cyrilzakka/clinical-trials huggingface dataset:
Construction of Diagnosis System for Early AD Based on Multi-Modality MRI Technology

One purpose of this study is to construct the diagnosis system for early Alzheimer's disease(AD), which is also called amnestic mild cognitive impairment (aMCI), and then further construct the predictable classifier from aMCI to AD based on Multi-Modality MRI characteristics of aMCI patients.

The cognition of aMCI is between normal aging and dementia, which is thought the transitional stage of dementia. Patients with aMCI have heavy risk to convert to AD, so in this study, the investigators focus on the construction of the diagnosis system for early AD based on multi-modality MRI characteristics of aMCI patients. Every patient underwent β-Amyloid PET, fluorodeoxyglucose-PET(FDG-PET), structural MRI, diffusion tensor imaging and functional MRI. Then investigators further study the patients who convert to AD and explore their MRI and metabolism characteristics on baseline, in order to construct the predictable classifier from aMCI to AD. The investigators want to achieve the early diagnosis of AD and help clinicians interfere with the progress of this disease.

Eligibility Criteria:
Inclusion Criteria:

* Memory loss complaint and confirmed by an informant
* Cognitive impairment in single or multiple domains, adjusted for age and education
* Normal or near-normal performance on general cognitive function and no or minimum impairment of daily life activities
* A Clinical Dementia Rating (CDR) score is 0.5 and consistent with the boundary of neuropsychological scale
* Failure to meet the criteria for dementia
* Must be able to accept examination of MRI, sight and hearing allow to complete test
* Right handedness

Exclusion Criteria:

* Other diseases that cause cognitive impairment, such as thyroid disease, stroke and so on
* People who have severe visual and hearing impairment
Brief Nurse-led Mindfulness Based Intervention

This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The feasibility, acceptability, and clinical effects of the nurse-led, very brief, preoperative mindfulness based intervention for hip and knee replacement patients will be investigated relative to nurse-led preoperative pain psychoeducation.

A secondary sub-analysis will compare two different styles of mindfulness practice (mindfulness of breath vs. mindfulness of pain) relative to preoperative pain psychoeducation.


Eligibility Criteria:
Inclusion Criteria:

* 1) Age ≥18,
* 2) Scheduled to undergo unilateral total knee arthroplasty

Exclusion Criteria:

* 1) Cognitive impairment preventing completion of study procedures.
* 2) Current cancer diagnosis,
* 3) Contralateral knee replaced in the previous 3 months,
* 4) Intent to have contralateral knee replaced or other, additional surgical procedure during the study period,
* 5) Intent to add new pain treatments during the study period (except for what is part of the study),
* 6) Other unstable illness judged by medical staff to interfere with study treatment.
Airway Redox and Gender Determinants in Severe Asthma

The investigators will study the biologic and chemical differences that cause the greater incidence, and severity of asthma in women as compared to men. Severe asthma affects boys more than girls, while severe asthma in adults is predominantly a disease of women. The investigators aim to identify the processes that occur in the body that are behind the onset of severe asthma in young women during the teenage years, and the resolution of severe asthma in boys. To further evaluate gender influences on asthma, asthmatic women at different stages of their menstrual cycle (period) will be also studied. The investigators aim to use biomarkers to develop testing procedures that will identify different types or characteristics of asthma in men and women; and to follow patients over time to uncover relevant clinical outcomes of biomarkers. The investigators anticipate that they will 1) develop clinically relevant tests to identify unique types or characteristics of asthma and severe asthma; 2) determine outcomes over time of biochemically-defined types of asthma; and 3) identify the reasons for why adult women are affected more than men with severe asthma.

This scientific site-specific project is part of a larger network of asthma studies, the Severe Asthma Research Program (SARP). The mission of SARP is to improve the understanding of severe asthma to develop better treatments.

Eligibility Criteria:
Inclusion Criteria:

Subjects with asthma

* children age 6-17 years old (25% enrollment)
* adults 18 years and older (75% enrollment)

Exclusion Criteria:

* Pregnancy during the characterization phase
* Current smoking
* Smoking history \> 10 pack years if ≥30 years of age, or smoking history \> 5 pack years if \<30 years of age (Note: if a subject has a smoking history, no smoking within the past year),
* Other chronic pulmonary disorders associated with asthma-like symptoms, including (but not limited to) cystic fibrosis, chronic obstructive pulmonary disease, chronic bronchitis, vocal cord dysfunction (that is the sole cause of respiratory symptoms and at the PI's discretion)
* Severe scoliosis or chest wall deformities
* History of premature birth before 35 weeks gestation
* Unwillingness to receive an intramuscular triamcinolone acetonide injection.
Gait Analysis Following Total Ankle Replacement and Subtalar Fusion

Subtalar fusion is commonly performed in post-traumatic subtalar osteoarthritis, rheumatoid arthritis, posterior tibial tendon dysfunction, tarsal coalition and primary subtalar osteoarthritis. Patients with osteoarthritis or severe dysfunction involving both the ankle and the subtalar joint may benefit from an tibiotalocalcaneal fusion (TTC) or an ankle replacement and subtalar fusion. With the development of new prosthetic designs and of surgical techniques, total ankle replacements (TAR) became a reasonable alternative to fusion with functional and quality of life improvements. A gait analysis of patients that underwent TAR and simultaneous subtalar fusion allows to study with precision and reliability the ankle range of motion (ROM). On the contrary, in healthy subjects or in patients that underwent isolated TAR this is not possible because the ankle ROM is influenced by the ROM of the subtalar joint in such a way that it is not possible to analyze the two joints separately. Also, excluding the role of the subtalar joint, it is possible to accurately analyze and compare the consequences on ankle kinematics of two different prosthetic designs.

Patients who previously have underwent TAR and simultaneous subtalar fusion are retrospectively reviewed. Minimum follow-up after the surgery is 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent ankle prosthesis (Hintegra ankle system, Zimmer Trabecular Metal Total Ankle) and simultaneous fusion of the subtalar joint with at least 12 months of follow-up willing and capable of adhering to postoperative clinical protocols and functional evaluations and who have signed a specific informed consent form approved by the Ethics Committee
* Males or females aged between 20 and 80 years old.
* Patients with diagnosis of primary not-inflammatory degenerative articular disease

Exclusion Criteria:

* Patients with Body Mass Index (BMI)\> 35.
* Patients with active or suspected latent periprosthetic infection
* Patients who underwent revision surgery.
* Prosthesis of the hip, knee or ankle, homolateral or contralateral.
* Fusion failure of subtalar joint.
* Patients with chronic heart failure (NYHA stage\> 2)
* Presence of neurological disorders, neuromuscular disorders or other major musculoskeletal pathologies
* Cognitive deficits.
* Impossibility to match questionnaires due to cognitive disorders or language dysfunctional disorders
Optimization of Deep Brain Stimulation Parameters in Patients With Medically Refractory Epilepsy

Deep brain stimulation (DBS) is used to treat epilepsy in cases where patients are medically refractory and are not candidates for surgical resection. This therapy has been shown to be effective in seizure reduction, yet very few patients achieve the ultimate goal of seizure freedom. Implantable neural stimulators (INSs) have many parameters that may be adjusted, and could be tuned to achieve very patient specific therapies. This study will develop a platform for stimulation setting optimization based on power spectral density (PSD) measures.


Eligibility Criteria:
Inclusion Criteria:

* medically refractory epilepsy
* already have a deep brain stimulator in place

Exclusion Criteria:

* severe dementia at investigator discretion
Safety Extension Study of TRO19622 in ALS

The purpose of the assay is to assess the safety of TRO19622 330 mg QD as add-on therapy to riluzole 50 mg bid in the treatment of patients suffering from ALS, after completion of the preceding clinical trial (TRO19622 CL E Q 1015-1) in an open label extension.

Entry of a patient into this safety study is intended to occur immediately after the patient has finished participating in the preceding efficacy study (Protocol TRO19622 CL E Q 1015-1).

The Investigator will explain to the patients the nature of this open-label safety study, its procedures, requirements and restrictions so as to obtain their written informed consent.

Each patient will be treated with olesoxime (TRO19622) until the results of the double-blind trial become available with a maximum of 15 months.

Follow-up visits will take place every 3 months (+/- 2 weeks).

Safety assessments will be performed at all visits (every 3 months).

Eligibility Criteria:
Inclusion Criteria:

* Patients must have completed the 18-month safety and efficacy study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole (Protocol TRO19622 CL E Q 1015-1).
* Both the investigator and the patient will decide based on previous good tolerance and other clinical grounds whether or not to participate to the open-label extension.
* If patients were on anti-vitamin K during the double-blind period, when entering the open-label extension, coagulation tests should be monitored in exactly the same conditions as if a new anticoagulant treatment was initiated and the dose of anti-vitamin K should be adjusted accordingly.
* Patients enrolling from this prior safety and efficacy study must:

  * If female of childbearing age of potential, continue to use adequate birth control methods and have a negative serum pregnancy test at the preceding double-blind protocol termination visit. Male and female partners must agree to use an effective method of birth control during their participation in the trial and for at least 15 days after the last IMP dose. Both partners must use reliable methods of contraception with 2 independent methods. The following measures are acceptable: Hormone contraceptives (e.g. oral contraceptives or comparable methods), intrauterine device, condoms with spermicidal coating or in combination with spermicidal creams, total abstinence or sterilisation performed in the past.
  * Be able to follow the investigator's instructions and be able to comply with the visit schedule and visit requirements; and
  * Sign a written informed consent.

Exclusion Criteria:

Patients may not participate in this study if they have an ongoing, unresolved, clinically significant medical problem (including patients having experienced serious adverse events or non-serious, but medically significant adverse events during the preceding safety and efficacy study that was assessed to be related to the study medication by the investigator) that in the judgment of the investigator would make it unsafe for the patient to participate in the trial.
Tolerance and Patients' Satisfaction With IGHy

Primary immunodeficiencies (PID) represent more than 150 diseases affecting the immune system. More than 50% of PIDs are due to a lack or an insufficiency in antibody production. Some of these immunodeficiencies as well as some secondary immune deficiency with deficient antibody production (especially in hematology and oncology) are responsible for repeated and/or severe infections, requiring long-term replacement therapy with intravenous polyclonal immunoglobulin. Intravenous replacement therapy is administered every 21 or 28 days in hospital. Subcutaneous administration (weekly or bi-weekly) can be initiated for patients who cannot tolerate intravenous infusions or who have difficult venous access. However, some patients experience a decrease in quality of life with these more frequent administration at home. A new treatment is available in France since 2017, which is a subcutaneous infusion of human immunoglobulin facilitated by recombinant human hyaluronidase (IGHy), administered every 3 to 4 weeks in a single abdominal site, at home. No direct data are available in adults to evaluate tolerance and satisfaction with this treatment, but we know it is a preferred option in children and adolescents.

The objective of the study is to describe the continuation of the human immunoglobulin-assisted recombinant human hyaluronidase (IGHy) therapy at 6 months from the start of treatment.

The secondary objectives are to evaluate the quality of life of patients treated with human immunoglobulin-assisted recombinant human hyaluronidase (IGHy) therapy.

Eligibility Criteria:
Inclusion Criteria:

* major (\> 18 years),
* with primary or secondary immunodeficiency,
* followed in the Department of Internal Medicine, Infectious Diseases - Clinical Immunology CHU Reims.
* Benefiting from human immunoglobulin treatment facilitated by recombinant human hyaluronidase,
* agreeing to participate in the study.

Exclusion Criteria:

* patients refusing to participate in the study
* minors
Pregnancy-Related Low Back Pain and Complementary and Alternative Medicine (CAM) Treatment

This study compares three treatments for low back pain that started during pregnancy. The study hypothesizes that exercise, spinal manipulation, and a mind-body technique called neuroemotional technique (NET) equally affect pain intensity and disability associated with pregnancy-related low back pain. The study also hypothesizes that pain intensity and disability levels do not influence maternal heart rate variability (a measure of stress) and intrauterine attachment (a measure of relationship quality). Ten women will additionally provide blood and salivary oxytocin samples during pregnancy and periodically for three months after birth. These women and their babies will also be videotaped playing for 5 minutes at 2 weeks, 6 weeks, and 3 months postpartum.

Pregnancy-related low back pain is experienced by over half of all pregnant women. In the United States it is thought of as a normal constituent of pregnancy. However, in Europe low back pain associated with pregnancy is treated. In the United States pregnancy-related low back pain is thought to resolve with birth. However about 1/3 of women who experience pregnancy-related low back pain continue to experience back pain for one year postpartum. Those women whose low back pain persists into the postpartum period are more at risk of experiencing comorbidities such as postpartum depression.

In the extrauterine life maternal pain limits a mother's ability to securely attach with her child. Furthermore, interpretation of pain intensity is influenced by the type of attachment the individual has with her parents. Little is known how maternal pain may influence intrauterine attachment. Similarly, heart rate variability is influenced by pain and by spinal manipulation in non-pregnant populations. However, normal non-pregnant patterns of heart rate variability are altered during the second and third trimesters of pregnancy, and little is known about why this happens or what this means.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* 20-49 years old
* Pregnant with a singleton
* Low back pain began during pregnancy and has lasted more than one week
* Low back pain is reproducible with palpation

Exclusion Criteria:

* Health conditions such as hypertension, diabetes, cancer, thyroid condition etc.
* Pain radiates below knee
* Cannot read English
* Plans to move away from Portland area during pregnancy
* Not willing to be randomized to one of the three arms of the study
A Phase 2 Placebo Controlled, Clinical Trial Designed to Assess the Efficacy, Safety and Dose Response Characterisation of STS01 for the Treatment of Mild-moderate Alopecia Areata (AA)

A Phase 2 double-blind, multi-site, placebo-controlled, parallel-group design to assess the efficacy, safety and dose-response characterisation of STS-01 for the treatment of mild- moderate alopecia areata.

STS-01 is being developed to address the need for an effective, safe and convenient non-steroidal topical treatment for mild-moderate alopecia areata. The product builds on a mechanism with a well-established safety profile in dermatology, and existing evidence of its effectiveness in this condition through targeting key relevant cytokines. STS-01 has been modified to maximise the effectiveness of this mechanism and offer a cosmetically elegant topical cream. The study aims to assess the effectiveness, safety and dose-response characteristics of STS-01 for the treatment of mild-moderate alopecia areata.

Eligibility Criteria:
Inclusion Criteria:

1. Active alopecia areata (less than 50% SALT score, present for at least 6 months)
2. Not currently receiving treatment for hair loss
3. Eighteen years of age or more
4. Affected skin with normal appearance and no grossly evident epidermal alteration such as scaling or follicular abnormalities
Observational Study for Patients With Newly Diagnosed (MCL) Not Eligible for High-dose Therapy

This is an observational study aimed to analyze the effectiveness of treatment of patients with newly dg. mantle cell lymphoma not eligible for high-dose therapy and autologous stem cell transplantation. Scheme of treatment: alternating cycles of R-CHOP (rituximab, cyclophosphamide, hydroxydaunomycin, oncovin, prednison) and R-AraC (rituximab, cytarabin): R-CHOP / R-AraC / R-CHOP / R-AraC / R-CHOP / R-AraC. The study was proposed based on the previously published data in the younger patients, which demonstrated improved outcome after implementation of Ara-C into induction.

This is an observational study considered for patients with mantle cell lymphoma meeting the basic inclusion criteria. The study will enrol patients who will be treated according to standard protocol used in the hematologic department. Scheme of treatment: alternating cycles of R-CHOP and R-AraC: R-CHOP / R-AraC / R-CHOP / R-AraC / R-CHOP / R-AraC.

Baseline procedures:

* CT or PET-CT (positron emission tomography with computed tomography)before starting treatment, after 3 cycles and at the end of treatment (after 6 cycles)
* bone marrow examination before therapy, after 3 cycles and after completion of induction
* maintenance rituximab based of standards of each centre

The study was proposed based on the previously published data in the younger patients, which demonstrated improved outcome after implementation of Ara-C into induction.

Primary objectives include response after induction by PET-CT and PFS (progression-free survival).

Secondary objectives include OS (overall survival), and prognostic significance of minimal residual disease detection after completion of induction

Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of MCL (hematopathologic examination in the reference centre, with evidence of cyclin D1 or translocation t(11;14) )
* not eligible for high-dose therapy with autologous stem cell transplantation
* eligible for R-CHOP or R-COEP-based therapy
* signed informed consent form with the study and data processing

Exclusion Criteria:

* non compliance of a patient
* CNS (central nervous system) involvement with lymphoma
* ECOG (Eastern Cooperative Oncology Group) \>3 or active uncontrolled comorbidities
A New Approach to Cervical Cancer Prevention in Kenya

The purpose of this study is to determine if the human papillomavirus (HPV) deoxyribonucleic acid (DNA) testing, performed on self-collected vaginal swabs, is acceptable, feasible, and sensitive and specific in detection of high-grade cervical lesions among Kenyan women, compared to the current standard of care.

The purpose of this study is to test the hypothesis that effective cervical cancer screening can be performed in a high percentage of women, using HPV DNA of self-collected vaginal samples, provided by women attending either chamas (community groups) or in their own homes. HPV DNA testing will be used to triage women for a secondary screen by visual inspection with acetic acid (VIA) in a local clinic. The investigators will determine if HPV DNA testing, performed on self-collected vaginal swabs, is acceptable, feasible, and sensitive and specific in detection of high-grade cervical lesions among Kenyan women, compared to the current standard of care. In addition, women will bring their children to be vaccinated against HPV in these community meetings, using the standard of care for the approved HPV vaccine available in Kenya.

The investigators will test this approach by completing the following Specific Aims:

Specific Aim 1: Determine the percentage of women attending community meetings who will provide self-collected vaginal swabs for HPV DNA testing.

Specific Aim 2. Following HPV DNA screening using self-collected swabs, determine the percentage of these women who will attend the local clinic.

Specific Aim 3. Evaluate the statistical correlation between HPV DNA testing of self-collected vaginal swabs and VIA (as all women in this pilot study will undergo VIA).

Eligibility Criteria:
Inclusion Criteria:

1. Women who live in Kenya who are between the ages of 30 and 55, are willing to provide a self collected vaginal swab and willing to travel to the local clinic for a VIA

Exclusion Criteria:

1. current pregnancy, inability to consent due to mental or physical disability, or a medical illness that has rendered the patient unable to understand consent