cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study to Evaluate the Long-Term Safety Sodium Oligomannate Capsules (GV-971)

A clinical study to evaluate the long-term safety of Sodium Oligomannate Capsules (GV-971)

Sodium oligomannate (Code: GV-971), a marine-derived oligosaccharide after extraction, separation and degradation from algae, can play a role in the treatment of Alzheimer's disease by reconditioning the dysbiosis of gut microbiota, preventing peripheral immune cells from invading the brain, inhibiting the inflammatory response in the brain, and targeting protein folding errors in the brain tissue. Phase I clinical study shows GV-971 was safe and tolerated in healthy adult volunteers when administered continuously at 1200 mg/dose or 1500 mg/day (750 mg/dose, bid) for 5 days. Phase II and III clinical studies show that the treatment of GV-971 at 900 mg/day dosage for 36 weeks can significantly improve the cognitive function of patients with mild to moderate Alzheimer's disease (AD) and was safe and well-tolerated.

Sodium Oligomannate Capsules obtained approval from China's National Medical Products Administration (NMPA) on November 2, 2019, with approval letter number of 2019S00571. This product is a chemical drug with a registration classification of 1.2. It is approved for the clinical indication of mild to moderate Alzheimer's disease and the function of improving the cognitive function of patients. The clinical dosage and administration is 3 capsules (450 mg)/time, bid, po.

Due to the limited number of subjects and observation period of medication in completed GV-971 clinical studies, and the screening of patients with the strict inclusion and exclusion criteria, the adverse reactions and long-term safety of GV-971 cannot be comprehensively observed and recorded. Therefore, according to the requirements of the NMPA for the marketing of new drugs, this study is intended to further carry out a post-marketing investigation on expanded population using a design of a 96-week intensive monitoring clinical trial to determine the incidence of known adverse reactions of GV-971 under long-term administration, observe the occurrence of new adverse reactions, analyze the correlation, incidence, severity, and risk factors of adverse reactions/events, and better guide the rational use of drugs in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Subjects eligible for this study must meet all of the following criteria:

  1. ≥18 years of age;
  2. Signed informed consent form;
  3. Patients receiving GV-971 treatment prescribed by clinicians;

Exclusion Criteria:

* A subject may be excluded from participation in the study if any of the following apply:

  1. Patients who may be allergic to Sodium Oligomannate Capsules as judged by the investigator;
  2. Female participants who are pregnant or lactating;
  3. Patients who cannot cooperate to complete the follow-up inquiries;
  4. Any other diseases or conditions that are inappropriate to participate in this clinical trial in the opinion of the investigator.
Validity and Reproducibility of Dietary Assessment Against Objective Measures

A cross-sectional study with repeated measurements among healthy Danish adults to assess the validity and reproducibility of a self-administered 7-day web-based dietary assessment tool, myfood24® tested against objective biomarkers.

Healthy volunteers (age 35-70 yrs; BMI 22-32) will be recruited for the study. Informed consent will be obtained and participants will complete a self-administered web-based 7-day 24-hour dietary recall tool (myfood24®).Validity of this dietary registration tool will be assessed by comparing the estimated intake of selected nutrients (protein, energy) and selected food groups (fruit and vegetables, whole grain, coffee, alcoholic beverages) against objective biomarkers obtained from a 24-hour urine sample, through a measurement of resting energy metabolic rate, and from a fasting blood sample, respectively. Reproducibility will be assessed by comparison of the results from two self-administered web-based 7-day 24-hour dietary recalls obtained 4 weeks (± 1 weeks) apart.

Eligibility Criteria:
Inclusion criteria:

* Apparently healthy adults between 35 and 70 years old
* Body mass index (BMI) between 22-32 kg/m2
* Weight stable defined as gain or loss of \< 2.5% body weight during the past 3 months;
* Willingness to maintain current dietary and physical activity habits throughout the study period.
* Have high-speed internet access;
* Able to speak, read and write Danish;
* Willing to visit the Department of Nutrition, Exercise, and Sports (NEXS).

Exclusion Criteria:

* Clinically diagnosed chronic disease,
* use of corticosteroids or other medication that would potentially affect the nutrient metabolism or excretion of biomarkers of interest,
* presence of food allergy or intolerance that requires a special diet,
* pregnancy and lactation,
* excess physical activity (\>5h/week of high intensity),
* current participation in another trial
A Phase I Study of Bendamustine and Melphalan Conditioning and Autologous Stem Cell Transplantation for Treatment of Multiple Myeloma and Relapsed/Refractory B-cell Lymphoma in Elderly Patients

This study is testing a combination of chemo-immuno therapy called RBM. RBM consists of combination of drugs: rituximab, bendamustine, and melphalan followed by reinfusion of the participants own stem cells which is called autologous stem cell transplant (ASCT). Compared to the standard BEAM regimen, this RBM regimen may or may not be less effective in lymphoma, but will likely have fewer side effects.


Eligibility Criteria:
Inclusion Criteria:

Phase I eligibility:

* Any patient with multiple myeloma B-cell non-Hodgkin lymphoma would be eligible for phase I portion of the study.

Dose expansion eligibility:

* Histologically confirmed diagnosis of multiple myeloma or rel/ref DLBCL, or diffuse large B cell lymphoma transformed from an indolent lymphoma Since the endpoint of the Phase I portion is safety, any patient with myeloma or B-cell NHL can be enrolled. For dose expansion study patients with myeloma and B-NHL will be analyzed separately. The PFS endpoint varies greatly amongst different types of lymphoma. In order to accurately interpret the survival data as secondary endpoint, a homogeneous cohort of patients with DLBCL will be evaluated. DLBCL is the most aggressive B-NHL with limited options. Other B-NHL's are generally more indolent and have more options available to them.

Additional eligibility for both the phase I and dose expansion cohort:

* Patients between the ages of 65 to 69 years old with a Hematopoietic Stem Cell Transplant Comorbidity Index (HCT-CI) score of 3 or higher.
* Any patient age 70 years old or older, irrespective of their Hematopoietic Stem Cell Transplant Comorbidity Index (HCT-CI) score.
* KPS ≥ 70
* Males must agree to use an acceptable form of contraception per institutional practices.
* Complete or partial response to salvage chemotherapy by IWG Working Group Criteria
* Cardiac ejection fraction of ≥ 45%
* Hemoglobin-adjusted diffusing capacity of carbon monoxide (DLCO) of ≥45%
* Creatinine clearance of ≥50 mL/min
* Completion of most recent salvage therapy within 8 weeks of enrollment
* Direct bilirubin ≤2.0 mg/dL in the absence of suspected Gilbert's disease (if Gilbert's disease is suspected, the total bilirubin must be ≤3.0 mg/dL), and AST ≤ 2.5 ULN.

Exclusion Criteria:

* In Lymphoma: Disease progression by IWG Working Group Criteria since last therapy
* Patients with history of CNS involvement
* Prior autologous (only in lymphoma) or allogeneic stem cell transplantation
* Patients who have failed bendamustine-based regimen previously
* Patients within 6 months of MI and stroke will be excluded
Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope

The purpose of the study is to compare the success rates of procedure success and complication rates in patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using two types of currently available endoscopes. These are (1) duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope.

The risks associated with the ERCP procedure will be explained to patients who meets the eligibility criteria. Consenting patients will be randomized to undergo Endoscopic retrograde cholangiopancreatography (ERCP) using either (1) a duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope. Assessments will be made during, and immediately after the procedure, then patients will be called after 1 week, 1 month, and 3 months after the procedure to get information about adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing ERCP for biliary and pancreatic conditions
* Age \> 18 years old

Exclusion Criteria:

* Vulnerable patient groups including pregnant women
* Patients who are unable to consent
* Patients with known cholangitis
* Patients with known Carbapenem-Resistant Enterobacteriaceae (CRE) or any other multi-drug resistant organisms (MDRO) infection
* Surgically altered anatomy except for Billroth I
Photodynamic Therapy Using Porfimer Sodium in Treating Patients With Recurrent Mouth or Throat Dysplasia or Recurrent In Situ Cancer or Stage I Cancer of the Mouth or Throat

RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Photodynamic therapy using porfimer sodium may be effective against mouth or throat dysplasia and cancer of the mouth and throat.

PURPOSE: This phase I trial is studying how well photodynamic therapy using porfimer sodium works in treating patients with recurrent mouth or throat dysplasia, recurrent in situ cancer of the mouth or throat, or stage I cancer of the mouth or throat.

OBJECTIVES:

* To determine the response of patients with recurrent dysplasia, squamous cell carcinoma in situ, or stage I squamous cell carcinoma of the oral cavity or the larynx treated with photodynamic therapy using porfimer sodium.
* To identify the local toxicity of this treatment in these patients.

OUTLINE: Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber. Patients with incompletely treated or missed sites of disease may receive another dose of laser light on day 5 without additional porfimer sodium. Patients with multicentric disease may undergo additional PDT at least 4-6 weeks after the initial treatment.

After completion of study therapy, patients are followed for 1-2 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Biopsy confirmed oral cavity or larynx lesion with mild-to-severe dysplasia OR in situ or stage I (T1, N0) squamous cell carcinoma of the oral cavity or larynx
* Recurrent disease

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* WBC ≥ 4,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Total bilirubin ≤ 2.0 mg/dL
* Creatinine ≤ 2.0 mg/dL
* Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)
* SGOT ≤ 3 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must practice effective contraception
* No porphyria or hypersensitivity to porphyrin or porphyrin-like compounds

PRIOR CONCURRENT THERAPY:

* Any type of prior therapy allowed
* More than 4 weeks since prior and no concurrent chemotherapy or radiotherapy
Montelukast for Persistent Cough in Young People and Adults

Persistent cough is a common symptom, accounting for about 20% of referrals to outpatient chest clinics. Most coughs are caused by self-limiting viral infections such as the common cold. However, 1 in 4 people with a viral infection develop a persistent cough, which can go on for several weeks. Whooping cough is a common cause of persistent cough in young people and adults. Although the whooping cough vaccine gives lifelong protection against severe infection, it does not appear to give such long-term protection against milder infections, which can make someone cough for many weeks. There are currently no proven efficacious treatments for persistent cough following either a viral infection or infection with whooping cough.

Montelukast is a medication which is already licensed for the treatment of asthma. It works by blocking the action of chemicals called leukotrienes, which make the airways of people with asthma inflamed and sensitive. There is strong evidence to suggest that leukotrienes are also involved in causing persistent cough following viral or whooping cough infection. Montelukast may therefore also help settle persistent coughs in these settings.

Over 18 months, we will recruit patients aged 16-49 years with a cough lasting 2-8 weeks from general practices in England. An oral fluid sample will be taken from each participant to be tested for whooping cough. Participants will be randomly allocated to receive a 28-day course of montelukast or placebo tablets and asked to complete a daily cough diary for two weeks. They will be assessed after two weeks by their GP (face-to-face) and after four weeks by another member of practice clinical staff (telephone). Some participants will be given a 24-hour cough monitor to wear on study entry and at two-week follow-up. This study will be funded by the National Institute for Health Research's School of Primary Care.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female, aged 16 years to 49 years inclusive.
* Presenting with a persistent cough of 2-8 weeks' duration without an established diagnosis (e.g. asthma, gastro-oesophageal reflux).
* Able to complete cough diary and study questionnaires.

Exclusion Criteria:

* There is a contraindication to montelukast.
* Chronic severe disease which may cause persistent cough (eg cystic fibrosis, bronchiectasis, cardiac failure).
* Immunodeficiency/immunocompromised state.
* Pregnancy.
* Breastfeeding.
* Current smoker (i.e. stopped smoking less than 6 months ago).
* Regular medication associated with persistent cough (ACE inhibitors).
* The individual is in another clinical research study.
REmote iSchemic Conditioning in acUtE BRAin INfarction Study

Cerebral infarction is the most common form of stroke (80% of strokes). Stroke is the first cause of acquired disability, and the 2nd cause of dementia and death. The only approved treatment in the first 4.5 hour is intravenous rt-PA thrombolysis (Actilyse ®) whose objective is recanalization of occluded artery and reperfusion of the brain parenchyma. Few patients are treated (1-5%) and they keep disability in 50-60% of cases. This handicap is mainly correlated to the final infarct size. The objective of neuroprotective treatments is to reduce the final size of the cerebral infarction.

The per-conditioning remote ischemic (Per-CID) showed a neuroprotective effect in cerebral ischemia by reducing the final size of cerebral infarction animal models. The per-CID corresponds, in cases of cerebral ischemia, to iterative ischemia realization of a member with a cuff. In humans, the per-CID has shown a cardioprotective effect in a randomized control trial involving 250 patients within 6 first hours of myocardial infarction and candidate for primary angioplasty.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years
* Carotid ischemic stroke
* NIHSS score between 5 and 25
* Brain MRI performed within 6 hours from symptoms onset
* Obtaining a written informed consent of the patient or a third party (parent or close), or emergency inclusion process
* Affiliated with a Medicare (or rightful beneficiary)

Exclusion Criteria:

* Presence of a leg ulcer or a bad skin condition in the lower limbs
* History of arterial occlusive disease of the lower limbs
* Sickle cell disease known (risk of vaso-occlusive crisis)
* History of phlebitis in the lower limbs
* History of cerebral infarction older than 3 months
* Participation in another interventional acute phase protocol
* Patients under guardianship
* Pathologies involving life-threatening within 6 months and making it impossible to evaluate to 3 months
* Patient non-self before the ischemic stroke (Rankin Score previous\> 2)
* Pregnant Women
Effects of Ketogenic Diet on Body Composition and Performance in Soccer Players

A ketogenic diet (KD) is a nutritional approach, usually adopted for weight loss, that restricts daily carbohydrates under 30 g/day. KD showed contradictory results on sport performance, whilst no data are available on team sports. The investigators will investigate the influence of a KD on different parameters in soccer players

Sixteen semi-professional soccer players will be randomly assigned to a ketogenic diet (KD n=8) or to a western diet (WD n=8). Diets contain the same amount of protein (1.8g/Kg body weight/day). Body weight and body composition will be measured by dual energy x-ray absorptiometry (DXA) and bioelectrical impedance analysis (BIA). Resting energy expenditure (REE), respiratory exchange ratio (RER), cross sectional area (CSA) and isometric muscle strength of quadriceps, counter movement jump (CMJ) and yoyo intermittent recovery test will be measured.

Eligibility Criteria:
Inclusion Criteria

* semiprofessional soccer players
* male

Exclusion Criteria:

* body fat percentage over 32%, (determined via dual energy X-ray absorptiometry DEXA),
* cardiovascular,
* respiratory, gastrointestinal,
* thyroid or any other metabolic diseases,
* weight change more than 2 Kg over the last month,
* adherence to special diets,
* use of nutritional supplements (except a daily multivitamin-mineral)
* use of medication to control blood lipids or glucose and goal-keepers.
Falls Among the Older Patients Treated for Cancer in Normandy's Outclinics: Screening and Prevention

The French Plan National AntiChute (published on February 21, 2022) and international recommendations on falls prevention (Age Ageing,September 2022) recommend identifying the risk of falling in people aged 65 and over, at least once a year during a follow-up consultation. The presence of chronic illness such as cancer increases the risk for falling. Recommendations suggest targeted preventive interventions according to the risk level, and early reassessment at 3 months in case of high risk.

This study consists of a cross-sectional survey conducted during a week dedicated to patient safety (September 16-20, 2024), to identify the prevalence of patients at high risk for falling, requiring enhanced care. The relation between high risk for falling and social and oncological characteristics will be studied. A 3-month telephone follow-up will identify any obstacles to implementing the recommendations in this high-risk group.

This multicenter cross-sectional prospective study is exploratory.


Eligibility Criteria:
Inclusion Criteria:

* aged 65 or over
* undergoing treatment for cancer or hematological malignancy (oral or injectable systemic treatment, radiotherapy)
* covered by health insurance
* having read the information document and no objection
* French-speaking
* Autonomous ( with occasional assistance with instrumental daily activities),

Exclusion Criteria:

* refusal to participate
* unable to communicate
* dependent (requiring geriatric care)
Optimisation of Hybrid Fittings for Cochlear Implant Recipients

When providing amplification post-implantation to residual acoustic hearing in the implanted ear, the lower frequency boundary can be modified to minimize or avoid overlap between the frequencies coded through acoustic hearing and those presented through electrical stimulation. This boundary is termed the cross-over frequency (Fc) and the effect of modifying this parameter will be investigated in this study. To avoid the research being confounded by prior bias for a particular frequency allocation, the study will be conducted with newly implanted recipients.

This study will also investigate whether tests which measure the ability to use low frequency hearing and objective measures can predict the preferred Fc and speech performance benefit.


Eligibility Criteria:
Inclusion Criteria:

1. Adult (≥18 years of age)
2. Post-operative residual hearing in the implanted ear (defined as having an unaided threshold better than or equal to 80 dB HL at the 500 Hz frequency).
3. Implanted with the CI500 or CI24RE-series cochlear implants
4. User of the commercially available Nucleus 6 sound processor
5. User of the ACE strategy
6. Native speaker in the language used to assess speech perception performance
7. Willingness to participate in and to comply with all requirements of the protocol

Exclusion Criteria:

1. Additional handicaps that would prevent participation in evaluations
2. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device
Sema 4A as a Marker for Inflammatory Disease in Multiple Sclerosis

Measure serum and cerebrospinal fluid Sema4A levels in female subjects with newly diagnosed and untreated relapsing multiple sclerosis, clinically stable relapsing multiple sclerosis receiving disease modifying therapy, relapsing multiple sclerosis receiving disease modifying therapy with breakthrough disease, or non-multiple sclerosis controls (patients without inflammatory central nervous system disease).

This pilot study proposal will further investigate whether Semaphorin 4A (Sema4A) elevation in cerebrospinal fluid (CSF) and serum is a potential disease activity biomarker in patients with multiple sclerosis (MS).

A total of 40 female subjects between the ages of 18-55 who meet the criteria of one of the following four groups will be enrolled to measure serum and CSF Sema4A levels:

* Group 1: Newly diagnosed/untreated Relapsing MS patients (RMS)
* Group 2: Clinically stable RMS patients receiving disease modifying therapy (DMT)
* Group 3: RMS patients receiving DMT with breakthrough disease
* Group 4: Non-MS controls (patients without inflammatory CNS disease)

Participants will provide blood and CSF samples at baseline for Sema4A analysis. Follow up blood samples will be collected at 6 months and 12 months as part of lymphocyte subset analysis. Participation will end after 12 months of follow up.

The expected risks are related to blood draws and lumbar puncture. Lumbar puncture will be performed under fluoroscopy to decrease risks of pain from repeated needle punctures, injury from incorrect placement of the needle, and post puncture CSF leakage.

Eligibility Criteria:
Inclusion Criteria:

* Female aged 18-55, inclusive at the time of consent
* Not pregnant at the time of the screening/baseline visit
* Able to understand the purpose, benefits, and risks of the study; willing and able to adhere to the study requirements; able and provide informed consent in English
* Meet the criteria of one of the four groups at the time of consent:

  * Group 1: subjects who have recently been diagnosed with MS, have had a clinical attack within the last 6 months, have not received steroids in the last 30 days, and have not started on a disease modifying therapy
  * Group 2: subjects with clinically stable relapsing MS, with no evidence of clinical relapse for at least the past 12 weeks, and have no gadolinium enhancing lesions on MRI in the prior 4 weeks, who are receiving a FDA-approved MS DMT
  * Group 3: subjects with relapsing MS on a FDA-approved DMT but with evidence of breakthrough disease, with a documented clinical relapse and/or gadolinium-enhancing lesion(s) on brain or spinal cord MRI taken within the 4 weeks
  * Group 4: subjects without evidence of inflammatory systemic or CNS disease, who require CSF removal for some other cause, such as for idiopathic intracranial hypertension or communicating hydrocephalus

Exclusion Criteria:

* There are no exclusion criteria for this study.