cyrilzakka/clinical-trials huggingface dataset:
Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma

The primary objective of this study is to evaluate the outcome of two treatment approaches (immediate surgery or close follow-up) in patients with papillary thyroid microcarcinoma (mPTc) .

The primary objective of this study is to evaluate the outcome of two treatment approaches (immediate surgery or close follow-up) in patients with papillary thyroid microcarcinoma (mPTc) .

A further objective is to identify events associated with high risk of local recurrence and distant metastases.

Patients will be randomized to surgery or active surveillance. Patients who refuse the randomization process will be followed according to the treatment choice according to clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Age \>or =18
* Suspicious nodule \< or = or 13 mm in the maximum size of thyroid ultrasound (not older than 3 months after the screening visit)
* Cytology consistent with the TIR4 or TIR 5 class
* Sieric TSH in th standard range (with or without levo-tyroxin therapy)
* Normal string motility to fibrolaringoscopy
* Written informed consent

Exclusion Criteria:

* Ultrasound evidence of suspicious lump located on the posterior side of the lobe close to neurogene structures
* Calcitonin increase above normal levels
* Clinical or instrumental evidence of locoregional lymph node metastases (central or laterocervical compartment) or remote
* any Contraindications to surgery
Pharmacological Study of High Doses of Ceftriaxone in Meningitidis

The aim of the study is to describe the concentrations of Ceftriaxone at the steady state, in patients treated for meningitis, to determine pharmacokinetic parameters at high dose in this population. Additionally, we aimed to detect adverse effect, especially neurological trouble related to Ceftriaxone toxicity.

Day 0 : onset of treatment by Ceftriaxone, following usual therapeutic process (French Guideline) From Day 0 to Day 4 : inclusion, clinical and biological data collection, electroencephalogram at baseline.

Two samples for ceftriaxone concentration monitoring :

* Trough concentration of ceftriaxone at steady state
* A random sample (population PK) At the end of ceftriaxone treatment : assessment of tolerance and efficacy of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized adults patients,
* age equal or above 18
* Patients with Community or surgical acquired neurological infections, meningitis and others
* Prescription of ceftriaxone \>75mg/kg/d or \>4g/d -
* Subjects affiliated to French health insurance (social security)
* Informed consent form signed

Exclusion Criteria:

- Patient under guardianship
Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan

The purpose of this study is to evaluate the clinical efficacy of D9421-C 9 mg once daily compared to Mesalazine 1 g three times a day to patients with mild to moderate active Crohn's disease affecting ileum, ileocecal region and/or ascending colon as defined by a score of 180-400 on the Crohn's Disease Activity Index (CDAI) by assessment of the remission after 8-week treatment defined by a CDAI score of ≤ 150.

A multicentre, double-blind, randomised, parallel-group, Phase III study to assess efficacy and safety of D9421-C 9 mg versus Mesalazine 3 g in patients with active Crohn's Disease (CD) in Japan

Eligibility Criteria:
Inclusion Criteria:

* 15 years of age or older
* Main active disease of the ileal, ileocecal region, and/or ascending colon - - If treated with partial nutrition treatment (≤1200 kcal/day) or if treated with azathioprine (≤2.0 mg/kg/day) or 6-mercaptopurine (≤1.2 mg/kg/day), prior to randomisation until the study completion or discontinuation
* Ability to read, write and to fill a diary card and HRQL questionnaire Having mild to moderate active Crohn's disease, defined as CDAI score of 180-400 at baseline

Exclusion Criteria:

* Patient with CD lesion or status which may affect the evaluation of the efficacy (e.g. lesion only in the upper G-I, active anorectal lesion, abscess formation, stenosis, fistulae, ostomy, short bowel or other uncontrolled concomitant disease)
* Patient who need any concomitant treatment for CD that may affect the assessment for efficacy of the study drug
* Patient who need any medication which is prohibited due to suspected influence to metabolism of the study drug
* Patient who is judged to be inadequate to participate in this study from the safety point of view Patient with well-founded doubt about protocol violation
Analysis of Antihypertensive Treatment Efficacy

Analysis of antihypertensive treatment efficacy.


Eligibility Criteria:
Inclusion Criteria:

* arterial hypertension
* intake of Atacand before study enrollment

Exclusion Criteria:

* hypersensitivity to candesartan or any other ingredient of Atacand
* liver function impairment and/or cholestasis
* severe renal insufficiency (serum creatinine \> 265 µmol/L)
* Pregnant and lactating women
Advancing Community Level Action for Improving MCH/PMTCT

The goal of the ACCLAIM (Advancing Community-Level Action for Improving MCH/PMTCT) project is to increase community demand for, uptake of, and retention in Maternal and Child Health (MCH) and/Prevention of Mother-to-child transmission of HIV (PMTCT) services to improve country progress toward elimination of pediatric HIV/AIDS.

This study will undertake a three-arm randomized trial in Swaziland, Uganda and Zimbabwe. Districts/regions (n=9) with 45 PMTCT-implementing health facilities and their catchment areas (populations 7300-27500), will be randomly allocated to three intervention arms: 1) community leader engagement, 2) community leader engagement with community days, or 3) community leader engagement with community days and male and female community peer groups. The primary study outcome is HIV exposed infants (HEI) returning to the health facility within two months for early infant diagnosis (EID) of HIV. Secondary study outcomes include: gestational age of women attending for first antenatal care, male partners tested for HIV, and HEI receiving nevirapine prophylaxis at birth. Changes in community knowledge, attitudes, practices and beliefs on MCH/PMTCT will be assessed through household surveys.

Eligibility Criteria:
Inclusion Criteria:

* Must be a member of the community surveyed

Exclusion Criteria:

* Under 18 years of age
Motor and Cognitive Dual-task Gait Training Effect Functional Outcome in Intellectual Disability

To find out the comparative effects of motor and cognitive dual gait training on improving the balance control and mobility skills among intellectual disable patients.

Previous studies had done a lot of work in improving balance and mobility skills by combining both motor and cognitive dual gait training (CDT and MDT) techniques among Down syndrome, Parkinsonism and so on but not a single study was conducted in order to determine the comparative effects of CDT and MDT especially in intellectual disability individuals to improve balance so the study was conducted in order to find the comparative effect for the better understanding of the treatment effects.

Eligibility Criteria:
Inclusion Criteria:

* Both genders having IQ range between 50-69
* Walk without assistive devices
* Having a Grade I-IV on the RLACFS

Exclusion Criteria:

* Genetic disorders (Down syndrome).
* Age-related diseases like Parkinsonism and Alzheimer disease.
* Cerebrovascular accident, dementia, Cerebral palsy
* Severe visual impairment.
* Medications (sedatives or narcotics)
Evaluation of the Impact of Renal Function on the Pharmacokinetics of SIKLOS ® (DARH)

The use of hydroxyurea in sickle cell disease patients with glomerular hyperfiltration and renal failure requires a specific monitoring and dose adjustment in order to remain within the therapeutic interval while limiting the risk of toxicity or therapeutic failure. For this reason the investigators propose to compare the pharmacokinetic parameters of hydroxyurea in normal-renal function sickle cell patients to those of patients with glomerular hyperfiltration or moderate renal failure.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Male or female.
* Sickle cell disease (SS or S-β0thal) confirmed by haemoglobin electrophoresis and genotyping by deoxyribonucleic acid (DNA) analysis.
* Affiliation to a social security system.
* Having freely consented in writing after being informed of the objective, programme and potential risks incurred.

These criteria will apply to the 3 groups of sickle cell disease patients according to the renal function stage defined by the glomerular filtration rate (GFR) estimated by the formula of the Chronic Kidney Disease EPIdemiology (CKD EPI) collaboration without ethnic criterion during the last 6 months before inclusion:

* Normal-renal function: 90 ≤ GFR ≤ 130 mL/min/1.73m2 in women or 140 mL/min/1.73m2 in men.
* Moderate renal failure: 30 ≤ GFR ≤ 60 mL/min/1.73m2.
* Glomerular renal hyperfiltration: GFR \> 130 mL/min/1.73m2 in women and GFR \> 140 mL/min/1.73m2 in men.

  * Treated with hydroxyurea (Siklos®) with a stable dosage for at least one week ± 2 days before inclusion in the study and dose administered in the morning at 9:00 ± 15 minutes.

Exclusion Criteria:

* Refusal to consent.
* Patients that do not comply.
* Occurrence of vaso-occlusive crisis in the month prior to the inclusion in the study.
* Patients having had an exchange transfusion in the 15 days before inclusion in the study.
* Patients participating in another clinical trial or in the exclusion period of a previous clinical trial.
* Patients treated with a diuretic.
* Dialysis patient.
* Patients with an intercurrent disorder, especially inflammatory, that has not recovered for at least one month.
* Pregnant or breast-feeding women.
* Patients deprived of liberty or under legal protection.
* Patients who cannot understand the objective and the course of the study, incapable of giving their consent.
* In the event of severe hepatic failure.
* In the event of severe renal failure (creatinine clearance \< 30 ml/min).
* Patients who show toxic signs of bone marrow suppression.
Personality Profile of Patients With Apical Ballooning Syndrome

The investigators' hypothesis is that patients with apical ballooning syndrome (ABS) will manifest a personality profile that differs than that of a population of similar range of ethnic and socioeconomic status.


Eligibility Criteria:
Inclusion criteria:

1. Patients who have suffered with ABS
2. Adults (18 years or older)
3. Able to read English at a 6th grade level (questionnaires are self-administered and written in English)

Exclusion criteria:

1. Have withdrawn from the registry
2. Have died
Merging Yoga and Occupational Therapy for Parkinson Disease: Phase 2

The full program is focused on identifying and reducing risk factors surrounding falls. Based on previous research, we believe that occupational therapy group classes and adaptive yoga are an ideal pairing to reduce fall risk. The occupational therapy sessions will consist of lecture, group discussion, and activities designed to target biological, behavioral, environmental, and socioeconomic factors that contribute to fall risk specifically for people with Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with a diagnosis of Parkinson's disease OR their care partners
* Individuals who read and understand English
* Individuals who can stand with or without an assistive device
* People who are willing to commit to yoga practice 2x/week for 8 weeks and pay $5/class through Raintree Athletic Club (Scholarships are available if needed!)
* People who are willing to commit to group occupational therapy 2x/week for 8 weeks free of charge
* score of at least 4/6 on the short mini mental status exam

Exclusion Criteria:

* less than 18 years of age
Pilot Study of an Intimacy Enhancement Intervention for Couples Facing Breast Cancer

The central goal of this study is to examine the feasibility, acceptability, and preliminary efficacy of the IE intervention on patient and partner sexual QOL and relationship outcomes, and on patient psychosocial outcomes. We expect that the IE will show adequate feasibility, acceptability, and preliminary efficacy. Secondarily, based on the rationale that barriers exist that limit participation in intensive sexual QOL interventions for breast cancer survivors, an innovative secondary aim will investigate the perspectives of study-eligible patient candidates who opt out of participating in the pilot trial. We expect that we will be able to identify the participation barriers and intervention preferences of breast cancer survivors with sexual concerns who opt out of the intensive trial in order to inform the development of different interventions for future study.


Eligibility Criteria:
Inclusion Criteria:

1. Female
2. Age \> 21 years
3. Has diagnosis of non-recurrent stage I-III breast cancer
4. Completed active treatment (e.g., chemotherapy, radiation therapy, surgery) 6 months-5 years ago (current use of endocrine therapy is acceptable)
5. Has a partner or spouse who is \> 21
6. Lives with a romantic partner \> 6 months
7. Score of \> 3 on Patient Care Monitor Sexual Concerns screening item
8. No hearing impairment in patient or partner

Exclusion Criteria:

1. Not able to speak English, as stated in medical record or as observed by study team member
2. ECOG Performance score \> 2 OR too ill to participate as judged by physician/in medical record
3. Overt cognitive dysfunction or psychiatric disturbance such as suicidal ideation or severe mental illness, as observed or judged by the researcher, referring source, or other qualified observer.
4. Past history of any cancer other than non-melanoma skin cancer
5. Currently participating in couple/marital therapy
6. Currently pregnant
Carbohydrate Quality and Its Impact on Sleep and Depression in Type 2 Diabetes

The aim of this study was to evaluate the effect of carbohydrate quality on sleep quality and depression in patients with Type 2 diabetes. Data were collected from 150 patients with Type 2 diabetes mellitus using a demographic structure questionnaire, the Sleep Quality Scale (SQS), the Depression, Anxiety, and Stress Scale (DASS), and a Food Consumption Frequency Form. The data were analyzed using SPSS 26.

Objective: The aim of this study was to evaluate the effect of carbohydrate quality on sleep quality and depression in patients with Type 2 diabetes.

Method: A total of 150 individuals with Type 2 diabetes were included in the study. A demographic questionnaire, the Sleep Quality Scale (SQS) (where a higher SQS score indicates lower sleep quality), and the Depression Anxiety and Stress Scale were administered to the participants. Additionally, data on the frequency of food consumption for 132 foods were obtained from the participants. To determine the Carbohydrate Quality Index (CQI) score, each of these four components (fiber intake, whole grain ratio, glycemic index, and total carbohydrate ratio) was evaluated on a scale of 1 to 5 points. The score for each component was then calculated, with Q5 indicating the best and Q1 indicating the worst carbohydrate quality. The data were analyzed using SPSS 24 software.

Detailed Description: This study will evaluate carbohydrate quality index ranges (Q1-Q5), sleep quality scale score, depression, stress, anxiety score, body mass index, diabetic age, sleep duration, body weight, daily macro and micro nutrients.

Conclusion: Results will be analyzed and interpreted after data collection is completed, and conclusions will be drawn accordingly.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 19 to 64 years
* Diagnosed with Type 2 diabetes mellitus
* Voluntary participation

Exclusion Criteria:

* Patients with cancer
* Pregnant and lactating women
* Individuals with alcohol or drug addiction
* Individuals diagnosed with psychiatric or neurological disorders
Evaluation of the Coagulation Profile by Thromboelastography in Bariatric Patients

thromboelastography can identify alteration in the coagulation profile in bariatric patients who undergo sleeve gastrectomy or gastric bypass


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing bariatric surgery

Exclusion Criteria:

* none
Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid Arthritis

The purpose of this study is to determine the safety and tolerability of PRTX-100 when various doses are given 5 times at weekly intervals to patients with active rheumatoid arthritis that are taking methotrexate or leflunomide. The drug is administered in a physician's office via an intravenous infusion. PRTX-100 may be effective in rheumatoid arthritis by suppressing the immune responses.

PRTX-100 is a highly-purified bacterial protein called Staphylococcal Protein A. In this study, cohorts of patients with active RA will receive sequentially higher doses of PRTX-100. There will be an inactive placebo cohort for comparison. Patients who do not attain low RA disease activity, by a commonly used measure, will leave the study at 3 months after their first dose of study drug.


Eligibility Criteria:
Inclusion Criteria:

* Active RA with disease duration of not less than 6 months
* Concomitant stable methotrexate or leflunomide therapy

Exclusion Criteria:

* Diagnosis of any other inflammatory arthritis
* ACR Functional Classification of IV
* Significant systemic involvement secondary to RA (except for secondary Sjogren's syndrome)
* History of clincally significant hypogammaglobulinemia, common variable immunodeficiency, or humeral immunodeficientncy
* History of active tuberculosis, pro-thrombotic disorder, venous thrombosis requiring anti-coagulation, substance abuse, or serious psychiatric condition
* History of allergy or hypersensitivity to aspirin or non-steroidal cyclooxygenase inhibitors, Staphylococcal protein A
* History or presence of malignancy (except for surgically treated basal or squamous cell carcinoma of the skin at least 3 months prior to the start of study medication)
* Uncontrolled diabetes or Type 1 diabetes
* Unstable ischemic heart disease
* Serious active or recurrent infection, hepatic cirrhosis, or other medically unstable condition
* Systemic autoimmune diseases other than RA (such as systemic lupus erythematosus, scleroderma, inflammatory bowel disease, inflammatory myopathy)
* Positive for HIV, hepatitis B surface antigen, or hepatitis C antibody
* Pregnant or nursing females
* Inadequate hepatic, renal, or hematologic function
* Receipt of live vaccine within 5 weeks of start of study medication
* Concomitant administration of other biologic or non-biologic DMARDS, corticosteroids, or anti-CD20 antibodies
First in Man Clinical Study to Investigate Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of CM3.1-AC100

A first time in man, phase I study to assess the safety, tolerability and pharmacokinetics of single ascending doses of CM3.1-AC100 in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent prior to any study specific procedures
* Body weight between 60.0 to 100.0 kg (both inclusive) and BMI 19 to 29.9 kg/m2 (both inclusive)
* Judged as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination)

Exclusion Criteria:

* Any history or presence of a clinically relevant disease as judged to be relevant by the Investigator
* Blood donation within 3 month before administration of the IP
* Have a history of hypersensitivity to the IP or any of the excipients or to medicinal products with similar chemical structures
GITMO AML/MDS-Relapse Registry Study

The proposal arises from the increasingly pressing need to have a program of therapy for the prevention of relapse after allogeneic transplantation in patients with acute myeloid leukemia or myelodysplasia, especially if they undergo transplantation with positive minimal residual disease. These therapeutic approaches include molecular target drugs (for example, FLT-3 inhibitors when this gene lesion is present) or apoptosis inducers in combination with hypomethylating agents (for example, the combination of venetoclax and azacitidine or decitabine) or adoptive immunotherapy (for example, with infusion of donor lymphocytes).

To date, most of these therapeutic approaches are used in the phase of hematological relapse of the disease; less often they are used in the phase of persistence of minimal residual disease at the molecular level or in the phase of loss of molecular chimerism on CD34+ cells, also due to the prescribing constraints of the competent authorities (AIFA). It is believed that the collection of the Italian experience can provide important information on the use of different therapeutic platforms, in different settings. This information could be the starting point for the design of prospective and multicenter studies to be proposed in the near future.


Eligibility Criteria:
Inclusion Criteria:

* All patients with AML and MDS who underwent allo-SCT from 2015 to 2021, who relapsed and received salvage therapy for the relapse.

Exclusion Criteria:

* Patients with a diagnosis other than AML and MDS transplanted in the same period.
Seroepidemiological Study of Pertussis and Other Infectious Diseases

Serum samples will be corrected twice from the same youth subjects with one year interval.

Seroincidence of pertussis will be estimated by the elevation of Ig-G-PT in paired sera from an identical individual.

The relationship between the incidence and the demographic data or medical history of the subjects will be discussed.


Eligibility Criteria:
Inclusion Criteria:

* Students of junior high school, high schools or college in Gifu prefecture
* Students who can have the second blood drawing one year later
* Students (and their parent when students are underage) whose written consent is obtainable.

Exclusion Criteria:

* None