncontrolled hypertension
9. In the judgment of the PI, precocious or delayed puberty or endocrine disorder that would affect growth
10. History of non-skin malignancy or other cancers occurring within the past 3 years
11. History of inflammatory bowel disease or other malabsorption syndrome or a history of bowel resection, gastric bypass, or other weight loss surgical procedure.
12. Use of mipomersen within 6 months of Screening.
13. Any medical condition for which the life expectancy is predicted to be less than 5 years.
14. Any patient who is unable to avoid treatment with strong or moderate cytochrome P450 3A4 (CYP3A4) inhibitors, or other drugs contraindicated for use with lomitapide during the study.
15. Participation in an interventional clinical study within 6 weeks for a statin therapy or within 6 months for any other unapproved therapy.