cyrilzakka/clinical-trials huggingface dataset:
Orbit Study: A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Intrathecally Administered ION356 in Participants With Pelizaeus Merzbacher Disease (PMD)

The primary purpose of this study is to evaluate the safety and tolerability of ION356.

This is a Phase 1b, open-label multiple-ascending dose (MAD) study of ION356 in approximately 24 pediatric participants with Pelizaeus-Merzbacher Disease and genetic confirmation of proteolipid protein 1 (PLP1) gene duplication. The study will have 2 parts: a 48-week multiple-ascending dose (MAD) part followed by a long-term extension (LTE) part of 109 weeks. Eligible participants will receive doses of ION356 during the MAD portion of the study and upon completion will seamlessly transition to the open-label LTE to receive doses of ION356.

Eligibility Criteria:
Key Inclusion Criteria

1. Participant's parent or legally accepted representative can provide informed consent, attend all scheduled study visits, provide feedback regarding the participant's symptoms, and can comply with all study requirements.
2. Diagnosis of PMD with genetic confirmation of PLP1 gene duplication.
3. Clinical phenotype and brain imaging consistent with a diagnosis of PMD.
4. Male between the ages of 2 and 17 years, inclusive, at the time of informed consent.
5. Able and willing to meet all study requirements (in the opinion of the Investigator), including travel to Study Center, procedures, measurements, and visits.

Exclusion Criteria

1. Clinically significant abnormalities in medical history, laboratory tests or physical examination.
2. Unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the Investigator.
3. Any contraindication or unwillingness to undergo magnetic resonance imaging (MRI).
4. Treatment with another investigational drug, biological agent, or device within 1 month of Screening, or 5 half-lives of the investigational agent, whichever is longer.
5. Previous treatment with an oligonucleotide (including small interfering ribonucleic acid) within 4 months of Screening if a single dose was received, or within 12 months of Screening if multiple doses were received. This exclusion does not apply to vaccines (both messenger ribonucleic acid \[mRNA\] and viral vector vaccines).
6. History of gene therapy or cell transplantation, or any experimental brain surgery.
7. Current obstructive hydrocephalus.
8. Known brain or spinal disease or previous spinal surgery that would interfere with the lumbar puncture (LP) process, CSF circulation, or safety assessment.
9. Hospitalization for any major medical or surgical procedure involving general anesthesia within 12 weeks prior to Screening or planned during the study.
10. Have any other conditions, which, in the opinion of the Investigator, would make the participant unsuitable for inclusion, or could interfere with the participant participating in or completing the study.
Alcohol and Immune Response

This study investigates how alcohol affects the immune system and behavior in healthy adults. The study also will examine how an individual's typical drinking habits may affect the immune system's response to alcohol.


Eligibility Criteria:
Inclusion Criteria:

* Ages 21-55 years
* Able to speak and read English
* Regular use of alcohol
* Weight \> or = to 110 lbs and body mass index (BMI) in the 18.5-30 kg/m2 range
* No self-reported use of drugs

Exclusion Criteria:

* Currently seeking treatment for alcohol or drug use
* Chronic disease
* Use of certain medications
* GI disorders
* Daily/near-daily use of NSAIDs
* Positive urine test for certain drugs
* History of withdrawal symptoms precipitated by alcohol abstinence
* Clinical Institute Withdrawal Assessment for Alcohol score greater than or equal to 10
* History of seizures
* Current major psychiatric disorder
* History of adverse reaction to standard blood draw
* Inability to abstain from tobacco for 8 hours
* Inability to abstain from cannabis for 48 hours
* Pregnant, breastfeeding, or may become pregnant
Effects Of Moderate Physical Activity On Hb, Physical Fitness And Psychological Well Being In Females

The study is design To determine the effectiveness of moderate physical activity on Hb, Physical fitness and psychological well-being in females.

The majority of literature showed that level of physical activity is associated with Hb level. But there is paucity in the literature regarding the cause and effect relationship of PA and Hb. Literature shows lacking that there is any defined physical activity, which can affect the Hb concentration. According to literature, different studies conduct at Hb level in individuals with different diseases i.e. rheumatic arthritis, Diabetes mellitus etc. The aim of my study is to determining the cause and effect relationship of moderate physical activity on Hb level in healthy female population, one of the easiest moderate physical activity is brisk walk. Brisk walk is an aerobic exercise. People do get best physiological results of aerobic exercise with intensity of exercise 60-70% of the maximum pulse with longer time duration as well as increase frequency of exercise, which increase no of hemoglobin level due to this need more oxygen to performing physical activity in return basal metabolic rate increases and achieve physical fitness and gain relieve from the psychological problems.

Eligibility Criteria:
Inclusion Criteria:

1. Female 2.18-25 years 3. Hb\<12

Exclusion Criteria:

1. Lower limb musculoskeletal injury
2. Any head Injury or trauma in past 6 months.
3. Any neurological or musculoskeletal condition
4. Acute or chronic infections diseases
Prospective and Retrospective Observational Evaluation of Real World Outcome of Unfit AML Patients Treated With the Combination Venetoclax Plus Hypomethylating Agents, Under the Italian Law No.648/96

This is an retrospective and prospective observational multinstitutional study to evaluate the impact on outcome of the combination of HMA plus venetoclax in AML patients unfit for intensive chemotherapy in a "real-life" scenario. No additional procedures or visits other than those required by normal clinical practice will be required. Patients will be observed for at least 24 months.

This is an retrospective and prospective observational multinstitutional study to evaluate the impact on outcome of the combination of HMA plus venetoclax in patients with AML unfit for intensive chemotherapy in a "real-life" scenario. At least 104 AML adult patients ineligible for intensive chemotherapy treated with the combination HMA plus venetoclax under the Italian Law No.648/96 by December 2021 will be enrolled. No additional procedures or visits other than those required by normal clinical practice will be required. Patients will be observed for at least 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years with a diagnosis of previously untreated primary or secondary AML;
* Deemed ineligible for intensive chemotherapy because of age (≥75 years), performance status or comorbidities as defined by the treating physicians, according to SIE/SIES/GITMO criteria;
* Eligible to receive the combination HMA plus venetoclax under the Italian Law No.648/96 by December 2021;
* Signed written informed consent according to ICH/EU/GCP and national local laws.

Exclusion Criteria:

* Acute promyelocytic Leukemia;
* Previous first-line treatments for AML;
* Previous treatments with HMA.
Brazilian Registry for Clinical Presentation of Individuals With COVID-19 (SARS-Brazil)

This is a registry-based cohort study of all adult patients (≥18 years) with confirmed or suspected SARS-CoV-2 infection.

The main goal is to describe mortality incidence, demographic characteristics, coexisting conditions, treatments, outcomes among SARS-CoV2 infected patients.

A secondary goal is to identify biological factors (OMICS - genomic, proteomic and metabolomics characterization) associated with severity conditions for these patients.

Registry on characteristics and outcomes of hospitalized and non-hospitalized SARS-CoV2 infected patients in Brazil.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years);
* Confirmed or suspected SARS-CoV2 infection

Exclusion Criteria:

* Patient who expressed opposition to participation in the study
ELB245 for 12 Weeks Versus 4mg Tolterodine in Patients With Incontinent Overactive Bladder (OAB)

This study is designed to determine the efficacy of escalating doses of ELB245 versus placebo , when administered to patients with OAB and to compare the efficacy of escalating doses of ELB245 versus the standard treatment tolterodine, when administered to patients with OAB.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients at least 18 years of age
* Symptoms of OAB for a minimum of 3 consecutive months prior to study entry; severity of OAB (as defined by patient reported symptoms) for a minimum of one month prior to study entry
* Ability to use a toilet independently and without difficulty
* No treatment with any medication against OAB during the 4 weeks prior to study entry
* Written informed consent

Exclusion Criteria:

* Breastfeeding women, pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and not practicing a highly reliable method of birth control
* Any local pathology, that might cause the bladder symptoms
* Significant stress urinary incontinence or mixed stress/urgency incontinence
* Any neurological disease affecting bladder function or muscle strength
* Patient history of any lower urinary tract surgery or previous pelvic irradiation
* Local administration of botulinum toxin within the last 9 months in the lower urinary tract
* Start or change of a behavioral bladder training program
* Post voiding residual volumes larger than 250ml or symptoms of clinically relevant bladder outlet obstruction
* Nocturial polyuria
* History of liver disease and/or impaired liver function
* Cholestasis
* Chronic alcohol or drug abuse
* Evidence of significantly impaired renal function (
* Diabetes mellitus (type I or II) with significant peripheral neuropathy and/or polyuria
* Inflammatory bowel disease such as Crohn's disease, or ulcerative colitis
* Uncontrolled narrow angle glaucoma
* Chronic use of carbamazepine or paracetamol
* Participation in any drug study in the preceding 3 months
* Concomitant treatment with strong CYP3A4 inhibitors
* History or evidence of relevant cardiovascular or cerebrovascular disorders
Postoperative Adjuvant Therapy for Stage II-III Gastric Cancer

For patients with stage II-III gastric cancer after radical D2 resection and R0 resection, postoperative adjuvant therapy guided by ctDNA-MRD (MRD-GATE external cohort) was not inferior to the standard chemotherapy regimen (this cohort).


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.
Dynepo Infrequent Dosing Study

The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as measured by haemoglobin at week 24 and secondly to demonstrate the non-inferiority of efficacy between once weekly and once every two weeks dose schedules of Dynepo in patients previously stable on EPO, as measured by Hb over Weeks 16 to 24.


Eligibility Criteria:
Inclusion Criteria:

* Aged at least 18 years with chronic kidney disease (Kidney Disease Outcomes Quality Initiative \[KDOQI\] stage III-V).
* Stable on and taking doses \<= 10,000 IU/week of subcutaneous (sc) EPO or requiring initiation of EPO.
* Transferrin saturation \>= 20% and ferritin \>= 100 ng/mL.

Exclusion Criteria:

* Uncontrolled hypertension.
* Requiring doses of EPO \> 10,000 IU/week.
* Two or more doses of prescribed EPO treatment missed ot withheld by physician order in the 14 days immediately prior tp randomisation in the study.
* Active bleeding disorder (diathesis) (for example, Gastrointestinal or Genitourinary tract bleeding).
* Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to randomisation in the study.
* Androgen therapy in the 30 days immediately prior to randomisation in the study.
* Known Human Immunodeficiency Virus(HIV)infection.
* History of hypersensitivity to EPO therapy or to any of the excipients of Dynepo.
Interplay Between Oxytocin and Cortisol During Stress in Borderline Personality Disorder

This study aims to determine the feasibility and preliminary data on the interaction between oxytocin and cortisol during stress in borderline personnality disorder.

The investigators will recruit 50 female patients with borderline personnality disorder and 50 controls with no psychiatric diagnosis, aged between 18 and 25 years old.

salivary cortisol daily curve ( 6 measures during the day) will be measured in participant's naturalistic environnement, together with salivary oxytocin. In addition, salivary oxytocin and cortisol will be measured during a psychosocial stress task and recovery.

Eligibility Criteria:
Inclusion Criteria:

* Borderline personality disorder-DSM V

Exclusion Criteria:

* Schizophrenia
Effectiveness of the Defocus Incorporated Spectacle Lenses on Fast Progressing Myope - Auxiliary Group

The purpose of this study is to examine the efficacy and performance of the Defocus Incorporated Multiple Segments (DIMS) Spectacle lenses on controlling myopia progression in fast progressing myopic children.

DIMS spectacle lens is a multifocal spectacle lens that produces myopic defocus images and corrects distance refractive errors at the same time.

Participants will be prescribed a pair of DIMS spectacle lenses. Their cycloplegic refraction and axial length will be monitored every 6 months over 2 years.

Eligibility Criteria:
Inclusion Criteria:

* SER: -1.00D or below
* Documented history of fast progressing myopia, either in SER or AL
* SER progression: 0.50D/year or more
* AL elongation: 0.27mm/year or more
* Best-corrected monocular visual acuity (VA) in both eyes: 0.00 logMAR (equivalent) or better
* Acceptance of random group allocation and the masked study design
* Anisometropia of 1.50 D or less
* Astigmatism of 2.00 D or less

Exclusion Criteria:

* Strabismus and binocular vision abnormalities
* Ocular and systemic abnormalities
* Prior experience of myopia control
Meniscus Repair With Simultaneous ACL Reconstruction: Clinical Outcomes，Failure Rates And Subsequent Processing

Our study has explored the causes of failure of meniscus repair and investigated the clinical effects of partial meniscectomy when meniscus repair failed.

Background: Meniscus repair performed during ACL reconstruction may fail and the subsequent treatment includes revision meniscal repair or partial meniscectomy.

Purpose: To retrospectively analyze the clinical outcomes of meniscus repair with simultaneous anterior cruciate ligament (ACL) reconstruction and explore the causes of failure of meniscus repair.

Methods: From May 2013 to July 2018, the clinical data of 165 patients who were treated with meniscus surgery and simultaneous ACL reconstruction by the same doctor, including 69 cases of meniscus repair (repair group) and 96 cases of partial meniscectomy (partial meniscectomy group), were retrospectively analyzed. The 69 patients of the repair group were divided into the nonfailure group (62 cases) and the failure group (7 cases) depending on the repair effect. The average follow-up period was 38 (±10.5) months. Postoperative outcomes of the repair group and the partial meniscectomy group were compared. General conditions and postoperative outcomes of the failure group and the nonfailure group were compared. Seven patients in the failure group who underwent second arthroscopy were followed up for 30 (±17.4) months, and their postoperative outcomes were summarized.

Eligibility Criteria:
Inclusion Criteria:

1. patients with intraoperatively confirmed ACL rupture combined with medial, lateral, or medial and lateral meniscal injury;
2. age \<60 years
3. no history of previous ipsilateral knee meniscal injury.

Exclusion Criteria:

1. ACL rupture associated with fracture, collateral ligament injury, or complex ligament injury;
2. a history of knee surgery;
3. a significant degree of osteoarthritis.
Integrated Smoking Cessation Treatment for Low Income Community Corrections

This study recruited cigarette smokers under supervision in community corrections (e.g., probation, parole, drug courts, etc.) in the Birmingham, Alabama area. Smokers received 12 weeks of bupropion treatment and brief physician advice to quit smoking or 12 weeks of bupropion treatment and 4 sessions of intensive counseling around smoking cessation. The study was stratified on race such that equal proportions of African Americans and Caucasians were enrolled in the two study groups. It was hypothesized that smokers receiving intensive counseling will have higher quit rates compared to smokers receiving brief advice to quit.


Eligibility Criteria:
Inclusion Criteria:

* At least 19 years or older
* Enrolled in criminal justice community supervision (e.g., probation, parole, drug court, community corrections, etc)
* Smoking at least 5 cpd for the past year
* Maintained in an unrestricted environment (e.g., not currently in a correctional facility or treatment facility) living in the Birmingham Area and surrounding communities

Exclusion Criteria:

* Pregnant or nursing (all women in this study will be required to use an acceptable form of contraception throughout the administration of the medication)
* Known sensitivity to Zyban or Wellbutrin
* History of seizures
* Current or prior anorexia or bulimia
* Abrupt withdrawal from alcohol or benzodiazepines
* Moderate to severe kidney problems
* Moderate liver problems
* Cognitive impairment such that they cannot provide informed consent
Gut Recovery In Patients Following Surgery

The purpose of the study is to determine if the myoelectrical measurements made by the G-Tech Wireless Patch System correlate with clinical markers of postoperative recovery such as passage of flatus/bowel movement, oral tolerance of diet and discharge readiness. Subsequently the data will be studied to establish which information in the signals is important in determining when to feed patients and possibly discharge them..

Measure myoelectric signals with the G-Tech WPS and determine if a correlation exists between signal strength and the rate of gastrointestinal recovery following surgery. Determine the relationship between gastrointestinal myoelectrical signal strength and clinical markers of recovery such as passage of flatus/bowel movement, oral tolerance of diet and discharge readiness.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to follow all study requirements
* Eighteen (18) years of age or older
* Subject is willing and able to follow all study requirements
* Subject will undergo a colectomy

Exclusion Criteria:

* Subject is pregnant or suspects pregnancy
* Known allergy to medical grade adhesive
The Role of Complement Factor H Polymorphism in the Regulation of Choroidal Vascular Tone in Young Healthy Subjects

Age related macular degeneration (AMD) is a multifactorial disease with a strong genetic component. Given that it is known that impaired regulation of choroidal vascular tone is present in patients with AMD, the current study seeks to investigate whether genetic polymorphisms in risk alleles for AMD are associated with altered choroidal blood flow regulation in healthy subjects. For this purpose a total of 220 healthy volunteers will be included. Choroidal blood flow regulation will be evaluated by measuring choroidal blood flow during isometric exercise. In addition, flicker induced vasodilatation will be studied and retinal vessel calibers will assessed, as well as retinal thickness and macular pigment optical density.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 45 years, nonsmokers
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Systolic blood pressure \< 160 mmHg, diastolic blood pressure \< 90 mmHg
* Normal ophthalmic findings, ametropia less than 3 diopters

Exclusion Criteria:

* Regular use of medication
* Abuse of alcoholic beverages
* Participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug (except hormonal contraceptives)
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks
* History or family history of epilepsy
* Pregnancy, planned pregnancy or lactating
Phase 3 Study of MAP0004 in Adult Migraineurs

This is a randomized, double blind, placebo controlled, parallel group study of MAP0004 in adult migraineurs. Subjects will self administer study drug in the outpatient setting.


Eligibility Criteria:
Major Inclusion Criteria:

* Male or female between 18 and 65 years of age.
* History of episodic, acute migraine (with or without aura) with onset prior to 50

Major Exclusion Criteria:

* Known allergy or sensitivity or contraindication to study drugs or their formulations
* History of chronic pulmonary disease, coronary artery disease (CAD), liver disease, kidney disease, seizures, stroke, or major psychiatric condition.
* Any condition that, in the opinion of the Investigator, would make the subject unsuitable for study participation