cyrilzakka/clinical-trials huggingface dataset:
NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)

The safety and efficacy of a chewable formulation of extended-release methylphenidate will be studied in children with ADHD


Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this condition

Exclusion Criteria:

* Other serious illnesses or conditions that would put the patient at particular risk for safety events or would interfere with treatment/assessment of ADHD
A Study To Evaluate The Safety And Efficacy Of Tofacitinib Modified Release Tablets Compared To Tofacitinib Immediate Release Tablets In Adult Patients With Rheumatoid Arthritis

This is a 12 week study that will evaluate the efficacy and safety of the 11 mg tofacitinib modified release tablet taken once a day in patients with rheumatoid arthritis who continue taking methotrexate. Results for the modified release tablets will be compared to the efficacy and safety of the 5 mg tofacitinib immediate release tablets taken twice a day in patients with rheumatoid arthritis who continue taking methotrexate.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of rheumatoid arthritis
* currently taking a stable dose of methotrexate
* no evidence of active or latent or inadequately treated tuberculosis

Exclusion Criteria:

* evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease
* clinically significant infections within the past 6 months
Extraction of Stromal Vascular Fraction and Stem Cells From Fat Tissue

Human Adipose Tissue is considered as a new source for Stromal Stem Cells and offers a large therapeutic potential for many rare and common diseases that impacts millions of patients worldwide. The Stromal Vascular Fraction (SVF) of Adipose Tissue is relatively easy to extract with minimally invasive procedures such as elective liposuction in large quantities and therefore may be a cost effective source for cellular therapies in a wide range of medical specialties. In this study we aim to demonstrate the efficacy of Antria Cell Preparation Process© in obtaining human adipose derived Stromal Vascular Fraction (SVF) by performing histology, various cell counts, multiple surface marker tests and measurement of the residual amount of digestive enzymes as a safety measure for human clinical trials.


Eligibility Criteria:
Inclusion Criteria:

Male or Female Age: 18 - 65 Scheduled for Liposuction Procedure Able to understand and provide written informed Consent

Exclusion Criteria:

Diagnosis of any of the following medical conditions:

Active malignancy (diagnosed within 5 years) except for adequately treated non-melanoma skin cancer or other non-invasive or in-situ neoplasm (e.g. cervical cancer) Active Infection Chronic use of NSAID's or Steroids On Radiotherapy or Chemotherapy agents Any other disease or condition that may alter the accuracy of study results (e.g. Severe Osteoporosis, Rheumatoid Arthritis and other autoimmune disorders)
From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices

This study is designed to support evidence-based practice and optimal care by evaluating how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influences outcomes following traumatic lower extremity injury.

This study is designed to evaluate how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influence outcomes following traumatic lower extremity injury. In this study, adult participants who still experiencing deficits including weakness and/or immobility more than two years post traumatic lower extremity injury will be randomized and fit with either modular or monolithic CDO.

Participants will then be evaluated without a CDO and with the CDO in three configurations in a randomized order: a proposed optimal benchmark configuration, a variation with the device in more dorsiflexion, and a variation with the device in greater plantarflexion. Multiple well-established tests will be used to compare outcomes between the different configurations.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 65
* 2 or more years from a traumatic injury below the knee
* Ability to be fit with an orthosis
* Any of the following:

  * Weakness of ankle plantarflexors (\<4/5 on manual muscle test)
  * Limited pain-free ankle motion (dorsiflexion (DF) \<10° or plantarflexion (PF) \<20°)
  * Mechanical pain with loading to hindfoot/midfoot (\>=4/10 Numerical pain rating scale)
  * Fusion or candidate for fusion of the ankle or hindfoot
  * Candidate for amputation secondary to ankle/foot injury and impairment

Exclusion Criteria:

* Pain greater than 8/10 at rest
* Ankle weakness or spasticity as a result of spinal cord injury or central nervous system pathology
* Use of an orthosis including the knee
* Non-ambulatory
* Surgery on study limb anticipated in next 4 months
* Medical or psychological conditions that would influence functional testing (e.g., severe traumatic brain injury, stroke, heart disease, vestibular disorder)
* Neurologic, musculoskeletal, or other conditions limiting function of the contralateral extremity
* Uncorrected visual or hearing impairments
* Pregnancy
* Non-English speaking
* BMI \> 40
Efficacy of Metformin for Sputum Conversion in Patients With Active Pulmonary Tuberculosis

This study was a randomized controlled trial studying about acid-fast bacillus sputum conversion ratio from positive to negative of pulmonary tuberculosis patients between metformin with pulmonary tuberculosis standard treatment group and placebo drug with pulmonary tuberculosis standard treatment.

1. Pulmonary tuberculosis Patients with presence of at least one acid-fast bacillus in the sputum will be examined by an internist.
2. Collect the necessary basic information of patients who agree to participate in the treatment such as complete blood count, blood urea nitrogen, creatinine, liver function test, fasting plasma glucose, hemoglobinA1C, lactate, and gene expression signature for tuberculosis.
3. Patients will be randomized into 2 groups: those who will receive metformin with pulmonary tuberculosis standard treatment and those who will receive placebo drug with pulmonary tuberculosis standard treatment.
4. Patients will get a chest x-ray and collect sputum acid fast bacillus, sputum culture for tuberculosis and collect blood sample laboratory such as complete blood count, liver function test, creatinine, fasting plasma glucose, lactate, and gene expression signature for tuberculosis at second week.
5. Patients will get a chest x-ray and collect sputum acid fast bacillus, and sputum culture for tuberculosis at second month.
6. Patients will get a chest x-ray and collect sputum acid fast bacillus, and sputum culture for tuberculosis at fifth month.
7. Patients will get a chest x-ray and collect sputum acid fast bacillus, and sputum culture for tuberculosis at sixth month.
8. After collecting all information of patients, Investigators will analyze in clinical and statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years old
* Be diagnosed pulmonary tuberculosis compatible with clinical and chest x ray by an internist
* Presence of at least one acid -fast bacillus in the sputum
* Recieve pulmonary tuberculosis standard treatment compose of isoniazid, rifampicin, pyrazinamide and ethambutol
* BMI more than 18.5 kg/m2
* Reserach participants were diagnosed diabetes or non diabetes.
* Research participants or representatives are welcome to join the project by signing.

Exclusion Criteria:

* Pregnancy
* Organ transplants
* eGFR less than 45 ml/min/1.73 m2
* AST, ALT or total bilirubin more than three times
* Researh participants have received metformin at least 2 weeks before joining the project.
* Immunocompromised host such as patient receive systemic immunosuppressive drugs or systemic chemotherapy.
* Research participant or his representative refuses or requests to withdraw,
Per-operative Exploration of the Peri-pancreatic Lymphatic Pathways During Pancreatic Surgical Resection

Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis (Limit : 5000 characters) Pancreatic cancer has a poor prognosis. Surgical resection is the only curative treatment. Major pancreatectomies lead to high postoperative morbidity rate, up to 30%. For some tumors, limited resection are increasedly performed, but the rate of pancreatic fistula is even higher, up to 40%.

No precise "anatomic" pancreatic segmentation currently exists. If such segmentation is described, pancreatic resections, major of minor, may have better outcomes.

The aim of this study is to demonstrate the existence of independent pancreatic segments, following the lymphatic drainage of the gland.

Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures. (Limit : 32 000 characters) The prognosis and life expectancy for people with pancreatic cancer remain very low (3rd cause of mortality among all cancer). Surgical resection is the only curative treatment, whenever possible. Nevertheless, major pancreatectomies lead to high postoperative morbidity rate, in particular up to 30% fistula rate. In case of parenchyma-sparing procedures, this rate is even higher, up to 40%.

One of the reasons of these high rates might be explained by the fact that pancreatic transections are currently not performed following pancreatic segmentation. If possible, resection following vascular segmentation would prevent necrosis of the transection, resection following lymphatic segmentation would improve the lymph-node dissection, and resection following pancreatic-duct segmentation would prevent leakage from pancreatic duct stump. Nevertheless, no precise "anatomic" pancreatic segmentation currently exists.

On the other hand, the lymphatic system of the pancreas is highly complex, but the quality of the lymphadenectomy during pancreatectomy is essential since the recurrences almost always occur on the lymphatic transections. A better knowledge of the peri-pancreatic lymphatic vessels is still required.

The aim of this study is to demonstrate the existence of independent pancreatic segments, following the lymphatic drainage of the gland.

Eligibility Criteria:
Inclusion Criteria:

* All patient operated on for pancreatic resection
* Patients consenting the protocol after clear and loyal explanations

Exclusion Criteria:

* history of first abdominal surgery in the upper part
* Patients with peritoneal carcinomatosis
Cartilage Recovery in Adults With Knee Osteorthritis by Mesenchymal Cell Therapy: Randomized Trial of Radiologic and Clinical Outcomes

The treatment of osteoarthritis (OA) of the knee remains still controversial. Despite that fact advanced stages with symptomatic and functional improvement are obtained with total knee replacement, however, there is no treatment that neither modifies the natural history of this disease, nor avoid joint replacement surgery in young patients in whom the prosthesis has conflictive indications. Moreover, prosthetic surgery leads to lower long-term survival and in older patients, higher morbidity and mortality. Cell therapy promises to be a treatment option through the use of mesenchymal cells with the capacity control inflammatory responses and trigger the differentiation into chondrocytes. Here we propose a randomized placebo-controlled clinical trial to evaluate radiologic and clinical outcomes in patients with knee OA.


Eligibility Criteria:
Inclusion Criteria:

Pain most days for the last month. Presence of osteophytes. Synovial fluid with mechanical characteristics. Morning stiffness for less than 30 minutes in the affected joint. Patellar crepitus. Patients aged 40 years or older and less than 60 years. Radiological criteria for osteoarthritis of the knee Kellgren-Lawrence 2 to 4 in comparative radiographs with knee support taken in the last 12 months prior to consultation.

Pain in one or both knees according to a visual analogue scale of 5 or more, out of 10 points in the last 3 months.

Exclusion Criteria:

Consumption of non-steroidal anti-inflammatory drugs or anticoagulants in the last 14 days.

Patient with a history of joint infiltration or arthroscopic surgery of the affected knee in the last 6 months.

Participants in another treatment or research study within the past year. Pregnant or lactating patients. Patient with active tumor pathology or a history of oncological disease. Patient with metabolic disease and/or uncontrolled coagulopathy at the assessment time.

Patients who have received previous treatments such as microfractures, and osteochondral allografts.

Patients with present meniscal lesions. Patients with a history of thyroiditis or thyroid nodules with increased antithyroglobulin antibodies.

Patients with a history of osteoarticular infection in the last 5 years or active at the time of assessment.
Infusion of Depleted T Cells Following Unrelated Donor Stem Cell Transplant (ICAT)

The purpose of this study is to evaluate whether the administration of allodepleted donor T cells to patients with haematological malignancies after stem cell transplant can improve the recovery of the patients immune system.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥16 years
* Underlying haematological malignancy
* Planned allogeneic peripheral blood stem cell transplantation from a 10/10 or 9/10 HLA matched unrelated donor, using an Alemtuzumab-based conditioning protocol
* Written Informed consent

Exclusion Criteria:

* Life expectancy \< 6 weeks
* Female patients who are pregnant and lactating
* Patients who are serologically positive for Hepatitis B, C or HIV pre-SCT
Randomized, Double Blind Trial of the Quadrivalent HPV Vaccine to Improve Responses to LEEP Treatment of Cervical HSIL

Cervical cancer occurs commonly in HIV-infected women in South Africa. These women have poor response to treatment of cervical cancer precursors. This study will test whether giving the quadrivalent vaccine to women prior to surgical treatment of the cervical cancer precursor will improve outcomes. We hypothesize that pre-treatment HPV vaccine will result in a reduced occurrence or cervical cancer precursors in follow-up.

This is a single-center, randomized, double-blinded, placebo-controlled, phase II trial of the quadrivalent human papillomavirus vaccine (qHPV) in HIV-infected women to prevent occurrence of cervical HSIL after LEEP/LLETZ. Participants will undergo colposcopy with directed biopsies, cervical cytology, and stored HPV testing prior to vaccination. Participants will be randomized to the quadrivalent vaccine or saline placebo to be given at entry, week 4, and week 26. Women will have LEEP treatment at week 4. Participants will be seen in follow-up for cervical cytology, colposcopy with directed biopsies at weeks 26 and 52, and stored HPV specimens. Treatment assignment will be unblinded after study follow-up is completed for the last study participant. Women aged 45 or less randomized to placebo will be offered open label HPV vaccine after the study is concluded..

Eligibility Criteria:
Inclusion Criteria:

1. HIV infection
2. Women aged ≥ 18 years.
3. Cervical HSIL on biopsy (i.e. CIN2 and/or CIN3)
4. For participants of reproductive potential, negative serum or urine pregnancy test
5. All study participants must agree not to participate in a conception process (e.g., active attempt to become pregnant or in vitro fertilization) during study participation (from the time of study entry until week 52).

Exclusion Criteria:

1. History or current biopsy diagnosis of invasive or microinvasive cervical, vaginal, vulvar, anal or oropharyngeal cancer
2. Prior hysterectomy
3. Cervical cryotherapy or LEEP/LEETZ within one year of entry.
4. Cervical, vulvar, or vaginal lesions suspicious for cancer, unless biopsies show no invasive cancer
5. Prior receipt of one or more doses of an HPV vaccine.
6. Receipt of anticoagulants other than aspirin or nonsteroidal anti-inflammatory drugs (NSAIDS) within 14 days prior to entry.
7. Known allergy/sensitivity or any hypersensitivity to yeast or any of the components of the study product or its formulation (see section 5.2 for a list of components).
8. Hemophilia or other bleeding diatheses.
9. Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, other than inhaled corticosteroids or prednisone ≤ 10 mg (or equivalent) , investigational vaccines, interleukins, interferons, growth factors, or intravenous immunoglobulin (IVIG) within 45 days prior to study entry.
10. Breastfeeding
11. Less than 3 months post-partum
Passive Immunotherapy In Patients With SARS CoV-2

Plasma from convalescent individuals (convalescent plasma, CP) has been used for more than a hundred years for the treatment of infectious diseases. Among patients with COVID-19, it has been used first, in patients with severe infection. Although it is a safe treatment, it has not been possible to demonstrate a reduction in mortality in cases of acute respiratory distress syndrome.

The objective of the clinical trial is to evaluate the efficacy and safety of the early use (less than 5 days of symptoms) of CP in patients infected with SARS-CoV-2 with risk factors for severe disease.

The primary efficacy endpoint was the proportion of patients requiring oxygen therapy to maintain saturation \>93% on day 14. Secondary objectives included, evaluation of the safety of the treatment, measured as the appearance of some adverse event related to the CP infusion; the evolution of COVID-19 symptoms and WHO progression scale status at day 14 and 28 after inclusion; the need for hospitalization due to progression of COVID-19. COVID-19 progression was considered as worsening of respiratory symptoms requiring oxygen therapy at some point. Finally, death from any cause was evaluated at 28 days, after inclusion in the study.


Eligibility Criteria:
Inclusion Criteria:

Patients with SARS-CoV-2 infection, confirmed by any validated microbiological technique, and with one or more symptoms associated with COVID-19 with ≤5 days of evolution and with an oxygen saturation ≥93% breathing room air.

In addition, the patients had to present some risk factor for severe disease:

* Chronic heart failure (NYHA ≥ 2)
* Arterial hypertension under pharmacological treatment
* Chronic lung disease: COPD (bronchitis, emphysema or chronic obstruction) with dyspnoea at least on moderate exertion, or moderate-severe asthma (that required inhaled corticosteroids to control symptoms or had received systemic corticosteroids during the last year due to decompensation)
* Chronic renal failure (glomerular filtration rate \<60 ml/min/1.73 m², by CKD- ILD)
* Diabetes mellitus requiring pharmacological treatment or obesity grade ≥ I (BMI ≥30 Kg/m2).
* Patients ≥65 years were included, regardless of other risk factors.

Exclusion Criteria:

* Duration of symptoms \>5 days
* Dyspnoea at rest
* Need for supplemental oxygen to maintain O2 saturation \>93%
* Solid neoplastic or haematologic disease (except skin cancer) with active treatment in the last 3 months before the onset of symptoms
* Patients under chronic corticosteroid treatment (equivalent to prednisone 10 mg/d for at least 28 days) or immunosuppressive treatment
* Decompensated liver cirrhosis
* Participation in another clinical trial
* History of hypersensitivity to haematological derivatives
* Pregnancy or lactation,
* AST/ALT \>5 times the upper limit of normal or at baseline in patients with chronic liver disease
* Any condition that in the opinion of the investigator limits participation in the study.
* Patients who had received monoclonal antibodies against SARS-CoV-2
Analysis of Visual Pathways in Glaucoma Patients Using a 3tesla-MRI

Glaucoma is a neurodegenerative disease representing the second cause of blindness worldwide. IOP (Intra occular pressure) is the most common risk factor, but not the only one as it is observed for normal tension glaucoma. Some studies have reported lesions of the optical pathways on MRI examination MRI 3T (Magnetic Resonance Imaging 3 Telsa), by increasing spatial resolution and DTI (diffusion tensor Imaging)with fractional anisotropy could help us to analyze visual pathways and to determine the association with neurodegenerative diseases as Alzheimer.

The investigators propose to compare volume and structure of the visual pathways between glaucoma patients and healthy subjects matched on age and sex.

Glaucoma is a neurodegenerative disease characterized by loss of retinal ganglion cells, visual field deterioration and optic nerve cupping. Some studies have suggested that all the visual pathways could be damaged in glaucoma. Recently, a German study proved a significant reduction of volume of the optic radiations in glaucoma versus healthy subjects in MRI 3T. Some authors have also suggested that glaucoma could share similarities with the other neurodegenerative diseases like Alzheimer's disease. MRI 3T and DTI allow studying visual pathways with a high level of spatial resolution.Fractional anisotropy is a tag of microstructure.


Eligibility Criteria:
Inclusion Criteria:

* for cases : Age over 40 years-old, glaucomatous lesion of the optic nerve head with cup/disc ratio, visual field loss, and minimental state superior or equal to 28/30
* for healthy subjects/ matched on age and sex, no individual or familial history of glaucoma, IOP less than 21mmHG, minimental state superior or equal to 28/30

Exclusion Criteria:

* Ocular hypertension, optic nerve disease, visual field loss, diabetes, Horton disease, ocular diseases, immunologic diseases, neuropsychiatric diseases, MRI contraindication (pace maker)
Pharmacodynamics and Tolerance of Nicotinamide Mononucleotide (NMN, 400mg/Day) in Healthy Adults

The purpose of this study is to evaluate the physiological and/or biological actions of nicotinamide mononucleotide (NMN-C) in healthy adults receiving a repeated-dose over the course of 28 days by studying the tolerance and pharmacodynamics of this product.


Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers should be

* Men between the ages of 30 and 60 years old
* With a BMI between 23 and 30 kg/m2
* With a weight \> or = 70kg
* Giving their free informed consent to the study

Exclusion Criteria:

May not be included in the study Volunteers with

* a history of allergy to vitamin B3 (niacin or nicotinamide)
* immunocompromised or suffering from a serious or progressive disease (cardiac, pulmonary, hepatic, renal, hematologic, neoplastic or infectious)
* with abnormal results on the screening bioassay (CBC, Transaminases (AST, ALT, GGT), Bilirubin, Creatinine, CPK, Ionogram, Blood glucose, Hba1c, Lipid profile)
* having donated blood in the month preceding inclusion,
* having consumed more than 2 glasses of alcohol per day,
* being under medication or taking food supplements,
* having reached the maximum compensation threshold for research involving the human being as provided for by the regulations or having participated in another biomedical research project that required blood samples in the previous month,
* involved in another clinical trial or being in the exclusion period of a previous clinical trial.
Eliquis Regulatory Post Marketing Surveillance (rPMS)

The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the clinical usefulness of Eliquis through collecting, reviewing, identifying and verifying the safety and effectiveness information about Eliquis in general practice


Eligibility Criteria:
Inclusion Criteria:

* Signed data release
* Patients undergoing elective total hip replacement arthroplasty or elective total knee replacement arthroplasty

Exclusion Criteria:

* Being treated for an indication not approved for the use of Eliquis® in Korea
* Is contraindicated for the use of Eliquis® as described in the Korean label