cyrilzakka/clinical-trials huggingface dataset:
Diabetes Control and Complications Trial (DCCT)

Background. Long-term microvascular and neurologic complications cause major morbidity and mortality in patients with insulin-dependent diabetes mellitus (IDDM). We examined whether intensive treatment with the goal of maintaining blood glucose concentrations close to the normal range could decrease the frequency and severity of these complications.

Methods. A total of 1441 patients with IDDM -- 726 with no retinopathy at base line (the primary-prevention cohort) and 715 with mild retinopathy (the secondary-intervention cohort) were randomly assigned to intensive therapy administered either with an external insulin pump or by three or more daily insulin injections and guided by frequent blood glucose monitoring or to conventional therapy with one or two daily insulin injections. The patients were followed for a mean of 6.5 years, and the appearance and progression of retinopathy and other complications were assessed regularly.


Eligibility Criteria:
Eligibility Criteria:

* The major criteria for eligibility included insulin dependence, as evidenced by deficient C-peptide secretion; an age of 13 to 39 years; and the absence of hypertension, hypercholesterolemia, and severe diabetic complications or medical conditions. To be eligible for the primary-prevention cohort, patients were required to have had insulin dependent diabetes mellitus (IDDM) for one to five years, to have no retinopathy as detected by seven-field stereoscopic fundus photography, and to have urinary albumin excretion of less than 40 mg per 24 hours. To be eligible for the secondary-intervention cohort, the patients were required to have IDDM for 1 to 15 years, to have very-mild to moderate nonproliferative retinopathy, and to have urinary albumin excretion of less than 200 mg per 24 hours.
Thermal Imaging for Evaluation of the Cervix

When screening results for cervical premalignant lesions are positive, colposcopy is recommended. This is highly sensitive screening method. However, specificity of the test is of low.

Thus, a technology that improves the accuracy of the colposcopic exam is needed.

This is a feasibility study with the goal of examining the performance of a thermal imaging camera in the detection of cervical malignant and premalignant lesions.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Women with premalignant cervical lesions who are candidates for conization (group A)
* Women with a normal cervix who are candidates for hysterectomy (group B)
* Women with newly diagnosed cervical cancer

Exclusion Criteria:

* For group A and B - women that had conization in the past
De Tethering Exercises for Scolisis

This study aimed to investigate the effect of Detethering exercises on muscle tone in patients with adolescent idiopathic scoliosis.

H1: Detethering exercises affect muscle tone in patients with adolescent idiopathic scoliosis.

This study is planned to include 15 patients diagnosed with adolescent idiopathic scoliosis.

Muscle tone and trunk rotation degree will be measured before and after the application of detethering exercises.

Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 10-30,
* Being diagnosed with IS
* Cobb angle between 20º and 50º,
* To be able to continue the program to be implemented,
* No chronic disease requiring the use of any neurological or psychiatric medication,
* Parents and/or child volunteering to participate in the study.

Exclusion Criteria:

* The patient has any contra-indication for exercise,
* Previous spine surgery,
* Having a curve with an apex thoracic 6 and above,
* The presence of any mental problem,
* Scoliosis is not idiopathic but has different causes (neurological, congenital, etc...), neurological, psychiatric, muscular, rheumatic or orthopedic diseases are present.
Dance Workshop for Institutionalized Seniors With Behavioral and Psychological Symptoms of Dementia

It is estimated that the prevalence of dementia in France is 5% for people over 65 years of age and that this increases to 18% for people over 75 years of age. Behavioral disorders are frequent in patients with dementia and are the main cause of institutionalization, representing up to 50% of cases. Dementia syndromes can be translated into behavioral and psychological symptoms of dementia (BPSD), which are defined as perceptual, mood or behavioral disorders. To date, there is no cure for dementia, but certain measures can be taken to reduce symptoms. The HAS suggests that physical exercise would reduce BPSD and could improve the ability to perform activities of daily living or slow down the cognitive decline of this type of patient. Indeed, several articles have highlighted the benefits of physical activity in demented patients. A meta-analysis has shown a significant decrease in BPSD via the Neuropsychiatric Inventory (NPI) score. Nevertheless, it is often observed that there is a difficulty in adhering to the program in very elderly population groups. Dance is a complete physical activity that integrates physical, cognitive and social elements. A meta-analysis has shown that dance has a significant effect on global cognition but also on neuroplasticity and physical functioning in patients with mental disorders. The music component of dance also has an effect on the behavioral problems of demented patients, stimulating language ability and social and emotional function.

However, at present, no study of good methodological quality has been able to demonstrate the effectiveness of dance-based physical activity for the treatment of dementia symptoms. As a result of these findings, the APAISE project was developed and should help slow the onset of BPSD in patients with dementia.


Eligibility Criteria:
Inclusion Criteria:

1. Institutionalized patient (male or female) over 65 years of age ;
2. Patient with behavioral problems, as measured by an NPI-ES \> 3 on any item and an NPI-ES impact scale \> 2 ;
3. Patient able to mobilize the upper body at a minimum (arms, trunk, head);
4. Medication (antipsychotics, antidepressants, anxiolytics and related hypnotics) without major modification for at least 30 days prior to inclusion after medical advice;
5. Possibility of including patients under guardianship or curatorship;
6. Patient affiliated to a social security plan;
7. Obtaining consent from the patient or legal representative.

   Exclusion Criteria:
8. Inability of the patient to follow the sessions (e.g., major visual/auditory disabilities), difficult follow-up, or any other reason at the discretion of the investigator;
9. Inability of the health care team to complete the NPI-ES questionnaire for the patient;
10. Patient has a concurrent psychiatric disorder (e.g., bipolar disorder, schizophrenia, or other).
Depression and Fatigue in MS Patients Treated With Betaferon.

This study aims to evaluate the occurence and severity of fatigue and depression in multiple sclerosis patients and the impact of Betaferon treatment on symptoms alterations.

The study is conducted in routine practice setting hence no interference with standard care takes place.

Pharmacologic treatments of MS-fatigue and depression will also be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Relapsing-remitting multiple sclerosis
* Age 18+
* Patients initiating Betaferon treatment

Exclusion Criteria:

* Patients previously treated with any immunomodulatory drug
Batch n ° 2 of the Public Market Evaluation "Medico-economic Demonstrator IsereADOM"

The goal of this study is to evaluate the health and social benefit of innovative management - IsereADOM - versus conventional follow-up in patients with heart failure.

There is a medico-economic goal too, is to perform a cost-utility analysis of the service bundle (IsereADOM) versus conventional 6-month community-based follow-up in a population with heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with heart failure confirmed by a cardiologist ;
* Patient with functional NYHA II, III, IV staining ;
* Patient domiciled in the department of Isère ;
* Patient who can be followed regularly for 6 months ;
* Patient who can benefit from RESIC-type health education ;
* Presence of a caregiver referent of proximity (family or other) according to appreciation of the investigating doctor in case of cognitive disorders ;
* Patient affiliated with social security or beneficiary of such a scheme ;
* Patient able to read, write and understand French ;
* Patient having signed informed consent to participate.

Exclusion Criteria:

* Patient with peritoneal dialysis or haemofiltration ;
* Patient with severe co-morbidity with poor short-term prognosis: mortality \< 6 months ;
* Patient with future surgical etiologic treatment: prosthetic valve, revascularization procedure, TAVI or MITRACLIP ;
* Patient residing in a nursing home or institution for dependent person ;
* Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all persons protected: pregnant woman, parturient, mother who is breastfeeding, person deprived of liberty by judicial or administrative decision, person subject of a legal protection measure).
Expanded Access to Telisotuzumab Vedotin

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Telisotuzumab vedotin prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility Criteria:
Inclusion Criteria:

- The participant must not be eligible for a telisotuzumab vedotin clinical trial.
Exploratory Study of Farletuzumab to Treat Resectable, Non-functioning Pituitary Adenomas

The purpose of this study is to evaluate whether therapy with farletuzumab is effective and safe in the treatment of resectable, non-functioning pituitary adenomas.

Non-functioning pituitary adenomas are the most frequent type of pituitary tumors, defined by the lack of hormonal overproduction from the tumor. Non-functioning macroadenomas are \> 1 cm in size that can cause progressive visual loss, headaches, and symptoms of pituitary dysfunction (hypopituitarism and/or hyperprolactinemia). Initial treatment for these type of tumors is trans sphenoidal surgical resection. In cases where the outcome is incomplete surgical resection of the tumor, repeat surgery and external beam radiation therapy may be performed. Previous clinical work suggests there may be a role for a folate receptor in the treatment of non-secretory, pituitary adenomas. MORAb-003 is a monoclonal antibody that has the potential to be an effective agent against resectable, non-functioning pituitary adenomas. MORAb-003 has been shown to be well tolerated. This study allows the opportunity to determine if therapy with farletuzumab is effective and safe.

Eligibility Criteria:
Inclusion Criteria:

* Males and females \>18 years old
* Diagnosis of non-functional pituitary adenoma
* Able and willing to undergo surgical resection of the pituitary tumor
* Significant medical conditions must be well-controlled and stable for at least 30 days prior to signing the informed consent form

Exclusion Criteria:

* Presence of clinically significant pituitary apoplexy
* Presence of hormone-secreting adenomas
* Presence of compressive optic neuropathy due to pituitary tumor
* No prior surgical, medical, or radiation therapy in the last 6 months
FOLCROM Trial: Foley Catheter in Rupture of Membranes

Multicenter randomized clinical trial comparing oxytocin versus oxytocin and foley catheter for induction in women who present with premature rupture of membranes who are not in labor.

This is a prospective, randomized, multi-center clinical trial to test the hypothesis that in women with term and near term premature rupture of membranes (PROM), an intrauterine Foley catheter plus oxytocin infusion will decrease the mean time from induction to delivery by 2.5 hours as compared to oxytocin alone.

Eligibility Criteria:
Inclusion Criteria:

1. Spontaneous rupture of membranes (ROM) ≥1 hour prior to starting induction; ROM defined as clinical history with the presence of 2 of the following 4: pooling, ferning, nitrazine, oligohydramnios. In the absence of clinical history, oligohydramnios AND pooling must be present for ROM to be diagnosed. Oligohydramnios is defined as a total amniotic fluid index of \<5cm or a maximum vertical pocket \<2cm.
2. Unfavorable cervix, defined as sterile digital exam ≤ 2cm dilated / 80% effaced
3. Gestational age ≥ 34 weeks by best obstetric estimate
4. Clinical management decision is vaginal delivery
5. Singleton gestation
6. Cephalic presentation
7. Willing to participate and able to understand and sign the informed consent document before randomization
8. Women of reproductive age

Exclusion Criteria:

1. Multiple gestations
2. Lethal fetal anomalies, e.g., anencephaly, trisomy 13, trisomy 18
3. Latex allergy
4. Greater than 1 prior cesarean delivery
5. Active labor - defined as contractions more frequent than every 5 minutes (or ≥ 12 contractions in 1 hour) associated with ≥ 1 cm cervical change. In the absence of ≥ 1 cm cervical change after 2 hours, patients with contractions can be included in the study.
6. Suspicion of chorioamnionitis
7. Any contraindications to vaginal delivery, including malpresentation, active herpes, complete placenta previa, greater than two prior cesarean deliveries, etc.
8. HIV positive status or AIDS
9. Intrauterine fetal demise
10. Suspected placental abruption, significant hemorrhage
11. Nonreassuring fetal heart rate (FHR) pattern
12. Participation in a competing trial
Evaluation of Pharmacokinetic / Pharmacodynamic and Tolerance Assessment of Dermal Administration of Beta-lactams in the Elderly

The route of subcutaneous administration of drugs has become a common practice in some specialties (palliative care, geriatrics).

This is an alternative to oral, sublingual, rectal or intravenous Many drugs are used by subcutaneous route but few clinical studies evaluating the level of scientific relevance justifies their use.

The purpose of this study is to assess:

1. / Determine that there is no difference between the subcutaneously compared to intravenous administration in terms of dosage and serum PK / PD of Beta lactam objectives in a geriatric population.
2. / The safety and lack of toxicity of administrations subcutaneously.

Advantages disadvantages

* easy Of establishment
* Simplicity Monitoring and manipulation
* Reduced Risk of infection
* No Risk of venous thrombosis
* Lower cost Simple -Technique for support at home taking
* Limitation Aggressive gestures
* multiplicity Of all possible injection sites
* Technique Of choice for agitated patients or confused -Risk of localized edema (\<1000mL / 24 / site)
* Use Impossible for some drugs
* Risk Discomfort and intolerance at the injection site

A practical study was conducted among 382 physicians (289 geriatricians and 93 infectious disease specialists). Among them 97.5% reported regular use of the subcutaneous route for the administration of antibiotics.

Declarative criteria pretend curb the use of this route was the lack of data Pk / Pd (61.2%); the absence of marketing authorization for the subcutaneous route (34.5%); the absence of serum assay available (2.1%).

PROTOCOL

Primary objective :

• Determine that there is no difference between the subcutaneously compared to intravenous administration in terms of dosage and serum PK / PD objectives Beta lactam in a geriatric population.

Secondary objectives:

* Clinical evaluation at J14 and J90 (healing, death)
* Clinical tolerance of subcutaneously by self-assessment or hetero-evaluation of the existence of cognitive disorders

Monitoring of antibiotic dosages:

* Making systematic assay serum concentrations of residual antibiotics in the range of 30 min prior to reinjection H24 after starting treatment and then weekly monitoring.
* Realization of the assays according to the method of Liquid Chromatography-Mass Spectrometry (LC-MS)

Patient monitoring of J1-J14:

• Clinical monitoring and biological usual

Eligibility Criteria:
Inclusion Criteria:

* Geriatric Population (≥ 75 years)
* Infection may cause bacteremia or not: Gram-negative bacilli and gram-positive cocci susceptible to beta-lactam

Exclusion Criteria:

* Patient Refusal expressed or legal guardian
* polymicrobial infection
Evaluation of Mammographic Breast Density in Participants with Hormone Receptor-Negative Breast Cancer Enrolled on Study A011502

This phase III trial evaluates mammographic breast density in participants with hormone receptor-negative breast cancer enrolled on study A011502. High breast density has been shown to be a strong risk factor for developing breast cancer and decreasing breast density may decrease the risk for breast cancer. Participants treated with aspirin may show reduced breast density on a mammogram.

PRIMARY OBJECTIVES I. To compare the 1-year mammographic breast density in the contralateral (unaffected) breast between the aspirin and placebo arms in patients with hormone receptor negative or positive breast cancer enrolled in A011502.

SECONDARY OBJECTIVES I. To compare the 2-year mammographic breast density in the contralateral (unaffected) breast between the aspirin and placebo arms in patients with hormone receptor negative or positive breast cancer enrolled in A011502.

OUTLINE:

Participants provide bilateral screening mammogram taken prior to all cancer treatment and within 8 weeks prior to registration to A011502 and an annual bilateral mammogram as near as possible to 1 year post-registration to A011502 and as near as possible to 2 years post-registration to A011502. Participants also undergo collection of blood sample and menstrual cycle data within 2 weeks after registration and at 1 and 2 years after registration to A011502.

After completion of study, participants are followed up annually until 10 years from registration to study A011502.

Eligibility Criteria:
Inclusion Criteria:

* Must be either concurrently enrolling or previously enrolled to Alliance A011502. Eligible patients may be either pre- or post-menopausal.
* Patients must have either hormone receptor-negative breast cancer or be ER+ patients who have completed hormone therapy (e.g., tamoxifen, aromatase inhibitors) at least 6 months prior to registration to A011502.
* Patients must have baseline breast density measurement as defined by one of the following:

  * \>= 25% breast density, or
  * Scattered areas of fibroglandular density, or
  * Breast composition category b, c, or d, per Breast Imaging Reporting and Data System (BI-RADS) 2013.
* Baseline digital screening mammogram (mediolateral \[MLO\] and craniocaudal \[CC\] views) taken prior to registration must be available for submission.

  * For patients enrolling concurrently with Alliance A011502: Baseline digital screening mammogram must be taken within 8 weeks prior to registration to A211601. If a baseline mammogram within 8 weeks is not available, a new screening mammogram must be performed prior to treatment on Alliance A011502
  * For patients enrolling retrospectively: The patient's previous routine mammogram on file must be within 1 year prior to registration to A011502.
* Contralateral unaffected breast in place (with no prior cancer or radiation, no implants and no plan for breast surgery on contralateral breast over the course of the study). Patients with a prior biopsy on the unaffected breast are eligible.
* Not pregnant and not nursing.
A Study of Immediate 9 Months Adjuvant Hormone Therapy With Triptorelin 11.25 mg Versus Active Surveillance After Radical Prostatectomy in High Risk Prostate Cancer Patients.

The purpose of this study is to assess the benefit of immediate hormonal treatment after Radical Prostatectomy in Chinese and Russian patients with high risk prostate cancer. To reach this target, the trial will compare a group of patients treated with triptorelin at 8 weeks after the surgery and for a duration of 9 months (3 injections) versus another group (called "active surveillance group") who will be not receiving triptorelin. Both groups will be followed every 3 months to monitor any sign of disease progression during a minimum of 36 months

This trial is a phase IV (in Russia and China) as approved indication is locally advanced or metastatic prostate cancer in both countries.

Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed adenocarcinoma of the prostate
* Radical Prostatectomy with curative intent performed no more than 8 weeks before randomisation
* High risk criteria of disease progression, defined as follows:

Gleason score ≥8 on prostatectomy specimen, and/or Pre RP PSA level ≥20 ng/mL, and/or Primary tumour stage 3a (pT3a) (with any PSA level and any Gleason score)

* Post-RP PSA levels ≤0.2 ng/mL at 6 weeks

Exclusion Criteria:

* Evidence of lymph nodes or distant metastasis
* Positive margins
* Evidence of any other malignant disease, not treated with a curative intent
* Had surgical castration
Effect of the Home-based Digital-assisted Dyadic Tai Chi (HDTC) Training Program on Cardiac Function Among Sedentary Individuals With HF and Care Burden of Their Caregivers: a Randomized Controlled Trial

The proposed study aims to assess the effectiveness of the HDTC training program in improving cardiac function and secondary outcomes among sedentary heart failure individuals, while simultaneously reducing care burden and improving other outcomes for their caregivers.

This is a two-arm parallel, single-blinded randomized controlled trial. A total of 118 HF individuals and 118 caregivers will be enrolled and allocated to the HDTC group and the control group in a 1:1 ratio. Participants in the control group will receive usual care. Those in the HDTC group will also attend the HDTC training program, including a 30-minute educational seminar, a 1-hour dyadic coaching session, and 12-week Tai Chi training. Data on cardiac function, exercise tolerance, exercise self-efficacy, fear of activity, sedentary behavior, hospital admission, health-related quality of life, depression, anxiety, stress, and mutuality for HF individuals, as well as care burden, quality of life, depression, anxiety, stress, and mutuality of caregivers, will be collected at baseline (T0), 4 weeks (T1) and 12 weeks (T2) after the intervention. The intention-to-treat analysis (ITT), modified ITT analysis, and per-protocol analysis will be conducted. The generalized estimating equation (GEE) model will be used to measure changes in outcome variables.

Eligibility Criteria:
Inclusion Criteria:

* HF individuals:

  * aged 18 to 75 years
  * diagnosed with CHF based on the Chinese Guidelines for Diagnosis and Treatment of Heart Failure 2024
  * categorized as NYHA class I, II or III
  * 6MWD \>150 meters (mild to moderate HF)
  * stable phase of disease in the past four weeks and capable of independently practice Tai Chi without any musculoskeletal disorders that may impede joint movement
  * sit more than 8 h/d in the past month
  * own a smartphone
  * volunteer to participate and provide informed consent.
* caregivers:

  * age ≥18 years old
  * primary caregiver at home, who has emotional ties or social obligations with HF individuals and provides daily care
  * able to exercise Tai Chi without help
  * volunteer to participate and provide informed consent.

Exclusion Criteria:

* HF individuals:

  * plan to undergo surgery within the next 6 months
  * have severe comorbidities, such as cancer, liver or kidney failure, or diagnosed psychiatric disorders
  * plan to be admitted to a nursing home or other care facilities
  * regularly practice Tai Chi or engaging in other forms of exercise in the past 3 months (at least 3 times per week, at least 20 minutes of regular exercise each time)
  * currently participate in similar or related studies.
* caregivers: · formal caregivers, such as nurses, will be excluded.