cyrilzakka/clinical-trials huggingface dataset:
Patients With Tuberculosis, Mycobacteriosis or Latent Tuberculosis

In the last 30 years, tuberculosis (TB) has re-emerged in industrialised countries as a public health, with a decrease in incidence among the resident population and an increase in the burden of immigrants. Therefore, it becomes a priority to implement an effective TB control that relies on both rapid and reliable identification of active infections, with a adequate treatment and surveillance of resistance, but also on the identification of latent tuberculosis infections (ITBL) in populations at higher risk of progression to the active disease, representing a source of infection for the community.

The study is non-pharmacological and monocentric. Data from patients with clinical/radiological suspicion of mycobacteriosis or tuberculosis will be considered for which they have been received at the OU of Microbiology of the Polyclinic S.Orsola-Malpighi biological samples for mycobacteria research and/or blood samples for immunological investigations for latent tubercular infection in the period January 2012-May 2021 (retrospective part of the study); Data from patients suspected of mycobacteriosis, TB or ITBL from June 2021 to December 2026 (prospective part of the study, duration: 6 years, possibly renewable) will also be considered. The objectives of the study are: 1) Analysis of epidemiological, demographic and clinical aspects of patients with TB, mycobacteriosis non-tubercular or ITBL in the period January 2012-December 2026. 2) Assessment of diagnostic accuracy of the most frequently used methods for Microbiological diagnosis of tuberculosis (TB) or non-tubercular mycobacteriosis and immunological methods for the diagnosis of latent tubercular infection (ITBL). 3) Analysis of the microbiological characteristics (phenotypic and molecular) of MTB and NTM strains. 4) Evaluation of the clinical outcome of patients with ITBL/TB/NTM in treatment and follow-up in the post-treatment period.

Eligibility Criteria:
Inclusion Criteria:

* age of 18 years or more,
* clinical/radiological suspicion of TB or non-tubercular mycobacteriosis or ITBL for which sent to the Microbiology laboratory at least one biological sample for the mycobacteria and/or a blood sample for the IGRA test;
* Obtaining informed consent.

Exclusion Criteria:

* None
Study Protocol: Study on Incidence and Risk Factors of Mold Infections in Children During Leukemia Treatment

The study aims to evaluate the occurrence, mortality, and risk factors for invasive mold infections (IMI) in children treated with chemotherapy for acute leukemia in Denmark. The study will be a retrospective nationwide survey study of all children who received first-line chemotherapy for acute leukemia from 2008 to 2022 in Danish pediatric oncology units. The study population will include approximately 800 children under the age of 18. Data will be collected from medical records, hospital databases, and national databases. When the IMI subgroup has been identified, this will be compared to the leukemic group that did not develop IMI. Statistical analysis can then determine the occurrence, mortality rate, and possible IMI risk factors.

Chemotherapy can weaken children's immune system, making them vulnerable to infections, including invasive mold infections (IMI), caused mainly by Aspergillus spp. The at-risk population for IMI in children with acquired immunodeficiency is patients with prolonged granulocytopenia due to hematologic malignancies treated with chemotherapy or allogeneic hematopoietic stem cell transplantation (HSCT) recipients and children receiving long-term corticosteroid treatment. Incidences and mortality rates are often reported as high.

In a retrospective cohort study, we aim to obtain an epidemiological overview of IMI in children receiving first-line treatment for acute myelogenous leukemia (AML) and acute lymphoblastic leukemia (ALL) in Denmark from 2008 to 2022 and identify possible risk factors, including treatment-related adverse effects.

Objectives

1. To determine and compare the incidence of IMI in childhood AML and ALL during first-line chemotherapy in Denmark.
2. To determine and compare the mortality of IMI in childhood AML and ALL during first-line chemotherapy in Denmark.
3. To explore risk factors for IMI in childhood AML and ALL during first-line chemotherapy in Denmark.

Eligibility Criteria:
Inclusion Criteria:

* Age \<18 years at the time of inclusion
* Received first-line treatment for ALL or AML
* Treatment at a Danish tertiary pediatric oncology unit (Rigshospitalet, Aarhus University Hospital, Odense University Hospital, and Aalborg University Hospital)
* Treatment initiation January 1st, 2008, to December 31st, 2022

Exclusion Criteria:

* Not meeting inclusion criteria
Muscle Preservation Hamstring Graft for ACL Reconstruction

* Muscle derived stem cell is a better source of stem cells than a tendon tissue
* Preservation of muscle derived stem cell may enhance bone-tendon integration and ligamentization of ACL hamstring graft


Eligibility Criteria:
Inclusion Criteria:

* Primary ACL reconstruction using autogenous hamstring graft

Exclusion Criteria:

* Combined meniscal or ligament surgery
* Combined osteoarthritis (KL grade II or more)
* chondral injury more than grade 2
* Refuse to undergo MRI
V930 First in Man (FIM) Study (V930-002)(COMPLETED)

To determine the safety/tolerability, and immunogenicity of an experimental vaccine given as intramuscular injections followed by electrostimulation in cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have stages II, III, or IV breast, colorectal, ovaria, of non-small cell lung cancer
* Patients will either be disease free following primary therapy or have advanced disease with a durable response (\>3 months) after standard therapy
* Tumor antigen HER-2 and/or CEA must be measurable in the blood or detected by Immunohistochemistry staining of the biopsies obtained from the primary tumor or metastasis

Exclusion Criteria:

* Patients with prior treatment with any HER-2 and/or CEA containing vaccine
* Patients who have significant cardiac disease
* Patients with autoimmune disorders
* Patients who are pregnant or lactating
Evaluation of Intraoperative Dexmedetomidine Use in Patients Undergoing Surgical Aortic Valve Replacement

Aim of this randomized prospective study is to investigate the immunomodulatory effects of dexmedetomidine on outcomes in patients with isolated aortic stenosis after surgical aortic valve replacement.

Study will investigate effects of two different doses of dexmedetomidine on concentrations of tumor necrosis factor-α and interleukin-6, on inflammatory parameters (C reactive protein and procalcitonin) and inflammatory complications, renal function, postoperative delirium, anaesthetic and analgetic consumption and compare it to control group. It should provide a better understanding of dexmedetomidine effect on decrease of inflammatory response in patients undergoing cardiac surgery. Short-term infusion of dexmedetomidine could reduce inflammatory postoperative complications, contribute to improvement of perioperative renal function and occurrence of postoperative delirium, supporting recovery and shortening hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* isolated aortic stenosis adult patients with written consent

Exclusion Criteria:

* BMI \<30kg/m2
* 1st, 2nd and 3rd degree AV block
* bradycardia HR\<50/min upon arrival to operating theatre
* neurological disorders (Parkinson's disease, Myasthenia gravis, multiple sclerosis, brain tumors in anamnesis)
* recent use of psychoactive drugs
* alcohol and illicit drug addiction
* diabetes type I with complications
* patients who develop hypotension after initiation of dexmedetomidine infusion requiring vasoconstriction therapy
* patients receiving corticosteroids in perioperative period
* patients with known allergy to dexmedetomidine
Computerized Cognitive Exercise Training Treatment for Adults With Multiple Sclerosis

Cognitive impairment remains a major disability for individuals with multiple sclerosis (MS). The primary objective of this study is to evaluate the efficacy for treating MS-associated cognitive deficits using a unique computer-based plasticity-based and adaptive cognitive remediation treatment (PACR) compared to a computer-based control. This novel cognitive remediation approach has led to striking improvements in cognitive functioning in other disorders (schizophrenia, traumatic brain injury, aging, and dementia) but has never been applied to individuals with MS. The investigators will enroll 136 MS participants who will be randomized in a 2:1 pattern to complete either the treatment or control condition for 60 hours across a 12-week treatment period. Both the treatment and control conditions will be accessed remotely by the subjects from a study-provided laptop computer. Study outcomes will include program compliance, performance on study tasks and neuropsychological measures, quality of life and functional status. Given the success of this program with other disorders and strong preliminary data from our feasibility study, the investigators believe PACR is an exciting untapped opportunity to improve cognition in individuals with MS.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-70
* Definite MS Diagnosis, any subtype \[83\]
* Probable cognitive impairment as defined by a score ≤ 1 SD below the mean of normative data on the SDMT
* Concurrent medications to be kept constant over three months (as possible)
* No relapse or steroids in previous month
* Reading score on WRAT-3 of 37 or greater
* Visual, auditory and motor capacity to operate computer software, as judged by treating neurologist or study staff
* Willing to sign Agreement to Borrow Laptop

Exclusion Criteria:

* History of mental retardation, pervasive developmental disorder or other neurological condition associated with cognitive impairment
* Primary psychiatric disorder that would influence ability to participate
* Other serious uncontrolled medical condition (e.g., cancer or acute myocardial infarction)
* Alcohol or other substance use disorder
* History of computer-based training manufactured by Posit Science
* Learned English language after 12 years of age
Needle-Free Monitoring for IVF Patient Cycles

Salivary diagnostic testing is emerging as a less invasive, inexpensive alternative to serum analyte measurements with proven diagnostic accuracy in clinical settings. This study aims to continue analyzing aspects of the performance of salivary hormone competitive immunoassays for monitoring patient's reproductive hormone profiles in the reproductive cycle. Hormone levels will be monitored during treatment cycles for infertility.

This study will be a prospective study to measure salivary and serum estrogen and progesterone levels in subject's voluntarily undergoing monitored infertility treatment cycles including controlled ovarian stimulation (COS) with oral agents or gonadotropins and controlled ovarian hyperstimulation (COH) for in vitro fertilization (IVF). Ultimately, the potential applicability and reliability of salivary steroid monitoring in IVF cycles will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of infertility.
* Cycle start age of 25 -43 years.
* Undergoing controlled ovarian stimulation for IVF.
* All monitoring scheduled at the participating IVF facility.

Exclusion Criteria:

-Prior cancelled cycle due to hyperstimulation.
A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]

ADPKD patients who were enrolled in Study 156-05-002 will receive repeated oral administration of OPC-41061 at doses of 15 mg twice daily (morning and evening). Administration will be continued until the time of manufacturing and distribution approval of OPC-41061 for ADPKD in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Patients who completed 3-year repeated administrations and the follow-up observation or those who were withdrawn from the study due to reasons other than occurrence of adverse events (based on the judgment of either the subject or the investigator/subinvestigator) in the preceding study (156-05-002)
* Patients in whom adverse events occurring in study 156-05-002 were resolved or became stable and do not require further follow-up.

Exclusion Criteria:

* Patients with eGFR of less than 15 mL/min/1.73 m2
* Patients with any of the following complications:

  * Uncontrolled hypertension
  * Serious cardiovascular disease (eg. heart failure) or hepatic disease (eg. cirrhosis)
* Patients with any of the following complications or history thereof:

  * Clinically significant drug allergies (anaphylaxis) or hypersensitivity (especially, hypersensitivity to benzazepine derivatives or suspected hypersensitivity
  * Inability to personally give consent due to a mental illness
Improving Medication Adherence Through a Transitional Care Pharmacy Practice Model

The purpose of this pilot study is to determine if medication adherence is improved by a transitional care pharmacy practice model designed to integrate hospital and community pharmacists in the care and education of patients with heart failure or COPD who are discharged from a community hospital to home. The hospital and community pharmacists will collaborate with each other, the patient, and other practitioners including the primary care physician, nurse, and case manager to prevent and correct medication-related problems and attempt to improve patient outcomes especially during the error-prone transition from hospital to home.


Eligibility Criteria:
Inclusion Criteria:

* admitted to hospital with a primary or secondary diagnosis of heart failure or COPD
* anticipated eventual discharge to home
* agreeable to participate in monthly counseling sessions (if randomized to intervention group) from a participating community pharmacist

Exclusion Criteria:

* presence of cognitive impairment or dementia that would significantly prevent effective patient education and counseling
* non English-speaking
* anticipated discharge to a long-term care or skilled nursing facility on a permanent basis
* permanent long-term care facility residents
* surgical patients
* hospice patients
* patients who die within 30 days of initial study hospitalization
Melphalan and Filgrastim to Stimulate Peripheral Stem Cells in Patients With Multiple Myeloma

RATIONALE: Melphalan and colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood.

PURPOSE: Phase II trial to study the effectiveness of melphalan combined with filgrastim in stimulating peripheral stem cells in patients who have multiple myeloma.

OBJECTIVES:

* Determine the safety and efficacy of melphalan when used with filgrastim (G-CSF) for stem cell mobilization in patients with multiple myeloma.
* Analyze how this mobilization regimen affects parameters of stem cell (CD34+) mobilization and collection in these patients.
* Determine how this mobilization regimen affects disease status and clonotypic (i.e., tumor cell) contamination in stem cell components in these patients.

OUTLINE: Patients undergo peripheral blood stem cell (PBSC) mobilization consisting of melphalan IV on day 1 and filgrastim (G-CSF) subcutaneously beginning on day 2 and continuing until PBSC collection is complete.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 11-32 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of multiple myeloma
* Must have received induction therapy within the past 3 months
* Chemoresponsive disease

  * Greater than 50% reduction of monoclonal paraprotein with reduction in marrow plasma cell infiltrate or greater than 50% reduction in marrow plasma cell infiltrate if disease is non-secretory
* No symptomatic pleural effusions
* Eligible for stem cell transplantation

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-3 (ECOG 3 allowed only if due to bone disease or neuropathy)

Life expectancy:

* Not specified

Hematopoietic:

* Platelet count at least 150,000/mm\^3

Hepatic:

* Bilirubin no greater than 2.5 mg/dL

Renal:

* Creatinine no greater than 2.5 mg/dL OR
* Creatinine clearance greater than 51 mL/min

Cardiovascular:

* No symptomatic cardiomyopathy
* No medically documented symptomatic cardiac arrhythmias within the past 60 days
* No New York Heart Association class III congestive heart failure
* No myocardial infarction within the past 6 months

Other:

* No other concurrent medical conditions that would preclude study
* No uncontrolled infections
* No other active malignancy within the past 5 years except for non-melanoma skin cancer
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior stem cell mobilization or transplantation

Chemotherapy:

* See Disease Characteristics
* No more than 200 mg prior oral melphalan

Endocrine therapy:

* Not specified

Radiotherapy:

* No more than 3000 cGy of prior radiotherapy for myeloma

Surgery:

* Not specified
Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NDO) in Non-Catheterizing Patients With Multiple Sclerosis (MS)

This study will evaluate the safety and efficacy of OnabotulinumtoxinA (BOTOX®) for the treatment of urinary incontinence due to NDO in non-catheterizing patients with MS.


Eligibility Criteria:
Inclusion Criteria:

* At least 3 episodes of urinary incontinence over a 3-day period
* History of Multiple Sclerosis (MS)
* Urinary incontinence not adequately controlled by anticholinergic medication

Exclusion Criteria:

* Current use of intermittent catheter or indwelling catheter to manage urinary incontinence
* Previous or current botulinum toxin therapy of any serotype for any urological condition
* Previous or current botulinum toxin therapy of any serotype for any non-urological condition within the last 12 weeks
* Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or Amyotrophic Lateral Sclerosis
Equine-assisted Intervention on Psychosocial Adjustment in Patients With Psychiatric Disorders

The purpose of this study is to assess the efficacy of a brief equine-assisted intervention on the social adjustment, assertiveness, self-esteem and coping strategies in adult patients with psychosocial dysfunction, hospitalized and followed in psychiatry, as compared to standard care.


Eligibility Criteria:
Inclusion Criteria:

Patients hospitalized in psychiatry with mental disorders lasting for more than 6 months with an EGF score on the Global Evaluation of Psychosocial Functioning scale of between 31 and 60 at the time of inclusion.

Exclusion Criteria:

* acute psychiatric crisis
* severe comorbidities (such as mental retardation, mental deterioration) which could invalidate informed consent or limit patient compliance with the study protocol.
* medical contraindication to equine-assisted therapy (allergy, immunocompromised patients)
* pregnancy
* no affiliation to a social security scheme
* deprivation of liberty by a judicial decision
* wardship
* horse phobia
The Effect of Acupuncture on IVF Pregnancy Outcomes for Women With RIF

The randomized, placebo-controlled multicenter trial is conducted in five centers in China. After screening and obtaining the signed informed consent , the participants are randomly divided into two groups: acupuncture +IVF group and sham acupuncture +IVF group.


Eligibility Criteria:
Inclusion Criteria:

1. Married women aged 25-40;
2. Repeated implantation failure for unknown reasons (after 3 or more consecutive cycles of embryo transfer, or cumulative transfer of ≥6 high-quality cleavage embryos or 4 high-quality blastocysts without clinical pregnancy);
3. Transplantable Day 3 high-quality frozen embryos or frozen blastocysts (≥3BB);
4. Estrogen and progesterone replacement therapy (HRT), endometrial thickness ≥7mm on the day of endometrial transformation.

Exclusion Criteria:

Patients who met any of the following conditions were not included.

1. Those who prepare for PGD;
2. Recipients of egg donors;
3. Chromosomal abnormalities in both or one of the couples (excluding chromosome polymorphism);
4. patients with implantation failure due to known embryonic factors;
5. Uterine lesions that may affect implantation (including uterine malformation, uterine tuberculosis, history of intrauterine adhesions, submucosal fibroids, adenomyosis, \>4cm intramural fibroids)
6. Repeated spontaneous abortion (2 or more fetal loss before 28 weeks of gestation);
7. Patients with other endocrine diseases, such as thyroid disease, hyperprolactinemia, insulin resistance, diabetes, adrenal disease, etc., and poor control of hormone levels in the last 3 months;
8. Clearly diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, etc.;
9. Hydrosalpinx untreated;
10. BMI less than 18 and higher than 25kg/m2;
11. People with previous history of needle sickness;
12. Those who had previously participated in this study or had received acupuncture treatment in the past 3 months.
13. Any situation that researchers consider inappropriate for participating in this study.
Efficacy of NeoThermo-Radio-chemotherapy for LA Rectal Cancer Before Laparoscopic TME: Prospective Phase II Trial

The investigators start this prospective study to evaluate the efficacy of laparoscopic total mesorectal excision after concurrent chemo-radiation therapy with hyperthermia in locally advanced rectal cancer.

The current standard treatment of locally advanced rectal cancer is neoadjuvant concurrent chemo-radiation therapy (CCRT) followed by total mesorectal excision (TME). Recently, laparoscopic surgery is getting substitute open surgery based on the advantages of early recovery, short admission, less pain, less blood loss, and little scar without compromising oncologic outcomes.

It is reported that hyperthermia is effective in synthetic (S) phase, Low oxgen pressure, acidic, and low perfusion site which are known as radio-resistant. Because of these characteristics, it considered as the most valuable radiosensitizer in cancer treatment, theoretically. Furthermore, mild hyperthermia (41 to 41.5 ºC) can promote tumor reoxygenation.

Based on those background, the investigators start this prospective study to evaluate the efficacy of laparoscopic TME after CCRT with hyperthermia in locally advanced rectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* 20 years or older
* pathologically confirmed rectal cancer
* Eastern Cooperative Oncology Group performance status 0 to 2
* Candidate of laparoscopic TME
* Optimal bone marrow function
* Locally advanced rectal cancer confirmed by magnetic resonance imaging

Exclusion Criteria:

* Extrapelvic metastasis
* Previous pelvic irradiation
* Current status of pregnant or breast feeding
* Confirmed other malignancy within two years except thyroid cancer
The Effect of Vitamin D and Calcium Supplement on Overall Body Bone Density and Implant Stability in Posterior Maxilla

The aim of the study is to evaluate the effect of Vit D and Calcium administration on allogragt bone maturation radiographically and histomorphometercally in maxillary sinus augmentation in cases of D4 bone density.


Eligibility Criteria:
Inclusion Criteria:

* Patient with residual bone height from 5 : 8 .
* Patient with insufficient Vit D levels.
* Patient with D4 bone density.

Exclusion Criteria:

* Patients that have aproporiate amount of Ca and Vit D.
* Sinus pathology that precludes routine sinus augmentation.
* Heavy smookers patients.
* Systemic diseases that interfere with bone maturion.